[Federal Register Volume 65, Number 104 (Tuesday, May 30, 2000)]
[Rules and Regulations]
[Pages 34381-34391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12659]



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  Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / 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.

-----------------------------------------------------------------------

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