[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Proposed Rules]
[Pages 26892-26900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12352]
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Proposed Rules
Federal Register
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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. 64, No. 95 / Tuesday, May 18, 1999 / Proposed
Rules
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317, 318, 319, and 381
[Docket No. 97-001P]
RIN 0583-AC35
Elimination of Requirements for Partial Quality Control Programs
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the meat and poultry products inspection regulations by removing
the requirements pertaining to partial quality control (PQC) programs
except with respect to the irradiation of poultry products. A PQC
program controls a single product, operation, or part of an operation
in a meat or poultry establishment. The proposal would remove the
design requirements for PQC programs and the requirements for
establishments to have PQC programs for certain products or processes,
other than those that apply to irradiation of poultry products. For
example, the proposal would remove the requirements for poultry
slaughtering establishments operating under the New Line Speed (NELS)
inspection system and the New Turkey Inspection System (NTIS) to have
PQC programs and the requirements concerning the design, content, and
Agency approval of those programs. The proposal would also remove from
the thermal processing regulations the requirements for FSIS prior
approval of systems and devices not specified in the regulations and
all requirements concerning PQC programs. The proposal would expand the
alternatives available to establishments under the thermal processing
regulations for ensuring the safety of their products. This proposal is
intended to provide inspected establishments with flexibility, to make
the regulations more consistent with the Pathogen Reduction (PR)/Hazard
Analysis and Critical Control Points (HACCP) regulations, and to
encourage establishments to adopt new technologies and methods that
will improve food safety and other consumer protections.
DATES: Comments must be received on or before July 19, 1999.
ADDRESSES: Submit one original and two copies of written comments to
FSIS Docket Clerk, DOCKET #97-001P, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 112 Cotton Annex Building, 300
12th Street, SW., Washington, DC 20250-3700. All comments submitted in
response to this proposed rule will be available for public inspection
in the Docket Clerk's Office between 8:30 a.m. and 4 p.m., Monday
through Friday. Those who wish to make oral comments can schedule an
appointment with the person whose name appears in FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy
Administrator, Office of Policy, Program Development, and Evaluation,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Background
FSIS carries out programs designed to ensure that meat, poultry,
and egg products are wholesome, not adulterated, and properly marked,
labeled, and packaged. FSIS is implementing the ``Pathogen Reduction;
Hazard Analysis and Critical Control Point (HACCP) Systems'' final rule
published July 25, 1996 (61 FR 38806), to reduce the risk of foodborne
illness associated with the consumption of meat and poultry products to
the maximum extent possible. The Pathogen Reduction (PR)/HACCP final
rule requires establishments to take appropriate and feasible measures
to prevent or reduce the likelihood of physical, chemical, and
microbiological hazards in the production of meat and poultry products.
FSIS is reviewing its other regulations to determine how they can
be made more consistent with the PR/HACCP regulations and the
regulatory approach they embody. This approach favors performance-based
standards over prescriptive, command-and-control regulations. Command-
and-control requirements specify, often in great detail, how a plant is
to achieve particular food safety or other regulatory objectives, while
performance standards state the objectives or levels of performance to
be achieved and give a plant the ability to describe how it will
achieve them. Included in the Agency's review are regulations on
sanitation, meat and poultry products with visible defects affecting
safety or quality, and economic adulteration of meat and poultry
products.
FSIS announced its regulatory review in a December 29, 1995,
advance notice of proposed rulemaking (ANPR) ``FSIS Agenda for Change''
(60 FR 67469). The Agency said that, by eliminating unnecessary
regulations and replacing command-and-control prescriptions with
performance standards, inspected establishments would have greater
flexibility to adopt innovations that can yield food-safety benefits.
Among the regulations FSIS has identified as candidates for
modification or elimination are those that delimit processing and
treatment methods intended to eliminate specific food safety hazards
and requirements concerning quality control programs.
FSIS has already reduced its role of approving and specifying in
detail the design and operation of establishment-operated partial
quality control (PQC) programs. In 1997, the Agency published a final
rule that, among other things, removes the requirement for FSIS prior
approval of most PQC programs (62 FR 45016, August 25, 1997).
Recognizing that the establishment bears primary responsibility for the
control of its own manufacturing processes, FSIS now thinks it
appropriate to take the further step of eliminating PQC requirements
other than for irradiation of poultry (9 CFR 381.149(b)), so that
establishments will have the flexibility they need to be innovative,
and consistent with HACCP and the Agency's regulatory policy. (FSIS
proposed to remove requirements for quality control programs for
poultry-product irradiation in its February 24, 1999, proposal on the
irradiation of meat and meat products (64 FR 9809).)
Quality Control
Quality control, in general, is a planned, documented system of
activities intended to ensure the
[[Page 26893]]
stability of processes and uniformity of products. Quality control
programs and systems are based on the assumption that there is normal
variation in any process, and that the process is under control if that
variation is not exceeded.
In the food industry, quality control systems are used in
processing operations to make sure that products from TV dinners to
hotdogs will be exactly the same--will have the same content, flavor,
color, texture, etc.--no matter how many thousands are made in a
production run. Quality control programs can be used to maintain normal
process variation within the limits prescribed in a standard, such as
the 50-percent-fat limitation in a breakfast sausage. If the expected
variation is exceeded, corrective action is taken to restore process
stability.
Under FSIS regulations, a company may choose to place all of the
processes and products in a plant under a comprehensive, or total,
quality control system, or the company may choose to place only
individual products or processes under quality control. A quality
control program for only one process or product in a plant is known as
a partial quality control (PQC) program.
Some PQC programs control product potential health and safety
problems; others focus on economic or quality factors. PQC programs
controlling for safety factors include those for thermally processed
products, which are intended primarily to prevent toxin formation in
the processed product. The programs for cooked beef products are
intended to ensure that the processing of the products meets the
regulatory requirements for handling, processing (time, temperature,
and relative humidity), and storage to prevent pathogen formation in
the products. PQC programs that control for product safety have been
largely superseded by required HACCP plans.
PQC programs that control for economic or non-food-safety factors
include those used to control the fat and water content of hotdogs, the
number of meatballs in, or pepperoni slices on, a product, and the
moisture or protein-fat-free (PFF) content of a product labeled ``ham,
water added.'' The quality control program for mechanically separated
(species) (MS(S)) is intended to control bone particle size, calcium
content, fat and protein content, and protein efficiency ratio (9 CFR
319.5). The programs for pressed ham and spiced ham products are
intended to ensure that the products meet the PFF regulatory
requirements of Sec. 319.104.
PQC programs to control products for economic factors are intended
to prevent the marketing of products that are misbranded or that lack
the quality or value that consumers expect. A plant operating under a
PQC program for net weight keeps records of its checks and corrective
actions to avoid lot inspection. Under PQC programs for fat and water
in frankfurters, plants keep ingredient records by lot and results of
laboratory tests for verification by FSIS inspectors. A plant operating
a PQC program for boneless meat inspection does its own on-line
inspection and keeps records. The FSIS inspector randomly selects
samples of product that the plant has already inspected to ensure that
the records are accurate.
Establishments are required by current regulations to have PQC
programs for certain products or processes, such as the one for MS(S),
just mentioned. A PQC program for on-line carcass quality control is
required for an establishment operating under either the NELS or the
NTIS poultry inspection system (9 CFR 381.76(c)).
PQC Programs in Slaughtering Plants
The Agency conducts verification checks on the plant-operated PQC
programs required for certain inspection systems. Establishments being
considered for implementation of the NELS and NTIS inspection systems
(currently, about 10 per year) must meet requirements both for
facilities and for PQC programs.
Interested establishments are required to obtain FSIS approval of
their PQC programs before the programs can be implemented on a trial
basis. Unacceptable PQC programs are returned to the establishment for
correction.
Once approved, PQC programs are subject to on-site review by the
Agency for six months after implementation. The establishment then
submits an updated PQC program to the Agency for final review. If, at
that stage, the program is found to be acceptable, full approval is
granted, although the establishment remains subject to Agency
verification checks. If the program is unacceptable, the trial period
may be extended or approval of the program may be withdrawn.
The Agency provides guidelines to help interested establishments
prepare for implementation of the NELS and NTIS inspection systems.
Instructions for developing PQC programs are included in those
guidelines. The Agency also offers instruction on slaughter quality
control programs to Government and industry personnel at the FSIS
Training Center.
Proposed Changes
FSIS is proposing to eliminate the requirement in 9 CFR 317.21(b)
that establishments have, as an alternative to State or local
certification of scales, PQC programs or total quality control system
provisions for checking the accuracy of scales. The Agency is proposing
simply to require that there be a certification of accuracy from State
or local authorities or from a State-registered or -licensed scale
repair firm or person. Establishments could continue to maintain scale-
checking provisions in their QC programs and systems.
The Agency is proposing to remove from the meat and poultry
inspection regulations the design requirements for partial quality
control programs (9 CFR 318.4(d), 381.145(d)). The provisions outline
what is necessary when an establishment is required to have a PQC
program. Because the Agency is proposing to revoke the regulatory
requirements pertaining to PQC programs, there is no need to describe
what is necessary when PQC is required.
FSIS would also remove quality control requirements (9 CFR 318.7)
governing the use of nitrites in bacon curing and the use of certain
organic acids singly or in combination to delay the discoloration of
fresh meat cuts. Such requirements are incompatible with the Agency's
regulatory objectives because they specify a manner of compliance
rather than simply a performance standard.
Both the nitrite and the organic acid regulations clearly state the
maximum limits of use of the substances they concern. The consumer is
also informed by product labeling of the presence of the substances in
the products. The regulations provide clear limits and adequate
consumer protections without the quality control requirements. The
Agency is also proposing to improve the accuracy of the regulation by
using the term ``production of botulinum toxin'' rather than ``growth
of botulinum toxin'' (see 9 CFR 318.7(b)(3)(ii)). FSIS is aware that
these food-safety regulations also may be regarded as inconsistent with
the PR/HACCP regulations, but the Agency would prefer to address this
inconsistency in a future rulemaking.
The Agency proposes to make the meat and poultry canning
regulations (9 CFR 318.305 and 381.305) more consistent with the
Agency's new, non-command-and-control regulatory approach by
eliminating a number of prior-approval requirements. First, the
requirement that the Agency prior-approve temperature-indicating
devices other than mercury-in-glass
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thermometers (at Secs. 318.305(a)(1)(ii) and 381.305(a)(1)(ii)) would
be replaced. Temperature-indicating devices, such as resistance
temperature detectors, could be used and, as is the case currently,
they would have to meet known standards of accuracy for such devices,
but the frequency of testing for accuracy would not be prescribed.
The Agency is also proposing to remove the requirement for case-by-
case evaluation and approval by FSIS of thermal processing systems not
specified in the regulations. As amended, 9 CFR 318.305(f) and
381.305(f) would require that such systems be adequate to produce
shelf-stable products consistently and uniformly. These requirements
reflect the basic purposes of the canning regulations.
FSIS is also proposing to remove from the thermal processing
regulations (9 CFR 318.307(b) and 381.307(b)) provisions concerning PQC
programs and requirements for FSIS prior approval of thermal processing
systems not specified in the regulations, including monitoring and
recording devices not specified in the regulations. The Agency
tentatively concludes that these regulations will ensure the adequacy
of these systems without the requirement that the Agency is proposing
to delete, which is inconsistent with the PR/HACCP regulations.
The Agency is also proposing to remove from the thermal processing
regulations the requirements (in Secs. 318.308 and 309 and
Secs. 381.308 and 309) concerning partial quality control programs to
control process deviations and establishment finished product
inspection procedures. The Agency tentatively finds that these
requirements are unnecessary. The detailed prescriptions in these
sections, which are based on HACCP principles, would remain as
acceptable protections against potential microbial contamination.
Under this proposal, a thermal processing establishment would have
four alternatives available to control process deviations identified
in-process. The establishment could:
(1) Provide for how it will handle the deviations under a HACCP
plan; or, until subject to 9 CFR part 417, (2) follow the existing
regulations (Secs. 318.308(d) and 381.308(d)); (3) handle the
deviations under an approved total quality control system until the PR/
HACCP rule becomes applicable to it; or (4) use alternative documented
procedures for handling process deviations. The alternative documented
procedures could be provisions of a HACCP plan, such as corrective
actions to be taken, recordkeeping, or monitoring procedures, that
would be followed when process deviations occurred. They could also
include partial quality control programs, developed by or for the
establishment, but not subject to FSIS approval. Such food-safety-
related PQC programs would, however, be superseded by or integrated
with provisions of the establishment's HACCP plan when that plan is
implemented.
Similarly, under this proposal, a thermal processing establishment
would have four alternatives for handling finished product inspections.
The finished product inspections could be handled under: (1) The
existing regulations (Secs. 318.309(d) and 381.309(d)); (2) a HACCP
plan; (3) the provisions of an approved total quality control system,
until the PR/HACCP final rule is applicable to the establishment; or
(4) alternative documented procedures for handling finished product
inspections. The alternative documented procedures could be PQC
programs or the HACCP plan provisions.
In any case, any alternative procedures for handling process
deviations or finished product inspections would have to ensure that
only safe, stable product is shipped in commerce. This proposed
requirement dictates that not only would the procedures have to ensure
that the product is free of microorganisms of public health
significance, but also that it is not adulterated by other types of
microorganisms, such as ``flat-sour'' bacteria or other spoilage
organisms. This proposed requirement is consistent with the aims of
HACCP and with the statutory prohibitions against the distribution of
adulterated and misbranded meat and poultry products in commerce.
The proposed amendments would make the thermal processing
regulations more consistent with the PR/HACCP final rule by explicitly
providing a HACCP-plan alternative to the prescriptive procedures
(consistent with Sec. 417.2(b)(3)) and by including, as an option for
handling process deviations or final product inspections, alternative
documented procedures that ensure that only safe and stable products
are shipped in commerce. This option would provide the establishment
with the flexibility to use PQC programs or other procedures that meet
a regulatory public health standard.
It should be noted that, under the HACCP regulations, an
establishment's HACCP plan does not have to address potential microbial
hazards in thermally processed/commercially sterile product if the
establishment is following the current regulatory requirements for such
product. However, the HACCP plan must address physical and chemical
hazards to which the product may be subject.
Besides proposing to remove the requirements pertaining to PQC
programs that control food-safety factors, which are inconsistent with
PR/HACCP, FSIS is proposing to remove the requirements affecting
economic or quality-related PQC programs. FSIS considers these
requirements to be too prescriptive. They tend to perpetuate the
command-and-control approach to food inspection and regulation. They
are not in keeping with the Agency's new regulatory approach, which is
oriented more toward monitoring industry compliance with performance-
related objectives.
First, the Agency is proposing to remove the QC system requirements
from the regulations and requirements governing the identity and
composition of MS(S) product and label approval of the product (9 CFR
319.5). The MS(S) regulations specify the maximum calcium content, the
minimum protein content, the protein efficiency ratio, the maximum fat
content, and the maximum bone particle size for the product. The
regulations also specify the elements that the QC system must contain,
including a written description of the methods used by the
establishment to maintain uniformity of raw materials used in
manufacturing product and to control handling and processing of the raw
materials and finished product. The regulations also specify the sample
size and sampling frequency for food-chemistry analysis of product to
determine compliance with the standards. FSIS regards these provisions
as overly prescriptive and believes that, to achieve the purposes of
the MS(S) regulations, it is sufficient to set the product standards
for fat, protein, calcium content, and bone particle size.
The Agency is also proposing to update the provision for finished
product samples to be analyzed according to methods of the Association
of Official Analytical Chemists (AOAC) or methods listed in the FSIS
``Chemistry Laboratory Guidebook'' to reflect use of the most recent
edition of the AOAC compendium. In addition, FSIS is proposing to give
establishments the latitude to use validated scientific methods
equivalent to, but not listed in, the AOAC and FSIS references. Under
this proposed action, the establishments will have flexibility to
choose the most appropriate means of ensuring that
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MS(S) meets the compositional and labeling identity requirements of the
regulations, but they will also have the burden of demonstrating
equivalence.
The Agency is aware, however, that some may disagree with the
evaluation of the MS(S) QC and analytical requirements as overly
prescriptive; their comments on this matter are invited. Others may
regard the incorporation by reference of the AOAC methods as
unnecessary and such standards as those for fat content and protein
efficiency ratio as duplicative of other regulatory requirements. Their
comments are invited as well.
Second, consistent with the other changes proposed in this
document, FSIS is proposing to eliminate the quality control program
requirements from the protein-fat-free (PFF) percentage regulations
(Secs. 319.104 and 319.105) for various ``finely divided'' cured ham
products, such as patties, chopped or pressed ham, and spiced ham.
Establishments would still be required to abide by the PFF percentage
limits for these products.
Finally, FSIS is proposing to remove the requirement that poultry
slaughtering establishments operating under the NELS and NTIS
inspection systems have PQC programs for carcass defects. If this
proposed change is adopted, the establishments will have the
flexibility to adopt quality control programs or other measures for
ensuring the quality of their products. Removing the prior-approval
aspect of these requirements will contribute to clarifying the
respective roles of the inspection service and the regulated industry--
a necessary task in making the requirements consistent with HACCP.
FSIS inspectors would continue to check poultry in NELS and NTIS
plants for visible contamination and carcass trimming defects.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been determined to be significant, though
not economically significant, and was reviewed by the Office of
Management and Budget under Executive Order 12866.
FSIS is proposing to eliminate the regulatory requirements
pertaining to establishment-operated PQC programs. This action would
remove regulatory obstacles to innovation and command-and-control
requirements inconsistent with the Agency's new regulatory approach and
the objectives of the PR/HACCP regulations. In its August 25, 1997,
final rule (62 FR 45016), the requirements for FSIS prior approval of
most PQC programs were eliminated. This action was taken to facilitate
the transition to HACCP in official establishments producing the
greatest portion of meat and poultry products consumed in the United
States. FSIS is proposing to take the additional step of eliminating
most requirements for establishments to have PQC programs for specific
products or processes, as well as design requirements affecting most
PQC programs. The only PQC program requirements this proposal would
leave in place would be the requirement for QC programs for irradiated
chicken. However, as mentioned previously, this requirement is being
addressed in another rulemaking proceeding (64 FR 9809).
The alternatives to this proposed rulemaking that FSIS considered
were, in addition to the alternative of no rulemaking, those of
mandating additional in-plant controls and of mandating general
requirements and standards for PQC programs.
The alternative of no rulemaking would impose no additional
regulatory burdens on establishments, which would continue to have the
assurance that their PQC programs meet basic design criteria. However,
the Agency rejected this alternative because not changing the
regulations would leave in place a prescriptive regulatory regime for
process controls and PQC programs that conflict in a material way with
the objectives of the PR/HACCP final rule. Under HACCP, establishments
assume responsibility for building science-based, preventive process
controls into the food production system to reduce or eliminate food
safety hazards. This includes taking responsibility for ensuring that
processes conform with sound food safety performance standards.
Establishments need to be able to implement better and more innovative
food-safety and other consumer-protection strategies. This includes the
flexibility to design a PQC program and determine its content and
implementation date.
The alternative of mandating additional in-plant controls, whether
in addition to or in lieu of PQC requirements, would add regulatory
assurances that processes are under control and that products are safe,
wholesome, and not misbranded. However, this alternative would add
prescriptive, command-and-control requirements and restrict the scope
for establishment food-safety initiatives, contradicting the Agency's
new regulatory approach. The additional requirements also would
probably not result in food-safety improvement.
The alternative of mandating new general requirements or standards
for PQC programs would differ little in its effects from the current
requirements for PQC programs to have certain features and for process
control under the programs to be based on generally accepted
statistical principles (9 CFR 318.4(d); 381.145(d)). Even if the
current requirements were condensed, they would still be inconsistent
with the PR/HACCP regulations and with the Agency's new regulatory
approach, establishments would continue to incur a substantial
recordkeeping burden, and the Agency would have nearly the same burden
as it now does of verifying establishment compliance with the
requirements.
FSIS chose the option of eliminating regulatory requirements for
all PQC programs except QC programs for the irradiation of poultry
products. This option provides establishments with the most flexibility
in implementing process control programs in a HACCP environment. FSIS's
proposed rule on irradiation of meat and meat products (64 FR 9089,
February 24, 1999) would eliminate the requirement for QC programs in
facilities where poultry products are irradiated.
Implementation of this proposed rule would enable FSIS to redirect
resources from PQC program verification to other activities for
ensuring that products are not adulterated or misbranded. FSIS has
considered a number of alternatives to PQC program verification, such
as finished product sampling for microbiological or food chemistry
analysis and market sampling. Market sampling or national surveys can
be used in lieu of inspecting lots or evaluating PQC programs for fat
and water content of frankfurters. An alternative to FSIS evaluation of
PQC programs for basting solutions in poultry products is finished
product sampling for chemical analysis.
In-plant sampling of finished products for chemical analysis is a
tool that FSIS has used--and will continue to use--to determine whether
products are in compliance with regulatory requirements and to verify
the effectiveness of in-plant controls. To be most effective, such
sampling and analysis would be carried out in conjunction with Agency
HACCP-verification and other verification activities.
FSIS also regards market sampling as a potentially useful tool for
enforcing the statutes prohibiting the distribution in commerce of
adulterated and misbranded meat and poultry products and for checking
the effectiveness of establishment process controls.
[[Page 26896]]
Marketplace sampling and testing can also help in addressing food
safety hazards arising in post-processing distribution of meat and
poultry products.
This proposal would affect, overall, as many as 72 poultry
slaughtering establishments and about 3,550 establishments that process
meat and poultry products beyond slaughtering, dressing, and cut-up.
The most far-reaching effect of the rule would be to increase the
flexibility establishments have in controlling their processes. This
benefit would arise from eliminating the required PQC program elements
in Secs. 318.4(d) and 381.145(d).
With or without this proposal, establishment HACCP plans will
supersede or incorporate the few PQC programs that control food-safety
factors. Under the proposal, most establishments that have PQC programs
that control for non-food safety factors would continue to use the
programs. In all likelihood, in developing new PQC programs, they would
continue to include the information now required by FSIS. They would
also be free to adopt other methods of process control and different
techniques of observation, measurement, documentation, recordkeeping,
and evaluation than are prescribed in the current regulations. They
could change their PQC-controlled operations to integrate their food
quality process control more effectively with their HACCP system
operations to improve overall efficiency. For example, raw material
control, now a required element in PQC programs, could be handled under
an establishment?s HACCP plan, as could process controls for food
safety. Similarly, the records requirements for PQC programs could be
superseded by more efficient and appropriate establishment-developed
systems. Establishments would thus be able to achieve unquantifiable
gains in efficiency that would yield food-safety and other consumer-
protection benefits.
FSIS-inspected establishments develop about 1,900 PQC programs a
year according to regulatory design specifications. Assuming that a PQC
program is developed by a QC manager earning about $26 an hour, and
that it takes about 20 hours, on average, to develop a PQC program, the
cost to an establishment of developing such a program is about $520.
FSIS estimates that the cost to the regulated industry of developing
such programs is about $1,000,000 per year.
This cost of developing PQC programs according to FSIS
requirements, plus $13 million in annual operating costs for about
1,852 mandatory (required by regulation) PQC programs ($26/hr. X 260
hrs./yr./program X 1,852 programs), add up to about $14 million in
costs to the regulated industry.
For most establishments, the proposal would not yield immediate,
direct savings from removal of burdens associated with developing PQC
programs because most PQC programs are voluntarily adopted by
establishments. Establishments likely would continue the use of QC
methods in their operations, so the removal of the regulatory
requirement for establishments to follow the regulatory design
specifications would not immediately yield a savings to establishments.
Further, a substantial proportion of the costs of complying with this
regulation was removed with the publication of the final rule
eliminating prior approvals for facilities, equipment, and PQC programs
(62 FR 45016; August 25, 1997).
However, FSIS currently requires that if establishments adopt PQC
programs, the programs must meet certain design specifications and must
contain certain specified information. Some establishments that are
required to have PQC programs for certain products and processes would
benefit from the removal of burdens associated with developing PQC
programs. These establishments, including those involved in producing
MS(S), meat cuts treated with organic acids, and other processing,
could benefit from shifting some portion of their PQC program
development and operation costs into HACCP-related or other activities.
Also, under the proposed regulatory amendments, establishments
would have greater freedom to innovate. An indeterminate proportion of
the annual burden of developing PQC programs according to FSIS
specifications could eventually be channeled into more efficient and
effective use of industry resources, especially where PQC programs have
been operated.
Thus, although there would not be a direct savings from the removal
of the regulatory requirements governing PQC programs, the industry
potentially would be able to make more efficient and effective use of
the $1 million or so in annual costs of developing the programs.
Finally, the proposed rule would permit FSIS to reallocate field
inspection and headquarters resources now used in oversight of
establishment-operated PQC programs to higher priority food safety-
related activities.
Regulatory Flexibility Act
The Administrator of FSIS has determined that this proposed rule
will not have a significant effect on a substantial number of small
entities. The proposal would affect about 72 poultry slaughtering
establishments, most of which are large business enterprises. It also
would affect as many as 3,550 official meat and poultry processing
establishments, of which a substantial majority, 3,330, are considered
small entities under Small Business Administration criteria (500 or
fewer employees per establishment). However, the proposal would not
have a significant effect on these establishments. It would impose no
new regulatory requirements necessitating investments or other resource
commitments by establishments but would, by removing a number of
existing regulatory requirements, permit more efficient resource
utilization, especially to support establishment HACCP systems.
The proposal would remove most remaining requirements for
establishments to have PQC programs for certain products or processes
and the general requirement concerning the design of such programs. The
proposal would give inspected establishments greater flexibility to
innovate and to introduce new processes or products that meet HACCP or
other consumer protection objectives. As a result, the proposal would
theoretically provide several thousand dollars of regulatory relief
annually per establishment.
The proposal would enable establishments to avoid the costs
associated with developing and implementing PQC programs that address
regulatory requirements for the use of certain substances in
preparation of meat and poultry products, such as the use of organic
acids to delay discoloration of fresh meat cuts. Thermal processing
establishments (of which there are about 130) would avoid the costs
associated with developing PQC programs according to Agency
specifications and the costs associated with obtaining Agency prior
approvals.
As many as 3,330 small establishments would no longer be required
to operate PQC programs for certain processes (such as PQC programs for
processing cooked beef) and products (such as mechanically separated,
or ``deboned,'' product). Small and large establishments would
theoretically save about $520 per PQC program in development costs for
320 mandatory PQC programs, or $161,720 total. Out of this total, small
establishments would save about $151,320. Small establishments could
thus be expected to save about $4,000 each in annual recurring costs
associated with developing mandatory PQC programs.
[[Page 26897]]
Operating costs of PQC programs vary widely. A simple PQC program
to verify the accuracy of scales, for example, may require that tests
be performed only several times a year, at little cost in operator
time. A PQC program for a complex process, on the other hand, may
require daily tests and data collection and recordkeeping tasks lasting
up to 4 hours. For the purposes of this document, PQC programs are each
assumed to require up to 1 hour's worth of daily attention by the
establishment QC specialist. The removal of the PQC requirements would,
at least theoretically, relieve small establishments of these burdens.
Assuming, for example, that small establishments incur annual costs
of about $12,000,000 in operating mandatory PQC programs (solely in
operating the QC evaluation process of such programs, and not including
laboratory analysis, and other special facilities that may be required
to determine whether products are in compliance with the regulations),
each establishment could theoretically save about $4,000 in PQC program
operations.
In addition, small establishments would benefit through
unquantifiable savings accruing from removal of regulatory design
requirements for both mandatory and voluntary PQC programs. They would
have additional flexibility, beyond the removal of prior approval
requirements effected by FSIS Docket No. 95-032F, to develop and
implement HACCP-consistent or other process control systems.
Thus, about $8,000 in recurring savings could theoretically accrue
to each small meat and poultry establishment. However, because many, if
not most, affected establishments would be likely to continue to
operate PQC programs that help in producing products with consistent
and uniform characteristics, establishments may not choose to reap the
theoretical savings that could result from eliminating their PQC
programs. The effect of the proposed rule on the substantial number of
affected small establishments would thus not likely be substantial.
Paperwork Requirements
Title: Processing Procedures and Quality Control Systems.
Type of Collection: Revision.
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act. This proposed rule would substantially reduce reporting
requirements for official establishments. The proposed rule would
remove the design requirements affecting most PQC programs that
establishments have and most requirements for establishments to have
PQC programs for certain products or processes. Currently, there are
624,465 burden hours associated with the PQC program requirements. FSIS
will request OMB to eliminate all these burden hours from the
information collection request 0083-0089.
List of Subjects
9 CFR Part 317
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 318
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 319
Food labeling, Meat inspection.
9 CFR Part 381
Poultry and poultry products, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, FSIS is proposing to
amend 9 CFR Chapter III, the Federal meat and poultry inspection
regulations, as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 317.21 [Amended]
2. Paragraph (b) of Sec. 317.21 would be amended by removing the
comma and all words following the word ``person''.
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
3. The authority citation for part 318 would continue to read as
follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
Sec. 318.4 [Amended]
4. Paragraph (d) of Sec. 318.4 would be removed.
5. Section 318.7 would be amended to read as follows:
a. Paragraphs (b)(3)(i) and (b)(3)(ii) would be revised;
b. The table in paragraph (c)(4), under the Class of substance
``Miscellaneous,'' the entry for the Substance ``Ascorbic acid,
erythorbic acid, citric acid, sodium acetate, and sodium citrate,
singly or in combination'' would be revised.
The revisions would read as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(b) * * *
(3) * * *
(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550
ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be
used; or
(ii) A predetermined level between 40 and 80 ppm (potassium nitrite
at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium
erythorbate (isoascorbate); and additional sucrose or other similar
fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of
lactic acid producing bacteria such as Pediococcus acetolactii or other
bacteria demonstrated to be equally effective in preventing the
production of botulinum toxin at a level sufficient for the purpose of
preventing the production of botulinum toxin.
* * * * *
(c) * * *
(4) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class of substance Substance Purpose Product Amount
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
Miscellaneous..................... Ascorbic acid, erythorbic To delay Fresh beef cuts, Not to exceed, singly or in combination, 500
acid, citric acid, discoloration. fresh lamb cuts, ppm or 1.8 mg/sq inch of product surface of
sodium ascorbate and and fresh pork cuts. ascorbic acid (in accordance with 21 CFR
sodium citrate, singly 182.3013), erythorbic acid (in accordance
or in combination. with 21 CFR 182.3041), or sodium ascorbate
(in accordance with 21 CFR 182.3731); and/or
not to exceed, singly or in combination, 250
ppm or 0.9 mg/sq inch of product surface of
citric acid (in accordance with 21 CFR
182.6033), or sodium citrate (in accordance
with 21 CFR 182.6751).
[[Page 26898]]
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
6. Paragraphs (a)(1)(ii) and paragraph (f) of Sec. 318.305 would be
revised to read as follows:
Sec. 318.305 Equipment and procedures for heat processing systems.
(a) * * *
(1) * * *
(i) * * *
(ii) Other devices. Temperature-indicating devices used in lieu of
mercury-in-glass thermometers, such as resistance temperature
detectors, shall meet known, accurate standards for such devices when
tested for accuracy. The records of such testing shall be available to
FSIS program employees.
* * * * *
(f) Other systems. All other systems not specifically delineated in
this section and used for the thermal processing of canned product
shall be adequate to produce shelf-stable products consistently and
uniformly.
* * * * *
7. Paragraph (b) of Sec. 318.307 would be revised to read as
follows:
Sec. 318.307 Record review and maintenance.
* * * * *
(b) Automated process monitoring and recordkeeping. Automated
process monitoring and recordkeeping systems shall be designed and
operated in a manner which will ensure compliance with the applicable
requirements of Sec. 318.306.
* * * * *
8. In Sec. 318.308, paragraph (b) would be revised, paragraph (c)
would be removed and reserved, and paragraph (d) introductory text
would be revised to read as follows:
Sec. 318.308 Deviations in processing.
* * * * *
(b) Deviations in processing (or process deviations) shall be
handled:
(1) Under a HACCP plan for thermally processed/commercially sterile
product that addresses hazards associated with microbial contamination;
or
(i) Under the provisions of paragraph (d) of this section; or
(2) Until the establishment is subject to part 417 of this chapter,
(i) Under an FSIS-approved total quality control system; or
(ii) Under alternative documented procedures for handling process
deviations that will ensure that only product that is safe and stable
is shipped in commerce.
(c) [Reserved]
(d) Procedures for handling process deviations where the HACCP plan
for thermally processed/commercially sterile product does not address
food safety hazards associated with microbial contamination, where
there is no approved total quality control system, or where the
establishment has no alternative documented procedures for handling
process deviations.
* * * * *
9. In Sec. 318.309, paragraph (a) would be revised, paragraphs (b)
and (c) would be removed and reserved, and paragraph (d) introductory
text would be revised, to read as follows:
Sec. 318.309 Finished product inspection.
(a) Finished product inspections shall be handled:
(1) Under the provisions of paragraph (d) of this section;
(2) Under a HACCP plan for thermally processed/commercially sterile
products that addresses hazards associated with microbiological
contamination;
(3) Under an FSIS-approved total quality control system; or
(4) Under alternative documented procedures that will ensure that
only safe and stable product is shipped in commerce.
(b) [Reserved]
(c) [Reserved]
(d) Procedures for handling finished product inspections where the
HACCP plan for thermally processed/commercially sterile product does
not address food safety hazards associated with microbial
contamination, where there is no approved total quality control system,
or where the establishment has no alternative documented procedures for
handling finished product inspections.
* * * * *
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
10. The authority citation for part 319 continues to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
11. Paragraph (e)(2) of Sec. 319.5 would be revised to read as
follows:
Sec. 319.5 Mechanically Separated (Species).
* * * * *
(e) * * *
(2) Analytical methods used by establishments in verifying the fat,
protein, and calcium content of product consisting of or containing
Mechanically Separated (Species) shall be among those listed in
``Official Methods of Analysis of the Association of Official
Analytical Chemists (AOAC),'' 16th edition, 1995, Secs. 960.39, 976.21,
928.08 (Chapter 39), and 940.33 (Chapter 45), which is incorporated by
reference, or, if no AOAC method is available, in the ``Chemistry
Laboratory Guidebook,'' U.S. Department of Agriculture, Washington, DC,
March 1986 edition, sections 6.011-6.013, Revised June 1987 (pages 6-35
through 6-65), or by appropriate methods validated by scientific bodies
in collaborative trials. The ``Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 16th edition, 1995, is
incorporated by reference with the approval of the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.
Sec. 319.104 [Amended]
12. Section 319.104 would be amended in paragraph (a) by removing
the last sentence of footnote 3 to the chart.
Sec. 319.105 [Amended]
13. Section 319.105 would be amended in paragraph (a) by removing
the last sentence of footnote 2 to the chart.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
14. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
15. Section 381.76 would be amended to read as follows:
a. Paragraph (b)(1)(ii)(b) would be revised.
b. Paragraph (b)(1)(iii)(b) would be revised.
c. Paragraph (b)(4)(i)(a), introductory text, would be revised.
d. Paragraph (b)(4)(i)(b) would be revised.
e. Paragraph (b)(4)(ii) would be removed and reserved.
[[Page 26899]]
f. Paragraph (b)(4)(iii) would be removed and reserved.
g. Paragraph (b)(5)(i)(a) introductory text, would be revised.
h. Paragraph (b)(5)(i)(b) would be revised.
i. Paragraph (b)(5)(ii) would be removed and reserved.
j. Paragraph (b)(5)(iii) would be removed and reserved.
k. Paragraph (c) would be removed.
The revisions would read as follows:
Sec. 381.76 Post-mortem inspection, when required; extent;
traditional, Streamlined Inspection System (SIS), New Line Speed (NELS)
Inspection System and the New Turkey Inspection (NTI) System; rate of
inspection.
* * * * *
(b)(1) * * *
(ii) * * *
(b) The Administrator determines that the establishment has the
intent and capability to operate at line speeds greater than 70 birds
per minute, and meets all the facility requirements in Sec. 381.36(d).
(iii) * * *
(b) The Administrator determines that the establishment meets all
the facility requirements in Sec. 381.36(e).
* * * * *
(4) * * *
(i) * * *
(a) Post-mortem inspection. The establishment shall provide three
inspection stations on each eviscerating line in compliance with the
facility requirements Sec. 381.36(d)(1). The three inspectors shall
inspect the inside, viscera, and outside of all birds presented. Each
inspector shall be flanked by two establishment employees--the
presenter and the helper. The presenter shall ensure that the bird is
properly eviscerated and presented for inspection and the viscera
uniformly trailing or leading. The inspector shall determine which
birds shall be salvaged, reprocessed, condemned, retained for
disposition by the veterinarian, or allowed to proceed down the line as
a passed bird subject to reinspection. Poultry carcasses with certain
defects not requiring condemnation of the entire carcass shall be
passed by the inspector, but shall be subject to reinspection to ensure
the physical removal of the specified defects. The helper, under the
supervision of the inspector, shall mark such carcasses for trim when
the defects are not readily observable. Trimming or birds passed
subject to reinspection shall be performed by:
* * * * *
(b) A reinspection station shall be located at the end of each
line. This station shall comply with the facility requirements in
Sec. 381.36(d)(2). The inspector shall ensure that the establishment
has performed the indicated trimming of carcasses passed subject to
reinspection by visually monitoring, checking data, and/or gathering
samples at the station or at other critical points on the line.
(ii) [Reserved]
(iii) [Reserved]
(5) * * *
(i) * * *
(a) Post-mortem inspection. Each inspection station must comply
with the facility requirements in Sec. 381.36(e)(1). Each inspector
shall be flanked by and establishment employee assigned to be the
inspector's helper. The one inspector on an NTI-1 Inspection System
shall be presented every bird. Each inspector on an NTI-2 Inspection
System line shall be presented every other bird on the line. An
establishment employee shall present each bird to the inspector
properly eviscerated with the back side toward the inspector and the
viscera uniformly trailing or leading. Each inspector shall inspect the
inside, viscera, and outside of all birds presented. The inspector
shall determine which bird shall be salvaged, reprocessed, condemned,
retained for disposition by a veterinarian, or allowed to proceed down
the line as a passed bird subject to reinspection. Turkey carcasses
with certain defects not requiring condemnation of the entire carcass
shall be passed by the inspector, but shall be subject to reinspection
to ensure the physical removal of the specified defects. The helper,
under the supervision of the inspector, shall mark such carcasses for
trim when the defects of birds passed subject to reinspection shall be
performed by:
* * * * *
(b) Reinspection. A reinspection station shall be located at the
end of the lines. This station shall comply with the facility
requirements in Sec. 381.36(e)(2). The inspector shall ensure that
establishments have performed the indicated trimming of each carcass
passed subject to reinspection by visually monitoring, checking data,
and/or sampling product at the reinspection station and, if necessary,
at other points, critical to the wholesomeness of product, on the
eviscerating line.
(ii) [Reserved]
(iii) [Reserved]
Sec. 381.121d [Amended]
16. Paragraph (b) of Sec. 381.121d would be amended by removing the
comma and all words following the word ``person.''
Sec. 381.145 [Amended]
17. Paragraphs (d) and (e) of Sec. 381.145 would be removed.
18. Paragraphs (a)(1)(ii) and (f) of Sec. 381.305 would be revised
to read as follows:
Sec. 381.305 Equipment and procedures for heat processing systems.
(a) * * *
(1) * * *
(ii) Other devices. Temperature-indicating devices used in lieu of
mercury-in-glass thermometers, such as resistance temperature
detectors, shall meet known, accurate standards for such devices when
tested for accuracy. The records of such testing shall be available to
FSIS program employees.
* * * * *
(f) Other systems. All other systems not specifically delineated in
this section and used for the thermal processing of canned product
shall be adequate to produce shelf-stable products consistently and
uniformly.
* * * * *
19. Paragraph (b) of Sec. 381.307 would be revised to read as
follows:
Sec. 381.307 Record review and maintenance.
* * * * *
(b) Automated process monitoring and recordkeeping. Automated
process monitoring and recordkeeping systems shall be designed and
operated in a manner which will ensure compliance with the applicable
requirements of Sec. 381.306.
* * * * *
20. In Sec. 381.308, paragraphs (b) would be revised, paragraph (c)
would be removed and reserved, and paragraph (d) introductory text
would be revised to read as follows:
Sec. 381.308 Deviations in processing.
* * * * *
(b) Deviations in processing (or process deviations) shall be
handled:
(1) Under a HACCP plan for thermally processed/commercially sterile
product that addresses hazards associated with microbial contamination;
or
(i) Under the provisions of paragraph (d) of this section; or,
(ii) Under a HACCP plan for thermally processed/commercially
sterile product that addresses hazards associated with microbial
contamination; or
(2) Until the establishment is subject to part 417 of this chapter,
(i) Under an FSIS-approved total quality control system; or
(ii) Under alternative documented procedures for handling process
deviations that will ensure that only product that is safe and stable
is shipped in commerce.
[[Page 26900]]
(c) [Reserved]
(d) Procedures for handling process deviations where the HACCP plan
for thermally processed/commercially sterile product does not address
food safety hazards associated with microbial contamination, where
there is no approved total quality control system, or where the
establishment has no alternative documented system or procedures for
handling process deviations.
* * * * *
21. In Sec. 381.309, paragraph (a) would be revised, paragraphs (b)
and (c) would be removed and reserved, and paragraph (d) introductory
text would be revised, to read as follows:
Sec. 381.309 Finished product inspection.
(a) Finished product inspections shall be handled:
(1) Under the provisions of paragraph (d) of this section;
(2) Under a HACCP plan for thermally processed/commercially sterile
products that addresses hazards associated with microbiological
contamination;
(3) Under an FSIS-approved total quality control system; or
(4) Under alternative documented procedures that will ensure that
only product that is safe and stable is shipped in commerce.
(b) [Reserved]
(c) [Reserved]
(d) Procedures for handling finished product inspections where the
HACCP plan for thermally processed/commercially sterile product does
not address food safety hazards associated with microbial
contamination, where there is no approved total quality control system,
or where the establishment has no alternative procedures for handling
finished product inspections.
* * * * *
Done at Washington, DC, on May 11, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-12352 Filed 5-17-99; 8:45 am]
BILLING CODE 3410-DM-P