[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Proposed Rules]
[Pages 54450-54457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26296]



 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 60, No. 205 / Tuesday, October 24, 1995 / 
Proposed Rules  

[[Page 54450]]


DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 308, 310, 318, 320, 325, 326, 327, and 381

[Docket No. 95-046N]


Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems--Issue Papers

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed Rule; issue papers.

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SUMMARY: On September 13-15, 1995 and September 27-29, 1995, the U.S. 
Department of Agriculture held issue-focused public meetings on the 
Food Safety and Inspection Service's (FSIS) proposed rule, ``Pathogen 
Reduction, Hazard Analysis and Critical Control Point (HACCP) 
Systems.'' At the meetings, FSIS made available issue papers on agenda 
topics. Those issue papers are published in this notice.

DATES: The comment period for the proposed rule, ``Pathogen Reduction; 
Hazard Analysis and Critical Control Point (HACCP) Systems'' (60 FR 
6674, February 3, 1995), which reopened August 11, 1995 (60 FR 41029 
August 11, 1995), will close, as announced in the Federal Register (60 
FR 45380, August 31, 1995), on October 30, 1995.

ADDRESSES: Send an original and two copies of written comments to: FSIS 
Docket Clerk, DOCKET 93-016P, Docket Room 4352, South Agriculture 
Building, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT: Dr. Paula Cohen, Director, Regulations 
Development, Policy Evaluation and Planning Staff, FSIS, USDA, Room 
3812, South Agriculture Building, Washington, DC 20250, (202) 720-7164.

SUPPLEMENTARY INFORMATION: The U.S. Department of Agriculture held 
issue-focused public meetings on September 13-15, and 27-29, 1995, on 
FSIS' proposed rule, ``Pathogen Reduction; Hazard Analysis and Critical 
Control Point (HACCP) Systems.'' The purpose of the meetings was to 
provide an opportunity for interested persons to directly discuss the 
key concerns that were raised during the comment period on the proposed 
rule, as well as the Agency's thinking about options under 
consideration in response to those concerns.
    For the meetings, FSIS prepared brief issue papers on agenda items 
that were discussed. The issue papers are: Issue Paper 1. ``Regulatory 
Shift to Performance Standards--`Layering';'' Issue Paper 2. ``Overview 
of HACCP Proposal FSIS Oversight of HACCP Changing Role of Inspectors 
Under HACCP;'' Issue Paper 3. ``Pathogen Reduction Performance 
Standards;'' Issue Paper 4. ``Carcass Cooling Standards for Red Meat 
and Poultry;'' Issue Paper 5. ``Specific Economic Considerations and 
Issues;'' Issue Paper 6. ``Specific Product Considerations Involving 
Religious, Ethnic, and Cultural Food Handling Practices;'' Issue Paper 
7. ``Antimicrobial Treatments in Slaughter Plants;'' and Issue Paper 8. 
``Specific Product Considerations Involving International Trade.''
    All information received at the issue-focused meetings and received 
during the reopened comment period will be considered in the 
development of the final rule for Pathogen Reduction/HACCP. FSIS is 
publishing the issue papers so they will be available to persons who 
were unable to attend the issue-focused public meetings and to enhance 
the opportunity for comments from all interested parties.
    The issue papers are published below.

Issue Paper 1. ``Regulatory Shift to Performance Standards--
`Layering'''

I. Objective of Proposal

    The goal of the Pathogen Reduction/HACCP Proposed rule is to adopt 
and implement an integrated, HACCP-based inspection system that 
clarifies and maintains a distinction between industry and FSIS 
responsibilities, targets the most significant hazards, and fosters 
flexibility, innovation and accountability for improving food safety. 
However, FSIS recognizes that to achieve this goal, it must also 
eliminate unnecessary and redundant regulations.

II. Description of Comments

    Some commenters argued that the proposed pathogen reduction and 
HACCP requirements layer an additional set of regulations, and 
subsequently an additional program of inspection, on the current meat 
and poultry inspection regulations and inspection activity. Some 
commenters recommended that, prior to publishing the final rule, FSIS 
review and revise or eliminate current regulations, directives, and 
other FSIS guidances so that they are compatible with the proposed 
pathogen reduction/HACCP requirements.
    Some commenters cautioned FSIS not to alter or eliminate current 
regulatory requirements and inspection procedures until more effective 
ones are operating in their place.

III. Issues Raised by Comments

    FSIS recognizes the need to articulate how regulatory requirements 
and inspectors' roles would change under the regulatory system that 
would emerge from the proposed regulatory reforms. Key issues of 
concern raised by the comments include:

     HACCP clarifies the mutually exclusive roles of 
industry and Government and, along with responsibility, affords 
individual plants the flexibility to innovate and make site-specific 
decisions. The current inspection system makes the inspector 
responsible for ``approving'' production-associated decisions. How 
will inspection change under HACCP?
     Under what circumstances will FSIS continue to issue 
command-and-control-type requirements?
     How should the regulatory system be changed, and at 
what pace, to eliminate redundant and obsolete requirements, such as 
prior approval systems and command-and-control requirements?
     Has FSIS identified the regulations that need to be 
eliminated or changed to be compatible with HACCP? Given that the 
current inspection system is embedded in current regulations, the 
essential changes are likely to be extensive. Can all necessary 
changes be adopted prior to HACCP implementation?
     Will inspectors' roles change as a result of the shift 
from step-by-step, command-and-control requirements to performance 
standards? How? How will the transition to the new regulatory 
system--with plants accountable for meeting FSIS's requirements by 
methods not necessarily listed in the regulations or inspectional 
guidelines--be managed?
     What methods of dispute settlement should be available 
to handle the more 

[[Page 54451]]
complex decisions that need to be made about compliance with 
regulations under HACCP?

IV. FSIS Current Thinking About Changes Needed to Address These Issues

    Under the proposal in conjunction with the regulatory reforms now 
in progress, industry would assume full responsibility for production 
decisions and execution, and FSIS, having set food safety standards and 
public health objectives, would monitor and enforce plants' compliance 
with those standards and related requirements and, under HACCP, would 
verify process control. This would appear to imply the following:

     FSIS must review and revise or eliminate current 
regulations, directives, and other FSIS guidances to ensure their 
compatibility with HACCP requirements and the regulatory philosophy 
HACCP represents.
     Performance standards could be used to eliminate 
certain command-and-control requirements.
     With the distinct roles and responsibilities of FSIS 
and industry clearly defined, FSIS would be able to relieve 
inspectors of many tasks that should be performed by establishments, 
enabling inspectors to focus on, HACCP-related oversight tasks.
     In-plant inspection would have to be managed so that 
the skills necessary to evaluate the plant's performance under HACCP 
would be available in every plant.
     Lines of FSIS supervision and decision making would 
need to be shortened, clarified, and publicized, particularly with 
respect to fair, prompt, and effective dispute resolution.
     Unnecessary and redundant regulations would need to be 
eliminated.

Issue Paper 2. ``Overview of HACCP Proposal FSIS Oversight of HACCP 
Changing Role of Inspectors Under HACCP''

I. Objective of Proposal

    The proposed rule embraced the recommendations of the National 
Advisory Committee on Microbiological Criteria for Food (NACMCF) 
concerning ``The Role of Regulatory Agencies and Industry in HACCP.'' 
Regarding food safety, the NACMCF advised that establishments operate 
effective HACCP systems, with the government focusing on verification 
that HACCP plans are working as intended. The Agency's stated intent 
was to review and revise existing inspection tasks to assure they are 
focused on the critical control points in HACCP plans. These revised 
tasks would be incorporated into the Performance Based Inspection 
System (PBIS) and become part of regular assignments.
    FSIS inspectors would play a verification role to ensure that 
appropriate HACCP plans are in place, are being implemented properly, 
and are achieving the desired food safety results. This role would 
require increased activity by FSIS inspectors in the areas of record 
review, visual process verification, and product sampling. FSIS 
inspectors would have to develop new skills to carry out these 
activities within the HACCP framework.

II. Description of Comments

    Commenters generally supported the need for government to maintain 
oversight of meat and poultry production to ensure that industry is 
using a system of process control that assures safe product. Some 
commenters stated government needs to relinquish at least some of the 
role it plays in making decisions about the production process itself; 
that is, industry should have the responsibility for deciding how meat 
and poultry products are produced, provided it can demonstrate that it 
is maintaining process control at the level necessary to produce a safe 
product, and meets other regulatory requirements. There was general 
support for HACCP as an acceptable industry process control mechanism, 
though commenters raised a number of issues concerning specific 
provisions of the proposed rule. Some commenters stated government 
requirements should be scientifically supportable and stated as non-
prescriptively as possible (as performance standards).
    Commenters also raised concerns about the amount of discretion 
inspectors would have to suspend plant operations due to alleged 
deficiencies in either the design or operations of a HACCP plan. They 
expressed concern about the limited amount of procedural due process 
afforded to establishments faced with suspended operations due to an 
inspector's judgment on the adequacy of their HACCP program. Some 
commenters objected to the proposed hearing process and requested a 
more expedient way to resolve disputes before requiring suspension of 
operations or withdrawal of inspection. Some urged the Agency to make 
clear to inspectors that such extreme actions are to be reserved for 
only those situations in which continued operation of the establishment 
presents an imminent public health risk. Finally, commenters raised 
questions concerning the uniformity and depth of HACCP training 
inspectors should receive.
    Some commenters, while supporting the enhancement of industry's 
responsibility for food safety that is embodied in HACCP and 
performance standards, expressed concern about how plants would be held 
accountable for meeting their enhanced food safety responsibilities. 
These commenters called for vigorous inspectional oversight of HACCP 
including substantial microbial sampling and testing by FSIS to verify 
HACCP and enforce performance standards. Some commenters called for 
retaining current inspection procedures until HACCP is implemented and 
FSIS can have confidence that alternative procedures will be more 
effective than current ones. To increase industry accountability, some 
commenters called for clear delineation of the plant's legal 
obligations under HACCP, public access to HACCP records, and 
whistleblower protection for plant and FSIS employees.

III. FSIS Current Thinking on Selected Issues

    FSIS recognizes the need to articulate in more detail how FSIS 
oversight of meat and poultry production operations under a HACCP 
process control system will change, how FSIS regulatory roles will be 
altered, and how these changes will affect inspectors' roles. The 
following issues must be addressed to develop and implement a final 
rule:

     How will FSIS oversee a plant's operation under HACCP, 
compared with the current system.
     How should inspector roles be changed to distinguish 
between industry and government responsibilities.
     How should the inspector's role and priorities be 
redefined to focus on the greatest public health risks.
A. Transition to a System Focusing on Industry Process Control and 
Other Systems and Safety Standards
    The regulatory environment envisioned by the proposed rule, in 
which industry would operate under a process control system (HACCP) and 
inspection personnel would ensure that HACCP is working by overseeing 
the effectiveness of that process control system in producing safe 
product and by enforcing performance standards and other requirements, 
calls for a significant shift in FSIS oversight. This shift would focus 
regulatory activities on process control and other systems and the 
enforcement of government safety requirements (to the extent possible 
issued as performance standards) rather than on prescriptive measures 
for controlling industry production practices.
    The implementation of the proposed requirements would significantly 
change the roles and responsibilities of Agency personnel performing 
in-plant 

[[Page 54452]]
regulatory activities. Inspection roles and responsibilities would 
shift from DETECTING facility and production problems to VALIDATING and 
VERIFYING that plants are producing safe meat and poultry products that 
meet the newly established requirements.
    Agency activities and individual inspectors' tasks would need to 
reflect these proposed new requirements, and would need to be timed to 
conform to the phase-in schedule for the new requirements. During the 
transition from the current inspection system to the system envisioned 
by the proposal, it would be critical to provide for an interface 
between what FSIS is presently doing and what the Agency would be doing 
when initial implementation of these requirements occurs. Therefore, 
FSIS' current thinking about how inspection will change entails 
determining how existing and familiar systems may be used to support 
the transition, while the Agency prepares inspectors and supervisors 
for their changed roles under the new program.
    Inspection roles are envisioned to consist of three primary 
activities--validation, verification, and enforcement. Inspection 
validation activities would include assessments of whether plants 
comply with the specific elements of the regulation and that HACCP 
systems encompass all seven HACCP principles. Inspection verification 
activities would include an evaluation of records to verify that the 
establishment is complying with its written HACCP plan along with in-
plant visual observations, microbial testing, and other inspectional 
tasks to ensure that HACCP is being properly implemented and 
performance standards are being met.
    Formal enforcement actions, including retention of products or 
suspension of operations, would be instituted when inspection personnel 
identify and document occurrences of direct product contamination, 
insanitary conditions where the product may have become adulterated or 
contaminated or where it may have been rendered injurious to health, or 
failure of the HACCP plan. Lines of supervision and decisionmaking 
would be shortened and clarified with respect to dispute resolution. 
FSIS recognizes that the appeal process must be more expeditiously 
handled under the proposed program.
    Inspection activities would be accomplished within the framework of 
existing support systems. For example, the Performance Based Inspection 
System (PBIS) would serve as the primary vehicle to schedule, record, 
and report all validation and verification tasks. The PBIS corrective 
action system, which consists of the deficiency classification guide 
and process deficiency record, would be used to identify, document, and 
act upon occurrences of direct product contamination and system 
failures. The system would be modified to incorporate all slaughter-
related activities, except carcass-by-carcass inspection.
    The movement to a HACCP work environment would represent the most 
significant change to the regulatory process in the history of the 
inspection program. This would require that the field work force be 
trained to understand and perform new work tasks and to adapt to the 
changing regulatory focus. The initial training would focus on three 
aspects--(1) to equip employees to handle the regulatory tasks 
associated with the near term initiatives such as verifying the SOP 
records; (2) to equip employees to understand and appreciate the 
cultural changes that will take place in a HACCP work environment its 
effects on their actions; and (3) to equip front line supervisors to 
lead the cultural change. Subsequent training would be provided on a 
sequential basis to correspond with the HACCP phase-in schedule. In 
this way, inspectors would be able to directly apply ``just learned'' 
knowledge and procedures within days of receiving training. Training 
would be delivered by Agency personnel at the local level, using 
standardized materials developed expressly for that purpose.
    FSIS shares the objective of some commenters of ensuring that 
inspectors and plant employees are given a common understanding and 
approach to HACCP and its application to meat and poultry production. 
However, FSIS believes it must place full reliance on its inhouse 
training delivery capabilities rather than participate in joint 
training sessions with industry personnel at the local level. Given the 
logistics and timeframes involved in training Agency personnel, the 
Agency could not accommodate the additional burden of coordinating its 
training delivery activities with industry. FSIS is, however, committed 
to sharing its curricula with interested parties, in order to ensure 
that the scientific and technical principles which undergird HACCP are 
viewed consistently.
B. Other Changes Beyond the Transition to HACCP
    Along the farm-to-table continuum there are several opportunities 
for Federal, State, and local government regulators to foster or 
establish standards so industry can reduce the possibilities for 
product adulteration and subsequent foodborne illness.
    For animal production, producer associations could promote the 
development of quality assurance programs that focus on risk reduction 
strategies for pathogen control in live animals. Further research by 
government, industry, and the scientific community is also necessary to 
acquire the scientific information about pathogen colonization, its 
characterization, prevalence, and incidence in animal populations, 
which is necessary for designing effective intervention programs.
    For transportation and storage, industry associations could 
promote, and individual transportation and storage firms could adopt, 
special systems for handling meat and poultry that ensure minimal 
growth of pathogenic organisms. Development of Good Manufacturing 
Practices (GMP's) for this sector to address problems such as 
sanitation and temperature control and periodic reviews to determine 
conformance with such GMP's are also envisioned. These reviews would 
provide the basis for determining rates of industry compliance.
    In the retail and restaurant sector, FSIS would continue its 
ongoing, direct regulatory authority over adulterated and misbranded 
product. This would include product control actions, such as voluntary 
destruction, detention, and judicial seizure. It also would include the 
issuance of letters of warning and referrals to the Department of 
Justice for injunctions or criminal action.
    FSIS would expand its support to State and local inspection and 
enforcement agencies by: (1) Supporting the development and adoption of 
model food codes; (2) facilitating the standardization of state and 
local enforcement protocols in concert with the Food Code; and 3) 
evaluating state and local food regulatory agency inspection and 
enforcement programs for meat and poultry processing and handling.
    In the area of food handler and consumer education, FSIS would 
continue its current program and would seek ways to expand its 
collaboration with all interested parties in government, industry and 
other private organizations to foster the effective delivery of safe 
handling messages to consumers in a manner that would improve safe food 
handling practices. 

[[Page 54453]]


Issue Paper 3. Pathogen Reduction Performance Standards Microbial 
Testing

I. Objective of Proposal

    The objective of the proposed interim targets for pathogen 
reduction and daily microbial testing requirement is to establish a 
measure of accountability for adopting process controls in slaughter 
plants and plants producing raw ground product that effectively control 
and reduce harmful bacteria on raw products. Salmonella has been 
selected in the proposed rule to serve as both an indicator of process 
control and as the basis for a pathogen-reduction performance standard.

II. Description of Comments

    The two issues most commonly addressed by the commenters concerning 
the proposed microbial testing requirements were the proposed selection 
of Salmonella as the indicator organism and the frequency of proposed 
testing. Commenters generally supported the concept of HACCP-based 
process control and the goal of reducing harmful bacteria on raw 
products.
    Some commenters supported the proposed use of Salmonella as the 
indicator organism because it is a leading cause of foodborne illness, 
and, among common enteric pathogens, it is among the most prevalent and 
relatively simple tests are available to detect it.
    Some commenters opposed the use of Salmonella as the indicator 
organism because its low incidence in beef makes it a poor indicator of 
pathogen reduction in that species; the yes/no test result is a weak 
measure of process control; and, compared to some non-pathogenic 
alternatives such as generic E. coli, Salmonella tests are more 
difficult, time-consuming and costly. Some commenters recommended FSIS 
consider an alternative indicator organism such as generic E. coli as a 
preferable process control indicator organism because it can serve 
effectively in all species as an indicator of fecal contamination.
    Some commenters recommended retaining Salmonella as the target or 
performance standard for pathogen reduction but adding a requirement 
for E. coli testing because it is a preferable tool for verifying 
process control. Some commenters recommended requiring testing for 
additional pathogens in selected species or products based on the 
degree of public health risk posed by the pathogen. With regard to 
sampling frequency, some commenters supported the one sample per day 
testing requirement as an efficient means of verifying process control.
    The comments received on the frequency of testing centered upon 
suggestions on the sampling frequency of one test per day for each 
species and for raw ground product. A sampling protocol based on 
production volume or product risk was suggested as an alternative. Some 
commenters opposed the proposed testing requirement stating that it was 
inadequate to verify process control reliably and recommended more 
frequent testing that would be more representative of a plant's 
production. Some commenters recommended basing the frequency of testing 
on a plant's volume of production and argued that the proposed sampling 
frequency and moving sum statistical procedure would allow a lack of 
process control to go undetected for excessive periods.
    Some commenters criticized the proposed frequency, noting the cost 
burden of the testing and its financial impact on businesses, 
especially for small volume plants and plants producing multiple 
species and multiple ground products that would require multiple tests. 
Some commenters recommended less than daily testing or other changes to 
minimize the financial impact on small business.
    Some commenters objected to the proposed test sample collection 
methodology, including the sample size. Recommendations included 
adopting the same sample size for all species. Some commenters 
preferred swab samples to samples taken by knife cuts.
    Some commenters stated that proposed end product testing is 
inconsistent with HACCP principles and that establishments should 
decide for themselves through hazard analysis whether testing is needed 
and at what frequency.

III. FSIS Current Thinking on Selected Issues

    The concepts of process control, microbiological testing to verify 
process control, and the establishment of practical measures of 
accountability for controlling and reducing harmful bacteria on raw 
products remain central to the FSIS food safety strategy. Based on the 
comments related to microbial testing, FSIS reviewed whether the 
pathogen reduction objectives of the rule can be accomplished without 
requiring near-term microbial testing. FSIS considers some appropriate 
approach to testing to be necessary as the means of ensuring that every 
establishment is working toward an acceptable level of pathogen 
control. The key issues raised by the comments involve how best to 
implement these concepts.
    Relative to concerns about reducing the burden of testing, the 
Agency is reviewing: (1) The organism to be selected in testing; (2) 
the necessity for daily testing in every plant, including plants that 
grind raw meat and poultry obtained from other plants and (3) the 
necessity for testing each species slaughtered and each ground product 
produced.
    The proposed rule relied on Salmonella as both a process control 
indicator and as the basis for a pathogen reduction performance 
standard applicable to all species. Based on the comments, FSIS is 
seriously considering generic E. coli as the process control indicator 
organism and the adoption of a quantitative E. coli standard as a 
measure of process control with respect to the prevention and reduction 
of fecal contamination in slaughter plants.
    If FSIS moves to a quantitative E. coli standard as the means of 
verifying process control, the Agency will also need to resolve what 
the standard should be (i.e., the number of organisms).
    FSIS continues to regard microbiological testing to verify process 
control to be an establishment's responsibility. FSIS is reconsidering 
the proposed one test sample per day requirement based on comments 
questioning both its adequacy and its cost impact on small plants. FSIS 
is considering alternatives that are based on the volume of production. 
FSIS is also considering alternatives that would reduce the cost impact 
of testing on very small-volume plants producing multiple species and 
multiple products.
    FSIS is considering the adoption of pathogen-specific performance 
standards as a direct measure of accountability for controlling and 
reducing harmful bacteria on raw meat and poultry products. For 
example, the proposed interim targets for pathogen reduction based on 
Salmonella (or possibly other pathogens for specific species) could be 
adopted as performance standards and enforced by FSIS through its own 
compliance monitoring. Establishments not consistently achieving the 
targets would be required to take corrective action and could be 
subject to other regulatory action, as appropriate.

Issue Paper 4. Carcass Cooling Standards for Red Meat and Poultry

I. Objective of Proposal

    The objective of the proposed carcass-cooling requirements as a 
near-term measure in the Pathogen Reduction/HACCP proposed rule is to 
ensure that establishments effectively control the 

[[Page 54454]]
growth of pathogens on meat and poultry carcasses.

II. Description of Comments

    Commenters generally supported the need for slaughter plants to 
chill carcasses as a means of minimizing the growth of harmful 
bacteria, but some commenters questioned the need for any new near-term 
regulatory requirements for carcass cooling. These commenters 
recommended instead that plants address carcass cooling as part of 
their HACCP plan at the time they implement HACCP. Some commenters 
opposed the ``command and control'' nature of the proposed requirements 
and said that relying instead on the incorporation of time and 
temperature controls in a plant's HACCP plan would provide maximum 
flexibility to adopt controls consonant with different products and 
environments.
    Some commenters raised concerns about the specific time and 
temperature requirements in the proposed rule. Other comments included 
the pros and cons of surface versus internal temperatures as indicators 
of coldness. Some commenters supported the time and temperature 
requirements as proposed, noting that these controls are designed to 
minimize the potential multiplication of bacterial pathogens in 
carcasses and raw meat products and thus reduce consumer exposure to 
pathogenic bacteria. Some pointed out that the technology is available 
and generally being used in plants and that, furthermore, the proposed 
time and temperature controls are generally being adhered to by many 
establishments and therefore should not be an overwhelming burden. 
These commenters stated that the cooling rate proposed by FSIS is based 
on the best estimate of what is needed to minimize multiplication of 
pathogenic organisms and what is achievable in a well-controlled meat 
and poultry establishment.
    Some commenters raised concerns about not having the cooling 
capacity to comply with the proposal and about the prohibitive cost of 
obtaining the necessary refrigeration equipment. Commenters advocated 
more realistic requirements that take into consideration plant/product 
variety, different processing operations, and diverse shipping and 
receiving norms. Commenters raised questions about disposition of 
product that did not meet temperature requirements.
    Some commenters expressed concern about health problems that could 
result among their employees from working in a cold environment. 
Comments related to worker comfort and safety cited studies that 
concluded many human physical ailments are created or aggravated by 
cold temperatures. Worker safety was also cited as an issue on the 
ground that the difficulty of handling and cutting meat at such cold 
temperatures increases the potential for accidents.

III. FSIS' Current Thinking on Issues Raised by Comments

    FSIS considers carcass cooling to control growth of pathogens to be 
a basic element of a safe food production process. Poultry slaughter 
plants are currently subject to an FSIS directive on carcass cooling, 
and many beef slaughter plants take appropriate measures to cool 
carcasses. FSIS continues to believe there is a need before and after 
implementation of HACCP for the establishment of some basic standards 
that can be used to ensure all plants meet carcass cooling standards.
    FSIS recognizes the need to take a practical approach that 
acknowledges the diversity of production practices affected by carcass 
cooling requirements. FSIS is considering more flexible alternatives to 
the time and temperature requirements in the proposed rule, including 
adoption of pathogen growth performance standards (see options below).
    FSIS acknowledges the need for a clarification of product 
disposition options for product that does not meet carcass cooling 
requirements. This remains under consideration.

IV. Options for Change

    In addition to the currently proposed requirements, FSIS is 
considering the following options:

     Maintain the proposed requirements but raise the 
40 deg.F criterion to the highest level that would maintain the 
pathogen control objective and address at least some concerns about 
worker comfort and safety and equipment costs. The European Union, 
for example, uses a 44.6 deg.F standard for red meat to control 
pathogens during slaughter operations.
     Establish a carcass cooling performance standard 
expressed as a maximum acceptable level of pathogen growth.
     Rely on microbiological targets, such as the proposed 
interim targets for pathogen reduction, as performance standards, 
monitored by periodic microbial testing, and have no specified 
cooling requirements. This option would provide establishments 
flexibility to use carcass cooling methods that meet their own needs 
as long as they meet the end product performance standard.

Issue Paper 5. Specific Economic Considerations and Issues

I. Objective of Proposal

    The Pathogen Reduction/HACCP proposal acknowledged that the 
proposed requirements would have significant economic impact, 
particularly on small entities. Comments were requested on cost 
estimates for these impacts as well as on alternative regulatory 
approaches that could lessen this economic impact.

II. Description of Comments

    Several themes emerged from the written comments received and oral 
statements made during public meetings on the Pathogen Reduction/HACCP 
proposed rule. A primary concern was that the proposal would have 
severe negative economic impacts on small businesses. Some commenters 
opposed mandatory HACCP, daily microbial testing, and stringent time 
and temperature requirements.
    While most commenters supported HACCP in principle, small 
businesses expressed concern about hazard analysis and plan development 
costs, equipment purchases, plant personnel training, and records 
maintenance. Suggested alternatives included voluntary HACCP, a 5-year 
implementation period, increased financial and technical support, 
alternative training options, inplant demonstration projects and 
generic HACCP plans.
    Daily microbial testing of carcasses from each species slaughtered 
and of each type of raw ground product was cited as an unfair burden on 
small plants that slaughter only a few animals, a variety of species, 
or produce several different raw ground products. Some commenters 
proposed a frequency of microbial testing based on production volume or 
simply once per week or month in small plants. It was also suggested 
that federally-subsidized laboratories conduct the testing, an 
indicator organism instead of Salmonella be selected, and that either 
FSIS inspectors or, in the case of State-inspected plants, State 
inspectors conduct the sampling.
    In response to the proposed carcass cooling time and temperature 
mandates, small businesses voiced a need for more realistic standards 
that reflect small plant product variety, processing operations, and 
shipping norms. Some said they would need to purchase additional 
refrigeration equipment for compliance with the proposed requirements. 
Others cited the ``command and control'' nature of these proposed 
standards and argued that 

[[Page 54455]]
they are impractical restrictions on a variety of their operations. A 
common theme was that these proposed controls should be restated as 
guidelines.
    Commenters also voiced economic objections to the antimicrobial 
treatments and asked for greater scientific justification. Comments 
also included cautions about worker safety and environmental hazards, 
and requested a change from mandatory to voluntary implementation.
    Some commenters asserted that within the small plant category is a 
subgroup of State-inspected plants with the same concerns as those 
stated above and additional ones due to their very small size and 
diverse operations. These commenters requested identification of a 
``very small'' sub-category of plants defined as those with annual 
sales less than $1 million, fewer than 20 employees and limited 
production volume. Exemptions and implementation delays were requested 
for plants in the proposed ``very small'' category.
    Another issue raised was State-provided implementation assistance 
for State-inspected plants and whether matching Federal funds would 
cover State programs that provided more help than USDA regulations 
required.

III. Issues Raised by Comments

    After reviewing the small business concerns expressed in the 
comments, FSIS is considering whether the food safety and public health 
objectives of this proposal can be accomplished by means that would 
reduce the regulatory burden and resulting costs of the proposed 
requirements on small businesses.
    FSIS continues to believe that mandatory HACCP is central to the 
FSIS food safety strategy and reform of the meat and poultry inspection 
system. Given this, can FSIS significantly reduce the economic impacts 
on small business by any of the generally applicable modifications to 
the proposed rule or by using its available resources to provide 
implementation assistance?
    For example, small business objections to the burden of daily 
microbial testing of each species and ground product for Salmonella 
require FSIS to determine whether another microorganism, reduced 
frequency of testing, and/or FSIS assumption of a greater testing role 
would be equally effective in verifying process control and attaining 
pathogen performance standards and, at the same time, reduce the 
economic burden.
    Raw product time and temperature specifications and antimicrobial 
treatments for carcasses are techniques for pathogen reduction that 
have been criticized as command-and-control regulatory approaches. FSIS 
is considering whether these proposed requirements can be replaced by a 
performance standard or otherwise modified to achieve the food safety 
objectives while mitigating the economic burden on industry, including 
small plants.
    After publication of final Federal meat and poultry Pathogen 
Reduction/HACCP regulations, all State inspection programs must 
establish requirements at least equal to the Federal requirements. Due 
to variations in State regulatory processes, some intrastate inspection 
programs may match the Federal regulations within a year while others 
may take two years in cases where inspection program regulations must 
be approved by the State legislature. Once new regulations are in 
place, State plants would have to be given adequate time to meet the 
new requirements. In particular, State implementation of the near-term 
initiatives would likely occur on a longer time line than that proposed 
for Federal plants. FSIS is considering ways to minimize any inequity 
between Federal and State-regulated plants.
    Another State-specific concern relates to Federal matching funds 
for up to 50 percent of State inspection program budgets. The HACCP 
proposal raises questions about what activities will be covered by 
matching funds. For example: If State inspection programs provide HACCP 
training for industry employees in State plants, assist State plant 
owners in HACCP plan development and implementation, or offer ongoing 
technical assistance to State plant operators, can/shall Federal 
matching funds be provided?
    A further question is whether certain small businesses should be 
separately identified from others by defining a new ``very small'' 
business category. Available data indicate, for example, that among all 
state-inspected plants, approximately 75 percent employ fewer than 8 
employees. Given the likelihood of longer implementation times for most 
intrastate plants due to the normal process of State compliance with 
Federal inspection program changes, is there a reasonable justification 
for longer times for all such ``very small'' plants in terms of 
attainment of national pathogen reduction and process improvement 
requirements?

IV. FSIS' Current Thinking on Issues Raised by Comments

    To address small business concerns, FSIS proposes to use a three-
part regulatory policy that would apply to every Federal and State-
inspected plant: (1) Fundamental public health and food safety 
principles must not be compromised, (2) Regulatory flexibility will be 
provided to plants by establishing performance standards, and (3) 
Direct and indirect assistance will be provided by FSIS to small plants 
that need help in reaching those goals.
    FSIS is considering appropriate regulatory flexibility options that 
would minimize small business impacts as they attain performance goals. 
In the other issue papers on carcass cooling requirements, 
antimicrobial treatments, and microbial and testing standards, FSIS has 
outlined alternatives that could mitigate both the technical and 
economic considerations raised by small businesses about these proposed 
requirements. Remaining concerns to be addressed are focused on the 
HACCP implementation schedule and technical assistance.

HACCP Implementation Schedule

    As noted above, FSIS is considering ways to adjust the 
implementation schedule to ensure that small businesses under Federal 
regulation and those under State regulation are treated equitably with 
respect to the time period allowed for compliance with the provisions 
of the final rule.

HACCP Implementation Assistance

    Federal Assistance to Industry: FSIS is considering a program to 
develop implementation aids that should greatly reduce the uncertainty 
small plants have expressed about a mandatory HACCP program. These aids 
would include: (1) Information publications, such as a HACCP Handbook 
that explains how a plant can effectively and economically incorporate 
the seven HACCP principles into its operations; (2) training videos and 
computer programs that present HACCP implementation guidance in 
alternative formats; (3) models for onsite HACCP training of plant 
employees; and (4) a catalog of hazards with examples of control 
measures and generic plans for each slaughter and processing category 
described in the proposed rule. These materials would provide the means 
for all plants to meet HACCP regulatory requirements. FSIS is also 
planning to sponsor inplant demonstration projects to generate real-
world information and guidance about near-term and HACCP implementation 
issues in small businesses.
    Federal Assistance to States: FSIS would continue its technical 
assistance to State programs by including State training officials in 
Federal training efforts, by facilitating State access to and 

[[Page 54456]]
use of Federal computer support systems, and by expansion of state/
federal cooperative efforts through the Conference for Food Protection, 
the National Association of State Departments of Agriculture, the 
Association of Food and Drug officials, and the Meat and Poultry 
Inspection Advisory Committee. Also, FSIS' plans for inplant 
demonstration projects referenced above would focus on small plants 
under State regulation as well as those under Federal regulation.

Issue Paper 6. Specific Product Considerations Involving Religious, 
Ethnic, and Cultural Food Handling Practices

I. Objective of Proposal

    The objective of the Pathogen Reduction/HACCP proposed rule is to 
take a comprehensive approach to improving the safety of meat and 
poultry products.

II. Description of Comments

    Many commenters identified unique product considerations that they 
felt were threatened or undermined by certain requirements in the 
proposed rule. These unique product considerations principally involved 
religious, ethnic, and cultural issues centered around three product 
types: kosher products, Chinese poultry, and ``hot'' specialty items 
usually for Moslem, Chinese, Hispanic, and Hawaiian markets.
    Comments related to kosher products identified two specific areas 
of concern. First, antimicrobial treatments would cause a serious 
problem under kosher dietary laws if applied before the salting process 
and would cause practical problems if applied after the salting 
process. Second, the time and temperature requirements for carcass 
cooling might significantly shorten the available time for ritual 
salting, particularly for religious holidays, which might limit the 
availability of kosher meat. For these reasons, commenters requested 
exemptions from using antimicrobial treatments and from following 
proposed time and temperature requirements for meat and poultry 
products that are certified and sold as kosher.
    The Chinese-American community expressed concern about the added 
cost of whole birds prepared for religious purposes. Commenters 
requested an exemption for such products.
    Other commenters noted that proposed time and temperature 
requirements for carcass cooling conflict with ``hot pork,'' a process 
during which hogs are slaughtered and delivered to customers in some 
ethnic markets with little or no chilling. A similar process is used 
with lamb, goat, and beef for Moslem customers. An exemption was also 
requested for these products.

III. FSIS' Current Thinking on Issues Raised by Comments

    FSIS is examining how it can provide the regulatory flexibility 
needed to adequately address the concerns noted above and still achieve 
its food safety and public health objectives.
    FSIS expects the final rule to contain changes that will as a 
general matter increase industry's flexibility to use alternative 
technologies and procedures which reduce and control pathogens to meet 
the microbial performance standards. This approach may help address 
some of the concerns expressed by religious and cultural groups. If any 
individual group's unique problems are not adequately addressed by this 
approach, the agency would consider other alternatives that respect 
well established religious, ethnic, and cultural practices as much as 
possible while assuring fundamental public health and food safety 
objectives are achieved.

Issue Paper 7. Antimicrobial Treatments in Slaughter Plants

I. Objective of Proposal

    The objective of the proposal in the Pathogen Reduction/HACCP 
proposed rule, to require the application of at least one effective 
antimicrobial treatment in slaughter plants, is to establish a minimum 
standard of care regarding the use of available technology to reduce 
pathogens on carcasses leaving slaughter plants and to gain a net 
reduction in the occurrence of pathogens on carcasses in the near term, 
while HACCP is being implemented.

II. Description of Comments

    Some commenters supported the proposal to mandate the use of at 
least one antimicrobial treatment, subject to reservations concerning 
the effectiveness of the available treatments for specific pathogens, 
the possibility of cross-contamination, and the need to maintain 
careful, hygienic slaughter practices.
    Some commenters opposed the proposed antimicrobial treatments, 
raising concerns about the ``command and control'' nature of the 
proposal and the lack of sufficient empirical data to justify mandatory 
antimicrobial treatments.
    To alter the ``command and control'' nature of the proposal, some 
commenters recommended eliminating the formal approval process for 
antimicrobial treatments and allowing any treatment that meets stated 
conditions (such as, ``meets a pathogen reduction standard,'' ``does 
not adulterate product, create insanitary conditions, or result in 
misbranded product.'') Other suggestions included accepting irradiation 
and salt as antimicrobial alternatives. Some commenters stated that use 
of antimicrobial treatments should be a control measure plants consider 
during HACCP plan development, not before.
    Some commenters noted that certain foreign countries do not permit 
antimicrobial treatment of meat and poultry products. Acknowledging the 
proposed exemption for exported product included in the proposed rule, 
commenters still expressed concern that it was impractical for a 
slaughter operation to separate domestic and export product.

III. FSIS' Current Thinking on Issues Raised by Comments

    FSIS continues to believe antimicrobial treatments in many 
slaughter plants play an important role in a pathogen reduction 
strategy. FSIS is reconsidering whether the proposed across-the-board 
mandate is the optimal approach to fostering adoption of appropriate 
antimicrobial technologies or whether more flexible alternatives, 
including reliance on end-product performance standards, would be 
equally or more effective.

IV. Options for Change

    FSIS is considering the following possible alternatives to the 
proposed antimicrobial treatment requirements:

     Adopt the near-term requirement for slaughter 
establishments to apply an antimicrobial treatment to meat and 
poultry carcasses, with modification of some technical details (such 
as timing application, and proposed requirements for ensuring the 
efficacy of specific treatments).
     Adopt the near-term requirement for slaughter 
establishments to apply an antimicrobial treatment to meat and 
poultry carcasses, with modification of some technical details (such 
as timing application, and proposed requirements for ensuring the 
efficacy of specific treatments), but add an exemption option for 
plants that can demonstrate near-term compliance with process 
control and/or pathogen reduction performance standards.
     Do not require establishments to apply an antimicrobial 
treatment to meat and poultry carcasses, but rely instead on 
appropriate identified performance standards and microbial testing 
for generic E. coli, Salmonella or other pathogens as an incentive 
to maintain good sanitation and hygienic slaughter practices and to 
adopt 

[[Page 54457]]
technologies appropriate for achieving standards in particular plants.

Issue Paper 8: Specific Product Considerations Involving International 
Trade

I. Objective of Proposal

    The objective of the Pathogen Reduction/HACCP proposed rule is to 
take a comprehensive approach to improving the safety of meat and 
poultry products while recognizing international agreements.

II. Description of Comments

    Many commenters identified individual situations involving imported 
and exported products that they believe were potentially threatened or 
undermined by certain requirements in the proposed rule.
    Commenters involved in the export of meat and poultry products 
raised objections to the proposed antimicrobial treatment requirements. 
They stated that European Union (EU) countries would not accept product 
treated with antimicrobial agents and that Canada would not accept 
product treated with chlorine at the levels required in the proposal. 
They recommended that FSIS accept Codex Alimentarius standards in lieu 
of those in the proposed rule. Commenters also explained that the 
proposed exemption for exported product was insufficient to address the 
realities of slaughter operations which make separation of domestic and 
export product impractical.
    Questions were also raised about the requirements for foreign 
plants exporting meat and poultry product to the U.S. Commenters 
inquired if all foreign plants exporting products to the U.S. would be 
required to have HACCP systems, and if so, how would FSIS ensure 
compliance. Some commenters asked for clarification of ``equivalent 
standards'' language. They were concerned that domestic producers would 
be at an economic disadvantage if foreign competitors did not have to 
implement HACCP to sell product in the U.S.

III. FSIS' Current Thinking on Issues Raised by Comments

    After reviewing the comments relating to specific product 
considerations, FSIS is examining how it can provide the regulatory 
flexibility needed to adequately address the concerns noted above, meet 
the requirements of international agreements and still achieve its food 
safety and public health objectives.
Export Issues
    The EU member states and Canada are the only countries, to our 
knowledge, which restrict the use of antimicrobials on meat and poultry 
carcasses
    Plants producing meat and poultry for export to the EU or Canada 
can choose to treat carcasses with hot water, which is currently 
recognized by FSIS, the EU and Canada as an acceptable antimicrobial 
treatment when applied at 165 deg.F for at least 10 seconds. Use of 
this particular treatment would also preclude the need to segregate 
product.
    FSIS is also considering alternative approaches for achieving the 
same objective sought from antimicrobial treatments. Please refer to 
the previously distributed paper entitled ``Antimicrobial Treatments in 
Slaughter Plants.'' These alternatives, such as microbial performance 
standards, were discussed during earlier sessions of the public 
meetings. However, FSIS recognizes that during consideration of these 
approaches, the issues related to trade must be addressed.
Import Issues
    As a signatory to the NAFTA and GATT agreements, the United States 
has agreed to permit the importation of meat and poultry products from 
countries which operate inspection systems judged to be equivalent to 
that of the United States.
    The FSIS current thinking is that countries importing meat and 
poultry product to the United States would need to: 1) adopt 
performance standards which achieve levels equivalent to those of the 
United States, (e.g., microbial targets, chemical tolerances, economic 
adulterant limits (e.g., excess moisture), aesthetic defect limits 
(e.g., organ remnants), and 2) insure that process control systems 
equivalent to HACCP are utilized in the plants in order to meet U.S. 
performance standards and other regulatory requirements.
    FSIS is currently engaged in the process of developing criteria 
which it will use to determine if foreign plants engaged in export to 
the United States are utilizing process control systems equivalent to 
HACCP. FSIS recognizes that societal, cultural, economic and other 
conditions are not exactly the same in foreign countries as those in 
the United States and that effective process control systems may vary 
from country to country.
    Officials from some countries have proposed that their plant's 
current systems of process control which rely heavily on government 
intervention, control, and oversight are the most cost-effective way 
for their society and will result in product in full compliance with 
U.S. standards. Officials from other countries indicate they plan to 
require plants to use process control systems virtually identical to 
those being proposed by FSIS. As FSIS moves to establish appropriate 
criteria for judging equivalency, it will consider the various aspects 
of these alternative methods of assuring process control as compared to 
HACCP.
    In summary, the current FSIS thinking revolves around (1) 
establishment of objective, science-based performance standards and (2) 
evidence that systems of control equivalent to those used in the United 
States are in place to insure compliance with the standards. Again, 
FSIS recognizes that during the consideration of these approaches, the 
issues related to trade must be addressed.

    Done at Washington, DC, on October 18, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-26296 Filed 10-23-95; 8:45 am]
BILLING CODE 3410-DM-P