HACCP-Based Meat and Poultry Inspection Concepts

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 96-008N]

HACCP-Based Meat and Poultry Inspection Concepts

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) must change how

resources are allocated in order to improve regulation of the meat and

poultry industries after implementation of the Pathogen Reduction;

Hazard Analysis and Critical Control Point (PR/HACCP)Systems final

rule. Every aspect of traditional FSIS methods of inspection for

slaughter and processing needs to be reconsidered. All methods are

subject to change as long as the Agency can fulfill its

responsibilities to ensure that the industries produce safe, wholesome,

unadulterated and properly labeled meat and poultry products. The

Agency is also considering adding methods to better ensure food safety

and other consumer protections in distribution channels.

FSIS is seeking comments on the development of new inspection

models for slaughter and processing in a HACCP environment. FSIS also

invites the public to participate in the development of new inspection

models and will hold a public meeting to facilitate that process.

DATES: The public meeting is scheduled for June 24, 1997, from 8 a.m.

to 5 p.m.

COMMENTS: Comments are welcome at any time. Please submit written

comments to Ms. Patricia Stolfa, Assistant Deputy Administrator, Office

of Policy, Program Development and Evaluation, Room 402 Cotton Annex,

300 12th Street SW, Washington, D.C. 20250-3700. Comments may also be

provided by facsimile (202-401-1760).

ADDRESSES: The public meeting will be held in Galleries 1, 2, and 3 of

the Arlington Hilton Hotel, 950 North Stafford Street, Arlington, VA

22203. The hotel has reserved a block of rooms until June 13 for

participants in the public meeting. Please contact the hotel at (800)

445-8667 and cite code USDAFSIS to make reservations.

FOR FURTHER INFORMATION CONTACT: To register for the public meeting,

contact Ms. Mary Gioglio at (202) 501-7244, (202) 501-7138, or FAX

(202) 501-7642. Persons wishing to speak at the public meeting are

requested to submit an advance written summary of their remarks. Please

submit written summaries pertaining to in-plant and/or in distribution

inspection concepts to Ms. Patricia Stolfa, Assistant Deputy

Administrator, Office of Policy, Program Development and Evaluation,

Room 402 Cotton Annex, 300 12th Street SW,Washington, D.C. 20250-3700.

Participants who require a sign language interpreter or other special

accommodations should contact Ms. Gioglio at the above telephone or FAX

numbers by June 10, 1997.

Background

This notice is organized into five sections. Section I

(Introduction) explains the current status of the FSIS regulatory

program and its food safety goals and strategy, and describes the

Agency's consumer protection activities included in its current

program. This section discusses the need for resource redeployment in

light of the Agency's overall modernization effort. Section II (Current

Inspection System) explains the current program and identifies

significant inconsistencies between HACCP and the current program. This

section also summarizes external support for inspection reform. Section

III (HACCP-based Inspection Development Project) explains the project,

describes inspection model development activities, announces a public

process to assist in the development of new inspection models, and

solicits volunteer establishments for participation in development

activities. Section IV (New Inspection Models) presents current agency

thinking on new in-plant and in-distribution models. Section V (Public

Meeting) proposes material questions the Agency will address through

the public process.

I. Introduction

Food Safety Goal

FSIS is committed to making fundamental improvements in the safety

of America's meat and poultry supply in order to reduce the incidence

of foodborne illness. In the preamble to the proposed rule ``Pathogen

Reduction; Hazard Analysis and Critical Control Points (PR/HACCP)

Systems'' (60 FR 6774; February 3, 1995), FSIS stated its

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goal as follows: ``* * * 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.)

An essential first step in achieving that goal was accomplished

with promulgation of the PR/HACCP Systems final rule (61 FR 38806; July

25, 1996).

The PR/HACCP final rule mandates substantial change within every

inspected meat and poultry establishment. The new regulations: (1)

Require that each establishment develop, implement, and follow written

sanitation standard operating procedures (S-SOP's); (2) require regular

microbial testing by slaughter establishments to verify the adequacy of

their 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 risk-

based system of preventive controls known as HACCP to improve product

safety.

In mandating these reforms, FSIS recognized that in-plant

technological and procedural solutions could not address foodborne

illness hazards occurring in meat and poultry products outside official

establishments. These components of the goal could be achieved only

through a more comprehensive food safety strategy that would bring

about improvements in risk management at each step in the meat and

poultry production chain. Efforts must extend from just before

slaughter, through slaughter, processing, distribution, and retail sale

or food service, to consumers.

FSIS' Food Safety Strategy

The food safety strategy FSIS outlined in its PR/HACCP final rule

included five major elements:

(1) Provision for systematic prevention or reduction of biological,

chemical, and physical hazards through adoption by meat and poultry

establishments of science-based process control systems.

(2) Targeted efforts to control and reduce harmful bacteria on raw

meat and poultry products.

(3) Adoption of food safety performance standards that provide a

catalyst for innovation to improve food safety and a measure of

accountability for achieving acceptable food safety results.

(4) Removal of unnecessary regulatory obstacles to innovation.

(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.

The PR/HACCP final rule included regulatory provisions to implement

food safety strategy components (1) Hazard prevention through HACCP and

other production control systems, (2) reduction and control of

bacterial pathogens and (3) adoption of food safety performance

standards. Earlier, FSIS had published an Advance Notice of Proposed

Rulemaking (ANPR) (60 FR 67469 December 29, 1995) in pursuit of

strategy component (4), the elimination of unnecessary regulatory

obstacles to innovation. That notice announced a comprehensive review

of all FSIS regulations to determine which will still be needed when

the PR/HACCP final rule becomes effective and which ought to be

revised, streamlined or eliminated. That review is well underway and a

series of proposals will be published in the Federal Register to

consolidate and remove or modify existing requirements to make them

performance standards.

The PR/HACCP final rule did not address hazards arising at other

points in the farm to table continuum: for instance, during the

transportation, storage and retail, restaurant or food service sale of

meat and poultry products. Yet each stage of production presents

hazards of pathogen and other contamination and each provides

opportunities for preventing or mitigating these hazards. Those in

control of each segment of the farm to table continuum must accept

their share of the responsibility for identifying and preventing or

reducing food safety hazards that are under their operational control.

FSIS's food safety mandate requires that the Agency address

foodborne illness hazards within each segment of the food production

chain and that it implement and encourage prevention strategies that

improve the whole system. FSIS remains committed to a farm to table

food safety strategy based on these principles. Commenters on the PR/

HACCP proposed rule supported FSIS modernization of its regulatory

program to include all segments of the food production and

transportation industries.

The Agency also will be cooperating with animal producers,

academia, the Animal and Plant Health Inspection Service, the Food and

Drug Administration, the States, and other government agencies to

develop and foster voluntary food safety measures which can be taken on

the farm to decrease the public health hazards in animals presented for

slaughter.

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, FDA, and

the State and local agencies recognize that, if they are to reduce

foodborne illness to the maximum extent possible, they must coordinate

their food safety missions when addressing hazards that may arise in

distribution and at retail. FSIS has initiated a number of activities

which could form the basis for future regulatory activities at various

points on the continuum.

In 1995, FSIS, FDA, and the Department of Transportation contracted

with an expert group, the transportation Technical Analysis Group

(TAG), to identify the hazards associated with transportation of

perishable foods and to recommend reasonable controls that might be

employed by industry to ensure food safety. Using the HACCP system, the

TAG conducted a hazard analysis of the two major areas of concern in

the trucking transportation chain: the transport of live animals or

fresh materials, and the transport of processed or finished products

that are perishable. The TAG concluded that a program to ensure more

sanitary and temperature-controlled food transportation would benefit

both the industry and consumers.

In conjunction with FDA, FSIS issued a November 22, 1996, Advance

Notice Of Proposed Rulemaking (61 FR 59372) seeking comments and

information on various issues and alternatives for ensuring the safety

of potentially hazardous foods during transportation and storage. FSIS

and FDA also co-hosted a conference in November 1996, focusing on

transportation, storage and distribution of potentially hazardous

foods. The conferees discussed ideas related to in-distribution

regulatory activities to be considered by FSIS and FDA regarding meat,

poultry, eggs,

[[Page 31555]]

seafood, dairy, and other potentially hazardous food products. A

transcript of this conference is available from the FSIS hearing clerk.

Other Consumer Protection Activities

In addition to its food safety goal, FSIS also has other consumer

protection responsibilities under the laws it administers that are the

subject of many agency activities. These include ensuring that meat and

poultry products are truthfully labeled and not economically

adulterated with less valuable components such as water, and ensuring

that consumers are protected from unwholesome meat and poultry products

which, while not actually unsafe, might contain components which are

undesirable.

Regulatory Objectives

The FSIS regulatory program of the future will be designed first to

meet the Agency's food safety goal and strategy, along with our

consumer protection responsibilities. The Agency realizes it must have

the participation of all stakeholders to achieve our food safety goal

and other objectives. FSIS is therefore seeking public input on the

design and development of its HACCP-based program. FSIS believes that

there are at least three essential objectives that will form the basis

of this modern HACCP-based program.

First, FSIS must ensure that any new inspection models do

not diminish the current food safety and consumer protection

achievements that result from (1) carcass-by-carcass and bird-by-bird

slaughter inspection, and (2) Agency inspection oversight of production

control systems in further processing establishments.

The second objective is to effectively and efficiently

oversee, evaluate, and verify industry implementation of the PR/HACCP

final rule. HACCP, combined with other production control systems and

FSIS inspection oversight, are complementary and interrelated, but

independent activities that, taken together, enhance the safety of

foods for consumers and thereby earn their confidence. Maintenance of

such confidence shall be the critical test for any changes.

The third regulatory objective is to ensure that meat and

poultry products are handled and transported by allied industries under

conditions which maintain their safety and integrity. FSIS intends to

gather information about industry practices relative to handling,

transport, and storage of meat and poultry products to determine

whether businesses are effectively managing food safety risks and

ensuring that other consumer protections remain intact.

Need for Resource Redeployment

FSIS will be unable to meet its food safety goal and other

regulatory objectives unless it changes the way it deploys its

resources. Currently, inspectors are fully, and frequently more than

fully, occupied with carrying out the tasks of the present inspection

system. Those tasks require that about 45% of the entire inspector

field force be stationed at fixed positions along production lines in

slaughter establishments. Current slaughter inspection staffing is

directly related to industry production capacity. Higher production

capacity requires the Agency to staff more inspection positions.

Occasionally, staffing limitations negatively impact plant production

rates.

FSIS recognizes that the opportunities for inspector redeployment

are limited because current slaughter inspection regulations and

procedures are, by design, resource-intensive. Seventy-two percent

(72%) of the agency's in-plant inspection force is now assigned to

slaughter or combination slaughter and processing establishments that

make up only twenty-one (21%) of all establishments requiring federal

inspection. Current slaughter inspection procedures obligate sixty-two

percent (62%) of those in-plant slaughter inspectors (or 45% of the

entire inspection force) to carcass-by-carcass and bird-by-bird post-

mortem inspection.

FSIS believes it must explore alternatives to its current

inspection design and resource deployment models. Redeployed resources

would be allocated to new inplant functions associated with oversight,

evaluation, and verification of the PR/HACCP final rule implementation.

Other redeployed resources could be assigned to in-distribution

oversight.

II. The Current Inspection System

This section describes current inspection system practices,

especially within slaughter establishments, and illuminates several

crucial problems with the current system that present barriers to the

efficient and effective allocation of resources.

FSIS now carries out its meat and poultry food safety

responsibilities primarily through in-plant slaughter and processing

inspection programs. Under the current in-plant inspection system, FSIS

inspects carcasses and parts of all livestock and birds to detect

noncompliance with regulatory requirements, and requires correction of

each product, production, facility, equipment and sanitation defect

that occurs.

The current inspection system assumes that all livestock and birds

and their carcasses and parts are presented for inspection with the

intention of being prepared for use as human food. FSIS inspectors are

required to determine which are wholesome, not adulterated, and capable

of use as human food. FSIS inspectors decide whether to pass, condemn,

or allow salvage of carcasses or parts thereof. Under the current

system, FSIS uses inspectors at fixed stations on each slaughter line

to organoleptically identify disease lesions or defects in carcasses,

viscera and, in some species, heads.

Problems With Current Inspection

FSIS has identified several problems with the current approach. One

major problem is that as slaughter establishments have come to rely on

FSIS personnel to sort acceptable from unacceptable product, the

establishments have no mandate or incentive to remove carcasses and

parts prior to presentation for inspection. Thus, the proper roles of

industry and inspection personnel are obscured. FSIS' resources are

inappropriately and inefficiently used when FSIS slaughter inspectors

take on the industry's responsibility for finding defects, identifying

corrective actions, and solving production control problems.

A much more significant problem with the current inspection system

is that it does not permit FSIS to allocate resources according to

public health risk. For instance, the current line inspection system

required by regulation in meat and poultry slaughter establishments

focuses substantial FSIS inspection resources on areas that do not

present significant food safety risks. The carcass inspection

procedures carried out by FSIS inspectors today were designed many

years ago in response to a higher prevalence of disease in the animal

populations of that era. Over the years, significant advancements have

been made in the control or eradication of many animal diseases,

especially those that are transmissible to humans, such as tuberculosis

and brucellosis. Also, animal production practices have become more

efficient so that most livestock and poultry are slaughtered at a young

age, generally free of diseases more common in older animals.

Nonetheless, inspection methods have not changed.

Inspection methods have also not been modified sufficiently to

address

[[Page 31556]]

the microbial causes of foodborne illness. Current inspection methods

continue to rely on organoleptic identification of defects as

indicators of possible microbial risk. Measuring microbial hazards in

the design of HACCP plans through testing for actual microbial levels

and validation of control measures will occur during implementation of

the PR/HACCP final rule. Since new inspection models should reflect

this focus on pathogen reduction and microbial monitoring and

verification, the current reliance on organoleptic inspection should be

carefully reassessed.

The following data illustrate the results of current FSIS line

inspection. The overall level of carcass condemnation is low, 0.9

percent of young chickens, 0.1 percent of steers and heifers, and 0.3

percent of market hogs. Many carcass defects that result in

condemnation by FSIS slaughter inspectors today are aesthetic rather

than food safety related, such as pigmentary conditions and tumors.

Condemnation for food safety reasons is even lower, 0.4 percent of

young chickens, 0.08 percent of steers and heifers, and 0.23 percent of

market hogs. Inspection resources are now used to directly observe

1,000 young chickens to find four (4) that should be condemned for food

safety concerns. Similarly 10,000 steers and heifers are observed to

condemn eight (8) and 1,000 market hogs (barrows and gilts) are

observed to condemn two (2). Tables 1, 2 and 3 summarize carcass

condemnation data from fiscal year 1995. These data underscore the need

to reassess our current use of extensive inspection resources in this

area and to ask what staffing levels and patterns are appropriate for

the level of risk they address. FSIS believes that updating the

diseases and conditions subject to condemnation or restriction under

the PPIA and FMIA is long overdue and crucial to the development of new

inspection models. Certain diseases and conditions unrelated to food

safety, but currently addressed in the regulations, may be more

appropriately addressed by industry monitoring.

Table 1.--FY 1995 Condemnation Data for Young Chickens

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Total slaughtered 7,512,916,376

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Number Percent

Condemnation condition Potential public health concern condemned condemned \1\

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

Septicemia/toxemia......................... Yes................................ 23,684,719 0.30

Synovitis.................................. No................................. 489,101 0.01

Contamination.............................. Yes................................ 6,190,429 0.08

Manufacturing defects...................... No................................. 20,984,146 0.28

Aesthetic defects.......................... No................................. 18,990,884 0.25

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

Totals................................. ................................. 70,339,279 0.94

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

\1\ Percentages do not total 0.94 due to rounding.

The disease conditions with potential public health implications

are easily identified by visual assessment. Manufacturing defects

include such items as bruises, cadaver, over scalded, missing viscera,

and plant rejects. Aesthetic conditions with no known food safety

concern include leukosis, other tumors, and airsacculitis.

Table 2.--FY 1995 Condemnation Data for Steers and Heifers

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Total slaughtered 28,807,882

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Number Percent

Condemnation condition Potential public health concern condemned condemned \1\

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

Septicemia/toxemia......................... Yes................................ 10,630 0.04

Inflammatory conditions.................... Yes................................ 8,270 0.03

Tuberculosis............................... Yes................................ 41 0.00

Ante-mortem conditions..................... Yes................................ 1,802 0.01

Parasitic/fungal........................... Yes................................ 2,678 0.01

Metabolic.................................. No................................. 2,081 0.01

Visually identifiable...................... No................................. 2,352 0.01

Tumors..................................... No................................. 671 0.00

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Totals..................................... .................................. 28,525 0.10

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\1\ Percentages do not total 0.10 due to rounding.

Some condemnable conditions are identified ante-mortem by visual

assessment and animals with these conditions are not allowed to enter

the slaughter department, including animals arriving dead, those with

central nervous system disorders, moribund animals, those with tetanus,

and those with fever (pyrexia). Metabolic conditions include cachexia

and uremia and are identified by visual assessment. Other conditions

are identifiable post-mortem by visual assessment, including icterus,

eosinophilic myositis, tumors, and pigment conditions.

[[Page 31557]]

Table 3.--FY 1995 Condemnation Data for Barrows and Gilts

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Total slaughtered 89,530,876

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Number Percent

Condemnation condition Potential public health concern condemned condemned \1\

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

Septicemia/toxemia......................... Yes................................ 36,641 0.04

Inflammatory conditions.................... Yes................................ 24,701 0.03

Tuberculosis............................... No................................. 1,262 0.00

Ante-mortem conditions..................... Yes................................ 137,998 0.15

Parasitic/fungal........................... Yes................................ 47 0.00

Metabolic.................................. No................................. 1,448 0.00

Visually identifiable...................... No................................. 14,717 0.02

Tumors..................................... No................................. 2,685 0.00

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

Totals................................. .................................. 219,499 0.25

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\1\ Percentages do not total 0.25 due to rounding.

The conditions with potential public health implications are easily

identified by visual assessment. Some condemnable conditions are

identified on livestock and birds ante-mortem by visual assessment and

not allowed to enter the slaughter department, including animals

arriving dead (accounts for over one-half of all condemnations), those

with central nervous system disorders, moribund animals, those with

tetanus, and those with fever (pyrexia). Metabolic conditions include

cachexia and uremia and are identified by visual assessment. Other

conditions are identifiable at post-mortem by visual assessment,

including icterus, eosinophilic myositis, tumors, and pigment

conditions.

Despite the fact that many condemnations are unrelated to public

health risks, today FSIS still fully staffs every meat and poultry

establishment slaughter line inspection station. Assigning top priority

to slaughter line inspection activities to detect quality as well as

defects of public health concern directly affects the Agency's ability

to staff other critical food safety inspection activities and may not

be the best use of inspection resources. For example, FSIS inspectors

in slaughter establishments are assigned the task of verifying

establishment production control systems for sanitary dressing of

slaughtered animals and operational sanitation of equipment and

facilities. If, however, slaughter line inspection positions become

vacant, inspectors are removed from these important verification duties

to fill the line positions. This means that important production

control systems, which prevent or eliminate hazards such as bacterial

pathogens, are only monitored by plant employees with little FSIS

inspection verification.

The current inspection system can also raise barriers to

establishment innovation through new technology and improved production

procedures. Establishments should have the flexibility to implement the

PR/HACCP final rule and to make decisions about how they may best

control food safety hazards and meet performance standards.

Establishments should have the latitude to develop new production

control methods to detect food safety and non-food safety related

defects in carcasses and parts. Current slaughter inspection methods,

particularly fixed inspector stations on establishment slaughter lines,

limits industry innovation.

External Support for Inspection Reform

Recent outbreaks of foodborne illness have focused attention on the

need for improving the current system. Studies conducted over the past

decade by the National Academy of Sciences (NAS), the General

Accounting Office, and by FSIS have established the need for

fundamental change in the meat and poultry inspection program. Two

elements have been commonly expressed: FSIS should revise and reform

inspection to (1) Improve food safety through a reduction in foodborne

illness caused by pathogenic bacteria on meat and poultry products and

(2) make better use of its resources. Bacteria, including Salmonella,

E. Coli 0157:H7, Campylobacter and Listeria Monocytogenes, are

significant food safety hazards associated with meat and poultry

products. The contamination of meat and/or poultry with these bacteria

is estimated to result annually in as many as 4,000 deaths and

5,000,000 illnesses.

The theme of NAS's recommendations is that FSIS should reduce its

reliance on organoleptic inspection and shift to prevention-oriented

inspection systems based on risk assessment. The 1985 NAS report, Meat

and Poultry Inspection: The Scientific Basis of the Nation's Program,

recommended that FSIS focus on pathogenic organisms and require that

all official establishments operate under a HACCP system for control of

pathogens and other safety hazards. This report strongly encouraged

``FSIS 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.''

Two later NAS studies reinforced this recommendation. The 1987 NAS

report Poultry Inspection: The Basis for a Risk Assessment Approach

concluded ``that the present system of inspection does very little to

protect the public against microbial hazards in young chickens.'' The

report continued to say that ``[Agency] resources are not always

allocated to the right points and the resources that are properly

directed are not achieving measurable results. Major changes are

required in the poultry inspection system if public health is to be

protected and if the investment of resources is to have maximum

effect.'' It recommended that FSIS adopt an inspection strategy ``that

is more likely to have a substantial impact on human diseases.'' The

1990 NAS report Cattle Inspection: Committee on Evaluation of USDA

Streamlined Inspection System for Cattle (SIS-C) added that although

``traditional meat inspection, relying on organoleptic examinations,

can ensure satisfactory meat product quality, it is not fully effective

in protecting the public against foodborne health hazards not

detectable with these techniques. The future will require new ways of

preventing public exposure to contaminants, scientifically valid and

believable methods of evaluating inspection technology, and

implementation of appropriate portions of HACCP programs.''

[[Page 31558]]

The General Accounting Office (GAO) has advocated similar

improvements for meat and poultry inspection in its reports. (Food

Safety: A Unified, Risk-Based Food Safety System Needed (1994); Meat

Safety: Inspection System's Ability to Detect Harmful Bacteria Remains

Limited (1994); Food Safety: Building a Scientific, Risk-Based Meat and

Poultry Inspection System (1993); Food Safety and Quality--Uniform,

Risk-Based Inspection System Needed to Ensure Safe Food Supply (1992).)

The GAO has endorsed HACCP as a scientific, risk-based system that

would permit redeployment of FSIS resources in a manner that will

better protect the public from foodborne illness. The 1994 GAO report,

Meat Safety: Inspection System's Ability to Detect Harmful Bacteria

Remains Limited, stated the resource problem clearly. ``Labor-intensive

inspection procedures and inflexible inspection frequencies drain

resources that could be put to better use in a risk-based system. To

better protect the public from foodborne illnesses, FSIS must move to a

modern, scientific, risk-based inspection system. Such a system would

allow FSIS to target its resources toward the higher-risk meat and

poultry products by increasing inspection of such products.''

Another proponent of inspection reform has been the National

Advisory Committee on Microbiological Criteria for Foods (NACMCF),

which prepared reports on the development and implementation of HACCP.

NACMCF supported the use of risk analysis for allocation of resources

to control food safety.

III. HACCP-Based Inspection Development Project

With this notice, FSIS is initiating the process of dialogue with

all interested parties to advance the design and development of new

inspection models to be tested in a series of trials in volunteer meat

and poultry slaughter establishments and in distribution channels. This

project is intended to produce a fully integrated system of regulatory

oversight and controls that will permit FSIS to deploy inspection

resources more effectively in-plant and between in-plant and in-

distribution sites in accord with food safety and other consumer

protection requirements.

Objectives for New Inspection Models

The development of new in-plant and in-distribution inspection

models will occur in three phases.

Phase I. Initiation: Conduct public meeting to explain the need for

new inspection models and to commence a public dialogue on the

available options for their design, complete preliminary designs, and

prepare for development activities.

Phase II. Development: Conduct development activities in commercial

establishments and at in-distribution points to refine the models,

gather data, generate implementation strategies.

Phase III. Completion: Write the final report, publish results for

comment, and initiate rulemaking, as appropriate, to change existing

inspection procedures.

During each phase, the in-plant and in-distribution inspection

methods will be developed separately. The purpose of a two-track

development is to test and refine the new inspection concepts in both

commercially operating meat and poultry establishments and with in-

distribution activities at several geographic sites. Throughout the

development phase, FSIS will be prepared to revise or suspend current

inspection procedures provided that appropriate oversight controls are

maintained in volunteer establishments.

This notice announces the first step in Phase I, a public meeting

to present the need for new inspection concepts and to commence a

public dialogue on these concepts. At this meeting, FSIS will describe

its current thinking, seek information from all stakeholders, and use

that input to complete preliminary designs for new in-plant and in-

distribution inspection models suitable for testing and development.

FSIS needs the broadest possible public participation in the

development of these models.

FSIS will prepare a transcript of the public meeting. The

transcript and copies of any papers presented at the meeting will be

available in the FSIS Docket Clerk's Office, Food Safety and Inspection

Service, U.S. Department of Agriculture, Washington, DC 20250-3700.

Development Phase

FSIS development activities for new in-plant inspection systems

will critically examine how well each design meets the Agency's

regulatory objectives. In-plant tests will be conducted in

establishments that predominantly slaughter young chickens, market hogs

and steers/heifers. Volunteer establishments will be sought for each

class. Young chickens, market hogs and steers/heifers were selected for

these development activities because they tend to be healthy and

uniform; they also represent over ninety percent (90%) of meat and

poultry slaughtered in the United States.

Slaughter and combination slaughter and processing plants

participating as volunteers will be required to have HACCP and other

production controls in place to ensure that all consumer protection

goals of the program are being met. Participating establishments must

also have successful S-SOP's and a working generic E. coli testing

program.

FSIS solicits establishments to volunteer for participation in the

in-plant development phase. Establishments requesting to participate

should request to do so in writing to FSIS at the address provided in

the ADDRESSES portion of this notice. Written applications for

participation in the development activities should provide a

description of establishment operations that includes predominant

species slaughtered, number and type of slaughter lines, and a

certification that all applicable elements of the PR/HACCP final rule

have been or will be fully implemented. FSIS will conduct an on-site

visit to verify eligibility for participation in the development

activities.

FSIS intends to assign inspection work more broadly during the in-

plant development activities to explore new methods for performing

regulatory work. For instance, if volunteer establishments conduct both

slaughter and processing operations, inspectors might be assigned to

perform work that cuts across traditional job lines. Within the

slaughter operation, inspectors could provide oversight, evaluation,

and verification of carcass-by-carcass and bird-by-bird industry

determination of acceptable and unacceptable product. Inspectors would

have access to perform hands-on inspection of carcasses or birds. They

would perform additional tasks in slaughter and processing for

assurance that products bearing the official inspection mark are not

adulterated or misbranded, including verification of HACCP or S-SOP's.

Such changes would provide FSIS with considerable data with which to

evaluate the effectiveness of its inspection resources.

Staffing requirements for new in-plant inspection models could also

vary depending on factors such as species of animal, the

establishment's production system, and slaughter line configurations.

Nontraditional staffing criteria are under development. In-plant

slaughter inspection could (1) be staffed with available inspectors,

(2) provide for rotation of inspection personnel between slaughter and

processing duties, (3) provide continuous oversight of establishment

production systems, (4) include scheduling of slaughter inspection

tasks, and (5) provide unscheduled time for all inspection

[[Page 31559]]

personnel to conduct additional inspection activities in the

establishment.

In view of the mix of skills to be found among slaughter inspection

personnel, all slaughter inspectors currently assigned to the volunteer

establishments will be trained for the project to perform (1) carcass-

by-carcass and bird-by-bird slaughter inspection oversight, (2)

verification of HACCP and related production control systems, (3)

verification of establishment S-SOP's and (4) sampling.

The in-distribution development activities will be conducted on a

separate track. In-distribution concepts will be studied in geographic

areas selected to provide a variety of population densities and

differing logistical challenges for scheduling work. In addition, two

staffing options will be discussed at the public meeting: (1)

Inspectors assigned only to in-distribution activities, and (2)

inspectors who divide their time between in-plant and in-distribution

work. Both options will be considered for application in rural as well

as urban areas.

The in-distribution development activities will be staffed by

experienced in-plant inspectors with prior training in processing

inspection and supplementary training for the new work. This work will

include in-plant tasks that have been identified to be supplemented or

replaced by in-distribution oversight and tasks to determine the

feasibility, efficiency, and effectiveness of performing food safety

and other consumer protection tasks in distribution.

Completion

Upon completion of the development activities, FSIS will prepare a

project report presenting a thorough evaluation of the in-plant and in-

distribution inspection models tested. The Agency will decide at this

point whether further testing of the models should be conducted or

whether to initiate rulemaking to adopt and implement the new models

nationally.

IV. New Inspection Models

The following criteria will be used to design and evaluate new in-

plant and in-distribution models accepted for testing. The models

should:

1. Emphasize industry responsibility for food safety and other

consumer protection activities and government responsibility to verify

that these objectives are met.

2. Include inspection procedures that detach inspectors from

establishment production functions and from sanitation management.

3. Prioritize in-plant work to meet current inspection system

objectives and verify that HACCP and other control systems and

sanitation procedures are effective; provide appropriate priority to

other consumer protection issues such as misbranding or economic

adulteration.

4. Result from an assessment of all in-plant regulatory work to

determine whether some tasks can be performed effectively and

efficiently in-distribution and, where more appropriate, supplement

some in-plant regulatory work with in-distribution oversight.

5. Identify and prioritize new in-distribution regulatory work,

including oversight of how industry manages health and safety hazards

that occur after meat and poultry products leave a USDA-inspected

establishment and verification that products in-distribution are not

misbranded or economically adulterated.

FSIS will develop new in-plant inspection models for slaughter

establishments and combination slaughter and processing establishments

to help the Agency properly allocate resources between oversight,

evaluation and verification of PR/HACCP final rule implementation and

activities to accomplish other consumer protection objectives. The new

in-plant inspection models must also help the agency in properly

allocating resources between in-plant and in-distribution work

environments.

In-plant Inspection Models

A variation of the current inspection system has been identified as

a model to be considered and discussed at the public meeting announced

by this notice.

Under this in-plant model, the establishment would initiate HACCP

and related control systems to distinguish acceptable from unacceptable

carcasses and parts using current regulatory requirements for

antemortem and postmortem disposition of carcasses and parts.

This model would provide establishments maximum flexibility to

design and exercise more effective and more efficient production

control systems. FSIS inspectors would have complete access to all

carcasses and birds on each slaughter line to directly observe

establishment production systems and verify process controls to ensure

that products are not adulterated or misbranded. Consequently,

establishment product flow plans crafted for compliance with the PR/

HACCP final rule for other production control purposes would not

include fixed FSIS inspection stations.

FSIS intends to judge products for safety and wholesomeness based

upon the entire operation under which they are produced. FSIS

inspectors could provide continuous regulatory oversight of the entire

production operation to include each on-line processing step and all

aspects of the establishment that contribute to product safety and

wholesomeness.

FSIS envisions this inspection model as having three main

components that collectively would ensure equivalent performance to

that level of food safety and other consumer protections provided by

the current regulatory system. Slaughter performance standards that

define an acceptable carcass or part are the basis for the first

inspection component. FSIS would establish performance standards to

replace command and control regulations. Industry systems to meet the

performance standards would satisfy the first component.

The second component is direct verification by FSIS inspectors of

the establishment program. This would be accomplished by FSIS

inspectors who would provide carcass-by-carcass and bird-by-bird

inspection oversight at the slaughter line and by periodic checks to

verify the condition of carcasses and parts the establishment has found

to be acceptable.

The third component is verification of the overall establishment

program for producing acceptable product including verification of

HACCP, other production control systems, and S-SOP's.

This preliminary in-plant inspection model envisioned by FSIS would

require fewer inspectors assigned to slaughter plants, making

inspectors currently assigned to slaughter line positions available for

redeployment. This is consistent with HACCP principles and would reduce

or eliminate distinctions between slaughter and processing inspection

by allowing inspectors to rotate from post-mortem oversight positions

to work such as HACCP verification, finished product standards testing,

Performance Based Inspection System (PBIS) task performance, S-SOP

verification and microbial sampling.

FSIS Verification Activities

Under the new in-plant inspection model, FSIS would not prescribe

how industry must accomplish production control. Establishments would

instead be provided the flexibility, within performance and regulatory

standards set by FSIS, to design specific processes that address

hazards and defects unique

[[Page 31560]]

to their operations. FSIS would ensure that establishment HACCP and

other control system plans for achieving regulatory standards are

adequate and operating properly. Following is an illustration of steps

FSIS inspectors would take to oversee, evaluate, and verify

establishment production control systems.

Observe the production control systems; verify that

process control procedures are being followed by the establishment.

Observe carcasses, parts, or viscera rejected by the

establishment; provide information to the off-line inspector and

veterinarian as to which diseases or conditions are prevalent.

Observe carcasses, parts or viscera accepted by the

establishment; verify removal of obvious condemnable conditions.

Sample carcasses, heads or viscera accepted by the

establishment; select and examine a specific number of carcasses, heads

or viscera to verify the effectiveness of the establishment's system

for ensuring accepted product is wholesome and otherwise eligible for

the mark of inspection.

Review records to determine whether the establishment is

following its production control plans.

Observe product (carcasses, heads, and viscera) to

determine which conditions are present.

Coordinate with establishment manager, who provides

oversight of production control systems, to ensure that performance

standards are being applied correctly.

Conduct product standards testing (e.g., Finished Product

Standards, Acceptable Quality Level) to determine the effectiveness of

establishment production control systems for quality or wholesomeness

defects.

FSIS also will conduct verification checks of establishment

activities other than production control systems. For instance, FSIS

inspectors will:

Perform tasks related to the Performance-Based Inspection

System, including those historically performed after slaughter during

processing.

Conduct HACCP record reviews to verify that the

establishment is monitoring critical control points in accordance with

their HACCP plan.

Verify establishment disposition of rejected product.

Conduct operational verification activities, such as

assessing the establishment's execution of its HACCP plan.

Take samples of product for microbiological, chemical and

physical analysis to verify establishment compliance with its HACCP

plan.

Verify that the establishment is following its sanitation

SOP.

The FSIS Veterinary Medical Officer (VMO) will work closely with

inspectors to provide continuous oversight and thorough documentation

of establishment production control systems. VMO expertise and

responsibilities would include the following:

Serve as the Inspector-in-Charge; supervise food

inspectors.

Evaluate the health of incoming animals through ante-

mortem activities.

Perform ante-mortem inspection of suspect animals.

Verify establishment production control systems to ensure

proper application of disposition standards by inspectors and

establishment personnel.

Verify microbial sampling and testing of product.

Take microbial and histopathological samples of condemned

carcasses to profile etiologies.

Participate in the evaluation of testing or implementation

of new technologies initiated by establishments for identifying

condemnable carcasses.

Serve as liaison with establishment management, industry

technical experts and with local or State public health officials.

In-Distribution Concept

A new in-distribution inspection concept should provide for

verifying industry management of food safety risks that arise after

inspection. Resource allocation issues require an integrated approach

for both food safety and other consumer protection initiatives. Thus,

the in-distribution model may also supplement in-plant oversight of

product labeling, economic adulteration and wholesomeness requirements.

Although FSIS will develop and field-test new concepts for slaughter

and in-distribution separately, FSIS envisions one fully integrated

program that would permit movement of personnel and tasks between the

two activities.

At present, FSIS has no comprehensive rules governing the in-

distribution handling of meat and poultry products. The Agency now

exercises its jurisdiction over product outside inspected

establishments to a limited degree. For example, FSIS has promulgated

safe handling labels for raw meat and poultry products (9 CFR 317.2 (l)

and (m), and 381.125(b)); in many instances those labels are applied at

retail locations. FSIS also verifies and enforces compliance with

requirements concerning transportation to and among inspected

establishments and allied industries, such as renderers and pet food

establishments, conducts scheduled and unscheduled reviews of

warehouses and other in-distribution locations, verifies the recall of

product from in-distribution channels, performs scheduled and

unscheduled product sampling, and investigates complaints from

consumers and others about alleged adulterated or misbranded products.

This approach has been both proactive and reactive. FSIS has not

focused systematically on in-distribution conditions and practices that

contribute to the growth of microbes. FSIS uses resources to detect

problems, educate industry, correct violations, and make appropriate

dispositions on millions of pounds of product. However, the statutes

provide USDA authority to oversee meat and poultry products after they

leave inspected establishments. The statutes provide that one may not

``sell, transport, offer for sale or transportation, or receive for

transportation'' any meat or poultry product that is capable of use as

human food and is ``adulterated or misbranded at the time of such sale,

transportation, offer for sale or transportation, or receipt for

transportation * * *'' (21 U.S.C. 610 and 458(a)(2)). The statutes also

prohibit any action ``intended to cause or [that] has the effect of

causing such articles to be adulterated or misbranded.'' (21 U.S.C.

610(d) and 458(a)(3)).

This authority would encompass the establishment of safety

standards for meat and poultry products from the time they leave an

inspected establishment to final sale or service to consumers. As a

first step, FSIS has yet to determine whether performance standards and

Good Manufacturing Practices could and whether they can be established

for meat and poultry products to prevent growth of harmful bacteria and

introduction of other potential hazards during transportation.

FSIS is considering work accomplished by the transportation TAG, to

identify primary hazards associated with transportation of perishable

foods and controls that might be employed by industry to ensure food

safety. The TAG noted ``that time, temperature, and sanitation are the

three key elements of any control plan'' affecting the transportation

sector. The TAG also concluded that sanitary conditions and practices,

maintenance of product temperature in transit, time in transit, and

practices to reduce opportunities for cross contamination all represent

control points for which the development of regulatory standards, good

manufacturing

[[Page 31561]]

practices, and suitable verification controls are possible.

During in-distribution inspection concept development, FSIS will

gather data to describe impacts on pathogen levels attributable to

present allied industry practices. Data collection sources will include

allied industry members who volunteer to describe quality or safety

problems they experience with meat and poultry received from their

suppliers. These data will suggest points of concern within the

distribution chain that FSIS may need to address in its inspection

planning.

Another data collection effort could be to identify a microbial

baseline for certain products or product lots as they leave inspected

establishments and track them through the distribution chain to detect

and record changes caused by allied industry handling practices. The

nationwide status of the food safety and other consumer protection

aspects of meat and poultry products could be evaluated and profiles

developed. Evaluation of changes in profiles over time would measure

the effectiveness of in-distribution efforts to maintain food safety

and product integrity. Status reports on meat and poultry products

might be correlated with sentinel site surveillance data for foodborne

disease to track the public health impact of farm to table food safety

initiatives.

While time, temperature, and sanitation play a key role in

controlling hazards to perishable foods in transportation, they are not

the only factors that could be verified in the distribution chain. FSIS

will also determine whether some adulteration and misbranding

inspections presently conducted in-plant can be supplemented or perhaps

performed entirely in-distribution. Many meat and poultry products are

prepared by regulated establishments in consumer-ready packages.

Samples could be collected in the marketplace rather than in

establishments and subsequently analyzed in a laboratory for product

formulation, proper labeling, and compliance with microbial and residue

standards. For example, samples could be taken in-distribution to

profile water added hams to determine adherence to accurate labeling

and restricted ingredients requirements. Similarly, products produced

in bulk packages might also be sampled at points in-distribution beyond

where it was initially processed.

In-Distribution Alternatives

Transportation and storage are vital links in the farm to table

continuum. The Agency has been developing in-distribution concepts and

identified both available information and information gaps. Allied

industries responsible for transportation and storage of meat and

poultry have addressed product integrity issues for sometime. For

example, cold storage facilities, warehouses, depots, and similar kinds

of businesses have temperature and product handling controls that they

use to ensure the safe storage of foods. Such standards may have broad

applicability to in-distribution activities. The details about these

activities, however, are not adequately known to FSIS.

FSIS identified several alternatives to ensure safe transportation

and storage of food in its ANPR of November 22, 1996: Transportation

and Storage Requirements for Potentially Hazardous Foods (61 FR 59372).

These alternatives include specific requirements, such as temperature

standards, performance standards, record keeping to ensure that food

safety controls are maintained, mandatory HACCP-type systems, voluntary

guidelines, and combined approaches. These alternatives are summarized

below.

1. Temperature Requirements

One approach is the promulgation of a performance standard that

would require that potentially hazardous foods be cooled to and

maintained at or below a specific temperature during transportation and

storage from the food processing plant to the retail outlet,

restaurant, or other establishment serving the consumer. If this

approach is adopted, all potentially hazardous foods being transported

to retail or food service establishments would have to be maintained at

or below such a maximum temperature.

2. Shipper Recordkeeping

Another alternative could be recordkeeping requirements with

respect to the conditions under which foods that pose a risk as

vehicles for foodborne disease are transported interstate. The Agency

may consider requiring carriers of potentially hazardous foods that are

shipped in bulk (foods which directly contact a food conveyance) to

provide food shippers with records that identify the last three cargoes

for any conveyance being offered to the food shipper for use in

transporting the food and that disclose the data of the most recent

cleaning of the conveyance.

3. Mandatory HACCP-Type Systems

Another approach would be to require that a HACCP system be

established specifically with respect to the transportation and storage

of potentially hazardous foods to prevent the contamination of these

foods. Such requirements could be modeled on the regulations recently

adopted by FSIS that apply to establishments processing meat and

poultry.

Such HACCP-type systems could be relatively simple. Essentially,

they would likely require that potentially hazardous foods be

maintained at a particular refrigeration temperature or frozen

temperature, and that the temperature be recorded using a recording

thermometer. The use of a temperature standard would allow processors

to determine the acceptability of a food transport vehicle for the

transport of certain bulk foods, i.e., those that pose a risk of

foodborne disease, based on cargo records.

4. Voluntary Guidelines

Another approach under consideration is to make more use of

voluntary guidelines. Some government agencies, industry groups, and

other organizations have published guidelines or recommended practices

that address the transportation and storage of potentially hazardous

foods, whether fresh or frozen. Such guidelines, several of which are

discussed in the ANPR of November 22, 1996 (61 FR 59372), could serve

as the basis for developing joint government-industry guidelines for

food transportation and storage.

V. Public Meeting

Public participation in the development and implementation of the

new inspection models discussed in this notice is essential. In

addition to commentary on FSIS resource redeployment, specific

inspection models, and in-distribution inspection activities, the

Agency believes that comments addressing the following questions will

facilitate the public process.

What are the priority food safety objectives that must be

accomplished by FSIS' meat and poultry inspection system?

What other significant consumer protections should the

meat and poultry regulatory system provide?

How should the agency prioritize food safety and other

consumer protection objectives?

How much emphasis should FSIS place on detection of

aesthetic defects that are not related to food safety?

A major objective of the S-SOP requirement in the PR/HACCP

regulation was to make establishments more accountable for performing

all necessary sanitation functions before

[[Page 31562]]

and during operations. What other establishment operations might

benefit from similar regulatory approaches?

Is it necessary or desirable to employ the same inspection

methodology in all similar establishments?

What roles should Federal, State, and local governments

play in verifying the safe transportation and storage of potentially

hazardous foods?

How we can best coordinate with State and local

authorities to minimize restaurant and institutional outbreaks linked

to meat and poultry products?

How can FSIS verify allied industry management of food

safety risks as meat and poultry products move from the establishment

to consumers?

What systems do establishments have in place for ensuring

in-distribution protection of meat and poultry products? How does

industry measure the performance of these systems?

What in-plant inspection objectives can be supplemented or

replaced with in-distribution inspection models?

What additional suggestions are there for data collection

efforts to be carried out in distribution channels?

Are the in-distribution alternatives identified in the

ANPR of November 22, 1996 (61 FR 59372), useful? In what ways?

Done at Washington, DC on: June 4, 1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97-15115 Filed 6-5-97; 3:26 pm]

BILLING CODE 3410-DM-P