Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
Federal RegisterJul 25, 1996
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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
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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 t
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