[Federal Register: July 25, 1996 (Volume 61, Number 144)]
[Rules and Regulations]
[Page 38805-38855]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy96-19]
[[Page 38805]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 304, et al.
Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP)
Systems; Final Rule
[[Page 38806]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417
[Docket No. 93-016F]
RIN 0583-AB69
Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule with request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is establishing
requirements applicable to meat and poultry establishments designed to
reduce the occurrence and numbers of pathogenic microorganisms on meat
and poultry products, reduce the incidence of foodborne illness
associated with the consumption of those products and provide a new
framework for modernization of the current system of meat and poultry
inspection. The new regulations (1) require that each establishment
develop and implement written sanitation standard operating procedures
(Sanitation SOP's); (2) require regular microbial testing by slaughter
establishments to verify the adequacy of the establishments' process
controls for the prevention and removal of fecal contamination and
associated bacteria; (3) establish pathogen reduction performance
standards for Salmonella that slaughter establishments and
establishments producing raw ground products must meet; and (4) require
that all meat and poultry establishments develop and implement a system
of preventive controls designed to improve the safety of their
products, known as HACCP (Hazard Analysis and Critical Control Points).
DATES: Effective Date: July 25, 1996, however these rules are not
applicable until the dates listed below.
Applicability dates: (1) The HACCP regulations set forth in 9 CFR
Part 417 and related provisions set forth in 9 CFR 304, 327, and 381
parts will be applicable as follows:
<bullet> In large establishments, defined as all establishments
with 500 or more employees, on January 26, 1998.
<bullet> In smaller establishments, defined as all establishments
with 10 or more employees but fewer than 500, on January 25, 1999.
<bullet> In very small establishments, defined as all
establishments with fewer than 10 employees or annual sales of less
than $2.5 million, on January 25, 2000.
(2) The Sanitation SOP's regulations set forth in 9 CFR 416 will be
applicable on January 27, 1997.
(3) The E. coli process control testing regulations set forth in 9
CFR 310.25(a) and 381.94(a) will be applicable on January 27, 1997.
(4) The Salmonella pathogen reduction performance standards
regulations set forth in 9 CFR 310.25(b) and 9 CFR 381.94(b) will be
applicable simultaneously with applicability dates for implementation
of HACCP.
Comments: Comments on specified technical aspects of the final
regulations must be received on or before September 23, 1996. With
respect to the HACCP final regulations, FSIS requests comments by
November 22, 1996.
ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, DOCKET #93-016F, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 4352, 1400 Independence
Avenue, S.W., Washington, DC 20250-3700. All comments submitted on this
rule will be available for public inspection in the Docket Clerk's
Office between 8:30 a.m. and 1:00 p.m., and 2:00 p.m. and 4:30 p.m.,
Monday through Friday. The references and baseline surveys cited in
this document are available for inspection in the FSIS Docket Room.
FOR FURTHER INFORMATION CONTACT: (1) GENERAL: Dr. Judith A. Segal,
Director, Policy, Evaluation, and Planning Staff, (202) 720-7773; (2)
MICROBIAL TESTING: Patricia F. Stolfa, Acting Deputy Administrator,
Science and Technology, (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Obtaining Copies of This Document:
An electronic version of this document is available on the Internet
from the Federal Register at www.access.gpo.gov/su__docs/aces/
aces140.html. Paper or diskette copies of this document may be ordered
from the National Technical Information Service (NTIS), U.S. Department
of Commerce, 5285 Port Royal Road, Springfield, VA 22161. For a
complete copy of this document orders must reference NTIS accession
number PB96-177613 (paper copy) and PB96-502166 (disk copy). For a copy
of the preamble and rule, the individual appendices, and the impact
assessment reference the following NTIS accession numbers: PB96-177621
(preamble and rule only), PB96-177639 (Appendix A), PB96-177647
(Appendix B), PB96-177654 (Appendix C), PB96-177662 (Appendix D), PB96-
177670 (Appendix E), PB96-177688 (Appendix F), PB96-177696 (Appendix
G), and PB96-177704 (impact assessment). For telephone orders or more
information on placing an order, call NTIS at (703) 487-4650 for
regular service or (800) 553-NTIS for rush service. Dial (703) 321-8020
with a modem or Telnet fedworld.gov to access this document
electronically for ordering and downloading via FedWorld. For technical
assistance to access FedWorld, call (703) 487-4608.
Table of Contents
I. Background
Overview of FSIS Food Safety Goal and Strategy
FSIS Regulatory Proposals
FSIS Regulatory and Inspection Reform Plans
Change Within FSIS
The FSIS Pathogen Reduction/HACCP Rulemaking Process
Seven Information Briefings
Three Scientific and Technical Conferences
Public Hearing
Federal-State Relations Conference
Scoping Session and Six Issue-Focused Meetings
Food Safety Forum
Farm-to-Table Strategy
General Overview of the Comments and the Final Rule
HACCP and Performance Standards
Sanitation SOP's, Antimicrobial Treatments, and Cooling
Requirements for Raw Meat and Poultry Products
Timetable for Implementation
Federally Inspected Establishments
State-inspected Establishments
Foreign-inspected Establishments
Implementation Conferences
Request for Comments
II. Hazard Analysis and Critical Control Point Systems
Overview of Final Rule
History and Background of HACCP
The Seven HACCP Principles
HACCP and the FSIS Food Safety Strategy
Preparing for HACCP Implementation
Inspection under HACCP
Implementation Schedule
Small Business Issues
Training Considerations
Mandatory versus Voluntary HACCP
HACCP from Farm-to-Table
Total Quality Control (TQC) Establishments and HACCP
Freedom of Information Act Concerns
FSIS Enforcement Authority and Whistleblower Protection
Enforcement and Due Process
The Final Rule
Reorganization of HACCP Regulatory Text
HACCP Systems as a Condition of Receiving Inspection
Definitions
Hazard Analysis and HACCP Plan
Corrective Actions
Validation, Verification, and Reassessment
Reassessment
FSIS Verification
Records
[[Page 38807]]
Training
Adequacy of HACCP Plans
III. Sanitation Standard Operating Procedures
The Proposed Rule
The Final Rule
Comments and Responses
General
Development of Sanitation SOP's
Maintaining Sanitation SOP's
Recordkeeping
``Layering''
Role of Inspectors
Relation to HACCP
Training
Pre-operation Sanitation Inspection
Implementation Date
IV. Microbiological Performance Criteria and Standards
Summary of Proposal
Role of Microbiological Performance Criteria and Standards in
FSIS Food Safety Strategy
Overview of Final Rule
Process Control Verification Performance Criteria
Pathogen Reduction Performance Standards
Process Control Verification: E. coli Performance Criteria and
Testing
Rationale for Using E. coli Tests to Verify Process Control
Use of Baseline Values to Establish E. coli Performance Criteria
Establishment of E. coli Performance Criteria to Verify Process
Control
Sampling Frequency for E. coli Testing
Sampling and Analytical Methodology
Recordkeeping
Use of E. coli Test Results by Establishments
Use of E. coli Test Results by FSIS
Implementation Timetable
Request for Comments
Pathogen Reduction Performance Standards
Rationale for Selecting Salmonella
Basis for Performance Standards and Plans for Future Adjustments
Determining Compliance with the Standard
FSIS Testing Strategy
FSIS Testing Methods
FSIS Enforcement Strategy
Implementation Timetable for Pathogen Reduction Performance
Standards
Response to Comments
The Indicator Organism
Frequency and Cost of Testing
Legal Authority for Testing Requirement
Performance Standards for Process Control
Basis for Target Levels
Methodology for Meeting Targets
Sample Size
Testing Methodology
Role of Inspectors
Laboratories
Alternative Sampling under HACCP
Relationship to HACCP
V. Other Issues and Initiatives
Antimicrobial Treatments
Cooling and Chilling Requirements for Raw Meat and Poultry
International Trade
Recordkeeping and Record Retention
Finished Product Standards for Poultry Carcasses
VI. Economic Impact Analysis and Executive Orders
Executive Order 12866
HACCP-based Regulatory Program Produces Net Benefit to Society
Market Failure Justifies Regulation of Pathogens
Regulatory Alternatives
Unfunded Mandates Reform Act
Regulatory Flexibility Act
Executive Order 12778
Paperwork Requirements
Sanitation Standard Operating Procedures (Sanitation SOP's)
Time and Temperature
Microbiological Testing
HACCP
VII. Final Rules
VIII. Appendix A--Guidelines for Developing a Standard Operating
Procedure for Sanitation (Sanitation SOP's) in Federally Inspected
Meat and Poultry Establishments
IX. Appendix B--Model of a Standard Operating Procedure for
Sanitation
X. Appendix C--Guidebook for the Preparation of HACCP Plans
XI. Appendix D--Hazards and Preventive Measures Guide
XII. Appendix E--FSIS Sample Collection Guidelines and Procedure for
Isolation and Identification of Salmonella from Raw Meat and Poultry
Products
XIII. Appendix F--Guidelines for Escherichia coli Testing for
Process Control Verification in Cattle and Swine Slaughter
Establishments
XIV. Appendix G--Guidelines for Escherichia coli Testing for Process
Control Verification in Poultry Slaughter Establishments
XV. Supplement--Final Regulatory Impact Assessment
I. Background
Overview of FSIS Food Safety Goal and Strategy
The mission of the FSIS is to ensure that meat, poultry, and egg
products are safe, wholesome, and properly marked, labeled, and
packaged. Regarding meat and poultry, FSIS currently carries out its
food safety responsibility primarily by managing an inspection program
within meat and poultry slaughter and processing establishments. This
program relies heavily on FSIS inspectors to detect and correct
establishment sanitation and food safety problems.
Recent outbreaks of foodborne illness and studies conducted over
the past decade by the National Academy of Sciences (NAS), the U.S.
General Accounting Office (GAO), and FSIS itself have established the
need for fundamental change in the FSIS meat and poultry inspection
program to improve food safety, reduce the risk of foodborne illness in
the United States, and make better use of the Agency's resources.
FSIS has embarked on a broad effort to bring about the necessary
changes in its program. In the preamble to the ``Pathogen Reduction;
Hazard Analysis Critical Control Point (HACCP) Systems'' proposed rule,
published in the Federal Register of February 3, 1995 (Docket #93-016P,
60 FR 6774; hereafter ``Pathogen Reduction/HACCP proposal''), FSIS
traced the origins of its current program, described today's food
safety challenges, and outlined a new food safety strategy for meat and
poultry products. In that document, FSIS proposed new regulations to
mandate adoption within meat and poultry establishments of HACCP, a
science-based process control system for food safety.
The HACCP requirement and other food safety measures proposed by
FSIS in the Pathogen Reduction/HACCP proposal were motivated by the
critical need to fill a gap in the current regulation and inspection
system and the lack of adequate measures to address the problem of
pathogenic microorganisms on raw meat and poultry products.
Such bacteria, including Salmonella, E. coli O157:H7, Campylobacter
and Listeria monocytogenes, are significant food safety hazards
associated with meat and poultry products. FSIS estimates that the
contamination of meat and poultry products with these bacteria results
annually in as many as 4,000 deaths and 5,000,000 illnesses.
FSIS stated the goal of its food safety strategy and proposed
Pathogen Reduction/HACCP regulations as follows: FSIS believes its
food safety goal should be to reduce the risk of foodborne illness
associated with the consumption of meat and poultry products to the
maximum extent possible by ensuring that appropriate and feasible
measures are taken at each step in the food production process where
hazards can enter and where procedures and technologies exist or can
be developed to prevent the hazard or reduce the likelihood it will
occur (60 FR 6785).
In establishing this goal, FSIS recognized that no single
technological or procedural solution exists for the problem of
foodborne illness and that the Agency's food safety goal would be
achieved only through continuous efforts to improve hazard
identification and prevention.
The food safety strategy FSIS outlined in the Pathogen Reduction/
HACCP proposal included the following major elements: (1) provisions
for systematic prevention of biological, chemical, and physical hazards
through adoption by meat and poultry establishments of science-based
process control systems;
[[Page 38808]]
(2) targeted efforts to control and reduce harmful bacteria on raw meat
and poultry products; (3) adoption of food safety performance standards
that provide incentives for innovation to improve food safety and to
provide a measure of accountability for achieving acceptable food
safety results; (4) removal of unnecessary regulatory obstacles to
innovation; and (5) efforts to address hazards that arise throughout
the food safety continuum from farm to table.
FSIS also stressed, as a central theme of its strategy, a need to
clarify and strengthen the responsibilities of establishments for
maintaining effective sanitation, following sound food safety
procedures, and achieving acceptable food safety results.
FSIS Regulatory Proposals
FSIS proposed HACCP as the organizing structure for its food safety
program because HACCP is the optimal framework for building science-
based process control to prevent food safety hazards into food
production systems. HACCP also focuses FSIS inspection on the most
significant hazards and controls.
To complement HACCP, FSIS proposed to establish, for the first
time, food safety performance standards for pathogenic microorganisms
on raw meat and poultry products, initially as ``interim'' targets for
the reduction of Salmonella contamination of raw carcasses and raw
ground meat and poultry products. These performance standards would
measure whether HACCP systems are working effectively to address food
safety hazards. FSIS proposed to require that establishments conduct
daily microbial testing for Salmonella to verify achievement of the
``targets.''
FSIS also proposed three near-term measures to speed progress on
controlling and reducing pathogenic microorganisms on raw products
during the proposed three year phase-in of HACCP. These proposed
measures were: (1) a requirement that all establishments adopt and
implement sanitation standard operating procedures (Sanitation SOP's);
(2) a requirement that all slaughter establishments use at least one
effective antimicrobial treatment to reduce harmful bacteria; and, (3)
standards for cooling red meat carcasses to prevent the growth of
harmful bacteria.
FSIS Regulatory and Inspection Reform Plans
In the Pathogen Reduction/HACCP proposal, FSIS acknowledged that it
must do more than mandate HACCP and other new regulatory requirements
in order to achieve its food safety goals. FSIS must also reform its
existing regulations, policies, and directives to be consistent with
HACCP principles and with the Agency's intention to rely more heavily
on performance standards. Current FSIS regulatory requirements and
procedures are generally highly detailed and prescriptive. They
specify, for example, precise cooking time-and-temperature combinations
for many products. Current regulations often assign to FSIS
responsibility for the means used by establishments to produce safe
food in a sanitary environment (e.g., FSIS requires that facility
blueprints and equipment receive Agency approval before use).
As part of its regulatory reform initiative, FSIS has undertaken
the conversion of current command-and-control regulations to
performance standards. Command-and-control regulations, and the
Inspection System Guide that FSIS inspectors use to enforce those
regulations, resulted from the perceived need to achieve uniformity
among federally inspected meat and poultry establishments.
Technological advances introduce a new imperative, however. If
establishments are to innovate, using new technologies to improve food
safety, they cannot be impeded by a one-size-fits-all regulatory
system. Under contemporary conditions, affording establishments the
flexibility to make establishment-specific decisions outweighs the
advantages of uniformly applicable rules. Recognizing this, FSIS is
changing inspection to meet the needs of the new regulatory system.
Under the command-and-control-based system, the inspector assumed
responsibility for ``approving'' production-associated decisions. Under
the new system, industry assumes full responsibility for production
decisions and execution. FSIS, having set food safety standards,
monitors establishments' compliance with those standards and related
requirements and under HACCP, verifies process control and pathogen
reduction and control. The number of inspection tasks will be reduced,
so that inspectors can focus more attention on areas of greatest risk
in the meat or poultry production system within each establishment.
With the shift to HACCP and greater reliance on performance
standards, establishments will be afforded greater autonomy in
decision-making affecting their own operations and, in return, be
expected to take responsibility for setting up site- and product
appropriate process control measures to achieve FSIS-established
performance standards. This approach, which is intended to increase
both the incentives and the flexibility establishments need to innovate
and improve food safety, requires a complete review and overhaul of the
``command-and-control'' requirements and procedures in current FSIS
regulations, policies, and directives.
HACCP-based food safety strategies and performance standards also
require important changes in FSIS's approach to inspection. FSIS
intends to clarify the respective responsibilities of FSIS inspectors
and establishment management.
In the Federal Register of December 29, 1995 (60 FR 67469), FSIS
published an advance notice of proposed rulemaking (ANPR) and
additional rulemaking proposals describing the Agency's strategy for
the regulatory and inspectional reform required to achieve the changes
required for consistency with HACCP. These changes will be accomplished
before establishments are required to implement HACCP.
Change Within FSIS
Finally, achieving the Agency's food safety goals will require
substantial change within FSIS itself, as the roles of establishments
and Federal inspectors are realigned to accord with the HACCP
philosophy. The scope of FSIS's food safety activities will also extend
beyond slaughter and processing establishments to include new
preventive approaches to hazards that occur during transportation,
distribution, and retail, restaurant or food service sale of meat and
poultry products.
This expansion of the Agency's roles will require substantial
training and redeployment of employees, and will place an enormous
strain on agency resources. To meet these challenges, FSIS has
conducted a top-to-bottom review of its regulatory roles, resource
allocation and organizational structure. Reports prepared by FSIS
employees containing analysis and recommendations on these topics were
described and made available for public comment in the Federal Register
of September 12, 1995 (60 FR 47346). FSIS will be making the
fundamental internal changes required to successfully carry out its
HACCP-based farm-to-table food safety strategy. These changes within
FSIS, which include a major reorganization of the Agency, will ensure
that FSIS is using its resources to improve food safety consistent with
its new regulatory framework.
[[Page 38809]]
The FSIS Pathogen Reduction/HACCP Rulemaking Process
Recognizing that HACCP and other regulatory requirements contained
in the Pathogen Reduction/HACCP proposal are part of a broad overhaul
of the FSIS regulatory program, and involve important changes in the
responsibilities of meat and poultry establishments, FSIS has conducted
a thorough and interactive rulemaking process. The Agency's goal has
been to provide many opportunities for submission by the public of both
written and oral comments and for interchange between FSIS and
interested parties on the many major policy and technical issues
involved in the reform of meat and poultry inspection.
The initial comment period was 120 days, which FSIS subsequently
extended for an additional 30 days and later reopened for another 95
days. During this period, FSIS held seven informational briefings,
three scientific and technical conferences, a two-day public hearing, a
scoping session and six issue-focused public meetings, a Federal-State
conference, and a Food Safety Forum. Extensive oral comments were
transcribed and included with written comments in the record of this
rulemaking. A brief summary of the various public meetings follows.
Seven Information Briefings
Initially, FSIS held informational briefings in seven cities across
the country to explain the Pathogen Reduction/HACCP proposal to the
public and to answer questions. A panel of FSIS officials and
scientists provided information on the proposed regulations and
answered questions. These briefings were not intended to solicit
comments, but to help interested parties prepare themselves to comment
on the Pathogen Reduction/HACCP proposal. These briefings were held:
March 7, 1995; Oakland, California
March 14, 1995; Dallas, Texas
March 16, 1995; Chicago, Illinois
March 21, 1995; Atlanta, Georgia
March 23, 1995; New York, New York
March 30, 1995; Washington, D.C.
May 22, 1995; Kansas City, Kansas
The Kansas City session included an informational briefing and
public meeting for owners and representatives of small meat and poultry
establishments and other affected small businesses to discuss the
Pathogen Reduction/HACCP proposal. At the meeting, many small business
owners said that the Pathogen Reduction/HACCP proposal might eventually
inhibit small businesses from competing with larger entities because
the resulting additional costs could be borne more easily by larger
companies. Three Directors of State Meat and Poultry Inspection
Programs stated their views that the Pathogen Reduction/HACCP proposal
might have a negative impact upon the small businesses for which they
provide inspection. Consumers requested that FSIS base its decisions on
the Pathogen Reduction/HACCP proposal not on industry impacts, but on
what will best protect the public.
Three Scientific and Technical Conferences
FSIS held three scientific and technical conferences to foster the
development of beneficial new food safety technologies, to fill gaps in
scientific knowledge, and to ensure that the Agency had the best
scientific information available for the rulemaking. Concerned that the
typical rulemaking process would not elicit this information, the
Agency invited experts on relevant subjects to the meetings, which were
open to all interested parties.
The first conference, titled ``New Technology to Improve Food
Safety,'' was held April 12-13, 1995, in Chicago, Illinois. This
conference explored the available technology that might be introduced
into the production and manufacturing of meat and poultry products to
control E. coli O157:H7 and other harmful pathogens in the food supply.
Participants included members of industry, academia, research
organizations, and consumers. Additionally, Government representatives
from non-food Federal regulatory agencies discussed technology
development and transfer in other industries. FSIS discussed how it
emphasized and encourages the approval and introduction of new
technologies.
The second conference, titled ``The Role of Microbiological Testing
in Verifying Food Safety,'' was held May 1-2, 1995, in Philadelphia,
Pennsylvania. This meeting explored scientific issues related to the
use of microbiological testing for verifying meat and poultry safety.
Six persons were invited to present discussions relating to the use and
limitations of microbiological testing in ensuring food safety. Twelve
representatives from academia, consumer groups, industry, and exporting
countries also presented talks on the concepts and methods for
microbiological testing that appeared in the proposed regulation.
During the comment period following the presentations, 15 people
commented on the subjects covered at the meeting and in the proposed
regulation.
The third conference, titled ``An Evaluation of the Role of
Microbiological Criteria in Establishing Food Safety Performance
Standards in Meat and Poultry Products,'' was held May 18-19, 1995, in
Washington, D.C. It explored the use of microbiological criteria to
establish food safety performance standards for meat and poultry
products. Participants generally agreed that HACCP is an effective
approach to controlling microbiological hazards in foods, and that
government and industry must work together to establish microbiological
criteria, sampling plans and training for food safety performance
standards. Most commenters agreed that the use of an indicator organism
is effective to facilitate and monitor the reduction of microbiological
contamination in meat and poultry products. Diverse opinions were
expressed on which indicator organisms should be chosen for each type
of product.
Public Hearing
On May 30 and 31, 1995, FSIS held a public hearing in Washington,
D.C., on the proposed rule.
Thirty-seven persons presented comments at the 2-day hearing.
Issues and viewpoints varied greatly. For instance, requests were made
to keep carcass-by-carcass inspection, but it was suggested that
organoleptic inspection is outdated. While there was support for a
HACCP system, many suggestions were made for changes in specific parts
of the proposal, particularly microbial testing and antimicrobial
treatments. Several commenters described their personal experiences
with foodborne illness. Small business owners and their representatives
commented on the potential financial burdens that might result from the
Pathogen Reduction/HACCP proposal.
Federal-State Relations Conference
As part of the annual meeting of Directors of State Meat and
Poultry Inspection Programs, FSIS held a ``Federal-State Relations
Conference,'' August 21-23, 1995, in Washington, D.C. This meeting, in
which the National Association of State Departments of Agriculture
participated, provided an opportunity for representatives from State
government to engage in an open exchange with senior USDA officials on
the Pathogen Reduction/HACCP proposal. In addition to State Directors,
the meeting included representatives from State Departments of
Agriculture, State Health Departments and local food safety enforcement
agencies; additionally, the Food and Drug Administration (FDA)
[[Page 38810]]
and the Association of Food and Drug Officials were participants. These
parties recognized a need to better protect the public by optimizing
the use of available resources. State agency representatives discussed
the need for better coordination within their own States and with the
Federal Government to prevent foodborne illness outbreaks. Improved
food handling education for industry and consumers was seen as one of
the primary ways to improve farm-to-table food safety.
Scoping Session and Six Issue-Focused Meetings
By late August, FSIS had received more than 6,800 comments on the
Federal Register notice, in addition to the input obtained at the
meetings and the hearing. All this information raised new issues and
modified Agency thinking in some areas. In order to share new
information and current thinking with its constituencies, FSIS held six
issue-focused public meetings on the proposed rule and accepted written
comments from those unable to attend. The meetings were announced in
the Federal Register (60 FR 45380; Thursday, August 31, 1995) and held
at USDA, Washington, D.C., on September 13, 14, 15, 27, 28, and 29,
1995.
FSIS framed an agenda for the meetings and provided issue papers
describing current Agency thinking on the proposed rule. Before the
issue-focused public meetings, FSIS held a public scoping session on
August 23, 1995, to ensure that all parties had an opportunity to
suggest issues for the agenda.
The issue papers provided at the six issue-focused public meetings
were published in the Federal Register (60 FR 54450; Tuesday, October
24, 1995).
Food Safety Forum
A Food Safety Forum chaired by Secretary Glickman was held on
November 8, 1995 to discuss food safety reform issues beyond the
specific issues raised by the proposed Pathogen Reduction/HACCP
proposal. The forum agenda included topics such as: (1) whether
legislative changes to the Federal Meat Inspection Act (FMIA) and the
Poultry Products Inspection Act (PPIA) were needed; (2) how FSIS could
improve food safety by organizational change, regulatory reform,
reliance on user fees, effective resource allocation and other means;
(3) cooperation between USDA and State inspection programs; and (4)
government and private sector roles in consumer education regarding
safe food handling practices. A transcript of the forum has been
included in the record for this rulemaking.
Farm-to-Table Strategy
In the preamble to its Pathogen Reduction/HACCP proposal, FSIS
presented a strategy for the control of food safety hazards throughout
the continuum of animal production and slaughter, and the processing,
distribution, and sale of meat and poultry products. FSIS has
historically focused on the manufacturing of meat and poultry products
through its inspection program, but the Agency's public health mandate
requires that the Agency also consider pre- and post-processing hazards
as part of a comprehensive strategy to prevent foodborne illness.
This farm-to-table food safety strategy is founded on three
principles:
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> Development of the HACCP plan as required by
Sec. 417.2(b);
<bullet> Reassessment and modification of the HACCP plan as
required by Sec. 417.3 and/or Sec. 417.4(a)(3).
The rule has been modified to set a basic standard for HACCP
training while preserving the flexibility needed by industry to
implement HACCP systems effectively. The provisions of Sec. 417.7 are
consistent with FSIS's view that training is central to the success of
HACCP, that there are many avenues for HACCP training needs, and that
responsible establishment officials are in the best position to
determine the training needs for each establishment.
Adequacy of HACCP Plans
The proposed rule stated that a HACCP plan could be found invalid
if it does not meet the regulatory requirements, if HACCP records are
not being maintained to validate the plan or verify process control
under the plan, or if a processing failure results in production of
adulterated product.
The provisions of the final rule relating to the criteria for
finding a HACCP plan inadequate are essentially the same as in the
proposal, except that the term ``invalid'' has been replaced with
``inadequate'' for clarity. Also, the final rule states that a HACCP
plan may be found to be inadequate if establishment personnel are not
performing tasks specified in the HACCP plan. One change from the
proposal concerns the correction of HACCP systems found inadequate
because of product adulteration. Under the proposed
Secs. 326.7(c)(3)(ii) and 381.607(c)(3)(ii), the establishment would
have been required to submit to FSIS, among other things, a written
plan for chemical or microbiological testing by an external laboratory
of finished product produced under the modified HACCP plan to show that
the modified plan corrected the problem. The final rule is more
flexible because decisions regarding the appropriateness of the HACCP
system modifications are made by the establishment.
FSIS will verify that HACCP plans are adequate. The procedure for
determining the adequacy of the HACCP plan will not be a one-step
process. Instead, FSIS will take a variety of actions including
reviewing the HACCP plan and associated records, directly observing the
HACCP system in operation, and assessing the adequacy of corrective
actions. After a thorough review is conducted, FSIS will determine
whether a HACCP plan is adequate. If a plan is found to be inadequate,
FSIS will take appropriate regulatory action.
III. Sanitation Standard Operating Procedures
The Proposed Rule
FSIS proposed that all meat and poultry establishments be required
to develop, maintain, and adhere to written sanitation standard
operating procedures (Sanitation SOP's). The proposal was based on
FSIS's belief that effective establishment sanitation is essential for
food safety and to successful implementation of HACCP. Insanitary
facilities or equipment, poor food handling practices, improper
personal hygiene, and similar insanitary practices create an
environment conducive to contamination of products. There are direct
and substantial links between inadequate sanitation and the
contamination of meat and poultry products by pathogenic bacteria. FSIS
tentatively concluded that Sanitation SOP's were necessary because they
would clearly define each establishment's responsibility to
consistently follow effective sanitation procedures and would
substantially minimize the risk of direct product contamination and
adulteration.
FSIS also had determined that Sanitation SOP's would improve the
utilization of FSIS Inspection Program resources by refocusing FSIS
sanitation inspection on the oversight of establishment prevention and
correction of conditions that cause direct product contamination or
adulteration. After Sanitation SOP's were in place, Agency inspection
personnel would spend less time enforcing detailed sanitation
requirements and directing the correction of problems after they occur.
Instead, FSIS inspectors would focus on oversight of an establishment's
implementation of Sanitation SOP's and on taking appropriate regulatory
action when an establishment's Sanitation SOP's were not properly
executed or when product contamination or adulteration was imminent,
directly observed, or probably had occurred.
The concepts underlying the proposed requirements for Sanitation
SOP's are important and new. In the past, FSIS has not clearly
articulated the responsibility every establishment has to ensure that
sanitation requirements are met every day, both before and during
operations. Although the majority of meat and poultry establishments
maintain adequate sanitary conditions, some establishments have
significant sanitation problems that can be resolved only through more
clearly defining establishment responsibility and accountability for
the daily observance of sound sanitation practices.
The proposed requirements for Sanitation SOP's were the result of
many years of observations by FSIS of establishment sanitation and
management practices. The persistence of insanitary conditions within
some meat and poultry establishments was documented in the ``1,000
Plant Review,'' conducted by FSIS between September 1993 and February
1995. This project involved unannounced visits to 1,014 inspected
establishments during which operations were observed and deficiencies
noted. More than 60 percent of all deficiencies documented by the
review involved establishment sanitation. The distribution of
sanitation problems was not, however, uniform in the establishments
sampled. Fewer than half those establishments visited accounted for 90
percent of the sanitation deficiencies. Data collected through FSIS's
Performance Based Inspection System similarly documents that sanitation
is the most frequent deficiency noted by inspection personnel in
routine establishment visits.
[[Page 38830]]
Through analysis of this information, FSIS determined that the
difference between establishments with consistently sanitary conditions
and those with chronic sanitation deficiencies is often that the better
performing establishments have effective quality control and sanitation
programs, including written Sanitation SOP's, while the marginal
establishments do not. As a means of bringing all establishments to a
consistently acceptable level of sanitation, as well as to clarify the
respective roles of establishments and FSIS in achieving that goal in
each establishment, FSIS proposed that every meat and poultry
establishment develop, maintain, and adhere to written Sanitation
SOP's.
FSIS proposed that Sanitation SOP's cover the daily preoperational
and operational sanitation procedures that the establishment would
implement to prevent direct product contamination or adulteration.
Additionally, establishments would be required to identify the
establishment officials who would monitor daily sanitation activities,
evaluate whether the Sanitation SOP's are effective, and take
appropriate corrective action when needed. Also, each establishment
would be required to make daily records showing completion of the
procedures in the Sanitation SOP's, any deviations and corrective
actions taken, and maintain those records for a minimum of six months.
Further, an establishment's Sanitation SOP's and records were to be
made available to FSIS for verification and monitoring. Finally, the
proposal provided that any equipment, utensil, room or compartment
found by an inspection program official to be not in compliance with
the Sanitation SOP's or insanitary would be tagged ``U.S. Rejected,''
and could not be used until it had been reinspected and passed.
FSIS solicited comments on the proposed regulatory requirements for
Sanitation SOP's. FSIS also requested comments on how Sanitation SOP's
should clarify the responsibilities of establishments and what role
inspection personnel should play in authorizing daily startup of
operations. Comments also were requested on whether certain Good
Manufacturing Practices (GMP's) or other sanitation practices should be
mandatory elements of the Sanitation SOP's.
The majority of the comments addressing the proposed Sanitation
SOP's provisions expressed support. Many commenters, however, expressed
concern about the lack of detail in the proposal regarding the required
contents of an establishment's Sanitation SOP's and about how
Sanitation SOP's would be enforced by inspectors. The comments, both
written and oral, and FSIS's responses are discussed in the
``Comments'' section, which follows the description of the final rule.
The Final Rule
After careful consideration of the comments, FSIS is promulgating
requirements for Sanitation SOP's, essentially the same as proposed,
though with several changes and additions for both clarity and to grant
establishments greater flexibility in meeting the Sanitation SOP's
requirements.
As proposed, all inspected establishments shall develop, implement,
and maintain written Sanitation SOP's. The Sanitation SOP's shall
describe all procedures and establishment conducts daily to prevent
direct contamination or adulteration of product(s). FSIS has clarified
that Sanitation SOP's also shall specify the frequency with which each
procedure in the Sanitation SOP's is to be conducted and identify the
establishment employee(s) responsible for the implementation and
maintenance of such procedure(s). While the employee responsible for
implementation and maintenance of procedures in the Sanitation SOP's
may be the employee who actually performs such activities, he or she
instead may be the employee in charge of ensuring that the sanitation
procedures are carried out. All that is required is that the Sanitation
SOP's identify the employee(s) responsible for implementation and
maintenance of the procedures in the Sanitation SOP's. The
establishment does not need to necessarily identify the employee(s) who
will actually perform the sanitation procedures. Also, an
establishment's Sanitation SOP's may have more than one employee
responsible for implementation and maintenance of sanitation
procedures. For example, one employee may be responsible for pre-
operational procedures and another may be responsible for operational
procedures. The rule provides such flexibility.
Further, FSIS is clarifying in this final rule that establishments
must explicitly identify pre-operational sanitation procedures in their
written Sanitation SOP's, distinguishing them from sanitation
activities to be carried out during operations. This will assist both
the establishment and FSIS in identifying which sanitation procedures
are to be carried out each day prior to start-up of operations.
FSIS is also requiring that Sanitation SOP's be signed and dated by
``the individual with overall authority on-site or a higher level
official of the establishment,'' and that the signature shall signify
that the establishment will implement the Sanitation SOP's. This new
language grants establishments greater flexibility than did the
proposed requirement that ``the establishment owner or operator'' be
responsible for implementation of Sanitation SOP's. Additionally, this
final rule specifies that Sanitation SOP's must be signed upon
initiation and upon any modification.
As in the proposal, the format and content of Sanitation SOP's are
not specified in the final regulations. Because there are many types of
inspected establishments that will achieve the required sanitary
conditions in different ways, this rule gives establishments
flexibility to customize their sanitation plans. Each meat and poultry
establishment must analyze its own operations and identify possible
sources of direct contamination that must be addressed in its
Sanitation SOP's.
As proposed, each establishment is required to conduct the pre-
operational and operational procedures as specified in the Sanitation
SOP's, monitor the conduct of the procedures, and routinely evaluate
the content and effectiveness of the SOP's and modify the Sanitation
SOP's accordingly. The Sanitation SOP's must be kept current. The
establishment must evaluate and modify Sanitation SOP's as needed in
light of changes to establishment facilities, personnel, or operations
to ensure they remain effective in preventing direct product
contamination and adulteration. As upon initial implementation,
Sanitation SOP's must be dated and signed by the individual with
overall authority on-site or a higher level official of the
establishment following any modification.
Also as in the proposal, FSIS is requiring that each establishment
initiate corrective action when either the establishment or FSIS
determines that Sanitation SOP's or their implementation may have
failed to prevent direct product contamination or adulteration. The
requirements regarding corrective actions have been more thoroughly
explained, however, and now specify that corrective actions shall
include ``procedures to ensure appropriate disposition of product(s)
that may be contaminated, restore sanitary conditions, and prevent the
recurrence of direct contamination or adulteration of product(s),
including
[[Page 38831]]
appropriate reevaluation and modification of the Sanitation SOP's and
the procedures specified therein.''
This final rule also adopts the provision in the proposal requiring
establishments to keep daily records documenting that sanitation and
monitoring procedures listed in the Sanitation SOP's are performed.
Establishments also must maintain records documenting any corrective
actions taken to prevent direct contamination or adulteration of
products, or when the establishment determines or FSIS notifies the
establishment that its Sanitation SOP's are inadequate. FSIS has
clarified that such records must be initialed and dated by the
designated establishment employee(s) responsible for the implementation
and monitoring of the Sanitation SOP's procedures.
In response to comments, FSIS has revised the recordkeeping
requirements to allow for computer maintenance of records, as long as
establishments implement controls to ensure the integrity of the
electronic data. FSIS recognizes that many establishments currently use
computers for maintaining a variety of types of information, including
sanitation data. It would be impractical and burdensome to prohibit
these establishments, or others wishing to use computers, from using
computers to record and store required sanitation data.
FSIS proposed that establishments must maintain sanitation records
for a minimum of six months, but did not specify whether these records
had to be stored on-site. Several commenters expressed concern about
the physical location of establishment sanitation records and
questioned whether sanitation records must be maintained in the
establishment.
FSIS requires unimpeded access to all establishment sanitation
records for oversight and enforcement purposes; these records are to be
an integral part of the Agency's inspection activities. FSIS
anticipates that, for most establishments, these records will not be
voluminous and will not create a significant storage problem. However,
the Agency recognizes that space may be limited at certain inspected
facilities and has revised this requirement to allow establishments to
retain records off-site, provided they are not removed from the
establishment for at least 48 hours following completion and they can
be provided to FSIS personnel within 24 hours of being requested.
In this final rule, FSIS is clarifying that it will verify that the
Sanitation SOP's are being implemented and maintained, and that they
are effective. FSIS inspectors will ensure not only that an
establishment is complying with the requirement to develop, implement,
and maintain Sanitation SOP's, and to maintain daily records for them,
but also that the Sanitation SOP's are in fact working. Inspectors will
review the Sanitation SOP's, the daily records, the conduct of
procedures specified in the Sanitation SOP's, and the sanitary
conditions themselves.
The failure by an establishment to comply with the Sanitation SOP's
regulations may initiate regulatory action. The full array of
compliance tools includes process deficiency reports, tagging of
equipment or areas, retention of product, letters of warning, and
suspension and withdrawal of inspection. The nature of FSIS's response
will depend on the circumstances. Minor omissions or errors in
Sanitation SOP's documentation, not symptomatic of larger ``system''
problems, will result in regulatory action commensurate with the
severity of the violation. For example, process deficiency reports
might be issued to direct corrective action. However, a pattern of
violations of the Sanitation SOP's provisions would lead to additional
responses, with persistent and serious failures resulting in suspension
or withdrawal of inspection from the establishment. Suspensions and
withdrawals would be made in accordance with applicable rules of
practice for those proceedings.
If FSIS determines that an establishment's Sanitation SOP's fail to
include procedures to prevent direct product contamination or
adulteration or that required records are not being kept, the Agency
may tag affected facilities and equipment and suspend inspection until
the failure is remedied. Because the tagging of insanitary facilities
and equipment is based on current statutory authority, the specific
regulatory provisions for tagging in the proposal are not retained in
this final rule.
Verification and compliance activities under the Sanitation SOP's
provisions are distinguishable from actions taken as a consequence of a
finding of product adulteration under the sanitation requirements
elsewhere in the regulations. As a practical matter, however, such
findings are likely to be connected. A finding of deficient Sanitation
SOP's or Sanitation SOP's records may prompt additional inspection
activity directed at determining whether or not product contamination
or adulteration has occurred. If it has, FSIS will take appropriate
action to prevent adulterated product from entering commerce and, where
necessary, seek recall of product that has already entered commerce.
Finally, the Sanitation SOP's requirements of this final rule are
set out in a new Part 416, Sanitation. These provisions are formatted
differently from the proposal to comport with FSIS's announced project
to reform, reorganize, and recodify the meat and poultry regulations.
This regulatory reform project is well underway, and will, among other
things, eliminate unneeded regulations by combining, to the extent
possible, the currently separate meat and poultry regulations. New Part
416, like new part 417 on HACCP, covers both meat and poultry products.
Part 416 will be expanded and supplemented as the Agency proceeds with
its initiative to review, reform, and reorganize existing FSIS
regulations concerning sanitation.
Comments and Responses
General
Support for the proposed requirements for Sanitation SOP's was
expressed by a wide range of commenters. Most supporters agreed that
establishment sanitation is essential to product safety and that every
meat and poultry establishment should be required to have a written
sanitation plan. Those who opposed mandatory Sanitation SOP's argued
that current sanitation regulations would be adequate if they were
better enforced, that Sanitation SOP's would be no more than a
paperwork exercise, and that they would be an additional burden on
establishments. FSIS strongly disagrees with the notion that Sanitation
SOP's will be a mere ``paperwork exercise,'' and believes this
regulation will, in fact, result in improved sanitation and provide for
more effective enforcement of the sanitation requirements.
Substantial evidence exists that insanitary facilities or
equipment, poor food handling, improper personal hygiene, and similar
insanitary conditions create an environment in which products become
contaminated with microorganisms, including pathogens. While sanitation
has improved greatly throughout the industry over the years, some
individual establishments still have difficulty getting their
facilities and equipment ready to start operations each day and keeping
conditions sanitary during establishment operations. FSIS affirms that
proper sanitation is an important and integral part of every food
process and a fundamental requirement of the inspection laws that the
Agency enforces.
[[Page 38832]]
In the past, FSIS has enforced the sanitation requirements
primarily through a combination of prescriptive sanitation regulations,
detailed guidance materials, and direct, hands-on involvement by
inspectors in day-to-day pre-operational and operational sanitation
procedures in inspected establishments. This system achieved sanitation
goals on a daily basis in individual establishments, but at a
relatively large public cost because it encouraged establishments to
shift accountability for sanitation to the FSIS inspector. For example,
in the past, FSIS inspectors have taken responsibility for checking
sanitation in every slaughter establishment before it begins daily
processing. In extreme cases, inspectors have led daily ``bucket
brigades'' of slaughter establishment employees through pre-operational
establishment cleanup. In these circumstances, FSIS has, in effect,
taken responsibility for establishment sanitation conditions. The
Sanitation SOP's requirement is intended to end this practice.
Sanitation SOP's make it clear that responsibility for identifying and
conducting procedures needed to maintain sanitary conditions rests with
the establishment, not with FSIS.
Sanitation SOP's are an inspection tool. They will help individual
inspectors focus their oversight in an establishment on those
conditions that pose a risk of direct product contamination or
adulteration, that is, on conditions which pose the greatest
adulteration hazards to products subject to inspection in that
establishment. The effectiveness of each establishment's Sanitation
SOP's in achieving acceptable sanitation will be subject to continuing
verification by FSIS inspectors through direct observation of
conditions in the establishment. It is expected that, over time,
inspectors in most establishments will increasingly be able to rely on
a review of daily Sanitation SOP's records to determine whether
establishments are complying with sanitation requirements. However,
FSIS inspectors will continue to have a full array of regulatory tools
to ensure the maintenance of sanitary conditions. For instance, FSIS
inspectors will continue tagging equipment, utensils, rooms, or
compartments in instances where there is physical evidence of
insanitary conditions in the production areas of the establishment.
FSIS anticipates that the development, implementation, and
maintenance of Sanitation SOP's, as well as the recordkeeping
provisions, will impose a minimal burden on establishments. Some
establishments already utilize written Sanitation SOP's. For other
establishments, compliance with the Sanitation SOP's requirements will
consist of recording their current sanitation practices. A complete
discussion of the anticipated costs of implementing the SOP's
requirements is contained in the Final Regulatory Impact Analysis.
Sanitation SOP's are an integral part of the Agency's strategy for
making inspection more effective and more risk-based in its focus. For
these reasons, FSIS is adopting the proposed requirements for
Sanitation SOP's and is clarifying that developing, implementing, and
maintaining Sanitation SOP's and keeping daily Sanitation SOP's
records, is a condition of inspection.
Development of Sanitation SOP's
As noted previously, a number of commenters raised concerns about
the content of the Sanitation SOP's and asked for more specificity.
Some commenters recommended that FSIS be more specific about what
procedures must be in the Sanitation SOP's. Other commenters suggested
that such procedures be fully described and be made mandatory. The
Agency recognizes these commenters' concerns and therefore is providing
guidance on how individual establishments may develop their Sanitation
SOP's in Appendix A and Appendix B to this final rule. Appendix A is a
guideline on Sanitation SOP's that establishments can use in developing
their own Sanitation SOP's; Appendix B is a model of an establishment's
Sanitation SOP's that demonstrates what a completed Sanitation SOP's
might include. Together, these guidance documents will assist
establishments to develop Sanitation SOP's that address conditions
unique to individual establishments and processes and that prevent
direct product contamination or adulteration. As with all FSIS guidance
materials, the Agency welcomes comments on how these two documents
might be improved.
However, the final rule itself remains nonprescriptive in that it
requires each establishment to determine for itself what procedures are
necessary to prevent insanitary conditions that will cause direct
product contamination or adulteration. Overall, the comments confirmed
that, while proper sanitation is a common need in every food production
facility, the means to achieve it are diverse and establishment-
specific. Establishments that now have good sanitation and effective
process controls are expected to continue using techniques that work in
their establishment. Other establishments will need to analyze and
select effective abatement procedures among various alternatives for
attaining a sanitary processing environment. What works in one
establishment may or may not work in another.
The proposed rule also solicited comments as to whether FSIS should
mandate Good Manufacturing Practices (GMP's) for all or certain
Sanitation SOP's. FSIS listed illustrations in the proposal of elements
that might be mandatory elements of Sanitation SOP's. Although some
commenters expressed support for making GMP's or other practices
mandatory, many objected to such specific requirements on the basis
that they would be infeasible. FSIS agrees with those commenters who
stated that detailed GMP regulations are infeasible because of the
difficulty in making them specific enough to be useful. FSIS also was
concerned that such specificity could result in lost flexibility.
For these reasons, this final rule will not prescribe a single
format for individual establishment Sanitation SOP's or mandate
specific GMP's. It will be the responsibility of each establishment to
consider existing FSIS regulations and guidelines; evaluate its
facilities, processes, and sanitation conditions; determine what
sanitation procedures must be implemented to prevent direct product
contamination or adulteration; and describe these procedures in
Sanitation SOP's.
Maintaining Sanitation SOP's
FSIS received several comments regarding the maintenance of
Sanitation SOP's. Some commenters wanted to know whether if an
establishment will be able to update its Sanitation SOP's to
incorporate new technologies. Other commenters wanted to know what type
of system, if any, FSIS will use to review changes to Sanitation SOP's
and if a formal request for FSIS review or approval would be required.
As has been discussed previously, the final rule requires that each
establishment develop, implement, and maintain its Sanitation SOP's and
incorporate new sanitation technologies as appropriate. FSIS encourages
the adoption of new technologies that can improve sanitation and food
safety. This is an establishment responsibility. Although FSIS will not
approve Sanitation SOP's, it will provide advice and guidance to
establishments as they develop and begin to implement Sanitation SOP's.
Recordkeeping
Commenters also expressed concerns about what was to be in daily
sanitation
[[Page 38833]]
records and how long and where such records were to be retained. As the
proposal explained, and this final rule requires, Sanitation SOP's
records must document the implementation and maintenance of Sanitation
SOP's, as well as any deviations from Sanitation SOP's procedures, and
corrective actions taken. As with the development of Sanitation SOP's
themselves, FSIS will allow each establishment to determine the form
and format of its daily sanitation records. In many establishments, a
simple, daily checklist, showing that specific Sanitation SOP's
procedures were implemented, initialed by the responsible establishment
employee, is likely to suffice. Other establishments may find a more
detailed format for its records is more useful. Some establishments may
wish to use a computer-based system. This final rule provides such
flexibility.
Some commenters stated that the proposed six-month retention of
daily sanitation records was too long. FSIS disagrees and is adopting
the proposed requirement that establishments retain Sanitation SOP's
records for six months. Increased product shelf-life and the potential
need for FSIS personnel to review Sanitation SOP's records many months
after production make it necessary that establishments retain records
for six months. Furthermore, sanitation records provide both FSIS and
establishment management near-term trend data to evaluate how
establishment sanitation is being carried out under the Sanitation
SOP's. This feedback should be very useful to establishments in
determining whether and how their Sanitation SOP's need revision.
Inspectors will benefit, too, from knowing how the establishment has
complied with these requirements. Establishment sanitation records will
also need to be reviewed by the Agency as part of any compliance
investigation.
In a related matter, several commenters expressed concern about the
physical location of establishment sanitation records and questioned
whether sanitation records must be maintained in the establishment. As
explained above, FSIS requires unimpeded access to all establishment
sanitation records for oversight and enforcement purposes. FSIS
anticipates that, for most establishments, these records will not be
voluminous and will not create a significant storage problem. However,
in response to these comments, this final rule will allow
establishments to retain Sanitation SOP's records off-site provided
they are not removed from the establishment for at least 48 hours
following completion and they can be provided to FSIS personnel within
24 hours of request.
Some commenters also expressed concern about public accessibility
to an establishment's Sanitation SOP's records. Like establishment
HACCP records, these records are kept and maintained by the
establishment and generally are not Agency records. Occasionally,
however, such records will be copied and incorporated into Agency
records for some official purpose. These records will be disclosed to
third parties only to the extent disclosure is required by the Freedom
of Information Act and the Privacy Act or other applicable law.
Proprietary information, personal information, and other information
exempt from disclosure would be protected.
``Layering''
Many commenters were concerned that FSIS was layering requirements
for Sanitation SOP's over existing regulations governing establishment
sanitation practices, thereby increasing rather than decreasing
intrusive, command-and-control oversight of all inspected
establishments. Concern was also expressed that the new requirements
might conflict with current sanitation regulations.
FSIS does not consider the Sanitation SOP's requirement to be
layered over or in conflict with existing regulations. Existing
regulations establish substantive sanitation-related requirements,
while the new Sanitation SOP's provisions establish a means by which
establishments will take responsibility for achieving sanitary
conditions and preventing direct product contamination or adulteration.
Sanitation SOP's also will better focus inspection oversight by FSIS
inspectors on those sanitation measures required to prevent direct
product contamination or adulteration. As discussed, one of the
Agency's goals is to reduce inspectors' personal involvement in the
conduct of routine, day-to-day sanitation procedures.
FSIS emphasizes that it does not intend or require that an
establishment's Sanitation SOP's incorporate all elements of the
existing FSIS sanitation regulations. These regulations contain many
detailed provisions that do not relate to the prevention of direct
product contamination. As the text of the Sanitation SOP's regulations
and the guidance materials at Appendices A and B makes clear, FSIS
intends and requires only that the Sanitation SOP contain a description
of the procedures an establishment will follow to address the elements
of pre-operational and operational sanitation that relate to the
prevention of direct product contamination.
For example, under paragraph (a) of Sec. 308.4 of the regulations,
FSIS requires that ``Dressing rooms, toilet rooms, and urinals shall be
sufficient in number, ample in size, and conveniently located.''
Although compliance with this requirement is important for the
maintenance of establishment sanitation, and employee hygiene must be
part of Sanitation SOP's, Sec. 308.4(a) does not concern direct product
contamination and would not need to be addressed in an establishment's
Sanitation SOP's. On the other hand, the rule requires that Sanitation
SOP's specifically address the pre-operational ``cleaning of food
contact surfaces of facilities, equipment, and utensils'' because these
procedures are necessary to prevent the direct contamination of
product. Additionally, the guidance materials in Appendices A and B
give examples of other procedures necessary to prevent direct product
contamination that Sanitation SOP's should include, such as
``Descriptions of equipment disassembly, reassembly after cleaning, use
of acceptable chemicals according to label directions, and cleaning
techniques.'' FSIS emphasizes, however, that an establishment does not
need to reproduce in its written Sanitation SOP's the existing
regulatory requirements concerning the prevention of direct
contamination or adulteration of product.
FSIS also realizes that its existing sanitation regulations contain
some detailed and prescriptive provisions and that some of those
regulations may be outmoded and no longer needed in light of the
Agency's effort to clarify that good sanitation is the responsibility
of each establishment. FSIS will continue to review, reevaluate, and
revise, as necessary, all current sanitation regulations, along with
related issuances and sanitation inspection procedures, to simplify and
streamline them and make them more compatible with Sanitation SOP's
requirements. This process was announced and initiated in the advance
notice of proposed rulemaking published on December 29, 1995 (60 FR
67469). The review of sanitation regulations is a high priority for the
Agency. The elements of sanitation that are required to be addressed in
the Sanitation SOP's will remain as central elements of the FSIS
sanitation regulations. Establishments will not need to revise their
Sanitation SOP's because of the simplification and streamlining of
existing FSIS sanitation regulations.
[[Page 38834]]
Role of Inspectors
A related concern of many commenters was the role FSIS inspectors
will play in the development and enforcement of Sanitation SOP's. Some
commenters expressed concern that during inspection inspectors would
rely solely on record reviews instead of actually observing
establishment conditions. Other commenters expressed concerns that
Sanitation SOP's would merely provide FSIS inspectors with more
latitude to make intrusive and arbitrary decisions.
FSIS strongly disagrees with this characterization of Sanitation
SOP's and the role of the Agency's inspection personnel. Industry's
responsibility for producing safe meat and poultry and FSIS's
responsibility for regulatory oversight are fundamentally different.
Sanitation SOP's are the establishment's commitment to FSIS that they
will consistently provide a sanitary environment for food production.
FSIS inspectors will not be tasked with directing an establishment's
sanitation procedures, nor with ``approving'' the establishment's
Sanitation SOP's. They will, however, verify that the Sanitation SOP's
are being implemented and that they are effective in preventing direct
product contamination and adulteration.
Oversight of Sanitation SOP's will become an increasingly important
part of daily inspection activity, while the directing of sanitation
activities will occur less frequently. Periodic inspection tasks will
include verifying that Sanitation SOP's meet the regulation's
requirements, are being implemented and maintained, and are effective
in producing sanitary conditions. FSIS inspectors' oversight will
include review of the Sanitation SOP's and required records, direct
observation of the implementation and monitoring of the Sanitation
SOP's, and visual observation of sanitary conditions in the production
areas of the establishment.
FSIS expects that establishments will rely less on inspectors to
direct them in maintaining sanitary conditions as establishments rely
more on adherence to their own Sanitation SOP's. The mix of inspector
tasks that comprise sanitation inspection also will change. As
establishments adopt and successfully implement Sanitation SOP's, and
consistently achieve good sanitation results, FSIS inspectors can spend
less time ensuring that basic sanitation requirements are being met.
Conversely, to the extent some establishments do not implement
effective Sanitation SOP's and consistently achieve good sanitation,
FSIS inspectors will be obliged to intensify their focus on actual
establishment conditions and initiate appropriate enforcement actions.
Ensuring establishments operate under sanitary conditions should be
made easier for inspectors, and ultimately permit inspectors to spend
more time on other tasks. One purpose of the Sanitation SOP's
regulations is to help inspectors, as well as establishments, focus
their attention on those aspects of establishment sanitation that pose
the most risk of causing product contamination or adulteration. Under
the current inspection system, inspectors look at all aspects of
establishment sanitation, including many that have a relatively low
probability of causing product contamination. In the future, normal
oversight activities will focus more on whether an establishment is
following its Sanitation SOP's and thereby consistently preventing, or
as appropriate, correcting, conditions that cause direct product
contamination or adulteration. Some commenters were concerned about the
effect on establishment operations if inspection personnel, when
enforcing the Sanitation SOP's requirements, reject one piece of
equipment, utensil, room or compartment as insanitary. As previously
stated, inspectors will take prompt action in cases where there is a
finding of insanitation or the likelihood of product contamination or
adulteration. The type and intensity of this response will vary. For
example, establishment operations may be allowed to continue if
inspection personnel determine that a rejected item, compartment or
room is not related to other processes or products being produced.
However, inspection would be withheld in rooms, departments, or
facilities associated with the production of contaminated or
adulterated products where the establishment can not show FSIS that
they have isolated the cause of the contamination or adulteration and
have taken appropriate action to prevent further contamination or
adulteration. In a similar vein, commenters also stated that
establishments should not be penalized for the occurrence of a
sanitation problem that is effectively abated. These commenters
suggested that ``U.S. Rejected'' tags should be used only if an
establishment fails to identify and correct insanitary conditions. If
the establishment takes proper corrective action, they argued, it
should be viewed as evidence that the Sanitation SOP's is being
adequately implemented. FSIS agrees. Establishments that identify and
correct insanitary conditions in a timely manner and make proper
disposition of any affected product will be considered to be in
compliance with the Sanitation SOP's regulations.
Although FSIS fully expects that the clarification of
establishments' sanitation responsibilities will lead to better and
more consistent compliance with sanitation requirements, the Agency
recognizes that this will not be the case in all establishments.
Establishments that fail to comply with the requirements in this final
rule for Sanitation SOP's will be subject to appropriate compliance and
regulatory action that will, when necessary, include suspension or
withdrawal of inspection. Further, as noted in the proposal, anyone who
intentionally falsifies records will be subject to criminal
prosecution.
FSIS also recognizes commenters' concerns about its rules of
practice and due process procedures. FSIS expects that these concerns
will be addressed through changes to these procedural requirements
initiated as a result of the Agency's regulatory reform project. These
subjects are also on the agenda for discussion at FSIS's upcoming
implementation conferences.
Relation to HACCP
Another important topic raised by commenters was the link between
an establishment's Sanitation SOP's and its HACCP plan. This link was
unclear to some who stated the two were redundant. HACCP plans aim at
ensuring safety at specific critical control points within specific
processes, while Sanitation SOP's typically transcend specific
processes. Sanitation SOP's are important tools for meeting existing
statutory sanitation responsibilities and preventing direct product
contamination or adulteration. As such, it is appropriate that they be
developed and implemented in the near-term prior to implementation of
HACCP. In a sense, the Sanitation SOP's are a prerequisite for HACCP.
It is anticipated that some procedures addressed in an establishment's
Sanitation SOP's might eventually be incorporated into an
establishment's HACCP plan. Other procedures in an establishment's
Sanitation SOP's, including those addressing pre-operational sanitation
procedures for cleaning facilities, equipment, and utensils, will most
likely remain in the Sanitation SOP's. A sanitation procedure that is
incorporated into a validated HACCP plan need not be duplicated in the
Sanitation SOP's.
[[Page 38835]]
Training
A number of comments expressed concern about the content of
inspector training, suggesting that inadequate training would result in
inconsistent enforcement of the rule. Assurance was requested that
inspectors would be trained to consistently monitor Sanitation SOP's.
FSIS recognizes that inspectors must be trained to react as regulators
rather than as quality control consultants or establishment sanitarians
when a sanitation or other health and safety problem is discovered in
an establishment. A primary focus of agency training sessions will be
to attain this goal.
Also, some commenters asked whether joint FSIS and industry
training would be offered. FSIS does not plan to allow industry to
attend Agency training sessions. However, FSIS does plan to hold
informational briefings for industry personnel. These will be the
subject of future notices in the Federal Register.
Pre-Operation Sanitation Inspection
Some commenters asserted that establishments with good Sanitation
SOP's should be permitted to start daily operations on their own,
instead of having to wait for an inspector to conduct a pre-operational
sanitation inspection and allow operations to start. FSIS agrees with
these commenters. Accordingly, upon the effective date of this rule and
implementation of Sanitation SOP's, establishments not otherwise
notified by FSIS may begin daily processing upon completion of pre-
operational sanitation activities without the prior approval of an
inspector.
Extending the implementation date for Sanitation SOP's will also
give FSIS additional time to provide needed training, instruction and
management support to FSIS inspection personnel tasked with enforcing
the Sanitation SOP's requirements.
Implementation Date
Finally, many commenters expressed concern about the amount of time
they said it would take to prepare and implement effective Sanitation
SOP's. These commenters requested more lead time to implement these
requirements. FSIS agrees that some establishments may need more time
than the 90 days the proposed rule provided for implementing Sanitation
SOP's requirements. Consequently, FSIS is modifying this aspect of the
proposal. This final rule will provide establishments six months from
the effective date of this regulation to develop and implement written
Sanitation SOP's. This additional time will allow these establishments
to initially develop and refine their Sanitation SOP's to best meet
operational needs before the effective date of the Sanitation SOP's
requirements. Extending the implementation date for Sanitation SOP's
will also give FSIS additional time to provide needed training,
instruction, and management support to personnel tasked with enforcing
the Sanitation requirements.
IV. Microbiological Performance Criteria and Standards
Summary of Proposal
As part of the Pathogen Reduction/HACCP proposal, FSIS proposed
interim targets for the reduction of Salmonella for the major species
and for ground meat and poultry. Further, FSIS proposed to require
daily testing by slaughter establishments and establishments producing
raw ground product in order to verify achievement of the Salmonella
targets on an ongoing basis. The proposal reflected a central tenet of
the FSIS food safety strategy: to be effective in improving food safety
and reducing the risk of foodborne illness, HACCP-based process control
must be combined with objective means of verifying that meat and
poultry establishments are achieving acceptable levels of food safety
performance.
FSIS explained in the preamble to the proposal that food safety
performance standards, in the form of tolerances or other limits, have
been an important feature of the food safety regulatory system for
chemical residues (such as those resulting from the use of animal drugs
and pesticides) and for pathogenic microorganisms in ready-to-eat meat
and poultry products (such as Listeria monocytogenes in ready-to-eat
products and Salmonella in cooked beef). However, performance standards
have not in the past been incorporated into the regulatory system for
pathogens on raw meat and poultry products.
FSIS recognizes that establishing performance standards for
pathogens on raw products raises different and difficult issues. The
microbiological safety of a meat or poultry product at the point of
final sale or consumption is affected by many factors. Most
significantly, unlike other kinds of contaminants, microbiological
pathogens can be introduced at many points on the farm-to-table
continuum, and once in the product, under certain conditions, the
bacteria can multiply. Some pathogens, such as E. coli O157:H7, are so
virulent that a small number of organisms can pose a significant
hazard. Indeed, on that basis the Agency has determined that any amount
of E. coli O157:H7 will adulterate a meat or poultry product. On the
other hand, some pathogens, such as Salmonella, ordinarily must
multiply to relatively large numbers to cause illness, although the
susceptibility of individuals to illness varies widely. Certain
segments of the population, such as the very young, the elderly, and
persons with compromised immune systems, are particularly vulnerable to
illnesses caused by Salmonella and other foodborne pathogens.
Therefore, FSIS has not taken the position in this rulemaking that
some amount of a pathogen necessarily renders a raw meat or poultry
product unsafe and legally adulterated; the proposed targets for
pathogen reduction would not have served as a standard for determining
whether any particular lot of raw product could be released into
commerce. The proposed targets were intended instead as an initial step
toward defining levels of food safety performance that establishments
would be required to achieve consistently over time. The interim
targets and the required testing by establishments were also intended
as a first step toward the eventual incorporation of microbial testing
as an integral part of process-control validation and verification in
facilities operating under HACCP.
Salmonella was selected as the target organism because it is the
most common cause of foodborne illness associated with meat and poultry
products. It is present to varying degrees in all major species. And,
interventions targeted at reducing Salmonella may be beneficial in
reducing contamination by other enteric pathogens.
As interim targets for pathogen reduction, FSIS proposed that the
prevalence of Salmonella contamination in each of the major species and
in raw ground products be reduced by each establishment to a level
below the current national baseline prevalence as measured by the FSIS
Nationwide Microbiological Baseline Data Collection Programs and
Nationwide Microbiological surveys (collectively referred to below as
the FSIS baseline surveys) or other available data.
Role of Microbiological Performance Criteria and Standards in FSIS Food
Safety Strategy
As explained in the ``Background'' section of this preamble, the
most important objective of this rulemaking is to build into food
production processes and the FSIS system of regulation and oversight,
effective measures to reduce and control pathogenic microorganisms
[[Page 38836]]
on raw meat and poultry products. FSIS has concluded that HACCP-based
process control combined with appropriate microbiological performance
criteria and standards will achieve this objective.
Because the current regulatory system lacks any performance
criteria or standards for harmful bacteria on raw products (other than
with respect to E. coli O157:H7 on raw ground beef), FSIS inspectors
have no adequate basis for judging whether establishments producing raw
meat and poultry products are dealing effectively with the food safety
hazard posed by harmful bacteria.
The HACCP requirements discussed in the preceding section of this
preamble will ensure that all meat and poultry establishments implement
science-based process controls designed to prevent and reduce the
significant food safety hazards that arise in their particular
production processes and products. For slaughter establishments and
other establishments producing raw meat and poultry products, this will
mean developing controls that address the hazards posed by pathogenic
microorganisms as well as other biological, chemical and physical
hazards. HACCP principles provide the framework by which establishments
target and reduce harmful bacteria on raw meat and poultry products.
To be successful in ensuring food safety, however, HACCP must be
coupled with appropriate performance criteria and standards against
which the effectiveness of the controls developed by each establishment
can be validated and verified. For example, controls designed to
prevent the contamination of processed, ready-to-eat meat and poultry
products with harmful bacteria would have to be validated as effective
in meeting the already-existing requirement that such products be free
of harmful bacteria. Without such performance criteria and standards,
there would be no objective basis for determining whether a particular
HACCP plan is adequate for its food safety purpose. Additionally, there
would be no way to determine whether industry or FSIS had met their
respective food safety responsibilities.
In this rulemaking, FSIS for the first time proposed
microbiological performance standards for raw products. The need for
some measure of performance in the area of microbiological
contamination was generally supported by the comments FSIS received on
its proposal. In response to the comments, FSIS has refined and
improved its proposed approach, and is establishing microbiological
performance standards for reduction of Salmonella in raw products,
coupled with performance criteria for use with E. coli testing to
verify the effectiveness of process controls in slaughter
establishments.
These new provisions are the first steps in what FSIS expects to be
a long-term effort to ensure that appropriate microbial testing is
conducted, and appropriate criteria and standards exist, to reduce the
food safety hazards posed by harmful bacteria on raw meat and poultry
products. The numerical targets for both the performance criteria and
the pathogen reduction performance standards are likely to be changed
as new data become available. The targets currently are set at the
national baseline prevalence of contamination and reflect what is
achievable using available technology. FSIS intends to repeat
periodically its baseline surveys, on which the criteria and standards
are based. FSIS will collect additional data on Salmonella by testing
products in establishments pursuant to the performance standards and on
E. coli through close monitoring of establishments' experience and test
results associated with that mode of process control verification.
These new data, together with relevant epidemiologic data, scientific
research, and new technologies, will be considered by FSIS when
proposing future revisions to the performance criteria and testing
requirements for E. coli and the pathogen reduction performance
standards for Salmonella. New information and data also may support
different standards and different approaches to microbial testing.
FSIS is committed to the development and implementation of future
performance standards, as needed, to achieve the FSIS's public health
goal of reducing the incidence of foodborne illness associated with
harmful bacteria on raw meat and poultry products. FSIS is also
concerned that standards achieve this public health goal in a manner
that encourages industry innovation and minimizes regulatory burdens on
the regulated industry. The pathogen reduction performance standards
promulgated in this regulation will be implemented on the basis of a
statistical evaluation of the prevalence of bacteria in each
establishment's products, measured against the nationwide prevalence of
the bacteria in the same products. These standards will not be used to
judge whether specific lots of product are adulterated under the law.
As more research is done and more data become available, and as more
sophisticated techniques are developed for quantitative risk assessment
for microbiological agents, it may be possible and appropriate to
develop performance standards that use a different approach.
Consideration may also be given to the possibility of establishing
similar standards for other pathogenic microorganisms. FSIS will
continue to work with the scientific community in this area.
The microbiological performance standards set out in this
rulemaking are part of a fundamental shift in FSIS regulatory
philosophy and strategy. The current inspection system relies heavily
on intensive ``command-and-control'' prescription of the means by which
meat and poultry establishments must achieve statutory objectives
concerning food safety, sanitation, product wholesomeness, and
prevention of economic adulteration and misbranding. As explained in
the ``Background'' section of this preamble, in FSIS's ANPR ``FSIS
Agenda for Change: Regulatory Review,'' and in the January, 1996,
National Performance Review report ``Reinvention of Food Regulations,''
FSIS plans to shift from this reliance on command and control
regulations to much greater reliance on performance standards. FSIS
believes that public health and consumer protection goals can be
achieved more effectively, in most cases, by converting command-and-
control regulations to performance standards, which provide industry
with the flexibility to devise the optimal means of achieving food
safety objectives. FSIS would verify compliance with such performance
standards through inspection and other forms of oversight.
Overview of Final Rule
Comments on the proposed rule's microbial testing provisions have
resulted in a number of changes to those provisions. As discussed in
the ``Response to Comments'' section, below, FSIS received numerous
comments supporting the concept of microbiological performance criteria
or standards, but also received many comments urging alternatives to
the specific approach proposed by FSIS, including testing for organisms
other than Salmonella.
The Agency actively sought out comment and information on the issue
of target organism(s) to be selected for process control verification
and pathogen reduction purposes in this regulation. In the proposal,
FSIS stated that ``the Agency recognizes that there are other foodborne
human pathogens of public health concern that can be isolated from raw
meat and poultry product. The Agency would welcome
[[Page 38837]]
comments on the targeting of other pathogens in addition to or in lieu
of Salmonella'' (60 FR 6800). As noted earlier in this preamble, during
the comment period FSIS held many meetings to solicit comment on
various issues, including microbiological criteria and standards.
Microbiological criteria and standards were discussed in detail at the
FSIS-sponsored scientific conference held in Philadelphia,
Pennsylvania, on May 1 and 2, 1995, titled ``The Role of
Microbiological Testing in Verifying Food Safety.'' This conference was
open to the public and was announced in the Federal Register on March
24, 1995 (60 FR 15533). An expert panel at that conference endorsed the
role of microbiological testing in accordance with appropriate criteria
or standards, but suggested that mandatory establishment testing focus
on a quantitative assay for generic E. coli rather than the proposed
qualitative assay for Salmonella. The panel stated that a quantitative
assay for the more commonly occurring generic E. coli is a more
effective process control indicator with respect to the prevention of
contamination of meat and poultry by feces and associated bacteria.
FSIS also held a series of six issue-focused public meetings in
September, 1995. During a preliminary public meeting on August 23,
1995, at which issues were identified and the meeting agenda was
established, participants decided that a full day should be devoted to
further public discussion of pathogen reduction standards and microbial
testing. The agenda for the six meetings appeared in the Federal
Register on August 31, 1995 (60 FR 45381). The issues discussed on
September 27 included: (1) the scientific and policy basis for
establishing targets; (2) whether Salmonella is the appropriate
organism for some or all species; (3) whether other pathogens would be
preferable for some or all animal species; (4) the utility of targets
for E. coli or other non-pathogenic indicator organisms as a means of
controlling and reducing pathogenic microorganisms; (5) the advantages
and disadvantages of targets based on the prevalence of detectable
contamination vs. targets based on the number of organisms present; and
(6) the need for pathogen reduction targets for raw ground products in
general and in establishments that both slaughter animals and produce
ground product.
At the September 27, 1995, issue-focused meeting, there was
additional comment in favor of testing for an organism other than
Salmonella, such as generic E. coli, that has a strong track record in
the industry as a good organism to use for process control verification
testing. There was, however, continued strong support for raw product
testing targeted at pathogens, such as Salmonella, and support for
pathogen reduction as the primary goal of such testing.
At the meetings, FSIS distributed issue papers on the various
issues being addressed, based in large part on comments already
received. The issue paper on Pathogen Reduction Performance Standards
and Microbial Testing stated that the two most common concerns in the
comments received to that date were the proposed selection of
Salmonella as the indicator organism and the frequency of proposed
testing. It stated that although some commenters recommended finalizing
Salmonella testing, others recommended using E. coli instead of or in
addition to Salmonella. The issue paper stated the Agency's current
thinking on the organism to be selected, the need for daily testing at
every establishment, and the necessity of testing each species
slaughtered and each ground product produced. In the issue paper FSIS
stated, among other things, that it was ``seriously considering generic
E. coli as the process control indicator organism and the adoption of a
quantitative E. coli standard as a measure of process control with
respect to the prevention and reduction of fecal contamination in
slaughter plants.'' FSIS also stated that it was considering setting
forth pathogen-specific performance standards as a direct measure of
accountability for controlling and reducing harmful bacteria in raw
meat and poultry products and that Salmonella targets might be adopted
as performance standards and enforced by FSIS through its own
compliance monitoring. The Agency published the issue papers in the
Federal Register on October 24, 1995 (60 FR 54450).
Based on the large body of written and oral comments FSIS has
received on this issue, the Agency has decided not to use Salmonella
both as a target for pathogen reduction and as an indicator of process
control. FSIS has decided to adopt pathogen reduction performance
standards targeting Salmonella, as proposed, except that FSIS, not the
establishments, will conduct testing for the pathogen to verify
compliance. FSIS also has decided to require establishments
slaughtering livestock and poultry to conduct routine testing for
generic E. coli (instead of the proposed use of Salmonella tests) as an
ongoing, objective process control indicator for fecal contamination,
and to establish performance criteria by which results can be
evaluated.
Process Control Verification Performance Criteria
Under the FMIA and the PPIA, meat and poultry establishments
inspected by FSIS are required to maintain sanitary conditions
sufficient to prevent contamination of products with filth and to
prevent meat and poultry products from being rendered injurious to
health (21 U.S.C. 601(m) and 608 (FMIA); 21 U.S.C. 453 (g) and 456
(PPIA)). A grant of inspection by FSIS is contingent upon an
establishment meeting this responsibility. FSIS is authorized by law to
issue regulations establishing appropriate sanitation requirements.
Meat and poultry products are deemed legally adulterated, whether or
not they are shown to be contaminated, if prepared, packed, or held
under insanitary conditions whereby they may have become contaminated
with filth or may have been rendered injurious to health.
In slaughter establishments, fecal contamination of carcasses is
the primary avenue for contamination by pathogens. Pathogens may reside
in fecal material and ingesta, both within the gastrointestinal tract
and on the exterior surfaces of animals going to slaughter. Therefore,
without care being taken in handling and dressing procedures during
slaughter and processing, the edible portions of the carcass can become
contaminated with bacteria capable of causing illness in humans.
Additionally, once introduced into the establishment environment, the
organisms may be spread from carcass to carcass.
Because the microbial pathogens associated with fecal contamination
are the single most likely source of potential food safety hazard in
slaughter establishments, preventing and removing fecal contamination
and associated bacteria are vital responsibilities of slaughter
establishments. Further, because such contamination is largely
preventable, controls to address it will be a critical part of any
slaughter establishment's HACCP plan. Most slaughter establishments
already have in place procedures designed to prevent and remove visible
fecal contamination.
There is general agreement within the scientific community that
generic E. coli is the best single microbial indicator for fecal
contamination. FSIS, therefore, is requiring that establishments
slaughtering livestock or poultry begin testing for E. coli (E. coli,
biotype I, nonspecific as to species, hereinafter referred to simply as
E. coli) at the
[[Page 38838]]
frequency and following the procedures described in ``Process Control
Verification; E. coli Performance Criteria and Testing'' section,
below, 6 months after publication of the final rule. FSIS considers the
required testing to be essential for meeting current statutory
requirements for sanitation and the prevention of adulteration. This
testing also will play an integral role in the successful
implementation of HACCP in slaughter establishments. In addition, FSIS
is establishing process control performance criteria for fecal
contamination based on the frequency and levels of contamination of
carcasses with E. coli.
As explained below, FSIS is establishing performance criteria to
reflect the prevalence and levels of contamination of E. coli on
carcasses produced nationwide, as determined by FSIS baseline surveys.
The performance criteria and required testing will provide each
slaughter establishment and FSIS with an objective means of verifying
that the establishment is achieving this level of performance and
maintaining it consistently over time. Test results that show an
establishment is meeting or exceeding the criteria provide evidence
that the establishment is maintaining adequate process control for
fecal contamination.
FSIS is purposely using the term performance ``criteria'' rather
than performance ``standard'' in this context because no single set of
test results can demonstrate conclusively that adequate process control
for fecal contamination is or is not being maintained. As explained
below, if test results do not meet the applicable criterion, it raises
questions about the adequacy of the process control. FSIS intends to
consider the establishment's results and corrective actions, together
with other information and inspectional observations, in evaluating
whether a problem exists that requires regulatory action or other
measures to protect consumers and ensure compliance with the law.
Also, as discussed below, although FSIS is proceeding with the
final rule at this time, it is inviting comment on technical aspects of
the process control performance criteria and the required testing. FSIS
requests that comments on the E. coli performance criteria and testing
requirement be focused on the technical aspects of the rule, i.e., the
manner in which the criteria are articulated, the sampling frequency,
and the sampling and testing methodologies.
FSIS intends to update the criteria periodically to ensure that the
criteria adequately reflect an appropriate level of performance with
respect to prevention and removal of fecal contamination and associated
bacteria from livestock and poultry carcasses.
Pathogen Reduction Performance Standards
As proposed, FSIS is adopting pathogen reduction performance
standards using Salmonella as the target organism. The most significant
difference between the proposal and this final rule is that, as
explained above, FSIS is not relying on Salmonella to be a process
control indicator, as well as the target organism for the pathogen
reduction performance standard. Establishments will not be required by
this final rule to test for Salmonella, as had been proposed. Instead,
FSIS will obtain samples from slaughter establishments and
establishments producing raw ground product or fresh pork sausage and
test those samples for Salmonella to ensure that the pathogen reduction
performance standards are being met.
As proposed, FSIS will require that no establishment can have a
prevalence of Salmonella contamination, as a percentage of positive
samples from carcasses and percentage of positive samples from raw
ground product, greater than the baseline prevalence for each raw
product as reflected in the FSIS baseline survey for each species or
other category of raw product. These targets constitute performance
``standards'' rather than performance ``criteria'' because, following
an establishment's implementation of HACCP, FSIS will require that the
establishment meet the standard consistently over time as a condition
of maintaining inspection.
The Salmonella pathogen reduction performance standards are not,
however, lot release standards, and the detection of Salmonella in a
specific lot of raw product will not by itself result in the
condemnation of that lot. The performance standards and FSIS's
enforcement approach, as discussed below, are intended to ensure that
each establishment is consistently achieving an acceptable level of
performance with regard to controlling and reducing harmful bacteria on
raw meat and poultry products.
FSIS considers systematic reduction of pathogenic microorganisms in
raw product to be an essential responsibility of meat and poultry
establishments under the current statutes. As a condition of inspection
and to avoid the production of product that would be deemed legally
adulterated, establishments must utilize available process control
methods and technologies as necessary to achieve applicable pathogen
reduction standards.
Process Control Verification; E. coli Performance Criteria and Testing
Establishments that slaughter livestock and poultry currently have
an obligation to control the slaughter and sanitary dressing process so
that contamination with fecal material and other intestinal contents is
prevented. This means that establishments must maintain sanitary
conditions and use good manufacturing practices to avoid contamination
with visible feces and ingesta and associated bacteria. When such
visible contamination occurs, establishments are expected to detect it
and physically remove it through knife trimming or other approved
removal procedures. The present FSIS verification activity to
demonstrate that this has been accomplished is organoleptic inspection.
FSIS inspectors apply a zero tolerance performance standard for visible
feces and ingesta on dressed carcasses. As a practical matter, however,
additional measures must be taken if inspectors are to assess the
extent to which the invisible bacteria associated with feces and
ingesta may be present on the carcass.
FSIS has concluded, based on its proposal and the comments
received, that the current practice of organoleptic examination by
inspectors and the physical removal of visible contamination by
establishments needs to be supplemented with an establishment-conducted
microbial verification activity. This microbial testing is designed to
verify, for the establishment and FSIS, that the establishment has
controlled its slaughter process with respect to prevention and removal
of fecal material and ingesta and associated bacteria.
Rationale for Using E. coli Tests to Verify Process Control
E. coli testing is more useful than the originally proposed
Salmonella testing in verifying that a slaughter process is under
control. This was expressed in numerous comments on the proposal,
comments generated in FSIS public hearings, and the results of the
scientific and technical conference on the Role of Microbiological
Testing in Verifying Food Safety. The expert panel at that conference
stated:
Microbial testing is an essential element for verifying process
control of raw meat and poultry. A variety of indicators exists, but
the panel concluded that quantitative measurement of Escherichia
coli would be more effective than qualitative Salmonella testing.
When processes are under control for
[[Page 38839]]
E. coli, the potential presence of enteric pathogens will be
minimized.<SUP>1
\1\ Expert Panel's Summary Report and Recommendations,
Scientific and Technical Conference on Role of Microbiological
Testing in Verifying Food Safety, May 1-2, 1995.
---------------------------------------------------------------------------
The panel compared selection criteria for the choice of an
indicator organism and considered alternative microbial targets such as
E. coli, Enterobacteriaceae, and aerobic plate count, to be used alone
or in combination with Salmonella testing. In reaching its conclusion
that E. coli would be the most effective measure of process control for
enteric pathogens, the panel considered the ideal characteristics of
microbial indicators for the stated purpose. Important characteristics
of E. coli are:
<bullet> There is a strong association of E. coli with the
presence of enteric pathogens and, in the case of slaughtering, the
presence of fecal contamination.
<bullet> E. coli occurs at a higher frequency than Salmonella,
and quantitative E. coli testing permits more rapid and more
frequent adjustment of process control.
<bullet> E. coli has survival and growth characteristics similar
to enteric pathogens, such as E. coli O157:H7 and Salmonella.
<bullet> Analysis for E. coli poses fewer laboratory safety
issues and testing at the establishment site is more feasible than
such testing with Salmonella.
<bullet> There is wide acceptance in the international
scientific community of its use as an indicator of the potential
presence of enteric pathogens.
In the panel's view, microbial testing should be used to
demonstrate process control; they concluded that a proximate indicator
for enteric pathogens is needed for demonstrating process control with
respect to fecal contamination. The panel concluded that E. coli would
be the single most effective indicator for this purpose. The panel's
conclusion reinforces previous statements by the NAS that ``at present,
E. coli testing is the best indicator of fecal contamination among the
commonly used fecal-indicator organisms.'' <SUP>2 FSIS agrees with
these conclusions.
---------------------------------------------------------------------------
\2\ Subcommittee on Microbiological Criteria, Committee on Food
Protection, Food and Nutrition Board, National Research Council.
1985. ``An Evaluation of the Role of Microbiological Criteria for
Foods and Food Ingredients.'' National Academy Press, Washington,
D.C.
---------------------------------------------------------------------------
If future scientific research identifies another organism or group
of organisms which would prove as effective in measuring process
control for fecal contamination, FSIS would consider appropriate
revisions to the regulations.
Use of Baseline Values to Establish E. coli Performance Criteria
The presence of some microorganisms on raw meat and poultry is
unavoidable and highly variable. The goal of process control in a
slaughter establishment is to minimize initial microbial contamination
of the carcasses, remove harmful microorganisms that nonetheless may be
present, control the proliferation of any remaining microorganisms, and
prevent re-contamination. Process control criteria based on data from
FSIS's nationwide baseline surveys will aid establishments in achieving
this goal and complement the transition to HACCP.
FSIS collects data to develop and maintain a general, ongoing
microbiological profile of carcasses for selected microorganisms of
varying degrees of public health concern, and organisms or groups of
organisms of value as indicators of general hygiene or process control,
and to document changes in the profiles over time. FSIS's Nationwide
Microbiological Baseline Data Collection Programs provide for sampling
over a year's time to account for possible seasonal variations. This
was the approach taken in collecting data from carcasses for all
slaughter classes: steer/heifer, cow/bull, broilers, market hogs, and
turkey. Sampling is designed to represent the vast majority of raw meat
and poultry products produced, in most cases approximately 99% of the
product produced. These programs are nationwide in scope. Enough
samples are taken to enable the Agency to describe the annual
distribution of test results. The number of samples collected also
allows for control of sampling variation and non-sampling errors (such
as missing samples, incomplete data, and inconsistent data). By
contrast, FSIS's Nationwide Surveys provide a snapshot over a specified
period of time less than a year. They involve a large enough number of
samples to ensure a reasonable level of precision for estimates, given
the prevalence of the microorganisms included in the surveys. This was
the approach taken in developing baseline data for other raw meat and
poultry products: ground beef (at inspected establishments and at
retail), ground chicken, ground turkey, and fresh pork sausage.
For the current baselines, carcass samples were taken from fresh,
whole chilled carcasses after slaughter and dressing but before any
further processing took place. Samples were analyzed fresh, not frozen,
to gather more accurate data on numbers of microorganisms, especially
those that are more susceptible to freezing, such as Campylobacter
jejuni/coli. FSIS personnel collected the samples tested in the surveys
using standard Agency procedures for taking aseptic samples from animal
tissues and for ensuring random sample selection.<SUP>3,4
---------------------------------------------------------------------------
\3\ Food Safety and Inspection Service. 1994. Nationwide Broiler
Chickens Microbiological Baseline Data Collection Program: Broiler
Chicken Sample Collection Procedures, 2/18/94. U.S. Department of
Agriculture, Washington, D.C.
\4\ Food Safety and Inspection Service. 1993. Nationwide Beef
Microbiological Baseline Data Collection Program: Cow/Bull Sample
Collection Procedures, 8/1/93. U.S. Department of Agriculture,
Washington, D.C.
---------------------------------------------------------------------------
Reports of FSIS baseline programs and surveys are issued after
testing results have been compiled and analyzed. Reports have been
completed for cattle, broiler chickens, hogs, ground beef, ground
chicken, and ground turkey. The collection and analysis of samples for
the turkey baseline program and the fresh pork sausage survey will be
underway soon; criteria for turkeys and fresh pork sausage will be
determined upon completion of the sampling and analysis of results.
Establishment of E. coli Performance Criteria to Verify Process Control
Using data from the baseline surveys described in the preceding
section, FSIS has developed animal species-specific, minimum
performance benchmarks, or performance criteria, for E. coli on
carcasses.
As explained above, these criteria are not enforceable regulatory
standards. The E. coli performance criteria are intended to assist
slaughter establishments and FSIS in ensuring that establishments are
meeting their current statutory obligation to prevent and reduce
contamination of carcasses by fecal material, ingesta, and associated
bacteria. The criteria are flexible and are subject to amendment as
FSIS and the industry gain experience with them and accumulate more
data on establishment performance. The criteria are intended
specifically to provide an initial basis upon which slaughter
establishments and FSIS can begin to use microbial testing to evaluate
the adequacy of establishment process controls to prevent feces,
ingesta, and other animal-derived contaminants from contaminating the
tissues intended for use as food.
FSIS has designed the criteria so that establishments meeting them
are achieving results, in terms of E. coli levels, consistent with
those being achieved by a large majority of the slaughter production in
the United States, as reflected in the FSIS baseline
[[Page 38840]]
surveys for each species of livestock and poultry.
The E. coli performance criteria are expressed in terms of a
statistical procedure known as a ``3-class attributes sampling plan''
applied in a moving window. This procedure specifies cutoffs (denoted m
and M, with m<M) for quantitative E. coli levels so as to define three
classes of results: acceptable, marginal, and unacceptable. The
definitions are:
Acceptable--result <ls-thn-eq> m
Marginal--result > m and <ls-thn-eq> M
Unacceptable--result > M
Under this approach, m and M are defined in relation to the
distribution of E. coli results for each slaughter class. The Agency
has used as the starting point for establishing the cutoff for m the
80th percentile of current industry wide performance, in terms of E.
coli levels, for each slaughter class. The starting point for
establishing M is the 98th percentile of industry performance. Thus, if
the criterion for any species were set precisely at those percentiles,
a set of test results indicating performance in the 80th to 98th
percentile range, according to FSIS's Nationwide Microbiological
Baseline Data Collection Program results, would be deemed ``marginal,''
and, as discussed below, would raise a question about the adequacy of
the establishment's process control. Expressed in another way,
``marginal'' results would be within the worst 20% of overall industry
performance in terms of E. coli counts. Similarly, results worse than
the 98th percentile (M) are within the worst 2% of overall industry
performance. Any single result exceeding M is, therefore, deemed
``unacceptable.''
Table 1.--Distribution of E. coli by Slaughter Class
----------------------------------------------------------------------------------------------------------------
Percentile Steer/heifer Cow/bull Broilers Hogs
----------------------------------------------------------------------------------------------------------------
50th (median)................... Negative*......... Negative*......... 29 cfu/ml......... Negative*
80th (m)........................ Negative*......... Negative*......... 80................ 10 cfu/cm \2\
90th............................ Negative*......... 10 cfu/cm \2\..... 180............... 150
95th............................ 10 cfu/cm \2\..... 40................ 360............... 880
98th (M)........................ 80................ 300............... 1100.............. 6,800
99th............................ 290............... 2200.............. 3300.............. 33,000
----------------------------------------------------------------------------------------------------------------
* Negative by the method used in the baselines which had a minimum detectable level of 5 cfu/cm \2\ of carcass
surface area.
Table 1 shows the level at which E. coli has been found on
carcasses, by slaughter class as a percent of all such product. For
example, the data show that 80% of broilers tested at or below 80
colony forming units per milliliter (cfu/ml), while 90% tested at or
below 180 cfu/ml. More detailed descriptions of the distribution of
numbers of E. coli found per carcass species are provided in FSIS's
baseline reports.
To make the criteria as simple and easy to use as possible,
consistent with the accepted laboratory practice of diluting samples
successively by factors of 10 to obtain bacteria counts, FSIS has
elected to express the criteria in terms of powers of 10 (i.e., 10,
100, 1000, etc.). As shown in Table 2, this results in m and M being
the closest power of 10 to the actual numbers estimated for the 80th
and 98th percentiles from the baseline data.
Because the Agency's baseline survey work on turkeys is still
underway, no E. coli criterion is being established at this time for
that slaughter class.
Table 2.--m and M Values for E. coli Performance Criteria
------------------------------------------------------------------------
Slaughter class m M
------------------------------------------------------------------------
Steer/Heifer........................ (<SUP>1).................. 100
Cow/Bull............................ (<SUP>1).................. 100
Broiler............................. 100.................. 1000
Hogs................................ 10................... 10,000
------------------------------------------------------------------------
\1\ Negative.
It should be noted that ``negative,'' in this context, is defined
by the sensitivity of the method used in the Baseline Surveys, which
was 5 cfu/cm<SUP>2 of carcass surface area for cattle and hogs.
FSIS is requiring the use of an analytic method approved by the
Association of Official Analytic Chemists or any method validated by a
scientific body in collaborative trials against the three tube Most
Probable Number (MPN) method and agreeing with the 95 percent upper and
lower confidence limit of the appropriate MPN index.
FSIS has concluded that, at some point, the number of samples
testing in the marginal range raises a significant question about the
adequacy of an establishment's process control, and has defined that
point for purposes of these criteria as more than 3 results above m
within any consecutive 13 samples tested. This point was established
based on the following analysis.
There occasionally will be test results that exceed the acceptable
level, m, because of variations or aberrations in establishment
performance, sampling, etc., that do not reflect the state of overall
process control. FSIS believes that the performance criteria and
approach to evaluating test results should avoid raising a significant
process control question on the basis of chance results, but should be
sensitive enough to provide a reasonably high likelihood of detecting
performance that falls significantly short of the national baseline
levels. FSIS has decided that it is appropriate to evaluate test
results in a manner that ensures that there is an 80% probability that
establishments actually operating at the acceptable performance level
will achieve results that are deemed to satisfy the criteria. This is
the same statistical approach FSIS took in its proposed approach to
evaluating an establishment's Salmonella test results, using the moving
window approach to evaluating process control verification tests (see
pages 6798-6805 of the Pathogen Reduction/HACCP proposal).
Using this approach, it can be predicted statistically that
slaughter establishments that are operating at the acceptable
performance level reflected by m will, with an 80% probability, have
three or fewer results above m (denoted as c) within every 13 samples
tested (denoted as n). FSIS will require slaughter establishments to
record and evaluate E. coli results in a ``moving window'' of 13
consecutive results. A moving window provides a continuous picture of
establishment performance and is the preferred statistical approach for
assessing ongoing processes (as opposed to sampling specific lots of
product for contaminants). Thus, the presence of more than three
marginal results within any 13 consecutive samples, or the ``window,''
will be indicative of an operation failing to meet the criteria.
Use of a different probability level, such as a 70% or 90%
probability of getting acceptable test results if establishments are
operating at the specified level would result in different values for c
and n (namely, c=3 and
[[Page 38841]]
n=15 using the 70% probability level, and c=3 and n=10 using the 90%
probability level). Using 70% as the statistical criterion for setting
c and n would result in too many chance failures of the criteria, while
using 90% would make it too difficult to detect potential process
control problems. It is the judgment of the Agency that use of the 80%
probability level strikes a reasonable balance.
In summary, if the results of one test are above M, or if more than
3 of 13 test results are above m, a significant question is raised as
to whether the establishment is maintaining adequate process control
and will trigger further review of establishment process control. FSIS
stresses again that these E. coli criteria are guidelines, not
regulatory standards. Ideally, each establishment will develop its own
equally or more effective criteria for process control based on its own
data and/or industry-developed benchmarks. FSIS encourages
establishments, in the context of their HACCP plans, to apply their
own, establishment-specific criteria to ensure process control.
FSIS also is inviting comment on the approach it has taken to
expressing its E. coli performance criteria for verifying process
control. FSIS recognizes that there is more than one possible approach
and welcomes comments and suggestions.
Sampling Frequency for E. coli Testing
FSIS has chosen to use production volume as the basis for
determining the frequency at which establishments will conduct testing
for E. coli. In the proposed rule, FSIS proposed to require all
slaughter establishments and establishments producing ground meat and
poultry, regardless of size or volume, to conduct one test for
Salmonella each day. This was based on the premise that verifying that
a process is ``in control'' is more a function of specific
establishment characteristics than the amount of product being
produced. However, commenters suggested and FSIS recognizes that there
may be striking differences in the ways in which high and low volume
establishments operate, which can influence the ability of the
establishment to keep processes in control. High volume establishments
may receive animals for slaughter from a number of different sources
for each day's production; there may be several shifts, and production
personnel are often more transient; there may be multiple supervisors;
and there may be much greater complexity in the overall slaughter
process. In contrast, a low volume establishment will have a smaller
and possibly more stable work-force, often supervised by an owner-
operator, and may employ relatively simple procedures that are
performed consistently over time. This does not negate the need in low
volume establishments for microbial verification of a HACCP plan;
however, under these circumstances it may not be as essential for very
low volume establishments to undertake daily microbial testing, as
initially proposed. By adopting a volume-based system, the testing
frequency will, by definition, be highest in large establishments
producing the most product, while the number of tests will be minimized
in smaller establishments.
The majority of commenters who opposed daily testing stated that
such a testing requirement would place an unfair cost burden and have a
negative financial impact on small establishments, as it would require
the same expenditure for testing by establishments that slaughtered one
or two animals per day as those slaughtering several thousand daily. It
was also noted that there is a public health consequence to the
proposed approach. If a process control problem detectable by microbial
testing existed in a high volume establishment that tested only once a
day, a great deal more potentially contaminated product would be
produced and distributed before enough microbial tests were performed
to show the problem existed than would be the case in a small volume
establishment. These issues are addressed by the switch to a volume-
based testing system.
There is no single method for determining the frequency of
microbial testing within a volume-based testing system that will be
equally effective in all establishments. Testing frequencies are
ideally determined on an establishment-by-establishment basis, taking
into account a number of variables, including differences in sources of
raw materials, the type and nature of the process, and the consistency
of microbial test results over time. Nonetheless, for both public
health and process control verification reasons, FSIS considers it
necessary and reasonable to require a minimum frequency of testing
sufficient to result in completion of at least one E. coli test window
(13 samples) per day in the highest volume establishments for each
species. This will provide a daily set of results adequate to verify
process control in the highest volume establishments. Accumulation of
results over a longer period of time will be an acceptable basis for
verifying process control in lower volume establishments.
Based on these principles and conclusions, the required minimum
frequencies for E. coli testing for each slaughter species are as shown
in Table 3.
Table 3.--E. coli Testing Frequencies
------------------------------------------------------------------------
------------------------------------------------------------------------
Cattle............................ 1 test per 300 carcasses.
Swine............................. 1 test per 1,000 carcasses.
Chicken........................... 1 test per 22,000 carcasses.
Turkey............................ 1 test per 3,000 carcasses.
------------------------------------------------------------------------
The frequencies were derived by first rank-ordering all slaughter
establishments by species based on total annual production. This
ranking, which was based on data from FY 1993 and FY 1994, revealed
that establishment production volumes vary widely and that there are
appreciable differences in the concentration of business among the
industries. In cattle slaughter, 12 of 912 establishments accounted for
over 42% of production, with the smallest of these slaughtering about
one million head annually. On the small volume end, 620 establishments
slaughtered fewer than 1000 head annually and together accounted for
about one-half of one percent (0.5%) of national slaughter production.
By contrast, there are ten or fewer very low volume establishments
slaughtering chickens, and production is spread more evenly over the
240 establishments on the FSIS FY 1994 inventory of establishments. 42
of 240 slaughter establishments accounted for 40% of production.
FSIS has selected sampling frequencies so that in the subgroup of
establishments accounting for 99% of total production for each species,
the 5% of establishments with the highest production volume would each
have to conduct a minimum of 13 E. coli tests, or at least one complete
test window, each day. In addition, with these frequencies, 90% of all
cattle, 94% of all swine, 99% of all chicken, and 99% of all turkeys
will be slaughtered in establishments conducting a minimum of one E.
coli test per day.
The above frequencies notwithstanding, FSIS has concluded that all
establishments must conduct sampling at a frequency of at least once
per week to provide a minimum, adequate basis for process control
verification using E. coli testing. However, establishments with very
low volumes, annually slaughtering no more than 6,000 cattle, 20,000
swine, or a combination of such livestock not to exceed a total of
20,000 with a maximum of 6,000 cattle, or 440,000 chickens or 60,000
turkeys (or a combination of such poultry not to
[[Page 38842]]
exceed a total of 440,000, with a maximum of 60,000 turkeys), will be
required to sample once per week only until a sampling window that
verifies process control has been completed and the results indicate
that the slaughter process is under control. Establishments
slaughtering more than one species would sample the species slaughtered
in greater number. Once these criteria have been met, these
establishments will be required to complete a new sampling window that
verifies process control only once each year, in the 3-month period of
June through August, or when a change has been made in the slaughter
process or personnel.
The Agency is permitting these very low volume establishments to
conduct as few as 13 tests per year, in part because of their
relatively simple and stable production environments. The slaughtering
equipment in many cases may consist merely of a skinning bed, hoist,
bonesaw (for poultry establishments, a small scalding tank, small
defeathering device), and/or several types of knives. There are fewer
personnel and there is less turnover in general. Of course, these
establishments do change. Should there be any substantial changes in
installed equipment or personnel, a new sampling window must be
completed. These establishments must also complete a successful
sampling window annually, regardless of whether there have been any
substantial changes, in order to verify that the performance criteria
continue to be met. Many small, nonsubstantial changes, in aggregate,
may have an impact on process control. This annual testing must be
conducted during the summer months of June through August, when there
is a seasonal peak in the occurrence of foodborne diseases attributable
to the major bacteria pathogens. Published and summary reports of
Centers for Disease Control and Prevention (CDC) outbreak and sporadic
disease surveillance have documented this seasonal trend for Salmonella
spp.<SUP>5,6 and for Campylobacter jejuni/coli.<SUP>7 Although national
surveillance for E. coli O157:H7 is relatively new and data are not
available, Washington State surveillance has documented a similar
seasonal trend for that pathogen.<SUP>8 The proposed requirement of one
Salmonella sample per day would have assured testing during this
period.
---------------------------------------------------------------------------
\5\ Bean, N.H. and P.M. Griffin. 1990. Foodborne Disease
Outbreaks in the United States, 1973-1987. J. Food Protection.
53:804-817.
\6\ Centers for Disease Control and Prevention. 1995. Salmonella
Surveillance, Annual Tabulation Summary, 1993-1994. U.S. Department
of Health and Human Services, Public Health Service, Atlanta, GA.
\7\ Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K.
Wachsmuth. 1988. Campylobacter Isolates in the United States, 1982-
1986. MMWR. 37 (SS-2):1-13.
\8\ Ostroff, S.M., J.M. Kobayshi, and J.H. Lewis. 1989.
Infections with Escherichia coli O157:H7 in Washington State. JAMA
262(3):355-359.
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Therefore, the regulation specifies that when sampling and testing
is done annually, instead of continually, it be conducted within a 13-
sample window between June and August each year. This annual sampling
must occur during this period, regardless of when other sampling
windows may have occurred. Completing a successful sampling window
annually will verify that the slaughter process continues to meet the
performance criteria or will point to the need to reassess and revise
the HACCP plan.
Another reason for this approach to very low volume establishment
testing is that the total risk of exposure to enteric pathogens from
product produced at such establishments is assumed to be small and
roughly proportional to the amount of product produced. Eighty-one
percent of establishments slaughtering cattle would meet this low
volume criteria; however, these establishments together supply only
1.5% of the total national production. Further, establishments meeting
these low volume criteria constitute 86% of all swine establishments,
accounting for 1.3% of overall production. Thirteen percent of all
establishments slaughtering chicken would meet this low volume
requirement; however, these establishments together supply only 0.05%
of total national production. Similarly, 42% of all turkey
establishments are low volume establishments accounting for only 0.1%
of production.
FSIS intends that establishments operating under a validated HACCP
system use microbial testing in their process control verification
activities, and is requiring that slaughter establishments under HACCP
use E. coli testing for that purpose. As noted above, however, the
Agency acknowledges that there may be other, perhaps equally effective
alternative approaches for determining sampling frequencies for E. coli
testing for process control verification in slaughter establishments
with a carefully designed HACCP system. The Agency is aware that
comparable models have been developed in the context of quality
assurance programs. These models, however, are part of programs that,
like HACCP, involve more than mere statistical sampling, and usually
are much more oriented to specific establishment/process/product
combinations. Such models cannot easily be transferred to a nationwide
collection of producers of a product, each with unique characteristics.
The frequency rule established in this regulation recognizes the
relevance of establishment characteristics in the area of verification,
as in other facets of the HACCP plan, and therefore allows slaughter
establishments to alter frequencies as appropriate for their
circumstances when they institute HACCP. That is, slaughter
establishments under HACCP may use a sampling frequency other than that
provided for in the regulation, if the alternative sampling frequency
is an integral part of the establishment's HACCP verification
procedures and if FSIS does not determine, and notify the establishment
in writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
Establishments electing to institute HACCP prior to the dates required
may use an alternative sampling frequency upon presentation to FSIS of
data demonstrating the adequacy of that sampling frequency for
verification of process controls to prevent fecal contamination.
Establishments currently using an alternative E. coli sampling
frequency for process control purposes, but not yet under a HACCP plan,
will have to test at the frequencies specified in the regulation unless
they have been granted an exemption by FSIS. However, after
consideration of comments received on this rule that may result in
protocol changes affecting all establishments, and publication of a
Federal Register document addressing the comments, FSIS will consider
requests for such exemptions on a case-by-case basis, upon the timely
submission to FSIS of data demonstrating the adequacy of the
alternative frequency for verification of process controls to prevent
fecal contamination.
Sampling and Analytical Methodology
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control. Such
consistency also will facilitate FSIS verification activities. As
discussed below, the performance criteria are applicable to each type
of carcass, industry-wide, based on FSIS's national baseline survey
data. Because each establishment's performance is measured against the
[[Page 38843]]
performance of all surveyed establishments producing the same kind of
product, it is essential that all like establishments adhere to the
same basic sampling and analysis requirements.
Each establishment is responsible for having written sampling
procedures that are to be followed by a designated employee or agent.
Samples are to be taken randomly at the required frequency. If an
establishment runs more than one line, the lines from which samples are
to be taken also are to be selected randomly. Samples from livestock
carcasses are to be collected by a nondestructive method that requires
a commercially available sampling sponge to be rubbed on the carcass
surface after the carcass has been chilled in the cooler for 12 hours
or more after slaughter. Establishments are required to take samples
from three sites on each carcass. These three sites are the same ones
that were used by FSIS when conducting the baseline studies for cattle
and swine. On cattle carcasses, establishments will take samples from
the flank, brisket, and rump areas; on swine carcasses, samples will be
taken from the ham, ``belly,'' and jowl areas. The sponge is to be
placed afterwards in an amount of buffer to transfer any E. coli to a
solution, which then is analyzed for E. coli. Samples from poultry
carcasses will be collected by taking whole birds from the end of the
chilling process, after the drip line, and rinsing them in an amount of
buffer appropriate for the type of bird being tested.
The sponge sampling technique to be used on swine and cattle
carcasses has been subject to many studies. A sponge technique has been
reported by Dorsa et al.<SUP>9 and others, including Gill et
al.<SUP>10, as an acceptable means of in-plant sampling to detect fecal
contamination.
---------------------------------------------------------------------------
\9\ Dorsa, W.J., C.N. Cutter, G.R. Siragusa. 1996. Evaluation of
Six Sampling Methods for Recovery of Bacteria from Beef Carcass
Surfaces. Letters in Applied Microbial. 22:39-41.
\10\ Gill, C.O. J.C. McGinnis, M. Badoni. 1996. Assessment of
the Hygienic Characteristics of a Beef Carcass Dressing Process. J.
Food Protection 59(2):136-140.
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The excision method for sample collection would not be acceptable
for routine sampling to verify process control because this defaces the
carcass, and some establishments would be required to sample 13
carcasses per day. Instead, for both cattle and swine carcasses, the
sponge method requires that 100 cm<SUP>2 at each of the three sites be
sampled by swabbing, for a total area of 300 cm<SUP>2 compared to the
60 cm<SUP>2 area of excised tissue analyzed in the baseline studies for
cattle and swine. The results would still be reported on a square
centimeter basis. The larger sampling area for the swabbing method is
expected to provide results comparable to the excision technique.
The exact correlation between the sponging technique and the
excision technique used during the baseline surveys is being assessed
by ARS. Currently available results indicate a high degree of
correlation between the two. These studies and any other new microbial
sampling data will be made available to the public. This sponging
technique will also be used in the FSIS Salmonella program. FSIS is
continuing to improve the sponging technique and welcomes comments.
FSIS considered providing that samples be taken from only one site
on livestock carcasses: from the brisket on cattle and the belly area
on swine. Sampling from one site has advantages. It would be less labor
intensive. Further, sampling from one site might pose fewer worker
safety problems than sampling from three sites because, for the latter
option, a ladder generally is needed to reach the rumps of the
suspended carcasses. Nonetheless, FSIS has determined that slaughter
establishments must take samples from the three sites from which
samples were drawn during the baseline studies or programs in the
absence of data demonstrating that one-site sampling also will provide
results comparable to the baseline survey data. The Agency invites
comments on its requirement that establishments collect samples from
the specified three sites on swine and cattle carcasses and the
adequacy of alternative sampling approaches.
Samples may be analyzed in either the establishment's own
laboratory or a commercial laboratory. Samples must be analyzed by a
quantitative method of analysis for E. coli. The method must be
approved by the Association of Official Analytic Chemists or validated
by a scientific body in collaborative trials against the three tube
most probable number (MPN) method and agreeing with the 95 percent
upper and lower confidence limit of the appropriate MPN index.
FSIS has developed and is publishing as an appendix to the document
guidelines that provide additional, detailed information on how best to
sample, test, record, and interpret results for E. coli under this
regulation. FSIS invites comment on these guidelines.
Recordkeeping
Results of each test must be recorded, in terms of colony forming
units per milliliter (cfu/ml) for poultry carcasses or per square
centimeter (cfu/cm<SUP>2) for livestock carcasses, on a process control
chart or table that permits evaluation of the test results in relation
to preceding tests in accordance with the applicable criteria. These
records must be maintained at the establishment for 12 months and must
be made available to Inspection Program employees on request.
Inspectors will monitor results over time, to verify effective and
consistent process control.
Use of E. Coli Test Results by Establishments
As discussed in preceding sections, establishments slaughtering
livestock or poultry are required to use E. coli testing and evaluation
of the results to verify the adequacy of their process controls for
fecal contamination. Any test result in the marginal range (above m)
indicates to the establishment that there is a potential problem in its
processing control that may require attention. If the number of test
results above m exceeds the specific number allowed, c (3, for all
species), in the specific number of consecutive tests in the moving
window, n (13 for all species), the establishment has failed to meet
the performance criteria, and a significant question has been raised
about the adequacy of the establishment's process controls for fecal
contamination. Review of the process by the establishment and necessary
corrective actions are strongly suggested.
Results above the upper value M are unacceptable and should trigger
immediate establishment review of slaughter process controls to
discover the cause of the failure and to prevent recurrence, and, if a
product has been affected, to consider the status and proper
disposition of the product as the circumstances dictate.
Use of E. coli Test Results by FSIS
FSIS personnel, like establishment personnel, will use the E. coli
test results to help assess how well the establishment is controlling
its slaughter and dressing processes. FSIS will compare establishment
test results to the applicable E. coli performance criterion. A single
failure to meet the criterion does not by itself demonstrate a lack of
process control or product adulteration, but it will trigger greater
inspection activity to establish that all applicable sanitation and
process control requirements are being met and product is not being
adulterated. Inspectors may make additional visual inspections of
products and/or equipment and facilities, collect samples for FSIS
laboratory analysis, and retain or condemn product, as appropriate. In
addition, Sanitation
[[Page 38844]]
SOP's and HACCP records will be reviewed, as appropriate. Failure to
meet the criterion may also result in the establishment being selected
for intensified Agency testing for Salmonella under the pathogen
reduction performance standard sampling program; and, if the
establishment produced ground beef, its product could be targeted in
the E. coli. O157:H7 ground beef testing program.
The E. coli test results will be used by FSIS, along with all other
relevant data and observations, including past establishment
performance, to determine whether a slaughter establishment is meeting
its process control responsibilities. Repeated failures to meet the
criterion would lend support to a finding that the establishment's
process controls are inadequate. Failure to maintain adequate process
control will result in suspension and withdrawal of inspection, as
appropriate. Such actions will be made in accordance with rules of
practice that will be adopted for those proceedings.
After a slaughter establishment implements HACCP, the E. coli
testing program will continue as a HACCP verification activity.
Isolated or occasional failures to meet the E. coli performance
criterion may indicate that establishment personnel need to take
corrective actions spelled out in their HACCP plan. Repeated failures
to meet the criterion will result in FSIS focusing its verification
oversight on relevant CCP's, which could lead to the need for HACCP
plan reassessment by the establishment, as well as other inspection and
compliance related activities that may be appropriate, as discussed
above.
Implementation Timetable
Six months from this publication date, establishments that
slaughter livestock or poultry will be required to begin sampling and
testing for E. coli at the volume-based rates described above. From
that time, those establishments that do not test or fail to keep
records of results as prescribed by the regulation will be subject to
withdrawal of inspection in accord with the procedures set forth in 9
CFR 335.13 or 381.234. After another six months, i.e., 12 months after
publication of this final rule, after establishments have had an
opportunity to gain experience in conducting this testing, recording
the results, and using the data to verify and improve process control,
FSIS personnel will incorporate the review of establishment E. coli
test results into its inspection routine.
In considering the timeframe for implementing the E. coli testing
requirement, FSIS has taken into account the practicality of initiating
such testing in a large number of establishments, the potential utility
of the resulting data to establishments as they prepare for HACCP
implementation, and the added consumer protection of having
establishments, particularly those scheduled to implement HACCP towards
the end of the implementation timetable, initiating testing and
evaluating results against the process control performance criteria.
FSIS is aware that many establishments, especially large ones, already
use microbial testing as a means of verifying their process control
systems; many may already be testing for generic E. coli. Some of those
establishments may already have HACCP plans in place as well.
Establishments performing microbiological testing and already working
under HACCP plans have found that such testing is an important element
in conducting a hazard analysis, validating HACCP plans, and verifying
the ongoing effectiveness of HACCP systems.
For establishments that are not already performing microbiological
testing and not operating under HACCP plans, the data will be valuable
in revealing how well or poorly their slaughter process is performing
in microbiological terms, when compared against the microbial
characteristics of a large portion of national production, and will
provide an indication of whether immediate actions are required to
prevent product adulteration and protect food safety. In addition, such
data, when accumulated over a period of time, will contribute to the
conduct of hazard analyses and selection of process control measures.
Collection of these data will provide benchmarks for each establishment
as it begins to understand the food safety implications of its
processes and how to improve them.
In the meantime, FSIS personnel, using the performance criteria as
benchmarks for overall industry performance in terms of the number of
E. coli organisms found on carcasses at a specific point in the
slaughter process, will be able to review establishment data and other
evidence to determine if each establishment is achieving an acceptable
level of performance.
Request for Comments
The Agency is soliciting additional comment and information on a
number of technical issues concerning the protocols for E. coli
testing, and on that basis will consider adjusting those protocols
prior to the effective date. In particular, two concerns have been
raised on the issue of the rule's statistical framework: 1) the
representativeness of the proposed sample collection, and 2) the levels
and distribution of E. coli on carcasses and the ways in which these
levels affect the utility of the proposed testing protocol.
Because poultry slaughter establishments must collect samples with
a whole bird rinse, the representativeness of the sampling site is not
an issue; the entire bird is being sampled. FSIS used this technique
when collecting baseline data and therefore, establishment data should
be comparable to baseline survey data. Further, greater than 99 percent
of broiler carcasses in the national baseline survey had detectable E.
coli. Generic E. coli testing data therefore clearly will be useful to
poultry slaughter establishments as they initiate HACCP and begin to
verify the associated process control procedures. E. coli testing
procedures for poultry required by this rule comport well with the
available scientific data and discussions held as part of the public
comment process.
More difficult issues arose in developing E. coli sampling
procedures for cattle and swine carcasses. Part of the concern, as
discussed, stems from the fact that a whole carcass rinse is impossible
with a large carcass, and thus it is necessary to select specific
sampling sites. Selections of sites, in turn, may influence results,
particularly if generic E. coli is not randomly distributed on the
carcass. Site selection may also influence the usefulness of resultant
data. For example, the appropriate response to an elevated generic E.
coli level on the rump of a beef carcass may be different from the
appropriate response to an elevated generic E. coli level at the site
of the midline incision. The Agency wants comments on the relative
merits of a one-site versus three-site sampling approach.
Another concern revolves around the correlation between non-
destructive and destructive sampling. The baseline surveys used
destructive sampling, that is, culturing of tissue excised from the
carcass. FSIS agrees with commenters that reasonable results can be
obtained with a non-destructive swabbing technique for sampling.
Preliminary data indicate that results obtained with a destructive and
non-destructive sampling are comparable, although studies continue.
Another concern arises from the statistical basis for E. coli
testing. In
[[Page 38845]]
particular, the levels of generic E. coli on cattle carcasses in the
national baseline survey were low, with the majority of carcasses
having no detectable E. coli. This could raise questions about the
utility of the E. coli test results in evaluating process controls in
establishments slaughtering cattle.
The principal utility of process control testing stems from the
availability to a establishment of results over time from that
establishment. The tracking of trends and identification of anomalous
results permits isolation and correction of problem areas that might
otherwise go unnoticed. FSIS has concluded that testing for generic E.
coli is the appropriate and necessary means by which meat and poultry
slaughter establishments must evaluate and verify the adequacy of their
process controls. FSIS considers systematic measures to prevent and
remove fecal contamination and associated bacteria, coupled with
microbial testing to verify effectiveness, to be the state of the art
in slaughter establishment sanitation. Microbial testing for bacteria
that are good indicators of fecal contamination and the regular
availability of test results will help to focus establishments on the
effectiveness of their measures for preventing and removing fecal
contamination and will provide information establishments can use in
maintaining adequate process control. FSIS reached this conclusion upon
its review of written comments received on the proposal and comments
made at the scientific conferences and public meetings, as well as
available scientific data, and has retabulated and reassessed its
baseline data as it applies to the E. coli testing in the rule.
In the first reassessment, it was determined that the lower levels
and more frequent negative test results of E. coli found on livestock,
particularly steers and heifers, as compared to poultry in the baseline
survey data does not undercut the utility of the E. coli criteria which
are also based on the baseline survey data. FSIS tested the performance
criteria in this rule by applying it to plant-specific test results
obtained during the baseline surveys. FSIS looked at data from
establishments for which at least 20 test results were available, and
listed the results by collection date much as would be done by the
establishments under the rule. The Agency found that about half of the
establishments in each of the livestock slaughter categories fully met
the criteria, which suggests that those establishments have good
process controls for prevention of fecal contamination. The Agency also
found that many establishments failed to meet the applicable E. coli
criterion (any result above M, or more than 3 results above m out of
the most recent 13 test results): 2 out of 30 steer/heifer
establishments, 10 out of 34 cow/bull establishments, and 11 out of 31
market hog establishments failed to meet the criterion at least 20% of
the time, suggesting that a significant number of livestock slaughter
establishments should review and make adjustments to their process
controls.
The Agency also made an assessment of whether the baselines show
true differences in E. coli results among establishments that slaughter
the same categories of livestock. The Agency did a statistical analysis
of a hypothesis: percents positive are equal among establishments
slaughtering the same category of livestock. The analysis involved
comparing E. coli test results of pairs of establishments. This
comparison showed wide ranges in the percents positive between
establishments albeit smaller differences among steer/heifer
establishments. The percents positive ranged between 0.0 to 27.1 for
steer/heifer establishments, 0.0 to 45.2 for cow/bull establishments,
and 2.2 to 97.1 for market hog establishments. The hypothesis,
therefore, was rejected because the data showed significant differences
in the prevalence of E. coli on carcasses of animals found in
establishments slaughtering the same categories of livestock.
The retabulated data developed for these two analyses are available
for viewing in the FSIS Docket Room (See ADDRESSES) as part of the
administrative record of this rulemaking.
FSIS invites comments on the statistical frameworks it has used for
E. coli testing and performance criteria. The Agency is open to the
possibility that it might further improve its testing protocols prior
to the implementation date, and is seeking additional relevant
scientific and economic data. In particular, in light of the concerns
noted above, FSIS is seeking additional data relating to the
distribution of generic E. coli on cattle and swine carcasses,
differences in E. coli levels within and between establishments, and
the appropriateness of various data sets for establishing the proposed
80th and 98th percentile national criteria for generic E. coli levels
on cattle and swine carcasses.
FSIS also requests comments and information addressing the
following questions:
Are there alternative, equally or more effective risk based
microbial sampling protocols that could be used for process control
verification by establishments that slaughter cattle or swine?
Are there more appropriate anatomical sites for microbial
testing than those adopted?
Are there alternative sampling frequencies that would elicit
results more indicative of process control performance?
How could the proposed testing protocol be revised to better
account for differing establishment characteristics and how can FSIS
minimize the cost to establishments of E. coli testing without
sacrificing testing effectiveness?
Are there worker safety concerns regarding sampling from
difficult to reach carcass sites and, if so, how might they be
mitigated?
Given that testing is based on production volume, are there
effective approaches other than requiring very small establishments
to conduct a minimal amount of testing during certain months of the
year?
FSIS is aware that some individuals, companies, and trade groups
have conducted research and have data on the various carcass sampling
sites and associated levels of bacteria at these sites (carcass
mapping). FSIS welcomes any information concerning E. coli and other
microorganisms at various sites on carcasses.
FSIS has opted to establish performance criteria based on the
levels and distribution of E. coli for the various slaughter classes.
Some individuals and companies may have established their own criteria
for process control verification. FSIS welcomes information on the
rationales, sampling plans and protocols on which any such criteria are
based, as well as data (or data summaries) collected under such
protocols.
FSIS welcomes any new or unpublished research results or
information that exists concerning the relationship between the
presence of generic E. coli and the presence of other pathogenic
microorganisms on cattle and swine carcasses.
FSIS specifically invites establishments currently conducting
generic E. coli testing for process control verification to submit data
regarding their costs, including labor and training costs, as well as
testing costs per unit. FSIS will use this data to assess the merits of
alternative testing protocols.
FSIS invites comments on how, and the extent to which, it should
summarize and make available to the industry and public E. coli testing
data made available to it under these regulations. Reports on the
collective experiences of establishments with various characteristics
could be useful to the industry, the Agency, and the public at large.
In light of these issues, in particular those reflecting continuing
concerns
[[Page 38846]]
about the applicability of the national criteria to all affected
establishments, the frequency and other parts of the testing protocols,
and the statistical utility of the establishment's test results as a
measure of process control, FSIS plans to conduct two public
conferences. The first conference is planned to be held approximately
45 days into the 60 day comment period following publication of this
rule. This public conference will be led by a panel of scientists from
FSIS and other government agencies who will listen to testimony and
review comments received on these technical issues and share their
observations and opinions. FSIS will consider their input along with
all comments received as the basis for any necessary technical
amendments, which will be completed at least 30 days before the
implementation date. The second public conference is tentatively
planned for approximately 9 months following publication of this final
rule. This conference would be an opportunity for the industry and
others to discuss with FSIS new information based on about 3 months of
testing experience that may bear on these same issues and might allow
for further adjustments of protocols before FSIS inspectors are tasked,
about three months later, with comparing test results to the national
criteria as part of their inspection routine. FSIS will publish
further, more detailed notice of these conferences in future issues of
the Federal Register.
Pathogen Reduction Performance Standards
The pathogen reduction performance standards for Salmonella FSIS is
establishing in this final rule complement the process control
performance criteria for fecal contamination and E. coli testing.
The likelihood of product contamination by Salmonella is affected
by factors in addition to the incidence or degree of fecal
contamination, including the condition of incoming animals and cross
contamination among carcasses during the slaughter process and further
processing. Under HACCP, establishments will be expected to establish
controls wherever practicable to address and reduce the risk of
contamination with harmful bacteria. The pathogen reduction performance
standards FSIS is establishing for Salmonella are an important step
toward enabling FSIS and the establishment to verify the aggregate
effectiveness of an establishment's HACCP controls in reducing harmful
bacteria.
Rationale for Selecting Salmonella
In the future, FSIS may develop pathogen reduction performance
standards targeting a number of pathogens. Initially, however, FSIS has
developed pathogen reduction performance standards only for one--
Salmonella. Salmonella is an enteric pathogen, which as a group cause
most preventable illnesses associated with meat and poultry.
FSIS has selected Salmonella because: (1) it is the most common
bacterial cause of foodborne illness; (2) FSIS baseline data show that
Salmonella colonizes a variety of mammals and birds, and occurs at
frequencies which permit changes to be detected and monitored; (3)
current methodologies can recover Salmonella from a variety of meat and
poultry products; and (4) intervention strategies aimed at reducing
fecal contamination and other sources of Salmonella on raw product
should be effective against other pathogens.
Basis for Performance Standards and Plans for Future Adjustments
The pathogen reduction performance standards for Salmonella are
based on the current prevalence of Salmonella, as determined from
FSIS's baseline surveys. Current prevalence percentages based on the
data from these surveys are listed in Table 4 and in the regulations
(new Secs. 310.25(c)(3)(ii) and 381.94(c)(3)(ii)) under the column
headed ``Performance Standard.'' This is the performance standard that
establishments must achieve, not on a lot-by-lot basis, but
consistently over a period of time through appropriate and well-
executed process control.
This is the same approach to setting the ``interim targets for
pathogen reduction'' that FSIS proposed in its Pathogen Reduction/HACCP
proposal. As explained in the preamble to that proposal, basing the
performance standard on the national baseline prevalence means that
some establishments are already meeting or exceeding the standard,
while other establishments are not. FSIS believes that it is feasible
for all establishments to meet or exceed the current baseline
prevalence of contamination with Salmonella, through careful process
control to prevent contamination and incorporation of readily available
food safety technologies and procedures to remove contamination. The
feasibility of achieving this standard is demonstrated by the fact that
many establishments are already doing so.
The Agency believes that most establishments maintaining sanitary
conditions under their Sanitation SOP's and operating under validated
HACCP plans, as provided for elsewhere in this regulation, will be able
to meet the pathogen reduction performance standards without major new
costs. For example, HACCP plans for slaughter establishments are
expected to address the condition of incoming animals, and may provide
for more systematic control of relevant processes or interventions,
such as the cleaning of animals or carcasses before evisceration. HACCP
systems should, therefore, result in many establishments improving the
microbial profile of their finished raw products.
Slaughter establishments concerned that they might not meet the
pathogen reduction performance standard have available a wide range of
technologies shown to reduce the levels of pathogens that may be on the
surface of carcasses. As discussed in some detail in the proposed rule,
antimicrobial treatments normally include washes or sprays that use
either hot water or a solution of water and a substance approved by
FSIS for that use. Such substances include acids (lactic, acetic, and
citric), trisodium phosphate (TSP), and chlorine. In addition, FSIS has
recently established that spray-vacuum devices that apply pressurized
steam or hot water to beef carcasses and immediately vacuum it up also
are effective in reducing bacteria on carcasses.
Establishments producing raw ground product from raw meat or
poultry supplied by other establishments cannot use technologies for
reducing pathogens that are designed for use on the surfaces of whole
carcasses at the time of slaughter. Such establishments may require
more control over incoming raw product, including contractual
specifications to ensure that they begin their process with product
that meets the standard, as well as careful adherence to their
Sanitation SOP's and HACCP plan.
By basing its Salmonella performance standards on the current
national baseline prevalence for each major species and product class,
FSIS is applying a uniform policy principle: all establishments must
achieve at least the current baseline level of performance with respect
to Salmonella for the product classes they produce. This policy is
based on the public health judgment that reducing the percentage of
carcasses with Salmonella will reduce the risk of foodborne illness,
and on the regulatory policy judgment that establishing for the first
time a clear standard for Salmonella, in conjunction with the
implementation of HACCP, will lead to significant reductions in
[[Page 38847]]
contamination rates. This policy is not based on a quantitative
assessment of the risk posed by any particular incidence of Salmonella
contamination or the determination of a ``safe'' incidence or level.
There is not currently a scientific basis for making such assessments
or determinations.
FSIS recognizes that this approach results in a range of
performance standards among the various product classes (see Table 4).
For example, the current Salmonella prevalence for broilers is 20
percent, while the current prevalence for steers and heifers is 1
percent. This range reflects the current level of performance for each
class of product, as reflected in the FSIS baseline surveys.
FSIS intends to revise its Salmonella performance standards
periodically as new baseline prevalence data become available and in
furtherance of the Agency's goal of reducing the risk of foodborne
illness. FSIS will periodically repeat its baseline studies to assess
the overall progress of the pathogen reduction effort. Also, as
indicated below in the discussion of the FSIS testing strategy, FSIS
will be conducting extensive Salmonella testing to ensure compliance
with the pathogen reduction performance standards. If the data from
this testing or future baseline surveys justify revision of the
performance standards, FSIS will promptly publish such revisions for
public comment in the Federal Register. FSIS anticipates revision of
these performance standards downward as justified by progress in
pathogen reduction and demonstrated reductions in the national baseline
prevalence of Salmonella. In making such adjustments, FSIS will take
into account the state of scientific knowledge, available technology,
feasibility, and public health benefits to be achieved. FSIS will also
consider the current level of industry performance with respect to
Salmonella prevalence in particular classes of livestock and poultry.
It is anticipated that such adjustments would more likely occur in
classes with the highest prevalence. FSIS originally proposed to call
these performance ``interim'' standards or targets. The final rule
removes that language.
Approximately 15 months after the publication of this final rule,
FSIS will convene a public conference to review available Salmonella
data and discuss whether they warrant refining the Salmonella
performance standards. Prior to the conference, FSIS will make
available the data resulting from the pre- implementation phase of the
FSIS Salmonella testing program. FSIS also will take advantage of this
conference to receive public input on the E. coli testing program. FSIS
will extend an invitation to all interested parties.
Additionally, FSIS intends to work closely with other Federal
agencies and the scientific community to improve the scientific basis
for establishing food safety performance standards for microbial
pathogens. In particular, the Executive Office of the President, Office
of Science and Technology Policy, will oversee a task force to
determine what research and data collection are needed to develop a
workable approach to quantitative risk assessment for foodborne
pathogens and determine the most cost-effective way of conducting the
necessary research. FSIS and other USDA agencies will participate in
this government-wide task force.
Determining Compliance With the Standard
The pathogen reduction performance standards specify for each
species and category of raw product a maximum number of positive test
results (c) permitted to be found in a specified number of samples (n)
for each class of raw product before the establishment will be deemed
to be exceeding the performance standard. The standards were determined
by first calculating for each category of product tested in the FSIS
national baseline programs and surveys the percentage of Salmonella
positives nationwide. This is, in effect, the performance standard that
must be achieved consistently by each establishment over time. Then the
number of samples to test (n) and the number of positives to allow from
among those samples (c) were calculated to provide approximately an 80%
probability of passing when the establishment is operating at the
national baseline prevalence of Salmonella positive results, i.e., just
within the performance standard. As discussed in the preamble to the
Pathogen Reduction/HACCP proposal and above with respect to E. coli
testing, the statistical criteria for evaluating Salmonella test
results balance the need to prevent establishments from failing to meet
the standard, based on chance results, and the need to ensure both that
violations are readily detected and that establishments have an
incentive to improve their performance beyond what is minimally
required by the standard. The resulting values for the pathogen
reduction performance standards are shown in Table 4.
Table 4.--Pathogen Reduction Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance
standard Maximum number
(percent Number of of positives
Class of product positive for samples to achieve
Salmonella) tested (n) standard (c)
(%)
----------------------------------------------------------------------------------------------------------------
Steers/Heifers.................................................. 1.0 82 1
Cows/Bulls...................................................... 2.7 58 2
Ground Beef..................................................... 7.5 53 5
Fresh Pork Sausage.............................................. *NA *NA *NA
Broilers........................................................ 20.0 51 12
Hogs............................................................ 8.7 55 6
Ground Turkey................................................... 49.9 53 29
Ground Chicken.................................................. 44.6 53 26
Turkeys......................................................... *NA *NA *NA
----------------------------------------------------------------------------------------------------------------
* Not available at this time.
FSIS has concluded that, for purposes of this rulemaking, it should
rely only on FSIS baseline data for determinations of the prevalence of
bacteria on which it is establishing standards. The proposal discussed
the possibility of relying on other data sources, such as industry
surveys or other reports in the scientific literature. No such data
were
[[Page 38848]]
submitted to FSIS in response to the proposal, and FSIS has concluded
that those alternative data sources are not likely to provide the
nationwide, objective data that are needed for the Agency's regulatory
purpose of establishing performance standards. FSIS will consider
modifications of the scope and approach to these surveys and additional
data sources, as the needs of public health dictate, but will continue
to rely only on data that are gathered with appropriate scientific
rigor.
FSIS has completed its baseline survey work and has issued reports
on its findings for Steers/Heifers, Cows/Bulls, Broiler Chickens,
Market Hogs, Ground Beef, Ground Chicken, and Ground Turkey. Copies of
these reports are available for inspection in the FSIS Docket Room (see
ADDRESSES).
FSIS is currently conducting the fresh pork sausage survey and will
begin the Baseline Program for turkeys soon. Therefore, performance
standards for fresh pork sausage and turkeys cannot be established at
this time. The performance standards for these two classes of products
will be published for public comment once FSIS's reports on the data
are available.
FSIS will determine an establishment's compliance with the
applicable pathogen reduction performance standard by taking the
indicated number of samples, generally at the rate of one or more per
day, testing each sample for Salmonella, and determining whether the
number of positive results is above the maximum permitted for that
product in the regulation.
FSIS has established performance standards for Salmonella on
carcasses and on raw products derived from meat and poultry. Because
Salmonella is more likely to be present on raw, ground, or comminuted
products than on the carcasses from which they are derived, raw,
ground, or comminuted product ordinarily will be the focus of FSIS
compliance testing in those establishments that both slaughter and
produce raw ground product.
The pathogen reduction performance standard applies to
establishments, not to individual products. As discussed,
microbiological testing of raw products for purposes of routinely
separating adulterated from unadulterated products is impractical at
this time. The pathogen reduction standard for Salmonella requires
testing of products not for purposes of determining product disposition
(although in some circumstances it may contribute to additional
inspection or compliance activities that do), but rather as a measure
of the effectiveness of the process in limiting contamination with this
particular pathogen. If an establishment fails to meet the standard, it
must institute corrective actions to lower the incidence of Salmonella
on all such product it produces as measured by subsequent testing, or,
ultimately, it must cease producing that product. The FSIS enforcement
strategy is further discussed below.
FSIS Testing Strategy
FSIS's Salmonella testing program will be implemented in two
phases, a pre-implementation phase and a compliance phase. The pre-
implementation phase will begin approximately three months after
publication of the final rule and initially will consist of an
establishment-by-establishment survey of the slaughter establishments
represented in the National Microbiological Baseline Data Collection
Programs. These establishments account for approximately 99 percent of
the total production volume for each of the major species slaughtered
nationwide. The testing in each slaughter establishment will be
conducted in a manner designed to provide a reliable picture of the
establishment's performance throughout a 12-month period, in relation
to the pathogen performance standard applicable to the species being
slaughtered. It is anticipated that initially FSIS will take
approximately 250 samples per establishment over a one-year period,
with testing to be completed before the implementation date for the
standard in each establishment.
FSIS will also conduct pre-implementation testing in ground product
establishments and in establishments that account for the remaining one
percent of production and that were not included in the FSIS baseline
surveys. This testing will be conducted in a manner and at a level that
takes into account the size and nature of the establishments involved.
FSIS will provide more detail on this testing soon in a separate
notice.
This pre-implementation testing will inform both the establishments
and FSIS, prior to the actual enforcement of the performance standards,
whether each establishment is already meeting the standard, is close to
meeting the standard, or requires substantial improvement to meet the
standard. As with all FSIS testing done to check compliance with the
pathogen reduction standards, the testing results will be provided to
the establishment by FSIS. These testing results will assist
establishments in designing and validating their HACCP plans as needed
to ensure that products meet pathogen reduction performance standards.
This information also will assist FSIS to more effectively target its
compliance testing after the standards go into effect, as discussed
below. This FSIS-generated data on the prevalence of Salmonella on
inspected products will be available to the public.
Upon the implementation of HACCP, and upon publication of Federal
Register documents concerning the pathogen reduction performance
standards for which baseline survey reports have not yet been
published, FSIS will initiate phase 2, the compliance phase, of its
Salmonella testing program in affected establishments. As an integral
part of its overall responsibility for food safety, FSIS will conduct
an ongoing testing program to determine compliance with the Salmonella
performance standard for all classes of livestock and poultry. In
addition, FSIS will conduct a program of targeted testing where
warranted. The frequency and intensity of this testing will be
determined based on past establishment performance, the establishment's
own generic E. coli test results, FSIS inspectional observations,
reports of illness associated with product produced at an
establishment, the results of Salmonella testing during the pre-
implementation phase, previous failures to meet the performance
standards, and other factors.
The costs to FSIS of this testing for Salmonella, estimated to be
approximately 2 million dollars annually, are addressed in the Final
Regulatory Impact Analysis of this rule.
FSIS Testing Methods
Details of the sample collection and testing procedures the Agency
will be using are in Appendix E, ``FSIS Sample Collection Guidelines
and Procedure for Isolation and Identification of Salmonella from Raw
Meat and Poultry Products.''
FSIS Enforcement Strategy
The objective of FSIS's enforcement policy with respect to
microbial testing is to achieve compliance with the regulations. With
respect to Salmonella, the Agency's goal is to achieve pathogen
reduction by ensuring that all slaughter and ground product
establishments meet the performance standards established by FSIS. FSIS
intends to achieve this goal through an enforcement strategy based on
the two-part testing program mentioned above: the ongoing testing,
which will include all establishments at some fixed interval,
irrespective of performance;
[[Page 38849]]
and targeted testing focusing on establishments unable to meet the
Salmonella performance standard when tested by FSIS or for the other
reasons discussed above.
The Salmonella enforcement strategy will embody an objective,
uniform systems approach to ensure that it is administered and applied
in a fair, equitable, and common-sense manner. The Agency will
carefully monitor and adjust its enforcement program on an ongoing
basis to ensure that its enforcement activities reflect these
principles while ensuring food safety.
If ongoing or targeted testing in an establishment indicates the
performance standard is not being met, FSIS will decide whether to
conduct follow-up testing on the basis of several factors. If an
establishment with Salmonella test results marginally above the limit
takes corrective action, FSIS could judge, based on the establishment's
actions and other factors relevant to ensuring food safety, that
immediate follow-up testing is not necessary. If, however, that
establishment were to take inadequate corrective action after failing
to meet the Salmonella performance standard, or if it simply ignored
that failure, FSIS will conduct a second series of tests. FSIS will
invariably conduct further testing at all establishments whose test
results significantly exceed the standard.
If an establishment fails the second, targeted series of FSIS-
conducted tests, the establishment will be required to reassess its
HACCP plan for the tested product, modifying the plan as necessary to
achieve the Salmonella performance standard. If the establishment fails
to modify its HACCP plan as necessary, or if it fails the third series
of targeted tests, FSIS will suspend inspection services. The
suspension will remain in effect until the establishment demonstrates
its ability to meet the performance standard.
The probability of an establishment failing the Agency's pathogen
reduction standard three consecutive times is less than 1% when the
establishment prevalence is at the limit of the standard.
Implementation Timetable for Pathogen Reduction Performance Standards
Slaughter establishments and establishments producing raw, ground,
and comminuted product subject to these pathogen reduction performance
standards must meet the Salmonella standard at the time the
establishment is required to implement HACCP. As explained in section
II above, HACCP implementation will be phased in based on establishment
size over a period of 18 to 42 months following the date of publication
of this final rule. FSIS originally proposed a single two-year delayed
effective date for its Salmonella performance standards. Many
commenters argued that it was not reasonable to hold all establishments
to the same effective date, and, furthermore, that it was more logical
to hold establishments to compliance with the standard after, rather
than before, HACCP was in place. This proposition also was strongly
endorsed by many people who attended an information briefing and public
meeting held by FSIS in Kansas City, Missouri, on May 22, 1995,
expressly for small meat and poultry establishments and small
businesses (60 FR 25869, May 15, 1995). They questioned, among other
things, the need for and wisdom of a common implementation date for
large and small establishments.
Harmonizing the effective dates with implementation of HACCP is
more consistent with the nature of the pathogen reduction standards as
measures of what establishments can and should achieve through HACCP-
based process control. It will bring 74% of the nation's slaughter
production of meat and poultry (by weight) under the performance
standard 18 months following publication of this final rule. It will
also facilitate the transition to HACCP, for both the FSIS workforce
and affected establishments, by requiring all establishments to meet
the performance standards as they implement HACCP.
Response to Comments
FSIS proposed to require that all meat and poultry slaughtering
establishments and establishments producing raw ground product conduct
daily microbial testing to determine compliance with interim targets
for the reduction of Salmonella. FSIS proposed to require a single
qualitative test per day, with daily results to be accumulated over
time to provide information regarding the performance of an
establishment's process and to collect data sufficient for process
control verification. Daily testing was considered the minimal sampling
necessary to detect process deviations within a realistic time frame.
The three issues most commonly raised by commenters concerning the
proposed microbial testing requirements were the proposed selection of
Salmonella as the indicator organism, the frequency of proposed
testing, and the disproportionate costs to small establishments. Some
commenters also argued that the regulatory approach was not justified
and exceeded FSIS's legal authority.
The Indicator Organism
Many commenters opposed the use of Salmonella as the indicator
organism, arguing that its low incidence in beef makes it a poor
indicator of pathogen reduction in the species, the positive/negative
test result is a weak measure of process control, and, compared to some
nonpathogenic alternatives such as generic E. coli, Salmonella tests
are more difficult, time-consuming, and costly. Others commented that
testing for Salmonella alone is unacceptable, as there is no direct
correlation between the presence of this organism and other pathogens
such as E. coli O157:H7, Listeria, and Campylobacter.
Various alternative indicator organisms were suggested, including
generic E. coli (biotype I), total plate counts, Enterobacteriaceae,
Total Viable Counts (TVC), and Aerobic Plate Counts (APC). Commenters
who recommended alternatives stated that tests for these organisms
would be better indicators for process control and fecal contamination
levels than tests for Salmonella. Still others requested that more
studies be conducted to determine which type of indicator organism
would be most useful for verifying process control.
Some commenters recommended retaining Salmonella as the target for
pathogen reduction, but suggested adding a requirement for generic E.
coli testing because it serves effectively as an indicator of fecal
contamination in all species. A minority of commenters supported the
proposed use of Salmonella as the indicator organism because of its
significance as a cause of foodborne illness and because there are
relatively simple tests available for detecting Salmonella. Some
commenters recommended requiring testing for Salmonella and additional
pathogens in selected species or products based on the degree of public
health risk posed by the pathogen. A number of consumer groups
requested a pathogen goal of zero for E. coli O157:H7.
These comments are generally addressed by the FSIS decisions to
require slaughter establishments to test for generic E. coli as a means
to verify process control for fecal contamination, and to have FSIS
conduct testing for Salmonella for pathogen reduction.
FSIS considers systematic measures to prevent and remove fecal
contamination and associated bacteria, coupled with microbial testing
to verify effectiveness, to be the state of the art in slaughter
establishment sanitation. Further, FSIS believes that testing for
generic E. coli is the appropriate and necessary means by which meat
and poultry slaughter
[[Page 38850]]
establishments must verify their process controls. FSIS reviewed
written comments received on the original proposal and comments made at
the scientific conferences and public meetings, as well as available
scientific data, and has decided to require slaughter establishments to
conduct testing for generic E. coli to verify process controls.
The Agency has concluded that each kind of testing serves an
important function. Both play a major part in the Agency's pathogen
reduction efforts, and working in unison will permit the Agency to use
its inspection resources more effectively, and efficiently, thereby
enhancing inspection.
E. coli testing for process control verification and Salmonella
testing to enforce the pathogen reduction performance standard both are
aimed at FSIS's objective to reduce the incidence of disease caused by
foodborne pathogens. However, E. coli testing and Salmonella testing
aim at the objective from different directions.
An ongoing screen for generic E. coli serves both the establishment
and FSIS as a means of verifying that a slaughter facility's process is
``in control'' with regard to prevention of fecal contamination of the
carcasses being produced. In other words, it becomes a marker for
verifying a slaughter establishment's adherence to the zero tolerance
for fecal contamination. Such testing provides a standard measure for
verification of process control at the critical slaughter stage of
production. Without such a standard measure, there is no objective
basis upon which either the establishment or FSIS can determine the
adequacy of process controls, from one establishment to another, in
preventing fecal contamination. It will permit establishments to make
ongoing adjustments or changes to their slaughter process when
necessary to meet the performance criteria. The test results will also
guide FSIS's ongoing inspection, permitting adjustments in intensity
and focus as appropriate.
Generic E. coli testing to verify process control alone, however,
does not adequately address legitimate public health concerns about
pathogenic bacteria in and on raw product. E. coli (except for certain
pathogenic subgroups) is not itself a cause of foodborne disease. It is
a ``surrogate marker'' or ``indicator'' for fecal contamination, which
in turn is a source of many pathogens that may contaminate products.
Fecal contamination, however, does not always correlate with the
presence of pathogens; high levels of E. coli may be present without
pathogens, and pathogens may be present without high E. coli levels.
Because testing for E. coli cannot serve as a surrogate for the
presence of Salmonella, FSIS's specific public health objective of
reducing nationwide Salmonella levels on raw meat and poultry products,
including raw ground products, requires a standard and a testing regime
that are directed at that pathogen.
The pathogen reduction performance standard for Salmonella must be
met by all inspected establishments producing raw meat and poultry
products. Agency testing for Salmonella is necessary for enforcement of
that requirement. Slaughter establishments' E. coli testing, a means
for verifying process control for fecal contamination, should promote
improved process controls which should, in turn, result in reductions
of Salmonella and other pathogens. But, E. coli testing cannot measure
actual reductions and control of Salmonella nor be the basis for Agency
enforcement of the pathogen reduction standards.
The test results from both kinds of testing are valuable to the
Agency in the shift to a HACCP-based regulatory regime, but their value
comes from the way they work together to verify the effectiveness of an
overall system of preventive process control. The Agency continues to
believe that pathogen reduction in inspected establishments requires
that establishments build into their operations preventive measures and
systems to reduce the potential for pathogens to be on products to
begin with, and that such systems must be establishment-produced and
establishment-specific. The Agency's HACCP and Sanitation SOP's
regulations are intended to do that. However, these regulations are not
self-enforcing. The Agency's inspection mandate does not permit it to
simply assume that an establishment's systems are in fact producing
uniformly safe and unadulterated products. Pathogen reduction will be
achieved instead by the combination of HACCP plans validated as
effective for pathogens of concern, E. coli testing by the
establishment to provide on-going verification of process control for
fecal contamination, and Salmonella testing by FSIS to enforce
compliance with the pathogen reduction performance standards.
Frequency and Cost of Testing
Many commenters questioned the proposed frequency of daily testing
for each species and for raw, ground products. The majority of
commenters who opposed daily testing stated that this testing
requirement would place an unfair cost burden and have a negative
economic impact on some establishments, especially small volume
establishments and establishments producing multiple species and
multiple ground products that would require multiple tests. These
commenters stated that under the proposed sampling methodology, a small
establishment could conceivably conduct more tests per day than a very
large establishment with a much higher production volume. Also
mentioned was the fact that many of these establishments do not have
on-site testing facilities and would have an additional cost of
shipping samples for testing.
To minimize the economic impact on establishments, especially small
establishments, some commenters suggested that FSIS should pay for
microbial testing. Others recommended less than daily testing or other
changes to the proposed sampling frequency. Various alternatives to the
proposed sampling protocol were mentioned, but the sampling scheme
recommended most often as the most equitable, and the one FSIS is
requiring, is one based on production volume.
Although many commenters requested less frequent testing than that
proposed, others supported the one sample per day testing requirement
as an efficient means of verifying process control. Still others
recommended testing even more frequently than once per day. These
commenters asserted that testing once a day is inadequate to verify
process control or to screen out product with pathogens. Their main
concern was that the proposed sampling frequency and moving sum
statistical procedure would allow inadequate process control to go
undetected, resulting in large quantities of suspect product being
produced; recommendations were made for a testing frequency more
proportional to an establishment's production volume.
Some commenters requested that exemptions from the proposed daily
microbial testing be made for small establishments and establishments
that have consistently complied with their HACCP programs. Others
requested exemptions for specific products including: raw ground meat
products; cured products; thermally processed canned foods; frozen
foods; boxed meat and beef and pork carcasses from other inspected
establishments; minor species (i.e., sheep, lamb, goats, equines,
guineas); and raw ground products to be further processed as fully
cooked, ready-to-eat items, while others stated that exemptions for
these items would be inappropriate.
[[Page 38851]]
FSIS has modified the proposal in response to these comments. As
explained above, FSIS is requiring E. coli testing in slaughter
establishments where the initial and primary opportunity for fecal
contamination occurs. FSIS is not requiring E. coli testing of
processed products. A more limited testing requirement is possible
because oversight of slaughter establishment verification testing for
E. coli is not the sole means relied upon by FSIS to detect or prevent
lack of process control. It is only one of many aspects of
establishment operations FSIS will inspect in assessing the adequacy of
an establishment's process controls. In particular, FSIS will
increasingly rely on its verification that HACCP systems are working as
intended. HACCP principles require establishments to identify CCP's,
monitor them to see that they are in control, and take appropriate
corrective action when monitoring detects a deviation. This is where
control must be exercised by the establishment and where any lack of
control will be detected in a establishment operating under a validated
HACCP system.
FSIS has reconsidered the proposed requirement of daily testing in
all slaughter establishments, in part because of the unnecessary and
disproportionate economic impact that would occur for some small
establishments. Instead, FSIS is requiring slaughter establishments to
test carcasses for generic E. coli at frequencies corresponding to
production volume. In addition, slaughter establishments will have 6
months, not just 3 months as proposed, after publication of the final
rule to begin testing carcasses for generic E. coli. Further, very low
volume establishments may not need to do more than one set of 13 E.
coli tests annually, and such establishments slaughtering more than one
species need not test both. These changes will significantly reduce the
cost impact of mandatory testing for small establishments, while
providing adequate and useful information to verify process control.
In addition to requiring testing for generic E. coli by slaughter
establishments at a frequency relative to the establishment's
production volume, Salmonella testing will be conducted by FSIS.
``Minor species,'' such as sheep, goats, equines, ducks, geese, and
guineas, are not being addressed at this time because the Agency is
addressing first the most commonly consumed foods under its
jurisdiction. FSIS intends to address how best to gather data on and
develop testing requirements and performance criteria and standards for
these other food animals at a future date.
Legal Authority for Testing Requirement
Several commenters have questioned FSIS's legal authority for the
proposed microbiological testing program. These comments are still
relevant despite the differences between the proposed and final rules
for microbiological testing.
The major change in the final rule is that FSIS is not adopting the
proposed Salmonella testing regimen. As proposed, results of a series
of establishment-conducted Salmonella tests would have been used to
accomplish two goals: to verify process control and to enforce the
prevalence targets for pathogens in raw products. Instead, FSIS is
promulgating separate provisions to address these two regulatory goals.
The first provision requires that slaughter establishments test
carcasses for E. coli so that the effectiveness of the establishment's
sanitation and process control measures can be assessed in an
objective, uniform manner. The second provision sets a pathogen
reduction performance standard to bring about reductions in the
prevalence of Salmonella on raw meat and poultry products. This
standard will be enforced by an FSIS-conducted testing program, and
will require establishments with prevalence of Salmonella above the
standard to change their operations to meet that standard. Failure by
an establishment to achieve the standard could result in Agency
sanctions, as discussed above. This standard will also encourage
innovation to reduce pathogens throughout the industry.
One commenter argues that, because this regulatory strategy is
precedent-setting, FSIS has a greater than usual burden of articulating
the legal basis for it. This commenter notes that the testing
regulation does not rely on a finding that the presence of the targeted
organisms causes specific lots of product to become adulterated, as is
the case with E. coli O157:H7 in ground beef. This commenter then
argues that FSIS is relying upon a vague ``sanitation theory'' as its
legal basis, and that the Agency has a greater duty to articulate its
legal basis when new regulations impose new kinds of costs, like
mandatory E. coli testing, or when the Agency is establishing a new
regulatory policy.
This commenter believes that FSIS reliance on a ``sanitation
theory'' is legally flawed because, if the Agency is unable to tell
establishments how to correct a failure to meet the established
targets, it cannot legally require microorganism testing, or impose
sanctions for failure to meet established standards.
FSIS has ample statutory authority under the FMIA and PPIA to
promulgate these microbiological testing provisions. The meat and
poultry inspection statutes mandate Federal regulatory oversight of
unusual intensity and comprehensiveness, and they provide the Secretary
broad rulemaking authorities to implement them. The primary goal of the
statutes is to prevent adulterated or misbranded meat and poultry
products from entering into commerce by inspecting meat and poultry
products and the establishments that produce them before the products
are introduced into commerce. Such inspections are supplemented by
compliance actions to remove adulterated or misbranded products from
commerce and to apply appropriate sanctions against violators of the
law. FSIS regulations under the FMIA and PPIA may be divided into two
categories: (1) regulations prescribing the conditions under which, and
the manner in which, mandatory inspections are conducted; and (2)
regulations directed more broadly at preventing adulteration or
misbranding of products, preparation of products in violation of the
law, and sale of such products in commerce.
These two regulatory categories are interrelated. The broader
category is similar to regulations imposed on foods generally by the
FDA under the Federal Food, Drug, and Cosmetic Act. However, FSIS
authorities also require compliance with the inspection provisions of
the acts and regulations by anyone slaughtering poultry or livestock,
or preparing poultry products, or meat or meat food products for use as
human food. Thus, the requirements that establishments must meet to
obtain inspection and to have products marked ``inspected and passed''
comprise a unique statutory scheme which provides the Secretary with
broad rulemaking authorities.
From their inception, the meat and poultry inspection laws have
recognized that sanitary conditions in establishments are critical to
the safety and wholesomeness of the products being produced. Any
product found to have been ``prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health'' is adulterated.
No product will be granted inspection or marked ``inspected and
passed'' unless the sanitary conditions and practices required by the
Secretary are maintained.
[[Page 38852]]
It is important to distinguish the statutorily required finding
that a product is not adulterated from the absence of a finding that it
is adulterated. Only products found not to be adulterated may be marked
``inspected and passed.'' Even if the evidence does not compel an
inspector to find that a product is adulterated, it, nonetheless, may
be enough to prevent him from finding that it is not adulterated. This
means that products may not be distributed for food use without the
affirmative determination that they are not adulterated. Products as to
which such an affirmative determination has not been made must be
retained at the establishment pending such determination. They are
being detained because they have not been inspected and passed, not
because they have been found to be adulterated.
Thus, FSIS clearly has the authority to require that establishments
slaughtering livestock or poultry conduct and record tests for E. coli
on carcasses to measure how well contamination is being avoided. These
tests provide information by which establishments may evaluate and
ensure the effectiveness of their sanitary procedures and related
process controls in preventing product contamination during slaughter
and dressing.
Although E. coli testing will not be used to determine the
disposition of inspected products, it will be an effective indicator of
the presence of fecal contamination that is not visible and therefore
not detectable by traditional inspection methods. It will also provide
FSIS with information necessary to determine how best to conduct
inspection to ensure that product is not being adulterated.
Similarly, FSIS has clear authority to establish a Salmonella
standard for producers of raw meat and poultry to reduce the public's
exposure to Salmonella and associated pathogens from inspected meat and
poultry products. The Salmonella standard, like the criteria for E.
coli on carcasses, is based on the national baseline prevalence of the
bacteria for the product of concern. However, unlike the E. coli
criteria, which are, in essence, guidelines, the Salmonella standard
must be met. Compliance will be determined by Agency testing.
FSIS is continuing its policy of permitting raw meat and poultry
products to be marked and labeled ``inspected and passed,'' despite the
known or suspected presence of some pathogenic bacteria. FSIS
recognizes that currently there is no available technology (with the
possible exception of irradiation) to ensure that raw product bears no
pathogenic microorganisms.
However, there is overwhelming evidence that raw meat and poultry
products are frequently contaminated with pathogens and expose
consumers to avoidable and unacceptable risks of foodborne illness.
FSIS's statutory mandate to protect consumers from adulterated product
is not limited to actions associated with inspection. The Secretary may
also regulate how meat and poultry products are stored and handled by
anyone who buys, sells, freezes, stores, transports, or imports them,
to ensure they are not misbranded or adulterated when delivered to the
consumer.
The new pathogen reduction standards for Salmonella are necessary
to establish that raw product is being produced under sanitary
conditions, has not been prepared, packed or held under insanitary
conditions, and is not for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food.
The fact that the new performance standards and guidelines do not
specify how the E. coli process control verification performance
criteria or the Salmonella pathogen reduction standard must be met does
not undercut the reasonableness or the legal basis of either testing
program. Process control and the production of product that is not
adulterated is the responsibility of the establishment, not the
government. The Agency is responsible for establishing and enforcing
reasonable standards; it intends to give the industry the maximum
flexibility to decide how best to meet such standards. It does not
intend to regulate or prescribe how the standards are to be met. FSIS
will provide guidance and assistance to the industry, especially small
businesses. But it is not legally obliged to provide technical services
to establishments in finding the most efficient and effective way to
operate within the E. coli criteria and to meet the Salmonella
reduction standard.
In summary, FSIS has concluded that the E. coli testing program and
the Salmonella reduction standard are fully supported by the FMIA and
PPIA.
Performance Standards for Process Control
A related comment asserted that FSIS's proposed Salmonella standard
was not a standard at all, but instead was merely an unenforceable
criterion because its violation would not alone support seizure or
condemnation of products. FSIS agrees with the principle that a
regulatory standard should be enforceable, but does not agree that a
regulatory ``standard'' must be limited to product-specific
requirements, or to enforcement by seizure or condemnation of products.
The Agency acknowledges that historically it has used the term
``standard'' normally to refer to regulations concerning particular
products, e.g., standards of identity regulations, but notes that
current government-wide regulatory reform efforts stress the use of
``performance standards'' to describe the desired focus of government
regulations generally. FSIS intends now to issue regulations consistent
with the notion behind ``performance standards,'' that to the extent
possible regulations should tell regulated entities what they must
achieve to comply with the law, while providing maximum flexibility
regarding how to achieve the standard. Thus, FSIS agrees that one test
of a ``standard'' might be that violation of that requirement alone
supports some sort of regulatory sanction, but does not agree that
``standards'' should be limited to product-specific regulations or to
enforcement actions directed at specific products. The FMIA and PPIA do
not limit the Agency to product-specific regulations and enforcement
activities, and for reasons fully discussed earlier in this preamble,
the Agency has concluded that standards directed at processes are, at
this time, the only practical way in which to effectively address the
hazard presented by microbiological pathogens on raw meat and poultry
products.
Basis for Target Levels
Some commenters questioned the validity of microbial target levels
established by FSIS, while others supported FSIS national baseline
studies as an effective way to evaluate industry performance. After
careful review, the Agency considers it reasonable and appropriate to
use the distribution of results observed for each animal species in the
FSIS baseline surveys as the basis for both the E. coli criteria and
the pathogen reduction performance standard for Salmonella. These are
currently the best available data on the nationwide prevalence and
level of microbial contamination of raw meat and poultry products. The
data demonstrate that the E. coli process control verification criteria
and the Salmonella pathogen reduction standard are being achieved by
many establishments with today's technology and therefore are
achievable by all establishments.
FSIS Nationwide Microbiological Baseline Data Collection Programs
and its Nationwide Microbiological Surveys provide similar data, but
the
[[Page 38853]]
``Programs'' generally involve more extensive sampling over a longer
period, generally 12 months, than the ``Surveys'', which are generally
limited to 6 months of data collection. They both have provided data
for an ongoing microbial profile of carcasses and other raw meat and
poultry products for selected microorganisms or groups of
microorganisms of various degrees of public health concern of value as
indicators of general hygiene or process control.
As explained above, FSIS plans to revise the performance criteria
and standards as more current baseline data become available from
future baseline surveys, through establishment E. coli testing, through
FSIS Salmonella testing, or from other FSIS testing that may be
appropriate for establishing criteria and standards.
Although the majority of commenters focused on the issues mentioned
above, a number of others addressed various aspects of the proposed
rule such as microbial testing methodology, the concept of end product
testing, the role of FSIS personnel in test verification, enforcement
actions for non-compliance, and laboratory qualifications.
Methodology for Meeting Targets
Some commenters raised objections to use of the ``moving sum''
statistical procedure for determining when microbial testing results
are within the process control. Moving sum procedures are recognized in
the field of statistical quality control. The American National
Standard ``Guide for Quality Control Charts'' <SUP>11 identifies two
principal uses of such charts: assisting judgment as to whether a state
of control exists and attaining and maintaining control. In order to
judge whether a state of control exists, operators must analyze
``collectively an accumulation of quality data.'' In the proposed
regulation FSIS took this view of the purpose of the moving sum
procedure: establishments would need to verify that a state of control
exists with respect to the interim target set by the Agency. FSIS did
not claim, however, that the procedure would be useful for the second
purpose, attaining and maintaining control. That requires more timely
and probably more intense monitoring of process parameters at CCP's.
---------------------------------------------------------------------------
<SUP>11 American National Standard ANSI Z1.1-1985. ``Guide for
Quality Control Charts.'' American Society for Quality Control.
Milwaukee, WI.
---------------------------------------------------------------------------
The proposed approach to use testing to measure process control was
designed to inform establishments how they are currently operating with
respect to the relevant target, and to help them track progress toward
meeting that target. A simple plot of the moving sum chart would give
them sufficient feedback for this purpose.
Some commenters recommended that the moving window verification
program should use a 90% probability criteria, rather than 80%, to
reduce the possibility of the testing procedure erroneously identifying
an establishment as not meeting the pathogen target. The Agency notes
that the moving sum procedure was designed to measure effectiveness of
process control with respect to an interim performance standard (called
a target in the proposal) based on current industry performance (as
determined by a baseline study). This measure was intended to be the
first step in holding establishments accountable for meeting acceptable
levels of performance. As such, the Agency wanted to be able to readily
identify establishments operating above the target and wanted to
provide an incentive for establishments to produce at levels better
than (below) the target. Giving establishments producing at the target
only an 80% chance of passing was expected to promote this. Giving
establishments producing at the target a higher chance of passing
(e.g., 95%) would reduce both the incentive to do better and the
ability to detect establishments above the target.
Sample Size
Others specifically addressed the proposed sample size,
recommending that the same number of samples be used for all species.
Not all species have the same risks of failure, in part because of the
varied incidence of pathogens, as was determined in FSIS's baseline
surveys. The proposed sampling rate was the same for all
establishments, one per day. Thus the sampling was the same for all
establishments, only the rules for interpreting results were different.
The number of results included in the window differed by product class
because the target percents positive differed by product class. It was
necessary to employ different-sized windows to maintain a fixed
probability of passing (80%) at the target for all product classes
while choosing as short a window as possible and allowing at least one
positive in the window.
Testing Methodology
Other commenters asked for clarification on testing methodology.
Some remarked that using a sponge or swab method to sample carcasses is
preferable to the proposed excision method because the proposed method
is time consuming, cumbersome, and expensive, and it may mutilate and
contaminate the carcass. The Agency agrees and has elected to use non-
destructive sampling methods.
Others asked for clarification of enforcement actions that would
result from an establishment not meeting its microbial targets. How the
rule will be enforced is addressed above.
Role of Inspectors
Still others asked about the role of inspection personnel in
verification testing and expressed concern about the amount and type of
training inspection personnel would receive to analyze test results.
The final rule makes slaughter process control verification testing
(E. coli) the responsibility of establishments slaughtering livestock
or poultry, although FSIS inspectors may also collect samples for E.
coli testing as needed to carry out their oversight responsibilities.
FSIS personnel sampling carcasses for Salmonella to ensure that
establishments are meeting the pathogen reduction performance standard
will send the samples to an Agency laboratory for analysis. FSIS
personnel have been involved in collection of samples for FSIS's
baseline surveys, and have been trained and are highly qualified to
collect samples for this regulatory program. Inspectors will work with
other program officials, including scientifically trained experts, in
analyzing test results and making appropriate regulatory decisions.
Inspectors will receive training to prepare them for their role in this
process.
Laboratories
Some commenters asked for clarification regarding qualifications
for in-house and outside laboratories. They stated that laboratories
should be required to use standardized techniques for analyzing test
results.
The microbiological test method used by the establishments must be
AOAC validated techniques, or other methods validated by a scientific
body in collaborated trials against the three tube most probable number
(MPN) method and agreeing with the 95 percent upper and lower
confidence interval, as discussed in the E. coli Methods Section.
Establishments are responsible for the accuracy of the tests of their
samples. If the samples are not analyzed by the establishment, the
establishment, perhaps in concert with a trade association, should
ensure that the laboratory it chooses is reputable and
[[Page 38854]]
adheres to a Quality Control/Quality Assurance Program.
Alternative Sampling Under HACCP
Other commenters stated that the proposed microbial testing system
does not reward very clean establishments by granting reasonable
reductions in testing when significant periods are pathogen free. They
recommended that once a facility has implemented its HACCP program, the
required frequency for mandatory microbial testing should be reduced or
eliminated altogether.
In this final rule, a slaughter establishment successfully
operating under a validated HACCP plan may reduce the specified
sampling frequency as long as the alternative sampling plan is an
integral part of the establishment's verification procedures for its
HACCP system. FSIS does, however, reserve the right to determine that
the alternative frequency is inadequate to verify the effectiveness of
the establishment's process controls. In that case, FSIS would notify
the establishment in writing of its finding, advise that the frequency
specified in the regulation must be maintained, and specify any
conditions an acceptable alternative frequency would have to meet to be
found acceptable to the Agency.
Relationship to HACCP
Finally, some commenters stated that the proposed end-product
testing is inconsistent with HACCP principles and that establishments
should decide for themselves through hazard analysis whether testing is
needed and at what frequency. Others objected to the concept of end-
product testing because it only measures effectiveness over a small
percentage of a production lot and has limited value in measuring the
overall success of a HACCP plan. Still others concluded that placing an
emphasis on end-product testing gives consumers a false sense of
confidence about the safety of meat and poultry products. A few
commenters were concerned about product liability due to product
recalls stemming from test results.
The objective of the generic E. coli testing is to verify that
process control has been maintained by the establishment throughout the
slaughter and dressing process and that resultant carcasses are
produced hygienically. If processes are under control for E. coli, the
potential presence of enteric pathogens will be reduced. End-product
verification testing of this kind is a well recognized component of
HACCP-based process control.<SUP>12 The goal of FSIS's Salmonella
testing program is to verify that pathogen reduction performance meets
current standards in each establishment and thereby effect a nationwide
reduction in the incidence of that organism and other enteric pathogens
on raw meat and poultry products. The end of production is the only
point that reflects all steps in the production process and,
ultimately, all elements of the HACCP system. The seventh HACCP
principle is verification that the HACCP system is working; one cannot
verify that HACCP is working in slaughter establishments (controlling
fecal contamination/pathogens) without some end-product testing, so
end-product testing is not inconsistent with HACCP principles. The two
different kinds of testing programs: (1) E. coli testing by
establishments to verify control of fecal contamination; and (2)
Salmonella testing by FSIS to hold establishments accountable for
meeting pathogen performance standards, are both forms of end-product
testing that FSIS considers consistent with HACCP.
---------------------------------------------------------------------------
\12\ National Advisory Committee on Microbiological Criteria for
Foods. 1994. ``Hazard Analysis and Critical Control Point Systems.''
FSIS, USDA.
---------------------------------------------------------------------------
End-product testing as part of an overall system of HACCP-based
process control and performance standards should not give consumers a
false sense of confidence about the safety of meat and poultry
products. FSIS recognizes that limited end-product testing alone
provides little assurance of safety, but, as part of a process control
system, appropriate end-product testing brings rigor and accountability
to the system and should appropriately increase consumer confidence in
the safety of products. By requiring HACCP, FSIS is in fact moving away
from sole reliance on end-product assessments for lot acceptance, an
approach that is the opposite of the HACCP system approach to food
safety. FSIS recognizes that producing safe food requires preventing
hazards throughout the process rather than relying solely on end-
product testing to ensure safety. Establishments' liability to civil
lawsuits should not be adversely affected by this rule precisely
because it is an establishment's process, not individual lots of
product, that is being assessed, for inspection purposes, on the basis
of this testing.
V. Other Issues and Initiatives
Antimicrobial Treatments
FSIS proposed that all slaughter establishments apply at least one
antimicrobial treatment or other approved intervention to livestock and
poultry carcasses prior to the chilling or cooling operation. Proposed
treatment methods included chlorine compounds, hot water, and any
antimicrobial compound previously approved by FSIS and listed in the
meat or poultry regulations. Product prepared for export to countries
that restrict or prohibit the use of antimicrobial treatments would
have been exempted from this requirement upon application to the
Administrator.
While most commenters generally agreed that antimicrobial
treatments could play an important role in reducing contamination with
pathogenic microorganisms in slaughter establishments, many commenters
opposed mandating such treatments. The commenters argued that mandating
the use of antimicrobial treatments in slaughter operations would not
be consistent with the HACCP philosophy and the overall shift by FSIS
to greater reliance on performance standards.
FSIS agrees with these commenters and has decided not to mandate
the use of antimicrobial treatments in slaughter establishments. FSIS
continues to believe that slaughter establishments will find that these
treatments can play a useful role in reducing pathogens and improving
the safety of meat and poultry products. Rather than mandating specific
antimicrobial treatments, FSIS will rely on other requirements in this
final rule to ensure that slaughter establishments are achieving an
acceptable level of performance in controlling and reducing harmful
bacteria on raw product.
The principle of using antimicrobial treatments as an intervention
to control pathogens on meat and poultry carcasses was strongly
endorsed by most commenters. However, few agreed that the treatments
should be mandatory. A majority of commenters recommended that
antimicrobial treatments be voluntary interventions. Establishments
would decide if antimicrobial interventions were needed to control
specific hazards at one or more critical control points in the
slaughter process.
Similarly, a number of commenters tied antimicrobial treatments to
microbial testing. They argued that carcass treatments should not be
required in establishments that consistently meet or exceed performance
standards for microbial contamination.
Commenters said FSIS should focus its regulatory efforts on
measurable, attainable goals and not on prescriptive requirements for
particular processing steps. Several commenters emphasized the need for
``whole system'' interventions instead of single
[[Page 38855]]
techniques such as antimicrobial treatments. They said these
interventions work best when they are tailored to species and product
hazards, individual establishment configurations, and processing
methods. Furthermore, some commenters cited a danger that
establishments and inspection personnel would focus on the treatment
function itself instead of broader food safety goals.
FSIS generally agrees with these comments. FSIS has concluded that
its food safety goals can be achieved more effectively and more
efficiently by requiring HACCP-based process control combined with
appropriate performance criteria and standards than by mandating
specific interventions, such as antimicrobial treatments. New
technological interventions will play a significant role in reducing
the risk of foodborne illness and should be adopted as part of an
overall system of HACCP-based process control. FSIS expects that such
treatments may be used by establishments to meet the process control
performance criteria and pathogen reduction performance standards FSIS
is adopting in this final rule.
A few commenters opposed mandating antimicrobial treatments because
they believed their use would allow for correction of sloppy carcass
dressing procedures. These commenters argued that antimicrobial
treatments, whether mandatory or voluntary, emphasize post-
contamination clean-up rather than prevention.
FSIS also received many comments which addressed the four proposed
antimicrobial treatment methods. Many commenters stated that FSIS
should not restrict establishments to these particular antimicrobial
interventions.
A variety of commenters addressed technology issues concerning the
proposed treatment methods themselves. Many said that too few studies
have been conducted to show which interventions are most effective and
efficient for specific pathogens associated with particular species in
individual slaughter establishment configurations. Some argued that the
studies FSIS cited in its proposal were too narrow and did not
adequately demonstrate effectiveness. They said additional studies were
needed to determine the practicality, efficacy, and expense of various
antimicrobial treatments in commercial settings. In addition, some
commenters were concerned that insufficient research was available on
whether the elimination of competitive micro flora would allow
uninhibited growth of pathogenic bacteria.
Individual antimicrobial techniques were also criticized. For
example, hot water sprays were said to pose dangers to establishment
personnel applying the treatments at temperatures necessary for
effectiveness. Hot water sprays raise carcass temperatures with
consequent melting of surface fat in some species, contribute to
quality defects such as change in product color and partial cooking,
and result in higher energy costs. Commenters recognized, however, that
hot water was the only currently available nonchemical intervention
that could be implemented at comparatively low cost. Other commenters
criticized lactic, acetic, and citric acid solution sprays because they
have low effectiveness as a treatment against E. coli O157:H7. The
possible carcinogenic effects of chlorine were also mentioned, as were
concerns about water reuse and possible environmental effects from
spray effluents.
Commenters also suggested a variety of alternative antimicrobial
interventions that could be used by establishments. These interventions
included irradiation and radiation-emitting electronic devices such as
x-rays and linear accelerators; high-energy ultraviolet light; pulsed
light, sonic, infrasonic, and ultrasonic emitters; chemicals such as
copper sulfate in the pentahydrate form, chlorine dioxide, and hydrogen
peroxide; procedures such as pre-evisceration washes, water curtains,
counter current or counter flow scalders, the Peroxi bicarb process,
automatic warm fresh water rinses, ozonated water, steam
pasteurization, steam vacuuming, hot wax dipping, and singeing.
A number of commenters also suggested that FSIS establish protocols
to evaluate various forms of antimicrobial procedures and treatments.
FSIS could then publish a regularly updated list of acceptable
treatments and provide guidelines for their use in a commercial
setting. It was argued that this process would give establishments the
flexibility to implement any interventions they deem necessary. Others
said FSIS should set up a predetermined protocol for antimicrobial
agents or an expedited review process for new technologies.
FSIS agrees that issues of effectiveness, product and worker
safety, product quality, interference with inspection, and
environmental impact can be raised about most food safety
interventions, including antimicrobial treatments. Therefore, to
facilitate industry development of new technologies, FSIS has
established a process that will facilitate this development.
On May 25, 1995, FSIS published a notice in the Federal Register
(60 FR 27714) that presented guidelines for preparing and submitting
experimental protocols to FSIS for use by establishments wishing to
conduct trials of new technologies and procedures. In that notice, FSIS
confirmed its long-standing commitment to foster innovative
technologies and procedures that more effectively protect meat and
poultry products from microbiological and other hazards. Specifically,
FSIS encouraged the development of efficacious, practical and
manageable technologies and procedures by establishments.
FSIS also published guidelines (FSIS Directive 10,700.1) for
establishments to use for submitting written proposals and protocols to
FSIS for approval to conduct experiments. Agency approval is required
in cases where the intended technology, procedure or process may affect
(1) product safety or lead to economic adulteration, (2) worker safety,
(3) environmental safety, or (4) inspection procedures.
Similarly, FSIS published a proposed rule in the Federal Register
(60 FR 67459; December 29, 1995) that will facilitate the review and
approval of substances intended for use in or on meat and poultry
products. Under the proposed procedures, FSIS would no longer issue its
own regulations listing substances it finds suitable for use in meat
and poultry products. Instead, FDA's regulations would specify whether
a substance approved for use in foods under the Federal Food, Drug, and
Cosmetic Act may be used in or on meat or poultry products.
Many commenters stated that antimicrobial interventions should be
permitted at any stage in the slaughter process: live animal, pre-hide
removal, pre- or post-carcass wash, pre- or post-chill, or just prior
to fabrication.
Some commenters argued that the proposed treatments would seriously
compromise the Kosher ritual salting process, while others said the
interventions would conflict with Confucian and Buddhist-style poultry
prepared for religious rites.
A number of commenters questioned the relationship between FSIS's
policy on zero tolerance for fecal contamination and its antimicrobial
treatment proposal. In particular, they were concerned about where in
the process zero tolerance would be measured.
Finally, several commenters requested a practical definition of
``feces'' as a means to resolve disagreements between inspectors and
establishment personnel about trimming contamination.
[[Continued on page 38856]]