[Federal Register Volume 60, Number 169 (Thursday, August 31, 1995)]
[Proposed Rules]
[Pages 45380-45381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21671]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 60, No. 169 / Thursday, August 31, 1995 /
Proposed Rules
[[Page 45380]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 308, 310, 318, 320, 325, 326, 327, and 381
[Docket No. 95-039N]
Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems--Issue-Focused Public Meetings on the Proposed
Regulation
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Meeting notice; closing of comment period.
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SUMMARY: The U.S. Department of Agriculture is holding a series of
issue-focused public meetings on FSIS' proposed rule, ``Pathogen
Reduction, Hazard Analysis and Critical Control Point (HACCP)
Systems.'' The purpose of the meetings is to provide an opportunity for
interested persons to directly discuss the key concerns that were
raised during the comment period on the proposed rule, as well as the
Agency's thinking about options under consideration in response to
those concerns.
DATES: The issue-focused meetings will be held September 13-15 and
September 27-29, 1995, from 9:00 a.m. to 5:30 p.m.
The comment period for the proposed rule, ``Pathogen Reduction;
Hazard Analysis and Critical Control Point (HACCP) Systems'' (60 FR
6674, February 3, 1995), which reopened August 11, 1995 (60 FR 41029,
August 11, 1995), will close on October 30, 1995.
ADDRESSES: The meetings will be held at the U.S. Department of
Agriculture, Back of the South Building Cafeteria (between the 2nd and
3rd wings), 14th Street and Independence Avenue, SW, in Washington, DC.
FOR FURTHER INFORMATION CONTACT: Mr. Charles Danner, Director, Planning
Office, Policy Evaluation and Planning Staff, FSIS, USDA, Room 6904,
Franklin Court, Washington, DC 20250, (202) 501-7138. Anyone wishing to
attend should contact Ms Lisa Parks at (202) 501-7138. Anyone wishing
to obtain copies of the brief issue papers on agenda topics should
contact Mr. Andrew Moss at (202) 690-3774. Anyone requiring a sign
language interpreter or other special accommodations should make this
known to Ms. Parks. The proceedings will be transcribed, and the
transcripts will be made a part of the rulemaking record.
SUPPLEMENTARY INFORMATION: On August 23, 1995, USDA held a public
scoping session to discuss the agenda and format for the series of
issue-focused public meetings being held September 13-15 and 27-29,
1995, on the proposed rule, ``Pathogen Reduction; Hazard Analysis and
Critical Control Point (HACCP) Systems.'' Based on the discussion that
took place at the scoping session, the following format will be
observed for the issue-focused meetings:
Format
The issue-focused public meetings will be held on
September 13, 14, 15 and 27, 28, and 29 in the South Building of the
U.S. Department of Agriculture, Washington, DC.
The meetings are open to all interested parties. No
concurrent sessions will be held.
The meetings will be transcribed and made part of the
rulemaking record. It is, therefore, unnecessary for oral comments to
be duplicatively submitted in written form.
Interested parties may also provide written comments on
issues addressed in the meetings until October 30, 1995.
Each meeting will focus on the specific set of issues
provided in the agenda, below.
Interested parties with common concerns and positions on a
particular issue are encouraged to designate a representative to speak
for them on that issue.
Appropriate FSIS staff will attend and participate in the
meetings.
The moderator of the issue-focused public meetings will be
Thomas J. Billy, Associate Administrator, USDA Food Safety and
Inspection Service. The role of the moderator will be to foster
substantive and focused discussion and dialogue among attendees on
agenda items. The moderator will encourage an open and balanced
exchange of views while ensuring that discussions stay generally within
announced time frames, remain on the designated subject, and avoid
repetitious statements previously provided.
Based on meeting discussions, the moderator will determine
what additional issues will be included on the September 29 agenda.
Brief issue papers on agenda topics will be provided. See
Information Contact above.
Several issues raised in the scoping session, which did
not fall within the HACCP rulemaking, will be included for discussion
at the Secretary's Food Safety Forum in October.
Based on the discussion that took place at the scoping session, the
following agenda has been adopted:
Agenda
September 13, 1995
Overview of HACCP Proposal
A. Near-Term Measures
Role and rationale for sanitation standard operating
procedures (SOPs), antimicrobial treatments, carcass cooling
requirements for red meat as a transition to HACCP
B. HACCP Program
A tool for process control by industry
A regulatory tool for FSIS and States
The role of performance standards
Application to different segments of industry
--slaughter
--processing, including canned, frozen, and specialty foods
--small plants
Relationship to farm-to-table food safety strategy
C. Merging HACCP and Current System
Refocus of inspection tasks
Shift from command-and-control to performance standards
D. Timing
Agency implementation
Industry adoption of HACCP
[[Page 45381]]
FSIS Oversight of HACCP
A. Changing the Relationship Between FSIS and Inspected Plants
B. FSIS Inspection Under HACCP
Focus on industry's process control system and other
systems such as standard operating procedures (SOP's) for sanitation
Focus on government safety standards
C. Ensuring Compliance With HACCP Requirements
FSIS and plant accountability
Enforcement
Appeal process
Public access to HACCP records
Whistleblower protection for FSIS and plant employees
Changing Role of Inspectors Under HACCP
Focus on industry process control and other systems
Changing inspection tasks related to product and
production to focus on safety
Inspection outside plants
Training of inspectors for new roles
September 14
Regulatory Shift to Performance Standards--``Layering''
A. Eliminating Unnecessary and Redundant Regulations and Prior Approval
Requirements to Increase Industry's Ability to Innovate to Improve Food
Safety
B. Specific Changes Needed for Bringing FSIS Requirements Into Harmony
With HACCP
C. FSIS Role in Facilitating Development of HACCP Plans
Model plans
Guidance
Pilot demonstrations in small plants
September 15
Performance Standards and Microbial Testing
A. Establishing Performance Standards
Scientific and policy basis for establishing targets
Whether Salmonella is the appropriate organism for some or
all species
Whether other pathogens would be preferable for some or
all species
Utility of targets for E. coli or other non-pathogenic
indicator organisms as a means of controlling and reducing pathogenic
microorganisms
Advantages and disadvantages of targets based on the
incidence of detectable contamination (as proposed by FSIS) vs. targets
based on the number of organisms present
Need for pathogen reduction targets for raw ground
products in general, and in plants that both slaughter animals and
produce ground product
B. Measuring Achievement
Purpose of testing (verifying process control adequate to
achieve target consistently over time vs. enforcement of lot release
criterion)
Frequency of testing
Who should test (the plant, FSIS, third-party
laboratories, or a combination of the three); who should pay
Laboratory accreditation
September 27
Carcass Cooling Standards for Red Meat and Poultry
A. Feasibility of Proposal
B. Alternatives, Including Performance Standards
Antimicrobial Treatments in Slaughter Plants
A. Should Antimicrobial Treatments be Mandated
B. Alternatives
C. FSIS Role in Specifying Efficacy Standards
D. FSIS Role in Approving Substances/Processes
E. International Considerations
Sanitation Standard Operating Procedures (SOP's)
A. How SOP's Relate to HACCP
B. Alternatives
C. Need for FSIS Sanitation Guidelines
D. Clarification of Acceptable Format, Records
E. Implications of SOPs for FSIS Inspectors in Daily Commencement of
Plant Operations
F. Enforcement
September 28
Specific Economic and Product Considerations
A. General Economic Impact
B. Minimizing Economic Impact Without Compromising Food Safety Goals
C. Taking Account of Impacts on Small Business
Definition of small business
Options to minimize impact and assist small business
Implementation schedule
D. Taking Account of Impacts on Religious and Ethnic Slaughter and
Processing Practices
September 29
Remaining Issues and Review
A. International Considerations
Export issues
Import issues
B. Incentive-Based Alternatives, Such as Marketing Claims on Labels
C. Animal Producer Considerations
D. Any Issues That Need Further Discussion
E. Summary
Done at Washington, DC, on: August 28, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-21671 Filed 8-29-95; 11:04 am]
BILLING CODE 3410-DM-P
