[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38806-38989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17837]
[[Page 38805]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 304, et al.
Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP)
Systems; Final Rule
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules
and Regulations
[[Page 38806]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417
[Docket No. 93-016F]
RIN 0583-AB69
Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule with request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is establishing
requirements applicable to meat and poultry establishments designed to
reduce the occurrence and numbers of pathogenic microorganisms on meat
and poultry products, reduce the incidence of foodborne illness
associated with the consumption of those products and provide a new
framework for modernization of the current system of meat and poultry
inspection. The new regulations (1) require that each establishment
develop and implement written sanitation standard operating procedures
(Sanitation SOP's); (2) require regular microbial testing by slaughter
establishments to verify the adequacy of the establishments' process
controls for the prevention and removal of fecal contamination and
associated bacteria; (3) establish pathogen reduction performance
standards for Salmonella that slaughter establishments and
establishments producing raw ground products must meet; and (4) require
that all meat and poultry establishments develop and implement a system
of preventive controls designed to improve the safety of their
products, known as HACCP (Hazard Analysis and Critical Control Points).
DATES: Effective Date: July 25, 1996, however these rules are not
applicable until the dates listed below.
Applicability dates: (1) The HACCP regulations set forth in 9 CFR
Part 417 and related provisions set forth in 9 CFR 304, 327, and 381
parts will be applicable as follows:
In large establishments, defined as all establishments
with 500 or more employees, on January 26, 1998.
In smaller establishments, defined as all establishments
with 10 or more employees but fewer than 500, on January 25, 1999.
In very small establishments, defined as all
establishments with fewer than 10 employees or annual sales of less
than $2.5 million, on January 25, 2000.
(2) The Sanitation SOP's regulations set forth in 9 CFR 416 will be
applicable on January 27, 1997.
(3) The E. coli process control testing regulations set forth in 9
CFR 310.25(a) and 381.94(a) will be applicable on January 27, 1997.
(4) The Salmonella pathogen reduction performance standards
regulations set forth in 9 CFR 310.25(b) and 9 CFR 381.94(b) will be
applicable simultaneously with applicability dates for implementation
of HACCP.
Comments: Comments on specified technical aspects of the final
regulations must be received on or before September 23, 1996. With
respect to the HACCP final regulations, FSIS requests comments by
November 22, 1996.
ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, DOCKET #93-016F, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 4352, 1400 Independence
Avenue, S.W., Washington, DC 20250-3700. All comments submitted on this
rule will be available for public inspection in the Docket Clerk's
Office between 8:30 a.m. and 1:00 p.m., and 2:00 p.m. and 4:30 p.m.,
Monday through Friday. The references and baseline surveys cited in
this document are available for inspection in the FSIS Docket Room.
FOR FURTHER INFORMATION CONTACT: (1) GENERAL: Dr. Judith A. Segal,
Director, Policy, Evaluation, and Planning Staff, (202) 720-7773; (2)
MICROBIAL TESTING: Patricia F. Stolfa, Acting Deputy Administrator,
Science and Technology, (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Obtaining Copies of This Document:
An electronic version of this document is available on the Internet
from the Federal Register at www.access.gpo.gov/su__docs/aces/
aces140.html. Paper or diskette copies of this document may be ordered
from the National Technical Information Service (NTIS), U.S. Department
of Commerce, 5285 Port Royal Road, Springfield, VA 22161. For a
complete copy of this document orders must reference NTIS accession
number PB96-177613 (paper copy) and PB96-502166 (disk copy). For a copy
of the preamble and rule, the individual appendices, and the impact
assessment reference the following NTIS accession numbers: PB96-177621
(preamble and rule only), PB96-177639 (Appendix A), PB96-177647
(Appendix B), PB96-177654 (Appendix C), PB96-177662 (Appendix D), PB96-
177670 (Appendix E), PB96-177688 (Appendix F), PB96-177696 (Appendix
G), and PB96-177704 (impact assessment). For telephone orders or more
information on placing an order, call NTIS at (703) 487-4650 for
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with a modem or Telnet fedworld.gov to access this document
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assistance to access FedWorld, call (703) 487-4608.
Table of Contents
I. Background
Overview of FSIS Food Safety Goal and Strategy
FSIS Regulatory Proposals
FSIS Regulatory and Inspection Reform Plans
Change Within FSIS
The FSIS Pathogen Reduction/HACCP Rulemaking Process
Seven Information Briefings
Three Scientific and Technical Conferences
Public Hearing
Federal-State Relations Conference
Scoping Session and Six Issue-Focused Meetings
Food Safety Forum
Farm-to-Table Strategy
General Overview of the Comments and the Final Rule
HACCP and Performance Standards
Sanitation SOP's, Antimicrobial Treatments, and Cooling
Requirements for Raw Meat and Poultry Products
Timetable for Implementation
Federally Inspected Establishments
State-inspected Establishments
Foreign-inspected Establishments
Implementation Conferences
Request for Comments
II. Hazard Analysis and Critical Control Point Systems
Overview of Final Rule
History and Background of HACCP
The Seven HACCP Principles
HACCP and the FSIS Food Safety Strategy
Preparing for HACCP Implementation
Inspection under HACCP
Implementation Schedule
Small Business Issues
Training Considerations
Mandatory versus Voluntary HACCP
HACCP from Farm-to-Table
Total Quality Control (TQC) Establishments and HACCP
Freedom of Information Act Concerns
FSIS Enforcement Authority and Whistleblower Protection
Enforcement and Due Process
The Final Rule
Reorganization of HACCP Regulatory Text
HACCP Systems as a Condition of Receiving Inspection
Definitions
Hazard Analysis and HACCP Plan
Corrective Actions
Validation, Verification, and Reassessment
Reassessment
FSIS Verification
Records
[[Page 38807]]
Training
Adequacy of HACCP Plans
III. Sanitation Standard Operating Procedures
The Proposed Rule
The Final Rule
Comments and Responses
General
Development of Sanitation SOP's
Maintaining Sanitation SOP's
Recordkeeping
``Layering''
Role of Inspectors
Relation to HACCP
Training
Pre-operation Sanitation Inspection
Implementation Date
IV. Microbiological Performance Criteria and Standards
Summary of Proposal
Role of Microbiological Performance Criteria and Standards in
FSIS Food Safety Strategy
Overview of Final Rule
Process Control Verification Performance Criteria
Pathogen Reduction Performance Standards
Process Control Verification: E. coli Performance Criteria and
Testing
Rationale for Using E. coli Tests to Verify Process Control
Use of Baseline Values to Establish E. coli Performance Criteria
Establishment of E. coli Performance Criteria to Verify Process
Control
Sampling Frequency for E. coli Testing
Sampling and Analytical Methodology
Recordkeeping
Use of E. coli Test Results by Establishments
Use of E. coli Test Results by FSIS
Implementation Timetable
Request for Comments
Pathogen Reduction Performance Standards
Rationale for Selecting Salmonella
Basis for Performance Standards and Plans for Future Adjustments
Determining Compliance with the Standard
FSIS Testing Strategy
FSIS Testing Methods
FSIS Enforcement Strategy
Implementation Timetable for Pathogen Reduction Performance
Standards
Response to Comments
The Indicator Organism
Frequency and Cost of Testing
Legal Authority for Testing Requirement
Performance Standards for Process Control
Basis for Target Levels
Methodology for Meeting Targets
Sample Size
Testing Methodology
Role of Inspectors
Laboratories
Alternative Sampling under HACCP
Relationship to HACCP
V. Other Issues and Initiatives
Antimicrobial Treatments
Cooling and Chilling Requirements for Raw Meat and Poultry
International Trade
Recordkeeping and Record Retention
Finished Product Standards for Poultry Carcasses
VI. Economic Impact Analysis and Executive Orders
Executive Order 12866
HACCP-based Regulatory Program Produces Net Benefit to Society
Market Failure Justifies Regulation of Pathogens
Regulatory Alternatives
Unfunded Mandates Reform Act
Regulatory Flexibility Act
Executive Order 12778
Paperwork Requirements
Sanitation Standard Operating Procedures (Sanitation SOP's)
Time and Temperature
Microbiological Testing
HACCP
VII. Final Rules
VIII. Appendix A--Guidelines for Developing a Standard Operating
Procedure for Sanitation (Sanitation SOP's) in Federally Inspected
Meat and Poultry Establishments
IX. Appendix B--Model of a Standard Operating Procedure for
Sanitation
X. Appendix C--Guidebook for the Preparation of HACCP Plans
XI. Appendix D--Hazards and Preventive Measures Guide
XII. Appendix E--FSIS Sample Collection Guidelines and Procedure for
Isolation and Identification of Salmonella from Raw Meat and Poultry
Products
XIII. Appendix F--Guidelines for Escherichia coli Testing for
Process Control Verification in Cattle and Swine Slaughter
Establishments
XIV. Appendix G--Guidelines for Escherichia coli Testing for Process
Control Verification in Poultry Slaughter Establishments
XV. Supplement--Final Regulatory Impact Assessment
I. Background
Overview of FSIS Food Safety Goal and Strategy
The mission of the FSIS is to ensure that meat, poultry, and egg
products are safe, wholesome, and properly marked, labeled, and
packaged. Regarding meat and poultry, FSIS currently carries out its
food safety responsibility primarily by managing an inspection program
within meat and poultry slaughter and processing establishments. This
program relies heavily on FSIS inspectors to detect and correct
establishment sanitation and food safety problems.
Recent outbreaks of foodborne illness and studies conducted over
the past decade by the National Academy of Sciences (NAS), the U.S.
General Accounting Office (GAO), and FSIS itself have established the
need for fundamental change in the FSIS meat and poultry inspection
program to improve food safety, reduce the risk of foodborne illness in
the United States, and make better use of the Agency's resources.
FSIS has embarked on a broad effort to bring about the necessary
changes in its program. In the preamble to the ``Pathogen Reduction;
Hazard Analysis Critical Control Point (HACCP) Systems'' proposed rule,
published in the Federal Register of February 3, 1995 (Docket #93-016P,
60 FR 6774; hereafter ``Pathogen Reduction/HACCP proposal''), FSIS
traced the origins of its current program, described today's food
safety challenges, and outlined a new food safety strategy for meat and
poultry products. In that document, FSIS proposed new regulations to
mandate adoption within meat and poultry establishments of HACCP, a
science-based process control system for food safety.
The HACCP requirement and other food safety measures proposed by
FSIS in the Pathogen Reduction/HACCP proposal were motivated by the
critical need to fill a gap in the current regulation and inspection
system and the lack of adequate measures to address the problem of
pathogenic microorganisms on raw meat and poultry products.
Such bacteria, including Salmonella, E. coli O157:H7, Campylobacter
and Listeria monocytogenes, are significant food safety hazards
associated with meat and poultry products. FSIS estimates that the
contamination of meat and poultry products with these bacteria results
annually in as many as 4,000 deaths and 5,000,000 illnesses.
FSIS stated the goal of its food safety strategy and proposed
Pathogen Reduction/HACCP regulations as follows: FSIS believes its
food safety goal should be to reduce the risk of foodborne illness
associated with the consumption of meat and poultry products to the
maximum extent possible by ensuring that appropriate and feasible
measures are taken at each step in the food production process where
hazards can enter and where procedures and technologies exist or can
be developed to prevent the hazard or reduce the likelihood it will
occur (60 FR 6785).
In establishing this goal, FSIS recognized that no single
technological or procedural solution exists for the problem of
foodborne illness and that the Agency's food safety goal would be
achieved only through continuous efforts to improve hazard
identification and prevention.
The food safety strategy FSIS outlined in the Pathogen Reduction/
HACCP proposal included the following major elements: (1) provisions
for systematic prevention of biological, chemical, and physical hazards
through adoption by meat and poultry establishments of science-based
process control systems;
[[Page 38808]]
(2) targeted efforts to control and reduce harmful bacteria on raw meat
and poultry products; (3) adoption of food safety performance standards
that provide incentives for innovation to improve food safety and to
provide a measure of accountability for achieving acceptable food
safety results; (4) removal of unnecessary regulatory obstacles to
innovation; and (5) efforts to address hazards that arise throughout
the food safety continuum from farm to table.
FSIS also stressed, as a central theme of its strategy, a need to
clarify and strengthen the responsibilities of establishments for
maintaining effective sanitation, following sound food safety
procedures, and achieving acceptable food safety results.
FSIS Regulatory Proposals
FSIS proposed HACCP as the organizing structure for its food safety
program because HACCP is the optimal framework for building science-
based process control to prevent food safety hazards into food
production systems. HACCP also focuses FSIS inspection on the most
significant hazards and controls.
To complement HACCP, FSIS proposed to establish, for the first
time, food safety performance standards for pathogenic microorganisms
on raw meat and poultry products, initially as ``interim'' targets for
the reduction of Salmonella contamination of raw carcasses and raw
ground meat and poultry products. These performance standards would
measure whether HACCP systems are working effectively to address food
safety hazards. FSIS proposed to require that establishments conduct
daily microbial testing for Salmonella to verify achievement of the
``targets.''
FSIS also proposed three near-term measures to speed progress on
controlling and reducing pathogenic microorganisms on raw products
during the proposed three year phase-in of HACCP. These proposed
measures were: (1) a requirement that all establishments adopt and
implement sanitation standard operating procedures (Sanitation SOP's);
(2) a requirement that all slaughter establishments use at least one
effective antimicrobial treatment to reduce harmful bacteria; and, (3)
standards for cooling red meat carcasses to prevent the growth of
harmful bacteria.
FSIS Regulatory and Inspection Reform Plans
In the Pathogen Reduction/HACCP proposal, FSIS acknowledged that it
must do more than mandate HACCP and other new regulatory requirements
in order to achieve its food safety goals. FSIS must also reform its
existing regulations, policies, and directives to be consistent with
HACCP principles and with the Agency's intention to rely more heavily
on performance standards. Current FSIS regulatory requirements and
procedures are generally highly detailed and prescriptive. They
specify, for example, precise cooking time-and-temperature combinations
for many products. Current regulations often assign to FSIS
responsibility for the means used by establishments to produce safe
food in a sanitary environment (e.g., FSIS requires that facility
blueprints and equipment receive Agency approval before use).
As part of its regulatory reform initiative, FSIS has undertaken
the conversion of current command-and-control regulations to
performance standards. Command-and-control regulations, and the
Inspection System Guide that FSIS inspectors use to enforce those
regulations, resulted from the perceived need to achieve uniformity
among federally inspected meat and poultry establishments.
Technological advances introduce a new imperative, however. If
establishments are to innovate, using new technologies to improve food
safety, they cannot be impeded by a one-size-fits-all regulatory
system. Under contemporary conditions, affording establishments the
flexibility to make establishment-specific decisions outweighs the
advantages of uniformly applicable rules. Recognizing this, FSIS is
changing inspection to meet the needs of the new regulatory system.
Under the command-and-control-based system, the inspector assumed
responsibility for ``approving'' production-associated decisions. Under
the new system, industry assumes full responsibility for production
decisions and execution. FSIS, having set food safety standards,
monitors establishments' compliance with those standards and related
requirements and under HACCP, verifies process control and pathogen
reduction and control. The number of inspection tasks will be reduced,
so that inspectors can focus more attention on areas of greatest risk
in the meat or poultry production system within each establishment.
With the shift to HACCP and greater reliance on performance
standards, establishments will be afforded greater autonomy in
decision-making affecting their own operations and, in return, be
expected to take responsibility for setting up site- and product
appropriate process control measures to achieve FSIS-established
performance standards. This approach, which is intended to increase
both the incentives and the flexibility establishments need to innovate
and improve food safety, requires a complete review and overhaul of the
``command-and-control'' requirements and procedures in current FSIS
regulations, policies, and directives.
HACCP-based food safety strategies and performance standards also
require important changes in FSIS's approach to inspection. FSIS
intends to clarify the respective responsibilities of FSIS inspectors
and establishment management.
In the Federal Register of December 29, 1995 (60 FR 67469), FSIS
published an advance notice of proposed rulemaking (ANPR) and
additional rulemaking proposals describing the Agency's strategy for
the regulatory and inspectional reform required to achieve the changes
required for consistency with HACCP. These changes will be accomplished
before establishments are required to implement HACCP.
Change Within FSIS
Finally, achieving the Agency's food safety goals will require
substantial change within FSIS itself, as the roles of establishments
and Federal inspectors are realigned to accord with the HACCP
philosophy. The scope of FSIS's food safety activities will also extend
beyond slaughter and processing establishments to include new
preventive approaches to hazards that occur during transportation,
distribution, and retail, restaurant or food service sale of meat and
poultry products.
This expansion of the Agency's roles will require substantial
training and redeployment of employees, and will place an enormous
strain on agency resources. To meet these challenges, FSIS has
conducted a top-to-bottom review of its regulatory roles, resource
allocation and organizational structure. Reports prepared by FSIS
employees containing analysis and recommendations on these topics were
described and made available for public comment in the Federal Register
of September 12, 1995 (60 FR 47346). FSIS will be making the
fundamental internal changes required to successfully carry out its
HACCP-based farm-to-table food safety strategy. These changes within
FSIS, which include a major reorganization of the Agency, will ensure
that FSIS is using its resources to improve food safety consistent with
its new regulatory framework.
[[Page 38809]]
The FSIS Pathogen Reduction/HACCP Rulemaking Process
Recognizing that HACCP and other regulatory requirements contained
in the Pathogen Reduction/HACCP proposal are part of a broad overhaul
of the FSIS regulatory program, and involve important changes in the
responsibilities of meat and poultry establishments, FSIS has conducted
a thorough and interactive rulemaking process. The Agency's goal has
been to provide many opportunities for submission by the public of both
written and oral comments and for interchange between FSIS and
interested parties on the many major policy and technical issues
involved in the reform of meat and poultry inspection.
The initial comment period was 120 days, which FSIS subsequently
extended for an additional 30 days and later reopened for another 95
days. During this period, FSIS held seven informational briefings,
three scientific and technical conferences, a two-day public hearing, a
scoping session and six issue-focused public meetings, a Federal-State
conference, and a Food Safety Forum. Extensive oral comments were
transcribed and included with written comments in the record of this
rulemaking. A brief summary of the various public meetings follows.
Seven Information Briefings
Initially, FSIS held informational briefings in seven cities across
the country to explain the Pathogen Reduction/HACCP proposal to the
public and to answer questions. A panel of FSIS officials and
scientists provided information on the proposed regulations and
answered questions. These briefings were not intended to solicit
comments, but to help interested parties prepare themselves to comment
on the Pathogen Reduction/HACCP proposal. These briefings were held:
March 7, 1995; Oakland, California
March 14, 1995; Dallas, Texas
March 16, 1995; Chicago, Illinois
March 21, 1995; Atlanta, Georgia
March 23, 1995; New York, New York
March 30, 1995; Washington, D.C.
May 22, 1995; Kansas City, Kansas
The Kansas City session included an informational briefing and
public meeting for owners and representatives of small meat and poultry
establishments and other affected small businesses to discuss the
Pathogen Reduction/HACCP proposal. At the meeting, many small business
owners said that the Pathogen Reduction/HACCP proposal might eventually
inhibit small businesses from competing with larger entities because
the resulting additional costs could be borne more easily by larger
companies. Three Directors of State Meat and Poultry Inspection
Programs stated their views that the Pathogen Reduction/HACCP proposal
might have a negative impact upon the small businesses for which they
provide inspection. Consumers requested that FSIS base its decisions on
the Pathogen Reduction/HACCP proposal not on industry impacts, but on
what will best protect the public.
Three Scientific and Technical Conferences
FSIS held three scientific and technical conferences to foster the
development of beneficial new food safety technologies, to fill gaps in
scientific knowledge, and to ensure that the Agency had the best
scientific information available for the rulemaking. Concerned that the
typical rulemaking process would not elicit this information, the
Agency invited experts on relevant subjects to the meetings, which were
open to all interested parties.
The first conference, titled ``New Technology to Improve Food
Safety,'' was held April 12-13, 1995, in Chicago, Illinois. This
conference explored the available technology that might be introduced
into the production and manufacturing of meat and poultry products to
control E. coli O157:H7 and other harmful pathogens in the food supply.
Participants included members of industry, academia, research
organizations, and consumers. Additionally, Government representatives
from non-food Federal regulatory agencies discussed technology
development and transfer in other industries. FSIS discussed how it
emphasized and encourages the approval and introduction of new
technologies.
The second conference, titled ``The Role of Microbiological Testing
in Verifying Food Safety,'' was held May 1-2, 1995, in Philadelphia,
Pennsylvania. This meeting explored scientific issues related to the
use of microbiological testing for verifying meat and poultry safety.
Six persons were invited to present discussions relating to the use and
limitations of microbiological testing in ensuring food safety. Twelve
representatives from academia, consumer groups, industry, and exporting
countries also presented talks on the concepts and methods for
microbiological testing that appeared in the proposed regulation.
During the comment period following the presentations, 15 people
commented on the subjects covered at the meeting and in the proposed
regulation.
The third conference, titled ``An Evaluation of the Role of
Microbiological Criteria in Establishing Food Safety Performance
Standards in Meat and Poultry Products,'' was held May 18-19, 1995, in
Washington, D.C. It explored the use of microbiological criteria to
establish food safety performance standards for meat and poultry
products. Participants generally agreed that HACCP is an effective
approach to controlling microbiological hazards in foods, and that
government and industry must work together to establish microbiological
criteria, sampling plans and training for food safety performance
standards. Most commenters agreed that the use of an indicator organism
is effective to facilitate and monitor the reduction of microbiological
contamination in meat and poultry products. Diverse opinions were
expressed on which indicator organisms should be chosen for each type
of product.
Public Hearing
On May 30 and 31, 1995, FSIS held a public hearing in Washington,
D.C., on the proposed rule.
Thirty-seven persons presented comments at the 2-day hearing.
Issues and viewpoints varied greatly. For instance, requests were made
to keep carcass-by-carcass inspection, but it was suggested that
organoleptic inspection is outdated. While there was support for a
HACCP system, many suggestions were made for changes in specific parts
of the proposal, particularly microbial testing and antimicrobial
treatments. Several commenters described their personal experiences
with foodborne illness. Small business owners and their representatives
commented on the potential financial burdens that might result from the
Pathogen Reduction/HACCP proposal.
Federal-State Relations Conference
As part of the annual meeting of Directors of State Meat and
Poultry Inspection Programs, FSIS held a ``Federal-State Relations
Conference,'' August 21-23, 1995, in Washington, D.C. This meeting, in
which the National Association of State Departments of Agriculture
participated, provided an opportunity for representatives from State
government to engage in an open exchange with senior USDA officials on
the Pathogen Reduction/HACCP proposal. In addition to State Directors,
the meeting included representatives from State Departments of
Agriculture, State Health Departments and local food safety enforcement
agencies; additionally, the Food and Drug Administration (FDA)
[[Page 38810]]
and the Association of Food and Drug Officials were participants. These
parties recognized a need to better protect the public by optimizing
the use of available resources. State agency representatives discussed
the need for better coordination within their own States and with the
Federal Government to prevent foodborne illness outbreaks. Improved
food handling education for industry and consumers was seen as one of
the primary ways to improve farm-to-table food safety.
Scoping Session and Six Issue-Focused Meetings
By late August, FSIS had received more than 6,800 comments on the
Federal Register notice, in addition to the input obtained at the
meetings and the hearing. All this information raised new issues and
modified Agency thinking in some areas. In order to share new
information and current thinking with its constituencies, FSIS held six
issue-focused public meetings on the proposed rule and accepted written
comments from those unable to attend. The meetings were announced in
the Federal Register (60 FR 45380; Thursday, August 31, 1995) and held
at USDA, Washington, D.C., on September 13, 14, 15, 27, 28, and 29,
1995.
FSIS framed an agenda for the meetings and provided issue papers
describing current Agency thinking on the proposed rule. Before the
issue-focused public meetings, FSIS held a public scoping session on
August 23, 1995, to ensure that all parties had an opportunity to
suggest issues for the agenda.
The issue papers provided at the six issue-focused public meetings
were published in the Federal Register (60 FR 54450; Tuesday, October
24, 1995).
Food Safety Forum
A Food Safety Forum chaired by Secretary Glickman was held on
November 8, 1995 to discuss food safety reform issues beyond the
specific issues raised by the proposed Pathogen Reduction/HACCP
proposal. The forum agenda included topics such as: (1) whether
legislative changes to the Federal Meat Inspection Act (FMIA) and the
Poultry Products Inspection Act (PPIA) were needed; (2) how FSIS could
improve food safety by organizational change, regulatory reform,
reliance on user fees, effective resource allocation and other means;
(3) cooperation between USDA and State inspection programs; and (4)
government and private sector roles in consumer education regarding
safe food handling practices. A transcript of the forum has been
included in the record for this rulemaking.
Farm-to-Table Strategy
In the preamble to its Pathogen Reduction/HACCP proposal, FSIS
presented a strategy for the control of food safety hazards throughout
the continuum of animal production and slaughter, and the processing,
distribution, and sale of meat and poultry products. FSIS has
historically focused on the manufacturing of meat and poultry products
through its inspection program, but the Agency's public health mandate
requires that the Agency also consider pre- and post-processing hazards
as part of a comprehensive strategy to prevent foodborne illness.
This farm-to-table food safety strategy is founded on three
principles:
Hazards that could result in foodborne illness arise at
each stage in the farm-to-table continuum: animal production and
slaughter, and the processing, transportation, storage and retail,
restaurant or food service sale of meat and poultry products. Each
stage presents hazards of pathogen and other contamination and each
provides opportunities for minimizing the effect of those hazards.
Those in control of each segment of the farm-to-table
continuum bear responsibility for identifying and preventing or
reducing food safety hazards that are under their operational control.
The Agency's public health mandate requires that it
address foodborne illness hazards within each segment of the food
production chain and implement or encourage preventative strategies
that improve the whole system.
FSIS remains committed to a farm-to-table food safety strategy
based on these principles. To address hazards arising within slaughter
and processing establishments, FSIS proposed and is adopting in this
rule significant new regulatory measures. Improving food safety before
the animals reach slaughter establishments will require a different
approach. The preamble to the Pathogen Reduction/HACCP proposal stated
that FSIS will be cooperating with animal producers, scientists in
academia, the Animal and Plant Health Inspection Service and other
government agencies to develop and foster food safety measures that can
be taken on the farm and through marketing channels to decrease public
health hazards in animals presented for slaughter. Within this context,
the voluntary application of food safety assurance programs based on
HACCP principles can be useful in establishing risk reduction practices
on the farm and through intermediate marketing stages to control and
reduce pathogen hazards at slaughter.
FSIS expects, within the limits of available resources, to serve as
a facilitator and coordinator of research and other activities designed
to encourage development and implementation of animal production
technologies and practices that can improve food safety. FSIS also
intends to offer its expertise to assist State health and agricultural
officials, when requested, during outbreak investigations of foodborne
illnesses to learn more about potential risk factors. FSIS does not
intend nor is FSIS authorized, to mandate production practices on the
farm, but does expect that continued public concern about foodborne
pathogens and adoption of HACCP and food safety performance standards
within slaughter and processing establishments will increase incentives
for improving food safety practices at the animal production level.
The post-processing transportation, storage, and retail, restaurant
or food service sectors are also important links in the chain of
responsibility for food safety. In these areas, FDA and State and local
governments share authority and responsibility for oversight of meat
and poultry products outside of official establishments. FSIS and FDA
are collaborating in the development of standards governing the safety
of potentially hazardous foods, including meat and poultry, eggs, and
seafood, during transportation and storage, with particular emphasis on
proper cooling to minimize the growth of pathogenic microorganisms, and
on disclosure of prior cargoes in transport vehicles. This effort will
be discussed in a forthcoming advance notice of proposed rulemaking.
In the retail, restaurant and food service areas, FSIS and FDA are
working in concert with State and local food regulatory officials to
foster adoption of updated, uniform, science-based standards, including
mandates for HACCP process controls for high-risk processing and
packaging operations. State and local authorities have assumed primary
responsibility for food safety oversight of retail, restaurant and food
service operations, but FSIS and FDA, working through the Conference on
Food Protection and other collaborative mechanisms, provide expertise
and leadership to support local authorities and foster development of
sound food safety standards and practices nationwide. FSIS is
cooperating with FDA to update the Food Code, a set of model ordinances
recommended for adoption by the
[[Page 38811]]
States, to ensure meat and poultry safety is adequately addressed in
retail, restaurant and food service settings.
Even as progress is made in reducing contamination of food by
harmful bacteria and other safety hazards at the production, processing
and subsequent commercial stages of the farm-to-table continuum, it
will remain critically important that individual consumers follow safe
food handling practices. Proper storage, preparation, and cooking of
meat and poultry products are essential to achieving the goal of
reducing the risk of foodborne illness to the maximum extent possible.
FSIS intends to augment its food handler and consumer education efforts
by expanding its collaboration with the meat and poultry industry,
other government agencies, consumer and public interest groups,
educators, and the media to effectively develop and deliver food safety
education and information to the public.
The HACCP requirements and other regulations FSIS is adopting in
this final rule will ensure that inspected establishments are taking
appropriate measures to reduce hazards at critical stages where the
risk of initial contamination is greatest. The public health benefits
of these measures, however, are only a part of a comprehensive food
safety strategy that seeks to minimize hazards throughout the farm-to-
table continuum.
General Overview of the Comments and the Final Rule
HACCP and Performance Standards
The FSIS proposal to require adoption of HACCP in meat and poultry
establishments was widely endorsed by comments from large and small
businesses, the scientific and public health communities, consumers,
and public interest organizations. Commenters strongly supported the
concept that meat and poultry establishments should systematically
build science-based food safety measures into their production
processes following the seven HACCP principles developed by the
National Advisory Committee on Microbiological Criteria for Food
(NACMCF). Although many commenters requested clarification of how FSIS
intends to implement HACCP and conduct inspection under HACCP, the
principal critical comments concerned costs and the practicality of
using HACCP in very small establishments. FSIS is adopting the HACCP
requirements, based on the NACMCF principles, essentially as proposed.
From a food safety standpoint, the most important objective of this
rulemaking is to build into food production processes, and into the
system of FSIS regulation and oversight, effective measures to reduce
and control harmful bacteria on raw meat and poultry products. This
will not by itself solve the problem of foodborne illness associated
with meat and poultry products. Effective measures are needed
throughout the farm-to-table continuum, but this rulemaking will fill
the most critical gap in the current system of meat and poultry
inspection. While products sold in cooked or otherwise ready-to-eat
forms are currently subject to controls and regulatory standards
designed to eliminate harmful bacteria, products sold raw are not
currently subject, as a general matter, to any such controls or
standards.
FSIS has concluded that HACCP-based process control, combined with
appropriate food safety performance standards, is the most effective
means available for controlling and reducing harmful bacteria on raw
meat and poultry products. HACCP provides the framework for industry to
set up science-based process controls that establishments can validate
as effective for controlling and reducing harmful bacteria. Performance
standards tell establishments what degree of effectiveness their HACCP
plans will be expected to achieve and provide a necessary tool of
accountability for achieving acceptable food safety performance.
Science-based process control, as embodied in HACCP, and appropriate
performance standards are inextricably intertwined in the Agency's
regulatory strategy for improving food safety. Neither is sufficient by
itself, but, when combined, they are the basis upon which FSIS expects
significant reductions in the incidence and levels of harmful bacteria
on raw meat and poultry products and, in turn, significant reductions
in foodborne illness.
The proposed interim targets for pathogen reduction based on
Salmonella generated widely diverse comments. Commenters supported the
goal of pathogen reduction, and many recognized some role for microbial
testing and the need for a microbial reduction target or performance
standard. Some commenters argued that the proposed testing regimen (a
single sample per species per day) was inadequate for its purpose in
large establishments, while others argued it was too burdensome in
small establishments. Some commenters specifically supported the
proposed Salmonella reduction targets and the daily testing
requirements. Many, however, criticized the proposed testing
requirements and considered Salmonella testing less useful than generic
E. coli testing as an indicator of whether process controls in
slaughter establishments are effectively preventing fecal
contamination, the primary pathway for pathogen contamination. At the
scientific conference on the role of microbial testing held in
Philadelphia, broad support also was expressed for using generic E.
coli rather than Salmonella as a process control indicator.
Based on public comments, FSIS has modified its approach to
establishing microbial performance standards. FSIS believes that
testing for generic E. coli is the appropriate and necessary means by
which meat and poultry slaughter establishments must verify their
process controls. FSIS reviewed written comments received on the
original proposal and comments made at the scientific conferences and
public meetings, as well as available scientific data, and has decided
to require slaughter establishments to conduct testing for generic E.
coli to verify process controls. Establishments will be required to
test for E. coli at a frequency that takes into account their volume of
production. FSIS is seeking additional scientific and economic data
that may help to further improve the E. coli testing protocols.
FSIS is also establishing performance criteria based on national
microbiological baseline surveys. The criteria are not regulatory
standards but rather provide a benchmark for use by slaughter
establishments in evaluating E. coli test results. Test results that do
not meet the performance criteria will be an indication that the
slaughter establishment may not be maintaining adequate process control
for fecal contamination and associated bacteria. Such results will be
used in conjunction with other information to evaluate and make
appropriate adjustments to ensure adequate process control for fecal
contamination and associated bacteria.
FSIS is also establishing pathogen reduction performance standards
for Salmonella that will require all slaughter establishments to reduce
the incidence of Salmonella contamination of finished meat and poultry
carcasses below the national baseline prevalence as established by the
most recent FSIS national microbiological baseline data for each major
species. FSIS will conduct Salmonella testing in slaughter
establishments to detect whether they are meeting the pathogen
reduction performance standards, and will require corrective action or
take regulatory
[[Page 38812]]
action, as appropriate, to ensure establishments are meeting the
pathogen reduction standards.
Pathogen-specific performance standards for raw products are an
essential component of the FSIS food safety strategy because they
provide a direct measure of progress in controlling and reducing the
most significant hazards associated with raw meat and poultry products.
The Salmonella standards being established in this final rule, which
are based on the current national baseline prevalence of Salmonella
(expressed as a percentage of contaminated carcasses), are a first step
in what FSIS expects to be a broader reliance in the future on
pathogen-specific performance standards. FSIS plans to repeat its
baseline surveys and collect substantial additional data through other
means and, on that basis, adjust the Salmonella performance standards
and possibly set standards for additional pathogens, as appropriate.
Also, FSIS will continue to explore establishing pathogen-specific
performance standards based on the levels of contamination (i.e., the
number of organisms) on a carcass. Future FSIS efforts on such
performance standards will reflect the fact that achieving the food
safety goal of reducing foodborne illness to the maximum extent
possible will require continuous efforts and improvement over a
substantial period.
Sanitation SOP's, Antimicrobial Treatments, and Cooling Requirements
for Raw Meat and Poultry Products
Comments generally supported the objectives of the three near-term
measures for raw meat and poultry products proposed by FSIS, Sanitation
SOP's, antimicrobial treatments, and carcass cooling standards, and
most commenters agreed that Sanitation SOP's should be a required
element of any meat and poultry establishment's food safety program.
Many commenters objected, however, to FSIS mandated antimicrobial
treatments in slaughter establishments and carcass cooling standards
for red meat prior to the implementation of HACCP. Although most
comments generally agreed that antimicrobial treatments would play an
important role in many slaughter establishments' HACCP plans, and that
proper carcass cooling would be an essential part of any HACCP plan for
raw meat and poultry products, these commenters argued that mandating a
particular approach to antimicrobial treatments or carcass cooling
would be inconsistent with the HACCP concept that establishment
management is responsible for designing a system of controls
appropriate for each establishment. They also argued that mandating
antimicrobial treatments was unnecessary if establishments were
required to meet pathogen reduction performance standards. Similarly,
with respect to the proposed requirement that establishments cool red
meat carcasses following specific cooling rate standards prescribed by
FSIS, commenters argued that HACCP, reinforced by performance
standards, would ensure proper carcass cooling. Many commenters said
that the specific time-and-temperature requirements proposed by FSIS
were often not feasible, posed worker safety concerns, and would divert
effort and resources that could be used more productively in preparing
for implementation of HACCP.
Based on the comments, FSIS has reconsidered its approach to the
proposed near-term measures. FSIS believes that its regulatory program
and the food safety efforts of the meat and poultry industry should be
focused on making a transition to HACCP as rapidly and effectively as
possible and that FSIS should not mandate any near-term measures that
would not be expected to continue as mandatory elements of a HACCP-
based system.
FSIS has decided to adopt final rules that mandate Sanitation
SOP's. Good sanitation is a critical foundation for HACCP, and
Sanitation SOP's are an essential element of the FSIS effort to more
clearly define establishment and inspector responsibilities, and better
focus both the establishment management and FSIS on those elements of
daily sanitation that relate most directly to the risk of product
contamination. Near-term implementation of Sanitation SOP's will
facilitate the transition to HACCP.
FSIS has decided not to mandate antimicrobial treatments in
slaughter establishments. The Agency expects that antimicrobial
treatments will play an important role in the design of slaughter HACCP
plans as establishments institute controls that are effective in
reducing pathogens and meeting FSIS performance standards. As a general
matter, however, FSIS does not intend to mandate the specific controls
that establishments must adopt in their HACCP plans. In the case of
antimicrobial treatments, FSIS believes that improvement in food safety
would be better served by providing establishments the incentive and
flexibility to incorporate antimicrobial treatments in any manner they
judge most effective for their operations to meet FSIS-established
performance standards for reducing bacterial contamination.
With respect to carcass cooling, FSIS continues to believe that, in
a HACCP environment, appropriate performance standards are needed for
the cooling of carcasses and raw meat and poultry products to prevent
the growth of harmful bacteria. After consideration of the comments,
FSIS has concluded, however, that the specific time-and-temperature
combinations proposed by FSIS were too restrictive and that a
scientifically sound and effective strategy for preventing the growth
of pathogens through proper cooling must apply not only within, but
also beyond, FSIS-inspected establishments. Thus, instead of including
requirements for carcass cooling in this final rule, FSIS intends to
extend this rulemaking to consider alternative approaches to
performance standards for cooling within establishments. Concurrently,
FSIS also intends to develop rulemaking covering the adoption of
standards for cooling of raw products during transportation, storage,
and retail, restaurant or food service sale. FSIS anticipates adopting
performance standards designed to minimize the growth of harmful
bacteria on raw products that establishments will be required to meet
through their HACCP plans. FSIS will announce in a future issue of the
Federal Register a three-day public conference to gather further
scientific information and public comment on these subjects.
Timetable for Implementation
Federally Inspected Establishments
FSIS proposed an implementation timetable that would have phased in
the near-term measures and HACCP over a period of time beginning 90
days and ending three years after publication of the final rule.
Sanitation SOP's and the other near-term measures, as well as the
proposed microbial sampling by establishments for Salmonella, were to
begin 90 days after publication. Slaughter establishments were to be
held accountable for meeting the Salmonella targets two years after
publication.
FSIS proposed to phase in HACCP over a one to three-year period,
primarily on a process-by-process basis. For example, raw ground
products would be subject to the HACCP requirements one year after
publication of the final rule, while all slaughter establishments would
be required to start HACCP thirty months (2\1/2\ years) after
publication of the final rule. However, FSIS proposed that
establishments with annual sales of less than $2.5 million be given
three years to
[[Page 38813]]
comply with the HACCP requirement, regardless of the processes they
run.
Some commenters said the proposed implementation timetable was too
slow, considering the seriousness of the food safety issues involved
and the familiarity with HACCP that already exists among many in the
industry. Other commenters pointed out that many larger establishments
have already adopted HACCP. Some said the Pathogen Reduction/HACCP
proposal placed excessive burdens on smaller establishments, which were
said to be less prepared technically and financially to carry out
HACCP. Wide support was voiced for implementing HACCP as promptly as
practicable, taking into account the diversity of businesses involved
and the different levels of readiness for HACCP.
FSIS has considered these comments and has also re-evaluated the
proposed timetable for implementation of all requirements discussed
above in light of preparations FSIS will itself have to make to
implement HACCP, including the training of inspection and other agency
employees. FSIS believes it is important to bring the meat and poultry
supply under HACCP-based process control and to implement other
elements of its food safety strategy as rapidly as possible. It is also
important to have a timetable that is realistic for implementing this
fundamental transformation in how FSIS regulates meat and poultry
establishments. FSIS is modifying the timetable for implementation in a
way that achieves both goals.
The Sanitation SOP's requirements will take effect 6 months after
publication of these final rules, rather than 90 days as originally
proposed.
Establishments slaughtering livestock or poultry will be required
to begin process control verification testing for generic E. coli 6
months after publication of this final rule.
FSIS will begin holding slaughter establishments and establishments
producing raw ground products accountable for achieving Salmonella
pathogen reduction performance standards at the time they will be
required to implement HACCP under the phase-in schedule described
below, rather than the single, two-year delayed effective date
originally proposed. Beginning approximately three months after
publication of this final rule, FSIS will initiate its pre-enforcement
Salmonella testing program. This establishment-by-establishment
Salmonella prevalence survey will provide critical data on the
performance of establishments; it will inform establishments of their
performance, and guide FSIS enforcement testing and compliance
strategies after establishments are required to meet the Salmonella
performance standards.
In response to comments, FSIS is modifying the proposed timetable
for implementing HACCP from one based primarily on production process
in an establishment to one based on establishment size. Under this
approach, the pace at which most of the Nation's meat and poultry
supply comes under HACCP-based process control will be accelerated.
Most important, slaughter establishments that account for 75% of the
annual meat and poultry production in the United States will be
required to implement HACCP 18 months after publication of these final
rules, rather than 30 months after publication as originally proposed.
At the same time, very small establishments (those with fewer than 10
employees or with annual sales of less than $2.5 million, together
accounting for less than 2% of meat and poultry production) will be
provided an additional six months beyond the proposed three years to
implement HACCP.
Under this timetable, FSIS gains needed time to develop and
sequence inspector training and other preparatory activities. Also,
establishments that carry out multiple processes (such as the so-called
``combo'' establishments that both slaughter animals and grind raw
products) will be able to implement HACCP on a more coherent
establishment-wide basis, rather than on a process-by-process basis. A
detailed description of the implementation timetable and its rationale
is provided in section II of this preamble.
State-Inspected Establishments
Both the FMIA and PPIA direct Federal cooperation with States in
developing and administering intrastate inspection programs that
include mandatory antemortem and postmortem inspection, reinspection,
and sanitation requirements which are ``at least equal to'' Federal
requirements. Consequently, each State receiving matching Federal funds
for the administration of its intrastate meat and poultry inspection
program must implement Pathogen Reduction/HACCP programs that are at
least equal to provisions set forth in this final rule. FSIS will
coordinate closely with States that maintain federally supported meat
and poultry inspection programs to ensure that Pathogen Reduction/HACCP
is implemented in all intrastate establishments.
Foreign-Inspected Establishments
In order to export meat or poultry to the United States, foreign
countries must establish a system of inspection that is equivalent to
the system in this country. Determinations of equivalency made by U.S.
reviewers of foreign meat and poultry inspection systems are currently
based upon (1) the presence or lack of specific regulatory requirements
and (2) how those requirements are enforced. As Pathogen Reduction/
HACCP regulatory provisions are implemented in the U.S. domestic
market, foreign countries will concurrently be evaluated to ascertain
whether their inspection systems provide equivalent regulatory
provisions with adequate levels of enforcement.
Implementation Conferences
FSIS plans to convene a three-day HACCP implementation conference
in Washington, DC, about 60 days after publication of this final rule.
Similar sessions will follow in various cities around the country.
The purpose of the implementation conferences is to continue, and
build upon, the dialogue among interested parties that occurred during
the six days of public meetings FSIS conducted in September 1995 on the
proposed rule. FSIS anticipates that the following topics will be
discussed at the implementation conferences: (1) status of FSIS efforts
to develop generic model HACCP plans and conduct small establishment
HACCP demonstration projects; (2) the draft guidance materials
published as Appendices; (3) the revised HACCP implementation schedule
and certain technical aspects of the regulations being promulgated in
this final rule; (4) other implementation issues identified by the
public; (5) methods to achieve the goal of consistent training for FSIS
and industry employees; and (6) due process and enforcement issues.
In addition, FSIS plans to conduct two public conferences on
technical issues related to E. coli testing. The first conference is
planned to be held approximately 45 days into the 60-day comment period
following publication of this rule. The public conference will be led
by a panel of scientists from FSIS and other government agencies who
will listen to testimony and review comments received on these
technical issues and share their observations and opinions. FSIS will
consider their input as well as all comments received as the basis for
any necessary technical amendments which will be completed at least 30
days before the
[[Page 38814]]
implementation date. The second conference is tentatively planned for
approximately 9 months following publication of this rule. This
conference would be an opportunity for the industry and others to
discuss with FSIS new information based on about 3 months of testing
experience that may bear on these same issues and might allow for
further adjustments of protocols before FSIS inspectors are tasked,
about three months later, with comparing test results to the national
criteria as part of their inspection routine. FSIS will publish
further, more detailed notice of these conferences in future issues of
the Federal Register.
Request for Comments
These final rules have benefitted from substantial public comment
and the dialogue that took place during extensive public meetings with
interested groups and individuals. Following the close of the comment
period on November 13, 1995, several industry associations requested
that these regulations be issued as ``interim'' final rules with a 30-
day opportunity for further public comment prior to the rules becoming
final. FSIS is denying this request because the HACCP principles and
other major elements of these final regulations have already been the
subject of unusually extensive public comment and dialogue, and it is
important to proceed toward implementation of these new food safety
measures as promptly as possible.
FSIS seeks comments, however, on certain technical aspects of these
final regulations and on the guidelines (published here as Appendices)
that will play a role in implementation of sanitation SOP's, microbial
testing, and HACCP. FSIS requests comments no later than September 23,
1996 on (1) technical issues that are associated with E. coli testing;
(2) the E. coli performance criteria, and (3) the Sanitation SOP's
Guideline and Model Sanitation SOP's, published at Appendices A and B,
respectively.
Based on comments it receives, FSIS will make any necessary
revisions in the draft guidelines and technical aspects of the E. coli
testing regulation prior to the effective date of the affected
regulatory requirements.
With respect to the HACCP final regulations, FSIS requests comments
by November 22, 1996 on (1) the revised HACCP implementation timetable,
including any factual information that commenters believe would justify
any adjustments in the announced effective dates; (2) the Hazards and
Preventive Measures Guide (published at Appendix D) and (3) the
Guidebook for the Preparation of HACCP Plans (published at Appendix C).
II. Hazard Analysis and Critical Control Point Systems
Overview of Final Rule
This final rule requires that federally inspected establishments
implement HACCP systems to address hazards that are reasonably likely
to occur in their operations. The HACCP systems mandated by this final
rule focus on attributes affecting product safety, not those affecting
economic adulteration or quality. On the effective dates of this final
rule, FSIS will begin verifying HACCP system operations as part of its
inspection program. Establishments will be required to maintain a HACCP
plan covering every meat or poultry product produced for human food.
Processes for which HACCP plans must be developed include slaughter for
all species; raw ground meat or poultry products; raw product, not
ground (e.g., meat cuts or whole or cut-up birds); shelf-stable
nonheat-treated products (e.g., jerky); shelf-stable heat-treated
products (e.g., edible fats); thermally processed/commercially sterile
products (e.g., canned soup); fully cooked nonshelf-stable products
(e.g., canned hams that must be refrigerated); not fully cooked/heat-
treated products (e.g., char-marked beef patties); and nonshelf-stable
products with secondary inhibitors (e.g., fermented sausage). It should
be noted that the category of raw, not ground product can include
products with certain additional processing steps beyond carcass
dressing, such as cutting up whole carcasses or marinating meat or
poultry products.
History and Background of HACCP
HACCP is a conceptually simple system whereby meat and poultry
establishments can identify and evaluate the food safety hazards that
can affect the safety of their products, institute controls necessary
to prevent those hazards from occurring or keeping them within
acceptable limits, monitor the performance of controls, and maintain
records routinely. HACCP is the best system currently available for
maximizing the safety of the nation's food supply.
HACCP systems have been recommended for use in the food industry
for more than a quarter century. The HACCP concept has been promoted by
government and scientific groups and incorporated for many years in
FSIS's and FDA's regulations on canned foods. Committees of the NAS
have recommended that government agencies with responsibility for
controlling microbiological hazards in foods, including FSIS,
promulgate regulations requiring industry to utilize the HACCP system
for food protection purposes.
The NACMCF, which was established in accordance with a NAS
committee recommendation, endorsed the HACCP system as an effective and
rational approach to the assurance of food safety. In its March 20,
1992, publication ``Hazard Analysis and Critical Control Point
System,'' NACMCF advocated the standardization of the HACCP principles
and their application by industry and regulatory authorities, with each
food-producing establishment developing a HACCP system tailored to its
individual product, processing, and distribution conditions.
The U.S. General Accounting Office, in a series of reports between
1992 and 1994, endorsed HACCP as an effective, scientific, risk-based
system for protecting the public from foodborne illness. On December
18, 1995, the FDA published final rules requiring the adoption of HACCP
systems in seafood processing plants (60 FR 65096).
International and foreign government bodies have also advocated the
adoption of HACCP systems. The International Commission on
Microbiological Specifications for Foods (ICMSF), in its 1988 report,
``HACCP in Microbiological Safety and Quality,'' endorsed the use of
HACCP systems in food production, processing, and handling. In 1993,
the Food and Agriculture Organization/World Health Organization Codex
Alimentarius Commission adopted a HACCP document that now serves as a
guide for countries to incorporate HACCP principles into their food
industries. The seven HACCP principles adopted by the Codex
Alimentarius Commission are identical to those adopted by the NACMCF
and on which this final rule is based. HACCP principles have been
embodied in recent European Union regulatory directives and in food
protection programs conducted by the governments of Canada, New
Zealand, and Australia.
The Seven HACCP Principles
The seven HACCP principles recommended by NACMCF in 1992 provide
the framework for this final rule. While the seven principles are not
explicitly listed as such in the codified regulatory text, they are
embodied in the regulatory requirements for a hazard analysis in
Sec. 417.2(a); the elements of a HACCP plan in Sec. 417.2 (b) and (c);
the corrective action requirements in Sec. 417.3; the validation,
verification, and reassessment requirements in Sec. 417.4; and the
record review and maintenance
[[Page 38815]]
requirements in Sec. 417.5. The seven HACCP principles are discussed
below.
Principle No. 1: A hazard analysis of each process must be carried
out. The purpose of the analysis is to identify and list the food
safety hazards reasonably likely to occur in the production process for
a particular product and the preventive measures necessary to control
the hazards. A food safety hazard is any biological, chemical, or
physical property that may cause a food to be adulterated or otherwise
unsafe for human consumption. A listed hazard must be of such a nature
that its prevention, elimination, or reduction to acceptable levels is
essential to the production of a safe food.
Examples of questions to be considered in a hazard analysis
include: (1) What potential hazards may be present in the animals to be
slaughtered or the raw materials to be processed? (2) What are the
avenues that might lead to contamination of finished product with
pathogenic microorganisms, hazardous chemicals, or other potentially
hazardous contaminants? (3) What is the likelihood of such
contamination and what are the means for preventing it? (4) Does the
food contain any ingredient historically associated with a known
microbiological hazard? (5) Does the food permit survival or
multiplication of pathogens or toxin formation during processing? (6)
Does the process include a controllable processing step that destroys
pathogens? (7) Is it likely that the food will contain pathogens and
are they likely to increase during the times and conditions under which
the food is normally stored before being consumed? (8) What product
safety devices are used to enhance consumer safety (e.g., metal
detectors, filters, thermocouples)? (9) Does the method of packaging
affect the multiplication of pathogenic microorganisms and/or the
formation of toxins? (10) Is the product epidemiologically linked to a
foodborne disease?
Principle No. 2: The critical control points (CCP) of each process
must be identified. A CCP is a point, step, or procedure at which
control can be applied and a food safety hazard can be prevented,
eliminated, or reduced to an acceptable level. All hazards identified
during the hazard analysis must be addressed. The information developed
during the hazard analysis should enable the establishment to identify
which steps in their processes are CCP's.
Identification of CCP's for controlling microbial hazards
throughout the production process is particularly important because
these hazards are the primary cause of foodborne illness. The
establishment may find the CCP decision tree developed by the NACMCF
useful in the CCP identification process (see Figure 1). However, the
use of this technique in identifying CCP's is not required by this
final rule.
Principle No. 3: The critical limits for preventive measures
associated with each identified CCP must be established.
BILLING CODE 3410-DM-P
[[Page 38816]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.000
BILLING CODE 3410-DM-C
A critical limit is the maximum or minimum value to which a process
parameter must be controlled at a CCP to prevent, eliminate, or reduce
to an acceptable level the identified physical, biological, or chemical
food safety hazard. Critical limits are most often based on process
parameters such as temperature, time, physical dimensions, humidity,
moisture level, water activity, pH, titratable acidity, salt
concentration, available chlorine, viscosity, preservatives, or
survival of target pathogens. Critical limits should be based on
applicable FSIS regulations or guidelines, FDA tolerances and action
levels, scientific and technical literature, surveys, experimental
studies, or the recommendations of recognized experts in the industry,
academia, or trade associations.
Establishments are encouraged to establish critical limits more
stringent than those now required by FSIS regulations or suggested by
scientific data to ensure that regulatory requirements are routinely
met, even when minor deviations occur.
Principle No. 4: The monitoring requirements for CCP's must be
established. Monitoring is an integral part of HACCP and consists of
observations or measurements taken to assess whether a CCP is within
the established critical limit. Continuous monitoring is preferred, but
when it is not feasible, monitoring frequencies must be sufficient to
ensure that the CCP is under control.
Assignment of the responsibility for monitoring is an important
consideration for each CCP. Personnel assigned the monitoring
activities should be properly trained to accurately record all results,
including any deviations, so that immediate corrective actions may be
taken.
Principle No. 5: The HACCP plan must include corrective action to
be taken when monitoring indicates that there is a deviation from a
critical limit at a critical control point. Although the process of
developing a HACCP plan emphasizes organized and preventive thinking
about what is occurring as the meat or poultry product is being
manufactured, the existence of a HACCP plan does not guarantee that
problems will not arise. For this reason, the identification of a
planned set of activities to address deviations is an important part of
a HACCP plan. In such instances, corrective action plans must be in
place to determine the disposition of the potentially unsafe or
noncompliant product and to identify and correct the cause of the
deviation. The HACCP plan itself might require modification, perhaps in
the form of a new critical limit, or of an additional CCP.
[[Page 38817]]
Principle No. 6: Effective recordkeeping procedures that document
the entire HACCP system must be developed and maintained. A HACCP
system will not work unless consistent, reliable records are generated
during the operation of the plan, and those records are maintained and
available for review. One of the principal benefits of a HACCP process
control system to both industry and regulatory officials is the
availability of objective, relevant data.
Principle No. 7: HACCP systems must be systematically verified.
After initial validation that the HACCP system can work correctly and
effectively with respect to the hazards, the system must be verified
periodically. Periodic verification involves the use of methods,
procedures, or tests in addition to those used for monitoring, to
determine whether the HACCP system is in compliance with the HACCP plan
and/or whether the HACCP plan needs modification and revalidation to
achieve its food safety objective.
In the NACMCF explanation of the verification principle, which FSIS
is following, four processes are involved in the verification of the
establishment's HACCP system. The establishment is responsible for the
first three; FSIS is responsible for the fourth. The first is the
scientific and technical process, known as ``validation,'' for
determining that the CCP's and associated critical limits are adequate
and sufficient to control likely hazards. The second process is to
ensure, initially and on an ongoing basis, that the entire HACCP system
functions properly. The third consists of documented, periodic,
reassessment of the HACCP plan. The fourth process defines FSIS's
responsibility for certain actions (Government verification) to ensure
that the establishment's HACCP system is functioning adequately.
HACCP and the FSIS Food Safety Strategy
The food safety goal of FSIS's Pathogen Reduction/HACCP rulemaking
proposal is to reduce the risk of foodborne illness from meat and
poultry products to the maximum extent possible by ensuring that
appropriate and feasible preventive and corrective measures are taken
at each stage of the food production process where food safety hazards
occur. There is no single technological or regulatory solution to the
problem of foodborne illness. Continuous efforts are required by
industry and government to improve methods for identifying and
preventing hazards and to minimize the risk of illness.
FSIS proposed HACCP as the framework for carrying out its
comprehensive strategy to improve food safety. HACCP, combined with the
other measures required by this rulemaking, will substantially improve
the ability of meat and poultry establishments and FSIS to target and
systematically prevent and reduce food safety hazards and, working
together, to continuously improve food safety as science and technology
improve. These measures fill a critical gap in the current system with
respect to the control and reduction of harmful bacteria on raw meat
and poultry products and will, over time, significantly reduce the risk
of foodborne illness.
FSIS's meat and poultry inspection program currently addresses and
will continue to address many matters of importance to the safety and
quality of the food supply, including supervision of industry
compliance with sanitation standards, exclusion of diseased animals
from the food supply, examination of carcasses for other visible
defects that can affect safety and quality, and inspecting for economic
adulteration. These activities respond to some of the public's most
basic expectations regarding the safety and quality of the food supply
and reflect the standards and requirements established by Congress in
the laws FSIS administers. FSIS is strongly committed to the most
effective and efficient implementation of these statutory requirements.
This final rule initiates a fundamental change in the inspection
program to better meet FSIS's paramount obligation to protect the
public health. Specifically, it addresses in a substantive way the
public health problem of foodborne illness associated with the
consumption of meat and poultry products. It does so in large part by
better delineating and clarifying the respective roles of industry and
FSIS to ensure that meat and poultry products are produced in
accordance with sanitation and safety standards and are not adulterated
or misbranded within the meaning of the FMIA and PPIA. This rule makes
clear that the industry is responsible for producing and marketing
products that are safe, unadulterated, and properly labeled and
packaged. FSIS is responsible for inspecting products and facilities to
verify that the statutory requirements are being met and for taking
appropriate compliance and enforcement actions when the requirements
are not being met.
The line between the responsibilities of FSIS and those of the
industry has often been blurred. This is because of the prescriptive
nature of the current FSIS inspection program and the tendency for some
establishments to rely on FSIS inspectors to do what is necessary to
direct the correction of deficiencies and to ensure that outgoing
products are safe, and not adulterated or misbranded. Some
establishments operate on the assumption that if the inspector
identifies no problem, their meat or poultry products may be entered
into commerce. This is even more problematic because the current
inspection system is based primarily on organoleptic methods that
cannot detect the hazards of pathogenic microorganisms. The line has
also been blurred because of the excessive reliance of the FSIS
inspection program on the detection and correction of problems after
the fact, rather than assurance that problems will be prevented,
systematically by design, in the first place.
The changes FSIS will effect with this final rule will eliminate
this confusion and delineate clearly the respective responsibilities of
FSIS and industry. The changes constitute a fundamental shift in the
FSIS regulatory program, which FSIS is convinced will significantly
enhance the effectiveness of the program and substantially reduce the
risk of foodborne illness.
Preparing for HACCP Implementation
For the new FSIS food safety strategy, particularly HACCP, to be
successful, FSIS must reconsider its current reliance on prescriptive
command-and-control regulations and instead rely more on performance
standards. Not only do command-and-control regulations prescribe the
means by which establishments are to achieve a particular food safety
objective, but they are susceptible of being enforced in a manner that
leads to the inspector's substantial involvement in management
decisionmaking. Performance standards, on the other hand, prescribe the
objectives or levels of performance (such as pathogen reduction
standards for raw product) establishments must achieve, but afford
establishments flexibility in determining how to achieve those
performance objectives. The shift to performance standards and the
concomitant increase in flexibility for meat and poultry establishments
reflect FSIS's commitment to stimulating the innovative capacity of the
meat and poultry and allied industries to improve the safety of their
products.
Command-and-control regulations are generally incompatible with
HACCP and the FSIS food safety strategy, and conflict with the goal of
reducing the
[[Page 38818]]
risk of foodborne illness on a continuing basis. They deprive
establishments of the flexibility to innovate, one of the primary
advantages of HACCP, and undercut the clear delineation of food safety
responsibilities between industry and FSIS, on which the FSIS strategy
is based. Therefore, to prepare for HACCP implementation, FSIS is
conducting a thorough review of its current regulations and will, to
the maximum extent possible, convert its command-and-control
regulations to performance standards. (For a discussion of this
regulatory reform initiative, see advance notice of proposed rulemaking
published on December 29, 1995; Docket No. 95-008A; 60 FR 67469).
Inspection Under HACCP
HACCP-oriented food safety inspection changes FSIS's approach to
overseeing the safety of meat and poultry products. Under this new
approach, FSIS will rely less on after-the-fact detection of product
and process defects and more on verifying the effectiveness of
processes and process controls designed to ensure food safety. FSIS
will restructure its inspection tasks and rely on review techniques
aimed at systems designed for preventing problems that could lead to
the production of unsafe meat or poultry products. FSIS will carry out
various activities to ensure that industry HACCP systems meet the
requirements of this rule, and are functioning as designed.
Beginning on the effective date of the regulation for a particular
establishment, FSIS personnel will carry out a general review of an
establishment's HACCP plan to determine its conformance with the seven
HACCP principles. This evaluation will take place at the time of start-
up or initial implementation of the HACCP plan for new establishments.
Subsequently, special teams of FSIS personnel will work in conjunction
with assigned inspectors to conduct in-depth reviews, on a regular
basis, of the establishment's current HACCP plan to verify their
scientific validity and ongoing adequacy for preventing food safety
hazards. Further, at any time that the HACCP plan is revised or
amended, FSIS personnel assigned to the establishment will review the
plan to determine if it is in conformance with regulatory requirements.
FSIS will also carry out its verification activities by focusing on
an establishment's ongoing compliance with HACCP-related requirements.
Inspectors will be assigned to carry out the verification activities
under HACCP-oriented inspection in much the same way as they receive
their assignment schedules under the current system. A verification
activity might include reviewing all establishment monitoring records
for a process, reviewing establishment records for a production lot,
direct observation of CCP controls as conducted by establishment
employees, collecting samples for FSIS laboratory analysis, or
verifying establishment verification activities for a process.
As HACCP-based process control is established in meat and poultry
establishments, with its continuous monitoring by the establishment and
oversight by FSIS, opportunities to incorporate new technologies and
continuously improve food safety will be more readily identified. The
continuous monitoring and verification of production processes and
controls by the establishment and FSIS, which is an essential feature
of the HACCP system, will set the stage for further food safety
improvements.
Many commenters on the proposal expressed concern that the number
of inspectors would decline and the quality of Federal inspection would
diminish with HACCP implementation. FSIS expects HACCP to enhance the
effectiveness of its meat and poultry inspection, not diminish it.
Implementation of this final rule will clarify that the meat and
poultry industries and FSIS have separate responsibilities for safety
of the food supply. Industry will be required to establish process
control systems for all forms of meat and poultry slaughter and
processing and meet appropriate regulatory performance standards. By
vigorous inspectional oversight of HACCP and reliance on objective test
results and other observations to verify compliance with performance
standards, FSIS inspectors will be better able to ensure that products
leaving FSIS establishments are safe. Also, FSIS will be better able to
allocate its resources to areas of greatest risk. HACCP implementation
will move both industry and FSIS toward a more preventive approach to
ensuring the safety of meat and poultry.
A cross-section of consumer groups, FSIS employees, and meat and
poultry establishments stated that each livestock and bird carcass must
continue to be examined by trained, experienced FSIS inspectors and
veterinarians, even under a HACCP system. They stated that carcass-by-
carcass inspection is essential to identifying animals with diseases
that are transmissible to humans and other disease conditions causing
animals to be unacceptable for human food. About 2,000 commenters
maintained that HACCP is not, nor should it be, a substitute for
carcass-by-carcass inspection by Federal inspectors.
Carcass-by-carcass inspection is a legal requirement that binds
both FSIS and the industry. It also addresses nonsafety considerations
that are not addressed by HACCP. Therefore, HACCP cannot substitute for
carcass-by-carcass examination. However, in light of HACCP, which will
improve process control in slaughter establishments, FSIS plans to
examine current tasks related to carcass-by-carcass inspection and
determine what changes, if any, could improve the effectiveness of
inspection or result in a more productive use of resources.
Many commenters representing the meat and poultry industries argued
that proposed pathogen reduction and HACCP system requirements layer an
additional set of regulations and an additional program of inspection
onto the current meat and poultry inspection system. These commenters
recommended that FSIS review and revise or eliminate current
regulations, directives and other FSIS guidance prior to finalizing the
proposal as a means for ensuring they are compatible with pathogen
reduction and HACCP requirements. Commenters stated that this review
would not only mitigate inspection burdens imposed on industry by the
proposal, but would facilitate the smooth implementation of pathogen
reduction and HACCP requirements, as well.
FSIS agrees that regulations, directives, and guidelines should be
consistent with HACCP and is currently reviewing regulations,
directives, and other guidance materials governing meat and poultry
inspection. Those regulations, directives, and guidance documents that
are inconsistent or incompatible with HACCP principles and procedures
will be amended or revoked. This task will not only ensure consistency
throughout the regulations, directives, and other documents, but will
reduce duplication and help focus inspection on the most serious risks
to food safety.
Implementation Schedule
FSIS proposed to phase in implementation of HACCP during a 12 to
36-month period primarily on a process-by-process basis, except that
all ``small'' establishments (defined as establishments with annual
sales of less than $2.5 million) would be allowed the full 36 months to
implement their HACCP plans.
FSIS received numerous comments on the proposed implementation
schedule. Many commenters from meat and
[[Page 38819]]
poultry establishments said the proposed period for implementing HACCP
was too short. These commenters requested more time to develop HACCP
plans, train employees, and purchase or upgrade equipment. Many
commenters requested that small businesses be granted more time to
implement HACCP so they could amortize the costs of hazard analysis and
plan development, equipment purchases, personnel training and records
maintenance. A number of commenters suggested alternative timetables
for implementation, ranging from three to fifteen years.
Several consumer groups argued that the proposed implementation
schedule was too slow and would compromise public health because
serious outbreaks of foodborne illness would continue to occur while
establishments prepare for HACCP implementation. Some industry
commenters said they were ready to implement HACCP immediately and
expressed concern about whether and when the FSIS inspection force
would be prepared to oversee HACCP implementation.
Also, several commenters requested a tiered implementation based on
product risk. These commenters suggested that establishments which
produce high-risk products, such as slaughter establishments or ground
beef processors, be required to implement HACCP first and that
establishments which produce low-risk products, such as canning
establishments, be required to implement HACCP last.
Also, some commenters were concerned about the proposed phase-in
period based on different types of product categories and processes
because contaminated meat and poultry are known to come from a variety
of sources. Commenters said that requiring establishments to implement
HACCP at different times for different processes within an
establishment would confuse establishment employees, inspection
personnel and consumers. Consequently, these commenters suggested that
HACCP be implemented simultaneously by all establishments.
Other commenters disputed the definition of small business used in
the proposal. Recommendations for defining a small business included
using fewer-than-500-employees definition developed by the Small
Business Administration (SBA), using a definition reflecting volume of
product or number of animals slaughtered, or using a definition based
on the level of sales.
In response to concerns expressed by commenters, FSIS is modifying
the implementation schedule for HACCP. The revised implementation
schedule is based on the size of an establishment, that is, a business
entity producing meat or poultry products at a location. Each
establishment is required to implement HACCP simultaneously for all
processes, rather than on a process-by- process basis. Large
establishments (those having 500 or more employees) are required to
implement HACCP 18 months after publication of this final rule.
``Small'' establishments are required to implement HACCP 30 months
after publication. The definition of ``small'' establishment has been
changed to correspond with SBA's size standards for business entities,
and is now an establishment having 10 or more but fewer than 500
employees. A new category of ``very small'' establishments (those
having fewer than 10 employees or less than $2.5 million in annual
sales) will have 42 months to implement HACCP. All individuals employed
on a full-time, part-time, temporary, or other basis at a given
establishment must be counted as employees. This requirement
corresponds with the SBA definition of employee set forth in 13 CFR
121.404.
FSIS is committed to bringing the Nation's meat and poultry supply
under HACCP systems as rapidly as possible. Phasing in HACCP
implementation is essential due to the logistical effort required to
manage a fundamental change in work processes, roles, and
responsibilities for both establishments and FSIS. The revised
implementation schedule reflects the readiness of establishments of
varying sizes to implement HACCP, the time needed by industry to
develop HACCP plans and train employees, and the time needed by FSIS to
train its employees.
The principal advantages of the revised implementation schedule are
as follows:
1. Large slaughter establishments account for 75 percent of
slaughter production and thus, most of the Nation's meat and poultry
supply will come under HACCP-based process control one year earlier
than originally proposed. Because the greatest risk of contamination
with pathogenic microorganisms occurs during this initial stage of
production, FSIS considers this a significant improvement over the
original schedule in terms of expediting progress on improving the
safety of meat and poultry products. The revised implementation
schedule also ensures that approximately 45 percent of processed
products will be produced under a HACCP system within 18 months. In
comparison, only 25 percent of processed products would have been
produced under HACCP systems at the 18-month mark based on the proposed
implementation schedule.
2. By shifting initial implementation of HACCP from 12 months to 18
months after publication of the final rule, FSIS will have sufficient
time to manage the transition to sanitation SOP's in all
establishments, which will begin six months after publication of this
final rule, and to train FSIS employees to implement HACCP. FSIS does
not believe it could manage this transition and successfully implement
HACCP in 12 months.
3. Eighteen months will provide ample time for the large
establishments to comply. In fact, it is reasonable to assume that many
of these establishments may implement HACCP before the deadline.
4. Implementing HACCP on the basis of establishment size will be
simpler for both FSIS and establishments and much less disruptive for
establishments with multiple processes. Under the proposal, these
establishments would have faced multiple implementation dates (e.g.,
establishments that both slaughter cattle and grind beef).
5. The ``very small'' establishments will have an additional six
months to implement HACCP. This will enable FSIS to complete the
demonstration projects planned for ``small'' and ``very small''
establishments. The extra time will also ensure the availability of
``off-the-shelf'' HACCP training programs prepared by private or
industry-sponsored consultants. Other FSIS implementation aids, such as
model HACCP plans, audio, video, or computer training aids, and various
publications such as guidelines, notices and pamphlets will have
undergone extensive development as well.
Small Business Issues
FSIS recognizes that many smaller establishments lack the
familiarity with HACCP that exists already in many larger
establishments. Therefore, FSIS is planning an array of assistance
activities that will facilitate implementation of HACCP in ``small''
and ``very small'' establishments.
FSIS is developing 13 generic HACCP models for the major process
categories, which will be available in draft form for public comment,
and in final form, at least six months before HACCP implementation. The
generic models are being developed especially to assist ``small'' and
``very small'' establishments in preparing their HACCP plans. Because
each HACCP system is developed by an individual establishment for its
specific process and practices, the generic models will serve only as
illustrations, rather than as
[[Page 38820]]
prescriptive blueprints for a specific HACCP plan. They should,
however, remove much of the guesswork and reduce the costs associated
with developing HACCP plans.
FSIS will also conduct HACCP demonstration projects for ``small''
and ``very small'' establishments during the two-year period following
promulgation of this final rule. These projects will be conducted at
various sites to show how HACCP systems can work for various products
under actual operating conditions. Some of these demonstrations will
involve ``very small'' establishments and will address issues unique to
those establishments. For instance, how does a HACCP system function in
an establishment with only a single employee? Through these
demonstration projects, FSIS, State inspection authorities,
participating establishments, and the industry at large will gain added
understanding of the problems and techniques of HACCP implementation
and operation in ``small'' and ``very small'' establishments.
FSIS is making available to ``small'' and ``very small''
establishments various HACCP materials that should assist these
establishments in conducting their hazard analyses and developing their
HACCP plans. These guidance materials include a ``Guidebook for the
Preparation of HACCP Plans'' (Appendix C) and a ``Hazards and
Preventive Measures Guide'' (Appendix D). These materials should be
particularly useful to ``small'' and ``very small'' establishments that
may lack the expertise for conducting hazard analyses and designing
establishment-specific HACCP plans.
The ``Guidebook for the Preparation of HACCP Plans'' has been
designed to provide ``small'' and ``very small'' establishments with a
step-by-step approach for developing a HACCP plan and includes examples
and sample forms at each step. The Guidebook can be used alone or in
combination with the ``Hazards and Preventive Measures Guide.''
Because the development of an adequate HACCP plan depends on a good
hazard analysis, the ``Hazards and Preventive Measures Guide'' develops
HACCP Principle No. 1 in much greater detail than does the ``Guidebook
for the Preparation of HACCP Plans.'' The hazards guide identifies
potential biological, chemical, and physical hazards associated with a
variety of raw materials and common ingredients, as well as major
processes used in the meat and poultry industry. In addition, the
hazards guide contains examples of preventive measures for common
hazards and associated critical limits for those measures. Also
provided are examples to illustrate approaches to implementing the
remaining HACCP principles (e.g., monitoring, corrective actions,
records, and verification procedures) for various hazards and critical
control points.
FSIS invites comments and suggestions on how it may further ease
the transition of ``small'' and ``very small'' establishments to HACCP-
based operations.
Training Considerations
Many commenters, including consumer groups, FSIS employees, meat
and poultry establishments, and State governments, agreed that proper
training in HACCP procedures and plan development is vital for
successful HACCP implementation. A number of commenters suggested that
joint training sessions be held for FSIS and establishment employees to
ensure uniform understanding between inspection personnel and industry.
Others suggested that FSIS certify acceptable training sites and
courses of study for establishment employees to coincide with
government employee training. However, some commenters argued that FSIS
should not accredit training programs because to do so would limit the
development of training programs.
FSIS agrees that effective training of both FSIS and industry
employees is critical to HACCP's success. FSIS also agrees that
alternatives are needed to make training practical for various kinds of
establishments. With these objectives in mind, FSIS is cooperating with
the private sector to ensure that a wide variety of training options
are available to industry and FSIS employees. For instance, FSIS is
encouraging the International Meat and Poultry HACCP Alliance, national
and local trade associations, State and local officials, the State
agricultural extension services, and local colleges and universities to
help establishments incorporate HACCP into their operations. The
implementation conferences, discussed elsewhere in this preamble, will
address how to achieve the goal of consistent training for FSIS and
industry employees.
Other plans include offering HACCP briefings to industry at many
locations nationwide. Each session will be led by FSIS HACCP trainers,
will be held during the evening, be open to industry and other
interested persons, and include a question-and-answer period. FSIS
training sessions will be limited to FSIS and State employees because
of complex logistical and cost considerations.
USDA's National Agricultural Library has developed and maintains
the HACCP Training Programs and Resources Database. It is accessible
via the Internet at ``http://www.nalusda.gov/fnic/foodborne/
foodborn.htm'' or ``gopher://gopher.nalusda.gov/11/infocntr/fnic/
foodborne/haccp'' and provides listings of available training programs
(workshops, satellite conferences, etc.), resources (videotapes,
software, manuals, textbooks, etc.), and consultants (individuals and
companies). Other Internet servers with HACCP-related information are
operated by various firms, governments, organizations, and academic
institutions.
Several meat and poultry establishments also commented on funding
for HACCP training, suggesting that FSIS or State inspection programs
fund establishment employee HACCP training. FSIS is making every effort
to assist establishments in making the transition to HACCP. However,
each establishment will be responsible for training its employees.
Mandatory Versus Voluntary HACCP
Most commenters supported the FSIS proposal to make HACCP mandatory
in all meat and poultry establishments. However, some commenters
requested that HACCP be voluntary rather than mandatory to alleviate
economic burdens, especially on small businesses. Commenters further
suggested that, at such time as a voluntary HACCP program proved
successful, FSIS could mandate HACCP or, alternatively, market forces
and advancing technology could be relied on to ensure its broad
acceptance in all parts of the meat and poultry industry.
FSIS has determined that a mandatory HACCP program is the only
viable option that will effect adequate processing improvements in all
establishments throughout the meat and poultry industries. Mandatory
HACCP systems are supported by several prominent organizations,
including the International Meat and Poultry HACCP Alliance and the
American Meat Institute, which petitioned FSIS to initiate rulemaking
to mandate HACCP. HACCP is now and has been voluntary; some
establishments have it, most do not. The preamble to the proposed rule
explained FSIS's conclusion, affirmed by most commenters, that HACCP is
the optimal framework for targeting and reducing the many potential,
but largely preventable, hazards associated with meat and poultry
products. The risks of
[[Page 38821]]
foodborne illness associated with meat and poultry products will be
minimized to the greatest extent possible only if HACCP systems are
implemented in every establishment.
HACCP From Farm-to-Table
A large number of commenters requested that HACCP be required
throughout all phases of food production, from the farm to the
consumer. These commenters asserted that HACCP plans could be developed
by producers, slaughterers, processors, retailers, food service
operators, and restaurants to assess and mitigate food safety risks.
Furthermore, many commenters claimed that the majority of foodborne
illness cases can be attributed to mishandling at the consumer level
and FSIS should therefore strengthen consumer education as well as
require HACCP.
There is widespread agreement that ensuring food safety requires
taking steps throughout the farm-to-consumer continuum to prevent
hazards and reduce the risk of foodborne illness. FSIS is encouraging
the active development of food safety measures to minimize public
health hazards in animals presented for slaughter. A description of
these farm-to-table efforts is discussed earlier in this document.
Total Quality Control (TQC) Establishments and HACCP
One commenter requested that establishments currently operating
under the TQC provisions (9 CFR 318.4(c) and, 381.145(c)) be allowed to
continue to operate under modified hours. If this is not the case,
establishments currently under TQC will incur considerable overtime
costs. The commenter asked why, if HACCP represents an improvement over
TQC, the establishment operating under HACCP should require more
inspection coverage than one operating under current TQC provisions.
This final rule does not alter current policies and practices
regarding inspectional coverage and overtime charges in establishments
operating under FSIS-approved TQC systems. HACCP is a safety-oriented
system of process control that addresses food safety hazards
differently than any current FSIS inspection systems, including TQC.
Because TQC systems address considerations unrelated to safety,
inspection practices developed by FSIS in connection with TQC may or
may not be applicable to the implementation of HACCP.
Freedom of Information Act Concerns
Most commenters stated that HACCP records should not be available
to requestors through the Freedom of Information Act (FOIA). Some said
HACCP records should be used for verification only and should not be
included in government files. Others also suggested that access to
records by FSIS inspection personnel be restricted to records that are
necessary for HACCP compliance monitoring, such as hazard analyses,
HACCP plans, CCP monitoring records and corrective action
documentation. Other commenters wanted to prohibit FSIS personnel from
copying or removing any records from the establishment. Some commenters
requested that HACCP records be generally available to the public.
In the preamble to the proposed regulation, FSIS stated that, as a
preliminary matter, at least some elements of HACCP plans and
monitoring records could be classified as trade secrets or commercial
confidential information and may be protected from public disclosure
under exemptions provided by FOIA and USDA and FSIS regulations
promulgated pursuant to FOIA. FSIS specifically invited comment on the
issue of public disclosure of HACCP records and on whether FSIS has any
discretion about the releasability of HACCP records that it has in its
possession.
Recordkeeping is critical to the successful functioning of HACCP
systems in meat and poultry establishments. FSIS will have access to
HACCP records and any other records FSIS regulations require. While the
records required by this final rule are clearly within the
establishment's domain and ownership, FSIS will have access to them.
These records, and FSIS access to them, are necessary to effectuate a
mandatory system of preventive controls to achieve food safety.
FSIS will continue to make use of documentation to which it has
access when necessary to evaluate the operations of official
establishments. Inspection personnel will normally review the records
at establishments as part of routine HACCP oversight activities. When
inspection personnel suspect that an establishment's HACCP system is
not operating correctly, they will copy appropriate portions of
establishment records, as needed, for further evaluation and possible
enforcement action.
An establishment will not ordinarily be required to submit copies
of HACCP plans, verification documents, or day-to-day operating records
to FSIS. Consequently, FSIS will not normally possess establishment
records that may be of a proprietary nature and the issue of whether
they are releasable under FOIA should not arise.
Copies of establishment HACCP records may, however, be acquired by
inspection personnel to document enforcement actions or otherwise
assist FSIS in carrying out its responsibilities. The release by FSIS
of information about establishments and their operations is governed by
the FOIA. This statute requires Federal agencies to make available to
the public agency rules, opinions, orders, records, proceedings, and
information concerning agency organization and operations. FOIA
provides exemptions from public disclosure for various kinds of
information, including information concerning trade secrets and
confidential commercial or financial information, and information
compiled for law enforcement purposes, the release of which would be
prejudicial or harmful to law enforcement or to the privacy rights or
safety of individuals.
The FOIA disclosure exemption that is most likely to be relevant is
that covering trade secret and confidential, commercially valuable
information. FSIS's experience in meat and poultry inspection, its
experience with HACCP, and its understanding from the cost-benefit
modeling and other studies undertaken in the preparation of these
regulations is that HACCP plans will take each establishment some time
and money to develop, and will be considered by the establishment to be
confidential. It follows that some HACCP plans will include
confidential, commercially valuable information, meeting the definition
of ``trade secret.'' Plans that incorporate unique time-and-temperature
regimens to achieve product safety, or other parameters that are
processor-specific and that are the result of considerable research and
effort, will ordinarily meet this definition.
Moreover, a plan is valuable to the establishment that produces it
for no other reason than that it took work to write. The equity in such
a product is not readily given away to competitors. FSIS also knows
from its own experience that establishment configurations tend to be
unique to individual establishments, or at least have unique features.
While generic plans will have great utility in many circumstances, they
serve primarily as models for establishments to develop their own
plans. Establishments will still have to expend time and money to
tailor HACCP to their individual
[[Page 38822]]
circumstances. Thus, at least some HACCP plans or other records will
include information to which FSIS has access but which FSIS will not be
required to disclose publicly under FOIA.
It should be noted, in this regard, that FOIA is not a
confidentiality statute, but has as its primary purpose the assurance
of the public's right of access to Government information. Agencies
must grant requests that ``reasonably describe'' information sought in
agency files that is not exempt from mandatory disclosure. For this
reason, FSIS understands that it cannot make promises of
confidentiality that exceed the permissible boundaries established
under FOIA.
FSIS Enforcement Authority and Whistleblower Protection
A large number of commenters requested that FSIS endorse
enforcement tools contained in the proposed Family Food Protection Act
(H.R. 1423, S. 515), including strengthened authority to refuse or
withdraw inspection from official establishments, assessment by the
Secretary of civil penalties for violations of the inspection laws, and
protection of ``whistleblowers'' from harassment, discrimination,
prosecution, and liability. Within the meaning of the proposed
legislation, whistleblowers are employees or other persons who assist
or demonstrate an intent to assist USDA in achieving compliance with
the laws and regulations, refuse to violate or assist in violating the
law, or are involved in commencing or testifying in a legal proceeding
conducted by USDA.
FSIS has determined that, while additional legislative authority
would be helpful in certain areas, it is not needed to implement HACCP
and the other requirements established in this final rule.
As to whistleblower protection, many comments urged that these
regulations include such protection for employees of meat and poultry
slaughtering or processing establishments. Whistleblower protection is
designed to protect workers from being fired or otherwise discriminated
against for revealing wrongdoing by their employers. The wrongdoing in
this case would presumably involve the forced falsification of HACCP
records or other interference with proper operation of the HACCP
system.
One concern raised by these commenters and others about the
credibility of a HACCP system is that important records can be
falsified. It is alleged that, without whistleblower protection, it is
much less likely that FSIS will know about falsifications. It was also
suggested that there is a need to encourage and protect employees who
report food safety problems or other violations of the inspection laws.
While FSIS is confident that it can detect falsification in the
course of its routine reviews of establishment records, coupled with
in-plant observations, FSIS also expects that, as is now the case, it
will be alerted by establishment employees to possible wrongdoing even
in the absence of whistleblower protection. FSIS has relied on
information provided by employees of the regulated industries for many
years. From time to time, information is provided with an expectation
that the identity of the informant will be kept confidential. FSIS
provides this protection, to the extent possible. This policy has been
effective.
As a legal matter, FSIS is not empowered by the FMIA and PPIA to
build explicit whistleblower protection into the regulations. In
contrast to the explicit statutory whistleblower protection accorded
Government employees, the FMIA and PPIA do not provide for
whistleblower protection for industry employees of the kind suggested
by some commenters, and no such explicit protection is included in the
final rule.
FSIS believes, however, that certain features of the HACCP
regulations being adopted and the manner in which FSIS will inspect
meat and poultry establishments compensate for the lack of formal
whistleblower protection, for purposes of ensuring food safety. Most
importantly, each establishment will be required to document, through
records kept by establishment employees, that the critical limits
required to ensure food safety are being met and when a failure occurs,
proper corrective action is taken. The failure to document safety-
related failures and to take necessary corrective action violates HACCP
regulations and the establishment will be subject to appropriate
regulatory action. Moreover, the falsification of required HACCP
records is a serious violation of Federal criminal law and will be
investigated and pursued aggressively by FSIS.
Establishments that conscientiously implement HACCP will, in the
course of normal operations, support employee reports of HACCP
deviations or other potential hazardous processing conditions and take
immediate corrective action. HACCP systems in which employees with
HACCP responsibilities are prevented or deterred from carrying out
their responsibilities will be considered inadequate, and FSIS will
pursue appropriate enforcement action.
By virtue of the extensive presence of FSIS inspectors in meat and
poultry establishments and the daily access of FSIS inspectors to HACCP
records, FSIS will be able to verify whether problems are being
properly documented and addressed and will be able to observe potential
food safety problems that establishments have not found or are not
confronting in an appropriate manner. FSIS emphasizes that undetected
or uncorrected conditions which are likely to cause foodborne illness
or injury should be reported immediately to FSIS by any person with
knowledge of their existence.
Enforcement and Due Process
A significant number of commenters raised concerns about the level
of discretion inspection personnel will have in suspending
establishment operations due to alleged deficiencies in either the
design or the operation of a HACCP plan. Some urged FSIS to make clear
to inspection personnel that such extreme actions are to be reserved
only for situations in which continued operation of the establishment
presents an imminent public health risk. Others strongly argued that
operations should be suspended or inspection withdrawn when an
establishment fails to comply with any HACCP requirements.
Clarification was requested regarding the imposition of penalties and,
specifically, what circumstances would warrant suspension of operations
or withdrawal of inspection.
Generally, the nature of the enforcement action taken will vary,
depending on the seriousness of the alleged violation. Minor violations
of the HACCP requirements may be recorded by Agency personnel to
determine establishment compliance trends. Minor violations may also
result in intensified inspection to ensure that there is no pattern of
noncompliance and that there is no underlying food safety concern.
Conversely, serious, repeated, or flagrant violations will result
in immediate regulatory action, such as stopping production lines;
applying ``U.S. Rejected'' tags to involved equipment, lines, or
facilities; retention of product, and suspension or withdrawal of
inspection. Because of the importance of recordkeeping to the
functioning of HACCP systems and the production of foods that are safe
for human consumption, FSIS views recordkeeping as a serious matter
with potentially grave implications if records are not properly
maintained or are falsified.
[[Page 38823]]
Many commenters were troubled by what they perceived to be limited
procedural due process afforded to establishments when faced with the
suspension of inspection due to a finding that the HACCP plan is
inadequate. FSIS agrees that all findings of inadequacy should be sound
scientifically and legally, and that suspensions should not be invoked
in an arbitrary manner. The optimal system would provide an appropriate
level of protection to establishments without unnecessary delay,
especially where no factual dispute is likely.
Based on the comments received on this issue, FSIS has decided not
to finalize the proposed Rules of Practice at this time. FSIS is
interested in receiving comments and suggestions on enforcement,
alternative dispute resolution, and due process issues, and has
included these topics for discussion at the implementation conferences.
On the basis of the conference discussions, FSIS will complete any
required rulemaking covering these issues prior to the first
implementation date for HACCP.
The Final Rule
Reorganization of HACCP Regulatory Text
FSIS has reorganized the codified regulatory text proposed in the
Pathogen Reduction/HACCP proposal and reworded a number of the
provisions. These changes have been made in response to comments
received on the proposal, for the sake of greater clarity and ease of
use, and to conform with FSIS's planned reorganization and
consolidation of all its meat and poultry inspection regulations. In
general, the final HACCP regulations are more streamlined than the
proposed provisions, organized in a more logical form, and less
prescriptive than the proposed regulations. Also, as part of the FSIS
and FDA effort to adopt a common approach to food safety (described in
the January 1996 National Performance Review document ``Reinventing
Food Regulations''), FSIS has made changes to the proposed regulatory
text, where applicable, to be consistent with FDA's final rule on HACCP
systems for seafood (60 FR 65096; December 18, 1995).
To the extent possible, the HACCP requirements for both meat and
poultry products have been consolidated in a new part 417.
Requirements affecting grants or refusals of inspection have been
moved to a new Sec. 304.3 and a new Sec. 381.22.
FSIS received approximately 7,500 written and many oral comments on
the proposed rule from meat and poultry slaughter operations,
processors, retailers, trade and other associations, consumer
advocates, the scientific and public health community, Federal and
State government agencies and foreign governments, employees, and other
interested parties. While a majority of these commenters supported the
proposal to require adoption of HACCP by meat and poultry
establishments, they differed widely regarding plan development,
implementation, and related issues. Comments on the specific proposed
regulatory requirements and FSIS's responses, follow.
HACCP Systems as a Condition of Receiving Inspection
Proposed Sec. 326.7(a)(2) and Sec. 381.602(a)(2) would have
permitted the issuance of a grant of inspection concurrent with a new
establishment's development and validation of its HACCP plan. This
provision is confusing because it is unclear how an establishment can
develop and validate its HACCP plan ``concurrent'' with the granting of
inspection when the HACCP plan can only be validated on the basis of
commercial operations and the establishment can operate commercially
only under inspection. Therefore, it would be impossible for an
establishment to validate a HACCP plan prior to receiving a grant of
inspection, as proposed. A number of commenters noticed this difficulty
and requested that establishments be allowed a reasonable amount of
time under commercial production to validate their HACCP plans.
Commenters also disagreed with the proposed HACCP plan development
timetable for new establishments or establishments producing new
products or those conducting product test production runs. Some said
that new establishments and establishments producing new products or
conducting test runs subsequent to the applicable HACCP effective date
should have at least six months or up to two years to finalize HACCP
plans. Others said that all HACCP plans should be developed before
start-up with revisions allowed within a reasonable period.
FSIS is in basic agreement with these comments and is revising the
basic procedures for granting inspection to allow establishments time
to validate their HACCP plans. The provisions in Secs. 304.3(b) and
381.22(b) require that any new establishment conduct a hazard analysis
and develop a HACCP plan prior to being issued a conditional grant of
inspection. The establishment must validate its HACCP plan within 90
days after the conditional grant of inspection is issued. After FSIS
has determined that the establishment has validated its HACCP plan, a
permanent grant of inspection will be issued. An establishment already
receiving inspection may produce a new product for distribution only if
it has developed a HACCP plan applicable to the product and validates
the plan within 90 days after beginning production of the product.
FSIS is requiring that new facilities and products be covered by a
HACCP plan at the time commercial production begins. Establishment
management is expected to consider development of HACCP systems as part
of essential pre-production decisions for new operations.
Establishments are also expected to modify their HACCP plans as needed
based upon experience and reported results. FSIS has determined that no
start-up time is needed in these instances since the establishment will
not be experiencing any transition from an old system to a new
processing system.
FSIS is considering what further changes may be necessary in the
procedures for granting and inaugurating inspection at official
establishments to better accommodate HACCP-oriented inspection. FSIS
plans to publish a notice of proposed rulemaking on this matter in the
near future.
Definitions
Proposed Secs. 326.1 and 381.601 have been combined, streamlined,
and redesignated as Sec. 417.1. Thirteen proposed definitions were
determined to be commonly understood or unnecessary and have been
removed. Of the seven definitions remaining, the definitions for
``critical control point,'' ``critical limit,'' ``HACCP system,'' and
``responsible establishment official'' have been clarified. For
example, the definition of ``critical control point'' includes the
phrase ``as a result'' to indicate that the prevention, reduction, or
elimination of a food safety hazard occurs because of action taken at
the critical control point. The definition of ``responsible
establishment official'' has been expanded to include the individual
with overall authority or a higher level official of the establishment.
The revised definitions are consistent with those promulgated in
FDA's final rule on HACCP systems for seafood. For example, FSIS has
added a new definition to Sec. 417.1 for the term ``process-monitoring
instrument.'' This term is defined as ``an instrument or device used to
indicate conditions during processing at a critical control
[[Page 38824]]
point.'' FSIS determined that this definition would be helpful to
establishments developing HACCP plans.
Hazard Analysis and HACCP Plan
The proposal required each establishment to develop and implement a
HACCP plan which incorporated the seven HACCP principles. A hazard
analysis was to be conducted to identify biological, chemical and
physical hazards and a list of steps in the process where potentially
significant hazards could occur and the preventive measures to be taken
were to be identified.
Provisions relating to the hazard analysis and development of the
HACCP plan were proposed as Secs. 326.2 and 381.602, ``Development of
HACCP Plan,'' Secs. 326.3 and 381.603, ``HACCP Principles,'' and
Secs. 326.4 and 381.604, ``Implementation of the HACCP Plan.'' These
provisions have been modified and incorporated into Sec. 417.2.
Several commenters argued that in the event the hazard analysis
identified no significant hazards, the establishment should be exempt
from developing HACCP plans and operating under a HACCP system.
Commenters identified lard and meat flavoring manufacturers and canning
operations as examples of establishments that may identify no hazards.
To clarify the concept of potentially significant hazards, and to
be consistent with the FDA final rule on HACCP systems for seafood, the
final rule requires each establishment to conduct, or have conducted
for it, a hazard analysis to determine the food safety hazards
reasonably likely to occur in the production process. A food safety
hazard that is reasonably likely to occur is defined as one for which a
prudent establishment would establish controls because it historically
has occurred, or because there is a reasonable possibility that it will
occur in the particular type of product being processed, in the absence
of those controls.
FSIS agrees that if an establishment's hazard analysis reveals no
hazards, then no HACCP plan would be required. However, FSIS is
currently unaware of any meat or poultry production process that can be
deemed categorically to pose no likely hazards. With regard to the lard
and meat flavoring examples, FSIS believes that reasonably likely
biological and physical hazards requiring control measures exist in
establishments manufacturing these products and that, therefore, HACCP
plans are required.
FSIS agrees that the microbial hazards associated with canned meat
and poultry products are eliminated by complying with the regulations
in 9 CFR Secs. 318.300-311 and 381.300-311. These regulations are based
on HACCP concepts and provide for the analysis of thermal processing
systems and controls to exclude microbial hazards. Accordingly, the
final rule provides that HACCP plans for thermally processed/
commercially sterile products do not have to address the food safety
hazards associated with microbiological contamination if the product is
produced in accordance with the canning regulations. However, because
the current regulations exclusively address microbial hazards,
processors of canned meat, meat food and poultry products must develop
and implement HACCP plans to address chemical and physical hazards that
are reasonably likely to occur.
The current canning regulations contain numerous prescriptive
features, including extensive FSIS involvement in the decisionmaking
process, that are inconsistent with the philosophy underlying HACCP. In
the advance notice of proposed rulemaking ``FSIS Agenda for Change:
Regulatory Review'' (60 FR 67469; December 29, 1995), FSIS stated its
intention to convert the canning regulations to performance standards,
which are more consistent with HACCP. Until changes in the canning
regulations are finalized, canning establishments do not have to
address microbial hazards in their HACCP plans.
The provisions of proposed Sec. 326.3(a), (a)(1), and (a)(2), and
Sec. 381.603(a), (a)(1), and (a)(2) relating to process flow charting
and the identification of intended uses and consumers of the product
have been combined in the final rule into Sec. 417.2(a)(2).
Proposed Secs. 326.2(b) and 381.602(b) would have required that any
HACCP plan be developed with assistance of a HACCP-trained individual
employed by the establishment, that the individual's name and resume be
on file, and that the individual meet other prescriptive requirements.
These requirements have been removed in response to criticism expressed
in comments received and for reasons given below in the discussion of
Sec. 417.7. The new Sec. 417.2(a)(1) permits someone other than an
establishment employee to conduct the hazard analysis.
Proposed Secs. 326.3(a) and 381.603(a) would have required a hazard
analysis to identify any biological (including microbiological),
physical, or chemical hazards. In Sec. 417.2(a)(3), FSIS lists ten
areas that should be considered by an establishment when performing its
hazard analysis. These ten areas are: natural toxins; microbiological
contamination; chemical contamination; pesticides; drug residues;
zoonotic diseases; decomposition; parasites; unapproved use of direct
or indirect food or color additives; and physical hazards. This list of
possible hazards provides more complete guidance to establishments
conducting a hazard analysis; it responds to industry comments
criticizing as ``vague'' the proposed definition of hazard; and it is
also consistent with the list of hazards in FDA's final rule on HACCP
systems for seafood.
Proposed Secs. 326.2(a) and 381.602(a) would have required that
establishments develop, implement, and operate a HACCP plan for each
process conducted by the establishment, and provided a list of process
categories subject to this requirement. Section 417.2(b) provides that
each establishment develop and implement a HACCP plan covering each
product produced, whenever its hazard analysis reveals one or more food
safety hazards that are likely to occur. This requirement is
substantively the same as the proposal.
Section 417.2(b)(1) provides a revised list of process categories,
while Sec. 417.2(b)(2) states that a single HACCP plan may encompass
multiple products within a single processing category, if the hazards,
CCP's, and critical limits are essentially the same, and as long as any
plan features that are unique to a specific product be clearly set out
in the HACCP plan and observed in practice. For example, an
establishment's HACCP plan for the processing of cooked sausage might
cover bologna, knockwurst, and frankfurters that the establishment
produces.
Proposed Secs. 326.2(d) and 381.602(d) would have required that the
HACCP plan be developed in two stages, both to be completed six months
prior to the phase-in date of the applicable process category or upon
application for inspection or when a new process is ready for
implementation. FSIS has eliminated these requirements because they are
impractical.
Proposed Secs. 326.2(d)(1) and 381.602(d)(1) would have required
that every HACCP plan be in a format similar to the NACMCF and FSIS
generic models. FSIS agrees with those commenters who found this
proposed requirement to be unnecessary and too prescriptive, and has
not included this requirement in the final rule.
Proposed Secs. 326.3 and 381.603 set forth the seven HACCP
principles accompanied by the corresponding requirements establishments
must meet when developing HACCP plans. In response to comments that the
detailed
[[Page 38825]]
provisions were unnecessary, FSIS has set forth in Sec. 417.2(c) a
simplified list of requirements, based on the seven HACCP principles,
to be met by establishments when developing HACCP plans. The proposed
requirements remain, except for the following additions, unchanged.
Two subparagraphs have been added to new Sec. 417.2(c)(2),
clarifying the requirements for the identification of CCP's within a
HACCP plan. This new section requires that establishments list in their
HACCP plan the CCP's for each of the identified food safety hazards,
including, as appropriate: (1) CCP's designed to control food safety
hazards that could be introduced in the establishment, and, (2) CCP's
designed to control food safety hazards that may have been introduced
into the product before, during and after its entry into the
establishment. In response to comments objecting to the proposed
requirement for establishments to use a decision tree in identifying
CCP's (proposed Sec. 326.3(b) and 381.603(b)), this requirement has
been removed from the final rule.
Proposed Secs. 326.4 and 381.604 would have required that a
responsible establishment official, formerly defined as ``the
management official located on-site at the establishment who is
responsible for the establishment's compliance with this part,''
review, approve, and sign the HACCP plan. Section 417.2(d)(1) requires
that the HACCP plan be signed by the responsible establishment
official, defined as the individual with overall authority on-site or a
higher level official of the establishment, possibly off-site. Further,
in Sec. 417.2(d)(2), FSIS is correcting an oversight in the proposal by
requiring that the HACCP plan must be signed and dated upon initial
acceptance by the establishment and at any time the plan is modified.
The proposal required that the responsible establishment official sign
the plan upon completion of the hazard analysis and the development of
the HACCP plan. The HACCP plan must also be signed and dated at least
once each year after the required reassessment.
Finally, FSIS explicitly states its statutory authority to enforce
the HACCP regulations under Sec. 417.2(e), providing that if an
establishment fails to develop and implement a HACCP plan or to operate
in accordance with the requirements of this part, the products produced
by the establishment may be deemed adulterated.
Corrective Actions
Proposed Secs. 326.3(e) and 381.603(e) would have required that
each establishment develop corrective actions to be taken when there is
a deviation from an established critical limit. Under the proposed
provisions, if a deviation were found, the establishment would describe
the steps taken to identify and correct the deviation, determine how
noncompliant product would be handled, ensure that no safety hazards
exist after the corrective actions are taken, and define measures to
prevent recurrence. Further, this section required that the
establishment determine whether its HACCP plan required modification
and, if so, to modify the plan.
Many commenters stated that establishments should be empowered to
make decisions on product safety. Commenters generally maintained that
the establishment should have primary responsibility for setting the
CCP's and critical limits and for taking corrective action when there
is a deviation. Inspectors should verify the overall effectiveness of
the HACCP plans, including the corrective actions taken by
establishments. A number of commenters were concerned about the
possibility that FSIS might take action on a product if a critical
limit in the establishment's HACCP plan was not met, even if the
establishment were taking corrective action under the plan. Commenters
felt that this action by FSIS would be unwarranted. An additional
concern was that the potential for this type of problem would be
compounded if the establishment set a critical limit more restrictive
than necessary for food safety to meet quality standards, for example,
a higher cooking temperature than necessary to produce a pathogen-free
product.
The establishment must take corrective action for any deviation
from a set critical limit. FSIS will verify that the establishment has
taken appropriate corrective action as specified in their HACCP plan.
If an establishment fails to take corrective action as specified in its
HACCP plan, FSIS may find that the HACCP system is inadequate pursuant
to Sec. 417.6(c). FSIS agrees that establishments should be empowered
to make decisions regarding product disposition in accordance with
corrective actions specified in their HACCP plans. FSIS is requiring
(Secs. 417.2(c)(5) and 417.3) that establishments describe in their
HACCP plans the corrective actions that will be taken if a critical
limit is not met and assign responsibility for taking corrective
action. Corrective actions must ensure that no product that is
injurious to health or is otherwise adulterated as a result of the
deviation enters commerce, that the cause of the deviation is
identified and eliminated, that the CCP will be under control after the
corrective action is taken, and that measures to prevent recurrence are
established.
FSIS recognizes that preestablished corrective actions may not
cover every contingency and that unforeseen hazards or deviations may
occur. Thus, Sec. 417.3 of the regulations provides a series of steps
to be taken in such situations. These steps include segregating and
holding affected product and conducting a review to determine the
acceptability of the product for distribution, ensuring that any
adulterated product or product otherwise injurious to health does not
enter commerce, and reassessing HACCP plans to determine if any
modification is needed.
Validation, Verification, and Reassessment
Proposed Secs. 326.3(g) and 381.602(g) would have required that
establishments develop procedures for HACCP plan validation by an
adequately trained individual, and set forth the related requirements.
Proposed Secs. 326.4 and 381.604 further detailed the validation
requirements, stating that during the validation period, establishments
shall conduct repeated verifications of the plan, hold frequent
meetings with Program employees, and review records generated by the
HACCP system. Under the proposal, establishments were to modify their
HACCP plan following any ingredient change, product reformulation,
manufacturing process or procedure modification, equipment change, or
any other such change. Revalidation of an establishment's HACCP plan
would have been required whenever significant product, process,
deviations, or packaging changes required modification of the plan.
Many commenters expressed confusion about the meaning of the terms
``validation'' and ``verification'' as used in the proposed rule. The
question of who will be responsible for validating HACCP plans was
raised by a number of commenters. Some requested a clearer definition
of the term ``validation'' as well as clarification of who will approve
and verify a HACCP program. Particular concern was expressed about what
role local inspection personnel will have in the HACCP plan development
and approval process. Some said that FSIS should assume more
responsibility for approving HACCP plans through a prior approval
system; others argued that no formal acceptance or prior approval of
[[Page 38826]]
HACCP plans by FSIS should be required.
In the final rule, FSIS has clarified the concepts of
``validation'' and ``verification'' by delineating the responsibilities
of FSIS and establishments in separate codified sections. The initial
validation, ongoing verification, and reassessment procedures to be
followed by establishments are presented in Sec. 417.4 and FSIS's
verification procedures are presented in Sec. 417.8.
Because prior approval of HACCP plans by FSIS would be contrary to
redefined roles and responsibilities inherent in the HACCP philosophy,
FSIS will not approve or validate HACCP plans before an establishment
implements its HACCP system. Each establishment will be responsible for
developing its HACCP plan and ensuring its adequacy.
Commenters opposed to FSIS involvement in plan validation offered
two suggestions: (1) establishments could use an independent third
party, such as a processing authority or consultant with HACCP
expertise to validate HACCP plans or (2) HACCP-trained establishment
employees could validate plans.
FSIS concurs. Establishments will be required to have validated
plans and may use independent consultants, process authorities, or
establishment employees trained in accordance with Sec. 417.7 for plan
development and validation. FSIS is not prescribing that any particular
validation method be used.
Some establishments may choose to use the services of laboratories
or processing authorities to validate their CCP's, especially if there
are questions about the effectiveness of traditional controls, or if
they are considering use of controls which have not been previously
validated, such as cooking time/temperature combinations. However, many
establishments will choose to rely on CCP's that have been
scientifically validated and reported in the literature. In either
case, FSIS believes that requiring individual establishments to
validate their HACCP plan ensures that the CCP's and the overall HACCP
plan work as intended in the establishment to reduce or eliminate
hazards and prevent the production of unsafe food.
One industry member observed that his company defines validation as
documenting that a critical control point eliminates or effectively
addresses microbiological hazards.
FSIS agrees that validation includes documenting that critical
control points effectively address relevant hazards, including such
microbiological hazards as E. coli O157:H7, Salmonella, and
Campylobacter, but emphasizes that validation is more than just the
accumulation of microbiological data verifying each CCP. It involves
scientifically demonstrating that a HACCP system as designed is
effective in controlling the food safety hazards identified through the
hazard analysis.
One academic commenter advocated inoculation studies using
pathogens as the best way to assure that a HACCP plan will effectively
control microbiological hazards. Such studies would be conducted before
HACCP implementation and should be aimed at demonstrating that selected
CCP's are appropriately monitored to control specific pathogens. The
studies would be performed under controlled conditions in off-site
laboratories or pilot establishments. One advantage of this approach,
according to the commenter, would be to permit validation studies to be
conducted by trade associations and other industry groups on a
collective basis in a way that could benefit both large and small
establishments.
FSIS agrees that validation of CCP's is an important part of HACCP
plan validation, and that laboratory inoculation studies as suggested
by the commenter can make an important contribution in appropriate
cases. Inoculation studies can demonstrate the effectiveness of
particular controls in addressing particular hazards under experimental
conditions, and can produce data that can be relied upon by many
establishments to support plan validation. In no case, however, would a
laboratory inoculation study or any laboratory study be sufficient by
itself to validate a HACCP plan. An important element of validation is
the identification or development of data which show that the
establishment can apply the process or control to get the anticipated
effect under actual in-plant operational conditions. For some well-
established, widely used processes or technologies, in-plant validation
can be accomplished by combining existing scientific data from
laboratory studies, the scientific literature, or other sources, with
the results of commercial trials using recognized protocols. Where
processes are well-documented in the scientific literature, it is not
necessary to require inoculation studies or any other research effort
as part of the validation process. However, an establishment
introducing a new technology, applying standard technology in an
unusual way, or lacking experience with a technology, would have to
undertake more extensive scientific and in-plant validation of its
HACCP plan under commercial operating conditions.
Data assembled to validate a HACCP plan are usually of two types:
(1) theoretical principles, expert advice from processing authorities,
scientific data, or other information demonstrating that particular
process control measures can adequately address specified hazards, such
as studies establishing the temperatures necessary to kill organisms of
concern; and (2) in-plant observations, measurements, test results, or
other information demonstrating that the control measures, as written
into a HACCP plan, can be operated within a particular establishment to
achieve the intended food safety objective. This means that the data
used to validate a HACCP plan may be derived from various sources,
including the scientific literature, product testing results,
experimental research results, scientifically based regulatory
requirements, FSIS guidelines, computer-modeling programs, and data
developed by process authorities. The nature and quantity of
information required to validate a HACCP plan will vary depending on
factors such as the nature of the hazard and the control measures
chosen to address it.
FSIS believes that validation data for any HACCP plan must include
some practical data or information reflecting an establishment's actual
early experience in implementing the HACCP plan. This is because
validation must demonstrate not only that the HACCP plan is
theoretically sound, but also that this establishment can implement it
and make it work. For example, steam vacuuming has been scientifically
demonstrated to be effective in removing visible contamination and
associated bacteria from carcass surfaces. A slaughtering establishment
using the technology as a control measure at a CCP, however, would
still have to demonstrate its ability to use the technology effectively
at the CCP.
Establishment verification is intended to show that the HACCP
system is actually working effectively on a day-to-day basis.
Verification also includes repeatedly reviewing and evaluating the
various components of the system. Verification activities include
checking the adequacy of the critical limits; reviewing monitoring and
recordkeeping procedures (as distinguished from monitoring the CCP's),
and evaluating the adequacy of corrective actions.
One consumer group stated that FSIS should require that
establishments identify the specific microbiological hazards that their
HACCP plans are
[[Page 38827]]
designed to address, and validate and verify the plans using pathogen-
specific testing to ensure that establishments control these hazards.
FSIS agrees that establishments must identify the specific
microbiological hazards their HACCP plans are designed to address and
that the plan must be initially validated and continually verified as
effective in addressing those hazards. FSIS also agrees that pathogen-
specific testing can play an important role in both initial validation
and verification.
For example, in validating the adequacy of a beef slaughter HACCP
plan addressing the hazard posed by E. coli O157:H7, laboratory
inoculation studies involving pathogen-specific testing could be used
to validate the effectiveness of the specific control measures that an
establishment is considering for incorporation in its HACCP plan. As
discussed above, to complete the validation of the control measures for
E. coli O157:H7, the establishment would also be required to
demonstrate that the experimentally validated measures can be
successfully carried out under actual operating conditions, but, for E.
coli O157:H7 on going verification is unlikely to include in-plant
testing for the pathogen due to its relatively infrequent occurrence.
In-plant testing to verify a control measure may be appropriate
with other pathogens, however. For example, a poultry slaughter
establishments would be required to validate and verify the
effectiveness of its HACCP plan in addressing the hazards posed by
Salmonella and Camplylobactor. Depending on the nature of the control
measures the establishment selects, in-plant pathogen testing could be
a necessary and practical component of an on-going verification for
these pathogens as they are present in sufficient numbers to make in-
plant testing feasible and informative. FSIS intends to work closely
with industry at large and with specific establishments in particular
to ensure that HACCP plans are adequately validated and verified for
microbial pathogens of public health concern.
Verification of HACCP plans by establishments is designed to
demonstrate that the HACCP plan is accomplishing process control and
resulting in the production of safe food on a continuing basis.
Verification is distinct from ongoing establishment monitoring, which
is designed to provide a record showing that the written HACCP plan is
being followed. Establishment verification activities should provide
practical results specific to the operation of its HACCP plan, and can
include review of CCP-monitoring records; review of corrective action
records; calibration of process-monitoring instruments; collection of
either in-line or finished product samples for microbiological,
chemical, or physical analysis; and direct observations of monitoring
activities and corrective actions. Frequencies for conducting
verification activities will vary, depending on various factors, such
as the type of process and volume of products, the results of prior
verification activities, consistency of conformance with the HACCP
plan, how deviations are handled, and the results of any sampling
activities.
The record-verification could include determining whether the
critical limit for the CCP, as called for in the HACCP plan, matches
the critical limit indicated in the records. The verification could
also involve checking to assure that the critical limit as set in the
establishment's HACCP plan is adequate to prevent a hazard. For
example, this check might involve determining whether the random
variations inherent in any process are within the limits (temperature
ranges, physical contamination) set for the process, and that the
critical limit is never exceeded or, further, that the probability that
the critical limit might ever be exceeded is extremely low.
The visual observations and records verification could include, in
addition to seeing that the records are being properly maintained,
assuring that corrective actions have been taken whenever any
deviations have occurred and that, when taken, the corrective actions
were sufficient to solve the problem.
FSIS has made two minor changes from the proposed validation and
verification requirements. First, FSIS has removed the proposed
requirement that during validation an establishment hold frequent
meetings with Program employees. FSIS recognizes that frequent meetings
may not be necessary or appropriate. Also, Sec. 417.4(a)(2) provides
that the establishment's ongoing verification activities include direct
observation of monitoring activities and corrective actions, review of
records, and calibration of process-monitoring instruments. An
establishment calibrates its monitoring instruments to determine
whether they are functioning properly.
Reassessment
The proposed rule would have required that establishments
revalidate the HACCP plan whenever significant product, process,
deviations, or packaging changes required modification of the plan.
A consumer group stated that establishments should be required to
examine their plans on a regular basis, whenever any new equipment is
introduced, new employee training is implemented, or for any other
significant change in the processing environment. The commenter further
stated that revalidation should be required of establishments every
three years even if there has been no significant change in operations.
Most commenters generally agreed that the industry has the primary
responsibility to review and modify HACCP plans when necessary and that
the review and modification process should be flexible.
FSIS agrees that HACCP plans should be reexamined periodically and
that the review and modification process should be flexible. The final
rule requires that each establishment reassess the adequacy of its
HACCP plan at least annually, and whenever any changes occur that could
affect the hazard analysis or alter the HACCP plan (Sec. 417.4(a)(3)).
These changes may include, but are not limited to, changes in: raw
materials or source of raw materials; product formulation; slaughter or
processing methods or systems; production volume; personnel; packaging;
finished product distribution systems; or the intended use or consumers
of the finished product. The reassessment must be completed by an
individual trained in accordance with Sec. 417.7. Immediate
modification of the plan is required if the reassessment reveals that
the plan is no longer adequate to meet the requirements of part 417.
FSIS is also requiring that an establishment that does not have a HACCP
plan reassess its hazard analysis whenever a change occurs that could
reasonably affect whether a food safety hazard exists.
FSIS considers annual reassessment appropriate because, as
commenters have noted, HACCP plans are dynamic and evolving. HACCP
plans may be modified several times during the months after they are
first implemented. Further, repeating the entire validation process may
not be necessary to ensure that the HACCP system is functioning
correctly after modification.
The intent of this provision is to provide for periodic
modification of the HACCP plan to ensure that it is continuously
effective in controlling and preventing food safety hazards. This
intent is supported by comments received from various sectors of the
public. The commenters tended to see periodic review and modification
of HACCP plans as both desirable and
[[Page 38828]]
expected and that periodic review and modification would allow the
establishment to apply its experience to continually improve process
controls.
FSIS believes that ``reassessment'' encompasses the different types
of evaluation, from reanalyzing the verification procedures for an
updated CCP to repeating the validation procedures set forth in
Sec. 417.4, that may be necessary.
FSIS Verification
Verification of HACCP plans is also a regulatory responsibility.
FSIS will verify that HACCP plans comply with the requirements of Part
417 and have been validated by the establishment. Potential
verification activities by FSIS may include, but are not limited to,
sampling activities (targeted and non-targeted, marketplace, rapid
screening tests for chemical residues); hands-on verification
(organoleptic inspection, use of temperature or other monitoring
devices); and review of establishment monitoring records. The frequency
of FSIS verification activities will vary, depending on a number of
factors such as the establishment's past performance, risk inherent in
the processes or products, quantity of product, and likely uses.
A consumer group stated that as part of its verification
activities, FSIS should review all pathogen data generated by the
establishment to determine the adequacy of the establishment's
conclusions regarding pathogen control. FSIS plans to undertake
extensive and varied activities to verify that a HACCP plan is working
as intended, including review of data generated or relied on by the
establishment to validate its HACCP plan.
Proposed Secs. 326.7(b) and 381.607(b) set forth FSIS's
responsibilities with respect to verification activities. These
provisions have been slightly revised for clarity and are consolidated
in Sec. 417.8.
Records
Proposed Secs. 326.6(b) and 381.606(b) listed the types of records
every establishment would have been required to maintain regarding
their operations under HACCP. The list included the written HACCP plan,
hazard analysis, records associated with CCP monitoring, corrective
actions, verification procedures and results, product codes, identity,
and slaughter production lot, the dates of the records, and supporting
documentation for the various features of the HACCP plan. FSIS also
proposed to require a preshipment review of processing and production
records associated with the HACCP plan to ensure that the records were
complete, that all critical limits were met, and, if applicable, that
corrective actions were taken. The review was to be performed by
someone other than the person who created the records, preferably by a
HACCP-trained individual, or by the responsible establishment official.
FSIS considers the preshipment record review a routine verification
function under HACCP principle No. 7.
FSIS also proposed that establishments retain all required records
on site at all times, except those records concerning monitoring CCP's,
corrective actions, and verification procedures were to be retained at
the establishment for no less than one year, and for an additional two
years at the establishment or other location from which the records
could be made available to Program employees.
Regarding the preshipment review of records, several small
establishments commented that there may not be a person other than the
person who created the record available to conduct the preshipment
review. Several large establishments were concerned that a HACCP-
trained individual may not be available to conduct the preshipment
review. FSIS has modified this requirement by stating that the
preshipment review shall be conducted by someone other than the person
who produced the records where practicable. Also, FSIS has retained the
provision that the review be conducted preferably by an individual
trained in accordance with Sec. 417.7 or the responsible establishment
official.
Some commenters recommended that FSIS allow the use of electronic
or computerized recordkeeping systems to ease the burden of the
proposed recordkeeping requirements. In response to these comments,
FSIS has added a new Sec. 417.5(d) which provides for the maintenance
of data and information on computers, as long as controls are
implemented by the establishment to ensure the integrity of the data
and signatures.
Commenters also raised concerns regarding proposed record retention
requirements, maintaining that keeping HACCP records for a minimum of
three years would be excessive. Commenters requested flexibility in
deciding how long to retain records; many stated that retention should
be based on product shelf-life. In response to these commenters, FSIS
has modified this requirement to provide that records required by
Sec. 417.5(a)(3) be retained at the establishment for one year if they
pertain to slaughter activities or refrigerated products, and for two
years if they pertain to frozen, preserved, or shelf-stable products.
To further ease the recordkeeping provisions for establishments,
FSIS will permit the off-site storage of records required by
Sec. 417.5(a)(3) that are over 6 months old if the records can be made
available to Program employees within 24 hours of the request. The
records required by Sec. 417.5 (a)(1) and (a)(2), however, are not
eligible for off-site storage.
Proposed Secs. 326.6 and 381.606 would have provided that records
be made available to Program employees. Section 417.5(f) clarifies that
all records required by part 417 be available to Program employees for
review and copying.
For clarity, FSIS has reworded the recordkeeping provisions to
require that the establishment maintain the written hazard analysis and
all supporting documentation, the written HACCP and all decisionmaking
documents associated with the selection and development of CCP's and
critical limits, and documents supporting both the monitoring and
verification procedures selected and the frequency of those procedures.
Records documenting the monitoring of CCP's and critical limits,
corrective actions, verification procedures and results, product
code(s), product name or identity, or slaughter production lot must
also be maintained. Each record must include the date the record was
made. To be consistent with FDA's final rule on HACCP systems for
seafood, FSIS has also added a requirement that records relating to the
calibration of process-monitoring instruments be maintained.
Training
FSIS proposed two definitions related to training: ``HACCP-trained
individual'' and ``recognized HACCP course.'' ``HACCP-trained
individual'' was defined as ``a person who has successfully completed a
recognized HACCP course in the application of HACCP principles to meat
or poultry processing operations, and who is employed by the
establishment. A HACCP-trained individual must have sufficient
experience and training in the technical aspects of food processing and
the principles of HACCP to determine whether a specific HACCP plan is
appropriate to the process in question.'' A ``recognized HACCP course''
was defined as ``a HACCP course available to meat and poultry industry
employees which satisfies the following: consists of at least 3 days, 1
day devoted to understanding the seven principles of HACCP, 1 day
devoted to applying these concepts to this and other regulatory
requirements of FSIS, and 1 day devoted
[[Page 38829]]
to beginning development of a HACCP plan for a specific process.''
Some commenters thought that defining a HACCP-trained individual
was unnecessary, that the role of such a person in operating HACCP
systems should be analogous to the role of the processing authority in
canning operations.
A few commenters questioned the effectiveness of the proposed
three-day training requirement stating it would not sufficiently
qualify a person to implement or operate a HACCP system. Some
commenters asserted that the detailed course composition with no FSIS
certification of courses was inadequate and too rigid. Others insisted
that what is needed is a common understanding of the basic principles
of HACCP and of how HACCP can be applied to specific processes and
establishments, with no FSIS certification of courses.
FSIS has revised the regulations, which are now codified in
Sec. 417.7, to simplify the proposed training requirements. The
proposed definition and requirements for a HACCP-trained individual
have been removed. Section 417.7 requires that individuals performing
certain functions must have successfully completed a course in the
application of the seven HACCP principles to meat and poultry product
processing, including a segment on the development of a HACCP plan for
a specific product. Only those individuals who meet the training
requirements may perform the following functions:
Development of the HACCP plan as required by
Sec. 417.2(b);
Reassessment and modification of the HACCP plan as
required by Sec. 417.3 and/or Sec. 417.4(a)(3).
The rule has been modified to set a basic standard for HACCP
training while preserving the flexibility needed by industry to
implement HACCP systems effectively. The provisions of Sec. 417.7 are
consistent with FSIS's view that training is central to the success of
HACCP, that there are many avenues for HACCP training needs, and that
responsible establishment officials are in the best position to
determine the training needs for each establishment.
Adequacy of HACCP Plans
The proposed rule stated that a HACCP plan could be found invalid
if it does not meet the regulatory requirements, if HACCP records are
not being maintained to validate the plan or verify process control
under the plan, or if a processing failure results in production of
adulterated product.
The provisions of the final rule relating to the criteria for
finding a HACCP plan inadequate are essentially the same as in the
proposal, except that the term ``invalid'' has been replaced with
``inadequate'' for clarity. Also, the final rule states that a HACCP
plan may be found to be inadequate if establishment personnel are not
performing tasks specified in the HACCP plan. One change from the
proposal concerns the correction of HACCP systems found inadequate
because of product adulteration. Under the proposed
Secs. 326.7(c)(3)(ii) and 381.607(c)(3)(ii), the establishment would
have been required to submit to FSIS, among other things, a written
plan for chemical or microbiological testing by an external laboratory
of finished product produced under the modified HACCP plan to show that
the modified plan corrected the problem. The final rule is more
flexible because decisions regarding the appropriateness of the HACCP
system modifications are made by the establishment.
FSIS will verify that HACCP plans are adequate. The procedure for
determining the adequacy of the HACCP plan will not be a one-step
process. Instead, FSIS will take a variety of actions including
reviewing the HACCP plan and associated records, directly observing the
HACCP system in operation, and assessing the adequacy of corrective
actions. After a thorough review is conducted, FSIS will determine
whether a HACCP plan is adequate. If a plan is found to be inadequate,
FSIS will take appropriate regulatory action.
III. Sanitation Standard Operating Procedures
The Proposed Rule
FSIS proposed that all meat and poultry establishments be required
to develop, maintain, and adhere to written sanitation standard
operating procedures (Sanitation SOP's). The proposal was based on
FSIS's belief that effective establishment sanitation is essential for
food safety and to successful implementation of HACCP. Insanitary
facilities or equipment, poor food handling practices, improper
personal hygiene, and similar insanitary practices create an
environment conducive to contamination of products. There are direct
and substantial links between inadequate sanitation and the
contamination of meat and poultry products by pathogenic bacteria. FSIS
tentatively concluded that Sanitation SOP's were necessary because they
would clearly define each establishment's responsibility to
consistently follow effective sanitation procedures and would
substantially minimize the risk of direct product contamination and
adulteration.
FSIS also had determined that Sanitation SOP's would improve the
utilization of FSIS Inspection Program resources by refocusing FSIS
sanitation inspection on the oversight of establishment prevention and
correction of conditions that cause direct product contamination or
adulteration. After Sanitation SOP's were in place, Agency inspection
personnel would spend less time enforcing detailed sanitation
requirements and directing the correction of problems after they occur.
Instead, FSIS inspectors would focus on oversight of an establishment's
implementation of Sanitation SOP's and on taking appropriate regulatory
action when an establishment's Sanitation SOP's were not properly
executed or when product contamination or adulteration was imminent,
directly observed, or probably had occurred.
The concepts underlying the proposed requirements for Sanitation
SOP's are important and new. In the past, FSIS has not clearly
articulated the responsibility every establishment has to ensure that
sanitation requirements are met every day, both before and during
operations. Although the majority of meat and poultry establishments
maintain adequate sanitary conditions, some establishments have
significant sanitation problems that can be resolved only through more
clearly defining establishment responsibility and accountability for
the daily observance of sound sanitation practices.
The proposed requirements for Sanitation SOP's were the result of
many years of observations by FSIS of establishment sanitation and
management practices. The persistence of insanitary conditions within
some meat and poultry establishments was documented in the ``1,000
Plant Review,'' conducted by FSIS between September 1993 and February
1995. This project involved unannounced visits to 1,014 inspected
establishments during which operations were observed and deficiencies
noted. More than 60 percent of all deficiencies documented by the
review involved establishment sanitation. The distribution of
sanitation problems was not, however, uniform in the establishments
sampled. Fewer than half those establishments visited accounted for 90
percent of the sanitation deficiencies. Data collected through FSIS's
Performance Based Inspection System similarly documents that sanitation
is the most frequent deficiency noted by inspection personnel in
routine establishment visits.
[[Page 38830]]
Through analysis of this information, FSIS determined that the
difference between establishments with consistently sanitary conditions
and those with chronic sanitation deficiencies is often that the better
performing establishments have effective quality control and sanitation
programs, including written Sanitation SOP's, while the marginal
establishments do not. As a means of bringing all establishments to a
consistently acceptable level of sanitation, as well as to clarify the
respective roles of establishments and FSIS in achieving that goal in
each establishment, FSIS proposed that every meat and poultry
establishment develop, maintain, and adhere to written Sanitation
SOP's.
FSIS proposed that Sanitation SOP's cover the daily preoperational
and operational sanitation procedures that the establishment would
implement to prevent direct product contamination or adulteration.
Additionally, establishments would be required to identify the
establishment officials who would monitor daily sanitation activities,
evaluate whether the Sanitation SOP's are effective, and take
appropriate corrective action when needed. Also, each establishment
would be required to make daily records showing completion of the
procedures in the Sanitation SOP's, any deviations and corrective
actions taken, and maintain those records for a minimum of six months.
Further, an establishment's Sanitation SOP's and records were to be
made available to FSIS for verification and monitoring. Finally, the
proposal provided that any equipment, utensil, room or compartment
found by an inspection program official to be not in compliance with
the Sanitation SOP's or insanitary would be tagged ``U.S. Rejected,''
and could not be used until it had been reinspected and passed.
FSIS solicited comments on the proposed regulatory requirements for
Sanitation SOP's. FSIS also requested comments on how Sanitation SOP's
should clarify the responsibilities of establishments and what role
inspection personnel should play in authorizing daily startup of
operations. Comments also were requested on whether certain Good
Manufacturing Practices (GMP's) or other sanitation practices should be
mandatory elements of the Sanitation SOP's.
The majority of the comments addressing the proposed Sanitation
SOP's provisions expressed support. Many commenters, however, expressed
concern about the lack of detail in the proposal regarding the required
contents of an establishment's Sanitation SOP's and about how
Sanitation SOP's would be enforced by inspectors. The comments, both
written and oral, and FSIS's responses are discussed in the
``Comments'' section, which follows the description of the final rule.
The Final Rule
After careful consideration of the comments, FSIS is promulgating
requirements for Sanitation SOP's, essentially the same as proposed,
though with several changes and additions for both clarity and to grant
establishments greater flexibility in meeting the Sanitation SOP's
requirements.
As proposed, all inspected establishments shall develop, implement,
and maintain written Sanitation SOP's. The Sanitation SOP's shall
describe all procedures and establishment conducts daily to prevent
direct contamination or adulteration of product(s). FSIS has clarified
that Sanitation SOP's also shall specify the frequency with which each
procedure in the Sanitation SOP's is to be conducted and identify the
establishment employee(s) responsible for the implementation and
maintenance of such procedure(s). While the employee responsible for
implementation and maintenance of procedures in the Sanitation SOP's
may be the employee who actually performs such activities, he or she
instead may be the employee in charge of ensuring that the sanitation
procedures are carried out. All that is required is that the Sanitation
SOP's identify the employee(s) responsible for implementation and
maintenance of the procedures in the Sanitation SOP's. The
establishment does not need to necessarily identify the employee(s) who
will actually perform the sanitation procedures. Also, an
establishment's Sanitation SOP's may have more than one employee
responsible for implementation and maintenance of sanitation
procedures. For example, one employee may be responsible for pre-
operational procedures and another may be responsible for operational
procedures. The rule provides such flexibility.
Further, FSIS is clarifying in this final rule that establishments
must explicitly identify pre-operational sanitation procedures in their
written Sanitation SOP's, distinguishing them from sanitation
activities to be carried out during operations. This will assist both
the establishment and FSIS in identifying which sanitation procedures
are to be carried out each day prior to start-up of operations.
FSIS is also requiring that Sanitation SOP's be signed and dated by
``the individual with overall authority on-site or a higher level
official of the establishment,'' and that the signature shall signify
that the establishment will implement the Sanitation SOP's. This new
language grants establishments greater flexibility than did the
proposed requirement that ``the establishment owner or operator'' be
responsible for implementation of Sanitation SOP's. Additionally, this
final rule specifies that Sanitation SOP's must be signed upon
initiation and upon any modification.
As in the proposal, the format and content of Sanitation SOP's are
not specified in the final regulations. Because there are many types of
inspected establishments that will achieve the required sanitary
conditions in different ways, this rule gives establishments
flexibility to customize their sanitation plans. Each meat and poultry
establishment must analyze its own operations and identify possible
sources of direct contamination that must be addressed in its
Sanitation SOP's.
As proposed, each establishment is required to conduct the pre-
operational and operational procedures as specified in the Sanitation
SOP's, monitor the conduct of the procedures, and routinely evaluate
the content and effectiveness of the SOP's and modify the Sanitation
SOP's accordingly. The Sanitation SOP's must be kept current. The
establishment must evaluate and modify Sanitation SOP's as needed in
light of changes to establishment facilities, personnel, or operations
to ensure they remain effective in preventing direct product
contamination and adulteration. As upon initial implementation,
Sanitation SOP's must be dated and signed by the individual with
overall authority on-site or a higher level official of the
establishment following any modification.
Also as in the proposal, FSIS is requiring that each establishment
initiate corrective action when either the establishment or FSIS
determines that Sanitation SOP's or their implementation may have
failed to prevent direct product contamination or adulteration. The
requirements regarding corrective actions have been more thoroughly
explained, however, and now specify that corrective actions shall
include ``procedures to ensure appropriate disposition of product(s)
that may be contaminated, restore sanitary conditions, and prevent the
recurrence of direct contamination or adulteration of product(s),
including
[[Page 38831]]
appropriate reevaluation and modification of the Sanitation SOP's and
the procedures specified therein.''
This final rule also adopts the provision in the proposal requiring
establishments to keep daily records documenting that sanitation and
monitoring procedures listed in the Sanitation SOP's are performed.
Establishments also must maintain records documenting any corrective
actions taken to prevent direct contamination or adulteration of
products, or when the establishment determines or FSIS notifies the
establishment that its Sanitation SOP's are inadequate. FSIS has
clarified that such records must be initialed and dated by the
designated establishment employee(s) responsible for the implementation
and monitoring of the Sanitation SOP's procedures.
In response to comments, FSIS has revised the recordkeeping
requirements to allow for computer maintenance of records, as long as
establishments implement controls to ensure the integrity of the
electronic data. FSIS recognizes that many establishments currently use
computers for maintaining a variety of types of information, including
sanitation data. It would be impractical and burdensome to prohibit
these establishments, or others wishing to use computers, from using
computers to record and store required sanitation data.
FSIS proposed that establishments must maintain sanitation records
for a minimum of six months, but did not specify whether these records
had to be stored on-site. Several commenters expressed concern about
the physical location of establishment sanitation records and
questioned whether sanitation records must be maintained in the
establishment.
FSIS requires unimpeded access to all establishment sanitation
records for oversight and enforcement purposes; these records are to be
an integral part of the Agency's inspection activities. FSIS
anticipates that, for most establishments, these records will not be
voluminous and will not create a significant storage problem. However,
the Agency recognizes that space may be limited at certain inspected
facilities and has revised this requirement to allow establishments to
retain records off-site, provided they are not removed from the
establishment for at least 48 hours following completion and they can
be provided to FSIS personnel within 24 hours of being requested.
In this final rule, FSIS is clarifying that it will verify that the
Sanitation SOP's are being implemented and maintained, and that they
are effective. FSIS inspectors will ensure not only that an
establishment is complying with the requirement to develop, implement,
and maintain Sanitation SOP's, and to maintain daily records for them,
but also that the Sanitation SOP's are in fact working. Inspectors will
review the Sanitation SOP's, the daily records, the conduct of
procedures specified in the Sanitation SOP's, and the sanitary
conditions themselves.
The failure by an establishment to comply with the Sanitation SOP's
regulations may initiate regulatory action. The full array of
compliance tools includes process deficiency reports, tagging of
equipment or areas, retention of product, letters of warning, and
suspension and withdrawal of inspection. The nature of FSIS's response
will depend on the circumstances. Minor omissions or errors in
Sanitation SOP's documentation, not symptomatic of larger ``system''
problems, will result in regulatory action commensurate with the
severity of the violation. For example, process deficiency reports
might be issued to direct corrective action. However, a pattern of
violations of the Sanitation SOP's provisions would lead to additional
responses, with persistent and serious failures resulting in suspension
or withdrawal of inspection from the establishment. Suspensions and
withdrawals would be made in accordance with applicable rules of
practice for those proceedings.
If FSIS determines that an establishment's Sanitation SOP's fail to
include procedures to prevent direct product contamination or
adulteration or that required records are not being kept, the Agency
may tag affected facilities and equipment and suspend inspection until
the failure is remedied. Because the tagging of insanitary facilities
and equipment is based on current statutory authority, the specific
regulatory provisions for tagging in the proposal are not retained in
this final rule.
Verification and compliance activities under the Sanitation SOP's
provisions are distinguishable from actions taken as a consequence of a
finding of product adulteration under the sanitation requirements
elsewhere in the regulations. As a practical matter, however, such
findings are likely to be connected. A finding of deficient Sanitation
SOP's or Sanitation SOP's records may prompt additional inspection
activity directed at determining whether or not product contamination
or adulteration has occurred. If it has, FSIS will take appropriate
action to prevent adulterated product from entering commerce and, where
necessary, seek recall of product that has already entered commerce.
Finally, the Sanitation SOP's requirements of this final rule are
set out in a new Part 416, Sanitation. These provisions are formatted
differently from the proposal to comport with FSIS's announced project
to reform, reorganize, and recodify the meat and poultry regulations.
This regulatory reform project is well underway, and will, among other
things, eliminate unneeded regulations by combining, to the extent
possible, the currently separate meat and poultry regulations. New Part
416, like new part 417 on HACCP, covers both meat and poultry products.
Part 416 will be expanded and supplemented as the Agency proceeds with
its initiative to review, reform, and reorganize existing FSIS
regulations concerning sanitation.
Comments and Responses
General
Support for the proposed requirements for Sanitation SOP's was
expressed by a wide range of commenters. Most supporters agreed that
establishment sanitation is essential to product safety and that every
meat and poultry establishment should be required to have a written
sanitation plan. Those who opposed mandatory Sanitation SOP's argued
that current sanitation regulations would be adequate if they were
better enforced, that Sanitation SOP's would be no more than a
paperwork exercise, and that they would be an additional burden on
establishments. FSIS strongly disagrees with the notion that Sanitation
SOP's will be a mere ``paperwork exercise,'' and believes this
regulation will, in fact, result in improved sanitation and provide for
more effective enforcement of the sanitation requirements.
Substantial evidence exists that insanitary facilities or
equipment, poor food handling, improper personal hygiene, and similar
insanitary conditions create an environment in which products become
contaminated with microorganisms, including pathogens. While sanitation
has improved greatly throughout the industry over the years, some
individual establishments still have difficulty getting their
facilities and equipment ready to start operations each day and keeping
conditions sanitary during establishment operations. FSIS affirms that
proper sanitation is an important and integral part of every food
process and a fundamental requirement of the inspection laws that the
Agency enforces.
[[Page 38832]]
In the past, FSIS has enforced the sanitation requirements
primarily through a combination of prescriptive sanitation regulations,
detailed guidance materials, and direct, hands-on involvement by
inspectors in day-to-day pre-operational and operational sanitation
procedures in inspected establishments. This system achieved sanitation
goals on a daily basis in individual establishments, but at a
relatively large public cost because it encouraged establishments to
shift accountability for sanitation to the FSIS inspector. For example,
in the past, FSIS inspectors have taken responsibility for checking
sanitation in every slaughter establishment before it begins daily
processing. In extreme cases, inspectors have led daily ``bucket
brigades'' of slaughter establishment employees through pre-operational
establishment cleanup. In these circumstances, FSIS has, in effect,
taken responsibility for establishment sanitation conditions. The
Sanitation SOP's requirement is intended to end this practice.
Sanitation SOP's make it clear that responsibility for identifying and
conducting procedures needed to maintain sanitary conditions rests with
the establishment, not with FSIS.
Sanitation SOP's are an inspection tool. They will help individual
inspectors focus their oversight in an establishment on those
conditions that pose a risk of direct product contamination or
adulteration, that is, on conditions which pose the greatest
adulteration hazards to products subject to inspection in that
establishment. The effectiveness of each establishment's Sanitation
SOP's in achieving acceptable sanitation will be subject to continuing
verification by FSIS inspectors through direct observation of
conditions in the establishment. It is expected that, over time,
inspectors in most establishments will increasingly be able to rely on
a review of daily Sanitation SOP's records to determine whether
establishments are complying with sanitation requirements. However,
FSIS inspectors will continue to have a full array of regulatory tools
to ensure the maintenance of sanitary conditions. For instance, FSIS
inspectors will continue tagging equipment, utensils, rooms, or
compartments in instances where there is physical evidence of
insanitary conditions in the production areas of the establishment.
FSIS anticipates that the development, implementation, and
maintenance of Sanitation SOP's, as well as the recordkeeping
provisions, will impose a minimal burden on establishments. Some
establishments already utilize written Sanitation SOP's. For other
establishments, compliance with the Sanitation SOP's requirements will
consist of recording their current sanitation practices. A complete
discussion of the anticipated costs of implementing the SOP's
requirements is contained in the Final Regulatory Impact Analysis.
Sanitation SOP's are an integral part of the Agency's strategy for
making inspection more effective and more risk-based in its focus. For
these reasons, FSIS is adopting the proposed requirements for
Sanitation SOP's and is clarifying that developing, implementing, and
maintaining Sanitation SOP's and keeping daily Sanitation SOP's
records, is a condition of inspection.
Development of Sanitation SOP's
As noted previously, a number of commenters raised concerns about
the content of the Sanitation SOP's and asked for more specificity.
Some commenters recommended that FSIS be more specific about what
procedures must be in the Sanitation SOP's. Other commenters suggested
that such procedures be fully described and be made mandatory. The
Agency recognizes these commenters' concerns and therefore is providing
guidance on how individual establishments may develop their Sanitation
SOP's in Appendix A and Appendix B to this final rule. Appendix A is a
guideline on Sanitation SOP's that establishments can use in developing
their own Sanitation SOP's; Appendix B is a model of an establishment's
Sanitation SOP's that demonstrates what a completed Sanitation SOP's
might include. Together, these guidance documents will assist
establishments to develop Sanitation SOP's that address conditions
unique to individual establishments and processes and that prevent
direct product contamination or adulteration. As with all FSIS guidance
materials, the Agency welcomes comments on how these two documents
might be improved.
However, the final rule itself remains nonprescriptive in that it
requires each establishment to determine for itself what procedures are
necessary to prevent insanitary conditions that will cause direct
product contamination or adulteration. Overall, the comments confirmed
that, while proper sanitation is a common need in every food production
facility, the means to achieve it are diverse and establishment-
specific. Establishments that now have good sanitation and effective
process controls are expected to continue using techniques that work in
their establishment. Other establishments will need to analyze and
select effective abatement procedures among various alternatives for
attaining a sanitary processing environment. What works in one
establishment may or may not work in another.
The proposed rule also solicited comments as to whether FSIS should
mandate Good Manufacturing Practices (GMP's) for all or certain
Sanitation SOP's. FSIS listed illustrations in the proposal of elements
that might be mandatory elements of Sanitation SOP's. Although some
commenters expressed support for making GMP's or other practices
mandatory, many objected to such specific requirements on the basis
that they would be infeasible. FSIS agrees with those commenters who
stated that detailed GMP regulations are infeasible because of the
difficulty in making them specific enough to be useful. FSIS also was
concerned that such specificity could result in lost flexibility.
For these reasons, this final rule will not prescribe a single
format for individual establishment Sanitation SOP's or mandate
specific GMP's. It will be the responsibility of each establishment to
consider existing FSIS regulations and guidelines; evaluate its
facilities, processes, and sanitation conditions; determine what
sanitation procedures must be implemented to prevent direct product
contamination or adulteration; and describe these procedures in
Sanitation SOP's.
Maintaining Sanitation SOP's
FSIS received several comments regarding the maintenance of
Sanitation SOP's. Some commenters wanted to know whether if an
establishment will be able to update its Sanitation SOP's to
incorporate new technologies. Other commenters wanted to know what type
of system, if any, FSIS will use to review changes to Sanitation SOP's
and if a formal request for FSIS review or approval would be required.
As has been discussed previously, the final rule requires that each
establishment develop, implement, and maintain its Sanitation SOP's and
incorporate new sanitation technologies as appropriate. FSIS encourages
the adoption of new technologies that can improve sanitation and food
safety. This is an establishment responsibility. Although FSIS will not
approve Sanitation SOP's, it will provide advice and guidance to
establishments as they develop and begin to implement Sanitation SOP's.
Recordkeeping
Commenters also expressed concerns about what was to be in daily
sanitation
[[Page 38833]]
records and how long and where such records were to be retained. As the
proposal explained, and this final rule requires, Sanitation SOP's
records must document the implementation and maintenance of Sanitation
SOP's, as well as any deviations from Sanitation SOP's procedures, and
corrective actions taken. As with the development of Sanitation SOP's
themselves, FSIS will allow each establishment to determine the form
and format of its daily sanitation records. In many establishments, a
simple, daily checklist, showing that specific Sanitation SOP's
procedures were implemented, initialed by the responsible establishment
employee, is likely to suffice. Other establishments may find a more
detailed format for its records is more useful. Some establishments may
wish to use a computer-based system. This final rule provides such
flexibility.
Some commenters stated that the proposed six-month retention of
daily sanitation records was too long. FSIS disagrees and is adopting
the proposed requirement that establishments retain Sanitation SOP's
records for six months. Increased product shelf-life and the potential
need for FSIS personnel to review Sanitation SOP's records many months
after production make it necessary that establishments retain records
for six months. Furthermore, sanitation records provide both FSIS and
establishment management near-term trend data to evaluate how
establishment sanitation is being carried out under the Sanitation
SOP's. This feedback should be very useful to establishments in
determining whether and how their Sanitation SOP's need revision.
Inspectors will benefit, too, from knowing how the establishment has
complied with these requirements. Establishment sanitation records will
also need to be reviewed by the Agency as part of any compliance
investigation.
In a related matter, several commenters expressed concern about the
physical location of establishment sanitation records and questioned
whether sanitation records must be maintained in the establishment. As
explained above, FSIS requires unimpeded access to all establishment
sanitation records for oversight and enforcement purposes. FSIS
anticipates that, for most establishments, these records will not be
voluminous and will not create a significant storage problem. However,
in response to these comments, this final rule will allow
establishments to retain Sanitation SOP's records off-site provided
they are not removed from the establishment for at least 48 hours
following completion and they can be provided to FSIS personnel within
24 hours of request.
Some commenters also expressed concern about public accessibility
to an establishment's Sanitation SOP's records. Like establishment
HACCP records, these records are kept and maintained by the
establishment and generally are not Agency records. Occasionally,
however, such records will be copied and incorporated into Agency
records for some official purpose. These records will be disclosed to
third parties only to the extent disclosure is required by the Freedom
of Information Act and the Privacy Act or other applicable law.
Proprietary information, personal information, and other information
exempt from disclosure would be protected.
``Layering''
Many commenters were concerned that FSIS was layering requirements
for Sanitation SOP's over existing regulations governing establishment
sanitation practices, thereby increasing rather than decreasing
intrusive, command-and-control oversight of all inspected
establishments. Concern was also expressed that the new requirements
might conflict with current sanitation regulations.
FSIS does not consider the Sanitation SOP's requirement to be
layered over or in conflict with existing regulations. Existing
regulations establish substantive sanitation-related requirements,
while the new Sanitation SOP's provisions establish a means by which
establishments will take responsibility for achieving sanitary
conditions and preventing direct product contamination or adulteration.
Sanitation SOP's also will better focus inspection oversight by FSIS
inspectors on those sanitation measures required to prevent direct
product contamination or adulteration. As discussed, one of the
Agency's goals is to reduce inspectors' personal involvement in the
conduct of routine, day-to-day sanitation procedures.
FSIS emphasizes that it does not intend or require that an
establishment's Sanitation SOP's incorporate all elements of the
existing FSIS sanitation regulations. These regulations contain many
detailed provisions that do not relate to the prevention of direct
product contamination. As the text of the Sanitation SOP's regulations
and the guidance materials at Appendices A and B makes clear, FSIS
intends and requires only that the Sanitation SOP contain a description
of the procedures an establishment will follow to address the elements
of pre-operational and operational sanitation that relate to the
prevention of direct product contamination.
For example, under paragraph (a) of Sec. 308.4 of the regulations,
FSIS requires that ``Dressing rooms, toilet rooms, and urinals shall be
sufficient in number, ample in size, and conveniently located.''
Although compliance with this requirement is important for the
maintenance of establishment sanitation, and employee hygiene must be
part of Sanitation SOP's, Sec. 308.4(a) does not concern direct product
contamination and would not need to be addressed in an establishment's
Sanitation SOP's. On the other hand, the rule requires that Sanitation
SOP's specifically address the pre-operational ``cleaning of food
contact surfaces of facilities, equipment, and utensils'' because these
procedures are necessary to prevent the direct contamination of
product. Additionally, the guidance materials in Appendices A and B
give examples of other procedures necessary to prevent direct product
contamination that Sanitation SOP's should include, such as
``Descriptions of equipment disassembly, reassembly after cleaning, use
of acceptable chemicals according to label directions, and cleaning
techniques.'' FSIS emphasizes, however, that an establishment does not
need to reproduce in its written Sanitation SOP's the existing
regulatory requirements concerning the prevention of direct
contamination or adulteration of product.
FSIS also realizes that its existing sanitation regulations contain
some detailed and prescriptive provisions and that some of those
regulations may be outmoded and no longer needed in light of the
Agency's effort to clarify that good sanitation is the responsibility
of each establishment. FSIS will continue to review, reevaluate, and
revise, as necessary, all current sanitation regulations, along with
related issuances and sanitation inspection procedures, to simplify and
streamline them and make them more compatible with Sanitation SOP's
requirements. This process was announced and initiated in the advance
notice of proposed rulemaking published on December 29, 1995 (60 FR
67469). The review of sanitation regulations is a high priority for the
Agency. The elements of sanitation that are required to be addressed in
the Sanitation SOP's will remain as central elements of the FSIS
sanitation regulations. Establishments will not need to revise their
Sanitation SOP's because of the simplification and streamlining of
existing FSIS sanitation regulations.
[[Page 38834]]
Role of Inspectors
A related concern of many commenters was the role FSIS inspectors
will play in the development and enforcement of Sanitation SOP's. Some
commenters expressed concern that during inspection inspectors would
rely solely on record reviews instead of actually observing
establishment conditions. Other commenters expressed concerns that
Sanitation SOP's would merely provide FSIS inspectors with more
latitude to make intrusive and arbitrary decisions.
FSIS strongly disagrees with this characterization of Sanitation
SOP's and the role of the Agency's inspection personnel. Industry's
responsibility for producing safe meat and poultry and FSIS's
responsibility for regulatory oversight are fundamentally different.
Sanitation SOP's are the establishment's commitment to FSIS that they
will consistently provide a sanitary environment for food production.
FSIS inspectors will not be tasked with directing an establishment's
sanitation procedures, nor with ``approving'' the establishment's
Sanitation SOP's. They will, however, verify that the Sanitation SOP's
are being implemented and that they are effective in preventing direct
product contamination and adulteration.
Oversight of Sanitation SOP's will become an increasingly important
part of daily inspection activity, while the directing of sanitation
activities will occur less frequently. Periodic inspection tasks will
include verifying that Sanitation SOP's meet the regulation's
requirements, are being implemented and maintained, and are effective
in producing sanitary conditions. FSIS inspectors' oversight will
include review of the Sanitation SOP's and required records, direct
observation of the implementation and monitoring of the Sanitation
SOP's, and visual observation of sanitary conditions in the production
areas of the establishment.
FSIS expects that establishments will rely less on inspectors to
direct them in maintaining sanitary conditions as establishments rely
more on adherence to their own Sanitation SOP's. The mix of inspector
tasks that comprise sanitation inspection also will change. As
establishments adopt and successfully implement Sanitation SOP's, and
consistently achieve good sanitation results, FSIS inspectors can spend
less time ensuring that basic sanitation requirements are being met.
Conversely, to the extent some establishments do not implement
effective Sanitation SOP's and consistently achieve good sanitation,
FSIS inspectors will be obliged to intensify their focus on actual
establishment conditions and initiate appropriate enforcement actions.
Ensuring establishments operate under sanitary conditions should be
made easier for inspectors, and ultimately permit inspectors to spend
more time on other tasks. One purpose of the Sanitation SOP's
regulations is to help inspectors, as well as establishments, focus
their attention on those aspects of establishment sanitation that pose
the most risk of causing product contamination or adulteration. Under
the current inspection system, inspectors look at all aspects of
establishment sanitation, including many that have a relatively low
probability of causing product contamination. In the future, normal
oversight activities will focus more on whether an establishment is
following its Sanitation SOP's and thereby consistently preventing, or
as appropriate, correcting, conditions that cause direct product
contamination or adulteration. Some commenters were concerned about the
effect on establishment operations if inspection personnel, when
enforcing the Sanitation SOP's requirements, reject one piece of
equipment, utensil, room or compartment as insanitary. As previously
stated, inspectors will take prompt action in cases where there is a
finding of insanitation or the likelihood of product contamination or
adulteration. The type and intensity of this response will vary. For
example, establishment operations may be allowed to continue if
inspection personnel determine that a rejected item, compartment or
room is not related to other processes or products being produced.
However, inspection would be withheld in rooms, departments, or
facilities associated with the production of contaminated or
adulterated products where the establishment can not show FSIS that
they have isolated the cause of the contamination or adulteration and
have taken appropriate action to prevent further contamination or
adulteration. In a similar vein, commenters also stated that
establishments should not be penalized for the occurrence of a
sanitation problem that is effectively abated. These commenters
suggested that ``U.S. Rejected'' tags should be used only if an
establishment fails to identify and correct insanitary conditions. If
the establishment takes proper corrective action, they argued, it
should be viewed as evidence that the Sanitation SOP's is being
adequately implemented. FSIS agrees. Establishments that identify and
correct insanitary conditions in a timely manner and make proper
disposition of any affected product will be considered to be in
compliance with the Sanitation SOP's regulations.
Although FSIS fully expects that the clarification of
establishments' sanitation responsibilities will lead to better and
more consistent compliance with sanitation requirements, the Agency
recognizes that this will not be the case in all establishments.
Establishments that fail to comply with the requirements in this final
rule for Sanitation SOP's will be subject to appropriate compliance and
regulatory action that will, when necessary, include suspension or
withdrawal of inspection. Further, as noted in the proposal, anyone who
intentionally falsifies records will be subject to criminal
prosecution.
FSIS also recognizes commenters' concerns about its rules of
practice and due process procedures. FSIS expects that these concerns
will be addressed through changes to these procedural requirements
initiated as a result of the Agency's regulatory reform project. These
subjects are also on the agenda for discussion at FSIS's upcoming
implementation conferences.
Relation to HACCP
Another important topic raised by commenters was the link between
an establishment's Sanitation SOP's and its HACCP plan. This link was
unclear to some who stated the two were redundant. HACCP plans aim at
ensuring safety at specific critical control points within specific
processes, while Sanitation SOP's typically transcend specific
processes. Sanitation SOP's are important tools for meeting existing
statutory sanitation responsibilities and preventing direct product
contamination or adulteration. As such, it is appropriate that they be
developed and implemented in the near-term prior to implementation of
HACCP. In a sense, the Sanitation SOP's are a prerequisite for HACCP.
It is anticipated that some procedures addressed in an establishment's
Sanitation SOP's might eventually be incorporated into an
establishment's HACCP plan. Other procedures in an establishment's
Sanitation SOP's, including those addressing pre-operational sanitation
procedures for cleaning facilities, equipment, and utensils, will most
likely remain in the Sanitation SOP's. A sanitation procedure that is
incorporated into a validated HACCP plan need not be duplicated in the
Sanitation SOP's.
[[Page 38835]]
Training
A number of comments expressed concern about the content of
inspector training, suggesting that inadequate training would result in
inconsistent enforcement of the rule. Assurance was requested that
inspectors would be trained to consistently monitor Sanitation SOP's.
FSIS recognizes that inspectors must be trained to react as regulators
rather than as quality control consultants or establishment sanitarians
when a sanitation or other health and safety problem is discovered in
an establishment. A primary focus of agency training sessions will be
to attain this goal.
Also, some commenters asked whether joint FSIS and industry
training would be offered. FSIS does not plan to allow industry to
attend Agency training sessions. However, FSIS does plan to hold
informational briefings for industry personnel. These will be the
subject of future notices in the Federal Register.
Pre-Operation Sanitation Inspection
Some commenters asserted that establishments with good Sanitation
SOP's should be permitted to start daily operations on their own,
instead of having to wait for an inspector to conduct a pre-operational
sanitation inspection and allow operations to start. FSIS agrees with
these commenters. Accordingly, upon the effective date of this rule and
implementation of Sanitation SOP's, establishments not otherwise
notified by FSIS may begin daily processing upon completion of pre-
operational sanitation activities without the prior approval of an
inspector.
Extending the implementation date for Sanitation SOP's will also
give FSIS additional time to provide needed training, instruction and
management support to FSIS inspection personnel tasked with enforcing
the Sanitation SOP's requirements.
Implementation Date
Finally, many commenters expressed concern about the amount of time
they said it would take to prepare and implement effective Sanitation
SOP's. These commenters requested more lead time to implement these
requirements. FSIS agrees that some establishments may need more time
than the 90 days the proposed rule provided for implementing Sanitation
SOP's requirements. Consequently, FSIS is modifying this aspect of the
proposal. This final rule will provide establishments six months from
the effective date of this regulation to develop and implement written
Sanitation SOP's. This additional time will allow these establishments
to initially develop and refine their Sanitation SOP's to best meet
operational needs before the effective date of the Sanitation SOP's
requirements. Extending the implementation date for Sanitation SOP's
will also give FSIS additional time to provide needed training,
instruction, and management support to personnel tasked with enforcing
the Sanitation requirements.
IV. Microbiological Performance Criteria and Standards
Summary of Proposal
As part of the Pathogen Reduction/HACCP proposal, FSIS proposed
interim targets for the reduction of Salmonella for the major species
and for ground meat and poultry. Further, FSIS proposed to require
daily testing by slaughter establishments and establishments producing
raw ground product in order to verify achievement of the Salmonella
targets on an ongoing basis. The proposal reflected a central tenet of
the FSIS food safety strategy: to be effective in improving food safety
and reducing the risk of foodborne illness, HACCP-based process control
must be combined with objective means of verifying that meat and
poultry establishments are achieving acceptable levels of food safety
performance.
FSIS explained in the preamble to the proposal that food safety
performance standards, in the form of tolerances or other limits, have
been an important feature of the food safety regulatory system for
chemical residues (such as those resulting from the use of animal drugs
and pesticides) and for pathogenic microorganisms in ready-to-eat meat
and poultry products (such as Listeria monocytogenes in ready-to-eat
products and Salmonella in cooked beef). However, performance standards
have not in the past been incorporated into the regulatory system for
pathogens on raw meat and poultry products.
FSIS recognizes that establishing performance standards for
pathogens on raw products raises different and difficult issues. The
microbiological safety of a meat or poultry product at the point of
final sale or consumption is affected by many factors. Most
significantly, unlike other kinds of contaminants, microbiological
pathogens can be introduced at many points on the farm-to-table
continuum, and once in the product, under certain conditions, the
bacteria can multiply. Some pathogens, such as E. coli O157:H7, are so
virulent that a small number of organisms can pose a significant
hazard. Indeed, on that basis the Agency has determined that any amount
of E. coli O157:H7 will adulterate a meat or poultry product. On the
other hand, some pathogens, such as Salmonella, ordinarily must
multiply to relatively large numbers to cause illness, although the
susceptibility of individuals to illness varies widely. Certain
segments of the population, such as the very young, the elderly, and
persons with compromised immune systems, are particularly vulnerable to
illnesses caused by Salmonella and other foodborne pathogens.
Therefore, FSIS has not taken the position in this rulemaking that
some amount of a pathogen necessarily renders a raw meat or poultry
product unsafe and legally adulterated; the proposed targets for
pathogen reduction would not have served as a standard for determining
whether any particular lot of raw product could be released into
commerce. The proposed targets were intended instead as an initial step
toward defining levels of food safety performance that establishments
would be required to achieve consistently over time. The interim
targets and the required testing by establishments were also intended
as a first step toward the eventual incorporation of microbial testing
as an integral part of process-control validation and verification in
facilities operating under HACCP.
Salmonella was selected as the target organism because it is the
most common cause of foodborne illness associated with meat and poultry
products. It is present to varying degrees in all major species. And,
interventions targeted at reducing Salmonella may be beneficial in
reducing contamination by other enteric pathogens.
As interim targets for pathogen reduction, FSIS proposed that the
prevalence of Salmonella contamination in each of the major species and
in raw ground products be reduced by each establishment to a level
below the current national baseline prevalence as measured by the FSIS
Nationwide Microbiological Baseline Data Collection Programs and
Nationwide Microbiological surveys (collectively referred to below as
the FSIS baseline surveys) or other available data.
Role of Microbiological Performance Criteria and Standards in FSIS Food
Safety Strategy
As explained in the ``Background'' section of this preamble, the
most important objective of this rulemaking is to build into food
production processes and the FSIS system of regulation and oversight,
effective measures to reduce and control pathogenic microorganisms
[[Page 38836]]
on raw meat and poultry products. FSIS has concluded that HACCP-based
process control combined with appropriate microbiological performance
criteria and standards will achieve this objective.
Because the current regulatory system lacks any performance
criteria or standards for harmful bacteria on raw products (other than
with respect to E. coli O157:H7 on raw ground beef), FSIS inspectors
have no adequate basis for judging whether establishments producing raw
meat and poultry products are dealing effectively with the food safety
hazard posed by harmful bacteria.
The HACCP requirements discussed in the preceding section of this
preamble will ensure that all meat and poultry establishments implement
science-based process controls designed to prevent and reduce the
significant food safety hazards that arise in their particular
production processes and products. For slaughter establishments and
other establishments producing raw meat and poultry products, this will
mean developing controls that address the hazards posed by pathogenic
microorganisms as well as other biological, chemical and physical
hazards. HACCP principles provide the framework by which establishments
target and reduce harmful bacteria on raw meat and poultry products.
To be successful in ensuring food safety, however, HACCP must be
coupled with appropriate performance criteria and standards against
which the effectiveness of the controls developed by each establishment
can be validated and verified. For example, controls designed to
prevent the contamination of processed, ready-to-eat meat and poultry
products with harmful bacteria would have to be validated as effective
in meeting the already-existing requirement that such products be free
of harmful bacteria. Without such performance criteria and standards,
there would be no objective basis for determining whether a particular
HACCP plan is adequate for its food safety purpose. Additionally, there
would be no way to determine whether industry or FSIS had met their
respective food safety responsibilities.
In this rulemaking, FSIS for the first time proposed
microbiological performance standards for raw products. The need for
some measure of performance in the area of microbiological
contamination was generally supported by the comments FSIS received on
its proposal. In response to the comments, FSIS has refined and
improved its proposed approach, and is establishing microbiological
performance standards for reduction of Salmonella in raw products,
coupled with performance criteria for use with E. coli testing to
verify the effectiveness of process controls in slaughter
establishments.
These new provisions are the first steps in what FSIS expects to be
a long-term effort to ensure that appropriate microbial testing is
conducted, and appropriate criteria and standards exist, to reduce the
food safety hazards posed by harmful bacteria on raw meat and poultry
products. The numerical targets for both the performance criteria and
the pathogen reduction performance standards are likely to be changed
as new data become available. The targets currently are set at the
national baseline prevalence of contamination and reflect what is
achievable using available technology. FSIS intends to repeat
periodically its baseline surveys, on which the criteria and standards
are based. FSIS will collect additional data on Salmonella by testing
products in establishments pursuant to the performance standards and on
E. coli through close monitoring of establishments' experience and test
results associated with that mode of process control verification.
These new data, together with relevant epidemiologic data, scientific
research, and new technologies, will be considered by FSIS when
proposing future revisions to the performance criteria and testing
requirements for E. coli and the pathogen reduction performance
standards for Salmonella. New information and data also may support
different standards and different approaches to microbial testing.
FSIS is committed to the development and implementation of future
performance standards, as needed, to achieve the FSIS's public health
goal of reducing the incidence of foodborne illness associated with
harmful bacteria on raw meat and poultry products. FSIS is also
concerned that standards achieve this public health goal in a manner
that encourages industry innovation and minimizes regulatory burdens on
the regulated industry. The pathogen reduction performance standards
promulgated in this regulation will be implemented on the basis of a
statistical evaluation of the prevalence of bacteria in each
establishment's products, measured against the nationwide prevalence of
the bacteria in the same products. These standards will not be used to
judge whether specific lots of product are adulterated under the law.
As more research is done and more data become available, and as more
sophisticated techniques are developed for quantitative risk assessment
for microbiological agents, it may be possible and appropriate to
develop performance standards that use a different approach.
Consideration may also be given to the possibility of establishing
similar standards for other pathogenic microorganisms. FSIS will
continue to work with the scientific community in this area.
The microbiological performance standards set out in this
rulemaking are part of a fundamental shift in FSIS regulatory
philosophy and strategy. The current inspection system relies heavily
on intensive ``command-and-control'' prescription of the means by which
meat and poultry establishments must achieve statutory objectives
concerning food safety, sanitation, product wholesomeness, and
prevention of economic adulteration and misbranding. As explained in
the ``Background'' section of this preamble, in FSIS's ANPR ``FSIS
Agenda for Change: Regulatory Review,'' and in the January, 1996,
National Performance Review report ``Reinvention of Food Regulations,''
FSIS plans to shift from this reliance on command and control
regulations to much greater reliance on performance standards. FSIS
believes that public health and consumer protection goals can be
achieved more effectively, in most cases, by converting command-and-
control regulations to performance standards, which provide industry
with the flexibility to devise the optimal means of achieving food
safety objectives. FSIS would verify compliance with such performance
standards through inspection and other forms of oversight.
Overview of Final Rule
Comments on the proposed rule's microbial testing provisions have
resulted in a number of changes to those provisions. As discussed in
the ``Response to Comments'' section, below, FSIS received numerous
comments supporting the concept of microbiological performance criteria
or standards, but also received many comments urging alternatives to
the specific approach proposed by FSIS, including testing for organisms
other than Salmonella.
The Agency actively sought out comment and information on the issue
of target organism(s) to be selected for process control verification
and pathogen reduction purposes in this regulation. In the proposal,
FSIS stated that ``the Agency recognizes that there are other foodborne
human pathogens of public health concern that can be isolated from raw
meat and poultry product. The Agency would welcome
[[Page 38837]]
comments on the targeting of other pathogens in addition to or in lieu
of Salmonella'' (60 FR 6800). As noted earlier in this preamble, during
the comment period FSIS held many meetings to solicit comment on
various issues, including microbiological criteria and standards.
Microbiological criteria and standards were discussed in detail at the
FSIS-sponsored scientific conference held in Philadelphia,
Pennsylvania, on May 1 and 2, 1995, titled ``The Role of
Microbiological Testing in Verifying Food Safety.'' This conference was
open to the public and was announced in the Federal Register on March
24, 1995 (60 FR 15533). An expert panel at that conference endorsed the
role of microbiological testing in accordance with appropriate criteria
or standards, but suggested that mandatory establishment testing focus
on a quantitative assay for generic E. coli rather than the proposed
qualitative assay for Salmonella. The panel stated that a quantitative
assay for the more commonly occurring generic E. coli is a more
effective process control indicator with respect to the prevention of
contamination of meat and poultry by feces and associated bacteria.
FSIS also held a series of six issue-focused public meetings in
September, 1995. During a preliminary public meeting on August 23,
1995, at which issues were identified and the meeting agenda was
established, participants decided that a full day should be devoted to
further public discussion of pathogen reduction standards and microbial
testing. The agenda for the six meetings appeared in the Federal
Register on August 31, 1995 (60 FR 45381). The issues discussed on
September 27 included: (1) the scientific and policy basis for
establishing targets; (2) whether Salmonella is the appropriate
organism for some or all species; (3) whether other pathogens would be
preferable for some or all animal species; (4) the utility of targets
for E. coli or other non-pathogenic indicator organisms as a means of
controlling and reducing pathogenic microorganisms; (5) the advantages
and disadvantages of targets based on the prevalence of detectable
contamination vs. targets based on the number of organisms present; and
(6) the need for pathogen reduction targets for raw ground products in
general and in establishments that both slaughter animals and produce
ground product.
At the September 27, 1995, issue-focused meeting, there was
additional comment in favor of testing for an organism other than
Salmonella, such as generic E. coli, that has a strong track record in
the industry as a good organism to use for process control verification
testing. There was, however, continued strong support for raw product
testing targeted at pathogens, such as Salmonella, and support for
pathogen reduction as the primary goal of such testing.
At the meetings, FSIS distributed issue papers on the various
issues being addressed, based in large part on comments already
received. The issue paper on Pathogen Reduction Performance Standards
and Microbial Testing stated that the two most common concerns in the
comments received to that date were the proposed selection of
Salmonella as the indicator organism and the frequency of proposed
testing. It stated that although some commenters recommended finalizing
Salmonella testing, others recommended using E. coli instead of or in
addition to Salmonella. The issue paper stated the Agency's current
thinking on the organism to be selected, the need for daily testing at
every establishment, and the necessity of testing each species
slaughtered and each ground product produced. In the issue paper FSIS
stated, among other things, that it was ``seriously considering generic
E. coli as the process control indicator organism and the adoption of a
quantitative E. coli standard as a measure of process control with
respect to the prevention and reduction of fecal contamination in
slaughter plants.'' FSIS also stated that it was considering setting
forth pathogen-specific performance standards as a direct measure of
accountability for controlling and reducing harmful bacteria in raw
meat and poultry products and that Salmonella targets might be adopted
as performance standards and enforced by FSIS through its own
compliance monitoring. The Agency published the issue papers in the
Federal Register on October 24, 1995 (60 FR 54450).
Based on the large body of written and oral comments FSIS has
received on this issue, the Agency has decided not to use Salmonella
both as a target for pathogen reduction and as an indicator of process
control. FSIS has decided to adopt pathogen reduction performance
standards targeting Salmonella, as proposed, except that FSIS, not the
establishments, will conduct testing for the pathogen to verify
compliance. FSIS also has decided to require establishments
slaughtering livestock and poultry to conduct routine testing for
generic E. coli (instead of the proposed use of Salmonella tests) as an
ongoing, objective process control indicator for fecal contamination,
and to establish performance criteria by which results can be
evaluated.
Process Control Verification Performance Criteria
Under the FMIA and the PPIA, meat and poultry establishments
inspected by FSIS are required to maintain sanitary conditions
sufficient to prevent contamination of products with filth and to
prevent meat and poultry products from being rendered injurious to
health (21 U.S.C. 601(m) and 608 (FMIA); 21 U.S.C. 453 (g) and 456
(PPIA)). A grant of inspection by FSIS is contingent upon an
establishment meeting this responsibility. FSIS is authorized by law to
issue regulations establishing appropriate sanitation requirements.
Meat and poultry products are deemed legally adulterated, whether or
not they are shown to be contaminated, if prepared, packed, or held
under insanitary conditions whereby they may have become contaminated
with filth or may have been rendered injurious to health.
In slaughter establishments, fecal contamination of carcasses is
the primary avenue for contamination by pathogens. Pathogens may reside
in fecal material and ingesta, both within the gastrointestinal tract
and on the exterior surfaces of animals going to slaughter. Therefore,
without care being taken in handling and dressing procedures during
slaughter and processing, the edible portions of the carcass can become
contaminated with bacteria capable of causing illness in humans.
Additionally, once introduced into the establishment environment, the
organisms may be spread from carcass to carcass.
Because the microbial pathogens associated with fecal contamination
are the single most likely source of potential food safety hazard in
slaughter establishments, preventing and removing fecal contamination
and associated bacteria are vital responsibilities of slaughter
establishments. Further, because such contamination is largely
preventable, controls to address it will be a critical part of any
slaughter establishment's HACCP plan. Most slaughter establishments
already have in place procedures designed to prevent and remove visible
fecal contamination.
There is general agreement within the scientific community that
generic E. coli is the best single microbial indicator for fecal
contamination. FSIS, therefore, is requiring that establishments
slaughtering livestock or poultry begin testing for E. coli (E. coli,
biotype I, nonspecific as to species, hereinafter referred to simply as
E. coli) at the
[[Page 38838]]
frequency and following the procedures described in ``Process Control
Verification; E. coli Performance Criteria and Testing'' section,
below, 6 months after publication of the final rule. FSIS considers the
required testing to be essential for meeting current statutory
requirements for sanitation and the prevention of adulteration. This
testing also will play an integral role in the successful
implementation of HACCP in slaughter establishments. In addition, FSIS
is establishing process control performance criteria for fecal
contamination based on the frequency and levels of contamination of
carcasses with E. coli.
As explained below, FSIS is establishing performance criteria to
reflect the prevalence and levels of contamination of E. coli on
carcasses produced nationwide, as determined by FSIS baseline surveys.
The performance criteria and required testing will provide each
slaughter establishment and FSIS with an objective means of verifying
that the establishment is achieving this level of performance and
maintaining it consistently over time. Test results that show an
establishment is meeting or exceeding the criteria provide evidence
that the establishment is maintaining adequate process control for
fecal contamination.
FSIS is purposely using the term performance ``criteria'' rather
than performance ``standard'' in this context because no single set of
test results can demonstrate conclusively that adequate process control
for fecal contamination is or is not being maintained. As explained
below, if test results do not meet the applicable criterion, it raises
questions about the adequacy of the process control. FSIS intends to
consider the establishment's results and corrective actions, together
with other information and inspectional observations, in evaluating
whether a problem exists that requires regulatory action or other
measures to protect consumers and ensure compliance with the law.
Also, as discussed below, although FSIS is proceeding with the
final rule at this time, it is inviting comment on technical aspects of
the process control performance criteria and the required testing. FSIS
requests that comments on the E. coli performance criteria and testing
requirement be focused on the technical aspects of the rule, i.e., the
manner in which the criteria are articulated, the sampling frequency,
and the sampling and testing methodologies.
FSIS intends to update the criteria periodically to ensure that the
criteria adequately reflect an appropriate level of performance with
respect to prevention and removal of fecal contamination and associated
bacteria from livestock and poultry carcasses.
Pathogen Reduction Performance Standards
As proposed, FSIS is adopting pathogen reduction performance
standards using Salmonella as the target organism. The most significant
difference between the proposal and this final rule is that, as
explained above, FSIS is not relying on Salmonella to be a process
control indicator, as well as the target organism for the pathogen
reduction performance standard. Establishments will not be required by
this final rule to test for Salmonella, as had been proposed. Instead,
FSIS will obtain samples from slaughter establishments and
establishments producing raw ground product or fresh pork sausage and
test those samples for Salmonella to ensure that the pathogen reduction
performance standards are being met.
As proposed, FSIS will require that no establishment can have a
prevalence of Salmonella contamination, as a percentage of positive
samples from carcasses and percentage of positive samples from raw
ground product, greater than the baseline prevalence for each raw
product as reflected in the FSIS baseline survey for each species or
other category of raw product. These targets constitute performance
``standards'' rather than performance ``criteria'' because, following
an establishment's implementation of HACCP, FSIS will require that the
establishment meet the standard consistently over time as a condition
of maintaining inspection.
The Salmonella pathogen reduction performance standards are not,
however, lot release standards, and the detection of Salmonella in a
specific lot of raw product will not by itself result in the
condemnation of that lot. The performance standards and FSIS's
enforcement approach, as discussed below, are intended to ensure that
each establishment is consistently achieving an acceptable level of
performance with regard to controlling and reducing harmful bacteria on
raw meat and poultry products.
FSIS considers systematic reduction of pathogenic microorganisms in
raw product to be an essential responsibility of meat and poultry
establishments under the current statutes. As a condition of inspection
and to avoid the production of product that would be deemed legally
adulterated, establishments must utilize available process control
methods and technologies as necessary to achieve applicable pathogen
reduction standards.
Process Control Verification; E. coli Performance Criteria and Testing
Establishments that slaughter livestock and poultry currently have
an obligation to control the slaughter and sanitary dressing process so
that contamination with fecal material and other intestinal contents is
prevented. This means that establishments must maintain sanitary
conditions and use good manufacturing practices to avoid contamination
with visible feces and ingesta and associated bacteria. When such
visible contamination occurs, establishments are expected to detect it
and physically remove it through knife trimming or other approved
removal procedures. The present FSIS verification activity to
demonstrate that this has been accomplished is organoleptic inspection.
FSIS inspectors apply a zero tolerance performance standard for visible
feces and ingesta on dressed carcasses. As a practical matter, however,
additional measures must be taken if inspectors are to assess the
extent to which the invisible bacteria associated with feces and
ingesta may be present on the carcass.
FSIS has concluded, based on its proposal and the comments
received, that the current practice of organoleptic examination by
inspectors and the physical removal of visible contamination by
establishments needs to be supplemented with an establishment-conducted
microbial verification activity. This microbial testing is designed to
verify, for the establishment and FSIS, that the establishment has
controlled its slaughter process with respect to prevention and removal
of fecal material and ingesta and associated bacteria.
Rationale for Using E. coli Tests to Verify Process Control
E. coli testing is more useful than the originally proposed
Salmonella testing in verifying that a slaughter process is under
control. This was expressed in numerous comments on the proposal,
comments generated in FSIS public hearings, and the results of the
scientific and technical conference on the Role of Microbiological
Testing in Verifying Food Safety. The expert panel at that conference
stated:
Microbial testing is an essential element for verifying process
control of raw meat and poultry. A variety of indicators exists, but
the panel concluded that quantitative measurement of Escherichia
coli would be more effective than qualitative Salmonella testing.
When processes are under control for
[[Page 38839]]
E. coli, the potential presence of enteric pathogens will be
minimized.1
\1\ Expert Panel's Summary Report and Recommendations,
Scientific and Technical Conference on Role of Microbiological
Testing in Verifying Food Safety, May 1-2, 1995.
---------------------------------------------------------------------------
The panel compared selection criteria for the choice of an
indicator organism and considered alternative microbial targets such as
E. coli, Enterobacteriaceae, and aerobic plate count, to be used alone
or in combination with Salmonella testing. In reaching its conclusion
that E. coli would be the most effective measure of process control for
enteric pathogens, the panel considered the ideal characteristics of
microbial indicators for the stated purpose. Important characteristics
of E. coli are:
There is a strong association of E. coli with the
presence of enteric pathogens and, in the case of slaughtering, the
presence of fecal contamination.
E. coli occurs at a higher frequency than Salmonella,
and quantitative E. coli testing permits more rapid and more
frequent adjustment of process control.
E. coli has survival and growth characteristics similar
to enteric pathogens, such as E. coli O157:H7 and Salmonella.
Analysis for E. coli poses fewer laboratory safety
issues and testing at the establishment site is more feasible than
such testing with Salmonella.
There is wide acceptance in the international
scientific community of its use as an indicator of the potential
presence of enteric pathogens.
In the panel's view, microbial testing should be used to
demonstrate process control; they concluded that a proximate indicator
for enteric pathogens is needed for demonstrating process control with
respect to fecal contamination. The panel concluded that E. coli would
be the single most effective indicator for this purpose. The panel's
conclusion reinforces previous statements by the NAS that ``at present,
E. coli testing is the best indicator of fecal contamination among the
commonly used fecal-indicator organisms.'' 2 FSIS agrees with
these conclusions.
---------------------------------------------------------------------------
\2\ Subcommittee on Microbiological Criteria, Committee on Food
Protection, Food and Nutrition Board, National Research Council.
1985. ``An Evaluation of the Role of Microbiological Criteria for
Foods and Food Ingredients.'' National Academy Press, Washington,
D.C.
---------------------------------------------------------------------------
If future scientific research identifies another organism or group
of organisms which would prove as effective in measuring process
control for fecal contamination, FSIS would consider appropriate
revisions to the regulations.
Use of Baseline Values to Establish E. coli Performance Criteria
The presence of some microorganisms on raw meat and poultry is
unavoidable and highly variable. The goal of process control in a
slaughter establishment is to minimize initial microbial contamination
of the carcasses, remove harmful microorganisms that nonetheless may be
present, control the proliferation of any remaining microorganisms, and
prevent re-contamination. Process control criteria based on data from
FSIS's nationwide baseline surveys will aid establishments in achieving
this goal and complement the transition to HACCP.
FSIS collects data to develop and maintain a general, ongoing
microbiological profile of carcasses for selected microorganisms of
varying degrees of public health concern, and organisms or groups of
organisms of value as indicators of general hygiene or process control,
and to document changes in the profiles over time. FSIS's Nationwide
Microbiological Baseline Data Collection Programs provide for sampling
over a year's time to account for possible seasonal variations. This
was the approach taken in collecting data from carcasses for all
slaughter classes: steer/heifer, cow/bull, broilers, market hogs, and
turkey. Sampling is designed to represent the vast majority of raw meat
and poultry products produced, in most cases approximately 99% of the
product produced. These programs are nationwide in scope. Enough
samples are taken to enable the Agency to describe the annual
distribution of test results. The number of samples collected also
allows for control of sampling variation and non-sampling errors (such
as missing samples, incomplete data, and inconsistent data). By
contrast, FSIS's Nationwide Surveys provide a snapshot over a specified
period of time less than a year. They involve a large enough number of
samples to ensure a reasonable level of precision for estimates, given
the prevalence of the microorganisms included in the surveys. This was
the approach taken in developing baseline data for other raw meat and
poultry products: ground beef (at inspected establishments and at
retail), ground chicken, ground turkey, and fresh pork sausage.
For the current baselines, carcass samples were taken from fresh,
whole chilled carcasses after slaughter and dressing but before any
further processing took place. Samples were analyzed fresh, not frozen,
to gather more accurate data on numbers of microorganisms, especially
those that are more susceptible to freezing, such as Campylobacter
jejuni/coli. FSIS personnel collected the samples tested in the surveys
using standard Agency procedures for taking aseptic samples from animal
tissues and for ensuring random sample selection.3,4
---------------------------------------------------------------------------
\3\ Food Safety and Inspection Service. 1994. Nationwide Broiler
Chickens Microbiological Baseline Data Collection Program: Broiler
Chicken Sample Collection Procedures, 2/18/94. U.S. Department of
Agriculture, Washington, D.C.
\4\ Food Safety and Inspection Service. 1993. Nationwide Beef
Microbiological Baseline Data Collection Program: Cow/Bull Sample
Collection Procedures, 8/1/93. U.S. Department of Agriculture,
Washington, D.C.
---------------------------------------------------------------------------
Reports of FSIS baseline programs and surveys are issued after
testing results have been compiled and analyzed. Reports have been
completed for cattle, broiler chickens, hogs, ground beef, ground
chicken, and ground turkey. The collection and analysis of samples for
the turkey baseline program and the fresh pork sausage survey will be
underway soon; criteria for turkeys and fresh pork sausage will be
determined upon completion of the sampling and analysis of results.
Establishment of E. coli Performance Criteria to Verify Process Control
Using data from the baseline surveys described in the preceding
section, FSIS has developed animal species-specific, minimum
performance benchmarks, or performance criteria, for E. coli on
carcasses.
As explained above, these criteria are not enforceable regulatory
standards. The E. coli performance criteria are intended to assist
slaughter establishments and FSIS in ensuring that establishments are
meeting their current statutory obligation to prevent and reduce
contamination of carcasses by fecal material, ingesta, and associated
bacteria. The criteria are flexible and are subject to amendment as
FSIS and the industry gain experience with them and accumulate more
data on establishment performance. The criteria are intended
specifically to provide an initial basis upon which slaughter
establishments and FSIS can begin to use microbial testing to evaluate
the adequacy of establishment process controls to prevent feces,
ingesta, and other animal-derived contaminants from contaminating the
tissues intended for use as food.
FSIS has designed the criteria so that establishments meeting them
are achieving results, in terms of E. coli levels, consistent with
those being achieved by a large majority of the slaughter production in
the United States, as reflected in the FSIS baseline
[[Page 38840]]
surveys for each species of livestock and poultry.
The E. coli performance criteria are expressed in terms of a
statistical procedure known as a ``3-class attributes sampling plan''
applied in a moving window. This procedure specifies cutoffs (denoted m
and M, with m m
Marginal--result > m and M
Unacceptable--result > M
Under this approach, m and M are defined in relation to the
distribution of E. coli results for each slaughter class. The Agency
has used as the starting point for establishing the cutoff for m the
80th percentile of current industry wide performance, in terms of E.
coli levels, for each slaughter class. The starting point for
establishing M is the 98th percentile of industry performance. Thus, if
the criterion for any species were set precisely at those percentiles,
a set of test results indicating performance in the 80th to 98th
percentile range, according to FSIS's Nationwide Microbiological
Baseline Data Collection Program results, would be deemed ``marginal,''
and, as discussed below, would raise a question about the adequacy of
the establishment's process control. Expressed in another way,
``marginal'' results would be within the worst 20% of overall industry
performance in terms of E. coli counts. Similarly, results worse than
the 98th percentile (M) are within the worst 2% of overall industry
performance. Any single result exceeding M is, therefore, deemed
``unacceptable.''
Table 1.--Distribution of E. coli by Slaughter Class
----------------------------------------------------------------------------------------------------------------
Percentile Steer/heifer Cow/bull Broilers Hogs
----------------------------------------------------------------------------------------------------------------
50th (median)................... Negative*......... Negative*......... 29 cfu/ml......... Negative*
80th (m)........................ Negative*......... Negative*......... 80................ 10 cfu/cm \2\
90th............................ Negative*......... 10 cfu/cm \2\..... 180............... 150
95th............................ 10 cfu/cm \2\..... 40................ 360............... 880
98th (M)........................ 80................ 300............... 1100.............. 6,800
99th............................ 290............... 2200.............. 3300.............. 33,000
----------------------------------------------------------------------------------------------------------------
* Negative by the method used in the baselines which had a minimum detectable level of 5 cfu/cm \2\ of carcass
surface area.
Table 1 shows the level at which E. coli has been found on
carcasses, by slaughter class as a percent of all such product. For
example, the data show that 80% of broilers tested at or below 80
colony forming units per milliliter (cfu/ml), while 90% tested at or
below 180 cfu/ml. More detailed descriptions of the distribution of
numbers of E. coli found per carcass species are provided in FSIS's
baseline reports.
To make the criteria as simple and easy to use as possible,
consistent with the accepted laboratory practice of diluting samples
successively by factors of 10 to obtain bacteria counts, FSIS has
elected to express the criteria in terms of powers of 10 (i.e., 10,
100, 1000, etc.). As shown in Table 2, this results in m and M being
the closest power of 10 to the actual numbers estimated for the 80th
and 98th percentiles from the baseline data.
Because the Agency's baseline survey work on turkeys is still
underway, no E. coli criterion is being established at this time for
that slaughter class.
Table 2.--m and M Values for E. coli Performance Criteria
------------------------------------------------------------------------
Slaughter class m M
------------------------------------------------------------------------
Steer/Heifer........................ (1).................. 100
Cow/Bull............................ (1).................. 100
Broiler............................. 100.................. 1000
Hogs................................ 10................... 10,000
------------------------------------------------------------------------
\1\ Negative.
It should be noted that ``negative,'' in this context, is defined
by the sensitivity of the method used in the Baseline Surveys, which
was 5 cfu/cm2 of carcass surface area for cattle and hogs.
FSIS is requiring the use of an analytic method approved by the
Association of Official Analytic Chemists or any method validated by a
scientific body in collaborative trials against the three tube Most
Probable Number (MPN) method and agreeing with the 95 percent upper and
lower confidence limit of the appropriate MPN index.
FSIS has concluded that, at some point, the number of samples
testing in the marginal range raises a significant question about the
adequacy of an establishment's process control, and has defined that
point for purposes of these criteria as more than 3 results above m
within any consecutive 13 samples tested. This point was established
based on the following analysis.
There occasionally will be test results that exceed the acceptable
level, m, because of variations or aberrations in establishment
performance, sampling, etc., that do not reflect the state of overall
process control. FSIS believes that the performance criteria and
approach to evaluating test results should avoid raising a significant
process control question on the basis of chance results, but should be
sensitive enough to provide a reasonably high likelihood of detecting
performance that falls significantly short of the national baseline
levels. FSIS has decided that it is appropriate to evaluate test
results in a manner that ensures that there is an 80% probability that
establishments actually operating at the acceptable performance level
will achieve results that are deemed to satisfy the criteria. This is
the same statistical approach FSIS took in its proposed approach to
evaluating an establishment's Salmonella test results, using the moving
window approach to evaluating process control verification tests (see
pages 6798-6805 of the Pathogen Reduction/HACCP proposal).
Using this approach, it can be predicted statistically that
slaughter establishments that are operating at the acceptable
performance level reflected by m will, with an 80% probability, have
three or fewer results above m (denoted as c) within every 13 samples
tested (denoted as n). FSIS will require slaughter establishments to
record and evaluate E. coli results in a ``moving window'' of 13
consecutive results. A moving window provides a continuous picture of
establishment performance and is the preferred statistical approach for
assessing ongoing processes (as opposed to sampling specific lots of
product for contaminants). Thus, the presence of more than three
marginal results within any 13 consecutive samples, or the ``window,''
will be indicative of an operation failing to meet the criteria.
Use of a different probability level, such as a 70% or 90%
probability of getting acceptable test results if establishments are
operating at the specified level would result in different values for c
and n (namely, c=3 and
[[Page 38841]]
n=15 using the 70% probability level, and c=3 and n=10 using the 90%
probability level). Using 70% as the statistical criterion for setting
c and n would result in too many chance failures of the criteria, while
using 90% would make it too difficult to detect potential process
control problems. It is the judgment of the Agency that use of the 80%
probability level strikes a reasonable balance.
In summary, if the results of one test are above M, or if more than
3 of 13 test results are above m, a significant question is raised as
to whether the establishment is maintaining adequate process control
and will trigger further review of establishment process control. FSIS
stresses again that these E. coli criteria are guidelines, not
regulatory standards. Ideally, each establishment will develop its own
equally or more effective criteria for process control based on its own
data and/or industry-developed benchmarks. FSIS encourages
establishments, in the context of their HACCP plans, to apply their
own, establishment-specific criteria to ensure process control.
FSIS also is inviting comment on the approach it has taken to
expressing its E. coli performance criteria for verifying process
control. FSIS recognizes that there is more than one possible approach
and welcomes comments and suggestions.
Sampling Frequency for E. coli Testing
FSIS has chosen to use production volume as the basis for
determining the frequency at which establishments will conduct testing
for E. coli. In the proposed rule, FSIS proposed to require all
slaughter establishments and establishments producing ground meat and
poultry, regardless of size or volume, to conduct one test for
Salmonella each day. This was based on the premise that verifying that
a process is ``in control'' is more a function of specific
establishment characteristics than the amount of product being
produced. However, commenters suggested and FSIS recognizes that there
may be striking differences in the ways in which high and low volume
establishments operate, which can influence the ability of the
establishment to keep processes in control. High volume establishments
may receive animals for slaughter from a number of different sources
for each day's production; there may be several shifts, and production
personnel are often more transient; there may be multiple supervisors;
and there may be much greater complexity in the overall slaughter
process. In contrast, a low volume establishment will have a smaller
and possibly more stable work-force, often supervised by an owner-
operator, and may employ relatively simple procedures that are
performed consistently over time. This does not negate the need in low
volume establishments for microbial verification of a HACCP plan;
however, under these circumstances it may not be as essential for very
low volume establishments to undertake daily microbial testing, as
initially proposed. By adopting a volume-based system, the testing
frequency will, by definition, be highest in large establishments
producing the most product, while the number of tests will be minimized
in smaller establishments.
The majority of commenters who opposed daily testing stated that
such a testing requirement would place an unfair cost burden and have a
negative financial impact on small establishments, as it would require
the same expenditure for testing by establishments that slaughtered one
or two animals per day as those slaughtering several thousand daily. It
was also noted that there is a public health consequence to the
proposed approach. If a process control problem detectable by microbial
testing existed in a high volume establishment that tested only once a
day, a great deal more potentially contaminated product would be
produced and distributed before enough microbial tests were performed
to show the problem existed than would be the case in a small volume
establishment. These issues are addressed by the switch to a volume-
based testing system.
There is no single method for determining the frequency of
microbial testing within a volume-based testing system that will be
equally effective in all establishments. Testing frequencies are
ideally determined on an establishment-by-establishment basis, taking
into account a number of variables, including differences in sources of
raw materials, the type and nature of the process, and the consistency
of microbial test results over time. Nonetheless, for both public
health and process control verification reasons, FSIS considers it
necessary and reasonable to require a minimum frequency of testing
sufficient to result in completion of at least one E. coli test window
(13 samples) per day in the highest volume establishments for each
species. This will provide a daily set of results adequate to verify
process control in the highest volume establishments. Accumulation of
results over a longer period of time will be an acceptable basis for
verifying process control in lower volume establishments.
Based on these principles and conclusions, the required minimum
frequencies for E. coli testing for each slaughter species are as shown
in Table 3.
Table 3.--E. coli Testing Frequencies
------------------------------------------------------------------------
------------------------------------------------------------------------
Cattle............................ 1 test per 300 carcasses.
Swine............................. 1 test per 1,000 carcasses.
Chicken........................... 1 test per 22,000 carcasses.
Turkey............................ 1 test per 3,000 carcasses.
------------------------------------------------------------------------
The frequencies were derived by first rank-ordering all slaughter
establishments by species based on total annual production. This
ranking, which was based on data from FY 1993 and FY 1994, revealed
that establishment production volumes vary widely and that there are
appreciable differences in the concentration of business among the
industries. In cattle slaughter, 12 of 912 establishments accounted for
over 42% of production, with the smallest of these slaughtering about
one million head annually. On the small volume end, 620 establishments
slaughtered fewer than 1000 head annually and together accounted for
about one-half of one percent (0.5%) of national slaughter production.
By contrast, there are ten or fewer very low volume establishments
slaughtering chickens, and production is spread more evenly over the
240 establishments on the FSIS FY 1994 inventory of establishments. 42
of 240 slaughter establishments accounted for 40% of production.
FSIS has selected sampling frequencies so that in the subgroup of
establishments accounting for 99% of total production for each species,
the 5% of establishments with the highest production volume would each
have to conduct a minimum of 13 E. coli tests, or at least one complete
test window, each day. In addition, with these frequencies, 90% of all
cattle, 94% of all swine, 99% of all chicken, and 99% of all turkeys
will be slaughtered in establishments conducting a minimum of one E.
coli test per day.
The above frequencies notwithstanding, FSIS has concluded that all
establishments must conduct sampling at a frequency of at least once
per week to provide a minimum, adequate basis for process control
verification using E. coli testing. However, establishments with very
low volumes, annually slaughtering no more than 6,000 cattle, 20,000
swine, or a combination of such livestock not to exceed a total of
20,000 with a maximum of 6,000 cattle, or 440,000 chickens or 60,000
turkeys (or a combination of such poultry not to
[[Page 38842]]
exceed a total of 440,000, with a maximum of 60,000 turkeys), will be
required to sample once per week only until a sampling window that
verifies process control has been completed and the results indicate
that the slaughter process is under control. Establishments
slaughtering more than one species would sample the species slaughtered
in greater number. Once these criteria have been met, these
establishments will be required to complete a new sampling window that
verifies process control only once each year, in the 3-month period of
June through August, or when a change has been made in the slaughter
process or personnel.
The Agency is permitting these very low volume establishments to
conduct as few as 13 tests per year, in part because of their
relatively simple and stable production environments. The slaughtering
equipment in many cases may consist merely of a skinning bed, hoist,
bonesaw (for poultry establishments, a small scalding tank, small
defeathering device), and/or several types of knives. There are fewer
personnel and there is less turnover in general. Of course, these
establishments do change. Should there be any substantial changes in
installed equipment or personnel, a new sampling window must be
completed. These establishments must also complete a successful
sampling window annually, regardless of whether there have been any
substantial changes, in order to verify that the performance criteria
continue to be met. Many small, nonsubstantial changes, in aggregate,
may have an impact on process control. This annual testing must be
conducted during the summer months of June through August, when there
is a seasonal peak in the occurrence of foodborne diseases attributable
to the major bacteria pathogens. Published and summary reports of
Centers for Disease Control and Prevention (CDC) outbreak and sporadic
disease surveillance have documented this seasonal trend for Salmonella
spp.5,6 and for Campylobacter jejuni/coli.7 Although national
surveillance for E. coli O157:H7 is relatively new and data are not
available, Washington State surveillance has documented a similar
seasonal trend for that pathogen.8 The proposed requirement of one
Salmonella sample per day would have assured testing during this
period.
---------------------------------------------------------------------------
\5\ Bean, N.H. and P.M. Griffin. 1990. Foodborne Disease
Outbreaks in the United States, 1973-1987. J. Food Protection.
53:804-817.
\6\ Centers for Disease Control and Prevention. 1995. Salmonella
Surveillance, Annual Tabulation Summary, 1993-1994. U.S. Department
of Health and Human Services, Public Health Service, Atlanta, GA.
\7\ Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K.
Wachsmuth. 1988. Campylobacter Isolates in the United States, 1982-
1986. MMWR. 37 (SS-2):1-13.
\8\ Ostroff, S.M., J.M. Kobayshi, and J.H. Lewis. 1989.
Infections with Escherichia coli O157:H7 in Washington State. JAMA
262(3):355-359.
---------------------------------------------------------------------------
Therefore, the regulation specifies that when sampling and testing
is done annually, instead of continually, it be conducted within a 13-
sample window between June and August each year. This annual sampling
must occur during this period, regardless of when other sampling
windows may have occurred. Completing a successful sampling window
annually will verify that the slaughter process continues to meet the
performance criteria or will point to the need to reassess and revise
the HACCP plan.
Another reason for this approach to very low volume establishment
testing is that the total risk of exposure to enteric pathogens from
product produced at such establishments is assumed to be small and
roughly proportional to the amount of product produced. Eighty-one
percent of establishments slaughtering cattle would meet this low
volume criteria; however, these establishments together supply only
1.5% of the total national production. Further, establishments meeting
these low volume criteria constitute 86% of all swine establishments,
accounting for 1.3% of overall production. Thirteen percent of all
establishments slaughtering chicken would meet this low volume
requirement; however, these establishments together supply only 0.05%
of total national production. Similarly, 42% of all turkey
establishments are low volume establishments accounting for only 0.1%
of production.
FSIS intends that establishments operating under a validated HACCP
system use microbial testing in their process control verification
activities, and is requiring that slaughter establishments under HACCP
use E. coli testing for that purpose. As noted above, however, the
Agency acknowledges that there may be other, perhaps equally effective
alternative approaches for determining sampling frequencies for E. coli
testing for process control verification in slaughter establishments
with a carefully designed HACCP system. The Agency is aware that
comparable models have been developed in the context of quality
assurance programs. These models, however, are part of programs that,
like HACCP, involve more than mere statistical sampling, and usually
are much more oriented to specific establishment/process/product
combinations. Such models cannot easily be transferred to a nationwide
collection of producers of a product, each with unique characteristics.
The frequency rule established in this regulation recognizes the
relevance of establishment characteristics in the area of verification,
as in other facets of the HACCP plan, and therefore allows slaughter
establishments to alter frequencies as appropriate for their
circumstances when they institute HACCP. That is, slaughter
establishments under HACCP may use a sampling frequency other than that
provided for in the regulation, if the alternative sampling frequency
is an integral part of the establishment's HACCP verification
procedures and if FSIS does not determine, and notify the establishment
in writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
Establishments electing to institute HACCP prior to the dates required
may use an alternative sampling frequency upon presentation to FSIS of
data demonstrating the adequacy of that sampling frequency for
verification of process controls to prevent fecal contamination.
Establishments currently using an alternative E. coli sampling
frequency for process control purposes, but not yet under a HACCP plan,
will have to test at the frequencies specified in the regulation unless
they have been granted an exemption by FSIS. However, after
consideration of comments received on this rule that may result in
protocol changes affecting all establishments, and publication of a
Federal Register document addressing the comments, FSIS will consider
requests for such exemptions on a case-by-case basis, upon the timely
submission to FSIS of data demonstrating the adequacy of the
alternative frequency for verification of process controls to prevent
fecal contamination.
Sampling and Analytical Methodology
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control. Such
consistency also will facilitate FSIS verification activities. As
discussed below, the performance criteria are applicable to each type
of carcass, industry-wide, based on FSIS's national baseline survey
data. Because each establishment's performance is measured against the
[[Page 38843]]
performance of all surveyed establishments producing the same kind of
product, it is essential that all like establishments adhere to the
same basic sampling and analysis requirements.
Each establishment is responsible for having written sampling
procedures that are to be followed by a designated employee or agent.
Samples are to be taken randomly at the required frequency. If an
establishment runs more than one line, the lines from which samples are
to be taken also are to be selected randomly. Samples from livestock
carcasses are to be collected by a nondestructive method that requires
a commercially available sampling sponge to be rubbed on the carcass
surface after the carcass has been chilled in the cooler for 12 hours
or more after slaughter. Establishments are required to take samples
from three sites on each carcass. These three sites are the same ones
that were used by FSIS when conducting the baseline studies for cattle
and swine. On cattle carcasses, establishments will take samples from
the flank, brisket, and rump areas; on swine carcasses, samples will be
taken from the ham, ``belly,'' and jowl areas. The sponge is to be
placed afterwards in an amount of buffer to transfer any E. coli to a
solution, which then is analyzed for E. coli. Samples from poultry
carcasses will be collected by taking whole birds from the end of the
chilling process, after the drip line, and rinsing them in an amount of
buffer appropriate for the type of bird being tested.
The sponge sampling technique to be used on swine and cattle
carcasses has been subject to many studies. A sponge technique has been
reported by Dorsa et al.9 and others, including Gill et
al.10, as an acceptable means of in-plant sampling to detect fecal
contamination.
---------------------------------------------------------------------------
\9\ Dorsa, W.J., C.N. Cutter, G.R. Siragusa. 1996. Evaluation of
Six Sampling Methods for Recovery of Bacteria from Beef Carcass
Surfaces. Letters in Applied Microbial. 22:39-41.
\10\ Gill, C.O. J.C. McGinnis, M. Badoni. 1996. Assessment of
the Hygienic Characteristics of a Beef Carcass Dressing Process. J.
Food Protection 59(2):136-140.
---------------------------------------------------------------------------
The excision method for sample collection would not be acceptable
for routine sampling to verify process control because this defaces the
carcass, and some establishments would be required to sample 13
carcasses per day. Instead, for both cattle and swine carcasses, the
sponge method requires that 100 cm2 at each of the three sites be
sampled by swabbing, for a total area of 300 cm2 compared to the
60 cm2 area of excised tissue analyzed in the baseline studies for
cattle and swine. The results would still be reported on a square
centimeter basis. The larger sampling area for the swabbing method is
expected to provide results comparable to the excision technique.
The exact correlation between the sponging technique and the
excision technique used during the baseline surveys is being assessed
by ARS. Currently available results indicate a high degree of
correlation between the two. These studies and any other new microbial
sampling data will be made available to the public. This sponging
technique will also be used in the FSIS Salmonella program. FSIS is
continuing to improve the sponging technique and welcomes comments.
FSIS considered providing that samples be taken from only one site
on livestock carcasses: from the brisket on cattle and the belly area
on swine. Sampling from one site has advantages. It would be less labor
intensive. Further, sampling from one site might pose fewer worker
safety problems than sampling from three sites because, for the latter
option, a ladder generally is needed to reach the rumps of the
suspended carcasses. Nonetheless, FSIS has determined that slaughter
establishments must take samples from the three sites from which
samples were drawn during the baseline studies or programs in the
absence of data demonstrating that one-site sampling also will provide
results comparable to the baseline survey data. The Agency invites
comments on its requirement that establishments collect samples from
the specified three sites on swine and cattle carcasses and the
adequacy of alternative sampling approaches.
Samples may be analyzed in either the establishment's own
laboratory or a commercial laboratory. Samples must be analyzed by a
quantitative method of analysis for E. coli. The method must be
approved by the Association of Official Analytic Chemists or validated
by a scientific body in collaborative trials against the three tube
most probable number (MPN) method and agreeing with the 95 percent
upper and lower confidence limit of the appropriate MPN index.
FSIS has developed and is publishing as an appendix to the document
guidelines that provide additional, detailed information on how best to
sample, test, record, and interpret results for E. coli under this
regulation. FSIS invites comment on these guidelines.
Recordkeeping
Results of each test must be recorded, in terms of colony forming
units per milliliter (cfu/ml) for poultry carcasses or per square
centimeter (cfu/cm2) for livestock carcasses, on a process control
chart or table that permits evaluation of the test results in relation
to preceding tests in accordance with the applicable criteria. These
records must be maintained at the establishment for 12 months and must
be made available to Inspection Program employees on request.
Inspectors will monitor results over time, to verify effective and
consistent process control.
Use of E. Coli Test Results by Establishments
As discussed in preceding sections, establishments slaughtering
livestock or poultry are required to use E. coli testing and evaluation
of the results to verify the adequacy of their process controls for
fecal contamination. Any test result in the marginal range (above m)
indicates to the establishment that there is a potential problem in its
processing control that may require attention. If the number of test
results above m exceeds the specific number allowed, c (3, for all
species), in the specific number of consecutive tests in the moving
window, n (13 for all species), the establishment has failed to meet
the performance criteria, and a significant question has been raised
about the adequacy of the establishment's process controls for fecal
contamination. Review of the process by the establishment and necessary
corrective actions are strongly suggested.
Results above the upper value M are unacceptable and should trigger
immediate establishment review of slaughter process controls to
discover the cause of the failure and to prevent recurrence, and, if a
product has been affected, to consider the status and proper
disposition of the product as the circumstances dictate.
Use of E. coli Test Results by FSIS
FSIS personnel, like establishment personnel, will use the E. coli
test results to help assess how well the establishment is controlling
its slaughter and dressing processes. FSIS will compare establishment
test results to the applicable E. coli performance criterion. A single
failure to meet the criterion does not by itself demonstrate a lack of
process control or product adulteration, but it will trigger greater
inspection activity to establish that all applicable sanitation and
process control requirements are being met and product is not being
adulterated. Inspectors may make additional visual inspections of
products and/or equipment and facilities, collect samples for FSIS
laboratory analysis, and retain or condemn product, as appropriate. In
addition, Sanitation
[[Page 38844]]
SOP's and HACCP records will be reviewed, as appropriate. Failure to
meet the criterion may also result in the establishment being selected
for intensified Agency testing for Salmonella under the pathogen
reduction performance standard sampling program; and, if the
establishment produced ground beef, its product could be targeted in
the E. coli. O157:H7 ground beef testing program.
The E. coli test results will be used by FSIS, along with all other
relevant data and observations, including past establishment
performance, to determine whether a slaughter establishment is meeting
its process control responsibilities. Repeated failures to meet the
criterion would lend support to a finding that the establishment's
process controls are inadequate. Failure to maintain adequate process
control will result in suspension and withdrawal of inspection, as
appropriate. Such actions will be made in accordance with rules of
practice that will be adopted for those proceedings.
After a slaughter establishment implements HACCP, the E. coli
testing program will continue as a HACCP verification activity.
Isolated or occasional failures to meet the E. coli performance
criterion may indicate that establishment personnel need to take
corrective actions spelled out in their HACCP plan. Repeated failures
to meet the criterion will result in FSIS focusing its verification
oversight on relevant CCP's, which could lead to the need for HACCP
plan reassessment by the establishment, as well as other inspection and
compliance related activities that may be appropriate, as discussed
above.
Implementation Timetable
Six months from this publication date, establishments that
slaughter livestock or poultry will be required to begin sampling and
testing for E. coli at the volume-based rates described above. From
that time, those establishments that do not test or fail to keep
records of results as prescribed by the regulation will be subject to
withdrawal of inspection in accord with the procedures set forth in 9
CFR 335.13 or 381.234. After another six months, i.e., 12 months after
publication of this final rule, after establishments have had an
opportunity to gain experience in conducting this testing, recording
the results, and using the data to verify and improve process control,
FSIS personnel will incorporate the review of establishment E. coli
test results into its inspection routine.
In considering the timeframe for implementing the E. coli testing
requirement, FSIS has taken into account the practicality of initiating
such testing in a large number of establishments, the potential utility
of the resulting data to establishments as they prepare for HACCP
implementation, and the added consumer protection of having
establishments, particularly those scheduled to implement HACCP towards
the end of the implementation timetable, initiating testing and
evaluating results against the process control performance criteria.
FSIS is aware that many establishments, especially large ones, already
use microbial testing as a means of verifying their process control
systems; many may already be testing for generic E. coli. Some of those
establishments may already have HACCP plans in place as well.
Establishments performing microbiological testing and already working
under HACCP plans have found that such testing is an important element
in conducting a hazard analysis, validating HACCP plans, and verifying
the ongoing effectiveness of HACCP systems.
For establishments that are not already performing microbiological
testing and not operating under HACCP plans, the data will be valuable
in revealing how well or poorly their slaughter process is performing
in microbiological terms, when compared against the microbial
characteristics of a large portion of national production, and will
provide an indication of whether immediate actions are required to
prevent product adulteration and protect food safety. In addition, such
data, when accumulated over a period of time, will contribute to the
conduct of hazard analyses and selection of process control measures.
Collection of these data will provide benchmarks for each establishment
as it begins to understand the food safety implications of its
processes and how to improve them.
In the meantime, FSIS personnel, using the performance criteria as
benchmarks for overall industry performance in terms of the number of
E. coli organisms found on carcasses at a specific point in the
slaughter process, will be able to review establishment data and other
evidence to determine if each establishment is achieving an acceptable
level of performance.
Request for Comments
The Agency is soliciting additional comment and information on a
number of technical issues concerning the protocols for E. coli
testing, and on that basis will consider adjusting those protocols
prior to the effective date. In particular, two concerns have been
raised on the issue of the rule's statistical framework: 1) the
representativeness of the proposed sample collection, and 2) the levels
and distribution of E. coli on carcasses and the ways in which these
levels affect the utility of the proposed testing protocol.
Because poultry slaughter establishments must collect samples with
a whole bird rinse, the representativeness of the sampling site is not
an issue; the entire bird is being sampled. FSIS used this technique
when collecting baseline data and therefore, establishment data should
be comparable to baseline survey data. Further, greater than 99 percent
of broiler carcasses in the national baseline survey had detectable E.
coli. Generic E. coli testing data therefore clearly will be useful to
poultry slaughter establishments as they initiate HACCP and begin to
verify the associated process control procedures. E. coli testing
procedures for poultry required by this rule comport well with the
available scientific data and discussions held as part of the public
comment process.
More difficult issues arose in developing E. coli sampling
procedures for cattle and swine carcasses. Part of the concern, as
discussed, stems from the fact that a whole carcass rinse is impossible
with a large carcass, and thus it is necessary to select specific
sampling sites. Selections of sites, in turn, may influence results,
particularly if generic E. coli is not randomly distributed on the
carcass. Site selection may also influence the usefulness of resultant
data. For example, the appropriate response to an elevated generic E.
coli level on the rump of a beef carcass may be different from the
appropriate response to an elevated generic E. coli level at the site
of the midline incision. The Agency wants comments on the relative
merits of a one-site versus three-site sampling approach.
Another concern revolves around the correlation between non-
destructive and destructive sampling. The baseline surveys used
destructive sampling, that is, culturing of tissue excised from the
carcass. FSIS agrees with commenters that reasonable results can be
obtained with a non-destructive swabbing technique for sampling.
Preliminary data indicate that results obtained with a destructive and
non-destructive sampling are comparable, although studies continue.
Another concern arises from the statistical basis for E. coli
testing. In
[[Page 38845]]
particular, the levels of generic E. coli on cattle carcasses in the
national baseline survey were low, with the majority of carcasses
having no detectable E. coli. This could raise questions about the
utility of the E. coli test results in evaluating process controls in
establishments slaughtering cattle.
The principal utility of process control testing stems from the
availability to a establishment of results over time from that
establishment. The tracking of trends and identification of anomalous
results permits isolation and correction of problem areas that might
otherwise go unnoticed. FSIS has concluded that testing for generic E.
coli is the appropriate and necessary means by which meat and poultry
slaughter establishments must evaluate and verify the adequacy of their
process controls. FSIS considers systematic measures to prevent and
remove fecal contamination and associated bacteria, coupled with
microbial testing to verify effectiveness, to be the state of the art
in slaughter establishment sanitation. Microbial testing for bacteria
that are good indicators of fecal contamination and the regular
availability of test results will help to focus establishments on the
effectiveness of their measures for preventing and removing fecal
contamination and will provide information establishments can use in
maintaining adequate process control. FSIS reached this conclusion upon
its review of written comments received on the proposal and comments
made at the scientific conferences and public meetings, as well as
available scientific data, and has retabulated and reassessed its
baseline data as it applies to the E. coli testing in the rule.
In the first reassessment, it was determined that the lower levels
and more frequent negative test results of E. coli found on livestock,
particularly steers and heifers, as compared to poultry in the baseline
survey data does not undercut the utility of the E. coli criteria which
are also based on the baseline survey data. FSIS tested the performance
criteria in this rule by applying it to plant-specific test results
obtained during the baseline surveys. FSIS looked at data from
establishments for which at least 20 test results were available, and
listed the results by collection date much as would be done by the
establishments under the rule. The Agency found that about half of the
establishments in each of the livestock slaughter categories fully met
the criteria, which suggests that those establishments have good
process controls for prevention of fecal contamination. The Agency also
found that many establishments failed to meet the applicable E. coli
criterion (any result above M, or more than 3 results above m out of
the most recent 13 test results): 2 out of 30 steer/heifer
establishments, 10 out of 34 cow/bull establishments, and 11 out of 31
market hog establishments failed to meet the criterion at least 20% of
the time, suggesting that a significant number of livestock slaughter
establishments should review and make adjustments to their process
controls.
The Agency also made an assessment of whether the baselines show
true differences in E. coli results among establishments that slaughter
the same categories of livestock. The Agency did a statistical analysis
of a hypothesis: percents positive are equal among establishments
slaughtering the same category of livestock. The analysis involved
comparing E. coli test results of pairs of establishments. This
comparison showed wide ranges in the percents positive between
establishments albeit smaller differences among steer/heifer
establishments. The percents positive ranged between 0.0 to 27.1 for
steer/heifer establishments, 0.0 to 45.2 for cow/bull establishments,
and 2.2 to 97.1 for market hog establishments. The hypothesis,
therefore, was rejected because the data showed significant differences
in the prevalence of E. coli on carcasses of animals found in
establishments slaughtering the same categories of livestock.
The retabulated data developed for these two analyses are available
for viewing in the FSIS Docket Room (See ADDRESSES) as part of the
administrative record of this rulemaking.
FSIS invites comments on the statistical frameworks it has used for
E. coli testing and performance criteria. The Agency is open to the
possibility that it might further improve its testing protocols prior
to the implementation date, and is seeking additional relevant
scientific and economic data. In particular, in light of the concerns
noted above, FSIS is seeking additional data relating to the
distribution of generic E. coli on cattle and swine carcasses,
differences in E. coli levels within and between establishments, and
the appropriateness of various data sets for establishing the proposed
80th and 98th percentile national criteria for generic E. coli levels
on cattle and swine carcasses.
FSIS also requests comments and information addressing the
following questions:
Are there alternative, equally or more effective risk based
microbial sampling protocols that could be used for process control
verification by establishments that slaughter cattle or swine?
Are there more appropriate anatomical sites for microbial
testing than those adopted?
Are there alternative sampling frequencies that would elicit
results more indicative of process control performance?
How could the proposed testing protocol be revised to better
account for differing establishment characteristics and how can FSIS
minimize the cost to establishments of E. coli testing without
sacrificing testing effectiveness?
Are there worker safety concerns regarding sampling from
difficult to reach carcass sites and, if so, how might they be
mitigated?
Given that testing is based on production volume, are there
effective approaches other than requiring very small establishments
to conduct a minimal amount of testing during certain months of the
year?
FSIS is aware that some individuals, companies, and trade groups
have conducted research and have data on the various carcass sampling
sites and associated levels of bacteria at these sites (carcass
mapping). FSIS welcomes any information concerning E. coli and other
microorganisms at various sites on carcasses.
FSIS has opted to establish performance criteria based on the
levels and distribution of E. coli for the various slaughter classes.
Some individuals and companies may have established their own criteria
for process control verification. FSIS welcomes information on the
rationales, sampling plans and protocols on which any such criteria are
based, as well as data (or data summaries) collected under such
protocols.
FSIS welcomes any new or unpublished research results or
information that exists concerning the relationship between the
presence of generic E. coli and the presence of other pathogenic
microorganisms on cattle and swine carcasses.
FSIS specifically invites establishments currently conducting
generic E. coli testing for process control verification to submit data
regarding their costs, including labor and training costs, as well as
testing costs per unit. FSIS will use this data to assess the merits of
alternative testing protocols.
FSIS invites comments on how, and the extent to which, it should
summarize and make available to the industry and public E. coli testing
data made available to it under these regulations. Reports on the
collective experiences of establishments with various characteristics
could be useful to the industry, the Agency, and the public at large.
In light of these issues, in particular those reflecting continuing
concerns
[[Page 38846]]
about the applicability of the national criteria to all affected
establishments, the frequency and other parts of the testing protocols,
and the statistical utility of the establishment's test results as a
measure of process control, FSIS plans to conduct two public
conferences. The first conference is planned to be held approximately
45 days into the 60 day comment period following publication of this
rule. This public conference will be led by a panel of scientists from
FSIS and other government agencies who will listen to testimony and
review comments received on these technical issues and share their
observations and opinions. FSIS will consider their input along with
all comments received as the basis for any necessary technical
amendments, which will be completed at least 30 days before the
implementation date. The second public conference is tentatively
planned for approximately 9 months following publication of this final
rule. This conference would be an opportunity for the industry and
others to discuss with FSIS new information based on about 3 months of
testing experience that may bear on these same issues and might allow
for further adjustments of protocols before FSIS inspectors are tasked,
about three months later, with comparing test results to the national
criteria as part of their inspection routine. FSIS will publish
further, more detailed notice of these conferences in future issues of
the Federal Register.
Pathogen Reduction Performance Standards
The pathogen reduction performance standards for Salmonella FSIS is
establishing in this final rule complement the process control
performance criteria for fecal contamination and E. coli testing.
The likelihood of product contamination by Salmonella is affected
by factors in addition to the incidence or degree of fecal
contamination, including the condition of incoming animals and cross
contamination among carcasses during the slaughter process and further
processing. Under HACCP, establishments will be expected to establish
controls wherever practicable to address and reduce the risk of
contamination with harmful bacteria. The pathogen reduction performance
standards FSIS is establishing for Salmonella are an important step
toward enabling FSIS and the establishment to verify the aggregate
effectiveness of an establishment's HACCP controls in reducing harmful
bacteria.
Rationale for Selecting Salmonella
In the future, FSIS may develop pathogen reduction performance
standards targeting a number of pathogens. Initially, however, FSIS has
developed pathogen reduction performance standards only for one--
Salmonella. Salmonella is an enteric pathogen, which as a group cause
most preventable illnesses associated with meat and poultry.
FSIS has selected Salmonella because: (1) it is the most common
bacterial cause of foodborne illness; (2) FSIS baseline data show that
Salmonella colonizes a variety of mammals and birds, and occurs at
frequencies which permit changes to be detected and monitored; (3)
current methodologies can recover Salmonella from a variety of meat and
poultry products; and (4) intervention strategies aimed at reducing
fecal contamination and other sources of Salmonella on raw product
should be effective against other pathogens.
Basis for Performance Standards and Plans for Future Adjustments
The pathogen reduction performance standards for Salmonella are
based on the current prevalence of Salmonella, as determined from
FSIS's baseline surveys. Current prevalence percentages based on the
data from these surveys are listed in Table 4 and in the regulations
(new Secs. 310.25(c)(3)(ii) and 381.94(c)(3)(ii)) under the column
headed ``Performance Standard.'' This is the performance standard that
establishments must achieve, not on a lot-by-lot basis, but
consistently over a period of time through appropriate and well-
executed process control.
This is the same approach to setting the ``interim targets for
pathogen reduction'' that FSIS proposed in its Pathogen Reduction/HACCP
proposal. As explained in the preamble to that proposal, basing the
performance standard on the national baseline prevalence means that
some establishments are already meeting or exceeding the standard,
while other establishments are not. FSIS believes that it is feasible
for all establishments to meet or exceed the current baseline
prevalence of contamination with Salmonella, through careful process
control to prevent contamination and incorporation of readily available
food safety technologies and procedures to remove contamination. The
feasibility of achieving this standard is demonstrated by the fact that
many establishments are already doing so.
The Agency believes that most establishments maintaining sanitary
conditions under their Sanitation SOP's and operating under validated
HACCP plans, as provided for elsewhere in this regulation, will be able
to meet the pathogen reduction performance standards without major new
costs. For example, HACCP plans for slaughter establishments are
expected to address the condition of incoming animals, and may provide
for more systematic control of relevant processes or interventions,
such as the cleaning of animals or carcasses before evisceration. HACCP
systems should, therefore, result in many establishments improving the
microbial profile of their finished raw products.
Slaughter establishments concerned that they might not meet the
pathogen reduction performance standard have available a wide range of
technologies shown to reduce the levels of pathogens that may be on the
surface of carcasses. As discussed in some detail in the proposed rule,
antimicrobial treatments normally include washes or sprays that use
either hot water or a solution of water and a substance approved by
FSIS for that use. Such substances include acids (lactic, acetic, and
citric), trisodium phosphate (TSP), and chlorine. In addition, FSIS has
recently established that spray-vacuum devices that apply pressurized
steam or hot water to beef carcasses and immediately vacuum it up also
are effective in reducing bacteria on carcasses.
Establishments producing raw ground product from raw meat or
poultry supplied by other establishments cannot use technologies for
reducing pathogens that are designed for use on the surfaces of whole
carcasses at the time of slaughter. Such establishments may require
more control over incoming raw product, including contractual
specifications to ensure that they begin their process with product
that meets the standard, as well as careful adherence to their
Sanitation SOP's and HACCP plan.
By basing its Salmonella performance standards on the current
national baseline prevalence for each major species and product class,
FSIS is applying a uniform policy principle: all establishments must
achieve at least the current baseline level of performance with respect
to Salmonella for the product classes they produce. This policy is
based on the public health judgment that reducing the percentage of
carcasses with Salmonella will reduce the risk of foodborne illness,
and on the regulatory policy judgment that establishing for the first
time a clear standard for Salmonella, in conjunction with the
implementation of HACCP, will lead to significant reductions in
[[Page 38847]]
contamination rates. This policy is not based on a quantitative
assessment of the risk posed by any particular incidence of Salmonella
contamination or the determination of a ``safe'' incidence or level.
There is not currently a scientific basis for making such assessments
or determinations.
FSIS recognizes that this approach results in a range of
performance standards among the various product classes (see Table 4).
For example, the current Salmonella prevalence for broilers is 20
percent, while the current prevalence for steers and heifers is 1
percent. This range reflects the current level of performance for each
class of product, as reflected in the FSIS baseline surveys.
FSIS intends to revise its Salmonella performance standards
periodically as new baseline prevalence data become available and in
furtherance of the Agency's goal of reducing the risk of foodborne
illness. FSIS will periodically repeat its baseline studies to assess
the overall progress of the pathogen reduction effort. Also, as
indicated below in the discussion of the FSIS testing strategy, FSIS
will be conducting extensive Salmonella testing to ensure compliance
with the pathogen reduction performance standards. If the data from
this testing or future baseline surveys justify revision of the
performance standards, FSIS will promptly publish such revisions for
public comment in the Federal Register. FSIS anticipates revision of
these performance standards downward as justified by progress in
pathogen reduction and demonstrated reductions in the national baseline
prevalence of Salmonella. In making such adjustments, FSIS will take
into account the state of scientific knowledge, available technology,
feasibility, and public health benefits to be achieved. FSIS will also
consider the current level of industry performance with respect to
Salmonella prevalence in particular classes of livestock and poultry.
It is anticipated that such adjustments would more likely occur in
classes with the highest prevalence. FSIS originally proposed to call
these performance ``interim'' standards or targets. The final rule
removes that language.
Approximately 15 months after the publication of this final rule,
FSIS will convene a public conference to review available Salmonella
data and discuss whether they warrant refining the Salmonella
performance standards. Prior to the conference, FSIS will make
available the data resulting from the pre- implementation phase of the
FSIS Salmonella testing program. FSIS also will take advantage of this
conference to receive public input on the E. coli testing program. FSIS
will extend an invitation to all interested parties.
Additionally, FSIS intends to work closely with other Federal
agencies and the scientific community to improve the scientific basis
for establishing food safety performance standards for microbial
pathogens. In particular, the Executive Office of the President, Office
of Science and Technology Policy, will oversee a task force to
determine what research and data collection are needed to develop a
workable approach to quantitative risk assessment for foodborne
pathogens and determine the most cost-effective way of conducting the
necessary research. FSIS and other USDA agencies will participate in
this government-wide task force.
Determining Compliance With the Standard
The pathogen reduction performance standards specify for each
species and category of raw product a maximum number of positive test
results (c) permitted to be found in a specified number of samples (n)
for each class of raw product before the establishment will be deemed
to be exceeding the performance standard. The standards were determined
by first calculating for each category of product tested in the FSIS
national baseline programs and surveys the percentage of Salmonella
positives nationwide. This is, in effect, the performance standard that
must be achieved consistently by each establishment over time. Then the
number of samples to test (n) and the number of positives to allow from
among those samples (c) were calculated to provide approximately an 80%
probability of passing when the establishment is operating at the
national baseline prevalence of Salmonella positive results, i.e., just
within the performance standard. As discussed in the preamble to the
Pathogen Reduction/HACCP proposal and above with respect to E. coli
testing, the statistical criteria for evaluating Salmonella test
results balance the need to prevent establishments from failing to meet
the standard, based on chance results, and the need to ensure both that
violations are readily detected and that establishments have an
incentive to improve their performance beyond what is minimally
required by the standard. The resulting values for the pathogen
reduction performance standards are shown in Table 4.
Table 4.--Pathogen Reduction Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance
standard Maximum number
(percent Number of of positives
Class of product positive for samples to achieve
Salmonella) tested (n) standard (c)
(%)
----------------------------------------------------------------------------------------------------------------
Steers/Heifers.................................................. 1.0 82 1
Cows/Bulls...................................................... 2.7 58 2
Ground Beef..................................................... 7.5 53 5
Fresh Pork Sausage.............................................. *NA *NA *NA
Broilers........................................................ 20.0 51 12
Hogs............................................................ 8.7 55 6
Ground Turkey................................................... 49.9 53 29
Ground Chicken.................................................. 44.6 53 26
Turkeys......................................................... *NA *NA *NA
----------------------------------------------------------------------------------------------------------------
* Not available at this time.
FSIS has concluded that, for purposes of this rulemaking, it should
rely only on FSIS baseline data for determinations of the prevalence of
bacteria on which it is establishing standards. The proposal discussed
the possibility of relying on other data sources, such as industry
surveys or other reports in the scientific literature. No such data
were
[[Page 38848]]
submitted to FSIS in response to the proposal, and FSIS has concluded
that those alternative data sources are not likely to provide the
nationwide, objective data that are needed for the Agency's regulatory
purpose of establishing performance standards. FSIS will consider
modifications of the scope and approach to these surveys and additional
data sources, as the needs of public health dictate, but will continue
to rely only on data that are gathered with appropriate scientific
rigor.
FSIS has completed its baseline survey work and has issued reports
on its findings for Steers/Heifers, Cows/Bulls, Broiler Chickens,
Market Hogs, Ground Beef, Ground Chicken, and Ground Turkey. Copies of
these reports are available for inspection in the FSIS Docket Room (see
ADDRESSES).
FSIS is currently conducting the fresh pork sausage survey and will
begin the Baseline Program for turkeys soon. Therefore, performance
standards for fresh pork sausage and turkeys cannot be established at
this time. The performance standards for these two classes of products
will be published for public comment once FSIS's reports on the data
are available.
FSIS will determine an establishment's compliance with the
applicable pathogen reduction performance standard by taking the
indicated number of samples, generally at the rate of one or more per
day, testing each sample for Salmonella, and determining whether the
number of positive results is above the maximum permitted for that
product in the regulation.
FSIS has established performance standards for Salmonella on
carcasses and on raw products derived from meat and poultry. Because
Salmonella is more likely to be present on raw, ground, or comminuted
products than on the carcasses from which they are derived, raw,
ground, or comminuted product ordinarily will be the focus of FSIS
compliance testing in those establishments that both slaughter and
produce raw ground product.
The pathogen reduction performance standard applies to
establishments, not to individual products. As discussed,
microbiological testing of raw products for purposes of routinely
separating adulterated from unadulterated products is impractical at
this time. The pathogen reduction standard for Salmonella requires
testing of products not for purposes of determining product disposition
(although in some circumstances it may contribute to additional
inspection or compliance activities that do), but rather as a measure
of the effectiveness of the process in limiting contamination with this
particular pathogen. If an establishment fails to meet the standard, it
must institute corrective actions to lower the incidence of Salmonella
on all such product it produces as measured by subsequent testing, or,
ultimately, it must cease producing that product. The FSIS enforcement
strategy is further discussed below.
FSIS Testing Strategy
FSIS's Salmonella testing program will be implemented in two
phases, a pre-implementation phase and a compliance phase. The pre-
implementation phase will begin approximately three months after
publication of the final rule and initially will consist of an
establishment-by-establishment survey of the slaughter establishments
represented in the National Microbiological Baseline Data Collection
Programs. These establishments account for approximately 99 percent of
the total production volume for each of the major species slaughtered
nationwide. The testing in each slaughter establishment will be
conducted in a manner designed to provide a reliable picture of the
establishment's performance throughout a 12-month period, in relation
to the pathogen performance standard applicable to the species being
slaughtered. It is anticipated that initially FSIS will take
approximately 250 samples per establishment over a one-year period,
with testing to be completed before the implementation date for the
standard in each establishment.
FSIS will also conduct pre-implementation testing in ground product
establishments and in establishments that account for the remaining one
percent of production and that were not included in the FSIS baseline
surveys. This testing will be conducted in a manner and at a level that
takes into account the size and nature of the establishments involved.
FSIS will provide more detail on this testing soon in a separate
notice.
This pre-implementation testing will inform both the establishments
and FSIS, prior to the actual enforcement of the performance standards,
whether each establishment is already meeting the standard, is close to
meeting the standard, or requires substantial improvement to meet the
standard. As with all FSIS testing done to check compliance with the
pathogen reduction standards, the testing results will be provided to
the establishment by FSIS. These testing results will assist
establishments in designing and validating their HACCP plans as needed
to ensure that products meet pathogen reduction performance standards.
This information also will assist FSIS to more effectively target its
compliance testing after the standards go into effect, as discussed
below. This FSIS-generated data on the prevalence of Salmonella on
inspected products will be available to the public.
Upon the implementation of HACCP, and upon publication of Federal
Register documents concerning the pathogen reduction performance
standards for which baseline survey reports have not yet been
published, FSIS will initiate phase 2, the compliance phase, of its
Salmonella testing program in affected establishments. As an integral
part of its overall responsibility for food safety, FSIS will conduct
an ongoing testing program to determine compliance with the Salmonella
performance standard for all classes of livestock and poultry. In
addition, FSIS will conduct a program of targeted testing where
warranted. The frequency and intensity of this testing will be
determined based on past establishment performance, the establishment's
own generic E. coli test results, FSIS inspectional observations,
reports of illness associated with product produced at an
establishment, the results of Salmonella testing during the pre-
implementation phase, previous failures to meet the performance
standards, and other factors.
The costs to FSIS of this testing for Salmonella, estimated to be
approximately 2 million dollars annually, are addressed in the Final
Regulatory Impact Analysis of this rule.
FSIS Testing Methods
Details of the sample collection and testing procedures the Agency
will be using are in Appendix E, ``FSIS Sample Collection Guidelines
and Procedure for Isolation and Identification of Salmonella from Raw
Meat and Poultry Products.''
FSIS Enforcement Strategy
The objective of FSIS's enforcement policy with respect to
microbial testing is to achieve compliance with the regulations. With
respect to Salmonella, the Agency's goal is to achieve pathogen
reduction by ensuring that all slaughter and ground product
establishments meet the performance standards established by FSIS. FSIS
intends to achieve this goal through an enforcement strategy based on
the two-part testing program mentioned above: the ongoing testing,
which will include all establishments at some fixed interval,
irrespective of performance;
[[Page 38849]]
and targeted testing focusing on establishments unable to meet the
Salmonella performance standard when tested by FSIS or for the other
reasons discussed above.
The Salmonella enforcement strategy will embody an objective,
uniform systems approach to ensure that it is administered and applied
in a fair, equitable, and common-sense manner. The Agency will
carefully monitor and adjust its enforcement program on an ongoing
basis to ensure that its enforcement activities reflect these
principles while ensuring food safety.
If ongoing or targeted testing in an establishment indicates the
performance standard is not being met, FSIS will decide whether to
conduct follow-up testing on the basis of several factors. If an
establishment with Salmonella test results marginally above the limit
takes corrective action, FSIS could judge, based on the establishment's
actions and other factors relevant to ensuring food safety, that
immediate follow-up testing is not necessary. If, however, that
establishment were to take inadequate corrective action after failing
to meet the Salmonella performance standard, or if it simply ignored
that failure, FSIS will conduct a second series of tests. FSIS will
invariably conduct further testing at all establishments whose test
results significantly exceed the standard.
If an establishment fails the second, targeted series of FSIS-
conducted tests, the establishment will be required to reassess its
HACCP plan for the tested product, modifying the plan as necessary to
achieve the Salmonella performance standard. If the establishment fails
to modify its HACCP plan as necessary, or if it fails the third series
of targeted tests, FSIS will suspend inspection services. The
suspension will remain in effect until the establishment demonstrates
its ability to meet the performance standard.
The probability of an establishment failing the Agency's pathogen
reduction standard three consecutive times is less than 1% when the
establishment prevalence is at the limit of the standard.
Implementation Timetable for Pathogen Reduction Performance Standards
Slaughter establishments and establishments producing raw, ground,
and comminuted product subject to these pathogen reduction performance
standards must meet the Salmonella standard at the time the
establishment is required to implement HACCP. As explained in section
II above, HACCP implementation will be phased in based on establishment
size over a period of 18 to 42 months following the date of publication
of this final rule. FSIS originally proposed a single two-year delayed
effective date for its Salmonella performance standards. Many
commenters argued that it was not reasonable to hold all establishments
to the same effective date, and, furthermore, that it was more logical
to hold establishments to compliance with the standard after, rather
than before, HACCP was in place. This proposition also was strongly
endorsed by many people who attended an information briefing and public
meeting held by FSIS in Kansas City, Missouri, on May 22, 1995,
expressly for small meat and poultry establishments and small
businesses (60 FR 25869, May 15, 1995). They questioned, among other
things, the need for and wisdom of a common implementation date for
large and small establishments.
Harmonizing the effective dates with implementation of HACCP is
more consistent with the nature of the pathogen reduction standards as
measures of what establishments can and should achieve through HACCP-
based process control. It will bring 74% of the nation's slaughter
production of meat and poultry (by weight) under the performance
standard 18 months following publication of this final rule. It will
also facilitate the transition to HACCP, for both the FSIS workforce
and affected establishments, by requiring all establishments to meet
the performance standards as they implement HACCP.
Response to Comments
FSIS proposed to require that all meat and poultry slaughtering
establishments and establishments producing raw ground product conduct
daily microbial testing to determine compliance with interim targets
for the reduction of Salmonella. FSIS proposed to require a single
qualitative test per day, with daily results to be accumulated over
time to provide information regarding the performance of an
establishment's process and to collect data sufficient for process
control verification. Daily testing was considered the minimal sampling
necessary to detect process deviations within a realistic time frame.
The three issues most commonly raised by commenters concerning the
proposed microbial testing requirements were the proposed selection of
Salmonella as the indicator organism, the frequency of proposed
testing, and the disproportionate costs to small establishments. Some
commenters also argued that the regulatory approach was not justified
and exceeded FSIS's legal authority.
The Indicator Organism
Many commenters opposed the use of Salmonella as the indicator
organism, arguing that its low incidence in beef makes it a poor
indicator of pathogen reduction in the species, the positive/negative
test result is a weak measure of process control, and, compared to some
nonpathogenic alternatives such as generic E. coli, Salmonella tests
are more difficult, time-consuming, and costly. Others commented that
testing for Salmonella alone is unacceptable, as there is no direct
correlation between the presence of this organism and other pathogens
such as E. coli O157:H7, Listeria, and Campylobacter.
Various alternative indicator organisms were suggested, including
generic E. coli (biotype I), total plate counts, Enterobacteriaceae,
Total Viable Counts (TVC), and Aerobic Plate Counts (APC). Commenters
who recommended alternatives stated that tests for these organisms
would be better indicators for process control and fecal contamination
levels than tests for Salmonella. Still others requested that more
studies be conducted to determine which type of indicator organism
would be most useful for verifying process control.
Some commenters recommended retaining Salmonella as the target for
pathogen reduction, but suggested adding a requirement for generic E.
coli testing because it serves effectively as an indicator of fecal
contamination in all species. A minority of commenters supported the
proposed use of Salmonella as the indicator organism because of its
significance as a cause of foodborne illness and because there are
relatively simple tests available for detecting Salmonella. Some
commenters recommended requiring testing for Salmonella and additional
pathogens in selected species or products based on the degree of public
health risk posed by the pathogen. A number of consumer groups
requested a pathogen goal of zero for E. coli O157:H7.
These comments are generally addressed by the FSIS decisions to
require slaughter establishments to test for generic E. coli as a means
to verify process control for fecal contamination, and to have FSIS
conduct testing for Salmonella for pathogen reduction.
FSIS considers systematic measures to prevent and remove fecal
contamination and associated bacteria, coupled with microbial testing
to verify effectiveness, to be the state of the art in slaughter
establishment sanitation. Further, FSIS believes that testing for
generic E. coli is the appropriate and necessary means by which meat
and poultry slaughter
[[Page 38850]]
establishments must verify their process controls. FSIS reviewed
written comments received on the original proposal and comments made at
the scientific conferences and public meetings, as well as available
scientific data, and has decided to require slaughter establishments to
conduct testing for generic E. coli to verify process controls.
The Agency has concluded that each kind of testing serves an
important function. Both play a major part in the Agency's pathogen
reduction efforts, and working in unison will permit the Agency to use
its inspection resources more effectively, and efficiently, thereby
enhancing inspection.
E. coli testing for process control verification and Salmonella
testing to enforce the pathogen reduction performance standard both are
aimed at FSIS's objective to reduce the incidence of disease caused by
foodborne pathogens. However, E. coli testing and Salmonella testing
aim at the objective from different directions.
An ongoing screen for generic E. coli serves both the establishment
and FSIS as a means of verifying that a slaughter facility's process is
``in control'' with regard to prevention of fecal contamination of the
carcasses being produced. In other words, it becomes a marker for
verifying a slaughter establishment's adherence to the zero tolerance
for fecal contamination. Such testing provides a standard measure for
verification of process control at the critical slaughter stage of
production. Without such a standard measure, there is no objective
basis upon which either the establishment or FSIS can determine the
adequacy of process controls, from one establishment to another, in
preventing fecal contamination. It will permit establishments to make
ongoing adjustments or changes to their slaughter process when
necessary to meet the performance criteria. The test results will also
guide FSIS's ongoing inspection, permitting adjustments in intensity
and focus as appropriate.
Generic E. coli testing to verify process control alone, however,
does not adequately address legitimate public health concerns about
pathogenic bacteria in and on raw product. E. coli (except for certain
pathogenic subgroups) is not itself a cause of foodborne disease. It is
a ``surrogate marker'' or ``indicator'' for fecal contamination, which
in turn is a source of many pathogens that may contaminate products.
Fecal contamination, however, does not always correlate with the
presence of pathogens; high levels of E. coli may be present without
pathogens, and pathogens may be present without high E. coli levels.
Because testing for E. coli cannot serve as a surrogate for the
presence of Salmonella, FSIS's specific public health objective of
reducing nationwide Salmonella levels on raw meat and poultry products,
including raw ground products, requires a standard and a testing regime
that are directed at that pathogen.
The pathogen reduction performance standard for Salmonella must be
met by all inspected establishments producing raw meat and poultry
products. Agency testing for Salmonella is necessary for enforcement of
that requirement. Slaughter establishments' E. coli testing, a means
for verifying process control for fecal contamination, should promote
improved process controls which should, in turn, result in reductions
of Salmonella and other pathogens. But, E. coli testing cannot measure
actual reductions and control of Salmonella nor be the basis for Agency
enforcement of the pathogen reduction standards.
The test results from both kinds of testing are valuable to the
Agency in the shift to a HACCP-based regulatory regime, but their value
comes from the way they work together to verify the effectiveness of an
overall system of preventive process control. The Agency continues to
believe that pathogen reduction in inspected establishments requires
that establishments build into their operations preventive measures and
systems to reduce the potential for pathogens to be on products to
begin with, and that such systems must be establishment-produced and
establishment-specific. The Agency's HACCP and Sanitation SOP's
regulations are intended to do that. However, these regulations are not
self-enforcing. The Agency's inspection mandate does not permit it to
simply assume that an establishment's systems are in fact producing
uniformly safe and unadulterated products. Pathogen reduction will be
achieved instead by the combination of HACCP plans validated as
effective for pathogens of concern, E. coli testing by the
establishment to provide on-going verification of process control for
fecal contamination, and Salmonella testing by FSIS to enforce
compliance with the pathogen reduction performance standards.
Frequency and Cost of Testing
Many commenters questioned the proposed frequency of daily testing
for each species and for raw, ground products. The majority of
commenters who opposed daily testing stated that this testing
requirement would place an unfair cost burden and have a negative
economic impact on some establishments, especially small volume
establishments and establishments producing multiple species and
multiple ground products that would require multiple tests. These
commenters stated that under the proposed sampling methodology, a small
establishment could conceivably conduct more tests per day than a very
large establishment with a much higher production volume. Also
mentioned was the fact that many of these establishments do not have
on-site testing facilities and would have an additional cost of
shipping samples for testing.
To minimize the economic impact on establishments, especially small
establishments, some commenters suggested that FSIS should pay for
microbial testing. Others recommended less than daily testing or other
changes to the proposed sampling frequency. Various alternatives to the
proposed sampling protocol were mentioned, but the sampling scheme
recommended most often as the most equitable, and the one FSIS is
requiring, is one based on production volume.
Although many commenters requested less frequent testing than that
proposed, others supported the one sample per day testing requirement
as an efficient means of verifying process control. Still others
recommended testing even more frequently than once per day. These
commenters asserted that testing once a day is inadequate to verify
process control or to screen out product with pathogens. Their main
concern was that the proposed sampling frequency and moving sum
statistical procedure would allow inadequate process control to go
undetected, resulting in large quantities of suspect product being
produced; recommendations were made for a testing frequency more
proportional to an establishment's production volume.
Some commenters requested that exemptions from the proposed daily
microbial testing be made for small establishments and establishments
that have consistently complied with their HACCP programs. Others
requested exemptions for specific products including: raw ground meat
products; cured products; thermally processed canned foods; frozen
foods; boxed meat and beef and pork carcasses from other inspected
establishments; minor species (i.e., sheep, lamb, goats, equines,
guineas); and raw ground products to be further processed as fully
cooked, ready-to-eat items, while others stated that exemptions for
these items would be inappropriate.
[[Page 38851]]
FSIS has modified the proposal in response to these comments. As
explained above, FSIS is requiring E. coli testing in slaughter
establishments where the initial and primary opportunity for fecal
contamination occurs. FSIS is not requiring E. coli testing of
processed products. A more limited testing requirement is possible
because oversight of slaughter establishment verification testing for
E. coli is not the sole means relied upon by FSIS to detect or prevent
lack of process control. It is only one of many aspects of
establishment operations FSIS will inspect in assessing the adequacy of
an establishment's process controls. In particular, FSIS will
increasingly rely on its verification that HACCP systems are working as
intended. HACCP principles require establishments to identify CCP's,
monitor them to see that they are in control, and take appropriate
corrective action when monitoring detects a deviation. This is where
control must be exercised by the establishment and where any lack of
control will be detected in a establishment operating under a validated
HACCP system.
FSIS has reconsidered the proposed requirement of daily testing in
all slaughter establishments, in part because of the unnecessary and
disproportionate economic impact that would occur for some small
establishments. Instead, FSIS is requiring slaughter establishments to
test carcasses for generic E. coli at frequencies corresponding to
production volume. In addition, slaughter establishments will have 6
months, not just 3 months as proposed, after publication of the final
rule to begin testing carcasses for generic E. coli. Further, very low
volume establishments may not need to do more than one set of 13 E.
coli tests annually, and such establishments slaughtering more than one
species need not test both. These changes will significantly reduce the
cost impact of mandatory testing for small establishments, while
providing adequate and useful information to verify process control.
In addition to requiring testing for generic E. coli by slaughter
establishments at a frequency relative to the establishment's
production volume, Salmonella testing will be conducted by FSIS.
``Minor species,'' such as sheep, goats, equines, ducks, geese, and
guineas, are not being addressed at this time because the Agency is
addressing first the most commonly consumed foods under its
jurisdiction. FSIS intends to address how best to gather data on and
develop testing requirements and performance criteria and standards for
these other food animals at a future date.
Legal Authority for Testing Requirement
Several commenters have questioned FSIS's legal authority for the
proposed microbiological testing program. These comments are still
relevant despite the differences between the proposed and final rules
for microbiological testing.
The major change in the final rule is that FSIS is not adopting the
proposed Salmonella testing regimen. As proposed, results of a series
of establishment-conducted Salmonella tests would have been used to
accomplish two goals: to verify process control and to enforce the
prevalence targets for pathogens in raw products. Instead, FSIS is
promulgating separate provisions to address these two regulatory goals.
The first provision requires that slaughter establishments test
carcasses for E. coli so that the effectiveness of the establishment's
sanitation and process control measures can be assessed in an
objective, uniform manner. The second provision sets a pathogen
reduction performance standard to bring about reductions in the
prevalence of Salmonella on raw meat and poultry products. This
standard will be enforced by an FSIS-conducted testing program, and
will require establishments with prevalence of Salmonella above the
standard to change their operations to meet that standard. Failure by
an establishment to achieve the standard could result in Agency
sanctions, as discussed above. This standard will also encourage
innovation to reduce pathogens throughout the industry.
One commenter argues that, because this regulatory strategy is
precedent-setting, FSIS has a greater than usual burden of articulating
the legal basis for it. This commenter notes that the testing
regulation does not rely on a finding that the presence of the targeted
organisms causes specific lots of product to become adulterated, as is
the case with E. coli O157:H7 in ground beef. This commenter then
argues that FSIS is relying upon a vague ``sanitation theory'' as its
legal basis, and that the Agency has a greater duty to articulate its
legal basis when new regulations impose new kinds of costs, like
mandatory E. coli testing, or when the Agency is establishing a new
regulatory policy.
This commenter believes that FSIS reliance on a ``sanitation
theory'' is legally flawed because, if the Agency is unable to tell
establishments how to correct a failure to meet the established
targets, it cannot legally require microorganism testing, or impose
sanctions for failure to meet established standards.
FSIS has ample statutory authority under the FMIA and PPIA to
promulgate these microbiological testing provisions. The meat and
poultry inspection statutes mandate Federal regulatory oversight of
unusual intensity and comprehensiveness, and they provide the Secretary
broad rulemaking authorities to implement them. The primary goal of the
statutes is to prevent adulterated or misbranded meat and poultry
products from entering into commerce by inspecting meat and poultry
products and the establishments that produce them before the products
are introduced into commerce. Such inspections are supplemented by
compliance actions to remove adulterated or misbranded products from
commerce and to apply appropriate sanctions against violators of the
law. FSIS regulations under the FMIA and PPIA may be divided into two
categories: (1) regulations prescribing the conditions under which, and
the manner in which, mandatory inspections are conducted; and (2)
regulations directed more broadly at preventing adulteration or
misbranding of products, preparation of products in violation of the
law, and sale of such products in commerce.
These two regulatory categories are interrelated. The broader
category is similar to regulations imposed on foods generally by the
FDA under the Federal Food, Drug, and Cosmetic Act. However, FSIS
authorities also require compliance with the inspection provisions of
the acts and regulations by anyone slaughtering poultry or livestock,
or preparing poultry products, or meat or meat food products for use as
human food. Thus, the requirements that establishments must meet to
obtain inspection and to have products marked ``inspected and passed''
comprise a unique statutory scheme which provides the Secretary with
broad rulemaking authorities.
From their inception, the meat and poultry inspection laws have
recognized that sanitary conditions in establishments are critical to
the safety and wholesomeness of the products being produced. Any
product found to have been ``prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health'' is adulterated.
No product will be granted inspection or marked ``inspected and
passed'' unless the sanitary conditions and practices required by the
Secretary are maintained.
[[Page 38852]]
It is important to distinguish the statutorily required finding
that a product is not adulterated from the absence of a finding that it
is adulterated. Only products found not to be adulterated may be marked
``inspected and passed.'' Even if the evidence does not compel an
inspector to find that a product is adulterated, it, nonetheless, may
be enough to prevent him from finding that it is not adulterated. This
means that products may not be distributed for food use without the
affirmative determination that they are not adulterated. Products as to
which such an affirmative determination has not been made must be
retained at the establishment pending such determination. They are
being detained because they have not been inspected and passed, not
because they have been found to be adulterated.
Thus, FSIS clearly has the authority to require that establishments
slaughtering livestock or poultry conduct and record tests for E. coli
on carcasses to measure how well contamination is being avoided. These
tests provide information by which establishments may evaluate and
ensure the effectiveness of their sanitary procedures and related
process controls in preventing product contamination during slaughter
and dressing.
Although E. coli testing will not be used to determine the
disposition of inspected products, it will be an effective indicator of
the presence of fecal contamination that is not visible and therefore
not detectable by traditional inspection methods. It will also provide
FSIS with information necessary to determine how best to conduct
inspection to ensure that product is not being adulterated.
Similarly, FSIS has clear authority to establish a Salmonella
standard for producers of raw meat and poultry to reduce the public's
exposure to Salmonella and associated pathogens from inspected meat and
poultry products. The Salmonella standard, like the criteria for E.
coli on carcasses, is based on the national baseline prevalence of the
bacteria for the product of concern. However, unlike the E. coli
criteria, which are, in essence, guidelines, the Salmonella standard
must be met. Compliance will be determined by Agency testing.
FSIS is continuing its policy of permitting raw meat and poultry
products to be marked and labeled ``inspected and passed,'' despite the
known or suspected presence of some pathogenic bacteria. FSIS
recognizes that currently there is no available technology (with the
possible exception of irradiation) to ensure that raw product bears no
pathogenic microorganisms.
However, there is overwhelming evidence that raw meat and poultry
products are frequently contaminated with pathogens and expose
consumers to avoidable and unacceptable risks of foodborne illness.
FSIS's statutory mandate to protect consumers from adulterated product
is not limited to actions associated with inspection. The Secretary may
also regulate how meat and poultry products are stored and handled by
anyone who buys, sells, freezes, stores, transports, or imports them,
to ensure they are not misbranded or adulterated when delivered to the
consumer.
The new pathogen reduction standards for Salmonella are necessary
to establish that raw product is being produced under sanitary
conditions, has not been prepared, packed or held under insanitary
conditions, and is not for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food.
The fact that the new performance standards and guidelines do not
specify how the E. coli process control verification performance
criteria or the Salmonella pathogen reduction standard must be met does
not undercut the reasonableness or the legal basis of either testing
program. Process control and the production of product that is not
adulterated is the responsibility of the establishment, not the
government. The Agency is responsible for establishing and enforcing
reasonable standards; it intends to give the industry the maximum
flexibility to decide how best to meet such standards. It does not
intend to regulate or prescribe how the standards are to be met. FSIS
will provide guidance and assistance to the industry, especially small
businesses. But it is not legally obliged to provide technical services
to establishments in finding the most efficient and effective way to
operate within the E. coli criteria and to meet the Salmonella
reduction standard.
In summary, FSIS has concluded that the E. coli testing program and
the Salmonella reduction standard are fully supported by the FMIA and
PPIA.
Performance Standards for Process Control
A related comment asserted that FSIS's proposed Salmonella standard
was not a standard at all, but instead was merely an unenforceable
criterion because its violation would not alone support seizure or
condemnation of products. FSIS agrees with the principle that a
regulatory standard should be enforceable, but does not agree that a
regulatory ``standard'' must be limited to product-specific
requirements, or to enforcement by seizure or condemnation of products.
The Agency acknowledges that historically it has used the term
``standard'' normally to refer to regulations concerning particular
products, e.g., standards of identity regulations, but notes that
current government-wide regulatory reform efforts stress the use of
``performance standards'' to describe the desired focus of government
regulations generally. FSIS intends now to issue regulations consistent
with the notion behind ``performance standards,'' that to the extent
possible regulations should tell regulated entities what they must
achieve to comply with the law, while providing maximum flexibility
regarding how to achieve the standard. Thus, FSIS agrees that one test
of a ``standard'' might be that violation of that requirement alone
supports some sort of regulatory sanction, but does not agree that
``standards'' should be limited to product-specific regulations or to
enforcement actions directed at specific products. The FMIA and PPIA do
not limit the Agency to product-specific regulations and enforcement
activities, and for reasons fully discussed earlier in this preamble,
the Agency has concluded that standards directed at processes are, at
this time, the only practical way in which to effectively address the
hazard presented by microbiological pathogens on raw meat and poultry
products.
Basis for Target Levels
Some commenters questioned the validity of microbial target levels
established by FSIS, while others supported FSIS national baseline
studies as an effective way to evaluate industry performance. After
careful review, the Agency considers it reasonable and appropriate to
use the distribution of results observed for each animal species in the
FSIS baseline surveys as the basis for both the E. coli criteria and
the pathogen reduction performance standard for Salmonella. These are
currently the best available data on the nationwide prevalence and
level of microbial contamination of raw meat and poultry products. The
data demonstrate that the E. coli process control verification criteria
and the Salmonella pathogen reduction standard are being achieved by
many establishments with today's technology and therefore are
achievable by all establishments.
FSIS Nationwide Microbiological Baseline Data Collection Programs
and its Nationwide Microbiological Surveys provide similar data, but
the
[[Page 38853]]
``Programs'' generally involve more extensive sampling over a longer
period, generally 12 months, than the ``Surveys'', which are generally
limited to 6 months of data collection. They both have provided data
for an ongoing microbial profile of carcasses and other raw meat and
poultry products for selected microorganisms or groups of
microorganisms of various degrees of public health concern of value as
indicators of general hygiene or process control.
As explained above, FSIS plans to revise the performance criteria
and standards as more current baseline data become available from
future baseline surveys, through establishment E. coli testing, through
FSIS Salmonella testing, or from other FSIS testing that may be
appropriate for establishing criteria and standards.
Although the majority of commenters focused on the issues mentioned
above, a number of others addressed various aspects of the proposed
rule such as microbial testing methodology, the concept of end product
testing, the role of FSIS personnel in test verification, enforcement
actions for non-compliance, and laboratory qualifications.
Methodology for Meeting Targets
Some commenters raised objections to use of the ``moving sum''
statistical procedure for determining when microbial testing results
are within the process control. Moving sum procedures are recognized in
the field of statistical quality control. The American National
Standard ``Guide for Quality Control Charts'' 11 identifies two
principal uses of such charts: assisting judgment as to whether a state
of control exists and attaining and maintaining control. In order to
judge whether a state of control exists, operators must analyze
``collectively an accumulation of quality data.'' In the proposed
regulation FSIS took this view of the purpose of the moving sum
procedure: establishments would need to verify that a state of control
exists with respect to the interim target set by the Agency. FSIS did
not claim, however, that the procedure would be useful for the second
purpose, attaining and maintaining control. That requires more timely
and probably more intense monitoring of process parameters at CCP's.
---------------------------------------------------------------------------
11 American National Standard ANSI Z1.1-1985. ``Guide for
Quality Control Charts.'' American Society for Quality Control.
Milwaukee, WI.
---------------------------------------------------------------------------
The proposed approach to use testing to measure process control was
designed to inform establishments how they are currently operating with
respect to the relevant target, and to help them track progress toward
meeting that target. A simple plot of the moving sum chart would give
them sufficient feedback for this purpose.
Some commenters recommended that the moving window verification
program should use a 90% probability criteria, rather than 80%, to
reduce the possibility of the testing procedure erroneously identifying
an establishment as not meeting the pathogen target. The Agency notes
that the moving sum procedure was designed to measure effectiveness of
process control with respect to an interim performance standard (called
a target in the proposal) based on current industry performance (as
determined by a baseline study). This measure was intended to be the
first step in holding establishments accountable for meeting acceptable
levels of performance. As such, the Agency wanted to be able to readily
identify establishments operating above the target and wanted to
provide an incentive for establishments to produce at levels better
than (below) the target. Giving establishments producing at the target
only an 80% chance of passing was expected to promote this. Giving
establishments producing at the target a higher chance of passing
(e.g., 95%) would reduce both the incentive to do better and the
ability to detect establishments above the target.
Sample Size
Others specifically addressed the proposed sample size,
recommending that the same number of samples be used for all species.
Not all species have the same risks of failure, in part because of the
varied incidence of pathogens, as was determined in FSIS's baseline
surveys. The proposed sampling rate was the same for all
establishments, one per day. Thus the sampling was the same for all
establishments, only the rules for interpreting results were different.
The number of results included in the window differed by product class
because the target percents positive differed by product class. It was
necessary to employ different-sized windows to maintain a fixed
probability of passing (80%) at the target for all product classes
while choosing as short a window as possible and allowing at least one
positive in the window.
Testing Methodology
Other commenters asked for clarification on testing methodology.
Some remarked that using a sponge or swab method to sample carcasses is
preferable to the proposed excision method because the proposed method
is time consuming, cumbersome, and expensive, and it may mutilate and
contaminate the carcass. The Agency agrees and has elected to use non-
destructive sampling methods.
Others asked for clarification of enforcement actions that would
result from an establishment not meeting its microbial targets. How the
rule will be enforced is addressed above.
Role of Inspectors
Still others asked about the role of inspection personnel in
verification testing and expressed concern about the amount and type of
training inspection personnel would receive to analyze test results.
The final rule makes slaughter process control verification testing
(E. coli) the responsibility of establishments slaughtering livestock
or poultry, although FSIS inspectors may also collect samples for E.
coli testing as needed to carry out their oversight responsibilities.
FSIS personnel sampling carcasses for Salmonella to ensure that
establishments are meeting the pathogen reduction performance standard
will send the samples to an Agency laboratory for analysis. FSIS
personnel have been involved in collection of samples for FSIS's
baseline surveys, and have been trained and are highly qualified to
collect samples for this regulatory program. Inspectors will work with
other program officials, including scientifically trained experts, in
analyzing test results and making appropriate regulatory decisions.
Inspectors will receive training to prepare them for their role in this
process.
Laboratories
Some commenters asked for clarification regarding qualifications
for in-house and outside laboratories. They stated that laboratories
should be required to use standardized techniques for analyzing test
results.
The microbiological test method used by the establishments must be
AOAC validated techniques, or other methods validated by a scientific
body in collaborated trials against the three tube most probable number
(MPN) method and agreeing with the 95 percent upper and lower
confidence interval, as discussed in the E. coli Methods Section.
Establishments are responsible for the accuracy of the tests of their
samples. If the samples are not analyzed by the establishment, the
establishment, perhaps in concert with a trade association, should
ensure that the laboratory it chooses is reputable and
[[Page 38854]]
adheres to a Quality Control/Quality Assurance Program.
Alternative Sampling Under HACCP
Other commenters stated that the proposed microbial testing system
does not reward very clean establishments by granting reasonable
reductions in testing when significant periods are pathogen free. They
recommended that once a facility has implemented its HACCP program, the
required frequency for mandatory microbial testing should be reduced or
eliminated altogether.
In this final rule, a slaughter establishment successfully
operating under a validated HACCP plan may reduce the specified
sampling frequency as long as the alternative sampling plan is an
integral part of the establishment's verification procedures for its
HACCP system. FSIS does, however, reserve the right to determine that
the alternative frequency is inadequate to verify the effectiveness of
the establishment's process controls. In that case, FSIS would notify
the establishment in writing of its finding, advise that the frequency
specified in the regulation must be maintained, and specify any
conditions an acceptable alternative frequency would have to meet to be
found acceptable to the Agency.
Relationship to HACCP
Finally, some commenters stated that the proposed end-product
testing is inconsistent with HACCP principles and that establishments
should decide for themselves through hazard analysis whether testing is
needed and at what frequency. Others objected to the concept of end-
product testing because it only measures effectiveness over a small
percentage of a production lot and has limited value in measuring the
overall success of a HACCP plan. Still others concluded that placing an
emphasis on end-product testing gives consumers a false sense of
confidence about the safety of meat and poultry products. A few
commenters were concerned about product liability due to product
recalls stemming from test results.
The objective of the generic E. coli testing is to verify that
process control has been maintained by the establishment throughout the
slaughter and dressing process and that resultant carcasses are
produced hygienically. If processes are under control for E. coli, the
potential presence of enteric pathogens will be reduced. End-product
verification testing of this kind is a well recognized component of
HACCP-based process control.12 The goal of FSIS's Salmonella
testing program is to verify that pathogen reduction performance meets
current standards in each establishment and thereby effect a nationwide
reduction in the incidence of that organism and other enteric pathogens
on raw meat and poultry products. The end of production is the only
point that reflects all steps in the production process and,
ultimately, all elements of the HACCP system. The seventh HACCP
principle is verification that the HACCP system is working; one cannot
verify that HACCP is working in slaughter establishments (controlling
fecal contamination/pathogens) without some end-product testing, so
end-product testing is not inconsistent with HACCP principles. The two
different kinds of testing programs: (1) E. coli testing by
establishments to verify control of fecal contamination; and (2)
Salmonella testing by FSIS to hold establishments accountable for
meeting pathogen performance standards, are both forms of end-product
testing that FSIS considers consistent with HACCP.
---------------------------------------------------------------------------
\12\ National Advisory Committee on Microbiological Criteria for
Foods. 1994. ``Hazard Analysis and Critical Control Point Systems.''
FSIS, USDA.
---------------------------------------------------------------------------
End-product testing as part of an overall system of HACCP-based
process control and performance standards should not give consumers a
false sense of confidence about the safety of meat and poultry
products. FSIS recognizes that limited end-product testing alone
provides little assurance of safety, but, as part of a process control
system, appropriate end-product testing brings rigor and accountability
to the system and should appropriately increase consumer confidence in
the safety of products. By requiring HACCP, FSIS is in fact moving away
from sole reliance on end-product assessments for lot acceptance, an
approach that is the opposite of the HACCP system approach to food
safety. FSIS recognizes that producing safe food requires preventing
hazards throughout the process rather than relying solely on end-
product testing to ensure safety. Establishments' liability to civil
lawsuits should not be adversely affected by this rule precisely
because it is an establishment's process, not individual lots of
product, that is being assessed, for inspection purposes, on the basis
of this testing.
V. Other Issues and Initiatives
Antimicrobial Treatments
FSIS proposed that all slaughter establishments apply at least one
antimicrobial treatment or other approved intervention to livestock and
poultry carcasses prior to the chilling or cooling operation. Proposed
treatment methods included chlorine compounds, hot water, and any
antimicrobial compound previously approved by FSIS and listed in the
meat or poultry regulations. Product prepared for export to countries
that restrict or prohibit the use of antimicrobial treatments would
have been exempted from this requirement upon application to the
Administrator.
While most commenters generally agreed that antimicrobial
treatments could play an important role in reducing contamination with
pathogenic microorganisms in slaughter establishments, many commenters
opposed mandating such treatments. The commenters argued that mandating
the use of antimicrobial treatments in slaughter operations would not
be consistent with the HACCP philosophy and the overall shift by FSIS
to greater reliance on performance standards.
FSIS agrees with these commenters and has decided not to mandate
the use of antimicrobial treatments in slaughter establishments. FSIS
continues to believe that slaughter establishments will find that these
treatments can play a useful role in reducing pathogens and improving
the safety of meat and poultry products. Rather than mandating specific
antimicrobial treatments, FSIS will rely on other requirements in this
final rule to ensure that slaughter establishments are achieving an
acceptable level of performance in controlling and reducing harmful
bacteria on raw product.
The principle of using antimicrobial treatments as an intervention
to control pathogens on meat and poultry carcasses was strongly
endorsed by most commenters. However, few agreed that the treatments
should be mandatory. A majority of commenters recommended that
antimicrobial treatments be voluntary interventions. Establishments
would decide if antimicrobial interventions were needed to control
specific hazards at one or more critical control points in the
slaughter process.
Similarly, a number of commenters tied antimicrobial treatments to
microbial testing. They argued that carcass treatments should not be
required in establishments that consistently meet or exceed performance
standards for microbial contamination.
Commenters said FSIS should focus its regulatory efforts on
measurable, attainable goals and not on prescriptive requirements for
particular processing steps. Several commenters emphasized the need for
``whole system'' interventions instead of single
[[Page 38855]]
techniques such as antimicrobial treatments. They said these
interventions work best when they are tailored to species and product
hazards, individual establishment configurations, and processing
methods. Furthermore, some commenters cited a danger that
establishments and inspection personnel would focus on the treatment
function itself instead of broader food safety goals.
FSIS generally agrees with these comments. FSIS has concluded that
its food safety goals can be achieved more effectively and more
efficiently by requiring HACCP-based process control combined with
appropriate performance criteria and standards than by mandating
specific interventions, such as antimicrobial treatments. New
technological interventions will play a significant role in reducing
the risk of foodborne illness and should be adopted as part of an
overall system of HACCP-based process control. FSIS expects that such
treatments may be used by establishments to meet the process control
performance criteria and pathogen reduction performance standards FSIS
is adopting in this final rule.
A few commenters opposed mandating antimicrobial treatments because
they believed their use would allow for correction of sloppy carcass
dressing procedures. These commenters argued that antimicrobial
treatments, whether mandatory or voluntary, emphasize post-
contamination clean-up rather than prevention.
FSIS also received many comments which addressed the four proposed
antimicrobial treatment methods. Many commenters stated that FSIS
should not restrict establishments to these particular antimicrobial
interventions.
A variety of commenters addressed technology issues concerning the
proposed treatment methods themselves. Many said that too few studies
have been conducted to show which interventions are most effective and
efficient for specific pathogens associated with particular species in
individual slaughter establishment configurations. Some argued that the
studies FSIS cited in its proposal were too narrow and did not
adequately demonstrate effectiveness. They said additional studies were
needed to determine the practicality, efficacy, and expense of various
antimicrobial treatments in commercial settings. In addition, some
commenters were concerned that insufficient research was available on
whether the elimination of competitive micro flora would allow
uninhibited growth of pathogenic bacteria.
Individual antimicrobial techniques were also criticized. For
example, hot water sprays were said to pose dangers to establishment
personnel applying the treatments at temperatures necessary for
effectiveness. Hot water sprays raise carcass temperatures with
consequent melting of surface fat in some species, contribute to
quality defects such as change in product color and partial cooking,
and result in higher energy costs. Commenters recognized, however, that
hot water was the only currently available nonchemical intervention
that could be implemented at comparatively low cost. Other commenters
criticized lactic, acetic, and citric acid solution sprays because they
have low effectiveness as a treatment against E. coli O157:H7. The
possible carcinogenic effects of chlorine were also mentioned, as were
concerns about water reuse and possible environmental effects from
spray effluents.
Commenters also suggested a variety of alternative antimicrobial
interventions that could be used by establishments. These interventions
included irradiation and radiation-emitting electronic devices such as
x-rays and linear accelerators; high-energy ultraviolet light; pulsed
light, sonic, infrasonic, and ultrasonic emitters; chemicals such as
copper sulfate in the pentahydrate form, chlorine dioxide, and hydrogen
peroxide; procedures such as pre-evisceration washes, water curtains,
counter current or counter flow scalders, the Peroxi bicarb process,
automatic warm fresh water rinses, ozonated water, steam
pasteurization, steam vacuuming, hot wax dipping, and singeing.
A number of commenters also suggested that FSIS establish protocols
to evaluate various forms of antimicrobial procedures and treatments.
FSIS could then publish a regularly updated list of acceptable
treatments and provide guidelines for their use in a commercial
setting. It was argued that this process would give establishments the
flexibility to implement any interventions they deem necessary. Others
said FSIS should set up a predetermined protocol for antimicrobial
agents or an expedited review process for new technologies.
FSIS agrees that issues of effectiveness, product and worker
safety, product quality, interference with inspection, and
environmental impact can be raised about most food safety
interventions, including antimicrobial treatments. Therefore, to
facilitate industry development of new technologies, FSIS has
established a process that will facilitate this development.
On May 25, 1995, FSIS published a notice in the Federal Register
(60 FR 27714) that presented guidelines for preparing and submitting
experimental protocols to FSIS for use by establishments wishing to
conduct trials of new technologies and procedures. In that notice, FSIS
confirmed its long-standing commitment to foster innovative
technologies and procedures that more effectively protect meat and
poultry products from microbiological and other hazards. Specifically,
FSIS encouraged the development of efficacious, practical and
manageable technologies and procedures by establishments.
FSIS also published guidelines (FSIS Directive 10,700.1) for
establishments to use for submitting written proposals and protocols to
FSIS for approval to conduct experiments. Agency approval is required
in cases where the intended technology, procedure or process may affect
(1) product safety or lead to economic adulteration, (2) worker safety,
(3) environmental safety, or (4) inspection procedures.
Similarly, FSIS published a proposed rule in the Federal Register
(60 FR 67459; December 29, 1995) that will facilitate the review and
approval of substances intended for use in or on meat and poultry
products. Under the proposed procedures, FSIS would no longer issue its
own regulations listing substances it finds suitable for use in meat
and poultry products. Instead, FDA's regulations would specify whether
a substance approved for use in foods under the Federal Food, Drug, and
Cosmetic Act may be used in or on meat or poultry products.
Many commenters stated that antimicrobial interventions should be
permitted at any stage in the slaughter process: live animal, pre-hide
removal, pre- or post-carcass wash, pre- or post-chill, or just prior
to fabrication.
Some commenters argued that the proposed treatments would seriously
compromise the Kosher ritual salting process, while others said the
interventions would conflict with Confucian and Buddhist-style poultry
prepared for religious rites.
A number of commenters questioned the relationship between FSIS's
policy on zero tolerance for fecal contamination and its antimicrobial
treatment proposal. In particular, they were concerned about where in
the process zero tolerance would be measured.
Finally, several commenters requested a practical definition of
``feces'' as a means to resolve disagreements between inspectors and
establishment personnel about trimming contamination.
[[Page 38856]]
Cooling and Chilling Requirements for Raw Meat and Poultry
FSIS proposed that establishments slaughtering livestock be
required to chill carcass surfaces and hot-boned meat to 50 deg.F
(10 deg.C) within 5 hours and then to 40 deg.F (4.4 deg.C) within 24
hours of slaughter or meat and bone separation. Chilling of meat
products such as liver and cheek meat would have been required to begin
within one hour of removal from a carcass. The proposed rule also would
have changed existing poultry chilling requirements (Sec. 381.66) to be
comparable with those proposed for meat. Chilling would have been
required unless the raw product was going directly from slaughter to
heat processing.
The proposal also would have required that establishments maintain
raw meat and poultry products at an internal temperature of 40 deg.F or
below while in the establishment and before release into commerce. Raw
products not chilled in accordance with the requirements would have
required further processing to kill pathogens or would be condemned.
Lastly, the proposal would have required each establishment
handling raw product to have a written plan for temperature controls
and monitoring and make monitoring records available to FSIS upon
request.
The proposed rule was based on good manufacturing practices
generally prevalent in the industry. FSIS's position was that
temperature controls, which are known to prevent bacterial growth, are
an accepted part of current industry practices, are already required by
regulation for poultry carcasses, and should be mandated for all raw
product to minimize the possibility that raw products leaving official
establishments bear significant levels of pathogenic microorganisms.
Commenters generally supported the concept that establishments
should be required to chill raw product as a means of minimizing the
growth of harmful bacteria. Some commenters supported the time and
temperature requirements as proposed. Others argued that the specific
time and temperature combinations in the proposed rule were unduly
restrictive and unworkable. A number of commenters advocated ``more
realistic'' cooling requirements that take into consideration
establishment and product variety, different processing operations, and
diverse shipping and receiving operations. These commenters supported
the use of independent ``process authorities'' to advise establishments
on cooling carcasses and other raw products. Some suggested that the
proposed chilling requirements should be recast as guidelines.
Many commenters questioned the need for any regulatory requirements
for chilling and asserted that it was conceptually at odds with the
proposed HACCP provisions. They recommended that FSIS defer any
regulation on chilling because establishments would have to address
chilling as part of their HACCP plans.
Some commenters raised concerns about the scientific basis of the
proposed time and temperature requirements. They asserted that the
cooling requirements would not result in any demonstrable improvement
in food safety because they were not based on scientifically valid
data. A number of commenters said that the proposed time and
temperature requirements were simply not achievable by the beef
industry due to the large size of beef carcasses. Also, they said that
these carcass cooling requirements might change meat quality attributes
such as product texture and palatability.
Many commenters asserted that FSIS's regulatory focus and the
economic burdens are placed entirely on establishments when, these
commenters argue, a large proportion of foodborne illnesses are caused
by temperature abuse and other mishandling of raw products after they
leave the establishment.
Many commenters expressed concern about risks to employees' health
that could result from employees working continuously in a colder
environment. They cited worker safety studies showing many human
physical ailments are created or aggravated by cold ambient
temperatures. Worker safety was also cited as an issue on the grounds
that the difficulty of handling and cutting meat at such cold
temperatures increases the potential for accidents and injuries.
Some commenters noted that FSIS did not specify how the equivalence
of alternative procedures could be established. In addition, some
suggested specific alternative methodologies they thought would provide
equivalent procedures, such as cooling with dry ice, CO2, or
nitrogen. Others either did not approve of using any alternative
chilling process or wanted them to be included in the final rule.
Some commenters questioned the rationale for proposing identical
requirements for meat and poultry. They said that using the same set of
requirements for all species fails to take into account the variation
in carcass size.
Commenters from small businesses said they did not have the cooling
capacity to comply with the proposed requirements, and that the cost of
expanding facilities, obtaining the necessary refrigeration equipment,
and retaining quantities of carcasses long enough to chill them to
40 deg.F before shipping was prohibitive.
Other commenters said the time and temperature requirements
conflicted with religious, cultural, and ethnic practices. For example,
there are ethnic markets for ``hot pork,'' whereby hogs are slaughtered
and delivered directly to customers for preparation and consumption
with little or no intervening chilling. A similar process is used with
lamb, goat, and beef for Moslem customers. Some commenters asserted
that the proposed requirements also conflict with and preclude the
Kosher process of ritual salting of poultry.
Commenters also were concerned that carcasses that are processed in
one establishment and shipped to another establishment for immediate
further processing or directly to an off-site cooling facility would
have to meet carcass cooling requirements.
Questions were raised about the disposition of products that did
not meet temperature requirements. Concern was expressed about the
possible condemnation of large quantities of product based on slight
deviations from temperature requirements that would not by themselves
jeopardize food safety.
A number of commenters addressed the proposed shipping temperature
requirements. Many asserted that temperature variation during shipping
is a significant problem. Several commenters asked about their
liability for product after it has left their custody and is found
later, e.g., at a warehouse or retail establishment, to have been
subjected to temperature abuse or other mishandling. Related comments
stated that time and temperature controls were important at all stages
of food production, especially at retail, and should be more of a focus
of FSIS's regulatory oversight.
A few commenters expressed concern about the burden of preparing a
written plan and the proposed recordkeeping requirements.
After reviewing the comments, FSIS agrees that the proposed
regulations on this issue should not be promulgated at this time. FSIS
is persuaded that the complexity and variety of acceptable chilling
practices now in use make the proposed prescriptive time and
temperature requirements unduly burdensome and impractical. FSIS
[[Page 38857]]
intends to seek an alternative that will not conflict with Kosher or
other religious, cultural, or ethnic practices that do not present food
safety hazards to consumers. FSIS has concluded that its food safety
objectives may be achieved more effectively by regulatory means other
than those proposed.
Nevertheless, FSIS continues to believe that prompt, thorough
chilling of carcasses and raw meat and poultry products by slaughtering
establishments is necessary to minimize consumers' exposure to
pathogenic microorganisms. Cooling of carcasses is generally
acknowledged to be an essential component of any establishment's
processing controls for safe food production.
FSIS agrees with those commenters who stated that keeping raw
products cooled after they leave the establishment, during
transportation, storage, distribution, and sale to consumers, is
essential if growth of pathogenic microorganisms on raw products is to
be prevented. This is consistent with FSIS's farm-to-table food safety
strategy.
Instead, FSIS believes that the best way to regulate in this area
would be by having as a performance standard a maximum temperature for
products being shipped into commerce, and at which raw products in
commerce must be maintained. This standard would be applicable to all
persons who handle such product before the product reaches the
consumer. FSIS believes that there are at least two possible
temperatures for this purpose.
A mandatory temperature of 41 deg.F would provide a large margin of
safety against the multiplication of pathogenic bacteria, which
generally will not multiply at temperatures below 50 deg.F. It is
similar to the maximum temperature of 40 deg.F originally proposed by
FSIS and recommended in Agriculture Handbook No. 412. It is also the
same temperature as that specified in the Food and Drug
Administration's current model Food Code which is offered for adoption
by States and other government entities with jurisdiction over food
service, retail food stores and food vending machine operations.
Alternatively, a temperature of 45 deg.F would still provide a
margin of safety and also is that required in FDA's current Good
Manufacturing Regulations for refrigerated foods generally. It also
would comport with the temperature established for raw product in
commerce by the European Union. That temperature is increasingly
accepted as a standard for raw product storage and transportation by
other countries and appears to be an emerging standard for
international trade.
FSIS could supplement the shipping/storage temperature regulations
with guidelines, including recommended criteria for microorganisms,
that would provide purchasers and vendors in commerce additional means
by which to determine whether products bear a level of bacteria
indicative of temperature abuse and, therefore, are likely to bear
levels of pathogenic microorganisms that could be associated with
foodborne illnesses.
FSIS has concluded that development of such a performance standard
requires that it obtain additional information and engage in further
rulemaking. Therefore, FSIS will extend and expand this rulemaking
proceeding on the issue of cooling raw meat and poultry products. FSIS
will consider alternatives to the specific time and temperature
requirements it proposed, including performance standards governing
cooling during transportation and storage of raw meat and poultry,
probably in the form of a maximum temperature for transporting and
holding such product.
As the next step in its proceedings on this topic, FSIS plans to
hold a public conference to gather further information on the many
technical and practical issues raised in the comments as well as on
possible alternatives to the proposal which will be outlined in the
Agency's announcement of the conference.
International Trade
The inspection statutes require that meat and poultry products
imported into the United States be produced under an inspection system
equivalent to the U.S. inspection system.
A large number of commenters requested that FSIS clarify how it
will determine the ``equivalence'' of foreign inspection systems
following HACCP implementation. Commenters questioned exactly how FSIS
will determine foreign system equivalency regarding HACCP systems.
Further, some commenters asserted that requiring foreign equivalency
with the U.S. HACCP system could create problems in foreign trade if
HACCP implementation in the United States causes some foreign
inspection programs previously designated ``equivalent'' to lose that
designation.
Foreign countries with establishments exporting to the United
States must establish inspection system requirements ``equivalent to''
U.S. requirements. This means that all foreign meat and poultry
establishments that export meat to the United States must operate HACCP
systems or process control systems ``equivalent to'' HACCP. They must
also adopt equivalent performance standards.
The components of FSIS's current import inspection system will not
change. As part of the evaluation of the laws, policies, and
administration of the inspection system of any foreign country eligible
to export meat or poultry products into the United States, FSIS will
assess the status of HACCP-- or equivalent process control system-
implementation in that country. This assessment will include on-site
reviews of individual establishments, laboratories, and other
facilities within the foreign system. The ``equivalency'' of foreign
inspection will be determined at this stage.
Further, when these regulations are implemented, the import
inspection system will continue to include port-of-entry inspection by
FSIS inspectors to verify the effectiveness of foreign inspection
systems. All countries exporting raw products to the United States must
develop and implement performance standards that are equivalent to the
pathogen reduction performance standards for Salmonella. They must also
be able to demonstrate that they have systems in place to assure
compliance with the standards.
As of January 1, 1995, 1,395 establishments in 36 countries were
certified to export meat or poultry products to the United States.
Canada, with 599 establishments; Denmark, with 125; Australia, with 111
establishments; and New Zealand, with 94 establishments, accounted for
two-thirds of those, which were collectively the source of 85 percent
of the 2.6 billion pounds of product imported into the United States
during 1994. Canada, Denmark, Australia, and New Zealand are currently
developing HACCP systems.
Most of the comments concerning the impact on exports dealt with
the proposed requirement for antimicrobial treatment of U.S. product
and the proposed exemption for exported product. That proposed
requirement raised particular concerns because the European Union
member states and Canada restrict the use of certain antimicrobials on
meat and poultry carcasses.
A number of commenters cited the fact that a proposed exemption
would be ineffective because establishments cannot segregate treated
product from untreated product. Commenters said this occurs because
antimicrobial treatments are performed on whole carcasses, while most
meat and poultry is exported in parts. This condition, the commenters
argued, would cause
[[Page 38858]]
significant operational difficulty to establishments that were required
to separate product that had and had not been treated, as well as
inventory management problems. This requirement might also result in an
artificial trade barrier with countries such as Canada, which restrict
use of certain antimicrobial treatments. Suggestions were made that
FSIS should obtain Codex support and acceptance for the proposed
antimicrobial interventions as a means to overcome international
objections to their use. The Agency's decision not to mandate
antimicrobial treatments largely negates these concerns. FSIS will
continue to work within Codex and in its bilateral relations with major
trading partners to ensure that the scientific basis for food safety
practices in the U.S. are understood and accepted.
The final rule will affect U.S. exports only if an establishment
has difficulty meeting the new microbial performance standards without
using an antimicrobial treatment. FSIS is aware that alternative
technologies now available can facilitate international trade. For
example, public comments indicated that trisodium phosphate is approved
for use in Canada and the United Kingdom, and is being considered by
the European Union, Australia, and New Zealand. Steam vacuum systems
constitute an improved technology for establishments exporting beef and
pork products.
Recordkeeping and Record Retention
FSIS notes that recordkeeping requirements and record retention
periods for sanitation SOP's, microbiological testing, and HACCP are
found in 416.12, 310.25(b)(4), and 381.94(b)(4), and 417.5,
respectively. The proposed amendments to sections 320.1, 320.3,
381.175, and 381.177 were intended to continue FSIS' practice of cross-
referencing recordkeeping requirements in Secs. 320.1, 320.3, 381.175,
and 381.177. FSIS has determined that it is unnecessary to amend these
sections at this time, especially in view of its ongoing efforts to
simplify, consolidate, and streamline the meat and poultry inspection
regulations.
Finished Product Standards for Poultry Carcasses
FSIS proposed to remove the feces nonconformance specification from
the poultry finished product standards regulations (Sec. 381.76, Table
1). That change in the poultry products inspection regulations is being
effected not in this final rule but in the forthcoming final rule,
``Enhanced Poultry Inspection; Revision of Finished Product Standards
with Respect to Fecal Contamination,'' Docket No. 94-016F.
VI. Economic Impact Analysis and Executive Orders
Executive Order 12866
This rule has been determined to be economically significant and
was reviewed by OMB under Executive Order 12866.
HACCP-based Regulatory Program Produces Net Benefit to Society
FSIS has prepared a Final Regulatory Impact Assessment (FRIA) that
evaluates the costs and benefits of a mandatory HACCP-based program for
all meat and poultry establishments under inspection. The FRIA
concludes that mandating HACCP systems will lead to potential benefits
that far exceed industry implementation and operating costs.
The 20-year industry costs of implementing the HACCP-based
regulatory program are estimated to be $968 to $1,156 million. The 20-
year costs to the government are estimated at $56.5 million. FSIS
estimated that the proposed rule would have 20-year costs of $2.2
billion dollars. The costs from the Preliminary Regulatory Impact
Analysis (PRIA) are not directly comparable to costs estimated for the
final rule. The proposed rule had a larger number of explicit
regulatory requirements. The PRIA focused on estimating the predictable
costs of meeting those requirements and included an implicit assumption
that compliance with the proposed requirements would assure compliance
with pathogen reduction objectives. In contrast, the final rule allows
for greater flexibility in meeting the pathogen reduction standards,
but also outlines a more rigorous enforcement strategy. Thus for the
FRIA, it was necessary to develop separate cost estimates for the
potential costs of meeting the new pathogen reduction performance
standards for Salmonella. Modifications incorporated into the final
rule have both reduced the total estimated costs and redistributed
costs in a way that reduces the relative burden on smaller
establishments.
Both the preliminary and final analysis identify a potential public
health benefit of $7.13 to $26.59 billion, tied to eliminating the
contamination by four pathogens that now occurs in meat and poultry
establishments. These four pathogens include the three most common
enteric pathogens of animal origin: Campylobacter jejuni/coli, E. coli
O157:H7, Salmonella and one environmental pathogen Listeria
monocytogenes. The potential benefit estimate is tied to the
minimization of risk from the 90 percent of these pathogens that are
estimated to contaminate meat and poultry during slaughter and dressing
procedures. The remaining 10 percent of contamination is estimated to
occur after the product leaves the manufacturing sector. The link
between regulatory effectiveness, where effectiveness refers to the
percentage of pathogens eliminated at the manufacturing stage, and
health benefits is the assumption that a reduction in pathogens leads
to a proportional reduction in foodborne illness. The high and low
range for potential benefits occurs because of the current uncertainty
in the estimates of the number of cases of foodborne illness and death
attributable to pathogens that enter the meat and poultry supply at the
manufacturing stage.
The benefits analysis in the FRIA concludes that there is
insufficient knowledge to predict with certainty the effectiveness of
the rule, where effectiveness refers to the percentage of pathogens
eliminated at the manufacturing stage. Without specific predictions of
effectiveness, FSIS has calculated projected health benefits for a
range of effectiveness levels. For example, if the HACCP-based program
can reduce the four pathogens by 50 percent and that reduction leads to
a proportionate reduction in foodborne illness, the projected benefits
range from $3.6 to $13.3 billion, which is half the potential benefit
estimate of $7.13 to $26.59 billion.
If the low potential benefit estimate is correct, the analysis
shows that the new HACCP-based program must reduce pathogens by 15 to
17 percent before benefits outweigh projected costs. If the high
estimate is the correct estimate, the new program needs to reduce
pathogens by only 4 to 5 percent to generate net societal benefits.
While there were a large number of comments relating to the
effectiveness estimates in the PRIA, there were no comments that
claimed or implied that HACCP would not reduce pathogens at levels
necessary to produce net societal benefits. The requirements of the
final rule are organized around the following three components:
The requirement that all inspected establishments
develop and implement HACCP programs based on the seven recognized
principles of HACCP.
The requirement that all inspected establishments
develop and implement Sanitation SOP's.
The requirements that all establishments that slaughter
cattle, swine, chickens or turkeys implement a microbial sampling
[[Page 38859]]
program using E. coli (generic) as a measure of control of slaughter
and sanitary dressing procedures and that all establishments that
slaughter cattle, swine, chickens or turkeys or produce raw ground
product from these animals or birds meet new pathogen reduction
performance standards for Salmonella.
The proposal and final rule can be viewed as two scenarios for
implementing a mandatory HACCP-based regulatory program. While it's not
possible to compare the benefits of these two options, the FRIA does
present a comparison of the costs.
Table 5 summarizes the estimated costs for both the proposal and
final rule by individual regulatory component. As mentioned above, the
costs are not directly comparable because the regulatory components
have changed. Table 5 shows that all costs have been eliminated for the
components of time-and-temperature requirements and antimicrobial
treatments. However, the discussion of potential costs in the FRIA
recognizes that some establishments may use antimicrobial treatments to
help meet the pathogen reduction performance standards for Salmonella.
Other establishments may impose temperature limits to help control
Salmonella growth.
Table 5 includes the final cost estimate for generic E. coli
sampling in slaughter establishments under the regulatory component for
microbial testing. The costs for required microbial sampling have
decreased substantially from the proposal.
In the FRIA, FSIS increased or added a cost estimate for four
regulatory components. First, based on comments, FSIS added costs for
recurring training to account for the fact that employee turnover will
sometimes require establishments to train additional employees. Second,
FSIS also added a minimal cost for annual reassessment of HACCP plans,
although the Agency believes that reassessment will be negligible for
establishments successfully operating HACCP systems. Third, FSIS has
increased the estimated cost for HACCP plan development. The estimate
for this cost was increased after reviewing public comments and
assessing the overall impact on plan development costs of decisions to
eliminate time-and-temperature and antimicrobial treatment requirements
prior to HACCP implementation. Finally, the Agency recognizes that some
establishments will have difficulty meeting the new performance
standards for Salmonella and that implementing sanitation SOP's and
HACCP plans will not always assure sufficient pathogen reduction. The
FRIA has developed two scenarios that lead to low and high cost
estimates related to potential actions that establishments might
undertake. Such actions include both process modifications to reduce
pathogens and the implementation of Salmonella testing programs to
assure compliance with the new performance standards.
As shown in Table 5, the two scenarios developed in the FRIA lead
to a range in cost estimates of $55.5 to $243.5 million to comply with
the new pathogen reduction standards for Salmonella. The FRIA
recognizes that the performance criteria for generic E. coli also
create a set of potential costs for slaughter establishments. A line
for these costs is shown in Table 5 along with the entry that these
costs were not separately quantified.
As discussed in the FRIA, the anticipated actions to comply with
the generic E. coli criteria are the same as the anticipated actions to
comply with the standards for Salmonella. FSIS has concluded that if
the low cost scenario for Salmonella compliance proves to be more
accurate, than the Agency would expect to see some compliance costs for
the generic E. coli performance criteria. If the high cost scenario is
correct, then the compliance actions taken to assure compliance with
the Salmonella standards should also assure compliance with the generic
E. coli criteria.
Table 5.--Comparison of Costs--Proposal to Final
[$ Millions--Present value of 20-year costs]
----------------------------------------------------------------------------------------------------------------
Regulatory component Proposal Final
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's.............. 175.9a................................ 171.9
II. Time/Temperature Requirements 45.5.................................. 0.0
III. Antimicrobial Treatments.... 51.7.................................. 0.0
IV. Micro Testing................ 1,396.3b.............................. 174.1
V. Compliance With Salmonella Not Separately Estimatedc............. 55.5-243.5
Standards.
Compliance with generic E. Not Applicable........................ Not Separately Estimated
coli criteria.
VI. HACCP
Plan Development............. 35.7.................................. 54.8
Annual Plan Reassessment..... 0.0................................... 8.9
Recordkeeping (Recording, 456.4................................. 440.5d
Reviewing and Storing Data).
Initial Training............. 24.2.................................. 22.7d
Recurring Training........... 0.0................................... 22.1e
VII. Additional Overtime......... 20.9.................................. 17.5d
==============================================================================
Subtotal--Industry Costs... 2,206.6............................... 968.0-1,156.0
VIII. FSIS Costs................. 28.6f................................. 56.5
------------------------------------------------------------------------------
Total...................... 2,235.2............................... 1,024.5-1,212.5
----------------------------------------------------------------------------------------------------------------
a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted
because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days
after publication.
b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat
and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and
raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the
proposed sampling requirements.
c The preliminary analysis accounted for some of the cost of complying with the new standards under the
regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.
d These costs are slightly different from the proposal because of changes in the implementation schedule.
e FSIS added costs for recurring training based on the review of public comments.
f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP
verification testing.
[[Page 38860]]
Market Failure Justifies Regulation of Pathogens
Since all raw meat and poultry products contain microorganisms that
may be pathogens, raw food unavoidably entails some risk to consumers
of pathogen-exposure and foodborne illness. The presence and level of
this risk cannot be determined by a consumer since pathogens are not
visible to the naked eye. The societal impact of this food safety
information deficit is a lack of accountability for foodborne illnesses
caused by pathogenic microorganisms. Consumers often cannot trace a
transitory illness to any particular food or even be certain it was
caused by food. Thus, food retailers and restaurateurs are generally
not held accountable by their customers for selling pathogen-
contaminated products and they, in turn, do not hold their wholesale
suppliers accountable either.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen controls. The
widespread lack of information about pathogen sources means that
business at every level from farm to final sale can market unsafe
products and not suffer legal consequences or a reduced demand for
their product.
The science and technology required to reduce meat and poultry
pathogens is well established, readily available, and commercially
practical. FSIS has concluded that the lack of consumer information
about meat and poultry product safety and the absence of adequate
incentives for industry to provide more than minimal levels of
processing safety represents a market failure requiring Federal
regulatory intervention. The present combination of market regulation
and industry self-policing has not resolved increasingly apparent
problems with meat and poultry pathogens. Documented cases of foodborne
illness each year, some of which have resulted in death, represent a
public health risk that FSIS has determined to be unacceptable. A
comprehensive Federal regulatory program is the only means available to
society for lowering foodborne pathogen risks to an acceptable level.
FSIS further concludes that a mandatory HACCP regulatory program is the
only means to attain this goal.
Regulatory Alternatives
After considering broader regulatory approaches including market
incentives and voluntary industry standards, FSIS has determined that
effective process control is needed throughout the meat and poultry
industry in order to minimize pathogen contamination of food products
and lower the risk of subsequent foodborne illness.
FSIS examined the following seven process control approaches before
determining that mandatory HACCP was the most effective means for
industry to eliminate pathogens in meat and poultry:
Status quo
Intensify present inspection
Voluntary HACCP regulatory program
Mandatory HACCP regulation with exemption for small
businesses
Mandatory HACCP regulation only for ready-to-eat products
Modified HACCP--negative records only
Mandatory HACCP for all establishments
Each of these seven alternatives was assessed using the following
five effectiveness factors for process control:
Controls production safety hazards
Reduces foodborne illness
Makes inspection more effective
Increases consumer confidence
Provides the opportunity for increased productivity
Only mandatory HACCP for all establishments was determined to meet
all five criteria; all of the others were found to be flawed in meeting
one or more of the target factors.
The full text of the Final Regulatory Impact Analysis is published
as a supplement to this document.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act (P.L. 104-4) requires (in Section
202) that agencies prepare an assessment of anticipated costs and
benefits before proposing any rule that may result in annual
expenditures by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000, (adjusted annually for
inflation). The preliminary and final RIA's fulfill this requirement of
the Unfunded Mandates Reform Act. FSIS has treated both the proposed
rule and this final rule as an economically significant regulatory
action, i.e., annual cost to the private sector of more than
$100,000,000, under Executive Order 12866 and has prepared a final
Regulatory Impact Analysis (RIA) in compliance with the provisions of
Executive Order 12866. The final RIA identifies annual recurring
private sector costs of from $99.6 to $119.8 million and potential
annual public health benefits of $.99 to $3.69 billion.
The Act also requires (in Section 205) that the Agency identify and
consider a reasonable number of regulatory alternatives and, from these
alternatives, select the least costly, most cost-effective, or least
burdensome alternative that achieves the objective of the rule. In the
final RIA, FSIS considered several broad regulatory alternatives and
selected the one that is both cost-effective and also the least
burdensome alternative that achieves the food safety objectives of the
rule. FSIS concluded that market incentives will not address the public
health risk resulting from microbial pathogens in meat and poultry,
primarily because there is rarely feedback to consumers that allows
more informed purchase decisions nor is there feedback which would
permit consumers who experience a foodborne illness to routinely, and
at low cost, seek compensation from responsible parties for losses
arising from their foodborne illness. Thus, market solutions would not
adequately address the food safety objectives on the rule. FSIS
concluded that an industry administered system of voluntary standards
is likely to be more expensive and less effective than a governmental
one. Finally, FSIS has recognized that public education is essential
for assuring food safety, but experience has shown that education alone
has limited effectiveness in reducing foodborne illness. Thus, while
consumer education may be cost-effective it would not meet the
objective of substantially reducing foodborne illness.
Based on a qualitative analysis of broad regulatory strategies, the
final RIA concluded that mandatory government standards were needed to
achieve a solution that is both cost-effective and meets the objective
of reducing the risk of foodborne illness from meat and poultry. Within
the framework of a mandatory regulatory program, the final RIA
discusses several alternatives to a mandatory HACCP-based program for
all inspected establishments including intensified inspection,
mandatory HACCP with a small business exemption and mandatory HACCP for
only ready-to-eat products. These alternatives were evaluated using
several criteria incorporating the goals of effectiveness, efficiency
and increased consumer confidence. Using these criteria FSIS concluded
that HACCP systems designed to meet microbial performance standards
will be both cost-effective and the least burdensome alternative for
meeting the foodborne illness reduction objectives of the rule. As the
final RIA points out, requiring mandatory process control without
microbial performance
[[Page 38861]]
standards could lead to processes that are well controlled at
unacceptable pathogen levels. FSIS believes that microbial performance
standards are necessary to achieve substantial pathogen reduction,
encourage industry innovation, and provide the impetus for continuing
improvement and increasing effectiveness.
Consistent with the requirements in Section 204 to provide
opportunity for input from State, local and tribal government
officials, FSIS held a ``Federal-State-Relations Conference,'' August
21-23, 1995, in Washington, D.C. This meeting, in which the National
Association of State Departments of Agriculture participated, provided
an opportunity for representatives from State government to engage in
an open exchange with senior USDA officials on the Pathogen Reduction/
HACCP proposal. In addition to Directors of State meat and poultry
inspection programs, the meeting included representatives from State
Departments of Agriculture, State Health Departments and local food
safety enforcement agencies.
Also related to the Section 204 requirements, on May 22, 1995 the
Agency held a public meeting for owners and representatives of small
meat and poultry establishments and other affected small businesses to
discuss the pathogen Reduction/HACCP proposal. Three Directors of State
meat and poultry inspection programs provided comments at the meeting.
Section 202 of the Act also requires a summary and evaluation of
comments received from State, local, or tribal governments. There were
a large number of comments from State and local governments, elected
members of State legislatures and associations representing State
programs or businesses within States. Collectively, these comments
covered most, if not all, of the issues addressed as part of this final
rule. This preamble and the final RIA represent a summary and
evaluation of these comments.
Most of the comments from State, local, or tribal governments
addressed the potential economic impact on small businesses. The Kansas
City meeting was intentionally focused on the small business issues.
Comments from the State program Directors included recommendations for
various forms of exemptions, voluntary programs or financial assistance
for small State inspected establishments. The Federal-State-Relations-
Conference included a more focused discussion on the cost to the State
programs. Attendees stated that FSIS failed to adequately consider the
cost of the changes to State programs and that FSIS was increasing the
resource demands for State programs without providing adequate funding.
There were also written comments stating that the proposed rule was
an unfunded Federal mandate because of the cost to small establishments
and the potential impact on State inspection programs. The preliminary
RIA did not address the impact on State programs. However, FSIS
recognizes that the 27 States operating their own meat and poultry
inspection programs will likely have to substantially modify their
programs after the HACCP/Pathogen Reduction regulation is finalized to
remain ``at least equal to'' Federal inspection programs as required by
the FMIA and PPIA. During the regulation's implementation period, FSIS
will be using the Agency's State-Federal Program resources to assist
the States in bringing the necessary changes to the State inspection
programs. Although FSIS has requested some additional funds to
implement this rule, FSIS has also acknowledged that implementation of
this rule will require eliminating some tasks, conducting other tasks
differently and streamlining the organization in order to free up
resources to fully address the new requirements. FSIS believes that the
same type of restructuring or reprogramming will take place within the
State programs. This does guarantee, however, that all States with
inspection programs will be able to implement the necessary program
changes without additional funds. FSIS believes, however, that with
FSIS assistance and with the flexibility provided under the ``equal
to'' provisions, most of the States should be able to modify their
programs with minimal additional costs. To the extent that there are
any additional costs, the State inspection programs are eligible to
receive up to 50 percent Federal matching funds.
Regulatory Flexibility Act
The Administrator, FSIS, has determined that this rule will have a
significant economic impact on a substantial number of small entities.
This final rule uses two size criteria for providing regulatory
flexibility for small entities. For livestock and poultry slaughter
facilities, the microbial sampling requirements vary depending on the
number of animals or birds slaughtered annually. This will
significantly reduce the microbial testing costs for smaller
establishments which, under the proposed rule, would have been required
to test each species they slaughter every day on which slaughter of
that species occurred. Under the final rule, establishments that
annually slaughter fewer than 6,000 cattle, 20,000 swine (or a
combination of such livestock not to exceed a total of 20,000, with a
maximum of 6,000 cattle), 60,000 turkeys or 440,000 chickens (or a
combination of chickens and turkeys not to exceed 60,000 turkeys or
440,000 birds total) will not be required to operate microbial sampling
programs on a continuous basis. Over 78 percent (2,098) of the total
2,682 slaughter establishments meet these criteria. These
establishments will be required to annually verify that their slaughter
and sanitary dressing processes are under control. However, after an
initial period of sampling in each year, these establishments will be
required to conduct further sampling in that year only if they make
major changes to facilities, equipment, and personnel whereby the
slaughter and dressing process is significantly changed.
These low-volume establishments will be required to analyze one
sample per week until they have demonstrated compliance with
established criteria. At a minimum, low-volume slaughter establishments
will be required to collect and analyze one sample per week until they
complete a sampling window (13 samples) annually in order to assess
whether the performance criteria continue to be met.
Small slaughter establishments that process only minor species
(e.g., goats, sheep, ducks, pheasants, etc.) will not be required to
conduct any sampling. Small slaughter establishments will also face
less burden because the final rule no longer requires that both cattle
and swine or chickens and turkeys be sampled in the same establishment,
i.e., if a low-volume establishment slaughters both cattle and swine or
turkeys and chickens, it will be required to analyze one sample per
week from the predominant species until it has demonstrated compliance
with established criteria. The costs of small slaughter establishments
are also reduced because the carcass cooling and antimicrobial near-
term requirements have been eliminated from the final rule. Sampling
frequencies for even the larger slaughter establishments will be based
on production-volume, thus spreading the cost per pound relatively
equally among establishments.
For the purpose of sequencing HACCP implementation FSIS has defined
a small entity using the Small Business Administration size standard
for a small meat or poultry manufacturing establishment. That is, all
establishments with fewer than 500 employees will have additional time
to implement HACCP. In addition, in
[[Page 38862]]
response to comments that there are hundreds of ``very small'' or
``micro'' establishments, the Agency will classify an establishment as
``very small'' if it has either fewer than 10 employees or annual sales
of less than $2.5 million. This sequencing of HACCP responds to a large
number of comments requesting that small businesses be given a longer
period of time to implement HACCP requirements. Many small businesses
stated they did not want to be exempt, but asked for more flexibility
in implementing HACCP.
The FRIA is based on 353 large firms implementing HACCP at 18
months, 2,941 small firms implementing HACCP at 30 months and 5,785
very small (2,892 Federal plus 2,893 State) firms implementing HACCP at
42 months.
Table 6 illustrates the costs for a small, single-shift, processing
establishment (no TQC or sanitation PQC program) with two distinct
production operations other than raw ground product (overall average
estimated at 2.29 operations per establishment).
Table 6.--Costs for Typical Single-Shift Processing Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's........................... 190 1,242
HACCP Plan Development..................... 6,958 0
Annual Plan Reassessment................... 0 102
Training................................... 2,514 251
Recordkeeping.............................. 0 6,480
----------------------------
Total................................ 9,662 8,075
------------------------------------------------------------------------
If one of the two production operations produced a raw ground
product, the establishment would have to meet the pathogen reduction
performance standard for that product. The FRIA points out that raw
ground operations do not have the same opportunities to reduce
Salmonella levels as do slaughter establishments. They can control
growth by avoiding temperature abuse and can limit cross-contamination,
but basically they must depend on the Salmonella levels of their
incoming product in order to meet the performance standards. These
establishments may choose to test incoming product in order to
eliminate suppliers whose product is found to be positive. The FRIA has
assumed that the low volume producers would not test incoming
ingredients.
Table 7 illustrates the costs for a small, single-shift,
combination (slaughter and further processing) establishment that
slaughters cattle or swine, but not both, and has a single further
processing operation other than ground product. The establishment is
not under TQC inspection.
The cost of meeting the pathogen reduction performance standards
assumes that the establishment will use a hot water antimicrobial rinse
and have one sample per month analyzed at an outside laboratory ($33.35
per sample-$400 per year). The average number of head slaughtered in a
low volume establishment is approximately 5,000 annually. The annual
cost for the rinse is $400.
Table 7.--Costs for Typical Single-Shift Combination Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's........................... 190 1,242
Compliance with Salmonella Standards....... 0 800
E. coli Sampling........................... 1,043 653
HACCP Plan Development..................... 6,958 0
Annual Plan Reassessment................... 0 102
Training................................... 5,028 503
Recordkeeping.............................. 0 5,434
----------------------------
Total................................ 13,219 8,734
------------------------------------------------------------------------
The development costs for E. coli sampling in the small
establishment includes $640 for developing a sampling plan and $403 to
train an individual to conduct aseptic sampling. The recurring costs
are based on the assumption that an average low volume slaughter
establishment will have to complete two sampling windows (26 samples)
before they demonstrate compliance with established criteria.
The cost of HACCP training has doubled for the combination
establishment because the FRIA assumed that slaughter and processing
operations are significantly different, so that the establishment must
either train two employees or send one employee to two separate
training courses.
The HACCP recordkeeping costs (monitoring CCPs and recording
findings, reviewing records and storing records) in the above two
examples assume that the establishments are operating each process
continuously over a standard 52-week, 260-day, 2,080-hour work year.
Data collected during the preliminary analysis indicates that many low-
volume establishments frequently have only a single production line
operating at a given time. The final analysis estimates an average
annual cost for HACCP monitoring and recording of $4,030 for low-volume
establishments.
Executive Order 12778
This rule has been reviewed pursuant to Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the FMIA and PPIA from imposing any requirements with respect to
federally inspected premises and facilities, and operations of such
establishments, that are in addition to, or different from, those
imposed under the FMIA and PPIA. States and local jurisdictions may,
however, exercise concurrent jurisdiction over meat and poultry
products that are outside official establishments for the purpose of
preventing the distribution of meat or poultry products that are
misbranded or adulterated under the FMIA or PPIA, or, in the case of
imported articles, which are not at such an establishment, after their
entry into the United States. Under the FMIA and PPIA, States that
maintain meat and poultry inspection programs must impose requirements
on State-inspected products and establishments that are at least equal
to those required under the FMIA and the PPIA. These States may,
however, impose more stringent requirements on such State-inspected
products and establishments.
Paperwork Requirements
The paperwork and recordkeeping for this rule are approved under
OMB number 0583-0103, ``Pathogen Reduction, Hazard Analysis and
Critical Control Points (HACCP) Systems.'' OMB approved 14,371,901
annual reporting hours. Overall, the burden hours associated with the
rule decreased. FSIS determined that the new burden is 8,053,319 hours,
a 6,318,582-hour reduction. This reduction resulted from the
elimination of proposed requirements and the adjustment of certain
burden hour estimations. The following discusses the finalized
paperwork and recordkeeping requirements and the changes in the burden
estimations.
Sanitation Standard Operating Procedures (Sanitation SOP's)
As part of establishments' sanitation requirements, each
establishment must develop and maintain Sanitation SOP's that must, at
a minimum, address core
[[Page 38863]]
sanitation procedures. As part of the Sanitation SOP's, establishment
employees(s) must record results of daily sanitation checks on a
checklist at the frequencies stated in the Sanitation SOP's. The
checklist must include both preoperational sanitation checks and
operational sanitation checks. This checklist must be made available to
FSIS upon request.
Agency subject matter experts and private consultants estimate that
it will take an average of 5, 10, and 25 hours to develop a sanitation
program for low, medium, and high volume establishments, respectively.
The burden of documenting the adherence to Sanitation SOP's is based on
three factors; recording, reviewing, and storage. Recording encompasses
conducting and inscribing the finding from an observation and filing of
the document produced. This action is assumed to take 15, 25, and 45
minutes per day in a low-, medium-, and high- volume establishment,
respectively. Review of the records generated is estimated to take 5,
10, and 20 minutes per day for a low-, medium-, and high-volume
establishment, respectively.
OMB approved 1,243,622 burden hours for Sanitation SOP's plan
development, recording and filing, and record review. FSIS determined
that the burden estimate for these activities was too high. Based on
more accurate data, FSIS reevaluated the burden estimate and calculated
the new burden hours to be 1,231,986 hours. This is a 11,636 burden
hour decrease.
Time and Temperature
As discussed earlier, the proposed time-and-temperature
requirements are eliminated. OMB approved 869,156 burden hours for
time-and-temperature requirements. Therefore, elimination of the time-
and-temperature requirements, results in a 869,156 burden hour
decrease.
Microbiological Testing
As part of microbiological testing, each slaughter establishment
must develop written procedures outlining specimen collection and
handling. The slaughter establishments will be responsible for entering
the results into a statistical process control chart or table. The data
and chart will be available for review by FSIS upon request.
Agency subject matter experts estimate that it will take 25 hours
for establishments to develop a microbial sampling and analysis plan.
It will take an estimated 17.5 minutes to collect samples and 5 minutes
per sample to enter data into the chart, review, and file the
information.
OMB has approved 1,177,924 burden hours for microbial testing plan
development, sample collection, and data entry by meat and poultry
establishments. As discussed earlier, the number of meat and poultry
establishments required by the Pathogen Reduction/HACCP proposal to
perform microbial testing and the number of tests required decreased.
FSIS reevaluated this burden estimate and concluded that the burden for
microbial testing by meat and poultry establishments is 468,061 burden
hours. Therefore, the burden hour decrease associated with microbial
testing is 709,863 hours.
HACCP
Establishments will develop written HACCP plans that include:
identification of the food safety hazards reasonably likely to occur;
identification and description of the critical control point for each
identified hazard; specification of the critical limit that may not be
exceeded at the CCP; description of the monitoring procedure or device
to be used; description of the corrective action to be taken if the
limit is exceeded; description of the records that will be generated
and maintained regarding this CCP; and description of the establishment
verification activities and the frequency at which they are to be
conducted. Performance standards or limits specified in related FSIS
regulations must be accounted for in the critical limits.
Establishments will keep records of measurements taken during
slaughter and processing, corrective actions, verification check
results, and related activities that contain the identity of the
product, the product code or slaughter production lot, and the date the
record was made. The record will be signed by the operator or observer.
The HACCP records will be reviewed by an establishment employee
other than the one who produced the record, if practicable, before the
product is distributed in commerce. If a HACCP-trained individual is
on-site, that person should be the second reviewer. The reviewer will
sign the records.
Although the amount of time to develop a plan for each process
varies based on its difficulty, Agency subject matter experts estimate
that low, medium, high volume and state establishments will need an
average of 136, 126, 113, and 78 hours to develop each plan. There are
an estimated 7.4 CCP's for each processing plan in Federal
establishments, 5 CCP's for each slaughter plan in Federal
establishments, and 5 CCP's for both types of plans in State slaughter
establishments. The recording and filing is assessed to take 5 minutes
per CCP and the review should take 2 minutes per CCP.
OMB approved 11,081,199 burden hours for the maintenance of the
HACCP-trained individual's resume, plan development, recording, and
record review. As discussed earlier, FSIS will not require personnel
resumes to be maintained, thus the burden reported for this activity is
eliminated. Also, FSIS determined that the burden estimate for plan
development, recording, and record review was too high. Based on more
accurate data, FSIS reevaluated the burden estimate and calculated the
new burden hours to be 6,353,272. This is a 4,727,927 burden hour
decrease.
To better illuminate the burden hour changes, the following table
is provided.
Table 8.--Changes in Burden Hours
----------------------------------------------------------------------------------------------------------------
Burden hours
Requirement approved by New burden Reduction in
OMB hours burden hours
----------------------------------------------------------------------------------------------------------------
SOP's for Sanitation............................................ 1,243,622 1,231,986 11,636
Time and Temperature............................................ 869,156 0.00 869,156
Microbiological Testing......................................... 1,177,924 468,061 709,863
HACCP........................................................... 11,081,199 6,353,272 4,727,927
-----------------------------------------------
Total (Hours)............................................. 14,371,901 8,053,319 6,318,582
----------------------------------------------------------------------------------------------------------------
[[Page 38864]]
The changes in the paperwork and recordkeeping requirements
contained in this rule have been submitted to the Office of Management
and Budget for approval under the Paperwork Reduction Act (44 U.S.C.
3501 et seq.).
VII. Final Rules
List of Subjects
9 CFR Part 304
Meat inspection.
9 CFR Part 308
Meat inspection.
9 CFR Part 310
Meat inspection, Microbial testing.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 327
Imports.
9 CFR Part 381
Poultry and Poultry products, Microbial testing.
9 CFR Part 416
Sanitation.
9 CFR Part 417
Hazard Analysis and Critical Control Point (HACCP) Systems.
For reasons set forth in the preamble, 9 CFR chapter III is amended
as follows:
PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF
INSPECTION
1. The authority citation for part 304 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Section 304.3 is added to read as follows:
Sec. 304.3 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, as
required by part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, as required by Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
PART 308--SANITATION
3. The authority citation for part 308 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
4. Section 308.3 is amended by adding a sentence to the end of
paragraph (a) to read as follows:
Sec. 308.3 Establishments; sanitary condition; requirements.
(a) * * *. The provisions of part 416 of this chapter also apply.
* * * * *
PART 310--POST MORTEM INSPECTION
5. The authority citation for part 310 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
6. Part 310 is amended by adding a new Sec. 310.25 to read as
follows:
Sec. 310.25 Contamination with microorganisms; pathogen reduction
performance standards for Salmonella.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters cattle and/or hogs
shall test for Escherichia coli Biotype I (E. coli) and shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees
designated to collect samples, and shall address location(s) of
sampling, how sampling randomness is achieved, and handling of the
sample to ensure sample integrity. The written procedure shall be made
available to FSIS upon request.
(ii) Sample collection. The establishment shall collect random
samples from carcasses in the cooler. Samples shall be collected by
sponging three sites on the selected carcass. On cattle carcasses,
establishments shall take samples from the flank, brisket, and rump; on
swine carcasses, establishments shall take samples from the ham, belly,
and jowl areas. 1
---------------------------------------------------------------------------
\1\ A copy of FSIS's ``Guidelines for E. coli Testing for
Process Control verification in Cattle and Swine Slaughter
Establishments'' is available for inspection in the FSIS Docket
Room.
---------------------------------------------------------------------------
(iii) Sampling frequency. Samples shall be taken at a frequency
proportional to a slaughter establishment's volume of production, at
the following rates:
Bovines: 1 test per 300 carcasses
Swine: 1 test per 1,000 carcasses
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
(v) Sampling in very low volume establishments.
(A) An establishment annually slaughtering no more than 6,000
bovines, 20,000 swine, or a combination of bovines and swine not
exceeding 6,000 bovines and 20,000 animals total, shall collect one
sample per week starting the first full week of June and continuing
through August of each year. An establishment slaughtering both species
shall collect samples from the species it slaughters in larger numbers.
Weekly samples shall be collected and tested until the establishment
has completed and recorded one series of 13 tests that meets the
criteria shown in Table 1 of paragraph (a)(5) of this section.
(B) Upon the establishment's meeting requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or FSIS.
FSIS determinations that changes have been made requiring resumption of
weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for
[[Page 38865]]
analysis of E. coli that is approved by the Association of Official
Analytic Chemists International 2 or approved by a scientific body
in collaborative trials against the three tube Most Probable Number
(MPN) method and agreeing with the 95 percent upper and lower
confidence limit of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the ``Official Methods of Analysis of the
Association of Official Analytical Chemists International,'' 16th
edition, 1995, is on file with the Director, Office of the Federal
Register, and may be purchased from the Association of Official
Analytical Chemists International, Inc., 481 North Frederick Ave.,
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of cfu/cm\2\ of surface
area sponged. Results shall be recorded onto a process control chart or
table showing at least the most recent 13 test results, by class of
livestock slaughtered, permitting evaluation of the laboratory results
in accordance with the criteria set forth in paragraph (a)(5) of this
section. Records shall be retained at the establishment for a period of
12 months and shall be made available to FSIS upon request.
(5) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels above (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. coli Test Results
Maximum
Number of number
Slaughter class Lower limit of marginal Upper limit of marginal samples permitted
range range tested in marginal
range
(m)........................ (M)....................... (n) (c)
----------------------------------------------------------------------------------------------------------------
Steers/heifers............... Negative a................. 100 cfu/cm\2\............. 13 3
Cows/bulls................... Negative a................. 100 cfu/cm\2\............. 13 3
Market hogs.................. 10 cfu/cm\2\............... 10,000 cfu/cm\2\.......... 13 3
a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
at least 5 cfu/cm\2\ carcass surface area.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection shall be suspended in
accordance with rules of practice that will be adopted for such
proceedings upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standard; Salmonella.
(1) Raw meat product performance standards for Salmonella. An
establishment's raw meat products, when sampled and tested by FSIS for
Salmonella, as set forth in this section, may not test positive for
Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
------------------------------------------------------------------------
Maximum
Performance number of
Standard Number of positives
Class of product (percent samples to achieve
positive for tested (n) Standard
Salmonella)a (c)
------------------------------------------------------------------------
Steers/heifers.................. 1.0% 82 1
Cows/bulls...................... 2.7% 58 2
Ground beef..................... 7.5% 53 5
Hogs............................ 8.7% 55 6
Fresh pork sausages............. bN.A. N.A. N.A.
------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national
prevalence of Salmonella on the indicated raw product based on data
developed by FSIS in its nationwide microbiological data collection
programs and surveys. Copies of Reports on FSIS's Nationwide
Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of
Salmonella on raw products are available in the FSIS Docket Room.
b Not available; values for fresh pork sausage will be added upon
completion data collection programs for those products.
(2) Enforcement. FSIS will sample and test raw meat products in an
individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.3
---------------------------------------------------------------------------
\3\ A copy of FSIS's ``Sample Collection Guidelines and
Procedure for Isolation and Identification of Salmonella from Meat
and Poultry Products'' is available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an
[[Page 38866]]
establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product and take appropriate
corrective actions.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard
on the third consecutive series of FSIS-conducted tests for that
product, constitutes failure to maintain sanitary conditions and
failure to maintain an adequate HACCP plan, in accordance with part 417
of this chapter, for that product, and will cause FSIS to suspend
inspection services. Such suspension will remain in effect until the
establishment submits to the FSIS Administrator or his/her designee
satisfactory written assurances detailing the action taken to correct
the HACCP system and, as appropriate, other measures taken by the
establishment to reduce the prevalence of pathogens.
7. The authority citation for part 320 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
8. Section 320.6 is amended by revising paragraph (a) to read as
follows:
Sec. 320.6 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection, as may be required by the
Administrator in special cases.
* * * * *
PART 327--IMPORTED PRODUCTS
9. The authority citation for Part 327 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
10. Section 327.2 is amended by redesignating paragraphs (a)(2)(i)
(a)-(g) as (a)(2)(i) (A)-(G), redesignating paragraphs (a)(2)(ii) (a)-
(g) to (a)(2)(ii) (A)-(G), redesignating paragraph (a)(2)(ii)(h) as
(a)(2)(ii)(I), and by adding a new paragraph (a)(2)(ii)(H) to read as
set forth below, and by redesignating paragraphs (a)(2)(iv) (a)-(c) as
(a)(2)(iv) (A)-(C).
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
11. The authority citation for part 381 is revised to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
Subpart D--Application for Inspection; Grant or Refusal of
Inspection
12. A new Sec. 381.22 is added to subpart D to read as follows:
Sec. 381.22 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, in
accordance with Part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, in accordance with Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
Subpart H--Sanitation
13. Section 381.45 is amended to read as follows:
Sec. 381.45 Minimum standards for sanitation, facilities, and
operating procedures in official establishments.
The provisions of Secs. 381.46 and 381.61, inclusive, and part 416
of this chapter shall apply with respect to all official
establishments.
Subpart K--Post Mortem Inspection: Disposition of Carcasses and
Parts
14. Section 381.94 is added to subpart K to read as follows:
Sec. 381.94 Contamination with Microorganisms; process control
verification criteria and testing; pathogen reduction standards.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters poultry shall test
for Escherichia coli Biotype I (E. coli) and shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees
designated to collect samples, and shall address location(s) of
sampling, how sampling randomness is achieved, and handling of the
sample to ensure sample integrity. The written procedure shall be made
available to FSIS upon request.
(ii) Sample collection. The establishment shall collect random
samples from carcasses. Carcasses to be sampled will be selected
randomly. Samples shall be collected by taking a whole bird from the
end of the chilling process, after the drip line, and rinsing it in an
amount of buffer appropriate for the type of bird being tested. 1
---------------------------------------------------------------------------
\1\ A copy of FSIS's guideline, ``Sampling Technique for E. coli
in Raw Meat and Poultry for Process Control Verification,'' is
available in the FSIS Docket Room for inspection.
---------------------------------------------------------------------------
(iii) Sampling frequency. Samples will be taken at a frequency
proportional to a slaughter establishment's volume of production, at
the following rates:
Chickens: 1 sample per 22,000 carcasses
Turkeys: 1 sample per 3,000 carcasses
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that
[[Page 38867]]
the alternative frequency is inadequate to verify the effectiveness of
the establishment's processing controls.
(v) Sampling in very low volume establishments.
(A) An establishment annually slaughtering no more than 440,000
chickens, 60,000 turkeys, or a combination of chickens and turkeys not
exceeding 60,000 turkeys and 440,000 birds total, shall collect one
sample per week starting the first full week of June through August of
each year. An establishment slaughtering both chickens and turkeys
shall collect samples from the species it slaughters in larger numbers.
Weekly samples shall be collected and tested until the establishment
has completed and recorded one series of 13 tests that meets the
criteria shown in Table 1 of paragraph (a)(5) of this section.
(B) Upon the establishment's meeting the requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or by
FSIS. FSIS determinations that changes have been made requiring
resumption of weekly testing shall be provided to the establishment in
writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for analysis of E. coli that is sensitive to 5 or fewer cfu/ml
of rinse fluid and is approved by the Association of Official Analytic
Chemists International 2 or approved by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95 percent upper and lower confidence
limit of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the ``Official Methods of Analysis of the
Association of Official Analytical Chemists International,'' 16th
edition, 1995, is on file with the Director, Office of the Federal
Register, and may be purchased from the Association of Official
Analytical Chemists International, Inc., 481 North Frederick Ave.,
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of cfu/ml of rinse
fluid. Results shall be recorded onto a process control chart or table
showing at least the most recent 13 test results, by kind of poultry
slaughtered, permitting evaluation of the laboratory results in
accordance with the criteria set forth in paragraph (a)(5) of this
section. Records shall be retained at the establishment for a period of
12 months and shall be made available to FSIS upon request.
(5) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels above (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. coli Test Results
----------------------------------------------------------------------------------------------------------------
Maximum number
Lower limit of Upper limit of Number of sample permitted in
Slaughter class marginal range marginal range tested (n) marginal range
(m) (M) (c)
----------------------------------------------------------------------------------------------------------------
Broilers............................ 100 cfu/ml 1,000 cfu/ml 13 3
Turkeys............................. a N.A. N.A. N.A. N.A.
----------------------------------------------------------------------------------------------------------------
a Not available; values for turkeys will be added upon completion of data collection program for turkeys.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection will be suspended in
accordance with rules of practice that will be adopted for such
proceeding, upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standards; Salmonella.
(1) Raw poultry product performance standards for Salmonella. (i)
An establishment's raw poultry products, when sampled and tested by
FSIS for Salmonella as set forth in this section, may not test positive
for Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance Maximum number of
Standard (percent Number of samples positives to
Class of product positive for tested (n) achieve Standard
Salmonella) a (c)
----------------------------------------------------------------------------------------------------------------
Broilers............................................... b 20.0% 51 12
Ground chicken......................................... 44.6 53 26
Ground turkey.......................................... 49.9 53 29
Turkeys................................................ b N.A. N.A. N.A.
----------------------------------------------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw
products based on data developed by FSIS in its nationwide microbiological baseline data collection programs
and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of Salmonella on raw products are avialable in the
FSIS Docket Room.)
b Standard is based on partial analysis of baseline survey data; subject to confirmation upon publication of
baseline survey report.
d Not available; baseline targets for turkeys will be added upon completion of the data collection programs for
that product.
[[Page 38868]]
(2) Enforcement. FSIS will sample and test raw poultry products in
an individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.3
---------------------------------------------------------------------------
\3\ A copy of FSIS's ``Sample Collection Guidelines and
Procedure for Isolation and Identification of Salmonella from Raw
Meat and Poultry Products'' is available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard
on the third consecutive series of FSIS-conducted tests for that
product, constitutes failure to maintain sanitary conditions and
failure to maintain an adequate HACCP plan, in accordance with part 417
of this chapter, for that product, and will cause FSIS to suspend
inspection services. Such suspension will remain in effect until the
establishment submits to the FSIS Administrator or his/her designee
satisfactory written assurances detailing the action taken to correct
the HACCP system and, as appropriate, other measures taken by the
establishment to reduce the prevalence of pathogens.
Subpart Q--Records, Registration, and Reports
15. Section 381.180 is amended by revising paragraph (a) to read as
follows:
Sec. 381.180 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection thereat, as may be required
by the Administrator in special cases.
* * * * *
Subpart T--Imported Poultry Products
16. Section 381.196 is amended by redesignating paragraphs
(a)(2)(i) (a)-(g) as paragraphs (a)(2)(i) (A)-(G), redesignating
paragraphs (a)(2)(ii) (a)-(g) to (a)(2)(ii) (A)-(G), redesignating
paragraph (a)(2)(ii)(h) as (a)(2)(ii)(I), and by adding a new paragraph
(a)(2)(ii)(H) to read as set forth below, and redesignating paragraphs
(a)(2)(iv) (a)-(c) as (a)(2)(iv)(A)-(c).
Sec. 381.196 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
* * * * *
17. A new subchapter E, consisting of Parts 416 and 417 is added to
chapter III--Food Safety and Inspection Service, Meat and Poultry
Inspection, Department of Agriculture to read as follows:
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION
ACT AND THE POULTRY PRODUCTS INSPECTION ACT
Part
416 Sanitation
417 Hazard Analysis and Critical Control Point (HACCP) Systems
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT
INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT
PART 416--SANITATION
Sec.
416.11 General rules.
416.12 Development of sanitation SOP's.
416.13 Implementation of SOP's.
416.14 Maintenance of Sanitation SOP's.
416.15 Corrective Actions.
416.16 Recordkeeping Requirements.
416.17 Agency verification.
Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906;
7 CFR 2.18, 2.53.
Sec. 416.11 General rules.
Each official establishment shall develop, implement, and maintain
written standard operating procedures for sanitation (Sanitation SOP's)
in accordance with the requirements of this part.
Sec. 416.12 Development of Sanitation SOP's.
(a) The Sanitation SOP's shall describe all procedures an official
establishment will conduct daily, before and during operations,
sufficient to prevent direct contamination or adulteration of
product(s).
(b) The Sanitation SOP's shall be signed and dated by the
individual with overall authority on-site or a higher level official of
the establishment. This signature shall signify that the establishment
will implement the Sanitation SOP's as specified and will maintain the
Sanitation SOP's in accordance with the requirements of this part. The
Sanitation SOP's shall be signed and dated upon initially implementing
the Sanitation SOP's and upon any modification to the Sanitation SOP's.
(c) Procedures in the Sanitation SOP's that are to be conducted
prior to operations shall be identified as such, and shall address, at
a minimum, the cleaning of food contact surfaces of facilities,
equipment, and utensils.
(d) The Sanitation SOP's shall specify the frequency with which
each procedure in the Sanitation SOP's is to be conducted and identify
the establishment employee(s) responsible for the implementation and
maintenance of such procedure(s).
Sec. 416.13 Implementation of SOP's.
(a) Each official establishment shall conduct the pre-operational
procedures in the Sanitation SOP's before the start of operations.
(b) Each official establishment shall conduct all other procedures
in the Sanitation SOP's at the frequencies specified.
(c) Each official establishment shall monitor daily the
implementation of the procedures in the Sanitation SOP's.
Sec. 416.14 Maintenance of Sanitation SOP's.
Each official establishment shall routinely evaluate the
effectiveness of the Sanitation SOP's and the procedures therein in
preventing direct contamination or adulteration of product(s) and shall
revise both as necessary to keep them effective and current with
respect to changes in facilities, equipment, utensils, operations, or
personnel.
Sec. 416.15 Corrective Actions.
(a) Each official establishment shall take appropriate corrective
action(s) when either the establishment or FSIS determines that the
establishment's Sanitation SOP's or the procedures specified therein,
or the implementation or maintenance of the Sanitation SOP's, may have
failed to prevent direct
[[Page 38869]]
contamination or adulteration of product(s).
(b) Corrective actions include procedures to ensure appropriate
disposition of product(s) that may be contaminated, restore sanitary
conditions, and prevent the recurrence of direct contamination or
adulteration of product(s), including appropriate reevaluation and
modification of the Sanitation SOP's and the procedures specified
therein.
Sec. 416.16 Recordkeeping requirements.
(a) Each official establishment shall maintain daily records
sufficient to document the implementation and monitoring of the
Sanitation SOP's and any corrective actions taken. The establishment
employee(s) specified in the Sanitation SOP's as being responsible for
the implementation and monitoring of the procedure(s) specified in the
Sanitation SOP's shall authenticate these records with his or her
initials and the date.
(b) Records required by this part may be maintained on computers
provided the establishment implements appropriate controls to ensure
the integrity of the electronic data.
(c) Records required by this part shall be maintained for at least
6 months and made accesable available to FSIS. All such records shall
be maintained at the official establishment for 48 hours following
completion, after which they may be maintained off-site provided such
records can be made available to FSIS within 24 hours of request.
Sec. 416.17 Agency verification.
FSIS shall verify the adequacy and effectiveness of the Sanitation
SOP's and the procedures specified therein by determining that they
meet the requirements of this part. Such verification may include:
(a) Reviewing the Sanitation SOP's;
(b) Reviewing the daily records documenting the implementation of
the Sanitation SOP's and the procedures specified therein and any
corrective actions taken or required to be taken;
(c) Direct observation of the implementation of the Sanitation
SOP's and the procedures specified therein and any corrective actions
taken or required to be taken; and
(d) Direct observation or testing to assess the sanitary conditions
in the establishment.
PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
Sec.
417.1 Definitions.
417.2 Hazard analysis and HACCP plan.
417.3 Corrective actions.
417.4 Validation, verification, reassessment.
417.5 Records.
417.6 Inadequate HACCP Systems.
417.7 Training.
417.8 Agency verification.
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C.
1901-1906; 7 CFR 2.18, 2.53.
Sec. 417.1 Definitions.
For purposes of this part, the following definitions shall apply:
Corrective action. Procedures to be followed when a deviation
occurs.
Critical control point. A point, step, or procedure in a food
process at which control can be applied and, as a result, a food safety
hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit. The maximum or minimum value to which a physical,
biological, or chemical hazard must be controlled at a critical control
point to prevent, eliminate, or reduce to an acceptable level the
occurrence of the identified food safety hazard.
Food safety hazard. Any biological, chemical, or physical property
that may cause a food to be unsafe for human consumption.
HACCP System. The HACCP plan in operation, including the HACCP
plan itself.
Hazard. SEE Food Safety Hazard.
Preventive measure. Physical, chemical, or other means that can be
used to control an identified food safety hazard.
Process-monitoring instrument. An instrument or device used to
indicate conditions during processing at a critical control point.
Responsible establishment official. The individual with overall
authority on-site or a higher level official of the establishment.
Sec. 417.2 Hazard Analysis and HACCP Plan.
(a) Hazard analysis. (1) Every official establishment shall
conduct, or have conducted for it, a hazard analysis to determine the
food safety hazards reasonably likely to occur in the production
process and identify the preventive measures the establishment can
apply to control those hazards. The hazard analysis shall include food
safety hazards that can occur before, during, and after entry into the
establishment. A food safety hazard that is reasonably likely to occur
is one for which a prudent establishment would establish controls
because it historically has occurred, or because there is a reasonable
possibility that it will occur in the particular type of product being
processed, in the absence of those controls.
(2) A flow chart describing the steps of each process and product
flow in the establishment shall be prepared, and the intended use or
consumers of the finished product shall be identified.
(3) Food safety hazards might be expected to arise from the
following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Zoonotic diseases;
(vii) Decomposition;
(viii) Parasites;
(ix) Unapproved use of direct or indirect food or color additives;
and
(x) Physical hazards.
(b) The HACCP plan. (1) Every establishment shall develop and
implement a written HACCP plan covering each product produced by that
establishment whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, based on the hazard
analysis conducted in accordance with paragraph (a) of this section,
including products in the following processing categories:
(i) Slaughter--all species.
(ii) Raw product--ground.
(iii) Raw product--not ground.
(iv) Thermally processed--commercially sterile.
(v) Not heat treated--shelf stable.
(vi) Heat treated--shelf stable.
(vii) Fully cooked--not shelf stable.
(viii) Heat treated but not fully cooked--not shelf stable.
(ix) Product with secondary inhibitors--not shelf stable.
(2) A single HACCP plan may encompass multiple products within a
single processing category identified in this paragraph, if the food
safety hazards, critical control points, critical limits, and
procedures required to be identified and performed in paragraph (c) of
this section are essentially the same, provided that any required
features of the plan that are unique to a specific product are clearly
delineated in the plan and are observed in practice.
(3) HACCP plans for thermally processed/commercially sterile
products do not have to address the food safety hazards associated with
microbiological contamination if the product is produced in accordance
with the requirements of part 318, subpart G, or part 381, subpart X,
of this chapter.
(c) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List the food safety hazards identified in accordance with
paragraph (a) of this section, which must be controlled for each
process.
[[Page 38870]]
(2) List the critical control points for each of the identified
food safety hazards, including, as appropriate:
(i) Critical control points designed to control food safety hazards
that could be introduced in the establishment, and
(ii) Critical control points designed to control food safety
hazards introduced outside the establishment, including food safety
hazards that occur before, during, and after entry into the
establishment;
(3) List the critical limits that must be met at each of the
critical control points. Critical limits shall, at a minimum, be
designed to ensure that applicable targets or performance standards
established by FSIS, and any other requirement set forth in this
chapter pertaining to the specific process or product, are met;
(4) List the procedures, and the frequency with which those
procedures will be performed, that will be used to monitor each of the
critical control points to ensure compliance with the critical limits;
(5) Include all corrective actions that have been developed in
accordance with Sec. 417.3(a) of this part, to be followed in response
to any deviation from a critical limit at a critical control point; and
(6) Provide for a recordkeeping system that documents the
monitoring of the critical control points. The records shall contain
the actual values and observations obtained during monitoring.
(7) List the verification procedures, and the frequency with which
those procedures will be performed, that the establishment will use in
accordance with Sec. 417.4 of this part.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be
signed and dated by the responsible establishment individual. This
signature shall signify that the establishment accepts and will
implement the HACCP plan.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) At least annually, upon reassessment, as required under
Sec. 417.4(a)(3) of this part.
(e) Pursuant to 21 U.S.C. 608 and 621, the failure of an
establishment to develop and implement a HACCP plan that complies with
this section, or to operate in accordance with the requirements of this
part, may render the products produced under those conditions
adulterated.
Sec. 417.3 Corrective actions.
(a) The written HACCP plan shall identify the corrective action to
be followed in response to a deviation from a critical limit. The HACCP
plan shall describe the corrective action to be taken, and assign
responsibility for taking corrective action, to ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is
taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated
as a result of the deviation enters commerce.
(b) If a deviation not covered by a specified corrective action
occurs, or if another unforeseen hazard arises, the establishment
shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform a review to determine the acceptability of the affected
product for distribution;
(3) Take action, when necessary, with respect to the affected
product to ensure that no product that is injurious to health or
otherwise adulterated, as a result of the deviation, enters commerce;
(4) Perform or obtain reassessment by an individual trained in
accordance with Sec. 417.7 of this part, to determine whether the newly
identified deviation or other unforeseen hazard should be incorporated
into the HACCP plan.
(c) All corrective actions taken in accordance with this section
shall be documented in records that are subject to verification in
accordance with Sec. 417.4(a)(2)(iii) and the recordkeeping
requirements of Sec. 417.5 of this part.
Sec. 417.4 Validation, Verification, Reassessment.
(a) Every establishment shall validate the HACCP plan's adequacy in
controlling the food safety hazards identified during the hazard
analysis, and shall verify that the plan is being effectively
implemented.
(1) Initial validation. Upon completion of the hazard analysis and
development of the HACCP plan, the establishment shall conduct
activities designed to determine that the HACCP plan is functioning as
intended. During this HACCP plan validation period, the establishment
shall repeatedly test the adequacy of the CCP's, critical limits,
monitoring and recordkeeping procedures, and corrective actions set
forth in the HACCP plan. Validation also encompasses reviews of the
records themselves, routinely generated by the HACCP system, in the
context of other validation activities.
(2) Ongoing verification activities. Ongoing verification
activities include, but are not limited to:
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective
actions; and
(iii) The review of records generated and maintained in accordance
with Sec. 417.5(a)(3) of this part.
(3) Reassessment of the HACCP plan. Every establishment shall
reassess the adequacy of the HACCP plan at least annually and whenever
any changes occur that could affect the hazard analysis or alter the
HACCP plan. Such changes may include, but are not limited to, changes
in: raw materials or source of raw materials; product formulation;
slaughter or processing methods or systems; production volume;
personnel; packaging; finished product distribution systems; or, the
intended use or consumers of the finished product. The reassessment
shall be performed by an individual trained in accordance with
Sec. 417.7 of this part. The HACCP plan shall be modified immediately
whenever a reassessment reveals that the plan no longer meets the
requirements of Sec. 417.2(c) of this part.
(b) Reassessment of the hazard analysis. Any establishment that
does not have a HACCP plan because a hazard analysis has revealed no
food safety hazards that are reasonably likely to occur shall reassess
the adequacy of the hazard analysis whenever a change occurs that could
reasonably affect whether a food safety hazard exists. Such changes may
include, but are not limited to, changes in: raw materials or source of
raw materials; product formulation; slaughter or processing methods or
systems; production volume; packaging; finished product distribution
systems; or, the intended use or consumers of the finished product.
Sec. 417.5 Records.
(a) The establishment shall maintain the following records
documenting the establishment's HACCP plan:
(1) The written hazard analysis prescribed in Sec. 417.2(a) of this
part, including all supporting documentation;
(2) The written HACCP plan, including decisionmaking documents
associated with the selection and development of CCP's and critical
limits, and documents supporting both the monitoring and verification
procedures selected and the frequency of those procedures.
(3) Records documenting the monitoring of CCP's and their critical
limits, including the recording of actual
[[Page 38871]]
times, temperatures, or other quantifiable values, as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring
instruments; corrective actions, including all actions taken in
response to a deviation; verification procedures and results; product
code(s), product name or identity, or slaughter production lot. Each of
these records shall include the date the record was made.
(b) Each entry on a record maintained under the HACCP plan shall be
made at the time the specific event occurs and include the date and
time recorded, and shall be signed or initialed by the establishment
employee making the entry.
(c) Prior to shipping product, the establishment shall review the
records associated with the production of that product, documented in
accordance with this section, to ensure completeness, including the
determination that all critical limits were met and, if appropriate,
corrective actions were taken, including the proper disposition of
product. Where practicable, this review shall be conducted, dated, and
signed by an individual who did not produce the record(s), preferably
by someone trained in accordance with Sec. 417.7 of this part, or the
responsible establishment official.
(d) Records maintained on computers. The use of records maintained
on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures.
(e) Record retention. (1) Establishments shall retain all records
required by paragraph (a)(3) of this section as follows: for slaughter
activities for at least one year; for refrigerated product, for at
least one year; for frozen, preserved, or shelf-stable products, for at
least two years.
(2) Off-site storage of records required by paragraph (a)(3) of
this section is permitted after six months, if such records can be
retrieved and provided, on-site, within 24 hours of an FSIS employee's
request.
(f) Official review. All records required by this part and all
plans and procedures required by this part shall be available for
official review and copying.
Sec. 417.6 Inadequate HACCP Systems.
A HACCP system may be found to be inadequate if:
(a) The HACCP plan in operation does not meet the requirements set
forth in this part;
(b) Establishment personnel are not performing tasks specified in
the HACCP plan;
(c) The establishment fails to take corrective actions, as required
by Sec. 417.3 of this part;
(d) HACCP records are not being maintained as required in
Sec. 417.5 of this part; or
(e) Adulterated product is produced or shipped.
Sec. 417.7 Training.
(a) Only an individual who has met the requirements of paragraph
(b) of this section, but who need not be an employee of the
establishment, shall be permitted to perform the following functions:
(1) Development of the HACCP plan, in accordance with Sec. 417.2(b)
of this part, which could include adapting a generic model that is
appropriate for the specific product; and
(2) Reassessment and modification of the HACCP plan, in accordance
with Sec. 417.3 of this part.
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed a course of
instruction in the application of the seven HACCP principles to meat or
poultry product processing, including a segment on the development of a
HACCP plan for a specific product and on record review.
Sec. 417.8 Agency verification.
FSIS will verify the adequacy of the HACCP plan(s) by determining
that each HACCP plan meets the requirements of this part and all other
applicable regulations. Such verification may include:
(a) Reviewing the HACCP plan;
(b) Reviewing the CCP records;
(c) Reviewing and determining the adequacy of corrective actions
taken when a deviation occurs;
(d) Reviewing the critical limits;
(e) Reviewing other records pertaining to the HACCP plan or system;
(f) Direct observation or measurement at a CCP;
(g) Sample collection and analysis to determine the product meets
all safety standards; and
(h) On-site observations and record review.
Done at Washington, DC, on: July 5, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
The following are appendices to the preamble of the Final Rule.
Note: The following appendices will not appear in the Code of
Federal Regulations.
Appendix A--Guidelines for Developing a Standard Operating Procedure
for Sanitation (Sanitation SOP's) in Federally Inspected Meat and
Poultry Establishments
I. Introduction
Foodborne illness is a significant public health problem in the
United States. While data on illness associated with meat and poultry
products are limited, data from various sources suggest that foodborne
microbial pathogens may cause up to 7 million cases of illness each
year, and 7,000 deaths. Of these, nearly 5 million cases of illness and
more than 4,000 deaths may be associated with meat and poultry
products.
FSIS is pursuing a broad and long-term science-based strategy to
improve the safety of meat and poultry products to better protect
public health. FSIS is undertaking steps to improve the safety of meat
and poultry throughout the food production, processing, distribution,
and marketing chain. The Agency's goal is to reduce the risk to public
health of consuming meat and poultry products by reducing pathogenic
microbial contamination. The FSIS strategy relies heavily on building
the principle of prevention into production processes.
Sections 308.7, 381.57 and 381.58 of the Meat and Poultry
Inspection Regulations require that rooms, compartments, equipment, and
utensils used for processing or handling meat or poultry in a federally
inspected establishment must be kept clean and in a sanitary condition.
Establishments are responsible for sanitation of facilities, equipment
and utensils.
Sanitation maintains or restores a state of cleanliness, and
promotes hygiene for the prevention of foodborne illness. Sanitation
encompasses many areas and functions of an establishment, even when not
in production. However, there are certain sanitary procedures that must
be addressed and maintained on a daily basis to prevent direct product
contamination or adulteration. Good sanitation is essential in these
areas to maintaining a safe food production process.
FSIS is requiring meat and poultry establishments to develop and
implement a written Standard Operating Procedure for sanitation
(Sanitation SOP's) which addresses these areas. An establishment's
adherence to its written Sanitation SOP will demonstrate knowledge of
and commitment to sanitation and production of safe meat and poultry
products.
New part 416 to the Meat and Poultry Inspection Regulations
requires that a written Sanitation SOP contain
[[Page 38872]]
established procedures to be followed routinely to maintain a sanitary
environment for producing safe and unadulterated food products. Plant
management must develop a Sanitation SOP that describes daily
sanitation procedures to be performed by the establishment. A
designated establishment employee(s) must monitor the Sanitation SOP
and document adherence to the SOP and any corrective actions taken to
prevent direct product contamination or adulteration. This written
documentation must be available to FSIS program employees.
These FSIS guidelines should help federally inspected meat or
poultry establishments develop, implement and monitor written
Sanitation SOPs.
The Sanitation SOP developed by the establishment must detail daily
sanitation procedures it will use before (pre-operational sanitation)
and during (operational sanitation) operation to prevent direct product
contamination or adulteration. FSIS program employees will verify an
establishment's adherence to its Sanitation SOP and will take
appropriate action when there is noncompliance.
These guidelines, where applicable, are for:
Livestock Slaughter and/or Processing Establishments
Poultry Slaughter and/or Processing Establishments
Import Inspection Establishments
Identification Warehouses
The establishment should update the Sanitation SOP to reflect
changes in equipment and facilities, processes, new technology, or
designated establishment employees.
II. Pre-operational Sanitation
Established procedures of pre-operational sanitation must result in
clean facilities, equipment and utensils prior to starting production.
Clean facilities, equipment, and utensils are free of any soil, tissue
debris, chemical or other injurious substance that could contaminate a
meat or poultry food product. Pre-operational sanitation established
procedures shall describe the daily, routine sanitary procedures to
prevent direct product contamination or adulteration. The sanitary
procedures must include the cleaning of product contact surfaces of
facilities, equipment and utensils to prevent direct product
contamination or adulteration. The following additional sanitary
procedures for pre-operational sanitation might include:
Descriptions of equipment disassembly, reassembly after
cleaning, use of acceptable chemicals according to label directions,
and cleaning techniques.
The application of sanitizers to product contact surfaces
after cleaning. Sanitizers are used to reduce or destroy bacteria that
may have survived the cleaning process.
III. Operational Sanitation
All federally inspected establishments must describe daily, routine
sanitary procedures that the establishment will conduct during
operations to prevent direct product contamination or adulteration.
Established procedures for operational sanitation must result in a
sanitary environment for preparing, storing, or handling any meat or
poultry food product in accordance with sections 308/381 of the Meat
and Poultry Inspection Regulations. Established procedures during
operations might include, where applicable:
Equipment and utensil cleaning--sanitizing--disinfecting
during production, as appropriate, at breaks, between shifts, and at
midshift cleanup.
Employee hygiene: includes personal hygiene, cleanliness
of outer garments and gloves, hair restraints, hand washing, health,
etc.
Product handling in raw and in cooked product areas.
The established sanitary procedures for operational sanitation will
vary with the establishment. Establishments with complex processing
need additional sanitary procedures to ensure a sanitary environment
and to prevent cross contamination. Establishments that do not
slaughter or process (such as an Import Inspection facility) should
develop established sanitary procedures specific to that facility.
IV. Implementing and Monitoring of the Sanitation SOP
The Sanitation SOP shall identify establishment employee(s)
(positions rather than specific names of employees) responsible for the
implementation and maintenance of the Sanitation SOP. Employee(s) are
to be identified to monitor and evaluate the effectiveness of the
Sanitation SOP and make corrections when needed. The evaluation can be
performed by using one or more of the following methods: (1)
organoleptic (sensory--e.g., sight, feel, smell); (2) chemical (e.g.,
checking the chlorine level); (3) microbiological (e.g., microbial
swabbing and culturing of product contact surfaces of equipment or
utensils).
Establishments might specify the method, frequency, and
recordkeeping processes associated with monitoring. Pre-operational
sanitation monitoring should, at a minimum, evaluate and document the
effective cleaning of all direct product contact facilities, equipment,
and/or utensils that are to be used at the start of production.
Operational sanitation monitoring should, at a minimum, document
adherence to the SOP, including actions that identify and correct
instances or circumstances of direct product contamination which occur
from environmental sources (facilities, equipment, pests, etc.) or
employee practices (personal hygiene, product handling, etc.). All
establishment records of pre-operational and operational sanitation
monitoring, including corrective actions to prevent direct product
contamination or adulteration, must be maintained by the establishment
for at least six months, and be made available to FSIS program
employees. After 48 hours, they may be maintained off-site.
V. Corrective Actions
When deviations occur from the established sanitary procedures
within the Sanitation SOP, the establishment must take corrective
actions to prevent direct product contamination or adulteration.
Instructions should be provided to employees and management officials
for documenting corrective actions. The actions must be recorded.
Appendix B--Model of a Standard Operating Procedure for Sanitation
Hill-Top Meats has prepared a written Standard Operating Procedure
(SOP) for Sanitation. Let's look at the Sanitation SOP and discuss its
attributes (guidance and advice are inside the boxes).
Hill-Top Meats, Est. 38, Anytown, U.S.A. is a slaughter and medium
processing establishment. This plant receives live cattle for slaughter
and dressing and processes the carcasses into chubs of ground beef,
roast beef, and ready to eat beef products.
------------------------------------------------------------------------
-------------------------------------------------------------------------
This introductory information is not a regulatory requirement but
identifies the type of establishment and its production. The
information will help FSIS personnel, who are not familiar with the
establishment, review the Sanitation SOP.
------------------------------------------------------------------------
Management structure is as follows:
President--Joe Doe
Slaughter Manager--Ken Smith
Processing Manager--Susan Jones
Quality Control (QC) Manager--Gwen Summers
Sanitation Manager--Carl Anderson
The QC Manager is responsible for implementing and daily monitoring
of the Sanitation SOP and recording the findings and any corrective
actions. The
[[Page 38873]]
Slaughter, Processing and Sanitation Managers are responsible for
training and assigning specific duties to other employees and
monitoring their performance within the Sanitation SOP.
All records, data, checklists and other information pertaining to
the Sanitation SOP will be maintained on file and made available to
FSIS program employees.
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-------------------------------------------------------------------------
The identification of establishment personnel (positions rather than
specific names of employees) responsible for implementing, maintaining,
monitoring and records associated with the Sanitation SOP is a
regulatory requirement. All records pertaining to the Sanitation SOP
must be kept on file and made available to FSIS personnel, but it is
not necessary to make that statement.
------------------------------------------------------------------------
Sanitation SOP for EST. 38
I. Preoperational Sanitation--Equipment and Facility Cleaning Objective
All equipment will be cleaned and sanitized prior to starting
production.
A. General Equipment Cleaning. (Simple equipment and hand tools are
cleaned and sanitized in the same manner but they do not require
disassembly and reassembly.)
1. Established Sanitary Procedures for Cleaning and Sanitizing
Equipment:
a. The equipment is disassembled. Parts are placed in the
designated tubs, racks, etc.
b. Product debris is removed.
c. Equipment parts are rinsed with water to remove remaining
debris.
d. An approved cleaner is applied to parts and they are cleaned
according to manufacturers' directions.
e. Equipment parts are rinsed with potable water.
f. Equipment is sanitized with an approved sanitizer, and rinsed
with potable water if required.
g. The equipment is reassembled.
h. The equipment is resanitized with an approved sanitizer, and
rinsed with potable water if required.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The established sanitary procedures are daily routine sanitary
procedures to prevent direct product contamination or adulteration.
Daily routine sanitary procedures to prevent direct product
contamination or adulteration are required in the Sanitation SOP; FSIS
personnel use them to verify compliance with the Sanitation SOP. The
procedures shall be specific for each establishment; however, they can
be as detailed as the establishment wants to make them.
------------------------------------------------------------------------
2. Implementing, Monitoring and Recordkeeping. The QC Manager
performs daily organoleptic sanitation inspection after preoperational
equipment cleaning and sanitizing. The results of the inspection are
recorded on Establishment Form E-1. If everything is acceptable, the
appropriate box is initialed. If corrective actions are needed, such
actions are to be documented (see below).
The QC Manager performs daily microbial monitoring for Total Plate
Counts (TPCs) after preoperational equipment cleaning and sanitizing.
The QC Manager swabs one square inch of a food contact surface on a
piece of equipment or hand tool within one hour prior to production.
The samples are plated and incubated at 35 deg. C. for 48 hours.
Colonies are counted and recorded as number of colony forming units
(CFU) per square inch of surface swabbed. Daily microbial counts are
documented on Establishment Form M-1.
3. Corrective Actions.
a. When the QC Manager determines that the equipment or hand tools
do not pass organoleptic examination, the cleaning procedure and
reinspection are repeated. The Sanitation Manager monitors the cleaning
of the equipment or hand tools and retrains sanitation crew employees,
if necessary. Corrective actions are recorded on Establishment Form E-
1.
b. If microbial counts exceed ____ CFUs/sq. in., the QC Manager
notifies the Sanitation Manager and attempts to determine the cause of
the high count (for example, cleaning procedures varied, new people
cleaned the equipment, sanitizer not applied). If microbial counts
remain high for several days, the QC Manager will confer with the
Sanitation Manager. The Sanitation Manager notifies sanitation crew
employees and reviews all cleaning and sanitizing procedures and
personal hygiene. Microbial counts are recorded on Establishment Form
M-1. Corrective actions to prevent direct product contamination or
adulteration are documented on Establishment Form E-1.
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-------------------------------------------------------------------------
The establishment is required to monitor daily routine sanitation
activities as described in the Sanitation SOP, the establishment
determines the methods and frequency of monitoring. Microbiological
sampling is not required, but Hill-Top Meats wants to monitor the
effectiveness of the cleaning by daily microbial sampling, in addition
to organoleptic monitoring, and has set limits to enable them to take
appropriate action when those limits are exceeded. Establishment Forms
E-1 and M-1 are used only as examples; no specific forms or form
numbers are required. However, establishments must record the daily
completion or adherence to the established procedures in the Sanitation
SOP, any deviations from regulatory requirements, and corrective
actions.
------------------------------------------------------------------------
B. Cleaning of Facilities--including floors, walls and ceilings.
1. Cleaning Procedures.
a. Debris is swept up and discarded.
b. Facilities are rinsed with potable water.
c. Facilities are cleaned with an approved cleaner, according to
manufacturer's directions.
d. Facilities are rinsed with potable water.
2. Cleaning Frequency.
Floors and walls are cleaned at the end of each production day.
Ceilings are cleaned as needed, but at least once a week.
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There is no specific requirement to include facility cleaning in the
Sanitation SOP, unless part of the facility could directly contaminate
or adulterate product.
------------------------------------------------------------------------
3. Establishment Monitoring.
The QC Manager performs daily organoleptic inspection prior to the
start of operations. Results are recorded on Establishment Form E-1.
4. Corrective Actions.
When the QC Manager determines that the facilities do not pass
organoleptic inspection, the cleaning procedure and reinspection are
repeated. The Sanitation Manager monitors the cleaning of facilities
and retrains sanitation crew employees if necessary. Corrective actions
to prevent direct product contamination or adulteration are recorded on
Establishment Form E-1.
II. Operational Sanitation
Objective: Carcass dressing will be performed under sanitary
conditions and in a manner to prevent contamination of the carcass.
A. Slaughter Operations.
1. Established Methods for Carcass Dressing--
a. Employees will clean hands, arms, gloves, aprons, boots, etc.,
as often as
[[Page 38874]]
necessary during the dressing procedures.
b. Employees will clean and then sanitize with 180 deg. F. water,
knives and other hand tools, saws and other equipment, as often as
necessary during the dressing procedures to prevent contamination of
the skinned carcass.
c. The brisket saw is sanitized between carcasses using 180 deg. F.
water.
d. Eviscerating employees will maintain clean hands, arms, clothes,
aprons, boots and knives during the evisceration process. If
contamination occurs, the employee is required to step away from the
evisceration table onto a side platform to clean and sanitize apron,
boots and knives. It may be necessary to clean hands and arms with soap
and water. In cases of contamination from an abscess or other extensive
contamination, the employee may need to shower and change clothes
before resuming work.
e. The carcass splitting saw is sanitized with 180 deg. F. water
after each carcass.
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The above methods for carcass dressing are specific for Hill-Top Meats.
The establishment considers them to be Good Manufacturing Practices for
their type of operation, to prevent direct contamination or
adulteration of carcasses. Each establishment determines the sanitary
procedures and any requirements they want to detail in their Sanitation
SOP.
------------------------------------------------------------------------
2. Monitoring and Recordkeeping.
a. The Slaughter Manager is responsible for ensuring that employee
hygiene practices, sanitary conditions and cleaning procedures are
maintained during a production shift. The QC Manager monitors the
sanitation procedures twice during a production shift. Results are
recorded on Establishment Form E-1.
b. A Microbiological Control and Monitoring Program is used to
determine the level of bacteria on product contact surfaces of
equipment (e.g., knives, hand tools, evisceration table, etc.) and
outer garments (such as aprons and gloves) during production. The QC
Manager performs daily microbial monitoring for Total Plate Counts
(TPCs). The samples are plated and incubated at 35 deg.C. for 48 hours.
Colonies are counted and recorded as number of colony forming units
(CFU) per square inch of surface swabbed. Daily microbial counts are
documented on Establishment Form M-1.
3. Corrective Actions.
a. When equipment is visibly contaminated, contaminants are removed
by cleaning and sanitizing equipment prior to resuming production. The
Slaughter Manager attempts to determine the cause of the contamination
and takes corrective action. This may require adjusting equipment,
retraining employees, temporarily stopping or slowing the line speed,
etc. Corrective actions are recorded on Establishment Form E-1.
b. If microbial counts from equipment swabbing exceed the action
level set, the QC Manager notifies the Slaughter Manager. The Slaughter
Manager attempts to determine the cause (for example, new people not
adequately trained, equipment not adjusted properly) and takes
corrective action. If microbial counts remain above established limits
for several days, the QC Manager confers with the Slaughter Manager and
all slaughter operations are reviewed. The Slaughter Manager notifies
the slaughter employees and reviews personal hygiene, equipment
adjustment, and sanitary handling procedures. Corrective actions to
prevent direct product contamination or adulteration are recorded on
Establishment Form E-1.
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-------------------------------------------------------------------------
The establishment is required to monitor the regulatory daily sanitation
activities as described in its Sanitation SOP, but each establishment
determines its own methods for monitoring, the frequency of monitoring,
and the corrective actions to include in the Sanitation SOP. Records
must be kept on daily completion of the established procedures,
deviations, and corrective actions.
------------------------------------------------------------------------
B. Processing Operations.
Objective: Processing is performed under sanitary conditions to
prevent direct and cross contamination of food products.
1. Established Sanitary Procedures for Processing--
a. Employees clean and sanitize hands, gloves, knives, wizard
knives, other hand tools, cutting boards, etc., as necessary during
processing to prevent contamination of food products.
b. All equipment, belt conveyors, tables, and other product contact
surfaces are cleaned and sanitized throughout the day as needed.
c. Employees take appropriate precautions when going from a raw
product area to a cooked product area, to prevent cross contamination
of cooked products. Employees change outer garments, wash hands and
sanitize hands with an approved hand sanitizer (sanitizer is equivalent
to 50 ppm chlorine), put on clean gloves for that room and step into a
boot sanitizing bath on leaving and entering the respective rooms.
d. Raw and cooked processing areas are separate. There is no cross
utilization of equipment between raw and cooked products.
e. Outer garments, such as aprons, smocks and gloves, are
identified and designated specifically for either the raw processing
rooms or the cooked processing rooms. Blue is designated for raw
processing rooms and orange for cooked processing rooms. The outer
garments are hung in designated locations when an employee leaves each
room. Outer garments are maintained in a clean and sanitary manner and
are changed at least daily and, if necessary, more often.
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-------------------------------------------------------------------------
Establishments with processing will determine their own established
sanitary procedures in the Sanitation SOP and any establishment
requirements. Hill-Top Meats considers its established procedures for
processing to be Good Manufacturing Practices.
------------------------------------------------------------------------
2. Monitoring and Recordkeeping.
a. The Processing Manager is responsible for ensuring that employee
hygiene practices, employee and product traffic patterns, sanitary
product handling procedures, and cleaning procedures are maintained
during a production shift. The QC Manager monitors the sanitation
procedures twice during a production shift. Results are recorded on
Establishment Form P-1.
b. A Microbiological Control and Monitoring Program is used to
determine and control the level of bacteria on both raw and cooked
product contact surfaces during production. Once a day, the QC Manager
performs Microbial Monitoring for Total Plate Counts (TPCs). The QC
Manager swabs one square inch on a product contact surface from each of
three randomly selected pieces of equipment in each raw product room
and cooked product room.
Note: The samples are taken from the cooked product rooms first
and then from the raw product rooms. The samples are plated and
incubated at 35 deg. C. for 48 hours. Colonies are counted and
recorded as number of colony forming units (CFU) per square inch of
surface swabbed. Microbial counts are documented on Establishment
Form M-1.
3. Corrective Actions.
a. When the QC Manager identifies sanitation problems, the QC
Manager notifies the Processing Manager. The Processing Manager stops
production, if necessary, and notifies processing employees to take
appropriate action to correct the sanitation problems. If necessary,
processing employees are retrained. Corrective actions are recorded on
Establishment Form P-1.
[[Page 38875]]
If microbial counts exceed the action level set for each piece of
equipment for the specific product in that production line, the QC
Manager notifies the Processing Manager. The Processing Manager
attempts to determine the cause (for example, new people going back and
forth between the raw and cooked rooms, gloves not being changed
regularly) and takes corrective action. Additional daily microbial
sampling is done on any equipment that showed high microbial counts,
until the counts fall below the action level. If microbial counts
remain high for several days, the QC Manager confers with the
Processing Manager and Sanitation Manager to review all operations that
impact that equipment. The Processing Manager notifies the processing
employees and reviews personal hygiene and sanitary product handling
procedures. Corrective actions are recorded on Establishment Form P-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The monitoring and corrective actions are specific for Hill-Top Meats
only. Microbial sampling and monitoring are not required for product
contact surfaces. Each establishment determines its own procedures for
monitoring and the frequency of monitoring to include in its Sanitation
SOP.
------------------------------------------------------------------------
Appendix C--Guidebook for the Preparation of HACCP Plans
Preface
The Hazard Analysis Critical Control Points (HACCP) system is a
logical, scientific system that can control safety problems in food
production. HACCP is now being adopted worldwide. It works with any
type of food production system and with any food. It works by
controlling food safety hazards throughout the process. The hazards can
be biological, chemical, or physical.
This guidebook was developed to help meat and poultry
establishments prepare HACCP plans. The steps to developing a HACCP
plan can be used by all establishments, large or small, complex or
simple. The guidebook identifies additional sources of information, so
that small operators won't have to ``go it alone.''
The forms shown in this guidebook are examples only. Think of this
as a self-help guide or a do-it-yourself manual. There are many ways to
get to the final product--a good HACCP plan. So, choose the examples
that work best in your establishment.
The guidebook can be used to complement HACCP training. You may
also wish to use it in conjunction with a video about HACCP. The
guidebook will provide the basics. When you are ready to move on, there
are more specialized documents. FSIS is also publishing the Meat and
Poultry Products Hazards and Controls Guide. It explains in detail the
biological, chemical, and physical hazards that can occur at different
steps of meat and poultry slaughter and processing and provides some
examples of controls for those hazards. In addition, there will be a
series of Generic Models for different meat and poultry processes, to
be used as examples. You will probably want to look at the models for
processes that you use in your establishment. There will be model plans
for the following 13 processes:
Raw, Ground
Raw, Other
All Other Shelf-Stable, Heat Treated
Fully Cooked, Non-Shelf Stable
All Other Shelf-Stable, Not Heat Treated
All Non-Shelf Stable, Heat Treated, Not Fully Cooked
Non-Shelf Stable with Secondary Inhibitors
Thermally Processed/Commercially Sterile
Swine Slaughter
Poultry Slaughter
Beef Slaughter
Irradiation
Mechanically Separated Species
Developing a HACCP Plan
The Hazard Analysis and Critical Control Points (HACCP) System is a
logical, scientific approach to controlling safety problems in food
production. When a company adopts HACCP, it puts controls in place at
each point in the production system where safety problems could occur
from biological, chemical, or physical hazards. To start a HACCP
system, a company must first write a HACCP plan. This guidebook
explains how to write a HACCP plan in five preparatory steps and then
the seven HACCP principles.
The five ``pre-HACCP'' steps in this guidebook are:
1. Bring together your HACCP resources.
2. Describe the product and its method of distribution.
3. Develop a complete list of ingredients and raw materials used in
the product.
4. Develop a process flow diagram.
5. Meet the regulatory requirements for Sanitation Standard
Operating Procedures (SOPs).
Applying the seven HACCP principles makes up the major steps to
writing a HACCP plan. They are:
1. Conduct a hazard analysis.
2. Identify critical control points.
3. Establish critical limits for each critical control point.
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish recordkeeping procedures.
7. Establish verification procedures.
As you read this guidebook and look at the examples, the process
for writing a HACCP plan should become clearer. This first section of
the guidebook explains the five ``pre-HACCP'' steps. The next seven
sections cover each of the HACCP principles that you will need to
follow to develop a HACCP plan.
Pre-HACCP Step 1--Bring Together Your HACCP Resources
The first step is to assemble your HACCP resources. When a company
develops a HACCP plan, it is important to bring as much knowledge to
the table as possible. Actually, you probably have access to more HACCP
resources than you think! With a small establishment, this might mean
bringing together one or two employees, one of whom has had HACCP
training. Your HACCP resources may include outside expertise. You can
get this expertise through your local Extension Office, a trade or
professional association, or a contractor of your choice. A larger
plant may wish to bring in employees from a number of departments, such
as production, sanitation, quality control, and engineering, as well as
employees directly involved in daily processing activities. There is no
magic number of employees needed to write a HACCP plan. It could be one
employee or, in a very large company, it could be seven or eight
people.
Your employee or employees writing the HACCP plan should understand
some basic things about your establishment: The technology and
equipment used in your processing lines; the practical aspects of food
operations; and the flow of the process in your plant. It will be a
bonus for your HACCP plan if those employees have some knowledge of the
applied aspects of food microbiology and of HACCP principles and
techniques, although this knowledge can be supplemented by outside
experts.
Pre-HACCP Step 2--Describe the Product and Its Method of Distribution
The second step is to describe completely each food product that
your plant makes. This will help identify hazards that may exist either
in the ingredients or in the packaging materials.
To describe your product, you might ask the following questions
about the product:
1. Common name?
[[Page 38876]]
For example, a cooked sausage could be called franks/hot dogs/
wieners.
2. How is it to be used?
Categories might include: Ready-to-eat, to be heated prior to
consumption, or for further processing.
3. The type of package?
For example, is it modified atmosphere packaging?
4. Length of shelf life?
In the cooked sausage example, the length of shelf life might be 30
to 50 days for modified atmospheric packaging.
5. Where will it be sold?
For example, will it be sold to wholesale, retail or institutions?
6. Labeling instructions?
``Keep Refrigerated'' would be a common labeling instruction for
meat and poultry products.
7. Is special distribution control needed?
For instance, should the product be kept refrigerated at or below
40 deg.F? Below is a blank Product Description Form. It is an example.
You may take it and tailor it to your own establishment.
Below is an example of a Product Description Form filled in for
cooked sausage. The HACCP Generic Models developed for 13 different
processes will give you more samples of product descriptions.
Pre-HACCP Step 3--Develop a Complete List of Ingredients and Raw
Materials
The third step is to develop a written list of ingredients and raw
materials for each process/product. You can write this on a very simple
form, as shown below. You may wish to divide the ingredients into just
two categories: Meat (meat such as boneless beef or chicken parts with
skin) and Other Ingredients (such as spices and preservatives). Below
is a sample Product and Ingredients Form for chunked and formed,
breaded chicken patties. Again, these forms are only examples to get
you started. You may wish to have more elaborate forms for your
establishment. The important thing is to list all ingredients that go
into each product!
Pre-HACCP Step 4--Develop a Process Flow Diagram
The next step is to construct a process flow diagram that
identifies all the steps used to prepare the product, from receiving
through final shipment. The diagram should not be so complex that it is
difficult to follow and understand, but must be complete from the
beginning of your process to the end.
You will want to verify the process flow diagram. You do this by
actually walking through the plant to make sure that the steps listed
on the diagram describe what really occurs in producing the product.
A blank process flow diagram is shown below. It is a very simple
form on which you may want to draw the flow freehand. If you have a
computer, you can make a fancier form, with arrows leading from step to
step.
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An example of a Process Flow Diagram for cooked sausage is shown
below. The employees in this case chose to construct a flow diagram for
the meat and poultry ingredients, another one for the non-meat
ingredients, and a third flow diagram for supplies such as packaging
materials. You will find more examples of process flow diagrams for
specific products in the HACCP Generic Models.
Remember, the purpose of this diagram is to find any places in your
specific establishment where hazards could occur. As with all HACCP
planning forms, the approving employee should sign and date the form,
for your records.
Pre-HACCP Step 5--Meet the Regulatory Requirements for Sanitation
Standard Operating Procedures
Good sanitation is one of the most basic ways to ensure that you
produce safe products. Maintaining good sanitation serves as an
excellent and necessary foundation for building your HACCP plan. It
also demonstrates that you have the commitment and resources to
successfully implement your HACCP plan. Because it is so important,
meeting the regulatory requirements for Sanitation Standard Operating
Procedures (SOPs) is a pre-HACCP requirement that must be carried out
in all establishments. A separate guide and a model Sanitation SOP have
been prepared and are available to help you with this activity.
Now you are ready to apply the seven principles that will produce a
HACCP plan suited to your plant and your products. Those principles and
how to carry them out will be discussed in detail in the next seven
sections of this guidebook.
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Principle 1--Conduct a Hazard Analysis
HACCP Principle No. 1 states:
``Conduct a hazard analysis. Prepare a list of steps in the process
where significant hazards occur and describe the preventive measures.''
The regulation defines a food safety hazard as ``Any biological,
chemical, or physical property that may cause a food to be unsafe for
human consumption.''
This section will define the hazards and discuss in general where
they may occur in meat and poultry production. It will then talk about
identifying hazards in your establishment.
Finally, this section will explain how you can apply preventive
measures to the hazards you have identified, to ensure that the
products are safe for consumers. A preventive measure is defined, in
the regulation, as ``Physical, chemical, or other means that can be
used to control an identified food safety hazard.''
You will find a far more detailed listing of and discussion of
hazards in the Meat and Poultry Products Hazards and Controls Guide.
The generic HACCP models discuss the hazards specific to various meat
and poultry processes, such as raw, ground product or swine slaughter.
In addition, the References section of this guidebook lists
publications which can help you identify hazards.
To identify biological, chemical, or physical hazards likely to
occur, you need to know about the chemical, physical, and
microbiological characteristics of meat, poultry, and other
ingredients, as well as how various processes affect those
characteristics. You also need to understand the interactions among
ingredients.
You need to evaluate each step in the process flow diagram to
determine whether a biological, chemical and/or physical hazard may be
introduced at that step and whether preventive measures are available.
Biological Hazards
Biological hazards are living organisms, including microorganisms,
that can put human health at risk. Biological hazards include bacteria,
parasites, protozoa, viruses, and the like.
Agricultural products and food animals carry a wide range of
bacteria. From a public health standpoint, most bacteria are harmless.
Others--the pathogenic microorganisms--can cause illness or even death
in humans. The numbers and types of bacteria vary from one food or
animal species to another, from one geographic region to another, and
with production and slaughter or harvesting methods. During production,
processing, packaging, transportation, preparation, storage and
service, any food may be exposed to bacterial contamination. The most
common biological hazards in meat and poultry are microbiological.
Some of the major pathogenic bacterial organisms that can cause
foodborne illness from eating meat or poultry are: Salmonella,
Clostridium perfringens, Listeria monocytogenes, Staphylococcus aureus,
Campylobacter jejuni, Yersinia enterocolitica, Bacillus cereus,
Clostridium botulinum, and Escherichia coli O157:H7.
In the Meat and Poultry Products Hazards and Controls Guide, you
will find a brief description of the major microorganisms of concern in
meat and poultry. Table 1 in that guide describes the temperature and
pH ranges and the minimum water activity needed for each organism to
grow. Table 4 lists some preventive measures for biological hazards. To
thoroughly identify significant biological hazards in your
establishment, you need to evaluate each specific ingredient and
processing step in your operation.
Chemical Hazards
Chemical hazards may also cause foodborne illnesses.
Chemical hazards fall into two categories:
1. Naturally occurring poisons or deleterious substances are those
that are natural constituents of foods and are not the result of
environmental, agricultural, industrial, or other contamination.
Examples include aflatoxins, mycotoxins, and shellfish toxins.
2. Added poisonous or deleterious substances are those which are
intentionally or unintentionally added to foods at some point in
growing, harvesting, storage, processing, packing, or distribution.
This group of chemicals can include pesticides, fungicides,
insecticides, fertilizers, and antibiotics, as well as direct and
indirect food additives. This group can also include chemicals such as
lubricants, cleaners, paints, and coatings.
To identify any chemical hazards, you first need to identify any
chemical residues that might be in the animal. To do this, think about
the following:
The types of drugs and pesticides routinely used in
raising the animals which are the source of your meat and poultry
ingredients.
Feeds and supplements fed to the animals.
Environmental contaminants the animals may have come into
contact with. This includes both naturally occurring contaminants and
added contaminants.
Pesticides used on plants that may end up as residues in
the animal.
The source of the water the animals were allowed to drink.
You can use the following preventive measures to help ensure that
animals entering your establishment are free of harmful residues:
Require that the animals have been raised in conjunction
with the January 1994 FDA Compliance Policy Guidelines.
Require written assurances from suppliers for each lot of
animals, stating that the animals are free of illegal residues.
Set your own maximum allowable residue limits for specific
drugs, pesticides, and environmental contaminants in animal urine or
tissues as targets to ensure that FDA and EPA tolerances are met.
Ensure that trucks used to ship the animals do not have
chemical hazards that could contaminate the animals.
Most establishments use chemicals during processing and to keep
their operations sanitary. Yet you need to be aware that chemical
hazards can occur at any of the following points:
Prior to receiving chemicals at your establishment.
Upon receiving chemicals.
At any point where a chemical is used during processing.
During storage of chemicals.
During the use of any cleaning agents, sanitizers,
lubricants, or other maintenance chemicals.
Prior to shipment of the finished product.
In trucks used to ship finished product.
Some of the measures you can use to prevent chemical hazards are:
Use only approved chemicals.
Have detailed product specifications for chemicals
entering your plant.
Maintain letters of guarantee from suppliers.
Inspect trucks used to ship finished product.
Properly label and store all chemicals.
Properly train employees who handle chemicals.
In the Meat and Poultry Products Hazards and Controls Guide, Table
5 lists some preventive measures for chemical hazards. For still more
information, see the publication HACCP--Establishing Hazard Analysis
Critical Control Point Program, Food Processors Institute, 1993.
[[Page 38885]]
Physical Hazards
A physical hazard is any physical material not normally found in a
food which causes illness or injury to the individual using the
product. Physical hazards include a variety of foreign materials or
objects, such as glass, metal, and plastic. However, foreign objects
which cannot cause illness or injury are not hazards, even though they
may not be aesthetically pleasing to your customers.
A number of situations can result in physical hazards in finished
products. They include, but are not limited to:
Contaminated raw materials.
Poorly designed or poorly maintained facilities and
equipment. An example would be rust particles and paint chips falling
from overhead structures onto exposed product.
Improper procedures or improper employee training and
practices. For example, by using the wrong cutting technique during the
cut-up/prefabrication process, employees could cut off and leave pieces
of their rubber gloves in the product.
Measures you can take to prevent physical hazards include, but are
not limited to:
Make sure your plant specifications for building design
and operation are accurate and updated regularly.
Make sure your letters of guarantee for ingredients and
product supplies are accurate and updated regularly.
Perform random visual examinations of incoming product and
materials.
Use magnets and metal detectors to help find metal
fragments that would be a physical hazard.
Use stone traps and bone separators to remove these
potential physical hazards.
Keep equipment well maintained.
Train employees to identify potential problems.
To identify some preventive measures for physical hazards, see
Table 6 in the Meat and Poultry Products Hazards and Controls Guide.
Conducting a Hazard Analysis
Now that you have some understanding of the types of hazards that
can occur and how to identify and prevent them, you are ready to
conduct a hazard analysis for each process or product covered in your
HACCP plan.
A hazard analysis is the identification of any hazardous
biological, chemical, or physical properties in raw materials and
processing steps, and an assessment of their likely occurrence and
potential to cause food to be unsafe for consumption.
Your hazard analysis needs to be very specific to your
establishment and how you make your product, since hazards may vary
greatly from one establishment to another. This is due to differences
in: sources of ingredients, product formulations, processing equipment,
processing methods, duration of the processes and storage, and employee
experiences, knowledge, and attitudes.
You also need to review--and perhaps revise--your hazard analysis
whenever you make any changes in: raw materials suppliers, product
formulation, preparation procedures, processing steps, packaging
materials or procedures, distribution or intended use of the product.
Below is a blank Hazard Identification/Preventive Measures form
that you may wish to use for your hazard analysis. Below is an example
of that form filled in for hazards that might exist in a specific
establishment's ground beef process. The form contains space for the
process step in which the hazards could occur, the specific hazards,
and preventive measures to keep that hazard from occurring. Remember,
HACCP is a preventive system.
Steps in Conducting a Hazard Analysis
To conduct a hazard analysis, you need to do the following:
First--Evaluate Your Operation for Hazards
1. Review the product description developed in Pre-HACCP Step 2 and
determine how this information could influence your hazard analysis.
2. Look at all product ingredients and incoming materials for the
product. You developed this list in Pre-HACCP Step 3.
3. For each processing step identified in the process flow diagram,
determine if a biological, chemical or physical hazard(s) could exist
at that step.
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4. To help identify hazards, you can ask the following questions at
each processing step:
Could contaminants reach the product during this processing step?
Possibilities include: worker handling, contaminated equipment or
materials, cross-contamination from raw materials, leaking valves or
pipes, dead ends, splashing, etc.
Could any pathogens multiply during this process step to the point
where they became a hazard? Consider product temperature, hold time,
etc.
Could this step create a situation where an ingredient, work in
process, or finished product became contaminated with pathogens?
Could this step introduce a chemical hazard into the product?
Could this step introduce a physical hazard into the product?
5. Fully describe the hazards identified for each step.
6. For each incoming ingredient and material, indicate if a
biological, chemical and/or physical hazard exists.
7. To help identify hazards, you can ask the following questions
about each ingredient:
Could this ingredient contain any pathogenic microorganisms,
toxins, chemicals or physical objects?
If it became contaminated or were mishandled, could this ingredient
support the growth of pathogenic microorganisms?
Are any hazardous chemicals used in growing, harvesting, processing
or packaging the ingredient?
Is this ingredient hazardous if used in excessive amounts?
If this ingredient were left out or used in amounts lower than
recommended, could it result in microbial growth?
Are any chemical or physical hazards associated with this
ingredient?
8. You can ask the following questions about the product in
general:
Have any livestock entering the slaughter establishment been
subjected to hazardous chemicals?
Are any returned/reworked products used as ingredients?
If so, could they cause a hazard?
Are preservatives or additives used in the product formulation to
kill or inhibit the growth of microorganisms?
Do the amount and type of acid ingredients, and the resulting
product pH, affect the growth/survival of microorganisms?
Does the water activity of the finished product affect microbial
growth?
Should refrigeration be maintained for products during transit or
in storage?
Are any chemical or physical hazards associated with any packaging
materials?
9. Fully describe the hazards identified.
Second--Observe the Actual Operating Practices in Your Operation
After describing the hazards you've identified with each step, you
should:
1. Observe the actual operation in your establishment and be sure
that it is the usual process or practice.
2. Observe employee practices where raw or contaminated product
could cross-contaminate workers' hands, gloves or equipment used for
finished/post-process products.
3. Observe product handling past any kill step for potential cross-
contamination.
For additional information about potential biological, chemical,
and physical hazards, you may wish to consult tables 8 through 12 in
the Meat and Poultry Products Hazards and Controls Guide. They can
serve as a guide for identifying potential hazards in ingredients and
at various steps in slaughter and processing. However, they do not
address every ingredient and every processing step used in the meat and
poultry industry.
Preventive Measures
You have identified all significant biological, chemical and
physical hazards for each processing step and each ingredient. Now, it
is time to identify measures to prevent hazards from compromising the
safety of your finished product. Remember, you may not be able to
identify a preventive measure for every hazard that you identified. You
are ready to fill in the preventive measure(s) column of the Hazard
Identification/Preventive Measures Form.
Remember, HACCP defines a preventive measure as ``Physical,
chemical, or other means that can be used to control an identified food
safety hazard.''
Some examples of preventive measures are:
In beef slaughter, a chemical hazard could result from animals
having high levels of drug residues. As a preventive measure, you could
test the animals or require letters of guarantee from producers that
the animals are free of harmful residues.
In poultry slaughter, the venting, opening and evisceration process
could result in a biological hazard from cross contamination by
pathogenic microorganisms. Preventive measures for this hazard would
be: use Good Manufacturing Practices (GMP's) at all times; properly
maintain and operate equipment used to perform these tasks; and rinse
food contact surfaces on equipment with chlorinated water between each
carcass.
In the grinding step for cooked sausage, a physical hazard could be
metal fragments from the grinding equipment. There could be three
different preventive measures for this hazard. You could inspect the
grinding equipment daily to ensure that it is assembled and operated
correctly, is functioning properly, and is not worn or damaged. You
could have an employee visually examine the product at the packaging
step. Or you could use a metal detector at the packaging step.
In many operations, the packaging step could pose chemical hazards
from the packaging materials. A preventive measure could be a letter of
guarantee from the supplier that the packaging materials are all food
grade.
Once you have identified your preventive measures and written them
on your form, you are ready to go on to the next step in developing
your HACCP plan. See blank and filled-in forms for preventive measures
below.
Principle 2--Identify Critical Control Points
HACCP Principle No. 2 states:
``Identify the Critical Control Points (CCPs) in the process.''
A critical control point (CCP) is defined as ``A point, step, or
procedure in a food process at which control can be applied and, as a
result, a food safety hazard can be prevented, eliminated, or reduced
to acceptable levels.''
So far, in developing your HACCP plan, you have identified
biological, chemical, and physical hazards in the raw materials and
ingredients you use and in the steps of your process. You've also
identified preventive measures, if they exist, for each hazard that you
identified. With this information, your next step is to identify the
points in the process at which the preventive measures can be applied
to prevent, eliminate, or reduce the hazard. Then you can use the CCP
Decision Tree to assess each step in the process to determine whether
it is a critical control point. (Many control points may not be
critical; often, companies starting out in HACCP identify too many
control points.)
Fortunately, a great deal of work has already been done for you in
identifying CCPs. Many CCPs are already recognized in various food
processing and production systems. Some common CCPs are:
Chilling.
Cooking that must occur for a specific time and
temperature in order to destroy microbiological pathogens.
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Product formulation controls, such as mixing ground beef
and spices to form a meatball.
Certain processing procedures, such as filling and sealing
cans.
Prevention of cross contamination between raw and cooked
product.
Certain slaughter procedures, such as evisceration.
These are just a few examples of measures that may be CCPs.
There are many more possibilities. Different facilities, preparing
the same food, can differ in the number and location of hazards and the
points, steps or procedures which are critical control points. This is
due, in part, to differences in plant layouts, equipment used,
selection and sources of raw materials and ingredients, or the process
that is used.
Steps in Identifying Critical Control Points
A good tool for identifying Critical Control Points is the CCP
Decision Tree, shown below. The CCP Decision Tree was developed to help
companies separate CCPs from other controls. You will get the best
results if you use the Decision Tree very methodically and use simple,
descriptive, and familiar wording. You should apply the Decision Tree
at each step in the process where you have identified a hazard.
You can use the blank Critical Control Point Determination Form, to
record the results from your CCP Decision Tree work. Or, you may wish
to design your own form. An example of a filled-in Critical Control
Point Determination Form for poultry slaughter at one establishment is
shown below.
Determining whether a process step is a CCP is really a basic
exercise of answering four questions. To use the form and the Decision
Tree, follow the next six steps:
1. In Column 1 of the Critical Control Point Determination Form,
write in each step in the process where you have identified a hazard.
2. In Column 2, write in the identified hazard(s), indicating
whether it is biological, chemical or physical. Then take the
information you wrote on your Hazard Identification/Preventive Measures
form and answer the following questions for each hazard you identified.
3. Question #1--Do preventive measures exist for the identified
hazard?
Note: From a regulatory standpoint, no further action is
necessary if the hazard is not reasonably likely to occur.
If the answer is yes, write YES and proceed to the next question.
If the answer is no, ask the question ``Is control at this step
necessary for safety?''
If control is not necessary at this step in the process, this
process step is not a CCP. Write NO in Column 3 and write how and where
this hazard will be controlled. Proceed to the next process step and
identified hazard you have entered in Columns 1 and 2.
If control is necessary, in Column 3 explain how the step, process
or product will be modified to ensure safety.
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Once the step, process, or product has been modified, return to
Question #1.
4. Question #2--Does this step eliminate or reduce the likely
occurrence of the hazard(s) to an acceptable level?
If the answer is yes, write YES in Column 4 and identify the step
as a CCP in Column 7.
If the answer is no, write NO in Column 4 and proceed to the next
question.
5. Question #3--Could contamination with identified hazard(s) occur
in excess of acceptable levels or could these increase to unacceptable
levels?
If the answer is yes, write YES in Column 5 and proceed to the next
question.
If the answer is no, write NO in Column 5, indicating that the step
is not a CCP. Then proceed to the next process step and hazard.
6. Question #4--Will a subsequent step eliminate identified
hazard(s) or reduce the likely occurrence to an acceptable level?
If the answer is yes, write YES in Column 6, indicating that the
step is not a CCP. Then write down which processing step, which occurs
later, will reduce the hazard to acceptable levels. Then proceed to the
next process step and hazard.
If the answer is no, write NO in Column 6 and identify the step as
a CCP in Column 7.
Principle 3--Establish Critical Limits for Each Critical Control Point
HACCP Principle No. 3 states:
``Establish critical limits for preventive measures associated with
each identified CCP.''
The regulation defines critical limit as ``The maximum or minimum
value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce
to an acceptable level the occurrence of the identified food safety
hazard.''
Critical limits are expressed as numbers, such as:
Time/temperature
Humidity
Water activity
pH
Salt concentration
Chlorine level
You will find that many critical limits for your identified CCPs
have already been established. You can find these limits in sources
such as regulatory requirements, scientific literature, experimental
studies, and through consultation with experts. Some examples of
regulatory critical limits for CCPs in meat and poultry production are
shown in Table 7 of the Meat and Poultry Products Hazards and Controls
Guide.
You may wish to establish critical limits that are stricter than
regulatory requirements. However, your critical limits must never be
less stringent than the requirements.
In some cases, you will need more than one critical limit to
control a particular hazard. For example, the critical limits for
cooked beef patties are time/temperature, pattie thickness, and
conveyor speed.
Below you will find an example of a Critical Limits, Monitoring and
Corrective Actions Form. You can use that form, or develop your own, to
use in this and the following two sections. You will find an example of
that form filled in for swine slaughter in one establishment below. You
can find examples of critical limits for specific processes in the
HACCP Generic Models.
Steps in Establishing Critical Limits
1. For each identified CCP, determine if there is a regulatory
critical limit. If so, write that critical limit--or a more stringent
one--into the critical limit column of your form.
For example, the regulatory critical limit for chilled poultry is
40 degrees F. So, for the chilling CCP in poultry slaughter, you would
write, in the Critical Limit column of your form: ``Deep breast muscle
temperature of 40 degrees F. as the carcasses exit the
chiller.''
2. If there are no regulatory critical limits for a CCP, you need
to establish critical limits for the CCP that are adequate to maintain
control and prevent a food safety hazard. That is the responsibility of
each establishment. You may wish to obtain the assistance of outside
HACCP experts to help you determine critical limits for your CCPs. Once
you have identified critical limits, enter them into the critical limit
column of your form.
3. You should also file, for future reference, any documentation
such as letters from outside HACCP experts or scientific reports
supporting the critical limits you have identified. This documentation
will help validate that the limits have been properly established. In
addition, you should keep on file any test results that show your early
experience in implementing the HACCP plan, to demonstrate you can
implement what is written and make it work.
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Principle 4--Establish Monitoring Procedures
HACCP Principle No. 4 states:
``Establish CCP monitoring requirements. Establish procedures for
using the results of monitoring to adjust the process and maintain
control.''
Monitoring is a planned sequence of observations or measurements to
assess whether a CCP is under control and to produce an accurate record
for future use in verification.
Monitoring is essential to a HACCP system. Monitoring can warn you
if there is a trend towards loss of control, so that you can take
action to bring your process back into control before a critical limit
is exceeded. For example, say that an establishment tests the pH of a
batch of product at 6 a.m., 7 a.m., and 8 a.m. Each time, the pH is
within acceptable limits, but it is steadily climbing towards the high
end of the range. This information is showing a trend and the
establishment should take action to prevent the pH from exceeding the
critical limits.
The monitoring procedures you will establish at CCPs will generally
relate to on-line processes. Monitoring may be continuous or non-
continuous. Continuous monitoring at a CCP usually is done with
measuring equipment, such as automatic time-temperature equipment used
at a cooking step. Continuous monitoring is better because it results
in a permanent record that you can review and evaluate to ensure that
the CCP is under control. However, you should regularly check
continuous monitoring equipment for accuracy.
You should use non-continuous monitoring procedures when continuous
monitoring is not feasible. Non-continuous monitoring can include:
visual examinations; monitoring of ingredient specifications;
measurements of pH, water activity (Aw), and product temperatures;
attribute sampling; and the like. When you use non-continuous
monitoring, you need to ensure that the frequency of monitoring is
enough to ensure that the hazard is under control and that the
monitoring is performed at random times. For instance, each plant needs
to set its own times and frequency for checking the cooking time/
temperature of products. This may vary from one establishment to
another because of differences in plant size, plant layout, the type of
product, the length of time for processing, and the product flow.
Each establishment has the responsibility to establish a frequency
that ensures that the CCP is under control. In some cases, you may have
to perform tests at a CCP or use statistically based sampling.
Monitoring will go much more smoothly if you:
Clearly identify the employee(s) responsible for
monitoring.
Train the employee(s) monitoring the CCPs in the testing
procedures, the critical limits established, the methods of recording
test results, and actions to be taken when critical limits are
exceeded.
Ensure that the employee(s) understand the purpose and
importance of monitoring.
You can use the Critical Limits, Monitoring and Corrective Actions
Form shown below, or you can develop your own form. Below is an example
of a form filled in for swine slaughter in one establishment.
Steps in Establishing Monitoring Procedures
You can identify monitoring procedures for your HACCP plan by doing
the following:
1. For each CCP, identify the best monitoring procedure.
2. Determine the frequency of monitoring for each CCP.
3. Determine if the monitoring activity needs to be done randomly
to get a good representation of the product throughout the day's
production. If it does, decide how the random monitoring will be done.
4. Determine what testing procedures need to be done for each
monitoring function. For example, will you need to do a chlorine check
or a temperature measurement?
5. Identify and train the employee(s) responsible for monitoring.
6. Make sure that the employee doing the monitoring signs all
records and documents associated with CCP monitoring. Also make sure
that the monitoring results are documented or recorded at the time the
monitoring takes place.
7. Enter the above information in the monitoring column of your
form.
Principle 5--Establish Corrective Actions
HACCP Principle No. 5 states:
``Establish corrective action to be taken when monitoring indicates
that there is a deviation from an established critical limit.''
The regulation defines corrective action as ``Procedures to be
followed when a deviation occurs.''
A deviation is a failure to meet a critical limit.
Since HACCP is a preventive system to correct problems before they
affect the safety of the food, you have to plan in advance to correct
potential deviations from established critical limits. Once your HACCP
plan is in place, any time a critical limit is not met, you will need
to take corrective actions. Those corrective actions should include:
1. Determining the disposition of non-complying product;
2. Correcting the cause of the non-compliance to prevent a
recurrence;
3. Demonstrating that the CCP is once again under control (this
means examining the process or product again at that CCP and getting
results that are within the critical limits);
4. Maintaining records of the corrective actions.
Under HACCP, you determine in advance what you will do when a
critical limit is not met at a CCP. The employee(s) monitoring CCPs
should understand this process and be trained to perform the
appropriate corrective actions. It is important that an establishment
record all corrective actions and that the employee responsible for
taking the corrective actions sign all the documentation.
In some cases, the product in question will be held for further
investigation of the deviation. This investigation may require a
thorough record review, product testing, or consultation with a
processing authority.
Some examples of corrective actions are:
Immediately adjust the process and hold product for
further evaluation and disposition.
Empower employees to stop the line when a deviation
occurs, hold all product not in compliance, and call in the plant's
quality control manager.
Rely on an approved alternate process that can be
substituted for the one that is out of control at the specific critical
control point. For example, if the in-line eviscerators in a poultry
slaughter plant are malfunctioning, evisceration can be done by hand as
long as Good Manufacturing Practices (GMPs) are followed.
Regardless of the corrective actions you take, you need to keep
records that include:
The deviation that was identified.
The reason for holding the product; the time and date of
the hold; the amount of product involved; the disposition and/or
release of product; and the individual who made the disposition
decision.
Actions to prevent the deviation from recurring.
You can use the Critical Limits, Monitoring and Corrective Actions
form below or you can develop your own
[[Page 38897]]
form. A sample form, filled in for swine slaughter, appears below.
Steps in Establishing Corrective Actions
1. For each CCP, determine the corrective action to take if the
critical limits are exceeded. Determine what should be done with the
product if a deviation occurs at this step. You may need more than one
corrective action for a CCP.
2. Develop the record form to capture all the necessary information
on the deviation, and identify the employee responsible for maintaining
and signing the record.
3. Ensure that employees conducting the monitoring at each CCP are
fully trained and know the corrective actions to take if a deviation
occurs.
4. Enter the appropriate corrective action(s) for each CCP in the
corrective action column of the Critical Limits, Monitoring and
Corrective Actions form and identify the record that will be
maintained.
Principle 6--Establish Recordkeeping Procedures
HACCP Principle No. 6 states:
``Establish effective recordkeeping procedures that document the
HACCP system.''
Maintaining proper HACCP records is an essential part of the HACCP
system. Good HACCP records--meaning that they are accurate and
complete--can be very helpful to you for the following reasons:
Records serve as written documentation of your
establishment's compliance with its HACCP plan.
Records allow you to trace the history of an ingredient,
in-process operations, or a finished product, should problems arise.
Records help you identify trends in a particular operation
that could result in a deviation if not corrected.
If you were ever faced with a product recall, HACCP
records could help you identify and narrow the scope of such a recall.
Well-maintained records are good evidence in potential
legal actions against an establishment.
In accordance with the HACCP principles, your HACCP system should
include records for CCPs, establishment of critical limits, handling of
deviations, and your HACCP plan. Examples of these and other HACCP
forms that may be useful in assembling the HACCP plan are located in
the appropriate sections of this guidebook. For your review, these
forms are:
Product(s) Description Form
Product and Ingredients Form
Process Flow Diagram Form
Hazard Identification/Preventive Measures Form
CCP Determination Form
Critical Limits, Monitoring and Corrective Actions Form
Recordkeeping and Verification Form (Verification will be explained in
the next section of this guidebook)
HACCP Plan Form
In many cases, the records you currently maintain may be sufficient
to document your HACCP system. Records must contain at least the
following information: title and date of record; product
identification; critical criteria or limits; a line for the monitor's
signature; a place for the reviewer's signature; and, an orderly manner
for entering the required data.
An example of a blank Recordkeeping and Verification Form is found
below. Also below is an example of the form filled in for cooked
sausage in one establishment.
Steps in Establishing Recordkeeping Procedures
1. Review the records you currently maintain and determine which
ones adequately address the monitoring of the CCPs you have identified,
or develop forms for this information.
2. Develop any forms necessary to fully record corrective actions
taken when deviations occur.
3. Develop forms to document your HACCP system. (This will be
explained in the next section, on verification).
4. Identify the monitoring employees responsible for entering data
into the records and ensure that they understand their roles and
responsibilities.
5. Enter the record form name(s) on the Recordkeeping and
Verification Form under the records column adjacent to the appropriate
CCP. (Verification will be explained in the next section).
6. Enter the appropriate record form name(s) on the Recordkeeping
and Verification Form under the verification procedures column adjacent
to the appropriate CCP. (Verification will be explained in the next
section).
Principle 7--Establish Verification Procedures
HACCP Principle No. 7 states:
``Establish procedures to verify that the HACCP system is working
correctly.''
After a HACCP plan has been put into place, verification activities
occur on an ongoing basis. Verification entails the use of methods,
procedures, or tests in addition to those used in monitoring, to
determine whether the HACCP system is operating as intended.
Simply stated, you need to verify that your HACCP system is working
the way you expected it to work. There are several areas that warrant
checking. You will probably first want to review your HACCP plan to
determine whether the CCPs and critical limits that you established are
really the right ones and that you are controlling and monitoring them
adequately. You should also make sure that employees are following your
procedures for taking corrective actions when a critical limit is
exceeded. Finally, you should check to see that your employees are
keeping good HACCP records.
By doing these things, you will evaluate the day-to-day operation
of your HACCP system. Don't be surprised if you find that you need to
fine-tune your HACCP plan.
Some things you can do to verify your HACCP system are:
Analytically test or audit your monitoring procedures;
Calibrate your temperature equipment;
Sample your product, including microbiological sampling;
Review your monitoring records;
Review your records of deviations and product
dispositions;
Inspect and audit your establishment's operations;
Sample for environmental and other concerns.
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You can use the Recordkeeping and Verification Form to record your
verification procedures. A sample blank form appears below. An example
filled in for cooked sausage in one establishment appears below.
Steps in Establishing Verification Procedures
1. Determine the appropriate verification procedure to ensure that
each CCP and critical limit is adequately controlled and monitored.
2. For each CCP, determine procedures to ensure that employees are
following your established procedures for handling product deviations
and for recordkeeping.
3. Identify the frequencies for conducting any verification checks
and the records where the results will be recorded.
4. Enter the appropriate details on the Recordkeeping and
Verification Form for future reference.
Validate Your HACCP Plan
It is very important to validate your HACCP plan. The regulation
defines validation as ``the scientific and technical process for
determining that the CCPs and associated critical limits are adequate
and sufficient to control likely hazards.''
Simply put, when you validate your HACCP plan, you demonstrate that
what you have written and put into place can actually prevent,
eliminate, or reduce the levels of hazards that you have identified.
To validate your HACCP plan, you need to assemble information to
show that your HACCP plan will work to control the process and to
prevent food safety hazards. There are two types of information that
you will probably collect. First, you will likely gather supporting
scientific information, such as studies that establish the time and
temperatures necessary to kill certain harmful bacteria. Second, you
may wish to gather practical information, such as test results from
products produced under your HACCP plan. An example of a test might be
microbiological analysis of your finished, ready-to-eat products. There
are many sources of information to validate your HACCP plan, including:
the scientific literature, product testing results, experimental
research results, scientifically-based regulatory requirements,
official FSIS guidelines, or information developed by process
authorities.
You have a great deal of flexibility in assembling the information
to validate your plan, in terms of both source and quantity of
information. For example, a slaughter plant should validate that its
plan ensures residue control, to prevent violative levels of chemicals,
animal drugs or pesticides in carcasses. A slaughter plant might choose
to purchase animals only from suppliers who provide veterinary
certifications that the animals have been raised under a program that
assures that all animal drugs, pesticides, and other chemicals are
properly used. In this situation, the establishment could validate this
critical control point with the following information: a copy of the
residue prevention program under which the producer is certified; a
report of an on-site visit to the feedlot; and results of analyses of
carcasses for compounds of concern.
Validation is simpler for HACCP plans for products such as cooked
beef, roast beef, or cooked corned beef. Current regulatory
requirements for these products include scientifically-based processing
times, temperatures, and handling requirements. Your HACCP plan would
need only to reflect these regulatory requirements; additional
information would be unnecessary. In this case, you could do a minimal
number of product analyses to demonstrate that hazards of concern, such
as Salmonella, were not found in the products produced under the HACCP
plan.
It is important that you reassess your HACCP plan at least once a
year and whenever any of the following occurs:
1. Potential new hazards are identified that may be introduced into
the process for the product.
2. You add new ingredients.
3. You change the process steps or procedures.
4. You introduce new or different processing equipment.
Finishing Your HACCP Plan
Now you are ready to assemble all your information into one HACCP
Plan. A sample HACCP Plan blank form is provided below. An example of a
form filled in for one establishment's canned beef stew process is
shown below. It is important for your records that you assemble all
your information into a final HACCP plan. To make sure that your HACCP
Plan is complete, you may want to check it against the checklist
provided in the next section of this guidebook.
Now you are ready to put your HACCP Plan into action and make HACCP
a reality in your establishment.
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HACCP Plan Checklist
You can use the HACCP Plan Checklist provided in this section to
ensure that your HACCP plan adequately addresses all seven HACCP
principles.
When completing the checklist, if you answer ``NO'' to any
question, you reevaluate that section of the HACCP plan and make
whatever modifications are necessary. Some modifications may require
the assistance of recognized HACCP experts.
Any time you make major changes to the HACCP plan based upon
product or process modifications, it would be advisable to review the
checklist to ensure that the revisions are acceptable.
You can keep the HACCP Plan Checklist as part of your HACCP plan
for future reference and to provide documented evidence that your HACCP
plan addresses all seven HACCP principles.
ESTABLISHMENT NO.------------------------------------------------------
PRODUCT/PROCESS--------------------------------------------------------
DATE-------------------------------------------------------------------
HACCP Plan Checklist
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
A. DESCRIBE THE PRODUCT YES NO
1. Does the HACCP plan include:
a. The producer/establishment and the product name?
b. The ingredients and raw materials used along with the product receipt or formulation?
c. The packaging used?
d. The temperature at which the product is intended to be held, distributed and sold?
e. The manner in which the product will be prepared for consumption?
2. Has a flow diagram for the production of the product been developed that is clear,
simple, and descriptive of the steps in the process?
3. Has the flow diagram been verified for accuracy and completeness against the actual
operating process?
B. CONDUCT A HAZARD ANALYSIS YES NO
1. Have all steps in the process been identified and listed where hazards of potential
significance occur?
2. Have all hazards associated with each identified step been listed?
3. Have safety concerns been differentiated from quality concerns?
4. Have preventive measures to control the identified hazard been identified, if they exist,
and listed?
C. IDENTIFY CRITICAL CONTROL POINTS YES NO
1. Has the CCP Decision Tree been used to help determine if a particular step is a CCP for a
previously identified hazard?
2. Have the CCPs been entered on the forms?
3. Have all significant hazards identified during the hazard analysis been addressed?
D. ESTABLISH CRITICAL LIMITS YES NO
1. Have critical limits been established for each preventive measure at each CCP?
2. Has the validity of the critical limits to control the identified hazard been
established?
3. Were critical limits obtained from the regulations, processing authority, etc?
4. Is documentation attesting to the adequacy of the critical limits maintained on file at
the establishment?
E. ESTABLISH MONITORING PROCEDURES YES NO
1. Have monitoring procedures been developed to assure that preventive measures necessary
for control at each CCP are maintained within the established critical limits?
2. Are the monitoring procedures continuous or, where continuous monitoring is not possible,
is the frequency of monitoring sufficiently reliable to indicate that the hazard is under
control?
3. Have procedures been developed for systematically recording the monitoring data?
4. Have employees responsible for monitoring been identified and trained?
5. Have employees responsible for reviewing monitoring records been identified and trained?
6. Have signatures of responsible individuals been required on the monitoring records?
7. Have procedures been developed for using the results of monitoring to adjust the process
and maintain control?
F. ESTABLISH CORRECTIVE ACTIONS YES NO
1. Have specific corrective actions been developed for each CCP?
2. Do the corrective actions address:
a. Reestablishment of process control?
b. Disposition of affected product?
c. Procedures to correct the cause of non-compliance and to prevent the deviation from
recurring?
3. Have procedures been established to record the corrective actions?
4. Have procedures been established for reviewing the corrective action records?
G. ESTABLISH RECORDKEEPING PROCEDURES YES NO
1. Have procedures been established to maintain the HACCP plan on file at the establishment?
2. Do the HACCP records include:
Description of the product and its intended use?
Flow diagram for the process, indicating CCPs?
Preventive measures?
Critical limits?
Monitoring system:
Corrective action plans for deviations from critical limits?
Recordkeeping procedures for monitoring?
Procedures for verification of the HACCP system?
H. ESTABLISH VERIFICATION PROCEDURES YES NO
1. Have procedures been included to verify that all significant hazards were identified in
the HACCP plan when it was developed?
2. Have procedures been included to verify that the critical limits are adequate to control
the identified hazards?
3. Are procedures in place to verify that the HACCP system is functioning properly?
[[Page 38904]]
4. Are procedures in place to reassess the HACCP plan and system on a regular basis or
whenever significant product, process or packaging changes occur?
----------------------------------------------------------------------------------------------------------------
References
Agriculture Canada. Food Safety Enhancement Program--
Implementation Manual. Camelot Drive, Nepean, Ontario, Canada.
American Meat Institute Foundation. HACCP: The Hazard Analysis and
Critical Control Point System in the Meat and Poultry Industry.
1994. Washington, D.C.
Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease
outbreaks in the United States, 1973-1987: Pathogens, vehicles, and
trends.'' J. Food Protect. 53: 804-817.
Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease
outbreaks, 5-year summary, 1983-1987.'' J. Food Protect. 53: 711.
Corlett, D.A., Jr. and R.F. Steir. 1991. ``Risk assessment
within the HACCP system.'' Food Control 2:71-72.
Council for Agricultural Science and Technology. Risks
Associated with Foodborne Pathogens. February 1993.
Environmental Protection Agency. 1992. Tolerances for Pesticides
in Foods. Title 40, Code of Federal Regulations, Part 185. U.S.
Government Printing Office, Washington, DC.
FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington,
DC.
FDA. 1994. Fish and Fishery Products Hazards and Control Guide--
Get Hooked on Seafood Safety. Office of Seafood. Washington, DC.
International Commission on Microbiological Specification for
Foods. 1989. Microorganisms in Foods 4. Application of hazard
analysis and critical control point (HACCP) system to ensure
microbiological safety and quality. Blackwell Scientific
Publications, Boston.
National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). March 20, 1992--Hazard Analysis and Critical Control
Point System. Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). June 1993--Report on Generic HACCP for Raw Beef.
Food Micr. 10: 449-488.
Oblinger, J. L., ed. 1988. ``Bacteria Associated with Foodborne
Illnesses, A Scientific Status Summary by the Institute of Food
Technologists Expert Panel on Food Safety and Nutrition.'' Food
Technol. 42(4).
Padhye, N. V.; Doyle, M. P. 1992. ``E. Coli 0157:H7
Epidemiology, pathogenesis, and methods for detection in food.'' J.
Food Prot. 55:55-565.
Pierson, M. D. and Corlett, D. A., Jr. ed. 1992. HACCP/
Principles and Applications. Van Nostrand Reinhold.
Schuchat, A., Swaminathan, B. And Broome, C.V. 1991.
``Epidemiology of human listeriosis.'' Clin. Microbiol. Rev. 4: 169-
183.
Stevenson, K. E. ed. 1993. HACCP-Establishing Hazard analysis
Critical Control Point Programs. A Workshop Manual. The Food
Processors Institute. Washington, D.C.
Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth. I.K.
1988. ``Campylobacter isolates in the United States, 1982-1986.''
In, CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS- 2) : 1-
13.
Tauxe, R. V., Epidemiology of Camplyobacter jejuni infections in
the United States and other Industrialized Nations. In Nachamkin,
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and
Future Trends, 1994, chapter 2, pages 9-19.
Todd, E. 1990. ``Epidemiology of Foodborne Illness: North
America.'' The Lancet 336:788.
Tompkin, R. B. 1990. ``The Use of HACCP in the Production of
Meat and Poultry Products. J. of Food Protect.'' 53(9): 795-803.
Tompkin, R. B. 1995. The Use of HACCP for Producing and
Distributing Processed Meat and Poultry Products. In Advances in
Meat Research. Volume 10. Hazard Analysis Critical Control Point
(HACCP) in Meat, Poultry and Seafoods. Chapman & Hall (In Press).
USDA, 1994. List of Propriety Substances and Nonfood Compounds
Authorized for Use under USDA Inspection and Grading Programs. USDA,
FSIS, Washington, DC.
Internet Home Pages
Agriculture Canada
http://aceis.agr.ca
Center for Disease Control
http://fftp.cdc.gov/pub/mmwr/MMWRweekly
Food Law Sites
http://www.fsci.umn.edu/FoodLaw/foodlaw.html
HACCP95
http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html
International Meat and Poultry HACCP Alliance
http://ifse.tamv.edu./haccpall.html
Material Safety Data Sheets
http://listeria.nwfsc.noaa.gov/msds.html
U.S. Department of Agriculture
http://www.usda.gov
U.S. Food and Drug Administration/Bad Bug Book
http://vm.cfsan.fda.gov/list.html
Appendix D--Hazards and Preventive Measures Guide
Preface
This Guide is designed to help a plant's HACCP team conduct a
hazard analysis (HACCP Principle 1) by providing both general and
detailed information on hazards associated with meat and poultry
products and by listing some of the controls that can be used to
prevent or manage those hazards. When using this Guide it is very
important to remember that it is not all-inclusive: There may be other
hazards associated with ingredients or processes; there may be other
control measures. The examples assembled here are to help plant HACCP
teams think through all the hazards that could affect their product and
know about various controls that can be used.
Section I describes some of the biological (including
microbiological), chemical, and physical hazards generally recognized
and associated with meat and poultry products. This section can serve
as a resource when the HACCP team begins the hazard analysis. It is
probably useful to read through this general information early in the
process of developing the HACCP plan. This will help the team form an
idea of what is meant by a given hazard.
Section II provides information on generally recognized preventive
measures used in the meat and poultry industry to control biological,
chemical, and physical hazards. This section also has examples of
regulatory critical limits associated with some preventive measures.
Sections III, IV, and V list processing steps, hazards, and
controls for beef, poultry, and swine slaughter. This section should be
used with the process flow diagram developed by the HACCP team.
Section VI presents hazards and controls organized according to
ingredients, including both meat and poultry ingredients and other
ingredients used in meat and poultry production. This section should be
used with the list of ingredients developed by the HACCP team.
Section VII contains a set of tables identifying potential hazards
at various processing steps used to produce meat and poultry products.
This section should be used with the process flow diagram developed by
the plant's HACCP team.
Section VIII contains a list of valuable references that will help
the plant's HACCP team further develop the HACCP plan.
Section I
Overview of Biological, Chemical, and Physical Hazards
In a HACCP system, a hazard is defined as a biological, chemical,
or physical property that may cause a food
[[Page 38905]]
to be unsafe for human consumption. This guide is a reference for plant
HACCP teams to use in their hazard identification and analysis. It is
not intended to be totally inclusive; the team may have other
information or may rely on additional references.
Biological Hazards
Biological hazards, which are mainly bacterial, can cause either
foodborne infections or intoxications. A foodborne infection is caused
by a person ingesting a number of pathogenic microorganisms sufficient
to cause infection as a result of their multiplication, e.g.,
salmonellosis. A foodborne intoxication is caused by the ingestion of
already formed toxins produced by some bacteria when they multiply in
food, e.g., staphylococcal enterotoxin.
When assessing bacterial hazards to human health in meat and
poultry products, nine pathogenic bacteria must be considered. The
following identifies and discusses the nine pathogenic microorganisms
of concern.
Bacillus cereus
B. cereus foodborne intoxication includes two recognized types of
illness--diarrheal and emetic (vomiting).
Foods associated with illness include: Boiled and fried rice,
custards, cecal products meats, vegetables, and fish; food mixtures
such as sauces, puddings, soups, casseroles, pastries, and salads.
Campylobacter jejuni
Campylobacteriosis is the illness caused by C. jejuni. It is also
often known as campylobacter enteritis or gastroenteritis.
Food associated with illness include: raw and undercooked chicken,
raw milk, non-chlorinated water.
Clostridium botulinum
Foodborne botulism (as distinct from wound botulism and infant
botulism) is a severe foodborne disease caused by the ingestion of
foods containing the potent neurotoxin formed during growth of the
organism. Botulism has a high mortality rate if not treated immediately
and properly.
Foods associated with disease include: sausages, meat products, and
seafood products, improperly canned foods, vegetable products.
Clostridium perfringens
Perfringens foodborne illness is the term used to describe the
common foodborne disease caused by the release of enterotoxin during
sporulation of C. perfringens in the gut.
Foods associated with illness include: meat and poultry products
and gravy.
Escherichia coli O157:H7
Hemorrhagic colitis is the name of the acute disease caused by E.
coli O157:H7.
Foods associated with illness: undercooked or raw hamburger (ground
beef) has been implicated in many documented outbreaks and in other
sporadic cases; other meat products, raw milk, untreated water.
Listeria monocytogenes
Listeriosis is the name of the general group of disorders caused by
L. monocytogenes.
Foods associated with illness: cole slaw, cooked poultry, cooked
meat, and raw milk, supposedly pasteurized fluid milk, cheeses
(particularly soft-ripened varieties). Its ability to grow at
temperatures as low as 3 deg.C permits multiplication in refrigerated
foods.
Salmonella spp
S. typhi and the paratyphoid bacteria are normally septicemic and
produce typhoid or typhoid-like fever in humans and are pathogenic only
for humans. Other forms of salmonellosis generally produce milder
symptoms. The organism is found in the intestinal tracts of warm
blooded animals.
Foods associated with illness: raw and cooked meats, poultry, eggs
(and exterior of egg shells), untreated water, raw milk and dairy
products, fish, shrimp, frog legs, yeast, sauces and salad dressing,
etc.
Staphylococcus aureus
Staphylococcal food poisoning (staphylococcal enterotoxicosis;
staphylococcal enterotoxemia) is the name of the condition caused by
the enterotoxins that some strains of S. aureus produce.
Foods associated with illness: meat and meat products; poultry and
egg products; egg, tuna, ham, chicken, potato, and macaroni salads;
sandwich fillings; milk and dairy products; etc.
Yersinia enterocolitica
Yersiniosis is the name of the disease caused by pathogenic species
in the genus Yersinia. The disease is a gastroenteritis with diarrhea
and/or vomiting, and fever and abdominal pain.
Foods associated with illness: meats, oysters, fish, milk, and
chitterlings.
Table 1.--Characteristics of Growth for Nine Pathogens Associated With Meat and Poultry Products
----------------------------------------------------------------------------------------------------------------
Temperature of
Pathogens growth pH Minimum Aw
----------------------------------------------------------------------------------------------------------------
Bacillus cereus................................................. 10-48 deg.C 4.9-9.3 0.95
Campylobacter jejuni............................................ 30-47 deg.C 6.5-7.5 ..............
Clostridium botulinum........................................... 3.3-46 deg.C >4.6 0.94
(Types A,B,E)................................................... .............. .............. ..............
Clostridium perfringens......................................... 15-50 deg.C 5.5-8.0 0.95
Escherichia coli O157:H7........................................ 10-42 deg.C 4.5-9.0 ..............
Listeria monocytogenes.......................................... 2.5-44 deg.C 5.2-9.6 ..............
Salmonella...................................................... 5-46 deg.C .............. 4-9 0.94
Staphylococcus aureus........................................... 6.5-46 deg.C 5.2-9 0.86
Yersinis enterocolitica......................................... 2-45 deg.C 4.6-9.6 ..............
----------------------------------------------------------------------------------------------------------------
Zoonotic agents are biological hazards that cause disease in
animals and can be transmitted and cause disease in humans. The
following lists some zoonotic hazards:
Trichinella spiralis is a nematode parasite whose larval from
encysts primarily in the striated muscle of pigs, horses, rats, bears
and other mammals. Infection in humans results in ``flu-like symptoms''
(diarrhea, fever, stiffness, muscle pain, respiratory distress, etc.)
And heavy infection may lead to death.
Foods associated with illness include: raw and undercooked pork,
bear and equine meat.
Taenia saginata is a human tapeworm whose larval form (Cysticercus
bovis) encysts in the tissues of cattle.
Foods associated with illness include: raw or undercooked beef.
Taenia solium is a human tapeworm whose larval form (Cystricercus
cellulosae) encysts in the tissues of pigs,
[[Page 38906]]
dogs, and humans. Cysts in humans are most common in the subcutaneous
tissues, eye and the brain.
Foods associated with illness include: raw or undercooked pork.
Toxoplasma gondii is a protozoan parasite that encysts in the
tissues of a variety of mammalian hosts including pigs. Human infection
may result in ``flu like'' symptoms in adults, late term abortions in
pregnant women or serious congenial infections in children.
Foods associated with illness include: raw or undercooked pork.
Balantidium coli is a protozoal organism.
Foods associated with illness include: raw, undercooked pork (fecal
contamination)
Cryptosporidium spp.
Foods associated with illness include: inadequately treated water,
raw or undercooked veal or beef.
Chemical Hazards
While biological hazards are of great concern because contaminated
foods can cause widespread illness outbreaks, chemical hazards may also
cause foodborne illnesses, although generally affecting fewer people.
Chemical hazards can originate from four general sources:
(1) Agriculture chemicals: pesticides, herbicides, animal drugs,
fertilizers, etc.
(2) Plant chemicals: cleaners, sanitizers, oils, lubricants,
paints, pesticides, etc.
(3) Naturally-occurring toxicants: products of plant, animal, or
microbial metabolisms such as aflatoxins, etc.
(4) Food chemicals: preservatives, acids, food additives, sulfiting
agents, processing aids, etc.
(5) Environmental contaminants: lead, cadmium, mercury, arsenic,
PCBs.
For many years the Food Safety and Inspection Service has conducted
a National Residue Program to monitor the occurrence of residues from
hazardous chemicals in meat and poultry products. Under a HACCP regime,
frontline responsibility for control of residues from animal drugs or
environmental contaminants will move from the government to the
industry, although the agency will continue to verify that these
controls and preventive measures are effective. Companies that
slaughter livestock and poultry will probably find the FSIS National
Residue Program Plan to be a useful document. The plan contains lists
of compounds that might leave residues in the tissues of animals or
birds, and provides some information on their relative risk through the
rankings in the Compound Evaluation System. It provides information on
which compounds FSIS has included in its annual testing program. It
also provides information on the methods that are used to test for the
compounds. Another FSIS document, the Domestic Residue Data Book,
presents the results of FSIS testing. These data can help a HACCP team
understand the overall hazard presented by various residues, although
each company should gather information about the residue control
performance of its own suppliers.
Another useful reference about hazardous chemicals is the FSIS List
of Proprietary Substances and Nonfood Compounds. This publication lists
substances used in the preparation of product and nonfood compounds
used in the plant environment that have been authorized by FSIS.
Table 2 identifies some additional sources of chemical hazards.
References listed in Section VIII can be used by the HACCP team in
evaluating the potential chemical hazards associated with their product
or process.
Table 2.--Types of Chemical Hazards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Location Hazard
--------------------------------------------------------------------------------------------------------------------------------------------------------
Raw Materials....................... Pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metals, PCBs.
Color additives, inks, indirect additives, packaging materials.
Processing.......................... Direct food additives--preservatives (nitrite), flavor enhancers, color additives.
Indirect food additives--boiler water additives, peeling aids, defoaming agents.
Building and Equipment Maintenance.. Lubricants, paints, coatings.
Sanitation.......................... Pesticides, cleaners, sanitizers.
Storage and Shipping................ All types of chemicals, cross contamination.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical Hazards
Physical hazards include a variety of materials referred to as
extraneous materials or foreign particles or objects. A physical hazard
can be defined as any physical material not normally found in a food
that can cause illness or injury to a person consuming the product.
Physical hazards in finished products can arise from several
sources, such as contaminated raw materials, poorly designed or
maintained facilities and equipment, faulty procedures during
processing, and improper employee training and practices. Table 3
identifies some common physical hazards and their causes or sources.
Table 3.--Types of Physical Hazards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hazard Source or cause
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glass............................... Bottles, jars, light fixtures, utensils, gauge covers, thermometers.
Metal............................... Nuts, bolts, screws, steel wool, wire, meat hooks.
Stones.............................. Raw materials.
Plastics............................ Packaging materials, raw materials.
Bone................................ Raw material, improper plant processing.
Bullet/BB Shot/Needles.............. Animals shot in field, hypodermic needles used for infections.
Jewelry............................. Pens/pencils, buttons, careless employee practices.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 38907]]
Section II
Controls and Critical Limits for Biological, Chemical, and Physical
Hazards
When all significant biological, chemical, and physical hazards are
identified along with their points of occurrence, the next task is to
identify measures to prevent the hazards from compromising the safety
of the finished product.
Preventive measures or controls can be defined as physical,
chemical, or other factors that can be used to remove or limit an
identified hazard. When considering preventive measures or controls, a
limit must be established--this is the criterion that must be met to
ensure safety. For example, proper heat treatment will control some
pathogenic bacteria, and it is thus crucial to know what time/
temperature combinations constitute proper heat treatment for various
products; these time/temperature combinations are the critical limits.
Another example of a preventive measure for a biological hazard is the
chlorination of poultry chiller water to prevent cross contamination of
carcasses with Salmonella.
With identified physical hazards, the most common preventive
measures may be visual examinations of product or the use of a metal
detector. Chemical hazards associated with raw materials may be
controlled through detailed product specifications, letters of
guarantee, or purchase specifications.
Tables 4, 5, and 6 identify preventive measures that may be
considered by the HACCP team. Table 7 gives some examples of regulatory
limits.
Table 4.--Examples of Preventive Measures for Biological Hazards
------------------------------------------------------------------------
Pathogen Preventive measure or control
------------------------------------------------------------------------
Bacillus cereus........................ Proper holding and cooling
temperatures of foods; thermal
processing of shelf-stable
canned food.
Campylobacter jejuni................... Proper pasteurization or
cooking; avoiding cross-
contamination of utensils,
equipment; freezing;
atmospheric packaging.
Clostridium botulinum.................. Thermal processing of shelf-
stable canned food; addition
of nitrite and salt to cured
processed meats; refrigeration
of perishable vacuum packaged
meats; acidification below pH
4.6; reduction of moisture
below water activity of 0.93.
Clostridium perfringens................ Proper holding and cooling
temperatures of foods; proper
cooking times and
temperatures; adequate cooking
and avoidance of cross-
contamination by unsanitary
equipment or infected food
handlers.
Listeria monocytogenes................. Proper heat treatments; rigid
environmental sanitation
program; separation of raw and
ready-to-eat production areas
and product.
Salmonella spp......................... Proper heat treatment;
separation of raw and cooked
product; proper employee
hygiene; fermentation
controls; decreased water
activity; withdrawing feed
from animals before slaughter;
avoiding exterior of hide from
contacting carcass during
skinning; antimicrobial
rinses; scalding procedures;
disinfecting knives.
Staphylococcus aureus.................. Employee hygiene; proper
fermentation and pH control;
proper heat treatment and post-
process product handling
practices; reduced water
activity.
Yersinia enterocolitica................ Proper refrigeration; heat
treatments; control of salt
and acidity; prevention of
cross-contamination.
------------------------------------------------------------------------
Table 5.--Examples of Preventive Measures for Chemical Hazards
------------------------------------------------------------------------
Hazard Preventive measure
------------------------------------------------------------------------
Naturally-Occurring Substances......... Supplier warranty or guarantee;
verification program to test
each supplier's compliance
with the warranty or
guarantee.
Added Hazardous Chemicals.............. Detailed specifications for
each raw material and
ingredient; warranty or letter
of guarantee from the
supplier; visiting suppliers;
requirement that supplier
operates with a HACCP plan;
testing program to verify that
carcasses do not have
residues.
In-Process Chemicals................... Identify and list all direct
and indirect food additives
and color additives; check
that each chemical is
approved; check that each
chemical is properly used;
record the use of any
restricted ingredients.
------------------------------------------------------------------------
Table 6.--Examples of Preventive Measures for Physical Hazards
------------------------------------------------------------------------
Hazard Preventive measure
------------------------------------------------------------------------
Foreign objects in raw materials....... Supplier's HACCP plan; use of
specifications, letters of
guarantee; vendor inspections
and certification; in-line
magnets; screens, traps, and
filters; in-house inspections
of raw materials.
Foreign objects in packaging materials, Supplier's HACCP plan; use of
cleaning compounds, etc. specifications, letters of
guarantee; vendor inspections
and certification; in-house
inspections of materials.
Foreign objects introduced by In-line metal detectors; visual
processing operations or employee product examinations; proper
practices. maintenance of equipment;
frequent equipment
inspections.
------------------------------------------------------------------------
[[Page 38908]]
Table 7.--Some Examples of Regulatory Limits
------------------------------------------------------------------------
Regulatory
Hazard Regulatory limit citation
------------------------------------------------------------------------
biological: Microbial growth due All poultry must be Sec. 381.6
to temperature abuse-Poultry chilled immediately 6
Chilling. after processing to a
temperature of 40
deg.F or less.
chemical: Excess chemicals Chemicals used are Sec. 318.7
contact product. approved for the
intended use and at
appropriate amounts.
chemical: Chemical hazard from Edible products must be Sec. 317.2
packaging materials. packaged in container 4
that will not
adulterate product or
be injurious to health.
Packaging materials
must be covered by a
letter of guaranty.
biological: Trichinae in pork.... Products containing pork Sec. 318.1
muscle tissue must be 0
effectively heated,
refrigerated, or cured
to destroy any possible
live trichinae.
biological: Pathogens in ready to For destruction of Sec. 318.1
eat products. pathogens that may 7
survive a dry heat
process. One of the
time/temperature
combinations for cooked
beef, roast beef, and
cooked corned beef;
e.g., 143 deg.F\61.7
deg.C minimum
temperature at minimum
time of 6 minutes.
physical: Extraneous material Sampled carcasses Sec. 381.7
found on post chill examination observed for 6
of poultry carcasses. conformance with post
chill criteria,
including unidentified
foreign material.
------------------------------------------------------------------------
Section III
Table 8.--Red Meat (Beef) Slaughter Hazards and Controls Use of
Information
This section contains examples of common process steps in beef
slaughter. With each processing step, shown in the first column, you
will find an ``X'' in the next three columns to tell you if there is a
Biological hazard in column 2, a Chemical hazard in column 3, or a
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for your plant's beef slaughter process.
Table 8.--Red Meat Slaughter: Beef
----------------------------------------------------------------------------------------------------------------
Description of biological,
Red meat slaughter-beef: examples of chemical, or physical Controls or preventive
processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Receiving & Holding.................. X --Residues present in edible --Residue certification
tissues above tolerances. presented for live
animal(s).
Skinning............................. X --Micro contamination of --Skinning procedures are
carcass surface due to accomplished without hair
contaminated outside hide or visible fecal
surface--contamination of contamination of the
carcass from floor--cross- carcass.--Careful employee
contamination. practices.--Udder and
puzzle removal are
accomplished without
contamination of edible
product.
Evisceration......................... X --cross-contamination from --Esophagus is tied to
broken viscera. prevent escape of stomach
contents--Bung is dropped
with sanitized knife and
bagged to prevent escape of
feces--Viscera are removed
intact.
Final Wash........................... X --growth of pathogens --Final wash: Temperature:
through insufficient wash. 90-100 deg.F Pressure: 345-
2070 kpa (50-300 psi)--
Steam Pasteurization:
Temperature: 195 deg.F or
greater at surface Dwell
time: 5-15 seconds in
cabinet.
Chilling............................. X --growth of pathogens....... --Surface temperature 40 deg.F as soon as
possible--Carcasses spaced
a minimum of 1 inch apart.
Receiving-Packaging Materials and Non X --contamination from Letters of guarantee on file
Beef Supplies. deletious chemicals present for all packaging materials/
in the packaging materials. non-poultry supplies used
by the establishment.
Storage-Non Beef Supplies............ X --contamination of stored Examine to ensure no visible
packing materials/supplies foreign material on/in non-
from foreign material. poultry supplies or
packaging materials.
----------------------------------------------------------------------------------------------------------------
Section IV
Table 9.--Poultry Slaughter Hazards and Controls
Use of Information
This section contains examples of common process steps in poultry
slaughter. With each processing step, shown in the first column, you
will find an ``X'' in the next three columns to tell you if there is a
Biological hazard in column 2, a Chemical hazard in column 3, or a
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for your plant's poultry slaughter
process.
[[Page 38909]]
Table 9.--Poultry Slaughter
----------------------------------------------------------------------------------------------------------------
Description of biological,
Poultry slaughter: examples of chemical, or physical Controls or preventive
processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Scalding............................. X --contamination from --Fresh water input to
scalding medium. achieve a minimum of 1
quart per bird
--Temperature of the scald
water maintained at
appropriate levels (e.g.,
126 deg.F)
--Maintain counterflow
scalding unit function
--Post scald wash has
sufficient pressure and
volume to cover carcass
with fresh (potable) water
spray
--Overflow volumes are at
required amounts
Offline Procedures................... X --cross contamination from Follow approved offline
intestinal contents/exudate. plant procedures for
handling airsacculitis
salvage and reprocessing
for contamination (e.g., an
airsac salvage program that
transfers the carcasses to
another station where the
thigh, drumstick, wing tip,
and first wing section are
salvaged and washed with
chlorinated water).
Final Wash........................... X --growth of pathogens....... --A final water wash with
appropriate levels of
chlorinated water (e.g. 20-
50 ppm residual chlorine in
the water).
--Sufficient water volume
and pressure for equipment
operation and sufficient
dwell time in the final
washer to remove visible
contamination on internal
and external surfaces of
the carcass.
Chilling-Carcass..................... X --growth of pathogens....... Deep breast muscle
temperature of carcass is
40 deg.F within
the specified time from
slaughter for the class of
poultry.
--Maintain an adequate
chlorine level in the
overflow water of in-line
immersion chillers (e.g.,
20-50 ppm residual chlorine
in the incoming water).
--Maintain proper water flow
rates (input/overflow) for
continuous chillers per
USDA requirements (not less
than \1/2\ gallon of fresh
water per frying chicken
with continuous overflow).
X --contamination from foreign Product entering (prechill)
material. and exiting (postchill) the
chiller system meets the
criteria for defects per
USDA requirements (e.g. the
limits are not exceed for
the number and size of
extraneous materials found
during the postchill
examination-9 CFR Sec.
381.76).
Chilling-Giblet/Neck................. X --growth of pathogens....... --Temperature and fresh
water input sufficient to
meet USDA requirements for
giblets and necks.
--Chlorination of giblet
chiller water at
appropriate levels for
giblets and necks [e.g.,
giblets must be chilled to
40 deg.F within 2 hours
from removal from other
viscera/fresh water intake
not less than 1 gallon per
40 frying chickens
processed-9 CFR Sec.
381.66 (c)(5)].
X --contamination from foreign --Visually free of hazardous
material. foreign material.
--Defects on poultry giblet
and necks meet USDA
requirements (e.g., each
carcass must be observed
for conformance against pre
and post chill criteria,
including unidentified
foreign materials-MPI
Regulations 381.76).
[[Page 38910]]
Cut-Up/Boning/Packaging/ Labeling.... X --growth of pathogens....... Temperature of product does
not exceed 55 deg.F during
further or second
processing.
--Movement of product
through these areas and
into the cooler is timely
and efficient.
--A mid-shift cleanup of the
area(s) is performed if the
room temperature is not
maintained at or below 50
deg.F.
--Packaging/labeling
materials that come into
direct contact with product
are intact.
Receiving-Packaging Materials and Non X --contamination from Letters of guarantee are on
Poultry Supplies. deleterious chemicals file for all packaging
present in the packaging materials/non-poultry
materials. supplies used by the
establishment.
Storage-Non Poultry Supplies......... X --contamination of stored Examine to ensure no visible
packing materials/supplies foreign material on/in non-
from foreign material. poultry supplies or
packaging materials.
----------------------------------------------------------------------------------------------------------------
Section V
Table 10.--Red Meat (Swine) Slaughter Hazards and Controls
Use of Information
This section contains examples of common process steps in swine
slaughter. With each processing step, shown in the first column, you
will find an ``X'' in the next three columns to tell you if there is a
Biological hazard in column 2, a Chemical hazard in column 3, or a
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for your plant's swine slaughter process.
Table 10.--Red Meat Slaughter: Swine
----------------------------------------------------------------------------------------------------------------
Description of biological,
Red meat slaughter-swine: Examples of chemical, or physical Controls or preventive
processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Scalding............................. X X --contamination from Plant time/temperature
scalding medium. limits for scalding (e.g.,
although it may vary with
facilities, a temperature
of 138 to 140 deg.F is
usually satisfactory).
--Carcasses should remain in
scalding tanks long enough
to loosen hair (excessive
time or temperature results
in carcass cooking).
X ... --contamination with --USDA-FDA approved chemical
chemicals.. concentration not to exceed
manufacturer's
recommendations.
Dehairing............................ X ... ... --contamination and growth --Time/temperature
of microorganisms due to determined by plant-
breaking of the skin from specific testing results to
overexposure to the remove visible hair to an
dehairer. acceptable level without
breaking skin.
Evisceration......................... X ... ... --cross contamination from --Remove all viscera intact.
equipment/utensils. --Contaminated equipment
--contamination from will be clean and sanitized
stomach, intestines, and/or before being used again.
bladder contents. --Training program for all
--contamination from employees, to include
employee handling. personal hygiene, product
handling procedures, and
sanitary dressing
procedures.
Trimming............................. X ... ... Stick wound has not been Remove all visible stick-
removed.. wound related defects.
Chilling............................. X ... ... --growth of pathogens....... --Cool surface temperature
to 40 deg. as soon as
possible.
Receiving-Packaging Materials and Non ... X ... --contamination from Letters of guarantee are on
Swine Supplies. deleterious chemicals file for all packaging
present in the packaging materials/non-poultry
materials. supplies used by the
establishment.
Storage-Non Swine Supplies........... ... X --contamination of stored Examine to ensure no visible
packing materials/supplies foreign material on/in non-
from foreign material. poultry supplies or
packaging materials.
----------------------------------------------------------------------------------------------------------------
[[Page 38911]]
Section VI
Table 11.--Ingredient Hazards and Ingredient-Related Hazards
Use of Information
This section contains an alphabetical list of ingredients commonly
used in making meat and poultry products. For each entry you will find
the name of the ingredient in the first column, and an ``X'' in the
next three columns to tell you if there is a Biological hazard in
column 2, Chemical hazard in column 3, or Physical hazard in column 4.
Column 5 describes the hazard(s), and the last column lists some
relevant controls or preventive measures. This table should be used in
conjunction with the list of ingredients developed by your HACCP team
for the products produced by the process under consideration.
The HACCP team may find that a particular ingredient does not
present the hazard identified in these tables. The presence or absence
of a hazard can be influenced by the ingredient source and company.
Also, Ingredient Specifications, provided by the supplier to the
establishment, may give details on the material/ingredient being sold,
including statements that the materials/ingredients are food grade and
are free of harmful components. For example, the ingredient
specifications for dried legumes might state that there will be fewer
than 5 small rocks or stones per 10 pound bag and that no harmful
pesticides were used in the growing process.
Table 11.--Ingredient Hazards
----------------------------------------------------------------------------------------------------------------
Description of biological,
Examples of ingredient B C P chemical, or physical hazard Controls or preventive
for the ingredient measures
----------------------------------------------------------------------------------------------------------------
Acidifiers........................... ... X ... --toxicological effects if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Anticoagulants....................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Antifoaming agents................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/ provider
ingredient specifications.
Antioxidants......................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Batter/Breading...................... X ... X --growth of pathogens due to --Temperature controls for
improper storage and use
handling. --Ingredient specification
--foreign material sheet identifying the
required parameters the
ingredient must meet.
--Where applicable,
ingredients must be
pathogen-free.
Beef (fresh, frozen)................. X ... ... --growth of pathogens due to --Product temperature must
improper storage and be 40 degrees F or less at
handling. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Binders/Extenders.................... ... X X --foreign material.......... --Ingredients purchased
under a Letter of
Guarantee.
--Ingredients purchased
based on producer/ provider
ingredient specifications.
Bleaching agents..................... ... X ... --toxicological effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/ provider
ingredient specifications.
Blood................................ X ... ... --growth of pathogens from --Ingredient specification
improper handling and sheet identifying the
storage. required parameters the
ingredient must meet.
--Where applicable,
ingredients must be
pathogen-free.
--Meet appropriate temp.
Boneless beef........................ X ... X --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--foreign particle --Product must meet
contamination, e.g., metal establishment purchase
fragments or bone. specifications.
--Product must be produced
under a HACCP plan.
--Visual examination of
product for foreign
materials.
[[Page 38912]]
Cooked beef.......................... X ... X --growth of pathogens due to --Receiving temperature of
improper handling and product must be frozen or
storage. refrigerated at 40 degrees
--foreign particle F or below.
contamination, e.g., metal --Product must be received
fragments or bone particles from an approved supplier
in boneless beef. who produces the product
under a HACCP plan.
--Visual examination of
product for foreign
materials upon receipt.
Cooked poultry....................... X ... X --growth of pathogens due to --Receiving temperature of
improper handling and product must be frozen or
storage. refrigerated at 40 degrees
--foreign particle F or below.
contamination, e.g., bone --Product must be received
particles in boneless from an approved supplier
poultry. who produces the product
under a HACCP plan.
--Product must be
organoleptically acceptable
at receipt.
Cooked pork.......................... X ... X --growth of pathogens due to --Receiving temperature of
improper handling and product must be frozen or
storage. refrigerated at 40 degrees
--foreign particle F or below.
contamination, e.g., bone --Product must be received
particles in boneless pork. from an approved supplier
who produces the product
under a HACCP plan.
--Product must be
organoleptically acceptable
at receipt.
Coloring agents (natural)............ ... X ... --Toxicological effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Coloring agents (artificial)......... ... X ... --Toxicological effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Curing agents........................ ... X ... --Toxico logical effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Curing accelerators.................. ... X ... ---toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Dairy products....................... X ... X --growth of pathogens due to --Temperature control.
improper handling and --Ingredient specification
storage. sheet identifying the
--foreign material required parameters the
ingredient must meet.
--Where applicable,
ingredients must be
pathogen-free.
Eggs or egg products................. X ... X --growth of pathogens due to --Temperature control.
improper handling and --Ingredient specification
storage. sheet identifying the
--foreign particle required parameters the
contamination, e.g., shell ingredient must meet.
particles in broken eggs. --Where applicable,
ingredients must be
pathogen-free.
Emulsifying agents................... ... X ... --toxicological effects if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Flavoring agents..................... ... X ... --toxicological effects if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Fruits............................... ... X X --contamination from --Ingredient specification
agricultural chemicals. sheet identifying the
--foreign material required parameters the
ingredient must meet.
Honey................................ X ... X --contamination from --Ingredient specification
inherent microorganisms. sheet identifying the
--foreign particle required parameters the
contamination, e.g., dirt, ingredient must meet.
insect parts.
Legumes (dry)........................ ... ... X --foreign particle --Ingredient specification
contamination, e.g., rocks. sheet identifying the
required parameters the
ingredient must meet.
[[Page 38913]]
Mechanically deboned product......... X ... X --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--foreign particle --Product must meet
contamination, e.g., bone establishment purchase
particles. specifications.
--Product must be produced
under a HACCP plan.
Mold inhibitors...................... ... X ... --toxicological effect if --Ingredient specification
improper amounts used. sheet identifying the
required parameters the
ingredient must meet.
Mushrooms............................ X X X --contamination from --Ingredient specification
inherent microorganisms. sheet identifying the
--contamination from required parameters the
agricultural chemicals. ingredient must meet.
--foreign material --Where applicable,
ingredients must be
pathogen-free.
Nuts................................. X X X --contamination from --Ingredient specification
inherent microorganisms. sheet identifying the
--contamination from required parameters the
agricultural chemicals. ingredient must meet.
--foreign particle
contamination, e.g., broken
shells.
Packaging materials.................. ... ... X --toxicological effects..... --Use only FDA approved
packaging materials.
-- Each lot of packaging
material must be
accompanied by a Letter of
Guarantee in which the
manufacturer attests to
compliance with FDA
requirements.
Phosphates........................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Poultry (fresh, frozen).............. X ... ... --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Pork (fresh, frozen)................. X ... ... --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Proteolytic enzymes--Aspergillus ... ... ... --toxicological effects if --Ingredients purchased
oryzae, Aspergillus, Flavusoryzae limits exceeded. under a Letter of
group, Bromelin, Ficin, Papain. Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Partially defatted products.......... X ... X --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--foreign particle --Product must meet
contamination, e.g., metal, establishment purchase
plastic. specifications.
--Product must be produced
under a HACCP plan.
Seafood (fresh, frozen).............. X X ... --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--environmental --Product must meet
contamination. establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Spices/herbs--Sterilized, X ... ... --contamination from --Ingredient specification
Unsterilized. microorganisms inherent to sheet identifying the
the ingredient. required parameters the
--contamination from ingredient must meet.
agricultural chemicals.
--foreign material
Sweeteners--Saccharin, Citric acid, ... ... ... --toxicological effects if --Ingredients purchased
Malic acid, Monoisopropyl citrate, limits exceeded. under a Letter of
Phosphoric acid, Monoglyceride Guarantee.
citrate. --Ingredients purchased
based on producer/provider
ingredient specifications.
[[Page 38914]]
Tenderizing agents................... ... X ... --toxicological effects if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Variety meats........................ X ... ... --growth of pathogens due to --Product temperature must
improper handling, storage, be 40 degrees F or less at
or cleaning. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Vegetables........................... X X X --growth of pathogens due to --Ingredient specification
improper handling and sheet identifying the
storage. required parameters the
--contamination from ingredient must meet.
agricultural chemicals.
--foreign material
----------------------------------------------------------------------------------------------------------------
Section VII
Table 12.--Processing Hazards and Controls
Use of Information
This section contains a list of processing hazards and controls
commonly used in making meat and poultry products. They are listed in
alphabetical order. For each processing step, shown in the 1st column,
you will find an ``X'' in the next three columns to tell you if there
is a Biological hazard in column 2, Chemical hazard in column 3, or
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for the products produced during the
process under consideration.
Table 12.--Processing Step Hazards
----------------------------------------------------------------------------------------------------------------
Description of biological,
chemical, or physical Controls or preventive
Processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Acidifying (also see Pickling, X ... ... --survival of pathogens due --Shelf-stable non-heat
Brining). to final pH>4.6. treated acidified product
must obtain a pH of 4.6 or
lower.
Aging (Meats)........................ X ... ... --growth/survival of --The temperature of the
pathogens from aging room will not exceed
inappropriate storage 40 degrees Fahrenheit.
temperatures and humidity --Product temperature does
(inadequate product water not exceed 40 degrees
activity (aw)). Fahrenheit throughout the
--growth of pathogens due to aging process.
rise in the pH due to --The aging process will not
development of surface exceed seven days.
molds.
Boning............................... X ... ... --contamination by pathogens --Careful employee practices
in product accumulations to make sure that there is
(e.g., cutting boards, no contamination of the
conveyor belts, utensils product.
and other equipment). --Equipment and utensils are
--cross-contamination of washed and sanitized
product by equipment/ immediately when
utensils contaminated with contaminated and each time
pathogens when cutting the employee leaves the
through a non-apparent working station.
lesion (e.g., abscesses). --All hot water sanitizers
are maintained at 180
degrees Fahrenheit.
--Processing room
temperature is maintained
at 50 degrees Fahrenheit,
or a midshift cleanup is
performed within five hours
after operations begin.
--contamination from bones, --A boneless beef re-
cartilage/extraneous inspection procedure will
material. be established using
specifications outlined by
FSIS.
Cooling.............................. X ... ... --growth of pathogens due to Cooked product will be
improper temperatures. cooled according to
--germination of spore- established procedures.
forming pathogens due to
slow chilling (e.g., C.
perfringens).
Cooking.............................. X ... ... --survival of pathogens due --Time/Temperature
to improper procedures. combinations are adequate
to destroy the pathogens of
concern.
[[Page 38915]]
Drying (Meat)........................ X ... ... --bacterial growth due to --A water activity will be
inadequate control over specified that in
time, temperature and conjunction with other
humidity. barriers will inhibit
growth of pathogenic
microorganisms (e.g., for
shelf stable sausage Aw of
0.91 and a pH of 4.6).
Filling.............................. X ... ... --recontamination by --Product will be protected
pathogens in product from contamination during
accumulations. the filling process, and
--growth of pathogens due to product temperature/ time
temperature abuse. will be maintained at or
below the maximum
determined to inhibit
growth of pathogenic
microorganisms.
... X ... --contamination from --No lubricants or other
lubricants. chemical contaminants will
be allowed in or on the
product.
Formulation.......................... X ... ... --contamination by employee --Careful employee practices
handling. used at all times to make
--incorrect formulation sure that there is no
--contamination through contamination of product.
damaged packages. --Ingredient packages will
be clean and intact.
--Ingredients will be added
to product according to
requirements outlined 9CR
Sec. 318.7.
... X ... --excessive addition of --Restricted ingredients
restricted ingredients/ will be added to product
additives could be toxic to according to requirements
the consumer. outlined in the 9CFR Sec.
317.8.
Freezing (Meats)..................... X ... ... --survival of parasites due --Rapid cooling and
to improper time/ freezing.
temperature application.
--growth of pathogens due to
temperature abuse.
Grinding............................. X ... ... --contamination by employee --Careful employee practices
handling. to make sure that there is
--recontamination by no contamination of
pathogens in product product.
accumulations. --Product will not be
allowed to accumulate at
the end of the grinder.
--The temperature of the
grinding room will be
maintained at 50 degrees
Fahrenheit.
Grinding............................. ... X ... --contamination from --Food grade lubricants will
lubricants. be used on areas of the
machinery where a potential
for product contamination
exists.
... ... X --contamination from --All boneless product will
extraneous material. be re-inspected before
being loaded into the
grinder.
Handling and Inspecting of Empty X X X --recontamination through --Packaging materials and
Containers and Packaging Materials. damaged or soiled empty containers will be
containers/packaging protected from
material. contamination during their
storage and handling.
--No materials or containers
that appear to be
contaminated with hazardous
foreign material will be
used.
Mechanical Separating................ X ... ... --growth of pathogens....... --Product holding and
cooling requirements
outlined in 9CFR 318.18
will be followed.
X --contamination from bone, --The finished product will
cartilage fragments. meet the standards outlined
--contamination from in 9CFR 319.5 for bone
extraneous material. particles and calcium.
Packaging (also see Modified X X X --contamination from --Closure and/or machine
Atmosphere Packaging, Vacuum packaging material. specifications sufficient
Packaging Seaming, Sealing). --contamination through to ensure adequate barrier
damaged containers. formation.
... ... X ............................ --No detectable foreign
material will be allowed in
or on the product or
immediate product
containers.
Peeling.............................. X ... ... --contamination by pathogens --Careful employee practices
in product accumulations. to make sure that there is
--contamination from no contamination of
employee handling. product.
--Product will not be
allowed to accumulate in/on
peeling equipment.
... ... X --contamination from harmful --Peeling equipment will be
extraneous material. maintained in a proper
operating condition. No
foreign material in the
finished product.
[[Page 38916]]
Receiving............................ X ... ... --contamination through --Product must be received
damaged containers. in sound containers and at
--growth of pathogens due to temperatures appropriate
inappropriate storage for the type of product.
conditions (temperature,
humidity).
--growth of pathogens due to
temperature abuse.
--contamination from
receiving equipment (pumps,
hoses).
... X ... --cross-contamination from --Product must be received
non-food chemicals. in sound containers and be
accompanied by a letter of
guarantee from the supplier
if such letter is not on
file.
... X ... --contamination from --Product must be received
hazardous extraneous in sound containers and be
material (wood, nails from accompanied by a letter of
pallets, plastic pieces). guarantee from the supplier
if such letter is not on
file.
Retorting............................ X ... ... --inadequate application of --A thermal process specific
scheduled process. to the product, container
type and size, and
retorting system must be in
use. The initial product
temperature and any
critical factors specified
for the thermal process
must also be controlled.
Specified retort come up
procedures will be
followed.
Reworking............................ X ... ... --contamination by employee --Careful employee practices
handling. to make sure that there is
--contamination by pathogens no contamination of
in product accumulations. product.
--Room temperature of
storage coolers will not
exceed 40 degrees
Fahrenheit.
... ... X --contamination foreign --Careful employee practices
material. to make sure that there is
no contamination of
product.
Shipping............................. X ... ... --growth due to improper --Product will not be
temperatures. shipped unless it is 40
degrees Fahrenheit or less.
--Product will not be loaded
into transport vehicles if
the trailer temperature
exceeds 40 degrees
Fahrenheit.
... ... X --contamination from --All product packages will
hazardous extraneous be intact before shipping.
material through damaged --All transport vehicles
packages. will be cleaned after each
use and before loading of
product.
Thawing.............................. X ... ... --growth of pathogens due to --Thawing Room temperature
improper temperatures. will not exceed 50 degrees
Fahrenheit.
----------------------------------------------------------------------------------------------------------------
Section VIII
REFERENCES
Hazard Analysis Critical Control Point Systems
Agriculture Canada. Food Safety Enhancement Program--Implementation
Manual. Nepean, Ontario, Canada.
HACCP: The Hazard Analysis and Critical Control Point System in the
Meat and Poultry Industry. 1994. American Meat Institute Foundation.
Washington, D.C.
International Commission on Microbiological Specification for Foods.
1989. ``Microorganisms in Foods 4. Application of hazard analysis
and critical control point (HACCP) system to ensure microbiological
safety and quality.'' Blackwell Scientific Publications, Boston.
National Advisory Committee on Microbiological Criteria for Foods
(NACMCF).
March 20, 1992--Hazard Analysis and Critical Control Point System.
Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for Foods
(NACMCF). June 1993--Report on Generic HACCP for Raw Beef. Food
Micr. 10: 449-488.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis
Critical Control Point Programs.'' A Workshop Manual. The Food
Processors Institute. Washington, D.C.
Tompkin, R.B. 1990. The Use of HACCP in the Production of Meat and
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Foodborne Illnesses
Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks in
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Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks, 5-
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[[Page 38917]]
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Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth, I.K.
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Appendix E--FSIS Sample Collection Guidelines and Procedure for
Isolation and Identification of Salmonella from Raw Meat and Poultry
Products
Introduction
This sampling protocol has been prepared to support the Pathogen
Reduction/HACCP Regulation. FSIS will be conducting a Salmonella
testing program in support of this regulation. The regulation does not
require establishments to conduct their own testing for Salmonella.
However, for those who choose to conduct their own Salmonella testing
program, the protocol outlined in this document provides detailed
instruction for sample collection and analysis that are the same as
those used in the FSIS Salmonella testing program for raw meat and
poultry products.
This protocol incorporates the use of a non-destructive sampling
technique for sample collection of raw beef and swine carcasses. These
techniques have been evaluated by the Agricultural Research Service and
have been designed to give comparable results to the FSIS Nationwide
Microbiological Baseline Data Collection Programs' excised tissue
samples. We are continuing to improve the sponging techniques and
welcome comments. This technique will be closely monitored during the
first year of prevalence phase Salmonella testing. Carcass sampling for
broiler and turkey carcasses remain the nondestructive whole bird rinse
which was used in the Baseline Programs. Ground product sampling
involves collecting approximately \1/2\ pound of the product.
The analytical methods section of this protocol details the
cultural procedures currently in use by FSIS/USDA for the examination
of raw meat and poultry products for Salmonella. Any screening method
under consideration for Salmonella testing must meet or exceed the
following performance characteristics: sensitivity = 97%,
specificity 96%, false-negative rate = 3%, false-positive
rate 4%.
Guidelines for Sample Collectors/Microbiologists
Pre-Sampling Preparation
Prior to collecting samples, the individual designated for sample
collection should compile a written establishment-specific sample
collection protocol for microbiological analysis. This protocol should
include a check list for tasks to be performed prior to sample
collection, materials needed for sample collection, random selection
procedures, where the samples will be analyzed (on-site versus off-
site), and other information that will aid the sample collector.
Sampling supplies, such as sterile gloves, sterile sampling solutions,
hand soap, sanitizing solution, etc., as well as specific materials
needed for sampling different carcass types (i.e., specimen sponges in
bags, if sampling cattle or swine carcasses), will need to be
assembled.
For cattle and hog carcass sampling, a template will be needed to
mark off the area to sample (Figure 1). The template can be made of
metal or aluminum foil, brown paper, etc. From a sheet larger than the
area to be sampled, cut out a 10 cm (3.94 inches) x 10 cm square for
sampling cattle or a 6 cm x 10 cm rectangle for swine carcass sampling.
If a reusable metal template is used, it will need to be sanitized with
an approved sanitizing solution (e.g. hypochlorite (bleach) solution or
alcohol). However, the template needs to be dry before placing it on
the carcass. Aluminum foil or paper templates can be used once and
discarded. The foil for the template should be stored in a manner to
prevent contamination. Since the area enclosed by the template will be
sampled, take care not to touch this area with anything other than the
sampling sponge. Using dirty or contaminated material may lead to
erroneous results. If an autoclave is available, paper or aluminum foil
templates can be wrapped in autoclavable paper and sterilized.
The sterile sampling solution, Buffered Peptone Water (BPW), can be
stored at room temperature. However, at least one day prior to sample
collection, check solutions for absence of cloudiness and/or turbidity
and place the number of containers of sampling solution (BPW) that will
be needed for the next day's sampling in the refrigerator. DO NOT use
solutions that are cloudy, turbid, or contain particulate matter.
To obtain the most accurate results, samples should be analyzed as
soon after collection as possible. However, if samples must be
transported to an off-site laboratory, the samples need to be
[[Page 38918]]
maintained at refrigeration temperatures until transport, then shipped
refrigerated via an overnight delivery service to the laboratory
performing the analysis. Samples analyzed off-site must be picked up by
the overnight courier the SAME calendar day the sample is collected.
The sample must arrive at the laboratory no later than the day after
the sample is collected. Samples shipped to an outside laboratory must
be analyzed no later than the day after collection. The following
section gives information on shipping containers and transporting
samples to off-site facilities.
Shipping Containers and Coolant Packs
It is important that samples fit easily into the shipping so that
the sample bags do not break.
Correct use of the refrigerant gel-ice packs and proper packing of
the shipping container are necessary so that samples arrive at the
laboratory at an acceptable temperature. Frozen samples or samples
which are too warm are not considered valid and must not be analyzed.
Some bacteria may be damaged by temperatures that are too cold.
Temperatures that are too warm can allow bacteria to reproduce.
Maintaining samples at improper temperatures may cause inaccurate
sample results.
The sample should be kept refrigerated, NOT FROZEN, in the shipping
container prior to pickup by the courier. The shipping container,
itself, should not be used as a refrigerator. However, multiple samples
(if needed) for that day may be stored in the open shipping container
in the cooler or refrigerator.
Random Selection of Carcasses or Ground Product for Sampling
Samples are to be taken randomly. There are different methods of
selecting the specific carcass for sampling that could be used but all
require the use of random numbers. Methods could include: using random
number tables, drawing cards, using calculator- or computer-generated
random numbers, etc. When selecting the random numbers, use the
method(s) currently in use at the establishment for other sampling
programs, if other programs are currently underway.
The carcass or ground product for sampling must be selected at
random from all eligible carcasses. If multiple lines exist, randomly
select the line for sample collection for that interval. Repeat the
random selection process for the next sampling interval. Each line
should have an equal chance of being selected at each sampling
interval.
Cattle Carcass Selection
The half-carcasses eligible for sampling should be selected from
those in the cooler 12 or more hours after slaughter. Both the
``leading'' and ``trailing'' sides of a carcass should have an equal
chance of being selected. NOTE: If more than one shift is operating at
the plant, the sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that carcasses chilled for
12 or more hours will be on hand. Then randomly select a time for
collecting samples. If samples are shipped off-site, then take into
account that the delivery service may have limitations on pickup times.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the half-carcass. This site may be
located at the transfer chain, grading chain, or a rail that contains
carcasses that have been chilled 12 hours or more.
Selection of HALF-CARCASS: At the random time selected, identify a
half-carcass (selected by your random number method) from the
predetermined point along the chain (selected cooler site) and then
count back five (5) half-carcasses and select the next half-carcass
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection.
Swine Carcass Selection
The carcasses eligible for sampling should be selected from those
in the cooler 12 or more hours after slaughter. Every carcass should
have an equal chance of being selected.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that carcasses chilled for
12 or more hours will be on hand. Then randomly select a time for
collecting samples. If samples are shipped off-site, then take into
account that the delivery service may have limitations on pickup times.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the carcass. This site may be located at
the transfer chain, or a rail that contains carcasses that have been
chilled 12 hours or more. If there are multiple sites of the same kind,
select one at random.
Selection of CARCASS: At the random time selected, identify a
carcass (selected by your random number method) from the predetermined
point along the chain and then count back five (5) carcasses and select
the next carcass for sampling. The reason for counting back five
carcasses is to avoid any possible bias during selection.
Poultry Carcass Selection
The poultry carcasses will be selected at random after chilling, at
the end of the drip line or last readily accessible point prior to
packing/cut-up. A WHOLE carcass is required, that is, one that has not
been trimmed.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that chilled carcasses will
be on hand, then randomly select a time for collecting samples. If
samples are shipped off-site, then take into account that the delivery
service may have limitations on pickup times.
Selection of CHILLER: If more than one chiller system is in
operation at the time of sample collection, the chill tank from which
the sample is selected must be randomly selected.
Selection of POULTRY CARCASS: At the random time, identify a
carcass (selected by your random number method) from the predetermined
point, and then count back five (5) carcasses and select the next
carcass for sampling. Exception: If the fifth carcass is not a WHOLE
(untrimmed) bird, count back an additional five carcasses for sample
selection. Remember: Each carcass must have an equal chance of being
selected. The reason for counting back five carcasses is to avoid any
possible bias during selection.
Raw Ground Product Selection (Beef, Pork, Chicken, Turkey)
Raw ground product samples will be randomly selected and collected
after the grinding process and, if possible before any addition of
spices or seasonings, but prior to final packaging.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that raw ground product will
be produced, then randomly select a time for collecting samples. Take
into account that the overnight delivery service may have limitations
on pickup times, for determining sample collection time.
Selection of GRINDER: If more than one grinder is in operation at
the time of sample collection, the grinder from which the sample is
selected must be randomly selected.
[[Page 38919]]
Aseptic Techniques/Sampling
Extraneous organisms from the environment, hands, clothing, sample
containers, sampling devices, etc., may lead to erroneous analytical
results. Stringent requirements for microbiological analysis are
necessary, therefore, use of aseptic sampling techniques and clean
sanitized equipment and supplies are of utmost importance. The
following information gives general techniques for aseptic techniques
that are routinely used during sample collection for microbiological
analysis.
There should be an area designated for preparing samples, etc. A
stainless steel, wheeled cart or table would be useful during sampling.
A small tote or caddy could be could be easily transported to the
location of sampling and used for carrying supplies, supporting sample
bags when adding sterile solutions to sample bags, etc.
Sterile gloves should be used for collecting samples. The only
items which may contact the external surface of the glove are the
exposed sample being collected and/or the sterile sample utensil
(specimen sponge). Keep in mind that the outside surfaces of the sample
container are not sterile. Do not handle the inside surface of the
sterile sample containers. Do not touch anything else. The following
procedure for putting on sterile gloves can be followed when collecting
samples:
(a) Peel open the package of sterile gloves from the top without
contaminating (touching, breathing on, contacting, etc.) the exterior
of the gloves.
(b) Remove a glove by grasping it from the wrist-side opening inner
surface which is folded. Avoid any contact with the outer surface of
the glove. Insert the washed and sanitized hand into the glove, taking
care not to puncture the glove or touch the outside surface of the
glove.
(c) Next, follow the same procedure for the hand you will use to
physically handle the sample, using care not to contaminate the outer
surface of the glove.
(d) If at any time you are concerned that a glove may be
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
Prior to collecting samples, review steps for sample collection,
random selection procedure, etc.
At least one or more days prior to sample collection, check
sampling solution (BPW) for cloudiness/turbidity and refrigerate if not
cloudy or turbid. If shipping samples to off-site facility, place
coolant packs in freezer then pre-chill open shipping in cooler/
refrigerator.
On the day of sampling, gather all sample collection bags, sterile
gloves, sanitizer, hand soap, sterile solutions for sampling, and
specific materials listed under the Materials section of the sample
collection section for the type of carcass to be sampled.
Label the sample bags before starting sampling procedure. Use
permanent ink. If you are using paper labels, it is important that the
label be applied to the bag at normal room temperature; it will not
stick if applied in the cooler.
Outer clothing (frocks, gloves, head gear, etc.) worn in other
areas of the plant should be removed before entering the sampling area
or preparing to collect samples. Replace outer clothing removed earlier
with clean garments (i.e. laboratory coat) that have not been directly
exposed to areas of the plant outside of the sampling area.
Sanitize the sample work area surfaces by wiping with a clean
disposable cloth or paper towel dipped in a freshly prepared 500 ppm
sodium hypochlorite solution (0.05% sodium hypochlorite) or other
approved sanitizer which provides an equivalent available chlorine
concentration. The sample work area surfaces must be free of standing
liquid before sample supplies and/or product containers are placed on
them.
Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands
using disposable paper towels.
Specific Sample Collection Procedures
Raw Ground Product
Materials
1. 2 sterile ziplock-type or stomacher bags or equivalent.
2. Sterile gloves.
3. Plastic cable-tie-wrap or thick rubber band for securing bag.
Collection
Ensure that all supplies are on hand and readily available. Use the
predetermined random selection procedure to select sample. Samples of
raw ground product will be collected after the grinding process, and,
if possible, before the addition of any spices or seasonings, but prior
to final packaging.
1. Put on sterile gloves.
2. Aseptically collect approximately \1/2\ pound of ground product,
if possible, before the addition of any spices or seasonings, but just
prior to final packaging. (Sample will be about the size of an orange.)
Use the sterile sampling bag, taking care not to contaminate the inside
of the bag with your gloved hand.
3. Close the bag tightly by twisting the top and securing it with
the plastic cable-tie-wrap or rubber band or securely closing the
ziplock-type bag.
4. Place bagged sample inside a second bag and close the outer bag
tightly.
5. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for analysis.
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Cattle Surface Sample Collection Procedure
Materials
1. Sterile specimen sponge in sterile Whirl-Pak bag or
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile ziplock-type or stomacher bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
A sterile, moistened sampling sponge (which usually come pre-
packaged in a sterile bag) will be used to sample all three sites on
the swine carcass (ham, belly, and jowls--see Figure 3). It is
important to swab the sampling areas in the order of least to most
contaminated to avoid spreading any contamination on the carcass.
Therefore, swab sampling areas in the sequence indicated in this
protocol. Use predetermined random selection procedures for selecting
carcass to be sampled. Remember: samples will be collected from
carcasses in the cooler 12 hours or more after slaughter.
Nondestructive surface sampling will be conducted as follows:
1. Ensure that all bags have been pre-labeled and all supplies are
on hand, including the sampling template. (An assistant may be helpful
during the sampling process.)
2. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the rump sample area (Figure 2) is within easy
reach from the ladder.
3. IF a reusable template is used, have the assistant immerse the
sampling
[[Page 38920]]
template in a sanitizing solution for at least 1-2 minutes. Just prior
to taking the first sample on the carcass, have the assistant put on a
pair of gloves (taking care not to contaminate the outer surface of the
glove with fingers) and retrieve the sampling template from the
sanitizing solution. Shake excess solution from utensil, then protect
the portion of the template that will contact the carcass from
contamination.
4. Locate the flank, rump, and brisket sampling sites using
illustrations and directions in Figure 2 (cattle carcass sampling
locations).
5. To hydrate the sponge, open the sponge bag. Remove cap from
sterile BPW bottle, being careful not to touch the bottle opening.
Carefully pour the contents of the sterile BPW bottle (10 ml) into the
sponge bag to moisten the sponge.
6. Close the top of the bag. Use hand pressure from the outside of
the bag and carefully massage the sponge until it is FULLY HYDRATED
(moistened).
7. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag orienting one narrow end of the sponge
up toward the opening of the bag. Do NOT open the bag or touch the
sponge with your fingers.
8. Open the bag containing the sponge, being careful not to touch
the inner surface of the bag with your fingers. The wire closure at the
top of the bag should keep the bag open. Set bag aside.
9. Put on sterile gloves.
10. Carefully remove the moistened sponge from the bag with your
sampling hand. Take care to avoid touching the surfaces of the sampling
sponge.
11. With the other hand, retrieve the template by the outer edge
taking care to avoid contaminating the inner edges of the sampling area
of the template.
12. Locate the flank sampling area (Figure 2) and place template
over this
location.
13. Hold the template in place with one gloved hand. Take care not
to contaminate the enclosed sampling area with your hands.
14. With the other hand, wipe the sponge over the entire enclosed
area (10 cm x 10 cm) for the sample for a total of approximately 10
times in the vertical and 10 times in the horizontal directions. The
pressure for swabbing would be as if you were removing dried blood from
the carcass. However, the pressure should not be too hard as to crumble
or destroy the sponge. (Note: The template may need to be ``rolled''
from side to side during swabbing since the surface of the carcass is
not flat. This ensures that the 100 cm\2\ area is enclosed while
swabbing.)
15. Repeat steps 13-15 for the brisket area, using the SAME side or
surface of the sponge used to swab the flank sampling area.
16. After swabbing the brisket area, transfer the template to the
same hand holding the sponge. Do not contaminate the inner edges of the
sampling area of the template.
17. Climb the ladder or platform, holding onto the handrail with
the hand NOT used to perform swabbing. Once at a convenient and safe
height for sampling the rump, transfer template back to ``climbing''
hand (hand used to hold onto the rail while climbing the ladder),
taking care not to contaminate the inner edges of the sampling area of
the template. Avoid contaminating your sampling hand.
18. Repeat steps 13-15 for the rump area, using the ``clean''
surface or side (the side that was NOT previously used to swab the
flank/brisket areas).
19. After swabbing the rump area, carefully place the sponge back
in the sample bag, taking care not to touch the outside of the sponge
to the outside of the sample bag.
20. While holding the handrail, climb down from the ladder.
21. Expel excess air and fold the top edge of the bag containing
the sponge 3 or 4 times to close. Secure the bag by folding the
attached wire tie back against the bag.
22. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Swine Surface Sample Collection Procedure
Materials
1. Sterile specimen sponge in sterile Whirl-Pak bag or
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile Ziplock-type or stomacher bag
4. Template for a 100 cm2 sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. A
sterile, moistened sampling sponge (which usually come pre-packaged in
a sterile bag) will be used to sample all three sites on the swine
carcass (ham, belly, and jowls--see Figure 3). It is important to swab
the sampling areas in the order of least to most contaminated to avoid
spreading any contamination on the carcass. Therefore, swab sampling
areas in the sequence indicated in this protocol. Use predetermined
random selection procedures for selecting carcass to be sampled.
Remember: samples will be collected from carcasses in the cooler 12
hours or more after slaughter.
Nondestructive surface sampling will be conducted as follows:
1. Ensure that all supplies are on hand. (An assistant may be
helpful during the sampling process.)
2. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the ham sample area (Figure 3) is within easy reach
from the ladder.
3. Immerse the sampling template in a sanitizing solution for at
least 1-2 minutes. Just prior to swabbing the first sampling site on
the carcass (step 1), retrieve the sampling template from the
hypochlorite sanitizing solution. Shake excess solution from utensil,
then protect the portion of the template (especially the inner edges of
the sampling area) that will contact the carcass from contamination.
4. Locate the ``belly'', ham, and jowl sampling sites using
illustrations and directions in Figure 3 (swine carcass sampling
locations).
5. Open the sponge bag by holding the bag at one corner by the wire
closure (which is usually colored yellow) then tear off the clear,
perforated strip at the top of the bag. (Do not remove or tear off the
wire closures). Next, pull apart the two small white tabs on either
side of the bag to open the mouth of the bag.
6. Remove cap from sterile BPW tube, being careful not to touch the
bottle opening. Carefully pour the entire contents of the BPW bottle
(10 ml) into the sponge bag to moisten the sponge.
7. Close the top of the bag by pressing the wire closures together.
Use hand pressure from the outside of the bag and carefully massage the
sponge until it is FULLY HYDRATED (moistened).
8. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag positioning one narrow end of the
sponge up toward the opening of the bag. The whole sponge should still
be inside the bag.
9. Open the top of the bag containing the sponge, being careful not
to touch the inner surface of the bag with your fingers. The wire
closure at the top of
[[Page 38921]]
the bag should keep the bag open. Set bag aside.
10. Put on a pair of sterile gloves.
11. Carefully remove the moistened sponge from the bag with your
sampling hand. Take care not to touch the surfaces of the sampling
sponge intended for sampling with sterile glove.
12. With the other hand, retrieve the template by the outer edge,
taking care not to contaminate the inner edges of the sampling area of
the template.
13. Locate the ``belly'' sampling area (Figure 2) and place the
template over this location.
14. Hold the template in place with one gloved hand (Remember, only
the sponge should touch the sampling area. Take care not to contaminate
this area with your hands).
15. With the other hand, wipe the sponge over the entire enclosed
area (10 cm x 10 cm) for the sample for a total of approximately 10
times in the vertical and 10 times in the horizontal directions. The
pressure for swabbing would be as if you were removing dried blood from
the carcass. However, the pressure should not be too hard as to crumble
or destroy the sponge. (Note: The template may need to be ``rolled''
from side to side during swabbing since the surface of the carcass is
not flat. This ensures that the 100 cm2 area is enclosed while
swabbing.)
16. After swabbing the ``belly'' area, transfer the template to the
same hand that is holding the sponge. Do not contaminate the inner
edges of the sampling area of the template.
17. Climb the ladder or platform, holding onto the handrail with
the hand not used for sampling. Once at a convenient and safe height
for sampling the ham, transfer template back to the ``climbing'' hand
(hand used to hold onto the rail while climbing the ladder), taking
care not to contaminate the inner edges of the template. Avoid
contaminating your sampling hand.
18. Repeat steps 13-15 for the ham sampling area, using the SAME
surface of the sponge used to swab the ``belly'' area.
19. After swabbing the ham area, carefully place the template back
to the same hand that is holding the sponge. Do not contaminate the
inner edges of the sampling area of the template.
20. While holding the handrail with the hand not used for sampling,
climb down from the ladder.
21. Transfer the template back to the ``climbing'' hand (hand used
to hold onto the rail while descending the ladder), taking care not to
contaminate the inner edges of the template.
22. Repeat steps 13-15 for the the jowl area, using the ``clean''
surface or side (the side that was NOT previously used to swab the
``belly''/ham areas).
23. After swabbing the jowl area, carefully place the sponge back
into the sponge bag. Do not touch the surface of the sponge to the
outside of the sponge bag.
24. Press wire closures on the sponge bag together, expel the
excess air, then fold over the top of the bag 3 or 4 times. Close the
bag with attached wire by bending the wire tie back against the bag to
secure it.
25. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section).
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Whole Chicken Carcass Rinse Sampling Procedure
Materials
1. 2 Sterile 3500 ml stomacher-type bags or equivalent
2. 400 ml sterile Buffered Peptone Water (BPW)
3. Plastic cable-tie wraps or thick rubber bands or equivalent
4. Sterile gloves
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Ensure
all sampling supplies are present and have been properly labeled. Use
predetermined random selection procedure to select a carcass. Birds
will be collected after the chiller, at the end of the drip line as
follows:
1. Gather all supplies for sampling. An assistant may be helpful
during the sampling process when pouring the rinse solution (BPW) into
the bag containing the carcass.
2. Put on sterile gloves. Open a stomacher-type 3500 bag without
touching the sterile interior of the bag. Rubbing the top edges between
the thumb and forefinger will cause the opening to gap for easy
opening.
3. With one hand, push up through the bottom of the sampling bag to
form a `glove' over one hand with which to grab the bird, while using
your other hand to pull the bag back over the hand that will grab the
bird. This should be done aseptically without touching the exposed
interior of the bag.
4. Using the hand with the bag reversed over it, pick up the bird
by the legs (hocks) through the stomacher bag. (The bag functions as a
``glove'' for grabbing the bird's legs.) Take care not to contaminate
the exposed interior of the bag. Allow any excess fluid to drain before
reversing the bag back over the bird. (Alternately, have an assistant
hold open the bag. Using your gloved hand, pick up the bird by the
legs, allow any fluid to drain, and place the bird vent side up into
the sampling bag.)
5. Rest the bottom of the bag on a flat surface. While still
holding the top of the bag slightly open, add the 400 ml of sterile BPW
to the sterile plastic bag. (Alternately, with the aid of an assistant
holding the bag open, add the 400 ml of sterile BPW to the bag, pouring
the solution into the carcass cavity.)
6. Close the bag and while securely holding the bag, rinse bird
inside and out using a rocking motion for 30 shakes (approximately one
minute). This is done by holding the bird through the bottom of the bag
with one hand and the closed top of the bag with the other hand. Hold
the bird securely and rock it in an arcing motion, alternating the
weight of the bird from one hand to the other (motion like drawing an
invisible rainbow or arch), assuring that all surfaces (interior and
exterior of the carcass) are rinsed.
7. Put the bird in the bag on a flat surface. Open the bag.
8. With a gloved hand, remove the carcass from the bag. Since the
carcass was rinsed with a sterile solution, it should be returned to
the chill tank. Be sure not to touch the interior of the bag with your
gloved hand.
9. Twist the top of the bag several times (about 4 or 5 turns).
Fold the twisted portion of the bag to form a loop. Secure the twisted
loop with the supplied plastic tie-wrap. The tie-wrap should be very
tight so that the rinse fluid will not spill out. Place the sample bag
into another bag and secure the opening of the outer bag. [Alternately,
at least 30 ml of the rinse fluid can be poured into a sterile, leak-
proof sampling container and the container then can be placed in a
sampling bag for transport to the lab. NOTE: It is important to send at
least the minimum volume of rinse fluid, since 30 ml of rinse fluid
will be used for sample analysis. The solution remaining after
decanting the 30 ml can be poured down the drain]
10. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis.
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
[[Page 38922]]
Turkey Carcass Rinse Sampling Procedure
Materials
1. 1 large sterile 3500 ml stomacher-type or ziplock-type bags or
equivalent, at least 8'' x 24''
2. 600 ml sterile, Buffered Peptone Water (BPW)
3. Plastic cable-tie wraps or thick rubber bands or equivalent
4. Sterile gloves
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Ensure
that all supplies are on hand, labeled, and readily available. An
assistant will be needed to hold the bag for collecting the bird. Use
the predetermined random selection procedure to select the turkey
carcass to be sampled. The randomly selected birds will be collected
after the chiller, at the end of the drip line as follows:
1. Have an assistant open the large stomacher-type bag (18'' x
24''). (Rubbing the top edges of the stomacher-type bag between the
thumb and index finger will cause the opening to gap.) The assistant
should be ready to receive the turkey carcass.
2. Put on sterile gloves.
3. Remove the selected turkey from the drip line by grasping it by
the legs and allowing any fluid to drain from the cavity.
4. Place the turkey carcass, vent side up, into a sterile
Stomacher-type 3500 bag (or equivalent). Large turkeys should be placed
in a plain, clear polypropylene autoclave bag (ca. 24'' x 30-36'').
Only the carcass should come in contact with the inside of the bag.
5. While still supporting the carcass with one hand on the bottom
of the bag, have the assistant open the bag with the other hand.
Alternately, the assistant can rest the bottom of the bag on a
sanitized table and while still supporting the carcass, open the bag
with the other hand.
6. Add the 600 ml of sterile BPW to the sterile plastic bag,
pouring the solution into the carcass cavity of the BPW over the
exterior of the carcass. Close the bag.
7. Manipulate the loose neck skin on the carcass through the bag
and position it over the neck bone area to act as a cushion and prevent
puncturing of the bag. The assistant will need to support the carcass
with one hand on the bottom of the bag. Close bag.
8. Squeeze air from the bag and close top. Take the bag from the
assistant. Close the bag and while securely holding the bag, rinse bird
inside and out using a rocking motion for 30 shakes (approximately one
minute). This is done by holding the carcass through the bag with one
hand and the closed top of the bag with the other hand. Holding the
bird securely with both hands, rock in an arcing motion alternating the
weight of the bird from one hand to the other (motion like drawing an
invisible rainbow or arch), assuring that all surfaces (interior and
exterior of the carcass) are rinsed.
9. Hand the bag back to the assistant.
10. With a gloved hand, remove the carcass from the bag first
letting any excess fluid drain back into the bag. Since the carcass was
rinsed with a sterile solution, it should returned to the chill tank.
Be sure not to touch the interior of the bag with your gloved hand.
11. Expel excess air, taking care not to expel any rinse fluid.
Twist the top of the bag several times (about 4 or 5 turns). Fold the
twisted portion of the bag to form a loop. Secure the twisted loop with
the supplied plastic tie-wrap. The tie-wrap should be very tight so
that the rinse fluid will not spill out.
12. Place the sample bag into another bag and secure the opening of
the outer bag. [Alternately, no less than 30 ml of the rinse fluid can
be poured into a sterile, leak-proof sampling container and placed in a
sampling bag for transport to the lab. Thirty ml of rinse fluid will be
used for sample analysis. The solution remaining after decanting the 30
ml can be poured down the drain]
13. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis. (See
Analytical Methods section.)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
It is recommended that samples be analyzed on-site (not in the
plant itself, but in a suitable laboratory). Those samples analyzed on-
site must be analyzed as soon after collection as possible. If no on-
site facilities are available, the samples must be shipped the same
calendar day as collected, to an outside laboratory. The samples must
be analyzed the day after collection.
1. Prechill shipping container by placing the open shipping
container in the refrigerator at least the day before sampling.
2. Place the appropriately-labeled double-bagged sample in the
prechilled shipper in an upright position to prevent spillage.
Newspaper may be used for cushioning the sample and holding it in the
upright position. Ensure that the sample is maintained at refrigeration
temperature to prevent multiplication of any microorganisms present and
to provide the most accurate results.
3. Place a corrugated cardboard pad on top of the sample. Next,
place the frozen gel pack(s) on top of the corrugated pad to prevent
direct contact of frozen gel packs with the sample. Use sufficient
frozen coolant to keep the sample refrigerated during shipment to the
designated laboratory. Insert a foam plug and press it down to minimize
shipper head space.
4. Ship sample (via overnight delivery or courier) to the assigned
laboratory.
Analytical Methods
Equipment, Reagents, and Media Equipment
1. Sterile scalpels, scissors, forceps, knives, spatulas, spoons, ruler
or template, pipettes, petri dishes, test tubes
2. Sterile Stomacher 3500 bags (or equivalent) or plain, clear
polypropylene autoclave bags (ca. 24'' x 30-36'')
3. Incubator, 36 1 deg.C
4. Incubator/Water bath, 42 0.5 deg.C
5. A mechanical homogenization device. A Stomacher, used with sterile
plastic bags, is acceptable. Some laboratories prefer to use a sterile
Osterizer-type blender with sterilized cutting assemblies and adapters
for use with sterile Mason jars.
6. Water bath, 48-50 deg.C
7. Glass slides, glass plate marked off in one-inch squares or
agglutination ring slides
8. Balance, 2000 gram capacity, sensitivity of 0.1 gram
9. Inoculating needles and loops
10. Vortex mixer
11. Sterile sampling sponge and sponge bag
Reagents
1. Iodine solution for TT broth (Hajna)
2. Buffered Peptone Water (BPW) diluent
3. Methyl red reagent
4. O'Meara's V-P reagent, modified
5. Kovac's reagent
6. Ferric chloride, 10% aqueous solution
7. Sterile mineral oil
8. Saline, 0.85%
9. Saline, 0.85% with 0.6% formalin
10. Salmonella polyvalent O antiserum
11. Salmonella polyvalent H antiserum
12. Salmonella individual O grouping sera for groups A-I
[[Page 38923]]
Media
1. Buffered peptone water (BPW)
2. Tetrathionate broth (TT-Hajna)
3. Rappaport-Vassiliadis (RV) broth (4)--Merck Chemical Co., Cat. #7700
or equivalent
4. Brilliant green sulfa agar (BGS; contains 0.1% sodium sulfapyridine)
5. Double modified lysine iron agar (DMLIA; 2)
6. Triple sugar iron agar (TSI)
7. Lysine iron agar (LIA)
8. MR-VP Medium
9. Tryptone broth
10. Simmons citrate agar
11. Phenol red tartrate agar
12. Motility Medium
13. Christensen's urea agar
14. Carbohydrate fermentation media with Andrade's indicator
15. Decarboxylase test media (Moeller)
16. Malonate broth
17. KCN broth
18. Phenylalanine agar
19. Nutrient gelatin
20. Trypticase soy broth
21. Tryptose broth
Analytical Procedures
Sample Preparation for Analysis
The diverse nature of the samples which may require analysis (e.g.,
ground product versus a poultry carcass rinse sample) requires separate
preparation procedures for each sample type.
Raw Ground Product Sample Preparation
a. Use a sterile spoon or spatula to take portions of product from
several areas of the sample to prepare a 25 g composite sample in a
sterile plastic stomacher-type bag or blender jar. Use of a stomacher
filter bag may facilitate pipetting after pre-enrichment.
b. Add 225 ml BPW. Homogenize for two minutes in a Stomacher or
blender.
Beef or Pork Carcass Sponge Sample Preparation
a. Add 50 ml of BPW to the sample bag containing the sponge to
bring the total volume to 50 ml. Mix well.
Whole Chicken Carcass Rinse-Fluid Sample Preparation
a. Remove 30 ml of carcass-rinse fluid and place it in a sterile
plastic bag or other sterile container.
b. Add 30 ml of BPW to the sample. Mix well.
Turkey Carcass Rinse-Fluid Sample Preparation
a. Remove 30 ml of carcass-rinse fluid and place it in a sterile
plastic bag or other sterile container.
b. Add 30 ml of BPW to the sample. Mix well.
Detection Procedure
Sample/BPW suspensions prepared as directed in Sample preparation
for analysis section (above) are the starting point for this step in
the protocol. From this point on, sample suspensions of various types
(e.g., whole bird rinse sample vs. raw ground product) can be treated
in the same manner.
Note: If using a screening test, follow manufacturer's
instruction for enrichment procedures. If an alternate enrichment
scheme is to be used, verification of the effectiveness of this
alternate enrichment protocol with the screening test should be
received from the manufacturer of the screening test or by in-
laboratory testing.
1. Incubate sample/BPW suspension at 36 1 deg.C for
20-24 hours.
2. a. Transfer 0.5 ml of the BPW sample pre-enrichment culture into
10 ml TT broth.
b. Transfer 0.1 ml of the BPW sample pre-enrichment culture into 10
ml RV broth.
3. a. Incubate the TT enrichment culture at 42
0.5 deg.C for 22-24 hours.
b. Incubate the RV enrichment culture at 42 0.5 deg.C
for 22-24 hours.
4. Streak each enrichment culture onto both DMLIA and BGS agar
plates. Do not subdivide plates for streaking multiple samples; streak
the entire agar plate with a single sample enrichment.
5. Incubate plates at 36 1 deg.C.
6. Examine plates after 22-24 hours of incubation. Reincubate
negative plates and reexamine them the following day.
7. Select and confirm suspect colonies as described in the sections
for Isolation procedure through Biochemical testing procedures (below).
Isolation Procedure
1. Pick typical well-isolated colonies.
a. BGS. Select colonies that are pink and opaque with a smooth
appearance and an entire edge surrounded by a red color in the medium.
On very crowded plates, look for colonies that appear tan against a
green background.
b. DMLIA. Select purple colonies with or without black centers.
Since salmonellae typically decarboxylate lysine and ferment neither
lactose nor sucrose, the color of the medium reverts to purple.
2. Select three suspect colonies from each plate. Pick only from
the surface and center of the colony. Avoid touching the agar because
these selective media may suppress growth of organisms which are viable
but not visible; such ``sleeper'' organisms can be picked up from the
agar surface and carried forward onto media used for confirmation
tests. If a plate is crowded and there are no well-isolated colonies
available, restreak from this plate directly onto fresh selective agar
plates.
Initial Isolate Screening Procedure
1. Inoculate TSI and LIA slants consecutively with a single pick
from a colony by stabbing the butts and streaking the slants in one
operation. If screw-cap tubes are used, the caps must be loosened
before incubation. Incubate at 36 1 deg.C for
242 hours.
2. Examine TSI and LIA slants as sets. Note the colors of butts and
slants, blackening of the media and presence of gas as indicated by gas
pockets or cracking of the agar. Note also the appearance of the growth
on the slants along the line of streak. Discard sets that show
``swarming'' from the original site of inoculation. Discard sets that
show a reddish slant in LIA. Isolates giving typical Salmonella spp.
reactions should be confirmed by serological tests. Examine isolates
which are suggestive, but not typical of Salmonella spp. by a
combination of biochemical and serological procedures. Confirm by
biochemical tests ONLY those isolates that appear typical of
salmonellae, but do not react serologically. Refer to the following
chart for assistance in making these determinations.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triple sugar iron agar Lysine iron agar Polyvalent sera
---------------------------------------------------------------------------------------------------------------------- Disposition
Butt Slant H 2S Butt H2S O H
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y.............. R + P + + + Salmonella spp.
Y.............. R + P + + - B. & M. T.
Y.............. R - P - ............... ............... B. & M. T.
Y.............. R - Y - + + B. & M. T.\1\
Y.............. R - Y - - ............... Discard.
Y.............. R + Y ............... ............... Discard.
Y.............. Y - Y/P - ............... ............... Discard.
[[Page 38924]]
Y.............. Y + P + ............... ............... B. & M. T.\2\
NC............. NC ............... ............... ............... ............... ............... Discard.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y = Yellow; R = Red; P = Purple; B. & M. T. = Biochemical and motility tests; NC = No change in color from uninoculated medium.
\1\ Salmonella choleraesuis (rarely found in swine in U.S.).
\2\ Salmonella arizonae.
Serological Tests
All isolates giving TSI and LIA reactions which could be considered
suggestive of Salmonella should be tested serologically. If the TSI and
LIA reactions, together with the serological reactions, are indicative
of Salmonella, confirmation may cease at this point. If, however,
atypical TSI or LIA results and/or negative serological tests are
encountered, biochemical testing is mandatory (see Biochemical testing
procedure, below).
1. O Agglutination Tests
At a minimum, isolates should be tested with polyvalent O antiserum
reactive with serogroups A through I. Following a positive reaction
with polyvalent O antiserum, it is necessary to type the isolate using
individual Salmonella antisera for O groups A through I. Testing for O
groups A through I should encompass the majority of the Salmonella
serotypes commonly recovered from meat and poultry products.
Occasionally, however, an isolate which is typical of Salmonella
(biochemically and Poly H serologically) but non-reactive with antisera
to groups A through I will be recovered; such an isolate should be
reported as ``Salmonella non A-I'' or ``Salmonella O group beyond I''.
Follow the manufacturer's instructions enclosed with the antisera.
Use growth from either the TSI or LIA slant. Test the isolate first
using polyvalent O antiserum. Do not read agglutination tests with a
hand lens. If there is agglutination with the saline control alone
(autoagglutination), identify such an isolate by biochemical reactions.
If the saline control does not agglutinate and the polyvalent serum
does, identify the individual O group using the individual Salmonella O
grouping antisera for groups A through I. Record positive results and
proceed to H agglutination tests.
2. H Agglutination Tests
Inoculate Trypticase soy broth or Tryptose broth. Incubate at 36
1 deg.C overnight or until growth has an approximate
density of three on McFarland's scale. Add an equal amount of saline
containing 0.6% formalin and let set one hour. Remove one ml to each of
two 13 x 100 mm test tubes. To one of the tubes, add Salmonella
polyvalent H serum in an amount indicated by the serum titer or
according to the manufacturer's instructions. The other tube serves as
an autoagglutination control. Incubate both tubes at 48-50 deg.C in a
water bath for up to one hour. Record presence or absence of
agglutination. Alternatively, any other poly H agglutination test may
be used as long as it gives results equivalent to the conventional tube
agglutination procedure described above.
Biochemical Testing Procedures
Biochemical confirmation is only necessary with those isolates
giving atypical TSI or LIA results and/or negative serological tests.
Do the minimum number of tests needed to establish that an isolate can
be discarded or that it is a member of the genus Salmonella. Exhaustive
testing of any isolate from a sample that has already yielded a
typical, easily identifiable Salmonella is unnecessary.
If further testing is necessary, inoculate the following media
first: Tryptone broth, MR-VP medium, Simmons citrate agar,
Christensen's urea agar, motility test medium, phenol red tartrate
agar, and glucose, lactose, sucrose, salicin and dulcitol fermentation
broths. Incubate at 36 1 deg.C and record reactions the
following day. Test Tryptone broth with Kovac's reagent for indole
production in 24 hours and, if negative, again in 48 hours. Do not
perform the MR-VP test until 48 hours have elapsed. If results are
ambiguous, repeat MR test after five days of incubation. Hold negative
carbohydrate fermentation tests for 14 days.
Refer to ``Edwards and Ewing's Identification of
Enterobacteriaceae'', 4th Edition (3), for biochemical reactions of
Enterobacteriaceae and for fermentation media and test procedures.
Discard all isolates that give positive urea or VP reactions.
Discard any isolate that has the following combination of
characteristics: produces gas in glucose, produces indole but not
H2S, is MR positive, VP negative and citrate negative; such
organisms are E. coli regardless of ability to ferment lactose in 48
hours.
Inoculate additional biochemical tests as necessary to eliminate
other Enterobacteriaceae. Refer to Edwards and Ewing for details.
Eliminate Providencia spp. by a positive phenylalanine reaction.
Eliminate Hafnia alvei on the basis of the following biochemical
pattern: indole negative; MR negative, and VP and citrate positive
based on four days of incubation at 25 deg.C; fermentation of
arabinose and rhamnose; failure to ferment adonitol, inositol,
sorbitol, and raffinose.
Alternatively, any other biochemical test system may be used as
long as it gives results equivalent to the conventional tests.
Quality Control Procedures
It is recommended that a minimum of three method controls be
analyzed whenever meat or poultry products are being examined for the
presence of salmonellae. These controls should include a S. typhimurium
(H2S positive), S. senftenberg (H2S negative), and an
uninoculated media control. The inoculum level for the positive
controls should approximate 30-300 CFU per container of enrichment
medium. Inoculate positive controls at the end of each day's run.
Incubate the three controls along with the samples, and analyze them in
the same manner as the samples. Confirm at least one isolate recovered
from each positive control sample.
Storage of Isolates
Do not store isolates on TSI agar because this tends to cause
roughness of O antigens. For short-term (2-3 months) storage, inoculate
a nutrient agar slant, incubate at 36 1 deg.C overnight,
and then store at 4-8 deg.C.
For long-term storage of isolates, subculture Salmonella isolates
by stabbing nutrient agar (0.75% agar). Incubate at 36 1
deg.C overnight, and then seal with hot paraffin-soaked corks.
Household wax is better than embedding paraffin because it stays
relatively soft at room temperature making the corks easy to remove.
Store isolates in the dark at room
[[Page 38925]]
temperature. Such isolates will remain viable for several years.
Store ``working'' Salmonella stock cultures on nutrient agar
slants. Transfer stocks monthly, incubate overnight at 36
1 deg.C, and then store them at 4-8 deg.C.
References
1. AOAC International. 1995. Official Methods of Analysis of
AOAC International. P.A. Cunniff, ed. 16th Edition. Gaithersburg,
MD.
2. Bailey, J. S., J. Y. Chiu, N.A. Cox, and R.W. Johnston. 1988.
Improved selective procedure for detection of salmonellae from
poultry and sausage products. J. Food Protect. 51(5):391-396.
3. Ewing, W. H. 1986. ``Edwards and Ewing's Identification of
Enterobacteriaceae'', 4th Edition. Elsevier Science Publishing Co.,
Inc., New York, NY.
4. Vassiliadis, P. 1983. The Rappaport-Vassiliadis (RV)
enrichment medium for the isolation of salmonellas: An overview. J.
Appl. Bacteriol. 54:69-76.
BILLING CODE 3410-DM-P
[[Page 38926]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.018
[[Page 38927]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.019
[[Page 38928]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.020
BILLING CODE 3410-DM-C
[[Page 38929]]
Appendix F--Guidelines for Escherichia coli Testing for Process Control
Verification in Cattle and Swine Slaughter Establishments
Introduction
Under the Pathogen Reduction/HACCP Regulation, all slaughter
establishments will be required to test carcasses for generic E. coli
as a tool to verify process control. This document outlines the
sampling and microbial testing that should be followed to meet this
requirement. It also gives guidance to interpreting your results. This
document is a supplement to the Regulation, but not a substitute for
it. Further in-depth details of the program may be found in the
Regulation. Please provide these guidelines to your company
microbiologist or testing laboratory in order to help you meet the
regulatory requirements for generic E. coli testing.
Guidelines for Sample Collectors/Microbiologists
Background
This sampling protocol has been prepared to support the Pathogen
Reduction/HACCP Regulation. This protocol incorporates the use of a
nondestructive sampling technique for sample collection from raw beef
and swine carcasses. These techniques have been evaluated by the
Agricultural Research Service and have been designed to give comparable
results to the FSIS Nationwide Microbiological Baseline Data Collection
Programs' excised tissue samples. We are continuing to improve the
sponging techniques and welcome comments. This technique will also be
used in the FSIS Salmonella testing programs and will be closely
monitored during the first year of prevalence phase testing.
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control across the
nation. It is imperative that all like establishments adhere to the
same sampling and analysis requirements detailed here, without
deviation. These sampling and analytical procedures may be directly
written into your establishment's individual HACCP plan.
Cattle and swine carcasses must be sampled at the end of the
slaughter process in the cooler. These sample collection locations are
the same as those in the FSIS baseline studies, making samples taken
here comparable to the nationwide baseline performance criteria.
Pre-sampling Preparation
Sample collection will be carried out by the individual designated
in the establishment's written protocol for microbiological sampling.
This protocol should include a check list of tasks to be performed
prior to sample collection, materials needed for sample collection,
random selection procedures, where the samples will be analyzed (on-
site versus off-site), and other information that will aid the sample
collector. As stated previously, this guideline can be a part of the
plant's sample collection guidelines, but plant specific details and
procedures will need to be included. Sampling supplies, such as sterile
gloves, sterile sampling solutions, hand soap, sanitizing solution,
etc., as well as specific materials needed for sampling different
carcass types (i.e., specimen sponges in bags and template for sampling
cattle or swine carcasses), will need to be assembled prior to
beginning sample collection.
For cattle and swine carcass sampling, a template will be needed to
mark off the area to sample. The template can be made of metal or
aluminum foil, brown paper, flexible plastic, etc. Some disposable
templates may come sterilized and individually prepackaged. To make a
reusable template, cut out a 10 centimeters (cm) x 10 cm (3.94 inches x
3.94 inches) square from a sheet larger than the area to be sampled.
(See Figure 1). If a reusable template is used, it will need to be
sanitized with an approved sanitizing solution [e.g., hypochlorite
(bleach) solution or alcohol]. However, the template needs to be dry
before placing it on the carcass. Aluminum foil or paper templates can
be used once and discarded. The foil for the template should be stored
in a manner to prevent contamination. Since the area enclosed by the
template will be sampled, take care not to touch this area with
anything other than the sampling sponge. Using dirty or contaminated
material may lead to erroneous results. If an autoclave is available,
paper or aluminum foil templates can be wrapped in autoclavable paper
and sterilized.
Sterile sampling solutions, Butterfield's phosphate diluent (BPD),
can be stored at room temperature. However, at least on the day prior
to sample collection, check solutions for cloudiness. DO NOT use
solutions that are cloudy, turbid or contain particulate matter. Place
the number of containers of sampling solution (BPD) that will be needed
for the next day's sampling in the refrigerator.
To obtain the most accurate results, samples should be analyzed as
soon after collection as possible. However, if samples must be
transported to an off-site laboratory, the samples need to be
maintained at refrigeration temperatures until transport, then shipped
refrigerated via an overnight delivery service to the laboratory
performing the analysis. Samples analyzed off-site must be picked up by
the overnight courier the SAME calendar day the sample is collected.
The sample must arrive at the laboratory the day after the sample is
collected. Samples shipped to an outside laboratory must be analyzed no
later than the day after collection. The following section gives
information on shipping containers and transporting samples to off-site
facilities.
Shipping Containers and Coolant Packs
It is important that samples fit easily into the shipping
containers so that the sample bags do not break. Correct use of the
refrigerant gel-ice packs and proper packing of the shipping container
are necessary so that samples arrive at the laboratory at an acceptable
temperature. Frozen samples or samples which are too warm are not
considered valid and must not be analyzed. Some bacteria may be damaged
by temperatures that are too cold, while temperatures that are too warm
can allow bacteria to reproduce. Maintaining samples at improper
temperatures may cause inaccurate sample results. The sample should be
kept refrigerated, NOT FROZEN, in the shipping container prior to
pickup by the courier service. The shipping container, itself, should
not be used as a refrigerator. However, multiple samples (if needed)
for that day may be stored in the open shipping container in the cooler
or refrigerator.
Sampling frequency
Sampling frequency for E. coli testing is determined by production
volume. The required minimum testing frequencies for all but very low
production volume establishments are shown in Table 1 by slaughter
species.
Table 1.--E. coli Testing Frequencies a
------------------------------------------------------------------------
Cattle.................................... 1 test per 300 carcasses.
Swine..................................... 1 test per 1,000 carcasses.
------------------------------------------------------------------------
a Note: These testing frequencies do not apply to very low volume
establishments. See Table 2.
Very Low Volume Establishments
Some establishments may be classified as very low volume
establishments. The maximum yearly
[[Page 38930]]
slaughter volumes for very low volume establishments are described in
Table 2.
Table 2.--Maximum Yearly Livestock Slaughter Volumes for Very Low Volume
Establishments
------------------------------------------------------------------------
Criteria (yearly slaughter
Slaughter species volume)
------------------------------------------------------------------------
Cattle................................ Not more than 6,000 head.
Swine................................. Not more than 20,000 head.
Cattle and Swine...................... Not more than 20,000 total, with
not more than 6,000 cattle.
------------------------------------------------------------------------
Establishments with very low volumes are to sample the predominant
species at an initial rate of once per week until at least 13 test
results have been obtained. Once the initial criteria have been met for
very low volume establishments (see APPLYING PERFORMANCE CRITERIA TO
TEST RESULTS), the establishment will repeat the same sampling regime
once per year, in the 3 month period of June through August, or
whenever a change is made in the slaughter process or personnel.
Random Selection of Carcasses
Samples are to be taken randomly at the required frequency (See
section on Sampling Frequency). For example, given the frequency of
testing for cattle is 1 (one) test per every 300 cattle slaughtered,
then if a plant slaughters 150 head of cattle an hour, 1 (one) sample
will be taken every 2 hours.
Different methods of selecting the specific carcass for sampling
could be used, but all require the use of random numbers. Methods could
include: using random number tables, using calculator- or computer-
generated random numbers, drawing cards, etc. When selecting the random
numbers, use the method(s) currently in use at the establishment for
other sampling programs, if other programs are currently underway.
The carcass for sampling must be selected at random from all
eligible carcasses. If multiple lines exist, randomly select the line
for sample collection for that interval. Repeat the random selection
process for the next sampling interval. Each line should have an equal
chance of being selected at each sampling interval.
Cattle Carcass Selection
The half-carcasses eligible for sampling should be selected from
those in the cooler 12 or more hours after slaughter. Both the
``leading'' and ``trailing'' sides of a carcass should have an equal
chance of being selected within the designated time frame (based on the
sampling frequency for the plant). NOTE: If more than one shift is
operating at the plant, the sample can be taken on any shift, provided
the following requirements are met:
Selection of TIME: Select the time, based on the appropriate
sampling frequency, for collecting the sample.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the half-carcass. This site may be
located at the transfer chain, grading chain, or a rail that contains
carcasses that have been chilled 12 hours or more. If there are
multiple sites of the same kind, select one at random.
Selection of HALF-CARCASS: Based on the sampling frequency for the
plant, identify a half-carcass (selected by your random number method)
from the predetermined point along the chain (cooler site) and then
count back five (5) half-carcasses and select the next half-carcass
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection. (See Sampling
Frequency section to determine the rate of sampling.)
Swine Carcass Selection
The carcasses eligible for sampling should be selected from those
in the cooler 12 or more hours after slaughter. Every carcass should
have an equal chance of being selected within the designated time frame
(based on the sampling frequency for the plant). NOTE: If more than one
shift is operating at the plant, the sample can be taken on any shift,
provided the following requirements are met:
Selection of TIME: Select the time, based on the appropriate
sampling frequency, for collecting the sample.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the carcass. This site may be located at
the transfer chain, grading chain, or a rail that contains carcasses
that have been chilled 12 hours or more. If there are multiple sites of
the same kind, select one at random.
Selection of CARCASS: Based on the sampling frequency for the
plant, identify a whole carcass from the predetermined point along the
chain and then count back five (5) carcasses and select the next
carcass for sampling. The reason for counting back five carcasses is to
avoid any possible bias during selection. (See Sampling Frequency
section to determine the rate of sampling.)
Aseptic Techniques/Sampling
Extraneous organisms from the environment, hands, clothing, sample
containers, sampling devices, etc., may lead to erroneous analytical
results. More stringent requirements for microbiological analysis are
necessary, therefore, use of aseptic sampling techniques and clean,
sanitized equipment and supplies are of utmost importance.
There should be an area designated for preparing sampling supplies,
etc. A stainless steel, wheeled cart or table would be useful during
sampling. A small tote or caddy could be moved to the location of
sampling and could be used for carrying supplies, supporting sample
bags when adding sterile solutions to sample bags, etc.
Sterile gloves should be used for collecting samples. The only
items which may contact the external surface of the glove are the
exposed sample being collected and/or the sterile sample utensil
(specimen sponge). Keep in mind that the outside surfaces of the sample
container are not sterile. Do not handle the inside surface of the
sterile sample containers. Do not touch anything else. The following
procedure for putting on sterile gloves can be followed when collecting
samples:
(a) Peel open the package of sterile gloves from the top without
contaminating (touching, breathing on, contacting, etc.) the exterior
of the gloves.
(b) Remove a glove by holding it from the wrist-side opening inner
surface. Avoid any contact with the outer surface of the glove. Insert
the washed and sanitized hand into the glove, taking care not to
puncture the glove.
(c) Taking care not to contaminate the exterior surface of the
glove, repeat the above step for the hand you will use to physically
handle the sample.
(d) If at any time you are concerned that a glove may be
Preparation for Sample Collection
Prior to collecting samples, review appropriate sampling steps,
random selection procedures, and other information that will aid in
sample collection.
On the day prior to sample collection, after checking for
cloudiness/turbidity, place the number of BPD containers that will be
needed for the next day's sampling in the refrigerator/cooler. If
samples are to be shipped to an off-site facility, pre-chill shipping
container and refrigerator packs.
On the day of sampling, gather all sample collection bags, sterile
gloves, sanitizer, hand soap, sterile solutions for
[[Page 38931]]
sampling, and specific materials listed under the Materials section of
the sample collection section for the type of carcass to be sampled.
Ensure that all sampling supplies are on hand and readily available
before beginning sample collection.
Label the sample bags before starting the sampling procedure. Use
permanent ink. If you are using paper labels, it is important that the
label be applied to the bag at normal room temperature; it will not
stick if applied in the cooler.
Outer clothing (frocks, gloves, head gear, etc.) worn in other
areas of the plant should be removed before entering the sampling area
or preparing to collect samples. Replace outer clothing removed earlier
with clean garments (i.e., laboratory coat) that have not been directly
exposed to areas of the plant outside of the sampling area.
Sanitize the sample work area surfaces by wiping with a clean
disposable cloth or paper towel dipped in a freshly prepared 500 ppm
(parts per million) sodium hypochlorite solution (0.05% sodium
hypochlorite) or other approved sanitizer which provides an equivalent
available chlorine concentration. The sample work area surfaces must be
free of standing liquid before sample supplies and/or product
containers are placed on them.
Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands
using disposable paper towels.
Specific Sample Collection Procedures
Cattle Sample Collection Procedure
Materials
1. Sterile specimen sponge in sterile Whirl-pack-type bag or
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher bag
4. Template for 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use
predetermined random selection procedures for selecting the half-
carcass to be sampled. Remember, samples will be collected from half-
carcasses in the cooler 12 hours or more after slaughter.
A sampling sponge (which usually comes dehydrated and prepackaged
in a sterile bag) will be used to sample all three sites on the carcass
(flank, brisket, and rump--see Figure 2). It is important to swab the
areas in the order of least to most contamination in order to avoid
spreading any contamination.
Therefore, swab the areas in the sequence indicated in this
sampling protocol. Nondestructive surface sampling will be conducted as
follows:
1. Ensure that all bags have been pre-labeled and all supplies are
on hand, including the sampling template. (An assistant may be helpful
during the sampling process.)
2. IF a reusable template is used, immerse the sampling template in
an approved sanitizing solution for at least 1-2 minutes. Just prior to
swabbing the first sample site on the carcass (step 13), retrieve the
sampling template from the sanitizing solution. Shake excess solution
from the utensil, then protect the portion of the template that will
contact the carcass from contamination.
3. Locate the flank, brisket, and rump sampling sites using
illustrations and directions in Figure 2 (cattle carcass sampling
locations).
4. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the rump sample area (Figure 2) is within easy
reach from the ladder.
5. While holding the sponge bag at the top corner by the wire
closure, tear off the clear, perforated strip at the top of the bag.
6. Remove the cap from sterile BPD bottle, being careful not to
touch the bottle opening.
7. Carefully pour about half the contents of the sterile BPD bottle
(approximately 10 ml) into the sponge bag to moisten the sponge.
8. Close the top of the bag by pressing the wire closures together.
Use hand pressure from the outside of the bag and carefully massage the
sponge until it is FULLY HYDRATED (moistened).
9. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag orienting one narrow end of the sponge
up toward the opening of the bag. Do NOT open the bag or touch the
sponge with your fingers. While holding the bag, gently squeeze any
excess fluid from the sponge using hand pressure from the outside. The
whole sponge should still be in the bag.
10. Open the bag containing the sponge, being careful not to touch
the inner surface of the bag with your fingers. The wire closure at the
top of the bag should keep the bag open. Set bag aside.
11. Put on a pair of sterile gloves.
12. Carefully remove the moistened sponge from the bag with the
thumb and fingers (index and middle) of your sampling hand.
13. With the other hand, retrieve the template by the outer edge,
taking care not to contaminate the inner edges of the sampling area of
the template.
14. Locate the flank sampling area (Figure 2). Place the template
over this location.
15. Hold the template in place with one gloved hand (Remember, only
the sponge should touch the sampling area. Take care not to contaminate
this area with your hands)
16. With the other hand, wipe the sponge over the enclosed sampling
area (10 cm x 10 cm) for a total of approximately 10 times in the
vertical and 10 times in the horizontal directions. The pressure for
swabbing would be as if you were removing dried blood from the carcass.
However, the pressure should not be too hard as to crumble or destroy
the sponge. (Note: The template may need to be ``rolled'' from side to
side during swabbing since the surface of the carcass is not flat. This
ensures that the 100 cm\2\ area is enclosed while swabbing.)
17. Repeat steps 14-16 for the brisket area, using the SAME side or
surface of the sponge used to swab the flank area.
18. After swabbing the brisket area, transfer the template to the
same hand holding the sponge. Do not contaminate the sponge or inner
edges of the sampling area of the template.
19. Climb the ladder or platform, holding onto the handrail with
the hand used to hold the template. Once at a convenient and safe
height for sampling the rump, transfer template back to ``climbing''
hand (hand used to hold onto the rail while climbing the ladder),
taking care not to contaminate the inner edges of the template.
20. Repeat steps 14-16 for the rump area, using the ``clean''
surface or side (the side that was NOT previously used to swab the
flank/brisket areas) of the sponge.
21. After swabbing the rump area, carefully place the sponge back
in the sponge sample bag, taking care not to touch the sponge to the
outside of the sample bag.
22. While holding the handrail, climb down from the ladder.
23. Add the additional BPD (about 15 ml) to the sample bag to bring
the total volume to approximately 25 ml.
24. Expel excess air from the bag containing the sponge and fold
down the top edge of the bag 3 or 4 times to close. Secure the bag by
folding the attached wire tie back against the bag.
[[Page 38932]]
Place closed sponge bag into second bag and close the second bag
securely.
25. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Swine surface sample collection procedure:
Materials
1. Sterile specimen sponge in sterile Whirl-Pak-type bag or
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher-type bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use
predetermined random selection procedures for selecting carcass to be
sampled. Remember: samples will be collected from carcasses in the
cooler 12 hours or more after slaughter. A sampling sponge (which
usually comes dehydrated and prepackaged in a sterile bag) will be used
to sample all three sites on the swine carcass (belly, ham, and jowl--
see Figure 3). It is important to swab the areas in the order of least
to most contamination in order to avoid spreading any contamination.
Therefore, swab the areas in the sequence indicated in this sampling
protocol. Nondestructive surface sampling will be conducted as follows:
1. Ensure that all supplies are on hand. (An assistant may be
helpful during the sampling process.)
2. If a reusable template is used, immerse the sampling template in
a sanitizing solution for at least 1-2 minutes. Just prior to swabbing
the first sample site on the swine carcass (step 12), retrieve the
sampling template from the sanitizing solution. Shake excess solution
from the utensil, then protect the portion of the template that will
contact the carcass from contamination.
3. Locate the belly, ham, and jowl sampling sites using
illustrations and directions in Figure 3 (swine carcass sampling
locations).
4. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the ham sample area (Figure 3) is within easy reach
from the ladder.
5. Hold the sponge bag at the top corner by the wire closure, then
tear off the clear perforated strip at the top of the bag. Open the
bag.
6. Remove the cap from sterile BPD bottle, being careful not to
touch the bottle opening. Do not contaminate the lid.
7. Carefully pour about half of the contents of the sterile BPD
bottle (10 ml) into the sponge bag to moisten the sponge. Put the lid
back on the BPD bottle.
8. Close the top of the bag by pressing the wire closures together.
Use hand pressure from the outside of the bag and carefully massage the
sponge until it is FULLY HYDRATED (moistened).
9. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag orienting one narrow end of the sponge
up toward the opening of the bag. Do NOT open the bag or touch the
sponge with your fingers. While holding the bag, gently squeeze any
excess fluid from the sponge using hand pressure from outside. The
whole sponge should still be inside the bag.
10. Open the bag containing the sponge, being careful not to touch
the inner surface of the bag with your fingers. The wire closure at the
top of the bag should keep the bag open.
11. Put on a pair of sterile gloves.
12. Carefully remove the moistened sponge from the bag with the
thumb and fingers (index and middle) of your sampling hand.
13. With the other hand, retrieve the template by the outer edge,
taking care not to contaminate the inner edges of the sampling area of
the template.
14. Locate the belly sampling area (Figure 2). Place the template
over this location.
15. Hold the template in place with one gloved hand. Remember, only
the sponge should touch the sampling area. Take care not to contaminate
this area with your hands.
16. With the other hand, wipe the sponge over the enclosed sampling
area (10 cm x 10 cm) for a total of approximately 10 times in the
vertical and 10 times in the horizontal directions. The pressure for
swabbing would be as if you were removing dried blood from the carcass.
However, the pressure should not be too hard as to crumble or destroy
the sponge.
Note: The template may need to be ``rolled'' from side to side
during swabbing since the surface of the carcass is not flat. This
ensures that the 100 cm2 area is enclosed while swabbing.
17. After swabbing the belly area, transfer the template to the
same hand that is holding the sponge. Do not contaminate the sponge or
the inner edges of the sampling area of the template.
18. Climb the ladder or platform, holding onto the handrail with
the hand used to hold the sampling template in place. Once at a
convenient and safe height for sampling the ham, transfer template back
to the ``climbing'' hand (hand used to hold onto the rail while
climbing the ladder), taking care not to contaminate the sponge or the
inner edges of the template.
19. Repeat steps 14-16 for the ham sampling area, using the SAME
surface of the sponge used to swab the belly area.
20. After swabbing the ham area, carefully place the template back
to the same hand that is holding the sponge. Do not contaminate the
sponge or the inner edges of the sampling area of the template.
21. While holding the handrail, climb down from the ladder.
22. Transfer the template back to the ``climbing'' hand (hand used
to hold onto the rail while descending the ladder), taking care not to
contaminate the sponge or the inner edges of the template.
23. Repeat steps 14-16 for the jowl area, using the ``clean''
surface or side (the side that was not previously used to swab the
belly/ham areas).
24. After swabbing the jowl area, carefully place the sponge back
into the sponge bag. Do not touch the surface of the sponge to the
outside of the sponge bag.
25. Add the additional BPD (about 15 ml) to the bag to bring the
total volume to approximately 25 ml.
26. Press wire closures of the sponge bag together, expel excess
air, then fold down the top edge of the bag 3 or 4 times. Secure the
bag by folding the attached wire tie back against the bag. Place the
closed sponge bag into the second bag and close the second bag
securely.
27. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section).
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Sample Shipment
Samples analyzed on-site must be analyzed as soon after collection
as possible. If no on-site facilities are available, the samples must
be shipped the same calendar day as collected, to
[[Page 38933]]
an outside laboratory. The samples must be analyzed no later than the
day after collection.
1. Prechill shipping container by placing the open shipping
container in the refrigerator at least the day before sampling.
2. Place the appropriately-labeled, double-bagged sample(s) in the
prechilled shipping container in an upright position to prevent
spillage. Newspaper may be used for cushioning the sample and holding
it in the upright position. If more than one sample is collected during
the day, take steps to ensure that samples are maintained at
refrigeration temperature. Refrigeration temperatures help limit
multiplication of any microorganisms present which ensures the most
accurate results.
3. Place a corrugated cardboard pad on top of samples. This
corrugated cardboard pad prevents direct contact of frozen gel packs
with the samples. Next place the frozen gel pack(s) on top of the
corrugated pad. Use sufficient frozen coolant to keep the sample
refrigerated during shipment to the designated laboratory. Insert foam
plug and press it down to minimize shipper head space.
4. Ship samples (via overnight delivery or courier) to the assigned
laboratory.
Analytical Methods
Samples must be analyzed using one of the E. coli (Biotype I)
quantitation methods found in the Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC), International, 16th
edition, or by any method which is validated by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95% upper and lower confidence limits of
the appropriate MPN index.
Suggested Quantitation Schemes
If a generic one ml plating technique is used for E. coli
quantitation for cattle or swine carcass sponging sample analysis, the
plate count would be divided by 12 to equal the count per cm\2\. To
cover the marginal and unacceptable range for E. coli levels (described
in later section), the undiluted sample extract, a 1:10, a 1:100, a
1:1,000 and a 1:10,000 dilution should be plated, preferably in
duplicate. Higher or lower dilutions may need to be plated based on the
specific product.
If a hydrophobic grid membrane filtration method were used, the
only difference would be filtration of one ml of the undiluted sample
extract, 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
Additional dilutions of the original extract may need to be used if
a three tube MPN protocol is used. The three highest dilutions that
were positive for E. coli are used to calculate the MPN. MPN values
from the appropriate MPN Table represent the count per ml of original
extract and therefore must be divided by 12 to obtain the count per
cm\2\ of carcass surface area.
Record Keeping
Each test result must by recorded in terms of colony forming units
per square centimeter (cfu/cm\2\). A process control table or chart can
be used to record the results and facilitate evaluation. Results should
be recorded in the order of sample collection and include information
useful for determining appropriate corrective actions when problems
occur. The information needed for each sample includes date and time of
sample collection, and, if more than one slaughter line exists, the
slaughter line from which the sample was collected. These records are
to be maintained at the establishment for twelve months and must be
made available to Inspection Program employees on request. Inspection
personnel review results over time, to verify effective and consistent
process control.
For E. coli testing to be the most useful for verifying process
control, timeliness is important and the record should be updated with
the receipt of each new result. Detailed records should also be kept of
any corrective actions taken if process control deviations are detected
through microbiological testing.
Applying Performance Criteria to Test Results
Categorizing Test Results
E. coli test levels have been separated into 3 categories for the
purpose of process control verification: acceptable, marginal, and
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper
limits for the acceptable and marginal ranges were denoted by m and M.)
These categories are described by slaughter species in Table 3.
Table 3.--Values for Marginal and Unacceptable Results for E. Coli Performance Criteria
----------------------------------------------------------------------------------------------------------------
Slaughter class Acceptable range Marginal range Unacceptable range
----------------------------------------------------------------------------------------------------------------
Cattle............................... Negative*.............. Positive but not above Above 100 cfu/cm\2\.
100 cfu/cm\2\.
Swine................................ 10 cfu/cm\2\........... Above 10 cfu/cm\2\ but Above 10,000 cfu/cm\2\.
not above 10,000 cfu/
cm\2\.
----------------------------------------------------------------------------------------------------------------
* It should be noted that negative here is defined by the sensitivity of the sampling and test method used in
the Baseline survey (5 cfu/cm\2\ carcass surface area).
To illustrate the use of Table 3, consider a steer/heifer slaughter
establishment. E. coli test results for this establishment will be
acceptable if negative, marginal if positive but not above 100 cfu/
cm\2\, and unacceptable if above 100 cfu/cm\2\.
Verification Criteria
The verification criteria are applied to test results in the order
that samples are collected. The criteria consist of limits on
occurrences of marginal and unacceptable results.
As each new test result is obtained, the verification criteria are
applied anew to evaluate the status of process control with respect to
fecal contamination.
1. An unacceptable result should trigger immediate action to review
process controls, discover the cause if possible, and prevent
recurrence.
2. A total of more than three marginal or unacceptable results in
the last 13 consecutive results also signals a need to review process
controls.
This way of looking at the number of marginal and unacceptable
results is described as a ``moving window'' approach in the regulation.
With this approach, results are accumulated until 13 have been accrued.
After this, only the most recent 13 results--those in the ``moving
window''--are considered.
An example of a record of results for Steer/Heifer testing is shown
(in table form) below for an establishment performing two tests per
day.
[[Page 38934]]
----------------------------------------------------------------------------------------------------------------
Number
Time Test result Result Result marginal or
Test # Date collected (cfu/cm\2\) unacceptable? marginal? unacceptable Pass/fail?
in last 13
----------------------------------------------------------------------------------------------------------------
1...... 10-07 08:50 10............. No............. Yes............ 1 Pass
2...... ......... 14:00 Negative....... No............. No............. 1 Pass
3...... 10-08 07:10 50............. No............. Yes............ 2 Pass
4...... ......... 13:00 Negative....... No............. No............. 2 Pass
5...... 10-09 10:00 Negative....... No............. No............. 2 Pass
6...... ......... 12:20 Negative....... No............. No............. 2 Pass
7...... 10-10 09:20 80............. No............. Yes............ 3 Pass
8...... ......... 13:30 Negative....... No............. No............. 3 Pass
9...... 10-11 10:50 Negative....... No............. No............. 3 Pass
10..... ......... 14:50 Negative....... No............. No............. 3 Pass
11..... 10-14 08:40 50............. No............. Yes............ 4 Fail
12..... ......... 12:00 Nonegative..... No............. No............. 4 Fail
13..... 10-15 09:30 Negative....... No............. No............. 4 Fail
14..... ......... 15:20 Negative....... No............. No............. 3 Pass
15..... 10-16 07:30 Negative....... No............. No............. 3 Pass
16..... ......... 11:40 Negative....... No............. No............. 2 Pass
17..... 10-17 10:20 120............ Yes............ No............. 3 Fail
----------------------------------------------------------------------------------------------------------------
The following observations can be made on this example:
1. As of 10-14 at 08:40, there are four marginal or unacceptable
results in the last 11 results, which exceeds the limit of 3 in 13
consecutive tests.
2. The limit of 3 in 13 also is exceeded for the next two tests,
but since no new marginal or unacceptable result has occurred, these
failures should not be treated as evidence of a new problem. The log or
documentation of corrective action taken for the first failure should
be adequate to verify that the deviation or problem was addressed.
3. On 10-15 at 15:20 the number of marginal or unacceptable results
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped and replaced by an acceptable result as the 13-
test window moves ahead 1 test.
4. The result for 10-17 at 10:20 exceeds 100 and is unacceptable.
Figure 4 shows the same results as the above example but the
results are displayed in chart form. The numbers along the horizontal
axis of the graph (x-axis), refers to the test number in the chart
above. The information for each test result, such as the time and date
the sample was collected could also be recorded on the chart.
BILLING CODE 3410-DM-P
[[Page 38935]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.021
[[Page 38936]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.022
[[Page 38937]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.023
[[Page 38938]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.024
BILLING CODE 3410-DM-C
[[Page 38939]]
Appendix G--Guidelines for Escherichia coli Testing for Process Control
Verification in Poultry Slaughter Establishments
Introduction
Under the Pathogen Reduction/HACCP Regulation, all poultry
slaughter establishments will be required to test carcasses for generic
E. coli as a tool to verify process control. This document outlines the
sampling and microbial testing that should be followed to meet this
requirement. It also gives guidance to interpreting your results. This
document is a supplement to the Regulation, but not a substitute for
it. Further in-depth details of the program may be found in the
Regulation. Please provide these guidelines to your company
microbiologist or testing laboratory in order to help you meet the
regulatory requirements for generic E. coli testing.
Guidelines for Sample Collectors/Microbiologists
Background
This sampling protocol has been prepared to support the Pathogen
Reduction/HACCP Regulation. Carcass sampling for broiler and turkey
carcasses remain the nondestructive whole bird rinse which was used in
the FSIS Nationwide Microbiological Baseline Data Collection Programs.
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control across the
nation. It is imperative that all like establishments adhere to the
same sampling and analysis requirements detailed here, without
deviation. These sampling and analytical procedures may be directly
written into your establishment's individual HACCP plan.
Poultry carcasses must be sampled after the chill tank at the end
of the drip line or last readily accessible point prior to packing/cut-
up. This sample collection location is the same as that in the FSIS
baseline studies, making samples taken here comparable to the
nationwide baseline performance criteria.
Pre-sampling Preparation
Sample collection will be carried out by the individual designated
in the establishment's written protocol for microbiological sampling.
The protocol should include a check list of tasks to be performed prior
to sample collection, materials needed for sample collection, random
selection procedures, where the samples will be analyzed (on-site
versus off-site), and other information that will aid the sample
collector. As stated previously, this guideline can be a part of the
plant's sample collection guidelines, but plant specific details and
procedures will need to be included. Sampling supplies, such as sterile
gloves, sterile sampling solutions, hand soap, sanitizing solution,
etc., need to be assembled prior to beginning sample collection.
Sterile sampling solutions, Butterfield's phosphate diluent (BPD),
can be stored at room temperature. However, at least on the day prior
to sample collection, check solutions for cloudiness (DO NOT use
solutions that are cloudy, turbid or contain particulate matter) and
place the number of containers of sampling solution (BPD) that will be
needed for the next day's sampling in the refrigerator.
To obtain the most accurate results, samples should be analyzed as
soon after collection as possible. However, if samples must be
transported to an off-site laboratory, the samples need to be
maintained at refrigeration temperatures until transport, then shipped
refrigerated via an overnight delivery service to the laboratory
performing the analysis. Samples analyzed off-site must be picked up by
the overnight courier the SAME calendar day the sample is collected.
The sample must arrive at the laboratory no later than the day after
the sample is collected. Samples shipped to an outside laboratory must
be analyzed no later than the day after collection. The following
section gives information on shipping containers and transporting
samples to off-site facilities.
Shipping Containers and Coolant Packs
It is important that samples fit easily into the shipping
containers so that the sample bags do not break.
Correct use of the refrigerant gel-ice packs and proper packing of
the shipping container are necessary so that samples arrive at the
laboratory at an acceptable temperature. Frozen samples or samples
which are too warm are not considered valid and must not be analyzed.
Some bacteria may be damaged by temperatures that are too cold, while
temperatures that are too warm can allow bacteria to reproduce.
Maintaining samples at improper temperatures may cause inaccurate
sample results.
The sample should be kept refrigerated, NOT FROZEN, in the shipping
container prior to pickup by the courier service. The shipping
container, itself, should not be used as a refrigerator. However,
multiple samples (if needed) for that day may be stored in the open
shipping container in the cooler or refrigerator.
Sampling Frequency
Sampling frequency for E. coli testing is determined by production
volume. The required minimum testing frequencies for all but very low
production volume establishments are shown in Table 1 by slaughter
species.
Table 1.--E. coli Testing Frequencies a
------------------------------------------------------------------------
------------------------------------------------------------------------
Chickens............................ 1 test per 22,000
carcasses.
Turkeys............................. 1 test per 3,000
carcasses.
------------------------------------------------------------------------
a Note: These testing frequencies do not apply to very low volume
establishments. See Table 2.
Very Low Volume Establishments
Some establishments may be classified as very low volume
establishments based on their annual production volume. The maximum
yearly slaughter volumes for very low volume establishments are
described in Table 2.
Table 2.--Maximum Yearly Poultry Slaughter Volumes for Very Low Volume
Establishments
------------------------------------------------------------------------
Criteria (yearly slaughter
Slaughter species volume)
------------------------------------------------------------------------
Chickens.................................. Not more than 440,000 birds.
Turkeys................................... Not more than 60,000 birds.
Chickens and turkeys...................... Not more than 440,000 total,
with not more than 60,000
turkeys.
------------------------------------------------------------------------
Establishments with very low volumes are to sample the predominant
species once per week, initially, until at least 13 test results have
been obtained.
Once the initial criteria have been met for very low volume
establishments (see APPLYING PERFORMANCE CRITERIA TO TEST RESULTS), the
establishment will repeat the same sampling regime once per year, in
the 3 month period of June through August, or whenever a change is made
in the slaughter process or personnel.
Random Selection of Carcasses
Samples are to be taken randomly at the required frequency (See
section on Sampling Frequency). For example, given the frequency of
testing for turkeys is 1 (one) test per every 3,000 turkeys
slaughtered, then if a plant slaughters 1,500 turkeys an hour, 1 (one)
sample will be taken every 2 hours.
Different methods of selecting the specific carcass for sampling
could be used, but all require the use of random
[[Page 38940]]
numbers. Methods could include: using random number tables, using
calculator- or computer-generated random numbers, drawing cards, etc.
When selecting the random numbers, use the method(s) currently in use
at the establishment for other sampling programs, if other programs are
currently underway.
The carcass for sampling must be selected at random from all
eligible carcasses. If multiple lines exist, randomly select the line
for sample collection for that interval. Repeat the random selection
process for the next sampling interval. Each line should have an equal
chance of being selected at each sampling interval.
Poultry Carcass Selection
The poultry carcasses will be selected at random after chilling, at
the end of the drip line or last readily accessible point prior to
packing/cut-up. A WHOLE carcass is required, that is, one that has not
been trimmed.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Select the time, based on the appropriate
sampling frequency, for collecting the sample.
Selection of CHILLER: If more than one chiller system is in
operation at the time of sample collection, the chill tank from
which the sample is selected must be randomly selected.
Selection of POULTRY CARCASS: Based on the frequency of sampling
for your establishment, identify a carcass (selected by your random
number method) from the predetermined point, and then count back
five (5) carcasses and select the next carcass for sampling.
Exception: If the fifth carcass is not a WHOLE (untrimmed) bird,
count back an additional five carcasses for sample selection. Each
carcass must have an equal chance of being selected. The reason for
counting back five carcasses is to avoid any possible bias during
selection.
Aseptic Techniques/Sampling
Extraneous organisms from the environment, hands, clothing, sample
containers, sampling devices, etc., may lead to erroneous analytical
results. Stringent requirements for microbiological analysis are
necessary, therefore, use of aseptic sampling techniques and clean
sanitized equipment and supplies are of utmost importance.
There should be an area designated for preparing sampling supplies,
etc. A stainless steel, wheeled cart or table would be useful during
sampling. A small tote or caddy could be easily moved to the location
of sampling and could be used for carrying supplies, supporting sample
bags when adding sterile solutions to sample bags, etc.
Sterile gloves should be used for collecting samples. The only item
which may contact the external surface of the glove is the exposed
sample being collected. Keep in mind that the outside surfaces of the
sample container are not sterile. Do not handle the inside surface of
the sterile sample containers. Do not touch anything else. The
following procedure for putting on sterile gloves can be followed when
collecting samples:
(a) Peel open the package of sterile gloves from the top without
contaminating (touching, breathing on, contacting, etc.) the exterior
of the gloves.
(b) Remove a glove by holding it from the wrist-side opening inner
surface. Avoid any contact with the outer surface of the glove. Insert
the washed and sanitized hand into the glove, taking care not to
puncture the glove.
(c) Next, taking care not to contaminate the outer surface of the
glove, repeat the step above for the hand you will use to physically
handle the sample.
(d) If at any time you are concerned that a glove may be
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
Prior to collecting samples, review appropriate sampling steps,
random selection procedures, and other information that will aid in
sample collection.
On the day prior to sample collection, after checking for
cloudiness/turbidity, place the number of Butterfield's phosphate
diluent (BPD) containers that will be needed for the next day's
sampling in the refrigerator/cooler. If samples will be shipped to an
off-site facility, pre-chill shipping container and refrigerator packs
(follow manufacturer's directions for gel-packs).
On the day of sampling, gather all sample collection bags, sterile
gloves, sanitizer, hand soap, sterile solutions for sampling (BPD), and
specific materials listed under the Materials section of the sample
collection section for the type of carcass to be sampled. Ensure that
all sampling supplies are on hand and readily available before
beginning sample collection.
Label the sample bags before starting the sampling procedure. Use
permanent ink. If you are using paper labels, it is important that the
label be applied to the bag at normal room temperature; it will not
stick if applied in the cooler.
Outer clothing (frocks, gloves, head gear, etc.) worn in other
areas of the plant should be removed before entering the sampling area
or preparing to collect samples. Replace outer clothing removed earlier
with clean garments (i.e., laboratory coat) that have not been directly
exposed to areas of the plant outside of the sampling area.
Sanitize the sample work area surfaces by wiping with a clean
disposable cloth or paper towel dipped in a freshly prepared 500 ppm
sodium hypochlorite solution (0.05% sodium hypochlorite) or other
approved sanitizer which provides an equivalent available chlorine
concentration. The sample work area surfaces must be free of standing
liquid before sample supplies and/or product containers are placed on
them.
Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands
using disposable paper towels.
Specific Sample Collection Procedures
Chicken Carcass Rinse Sampling Procedure
Materials
1. 2 Sterile 3500 milliliter (ml) stomacher-type or ziplock-type
bags or equivalent. (The bag must be sterile and should be large enough
to hold the carcass while rinsing.)
2. 400 ml sterile, Butterfield's phosphate diluent (BPD).
3. Plastic tie wraps or equivalent (if needed to secure the bag).
4. Sterile gloves.
5. Optional--(See alternate sampling--step 10)--Sterile leak-proof
container.
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use the
predetermined random selection procedure to select the carcass to
sample. The randomly selected bird will be collected after the chiller,
at the end of the drip line as follows:
1. Ensure all sampling supplies are present and have been properly
labeled. An assistant may be helpful during sampling.
2. Open a large stomacher-type bag without touching the sterile
interior of the bag. (Rubbing the top edges of the bag between the
thumb and forefinger will cause the opening to gap for easy opening.)
3. Put on sterile gloves.
4. With one hand, push up through the bottom of the sampling bag to
form
[[Page 38941]]
a ``glove'' over one hand with which to grab the bird, while using your
other hand to pull the bag back over the hand that will grab the bird.
This should be done aseptically without touching the exposed interior
of the bag.
5. Using the hand with the bag reversed over it, pick up the bird
by the legs (hocks) through the stomacher bag. (The bag functions as a
`glove' for grabbing the bird's legs.) Take care not to contaminate the
exposed interior of the bag. Allow any excess fluid to drain before
reversing the bag back over the bird. (Alternately, have an assistant
hold open the bag. Using your gloved hand, pick up the bird by the
legs, allow any fluid to drain, and place the bird in the sampling
bag.)
6. Rest the bottom of the bag on a flat surface. While still
holding the top of the bag slightly open, add the sterile BPD (400 ml)
to the bag containing the carcass, pouring the solution over the
carcass.
(Alternately, with the aid of an assistant holding the bag open, add
the sterile BPD (400 ml) to the bag containing the carcass, pouring the
solution over the carcass.)
7. Expel most of the air from the bag, then close the top of the
bag. While securely holding the bag, rinse the bird inside and out
using a rocking motion for 30 shakes (approximately one minute). This
is done by holding the bird through the bottom of the bag with one hand
and the closed top of the bag with the other hand. Hold the bird
securely and rock it in an arcing motion, alternating the weight of the
bird from one hand to the other (motion like drawing an invisible
rainbow or arch), assuring that all surfaces (interior and exterior of
the carcass) are rinsed.
8. Rest the bag with the bird on a flat surface and, while still
supporting the bird, open the bag.
9. With a gloved hand, remove the carcass from the bag. Since the
carcass was rinsed with a sterile solution, it can be returned to the
chill tank. Be sure not to touch the interior of the bag with your
gloved hand.
10. Secure the top of the bag so that the rinse fluid will not
spill out or become contaminated.
(Alternately, at least 30 milliliters of rinse fluid can be poured into
a sterile leak-proof container to be sent to the lab for analysis.)
11. Place the sample bag (or leak-proof container) into another bag
and secure the opening of the outer bag.
12. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis.
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Turkey Carcass Rinse Sampling Procedure
Materials
1. 2 Sterile 3500 ml stomacher-type or ziplock-type bags or
equivalent. (The bag must be sterile and should be large enough to hold
the carcass while rinsing, the bags FSIS will be using for the
Salmonella sampling program measure approximately 18'' x 24''. Large
turkeys should be placed in a plain, clear polypropylene autoclave bag
, about 24'' x 30'' to 36'').
2. 600 ml sterile, Butterfield's phosphate diluent (BPD)
3. Plastic tie wraps or thick rubber bands or equivalent, if needed
to secure sample bag
4. Sterile gloves
5. Optional--sterile, leak-proof container (see step 12 Alternate
procedure)
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use a
predetermined random selection procedure to select the carcass to be
sampled. The randomly selected bird will be collected after the
chiller, at the end of the drip line as follows:
1. Ensure that all supplies are on hand and readily available. An
assistant will be needed to hold the bag for collecting the bird.
2. Have an assistant open the large sterile stomacher-type bag
(designated for rinsing the carcass) and be ready to receive the turkey
carcass. (Rubbing the top edges of the bag between the thumb and index
finger will cause the opening to gap open).
(Alternately: If no assistant is available, place the closed large
sampling bag into a bucket or pail (e.g., use the bag to ``line'' a
bucket like a trash-can liner), then open the bag. The bucket will be
used as a holder or stand to support the bag. Do not contaminate the
inner surfaces of the sampling bag.)
3. Put on sterile gloves.
4. Remove the selected turkey from the drip line by grasping it by
the legs and allowing any fluid to drain from the cavity.
5. Place the turkey carcass, vent side up, into a sterile sampling
bag. Only the carcass should come in contact with the inside of the
bag.
6. Manipulate the loose neck skin on the carcass through the bag
and position it over the neck bone area to act as a cushion and prevent
puncturing of the bag. The assistant will need to support the carcass
with one hand on the bottom of the bag.
7. While still supporting the bottom of the bag, have the assistant
open the bag with the other hand. Alternately, rest the bottom of the
bag on a pre-sanitized surface (i.e. a table), and while still
supporting the carcass in the bag, open the bag with the other hand.
8. Add the sterile BPD (600 ml) to the bag containing the carcass,
pouring the diluent over the carcass.
9. Take the bag from the assistant and expel excess air from the
bag and close the top. While securely holding the bag, rinse the bird
inside and out using a rocking motion for 30 shakes (approximately one
minute). This is done by holding the carcass through the bag with one
hand and the closed top of the bag with the other hand. Holding the
bird securely with both hands, rock in an arcing motion alternating the
weight of the bird from one hand to the other (motion like drawing an
invisible rainbow or arch), assuring that all surfaces (interior and
exterior of the carcass) are rinsed.
10. Hand the bag back to the assistant.
11. With a gloved hand, remove the carcass from the bag letting
excess fluid drain back into the bag. Since the carcass was rinsed with
a sterile solution, it can be returned to the chill tank. Be sure not
to touch the interior of the bag with your gloved hand.
12. Expel excess air, taking care not to expel any rinse fluid.
Secure the top of the bag so that the rinse fluid will not spill out or
become contaminated.
(Alternately, at least 30 milliliters of rinse fluid can be poured into
a sterile, leak-proof container and sent to the lab for analysis.)
13. Place the sample bag (or container) into another bag and secure
the opening of the outer bag.
14. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis. (See
Analytical Methods section.)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
Samples analyzed on-site must be analyzed as soon after collection
as possible. If no on-site facilities are available, the samples must
be shipped the same calendar day as collected, to an outside
laboratory. The samples must be analyzed no later than the day after
collection.
[[Page 38942]]
1. Prechill shipping container by placing the open shipping
container in the refrigerator at least the day before sampling.
2. Place the appropriately-labeled, double-bagged sample in the
prechilled shipping container in an upright position to prevent
spillage. Newspaper may be used for cushioning the sample and holding
it in the upright position. Ensure that samples are maintained at
refrigeration temperature. Refrigeration temperatures limit
multiplication of any microorganisms present.
3. Place a corrugated cardboard pad on top of samples. The
corrugated pad prevents direct contact of frozen gel packs with the
samples. Next, place the frozen gel pack(s) on top of the corrugated
pad. Use sufficient frozen coolant to keep the sample refrigerated
during shipment to the designated laboratory. Insert foam plug and
press it down to minimize shipper head space.
4. Ship samples (via overnight delivery or courier) to the assigned
laboratory.
Analytical Methods
Samples must be analyzed using one of the E. coli (Biotype I)
quantitation methods found in the Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC), International, 16th
edition, or by any method which is validated by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95% upper and lower confidence limits of
the appropriate MPN index.
Suggested Quantitation Schemes
For poultry rinse fluid samples, if a generic one ml plating
technique is used for E. coli quantitation, the plate count would not
have to be divided to get the count per ml of rinse fluid. To cover the
marginal and unacceptable range for E. coli levels (described in later
section), the undiluted extract (optional), a 1:10, a 1:100, a 1:1,000
and a 1:10,000 dilution should be plated, preferably in duplicate.
Higher or lower dilutions may need to be plated based on the specific
product.
If a hydrophobic grid membrane filtration method were used, the
only difference would be filtration of one ml of the undiluted extract
(optional), 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
Additional dilutions of the original extract may need to be used if
a three tube MPN protocol is used. The three highest dilutions that
were positive for E. coli are used to calculate the MPN.
Record Keeping
Results of each test must by recorded, in terms of colony forming
units per milliliter rinse fluid (cfu/ml) for chicken and turkeys. A
process control table or chart can be used to record the results and
facilitate evaluation. Results should be recorded in the order of
sample collection and include information useful for determining
appropriate corrective actions when problems occur. The information
needed for each sample includes date and time of sample collection,
and, if more than one slaughter line exists, the slaughter line from
which the sample was collected. These records are to be maintained at
the establishment for twelve months and must be made available to
Inspection Program employees on request. Inspection personnel review
results over time, to verify effective and consistent process control.
For E. coli testing to be the most useful for verifying process
control, timeliness is important and the record should be updated with
the receipt of each new result. Detailed records should also be kept of
any corrective actions taken if process control deviations are detected
through microbiological testing.
Applying Performance Criteria to Test Results
Categorizing Test Results
E. coli test levels have been separated into 3 categories for the
purpose of process control verification: acceptable, marginal, and
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper
limits for the acceptable and marginal ranges were denoted by m and M.)
These categories are described by slaughter species in Table 3.
Table 3.--Values for Marginal and Unacceptable Results for E. coli Performance Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
Slaughter class Acceptable range Marginal range Unacceptable range
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chicken............................... 100 cfu/ml or less......................... Over 100 cfu/ml but not over Above 1,000 cfu/ml.
1,000 cfu/ml.
Turkey................................ NA *....................................... NA *.......................... NA *.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The FSIS Baseline study has not been completed for this slaughter class. Levels will be set upon completion of this baseline.
To illustrate the use of Table 3, consider a chicken slaughter
establishment. E. coli test results for this establishment will be
acceptable if not above 100 cfu/ml, marginal if above 100 cfu/ml but
not above 1,000 cfu/ml, and unacceptable if above 1,000 cfu/ml.
Verification Criteria
The verification criteria are applied to test results in the order
that samples are collected. The criteria consist of limits on
occurrences of marginal and unacceptable results.
As each new test result is obtained, the verification criteria are
applied anew to evaluate the status of process control with respect to
fecal contamination.
1. An unacceptable result should trigger immediate action to review
process controls, discover the cause if possible, and prevent
recurrence.
2. A total of more than three marginal or unacceptable results in
the last 13 consecutive results also signals a need to review process
controls.
This way of looking at the number of marginal and unacceptable
results is described as a ``moving window'' approach in the regulation.
With this approach, results are accumulated until 13 have been accrued.
After this, only the most recent 13 results--those in the ``moving
window''--are considered.
An example of a record of results for Chicken testing is shown (in
table form) below for an establishment performing two tests per day.
[[Page 38943]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number
Time Test result marginal or
Test No. Date collected (cfu/ml) Result unacceptable? Result marginal? unacceptable Pass/Fail?
in last 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................. 10-07 08:50 120 No.................. Yes................ 1 Pass.
2.................................. ........... 14:00 10 No.................. No................. 1 Pass.
3.................................. 10-08 07:10 150 No.................. Yes................ 2 Pass.
4.................................. ........... 13:00 50 No.................. No................. 2 Pass.
5.................................. 10-09 10:00 (\1\) No.................. No................. 2 Pass.
6.................................. ........... 12:20 10 No.................. No................. 2 Pass.
7.................................. 10-10 09:20 800 No.................. Yes................ 3 Pass.
8.................................. ........... 13:30 10 No.................. No................. 3 Pass.
9.................................. 10-11 10:50 10 No.................. No................. 3 Pass.
10................................. ........... 14:50 10 No.................. No................. 3 Pass.
11................................. 10-14 08:40 500 No.................. Yes................ 4 Fail.
12................................. ........... 12:00 30 No.................. No................. 4 Fail.
13................................. 10-15 09:30 10 No.................. No................. 4 Fail.
14................................. ........... 15:20 10 No.................. No................. 3 Pass.
15................................. 10-16 07:30 10 No.................. No................. 3 Pass.
16................................. ........... 11:40 10 No.................. No................. 3 Pass.
17................................. 10-17 10:20 1,200 Yes................. No................. 3 Fail.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Negative.
The following observations can be made on this example:
1. As of 10-14 at 08:40, there are four marginal or unacceptable
results in the last 11 results, which exceeds the limit of 3 in 13
consecutive tests.
2. The limit of 3 in 13 also is exceeded for the next two tests,
but since no new marginal or unacceptable result has occurred, these
failures should not be treated as evidence of a new problem. The log or
documentation of corrective action taken for the first failure should
be adequate to verify that the deviation or problem, if any, was
addressed.
3. On 10-15 at 15:20 the number of marginal or unacceptable results
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped replaced by an acceptable result as the 13-test
window moves ahead 1 test.
4. The result for 10-17 at 10:20 exceeds 1,000 and is unacceptable.
The Figure 1 shows the same results as above displayed in chart
form. The numbers along the horizontal axis of the graph (x-axis) refer
to the test number in the chart above. The information for each test
result, such as the time and date the sample was collected could also
be recorded on the chart.
BILLING CODE 3410-DM-P
[[Page 38944]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.025
BILLING CODE 3410-DM-C
[[Page 38945]]
Note: The following Supplement will not appear in the Code of
Federal Regulations.
Supplement--Final Regulatory Impact Assessment for Docket No. 93-
016F, ``Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems.''
Table of Contents
I. Introduction
A. Purpose
B. Methodology
C. Summary Comparison of Costs and Benefits--Proposal to Final
II. Regulatory Alternatives
A. Market Failure
B. General Regulatory Approaches
C. Need For Improved Process Control
D. Regulatory Alternatives for Process Control
1. Mandatory HACCP
2. Alternatives to Mandatory HACCP
E. Comments on Analysis of Regulatory Alternatives
III. Summary of Impacts
A. Introduction
B. Net Benefit Analysis
C. Impact on ``Smaller'' Businesses
D. Effect on Retail Price
E. Impact on International Trade
F. Impact on Agency Costs
G. Impact on State Programs
H. Consumer Welfare Analysis
IV. Analysis of Public Health Benefits
A. Introduction
B. FSIS Risk Assessment
C. Risk Assessment Framework
D. FSIS Data Initiatives
E. ARS Food Safety Research Program
F. Analysis of Comments on Public Health Benefits
1. Incidence of Foodborne Illness
2. Cost of Foodborne Illness
3. Percentage of Foodborne Illness and Cost of Foodborne Illness
Attributable to Meat and Poultry
4. Pathogens Addressed by the Rule
5. Effectiveness of the Rule in Reducing Pathogens
6. Estimated Reduction in Cost of Foodborne Illness
G. Summary
V. Cost Analysis
A. Introduction
B. Methodology for Cost Analysis
C. Regulatory Flexibility
D. Final Cost Estimates
1. Sanitation Standard Operating Procedures
2. Costs of Meeting Pathogen Reduction and Microbial Sampling
3. HACCP Programs--Plan Development and Annual Reassessment
Costs
4. HACCP Programs--Recordkeeping Costs
5. HACCP Programs--Training Costs
6. HACCP Programs--Impact on Total Quality Control/Overtime
Issues
E. Summary of Costs for Low Volume Producers
Appendix A to Final Regulatory Impact Assessment
I. Introduction
A. Purpose
In docket No. 93-016F, the Food Safety and Inspection Service
(FSIS) is promulgating new regulations that require an estimated 9,079
inspected meat and poultry establishments to adopt a Hazard Analysis
and Critical Control Points (HACCP) processing control system covering
all production operations within 3\1/2\ years of final rule
publication. The regulation also requires that all 9,079 establishments
adopt and implement standard operating procedures (SOP's) for
sanitation and establishes, for the first time, food safety performance
standards for microorganisms on raw meat and poultry products. This
final rule establishes pathogen reduction performance standards for
Salmonella that are established using the current pathogen prevalence
as determined by the national baseline studies. These standards are not
directed at judging whether specific lots of a product are adulterated
under the law. Rather, compliance with the standards will be determined
by a statistical evaluation of the prevalence of bacteria in each
establishment's products. FSIS will implement sampling programs to
determine compliance with the Salmonella standard. The rule does not
require inspected establishments to test for Salmonella. The pathogen
reduction performance standards apply to 2,682 slaughter establishments
and another estimated 2,840 establishments that produce raw ground
product but do not have slaughter operations.
The final rule also requires that all slaughter establishments test
for generic E. coli to verify process control for fecal contamination
during slaughter and sanitary dressing. Results will be measured
against performance criteria established from the national baseline
surveys. Under this final rule, the 2,682 inspected slaughter
establishments will be required to verify by microbial testing that
they are controlling their slaughter and sanitary dressing processes in
accordance with the performance criteria. The rule establishes testing
frequencies based on production levels, but does not establish the
performance criteria as enforceable regulatory standards. As the
preamble points out, the criteria will be flexible and subject to
change as FSIS and the industry gain experience with them and
accumulate more data on establishment performance. The criteria are
intended specifically to provide an initial basis upon which slaughter
establishments and FSIS can begin to use microbial testing to evaluate
the adequacy of establishment controls for slaughter and sanitary
dressing procedures.
The objective of this regulation is to reduce the risk of foodborne
illness from meat and poultry. The focus is on reducing and eventually
minimizing the risk from the following four pathogens:
Campylobacter jejuni/coli.
Escherichia coli O157:H7.
Listeria monocytogenes.
Salmonella.
This document is the final Regulatory Impact Analysis (RIA)
prepared in compliance with the provisions of Executive Order 12866 and
analyses requirements of the Regulatory Flexibility Act (P.L. 96-354)
and the Unfunded Mandates Reform Act (P.L. 104-4). The purpose of this
final RIA is to evaluate alternatives to and costs and benefits
associated with a mandatory HACCP-based regulatory program for all meat
and poultry establishments under inspection.
B. Methodology
The methodology used to develop cost estimates for this final RIA
is relatively straightforward. The costs estimates are based on data
for average wages, the cost of specific processing equipment or the
cost of conducting specific laboratory analyses.
The benefits analysis is less straightforward. The analysis has
defined regulatory effectiveness as the percentage of pathogens
eliminated at the manufacturing stage. The benefits analysis concludes
that there is insufficient knowledge to predict with certainty the
effectiveness of the proposed rule. Without specific predictions of
effectiveness, FSIS has calculated projected health benefits for a
range of effectiveness levels.
The link between regulatory effectiveness and health benefits is
the assumption that a reduction in pathogens leads to a proportional
reduction in foodborne illness. FSIS has presented the proportional
reduction calculation as a mathematical expression that facilitates the
calculation of a quantified benefit estimate for the purposes of this
final RIA. FSIS has not viewed proportional reduction as a risk model
that would have important underlying assumptions that merit discussion
or explanation. For a mathematical expression to be a risk model, it
must have some basis or credence in the scientific community. That is
not the case here. FSIS has acknowledged that very little is known
about the relationship between pathogen levels at the manufacturing
[[Page 38946]]
stage and dose, i.e., the level of pathogens consumed.
There are many factors that play important roles in the actual link
between pathogen levels at the manufacturing stage and frequency of
foodborne illness. First, the effectiveness definition of ``percentage
of pathogens reduced'' can refer to the percentage of packages that
contain pathogens or the level of pathogens within packages. The
pathogens-to-illness relationship is further complicated because cross-
contamination in kitchens is believed to play a major role. It can not
be assumed that a reduction in the number of pathogens present in a
package of meat or poultry will prevent a cross-contamination related
illness. On the other hand, given that the number of consumed pathogens
necessary to cause illness (threshold) can be different for every
possible pathogen or individual combination, a reduction in pathogen
levels at the time of packaging may prevent illness for many cross-
contamination scenarios.
These types of unknowns illustrate why the relationship between
pathogen levels and foodborne illness levels remains unknown. As stated
above, without a known relationship, FSIS has used the proportional
reduction assumption to provide a quantified estimate, recognizing that
the real relationship is probably different for each pathogen and
category of meat and poultry product.
Risk minimization as the objective of this rule means the
elimination of most foodborne illness caused by the contamination of
meat and poultry products in inspected establishments by any of the
four pathogens listed above. The reduction in pathogens needed to do
this is unknown and would vary for individual pathogens and products.
This final RIA includes a discussion of the status of risk
assessment for foodborne pathogens that responds to the new
Departmental guidelines for preparing risk assessments contained in
Departmental Regulation 1521-1, December 21, 1995. Although the
statutory requirements for risk analysis included in the Federal Crop
Insurance Reform and Department of Agriculture Reorganization Act of
1994 (P.L. 103-354) do not apply to this final rule, there were public
comments on the need for additional risk assessment or risk analysis.
This final RIA includes the Agency's response to those comments.
On February 3, 1995, FSIS published a preliminary RIA as part of
the proposed Pathogen Reduction HACCP rule (60 F.R. 6871). The
preliminary RIA announced the availability of a detailed supplemental
cost analysis, titled ``Costs of Controlling Pathogenic Organisms on
Meat and Poultry,'' which was available from the FSIS Docket Clerk
during the comment period. This final RIA will refer to the analysis
published with the proposed rule and the supplemental cost analysis
collectively as the ``preliminary analysis.''
During the public comment period the Department conducted a number
of public hearings, technical conferences and information briefings. On
May 22, 1995, the Agency conducted a special hearing in Kansas City
dealing with the impacts of the proposed rule on small businesses. In
July 1995, FSIS conducted a survey of the State inspection programs to
collect additional information to assess the impact on State
establishments.
This final RIA is based on the preliminary RIA, the supplemental
cost analysis, all written public comments, the records from public
hearings including the meeting on small business impacts, the survey of
State programs, and any new information or data that have become
available during the comment period. The analysis also refers
specifically to cost estimates developed by the Research Triangle
Institute (RTI) during personal interviews with nine establishments
that previously participated in the FSIS HACCP Pilot Program. The RTI
report, HACCP Pilot Program Cost Findings, August 31, 1994, which was
referred to in both written and public hearing comments were developed
under contract to FSIS in 1994.
C. Summary Comparison of Costs and Benefits--Proposal to Final
FSIS estimated that the proposed rule would have 20-year industry
costs of $2.2 billion. Those costs are presented in Table 1, organized
by the regulatory components identified in the proposal.
The estimated costs for the final rule are also presented in Table
1. For some of the regulatory components, it is easy to track the costs
from the proposal to the final rule. For example, the costs for
Sanitation SOP's remain essentially the same. The reduction from $175.9
to $171.9 million reflects the change in implementation period from 90
days to six months.
The costs for developing and implementing HACCP plans are also
directly comparable. The estimated cost has increased for the HACCP
component of plan development. FSIS has increased its estimate for this
cost after reviewing the public comments and assessing the overall
impact on plan development costs of the decisions to eliminate the
requirements for implementing time/temperature and antimicrobial
treatment requirements prior to HACCP implementation. In the
preliminary analysis, the cost for developing HACCP plans was reduced
because of the experience that establishments would have gained in
developing their plans for implementing time/temperature and
antimicrobial treatment requirements.
Table 1.--Comparison of Costs--Proposal to Final
[$ Millions--Present Value of 20-year Costs]
----------------------------------------------------------------------------------------------------------------
Regulatory component Proposal Final
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's.......... 175.9a........................................ 171.9
II. Time/Temperature 45.5.......................................... 0.0
Requirements.
III. Antimicrobial Treatments 51.7.......................................... 0.0
IV. Micro Testing............ 1,396.3b...................................... 174.1
V.
Compliance with Not Separately Estimatedc..................... 55.5-243.5
Salmonella standards.
Compliance with generic Not Applicable................................ Not Separately Estimated
E. coli criteria.
VI. HACCP:
Plan Development......... 35.7.......................................... 54.8
Annual Plan Reassessment. 0.0........................................... 8.9
Recordkeeping (Recording, 456.4......................................... 440.5d
Reviewing and Storing
Data).
Initial Training......... 24.2.......................................... 22.7d
Recurring Training....... 0.0........................................... 22.1e
VII. Additional Overtime..... 20.9.......................................... 17.5d
----------------------------------------------------------------------------------
[[Page 38947]]
Subtotal--Industry 2,206.6....................................... 968.0-1,156.0
Costs.
VIII. FSIS Costs............. 28.6f......................................... 56.5
----------------------------------------------------------------------------------
Total.................. 2,235.2....................................... 1,024.5-1,212.5
----------------------------------------------------------------------------------------------------------------
a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted
because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days
after publication.
b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat
and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and
raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the
proposed sampling requirements.
c The preliminary analysis accounted for some of the cost of complying with the new standards under the
regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.
d These costs are slightly different from the proposal because of changes in the implementation schedule.
e FSIS added costs for recurring training based on the review of public comments.
f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP
verification testing.
Table 1 shows that FSIS has added two categories of HACCP costs
that were not included in the preliminary cost analysis. A cost for
recurring annual HACCP training was added in response to comments that
there would be recurring costs because of employee turnover. FSIS also
added a minimal cost for annual reassessment of HACCP plans, although
the Agency believes that reassessment will be negligible for
establishments successfully operating under a HACCP plan.
Table 1 shows that the proposed requirements for time and
temperature specifications and antimicrobial treatments have not been
included in the final rule. The preliminary analysis treated these
items as interim costs that were incurred prior to HACCP
implementation. For the time and temperature requirements, the
preliminary analysis identified both one-time capital equipment costs
and recurring recordkeeping costs. The time and temperature
recordkeeping costs were assumed to become part of the HACCP
recordkeeping costs. The recurring costs for antimicrobials were
assumed to end with HACCP implementation. The preliminary analysis
indicated that at the time of HACCP implementation, the slaughter
establishments would make a decision on whether to continue the
antimicrobial treatments and employ other methods to reduce the
microbial load on carcasses. The preliminary analysis did not, however,
include a cost component for either continuing the antimicrobial
treatments or adding alternative pathogen reduction methods.
Under the micro testing component, the final rule requires that all
2,682 slaughter establishments implement microbial sampling programs
using generic E. coli. The 20-year cost of this requirement is $174.1
million. After HACCP implementation including validation that the E.
coli performance criteria are being met, establishments may use
alternate testing programs unless FSIS specifically objects. In
addition, in the period prior to mandatory HACCP, FSIS will consider
exemptions on a case-by-case basis for establishments that are
currently using an alternative E. coli sampling frequency if the
establishment can provide data demonstrating the adequacy of its
existing program. The cost estimate of $174.1 million assumes that all
slaughter establishments continue to test at the frequencies outlined
in the final rule.
Up to this point, all the costs discussed have been predictable in
the sense that they refer to a specific requirement directing all
establishments or a specific category of establishments to take a well-
defined action. FSIS has developed point estimates for all predictable
costs. In contrast, the pathogen reduction performance standards for
Salmonella do not prescribe a set of actions that establishments must
take. Because the standards are set using the national prevalence
estimates from the baseline studies, the Agency is also not able to
predict how many establishments are already meeting the standards or
how many will have to modify their current operations to comply.
The cost analysis in Section V recognizes that the performance
standards create a set of potential costs for 5,522 establishments,
2,682 slaughter establishments and another estimated 2,840
establishments that produce raw ground product but do not have
slaughter operations. The analysis estimates potential costs by
developing two scenarios that lead to a range of possible costs
depending on how the different industry sectors will respond to the new
standards and depending on how many establishments will need to modify
their production processes in order to comply.
Reducing pathogens for slaughter establishments involves either
modifying the incoming animals or birds, improving the dressing
procedures so as to reduce contamination during procedures such as hide
removal and evisceration, or using interventions such as antimicrobial
treatments to kill or remove the pathogens following contamination. For
many establishments, the process of implementing HACCP programs may, by
itself, improve the dressing procedures sufficiently to meet the new
standards. Other establishments may have to choose between slowing
production lines, modifying some attribute of their incoming live
animals or birds, or adding post-dressing interventions such as the new
steam vacuum process or antimicrobial rinses.
The 2,840 raw ground processing operations will have to control
their incoming ingredients either by conducting their own testing or by
requiring that suppliers meet purchase specifications. The cost
analysis also recognizes that even though the rule does not require the
2,682 slaughter establishments to test for Salmonella, some
establishments may conduct their own Salmonella testing programs to
avoid failing a series of tests conducted by the Agency. Thus, it can
be argued that the Agency's intent to implement establishment specific
testing for Salmonella is indirectly requiring the industry to
routinely monitor their Salmonella levels to assure they will be in
compliance.
As shown in Table 1, the two scenarios developed in the cost
analysis lead to a range in cost estimates of $55.5 to $243.5 million
to comply with the new pathogen reduction standards. Some of these
costs are contained in the
[[Page 38948]]
Table 1 proposal costs of $51.7 for antimicrobial treatments and the
$1,396.3 for micro testing that included the cost of having 5,522
establishments conduct daily Salmonella testing for each species
slaughtered and each variety of raw ground product produced.
The two cost scenarios were developed to illustrate potential costs
for compliance with standards established using the current pathogen
prevalence as determined by the national baseline studies. These
standards move the Agency's regulatory program in the direction of
meeting the food safety objective of minimizing the risk of foodborne
illness from pathogens that contaminate meat and poultry products. The
Agency has stated its intent to establish tighter standards over time.
The Agency recognizes that future tighter standards could impose a new
set of compliance costs. To illustrate, where the use of hot water
rinses may be adequate to assure compliance with the Salmonella
standards as established for this rule, such rinses may not be adequate
to assure compliance with future standards. Any change in the standards
will, however, be implemented through additional rulemaking. At that
time the Agency will have extensive data on the distribution of
pathogens by establishment and better data on the cost and
effectiveness of different interventions. These data enhancements will
allow for improved cost analysis of future standard setting activities.
Inspected establishments need to consider the Agency's overall food
safety objectives when making decisions on capital investments designed
to assure compliance with the food safety standards established by this
rulemaking.
The cost analysis in Section V also recognizes that the performance
criteria for generic E. coli create a set of potential costs for 2,682
slaughter establishments. A line for these costs is shown in Table 1
along with the entry that these costs were not separately quantified.
As discussed in Section V, the anticipated actions to comply with
the generic E. coli criteria are the same as the anticipated actions to
comply with the standards for Salmonella. FSIS has concluded that if
the low cost scenario for Salmonella compliance proves to be more
accurate, then the Agency would expect to see some compliance costs for
the generic E. coli performance criteria. If the high cost scenario is
correct, then the compliance actions taken to assure compliance with
the Salmonella standards should also assure compliance with the generic
E. coli criteria.
Finally, Table 1 includes a cost of $17.5 million associated with
additional overtime charges for inspection. While it is recognized that
final decisions on the future of the Agency's Total Quality Control
(TQC) program have not been made, this analysis includes a conservative
impact assumption that the existing TQC regulations will be withdrawn.
Both the preliminary and final analysis identify a maximum
potential 20-year public health benefit from $7.13 to $26.59 billion
that is tied to eliminating establishment-related contamination from
four pathogens on meat and poultry. The contamination from these four
pathogens at the manufacturing stage leads to an estimated annual cost
of foodborne illness ranging from $0.99 billion to $3.69 billion. The
maximum 20-year benefit results from eliminating this annual cost of
foodborne illness beginning in the fifth year after publication.
Although there is reason to believe significant benefits will be
generated during the first four years, for analytical purposes FSIS
used the conservative estimate that benefits do not begin until all
establishments have HACCP systems in place and pathogen reduction
standards for Salmonella apply to all establishments that slaughter or
produce raw ground product.
There are two principle reasons why benefits will begin to accrue
before the fifth year. First, the HACCP requirements and Salmonella
standards apply to large establishments at 18 months and small
establishments at 30 months. The large slaughter establishments account
for over 74 percent of total carcass weight. Second, the generic E.
coli testing requirements are effective six months after publication.
The generic E. coli results will provide both establishment management
and inspection program personnel a tool by which to assess
establishments' control over slaughter and sanitary dressing
procedures. Although the generic E. coli criteria are not being
established as regulatory standards, FSIS believes their use will lead
to improved control over slaughter and sanitary dressing procedures
which will, in turn, lead to reductions in fecal contamination and
corresponding reductions in contamination by enteric pathogens. Rather
than attempt to estimate the benefits associated with reduced
contamination resulting from use of generic E. coli testing, this
analysis has assumed public health benefits begin in the fifth year. By
that time all establishments have had an opportunity to adjust their E.
coli sampling programs based on their HACCP programs.
The low and high estimates for potential benefits are due to the
current uncertainty in estimates for incidence of foodborne illness and
death. If the low potential benefit estimate is correct, the analysis
shows that the new HACCP-based program must reduce pathogens by 15 to
17 percent for benefits to outweigh projected costs. If the high
estimate is the correct estimate, the new program needs to reduce
pathogens by only 4 to 5 percent to generate net societal benefits.
As discussed in Section III, there are other benefits to this rule
that have not been quantified. Examples include increased public
protection from physical hazards and the increased production
efficiency that accompanies improved process control.
In the preliminary analysis FSIS took the position that quantified
pathogen reduction benefits were related to the overall proposed HACCP-
based regulatory program and that there was no way to distribute
benefits among the five different components that made up the proposed
rule. Under the proposed rule it was essentially impossible to
determine the proportion of pathogen reduction benefits that could be
attributable to the proposed pathogen reduction standards versus the
proposed antimicrobial treatments or time-temperature requirements or
the proposed mandatory HACCP programs. Given the revised structure of
the final rule, this analysis attributes pathogen reduction benefits to
the requirements that all establishments implement HACCP systems and
that if those systems are implemented in slaughter establishments or
establishments shipping raw ground product, they must have critical
limits set to assure compliance with the new pathogen reduction
standards for Salmonella. However, as discussed above, FSIS believes
that pathogen reduction benefits will begin to occur when
establishments start using the generic E. coli results to assess their
control over slaughter and sanitary dressing procedures.
FSIS believes that the Sanitation SOP's component of this final
rule has significant benefits in terms of increased productivity for
inspection resources. The HACCP component also has productivity
benefits in addition to public health benefits. One of the reasons FSIS
has not yet achieved a program that can focus appropriate resources on
the risks of microbial pathogens is that in recent years
[[Page 38949]]
national budget problems have provided limited increases in Agency
resources compared to the increase in its responsibilities generated by
industry growth, the Federal takeover of more State programs, and new
food production technologies and products. For most of its history, the
inspection program was able to obtain additional resources when it took
on new responsibilities. Now FSIS is faced with taking on new
responsibilities with the same resources.
The final rule is a necessary component of an FSIS management
strategy that will raise the productivity of current resources so that
the program can maintain all its consumer protection objectives.
Raising productivity requires raising outputs, reducing inputs or any
combination of the two that gets more done for less. Productivity can
be increased in today's inspection program by: (1) focusing resource
use on the basis of risk, giving the highest priority to safety
objectives; (2) clarifying the respective responsibilities of
government and industry to assure the best use of government resources;
and (3) designing new methods of inspection that are more efficient
than existing inspection but which maintain or improve consumer
protection.
The Sanitation SOP's and HACCP requirements are designed to
accomplish objectives in all three of the above areas. With SOP's FSIS
can monitor sanitation plans with fewer resources than it takes to
conduct comprehensive sanitation reviews. The benefit of the SOP's is,
therefore, the capacity to reallocate inspection resources to other
activities where the payoff in terms of reducing the risk of foodborne
illness may be greater. With SOP's there is less likelihood that
establishments will be able to substitute the inspector's sanitation
review for their own sanitation program. Similarly, with HACCP there is
less likelihood that firms can use inspection as a substitute for their
own control programs. In both cases productivity is enhanced by
clarifying responsibilities. The benefits associated with increased
productivity are difficult to quantify because the precise reallocation
of inspection resources is not yet clear.
Finally, with the implementation of this rule, FSIS intends to
introduce new methods of inspection that are more efficient than those
currently in place. As noted above, more efficient methods is the third
way in which productivity can be increased in the inspection system.
II. Regulatory Alternatives
A. Market Failure
Consumers make choices about the food they purchase based upon
factors such as price, appearance, convenience, texture, smell, and
perceived quality. In an ideal world, people would be able to make
these decisions with full information about product attributes and
choose those foods which maximize their satisfaction. In the real
world, however, information deficits about food safety complicate
consumer buying decisions.
Since all raw meat and poultry products contain microorganisms that
may include pathogens, raw food unavoidably entails some risk of
pathogen exposure and foodborne illness to consumers. However, the
presence and level of this risk cannot be determined by a consumer,
since pathogens are not visible to the naked eye. Although they may
detect unwholesomeness from obvious indications such as unpleasant odor
or discoloration caused by spoilage microorganisms, consumers cannot
assume products are safe in the absence of spoilage. They simply have
no clear-cut way to determine whether the food they buy is safe to
handle and eat.
When foodborne illness does occur, consumers often cannot correlate
the symptoms they experience with a specific food because some
pathogens do not cause illness until several days, weeks or even months
after exposure. Thus, food safety attributes are often not apparent to
consumers either before purchase or immediately after consumption of
the food. This information deficit also applies to wholesalers and
retailers who generally use the same sensory tests--sight and smell--to
determine whether a food is safe to sell or serve.
The societal impact of this food safety information deficit is a
lack of accountability for foodborne illnesses caused by preventable
pathogenic microorganisms. Consumers often cannot trace a transitory
illness to any particular food or even be certain it was caused by
food. Thus, food retailers and restaurateurs are generally not held
accountable by their customers for selling pathogen-contaminated
products and they, in turn, do not hold their wholesale suppliers
accountable.
This lack of information applies equally to small businesses. Some
small businesses have argued for exemption from the rule because they
sell most of their product to family, friends and neighbors, but they
are overlooking the fact that perhaps the majority of foodborne illness
victims may believe they had some type of flu virus or other illness
and have no idea that their illness was foodborne and, if they do, they
have no idea as to the source. Without feedback, (i.e., without a
connection of product to illness), there is no market where buyers and
sellers have sufficient information upon which to judge purchase
decisions. Without feedback there is insufficient incentive to make
substantial improvements in process control.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen controls. The
widespread lack of information about pathogen sources means that
businesses at every level from farm to final sale can market unsafe
products and not suffer legal consequences or a reduced demand for
their product. An additional complication is that raw product is often
fungible at early stages of the marketing chain. For example, beef from
several slaughterhouses may be combined in a batch of hamburger
delivered to a fast food chain. Painstaking investigation by public
health officials in cases of widespread disease often fails to identity
foodborne illness causes; in half the outbreaks the etiology is
unknown.
Most markets in industrialized economies operate without close
regulation of production processes in spite of consumers having limited
technical or scientific knowledge about goods in commerce. Branded
products and producer reputations often substitute for technical or
scientific information and result in repeat purchases. Thus, brand
names and product reputations become valuable capital for producers.
In the U.S. food industry, nationally recognized brand names have
historically provided significant motivation for manufacturers to
ensure safe products. In recent years, more and more raw meat and
poultry have come to be marketed under brand names. Nevertheless, not
even all brand name producers produce their products under the best
available safety controls. Further, a significant part of meat and
poultry, particularly raw products, are not brand name products and are
not produced under conditions that assure the lowest practical risk of
pathogens.
The failure of meat and poultry industry manufacturers to produce
products with the lowest risk of pathogens and other hazards cannot be
attributed to a lack of knowledge or appropriate technologies. The
science and technology required to significantly
[[Page 38950]]
reduce meat and poultry pathogens and other hazards is well
established, readily available and commercially practical.
Explanations for why a large portion of the meat and poultry
industry has not taken full advantage of available science and
technology to effectively control manufacturing processes include the
following:
1. Meat and poultry processing businesses are relatively easy to
enter; there are no training or certification requirements for
establishment operators. Consequently, the level of scientific and
technical knowledge of management in many establishments is minimal.
2. The industry is very competitive and largely composed of small
and medium-sized firms that have limited capital and small profits.
3. Management in many of these establishments has little incentive
to make capital improvements for product safety because results from
that investment are not distinguishable by customers and therefore
yield no income.
In spite of these barriers, many industry establishments do produce
meat or poultry products using process controls that assure the lowest
practical risk of pathogens and other hazards.
FSIS has concluded that the lack of consumer information about meat
and poultry product safety and the absence of adequate incentives for
industry to provide more than minimal levels of processing safety
represents a market failure requiring Federal regulatory intervention
to protect public health.
B. General Regulatory Approaches
The problem of microbial pathogens in meat and poultry has become
increasingly apparent. Documented cases of foodborne illness each year,
some of which have resulted in death, represent a public health risk
that FSIS judges to be unacceptable. Within existing authorities there
are four broad regulatory approaches the Department could use to
address this unacceptable public health risk.
Market Incentives.
Information and Education.
Voluntary Industry Standards.
Government Standards.
The final rule represents the fourth approach.
The above discussion on market failure summarizes why FSIS has
concluded that the market will not address the public health risk
resulting from microbial pathogens in meat and poultry.
The role and effectiveness of consumer and food service worker
education in assuring food safety was raised in public comments. For
example, comments suggested that since most foodborne illness involves
temperature abuse or consumer/food handler mishandling, consumer
education offers the most cost-effective approach. FSIS sees a clear
role for education and agrees that education is essential for assuring
food safety. However, experience has shown that education alone has
limited effectiveness in reducing foodborne illness. The effectiveness
of education for food safety, and, indeed, for improving diets and
other food related behavior, has not been demonstrated. FSIS views
education as a valuable adjunct to other regulatory approaches, but it
has no evidence that a major increase in education expenditures will
produce the behaviors required to reduce foodborne illness.
A voluntary industry standard would call for the formation of a
standards setting group, such as the American National Standards
Institute (ANSI) to develop and publish a voluntary standard.
Compliance with such a voluntary standard would be determined by third-
party testing and certification. For example, Underwriter's Laboratory
(UL) tests and certifies electronic components for industry-wide
standards. FSIS has not seen any evidence that the industry is prepared
to undertake, or even desires a voluntary standards approach. This is
understandable. Because the principles underlying the safe production
of meat and poultry are the same regardless of who administers the
standards, an industry administered system is likely to be more
expensive and less effective than a government one. The lack of power
to mandate participation reduces the value of standard setting to
participants, since foodborne illness episodes attributable to non-
participants tend to raise suspicion of all similar products. Further,
the industry would be called upon to pay the enforcement cost which
under the present rule would be paid by the government.
For these reasons, the Department concludes that mandatory process
control regulations offer the best approach for addressing this
unacceptable public health risk.
C. Need For Improved Process Control
FSIS has determined that effective process control is needed
throughout the meat and poultry industry in order to minimize pathogen
contamination and control other health hazards. Accordingly, a
regulatory strategy has been formulated to mandate process control
improvements to achieve immediate reductions and an eventual
minimization of the risk of meat and poultry pathogens, chemical, and
physical hazards in the nation's food supply. This strategy is
supported by consumers, scientists, and the majority of meat and
poultry industry processors who already recognize the benefits of good
process control.
Process control is a proactive strategy that all segments of
industry can undertake to anticipate manufacturing problems in advance
and prevent unsafe foods from being produced. In practice, process
control is a systematic means to:
Identify and control production hazards.
Determine control points in the processing system.
Establish standard measures for each control point.
Set procedures for establishment workers to monitor
requirements.
Provide clear instructions for appropriate corrective
actions when a control point goes out of control.
Establish record-keeping to document control point
measurements.
Provide procedures for verification tests to ensure that
the system continues to operate as planned.
The process control strategy summarized in this paper is founded on
three principles:
1. USDA regulatory policy should be focused on providing a solution
to meat and poultry biological, chemical, and physical hazards that
present the highest public health risks.
2. It is essential that the Nation's food safety system address
pathogenic microorganisms which present the greatest foodborne risk to
human health.
3. These pathogens and resulting risks of foodborne illness can be
largely avoided by uniform meat and poultry industry efforts to attain
and maintain more effective methods of control during the manufacturing
process.
The focus of this strategy is explicitly on prevention; it is
designed to prevent the production of defective product as opposed to
more costly and less effective detect-and-condemn methods.
Process control is not a substitute for inspection any more than
inspection could be a substitute for process control. This distinction
is important because Federal inspection was never intended to be--and
cannot be--the front-line control for food safety in meat and poultry
processing establishments. Safety controls must be built into the
manufacturing process and be administered continuously by industry. The
objective of inspection in a process control environment is to assure
that those controls are present, adequate, and properly used.
[[Page 38951]]
To summarize, the process control regulatory strategy promulgated
by this rule will among its other well established attributes, correct
two important deficiencies in the nation's current food safety effort.
It will: (1) provide industry the tools and incentive to reduce meat
and poultry pathogens as a means to improve food safety, and (2) help
focus Federal inspection on the highest product, process and
establishment risks, and, at the same time, clarify that the industry
is responsible for producing safe meat and poultry, while the
Government's role is oversight.
Factors Considered in Evaluating a Process Control Strategy
The process control regulatory strategy was evaluated using five
factors for effectiveness. A processing control program is effective if
it:
1. Controls production safety hazards.
2. Reduces foodborne illness.
3. Makes inspection more effective.
4. Increases consumer confidence.
5. Provides the opportunity for increased productivity.
The following sections discuss these five effectiveness factors
that have been applied to evaluate process control alternatives.
Controls Production Safety Hazards
Process control is a system for identifying food hazards and
reducing or eliminating the risks they present. In operation, control
points are established in a food production line where potential health
hazards exist; management of these points has proven to be effective in
reducing the probability that unsafe product will be produced. Ongoing
records of each process control will enable establishment managers and
quality control personnel to spot trends that could lead to problems
and devise a strategy that prevents them before they occur.
Detection by end product testing is not a viable alternative to
process control because it only sorts good product from bad and does
not address the root cause of unacceptable foods. Additionally, keeping
``bad'' foods out of commerce through sorting end product is possible
only when tests and standards for sampling are well established and it
is practical only where the ``test'' is not expensive because sorting
requires a huge number of samples for reliability.
Reduces Foodborne Illness
As industry improves its control over the safety aspects of meat
and poultry production, foodborne illness will begin to decline. This
is the principal non-negotiable goal for both USDA and industry.
The precise occurrence of human health problems attributed to
pathogenic microorganisms or other potential foodborne hazards, such as
chemical contaminants, animal drug residues, pesticides, extraneous
materials, or other physical contaminants is not known. Foodborne
illness is nevertheless recognized by both domestic and international
scientists as a significant public health problem and there is wide
agreement that pathogenic microorganisms are the major cause of food-
related disease. The estimated annual (not discounted) cost of
foodborne illness attributable to meat and poultry products from the
four pathogens that are the focus of this regulation is from $1.1 to
$4.1 billion. FSIS estimates that 90 percent of this annual cost, $0.99
to $3.69 billion, is attributable to contamination that occurs in
establishments.
Makes Inspection More Effective
Currently, the FSIS inspectors in meat and poultry establishments
that are not assigned to slaughter line positions perform selected
inspection tasks that generate independent data about an
establishment's production processes and environment. This activity
produces ``snapshots'' of establishment operations at a particular
moment. In contrast, process control generates records of establishment
performance over time. These records and periodic verification
inspections will enable FSIS inspectors to see how an establishment
operates at all times, i.e., whether and where processing problems have
occurred, and how problems were addressed.
The availability of more and better processing data will establish
trends that set benchmarks from which deviations can be more quickly
and accurately assessed. USDA inspectors will be trained to spot these
deviations and take action when needed to ensure establishments bring a
faulty process back into control. This type of Federal oversight is
substantially more effective than a regulatory program that merely
detects and condemns faulty end products. In the words of the National
Advisory Committee on Microbiological Criteria for Foods,
``Controlling, monitoring, and verifying processing systems are more
effective than relying upon end-product testing to assure a safe
product.''
Increases Consumer Confidence
The number of foodborne illness outbreaks and incidents
attributable to pathogens in meat or poultry raise questions about
whether Federal inspection is as effective as it should be. Highly
visible public controversies about meat and poultry inspection indicate
an erosion of public confidence in the safety of meat and poultry
products. There are growing demands that USDA improve its regulation of
pathogens. The process control regulatory strategy described in this
paper is USDA's response to those demands.
Many outbreaks of foodborne illness have been determined to be
caused by mishandling of meat and poultry products after federally
inspected processing. USDA believes that additional efforts to reduce
pathogens during manufacturing will reduce these risks as well. This
coupled with the improved retail regulatory controls from state
adoption and enforcement of the Food Code should reduce this cause of
illness. The Food Code is an FDA publication, a reference that provides
guidance to retail outlets such as restaurants and grocery stores and
institutions such as nursing homes on how to prepare food to prevent
foodborne illness. State and local regulatory bodies use the FDA Food
Code as a model to help develop or update their food safety rules and
to be consistent with national food regulatory policy.
A significant portion of the meat and poultry industry do not take
advantage of readily available methods to control their manufacturing
processes. The Department has concluded that further regulation will
bring industry standards up to what can practically be achieved in the
manufacture of meat and poultry products through current scientific
knowledge and available process control techniques. Raising the safety
floor through regulations that mandate better process control will
demonstrate to the public that USDA and industry are making a concerted
effort to reduce the risk of foodborne illness from meat and poultry.
The economic benefits of increased consumer confidence can be
conceptually realized as the amount consumers would be willing to pay
for safer food. This ``willingness to pay'' reflects consumer desires
to avoid foodborne illness and the expected medical and other costs
associated with it. However, the data are not available to make
quantitative estimates of this benefit.
Provides the Opportunity for Increased Productivity
Better process control is a sound and rational investment in the
future of our
[[Page 38952]]
nation's meat and poultry industry. USDA's process control strategy
will educate industry management about the need and methodology for
development of a consistent, preventive, problem-solving approach to
safety hazards, which can be expanded to other business objectives such
as product quality and production efficiency. There is considerable
evidence of how process control has improved worldwide industrial
productivity in the past 40 years. This proposal will extend process
control principles to parts of the meat and poultry industry that have
not formerly used them.
Some important non-safety benefits that will accrue from industry
use of better process control methods are:
First, better production controls will result in more
efficient processing operations overall with fewer product defects.
Fewer defects mean less reworking, waste and give-away, resulting in
increased yields and more profit opportunities.
Second, better controls will significantly reduce the risk
to processors that product with food safety defects will slip into
commerce. Expensive and embarrassing product recalls can be, for the
most part, avoided or greatly reduced with proper process controls.
Third, better control of pathogens will impact all
microorganisms, including those responsible for decomposition,
resulting in quality improvement and longer shelf life for products.
Fourth, better production controls improve establishment
employee productivity which improves profit opportunities.
D. Regulatory Alternatives for Process Control
1. Mandatory HACCP
Considering the five effectiveness criteria of process control
discussed above, the most effective means for generating the benefits
reflected in these criteria is a mandatory HACCP regulatory program.
This alternative clearly meets all five criteria described above. In
fact, a mandatory HACCP program was judged to be the only option that
will effect adequate processing improvements in all establishments
throughout the industry. Only through mandatory HACCP can pathogen
risks be minimized to the fullest extent possible; thereby
significantly reducing foodborne illness, improving effectiveness of
inspection, increasing consumer confidence, and ensuring a more viable
industry. No other alternative accomplishes as much in these five areas
as mandatory HACCP.
HACCP is a process control strategy that has been scientifically
proven effective in food manufacturing establishments. HACCP is widely
recognized by scientific authorities such as the National Academy of
Sciences and international organizations such as the Codex
Alimentarius. It is used today by a number of establishments in the
food industry to produce consistently safe products. This approach has
been supported for years by numerous groups that have studied USDA meat
and poultry regulatory activities.
In 1983 FSIS asked the National Academy of Sciences (NAS) to
evaluate the scientific basis of its inspection system and recommend a
modernization agenda. The resulting report, ``Meat and Poultry
Inspection, The Scientific Basis of the Nation's Program,'' National
Academy Press, 1985 was the first comprehensive evaluation of a
scientific basis for inspection. The 1985 NAS report provided a
blueprint for change: it recommended that FSIS focus on pathogenic
microorganisms and require that all official establishments operate
under a HACCP system to control pathogens and other safety hazards.
After urging (NAS Recommendations, Page 4) the intensification of
``current efforts to control and eliminate contamination with micro-
organisms that cause disease in humans,'' NAS encouraged (Page 135)
USDA to ``move as vigorously as possible in the application of the
HACCP concept to each and every step in establishment operations, in
all types of enterprises involved in the production, processing, and
storage of meat and poultry products.''
The General Accounting Office (GAO) has also identified needed
improvements in USDA's present inspection system. In its reports and
congressional testimony, and in numerous publications, GAO has endorsed
HACCP as the most scientific system available to protect consumers from
foodborne illness. This sentiment is most clearly expressed in a May
1994 report, ``Food Safety: Risk-Based Inspections and Microbial
Monitoring Needed for Meat and Poultry,'' in which GAO recommended
development of a mandatory HACCP program that includes microbial
testing guidelines. GAO urged USDA to assist meat and poultry
establishments in the development of their microbial testing programs
by, among other things, disseminating information on the programs
already in operation.
A third major proponent of HACCP is the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF), which was established
in 1988 by the Secretary of Agriculture to advise and provide
recommendations to the Secretaries of Agriculture and Health and Human
Services on developing microbiological criteria to assess food safety
and wholesomeness. Since 1989, NACMCF has prepared a series of reports
on the development and implementation of HACCP. As one of its first
tasks, the Committee developed ``HACCP Principles for Food Production''
in November 1989. In this report, the Committee endorsed HACCP as a
rational approach to ensure food safety and set forth principles to
standardize the technique. In 1992, the Committee issued an updated
guide, ``Hazard Analysis and Critical Control Point System.''
In 1993 NACMCF defined the roles of regulatory agencies and
industry in implementing HACCP. ``The Role of Regulatory Agencies and
Industry in HACCP'' proposed responsibilities for FDA, USDA, and other
agencies and industry during various phases of HACCP implementation.
Similar suggestions for program change have been voiced by consumers,
industry, state and local government representatives, as well as other
constituent groups. For example, consumers at recent public hearings
and the HACCP Round Table supported implementation of mandatory HACCP
throughout the meat and poultry industry.
The meat and poultry industry has itself provided broad support for
HACCP as a means to control pathogens, emphasizing that HACCP-based
food production, distribution, and preparation can do more to protect
public health than any Federal inspection program. They have
recommended that HACCP be used to anticipate microbiological hazards in
food systems and to identify risks in new and traditional products.
State departments of health and agriculture have also endorsed the
HACCP approach.
2. Alternatives to Mandatory HACCP
FSIS examined six other approaches before determining that
mandatory HACCP was the most effective means for assuring process
control in the meat and poultry industries.
1. Status quo
2. Intensify present inspection
3. Voluntary HACCP regulatory program
4. Mandatory HACCP regulation with exemption for small businesses
5. Mandatory HACCP regulation only for ready-to-eat products
[[Page 38953]]
6. Modified HACCP--recording deviations and responses only
These alternatives were assessed using the five effectiveness
criteria presented in the previous section. The following six sections
summarize the appraisal of each alternative.
Status Quo
This option would essentially continue establishment processing
controls and Federal inspection as they are now. Good establishments
with adequate methods for managing process lines would probably remain
under control. The Agency, under its present authority, cannot shift
resources out of good establishments so the situation of poor
performing establishments is unlikely to change. This situation raises
immediate questions about the first factor--controls production safety
hazards--being met. Experience has proven that Federal inspection
cannot substitute for management in establishments which have
difficulty producing safe product consistently. Also, inspection cannot
be as effective in the current establishment environment as in a
process control establishment environment.
The status quo does not target industry and inspection resources on
those hazards that lead to the greatest reduction in foodborne illness
(factor two). In addition, food safety experts, consumers, and other
observers have told USDA they are not satisfied with pathogen control
by organoleptic methods as practiced in the present inspection program.
Doing nothing new would perpetuate consumer doubts about the ability of
Federal inspection to regulate pathogens which is counter to factor
four. Consequently, the Department has concluded that business as usual
is not an acceptable response to pathogens associated with meat and
poultry products. Agency public health responsibilities alone require
that more positive actions be taken.
Intensify Present Inspection
As one alternative to the proposed mandatory HACCP regulation, FSIS
could intensify its present inspection system, i.e., focus new
resources on suspected areas of risk in each establishment. This
approach would assign to FSIS responsibility for designing, testing and
mandating by specific regulation, process control systems for all meat
and poultry products with potential safety hazards. A major flaw with
this approach is that the burden of ensuring a safe product would be
placed largely on FSIS instead of industry establishments where it
belongs. Establishment management would have little motivation to
become knowledgeable about process control or to implement process
control systems.
The mandating of specific process controls has sometimes succeeded,
as a regulatory strategy, for example, in correcting food safety
problems in certain ready-to-eat products. However, these controls
largely consisted of lethal heat treatments applied during final
product processing. This approach is obviously inappropriate for
product that is marketed raw which is most frequently associated with
meat and poultry foodborne illness. The identification of processes
that can be applied to raw product in every establishment would be much
more difficult, if not impossible. Thus, intensified command-and-
control regulation fails to meet the primary criterion for process
control, i.e., control production safety hazards at all stages of meat
and poultry slaughter and processing. Related to this failing,
inspection would be ineffective without all establishments maintaining
process control systems (factor three.) This option would not only
require significant resource increases, it represents government taking
on more, not less, responsibility for the production process, making it
more difficult to focus on the highest risks of foodborne illness. With
the burden of control and monitoring on USDA's inspection force rather
than on establishment managers, industry performance in reducing
foodborne illness would be unlikely to improve (factor two).
Voluntary HACCP Regulatory Program
A voluntary HACCP program would not provide reduction of pathogens
uniformly across the processing spectrum because many in industry would
choose not to participate. Therefore voluntary HACCP would not be
sufficient to attain the necessary reduction in foodborne illness
(factor two).
Voluntary HACCP would be implemented most frequently in
establishments with good processing controls already, while
establishments with unsophisticated controls would be less likely to
participate. The explanation for this flaw is to be found in simple
economics and, to a large degree, the attitudes of establishment
management. Establishments with good processing controls now are most
likely to adopt HACCP voluntarily because their management understands
the linkage between how a product is handled during preparation and its
finished quality and safety.
Conversely, establishments without good processing controls today
are much less likely to participate in a voluntary HACCP program. These
establishments are more often operated by management that lacks the
knowledge or motivation to institute better processing controls.
Nevertheless, it is precisely this group of low performing
establishments that FSIS must reach to attain its public health goal.
Nothing short of a mandatory HACCP regulatory program will be effective
in bringing processing improvements to these marginal performers.
The Agency's regulation permitting the use of voluntary Total
Quality Control (TQC) Systems provides a useful analogy to how
effective a voluntary HACCP program would be. TQC focuses on
establishment responsibility for meeting or exceeding the standards set
by FSIS for all operations that are conducted in an establishment,
including incoming raw materials, processing procedures, critical
limits for product standards, and action limits for establishment
quality control personnel. These systems operate under Agency oversight
with an emphasis on timely and accurate recordkeeping and the necessity
for appropriate action to be taken by an establishment when a limit set
forth in an approved system is met or exceeded. However, over the last
10 years the number of establishments with active TQC Systems has
declined from a high of around 500 (approximately 8% of all
establishments) to the present 351 participating establishments
(approximately 5% of all establishments). USDA experience has shown
that a voluntary approach to HACCP would provide little assurance that
a major portion of meat and poultry products had been produced under
controls designed to minimize food safety hazards.0
Mandatory HACCP Regulation With Exemption for Small Businesses
Under this alternative, FSIS would mandate HACCP, but also provide
an exemption for some category of small businesses as was done with
nutrition labeling. While this final regulatory impact analysis does
develop very specific definitions for small and very small
establishments, the following discussion of comments uses the term
``small'' in a generic sense because many of the comments address small
establishments or small businesses without defining these terms. There
was a mix of public comments on whether or not HACCP should be
mandatory for small businesses.
[[Page 38954]]
Comments supporting an exemption from HACCP for small
establishments noted that many owner-operators of small establishments
oversee the entire operation on a daily basis and can pay closer
attention to procedures than can a large establishment. Similar
comments pointed out that small establishments pose a minimal potential
public health hazard because of the simplicity of their operations, the
slow pace of operations, and the small number of potentially affected
customers. Other comments pointed out that they sell their product to
family, friends and neighbors and that type of market provides the
greatest incentive for producing safe product.
Some commenters opposing an exemption did not want to create a two-
tiered system. Others opposing an exemption for small establishments
would require HACCP for everyone while easing the burden through
flexibility of implementation. Several of the commenters opposing any
type of exemption from HACCP identified themselves as owners of small
establishments. One commenter noted that just because small businesses
produce only 2 percent of the product does not mean they are
responsible for only 2 percent of the foodborne illness attributable to
meat and poultry.
The Agency used the evaluative factors presented above to consider
the application of the rule to small establishments. Since major goals
in implementing HACCP are to improve processing controls and
establishment performance across all of industry (factor one) as a
means to achieve foodborne illness reduction (factor two), the option
to exempt establishments that perform the least process control is
inherently flawed. USDA inspection experience shows that some of the
small establishments which would be exempted under this option have
particular difficulties maintaining control over their processing
system.
While it is true that small establishments produce a minimal amount
of the total meat and poultry supply, they do produce a full range of
products, including those most frequently associated with foodborne
illness from the meat and poultry supply.
This option also fails on factor three--provide more effective
inspection. Two different inspection systems would be needed: one risk-
based system to inspect HACCP establishments with good processing
controls; the other to provide resource intensive coverage for
establishments that largely do not. If the number of small
establishments were to increase, more inspection resources would be
required.
For these reasons, the final rule does not include an exemption for
small businesses. However, the Agency has made significant changes to
ease the burden on small business, including basing microbial sampling
programs on production volume and deferring implementation of mandatory
HACCP for small and very small businesses as defined in Section V.
Mandatory HACCP Regulation Only for Ready-to-Eat Products
This option would mandate HACCP only for establishments that
prepare ready-to-eat meat and poultry products, but not for
establishments that produce raw products. However, this decision would
leave the public without adequate protection from pathogenic
microorganisms clearly associated with product marketed in raw form.
Very little reduction in the most frequent causes of foodborne illness
(factor two) could be anticipated from this approach.
Government inspection costs would continue to increase to provide
traditional resource-intensive inspection for slaughtering and allied
processing establishments that would not be subject to mandatory HACCP.
Since most of the unsolved problems with pathogenic microorganisms are
associated with raw product and not with those products that would be
the subject of this HACCP option, this is an especially inappropriate
regulatory approach.
Modified HACCP--Recording Deviations and Responses Only
A final alternative considered would be to mandate HACCP, modified
to eliminate the record keeping burden to the inspected industry,
especially small establishments. Specifically, this option would modify
the HACCP record-keeping principles so that instead of demanding
continuous records at critical control points, companies would need to
record only deviations from critical limits and the response to them.
This would mean that HACCP-controlled operations would not generate
continuous monitoring data to reflect the operation at critical control
points, but would only record data when deviations occurred. This
arrangement eliminates the continuous picture of establishment
operations which is the underpinning of factor three--make inspection
more effective.
Such an approach would substantially reduce the paperwork burdens
associated with mandatory HACCP as recommended by NACMCF and recognized
by CODEX. However, it would also seriously compromise the usefulness of
HACCP as a means to make inspection more effective and avoid program
cost increases. Regulatory officials need to have a system which can be
reviewed in its entirety, so that a comprehensive picture of the
process is available, not just the truncated version which grows out of
recording deviations.
E. Comments on Analysis of Regulatory Alternatives
There were several general comments related to either the
alternatives discussed in the proposed rule or the level of analysis
conducted. There were comments noting that FSIS did not quantify the
costs and benefits of the regulatory alternatives. Similar comments
suggested that FSIS should have determined cost-benefit ratios for the
processed food industry or for ready-to-eat products or for small
businesses.
Generating quantitative benefit estimates for different types of
products or different industry sectors would be very difficult. The
estimates for foodborne illness attributable to meat and poultry have
not been broken down by industry sector or type of product. There are
no existing estimates for the portion of foodborne illness attributable
to meat versus poultry or raw product versus cooked or partially cooked
product.
Production volume can not be used as an indicator of potential
benefits. Foodborne illness is not proportionally related to production
volume because pathogen levels vary significantly by type of product.
As noted above, a commenter also pointed out that just because small
businesses account for only 2 percent of production does not mean that
small businesses account for only 2 percent of foodborne illness.
On the cost side, the estimates are, for the most part, based on
industry averages. In reality, costs will vary by industry sector based
on the hazards presented and the existing presence of process control.
Thus, in response to a comment that suggests that few benefits are
available from changing the process for the manufacture of processed
foods which are now produced under a zero pathogen standard, the
Department would suggest that the costs for implementing HACCP for
these products will also be low. Many ready-to-eat products such as
cooked patties and roast beef are presently produced under
comprehensive process control regulations.
One comment suggested that FSIS consider mandatory HACCP for only
firms that produce raw meat and poultry products because that sector of
the industry generates most of the problems
[[Page 38955]]
and would provide the greatest pathogen reduction benefits per dollar
of cost expended. The same commenter found it odd that the Agency did
include an alternative for mandatory HACCP for only ready-to-eat
products after acknowledging that most of the unsolved problems with
pathogenic microorganisms are associated with raw meat and poultry
products, rather than ready-to-eat products. In the above discussion of
regulatory alternatives, it was noted that mandatory HACCP for only
ready-to-eat products is an especially inappropriate regulatory
approach. In contrast, a raw product option appears attractive since
most of the unsolved problems with pathogenic microorganisms are
associated with raw product. Most establishments handle raw product
ingredients or prepare a finished raw product. Most of the cost of this
rule is associated with controlling the safety hazards of raw product
production. Extending the rule to cover all production adds little cost
while allowing a single inspection approach, avoiding confusion where
raw product production ends and ready-to-eat production begins, and
assuring that the potential hazard of recontaminating ready-to-eat
product by contact with raw ingredients is always covered by
comprehensive HACCP programs.
Other comments noted that FSIS did not analyze an option that
accounted for the savings associated with streamlining and modernizing
the inspection system or that FSIS should revise the cost-benefit
analysis to consider the savings from eliminating the current
inspection program. The savings referred to will be used to focus on
food safety risks that need more coverage.
III. Summary of Impacts
A. Introduction
This section provides a summary of the costs and benefits that will
be discussed in detail in Sections IV and V. The benefits analysis in
Section IV and this summary discuss benefits in terms of the reduction
in the cost of foodborne illness that results from reductions in
pathogen levels. There are other public health benefits beyond the
reduction of foodborne illness due to pathogenic bacteria. HACCP
systems will also provide increased public protection from risks posed
by chemical and physical hazards. There are also benefits beyond public
health benefits. As discussed in Section I, the SOP and HACCP
requirements have social benefits that derive from the capacity to
reallocate inspection resources to other activities where the payoff in
terms of reducing the risk of foodborne illness may be greater.
The February 1995 proposal and the subsequent public comment
recognized that the HACCP/Pathogen Reduction regulations would also
generate benefits for meat and poultry processors. For example, a
commenter at a public hearing provided confirmation that the insurance
industry is aware of HACCP and has offered reduced liability insurance
for firms with improved food safety controls. Other comments noted that
improved production efficiency has always been associated with improved
process control. Increased customer confidence can also be a benefit to
the extent that it has a positive influence on demand.
The benefits analysis in the preliminary RIA noted that benefits
also accrue through the reduction of operating costs like the cost of
product recalls or the cost of settling product liability claims. Other
operating costs include the loss of establishment production due to
suspensions for sanitation problems that could be reduced by improved
process control, premiums for product liability insurance, loss of
product reputation, and reduced demand when a foodborne illness
outbreak is publicized identifying a product or company.
The cost analysis in Section V addresses two types of costs
associated with this rule. There are the predictable costs associated
with requirements directing all establishments or a specific category
of establishments to take a well-defined action. Examples include the
requirements to develop SOP's and HACCP plans or the requirement to
have access to a HACCP-trained individual. This final RIA provides
point estimates for all predictable costs. There are also potential
costs that may impact some establishments because of current
establishment-specific situations. This analysis provides a range of
potential costs developed from two different scenarios of possible
establishment responses to new pathogen standards.
This summary compares both types of costs with the potential public
health benefits related to pathogen reduction, recognizing that there
are other potential benefits. The discussion in Section V notes how
this rule will set new requirements and also improve compliance with
existing requirements. Some of the potential costs discussed in Section
V are costs associated with improved compliance with existing standards
and should not necessarily be considered costs of this rulemaking.
Public comments demonstrate that the controversy in this rulemaking
derives not from the benefit cost ratio itself, which is very
favorable, but from the fact that the processors will bear most of the
costs while the public, in general, will experience the benefits. The
public includes both the consumers of meat and poultry and those who do
not consume meat or poultry but who bear the costs of illness in the
society. Another area of controversy arises from the lack of proof that
the estimated benefits will result from the promulgation of the rule.
These doubts are particularly troublesome to those who would have to
make resource investments under the rule while benefits largely accrue
to others. This is, of course, the standard controversy facing
government regulators. The essence of government regulation is that
there is a situation where the public undergoes unacceptable risk
because the current distribution of costs and benefits is unlikely to
change without government intervention. This rule represents the
Department's belief that the food safety risks being borne by the
public are unacceptable, that they can be reduced through the use of
readily available current technologies, and that the uncertainties
involved in just how much risks can be reduced should not prevent the
Department from making its best effort to reduce the risks.
B. Net Benefit Analysis
Because costs and benefits accrue at different rates over different
time periods, to compare costs and benefits it is necessary to examine
present value estimates for both cost and benefit streams. To make
these comparisons, both the preliminary analysis and this final RIA use
a 20-year time period. The present values for costs and benefits are
based on a discount rate of 7 percent, the current standard recommended
by the Office of Management and Budget.
As discussed above, the cost analysis (Section V) addresses two
types of costs. FSIS was able to develop point estimates for the direct
costs of complying with the requirements outlined in the rule that all
establishments must meet. These predictable costs include the costs of
developing and operating HACCP plans and SOP's and the costs of
required recordkeeping. There are also potential costs for
establishments that may have to purchase new equipment, or modify their
production practices to meet the pathogen reduction performance
standards for Salmonella, or actually implement Salmonella testing
programs to assure compliance with the new standards. The cost analysis
develops a range of cost estimates for these potential costs.
[[Page 38956]]
The estimated annual industry costs (not discounted) are summarized
in Table 2. These annual costs vary over the first four years as the
new HACCP-based program is undergoing its implementation phase. After
the initial four years, the recurring costs are estimated at a constant
$99.6 to $119.8 million per year. The present value of all industry
costs summarized in Table 2 for the 20-year time period is $968 to
$1,156 million as shown earlier in Table 1. This total of $968 to
$1,156 million ($0.97 to $1.16 billion) is the total industry cost for
the rule as shown in Table 3.
TABLE 2.--Summary of Annual Industry Costs--All Requirements
[$ Thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Category Year 1 Year 2 Year 3 Year 4 Year 5+
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's:
Plans and Training................................... 2,992
Observation and Recording............................ 8,345 16,691 16,691 16,691 16,691
II. E. coli Sampling:
Plans and Training................................... 2,627
Collection and Analysis.............................. 8,716 16,122 16,122 16,122 16,122
Record Review........................................ 406 752 752 752 752
III. Compliance with Salmonella Standards................ ................. 5,472-16,899 5,353-25,753 5,811-25,956 5,811-26,079
Compliance with Generic E. coli Criteria............. ................. (\1\) (\1\) (\1\) (\1\)
IV. HACCP:
Plan Development..................................... ................. 3,769 27,755 35,464 .................
Annual Plan Reassessment............................. ................. ................. 69 448 1,179
Initial Training..................................... ................. 1,270 8,284 18,435 .................
Recurring Training................................... ................. 64 542 1,877 2,799
Recordkeeping (Recording, Reviewing and Storing Data) ................. 3,050 18,479 42,478 54,097
V. Additional Overtime................................... ................. 189 837 1,711 2,125
----------------------------------------------------------------------------------------------
Total.............................................. 23,086 47,379-58,806 94,884-115,284 139,789-159,934 99,576-119,844
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Not Separately Estimated.
Table 3.-- Present Value of 20-Year Costs and Benefits
[$ Billions]
------------------------------------------------------------------------
Public health
Effectiveness in reducing pathogens in the benefits Industry
manufacturing sector (percent) ---------------- costs
Low High
------------------------------------------------------------------------
10.......................................... 0.71 2.66 0.97-1.16
20.......................................... 1.43 5.32 0.97-1.16
30.......................................... 2.14 7.98 0.97-1.16
40.......................................... 2.85 10.64 0.97-1.16
50.......................................... 3.57 13.30 0.97-1.16
60.......................................... 4.28 15.96 0.97-1.16
70.......................................... 4.99 18.61 0.97-1.16
80.......................................... 5.71 21.27 0.97-1.16
90.......................................... 6.42 23.93 0.97-1.16
100......................................... 7.13 26.59 0.97-1.16
------------------------------------------------------------------------
Note: Analysis assumes zero benefits until year 5. All elements
of the HACCP-based program will be in place 42 months after
publication of the final rule.
The public health benefits of this rule are discussed in detail in
Section IV. The benefits are based on reducing the risk of foodborne
illness due to Campylobacter jejuni/coli, Escherichia coli 0157:H7,
Listeria monocytogenes and Salmonella. Section IV concludes that these
four pathogens are the cause of 1.4 to 4.2 million cases of foodborne
illness per year. FSIS has estimated that 90 percent of these cases are
caused by contamination occurring at the manufacturing stage that can
be addressed by improved process control. This addressable foodborne
illness costs society from $0.99 to $3.69 billion, annually. The high
and low range occurs because of the current uncertainty in the
estimates of the number of cases of foodborne illness and death
attributable to the four pathogens. Being without the knowledge to
predict the effectiveness of the requirements in the rule to reduce
foodborne illness, the Department has calculated projected health
benefits for a range of effectiveness levels, where effectiveness
refers to the percentage of pathogens eliminated at the manufacturing
stage. The link between effectiveness and health benefits is the
proportionate reduction assumption which is explained in Section IV.
Because of the wide range in estimates for the cost of foodborne
illness, each effectiveness level will have a low and high estimate for
public health benefits. These estimates of public health benefits are
shown in Table 2, as the present value of a 20-year benefit stream.
The analysis assumes that benefits will begin to accrue in year
five. The five year lag leads to conservative benefit estimates since
the new HACCP-based inspection program will be fully implemented in 42
months, and benefits should accrue during those 42 months as well as in
the 1\1/2\ years that follow. Limiting the benefit estimates to four
pathogens also leads to conservative cost estimates. To the extent that
the proportionate reduction estimate may overestimate benefits, these
other factors provide conservative balance.
Net benefits exist for every cost and benefit combination
illustrated in Table 2 except for the case of 10 percent effectiveness
using the low benefit estimate. If the low benefit estimate is correct,
the new HACCP-based regulatory program would have to reduce pathogens
by 14 to 17 percent to cover the projected 20-year industry costs of
$968 to $1,156 million. For the high benefit estimate net benefits
begin to occur at an effectiveness level of 4 to 5 percent.
The costs summarized in Tables 1 and 2 have not been reduced to
account for firms that already have existing HACCP programs. FSIS does
not have a good estimate of the number of such firms.
C. Impact on ``Smaller'' Businesses
The final rule provides regulatory flexibility for smaller firms
consistent with the Regulatory Flexibility Act. For the slaughter
facilities, the generic E. coli sampling requirements vary depending on
the number of birds or animals slaughtered annually. This will
significantly reduce the microbial
[[Page 38957]]
testing costs for smaller establishments which, under the proposed
rule, would have been required to test every species or kind they
slaughter every day on which slaughter of that species or kind occurs.
Under the final rule, the impact on smaller establishments is mitigated
by the change to base generic E. coli sampling requirements on annual
production and by a change to no longer require that every species or
kind be sampled. The costs to small establishments are also reduced
because the proposed carcass cooling and antimicrobial near term
requirements have been eliminated from the final rule and training
requirements are more flexible. The requirement to sample each variety
of raw ground product, which caused a heavier burden on small
establishments, has also been eliminated.
The regulatory burden on small establishments is eased by the
provisions which extend the time small establishments have to meet the
HACCP system requirements. The detailed cost analysis in Section V
outlines the methodology used in developing cost estimates and varying
regulatory requirements for the purpose of regulatory flexibility for
small establishments.
D. Effect on Retail Price
The preliminary analysis included an estimate that the total four-
year implementation costs represented only $0.0024 per pound of fresh
meat and poultry. This type of estimate helps put overall cost figures
into perspective in terms of the potential increase in food prices. A
large number of smaller processors responded very emotionally to the
low figure of $0.0024 per pound on the basis that the lack of economies
of scale in their businesses means their potential unit cost increases
would be far higher. This ``cost-per-pound'' analysis was not meant to
imply that the cost impact on all business would be the same. In a
competitive industry, the impact on overall retail price is, however,
an important indicator of net societal benefits. The four-year
implementation costs for the final rule represent $0.0011 to $0.0013
per pound based on 1993 production of 67.15 billion pounds (66.4
billion pounds federally inspected and 748 million state inspected) of
meat and poultry on a carcass weight basis. The annual recurring cost
of $99.6 to $119.8 million represents $0.0015 to $0.0018 per pound
based on 1993 production.
E. Impact on International Trade
The final rule will have an impact on countries and the
establishments in those countries that export meat and poultry products
to the United States. The inspection statutes require that imported
product be produced under an inspection system that is equivalent to
the U.S. inspection system. The equivalence of a country's system must
be established by the United States before product can be exported to
the United States. The notion of equivalence has been clarified under
the World Trade Organization (WTO) Agreement on Sanitary and
Phytosanitary measures. Under the WTO, all members have an obligation
to apply the principle of equivalence on importing countries.
Equivalence determinations are based on scientific evidence and risk
assessment methodologies.
In light of the WTO emphasis on the use of science to determine
equivalence, a number of countries are moving toward implementation of
HACCP systems. The preliminary analysis noted that a large portion of
the eligible exporting establishments are in countries that are
themselves in the process of implementing HACCP and complying with
their own country's HACCP requirements may achieve equivalence with the
requirements of this rule.
As of January 1, 1995 there were 1,395 establishments in 36
different countries certified to export meat or poultry products to the
United States. Canada (599 establishments), Denmark (125
establishments), Australia (111 establishments) and New Zealand (94
establishments) accounted for two-thirds of the 1,395 establishments.
These four countries were the source of 85 percent of the 2.6 billion
pounds of product imported during 1994. These four countries are
currently developing HACCP systems for their respective inspection
programs.
Half (18) of the 36 countries have fewer than 10 establishments
approved to export products to the U.S. These 18 countries represent a
total of 77 establishments, 5 percent of the total. Meeting the
equivalency requirements may present a problem for some of these
countries in the near term. Their inspection programs will have to meet
equivalency requirements for HACCP according to the implementation
schedule for domestic establishments, i.e., 18 months for large
establishments, 30 months for small establishments and 42 months for
very small establishments. This schedule should lessen the burden on
smaller establishments.
There are other factors that will affect the burden on foreign
establishments. As HACCP becomes the international norm, these
establishments will be required to implement changes to meet the
requirements of other countries implementing HACCP. Thus, their costs
may not be solely associated with U.S. requirements. Establishing
impact is further complicated because the U.S. requirements apply only
when they are preparing product that is to be exported to the U.S. This
product may represent only a small portion of total establishment
production.
Upon implementation of these regulations, FSIS will review other
countries' meat and poultry systems to ensure that exporting countries
have adopted comparable measures, which would entitle them to continue
exporting product to the United States. As other countries improve
their regulations by adopting provisions comparable to those contained
in this rule, it is expected that U.S. exports will similarly be
affected, i.e., the receiving countries will be closely reviewing
domestic exporting establishments to assure that they are meeting the
requirements of the importing country.
FSIS will continue to carry out its import inspection
responsibilities with a two-stage approach. The first stage is system
review, which consists of an evaluation of the laws, policies, and
administration of the inspection system in each eligible country. This
overall evaluation will include an assessment of the implementation of
HACCP supplemented by on-site reviews of individual establishments,
laboratories, and other facilities within the foreign system. The
``equivalency'' of foreign requirements will be determined at this
stage.
The second level of review involves port-of-entry inspection by
FSIS inspectors to verify the effectiveness of foreign inspection
systems. Using statistical sampling plans based on the foreign
establishment's history and the nature of the product, FSIS will
continue to give greater scrutiny to shipments posing the highest risk.
Products that do not meet U.S. requirements, which includes having been
produced under a HACCP or HACCP-equivalent system, will be refused
entry. FSIS has concluded that requiring HACCP systems in combination
with the two-stage inspection approach will better ensure the safety of
imported meat and poultry products.
All countries exporting raw products to the U.S. must develop and
implement performance standards that are equivalent to the pathogen
reduction performance standards for Salmonella. They must also be able
to demonstrate that they have systems in place to assure
[[Page 38958]]
compliance with the standards. As with any other type of standard, FSIS
could choose to test imported product for Salmonella at port-of-entry
to verify the effectiveness of the foreign inspection system.
With respect to the specific requirements for sampling generic E.
coli to validate control of slaughter and sanitary dressing procedures,
it will be necessary for all foreign countries to demonstrate that they
have an equivalent procedure to verify that they are controlling their
slaughter and sanitary dressing processes.
There were several comments related to trade issues. Most of the
comments concerning the impact on exports dealt with the proposed
requirement for antimicrobial treatment of U.S. product. That proposed
requirement raised particular concerns because the European Union
member states and Canada restrict the use of certain antimicrobials on
meat and poultry carcasses. The concerns raised in the comments are no
longer an issue because the final rule does not require the use of
antimicrobials. The final rule will affect exports only if a company
has difficulty meeting the microbial performance criteria without using
an antimicrobial. One option discussed in the proposed rule was that
hot water would be considered to be an acceptable antimicrobial
treatment, and that would be acceptable to Canada and the members of
the European Union. The public comments also indicated that Trisodium
Phosphate (TSP) is approved for use in Canada and the United Kingdom
and is being considered by the European Union, Australia, and New
Zealand.
Comments related to imports were concerned about the procedures
FSIS would use to determine equivalence with the new U.S. requirements.
As a condition of the NAFTA Treaty and the GATT Treaty, the United
States has agreed to allow imports from countries that have systems of
inspection equivalent to that of the United States. FSIS is considering
alternative methods for determining that a foreign country's system of
inspection can assure that the establishments within that system are
using a process control system equivalent to the HACCP-based inspection
system outlined in the final rule.
F. Impact on Agency Costs
Implementation of this rule will lead to both one-time nonrecurring
costs and recurring costs for FSIS. There are three categories of one-
time nonrecurring costs: (1) Training, (2) in-establishment
demonstration projects, and (3) laboratory renovation. In order to
implement the rule, FSIS will provide training to in-establishment
personnel in two segments. The first training segment will cover issues
related to sanitation standard operating procedures and generic E. coli
sampling and testing requirements. The estimated costs for this
activity is $3.6 million in the first year of implementation. The
second training segment will cover issues related to the implementation
of HACCP and is estimated the cost $3.6 million spread over the second
and third year of implementation. FSIS will utilize the train-the-
trainer approach to minimize the costs of these initiatives. FSIS is
also committed to working with States and industry to sponsor HACCP
demonstration projects for small businesses. Pursuant to implementation
of the HACCP rule, microbiological sampling and testing will increase
dramatically. In the period from 1990 to 1995, FSIS averaged
approximately 33,000 analyses for microbiology per year. This is
estimated to increase to 125,000 analyses per year after HACCP
implementation. In order to accommodate this increase, FSIS will
renovate its field laboratory facilities to expand their capacity,
improve ability to test for a broader range of pathogens, and purchase
new equipment. FSIS estimates that the planned renovation will cost
$1.5 million.
By implementing this rule, FSIS will incur recurring costs
associated with increased microbiological testing and upgraded
inspector salaries. FSIS estimates that microtesting costs will
increase approximately $3.0 million annually. Of this amount $2.0
million is needed for equipment, supplies, and shipping costs to
conduct Salmonella testing, $0.5 million for microtesting conducted to
verify HACCP systems, and $0.5 million for personnel necessary to
handle the increased workload. Under HACCP-based inspection, FSIS
personnel will be required to assume greater responsbility for more
complex food inspection tasks. Slaughter inspectors will be required to
perform health and safety tasks, such as taking microbiological
samples, and verifying HACCP systems. Processing inspectors' roles will
take them out of the establishment and put them into retail and market
place settings to take microbiological samples, and to ensure meat and
poultry products are handled in a manner to that minimizes the growth
of pathogenic organisms. FSIS estimates that compensating inspectors
for assuming more complex food safety tasks will cost $1.6 million per
year.
G. Impact on State Programs
Comments stated that FSIS failed to adequately consider the cost of
the changes to State programs and that FSIS was increasing the resource
demands for State programs without providing adequate funding. The
preliminary analysis did not address the impact on State programs.
However, FSIS recognizes that the 26 States operating their own meat
and poultry inspection programs will likely have to substantially
modify their programs after the HACCP/Pathogen Reduction regulation is
finalized to remain ``at least equal to'' Federal inspection programs
as required by the FMIA and PPIA. During the regulation's
implementation period, FSIS will be using the Agency's State-Federal
Program staff to assist the States in bringing the necessary changes to
the State inspection programs. Although FSIS has requested some
additional funds to implement this rule, FSIS has also acknowledged
that implementation of this rule will require eliminating some tasks,
conducting other tasks differently and streamlining the organization in
order to free up resources to fully address the new requirements. FSIS
believes that the same type of restructuring or reprogramming will take
place within the State programs. This does guarantee, however, that all
States with inspection programs will be able to implement the necessary
program changes without additional funds. FSIS believes, however, that
with FSIS assistance and with the flexibility provided under the
``equal to'' provisions, most of the States should be able to modify
their programs with minimal additional funding. To the extent that
there are any additional costs, the State inspection programs are
eligible to receive up to 50 percent Federal matching funds.
H. Consumer Welfare Analysis
It is likely that at least some of the costs of the new HACCP-based
regulatory program will be passed on to consumers in the form of higher
prices. Even if costs are fully reflected in retail prices, the impact
on consumers and consumption will be small. Retail costs are not
expected to increase more than 0.02 percent. Retail demand for meat and
poultry is inelastic. A likely range is -0.25 to -0.75. This suggests
changes in quantity demanded of less than 0.02 percent. Given that
annual per capita meat and poultry consumption is about 211 pounds,
retail weight, the impact on individual consumption will be less than
\1/10\th of a pound per year. In aggregate, with a high impact
[[Page 38959]]
scenario, consumption would decrease by about 50 million pounds. These
impacts may be overstated if meat and poultry producers pass some costs
back to livestock and poultry producers. Improved consumer confidence
in the safety of meat and poultry could offset price driven decreases
in consumption.
IV. Analysis of Public Health Benefits
A. Introduction
This section addresses the methodology used to develop the
estimates for public health benefits that, for the purpose of this
final Regulatory Impact Assessment, have been defined as the reduction
in the cost of foodborne illness attributable to pathogens that
contaminate meat and poultry products at the manufacturing stage. This
section is organized around the Agency's responses to the public
comments related to benefits. The first part of this section addresses
the general comments related to risk assessment. The Agency has
responded to these general requirements by providing an overall summary
of the current state-of-the-art with respect to risk assessment for
foodborne pathogens. The second part of the discussion (see subsection
titled ``Analysis of Comments on Public Health Benefits'') addresses
the more specific comments on the methodology used to estimate benefits
in the preliminary analysis.
Several comments suggested that FSIS has not conducted an adequate
risk assessment and/or should conduct a thorough risk assessment before
proceeding with the current rulemaking. More focused comments assert
that the relationship between pathogen reduction at the manufacturing
stage and foodborne illness reduction is unknown. Those comments
suggest that establishing that relationship requires a quantitative
risk assessment, i.e., an estimate of the probability of adverse health
effects (foodborne illness) given a particular level of a hazard
(pathogens at manufacturing stage).
The preliminary analysis and this final RIA recognize that the
relationship is unknown and acknowledge that there are significant data
gaps regarding both likelihood and magnitude of illness and numbers of
foodborne pathogens. These data gaps mean that multiple assumptions
must be made in order to calculate the probabilities of risk, and FSIS
is concerned with this tremendous uncertainty. However, the agency is
developing quantitative assessments and believes that these will become
the basis on which to make future regulatory decisions. In this
rulemaking, FSIS estimates of the risk of foodborne disease linked to
specific pathogens are based upon the best judgement of nationally
recognized experts in infectious disease, epidemiology, microbiology,
and veterinary medicine. FSIS is also relying on a qualitative
estimation of risk as expressed in publications and summary reports
from the CDC, other public health agencies, and special panels, such as
the National Advisory Committee on Microbiological Criteria in Foods
and those established by the NAS. Based on this sizable body of
information and scientific judgement, FSIS is proceeding to develop
benefit estimates using the assumption that a reduction in pathogens
leads to a proportionate reduction in illness and death. The benefits
analysis could have used a more conservative relationship estimate,
e.g., a reduction in pathogens leads to a reduction in illness that is
less than proportional. However, given the current level of knowledge,
FSIS views the proportional assumption as most appropriate at present.
The Department has initiatives in place that will begin to relate
pathogen levels at inspected establishments to incidence of human
illness and support quantitative risk assessment (see Section IV-D on
FSIS Data Initiatives). The present paucity of data to support a risk
model for the major foodborne pathogens causing human disease limits
the usefulness of quantitative risk assessment in the regulatory arena
of meat and poultry inspection. It is unlikely that any single
numerical constant will adequately describe the dose-response
relationships for all pathogens associated with all of the products
that FSIS regulates, given the complexity of possible interactions of
factors associated with the host, the pathogenic strain, the diet, and
the environment (CAST, 1994).
The Federal Crop Insurance Reform and Department of Agriculture
Reorganization Act of 1994 (P.L. 103-354) now requires that for each
proposed major regulation (i.e. economic effects of at least $100
million a year and effects on human health, safety, or the environment)
the Department publish an analysis of the risks addressed by the
regulation. While this statute does not apply to this final rule, FSIS
is providing a qualitative estimation of risk (Tables 4 and 5) and a
recommendation to manage risk using HACCP in meat and poultry
inspection programs. Concurrently, scientists from FSIS and USDA's
Agricultural Research Service (ARS), Economic Research Service (ERS),
and modelers from academia and industry continue to develop risk models
which blend failure analysis, predictive microbiology, and other models
into the framework described by the NAS (NRC, 1983). FSIS believes this
approach is flexible and responsive to new data necessary to fully
document risks of foodborne diseases.
B. FSIS Risk Assessment
Following the publication of the 1985 National Academy of Sciences
(NAS) study on the scientific basis for meat and poultry inspection,
FSIS requested that the National Research Council of NAS conduct a
follow-up study that included the objective of developing a risk
assessment model for the poultry production system. The subsequent
report, ``Poultry Inspection: The Basis for a Risk-Assessment
Approach'' was published by the National Academy Press in 1987. The
1987 study concluded that the present system of inspection provides
little opportunity to detect or control the most significant health
risks presented by microbial agents that are pathogenic to humans. The
study also concluded that current databases can serve as the basis for
a comprehensive, quantitative risk assessment only for certain well-
characterized chemical residues.
The committee conducting the study also concluded that their report
did constitute a qualitative risk assessment that could be useful for
many purposes, including the evaluation of inspection strategies. That
assessment found: ``There is evidence linking disease in humans to the
presence of pathogens on chickens. For example, epidemiological studies
indicate that approximately 48% of Campylobacter infections are
attributable to chicken. Data also suggest that chicken is probably an
important source of salmonellosis in the United States.'' Based on
these and other findings, the committee recommended that FSIS ``modify
the existing system so that it more directly addresses public health
concerns.'' FSIS believes that the implementation of HACCP programs at
slaughter for meat and poultry is such a ``modification'' of the food
safety system which will address human health hazards, particularly
foodborne diseases.
C. Risk Assessment Framework
The National Research Council (1983) presented a framework for risk
assessment that has become a standard paradigm to organize risk
assessments for chemical and microbial hazards. The framework,
consisting of hazard identification, dose-response assessment, exposure
assessment, and risk characterization, is flexible and can accommodate
many different modeling strategies. The major distinction
[[Page 38960]]
between foodborne microbial risk assessments and chemical risk
assessments may be the additional uncertainties of microbial growth and
survival in food prior to consumption. Survival of pathogens present in
a raw food and after cooking can be modeled using predictive
microbiology methods. These models can also address the growth of
pathogens with time and temperature abuse of raw and cooked foods.
One of the first U.S. publications on the application of predictive
microbiology to microbial risk assessment (Buchanan & Whiting, 1996)
included estimations of risk of salmonellosis for several ``what-if
scenarios'' as examples of potential time and temperature abuses of
partially cooked food. The predictive microbiology model was linked to
a published dose-response model for salmonellosis (Haas, 1983) to
calculate a risk estimate. The dose-response model was developed by
empirically fitting data from human feeding studies conducted at high-
dose challenges with a number of pathogenic strains of Salmonella to
the ``beta poisson'' model (Haas, 1983). The authors generated risk
estimates for selected cooking and abuse scenarios, but recognized that
the risk of illness is zero when the pathogen is not present in the
sample even with unsafe food handling. HACCP programs at slaughter are
expected to affect pathogen presence and levels before potential time
and temperature abuses can occur. Therefore, changes at slaughter, in
the duration of cooking, and final storage conditions of the food exert
a tremendous impact upon the model outcomes.
An unpublished draft risk model is in development as a research
endeavor by Agriculture and Agri-Food Canada and Health Canada. A
variety of modeling approaches were organized within the 1983 NRC
framework to estimate risk of human illness from E. coli 0157:H7 in
ground beef. The draft risk model includes many stochastic variables to
account for the variability and uncertainty associated with the inputs
and assumptions of the model. The authors are developing the model to
identify current limitations to the construction of quantitative models
which accurately describe the risk of foodborne disease along the farm
to fork continuum.
These recent quantitative risk assessment efforts are an
encouraging beginning and serve to illustrate the tremendous
uncertainties created by insufficient data describing processes
throughout the farm to table continuum that contribute to risk.
Additional uncertainties surround assumptions based on epidemiologic
data for human illness. For example, recent data in the U.S. indicates
a growing number of outbreaks of E. coli 0157:H7 disease linked to
sources other than ground beef. The ecology of the organism on the
farm, in the bovine gastrointestinal tract, and in irrigation,
recreational, and drinking waters is largely unknown. Additionally, the
primary sources of E. coli 0157:H7 causing sporadic disease may remain
undercooked hamburger and may differ from vehicles causing outbreaks,
as has been documented for Campylobacter (CDC, 1988). Outbreaks of
campylobacteriosis have been caused primarily by unpasteurized milk and
contaminated water, yet the overwhelming majority of infections are
sporadic and have been linked to undercooked chicken. Control
strategies to reduce both outbreak and sporadic case numbers for both
of these pathogens may require greater understanding of vehicles of
disease and more information than is currently available.
FSIS concludes that risk models for foodborne illnesses are
necessarily based largely on assumptions because scientific data
describing key foodborne disease processes have not been developed. The
models are extremely useful to identify basic research needs that might
reduce the uncertainty associated with the inputs and assumptions of
the models. The agency is proposing initiatives to generate data which
may reduce uncertainties associated with modeling the risk of foodborne
diseases. However, application of microbial risk assessment models to
regulatory decision-making appears premature at this time. The
following is a summary of the availability and limitations of data
supporting risk assessment for foodborne pathogens:
1. Hazard Identification
The Agency selected from the pathogens listed in Tables 4 and 5 the
three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli 0157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes for consideration in risk assessment. FSIS
believes that these four pathogens may contaminate meat and poultry
food vehicles at slaughter and can be reduced through improved process
control in the manufacturing sector. Available data on estimated human
disease incidence are summarized in Table 4. Data on human disease
attributable to proven as well as epidemiologically linked pathogens
and food vehicles are presented in Table 5. Additional and more precise
information for this section regarding estimated national disease
incidence and disease severity and duration is expected on these
pathogens from the sentinel site surveillance initiative.
2. Exposure Assessment
Rarely can actual exposure to a specific strain of foodborne
pathogen be quantified with certainty in foodborne disease outbreaks.
Microbes in food are known to be non-homogeneously distributed,
imposing additional uncertainty due to sampling error upon the
analytical variability of the methods for detection and quantification
of microbes in foods. The outbreak strain may or may not be detected in
the feces of diarrheal cases or in leftovers or companion samples from
suspected lots. The levels detected in leftovers or companion samples
from the same lot of food may or may not be representative of the
serving that was prepared and consumed since the microbial numbers vary
with time and temperature conditions and the initial microbial
populations. The amount of the serving consumed may not be known.
The FSIS baseline studies provide data on occurrence of pathogens
(likelihood) and levels (magnitude) in uncooked meat and poultry
products at slaughter and raw ground processing. Data for likelihood
and magnitude of pathogens in the distribution, preparation, and
consumption phases of the farm-to-fork continuum of food production are
sparse. Predictive microbiology models may be the most cost-effective
method to deduce possible exposure scenarios in meat and poultry beyond
the slaughter phase that may result in foodborne illness. The
likelihood that the selected scenarios of improper cooking and abuse
actually occur among U.S. consumers may not be measurable, but the
scenarios may be useful in modification of behaviors that pose
increased risk to consumers.
3. Dose-Response Assessment
The relationship between the dose of a pathogen and response in the
host, when known, can vary greatly for foodborne pathogens. Human
feeding studies with foodborne pathogens were largely conducted several
decades ago with small numbers of healthy adult males. One study
reported both ill and asymptomatic volunteers who had consumed up to
1,000,000,000 pathogenic Salmonella. Outbreak data for other Salmonella
serotypes in food vehicles suggest a range of infective doses from one
cell to 1,000,000,000,000 cells (Blaser & Newman, 1982). Fatty food
vehicles, including some meat and
[[Page 38961]]
poultry products, are thought to protect enteropathogens from stomach
acids and digestive enzymes that might otherwise reduce the dose to the
intestinal tract and reduce the likelihood of disease. The effects of
competition of the pathogen with the large indigenous microbial
populations in food (ICMSF, 1980) and in the human gastrointestinal
tract (Rolfe, 1991) may reduce the likelihood and/or the severity of
foodborne disease.
Even carefully controlled volunteer feeding experiments at doses up
to one billion organisms per volunteer have shown variability in the
infectious dose of one pathogen for individuals within a group of
seemingly healthy, young adults. Extrapolation of empirical models of
effects at high doses to low doses typical of properly handled food may
or may not be appropriate. The dose-response curve for healthy adult
males may not be useful in estimating dose-response relationships for
the general population or sensitive sub-populations. The data available
from human feeding studies were generated from very few species and
strains of bacterial pathogens, excluding E. coli 0157:H7. Dose-
response modeling is crucial to microbial and chemical risk
assessments. FSIS believes that application of dose-response models in
food safety regulation requires careful examination of the validity of
the assumptions and inputs of the model and of the plausibility of the
model as a descriptor of foodborne disease processes.
4. Risk Characterization
The integration of exposure and dose-response models is expected in
risk characterization, along with sensitivity and uncertainty analyses
(Burmaster & Anderson, 1995) for the risk model. Perhaps of greater
significance than the numerical estimate of risk is the uncertainty
associated with the estimate. A fully developed risk characterization
would include risk estimates and sensitivity/uncertainty analyses for
alternative models and assumptions. FSIS is collaborating with
scientists in academia, the Agricultural Research Service, the Animal &
Plant Health Inspection Service, the Economic Research Service, and the
Office of Risk Assessment and Cost Benefit Analysis to develop and
validate a risk assessment model for a single pathogen in a single meat
product. This model may be modified for other specific pathogens of
concern. The expectation of a generic model for all foodborne disease
agents in all products does not appear promising based on differences
in pathogenesis of bacterial species and strains and in human
sensitivity and pathology.
FSIS continues to evaluate new information on foodborne pathogens
and on risk assessment methods and tools in accordance with the FSIS
public health mission. The NAS Report, the CAST Report and the 1995
Conference recognize HACCP as a system to reduce the likelihood of
foodborne illness. The CAST Task Force also concluded that ``the
efficacy of a HACCP system depends on the rigor and consistency with
which it is designed and implemented and the use of (a) critical
control point(s) that will control pathogens.''
D. FSIS Data Initiatives
The 1994 report, ``Foodborne Pathogens: Risks and Consequences,
CAST Task Force Report No. 122, September 1994'' concluded that ``a
comprehensive system of assessing the risks of human illness from
microbial pathogens in the food supply has yet to be devised.'' They
cited the limitations of the current food safety information database
and the difficulty in accumulating dose response and minimum infective
dose data. A recent multidisciplinary conference, ``Tracking Foodborne
Pathogens from Farm-to-Table, Data Needs to Evaluate Control Options'',
carefully reviewed current databases and confirmed limitations outlined
in the CAST Task Force report.
FSIS has established initiatives to improve the quality and
quantity of data in two major areas. First, FSIS is working with the
Food and Drug Administration (FDA) and the Centers for Disease Control
and Prevention (CDC) to establish an active sentinel site surveillance
system for the major causes of foodborne illness. This project is
designed to accumulate data on the incidence of foodborne illness by
pathogen and by food.
Second, the Agency has been developing baseline data for pathogen
levels on major food animal species at the time of slaughter. The
baseline data will allow the Agency to detect changes in the overall
nation-wide pathogen levels. The National Baseline program was
initiated in 1992 to provide information on the type and level of
microbiological contamination on raw products under Federal inspection.
Each sample collected is analyzed for nine microorganisms or groups of
organisms. Microbiological baseline data are now available for steers
and heifers, cows and bulls, and broiler chickens.
If sufficient data on both pathogen levels and foodborne disease
epidemiology result from current and future initiatives, FSIS should be
able to develop models showing how these two variables are related for
different pathogens. These models should then permit/facilitate a
quantitative estimate of risk. Such data are essential for FSIS to
evaluate the effect of control measures on both pathogens levels and on
foodborne illness.
E. ARS Food Safety Research Program
The Agricultural Research Service (ARS) administers a food safety
research program that is currently funded at approximately $45 million
per year. This program addresses problems in four different areas;
pathogen reduction, mycotoxins, residues, and natural toxins. The
reduction of microbial pathogens in food products of animal origin is
the most pressing food safety problem today. Consequently, the pathogen
reduction component is the largest of the four areas and is currently
funded at $18.2 million annually. The ARS research in pathogen
reduction addresses both preharvest and animal production, and post
harvest problem areas, with approximately equal funding for each.
Ongoing ARS research will help FSIS improve its capability for
performing quantitative risk assessment in the area of foodborne
pathogens or improve the ability to predict the effectiveness of new
pathogen reduction technologies. Ongoing projects include the modeling
of bacterial growth or thermal death times which will help set
standards for meat and poultry products. Ongoing projects will also
provide new laboratory screening or confirmatory methods. Other
projects provide and/or evaluate technology and management methods
which can help producers achieve lower contamination levels in animals
presented for slaughter, such as vaccines or competitive bacterial
cultures to prevent pathogens in live animals. There are also
technology and management methods for use in slaughter and processing
establishments, such as, organic acids for use in carcass sanitation,
improvements to the feather picking operation for poultry, washing of
trailers to reduce microbiological contamination, and establishment of
guidelines on the microbiological safety of recycling cooling solutions
for ready-to-cook meat and poultry products. In many cases the research
may provide the scientific basis for developing and improving
technology, for example, the nature of bacterial attachment to various
meat surfaces.
FSIS can and does forward very specific research requests to ARS.
In preparation for this final rule, FSIS requested that ARS compare the
results
[[Page 38962]]
from different microbial sample collection techniques, sponging versus
excision at one versus three carcass sites. These studies are currently
being conducted on both cow/bull and market hog carcasses. There are
other specific ARS projects that will help provide the scientific basis
for HACCP through risk assessment, predictive microbiology, and
pathogen reduction interventions for several different bacterial
pathogens which must be controlled to assure the safety of meat and
poultry.
These projects include: (1) Development of models to predict the
growth rates, survival times, and thermal death rates for microbial
pathogens potentially present in foods, including meat and meat
products. (Microbiological modeling is time consuming and expensive
because it requires that the data be quantified, that is, that numbers
of bacteria are obtained, rather just the knowledge of the presence or
absence of a pathogen under the conditions of the test.) The
microorganisms being studied include E. coli O157:H7, Listeria
monocytogenes, and Salmonella. These models are written into personal
computer software that gives FSIS a readily useable tool to help
evaluate proposed meat processes and assess out-of-process events.
Refining predictive models has the goal of linking an entire process
from raw ingredients to distribution of finished product. A specific
project is to model the survival of E. coli O157:H7 during the
manufacture of uncooked, fermented meat products. Using the information
obtained, ARS will closely collaborate with other USDA agencies to
develop strategies for risk reduction using the various processing
techniques, and to create risk assessment models.
(2) Modeling studies to predict the thermal inactivation of spore-
forming and non-spore-forming bacterial pathogens of both cooked and
ready-to-eat products. These studies will be extended to the cooling of
these products to ensure that there is no potential for growth of
Clostridium botulinum and C. perfringens.
(3) Determination of the long-term effects (21 days of storage at
refrigerated temperatures) of organic acid treatment of red meat on
some key pathogens (E. coli O157:H7, Listeria, and Clostridium), as
well as on spoilage bacteria (mesophilic aerobes, lactic acid bacteria,
and pseudomonads).
(4) Delineation of the parameters affecting the antibacterial
activity of organic acids. These include tissue type (pre-rigor, post-
rigor, frozen post rigor), inoculum type (pure culture or inoculated
feces), inoculum level and the temperature of spray wash at meat
surface. These results should clarify inconsistent reports on
antibacterial activity of organic acids and also define optimum
conditions to maximize the antibacterial activity of organic acids.
(5) The correlation of the Campylobacter levels in broilers from
the chill tank with their Campylobacter levels during production.
F. Analysis of Comments on Public Health Benefits
There were many comments on the methodology used to estimate public
health benefits in the preliminary analysis. This methodology used a
series of estimates or assumptions based on incomplete data related to
the six following areas:
Incidence of foodborne illness
Cost of foodborne illness
Percentage of foodborne illness and cost of foodborne
illness attributable to meat and poultry products
Pathogens addressed by the rule
Effectiveness of rule in reducing pathogens
Estimated reduction in cost of foodborne illness related
to reduction of pathogens
To facilitate discussion of the issues raised in comments, the
issues are addressed organized by these six areas.
1. Incidence of Foodborne Illness
Table 4 presents the most recent estimates on the incidence of
illness and death for selected pathogens along with the latest
estimates on the percentage of illness and death which is foodborne. As
discussed in the preliminary RIA, Table 4 includes the ``best
estimates'' when precise data are not available. Many of these
estimates are based on the landmark CDC study by Bennett, Holmberg,
Rogers, and Solomon, published in 1987, which used CDC surveillance and
outbreak data, published reports, and expert opinion to estimate the
overall incidence and case- fatality ratio for all infectious and
parasitic diseases. Estimates on the foodborne percentage of illness
and death for bacteria in Table 4 are all based on CDC data. The
resulting estimates for the number of foodborne cases and deaths are
presented in the second and third columns of Table 5.
The benefits for the preliminary analysis and this final RIA are
calculated for the three most common enteric pathogens of animal
origin: Campylobacter jejuni/coli, E. coli O157:H7, Salmonella and one
environmental pathogen Listeria monocytogenes. FSIS believes that these
four pathogens can be reduced through improved process control in the
manufacturing sector.
Although Clostridium perfringens and Staphylococcus aureus also
cause a significant number of foodborne illnesses, they are not
included in the benefits analysis because it is not clear that the
HACCP-based regulatory program, which focuses on federally inspected
processing, will significantly affect the incidence of disease caused
by these organisms. Staphylococcus aureus usually enters the food chain
through food handlers in restaurants and other commercial kitchens.
Although C. perfringens may enter the food chain through the slaughter
process, it is so ubiquitous in the environment that FSIS will not
assume that controls at slaughter will be effective against this
pathogen.
One commenter questioned why the Agency has not addressed the
public health problem of toxoplasmosis given the Table 5 estimate of
$2.7 billion in annual costs. FSIS believes that while process control
may help decrease the spread of cysts during boning and cutting
operations, most of the Toxoplasma gondi cysts are internal to
infective muscle tissues and are not addressable by process control.
Therefore, FSIS is making the more conservative assumption to exclude
this pathogen in the benefits estimate of disease averted.
Many comments suggested that the large range in the illness
incidence estimates demonstrates that there are insufficient data on
which to base a new regulatory program. Historically, the lack of
quantitative data on benefits and specific health risks have meant that
health and safety regulations have required decisionmaking under
uncertainty and have required the decisionmaker to balance the need to
act with the need for additional or improved data. Compared to such
issues as whether a chemical is a potential human carcinogen or whether
low levels of air pollutants cause adverse health effects, the health
effects of enteric pathogens are relatively well documented. If the
pathogens enter the food supply, they do, under certain conditions,
cause foodborne illness. If their presence can be prevented, no amount
of temperature abuse, mishandling or undercooking can lead to foodborne
illness.
The Agency believes that the existing estimates on foodborne
illness are adequate to conclude that a substantial and intolerable
public health problem exists. Furthermore, existing estimates are
appropriate for developing estimates on the cost of foodborne illness
attributable to meat and poultry. The
[[Page 38963]]
Agency notes that similar estimates on the incidence of foodborne
illness have been published by scientists from ERS in peer-reviewed
journal articles (see footnotes to Table 5) and by the 1994 CAST Task
Force.
The above statement that Table 4 includes the most recent estimates
of the incidence of illness and death requires further explanation in
the case of Listeria monocytogenes. The estimates of 1,795-1,860 cases
of listeriosis and 445-510 deaths are the ones used in the latest cost
of illness study conducted by ERS. ERS is in the process of publishing
a comprehensive documentation for the estimates of cost of illness for
1993. In their draft document they acknowledge that the estimate for
listeriosis cases originates from an extrapolation to the U.S.
population of incidence data from a CDC-conducted surveillance study of
six geographic regions in 1986 and 1987 (Gellin et al. 1987). They also
note that (Tappero et al. 1995) found that the incidence of listeriosis
has decreased since the 1960's and that projections from the
surveillance data suggest that there were 1,092 listeriosis cases and
248 deaths in 1993. ERS did not modify their cost of illness estimates
because Tappero et al., was published after their analysis was
concluded.
FSIS considered modifying the cost of illness estimates for this
final analysis but decided to use the estimates in Tables 4 and 5
because (1) They are the figures that will appear in the upcoming ERS
publication and, (2) updating the listeriosis estimates would have
minimal impact on the overall cost of illness estimates. Considering
the overall range and uncertainties involved in the cost of illness
estimates, the change in listeriosis estimates has negligible impact on
the regulatory analysis information conveyed through the potential
benefits estimate.
The Agency also recognizes that in using the 1993 estimates for
incidence of foodborne illness, the benefits analysis has not accounted
for possible reductions in foodborne illness attributable to the rule
that mandated safe handling statements on labeling of raw meat and
poultry products. The rule mandating safe handling instructions became
effective on May 27, 1994. Thus, it can be argued that the incidence of
foodborne illness for 1994 through the present should reflect the
effectiveness of the 1994 labeling requirement in reducing the
incidence of illness.
FSIS is not aware of any quantitative evaluation of the
effectiveness of safe handling labeling. Two recent surveys indicate a
high level of awareness, but these surveys do not contain findings that
can be translated into changes in consumer behavior. A recent
Associated Press poll found that 9 in 10 Americans say they follow the
safe-handling instructions. This poll, conducted in April 1996,
included 1,019 randomly selected adults. This was a telephone survey
conducted by ICR Survey Research Group. A November 1995 survey
conducted by Wegman Food Markets in Buffalo, Rochester, and Syracuse
found that 67.9 percent of respondents indicated they had read the safe
handling information. The Wegman's survey found that most household
meat preparers rely on color of meat or clarity of juices rather than
temperature to determine when meat has been cooked thoroughly.
In this analysis, FSIS has not attempted to adjust the 1993
baseline to account for safe handling labeling. The potential effect of
the 1994 regulation is one of many factors that could be affecting the
current incidence or cost of illness. A May 1996 GAO study on foodborne
illness notes that food safety and public health officials believe that
the risk of foodborne illness is increasing. If they are correct, the
1994 labeling rule may be slowing the growth rather than reducing the
absolute level.
There are many other factors that could have been incorporated into
the baseline for the analysis such as population growth and increases
in the cost of medical care. FSIS believes that attempts to adjust the
cost of illness baseline to account for factors such as inflation,
possible increases in foodborne illness due to behavior change or
population increases, and possible decreases due to inventions such as
safe handling labels are more likely to be misleading than informative
given the level of uncertainly and wide range in existing estimates.
2. Cost of Foodborne Illness
The fourth column of Table 5 shows that the 1993 estimated cost of
foodborne illness by pathogen or parasite was between $5.6 and $9.4
billion. These cost of illness estimates have been developed by ERS in
conjunction with CDC over the past 15 years. As indicated in footnotes
to Table 5, the results of that work have been frequently published in
peer-reviewed journals.
There were only a few public comments on the proposed rule which
addressed the methodology used for estimating the cost of foodborne
illness. Some comments argued that the public health benefit estimates
are low because of the low value-of-life factor used in the estimates
for the cost of foodborne illness.
ERS intentionally used a conservative method to estimate the value
of a statistical life (VOSL) acknowledging the controversy over valuing
lives. ERS used Landefeld and Seskin's VOSL estimates and recognizes
that the cost of illness estimates would be substantially higher if
they used alternative methods. For example, Viscusi (1993) summarized
the results of 24 principal labor market studies and found that the
majority of the VOSL estimates lie between $3 million and $7 million
per life. A survey of the wage-risk premium literature on the
willingness to pay to prevent death concluded that reasonably
consistent estimates of the value of a statistical life range from $1.6
million to $6.5 million dollars (1986 dollars) (Fisher et al. 1989).
Updated to 1993 dollars using the change in average weekly earnings,
Viscusi's range becomes $3.2 million to $7.6 million per VOSL and
Fisher's range becomes $2.0 million to $10.4 million dollars for each
statistical-life lost. Viscusi and the Fisher estimates are greater
than the highest Landefeld-Seskin (LS) VOSL estimate of $1,584,605 in
1993 dollars (estimate for a 22 year old).
Table 4.--Sources of Data for Selected Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Pathogen Estimated number of number of Source(s) for case and death Percent Source
cases deaths estimates foodborne
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli.. 2,500,000 200-730 Tauxe............................... 55-70 Tauxe et al.
Clostridium perfringens....... 10,000 100 Bennett et al....................... 100 Bennett et al.
Escherichia coli O157:H7...... 10,000-20,000 200-500 AGA Conference...................... 80 AGA Conf./CDC.
Listeria monocytogenes........ 1,795-1,860 445-510 Roberts and Pinner.................. 85-95 Schuchat.
[[Page 38964]]
Salmonella.................... 800,000-4,000,000 800-4,000 Helmick et al./Bennett et al. 87-96 Bennett et al./Tauxe & Blake.
Staphylococcus aureus......... 8,900,000 7,120 Bennett et al....................... 17 Bennett et al
Parasite:
Toxoplasma gondii............. 4,111 82 Roberts et al....................... 50 Roberts et al.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources: American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July 11-13, 1994. Bennett, J.V., S.D.
Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden
of Unnecessary Illness. Oxford University Press, New York. Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious
Diarrheas.'' In: Everheart, JE, ed. Digestive Diseases in the United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94-1447, pp.
85-123, Wash, DC: USGPO.
Roberts, T., K.D. Murrell, and S. Marks. 1994. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423.
Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, September 29, 1994.
Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins,
ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9-19. Tauxe, R.V. and P.A. Blake, 1992. ``Salmonellosis'' Chap. 12.
In: Public Health & Preventative Medicine, 13th ed. (Eds: Last JM: Wallace RB; Barrett-Conner E) Appleton & Lange, Norwalk, Connecticut, 266-268.
Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth. 1988. ``Campylobacter Isolates in the United States, 1982-1986,'' Morbidity and
Mortality Weekly Report, vol 31, no. SS-2: pages 1-14.
Table 5.--Medical Costs and Productivity Losses Estimated for Selected Foodborne Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foodborne illness Percent Meat/poultry related Total
------------------------------ Foodborne from ------------------------------ costs *
Pathogen * costs meat/ meat/
Est. No. of Est. No. (bil $) poultry Est. No. of Est. No. poultry
cases deaths (%) cases deaths (bil $)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli............................. 1,375,000-1,75
0,000 110-511 0.6-1.0 75 1,031,250-1,31
2,500 83-383 0.5-0.8
Clostridium perfringens **............................... 10,000 100 0.1 50 5,000 50 0.1
Escherichia coli 0157:H7................................. 8,000-16,000 160-400 0.2-0.6 75 6,000-12,000 120-300 0.2-0.5
Listeria monocytogenes................................... 1,526-1,767 378-485 0.2-0.3 50 763-884 189-243 0.1-0.2
Salmonella............................................... 696,000-3,840,
000 696-3,840 0.6-3.5 50-75 348,000-2,880,
000 348-2,880 0.3-2.6
Staphylococcus aureus **................................. 1,513,000 1,210 1.2 50 756,500 605 0.6
------------------------------------------------------------------------------------------
Subtotal............................................. 3,603,526-7,13
0,767 2,654-6,546 2.9-6.7 N/A 2,147,513-4,96
6,884 1,395-4,461 1.8-4.8
------------------------------------------------------------------------------------------
Parasite:
Toxoplasma gondii........................................ 2,056 41 2.7 100 2,056 41 2.7
------------------------------------------------------------------------------------------
Total................................................ 3,605,582-7,13
2,823 2,695-6,587 5.6-9.4 N/A 2,149,569-4,96
8,940 1,436-4,502 4.5-7.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: ERS, 1993
* Column rounded to one decimal place.
** Roberts' rough approximation of costs in ``Human Illness Costs of Foodborne Bacteria'', Amer. J. of Agricultural Economics, vol. 71, no. 2 (May 1989)
pp. 468-474 were updated to 1993 dollars using the Consumer Price Index (all items, annual average). Cost estimates for other pathogens are more
detailed, see the following for a discussion of the methodology:
listeriosis--Roberts, Tanya and Robert Pinner, ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J.
Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137-149,
E. coli O157:H7--Roberts, T. and Marks, S., ``E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease,'' FoodReview, USDA/ERS, Sept-Dec 1993,
pp. 51-59.
salmonellosis--Roberts, Tanya, ``Salmonellosis Control: Estimated Economic Costs,'' Poultry Science. Vol. 67 (June 1988) pp. 936-943,
campylobacteriosis--Morrison, Rosanna Mentzer, Tanya Roberts, and Lawrence Witucki, ``Irradiation of U.S. Poultry--Benefits, Costs, and Export
Potential, FoodReview, Vol. 15, No. 3, October-December 1992, pp. 16-21, congenital toxoplasmosis--Roberts, T., K.D. Murrell, and S. Marks. 1944.
``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423; and Roberts, Tanya and J.K. Frenkel,
``Estimating Income Losses and Other Preventable Costs Caused by Congenital Toxoplasmosis in People in the United States,'' J. of the Amer. Veterinary
Medical Assoc., vol. 196, no. 2 (January 15, 1990) pages 249-256.
N/A indicates item is not-applicable.
ERS is currently working on a sensitivity analysis for their cost
of illness estimates for foodborne illness. The sensitivity analysis
replaces the LS VOSL estimates with estimates found in the literature
on wage-risk studies. Preliminary findings show that the estimates of
the total cost of foodborne illness will increase greatly when these
higher VOSL estimates are used.
FSIS considers that the existing conservative estimates are
appropriate considering the controversy and uncertainty. The
conservative estimates are more than sufficient to justify the
[[Page 38965]]
final rule implementing a new HACCP-based regulatory program for meat
and poultry. This final RIA uses the cost of illness estimates shown in
Table 5.
Another comment stated that the cost of illness estimates are low
because they do not account for increases in productivity. In response,
the Agency notes that ERS used Landefeld and Seskin's estimates for the
value of a statistical life, and those estimates do include an
estimated 1% annual increase in productivity.
One commenter suggested that a methodology based on earning power
may overestimate the value of life where many deaths from foodborne
illness are the very elderly, the immunocompromised and the terminally
ill. This commenter also noted that while all deaths are tragic, from a
strictly economic standpoint many of these tragic cases have little or
no productivity left and in fact are utilizing resources at the rate of
$3,000 to $12,000 or more dollars per month of maintenance.
The cost of illness methodology used by ERS does account for the
fact that older individuals have lower remaining earning power than
younger individuals. This difference was taken into account when
estimating the costs of lost productivity for salmonellosis patients.
Different Landefeld and Seskin estimates of the values of statistical
life were used for the different age categories. The methodology used
U.S. death certificate data to estimate that the average age for
patients who die from salmonellosis is over 65 years. The concept of a
statistical value of life accounts for the fact that older individuals
may continue to work or be retired or be patients under long term
health care.
3. Percentage of Foodborne Illness and Cost of Foodborne Illness
Attributable to Meat and Poultry
The fifth column of Table 5 includes estimates on the percentage of
foodborne illness attributable to meat and poultry products. A separate
estimate has been developed for each pathogen. These estimates are
based on outbreak data reported under the CDC Foodborne Disease
Outbreak Surveillance System and on data from community-based and other
epidemiologic studies. Major data sources are cited in the preamble to
the final rule. An assumption is made in this analysis that the source
of foodborne pathogens, i.e., meat and poultry versus dairy products,
seafood, vegetable, etc., has no effect on the cost of illness. The
Department is not aware of any data indicating that the severity of
foodborne illness cases varies by source of pathogens.
Comments noted that the Department had increased the percentage of
foodborne illness attributable to meat and poultry from the earlier
rulemaking for safe handling labels. One commenter stated that the
Department has not revealed any new information which would support
such an increase.
At this time, data on incidence of foodborne illnesses and the
percentage of cases attributable to different food items are limited.
Estimates by pathogen have been made by experts at CDC and USDA, based
on a variety of studies. However, these are, indeed, estimates: FSIS
does not have exact numbers. The estimates in the 1993 Federal Register
document were relatively crude, assuming that 100% of Campylobacter and
E. coli O157:H7 cases, 96% of Salmonella cases, and 85% of Listeria
cases were foodborne, and that, for all bacterial pathogens, a flat 50%
of foodborne cases were attributable to meat and poultry. The 1995
document looked at the numbers in a somewhat more sophisticated way,
evaluating each pathogen individually and, where appropriate, giving
ranges for, first, percentage of cases which were foodborne, and,
secondly, percentage of cases which were attributable to meat and
poultry. Nonetheless, when all of the various percentages are
multiplied out, estimates of total cases attributable to meat and
poultry were remarkably similar, as shown below in Table 6.
Table 6.--Percentage of Foodborne Illness Attributable to Meat and Poultry
----------------------------------------------------------------------------------------------------------------
Percentage Percentage
of total of total
cases cases
attributed attributed Estimated total Estimated total
Pathogen to meat and to meat and cases, 1993 cases, 1995
poultry a poultry,
1993 1995
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
Campylobacter............................... 50 41-53 1,050,000 1,031,250-1,312,500
Salmonella.................................. 48 43-72 921,600 348,000-2,880,000
E. coli O157:H7............................. 50 60 3,834-10,22 46,000-12,000
Listeria.................................... 43 43-48 649-672 763-884
----------------------------------------------------------------------------------------------------------------
a Reflects percentage of foodborne multiplied by percentage attributable to meat and poultry.
Most other comments related to the estimates on the percentage of
foodborne illness attributable to poultry. Comments questioned the high
incidence of poultry-related foodborne illness when even, as a
commenter asserted, public health authorities tell consumers that the
problem with poultry meat is not due to consumption because poultry is
cooked. Comments questioned whether cross-contamination in the kitchens
could possibly generate such high levels of foodborne illness. Related
comments suggested that if cross-contamination was such a serious
problem, the data would show more outbreaks and fewer single cases.
Other comments suggested that the cost of salmonellosis attributed to
poultry was high because of the high incidence of Salmonella
enteritidis in eggs and requested that the Agency exclude any foodborne
illness costs associated with eggs, because those issues are outside
the scope of this rulemaking. Another comment cited an Australian
finding that the Campylobacter strains that infect chickens are not the
strains that primarily infect humans.
The Department agrees that undercooked poultry is not a primary
cause of foodborne illness. The preamble to the proposal stated that
the majority of salmonellosis results from cross-contamination. The
best available estimates for foodborne illness do suggest that a high
incidence of illness is attributable to cross-contamination in
kitchens--both household kitchens and food-service establishments.
The comment suggesting that cross-contamination would have led to
more outbreaks makes sense, if the available estimates on incidence
were heavily
[[Page 38966]]
based on outbreak data. However, as mentioned in the proposal, it is
widely recognized that CDC outbreak data do not provide accurate
estimates of foodborne disease incidence. The outbreak data are more
useful in identifying factors that lead to illness and have been used
to estimate proportions of illness attributable to specific food
groups. They do not play a major role in the overall incidence
estimates. The existing incidence estimates are for total cases
including both individual cases and multiple cases. The methodology
used does not distinguish between outbreaks and single cases. Just as
there are unreported individual cases of foodborne illness, there are
unreported cases where entire households or portions of households
experience foodborne illness due to cross-contamination in household
kitchens. As discussed above, the estimates of foodborne illness were
derived from both CDC outbreak data and community-based epidemiologic
studies.
The outbreak data (two or more individuals ill from the same
source) are compiled by CDC from reports that are voluntarily submitted
from state and local health authorities. The laboratory reporting
system for Salmonella only captures information on those cases where a
patient sees a doctor, the doctor collects a stool culture and sends
the culture to a participating laboratory and the laboratory can
perform the specific diagnostic test. The estimates for overall disease
incidence are derived using both databases plus data collected from
population-based studies in specific geographic areas. The current
(initiative) collaborative surveillance project should improve the
estimates in the future.
The comment referring to the Australian finding is referring to an
article by Korolik, et al, published in the May 1995 issue of the
Journal of Clinical Microbiology, entitled, ``Differentiation of
Campylobacter jejuni and Campylobacter coli strains by Using
Restriction Endonuclease DNA Profiles and DNA Fragment Polymorphisms.''
The study was undertaken to determine if DNA fingerprinting
technologies could identify strains of Campylobacter in chickens that
cause disease in humans.
FSIS reviewed the article and concluded that the study did not
refute U.S. epidemiologic studies showing that approximately 50% of
human Campylobacter infections are due to poultry. To confirm FSIS's
interpretation of the study, a staff member contacted the author, Dr.
Victoria Korolik, in Australia. She confirmed that her study does not
shed doubt on the role of poultry in human Campylobacter infections.
4. Pathogens Addressed by the Rule
While the proposed rule indicated that HACCP systems will be
designed to control all public health hazards, the preliminary benefits
analysis assumed that the primary benefits will come from controlling
the three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli O157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes. Two other pathogens--Clostridium perfringens
and Staphylococcus aureus primarily become or create hazards in meat
and poultry products as prepared in restaurants, other commercial
kitchens, and in homes. Consequently, the proposed regulatory program,
which focuses on the manufacturing sector, will not significantly
affect the presence of these organisms on meat and poultry products.
The public comments did not address the assumption that the
proposed rule would have the most impact on the four pathogens
identified above and that benefits would be most appropriately
discussed in terms of reducing the level of these pathogens. This final
RIA will continue to assume that the HACCP-based regulatory program
will have the most impact on the four pathogens identified in the
preliminary analysis.
The preliminary benefits analysis also included an assumption
concerning the percentage of the four pathogens that contaminate the
meat and poultry supply at inspected establishments or grow from
contamination that occurs at inspected locations. Based on the expert
judgment of FSIS microbiologists, the preliminary benefit analysis
assumed that 90 percent of the four pathogens result from contamination
that occurs at inspected establishments.
The public comments did not directly address the estimate that
slaughter and processing establishments are the source of 90 percent of
enteric pathogen contamination. There were, however, a large number of
comments that cited studies or estimates that show or indicate that the
majority of foodborne illness can be attributed to improper cooking,
recontamination and other mishandling and abuse in the food service and
home environment. Many comments cited data presented in the 1994 CAST
Report which ``demonstrated'' that only 6.9 percent of outbreaks were
``attributable'' to the food processing establishments. Other comments
referred to ``a well-recognized fact that 97 percent of the problems
with foodborne illness occur outside the realm of state and federal
inspection.'' Other comments attributed the 97 percent figure to a
Special Report by the American Association of Meat Processors. These
types of comments were presented in a manner indicating that the
commenters believe that the data attributing ``cause'' to the food
service or home environment directly contradicts the Agency's estimate
that inspected establishments are the source of 90 percent of the four
pathogens addressed by this rule.
In response, the Agency points out that the studies cited by
commenters concluding that high percentages of foodborne illness are
attributable to factors such as temperature abuse and mishandling do
not conflict with either the assumption that slaughter and processing
establishments are the source of 90 percent of enteric pathogen
contamination or the assumption discussed later concerning the
effectiveness of HACCP in reducing that contamination. Occurrence of
foodborne disease is a multi-step process. The first, and critical,
step is the introduction of a pathogen into or onto the raw product. If
a pathogen is present, then subsequent temperature abuse or mishandling
may permit bacterial counts to increase to levels which increase the
likelihood that illness will occur; mishandling may result in cross-
contamination of other foods which are not cooked before being eaten;
or improper cooking may not kill all pathogenic bacteria present in the
product. In these instances, it may be said that the illness was
``caused'' by improper handling. However, disease would not have
occurred if the pathogen had not been present on the raw product in the
first place.
The CAST study included a table showing factors contributing to the
occurrence of 1,080 outbreaks occurring from 1973 to 1982. That table
consisted of data from the CDC national foodborne disease surveillance
system that was published in an article in the Journal of Food
Protection by Frank L. Bryan in 1988. The CAST study and journal
articles use terminology like ``factors that contribute'' and address
the location or type of employee/consumer where any mishandling or
mistreatment of food occurred. The focus of these studies is to enhance
our understanding of the sequences of events and behaviors that lead to
foodborne illness since behavioral modification for the food preparer
and consumer at the end of the food chain may have the greatest impact
on the incidence of foodborne disease. Many of the comments are written
in a manner that blurs the distinction
[[Page 38967]]
between factors in the kitchen that may permit an outbreak to occur
from slaughter-origin contamination and those that would have caused an
outbreak despite the absence of contamination of the raw ingredients.
The comments referring to the CAST study or directly to CDC
estimates have not interpreted the Foodborne Disease Outbreak
Surveillance Data correctly. The standard CDC foodborne disease
outbreak report form does not include a question about whether the food
processing industry was involved, and while many foodborne outbreaks
have a chain of causation, investigators may differ in their assessment
of the point or points in the chain to which primary responsibility for
occurrence of the outbreak should be assigned.
The Bryan article used for the CAST study had the following summary
concerning the role of food processing establishments: ``Many of the
animals that enter abattoirs are either infected or contaminated with
foodborne pathogens and further spread occurs during processing. Hence,
abattoirs and raw-product processing establishments must accept some of
the blame of spreading salmonellae and other pathogens to many
carcasses and pieces of meat. These products are major sources of
pathogens for food-service establishments and homes where further abuse
(e.g., inadequate cooking or cross contamination) leads to outbreaks of
foodborne illness.''
The comments have not provided any basis for changing the expert
judgment of FSIS microbiologists that inspected establishments are the
source of 90 percent of the four pathogens addressed by the final rule.
This final benefits analysis is based on this assumption.
5. Effectiveness of the Rule in Reducing Pathogens
In accordance with the assumption that meat and poultry
establishments are the source of 90 percent of the four pathogens
addressed by the rule, the preliminary analysis calculated the benefits
under a scenario where the proposed rule would eliminate essentially
100 percent of those pathogens that enter the meat and poultry supply
at inspected processing establishments. In other words, for the
preliminary analysis, FSIS calculated an estimate of maximum benefits
by assuming the rule would eliminate 100 percent of the 90 percent.
By assuming this scenario, FSIS was not predicting that it believed
that the rule would result in elimination of 100 percent of those
pathogens in the manufacturing sector. Rather, the Agency was
acknowledging that it has responsibility for having a food safety
objective that recognizes the scope of the problem and attempts to
reduce pathogens in that sector as much as possible, since without
pathogens, no amount of subsequent abuse would result in foodborne
illness.
By presenting a sensitivity analysis in the proposal, FSIS intended
to clarify that the benefit estimates were a maximum and not a
prediction of what is likely to happen. The distinction was unclear to
many commenters who expressed doubt that the proposed HACCP program
would result in a 90 percent reduction in pathogens. A large number of
comments on the potential effectiveness of HACCP programs contrasted
the FSIS estimates with those contained in the recent study by the
Institute of Food Science and Engineering, Texas A&M University, titled
``Reforming Meat and Poultry Inspection: Impacts of Policy Options,''
(hereafter referred to as the IFSE study). Both FSIS and IFSE estimates
are useful as assumptions rather than as quantitative predictions of
potential effectiveness of HACCP.
The ISFE study examined four policy options for addressing
pathogens in the meat and poultry supply. One option called for
mandatory HACCP for inspected slaughter and processing establishments
and estimated that mandatory HACCP in inspected establishments would
produce a 20 percent reduction in pathogens. The difference in the FSIS
and IFSE estimates is not based on data but on assumptions for
different ``HACCP'' scenarios.
The HACCP program scenario considered in the IFSE study did not
assume a mandatory pathogen reduction performance standard. Requiring
process control without a standard could lead to processes that are
well controlled at unacceptable pathogen levels. The Agency would agree
that such a situation would result in less pathogen reduction. FSIS
believes that a standard is necessary to encourage innovation and
provide the impetus for continuing improvement and increasing
effectiveness. In estimating effectiveness, the IFSE study noted that
``with experience and additional research, it is possible that higher
levels of reduction in pathogens could be achieved * * *''.
Another major difference between the two program scenarios is that
the IFSE program does not include a prerequisite requirement for SOP's.
SOP's could cover potential sources of enteric and environmental
pathogens that are not be covered under a HACCP plan. However, as
discussed in Section I, this analysis discusses benefits of SOP's in
terms of increased productivity for inspection resources and clarity of
responsibilities.
Several comments refer to the IFSE estimates as being more
objective or ``scientific'' than those in the Agency's analysis. The
IFSE authors characterize their own effectiveness estimates as ``the
consensus judgment of the task force'' or ``the most reasonable
expectation.'' The IFSE estimates are judgments, as are the Agency's
estimates.
A general comment related to the effectiveness issue stated that
while HACCP remains an interesting theoretical concept, it is still
only a concept that has never been tested on a meaningful scale under
actual meat establishment conditions, and never proven to significantly
improve the microbial quality of the finished product. Although HACCP
has been tested in food processing establishments to the satisfaction
of scientists, food technologists, and industry management to produce
safe food, the Agency recognizes that the potential effectiveness of
HACCP in reducing pathogens within a regulatory framework is unknown at
the present time. FSIS conducted a pilot HACCP study in nine
establishments from 1991 to 1993. Findings regarding pathogen reduction
effectiveness were inconclusive. FSIS did not receive any data during
the comment period from establishments currently operating HACCP
systems. Rather than select an arbitrary effectiveness estimate, or use
the maximum potential 100 percent estimate from the preliminary
analysis, this RIA will present a range of effectiveness estimates and
show the minimum level necessary to generate net benefits.
6. Estimated Reduction in Cost of Foodborne Illness
Several comments focused on the issue that the relationship between
pathogen reductions at the manufacturing stage and foodborne illness
reductions is unknown. The comments recognize that the proposal did
acknowledge that little data exist on the relationship between pathogen
levels and incidence of illness. One comment pointed out that FSIS
recognized that the pathogen testing requirements that are part of the
proposal will help to elucidate the relationship between pathogen
contamination and foodborne disease. The commenter concluded that it
did not seem reasonable for the Agency to rely on an assumption, whose
very validity can only be tested by the implementation of the proposal
under examination, to justify the proposal.
[[Page 38968]]
Other commenters concluded that the Agency needed to develop better
data or complete a thorough risk assessment that would establish the
public health benefits of pathogen reduction before proceeding.
The comments asking for better data or requesting a thorough risk
assessment are not comments on the cost-benefits analysis. These
comments imply there is insufficient evidence to support new pathogen
reduction efforts. This issue is addressed in the preamble to the final
rule. The comments have made a policy judgment with which the
Department does not agree.
For the benefits analysis included with the proposed rule, FSIS
assumed that a reduction in pathogens will lead to a corresponding
proportional reduction in foodborne illness. The Department notes that
the IFSE study referred to favorably by many commenters used the same
method for estimating public health benefits as did FSIS, i.e., a
reduction in pathogens leads to a proportionate reduction in illness
and death. The Agency is aware that the proportionate reduction method
is an assumption that has not been tested or validated. However, the
Agency also recognizes that research methodology for relating pathogen
levels at establishments to incidence of illness is in its early
developmental stages. Risk models for foodborne pathogens are likely to
develop as the basis for regulatory decision-making in the future. The
Agency believes the implementation of mandatory HACCP will improve food
safety and protect public health while research in modeling risk
associated with foodborne pathogens continues.
The Agency has and continues to support any effort to improve the
quality of data and methodology available for risk assessment of
illness caused by foodborne biological agents. FSIS, FDA, CDC, and
local public health departments are collaborating with state health
departments and local investigators at five locations nationwide to
identify more accurately the incidence of foodborne illness, especially
illness caused by Salmonella and E. coli O157:H7.
G. Summary
The final rule addresses four pathogens that are estimated to cause
from $1.1 to $4.1 billion in annual illness and death costs
attributable to meat and poultry products. The rule addresses 90
percent of that cost of illness or from $0.99 to $3.69 billion
annually. FSIS recognizes that the actual effectiveness of the final
requirements in reducing pathogens is unknown, and presents a range of
benefits based on reducing varying percentages of the $0.99 to $3.69
billion in annual cost of foodborne illness addressed by this rule.
References
International Commission on Microbiological Specifications for
Foods (ICMSF). 1980. Microbial Ecology of Foods: Factors Affecting
Life and Death of Microorganisms. Volume I. Academic Press, New
York. Pp. 215-231.
Rolfe, R.D. 1991. Population dynamics of the intestinal tract.
In: Colonization Control of Human Bacterial Enteropathogens in
Poultry. Ed. L.C. Blankenshipp, J.S. Bailey, N.A. Cox, S.E. Craven,
R.J. Meinersmann, N.J. Stern. Academic Press, Inc., New York. Pp.
59-76.
Centers for Disease Control (CDC). 1988. Campylobacter isolates
in the United States, 1982-1986. In: CDC Surveillance Summaries.
June 1988. MMWR 1988; 37 (No. SS-2:1-13).
Blaser, M.J. & L.S. Newman. 1982. A review of human
salmonellosis: I. Infective dose. Reviews of Infectious Disease.
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Buchanan, R.L. & R.C. Whiting. 1996. Risk assessment and
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Council for Agricultural Science and Technology (CAST). 1994.
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Haas, C.N. 1983. Estimation of risk due to low doses of
microorganisms: A comparison of alternative methodologies. Am. J.
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National Research Council. 1983. Committee on Institutional
Means for Assessment of Risks to Public Health. Risk Assessment in
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Tappero, J.W. et al. 1995. Reduction in the Incidence of Human
Listeriosis in the United States; Effectiveness of Prevention
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Gellin, B., C.V. Broome, R. Weaver and A.W. Hightower.
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p. 155. Washington, DC: American Society for Microbiology, 1987.
V. Cost Analysis
A. Introduction
The final HACCP rule includes several regulatory components all
directed at improving process control in meat and poultry operations in
order to reduce the risk of foodborne illness associated with meat and
poultry products. The requirements of the final rule are organized
around the following three sections:
Requirements that all inspected establishments develop and
implement sanitation Standard Operating Procedures (SOP's) within 6
months.
Requirements that all inspected establishments develop and
implement HACCP programs within the 18 to 42 month time period
following publication. Scheduling will be based on establishment size.
Requirements that (1) all establishments slaughtering
cattle, swine, chickens, or turkeys, or producing a raw ground product
from beef, pork, chicken or turkey comply with new pathogen reduction
performance standards for Salmonella and (2) all establishments
slaughtering cattle, swine, chicken or turkeys implement microbial
testing programs using generic E. coli within 6 months. Compliance with
the pathogen reduction performance standards for Salmonella will be
required at the time the establishment is required to implement HACCP.
This cost analysis is presented in three sections. The first
section describes the methodology used in generating cost estimates.
The next section addresses the regulatory flexibility designed to
reduce the burden on small business. The last section presents the cost
estimates for each regulatory requirement. For each broad requirement,
the discussion of the cost estimates is organized using the following
five topics:
Summary of the requirements in the final rule identifying
any changes from the proposal.
Review of the cost estimates from the preliminary RIA.
Summary of the comments related to the preliminary cost
estimates.