[Federal Register Volume 62, Number 111 (Tuesday, June 10, 1997)]
[Notices]
[Pages 31553-31562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15115]


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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

[[Page 31554]]

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\
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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 
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\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
                                                                                 -------------------------------
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\
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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