[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]
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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
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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
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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