federal register

38805

Thursday

July 25, 1996

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
38806 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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/suldocs/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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 sciencebased 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;
38808 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

(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-andtemperature 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-andcontrol 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-controlbased 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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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)
38810 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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-totable 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 issuefocused 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 postprocessing 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-totable 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 HACCPbased 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
38812 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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-andtemperature 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 (21⁄2 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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
38814 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 nonshelfstable 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 § 417.2(a); the elements of a

HACCP plan in § 417.2 (b) and (c); the

corrective action requirements in

§ 417.3; the validation, verification, and

reassessment requirements in § 417.4;

and the record review and maintenance
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38815

requirements in § 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
38816 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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-andcontrol 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
38818 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 commandand-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 afterthe-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 HACCPoriented 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-bycarcass 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-bycarcass 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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-byprocess 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 ‘‘offthe-shelf’’ HACCP training programs

prepared by private or industrysponsored 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
38820 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 establishmentspecific 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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-today 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 costbenefit 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-andtemperature 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
38822 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 safetyrelated 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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 § 304.3 and a new § 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 § 326.7(a)(2) and

§ 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

§§ 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 preproduction 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 §§ 326.1 and 381.601 have

been combined, streamlined, and

redesignated as § 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 § 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
38824 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 §§ 326.2 and

381.602, ‘‘Development of HACCP

Plan,’’ §§ 326.3 and 381.603, ‘‘HACCP

Principles,’’ and §§ 326.4 and 381.604,

‘‘Implementation of the HACCP Plan.’’

These provisions have been modified

and incorporated into § 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

§§ 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 § 326.3(a),

(a)(1), and (a)(2), and § 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 § 417.2(a)(2).

Proposed §§ 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

§ 417.7. The new § 417.2(a)(1) permits

someone other than an establishment

employee to conduct the hazard

analysis.

Proposed §§ 326.3(a) and 381.603(a)

would have required a hazard analysis

to identify any biological (including

microbiological), physical, or chemical

hazards. In § 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 §§ 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

§ 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 §§ 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 §§ 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 §§ 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38825

provisions were unnecessary, FSIS has

set forth in § 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 § 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

§ 326.3(b) and 381.603(b)), this

requirement has been removed from the

final rule.

Proposed §§ 326.4 and 381.604 would

have required that a responsible

establishment official, formerly defined

as ‘‘the management official located onsite 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 § 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 § 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 §§ 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 pathogenfree 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 § 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

(§§ 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,

§ 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 §§ 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

§§ 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
38826 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 § 417.4

and FSIS’s verification procedures are

presented in § 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) HACCPtrained 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

§ 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 wellestablished, 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-today 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 pathogenspecific 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, inplant 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 processmonitoring 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, § 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 processmonitoring 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

(§ 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

§ 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
38828 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 § 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 nontargeted, 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 §§ 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 § 417.8.

Records

Proposed §§ 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 § 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 § 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 § 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 § 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 § 417.5 (a)(1) and (a)(2),

however, are not eligible for off-site

storage.

Proposed §§ 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 § 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 § 417.2(b);

• Reassessment and modification of

the HACCP plan as required by § 417.3

and/or § 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

§ 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 §§ 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.
38830 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 preoperational 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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.
38832 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

§ 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, § 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.
38834 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 preoperational 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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 processcontrol 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
38836 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 longterm 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 issuefocused 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, issuefocused 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
38838 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38839

1Expert Panel’s Summary Report and

Recommendations, Scientific and Technical

Conference on Role of Microbiological Testing in

Verifying Food Safety, May 1–2, 1995.

2Subcommittee 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.

3Food 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.

4Food 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.

E. coli, the potential presence of enteric

pathogens will be minimized.1

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.

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 recontamination. 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 nonsampling 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

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 animalderived 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
38840 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

surveys for each species of livestock and

poultry.

The E. coli performance criteria are

expressed in terms of a statistical

procedure known as a ‘‘3-class attributes

sampling plan’’ applied in a moving

window. This procedure specifies

cutoffs (denoted m and M, with m<M)

for quantitative E. coli levels so as to

define three classes of results:

acceptable, marginal, and unacceptable.

The definitions are:

Acceptable—result ≤ 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 industrydeveloped 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 workforce, often supervised by an owneroperator, 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 volumebased 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
38842 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

5Bean, N.H. and P.M. Griffin. 1990. Foodborne

Disease Outbreaks in the United States, 1973–1987.

J. Food Protection. 53:804–817.

6Centers 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.

7Tauxe, 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.

8Ostroff, S.M., J.M. Kobayshi, and J.H. Lewis.

1989. Infections with Escherichia coli O157:H7 in

Washington State. JAMA 262(3):355–359.

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.

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 caseby-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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38843

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.

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.

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
38844 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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
38846 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

Class of product

Performance

standard (percent positive

for Salmonella)

(%)

Number of

samples

tested

(n)

Maximum

number of

positives to

achieve

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
38848 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 preimplementation phase will begin

approximately three months after

publication of the final rule and initially

will consist of an establishment-byestablishment 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 preimplementation 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 twopart testing program mentioned above:

the ongoing testing, which will include

all establishments at some fixed

interval, irrespective of performance;
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 HACCPbased 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
38850 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 selfenforcing. 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, readyto-eat items, while others stated that

exemptions for these items would be

inappropriate.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 FSISconducted 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 precedentsetting, 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.
38852 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38853

11American National Standard ANSI Z1.1–1985.

‘‘Guide for Quality Control Charts.’’ American

Society for Quality Control. Milwaukee, WI.

‘‘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 noncompliance, 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.

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 nondestructive 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
38854 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

12National Advisory Committee on

Microbiological Criteria for Foods. 1994. ‘‘Hazard

Analysis and Critical Control Point Systems.’’ FSIS,

USDA.

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 endproduct 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.

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 radiationemitting electronic devices such as xrays 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 longstanding 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 postchill, 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.
38856 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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°F (10°C) within 5 hours and

then to 40°F (4.4°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 (§ 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°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°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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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°F

would provide a large margin of safety

against the multiplication of pathogenic

bacteria, which generally will not

multiply at temperatures below 50°F. It

is similar to the maximum temperature

of 40°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°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 systemimplementation 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-ofentry 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 twothirds 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
38858 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 §§ 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 (§ 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 HACCPbased 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 timeand-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 Standards ................................................................... Not Separately Estimatedc 55.5–243.5

Compliance with generic E. coli criteria ................................................................. Not Applicable .................... Not Separately Estimated

VI. HACCP

Plan Development ................................................................................................... 35.7 .................................... 54.8

Annual Plan Reassessment .................................................................................... 0.0 ...................................... 8.9

Recordkeeping (Recording, Reviewing and Storing Data) ..................................... 456.4 .................................. 440.5d

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

aThe 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. bThe 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. cThe 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. dThese costs are slightly different from the proposal because of changes in the implementation schedule.

eFSIS added costs for recurring training based on the review of public comments.

fBased on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP verification testing.
38860 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 selfpolicing 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 costeffective, 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 costeffective 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 FederalState-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
38862 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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]

Requirement

Development and

implementation costs

Recurring

annual

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 crosscontamination, 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]

Requirement

Development and

implementation costs

Recurring

annual

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

Review of the records generated is

estimated to take 5, 10, and 20 minutes

per day for a low-, medium-, and highvolume 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 HACCPtrained 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

Requirement

Burden hours

approved by

OMB

New burden

hours

Reduction in

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
38864 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

1A 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.

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:

§ 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 §§ 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 § 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 § 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:

§ 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 § 310.25 to read as follows:

§ 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

(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 § 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38865

2A 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.

3A 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.

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.

(4) Recording of test results. The

establishment shall maintain accurate

records of all test results, in terms of

cfu/cm2 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

Slaughter class Lower limit of marginal range

Upper limit of marginal range

Number of

samples

tested

Maximum

number permitted in

marginal

range

(m) (M) (n) (c)

Steers/heifers .................................................................................... Negative a .................. 100 cfu/cm2 ............... 13 3

Cows/bulls ........................................................................................ Negative a .................. 100 cfu/cm2 ............... 13 3

Market hogs ...................................................................................... 10 cfu/cm2 ................. 10,000 cfu/cm2 .......... 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/cm2 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

Class of product

Performance Standard (percent

positive for

Salmonella)a

Number of

samples

tested

(n)

Maximum

number of

positives to

achieve

Standard

(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.

aPerformance 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) Noncompliance and establishment

response. When FSIS determines that an
38866 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

1A 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.

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:

§ 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).

§ 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 § 381.22 is added to

subpart D to read as follows:

§ 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 §§ 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 § 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 § 417.4 of this chapter.

Subpart H—Sanitation

13. Section 381.45 is amended to read

as follows:

§ 381.45 Minimum standards for

sanitation, facilities, and operating

procedures in official establishments.

The provisions of §§ 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:

§ 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

(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 § 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38867

2A 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.

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.

(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

Slaughter class

Lower limit of

marginal range

(m)

Upper limit of

marginal range

(M)

Number of sample

tested

(n)

Maximum number

permitted in marginal range

(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

Class of product

Performance

Standard (percent

positive for Salmonella) a

Number of samples tested

(n)

Maximum number

of positives to

achieve Standard

(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.

aPerformance 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.) bStandard 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.
38868 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

3A 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.

(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) 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:

§ 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).

§ 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.

§ 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.

§ 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).

§ 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.

§ 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.

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

§ 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.

§ 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.

§ 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.

§ 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.
38870 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

(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 § 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 § 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

§ 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.

§ 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 § 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

§ 417.4(a)(2)(iii) and the recordkeeping

requirements of § 417.5 of this part.

§ 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 processmonitoring instruments;

(ii) Direct observations of monitoring

activities and corrective actions; and

(iii) The review of records generated

and maintained in accordance with

§ 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 § 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

§ 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.

§ 417.5 Records.

(a) The establishment shall maintain

the following records documenting the

establishment’s HACCP plan:

(1) The written hazard analysis

prescribed in § 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 § 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 shelfstable 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.

§ 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 § 417.3

of this part;

(d) HACCP records are not being

maintained as required in § 417.5 of this

part; or

(e) Adulterated product is produced

or shipped.

§ 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 § 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

§ 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.

§ 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 longterm 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
38872 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

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
38874 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

necessary during the dressing

procedures.

b. Employees will clean and then

sanitize with 180° 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° 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° 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°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° 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.
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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?
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For example, a cooked sausage could

be called franks/hot dogs/wieners.

2. How is it to be used?

Categories might include: Ready-toeat, 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°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.
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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, crosscontamination 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 crosscontamination.

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.
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• 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 noncomplying product;

2. Correcting the cause of the noncompliance 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
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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 onsite 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 scientificallybased 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.

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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. llllllllllllllllllllllllllllllllllllllllllllllllllllll

PRODUCT/PROCESS lllllllllllllllllllllllllllllllllllllllllllllllllllllll

DATE llllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll

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?
38904 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

HACCP PLAN CHECKLIST—Continued

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

Pathogens Temperature

of growth pH Minimum Aw

Bacillus cereus ............................................................................................................................. 10–48 °C 4.9–9.3 0.95

Campylobacter jejuni .................................................................................................................... 30–47 °C 6.5–7.5 ........................

Clostridium botulinum ................................................................................................................... 3.3–46 °C >4.6 0.94

(Types A,B,E) ............................................................................................................................... ........................ ........................ ........................

Clostridium perfringens ................................................................................................................ 15–50 °C 5.5–8.0 0.95

Escherichia coli O157:H7 ............................................................................................................. 10–42 °C 4.5–9.0 ........................

Listeria monocytogenes ............................................................................................................... 2.5–44 °C 5.2–9.6 ........................

Salmonella .................................................................................................................................... 5–46 °C ........................ 4–9 0.94

Staphylococcus aureus ................................................................................................................ 6.5–46 °C 5.2–9 0.86

Yersinis enterocolitica .................................................................................................................. 2–45 °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,
38906 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 crosscontamination 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, cleaning compounds, etc ......... Supplier’s HACCP plan; use of specifications, letters of guarantee;

vendor inspections and certification; in-house inspections of materials.

Foreign objects introduced by processing operations or employee practices.In-line metal detectors; visual product examinations; proper maintenance of equipment; frequent equipment inspections.
38908 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 7.—SOME EXAMPLES OF REGULATORY LIMITS

Hazard Regulatory limit Regulatory

citation

biological: Microbial growth due to temperature abuse-Poultry

Chilling.

All poultry must be chilled immediately after processing to a

temperature of 40 °F or less.

§ 381.66

chemical: Excess chemicals contact product ............................... Chemicals used are approved for the intended use and at appropriate amounts.§ 318.7

chemical: Chemical hazard from packaging materials ................. Edible products must be packaged in container that will not

adulterate product or be injurious to health. Packaging materials must be covered by a letter of guaranty.

§ 317.24

biological: Trichinae in pork .......................................................... Products containing pork muscle tissue must be effectively

heated, refrigerated, or cured to destroy any possible live

trichinae.

§ 318.10

biological: Pathogens in ready to eat products ............................ For destruction of pathogens that may survive a dry heat process. One of the time/temperature combinations for cooked

beef, roast beef, and cooked corned beef; e.g., 143 °F\61.7

°C minimum temperature at minimum time of 6 minutes.

§ 318.17

physical: Extraneous material found on post chill examination of

poultry carcasses.

Sampled carcasses observed for conformance with post chill

criteria, including unidentified foreign material.

§ 381.76

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

Red meat slaughter-beef: examples of

processing steps B C P Description of biological, chemical, orphysical hazards for the process steps Controls or preventive measures

Receiving & Holding .................................. X —Residues present in edible tissues

above tolerances.

—Residue certification presented for live

animal(s).

Skinning ..................................................... X —Micro contamination of carcass surface

due to contaminated outside hide surface—contamination of carcass from

floor—cross-contamination.

—Skinning procedures are accomplished

without hair or visible fecal contamination of the carcass.—Careful employee

practices.—Udder and puzzle removal

are accomplished without contamination of edible product.

Evisceration ................................................ X —cross-contamination from broken

viscera.

—Esophagus is tied to 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 through insufficient wash.—Final wash: Temperature: 90–100°F

Pressure: 345–2070 kpa (50–300

psi)—Steam Pasteurization: Temperature: 195°F or greater at surface Dwell

time: 5–15 seconds in cabinet.

Chilling ....................................................... X —growth of pathogens ............................. —Surface temperature ≤40°F as soon as

possible—Carcasses spaced a minimum of 1 inch apart.

Receiving-Packaging Materials and Non

Beef Supplies.

X —contamination from deletious chemicals

present in the packaging materials.

Letters of guarantee on file for all packaging materials/non-poultry supplies

used by the establishment.

Storage-Non Beef Supplies ....................... X —contamination of stored packing materials/supplies from foreign material.Examine to ensure no visible foreign material on/in non-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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38909

TABLE 9.—POULTRY SLAUGHTER

Poultry slaughter: examples of processing

steps B C P Description of biological, chemical, orphysical hazards for the process steps Controls or preventive measures

Scalding ..................................................... X —contamination from scalding medium ... —Fresh water input to achieve a minimum of 1 quart per bird

—Temperature of the scald water maintained at appropriate levels (e.g.,

≥126°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 intestinal

contents/exudate.

Follow approved offline 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°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 material ..... Product entering (prechill) 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 § 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°F

within 2 hours from removal from other

viscera/fresh water intake not less than

1 gallon per 40 frying chickens processed-9 CFR § 381.66 (c)(5)].

X —contamination from foreign material ..... —Visually free of hazardous 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 materialsMPI Regulations 381.76).
38910 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 9.—POULTRY SLAUGHTER—Continued

Poultry slaughter: examples of processing

steps B C P Description of biological, chemical, orphysical hazards for the process steps Controls or preventive measures

Cut-Up/Boning/Packaging/ Labeling .......... X —growth of pathogens ............................. Temperature of product does not exceed

55°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°F.

—Packaging/labeling materials that come

into direct contact with product are intact.

Receiving-Packaging Materials and Non

Poultry Supplies.

X —contamination from deleterious chemicals present in the packaging materials.Letters of guarantee are on file for all

packaging materials/non-poultry supplies used by the establishment.

Storage-Non Poultry Supplies ................... X —contamination of stored packing materials/supplies from foreign material.Examine to ensure no visible foreign material on/in non- 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

Red meat slaughter-swine: Examples of

processing steps B C P Description of biological, chemical, orphysical hazards for the process steps Controls or preventive measures

Scalding ..................................................... X X —contamination from scalding medium ... Plant time/temperature limits for scalding

(e.g., although it may vary with facilities, a temperature of 138 to 140°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 chemicals. .............. —USDA-FDA approved chemical concentration not to exceed manufacturer’s recommendations.

Dehairing .................................................... X .... .... —contamination and growth of microorganisms due to breaking of the skin

from overexposure to the dehairer.

—Time/temperature determined by plantspecific testing results to remove visible hair to an acceptable level without

breaking skin.

Evisceration ................................................ X .... .... —cross contamination from equipment/

utensils.

—contamination from stomach, intestines, and/or bladder contents.

—contamination from employee handling

—Remove all viscera intact.

—Contaminated equipment will be clean

and sanitized before being used again.

—Training program for all employees, to

include personal hygiene, product handling procedures, and sanitary dressing

procedures.

Trimming .................................................... X .... .... Stick wound has not been removed. ........ Remove all visible stick-wound related

defects.

Chilling ....................................................... X .... .... —growth of pathogens ............................. —Cool surface temperature to 40° as

soon as possible.

Receiving-Packaging Materials and Non

Swine Supplies.

.... X .... —contamination from deleterious chemicals present in the packaging materials.Letters of guarantee are on file for all

packaging materials/non-poultry supplies used by the establishment.

Storage-Non Swine Supplies ..................... .... X —contamination of stored packing materials/supplies from foreign material.Examine to ensure no visible foreign material on/in non-poultry supplies or

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

Examples of ingredient B C P Description of biological, chemical, or

physical hazard for the ingredient Controls or preventive measures

Acidifiers ..................................................... .... X .... —toxicological effects if limits are exceeded.—Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Anticoagulants ............................................ .... X .... —toxicological effect if limits are exceeded.—Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Antifoaming agents .................................... .... X .... —toxicological effect if limits are exceeded.—Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on

producer/ provider ingredient specifications.

Antioxidants ................................................ .... X .... —toxicological effect if limits are exceeded.—Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Batter/Breading .......................................... X .... X —growth of pathogens due to improper

storage and handling.

—foreign material

—Temperature controls for use

—Ingredient specification 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 improper

storage and handling.

—Product temperature must be 40 degrees F or less at 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 limits exceeded ... —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on

producer/ provider ingredient specifications.

Blood .......................................................... X .... .... —growth of pathogens from improper

handling and storage.

—Ingredient specification sheet identifying the 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 improper

handling and storage.

—foreign particle contamination, e.g.,

metal fragments or bone.

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

—Visual examination of product for foreign materials.
38912 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 11.—INGREDIENT HAZARDS—Continued

Examples of ingredient B C P Description of biological, chemical, or

physical hazard for the ingredient Controls or preventive measures

Cooked beef ............................................... X .... X —growth of pathogens due to improper

handling and storage.

—foreign particle contamination, e.g.,

metal fragments or bone particles in

boneless beef.

—Receiving temperature of product must

be frozen or refrigerated at 40 degrees

F or below.

—Product must be received from an approved supplier 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 improper

handling and storage.

—foreign particle contamination, e.g.,

bone particles in boneless poultry.

—Receiving temperature of product must

be frozen or refrigerated at 40 degrees

F or below.

—Product must be received from an approved supplier who produces the

product under a HACCP plan.

—Product must be organoleptically acceptable at receipt.

Cooked pork ............................................... X .... X —growth of pathogens due to improper

handling and storage.

—foreign particle contamination, e.g.,

bone particles in boneless pork.

—Receiving temperature of product must

be frozen or refrigerated at 40 degrees

F or below.

—Product must be received 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 limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Coloring agents (artificial) .......................... .... X .... —Toxicological effect if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Curing agents ............................................. .... X .... —Toxico logical effect if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Curing accelerators .................................... .... X .... —-toxicological effect if limits are exceeded.—Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Dairy products ............................................ X .... X —growth of pathogens due to improper

handling and storage.

—foreign material

—Temperature control.

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

—Where applicable, ingredients must be

pathogen-free.

Eggs or egg products ................................ X .... X —growth of pathogens due to improper

handling and storage.

—foreign particle contamination, e.g.,

shell particles in broken eggs.

—Temperature control.

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

—Where applicable, ingredients must be

pathogen-free.

Emulsifying agents ..................................... .... X .... —toxicological effects if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Flavoring agents ........................................ .... X .... —toxicological effects if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Fruits .......................................................... .... X X —contamination from agricultural chemicals.

—foreign material

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

Honey ......................................................... X .... X —contamination from inherent microorganisms.

—foreign particle contamination, e.g., dirt,

insect parts.

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

Legumes (dry) ............................................ .... .... X —foreign particle contamination, e.g.,

rocks.

—Ingredient specification sheet identifying the required parameters the ingredient must meet.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38913

TABLE 11.—INGREDIENT HAZARDS—Continued

Examples of ingredient B C P Description of biological, chemical, or

physical hazard for the ingredient Controls or preventive measures

Mechanically deboned product .................. X .... X —growth of pathogens due to improper

handling and storage.

—foreign particle contamination, e.g.,

bone particles.

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

Mold inhibitors ............................................ .... X .... —toxicological effect if improper amounts

used.

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

Mushrooms ................................................ X X X —contamination from inherent microorganisms.

—contamination from agricultural chemicals.

—foreign material

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

—Where applicable, ingredients must be

pathogen-free.

Nuts ............................................................ X X X —contamination from inherent microorganisms.

—contamination from agricultural chemicals.

—foreign particle contamination, e.g.,

broken shells.

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

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 limits are exceeded.—Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Poultry (fresh, frozen) ................................ X .... .... —growth of pathogens due to improper

handling and storage.

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

Pork (fresh, frozen) .................................... X .... .... —growth of pathogens due to improper

handling and storage.

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

Proteolytic enzymes—Aspergillus oryzae,

Aspergillus, Flavusoryzae group, Bromelin, Ficin, Papain.

.... .... .... —toxicological effects if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Partially defatted products ......................... X .... X —growth of pathogens due to improper

handling and storage.

—foreign particle contamination, e.g.,

metal, plastic.

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

Seafood (fresh, frozen) .............................. X X .... —growth of pathogens due to improper

handling and storage.

—environmental contamination ................

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

Spices/herbs—Sterilized, Unsterilized ....... X .... .... —contamination from microorganisms inherent to the ingredient.

—contamination from agricultural chemicals.

—foreign material

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

Sweeteners—Saccharin, Citric acid, Malic

acid, Monoisopropyl citrate, Phosphoric

acid, Monoglyceride citrate.

.... .... .... —toxicological effects if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.
38914 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 11.—INGREDIENT HAZARDS—Continued

Examples of ingredient B C P Description of biological, chemical, or

physical hazard for the ingredient Controls or preventive measures

Tenderizing agents .................................... .... X .... —toxicological effects if limits exceeded —Ingredients purchased under a Letter

of Guarantee.

—Ingredients purchased based on producer/provider ingredient specifications.

Variety meats ............................................. X .... .... —growth of pathogens due to improper

handling, storage, or cleaning.

—Product temperature must be 40 degrees F or less at receiving.

—Product must meet establishment purchase specifications.

—Product must be produced under a

HACCP plan.

Vegetables ................................................. X X X —growth of pathogens due to improper

handling and storage.

—contamination from agricultural chemicals.

—foreign material

—Ingredient specification sheet identifying the required parameters the ingredient must meet.

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

Processing steps B C P Description of biological, chemical, or

physical hazards for the process steps Controls or preventive measures

Acidifying (also see Pickling, Brining) ........ X .... .... —survival of pathogens due to final

pH>4.6.

—Shelf-stable non-heat treated acidified

product must obtain a pH of 4.6 or

lower.

Aging (Meats) ............................................. X .... .... —growth/survival of pathogens from inappropriate storage temperatures and humidity (inadequate product water activity (aw)).

—growth of pathogens due to rise in the

pH due to development of surface

molds.

—The temperature of the aging room will

not exceed 40 degrees Fahrenheit.

—Product temperature does not exceed

40 degrees Fahrenheit throughout the

aging process.

—The aging process will not exceed

seven days.

Boning ........................................................ X .... .... —contamination by pathogens in product

accumulations (e.g., cutting boards,

conveyor belts, utensils and other

equipment).

—cross-contamination of product by

equipment/utensils contaminated with

pathogens when cutting through a nonapparent lesion (e.g., abscesses).

—Careful employee practices to make

sure that there is no contamination of

the product.

—Equipment and utensils are washed

and sanitized immediately when contaminated and each time the employee

leaves the working station.

—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, cartilage/extraneous material.—A boneless beef re-inspection procedure will be established using specifications outlined by FSIS.

Cooling ....................................................... X .... .... —growth of pathogens due to improper

temperatures.

—germination of spore-forming pathogens due to slow chilling (e.g., C.

perfringens).

Cooked product will be cooled according

to established procedures.

Cooking ...................................................... X .... .... —survival of pathogens due to improper

procedures.

—Time/Temperature combinations are

adequate to destroy the pathogens of

concern.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38915

TABLE 12.—PROCESSING STEP HAZARDS—Continued

Processing steps B C P Description of biological, chemical, or

physical hazards for the process steps Controls or preventive measures

Drying (Meat) ............................................. X .... .... —bacterial growth due to inadequate

control over time, temperature and humidity.

—A water activity will be specified that in

conjunction with other 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 pathogens in product accumulations.

—growth of pathogens due to temperature abuse.

—Product will be protected from contamination during the filling process, and

product temperature/ time will be maintained at or below the maximum determined to inhibit growth of pathogenic

microorganisms.

.... X .... —contamination from lubricants ............... —No lubricants or other chemical contaminants will be allowed in or on the

product.

Formulation ................................................ X .... .... —contamination by employee handling ...

—incorrect formulation

—contamination through damaged packages.

—Careful employee practices used at all

times to make sure that there is no

contamination of product.

—Ingredient packages will be clean and

intact.

—Ingredients will be added to product

according to requirements outlined

9CR § 318.7.

.... X .... —excessive addition of restricted

ingredients/ additives could be toxic to

the consumer.

—Restricted ingredients will be added to

product according to requirements outlined in the 9CFR § 317.8.

Freezing (Meats) ........................................ X .... .... —survival of parasites due to improper

time/temperature application.

—growth of pathogens due to temperature abuse.

—Rapid cooling and freezing.

Grinding ...................................................... X .... .... —contamination by employee handling ...

—recontamination by pathogens in product accumulations.

—Careful employee practices to make

sure that there is no contamination of

product.

—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 lubricants ............... —Food grade lubricants will be used on

areas of the machinery where a potential for product contamination exists.

.... .... X —contamination from extraneous material —All boneless product will be re-inspected before being loaded into the

grinder.

Handling and Inspecting of Empty Containers and Packaging Materials.X X X —recontamination through damaged or

soiled containers/packaging material.

—Packaging materials and empty containers will be protected from 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, cartilage

fragments.

—contamination from extraneous material

—The finished product will meet the

standards outlined in 9CFR 319.5 for

bone particles and calcium.

Packaging (also see Modified Atmosphere

Packaging, Vacuum Packaging Seaming, Sealing).

X X X —contamination from packaging material

—contamination through damaged containers.

—Closure and/or machine specifications

sufficient to ensure adequate barrier

formation.

.... .... X ................................................................... —No detectable foreign material will be

allowed in or on the product or immediate product containers.

Peeling ....................................................... X .... .... —contamination by pathogens in product

accumulations.

—contamination from employee handling

—Careful employee practices to make

sure that there is no contamination of

product.

—Product will not be allowed to accumulate in/on peeling equipment.

.... .... X —contamination from harmful extraneous

material.

—Peeling equipment will be maintained

in a proper operating condition. No foreign material in the finished product.
38916 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 12.—PROCESSING STEP HAZARDS—Continued

Processing steps B C P Description of biological, chemical, or

physical hazards for the process steps Controls or preventive measures

Receiving ................................................... X .... .... —contamination through damaged containers.

—growth of pathogens due to inappropriate storage conditions (temperature,

humidity).

—growth of pathogens due to temperature abuse.

—contamination from receiving equipment (pumps, hoses).

—Product must be received in sound

containers and at temperatures appropriate for the type of product.

.... X .... —cross-contamination from non-food

chemicals.

—Product must be received in sound

containers and be accompanied by a

letter of guarantee from the supplier if

such letter is not on file.

.... X .... —contamination from hazardous extraneous material (wood, nails from pallets, plastic pieces).—Product must be received in sound

containers and be accompanied by a

letter of guarantee from the supplier if

such letter is not on file.

Retorting ..................................................... X .... .... —inadequate application of scheduled

process.

—A thermal process specific 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 handling ...

—contamination by pathogens in product

accumulations.

—Careful employee practices to make

sure that there is no contamination of

product.

—Room temperature of storage coolers

will not exceed 40 degrees Fahrenheit.

.... .... X —contamination foreign material .............. —Careful employee practices to make

sure that there is no contamination of

product.

Shipping ..................................................... X .... .... —growth due to improper temperatures —Product will not be 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 hazardous extraneous material through damaged packages.—All product packages will be intact before shipping.

—All transport vehicles will be cleaned

after each use and before loading of

product.

Thawing ...................................................... X .... .... —growth of pathogens due to improper

temperatures.

—Thawing Room temperature will not exceed 50 degrees Fahrenheit.

Section VIII

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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. ‘‘HACCPEstablishing 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 offsite laboratory, the samples need to be
38918 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

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 prelabeled 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
38920 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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×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.)

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 × 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.
38922 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

Turkey Carcass Rinse Sampling

Procedure

Materials

1. 1 large sterile 3500 ml stomachertype or ziplock-type bags or equivalent,

at least 8′′ × 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′′ × 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′′ ×

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′′ × 30–36′′)

3. Incubator, 36 ± 1°C

4. Incubator/Water bath, 42 ± 0.5°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°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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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°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°C for 22–24 hours.

b. Incubate the RV enrichment culture

at 42 ± 0.5°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°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°C for 24±2 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.
38924 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

Triple sugar iron agar Lysine iron agar Polyvalent sera

Disposition

Butt Slant H 2S Butt H2S O H

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.

1Salmonella choleraesuis (rarely found in swine in U.S.). 2Salmonella 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 °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 × 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 °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

°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 °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 °C overnight, and

then store at 4–8 °C.

For long-term storage of isolates,

subculture Salmonella isolates by

stabbing nutrient agar (0.75% agar).

Incubate at 36 ± 1 °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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 °C, and then store them at 4–8 °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 RappaportVassiliadis (RV) enrichment medium for the

isolation of salmonellas: An overview. J.

Appl. Bacteriol. 54:69–76.

BILLING CODE 3410–DM–P
38926 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38927
38928 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

BILLING CODE 3410–DM–C
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38929

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 offsite 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
38930 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

slaughter volumes for very low volume

establishments are described in Table 2.

TABLE 2.—MAXIMUM YEARLY LIVESTOCK SLAUGHTER VOLUMES FOR

VERY LOW VOLUME ESTABLISHMENTS

Slaughter speciesCriteria (yearly slaughter

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 calculatoror 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 halfcarcass (carcass) for sampling. The

reason for counting back five halfcarcasses 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 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. 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 prelabeled 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 cm2 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.
38932 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

cm2. 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

cm2 of carcass surface area.

Record Keeping

Each test result must by recorded in

terms of colony forming units per square

centimeter (cfu/cm2). 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 100 cfu/cm2 ......... Above 100 cfu/cm2.

Swine .................................. 10 cfu/cm2 .......................... Above 10 cfu/cm2 but not above 10,000

cfu/cm2.

Above 10,000 cfu/cm2.

*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/cm2 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/cm2, and unacceptable if

above 100 cfu/cm2.

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.
38934 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

Test # Date

Time

collectedTest result (cfu/cm2) Result unacceptable? Result marginal?

Number

marginal

or unacceptable

in last

13

Pass/fail?

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 (xaxis), 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38935
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38938 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

BILLING CODE 3410–DM–C
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 offsite 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

Slaughter

species

Criteria (yearly slaughter 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
38940 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

numbers. Methods could include: using

random number tables, using calculatoror 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 leakproof 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′′ × 24′′. Large

turkeys should be placed in a plain,

clear polypropylene autoclave bag ,

about 24′′ × 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.
38942 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 1,000 cfu/ml Above 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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38943

Test No. Date Time

collected

Test result

(cfu/ml)

Result

unacceptable?

Result

marginal?

Number

marginal or

unacceptable in last

13

Pass/

Fail?

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
38944 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

BILLING CODE 3410–DM–C
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 31⁄2 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
38946 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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-toillness relationship is further

complicated because crosscontamination 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 crosscontamination 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 crosscontamination 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 Requirements ............................................................ 45.5 ...................................................... 0.0

III. Antimicrobial Treatments ........................................................................ 51.7 ...................................................... 0.0

IV. Micro Testing .......................................................................................... 1,396.3b ................................................ 174.1

V.

Compliance with Salmonella standards ................................................ Not Separately Estimatedc ................... 55.5–243.5

Compliance with generic E. coli criteria ............................................... Not Applicable ...................................... Not Separately Estimated

VI. HACCP:

Plan Development ................................................................................. 35.7 ...................................................... 54.8

Annual Plan Reassessment .................................................................. 0.0 ........................................................ 8.9

Recordkeeping (Recording, Reviewing and Storing Data) ................... 456.4 .................................................... 440.5d

Initial Training ........................................................................................ 24.2 ...................................................... 22.7d

Recurring Training ................................................................................ 0.0 ........................................................ 22.1e

VII. Additional Overtime ............................................................................... 20.9 ...................................................... 17.5d
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38947

TABLE 1.—COMPARISON OF COSTS—PROPOSAL TO FINAL—Continued

[$ Millions—Present Value of 20-year Costs]

Regulatory component Proposal Final

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

aThe 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. bThe 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. cThe 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. dThese costs are slightly different from the proposal because of changes in the implementation schedule.

eFSIS added costs for recurring training based on the review of public comments.

fBased 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
38948 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 HACCPbased 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 timetemperature 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 clearcut 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
38950 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 nonnegotiable 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
38952 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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, problemsolving 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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.
38954 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 twotiered 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 recordkeeping 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 HACCPcontrolled 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 readyto-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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 readyto-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 costbenefit 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.
38956 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

The estimated annual industry costs

(not discounted) are summarized in

Table 2. These annual costs vary over

the first four years as the new HACCPbased 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]

Effectiveness in

reducing pathogens in the

manufacturing

sector (percent)

Public health

benefits Industry

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 HACCPbased inspection program will be fully

implemented in 42 months, and benefits

should accrue during those 42 months

as well as in the 11⁄2 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 twothirds 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
38958 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 1⁄10th of a pound per year.

In aggregate, with a high impact
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 wellcharacterized 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
38960 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 subpopulations. 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 doseresponse 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-toTable, 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 readyto-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
38962 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 outof-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-toeat 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 casefatality 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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

Pathogen Estimated number of

cases

Estimated

number of

deaths

Source(s) for case and

death estimates

Percent

foodborne Source

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.
38964 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 4.—SOURCES OF DATA FOR SELECTED PATHOGENS, 1993—Continued

Pathogen Estimated number of

cases

Estimated

number of

deaths

Source(s) for case and

death estimates

Percent

foodborne Source

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

Pathogen

Foodborne illness

Foodborne *

costs (bil $)

Percent

from

meat/

poultry

(%)

Meat/poultry related Total

costs *

meat/

poultry

(bil $)

Est. No. of

cases

Est. No.

deaths

Est. No. of

cases

Est. No.

deaths

Bacteria:

Campylobacter jejuni or coli ................. 1,375,000–

1,750,000

110–511 0.6–1.0 75 1,031,250–

1,312,500

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–

7,130,767

2,654–6,546 2.9–6.7 N/A 2,147,513–

4,966,884

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–

7,132,823

2,695–6,587 5.6–9.4 N/A 2,149,569–

4,968,940

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38965

final rule implementing a new HACCPbased 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

Pathogen

Percentage

of total

cases attributed to

meat and

poultry a

1993 (percent)

Percentage

of total cases

attributed to

meat and

poultry, 1995

(percent)

Estimated total

cases, 1993

Estimated total cases,

1995

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 crosscontamination 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 crosscontamination would have led to more

outbreaks makes sense, if the available

estimates on incidence were heavily
38966 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 HACCPbased 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 wellrecognized 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 crosscontamination 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 rawproduct 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.
38968 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 federallyinspected establishments in operation as

of August 1994. The preliminary

analysis and this final RIA combine

1993 production data with the

population of federally and stateinspected 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 onetime, 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 HACCPbased 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
38970 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

SIC

code Standard industrial classification

Number of

establishments

Cumulative

number of

establishments

SBA size standard

2011 ... Meat packing establishments .......................................................................................... 1,503 1,503 500 employees.

5147 ... Meats and meat products ................................................................................................ 1,312 2,815 100 employees.

2013 ... Sausages and other prepared meats .............................................................................. 939 3,754 500 employees.

2015 ... Poultry slaughtering and processing ............................................................................... 438 4,192 500 employees.

4222 ... Refrigerated warehousing and storage ........................................................................... 356 4,548 $18,500,000.

5421 ... Meat and fish markets ..................................................................................................... 309 4,857 $5,000,000.

5144 ... Poultry and poultry products ........................................................................................... 268 5,125 100 employees.

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 products, nec ............................................................................... 65 5,948 100 employees.

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

Establishment

category Definition

No. of

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

TABLE 8.—SIZE CATEGORIES FOR

FEDERALLY INSPECTED ESTABLISHMENTS—Continued

Establishment

category Definition

No. of

establishments

Final Rule (Sequencing of HACCP)

Large ......................... ≥500 Employees.353

Small a ....................... 10–499 Employees.2,941

Very small b ............... <10 Employees

or <$2.5

Million.

2,892

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
38972 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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]

Establishment category Plan development cost

Annual recordkeeping costTraining

cost

Total

first

year

cost

Recurring

annual

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]

Establishment

category

No. of

establishments

First

year

costs

Recurring

costs

High ............... 849 $4,276 $3,484

Medium .......... 3,103 8,079 6,839

TABLE 10.—COSTS OF SANITATION

SOP’S—Continued

[Dollars in thousands]

Establishment

category

No. of

establishments

First

year

costs

Recurring

costs

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.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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
38974 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

TABLE 11.—COST OF A SALMONELLA

SAMPLE ANALYSIS FOR ESTABLISHMENTS WITH NO IN-HOUSE LABORATORY—Continued

(Dollars)

Component Cost

Collecting and Packaging ................... 3.75

Total ................................................ 33.35

The establishment without an inhouse 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]

Establishment category

Training for

aseptic

sampling

Sampling

plan development

Sample collection and

analysis

Recording

and review

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]

Establishment category

Number of raw

product operations

First year

costs

Recurring

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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 positivenegative 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
38976 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

Category Very

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 preimplementation 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 preimplementation 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 inhouse 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
38978 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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-today 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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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.
38980 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 inhouse 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 (300×52)

and swine slaughter is under 52,000

(52×1,000). The other 1,220 stateinspected 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 category

Number establishments

Sampling range per day Average sampling rate per

establishment

Annual

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 under 60,000 ...... 108 NA ...................................... One per week (26 weeks) 2,808

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 category

Number of

establishmentsSampling range Average sampling rate per

establishment

Annual

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/or hogs between

20,000 and 260,000.

216 One per week—one per

day.

1.5 per week ...................... 16,430

Under 6,000 cattle and under 20,000 Hogs .................... 1,990 NA ...................................... One per week (26 weeks) 51,740

Total ...................................................................... 2,318 NA ...................................... NA ...................................... 252,640

NA—Not applicable.
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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]

Production Category

Number of

establishments

(number of

annual samples)

Training for

aseptic

sampling

Sampling

plan development

Samples

collection

and analysis

(recurring)

Recording

and review

(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]

Production category

Number of

establishments

(number of

annual samples)

Training for

aseptic

sampling

Sampling

plan development

Samples

collection

and analysis (recurring)

Recording

and review

(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
38982 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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 difficulty

Plan sequence

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

Establishment category

Number establishments

Number

plans

Total

cost

($000)

Average

cost

per

plan

(dollars)

Annual

reassessment

($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
38984 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

Manufacturing operation

Federal

inspected

establishments

State inspected

establishments

Total

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) × (1.1 average

production lines)

× (5 minutes per CCP per day ÷ 60

minutes per hour)

× (5 CCP’s per line)

× ($12.87 per hour) × (260 days per year)

= § 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]

Establishment

category

Recording

observations

Certifying

records

Maintaining

records

Recurring

annual

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]

Establishment category

Number

of establishments

Annual

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,
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 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 HACCPtrained 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 HACCPtrained 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 asneeded 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, upfront 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.
38986 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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]

Establishment categoryNumber

of employees

One-time

cost

Recurring

costs

(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
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations 38987

TABLE 30.—SUMMARY OF COSTS FOR A TYPICAL LOW VOLUME ESTABLISHMENT—Continued

[Dollars]

Cost category Year 1 Year 2 Year 3 Year 4 Year 5+

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

aThis cost for the 112 low volume TQC establishments would be $64.

bThe estimate of $1,200 is based on monthly testing for two products and an antimicrobial rinse for one.

cThe 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). dAverage 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. eThe 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]

Requirement

Development and

Implementation

costs

Recurring

Annual

Costs

Sanitation SOP’s ... 190 1,242

TABLE 31.—COSTS FOR TYPICAL SINGLE-SHIFT PROCESSING ESTABLISHMENT—Continued

[Dollars]

Requirement

Development and

Implementation

costs

Recurring

Annual

Costs

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]

Requirement

Development and

implementation

costs

Recurring

annual

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
38988 Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules and Regulations

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

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