[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  

[[Page 26892]]


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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