[Federal Register Volume 62, Number 111 (Tuesday, June 10, 1997)]
[Notices]
[Pages 31553-31562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15115]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 96-008N]
HACCP-Based Meat and Poultry Inspection Concepts
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) must change how
resources are allocated in order to improve regulation of the meat and
poultry industries after implementation of the Pathogen Reduction;
Hazard Analysis and Critical Control Point (PR/HACCP)Systems final
rule. Every aspect of traditional FSIS methods of inspection for
slaughter and processing needs to be reconsidered. All methods are
subject to change as long as the Agency can fulfill its
responsibilities to ensure that the industries produce safe, wholesome,
unadulterated and properly labeled meat and poultry products. The
Agency is also considering adding methods to better ensure food safety
and other consumer protections in distribution channels.
FSIS is seeking comments on the development of new inspection
models for slaughter and processing in a HACCP environment. FSIS also
invites the public to participate in the development of new inspection
models and will hold a public meeting to facilitate that process.
DATES: The public meeting is scheduled for June 24, 1997, from 8 a.m.
to 5 p.m.
COMMENTS: Comments are welcome at any time. Please submit written
comments to Ms. Patricia Stolfa, Assistant Deputy Administrator, Office
of Policy, Program Development and Evaluation, Room 402 Cotton Annex,
300 12th Street SW, Washington, D.C. 20250-3700. Comments may also be
provided by facsimile (202-401-1760).
ADDRESSES: The public meeting will be held in Galleries 1, 2, and 3 of
the Arlington Hilton Hotel, 950 North Stafford Street, Arlington, VA
22203. The hotel has reserved a block of rooms until June 13 for
participants in the public meeting. Please contact the hotel at (800)
445-8667 and cite code USDAFSIS to make reservations.
FOR FURTHER INFORMATION CONTACT: To register for the public meeting,
contact Ms. Mary Gioglio at (202) 501-7244, (202) 501-7138, or FAX
(202) 501-7642. Persons wishing to speak at the public meeting are
requested to submit an advance written summary of their remarks. Please
submit written summaries pertaining to in-plant and/or in distribution
inspection concepts to Ms. Patricia Stolfa, Assistant Deputy
Administrator, Office of Policy, Program Development and Evaluation,
Room 402 Cotton Annex, 300 12th Street SW,Washington, D.C. 20250-3700.
Participants who require a sign language interpreter or other special
accommodations should contact Ms. Gioglio at the above telephone or FAX
numbers by June 10, 1997.
Background
This notice is organized into five sections. Section I
(Introduction) explains the current status of the FSIS regulatory
program and its food safety goals and strategy, and describes the
Agency's consumer protection activities included in its current
program. This section discusses the need for resource redeployment in
light of the Agency's overall modernization effort. Section II (Current
Inspection System) explains the current program and identifies
significant inconsistencies between HACCP and the current program. This
section also summarizes external support for inspection reform. Section
III (HACCP-based Inspection Development Project) explains the project,
describes inspection model development activities, announces a public
process to assist in the development of new inspection models, and
solicits volunteer establishments for participation in development
activities. Section IV (New Inspection Models) presents current agency
thinking on new in-plant and in-distribution models. Section V (Public
Meeting) proposes material questions the Agency will address through
the public process.
I. Introduction
Food Safety Goal
FSIS is committed to making fundamental improvements in the safety
of America's meat and poultry supply in order to reduce the incidence
of foodborne illness. In the preamble to the proposed rule ``Pathogen
Reduction; Hazard Analysis and Critical Control Points (PR/HACCP)
Systems'' (60 FR 6774; February 3, 1995), FSIS stated its
[[Page 31554]]
goal as follows: ``* * * 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.)
An essential first step in achieving that goal was accomplished
with promulgation of the PR/HACCP Systems final rule (61 FR 38806; July
25, 1996).
The PR/HACCP final rule mandates substantial change within every
inspected meat and poultry establishment. The new regulations: (1)
Require that each establishment develop, implement, and follow written
sanitation standard operating procedures (S-SOP's); (2) require regular
microbial testing by slaughter establishments to verify the adequacy of
their 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 risk-
based system of preventive controls known as HACCP to improve product
safety.
In mandating these reforms, FSIS recognized that in-plant
technological and procedural solutions could not address foodborne
illness hazards occurring in meat and poultry products outside official
establishments. These components of the goal could be achieved only
through a more comprehensive food safety strategy that would bring
about improvements in risk management at each step in the meat and
poultry production chain. Efforts must extend from just before
slaughter, through slaughter, processing, distribution, and retail sale
or food service, to consumers.
FSIS' Food Safety Strategy
The food safety strategy FSIS outlined in its PR/HACCP final rule
included five major elements:
(1) Provision for systematic prevention or reduction of biological,
chemical, and physical hazards through adoption by meat and poultry
establishments of science-based process control systems.
(2) Targeted efforts to control and reduce harmful bacteria on raw
meat and poultry products.
(3) Adoption of food safety performance standards that provide a
catalyst for innovation to improve food safety and a measure of
accountability for achieving acceptable food safety results.
(4) Removal of unnecessary regulatory obstacles to innovation.
(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.
The PR/HACCP final rule included regulatory provisions to implement
food safety strategy components (1) Hazard prevention through HACCP and
other production control systems, (2) reduction and control of
bacterial pathogens and (3) adoption of food safety performance
standards. Earlier, FSIS had published an Advance Notice of Proposed
Rulemaking (ANPR) (60 FR 67469 December 29, 1995) in pursuit of
strategy component (4), the elimination of unnecessary regulatory
obstacles to innovation. That notice announced a comprehensive review
of all FSIS regulations to determine which will still be needed when
the PR/HACCP final rule becomes effective and which ought to be
revised, streamlined or eliminated. That review is well underway and a
series of proposals will be published in the Federal Register to
consolidate and remove or modify existing requirements to make them
performance standards.
The PR/HACCP final rule did not address hazards arising at other
points in the farm to table continuum: for instance, during the
transportation, storage and retail, restaurant or food service sale of
meat and poultry products. Yet each stage of production presents
hazards of pathogen and other contamination and each provides
opportunities for preventing or mitigating these hazards. Those in
control of each segment of the farm to table continuum must accept
their share of the responsibility for identifying and preventing or
reducing food safety hazards that are under their operational control.
FSIS's food safety mandate requires that the Agency address
foodborne illness hazards within each segment of the food production
chain and that it implement and encourage prevention strategies that
improve the whole system. FSIS remains committed to a farm to table
food safety strategy based on these principles. Commenters on the PR/
HACCP proposed rule supported FSIS modernization of its regulatory
program to include all segments of the food production and
transportation industries.
The Agency also will be cooperating with animal producers,
academia, the Animal and Plant Health Inspection Service, the Food and
Drug Administration, the States, and other government agencies to
develop and foster voluntary food safety measures which can be taken on
the farm to decrease the public health hazards in animals presented for
slaughter.
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, FDA, and
the State and local agencies recognize that, if they are to reduce
foodborne illness to the maximum extent possible, they must coordinate
their food safety missions when addressing hazards that may arise in
distribution and at retail. FSIS has initiated a number of activities
which could form the basis for future regulatory activities at various
points on the continuum.
In 1995, FSIS, FDA, and the Department of Transportation contracted
with an expert group, the transportation Technical Analysis Group
(TAG), to identify the hazards associated with transportation of
perishable foods and to recommend reasonable controls that might be
employed by industry to ensure food safety. Using the HACCP system, the
TAG conducted a hazard analysis of the two major areas of concern in
the trucking transportation chain: the transport of live animals or
fresh materials, and the transport of processed or finished products
that are perishable. The TAG concluded that a program to ensure more
sanitary and temperature-controlled food transportation would benefit
both the industry and consumers.
In conjunction with FDA, FSIS issued a November 22, 1996, Advance
Notice Of Proposed Rulemaking (61 FR 59372) seeking comments and
information on various issues and alternatives for ensuring the safety
of potentially hazardous foods during transportation and storage. FSIS
and FDA also co-hosted a conference in November 1996, focusing on
transportation, storage and distribution of potentially hazardous
foods. The conferees discussed ideas related to in-distribution
regulatory activities to be considered by FSIS and FDA regarding meat,
poultry, eggs,
[[Page 31555]]
seafood, dairy, and other potentially hazardous food products. A
transcript of this conference is available from the FSIS hearing clerk.
Other Consumer Protection Activities
In addition to its food safety goal, FSIS also has other consumer
protection responsibilities under the laws it administers that are the
subject of many agency activities. These include ensuring that meat and
poultry products are truthfully labeled and not economically
adulterated with less valuable components such as water, and ensuring
that consumers are protected from unwholesome meat and poultry products
which, while not actually unsafe, might contain components which are
undesirable.
Regulatory Objectives
The FSIS regulatory program of the future will be designed first to
meet the Agency's food safety goal and strategy, along with our
consumer protection responsibilities. The Agency realizes it must have
the participation of all stakeholders to achieve our food safety goal
and other objectives. FSIS is therefore seeking public input on the
design and development of its HACCP-based program. FSIS believes that
there are at least three essential objectives that will form the basis
of this modern HACCP-based program.
First, FSIS must ensure that any new inspection models do
not diminish the current food safety and consumer protection
achievements that result from (1) carcass-by-carcass and bird-by-bird
slaughter inspection, and (2) Agency inspection oversight of production
control systems in further processing establishments.
The second objective is to effectively and efficiently
oversee, evaluate, and verify industry implementation of the PR/HACCP
final rule. HACCP, combined with other production control systems and
FSIS inspection oversight, are complementary and interrelated, but
independent activities that, taken together, enhance the safety of
foods for consumers and thereby earn their confidence. Maintenance of
such confidence shall be the critical test for any changes.
The third regulatory objective is to ensure that meat and
poultry products are handled and transported by allied industries under
conditions which maintain their safety and integrity. FSIS intends to
gather information about industry practices relative to handling,
transport, and storage of meat and poultry products to determine
whether businesses are effectively managing food safety risks and
ensuring that other consumer protections remain intact.
Need for Resource Redeployment
FSIS will be unable to meet its food safety goal and other
regulatory objectives unless it changes the way it deploys its
resources. Currently, inspectors are fully, and frequently more than
fully, occupied with carrying out the tasks of the present inspection
system. Those tasks require that about 45% of the entire inspector
field force be stationed at fixed positions along production lines in
slaughter establishments. Current slaughter inspection staffing is
directly related to industry production capacity. Higher production
capacity requires the Agency to staff more inspection positions.
Occasionally, staffing limitations negatively impact plant production
rates.
FSIS recognizes that the opportunities for inspector redeployment
are limited because current slaughter inspection regulations and
procedures are, by design, resource-intensive. Seventy-two percent
(72%) of the agency's in-plant inspection force is now assigned to
slaughter or combination slaughter and processing establishments that
make up only twenty-one (21%) of all establishments requiring federal
inspection. Current slaughter inspection procedures obligate sixty-two
percent (62%) of those in-plant slaughter inspectors (or 45% of the
entire inspection force) to carcass-by-carcass and bird-by-bird post-
mortem inspection.
FSIS believes it must explore alternatives to its current
inspection design and resource deployment models. Redeployed resources
would be allocated to new inplant functions associated with oversight,
evaluation, and verification of the PR/HACCP final rule implementation.
Other redeployed resources could be assigned to in-distribution
oversight.
II. The Current Inspection System
This section describes current inspection system practices,
especially within slaughter establishments, and illuminates several
crucial problems with the current system that present barriers to the
efficient and effective allocation of resources.
FSIS now carries out its meat and poultry food safety
responsibilities primarily through in-plant slaughter and processing
inspection programs. Under the current in-plant inspection system, FSIS
inspects carcasses and parts of all livestock and birds to detect
noncompliance with regulatory requirements, and requires correction of
each product, production, facility, equipment and sanitation defect
that occurs.
The current inspection system assumes that all livestock and birds
and their carcasses and parts are presented for inspection with the
intention of being prepared for use as human food. FSIS inspectors are
required to determine which are wholesome, not adulterated, and capable
of use as human food. FSIS inspectors decide whether to pass, condemn,
or allow salvage of carcasses or parts thereof. Under the current
system, FSIS uses inspectors at fixed stations on each slaughter line
to organoleptically identify disease lesions or defects in carcasses,
viscera and, in some species, heads.
Problems With Current Inspection
FSIS has identified several problems with the current approach. One
major problem is that as slaughter establishments have come to rely on
FSIS personnel to sort acceptable from unacceptable product, the
establishments have no mandate or incentive to remove carcasses and
parts prior to presentation for inspection. Thus, the proper roles of
industry and inspection personnel are obscured. FSIS' resources are
inappropriately and inefficiently used when FSIS slaughter inspectors
take on the industry's responsibility for finding defects, identifying
corrective actions, and solving production control problems.
A much more significant problem with the current inspection system
is that it does not permit FSIS to allocate resources according to
public health risk. For instance, the current line inspection system
required by regulation in meat and poultry slaughter establishments
focuses substantial FSIS inspection resources on areas that do not
present significant food safety risks. The carcass inspection
procedures carried out by FSIS inspectors today were designed many
years ago in response to a higher prevalence of disease in the animal
populations of that era. Over the years, significant advancements have
been made in the control or eradication of many animal diseases,
especially those that are transmissible to humans, such as tuberculosis
and brucellosis. Also, animal production practices have become more
efficient so that most livestock and poultry are slaughtered at a young
age, generally free of diseases more common in older animals.
Nonetheless, inspection methods have not changed.
Inspection methods have also not been modified sufficiently to
address
[[Page 31556]]
the microbial causes of foodborne illness. Current inspection methods
continue to rely on organoleptic identification of defects as
indicators of possible microbial risk. Measuring microbial hazards in
the design of HACCP plans through testing for actual microbial levels
and validation of control measures will occur during implementation of
the PR/HACCP final rule. Since new inspection models should reflect
this focus on pathogen reduction and microbial monitoring and
verification, the current reliance on organoleptic inspection should be
carefully reassessed.
The following data illustrate the results of current FSIS line
inspection. The overall level of carcass condemnation is low, 0.9
percent of young chickens, 0.1 percent of steers and heifers, and 0.3
percent of market hogs. Many carcass defects that result in
condemnation by FSIS slaughter inspectors today are aesthetic rather
than food safety related, such as pigmentary conditions and tumors.
Condemnation for food safety reasons is even lower, 0.4 percent of
young chickens, 0.08 percent of steers and heifers, and 0.23 percent of
market hogs. Inspection resources are now used to directly observe
1,000 young chickens to find four (4) that should be condemned for food
safety concerns. Similarly 10,000 steers and heifers are observed to
condemn eight (8) and 1,000 market hogs (barrows and gilts) are
observed to condemn two (2). Tables 1, 2 and 3 summarize carcass
condemnation data from fiscal year 1995. These data underscore the need
to reassess our current use of extensive inspection resources in this
area and to ask what staffing levels and patterns are appropriate for
the level of risk they address. FSIS believes that updating the
diseases and conditions subject to condemnation or restriction under
the PPIA and FMIA is long overdue and crucial to the development of new
inspection models. Certain diseases and conditions unrelated to food
safety, but currently addressed in the regulations, may be more
appropriately addressed by industry monitoring.
Table 1.--FY 1995 Condemnation Data for Young Chickens
----------------------------------------------------------------------------------------------------------------
Total slaughtered 7,512,916,376
-----------------------------------------------------------------------------------------------------------------
Number Percent
Condemnation condition Potential public health concern condemned condemned \1\
----------------------------------------------------------------------------------------------------------------
Septicemia/toxemia......................... Yes................................ 23,684,719 0.30
Synovitis.................................. No................................. 489,101 0.01
Contamination.............................. Yes................................ 6,190,429 0.08
Manufacturing defects...................... No................................. 20,984,146 0.28
Aesthetic defects.......................... No................................. 18,990,884 0.25
-------------------------------
Totals................................. ................................. 70,339,279 0.94
----------------------------------------------------------------------------------------------------------------
\1\ Percentages do not total 0.94 due to rounding.
The disease conditions with potential public health implications
are easily identified by visual assessment. Manufacturing defects
include such items as bruises, cadaver, over scalded, missing viscera,
and plant rejects. Aesthetic conditions with no known food safety
concern include leukosis, other tumors, and airsacculitis.
Table 2.--FY 1995 Condemnation Data for Steers and Heifers
----------------------------------------------------------------------------------------------------------------
Total slaughtered 28,807,882
-----------------------------------------------------------------------------------------------------------------
Number Percent
Condemnation condition Potential public health concern condemned condemned \1\
----------------------------------------------------------------------------------------------------------------
Septicemia/toxemia......................... Yes................................ 10,630 0.04
Inflammatory conditions.................... Yes................................ 8,270 0.03
Tuberculosis............................... Yes................................ 41 0.00
Ante-mortem conditions..................... Yes................................ 1,802 0.01
Parasitic/fungal........................... Yes................................ 2,678 0.01
Metabolic.................................. No................................. 2,081 0.01
Visually identifiable...................... No................................. 2,352 0.01
Tumors..................................... No................................. 671 0.00
-------------------------------
Totals..................................... .................................. 28,525 0.10
----------------------------------------------------------------------------------------------------------------
\1\ Percentages do not total 0.10 due to rounding.
Some condemnable conditions are identified ante-mortem by visual
assessment and animals with these conditions are not allowed to enter
the slaughter department, including animals arriving dead, those with
central nervous system disorders, moribund animals, those with tetanus,
and those with fever (pyrexia). Metabolic conditions include cachexia
and uremia and are identified by visual assessment. Other conditions
are identifiable post-mortem by visual assessment, including icterus,
eosinophilic myositis, tumors, and pigment conditions.
[[Page 31557]]
Table 3.--FY 1995 Condemnation Data for Barrows and Gilts
----------------------------------------------------------------------------------------------------------------
Total slaughtered 89,530,876
-----------------------------------------------------------------------------------------------------------------
Number Percent
Condemnation condition Potential public health concern condemned condemned \1\
----------------------------------------------------------------------------------------------------------------
Septicemia/toxemia......................... Yes................................ 36,641 0.04
Inflammatory conditions.................... Yes................................ 24,701 0.03
Tuberculosis............................... No................................. 1,262 0.00
Ante-mortem conditions..................... Yes................................ 137,998 0.15
Parasitic/fungal........................... Yes................................ 47 0.00
Metabolic.................................. No................................. 1,448 0.00
Visually identifiable...................... No................................. 14,717 0.02
Tumors..................................... No................................. 2,685 0.00
-------------------------------
Totals................................. .................................. 219,499 0.25
----------------------------------------------------------------------------------------------------------------
\1\ Percentages do not total 0.25 due to rounding.
The conditions with potential public health implications are easily
identified by visual assessment. Some condemnable conditions are
identified on livestock and birds ante-mortem by visual assessment and
not allowed to enter the slaughter department, including animals
arriving dead (accounts for over one-half of all condemnations), those
with central nervous system disorders, moribund animals, those with
tetanus, and those with fever (pyrexia). Metabolic conditions include
cachexia and uremia and are identified by visual assessment. Other
conditions are identifiable at post-mortem by visual assessment,
including icterus, eosinophilic myositis, tumors, and pigment
conditions.
Despite the fact that many condemnations are unrelated to public
health risks, today FSIS still fully staffs every meat and poultry
establishment slaughter line inspection station. Assigning top priority
to slaughter line inspection activities to detect quality as well as
defects of public health concern directly affects the Agency's ability
to staff other critical food safety inspection activities and may not
be the best use of inspection resources. For example, FSIS inspectors
in slaughter establishments are assigned the task of verifying
establishment production control systems for sanitary dressing of
slaughtered animals and operational sanitation of equipment and
facilities. If, however, slaughter line inspection positions become
vacant, inspectors are removed from these important verification duties
to fill the line positions. This means that important production
control systems, which prevent or eliminate hazards such as bacterial
pathogens, are only monitored by plant employees with little FSIS
inspection verification.
The current inspection system can also raise barriers to
establishment innovation through new technology and improved production
procedures. Establishments should have the flexibility to implement the
PR/HACCP final rule and to make decisions about how they may best
control food safety hazards and meet performance standards.
Establishments should have the latitude to develop new production
control methods to detect food safety and non-food safety related
defects in carcasses and parts. Current slaughter inspection methods,
particularly fixed inspector stations on establishment slaughter lines,
limits industry innovation.
External Support for Inspection Reform
Recent outbreaks of foodborne illness have focused attention on the
need for improving the current system. Studies conducted over the past
decade by the National Academy of Sciences (NAS), the General
Accounting Office, and by FSIS have established the need for
fundamental change in the meat and poultry inspection program. Two
elements have been commonly expressed: FSIS should revise and reform
inspection to (1) Improve food safety through a reduction in foodborne
illness caused by pathogenic bacteria on meat and poultry products and
(2) make better use of its resources. Bacteria, including Salmonella,
E. Coli 0157:H7, Campylobacter and Listeria Monocytogenes, are
significant food safety hazards associated with meat and poultry
products. The contamination of meat and/or poultry with these bacteria
is estimated to result annually in as many as 4,000 deaths and
5,000,000 illnesses.
The theme of NAS's recommendations is that FSIS should reduce its
reliance on organoleptic inspection and shift to prevention-oriented
inspection systems based on risk assessment. The 1985 NAS report, Meat
and Poultry Inspection: The Scientific Basis of the Nation's Program,
recommended that FSIS focus on pathogenic organisms and require that
all official establishments operate under a HACCP system for control of
pathogens and other safety hazards. This report strongly encouraged
``FSIS 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.''
Two later NAS studies reinforced this recommendation. The 1987 NAS
report Poultry Inspection: The Basis for a Risk Assessment Approach
concluded ``that the present system of inspection does very little to
protect the public against microbial hazards in young chickens.'' The
report continued to say that ``[Agency] resources are not always
allocated to the right points and the resources that are properly
directed are not achieving measurable results. Major changes are
required in the poultry inspection system if public health is to be
protected and if the investment of resources is to have maximum
effect.'' It recommended that FSIS adopt an inspection strategy ``that
is more likely to have a substantial impact on human diseases.'' The
1990 NAS report Cattle Inspection: Committee on Evaluation of USDA
Streamlined Inspection System for Cattle (SIS-C) added that although
``traditional meat inspection, relying on organoleptic examinations,
can ensure satisfactory meat product quality, it is not fully effective
in protecting the public against foodborne health hazards not
detectable with these techniques. The future will require new ways of
preventing public exposure to contaminants, scientifically valid and
believable methods of evaluating inspection technology, and
implementation of appropriate portions of HACCP programs.''
[[Page 31558]]
The General Accounting Office (GAO) has advocated similar
improvements for meat and poultry inspection in its reports. (Food
Safety: A Unified, Risk-Based Food Safety System Needed (1994); Meat
Safety: Inspection System's Ability to Detect Harmful Bacteria Remains
Limited (1994); Food Safety: Building a Scientific, Risk-Based Meat and
Poultry Inspection System (1993); Food Safety and Quality--Uniform,
Risk-Based Inspection System Needed to Ensure Safe Food Supply (1992).)
The GAO has endorsed HACCP as a scientific, risk-based system that
would permit redeployment of FSIS resources in a manner that will
better protect the public from foodborne illness. The 1994 GAO report,
Meat Safety: Inspection System's Ability to Detect Harmful Bacteria
Remains Limited, stated the resource problem clearly. ``Labor-intensive
inspection procedures and inflexible inspection frequencies drain
resources that could be put to better use in a risk-based system. To
better protect the public from foodborne illnesses, FSIS must move to a
modern, scientific, risk-based inspection system. Such a system would
allow FSIS to target its resources toward the higher-risk meat and
poultry products by increasing inspection of such products.''
Another proponent of inspection reform has been the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF),
which prepared reports on the development and implementation of HACCP.
NACMCF supported the use of risk analysis for allocation of resources
to control food safety.
III. HACCP-Based Inspection Development Project
With this notice, FSIS is initiating the process of dialogue with
all interested parties to advance the design and development of new
inspection models to be tested in a series of trials in volunteer meat
and poultry slaughter establishments and in distribution channels. This
project is intended to produce a fully integrated system of regulatory
oversight and controls that will permit FSIS to deploy inspection
resources more effectively in-plant and between in-plant and in-
distribution sites in accord with food safety and other consumer
protection requirements.
Objectives for New Inspection Models
The development of new in-plant and in-distribution inspection
models will occur in three phases.
Phase I. Initiation: Conduct public meeting to explain the need for
new inspection models and to commence a public dialogue on the
available options for their design, complete preliminary designs, and
prepare for development activities.
Phase II. Development: Conduct development activities in commercial
establishments and at in-distribution points to refine the models,
gather data, generate implementation strategies.
Phase III. Completion: Write the final report, publish results for
comment, and initiate rulemaking, as appropriate, to change existing
inspection procedures.
During each phase, the in-plant and in-distribution inspection
methods will be developed separately. The purpose of a two-track
development is to test and refine the new inspection concepts in both
commercially operating meat and poultry establishments and with in-
distribution activities at several geographic sites. Throughout the
development phase, FSIS will be prepared to revise or suspend current
inspection procedures provided that appropriate oversight controls are
maintained in volunteer establishments.
This notice announces the first step in Phase I, a public meeting
to present the need for new inspection concepts and to commence a
public dialogue on these concepts. At this meeting, FSIS will describe
its current thinking, seek information from all stakeholders, and use
that input to complete preliminary designs for new in-plant and in-
distribution inspection models suitable for testing and development.
FSIS needs the broadest possible public participation in the
development of these models.
FSIS will prepare a transcript of the public meeting. The
transcript and copies of any papers presented at the meeting will be
available in the FSIS Docket Clerk's Office, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250-3700.
Development Phase
FSIS development activities for new in-plant inspection systems
will critically examine how well each design meets the Agency's
regulatory objectives. In-plant tests will be conducted in
establishments that predominantly slaughter young chickens, market hogs
and steers/heifers. Volunteer establishments will be sought for each
class. Young chickens, market hogs and steers/heifers were selected for
these development activities because they tend to be healthy and
uniform; they also represent over ninety percent (90%) of meat and
poultry slaughtered in the United States.
Slaughter and combination slaughter and processing plants
participating as volunteers will be required to have HACCP and other
production controls in place to ensure that all consumer protection
goals of the program are being met. Participating establishments must
also have successful S-SOP's and a working generic E. coli testing
program.
FSIS solicits establishments to volunteer for participation in the
in-plant development phase. Establishments requesting to participate
should request to do so in writing to FSIS at the address provided in
the ADDRESSES portion of this notice. Written applications for
participation in the development activities should provide a
description of establishment operations that includes predominant
species slaughtered, number and type of slaughter lines, and a
certification that all applicable elements of the PR/HACCP final rule
have been or will be fully implemented. FSIS will conduct an on-site
visit to verify eligibility for participation in the development
activities.
FSIS intends to assign inspection work more broadly during the in-
plant development activities to explore new methods for performing
regulatory work. For instance, if volunteer establishments conduct both
slaughter and processing operations, inspectors might be assigned to
perform work that cuts across traditional job lines. Within the
slaughter operation, inspectors could provide oversight, evaluation,
and verification of carcass-by-carcass and bird-by-bird industry
determination of acceptable and unacceptable product. Inspectors would
have access to perform hands-on inspection of carcasses or birds. They
would perform additional tasks in slaughter and processing for
assurance that products bearing the official inspection mark are not
adulterated or misbranded, including verification of HACCP or S-SOP's.
Such changes would provide FSIS with considerable data with which to
evaluate the effectiveness of its inspection resources.
Staffing requirements for new in-plant inspection models could also
vary depending on factors such as species of animal, the
establishment's production system, and slaughter line configurations.
Nontraditional staffing criteria are under development. In-plant
slaughter inspection could (1) be staffed with available inspectors,
(2) provide for rotation of inspection personnel between slaughter and
processing duties, (3) provide continuous oversight of establishment
production systems, (4) include scheduling of slaughter inspection
tasks, and (5) provide unscheduled time for all inspection
[[Page 31559]]
personnel to conduct additional inspection activities in the
establishment.
In view of the mix of skills to be found among slaughter inspection
personnel, all slaughter inspectors currently assigned to the volunteer
establishments will be trained for the project to perform (1) carcass-
by-carcass and bird-by-bird slaughter inspection oversight, (2)
verification of HACCP and related production control systems, (3)
verification of establishment S-SOP's and (4) sampling.
The in-distribution development activities will be conducted on a
separate track. In-distribution concepts will be studied in geographic
areas selected to provide a variety of population densities and
differing logistical challenges for scheduling work. In addition, two
staffing options will be discussed at the public meeting: (1)
Inspectors assigned only to in-distribution activities, and (2)
inspectors who divide their time between in-plant and in-distribution
work. Both options will be considered for application in rural as well
as urban areas.
The in-distribution development activities will be staffed by
experienced in-plant inspectors with prior training in processing
inspection and supplementary training for the new work. This work will
include in-plant tasks that have been identified to be supplemented or
replaced by in-distribution oversight and tasks to determine the
feasibility, efficiency, and effectiveness of performing food safety
and other consumer protection tasks in distribution.
Completion
Upon completion of the development activities, FSIS will prepare a
project report presenting a thorough evaluation of the in-plant and in-
distribution inspection models tested. The Agency will decide at this
point whether further testing of the models should be conducted or
whether to initiate rulemaking to adopt and implement the new models
nationally.
IV. New Inspection Models
The following criteria will be used to design and evaluate new in-
plant and in-distribution models accepted for testing. The models
should:
1. Emphasize industry responsibility for food safety and other
consumer protection activities and government responsibility to verify
that these objectives are met.
2. Include inspection procedures that detach inspectors from
establishment production functions and from sanitation management.
3. Prioritize in-plant work to meet current inspection system
objectives and verify that HACCP and other control systems and
sanitation procedures are effective; provide appropriate priority to
other consumer protection issues such as misbranding or economic
adulteration.
4. Result from an assessment of all in-plant regulatory work to
determine whether some tasks can be performed effectively and
efficiently in-distribution and, where more appropriate, supplement
some in-plant regulatory work with in-distribution oversight.
5. Identify and prioritize new in-distribution regulatory work,
including oversight of how industry manages health and safety hazards
that occur after meat and poultry products leave a USDA-inspected
establishment and verification that products in-distribution are not
misbranded or economically adulterated.
FSIS will develop new in-plant inspection models for slaughter
establishments and combination slaughter and processing establishments
to help the Agency properly allocate resources between oversight,
evaluation and verification of PR/HACCP final rule implementation and
activities to accomplish other consumer protection objectives. The new
in-plant inspection models must also help the agency in properly
allocating resources between in-plant and in-distribution work
environments.
In-plant Inspection Models
A variation of the current inspection system has been identified as
a model to be considered and discussed at the public meeting announced
by this notice.
Under this in-plant model, the establishment would initiate HACCP
and related control systems to distinguish acceptable from unacceptable
carcasses and parts using current regulatory requirements for
antemortem and postmortem disposition of carcasses and parts.
This model would provide establishments maximum flexibility to
design and exercise more effective and more efficient production
control systems. FSIS inspectors would have complete access to all
carcasses and birds on each slaughter line to directly observe
establishment production systems and verify process controls to ensure
that products are not adulterated or misbranded. Consequently,
establishment product flow plans crafted for compliance with the PR/
HACCP final rule for other production control purposes would not
include fixed FSIS inspection stations.
FSIS intends to judge products for safety and wholesomeness based
upon the entire operation under which they are produced. FSIS
inspectors could provide continuous regulatory oversight of the entire
production operation to include each on-line processing step and all
aspects of the establishment that contribute to product safety and
wholesomeness.
FSIS envisions this inspection model as having three main
components that collectively would ensure equivalent performance to
that level of food safety and other consumer protections provided by
the current regulatory system. Slaughter performance standards that
define an acceptable carcass or part are the basis for the first
inspection component. FSIS would establish performance standards to
replace command and control regulations. Industry systems to meet the
performance standards would satisfy the first component.
The second component is direct verification by FSIS inspectors of
the establishment program. This would be accomplished by FSIS
inspectors who would provide carcass-by-carcass and bird-by-bird
inspection oversight at the slaughter line and by periodic checks to
verify the condition of carcasses and parts the establishment has found
to be acceptable.
The third component is verification of the overall establishment
program for producing acceptable product including verification of
HACCP, other production control systems, and S-SOP's.
This preliminary in-plant inspection model envisioned by FSIS would
require fewer inspectors assigned to slaughter plants, making
inspectors currently assigned to slaughter line positions available for
redeployment. This is consistent with HACCP principles and would reduce
or eliminate distinctions between slaughter and processing inspection
by allowing inspectors to rotate from post-mortem oversight positions
to work such as HACCP verification, finished product standards testing,
Performance Based Inspection System (PBIS) task performance, S-SOP
verification and microbial sampling.
FSIS Verification Activities
Under the new in-plant inspection model, FSIS would not prescribe
how industry must accomplish production control. Establishments would
instead be provided the flexibility, within performance and regulatory
standards set by FSIS, to design specific processes that address
hazards and defects unique
[[Page 31560]]
to their operations. FSIS would ensure that establishment HACCP and
other control system plans for achieving regulatory standards are
adequate and operating properly. Following is an illustration of steps
FSIS inspectors would take to oversee, evaluate, and verify
establishment production control systems.
Observe the production control systems; verify that
process control procedures are being followed by the establishment.
Observe carcasses, parts, or viscera rejected by the
establishment; provide information to the off-line inspector and
veterinarian as to which diseases or conditions are prevalent.
Observe carcasses, parts or viscera accepted by the
establishment; verify removal of obvious condemnable conditions.
Sample carcasses, heads or viscera accepted by the
establishment; select and examine a specific number of carcasses, heads
or viscera to verify the effectiveness of the establishment's system
for ensuring accepted product is wholesome and otherwise eligible for
the mark of inspection.
Review records to determine whether the establishment is
following its production control plans.
Observe product (carcasses, heads, and viscera) to
determine which conditions are present.
Coordinate with establishment manager, who provides
oversight of production control systems, to ensure that performance
standards are being applied correctly.
Conduct product standards testing (e.g., Finished Product
Standards, Acceptable Quality Level) to determine the effectiveness of
establishment production control systems for quality or wholesomeness
defects.
FSIS also will conduct verification checks of establishment
activities other than production control systems. For instance, FSIS
inspectors will:
Perform tasks related to the Performance-Based Inspection
System, including those historically performed after slaughter during
processing.
Conduct HACCP record reviews to verify that the
establishment is monitoring critical control points in accordance with
their HACCP plan.
Verify establishment disposition of rejected product.
Conduct operational verification activities, such as
assessing the establishment's execution of its HACCP plan.
Take samples of product for microbiological, chemical and
physical analysis to verify establishment compliance with its HACCP
plan.
Verify that the establishment is following its sanitation
SOP.
The FSIS Veterinary Medical Officer (VMO) will work closely with
inspectors to provide continuous oversight and thorough documentation
of establishment production control systems. VMO expertise and
responsibilities would include the following:
Serve as the Inspector-in-Charge; supervise food
inspectors.
Evaluate the health of incoming animals through ante-
mortem activities.
Perform ante-mortem inspection of suspect animals.
Verify establishment production control systems to ensure
proper application of disposition standards by inspectors and
establishment personnel.
Verify microbial sampling and testing of product.
Take microbial and histopathological samples of condemned
carcasses to profile etiologies.
Participate in the evaluation of testing or implementation
of new technologies initiated by establishments for identifying
condemnable carcasses.
Serve as liaison with establishment management, industry
technical experts and with local or State public health officials.
In-Distribution Concept
A new in-distribution inspection concept should provide for
verifying industry management of food safety risks that arise after
inspection. Resource allocation issues require an integrated approach
for both food safety and other consumer protection initiatives. Thus,
the in-distribution model may also supplement in-plant oversight of
product labeling, economic adulteration and wholesomeness requirements.
Although FSIS will develop and field-test new concepts for slaughter
and in-distribution separately, FSIS envisions one fully integrated
program that would permit movement of personnel and tasks between the
two activities.
At present, FSIS has no comprehensive rules governing the in-
distribution handling of meat and poultry products. The Agency now
exercises its jurisdiction over product outside inspected
establishments to a limited degree. For example, FSIS has promulgated
safe handling labels for raw meat and poultry products (9 CFR 317.2 (l)
and (m), and 381.125(b)); in many instances those labels are applied at
retail locations. FSIS also verifies and enforces compliance with
requirements concerning transportation to and among inspected
establishments and allied industries, such as renderers and pet food
establishments, conducts scheduled and unscheduled reviews of
warehouses and other in-distribution locations, verifies the recall of
product from in-distribution channels, performs scheduled and
unscheduled product sampling, and investigates complaints from
consumers and others about alleged adulterated or misbranded products.
This approach has been both proactive and reactive. FSIS has not
focused systematically on in-distribution conditions and practices that
contribute to the growth of microbes. FSIS uses resources to detect
problems, educate industry, correct violations, and make appropriate
dispositions on millions of pounds of product. However, the statutes
provide USDA authority to oversee meat and poultry products after they
leave inspected establishments. The statutes provide that one may not
``sell, transport, offer for sale or transportation, or receive for
transportation'' any meat or poultry product that is capable of use as
human food and is ``adulterated or misbranded at the time of such sale,
transportation, offer for sale or transportation, or receipt for
transportation * * *'' (21 U.S.C. 610 and 458(a)(2)). The statutes also
prohibit any action ``intended to cause or [that] has the effect of
causing such articles to be adulterated or misbranded.'' (21 U.S.C.
610(d) and 458(a)(3)).
This authority would encompass the establishment of safety
standards for meat and poultry products from the time they leave an
inspected establishment to final sale or service to consumers. As a
first step, FSIS has yet to determine whether performance standards and
Good Manufacturing Practices could and whether they can be established
for meat and poultry products to prevent growth of harmful bacteria and
introduction of other potential hazards during transportation.
FSIS is considering work accomplished by the transportation TAG, to
identify primary hazards associated with transportation of perishable
foods and controls that might be employed by industry to ensure food
safety. The TAG noted ``that time, temperature, and sanitation are the
three key elements of any control plan'' affecting the transportation
sector. The TAG also concluded that sanitary conditions and practices,
maintenance of product temperature in transit, time in transit, and
practices to reduce opportunities for cross contamination all represent
control points for which the development of regulatory standards, good
manufacturing
[[Page 31561]]
practices, and suitable verification controls are possible.
During in-distribution inspection concept development, FSIS will
gather data to describe impacts on pathogen levels attributable to
present allied industry practices. Data collection sources will include
allied industry members who volunteer to describe quality or safety
problems they experience with meat and poultry received from their
suppliers. These data will suggest points of concern within the
distribution chain that FSIS may need to address in its inspection
planning.
Another data collection effort could be to identify a microbial
baseline for certain products or product lots as they leave inspected
establishments and track them through the distribution chain to detect
and record changes caused by allied industry handling practices. The
nationwide status of the food safety and other consumer protection
aspects of meat and poultry products could be evaluated and profiles
developed. Evaluation of changes in profiles over time would measure
the effectiveness of in-distribution efforts to maintain food safety
and product integrity. Status reports on meat and poultry products
might be correlated with sentinel site surveillance data for foodborne
disease to track the public health impact of farm to table food safety
initiatives.
While time, temperature, and sanitation play a key role in
controlling hazards to perishable foods in transportation, they are not
the only factors that could be verified in the distribution chain. FSIS
will also determine whether some adulteration and misbranding
inspections presently conducted in-plant can be supplemented or perhaps
performed entirely in-distribution. Many meat and poultry products are
prepared by regulated establishments in consumer-ready packages.
Samples could be collected in the marketplace rather than in
establishments and subsequently analyzed in a laboratory for product
formulation, proper labeling, and compliance with microbial and residue
standards. For example, samples could be taken in-distribution to
profile water added hams to determine adherence to accurate labeling
and restricted ingredients requirements. Similarly, products produced
in bulk packages might also be sampled at points in-distribution beyond
where it was initially processed.
In-Distribution Alternatives
Transportation and storage are vital links in the farm to table
continuum. The Agency has been developing in-distribution concepts and
identified both available information and information gaps. Allied
industries responsible for transportation and storage of meat and
poultry have addressed product integrity issues for sometime. For
example, cold storage facilities, warehouses, depots, and similar kinds
of businesses have temperature and product handling controls that they
use to ensure the safe storage of foods. Such standards may have broad
applicability to in-distribution activities. The details about these
activities, however, are not adequately known to FSIS.
FSIS identified several alternatives to ensure safe transportation
and storage of food in its ANPR of November 22, 1996: Transportation
and Storage Requirements for Potentially Hazardous Foods (61 FR 59372).
These alternatives include specific requirements, such as temperature
standards, performance standards, record keeping to ensure that food
safety controls are maintained, mandatory HACCP-type systems, voluntary
guidelines, and combined approaches. These alternatives are summarized
below.
1. Temperature Requirements
One approach is the promulgation of a performance standard that
would require that potentially hazardous foods be cooled to and
maintained at or below a specific temperature during transportation and
storage from the food processing plant to the retail outlet,
restaurant, or other establishment serving the consumer. If this
approach is adopted, all potentially hazardous foods being transported
to retail or food service establishments would have to be maintained at
or below such a maximum temperature.
2. Shipper Recordkeeping
Another alternative could be recordkeeping requirements with
respect to the conditions under which foods that pose a risk as
vehicles for foodborne disease are transported interstate. The Agency
may consider requiring carriers of potentially hazardous foods that are
shipped in bulk (foods which directly contact a food conveyance) to
provide food shippers with records that identify the last three cargoes
for any conveyance being offered to the food shipper for use in
transporting the food and that disclose the data of the most recent
cleaning of the conveyance.
3. Mandatory HACCP-Type Systems
Another approach would be to require that a HACCP system be
established specifically with respect to the transportation and storage
of potentially hazardous foods to prevent the contamination of these
foods. Such requirements could be modeled on the regulations recently
adopted by FSIS that apply to establishments processing meat and
poultry.
Such HACCP-type systems could be relatively simple. Essentially,
they would likely require that potentially hazardous foods be
maintained at a particular refrigeration temperature or frozen
temperature, and that the temperature be recorded using a recording
thermometer. The use of a temperature standard would allow processors
to determine the acceptability of a food transport vehicle for the
transport of certain bulk foods, i.e., those that pose a risk of
foodborne disease, based on cargo records.
4. Voluntary Guidelines
Another approach under consideration is to make more use of
voluntary guidelines. Some government agencies, industry groups, and
other organizations have published guidelines or recommended practices
that address the transportation and storage of potentially hazardous
foods, whether fresh or frozen. Such guidelines, several of which are
discussed in the ANPR of November 22, 1996 (61 FR 59372), could serve
as the basis for developing joint government-industry guidelines for
food transportation and storage.
V. Public Meeting
Public participation in the development and implementation of the
new inspection models discussed in this notice is essential. In
addition to commentary on FSIS resource redeployment, specific
inspection models, and in-distribution inspection activities, the
Agency believes that comments addressing the following questions will
facilitate the public process.
What are the priority food safety objectives that must be
accomplished by FSIS' meat and poultry inspection system?
What other significant consumer protections should the
meat and poultry regulatory system provide?
How should the agency prioritize food safety and other
consumer protection objectives?
How much emphasis should FSIS place on detection of
aesthetic defects that are not related to food safety?
A major objective of the S-SOP requirement in the PR/HACCP
regulation was to make establishments more accountable for performing
all necessary sanitation functions before
[[Page 31562]]
and during operations. What other establishment operations might
benefit from similar regulatory approaches?
Is it necessary or desirable to employ the same inspection
methodology in all similar establishments?
What roles should Federal, State, and local governments
play in verifying the safe transportation and storage of potentially
hazardous foods?
How we can best coordinate with State and local
authorities to minimize restaurant and institutional outbreaks linked
to meat and poultry products?
How can FSIS verify allied industry management of food
safety risks as meat and poultry products move from the establishment
to consumers?
What systems do establishments have in place for ensuring
in-distribution protection of meat and poultry products? How does
industry measure the performance of these systems?
What in-plant inspection objectives can be supplemented or
replaced with in-distribution inspection models?
What additional suggestions are there for data collection
efforts to be carried out in distribution channels?
Are the in-distribution alternatives identified in the
ANPR of November 22, 1996 (61 FR 59372), useful? In what ways?
Done at Washington, DC on: June 4, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-15115 Filed 6-5-97; 3:26 pm]
BILLING CODE 3410-DM-P
