[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]



 ========================================================================
 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.
 
 ========================================================================
 

  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.

-----------------------------------------------------------------------

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