[Federal Register Volume 61, Number 86 (Thursday, May 2, 1996)]
[Proposed Rules]
[Pages 19564-19578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10796]



 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed 
Rules  

[[Page 19564]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 317, 318, 320, and 381

[Docket No. 95-033P]


Performance Standards for the Production of Certain Meat and 
Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the Federal meat and poultry inspection regulations by converting 
the current regulations governing the production of cooked beef 
products, uncured meat patties, and certain poultry products into 
performance standards. The proposed performance standards spell out the 
objective level of performance establishments must meet during their 
operations in order to produce safe products, but allow the use of 
plant-specific processing procedures other than the procedures 
prescribed in the current regulations.
    Performance standards set forth requirements in terms of what is to 
be achieved by a given regulatory requirement. They represent a shift 
in focus from ``command-and-control'' regulations in that they specify 
the ends to be achieved (producing safe meat and poultry products), but 
not the means to achieve those ends. The command-and-control provisions 
in the current regulations prescribe the means for producing safe meat 
and poultry products, specifying step-by-step procedures to be followed 
by establishments.
    All of the command-and-control provisions in the current 
regulations meet the proposed performance standards. FSIS proposes to 
maintain the current provisions in the regulations as examples of how 
an establishment might comply with the proposed performance standards 
(``safe harbors''). Therefore, establishments would not be required to 
change any current practices in response to this proposed rule.
    The specific categories of products affected follow: cooked beef, 
roast beef, and cooked corned beef; fully cooked, partially cooked, and 
char-marked uncured meat patties; and certain fully and partially 
cooked poultry products. Any establishment producing these products and 
choosing to develop and use procedures different from those provided in 
the safe-harbor example would be required to maintain on file a 
documented process schedule that has been approved by a process 
authority for safety and efficacy, as required by the performance 
standard. The process schedule would include control, monitoring, 
validation, and corrective action activities to be performed by the 
establishment.

DATES: Comments must be received on or before July 1, 1996.

ADDRESSES: Submit one original and two copies of written comments to 
Docket Clerk, U.S. Department of Agriculture, Food Safety and 
Inspection Service, Room 4352-S, Washington, DC 20250-3700. Please 
refer to docket number 95-033P in your comments. Any person desiring an 
opportunity for oral presentation of views as provided under the 
Poultry Products Inspection Act should contact Dr. Paula M. Cohen at 
(202) 720-7164 so that arrangements can be made. All comments submitted 
in response to this proposal will be available for public inspection in 
the Docket Clerk's Office between 8:30 a.m. and 1:00 p.m., and 2:00 
p.m. and 4:30 p.m., Monday through Friday. To review the research and 
other background information used by FSIS in developing this document, 
persons may visit the Docket Clerk's office during the times listed 
above.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Acting Deputy 
Administrator, Science and Technology, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250-3700; 
(202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

    Under the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.) 
and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.), 
FSIS issues regulations governing the production of meat and poultry 
products prepared for distribution in interstate and foreign commerce. 
Many of these regulations employ the command-and-control approach, 
prescribing a precise sequence of steps to be followed to produce food 
that is safe and not adulterated.
    Since 1972, FSIS has promulgated several regulations ensuring the 
safety of various cooked and partially cooked meat and poultry 
products. These regulations (9 CFR 318.17, 318.23, and 381.150) 
prescribe specific steps establishments must follow to ensure harmful 
bacteria are killed, growth of spore-forming bacteria is controlled, 
and recontamination of the product is prevented. By describing detailed 
safety procedures, this approach to rulemaking has provided clear 
direction and ensured that all establishments are subject to the same 
rules.
    However, command-and-control regulations often do not account for 
the uniqueness of individual processing procedures and needs within 
different establishments. FSIS command-and-control regulations require 
all establishments to produce meat and poultry products in the same 
manner. Such prescriptive regulations are burdensome in many settings.
    Further, command-and-control regulations can have disparate 
economic effects on establishments producing different volumes of the 
same product. By mandating the use of specific processes or 
technologies, FSIS often inadvertently imposes economic burdens on 
small businesses. Small establishments producing meat and poultry 
products at low volumes often must pay a high cost per product unit 
when required to employ a specific process or technology, while large 
establishments are able to spread the cost over their higher production 
volumes.
    FSIS is now proposing to convert these regulations to performance 
standards. Performance standards spell out the objective level of 
performance establishments must meet during their operations in order 
to produce safe and nonadulterated products, but allow the use of 
plant-specific processing procedures, other than those prescribed in 
the current regulations. Accordingly, establishments could employ 
innovative or unique processing procedures customized to the nature and 
volume of their production.

[[Page 19565]]

    The conversion of command-and-control regulations to performance 
standards is also an important element of the Agency's HACCP (Hazard 
Analysis and Critical Control Points) initiative.

Performance Standards and HACCP

    In the Federal Register of February 3, 1995 (60 FR 6774), FSIS 
described a new food safety strategy based on clearly defining the 
responsibility of meat and poultry establishments to produce products 
that meet FSIS-established food safety performance standards. As a 
central element of this new food safety strategy, FSIS has proposed 
that all establishments adopt the science-based system of preventive 
controls to ensure food safety, known as HACCP. Under HACCP, 
establishments will be responsible for developing and implementing 
HACCP plans incorporating the controls determined by the establishment 
to be necessary and appropriate to produce safe products. HACCP is a 
flexible system that enables establishments to tailor their control 
systems to the needs of particular plants and processes.
    Clearly defined food safety performance standards and HACCP are 
both powerful tools for improving food safety. Under FSIS proposals to 
implement performance standards and HACCP, establishments would have 
the incentive and flexibility to adopt innovative, science-based food 
safety processing procedures and controls. Furthermore, by focusing on 
inspectional oversight of the manner in which establishments are 
implementing HACCP plans and achieving performance standards, FSIS will 
have a more effective means of ensuring that establishments are meeting 
their food safety responsibilities.
    Moreover, for HACCP to be successful, FSIS must reconsider its 
current reliance on command-and-control regulations. As a general 
matter, such regulations are incompatible with HACCP and the new food 
safety strategy because they deprive plants of the flexibility to 
innovate, one of the advantages of HACCP, and undercut the clear 
delineation of responsibility for food safety on which the FSIS 
strategy is based. Therefore, to prepare for the implementation of 
HACCP, FSIS is conducting a thorough review of its current regulations 
and, to the maximum extent possible, converting its command-and-control 
regulations to performance standards. This proposal to convert the 
current regulations governing the production of certain cooked beef 
products, uncured meat patties, and certain poultry products into 
performance standards is an important part of this effort.

The Integration of Performance Standards Into Establishment HACCP Plans

    Establishments would have the option of developing customized 
processing procedures designed to meet performance standards prior to 
their implementation of the HACCP requirements. These establishments 
would incorporate elements of their customized processing procedures 
into their HACCP plans and, in fact, probably would develop these 
processing procedures with HACCP in mind. Specifically, establishments 
would incorporate the means they use to meet the performance standards 
into their HACCP plans as critical limits.
    When developing a HACCP plan, an establishment must first carry out 
a hazard analysis to identify and list the physical, biological, or 
chemical food safety hazards reasonably likely to occur in the 
production process for a particular product and the preventive measures 
necessary to control the hazards. The establishment then must identify 
the critical control points (CCPs) in each of its processes. A CCP is 
a point, step, or procedure at which control can be applied and a food 
safety hazard can be prevented, eliminated, or reduced to an acceptable 
level.
    Next, the critical limits for preventive measures associated with 
each identified CCP must be established. A critical limit is the 
maximum or minimum value to which a process control measure must be 
controlled at a CCP to prevent, eliminate, or reduce to an acceptable 
level the identified food safety hazard. Critical limits are most often 
based on process parameters such as temperature, time, water activity, 
or humidity. Critical limits must be designed to satisfy relevant FSIS 
regulations (including performance standards), FDA tolerances, and 
action levels where appropriate.
    The proposed performance standards set out quantifiable 
microbiological pathogen reduction requirements for cooked beef 
products, uncured meat patties, and certain fully and partially cooked 
poultry products. Therefore, establishments would develop critical 
limits based upon these performance standards. Of course, during hazard 
analysis, establishments probably would identify other hazards not 
addressed by these performance standards and would be required to 
develop CCP's and critical limits accordingly. An example of how an 
establishment might use performance standards to develop critical 
limits follows.
    Establishment X produces ready-to-eat poultry products and, as a 
result of this proposal, would be required to meet three performance 
standards: lethality, stabilization, and handling. To meet the 
lethality standard, the establishment must achieve a 7-D reduction in 
the microbiological pathogen Salmonella (explained below) in their 
poultry products. As would most, if not all establishments, 
Establishment X achieves this reduction in Salmonella through cooking. 
Establishment X cooks its poultry at 155  deg.F for 16 seconds to 
achieve a 7-D lethality.
    As part of its HACCP plan, Establishment X must develop critical 
limits for the preventive measures addressing the hazards associated 
with producing ready-to-eat poultry products. Salmonella is identified 
as one of those hazards by the lethality performance standard. 
Therefore, Establishment X would incorporate the time/temperature 
combination used to meet the lethality performance standard into its 
HACCP plan as critical limits.
    To meet the second performance standard, stabilization, 
Establishment X must prevent the germination and multiplication of 
toxigenic microorganisms such as C. botulinum and allow no more than a 
1-decimal log multiplication of C. perfringens within its ready-to-eat 
poultry products (further explained below). To meet this performance 
standard, Establishment X decides to chill its poultry products 
following cooking, to 80  deg.F within 1.5 hours and to 40  deg.F 
within 5 hours. C. botulinum and C. perfringens are identified by the 
stabilization performance standard as hazards that must be addressed 
during the production of ready-to-eat poultry products. Therefore, 
Establishment X would incorporate the time/temperature combination used 
to meet the stabilization performance standard into its HACCP plan as 
critical limits.
    To meet the third performance standard for ready-to-eat poultry, 
handling, Establishment X must ensure that no infectious pathogens are 
introduced into the product following processes ensuring lethality and 
stabilization and after final packaging. To meet the handling standard, 
Establishment X cooks the packaged, raw poultry product in a room 
physically separated from other rooms in which raw poultry and 
ingredients are handled and packaged. Further, Establishment X assures 
that raw materials entering the room for processing are stored 
separately from the finished, ready-to-eat product. Finally, 
Establishment X monitors the integrity of the packaged, ready-to-eat

[[Page 19566]]

product to ensure that there are no punctures or incomplete seals that 
may cause contamination.

The Proposed Performance Standards and Commercial Sterility

    As stated above, the performance standards proposed set out 
quantifiable pathogen reduction requirements for cooked beef products, 
uncured meat patties, and certain fully and partially cooked poultry 
products. In the interest of further simplifying the food safety 
regulations governing these products, FSIS might have proposed a single 
performance standard: commercial sterility, or the elimination of all 
microorganisms from these products.
    However, achieving commercial sterility within cooked beef 
products, uncured meat patties, and certain fully and partially cooked 
poultry products would not be feasible. It would be technically 
impossible for establishments to produce versions of these products 
that are both commercially sterile and marketable. For example, using 
current technology, it would be impossible to produce a ready-to-eat, 
rare roast beef product that is commercially sterile.
    The quantifiable pathogen reduction performance standards proposed 
for these products would both ensure the production of safe food, with 
an ample margin of safety, and be readily achievable by industry. 
Further, as explained in the following section, these proposed 
performance standards are intrinsic to the current regulations.

Safe Harbors

    Products produced in accordance with the command-and-control 
provisions in the current regulations governing cooked beef products, 
uncured meat patties, and certain fully and partially cooked poultry 
products would meet the proposed performance standards. Establishments 
producing these products therefore would not be required to change any 
current practices in response to this proposed rule. By proposing 
performance standards that may be met through adherence to the current 
regulations, FSIS creates a regulatory ``safe harbor'' for 
establishments that wish to continue operating as is currently 
required.
    FSIS proposes to retain these regulatory safe harbors in the Code 
of Federal Regulations (CFR), as examples of how establishments can 
produce cooked beef products, uncured meat patties, and certain fully 
and partially cooked poultry products that meet the performance 
standards. Such examples would assist small or new establishments that 
do not have the resources to develop customized process schedules for 
these products. Though these regulatory safe harbors contain many 
prescriptive and possibly obsolete requirements, the Agency wants to 
provide options that allow establishments to continue operating as they 
do under the current regulations. Therefore, in this proposal, the 
regulatory safe harbors are presented with few changes from the current 
regulations.
    FSIS has announced a comprehensive review of regulatory procedures 
and requirements to determine which are still needed and which ought to 
be reconsidered, streamlined, or eliminated. As well as identifying 
regulatory candidates for reform and repeal in general, this review 
will establish priorities for revising regulations for compatibility 
with HACCP and the new FSIS food safety strategy. As explained above, 
under the new food safety strategy and HACCP, establishments will be 
responsible for developing and implementing HACCP plans incorporating 
the controls determined by the establishment to be necessary and 
appropriate to produce safe products.
    Many of the command-and-control provisions, inherent in the current 
regulations and thus in the proposed safe harbors, must therefore be 
eliminated, revised, or converted to performance standards. Command-
and-control regulations are generally incompatible with HACCP and the 
new food safety strategy because they deprive establishments of the 
flexibility to innovate and undercut the clear delineation of 
responsibility for food safety on which the FSIS strategy is based. 
FSIS will focus its review of the proposed regulatory safe harbors on 
the most prescriptive provisions, especially those concerning prior 
approval of customized processes or product disposition by FSIS program 
officials. These prior approval requirements would be incompatible with 
FSIS inspection under HACCP and would need to be eliminated before 
HACCP implementation. Further, FSIS proposes to retain the safe harbors 
only as examples of processes establishments can use to produce product 
meeting the performance standard.
    The safe harbors included in this proposal still contain provisions 
requiring prior approval by FSIS program officials of customized 
processes or product disposition. As stated above, FSIS must remove 
these provisions prior to the implementation of HACCP. FSIS invites 
comment on precisely how safe harbors should be revised in light of 
HACCP and the new FSIS food safety strategy. FSIS also invites comment 
on whether the Agency should provide regulatory safe harbors at all, 
and if so, whether their retention in the Code of Federal Regulations 
is necessary.

Process Schedule Approval and Validation

    Prior to its development and implementation of a HACCP plan, an 
establishment choosing to develop and use processing procedures 
different from those provided in the safe-harbor examples would be 
required to have on file, available to FSIS, a written process schedule 
describing the specific operations employed by the establishment to 
accomplish the objectives of the performance standards (FSIS would 
amend the relevant information requirements in 9 CFR part 320). This 
process schedule also would be required to contain the related control, 
monitoring, validation, and corrective action activities associated 
with the establishment's procedures. These activities are the good 
sanitation and basic good manufacturing practices generally regarded as 
essential prerequisites for the production of safe food. Further, these 
activities would be similar, if not identical, to the control, 
monitoring, validation, and corrective action activities developed by 
the establishment as part of its HACCP plan. Accordingly, so not to 
place duplicative requirements on establishments, FSIS would sunset 
these process schedule requirements as HACCP is implemented.
    The process schedule would have to be evaluated and approved for 
safety and efficacy by a process authority. FSIS does not propose to 
preapprove the procedures deemed acceptable by the establishment's 
process authority. The proposed regulations define a process authority 
as a person or organization with expert knowledge in meat and poultry 
process control and relevant regulations.
    The process authority would evaluate the establishment's 
prospective processing procedures and, after using such devices as 
laboratory challenge studies or comparison to peer-reviewed and -
accepted procedures, approve, in writing, the safety and efficacy of 
the establishment's prospective procedures. The process authority must 
have access to the establishment in order to evaluate the safety of 
that establishment's planned production processes.
    As stated above, FSIS proposes to sunset these proposed process 
schedule requirements as establishments develop and implement HACCP 
plans. These requirements would be duplicative of

[[Page 19567]]

what is required by HACCP, that is, an establishment would not need 
both an approved process schedule and a validated HACCP plan for the 
same process. FSIS anticipates that if an establishment developed a 
process schedule for producing one of the aforementioned meat or 
poultry products prior to implementing HACCP, it would incorporate 
elements of that process schedule into its HACCP plan.
    Also, FSIS proposes to require that prior to the implementation of 
HACCP, establishments validate the process schedule by testing product 
to determine that it meets the applicable performance standards. 
Testing would have to be conducted in accordance with a sampling 
program designed by the process authority to assure, with at least 95 
percent statistical confidence, that an establishment's process 
schedule will produce product that meets applicable performance 
standards. Establishments could not release product for commercial use 
until testing confirmed that the process schedule was producing product 
meeting applicable performance standards. FSIS would require that 
results of the product testing, as well as the sampling regimen, be 
made available as the validation activities contained in the process 
schedule.
    It is an industry convention to confirm that new production 
processes are safe and effective by holding and testing product prior 
to its commercial release. Therefore, FSIS believes that this proposed 
testing requirement for customized and essentially new process 
schedules would not be burdensome for meat and poultry establishments.
    Validation of process schedules through sampling prior to the 
implementation of HACCP is a necessary step establishments must take to 
ensure that their processes are producing safe food for commercial 
distribution. FSIS realizes, however, that this particular form of 
validation may not be appropriate in every circumstance. Therefore, 
FSIS invites comment on the validation requirement proposed in this 
document, specifically as to whether FSIS should prescribe this 
specific method of validation for these process schedules, and, whether 
the proposed testing requirement is in fact appropriate for ensuring 
that an establishment's products meet food safety performance 
standards.
    Like the proposed requirements concerning the development, 
approval, and maintenance of the process schedule, the process schedule 
validation requirement would be sunsetted as HACCP is implemented. FSIS 
would not require an establishment with a validated HACCP plan 
producing meat and poultry products that meet performance standards 
also to have on file a validated process schedule.

FSIS Inspection

    After a process authority has approved an establishment's planned 
procedures and before the production of lots to be held and tested, an 
establishment would be required to notify FSIS that it is implementing 
procedures different than those contained in the safe harbor provisions 
of the regulations. This notification would facilitate FSIS inspection 
in regard to these procedures. FSIS personnel would continue to perform 
inspection tasks as scheduled by the Performance Based Inspection 
System, as they do under the current regulations, in order to verify 
that the product is processed according to the procedures on file and 
meets the performance standards. FSIS in-plant inspection personnel 
would not be evaluating the process authority-approved procedures for 
efficacy, except through these in-plant verification tasks. FSIS 
inspection of an establishment employing process authority-approved 
procedures would be as rigorous as inspection of an establishment 
employing safe-harbor procedures.
    At all establishments, FSIS personnel would retain the authority to 
sample product for verification or to take action on the process in 
cases where noncompliance with Agency regulations is suspected or when 
the process is not properly controlled. FSIS personnel would sample 
products made with process authority-approved procedures at the same 
frequency they sample products made with safe-harbor procedures.
    Should an establishment wish to alter its approved procedures, the 
process authority must evaluate and approve, in writing, the proposed 
alterations prior to their implementation. The process authority would 
approve only alterations that result in the continued production of 
product meeting performance standards. Prior to the commercial release 
of any product produced by process authority-approved, altered 
procedures, testing requirements would again apply.
    It is possible that the same process authority may service several 
establishments owned by a single company. The process authority could 
approve the same procedures for use at all of the establishments. FSIS 
would allow such an arrangement, as long as the process authority-
approved procedure is on file at each establishment and each 
establishment complies with the applicable testing provisions for the 
product in question.
    Any establishment operating under a Total Quality Control (TQC) 
system (Sec. 318.4) and desiring to employ a processing procedure 
approved by a process authority would be required to submit the 
approved procedure through normal channels for incorporation into its 
TQC system. FSIS would evaluate only the format of the approved 
procedure, to allow its incorporation into the official FSIS-held 
copies of the TQC system procedures.

Performance Standards for Cooked/Roast Beef Products, Cooked Uncured 
Meat Patties, and Certain Cooked Poultry Products

    To meet the proposed performance standards for cooked/roast beef 
products, fully cooked, uncured meat patties, and certain fully cooked 
poultry products, establishments would need to continue to eliminate 
pathogenic microorganisms from these products. FSIS is proposing three 
performance standards reflecting this goal: lethality, stabilization, 
and handling. An establishment meeting these three standards would 
produce ready-to-eat, cooked products containing no viable pathogenic 
microorganisms.

Lethality

    To meet the first standard, lethality, establishments must treat 
ready-to-eat product so as to ensure a specific, significant reduction 
in the number of pathogenic microorganisms in the product, effectively 
eliminating the pathogenic microorganisms from the product. FSIS is not 
proposing to require that any particular means be used to meet the 
lethality standard. For these cooked products, FSIS would continue to 
require a heat treatment. However, FSIS is not proposing to require 
that cooking be the sole means by which lethality is to be achieved. 
Other applicable treatments, such as curing, might be used in 
combination with cooking to achieve the required lethality.
    For the purpose of the lethality standard, reduction of pathogenic 
microorganisms would be measured in D-values. A D-value indicates the 
time required to reduce the viable microbial population by one 
log10 unit at a given temperature:

D=t/log a-log b

where ``t'' is the time of heating, ``a'' the number of viable 
organisms at ``t''=0 minutes, and ``b'' the number of surviving 
organisms. A ``7-D'' process for Salmonella, for example, would

[[Page 19568]]

reduce Salmonella contamination by a factor of 10 million and would 
ensure the effective elimination of Salmonella in a product 
contaminated with as many as 10 million (107) organisms per gram.
    For cooked beef, roast beef, and cooked corned beef products, FSIS 
is proposing that the lethality performance standard be a 7-D reduction 
in Salmonella. Traditionally, the pathogenic microorganism of concern 
in cooked beef products has been Salmonella. Although E. coli 0157:H7 
has emerged as a significant pathogen of concern in meat products, 
Salmonella is generally slightly more resistant to heat than E. coli 
0157:H7. Furthermore, while Salmonella is not as heat resistant as 
Listeria monocytogenes, the presence of L. monocytogenes in finished 
product is primarily a result of recontamination and the expected 
levels of L. monocytogenes are much lower than those expected of 
Salmonella. Therefore, the thermal destruction of Salmonella in cooked 
beef products would indicate the destruction of the other two 
pathogens. (To review the research and other background information 
used by FSIS in developing this document, see ADDRESSES above.)
    When the current regulations for cooked beef products were 
promulgated, available research indicated that due to the 
microbiological profile of beef and other factors, a 7-D reduction in 
Salmonella was necessary to produce a safe cooked beef product, free of 
pathogens. A 7-D reduction in Salmonella does effectively eliminate all 
pathogenic microorganisms from cooked beef products and provides a 
significant margin of safety. However, the Agency recognizes that the 
required 7-D reduction in Salmonella may be overly conservative in 
certain processing environments. For example, if an establishment with 
an effective system of process controls were processing high quality 
raw product into roast beef, it might not need to achieve a 7-D 
reduction in Salmonella in order to produce safe product. Given the 
variety of establishments producing cooked beef products, however, 
requiring a 7-D reduction of Salmonella in these products provides for 
a significant margin of safety throughout the industry.
    FSIS also recognizes that developments in processing technology now 
may indicate that a safe, ready-to-eat cooked beef product could be 
produced with a different level of lethality. Raw beef is rarely 
contaminated with Salmonella at levels in excess of three or four logs 
(1,000-10,000 organisms) per gram of product. It is thus probable that 
a 3-D or 4-D reduction in Salmonella would effectively eliminate all 
pathogens from a cooked beef product.
    The Agency invites submissions on this lethality standard. FSIS 
would consider revising the lethality performance standard and safe 
harbor example for cooked beef products in general if presented with 
compelling data. FSIS also might consider revising the lethality 
performance standard for cooked beef products produced under certain 
combinations of conditions, such as those presented in the example 
above. Such revisions would grant further flexibility to cooked beef 
processors and encourage innovation, while ensuring the safety of the 
food produced.
    The current regulations in Sec. 318.17, governing the production of 
cooked beef, roast beef, and cooked corned beef products, require, 
among other things, that these products be cooked at certain 
temperatures for certain periods of time (the table in paragraph (a) of 
Sec. 318.17 lists the approved time/temperature combinations). When 
applied, all of these time/temperature combinations produce a 7-D 
lethality. Therefore, as a result of this proposal, establishments 
continuing to follow the current regulations (the proposed safe 
harbors) would produce cooked beef products that meet the 7-D lethality 
standard presented in this document. And, notably, establishments that 
choose to produce cooked beef products using procedures other than 
those retained in the safe harbor regulations would be required to meet 
the same rigorous measure of lethality.
    For fully cooked, uncured meat patties, FSIS is proposing that the 
lethality performance standard be a 5-D reduction in Salmonella. FSIS 
has identified Salmonella as the target pathogenic microorganism in 
fully cooked uncured meat patties, as in fully cooked beef products, 
because its elimination indicates the elimination of other pathogenic 
microorganisms. A 5-D reduction in Salmonella in cooked, uncured meat 
patties effectively eliminates all pathogenic microorganisms, provides 
a significant margin of safety, and allows for the production of a 
marketable product (achieving a 7-D reduction of Salmonella in fully 
cooked meat patties, as is mandated for cooked beef or poultry 
products, would require a degree of processing that would render the 
patties burnt, dry, and unacceptable to consumers).
    As in the cooked beef product regulations, the regulations in 
Sec. 318.23 governing the production of cooked, uncured meat patties 
require that these products be cooked at certain temperatures for 
certain periods of time (Table A, in paragraph (b)(1)(i) of Sec. 318.23 
lists the approved time/temperature combinations). When applied, all of 
these time/temperature combinations produce a 5-D lethality. Therefore, 
as a result of this proposal, establishments continuing to follow the 
current regulations (the proposed safe harbors) would produce cooked 
meat patties that meet the 5-D lethality standard proposed in this 
document. And, establishments that choose to produce cooked meat 
patties using procedures other than those retained in the safe harbor 
regulations would be required to meet the same rigorous measure of 
lethality.
    For the cooked poultry products described in Sec. 381.150, FSIS is 
proposing that the lethality performance standard be a 7-D reduction in 
Salmonella. FSIS has identified Salmonella as the target pathogenic 
microorganism in cooked poultry products, as in fully cooked beef and 
uncured meat patties, because its elimination indicates the elimination 
of other pathogenic microorganisms. When the current regulations for 
cooked poultry products were promulgated, available research indicated 
that due to the microbiological profile of poultry and other factors, a 
7-D reduction in Salmonella was necessary to produce a safe cooked 
poultry product, free of pathogens. (To review the research and other 
background information used by FSIS in developing this document, see 
ADDRESSES above.) A 7-D reduction in Salmonella does effectively 
eliminate all pathogenic microorganisms from cooked poultry products 
and provides a significant margin of safety.
    The Agency recognizes that the required 7-D reduction in Salmonella 
may be overly conservative in certain processing environments. For 
example, if an establishment with an effective system of process 
controls were processing high quality raw product into ready-to-eat 
cooked poultry, it might not need to achieve a 7-D reduction in 
Salmonella in order to produce safe product. Given the variety of 
establishments producing cooked poultry products, however, requiring a 
70D reduction of Salmonella in these products provides for a 
significant margin of safety throughout the industry.
    Further, FSIS recognizes that developments in processing technology 
now may indicate that in general, safe, ready-to-eat cooked poultry 
products could be produced with a different level of lethality. It is 
possible, for example, that a 3-D or 4-D reduction in

[[Page 19569]]

Salmonella would effectively eliminate all pathogens from cooked 
poultry products.
    The Agency invites submissions on the lethality standard for cooked 
poultry products. FSIS would consider revising the lethality 
performance standard and safe harbor example for cooked poultry 
products in general if presented with compelling data. FSIS also might 
consider revising the lethality performance standard for cooked poultry 
products produced under certain combinations of conditions, such as 
those presented in the example above.
    The regulations in Sec. 381.150(b) governing the production of 
cooked poultry products require that these products reach certain 
internal temperatures prior to being removed from the cooking medium. 
Meeting these internal temperature requirements ensures a 7-D reduction 
of Salmonella. Therefore, as a result of this proposal, establishments 
continuing to follow the current regulations (the proposed safe 
harbors) would produce cooked poultry products that meet the 7-D 
lethality standard proposed in this document. And, establishments that 
choose to produce cooked poultry products using procedures other than 
those retained in the safe harbor regulations would be required to meet 
the same rigorous measure of lethality.

Stabilization

    In order to meet the second performance standard, stabilization, 
establishments must prevent vegetative spore-forming bacteria from 
growing within product and producing toxin. If allowed to grow in 
number, these bacteria can produce high concentrations of toxin, which 
cause foodborne illness.
    Means applied to products to bring about the lethality of certain 
pathogenic microorganisms, such as Salmonella, can create a model 
environment for the multiplication of spore-forming bacteria. For 
example, cooking or heat processing is likely to be applied to a 
product in order to eliminate Salmonella and other pathogenic 
microorganisms. Clostridium botulinum spores, Clostridium perfringens 
spores, and spores from other vegetative and spore-forming bacteria can 
survive cooking and, in fact, thrive in the warm product following 
cooking when competitive microorganisms, such as Salmonella, have been 
eliminated.
    Therefore, it is important that the stabilization conditions are 
implemented so that vegetative, spore-forming bacteria do not have an 
opportunity to grow within the product. Accordingly, FSIS is proposing 
that stabilization, likely to be rapid cooling following cooking, must 
prevent the germination and multiplication of toxigenic microorganisms 
such as C. botulinum, and allow no more than a 1-decimal log 
multiplication of C. perfringens. Limiting the allowable growth of C. 
perfringens to a 1-decimal log multiplication would effectively limit 
the multiplication of other, slower growing spore-forming bacteria, 
such as Bacillus cereus and Staphylococcus aureus.
    The current regulations for cooked beef products and cooked meat 
patties require, among other things, that these cooked products be 
quickly cooled following cooking, in order to inhibit the growth of 
vegetative, spore-forming bacteria. Section 318.17(h)(10) requires that 
establishments begin chilling cooked beef products within 90 minutes of 
heat processing. The products must be chilled from 120  deg.F to 55 
deg.F in no more than 6 hours, chilling must continue until shipment, 
and the product cannot be packed for shipment until it has reached 40 
deg.F. Section 318.23(b) requires that cooked meat patties be cooled to 
an internal temperature of 40  deg.F or below within 2 hours of heat 
processing. When applied, the chilling requirements for both cooked 
beef products and cooked meat patties prevent the germination and 
multiplication of toxigenic microorganisms such as C. botulinum and 
allow no more than a 1-decimal log multiplication of C. perfringens, 
that is, they produce cooked products that meet the stabilization 
performance standard presented in this document.
    The chilling requirements for the cooked poultry products concerned 
in this proposal are not set out in the regulations for these products, 
Sec. 381.150, but instead in FSIS Directive 7110.3, ``TIME/TEMPERATURE 
GUIDELINES FOR COOLING HEATED PRODUCTS.'' This directive states that 
following heat treatment, cooked poultry products should be chilled to 
80  deg.F within 1.5 hours, and to 40  deg.F within 5 hours. When 
applied, this chilling prevents the germination and multiplication of 
toxigenic microorganisms such as C. botulinum and allows no more than a 
1-decimal log multiplication of C. perfringens, that is, it produces 
cooked poultry products that meet the stabilization performance 
standard presented in this document.
    Therefore, as a result of this proposal, establishments continuing 
to follow the current regulations regarding the chilling of cooked beef 
and meat patty products or the directive regarding the chilling of 
cooked poultry products (the proposed safe harbors) would produce 
cooked products that meet the stabilization standard for cooked 
products presented in this document. And, establishments that choose to 
produce cooked products using procedures other than those retained in 
the proposed safe harbors would be required to meet the same rigorous 
measure of stabilization.
    FSIS is proposing to amend the current regulations in Sec. 381.150 
(the proposed safe harbor for certain cooked poultry products) by 
adding the chilling requirements for cooked poultry currently contained 
in FSIS Directive 7110.3. This proposed amendment would help to clarify 
and complete in a single section of the Poultry Products Inspection 
Regulations the proposed safe harbor regulations for certain cooked 
poultry products.

Handling

    To meet the third performance standard for cooked products, 
establishments would need to handle product to preclude its 
recontamination by infectious pathogenic microorganisms. This standard 
requires that no infectious pathogens are introduced into the product 
following processes ensuring lethality, stabilization, or final 
packaging.
    The current regulations for cooked beef products and cooked meat 
patties require, among other things, that these cooked products be 
handled, throughout processing, in a manner precluding their 
recontamination by infectious pathogenic microorganisms. Section 
318.17, paragraphs (i), (j), and (k) require that establishments take 
various measures to ensure that cooked beef products are not 
recontaminated by contact with raw product, unsanitary work surfaces or 
machines, employee gloves or garments, and other sources of 
contamination. Section 318.23, paragraph (b)(4) requires establishments 
to take similar measures to ensure that cooked meat patties are not 
recontaminated.
    Therefore, as a result of this proposal, establishments continuing 
to follow the current regulations regarding handling of cooked beef and 
meat patty products (the proposed safe harbors) would produce cooked 
beef products and cooked meat patties that meet the handling standard 
for cooked products proposed in this document. And, establishments that 
choose to produce cooked beef products and cooked meat patties using 
procedures other than those retained in the proposed safe harbors would 
be required to meet the same rigorous measure of handling.

[[Page 19570]]

    Section 381.150 of the regulations contains no specific handling 
requirements for cooked poultry products. FSIS is proposing to amend 
the regulations contained in Sec. 381.150 by adding specific handling 
requirements for cooked poultry products. These proposed handling 
requirements are modeled after those currently in place for cooked beef 
products and cooked meat patties. Consequently, adherence to these 
proposed handling requirements for cooked poultry products would assure 
establishment compliance with the proposed handling performance 
standard. The addition of these handling requirements to the proposed 
regulatory safe harbor would clarify existing sanitation requirements 
and assist establishments that do not have the resources to develop 
customized process schedules for these products.
    FSIS experience with establishments producing the cooked poultry 
products defined under Sec. 381.150 indicates that the proposed 
handling requirements represent current good manufacturing practices 
(GMPs) accepted by industry. These handling GMPs, including the 
separation of raw and cooked product, sanitation of work surfaces, and 
appropriate packaging, are generally regarded as essential for 
preventing the direct and indirect contamination of cooked product.
    Poultry establishments already following the proposed handling safe 
harbor requirements would not have to change their handling procedures 
in order to meet the proposed handling performance standards. These 
establishments may wish to take advantage of the flexibility afforded 
by the proposed performance standards, however, and develop handling 
procedures that more closely match their unique production practices. 
Establishments that do not have handling procedures in place that meet 
the proposed safe harbor requirements, would be required to either 
adhere to the proposed safe harbor handling requirements or develop 
procedures that meet the proposed handling performance standard. FSIS 
is requesting comment on the possible economic impact of these proposed 
handling requirements (see ``Executive Order 12866 and Regulatory 
Flexibility Act,'' below).

Performance Standards for Partially Cooked and Char-Marked Meat Patties 
and Partially Cooked Poultry Breakfast Strips

    Unlike the fully cooked, ready-to-eat products described above, 
partially cooked and char-marked uncured meat patties and partially 
cooked poultry breakfast strips are essentially raw, and require 
adequate cooking prior to consumption. A lethality performance standard 
therefore would not apply to partially cooked and char-marked products, 
since FSIS does not require that these products be ready-to-eat. 
Neither would a handling performance standard apply, since these raw 
products may contain infectious pathogenic microorganisms after 
processing and prior to cooking. FSIS is proposing, however, that 
establishments producing these products meet a stabilization 
performance standard identical to the stabilization standard proposed 
above for fully cooked products.
    During processing, these products are partially cooked and then 
cooled, which creates a model environment for the growth of C. 
perfringens, C. botulinum, and other spore-forming, toxigenic bacteria. 
Cooking by the consumer, retailer, or other end-user may not eliminate 
these bacteria from these products. Therefore, it is important that 
bacterial growth be controlled in these products to the extent possible 
while they remain at the producing establishment. Accordingly, FSIS is 
proposing that in partially cooked and char-marked uncured meat patties 
and partially cooked poultry breakfast strips, establishments prevent 
the germination and multiplication of toxigenic microorganisms such as 
C. botulinum, and allow no more than a 1-decimal log multiplication of 
C. perfringens.
    The current regulations for partially cooked and char-marked 
uncured meat patties and partially cooked poultry breakfast strips 
require, among other things, that these products be quickly chilled 
following partial cooking or char-marking, in order to inhibit the 
growth of vegetative, spore-forming bacteria. Section 318.23, paragraph 
(b)(1)(ii) requires that partially cooked meat patties be cooled to a 
maximum internal temperature of 40  deg.F within 2 hours following 
partial cooking. Section 318.23, paragraph (b)(1)(iii) requires that 
char-marked meat patties be char-marked and then cooled to a maximum 
internal temperature of 40  deg.F within 2 hours. Section 381.150, 
paragraph (a) requires that following partial cooking, partially cooked 
poultry breakfast strips be cooled to 80  deg.F within 1.5 hours and to 
40  deg.F within 5 hours. When applied, these chilling requirements 
prevent the germination and multiplication of toxigenic microorganisms 
such as C. botulinum and allow no more than a 1-decimal log 
multiplication of C. perfringens, that is, they produce partially 
cooked and char-marked products that meet the stabilization performance 
standard presented in this document.
    Therefore, as a result of this proposal, establishments continuing 
to follow the current regulations regarding the chilling of partially 
cooked and char-marked uncured meat patties and partially cooked 
poultry breakfast strips (the proposed safe harbors) would produce 
cooked products that meet the stabilization standard for partially 
cooked products proposed in this document. And, establishments that 
choose to produce these products using procedures other than those 
retained in the proposed safe harbors would be required to meet the 
same rigorous measure of stabilization.
    FSIS requires that partially cooked and char-marked meat patties, 
as well as partially cooked poultry breakfast strips, be labeled with 
cooking directions. It is imperative that consumers fully cook these 
products, as they are essentially raw, and may contain viable 
pathogenic microorganisms. Therefore, FSIS is proposing that these 
labeling requirements remain in the regulations governing partially 
cooked and char-marked meat patties and partially cooked poultry 
breakfast strips.

Miscellaneous

    Section 317.2, paragraph (l) and Sec. 381.125, paragraph (b) of the 
regulations require that safe handling instructions be provided for 
beef products, meat patties, and poultry products not heat processed in 
a manner that conforms to the time and temperature combinations listed 
in Secs. 318.17, 318.23, and 381.150, respectively. This proposal, 
however, would allow ready-to-eat products to be processed by means 
other than the time and temperature requirements currently prescribed 
in these sections, as long as they met the performance standards 
proposed. Therefore, as a result of this proposal, safe handling label 
requirements would not be applicable to all ready-to-eat products 
processed by means other than the currently prescribed time and 
temperature combinations. FSIS proposes to amend 317.2, paragraph (l) 
and Sec. 381.125, paragraph (b), to reflect this change.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be significant for the purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.

[[Page 19571]]

    In accordance with 5 U.S.C. 603, we have performed an Initial 
Regulatory Flexibility Analysis, which is set out below, regarding the 
impact of this rule on small entities. However, we do not currently 
have all the data necessary for a comprehensive analysis of the effects 
of this rule on small entities. Therefore, we are inviting comments 
concerning potential effects. In particular, we are interested in 
determining the number and kind of small entities that may incur 
benefits or costs from implementation of this proposed rule.
    This rule would allow individual establishments to employ 
processing methods other than those currently mandated, as long as 
those methods yield products that meet the performance standards set 
out in this rule. Since the currently mandated methods meet the 
performance standards and would be retained as ``safe harbors,'' 
establishments could choose to continue using their current methods and 
probably incur no new expenses (or savings or income) as a result of 
this rule. Therefore, we anticipate that the rule would have a 
favorable economic impact on all establishments, regardless of size.
    As stated above, FSIS is proposing to amend the current regulations 
in Sec. 381.150 (the proposed safe harbor for certain cooked poultry 
products) by adding the chilling requirements for cooked poultry 
currently contained in FSIS Directive 7110.3. This proposed amendment 
would help to clarify and complete in a single section of the Poultry 
Products Inspection Regulations the proposed safe harbor regulations 
for certain cooked poultry products. Because establishments producing 
cooked poultry products already must meet the chilling requirements set 
forth in FSIS Directive 7110.3, FSIS anticipates that codifying these 
requirements in the regulations would have no economic impact.
    Also, because currently there are no explicit handling regulations 
for cooked poultry products, some establishments may be required to 
develop new procedures in order to meet the proposed handling 
performance standard for cooked products. Establishments already 
following the proposed handling safe harbor requirements would not have 
to change their handling procedures in order to meet the proposed 
handling performance standards. These establishments may wish to take 
advantage of the flexibility afforded by the proposed performance 
standards, however, and develop handling procedures that more closely 
match their unique production practices. Establishments that do not 
have handling procedures in place that meet the proposed safe harbor 
requirements, would be required to either adhere to the proposed safe 
harbor handling requirements or develop procedures that meet the 
proposed handling performance standard.
    FSIS anticipates that any impact on these firms would be minimal, 
because the proposed handling requirements for cooked poultry products 
represent current GMPs accepted and in general use by industry. Data 
necessary for a comprehensive analysis of the effects of these proposed 
handling safe harbors on poultry establishments is not currently 
available to FSIS. Therefore, FSIS invites public comment concerning 
potential economic effects of these proposed requirements.
    When an establishment wants to use a processing method other than 
those contained in the safe harbors, either because it will be more 
efficient or improve its product, we can assume by its decision to 
incur the expense of using that method (only a small part of which 
would be to meet the requirements of the proposed rule) that it expects 
to receive increased revenues in the future from the investment in the 
method. In that sense, the rule could have favorable economic 
consequences for firms that choose to innovate. Also, the increased 
flexibility to innovate allowed by the rule could encourage competition 
and benefit consumers with lower prices or higher quality products.
    It is difficult to quantify the potential benefits of this proposal 
since it is not possible to predict exactly how many establishments 
would develop innovative processes and how these innovations would 
generate revenues or benefits to consumers. There are approximately 
1,000 establishments currently producing the cooked beef products, 
uncured meat patties, and poultry products addressed by this proposal. 
FSIS expects that only about five to ten percent of these 
establishments would choose to develop customized process schedules 
prior to the implementation of HACCP. FSIS anticipates that most, if 
not all, of these establishments would develop alternative process 
schedules for the production of ready-to-eat poultry products.
    Under the current regulations, FSIS requires that ready-to-eat 
poultry products reach specific, minimum internal temperatures before 
being removed from a cooking medium. The products lose water during 
cooking at these temperatures and consequently, establishments must add 
water and other ingredients both to make the products palatable and to 
restore lost yield.
    Therefore, FSIS anticipates that most establishments initially 
taking advantage of the proposed performance standards would develop 
customized process schedules for ready-to-eat poultry products and 
would benefit from some cost savings. FSIS expects that most 
establishments producing roast beef and meat patty products would not 
develop customized process schedules prior to implementing HACCP, as it 
would be less duplicative and more cost-effective to use the proposed 
performance standards to develop critical limits within HACCP plans.
    Finally, there is the potential for an increase in the efficiency 
of the nation's economy in general because the proposed rule encourages 
businesses to consider a more efficient use of resources. Also, the 
possibility of reduced prices of meat or poultry products are economic 
factors that could produce a more efficient use of resources in the 
economy as a whole. These effects would be small for individual firms 
and consumers, but could be substantial in the aggregate.

Executive Order 12778

    This proposed rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the Federal Meat Inspection Act and the Poultry Products Inspection Act 
(PPIA) from imposing any marking or packaging requirements on federally 
inspected meat and poultry products that are in addition to, or 
different than, those imposed under the FMIA or the 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 and 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 proposed 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 
proposed rule. However, the administrative procedures specified in 9 
CFR Secs. 306.5 and 381.35 must be exhausted prior to any judicial 
challenge of the application of the provisions of this proposed rule, 
if the challenge involves any decision of an FSIS employee relating to 
inspection

[[Page 19572]]

services provided under the FMIA or the PPIA.

Paperwork Requirements

    Title: Performance Standards for Certain Meat and Poultry Products.
    Type of Collection: New.
    Abstract: FSIS has reviewed the paperwork and recordkeeping 
requirements in this proposed rule in accordance with the Paperwork 
Reduction Act. Under this proposed rule, establishments choosing to 
meet performance standards for certain cooked beef products, uncured 
meat patties, and certain fully and partially cooked poultry products 
either by means other than those described in the current regulations 
or under the HACCP requirements, would be required to develop a written 
process schedule and maintain a copy of the process schedule on file.
    The process schedule would detail all the specific, sequential 
operations that compose the process used by each establishment to 
produce its specific products. The process schedule would also contain 
the related control, monitoring, validation, and corrective action 
activities associated with the procedure. Further, this process 
schedule must have been evaluated and approved for safety, efficacy, 
and equivalency by a process authority.
    FSIS inspectors would initially, and periodically as required, 
review the process schedule and any other relevant records to ensure 
that the product is processed according to the procedures on file. FSIS 
personnel would not evaluate the process authority-approved procedures 
for efficacy.
    Again, developing and implementing processing procedures different 
from those in the current regulations would be optional. FSIS assumes 
that an establishment would develop and implement such processing 
procedures only if the resulting economic advantages outweighed the 
accompanying costs, including the paperwork burden.
    FSIS is proposing to amend the current regulations in Sec. 381.150 
(the proposed safe harbor for certain cooked poultry products) by 
adding the chilling requirements for cooked poultry currently contained 
in FSIS Directive 7110.3. The paperwork burden hours for FSIS Directive 
7110.3 are approved under OMB control number 0583-0089.
    Finally, because currently there are no explicit handling 
regulations for cooked poultry products, some establishments may be 
required to develop new procedures in order to meet the proposed 
handling performance standard for cooked products. FSIS has accounted 
for the paperwork and recordkeeping burden hours resulting from the 
proposed handling requirements in the estimate of burden for process 
schedules below.
    Estimate of Burden: FSIS estimates that the process schedule would 
take an average of 2 days (16 hours) to develop and 5 minutes to file. 
The written description of the establishment validation procedures, 
whether conducted for new or altered process schedules, would take no 
more than 1 day (8 hours) to complete and 5 minutes to file.
    Respondents: Meat and poultry product establishments.
    Estimated Number of Respondents: 1,000 (this number represents the 
total number of establishments that could change their operations).
    Estimated Number of Responses per Respondent: 1.
    Estimated Total Annual Burden on Respondents: 24,166 hours.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, South Agriculture Building, Room 3812, Washington, DC 
20250.
    Comments are invited on: (a) whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information will have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology. Comments may be sent to Lee 
Puricelli, Paperwork Specialist, see address above, and Desk Officer 
for Agriculture, Office of Information and Regulatory Affairs, Office 
of Management and Budget, Washington, DC 20253.
    Comments are requested by July 1, 1996. To be most effective, 
comments should be sent to OMB within 30 days of the publication date 
of this proposed rule.

List of Subjects

9 CFR Part 301

    Meat inspection.

9 CFR Part 317

    Food labeling.

9 CFR Part 318

    Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 320

    Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 381

    Poultry and poultry products inspection, Reporting and 
recordkeeping requirements.

    Accordingly, title 9, chapter III, of the Code of Federal 
Regulations would be amended as follows:

PART 301--DEFINITIONS

    1. The authority citation for part 301 would be revised to read as 
follows:

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

    2. Section 301.2 would be amended by removing the paragraph 
designations (a) through (yyy) and adding, in alphabetical order, new 
definitions for ``Process Schedule'' and ``Process authority'' to read 
as follows:


Sec. 301.2  Definitions.

* * * * *
    Process authority. A person or organization with expert knowledge 
in meat production process control and relevant regulations. This 
definition does not apply to subpart G of this part.
    Process schedule. A process schedule is a written description of 
processing procedures, consisting of any number of specific, sequential 
operations directly under control of the establishment employed in the 
manufacture of a specific product, including the control, monitoring, 
validation, and corrective action activities associated with 
production. This definition does not apply to subpart G of this part.
* * * * *

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

    3. The authority citation for part 317 would continue to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    4. In Sec. 317.2, paragraph (l) would be revised to read as 
follows:


Sec. 317.2  Labels: definition; required features.

* * * * *
    (l) Safe handling instructions shall be provided for: All meat and 
meat products of cattle, swine, sheep, goat, horse, or other equine not 
heat processed in a manner that conforms to the time and temperature 
combinations in the Table for Time/Temperature

[[Page 19573]]

Combination For Cooked Beef, Roast Beef, and Cooked Corned Beef in 
Sec. 318.17 of this chapter, or that have not undergone other 
processing that would render them ready-to-eat; and all comminuted meat 
patties not processed in accordance with the standard for fully cooked 
patties in Sec. 318.23 of this chapter; except as exempted under 
paragraph (l)(4) of this section.
* * * * *

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

    5. The authority citation for part 318 would be revised 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.

    6. Section 318.17 would be revised to read as follows:


Sec. 318.17  Requirements for the production of cooked beef, roast 
beef, and cooked corned beef products.

    (a) Cooked beef, roast beef, and cooked corned beef products must 
be produced using processes ensuring that the products meet the 
following performance standards:
    (1) Lethality. A 7-decimal log reduction of Salmonella must be 
achieved within the product. The lethality process must include a 
cooking step.
    (2) Stabilization. There can be no germination and multiplication 
of toxigenic microorganisms such as Clostridium botulinum, and no more 
than a 1-decimal log multiplication of Clostridium perfringens within 
the product.
    (3) Handling. There can be no recontamination of product by 
infectious pathogens at any time from processing through the final 
packaging.
    (b) For each product produced using a process other than the 
process provided as an example in paragraph (e) of this section or a 
process conducted in accordance with the Hazard Analysis and Critical 
Control Point (HACCP) system requirements set, an establishment must 
develop and have on file, available to FSIS, a process schedule, as 
defined in Sec. 301.2 of this chapter. Each process schedule must be 
approved, in writing, by a process authority for safety and efficacy in 
meeting the performance standards established for the product in 
question. A process authority must have access to an establishment in 
order to evaluate and approve the safety and efficacy of each process 
schedule.
    (c) Establishments must validate the process schedule by producing 
and testing product against applicable performance standards, in 
accordance with a statistically valid sampling program designed by the 
process authority. No product can released for commercial use until 
samples are tested and found to meet the applicable performance 
standards. After a process authority has approved an establishment's 
process schedule and before the production of lots to be held and 
tested, the establishment must notify FSIS that it is implementing a 
process other than that described in paragraph (e) of this section.
    (d) Should an establishment wish to alter any procedures contained 
in an approved process schedule, a process authority must evaluate and 
approve, in writing, the proposed alterations prior to their 
implementation. The process authority can approve only alterations that 
result in the continued production of product meeting applicable 
performance standards. Prior to the commercial release of any product 
produced by approved, altered procedures, the establishment must 
validate the altered process schedule by sampling and testing product 
in accordance with a statistically valid sampling program designed by 
the process authority; the tested product must meet applicable 
performance standards.
    (e) Example. An establishment may produce cooked beef, roast beef, 
and cooked corned beef products using the processes described in the 
following example, which meets the performance standards listed in 
paragraph (a) of this section:
    (1) Cooked beef and roast beef, including sectioned and formed 
roasts and chunked and formed roasts, and cooked corned beef shall be 
prepared by one of the time and temperature combinations in the 
following table. The stated temperature is the minimum which shall be 
produced and maintained in all parts of each piece of meat for at least 
the stated time:

 Table for Time/Temperature Combination for Cooked Beef, Roast Beef, and
                           Cooked Corned Beef                           
------------------------------------------------------------------------
                Minimum internal temperature                   Minimum  
------------------------------------------------------------  processing
                                                               time in  
                                                               minutes  
                                                   Degrees      after   
               Degrees Fahrenheit                Centigrade    minimum  
                                                             temperature
                                                              is reached
------------------------------------------------------------------------
130............................................        54.4         121 
131............................................        55.0          97 
132............................................        55.6          77 
133............................................        56.1          62 
134............................................        56.7          47 
135............................................        57.2          37 
136............................................        57.8          32 
137............................................        58.4          24 
138............................................        58.9          19 
139............................................        59.5          15 
140............................................        60.0          12 
141............................................        60.6          10 
142............................................        61.1           8 
143............................................        61.7           6 
144............................................        62.2           5 
145............................................        62.8       (\1\) 
------------------------------------------------------------------------
\1\ Instantly.                                                          

    (2) Cooked beef, including sectioned and formed roasts and chunked 
and formed roasts, and cooked corned beef shall be moist cooked 
throughout the process or, in the case of roast beef or corned beef to 
be roasted, cooked as provided in paragraph (e)(3) of this section. The 
moist cooking may be accomplished by placing the meat in a sealed, 
moisture impermeable bag, removing the excess air, and cooking, 
completely immersing the meat, unbagged, in water throughout the entire 
cooking process, or using a sealed oven or steam injection to raise the 
relative humidity above 90 percent throughout the cooking process.
    (3) Roast beef or corned beef to be roasted shall be cooked by one 
of the following methods:
    (i) Heating roasts of 10 pounds or more in an oven maintained at 
250 degrees F. (121 degrees C.) or higher throughout the process;
    (ii) Heating roasts of any size to a minimum internal temperature 
of 145 degrees F. (62.8 degrees C.) in an oven maintained at any 
temperature if the relative humidity of the oven is maintained either 
by continuously introducing steam for 50 percent of the cooking time or 
by use of a sealed oven for over 50 percent of the cooking time, or if 
the relative humidity of the oven is maintained at 90 percent or above 
for at least 25 percent of the total cooking time, but in no case less 
than 1 hour; or
    (iii) Heating roasts of any size in an oven maintained at any 
temperature that will satisfy the internal temperature and time 
requirements of paragraph (e)(1) of this section if the relative 
humidity of

[[Page 19574]]

the oven is maintained at 90 percent or above for at least 25 percent 
of the total cooking time, but in no case less than 1 hour.
    (iv) The relative humidity may be achieved by use of steam 
injection or by sealed ovens capable of producing and maintaining the 
required relative humidity.
    (4)(i) Except as provided in paragraph (e)(4)(ii) of this section, 
establishments producing cooked beef, roast beef, or cooked corned beef 
shall have sufficient monitoring equipment, including recording 
devices, to assure that the time (within 1 minute), the temperature 
(within 1 degree F.), and relative humidity (within 5 percent) limits 
of these processes are being met. Data from the recording devices shall 
be made available to a program employee upon request.
    (ii) In lieu of recording devices, establishments may propose in 
the written procedures prescribed in paragraph (e)(6) of this section, 
an alternative means of providing inspection personnel with evidence 
that finished product has been prepared in compliance with the humidity 
requirements of paragraphs (e)(2) and (e)(3) of this section, and the 
145 degrees F. (62.8 degrees C.) temperature requirements of paragraph 
(e)(1) of this section.
    (5) Each package of finished product shall be plainly and 
permanently marked on the immediate container with the date of 
production either in code or with the calendar date.
    (6) In order to assure that cooked beef, roast beef, and cooked 
corned beef are handled, processed, and stored under sanitary 
conditions, the establishment shall submit a set of written procedures 
through the inspector-in-charge for approval by the Regional Director. 
The written procedures shall include the following information:
    (i) The temperature to which raw frozen product is thawed and the 
time required.
    (ii) The lot identification procedure for lots of product during 
processing.
    (iii) The storage time and temperature combinations which the 
establishment intends to use before cooking, the cooking time and 
temperature the establishment intends to use, and the time, if any, the 
establishment intends to wait after cooking and before cooling.
    (iv) If a code, instead of the calendar date, is used on the 
immediate container of the finished product, its meaning shall also be 
included.
    (v) Any other critical control points in the procedures which could 
affect the safety of the product.
    (vi) In lieu of recording devices, the alternate means permitted by 
paragraph (e)(4)(ii) of this section for providing evidence to 
inspection personnel that the finished product will be prepared in 
compliance with temperature or humidity requirements.
    (vii) Any other alternate procedure used that is permitted in this 
section.
    (7) The establishment shall maintain records and reports which 
document the time, temperature, and humidity at which any cooked beef, 
roast beef, or cooked corned beef is cooked and cooled at the 
establishment. Such records shall be kept by the establishment for 6 
months or for such further period as the Administrator may require for 
purposes of any investigation or litigation under the Act, by written 
notice to the person required to keep such records. Such records shall 
be made available to the inspector or any duly authorized 
representative of the Secretary upon request.
    (8) The handling and processing of cooked beef, roast beef, and 
cooked corned beef before, during, and after cooking shall be such as 
to prevent the finished product from being adulterated. As a minimum, 
they shall be controlled as follows:
    (i) The establishment shall notify the inspector-in-charge which 
processing procedure will be used on each lot, including time and 
temperature.
    (ii) In order to assure uniform heat penetration and consequent 
adequate cooking of each piece of beef, individual pieces of raw 
product in any one lot shall either not vary in weight by more than 2 
pounds or not vary in thickness by more than 2 inches at the thickest 
part. Alternate methods of assuring uniform heat penetration may be 
submitted in writing for approval to the Regional Director.
    (iii) A water-based solution that is used for injecting or 
immersing the meat shall be refrigerated to 50 degrees F. (10 degrees 
C.) or lower from the time it contacts the meat, and shall be filtered 
each time it is recirculated or reused.
    (iv) A nonmeat ingredient, including the water-based solution in 
paragraph (e)(8)(iii) of this section, which has contacted meat shall 
be discarded at the end of that day's production unless it is in 
continuous contact with one batch of product.
    (v) Product prepared for cooking shall be entered into the cooking 
cycle within 2 hours of completion of precooking preparation, or be 
placed immediately in a cooler at a temperature of 40 degrees F. (4.4 
degrees C.) or lower.
    (vi) The time and temperature requirements shall be met before any 
product in the lot is removed from the cooking units. Unless otherwise 
specified in the written procedures approved in accordance with 
paragraph (e)(6) of this section, the heat source shall not be shut off 
until these requirements are met.
    (vii) Other than incidental contact caused by water currents during 
immersion cooking or cooling, product shall be placed so that it does 
not touch or overlap other products. This provision does not apply to 
product that is stirred or agitated to assure uniform heat transfer.
    (viii) Temperature sensing devices shall be so placed that they 
monitor product in the coldest part of the cooking unit; and when an 
oven temperature is required by paragraph (e)(3) of this section, the 
oven temperature shall also be monitored in the coldest part of the 
cooking unit.
    (ix) If a humidity sensing device is required in an oven, it shall 
be placed so that it measures humidity in either the oven chamber or at 
the exit vent.
    (x) Chilling shall begin within 90 minutes after the cooking cycle 
is completed.
    (A) All product shall be chilled from 120 degrees F. (48.8 degrees 
C.) to 55 degrees F. (12.7 degrees C.) in no more than 6 hours.
    (B) Chilling shall continue and the product shall not be packed for 
shipment until it has reached 40 degrees F. (4.4 degrees C.).
    (xi) Any establishment that has experienced a cooking process 
deviation during preparation of product may either reprocess the 
product completely, continue the heating to 145 degrees F. (62.8 
degrees C.), or contact the Regional Director for a review of the 
process schedule for adequacy and, if needed, for a cooking schedule to 
finish that one batch of product.
    (xii) An establishment that has experienced a cooling deviation 
after the product has been cooked shall contact the Regional Director 
to determine the disposition of that retained product.
    (9) Cooked beef, roast beef, and cooked corned beef shall be so 
handled as to assure that the product is not recontaminated by direct 
contact with raw product. To prevent direct contamination of the cooked 
product, establishments shall:
    (i) Physically separate areas where raw product is handled from 
areas where exposed cooked product is handled, using a solid impervious 
floor to ceiling wall;
    (ii) Handle raw and exposed cooked product at different times, with 
a cleaning of the entire area after the raw material handling is 
completed and

[[Page 19575]]

prior to the handling of cooked product in that area; or
    (iii) Submit a written procedure for approval through the 
inspector-in-charge to the Circuit Supervisor detailing the steps to be 
taken which would avoid recontamination of cooked product by raw 
product during processing.
    (10) To prevent indirect contamination of cooked product:
    (i) Any work surface, machine, or tool which contacts raw product 
shall be thoroughly cleaned and sanitized with a solution germicidally 
equivalent to 50 ppm chlorine before it contacts cooked product;
    (ii) Employees shall wash their hands and sanitize them with a 
solution germicidally equivalent to 50 ppm chlorine whenever they enter 
the heat processed product area or before preparing to handle cooked 
product, and as frequently as necessary during operations to avoid 
product contamination; and
    (iii) Outer garments, including aprons, smocks, and gloves, shall 
be especially identified as restricted for use in cooked product areas 
only, changed at least daily, and hung in a designated location when 
the employee leaves the area.
    (11) Cooked product shall not be stored in the same room as raw 
product unless it is first packaged in a sealed, water-tight container 
or is otherwise protected by a covering that has been approved, upon 
written request, by the Circuit Supervisor.
    7. Section 318.23 would be revised to read as follows:


Sec. 318.23  Requirements for the production of uncured meat patties.

    (a) Fully cooked, uncured meat patties must be produced using 
processes ensuring that the products meet the following performance 
standards:
    (1) Lethality. A 5-decimal log reduction of Salmonella must be 
achieved within the product. The lethality process must include a 
cooking step.
    (2) Stabilization. There can be no germination and multiplication 
of toxigenic microorganisms such as Clostridium botulinum, and no more 
than a 1-decimal log multiplication of Clostridium perfringens within 
the product.
    (3) Handling. There can be no recontamination of product by 
infectious pathogens at any time from processing through the final 
packaging.
    (b) Partially cooked and char-marked meat patties must be produced 
using processes ensuring that the products meet the performance 
standard listed in paragraph (a)(2) of this section.
    (1) Partially cooked patties must bear the labeling statement 
``Partially cooked: For Safety Cook Until Well Done (Internal Meat 
Temperature 160 degrees F.)''. The labeling statement must be adjacent 
to the product name, at least one-half the size of the largest letter 
in the product name, and prominently placed with such conspicuousness 
(as compared with other words, statements, designs or devices in the 
labeling) as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.
    (2) Char-marked patties must bear the labeling statement 
``Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal 
Meat Temperature 160 degrees F.)''. The labeling statement shall be 
adjacent to the product name, at least one-half the size of the largest 
letter in the product name, and prominently placed with such 
conspicuousness (as compared with other words, statements, designs or 
devices in the labeling) as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (c) For each product produced using a process other than the 
process described in paragraph (f) of this section or a process 
conducted in accordance with the Hazard Analysis and Critical Control 
Point (HACCP) system requirements, an establishment must develop and 
have on file, available to FSIS, a process schedule, as defined in 
Sec. 301.2 of this chapter. Each process schedule must be approved, in 
writing, by a process authority for safety and efficacy in meeting the 
performance standards established for the product in question. A 
process authority must have access to an establishment in order to 
evaluate and approve the safety and efficacy of each process schedule.
    (d) Establishments must validate the process schedule by producing 
and testing product against applicable performance standards, in 
accordance with a statistically valid sampling program designed by the 
process authority. No product can released for commercial use until 
samples are tested and found to meet the applicable performance 
standards. After a process authority has approved an establishment's 
process schedule and before the production of lots to be held and 
tested, the establishment must notify FSIS that it is implementing a 
process other than that described in paragraph (f) of this section.
    (e) Should an establishment wish to alter any procedures contained 
in an approved process schedule, a process authority must evaluate and 
approve, in writing, the proposed alterations prior to their 
implementation. The process authority can approve only alterations that 
result in the continued production of product meeting applicable 
performance standards. Prior to the commercial release of any product 
produced by approved, altered procedures, the establishment must 
validate the altered process schedule by sampling and testing product 
in accordance with a statistically valid sampling program designed by 
the process authority; the tested product must meet applicable 
performance standards.
    (f) Example. An establishment may produce uncured meat patties 
using the processes described in this example, which meet the 
applicable performance standards listed in paragraph (a) of this 
section.
    (1) Definitions. For purposes of Sec. 318.23, the following 
definitions shall apply:
    (i) Comminuted. A processing term describing the reduction in size 
of pieces of meat, including chopping, flaking, grinding, or mincing, 
but not including chunking or sectioning.
    (ii) Heat-processed. Treatment by a heat source, including, but not 
limited to, frying, broiling, baking, or roasting, which results in a 
fully-cooked, partially-cooked, or char-marked product.
    (iii) Patty. A shaped and formed, comminuted, flattened cake of 
meat food product.
    (2) Processing procedures for heat-processed patties. Fully-cooked, 
partially-cooked, or char-marked patties shall be processed as follows:
    (i) Heat processing. (A) Official establishments which manufacture 
fully-cooked patties shall utilize the following heat-processing 
procedures:

Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked
                                 Patties                                
------------------------------------------------------------------------
  Minimum internal temperature at the center of each    Minimum holding 
                        patty                              time after   
------------------------------------------------------      maximum     
                                                         temperature is 
                                                            reached     
        Degrees Fahrenheit         Degrees Centigrade ------------------
                                                        Minutes  Seconds
------------------------------------------------------------------------
151..............................  66.1..............      0.68       41
152..............................  66.7..............       .54       32
153..............................  67.2..............       .43       26
154..............................  67.8..............       .34       20
155..............................  68.3..............       .27       16
156..............................  68.9..............       .22       13
157 (and up).....................  69.4 (and up).....       .17       10
------------------------------------------------------------------------

    (B) Official establishments which manufacture partially-cooked 
patties

[[Page 19576]]

shall raise the internal temperature at the center of each patty to a 
minimum internal temperature of 140 degrees F. and then cool it to a 
maximum internal temperature of 40 degrees F. within 2 hours.
    (C) Official establishments which manufacture char-marked patties 
(if marked by a heat source) may raise the temperature at the center of 
each patty, but not above 70 degrees F., when the char-marks are 
applied to the patty. The process of char-marking the patty and cooling 
the patty to a maximum internal temperature of 40 degrees F. shall be 
completed within 2 hours or less.
    (D) The official establishment shall measure the holding time and 
temperature of at least one heat-processed patty from each production 
line each hour of production to assure control of the heat process. The 
temperature measuring device shall be accurate within 1 degrees F.
    (ii) Cooling. (A) Fully-cooked patties shall be cooled to an 
internal temperature of 40 degrees F. or below within 2 hours after 
heat-processing.
    (B) Cooling requirements for partially-cooked and char-marked 
patties are combined with those for heat-processing and are contained 
in paragraph (f)(2)(i) (B) and (C) of this section.
    (C) The internal temperature measuring device shall be accurate 
within 1 degrees F.
    (iii) Cooking instruction label requirement. (A) Partially-cooked 
patties shall bear the labeling statement ``Partially-cooked: For 
Safety Cook Until Well Done (Internal Meat Temperature 160 degrees 
F.)''. The labeling statement shall be adjacent to the product name, at 
least one-half the size of the largest letter in the product name, and 
prominently placed with such conspicuousness (as compared with other 
words, statements, designs or devices in the labeling) as to render it 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use.
    (B) Char-marked patties shall bear the labeling statement 
``Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal 
Meat Temperature 160 degrees F.)''. The labeling statement shall be 
adjacent to the product name, at least one-half the size of the largest 
letter in the product name, and prominently placed with such 
conspicuousness (as compared with other words, statements, designs or 
devices in the labeling) as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (iv) Sanitary handling and storage practices. Fully-cooked patties 
shall be handled in accordance with the following provisions so as to 
assure that the patties are not recontaminated.
    (A) To prevent direct contamination of fully-cooked patties, 
official establishments shall:
    (1) Physically separate areas where unpackaged, fully-cooked 
patties are handled from areas where less-than-fully-cooked products 
are handled using a solid impervious floor to ceiling wall;
    (2) Handle unpackaged, fully-cooked patties and less-than-fully-
cooked product at different times, and cleaning the entire area after 
handling other products before handling unpackaged, fully-cooked 
patties; or
    (3) Submit a written procedure through the inspector-in-charge to 
the Regional Director detailing the steps to be taken which would avoid 
recontamination of fully-cooked patties by less-than-fully-cooked 
product during processing.
    (B) To prevent indirect contamination of fully-cooked patties:
    (1) Any work surface, machine, or tool which contacts other product 
shall be cleaned and sanitized before it contacts unpackaged fully-
cooked patties. The sanitizer shall be germicidally equivalent to 50 
ppm chlorine.
    (2) Employees shall wash their hands with soap and water and 
sanitize their hands whenever they enter the fully-cooked patty area or 
before handling unpackaged, fully-cooked patties. They must also wash 
and sanitize their hands whenever they become contaminated during 
operations to avoid contamination of fully-cooked patties. The 
sanitizer shall be germicidally equivalent to 50 ppm chlorine.
    (3) All employee outer garments, including aprons, smocks, and 
gloves shall be identified as restricted for use in the fully-cooked 
area only. The employee shall change garments at least daily. The 
garments shall be hung in a designated location before the employee 
leaves the area.
    (C) Fully-cooked patties stored in the same room with other 
product, shall first be packaged or covered to prevent microbial 
contamination.
    (D) Fully-cooked, partially-cooked, and char-marked patties shall 
be stored at a chamber temperature of 40 degrees F. or below.
    (3) Requirements for Handling Heating or Cooling Deviations.
    (i) If for any reason a heating or cooling deviation has occurred, 
the official establishment shall investigate and identify the cause; 
take steps to assure that the deviation will not recur; and place on 
file in the official establishment, available to any duly authorized 
representative of the Secretary, a report of the investigation, the 
cause of the deviation, and the steps taken to prevent recurrence; and
    (ii) In addition, in the case of a heating deviation, the official 
establishment may reprocess the affected product, by a method in 
paragraph (f)(2)(i)(A) in this section; use the affected product as an 
ingredient in another product processed to one of the temperature and 
time combinations in paragraph (f)(2)(i)(A) in this section, provided 
this does not violate the final product's standard of composition, 
upset the order of predominance of ingredients, or perceptibly affect 
the normal product characteristics; or relabel the affected product as 
a partially-cooked patty product, if it meets the partially-cooked 
requirements in paragraph (f)(2)(i)(B) of this section.
    (iii) In addition, in the case of a cooling deviation, contact the 
Regional Director to determine the disposition of the product.

PART 320--RECORDS, REGISTRATION, AND REPORTS

    8. The authority citation for part 320 would be revised to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


Sec. 320.1  [Amended]

    9. In Sec. 320.1, paragraph (b)(4), the phrase ``Sec. 318.17(d)'' 
would be removed and the phrase ``Sec. 318.17(e)(4)'' would be added in 
its place.


Sec. 320.4  [Amended]

    10. In Sec. 320.4, the first sentence would be amended by adding 
the phrase ``process schedules,'' immediately before the phrase 
``facilities and inventory''

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    11. The authority citation for part 381 would be revised to read as 
follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 
2.53.

    12. Section 381.1 would be amended by adding new paragraphs (b)(63) 
and (b)(64) to read as follows:


Sec. 381.1  Definitions.

* * * * *
    (b) * * *
    (63) Process schedule. A process schedule is a written description 
of processing procedures, consisting of any number of specific, 
distinct, and ordered operations directly under control of the 
establishment employed in the manufacture of a specific product, 
including the control, monitoring,

[[Page 19577]]

validation, and corrective action activities associated with 
production.
    (64) Process authority. A person or organization with expert 
knowledge in poultry production process control and relevant 
regulations.
* * * * *


Sec. 381.125  [Amended]

    13. In Sec. 381.125, the introductory text of paragraph (b) would 
be amended by removing the phrase ``Sec. 381.150(b)'' and by adding the 
phrase ``Sec. 381.150(f)(2)(i)'' in its place; and by removing the word 
``further''.
    14. Section 381.150 would be revised to read as follows:


Sec. 381.150  Requirements for the production of cooked poultry 
products and partially cooked poultry breakfast strips.

    (a) Cooked poultry products must be produced using processes 
ensuring that the products meet the following performance standards:
    (1) Lethality. A 7-decimal log reduction of Salmonella must be 
achieved within the product. The lethality process must include a 
cooking step.
    (2) Stabilization. There can be no germination and multiplication 
of toxigenic microorganisms such as Clostridium botulinum, and no more 
than a 1-decimal log multiplication of Clostridium perfringens within 
the product.
    (3) Handling. There can be no recontamination of product by 
infectious pathogens at any time from processing through the final 
packaging.
    (b) Partially cooked poultry breakfast strips must be produced 
using processes ensuring that the products meet the performance 
standard listed in paragraph (a)(2) of this section. Labeling for these 
products must comply with section 381.125. In addition, the statement 
``Partially Cooked: For Safety, Cook Until Well Done'' must appear on 
the principal display panel in letters no smaller than \1/2\ the size 
of the largest letter in the product name. Detailed cooking 
instructions shall be provided on the immediate container of the 
products.
    (c) For each product produced using a process other than the 
process described in paragraph (f) of this section or a process 
conducted in accordance with the Hazard Analysis and Critical Control 
Point (HACCP) system requirements, an establishment must develop and 
have on file, available to FSIS, a process schedule, as defined in 
Sec. 381.1. Each process schedule must be approved, in writing, by a 
process authority for safety and efficacy in meeting the performance 
standards established for the product in question. A process authority 
must have access to an establishment in order to evaluate and approve 
the safety and efficacy of each process schedule.
    (d) Establishments must validate the process schedule by producing 
and testing product against applicable performance standards, in 
accordance with a statistically valid sampling program designed by the 
process authority. No product can be released for commercial use until 
samples are tested and found to meet the applicable performance 
standards. After a process authority has approved an establishment's 
process schedule and before the production of lots to be held and 
tested, the establishment must notify FSIS that it is implementing a 
process other than that described in paragraph (f) of this section.
    (e) Should an establishment wish to alter any procedures contained 
in an approved process schedule, a process authority must evaluate and 
approve, in writing, the proposed alterations prior to their 
implementation. The process authority can approve only alterations that 
result in the continued production of product meeting applicable 
performance standards. Prior to the commercial release of any product 
produced by approved, altered procedures, the establishment must 
validate the altered process schedule by sampling and testing product 
in accordance with a statistically valid sampling program designed by 
the process authority; the tested product must meet applicable 
performance standards.
    (f) Example. An establishment may produce partially cooked poultry 
breakfast strips and cooked poultry products using the processes 
described in the following example, which meet the applicable 
performance standards listed in paragraph (a) of this section.
    (1) Poultry breakfast strips are cured and smoked products which 
require special handling during distribution and additional cooking 
before consumption. These products shall be heated to an internal 
temperature of 140 degrees F. After heating in the establishment, these 
products must be cooled to 80 degrees F. within 1.5 hours and to 40 
degrees F. with 5 hours. Labeling for these products shall comply with 
Sec. 381.125. In addition, the statement ``Partially Cooked: For 
Safety, Cook Until Well Done'' shall appear on the principal display 
panel in letters no smaller than \1/2\ the size of the largest letter 
in the product name. Detailed cooking instructions shall be provided on 
the immediate container of the products.
    (2) Except for product produced in accordance with paragraph (f)(1) 
of this section, poultry rolls and other poultry products produced in 
accordance with this example shall meet the following requirements:
    (i) Heat processing. Poultry rolls and other poultry products that 
are heat processed in any manner shall reach an internal temperature of 
at least 160 degrees F. prior to being removed from the cooking medium, 
except that cured and smoked poultry rolls and other cured and smoked 
poultry products shall reach an internal temperature of at least 155 
degrees F. prior to being removed from the cooking medium. 
Notwithstanding the other provisions of this section, product to which 
heat will be applied incidental to a subsequent processing procedure 
may be removed from the media for such processing provided it is 
immediately fully cooked to the required 160 degrees F. internal 
temperature.
    (ii) Cooling. After heating in the establishment, these products 
must be cooled to 80 degrees F. within 1.5 hours and to 40 degrees F. 
with 5 hours.
    (iii) Handling. The product must be so handled as to assure that 
the cooked product is not recontaminated. To prevent direct 
contamination of the cooked product, establishments shall:
    (A) Physically separate areas where raw product is handled from 
areas where exposed cooked product is handled, using a solid impervious 
floor to ceiling wall.
    (1) Handle raw and exposed cooked product at different times, with 
a cleaning of the entire area after the raw material handling is 
completed and prior to the handling of cooked product in that area; or
    (2) Submit a written procedure for approval through the inspector-
in-charge to the Circuit Supervisor detailing the steps to be taken 
which would avoid recontamination of cooked product by raw product 
during processing.
    (B) To prevent indirect contamination of cooked product:
    (1) Any work surface, machine, or tool which contacts raw product 
shall be thoroughly cleaned and sanitized with a solution germicidally 
equivalent to 50 ppm chlorine before it contacts cooked product;
    (2) Employees shall wash their hands and sanitize them with a 
solution germicidally equivalent to 50 ppm chlorine whenever they enter 
the heat processed product area or before preparing to handle cooked 
product, and as frequently as necessary during operations to avoid 
product contamination; and

[[Page 19578]]

    (3) Outer garments, including aprons, smocks, and gloves, shall be 
especially identified as restricted for use in cooked product areas 
only, changed at least daily, and hung in a designated location when 
the employee leaves the area.
    (C) Cooked product shall not be stored in the same room as raw 
product unless it is first packaged in a sealed, water-tight container 
or is otherwise protected by a covering that has been approved, upon 
written request, by the Circuit Supervisor.

    Done in Washington, DC: April 29, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-10796 Filed 5-01-96; 8:45 am]
BILLING CODE 3410-DM-P