[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38806-38989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17837]



[[Page 38805]]


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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

  Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules 
and Regulations  

[[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.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is establishing 
requirements applicable to meat and poultry establishments designed to 
reduce the occurrence and numbers of pathogenic microorganisms on meat 
and poultry products, reduce the incidence of foodborne illness 
associated with the consumption of those products and provide a new 
framework for modernization of the current system of meat and poultry 
inspection. The new regulations (1) require that each establishment 
develop and implement written sanitation standard operating procedures 
(Sanitation SOP's); (2) require regular microbial testing by slaughter 
establishments to verify the adequacy of the establishments' process 
controls for the prevention and removal of fecal contamination and 
associated bacteria; (3) establish pathogen reduction performance 
standards for Salmonella that slaughter establishments and 
establishments producing raw ground products must meet; and (4) require 
that all meat and poultry establishments develop and implement a system 
of preventive controls designed to improve the safety of their 
products, known as HACCP (Hazard Analysis and Critical Control Points).

DATES: Effective Date: July 25, 1996, however these rules are not 
applicable until the dates listed below.
    Applicability dates: (1) The HACCP regulations set forth in 9 CFR 
Part 417 and related provisions set forth in 9 CFR 304, 327, and 381 
parts will be applicable as follows:
     In large establishments, defined as all establishments 
with 500 or more employees, on January 26, 1998.
     In smaller establishments, defined as all establishments 
with 10 or more employees but fewer than 500, on January 25, 1999.
     In very small establishments, defined as all 
establishments with fewer than 10 employees or annual sales of less 
than $2.5 million, on January 25, 2000.
    (2) The Sanitation SOP's regulations set forth in 9 CFR 416 will be 
applicable on January 27, 1997.
    (3) The E. coli process control testing regulations set forth in 9 
CFR 310.25(a) and 381.94(a) will be applicable on January 27, 1997.
    (4) The Salmonella pathogen reduction performance standards 
regulations set forth in 9 CFR 310.25(b) and 9 CFR 381.94(b) will be 
applicable simultaneously with applicability dates for implementation 
of HACCP.
    Comments: Comments on specified technical aspects of the final 
regulations must be received on or before September 23, 1996. With 
respect to the HACCP final regulations, FSIS requests comments by 
November 22, 1996.

ADDRESSES: Submit one original and two copies of written comments to: 
FSIS Docket Clerk, DOCKET #93-016F, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 4352, 1400 Independence 
Avenue, S.W., Washington, DC 20250-3700. All comments submitted on this 
rule will be available for public inspection in the Docket Clerk's 
Office between 8:30 a.m. and 1:00 p.m., and 2:00 p.m. and 4:30 p.m., 
Monday through Friday. The references and baseline surveys cited in 
this document are available for inspection in the FSIS Docket Room.

FOR FURTHER INFORMATION CONTACT: (1) GENERAL: Dr. Judith A. Segal, 
Director, Policy, Evaluation, and Planning Staff, (202) 720-7773; (2) 
MICROBIAL TESTING: Patricia F. Stolfa, Acting Deputy Administrator, 
Science and Technology, (202) 205-0699.

SUPPLEMENTARY INFORMATION:

Obtaining Copies of This Document:

    An electronic version of this document is available on the Internet 
from the Federal Register at www.access.gpo.gov/su__docs/aces/
aces140.html. Paper or diskette copies of this document may be ordered 
from the National Technical Information Service (NTIS), U.S. Department 
of Commerce, 5285 Port Royal Road, Springfield, VA 22161. For a 
complete copy of this document orders must reference NTIS accession 
number PB96-177613 (paper copy) and PB96-502166 (disk copy). For a copy 
of the preamble and rule, the individual appendices, and the impact 
assessment reference the following NTIS accession numbers: PB96-177621 
(preamble and rule only), PB96-177639 (Appendix A), PB96-177647 
(Appendix B), PB96-177654 (Appendix C), PB96-177662 (Appendix D), PB96-
177670 (Appendix E), PB96-177688 (Appendix F), PB96-177696 (Appendix 
G), and PB96-177704 (impact assessment). For telephone orders or more 
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:
     Hazards that could result in foodborne illness arise at 
each stage in the farm-to-table continuum: animal production and 
slaughter, and the processing, transportation, storage and retail, 
restaurant or food service sale of meat and poultry products. Each 
stage presents hazards of pathogen and other contamination and each 
provides opportunities for minimizing the effect of those hazards.
     Those in control of each segment of the farm-to-table 
continuum bear responsibility for identifying and preventing or 
reducing food safety hazards that are under their operational control.
     The Agency's public health mandate requires that it 
address foodborne illness hazards within each segment of the food 
production chain and implement or encourage preventative strategies 
that improve the whole system.
    FSIS remains committed to a farm-to-table food safety strategy 
based on these principles. To address hazards arising within slaughter 
and processing establishments, FSIS proposed and is adopting in this 
rule significant new regulatory measures. Improving food safety before 
the animals reach slaughter establishments will require a different 
approach. The preamble to the Pathogen Reduction/HACCP proposal stated 
that FSIS will be cooperating with animal producers, scientists in 
academia, the Animal and Plant Health Inspection Service and other 
government agencies to develop and foster food safety measures that can 
be taken on the farm and through marketing channels to decrease public 
health hazards in animals presented for slaughter. Within this context, 
the voluntary application of food safety assurance programs based on 
HACCP principles can be useful in establishing risk reduction practices 
on the farm and through intermediate marketing stages to control and 
reduce pathogen hazards at slaughter.
    FSIS expects, within the limits of available resources, to serve as 
a facilitator and coordinator of research and other activities designed 
to encourage development and implementation of animal production 
technologies and practices that can improve food safety. FSIS also 
intends to offer its expertise to assist State health and agricultural 
officials, when requested, during outbreak investigations of foodborne 
illnesses to learn more about potential risk factors. FSIS does not 
intend nor is FSIS authorized, to mandate production practices on the 
farm, but does expect that continued public concern about foodborne 
pathogens and adoption of HACCP and food safety performance standards 
within slaughter and processing establishments will increase incentives 
for improving food safety practices at the animal production level.
    The post-processing transportation, storage, and retail, restaurant 
or food service sectors are also important links in the chain of 
responsibility for food safety. In these areas, FDA and State and local 
governments share authority and responsibility for oversight of meat 
and poultry products outside of official establishments. FSIS and FDA 
are collaborating in the development of standards governing the safety 
of potentially hazardous foods, including meat and poultry, eggs, and 
seafood, during transportation and storage, with particular emphasis on 
proper cooling to minimize the growth of pathogenic microorganisms, and 
on disclosure of prior cargoes in transport vehicles. This effort will 
be discussed in a forthcoming advance notice of proposed rulemaking.
    In the retail, restaurant and food service areas, FSIS and FDA are 
working in concert with State and local food regulatory officials to 
foster adoption of updated, uniform, science-based standards, including 
mandates for HACCP process controls for high-risk processing and 
packaging operations. State and local authorities have assumed primary 
responsibility for food safety oversight of retail, restaurant and food 
service operations, but FSIS and FDA, working through the Conference on 
Food Protection and other collaborative mechanisms, provide expertise 
and leadership to support local authorities and foster development of 
sound food safety standards and practices nationwide. FSIS is 
cooperating with FDA to update the Food Code, a set of model ordinances 
recommended for adoption by the

[[Page 38811]]

States, to ensure meat and poultry safety is adequately addressed in 
retail, restaurant and food service settings.
    Even as progress is made in reducing contamination of food by 
harmful bacteria and other safety hazards at the production, processing 
and subsequent commercial stages of the farm-to-table continuum, it 
will remain critically important that individual consumers follow safe 
food handling practices. Proper storage, preparation, and cooking of 
meat and poultry products are essential to achieving the goal of 
reducing the risk of foodborne illness to the maximum extent possible. 
FSIS intends to augment its food handler and consumer education efforts 
by expanding its collaboration with the meat and poultry industry, 
other government agencies, consumer and public interest groups, 
educators, and the media to effectively develop and deliver food safety 
education and information to the public.
    The HACCP requirements and other regulations FSIS is adopting in 
this final rule will ensure that inspected establishments are taking 
appropriate measures to reduce hazards at critical stages where the 
risk of initial contamination is greatest. The public health benefits 
of these measures, however, are only a part of a comprehensive food 
safety strategy that seeks to minimize hazards throughout the farm-to-
table continuum.

General Overview of the Comments and the Final Rule

HACCP and Performance Standards
    The FSIS proposal to require adoption of HACCP in meat and poultry 
establishments was widely endorsed by comments from large and small 
businesses, the scientific and public health communities, consumers, 
and public interest organizations. Commenters strongly supported the 
concept that meat and poultry establishments should systematically 
build science-based food safety measures into their production 
processes following the seven HACCP principles developed by the 
National Advisory Committee on Microbiological Criteria for Food 
(NACMCF). Although many commenters requested clarification of how FSIS 
intends to implement HACCP and conduct inspection under HACCP, the 
principal critical comments concerned costs and the practicality of 
using HACCP in very small establishments. FSIS is adopting the HACCP 
requirements, based on the NACMCF principles, essentially as proposed.
    From a food safety standpoint, the most important objective of this 
rulemaking is to build into food production processes, and into the 
system of FSIS regulation and oversight, effective measures to reduce 
and control harmful bacteria on raw meat and poultry products. This 
will not by itself solve the problem of foodborne illness associated 
with meat and poultry products. Effective measures are needed 
throughout the farm-to-table continuum, but this rulemaking will fill 
the most critical gap in the current system of meat and poultry 
inspection. While products sold in cooked or otherwise ready-to-eat 
forms are currently subject to controls and regulatory standards 
designed to eliminate harmful bacteria, products sold raw are not 
currently subject, as a general matter, to any such controls or 
standards.
    FSIS has concluded that HACCP-based process control, combined with 
appropriate food safety performance standards, is the most effective 
means available for controlling and reducing harmful bacteria on raw 
meat and poultry products. HACCP provides the framework for industry to 
set up science-based process controls that establishments can validate 
as effective for controlling and reducing harmful bacteria. Performance 
standards tell establishments what degree of effectiveness their HACCP 
plans will be expected to achieve and provide a necessary tool of 
accountability for achieving acceptable food safety performance. 
Science-based process control, as embodied in HACCP, and appropriate 
performance standards are inextricably intertwined in the Agency's 
regulatory strategy for improving food safety. Neither is sufficient by 
itself, but, when combined, they are the basis upon which FSIS expects 
significant reductions in the incidence and levels of harmful bacteria 
on raw meat and poultry products and, in turn, significant reductions 
in foodborne illness.
    The proposed interim targets for pathogen reduction based on 
Salmonella generated widely diverse comments. Commenters supported the 
goal of pathogen reduction, and many recognized some role for microbial 
testing and the need for a microbial reduction target or performance 
standard. Some commenters argued that the proposed testing regimen (a 
single sample per species per day) was inadequate for its purpose in 
large establishments, while others argued it was too burdensome in 
small establishments. Some commenters specifically supported the 
proposed Salmonella reduction targets and the daily testing 
requirements. Many, however, criticized the proposed testing 
requirements and considered Salmonella testing less useful than generic 
E. coli testing as an indicator of whether process controls in 
slaughter establishments are effectively preventing fecal 
contamination, the primary pathway for pathogen contamination. At the 
scientific conference on the role of microbial testing held in 
Philadelphia, broad support also was expressed for using generic E. 
coli rather than Salmonella as a process control indicator.
    Based on public comments, FSIS has modified its approach to 
establishing microbial performance standards. FSIS believes that 
testing for generic E. coli is the appropriate and necessary means by 
which meat and poultry slaughter establishments must verify their 
process controls. FSIS reviewed written comments received on the 
original proposal and comments made at the scientific conferences and 
public meetings, as well as available scientific data, and has decided 
to require slaughter establishments to conduct testing for generic E. 
coli to verify process controls. Establishments will be required to 
test for E. coli at a frequency that takes into account their volume of 
production. FSIS is seeking additional scientific and economic data 
that may help to further improve the E. coli testing protocols.
    FSIS is also establishing performance criteria based on national 
microbiological baseline surveys. The criteria are not regulatory 
standards but rather provide a benchmark for use by slaughter 
establishments in evaluating E. coli test results. Test results that do 
not meet the performance criteria will be an indication that the 
slaughter establishment may not be maintaining adequate process control 
for fecal contamination and associated bacteria. Such results will be 
used in conjunction with other information to evaluate and make 
appropriate adjustments to ensure adequate process control for fecal 
contamination and associated bacteria.
    FSIS is also establishing pathogen reduction performance standards 
for Salmonella that will require all slaughter establishments to reduce 
the incidence of Salmonella contamination of finished meat and poultry 
carcasses below the national baseline prevalence as established by the 
most recent FSIS national microbiological baseline data for each major 
species. FSIS will conduct Salmonella testing in slaughter 
establishments to detect whether they are meeting the pathogen 
reduction performance standards, and will require corrective action or 
take regulatory

[[Page 38812]]

action, as appropriate, to ensure establishments are meeting the 
pathogen reduction standards.
    Pathogen-specific performance standards for raw products are an 
essential component of the FSIS food safety strategy because they 
provide a direct measure of progress in controlling and reducing the 
most significant hazards associated with raw meat and poultry products. 
The Salmonella standards being established in this final rule, which 
are based on the current national baseline prevalence of Salmonella 
(expressed as a percentage of contaminated carcasses), are a first step 
in what FSIS expects to be a broader reliance in the future on 
pathogen-specific performance standards. FSIS plans to repeat its 
baseline surveys and collect substantial additional data through other 
means and, on that basis, adjust the Salmonella performance standards 
and possibly set standards for additional pathogens, as appropriate. 
Also, FSIS will continue to explore establishing pathogen-specific 
performance standards based on the levels of contamination (i.e., the 
number of organisms) on a carcass. Future FSIS efforts on such 
performance standards will reflect the fact that achieving the food 
safety goal of reducing foodborne illness to the maximum extent 
possible will require continuous efforts and improvement over a 
substantial period.
Sanitation SOP's, Antimicrobial Treatments, and Cooling Requirements 
for Raw Meat and Poultry Products
    Comments generally supported the objectives of the three near-term 
measures for raw meat and poultry products proposed by FSIS, Sanitation 
SOP's, antimicrobial treatments, and carcass cooling standards, and 
most commenters agreed that Sanitation SOP's should be a required 
element of any meat and poultry establishment's food safety program. 
Many commenters objected, however, to FSIS mandated antimicrobial 
treatments in slaughter establishments and carcass cooling standards 
for red meat prior to the implementation of HACCP. Although most 
comments generally agreed that antimicrobial treatments would play an 
important role in many slaughter establishments' HACCP plans, and that 
proper carcass cooling would be an essential part of any HACCP plan for 
raw meat and poultry products, these commenters argued that mandating a 
particular approach to antimicrobial treatments or carcass cooling 
would be inconsistent with the HACCP concept that establishment 
management is responsible for designing a system of controls 
appropriate for each establishment. They also argued that mandating 
antimicrobial treatments was unnecessary if establishments were 
required to meet pathogen reduction performance standards. Similarly, 
with respect to the proposed requirement that establishments cool red 
meat carcasses following specific cooling rate standards prescribed by 
FSIS, commenters argued that HACCP, reinforced by performance 
standards, would ensure proper carcass cooling. Many commenters said 
that the specific time-and-temperature requirements proposed by FSIS 
were often not feasible, posed worker safety concerns, and would divert 
effort and resources that could be used more productively in preparing 
for implementation of HACCP.
    Based on the comments, FSIS has reconsidered its approach to the 
proposed near-term measures. FSIS believes that its regulatory program 
and the food safety efforts of the meat and poultry industry should be 
focused on making a transition to HACCP as rapidly and effectively as 
possible and that FSIS should not mandate any near-term measures that 
would not be expected to continue as mandatory elements of a HACCP-
based system.
    FSIS has decided to adopt final rules that mandate Sanitation 
SOP's. Good sanitation is a critical foundation for HACCP, and 
Sanitation SOP's are an essential element of the FSIS effort to more 
clearly define establishment and inspector responsibilities, and better 
focus both the establishment management and FSIS on those elements of 
daily sanitation that relate most directly to the risk of product 
contamination. Near-term implementation of Sanitation SOP's will 
facilitate the transition to HACCP.
    FSIS has decided not to mandate antimicrobial treatments in 
slaughter establishments. The Agency expects that antimicrobial 
treatments will play an important role in the design of slaughter HACCP 
plans as establishments institute controls that are effective in 
reducing pathogens and meeting FSIS performance standards. As a general 
matter, however, FSIS does not intend to mandate the specific controls 
that establishments must adopt in their HACCP plans. In the case of 
antimicrobial treatments, FSIS believes that improvement in food safety 
would be better served by providing establishments the incentive and 
flexibility to incorporate antimicrobial treatments in any manner they 
judge most effective for their operations to meet FSIS-established 
performance standards for reducing bacterial contamination.
    With respect to carcass cooling, FSIS continues to believe that, in 
a HACCP environment, appropriate performance standards are needed for 
the cooling of carcasses and raw meat and poultry products to prevent 
the growth of harmful bacteria. After consideration of the comments, 
FSIS has concluded, however, that the specific time-and-temperature 
combinations proposed by FSIS were too restrictive and that a 
scientifically sound and effective strategy for preventing the growth 
of pathogens through proper cooling must apply not only within, but 
also beyond, FSIS-inspected establishments. Thus, instead of including 
requirements for carcass cooling in this final rule, FSIS intends to 
extend this rulemaking to consider alternative approaches to 
performance standards for cooling within establishments. Concurrently, 
FSIS also intends to develop rulemaking covering the adoption of 
standards for cooling of raw products during transportation, storage, 
and retail, restaurant or food service sale. FSIS anticipates adopting 
performance standards designed to minimize the growth of harmful 
bacteria on raw products that establishments will be required to meet 
through their HACCP plans. FSIS will announce in a future issue of the 
Federal Register a three-day public conference to gather further 
scientific information and public comment on these subjects.

Timetable for Implementation

Federally Inspected Establishments
    FSIS proposed an implementation timetable that would have phased in 
the near-term measures and HACCP over a period of time beginning 90 
days and ending three years after publication of the final rule. 
Sanitation SOP's and the other near-term measures, as well as the 
proposed microbial sampling by establishments for Salmonella, were to 
begin 90 days after publication. Slaughter establishments were to be 
held accountable for meeting the Salmonella targets two years after 
publication.
    FSIS proposed to phase in HACCP over a one to three-year period, 
primarily on a process-by-process basis. For example, raw ground 
products would be subject to the HACCP requirements one year after 
publication of the final rule, while all slaughter establishments would 
be required to start HACCP thirty months (2\1/2\ years) after 
publication of the final rule. However, FSIS proposed that 
establishments with annual sales of less than $2.5 million be given 
three years to

[[Page 38813]]

comply with the HACCP requirement, regardless of the processes they 
run.
    Some commenters said the proposed implementation timetable was too 
slow, considering the seriousness of the food safety issues involved 
and the familiarity with HACCP that already exists among many in the 
industry. Other commenters pointed out that many larger establishments 
have already adopted HACCP. Some said the Pathogen Reduction/HACCP 
proposal placed excessive burdens on smaller establishments, which were 
said to be less prepared technically and financially to carry out 
HACCP. Wide support was voiced for implementing HACCP as promptly as 
practicable, taking into account the diversity of businesses involved 
and the different levels of readiness for HACCP.
    FSIS has considered these comments and has also re-evaluated the 
proposed timetable for implementation of all requirements discussed 
above in light of preparations FSIS will itself have to make to 
implement HACCP, including the training of inspection and other agency 
employees. FSIS believes it is important to bring the meat and poultry 
supply under HACCP-based process control and to implement other 
elements of its food safety strategy as rapidly as possible. It is also 
important to have a timetable that is realistic for implementing this 
fundamental transformation in how FSIS regulates meat and poultry 
establishments. FSIS is modifying the timetable for implementation in a 
way that achieves both goals.
    The Sanitation SOP's requirements will take effect 6 months after 
publication of these final rules, rather than 90 days as originally 
proposed.
    Establishments slaughtering livestock or poultry will be required 
to begin process control verification testing for generic E. coli 6 
months after publication of this final rule.
    FSIS will begin holding slaughter establishments and establishments 
producing raw ground products accountable for achieving Salmonella 
pathogen reduction performance standards at the time they will be 
required to implement HACCP under the phase-in schedule described 
below, rather than the single, two-year delayed effective date 
originally proposed. Beginning approximately three months after 
publication of this final rule, FSIS will initiate its pre-enforcement 
Salmonella testing program. This establishment-by-establishment 
Salmonella prevalence survey will provide critical data on the 
performance of establishments; it will inform establishments of their 
performance, and guide FSIS enforcement testing and compliance 
strategies after establishments are required to meet the Salmonella 
performance standards.
    In response to comments, FSIS is modifying the proposed timetable 
for implementing HACCP from one based primarily on production process 
in an establishment to one based on establishment size. Under this 
approach, the pace at which most of the Nation's meat and poultry 
supply comes under HACCP-based process control will be accelerated. 
Most important, slaughter establishments that account for 75% of the 
annual meat and poultry production in the United States will be 
required to implement HACCP 18 months after publication of these final 
rules, rather than 30 months after publication as originally proposed. 
At the same time, very small establishments (those with fewer than 10 
employees or with annual sales of less than $2.5 million, together 
accounting for less than 2% of meat and poultry production) will be 
provided an additional six months beyond the proposed three years to 
implement HACCP.
    Under this timetable, FSIS gains needed time to develop and 
sequence inspector training and other preparatory activities. Also, 
establishments that carry out multiple processes (such as the so-called 
``combo'' establishments that both slaughter animals and grind raw 
products) will be able to implement HACCP on a more coherent 
establishment-wide basis, rather than on a process-by-process basis. A 
detailed description of the implementation timetable and its rationale 
is provided in section II of this preamble.
State-Inspected Establishments
    Both the FMIA and PPIA direct Federal cooperation with States in 
developing and administering intrastate inspection programs that 
include mandatory antemortem and postmortem inspection, reinspection, 
and sanitation requirements which are ``at least equal to'' Federal 
requirements. Consequently, each State receiving matching Federal funds 
for the administration of its intrastate meat and poultry inspection 
program must implement Pathogen Reduction/HACCP programs that are at 
least equal to provisions set forth in this final rule. FSIS will 
coordinate closely with States that maintain federally supported meat 
and poultry inspection programs to ensure that Pathogen Reduction/HACCP 
is implemented in all intrastate establishments.
Foreign-Inspected Establishments
    In order to export meat or poultry to the United States, foreign 
countries must establish a system of inspection that is equivalent to 
the system in this country. Determinations of equivalency made by U.S. 
reviewers of foreign meat and poultry inspection systems are currently 
based upon (1) the presence or lack of specific regulatory requirements 
and (2) how those requirements are enforced. As Pathogen Reduction/
HACCP regulatory provisions are implemented in the U.S. domestic 
market, foreign countries will concurrently be evaluated to ascertain 
whether their inspection systems provide equivalent regulatory 
provisions with adequate levels of enforcement.

Implementation Conferences

    FSIS plans to convene a three-day HACCP implementation conference 
in Washington, DC, about 60 days after publication of this final rule. 
Similar sessions will follow in various cities around the country.
    The purpose of the implementation conferences is to continue, and 
build upon, the dialogue among interested parties that occurred during 
the six days of public meetings FSIS conducted in September 1995 on the 
proposed rule. FSIS anticipates that the following topics will be 
discussed at the implementation conferences: (1) status of FSIS efforts 
to develop generic model HACCP plans and conduct small establishment 
HACCP demonstration projects; (2) the draft guidance materials 
published as Appendices; (3) the revised HACCP implementation schedule 
and certain technical aspects of the regulations being promulgated in 
this final rule; (4) other implementation issues identified by the 
public; (5) methods to achieve the goal of consistent training for FSIS 
and industry employees; and (6) due process and enforcement issues.
    In addition, FSIS plans to conduct two public conferences on 
technical issues related to E. coli testing. The first conference is 
planned to be held approximately 45 days into the 60-day comment period 
following publication of this rule. The public conference will be led 
by a panel of scientists from FSIS and other government agencies who 
will listen to testimony and review comments received on these 
technical issues and share their observations and opinions. FSIS will 
consider their input as well as all comments received as the basis for 
any necessary technical amendments which will be completed at least 30 
days before the

[[Page 38814]]

implementation date. The second conference is tentatively planned for 
approximately 9 months following publication of this rule. This 
conference would be an opportunity for the industry and others to 
discuss with FSIS new information based on about 3 months of testing 
experience that may bear on these same issues and might allow for 
further adjustments of protocols before FSIS inspectors are tasked, 
about three months later, with comparing test results to the national 
criteria as part of their inspection routine. FSIS will publish 
further, more detailed notice of these conferences in future issues of 
the Federal Register.

Request for Comments

    These final rules have benefitted from substantial public comment 
and the dialogue that took place during extensive public meetings with 
interested groups and individuals. Following the close of the comment 
period on November 13, 1995, several industry associations requested 
that these regulations be issued as ``interim'' final rules with a 30-
day opportunity for further public comment prior to the rules becoming 
final. FSIS is denying this request because the HACCP principles and 
other major elements of these final regulations have already been the 
subject of unusually extensive public comment and dialogue, and it is 
important to proceed toward implementation of these new food safety 
measures as promptly as possible.
    FSIS seeks comments, however, on certain technical aspects of these 
final regulations and on the guidelines (published here as Appendices) 
that will play a role in implementation of sanitation SOP's, microbial 
testing, and HACCP. FSIS requests comments no later than September 23, 
1996 on (1) technical issues that are associated with E. coli testing; 
(2) the E. coli performance criteria, and (3) the Sanitation SOP's 
Guideline and Model Sanitation SOP's, published at Appendices A and B, 
respectively.
    Based on comments it receives, FSIS will make any necessary 
revisions in the draft guidelines and technical aspects of the E. coli 
testing regulation prior to the effective date of the affected 
regulatory requirements.
    With respect to the HACCP final regulations, FSIS requests comments 
by November 22, 1996 on (1) the revised HACCP implementation timetable, 
including any factual information that commenters believe would justify 
any adjustments in the announced effective dates; (2) the Hazards and 
Preventive Measures Guide (published at Appendix D) and (3) the 
Guidebook for the Preparation of HACCP Plans (published at Appendix C).

II. Hazard Analysis and Critical Control Point Systems

Overview of Final Rule

    This final rule requires that federally inspected establishments 
implement HACCP systems to address hazards that are reasonably likely 
to occur in their operations. The HACCP systems mandated by this final 
rule focus on attributes affecting product safety, not those affecting 
economic adulteration or quality. On the effective dates of this final 
rule, FSIS will begin verifying HACCP system operations as part of its 
inspection program. Establishments will be required to maintain a HACCP 
plan covering every meat or poultry product produced for human food. 
Processes for which HACCP plans must be developed include slaughter for 
all species; raw ground meat or poultry products; raw product, not 
ground (e.g., meat cuts or whole or cut-up birds); shelf-stable 
nonheat-treated products (e.g., jerky); shelf-stable heat-treated 
products (e.g., edible fats); thermally processed/commercially sterile 
products (e.g., canned soup); fully cooked nonshelf-stable products 
(e.g., canned hams that must be refrigerated); not fully cooked/heat-
treated products (e.g., char-marked beef patties); and nonshelf-stable 
products with secondary inhibitors (e.g., fermented sausage). It should 
be noted that the category of raw, not ground product can include 
products with certain additional processing steps beyond carcass 
dressing, such as cutting up whole carcasses or marinating meat or 
poultry products.

History and Background of HACCP

    HACCP is a conceptually simple system whereby meat and poultry 
establishments can identify and evaluate the food safety hazards that 
can affect the safety of their products, institute controls necessary 
to prevent those hazards from occurring or keeping them within 
acceptable limits, monitor the performance of controls, and maintain 
records routinely. HACCP is the best system currently available for 
maximizing the safety of the nation's food supply.
    HACCP systems have been recommended for use in the food industry 
for more than a quarter century. The HACCP concept has been promoted by 
government and scientific groups and incorporated for many years in 
FSIS's and FDA's regulations on canned foods. Committees of the NAS 
have recommended that government agencies with responsibility for 
controlling microbiological hazards in foods, including FSIS, 
promulgate regulations requiring industry to utilize the HACCP system 
for food protection purposes.
    The NACMCF, which was established in accordance with a NAS 
committee recommendation, endorsed the HACCP system as an effective and 
rational approach to the assurance of food safety. In its March 20, 
1992, publication ``Hazard Analysis and Critical Control Point 
System,'' NACMCF advocated the standardization of the HACCP principles 
and their application by industry and regulatory authorities, with each 
food-producing establishment developing a HACCP system tailored to its 
individual product, processing, and distribution conditions.
    The U.S. General Accounting Office, in a series of reports between 
1992 and 1994, endorsed HACCP as an effective, scientific, risk-based 
system for protecting the public from foodborne illness. On December 
18, 1995, the FDA published final rules requiring the adoption of HACCP 
systems in seafood processing plants (60 FR 65096).
    International and foreign government bodies have also advocated the 
adoption of HACCP systems. The International Commission on 
Microbiological Specifications for Foods (ICMSF), in its 1988 report, 
``HACCP in Microbiological Safety and Quality,'' endorsed the use of 
HACCP systems in food production, processing, and handling. In 1993, 
the Food and Agriculture Organization/World Health Organization Codex 
Alimentarius Commission adopted a HACCP document that now serves as a 
guide for countries to incorporate HACCP principles into their food 
industries. The seven HACCP principles adopted by the Codex 
Alimentarius Commission are identical to those adopted by the NACMCF 
and on which this final rule is based. HACCP principles have been 
embodied in recent European Union regulatory directives and in food 
protection programs conducted by the governments of Canada, New 
Zealand, and Australia.

The Seven HACCP Principles

    The seven HACCP principles recommended by NACMCF in 1992 provide 
the framework for this final rule. While the seven principles are not 
explicitly listed as such in the codified regulatory text, they are 
embodied in the regulatory requirements for a hazard analysis in 
Sec. 417.2(a); the elements of a HACCP plan in Sec. 417.2 (b) and (c); 
the corrective action requirements in Sec. 417.3; the validation, 
verification, and reassessment requirements in Sec. 417.4; and the 
record review and maintenance

[[Page 38815]]

requirements in Sec. 417.5. The seven HACCP principles are discussed 
below.
    Principle No. 1: A hazard analysis of each process must be carried 
out. The purpose of the analysis is to identify and list the food 
safety hazards reasonably likely to occur in the production process for 
a particular product and the preventive measures necessary to control 
the hazards. A food safety hazard is any biological, chemical, or 
physical property that may cause a food to be adulterated or otherwise 
unsafe for human consumption. A listed hazard must be of such a nature 
that its prevention, elimination, or reduction to acceptable levels is 
essential to the production of a safe food.
    Examples of questions to be considered in a hazard analysis 
include: (1) What potential hazards may be present in the animals to be 
slaughtered or the raw materials to be processed? (2) What are the 
avenues that might lead to contamination of finished product with 
pathogenic microorganisms, hazardous chemicals, or other potentially 
hazardous contaminants? (3) What is the likelihood of such 
contamination and what are the means for preventing it? (4) Does the 
food contain any ingredient historically associated with a known 
microbiological hazard? (5) Does the food permit survival or 
multiplication of pathogens or toxin formation during processing? (6) 
Does the process include a controllable processing step that destroys 
pathogens? (7) Is it likely that the food will contain pathogens and 
are they likely to increase during the times and conditions under which 
the food is normally stored before being consumed? (8) What product 
safety devices are used to enhance consumer safety (e.g., metal 
detectors, filters, thermocouples)? (9) Does the method of packaging 
affect the multiplication of pathogenic microorganisms and/or the 
formation of toxins? (10) Is the product epidemiologically linked to a 
foodborne disease?
    Principle No. 2: The critical control points (CCP) of each process 
must be identified. A CCP is a point, step, or procedure at which 
control can be applied and a food safety hazard can be prevented, 
eliminated, or reduced to an acceptable level. All hazards identified 
during the hazard analysis must be addressed. The information developed 
during the hazard analysis should enable the establishment to identify 
which steps in their processes are CCP's.
    Identification of CCP's for controlling microbial hazards 
throughout the production process is particularly important because 
these hazards are the primary cause of foodborne illness. The 
establishment may find the CCP decision tree developed by the NACMCF 
useful in the CCP identification process (see Figure 1). However, the 
use of this technique in identifying CCP's is not required by this 
final rule.
    Principle No. 3: The critical limits for preventive measures 
associated with each identified CCP must be established.

BILLING CODE 3410-DM-P

[[Page 38816]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.000



BILLING CODE 3410-DM-C
A critical limit is the maximum or minimum value to which a process 
parameter must be controlled at a CCP to prevent, eliminate, or reduce 
to an acceptable level the identified physical, biological, or chemical 
food safety hazard. Critical limits are most often based on process 
parameters such as temperature, time, physical dimensions, humidity, 
moisture level, water activity, pH, titratable acidity, salt 
concentration, available chlorine, viscosity, preservatives, or 
survival of target pathogens. Critical limits should be based on 
applicable FSIS regulations or guidelines, FDA tolerances and action 
levels, scientific and technical literature, surveys, experimental 
studies, or the recommendations of recognized experts in the industry, 
academia, or trade associations.
    Establishments are encouraged to establish critical limits more 
stringent than those now required by FSIS regulations or suggested by 
scientific data to ensure that regulatory requirements are routinely 
met, even when minor deviations occur.
    Principle No. 4: The monitoring requirements for CCP's must be 
established. Monitoring is an integral part of HACCP and consists of 
observations or measurements taken to assess whether a CCP is within 
the established critical limit. Continuous monitoring is preferred, but 
when it is not feasible, monitoring frequencies must be sufficient to 
ensure that the CCP is under control.
    Assignment of the responsibility for monitoring is an important 
consideration for each CCP. Personnel assigned the monitoring 
activities should be properly trained to accurately record all results, 
including any deviations, so that immediate corrective actions may be 
taken.
    Principle No. 5: The HACCP plan must include corrective action to 
be taken when monitoring indicates that there is a deviation from a 
critical limit at a critical control point. Although the process of 
developing a HACCP plan emphasizes organized and preventive thinking 
about what is occurring as the meat or poultry product is being 
manufactured, the existence of a HACCP plan does not guarantee that 
problems will not arise. For this reason, the identification of a 
planned set of activities to address deviations is an important part of 
a HACCP plan. In such instances, corrective action plans must be in 
place to determine the disposition of the potentially unsafe or 
noncompliant product and to identify and correct the cause of the 
deviation. The HACCP plan itself might require modification, perhaps in 
the form of a new critical limit, or of an additional CCP.

[[Page 38817]]

    Principle No. 6: Effective recordkeeping procedures that document 
the entire HACCP system must be developed and maintained. A HACCP 
system will not work unless consistent, reliable records are generated 
during the operation of the plan, and those records are maintained and 
available for review. One of the principal benefits of a HACCP process 
control system to both industry and regulatory officials is the 
availability of objective, relevant data.
    Principle No. 7: HACCP systems must be systematically verified. 
After initial validation that the HACCP system can work correctly and 
effectively with respect to the hazards, the system must be verified 
periodically. Periodic verification involves the use of methods, 
procedures, or tests in addition to those used for monitoring, to 
determine whether the HACCP system is in compliance with the HACCP plan 
and/or whether the HACCP plan needs modification and revalidation to 
achieve its food safety objective.
    In the NACMCF explanation of the verification principle, which FSIS 
is following, four processes are involved in the verification of the 
establishment's HACCP system. The establishment is responsible for the 
first three; FSIS is responsible for the fourth. The first is the 
scientific and technical process, known as ``validation,'' for 
determining that the CCP's and associated critical limits are adequate 
and sufficient to control likely hazards. The second process is to 
ensure, initially and on an ongoing basis, that the entire HACCP system 
functions properly. The third consists of documented, periodic, 
reassessment of the HACCP plan. The fourth process defines FSIS's 
responsibility for certain actions (Government verification) to ensure 
that the establishment's HACCP system is functioning adequately.

HACCP and the FSIS Food Safety Strategy

    The food safety goal of FSIS's Pathogen Reduction/HACCP rulemaking 
proposal is to reduce the risk of foodborne illness from meat and 
poultry products to the maximum extent possible by ensuring that 
appropriate and feasible preventive and corrective measures are taken 
at each stage of the food production process where food safety hazards 
occur. There is no single technological or regulatory solution to the 
problem of foodborne illness. Continuous efforts are required by 
industry and government to improve methods for identifying and 
preventing hazards and to minimize the risk of illness.
    FSIS proposed HACCP as the framework for carrying out its 
comprehensive strategy to improve food safety. HACCP, combined with the 
other measures required by this rulemaking, will substantially improve 
the ability of meat and poultry establishments and FSIS to target and 
systematically prevent and reduce food safety hazards and, working 
together, to continuously improve food safety as science and technology 
improve. These measures fill a critical gap in the current system with 
respect to the control and reduction of harmful bacteria on raw meat 
and poultry products and will, over time, significantly reduce the risk 
of foodborne illness.
    FSIS's meat and poultry inspection program currently addresses and 
will continue to address many matters of importance to the safety and 
quality of the food supply, including supervision of industry 
compliance with sanitation standards, exclusion of diseased animals 
from the food supply, examination of carcasses for other visible 
defects that can affect safety and quality, and inspecting for economic 
adulteration. These activities respond to some of the public's most 
basic expectations regarding the safety and quality of the food supply 
and reflect the standards and requirements established by Congress in 
the laws FSIS administers. FSIS is strongly committed to the most 
effective and efficient implementation of these statutory requirements.
    This final rule initiates a fundamental change in the inspection 
program to better meet FSIS's paramount obligation to protect the 
public health. Specifically, it addresses in a substantive way the 
public health problem of foodborne illness associated with the 
consumption of meat and poultry products. It does so in large part by 
better delineating and clarifying the respective roles of industry and 
FSIS to ensure that meat and poultry products are produced in 
accordance with sanitation and safety standards and are not adulterated 
or misbranded within the meaning of the FMIA and PPIA. This rule makes 
clear that the industry is responsible for producing and marketing 
products that are safe, unadulterated, and properly labeled and 
packaged. FSIS is responsible for inspecting products and facilities to 
verify that the statutory requirements are being met and for taking 
appropriate compliance and enforcement actions when the requirements 
are not being met.
    The line between the responsibilities of FSIS and those of the 
industry has often been blurred. This is because of the prescriptive 
nature of the current FSIS inspection program and the tendency for some 
establishments to rely on FSIS inspectors to do what is necessary to 
direct the correction of deficiencies and to ensure that outgoing 
products are safe, and not adulterated or misbranded. Some 
establishments operate on the assumption that if the inspector 
identifies no problem, their meat or poultry products may be entered 
into commerce. This is even more problematic because the current 
inspection system is based primarily on organoleptic methods that 
cannot detect the hazards of pathogenic microorganisms. The line has 
also been blurred because of the excessive reliance of the FSIS 
inspection program on the detection and correction of problems after 
the fact, rather than assurance that problems will be prevented, 
systematically by design, in the first place.
    The changes FSIS will effect with this final rule will eliminate 
this confusion and delineate clearly the respective responsibilities of 
FSIS and industry. The changes constitute a fundamental shift in the 
FSIS regulatory program, which FSIS is convinced will significantly 
enhance the effectiveness of the program and substantially reduce the 
risk of foodborne illness.

Preparing for HACCP Implementation

    For the new FSIS food safety strategy, particularly HACCP, to be 
successful, FSIS must reconsider its current reliance on prescriptive 
command-and-control regulations and instead rely more on performance 
standards. Not only do command-and-control regulations prescribe the 
means by which establishments are to achieve a particular food safety 
objective, but they are susceptible of being enforced in a manner that 
leads to the inspector's substantial involvement in management 
decisionmaking. Performance standards, on the other hand, prescribe the 
objectives or levels of performance (such as pathogen reduction 
standards for raw product) establishments must achieve, but afford 
establishments flexibility in determining how to achieve those 
performance objectives. The shift to performance standards and the 
concomitant increase in flexibility for meat and poultry establishments 
reflect FSIS's commitment to stimulating the innovative capacity of the 
meat and poultry and allied industries to improve the safety of their 
products.
    Command-and-control regulations are generally incompatible with 
HACCP and the FSIS food safety strategy, and conflict with the goal of 
reducing the

[[Page 38818]]

risk of foodborne illness on a continuing basis. They deprive 
establishments of the flexibility to innovate, one of the primary 
advantages of HACCP, and undercut the clear delineation of food safety 
responsibilities between industry and FSIS, on which the FSIS strategy 
is based. Therefore, to prepare for HACCP implementation, FSIS is 
conducting a thorough review of its current regulations and will, to 
the maximum extent possible, convert its command-and-control 
regulations to performance standards. (For a discussion of this 
regulatory reform initiative, see advance notice of proposed rulemaking 
published on December 29, 1995; Docket No. 95-008A; 60 FR 67469).

Inspection Under HACCP

    HACCP-oriented food safety inspection changes FSIS's approach to 
overseeing the safety of meat and poultry products. Under this new 
approach, FSIS will rely less on after-the-fact detection of product 
and process defects and more on verifying the effectiveness of 
processes and process controls designed to ensure food safety. FSIS 
will restructure its inspection tasks and rely on review techniques 
aimed at systems designed for preventing problems that could lead to 
the production of unsafe meat or poultry products. FSIS will carry out 
various activities to ensure that industry HACCP systems meet the 
requirements of this rule, and are functioning as designed.
    Beginning on the effective date of the regulation for a particular 
establishment, FSIS personnel will carry out a general review of an 
establishment's HACCP plan to determine its conformance with the seven 
HACCP principles. This evaluation will take place at the time of start-
up or initial implementation of the HACCP plan for new establishments. 
Subsequently, special teams of FSIS personnel will work in conjunction 
with assigned inspectors to conduct in-depth reviews, on a regular 
basis, of the establishment's current HACCP plan to verify their 
scientific validity and ongoing adequacy for preventing food safety 
hazards. Further, at any time that the HACCP plan is revised or 
amended, FSIS personnel assigned to the establishment will review the 
plan to determine if it is in conformance with regulatory requirements.
    FSIS will also carry out its verification activities by focusing on 
an establishment's ongoing compliance with HACCP-related requirements. 
Inspectors will be assigned to carry out the verification activities 
under HACCP-oriented inspection in much the same way as they receive 
their assignment schedules under the current system. A verification 
activity might include reviewing all establishment monitoring records 
for a process, reviewing establishment records for a production lot, 
direct observation of CCP controls as conducted by establishment 
employees, collecting samples for FSIS laboratory analysis, or 
verifying establishment verification activities for a process.
    As HACCP-based process control is established in meat and poultry 
establishments, with its continuous monitoring by the establishment and 
oversight by FSIS, opportunities to incorporate new technologies and 
continuously improve food safety will be more readily identified. The 
continuous monitoring and verification of production processes and 
controls by the establishment and FSIS, which is an essential feature 
of the HACCP system, will set the stage for further food safety 
improvements.
    Many commenters on the proposal expressed concern that the number 
of inspectors would decline and the quality of Federal inspection would 
diminish with HACCP implementation. FSIS expects HACCP to enhance the 
effectiveness of its meat and poultry inspection, not diminish it. 
Implementation of this final rule will clarify that the meat and 
poultry industries and FSIS have separate responsibilities for safety 
of the food supply. Industry will be required to establish process 
control systems for all forms of meat and poultry slaughter and 
processing and meet appropriate regulatory performance standards. By 
vigorous inspectional oversight of HACCP and reliance on objective test 
results and other observations to verify compliance with performance 
standards, FSIS inspectors will be better able to ensure that products 
leaving FSIS establishments are safe. Also, FSIS will be better able to 
allocate its resources to areas of greatest risk. HACCP implementation 
will move both industry and FSIS toward a more preventive approach to 
ensuring the safety of meat and poultry.
    A cross-section of consumer groups, FSIS employees, and meat and 
poultry establishments stated that each livestock and bird carcass must 
continue to be examined by trained, experienced FSIS inspectors and 
veterinarians, even under a HACCP system. They stated that carcass-by-
carcass inspection is essential to identifying animals with diseases 
that are transmissible to humans and other disease conditions causing 
animals to be unacceptable for human food. About 2,000 commenters 
maintained that HACCP is not, nor should it be, a substitute for 
carcass-by-carcass inspection by Federal inspectors.
    Carcass-by-carcass inspection is a legal requirement that binds 
both FSIS and the industry. It also addresses nonsafety considerations 
that are not addressed by HACCP. Therefore, HACCP cannot substitute for 
carcass-by-carcass examination. However, in light of HACCP, which will 
improve process control in slaughter establishments, FSIS plans to 
examine current tasks related to carcass-by-carcass inspection and 
determine what changes, if any, could improve the effectiveness of 
inspection or result in a more productive use of resources.
    Many commenters representing the meat and poultry industries argued 
that proposed pathogen reduction and HACCP system requirements layer an 
additional set of regulations and an additional program of inspection 
onto the current meat and poultry inspection system. These commenters 
recommended that FSIS review and revise or eliminate current 
regulations, directives and other FSIS guidance prior to finalizing the 
proposal as a means for ensuring they are compatible with pathogen 
reduction and HACCP requirements. Commenters stated that this review 
would not only mitigate inspection burdens imposed on industry by the 
proposal, but would facilitate the smooth implementation of pathogen 
reduction and HACCP requirements, as well.
    FSIS agrees that regulations, directives, and guidelines should be 
consistent with HACCP and is currently reviewing regulations, 
directives, and other guidance materials governing meat and poultry 
inspection. Those regulations, directives, and guidance documents that 
are inconsistent or incompatible with HACCP principles and procedures 
will be amended or revoked. This task will not only ensure consistency 
throughout the regulations, directives, and other documents, but will 
reduce duplication and help focus inspection on the most serious risks 
to food safety.

Implementation Schedule

    FSIS proposed to phase in implementation of HACCP during a 12 to 
36-month period primarily on a process-by-process basis, except that 
all ``small'' establishments (defined as establishments with annual 
sales of less than $2.5 million) would be allowed the full 36 months to 
implement their HACCP plans.
    FSIS received numerous comments on the proposed implementation 
schedule. Many commenters from meat and

[[Page 38819]]

poultry establishments said the proposed period for implementing HACCP 
was too short. These commenters requested more time to develop HACCP 
plans, train employees, and purchase or upgrade equipment. Many 
commenters requested that small businesses be granted more time to 
implement HACCP so they could amortize the costs of hazard analysis and 
plan development, equipment purchases, personnel training and records 
maintenance. A number of commenters suggested alternative timetables 
for implementation, ranging from three to fifteen years.
    Several consumer groups argued that the proposed implementation 
schedule was too slow and would compromise public health because 
serious outbreaks of foodborne illness would continue to occur while 
establishments prepare for HACCP implementation. Some industry 
commenters said they were ready to implement HACCP immediately and 
expressed concern about whether and when the FSIS inspection force 
would be prepared to oversee HACCP implementation.
    Also, several commenters requested a tiered implementation based on 
product risk. These commenters suggested that establishments which 
produce high-risk products, such as slaughter establishments or ground 
beef processors, be required to implement HACCP first and that 
establishments which produce low-risk products, such as canning 
establishments, be required to implement HACCP last.
    Also, some commenters were concerned about the proposed phase-in 
period based on different types of product categories and processes 
because contaminated meat and poultry are known to come from a variety 
of sources. Commenters said that requiring establishments to implement 
HACCP at different times for different processes within an 
establishment would confuse establishment employees, inspection 
personnel and consumers. Consequently, these commenters suggested that 
HACCP be implemented simultaneously by all establishments.
    Other commenters disputed the definition of small business used in 
the proposal. Recommendations for defining a small business included 
using fewer-than-500-employees definition developed by the Small 
Business Administration (SBA), using a definition reflecting volume of 
product or number of animals slaughtered, or using a definition based 
on the level of sales.
    In response to concerns expressed by commenters, FSIS is modifying 
the implementation schedule for HACCP. The revised implementation 
schedule is based on the size of an establishment, that is, a business 
entity producing meat or poultry products at a location. Each 
establishment is required to implement HACCP simultaneously for all 
processes, rather than on a process-by- process basis. Large 
establishments (those having 500 or more employees) are required to 
implement HACCP 18 months after publication of this final rule. 
``Small'' establishments are required to implement HACCP 30 months 
after publication. The definition of ``small'' establishment has been 
changed to correspond with SBA's size standards for business entities, 
and is now an establishment having 10 or more but fewer than 500 
employees. A new category of ``very small'' establishments (those 
having fewer than 10 employees or less than $2.5 million in annual 
sales) will have 42 months to implement HACCP. All individuals employed 
on a full-time, part-time, temporary, or other basis at a given 
establishment must be counted as employees. This requirement 
corresponds with the SBA definition of employee set forth in 13 CFR 
121.404.
    FSIS is committed to bringing the Nation's meat and poultry supply 
under HACCP systems as rapidly as possible. Phasing in HACCP 
implementation is essential due to the logistical effort required to 
manage a fundamental change in work processes, roles, and 
responsibilities for both establishments and FSIS. The revised 
implementation schedule reflects the readiness of establishments of 
varying sizes to implement HACCP, the time needed by industry to 
develop HACCP plans and train employees, and the time needed by FSIS to 
train its employees.
    The principal advantages of the revised implementation schedule are 
as follows:
    1. Large slaughter establishments account for 75 percent of 
slaughter production and thus, most of the Nation's meat and poultry 
supply will come under HACCP-based process control one year earlier 
than originally proposed. Because the greatest risk of contamination 
with pathogenic microorganisms occurs during this initial stage of 
production, FSIS considers this a significant improvement over the 
original schedule in terms of expediting progress on improving the 
safety of meat and poultry products. The revised implementation 
schedule also ensures that approximately 45 percent of processed 
products will be produced under a HACCP system within 18 months. In 
comparison, only 25 percent of processed products would have been 
produced under HACCP systems at the 18-month mark based on the proposed 
implementation schedule.
    2. By shifting initial implementation of HACCP from 12 months to 18 
months after publication of the final rule, FSIS will have sufficient 
time to manage the transition to sanitation SOP's in all 
establishments, which will begin six months after publication of this 
final rule, and to train FSIS employees to implement HACCP. FSIS does 
not believe it could manage this transition and successfully implement 
HACCP in 12 months.
    3. Eighteen months will provide ample time for the large 
establishments to comply. In fact, it is reasonable to assume that many 
of these establishments may implement HACCP before the deadline.
    4. Implementing HACCP on the basis of establishment size will be 
simpler for both FSIS and establishments and much less disruptive for 
establishments with multiple processes. Under the proposal, these 
establishments would have faced multiple implementation dates (e.g., 
establishments that both slaughter cattle and grind beef).
    5. The ``very small'' establishments will have an additional six 
months to implement HACCP. This will enable FSIS to complete the 
demonstration projects planned for ``small'' and ``very small'' 
establishments. The extra time will also ensure the availability of 
``off-the-shelf'' HACCP training programs prepared by private or 
industry-sponsored consultants. Other FSIS implementation aids, such as 
model HACCP plans, audio, video, or computer training aids, and various 
publications such as guidelines, notices and pamphlets will have 
undergone extensive development as well.

Small Business Issues

    FSIS recognizes that many smaller establishments lack the 
familiarity with HACCP that exists already in many larger 
establishments. Therefore, FSIS is planning an array of assistance 
activities that will facilitate implementation of HACCP in ``small'' 
and ``very small'' establishments.
    FSIS is developing 13 generic HACCP models for the major process 
categories, which will be available in draft form for public comment, 
and in final form, at least six months before HACCP implementation. The 
generic models are being developed especially to assist ``small'' and 
``very small'' establishments in preparing their HACCP plans. Because 
each HACCP system is developed by an individual establishment for its 
specific process and practices, the generic models will serve only as 
illustrations, rather than as

[[Page 38820]]

prescriptive blueprints for a specific HACCP plan. They should, 
however, remove much of the guesswork and reduce the costs associated 
with developing HACCP plans.
    FSIS will also conduct HACCP demonstration projects for ``small'' 
and ``very small'' establishments during the two-year period following 
promulgation of this final rule. These projects will be conducted at 
various sites to show how HACCP systems can work for various products 
under actual operating conditions. Some of these demonstrations will 
involve ``very small'' establishments and will address issues unique to 
those establishments. For instance, how does a HACCP system function in 
an establishment with only a single employee? Through these 
demonstration projects, FSIS, State inspection authorities, 
participating establishments, and the industry at large will gain added 
understanding of the problems and techniques of HACCP implementation 
and operation in ``small'' and ``very small'' establishments.
    FSIS is making available to ``small'' and ``very small'' 
establishments various HACCP materials that should assist these 
establishments in conducting their hazard analyses and developing their 
HACCP plans. These guidance materials include a ``Guidebook for the 
Preparation of HACCP Plans'' (Appendix C) and a ``Hazards and 
Preventive Measures Guide'' (Appendix D). These materials should be 
particularly useful to ``small'' and ``very small'' establishments that 
may lack the expertise for conducting hazard analyses and designing 
establishment-specific HACCP plans.
    The ``Guidebook for the Preparation of HACCP Plans'' has been 
designed to provide ``small'' and ``very small'' establishments with a 
step-by-step approach for developing a HACCP plan and includes examples 
and sample forms at each step. The Guidebook can be used alone or in 
combination with the ``Hazards and Preventive Measures Guide.''
    Because the development of an adequate HACCP plan depends on a good 
hazard analysis, the ``Hazards and Preventive Measures Guide'' develops 
HACCP Principle No. 1 in much greater detail than does the ``Guidebook 
for the Preparation of HACCP Plans.'' The hazards guide identifies 
potential biological, chemical, and physical hazards associated with a 
variety of raw materials and common ingredients, as well as major 
processes used in the meat and poultry industry. In addition, the 
hazards guide contains examples of preventive measures for common 
hazards and associated critical limits for those measures. Also 
provided are examples to illustrate approaches to implementing the 
remaining HACCP principles (e.g., monitoring, corrective actions, 
records, and verification procedures) for various hazards and critical 
control points.
    FSIS invites comments and suggestions on how it may further ease 
the transition of ``small'' and ``very small'' establishments to HACCP-
based operations.

Training Considerations

    Many commenters, including consumer groups, FSIS employees, meat 
and poultry establishments, and State governments, agreed that proper 
training in HACCP procedures and plan development is vital for 
successful HACCP implementation. A number of commenters suggested that 
joint training sessions be held for FSIS and establishment employees to 
ensure uniform understanding between inspection personnel and industry. 
Others suggested that FSIS certify acceptable training sites and 
courses of study for establishment employees to coincide with 
government employee training. However, some commenters argued that FSIS 
should not accredit training programs because to do so would limit the 
development of training programs.
    FSIS agrees that effective training of both FSIS and industry 
employees is critical to HACCP's success. FSIS also agrees that 
alternatives are needed to make training practical for various kinds of 
establishments. With these objectives in mind, FSIS is cooperating with 
the private sector to ensure that a wide variety of training options 
are available to industry and FSIS employees. For instance, FSIS is 
encouraging the International Meat and Poultry HACCP Alliance, national 
and local trade associations, State and local officials, the State 
agricultural extension services, and local colleges and universities to 
help establishments incorporate HACCP into their operations. The 
implementation conferences, discussed elsewhere in this preamble, will 
address how to achieve the goal of consistent training for FSIS and 
industry employees.
    Other plans include offering HACCP briefings to industry at many 
locations nationwide. Each session will be led by FSIS HACCP trainers, 
will be held during the evening, be open to industry and other 
interested persons, and include a question-and-answer period. FSIS 
training sessions will be limited to FSIS and State employees because 
of complex logistical and cost considerations.
    USDA's National Agricultural Library has developed and maintains 
the HACCP Training Programs and Resources Database. It is accessible 
via the Internet at ``http://www.nalusda.gov/fnic/foodborne/
foodborn.htm'' or ``gopher://gopher.nalusda.gov/11/infocntr/fnic/
foodborne/haccp'' and provides listings of available training programs 
(workshops, satellite conferences, etc.), resources (videotapes, 
software, manuals, textbooks, etc.), and consultants (individuals and 
companies). Other Internet servers with HACCP-related information are 
operated by various firms, governments, organizations, and academic 
institutions.
    Several meat and poultry establishments also commented on funding 
for HACCP training, suggesting that FSIS or State inspection programs 
fund establishment employee HACCP training. FSIS is making every effort 
to assist establishments in making the transition to HACCP. However, 
each establishment will be responsible for training its employees.

Mandatory Versus Voluntary HACCP

    Most commenters supported the FSIS proposal to make HACCP mandatory 
in all meat and poultry establishments. However, some commenters 
requested that HACCP be voluntary rather than mandatory to alleviate 
economic burdens, especially on small businesses. Commenters further 
suggested that, at such time as a voluntary HACCP program proved 
successful, FSIS could mandate HACCP or, alternatively, market forces 
and advancing technology could be relied on to ensure its broad 
acceptance in all parts of the meat and poultry industry.
    FSIS has determined that a mandatory HACCP program is the only 
viable option that will effect adequate processing improvements in all 
establishments throughout the meat and poultry industries. Mandatory 
HACCP systems are supported by several prominent organizations, 
including the International Meat and Poultry HACCP Alliance and the 
American Meat Institute, which petitioned FSIS to initiate rulemaking 
to mandate HACCP. HACCP is now and has been voluntary; some 
establishments have it, most do not. The preamble to the proposed rule 
explained FSIS's conclusion, affirmed by most commenters, that HACCP is 
the optimal framework for targeting and reducing the many potential, 
but largely preventable, hazards associated with meat and poultry 
products. The risks of

[[Page 38821]]

foodborne illness associated with meat and poultry products will be 
minimized to the greatest extent possible only if HACCP systems are 
implemented in every establishment.

HACCP From Farm-to-Table

    A large number of commenters requested that HACCP be required 
throughout all phases of food production, from the farm to the 
consumer. These commenters asserted that HACCP plans could be developed 
by producers, slaughterers, processors, retailers, food service 
operators, and restaurants to assess and mitigate food safety risks. 
Furthermore, many commenters claimed that the majority of foodborne 
illness cases can be attributed to mishandling at the consumer level 
and FSIS should therefore strengthen consumer education as well as 
require HACCP.
    There is widespread agreement that ensuring food safety requires 
taking steps throughout the farm-to-consumer continuum to prevent 
hazards and reduce the risk of foodborne illness. FSIS is encouraging 
the active development of food safety measures to minimize public 
health hazards in animals presented for slaughter. A description of 
these farm-to-table efforts is discussed earlier in this document.

Total Quality Control (TQC) Establishments and HACCP

    One commenter requested that establishments currently operating 
under the TQC provisions (9 CFR 318.4(c) and, 381.145(c)) be allowed to 
continue to operate under modified hours. If this is not the case, 
establishments currently under TQC will incur considerable overtime 
costs. The commenter asked why, if HACCP represents an improvement over 
TQC, the establishment operating under HACCP should require more 
inspection coverage than one operating under current TQC provisions.
    This final rule does not alter current policies and practices 
regarding inspectional coverage and overtime charges in establishments 
operating under FSIS-approved TQC systems. HACCP is a safety-oriented 
system of process control that addresses food safety hazards 
differently than any current FSIS inspection systems, including TQC. 
Because TQC systems address considerations unrelated to safety, 
inspection practices developed by FSIS in connection with TQC may or 
may not be applicable to the implementation of HACCP.

Freedom of Information Act Concerns

    Most commenters stated that HACCP records should not be available 
to requestors through the Freedom of Information Act (FOIA). Some said 
HACCP records should be used for verification only and should not be 
included in government files. Others also suggested that access to 
records by FSIS inspection personnel be restricted to records that are 
necessary for HACCP compliance monitoring, such as hazard analyses, 
HACCP plans, CCP monitoring records and corrective action 
documentation. Other commenters wanted to prohibit FSIS personnel from 
copying or removing any records from the establishment. Some commenters 
requested that HACCP records be generally available to the public.
    In the preamble to the proposed regulation, FSIS stated that, as a 
preliminary matter, at least some elements of HACCP plans and 
monitoring records could be classified as trade secrets or commercial 
confidential information and may be protected from public disclosure 
under exemptions provided by FOIA and USDA and FSIS regulations 
promulgated pursuant to FOIA. FSIS specifically invited comment on the 
issue of public disclosure of HACCP records and on whether FSIS has any 
discretion about the releasability of HACCP records that it has in its 
possession.
    Recordkeeping is critical to the successful functioning of HACCP 
systems in meat and poultry establishments. FSIS will have access to 
HACCP records and any other records FSIS regulations require. While the 
records required by this final rule are clearly within the 
establishment's domain and ownership, FSIS will have access to them. 
These records, and FSIS access to them, are necessary to effectuate a 
mandatory system of preventive controls to achieve food safety.
    FSIS will continue to make use of documentation to which it has 
access when necessary to evaluate the operations of official 
establishments. Inspection personnel will normally review the records 
at establishments as part of routine HACCP oversight activities. When 
inspection personnel suspect that an establishment's HACCP system is 
not operating correctly, they will copy appropriate portions of 
establishment records, as needed, for further evaluation and possible 
enforcement action.
    An establishment will not ordinarily be required to submit copies 
of HACCP plans, verification documents, or day-to-day operating records 
to FSIS. Consequently, FSIS will not normally possess establishment 
records that may be of a proprietary nature and the issue of whether 
they are releasable under FOIA should not arise.
    Copies of establishment HACCP records may, however, be acquired by 
inspection personnel to document enforcement actions or otherwise 
assist FSIS in carrying out its responsibilities. The release by FSIS 
of information about establishments and their operations is governed by 
the FOIA. This statute requires Federal agencies to make available to 
the public agency rules, opinions, orders, records, proceedings, and 
information concerning agency organization and operations. FOIA 
provides exemptions from public disclosure for various kinds of 
information, including information concerning trade secrets and 
confidential commercial or financial information, and information 
compiled for law enforcement purposes, the release of which would be 
prejudicial or harmful to law enforcement or to the privacy rights or 
safety of individuals.
    The FOIA disclosure exemption that is most likely to be relevant is 
that covering trade secret and confidential, commercially valuable 
information. FSIS's experience in meat and poultry inspection, its 
experience with HACCP, and its understanding from the cost-benefit 
modeling and other studies undertaken in the preparation of these 
regulations is that HACCP plans will take each establishment some time 
and money to develop, and will be considered by the establishment to be 
confidential. It follows that some HACCP plans will include 
confidential, commercially valuable information, meeting the definition 
of ``trade secret.'' Plans that incorporate unique time-and-temperature 
regimens to achieve product safety, or other parameters that are 
processor-specific and that are the result of considerable research and 
effort, will ordinarily meet this definition.
    Moreover, a plan is valuable to the establishment that produces it 
for no other reason than that it took work to write. The equity in such 
a product is not readily given away to competitors. FSIS also knows 
from its own experience that establishment configurations tend to be 
unique to individual establishments, or at least have unique features. 
While generic plans will have great utility in many circumstances, they 
serve primarily as models for establishments to develop their own 
plans. Establishments will still have to expend time and money to 
tailor HACCP to their individual

[[Page 38822]]

circumstances. Thus, at least some HACCP plans or other records will 
include information to which FSIS has access but which FSIS will not be 
required to disclose publicly under FOIA.
    It should be noted, in this regard, that FOIA is not a 
confidentiality statute, but has as its primary purpose the assurance 
of the public's right of access to Government information. Agencies 
must grant requests that ``reasonably describe'' information sought in 
agency files that is not exempt from mandatory disclosure. For this 
reason, FSIS understands that it cannot make promises of 
confidentiality that exceed the permissible boundaries established 
under FOIA.

FSIS Enforcement Authority and Whistleblower Protection

    A large number of commenters requested that FSIS endorse 
enforcement tools contained in the proposed Family Food Protection Act 
(H.R. 1423, S. 515), including strengthened authority to refuse or 
withdraw inspection from official establishments, assessment by the 
Secretary of civil penalties for violations of the inspection laws, and 
protection of ``whistleblowers'' from harassment, discrimination, 
prosecution, and liability. Within the meaning of the proposed 
legislation, whistleblowers are employees or other persons who assist 
or demonstrate an intent to assist USDA in achieving compliance with 
the laws and regulations, refuse to violate or assist in violating the 
law, or are involved in commencing or testifying in a legal proceeding 
conducted by USDA.
    FSIS has determined that, while additional legislative authority 
would be helpful in certain areas, it is not needed to implement HACCP 
and the other requirements established in this final rule.
    As to whistleblower protection, many comments urged that these 
regulations include such protection for employees of meat and poultry 
slaughtering or processing establishments. Whistleblower protection is 
designed to protect workers from being fired or otherwise discriminated 
against for revealing wrongdoing by their employers. The wrongdoing in 
this case would presumably involve the forced falsification of HACCP 
records or other interference with proper operation of the HACCP 
system.
    One concern raised by these commenters and others about the 
credibility of a HACCP system is that important records can be 
falsified. It is alleged that, without whistleblower protection, it is 
much less likely that FSIS will know about falsifications. It was also 
suggested that there is a need to encourage and protect employees who 
report food safety problems or other violations of the inspection laws.
    While FSIS is confident that it can detect falsification in the 
course of its routine reviews of establishment records, coupled with 
in-plant observations, FSIS also expects that, as is now the case, it 
will be alerted by establishment employees to possible wrongdoing even 
in the absence of whistleblower protection. FSIS has relied on 
information provided by employees of the regulated industries for many 
years. From time to time, information is provided with an expectation 
that the identity of the informant will be kept confidential. FSIS 
provides this protection, to the extent possible. This policy has been 
effective.
    As a legal matter, FSIS is not empowered by the FMIA and PPIA to 
build explicit whistleblower protection into the regulations. In 
contrast to the explicit statutory whistleblower protection accorded 
Government employees, the FMIA and PPIA do not provide for 
whistleblower protection for industry employees of the kind suggested 
by some commenters, and no such explicit protection is included in the 
final rule.
    FSIS believes, however, that certain features of the HACCP 
regulations being adopted and the manner in which FSIS will inspect 
meat and poultry establishments compensate for the lack of formal 
whistleblower protection, for purposes of ensuring food safety. Most 
importantly, each establishment will be required to document, through 
records kept by establishment employees, that the critical limits 
required to ensure food safety are being met and when a failure occurs, 
proper corrective action is taken. The failure to document safety-
related failures and to take necessary corrective action violates HACCP 
regulations and the establishment will be subject to appropriate 
regulatory action. Moreover, the falsification of required HACCP 
records is a serious violation of Federal criminal law and will be 
investigated and pursued aggressively by FSIS.
    Establishments that conscientiously implement HACCP will, in the 
course of normal operations, support employee reports of HACCP 
deviations or other potential hazardous processing conditions and take 
immediate corrective action. HACCP systems in which employees with 
HACCP responsibilities are prevented or deterred from carrying out 
their responsibilities will be considered inadequate, and FSIS will 
pursue appropriate enforcement action.
    By virtue of the extensive presence of FSIS inspectors in meat and 
poultry establishments and the daily access of FSIS inspectors to HACCP 
records, FSIS will be able to verify whether problems are being 
properly documented and addressed and will be able to observe potential 
food safety problems that establishments have not found or are not 
confronting in an appropriate manner. FSIS emphasizes that undetected 
or uncorrected conditions which are likely to cause foodborne illness 
or injury should be reported immediately to FSIS by any person with 
knowledge of their existence.

Enforcement and Due Process

    A significant number of commenters raised concerns about the level 
of discretion inspection personnel will have in suspending 
establishment operations due to alleged deficiencies in either the 
design or the operation of a HACCP plan. Some urged FSIS to make clear 
to inspection personnel that such extreme actions are to be reserved 
only for situations in which continued operation of the establishment 
presents an imminent public health risk. Others strongly argued that 
operations should be suspended or inspection withdrawn when an 
establishment fails to comply with any HACCP requirements. 
Clarification was requested regarding the imposition of penalties and, 
specifically, what circumstances would warrant suspension of operations 
or withdrawal of inspection.
    Generally, the nature of the enforcement action taken will vary, 
depending on the seriousness of the alleged violation. Minor violations 
of the HACCP requirements may be recorded by Agency personnel to 
determine establishment compliance trends. Minor violations may also 
result in intensified inspection to ensure that there is no pattern of 
noncompliance and that there is no underlying food safety concern.
    Conversely, serious, repeated, or flagrant violations will result 
in immediate regulatory action, such as stopping production lines; 
applying ``U.S. Rejected'' tags to involved equipment, lines, or 
facilities; retention of product, and suspension or withdrawal of 
inspection. Because of the importance of recordkeeping to the 
functioning of HACCP systems and the production of foods that are safe 
for human consumption, FSIS views recordkeeping as a serious matter 
with potentially grave implications if records are not properly 
maintained or are falsified.

[[Page 38823]]

    Many commenters were troubled by what they perceived to be limited 
procedural due process afforded to establishments when faced with the 
suspension of inspection due to a finding that the HACCP plan is 
inadequate. FSIS agrees that all findings of inadequacy should be sound 
scientifically and legally, and that suspensions should not be invoked 
in an arbitrary manner. The optimal system would provide an appropriate 
level of protection to establishments without unnecessary delay, 
especially where no factual dispute is likely.
    Based on the comments received on this issue, FSIS has decided not 
to finalize the proposed Rules of Practice at this time. FSIS is 
interested in receiving comments and suggestions on enforcement, 
alternative dispute resolution, and due process issues, and has 
included these topics for discussion at the implementation conferences. 
On the basis of the conference discussions, FSIS will complete any 
required rulemaking covering these issues prior to the first 
implementation date for HACCP.

The Final Rule

Reorganization of HACCP Regulatory Text
    FSIS has reorganized the codified regulatory text proposed in the 
Pathogen Reduction/HACCP proposal and reworded a number of the 
provisions. These changes have been made in response to comments 
received on the proposal, for the sake of greater clarity and ease of 
use, and to conform with FSIS's planned reorganization and 
consolidation of all its meat and poultry inspection regulations. In 
general, the final HACCP regulations are more streamlined than the 
proposed provisions, organized in a more logical form, and less 
prescriptive than the proposed regulations. Also, as part of the FSIS 
and FDA effort to adopt a common approach to food safety (described in 
the January 1996 National Performance Review document ``Reinventing 
Food Regulations''), FSIS has made changes to the proposed regulatory 
text, where applicable, to be consistent with FDA's final rule on HACCP 
systems for seafood (60 FR 65096; December 18, 1995).
    To the extent possible, the HACCP requirements for both meat and 
poultry products have been consolidated in a new part 417.
    Requirements affecting grants or refusals of inspection have been 
moved to a new Sec. 304.3 and a new Sec. 381.22.
    FSIS received approximately 7,500 written and many oral comments on 
the proposed rule from meat and poultry slaughter operations, 
processors, retailers, trade and other associations, consumer 
advocates, the scientific and public health community, Federal and 
State government agencies and foreign governments, employees, and other 
interested parties. While a majority of these commenters supported the 
proposal to require adoption of HACCP by meat and poultry 
establishments, they differed widely regarding plan development, 
implementation, and related issues. Comments on the specific proposed 
regulatory requirements and FSIS's responses, follow.
HACCP Systems as a Condition of Receiving Inspection
    Proposed Sec. 326.7(a)(2) and Sec. 381.602(a)(2) would have 
permitted the issuance of a grant of inspection concurrent with a new 
establishment's development and validation of its HACCP plan. This 
provision is confusing because it is unclear how an establishment can 
develop and validate its HACCP plan ``concurrent'' with the granting of 
inspection when the HACCP plan can only be validated on the basis of 
commercial operations and the establishment can operate commercially 
only under inspection. Therefore, it would be impossible for an 
establishment to validate a HACCP plan prior to receiving a grant of 
inspection, as proposed. A number of commenters noticed this difficulty 
and requested that establishments be allowed a reasonable amount of 
time under commercial production to validate their HACCP plans.
    Commenters also disagreed with the proposed HACCP plan development 
timetable for new establishments or establishments producing new 
products or those conducting product test production runs. Some said 
that new establishments and establishments producing new products or 
conducting test runs subsequent to the applicable HACCP effective date 
should have at least six months or up to two years to finalize HACCP 
plans. Others said that all HACCP plans should be developed before 
start-up with revisions allowed within a reasonable period.
    FSIS is in basic agreement with these comments and is revising the 
basic procedures for granting inspection to allow establishments time 
to validate their HACCP plans. The provisions in Secs. 304.3(b) and 
381.22(b) require that any new establishment conduct a hazard analysis 
and develop a HACCP plan prior to being issued a conditional grant of 
inspection. The establishment must validate its HACCP plan within 90 
days after the conditional grant of inspection is issued. After FSIS 
has determined that the establishment has validated its HACCP plan, a 
permanent grant of inspection will be issued. An establishment already 
receiving inspection may produce a new product for distribution only if 
it has developed a HACCP plan applicable to the product and validates 
the plan within 90 days after beginning production of the product.
    FSIS is requiring that new facilities and products be covered by a 
HACCP plan at the time commercial production begins. Establishment 
management is expected to consider development of HACCP systems as part 
of essential pre-production decisions for new operations. 
Establishments are also expected to modify their HACCP plans as needed 
based upon experience and reported results. FSIS has determined that no 
start-up time is needed in these instances since the establishment will 
not be experiencing any transition from an old system to a new 
processing system.
    FSIS is considering what further changes may be necessary in the 
procedures for granting and inaugurating inspection at official 
establishments to better accommodate HACCP-oriented inspection. FSIS 
plans to publish a notice of proposed rulemaking on this matter in the 
near future.
Definitions
    Proposed Secs. 326.1 and 381.601 have been combined, streamlined, 
and redesignated as Sec. 417.1. Thirteen proposed definitions were 
determined to be commonly understood or unnecessary and have been 
removed. Of the seven definitions remaining, the definitions for 
``critical control point,'' ``critical limit,'' ``HACCP system,'' and 
``responsible establishment official'' have been clarified. For 
example, the definition of ``critical control point'' includes the 
phrase ``as a result'' to indicate that the prevention, reduction, or 
elimination of a food safety hazard occurs because of action taken at 
the critical control point. The definition of ``responsible 
establishment official'' has been expanded to include the individual 
with overall authority or a higher level official of the establishment.
    The revised definitions are consistent with those promulgated in 
FDA's final rule on HACCP systems for seafood. For example, FSIS has 
added a new definition to Sec. 417.1 for the term ``process-monitoring 
instrument.'' This term is defined as ``an instrument or device used to 
indicate conditions during processing at a critical control

[[Page 38824]]

point.'' FSIS determined that this definition would be helpful to 
establishments developing HACCP plans.
Hazard Analysis and HACCP Plan
    The proposal required each establishment to develop and implement a 
HACCP plan which incorporated the seven HACCP principles. A hazard 
analysis was to be conducted to identify biological, chemical and 
physical hazards and a list of steps in the process where potentially 
significant hazards could occur and the preventive measures to be taken 
were to be identified.
    Provisions relating to the hazard analysis and development of the 
HACCP plan were proposed as Secs. 326.2 and 381.602, ``Development of 
HACCP Plan,'' Secs. 326.3 and 381.603, ``HACCP Principles,'' and 
Secs. 326.4 and 381.604, ``Implementation of the HACCP Plan.'' These 
provisions have been modified and incorporated into Sec. 417.2.
    Several commenters argued that in the event the hazard analysis 
identified no significant hazards, the establishment should be exempt 
from developing HACCP plans and operating under a HACCP system. 
Commenters identified lard and meat flavoring manufacturers and canning 
operations as examples of establishments that may identify no hazards.
    To clarify the concept of potentially significant hazards, and to 
be consistent with the FDA final rule on HACCP systems for seafood, the 
final rule requires each establishment to conduct, or have conducted 
for it, a hazard analysis to determine the food safety hazards 
reasonably likely to occur in the production process. A food safety 
hazard that is reasonably likely to occur is defined as one for which a 
prudent establishment would establish controls because it historically 
has occurred, or because there is a reasonable possibility that it will 
occur in the particular type of product being processed, in the absence 
of those controls.
    FSIS agrees that if an establishment's hazard analysis reveals no 
hazards, then no HACCP plan would be required. However, FSIS is 
currently unaware of any meat or poultry production process that can be 
deemed categorically to pose no likely hazards. With regard to the lard 
and meat flavoring examples, FSIS believes that reasonably likely 
biological and physical hazards requiring control measures exist in 
establishments manufacturing these products and that, therefore, HACCP 
plans are required.
    FSIS agrees that the microbial hazards associated with canned meat 
and poultry products are eliminated by complying with the regulations 
in 9 CFR Secs. 318.300-311 and 381.300-311. These regulations are based 
on HACCP concepts and provide for the analysis of thermal processing 
systems and controls to exclude microbial hazards. Accordingly, the 
final rule provides that HACCP plans for thermally processed/
commercially sterile products do not have to address the food safety 
hazards associated with microbiological contamination if the product is 
produced in accordance with the canning regulations. However, because 
the current regulations exclusively address microbial hazards, 
processors of canned meat, meat food and poultry products must develop 
and implement HACCP plans to address chemical and physical hazards that 
are reasonably likely to occur.
    The current canning regulations contain numerous prescriptive 
features, including extensive FSIS involvement in the decisionmaking 
process, that are inconsistent with the philosophy underlying HACCP. In 
the advance notice of proposed rulemaking ``FSIS Agenda for Change: 
Regulatory Review'' (60 FR 67469; December 29, 1995), FSIS stated its 
intention to convert the canning regulations to performance standards, 
which are more consistent with HACCP. Until changes in the canning 
regulations are finalized, canning establishments do not have to 
address microbial hazards in their HACCP plans.
    The provisions of proposed Sec. 326.3(a), (a)(1), and (a)(2), and 
Sec. 381.603(a), (a)(1), and (a)(2) relating to process flow charting 
and the identification of intended uses and consumers of the product 
have been combined in the final rule into Sec. 417.2(a)(2).
    Proposed Secs. 326.2(b) and 381.602(b) would have required that any 
HACCP plan be developed with assistance of a HACCP-trained individual 
employed by the establishment, that the individual's name and resume be 
on file, and that the individual meet other prescriptive requirements. 
These requirements have been removed in response to criticism expressed 
in comments received and for reasons given below in the discussion of 
Sec. 417.7. The new Sec. 417.2(a)(1) permits someone other than an 
establishment employee to conduct the hazard analysis.
    Proposed Secs. 326.3(a) and 381.603(a) would have required a hazard 
analysis to identify any biological (including microbiological), 
physical, or chemical hazards. In Sec. 417.2(a)(3), FSIS lists ten 
areas that should be considered by an establishment when performing its 
hazard analysis. These ten areas are: natural toxins; microbiological 
contamination; chemical contamination; pesticides; drug residues; 
zoonotic diseases; decomposition; parasites; unapproved use of direct 
or indirect food or color additives; and physical hazards. This list of 
possible hazards provides more complete guidance to establishments 
conducting a hazard analysis; it responds to industry comments 
criticizing as ``vague'' the proposed definition of hazard; and it is 
also consistent with the list of hazards in FDA's final rule on HACCP 
systems for seafood.
    Proposed Secs. 326.2(a) and 381.602(a) would have required that 
establishments develop, implement, and operate a HACCP plan for each 
process conducted by the establishment, and provided a list of process 
categories subject to this requirement. Section 417.2(b) provides that 
each establishment develop and implement a HACCP plan covering each 
product produced, whenever its hazard analysis reveals one or more food 
safety hazards that are likely to occur. This requirement is 
substantively the same as the proposal.
    Section 417.2(b)(1) provides a revised list of process categories, 
while Sec. 417.2(b)(2) states that a single HACCP plan may encompass 
multiple products within a single processing category, if the hazards, 
CCP's, and critical limits are essentially the same, and as long as any 
plan features that are unique to a specific product be clearly set out 
in the HACCP plan and observed in practice. For example, an 
establishment's HACCP plan for the processing of cooked sausage might 
cover bologna, knockwurst, and frankfurters that the establishment 
produces.
    Proposed Secs. 326.2(d) and 381.602(d) would have required that the 
HACCP plan be developed in two stages, both to be completed six months 
prior to the phase-in date of the applicable process category or upon 
application for inspection or when a new process is ready for 
implementation. FSIS has eliminated these requirements because they are 
impractical.
    Proposed Secs. 326.2(d)(1) and 381.602(d)(1) would have required 
that every HACCP plan be in a format similar to the NACMCF and FSIS 
generic models. FSIS agrees with those commenters who found this 
proposed requirement to be unnecessary and too prescriptive, and has 
not included this requirement in the final rule.
    Proposed Secs. 326.3 and 381.603 set forth the seven HACCP 
principles accompanied by the corresponding requirements establishments 
must meet when developing HACCP plans. In response to comments that the 
detailed

[[Page 38825]]

provisions were unnecessary, FSIS has set forth in Sec. 417.2(c) a 
simplified list of requirements, based on the seven HACCP principles, 
to be met by establishments when developing HACCP plans. The proposed 
requirements remain, except for the following additions, unchanged.
    Two subparagraphs have been added to new Sec. 417.2(c)(2), 
clarifying the requirements for the identification of CCP's within a 
HACCP plan. This new section requires that establishments list in their 
HACCP plan the CCP's for each of the identified food safety hazards, 
including, as appropriate: (1) CCP's designed to control food safety 
hazards that could be introduced in the establishment, and, (2) CCP's 
designed to control food safety hazards that may have been introduced 
into the product before, during and after its entry into the 
establishment. In response to comments objecting to the proposed 
requirement for establishments to use a decision tree in identifying 
CCP's (proposed Sec. 326.3(b) and 381.603(b)), this requirement has 
been removed from the final rule.
    Proposed Secs. 326.4 and 381.604 would have required that a 
responsible establishment official, formerly defined as ``the 
management official located on-site at the establishment who is 
responsible for the establishment's compliance with this part,'' 
review, approve, and sign the HACCP plan. Section 417.2(d)(1) requires 
that the HACCP plan be signed by the responsible establishment 
official, defined as the individual with overall authority on-site or a 
higher level official of the establishment, possibly off-site. Further, 
in Sec. 417.2(d)(2), FSIS is correcting an oversight in the proposal by 
requiring that the HACCP plan must be signed and dated upon initial 
acceptance by the establishment and at any time the plan is modified. 
The proposal required that the responsible establishment official sign 
the plan upon completion of the hazard analysis and the development of 
the HACCP plan. The HACCP plan must also be signed and dated at least 
once each year after the required reassessment.
    Finally, FSIS explicitly states its statutory authority to enforce 
the HACCP regulations under Sec. 417.2(e), providing that if an 
establishment fails to develop and implement a HACCP plan or to operate 
in accordance with the requirements of this part, the products produced 
by the establishment may be deemed adulterated.
Corrective Actions
    Proposed Secs. 326.3(e) and 381.603(e) would have required that 
each establishment develop corrective actions to be taken when there is 
a deviation from an established critical limit. Under the proposed 
provisions, if a deviation were found, the establishment would describe 
the steps taken to identify and correct the deviation, determine how 
noncompliant product would be handled, ensure that no safety hazards 
exist after the corrective actions are taken, and define measures to 
prevent recurrence. Further, this section required that the 
establishment determine whether its HACCP plan required modification 
and, if so, to modify the plan.
    Many commenters stated that establishments should be empowered to 
make decisions on product safety. Commenters generally maintained that 
the establishment should have primary responsibility for setting the 
CCP's and critical limits and for taking corrective action when there 
is a deviation. Inspectors should verify the overall effectiveness of 
the HACCP plans, including the corrective actions taken by 
establishments. A number of commenters were concerned about the 
possibility that FSIS might take action on a product if a critical 
limit in the establishment's HACCP plan was not met, even if the 
establishment were taking corrective action under the plan. Commenters 
felt that this action by FSIS would be unwarranted. An additional 
concern was that the potential for this type of problem would be 
compounded if the establishment set a critical limit more restrictive 
than necessary for food safety to meet quality standards, for example, 
a higher cooking temperature than necessary to produce a pathogen-free 
product.
    The establishment must take corrective action for any deviation 
from a set critical limit. FSIS will verify that the establishment has 
taken appropriate corrective action as specified in their HACCP plan. 
If an establishment fails to take corrective action as specified in its 
HACCP plan, FSIS may find that the HACCP system is inadequate pursuant 
to Sec. 417.6(c). FSIS agrees that establishments should be empowered 
to make decisions regarding product disposition in accordance with 
corrective actions specified in their HACCP plans. FSIS is requiring 
(Secs. 417.2(c)(5) and 417.3) that establishments describe in their 
HACCP plans the corrective actions that will be taken if a critical 
limit is not met and assign responsibility for taking corrective 
action. Corrective actions must ensure that no product that is 
injurious to health or is otherwise adulterated as a result of the 
deviation enters commerce, that the cause of the deviation is 
identified and eliminated, that the CCP will be under control after the 
corrective action is taken, and that measures to prevent recurrence are 
established.
    FSIS recognizes that preestablished corrective actions may not 
cover every contingency and that unforeseen hazards or deviations may 
occur. Thus, Sec. 417.3 of the regulations provides a series of steps 
to be taken in such situations. These steps include segregating and 
holding affected product and conducting a review to determine the 
acceptability of the product for distribution, ensuring that any 
adulterated product or product otherwise injurious to health does not 
enter commerce, and reassessing HACCP plans to determine if any 
modification is needed.
Validation, Verification, and Reassessment
    Proposed Secs. 326.3(g) and 381.602(g) would have required that 
establishments develop procedures for HACCP plan validation by an 
adequately trained individual, and set forth the related requirements. 
Proposed Secs. 326.4 and 381.604 further detailed the validation 
requirements, stating that during the validation period, establishments 
shall conduct repeated verifications of the plan, hold frequent 
meetings with Program employees, and review records generated by the 
HACCP system. Under the proposal, establishments were to modify their 
HACCP plan following any ingredient change, product reformulation, 
manufacturing process or procedure modification, equipment change, or 
any other such change. Revalidation of an establishment's HACCP plan 
would have been required whenever significant product, process, 
deviations, or packaging changes required modification of the plan.
    Many commenters expressed confusion about the meaning of the terms 
``validation'' and ``verification'' as used in the proposed rule. The 
question of who will be responsible for validating HACCP plans was 
raised by a number of commenters. Some requested a clearer definition 
of the term ``validation'' as well as clarification of who will approve 
and verify a HACCP program. Particular concern was expressed about what 
role local inspection personnel will have in the HACCP plan development 
and approval process. Some said that FSIS should assume more 
responsibility for approving HACCP plans through a prior approval 
system; others argued that no formal acceptance or prior approval of

[[Page 38826]]

HACCP plans by FSIS should be required.
    In the final rule, FSIS has clarified the concepts of 
``validation'' and ``verification'' by delineating the responsibilities 
of FSIS and establishments in separate codified sections. The initial 
validation, ongoing verification, and reassessment procedures to be 
followed by establishments are presented in Sec. 417.4 and FSIS's 
verification procedures are presented in Sec. 417.8.
    Because prior approval of HACCP plans by FSIS would be contrary to 
redefined roles and responsibilities inherent in the HACCP philosophy, 
FSIS will not approve or validate HACCP plans before an establishment 
implements its HACCP system. Each establishment will be responsible for 
developing its HACCP plan and ensuring its adequacy.
    Commenters opposed to FSIS involvement in plan validation offered 
two suggestions: (1) establishments could use an independent third 
party, such as a processing authority or consultant with HACCP 
expertise to validate HACCP plans or (2) HACCP-trained establishment 
employees could validate plans.
    FSIS concurs. Establishments will be required to have validated 
plans and may use independent consultants, process authorities, or 
establishment employees trained in accordance with Sec. 417.7 for plan 
development and validation. FSIS is not prescribing that any particular 
validation method be used.
    Some establishments may choose to use the services of laboratories 
or processing authorities to validate their CCP's, especially if there 
are questions about the effectiveness of traditional controls, or if 
they are considering use of controls which have not been previously 
validated, such as cooking time/temperature combinations. However, many 
establishments will choose to rely on CCP's that have been 
scientifically validated and reported in the literature. In either 
case, FSIS believes that requiring individual establishments to 
validate their HACCP plan ensures that the CCP's and the overall HACCP 
plan work as intended in the establishment to reduce or eliminate 
hazards and prevent the production of unsafe food.
    One industry member observed that his company defines validation as 
documenting that a critical control point eliminates or effectively 
addresses microbiological hazards.
    FSIS agrees that validation includes documenting that critical 
control points effectively address relevant hazards, including such 
microbiological hazards as E. coli O157:H7, Salmonella, and 
Campylobacter, but emphasizes that validation is more than just the 
accumulation of microbiological data verifying each CCP. It involves 
scientifically demonstrating that a HACCP system as designed is 
effective in controlling the food safety hazards identified through the 
hazard analysis.
    One academic commenter advocated inoculation studies using 
pathogens as the best way to assure that a HACCP plan will effectively 
control microbiological hazards. Such studies would be conducted before 
HACCP implementation and should be aimed at demonstrating that selected 
CCP's are appropriately monitored to control specific pathogens. The 
studies would be performed under controlled conditions in off-site 
laboratories or pilot establishments. One advantage of this approach, 
according to the commenter, would be to permit validation studies to be 
conducted by trade associations and other industry groups on a 
collective basis in a way that could benefit both large and small 
establishments.
    FSIS agrees that validation of CCP's is an important part of HACCP 
plan validation, and that laboratory inoculation studies as suggested 
by the commenter can make an important contribution in appropriate 
cases. Inoculation studies can demonstrate the effectiveness of 
particular controls in addressing particular hazards under experimental 
conditions, and can produce data that can be relied upon by many 
establishments to support plan validation. In no case, however, would a 
laboratory inoculation study or any laboratory study be sufficient by 
itself to validate a HACCP plan. An important element of validation is 
the identification or development of data which show that the 
establishment can apply the process or control to get the anticipated 
effect under actual in-plant operational conditions. For some well-
established, widely used processes or technologies, in-plant validation 
can be accomplished by combining existing scientific data from 
laboratory studies, the scientific literature, or other sources, with 
the results of commercial trials using recognized protocols. Where 
processes are well-documented in the scientific literature, it is not 
necessary to require inoculation studies or any other research effort 
as part of the validation process. However, an establishment 
introducing a new technology, applying standard technology in an 
unusual way, or lacking experience with a technology, would have to 
undertake more extensive scientific and in-plant validation of its 
HACCP plan under commercial operating conditions.
    Data assembled to validate a HACCP plan are usually of two types: 
(1) theoretical principles, expert advice from processing authorities, 
scientific data, or other information demonstrating that particular 
process control measures can adequately address specified hazards, such 
as studies establishing the temperatures necessary to kill organisms of 
concern; and (2) in-plant observations, measurements, test results, or 
other information demonstrating that the control measures, as written 
into a HACCP plan, can be operated within a particular establishment to 
achieve the intended food safety objective. This means that the data 
used to validate a HACCP plan may be derived from various sources, 
including the scientific literature, product testing results, 
experimental research results, scientifically based regulatory 
requirements, FSIS guidelines, computer-modeling programs, and data 
developed by process authorities. The nature and quantity of 
information required to validate a HACCP plan will vary depending on 
factors such as the nature of the hazard and the control measures 
chosen to address it.
    FSIS believes that validation data for any HACCP plan must include 
some practical data or information reflecting an establishment's actual 
early experience in implementing the HACCP plan. This is because 
validation must demonstrate not only that the HACCP plan is 
theoretically sound, but also that this establishment can implement it 
and make it work. For example, steam vacuuming has been scientifically 
demonstrated to be effective in removing visible contamination and 
associated bacteria from carcass surfaces. A slaughtering establishment 
using the technology as a control measure at a CCP, however, would 
still have to demonstrate its ability to use the technology effectively 
at the CCP.
    Establishment verification is intended to show that the HACCP 
system is actually working effectively on a day-to-day basis. 
Verification also includes repeatedly reviewing and evaluating the 
various components of the system. Verification activities include 
checking the adequacy of the critical limits; reviewing monitoring and 
recordkeeping procedures (as distinguished from monitoring the CCP's), 
and evaluating the adequacy of corrective actions.
    One consumer group stated that FSIS should require that 
establishments identify the specific microbiological hazards that their 
HACCP plans are

[[Page 38827]]

designed to address, and validate and verify the plans using pathogen-
specific testing to ensure that establishments control these hazards.
    FSIS agrees that establishments must identify the specific 
microbiological hazards their HACCP plans are designed to address and 
that the plan must be initially validated and continually verified as 
effective in addressing those hazards. FSIS also agrees that pathogen-
specific testing can play an important role in both initial validation 
and verification.
    For example, in validating the adequacy of a beef slaughter HACCP 
plan addressing the hazard posed by E. coli O157:H7, laboratory 
inoculation studies involving pathogen-specific testing could be used 
to validate the effectiveness of the specific control measures that an 
establishment is considering for incorporation in its HACCP plan. As 
discussed above, to complete the validation of the control measures for 
E. coli O157:H7, the establishment would also be required to 
demonstrate that the experimentally validated measures can be 
successfully carried out under actual operating conditions, but, for E. 
coli O157:H7 on going verification is unlikely to include in-plant 
testing for the pathogen due to its relatively infrequent occurrence.
    In-plant testing to verify a control measure may be appropriate 
with other pathogens, however. For example, a poultry slaughter 
establishments would be required to validate and verify the 
effectiveness of its HACCP plan in addressing the hazards posed by 
Salmonella and Camplylobactor. Depending on the nature of the control 
measures the establishment selects, in-plant pathogen testing could be 
a necessary and practical component of an on-going verification for 
these pathogens as they are present in sufficient numbers to make in-
plant testing feasible and informative. FSIS intends to work closely 
with industry at large and with specific establishments in particular 
to ensure that HACCP plans are adequately validated and verified for 
microbial pathogens of public health concern.
    Verification of HACCP plans by establishments is designed to 
demonstrate that the HACCP plan is accomplishing process control and 
resulting in the production of safe food on a continuing basis. 
Verification is distinct from ongoing establishment monitoring, which 
is designed to provide a record showing that the written HACCP plan is 
being followed. Establishment verification activities should provide 
practical results specific to the operation of its HACCP plan, and can 
include review of CCP-monitoring records; review of corrective action 
records; calibration of process-monitoring instruments; collection of 
either in-line or finished product samples for microbiological, 
chemical, or physical analysis; and direct observations of monitoring 
activities and corrective actions. Frequencies for conducting 
verification activities will vary, depending on various factors, such 
as the type of process and volume of products, the results of prior 
verification activities, consistency of conformance with the HACCP 
plan, how deviations are handled, and the results of any sampling 
activities.
    The record-verification could include determining whether the 
critical limit for the CCP, as called for in the HACCP plan, matches 
the critical limit indicated in the records. The verification could 
also involve checking to assure that the critical limit as set in the 
establishment's HACCP plan is adequate to prevent a hazard. For 
example, this check might involve determining whether the random 
variations inherent in any process are within the limits (temperature 
ranges, physical contamination) set for the process, and that the 
critical limit is never exceeded or, further, that the probability that 
the critical limit might ever be exceeded is extremely low.
    The visual observations and records verification could include, in 
addition to seeing that the records are being properly maintained, 
assuring that corrective actions have been taken whenever any 
deviations have occurred and that, when taken, the corrective actions 
were sufficient to solve the problem.
    FSIS has made two minor changes from the proposed validation and 
verification requirements. First, FSIS has removed the proposed 
requirement that during validation an establishment hold frequent 
meetings with Program employees. FSIS recognizes that frequent meetings 
may not be necessary or appropriate. Also, Sec. 417.4(a)(2) provides 
that the establishment's ongoing verification activities include direct 
observation of monitoring activities and corrective actions, review of 
records, and calibration of process-monitoring instruments. An 
establishment calibrates its monitoring instruments to determine 
whether they are functioning properly.
Reassessment
    The proposed rule would have required that establishments 
revalidate the HACCP plan whenever significant product, process, 
deviations, or packaging changes required modification of the plan.
    A consumer group stated that establishments should be required to 
examine their plans on a regular basis, whenever any new equipment is 
introduced, new employee training is implemented, or for any other 
significant change in the processing environment. The commenter further 
stated that revalidation should be required of establishments every 
three years even if there has been no significant change in operations. 
Most commenters generally agreed that the industry has the primary 
responsibility to review and modify HACCP plans when necessary and that 
the review and modification process should be flexible.
    FSIS agrees that HACCP plans should be reexamined periodically and 
that the review and modification process should be flexible. The final 
rule requires that each establishment reassess the adequacy of its 
HACCP plan at least annually, and whenever any changes occur that could 
affect the hazard analysis or alter the HACCP plan (Sec. 417.4(a)(3)). 
These changes may include, but are not limited to, changes in: raw 
materials or source of raw materials; product formulation; slaughter or 
processing methods or systems; production volume; personnel; packaging; 
finished product distribution systems; or the intended use or consumers 
of the finished product. The reassessment must be completed by an 
individual trained in accordance with Sec. 417.7. Immediate 
modification of the plan is required if the reassessment reveals that 
the plan is no longer adequate to meet the requirements of part 417. 
FSIS is also requiring that an establishment that does not have a HACCP 
plan reassess its hazard analysis whenever a change occurs that could 
reasonably affect whether a food safety hazard exists.
    FSIS considers annual reassessment appropriate because, as 
commenters have noted, HACCP plans are dynamic and evolving. HACCP 
plans may be modified several times during the months after they are 
first implemented. Further, repeating the entire validation process may 
not be necessary to ensure that the HACCP system is functioning 
correctly after modification.
    The intent of this provision is to provide for periodic 
modification of the HACCP plan to ensure that it is continuously 
effective in controlling and preventing food safety hazards. This 
intent is supported by comments received from various sectors of the 
public. The commenters tended to see periodic review and modification 
of HACCP plans as both desirable and

[[Page 38828]]

expected and that periodic review and modification would allow the 
establishment to apply its experience to continually improve process 
controls.
    FSIS believes that ``reassessment'' encompasses the different types 
of evaluation, from reanalyzing the verification procedures for an 
updated CCP to repeating the validation procedures set forth in 
Sec. 417.4, that may be necessary.
FSIS Verification
    Verification of HACCP plans is also a regulatory responsibility. 
FSIS will verify that HACCP plans comply with the requirements of Part 
417 and have been validated by the establishment. Potential 
verification activities by FSIS may include, but are not limited to, 
sampling activities (targeted and non-targeted, marketplace, rapid 
screening tests for chemical residues); hands-on verification 
(organoleptic inspection, use of temperature or other monitoring 
devices); and review of establishment monitoring records. The frequency 
of FSIS verification activities will vary, depending on a number of 
factors such as the establishment's past performance, risk inherent in 
the processes or products, quantity of product, and likely uses.
    A consumer group stated that as part of its verification 
activities, FSIS should review all pathogen data generated by the 
establishment to determine the adequacy of the establishment's 
conclusions regarding pathogen control. FSIS plans to undertake 
extensive and varied activities to verify that a HACCP plan is working 
as intended, including review of data generated or relied on by the 
establishment to validate its HACCP plan.
    Proposed Secs. 326.7(b) and 381.607(b) set forth FSIS's 
responsibilities with respect to verification activities. These 
provisions have been slightly revised for clarity and are consolidated 
in Sec. 417.8.
Records
    Proposed Secs. 326.6(b) and 381.606(b) listed the types of records 
every establishment would have been required to maintain regarding 
their operations under HACCP. The list included the written HACCP plan, 
hazard analysis, records associated with CCP monitoring, corrective 
actions, verification procedures and results, product codes, identity, 
and slaughter production lot, the dates of the records, and supporting 
documentation for the various features of the HACCP plan. FSIS also 
proposed to require a preshipment review of processing and production 
records associated with the HACCP plan to ensure that the records were 
complete, that all critical limits were met, and, if applicable, that 
corrective actions were taken. The review was to be performed by 
someone other than the person who created the records, preferably by a 
HACCP-trained individual, or by the responsible establishment official. 
FSIS considers the preshipment record review a routine verification 
function under HACCP principle No. 7.
    FSIS also proposed that establishments retain all required records 
on site at all times, except those records concerning monitoring CCP's, 
corrective actions, and verification procedures were to be retained at 
the establishment for no less than one year, and for an additional two 
years at the establishment or other location from which the records 
could be made available to Program employees.
    Regarding the preshipment review of records, several small 
establishments commented that there may not be a person other than the 
person who created the record available to conduct the preshipment 
review. Several large establishments were concerned that a HACCP-
trained individual may not be available to conduct the preshipment 
review. FSIS has modified this requirement by stating that the 
preshipment review shall be conducted by someone other than the person 
who produced the records where practicable. Also, FSIS has retained the 
provision that the review be conducted preferably by an individual 
trained in accordance with Sec. 417.7 or the responsible establishment 
official.
    Some commenters recommended that FSIS allow the use of electronic 
or computerized recordkeeping systems to ease the burden of the 
proposed recordkeeping requirements. In response to these comments, 
FSIS has added a new Sec. 417.5(d) which provides for the maintenance 
of data and information on computers, as long as controls are 
implemented by the establishment to ensure the integrity of the data 
and signatures.
    Commenters also raised concerns regarding proposed record retention 
requirements, maintaining that keeping HACCP records for a minimum of 
three years would be excessive. Commenters requested flexibility in 
deciding how long to retain records; many stated that retention should 
be based on product shelf-life. In response to these commenters, FSIS 
has modified this requirement to provide that records required by 
Sec. 417.5(a)(3) be retained at the establishment for one year if they 
pertain to slaughter activities or refrigerated products, and for two 
years if they pertain to frozen, preserved, or shelf-stable products.
    To further ease the recordkeeping provisions for establishments, 
FSIS will permit the off-site storage of records required by 
Sec. 417.5(a)(3) that are over 6 months old if the records can be made 
available to Program employees within 24 hours of the request. The 
records required by Sec. 417.5 (a)(1) and (a)(2), however, are not 
eligible for off-site storage.
    Proposed Secs. 326.6 and 381.606 would have provided that records 
be made available to Program employees. Section 417.5(f) clarifies that 
all records required by part 417 be available to Program employees for 
review and copying.
    For clarity, FSIS has reworded the recordkeeping provisions to 
require that the establishment maintain the written hazard analysis and 
all supporting documentation, the written HACCP and all decisionmaking 
documents associated with the selection and development of CCP's and 
critical limits, and documents supporting both the monitoring and 
verification procedures selected and the frequency of those procedures. 
Records documenting the monitoring of CCP's and critical limits, 
corrective actions, verification procedures and results, product 
code(s), product name or identity, or slaughter production lot must 
also be maintained. Each record must include the date the record was 
made. To be consistent with FDA's final rule on HACCP systems for 
seafood, FSIS has also added a requirement that records relating to the 
calibration of process-monitoring instruments be maintained.
Training
    FSIS proposed two definitions related to training: ``HACCP-trained 
individual'' and ``recognized HACCP course.'' ``HACCP-trained 
individual'' was defined as ``a person who has successfully completed a 
recognized HACCP course in the application of HACCP principles to meat 
or poultry processing operations, and who is employed by the 
establishment. A HACCP-trained individual must have sufficient 
experience and training in the technical aspects of food processing and 
the principles of HACCP to determine whether a specific HACCP plan is 
appropriate to the process in question.'' A ``recognized HACCP course'' 
was defined as ``a HACCP course available to meat and poultry industry 
employees which satisfies the following: consists of at least 3 days, 1 
day devoted to understanding the seven principles of HACCP, 1 day 
devoted to applying these concepts to this and other regulatory 
requirements of FSIS, and 1 day devoted

[[Page 38829]]

to beginning development of a HACCP plan for a specific process.''
    Some commenters thought that defining a HACCP-trained individual 
was unnecessary, that the role of such a person in operating HACCP 
systems should be analogous to the role of the processing authority in 
canning operations.
    A few commenters questioned the effectiveness of the proposed 
three-day training requirement stating it would not sufficiently 
qualify a person to implement or operate a HACCP system. Some 
commenters asserted that the detailed course composition with no FSIS 
certification of courses was inadequate and too rigid. Others insisted 
that what is needed is a common understanding of the basic principles 
of HACCP and of how HACCP can be applied to specific processes and 
establishments, with no FSIS certification of courses.
    FSIS has revised the regulations, which are now codified in 
Sec. 417.7, to simplify the proposed training requirements. The 
proposed definition and requirements for a HACCP-trained individual 
have been removed. Section 417.7 requires that individuals performing 
certain functions must have successfully completed a course in the 
application of the seven HACCP principles to meat and poultry product 
processing, including a segment on the development of a HACCP plan for 
a specific product. Only those individuals who meet the training 
requirements may perform the following functions:
     Development of the HACCP plan as required by 
Sec. 417.2(b);
     Reassessment and modification of the HACCP plan as 
required by Sec. 417.3 and/or Sec. 417.4(a)(3).
    The rule has been modified to set a basic standard for HACCP 
training while preserving the flexibility needed by industry to 
implement HACCP systems effectively. The provisions of Sec. 417.7 are 
consistent with FSIS's view that training is central to the success of 
HACCP, that there are many avenues for HACCP training needs, and that 
responsible establishment officials are in the best position to 
determine the training needs for each establishment.
Adequacy of HACCP Plans
    The proposed rule stated that a HACCP plan could be found invalid 
if it does not meet the regulatory requirements, if HACCP records are 
not being maintained 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.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:

     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.
     E. coli occurs at a higher frequency than Salmonella, 
and quantitative E. coli testing permits more rapid and more 
frequent adjustment of process control.
     E. coli has survival and growth characteristics similar 
to enteric pathogens, such as E. coli O157:H7 and Salmonella.
     Analysis for E. coli poses fewer laboratory safety 
issues and testing at the establishment site is more feasible than 
such testing with Salmonella.
     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.'' 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.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
Marginal--result > m and  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........................  (1)..................          100
Cow/Bull............................  (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/cm2 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.5,6 and for Campylobacter jejuni/coli.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.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.
---------------------------------------------------------------------------

    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.9 and others, including Gill et 
al.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.
---------------------------------------------------------------------------

    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 cm2 at each of the three sites be 
sampled by swabbing, for a total area of 300 cm2 compared to the 
60 cm2 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/cm2) 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'' 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.
---------------------------------------------------------------------------

     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.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.

[[Page 38856]]

Cooling and Chilling Requirements for Raw Meat and Poultry

    FSIS proposed that establishments slaughtering livestock be 
required to chill carcass surfaces and hot-boned meat to 50 deg.F 
(10 deg.C) within 5 hours and then to 40 deg.F (4.4 deg.C) within 24 
hours of slaughter or meat and bone separation. Chilling of meat 
products such as liver and cheek meat would have been required to begin 
within one hour of removal from a carcass. The proposed rule also would 
have changed existing poultry chilling requirements (Sec. 381.66) to be 
comparable with those proposed for meat. Chilling would have been 
required unless the raw product was going directly from slaughter to 
heat processing.
    The proposal also would have required that establishments maintain 
raw meat and poultry products at an internal temperature of 40 deg.F or 
below while in the establishment and before release into commerce. Raw 
products not chilled in accordance with the requirements would have 
required further processing to kill pathogens or would be condemned.
    Lastly, the proposal would have required each establishment 
handling raw product to have a written plan for temperature controls 
and monitoring and make monitoring records available to FSIS upon 
request.
    The proposed rule was based on good manufacturing practices 
generally prevalent in the industry. FSIS's position was that 
temperature controls, which are known to prevent bacterial growth, are 
an accepted part of current industry practices, are already required by 
regulation for poultry carcasses, and should be mandated for all raw 
product to minimize the possibility that raw products leaving official 
establishments bear significant levels of pathogenic microorganisms.
    Commenters generally supported the concept that establishments 
should be required to chill raw product as a means of minimizing the 
growth of harmful bacteria. Some commenters supported the time and 
temperature requirements as proposed. Others argued that the specific 
time and temperature combinations in the proposed rule were unduly 
restrictive and unworkable. A number of commenters advocated ``more 
realistic'' cooling requirements that take into consideration 
establishment and product variety, different processing operations, and 
diverse shipping and receiving operations. These commenters supported 
the use of independent ``process authorities'' to advise establishments 
on cooling carcasses and other raw products. Some suggested that the 
proposed chilling requirements should be recast as guidelines.
    Many commenters questioned the need for any regulatory requirements 
for chilling and asserted that it was conceptually at odds with the 
proposed HACCP provisions. They recommended that FSIS defer any 
regulation on chilling because establishments would have to address 
chilling as part of their HACCP plans.
    Some commenters raised concerns about the scientific basis of the 
proposed time and temperature requirements. They asserted that the 
cooling requirements would not result in any demonstrable improvement 
in food safety because they were not based on scientifically valid 
data. A number of commenters said that the proposed time and 
temperature requirements were simply not achievable by the beef 
industry due to the large size of beef carcasses. Also, they said that 
these carcass cooling requirements might change meat quality attributes 
such as product texture and palatability.
    Many commenters asserted that FSIS's regulatory focus and the 
economic burdens are placed entirely on establishments when, these 
commenters argue, a large proportion of foodborne illnesses are caused 
by temperature abuse and other mishandling of raw products after they 
leave the establishment.
    Many commenters expressed concern about risks to employees' health 
that could result from employees working continuously in a colder 
environment. They cited worker safety studies showing many human 
physical ailments are created or aggravated by cold ambient 
temperatures. Worker safety was also cited as an issue on the grounds 
that the difficulty of handling and cutting meat at such cold 
temperatures increases the potential for accidents and injuries.
    Some commenters noted that FSIS did not specify how the equivalence 
of alternative procedures could be established. In addition, some 
suggested specific alternative methodologies they thought would provide 
equivalent procedures, such as cooling with dry ice, CO2, or 
nitrogen. Others either did not approve of using any alternative 
chilling process or wanted them to be included in the final rule.
    Some commenters questioned the rationale for proposing identical 
requirements for meat and poultry. They said that using the same set of 
requirements for all species fails to take into account the variation 
in carcass size.
    Commenters from small businesses said they did not have the cooling 
capacity to comply with the proposed requirements, and that the cost of 
expanding facilities, obtaining the necessary refrigeration equipment, 
and retaining quantities of carcasses long enough to chill them to 
40 deg.F before shipping was prohibitive.
    Other commenters said the time and temperature requirements 
conflicted with religious, cultural, and ethnic practices. For example, 
there are ethnic markets for ``hot pork,'' whereby hogs are slaughtered 
and delivered directly to customers for preparation and consumption 
with little or no intervening chilling. A similar process is used with 
lamb, goat, and beef for Moslem customers. Some commenters asserted 
that the proposed requirements also conflict with and preclude the 
Kosher process of ritual salting of poultry.
    Commenters also were concerned that carcasses that are processed in 
one establishment and shipped to another establishment for immediate 
further processing or directly to an off-site cooling facility would 
have to meet carcass cooling requirements.
    Questions were raised about the disposition of products that did 
not meet temperature requirements. Concern was expressed about the 
possible condemnation of large quantities of product based on slight 
deviations from temperature requirements that would not by themselves 
jeopardize food safety.
    A number of commenters addressed the proposed shipping temperature 
requirements. Many asserted that temperature variation during shipping 
is a significant problem. Several commenters asked about their 
liability for product after it has left their custody and is found 
later, e.g., at a warehouse or retail establishment, to have been 
subjected to temperature abuse or other mishandling. Related comments 
stated that time and temperature controls were important at all stages 
of food production, especially at retail, and should be more of a focus 
of FSIS's regulatory oversight.
    A few commenters expressed concern about the burden of preparing a 
written plan and the proposed recordkeeping requirements.
    After reviewing the comments, FSIS agrees that the proposed 
regulations on this issue should not be promulgated at this time. FSIS 
is persuaded that the complexity and variety of acceptable chilling 
practices now in use make the proposed prescriptive time and 
temperature requirements unduly burdensome and impractical. FSIS

[[Page 38857]]

intends to seek an alternative that will not conflict with Kosher or 
other religious, cultural, or ethnic practices that do not present food 
safety hazards to consumers. FSIS has concluded that its food safety 
objectives may be achieved more effectively by regulatory means other 
than those proposed.
    Nevertheless, FSIS continues to believe that prompt, thorough 
chilling of carcasses and raw meat and poultry products by slaughtering 
establishments is necessary to minimize consumers' exposure to 
pathogenic microorganisms. Cooling of carcasses is generally 
acknowledged to be an essential component of any establishment's 
processing controls for safe food production.
    FSIS agrees with those commenters who stated that keeping raw 
products cooled after they leave the establishment, during 
transportation, storage, distribution, and sale to consumers, is 
essential if growth of pathogenic microorganisms on raw products is to 
be prevented. This is consistent with FSIS's farm-to-table food safety 
strategy.
    Instead, FSIS believes that the best way to regulate in this area 
would be by having as a performance standard a maximum temperature for 
products being shipped into commerce, and at which raw products in 
commerce must be maintained. This standard would be applicable to all 
persons who handle such product before the product reaches the 
consumer. FSIS believes that there are at least two possible 
temperatures for this purpose.
    A mandatory temperature of 41 deg.F would provide a large margin of 
safety against the multiplication of pathogenic bacteria, which 
generally will not multiply at temperatures below 50 deg.F. It is 
similar to the maximum temperature of 40 deg.F originally proposed by 
FSIS and recommended in Agriculture Handbook No. 412. It is also the 
same temperature as that specified in the Food and Drug 
Administration's current model Food Code which is offered for adoption 
by States and other government entities with jurisdiction over food 
service, retail food stores and food vending machine operations.
    Alternatively, a temperature of 45 deg.F would still provide a 
margin of safety and also is that required in FDA's current Good 
Manufacturing Regulations for refrigerated foods generally. It also 
would comport with the temperature established for raw product in 
commerce by the European Union. That temperature is increasingly 
accepted as a standard for raw product storage and transportation by 
other countries and appears to be an emerging standard for 
international trade.
    FSIS could supplement the shipping/storage temperature regulations 
with guidelines, including recommended criteria for microorganisms, 
that would provide purchasers and vendors in commerce additional means 
by which to determine whether products bear a level of bacteria 
indicative of temperature abuse and, therefore, are likely to bear 
levels of pathogenic microorganisms that could be associated with 
foodborne illnesses.
    FSIS has concluded that development of such a performance standard 
requires that it obtain additional information and engage in further 
rulemaking. Therefore, FSIS will extend and expand this rulemaking 
proceeding on the issue of cooling raw meat and poultry products. FSIS 
will consider alternatives to the specific time and temperature 
requirements it proposed, including performance standards governing 
cooling during transportation and storage of raw meat and poultry, 
probably in the form of a maximum temperature for transporting and 
holding such product.
    As the next step in its proceedings on this topic, FSIS plans to 
hold a public conference to gather further information on the many 
technical and practical issues raised in the comments as well as on 
possible alternatives to the proposal which will be outlined in the 
Agency's announcement of the conference.

International Trade

    The inspection statutes require that meat and poultry products 
imported into the United States be produced under an inspection system 
equivalent to the U.S. inspection system.
    A large number of commenters requested that FSIS clarify how it 
will determine the ``equivalence'' of foreign inspection systems 
following HACCP implementation. Commenters questioned exactly how FSIS 
will determine foreign system equivalency regarding HACCP systems. 
Further, some commenters asserted that requiring foreign equivalency 
with the U.S. HACCP system could create problems in foreign trade if 
HACCP implementation in the United States causes some foreign 
inspection programs previously designated ``equivalent'' to lose that 
designation.
    Foreign countries with establishments exporting to the United 
States must establish inspection system requirements ``equivalent to'' 
U.S. requirements. This means that all foreign meat and poultry 
establishments that export meat to the United States must operate HACCP 
systems or process control systems ``equivalent to'' HACCP. They must 
also adopt equivalent performance standards.
    The components of FSIS's current import inspection system will not 
change. As part of the evaluation of the laws, policies, and 
administration of the inspection system of any foreign country eligible 
to export meat or poultry products into the United States, FSIS will 
assess the status of HACCP-- or equivalent process control system-
implementation in that country. This assessment will include on-site 
reviews of individual establishments, laboratories, and other 
facilities within the foreign system. The ``equivalency'' of foreign 
inspection will be determined at this stage.
    Further, when these regulations are implemented, the import 
inspection system will continue to include port-of-entry inspection by 
FSIS inspectors to verify the effectiveness of foreign inspection 
systems. All countries exporting raw products to the United States must 
develop and implement performance standards that are equivalent to the 
pathogen reduction performance standards for Salmonella. They must also 
be able to demonstrate that they have systems in place to assure 
compliance with the standards.
    As of January 1, 1995, 1,395 establishments in 36 countries were 
certified to export meat or poultry products to the United States. 
Canada, with 599 establishments; Denmark, with 125; Australia, with 111 
establishments; and New Zealand, with 94 establishments, accounted for 
two-thirds of those, which were collectively the source of 85 percent 
of the 2.6 billion pounds of product imported into the United States 
during 1994. Canada, Denmark, Australia, and New Zealand are currently 
developing HACCP systems.
    Most of the comments concerning the impact on exports dealt with 
the proposed requirement for antimicrobial treatment of U.S. product 
and the proposed exemption for exported product. That proposed 
requirement raised particular concerns because the European Union 
member states and Canada restrict the use of certain antimicrobials on 
meat and poultry carcasses.
    A number of commenters cited the fact that a proposed exemption 
would be ineffective because establishments cannot segregate treated 
product from untreated product. Commenters said this occurs because 
antimicrobial treatments are performed on whole carcasses, while most 
meat and poultry is exported in parts. This condition, the commenters 
argued, would cause

[[Page 38858]]

significant operational difficulty to establishments that were required 
to separate product that had and had not been treated, as well as 
inventory management problems. This requirement might also result in an 
artificial trade barrier with countries such as Canada, which restrict 
use of certain antimicrobial treatments. Suggestions were made that 
FSIS should obtain Codex support and acceptance for the proposed 
antimicrobial interventions as a means to overcome international 
objections to their use. The Agency's decision not to mandate 
antimicrobial treatments largely negates these concerns. FSIS will 
continue to work within Codex and in its bilateral relations with major 
trading partners to ensure that the scientific basis for food safety 
practices in the U.S. are understood and accepted.
    The final rule will affect U.S. exports only if an establishment 
has difficulty meeting the new microbial performance standards without 
using an antimicrobial treatment. FSIS is aware that alternative 
technologies now available can facilitate international trade. For 
example, public comments indicated that trisodium phosphate is approved 
for use in Canada and the United Kingdom, and is being considered by 
the European Union, Australia, and New Zealand. Steam vacuum systems 
constitute an improved technology for establishments exporting beef and 
pork products.

Recordkeeping and Record Retention

    FSIS notes that recordkeeping requirements and record retention 
periods for sanitation SOP's, microbiological testing, and HACCP are 
found in 416.12, 310.25(b)(4), and 381.94(b)(4), and 417.5, 
respectively. The proposed amendments to sections 320.1, 320.3, 
381.175, and 381.177 were intended to continue FSIS' practice of cross-
referencing recordkeeping requirements in Secs. 320.1, 320.3, 381.175, 
and 381.177. FSIS has determined that it is unnecessary to amend these 
sections at this time, especially in view of its ongoing efforts to 
simplify, consolidate, and streamline the meat and poultry inspection 
regulations.

Finished Product Standards for Poultry Carcasses

    FSIS proposed to remove the feces nonconformance specification from 
the poultry finished product standards regulations (Sec. 381.76, Table 
1). That change in the poultry products inspection regulations is being 
effected not in this final rule but in the forthcoming final rule, 
``Enhanced Poultry Inspection; Revision of Finished Product Standards 
with Respect to Fecal Contamination,'' Docket No. 94-016F.

VI. Economic Impact Analysis and Executive Orders

Executive Order 12866

    This rule has been determined to be economically significant and 
was reviewed by OMB under Executive Order 12866.
HACCP-based Regulatory Program Produces Net Benefit to Society
    FSIS has prepared a Final Regulatory Impact Assessment (FRIA) that 
evaluates the costs and benefits of a mandatory HACCP-based program for 
all meat and poultry establishments under inspection. The FRIA 
concludes that mandating HACCP systems will lead to potential benefits 
that far exceed industry implementation and operating costs.
    The 20-year industry costs of implementing the HACCP-based 
regulatory program are estimated to be $968 to $1,156 million. The 20-
year costs to the government are estimated at $56.5 million. FSIS 
estimated that the proposed rule would have 20-year costs of $2.2 
billion dollars. The costs from the Preliminary Regulatory Impact 
Analysis (PRIA) are not directly comparable to costs estimated for the 
final rule. The proposed rule had a larger number of explicit 
regulatory requirements. The PRIA focused on estimating the predictable 
costs of meeting those requirements and included an implicit assumption 
that compliance with the proposed requirements would assure compliance 
with pathogen reduction objectives. In contrast, the final rule allows 
for greater flexibility in meeting the pathogen reduction standards, 
but also outlines a more rigorous enforcement strategy. Thus for the 
FRIA, it was necessary to develop separate cost estimates for the 
potential costs of meeting the new pathogen reduction performance 
standards for Salmonella. Modifications incorporated into the final 
rule have both reduced the total estimated costs and redistributed 
costs in a way that reduces the relative burden on smaller 
establishments.
    Both the preliminary and final analysis identify a potential public 
health benefit of $7.13 to $26.59 billion, tied to eliminating the 
contamination by four pathogens that now occurs in meat and poultry 
establishments. These four pathogens include the three most common 
enteric pathogens of animal origin: Campylobacter jejuni/coli, E. coli 
O157:H7, Salmonella and one environmental pathogen Listeria 
monocytogenes. The potential benefit estimate is tied to the 
minimization of risk from the 90 percent of these pathogens that are 
estimated to contaminate meat and poultry during slaughter and dressing 
procedures. The remaining 10 percent of contamination is estimated to 
occur after the product leaves the manufacturing sector. The link 
between regulatory effectiveness, where effectiveness refers to the 
percentage of pathogens eliminated at the manufacturing stage, and 
health benefits is the assumption that a reduction in pathogens leads 
to a proportional reduction in foodborne illness. The high and low 
range for potential benefits occurs because of the current uncertainty 
in the estimates of the number of cases of foodborne illness and death 
attributable to pathogens that enter the meat and poultry supply at the 
manufacturing stage.
    The benefits analysis in the FRIA concludes that there is 
insufficient knowledge to predict with certainty the effectiveness of 
the rule, where effectiveness refers to the percentage of pathogens 
eliminated at the manufacturing stage. Without specific predictions of 
effectiveness, FSIS has calculated projected health benefits for a 
range of effectiveness levels. For example, if the HACCP-based program 
can reduce the four pathogens by 50 percent and that reduction leads to 
a proportionate reduction in foodborne illness, the projected benefits 
range from $3.6 to $13.3 billion, which is half the potential benefit 
estimate of $7.13 to $26.59 billion.
    If the low potential benefit estimate is correct, the analysis 
shows that the new HACCP-based program must reduce pathogens by 15 to 
17 percent before benefits outweigh projected costs. If the high 
estimate is the correct estimate, the new program needs to reduce 
pathogens by only 4 to 5 percent to generate net societal benefits. 
While there were a large number of comments relating to the 
effectiveness estimates in the PRIA, there were no comments that 
claimed or implied that HACCP would not reduce pathogens at levels 
necessary to produce net societal benefits. The requirements of the 
final rule are organized around the following three components:

     The requirement that all inspected establishments 
develop and implement HACCP programs based on the seven recognized 
principles of HACCP.
     The requirement that all inspected establishments 
develop and implement Sanitation SOP's.
     The requirements that all establishments that slaughter 
cattle, swine, chickens or turkeys implement a microbial sampling

[[Page 38859]]

program using E. coli (generic) as a measure of control of slaughter 
and sanitary dressing procedures and that all establishments that 
slaughter cattle, swine, chickens or turkeys or produce raw ground 
product from these animals or birds meet new pathogen reduction 
performance standards for Salmonella.

    The proposal and final rule can be viewed as two scenarios for 
implementing a mandatory HACCP-based regulatory program. While it's not 
possible to compare the benefits of these two options, the FRIA does 
present a comparison of the costs.
    Table 5 summarizes the estimated costs for both the proposal and 
final rule by individual regulatory component. As mentioned above, the 
costs are not directly comparable because the regulatory components 
have changed. Table 5 shows that all costs have been eliminated for the 
components of time-and-temperature requirements and antimicrobial 
treatments. However, the discussion of potential costs in the FRIA 
recognizes that some establishments may use antimicrobial treatments to 
help meet the pathogen reduction performance standards for Salmonella. 
Other establishments may impose temperature limits to help control 
Salmonella growth.
    Table 5 includes the final cost estimate for generic E. coli 
sampling in slaughter establishments under the regulatory component for 
microbial testing. The costs for required microbial sampling have 
decreased substantially from the proposal.
    In the FRIA, FSIS increased or added a cost estimate for four 
regulatory components. First, based on comments, FSIS added costs for 
recurring training to account for the fact that employee turnover will 
sometimes require establishments to train additional employees. Second, 
FSIS also added a minimal cost for annual reassessment of HACCP plans, 
although the Agency believes that reassessment will be negligible for 
establishments successfully operating HACCP systems. Third, FSIS has 
increased the estimated cost for HACCP plan development. The estimate 
for this cost was increased after reviewing public comments and 
assessing the overall impact on plan development costs of decisions to 
eliminate time-and-temperature and antimicrobial treatment requirements 
prior to HACCP implementation. Finally, the Agency recognizes that some 
establishments will have difficulty meeting the new performance 
standards for Salmonella and that implementing sanitation SOP's and 
HACCP plans will not always assure sufficient pathogen reduction. The 
FRIA has developed two scenarios that lead to low and high cost 
estimates related to potential actions that establishments might 
undertake. Such actions include both process modifications to reduce 
pathogens and the implementation of Salmonella testing programs to 
assure compliance with the new performance standards.
    As shown in Table 5, the two scenarios developed in the FRIA lead 
to a range in cost estimates of $55.5 to $243.5 million to comply with 
the new pathogen reduction standards for Salmonella. The FRIA 
recognizes that the performance criteria for generic E. coli also 
create a set of potential costs for slaughter establishments. A line 
for these costs is shown in Table 5 along with the entry that these 
costs were not separately quantified.
    As discussed in the FRIA, the anticipated actions to comply with 
the generic E. coli criteria are the same as the anticipated actions to 
comply with the standards for Salmonella. FSIS has concluded that if 
the low cost scenario for Salmonella compliance proves to be more 
accurate, than the Agency would expect to see some compliance costs for 
the generic E. coli performance criteria. If the high cost scenario is 
correct, then the compliance actions taken to assure compliance with 
the Salmonella standards should also assure compliance with the generic 
E. coli criteria.

                                Table 5.--Comparison of Costs--Proposal to Final                                
                                  [$ Millions--Present value of 20-year costs]                                  
----------------------------------------------------------------------------------------------------------------
       Regulatory component                       Proposal                                 Final                
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's..............  175.9a................................  171.9                                
II. Time/Temperature Requirements  45.5..................................  0.0                                  
III. Antimicrobial Treatments....  51.7..................................  0.0                                  
IV. Micro Testing................  1,396.3b..............................  174.1                                
V. Compliance With Salmonella      Not Separately Estimatedc.............  55.5-243.5                           
 Standards.                                                                                                     
    Compliance with generic E.     Not Applicable........................  Not Separately Estimated             
     coli criteria.                                                                                             
VI. HACCP                                                                                                       
    Plan Development.............  35.7..................................  54.8                                 
    Annual Plan Reassessment.....  0.0...................................  8.9                                  
    Recordkeeping (Recording,      456.4.................................  440.5d                               
     Reviewing and Storing Data).                                                                               
    Initial Training.............  24.2..................................  22.7d                                
    Recurring Training...........  0.0...................................  22.1e                                
VII. Additional Overtime.........  20.9..................................  17.5d                                
                                  ==============================================================================
      Subtotal--Industry Costs...  2,206.6...............................  968.0-1,156.0                        
VIII. FSIS Costs.................  28.6f.................................  56.5                                 
                                  ------------------------------------------------------------------------------
      Total......................  2,235.2...............................  1,024.5-1,212.5                      
----------------------------------------------------------------------------------------------------------------
a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted  
  because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days  
  after publication.                                                                                            
b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat  
  and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and 
  raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the        
  proposed sampling requirements.                                                                               
c The preliminary analysis accounted for some of the cost of complying with the new standards under the         
  regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.      
d These costs are slightly different from the proposal because of changes in the implementation schedule.       
e FSIS added costs for recurring training based on the review of public comments.                               
f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP    
  verification testing.                                                                                         


[[Page 38860]]


Market Failure Justifies Regulation of Pathogens
    Since all raw meat and poultry products contain microorganisms that 
may be pathogens, raw food unavoidably entails some risk to consumers 
of pathogen-exposure and foodborne illness. The presence and level of 
this risk cannot be determined by a consumer since pathogens are not 
visible to the naked eye. The societal impact of this food safety 
information deficit is a lack of accountability for foodborne illnesses 
caused by pathogenic microorganisms. Consumers often cannot trace a 
transitory illness to any particular food or even be certain it was 
caused by food. Thus, food retailers and restaurateurs are generally 
not held accountable by their customers for selling pathogen-
contaminated products and they, in turn, do not hold their wholesale 
suppliers accountable either.
    This lack of marketplace accountability for foodborne illness means 
that meat and poultry producers and processors have little incentive to 
incur extra costs for more than minimal pathogen controls. The 
widespread lack of information about pathogen sources means that 
business at every level from farm to final sale can market unsafe 
products and not suffer legal consequences or a reduced demand for 
their product.
    The science and technology required to reduce meat and poultry 
pathogens is well established, readily available, and commercially 
practical. FSIS has concluded that the lack of consumer information 
about meat and poultry product safety and the absence of adequate 
incentives for industry to provide more than minimal levels of 
processing safety represents a market failure requiring Federal 
regulatory intervention. The present combination of market regulation 
and industry self-policing has not resolved increasingly apparent 
problems with meat and poultry pathogens. Documented cases of foodborne 
illness each year, some of which have resulted in death, represent a 
public health risk that FSIS has determined to be unacceptable. A 
comprehensive Federal regulatory program is the only means available to 
society for lowering foodborne pathogen risks to an acceptable level. 
FSIS further concludes that a mandatory HACCP regulatory program is the 
only means to attain this goal.
Regulatory Alternatives
    After considering broader regulatory approaches including market 
incentives and voluntary industry standards, FSIS has determined that 
effective process control is needed throughout the meat and poultry 
industry in order to minimize pathogen contamination of food products 
and lower the risk of subsequent foodborne illness.
    FSIS examined the following seven process control approaches before 
determining that mandatory HACCP was the most effective means for 
industry to eliminate pathogens in meat and poultry:
     Status quo
     Intensify present inspection
     Voluntary HACCP regulatory program
     Mandatory HACCP regulation with exemption for small 
businesses
     Mandatory HACCP regulation only for ready-to-eat products
     Modified HACCP--negative records only
     Mandatory HACCP for all establishments
    Each of these seven alternatives was assessed using the following 
five effectiveness factors for process control:
     Controls production safety hazards
     Reduces foodborne illness
     Makes inspection more effective
     Increases consumer confidence
     Provides the opportunity for increased productivity
    Only mandatory HACCP for all establishments was determined to meet 
all five criteria; all of the others were found to be flawed in meeting 
one or more of the target factors.
    The full text of the Final Regulatory Impact Analysis is published 
as a supplement to this document.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act (P.L. 104-4) requires (in Section 
202) that agencies prepare an assessment of anticipated costs and 
benefits before proposing any rule that may result in annual 
expenditures by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000, (adjusted annually for 
inflation). The preliminary and final RIA's fulfill this requirement of 
the Unfunded Mandates Reform Act. FSIS has treated both the proposed 
rule and this final rule as an economically significant regulatory 
action, i.e., annual cost to the private sector of more than 
$100,000,000, under Executive Order 12866 and has prepared a final 
Regulatory Impact Analysis (RIA) in compliance with the provisions of 
Executive Order 12866. The final RIA identifies annual recurring 
private sector costs of from $99.6 to $119.8 million and potential 
annual public health benefits of $.99 to $3.69 billion.
    The Act also requires (in Section 205) that the Agency identify and 
consider a reasonable number of regulatory alternatives and, from these 
alternatives, select the least costly, most cost-effective, or least 
burdensome alternative that achieves the objective of the rule. In the 
final RIA, FSIS considered several broad regulatory alternatives and 
selected the one that is both cost-effective and also the least 
burdensome alternative that achieves the food safety objectives of the 
rule. FSIS concluded that market incentives will not address the public 
health risk resulting from microbial pathogens in meat and poultry, 
primarily because there is rarely feedback to consumers that allows 
more informed purchase decisions nor is there feedback which would 
permit consumers who experience a foodborne illness to routinely, and 
at low cost, seek compensation from responsible parties for losses 
arising from their foodborne illness. Thus, market solutions would not 
adequately address the food safety objectives on the rule. FSIS 
concluded that an industry administered system of voluntary standards 
is likely to be more expensive and less effective than a governmental 
one. Finally, FSIS has recognized that public education is essential 
for assuring food safety, but experience has shown that education alone 
has limited effectiveness in reducing foodborne illness. Thus, while 
consumer education may be cost-effective it would not meet the 
objective of substantially reducing foodborne illness.
    Based on a qualitative analysis of broad regulatory strategies, the 
final RIA concluded that mandatory government standards were needed to 
achieve a solution that is both cost-effective and meets the objective 
of reducing the risk of foodborne illness from meat and poultry. Within 
the framework of a mandatory regulatory program, the final RIA 
discusses several alternatives to a mandatory HACCP-based program for 
all inspected establishments including intensified inspection, 
mandatory HACCP with a small business exemption and mandatory HACCP for 
only ready-to-eat products. These alternatives were evaluated using 
several criteria incorporating the goals of effectiveness, efficiency 
and increased consumer confidence. Using these criteria FSIS concluded 
that HACCP systems designed to meet microbial performance standards 
will be both cost-effective and the least burdensome alternative for 
meeting the foodborne illness reduction objectives of the rule. As the 
final RIA points out, requiring mandatory process control without 
microbial performance

[[Page 38861]]

standards could lead to processes that are well controlled at 
unacceptable pathogen levels. FSIS believes that microbial performance 
standards are necessary to achieve substantial pathogen reduction, 
encourage industry innovation, and provide the impetus for continuing 
improvement and increasing effectiveness.
    Consistent with the requirements in Section 204 to provide 
opportunity for input from State, local and tribal government 
officials, 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 Directors of State meat and poultry 
inspection programs, the meeting included representatives from State 
Departments of Agriculture, State Health Departments and local food 
safety enforcement agencies.
    Also related to the Section 204 requirements, on May 22, 1995 the 
Agency held a public meeting for owners and representatives of small 
meat and poultry establishments and other affected small businesses to 
discuss the pathogen Reduction/HACCP proposal. Three Directors of State 
meat and poultry inspection programs provided comments at the meeting.
    Section 202 of the Act also requires a summary and evaluation of 
comments received from State, local, or tribal governments. There were 
a large number of comments from State and local governments, elected 
members of State legislatures and associations representing State 
programs or businesses within States. Collectively, these comments 
covered most, if not all, of the issues addressed as part of this final 
rule. This preamble and the final RIA represent a summary and 
evaluation of these comments.
    Most of the comments from State, local, or tribal governments 
addressed the potential economic impact on small businesses. The Kansas 
City meeting was intentionally focused on the small business issues. 
Comments from the State program Directors included recommendations for 
various forms of exemptions, voluntary programs or financial assistance 
for small State inspected establishments. The Federal-State-Relations-
Conference included a more focused discussion on the cost to the State 
programs. Attendees stated that FSIS failed to adequately consider the 
cost of the changes to State programs and that FSIS was increasing the 
resource demands for State programs without providing adequate funding.
    There were also written comments stating that the proposed rule was 
an unfunded Federal mandate because of the cost to small establishments 
and the potential impact on State inspection programs. The preliminary 
RIA did not address the impact on State programs. However, FSIS 
recognizes that the 27 States operating their own meat and poultry 
inspection programs will likely have to substantially modify their 
programs after the HACCP/Pathogen Reduction regulation is finalized to 
remain ``at least equal to'' Federal inspection programs as required by 
the FMIA and PPIA. During the regulation's implementation period, FSIS 
will be using the Agency's State-Federal Program resources to assist 
the States in bringing the necessary changes to the State inspection 
programs. Although FSIS has requested some additional funds to 
implement this rule, FSIS has also acknowledged that implementation of 
this rule will require eliminating some tasks, conducting other tasks 
differently and streamlining the organization in order to free up 
resources to fully address the new requirements. FSIS believes that the 
same type of restructuring or reprogramming will take place within the 
State programs. This does guarantee, however, that all States with 
inspection programs will be able to implement the necessary program 
changes without additional funds. FSIS believes, however, that with 
FSIS assistance and with the flexibility provided under the ``equal 
to'' provisions, most of the States should be able to modify their 
programs with minimal additional costs. To the extent that there are 
any additional costs, the State inspection programs are eligible to 
receive up to 50 percent Federal matching funds.

Regulatory Flexibility Act

    The Administrator, FSIS, has determined that this rule will have a 
significant economic impact on a substantial number of small entities. 
This final rule uses two size criteria for providing regulatory 
flexibility for small entities. For livestock and poultry slaughter 
facilities, the microbial sampling requirements vary depending on the 
number of animals or birds slaughtered annually. This will 
significantly reduce the microbial testing costs for smaller 
establishments which, under the proposed rule, would have been required 
to test each species they slaughter every day on which slaughter of 
that species occurred. Under the final rule, establishments that 
annually slaughter fewer 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), 60,000 turkeys or 440,000 chickens (or a 
combination of chickens and turkeys not to exceed 60,000 turkeys or 
440,000 birds total) will not be required to operate microbial sampling 
programs on a continuous basis. Over 78 percent (2,098) of the total 
2,682 slaughter establishments meet these criteria. These 
establishments will be required to annually verify that their slaughter 
and sanitary dressing processes are under control. However, after an 
initial period of sampling in each year, these establishments will be 
required to conduct further sampling in that year only if they make 
major changes to facilities, equipment, and personnel whereby the 
slaughter and dressing process is significantly changed.
    These low-volume establishments will be required to analyze one 
sample per week until they have demonstrated compliance with 
established criteria. At a minimum, low-volume slaughter establishments 
will be required to collect and analyze one sample per week until they 
complete a sampling window (13 samples) annually in order to assess 
whether the performance criteria continue to be met.
    Small slaughter establishments that process only minor species 
(e.g., goats, sheep, ducks, pheasants, etc.) will not be required to 
conduct any sampling. Small slaughter establishments will also face 
less burden because the final rule no longer requires that both cattle 
and swine or chickens and turkeys be sampled in the same establishment, 
i.e., if a low-volume establishment slaughters both cattle and swine or 
turkeys and chickens, it will be required to analyze one sample per 
week from the predominant species until it has demonstrated compliance 
with established criteria. The costs of small slaughter establishments 
are also reduced because the carcass cooling and antimicrobial near-
term requirements have been eliminated from the final rule. Sampling 
frequencies for even the larger slaughter establishments will be based 
on production-volume, thus spreading the cost per pound relatively 
equally among establishments.
    For the purpose of sequencing HACCP implementation FSIS has defined 
a small entity using the Small Business Administration size standard 
for a small meat or poultry manufacturing establishment. That is, all 
establishments with fewer than 500 employees will have additional time 
to implement HACCP. In addition, in

[[Page 38862]]

response to comments that there are hundreds of ``very small'' or 
``micro'' establishments, the Agency will classify an establishment as 
``very small'' if it has either fewer than 10 employees or annual sales 
of less than $2.5 million. This sequencing of HACCP responds to a large 
number of comments requesting that small businesses be given a longer 
period of time to implement HACCP requirements. Many small businesses 
stated they did not want to be exempt, but asked for more flexibility 
in implementing HACCP.
    The FRIA is based on 353 large firms implementing HACCP at 18 
months, 2,941 small firms implementing HACCP at 30 months and 5,785 
very small (2,892 Federal plus 2,893 State) firms implementing HACCP at 
42 months.
    Table 6 illustrates the costs for a small, single-shift, processing 
establishment (no TQC or sanitation PQC program) with two distinct 
production operations other than raw ground product (overall average 
estimated at 2.29 operations per establishment).

    Table 6.--Costs for Typical Single-Shift Processing Establishment   
                                [Dollars]                               
------------------------------------------------------------------------
                                               Development              
                                                   and        Recurring 
                Requirement                  implementation     annual  
                                                  costs         costs   
------------------------------------------------------------------------
Sanitation SOP's...........................            190         1,242
HACCP Plan Development.....................          6,958             0
Annual Plan Reassessment...................              0           102
Training...................................          2,514           251
Recordkeeping..............................              0         6,480
                                            ----------------------------
      Total................................          9,662         8,075
------------------------------------------------------------------------

    If one of the two production operations produced a raw ground 
product, the establishment would have to meet the pathogen reduction 
performance standard for that product. The FRIA points out that raw 
ground operations do not have the same opportunities to reduce 
Salmonella levels as do slaughter establishments. They can control 
growth by avoiding temperature abuse and can limit cross-contamination, 
but basically they must depend on the Salmonella levels of their 
incoming product in order to meet the performance standards. These 
establishments may choose to test incoming product in order to 
eliminate suppliers whose product is found to be positive. The FRIA has 
assumed that the low volume producers would not test incoming 
ingredients.
    Table 7 illustrates the costs for a small, single-shift, 
combination (slaughter and further processing) establishment that 
slaughters cattle or swine, but not both, and has a single further 
processing operation other than ground product. The establishment is 
not under TQC inspection.
    The cost of meeting the pathogen reduction performance standards 
assumes that the establishment will use a hot water antimicrobial rinse 
and have one sample per month analyzed at an outside laboratory ($33.35 
per sample-$400 per year). The average number of head slaughtered in a 
low volume establishment is approximately 5,000 annually. The annual 
cost for the rinse is $400.

   Table 7.--Costs for Typical Single-Shift Combination Establishment   
                                [Dollars]                               
------------------------------------------------------------------------
                                               Development              
                                                   and        Recurring 
                Requirement                  implementation     annual  
                                                  costs         costs   
------------------------------------------------------------------------
Sanitation SOP's...........................            190         1,242
Compliance with Salmonella Standards.......              0           800
E. coli Sampling...........................          1,043           653
HACCP Plan Development.....................          6,958             0
Annual Plan Reassessment...................              0           102
Training...................................          5,028           503
Recordkeeping..............................              0         5,434
                                            ----------------------------
      Total................................         13,219         8,734
------------------------------------------------------------------------

    The development costs for E. coli sampling in the small 
establishment includes $640 for developing a sampling plan and $403 to 
train an individual to conduct aseptic sampling. The recurring costs 
are based on the assumption that an average low volume slaughter 
establishment will have to complete two sampling windows (26 samples) 
before they demonstrate compliance with established criteria.
    The cost of HACCP training has doubled for the combination 
establishment because the FRIA assumed that slaughter and processing 
operations are significantly different, so that the establishment must 
either train two employees or send one employee to two separate 
training courses.
    The HACCP recordkeeping costs (monitoring CCPs and recording 
findings, reviewing records and storing records) in the above two 
examples assume that the establishments are operating each process 
continuously over a standard 52-week, 260-day, 2,080-hour work year. 
Data collected during the preliminary analysis indicates that many low-
volume establishments frequently have only a single production line 
operating at a given time. The final analysis estimates an average 
annual cost for HACCP monitoring and recording of $4,030 for low-volume 
establishments.

Executive Order 12778

    This rule has been reviewed pursuant to Executive Order 12778, 
Civil Justice Reform. States and local jurisdictions are preempted 
under the FMIA and PPIA from imposing any requirements with respect to 
federally inspected premises and facilities, and operations of such 
establishments, that are in addition to, or different from, those 
imposed under the FMIA and PPIA. States and local jurisdictions may, 
however, exercise concurrent jurisdiction over meat and poultry 
products that are outside official establishments for the purpose of 
preventing the distribution of meat or poultry products that are 
misbranded or adulterated under the FMIA or PPIA, or, in the case of 
imported articles, which are not at such an establishment, after their 
entry into the United States. Under the FMIA and PPIA, States that 
maintain meat and poultry inspection programs must impose requirements 
on State-inspected products and establishments that are at least equal 
to those required under the FMIA and the PPIA. These States may, 
however, impose more stringent requirements on such State-inspected 
products and establishments.

Paperwork Requirements

    The paperwork and recordkeeping for this rule are approved under 
OMB number 0583-0103, ``Pathogen Reduction, Hazard Analysis and 
Critical Control Points (HACCP) Systems.'' OMB approved 14,371,901 
annual reporting hours. Overall, the burden hours associated with the 
rule decreased. FSIS determined that the new burden is 8,053,319 hours, 
a 6,318,582-hour reduction. This reduction resulted from the 
elimination of proposed requirements and the adjustment of certain 
burden hour estimations. The following discusses the finalized 
paperwork and recordkeeping requirements and the changes in the burden 
estimations.
Sanitation Standard Operating Procedures (Sanitation SOP's)
    As part of establishments' sanitation requirements, each 
establishment must develop and maintain Sanitation SOP's that must, at 
a minimum, address core

[[Page 38863]]

sanitation procedures. As part of the Sanitation SOP's, establishment 
employees(s) must record results of daily sanitation checks on a 
checklist at the frequencies stated in the Sanitation SOP's. The 
checklist must include both preoperational sanitation checks and 
operational sanitation checks. This checklist must be made available to 
FSIS upon request.
    Agency subject matter experts and private consultants estimate that 
it will take an average of 5, 10, and 25 hours to develop a sanitation 
program for low, medium, and high volume establishments, respectively. 
The burden of documenting the adherence to Sanitation SOP's is based on 
three factors; recording, reviewing, and storage. Recording encompasses 
conducting and inscribing the finding from an observation and filing of 
the document produced. This action is assumed to take 15, 25, and 45 
minutes per day in a low-, medium-, and high- volume establishment, 
respectively. Review of the records generated is estimated to take 5, 
10, and 20 minutes per day for a low-, medium-, and high-volume 
establishment, respectively.
    OMB approved 1,243,622 burden hours for Sanitation SOP's plan 
development, recording and filing, and record review. FSIS determined 
that the burden estimate for these activities was too high. Based on 
more accurate data, FSIS reevaluated the burden estimate and calculated 
the new burden hours to be 1,231,986 hours. This is a 11,636 burden 
hour decrease.
Time and Temperature
    As discussed earlier, the proposed time-and-temperature 
requirements are eliminated. OMB approved 869,156 burden hours for 
time-and-temperature requirements. Therefore, elimination of the time-
and-temperature requirements, results in a 869,156 burden hour 
decrease.
Microbiological Testing
    As part of microbiological testing, each slaughter establishment 
must develop written procedures outlining specimen collection and 
handling. The slaughter establishments will be responsible for entering 
the results into a statistical process control chart or table. The data 
and chart will be available for review by FSIS upon request.
    Agency subject matter experts estimate that it will take 25 hours 
for establishments to develop a microbial sampling and analysis plan. 
It will take an estimated 17.5 minutes to collect samples and 5 minutes 
per sample to enter data into the chart, review, and file the 
information.
    OMB has approved 1,177,924 burden hours for microbial testing plan 
development, sample collection, and data entry by meat and poultry 
establishments. As discussed earlier, the number of meat and poultry 
establishments required by the Pathogen Reduction/HACCP proposal to 
perform microbial testing and the number of tests required decreased. 
FSIS reevaluated this burden estimate and concluded that the burden for 
microbial testing by meat and poultry establishments is 468,061 burden 
hours. Therefore, the burden hour decrease associated with microbial 
testing is 709,863 hours.
HACCP
    Establishments will develop written HACCP plans that include: 
identification of the food safety hazards reasonably likely to occur; 
identification and description of the critical control point for each 
identified hazard; specification of the critical limit that may not be 
exceeded at the CCP; description of the monitoring procedure or device 
to be used; description of the corrective action to be taken if the 
limit is exceeded; description of the records that will be generated 
and maintained regarding this CCP; and description of the establishment 
verification activities and the frequency at which they are to be 
conducted. Performance standards or limits specified in related FSIS 
regulations must be accounted for in the critical limits.
    Establishments will keep records of measurements taken during 
slaughter and processing, corrective actions, verification check 
results, and related activities that contain the identity of the 
product, the product code or slaughter production lot, and the date the 
record was made. The record will be signed by the operator or observer.
    The HACCP records will be reviewed by an establishment employee 
other than the one who produced the record, if practicable, before the 
product is distributed in commerce. If a HACCP-trained individual is 
on-site, that person should be the second reviewer. The reviewer will 
sign the records.
    Although the amount of time to develop a plan for each process 
varies based on its difficulty, Agency subject matter experts estimate 
that low, medium, high volume and state establishments will need an 
average of 136, 126, 113, and 78 hours to develop each plan. There are 
an estimated 7.4 CCP's for each processing plan in Federal 
establishments, 5 CCP's for each slaughter plan in Federal 
establishments, and 5 CCP's for both types of plans in State slaughter 
establishments. The recording and filing is assessed to take 5 minutes 
per CCP and the review should take 2 minutes per CCP.
    OMB approved 11,081,199 burden hours for the maintenance of the 
HACCP-trained individual's resume, plan development, recording, and 
record review. As discussed earlier, FSIS will not require personnel 
resumes to be maintained, thus the burden reported for this activity is 
eliminated. Also, FSIS determined that the burden estimate for plan 
development, recording, and record review was too high. Based on more 
accurate data, FSIS reevaluated the burden estimate and calculated the 
new burden hours to be 6,353,272. This is a 4,727,927 burden hour 
decrease.
    To better illuminate the burden hour changes, the following table 
is provided.

                                        Table 8.--Changes in Burden Hours                                       
----------------------------------------------------------------------------------------------------------------
                                                                   Burden hours                                 
                           Requirement                              approved by     New burden     Reduction in 
                                                                        OMB            hours       burden hours 
----------------------------------------------------------------------------------------------------------------
SOP's for Sanitation............................................       1,243,622       1,231,986          11,636
Time and Temperature............................................         869,156            0.00         869,156
Microbiological Testing.........................................       1,177,924         468,061         709,863
HACCP...........................................................      11,081,199       6,353,272       4,727,927
                                                                 -----------------------------------------------
      Total (Hours).............................................      14,371,901       8,053,319       6,318,582
----------------------------------------------------------------------------------------------------------------


[[Page 38864]]


    The changes in the paperwork and recordkeeping requirements 
contained in this rule have been submitted to the Office of Management 
and Budget for approval under the Paperwork Reduction Act (44 U.S.C. 
3501 et seq.).

VII. Final Rules

List of Subjects

9 CFR Part 304

    Meat inspection.

9 CFR Part 308

    Meat inspection.

9 CFR Part 310

    Meat inspection, Microbial testing.

9 CFR Part 320

    Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 327

    Imports.

9 CFR Part 381

    Poultry and Poultry products, Microbial testing.

9 CFR Part 416

    Sanitation.

9 CFR Part 417

    Hazard Analysis and Critical Control Point (HACCP) Systems.

    For reasons set forth in the preamble, 9 CFR chapter III is amended 
as follows:

PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF 
INSPECTION

    1. The authority citation for part 304 is revised to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    2. Section 304.3 is added to read as follows:


Sec. 304.3   Conditions for receiving inspection.

    (a) Before being granted Federal inspection, an establishment shall 
have developed written sanitation Standard Operating Procedures, as 
required by part 416 of this chapter.
    (b) Before being granted Federal inspection, an establishment shall 
have conducted a hazard analysis and developed and validated a HACCP 
plan, as required by Secs. 417.2 and 417.4 of this chapter. A 
conditional grant of inspection shall be issued for a period not to 
exceed 90 days, during which period the establishment must validate its 
HACCP plan.
    (c) Before producing new product for distribution in commerce, an 
establishment shall have conducted a hazard analysis and developed a 
HACCP plan applicable to that product in accordance with Sec. 417.2 of 
this chapter. During a period not to exceed 90 days after the date the 
new product is produced for distribution in commerce, the establishment 
shall validate its HACCP plan, in accordance with Sec. 417.4 of this 
chapter.

PART 308--SANITATION

    3. The authority citation for part 308 is revised to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    4. Section 308.3 is amended by adding a sentence to the end of 
paragraph (a) to read as follows:


Sec. 308.3   Establishments; sanitary condition; requirements.

    (a) * * *. The provisions of part 416 of this chapter also apply.
* * * * *

PART 310--POST MORTEM INSPECTION

    5. The authority citation for part 310 is revised to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    6. Part 310 is amended by adding a new Sec. 310.25 to read as 
follows:


Sec. 310.25   Contamination with microorganisms; pathogen reduction 
performance standards for Salmonella.

    (a) Criteria for verifying process control; E. coli testing.
    (1) Each official establishment that slaughters cattle and/or hogs 
shall test for Escherichia coli Biotype I (E. coli) and shall:
    (i) Collect samples in accordance with the sampling techniques, 
methodology, and frequency requirements in paragraph (a)(2) of this 
section;
    (ii) Obtain analytic results in accordance with paragraph (a)(3) of 
this section; and
    (iii) Maintain records of such analytic results in accordance with 
paragraph (a)(4) of this section.
    (2) Sampling requirements.
    (i) Written procedures. Each establishment shall prepare written 
specimen collection procedures which shall identify employees 
designated to collect samples, and shall address location(s) of 
sampling, how sampling randomness is achieved, and handling of the 
sample to ensure sample integrity. The written procedure shall be made 
available to FSIS upon request.
    (ii) Sample collection. The establishment shall collect random 
samples from carcasses in the cooler. Samples shall be collected by 
sponging three sites on the selected carcass. On cattle carcasses, 
establishments shall take samples from the flank, brisket, and rump; on 
swine carcasses, establishments shall take samples from the ham, belly, 
and jowl areas. 1
---------------------------------------------------------------------------

    \1\ A copy of FSIS's ``Guidelines for E. coli Testing for 
Process Control verification in Cattle and Swine Slaughter 
Establishments'' is available for inspection in the FSIS Docket 
Room.
---------------------------------------------------------------------------

    (iii) Sampling frequency. Samples shall be taken at a frequency 
proportional to a slaughter establishment's volume of production, at 
the following rates:

Bovines: 1 test per 300 carcasses
Swine: 1 test per 1,000 carcasses

    (iv) Sampling frequency alternatives. An establishment operating 
under a validated HACCP plan in accordance with Sec. 417.2(b) of this 
chapter may substitute an alternative frequency for the frequency of 
sampling required under paragraph (a)(2)(iii) of this section if,
    (A) The alternative is an integral part of the establishment's 
verification procedures for its HACCP plan and,
    (B) 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.
    (v) Sampling in very low volume establishments.
    (A) An establishment annually slaughtering no more than 6,000 
bovines, 20,000 swine, or a combination of bovines and swine not 
exceeding 6,000 bovines and 20,000 animals total, shall collect one 
sample per week starting the first full week of June and continuing 
through August of each year. An establishment slaughtering both species 
shall collect samples from the species it slaughters in larger numbers. 
Weekly samples shall be collected and tested until the establishment 
has completed and recorded one series of 13 tests that meets the 
criteria shown in Table 1 of paragraph (a)(5) of this section.
    (B) Upon the establishment's meeting requirements of paragraph 
(a)(2)(v)(A) of this section, weekly sampling and testing is optional, 
unless changes are made in establishment facilities, equipment, 
personnel or procedures that may affect the adequacy of existing 
process control measures, as determined by the establishment or FSIS. 
FSIS determinations that changes have been made requiring resumption of 
weekly testing shall be provided to the establishment in writing.
    (3) Analysis of samples. Laboratories may use any quantitative 
method for

[[Page 38865]]

analysis of E. coli that is approved by the Association of Official 
Analytic Chemists International 2 or approved 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.
---------------------------------------------------------------------------

    \2\ A copy of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists International,'' 16th 
edition, 1995, is on file with the Director, Office of the Federal 
Register, and may be purchased from the Association of Official 
Analytical Chemists International, Inc., 481 North Frederick Ave., 
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------

    (4) Recording of test results. The establishment shall maintain 
accurate records of all test results, in terms of cfu/cm\2\ of surface 
area sponged. Results shall be recorded onto a process control chart or 
table showing at least the most recent 13 test results, by class of 
livestock slaughtered, permitting evaluation of the laboratory results 
in accordance with the criteria set forth in paragraph (a)(5) of this 
section. Records shall be retained at the establishment for a period of 
12 months and shall be made available to FSIS upon request.
    (5) Criteria for Evaluation of test results. An establishment is 
operating within the criteria when the most recent E. coli test result 
does not exceed the upper limit (M), and the number of samples, if any, 
testing positive at levels above (m) is three or fewer out of the most 
recent 13 samples (n) taken, as follows:

                                  Table 1.--Evaluation of E. coli Test Results                                  
                                                                                                                
                                                                                                       Maximum  
                                                                                         Number of      number  
       Slaughter class           Lower limit of marginal      Upper limit of marginal     samples     permitted 
                                          range                        range               tested    in marginal
                                                                                                        range   
                               (m)........................  (M).......................          (n)          (c)
----------------------------------------------------------------------------------------------------------------
Steers/heifers...............  Negative a.................  100 cfu/cm\2\.............           13            3
Cows/bulls...................  Negative a.................  100 cfu/cm\2\.............           13            3
Market hogs..................  10 cfu/cm\2\...............  10,000 cfu/cm\2\..........           13            3
a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
  at least 5 cfu/cm\2\ carcass surface area.                                                                    

    (6) Failure to meet criteria. Test results that do not meet the 
criteria described in paragraph (a)(5) of this section are an 
indication that the establishment may not be maintaining process 
controls sufficient to prevent fecal contamination. FSIS shall take 
further action as appropriate to ensure that all applicable provisions 
of the law are being met.
    (7) Failure to test and record. Inspection shall be suspended in 
accordance with rules of practice that will be adopted for such 
proceedings upon a finding by FSIS that one or more provisions of 
paragraphs (a) (1)-(4) of this section have not been complied with and 
written notice of same has been provided to the establishment.
    (b) Pathogen reduction performance standard; Salmonella.
    (1) Raw meat product performance standards for Salmonella. An 
establishment's raw meat products, when sampled and tested by FSIS for 
Salmonella, as set forth in this section, may not test positive for 
Salmonella at a rate exceeding the applicable national pathogen 
reduction performance standard, as provided in Table 2:

               Table 2.--Salmonella Performance Standards               
------------------------------------------------------------------------
                                                               Maximum  
                                   Performance                number of 
                                    Standard     Number of    positives 
        Class of product            (percent      samples     to achieve
                                  positive for  tested  (n)    Standard 
                                  Salmonella)a                   (c)    
------------------------------------------------------------------------
Steers/heifers..................          1.0%           82            1
Cows/bulls......................          2.7%           58            2
Ground beef.....................          7.5%           53            5
Hogs............................          8.7%           55            6
Fresh pork sausages.............         bN.A.         N.A.         N.A.
------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national          
  prevalence of Salmonella on the indicated raw product based on data   
  developed by FSIS in its nationwide microbiological data collection   
  programs and surveys. Copies of Reports on FSIS's Nationwide          
  Microbiological Data Collection Programs and Nationwide               
  Microbiological Surveys used in determining the prevalence of         
  Salmonella on raw products are available in the FSIS Docket Room.     
b Not available; values for fresh pork sausage will be added upon       
  completion data collection programs for those products.               

    (2) Enforcement. FSIS will sample and test raw meat products in an 
individual establishment on an unannounced basis to determine 
prevalence of Salmonella in such products to determine compliance with 
the standard. The frequency and timing of such testing will be based on 
the establishment's previous test results and other information 
concerning the establishment's performance. In an establishment 
producing more than one class of product subject to the pathogen 
reduction standard, FSIS may sample any or all such classes of 
products.3
---------------------------------------------------------------------------

    \3\ A copy of FSIS's ``Sample Collection Guidelines and 
Procedure for Isolation and Identification of Salmonella from Meat 
and Poultry Products'' is available for inspection in the FSIS 
Docket Room.
---------------------------------------------------------------------------

    (3) Noncompliance and establishment response. When FSIS determines 
that an

[[Page 38866]]

establishment has not met the performance standard:
    (i) The establishment shall take immediate action to meet the 
standard.
    (ii) If the establishment fails to meet the standard on the next 
series of compliance tests for that product, the establishment shall 
reassess its HACCP plan for that product and take appropriate 
corrective actions.
    (iii) Failure by the establishment to act in accordance with 
paragraph (b)(3)(ii) of this section, or failure to meet the standard 
on the third consecutive series of FSIS-conducted tests for that 
product, constitutes failure to maintain sanitary conditions and 
failure to maintain an adequate HACCP plan, in accordance with part 417 
of this chapter, for that product, and will cause FSIS to suspend 
inspection services. Such suspension will remain in effect until the 
establishment submits to the FSIS Administrator or his/her designee 
satisfactory written assurances detailing the action taken to correct 
the HACCP system and, as appropriate, other measures taken by the 
establishment to reduce the prevalence of pathogens.
    7. The authority citation for part 320 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    8. Section 320.6 is amended by revising paragraph (a) to read as 
follows:


Sec. 320.6   Information and reports required from official 
establishment operators.

    (a) The operator of each official establishment shall furnish to 
Program employees accurate information as to all matters needed by them 
for making their daily reports of the amount of products prepared or 
handled in the departments of the establishment to which they are 
assigned and such reports concerning sanitation, mandatory 
microbiological testing, and other aspects of the operations of the 
establishment and the conduct of inspection, as may be required by the 
Administrator in special cases.
 * * * * *

PART 327--IMPORTED PRODUCTS

    9. The authority citation for Part 327 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    10. Section 327.2 is amended by redesignating paragraphs (a)(2)(i) 
(a)-(g) as (a)(2)(i) (A)-(G), redesignating paragraphs (a)(2)(ii) (a)-
(g) to (a)(2)(ii) (A)-(G), redesignating paragraph (a)(2)(ii)(h) as 
(a)(2)(ii)(I), and by adding a new paragraph (a)(2)(ii)(H) to read as 
set forth below, and by redesignating paragraphs (a)(2)(iv) (a)-(c) as 
(a)(2)(iv) (A)-(C).


Sec. 327.2   Eligibility of foreign countries for importation of 
products into the United States.

 * * * * *
    (a) * * *
    (2) * * *
    (ii) * * *
    (H) A Hazard Analysis and Critical Control Point (HACCP) system, as 
set forth in part 417 of this chapter.
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    11. The authority citation for part 381 is revised to read as 
follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 
2.53.

Subpart D--Application for Inspection; Grant or Refusal of 
Inspection

    12. A new Sec. 381.22 is added to subpart D to read as follows:


Sec. 381.22  Conditions for receiving inspection.

    (a) Before being granted Federal inspection, an establishment shall 
have developed written sanitation Standard Operating Procedures, in 
accordance with Part 416 of this chapter.
    (b) Before being granted Federal inspection, an establishment shall 
have conducted a hazard analysis and developed and validated a HACCP 
plan, in accordance with Secs. 417.2 and 417.4 of this chapter. A 
conditional grant of inspection shall be issued for a period not to 
exceed 90 days, during which period the establishment must validate its 
HACCP plan.
    (c) Before producing new product for distribution in commerce, an 
establishment shall have conducted a hazard analysis and developed a 
HACCP plan applicable to that product in accordance with Sec. 417.2 of 
this chapter. During a period not to exceed 90 days after the date the 
new product is produced for distribution in commerce, the establishment 
shall validate its HACCP plan, in accordance with Sec. 417.4 of this 
chapter.

Subpart H--Sanitation

    13. Section 381.45 is amended to read as follows:


Sec. 381.45  Minimum standards for sanitation, facilities, and 
operating procedures in official establishments.

    The provisions of Secs. 381.46 and 381.61, inclusive, and part 416 
of this chapter shall apply with respect to all official 
establishments.

Subpart K--Post Mortem Inspection: Disposition of Carcasses and 
Parts

    14. Section 381.94 is added to subpart K to read as follows:


Sec. 381.94  Contamination with Microorganisms; process control 
verification criteria and testing; pathogen reduction standards.

    (a) Criteria for verifying process control; E. coli testing.
    (1) Each official establishment that slaughters poultry shall test 
for Escherichia coli Biotype I (E. coli) and shall:
    (i) Collect samples in accordance with the sampling techniques, 
methodology, and frequency requirements in paragraph (a)(2) of this 
section;
    (ii) Obtain analytic results in accordance with paragraph (a)(3) of 
this section; and
    (iii) Maintain records of such analytic results in accordance with 
paragraph (a)(4) of this section.
    (2) Sampling requirements.
    (i) Written procedures. Each establishment shall prepare written 
specimen collection procedures which shall identify employees 
designated to collect samples, and shall address location(s) of 
sampling, how sampling randomness is achieved, and handling of the 
sample to ensure sample integrity. The written procedure shall be made 
available to FSIS upon request.
    (ii) Sample collection. The establishment shall collect random 
samples from carcasses. Carcasses to be sampled will be selected 
randomly. Samples shall be collected by taking a whole bird from the 
end of the chilling process, after the drip line, and rinsing it in an 
amount of buffer appropriate for the type of bird being tested. 1
---------------------------------------------------------------------------

    \1\ A copy of FSIS's guideline, ``Sampling Technique for E. coli 
in Raw Meat and Poultry for Process Control Verification,'' is 
available in the FSIS Docket Room for inspection.
---------------------------------------------------------------------------

    (iii) Sampling frequency. Samples will be taken at a frequency 
proportional to a slaughter establishment's volume of production, at 
the following rates:

Chickens: 1 sample per 22,000 carcasses
Turkeys: 1 sample per 3,000 carcasses

    (iv) Sampling frequency alternatives. An establishment operating 
under a validated HACCP plan in accordance with Sec. 417.2(b) of this 
chapter may substitute an alternative frequency for the frequency of 
sampling required under paragraph (a)(2)(iii) of this section if,
    (A) The alternative is an integral part of the establishment's 
verification procedures for its HACCP plan and,
    (B) FSIS does not determine, and notify the establishment in 
writing, that

[[Page 38867]]

the alternative frequency is inadequate to verify the effectiveness of 
the establishment's processing controls.
    (v) Sampling in very low volume establishments.
    (A) An establishment annually slaughtering no more than 440,000 
chickens, 60,000 turkeys, or a combination of chickens and turkeys not 
exceeding 60,000 turkeys and 440,000 birds total, shall collect one 
sample per week starting the first full week of June through August of 
each year. An establishment slaughtering both chickens and turkeys 
shall collect samples from the species it slaughters in larger numbers. 
Weekly samples shall be collected and tested until the establishment 
has completed and recorded one series of 13 tests that meets the 
criteria shown in Table 1 of paragraph (a)(5) of this section.
    (B) Upon the establishment's meeting the requirements of paragraph 
(a)(2)(v)(A) of this section, weekly sampling and testing is optional, 
unless changes are made in establishment facilities, equipment, 
personnel or procedures that may affect the adequacy of existing 
process control measures, as determined by the establishment or by 
FSIS. FSIS determinations that changes have been made requiring 
resumption of weekly testing shall be provided to the establishment in 
writing.
    (3) Analysis of samples. Laboratories may use any quantitative 
method for analysis of E. coli that is sensitive to 5 or fewer cfu/ml 
of rinse fluid and is approved by the Association of Official Analytic 
Chemists International 2 or approved 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.
---------------------------------------------------------------------------

    \2\ A copy of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists International,'' 16th 
edition, 1995, is on file with the Director, Office of the Federal 
Register, and may be purchased from the Association of Official 
Analytical Chemists International, Inc., 481 North Frederick Ave., 
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------

    (4) Recording of test results. The establishment shall maintain 
accurate records of all test results, in terms of cfu/ml of rinse 
fluid. Results shall be recorded onto a process control chart or table 
showing at least the most recent 13 test results, by kind of poultry 
slaughtered, permitting evaluation of the laboratory results in 
accordance with the criteria set forth in paragraph (a)(5) of this 
section. Records shall be retained at the establishment for a period of 
12 months and shall be made available to FSIS upon request.
    (5) Criteria for Evaluation of test results. An establishment is 
operating within the criteria when the most recent E. coli test result 
does not exceed the upper limit (M), and the number of samples, if any, 
testing positive at levels above (m) is three or fewer out of the most 
recent 13 samples (n) taken, as follows:

                                  Table 1.--Evaluation of E. coli Test Results                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                 Maximum number 
                                        Lower limit of     Upper limit of    Number of sample     permitted in  
           Slaughter class              marginal range     marginal range       tested (n)       marginal range 
                                             (m)                (M)                                   (c)       
----------------------------------------------------------------------------------------------------------------
Broilers............................         100 cfu/ml       1,000 cfu/ml                 13                  3
Turkeys.............................             a N.A.               N.A.               N.A.               N.A.
----------------------------------------------------------------------------------------------------------------
a Not available; values for turkeys will be added upon completion of data collection program for turkeys.       

    (6) Failure to meet criteria. Test results that do not meet the 
criteria described in paragraph (a)(5) of this section are an 
indication that the establishment may not be maintaining process 
controls sufficient to prevent fecal contamination. FSIS shall take 
further action as appropriate to ensure that all applicable provisions 
of the law are being met.
    (7) Failure to test and record. Inspection will be suspended in 
accordance with rules of practice that will be adopted for such 
proceeding, upon a finding by FSIS that one or more provisions of 
paragraphs (a) (1)-(4) of this section have not been complied with and 
written notice of same has been provided to the establishment.
    (b) Pathogen reduction performance standards; Salmonella.
    (1) Raw poultry product performance standards for Salmonella. (i) 
An establishment's raw poultry products, when sampled and tested by 
FSIS for Salmonella as set forth in this section, may not test positive 
for Salmonella at a rate exceeding the applicable national pathogen 
reduction performance standard, as provided in Table 2:

                                   Table 2.--Salmonella Performance Standards                                   
----------------------------------------------------------------------------------------------------------------
                                                            Performance                        Maximum number of
                                                         Standard (percent  Number of samples     positives to  
                    Class of product                        positive for       tested  (n)      achieve Standard
                                                           Salmonella) a                              (c)       
----------------------------------------------------------------------------------------------------------------
Broilers...............................................            b 20.0%                 51                 12
Ground chicken.........................................               44.6                 53                 26
Ground turkey..........................................               49.9                 53                 29
Turkeys................................................             b N.A.               N.A.               N.A.
----------------------------------------------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw    
  products based on data developed by FSIS in its nationwide microbiological baseline data collection programs  
  and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide  
  Microbiological Surveys used in determining the prevalence of Salmonella on raw products are avialable in the 
  FSIS Docket Room.)                                                                                            
b Standard is based on partial analysis of baseline survey data; subject to confirmation upon publication of    
  baseline survey report.                                                                                       
d Not available; baseline targets for turkeys will be added upon completion of the data collection programs for 
  that product.                                                                                                 


[[Page 38868]]


    (2) Enforcement. FSIS will sample and test raw poultry products in 
an individual establishment on an unannounced basis to determine 
prevalence of Salmonella in such products to determine compliance with 
the standard. The frequency and timing of such testing will be based on 
the establishment's previous test results and other information 
concerning the establishment's performance. In an establishment 
producing more than one class of product subject to the pathogen 
reduction standard, FSIS may sample any or all such classes of 
products.3
---------------------------------------------------------------------------

    \3\ A copy of FSIS's ``Sample Collection Guidelines and 
Procedure for Isolation and Identification of Salmonella from Raw 
Meat and Poultry Products'' is available for inspection in the FSIS 
Docket Room.
---------------------------------------------------------------------------

    (3) Noncompliance and establishment response. When FSIS determines 
that an establishment has not met the performance standard:
    (i) The establishment shall take immediate action to meet the 
standard.
    (ii) If the establishment fails to meet the standard on the next 
series of compliance tests for that product, the establishment shall 
reassess its HACCP plan for that product.
    (iii) Failure by the establishment to act in accordance with 
paragraph (b)(3)(ii) of this section, or failure to meet the standard 
on the third consecutive series of FSIS-conducted tests for that 
product, constitutes failure to maintain sanitary conditions and 
failure to maintain an adequate HACCP plan, in accordance with part 417 
of this chapter, for that product, and will cause FSIS to suspend 
inspection services. Such suspension will remain in effect until the 
establishment submits to the FSIS Administrator or his/her designee 
satisfactory written assurances detailing the action taken to correct 
the HACCP system and, as appropriate, other measures taken by the 
establishment to reduce the prevalence of pathogens.

Subpart Q--Records, Registration, and Reports

    15. Section 381.180 is amended by revising paragraph (a) to read as 
follows:


Sec. 381.180  Information and reports required from official 
establishment operators.

    (a) The operator of each official establishment shall furnish to 
Program employees accurate information as to all matters needed by them 
for making their daily reports of the amount of products prepared or 
handled in the departments of the establishment to which they are 
assigned and such reports concerning sanitation, mandatory 
microbiological testing, and other aspects of the operations of the 
establishment and the conduct of inspection thereat, as may be required 
by the Administrator in special cases.
* * * * *

Subpart T--Imported Poultry Products

    16. Section 381.196 is amended by redesignating paragraphs 
(a)(2)(i) (a)-(g) as paragraphs (a)(2)(i) (A)-(G), redesignating 
paragraphs (a)(2)(ii) (a)-(g) to (a)(2)(ii) (A)-(G), redesignating 
paragraph (a)(2)(ii)(h) as (a)(2)(ii)(I), and by adding a new paragraph 
(a)(2)(ii)(H) to read as set forth below, and redesignating paragraphs 
(a)(2)(iv) (a)-(c) as (a)(2)(iv)(A)-(c).


Sec. 381.196  Eligibility of foreign countries for importation of 
products into the United States.

* * * * *
    (a) * * *
    (2) * * *
    (ii) * * *
    (H) A Hazard Analysis and Critical Control Point (HACCP) system, as 
set forth in part 417 of this chapter.
* * * * *
    17. A new subchapter E, consisting of Parts 416 and 417 is added to 
chapter III--Food Safety and Inspection Service, Meat and Poultry 
Inspection, Department of Agriculture to read as follows:
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION 
ACT AND THE POULTRY PRODUCTS INSPECTION ACT

Part

416  Sanitation
417  Hazard Analysis and Critical Control Point (HACCP) Systems

SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT 
INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT

PART 416--SANITATION

Sec.
416.11  General rules.
416.12  Development of sanitation SOP's.
416.13  Implementation of SOP's.
416.14  Maintenance of Sanitation SOP's.
416.15  Corrective Actions.
416.16  Recordkeeping Requirements.
416.17  Agency verification.

    Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 
7 CFR 2.18, 2.53.


Sec. 416.11  General rules.

    Each official establishment shall develop, implement, and maintain 
written standard operating procedures for sanitation (Sanitation SOP's) 
in accordance with the requirements of this part.


Sec. 416.12  Development of Sanitation SOP's.

    (a) The Sanitation SOP's shall describe all procedures an official 
establishment will conduct daily, before and during operations, 
sufficient to prevent direct contamination or adulteration of 
product(s).
    (b) The Sanitation SOP's shall be signed and dated by the 
individual with overall authority on-site or a higher level official of 
the establishment. This signature shall signify that the establishment 
will implement the Sanitation SOP's as specified and will maintain the 
Sanitation SOP's in accordance with the requirements of this part. The 
Sanitation SOP's shall be signed and dated upon initially implementing 
the Sanitation SOP's and upon any modification to the Sanitation SOP's.
    (c) Procedures in the Sanitation SOP's that are to be conducted 
prior to operations shall be identified as such, and shall address, at 
a minimum, the cleaning of food contact surfaces of facilities, 
equipment, and utensils.
    (d) The Sanitation SOP's 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).


Sec. 416.13  Implementation of SOP's.

    (a) Each official establishment shall conduct the pre-operational 
procedures in the Sanitation SOP's before the start of operations.
    (b) Each official establishment shall conduct all other procedures 
in the Sanitation SOP's at the frequencies specified.
    (c) Each official establishment shall monitor daily the 
implementation of the procedures in the Sanitation SOP's.


Sec. 416.14  Maintenance of Sanitation SOP's.

    Each official establishment shall routinely evaluate the 
effectiveness of the Sanitation SOP's and the procedures therein in 
preventing direct contamination or adulteration of product(s) and shall 
revise both as necessary to keep them effective and current with 
respect to changes in facilities, equipment, utensils, operations, or 
personnel.


Sec. 416.15  Corrective Actions.

    (a) Each official establishment shall take appropriate corrective 
action(s) when either the establishment or FSIS determines that the 
establishment's Sanitation SOP's or the procedures specified therein, 
or the implementation or maintenance of the Sanitation SOP's, may have 
failed to prevent direct

[[Page 38869]]

contamination or adulteration of product(s).
    (b) Corrective actions 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 appropriate reevaluation and 
modification of the Sanitation SOP's and the procedures specified 
therein.


Sec. 416.16  Recordkeeping requirements.

    (a) Each official establishment shall maintain daily records 
sufficient to document the implementation and monitoring of the 
Sanitation SOP's and any corrective actions taken. The establishment 
employee(s) specified in the Sanitation SOP's as being responsible for 
the implementation and monitoring of the procedure(s) specified in the 
Sanitation SOP's shall authenticate these records with his or her 
initials and the date.
    (b) Records required by this part may be maintained on computers 
provided the establishment implements appropriate controls to ensure 
the integrity of the electronic data.
    (c) Records required by this part shall be maintained for at least 
6 months and made accesable available to FSIS. All such records shall 
be maintained at the official establishment for 48 hours following 
completion, after which they may be maintained off-site provided such 
records can be made available to FSIS within 24 hours of request.


Sec. 416.17  Agency verification.

    FSIS shall verify the adequacy and effectiveness of the Sanitation 
SOP's and the procedures specified therein by determining that they 
meet the requirements of this part. Such verification may include:
    (a) Reviewing the Sanitation SOP's;
    (b) Reviewing the daily records documenting the implementation of 
the Sanitation SOP's and the procedures specified therein and any 
corrective actions taken or required to be taken;
    (c) Direct observation of the implementation of the Sanitation 
SOP's and the procedures specified therein and any corrective actions 
taken or required to be taken; and
    (d) Direct observation or testing to assess the sanitary conditions 
in the establishment.

PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) 
SYSTEMS

Sec.
417.1  Definitions.
417.2  Hazard analysis and HACCP plan.
417.3  Corrective actions.
417.4  Validation, verification, reassessment.
417.5  Records.
417.6  Inadequate HACCP Systems.
417.7  Training.
417.8  Agency verification.

    Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C. 
1901-1906; 7 CFR 2.18, 2.53.


Sec. 417.1  Definitions.

    For purposes of this part, the following definitions shall apply:
    Corrective action. Procedures to be followed when a deviation 
occurs.
    Critical control point. A point, step, or procedure in a food 
process at which control can be applied and, as a result, a food safety 
hazard can be prevented, eliminated, or reduced to acceptable levels.
    Critical limit. The maximum or minimum value to which a physical, 
biological, or chemical hazard must be controlled at a critical control 
point to prevent, eliminate, or reduce to an acceptable level the 
occurrence of the identified food safety hazard.
    Food safety hazard. Any biological, chemical, or physical property 
that may cause a food to be unsafe for human consumption.
     HACCP System. The HACCP plan in operation, including the HACCP 
plan itself.
    Hazard. SEE Food Safety Hazard.
    Preventive measure. Physical, chemical, or other means that can be 
used to control an identified food safety hazard.
    Process-monitoring instrument. An instrument or device used to 
indicate conditions during processing at a critical control point.
    Responsible establishment official. The individual with overall 
authority on-site or a higher level official of the establishment.


Sec. 417.2  Hazard Analysis and HACCP Plan.

     (a) Hazard analysis. (1) Every official establishment shall 
conduct, or have conducted for it, a hazard analysis to determine the 
food safety hazards reasonably likely to occur in the production 
process and identify the preventive measures the establishment can 
apply to control those hazards. The hazard analysis shall include food 
safety hazards that can occur before, during, and after entry into the 
establishment. A food safety hazard that is reasonably likely to occur 
is 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.
    (2) A flow chart describing the steps of each process and product 
flow in the establishment shall be prepared, and the intended use or 
consumers of the finished product shall be identified.
    (3) Food safety hazards might be expected to arise from the 
following:
    (i) Natural toxins;
    (ii) Microbiological contamination;
    (iii) Chemical contamination;
    (iv) Pesticides;
    (v) Drug residues;
    (vi) Zoonotic diseases;
    (vii) Decomposition;
    (viii) Parasites;
    (ix) Unapproved use of direct or indirect food or color additives; 
and
    (x) Physical hazards.
    (b) The HACCP plan. (1) Every establishment shall develop and 
implement a written HACCP plan covering each product produced by that 
establishment whenever a hazard analysis reveals one or more food 
safety hazards that are reasonably likely to occur, based on the hazard 
analysis conducted in accordance with paragraph (a) of this section, 
including products in the following processing categories:
    (i) Slaughter--all species.
    (ii) Raw product--ground.
    (iii) Raw product--not ground.
    (iv) Thermally processed--commercially sterile.
    (v) Not heat treated--shelf stable.
    (vi) Heat treated--shelf stable.
    (vii) Fully cooked--not shelf stable.
    (viii) Heat treated but not fully cooked--not shelf stable.
    (ix) Product with secondary inhibitors--not shelf stable.
    (2) A single HACCP plan may encompass multiple products within a 
single processing category identified in this paragraph, if the food 
safety hazards, critical control points, critical limits, and 
procedures required to be identified and performed in paragraph (c) of 
this section are essentially the same, provided that any required 
features of the plan that are unique to a specific product are clearly 
delineated in the plan and are observed in practice.
    (3) 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 requirements of part 318, subpart G, or part 381, subpart X, 
of this chapter.
    (c) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List the food safety hazards identified in accordance with 
paragraph (a) of this section, which must be controlled for each 
process.

[[Page 38870]]

    (2) List the critical control points for each of the identified 
food safety hazards, including, as appropriate:
    (i) Critical control points designed to control food safety hazards 
that could be introduced in the establishment, and
    (ii) Critical control points designed to control food safety 
hazards introduced outside the establishment, including food safety 
hazards that occur before, during, and after entry into the 
establishment;
    (3) List the critical limits that must be met at each of the 
critical control points. Critical limits shall, at a minimum, be 
designed to ensure that applicable targets or performance standards 
established by FSIS, and any other requirement set forth in this 
chapter pertaining to the specific process or product, are met;
    (4) List the procedures, and the frequency with which those 
procedures will be performed, that will be used to monitor each of the 
critical control points to ensure compliance with the critical limits;
    (5) Include all corrective actions that have been developed in 
accordance with Sec. 417.3(a) of this part, to be followed in response 
to any deviation from a critical limit at a critical control point; and
    (6) Provide for a recordkeeping system that documents the 
monitoring of the critical control points. The records shall contain 
the actual values and observations obtained during monitoring.
    (7) List the verification procedures, and the frequency with which 
those procedures will be performed, that the establishment will use in 
accordance with Sec. 417.4 of this part.
    (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be 
signed and dated by the responsible establishment individual. This 
signature shall signify that the establishment accepts and will 
implement the HACCP plan.
    (2) The HACCP plan shall be dated and signed:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) At least annually, upon reassessment, as required under 
Sec. 417.4(a)(3) of this part.
    (e) Pursuant to 21 U.S.C. 608 and 621, the failure of an 
establishment to develop and implement a HACCP plan that complies with 
this section, or to operate in accordance with the requirements of this 
part, may render the products produced under those conditions 
adulterated.


Sec. 417.3  Corrective actions.

    (a) The written HACCP plan shall identify the corrective action to 
be followed in response to a deviation from a critical limit. The HACCP 
plan shall describe the corrective action to be taken, and assign 
responsibility for taking corrective action, to ensure:
    (1) The cause of the deviation is identified and eliminated;
    (2) The CCP will be under control after the corrective action is 
taken;
    (3) Measures to prevent recurrence are established; and
    (4) No product that is injurious to health or otherwise adulterated 
as a result of the deviation enters commerce.
    (b) If a deviation not covered by a specified corrective action 
occurs, or if another unforeseen hazard arises, the establishment 
shall:
    (1) Segregate and hold the affected product, at least until the 
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
    (2) Perform a review to determine the acceptability of the affected 
product for distribution;
    (3) Take action, when necessary, with respect to the affected 
product to ensure that no product that is injurious to health or 
otherwise adulterated, as a result of the deviation, enters commerce;
    (4) Perform or obtain reassessment by an individual trained in 
accordance with Sec. 417.7 of this part, to determine whether the newly 
identified deviation or other unforeseen hazard should be incorporated 
into the HACCP plan.
    (c) All corrective actions taken in accordance with this section 
shall be documented in records that are subject to verification in 
accordance with Sec. 417.4(a)(2)(iii) and the recordkeeping 
requirements of Sec. 417.5 of this part.


Sec. 417.4  Validation, Verification, Reassessment.

    (a) Every establishment shall validate the HACCP plan's adequacy in 
controlling the food safety hazards identified during the hazard 
analysis, and shall verify that the plan is being effectively 
implemented.
    (1) Initial validation. Upon completion of the hazard analysis and 
development of the HACCP plan, the establishment shall conduct 
activities designed to determine that the HACCP plan is functioning as 
intended. During this HACCP plan validation period, the establishment 
shall repeatedly test the adequacy of the CCP's, critical limits, 
monitoring and recordkeeping procedures, and corrective actions set 
forth in the HACCP plan. Validation also encompasses reviews of the 
records themselves, routinely generated by the HACCP system, in the 
context of other validation activities.
    (2) Ongoing verification activities. Ongoing verification 
activities include, but are not limited to:
    (i) The calibration of process-monitoring instruments;
    (ii) Direct observations of monitoring activities and corrective 
actions; and
    (iii) The review of records generated and maintained in accordance 
with Sec. 417.5(a)(3) of this part.
    (3) Reassessment of the HACCP plan. Every establishment shall 
reassess the adequacy of the HACCP plan at least annually and whenever 
any changes occur that could affect the hazard analysis or alter the 
HACCP plan. Such 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 
shall be performed by an individual trained in accordance with 
Sec. 417.7 of this part. The HACCP plan shall be modified immediately 
whenever a reassessment reveals that the plan no longer meets the 
requirements of Sec. 417.2(c) of this part.
    (b) Reassessment of the hazard analysis. Any establishment that 
does not have a HACCP plan because a hazard analysis has revealed no 
food safety hazards that are reasonably likely to occur shall reassess 
the adequacy of the hazard analysis whenever a change occurs that could 
reasonably affect whether a food safety hazard exists. Such 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; packaging; finished product distribution 
systems; or, the intended use or consumers of the finished product.


Sec. 417.5  Records.

    (a) The establishment shall maintain the following records 
documenting the establishment's HACCP plan:
    (1) The written hazard analysis prescribed in Sec. 417.2(a) of this 
part, including all supporting documentation;
    (2) The written HACCP plan, including 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.
    (3) Records documenting the monitoring of CCP's and their critical 
limits, including the recording of actual

[[Page 38871]]

times, temperatures, or other quantifiable values, as prescribed in the 
establishment's HACCP plan; the calibration of process-monitoring 
instruments; corrective actions, including all actions taken in 
response to a deviation; verification procedures and results; product 
code(s), product name or identity, or slaughter production lot. Each of 
these records shall include the date the record was made.
    (b) Each entry on a record maintained under the HACCP plan shall be 
made at the time the specific event occurs and include the date and 
time recorded, and shall be signed or initialed by the establishment 
employee making the entry.
    (c) Prior to shipping product, the establishment shall review the 
records associated with the production of that product, documented in 
accordance with this section, to ensure completeness, including the 
determination that all critical limits were met and, if appropriate, 
corrective actions were taken, including the proper disposition of 
product. Where practicable, this review shall be conducted, dated, and 
signed by an individual who did not produce the record(s), preferably 
by someone trained in accordance with Sec. 417.7 of this part, or the 
responsible establishment official.
    (d) Records maintained on computers. The use of records maintained 
on computers is acceptable, provided that appropriate controls are 
implemented to ensure the integrity of the electronic data and 
signatures.
    (e) Record retention. (1) Establishments shall retain all records 
required by paragraph (a)(3) of this section as follows: for slaughter 
activities for at least one year; for refrigerated product, for at 
least one year; for frozen, preserved, or shelf-stable products, for at 
least two years.
    (2) Off-site storage of records required by paragraph (a)(3) of 
this section is permitted after six months, if such records can be 
retrieved and provided, on-site, within 24 hours of an FSIS employee's 
request.
    (f) Official review. All records required by this part and all 
plans and procedures required by this part shall be available for 
official review and copying.


Sec. 417.6  Inadequate HACCP Systems.

    A HACCP system may be found to be inadequate if:
    (a) The HACCP plan in operation does not meet the requirements set 
forth in this part;
    (b) Establishment personnel are not performing tasks specified in 
the HACCP plan;
    (c) The establishment fails to take corrective actions, as required 
by Sec. 417.3 of this part;
    (d) HACCP records are not being maintained as required in 
Sec. 417.5 of this part; or
    (e) Adulterated product is produced or shipped.


Sec. 417.7  Training.

    (a) Only an individual who has met the requirements of paragraph 
(b) of this section, but who need not be an employee of the 
establishment, shall be permitted to perform the following functions:
    (1) Development of the HACCP plan, in accordance with Sec. 417.2(b) 
of this part, which could include adapting a generic model that is 
appropriate for the specific product; and
    (2) Reassessment and modification of the HACCP plan, in accordance 
with Sec. 417.3 of this part.
    (b) The individual performing the functions listed in paragraph (a) 
of this section shall have successfully completed a course of 
instruction in the application of the seven HACCP principles to meat or 
poultry product processing, including a segment on the development of a 
HACCP plan for a specific product and on record review.


Sec. 417.8  Agency verification.

    FSIS will verify the adequacy of the HACCP plan(s) by determining 
that each HACCP plan meets the requirements of this part and all other 
applicable regulations. Such verification may include:
    (a) Reviewing the HACCP plan;
    (b) Reviewing the CCP records;
    (c) Reviewing and determining the adequacy of corrective actions 
taken when a deviation occurs;
    (d) Reviewing the critical limits;
    (e) Reviewing other records pertaining to the HACCP plan or system;
    (f) Direct observation or measurement at a CCP;
    (g) Sample collection and analysis to determine the product meets 
all safety standards; and
    (h) On-site observations and record review.

    Done at Washington, DC, on: July 5, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.

    The following are appendices to the preamble of the Final Rule.

    Note: The following appendices will not appear in the Code of 
Federal Regulations.

Appendix A--Guidelines for Developing a Standard Operating Procedure 
for Sanitation (Sanitation SOP's) in Federally Inspected Meat and 
Poultry Establishments

I. Introduction

    Foodborne illness is a significant public health problem in the 
United States. While data on illness associated with meat and poultry 
products are limited, data from various sources suggest that foodborne 
microbial pathogens may cause up to 7 million cases of illness each 
year, and 7,000 deaths. Of these, nearly 5 million cases of illness and 
more than 4,000 deaths may be associated with meat and poultry 
products.
    FSIS is pursuing a broad and long-term science-based strategy to 
improve the safety of meat and poultry products to better protect 
public health. FSIS is undertaking steps to improve the safety of meat 
and poultry throughout the food production, processing, distribution, 
and marketing chain. The Agency's goal is to reduce the risk to public 
health of consuming meat and poultry products by reducing pathogenic 
microbial contamination. The FSIS strategy relies heavily on building 
the principle of prevention into production processes.
    Sections 308.7, 381.57 and 381.58 of the Meat and Poultry 
Inspection Regulations require that rooms, compartments, equipment, and 
utensils used for processing or handling meat or poultry in a federally 
inspected establishment must be kept clean and in a sanitary condition. 
Establishments are responsible for sanitation of facilities, equipment 
and utensils.
    Sanitation maintains or restores a state of cleanliness, and 
promotes hygiene for the prevention of foodborne illness. Sanitation 
encompasses many areas and functions of an establishment, even when not 
in production. However, there are certain sanitary procedures that must 
be addressed and maintained on a daily basis to prevent direct product 
contamination or adulteration. Good sanitation is essential in these 
areas to maintaining a safe food production process.
    FSIS is requiring meat and poultry establishments to develop and 
implement a written Standard Operating Procedure for sanitation 
(Sanitation SOP's) which addresses these areas. An establishment's 
adherence to its written Sanitation SOP will demonstrate knowledge of 
and commitment to sanitation and production of safe meat and poultry 
products.
    New part 416 to the Meat and Poultry Inspection Regulations 
requires that a written Sanitation SOP contain

[[Page 38872]]

established procedures to be followed routinely to maintain a sanitary 
environment for producing safe and unadulterated food products. Plant 
management must develop a Sanitation SOP that describes daily 
sanitation procedures to be performed by the establishment. A 
designated establishment employee(s) must monitor the Sanitation SOP 
and document adherence to the SOP and any corrective actions taken to 
prevent direct product contamination or adulteration. This written 
documentation must be available to FSIS program employees.
    These FSIS guidelines should help federally inspected meat or 
poultry establishments develop, implement and monitor written 
Sanitation SOPs.
    The Sanitation SOP developed by the establishment must detail daily 
sanitation procedures it will use before (pre-operational sanitation) 
and during (operational sanitation) operation to prevent direct product 
contamination or adulteration. FSIS program employees will verify an 
establishment's adherence to its Sanitation SOP and will take 
appropriate action when there is noncompliance.
    These guidelines, where applicable, are for:
     Livestock Slaughter and/or Processing Establishments
     Poultry Slaughter and/or Processing Establishments
     Import Inspection Establishments
     Identification Warehouses
    The establishment should update the Sanitation SOP to reflect 
changes in equipment and facilities, processes, new technology, or 
designated establishment employees.

II. Pre-operational Sanitation

    Established procedures of pre-operational sanitation must result in 
clean facilities, equipment and utensils prior to starting production. 
Clean facilities, equipment, and utensils are free of any soil, tissue 
debris, chemical or other injurious substance that could contaminate a 
meat or poultry food product. Pre-operational sanitation established 
procedures shall describe the daily, routine sanitary procedures to 
prevent direct product contamination or adulteration. The sanitary 
procedures must include the cleaning of product contact surfaces of 
facilities, equipment and utensils to prevent direct product 
contamination or adulteration. The following additional sanitary 
procedures for pre-operational sanitation might include:
     Descriptions of equipment disassembly, reassembly after 
cleaning, use of acceptable chemicals according to label directions, 
and cleaning techniques.
     The application of sanitizers to product contact surfaces 
after cleaning. Sanitizers are used to reduce or destroy bacteria that 
may have survived the cleaning process.

III. Operational Sanitation

    All federally inspected establishments must describe daily, routine 
sanitary procedures that the establishment will conduct during 
operations to prevent direct product contamination or adulteration. 
Established procedures for operational sanitation must result in a 
sanitary environment for preparing, storing, or handling any meat or 
poultry food product in accordance with sections 308/381 of the Meat 
and Poultry Inspection Regulations. Established procedures during 
operations might include, where applicable:
     Equipment and utensil cleaning--sanitizing--disinfecting 
during production, as appropriate, at breaks, between shifts, and at 
midshift cleanup.
     Employee hygiene: includes personal hygiene, cleanliness 
of outer garments and gloves, hair restraints, hand washing, health, 
etc.
     Product handling in raw and in cooked product areas.
    The established sanitary procedures for operational sanitation will 
vary with the establishment. Establishments with complex processing 
need additional sanitary procedures to ensure a sanitary environment 
and to prevent cross contamination. Establishments that do not 
slaughter or process (such as an Import Inspection facility) should 
develop established sanitary procedures specific to that facility.

IV. Implementing and Monitoring of the Sanitation SOP

    The Sanitation SOP shall identify establishment employee(s) 
(positions rather than specific names of employees) responsible for the 
implementation and maintenance of the Sanitation SOP. Employee(s) are 
to be identified to monitor and evaluate the effectiveness of the 
Sanitation SOP and make corrections when needed. The evaluation can be 
performed by using one or more of the following methods: (1) 
organoleptic (sensory--e.g., sight, feel, smell); (2) chemical (e.g., 
checking the chlorine level); (3) microbiological (e.g., microbial 
swabbing and culturing of product contact surfaces of equipment or 
utensils).
    Establishments might specify the method, frequency, and 
recordkeeping processes associated with monitoring. Pre-operational 
sanitation monitoring should, at a minimum, evaluate and document the 
effective cleaning of all direct product contact facilities, equipment, 
and/or utensils that are to be used at the start of production. 
Operational sanitation monitoring should, at a minimum, document 
adherence to the SOP, including actions that identify and correct 
instances or circumstances of direct product contamination which occur 
from environmental sources (facilities, equipment, pests, etc.) or 
employee practices (personal hygiene, product handling, etc.). All 
establishment records of pre-operational and operational sanitation 
monitoring, including corrective actions to prevent direct product 
contamination or adulteration, must be maintained by the establishment 
for at least six months, and be made available to FSIS program 
employees. After 48 hours, they may be maintained off-site.

V. Corrective Actions

    When deviations occur from the established sanitary procedures 
within the Sanitation SOP, the establishment must take corrective 
actions to prevent direct product contamination or adulteration. 
Instructions should be provided to employees and management officials 
for documenting corrective actions. The actions must be recorded.

Appendix B--Model of a Standard Operating Procedure for Sanitation

    Hill-Top Meats has prepared a written Standard Operating Procedure 
(SOP) for Sanitation. Let's look at the Sanitation SOP and discuss its 
attributes (guidance and advice are inside the boxes).
    Hill-Top Meats, Est. 38, Anytown, U.S.A. is a slaughter and medium 
processing establishment. This plant receives live cattle for slaughter 
and dressing and processes the carcasses into chubs of ground beef, 
roast beef, and ready to eat beef products.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
This introductory information is not a regulatory requirement but       
 identifies the type of establishment and its production. The           
 information will help FSIS personnel, who are not familiar with the    
 establishment, review the Sanitation SOP.                              
------------------------------------------------------------------------

    Management structure is as follows:

President--Joe Doe
Slaughter Manager--Ken Smith
Processing Manager--Susan Jones
Quality Control (QC) Manager--Gwen Summers
Sanitation Manager--Carl Anderson

    The QC Manager is responsible for implementing and daily monitoring 
of the Sanitation SOP and recording the findings and any corrective 
actions. The

[[Page 38873]]

Slaughter, Processing and Sanitation Managers are responsible for 
training and assigning specific duties to other employees and 
monitoring their performance within the Sanitation SOP.
    All records, data, checklists and other information pertaining to 
the Sanitation SOP will be maintained on file and made available to 
FSIS program employees.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
The identification of establishment personnel (positions rather than    
 specific names of employees) responsible for implementing, maintaining,
 monitoring and records associated with the Sanitation SOP is a         
 regulatory requirement. All records pertaining to the Sanitation SOP   
 must be kept on file and made available to FSIS personnel, but it is   
 not necessary to make that statement.                                  
------------------------------------------------------------------------

Sanitation SOP for EST. 38

I. Preoperational Sanitation--Equipment and Facility Cleaning Objective

    All equipment will be cleaned and sanitized prior to starting 
production.
    A. General Equipment Cleaning. (Simple equipment and hand tools are 
cleaned and sanitized in the same manner but they do not require 
disassembly and reassembly.)
    1. Established Sanitary Procedures for Cleaning and Sanitizing 
Equipment:
    a. The equipment is disassembled. Parts are placed in the 
designated tubs, racks, etc.
    b. Product debris is removed.
    c. Equipment parts are rinsed with water to remove remaining 
debris.
    d. An approved cleaner is applied to parts and they are cleaned 
according to manufacturers' directions.
    e. Equipment parts are rinsed with potable water.
    f. Equipment is sanitized with an approved sanitizer, and rinsed 
with potable water if required.
    g. The equipment is reassembled.
    h. The equipment is resanitized with an approved sanitizer, and 
rinsed with potable water if required. 

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
The established sanitary procedures are daily routine sanitary          
 procedures to prevent direct product contamination or adulteration.    
 Daily routine sanitary procedures to prevent direct product            
 contamination or adulteration are required in the Sanitation SOP; FSIS 
 personnel use them to verify compliance with the Sanitation SOP. The   
 procedures shall be specific for each establishment; however, they can 
 be as detailed as the establishment wants to make them.                
------------------------------------------------------------------------

    2. Implementing, Monitoring and Recordkeeping. The QC Manager 
performs daily organoleptic sanitation inspection after preoperational 
equipment cleaning and sanitizing. The results of the inspection are 
recorded on Establishment Form E-1. If everything is acceptable, the 
appropriate box is initialed. If corrective actions are needed, such 
actions are to be documented (see below).
    The QC Manager performs daily microbial monitoring for Total Plate 
Counts (TPCs) after preoperational equipment cleaning and sanitizing. 
The QC Manager swabs one square inch of a food contact surface on a 
piece of equipment or hand tool within one hour prior to production. 
The samples are plated and incubated at 35 deg. C. for 48 hours. 
Colonies are counted and recorded as number of colony forming units 
(CFU) per square inch of surface swabbed. Daily microbial counts are 
documented on Establishment Form M-1.
    3. Corrective Actions.
    a. When the QC Manager determines that the equipment or hand tools 
do not pass organoleptic examination, the cleaning procedure and 
reinspection are repeated. The Sanitation Manager monitors the cleaning 
of the equipment or hand tools and retrains sanitation crew employees, 
if necessary. Corrective actions are recorded on Establishment Form E-
1.
    b. If microbial counts exceed ____ CFUs/sq. in., the QC Manager 
notifies the Sanitation Manager and attempts to determine the cause of 
the high count (for example, cleaning procedures varied, new people 
cleaned the equipment, sanitizer not applied). If microbial counts 
remain high for several days, the QC Manager will confer with the 
Sanitation Manager. The Sanitation Manager notifies sanitation crew 
employees and reviews all cleaning and sanitizing procedures and 
personal hygiene. Microbial counts are recorded on Establishment Form 
M-1. Corrective actions to prevent direct product contamination or 
adulteration are documented on Establishment Form E-1.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
The establishment is required to monitor daily routine sanitation       
 activities as described in the Sanitation SOP, the establishment       
 determines the methods and frequency of monitoring. Microbiological    
 sampling is not required, but Hill-Top Meats wants to monitor the      
 effectiveness of the cleaning by daily microbial sampling, in addition 
 to organoleptic monitoring, and has set limits to enable them to take  
 appropriate action when those limits are exceeded. Establishment Forms 
 E-1 and M-1 are used only as examples; no specific forms or form       
 numbers are required. However, establishments must record the daily    
 completion or adherence to the established procedures in the Sanitation
 SOP, any deviations from regulatory requirements, and corrective       
 actions.                                                               
------------------------------------------------------------------------

    B. Cleaning of Facilities--including floors, walls and ceilings.
    1. Cleaning Procedures.
    a. Debris is swept up and discarded.
    b. Facilities are rinsed with potable water.
    c. Facilities are cleaned with an approved cleaner, according to 
manufacturer's directions.
    d. Facilities are rinsed with potable water.
    2. Cleaning Frequency.
    Floors and walls are cleaned at the end of each production day. 
Ceilings are cleaned as needed, but at least once a week.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
There is no specific requirement to include facility cleaning in the    
 Sanitation SOP, unless part of the facility could directly contaminate 
 or adulterate product.                                                 
------------------------------------------------------------------------

    3. Establishment Monitoring.
    The QC Manager performs daily organoleptic inspection prior to the 
start of operations. Results are recorded on Establishment Form E-1.
    4. Corrective Actions.
    When the QC Manager determines that the facilities do not pass 
organoleptic inspection, the cleaning procedure and reinspection are 
repeated. The Sanitation Manager monitors the cleaning of facilities 
and retrains sanitation crew employees if necessary. Corrective actions 
to prevent direct product contamination or adulteration are recorded on 
Establishment Form E-1.

II. Operational Sanitation

    Objective: Carcass dressing will be performed under sanitary 
conditions and in a manner to prevent contamination of the carcass.
    A. Slaughter Operations.
    1. Established Methods for Carcass Dressing--
    a. Employees will clean hands, arms, gloves, aprons, boots, etc., 
as often as

[[Page 38874]]

necessary during the dressing procedures.
    b. Employees will clean and then sanitize with 180 deg. F. water, 
knives and other hand tools, saws and other equipment, as often as 
necessary during the dressing procedures to prevent contamination of 
the skinned carcass.
    c. The brisket saw is sanitized between carcasses using 180 deg. F. 
water.
    d. Eviscerating employees will maintain clean hands, arms, clothes, 
aprons, boots and knives during the evisceration process. If 
contamination occurs, the employee is required to step away from the 
evisceration table onto a side platform to clean and sanitize apron, 
boots and knives. It may be necessary to clean hands and arms with soap 
and water. In cases of contamination from an abscess or other extensive 
contamination, the employee may need to shower and change clothes 
before resuming work.
    e. The carcass splitting saw is sanitized with 180 deg. F. water 
after each carcass.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
The above methods for carcass dressing are specific for Hill-Top Meats. 
 The establishment considers them to be Good Manufacturing Practices for
 their type of operation, to prevent direct contamination or            
 adulteration of carcasses. Each establishment determines the sanitary  
 procedures and any requirements they want to detail in their Sanitation
 SOP.                                                                   
------------------------------------------------------------------------

    2. Monitoring and Recordkeeping.
    a. The Slaughter Manager is responsible for ensuring that employee 
hygiene practices, sanitary conditions and cleaning procedures are 
maintained during a production shift. The QC Manager monitors the 
sanitation procedures twice during a production shift. Results are 
recorded on Establishment Form E-1.
    b. A Microbiological Control and Monitoring Program is used to 
determine the level of bacteria on product contact surfaces of 
equipment (e.g., knives, hand tools, evisceration table, etc.) and 
outer garments (such as aprons and gloves) during production. The QC 
Manager performs daily microbial monitoring for Total Plate Counts 
(TPCs). The samples are plated and incubated at 35 deg.C. for 48 hours. 
Colonies are counted and recorded as number of colony forming units 
(CFU) per square inch of surface swabbed. Daily microbial counts are 
documented on Establishment Form M-1.
    3. Corrective Actions.
    a. When equipment is visibly contaminated, contaminants are removed 
by cleaning and sanitizing equipment prior to resuming production. The 
Slaughter Manager attempts to determine the cause of the contamination 
and takes corrective action. This may require adjusting equipment, 
retraining employees, temporarily stopping or slowing the line speed, 
etc. Corrective actions are recorded on Establishment Form E-1.
    b. If microbial counts from equipment swabbing exceed the action 
level set, the QC Manager notifies the Slaughter Manager. The Slaughter 
Manager attempts to determine the cause (for example, new people not 
adequately trained, equipment not adjusted properly) and takes 
corrective action. If microbial counts remain above established limits 
for several days, the QC Manager confers with the Slaughter Manager and 
all slaughter operations are reviewed. The Slaughter Manager notifies 
the slaughter employees and reviews personal hygiene, equipment 
adjustment, and sanitary handling procedures. Corrective actions to 
prevent direct product contamination or adulteration are recorded on 
Establishment Form E-1.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
The establishment is required to monitor the regulatory daily sanitation
 activities as described in its Sanitation SOP, but each establishment  
 determines its own methods for monitoring, the frequency of monitoring,
 and the corrective actions to include in the Sanitation SOP. Records   
 must be kept on daily completion of the established procedures,        
 deviations, and corrective actions.                                    
------------------------------------------------------------------------

    B. Processing Operations.
    Objective: Processing is performed under sanitary conditions to 
prevent direct and cross contamination of food products.
    1. Established Sanitary Procedures for Processing--
    a. Employees clean and sanitize hands, gloves, knives, wizard 
knives, other hand tools, cutting boards, etc., as necessary during 
processing to prevent contamination of food products.
    b. All equipment, belt conveyors, tables, and other product contact 
surfaces are cleaned and sanitized throughout the day as needed.
    c. Employees take appropriate precautions when going from a raw 
product area to a cooked product area, to prevent cross contamination 
of cooked products. Employees change outer garments, wash hands and 
sanitize hands with an approved hand sanitizer (sanitizer is equivalent 
to 50 ppm chlorine), put on clean gloves for that room and step into a 
boot sanitizing bath on leaving and entering the respective rooms.
    d. Raw and cooked processing areas are separate. There is no cross 
utilization of equipment between raw and cooked products.
    e. Outer garments, such as aprons, smocks and gloves, are 
identified and designated specifically for either the raw processing 
rooms or the cooked processing rooms. Blue is designated for raw 
processing rooms and orange for cooked processing rooms. The outer 
garments are hung in designated locations when an employee leaves each 
room. Outer garments are maintained in a clean and sanitary manner and 
are changed at least daily and, if necessary, more often.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
Establishments with processing will determine their own established     
 sanitary procedures in the Sanitation SOP and any establishment        
 requirements. Hill-Top Meats considers its established procedures for  
 processing to be Good Manufacturing Practices.                         
------------------------------------------------------------------------

    2. Monitoring and Recordkeeping.
    a. The Processing Manager is responsible for ensuring that employee 
hygiene practices, employee and product traffic patterns, sanitary 
product handling procedures, and cleaning procedures are maintained 
during a production shift. The QC Manager monitors the sanitation 
procedures twice during a production shift. Results are recorded on 
Establishment Form P-1.
    b. A Microbiological Control and Monitoring Program is used to 
determine and control the level of bacteria on both raw and cooked 
product contact surfaces during production. Once a day, the QC Manager 
performs Microbial Monitoring for Total Plate Counts (TPCs). The QC 
Manager swabs one square inch on a product contact surface from each of 
three randomly selected pieces of equipment in each raw product room 
and cooked product room.

    Note: The samples are taken from the cooked product rooms first 
and then from the raw product rooms. The samples are plated and 
incubated at 35 deg. C. for 48 hours. Colonies are counted and 
recorded as number of colony forming units (CFU) per square inch of 
surface swabbed. Microbial counts are documented on Establishment 
Form M-1.

    3. Corrective Actions.
    a. When the QC Manager identifies sanitation problems, the QC 
Manager notifies the Processing Manager. The Processing Manager stops 
production, if necessary, and notifies processing employees to take 
appropriate action to correct the sanitation problems. If necessary, 
processing employees are retrained. Corrective actions are recorded on 
Establishment Form P-1.

[[Page 38875]]

    If microbial counts exceed the action level set for each piece of 
equipment for the specific product in that production line, the QC 
Manager notifies the Processing Manager. The Processing Manager 
attempts to determine the cause (for example, new people going back and 
forth between the raw and cooked rooms, gloves not being changed 
regularly) and takes corrective action. Additional daily microbial 
sampling is done on any equipment that showed high microbial counts, 
until the counts fall below the action level. If microbial counts 
remain high for several days, the QC Manager confers with the 
Processing Manager and Sanitation Manager to review all operations that 
impact that equipment. The Processing Manager notifies the processing 
employees and reviews personal hygiene and sanitary product handling 
procedures. Corrective actions are recorded on Establishment Form P-1.

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
The monitoring and corrective actions are specific for Hill-Top Meats   
 only. Microbial sampling and monitoring are not required for product   
 contact surfaces. Each establishment determines its own procedures for 
 monitoring and the frequency of monitoring to include in its Sanitation
 SOP.                                                                   
------------------------------------------------------------------------

Appendix C--Guidebook for the Preparation of HACCP Plans

Preface

    The Hazard Analysis Critical Control Points (HACCP) system is a 
logical, scientific system that can control safety problems in food 
production. HACCP is now being adopted worldwide. It works with any 
type of food production system and with any food. It works by 
controlling food safety hazards throughout the process. The hazards can 
be biological, chemical, or physical.
    This guidebook was developed to help meat and poultry 
establishments prepare HACCP plans. The steps to developing a HACCP 
plan can be used by all establishments, large or small, complex or 
simple. The guidebook identifies additional sources of information, so 
that small operators won't have to ``go it alone.''
    The forms shown in this guidebook are examples only. Think of this 
as a self-help guide or a do-it-yourself manual. There are many ways to 
get to the final product--a good HACCP plan. So, choose the examples 
that work best in your establishment.
    The guidebook can be used to complement HACCP training. You may 
also wish to use it in conjunction with a video about HACCP. The 
guidebook will provide the basics. When you are ready to move on, there 
are more specialized documents. FSIS is also publishing the Meat and 
Poultry Products Hazards and Controls Guide. It explains in detail the 
biological, chemical, and physical hazards that can occur at different 
steps of meat and poultry slaughter and processing and provides some 
examples of controls for those hazards. In addition, there will be a 
series of Generic Models for different meat and poultry processes, to 
be used as examples. You will probably want to look at the models for 
processes that you use in your establishment. There will be model plans 
for the following 13 processes:

Raw, Ground
Raw, Other
All Other Shelf-Stable, Heat Treated
Fully Cooked, Non-Shelf Stable
All Other Shelf-Stable, Not Heat Treated
All Non-Shelf Stable, Heat Treated, Not Fully Cooked
Non-Shelf Stable with Secondary Inhibitors
Thermally Processed/Commercially Sterile
Swine Slaughter
Poultry Slaughter
Beef Slaughter
Irradiation
Mechanically Separated Species

Developing a HACCP Plan

    The Hazard Analysis and Critical Control Points (HACCP) System is a 
logical, scientific approach to controlling safety problems in food 
production. When a company adopts HACCP, it puts controls in place at 
each point in the production system where safety problems could occur 
from biological, chemical, or physical hazards. To start a HACCP 
system, a company must first write a HACCP plan. This guidebook 
explains how to write a HACCP plan in five preparatory steps and then 
the seven HACCP principles.
    The five ``pre-HACCP'' steps in this guidebook are:
    1. Bring together your HACCP resources.
    2. Describe the product and its method of distribution.
    3. Develop a complete list of ingredients and raw materials used in 
the product.
    4. Develop a process flow diagram.
    5. Meet the regulatory requirements for Sanitation Standard 
Operating Procedures (SOPs).
    Applying the seven HACCP principles makes up the major steps to 
writing a HACCP plan. They are:
    1. Conduct a hazard analysis.
    2. Identify critical control points.
    3. Establish critical limits for each critical control point.
    4. Establish monitoring procedures.
    5. Establish corrective actions.
    6. Establish recordkeeping procedures.
    7. Establish verification procedures.
    As you read this guidebook and look at the examples, the process 
for writing a HACCP plan should become clearer. This first section of 
the guidebook explains the five ``pre-HACCP'' steps. The next seven 
sections cover each of the HACCP principles that you will need to 
follow to develop a HACCP plan.

Pre-HACCP Step 1--Bring Together Your HACCP Resources

    The first step is to assemble your HACCP resources. When a company 
develops a HACCP plan, it is important to bring as much knowledge to 
the table as possible. Actually, you probably have access to more HACCP 
resources than you think! With a small establishment, this might mean 
bringing together one or two employees, one of whom has had HACCP 
training. Your HACCP resources may include outside expertise. You can 
get this expertise through your local Extension Office, a trade or 
professional association, or a contractor of your choice. A larger 
plant may wish to bring in employees from a number of departments, such 
as production, sanitation, quality control, and engineering, as well as 
employees directly involved in daily processing activities. There is no 
magic number of employees needed to write a HACCP plan. It could be one 
employee or, in a very large company, it could be seven or eight 
people.
    Your employee or employees writing the HACCP plan should understand 
some basic things about your establishment: The technology and 
equipment used in your processing lines; the practical aspects of food 
operations; and the flow of the process in your plant. It will be a 
bonus for your HACCP plan if those employees have some knowledge of the 
applied aspects of food microbiology and of HACCP principles and 
techniques, although this knowledge can be supplemented by outside 
experts.

Pre-HACCP Step 2--Describe the Product and Its Method of Distribution

    The second step is to describe completely each food product that 
your plant makes. This will help identify hazards that may exist either 
in the ingredients or in the packaging materials.
    To describe your product, you might ask the following questions 
about the product:
    1. Common name?

[[Page 38876]]

    For example, a cooked sausage could be called franks/hot dogs/
wieners.
    2. How is it to be used?
    Categories might include: Ready-to-eat, to be heated prior to 
consumption, or for further processing.
    3. The type of package?
    For example, is it modified atmosphere packaging?
    4. Length of shelf life?
    In the cooked sausage example, the length of shelf life might be 30 
to 50 days for modified atmospheric packaging.
    5. Where will it be sold?
    For example, will it be sold to wholesale, retail or institutions?
    6. Labeling instructions?
    ``Keep Refrigerated'' would be a common labeling instruction for 
meat and poultry products.
    7. Is special distribution control needed?
    For instance, should the product be kept refrigerated at or below 
40 deg.F? Below is a blank Product Description Form. It is an example. 
You may take it and tailor it to your own establishment.
    Below is an example of a Product Description Form filled in for 
cooked sausage. The HACCP Generic Models developed for 13 different 
processes will give you more samples of product descriptions.

Pre-HACCP Step 3--Develop a Complete List of Ingredients and Raw 
Materials

    The third step is to develop a written list of ingredients and raw 
materials for each process/product. You can write this on a very simple 
form, as shown below. You may wish to divide the ingredients into just 
two categories: Meat (meat such as boneless beef or chicken parts with 
skin) and Other Ingredients (such as spices and preservatives). Below 
is a sample Product and Ingredients Form for chunked and formed, 
breaded chicken patties. Again, these forms are only examples to get 
you started. You may wish to have more elaborate forms for your 
establishment. The important thing is to list all ingredients that go 
into each product!

Pre-HACCP Step 4--Develop a Process Flow Diagram

    The next step is to construct a process flow diagram that 
identifies all the steps used to prepare the product, from receiving 
through final shipment. The diagram should not be so complex that it is 
difficult to follow and understand, but must be complete from the 
beginning of your process to the end.
    You will want to verify the process flow diagram. You do this by 
actually walking through the plant to make sure that the steps listed 
on the diagram describe what really occurs in producing the product.
    A blank process flow diagram is shown below. It is a very simple 
form on which you may want to draw the flow freehand. If you have a 
computer, you can make a fancier form, with arrows leading from step to 
step.

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    An example of a Process Flow Diagram for cooked sausage is shown 
below. The employees in this case chose to construct a flow diagram for 
the meat and poultry ingredients, another one for the non-meat 
ingredients, and a third flow diagram for supplies such as packaging 
materials. You will find more examples of process flow diagrams for 
specific products in the HACCP Generic Models.
    Remember, the purpose of this diagram is to find any places in your 
specific establishment where hazards could occur. As with all HACCP 
planning forms, the approving employee should sign and date the form, 
for your records.

Pre-HACCP Step 5--Meet the Regulatory Requirements for Sanitation 
Standard Operating Procedures

    Good sanitation is one of the most basic ways to ensure that you 
produce safe products. Maintaining good sanitation serves as an 
excellent and necessary foundation for building your HACCP plan. It 
also demonstrates that you have the commitment and resources to 
successfully implement your HACCP plan. Because it is so important, 
meeting the regulatory requirements for Sanitation Standard Operating 
Procedures (SOPs) is a pre-HACCP requirement that must be carried out 
in all establishments. A separate guide and a model Sanitation SOP have 
been prepared and are available to help you with this activity.
    Now you are ready to apply the seven principles that will produce a 
HACCP plan suited to your plant and your products. Those principles and 
how to carry them out will be discussed in detail in the next seven 
sections of this guidebook.


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Principle 1--Conduct a Hazard Analysis

    HACCP Principle No. 1 states:
    ``Conduct a hazard analysis. Prepare a list of steps in the process 
where significant hazards occur and describe the preventive measures.''
    The regulation defines a food safety hazard as ``Any biological, 
chemical, or physical property that may cause a food to be unsafe for 
human consumption.''
    This section will define the hazards and discuss in general where 
they may occur in meat and poultry production. It will then talk about 
identifying hazards in your establishment.
    Finally, this section will explain how you can apply preventive 
measures to the hazards you have identified, to ensure that the 
products are safe for consumers. A preventive measure is defined, in 
the regulation, as ``Physical, chemical, or other means that can be 
used to control an identified food safety hazard.''
    You will find a far more detailed listing of and discussion of 
hazards in the Meat and Poultry Products Hazards and Controls Guide. 
The generic HACCP models discuss the hazards specific to various meat 
and poultry processes, such as raw, ground product or swine slaughter. 
In addition, the References section of this guidebook lists 
publications which can help you identify hazards.
    To identify biological, chemical, or physical hazards likely to 
occur, you need to know about the chemical, physical, and 
microbiological characteristics of meat, poultry, and other 
ingredients, as well as how various processes affect those 
characteristics. You also need to understand the interactions among 
ingredients.
    You need to evaluate each step in the process flow diagram to 
determine whether a biological, chemical and/or physical hazard may be 
introduced at that step and whether preventive measures are available.

Biological Hazards

    Biological hazards are living organisms, including microorganisms, 
that can put human health at risk. Biological hazards include bacteria, 
parasites, protozoa, viruses, and the like.
    Agricultural products and food animals carry a wide range of 
bacteria. From a public health standpoint, most bacteria are harmless. 
Others--the pathogenic microorganisms--can cause illness or even death 
in humans. The numbers and types of bacteria vary from one food or 
animal species to another, from one geographic region to another, and 
with production and slaughter or harvesting methods. During production, 
processing, packaging, transportation, preparation, storage and 
service, any food may be exposed to bacterial contamination. The most 
common biological hazards in meat and poultry are microbiological.
    Some of the major pathogenic bacterial organisms that can cause 
foodborne illness from eating meat or poultry are: Salmonella, 
Clostridium perfringens, Listeria monocytogenes, Staphylococcus aureus, 
Campylobacter jejuni, Yersinia enterocolitica, Bacillus cereus, 
Clostridium botulinum, and Escherichia coli O157:H7.
    In the Meat and Poultry Products Hazards and Controls Guide, you 
will find a brief description of the major microorganisms of concern in 
meat and poultry. Table 1 in that guide describes the temperature and 
pH ranges and the minimum water activity needed for each organism to 
grow. Table 4 lists some preventive measures for biological hazards. To 
thoroughly identify significant biological hazards in your 
establishment, you need to evaluate each specific ingredient and 
processing step in your operation.

Chemical Hazards

    Chemical hazards may also cause foodborne illnesses.
    Chemical hazards fall into two categories:
    1. Naturally occurring poisons or deleterious substances are those 
that are natural constituents of foods and are not the result of 
environmental, agricultural, industrial, or other contamination. 
Examples include aflatoxins, mycotoxins, and shellfish toxins.
    2. Added poisonous or deleterious substances are those which are 
intentionally or unintentionally added to foods at some point in 
growing, harvesting, storage, processing, packing, or distribution. 
This group of chemicals can include pesticides, fungicides, 
insecticides, fertilizers, and antibiotics, as well as direct and 
indirect food additives. This group can also include chemicals such as 
lubricants, cleaners, paints, and coatings.
    To identify any chemical hazards, you first need to identify any 
chemical residues that might be in the animal. To do this, think about 
the following:
     The types of drugs and pesticides routinely used in 
raising the animals which are the source of your meat and poultry 
ingredients.
     Feeds and supplements fed to the animals.
     Environmental contaminants the animals may have come into 
contact with. This includes both naturally occurring contaminants and 
added contaminants.
     Pesticides used on plants that may end up as residues in 
the animal.
     The source of the water the animals were allowed to drink. 
You can use the following preventive measures to help ensure that 
animals entering your establishment are free of harmful residues:
     Require that the animals have been raised in conjunction 
with the January 1994 FDA Compliance Policy Guidelines.
     Require written assurances from suppliers for each lot of 
animals, stating that the animals are free of illegal residues.
     Set your own maximum allowable residue limits for specific 
drugs, pesticides, and environmental contaminants in animal urine or 
tissues as targets to ensure that FDA and EPA tolerances are met.
     Ensure that trucks used to ship the animals do not have 
chemical hazards that could contaminate the animals.
    Most establishments use chemicals during processing and to keep 
their operations sanitary. Yet you need to be aware that chemical 
hazards can occur at any of the following points:
     Prior to receiving chemicals at your establishment.
     Upon receiving chemicals.
     At any point where a chemical is used during processing.
     During storage of chemicals.
     During the use of any cleaning agents, sanitizers, 
lubricants, or other maintenance chemicals.
     Prior to shipment of the finished product.
     In trucks used to ship finished product.
    Some of the measures you can use to prevent chemical hazards are:
     Use only approved chemicals.
     Have detailed product specifications for chemicals 
entering your plant.
     Maintain letters of guarantee from suppliers.
     Inspect trucks used to ship finished product.
     Properly label and store all chemicals.
     Properly train employees who handle chemicals.
    In the Meat and Poultry Products Hazards and Controls Guide, Table 
5 lists some preventive measures for chemical hazards. For still more 
information, see the publication HACCP--Establishing Hazard Analysis 
Critical Control Point Program, Food Processors Institute, 1993.

[[Page 38885]]

Physical Hazards

    A physical hazard is any physical material not normally found in a 
food which causes illness or injury to the individual using the 
product. Physical hazards include a variety of foreign materials or 
objects, such as glass, metal, and plastic. However, foreign objects 
which cannot cause illness or injury are not hazards, even though they 
may not be aesthetically pleasing to your customers.
    A number of situations can result in physical hazards in finished 
products. They include, but are not limited to:
     Contaminated raw materials.
     Poorly designed or poorly maintained facilities and 
equipment. An example would be rust particles and paint chips falling 
from overhead structures onto exposed product.
     Improper procedures or improper employee training and 
practices. For example, by using the wrong cutting technique during the 
cut-up/prefabrication process, employees could cut off and leave pieces 
of their rubber gloves in the product.
    Measures you can take to prevent physical hazards include, but are 
not limited to:
     Make sure your plant specifications for building design 
and operation are accurate and updated regularly.
     Make sure your letters of guarantee for ingredients and 
product supplies are accurate and updated regularly.
     Perform random visual examinations of incoming product and 
materials.
     Use magnets and metal detectors to help find metal 
fragments that would be a physical hazard.
     Use stone traps and bone separators to remove these 
potential physical hazards.
     Keep equipment well maintained.
     Train employees to identify potential problems.
    To identify some preventive measures for physical hazards, see 
Table 6 in the Meat and Poultry Products Hazards and Controls Guide.

Conducting a Hazard Analysis

    Now that you have some understanding of the types of hazards that 
can occur and how to identify and prevent them, you are ready to 
conduct a hazard analysis for each process or product covered in your 
HACCP plan.
    A hazard analysis is the identification of any hazardous 
biological, chemical, or physical properties in raw materials and 
processing steps, and an assessment of their likely occurrence and 
potential to cause food to be unsafe for consumption.
    Your hazard analysis needs to be very specific to your 
establishment and how you make your product, since hazards may vary 
greatly from one establishment to another. This is due to differences 
in: sources of ingredients, product formulations, processing equipment, 
processing methods, duration of the processes and storage, and employee 
experiences, knowledge, and attitudes.
    You also need to review--and perhaps revise--your hazard analysis 
whenever you make any changes in: raw materials suppliers, product 
formulation, preparation procedures, processing steps, packaging 
materials or procedures, distribution or intended use of the product.
    Below is a blank Hazard Identification/Preventive Measures form 
that you may wish to use for your hazard analysis. Below is an example 
of that form filled in for hazards that might exist in a specific 
establishment's ground beef process. The form contains space for the 
process step in which the hazards could occur, the specific hazards, 
and preventive measures to keep that hazard from occurring. Remember, 
HACCP is a preventive system.

Steps in Conducting a Hazard Analysis

    To conduct a hazard analysis, you need to do the following:
First--Evaluate Your Operation for Hazards
    1. Review the product description developed in Pre-HACCP Step 2 and 
determine how this information could influence your hazard analysis.
    2. Look at all product ingredients and incoming materials for the 
product. You developed this list in Pre-HACCP Step 3.
    3. For each processing step identified in the process flow diagram, 
determine if a biological, chemical or physical hazard(s) could exist 
at that step.

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    4. To help identify hazards, you can ask the following questions at 
each processing step:
    Could contaminants reach the product during this processing step? 
Possibilities include: worker handling, contaminated equipment or 
materials, cross-contamination from raw materials, leaking valves or 
pipes, dead ends, splashing, etc.
    Could any pathogens multiply during this process step to the point 
where they became a hazard? Consider product temperature, hold time, 
etc.
    Could this step create a situation where an ingredient, work in 
process, or finished product became contaminated with pathogens?
    Could this step introduce a chemical hazard into the product?
    Could this step introduce a physical hazard into the product?
    5. Fully describe the hazards identified for each step.
    6. For each incoming ingredient and material, indicate if a 
biological, chemical and/or physical hazard exists.
    7. To help identify hazards, you can ask the following questions 
about each ingredient:
    Could this ingredient contain any pathogenic microorganisms, 
toxins, chemicals or physical objects?
    If it became contaminated or were mishandled, could this ingredient 
support the growth of pathogenic microorganisms?
    Are any hazardous chemicals used in growing, harvesting, processing 
or packaging the ingredient?
    Is this ingredient hazardous if used in excessive amounts?
    If this ingredient were left out or used in amounts lower than 
recommended, could it result in microbial growth?
    Are any chemical or physical hazards associated with this 
ingredient?
    8. You can ask the following questions about the product in 
general:
    Have any livestock entering the slaughter establishment been 
subjected to hazardous chemicals?
    Are any returned/reworked products used as ingredients?
    If so, could they cause a hazard?
    Are preservatives or additives used in the product formulation to 
kill or inhibit the growth of microorganisms?
    Do the amount and type of acid ingredients, and the resulting 
product pH, affect the growth/survival of microorganisms?
    Does the water activity of the finished product affect microbial 
growth?
    Should refrigeration be maintained for products during transit or 
in storage?
    Are any chemical or physical hazards associated with any packaging 
materials?
    9. Fully describe the hazards identified.
Second--Observe the Actual Operating Practices in Your Operation
    After describing the hazards you've identified with each step, you 
should:
    1. Observe the actual operation in your establishment and be sure 
that it is the usual process or practice.
    2. Observe employee practices where raw or contaminated product 
could cross-contaminate workers' hands, gloves or equipment used for 
finished/post-process products.
    3. Observe product handling past any kill step for potential cross-
contamination.
    For additional information about potential biological, chemical, 
and physical hazards, you may wish to consult tables 8 through 12 in 
the Meat and Poultry Products Hazards and Controls Guide. They can 
serve as a guide for identifying potential hazards in ingredients and 
at various steps in slaughter and processing. However, they do not 
address every ingredient and every processing step used in the meat and 
poultry industry.

Preventive Measures

    You have identified all significant biological, chemical and 
physical hazards for each processing step and each ingredient. Now, it 
is time to identify measures to prevent hazards from compromising the 
safety of your finished product. Remember, you may not be able to 
identify a preventive measure for every hazard that you identified. You 
are ready to fill in the preventive measure(s) column of the Hazard 
Identification/Preventive Measures Form.
    Remember, HACCP defines a preventive measure as ``Physical, 
chemical, or other means that can be used to control an identified food 
safety hazard.''
    Some examples of preventive measures are:
    In beef slaughter, a chemical hazard could result from animals 
having high levels of drug residues. As a preventive measure, you could 
test the animals or require letters of guarantee from producers that 
the animals are free of harmful residues.
    In poultry slaughter, the venting, opening and evisceration process 
could result in a biological hazard from cross contamination by 
pathogenic microorganisms. Preventive measures for this hazard would 
be: use Good Manufacturing Practices (GMP's) at all times; properly 
maintain and operate equipment used to perform these tasks; and rinse 
food contact surfaces on equipment with chlorinated water between each 
carcass.
    In the grinding step for cooked sausage, a physical hazard could be 
metal fragments from the grinding equipment. There could be three 
different preventive measures for this hazard. You could inspect the 
grinding equipment daily to ensure that it is assembled and operated 
correctly, is functioning properly, and is not worn or damaged. You 
could have an employee visually examine the product at the packaging 
step. Or you could use a metal detector at the packaging step.
    In many operations, the packaging step could pose chemical hazards 
from the packaging materials. A preventive measure could be a letter of 
guarantee from the supplier that the packaging materials are all food 
grade.
    Once you have identified your preventive measures and written them 
on your form, you are ready to go on to the next step in developing 
your HACCP plan. See blank and filled-in forms for preventive measures 
below.

Principle 2--Identify Critical Control Points

    HACCP Principle No. 2 states:
    ``Identify the Critical Control Points (CCPs) in the process.''
    A critical control point (CCP) is defined as ``A point, step, or 
procedure in a food process at which control can be applied and, as a 
result, a food safety hazard can be prevented, eliminated, or reduced 
to acceptable levels.''
    So far, in developing your HACCP plan, you have identified 
biological, chemical, and physical hazards in the raw materials and 
ingredients you use and in the steps of your process. You've also 
identified preventive measures, if they exist, for each hazard that you 
identified. With this information, your next step is to identify the 
points in the process at which the preventive measures can be applied 
to prevent, eliminate, or reduce the hazard. Then you can use the CCP 
Decision Tree to assess each step in the process to determine whether 
it is a critical control point. (Many control points may not be 
critical; often, companies starting out in HACCP identify too many 
control points.)
    Fortunately, a great deal of work has already been done for you in 
identifying CCPs. Many CCPs are already recognized in various food 
processing and production systems. Some common CCPs are:
     Chilling.
      Cooking that must occur for a specific time and 
temperature in order to destroy microbiological pathogens.

[[Page 38889]]

     Product formulation controls, such as mixing ground beef 
and spices to form a meatball.
     Certain processing procedures, such as filling and sealing 
cans.
     Prevention of cross contamination between raw and cooked 
product.
     Certain slaughter procedures, such as evisceration.
    These are just a few examples of measures that may be CCPs.
    There are many more possibilities. Different facilities, preparing 
the same food, can differ in the number and location of hazards and the 
points, steps or procedures which are critical control points. This is 
due, in part, to differences in plant layouts, equipment used, 
selection and sources of raw materials and ingredients, or the process 
that is used.

Steps in Identifying Critical Control Points

    A good tool for identifying Critical Control Points is the CCP 
Decision Tree, shown below. The CCP Decision Tree was developed to help 
companies separate CCPs from other controls. You will get the best 
results if you use the Decision Tree very methodically and use simple, 
descriptive, and familiar wording. You should apply the Decision Tree 
at each step in the process where you have identified a hazard.
    You can use the blank Critical Control Point Determination Form, to 
record the results from your CCP Decision Tree work. Or, you may wish 
to design your own form. An example of a filled-in Critical Control 
Point Determination Form for poultry slaughter at one establishment is 
shown below.
    Determining whether a process step is a CCP is really a basic 
exercise of answering four questions. To use the form and the Decision 
Tree, follow the next six steps:
    1. In Column 1 of the Critical Control Point Determination Form, 
write in each step in the process where you have identified a hazard.
    2. In Column 2, write in the identified hazard(s), indicating 
whether it is biological, chemical or physical. Then take the 
information you wrote on your Hazard Identification/Preventive Measures 
form and answer the following questions for each hazard you identified.
    3. Question #1--Do preventive measures exist for the identified 
hazard?

    Note: From a regulatory standpoint, no further action is 
necessary if the hazard is not reasonably likely to occur.

    If the answer is yes, write YES and proceed to the next question.
    If the answer is no, ask the question ``Is control at this step 
necessary for safety?''
    If control is not necessary at this step in the process, this 
process step is not a CCP. Write NO in Column 3 and write how and where 
this hazard will be controlled. Proceed to the next process step and 
identified hazard you have entered in Columns 1 and 2.
    If control is necessary, in Column 3 explain how the step, process 
or product will be modified to ensure safety.

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    Once the step, process, or product has been modified, return to 
Question #1.
    4. Question #2--Does this step eliminate or reduce the likely 
occurrence of the hazard(s) to an acceptable level?
    If the answer is yes, write YES in Column 4 and identify the step 
as a CCP in Column 7.
    If the answer is no, write NO in Column 4 and proceed to the next 
question.
    5. Question #3--Could contamination with identified hazard(s) occur 
in excess of acceptable levels or could these increase to unacceptable 
levels?
    If the answer is yes, write YES in Column 5 and proceed to the next 
question.
    If the answer is no, write NO in Column 5, indicating that the step 
is not a CCP. Then proceed to the next process step and hazard.
    6. Question #4--Will a subsequent step eliminate identified 
hazard(s) or reduce the likely occurrence to an acceptable level?
    If the answer is yes, write YES in Column 6, indicating that the 
step is not a CCP. Then write down which processing step, which occurs 
later, will reduce the hazard to acceptable levels. Then proceed to the 
next process step and hazard.
    If the answer is no, write NO in Column 6 and identify the step as 
a CCP in Column 7.

Principle 3--Establish Critical Limits for Each Critical Control Point

    HACCP Principle No. 3 states:
    ``Establish critical limits for preventive measures associated with 
each identified CCP.'' 
    The regulation defines critical limit as ``The maximum or minimum 
value to which a physical, biological, or chemical hazard must be 
controlled at a critical control point to prevent, eliminate, or reduce 
to an acceptable level the occurrence of the identified food safety 
hazard.''
 Critical limits are expressed as numbers, such as:

 Time/temperature
 Humidity
 Water activity
 pH
 Salt concentration
 Chlorine level

    You will find that many critical limits for your identified CCPs 
have already been established. You can find these limits in sources 
such as regulatory requirements, scientific literature, experimental 
studies, and through consultation with experts. Some examples of 
regulatory critical limits for CCPs in meat and poultry production are 
shown in Table 7 of the Meat and Poultry Products Hazards and Controls 
Guide.
    You may wish to establish critical limits that are stricter than 
regulatory requirements. However, your critical limits must never be 
less stringent than the requirements.
    In some cases, you will need more than one critical limit to 
control a particular hazard. For example, the critical limits for 
cooked beef patties are time/temperature, pattie thickness, and 
conveyor speed.
    Below you will find an example of a Critical Limits, Monitoring and 
Corrective Actions Form. You can use that form, or develop your own, to 
use in this and the following two sections. You will find an example of 
that form filled in for swine slaughter in one establishment below. You 
can find examples of critical limits for specific processes in the 
HACCP Generic Models.

Steps in Establishing Critical Limits

    1. For each identified CCP, determine if there is a regulatory 
critical limit. If so, write that critical limit--or a more stringent 
one--into the critical limit column of your form.
    For example, the regulatory critical limit for chilled poultry is 
40 degrees F. So, for the chilling CCP in poultry slaughter, you would 
write, in the Critical Limit column of your form: ``Deep breast muscle 
temperature of 40 degrees F. as the carcasses exit the 
chiller.''
    2. If there are no regulatory critical limits for a CCP, you need 
to establish critical limits for the CCP that are adequate to maintain 
control and prevent a food safety hazard. That is the responsibility of 
each establishment. You may wish to obtain the assistance of outside 
HACCP experts to help you determine critical limits for your CCPs. Once 
you have identified critical limits, enter them into the critical limit 
column of your form.
    3. You should also file, for future reference, any documentation 
such as letters from outside HACCP experts or scientific reports 
supporting the critical limits you have identified. This documentation 
will help validate that the limits have been properly established. In 
addition, you should keep on file any test results that show your early 
experience in implementing the HACCP plan, to demonstrate you can 
implement what is written and make it work.

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Principle 4--Establish Monitoring Procedures

    HACCP Principle No. 4 states:
    ``Establish CCP monitoring requirements. Establish procedures for 
using the results of monitoring to adjust the process and maintain 
control.''
    Monitoring is a planned sequence of observations or measurements to 
assess whether a CCP is under control and to produce an accurate record 
for future use in verification.
    Monitoring is essential to a HACCP system. Monitoring can warn you 
if there is a trend towards loss of control, so that you can take 
action to bring your process back into control before a critical limit 
is exceeded. For example, say that an establishment tests the pH of a 
batch of product at 6 a.m., 7 a.m., and 8 a.m. Each time, the pH is 
within acceptable limits, but it is steadily climbing towards the high 
end of the range. This information is showing a trend and the 
establishment should take action to prevent the pH from exceeding the 
critical limits.
    The monitoring procedures you will establish at CCPs will generally 
relate to on-line processes. Monitoring may be continuous or non-
continuous. Continuous monitoring at a CCP usually is done with 
measuring equipment, such as automatic time-temperature equipment used 
at a cooking step. Continuous monitoring is better because it results 
in a permanent record that you can review and evaluate to ensure that 
the CCP is under control. However, you should regularly check 
continuous monitoring equipment for accuracy.
    You should use non-continuous monitoring procedures when continuous 
monitoring is not feasible. Non-continuous monitoring can include: 
visual examinations; monitoring of ingredient specifications; 
measurements of pH, water activity (Aw), and product temperatures; 
attribute sampling; and the like. When you use non-continuous 
monitoring, you need to ensure that the frequency of monitoring is 
enough to ensure that the hazard is under control and that the 
monitoring is performed at random times. For instance, each plant needs 
to set its own times and frequency for checking the cooking time/
temperature of products. This may vary from one establishment to 
another because of differences in plant size, plant layout, the type of 
product, the length of time for processing, and the product flow.
    Each establishment has the responsibility to establish a frequency 
that ensures that the CCP is under control. In some cases, you may have 
to perform tests at a CCP or use statistically based sampling.
    Monitoring will go much more smoothly if you:
     Clearly identify the employee(s) responsible for 
monitoring.
     Train the employee(s) monitoring the CCPs in the testing 
procedures, the critical limits established, the methods of recording 
test results, and actions to be taken when critical limits are 
exceeded.
     Ensure that the employee(s) understand the purpose and 
importance of monitoring.
    You can use the Critical Limits, Monitoring and Corrective Actions 
Form shown below, or you can develop your own form. Below is an example 
of a form filled in for swine slaughter in one establishment.

Steps in Establishing Monitoring Procedures

    You can identify monitoring procedures for your HACCP plan by doing 
the following:
    1. For each CCP, identify the best monitoring procedure.
    2. Determine the frequency of monitoring for each CCP.
    3. Determine if the monitoring activity needs to be done randomly 
to get a good representation of the product throughout the day's 
production. If it does, decide how the random monitoring will be done.
    4. Determine what testing procedures need to be done for each 
monitoring function. For example, will you need to do a chlorine check 
or a temperature measurement?
    5. Identify and train the employee(s) responsible for monitoring.
    6. Make sure that the employee doing the monitoring signs all 
records and documents associated with CCP monitoring. Also make sure 
that the monitoring results are documented or recorded at the time the 
monitoring takes place.
    7. Enter the above information in the monitoring column of your 
form.

Principle 5--Establish Corrective Actions

    HACCP Principle No. 5 states:
    ``Establish corrective action to be taken when monitoring indicates 
that there is a deviation from an established critical limit.''
    The regulation defines corrective action as ``Procedures to be 
followed when a deviation occurs.''
    A deviation is a failure to meet a critical limit.
    Since HACCP is a preventive system to correct problems before they 
affect the safety of the food, you have to plan in advance to correct 
potential deviations from established critical limits. Once your HACCP 
plan is in place, any time a critical limit is not met, you will need 
to take corrective actions. Those corrective actions should include:
    1. Determining the disposition of non-complying product;
    2. Correcting the cause of the non-compliance to prevent a 
recurrence;
    3. Demonstrating that the CCP is once again under control (this 
means examining the process or product again at that CCP and getting 
results that are within the critical limits);
    4. Maintaining records of the corrective actions.
    Under HACCP, you determine in advance what you will do when a 
critical limit is not met at a CCP. The employee(s) monitoring CCPs 
should understand this process and be trained to perform the 
appropriate corrective actions. It is important that an establishment 
record all corrective actions and that the employee responsible for 
taking the corrective actions sign all the documentation.
    In some cases, the product in question will be held for further 
investigation of the deviation. This investigation may require a 
thorough record review, product testing, or consultation with a 
processing authority.
    Some examples of corrective actions are:
     Immediately adjust the process and hold product for 
further evaluation and disposition.
     Empower employees to stop the line when a deviation 
occurs, hold all product not in compliance, and call in the plant's 
quality control manager.
     Rely on an approved alternate process that can be 
substituted for the one that is out of control at the specific critical 
control point. For example, if the in-line eviscerators in a poultry 
slaughter plant are malfunctioning, evisceration can be done by hand as 
long as Good Manufacturing Practices (GMPs) are followed.
    Regardless of the corrective actions you take, you need to keep 
records that include:
     The deviation that was identified.
     The reason for holding the product; the time and date of 
the hold; the amount of product involved; the disposition and/or 
release of product; and the individual who made the disposition 
decision.
     Actions to prevent the deviation from recurring.
    You can use the Critical Limits, Monitoring and Corrective Actions 
form below or you can develop your own

[[Page 38897]]

form. A sample form, filled in for swine slaughter, appears below.

Steps in Establishing Corrective Actions

    1. For each CCP, determine the corrective action to take if the 
critical limits are exceeded. Determine what should be done with the 
product if a deviation occurs at this step. You may need more than one 
corrective action for a CCP.
    2. Develop the record form to capture all the necessary information 
on the deviation, and identify the employee responsible for maintaining 
and signing the record.
    3. Ensure that employees conducting the monitoring at each CCP are 
fully trained and know the corrective actions to take if a deviation 
occurs.
    4. Enter the appropriate corrective action(s) for each CCP in the 
corrective action column of the Critical Limits, Monitoring and 
Corrective Actions form and identify the record that will be 
maintained.

Principle 6--Establish Recordkeeping Procedures

    HACCP Principle No. 6 states:
    ``Establish effective recordkeeping procedures that document the 
HACCP system.''
    Maintaining proper HACCP records is an essential part of the HACCP 
system. Good HACCP records--meaning that they are accurate and 
complete--can be very helpful to you for the following reasons:
     Records serve as written documentation of your 
establishment's compliance with its HACCP plan.
     Records allow you to trace the history of an ingredient, 
in-process operations, or a finished product, should problems arise.
     Records help you identify trends in a particular operation 
that could result in a deviation if not corrected.
     If you were ever faced with a product recall, HACCP 
records could help you identify and narrow the scope of such a recall.
     Well-maintained records are good evidence in potential 
legal actions against an establishment.
    In accordance with the HACCP principles, your HACCP system should 
include records for CCPs, establishment of critical limits, handling of 
deviations, and your HACCP plan. Examples of these and other HACCP 
forms that may be useful in assembling the HACCP plan are located in 
the appropriate sections of this guidebook. For your review, these 
forms are:

Product(s) Description Form
Product and Ingredients Form
Process Flow Diagram Form
Hazard Identification/Preventive Measures Form
CCP Determination Form
Critical Limits, Monitoring and Corrective Actions Form
Recordkeeping and Verification Form (Verification will be explained in 
the next section of this guidebook)
HACCP Plan Form

    In many cases, the records you currently maintain may be sufficient 
to document your HACCP system. Records must contain at least the 
following information: title and date of record; product 
identification; critical criteria or limits; a line for the monitor's 
signature; a place for the reviewer's signature; and, an orderly manner 
for entering the required data.
    An example of a blank Recordkeeping and Verification Form is found 
below. Also below is an example of the form filled in for cooked 
sausage in one establishment.

Steps in Establishing Recordkeeping Procedures

    1. Review the records you currently maintain and determine which 
ones adequately address the monitoring of the CCPs you have identified, 
or develop forms for this information.
    2. Develop any forms necessary to fully record corrective actions 
taken when deviations occur.
    3. Develop forms to document your HACCP system. (This will be 
explained in the next section, on verification).
    4. Identify the monitoring employees responsible for entering data 
into the records and ensure that they understand their roles and 
responsibilities.
    5. Enter the record form name(s) on the Recordkeeping and 
Verification Form under the records column adjacent to the appropriate 
CCP. (Verification will be explained in the next section).
    6. Enter the appropriate record form name(s) on the Recordkeeping 
and Verification Form under the verification procedures column adjacent 
to the appropriate CCP. (Verification will be explained in the next 
section).

Principle 7--Establish Verification Procedures

    HACCP Principle No. 7 states:
    ``Establish procedures to verify that the HACCP system is working 
correctly.''
    After a HACCP plan has been put into place, verification activities 
occur on an ongoing basis. Verification entails the use of methods, 
procedures, or tests in addition to those used in monitoring, to 
determine whether the HACCP system is operating as intended.
    Simply stated, you need to verify that your HACCP system is working 
the way you expected it to work. There are several areas that warrant 
checking. You will probably first want to review your HACCP plan to 
determine whether the CCPs and critical limits that you established are 
really the right ones and that you are controlling and monitoring them 
adequately. You should also make sure that employees are following your 
procedures for taking corrective actions when a critical limit is 
exceeded. Finally, you should check to see that your employees are 
keeping good HACCP records.
    By doing these things, you will evaluate the day-to-day operation 
of your HACCP system. Don't be surprised if you find that you need to 
fine-tune your HACCP plan.
    Some things you can do to verify your HACCP system are:
     Analytically test or audit your monitoring procedures;
     Calibrate your temperature equipment;
     Sample your product, including microbiological sampling;
     Review your monitoring records;
     Review your records of deviations and product 
dispositions;
     Inspect and audit your establishment's operations;
     Sample for environmental and other concerns.

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    You can use the Recordkeeping and Verification Form to record your 
verification procedures. A sample blank form appears below. An example 
filled in for cooked sausage in one establishment appears below.

Steps in Establishing Verification Procedures

    1. Determine the appropriate verification procedure to ensure that 
each CCP and critical limit is adequately controlled and monitored.
    2. For each CCP, determine procedures to ensure that employees are 
following your established procedures for handling product deviations 
and for recordkeeping.
    3. Identify the frequencies for conducting any verification checks 
and the records where the results will be recorded.
    4. Enter the appropriate details on the Recordkeeping and 
Verification Form for future reference.

Validate Your HACCP Plan

    It is very important to validate your HACCP plan. The regulation 
defines validation as ``the scientific and technical process for 
determining that the CCPs and associated critical limits are adequate 
and sufficient to control likely hazards.''
    Simply put, when you validate your HACCP plan, you demonstrate that 
what you have written and put into place can actually prevent, 
eliminate, or reduce the levels of hazards that you have identified.
    To validate your HACCP plan, you need to assemble information to 
show that your HACCP plan will work to control the process and to 
prevent food safety hazards. There are two types of information that 
you will probably collect. First, you will likely gather supporting 
scientific information, such as studies that establish the time and 
temperatures necessary to kill certain harmful bacteria. Second, you 
may wish to gather practical information, such as test results from 
products produced under your HACCP plan. An example of a test might be 
microbiological analysis of your finished, ready-to-eat products. There 
are many sources of information to validate your HACCP plan, including: 
the scientific literature, product testing results, experimental 
research results, scientifically-based regulatory requirements, 
official FSIS guidelines, or information developed by process 
authorities.
    You have a great deal of flexibility in assembling the information 
to validate your plan, in terms of both source and quantity of 
information. For example, a slaughter plant should validate that its 
plan ensures residue control, to prevent violative levels of chemicals, 
animal drugs or pesticides in carcasses. A slaughter plant might choose 
to purchase animals only from suppliers who provide veterinary 
certifications that the animals have been raised under a program that 
assures that all animal drugs, pesticides, and other chemicals are 
properly used. In this situation, the establishment could validate this 
critical control point with the following information: a copy of the 
residue prevention program under which the producer is certified; a 
report of an on-site visit to the feedlot; and results of analyses of 
carcasses for compounds of concern.
    Validation is simpler for HACCP plans for products such as cooked 
beef, roast beef, or cooked corned beef. Current regulatory 
requirements for these products include scientifically-based processing 
times, temperatures, and handling requirements. Your HACCP plan would 
need only to reflect these regulatory requirements; additional 
information would be unnecessary. In this case, you could do a minimal 
number of product analyses to demonstrate that hazards of concern, such 
as Salmonella, were not found in the products produced under the HACCP 
plan.
    It is important that you reassess your HACCP plan at least once a 
year and whenever any of the following occurs:
    1. Potential new hazards are identified that may be introduced into 
the process for the product.
    2. You add new ingredients.
    3. You change the process steps or procedures.
    4. You introduce new or different processing equipment.

Finishing Your HACCP Plan

    Now you are ready to assemble all your information into one HACCP 
Plan. A sample HACCP Plan blank form is provided below. An example of a 
form filled in for one establishment's canned beef stew process is 
shown below. It is important for your records that you assemble all 
your information into a final HACCP plan. To make sure that your HACCP 
Plan is complete, you may want to check it against the checklist 
provided in the next section of this guidebook.
    Now you are ready to put your HACCP Plan into action and make HACCP 
a reality in your establishment.

BILLING CODE 3410-DM-P

[[Page 38901]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.016



[[Page 38902]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.017



BILLING CODE 3410-DM-C

[[Page 38903]]

HACCP Plan Checklist
    You can use the HACCP Plan Checklist provided in this section to 
ensure that your HACCP plan adequately addresses all seven HACCP 
principles.
    When completing the checklist, if you answer ``NO'' to any 
question, you reevaluate that section of the HACCP plan and make 
whatever modifications are necessary. Some modifications may require 
the assistance of recognized HACCP experts.
    Any time you make major changes to the HACCP plan based upon 
product or process modifications, it would be advisable to review the 
checklist to ensure that the revisions are acceptable.
    You can keep the HACCP Plan Checklist as part of your HACCP plan 
for future reference and to provide documented evidence that your HACCP 
plan addresses all seven HACCP principles.
ESTABLISHMENT NO.------------------------------------------------------
PRODUCT/PROCESS--------------------------------------------------------
DATE-------------------------------------------------------------------

                                              HACCP Plan Checklist                                              
----------------------------------------------------------------------------------------------------------------
                                                                                                                
----------------------------------------------------------------------------------------------------------------
A. DESCRIBE THE PRODUCT                                                                             YES      NO 
    1. Does the HACCP plan include:                                                                             
        a. The producer/establishment and the product name?                                                     
        b. The ingredients and raw materials used along with the product receipt or formulation?                
        c. The packaging used?                                                                                  
        d. The temperature at which the product is intended to be held, distributed and sold?                   
        e. The manner in which the product will be prepared for consumption?                                    
    2. Has a flow diagram for the production of the product been developed that is clear,                       
     simple, and descriptive of the steps in the process?                                                       
    3. Has the flow diagram been verified for accuracy and completeness against the actual                      
     operating process?                                                                                         
B. CONDUCT A HAZARD ANALYSIS                                                                        YES      NO 
    1. Have all steps in the process been identified and listed where hazards of potential                      
     significance occur?                                                                                        
                                                                                                                
    2. Have all hazards associated with each identified step been listed?                                       
    3. Have safety concerns been differentiated from quality concerns?                                          
    4. Have preventive measures to control the identified hazard been identified, if they exist,                
     and listed?                                                                                                
C. IDENTIFY CRITICAL CONTROL POINTS                                                                 YES      NO 
    1. Has the CCP Decision Tree been used to help determine if a particular step is a CCP for a                
     previously identified hazard?                                                                              
    2. Have the CCPs been entered on the forms?                                                                 
    3. Have all significant hazards identified during the hazard analysis been addressed?                       
D. ESTABLISH CRITICAL LIMITS                                                                        YES      NO 
    1. Have critical limits been established for each preventive measure at each CCP?                           
    2. Has the validity of the critical limits to control the identified hazard been                            
     established?                                                                                               
    3. Were critical limits obtained from the regulations, processing authority, etc?                           
    4. Is documentation attesting to the adequacy of the critical limits maintained on file at                  
     the establishment?                                                                                         
E. ESTABLISH MONITORING PROCEDURES                                                                  YES      NO 
    1. Have monitoring procedures been developed to assure that preventive measures necessary                   
     for control at each CCP are maintained within the established critical limits?                             
    2. Are the monitoring procedures continuous or, where continuous monitoring is not possible,                
     is the frequency of monitoring sufficiently reliable to indicate that the hazard is under                  
     control?                                                                                                   
    3. Have procedures been developed for systematically recording the monitoring data?                         
    4. Have employees responsible for monitoring been identified and trained?                                   
    5. Have employees responsible for reviewing monitoring records been identified and trained?                 
    6. Have signatures of responsible individuals been required on the monitoring records?                      
    7. Have procedures been developed for using the results of monitoring to adjust the process                 
     and maintain control?                                                                                      
F. ESTABLISH CORRECTIVE ACTIONS                                                                     YES      NO 
    1. Have specific corrective actions been developed for each CCP?                                            
    2. Do the corrective actions address:                                                                       
        a. Reestablishment of process control?                                                                  
        b. Disposition of affected product?                                                                     
        c. Procedures to correct the cause of non-compliance and to prevent the deviation from                  
         recurring?                                                                                             
    3. Have procedures been established to record the corrective actions?                                       
    4. Have procedures been established for reviewing the corrective action records?                            
G. ESTABLISH RECORDKEEPING PROCEDURES                                                               YES      NO 
    1. Have procedures been established to maintain the HACCP plan on file at the establishment?                
    2. Do the HACCP records include:                                                                            
        Description of the product and its intended use?                                                        
        Flow diagram for the process, indicating CCPs?                                                          
        Preventive measures?                                                                                    
        Critical limits?                                                                                        
        Monitoring system:                                                                                      
            Corrective action plans for deviations from critical limits?                                        
            Recordkeeping procedures for monitoring?                                                            
        Procedures for verification of the HACCP system?                                                        
H. ESTABLISH VERIFICATION PROCEDURES                                                                YES      NO 
    1. Have procedures been included to verify that all significant hazards were identified in                  
     the HACCP plan when it was developed?                                                                      
    2. Have procedures been included to verify that the critical limits are adequate to control                 
     the identified hazards?                                                                                    
    3. Are procedures in place to verify that the HACCP system is functioning properly?                         

[[Page 38904]]

                                                                                                                
    4. Are procedures in place to reassess the HACCP plan and system on a regular basis or                      
     whenever significant product, process or packaging changes occur?                                          
----------------------------------------------------------------------------------------------------------------



References

    Agriculture Canada. Food Safety Enhancement Program--
Implementation Manual. Camelot Drive, Nepean, Ontario, Canada. 
American Meat Institute Foundation. HACCP: The Hazard Analysis and 
Critical Control Point System in the Meat and Poultry Industry. 
1994. Washington, D.C.
    Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease 
outbreaks in the United States, 1973-1987: Pathogens, vehicles, and 
trends.'' J. Food Protect. 53: 804-817.
    Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease 
outbreaks, 5-year summary, 1983-1987.'' J. Food Protect. 53: 711.
    Corlett, D.A., Jr. and R.F. Steir. 1991. ``Risk assessment 
within the HACCP system.'' Food Control 2:71-72.
    Council for Agricultural Science and Technology. Risks 
Associated with Foodborne Pathogens. February 1993.
    Environmental Protection Agency. 1992. Tolerances for Pesticides 
in Foods. Title 40, Code of Federal Regulations, Part 185. U.S. 
Government Printing Office, Washington, DC.
    FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington, 
DC.
    FDA. 1994. Fish and Fishery Products Hazards and Control Guide--
Get Hooked on Seafood Safety. Office of Seafood. Washington, DC.
    International Commission on Microbiological Specification for 
Foods. 1989. Microorganisms in Foods 4. Application of hazard 
analysis and critical control point (HACCP) system to ensure 
microbiological safety and quality. Blackwell Scientific 
Publications, Boston.
    National Advisory Committee on Microbiological Criteria for 
Foods (NACMCF). March 20, 1992--Hazard Analysis and Critical Control 
Point System. Int. J. Food Micr. 16: 1-23.
    National Advisory Committee on Microbiological Criteria for 
Foods (NACMCF). June 1993--Report on Generic HACCP for Raw Beef. 
Food Micr. 10: 449-488.
    Oblinger, J. L., ed. 1988. ``Bacteria Associated with Foodborne 
Illnesses, A Scientific Status Summary by the Institute of Food 
Technologists Expert Panel on Food Safety and Nutrition.'' Food 
Technol. 42(4).
    Padhye, N. V.; Doyle, M. P. 1992. ``E. Coli 0157:H7 
Epidemiology, pathogenesis, and methods for detection in food.'' J. 
Food Prot. 55:55-565.
    Pierson, M. D. and Corlett, D. A., Jr. ed. 1992. HACCP/ 
Principles and Applications. Van Nostrand Reinhold.
    Schuchat, A., Swaminathan, B. And Broome, C.V. 1991. 
``Epidemiology of human listeriosis.'' Clin. Microbiol. Rev. 4: 169-
183.
    Stevenson, K. E. ed. 1993. HACCP-Establishing Hazard analysis 
Critical Control Point Programs. A Workshop Manual. The Food 
Processors Institute. Washington, D.C.
    Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth. I.K. 
1988. ``Campylobacter isolates in the United States, 1982-1986.'' 
In, CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS- 2) : 1-
13.
    Tauxe, R. V., Epidemiology of Camplyobacter jejuni infections in 
the United States and other Industrialized Nations. In Nachamkin, 
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and 
Future Trends, 1994, chapter 2, pages 9-19.
    Todd, E. 1990. ``Epidemiology of Foodborne Illness: North 
America.'' The Lancet 336:788.
    Tompkin, R. B. 1990. ``The Use of HACCP in the Production of 
Meat and Poultry Products. J. of Food Protect.'' 53(9): 795-803.
    Tompkin, R. B. 1995. The Use of HACCP for Producing and 
Distributing Processed Meat and Poultry Products. In Advances in 
Meat Research. Volume 10. Hazard Analysis Critical Control Point 
(HACCP) in Meat, Poultry and Seafoods. Chapman & Hall (In Press).
    USDA, 1994. List of Propriety Substances and Nonfood Compounds 
Authorized for Use under USDA Inspection and Grading Programs. USDA, 
FSIS, Washington, DC.

Internet Home Pages

Agriculture Canada
http://aceis.agr.ca

Center for Disease Control
http://fftp.cdc.gov/pub/mmwr/MMWRweekly

Food Law Sites
http://www.fsci.umn.edu/FoodLaw/foodlaw.html

HACCP95
http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html

International Meat and Poultry HACCP Alliance
http://ifse.tamv.edu./haccpall.html

Material Safety Data Sheets
http://listeria.nwfsc.noaa.gov/msds.html

U.S. Department of Agriculture
http://www.usda.gov

U.S. Food and Drug Administration/Bad Bug Book
http://vm.cfsan.fda.gov/list.html

Appendix D--Hazards and Preventive Measures Guide

Preface

    This Guide is designed to help a plant's HACCP team conduct a 
hazard analysis (HACCP Principle 1) by providing both general and 
detailed information on hazards associated with meat and poultry 
products and by listing some of the controls that can be used to 
prevent or manage those hazards. When using this Guide it is very 
important to remember that it is not all-inclusive: There may be other 
hazards associated with ingredients or processes; there may be other 
control measures. The examples assembled here are to help plant HACCP 
teams think through all the hazards that could affect their product and 
know about various controls that can be used.
    Section I describes some of the biological (including 
microbiological), chemical, and physical hazards generally recognized 
and associated with meat and poultry products. This section can serve 
as a resource when the HACCP team begins the hazard analysis. It is 
probably useful to read through this general information early in the 
process of developing the HACCP plan. This will help the team form an 
idea of what is meant by a given hazard.
    Section II provides information on generally recognized preventive 
measures used in the meat and poultry industry to control biological, 
chemical, and physical hazards. This section also has examples of 
regulatory critical limits associated with some preventive measures.
    Sections III, IV, and V list processing steps, hazards, and 
controls for beef, poultry, and swine slaughter. This section should be 
used with the process flow diagram developed by the HACCP team.
    Section VI presents hazards and controls organized according to 
ingredients, including both meat and poultry ingredients and other 
ingredients used in meat and poultry production. This section should be 
used with the list of ingredients developed by the HACCP team.
    Section VII contains a set of tables identifying potential hazards 
at various processing steps used to produce meat and poultry products. 
This section should be used with the process flow diagram developed by 
the plant's HACCP team.
    Section VIII contains a list of valuable references that will help 
the plant's HACCP team further develop the HACCP plan.

Section I

Overview of Biological, Chemical, and Physical Hazards
    In a HACCP system, a hazard is defined as a biological, chemical, 
or physical property that may cause a food

[[Page 38905]]

to be unsafe for human consumption. This guide is a reference for plant 
HACCP teams to use in their hazard identification and analysis. It is 
not intended to be totally inclusive; the team may have other 
information or may rely on additional references.
Biological Hazards
    Biological hazards, which are mainly bacterial, can cause either 
foodborne infections or intoxications. A foodborne infection is caused 
by a person ingesting a number of pathogenic microorganisms sufficient 
to cause infection as a result of their multiplication, e.g., 
salmonellosis. A foodborne intoxication is caused by the ingestion of 
already formed toxins produced by some bacteria when they multiply in 
food, e.g., staphylococcal enterotoxin.
    When assessing bacterial hazards to human health in meat and 
poultry products, nine pathogenic bacteria must be considered. The 
following identifies and discusses the nine pathogenic microorganisms 
of concern.

Bacillus cereus

    B. cereus foodborne intoxication includes two recognized types of 
illness--diarrheal and emetic (vomiting).
    Foods associated with illness include: Boiled and fried rice, 
custards, cecal products meats, vegetables, and fish; food mixtures 
such as sauces, puddings, soups, casseroles, pastries, and salads.

Campylobacter jejuni

    Campylobacteriosis is the illness caused by C. jejuni. It is also 
often known as campylobacter enteritis or gastroenteritis.
    Food associated with illness include: raw and undercooked chicken, 
raw milk, non-chlorinated water.

Clostridium botulinum

    Foodborne botulism (as distinct from wound botulism and infant 
botulism) is a severe foodborne disease caused by the ingestion of 
foods containing the potent neurotoxin formed during growth of the 
organism. Botulism has a high mortality rate if not treated immediately 
and properly.
    Foods associated with disease include: sausages, meat products, and 
seafood products, improperly canned foods, vegetable products.

Clostridium perfringens

    Perfringens foodborne illness is the term used to describe the 
common foodborne disease caused by the release of enterotoxin during 
sporulation of C. perfringens in the gut.
    Foods associated with illness include: meat and poultry products 
and gravy.

Escherichia coli O157:H7

    Hemorrhagic colitis is the name of the acute disease caused by E. 
coli O157:H7.
    Foods associated with illness: undercooked or raw hamburger (ground 
beef) has been implicated in many documented outbreaks and in other 
sporadic cases; other meat products, raw milk, untreated water.

Listeria monocytogenes

    Listeriosis is the name of the general group of disorders caused by 
L. monocytogenes.
    Foods associated with illness: cole slaw, cooked poultry, cooked 
meat, and raw milk, supposedly pasteurized fluid milk, cheeses 
(particularly soft-ripened varieties). Its ability to grow at 
temperatures as low as 3  deg.C permits multiplication in refrigerated 
foods.

Salmonella spp

    S. typhi and the paratyphoid bacteria are normally septicemic and 
produce typhoid or typhoid-like fever in humans and are pathogenic only 
for humans. Other forms of salmonellosis generally produce milder 
symptoms. The organism is found in the intestinal tracts of warm 
blooded animals.
    Foods associated with illness: raw and cooked meats, poultry, eggs 
(and exterior of egg shells), untreated water, raw milk and dairy 
products, fish, shrimp, frog legs, yeast, sauces and salad dressing, 
etc.

Staphylococcus aureus

    Staphylococcal food poisoning (staphylococcal enterotoxicosis; 
staphylococcal enterotoxemia) is the name of the condition caused by 
the enterotoxins that some strains of S. aureus produce.
    Foods associated with illness: meat and meat products; poultry and 
egg products; egg, tuna, ham, chicken, potato, and macaroni salads; 
sandwich fillings; milk and dairy products; etc.

Yersinia enterocolitica

    Yersiniosis is the name of the disease caused by pathogenic species 
in the genus Yersinia. The disease is a gastroenteritis with diarrhea 
and/or vomiting, and fever and abdominal pain.
    Foods associated with illness: meats, oysters, fish, milk, and 
chitterlings.

        Table 1.--Characteristics of Growth for Nine Pathogens Associated With Meat and Poultry Products        
----------------------------------------------------------------------------------------------------------------
                                                                  Temperature of                                
                            Pathogens                                 growth            pH          Minimum Aw  
----------------------------------------------------------------------------------------------------------------
Bacillus cereus.................................................    10-48  deg.C         4.9-9.3            0.95
Campylobacter jejuni............................................    30-47  deg.C         6.5-7.5  ..............
Clostridium botulinum...........................................   3.3-46  deg.C            >4.6            0.94
(Types A,B,E)...................................................  ..............  ..............  ..............
Clostridium perfringens.........................................    15-50  deg.C         5.5-8.0            0.95
Escherichia coli O157:H7........................................    10-42  deg.C         4.5-9.0  ..............
Listeria monocytogenes..........................................   2.5-44  deg.C         5.2-9.6  ..............
Salmonella......................................................     5-46  deg.C  ..............        4-9 0.94
Staphylococcus aureus...........................................   6.5-46  deg.C           5.2-9            0.86
Yersinis enterocolitica.........................................     2-45  deg.C         4.6-9.6  ..............
----------------------------------------------------------------------------------------------------------------

    Zoonotic agents are biological hazards that cause disease in 
animals and can be transmitted and cause disease in humans. The 
following lists some zoonotic hazards:
    Trichinella spiralis is a nematode parasite whose larval from 
encysts primarily in the striated muscle of pigs, horses, rats, bears 
and other mammals. Infection in humans results in ``flu-like symptoms'' 
(diarrhea, fever, stiffness, muscle pain, respiratory distress, etc.) 
And heavy infection may lead to death.
    Foods associated with illness include: raw and undercooked pork, 
bear and equine meat.
    Taenia saginata is a human tapeworm whose larval form (Cysticercus 
bovis) encysts in the tissues of cattle.
    Foods associated with illness include: raw or undercooked beef.
    Taenia solium is a human tapeworm whose larval form (Cystricercus 
cellulosae) encysts in the tissues of pigs,

[[Page 38906]]

dogs, and humans. Cysts in humans are most common in the subcutaneous 
tissues, eye and the brain.
    Foods associated with illness include: raw or undercooked pork.
    Toxoplasma gondii is a protozoan parasite that encysts in the 
tissues of a variety of mammalian hosts including pigs. Human infection 
may result in ``flu like'' symptoms in adults, late term abortions in 
pregnant women or serious congenial infections in children.
    Foods associated with illness include: raw or undercooked pork.
    Balantidium coli is a protozoal organism.
    Foods associated with illness include: raw, undercooked pork (fecal 
contamination)

Cryptosporidium spp.

    Foods associated with illness include: inadequately treated water, 
raw or undercooked veal or beef.

Chemical Hazards

    While biological hazards are of great concern because contaminated 
foods can cause widespread illness outbreaks, chemical hazards may also 
cause foodborne illnesses, although generally affecting fewer people.
    Chemical hazards can originate from four general sources:
    (1) Agriculture chemicals: pesticides, herbicides, animal drugs, 
fertilizers, etc.
    (2) Plant chemicals: cleaners, sanitizers, oils, lubricants, 
paints, pesticides, etc.
    (3) Naturally-occurring toxicants: products of plant, animal, or 
microbial metabolisms such as aflatoxins, etc.
    (4) Food chemicals: preservatives, acids, food additives, sulfiting 
agents, processing aids, etc.
    (5) Environmental contaminants: lead, cadmium, mercury, arsenic, 
PCBs.
    For many years the Food Safety and Inspection Service has conducted 
a National Residue Program to monitor the occurrence of residues from 
hazardous chemicals in meat and poultry products. Under a HACCP regime, 
frontline responsibility for control of residues from animal drugs or 
environmental contaminants will move from the government to the 
industry, although the agency will continue to verify that these 
controls and preventive measures are effective. Companies that 
slaughter livestock and poultry will probably find the FSIS National 
Residue Program Plan to be a useful document. The plan contains lists 
of compounds that might leave residues in the tissues of animals or 
birds, and provides some information on their relative risk through the 
rankings in the Compound Evaluation System. It provides information on 
which compounds FSIS has included in its annual testing program. It 
also provides information on the methods that are used to test for the 
compounds. Another FSIS document, the Domestic Residue Data Book, 
presents the results of FSIS testing. These data can help a HACCP team 
understand the overall hazard presented by various residues, although 
each company should gather information about the residue control 
performance of its own suppliers.
    Another useful reference about hazardous chemicals is the FSIS List 
of Proprietary Substances and Nonfood Compounds. This publication lists 
substances used in the preparation of product and nonfood compounds 
used in the plant environment that have been authorized by FSIS.
    Table 2 identifies some additional sources of chemical hazards. 
References listed in Section VIII can be used by the HACCP team in 
evaluating the potential chemical hazards associated with their product 
or process.

                                                           Table 2.--Types of Chemical Hazards                                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Location                                                                      Hazard                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
Raw Materials.......................  Pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metals, PCBs.                           
                                      Color additives, inks, indirect additives, packaging materials.                                                   
Processing..........................  Direct food additives--preservatives (nitrite), flavor enhancers, color additives.                                
                                      Indirect food additives--boiler water additives, peeling aids, defoaming agents.                                  
Building and Equipment Maintenance..  Lubricants, paints, coatings.                                                                                     
Sanitation..........................  Pesticides, cleaners, sanitizers.                                                                                 
Storage and Shipping................  All types of chemicals, cross contamination.                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------

Physical Hazards

    Physical hazards include a variety of materials referred to as 
extraneous materials or foreign particles or objects. A physical hazard 
can be defined as any physical material not normally found in a food 
that can cause illness or injury to a person consuming the product.
    Physical hazards in finished products can arise from several 
sources, such as contaminated raw materials, poorly designed or 
maintained facilities and equipment, faulty procedures during 
processing, and improper employee training and practices. Table 3 
identifies some common physical hazards and their causes or sources.

                                                           Table 3.--Types of Physical Hazards                                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Hazard                                                                   Source or cause                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glass...............................  Bottles, jars, light fixtures, utensils, gauge covers, thermometers.                                              
Metal...............................  Nuts, bolts, screws, steel wool, wire, meat hooks.                                                                
Stones..............................  Raw materials.                                                                                                    
Plastics............................  Packaging materials, raw materials.                                                                               
Bone................................  Raw material, improper plant processing.                                                                          
Bullet/BB Shot/Needles..............  Animals shot in field, hypodermic needles used for infections.                                                    
Jewelry.............................  Pens/pencils, buttons, careless employee practices.                                                               
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 38907]]



Section II

Controls and Critical Limits for Biological, Chemical, and Physical 
Hazards
    When all significant biological, chemical, and physical hazards are 
identified along with their points of occurrence, the next task is to 
identify measures to prevent the hazards from compromising the safety 
of the finished product.
    Preventive measures or controls can be defined as physical, 
chemical, or other factors that can be used to remove or limit an 
identified hazard. When considering preventive measures or controls, a 
limit must be established--this is the criterion that must be met to 
ensure safety. For example, proper heat treatment will control some 
pathogenic bacteria, and it is thus crucial to know what time/
temperature combinations constitute proper heat treatment for various 
products; these time/temperature combinations are the critical limits. 
Another example of a preventive measure for a biological hazard is the 
chlorination of poultry chiller water to prevent cross contamination of 
carcasses with Salmonella.
    With identified physical hazards, the most common preventive 
measures may be visual examinations of product or the use of a metal 
detector. Chemical hazards associated with raw materials may be 
controlled through detailed product specifications, letters of 
guarantee, or purchase specifications.
    Tables 4, 5, and 6 identify preventive measures that may be 
considered by the HACCP team. Table 7 gives some examples of regulatory 
limits.

    Table 4.--Examples of Preventive Measures for Biological Hazards    
------------------------------------------------------------------------
                Pathogen                  Preventive measure or control 
------------------------------------------------------------------------
Bacillus cereus........................  Proper holding and cooling     
                                          temperatures of foods; thermal
                                          processing of shelf-stable    
                                          canned food.                  
Campylobacter jejuni...................  Proper pasteurization or       
                                          cooking; avoiding cross-      
                                          contamination of utensils,    
                                          equipment; freezing;          
                                          atmospheric packaging.        
Clostridium botulinum..................  Thermal processing of shelf-   
                                          stable canned food; addition  
                                          of nitrite and salt to cured  
                                          processed meats; refrigeration
                                          of perishable vacuum packaged 
                                          meats; acidification below pH 
                                          4.6; reduction of moisture    
                                          below water activity of 0.93. 
Clostridium perfringens................  Proper holding and cooling     
                                          temperatures of foods; proper 
                                          cooking times and             
                                          temperatures; adequate cooking
                                          and avoidance of cross-       
                                          contamination by unsanitary   
                                          equipment or infected food    
                                          handlers.                     
Listeria monocytogenes.................  Proper heat treatments; rigid  
                                          environmental sanitation      
                                          program; separation of raw and
                                          ready-to-eat production areas 
                                          and product.                  
Salmonella spp.........................  Proper heat treatment;         
                                          separation of raw and cooked  
                                          product; proper employee      
                                          hygiene; fermentation         
                                          controls; decreased water     
                                          activity; withdrawing feed    
                                          from animals before slaughter;
                                          avoiding exterior of hide from
                                          contacting carcass during     
                                          skinning; antimicrobial       
                                          rinses; scalding procedures;  
                                          disinfecting knives.          
Staphylococcus aureus..................  Employee hygiene; proper       
                                          fermentation and pH control;  
                                          proper heat treatment and post-
                                          process product handling      
                                          practices; reduced water      
                                          activity.                     
Yersinia enterocolitica................  Proper refrigeration; heat     
                                          treatments; control of salt   
                                          and acidity; prevention of    
                                          cross-contamination.          
------------------------------------------------------------------------


     Table 5.--Examples of Preventive Measures for Chemical Hazards     
------------------------------------------------------------------------
                 Hazard                         Preventive measure      
------------------------------------------------------------------------
Naturally-Occurring Substances.........  Supplier warranty or guarantee;
                                          verification program to test  
                                          each supplier's compliance    
                                          with the warranty or          
                                          guarantee.                    
Added Hazardous Chemicals..............  Detailed specifications for    
                                          each raw material and         
                                          ingredient; warranty or letter
                                          of guarantee from the         
                                          supplier; visiting suppliers; 
                                          requirement that supplier     
                                          operates with a HACCP plan;   
                                          testing program to verify that
                                          carcasses do not have         
                                          residues.                     
In-Process Chemicals...................  Identify and list all direct   
                                          and indirect food additives   
                                          and color additives; check    
                                          that each chemical is         
                                          approved; check that each     
                                          chemical is properly used;    
                                          record the use of any         
                                          restricted ingredients.       
------------------------------------------------------------------------


     Table 6.--Examples of Preventive Measures for Physical Hazards     
------------------------------------------------------------------------
                 Hazard                         Preventive measure      
------------------------------------------------------------------------
Foreign objects in raw materials.......  Supplier's HACCP plan; use of  
                                          specifications, letters of    
                                          guarantee; vendor inspections 
                                          and certification; in-line    
                                          magnets; screens, traps, and  
                                          filters; in-house inspections 
                                          of raw materials.             
Foreign objects in packaging materials,  Supplier's HACCP plan; use of  
 cleaning compounds, etc.                 specifications, letters of    
                                          guarantee; vendor inspections 
                                          and certification; in-house   
                                          inspections of materials.     
Foreign objects introduced by            In-line metal detectors; visual
 processing operations or employee        product examinations; proper  
 practices.                               maintenance of equipment;     
                                          frequent equipment            
                                          inspections.                  
------------------------------------------------------------------------


[[Page 38908]]



              Table 7.--Some Examples of Regulatory Limits              
------------------------------------------------------------------------
                                                              Regulatory
              Hazard                   Regulatory limit        citation 
------------------------------------------------------------------------
biological: Microbial growth due   All poultry must be       Sec.  381.6
 to temperature abuse-Poultry       chilled immediately                6
 Chilling.                          after processing to a               
                                    temperature of 40                   
                                    deg.F or less.                      
chemical: Excess chemicals         Chemicals used are        Sec.  318.7
 contact product.                   approved for the                    
                                    intended use and at                 
                                    appropriate amounts.                
chemical: Chemical hazard from     Edible products must be   Sec.  317.2
 packaging materials.               packaged in container              4
                                    that will not                       
                                    adulterate product or               
                                    be injurious to health.             
                                    Packaging materials                 
                                    must be covered by a                
                                    letter of guaranty.                 
biological: Trichinae in pork....  Products containing pork  Sec.  318.1
                                    muscle tissue must be              0
                                    effectively heated,                 
                                    refrigerated, or cured              
                                    to destroy any possible             
                                    live trichinae.                     
biological: Pathogens in ready to  For destruction of        Sec.  318.1
 eat products.                      pathogens that may                 7
                                    survive a dry heat                  
                                    process. One of the                 
                                    time/temperature                    
                                    combinations for cooked             
                                    beef, roast beef, and               
                                    cooked corned beef;                 
                                    e.g., 143  deg.F\61.7               
                                    deg.C minimum                       
                                    temperature at minimum              
                                    time of 6 minutes.                  
physical: Extraneous material      Sampled carcasses         Sec.  381.7
 found on post chill examination    observed for                       6
 of poultry carcasses.              conformance with post               
                                    chill criteria,                     
                                    including unidentified              
                                    foreign material.                   
------------------------------------------------------------------------

Section III

Table 8.--Red Meat (Beef) Slaughter Hazards and Controls Use of 
Information
    This section contains examples of common process steps in beef 
slaughter. With each processing step, shown in the first column, you 
will find an ``X'' in the next three columns to tell you if there is a 
Biological hazard in column 2, a Chemical hazard in column 3, or a 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for your plant's beef slaughter process.

                                       Table 8.--Red Meat Slaughter: Beef                                       
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
 Red meat slaughter-beef: examples of                     chemical, or physical        Controls or preventive   
           processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Receiving & Holding..................        X        --Residues present in edible  --Residue certification     
                                                       tissues above tolerances.     presented for live         
                                                                                     animal(s).                 
Skinning.............................   X             --Micro contamination of      --Skinning procedures are   
                                                       carcass surface due to        accomplished without hair  
                                                       contaminated outside hide     or visible fecal           
                                                       surface--contamination of     contamination of the       
                                                       carcass from floor--cross-    carcass.--Careful employee 
                                                       contamination.                practices.--Udder and      
                                                                                     puzzle removal are         
                                                                                     accomplished without       
                                                                                     contamination of edible    
                                                                                     product.                   
Evisceration.........................   X             --cross-contamination from    --Esophagus is tied to      
                                                       broken viscera.               prevent escape of stomach  
                                                                                     contents--Bung is dropped  
                                                                                     with sanitized knife and   
                                                                                     bagged to prevent escape of
                                                                                     feces--Viscera are removed 
                                                                                     intact.                    
Final Wash...........................   X             --growth of pathogens         --Final wash: Temperature:  
                                                       through insufficient wash.    90-100 deg.F Pressure: 345-
                                                                                     2070 kpa (50-300 psi)--    
                                                                                     Steam Pasteurization:      
                                                                                     Temperature: 195 deg.F or  
                                                                                     greater at surface Dwell   
                                                                                     time: 5-15 seconds in      
                                                                                     cabinet.                   
Chilling.............................   X             --growth of pathogens.......  --Surface temperature 40 deg.F as soon as 
                                                                                     possible--Carcasses spaced 
                                                                                     a minimum of 1 inch apart. 
Receiving-Packaging Materials and Non        X        --contamination from          Letters of guarantee on file
 Beef Supplies.                                        deletious chemicals present   for all packaging materials/
                                                       in the packaging materials.   non-poultry supplies used  
                                                                                     by the establishment.      
Storage-Non Beef Supplies............             X   --contamination of stored     Examine to ensure no visible
                                                       packing materials/supplies    foreign material on/in non-
                                                       from foreign material.        poultry supplies or        
                                                                                     packaging materials.       
----------------------------------------------------------------------------------------------------------------

Section IV

Table 9.--Poultry Slaughter Hazards and Controls
Use of Information
    This section contains examples of common process steps in poultry 
slaughter. With each processing step, shown in the first column, you 
will find an ``X'' in the next three columns to tell you if there is a 
Biological hazard in column 2, a Chemical hazard in column 3, or a 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for your plant's poultry slaughter 
process.

[[Page 38909]]



                                           Table 9.--Poultry Slaughter                                          
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
    Poultry slaughter: examples of                        chemical, or physical        Controls or preventive   
           processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Scalding.............................   X             --contamination from          --Fresh water input to      
                                                       scalding medium.              achieve a minimum of 1     
                                                                                     quart per bird             
                                                                                    --Temperature of the scald  
                                                                                     water maintained at        
                                                                                     appropriate levels (e.g.,  
                                                                                     126 deg.F)      
                                                                                    --Maintain counterflow      
                                                                                     scalding unit function     
                                                                                    --Post scald wash has       
                                                                                     sufficient pressure and    
                                                                                     volume to cover carcass    
                                                                                     with fresh (potable) water 
                                                                                     spray                      
                                                                                    --Overflow volumes are at   
                                                                                     required amounts           
Offline Procedures...................   X             --cross contamination from    Follow approved offline     
                                                       intestinal contents/exudate.  plant procedures for       
                                                                                     handling airsacculitis     
                                                                                     salvage and reprocessing   
                                                                                     for contamination (e.g., an
                                                                                     airsac salvage program that
                                                                                     transfers the carcasses to 
                                                                                     another station where the  
                                                                                     thigh, drumstick, wing tip,
                                                                                     and first wing section are 
                                                                                     salvaged and washed with   
                                                                                     chlorinated water).        
Final Wash...........................   X             --growth of pathogens.......  --A final water wash with   
                                                                                     appropriate levels of      
                                                                                     chlorinated water (e.g. 20-
                                                                                     50 ppm residual chlorine in
                                                                                     the water).                
                                                                                    --Sufficient water volume   
                                                                                     and pressure for equipment 
                                                                                     operation and sufficient   
                                                                                     dwell time in the final    
                                                                                     washer to remove visible   
                                                                                     contamination on internal  
                                                                                     and external surfaces of   
                                                                                     the carcass.               
Chilling-Carcass.....................   X             --growth of pathogens.......  Deep breast muscle          
                                                                                     temperature of carcass is  
                                                                                      40 deg.F within
                                                                                     the specified time from    
                                                                                     slaughter for the class of 
                                                                                     poultry.                   
                                                                                    --Maintain an adequate      
                                                                                     chlorine level in the      
                                                                                     overflow water of in-line  
                                                                                     immersion chillers (e.g.,  
                                                                                     20-50 ppm residual chlorine
                                                                                     in the incoming water).    
                                                                                    --Maintain proper water flow
                                                                                     rates (input/overflow) for 
                                                                                     continuous chillers per    
                                                                                     USDA requirements (not less
                                                                                     than \1/2\ gallon of fresh 
                                                                                     water per frying chicken   
                                                                                     with continuous overflow). 
                                                  X   --contamination from foreign  Product entering (prechill) 
                                                       material.                     and exiting (postchill) the
                                                                                     chiller system meets the   
                                                                                     criteria for defects per   
                                                                                     USDA requirements (e.g. the
                                                                                     limits are not exceed for  
                                                                                     the number and size of     
                                                                                     extraneous materials found 
                                                                                     during the postchill       
                                                                                     examination-9 CFR Sec.     
                                                                                     381.76).                   
Chilling-Giblet/Neck.................   X             --growth of pathogens.......  --Temperature and fresh     
                                                                                     water input sufficient to  
                                                                                     meet USDA requirements for 
                                                                                     giblets and necks.         
                                                                                    --Chlorination of giblet    
                                                                                     chiller water at           
                                                                                     appropriate levels for     
                                                                                     giblets and necks [e.g.,   
                                                                                     giblets must be chilled to 
                                                                                     40 deg.F within 2 hours    
                                                                                     from removal from other    
                                                                                     viscera/fresh water intake 
                                                                                     not less than 1 gallon per 
                                                                                     40 frying chickens         
                                                                                     processed-9 CFR Sec.       
                                                                                     381.66 (c)(5)].            
                                                  X   --contamination from foreign  --Visually free of hazardous
                                                       material.                     foreign material.          
                                                                                    --Defects on poultry giblet 
                                                                                     and necks meet USDA        
                                                                                     requirements (e.g., each   
                                                                                     carcass must be observed   
                                                                                     for conformance against pre
                                                                                     and post chill criteria,   
                                                                                     including unidentified     
                                                                                     foreign materials-MPI      
                                                                                     Regulations 381.76).       

[[Page 38910]]

                                                                                                                
Cut-Up/Boning/Packaging/ Labeling....   X             --growth of pathogens.......  Temperature of product does 
                                                                                     not exceed 55 deg.F during 
                                                                                     further or second          
                                                                                     processing.                
                                                                                    --Movement of product       
                                                                                     through these areas and    
                                                                                     into the cooler is timely  
                                                                                     and efficient.             
                                                                                    --A mid-shift cleanup of the
                                                                                     area(s) is performed if the
                                                                                     room temperature is not    
                                                                                     maintained at or below 50  
                                                                                     deg.F.                     
                                                                                    --Packaging/labeling        
                                                                                     materials that come into   
                                                                                     direct contact with product
                                                                                     are intact.                
Receiving-Packaging Materials and Non        X        --contamination from          Letters of guarantee are on 
 Poultry Supplies.                                     deleterious chemicals         file for all packaging     
                                                       present in the packaging      materials/non-poultry      
                                                       materials.                    supplies used by the       
                                                                                     establishment.             
Storage-Non Poultry Supplies.........             X   --contamination of stored     Examine to ensure no visible
                                                       packing materials/supplies    foreign material on/in non-
                                                       from foreign material.        poultry supplies or        
                                                                                     packaging materials.       
----------------------------------------------------------------------------------------------------------------



Section V

Table 10.--Red Meat (Swine) Slaughter Hazards and Controls
Use of Information
    This section contains examples of common process steps in swine 
slaughter. With each processing step, shown in the first column, you 
will find an ``X'' in the next three columns to tell you if there is a 
Biological hazard in column 2, a Chemical hazard in column 3, or a 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for your plant's swine slaughter process.

                                      Table 10.--Red Meat Slaughter: Swine                                      
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
Red meat slaughter-swine: Examples of                     chemical, or physical        Controls or preventive   
           processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Scalding.............................   X         X   --contamination from          Plant time/temperature      
                                                       scalding medium.              limits for scalding (e.g., 
                                                                                     although it may vary with  
                                                                                     facilities, a temperature  
                                                                                     of 138 to 140 deg.F is     
                                                                                     usually satisfactory).     
                                                                                    --Carcasses should remain in
                                                                                     scalding tanks long enough 
                                                                                     to loosen hair (excessive  
                                                                                     time or temperature results
                                                                                     in carcass cooking).       
                                             X   ...  --contamination with          --USDA-FDA approved chemical
                                                       chemicals..                   concentration not to exceed
                                                                                     manufacturer's             
                                                                                     recommendations.           
Dehairing............................   X   ...  ...  --contamination and growth    --Time/temperature          
                                                       of microorganisms due to      determined by plant-       
                                                       breaking of the skin from     specific testing results to
                                                       overexposure to the           remove visible hair to an  
                                                       dehairer.                     acceptable level without   
                                                                                     breaking skin.             
Evisceration.........................   X   ...  ...  --cross contamination from    --Remove all viscera intact.
                                                       equipment/utensils.          --Contaminated equipment    
                                                      --contamination from           will be clean and sanitized
                                                       stomach, intestines, and/or   before being used again.   
                                                       bladder contents.            --Training program for all  
                                                      --contamination from           employees, to include      
                                                       employee handling.            personal hygiene, product  
                                                                                     handling procedures, and   
                                                                                     sanitary dressing          
                                                                                     procedures.                
Trimming.............................   X   ...  ...  Stick wound has not been      Remove all visible stick-   
                                                       removed..                     wound related defects.     
Chilling.............................   X   ...  ...  --growth of pathogens.......  --Cool surface temperature  
                                                                                     to 40 deg. as soon as      
                                                                                     possible.                  
Receiving-Packaging Materials and Non  ...   X   ...  --contamination from          Letters of guarantee are on 
 Swine Supplies.                                       deleterious chemicals         file for all packaging     
                                                       present in the packaging      materials/non-poultry      
                                                       materials.                    supplies used by the       
                                                                                     establishment.             
Storage-Non Swine Supplies...........  ...        X   --contamination of stored     Examine to ensure no visible
                                                       packing materials/supplies    foreign material on/in non-
                                                       from foreign material.        poultry supplies or        
                                                                                     packaging materials.       
----------------------------------------------------------------------------------------------------------------


[[Page 38911]]



Section VI

Table 11.--Ingredient Hazards and Ingredient-Related Hazards
Use of Information
    This section contains an alphabetical list of ingredients commonly 
used in making meat and poultry products. For each entry you will find 
the name of the ingredient in the first column, and an ``X'' in the 
next three columns to tell you if there is a Biological hazard in 
column 2, Chemical hazard in column 3, or Physical hazard in column 4. 
Column 5 describes the hazard(s), and the last column lists some 
relevant controls or preventive measures. This table should be used in 
conjunction with the list of ingredients developed by your HACCP team 
for the products produced by the process under consideration.
    The HACCP team may find that a particular ingredient does not 
present the hazard identified in these tables. The presence or absence 
of a hazard can be influenced by the ingredient source and company. 
Also, Ingredient Specifications, provided by the supplier to the 
establishment, may give details on the material/ingredient being sold, 
including statements that the materials/ingredients are food grade and 
are free of harmful components. For example, the ingredient 
specifications for dried legumes might state that there will be fewer 
than 5 small rocks or stones per 10 pound bag and that no harmful 
pesticides were used in the growing process.

                                          Table 11.--Ingredient Hazards                                         
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
        Examples of ingredient          B    C    P   chemical, or physical hazard     Controls or preventive   
                                                           for the ingredient                 measures          
----------------------------------------------------------------------------------------------------------------
Acidifiers...........................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Anticoagulants.......................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Antifoaming agents...................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/ provider
                                                                                     ingredient specifications. 
Antioxidants.........................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Batter/Breading......................   X   ...   X   --growth of pathogens due to  --Temperature controls for  
                                                       improper storage and          use                        
                                                       handling.                    --Ingredient specification  
                                                      --foreign material             sheet identifying the      
                                                                                     required parameters the    
                                                                                     ingredient must meet.      
                                                                                    --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Beef (fresh, frozen).................   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper storage and          be 40 degrees F or less at 
                                                       handling.                     receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Binders/Extenders....................  ...   X    X   --foreign material..........  --Ingredients purchased     
                                                                                     under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/ provider
                                                                                     ingredient specifications. 
Bleaching agents.....................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/ provider
                                                                                     ingredient specifications. 
Blood................................   X   ...  ...  --growth of pathogens from    --Ingredient specification  
                                                       improper handling and         sheet identifying the      
                                                       storage.                      required parameters the    
                                                                                     ingredient must meet.      
                                                                                     --Where applicable,        
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
                                                                                     --Meet appropriate temp.   
Boneless beef........................   X   ...   X   --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                       --foreign particle            --Product must meet        
                                                       contamination, e.g., metal    establishment purchase     
                                                       fragments or bone.            specifications.            
                                                                                     --Product must be produced 
                                                                                     under a HACCP plan.        
                                                                                     --Visual examination of    
                                                                                     product for foreign        
                                                                                     materials.                 

[[Page 38912]]

                                                                                                                
Cooked beef..........................   X   ...   X   --growth of pathogens due to  --Receiving temperature of  
                                                       improper handling and         product must be frozen or  
                                                       storage.                      refrigerated at 40 degrees 
                                                       --foreign particle            F or below.                
                                                       contamination, e.g., metal    --Product must be received 
                                                       fragments or bone particles   from an approved supplier  
                                                       in boneless beef.             who produces the product   
                                                                                     under a HACCP plan.        
                                                                                     --Visual examination of    
                                                                                     product for foreign        
                                                                                     materials upon receipt.    
Cooked poultry.......................   X   ...   X   --growth of pathogens due to  --Receiving temperature of  
                                                       improper handling and         product must be frozen or  
                                                       storage.                      refrigerated at 40 degrees 
                                                       --foreign particle            F or below.                
                                                       contamination, e.g., bone     --Product must be received 
                                                       particles in boneless         from an approved supplier  
                                                       poultry.                      who produces the product   
                                                                                     under a HACCP plan.        
                                                                                     --Product must be          
                                                                                     organoleptically acceptable
                                                                                     at receipt.                
Cooked pork..........................   X   ...   X   --growth of pathogens due to  --Receiving temperature of  
                                                       improper handling and         product must be frozen or  
                                                       storage.                      refrigerated at 40 degrees 
                                                       --foreign particle            F or below.                
                                                       contamination, e.g., bone     --Product must be received 
                                                       particles in boneless pork.   from an approved supplier  
                                                                                     who produces the product   
                                                                                     under a HACCP plan.        
                                                                                     --Product must be          
                                                                                     organoleptically acceptable
                                                                                     at receipt.                
Coloring agents (natural)............  ...   X   ...  --Toxicological effect if     --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                     --Ingredients purchased    
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Coloring agents (artificial).........  ...   X   ...  --Toxicological effect if     --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Curing agents........................  ...   X   ...  --Toxico logical effect if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Curing accelerators..................  ...   X   ...  ---toxicological effect if    --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Dairy products.......................   X   ...   X   --growth of pathogens due to  --Temperature control.      
                                                       improper handling and        --Ingredient specification  
                                                       storage.                      sheet identifying the      
                                                       --foreign material            required parameters the    
                                                                                     ingredient must meet.      
                                                                                    --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Eggs or egg products.................   X   ...   X   --growth of pathogens due to  --Temperature control.      
                                                       improper handling and        --Ingredient specification  
                                                       storage.                      sheet identifying the      
                                                      --foreign particle             required parameters the    
                                                       contamination, e.g., shell    ingredient must meet.      
                                                       particles in broken eggs.    --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Emulsifying agents...................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Flavoring agents.....................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Fruits...............................  ...   X    X   --contamination from          --Ingredient specification  
                                                       agricultural chemicals.       sheet identifying the      
                                                      --foreign material             required parameters the    
                                                                                     ingredient must meet.      
Honey................................   X   ...   X   --contamination from          --Ingredient specification  
                                                       inherent microorganisms.      sheet identifying the      
                                                      --foreign particle             required parameters the    
                                                       contamination, e.g., dirt,    ingredient must meet.      
                                                       insect parts.                                            
Legumes (dry)........................  ...  ...   X   --foreign particle            --Ingredient specification  
                                                       contamination, e.g., rocks.   sheet identifying the      
                                                                                     required parameters the    
                                                                                     ingredient must meet.      

[[Page 38913]]

                                                                                                                
Mechanically deboned product.........   X   ...   X   --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                      --foreign particle            --Product must meet         
                                                       contamination, e.g., bone     establishment purchase     
                                                       particles.                    specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Mold inhibitors......................  ...   X   ...  --toxicological effect if     --Ingredient specification  
                                                       improper amounts used.        sheet identifying the      
                                                                                     required parameters the    
                                                                                     ingredient must meet.      
Mushrooms............................   X    X    X   --contamination from          --Ingredient specification  
                                                       inherent microorganisms.      sheet identifying the      
                                                      --contamination from           required parameters the    
                                                       agricultural chemicals.       ingredient must meet.      
                                                      --foreign material            --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Nuts.................................   X    X    X   --contamination from          --Ingredient specification  
                                                       inherent microorganisms.      sheet identifying the      
                                                      --contamination from           required parameters the    
                                                       agricultural chemicals.       ingredient must meet.      
                                                      --foreign particle                                        
                                                       contamination, e.g., broken                              
                                                       shells.                                                  
Packaging materials..................  ...  ...   X   --toxicological effects.....  --Use only FDA approved     
                                                                                     packaging materials.       
                                                                                    -- Each lot of packaging    
                                                                                     material must be           
                                                                                     accompanied by a Letter of 
                                                                                     Guarantee in which the     
                                                                                     manufacturer attests to    
                                                                                     compliance with FDA        
                                                                                     requirements.              
Phosphates...........................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Poultry (fresh, frozen)..............   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Pork (fresh, frozen).................   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Proteolytic enzymes--Aspergillus       ...  ...  ...  --toxicological effects if    --Ingredients purchased     
 oryzae, Aspergillus, Flavusoryzae                     limits exceeded.              under a Letter of          
 group, Bromelin, Ficin, Papain.                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Partially defatted products..........   X   ...   X   --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                      --foreign particle            --Product must meet         
                                                       contamination, e.g., metal,   establishment purchase     
                                                       plastic.                      specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Seafood (fresh, frozen)..............   X    X   ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                      --environmental               --Product must meet         
                                                       contamination.                establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Spices/herbs--Sterilized,               X   ...  ...  --contamination from          --Ingredient specification  
 Unsterilized.                                         microorganisms inherent to    sheet identifying the      
                                                       the ingredient.               required parameters the    
                                                      --contamination from           ingredient must meet.      
                                                       agricultural chemicals.                                  
                                                      --foreign material                                        
Sweeteners--Saccharin, Citric acid,    ...  ...  ...  --toxicological effects if    --Ingredients purchased     
 Malic acid, Monoisopropyl citrate,                    limits exceeded.              under a Letter of          
 Phosphoric acid, Monoglyceride                                                      Guarantee.                 
 citrate.                                                                           --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 

[[Page 38914]]

                                                                                                                
Tenderizing agents...................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Variety meats........................   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling, storage,   be 40 degrees F or less at 
                                                       or cleaning.                  receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Vegetables...........................   X    X    X   --growth of pathogens due to  --Ingredient specification  
                                                       improper handling and         sheet identifying the      
                                                       storage.                      required parameters the    
                                                      --contamination from           ingredient must meet.      
                                                       agricultural chemicals.                                  
                                                      --foreign material                                        
----------------------------------------------------------------------------------------------------------------



Section VII

Table 12.--Processing Hazards and Controls
Use of Information
    This section contains a list of processing hazards and controls 
commonly used in making meat and poultry products. They are listed in 
alphabetical order. For each processing step, shown in the 1st column, 
you will find an ``X'' in the next three columns to tell you if there 
is a Biological hazard in column 2, Chemical hazard in column 3, or 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for the products produced during the 
process under consideration.

                                       Table 12.--Processing Step Hazards                                       
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
                                                          chemical, or physical        Controls or preventive   
           Processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Acidifying (also see Pickling,          X   ...  ...  --survival of pathogens due   --Shelf-stable non-heat     
 Brining).                                             to final pH>4.6.              treated acidified product  
                                                                                     must obtain a pH of 4.6 or 
                                                                                     lower.                     
Aging (Meats)........................   X   ...  ...  --growth/survival of          --The temperature of the    
                                                       pathogens from                aging room will not exceed 
                                                       inappropriate storage         40 degrees Fahrenheit.     
                                                       temperatures and humidity    --Product temperature does  
                                                       (inadequate product water     not exceed 40 degrees      
                                                       activity (aw)).               Fahrenheit throughout the  
                                                      --growth of pathogens due to   aging process.             
                                                       rise in the pH due to        --The aging process will not
                                                       development of surface        exceed seven days.         
                                                       molds.                                                   
Boning...............................   X   ...  ...  --contamination by pathogens  --Careful employee practices
                                                       in product accumulations      to make sure that there is 
                                                       (e.g., cutting boards,        no contamination of the    
                                                       conveyor belts, utensils      product.                   
                                                       and other equipment).        --Equipment and utensils are
                                                      --cross-contamination of       washed and sanitized       
                                                       product by equipment/         immediately when           
                                                       utensils contaminated with    contaminated and each time 
                                                       pathogens when cutting        the employee leaves the    
                                                       through a non-apparent        working station.           
                                                       lesion (e.g., abscesses).    --All hot water sanitizers  
                                                                                     are maintained at 180      
                                                                                     degrees Fahrenheit.        
                                                                                    --Processing room           
                                                                                     temperature is maintained  
                                                                                     at 50 degrees Fahrenheit,  
                                                                                     or a midshift cleanup is   
                                                                                     performed within five hours
                                                                                     after operations begin.    
                                                      --contamination from bones,   --A boneless beef re-       
                                                       cartilage/extraneous          inspection procedure will  
                                                       material.                     be established using       
                                                                                     specifications outlined by 
                                                                                     FSIS.                      
Cooling..............................   X   ...  ...  --growth of pathogens due to  Cooked product will be      
                                                       improper temperatures.        cooled according to        
                                                      --germination of spore-        established procedures.    
                                                       forming pathogens due to                                 
                                                       slow chilling (e.g., C.                                  
                                                       perfringens).                                            
Cooking..............................   X   ...  ...  --survival of pathogens due   --Time/Temperature          
                                                       to improper procedures.       combinations are adequate  
                                                                                     to destroy the pathogens of
                                                                                     concern.                   

[[Page 38915]]

                                                                                                                
Drying (Meat)........................   X   ...  ...  --bacterial growth due to     --A water activity will be  
                                                       inadequate control over       specified that in          
                                                       time, temperature and         conjunction with other     
                                                       humidity.                     barriers will inhibit      
                                                                                     growth of pathogenic       
                                                                                     microorganisms (e.g., for  
                                                                                     shelf stable sausage Aw of 
                                                                                     0.91 and a pH of 4.6).     
Filling..............................   X   ...  ...  --recontamination by          --Product will be protected 
                                                       pathogens in product          from contamination during  
                                                       accumulations.                the filling process, and   
                                                      --growth of pathogens due to   product temperature/ time  
                                                       temperature abuse.            will be maintained at or   
                                                                                     below the maximum          
                                                                                     determined to inhibit      
                                                                                     growth of pathogenic       
                                                                                     microorganisms.            
                                       ...   X   ...  --contamination from          --No lubricants or other    
                                                       lubricants.                   chemical contaminants will 
                                                                                     be allowed in or on the    
                                                                                     product.                   
Formulation..........................   X   ...  ...  --contamination by employee   --Careful employee practices
                                                       handling.                     used at all times to make  
                                                      --incorrect formulation        sure that there is no      
                                                      --contamination through        contamination of product.  
                                                       damaged packages.            --Ingredient packages will  
                                                                                     be clean and intact.       
                                                                                    --Ingredients will be added 
                                                                                     to product according to    
                                                                                     requirements outlined 9CR  
                                                                                     Sec.  318.7.               
                                       ...   X   ...  --excessive addition of       --Restricted ingredients    
                                                       restricted ingredients/       will be added to product   
                                                       additives could be toxic to   according to requirements  
                                                       the consumer.                 outlined in the 9CFR Sec.  
                                                                                     317.8.                     
Freezing (Meats).....................   X   ...  ...  --survival of parasites due   --Rapid cooling and         
                                                       to improper time/             freezing.                  
                                                       temperature application.                                 
                                                      --growth of pathogens due to                              
                                                       temperature abuse.                                       
Grinding.............................   X   ...  ...  --contamination by employee   --Careful employee practices
                                                       handling.                     to make sure that there is 
                                                      --recontamination by           no contamination of        
                                                       pathogens in product          product.                   
                                                       accumulations.                --Product will not be      
                                                                                     allowed to accumulate at   
                                                                                     the end of the grinder.    
                                                                                    --The temperature of the    
                                                                                     grinding room will be      
                                                                                     maintained at 50 degrees   
                                                                                     Fahrenheit.                
Grinding.............................  ...   X   ...  --contamination from          --Food grade lubricants will
                                                       lubricants.                   be used on areas of the    
                                                                                     machinery where a potential
                                                                                     for product contamination  
                                                                                     exists.                    
                                       ...  ...   X   --contamination from          --All boneless product will 
                                                       extraneous material.          be re-inspected before     
                                                                                     being loaded into the      
                                                                                     grinder.                   
Handling and Inspecting of Empty        X    X    X   --recontamination through     --Packaging materials and   
 Containers and Packaging Materials.                   damaged or soiled             empty containers will be   
                                                       containers/packaging          protected from             
                                                       material.                     contamination during their 
                                                                                     storage and handling.      
                                                                                    --No materials or containers
                                                                                     that appear to be          
                                                                                     contaminated with hazardous
                                                                                     foreign material will be   
                                                                                     used.                      
Mechanical Separating................   X   ...  ...  --growth of pathogens.......  --Product holding and       
                                                                                     cooling requirements       
                                                                                     outlined in 9CFR 318.18    
                                                                                     will be followed.          
                                                  X   --contamination from bone,    --The finished product will 
                                                       cartilage fragments.          meet the standards outlined
                                                      --contamination from           in 9CFR 319.5 for bone     
                                                       extraneous material.          particles and calcium.     
Packaging (also see Modified            X    X    X   --contamination from          --Closure and/or machine    
 Atmosphere Packaging, Vacuum                          packaging material.           specifications sufficient  
 Packaging Seaming, Sealing).                         --contamination through        to ensure adequate barrier 
                                                       damaged containers.           formation.                 
                                       ...  ...   X   ............................  --No detectable foreign     
                                                                                     material will be allowed in
                                                                                     or on the product or       
                                                                                     immediate product          
                                                                                     containers.                
Peeling..............................   X   ...  ...  --contamination by pathogens  --Careful employee practices
                                                       in product accumulations.     to make sure that there is 
                                                      --contamination from           no contamination of        
                                                       employee handling.            product.                   
                                                                                    --Product will not be       
                                                                                     allowed to accumulate in/on
                                                                                     peeling equipment.         
                                       ...  ...   X   --contamination from harmful  --Peeling equipment will be 
                                                       extraneous material.          maintained in a proper     
                                                                                     operating condition. No    
                                                                                     foreign material in the    
                                                                                     finished product.          

[[Page 38916]]

                                                                                                                
Receiving............................   X   ...  ...  --contamination through       --Product must be received  
                                                       damaged containers.           in sound containers and at 
                                                      --growth of pathogens due to   temperatures appropriate   
                                                       inappropriate storage         for the type of product.   
                                                       conditions (temperature,                                 
                                                       humidity).                                               
                                                      --growth of pathogens due to                              
                                                       temperature abuse.                                       
                                                      --contamination from                                      
                                                       receiving equipment (pumps,                              
                                                       hoses).                                                  
                                       ...   X   ...  --cross-contamination from    --Product must be received  
                                                       non-food chemicals.           in sound containers and be 
                                                                                     accompanied by a letter of 
                                                                                     guarantee from the supplier
                                                                                     if such letter is not on   
                                                                                     file.                      
                                       ...   X   ...  --contamination from          --Product must be received  
                                                       hazardous extraneous          in sound containers and be 
                                                       material (wood, nails from    accompanied by a letter of 
                                                       pallets, plastic pieces).     guarantee from the supplier
                                                                                     if such letter is not on   
                                                                                     file.                      
Retorting............................   X   ...  ...  --inadequate application of   --A thermal process specific
                                                       scheduled process.            to the product, container  
                                                                                     type and size, and         
                                                                                     retorting system must be in
                                                                                     use. The initial product   
                                                                                     temperature and any        
                                                                                     critical factors specified 
                                                                                     for the thermal process    
                                                                                     must also be controlled.   
                                                                                     Specified retort come up   
                                                                                     procedures will be         
                                                                                     followed.                  
Reworking............................   X   ...  ...  --contamination by employee   --Careful employee practices
                                                       handling.                     to make sure that there is 
                                                      --contamination by pathogens   no contamination of        
                                                       in product accumulations.     product.                   
                                                                                    --Room temperature of       
                                                                                     storage coolers will not   
                                                                                     exceed 40 degrees          
                                                                                     Fahrenheit.                
                                       ...  ...   X   --contamination foreign       --Careful employee practices
                                                       material.                     to make sure that there is 
                                                                                     no contamination of        
                                                                                     product.                   
Shipping.............................   X   ...  ...  --growth due to improper      --Product will not be       
                                                       temperatures.                 shipped unless it is 40    
                                                                                     degrees Fahrenheit or less.
                                                                                    --Product will not be loaded
                                                                                     into transport vehicles if 
                                                                                     the trailer temperature    
                                                                                     exceeds 40 degrees         
                                                                                     Fahrenheit.                
                                       ...  ...   X   --contamination from          --All product packages will 
                                                       hazardous extraneous          be intact before shipping. 
                                                       material through damaged     --All transport vehicles    
                                                       packages.                     will be cleaned after each 
                                                                                     use and before loading of  
                                                                                     product.                   
Thawing..............................   X   ...  ...  --growth of pathogens due to  --Thawing Room temperature  
                                                       improper temperatures.        will not exceed 50 degrees 
                                                                                     Fahrenheit.                
----------------------------------------------------------------------------------------------------------------



Section VIII

REFERENCES

Hazard Analysis Critical Control Point Systems

Agriculture Canada. Food Safety Enhancement Program--Implementation 
Manual. Nepean, Ontario, Canada.
HACCP: The Hazard Analysis and Critical Control Point System in the 
Meat and Poultry Industry. 1994. American Meat Institute Foundation. 
Washington, D.C.
International Commission on Microbiological Specification for Foods. 
1989. ``Microorganisms in Foods 4. Application of hazard analysis 
and critical control point (HACCP) system to ensure microbiological 
safety and quality.'' Blackwell Scientific Publications, Boston.
National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF).
March 20, 1992--Hazard Analysis and Critical Control Point System.
Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for Foods
(NACMCF). June 1993--Report on Generic HACCP for Raw Beef. Food
Micr. 10: 449-488.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles 
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis 
Critical Control Point Programs.'' A Workshop Manual. The Food 
Processors Institute. Washington, D.C.
Tompkin, R.B. 1990. The Use of HACCP in the Production of Meat and 
Poultry Products. J. of Food Protect. 53(9): 795-803.
Tompkin, R.B. 1995. The use of HACCP for producing and distributing 
processed meat and poultry products. In Advances in Meat Research. 
Volume 10. Hazard Analysis Critical Control Point (HACCP) in Meat, 
Poultry and Seafoods. Chapman & Hall (In Press).

Foodborne Illnesses

Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks in 
the United States, 1973-1987: Pathogens, vehicles, and trends. J. 
Food Protect. 53: 804-817.
Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks, 5-
year summary, 1983-1987. J. Food Protect. 53: 711.
Council for Agricultural Science and Technology. ``Risks Associated 
with Foodborne Pathogens.'' February 1993.

[[Page 38917]]

Oblinger, J.L., ed. 1988. Bacteria Associated with Foodborne 
Illnesses, A Scientific Status Summary by the Institute of Food 
Technologists Expert Panel on Food Safety and Nutrition. Food 
Technol. 42(4).
Padhye, N.V.; Doyle, M.P. 1992. E. Coli O157:H7 Epidemiology, 
pathogenesis, and methods for detection in food. J. Food Prot. 
55:55-565.
Schuchat, A., Swaminathan, B. and Broome, C.V. 1991. Epidemiology of 
human listeriosis. Clin. Microbiol. Rev. 4: 169-183.
Tauxe, R.V., ``Epidemiology of Camplyobacter jejuni infections in 
the United States and other Industrialized Nations,'' In Nachamkin, 
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and 
Future Trends, 1994, chapter 2, pages 9-19.
Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth, I.K. 
1988. Campylobacter isolates in the United States, 1982-1986. In, 
CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS-2) : 1-13.
Todd, E. 1990. Epidemiology of Foodborne Illness: North America. The 
Lancet 336:788.

Microbiological, Chemical, and Physical Hazards

Corlett, D.A., Jr. and R.F. Steir. 1991. Risk assessment within the 
HACCP system. Food Control 2:71-72.
Environmental Protection Agency. 1992. Tolerances for Pesticides in 
Foods. Title 40, Code of Federal Regulations, Part 185. U.S. 
Government Printing Office, Washington, DC.
FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington, DC.
FDA. 1994. Fish and Fishery Products Hazards and Control Guide--Get 
Hooked on Seafood Safety. Office of Seafood, Washington, DC.
HACCP: The Hazard Analysis and Critical Control Point System in the 
Meat and Poultry Industry. 1994. American Meat Institute Foundation, 
Washington, DC.
International Commission on Microbiological Specification for Foods. 
1989. ``Microorganisms in Foods 4. Application of hazard analysis 
and critical control point (HACCP) system to ensure microbiological 
safety and quality.'' Blackwell Scientific Publications, Boston.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles 
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis 
Critical Control Point Programs.'' A Workshop Manual. The Food 
Processors Institute. Washington, DC.
USDA, 1994. Domestic Residue Data Book: 1993. USDA, FSIS, 
Washington, DC.
USDA, 1994. List of Propriety Substances and Nonfood Compounds 
Authorized for Use under USDA Inspection and Grading Programs. USDA, 
FSIS, Washington, DC.
USDA, 1995. National Residue Program Plan: 1995. USDA, FSIS, 
Washington, DC.

Internet Home Pages

Agriculture Canada/http://aceis.agr.ca
Food Law Sites/http://www.fsci.umn.edu/FoodLaw/foodlaw.html
HACCP95/http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html
Center for Disease Control/http://fftp.cdc.gov/pub/mmwr/MMWRweekly
Material Safety Data Sheets/http://listeria.nwfsc.noaa.gov/msds.html
U.S. Food and Drug Administration/http://vm.cfsan.fda.gov/list.html 
Bad Bug Book
U.S. Department of Agriculture/http://www.usda.gov

Appendix E--FSIS Sample Collection Guidelines and Procedure for 
Isolation and Identification of Salmonella from Raw Meat and Poultry 
Products

Introduction

    This sampling protocol has been prepared to support the Pathogen 
Reduction/HACCP Regulation. FSIS will be conducting a Salmonella 
testing program in support of this regulation. The regulation does not 
require establishments to conduct their own testing for Salmonella. 
However, for those who choose to conduct their own Salmonella testing 
program, the protocol outlined in this document provides detailed 
instruction for sample collection and analysis that are the same as 
those used in the FSIS Salmonella testing program for raw meat and 
poultry products.
    This protocol incorporates the use of a non-destructive sampling 
technique for sample collection of raw beef and swine carcasses. These 
techniques have been evaluated by the Agricultural Research Service and 
have been designed to give comparable results to the FSIS Nationwide 
Microbiological Baseline Data Collection Programs' excised tissue 
samples. We are continuing to improve the sponging techniques and 
welcome comments. This technique will be closely monitored during the 
first year of prevalence phase Salmonella testing. Carcass sampling for 
broiler and turkey carcasses remain the nondestructive whole bird rinse 
which was used in the Baseline Programs. Ground product sampling 
involves collecting approximately \1/2\ pound of the product.
    The analytical methods section of this protocol details the 
cultural procedures currently in use by FSIS/USDA for the examination 
of raw meat and poultry products for Salmonella. Any screening method 
under consideration for Salmonella testing must meet or exceed the 
following performance characteristics: sensitivity = 97%, 
specificity 96%, false-negative rate = 3%, false-positive 
rate 4%.

Guidelines for Sample Collectors/Microbiologists

Pre-Sampling Preparation
    Prior to collecting samples, the individual designated for sample 
collection should compile a written establishment-specific sample 
collection protocol for microbiological analysis. This protocol should 
include a check list for tasks to be performed prior to sample 
collection, materials needed for sample collection, random selection 
procedures, where the samples will be analyzed (on-site versus off-
site), and other information that will aid the sample collector. 
Sampling supplies, such as sterile gloves, sterile sampling solutions, 
hand soap, sanitizing solution, etc., as well as specific materials 
needed for sampling different carcass types (i.e., specimen sponges in 
bags, if sampling cattle or swine carcasses), will need to be 
assembled.
    For cattle and hog carcass sampling, a template will be needed to 
mark off the area to sample (Figure 1). The template can be made of 
metal or aluminum foil, brown paper, etc. From a sheet larger than the 
area to be sampled, cut out a 10 cm (3.94 inches) x 10 cm square for 
sampling cattle or a 6 cm x 10 cm rectangle for swine carcass sampling. 
If a reusable metal template is used, it will need to be sanitized with 
an approved sanitizing solution (e.g. hypochlorite (bleach) solution or 
alcohol). However, the template needs to be dry before placing it on 
the carcass. Aluminum foil or paper templates can be used once and 
discarded. The foil for the template should be stored in a manner to 
prevent contamination. Since the area enclosed by the template will be 
sampled, take care not to touch this area with anything other than the 
sampling sponge. Using dirty or contaminated material may lead to 
erroneous results. If an autoclave is available, paper or aluminum foil 
templates can be wrapped in autoclavable paper and sterilized.
    The sterile sampling solution, Buffered Peptone Water (BPW), can be 
stored at room temperature. However, at least one day prior to sample 
collection, check solutions for absence of cloudiness and/or turbidity 
and place the number of containers of sampling solution (BPW) that will 
be needed for the next day's sampling in the refrigerator. DO NOT use 
solutions that are cloudy, turbid, or contain particulate matter.
    To obtain the most accurate results, samples should be analyzed as 
soon after collection as possible. However, if samples must be 
transported to an off-site laboratory, the samples need to be

[[Page 38918]]

maintained at refrigeration temperatures until transport, then shipped 
refrigerated via an overnight delivery service to the laboratory 
performing the analysis. Samples analyzed off-site must be picked up by 
the overnight courier the SAME calendar day the sample is collected. 
The sample must arrive at the laboratory no later than the day after 
the sample is collected. Samples shipped to an outside laboratory must 
be analyzed no later than the day after collection. The following 
section gives information on shipping containers and transporting 
samples to off-site facilities.

Shipping Containers and Coolant Packs

    It is important that samples fit easily into the shipping so that 
the sample bags do not break.
    Correct use of the refrigerant gel-ice packs and proper packing of 
the shipping container are necessary so that samples arrive at the 
laboratory at an acceptable temperature. Frozen samples or samples 
which are too warm are not considered valid and must not be analyzed. 
Some bacteria may be damaged by temperatures that are too cold. 
Temperatures that are too warm can allow bacteria to reproduce. 
Maintaining samples at improper temperatures may cause inaccurate 
sample results.
    The sample should be kept refrigerated, NOT FROZEN, in the shipping 
container prior to pickup by the courier. The shipping container, 
itself, should not be used as a refrigerator. However, multiple samples 
(if needed) for that day may be stored in the open shipping container 
in the cooler or refrigerator.
Random Selection of Carcasses or Ground Product for Sampling
    Samples are to be taken randomly. There are different methods of 
selecting the specific carcass for sampling that could be used but all 
require the use of random numbers. Methods could include: using random 
number tables, drawing cards, using calculator- or computer-generated 
random numbers, etc. When selecting the random numbers, use the 
method(s) currently in use at the establishment for other sampling 
programs, if other programs are currently underway.
    The carcass or ground product for sampling must be selected at 
random from all eligible carcasses. If multiple lines exist, randomly 
select the line for sample collection for that interval. Repeat the 
random selection process for the next sampling interval. Each line 
should have an equal chance of being selected at each sampling 
interval.

Cattle Carcass Selection

    The half-carcasses eligible for sampling should be selected from 
those in the cooler 12 or more hours after slaughter. Both the 
``leading'' and ``trailing'' sides of a carcass should have an equal 
chance of being selected. NOTE: If more than one shift is operating at 
the plant, the sample can be taken on any shift, provided the following 
requirements are met:
    Selection of TIME: Determine the times that carcasses chilled for 
12 or more hours will be on hand. Then randomly select a time for 
collecting samples. If samples are shipped off-site, then take into 
account that the delivery service may have limitations on pickup times.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the half-carcass. This site may be 
located at the transfer chain, grading chain, or a rail that contains 
carcasses that have been chilled 12 hours or more.
    Selection of HALF-CARCASS: At the random time selected, identify a 
half-carcass (selected by your random number method) from the 
predetermined point along the chain (selected cooler site) and then 
count back five (5) half-carcasses and select the next half-carcass 
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection.

Swine Carcass Selection

    The carcasses eligible for sampling should be selected from those 
in the cooler 12 or more hours after slaughter. Every carcass should 
have an equal chance of being selected.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:

    Selection of TIME: Determine the times that carcasses chilled for 
12 or more hours will be on hand. Then randomly select a time for 
collecting samples. If samples are shipped off-site, then take into 
account that the delivery service may have limitations on pickup times.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the carcass. This site may be located at 
the transfer chain, or a rail that contains carcasses that have been 
chilled 12 hours or more. If there are multiple sites of the same kind, 
select one at random.
    Selection of CARCASS: At the random time selected, identify a 
carcass (selected by your random number method) from the predetermined 
point along the chain and then count back five (5) carcasses and select 
the next carcass for sampling. The reason for counting back five 
carcasses is to avoid any possible bias during selection.

Poultry Carcass Selection

    The poultry carcasses will be selected at random after chilling, at 
the end of the drip line or last readily accessible point prior to 
packing/cut-up. A WHOLE carcass is required, that is, one that has not 
been trimmed.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:

    Selection of TIME: Determine the times that chilled carcasses will 
be on hand, then randomly select a time for collecting samples. If 
samples are shipped off-site, then take into account that the delivery 
service may have limitations on pickup times.
    Selection of CHILLER: If more than one chiller system is in 
operation at the time of sample collection, the chill tank from which 
the sample is selected must be randomly selected.
    Selection of POULTRY CARCASS: At the random time, identify a 
carcass (selected by your random number method) from the predetermined 
point, and then count back five (5) carcasses and select the next 
carcass for sampling. Exception: If the fifth carcass is not a WHOLE 
(untrimmed) bird, count back an additional five carcasses for sample 
selection. Remember: Each carcass must have an equal chance of being 
selected. The reason for counting back five carcasses is to avoid any 
possible bias during selection.

Raw Ground Product Selection (Beef, Pork, Chicken, Turkey)

    Raw ground product samples will be randomly selected and collected 
after the grinding process and, if possible before any addition of 
spices or seasonings, but prior to final packaging.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:

    Selection of TIME: Determine the times that raw ground product will 
be produced, then randomly select a time for collecting samples. Take 
into account that the overnight delivery service may have limitations 
on pickup times, for determining sample collection time.
    Selection of GRINDER: If more than one grinder is in operation at 
the time of sample collection, the grinder from which the sample is 
selected must be randomly selected.

[[Page 38919]]

Aseptic Techniques/Sampling
    Extraneous organisms from the environment, hands, clothing, sample 
containers, sampling devices, etc., may lead to erroneous analytical 
results. Stringent requirements for microbiological analysis are 
necessary, therefore, use of aseptic sampling techniques and clean 
sanitized equipment and supplies are of utmost importance. The 
following information gives general techniques for aseptic techniques 
that are routinely used during sample collection for microbiological 
analysis.
    There should be an area designated for preparing samples, etc. A 
stainless steel, wheeled cart or table would be useful during sampling. 
A small tote or caddy could be could be easily transported to the 
location of sampling and used for carrying supplies, supporting sample 
bags when adding sterile solutions to sample bags, etc.
    Sterile gloves should be used for collecting samples. The only 
items which may contact the external surface of the glove are the 
exposed sample being collected and/or the sterile sample utensil 
(specimen sponge). Keep in mind that the outside surfaces of the sample 
container are not sterile. Do not handle the inside surface of the 
sterile sample containers. Do not touch anything else. The following 
procedure for putting on sterile gloves can be followed when collecting 
samples:
    (a) Peel open the package of sterile gloves from the top without 
contaminating (touching, breathing on, contacting, etc.) the exterior 
of the gloves.
    (b) Remove a glove by grasping it from the wrist-side opening inner 
surface which is folded. Avoid any contact with the outer surface of 
the glove. Insert the washed and sanitized hand into the glove, taking 
care not to puncture the glove or touch the outside surface of the 
glove.
    (c) Next, follow the same procedure for the hand you will use to 
physically handle the sample, using care not to contaminate the outer 
surface of the glove.
    (d) If at any time you are concerned that a glove may be 
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
    Prior to collecting samples, review steps for sample collection, 
random selection procedure, etc.
    At least one or more days prior to sample collection, check 
sampling solution (BPW) for cloudiness/turbidity and refrigerate if not 
cloudy or turbid. If shipping samples to off-site facility, place 
coolant packs in freezer then pre-chill open shipping in cooler/
refrigerator.
    On the day of sampling, gather all sample collection bags, sterile 
gloves, sanitizer, hand soap, sterile solutions for sampling, and 
specific materials listed under the Materials section of the sample 
collection section for the type of carcass to be sampled.
    Label the sample bags before starting sampling procedure. Use 
permanent ink. If you are using paper labels, it is important that the 
label be applied to the bag at normal room temperature; it will not 
stick if applied in the cooler.
    Outer clothing (frocks, gloves, head gear, etc.) worn in other 
areas of the plant should be removed before entering the sampling area 
or preparing to collect samples. Replace outer clothing removed earlier 
with clean garments (i.e. laboratory coat) that have not been directly 
exposed to areas of the plant outside of the sampling area.
    Sanitize the sample work area surfaces by wiping with a clean 
disposable cloth or paper towel dipped in a freshly prepared 500 ppm 
sodium hypochlorite solution (0.05% sodium hypochlorite) or other 
approved sanitizer which provides an equivalent available chlorine 
concentration. The sample work area surfaces must be free of standing 
liquid before sample supplies and/or product containers are placed on 
them.
    Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include 
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands 
using disposable paper towels.
Specific Sample Collection Procedures
Raw Ground Product

Materials

    1. 2 sterile ziplock-type or stomacher bags or equivalent.
    2. Sterile gloves.
    3. Plastic cable-tie-wrap or thick rubber band for securing bag.

Collection

    Ensure that all supplies are on hand and readily available. Use the 
predetermined random selection procedure to select sample. Samples of 
raw ground product will be collected after the grinding process, and, 
if possible, before the addition of any spices or seasonings, but prior 
to final packaging.
    1. Put on sterile gloves.
    2. Aseptically collect approximately \1/2\ pound of ground product, 
if possible, before the addition of any spices or seasonings, but just 
prior to final packaging. (Sample will be about the size of an orange.) 
Use the sterile sampling bag, taking care not to contaminate the inside 
of the bag with your gloved hand.
    3. Close the bag tightly by twisting the top and securing it with 
the plastic cable-tie-wrap or rubber band or securely closing the 
ziplock-type bag.
    4. Place bagged sample inside a second bag and close the outer bag 
tightly.
    5. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for analysis.
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Cattle Surface Sample Collection Procedure

Materials

1. Sterile specimen sponge in sterile Whirl-Pak bag or 
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile ziplock-type or stomacher bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    A sterile, moistened sampling sponge (which usually come pre-
packaged in a sterile bag) will be used to sample all three sites on 
the swine carcass (ham, belly, and jowls--see Figure 3). It is 
important to swab the sampling areas in the order of least to most 
contaminated to avoid spreading any contamination on the carcass. 
Therefore, swab sampling areas in the sequence indicated in this 
protocol. Use predetermined random selection procedures for selecting 
carcass to be sampled. Remember: samples will be collected from 
carcasses in the cooler 12 hours or more after slaughter. 
Nondestructive surface sampling will be conducted as follows:
    1. Ensure that all bags have been pre-labeled and all supplies are 
on hand, including the sampling template. (An assistant may be helpful 
during the sampling process.)
    2. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the rump sample area (Figure 2) is within easy 
reach from the ladder.
    3. IF a reusable template is used, have the assistant immerse the 
sampling

[[Page 38920]]

template in a sanitizing solution for at least 1-2 minutes. Just prior 
to taking the first sample on the carcass, have the assistant put on a 
pair of gloves (taking care not to contaminate the outer surface of the 
glove with fingers) and retrieve the sampling template from the 
sanitizing solution. Shake excess solution from utensil, then protect 
the portion of the template that will contact the carcass from 
contamination.
    4. Locate the flank, rump, and brisket sampling sites using 
illustrations and directions in Figure 2 (cattle carcass sampling 
locations).
    5. To hydrate the sponge, open the sponge bag. Remove cap from 
sterile BPW bottle, being careful not to touch the bottle opening. 
Carefully pour the contents of the sterile BPW bottle (10 ml) into the 
sponge bag to moisten the sponge.
    6. Close the top of the bag. Use hand pressure from the outside of 
the bag and carefully massage the sponge until it is FULLY HYDRATED 
(moistened).
    7. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag orienting one narrow end of the sponge 
up toward the opening of the bag. Do NOT open the bag or touch the 
sponge with your fingers.
    8. Open the bag containing the sponge, being careful not to touch 
the inner surface of the bag with your fingers. The wire closure at the 
top of the bag should keep the bag open. Set bag aside.
    9. Put on sterile gloves.
    10. Carefully remove the moistened sponge from the bag with your 
sampling hand. Take care to avoid touching the surfaces of the sampling 
sponge.
    11. With the other hand, retrieve the template by the outer edge 
taking care to avoid contaminating the inner edges of the sampling area 
of the template.
    12. Locate the flank sampling area (Figure 2) and place template 
over this
    location.
    13. Hold the template in place with one gloved hand. Take care not 
to contaminate the enclosed sampling area with your hands.
    14. With the other hand, wipe the sponge over the entire enclosed 
area (10 cm x 10 cm) for the sample for a total of approximately 10 
times in the vertical and 10 times in the horizontal directions. The 
pressure for swabbing would be as if you were removing dried blood from 
the carcass. However, the pressure should not be too hard as to crumble 
or destroy the sponge. (Note: The template may need to be ``rolled'' 
from side to side during swabbing since the surface of the carcass is 
not flat. This ensures that the 100 cm\2\ area is enclosed while 
swabbing.)
    15. Repeat steps 13-15 for the brisket area, using the SAME side or 
surface of the sponge used to swab the flank sampling area.
    16. After swabbing the brisket area, transfer the template to the 
same hand holding the sponge. Do not contaminate the inner edges of the 
sampling area of the template.
    17. Climb the ladder or platform, holding onto the handrail with 
the hand NOT used to perform swabbing. Once at a convenient and safe 
height for sampling the rump, transfer template back to ``climbing'' 
hand (hand used to hold onto the rail while climbing the ladder), 
taking care not to contaminate the inner edges of the sampling area of 
the template. Avoid contaminating your sampling hand.
    18. Repeat steps 13-15 for the rump area, using the ``clean'' 
surface or side (the side that was NOT previously used to swab the 
flank/brisket areas).
    19. After swabbing the rump area, carefully place the sponge back 
in the sample bag, taking care not to touch the outside of the sponge 
to the outside of the sample bag.
    20. While holding the handrail, climb down from the ladder.
    21. Expel excess air and fold the top edge of the bag containing 
the sponge 3 or 4 times to close. Secure the bag by folding the 
attached wire tie back against the bag.
    22. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section)
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
Swine Surface Sample Collection Procedure

Materials

1. Sterile specimen sponge in sterile Whirl-Pak bag or 
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile Ziplock-type or stomacher bag
4. Template for a 100 cm2 sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. A 
sterile, moistened sampling sponge (which usually come pre-packaged in 
a sterile bag) will be used to sample all three sites on the swine 
carcass (ham, belly, and jowls--see Figure 3). It is important to swab 
the sampling areas in the order of least to most contaminated to avoid 
spreading any contamination on the carcass. Therefore, swab sampling 
areas in the sequence indicated in this protocol. Use predetermined 
random selection procedures for selecting carcass to be sampled. 
Remember: samples will be collected from carcasses in the cooler 12 
hours or more after slaughter.
    Nondestructive surface sampling will be conducted as follows:
    1. Ensure that all supplies are on hand. (An assistant may be 
helpful during the sampling process.)
    2. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the ham sample area (Figure 3) is within easy reach 
from the ladder.
    3. Immerse the sampling template in a sanitizing solution for at 
least 1-2 minutes. Just prior to swabbing the first sampling site on 
the carcass (step 1), retrieve the sampling template from the 
hypochlorite sanitizing solution. Shake excess solution from utensil, 
then protect the portion of the template (especially the inner edges of 
the sampling area) that will contact the carcass from contamination.
    4. Locate the ``belly'', ham, and jowl sampling sites using 
illustrations and directions in Figure 3 (swine carcass sampling 
locations).
    5. Open the sponge bag by holding the bag at one corner by the wire 
closure (which is usually colored yellow) then tear off the clear, 
perforated strip at the top of the bag. (Do not remove or tear off the 
wire closures). Next, pull apart the two small white tabs on either 
side of the bag to open the mouth of the bag.
    6. Remove cap from sterile BPW tube, being careful not to touch the 
bottle opening. Carefully pour the entire contents of the BPW bottle 
(10 ml) into the sponge bag to moisten the sponge.
    7. Close the top of the bag by pressing the wire closures together. 
Use hand pressure from the outside of the bag and carefully massage the 
sponge until it is FULLY HYDRATED (moistened).
    8. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag positioning one narrow end of the 
sponge up toward the opening of the bag. The whole sponge should still 
be inside the bag.
    9. Open the top of the bag containing the sponge, being careful not 
to touch the inner surface of the bag with your fingers. The wire 
closure at the top of

[[Page 38921]]

the bag should keep the bag open. Set bag aside.
    10. Put on a pair of sterile gloves.
    11. Carefully remove the moistened sponge from the bag with your 
sampling hand. Take care not to touch the surfaces of the sampling 
sponge intended for sampling with sterile glove.
    12. With the other hand, retrieve the template by the outer edge, 
taking care not to contaminate the inner edges of the sampling area of 
the template.
    13. Locate the ``belly'' sampling area (Figure 2) and place the 
template over this location.
    14. Hold the template in place with one gloved hand (Remember, only 
the sponge should touch the sampling area. Take care not to contaminate 
this area with your hands).
    15. With the other hand, wipe the sponge over the entire enclosed 
area (10 cm  x  10 cm) for the sample for a total of approximately 10 
times in the vertical and 10 times in the horizontal directions. The 
pressure for swabbing would be as if you were removing dried blood from 
the carcass. However, the pressure should not be too hard as to crumble 
or destroy the sponge. (Note: The template may need to be ``rolled'' 
from side to side during swabbing since the surface of the carcass is 
not flat. This ensures that the 100 cm2 area is enclosed while 
swabbing.)
    16. After swabbing the ``belly'' area, transfer the template to the 
same hand that is holding the sponge. Do not contaminate the inner 
edges of the sampling area of the template.
    17. Climb the ladder or platform, holding onto the handrail with 
the hand not used for sampling. Once at a convenient and safe height 
for sampling the ham, transfer template back to the ``climbing'' hand 
(hand used to hold onto the rail while climbing the ladder), taking 
care not to contaminate the inner edges of the template. Avoid 
contaminating your sampling hand.
    18. Repeat steps 13-15 for the ham sampling area, using the SAME 
surface of the sponge used to swab the ``belly'' area.
    19. After swabbing the ham area, carefully place the template back 
to the same hand that is holding the sponge. Do not contaminate the 
inner edges of the sampling area of the template.
    20. While holding the handrail with the hand not used for sampling, 
climb down from the ladder.
    21. Transfer the template back to the ``climbing'' hand (hand used 
to hold onto the rail while descending the ladder), taking care not to 
contaminate the inner edges of the template.
    22. Repeat steps 13-15 for the the jowl area, using the ``clean'' 
surface or side (the side that was NOT previously used to swab the 
``belly''/ham areas).
    23. After swabbing the jowl area, carefully place the sponge back 
into the sponge bag. Do not touch the surface of the sponge to the 
outside of the sponge bag.
    24. Press wire closures on the sponge bag together, expel the 
excess air, then fold over the top of the bag 3 or 4 times. Close the 
bag with attached wire by bending the wire tie back against the bag to 
secure it.
    25. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section).
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
Whole Chicken Carcass Rinse Sampling Procedure

Materials

1. 2 Sterile 3500 ml stomacher-type bags or equivalent
2. 400 ml sterile Buffered Peptone Water (BPW)
3. Plastic cable-tie wraps or thick rubber bands or equivalent
4. Sterile gloves

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Ensure 
all sampling supplies are present and have been properly labeled. Use 
predetermined random selection procedure to select a carcass. Birds 
will be collected after the chiller, at the end of the drip line as 
follows:
    1. Gather all supplies for sampling. An assistant may be helpful 
during the sampling process when pouring the rinse solution (BPW) into 
the bag containing the carcass.
    2. Put on sterile gloves. Open a stomacher-type 3500 bag without 
touching the sterile interior of the bag. Rubbing the top edges between 
the thumb and forefinger will cause the opening to gap for easy 
opening.
    3. With one hand, push up through the bottom of the sampling bag to 
form a `glove' over one hand with which to grab the bird, while using 
your other hand to pull the bag back over the hand that will grab the 
bird. This should be done aseptically without touching the exposed 
interior of the bag.
    4. Using the hand with the bag reversed over it, pick up the bird 
by the legs (hocks) through the stomacher bag. (The bag functions as a 
``glove'' for grabbing the bird's legs.) Take care not to contaminate 
the exposed interior of the bag. Allow any excess fluid to drain before 
reversing the bag back over the bird. (Alternately, have an assistant 
hold open the bag. Using your gloved hand, pick up the bird by the 
legs, allow any fluid to drain, and place the bird vent side up into 
the sampling bag.)
    5. Rest the bottom of the bag on a flat surface. While still 
holding the top of the bag slightly open, add the 400 ml of sterile BPW 
to the sterile plastic bag. (Alternately, with the aid of an assistant 
holding the bag open, add the 400 ml of sterile BPW to the bag, pouring 
the solution into the carcass cavity.)
    6. Close the bag and while securely holding the bag, rinse bird 
inside and out using a rocking motion for 30 shakes (approximately one 
minute). This is done by holding the bird through the bottom of the bag 
with one hand and the closed top of the bag with the other hand. Hold 
the bird securely and rock it in an arcing motion, alternating the 
weight of the bird from one hand to the other (motion like drawing an 
invisible rainbow or arch), assuring that all surfaces (interior and 
exterior of the carcass) are rinsed.
    7. Put the bird in the bag on a flat surface. Open the bag.
    8. With a gloved hand, remove the carcass from the bag. Since the 
carcass was rinsed with a sterile solution, it should be returned to 
the chill tank. Be sure not to touch the interior of the bag with your 
gloved hand.
    9. Twist the top of the bag several times (about 4 or 5 turns). 
Fold the twisted portion of the bag to form a loop. Secure the twisted 
loop with the supplied plastic tie-wrap. The tie-wrap should be very 
tight so that the rinse fluid will not spill out. Place the sample bag 
into another bag and secure the opening of the outer bag. [Alternately, 
at least 30 ml of the rinse fluid can be poured into a sterile, leak-
proof sampling container and the container then can be placed in a 
sampling bag for transport to the lab. NOTE: It is important to send at 
least the minimum volume of rinse fluid, since 30 ml of rinse fluid 
will be used for sample analysis. The solution remaining after 
decanting the 30 ml can be poured down the drain]
    10. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis.
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.

[[Page 38922]]

Turkey Carcass Rinse Sampling Procedure

Materials

    1. 1 large sterile 3500 ml stomacher-type or ziplock-type bags or 
equivalent, at least 8''  x  24''
    2. 600 ml sterile, Buffered Peptone Water (BPW)
    3. Plastic cable-tie wraps or thick rubber bands or equivalent
    4. Sterile gloves

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Ensure 
that all supplies are on hand, labeled, and readily available. An 
assistant will be needed to hold the bag for collecting the bird. Use 
the predetermined random selection procedure to select the turkey 
carcass to be sampled. The randomly selected birds will be collected 
after the chiller, at the end of the drip line as follows:
    1. Have an assistant open the large stomacher-type bag (18''  x  
24''). (Rubbing the top edges of the stomacher-type bag between the 
thumb and index finger will cause the opening to gap.) The assistant 
should be ready to receive the turkey carcass.
    2. Put on sterile gloves.
    3. Remove the selected turkey from the drip line by grasping it by 
the legs and allowing any fluid to drain from the cavity.
    4. Place the turkey carcass, vent side up, into a sterile 
Stomacher-type 3500 bag (or equivalent). Large turkeys should be placed 
in a plain, clear polypropylene autoclave bag (ca. 24''  x  30-36''). 
Only the carcass should come in contact with the inside of the bag.
    5. While still supporting the carcass with one hand on the bottom 
of the bag, have the assistant open the bag with the other hand. 
Alternately, the assistant can rest the bottom of the bag on a 
sanitized table and while still supporting the carcass, open the bag 
with the other hand.
    6. Add the 600 ml of sterile BPW to the sterile plastic bag, 
pouring the solution into the carcass cavity of the BPW over the 
exterior of the carcass. Close the bag.
    7. Manipulate the loose neck skin on the carcass through the bag 
and position it over the neck bone area to act as a cushion and prevent 
puncturing of the bag. The assistant will need to support the carcass 
with one hand on the bottom of the bag. Close bag.
    8. Squeeze air from the bag and close top. Take the bag from the 
assistant. Close the bag and while securely holding the bag, rinse bird 
inside and out using a rocking motion for 30 shakes (approximately one 
minute). This is done by holding the carcass through the bag with one 
hand and the closed top of the bag with the other hand. Holding the 
bird securely with both hands, rock in an arcing motion alternating the 
weight of the bird from one hand to the other (motion like drawing an 
invisible rainbow or arch), assuring that all surfaces (interior and 
exterior of the carcass) are rinsed.
    9. Hand the bag back to the assistant.
    10. With a gloved hand, remove the carcass from the bag first 
letting any excess fluid drain back into the bag. Since the carcass was 
rinsed with a sterile solution, it should returned to the chill tank. 
Be sure not to touch the interior of the bag with your gloved hand.
    11. Expel excess air, taking care not to expel any rinse fluid. 
Twist the top of the bag several times (about 4 or 5 turns). Fold the 
twisted portion of the bag to form a loop. Secure the twisted loop with 
the supplied plastic tie-wrap. The tie-wrap should be very tight so 
that the rinse fluid will not spill out.
    12. Place the sample bag into another bag and secure the opening of 
the outer bag. [Alternately, no less than 30 ml of the rinse fluid can 
be poured into a sterile, leak-proof sampling container and placed in a 
sampling bag for transport to the lab. Thirty ml of rinse fluid will be 
used for sample analysis. The solution remaining after decanting the 30 
ml can be poured down the drain]
    13. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis. (See 
Analytical Methods section.)
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
    It is recommended that samples be analyzed on-site (not in the 
plant itself, but in a suitable laboratory). Those samples analyzed on-
site must be analyzed as soon after collection as possible. If no on-
site facilities are available, the samples must be shipped the same 
calendar day as collected, to an outside laboratory. The samples must 
be analyzed the day after collection.
    1. Prechill shipping container by placing the open shipping 
container in the refrigerator at least the day before sampling.
    2. Place the appropriately-labeled double-bagged sample in the 
prechilled shipper in an upright position to prevent spillage. 
Newspaper may be used for cushioning the sample and holding it in the 
upright position. Ensure that the sample is maintained at refrigeration 
temperature to prevent multiplication of any microorganisms present and 
to provide the most accurate results.
    3. Place a corrugated cardboard pad on top of the sample. Next, 
place the frozen gel pack(s) on top of the corrugated pad to prevent 
direct contact of frozen gel packs with the sample. Use sufficient 
frozen coolant to keep the sample refrigerated during shipment to the 
designated laboratory. Insert a foam plug and press it down to minimize 
shipper head space.
    4. Ship sample (via overnight delivery or courier) to the assigned 
laboratory.

Analytical Methods

Equipment, Reagents, and Media Equipment
1. Sterile scalpels, scissors, forceps, knives, spatulas, spoons, ruler 
or template, pipettes, petri dishes, test tubes
2. Sterile Stomacher 3500 bags (or equivalent) or plain, clear 
polypropylene autoclave bags (ca. 24''  x  30-36'')
3. Incubator, 36  1 deg.C
4. Incubator/Water bath, 42  0.5 deg.C
5. A mechanical homogenization device. A Stomacher, used with sterile 
plastic bags, is acceptable. Some laboratories prefer to use a sterile 
Osterizer-type blender with sterilized cutting assemblies and adapters 
for use with sterile Mason jars.
6. Water bath, 48-50 deg.C
7. Glass slides, glass plate marked off in one-inch squares or 
agglutination ring slides
8. Balance, 2000 gram capacity, sensitivity of 0.1 gram
9. Inoculating needles and loops
10. Vortex mixer
11. Sterile sampling sponge and sponge bag
Reagents
1. Iodine solution for TT broth (Hajna)
2. Buffered Peptone Water (BPW) diluent
3. Methyl red reagent
4. O'Meara's V-P reagent, modified
5. Kovac's reagent
6. Ferric chloride, 10% aqueous solution
7. Sterile mineral oil
8. Saline, 0.85%
9. Saline, 0.85% with 0.6% formalin
10. Salmonella polyvalent O antiserum
11. Salmonella polyvalent H antiserum
12. Salmonella individual O grouping sera for groups A-I

[[Page 38923]]

Media
1. Buffered peptone water (BPW)
2. Tetrathionate broth (TT-Hajna)
3. Rappaport-Vassiliadis (RV) broth (4)--Merck Chemical Co., Cat. #7700 
or equivalent
4. Brilliant green sulfa agar (BGS; contains 0.1% sodium sulfapyridine)
5. Double modified lysine iron agar (DMLIA; 2)
6. Triple sugar iron agar (TSI)
7. Lysine iron agar (LIA)
8. MR-VP Medium
9. Tryptone broth
10. Simmons citrate agar
11. Phenol red tartrate agar
12. Motility Medium
13. Christensen's urea agar
14. Carbohydrate fermentation media with Andrade's indicator
15. Decarboxylase test media (Moeller)
16. Malonate broth
17. KCN broth
18. Phenylalanine agar
19. Nutrient gelatin
20. Trypticase soy broth
21. Tryptose broth
Analytical Procedures
Sample Preparation for Analysis
    The diverse nature of the samples which may require analysis (e.g., 
ground product versus a poultry carcass rinse sample) requires separate 
preparation procedures for each sample type.

Raw Ground Product Sample Preparation

    a. Use a sterile spoon or spatula to take portions of product from 
several areas of the sample to prepare a 25 g composite sample in a 
sterile plastic stomacher-type bag or blender jar. Use of a stomacher 
filter bag may facilitate pipetting after pre-enrichment.
    b. Add 225 ml BPW. Homogenize for two minutes in a Stomacher or 
blender.

Beef or Pork Carcass Sponge Sample Preparation

    a. Add 50 ml of BPW to the sample bag containing the sponge to 
bring the total volume to 50 ml. Mix well.

Whole Chicken Carcass Rinse-Fluid Sample Preparation

    a. Remove 30 ml of carcass-rinse fluid and place it in a sterile 
plastic bag or other sterile container.
    b. Add 30 ml of BPW to the sample. Mix well.

Turkey Carcass Rinse-Fluid Sample Preparation

    a. Remove 30 ml of carcass-rinse fluid and place it in a sterile 
plastic bag or other sterile container.
    b. Add 30 ml of BPW to the sample. Mix well.
Detection Procedure
    Sample/BPW suspensions prepared as directed in Sample preparation 
for analysis section (above) are the starting point for this step in 
the protocol. From this point on, sample suspensions of various types 
(e.g., whole bird rinse sample vs. raw ground product) can be treated 
in the same manner.

    Note: If using a screening test, follow manufacturer's 
instruction for enrichment procedures. If an alternate enrichment 
scheme is to be used, verification of the effectiveness of this 
alternate enrichment protocol with the screening test should be 
received from the manufacturer of the screening test or by in-
laboratory testing.

    1. Incubate sample/BPW suspension at 36  1 deg.C for 
20-24 hours.
    2. a. Transfer 0.5 ml of the BPW sample pre-enrichment culture into 
10 ml TT broth.
    b. Transfer 0.1 ml of the BPW sample pre-enrichment culture into 10 
ml RV broth.
    3. a. Incubate the TT enrichment culture at 42  
0.5 deg.C for 22-24 hours.
    b. Incubate the RV enrichment culture at 42  0.5 deg.C 
for 22-24 hours.
    4. Streak each enrichment culture onto both DMLIA and BGS agar 
plates. Do not subdivide plates for streaking multiple samples; streak 
the entire agar plate with a single sample enrichment.
    5. Incubate plates at 36  1 deg.C.
    6. Examine plates after 22-24 hours of incubation. Reincubate 
negative plates and reexamine them the following day.
    7. Select and confirm suspect colonies as described in the sections 
for Isolation procedure through Biochemical testing procedures (below).
Isolation Procedure
    1. Pick typical well-isolated colonies.
    a. BGS. Select colonies that are pink and opaque with a smooth 
appearance and an entire edge surrounded by a red color in the medium. 
On very crowded plates, look for colonies that appear tan against a 
green background.
    b. DMLIA. Select purple colonies with or without black centers. 
Since salmonellae typically decarboxylate lysine and ferment neither 
lactose nor sucrose, the color of the medium reverts to purple.
    2. Select three suspect colonies from each plate. Pick only from 
the surface and center of the colony. Avoid touching the agar because 
these selective media may suppress growth of organisms which are viable 
but not visible; such ``sleeper'' organisms can be picked up from the 
agar surface and carried forward onto media used for confirmation 
tests. If a plate is crowded and there are no well-isolated colonies 
available, restreak from this plate directly onto fresh selective agar 
plates.
Initial Isolate Screening Procedure
    1. Inoculate TSI and LIA slants consecutively with a single pick 
from a colony by stabbing the butts and streaking the slants in one 
operation. If screw-cap tubes are used, the caps must be loosened 
before incubation. Incubate at 36  1 deg.C for 
242 hours.
    2. Examine TSI and LIA slants as sets. Note the colors of butts and 
slants, blackening of the media and presence of gas as indicated by gas 
pockets or cracking of the agar. Note also the appearance of the growth 
on the slants along the line of streak. Discard sets that show 
``swarming'' from the original site of inoculation. Discard sets that 
show a reddish slant in LIA. Isolates giving typical Salmonella spp. 
reactions should be confirmed by serological tests. Examine isolates 
which are suggestive, but not typical of Salmonella spp. by a 
combination of biochemical and serological procedures. Confirm by 
biochemical tests ONLY those isolates that appear typical of 
salmonellae, but do not react serologically. Refer to the following 
chart for assistance in making these determinations.

--------------------------------------------------------------------------------------------------------------------------------------------------------
              Triple sugar iron agar                       Lysine iron agar                   Polyvalent sera                                           
----------------------------------------------------------------------------------------------------------------------            Disposition           
      Butt            Slant             H 2S             Butt             H2S               O                H                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y..............               R                +                P                +                +                +   Salmonella spp.                  
Y..............               R                +                P                +                +                -   B. & M. T.                       
Y..............               R                -                P                -   ...............  ...............  B. & M. T.                       
Y..............               R                -                Y                -                +                +   B. & M. T.\1\                    
Y..............               R                -                Y                -                -   ...............  Discard.                         
Y..............               R                +                Y        ...............  ...............  Discard.                         
Y..............               Y                -              Y/P                -   ...............  ...............  Discard.                         

[[Page 38924]]

                                                                                                                                                        
Y..............               Y                +                P                +   ...............  ...............  B. & M. T.\2\                    
NC.............               NC  ...............  ...............  ...............  ...............  ...............  Discard.                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Y = Yellow; R = Red; P = Purple; B. & M. T. = Biochemical and motility tests; NC = No change in color from uninoculated medium.                        
\1\ Salmonella choleraesuis (rarely found in swine in U.S.).                                                                                            
\2\ Salmonella arizonae.                                                                                                                                


Serological Tests
    All isolates giving TSI and LIA reactions which could be considered 
suggestive of Salmonella should be tested serologically. If the TSI and 
LIA reactions, together with the serological reactions, are indicative 
of Salmonella, confirmation may cease at this point. If, however, 
atypical TSI or LIA results and/or negative serological tests are 
encountered, biochemical testing is mandatory (see Biochemical testing 
procedure, below).
1. O Agglutination Tests
    At a minimum, isolates should be tested with polyvalent O antiserum 
reactive with serogroups A through I. Following a positive reaction 
with polyvalent O antiserum, it is necessary to type the isolate using 
individual Salmonella antisera for O groups A through I. Testing for O 
groups A through I should encompass the majority of the Salmonella 
serotypes commonly recovered from meat and poultry products. 
Occasionally, however, an isolate which is typical of Salmonella 
(biochemically and Poly H serologically) but non-reactive with antisera 
to groups A through I will be recovered; such an isolate should be 
reported as ``Salmonella non A-I'' or ``Salmonella O group beyond I''.
    Follow the manufacturer's instructions enclosed with the antisera. 
Use growth from either the TSI or LIA slant. Test the isolate first 
using polyvalent O antiserum. Do not read agglutination tests with a 
hand lens. If there is agglutination with the saline control alone 
(autoagglutination), identify such an isolate by biochemical reactions. 
If the saline control does not agglutinate and the polyvalent serum 
does, identify the individual O group using the individual Salmonella O 
grouping antisera for groups A through I. Record positive results and 
proceed to H agglutination tests.
2. H Agglutination Tests
    Inoculate Trypticase soy broth or Tryptose broth. Incubate at 36 
 1  deg.C overnight or until growth has an approximate 
density of three on McFarland's scale. Add an equal amount of saline 
containing 0.6% formalin and let set one hour. Remove one ml to each of 
two 13  x  100 mm test tubes. To one of the tubes, add Salmonella 
polyvalent H serum in an amount indicated by the serum titer or 
according to the manufacturer's instructions. The other tube serves as 
an autoagglutination control. Incubate both tubes at 48-50  deg.C in a 
water bath for up to one hour. Record presence or absence of 
agglutination. Alternatively, any other poly H agglutination test may 
be used as long as it gives results equivalent to the conventional tube 
agglutination procedure described above.
Biochemical Testing Procedures
    Biochemical confirmation is only necessary with those isolates 
giving atypical TSI or LIA results and/or negative serological tests. 
Do the minimum number of tests needed to establish that an isolate can 
be discarded or that it is a member of the genus Salmonella. Exhaustive 
testing of any isolate from a sample that has already yielded a 
typical, easily identifiable Salmonella is unnecessary.
    If further testing is necessary, inoculate the following media 
first: Tryptone broth, MR-VP medium, Simmons citrate agar, 
Christensen's urea agar, motility test medium, phenol red tartrate 
agar, and glucose, lactose, sucrose, salicin and dulcitol fermentation 
broths. Incubate at 36  1  deg.C and record reactions the 
following day. Test Tryptone broth with Kovac's reagent for indole 
production in 24 hours and, if negative, again in 48 hours. Do not 
perform the MR-VP test until 48 hours have elapsed. If results are 
ambiguous, repeat MR test after five days of incubation. Hold negative 
carbohydrate fermentation tests for 14 days.
    Refer to ``Edwards and Ewing's Identification of 
Enterobacteriaceae'', 4th Edition (3), for biochemical reactions of 
Enterobacteriaceae and for fermentation media and test procedures.
    Discard all isolates that give positive urea or VP reactions. 
Discard any isolate that has the following combination of 
characteristics: produces gas in glucose, produces indole but not 
H2S, is MR positive, VP negative and citrate negative; such 
organisms are E. coli regardless of ability to ferment lactose in 48 
hours.
    Inoculate additional biochemical tests as necessary to eliminate 
other Enterobacteriaceae. Refer to Edwards and Ewing for details. 
Eliminate Providencia spp. by a positive phenylalanine reaction. 
Eliminate Hafnia alvei on the basis of the following biochemical 
pattern: indole negative; MR negative, and VP and citrate positive 
based on four days of incubation at 25  deg.C; fermentation of 
arabinose and rhamnose; failure to ferment adonitol, inositol, 
sorbitol, and raffinose.
    Alternatively, any other biochemical test system may be used as 
long as it gives results equivalent to the conventional tests.
Quality Control Procedures
    It is recommended that a minimum of three method controls be 
analyzed whenever meat or poultry products are being examined for the 
presence of salmonellae. These controls should include a S. typhimurium 
(H2S positive), S. senftenberg (H2S negative), and an 
uninoculated media control. The inoculum level for the positive 
controls should approximate 30-300 CFU per container of enrichment 
medium. Inoculate positive controls at the end of each day's run. 
Incubate the three controls along with the samples, and analyze them in 
the same manner as the samples. Confirm at least one isolate recovered 
from each positive control sample.
Storage of Isolates
    Do not store isolates on TSI agar because this tends to cause 
roughness of O antigens. For short-term (2-3 months) storage, inoculate 
a nutrient agar slant, incubate at 36  1  deg.C overnight, 
and then store at 4-8  deg.C.
    For long-term storage of isolates, subculture Salmonella isolates 
by stabbing nutrient agar (0.75% agar). Incubate at 36  1 
deg.C overnight, and then seal with hot paraffin-soaked corks. 
Household wax is better than embedding paraffin because it stays 
relatively soft at room temperature making the corks easy to remove. 
Store isolates in the dark at room

[[Page 38925]]

temperature. Such isolates will remain viable for several years.
    Store ``working'' Salmonella stock cultures on nutrient agar 
slants. Transfer stocks monthly, incubate overnight at 36  
1  deg.C, and then store them at 4-8  deg.C.

References

    1. AOAC International. 1995. Official Methods of Analysis of 
AOAC International. P.A. Cunniff, ed. 16th Edition. Gaithersburg, 
MD.
    2. Bailey, J. S., J. Y. Chiu, N.A. Cox, and R.W. Johnston. 1988. 
Improved selective procedure for detection of salmonellae from 
poultry and sausage products. J. Food Protect. 51(5):391-396.
    3. Ewing, W. H. 1986. ``Edwards and Ewing's Identification of 
Enterobacteriaceae'', 4th Edition. Elsevier Science Publishing Co., 
Inc., New York, NY.
    4. Vassiliadis, P. 1983. The Rappaport-Vassiliadis (RV) 
enrichment medium for the isolation of salmonellas: An overview. J. 
Appl. Bacteriol. 54:69-76.

BILLING CODE 3410-DM-P

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[GRAPHIC] [TIFF OMITTED] TR25JY96.018



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[GRAPHIC] [TIFF OMITTED] TR25JY96.019



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[GRAPHIC] [TIFF OMITTED] TR25JY96.020



BILLING CODE 3410-DM-C

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Appendix F--Guidelines for Escherichia coli Testing for Process Control 
Verification in Cattle and Swine Slaughter Establishments

Introduction

    Under the Pathogen Reduction/HACCP Regulation, all slaughter 
establishments will be required to test carcasses for generic E. coli 
as a tool to verify process control. This document outlines the 
sampling and microbial testing that should be followed to meet this 
requirement. It also gives guidance to interpreting your results. This 
document is a supplement to the Regulation, but not a substitute for 
it. Further in-depth details of the program may be found in the 
Regulation. Please provide these guidelines to your company 
microbiologist or testing laboratory in order to help you meet the 
regulatory requirements for generic E. coli testing.

Guidelines for Sample Collectors/Microbiologists

Background
    This sampling protocol has been prepared to support the Pathogen 
Reduction/HACCP Regulation. This protocol incorporates the use of a 
nondestructive sampling technique for sample collection from raw beef 
and swine carcasses. These techniques have been evaluated by the 
Agricultural Research Service and have been designed to give comparable 
results to the FSIS Nationwide Microbiological Baseline Data Collection 
Programs' excised tissue samples. We are continuing to improve the 
sponging techniques and welcome comments. This technique will also be 
used in the FSIS Salmonella testing programs and will be closely 
monitored during the first year of prevalence phase testing.
    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 across the 
nation. It is imperative that all like establishments adhere to the 
same sampling and analysis requirements detailed here, without 
deviation. These sampling and analytical procedures may be directly 
written into your establishment's individual HACCP plan.
    Cattle and swine carcasses must be sampled at the end of the 
slaughter process in the cooler. These sample collection locations are 
the same as those in the FSIS baseline studies, making samples taken 
here comparable to the nationwide baseline performance criteria.
Pre-sampling Preparation
    Sample collection will be carried out by the individual designated 
in the establishment's written protocol for microbiological sampling. 
This protocol should include a check list of tasks to be performed 
prior to sample collection, materials needed for sample collection, 
random selection procedures, where the samples will be analyzed (on-
site versus off-site), and other information that will aid the sample 
collector. As stated previously, this guideline can be a part of the 
plant's sample collection guidelines, but plant specific details and 
procedures will need to be included. Sampling supplies, such as sterile 
gloves, sterile sampling solutions, hand soap, sanitizing solution, 
etc., as well as specific materials needed for sampling different 
carcass types (i.e., specimen sponges in bags and template for sampling 
cattle or swine carcasses), will need to be assembled prior to 
beginning sample collection.
    For cattle and swine carcass sampling, a template will be needed to 
mark off the area to sample. The template can be made of metal or 
aluminum foil, brown paper, flexible plastic, etc. Some disposable 
templates may come sterilized and individually prepackaged. To make a 
reusable template, cut out a 10 centimeters (cm) x 10 cm (3.94 inches x 
3.94 inches) square from a sheet larger than the area to be sampled. 
(See Figure 1). If a reusable template is used, it will need to be 
sanitized with an approved sanitizing solution [e.g., hypochlorite 
(bleach) solution or alcohol]. However, the template needs to be dry 
before placing it on the carcass. Aluminum foil or paper templates can 
be used once and discarded. The foil for the template should be stored 
in a manner to prevent contamination. Since the area enclosed by the 
template will be sampled, take care not to touch this area with 
anything other than the sampling sponge. Using dirty or contaminated 
material may lead to erroneous results. If an autoclave is available, 
paper or aluminum foil templates can be wrapped in autoclavable paper 
and sterilized.
    Sterile sampling solutions, Butterfield's phosphate diluent (BPD), 
can be stored at room temperature. However, at least on the day prior 
to sample collection, check solutions for cloudiness. DO NOT use 
solutions that are cloudy, turbid or contain particulate matter. Place 
the number of containers of sampling solution (BPD) that will be needed 
for the next day's sampling in the refrigerator.
    To obtain the most accurate results, samples should be analyzed as 
soon after collection as possible. However, if samples must be 
transported to an off-site laboratory, the samples need to be 
maintained at refrigeration temperatures until transport, then shipped 
refrigerated via an overnight delivery service to the laboratory 
performing the analysis. Samples analyzed off-site must be picked up by 
the overnight courier the SAME calendar day the sample is collected. 
The sample must arrive at the laboratory the day after the sample is 
collected. Samples shipped to an outside laboratory must be analyzed no 
later than the day after collection. The following section gives 
information on shipping containers and transporting samples to off-site 
facilities.

Shipping Containers and Coolant Packs

    It is important that samples fit easily into the shipping 
containers so that the sample bags do not break. Correct use of the 
refrigerant gel-ice packs and proper packing of the shipping container 
are necessary so that samples arrive at the laboratory at an acceptable 
temperature. Frozen samples or samples which are too warm are not 
considered valid and must not be analyzed. Some bacteria may be damaged 
by temperatures that are too cold, while temperatures that are too warm 
can allow bacteria to reproduce. Maintaining samples at improper 
temperatures may cause inaccurate sample results. The sample should be 
kept refrigerated, NOT FROZEN, in the shipping container prior to 
pickup by the courier service. The shipping container, itself, should 
not be used as a refrigerator. However, multiple samples (if needed) 
for that day may be stored in the open shipping container in the cooler 
or refrigerator.
Sampling frequency
    Sampling frequency for E. coli testing is determined by production 
volume. The required minimum testing frequencies for all but very low 
production volume establishments are shown in Table 1 by slaughter 
species.

                 Table 1.--E. coli Testing Frequencies a                
------------------------------------------------------------------------
                                                                        
Cattle....................................  1 test per 300 carcasses.   
Swine.....................................  1 test per 1,000 carcasses. 
------------------------------------------------------------------------
a Note: These testing frequencies do not apply to very low volume       
  establishments. See Table 2.                                          

Very Low Volume Establishments

    Some establishments may be classified as very low volume 
establishments. The maximum yearly

[[Page 38930]]

slaughter volumes for very low volume establishments are described in 
Table 2.

Table 2.--Maximum Yearly Livestock Slaughter Volumes for Very Low Volume
                             Establishments                             
------------------------------------------------------------------------
                                           Criteria (yearly slaughter   
           Slaughter species                         volume)            
------------------------------------------------------------------------
Cattle................................  Not more than 6,000 head.       
Swine.................................  Not more than 20,000 head.      
Cattle and Swine......................  Not more than 20,000 total, with
                                         not more than 6,000 cattle.    
------------------------------------------------------------------------

    Establishments with very low volumes are to sample the predominant 
species at an initial rate of once per week until at least 13 test 
results have been obtained. Once the initial criteria have been met for 
very low volume establishments (see APPLYING PERFORMANCE CRITERIA TO 
TEST RESULTS), the establishment will repeat the same sampling regime 
once per year, in the 3 month period of June through August, or 
whenever a change is made in the slaughter process or personnel.
Random Selection of Carcasses
    Samples are to be taken randomly at the required frequency (See 
section on Sampling Frequency). For example, given the frequency of 
testing for cattle is 1 (one) test per every 300 cattle slaughtered, 
then if a plant slaughters 150 head of cattle an hour, 1 (one) sample 
will be taken every 2 hours.
    Different methods of selecting the specific carcass for sampling 
could be used, but all require the use of random numbers. Methods could 
include: using random number tables, using calculator- or computer-
generated random numbers, drawing cards, etc. When selecting the random 
numbers, use the method(s) currently in use at the establishment for 
other sampling programs, if other programs are currently underway.
    The carcass for sampling must be selected at random from all 
eligible carcasses. If multiple lines exist, randomly select the line 
for sample collection for that interval. Repeat the random selection 
process for the next sampling interval. Each line should have an equal 
chance of being selected at each sampling interval.

Cattle Carcass Selection

    The half-carcasses eligible for sampling should be selected from 
those in the cooler 12 or more hours after slaughter. Both the 
``leading'' and ``trailing'' sides of a carcass should have an equal 
chance of being selected within the designated time frame (based on the 
sampling frequency for the plant). NOTE: If more than one shift is 
operating at the plant, the sample can be taken on any shift, provided 
the following requirements are met:
    Selection of TIME: Select the time, based on the appropriate 
sampling frequency, for collecting the sample.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the half-carcass. This site may be 
located at the transfer chain, grading chain, or a rail that contains 
carcasses that have been chilled 12 hours or more. If there are 
multiple sites of the same kind, select one at random.
    Selection of HALF-CARCASS: Based on the sampling frequency for the 
plant, identify a half-carcass (selected by your random number method) 
from the predetermined point along the chain (cooler site) and then 
count back five (5) half-carcasses and select the next half-carcass 
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection. (See Sampling 
Frequency section to determine the rate of sampling.)

Swine Carcass Selection

    The carcasses eligible for sampling should be selected from those 
in the cooler 12 or more hours after slaughter. Every carcass should 
have an equal chance of being selected within the designated time frame 
(based on the sampling frequency for the plant). NOTE: If more than one 
shift is operating at the plant, the sample can be taken on any shift, 
provided the following requirements are met:
    Selection of TIME: Select the time, based on the appropriate 
sampling frequency, for collecting the sample.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the carcass. This site may be located at 
the transfer chain, grading chain, or a rail that contains carcasses 
that have been chilled 12 hours or more. If there are multiple sites of 
the same kind, select one at random.
    Selection of CARCASS: Based on the sampling frequency for the 
plant, identify a whole carcass from the predetermined point along the 
chain and then count back five (5) carcasses and select the next 
carcass for sampling. The reason for counting back five carcasses is to 
avoid any possible bias during selection. (See Sampling Frequency 
section to determine the rate of sampling.)
Aseptic Techniques/Sampling
    Extraneous organisms from the environment, hands, clothing, sample 
containers, sampling devices, etc., may lead to erroneous analytical 
results. More stringent requirements for microbiological analysis are 
necessary, therefore, use of aseptic sampling techniques and clean, 
sanitized equipment and supplies are of utmost importance.
    There should be an area designated for preparing sampling supplies, 
etc. A stainless steel, wheeled cart or table would be useful during 
sampling. A small tote or caddy could be moved to the location of 
sampling and could be used for carrying supplies, supporting sample 
bags when adding sterile solutions to sample bags, etc.
    Sterile gloves should be used for collecting samples. The only 
items which may contact the external surface of the glove are the 
exposed sample being collected and/or the sterile sample utensil 
(specimen sponge). Keep in mind that the outside surfaces of the sample 
container are not sterile. Do not handle the inside surface of the 
sterile sample containers. Do not touch anything else. The following 
procedure for putting on sterile gloves can be followed when collecting 
samples:
    (a) Peel open the package of sterile gloves from the top without 
contaminating (touching, breathing on, contacting, etc.) the exterior 
of the gloves.
    (b) Remove a glove by holding it from the wrist-side opening inner 
surface. Avoid any contact with the outer surface of the glove. Insert 
the washed and sanitized hand into the glove, taking care not to 
puncture the glove.
    (c) Taking care not to contaminate the exterior surface of the 
glove, repeat the above step for the hand you will use to physically 
handle the sample.
    (d) If at any time you are concerned that a glove may be
Preparation for Sample Collection
    Prior to collecting samples, review appropriate sampling steps, 
random selection procedures, and other information that will aid in 
sample collection.
    On the day prior to sample collection, after checking for 
cloudiness/turbidity, place the number of BPD containers that will be 
needed for the next day's sampling in the refrigerator/cooler. If 
samples are to be shipped to an off-site facility, pre-chill shipping 
container and refrigerator packs.
    On the day of sampling, gather all sample collection bags, sterile 
gloves, sanitizer, hand soap, sterile solutions for

[[Page 38931]]

sampling, and specific materials listed under the Materials section of 
the sample collection section for the type of carcass to be sampled. 
Ensure that all sampling supplies are on hand and readily available 
before beginning sample collection.
    Label the sample bags before starting the sampling procedure. Use 
permanent ink. If you are using paper labels, it is important that the 
label be applied to the bag at normal room temperature; it will not 
stick if applied in the cooler.
    Outer clothing (frocks, gloves, head gear, etc.) worn in other 
areas of the plant should be removed before entering the sampling area 
or preparing to collect samples. Replace outer clothing removed earlier 
with clean garments (i.e., laboratory coat) that have not been directly 
exposed to areas of the plant outside of the sampling area.
    Sanitize the sample work area surfaces by wiping with a clean 
disposable cloth or paper towel dipped in a freshly prepared 500 ppm 
(parts per million) sodium hypochlorite solution (0.05% sodium 
hypochlorite) or other approved sanitizer which provides an equivalent 
available chlorine concentration. The sample work area surfaces must be 
free of standing liquid before sample supplies and/or product 
containers are placed on them.
    Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include 
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands 
using disposable paper towels.
Specific Sample Collection Procedures
Cattle Sample Collection Procedure

Materials

1. Sterile specimen sponge in sterile Whirl-pack-type bag or 
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher bag
4. Template for 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use 
predetermined random selection procedures for selecting the half-
carcass to be sampled. Remember, samples will be collected from half-
carcasses in the cooler 12 hours or more after slaughter.
    A sampling sponge (which usually comes dehydrated and prepackaged 
in a sterile bag) will be used to sample all three sites on the carcass 
(flank, brisket, and rump--see Figure 2). It is important to swab the 
areas in the order of least to most contamination in order to avoid 
spreading any contamination.
    Therefore, swab the areas in the sequence indicated in this 
sampling protocol. Nondestructive surface sampling will be conducted as 
follows:
    1. Ensure that all bags have been pre-labeled and all supplies are 
on hand, including the sampling template. (An assistant may be helpful 
during the sampling process.)
    2. IF a reusable template is used, immerse the sampling template in 
an approved sanitizing solution for at least 1-2 minutes. Just prior to 
swabbing the first sample site on the carcass (step 13), retrieve the 
sampling template from the sanitizing solution. Shake excess solution 
from the utensil, then protect the portion of the template that will 
contact the carcass from contamination.
    3. Locate the flank, brisket, and rump sampling sites using 
illustrations and directions in Figure 2 (cattle carcass sampling 
locations).
    4. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the rump sample area (Figure 2) is within easy 
reach from the ladder.
    5. While holding the sponge bag at the top corner by the wire 
closure, tear off the clear, perforated strip at the top of the bag.
    6. Remove the cap from sterile BPD bottle, being careful not to 
touch the bottle opening.
    7. Carefully pour about half the contents of the sterile BPD bottle 
(approximately 10 ml) into the sponge bag to moisten the sponge.
    8. Close the top of the bag by pressing the wire closures together. 
Use hand pressure from the outside of the bag and carefully massage the 
sponge until it is FULLY HYDRATED (moistened).
    9. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag orienting one narrow end of the sponge 
up toward the opening of the bag. Do NOT open the bag or touch the 
sponge with your fingers. While holding the bag, gently squeeze any 
excess fluid from the sponge using hand pressure from the outside. The 
whole sponge should still be in the bag.
    10. Open the bag containing the sponge, being careful not to touch 
the inner surface of the bag with your fingers. The wire closure at the 
top of the bag should keep the bag open. Set bag aside.
    11. Put on a pair of sterile gloves.
    12. Carefully remove the moistened sponge from the bag with the 
thumb and fingers (index and middle) of your sampling hand.
    13. With the other hand, retrieve the template by the outer edge, 
taking care not to contaminate the inner edges of the sampling area of 
the template.
    14. Locate the flank sampling area (Figure 2). Place the template 
over this location.
    15. Hold the template in place with one gloved hand (Remember, only 
the sponge should touch the sampling area. Take care not to contaminate 
this area with your hands)
    16. With the other hand, wipe the sponge over the enclosed sampling 
area (10 cm x 10 cm) for a total of approximately 10 times in the 
vertical and 10 times in the horizontal directions. The pressure for 
swabbing would be as if you were removing dried blood from the carcass. 
However, the pressure should not be too hard as to crumble or destroy 
the sponge. (Note: The template may need to be ``rolled'' from side to 
side during swabbing since the surface of the carcass is not flat. This 
ensures that the 100 cm\2\ area is enclosed while swabbing.)
    17. Repeat steps 14-16 for the brisket area, using the SAME side or 
surface of the sponge used to swab the flank area.
    18. After swabbing the brisket area, transfer the template to the 
same hand holding the sponge. Do not contaminate the sponge or inner 
edges of the sampling area of the template.
    19. Climb the ladder or platform, holding onto the handrail with 
the hand used to hold the template. Once at a convenient and safe 
height for sampling the rump, transfer template back to ``climbing'' 
hand (hand used to hold onto the rail while climbing the ladder), 
taking care not to contaminate the inner edges of the template.
    20. Repeat steps 14-16 for the rump area, using the ``clean'' 
surface or side (the side that was NOT previously used to swab the 
flank/brisket areas) of the sponge.
    21. After swabbing the rump area, carefully place the sponge back 
in the sponge sample bag, taking care not to touch the sponge to the 
outside of the sample bag.
    22. While holding the handrail, climb down from the ladder.
    23. Add the additional BPD (about 15 ml) to the sample bag to bring 
the total volume to approximately 25 ml.
    24. Expel excess air from the bag containing the sponge and fold 
down the top edge of the bag 3 or 4 times to close. Secure the bag by 
folding the attached wire tie back against the bag.

[[Page 38932]]

Place closed sponge bag into second bag and close the second bag 
securely.
    25. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section)
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
    Swine surface sample collection procedure:

Materials

1. Sterile specimen sponge in sterile Whirl-Pak-type bag or 
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher-type bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use 
predetermined random selection procedures for selecting carcass to be 
sampled. Remember: samples will be collected from carcasses in the 
cooler 12 hours or more after slaughter. A sampling sponge (which 
usually comes dehydrated and prepackaged in a sterile bag) will be used 
to sample all three sites on the swine carcass (belly, ham, and jowl--
see Figure 3). It is important to swab the areas in the order of least 
to most contamination in order to avoid spreading any contamination. 
Therefore, swab the areas in the sequence indicated in this sampling 
protocol. Nondestructive surface sampling will be conducted as follows:
    1. Ensure that all supplies are on hand. (An assistant may be 
helpful during the sampling process.)
    2. If a reusable template is used, immerse the sampling template in 
a sanitizing solution for at least 1-2 minutes. Just prior to swabbing 
the first sample site on the swine carcass (step 12), retrieve the 
sampling template from the sanitizing solution. Shake excess solution 
from the utensil, then protect the portion of the template that will 
contact the carcass from contamination.
    3. Locate the belly, ham, and jowl sampling sites using 
illustrations and directions in Figure 3 (swine carcass sampling 
locations).
    4. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the ham sample area (Figure 3) is within easy reach 
from the ladder.
    5. Hold the sponge bag at the top corner by the wire closure, then 
tear off the clear perforated strip at the top of the bag. Open the 
bag.
    6. Remove the cap from sterile BPD bottle, being careful not to 
touch the bottle opening. Do not contaminate the lid.
    7. Carefully pour about half of the contents of the sterile BPD 
bottle (10 ml) into the sponge bag to moisten the sponge. Put the lid 
back on the BPD bottle.
    8. Close the top of the bag by pressing the wire closures together. 
Use hand pressure from the outside of the bag and carefully massage the 
sponge until it is FULLY HYDRATED (moistened).
    9. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag orienting one narrow end of the sponge 
up toward the opening of the bag. Do NOT open the bag or touch the 
sponge with your fingers. While holding the bag, gently squeeze any 
excess fluid from the sponge using hand pressure from outside. The 
whole sponge should still be inside the bag.
    10. Open the bag containing the sponge, being careful not to touch 
the inner surface of the bag with your fingers. The wire closure at the 
top of the bag should keep the bag open.
    11. Put on a pair of sterile gloves.
    12. Carefully remove the moistened sponge from the bag with the 
thumb and fingers (index and middle) of your sampling hand.
    13. With the other hand, retrieve the template by the outer edge, 
taking care not to contaminate the inner edges of the sampling area of 
the template.
    14. Locate the belly sampling area (Figure 2). Place the template 
over this location.
    15. Hold the template in place with one gloved hand. Remember, only 
the sponge should touch the sampling area. Take care not to contaminate 
this area with your hands.
    16. With the other hand, wipe the sponge over the enclosed sampling 
area (10 cm  x  10 cm) for a total of approximately 10 times in the 
vertical and 10 times in the horizontal directions. The pressure for 
swabbing would be as if you were removing dried blood from the carcass. 
However, the pressure should not be too hard as to crumble or destroy 
the sponge.

    Note: The template may need to be ``rolled'' from side to side 
during swabbing since the surface of the carcass is not flat. This 
ensures that the 100 cm2 area is enclosed while swabbing.

    17. After swabbing the belly area, transfer the template to the 
same hand that is holding the sponge. Do not contaminate the sponge or 
the inner edges of the sampling area of the template.
    18. Climb the ladder or platform, holding onto the handrail with 
the hand used to hold the sampling template in place. Once at a 
convenient and safe height for sampling the ham, transfer template back 
to the ``climbing'' hand (hand used to hold onto the rail while 
climbing the ladder), taking care not to contaminate the sponge or the 
inner edges of the template.
    19. Repeat steps 14-16 for the ham sampling area, using the SAME 
surface of the sponge used to swab the belly area.
    20. After swabbing the ham area, carefully place the template back 
to the same hand that is holding the sponge. Do not contaminate the 
sponge or the inner edges of the sampling area of the template.
    21. While holding the handrail, climb down from the ladder.
    22. Transfer the template back to the ``climbing'' hand (hand used 
to hold onto the rail while descending the ladder), taking care not to 
contaminate the sponge or the inner edges of the template.
    23. Repeat steps 14-16 for the jowl area, using the ``clean'' 
surface or side (the side that was not previously used to swab the 
belly/ham areas).
    24. After swabbing the jowl area, carefully place the sponge back 
into the sponge bag. Do not touch the surface of the sponge to the 
outside of the sponge bag.
    25. Add the additional BPD (about 15 ml) to the bag to bring the 
total volume to approximately 25 ml.
    26. Press wire closures of the sponge bag together, expel excess 
air, then fold down the top edge of the bag 3 or 4 times. Secure the 
bag by folding the attached wire tie back against the bag. Place the 
closed sponge bag into the second bag and close the second bag 
securely.
    27. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section).
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
Sample Shipment
    Samples analyzed on-site must be analyzed as soon after collection 
as possible. If no on-site facilities are available, the samples must 
be shipped the same calendar day as collected, to

[[Page 38933]]

an outside laboratory. The samples must be analyzed no later than the 
day after collection.
    1. Prechill shipping container by placing the open shipping 
container in the refrigerator at least the day before sampling.
    2. Place the appropriately-labeled, double-bagged sample(s) in the 
prechilled shipping container in an upright position to prevent 
spillage. Newspaper may be used for cushioning the sample and holding 
it in the upright position. If more than one sample is collected during 
the day, take steps to ensure that samples are maintained at 
refrigeration temperature. Refrigeration temperatures help limit 
multiplication of any microorganisms present which ensures the most 
accurate results.
    3. Place a corrugated cardboard pad on top of samples. This 
corrugated cardboard pad prevents direct contact of frozen gel packs 
with the samples. Next place the frozen gel pack(s) on top of the 
corrugated pad. Use sufficient frozen coolant to keep the sample 
refrigerated during shipment to the designated laboratory. Insert foam 
plug and press it down to minimize shipper head space.
    4. Ship samples (via overnight delivery or courier) to the assigned 
laboratory.
Analytical Methods
    Samples must be analyzed using one of the E. coli (Biotype I) 
quantitation methods found in the Official Methods of Analysis of the 
Association of Official Analytical Chemists (AOAC), International, 16th 
edition, or by any method which is validated by a scientific body in 
collaborative trials against the three tube Most Probable Number (MPN) 
method and agreeing with the 95% upper and lower confidence limits of 
the appropriate MPN index.
Suggested Quantitation Schemes
    If a generic one ml plating technique is used for E. coli 
quantitation for cattle or swine carcass sponging sample analysis, the 
plate count would be divided by 12 to equal the count per cm\2\. To 
cover the marginal and unacceptable range for E. coli levels (described 
in later section), the undiluted sample extract, a 1:10, a 1:100, a 
1:1,000 and a 1:10,000 dilution should be plated, preferably in 
duplicate. Higher or lower dilutions may need to be plated based on the 
specific product.
    If a hydrophobic grid membrane filtration method were used, the 
only difference would be filtration of one ml of the undiluted sample 
extract, 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
    Additional dilutions of the original extract may need to be used if 
a three tube MPN protocol is used. The three highest dilutions that 
were positive for E. coli are used to calculate the MPN. MPN values 
from the appropriate MPN Table represent the count per ml of original 
extract and therefore must be divided by 12 to obtain the count per 
cm\2\ of carcass surface area.
Record Keeping
    Each test result must by recorded in terms of colony forming units 
per square centimeter (cfu/cm\2\). A process control table or chart can 
be used to record the results and facilitate evaluation. Results should 
be recorded in the order of sample collection and include information 
useful for determining appropriate corrective actions when problems 
occur. The information needed for each sample includes date and time of 
sample collection, and, if more than one slaughter line exists, the 
slaughter line from which the sample was collected. These records are 
to be maintained at the establishment for twelve months and must be 
made available to Inspection Program employees on request. Inspection 
personnel review results over time, to verify effective and consistent 
process control.
    For E. coli testing to be the most useful for verifying process 
control, timeliness is important and the record should be updated with 
the receipt of each new result. Detailed records should also be kept of 
any corrective actions taken if process control deviations are detected 
through microbiological testing.

Applying Performance Criteria to Test Results

Categorizing Test Results
    E. coli test levels have been separated into 3 categories for the 
purpose of process control verification: acceptable, marginal, and 
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper 
limits for the acceptable and marginal ranges were denoted by m and M.) 
These categories are described by slaughter species in Table 3.

             Table 3.--Values for Marginal and Unacceptable Results for E. Coli Performance Criteria            
----------------------------------------------------------------------------------------------------------------
           Slaughter class                 Acceptable range          Marginal range         Unacceptable range  
----------------------------------------------------------------------------------------------------------------
Cattle...............................  Negative*..............  Positive but not above   Above 100 cfu/cm\2\.   
                                                                 100 cfu/cm\2\.                                 
Swine................................  10 cfu/cm\2\...........  Above 10 cfu/cm\2\ but   Above 10,000 cfu/cm\2\.
                                                                 not above 10,000 cfu/                          
                                                                 cm\2\.                                         
----------------------------------------------------------------------------------------------------------------
* It should be noted that negative here is defined by the sensitivity of the sampling and test method used in   
  the Baseline survey (5 cfu/cm\2\ carcass surface area).                                                       

    To illustrate the use of Table 3, consider a steer/heifer slaughter 
establishment. E. coli test results for this establishment will be 
acceptable if negative, marginal if positive but not above 100 cfu/
cm\2\, and unacceptable if above 100 cfu/cm\2\.
Verification Criteria
    The verification criteria are applied to test results in the order 
that samples are collected. The criteria consist of limits on 
occurrences of marginal and unacceptable results.
    As each new test result is obtained, the verification criteria are 
applied anew to evaluate the status of process control with respect to 
fecal contamination.
    1. An unacceptable result should trigger immediate action to review 
process controls, discover the cause if possible, and prevent 
recurrence.
    2. A total of more than three marginal or unacceptable results in 
the last 13 consecutive results also signals a need to review process 
controls.
    This way of looking at the number of marginal and unacceptable 
results is described as a ``moving window'' approach in the regulation. 
With this approach, results are accumulated until 13 have been accrued. 
After this, only the most recent 13 results--those in the ``moving 
window''--are considered.
    An example of a record of results for Steer/Heifer testing is shown 
(in table form) below for an establishment performing two tests per 
day.

[[Page 38934]]



----------------------------------------------------------------------------------------------------------------
                                                                                     Number                     
                       Time      Test result         Result           Result       marginal or                  
 Test #     Date    collected    (cfu/cm\2\)     unacceptable?      marginal?     unacceptable     Pass/fail?   
                                                                                   in last 13                   
----------------------------------------------------------------------------------------------------------------
1......     10-07      08:50   10.............  No.............  Yes............           1    Pass            
2......  .........     14:00   Negative.......  No.............  No.............           1    Pass            
3......     10-08      07:10   50.............  No.............  Yes............           2    Pass            
4......  .........     13:00   Negative.......  No.............  No.............           2    Pass            
5......     10-09      10:00   Negative.......  No.............  No.............           2    Pass            
6......  .........     12:20   Negative.......  No.............  No.............           2    Pass            
7......     10-10      09:20   80.............  No.............  Yes............           3    Pass            
8......  .........     13:30   Negative.......  No.............  No.............           3    Pass            
9......     10-11      10:50   Negative.......  No.............  No.............           3    Pass            
10.....  .........     14:50   Negative.......  No.............  No.............           3    Pass            
11.....     10-14      08:40   50.............  No.............  Yes............           4    Fail            
12.....  .........     12:00   Nonegative.....  No.............  No.............           4    Fail            
13.....     10-15      09:30   Negative.......  No.............  No.............           4    Fail            
14.....  .........     15:20   Negative.......  No.............  No.............           3    Pass            
15.....     10-16      07:30   Negative.......  No.............  No.............           3    Pass            
16.....  .........     11:40   Negative.......  No.............  No.............           2    Pass            
17.....     10-17      10:20   120............  Yes............  No.............           3    Fail            
----------------------------------------------------------------------------------------------------------------

    The following observations can be made on this example:
    1. As of 10-14 at 08:40, there are four marginal or unacceptable 
results in the last 11 results, which exceeds the limit of 3 in 13 
consecutive tests.
    2. The limit of 3 in 13 also is exceeded for the next two tests, 
but since no new marginal or unacceptable result has occurred, these 
failures should not be treated as evidence of a new problem. The log or 
documentation of corrective action taken for the first failure should 
be adequate to verify that the deviation or problem was addressed.
    3. On 10-15 at 15:20 the number of marginal or unacceptable results 
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped and replaced by an acceptable result as the 13-
test window moves ahead 1 test.
    4. The result for 10-17 at 10:20 exceeds 100 and is unacceptable.
    Figure 4 shows the same results as the above example but the 
results are displayed in chart form. The numbers along the horizontal 
axis of the graph (x-axis), refers to the test number in the chart 
above. The information for each test result, such as the time and date 
the sample was collected could also be recorded on the chart.

BILLING CODE 3410-DM-P

[[Page 38935]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.021



[[Page 38936]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.022



[[Page 38937]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.023



[[Page 38938]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.024



BILLING CODE 3410-DM-C

[[Page 38939]]

Appendix G--Guidelines for Escherichia coli Testing for Process Control 
Verification in Poultry Slaughter Establishments

Introduction

    Under the Pathogen Reduction/HACCP Regulation, all poultry 
slaughter establishments will be required to test carcasses for generic 
E. coli as a tool to verify process control. This document outlines the 
sampling and microbial testing that should be followed to meet this 
requirement. It also gives guidance to interpreting your results. This 
document is a supplement to the Regulation, but not a substitute for 
it. Further in-depth details of the program may be found in the 
Regulation. Please provide these guidelines to your company 
microbiologist or testing laboratory in order to help you meet the 
regulatory requirements for generic E. coli testing.

Guidelines for Sample Collectors/Microbiologists

Background
    This sampling protocol has been prepared to support the Pathogen 
Reduction/HACCP Regulation. Carcass sampling for broiler and turkey 
carcasses remain the nondestructive whole bird rinse which was used in 
the FSIS Nationwide Microbiological Baseline Data Collection Programs.
    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 across the 
nation. It is imperative that all like establishments adhere to the 
same sampling and analysis requirements detailed here, without 
deviation. These sampling and analytical procedures may be directly 
written into your establishment's individual HACCP plan.
    Poultry carcasses must be sampled after the chill tank at the end 
of the drip line or last readily accessible point prior to packing/cut-
up. This sample collection location is the same as that in the FSIS 
baseline studies, making samples taken here comparable to the 
nationwide baseline performance criteria.
Pre-sampling Preparation
    Sample collection will be carried out by the individual designated 
in the establishment's written protocol for microbiological sampling. 
The protocol should include a check list of tasks to be performed prior 
to sample collection, materials needed for sample collection, random 
selection procedures, where the samples will be analyzed (on-site 
versus off-site), and other information that will aid the sample 
collector. As stated previously, this guideline can be a part of the 
plant's sample collection guidelines, but plant specific details and 
procedures will need to be included. Sampling supplies, such as sterile 
gloves, sterile sampling solutions, hand soap, sanitizing solution, 
etc., need to be assembled prior to beginning sample collection.
    Sterile sampling solutions, Butterfield's phosphate diluent (BPD), 
can be stored at room temperature. However, at least on the day prior 
to sample collection, check solutions for cloudiness (DO NOT use 
solutions that are cloudy, turbid or contain particulate matter) and 
place the number of containers of sampling solution (BPD) that will be 
needed for the next day's sampling in the refrigerator.
    To obtain the most accurate results, samples should be analyzed as 
soon after collection as possible. However, if samples must be 
transported to an off-site laboratory, the samples need to be 
maintained at refrigeration temperatures until transport, then shipped 
refrigerated via an overnight delivery service to the laboratory 
performing the analysis. Samples analyzed off-site must be picked up by 
the overnight courier the SAME calendar day the sample is collected. 
The sample must arrive at the laboratory no later than the day after 
the sample is collected. Samples shipped to an outside laboratory must 
be analyzed no later than the day after collection. The following 
section gives information on shipping containers and transporting 
samples to off-site facilities.

Shipping Containers and Coolant Packs

    It is important that samples fit easily into the shipping 
containers so that the sample bags do not break.
    Correct use of the refrigerant gel-ice packs and proper packing of 
the shipping container are necessary so that samples arrive at the 
laboratory at an acceptable temperature. Frozen samples or samples 
which are too warm are not considered valid and must not be analyzed. 
Some bacteria may be damaged by temperatures that are too cold, while 
temperatures that are too warm can allow bacteria to reproduce. 
Maintaining samples at improper temperatures may cause inaccurate 
sample results.
    The sample should be kept refrigerated, NOT FROZEN, in the shipping 
container prior to pickup by the courier service. The shipping 
container, itself, should not be used as a refrigerator. However, 
multiple samples (if needed) for that day may be stored in the open 
shipping container in the cooler or refrigerator.
Sampling Frequency
    Sampling frequency for E. coli testing is determined by production 
volume. The required minimum testing frequencies for all but very low 
production volume establishments are shown in Table 1 by slaughter 
species.

                 Table 1.--E. coli Testing Frequencies a                
------------------------------------------------------------------------
                                                                        
------------------------------------------------------------------------
Chickens............................  1 test per 22,000                 
                                      carcasses.                        
Turkeys.............................  1 test per 3,000                  
                                      carcasses.                        
------------------------------------------------------------------------
a Note: These testing frequencies do not apply to very low volume       
  establishments. See Table 2.                                          

Very Low Volume Establishments

    Some establishments may be classified as very low volume 
establishments based on their annual production volume. The maximum 
yearly slaughter volumes for very low volume establishments are 
described in Table 2.

 Table 2.--Maximum Yearly Poultry Slaughter Volumes for Very Low Volume 
                             Establishments                             
------------------------------------------------------------------------
                                             Criteria (yearly slaughter 
             Slaughter species                         volume)          
------------------------------------------------------------------------
Chickens..................................  Not more than 440,000 birds.
Turkeys...................................  Not more than 60,000 birds. 
Chickens and turkeys......................  Not more than 440,000 total,
                                             with not more than 60,000  
                                             turkeys.                   
------------------------------------------------------------------------

    Establishments with very low volumes are to sample the predominant 
species once per week, initially, until at least 13 test results have 
been obtained.
    Once the initial criteria have been met for very low volume 
establishments (see APPLYING PERFORMANCE CRITERIA TO TEST RESULTS), the 
establishment will repeat the same sampling regime once per year, in 
the 3 month period of June through August, or whenever a change is made 
in the slaughter process or personnel.
Random Selection of Carcasses
    Samples are to be taken randomly at the required frequency (See 
section on Sampling Frequency). For example, given the frequency of 
testing for turkeys is 1 (one) test per every 3,000 turkeys 
slaughtered, then if a plant slaughters 1,500 turkeys an hour, 1 (one) 
sample will be taken every 2 hours.
    Different methods of selecting the specific carcass for sampling 
could be used, but all require the use of random

[[Page 38940]]

numbers. Methods could include: using random number tables, using 
calculator- or computer-generated random numbers, drawing cards, etc. 
When selecting the random numbers, use the method(s) currently in use 
at the establishment for other sampling programs, if other programs are 
currently underway.
    The carcass for sampling must be selected at random from all 
eligible carcasses. If multiple lines exist, randomly select the line 
for sample collection for that interval. Repeat the random selection 
process for the next sampling interval. Each line should have an equal 
chance of being selected at each sampling interval.

Poultry Carcass Selection

    The poultry carcasses will be selected at random after chilling, at 
the end of the drip line or last readily accessible point prior to 
packing/cut-up. A WHOLE carcass is required, that is, one that has not 
been trimmed.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:
    Selection of TIME: Select the time, based on the appropriate 
sampling frequency, for collecting the sample.
    Selection of CHILLER: If more than one chiller system is in 
operation at the time of sample collection, the chill tank from 
which the sample is selected must be randomly selected.
    Selection of POULTRY CARCASS: Based on the frequency of sampling 
for your establishment, identify a carcass (selected by your random 
number method) from the predetermined point, and then count back 
five (5) carcasses and select the next carcass for sampling. 
Exception: If the fifth carcass is not a WHOLE (untrimmed) bird, 
count back an additional five carcasses for sample selection. Each 
carcass must have an equal chance of being selected. The reason for 
counting back five carcasses is to avoid any possible bias during 
selection.
Aseptic Techniques/Sampling
    Extraneous organisms from the environment, hands, clothing, sample 
containers, sampling devices, etc., may lead to erroneous analytical 
results. Stringent requirements for microbiological analysis are 
necessary, therefore, use of aseptic sampling techniques and clean 
sanitized equipment and supplies are of utmost importance.
    There should be an area designated for preparing sampling supplies, 
etc. A stainless steel, wheeled cart or table would be useful during 
sampling. A small tote or caddy could be easily moved to the location 
of sampling and could be used for carrying supplies, supporting sample 
bags when adding sterile solutions to sample bags, etc.
    Sterile gloves should be used for collecting samples. The only item 
which may contact the external surface of the glove is the exposed 
sample being collected. Keep in mind that the outside surfaces of the 
sample container are not sterile. Do not handle the inside surface of 
the sterile sample containers. Do not touch anything else. The 
following procedure for putting on sterile gloves can be followed when 
collecting samples:
    (a) Peel open the package of sterile gloves from the top without 
contaminating (touching, breathing on, contacting, etc.) the exterior 
of the gloves.
    (b) Remove a glove by holding it from the wrist-side opening inner 
surface. Avoid any contact with the outer surface of the glove. Insert 
the washed and sanitized hand into the glove, taking care not to 
puncture the glove.
    (c) Next, taking care not to contaminate the outer surface of the 
glove, repeat the step above for the hand you will use to physically 
handle the sample.
    (d) If at any time you are concerned that a glove may be 
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
    Prior to collecting samples, review appropriate sampling steps, 
random selection procedures, and other information that will aid in 
sample collection.
    On the day prior to sample collection, after checking for 
cloudiness/turbidity, place the number of Butterfield's phosphate 
diluent (BPD) containers that will be needed for the next day's 
sampling in the refrigerator/cooler. If samples will be shipped to an 
off-site facility, pre-chill shipping container and refrigerator packs 
(follow manufacturer's directions for gel-packs).
    On the day of sampling, gather all sample collection bags, sterile 
gloves, sanitizer, hand soap, sterile solutions for sampling (BPD), and 
specific materials listed under the Materials section of the sample 
collection section for the type of carcass to be sampled. Ensure that 
all sampling supplies are on hand and readily available before 
beginning sample collection.
    Label the sample bags before starting the sampling procedure. Use 
permanent ink. If you are using paper labels, it is important that the 
label be applied to the bag at normal room temperature; it will not 
stick if applied in the cooler.
    Outer clothing (frocks, gloves, head gear, etc.) worn in other 
areas of the plant should be removed before entering the sampling area 
or preparing to collect samples. Replace outer clothing removed earlier 
with clean garments (i.e., laboratory coat) that have not been directly 
exposed to areas of the plant outside of the sampling area.
    Sanitize the sample work area surfaces by wiping with a clean 
disposable cloth or paper towel dipped in a freshly prepared 500 ppm 
sodium hypochlorite solution (0.05% sodium hypochlorite) or other 
approved sanitizer which provides an equivalent available chlorine 
concentration. The sample work area surfaces must be free of standing 
liquid before sample supplies and/or product containers are placed on 
them.
    Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include 
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands 
using disposable paper towels.
Specific Sample Collection Procedures
Chicken Carcass Rinse Sampling Procedure

Materials

    1. 2 Sterile 3500 milliliter (ml) stomacher-type or ziplock-type 
bags or equivalent. (The bag must be sterile and should be large enough 
to hold the carcass while rinsing.)
    2. 400 ml sterile, Butterfield's phosphate diluent (BPD).
    3. Plastic tie wraps or equivalent (if needed to secure the bag).
    4. Sterile gloves.
    5. Optional--(See alternate sampling--step 10)--Sterile leak-proof 
container.

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use the 
predetermined random selection procedure to select the carcass to 
sample. The randomly selected bird will be collected after the chiller, 
at the end of the drip line as follows:
    1. Ensure all sampling supplies are present and have been properly 
labeled. An assistant may be helpful during sampling.
    2. Open a large stomacher-type bag without touching the sterile 
interior of the bag. (Rubbing the top edges of the bag between the 
thumb and forefinger will cause the opening to gap for easy opening.)
    3. Put on sterile gloves.
    4. With one hand, push up through the bottom of the sampling bag to 
form

[[Page 38941]]

a ``glove'' over one hand with which to grab the bird, while using your 
other hand to pull the bag back over the hand that will grab the bird. 
This should be done aseptically without touching the exposed interior 
of the bag.
    5. Using the hand with the bag reversed over it, pick up the bird 
by the legs (hocks) through the stomacher bag. (The bag functions as a 
`glove' for grabbing the bird's legs.) Take care not to contaminate the 
exposed interior of the bag. Allow any excess fluid to drain before 
reversing the bag back over the bird. (Alternately, have an assistant 
hold open the bag. Using your gloved hand, pick up the bird by the 
legs, allow any fluid to drain, and place the bird in the sampling 
bag.)
    6. Rest the bottom of the bag on a flat surface. While still 
holding the top of the bag slightly open, add the sterile BPD (400 ml) 
to the bag containing the carcass, pouring the solution over the 
carcass.

(Alternately, with the aid of an assistant holding the bag open, add 
the sterile BPD (400 ml) to the bag containing the carcass, pouring the 
solution over the carcass.)
    7. Expel most of the air from the bag, then close the top of the 
bag. While securely holding the bag, rinse the bird inside and out 
using a rocking motion for 30 shakes (approximately one minute). This 
is done by holding the bird through the bottom of the bag with one hand 
and the closed top of the bag with the other hand. Hold the bird 
securely and rock it in an arcing motion, alternating the weight of the 
bird from one hand to the other (motion like drawing an invisible 
rainbow or arch), assuring that all surfaces (interior and exterior of 
the carcass) are rinsed.
    8. Rest the bag with the bird on a flat surface and, while still 
supporting the bird, open the bag.
    9. With a gloved hand, remove the carcass from the bag. Since the 
carcass was rinsed with a sterile solution, it can be returned to the 
chill tank. Be sure not to touch the interior of the bag with your 
gloved hand.
    10. Secure the top of the bag so that the rinse fluid will not 
spill out or become contaminated.

(Alternately, at least 30 milliliters of rinse fluid can be poured into 
a sterile leak-proof container to be sent to the lab for analysis.)
    11. Place the sample bag (or leak-proof container) into another bag 
and secure the opening of the outer bag.
    12. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis.
     (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Turkey Carcass Rinse Sampling Procedure

Materials

    1. 2 Sterile 3500 ml stomacher-type or ziplock-type bags or 
equivalent. (The bag must be sterile and should be large enough to hold 
the carcass while rinsing, the bags FSIS will be using for the 
Salmonella sampling program measure approximately 18''  x  24''. Large 
turkeys should be placed in a plain, clear polypropylene autoclave bag 
, about 24''  x  30'' to 36'').
    2. 600 ml sterile, Butterfield's phosphate diluent (BPD)
    3. Plastic tie wraps or thick rubber bands or equivalent, if needed 
to secure sample bag
    4. Sterile gloves
    5. Optional--sterile, leak-proof container (see step 12 Alternate 
procedure)

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use a 
predetermined random selection procedure to select the carcass to be 
sampled. The randomly selected bird will be collected after the 
chiller, at the end of the drip line as follows:
    1. Ensure that all supplies are on hand and readily available. An 
assistant will be needed to hold the bag for collecting the bird.
    2. Have an assistant open the large sterile stomacher-type bag 
(designated for rinsing the carcass) and be ready to receive the turkey 
carcass. (Rubbing the top edges of the bag between the thumb and index 
finger will cause the opening to gap open).

(Alternately: If no assistant is available, place the closed large 
sampling bag into a bucket or pail (e.g., use the bag to ``line'' a 
bucket like a trash-can liner), then open the bag. The bucket will be 
used as a holder or stand to support the bag. Do not contaminate the 
inner surfaces of the sampling bag.)
    3. Put on sterile gloves.
    4. Remove the selected turkey from the drip line by grasping it by 
the legs and allowing any fluid to drain from the cavity.
    5. Place the turkey carcass, vent side up, into a sterile sampling 
bag. Only the carcass should come in contact with the inside of the 
bag.
    6. Manipulate the loose neck skin on the carcass through the bag 
and position it over the neck bone area to act as a cushion and prevent 
puncturing of the bag. The assistant will need to support the carcass 
with one hand on the bottom of the bag.
    7. While still supporting the bottom of the bag, have the assistant 
open the bag with the other hand. Alternately, rest the bottom of the 
bag on a pre-sanitized surface (i.e. a table), and while still 
supporting the carcass in the bag, open the bag with the other hand.
    8. Add the sterile BPD (600 ml) to the bag containing the carcass, 
pouring the diluent over the carcass.
    9. Take the bag from the assistant and expel excess air from the 
bag and close the top. While securely holding the bag, rinse the bird 
inside and out using a rocking motion for 30 shakes (approximately one 
minute). This is done by holding the carcass through the bag with one 
hand and the closed top of the bag with the other hand. Holding the 
bird securely with both hands, rock in an arcing motion alternating the 
weight of the bird from one hand to the other (motion like drawing an 
invisible rainbow or arch), assuring that all surfaces (interior and 
exterior of the carcass) are rinsed.
    10. Hand the bag back to the assistant.
    11. With a gloved hand, remove the carcass from the bag letting 
excess fluid drain back into the bag. Since the carcass was rinsed with 
a sterile solution, it can be returned to the chill tank. Be sure not 
to touch the interior of the bag with your gloved hand.
    12. Expel excess air, taking care not to expel any rinse fluid. 
Secure the top of the bag so that the rinse fluid will not spill out or 
become contaminated.

(Alternately, at least 30 milliliters of rinse fluid can be poured into 
a sterile, leak-proof container and sent to the lab for analysis.)
    13. Place the sample bag (or container) into another bag and secure 
the opening of the outer bag.
    14. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis. (See 
Analytical Methods section.)
     (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
    Samples analyzed on-site must be analyzed as soon after collection 
as possible. If no on-site facilities are available, the samples must 
be shipped the same calendar day as collected, to an outside 
laboratory. The samples must be analyzed no later than the day after 
collection.

[[Page 38942]]

    1. Prechill shipping container by placing the open shipping 
container in the refrigerator at least the day before sampling.
    2. Place the appropriately-labeled, double-bagged sample in the 
prechilled shipping container in an upright position to prevent 
spillage. Newspaper may be used for cushioning the sample and holding 
it in the upright position. Ensure that samples are maintained at 
refrigeration temperature. Refrigeration temperatures limit 
multiplication of any microorganisms present.
    3. Place a corrugated cardboard pad on top of samples. The 
corrugated pad prevents direct contact of frozen gel packs with the 
samples. Next, place the frozen gel pack(s) on top of the corrugated 
pad. Use sufficient frozen coolant to keep the sample refrigerated 
during shipment to the designated laboratory. Insert foam plug and 
press it down to minimize shipper head space.
    4. Ship samples (via overnight delivery or courier) to the assigned 
laboratory.
Analytical Methods
    Samples must be analyzed using one of the E. coli (Biotype I) 
quantitation methods found in the Official Methods of Analysis of the 
Association of Official Analytical Chemists (AOAC), International, 16th 
edition, or by any method which is validated by a scientific body in 
collaborative trials against the three tube Most Probable Number (MPN) 
method and agreeing with the 95% upper and lower confidence limits of 
the appropriate MPN index.
Suggested Quantitation Schemes
    For poultry rinse fluid samples, if a generic one ml plating 
technique is used for E. coli quantitation, the plate count would not 
have to be divided to get the count per ml of rinse fluid. To cover the 
marginal and unacceptable range for E. coli levels (described in later 
section), the undiluted extract (optional), a 1:10, a 1:100, a 1:1,000 
and a 1:10,000 dilution should be plated, preferably in duplicate. 
Higher or lower dilutions may need to be plated based on the specific 
product.
    If a hydrophobic grid membrane filtration method were used, the 
only difference would be filtration of one ml of the undiluted extract 
(optional), 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
    Additional dilutions of the original extract may need to be used if 
a three tube MPN protocol is used. The three highest dilutions that 
were positive for E. coli are used to calculate the MPN.
Record Keeping
    Results of each test must by recorded, in terms of colony forming 
units per milliliter rinse fluid (cfu/ml) for chicken and turkeys. A 
process control table or chart can be used to record the results and 
facilitate evaluation. Results should be recorded in the order of 
sample collection and include information useful for determining 
appropriate corrective actions when problems occur. The information 
needed for each sample includes date and time of sample collection, 
and, if more than one slaughter line exists, the slaughter line from 
which the sample was collected. These records are to be maintained at 
the establishment for twelve months and must be made available to 
Inspection Program employees on request. Inspection personnel review 
results over time, to verify effective and consistent process control.
    For E. coli testing to be the most useful for verifying process 
control, timeliness is important and the record should be updated with 
the receipt of each new result. Detailed records should also be kept of 
any corrective actions taken if process control deviations are detected 
through microbiological testing.

Applying Performance Criteria to Test Results

Categorizing Test Results
    E. coli test levels have been separated into 3 categories for the 
purpose of process control verification: acceptable, marginal, and 
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper 
limits for the acceptable and marginal ranges were denoted by m and M.) 
These categories are described by slaughter species in Table 3.

                                 Table 3.--Values for Marginal and Unacceptable Results for E. coli Performance Criteria                                
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Slaughter class                           Acceptable range                       Marginal range                   Unacceptable range        
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chicken...............................  100 cfu/ml or less.........................  Over 100 cfu/ml but not over    Above 1,000 cfu/ml.                
                                                                                      1,000 cfu/ml.                                                     
Turkey................................  NA *.......................................  NA *..........................  NA *.                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The FSIS Baseline study has not been completed for this slaughter class. Levels will be set upon completion of this baseline.                         

    To illustrate the use of Table 3, consider a chicken slaughter 
establishment. E. coli test results for this establishment will be 
acceptable if not above 100 cfu/ml, marginal if above 100 cfu/ml but 
not above 1,000 cfu/ml, and unacceptable if above 1,000 cfu/ml.
Verification Criteria
    The verification criteria are applied to test results in the order 
that samples are collected. The criteria consist of limits on 
occurrences of marginal and unacceptable results.
    As each new test result is obtained, the verification criteria are 
applied anew to evaluate the status of process control with respect to 
fecal contamination.
    1. An unacceptable result should trigger immediate action to review 
process controls, discover the cause if possible, and prevent 
recurrence.
    2. A total of more than three marginal or unacceptable results in 
the last 13 consecutive results also signals a need to review process 
controls.
    This way of looking at the number of marginal and unacceptable 
results is described as a ``moving window'' approach in the regulation. 
With this approach, results are accumulated until 13 have been accrued. 
After this, only the most recent 13 results--those in the ``moving 
window''--are considered.
    An example of a record of results for Chicken testing is shown (in 
table form) below for an establishment performing two tests per day.

[[Page 38943]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                          Number                        
                                                      Time     Test result                                              marginal or                     
              Test No.                   Date      collected     (cfu/ml)   Result unacceptable?    Result marginal?   unacceptable       Pass/Fail?    
                                                                                                                        in last 13                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..................................        10-07        08:50          120  No..................  Yes................             1  Pass.              
2..................................  ...........        14:00           10  No..................  No.................             1  Pass.              
3..................................        10-08        07:10          150  No..................  Yes................             2  Pass.              
4..................................  ...........        13:00           50  No..................  No.................             2  Pass.              
5..................................        10-09        10:00        (\1\)  No..................  No.................             2  Pass.              
6..................................  ...........        12:20           10  No..................  No.................             2  Pass.              
7..................................        10-10        09:20          800  No..................  Yes................             3  Pass.              
8..................................  ...........        13:30           10  No..................  No.................             3  Pass.              
9..................................        10-11        10:50           10  No..................  No.................             3  Pass.              
10.................................  ...........        14:50           10  No..................  No.................             3  Pass.              
11.................................        10-14        08:40          500  No..................  Yes................             4  Fail.              
12.................................  ...........        12:00           30  No..................  No.................             4  Fail.              
13.................................        10-15        09:30           10  No..................  No.................             4  Fail.              
14.................................  ...........        15:20           10  No..................  No.................             3  Pass.              
15.................................        10-16        07:30           10  No..................  No.................             3  Pass.              
16.................................  ...........        11:40           10  No..................  No.................             3  Pass.              
17.................................        10-17        10:20        1,200  Yes.................  No.................             3  Fail.              
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Negative.                                                                                                                                           

    The following observations can be made on this example:
    1. As of 10-14 at 08:40, there are four marginal or unacceptable 
results in the last 11 results, which exceeds the limit of 3 in 13 
consecutive tests.
    2. The limit of 3 in 13 also is exceeded for the next two tests, 
but since no new marginal or unacceptable result has occurred, these 
failures should not be treated as evidence of a new problem. The log or 
documentation of corrective action taken for the first failure should 
be adequate to verify that the deviation or problem, if any, was 
addressed.
    3. On 10-15 at 15:20 the number of marginal or unacceptable results 
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped replaced by an acceptable result as the 13-test 
window moves ahead 1 test.
    4. The result for 10-17 at 10:20 exceeds 1,000 and is unacceptable.
    The Figure 1 shows the same results as above displayed in chart 
form. The numbers along the horizontal axis of the graph (x-axis) refer 
to the test number in the chart above. The information for each test 
result, such as the time and date the sample was collected could also 
be recorded on the chart.

BILLING CODE 3410-DM-P

[[Page 38944]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.025



BILLING CODE 3410-DM-C

[[Page 38945]]

    Note: The following Supplement will not appear in the Code of 
Federal Regulations.

    Supplement--Final Regulatory Impact Assessment for Docket No. 93-
016F, ``Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems.''

Table of Contents

I. Introduction
    A. Purpose
    B. Methodology
    C. Summary Comparison of Costs and Benefits--Proposal to Final
II. Regulatory Alternatives
    A. Market Failure
    B. General Regulatory Approaches
    C. Need For Improved Process Control
    D. Regulatory Alternatives for Process Control
    1. Mandatory HACCP
    2. Alternatives to Mandatory HACCP
    E. Comments on Analysis of Regulatory Alternatives
III. Summary of Impacts
    A. Introduction
    B. Net Benefit Analysis
    C. Impact on ``Smaller'' Businesses
    D. Effect on Retail Price
    E. Impact on International Trade
    F. Impact on Agency Costs
    G. Impact on State Programs
    H. Consumer Welfare Analysis
IV. Analysis of Public Health Benefits
    A. Introduction
    B. FSIS Risk Assessment
    C. Risk Assessment Framework
    D. FSIS Data Initiatives
    E. ARS Food Safety Research Program
    F. Analysis of Comments on Public Health Benefits
    1. Incidence of Foodborne Illness
    2. Cost of Foodborne Illness
    3. Percentage of Foodborne Illness and Cost of Foodborne Illness 
Attributable to Meat and Poultry
    4. Pathogens Addressed by the Rule
    5. Effectiveness of the Rule in Reducing Pathogens
    6. Estimated Reduction in Cost of Foodborne Illness
    G. Summary
V. Cost Analysis
    A. Introduction
    B. Methodology for Cost Analysis
    C. Regulatory Flexibility
    D. Final Cost Estimates
    1. Sanitation Standard Operating Procedures
    2. Costs of Meeting Pathogen Reduction and Microbial Sampling
    3. HACCP Programs--Plan Development and Annual Reassessment 
Costs
    4. HACCP Programs--Recordkeeping Costs
    5. HACCP Programs--Training Costs
    6. HACCP Programs--Impact on Total Quality Control/Overtime 
Issues
    E. Summary of Costs for Low Volume Producers

Appendix A to Final Regulatory Impact Assessment

I. Introduction

A. Purpose

    In docket No. 93-016F, the Food Safety and Inspection Service 
(FSIS) is promulgating new regulations that require an estimated 9,079 
inspected meat and poultry establishments to adopt a Hazard Analysis 
and Critical Control Points (HACCP) processing control system covering 
all production operations within 3\1/2\ years of final rule 
publication. The regulation also requires that all 9,079 establishments 
adopt and implement standard operating procedures (SOP's) for 
sanitation and establishes, for the first time, food safety performance 
standards for microorganisms on raw meat and poultry products. This 
final rule establishes pathogen reduction performance standards for 
Salmonella that are established using the current pathogen prevalence 
as determined by the national baseline studies. These standards are not 
directed at judging whether specific lots of a product are adulterated 
under the law. Rather, compliance with the standards will be determined 
by a statistical evaluation of the prevalence of bacteria in each 
establishment's products. FSIS will implement sampling programs to 
determine compliance with the Salmonella standard. The rule does not 
require inspected establishments to test for Salmonella. The pathogen 
reduction performance standards apply to 2,682 slaughter establishments 
and another estimated 2,840 establishments that produce raw ground 
product but do not have slaughter operations.
    The final rule also requires that all slaughter establishments test 
for generic E. coli to verify process control for fecal contamination 
during slaughter and sanitary dressing. Results will be measured 
against performance criteria established from the national baseline 
surveys. Under this final rule, the 2,682 inspected slaughter 
establishments will be required to verify by microbial testing that 
they are controlling their slaughter and sanitary dressing processes in 
accordance with the performance criteria. The rule establishes testing 
frequencies based on production levels, but does not establish the 
performance criteria as enforceable regulatory standards. As the 
preamble points out, the criteria will be flexible and subject to 
change 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 controls for slaughter and sanitary 
dressing procedures.
    The objective of this regulation is to reduce the risk of foodborne 
illness from meat and poultry. The focus is on reducing and eventually 
minimizing the risk from the following four pathogens:
     Campylobacter jejuni/coli.
     Escherichia coli O157:H7.
     Listeria monocytogenes.
     Salmonella.
    This document is the final Regulatory Impact Analysis (RIA) 
prepared in compliance with the provisions of Executive Order 12866 and 
analyses requirements of the Regulatory Flexibility Act (P.L. 96-354) 
and the Unfunded Mandates Reform Act (P.L. 104-4). The purpose of this 
final RIA is to evaluate alternatives to and costs and benefits 
associated with a mandatory HACCP-based regulatory program for all meat 
and poultry establishments under inspection.

B. Methodology

    The methodology used to develop cost estimates for this final RIA 
is relatively straightforward. The costs estimates are based on data 
for average wages, the cost of specific processing equipment or the 
cost of conducting specific laboratory analyses.
    The benefits analysis is less straightforward. The analysis has 
defined regulatory effectiveness as the percentage of pathogens 
eliminated at the manufacturing stage. The benefits analysis concludes 
that there is insufficient knowledge to predict with certainty the 
effectiveness of the proposed rule. Without specific predictions of 
effectiveness, FSIS has calculated projected health benefits for a 
range of effectiveness levels.
    The link between regulatory effectiveness and health benefits is 
the assumption that a reduction in pathogens leads to a proportional 
reduction in foodborne illness. FSIS has presented the proportional 
reduction calculation as a mathematical expression that facilitates the 
calculation of a quantified benefit estimate for the purposes of this 
final RIA. FSIS has not viewed proportional reduction as a risk model 
that would have important underlying assumptions that merit discussion 
or explanation. For a mathematical expression to be a risk model, it 
must have some basis or credence in the scientific community. That is 
not the case here. FSIS has acknowledged that very little is known 
about the relationship between pathogen levels at the manufacturing

[[Page 38946]]

stage and dose, i.e., the level of pathogens consumed.
    There are many factors that play important roles in the actual link 
between pathogen levels at the manufacturing stage and frequency of 
foodborne illness. First, the effectiveness definition of ``percentage 
of pathogens reduced'' can refer to the percentage of packages that 
contain pathogens or the level of pathogens within packages. The 
pathogens-to-illness relationship is further complicated because cross-
contamination in kitchens is believed to play a major role. It can not 
be assumed that a reduction in the number of pathogens present in a 
package of meat or poultry will prevent a cross-contamination related 
illness. On the other hand, given that the number of consumed pathogens 
necessary to cause illness (threshold) can be different for every 
possible pathogen or individual combination, a reduction in pathogen 
levels at the time of packaging may prevent illness for many cross-
contamination scenarios.
    These types of unknowns illustrate why the relationship between 
pathogen levels and foodborne illness levels remains unknown. As stated 
above, without a known relationship, FSIS has used the proportional 
reduction assumption to provide a quantified estimate, recognizing that 
the real relationship is probably different for each pathogen and 
category of meat and poultry product.
    Risk minimization as the objective of this rule means the 
elimination of most foodborne illness caused by the contamination of 
meat and poultry products in inspected establishments by any of the 
four pathogens listed above. The reduction in pathogens needed to do 
this is unknown and would vary for individual pathogens and products.
    This final RIA includes a discussion of the status of risk 
assessment for foodborne pathogens that responds to the new 
Departmental guidelines for preparing risk assessments contained in 
Departmental Regulation 1521-1, December 21, 1995. Although the 
statutory requirements for risk analysis included in the Federal Crop 
Insurance Reform and Department of Agriculture Reorganization Act of 
1994 (P.L. 103-354) do not apply to this final rule, there were public 
comments on the need for additional risk assessment or risk analysis. 
This final RIA includes the Agency's response to those comments.
    On February 3, 1995, FSIS published a preliminary RIA as part of 
the proposed Pathogen Reduction HACCP rule (60 F.R. 6871). The 
preliminary RIA announced the availability of a detailed supplemental 
cost analysis, titled ``Costs of Controlling Pathogenic Organisms on 
Meat and Poultry,'' which was available from the FSIS Docket Clerk 
during the comment period. This final RIA will refer to the analysis 
published with the proposed rule and the supplemental cost analysis 
collectively as the ``preliminary analysis.''
    During the public comment period the Department conducted a number 
of public hearings, technical conferences and information briefings. On 
May 22, 1995, the Agency conducted a special hearing in Kansas City 
dealing with the impacts of the proposed rule on small businesses. In 
July 1995, FSIS conducted a survey of the State inspection programs to 
collect additional information to assess the impact on State 
establishments.
    This final RIA is based on the preliminary RIA, the supplemental 
cost analysis, all written public comments, the records from public 
hearings including the meeting on small business impacts, the survey of 
State programs, and any new information or data that have become 
available during the comment period. The analysis also refers 
specifically to cost estimates developed by the Research Triangle 
Institute (RTI) during personal interviews with nine establishments 
that previously participated in the FSIS HACCP Pilot Program. The RTI 
report, HACCP Pilot Program Cost Findings, August 31, 1994, which was 
referred to in both written and public hearing comments were developed 
under contract to FSIS in 1994.

C. Summary Comparison of Costs and Benefits--Proposal to Final

    FSIS estimated that the proposed rule would have 20-year industry 
costs of $2.2 billion. Those costs are presented in Table 1, organized 
by the regulatory components identified in the proposal.
    The estimated costs for the final rule are also presented in Table 
1. For some of the regulatory components, it is easy to track the costs 
from the proposal to the final rule. For example, the costs for 
Sanitation SOP's remain essentially the same. The reduction from $175.9 
to $171.9 million reflects the change in implementation period from 90 
days to six months.
    The costs for developing and implementing HACCP plans are also 
directly comparable. The estimated cost has increased for the HACCP 
component of plan development. FSIS has increased its estimate for this 
cost after reviewing the public comments and assessing the overall 
impact on plan development costs of the decisions to eliminate the 
requirements for implementing time/temperature and antimicrobial 
treatment requirements prior to HACCP implementation. In the 
preliminary analysis, the cost for developing HACCP plans was reduced 
because of the experience that establishments would have gained in 
developing their plans for implementing time/temperature and 
antimicrobial treatment requirements.

                                Table 1.--Comparison of Costs--Proposal to Final                                
                                  [$ Millions--Present Value of 20-year Costs]                                  
----------------------------------------------------------------------------------------------------------------
     Regulatory component                         Proposal                                   Final              
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's..........  175.9a........................................  171.9                            
II. Time/Temperature           45.5..........................................  0.0                              
 Requirements.                                                                                                  
III. Antimicrobial Treatments  51.7..........................................  0.0                              
IV. Micro Testing............  1,396.3b......................................  174.1                            
V.                                                                                                              
    Compliance with            Not Separately Estimatedc.....................  55.5-243.5                       
     Salmonella standards.                                                                                      
    Compliance with generic    Not Applicable................................  Not Separately Estimated         
     E. coli criteria.                                                                                          
VI. HACCP:                                                                                                      
    Plan Development.........  35.7..........................................  54.8                             
    Annual Plan Reassessment.  0.0...........................................  8.9                              
    Recordkeeping (Recording,  456.4.........................................  440.5d                           
     Reviewing and Storing                                                                                      
     Data).                                                                                                     
    Initial Training.........  24.2..........................................  22.7d                            
    Recurring Training.......  0.0...........................................  22.1e                            
VII. Additional Overtime.....  20.9..........................................  17.5d                            
                              ----------------------------------------------------------------------------------

[[Page 38947]]

                                                                                                                
      Subtotal--Industry       2,206.6.......................................  968.0-1,156.0                    
       Costs.                                                                                                   
VIII. FSIS Costs.............  28.6f.........................................  56.5                             
                              ----------------------------------------------------------------------------------
      Total..................  2,235.2.......................................  1,024.5-1,212.5                  
----------------------------------------------------------------------------------------------------------------
a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted  
  because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days  
  after publication.                                                                                            
b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat  
  and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and 
  raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the        
  proposed sampling requirements.                                                                               
c The preliminary analysis accounted for some of the cost of complying with the new standards under the         
  regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.      
d These costs are slightly different from the proposal because of changes in the implementation schedule.       
e FSIS added costs for recurring training based on the review of public comments.                               
f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP    
  verification testing.                                                                                         


    Table 1 shows that FSIS has added two categories of HACCP costs 
that were not included in the preliminary cost analysis. A cost for 
recurring annual HACCP training was added in response to comments that 
there would be recurring costs because of employee turnover. FSIS also 
added a minimal cost for annual reassessment of HACCP plans, although 
the Agency believes that reassessment will be negligible for 
establishments successfully operating under a HACCP plan.
    Table 1 shows that the proposed requirements for time and 
temperature specifications and antimicrobial treatments have not been 
included in the final rule. The preliminary analysis treated these 
items as interim costs that were incurred prior to HACCP 
implementation. For the time and temperature requirements, the 
preliminary analysis identified both one-time capital equipment costs 
and recurring recordkeeping costs. The time and temperature 
recordkeeping costs were assumed to become part of the HACCP 
recordkeeping costs. The recurring costs for antimicrobials were 
assumed to end with HACCP implementation. The preliminary analysis 
indicated that at the time of HACCP implementation, the slaughter 
establishments would make a decision on whether to continue the 
antimicrobial treatments and employ other methods to reduce the 
microbial load on carcasses. The preliminary analysis did not, however, 
include a cost component for either continuing the antimicrobial 
treatments or adding alternative pathogen reduction methods.
    Under the micro testing component, the final rule requires that all 
2,682 slaughter establishments implement microbial sampling programs 
using generic E. coli. The 20-year cost of this requirement is $174.1 
million. After HACCP implementation including validation that the E. 
coli performance criteria are being met, establishments may use 
alternate testing programs unless FSIS specifically objects. In 
addition, in the period prior to mandatory HACCP, FSIS will consider 
exemptions on a case-by-case basis for establishments that are 
currently using an alternative E. coli sampling frequency if the 
establishment can provide data demonstrating the adequacy of its 
existing program. The cost estimate of $174.1 million assumes that all 
slaughter establishments continue to test at the frequencies outlined 
in the final rule.
    Up to this point, all the costs discussed have been predictable in 
the sense that they refer to a specific requirement directing all 
establishments or a specific category of establishments to take a well-
defined action. FSIS has developed point estimates for all predictable 
costs. In contrast, the pathogen reduction performance standards for 
Salmonella do not prescribe a set of actions that establishments must 
take. Because the standards are set using the national prevalence 
estimates from the baseline studies, the Agency is also not able to 
predict how many establishments are already meeting the standards or 
how many will have to modify their current operations to comply.
    The cost analysis in Section V recognizes that the performance 
standards create a set of potential costs for 5,522 establishments, 
2,682 slaughter establishments and another estimated 2,840 
establishments that produce raw ground product but do not have 
slaughter operations. The analysis estimates potential costs by 
developing two scenarios that lead to a range of possible costs 
depending on how the different industry sectors will respond to the new 
standards and depending on how many establishments will need to modify 
their production processes in order to comply.
    Reducing pathogens for slaughter establishments involves either 
modifying the incoming animals or birds, improving the dressing 
procedures so as to reduce contamination during procedures such as hide 
removal and evisceration, or using interventions such as antimicrobial 
treatments to kill or remove the pathogens following contamination. For 
many establishments, the process of implementing HACCP programs may, by 
itself, improve the dressing procedures sufficiently to meet the new 
standards. Other establishments may have to choose between slowing 
production lines, modifying some attribute of their incoming live 
animals or birds, or adding post-dressing interventions such as the new 
steam vacuum process or antimicrobial rinses.
    The 2,840 raw ground processing operations will have to control 
their incoming ingredients either by conducting their own testing or by 
requiring that suppliers meet purchase specifications. The cost 
analysis also recognizes that even though the rule does not require the 
2,682 slaughter establishments to test for Salmonella, some 
establishments may conduct their own Salmonella testing programs to 
avoid failing a series of tests conducted by the Agency. Thus, it can 
be argued that the Agency's intent to implement establishment specific 
testing for Salmonella is indirectly requiring the industry to 
routinely monitor their Salmonella levels to assure they will be in 
compliance.
    As shown in Table 1, the two scenarios developed in the cost 
analysis lead to a range in cost estimates of $55.5 to $243.5 million 
to comply with the new pathogen reduction standards. Some of these 
costs are contained in the

[[Page 38948]]

Table 1 proposal costs of $51.7 for antimicrobial treatments and the 
$1,396.3 for micro testing that included the cost of having 5,522 
establishments conduct daily Salmonella testing for each species 
slaughtered and each variety of raw ground product produced.
    The two cost scenarios were developed to illustrate potential costs 
for compliance with standards established using the current pathogen 
prevalence as determined by the national baseline studies. These 
standards move the Agency's regulatory program in the direction of 
meeting the food safety objective of minimizing the risk of foodborne 
illness from pathogens that contaminate meat and poultry products. The 
Agency has stated its intent to establish tighter standards over time. 
The Agency recognizes that future tighter standards could impose a new 
set of compliance costs. To illustrate, where the use of hot water 
rinses may be adequate to assure compliance with the Salmonella 
standards as established for this rule, such rinses may not be adequate 
to assure compliance with future standards. Any change in the standards 
will, however, be implemented through additional rulemaking. At that 
time the Agency will have extensive data on the distribution of 
pathogens by establishment and better data on the cost and 
effectiveness of different interventions. These data enhancements will 
allow for improved cost analysis of future standard setting activities. 
Inspected establishments need to consider the Agency's overall food 
safety objectives when making decisions on capital investments designed 
to assure compliance with the food safety standards established by this 
rulemaking.
    The cost analysis in Section V also recognizes that the performance 
criteria for generic E. coli create a set of potential costs for 2,682 
slaughter establishments. A line for these costs is shown in Table 1 
along with the entry that these costs were not separately quantified.
    As discussed in Section V, the anticipated actions to comply with 
the generic E. coli criteria are the same as the anticipated actions to 
comply with the standards for Salmonella. FSIS has concluded that if 
the low cost scenario for Salmonella compliance proves to be more 
accurate, then the Agency would expect to see some compliance costs for 
the generic E. coli performance criteria. If the high cost scenario is 
correct, then the compliance actions taken to assure compliance with 
the Salmonella standards should also assure compliance with the generic 
E. coli criteria.
    Finally, Table 1 includes a cost of $17.5 million associated with 
additional overtime charges for inspection. While it is recognized that 
final decisions on the future of the Agency's Total Quality Control 
(TQC) program have not been made, this analysis includes a conservative 
impact assumption that the existing TQC regulations will be withdrawn.
    Both the preliminary and final analysis identify a maximum 
potential 20-year public health benefit from $7.13 to $26.59 billion 
that is tied to eliminating establishment-related contamination from 
four pathogens on meat and poultry. The contamination from these four 
pathogens at the manufacturing stage leads to an estimated annual cost 
of foodborne illness ranging from $0.99 billion to $3.69 billion. The 
maximum 20-year benefit results from eliminating this annual cost of 
foodborne illness beginning in the fifth year after publication. 
Although there is reason to believe significant benefits will be 
generated during the first four years, for analytical purposes FSIS 
used the conservative estimate that benefits do not begin until all 
establishments have HACCP systems in place and pathogen reduction 
standards for Salmonella apply to all establishments that slaughter or 
produce raw ground product.
    There are two principle reasons why benefits will begin to accrue 
before the fifth year. First, the HACCP requirements and Salmonella 
standards apply to large establishments at 18 months and small 
establishments at 30 months. The large slaughter establishments account 
for over 74 percent of total carcass weight. Second, the generic E. 
coli testing requirements are effective six months after publication. 
The generic E. coli results will provide both establishment management 
and inspection program personnel a tool by which to assess 
establishments' control over slaughter and sanitary dressing 
procedures. Although the generic E. coli criteria are not being 
established as regulatory standards, FSIS believes their use will lead 
to improved control over slaughter and sanitary dressing procedures 
which will, in turn, lead to reductions in fecal contamination and 
corresponding reductions in contamination by enteric pathogens. Rather 
than attempt to estimate the benefits associated with reduced 
contamination resulting from use of generic E. coli testing, this 
analysis has assumed public health benefits begin in the fifth year. By 
that time all establishments have had an opportunity to adjust their E. 
coli sampling programs based on their HACCP programs.
    The low and high estimates for potential benefits are due to the 
current uncertainty in estimates for incidence of foodborne illness and 
death. If the low potential benefit estimate is correct, the analysis 
shows that the new HACCP-based program must reduce pathogens by 15 to 
17 percent for benefits to outweigh projected costs. If the high 
estimate is the correct estimate, the new program needs to reduce 
pathogens by only 4 to 5 percent to generate net societal benefits.
    As discussed in Section III, there are other benefits to this rule 
that have not been quantified. Examples include increased public 
protection from physical hazards and the increased production 
efficiency that accompanies improved process control.
    In the preliminary analysis FSIS took the position that quantified 
pathogen reduction benefits were related to the overall proposed HACCP-
based regulatory program and that there was no way to distribute 
benefits among the five different components that made up the proposed 
rule. Under the proposed rule it was essentially impossible to 
determine the proportion of pathogen reduction benefits that could be 
attributable to the proposed pathogen reduction standards versus the 
proposed antimicrobial treatments or time-temperature requirements or 
the proposed mandatory HACCP programs. Given the revised structure of 
the final rule, this analysis attributes pathogen reduction benefits to 
the requirements that all establishments implement HACCP systems and 
that if those systems are implemented in slaughter establishments or 
establishments shipping raw ground product, they must have critical 
limits set to assure compliance with the new pathogen reduction 
standards for Salmonella. However, as discussed above, FSIS believes 
that pathogen reduction benefits will begin to occur when 
establishments start using the generic E. coli results to assess their 
control over slaughter and sanitary dressing procedures.
    FSIS believes that the Sanitation SOP's component of this final 
rule has significant benefits in terms of increased productivity for 
inspection resources. The HACCP component also has productivity 
benefits in addition to public health benefits. One of the reasons FSIS 
has not yet achieved a program that can focus appropriate resources on 
the risks of microbial pathogens is that in recent years

[[Page 38949]]

national budget problems have provided limited increases in Agency 
resources compared to the increase in its responsibilities generated by 
industry growth, the Federal takeover of more State programs, and new 
food production technologies and products. For most of its history, the 
inspection program was able to obtain additional resources when it took 
on new responsibilities. Now FSIS is faced with taking on new 
responsibilities with the same resources.
    The final rule is a necessary component of an FSIS management 
strategy that will raise the productivity of current resources so that 
the program can maintain all its consumer protection objectives. 
Raising productivity requires raising outputs, reducing inputs or any 
combination of the two that gets more done for less. Productivity can 
be increased in today's inspection program by: (1) focusing resource 
use on the basis of risk, giving the highest priority to safety 
objectives; (2) clarifying the respective responsibilities of 
government and industry to assure the best use of government resources; 
and (3) designing new methods of inspection that are more efficient 
than existing inspection but which maintain or improve consumer 
protection.
    The Sanitation SOP's and HACCP requirements are designed to 
accomplish objectives in all three of the above areas. With SOP's FSIS 
can monitor sanitation plans with fewer resources than it takes to 
conduct comprehensive sanitation reviews. The benefit of the SOP's is, 
therefore, the capacity to reallocate inspection resources to other 
activities where the payoff in terms of reducing the risk of foodborne 
illness may be greater. With SOP's there is less likelihood that 
establishments will be able to substitute the inspector's sanitation 
review for their own sanitation program. Similarly, with HACCP there is 
less likelihood that firms can use inspection as a substitute for their 
own control programs. In both cases productivity is enhanced by 
clarifying responsibilities. The benefits associated with increased 
productivity are difficult to quantify because the precise reallocation 
of inspection resources is not yet clear.
    Finally, with the implementation of this rule, FSIS intends to 
introduce new methods of inspection that are more efficient than those 
currently in place. As noted above, more efficient methods is the third 
way in which productivity can be increased in the inspection system.

II. Regulatory Alternatives

A. Market Failure

    Consumers make choices about the food they purchase based upon 
factors such as price, appearance, convenience, texture, smell, and 
perceived quality. In an ideal world, people would be able to make 
these decisions with full information about product attributes and 
choose those foods which maximize their satisfaction. In the real 
world, however, information deficits about food safety complicate 
consumer buying decisions.
    Since all raw meat and poultry products contain microorganisms that 
may include pathogens, raw food unavoidably entails some risk of 
pathogen exposure and foodborne illness to consumers. However, the 
presence and level of this risk cannot be determined by a consumer, 
since pathogens are not visible to the naked eye. Although they may 
detect unwholesomeness from obvious indications such as unpleasant odor 
or discoloration caused by spoilage microorganisms, consumers cannot 
assume products are safe in the absence of spoilage. They simply have 
no clear-cut way to determine whether the food they buy is safe to 
handle and eat.
    When foodborne illness does occur, consumers often cannot correlate 
the symptoms they experience with a specific food because some 
pathogens do not cause illness until several days, weeks or even months 
after exposure. Thus, food safety attributes are often not apparent to 
consumers either before purchase or immediately after consumption of 
the food. This information deficit also applies to wholesalers and 
retailers who generally use the same sensory tests--sight and smell--to 
determine whether a food is safe to sell or serve.
    The societal impact of this food safety information deficit is a 
lack of accountability for foodborne illnesses caused by preventable 
pathogenic microorganisms. Consumers often cannot trace a transitory 
illness to any particular food or even be certain it was caused by 
food. Thus, food retailers and restaurateurs are generally not held 
accountable by their customers for selling pathogen-contaminated 
products and they, in turn, do not hold their wholesale suppliers 
accountable.
    This lack of information applies equally to small businesses. Some 
small businesses have argued for exemption from the rule because they 
sell most of their product to family, friends and neighbors, but they 
are overlooking the fact that perhaps the majority of foodborne illness 
victims may believe they had some type of flu virus or other illness 
and have no idea that their illness was foodborne and, if they do, they 
have no idea as to the source. Without feedback, (i.e., without a 
connection of product to illness), there is no market where buyers and 
sellers have sufficient information upon which to judge purchase 
decisions. Without feedback there is insufficient incentive to make 
substantial improvements in process control.
    This lack of marketplace accountability for foodborne illness means 
that meat and poultry producers and processors have little incentive to 
incur extra costs for more than minimal pathogen controls. The 
widespread lack of information about pathogen sources means that 
businesses at every level from farm to final sale can market unsafe 
products and not suffer legal consequences or a reduced demand for 
their product. An additional complication is that raw product is often 
fungible at early stages of the marketing chain. For example, beef from 
several slaughterhouses may be combined in a batch of hamburger 
delivered to a fast food chain. Painstaking investigation by public 
health officials in cases of widespread disease often fails to identity 
foodborne illness causes; in half the outbreaks the etiology is 
unknown.
    Most markets in industrialized economies operate without close 
regulation of production processes in spite of consumers having limited 
technical or scientific knowledge about goods in commerce. Branded 
products and producer reputations often substitute for technical or 
scientific information and result in repeat purchases. Thus, brand 
names and product reputations become valuable capital for producers.
    In the U.S. food industry, nationally recognized brand names have 
historically provided significant motivation for manufacturers to 
ensure safe products. In recent years, more and more raw meat and 
poultry have come to be marketed under brand names. Nevertheless, not 
even all brand name producers produce their products under the best 
available safety controls. Further, a significant part of meat and 
poultry, particularly raw products, are not brand name products and are 
not produced under conditions that assure the lowest practical risk of 
pathogens.
    The failure of meat and poultry industry manufacturers to produce 
products with the lowest risk of pathogens and other hazards cannot be 
attributed to a lack of knowledge or appropriate technologies. The 
science and technology required to significantly

[[Page 38950]]

reduce meat and poultry pathogens and other hazards is well 
established, readily available and commercially practical.
    Explanations for why a large portion of the meat and poultry 
industry has not taken full advantage of available science and 
technology to effectively control manufacturing processes include the 
following:
    1. Meat and poultry processing businesses are relatively easy to 
enter; there are no training or certification requirements for 
establishment operators. Consequently, the level of scientific and 
technical knowledge of management in many establishments is minimal.
    2. The industry is very competitive and largely composed of small 
and medium-sized firms that have limited capital and small profits.
    3. Management in many of these establishments has little incentive 
to make capital improvements for product safety because results from 
that investment are not distinguishable by customers and therefore 
yield no income.
    In spite of these barriers, many industry establishments do produce 
meat or poultry products using process controls that assure the lowest 
practical risk of pathogens and other hazards.
    FSIS has concluded that the lack of consumer information about meat 
and poultry product safety and the absence of adequate incentives for 
industry to provide more than minimal levels of processing safety 
represents a market failure requiring Federal regulatory intervention 
to protect public health.

B. General Regulatory Approaches

    The problem of microbial pathogens in meat and poultry has become 
increasingly apparent. Documented cases of foodborne illness each year, 
some of which have resulted in death, represent a public health risk 
that FSIS judges to be unacceptable. Within existing authorities there 
are four broad regulatory approaches the Department could use to 
address this unacceptable public health risk.
     Market Incentives.
     Information and Education.
     Voluntary Industry Standards.
     Government Standards.
    The final rule represents the fourth approach.
    The above discussion on market failure summarizes why FSIS has 
concluded that the market will not address the public health risk 
resulting from microbial pathogens in meat and poultry.
    The role and effectiveness of consumer and food service worker 
education in assuring food safety was raised in public comments. For 
example, comments suggested that since most foodborne illness involves 
temperature abuse or consumer/food handler mishandling, consumer 
education offers the most cost-effective approach. FSIS sees a clear 
role for education and agrees that education is essential for assuring 
food safety. However, experience has shown that education alone has 
limited effectiveness in reducing foodborne illness. The effectiveness 
of education for food safety, and, indeed, for improving diets and 
other food related behavior, has not been demonstrated. FSIS views 
education as a valuable adjunct to other regulatory approaches, but it 
has no evidence that a major increase in education expenditures will 
produce the behaviors required to reduce foodborne illness.
    A voluntary industry standard would call for the formation of a 
standards setting group, such as the American National Standards 
Institute (ANSI) to develop and publish a voluntary standard. 
Compliance with such a voluntary standard would be determined by third-
party testing and certification. For example, Underwriter's Laboratory 
(UL) tests and certifies electronic components for industry-wide 
standards. FSIS has not seen any evidence that the industry is prepared 
to undertake, or even desires a voluntary standards approach. This is 
understandable. Because the principles underlying the safe production 
of meat and poultry are the same regardless of who administers the 
standards, an industry administered system is likely to be more 
expensive and less effective than a government one. The lack of power 
to mandate participation reduces the value of standard setting to 
participants, since foodborne illness episodes attributable to non-
participants tend to raise suspicion of all similar products. Further, 
the industry would be called upon to pay the enforcement cost which 
under the present rule would be paid by the government.
    For these reasons, the Department concludes that mandatory process 
control regulations offer the best approach for addressing this 
unacceptable public health risk.

C. Need For Improved Process Control

    FSIS has determined that effective process control is needed 
throughout the meat and poultry industry in order to minimize pathogen 
contamination and control other health hazards. Accordingly, a 
regulatory strategy has been formulated to mandate process control 
improvements to achieve immediate reductions and an eventual 
minimization of the risk of meat and poultry pathogens, chemical, and 
physical hazards in the nation's food supply. This strategy is 
supported by consumers, scientists, and the majority of meat and 
poultry industry processors who already recognize the benefits of good 
process control.
    Process control is a proactive strategy that all segments of 
industry can undertake to anticipate manufacturing problems in advance 
and prevent unsafe foods from being produced. In practice, process 
control is a systematic means to:
     Identify and control production hazards.
     Determine control points in the processing system.
     Establish standard measures for each control point.
     Set procedures for establishment workers to monitor 
requirements.
     Provide clear instructions for appropriate corrective 
actions when a control point goes out of control.
     Establish record-keeping to document control point 
measurements.
     Provide procedures for verification tests to ensure that 
the system continues to operate as planned.
    The process control strategy summarized in this paper is founded on 
three principles:
    1. USDA regulatory policy should be focused on providing a solution 
to meat and poultry biological, chemical, and physical hazards that 
present the highest public health risks.
    2. It is essential that the Nation's food safety system address 
pathogenic microorganisms which present the greatest foodborne risk to 
human health.
    3. These pathogens and resulting risks of foodborne illness can be 
largely avoided by uniform meat and poultry industry efforts to attain 
and maintain more effective methods of control during the manufacturing 
process.
    The focus of this strategy is explicitly on prevention; it is 
designed to prevent the production of defective product as opposed to 
more costly and less effective detect-and-condemn methods.
    Process control is not a substitute for inspection any more than 
inspection could be a substitute for process control. This distinction 
is important because Federal inspection was never intended to be--and 
cannot be--the front-line control for food safety in meat and poultry 
processing establishments. Safety controls must be built into the 
manufacturing process and be administered continuously by industry. The 
objective of inspection in a process control environment is to assure 
that those controls are present, adequate, and properly used.

[[Page 38951]]

    To summarize, the process control regulatory strategy promulgated 
by this rule will among its other well established attributes, correct 
two important deficiencies in the nation's current food safety effort. 
It will: (1) provide industry the tools and incentive to reduce meat 
and poultry pathogens as a means to improve food safety, and (2) help 
focus Federal inspection on the highest product, process and 
establishment risks, and, at the same time, clarify that the industry 
is responsible for producing safe meat and poultry, while the 
Government's role is oversight.
Factors Considered in Evaluating a Process Control Strategy
    The process control regulatory strategy was evaluated using five 
factors for effectiveness. A processing control program is effective if 
it:
    1. Controls production safety hazards.
    2. Reduces foodborne illness.
    3. Makes inspection more effective.
    4. Increases consumer confidence.
    5. Provides the opportunity for increased productivity.
    The following sections discuss these five effectiveness factors 
that have been applied to evaluate process control alternatives.
Controls Production Safety Hazards
    Process control is a system for identifying food hazards and 
reducing or eliminating the risks they present. In operation, control 
points are established in a food production line where potential health 
hazards exist; management of these points has proven to be effective in 
reducing the probability that unsafe product will be produced. Ongoing 
records of each process control will enable establishment managers and 
quality control personnel to spot trends that could lead to problems 
and devise a strategy that prevents them before they occur.
    Detection by end product testing is not a viable alternative to 
process control because it only sorts good product from bad and does 
not address the root cause of unacceptable foods. Additionally, keeping 
``bad'' foods out of commerce through sorting end product is possible 
only when tests and standards for sampling are well established and it 
is practical only where the ``test'' is not expensive because sorting 
requires a huge number of samples for reliability.
Reduces Foodborne Illness
    As industry improves its control over the safety aspects of meat 
and poultry production, foodborne illness will begin to decline. This 
is the principal non-negotiable goal for both USDA and industry.
    The precise occurrence of human health problems attributed to 
pathogenic microorganisms or other potential foodborne hazards, such as 
chemical contaminants, animal drug residues, pesticides, extraneous 
materials, or other physical contaminants is not known. Foodborne 
illness is nevertheless recognized by both domestic and international 
scientists as a significant public health problem and there is wide 
agreement that pathogenic microorganisms are the major cause of food-
related disease. The estimated annual (not discounted) cost of 
foodborne illness attributable to meat and poultry products from the 
four pathogens that are the focus of this regulation is from $1.1 to 
$4.1 billion. FSIS estimates that 90 percent of this annual cost, $0.99 
to $3.69 billion, is attributable to contamination that occurs in 
establishments.
Makes Inspection More Effective
    Currently, the FSIS inspectors in meat and poultry establishments 
that are not assigned to slaughter line positions perform selected 
inspection tasks that generate independent data about an 
establishment's production processes and environment. This activity 
produces ``snapshots'' of establishment operations at a particular 
moment. In contrast, process control generates records of establishment 
performance over time. These records and periodic verification 
inspections will enable FSIS inspectors to see how an establishment 
operates at all times, i.e., whether and where processing problems have 
occurred, and how problems were addressed.
    The availability of more and better processing data will establish 
trends that set benchmarks from which deviations can be more quickly 
and accurately assessed. USDA inspectors will be trained to spot these 
deviations and take action when needed to ensure establishments bring a 
faulty process back into control. This type of Federal oversight is 
substantially more effective than a regulatory program that merely 
detects and condemns faulty end products. In the words of the National 
Advisory Committee on Microbiological Criteria for Foods, 
``Controlling, monitoring, and verifying processing systems are more 
effective than relying upon end-product testing to assure a safe 
product.''
Increases Consumer Confidence
    The number of foodborne illness outbreaks and incidents 
attributable to pathogens in meat or poultry raise questions about 
whether Federal inspection is as effective as it should be. Highly 
visible public controversies about meat and poultry inspection indicate 
an erosion of public confidence in the safety of meat and poultry 
products. There are growing demands that USDA improve its regulation of 
pathogens. The process control regulatory strategy described in this 
paper is USDA's response to those demands.
    Many outbreaks of foodborne illness have been determined to be 
caused by mishandling of meat and poultry products after federally 
inspected processing. USDA believes that additional efforts to reduce 
pathogens during manufacturing will reduce these risks as well. This 
coupled with the improved retail regulatory controls from state 
adoption and enforcement of the Food Code should reduce this cause of 
illness. The Food Code is an FDA publication, a reference that provides 
guidance to retail outlets such as restaurants and grocery stores and 
institutions such as nursing homes on how to prepare food to prevent 
foodborne illness. State and local regulatory bodies use the FDA Food 
Code as a model to help develop or update their food safety rules and 
to be consistent with national food regulatory policy.
    A significant portion of the meat and poultry industry do not take 
advantage of readily available methods to control their manufacturing 
processes. The Department has concluded that further regulation will 
bring industry standards up to what can practically be achieved in the 
manufacture of meat and poultry products through current scientific 
knowledge and available process control techniques. Raising the safety 
floor through regulations that mandate better process control will 
demonstrate to the public that USDA and industry are making a concerted 
effort to reduce the risk of foodborne illness from meat and poultry.
    The economic benefits of increased consumer confidence can be 
conceptually realized as the amount consumers would be willing to pay 
for safer food. This ``willingness to pay'' reflects consumer desires 
to avoid foodborne illness and the expected medical and other costs 
associated with it. However, the data are not available to make 
quantitative estimates of this benefit.
Provides the Opportunity for Increased Productivity
    Better process control is a sound and rational investment in the 
future of our

[[Page 38952]]

nation's meat and poultry industry. USDA's process control strategy 
will educate industry management about the need and methodology for 
development of a consistent, preventive, problem-solving approach to 
safety hazards, which can be expanded to other business objectives such 
as product quality and production efficiency. There is considerable 
evidence of how process control has improved worldwide industrial 
productivity in the past 40 years. This proposal will extend process 
control principles to parts of the meat and poultry industry that have 
not formerly used them.
    Some important non-safety benefits that will accrue from industry 
use of better process control methods are:
     First, better production controls will result in more 
efficient processing operations overall with fewer product defects. 
Fewer defects mean less reworking, waste and give-away, resulting in 
increased yields and more profit opportunities.
     Second, better controls will significantly reduce the risk 
to processors that product with food safety defects will slip into 
commerce. Expensive and embarrassing product recalls can be, for the 
most part, avoided or greatly reduced with proper process controls.
     Third, better control of pathogens will impact all 
microorganisms, including those responsible for decomposition, 
resulting in quality improvement and longer shelf life for products.
     Fourth, better production controls improve establishment 
employee productivity which improves profit opportunities.

D. Regulatory Alternatives for Process Control

1. Mandatory HACCP
    Considering the five effectiveness criteria of process control 
discussed above, the most effective means for generating the benefits 
reflected in these criteria is a mandatory HACCP regulatory program. 
This alternative clearly meets all five criteria described above. In 
fact, a mandatory HACCP program was judged to be the only option that 
will effect adequate processing improvements in all establishments 
throughout the industry. Only through mandatory HACCP can pathogen 
risks be minimized to the fullest extent possible; thereby 
significantly reducing foodborne illness, improving effectiveness of 
inspection, increasing consumer confidence, and ensuring a more viable 
industry. No other alternative accomplishes as much in these five areas 
as mandatory HACCP.
    HACCP is a process control strategy that has been scientifically 
proven effective in food manufacturing establishments. HACCP is widely 
recognized by scientific authorities such as the National Academy of 
Sciences and international organizations such as the Codex 
Alimentarius. It is used today by a number of establishments in the 
food industry to produce consistently safe products. This approach has 
been supported for years by numerous groups that have studied USDA meat 
and poultry regulatory activities.
    In 1983 FSIS asked the National Academy of Sciences (NAS) to 
evaluate the scientific basis of its inspection system and recommend a 
modernization agenda. The resulting report, ``Meat and Poultry 
Inspection, The Scientific Basis of the Nation's Program,'' National 
Academy Press, 1985 was the first comprehensive evaluation of a 
scientific basis for inspection. The 1985 NAS report provided a 
blueprint for change: it recommended that FSIS focus on pathogenic 
microorganisms and require that all official establishments operate 
under a HACCP system to control pathogens and other safety hazards.
    After urging (NAS Recommendations, Page 4) the intensification of 
``current efforts to control and eliminate contamination with micro-
organisms that cause disease in humans,'' NAS encouraged (Page 135) 
USDA to ``move as vigorously as possible in the application of the 
HACCP concept to each and every step in establishment operations, in 
all types of enterprises involved in the production, processing, and 
storage of meat and poultry products.''
    The General Accounting Office (GAO) has also identified needed 
improvements in USDA's present inspection system. In its reports and 
congressional testimony, and in numerous publications, GAO has endorsed 
HACCP as the most scientific system available to protect consumers from 
foodborne illness. This sentiment is most clearly expressed in a May 
1994 report, ``Food Safety: Risk-Based Inspections and Microbial 
Monitoring Needed for Meat and Poultry,'' in which GAO recommended 
development of a mandatory HACCP program that includes microbial 
testing guidelines. GAO urged USDA to assist meat and poultry 
establishments in the development of their microbial testing programs 
by, among other things, disseminating information on the programs 
already in operation.
    A third major proponent of HACCP is the National Advisory Committee 
on Microbiological Criteria for Foods (NACMCF), which was established 
in 1988 by the Secretary of Agriculture to advise and provide 
recommendations to the Secretaries of Agriculture and Health and Human 
Services on developing microbiological criteria to assess food safety 
and wholesomeness. Since 1989, NACMCF has prepared a series of reports 
on the development and implementation of HACCP. As one of its first 
tasks, the Committee developed ``HACCP Principles for Food Production'' 
in November 1989. In this report, the Committee endorsed HACCP as a 
rational approach to ensure food safety and set forth principles to 
standardize the technique. In 1992, the Committee issued an updated 
guide, ``Hazard Analysis and Critical Control Point System.''
    In 1993 NACMCF defined the roles of regulatory agencies and 
industry in implementing HACCP. ``The Role of Regulatory Agencies and 
Industry in HACCP'' proposed responsibilities for FDA, USDA, and other 
agencies and industry during various phases of HACCP implementation. 
Similar suggestions for program change have been voiced by consumers, 
industry, state and local government representatives, as well as other 
constituent groups. For example, consumers at recent public hearings 
and the HACCP Round Table supported implementation of mandatory HACCP 
throughout the meat and poultry industry.
    The meat and poultry industry has itself provided broad support for 
HACCP as a means to control pathogens, emphasizing that HACCP-based 
food production, distribution, and preparation can do more to protect 
public health than any Federal inspection program. They have 
recommended that HACCP be used to anticipate microbiological hazards in 
food systems and to identify risks in new and traditional products. 
State departments of health and agriculture have also endorsed the 
HACCP approach.
2. Alternatives to Mandatory HACCP
    FSIS examined six other approaches before determining that 
mandatory HACCP was the most effective means for assuring process 
control in the meat and poultry industries.
    1. Status quo
    2. Intensify present inspection
    3. Voluntary HACCP regulatory program
    4. Mandatory HACCP regulation with exemption for small businesses
    5. Mandatory HACCP regulation only for ready-to-eat products

[[Page 38953]]

    6. Modified HACCP--recording deviations and responses only
    These alternatives were assessed using the five effectiveness 
criteria presented in the previous section. The following six sections 
summarize the appraisal of each alternative.
Status Quo
    This option would essentially continue establishment processing 
controls and Federal inspection as they are now. Good establishments 
with adequate methods for managing process lines would probably remain 
under control. The Agency, under its present authority, cannot shift 
resources out of good establishments so the situation of poor 
performing establishments is unlikely to change. This situation raises 
immediate questions about the first factor--controls production safety 
hazards--being met. Experience has proven that Federal inspection 
cannot substitute for management in establishments which have 
difficulty producing safe product consistently. Also, inspection cannot 
be as effective in the current establishment environment as in a 
process control establishment environment.
    The status quo does not target industry and inspection resources on 
those hazards that lead to the greatest reduction in foodborne illness 
(factor two). In addition, food safety experts, consumers, and other 
observers have told USDA they are not satisfied with pathogen control 
by organoleptic methods as practiced in the present inspection program. 
Doing nothing new would perpetuate consumer doubts about the ability of 
Federal inspection to regulate pathogens which is counter to factor 
four. Consequently, the Department has concluded that business as usual 
is not an acceptable response to pathogens associated with meat and 
poultry products. Agency public health responsibilities alone require 
that more positive actions be taken.
Intensify Present Inspection
    As one alternative to the proposed mandatory HACCP regulation, FSIS 
could intensify its present inspection system, i.e., focus new 
resources on suspected areas of risk in each establishment. This 
approach would assign to FSIS responsibility for designing, testing and 
mandating by specific regulation, process control systems for all meat 
and poultry products with potential safety hazards. A major flaw with 
this approach is that the burden of ensuring a safe product would be 
placed largely on FSIS instead of industry establishments where it 
belongs. Establishment management would have little motivation to 
become knowledgeable about process control or to implement process 
control systems.
    The mandating of specific process controls has sometimes succeeded, 
as a regulatory strategy, for example, in correcting food safety 
problems in certain ready-to-eat products. However, these controls 
largely consisted of lethal heat treatments applied during final 
product processing. This approach is obviously inappropriate for 
product that is marketed raw which is most frequently associated with 
meat and poultry foodborne illness. The identification of processes 
that can be applied to raw product in every establishment would be much 
more difficult, if not impossible. Thus, intensified command-and-
control regulation fails to meet the primary criterion for process 
control, i.e., control production safety hazards at all stages of meat 
and poultry slaughter and processing. Related to this failing, 
inspection would be ineffective without all establishments maintaining 
process control systems (factor three.) This option would not only 
require significant resource increases, it represents government taking 
on more, not less, responsibility for the production process, making it 
more difficult to focus on the highest risks of foodborne illness. With 
the burden of control and monitoring on USDA's inspection force rather 
than on establishment managers, industry performance in reducing 
foodborne illness would be unlikely to improve (factor two).
Voluntary HACCP Regulatory Program
    A voluntary HACCP program would not provide reduction of pathogens 
uniformly across the processing spectrum because many in industry would 
choose not to participate. Therefore voluntary HACCP would not be 
sufficient to attain the necessary reduction in foodborne illness 
(factor two).
    Voluntary HACCP would be implemented most frequently in 
establishments with good processing controls already, while 
establishments with unsophisticated controls would be less likely to 
participate. The explanation for this flaw is to be found in simple 
economics and, to a large degree, the attitudes of establishment 
management. Establishments with good processing controls now are most 
likely to adopt HACCP voluntarily because their management understands 
the linkage between how a product is handled during preparation and its 
finished quality and safety.
    Conversely, establishments without good processing controls today 
are much less likely to participate in a voluntary HACCP program. These 
establishments are more often operated by management that lacks the 
knowledge or motivation to institute better processing controls. 
Nevertheless, it is precisely this group of low performing 
establishments that FSIS must reach to attain its public health goal. 
Nothing short of a mandatory HACCP regulatory program will be effective 
in bringing processing improvements to these marginal performers.
    The Agency's regulation permitting the use of voluntary Total 
Quality Control (TQC) Systems provides a useful analogy to how 
effective a voluntary HACCP program would be. TQC focuses on 
establishment responsibility for meeting or exceeding the standards set 
by FSIS for all operations that are conducted in an establishment, 
including incoming raw materials, processing procedures, critical 
limits for product standards, and action limits for establishment 
quality control personnel. These systems operate under Agency oversight 
with an emphasis on timely and accurate recordkeeping and the necessity 
for appropriate action to be taken by an establishment when a limit set 
forth in an approved system is met or exceeded. However, over the last 
10 years the number of establishments with active TQC Systems has 
declined from a high of around 500 (approximately 8% of all 
establishments) to the present 351 participating establishments 
(approximately 5% of all establishments). USDA experience has shown 
that a voluntary approach to HACCP would provide little assurance that 
a major portion of meat and poultry products had been produced under 
controls designed to minimize food safety hazards.0
Mandatory HACCP Regulation With Exemption for Small Businesses
    Under this alternative, FSIS would mandate HACCP, but also provide 
an exemption for some category of small businesses as was done with 
nutrition labeling. While this final regulatory impact analysis does 
develop very specific definitions for small and very small 
establishments, the following discussion of comments uses the term 
``small'' in a generic sense because many of the comments address small 
establishments or small businesses without defining these terms. There 
was a mix of public comments on whether or not HACCP should be 
mandatory for small businesses.

[[Page 38954]]

    Comments supporting an exemption from HACCP for small 
establishments noted that many owner-operators of small establishments 
oversee the entire operation on a daily basis and can pay closer 
attention to procedures than can a large establishment. Similar 
comments pointed out that small establishments pose a minimal potential 
public health hazard because of the simplicity of their operations, the 
slow pace of operations, and the small number of potentially affected 
customers. Other comments pointed out that they sell their product to 
family, friends and neighbors and that type of market provides the 
greatest incentive for producing safe product.
    Some commenters opposing an exemption did not want to create a two-
tiered system. Others opposing an exemption for small establishments 
would require HACCP for everyone while easing the burden through 
flexibility of implementation. Several of the commenters opposing any 
type of exemption from HACCP identified themselves as owners of small 
establishments. One commenter noted that just because small businesses 
produce only 2 percent of the product does not mean they are 
responsible for only 2 percent of the foodborne illness attributable to 
meat and poultry.
    The Agency used the evaluative factors presented above to consider 
the application of the rule to small establishments. Since major goals 
in implementing HACCP are to improve processing controls and 
establishment performance across all of industry (factor one) as a 
means to achieve foodborne illness reduction (factor two), the option 
to exempt establishments that perform the least process control is 
inherently flawed. USDA inspection experience shows that some of the 
small establishments which would be exempted under this option have 
particular difficulties maintaining control over their processing 
system.
    While it is true that small establishments produce a minimal amount 
of the total meat and poultry supply, they do produce a full range of 
products, including those most frequently associated with foodborne 
illness from the meat and poultry supply.
    This option also fails on factor three--provide more effective 
inspection. Two different inspection systems would be needed: one risk-
based system to inspect HACCP establishments with good processing 
controls; the other to provide resource intensive coverage for 
establishments that largely do not. If the number of small 
establishments were to increase, more inspection resources would be 
required.
    For these reasons, the final rule does not include an exemption for 
small businesses. However, the Agency has made significant changes to 
ease the burden on small business, including basing microbial sampling 
programs on production volume and deferring implementation of mandatory 
HACCP for small and very small businesses as defined in Section V.
Mandatory HACCP Regulation Only for Ready-to-Eat Products
    This option would mandate HACCP only for establishments that 
prepare ready-to-eat meat and poultry products, but not for 
establishments that produce raw products. However, this decision would 
leave the public without adequate protection from pathogenic 
microorganisms clearly associated with product marketed in raw form. 
Very little reduction in the most frequent causes of foodborne illness 
(factor two) could be anticipated from this approach.
    Government inspection costs would continue to increase to provide 
traditional resource-intensive inspection for slaughtering and allied 
processing establishments that would not be subject to mandatory HACCP. 
Since most of the unsolved problems with pathogenic microorganisms are 
associated with raw product and not with those products that would be 
the subject of this HACCP option, this is an especially inappropriate 
regulatory approach.
Modified HACCP--Recording Deviations and Responses Only
    A final alternative considered would be to mandate HACCP, modified 
to eliminate the record keeping burden to the inspected industry, 
especially small establishments. Specifically, this option would modify 
the HACCP record-keeping principles so that instead of demanding 
continuous records at critical control points, companies would need to 
record only deviations from critical limits and the response to them. 
This would mean that HACCP-controlled operations would not generate 
continuous monitoring data to reflect the operation at critical control 
points, but would only record data when deviations occurred. This 
arrangement eliminates the continuous picture of establishment 
operations which is the underpinning of factor three--make inspection 
more effective.
    Such an approach would substantially reduce the paperwork burdens 
associated with mandatory HACCP as recommended by NACMCF and recognized 
by CODEX. However, it would also seriously compromise the usefulness of 
HACCP as a means to make inspection more effective and avoid program 
cost increases. Regulatory officials need to have a system which can be 
reviewed in its entirety, so that a comprehensive picture of the 
process is available, not just the truncated version which grows out of 
recording deviations.

E. Comments on Analysis of Regulatory Alternatives

    There were several general comments related to either the 
alternatives discussed in the proposed rule or the level of analysis 
conducted. There were comments noting that FSIS did not quantify the 
costs and benefits of the regulatory alternatives. Similar comments 
suggested that FSIS should have determined cost-benefit ratios for the 
processed food industry or for ready-to-eat products or for small 
businesses.
    Generating quantitative benefit estimates for different types of 
products or different industry sectors would be very difficult. The 
estimates for foodborne illness attributable to meat and poultry have 
not been broken down by industry sector or type of product. There are 
no existing estimates for the portion of foodborne illness attributable 
to meat versus poultry or raw product versus cooked or partially cooked 
product.
    Production volume can not be used as an indicator of potential 
benefits. Foodborne illness is not proportionally related to production 
volume because pathogen levels vary significantly by type of product. 
As noted above, a commenter also pointed out that just because small 
businesses account for only 2 percent of production does not mean that 
small businesses account for only 2 percent of foodborne illness.
    On the cost side, the estimates are, for the most part, based on 
industry averages. In reality, costs will vary by industry sector based 
on the hazards presented and the existing presence of process control. 
Thus, in response to a comment that suggests that few benefits are 
available from changing the process for the manufacture of processed 
foods which are now produced under a zero pathogen standard, the 
Department would suggest that the costs for implementing HACCP for 
these products will also be low. Many ready-to-eat products such as 
cooked patties and roast beef are presently produced under 
comprehensive process control regulations.
    One comment suggested that FSIS consider mandatory HACCP for only 
firms that produce raw meat and poultry products because that sector of 
the industry generates most of the problems

[[Page 38955]]

and would provide the greatest pathogen reduction benefits per dollar 
of cost expended. The same commenter found it odd that the Agency did 
include an alternative for mandatory HACCP for only ready-to-eat 
products after acknowledging that most of the unsolved problems with 
pathogenic microorganisms are associated with raw meat and poultry 
products, rather than ready-to-eat products. In the above discussion of 
regulatory alternatives, it was noted that mandatory HACCP for only 
ready-to-eat products is an especially inappropriate regulatory 
approach. In contrast, a raw product option appears attractive since 
most of the unsolved problems with pathogenic microorganisms are 
associated with raw product. Most establishments handle raw product 
ingredients or prepare a finished raw product. Most of the cost of this 
rule is associated with controlling the safety hazards of raw product 
production. Extending the rule to cover all production adds little cost 
while allowing a single inspection approach, avoiding confusion where 
raw product production ends and ready-to-eat production begins, and 
assuring that the potential hazard of recontaminating ready-to-eat 
product by contact with raw ingredients is always covered by 
comprehensive HACCP programs.
    Other comments noted that FSIS did not analyze an option that 
accounted for the savings associated with streamlining and modernizing 
the inspection system or that FSIS should revise the cost-benefit 
analysis to consider the savings from eliminating the current 
inspection program. The savings referred to will be used to focus on 
food safety risks that need more coverage.

III. Summary of Impacts

A. Introduction

    This section provides a summary of the costs and benefits that will 
be discussed in detail in Sections IV and V. The benefits analysis in 
Section IV and this summary discuss benefits in terms of the reduction 
in the cost of foodborne illness that results from reductions in 
pathogen levels. There are other public health benefits beyond the 
reduction of foodborne illness due to pathogenic bacteria. HACCP 
systems will also provide increased public protection from risks posed 
by chemical and physical hazards. There are also benefits beyond public 
health benefits. As discussed in Section I, the SOP and HACCP 
requirements have social benefits that derive from the capacity to 
reallocate inspection resources to other activities where the payoff in 
terms of reducing the risk of foodborne illness may be greater.
    The February 1995 proposal and the subsequent public comment 
recognized that the HACCP/Pathogen Reduction regulations would also 
generate benefits for meat and poultry processors. For example, a 
commenter at a public hearing provided confirmation that the insurance 
industry is aware of HACCP and has offered reduced liability insurance 
for firms with improved food safety controls. Other comments noted that 
improved production efficiency has always been associated with improved 
process control. Increased customer confidence can also be a benefit to 
the extent that it has a positive influence on demand.
    The benefits analysis in the preliminary RIA noted that benefits 
also accrue through the reduction of operating costs like the cost of 
product recalls or the cost of settling product liability claims. Other 
operating costs include the loss of establishment production due to 
suspensions for sanitation problems that could be reduced by improved 
process control, premiums for product liability insurance, loss of 
product reputation, and reduced demand when a foodborne illness 
outbreak is publicized identifying a product or company.
    The cost analysis in Section V addresses two types of costs 
associated with this rule. There are the predictable costs associated 
with requirements directing all establishments or a specific category 
of establishments to take a well-defined action. Examples include the 
requirements to develop SOP's and HACCP plans or the requirement to 
have access to a HACCP-trained individual. This final RIA provides 
point estimates for all predictable costs. There are also potential 
costs that may impact some establishments because of current 
establishment-specific situations. This analysis provides a range of 
potential costs developed from two different scenarios of possible 
establishment responses to new pathogen standards.
    This summary compares both types of costs with the potential public 
health benefits related to pathogen reduction, recognizing that there 
are other potential benefits. The discussion in Section V notes how 
this rule will set new requirements and also improve compliance with 
existing requirements. Some of the potential costs discussed in Section 
V are costs associated with improved compliance with existing standards 
and should not necessarily be considered costs of this rulemaking.
    Public comments demonstrate that the controversy in this rulemaking 
derives not from the benefit cost ratio itself, which is very 
favorable, but from the fact that the processors will bear most of the 
costs while the public, in general, will experience the benefits. The 
public includes both the consumers of meat and poultry and those who do 
not consume meat or poultry but who bear the costs of illness in the 
society. Another area of controversy arises from the lack of proof that 
the estimated benefits will result from the promulgation of the rule. 
These doubts are particularly troublesome to those who would have to 
make resource investments under the rule while benefits largely accrue 
to others. This is, of course, the standard controversy facing 
government regulators. The essence of government regulation is that 
there is a situation where the public undergoes unacceptable risk 
because the current distribution of costs and benefits is unlikely to 
change without government intervention. This rule represents the 
Department's belief that the food safety risks being borne by the 
public are unacceptable, that they can be reduced through the use of 
readily available current technologies, and that the uncertainties 
involved in just how much risks can be reduced should not prevent the 
Department from making its best effort to reduce the risks.

B. Net Benefit Analysis

    Because costs and benefits accrue at different rates over different 
time periods, to compare costs and benefits it is necessary to examine 
present value estimates for both cost and benefit streams. To make 
these comparisons, both the preliminary analysis and this final RIA use 
a 20-year time period. The present values for costs and benefits are 
based on a discount rate of 7 percent, the current standard recommended 
by the Office of Management and Budget.
    As discussed above, the cost analysis (Section V) addresses two 
types of costs. FSIS was able to develop point estimates for the direct 
costs of complying with the requirements outlined in the rule that all 
establishments must meet. These predictable costs include the costs of 
developing and operating HACCP plans and SOP's and the costs of 
required recordkeeping. There are also potential costs for 
establishments that may have to purchase new equipment, or modify their 
production practices to meet the pathogen reduction performance 
standards for Salmonella, or actually implement Salmonella testing 
programs to assure compliance with the new standards. The cost analysis 
develops a range of cost estimates for these potential costs.

[[Page 38956]]

    The estimated annual industry costs (not discounted) are summarized 
in Table 2. These annual costs vary over the first four years as the 
new HACCP-based program is undergoing its implementation phase. After 
the initial four years, the recurring costs are estimated at a constant 
$99.6 to $119.8 million per year. The present value of all industry 
costs summarized in Table 2 for the 20-year time period is $968 to 
$1,156 million as shown earlier in Table 1. This total of $968 to 
$1,156 million ($0.97 to $1.16 billion) is the total industry cost for 
the rule as shown in Table 3.

                                              TABLE 2.--Summary of Annual Industry Costs--All Requirements                                              
                                                                      [$ Thousands]                                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost Category                              Year 1             Year 2             Year 3             Year 4            Year 5+     
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's:                                                                                                                                    
    Plans and Training...................................              2,992                                                                            
    Observation and Recording............................              8,345             16,691             16,691             16,691             16,691
II. E. coli Sampling:                                                                                                                                   
    Plans and Training...................................              2,627                                                                            
    Collection and Analysis..............................              8,716             16,122             16,122             16,122             16,122
    Record Review........................................                406                752                752                752                752
III. Compliance with Salmonella Standards................  .................       5,472-16,899       5,353-25,753       5,811-25,956       5,811-26,079
    Compliance with Generic E. coli Criteria.............  .................              (\1\)              (\1\)              (\1\)              (\1\)
IV. HACCP:                                                                                                                                              
    Plan Development.....................................  .................              3,769             27,755             35,464  .................
    Annual Plan Reassessment.............................  .................  .................                 69                448              1,179
    Initial Training.....................................  .................              1,270              8,284             18,435  .................
    Recurring Training...................................  .................                 64                542              1,877              2,799
    Recordkeeping (Recording, Reviewing and Storing Data)  .................              3,050             18,479             42,478             54,097
V. Additional Overtime...................................  .................                189                837              1,711              2,125
                                                          ----------------------------------------------------------------------------------------------
      Total..............................................             23,086      47,379-58,806     94,884-115,284    139,789-159,934    99,576-119,844 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Not Separately Estimated.                                                                                                                           


         Table 3.-- Present Value of 20-Year Costs and Benefits         
                              [$ Billions]                              
------------------------------------------------------------------------
                                               Public health            
 Effectiveness in reducing pathogens in the      benefits      Industry 
       manufacturing sector (percent)        ----------------    costs  
                                                Low    High             
------------------------------------------------------------------------
10..........................................    0.71    2.66   0.97-1.16
20..........................................    1.43    5.32   0.97-1.16
30..........................................    2.14    7.98   0.97-1.16
40..........................................    2.85   10.64   0.97-1.16
50..........................................    3.57   13.30   0.97-1.16
60..........................................    4.28   15.96   0.97-1.16
70..........................................    4.99   18.61   0.97-1.16
80..........................................    5.71   21.27   0.97-1.16
90..........................................    6.42   23.93   0.97-1.16
100.........................................    7.13   26.59   0.97-1.16
------------------------------------------------------------------------

    Note: Analysis assumes zero benefits until year 5. All elements 
of the HACCP-based program will be in place 42 months after 
publication of the final rule.

    The public health benefits of this rule are discussed in detail in 
Section IV. The benefits are based on reducing the risk of foodborne 
illness due to Campylobacter jejuni/coli, Escherichia coli 0157:H7, 
Listeria monocytogenes and Salmonella. Section IV concludes that these 
four pathogens are the cause of 1.4 to 4.2 million cases of foodborne 
illness per year. FSIS has estimated that 90 percent of these cases are 
caused by contamination occurring at the manufacturing stage that can 
be addressed by improved process control. This addressable foodborne 
illness costs society from $0.99 to $3.69 billion, annually. The high 
and low range occurs because of the current uncertainty in the 
estimates of the number of cases of foodborne illness and death 
attributable to the four pathogens. Being without the knowledge to 
predict the effectiveness of the requirements in the rule to reduce 
foodborne illness, the Department has calculated projected health 
benefits for a range of effectiveness levels, where effectiveness 
refers to the percentage of pathogens eliminated at the manufacturing 
stage. The link between effectiveness and health benefits is the 
proportionate reduction assumption which is explained in Section IV. 
Because of the wide range in estimates for the cost of foodborne 
illness, each effectiveness level will have a low and high estimate for 
public health benefits. These estimates of public health benefits are 
shown in Table 2, as the present value of a 20-year benefit stream.
    The analysis assumes that benefits will begin to accrue in year 
five. The five year lag leads to conservative benefit estimates since 
the new HACCP-based inspection program will be fully implemented in 42 
months, and benefits should accrue during those 42 months as well as in 
the 1\1/2\ years that follow. Limiting the benefit estimates to four 
pathogens also leads to conservative cost estimates. To the extent that 
the proportionate reduction estimate may overestimate benefits, these 
other factors provide conservative balance.
    Net benefits exist for every cost and benefit combination 
illustrated in Table 2 except for the case of 10 percent effectiveness 
using the low benefit estimate. If the low benefit estimate is correct, 
the new HACCP-based regulatory program would have to reduce pathogens 
by 14 to 17 percent to cover the projected 20-year industry costs of 
$968 to $1,156 million. For the high benefit estimate net benefits 
begin to occur at an effectiveness level of 4 to 5 percent.
    The costs summarized in Tables 1 and 2 have not been reduced to 
account for firms that already have existing HACCP programs. FSIS does 
not have a good estimate of the number of such firms.

C. Impact on ``Smaller'' Businesses

    The final rule provides regulatory flexibility for smaller firms 
consistent with the Regulatory Flexibility Act. For the slaughter 
facilities, the generic E. coli sampling requirements vary depending on 
the number of birds or animals slaughtered annually. This will 
significantly reduce the microbial

[[Page 38957]]

testing costs for smaller establishments which, under the proposed 
rule, would have been required to test every species or kind they 
slaughter every day on which slaughter of that species or kind occurs. 
Under the final rule, the impact on smaller establishments is mitigated 
by the change to base generic E. coli sampling requirements on annual 
production and by a change to no longer require that every species or 
kind be sampled. The costs to small establishments are also reduced 
because the proposed carcass cooling and antimicrobial near term 
requirements have been eliminated from the final rule and training 
requirements are more flexible. The requirement to sample each variety 
of raw ground product, which caused a heavier burden on small 
establishments, has also been eliminated.
    The regulatory burden on small establishments is eased by the 
provisions which extend the time small establishments have to meet the 
HACCP system requirements. The detailed cost analysis in Section V 
outlines the methodology used in developing cost estimates and varying 
regulatory requirements for the purpose of regulatory flexibility for 
small establishments.

D. Effect on Retail Price

    The preliminary analysis included an estimate that the total four-
year implementation costs represented only $0.0024 per pound of fresh 
meat and poultry. This type of estimate helps put overall cost figures 
into perspective in terms of the potential increase in food prices. A 
large number of smaller processors responded very emotionally to the 
low figure of $0.0024 per pound on the basis that the lack of economies 
of scale in their businesses means their potential unit cost increases 
would be far higher. This ``cost-per-pound'' analysis was not meant to 
imply that the cost impact on all business would be the same. In a 
competitive industry, the impact on overall retail price is, however, 
an important indicator of net societal benefits. The four-year 
implementation costs for the final rule represent $0.0011 to $0.0013 
per pound based on 1993 production of 67.15 billion pounds (66.4 
billion pounds federally inspected and 748 million state inspected) of 
meat and poultry on a carcass weight basis. The annual recurring cost 
of $99.6 to $119.8 million represents $0.0015 to $0.0018 per pound 
based on 1993 production.

E. Impact on International Trade

    The final rule will have an impact on countries and the 
establishments in those countries that export meat and poultry products 
to the United States. The inspection statutes require that imported 
product be produced under an inspection system that is equivalent to 
the U.S. inspection system. The equivalence of a country's system must 
be established by the United States before product can be exported to 
the United States. The notion of equivalence has been clarified under 
the World Trade Organization (WTO) Agreement on Sanitary and 
Phytosanitary measures. Under the WTO, all members have an obligation 
to apply the principle of equivalence on importing countries. 
Equivalence determinations are based on scientific evidence and risk 
assessment methodologies.
    In light of the WTO emphasis on the use of science to determine 
equivalence, a number of countries are moving toward implementation of 
HACCP systems. The preliminary analysis noted that a large portion of 
the eligible exporting establishments are in countries that are 
themselves in the process of implementing HACCP and complying with 
their own country's HACCP requirements may achieve equivalence with the 
requirements of this rule.
    As of January 1, 1995 there were 1,395 establishments in 36 
different countries certified to export meat or poultry products to the 
United States. Canada (599 establishments), Denmark (125 
establishments), Australia (111 establishments) and New Zealand (94 
establishments) accounted for two-thirds of the 1,395 establishments. 
These four countries were the source of 85 percent of the 2.6 billion 
pounds of product imported during 1994. These four countries are 
currently developing HACCP systems for their respective inspection 
programs.
    Half (18) of the 36 countries have fewer than 10 establishments 
approved to export products to the U.S. These 18 countries represent a 
total of 77 establishments, 5 percent of the total. Meeting the 
equivalency requirements may present a problem for some of these 
countries in the near term. Their inspection programs will have to meet 
equivalency requirements for HACCP according to the implementation 
schedule for domestic establishments, i.e., 18 months for large 
establishments, 30 months for small establishments and 42 months for 
very small establishments. This schedule should lessen the burden on 
smaller establishments.
    There are other factors that will affect the burden on foreign 
establishments. As HACCP becomes the international norm, these 
establishments will be required to implement changes to meet the 
requirements of other countries implementing HACCP. Thus, their costs 
may not be solely associated with U.S. requirements. Establishing 
impact is further complicated because the U.S. requirements apply only 
when they are preparing product that is to be exported to the U.S. This 
product may represent only a small portion of total establishment 
production.
    Upon implementation of these regulations, FSIS will review other 
countries' meat and poultry systems to ensure that exporting countries 
have adopted comparable measures, which would entitle them to continue 
exporting product to the United States. As other countries improve 
their regulations by adopting provisions comparable to those contained 
in this rule, it is expected that U.S. exports will similarly be 
affected, i.e., the receiving countries will be closely reviewing 
domestic exporting establishments to assure that they are meeting the 
requirements of the importing country.
    FSIS will continue to carry out its import inspection 
responsibilities with a two-stage approach. The first stage is system 
review, which consists of an evaluation of the laws, policies, and 
administration of the inspection system in each eligible country. This 
overall evaluation will include an assessment of the implementation of 
HACCP supplemented by on-site reviews of individual establishments, 
laboratories, and other facilities within the foreign system. The 
``equivalency'' of foreign requirements will be determined at this 
stage.
    The second level of review involves port-of-entry inspection by 
FSIS inspectors to verify the effectiveness of foreign inspection 
systems. Using statistical sampling plans based on the foreign 
establishment's history and the nature of the product, FSIS will 
continue to give greater scrutiny to shipments posing the highest risk. 
Products that do not meet U.S. requirements, which includes having been 
produced under a HACCP or HACCP-equivalent system, will be refused 
entry. FSIS has concluded that requiring HACCP systems in combination 
with the two-stage inspection approach will better ensure the safety of 
imported meat and poultry products.
    All countries exporting raw products to the U.S. must develop and 
implement performance standards that are equivalent to the pathogen 
reduction performance standards for Salmonella. They must also be able 
to demonstrate that they have systems in place to assure

[[Page 38958]]

compliance with the standards. As with any other type of standard, FSIS 
could choose to test imported product for Salmonella at port-of-entry 
to verify the effectiveness of the foreign inspection system.
    With respect to the specific requirements for sampling generic E. 
coli to validate control of slaughter and sanitary dressing procedures, 
it will be necessary for all foreign countries to demonstrate that they 
have an equivalent procedure to verify that they are controlling their 
slaughter and sanitary dressing processes.
    There were several comments related to trade issues. Most of the 
comments concerning the impact on exports dealt with the proposed 
requirement for antimicrobial treatment of U.S. product. That proposed 
requirement raised particular concerns because the European Union 
member states and Canada restrict the use of certain antimicrobials on 
meat and poultry carcasses. The concerns raised in the comments are no 
longer an issue because the final rule does not require the use of 
antimicrobials. The final rule will affect exports only if a company 
has difficulty meeting the microbial performance criteria without using 
an antimicrobial. One option discussed in the proposed rule was that 
hot water would be considered to be an acceptable antimicrobial 
treatment, and that would be acceptable to Canada and the members of 
the European Union. The public comments also indicated that Trisodium 
Phosphate (TSP) is approved for use in Canada and the United Kingdom 
and is being considered by the European Union, Australia, and New 
Zealand.
    Comments related to imports were concerned about the procedures 
FSIS would use to determine equivalence with the new U.S. requirements. 
As a condition of the NAFTA Treaty and the GATT Treaty, the United 
States has agreed to allow imports from countries that have systems of 
inspection equivalent to that of the United States. FSIS is considering 
alternative methods for determining that a foreign country's system of 
inspection can assure that the establishments within that system are 
using a process control system equivalent to the HACCP-based inspection 
system outlined in the final rule.

F. Impact on Agency Costs

    Implementation of this rule will lead to both one-time nonrecurring 
costs and recurring costs for FSIS. There are three categories of one-
time nonrecurring costs: (1) Training, (2) in-establishment 
demonstration projects, and (3) laboratory renovation. In order to 
implement the rule, FSIS will provide training to in-establishment 
personnel in two segments. The first training segment will cover issues 
related to sanitation standard operating procedures and generic E. coli 
sampling and testing requirements. The estimated costs for this 
activity is $3.6 million in the first year of implementation. The 
second training segment will cover issues related to the implementation 
of HACCP and is estimated the cost $3.6 million spread over the second 
and third year of implementation. FSIS will utilize the train-the-
trainer approach to minimize the costs of these initiatives. FSIS is 
also committed to working with States and industry to sponsor HACCP 
demonstration projects for small businesses. Pursuant to implementation 
of the HACCP rule, microbiological sampling and testing will increase 
dramatically. In the period from 1990 to 1995, FSIS averaged 
approximately 33,000 analyses for microbiology per year. This is 
estimated to increase to 125,000 analyses per year after HACCP 
implementation. In order to accommodate this increase, FSIS will 
renovate its field laboratory facilities to expand their capacity, 
improve ability to test for a broader range of pathogens, and purchase 
new equipment. FSIS estimates that the planned renovation will cost 
$1.5 million.
    By implementing this rule, FSIS will incur recurring costs 
associated with increased microbiological testing and upgraded 
inspector salaries. FSIS estimates that microtesting costs will 
increase approximately $3.0 million annually. Of this amount $2.0 
million is needed for equipment, supplies, and shipping costs to 
conduct Salmonella testing, $0.5 million for microtesting conducted to 
verify HACCP systems, and $0.5 million for personnel necessary to 
handle the increased workload. Under HACCP-based inspection, FSIS 
personnel will be required to assume greater responsbility for more 
complex food inspection tasks. Slaughter inspectors will be required to 
perform health and safety tasks, such as taking microbiological 
samples, and verifying HACCP systems. Processing inspectors' roles will 
take them out of the establishment and put them into retail and market 
place settings to take microbiological samples, and to ensure meat and 
poultry products are handled in a manner to that minimizes the growth 
of pathogenic organisms. FSIS estimates that compensating inspectors 
for assuming more complex food safety tasks will cost $1.6 million per 
year.

G. Impact on State Programs

    Comments stated that FSIS failed to adequately consider the cost of 
the changes to State programs and that FSIS was increasing the resource 
demands for State programs without providing adequate funding. The 
preliminary analysis did not address the impact on State programs. 
However, FSIS recognizes that the 26 States operating their own meat 
and poultry inspection programs will likely have to substantially 
modify their programs after the HACCP/Pathogen Reduction regulation is 
finalized to remain ``at least equal to'' Federal inspection programs 
as required by the FMIA and PPIA. During the regulation's 
implementation period, FSIS will be using the Agency's State-Federal 
Program staff to assist the States in bringing the necessary changes to 
the State inspection programs. Although FSIS has requested some 
additional funds to implement this rule, FSIS has also acknowledged 
that implementation of this rule will require eliminating some tasks, 
conducting other tasks differently and streamlining the organization in 
order to free up resources to fully address the new requirements. FSIS 
believes that the same type of restructuring or reprogramming will take 
place within the State programs. This does guarantee, however, that all 
States with inspection programs will be able to implement the necessary 
program changes without additional funds. FSIS believes, however, that 
with FSIS assistance and with the flexibility provided under the 
``equal to'' provisions, most of the States should be able to modify 
their programs with minimal additional funding. To the extent that 
there are any additional costs, the State inspection programs are 
eligible to receive up to 50 percent Federal matching funds.

H. Consumer Welfare Analysis

    It is likely that at least some of the costs of the new HACCP-based 
regulatory program will be passed on to consumers in the form of higher 
prices. Even if costs are fully reflected in retail prices, the impact 
on consumers and consumption will be small. Retail costs are not 
expected to increase more than 0.02 percent. Retail demand for meat and 
poultry is inelastic. A likely range is -0.25 to -0.75. This suggests 
changes in quantity demanded of less than 0.02 percent. Given that 
annual per capita meat and poultry consumption is about 211 pounds, 
retail weight, the impact on individual consumption will be less than 
\1/10\th of a pound per year. In aggregate, with a high impact

[[Page 38959]]

scenario, consumption would decrease by about 50 million pounds. These 
impacts may be overstated if meat and poultry producers pass some costs 
back to livestock and poultry producers. Improved consumer confidence 
in the safety of meat and poultry could offset price driven decreases 
in consumption.

IV. Analysis of Public Health Benefits

A. Introduction

    This section addresses the methodology used to develop the 
estimates for public health benefits that, for the purpose of this 
final Regulatory Impact Assessment, have been defined as the reduction 
in the cost of foodborne illness attributable to pathogens that 
contaminate meat and poultry products at the manufacturing stage. This 
section is organized around the Agency's responses to the public 
comments related to benefits. The first part of this section addresses 
the general comments related to risk assessment. The Agency has 
responded to these general requirements by providing an overall summary 
of the current state-of-the-art with respect to risk assessment for 
foodborne pathogens. The second part of the discussion (see subsection 
titled ``Analysis of Comments on Public Health Benefits'') addresses 
the more specific comments on the methodology used to estimate benefits 
in the preliminary analysis.
    Several comments suggested that FSIS has not conducted an adequate 
risk assessment and/or should conduct a thorough risk assessment before 
proceeding with the current rulemaking. More focused comments assert 
that the relationship between pathogen reduction at the manufacturing 
stage and foodborne illness reduction is unknown. Those comments 
suggest that establishing that relationship requires a quantitative 
risk assessment, i.e., an estimate of the probability of adverse health 
effects (foodborne illness) given a particular level of a hazard 
(pathogens at manufacturing stage).
    The preliminary analysis and this final RIA recognize that the 
relationship is unknown and acknowledge that there are significant data 
gaps regarding both likelihood and magnitude of illness and numbers of 
foodborne pathogens. These data gaps mean that multiple assumptions 
must be made in order to calculate the probabilities of risk, and FSIS 
is concerned with this tremendous uncertainty. However, the agency is 
developing quantitative assessments and believes that these will become 
the basis on which to make future regulatory decisions. In this 
rulemaking, FSIS estimates of the risk of foodborne disease linked to 
specific pathogens are based upon the best judgement of nationally 
recognized experts in infectious disease, epidemiology, microbiology, 
and veterinary medicine. FSIS is also relying on a qualitative 
estimation of risk as expressed in publications and summary reports 
from the CDC, other public health agencies, and special panels, such as 
the National Advisory Committee on Microbiological Criteria in Foods 
and those established by the NAS. Based on this sizable body of 
information and scientific judgement, FSIS is proceeding to develop 
benefit estimates using the assumption that a reduction in pathogens 
leads to a proportionate reduction in illness and death. The benefits 
analysis could have used a more conservative relationship estimate, 
e.g., a reduction in pathogens leads to a reduction in illness that is 
less than proportional. However, given the current level of knowledge, 
FSIS views the proportional assumption as most appropriate at present.
    The Department has initiatives in place that will begin to relate 
pathogen levels at inspected establishments to incidence of human 
illness and support quantitative risk assessment (see Section IV-D on 
FSIS Data Initiatives). The present paucity of data to support a risk 
model for the major foodborne pathogens causing human disease limits 
the usefulness of quantitative risk assessment in the regulatory arena 
of meat and poultry inspection. It is unlikely that any single 
numerical constant will adequately describe the dose-response 
relationships for all pathogens associated with all of the products 
that FSIS regulates, given the complexity of possible interactions of 
factors associated with the host, the pathogenic strain, the diet, and 
the environment (CAST, 1994).
    The Federal Crop Insurance Reform and Department of Agriculture 
Reorganization Act of 1994 (P.L. 103-354) now requires that for each 
proposed major regulation (i.e. economic effects of at least $100 
million a year and effects on human health, safety, or the environment) 
the Department publish an analysis of the risks addressed by the 
regulation. While this statute does not apply to this final rule, FSIS 
is providing a qualitative estimation of risk (Tables 4 and 5) and a 
recommendation to manage risk using HACCP in meat and poultry 
inspection programs. Concurrently, scientists from FSIS and USDA's 
Agricultural Research Service (ARS), Economic Research Service (ERS), 
and modelers from academia and industry continue to develop risk models 
which blend failure analysis, predictive microbiology, and other models 
into the framework described by the NAS (NRC, 1983). FSIS believes this 
approach is flexible and responsive to new data necessary to fully 
document risks of foodborne diseases.

B. FSIS Risk Assessment

    Following the publication of the 1985 National Academy of Sciences 
(NAS) study on the scientific basis for meat and poultry inspection, 
FSIS requested that the National Research Council of NAS conduct a 
follow-up study that included the objective of developing a risk 
assessment model for the poultry production system. The subsequent 
report, ``Poultry Inspection: The Basis for a Risk-Assessment 
Approach'' was published by the National Academy Press in 1987. The 
1987 study concluded that the present system of inspection provides 
little opportunity to detect or control the most significant health 
risks presented by microbial agents that are pathogenic to humans. The 
study also concluded that current databases can serve as the basis for 
a comprehensive, quantitative risk assessment only for certain well-
characterized chemical residues.
    The committee conducting the study also concluded that their report 
did constitute a qualitative risk assessment that could be useful for 
many purposes, including the evaluation of inspection strategies. That 
assessment found: ``There is evidence linking disease in humans to the 
presence of pathogens on chickens. For example, epidemiological studies 
indicate that approximately 48% of Campylobacter infections are 
attributable to chicken. Data also suggest that chicken is probably an 
important source of salmonellosis in the United States.'' Based on 
these and other findings, the committee recommended that FSIS ``modify 
the existing system so that it more directly addresses public health 
concerns.'' FSIS believes that the implementation of HACCP programs at 
slaughter for meat and poultry is such a ``modification'' of the food 
safety system which will address human health hazards, particularly 
foodborne diseases.

C. Risk Assessment Framework

    The National Research Council (1983) presented a framework for risk 
assessment that has become a standard paradigm to organize risk 
assessments for chemical and microbial hazards. The framework, 
consisting of hazard identification, dose-response assessment, exposure 
assessment, and risk characterization, is flexible and can accommodate 
many different modeling strategies. The major distinction

[[Page 38960]]

between foodborne microbial risk assessments and chemical risk 
assessments may be the additional uncertainties of microbial growth and 
survival in food prior to consumption. Survival of pathogens present in 
a raw food and after cooking can be modeled using predictive 
microbiology methods. These models can also address the growth of 
pathogens with time and temperature abuse of raw and cooked foods.
    One of the first U.S. publications on the application of predictive 
microbiology to microbial risk assessment (Buchanan & Whiting, 1996) 
included estimations of risk of salmonellosis for several ``what-if 
scenarios'' as examples of potential time and temperature abuses of 
partially cooked food. The predictive microbiology model was linked to 
a published dose-response model for salmonellosis (Haas, 1983) to 
calculate a risk estimate. The dose-response model was developed by 
empirically fitting data from human feeding studies conducted at high-
dose challenges with a number of pathogenic strains of Salmonella to 
the ``beta poisson'' model (Haas, 1983). The authors generated risk 
estimates for selected cooking and abuse scenarios, but recognized that 
the risk of illness is zero when the pathogen is not present in the 
sample even with unsafe food handling. HACCP programs at slaughter are 
expected to affect pathogen presence and levels before potential time 
and temperature abuses can occur. Therefore, changes at slaughter, in 
the duration of cooking, and final storage conditions of the food exert 
a tremendous impact upon the model outcomes.
    An unpublished draft risk model is in development as a research 
endeavor by Agriculture and Agri-Food Canada and Health Canada. A 
variety of modeling approaches were organized within the 1983 NRC 
framework to estimate risk of human illness from E. coli 0157:H7 in 
ground beef. The draft risk model includes many stochastic variables to 
account for the variability and uncertainty associated with the inputs 
and assumptions of the model. The authors are developing the model to 
identify current limitations to the construction of quantitative models 
which accurately describe the risk of foodborne disease along the farm 
to fork continuum.
    These recent quantitative risk assessment efforts are an 
encouraging beginning and serve to illustrate the tremendous 
uncertainties created by insufficient data describing processes 
throughout the farm to table continuum that contribute to risk. 
Additional uncertainties surround assumptions based on epidemiologic 
data for human illness. For example, recent data in the U.S. indicates 
a growing number of outbreaks of E. coli 0157:H7 disease linked to 
sources other than ground beef. The ecology of the organism on the 
farm, in the bovine gastrointestinal tract, and in irrigation, 
recreational, and drinking waters is largely unknown. Additionally, the 
primary sources of E. coli 0157:H7 causing sporadic disease may remain 
undercooked hamburger and may differ from vehicles causing outbreaks, 
as has been documented for Campylobacter (CDC, 1988). Outbreaks of 
campylobacteriosis have been caused primarily by unpasteurized milk and 
contaminated water, yet the overwhelming majority of infections are 
sporadic and have been linked to undercooked chicken. Control 
strategies to reduce both outbreak and sporadic case numbers for both 
of these pathogens may require greater understanding of vehicles of 
disease and more information than is currently available.
    FSIS concludes that risk models for foodborne illnesses are 
necessarily based largely on assumptions because scientific data 
describing key foodborne disease processes have not been developed. The 
models are extremely useful to identify basic research needs that might 
reduce the uncertainty associated with the inputs and assumptions of 
the models. The agency is proposing initiatives to generate data which 
may reduce uncertainties associated with modeling the risk of foodborne 
diseases. However, application of microbial risk assessment models to 
regulatory decision-making appears premature at this time. The 
following is a summary of the availability and limitations of data 
supporting risk assessment for foodborne pathogens:
1. Hazard Identification
    The Agency selected from the pathogens listed in Tables 4 and 5 the 
three most common enteric pathogens of animal origin: Campylobacter 
jejuni/coli, E. coli 0157:H7, Salmonella and one environmental pathogen 
Listeria monocytogenes for consideration in risk assessment. FSIS 
believes that these four pathogens may contaminate meat and poultry 
food vehicles at slaughter and can be reduced through improved process 
control in the manufacturing sector. Available data on estimated human 
disease incidence are summarized in Table 4. Data on human disease 
attributable to proven as well as epidemiologically linked pathogens 
and food vehicles are presented in Table 5. Additional and more precise 
information for this section regarding estimated national disease 
incidence and disease severity and duration is expected on these 
pathogens from the sentinel site surveillance initiative.
2. Exposure Assessment
    Rarely can actual exposure to a specific strain of foodborne 
pathogen be quantified with certainty in foodborne disease outbreaks. 
Microbes in food are known to be non-homogeneously distributed, 
imposing additional uncertainty due to sampling error upon the 
analytical variability of the methods for detection and quantification 
of microbes in foods. The outbreak strain may or may not be detected in 
the feces of diarrheal cases or in leftovers or companion samples from 
suspected lots. The levels detected in leftovers or companion samples 
from the same lot of food may or may not be representative of the 
serving that was prepared and consumed since the microbial numbers vary 
with time and temperature conditions and the initial microbial 
populations. The amount of the serving consumed may not be known.
    The FSIS baseline studies provide data on occurrence of pathogens 
(likelihood) and levels (magnitude) in uncooked meat and poultry 
products at slaughter and raw ground processing. Data for likelihood 
and magnitude of pathogens in the distribution, preparation, and 
consumption phases of the farm-to-fork continuum of food production are 
sparse. Predictive microbiology models may be the most cost-effective 
method to deduce possible exposure scenarios in meat and poultry beyond 
the slaughter phase that may result in foodborne illness. The 
likelihood that the selected scenarios of improper cooking and abuse 
actually occur among U.S. consumers may not be measurable, but the 
scenarios may be useful in modification of behaviors that pose 
increased risk to consumers.
3. Dose-Response Assessment
    The relationship between the dose of a pathogen and response in the 
host, when known, can vary greatly for foodborne pathogens. Human 
feeding studies with foodborne pathogens were largely conducted several 
decades ago with small numbers of healthy adult males. One study 
reported both ill and asymptomatic volunteers who had consumed up to 
1,000,000,000 pathogenic Salmonella. Outbreak data for other Salmonella 
serotypes in food vehicles suggest a range of infective doses from one 
cell to 1,000,000,000,000 cells (Blaser & Newman, 1982). Fatty food 
vehicles, including some meat and

[[Page 38961]]

poultry products, are thought to protect enteropathogens from stomach 
acids and digestive enzymes that might otherwise reduce the dose to the 
intestinal tract and reduce the likelihood of disease. The effects of 
competition of the pathogen with the large indigenous microbial 
populations in food (ICMSF, 1980) and in the human gastrointestinal 
tract (Rolfe, 1991) may reduce the likelihood and/or the severity of 
foodborne disease.
    Even carefully controlled volunteer feeding experiments at doses up 
to one billion organisms per volunteer have shown variability in the 
infectious dose of one pathogen for individuals within a group of 
seemingly healthy, young adults. Extrapolation of empirical models of 
effects at high doses to low doses typical of properly handled food may 
or may not be appropriate. The dose-response curve for healthy adult 
males may not be useful in estimating dose-response relationships for 
the general population or sensitive sub-populations. The data available 
from human feeding studies were generated from very few species and 
strains of bacterial pathogens, excluding E. coli 0157:H7. Dose-
response modeling is crucial to microbial and chemical risk 
assessments. FSIS believes that application of dose-response models in 
food safety regulation requires careful examination of the validity of 
the assumptions and inputs of the model and of the plausibility of the 
model as a descriptor of foodborne disease processes.
4. Risk Characterization
    The integration of exposure and dose-response models is expected in 
risk characterization, along with sensitivity and uncertainty analyses 
(Burmaster & Anderson, 1995) for the risk model. Perhaps of greater 
significance than the numerical estimate of risk is the uncertainty 
associated with the estimate. A fully developed risk characterization 
would include risk estimates and sensitivity/uncertainty analyses for 
alternative models and assumptions. FSIS is collaborating with 
scientists in academia, the Agricultural Research Service, the Animal & 
Plant Health Inspection Service, the Economic Research Service, and the 
Office of Risk Assessment and Cost Benefit Analysis to develop and 
validate a risk assessment model for a single pathogen in a single meat 
product. This model may be modified for other specific pathogens of 
concern. The expectation of a generic model for all foodborne disease 
agents in all products does not appear promising based on differences 
in pathogenesis of bacterial species and strains and in human 
sensitivity and pathology.
    FSIS continues to evaluate new information on foodborne pathogens 
and on risk assessment methods and tools in accordance with the FSIS 
public health mission. The NAS Report, the CAST Report and the 1995 
Conference recognize HACCP as a system to reduce the likelihood of 
foodborne illness. The CAST Task Force also concluded that ``the 
efficacy of a HACCP system depends on the rigor and consistency with 
which it is designed and implemented and the use of (a) critical 
control point(s) that will control pathogens.''

D. FSIS Data Initiatives

     The 1994 report, ``Foodborne Pathogens: Risks and Consequences, 
CAST Task Force Report No. 122, September 1994'' concluded that ``a 
comprehensive system of assessing the risks of human illness from 
microbial pathogens in the food supply has yet to be devised.'' They 
cited the limitations of the current food safety information database 
and the difficulty in accumulating dose response and minimum infective 
dose data. A recent multidisciplinary conference, ``Tracking Foodborne 
Pathogens from Farm-to-Table, Data Needs to Evaluate Control Options'', 
carefully reviewed current databases and confirmed limitations outlined 
in the CAST Task Force report.
    FSIS has established initiatives to improve the quality and 
quantity of data in two major areas. First, FSIS is working with the 
Food and Drug Administration (FDA) and the Centers for Disease Control 
and Prevention (CDC) to establish an active sentinel site surveillance 
system for the major causes of foodborne illness. This project is 
designed to accumulate data on the incidence of foodborne illness by 
pathogen and by food.
    Second, the Agency has been developing baseline data for pathogen 
levels on major food animal species at the time of slaughter. The 
baseline data will allow the Agency to detect changes in the overall 
nation-wide pathogen levels. The National Baseline program was 
initiated in 1992 to provide information on the type and level of 
microbiological contamination on raw products under Federal inspection. 
Each sample collected is analyzed for nine microorganisms or groups of 
organisms. Microbiological baseline data are now available for steers 
and heifers, cows and bulls, and broiler chickens.
    If sufficient data on both pathogen levels and foodborne disease 
epidemiology result from current and future initiatives, FSIS should be 
able to develop models showing how these two variables are related for 
different pathogens. These models should then permit/facilitate a 
quantitative estimate of risk. Such data are essential for FSIS to 
evaluate the effect of control measures on both pathogens levels and on 
foodborne illness.

E. ARS Food Safety Research Program

    The Agricultural Research Service (ARS) administers a food safety 
research program that is currently funded at approximately $45 million 
per year. This program addresses problems in four different areas; 
pathogen reduction, mycotoxins, residues, and natural toxins. The 
reduction of microbial pathogens in food products of animal origin is 
the most pressing food safety problem today. Consequently, the pathogen 
reduction component is the largest of the four areas and is currently 
funded at $18.2 million annually. The ARS research in pathogen 
reduction addresses both preharvest and animal production, and post 
harvest problem areas, with approximately equal funding for each.
    Ongoing ARS research will help FSIS improve its capability for 
performing quantitative risk assessment in the area of foodborne 
pathogens or improve the ability to predict the effectiveness of new 
pathogen reduction technologies. Ongoing projects include the modeling 
of bacterial growth or thermal death times which will help set 
standards for meat and poultry products. Ongoing projects will also 
provide new laboratory screening or confirmatory methods. Other 
projects provide and/or evaluate technology and management methods 
which can help producers achieve lower contamination levels in animals 
presented for slaughter, such as vaccines or competitive bacterial 
cultures to prevent pathogens in live animals. There are also 
technology and management methods for use in slaughter and processing 
establishments, such as, organic acids for use in carcass sanitation, 
improvements to the feather picking operation for poultry, washing of 
trailers to reduce microbiological contamination, and establishment of 
guidelines on the microbiological safety of recycling cooling solutions 
for ready-to-cook meat and poultry products. In many cases the research 
may provide the scientific basis for developing and improving 
technology, for example, the nature of bacterial attachment to various 
meat surfaces.
    FSIS can and does forward very specific research requests to ARS. 
In preparation for this final rule, FSIS requested that ARS compare the 
results

[[Page 38962]]

from different microbial sample collection techniques, sponging versus 
excision at one versus three carcass sites. These studies are currently 
being conducted on both cow/bull and market hog carcasses. There are 
other specific ARS projects that will help provide the scientific basis 
for HACCP through risk assessment, predictive microbiology, and 
pathogen reduction interventions for several different bacterial 
pathogens which must be controlled to assure the safety of meat and 
poultry.
    These projects include: (1) Development of models to predict the 
growth rates, survival times, and thermal death rates for microbial 
pathogens potentially present in foods, including meat and meat 
products. (Microbiological modeling is time consuming and expensive 
because it requires that the data be quantified, that is, that numbers 
of bacteria are obtained, rather just the knowledge of the presence or 
absence of a pathogen under the conditions of the test.) The 
microorganisms being studied include E. coli O157:H7, Listeria 
monocytogenes, and Salmonella. These models are written into personal 
computer software that gives FSIS a readily useable tool to help 
evaluate proposed meat processes and assess out-of-process events. 
Refining predictive models has the goal of linking an entire process 
from raw ingredients to distribution of finished product. A specific 
project is to model the survival of E. coli O157:H7 during the 
manufacture of uncooked, fermented meat products. Using the information 
obtained, ARS will closely collaborate with other USDA agencies to 
develop strategies for risk reduction using the various processing 
techniques, and to create risk assessment models.
    (2) Modeling studies to predict the thermal inactivation of spore-
forming and non-spore-forming bacterial pathogens of both cooked and 
ready-to-eat products. These studies will be extended to the cooling of 
these products to ensure that there is no potential for growth of 
Clostridium botulinum and C. perfringens.
    (3) Determination of the long-term effects (21 days of storage at 
refrigerated temperatures) of organic acid treatment of red meat on 
some key pathogens (E. coli O157:H7, Listeria, and Clostridium), as 
well as on spoilage bacteria (mesophilic aerobes, lactic acid bacteria, 
and pseudomonads).
    (4) Delineation of the parameters affecting the antibacterial 
activity of organic acids. These include tissue type (pre-rigor, post-
rigor, frozen post rigor), inoculum type (pure culture or inoculated 
feces), inoculum level and the temperature of spray wash at meat 
surface. These results should clarify inconsistent reports on 
antibacterial activity of organic acids and also define optimum 
conditions to maximize the antibacterial activity of organic acids.
    (5) The correlation of the Campylobacter levels in broilers from 
the chill tank with their Campylobacter levels during production.

F. Analysis of Comments on Public Health Benefits

    There were many comments on the methodology used to estimate public 
health benefits in the preliminary analysis. This methodology used a 
series of estimates or assumptions based on incomplete data related to 
the six following areas:
     Incidence of foodborne illness
     Cost of foodborne illness
     Percentage of foodborne illness and cost of foodborne 
illness attributable to meat and poultry products
     Pathogens addressed by the rule
     Effectiveness of rule in reducing pathogens
     Estimated reduction in cost of foodborne illness related 
to reduction of pathogens
    To facilitate discussion of the issues raised in comments, the 
issues are addressed organized by these six areas.
1. Incidence of Foodborne Illness
    Table 4 presents the most recent estimates on the incidence of 
illness and death for selected pathogens along with the latest 
estimates on the percentage of illness and death which is foodborne. As 
discussed in the preliminary RIA, Table 4 includes the ``best 
estimates'' when precise data are not available. Many of these 
estimates are based on the landmark CDC study by Bennett, Holmberg, 
Rogers, and Solomon, published in 1987, which used CDC surveillance and 
outbreak data, published reports, and expert opinion to estimate the 
overall incidence and case- fatality ratio for all infectious and 
parasitic diseases. Estimates on the foodborne percentage of illness 
and death for bacteria in Table 4 are all based on CDC data. The 
resulting estimates for the number of foodborne cases and deaths are 
presented in the second and third columns of Table 5.
    The benefits for the preliminary analysis and this final RIA are 
calculated for the three most common enteric pathogens of animal 
origin: Campylobacter jejuni/coli, E. coli O157:H7, Salmonella and one 
environmental pathogen Listeria monocytogenes. FSIS believes that these 
four pathogens can be reduced through improved process control in the 
manufacturing sector.
    Although Clostridium perfringens and Staphylococcus aureus also 
cause a significant number of foodborne illnesses, they are not 
included in the benefits analysis because it is not clear that the 
HACCP-based regulatory program, which focuses on federally inspected 
processing, will significantly affect the incidence of disease caused 
by these organisms. Staphylococcus aureus usually enters the food chain 
through food handlers in restaurants and other commercial kitchens. 
Although C. perfringens may enter the food chain through the slaughter 
process, it is so ubiquitous in the environment that FSIS will not 
assume that controls at slaughter will be effective against this 
pathogen.
    One commenter questioned why the Agency has not addressed the 
public health problem of toxoplasmosis given the Table 5 estimate of 
$2.7 billion in annual costs. FSIS believes that while process control 
may help decrease the spread of cysts during boning and cutting 
operations, most of the Toxoplasma gondi cysts are internal to 
infective muscle tissues and are not addressable by process control. 
Therefore, FSIS is making the more conservative assumption to exclude 
this pathogen in the benefits estimate of disease averted.
    Many comments suggested that the large range in the illness 
incidence estimates demonstrates that there are insufficient data on 
which to base a new regulatory program. Historically, the lack of 
quantitative data on benefits and specific health risks have meant that 
health and safety regulations have required decisionmaking under 
uncertainty and have required the decisionmaker to balance the need to 
act with the need for additional or improved data. Compared to such 
issues as whether a chemical is a potential human carcinogen or whether 
low levels of air pollutants cause adverse health effects, the health 
effects of enteric pathogens are relatively well documented. If the 
pathogens enter the food supply, they do, under certain conditions, 
cause foodborne illness. If their presence can be prevented, no amount 
of temperature abuse, mishandling or undercooking can lead to foodborne 
illness.
    The Agency believes that the existing estimates on foodborne 
illness are adequate to conclude that a substantial and intolerable 
public health problem exists. Furthermore, existing estimates are 
appropriate for developing estimates on the cost of foodborne illness 
attributable to meat and poultry. The

[[Page 38963]]

Agency notes that similar estimates on the incidence of foodborne 
illness have been published by scientists from ERS in peer-reviewed 
journal articles (see footnotes to Table 5) and by the 1994 CAST Task 
Force.
    The above statement that Table 4 includes the most recent estimates 
of the incidence of illness and death requires further explanation in 
the case of Listeria monocytogenes. The estimates of 1,795-1,860 cases 
of listeriosis and 445-510 deaths are the ones used in the latest cost 
of illness study conducted by ERS. ERS is in the process of publishing 
a comprehensive documentation for the estimates of cost of illness for 
1993. In their draft document they acknowledge that the estimate for 
listeriosis cases originates from an extrapolation to the U.S. 
population of incidence data from a CDC-conducted surveillance study of 
six geographic regions in 1986 and 1987 (Gellin et al. 1987). They also 
note that (Tappero et al. 1995) found that the incidence of listeriosis 
has decreased since the 1960's and that projections from the 
surveillance data suggest that there were 1,092 listeriosis cases and 
248 deaths in 1993. ERS did not modify their cost of illness estimates 
because Tappero et al., was published after their analysis was 
concluded.
    FSIS considered modifying the cost of illness estimates for this 
final analysis but decided to use the estimates in Tables 4 and 5 
because (1) They are the figures that will appear in the upcoming ERS 
publication and, (2) updating the listeriosis estimates would have 
minimal impact on the overall cost of illness estimates. Considering 
the overall range and uncertainties involved in the cost of illness 
estimates, the change in listeriosis estimates has negligible impact on 
the regulatory analysis information conveyed through the potential 
benefits estimate.
    The Agency also recognizes that in using the 1993 estimates for 
incidence of foodborne illness, the benefits analysis has not accounted 
for possible reductions in foodborne illness attributable to the rule 
that mandated safe handling statements on labeling of raw meat and 
poultry products. The rule mandating safe handling instructions became 
effective on May 27, 1994. Thus, it can be argued that the incidence of 
foodborne illness for 1994 through the present should reflect the 
effectiveness of the 1994 labeling requirement in reducing the 
incidence of illness.
    FSIS is not aware of any quantitative evaluation of the 
effectiveness of safe handling labeling. Two recent surveys indicate a 
high level of awareness, but these surveys do not contain findings that 
can be translated into changes in consumer behavior. A recent 
Associated Press poll found that 9 in 10 Americans say they follow the 
safe-handling instructions. This poll, conducted in April 1996, 
included 1,019 randomly selected adults. This was a telephone survey 
conducted by ICR Survey Research Group. A November 1995 survey 
conducted by Wegman Food Markets in Buffalo, Rochester, and Syracuse 
found that 67.9 percent of respondents indicated they had read the safe 
handling information. The Wegman's survey found that most household 
meat preparers rely on color of meat or clarity of juices rather than 
temperature to determine when meat has been cooked thoroughly.
    In this analysis, FSIS has not attempted to adjust the 1993 
baseline to account for safe handling labeling. The potential effect of 
the 1994 regulation is one of many factors that could be affecting the 
current incidence or cost of illness. A May 1996 GAO study on foodborne 
illness notes that food safety and public health officials believe that 
the risk of foodborne illness is increasing. If they are correct, the 
1994 labeling rule may be slowing the growth rather than reducing the 
absolute level.
    There are many other factors that could have been incorporated into 
the baseline for the analysis such as population growth and increases 
in the cost of medical care. FSIS believes that attempts to adjust the 
cost of illness baseline to account for factors such as inflation, 
possible increases in foodborne illness due to behavior change or 
population increases, and possible decreases due to inventions such as 
safe handling labels are more likely to be misleading than informative 
given the level of uncertainly and wide range in existing estimates.
2. Cost of Foodborne Illness
    The fourth column of Table 5 shows that the 1993 estimated cost of 
foodborne illness by pathogen or parasite was between $5.6 and $9.4 
billion. These cost of illness estimates have been developed by ERS in 
conjunction with CDC over the past 15 years. As indicated in footnotes 
to Table 5, the results of that work have been frequently published in 
peer-reviewed journals.
    There were only a few public comments on the proposed rule which 
addressed the methodology used for estimating the cost of foodborne 
illness. Some comments argued that the public health benefit estimates 
are low because of the low value-of-life factor used in the estimates 
for the cost of foodborne illness.
    ERS intentionally used a conservative method to estimate the value 
of a statistical life (VOSL) acknowledging the controversy over valuing 
lives. ERS used Landefeld and Seskin's VOSL estimates and recognizes 
that the cost of illness estimates would be substantially higher if 
they used alternative methods. For example, Viscusi (1993) summarized 
the results of 24 principal labor market studies and found that the 
majority of the VOSL estimates lie between $3 million and $7 million 
per life. A survey of the wage-risk premium literature on the 
willingness to pay to prevent death concluded that reasonably 
consistent estimates of the value of a statistical life range from $1.6 
million to $6.5 million dollars (1986 dollars) (Fisher et al. 1989). 
Updated to 1993 dollars using the change in average weekly earnings, 
Viscusi's range becomes $3.2 million to $7.6 million per VOSL and 
Fisher's range becomes $2.0 million to $10.4 million dollars for each 
statistical-life lost. Viscusi and the Fisher estimates are greater 
than the highest Landefeld-Seskin (LS) VOSL estimate of $1,584,605 in 
1993 dollars (estimate for a 22 year old).

                                                 Table 4.--Sources of Data for Selected Pathogens, 1993                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Estimated                                                                                   
             Pathogen                Estimated number of    number of       Source(s) for case and death       Percent                Source            
                                            cases            deaths                   estimates               foodborne                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:                                                                                                                                               
    Campylobacter jejuni or coli..   2,500,000            200-730       Tauxe...............................   55-70     Tauxe et al.                   
    Clostridium perfringens.......      10,000               100        Bennett et al.......................     100     Bennett et al.                 
    Escherichia coli O157:H7......  10,000-20,000         200-500       AGA Conference......................      80     AGA Conf./CDC.                 
    Listeria monocytogenes........  1,795-1,860           445-510       Roberts and Pinner..................   85-95     Schuchat.                      

[[Page 38964]]

                                                                                                                                                        
    Salmonella....................  800,000-4,000,000     800-4,000     Helmick et al./Bennett et al.          87-96     Bennett et al./Tauxe & Blake.  
    Staphylococcus aureus.........   8,900,000             7,120        Bennett et al.......................      17     Bennett et al                  
Parasite:                                                                                                                                               
    Toxoplasma gondii.............       4,111                82        Roberts et al.......................      50     Roberts et al.                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources: American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July 11-13, 1994. Bennett, J.V., S.D.        
  Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden  
  of Unnecessary Illness.  Oxford University Press, New York. Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious
  Diarrheas.'' In: Everheart, JE, ed. Digestive Diseases in the United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94-1447, pp.  
  85-123, Wash, DC: USGPO.                                                                                                                              
Roberts, T., K.D. Murrell, and S. Marks. 1994. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423.
                                                                                                                                                        
Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, September 29, 1994.        
Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins, 
  ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9-19. Tauxe, R.V. and P.A. Blake, 1992. ``Salmonellosis'' Chap. 12.
  In: Public Health & Preventative Medicine, 13th ed. (Eds: Last JM: Wallace RB; Barrett-Conner E) Appleton & Lange, Norwalk, Connecticut, 266-268.     
Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth. 1988. ``Campylobacter Isolates in the United States, 1982-1986,'' Morbidity and         
  Mortality Weekly Report, vol 31, no. SS-2: pages 1-14.                                                                                                



                            Table 5.--Medical Costs and Productivity Losses Estimated for Selected Foodborne Pathogens, 1993                            
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Foodborne illness                   Percent      Meat/poultry related        Total 
                                                              ------------------------------  Foodborne    from  ------------------------------  costs *
                           Pathogen                                                            * costs    meat/                                   meat/ 
                                                                 Est. No. of     Est. No.      (bil $)   poultry    Est. No. of     Est. No.     poultry
                                                                    cases         deaths                   (%)         cases         deaths      (bil $)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:                                                                                                                                               
    Campylobacter jejuni or coli.............................  1,375,000-1,75                                                                           
                                                                        0,000  110-511       0.6-1.0       75     1,031,250-1,31                        
                                                                                                                           2,500  83-383        0.5-0.8 
    Clostridium perfringens **...............................          10,000     100          0.1         50              5,000      50         0.1    
    Escherichia coli 0157:H7.................................    8,000-16,000  160-400       0.2-0.6       75       6,000-12,000  120-300       0.2-0.5 
    Listeria monocytogenes...................................     1,526-1,767  378-485       0.2-0.3       50            763-884  189-243       0.1-0.2 
    Salmonella...............................................  696,000-3,840,                                                                           
                                                                          000  696-3,840     0.6-3.5     50-75    348,000-2,880,                        
                                                                                                                             000  348-2,880     0.3-2.6 
    Staphylococcus aureus **.................................       1,513,000   1,210          1.2         50            756,500     605         0.6    
                                                              ------------------------------------------------------------------------------------------
        Subtotal.............................................  3,603,526-7,13                                                                           
                                                                        0,767  2,654-6,546   2.9-6.7      N/A     2,147,513-4,96                        
                                                                                                                           6,884  1,395-4,461   1.8-4.8 
                                                              ------------------------------------------------------------------------------------------
Parasite:                                                                                                                                               
    Toxoplasma gondii........................................           2,056      41          2.7        100              2,056      41         2.7    
                                                              ------------------------------------------------------------------------------------------
        Total................................................  3,605,582-7,13                                                                           
                                                                        2,823  2,695-6,587   5.6-9.4      N/A     2,149,569-4,96                        
                                                                                                                           8,940  1,436-4,502   4.5-7.5 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: ERS, 1993                                                                                                                                       
* Column rounded to one decimal place.                                                                                                                  
** Roberts' rough approximation of costs in ``Human Illness Costs of Foodborne Bacteria'', Amer. J. of Agricultural Economics, vol. 71, no. 2 (May 1989)
  pp. 468-474 were updated to 1993 dollars using the Consumer Price Index (all items, annual average). Cost estimates for other pathogens are more      
  detailed, see the following for a discussion of the methodology:                                                                                      
listeriosis--Roberts, Tanya and Robert Pinner, ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J.     
  Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137-149,                                                
E. coli O157:H7--Roberts, T. and Marks, S., ``E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease,'' FoodReview, USDA/ERS, Sept-Dec 1993, 
  pp. 51-59.                                                                                                                                            
salmonellosis--Roberts, Tanya, ``Salmonellosis Control: Estimated Economic Costs,'' Poultry Science. Vol. 67 (June 1988) pp. 936-943,                   
campylobacteriosis--Morrison, Rosanna Mentzer, Tanya Roberts, and Lawrence Witucki, ``Irradiation of U.S. Poultry--Benefits, Costs, and Export          
  Potential, FoodReview, Vol. 15, No. 3, October-December 1992, pp. 16-21, congenital toxoplasmosis--Roberts, T., K.D. Murrell, and S. Marks. 1944.     
  ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423; and Roberts, Tanya and J.K. Frenkel,        
  ``Estimating Income Losses and Other Preventable Costs Caused by Congenital Toxoplasmosis in People in the United States,'' J. of the Amer. Veterinary
  Medical Assoc., vol. 196, no. 2 (January 15, 1990) pages 249-256.                                                                                     
N/A indicates item is not-applicable.                                                                                                                   

    ERS is currently working on a sensitivity analysis for their cost 
of illness estimates for foodborne illness. The sensitivity analysis 
replaces the LS VOSL estimates with estimates found in the literature 
on wage-risk studies. Preliminary findings show that the estimates of 
the total cost of foodborne illness will increase greatly when these 
higher VOSL estimates are used.
    FSIS considers that the existing conservative estimates are 
appropriate considering the controversy and uncertainty. The 
conservative estimates are more than sufficient to justify the

[[Page 38965]]

final rule implementing a new HACCP-based regulatory program for meat 
and poultry. This final RIA uses the cost of illness estimates shown in 
Table 5.
    Another comment stated that the cost of illness estimates are low 
because they do not account for increases in productivity. In response, 
the Agency notes that ERS used Landefeld and Seskin's estimates for the 
value of a statistical life, and those estimates do include an 
estimated 1% annual increase in productivity.
    One commenter suggested that a methodology based on earning power 
may overestimate the value of life where many deaths from foodborne 
illness are the very elderly, the immunocompromised and the terminally 
ill. This commenter also noted that while all deaths are tragic, from a 
strictly economic standpoint many of these tragic cases have little or 
no productivity left and in fact are utilizing resources at the rate of 
$3,000 to $12,000 or more dollars per month of maintenance.
    The cost of illness methodology used by ERS does account for the 
fact that older individuals have lower remaining earning power than 
younger individuals. This difference was taken into account when 
estimating the costs of lost productivity for salmonellosis patients. 
Different Landefeld and Seskin estimates of the values of statistical 
life were used for the different age categories. The methodology used 
U.S. death certificate data to estimate that the average age for 
patients who die from salmonellosis is over 65 years. The concept of a 
statistical value of life accounts for the fact that older individuals 
may continue to work or be retired or be patients under long term 
health care.
3. Percentage of Foodborne Illness and Cost of Foodborne Illness 
Attributable to Meat and Poultry
    The fifth column of Table 5 includes estimates on the percentage of 
foodborne illness attributable to meat and poultry products. A separate 
estimate has been developed for each pathogen. These estimates are 
based on outbreak data reported under the CDC Foodborne Disease 
Outbreak Surveillance System and on data from community-based and other 
epidemiologic studies. Major data sources are cited in the preamble to 
the final rule. An assumption is made in this analysis that the source 
of foodborne pathogens, i.e., meat and poultry versus dairy products, 
seafood, vegetable, etc., has no effect on the cost of illness. The 
Department is not aware of any data indicating that the severity of 
foodborne illness cases varies by source of pathogens.
    Comments noted that the Department had increased the percentage of 
foodborne illness attributable to meat and poultry from the earlier 
rulemaking for safe handling labels. One commenter stated that the 
Department has not revealed any new information which would support 
such an increase.
    At this time, data on incidence of foodborne illnesses and the 
percentage of cases attributable to different food items are limited. 
Estimates by pathogen have been made by experts at CDC and USDA, based 
on a variety of studies. However, these are, indeed, estimates: FSIS 
does not have exact numbers. The estimates in the 1993 Federal Register 
document were relatively crude, assuming that 100% of Campylobacter and 
E. coli O157:H7 cases, 96% of Salmonella cases, and 85% of Listeria 
cases were foodborne, and that, for all bacterial pathogens, a flat 50% 
of foodborne cases were attributable to meat and poultry. The 1995 
document looked at the numbers in a somewhat more sophisticated way, 
evaluating each pathogen individually and, where appropriate, giving 
ranges for, first, percentage of cases which were foodborne, and, 
secondly, percentage of cases which were attributable to meat and 
poultry. Nonetheless, when all of the various percentages are 
multiplied out, estimates of total cases attributable to meat and 
poultry were remarkably similar, as shown below in Table 6.

                   Table 6.--Percentage of Foodborne Illness Attributable to Meat and Poultry                   
----------------------------------------------------------------------------------------------------------------
                                               Percentage   Percentage                                          
                                                of total     of total                                           
                                                 cases         cases                                            
                                               attributed   attributed    Estimated total      Estimated total  
                  Pathogen                    to meat and   to meat and     cases, 1993          cases, 1995    
                                               poultry a     poultry,                                           
                                                  1993         1995                                             
                                               (percent)     (percent)                                          
----------------------------------------------------------------------------------------------------------------
Campylobacter...............................           50      41-53      1,050,000         1,031,250-1,312,500 
Salmonella..................................           48      43-72        921,600         348,000-2,880,000   
E. coli O157:H7.............................           50         60     3,834-10,22        46,000-12,000       
Listeria....................................           43      43-48        649-672           763-884           
----------------------------------------------------------------------------------------------------------------
a Reflects percentage of foodborne multiplied by percentage attributable to meat and poultry.                   

    Most other comments related to the estimates on the percentage of 
foodborne illness attributable to poultry. Comments questioned the high 
incidence of poultry-related foodborne illness when even, as a 
commenter asserted, public health authorities tell consumers that the 
problem with poultry meat is not due to consumption because poultry is 
cooked. Comments questioned whether cross-contamination in the kitchens 
could possibly generate such high levels of foodborne illness. Related 
comments suggested that if cross-contamination was such a serious 
problem, the data would show more outbreaks and fewer single cases. 
Other comments suggested that the cost of salmonellosis attributed to 
poultry was high because of the high incidence of Salmonella 
enteritidis in eggs and requested that the Agency exclude any foodborne 
illness costs associated with eggs, because those issues are outside 
the scope of this rulemaking. Another comment cited an Australian 
finding that the Campylobacter strains that infect chickens are not the 
strains that primarily infect humans.
    The Department agrees that undercooked poultry is not a primary 
cause of foodborne illness. The preamble to the proposal stated that 
the majority of salmonellosis results from cross-contamination. The 
best available estimates for foodborne illness do suggest that a high 
incidence of illness is attributable to cross-contamination in 
kitchens--both household kitchens and food-service establishments.
    The comment suggesting that cross-contamination would have led to 
more outbreaks makes sense, if the available estimates on incidence 
were heavily

[[Page 38966]]

based on outbreak data. However, as mentioned in the proposal, it is 
widely recognized that CDC outbreak data do not provide accurate 
estimates of foodborne disease incidence. The outbreak data are more 
useful in identifying factors that lead to illness and have been used 
to estimate proportions of illness attributable to specific food 
groups. They do not play a major role in the overall incidence 
estimates. The existing incidence estimates are for total cases 
including both individual cases and multiple cases. The methodology 
used does not distinguish between outbreaks and single cases. Just as 
there are unreported individual cases of foodborne illness, there are 
unreported cases where entire households or portions of households 
experience foodborne illness due to cross-contamination in household 
kitchens. As discussed above, the estimates of foodborne illness were 
derived from both CDC outbreak data and community-based epidemiologic 
studies.
    The outbreak data (two or more individuals ill from the same 
source) are compiled by CDC from reports that are voluntarily submitted 
from state and local health authorities. The laboratory reporting 
system for Salmonella only captures information on those cases where a 
patient sees a doctor, the doctor collects a stool culture and sends 
the culture to a participating laboratory and the laboratory can 
perform the specific diagnostic test. The estimates for overall disease 
incidence are derived using both databases plus data collected from 
population-based studies in specific geographic areas. The current 
(initiative) collaborative surveillance project should improve the 
estimates in the future.
    The comment referring to the Australian finding is referring to an 
article by Korolik, et al, published in the May 1995 issue of the 
Journal of Clinical Microbiology, entitled, ``Differentiation of 
Campylobacter jejuni and Campylobacter coli strains by Using 
Restriction Endonuclease DNA Profiles and DNA Fragment Polymorphisms.'' 
The study was undertaken to determine if DNA fingerprinting 
technologies could identify strains of Campylobacter in chickens that 
cause disease in humans.
    FSIS reviewed the article and concluded that the study did not 
refute U.S. epidemiologic studies showing that approximately 50% of 
human Campylobacter infections are due to poultry. To confirm FSIS's 
interpretation of the study, a staff member contacted the author, Dr. 
Victoria Korolik, in Australia. She confirmed that her study does not 
shed doubt on the role of poultry in human Campylobacter infections.
4. Pathogens Addressed by the Rule
    While the proposed rule indicated that HACCP systems will be 
designed to control all public health hazards, the preliminary benefits 
analysis assumed that the primary benefits will come from controlling 
the three most common enteric pathogens of animal origin: Campylobacter 
jejuni/coli, E. coli O157:H7, Salmonella and one environmental pathogen 
Listeria monocytogenes. Two other pathogens--Clostridium perfringens 
and Staphylococcus aureus primarily become or create hazards in meat 
and poultry products as prepared in restaurants, other commercial 
kitchens, and in homes. Consequently, the proposed regulatory program, 
which focuses on the manufacturing sector, will not significantly 
affect the presence of these organisms on meat and poultry products.
    The public comments did not address the assumption that the 
proposed rule would have the most impact on the four pathogens 
identified above and that benefits would be most appropriately 
discussed in terms of reducing the level of these pathogens. This final 
RIA will continue to assume that the HACCP-based regulatory program 
will have the most impact on the four pathogens identified in the 
preliminary analysis.
    The preliminary benefits analysis also included an assumption 
concerning the percentage of the four pathogens that contaminate the 
meat and poultry supply at inspected establishments or grow from 
contamination that occurs at inspected locations. Based on the expert 
judgment of FSIS microbiologists, the preliminary benefit analysis 
assumed that 90 percent of the four pathogens result from contamination 
that occurs at inspected establishments.
    The public comments did not directly address the estimate that 
slaughter and processing establishments are the source of 90 percent of 
enteric pathogen contamination. There were, however, a large number of 
comments that cited studies or estimates that show or indicate that the 
majority of foodborne illness can be attributed to improper cooking, 
recontamination and other mishandling and abuse in the food service and 
home environment. Many comments cited data presented in the 1994 CAST 
Report which ``demonstrated'' that only 6.9 percent of outbreaks were 
``attributable'' to the food processing establishments. Other comments 
referred to ``a well-recognized fact that 97 percent of the problems 
with foodborne illness occur outside the realm of state and federal 
inspection.'' Other comments attributed the 97 percent figure to a 
Special Report by the American Association of Meat Processors. These 
types of comments were presented in a manner indicating that the 
commenters believe that the data attributing ``cause'' to the food 
service or home environment directly contradicts the Agency's estimate 
that inspected establishments are the source of 90 percent of the four 
pathogens addressed by this rule.
    In response, the Agency points out that the studies cited by 
commenters concluding that high percentages of foodborne illness are 
attributable to factors such as temperature abuse and mishandling do 
not conflict with either the assumption that slaughter and processing 
establishments are the source of 90 percent of enteric pathogen 
contamination or the assumption discussed later concerning the 
effectiveness of HACCP in reducing that contamination. Occurrence of 
foodborne disease is a multi-step process. The first, and critical, 
step is the introduction of a pathogen into or onto the raw product. If 
a pathogen is present, then subsequent temperature abuse or mishandling 
may permit bacterial counts to increase to levels which increase the 
likelihood that illness will occur; mishandling may result in cross-
contamination of other foods which are not cooked before being eaten; 
or improper cooking may not kill all pathogenic bacteria present in the 
product. In these instances, it may be said that the illness was 
``caused'' by improper handling. However, disease would not have 
occurred if the pathogen had not been present on the raw product in the 
first place.
    The CAST study included a table showing factors contributing to the 
occurrence of 1,080 outbreaks occurring from 1973 to 1982. That table 
consisted of data from the CDC national foodborne disease surveillance 
system that was published in an article in the Journal of Food 
Protection by Frank L. Bryan in 1988. The CAST study and journal 
articles use terminology like ``factors that contribute'' and address 
the location or type of employee/consumer where any mishandling or 
mistreatment of food occurred. The focus of these studies is to enhance 
our understanding of the sequences of events and behaviors that lead to 
foodborne illness since behavioral modification for the food preparer 
and consumer at the end of the food chain may have the greatest impact 
on the incidence of foodborne disease. Many of the comments are written 
in a manner that blurs the distinction

[[Page 38967]]

between factors in the kitchen that may permit an outbreak to occur 
from slaughter-origin contamination and those that would have caused an 
outbreak despite the absence of contamination of the raw ingredients.
    The comments referring to the CAST study or directly to CDC 
estimates have not interpreted the Foodborne Disease Outbreak 
Surveillance Data correctly. The standard CDC foodborne disease 
outbreak report form does not include a question about whether the food 
processing industry was involved, and while many foodborne outbreaks 
have a chain of causation, investigators may differ in their assessment 
of the point or points in the chain to which primary responsibility for 
occurrence of the outbreak should be assigned.
    The Bryan article used for the CAST study had the following summary 
concerning the role of food processing establishments: ``Many of the 
animals that enter abattoirs are either infected or contaminated with 
foodborne pathogens and further spread occurs during processing. Hence, 
abattoirs and raw-product processing establishments must accept some of 
the blame of spreading salmonellae and other pathogens to many 
carcasses and pieces of meat. These products are major sources of 
pathogens for food-service establishments and homes where further abuse 
(e.g., inadequate cooking or cross contamination) leads to outbreaks of 
foodborne illness.''
    The comments have not provided any basis for changing the expert 
judgment of FSIS microbiologists that inspected establishments are the 
source of 90 percent of the four pathogens addressed by the final rule. 
This final benefits analysis is based on this assumption.
5. Effectiveness of the Rule in Reducing Pathogens
    In accordance with the assumption that meat and poultry 
establishments are the source of 90 percent of the four pathogens 
addressed by the rule, the preliminary analysis calculated the benefits 
under a scenario where the proposed rule would eliminate essentially 
100 percent of those pathogens that enter the meat and poultry supply 
at inspected processing establishments. In other words, for the 
preliminary analysis, FSIS calculated an estimate of maximum benefits 
by assuming the rule would eliminate 100 percent of the 90 percent.
    By assuming this scenario, FSIS was not predicting that it believed 
that the rule would result in elimination of 100 percent of those 
pathogens in the manufacturing sector. Rather, the Agency was 
acknowledging that it has responsibility for having a food safety 
objective that recognizes the scope of the problem and attempts to 
reduce pathogens in that sector as much as possible, since without 
pathogens, no amount of subsequent abuse would result in foodborne 
illness.
    By presenting a sensitivity analysis in the proposal, FSIS intended 
to clarify that the benefit estimates were a maximum and not a 
prediction of what is likely to happen. The distinction was unclear to 
many commenters who expressed doubt that the proposed HACCP program 
would result in a 90 percent reduction in pathogens. A large number of 
comments on the potential effectiveness of HACCP programs contrasted 
the FSIS estimates with those contained in the recent study by the 
Institute of Food Science and Engineering, Texas A&M University, titled 
``Reforming Meat and Poultry Inspection: Impacts of Policy Options,'' 
(hereafter referred to as the IFSE study). Both FSIS and IFSE estimates 
are useful as assumptions rather than as quantitative predictions of 
potential effectiveness of HACCP.
    The ISFE study examined four policy options for addressing 
pathogens in the meat and poultry supply. One option called for 
mandatory HACCP for inspected slaughter and processing establishments 
and estimated that mandatory HACCP in inspected establishments would 
produce a 20 percent reduction in pathogens. The difference in the FSIS 
and IFSE estimates is not based on data but on assumptions for 
different ``HACCP'' scenarios.
    The HACCP program scenario considered in the IFSE study did not 
assume a mandatory pathogen reduction performance standard. Requiring 
process control without a standard could lead to processes that are 
well controlled at unacceptable pathogen levels. The Agency would agree 
that such a situation would result in less pathogen reduction. FSIS 
believes that a standard is necessary to encourage innovation and 
provide the impetus for continuing improvement and increasing 
effectiveness. In estimating effectiveness, the IFSE study noted that 
``with experience and additional research, it is possible that higher 
levels of reduction in pathogens could be achieved * * *''.
    Another major difference between the two program scenarios is that 
the IFSE program does not include a prerequisite requirement for SOP's. 
SOP's could cover potential sources of enteric and environmental 
pathogens that are not be covered under a HACCP plan. However, as 
discussed in Section I, this analysis discusses benefits of SOP's in 
terms of increased productivity for inspection resources and clarity of 
responsibilities.
    Several comments refer to the IFSE estimates as being more 
objective or ``scientific'' than those in the Agency's analysis. The 
IFSE authors characterize their own effectiveness estimates as ``the 
consensus judgment of the task force'' or ``the most reasonable 
expectation.'' The IFSE estimates are judgments, as are the Agency's 
estimates.
    A general comment related to the effectiveness issue stated that 
while HACCP remains an interesting theoretical concept, it is still 
only a concept that has never been tested on a meaningful scale under 
actual meat establishment conditions, and never proven to significantly 
improve the microbial quality of the finished product. Although HACCP 
has been tested in food processing establishments to the satisfaction 
of scientists, food technologists, and industry management to produce 
safe food, the Agency recognizes that the potential effectiveness of 
HACCP in reducing pathogens within a regulatory framework is unknown at 
the present time. FSIS conducted a pilot HACCP study in nine 
establishments from 1991 to 1993. Findings regarding pathogen reduction 
effectiveness were inconclusive. FSIS did not receive any data during 
the comment period from establishments currently operating HACCP 
systems. Rather than select an arbitrary effectiveness estimate, or use 
the maximum potential 100 percent estimate from the preliminary 
analysis, this RIA will present a range of effectiveness estimates and 
show the minimum level necessary to generate net benefits.
6. Estimated Reduction in Cost of Foodborne Illness
    Several comments focused on the issue that the relationship between 
pathogen reductions at the manufacturing stage and foodborne illness 
reductions is unknown. The comments recognize that the proposal did 
acknowledge that little data exist on the relationship between pathogen 
levels and incidence of illness. One comment pointed out that FSIS 
recognized that the pathogen testing requirements that are part of the 
proposal will help to elucidate the relationship between pathogen 
contamination and foodborne disease. The commenter concluded that it 
did not seem reasonable for the Agency to rely on an assumption, whose 
very validity can only be tested by the implementation of the proposal 
under examination, to justify the proposal.

[[Page 38968]]

Other commenters concluded that the Agency needed to develop better 
data or complete a thorough risk assessment that would establish the 
public health benefits of pathogen reduction before proceeding.
    The comments asking for better data or requesting a thorough risk 
assessment are not comments on the cost-benefits analysis. These 
comments imply there is insufficient evidence to support new pathogen 
reduction efforts. This issue is addressed in the preamble to the final 
rule. The comments have made a policy judgment with which the 
Department does not agree.
    For the benefits analysis included with the proposed rule, FSIS 
assumed that a reduction in pathogens will lead to a corresponding 
proportional reduction in foodborne illness. The Department notes that 
the IFSE study referred to favorably by many commenters used the same 
method for estimating public health benefits as did FSIS, i.e., a 
reduction in pathogens leads to a proportionate reduction in illness 
and death. The Agency is aware that the proportionate reduction method 
is an assumption that has not been tested or validated. However, the 
Agency also recognizes that research methodology for relating pathogen 
levels at establishments to incidence of illness is in its early 
developmental stages. Risk models for foodborne pathogens are likely to 
develop as the basis for regulatory decision-making in the future. The 
Agency believes the implementation of mandatory HACCP will improve food 
safety and protect public health while research in modeling risk 
associated with foodborne pathogens continues.
    The Agency has and continues to support any effort to improve the 
quality of data and methodology available for risk assessment of 
illness caused by foodborne biological agents. FSIS, FDA, CDC, and 
local public health departments are collaborating with state health 
departments and local investigators at five locations nationwide to 
identify more accurately the incidence of foodborne illness, especially 
illness caused by Salmonella and E. coli O157:H7.

G. Summary

    The final rule addresses four pathogens that are estimated to cause 
from $1.1 to $4.1 billion in annual illness and death costs 
attributable to meat and poultry products. The rule addresses 90 
percent of that cost of illness or from $0.99 to $3.69 billion 
annually. FSIS recognizes that the actual effectiveness of the final 
requirements in reducing pathogens is unknown, and presents a range of 
benefits based on reducing varying percentages of the $0.99 to $3.69 
billion in annual cost of foodborne illness addressed by this rule.

References

    International Commission on Microbiological Specifications for 
Foods (ICMSF). 1980. Microbial Ecology of Foods: Factors Affecting 
Life and Death of Microorganisms. Volume I. Academic Press, New 
York. Pp. 215-231.
    Rolfe, R.D. 1991. Population dynamics of the intestinal tract. 
In: Colonization Control of Human Bacterial Enteropathogens in 
Poultry. Ed. L.C. Blankenshipp, J.S. Bailey, N.A. Cox, S.E. Craven, 
R.J. Meinersmann, N.J. Stern. Academic Press, Inc., New York. Pp. 
59-76.
    Centers for Disease Control (CDC). 1988. Campylobacter isolates 
in the United States, 1982-1986. In: CDC Surveillance Summaries. 
June 1988. MMWR 1988; 37 (No. SS-2:1-13).
    Blaser, M.J. & L.S. Newman. 1982. A review of human 
salmonellosis: I. Infective dose. Reviews of Infectious Disease. 
4(6):1096-1106.
    Buchanan, R.L. & R.C. Whiting. 1996. Risk assessment and 
predictive microbiology. J. Food Protection. 31-36.
    Burmaster, D.E. & P.D. Anderson. 1994. Principles of good 
practice for the use of Monte Carlo techniques in human health and 
ecological risk assessments. Risk Analysis. 14(4):477-481.
    Council for Agricultural Science and Technology (CAST). 1994. 
Foodborne pathogens: Risks and consequences, Report No. 122, p. 87.
    Haas, C.N. 1983. Estimation of risk due to low doses of 
microorganisms: A comparison of alternative methodologies. Am. J. 
Epidemiol. 118:573-582.
    National Research Council. 1983. Committee on Institutional 
Means for Assessment of Risks to Public Health. Risk Assessment in 
the Federal Government: Managing the Process. National Academy 
Press, Washington, DC p. 191.
    Tappero, J.W. et al. 1995. Reduction in the Incidence of Human 
Listeriosis in the United States; Effectiveness of Prevention 
Efforts? Journal of the American Medical Association. 273(14):1118-
1122.
    Gellin, B., C.V. Broome, R. Weaver and A.W. Hightower. 
[Listeriosis Study Group.] Geographic Differences in Listeriosis in 
the U.S. (Abstract). In Program and Abstracts of the twenty-seventh 
International Conference on Antimicrobial Agents and Chemotherapy. 
p. 155. Washington, DC: American Society for Microbiology, 1987.

V. Cost Analysis

A. Introduction

    The final HACCP rule includes several regulatory components all 
directed at improving process control in meat and poultry operations in 
order to reduce the risk of foodborne illness associated with meat and 
poultry products. The requirements of the final rule are organized 
around the following three sections:
     Requirements that all inspected establishments develop and 
implement sanitation Standard Operating Procedures (SOP's) within 6 
months.
     Requirements that all inspected establishments develop and 
implement HACCP programs within the 18 to 42 month time period 
following publication. Scheduling will be based on establishment size.
     Requirements that (1) all establishments slaughtering 
cattle, swine, chickens, or turkeys, or producing a raw ground product 
from beef, pork, chicken or turkey comply with new pathogen reduction 
performance standards for Salmonella and (2) all establishments 
slaughtering cattle, swine, chicken or turkeys implement microbial 
testing programs using generic E. coli within 6 months. Compliance with 
the pathogen reduction performance standards for Salmonella will be 
required at the time the establishment is required to implement HACCP.
    This cost analysis is presented in three sections. The first 
section describes the methodology used in generating cost estimates. 
The next section addresses the regulatory flexibility designed to 
reduce the burden on small business. The last section presents the cost 
estimates for each regulatory requirement. For each broad requirement, 
the discussion of the cost estimates is organized using the following 
five topics:
     Summary of the requirements in the final rule identifying 
any changes from the proposal.
     Review of the cost estimates from the preliminary RIA.
     Summary of the comments related to the preliminary cost 
estimates.
     Response to the comments.
     Final cost estimates.

B. Methodology for Cost Analysis

    The final pathogen reduction/HACCP rule includes regulatory 
requirements that are directed at improving the control over food 
processing operations. In general, compliance with these requirements 
requires expenditures of time, i.e., employee hours to develop plans, 
monitor critical control points, record findings and collect and 
analyze samples. This final RIA is based on time required by four 
categories of employees that were defined in the supplemental cost 
analysis. These include the following:
     Quality Control manager earning $25.60 per hour.
     Supervisors or QC technicians that review findings and 
records at $18.13 per hour.

[[Page 38969]]

     Laboratory technicians earning $18.13 per hour.
     Establishment employees/production workers that would 
monitor sanitation and HACCP programs or collect samples at $12.87 per 
hour.
    The four categories of wages are based on 1993 data adjusted for 
1994 dollar inflation from the Bureau of Labor Statistics and Meat and 
Poultry Magazine and include a 33 percent overhead requirement for 
benefits such as health insurance and retirement contributions. Unless 
otherwise noted, the analysis assumes that all establishments and 
employees work a standard 52 week, 260 day, 2080 hour work year.
    This final cost discussion is based on retracing the steps and/or 
calculations of the preliminary analysis and discussing related public 
comments in the appropriate sections. Other comments that are related 
to the analysis but do not reflect directly on the methodology are 
summarized at the end of the analysis in Appendix A.
    This analysis makes frequent references to the Enhanced Economic 
Database. In 1994, the Research Triangle Institute (RTI) took a 
compilation of existing FSIS databases containing establishment 
production or inspection data and added data on annual sales and 
employment from sources that included Dun and Bradstreet and American 
Business List databases. Actual estimates for annual sales and number 
of employees were available for approximately 80 percent of the 
establishments. In other cases, estimates for sales and number of 
employees were developed using the employment/sales data for 
establishments producing the same type and volume of product.
    The enhanced database includes production data (number of head 
slaughtered, pounds of product produced) from 1993 for all federally-
inspected establishments in operation as of August 1994. The 
preliminary analysis and this final RIA combine 1993 production data 
with the population of federally and state- inspected establishments 
that were in operation as of August 1994. As of August 1994, there were 
6,186 federally inspected and 2,893 state inspected establishments. 
These 9,079 establishments include a total of 11,719 ``operations''--
2,597 red meat slaughter operations, 364 poultry slaughter operations 
and 8,758 further processing operations.
    This final analysis assumes a constant level of 9,079 inspected 
establishments. The analysis does not attempt to account for costs 
associated with exits from or entries into the marketplace. For 
operations that are entirely new, or include a new processing 
operation, the requirements for HACCP plans and sanitation SOPs will 
increase the one-time, up-front cost of entering the market. If 
marketplace entry involves the purchase of an existing business, the 
business will already have an existing HACCP plan and sanitation SOP. 
In these cases, the acquisition cost of the business would include the 
value of the existing HACCP plan and SOP.
    There should be minimal additional cost for HACCP and SOP plan 
development for new construction that expands a firm by replicating an 
existing operation in a new location. This type of new establishment 
can apply HACCP and SOP plans that have been developed for a similar 
existing establishment. This analysis has assumed that each 
establishment is independent and has not reduced cost estimates to 
account for firms that operate several similar establishments.
    The preliminary analysis developed cost estimates for three sizes 
of manufacturing establishments. Most of the costs that involve 
employee time are influenced by a number of factors including the 
physical size of the establishment, the volume of production, the type 
of production practices and the number or production lines. The 
preliminary analysis used the data on annual sales developed by RTI 
because the sales data correlated reasonably well with size and 
production volume data and the Agency had an estimate of sales for 
6,186 federally inspected establishments.
    For the preliminary analysis the Agency defined a large 
establishment as one with over $50 million in annual sales, a medium 
establishment as one with between $2.5 and $50 million and a small 
establishment as one with less than $2.5 million in annual sales. For 
calculating costs, the Agency collected data from the field based on 
these three size categories. Public comments provided good reason to 
change size definitions for implementation (regulatory flexibility) 
purposes and the Agency has done so for the final rule. This does not 
affect the accuracy of proposed or current cost estimates based on 
previously collected data. The final analysis uses the old categories 
for presenting cost data to facilitate comparisons and minimize 
confusion. To summarize, this cost analysis uses the terms high, medium 
and low volume producers for cost presentation that involves average 
establishment costs and uses the terms large, small and very small 
business for discussing regulatory flexibility. The cost and 
flexibility principles do not overlap in this analysis.
    Commenters pointed out that in comparing total costs with the value 
of current production, the preliminary analysis did not address impacts 
on producers, i.e., the costs that would be passed back to livestock 
producers. FSIS recognizes that some costs will be passed back to 
producers in terms of lower prices for live animals and other costs 
will be passed forward in terms of higher consumer prices. Other costs 
may have to be absorbed by slaughter and processing establishments. 
Because the necessary knowledge of empirical cost structures and supply 
and demand elasticities is inadequate, FSIS does not offer any 
quantitative estimates of the distribution of costs of this rule on 
various sectors of the production and marketing chain. The aggregate 
cost estimate establishes an upper bound on the costs any sector might 
ultimately bear.
    There are two types of potential costs that were not addressed in 
the preliminary cost analysis. The first type of cost is the cost of 
taking corrective action when routine monitoring of a CCP finds a 
deviation from a critical limit. The critical limit could be associated 
with assuring compliance with existing regulatory requirements or it 
could be a limit set to assure compliance with the new pathogen 
reduction standards for Salmonella or the criteria established for 
generic E. coli. Corrective action would also occur when FSIS would 
find a problem with either a HACCP plan or a sanitation SOP.
    The second type of potential cost is related to the question of 
whether existing processing methods are adequate to meet the pathogen 
reduction performance standards for Salmonella and the criteria for 
generic E. coli. It is expected that some establishments will have to 
make permanent changes to their existing production practices to have a 
HACCP-based program that assures compliance with the new standards and 
criteria. The final rule raises a third type of potential cost when it 
outlines the Agency's plans for using the results of its own Salmonella 
testing program for regulatory purposes. Whether or not this testing 
leads to industry testing costs depends on whether the government 
testing indirectly forces an establishment to regularly conduct its own 
testing.
    The preliminary analysis did address a fourth category of potential 
costs that includes the cost of necessary materials, such as 
thermometers and test kits, that establishments will need to

[[Page 38970]]

systematically monitor their processes. Recognizing that the rule does 
not make any equipment obsolete, the preliminary analysis suggested 
costs of from $10 to $20 per establishment. These costs were not 
included in the overall cost summary.
    Potential costs are addressed in this final analysis under Section 
V.D.2., Costs of Meeting Pathogen Reduction and Microbial Sampling 
Requirements.

C. Regulatory Flexibility

    The Regulatory Flexibility Act (P.L. 96-354) requires analyzing 
options for regulatory relief for small businesses. This section 
reviews the regulatory relief provided in the proposal, responds to 
comments related to the definition of small business used in the 
proposal and summarizes the regulatory relief for small business 
provided for in the final rule. In Section II, this analysis addressed 
the option of providing an exemption for small business noting that 
comments on an exemption were mixed with a substantial number of 
comments from small businesses strongly opposing an exemption.
    The proposed rule intended to spread the implementation of HACCP 
over a three year period. To minimize the burden on small 
establishments, they would be given a maximum time of 36 months to 
develop and implement their HACCP plans. A small establishment was 
defined as one with annual sales of less than $2.5 million.
    The decision to use the above definition generated a large number 
of comments. ``Very small'' establishments commented that they could 
not compete with a relatively ``large'' business with annual sales of 
$2.5 million. For example one commenter stated that: ``calling an 
establishment, small, that produces $2,500,000 worth of product 
annually is not fair to those establishments producing far less.'' 
Other comments suggested that by defining small at the $2.5 million 
level, the Agency demonstrated that it does not understand what a small 
business is. Comments from businesses with annual sales of $2.5 to 
$10.0 million or even $25.0 million stated that they should also be 
considered small businesses. Commenters also pointed out that other 
Federal agencies use different definitions. For example, one commenter 
noted that OSHA uses 50 employees as their criterion for a ``small 
business.'' Others commented that FSIS should or must use the existing 
definition of fewer than 500 employees published by the Small Business 
Administration (SBA).
    Several comments promoted a set of requirements distinguishing 
``small'' from ``very small'' establishments. ``Very small'' 
establishments would only be required to implement the proposed 
provisions on sanitation standard operating procedures, antimicrobial 
treatment of carcasses, and time and temperature provisions. They would 
be exempt from routine microbial testing and long-term provisions of 
HACCP as long as annual sales do not exceed $1 million (not counting 
``pass through''). The establishments would still be subject to 
incidental sampling for microbial testing as determined by the 
Administrator. Required implementation of the three near-term 
initiatives would be 12 months after publication of the final rule.
    The ``small'' establishments (between $1.0 and $2.5 million) would 
be required to implement SOPs, antimicrobial treatment, time and 
temperature provisions, and limited routine sampling, in proportion to 
the number of slaughtered animals and/or poundage of processed 
products. The establishments would still be subject to incidental 
sampling for microbial testing as determined by the Administrator. They 
would be exempt from long-term provisions of HACCP as long as annual 
sales, as defined above, do not exceed $2.5 million. The required 
implementation of all near-term initiatives would be six months.
    There were other comments that suggested variations on the above 
definitions and requirements for ``small'' and ``very small'' 
establishments. For example, one State department of agriculture 
recommended the same requirements for ``small'' and ``very small'' 
establishments but suggested that size criteria based on head 
slaughtered or pounds produced would be more practical. Another State 
department of agriculture recommended that a ``every small'' plant be 
defined based on the number of employees (no more than 20 full-time), 
slaughter volume (no more than 2,500 animals per year), or processing 
volume (100,000 pounds of meat and/or poultry products per year). The 
recommendation suggested that a plant in this category would be 
required to implement the provisions of the proposed rule pertaining to 
sanitation SOP's and time-temperature requirements. Antimicrobial 
treatment of carcasses would be voluntary, and such a plant would be 
exempted from microbial testing as proposed. Implementation of a HACCP 
program would be initially voluntary, and phased in with considerations 
in the areas of documentation and record-keeping for the limited work 
force.
    FSIS has considered the above regulatory framework for ``small'' 
and ``very small'' establishments. Some of the suggestions are no 
longer applicable because major provisions of the proposed rule have 
been dropped. FSIS believes it has addressed the other concerns in more 
appropriate ways.
    FSIS was aware of SBA Size Standards during the development of the 
proposed rule. If FSIS used the size standard for meat and poultry 
``manufacturing'' firms, over 94 percent of the federally inspected 
establishments would meet the criterion of having fewer than 500 
employees. FSIS is also aware that there are six different SBA size 
standards that apply to the 6,415 FSIS official establishments. FSIS 
determined the SBA size standards by themselves are not appropriate for 
meeting FSIS's need to sequence HACCP implementation.
    Table 7 shows the distribution of 6,415 official establishments by 
Standard Industrial Classification (SIC) code. The SIC codes were 
developed to promote the comparability of statistics describing various 
facets of the Nation's economy. The SIC codes were used as part of the 
Enhanced Economic Analysis Database developed by Research Triangle 
Institute to represent all FSIS inspected establishments. As can be 
seen from Table 7, a significant portion of official establishments are 
not in an SIC Code for manufacturing. Food manufacturing establishments 
have a 4-digit SIC Code beginning with 20. The Census of Manufacturers 
published by the Department of Commerce characterizes the meat and 
poultry manufacturing industry by summarizing data for SIC Code 2011--
Meat Packing Establishments, SIC Code 2013--Sausages and Other Prepared 
Meats, and SIC Code 2015--Poultry Slaughtering and Processing. The SBA 
Size Standards in Table 7 are published in the Code of Federal 
Regulations--13 CFR, Chapter 1, Section 121.601.
    In a written comment, the Office of Advocacy, Small Business 
Administration claimed that FSIS was wrong in concluding that one-third 
of federally inspected establishments would have the maximum time for 
compliance with HACCP requirements using the criterion of $2.5 million 
in annual sales. In supporting their claim, they cited U.S. Census 
Bureau data. However, Census data do not accurately describe the 
federally inspected meat and poultry industry. As shown in Table 7, the 
problem is that less than half of the firms are classified in the three 
4-digit SIC Codes identified above that define meat and poultry 
manufacturing. FSIS addressed this data

[[Page 38971]]

problem by contracting with RTI to develop a more accurate economic 
profile of federally inspected meat and poultry establishments.

                           Table 7.--Establishments Standard Industrial Classification                          
----------------------------------------------------------------------------------------------------------------
                                                                Cumulative                                      
     SIC code          Standard industrial       Number of       number of             SBA size standard        
                         classification       establishments  establishments                                    
----------------------------------------------------------------------------------------------------------------
2011..............  Meat packing                    1,503             1,503   500 employees.                    
                     establishments.                                                                            
5147..............  Meats and meat products.        1,312             2,815   100 employees.                    
2013..............  Sausages and other                939             3,754   500 employees.                    
                     prepared meats.                                                                            
2015..............  Poultry slaughtering and          438             4,192   500 employees.                    
                     processing.                                                                                
4222..............  Refrigerated warehousing          356             4,548   $18,500,000.                      
                     and storage.                                                                               
5421..............  Meat and fish markets...          309             4,857   $5,000,000.                       
5144..............  Poultry and poultry               268             5,125   100 employees.                    
                     products.                                                                                  
5141..............  Groceries, general line.          238             5,363   100 employees.                    
5812..............  Eating places...........          156             5,519   $5,000,000.                       
2038..............  Frozen specialities, nec          139             5,658   500 employees.                    
5142..............  Packaged frozen foods...          130             5,788   100 employees.                    
5411..............  Grocery stores..........           95             5,883   $20,000,000.                      
5149..............  Groceries and related              65             5,948   100 employees.                    
                     products, nec.                                                                             
9999..............  Not applicable..........           63             6,011                                     
2032..............  Canned specialities.....           61             6,072   1,000 employees.                  
2099..............  Food preparations, nec..           55             6,127   500 employees.                    
Other.............  All other SIC codes.....          288            6,415                                      
----------------------------------------------------------------------------------------------------------------
Note: The Enhanced Economic Analysis Database uses the number of active establishments as of August, 1994 and   
  identified 6,415 establishments as active official establishments. Of these 6,415, a total of 229 were        
  identified as cold storage/ID warehouses, universities or churches. From the 6,415 total, 6,186 federal       
  establishments were classified as processing, slaughter or combination operations. nec--(Not Elsewhere        
  Classified).                                                                                                  

    The final rule provides for sequencing HACCP implementation by 
establishment size, using the SBA definition of a small manufacturing 
business, i.e., a small business is an establishment with fewer than 
500 employees. Those establishments with 500 or more employees will be 
referred to as large establishments. In addition, in response to 
comments that there are hundreds of ``very small'' or ``micro'' 
establishments, the Agency will classify an establishment as ``very 
small'' if it has either fewer than 10 employees or annual sales of 
less than $2.5 million.
    This sequencing of HACCP responds to a large number of comments 
requesting that small businesses be given a longer period of time to 
implement HACCP requirements. Many small businesses stated they did not 
want to be exempt, but asked for more flexibility in implementing 
HACCP. Some commenters specifically requested five, eight or 10 years 
to implement HACCP.
    While the final rule does not provide for longer periods of five, 
eight or 10 years, it does substantially extend the implementation 
period for hundreds of small and very small establishments.
     To illustrate, the proposed rule would have required HACCP plans 
in over 2,100 establishments producing raw ground product within 12 
months. Under the final rule, over 1,800 of those establishments will 
have either 30 or 42 months to implement HACCP. The smallest 5,127 
establishments (2,893 state and 2,234 federal) will have an additional 
six months. The proposed rule called for implementation of a HACCP 
system in all ``small'' establishments by 36 months; the final rule 
allows 42 months for the newly defined ``very small'' category.
    Table 8 illustrates the distribution of 6,186 federally-inspected 
slaughter, processing, and combination establishments used for the 
sequencing of HACCP implementation in the proposed rule and in the 
final rule. There are 496 more establishments in the two smaller 
categories than there were in the proposal. As shown in Table 8, there 
are 353 large, 2,941 small and 2,892 very small federally-inspected 
establishments.

    Table 8.--Size Categories for Federally Inspected Establishments    
------------------------------------------------------------------------
                                                              No. of    
      Establishment  category            Definition       establishments
------------------------------------------------------------------------
                              Proposed Rule                             
------------------------------------------------------------------------
High volume.......................  >$50 million........          849   
Medium volume.....................  $2.5-$50 million....        3,103   
Low volume........................  <$2.5 million.......        2,234   
  Total...........................  ....................        6,186   
------------------------------------------------------------------------
                    Final Rule (Sequencing of HACCP)                    
------------------------------------------------------------------------
Large.............................  500                353   
                                     Employees.                         
Small a...........................  10-499 Employees....        2,941   
Very small b......................  <10 Employees or            2,892   
                                     <$2.5 Million.                     
  Total...........................  ....................       6,186    
------------------------------------------------------------------------
a New definition of small includes 2,445 establishments that were medium
  volume establishments plus 496 that were high volume for the          
  preliminary analysis.                                                 
b New definition of very small includes the 2,234 establishments that   
  were low volume establishments plus 658 that were medium volume       
  establishments for the preliminary analysis.                          

D. Final Cost Estimates

1. Sanitation Standard Operating Procedures
    a. Summary of Requirements. The final rule requires that all 
inspected establishments develop and implement Sanitation SOP's within 
6 months after publication of the final rule. The proposed rule would 
have required the implementation of SOP's within 90

[[Page 38972]]

days. To facilitate the development of SOP's and to provide maximum 
flexibility, the Agency will not prescribe any specific format or 
content but will provide guidelines to assist inspected establishments 
in developing written SOP's. There will not be any FSIS approval of the 
written documents. With the exception of the implementation schedule, 
the requirements for SOP's in the final rule are the same as those in 
the proposed rule.
    b. Review of Preliminary Cost Estimates. The preliminary cost 
analysis identified separate costs for SOP plan development and SOP 
recordkeeping where recordkeeping was defined as observing or verifying 
procedures, recording findings, reviewing records and maintaining 
files. FSIS assumed that the Sanitation SOP's would be developed by a 
quality control manager at a cost of $25.60 per hour. FSIS estimated 
that it would cost an average of $128, $256 and $640 for low, medium 
and high volume establishments to develop Sanitation SOP's.
    The preliminary cost analysis assumed that Sanitation SOP's 
observation and recording for low, medium and high volume 
establishments would take 15, 25 and 45 minutes per day by an employee 
earning $12.87 per hour and that supervisory review of records would 
take 5, 10, and 20 minutes by an employee earning $18.13 per hour. In 
developing these time estimates for recording and reviewing records, 
FSIS recognized that the time required would be influenced by a number 
of factors including the physical size of the establishment, the volume 
of production, the type of production practices and the number of 
production lines. The estimates are based on program judgement of the 
time required to conduct two sets of sanitation observations per day, 
one for preoperational sanitation procedures and one for operational 
sanitation.
    Using the above inputs, the annual costs for recording and 
reviewing Sanitation SOP's records for low, medium and high volume 
establishments would be approximately $1,230, $2,180 and $4,080, 
respectively, based on a 260-day, 2,080 hour work year. These costs 
were adjusted upward to approximately $1,242, $2,204 and $4,104 to 
account for the cost of maintaining records.
    The preliminary analysis also included training costs of $62, $155 
and $372 for low, medium and high volume establishments. Instructing an 
employee in verification and recording procedures was assumed to take 
2, 5 and 12 hours, respectively involving both a QC technician ($18.13 
per hour) and a production worker ($12.87 per hour). Total training 
cost was, therefore, $31 per hour. Total per establishment Sanitation 
SOP's costs, as estimated in the preliminary analysis, are summarized 
in Table 9.

                           Table 9.--Summary of Sanitation SOP Costs Per Establishment                          
                                                    [Dollars]                                                   
----------------------------------------------------------------------------------------------------------------
                                                                                              Total             
                                                       Plan           Annual       Training   first    Recurring
              Establishment category                development   recordkeeping      cost      year     annual  
                                                       cost            cost                    cost      cost   
----------------------------------------------------------------------------------------------------------------
Low..............................................           128            1,242         62    1,432       1,242
Medium...........................................           256            2,204        155    2,615       2,204
High.............................................           640            4,104        372    5,116       4,104
----------------------------------------------------------------------------------------------------------------

    Using the per establishment costs from Table 9, total aggregate 
costs were calculated for all inspected establishments as shown in 
Table 10. Establishments with an existing written sanitation program 
were assumed to have only 50 percent of the plan development costs 
because these establishments would have to modify an existing plan 
rather than start from the beginning. Establishments with existing 
sanitation plans include the 287 establishments with TQC programs and 
46 slaughter establishments with PQC sanitation programs. It was also 
assumed that these 333 establishments would not require training to 
implement a sanitation SOP.

                  Table 10.--Costs of Sanitation SOP's                  
                         [Dollars in thousands]                         
------------------------------------------------------------------------
                                                       First            
       Establishment category             No. of        year   Recurring
                                      establishments   costs     costs  
------------------------------------------------------------------------
High................................          849      $4,276     $3,484
Medium..............................        3,103       8,079      6,839
Low.................................        2,234       3,185      2,775
                                     -----------------------------------
  Subtotal..........................        6,186      15,540     13,098
                                     ===================================
State...............................        2,893       4,143      3,593
                                     -----------------------------------
  Total.............................        9,079      19,683    16,691 
------------------------------------------------------------------------
Note: For preliminary RIA, all State establishments were assumed to be  
  low volume establishments.                                            

    c. Comments on Preliminary RIA. Comments on proposed requirements 
for sanitation Standard Operating Procedures (Sanitation SOP's) focused 
on the cost of recordkeeping. In the preliminary cost analysis, 
recordkeeping included observation (i.e., verifying the procedures), 
recording findings, supervisory review of records and maintenance of 
files. One commenter stated that the cost of recordkeeping for their 
company would be approximately $10,000 annually.
    A state inspected establishment, currently participating as a pilot 
establishment for HACCP/sanitation plans in their state program, 
indicated that they spend several hours each week verifying procedures 
and have weekly costs of at least $50 to keep the paperwork for their 
sanitation plan current. Their annual cost for keeping paperwork 
current would, therefore, be at least $2,600. This state establishment 
also stated that they had used an estimated $3,000 to $4,000 designing 
an SOP and that was with the assistance of two universities, several 
suppliers and their state inspection program. It took nine months to 
put the plan together.
    Comments at public hearings indicate that there is a lot of 
uncertainty as to what FSIS expects in Sanitation SOP's. At one of the 
public hearings the owner of a ``small'' establishment stressed the 
importance of guidance and training with respect to what is expected in 
terms of recordkeeping.
    d. Response to Comments.

[[Page 38973]]

    The Agency recognizes that the costs reported by the state 
establishment participating in a pilot program are substantially higher 
than the costs used in the preliminary analysis. The reported 
development time of nine months is also longer than the allowed 
implementation period. FSIS believes that the reported pilot project 
involving two universities, several suppliers and a state program has 
far exceeded the expectations of the rule. The same is true for the 
comment suggesting recordkeeping costs of $10,000 per year.
    FSIS has now developed model Sanitation SOP's and a guideline for 
developing Sanitation SOP's. These documents should clarify FSIS 
expectations. FSIS believes that these documents are consistent with 
the cost estimates used in the preliminary analysis.
    There is some reason to believe that the estimated cost for 
Sanitation SOP's in the preliminary analysis is conservative, that is, 
a possible overstatement of costs. Whether the costs associated with 
Sanitation SOP's are totally new or just how they may be modified over 
time can only be determined in individual establishment situations. For 
example, task verification and recordkeeping are costs that can be 
reduced through efficient management and allocation of resources and 
should decrease with experience. In many cases the tasks can be 
integrated with current duties.
    For many establishments, the cost of Sanitation SOP's should be 
offset by changes in the approach to sanitation. Under current 
procedures, slaughter operations can not begin until inspection 
personnel have given their approval. Under the new procedures all 
establishments will be able to commence daily operations without USDA 
approval upon successful completion of the preoperational portion of 
their Sanitation SOP. When operational sanitation problems are 
identified, corrected and documented as they occur by the 
establishment, establishment officials will spend less time interacting 
with inspectors or responding to inspection findings. For example, 
federally inspected establishments currently provide written responses 
to approximately 700,000 to 800,000 Processing Deficiency Records 
(PDRs) per year. Over 70 percent of these PDRs are for sanitation 
deficiencies.
    Finally, while FSIS recognizes that keeping sanitation records will 
be a new task, FSIS does not necessarily view the time spent verifying 
sanitation procedures as a new regulatory cost. FSIS is not changing 
any sanitation requirements. It is also true that FSIS has had an 
ongoing problem getting all establishments to comply with existing 
sanitation requirements. It can, therefore, be argued that some 
establishments have not conducted the necessary verification to assure 
compliance with existing regulations or have used FSIS employees to 
conduct sanitation verification.
    e. Final Cost Estimates. After considering the comments, FSIS does 
not see a need to adjust the cost estimates shown in Tables 9 and 10. 
The final aggregate cost estimates for SOP's are those shown in Table 
10. The costs in Table 10 assume that the requirement for SOP's does 
not lead to new compliance costs associated with new regulatory 
obligations apart from paperwork and recordkeeping. The analysis 
assumes that satisfactory sanitation is achieved one way or another 
under current procedures and that the changes that will occur with 
SOP's have more to do with issues of responsibility and efficient use 
of inspection resources. It follows that, for the most part, this 
provision of the rule will have no direct effect on the rate, extent or 
severity of pathogenic contamination, and thus will also have no effect 
on the rate, extent, or severity of foodborne illness. This is not 
saying there will be no change in establishment or employee conduct. In 
fact, FSIS expects to see more sanitation activities conducted at the 
firm's initiative rather than following inspection findings.
2. Costs of Meeting Pathogen Reduction and Microbial Sampling 
Requirements
    a. Summary of Requirements. The final rule implementing HACCP-based 
programs establishes pathogen reduction performance standards for 
Salmonella. The rule both establishes the standards and defines the 
procedures the Agency will use to measure and assure compliance with 
the standards. The rule does not specify a minimum testing requirement 
for Salmonella. The pathogen reduction performance standards apply to 
an estimated 5,522 inspected establishments, 2,682 establishments that 
slaughter cattle, hogs, chicken or turkeys and another 2,840 
establishments that do not slaughter, but produce raw ground product 
from beef, pork, chicken or turkey. If an establishment slaughters two 
species, e.g. cattle and hogs, the establishment would be subject to 
the standards for both cattle and hogs. The Agency's testing program 
would, however, be directed at the predominant species. If an 
establishment both slaughters and processes a raw ground product from 
that same species, the Agency will test the ground product. If an 
establishment produces more than one variety of ground product, the 
Agency intends to sample each.
    The proposed rule included the same standards but contained a 
different approach for enforcement. The proposed rule included the 
requirement that each of the 5,522 affected establishments would 
collect and analyze one sample for each species or variety of raw 
ground product for Salmonella on a daily basis. The establishments 
would maintain records from these tests that would be reviewed by 
inspection program personnel to determine compliance. The proposed rule 
did not include a discussion of how the Agency would use the test 
results in a program for regulatory enforcement.
    Under the proposal, the results from each establishment's 
Salmonella testing program were also to be used as a measure of process 
control. This final rule requires that all 2,682 slaughter 
establishments implement sampling programs using generic E. coli as a 
measure of process control for slaughter and sanitary dressing 
procedures.
    b. Review of Preliminary Cost Estimates. As discussed earlier under 
methodology, the preliminary RIA did not attempt to analyze the overall 
impact of complying with the new pathogen reduction standards. The 
preliminary RIA did include a detailed analysis of the costs associated 
with the requirement that slaughter and raw ground processing 
establishments collect and analyze samples for Salmonella on a daily 
basis. The laboratory analysis required only a positive-negative 
finding, i.e., the proposed rule did not require the analysis necessary 
to determine the number of bacteria present in the sample. The cost of 
meeting the proposed requirement would vary depending on whether or not 
the establishment had an inhouse laboratory. It was assumed that 
approximately 20 percent of samples would be collected in 
establishments with in-house laboratories. For an establishment without 
a laboratory the total cost for each sample was estimated as shown in 
Table 11.

 Table 11.--Cost of a Salmonella Sample Analysis for Establishments With
                         No In-House Laboratory                         
                                (Dollars)                               
------------------------------------------------------------------------
                            Component                              Cost 
------------------------------------------------------------------------
Average Private Laboratory Cost.................................   22.60
Shipping........................................................    7.00

[[Page 38974]]

                                                                        
Collecting and Packaging........................................    3.75
                                                                 -------
  Total.........................................................   33.35
------------------------------------------------------------------------



    The establishment without an in-house laboratory would also be 
required to train an individual to perform aseptic sampling. The cost 
components for a Salmonella test at an in-house laboratory were 
estimated for the preliminary RIA as shown in Table 12.

 Table 12.--Cost of a Salmonella Sample Analysis For Establishments with
                         An In-House Laboratory                         
                                [Dollars]                               
------------------------------------------------------------------------
                            Component                              Cost 
------------------------------------------------------------------------
Laboratory Supplies.............................................    5.90
Collecting and Preparing Sample.................................    5.28
Laboratory Analysis (0.5 hours at $18.13 per hour)..............    9.07
                                                                 -------
      Total.....................................................   20.25
------------------------------------------------------------------------

    Since the requirements in the final rule have changed 
substantially, this section will present only a brief summary of what 
was a relatively complex analysis to estimate the total industry 
sampling costs associated with the proposed requirements. The costs 
associated with the proposed Salmonella testing requirement are 
summarized in Tables 13 and 14. Table 13 shows the different cost 
components.

                          Table 13.--Component Costs for Microbial Sampling as Proposed                         
                                                  [$ Thousands]                                                 
----------------------------------------------------------------------------------------------------------------
                                                                                           Sample               
                                                                Training     Sampling    collection   Recording 
                   Establishment category                     for aseptic      plan         and       and review
                                                                sampling   development    analysis       time   
----------------------------------------------------------------------------------------------------------------
High........................................................           10          508        5,267          242
Medium......................................................          514        1,473       20,555          887
Low.........................................................          604          959       18,624          606
                                                             ---------------------------------------------------
      Subtotal..............................................        1,128        2,939       44,446        1,735
                                                             ===================================================
State.......................................................          998        1,588       21,150          688
                                                             ---------------------------------------------------
      Total.................................................        2,126        4,527       65,597        2,423
----------------------------------------------------------------------------------------------------------------


                          Table 14.--Aggregate Costs of Microbial Sampling as Proposed                          
                                                  [$ Thousands]                                                 
----------------------------------------------------------------------------------------------------------------
                                                                   Number of raw                                
                     Establishment category                           product       First year       Recurring  
                                                                    operations         costs           costs    
----------------------------------------------------------------------------------------------------------------
High............................................................             793           6,027           5,509
Medium..........................................................           2,301          23,429          21,443
Low.............................................................           1,498          20,792          19,230
                                                                 -----------------------------------------------
      Subtotal..................................................           4,592          50,248          46,181
                                                                 ===============================================
State...........................................................           2,481          24,424          21,838
                                                                 -----------------------------------------------
      Total.....................................................           7,073          74,672          68,020
----------------------------------------------------------------------------------------------------------------
Note: All state establishments were assumed to be low volume producers. Columns may not add to totals due to    
  rounding.                                                                                                     

    Table 14 summarizes the first year and annual recurring costs. 
Training and sampling plan development costs are one-time first year 
costs. Sample analysis and recording costs are both recurring annual 
costs. The following notations help characterize the estimated costs 
from the preliminary analysis:
     Training and plan development costs were based on a total 
of 7,073 raw product operations. This total is based on a count of meat 
slaughter, poultry slaughter and raw ground processing operations. 
Sample collection and analysis and recording and record review costs 
were based on a count of 8,329 species-specific operations, i.e., the 
total of beef slaughter, pork slaughter, raw ground processing, etc. 
Thus, an establishment with beef slaughter, pork slaughter and raw 
ground processing would count as two operations for training and plan 
development, but three operations for sampling and recordkeeping.
     The proposed requirement of one sample per day per species 
resulted in low volume federal establishments and state establishments 
accounting for over 60 percent of the estimated first year costs (See 
Table 14).
     The analysis underestimated costs in that with existing 
data it was necessary to assume that the 3,029 establishments with raw 
ground product operations produced only one product. The proposal would 
have required 2 samples per day if an establishment produced both raw 
ground beef and raw ground pork on a daily basis.
     The analysis overestimated costs in that it counted 
operations for minor species or kind ( e.g. sheep and goats). The 
proposal did not cover sheep, goats, equine, ducks, geese, etc.
     The analysis overestimated costs in that it assumed that 
every establishment

[[Page 38975]]

with multiple operations was running each operation every day (260 days 
per year).
     Each of the 7,073 operations would require a sampling 
plan--25 hours for a QC manager at $25.60 per hour for a total of $640 
per plan. At $640 per plan, 7,073 plans totaled $4.53 million as shown 
in Table 13.
     The analysis assumed that 5,275 (approximately 75 percent) 
of the 7,073 operations would have to train an individual to perform 
aseptic sampling. The total of 5,275 includes all 1,498 low volume raw 
operations, 1,275 (55.4%) of the 2,301 medium volume raw operations, 25 
(3.2%) of the 793 high volume operations and 2,477 (99.8%) of the State 
inspected raw product operations. Training was estimated at $403 per 
operation--8 hours with a trainer at $37.50 per hour and a trainee at 
$12.87 per hour. Training for 5,275 operations at $403 per operation 
would cost $2.13 million as shown in Table 13.
     Recording and review time was estimated at 5 minutes per 
day for each of the 8,329 species-specific operations. Five minutes per 
day equals approximately 21.7 hours per year or an average of 
approximately $291 per year per operation based on wages of $18.13 and 
$12.87 per year (average of $13.43). The total is $2.42 million as 
shown in Table 13. Since the requirement was one sample per day per 
species, the cost estimates could also be viewed as 5 minutes per 
sample.
    c. Comments on the Preliminary RIA. Similar to the preliminary 
analysis, the public comments focused on the cost of required 
Salmonella sampling and did not address the overall impact of meeting 
the proposed pathogen reduction performance standards for Salmonella. 
The proposed regulation would have required daily sampling for each 
species or kind slaughtered and each type (meat or poultry) of raw 
ground product per establishment per day. Comments from individual 
establishments indicated that some small establishments could be 
required to take 5 or more samples per day. A ``small'' establishment 
currently slaughtering three different species (beef, swine and lamb) 
and producing multiple raw ground products estimated they would need 
approximately 2,200 samples per year at a cost of approximately $77,000 
per year. That is over eight per day based on a 260 day work year. A 
``small'' ground meat processing establishment estimated they would 
need over 500 samples from approximately 350,000 pounds of annual 
production.
    Several comments from ``small'' establishments pointed out that the 
proposed sampling program placed a disproportionate burden on small 
establishments from two perspectives. First, ``small'' establishments 
have less production over which to spread the cost of sampling. Second, 
smaller establishments tend to be the ones that slaughter more species 
or kind and produce more varieties of raw ground product. Other 
comments pointed out that the proposed Salmonella testing would not 
provide a good procedure to validate process control.
    There were also comments that referred to the cost of the product 
that is lost or damaged during sample collection. A turkey processor 
noted that the value of a 40 pound tom is $63.60 at wholesale price. 
The same comment pointed out that shipping costs could be very high, 
especially if next day service is required.
    Several comments noted that the IFSE study estimated costs for 
microbiological testing that were far higher than the cost estimates 
provided by FSIS. Another commenter noted that microbiological testing 
is being proposed to correct a deficiency of an inspection system that 
is currently unable to detect microbial contamination of meat. If 
mandatory inspection is a federally funded program, why not the 
``correction'' of the system?
    Most of the comments referred to the cost of the proposed 
requirement and were not comments on the methodology used to determine 
costs in the preliminary analysis. One comment that did address the 
cost methodology had calculated the cost of a Salmonella test at $38.00 
to $44.50 per test where FSIS used a cost of approximately $33.00 to 
$34.00. There was some confusion concerning the proposed requirements. 
Some comments indicated the establishments believed that they would 
have to test every product line. Other comments based estimates on a 
far costlier test for Salmonella indicating they assumed the test would 
require information concerning the number of bacteria present, not just 
a positive-negative result.
    There were also comments that suggested that FSIS has overestimated 
the cost of microbial sampling because, as the amount of laboratory 
analysis increases, the cost per sample will probably decrease. Other 
commenters pointed out that demand will lead to simpler and less costly 
new methods development.
    d. Response to Comments. The changes in the final rule eliminate 
the issues raised by most of the comments. The comments concerning the 
burden on ``small'' establishments made a convincing argument that 
``small'' establishments could not afford to implement the microbial 
sampling program as proposed. The final rule does not include a minimum 
testing requirement for Salmonella. Each individual establishment can 
conduct the level of testing they deem necessary to provide assurance 
that they are meeting the pathogen reduction performance standards for 
Salmonella.
    The Agency agrees with public comments and conclusions reached at 
technical conferences that the proposed Salmonella testing would not 
have provided a good measure of process control. The final rule 
requires that all slaughter establishments implement testing programs 
using generic E. coli to validate control of slaughter and sanitary 
dressing procedures. After reviewing all public comments and other 
materials made available during the comment period, FSIS concluded that 
using generic E. coli is more practical. Generic E. coli is generally 
present in the feces of mammals and birds and is, therefore, an 
excellent indicator of fecal contamination. It has a higher frequency 
than Salmonella and can be tested and quantified relatively less 
expensively and, therefore, provides a more efficient measure of 
control of slaughter and sanitary dressing procedures. Testing for 
generic E. coli is also easier for in-house establishment laboratories.
    By basing E. coli sampling programs on production volume, the 
Agency is responding to small establishment concerns over equity of the 
regulatory burden. In addition, establishments with very low production 
will be required to conduct sampling for only a limited time period 
each year. Sampling will only be required for slaughter establishments. 
Establishments slaughtering more than one kind of poultry or species of 
livestock will be required to sample only the kind or species 
representing the most production. There will also be provisions for 
decreasing the number of samples after implementation of HACCP plans 
and provisions for using alternative generic E. coli sampling programs 
in cases where the establishment can present data demonstrating control 
of slaughter and sanitary dressing procedures.
    The comments referring to the value of lost product identified a 
cost that was not addressed in the preliminary analysis. Such costs 
will not be a factor for the final rule because beef and pork samples 
collected by FSIS will use the wet sponge swab technique and poultry 
samples will be collected using a whole

[[Page 38976]]

bird rinse. In both cases, no product will be damaged or lost.
    With respect to comments referring to high microbial sampling costs 
identified by the IFSE study, FSIS notes that the Agency's preliminary 
cost estimates were based on the proposed regulatory requirement of one 
test per species (carcass or raw ground product) per day for 
Salmonella. The IFSE study based their per establishment costs on a 
microbiological testing program currently being used in a beef 
slaughter establishment. The cost estimates generated by the IFSE study 
were not related to the testing program outlined in the proposed rule.
    The comments were correct that FSIS based the preliminary cost 
analysis on existing laboratory methods and on current laboratory cost 
estimates. The comments suggesting less expensive methods are only 
speculative. There is no way to estimate potential new methods. While 
there is no way to predict the effect of increased demand on costs, it 
seems reasonable to expect that, in the long run, laboratory analysis 
costs per sample will go down as more firms implement microbial 
sampling programs. FSIS notes that short run costs could actually 
increase as demand goes up faster than the supply of laboratory 
capability. In the long run, however, establishments should benefit 
from quantity discounts and lower fixed costs per sample as the total 
number of analyses increases.
    e. Final Cost Estimates. The final rule requires that all 
establishments slaughtering cattle, hogs, chickens or turkeys or 
producing a raw ground product from these species or kind meet a new 
pathogen reduction performance standard for Salmonella. This 
requirement applies to an estimated 5,522 establishments as shown in 
Table 15. Because the standard has been established using the baseline 
studies that estimate a national prevalence by carcass, the Agency does 
not have an estimate for the number of establishments that are 
currently meeting the standard. The baseline studies do not provide 
data on how pathogen levels vary between establishments and include 
data from only the larger establishments that represent most of the 
production.

Table 15.--Establishments Affected by the Pathogen Reduction Performance
                                Standard                                
------------------------------------------------------------------------
                                        Very                            
              Category                 small    Small    Large    Total 
------------------------------------------------------------------------
Cattle and hog slaughter............    1,876      376       66    2,318
Poultry slaughter...................      100      121      143      364
Raw ground processing...............    1,413    1,358       69    2,840
                                     -----------------------------------
      Total.........................    3,389    1,855      278    5,522
------------------------------------------------------------------------

    This analysis of how the Salmonella standards will impact the 5,522 
establishments will, by necessity, be primarily a qualitative 
discussion. The analysis will, however, develop two scenarios that can 
be used to present a range of potential impacts.
    Since the focus of this rule is about reducing pathogens in or on 
raw meat and poultry products, it is anticipated that the potential 
costs are greatest for those slaughter establishments that are 
currently not meeting the new pathogen reduction performance standards. 
For slaughter establishments, the potential costs take one of two 
forms.
    First, even though the rule does not require establishments to test 
for Salmonella, the Agency recognizes that some establishments may 
conduct their own Salmonella testing programs to avoid failing a series 
of tests conducted by the Agency. Thus, it can be argued that the 
Agency's intent to implement establishment specific testing for 
Salmonella is indirectly requiring the industry to routinely monitor 
their Salmonella levels to assure they will be in compliance.
    The manner in which FSIS will implement its Salmonella testing 
program should help keep establishment costs down. During the first 
phase, referred to as pre-implementation testing, FSIS will test 
product from each slaughter or raw ground operation and share those 
results with the establishment. Thus, before FSIS begins the actual 
enforcement of the Salmonella performance standards, the Agency will 
provide each establishment with a status report on Salmonella 
incidence. This pre-implementation testing will precede HACCP 
implementation, which occurs from 18 to 42 months after publication of 
the final rule. The pre-implementation results will assist the 
establishments in preparing for implementation of HACCP and the 
pathogen reduction performance standards. Establishments with low 
incidence of Salmonella will have some level of assurance that they are 
already meeting the new Salmonella standards.
    The second type of potential cost relates to the question of 
whether firms will have to make permanent changes in their processing 
or production practices in order to comply with the pathogen reduction 
performance standards for Salmonella. Reducing pathogens for slaughter 
establishments involves either modifying the incoming animals or birds, 
improving the dressing procedures so as to reduce contamination during 
procedures such as hide removal and evisceration, or using 
interventions such as antimicrobial treatments to kill or remove the 
pathogens following contamination. For many establishments, the process 
of implementing HACCP programs may, by itself, improve the dressing 
procedures sufficiently to meet the new standard. Other establishments 
may have to choose between slowing production lines, modifying some 
attribute of their incoming live animals or birds, or adding post-
dressing interventions such as the new steam vacuum process or 
antimicrobial rinses.
    This analysis will examine the two types of costs for the three 
industry segments of poultry slaughter, meat slaughter and raw ground 
processing. The analysis develops two cost scenarios to estimate the 
impact of the new pathogen reduction standards for Salmonella. As 
discussed earlier, the Agency does not have an estimate for the number 
of establishments that are currently meeting the standards.
    The two cost scenarios are based on three general premises. The 
first premise is that a certain portion of large establishments will 
take whatever action is necessary to provide assurance that they are 
meeting all regulatory requirements. The second premise is that the 
establishments that are typically having problems controlling 
operations today will also have problems meeting the Salmonella 
standards. The low cost scenario is based on these first two premises. 
FSIS has historically found serious control problems in from 5 to 10

[[Page 38977]]

percent of establishments. The recent 1,000 establishment review found 
serious control problems in 8.9 percent of 358 randomly selected 
establishments. The 1993 review of establishments with the New Turkey 
Inspection System found 3 of 26 establishments with problems with 
product ready for shipment. A 1991-1992 survey of poultry reprocessing 
found that while only 2 percent of poultry is reprocessed off-line, 
from 5 to 10 percent of the establishments had very high reprocessing 
rates.
    The high cost scenario is based on a third premise that (1) 
approximately half of the affected establishments are currently not 
meeting the standards and that (2) most large establishments and the 
majority of smaller establishments will take some action to assure 
compliance with the Salmonella standards.
    As shown in Table 15, there are 2,318 cattle or swine slaughter 
establishments that must meet the pathogen reduction performance 
standards for Salmonella. The Agency does not have information that 
would indicate that Salmonella testing is routinely conducted by a 
major segment of the beef or pork industry. The baseline studies have 
shown a one percent positive rate for steers and heifers and a 2.7 
percent positive rate for cows and bulls. In addition, the Agency does 
not know how, or if, beef and pork establishments would respond to the 
Agency's Salmonella testing initiative. Given the relatively low levels 
of Salmonella, most establishments will probably choose to depend on 
the assurance provided by a validated, well functioning HACCP program.
    To develop a low cost scenario, the Agency assumes that the 66 
large establishments would initiate daily testing using in-house 
laboratories ($20.25 per analysis--$347,490 per year) and that half of 
the 376 small establishments would conduct weekly testing at outside 
laboratories ($33.35 per analysis--$326,030 per year). Under a high 
cost scenario, the large establishments would conduct 8 tests per day 
($2.78 million per year), the small establishments would all conduct 
one test per week ($652,059 per year) and half (938) of the very small 
establishments would conduct a test each month ($375,388 per year). The 
low and high Salmonella sampling costs for cattle and hog slaughter 
operations are summarized in Tables 16 and 17, respectively.
    Beyond testing, there is the issue of whether the required actions 
of developing and implementing process control procedures will, by 
themselves, be sufficient to meet the Salmonella standards or whether 
changes in processing methods will also be required. FSIS recognizes 
that beef and pork dressing procedures involve a lot of manual steps 
and, therefore, it is reasonable to assume that substantial pathogen 
reduction can be accomplished through training and careful monitoring 
of the dressing procedures. This is especially true for the low volume 
establishments that do not have automated lines and use what is known 
as the ``bed kill'' dressing process.
    For slaughter establishments that do have to make process 
modifications, there are several options available. First, FSIS is 
aware of establishments that are testing live animal washing systems. 
Second, the preliminary analysis included estimates for the cost of 
using different antimicrobial treatments for varying sizes of cattle or 
hog slaughter establishments. The lowest cost option was a hot water 
spray system with no cabinet. The cost for that system was estimated at 
$.08 per carcass or approximately $8.78 million annually for all cattle 
and hog establishments. In contrast, a pre-evisceration acid spray 
system with both a pre-wash spray cabinet and a sanitizing cabinet was 
estimated at $.79 per carcass for a low volume establishment. A TSP 
system for cattle was estimated at $.85 per carcass for a low volume 
establishment.
    The preliminary analysis noted that 23 establishments were already 
using acetic or lactic acid sprays on carcasses either before or after 
evisceration. Other establishments had requested approval for citric 
acid, TSP, or hot water.
    Third, FSIS has now approved the new steam vacuum systems for beef 
and pork operations. The installation of a steam vacuum system is 
estimated at $10,000 per establishment, with expectations that 
increased use will result in lower prices. Annual increased utility 
costs to run a steam vacuum system are estimated at $4,000. Maintenance 
cost is estimated at 5 percent or $500 per year.
    For a low cost option, it is assumed that 10 percent of the large 
establishments must install a steam vacuum system to meet the new 
requirements and that half of 376 small establishments must use a hot 
water rinse at $.08 per carcass. The initial costs for the steam 
systems would be $70,000. Annual operating costs would be $31,500. 
Annual operating costs for hot water rinses on half the small 
establishment production would be $915,000.
    Under a high cost option, it is assumed that half (33) of the large 
establishments would have to install steam systems and that all small 
and very small establishments would use hot water rinses. The initial 
cost for steam systems would be $330,000. Annual operating costs would 
be $148,500. Annual costs for hot water rinses would be $2,075,387. The 
low and high process modification costs for cattle and hog slaughter 
operations are summarized in Tables 16 and 17, respectively.
    As shown in Table 15, there are an estimated 2,840 establishments 
that produce raw ground products using ingredients from other 
establishments. These establishments do not have the same opportunities 
to reduce Salmonella levels as do slaughter establishments. They can 
control growth by avoiding temperature abuse and can limit cross-
contamination, but basically they must depend on the Salmonella levels 
of their incoming product in order to meet the performance standards. 
These establishments may choose to test incoming product in order to 
eliminate suppliers whose product is found to be positive. Larger 
establishments that are important customers of other suppliers may 
choose to include pathogen requirements in their purchase 
specifications.
    For a low cost scenario, this analysis assumes that the 69 large 
firms would analyze one sample per day using in-house laboratories 
($20.25 per analysis) and that 10 percent (136) of the small firms 
would test one sample per week using an outside laboratory ($33.35 per 
analysis). Under a high cost scenario, this analysis assumes that half 
(679) of the small firms would test one sample per week and that the 
large firms would double their sampling. Under each scenario, it is 
assumed that the large establishments would begin testing 12 months 
after publication and the small establishments 24 months after 
publication. These starting dates correspond with the end of the 
Agency's pre-implementation testing. The low and high Salmonella 
sampling costs for raw ground processors are summarized in Tables 16 
and 17, respectively.
    As shown in Table 15, there are 364 poultry slaughter operations 
that will be required to meet the new pathogen reduction performance 
standards for Salmonella. FSIS believes that almost all of the larger 
establishments in the poultry industry currently conduct routine or 
periodic analyses for Salmonella and will use their ongoing testing 
programs to (1) establish and validate their HACCP controls to assure 
they will initially comply with the new pathogen reduction performance

[[Page 38978]]

standard, and (2) periodically verify continuing compliance. Therefore, 
the costs for additional Salmonella testing in the poultry industry 
will be minimal.
    For cattle and hog operations, this analysis used the cost of 
antimicrobials from the preliminary analysis in estimating possible 
process modification costs. In contrast, for the poultry industry, 
meeting the pathogen reduction performance standards is clearly not 
analogous to meeting the proposed antimicrobial requirement. The 
preliminary analysis assumed that 90 percent of all high volume poultry 
processors and 70 percent of all low or medium volume processors 
already meet that proposed requirement.
    FSIS recognizes that many poultry establishments may have to modify 
existing procedures to meet the new standards for Salmonella. Where 
cattle and hog dressing operations still include many manual procedures 
that can be easily controlled by improved training and monitoring, the 
poultry slaughter industry is highly automated, increasing the 
probability that process control may require modifications of 
equipment, facilities, or incoming product. However, because there is 
extensive vertical integration in the poultry industry, many firms have 
the added option of controlling Salmonella in the live birds. There is 
evidence that controlling Salmonella in feed and controlling rodents in 
poultry houses can have a substantial impact on the level of Salmonella 
in birds entering the slaughter facility.
    In the late 1980's, FSIS tested some alternative processing methods 
at an establishment in Puerto Rico. Two methods included a counterflow 
scalder and a hot rinse immediately following the scald tank. At the 
time, FSIS recognized that it may be expensive to retrofit an existing 
establishment with a counterflow scalder because of the physical space 
and plumbing required.
    Recognizing that other options are available, this analysis 
develops potential cost estimates based on the addition of TSP rinses. 
TSP rinse systems for the poultry industry are relatively expensive. It 
is currently estimated that a TSP installation would cost $40,000 per 
line with an operating cost of $0.003 per broiler or $0.014 per turkey.
    As a low cost option, FSIS assumes that 36 large poultry 
establishments (27 broiler and 9 turkey establishments) will add TSP 
systems. Average broiler production is estimated at 35 million and 
average turkey production at 6 million. Annual average operating cost 
are, therefore, $105,000 for a chicken slaughter operation and $84,000 
for a turkey slaughter operation. Each large poultry establishment is 
assumed to have 2 lines. Small establishments were assumed to average 
1.5 lines.
    As a high cost option, FSIS assumes that 182 (100 large and 82 
small) poultry establishments will have to add TSP systems to meet the 
new requirements. The 182 establishments include 136 chicken and 46 
turkey slaughter establishments. The total low cost scenario for 
poultry slaughter operations is summarized in Table 16. The high cost 
scenario is summarized in Table 17.

                          Table 16.--Salmonella Testing and Process Modification Costs                          
                                            [Low Cost Scenario--$000]                                           
----------------------------------------------------------------------------------------------------------------
                 Industry sector cost category                   Year 1    Year 2    Year 3    Year 4    Year 5+
----------------------------------------------------------------------------------------------------------------
Sampling by Raw Ground Processors.............................         0       363       599       599       599
Process Changes for Cattle and Hog Slaughter Operations.......         0        86       489       947       947
Sampling by Cattle and Hog Slaughter Operations...............         0       347       674       674       674
Process changes for poultry slaughter operations..............         0     4,676     3,591     3,591     3,591
                                                               -------------------------------------------------
      Total...................................................         0     5,472     5,353     5,811     5,811
----------------------------------------------------------------------------------------------------------------


                          Table 17.-- Salmonella Testing and Process Modification Costs                         
                                           [High Cost Scenario--$000]                                           
----------------------------------------------------------------------------------------------------------------
                 Industry sector cost category                   Year 1    Year 2    Year 3    Year 4    Year 5+
----------------------------------------------------------------------------------------------------------------
Sampling by raw ground processors.............................         0      $727    $1,904    $1,904    $1,904
Process changes for cattle and hog slaughter operations.......         0       404     1,063     2,101     2,224
Sampling by cattle and hog slaughter operations...............         0     2,780     3,807     3,807     3,807
Process Changes for Poultry Slaughter Operations..............         0    12,988    18,979    18,144    18,144
                                                               -------------------------------------------------
      Total...................................................         0    16,899    25,753    25,956    26,079
----------------------------------------------------------------------------------------------------------------

    After the initial implementation years, the annual cost for all 
three industry sectors is approximately $5.8 million for the low cost 
scenario. Under the high cost scenario, the total recurring industry 
cost of meeting the new performance standards is $26.1 million per 
year.
    The high and low cost scenarios have addressed the potential costs 
of process modification when establishments find they are not meeting 
critical limits set to assure compliance with the new pathogen 
reduction standards for Salmonella. While the scenarios have addressed 
permanent process modifications, it is also reasonable to assume that 
meeting the Salmonella standards would involve some day-to-day process 
adjustments, i.e., corrective actions that do not involve adding new 
procedures or new equipment. One example would be the decision to 
reduce line speeds on a day when the incoming live animals are 
particularly dirty. The Agency believes that many establishments 
already take this type of precautionary action.
    Under HACCP, there will presumably also be some costs associated 
with corrective actions related to critical limits set for the purpose 
of meeting existing regulatory limits. As discussed earlier under 
methodology, the preliminary analysis did not include any costs for 
taking corrective actions when such deviations from critical limits 
occur. If this rulemaking were implementing a new regulatory program 
where none had previously existed, one might expect to see 
establishments experiencing considerable additional costs due to 
temporary production down-time, the need to rework or condemn product 
or the need to

[[Page 38979]]

investigate the causes of deviations and develop corrective action 
plans. Meat and poultry inspection is, however, an existing regulatory 
program with a broad range of requirements that are well understood by 
the regulated industry and enforced by the daily presence of an 
inspector. The system already includes procedures whereby 
establishments are (1) implementing corrective actions for almost a 
million written Processing Deficiency Records (PDRs) annually, (2) 
developing written Establishment Improvement Programs (PIPs) when 
continuing problems with facility maintenance are observed, and (3) 
developing Corrective Action Plans when establishments experience 
serious ongoing problems in complying with existing sanitation or other 
regulatory requirements. In addition, the regulations already include a 
wide array of time and/or temperature requirements for cooking and 
chilling processed products. Many of the existing regulations have been 
developed with the standards of food safety in mind that are 
represented by critical limits under HACCP.
    Within this existing regulatory framework establishments already 
experience down-time and expend considerable resources discussing 
causes of problems and plans for preventing future occurrences. Thus, 
from the perspective of looking at the existing system, FSIS does not 
envision that establishments will experience a significant increase in 
the costs of corrective action and believes the new system can help 
establishments avoid situations that currently cost them resources to 
correct. FSIS views the new program as a more effective way of assuring 
that establishments meet already established health and safety related 
requirements. For example, the requirement that establishments develop 
and implement sanitation SOPs does not include any change in existing 
sanitation standards. Under the existing system, FSIS takes 
responsibility for determining when establishments meet the standard 
and when they can operate. Under the new program, establishments will 
have to document their procedures and take responsibility for 
implementing those procedures before they begin operations. FSIS 
recognizes that some establishments will have to spend more time 
cleaning facilities and equipment. Today, many establishments conduct 
sanitation procedures only after inspection has identified a problem. 
FSIS does not, however, view such increased costs of sanitation as a 
cost of this rulemaking. If this rule imposes such additional costs, it 
is because the HACCP-based program will inherently provide improved 
enforcement procedures in situations where firms have been substituting 
the inspector's sanitation review for their own production control.
    In summary, under the broader cost category of process modification 
and corrective action, FSIS has concluded that the cost of this rule is 
most appropriately addressed under the subject of potential costs 
associated with meeting the new pathogen reduction standards. The low 
and high cost scenarios provide the estimates for these potential 
costs. As will be discussed under the next topic of generic E. coli 
testing, these low and high cost scenarios include the types of actions 
establishments would take if they were also experiencing continuing 
difficulty in meeting criteria established for generic E. coli.
    The final rule also requires that all establishments that slaughter 
cattle, swine, chickens or turkeys implement testing programs for 
generic E. coli to validate control of slaughter and sanitary dressing 
procedures. All samples will be analyzed for quantity, i.e., number of 
bacteria present. These testing programs will use production volume as 
the basis for determining the frequency at which establishments will 
conduct testing for generic E. coli. The frequencies for E. coli 
testing for each slaughter species are as follows:

cattle--1 test per 300 carcasses
swine--1 test per 1,000 carcasses
chickens--1 test per 22,000 carcasses
turkeys--1 test per 3,000 carcasses

These frequencies were selected so that, in the subgroup of 
establishments accounting for 99 percent of total production for each 
species, the 5 percent of establishments with the highest production 
volume would each have to conduct a minimum of 13 E. coli tests, or one 
test window, each day. With these frequencies, 90 percent of all 
cattle, 94 percent of all swine, 99 percent of all chicken, and 99 
percent of all turkeys will be slaughtered in establishments conducting 
a minimum of one E. coli test per day.
    The above frequencies notwithstanding, all slaughter establishments 
must conduct sampling at a minimum frequency of once per week. 
Establishments with very low volumes, slaughtering at or below 6,000 
cattle, 20,000 swine (or a combination of such livestock not to exceed 
a total of 20,000, with a minimum of 6,000 cattle), 440,000 chickens, 
or 60,000 turkeys annually, will only be required to sample once per 
week until a sampling window has been completed where the results 
indicate that the slaughter and dressing process is under control. Once 
these criteria have been met, these establishments will be required to 
complete a new sampling window once each year, or when a change has 
been made in the slaughter process or personnel. This cost analysis 
assumes that the average low volume establishment will have to complete 
two windows (26 samples) each year before they meet the established 
criteria, recognizing that some establishments will meet the criteria 
on their first window and others may require three or more.
    The final rule also provides that slaughter establishments 
operating under a validated HACCP system 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 establishmen's slaughter and 
sanitary dressing controls. In addition, the final rule allows an 
establishment to use an existing generic E. coli sampling program if it 
can provide the data necessary to show that the existing plan is 
assuring adequate control. This analysis has not attempted to account 
for alternative sampling frequencies. It is likely that any reduction 
in generic E. coli sampling would be offset by alternative verification 
procedures.
    The estimated component costs for collecting, shipping and 
analyzing a generic E. coli sample at a commercial laboratory are shown 
in Table 18.

     Table 18.--Cost of a Generic E. coli Sample Analysis Commercial    
                               Laboratory                               
                                [Dollars]                               
------------------------------------------------------------------------
                            Component                              Cost 
------------------------------------------------------------------------
Average private laboratory cost.................................   13.00
Shipping........................................................    7.00
Collecting and packaging........................................    3.75
                                                                 -------
      Total.....................................................   23.75
------------------------------------------------------------------------

    The component costs for collecting and analyzing a generic E. coli 
sample at an FSIS field laboratory are shown in Table 19.

[[Page 38980]]



    Table 19.-- Cost of a Generic E. coli Sample Analysis FSIS Field    
                               Laboratory                               
                                [Dollars]                               
------------------------------------------------------------------------
                            Component                              Cost 
------------------------------------------------------------------------
Sample collection supplies......................................    1.45
Sample collection (0.5 hrs/$18.60 per hr).......................    9.30
Laboratory supplies.............................................    2.90
Laboratory analysis (0.5 hrs/$18.60 per hr).....................    9.30
                                                                 -------
      Total.....................................................   22.95
------------------------------------------------------------------------

    Based on the above average cost estimates, this final RIA uses a 
per sample cost of $24 per analysis, recognizing that establishments 
with in-house laboratories will be able to conduct sample analysis at 
lower costs. In using the average cost of $24 per sample, FSIS is 
providing an upper bound estimate. The corresponding cost per sample 
for Salmonella was $33.35 at a commercial laboratory. Thus, using 
generic E. coli instead of Salmonella for process control validation 
has reduced the per sample cost by approximately 30 percent.
    Aggregate annual sampling costs were estimated by applying the 
sampling frequencies to annual production data recorded by the Animal 
Disposition Reporting System (ADRS), an existing Agency database. The 
ADRS includes the total annual production in terms of number of 
livestock or poultry slaughtered for each federally inspected 
establishment. Table 20 summarizes estimates for the number of samples 
that will need to be collected and analyzed each year by the 364 
inspected poultry slaughter operations. As shown in Table 20, the 364 
establishments will be required to analyze 419,123 samples annually. 
Table 21 summarizes estimates for the number of samples that will need 
to be collected and analyzed each year by the 2,318 inspected cattle 
and swine slaughter operations. As shown in Table 21, the 2,318 
establishments will be required to analyze 252,640 samples annually.
    The smallest 2,098 slaughter operations (less than 6,000 cattle, 
20,000 swine, 60,000 turkeys and 440,000 chickens) will be required to 
analyze one sample per week until they demonstrate compliance with 
established criteria. This analysis assumes an average of 26 samples 
per establishment per year, recognizing that some may need more and 
others less. These 2,098 smaller slaughter operations (over 78 percent 
of the total 2,682) will not be required to conduct any further 
analyses within a given year unless major changes to facilities, 
equipment or personnel occur.
    Tables 20 and 21 were constructed assuming that all establishments 
operate on a 52 week, 260 day, 40 hours per week, 2,080-hour work-year. 
As discussed above, this final RIA does not attempt to account for 
possible reductions in sampling frequency in establishments where the 
establishment can demonstrate an existing acceptable alternative 
program or where alternative frequencies are an integral part of 
successful HACCP verification procedures.
    Tables 20 and 21 incorporate data from the preliminary analysis 
showing that there are 1,328 state-inspected slaughter establishments, 
with an estimated 1,270 slaughtering cattle or swine and 58 
slaughtering poultry. Based on additional data collected in July 1995, 
FSIS anticipates that 50 of the state-inspected cattle or swine 
slaughtering establishments will exceed the limits of 6,000 cattle or 
20,000 hogs and will be required to conduct a minimum of one sample per 
week on an ongoing basis. It is further assumed that none of these 
establishments will have to conduct more than one per week, i.e., 
cattle slaughter is under 15,600 (300 x 52) and swine slaughter is 
under 52,000 (52 x 1,000). The other 1,220 state-inspected cattle or 
swine establishments would average 26 samples per year (2 windows). The 
July 1995 data indicate that all 58 state-inspected establishments 
slaughtering poultry process fewer than 60,000 turkeys and 440,000 
chickens annually.

                    Table 20.--Required E. Coli Sampling for Poultry Slaughter Establishments                   
----------------------------------------------------------------------------------------------------------------
    Annual slaughter production          Number                               Average sampling rate     Annual  
              category               establishments  Sampling range per day     per establishment      samples  
----------------------------------------------------------------------------------------------------------------
Chickens over 45.8 million.........             60   Over 8 per day........  10.9 Per Day..........      170,300
Chickens 5.72 to 45.8 million......            125   1-8 per day...........  4.7 per day...........      152,230
Chickens 440,000 to 5,720,000......             23   1 per week-1 per day..  1.9 per week..........        2,215
Turkeys over 6.24 million..........             18   Over 8 per day........  12.7 per day..........       59,540
Turkeys 780,000 to 6,240,000.......             25   1-8 per day...........  4.8 per day...........       31,330
Turkeys 60,000 to 780,000..........              5   1 per week-1 per day..  2.7 per week..........          700
Chickens under 440,000 and Turkeys             108   NA....................  One per week (26              2,808
 under 60,000.                                                                weeks).                           
                                    ----------------------------------------------------------------------------
      Total........................            364   NA....................  NA....................      419,123
----------------------------------------------------------------------------------------------------------------
NA--Not applicable.                                                                                             


           Table 21.-- Required Generic E. coli Sampling for Swine and Cattle Slaughter Establishments          
----------------------------------------------------------------------------------------------------------------
    Annual slaughter production         Number of                             Average sampling rate     Annual  
              category               establishments      Sampling range         per establishment      samples  
----------------------------------------------------------------------------------------------------------------
Cattle over 780,000................             16   10 or more per day....  14.8 per day..........       61,750
Cattle between 78,000 and 780,000..             50   1-10 per day..........  3.2 Per Day...........       41,340
Hogs over 2,080,000................             17   8 or more per day.....  11.6 per day..........       51,090
Hogs between 260,000 and 2,080,000.             29   1-8 per day...........  4.0 Per Day...........       30,290
Cattle between 6,000 and 78,000 and/           216   One per week--one per   1.5 per week..........       16,430
 or hogs between 20,000 and 260,000.                  day.                                                      
Under 6,000 cattle and under 20,000          1,990   NA....................  One per week (26             51,740
 Hogs.                                                                        weeks).                           
                                    ----------------------------------------------------------------------------
      Total........................          2,318   NA....................  NA....................      252,640
----------------------------------------------------------------------------------------------------------------
NA--Not applicable.                                                                                             


[[Page 38981]]


    The total costs for meeting the final requirements for generic E. 
coli sampling in poultry and livestock slaughter establishments are 
summarized in Tables 22 and 23. These tables use the same cost 
estimates as the preliminary analysis for requirements such as plan 
development, training and recording and reviewing analytical results. 
Plan development is $640 per plan. The preliminary analysis assumed 
that 75 percent of operations will require training for aseptic 
sampling at $403 per operation. Recording and reviewing laboratory 
results averages 5 minutes per sample at an average wage of $13.43.
    As shown in Table 22, implementation costs (training and sampling 
plan development) for generic E. coli sampling in poultry 
establishments will be $286 thousand. For cattle and swine 
establishments, the implementation costs are $2.34 million as shown in 
Table 23. Annual recurring costs total $10.5 million for for the 364 
poultry establishments and $6.35 million for the 2,318 cattle and swine 
establishments. The total implementation costs for all 2,682 slaughter 
establishments are $2.63 million. The total recurring costs are $16.85 
million.
    In addition to the required sampling costs, there is the question 
of whether there will be additional compliance costs for establishments 
where test results indicate the performance criteria generic E. coli 
are not being met. In addressing this question, FSIS considered several 
factors. First, FSIS acknowledges that some establishments will find 
they are in compliance with the pathogen reduction standards for 
Salmonella, but are not meeting the performance criteria for generic E. 
coli. Second, the fact that the performance criteria are not 
established as enforceable regulatory standards does not mean that 
there will not be compliance costs. Third, the compliance actions 
identified for meeting the Salmonella standards (steam vacuum system, 
TSP systems and hot water rinses), are the same actions establishments 
would likely employ to achieve compliance with the performance 
criteria.

     Table 22.--Costs for Implementing Generic E. coli Sampling Programs in Poultry Slaughter Establishments    
                                             [Dollars in Thousands]                                             
----------------------------------------------------------------------------------------------------------------
                                                 Number of                                Samples               
                                              establishments    Training     Sampling    collection   Recording 
             Production Category                (number of    for aseptic      plan         and       and review
                                                  annual        sampling   development    analysis   (recurring)
                                                 samples)                               (recurring)             
----------------------------------------------------------------------------------------------------------------
Turkeys Under 60,000; Chickens Under 440,000            108                                                     
                                                    (2,808)            44           69           67            3
Turkeys Between 60,000 and 780,000; Chickens                                                                    
 Between 440,000 and 5,720,000..............             28                                                     
                                                    (2,915)             6           18           70            3
Turkeys over 780,000; Chickens over                                                                             
 5,720,000..................................            228                                                     
                                                  (413,400)             3          146        9,992          463
                                             -------------------------------------------------------------------
      Total.................................            364                                                     
                                                  (419,123)            53          233       10,059          469
----------------------------------------------------------------------------------------------------------------


       Table 23.--Costs for Implementing Generic E. coli Sampling Programs for Cattle and Swine Slaughter       
                                                 Establishments                                                 
                                             [Dollars in Thousands]                                             
----------------------------------------------------------------------------------------------------------------
                                                 Number of                                Samples               
                                              establishments    Training     Sampling    collection   Recording 
             Production category                (number of    for aseptic      plan         and       and review
                                                  annual        sampling   development    analysis   (recurring)
                                                 samples)                               (recurring)             
----------------------------------------------------------------------------------------------------------------
Cattle Under 6,000; Hogs Under 20,000.......          1,990                                                     
                                                   (51,740)           802        1,274        1,242           58
Cattle Between 6,000 and 78,000; Hogs                                                                           
 Between 20,000 and 260,000.................            216                                                     
                                                   (16,430)            54          138          394           18
Cattle over 78,000; Hogs over 260,000.......            112                                                     
                                                  (184,470)             1           72        4,427          206
                                             -------------------------------------------------------------------
      Total.................................          2,318                                                     
                                                  (252,640)           857        1,484        6,063          283
----------------------------------------------------------------------------------------------------------------

    After considering the above factors, FSIS concluded that if the low 
cost scenario for compliance with Salmonella standards proves to be 
more accurate, there will likely be more separate compliance costs for 
generic E. coli. As the costs for Salmonella compliance go up, the 
likelihood of separate generic E. coli costs goes down. It is important 
to note that under the high cost scenario, all cattle and swine 
slaughter establishments are using the steam vacuum system or a hot 
water rinse and half of all poultry slaughter establishments are using 
TSP systems. Under this scenario, it is difficult to imagine that any 
establishments would

[[Page 38982]]

still be failing to meet the performance criteria for generic E. coli.
    FSIS considered the possibility that the smaller establishments 
conducting only seasonal testing would increase testing to cover the 
whole year to provide better assurance of control over sanitary 
dressing procedures. However, FSIS rejected this possibility after 
considering the cost pressures on small businesses. FSIS would 
certainly not expect to see these establishments use both expanded 
testing and hot water rinses.
3. HACCP Programs--Plan Development and Annual Reassessment Costs
    a. Summary of Requirements. The proposed rule included a 
requirement that each inspected establishment develop a written HACCP 
plan for each distinct ``process'' conducted on the premises. The 
proposed rule identified nine process categories that would require 
separate HACCP plans. Each plan would include: identification of the 
processing steps which present hazards; identification and description 
of the CCP for each identified hazard; specification of the critical 
limit which may not be exceeded at the CCP (and if appropriate a target 
limit); a description of the establishment monitoring procedures; a 
description of the corrective action to be taken if the limit is 
exceeded; a description of the records which would be generated and 
maintained regarding this CCP; and a description of the establishment 
verification activities and the frequency at which they are to be 
conducted.
    The requirements in the final rule for HACCP plans are essentially 
the same. The final rule requires that each establishment conduct a 
hazard analysis and then develop a comprehensive HACCP plan that covers 
each hazard identified. The final rule has eliminated the nine process 
categories because the sequencing of HACCP implementation will be based 
on establishment size and not on process categories. The final rule 
also includes the provision that each plan be reassessed on an annual 
basis.
    b. Review of Preliminary Cost Estimates. Using existing databases 
(PBIS and ADRS) FSIS estimated that the 6,186 federally inspected 
establishments would require 16,899 HACCP plans, an average of 2.73 
plans per establishment. It was assumed that each of the 2,893 state 
inspected establishments would have 2.1 plans per establishment for a 
total of 6,120 plans. The total number of plans for all establishments 
is, therefore, 23,019. The Agency requested specific comments on the 
assumptions used to estimate the number of state plans, but received 
none. In estimating the cost of HACCP plan development for federally 
inspected establishments, FSIS used the following cost estimates as 
shown in Table 24.

                 Table 24.--HACCP Plan Development Costs                
------------------------------------------------------------------------
                                                     Plan sequence      
               Plan difficulty                --------------------------
                                                First    Second   Third 
------------------------------------------------------------------------
Easy.........................................    4,000    2,000    1,000
Moderate.....................................    8,000    4,000    2,000
Difficult....................................   12,500    6,250    3,125
------------------------------------------------------------------------

    Table 24 accounts for both the complexity or difficulty of the plan 
and the experience gained by developing previous plans. The table was 
developed from several sources including discussions with a number of 
private sector food consultants and the results of the HACCP Pilot 
Program Cost Findings study which was conducted by RTI and completed in 
August 1994. The RTI Study found that the nine pilot establishments 
reported plan development costs ranging from $607 to $15,750.
    For state establishments, FSIS assumed an average cost of $2,000 
for 6,120 plans. For the federally-inspected establishments, the above 
table generated an average cost of approximately $2,020 per plan. The 
resulting average cost is relatively low because the preliminary 
analysis credited each establishment with having developed one plan 
prior to HACCP because of the need to develop plans for sanitation 
SOPs, microbial sampling and time-temperature controls. It was assumed 
that the experience gained in developing plans for these three near-
term interventions could be applied to their first HACCP plan.
     The total cost for developing 23,019 plans was estimated 
at approximated $46.4 million ($34.14 million federal and $12.24 
million state) spread over a 3 year implementation period.
    c. Comments on the Preliminary RIA. There were several specific 
comments on the cost of developing a HACCP plan. Examples include:
      To write each plan would cost around $9,000.
       Average time to draft a plan is 300 hours.
      Average time of 300 hours at $125 per hour ($37,500).
      An average of $5,000 per establishment.
      Approximately $1,000 to $1,500 per establishment.
    More general comments stated that FSIS had underestimated or 
overestimated the cost of plan development or that FSIS should develop 
or pay for the cost of developing plans. There were also comments that 
indicate that some establishments believed that they would be required 
to have a separate plan for each product they produce.
    d. Response to Comments. The comments that suggested FSIS had 
overestimated costs or had developed an upper limit on implementation 
costs, pointed out that a market driven response to the rule would 
likely cut costs. The market would increase the number of consultants 
which would be available at reduced costs, especially for small 
establishments that are most likely to employ outside consultants. 
While FSIS agrees that the number of available consultants will 
increase and that the hourly cost for outside assistance will likely 
decrease, the Agency notes that Table 24 was developed with those 
factors in mind. The discussions with private sector food consultants 
focused on projected costs, recognizing that costs would decrease as 
more consultants became available and the overall level of industry 
expertise and experience increased.
    The comments included a wide range of estimates for the cost of 
developing a HACCP plan. Most of the specific cost estimates contained 
in the comments were within the ranges presented in Table 24. The 
comments do not provide a compelling reason to modify Table 24, 
especially since FSIS has an ongoing effort to develop implementation 
aids for establishments that will help keep plan development costs 
down. In addition to generic models that will be available at least six 
months before any mandatory requirement, FSIS is developing or 
considering: (1) Information publications, such as a HACCP Handbook 
that explains how a establishment can effectively and economically 
incorporate the seven principles into its operations; (2) training 
videos and computer programs that present HACCP implementation guidance 
in alternative formats; (3) models for onsite HACCP training of 
establishment employees; and (4) a catalog of hazards with examples of 
control measures and generic plans for each slaughter and processing 
category described in the proposed rule. FSIS is also planning to 
sponsor in-establishment demonstration projects to generate real-world 
information and guidance about near-term and HACCP implementation 
issues in small businesses.
    FSIS will also continue its technical assistance to state programs 
by including states' training officials in

[[Page 38983]]

Federal training efforts, by facilitating state access to and use of 
federal computer support systems, and by expansion of state/federal 
cooperative efforts through the Conference for Food Protection, the 
National Association of State Departments of Agriculture, the 
Association of Food and Drug officials, and the Meat and Poultry 
Inspection Advisory Committee. Also, FSIS' plans for in-establishment 
demonstration projects referenced above will focus on small 
establishments under State regulation as well as those under Federal 
regulation.
    The findings from the nine pilot establishments reported in the RTI 
study were based on conditions existing in the 1991-1992 time period. 
Many factors have changed since then including the number of available 
HACCP consultants, the number of trained individuals, the number of 
courses available and the general level of knowledge concerning the 
implementation of HACCP principles in food processing establishments. 
These factors should help drive plan development cost down.
    The 1994 RTI study noted that: ``Several participants commented 
that there is a lot more discussion and information about HACCP in the 
trade press and elsewhere today than there was even three years ago. 
Without exception, participants felt that USDA could reduce the costs 
of HACCP--especially training and HACCP plan development costs--by 
making as much information about HACCP available as possible.''
    In response to comments that FSIS should develop or pay for the 
development of plans, FSIS believes that these suggestions would 
diminish the principle of having industry take ownership and 
responsibility for the production process. This principle is a key 
factor in HACCP. If FSIS developed or paid for the plans, it would 
detract from the establishment's assuming ownership and responsibility 
for the HACCP plans. FSIS also believes that government funding of the 
plans would set a bad precedent. If the government assumes the cost of 
compliance with regulatory actions which ultimately benefit the 
regulated industry, establishments will campaign for additional actions 
leading to greater government outlays. Government funded plans would 
also require an increase in the FSIS budget requiring a corresponding 
increase in taxes and also likely lead to more expensive plans. By 
bearing the costs, establishments will have a stronger incentive to 
control plan development costs than FSIS. Finally, FSIS expects that 
market forces will permit establishments to shift some of the costs to 
producers and consumers which is a more equitable allocation of costs 
than placing the burden on taxpayers in general.
    In response to comments expressing concern that each product would 
require a HACCP plan, FSIS notes that there is a major distinction 
between requiring that ``each product must be covered by the 
establishment's HACCP plan'' and requiring that ``each product have a 
unique HACCP plan.'' The final complexity of an establishment's HACCP 
plan is related to the number of distinct processes used by the 
establishment and not the number of products produced.
    e. Final Cost Estimates. Although the final rule has eliminated the 
process categories and requires a single, comprehensive HACCP plan for 
each establishment with hazards, the final cost estimates are based on 
the earlier estimates of 16,889 plans for federally inspected 
establishments and 6,120 plans for state inspected establishments. 
Since final cost is still a function of the number and complexity of 
processes, FSIS sees no reason to change the methodology for estimating 
HACCP plan development costs. Furthermore, it is reasonable to assume 
that establishments may develop their plans in segments beginning with 
relatively simple processes and then proceeding to more complex 
processes.
    The final cost estimates for 23,019 HACCP plans are shown in Table 
25. The final cost estimate for federally inspected establishments is 
based on Table 24 which presents different costs, depending on the 
sequence, for easy, moderate and difficult plans. The final cost 
estimate does not, however, assume that the first HACCP plan is 
actually the second plan because of experience gained in developing 
sanitation SOP plans and microbial sampling plans. The result is that 
the average cost for the 16,899 plans for federally inspected 
establishments is now $3,240, up from the preliminary analysis average 
of $2,020 per plan. The average cost for 6,120 plans in state inspected 
establishments is $2,000, the same per plan cost used in the 
preliminary analysis.
    It is assumed that HACCP validation is an integral part of HACCP 
plan development and that the requirement for annual reassessment will 
be a minimal cost for establishments that do not modify their products 
or processes and are not experiencing difficulty in meeting all 
critical limits. The analysis assumes that the average annual 
reassessment will take two hours per plan at a quality control 
manager's salary of $25.60 per hour. Thus, the average annual 
reassessment will cost $51.20 per plan.

                        Table 25.--Cost Of HACCP Plan Development and Annual Reassessment                       
----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                           Number       Number   Total    cost per     Annual   
                Establishment category                 establishments   plans     cost      plan    reassessment
                                                                                 ($000)  (dollars)     ($000)   
----------------------------------------------------------------------------------------------------------------
Low..................................................        2,234       5,106   17,762     3,479          261  
Medium...............................................        3,103       8,712   28,075     3,223          446  
High.................................................          849       3,081    8,911     2,892          158  
                                                      ==========================================================
      Subtotal.......................................        6,186      16,899   54,748     3,240          865  
State................................................        2,893       6,120   12,240     2,000          313  
                                                      ----------------------------------------------------------
      Total..........................................        9,079      23,019   66,988     2,910        1,179  
----------------------------------------------------------------------------------------------------------------

    As discussed above under methodology, this cost analysis assumes a 
static number of establishments and processes while recognizing that 
the rule will add to the cost of new establishments or processes. One 
such

[[Page 38984]]

cost would be the annual reassessment for establishments that add new 
processes or substantially modify existing production practices.
4. HACCP Programs--Recordkeeping Costs
    a. Summary of Requirements. The final rule requires that all 
establishments record observations when monitoring critical control 
points and document any deviations and corrective actions taken. The 
rule also requires a certification review of records by an employee not 
involved in recording observations. Such recording and certification 
review of observations at critical control points is a fundamental 
HACCP principle.
    FSIS is requiring that the records involving measurements during 
slaughter and processing, corrective actions, verification check 
results, and related activities contain the identity of the product, 
the product code or slaughter production lot, and the date the record 
was made. The purpose of this requirement is to assure that both the 
company and the regulator can readily link a record to a product and 
the timeframe in which it was processed. FSIS is also requiring that 
the information be recorded at the time that it is observed and that 
the record be signed by the operator or observer.
    FSIS is also requiring that the HACCP records be certified by a 
company employee other than the one who produced the record, before the 
product is distributed in commerce. The purpose of this review is to 
verify that the HACCP system has been in operation during the 
production of the product, that it has functioned as designed and that 
the company is taking full responsibility for the product's meeting 
applicable regulatory requirements. The employee conducting the 
certification review must sign the records.
    FSIS is also requiring that HACCP plans and records be available 
for review by program personnel. Records access is necessary to permit 
verification of all aspects of a HACCP system.
    b. Review of Preliminary Cost Estimates. In the preliminary cost 
analysis, recordkeeping cost was defined to include the time it takes 
to make observations and record the results of those observations plus 
the cost of certifying and maintaining records. Several key variables 
were involved in the estimates for HACCP recordkeeping costs for the 
preliminary RIA. First, it was established that recordkeeping costs are 
related to the number of processing lines operating simultaneously and 
not the number of HACCP plans. That is, an establishment may have 
several HACCP plans but never have more than one operating at any given 
time. To estimate recordkeeping costs it was necessary to collect data 
on the average number of production lines operating per shift. To 
estimate product lines, data was collected for a sample of low, medium 
and high volume establishments from each of the FSIS Regional Offices. 
The data on average number of simultaneous operating lines was 
collected for processing operations, red meat slaughter operations and 
poultry slaughter operations for both first and second shifts. Costs 
were then estimated based on 7,639 federal and 4,080 state inspected 
operations as shown in Table 26.

   Table 26.--Operations in Federal and State Inspected Establishments  
------------------------------------------------------------------------
                                   Federal          State               
   Manufacturing operation        inspected       inspected      Total  
                               establishments  establishments           
------------------------------------------------------------------------
Processing...................         6,006           2,752        8,758
Meat slaughter...............         1,327           1,270        2,597
Poultry slaughter............           306              58          364
                              ------------------------------------------
    Total....................         7,639           4,080       11,719
------------------------------------------------------------------------

    It was further assumed that each State establishment was a single 
shift establishment and that State establishments would have the same 
number of production lines as the first shift of a low volume federal 
establishment.
    Other variables included the average number of CCP's per plan and 
the average amount of time for recording and reviewing records per CCP. 
For federally inspected establishments, the analysis assumed that 
processing HACCP plans have an average of 7.4 CCP's and slaughter plans 
have an average of 5 CCP's. It was assumed that State inspected 
establishments will average 5 CCP's per HACCP plan. Recording time was 
estimated at an average of 5 minutes per CCP per shift. Review time for 
certification was estimated at an average of 2 minutes per CCP per 
shift. Recording cost was estimated based on an employee earning $12.87 
per hour. Certification cost was based on a supervisor or QC technician 
earning $18.13 per hour. All storage costs were based on a national 
survey of storage costs showing an average annual cost of $8.40 per 
square foot.
    Total recordkeeping costs are the sum of the costs for three 
components: Monitoring CCP's and recording findings, certifying 
records, and storing records. The following calculation for the annual 
costs of recording the findings from monitoring CCP's in State 
processing operations illustrates how the above estimates were used in 
estimating total recordkeeping costs:

Recording Costs For State Processing Operations =

(2,752 operations)  x  (1.1 average production lines)
  x  (5 minutes per CCP per day  60 minutes per hour)
  x  (5 CCP's per line)
  x  ($12.87 per hour)  x  (260 days per year)
 = Sec. 4.22 million

The total costs per establishment for recordkeeping, as estimated in 
the preliminary analysis, are summarized in Table 27. The total 
aggregate costs are shown in Table 28. The average cost per 
establishment and the total aggregate costs were reduced to account for 
the recordkeeping that already occurs in TQC, NELS and SIS 
establishments.

                           Table 27.--Summary of Recordkeeping Costs per Establishment                          
                                                    [Dollars]                                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                       Recurring
                    Establishment category                        Recording   Certifying  Maintaining    annual 
                                                                observations    records     records       cost  
----------------------------------------------------------------------------------------------------------------
Low...........................................................       2,560        1,442          28       4,030 
Medium........................................................       4,202        2,368          52       6,621 
High..........................................................      10,994        6,195          90      17,279 
State.........................................................       2,163        1,219          33       3,415 
----------------------------------------------------------------------------------------------------------------


                  Table 28.--HACCP Recordkeeping Costs                  
                              [$ Thousands]                             
------------------------------------------------------------------------
                                                  Number of      Annual 
            Establishment category             establishments    costs  
------------------------------------------------------------------------
Low..........................................         2,234        9,003
Medium.......................................         3,103       20,545
High.........................................           849       14,669
                                              ==========================
      Subtotal...............................         6,186       44,217
State........................................         2,893        9,880
      Total..................................         9,079       54,097
------------------------------------------------------------------------

    With the methodology used for estimating recordkeeping costs, it is 
also possible to look at annual recording and certification cost per 
operating line. Assuming a line runs 52 weeks, 40 hours per week, 2,080 
hours per year,

[[Page 38985]]

the average annual recordkeeping cost (excluding any storage costs) for 
a processing line in a federally inspected establishment would be 
$3,226.23 ($2,063.40 recording plus $1,162.74 certification). The 
average annual cost for a federally inspected slaughter line would be 
$2,179.88 ($1,394.25 recording plus $785.63 certification). All lines 
in State inspected establishments were assumed to have an annual cost 
of $2,179.88.
    c. Comments on the Preliminary RIA. Most of the comments referring 
to HACCP recordkeeping costs were general comments that the costs would 
be extremely burdensome. The comments did not question the methodology 
used in the preliminary analysis to estimate either recording, 
reviewing or storage costs. The comments included at least two proposed 
modifications that would substantially reduce costs. One comment 
suggested that small establishments record only deviations from the 
HACCP plan and responses to them. At one of the public hearings a 
representative from a consumer organization suggested that inspectors 
could conduct the recordkeeping in small establishments.
    d. Response to Comments. FSIS believes that while both of the above 
suggestions would reduce cost, they both do damage to the concept of 
HACCP. Having the industry take ownership and responsibility of the 
production process is a key component of HACCP. Having inspectors 
conduct the recordkeeping would severely detract from ownership. 
Furthermore, a fundamental HACCP principle requires that observations 
be recorded and reviewed at critical points in the manufacturing 
process on an ongoing basis. Recording only deviations does not meet 
this principle.
    The discussion of sanitation SOP recordkeeping costs identified 
three factors that affect how one views such costs. At least two of 
those factors apply here. HACCP recordkeeping is a cost that can be 
reduced through good management and efficiency and should also decrease 
with experience. If recordkeeping can be conducted by employees working 
at a CCP location, the additional cost should be minimal. HACCP should 
also substantially reduce the time establishment officials currently 
spend interacting with or responding to inspection findings. In 
addition to responding to the approximately 700,000 to 800,000 
Processing Deficiency Records (PDRs) per year, establishments have 
thousands of meetings with program officials following reviews 
conducted by area and regional officials or reviewers from the Program 
Review Division in Lawrence, Kansas. FSIS believes strongly that 
establishment officials will find some recordkeeping time from reducing 
inspection interaction time.
    e. Final Cost Estimates. After considering the comments, FSIS does 
not see a need to adjust the costs estimates shown in Tables 27 and 28. 
The final aggregate cost estimates for recordkeeping are those shown in 
Table 28.
5. HACCP Programs-Training Costs
    a. Summary of Requirements. The final rule requiring that each 
establishment have access to a HACCP-trained individual remains 
identical to the training requirement as proposed. The final rule does 
not, however, include the proposed requirement that the name and resume 
of the HACCP-trained individual be on file at the establishment.
    b. Review of Preliminary Cost Estimates. The proposed rule included 
the requirement that each establishment have access to a HACCP-trained 
individual. In the preliminary cost analysis FSIS pointed out that 
establishments would have options for meeting that requirement. For 
example, establishments could train an existing employee or use a 
consultant on an as-needed basis. To provide a cost estimate, FSIS 
assumed that each slaughter or processing operation would send one 
employee to a recognized HACCP course for approximately three days.
    The preliminary analysis assumed a combination establishment would 
require training for both slaughter and processing operations. The 
preliminary analysis identified 11,719 separate meat slaughter, poultry 
slaughter and processing operations. The analysis assumed that 5 
percent of these operations currently have a trained individual and 
11,133 would require training.
    Training would be a one-time, up-front expense. The cost of 
training 11,133 establishment employees at $2,514 each would be 
approximately $28 million. The $2,514 included tuition for a three-day 
course, travel expenses and wages. In estimating these costs, FSIS used 
a listing of 1994 HACCP courses compiled by the USDA Extension Service.
    c. Comments on the Preliminary RIA. Most of the comments relating 
to the cost of training industry personnel were of a general nature 
(e.g., FSIS underestimated the cost of training) or suggested that all 
training be funded by USDA. Many small processors lumped training with 
other requirements and indicated that the cost of implementing HACCP 
would force them to close. A couple of comments indicated that the 
commenter believed they would have to hire an additional HACCP-trained 
employee. Several comments noted that the training costs estimated in 
the IFSE study were far higher than the costs estimated by FSIS.
    d. Response to Comments. With respect to the comments that referred 
to the higher training costs estimated in the IFSE study, FSIS notes 
that the IFSE study assumed that training was both an up-front and a 
continuing annual expense. They also assumed that HACCP training was 
necessary for top management, supervisors and relevant hourly 
employees. Since the IFSE study was written with a beef slaughter 
establishment in mind, it is assumed that the authors believed it is 
necessary to train some or all of the employees working the dressing 
line. Under their assumptions, a high turnover would require 
substantial recurring annual costs.
    The FSIS cost estimate was tied to meeting the proposed regulatory 
requirements. The IFSE estimates are the authors' judgment of what 
would be required to ``successfully'' implement an effective HACCP 
program. The IFSE study did not provide any rationale for the cost 
estimates used. For example, the authors assumed that annual training 
costs for 5,127 small businesses would be $10,000 each for a total 
annual cost of $50 million. That estimate would appear high considering 
the large number of establishments with fewer than five employees.
    The IFSE study does raise the issue of whether a single three-day 
course for one employee is adequate to ensure an effective HACCP 
program. A low cost ongoing training program may be better. FSIS now 
plans on having training videos and/or correspondence courses available 
for each establishment. This will present an easier burden for very 
small establishments because it will not require having an employee 
leave on travel to receive training. As the number of available courses 
and locations increases, travel costs will also decrease. Trade 
associations can help provide local training for all establishments 
near large metropolitan areas.
    FSIS also recognizes that employee turnover will require some level 
of recurring cost. The necessity of training new hires should, however, 
decrease over time as the available pool of HACCP-trained individuals 
increases. FSIS will, however, include a 10 percent recurring cost in 
the final cost estimate.

[[Page 38986]]

    e. Final Cost Estimates. The final training cost estimates are 
shown in Table 29. The one-time cost of $27,988 thousand is the same 
cost as estimated for the preliminary analysis. In response to 
comments, an annual recurring cost of $2.8 million has been added.

                    Table 29.--HACCP--Training Costs                    
                              [$ Thousands]                             
------------------------------------------------------------------------
                                                               Recurring
         Establishment category          Number of   One-time    costs  
                                         employees     cost      (10%)  
------------------------------------------------------------------------
Low....................................      2,610      6,562        656
Medium.................................      3,593      9,033        903
High...................................      1,054      2,650        265
                                        --------------------------------
Subtotal...............................      7,257     18,244      1,824
State..................................      3,876      9,744        974
                                        --------------------------------
Total..................................     11,133     27,988      2,799
------------------------------------------------------------------------

6. HACCP Programs--Impact on Total Quality Control/Overtime Issues
    a. Summary of Requirements. The proposed rule did not include 
proposed revisions to existing Total Quality Control (TQC) regulations. 
However, the preamble stated that FSIS is considering having HACCP be 
the only Agency recognized health and safety related process control 
system. The preliminary RIA published with the proposed rule stated 
that: ``With the publication of the rule, TQC establishments could lose 
their authority to produce and ship product after their normal shift 
production time. As a result, 287 active TQC establishments could begin 
to incur annual overtime charges.''
    The final decisions on TQC regulations have not been made. This 
final analysis uses the impact on overtime as a conservative estimate 
of the potential impact of pending decisions.
    b. Review of Preliminary Cost Estimates. The Agency's supplemental 
cost analysis recognized that there are 287 TQC establishments that 
would incur overtime costs to continue their current operating 
schedules if the TQC regulations were eliminated. The total cost for 
these 287 establishments was estimated at $2.1 million per year. The 
preliminary analysis estimated that the total of 287 included 112 low, 
124 medium and 51 high volume producers.
    c. Comments on the Preliminary RIA. A TQC establishment commented 
that under the proposed rule they would have to pay an additional 
$32,308.80 per year in overtime charges. The establishment commented 
that these additional overtime charges would equate to a substantial 
portion of their annual net profit.
    d. Response to Comments. The comment from the TQC establishment is 
consistent with the preliminary analysis that was based on the premise 
that TQC establishments would lose their authority to produce and ship 
products after their normal shift production time. If such authority is 
withdrawn establishments would have to incur overtime charges if they 
want to continue their present operating schedules.
    The establishment estimated its potential overtime cost based on an 
assumption of 100 percent coverage. If the establishment's overtime 
hours were covered by a patrol assignment, they would be subject to the 
provisions of proportional coverage and the actual level of overtime 
charges could be substantially lower.
    Inspection assignments cover 8 hours of regular time and may also 
include scheduled overtime inspection. An assignment may specify 8 
hours in one establishment or direct the inspector to cover multiple 
establishments, i.e., a patrol assignment where the inspector would 
spend a portion of each day in each establishment. In cases where an 
inspector spends 8 hours in a single establishment and that 
establishment decides to operate for 2 hours of overtime on a routine 
basis, inspection coverage may be provided by having the assigned 
inspector work 2 hours of overtime. This type of coverage would be 
likely if the establishment was located in an isolated area. In this 
type of case, the establishment would be charged for 2 hours of 
overtime inspection each day. This type of overtime situation would 
lead to maximum costs as suggested by the commenter.
    If the establishment was part of a patrol assignment and there were 
two establishments working 2 hours of overtime, the overtime production 
could be covered by having the inspector work 2 hours of patrol 
overtime, but each establishment would only be billed for one hour, 
i.e., proportional overtime coverage.
    Because the majority of establishments are covered by patrol 
assignments, proportional coverage is employed frequently. Thus, the 
establishments' estimate of $32,308.80 is a maximum level. The actual 
level of charges could probably be substantially lower.
    e. Final Cost Estimates. This final analysis has included a cost of 
$2.1 million for annual overtime charge. The analysis has assumed that 
the additional overtime charges will occur on the same timeframe as the 
sequencing of HACCP implementation.

E. Summary of Costs for Low Volume Producers

    Because there has been particular interest in the impact of this 
rule on small business, this final section summarizes the overall costs 
for low volume producers. Table 30 illustrates the costs faced by a 
typical low volume producer over the four-year implementation period. 
Because there are less than 100 low volume poultry slaughter 
establishments, the costs for generic E. coli sampling was not included 
in Table 30. The costs illustrated in Table 30 apply to the majority of 
inspected establishments, an estimated 2,234 federally inspected 
establishments and all but a few of the 2,893 state inspected 
establishments. These 5,000-plus establishments all meet the regulatory 
flexibility definition for a very small establishment and have the full 
42 months to implement mandatory HACCP systems. There are another 658 
establishments (medium volume production) that will have slightly 
higher costs, but will also have 42 months to implement HACCP because 
they meet the regulatory flexibility criteria for a very small 
establishment. All establishments meeting the regulatory flexibility 
criteria for small establishments will have 30 months to implement 
HACCP. The 353 large establishments (more than 500 employees) will be 
required to implement HACCP 18 months after publication.

                                           Table 30.--Summary of Costs for a Typical Low Volume Establishment                                           
                                                                        [Dollars]                                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Cost category                               Year 1            Year 2            Year 3            Year 4            Year 5+    
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Sanitation SOPs Plans and Training.........................             a 190  ................  ................  ................                  
    Observation and Recording.................................             1,242             1,242             1,242             1,242             1,242
II. Compliance With Salmonella Standards......................  ................  ................  ................         b 0-1,200         b 0-1,200

[[Page 38987]]

                                                                                                                                                        
III. HACCP Plan Development...................................  ................  ................  ................       4,231-7,952                  
    Annual Plan Reassessment..................................  ................  ................  ................  ................               177
    Initial Training..........................................  ................  ................  ................     d 2,937-3,368                  
    Recurring Training........................................  ................  ................  ................  ................           294-337
    Recordkeeping.............................................  ................  ................  ................             2,015             4,030
IV. Additional Overtime.......................................  ................  ................  ................         e 0-3,702         e 0-7,404
                                                               -----------------------------------------------------------------------------------------
        Total.................................................             1,432             1,242             1,242     10,425-11,625       5,743-6,986
--------------------------------------------------------------------------------------------------------------------------------------------------------
a This cost for the 112 low volume TQC establishments would be $64.                                                                                     
b The estimate of $1,200 is based on monthly testing for two products and an antimicrobial rinse for one.                                               
c The Cost Analysis is based on estimates that low volume federally inspected establishments will require an average of 2.29 plans each, at a cost of   
  $3,479 per plan (see Table 25) for a total average plan development cost of $7,952. The number of plans for federally inspected establishments is     
  based on data from existing FSIS data bases. It was assumed that state plans have an average of 2.12 plans each for a total cost of $4,231 per        
  establishment ($2,000 per plan).                                                                                                                      
d Average training costs for state establishments ($3,368 per establishment) were estimated to be slightly higher than the average federally inspected  
  low volume establishments ($2,937 per establishment) because the state programs have a higher percentage of combination slaughter and processing      
  establishments. The cost analysis assumed that plans would train one individual for each processing, red meat slaughter and poultry slaughter         
  operation.                                                                                                                                            
e The preliminary analysis estimated that 112 of 287 active TQC establishments are low volume producers. The average TQC establishment avoids an annual 
  overtime charge of $7,404. The cost estimates in Table 30 for additional overtime costs apply only to those 112 establishments and assume that TQC    
  provisions will be phased out as HACCP is phased in--42 months after publication for the low volume establishments. Because the overtime costs apply  
  to only 112 establishments, they are not included in the Table 30 totals.                                                                             


    The average costs shown in Table 30 will be a burden for many of 
the low volume producers. However, there are factors that should help 
diminish the burden. Most of the costs and essentially all of the 
recurring costs are labor costs for monitoring sanitation procedures, 
monitoring HACCP critical control points and keeping both HACCP and 
sanitation records. As the above analysis points out, these are costs 
that can be reduced through efficient management and allocation of 
resources and should decrease with experience. The Agency also views a 
portion of these costs as a shift in resources, i.e., establishment 
management should spend more resources monitoring establishment 
operations and less time interacting with program personnel.
    Another way of illustrating costs to small businesses is to look at 
the costs for one or more specific examples. Table 31 illustrates the 
costs for a small, single-shift, processing establishment (no TQC or 
sanitation PQC program) with two distinct production operations other 
than raw ground product (overall average was estimated at 2.29 based on 
data shown in Table 25).

   Table 31.--Costs for Typical Single-Shift Processing Establishment   
                                [Dollars]                               
------------------------------------------------------------------------
                                                Development             
                                                    and        Recurring
                 Requirement                  Implementation    Annual  
                                                   costs         Costs  
------------------------------------------------------------------------
Sanitation SOP's............................           190         1,242
HACCP Plan Development......................         6,958             0
Annual Plan Reassessment....................             0           102
Training....................................         2,514           251
Recordkeeping...............................             0         6,480
                                             ---------------------------
    Total...................................         9,662         8,075
------------------------------------------------------------------------

    If one of the two production operations produced a raw ground 
product, the establishment would have to meet the pathogen reduction 
performance standard for that product. As noted earlier in the 
development of the low and high cost scenarios for meeting the new 
Salmonella standards, raw ground operations do not have the same 
opportunities to reduce Salmonella levels as do slaughter 
establishments. They can control growth by avoiding temperature abuse 
and can limit cross-contamination, but basically they must depend on 
the Salmonella levels of their incoming product in order to meet the 
performance standards. These establishments may choose to test incoming 
product in order to eliminate suppliers whose product is found to be 
positive. The final analysis has assumed that the low volume producers 
would not test incoming ingredients.
    Table 32 illustrates the costs for a small, single-shift, 
combination (slaughter and further processing) establishment that 
slaughters cattle or swine, but not both, and has a single further 
processing operation other than raw ground product. The establishment 
is not under TQC inspection.

   Table 32.--Costs for Typical Single-Shift Combination Establishment  
                                [Dollars]                               
------------------------------------------------------------------------
                                                Development             
                                                    and        Recurring
                 Requirement                  implementation    annual  
                                                   costs         costs  
------------------------------------------------------------------------
Sanitation SOP's............................           190         1,242
Compliance with Salmonella Standards........             0           800
E. coli Sampling............................         1,043           653
HACCP Plan Development......................         6,958             0
Annual Plan Reassessment....................             0           102
Training....................................         5,028           503
Recordkeeping...............................             0         5,434
                                             ---------------------------
    Total...................................        13,219         8,734
------------------------------------------------------------------------

    The cost of meeting the pathogen reduction performance standards 
assumes that the establishment will use a hot water antimicrobial rinse 
and have one sample per month analyzed at an outside laboratory ($33.35 
per sample-$400 per year). The average number of head slaughtered in a 
low volume establishment is approximately 5,000

[[Page 38988]]

annually. The annual cost for the rinse is $400.
    The development costs for E. coli sampling in the small 
establishment includes $640 for developing a sampling plan and $403 to 
train an individual to conduct aseptic sampling. The recurring costs 
are based on the assumption that an average low volume slaughter 
establishment will have to complete two sampling windows (26 samples) 
before they demonstrate compliance with established criteria.
    The cost of HACCP training has doubled for the combination 
establishment because the FRIA assumed that slaughter and processing 
operations are significantly different, so that the establishment must 
either train two employees or send one employee to two separate 
training courses.
    The HACCP recordkeeping costs (monitoring CCP's and recording 
findings, reviewing records and storing records) in the above two 
examples assume that the establishments are operating each process 
continuously over a standard 52-week, 260-day, 2,080-hour work year. 
Data collected during the preliminary analysis indicates that many low 
volume establishments frequently have only a single production line 
operating at a given time. As shown in Tables 27 and 30, the final 
analysis estimates an average annual cost for HACCP recordkeeping of 
$4,030 for low volume establishments.

Appendix A to Final Regulatory Impact Assessment

Response to Comments Related to the Preliminary Regulatory Impact 
Analysis But Not Addressed Directly in the Text of the Final Analysis

    1. A comment noting that the ``data in Tables 1 and 2, (60 FR 6781) 
for Toxoplasma gondii are confusing or in error'' is correct. The 
tables as published contained typographical errors that have been 
corrected for this analysis. The number of cases of foodborne illness 
from toxoplasmosis should be 2,056 cases, not 3,056 cases. The total 
number of cases from the foodborne illnesses considered also needs to 
be adjusted to correct for the above typographical error. Specifically, 
the total number of cases should be 3,605,582 to 7,132,823, and not 
3,606,582 to 7,133,823.
    2. The same comment questioned whether it is true that the 
``estimated medical costs for the 2,056 cases (toxoplasmosis) and 41 
deaths is $2,7000,000,000?'' This estimate is correct but these costs 
include the estimated costs of lost productivity and costs of 
residential care as well as the estimated medical costs of 
toxoplasmosis.
    3. There were several comments that indicated that while attempting 
to reduce the overall public health risk, the Agency could be 
increasing the risk to farmers and small producers that now have 
livestock custom-slaughtered at inspected establishments. If a large 
number of these small diverse businesses go under, the comments 
predicted an increase in at- home slaughter under very marginal 
conditions. These comments imply at-home slaughter is a high risk 
practice using terms such as barn yard butchering or shade tree 
butchering or back shed butchering.
    Changes in the final rule should allow most small businesses to 
continue to operate successfully under inspection. There are some small 
businesses that are currently primarily custom-exempt/retail exempt 
operations that may choose to withdraw from inspection. These types of 
facilities will still be available for their custom slaughtering 
services.
    4. A comment referred to the FSIS assertion that consideration of 
the costs of the various alternatives under examination is not relevant 
because the alternatives do not meet the Agency's goal of achieving the 
maximum pathogen reduction possible. The commenter concluded that this 
is an entirely inappropriate analytical framework for the examination 
of regulatory alternatives. By starting from the assumption that only 
the maximum benefit attainable will suffice, FSIS effectively renders 
its consideration of available regulatory alternatives a complete sham. 
The purpose of a regulatory impact assessment should be to examine both 
the benefits and the costs attributable to each available alternative, 
and to consider whether there is an alternative to the Agency proposal 
that is a more cost-effective means of addressing the problem at hand.
    5. One commenter stated that the Agency must include the costs 
attributable to the retained requirements as well. These retained costs 
will significantly increase the operational costs of the combined, 
layered system. FSIS does not agree that the RIA needs to include the 
cost of existing requirements.
    6. Comments expressed concern that the proposed rule was an 
experiment to collect the data needed to determine whether it was a 
good idea. These comments stated that industry should not bear the cost 
of a government research project. FSIS has clearly stated the public 
health objective of this rule.
    7. There are several comments that referred to a study conducted by 
the Research Triangle Institute for FSIS. In that study, HACCP Pilot 
Programs Cost Findings, August 31, 1994, RTI collected cost information 
during personal interviews at all nine establishments that had 
participated in USDA's HACCP Model Pilot Program.
    One comment noted that the pilot establishments used for the study 
are establishments that are larger than most of the establishments that 
are going to be affected. The RTI study noted that none of the 
voluntary participants have annual sales under $3 million. The RTI 
study was one source of information for the FSIS cost analysis. The 
Agency did not use the information in a way that suggested it was 
representative of all establishments or in any way imply that it was.
    Another comment stated that USDA relied very heavily on the nine 
pilot establishment studies. The data collected by RTI was one source 
of information used for the preliminary cost analysis. The analysis 
clearly cites the RTI study as one of several data sources.
    A comment during the public hearing attributed a cost of $23,000 or 
$27,000 to the RTI study for a hazard analysis, plan development and 
validation for a small business that doesn't need any equipment or 
establishment upgrade. The RTI study reported costs for plan 
development ranging from $607 to $15,750. FSIS assumes that the hazard 
analysis is part of plan development. The RTI study did not address a 
separate cost component for validation.
    8. One comment indicated that the source of the estimates for total 
cases and deaths for E. coli O157:H7 does not support the number used 
in the benefit estimates. The preliminary analysis was based on 10,000-
20,000 total cases and an estimate of from 200-500 total deaths. 
Sources identified were the AGA conference and CDC communications. The 
``CDC comm.'' citation mentioned in the FSIS proposal refers to both 
the Ostroff et al. (1989) and the McDonald et al. (1988) articles as 
described in the comment. These references provide an incidence rate 
for E. coli O157:H7 of 2.1/100,000 to 8/100,000. The AGA conference 
suggests there are 10,000 to 20,000 cases of E. coli O157:H7 each year 
in the United States. This translates to a rate of approximately 4/
100,000 to 8/100,000, which is higher on the lower estimate. ERS chose 
to use the consensus numbers because they reflect the current thinking 
of a nonadvocate panel of experts. FSIS agrees with the commenter that 
better data on

[[Page 38989]]

foodborne disease incidence is needed but believe that the preliminary 
analysis used the best estimates available.
    9. Commenter stated FSIS relied on faulty data. FSIS responds that 
there is a difference between saying data are limited and saying data 
are faulty. Existing food safety data are limited and more thorough 
data may not be available for a long time.
    10. A commenter noted that FSIS did not address the ``cost'' of the 
development of a highly susceptible population because some exposure is 
necessary to establish immunity. The same commenter suggested there 
might be a ``nutritional health'' cost penalty, i.e., the rule would 
increase the cost of food so much that consumers would not be able to 
afford nutritional food. FSIS notes that the commenter did not provide 
support for these ``costs.''
    11. A commenter noted that their low annual insurance premium of 
$150 strongly suggests that the insurance industry considers their 
existing safety record commendable and worthy of a low liability rate. 
FSIS notes that another comment has suggested that lower rates are 
being offered in conjunction with improved process control systems.

[FR Doc. 96-17837 Filed 7-18-96; 8:45 am]
BILLING CODE 3410-DM-P