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FSIS Eliminates Requirements for Partial Quality Control Programs

[Federal Register: May 30, 2000 (Volume 65, Number 104)]
[Rules and Regulations]
[Page 34381-34391]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my00-1]

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Rules and Regulations
[[Page 34381]]


DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317, 318, 319, 381, and 424
[Docket No. 97-001F]
RIN 0583-AC35

Elimination of Requirements for Partial Quality Control Programs
AGENCY: Food Safety and Inspection Service.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
meat and poultry products inspection regulations by removing the
remaining requirements pertaining to partial quality control (PQC)
programs. A PQC program controls a single product, operation, or part
of an operation in a meat or poultry establishment. FSIS is removing
the design requirements for PQC programs and the requirements for
establishments to have PQC programs for certain products or processes.
For example, poultry slaughtering establishments operating under the
New Line Speed (NELS) inspection system and the New Turkey Inspection
System (NTIS) will no longer be required to operate PQC programs in
conjunction with those systems. FSIS also is removing from the thermal
processing regulations all requirements concerning PQC programs, the
requirements for case-by-case FSIS approval of systems and devices not
specified in the regulations, and several other prior approval
requirements. The amended regulations will be more consistent with the
Pathogen Reduction (PR)/Hazard Analysis and Critical Control Points
(HACCP) regulations and inspected establishments will have greater
flexibility to adopt new technologies and methods that will improve
food safety and other consumer protections.

EFFECTIVE DATE: August 28, 2000. The material incorporated by reference
is approved by the Director of the Federal Register as of August 28,
2000.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Director,
Regulations Development and Analysis Division, Office of Policy,
Program Development, and Evaluation, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250-3700;
(202) 720-5627.

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.
Specifically, the PR/HACCP final rule: (1) Requires each official meat
and poultry establishment to develop and implement written sanitation
standard operating procedures (Sanitation SOP's); (2) requires regular
microbial testing (for generic Escherichia coli) by slaughter
establishments to verify the adequacy of the establishment's process
controls for the prevention and removal of fecal contamination and
associated bacteria; (3) establishes pathogen reduction performance
standards for Salmonella that slaughter establishments producing raw
ground products must meet; and (4) requires that all meat and poultry
establishments develop and implement a system of preventive controls
designed to improve the safety of their products, known as HACCP.
HACCP is a conceptually simple, science-based process control
system by which food processors identify and evaluate hazards to the
production of safe products, institute controls necessary to reduce or
eliminate those hazards, monitor the performance of these controls, and
maintain records of this monitoring.
FSIS is reviewing its regulations to determine how they can be
revised to conform with the PR/HACCP regulations and the regulatory
approach they embody. This approach favors performance-based standards
over prescriptive, command-and-control regulations. In its December 29,
1995, advance notice of proposed rulemaking (ANPR) ``FSIS Agenda for
Change: Regulatory Review'' (60 FR 67469), FSIS 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. Identified as candidates for modification or
elimination were those regulations that delimit processing and
treatment methods intended to address specific food safety hazards and
requirements that establish quality control programs.
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 (TQC) 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, or PQC, program. This final rule addresses
PQC programs.
Some PQC programs control 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 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

[[Page 34382]]

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.
FSIS regulations have required establishments 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 has been
required for an establishment operating under either the NELS or the
NTIS poultry inspection system (9 CFR 381.76(c)).
In 1997, the Agency published a final rule that, among other
things, removed the requirement for FSIS prior approval of most PQC
programs (62 FR 45016; August 25, 1997). FSIS now thinks it appropriate
to take the further step of eliminating the remaining PQC requirements
so that establishments will have the flexibility they need to be
innovative, consistent with HACCP and the Agency's regulatory policy.
On May 18, 1999, FSIS proposed to amend the meat and poultry
products inspection regulations by removing requirements pertaining to
PQC programs, except programs for poultry product irradiation plants
(64 FR 26892). The December 23, 1999, final rule ``Irradiation of Meat
Food Products'' removed requirements for quality control programs in
such irradiation plants (64 FR 72165).

Comments Received

FSIS received six letters in response to the May 18, 1999,
proposal. All were from the regulated industry and all supported the
proposal. Some commenters wanted clarification of matters addressed in
the preamble of the proposal, and one requested the removal of
additional regulatory restrictions. The substantive comments and the
Agency's responses are summarized below.
Comment: An organization representing the food processing industry
supported the proposed removal from the thermal processing regulations
of requirements for FSIS prior approval of systems and devices not
specified in the regulations and of all requirements concerning PQC
programs. This commenter also recommended the removal from these
regulations of additional command-and-control provisions. The commenter
asked that, in the regulations on the handling of containers after
closure (9 CFR 318.301(f)(2) and 381.301(f)(2)), approval by a
processing authority replace the need to obtain the FSIS
Administrator's permission for a time lapse between container closing
and initiation of thermal processing of greater than two hours.
Response: FSIS set the regulatory maximum 2-hour time period
between container closure and initiation of the thermal process in its
1984 canning regulation amendments. The Agency did so to prevent
adulteration from the holding of unprocessed products for an extended
period, and because it was aware of several documented incidents of
illness from staphylococcal enterotoxin in such products. The
commenter's suggested change would place the judgment whether to alter
the specified time interval between closure and the initiation of
thermal processing with the process authority rather than the FSIS
Administrator.
A processing authority is an individual or organization with expert
knowledge of thermal processing requirements for foods in hermetically
sealed containers, having access to facilities for making such
determinations, and designated by the establishment to perform certain
functions required by the regulations. FSIS already requires the
processing authority to perform the vital function of developing and
determining the process schedule and specifying the critical factors in
the process.
The change suggested by the commenter is consistent with the
Agency's stated aim of making the meat and poultry canning regulations
more consistent with the Agency's new, non-command-and-control
regulatory approach by eliminating some prior approval requirements.
With respect to the canning regulations, however, this rulemaking
addresses only PQC programs and prior approval requirements other than
the one addressed by the commenter. FSIS therefore considers the
commenter's request to be outside the scope of this rulemaking.
Comment: The same commenter requested the addition to the
regulations on pH measurement in canning plants (9 CFR 318.304(e) and
381.304(e)) of a provision allowing use of colorimetric or other
methods in addition to potentiometric methods, provided that the
methods are sufficiently accurate to ensure product safety and
stability. The commenter also asked for the removal of the requirement
for approval by the FSIS Administrator of methods other than the
potentiometric. In addition, the commenter requested the removal of the
requirement at 9 CFR 318.305(h)(2) and 381.305(h)(2) for approval by
the FSIS Administrator for the use in cooling canal water of chemicals
other than chlorine that have a bactericidal effect equivalent to that
of chlorine.
Response: As stated in the previous response, FSIS proposed to make
the thermal processing regulations more consistent with its new
regulatory approach by eliminating provisions concerning PQC programs
and certain prior approval requirements. FSIS did not propose changes
in its requirements for pH measuring devices or chemicals used in
cooling canal water. These suggested changes are outside the scope of
this rulemaking, and, accordingly, FSIS is not making them in this
final rule.
Regarding the regulation on chemicals in cooling canal water, FSIS
announced in early 1998 that it was ending its prior approval system
for all non-food compounds and proprietary substances (63 FR 7319;
February 13, 1998). These classes of substances include water treatment
compounds. The program was ended because the Agency considered it to be
redundant with those of other Federal agencies and because of the
program's inconsistency with the PR/HACCP regulations.
Since establishments are responsible for developing and
implementing HACCP plans incorporating the controls necessary and
appropriate to produce safe meat and poultry products, FSIS is not
responsible for determining whether the nonfood compounds and
proprietary substances they use are safe and effective. Therefore,
establishments need not obtain the approval of the Administrator to use
chemicals other than chlorine in cooling canal water.
Nevertheless, FSIS retains the discretionary authority to prevent
the use of such substances in official establishments if the Agency
finds, through its normal inspection activities,

[[Page 34383]]

that the substances directly or indirectly contaminate edible product.
FSIS expects establishments to use only compounds that are safe and
that have the intended technical effect when used appropriately in a
food preparation environment. The Agency expects establishments to keep
on file any information provided by chemical manufacturers (written
approvals from other agencies, letters of guaranty, etc.) as part of
their sanitation SOP, HACCP, or other records.
Comment: The same commenter requested the removal of two other
prior-approval requirements in the canning regulations: first, the
requirement (in 9 CFR 318.305(a)(2)(ii) and 381.305(a)(2)(ii))for FSIS
Administrator approval of recording devices other than temperature/time
recording devices; and second, the requirement at 9 CFR 318.305(d)(5)
and 381.305(d)(5) that the FSIS Administrator be notified of the use of
any batch retorts with steam/air circulation systems.
Response: FSIS proposed the elimination of the requirement for
prior-approval of thermometric measuring devices other than mercury-in-
glass thermometers (proposed Secs. 318.305(a)(1)(ii) and
381.305(a)(1)(ii)). The Agency also proposed the elimination of prior
approval requirements for automated process monitoring and
recordkeeping systems not specified in the canning processing
regulations (proposed Secs. 318.307(b) and 381.307(b)). The commenter's
suggestion to remove the requirement in Secs. 318.305(a)(2)(ii) and
381.305(a)(2)(ii) for prior approval of time/temperature recording
devices other than chart-type devices is consistent with the Agency's
proposals regarding temperature measurement and automatic process
monitoring devices. Accordingly, FSIS is making the requested change to
the regulations in this final rule.
Regarding the prior approval of batch retorts with steam-air
cooling, FSIS finds the commenter's request to be consistent with the
Agency's proposal to eliminate the requirement for prior approval of
thermal processing systems other than those delineated in Secs. 318.305
and 381.305 of the canning regulations (proposed Secs. 318.305(f) and
381.305(f)). FSIS is therefore adopting the requested change in this
final rule.
Comment: The same commenter--the organization representing the food
processing industry--questioned the intent of the Agency's statement in
the preamble of the proposal regarding alternative documented
procedures for handling process deviations or finished product
inspections. FSIS stated, at 64 FR 26894, that such procedures ``would
have to ensure that only safe, stable product is shipped in commerce.''
The procedures would have to ensure that the product is free of
microorganisms of public health significance and is not adulterated by
other types of bacteria, such as ``flat-sour'' bacteria or other
spoilage organisms.
The commenter thought that the Agency's statement could be
misinterpreted to mean that a product might be adulterated if spoilage
organisms were merely present in a product not likely to be subject to
conditions that would lead to the growth of the organisms and
deterioration of the product. Citing the regulatory definition of shelf
stability (at 9 CFR 318.300 and 381.300), the commenter pointed out
that the presence in low numbers of flat-sour bacteria or other
spoilage organisms that would not grow under intended conditions of
distribution and storage would not render the product adulterated.
However, the growth of spoilage organisms to high numbers that affected
product characteristics before or after processing would adulterate the
finished product. The product then would not be cleared by a processing
authority or released into commerce.
Response: The commenter has accurately explained the intended
meaning of the phrase ``adulterated by * * * spoilage organisms'' in
the preamble of the proposal (at 64 FR 26894). In stating the
conditions for use of procedures alternative to the existing
prescriptive requirements (9 CFR 318.308(d) and 381.308(d); 9 CFR
318.309(d) and 381.309(d)), FSIS assumed the current regulatory
definitions of ``shelf stability.''
Comment: The same commenter questioned whether the Agency's example
of an establishment's incorporation of a PQC program for raw materials
in the establishment's HACCP plan (at 64 FR 26896) might imply that
non-food safety regulatory concerns might become part of HACCP systems,
which only address food safety issues.
Response: FSIS agrees with the commenter that HACCP systems are
only intended to control food safety hazards. The Agency recognizes the
potential for misunderstanding that can arise when PQC programs and
HACCP systems are discussed because PQC programs may address either
safety or quality issues or both. The context of the statements to
which the commenter refers was the analysis of benefits of the rule.
One benefit to establishments is a possible efficiency gain through
integration of some facets of quality control with HACCP. FSIS meant to
suggest by its example that a food safety-related PQC program or other
food safety process control could be used in the context of an
establishment's HACCP plan. The HACCP plan would include a critical
control point for raw materials only if the hazard analysis identified
a food safety hazard associated with raw materials. Raw material
control is identified as a CCP in many HACCP plans and is not so
identified in others. A PQC program for raw materials or any other step
in processing a product would be relevant to HACCP and be subject to
being subsumed in or superseded by a HACCP plan only if it were food
safety-related.
Comment: The food-processing industry organization also read
proposed Sec. 318.308(b)(2) and Sec. 381.308(b)(2) as inadvertently
depriving very small establishments of the option of using the
alternative procedures for handling process deviations (Sec. 318.308(d)
and Sec. 381.308(d)).
Response: The proposal language did not exclude any canning
establishment without a HACCP plan that addresses microbial hazards
from using the procedures in paragraph (d) of Sec. 318.308 or
Sec. 381.308. Further, under the final rule, these procedures will
continue to be available to establishments whose HACCP plans do not
address microbial hazards.
Comment: Three of the commenters--the food-processing industry
organization, an organization representing the Nation's turkey
industry, and a producer of processed meat and poultry products--wanted
FSIS to continue to recognize the value of PQC programs, and
particularly of those programs that the Agency has previously approved.
The food-processing industry organization expressed concern that such
programs might automatically become invalid when the final rule goes
into effect. The organization wanted the Agency to address this matter
in implementing notices or directives to the FSIS field force lest
previously approved procedures have to be re-documented.
Response: FSIS has not changed its policy of encouraging
establishments to adopt statistically sound quality control systems.
FSIS recognizes, however, that product formulations, processing
operations, and technology may change over time, and that
establishments should have the ability to change the variables and
parameters of their control programs without seeking Agency
revalidation of those programs. The Agency is therefore removing the

[[Page 34384]]

prescriptive, command-and-control regulatory requirements that may
inhibit innovation--especially innovation that may yield food safety
benefits. The Agency's approval process for PQC programs was part of
that old command-and-control system.
Obviously, a PQC program that the Agency approved in the past may
still be regarded as useful if no significant changes have been made in
the process or product controlled. However, the proof of the program's
effectiveness must be found primarily in the data collected under the
program or other studies of the product or process controlled and not
in an old approval letter. This is particularly the case with respect
to food safety-related PQC programs. Where food safety is concerned,
FSIS will be relying primarily on its verification of HACCP systems to
determine whether official establishments are taking sound control
measures.
Regarding the enforcement of this final rule, FSIS will issue
appropriate instructions to its field force. Many of the changes
necessary to carry out this final rule have already been instituted
with the revision of the Agency's automated system for directing
inspection program activities.
Comment: An organization representing the meat and poultry canning
industry supported the proposal but thought the preamble should have
expanded on how and why the elimination of PQC programs would not
diminish consumer confidence. The commenter thought that FSIS should
have furnished a more comprehensive explanation of PR/HACCP for readers
unfamiliar with it, and of why and how PR/HACCP systems make PQC
programs redundant. The commenter also thought the explanation for the
elimination of specific PQC requirements was insufficient to allay
consumer skepticism or fears about eliminating such requirements. In
particular, a more substantial justification should have been given for
removing FSIS case-by-case approval of thermal processing systems not
specifically delineated in the regulations. In this context, the
commenter thought that FSIS should have discussed the fact that
scientific evaluation of all new processes by competent experts is a
long-established practice of the canned food industry.
Response: FSIS made an editorial decision to limit the explanation
of the PR/HACCP final rule and its underlying principles because they
had been fully discussed in previous Agency publications and at the
many public meetings and media events conducted since 1995. The PR/
HACCP final rule and the other documents referred to in the preamble of
the proposal were made available for public viewing in the FSIS Docket
Room at the address given in the proposal. Nevertheless, in response to
the commenter's suggestion, FSIS has added, near the beginning of this
preamble, a summary of the main features of the PR/HACCP final rule.
While FSIS may not have provided a discussion of PR/HACCP
sufficient to satisfy the commenter, the Agency did state in the
proposal that requirements for PQC programs that control for product
safety have been superseded by required HACCP plans (64 FR 26893, col.
1). The Agency also stated that requirements pertaining to PQC programs
that control food safety factors are inconsistent with PR/HACCP (64 FR
26894, col. 3). The Agency further stated or implied in a number of
places (64 FR 26892, col. 3; 26893, col. 3; 26894, col. 1, col. 3;
26895, col. 2, col. 3; and 26896, col. 2) that regulatory requirements
for PQC programs tend to restrict innovation and perpetuate the
command-and-control approach to food inspection and regulation. Such
regulatory requirements are not in keeping with the Agency's new
approach of defining industry compliance with performance-related
objectives.
On the matter of consumer protection, the Agency stated that the
proposed rule was intended to provide inspected establishments with
flexibility and to encourage them to adopt new technologies and methods
that will improve food safety and other consumer protections (64 FR
26892, 26895 col. 2). The Agency also stated, with respect to PQC
programs required to ensure compliance with regulatory limits on
certain restricted ingredients (64 FR 28693, col. 3) and with product
standards, that the limits and standards themselves, as well as product
labeling requirements, would continue to protect consumers (64 FR
26894, col. 3; 26895, col. 1).
FSIS stated that PQC programs were not necessary to ensure food
safety protection where HACCP plans were in operation (64 FR 26894,
col.2). It may be that FSIS could have said more about its regulatory
provisions for continued consumer protection, but in the Agency's
judgment, what it said was sufficient for the purposes of the
rulemaking.
On the elimination of case-by-case approval of new types of thermal
processing systems in 9 CFR 318.305(f) and 381.305(f), new systems must
still meet the applicable requirements governing equipment and heat
processing procedures and be capable of producing shelf-stable products
consistently and uniformly. FSIS stated in the preamble of the proposal
(at 64 FR 26894) that these requirements reflect the basic purposes of
the canning regulations.
The canning regulations continue to address such matters as:
container integrity before and after fill; container closure; thermal
processing schedules; critical factors; operations in the thermal
processing area; processing and production records; deviations in
processing; finished product standards; recalls; and the role of the
processing authority. FSIS has recognized that the thermal processing
regulations are HACCP-consistent with respect to the control of
microbial hazards and has supplemented them with a requirement for
HACCP plans that address physical and chemical hazards. The Agency also
realizes, however, that many of these regulations are excessively
prescriptive and in its December 29, 1995, ANPR, cited above, listed
them among candidates for revision or removal in conjunction with HACCP
implementation.
The commenter's statement about the canning industry's practice of
having all new processes evaluated scientifically by competent experts
is a point well taken. Both the FDA and the FSIS regulations governing
thermally processed, low-acid foods in hermetically sealed containers
require thermal process schedules to be established by qualified
persons--processing authorities--who have expert knowledge of thermal
processing requirements for such foods and access to the facilities to
make the necessary determinations (21 CFR 113.83; 9 CFR 318.302,
381.302). These requirements remain in effect for canned products.
Also, FSIS has thought well enough of the process-authority concept to
make use of it in the final rule ``Performance Standards for the
Production of Certain Meat and Poultry Products'' (64 FR 732; January
6, 1999). Under that final rule, affected products not produced under a
HACCP plan must be produced according to a process schedule approved in
writing by a process authority for safety and efficacy in meeting the
performance standards applicable to the product.
Regarding the interest commenters have shown in the few changes in
the canning regulations to be made in this final rule, FSIS notes that
in the December 29, 1995, ANPR cited above, FSIS listed the
requirements for canning and canned products as candidates for reform.
Possible actions to be taken were the conversion of these requirements
to performance standards

[[Page 34385]]

and clarifying the role of inspection program employees. A future
rulemaking to reform the canning regulations remains under
consideration.

Regulation Changes Adopted

FSIS is eliminating 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 will simply 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 can, of course, continue to maintain scale-checking
provisions in their QC programs and systems.
The Agency is removing from the meat and poultry inspection
regulations the design requirements for partial quality control
programs (9 CFR Sec. 318.4(d), Sec. 381.145(d)).
FSIS also is removing quality control requirements 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
(9 CFR 424.21-.22). 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. Also, the consumer is informed by
product labeling of the presence of the substances in products. The
regulations provide clear limits and adequate consumer protections
without the quality control requirements. In addition, the Agency is
improving the accuracy of the regulation by using the term ``production
of botulinum toxin'' rather than ``growth of botulinum toxin'' (see 9
CFR 424.22(b)(1)(ii)(B)).
FSIS is eliminating a number of prior-approval requirements from
the meat and poultry canning regulations. The Agency is replacing the
requirement that the Agency approve temperature-indicating devices
other than mercury-in-glass thermometers (at Secs. 318.305(a)(1)(ii)
and 381.305(a)(1)(ii)) before they could be used. The devices must meet
known standards of accuracy for such devices, but the Agency is not
prescribing the frequency of testing for accuracy.
The Agency is removing the requirement for FSIS prior-approval of
the use of time/temperature recording devices other than chart-type
devices. The alternative devices must meet known standards of accuracy
(9 CFR 318.305(a)(1)(ii) and (a)(2)(ii); 9 CFR 381.305(a)(1)(ii) and
(a)(2)(ii)).
In response to comments, the Agency is removing the requirement at
9 CFR 318.305(d)(5) and 381.305(d)(5) that the FSIS Administrator be
notified of the use of any batch retorts with steam/air circulation
systems. As explained previously in this document, FSIS regards this
action as consistent with the proposed rule.
As proposed, the Agency is removing the requirement for FSIS case-
by-case evaluation and prior approval of systems for thermally
processing canned product other than those systems specifically
delineated in the regulations. Such alternative systems must still be
adequate for producing shelf-stable product consistently and uniformly.
(9 CFR 318.305(f), 381.305(f).)
FSIS is removing from the thermal processing regulations (9 CFR
318.307(b) and 381.307(b)) requirements for FSIS approval of automated
process monitoring and recordkeeping systems.
The Agency also is removing 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 finds that these requirements are unnecessary. The remaining
provisions in these sections, which are based on HACCP principles,
remain as acceptable protections against potential microbial
contamination.
The proposal would have provided additional options for
establishments, such as handling the deviations under an approved total
quality control system or using alternative documented procedures until
the PR/HACCP rule became applicable to the establishment. The
alternative documented procedures could have included partial quality
control programs or other documented corrective action, monitoring, or
recordkeeping procedures developed by or for the establishment, but not
subject to FSIS approval. Such food safety-related PQC programs were to
be integrated in or superseded by the establishment's HACCP plan.
Because the effective date of the final rule is after January 25, 2000,
however, the PR/HACCP regulations will be applicable to all
establishments that are subject to the final rule. Thus, there is no
need to provide options for establishments that are not yet subject to
the PR/HACCP requirements. Deviations in processing will need to be
handled according to a HACCP plan that addresses hazards associated
with microbial contamination or by the alternative procedures for
handling deviations during processing or through record review
(Secs. 318.308(d) and 381.308(d)).
A thermal processing establishment will have available at least
three 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; or (3)
alternative documented procedures for handling finished product
inspections. The alternative documented procedures can be PQC programs
or the HACCP plan provisions.
In any case, any alternative procedures for handling process
deviations or finished product inspections will have to ensure that
only safe, stable product is shipped in commerce. The procedures will
have to ensure that the product is free of microorganisms of public
health significance, and that it does not contain other types of
microorganisms, such as ``flat-sour'' bacteria or other viable spoilage
organisms, that could cause adulteration under intended conditions of
distribution and storage of the product. This 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.
These amendments and revisions will make the thermal processing
regulations more consistent with the PR/HACCP final rule by explicitly
providing a HACCP-plan alternative (consistent with Secs. 417.2(b)(3))
to the prescriptive procedures in Secs. 318.309(d) and 381.309(d). The
amended and revised regulations also include, 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 will 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 removing the requirements pertaining to PQC programs that
control food safety factors, which are

[[Page 34386]]

inconsistent with PR/HACCP, FSIS is removing the requirements affecting
economic or quality-related PQC programs. FSIS considers both the food
safety-related and the economic PQC 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.
FSIS is removing 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 also is updating 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, establishments will have
the latitude to use validated scientific methods equivalent to, but not
listed in, the AOAC and FSIS references. They will have the flexibility
to choose the most appropriate means of ensuring that MS(S) meets the
compositional and labeling identity requirements of the regulations.
The Agency cautions, however that, if the establishment is to
adequately protect its interests, it should ensure that the method that
it uses will produce results comparable to the relevant AOAC or FSIS
method.
Second, FSIS is eliminating 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, however, must continue to comply with the PFF
percentage limits for these products.
Finally, FSIS is removing the requirement that poultry slaughtering
establishments operating under the NELS and NTIS inspection systems
have PQC programs for carcass defects. The establishments will now 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 contributes 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 will continue to check poultry in NELS and NTIS
plants for visible contamination and carcass trimming defects.

Executive Order 12866 and Regulatory Flexibility Act

This final 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 eliminating the regulatory requirements pertaining to
establishment-operated PQC programs. This action removes regulatory
obstacles to innovation and command-and-control requirements, which are
inconsistent with the Agency's new regulatory approach and the
objectives of the PR/HACCP regulations. In the Agency's August 25,
1997, final rule ``Elimination of Prior Approval Requirements for
Establishment Drawings and Specifications, Equipment, and Certain
Partial Quality Control Programs'' (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 now taking the
additional step of eliminating the remaining requirements for
establishments to have PQC programs for specific products or processes,
as well as design requirements affecting PQC programs.
The alternatives to this rulemaking that FSIS considered were, in
addition to the alternative of no rulemaking, those of mandating
additional in-plant controls and 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. The failure to change the
regulations would leave in place a prescriptive regulatory regime for
process controls and PQC programs that also conflicts 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 responsibility includes 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, including having
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 likely
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. (As mentioned previously, the final rule ``Irradiation of
Meat Food Products'' removed requirements for poultry irradiation QC
programs.) This option provides establishments with the most

[[Page 34387]]

flexibility in implementing process control programs in a HACCP
environment.
This final rule will 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 will be to increase the
flexibility establishments have in controlling their processes. This
benefit arises from eliminating the required PQC program elements in
Secs. 318.4(d) and 381.145(d).
With or without this final rule, establishment HACCP plans will
supersede or incorporate the few PQC programs that control food safety
factors. Under the final rule, most establishments that have PQC
programs that control for non-food safety factors will continue to use
the programs. In all likelihood, in developing new PQC programs, they
will continue to include the information now required by FSIS. They
will 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 are likely to change their PQC-controlled operations
to coordinate their food quality process control more effectively with
their HACCP system operations to improve overall efficiency. Thus, raw
material control, which has been a required element in PQC programs,
could be handled under a HACCP plan with a CCP for raw materials, and
other process controls for food safety could be handled in the same
manner. 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 final rule will 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 will continue the use of QC
methods in their operations, so the removal of the regulatory
requirement for establishments to follow the regulatory design
specifications will 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, may
benefit from shifting some portion of their PQC program development and
operation costs into HACCP-related or other activities.
Also, under the final rule, 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 will not be a direct savings from the removal
of the regulatory requirements governing PQC programs, the industry
potentially will be able to make more efficient and effective use of
the $1 million or so in annual costs of developing the programs.
Finally, the final rule will 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 final rule will
not have a significant effect on a substantial number of small
entities. The final rule will affect about 72 poultry slaughtering
establishments, most of which are large business enterprises. It also
will 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 rule will not have a
significant effect on these establishments. It will 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 final rule will remove the remaining requirements for
establishments to have PQC programs for certain products or processes
and the general requirement concerning the design of such programs. The
final rule will 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 final rule will
theoretically provide several thousand dollars of regulatory relief
annually per establishment.
The final rule will 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) will 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 will 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 will save
about $520 per PQC program in development costs for 310 mandatory PQC
programs, or $161,720 total. Out of this total, small establishments
will save about $151,320.
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,

[[Page 34388]]

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
will 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 or special facilities that may be required to
determine whether products are in compliance with the regulations),
each establishment will save about $3,600 in PQC program operations.
In addition, small establishments will benefit from savings (at the
rate of $300 per establishment) that accrue from the removal of
regulatory design requirements for both mandatory and voluntary PQC
programs. They will have flexibility to develop and implement HACCP-
consistent or other process control systems, beyond the flexibility
that was provided by the FSIS final rule that removed prior approval
requirements for blueprints, equipment, and certain PQC programs (62 FR
45016; August 25, 1997).
Thus, at least $3,900 in recurring savings is available to each
small meat and poultry establishment. However, because many, if not
most, affected establishments will 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 savings that
could result from adopting alternatives to their PQC programs. The
effect of the final rule on the substantial number of affected small
establishments is therefore not likely to be significant.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking or packaging
requirements on federally inspected meat and meat products or poultry
products that are in addition to, or different than, those imposed
under the FMIA and PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat or poultry products that are misbranded or
adulterated under the FMIA or PPIA, or, in the case of imported
articles, which are not at such an establishment, after their entry
into the United States.
This final rule is not intended to have retroactive effect.
There are no applicable administrative procedures that must be
exhausted prior to any judicial challenge to the provisions of this
final rule. However, the administrative procedures specified in 9 CFR
381.35 must be exhausted prior to any judicial challenge of the
application of the provisions of this final rule, if the challenge
involves any decision of an FSIS employee relating to inspection
services provided under the FMIA or PPIA.

Executive Order 12898

Pursuant to Executive Order 12898 (59 FR 7629; February 16, 1994),
``Federal Actions to Address Environmental Justice in Minority and Low-
Income Populations,'' FSIS has considered potential impacts of this
final rule on environmental and health conditions in low-income and
minority communities.
This final rule will remove the requirements pertaining to PQC
programs in federally inspected meat and poultry establishments. It
will also remove from the canning regulations all requirements
concerning PQC programs, the requirements for case-by-case FSIS
approval of systems and devices not specified in the regulations, and
several other prior-approval requirements.
As explained in the economic impact analysis, the regulations
should generally benefit firms that process meat, meat food products,
and poultry products. The regulations will not require or compel meat
or poultry establishments to relocate or alter their operations in ways
that could adversely affect the public health or environment in low-
income and minority communities. Further, this final rule will not
exclude any persons or populations from participation in FSIS programs,
deny any persons or populations the benefits of FSIS programs, or
subject any persons or populations to discrimination because of their
race, color, or national origin. The benefits of this final rule from
ensuring that products are not adulterated or misbranded will accrue to
the members of all classes of the public, including minorities, women,
and persons with disabilities.
About 4 percent of official meat and poultry establishments are
under female or minority ownership. FSIS does not believe that the
effects of this rulemaking, whether beneficial or adverse, on such
establishments will be disproportionate. however, the Agency welcomes
any data or information that would contribute to an understanding of
the effects of this rule on minorities, women, or persons with
disabilities.

Additional Public Notification

Public awareness of all stages of rulemaking and policy development
is important. Consequently, in an effort to better ensure that
minorities, women, and persons with disabilities are aware of this
final rule, FSIS will announce it and provide copies of this Federal
Register publication in the weekly FSIS Constituent Update. FSIS
communicates the Constituent Update by fax to over 300 organizations
and individuals. In addition, the update is available on line through
the FSIS web page located at ``http://www.fsis.usda.gov''. The update
is used to provide information regarding FSIS policies, procedures,
regulations, Federal Register notices, FSIS public meetings, recalls,
and other information that could affect or would be of interest to the
Agency's constituents/stakeholders. The constituent fax list consists
of industry, trade, and farm groups, consumer interest groups, allied
health professionals, scientific professionals, and other individuals
who have requested to be included. Through these various channels, FSIS
is able to provide information to a much broader, more diverse
audience. For more information and to be added to the constituent fax
list, readers of this document may fax their requests to the
Congressional and Public Affairs Office, at (202) 720-5704.

Paperwork Requirements

Title: Processing Procedures and Quality Control Systems.
Type of Collection: Revision.
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this final rule in accordance with the Paperwork
Reduction Act. This final rule will substantially reduce reporting
requirements for official establishments. The final rule will 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 0583-0089.

[[Page 34389]]

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, Incorporation by reference, Meat inspection.

9 CFR Part 381

Poultry and poultry products, Reporting and recordkeeping
requirements.

9 CFR Part 424

Food additives, Food packaging, Meat inspection, Poultry and
poultry products.

For the reasons set forth in the preamble, FSIS is amending 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 continues 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 is 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 continues 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 is removed and reserved.

5. In Sec. 318.305, paragraph (d)(5) is removed, and paragraphs
(a)(1)(ii), (a)(2)(ii), and (f) are revised to read as follows:


Sec. 318.305 Equipment and procedures for heat processing systems.

(a) * * *
(1) * * *
(ii) Other devices. Temperature-indicating devices, such as
resistance temperature detectors, used in lieu of mercury-in-glass
thermometers, shall meet known, accurate standards for such devices
when tested for accuracy. The records of such testing shall be
available to FSIS program employees.
(2) * * *
(ii) Other devices. Temperature/time recording devices or
procedures used in lieu of chart-type devices must meet known accurate
standards for such devices or procedures when tested for accuracy. Such
a device must be accurate enough for ensuring that process time and
temperature parameters have been met.
* * * * *
(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.
* * * * *
6. Paragraph (b) of Sec. 318.307 is 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 that will ensure compliance with the applicable
requirements of Sec. 318.306.
* * * * *

7. In Sec. 318.308, paragraph (b) is revised, paragraph (c) is
removed and reserved, and paragraph (d) introductory text is revised to
read as follows:


Sec. 318.308 Deviations in processing.

* * * * *
(b) Deviations in processing (or process deviations) must be
handled according to:
(1)(i) A HACCP plan for canned product that addresses hazards
associated with microbial contamination, or
(ii) Paragraph (d) of this section.
(c) [Reserved]
(d) Alternative procedures for handling process deviations.
* * * * *

8. In Sec. 318.309, paragraph (a) is revised, paragraphs (b) and
(c) are removed and reserved, and paragraph (d) introductory text is
revised, to read as follows:


Sec. 318.309 Finished product inspection.

(a) Finished product inspections must be handled according to:
(1) A HACCP plan for canned product that addresses hazards
associated with microbiological contamination;
(2) An FSIS-approved total quality control system;
(3) Alternative documented procedures that will ensure that only
safe and stable product is shipped in commerce; or
(4) Paragraph (d) of this section.
(b) [Reserved]
(c) [Reserved]
(d) Alternative procedures for handling finished product
inspections.
* * * * *

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

9. 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.


10. Paragraph (e)(2) of Sec. 319.5 is 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,
D.C., 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,'' Chapter
39 and Chapter 45, subsection 45.2.06 (AOAC Official Method 940.33),
16th edition, 1995, are 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]

11. Section 319.104 is amended in paragraph (a) by removing the
last sentence of footnote 3 to the chart.


Sec. 319.105 [Amended]

12. Section 319.105 is amended in paragraph (a) by removing the
last sentence of footnote 2 to the chart.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

13. 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.


[[Page 34390]]



14. Section 381.76 is amended follows:
a. Paragraph (b)(1)(ii)(b) is revised.
b. Paragraph (b)(1)(iii)(b) is revised.
c. Paragraph (b)(4)(i)(a) introductory text is revised.
d. Paragraph (b)(4)(i)(b) is revised.
e. Paragraph (b)(4)(ii) is removed and reserved.
f. Paragraph (b)(4)(iii) is removed and reserved.
g. Paragraph (b)(5)(i)(a) introductory text is revised.
h. Paragraph (b)(5)(i)(b) is revised.
i. Paragraph (b)(5)(ii) is removed and reserved.
j. Paragraph (b)(5)(iii) is removed and reserved.
k. Paragraph (c) is removed.
The revisions 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, 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]

15. Paragraph (b) of Sec. 381.121d is amended by removing the comma
and all words following the word ``person.''


Sec. 381.145 [Amended]

16. Paragraphs (d) and (e) of Sec. 381.145 are removed and
reserved.
17. In Sec. 381.305, paragraph (d)(5) is removed, and paragraphs
(a)(1)(ii), (a)(2)(ii), and (f) are 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.
(2) * * *
(ii) Other devices. Temperature/time recording devices or
procedures used in lieu of chart-type devices must meet known accurate
standards for such devices or procedures when tested for accuracy. Such
a device must be accurate enough for ensuring that process time and
temperature parameters have been met.
* * * * *
(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.
* * * * *

18. Paragraph (b) of Sec. 381.307 is 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.
* * * * *

19. In Sec. 381.308, paragraph (b) is revised, paragraph (c) is
removed and reserved, and paragraph (d) introductory text is revised to
read as follows:


Sec. 381.308 Deviations in processing.

* * * * *
(b) Deviations in processing (or process deviations) must be
handled according to:

[[Page 34391]]

(1) A HACCP plan for canned product that addresses hazards
associated with microbial contamination; or
(2) Paragraph (d) of this section.
(c) [Reserved]
(d) Alternative procedures for handling process deviations.
* * * * *

20. In Sec. 381.309, paragraph (a) is revised, paragraphs (b) and
(c) are removed and reserved, and paragraph (d) introductory text is
revised, to read as follows:


Sec. 381.309 Finished product inspection.

(a) Finished product inspections must be handled according to:
(1) A HACCP plan for canned product that addresses hazards
associated with microbiological contamination; or
(2) An FSIS-approved total quality control system; or
(3) Alternative documented procedures that will ensure that only
product that is safe and stable is shipped in commerce; or
(4) Paragraph (d) of this section.
(b) [Reserved]
(c) [Reserved]
(d) Alternative procedures for handling finished product
inspections.
* * * * *

PART 424--PREPARATION AND PROCESSING OPERATIONS

21. The authority citation for part 424 continues to read as
follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695;
7 CFR 2.18, 2.53.


22. In the table in Sec. 424.21(c), under the Class of substance
``Miscellaneous,'' the entry for the Substance ``Ascorbic acid,
erythorbic acid, citric acid, sodium ascorbate, and sodium citrate,
singly or in combination'' is revised to read as follows:


Sec. 424.21 Use of food ingredients and sources of radiation.

* * * * *
(c) * * *

----------------------------------------------------------------------------------------------------------------
Class of substance Substance Purpose Products Amount
----------------------------------------------------------------------------------------------------------------

* * * * * *
*
Miscellaneous........... Ascorbic acid, To delay Fresh beef cuts, Not to exceed, singly or in
erythorbic discoloration. fresh lamb combination, 500 ppm or 1.8 mg/
acid, citric cuts, and fresh sq inch of product surface of
acid, sodium pork cuts. ascorbic acid (in accordance
ascorbate and with 21 CFR 182.3013),
sodium citrate, erythorbic acid (in accordance
singly or in with 21 CFR 182.3041), or
combination. 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).

* * * * * * *
----------------------------------------------------------------------------------------------
* * * * *
23. In Sec. 424.22, paragraphs (b)(1)(ii)(A) and (B) are revised to
read as follows:


Sec. 424.22 Certain other permitted uses.

* * * * *
(b) * * *
(1) * * *
(ii) * * *
(A) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550
ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be
used; or
(B) 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.
* * * * *

Done at Washington, DC, on May 12, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-12659 Filed 5-26-00; 8:45 am]
BILLING CODE 3410-DM-P