[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Rules and Regulations]
[Pages 732-749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32]



[[Page 732]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

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

[Docket No. 95-033F]


Performance Standards for the Production of Certain Meat and 
Poultry Products

AGENCY: Food Safety and Inspection Service, Agriculture.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat and poultry products inspection regulations by converting 
into performance standards the regulations governing the production of 
cooked beef, roast beef, and cooked corned beef products, fully and 
partially cooked meat patties, and certain fully and partially cooked 
poultry products. Unlike the previous requirements for these products, 
which mandated step-by-step processing measures, the new performance 
standards spell out the objective level of food safety performance that 
establishments must meet, but allow establishments to develop and 
implement processing procedures customized to the nature and volume of 
their production. Establishments that do not wish to change their 
processing practices may continue following the previous requirements 
for these products, which will be disseminated as ``safe harbors'' in 
Agency guidance materials.
    Establishments that have not yet developed and implemented a HACCP 
(Hazard Analysis and Critical Control Point) plan are required to 
develop and maintain on file a documented process schedule that has 
been approved by a process authority for safety and efficacy. The 
process schedule must include control, monitoring, verification, 
validation, and corrective action activities to be performed by the 
establishment during production. Establishments operating under HACCP 
are not required to develop a processing schedule. FSIS expects such 
establishments will develop and implement HACCP plans incorporating 
critical limits that achieve the new performance standards.
    FSIS is not making final the lethality performance standards 
proposed for ready-to-eat, uncured meat patties. Instead, FSIS will be 
proposing revised lethality performance standards for this product in a 
future, separate rulemaking.

EFFECTIVE DATES: March 8, 1999.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director, 
Regulation Development and Analysis Division, Office of Policy, Program 
Development, and Evaluation, Food Safety and Inspection Service, U.S. 
Department of Agriculture (202) 720-5627.

SUPPLEMENTARY INFORMATION:

Background

    On May 2, 1996, FSIS published in the Federal Register (61 FR 
19564-19578) a proposal to convert into performance standards the 
regulations governing the production of 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. FSIS also proposed to maintain in the regulations the then 
current processing requirements as examples of how an establishment 
might comply with the proposed performance standards (``safe 
harbors''). Establishments wishing to continue current manufacturing 
practices could follow these safe harbor examples and meet the proposed 
performance standards.
    FSIS anticipated that establishments operating under HACCP and 
using processing methods other than those described in the safe harbors 
would incorporate into their HACCP plans CCP's and critical limits that 
would achieve the performance standards. Of course, such establishments 
would be required to meet all of the applicable HACCP requirements, 
such as plan validation, as well as the performance standards. 
Importantly in such cases, validation would ensure not only that a 
HACCP plan was functioning as intended, but also that performance 
standards were being met.
    FSIS proposed to require establishments choosing to develop and use 
procedures different from those provided in the safe-harbors, but not 
yet operating under HACCP, to develop and maintain on file a process 
schedule approved by a process authority for safety and efficacy. 
Similar to a HACCP plan, the process schedule would include control, 
monitoring procedures, verification, validation, and corrective action 
activities to be performed by the establishment. This requirement would 
sunset as establishments developed and implemented HACCP systems.

Ready-to-Eat Products

    FSIS proposed to require that certain ready-to-eat products 
(cooked/roast beef products, fully cooked, uncured meat patties, and 
certain fully cooked poultry products) meet three performance 
standards: lethality, stabilization, and handling. FSIS determined that 
ready-to-eat, cooked products meeting these three standards would 
contain no viable pathogenic microorganisms of concern, the intent of 
the then current regulations.

Lethality

    To meet the first standard, lethality, FSIS proposed that 
establishments treat ready-to-eat product so as to ensure a specific, 
significant reduction in the number of Salmonella microorganisms, 
therefore eliminating or adequately reducing other vegetative 
pathogenic microorganisms from the product. FSIS did not propose to 
require that any particular means be used to meet the lethality 
standard, although for cooked products FSIS did propose to require a 
heat treatment. FSIS emphasized that cooking did not need to be the 
sole means by which lethality would be achieved. Other applicable 
treatments, such as curing or other controls, might be used in 
combination with cooking to achieve the required lethality.
    FSIS proposed to measure the reduction of pathogenic microorganisms 
in ``x-decimal'' reductions, where x is a number. In this regulation, a 
single ``1-decimal'' reduction represents an expected 90% reduction in 
the number of organisms, i.e., the number of organisms would be 
expected to be reduced by a factor of 10. A ``5-decimal'' reduction 
reduces the number of organisms by an expected factor of 105 
or 100,000.
    In terms of a common logarithm (log10) scale, an ``x-
decimal'' reduction is the same as saying an ``x-log10'' 
reduction. In the proposed regulation, FSIS referred to an ``x-
log10'' reduction as ``decimal'' or ``-D'' reduction. 
However, FSIS feels that it is clearer and more descriptive to use the 
phrase ``x-log10.'' Therefore, throughout the remainder of 
this document and in the final rule language, FSIS will describe 
pathogen reduction values as ``x-log10'' reductions rather 
than ``x-decimal'' or ``-D'' reductions. Thus, a ``x-log10'' 
reduction means that the number of organisms would be expected to be 
reduced by a factor of 10 x . In terms of probability 
distributions, this means that the probability, p, that a given 
organism will survive a ``x-log10'' lethality reduction is p 
= (1/10 x .)\1\
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    \1\ More generally, it is assumed that the distribution of the 
number of surviving organisms given N initial organisms is a 
binomial distribution with parameters N and p.
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    For the cooked beef, roast beef, and cooked corned beef products 
described in Sec. 318.17 and the cooked poultry

[[Page 733]]

products described in Sec. 381.150, FSIS proposed that the lethality 
performance standard be a 7-log10 reduction in Salmonella. 
Traditionally, the primary pathogenic microorganism of concern in these 
cooked products has been Salmonella. Furthermore, the thermal 
destruction of Salmonella in cooked beef products would indicate the 
destruction of most other pathogens.
    In the proposal, FSIS noted that though a 7-log10 
reduction in Salmonella would eliminate or adequately reduce vegetative 
pathogenic microorganisms from these cooked products, a 7-
log10 reduction in Salmonella also may be overly 
conservative in certain processing environments. FSIS also recognized 
that developments in processing technology may indicate that a safe, 
ready-to-eat cooked beef or poultry product could be produced with a 
different level of lethality. The Agency stated, therefore, that it 
would consider revising the lethality performance standard and safe 
harbor example for these products if presented with compelling data and 
invited submissions on this lethality standard.
    For fully cooked, uncured meat patties, as described in 
Sec. 318.23, FSIS proposed that the lethality performance standard be a 
5-log10 reduction in Salmonella. FSIS identified Salmonella 
as the target pathogenic microorganism in fully cooked uncured meat 
patties, as in fully cooked beef products. FSIS had assumed that a 5-
log10 reduction in Salmonella in cooked, uncured meat 
patties would effectively eliminate most other bacterial pathogens of 
concern.
    At the time of the proposal, the processing requirements for ready-
to-eat cooked beef, roast beef, and cooked corned beef, meat patties, 
and cooked poultry products all contained heat treatment requirements 
that, if followed, ensured products met the proposed lethality 
performance standards. FSIS proposed to retain those requirements in 
the regulations as examples of processing methods that would achieve 
the performance standards. And, as stated above, establishments wishing 
to continue their current manufacturing practices could follow these 
safe harbor examples and meet the performance standards.

Stablilization

    FSIS proposed to require that establishments producing any of the 
ready-to-eat products meet the second performance standard, 
stabilization, by preventing growth of spore-forming bacteria that may 
produce toxin either in the product or in the human intestine after 
consumption. If allowed to grow in number, these bacteria can cause 
food borne illness. Means applied to products to bring about the 
lethality of certain pathogenic microorganisms, particularly heat 
treatment, can create a model environment for the multiplication of 
spore-forming bacteria. Spores of Clostridium botulinum, Clostridium 
perfringens, and other spore-forming bacteria can survive cooking and, 
in fact, thrive in the warm product following cooking after competitive 
microorganisms, such as Salmonella, have been eliminated.
    FSIS proposed to require that establishments stabilize each of the 
ready-to-eat products to prevent the germination and multiplication of 
toxigenic microorganisms such as C. botulinum, and allow no more than a 
1-log10 multiplication of C. perfringens. Limiting the 
allowable growth of C. perfringens to a 1-
log10 multiplication would effectively limit the 
multiplication of other, slower growing spore-forming bacteria, such as 
Bacillus cereus. FSIS anticipated that most establishments would meet 
the stabilization performance standards by rapidly cooling products 
following cooking.
    At the time of the proposal, the regulations for cooked beef 
products and cooked meat patties (Secs. 318.17 (h)(10) and 318.23(b)) 
contained chilling requirements to inhibit the growth of spore-forming 
bacteria. Compliance with these requirements would allow establishments 
to meet the proposed stabilization performance standard, so FSIS 
proposed to retain these requirements in the regulations as safe 
harbors. Consequently, meat establishments wishing to continue their 
current manufacturing practices could follow these safe harbor 
examples.
    The regulations for cooked poultry products in Sec. 381.150, 
however, did not contain chilling requirements. FSIS proposed to codify 
as safe harbors the chilling recommendations in FSIS Directive 7110.3, 
``TIME/TEMPERATURE GUIDELINES FOR COOLING HEATED PRODUCTS.'' FSIS 
determined that this chilling directive would constitute a safe harbor 
because compliance would yield cooked poultry products that meet the 
stabilization performance standard and because most, if not all, 
establishments were already following this directive.

Handling

    To meet the third performance standard for the ready-to-eat 
products, FSIS proposed to require that establishments handle product 
to preclude recontamination by infectious pathogenic microorganisms. 
The proposed standard required that no infectious pathogens be 
introduced into the product following processes ensuring lethality or 
stabilization, or after final packaging.
    At the time of the proposal, the regulations for cooked beef 
products (Sec. 318.17(i), (j), and (k)) and for cooked meat patties 
(Sec. 318.23(b)(4)) required that these cooked products be handled 
throughout processing in a manner precluding their recontamination by 
infectious pathogenic microorganisms. FSIS proposed to retain these 
requirements in the regulations as safe harbors. Consequently, meat 
establishments wishing to continue their current manufacturing 
practices could follow these safe harbor examples and meet the 
performance standards.
    The regulations for ready-to-eat poultry products in Sec. 381.150, 
however, did not contain handling requirements. FSIS proposed to codify 
the handling regulations already in place for cooked beef products and 
cooked meat patties as the safe harbor handling requirements for cooked 
poultry products. As with the proposed chilling requirements, FSIS 
determined that these proposed handling requirements for ready-to-eat 
poultry would constitute safe harbors because they represent current 
good manufacturing practices (GMP's) accepted and in general use by 
industry.

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. FSIS determined that 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 might contain infectious pathogenic 
microorganisms after processing and prior to cooking. FSIS proposed, 
therefore, 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 Clostridium 
perfringens, Clostridium botulinum, and other spore-

[[Page 734]]

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.
    At the time of the proposal, the regulations for partially cooked 
and char-marked uncured meat patties (Sec. 318.23(b)(1)(ii) and (iii)) 
and partially cooked poultry breakfast strips (Sec. 381.150(a)) 
required that these products be quickly chilled following partial 
cooking or char-marking, in order to inhibit the growth of spore-
forming bacteria. When applied, these chilling requirements produce 
partially cooked and char-marked products that meet the stabilization 
performance standard. FSIS proposed to retain these requirements in the 
regulations as safe harbors. Consequently, establishments wishing to 
continue their current manufacturing practices could follow these safe 
harbor examples and meet the proposed stabilization performance 
standard.
    FSIS currently 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 proposed to retain 
these labeling requirements in the regulations.

Process Schedule Approval and Validation

    FSIS proposed to require that 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 have on file a written process schedule describing 
the specific operations employed by the establishment to accomplish the 
objectives of the performance standards. This process schedule also 
would be required to contain the related control, monitoring, 
verification, validation, and corrective action activities associated 
with the establishment's procedures. These activities would be similar, 
if not identical, to the control, monitoring, verification, validation, 
and corrective action activities eventually developed by the 
establishment as part of its HACCP plan. Accordingly, FSIS proposed to 
sunset these process schedule requirements as establishments 
implemented HACCP.
    FSIS also proposed to require that the process schedule be 
evaluated and approved for safety and efficacy by a process authority--
a person or organization with expert knowledge in meat and poultry 
process control and relevant regulations. FSIS did not propose to 
preapprove the procedures deemed acceptable by the establishment's 
process authority. 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.
    Also, FSIS proposed to require that prior to the implementation of 
HACCP, establishments validate the process schedule by holding and 
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 proposed to 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. And, like the proposed requirements concerning the 
development, approval, and maintenance of the process schedule, FSIS 
proposed to sunset the process schedule validation requirement as 
establishments implemented HACCP.
    FSIS noted that this particular form of validation may not be 
appropriate in every circumstance and invited comment on the validation 
requirement proposed in this document, specifically as to whether FSIS 
should prescribe a specific method of validation for these process 
schedules, and, whether the proposed testing requirement was, in fact, 
appropriate for ensuring that an establishment's products meet food 
safety performance standards.

Safe Handling Labels

    Sections 317.2(l) and 381.125(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. FSIS proposed, however, to allow ready-to-
eat products to be processed by means other than the time and 
temperature requirements prescribed in these sections, as long as they 
met the performance standards proposed. Therefore, as a result of the 
proposal, safe handling label requirements might not be necessary for 
all ready-to-eat products processed by means other than those 
prescribed time/temperature combinations. Accordingly, FSIS proposed to 
amend Secs. 317.2(l) and 381.125(b), to exempt from the labeling 
requirements ready-to-eat products meeting the proposed performance 
standards.

Comments and Agency Responses

    FSIS received nine comments on the proposed rule from industry and 
an industry consultant, trade associations, a veterinary medical 
association, and a State government. Several of the commenters 
requested that the initial comment period, which was to end on July 1, 
1996, be extended. Commenters were concerned that there might be 
conflicts between the final HACCP rule and codification of safe harbors 
and GMP's. Also, there was a request for more time to develop data to 
support lower lethality values. The Agency responded by extending the 
comment period for this proposal until September 9, 1996. Meanwhile, 
the HACCP rule was published on July 25, 1996, which gave commenters 
time to consider this proposal in light of the final HACCP rule.
    All of the commenters expressed general support for the Agency's 
stated intent to move away from command-and-control regulations. One 
reviewer felt that the proposal provided for adequate assurance of food 
safety while allowing innovation in processing procedures. Some 
commended the Agency for promoting the move towards a HACCP approach 
and welcomed the flexibility to vary production schedules, as long as 
performance standards were met. However, some commenters stated that 
the goal of moving away from command-and-control regulations into a 
HACCP environment was not fully realized in the proposal. Their 
specific objections and Agency responses follow.

Performance Standards and HACCP

    Comment: Several of the commenters were opposed to the Agency 
establishing the type of safety standard that was embodied in the 
proposed performance standards. These

[[Page 735]]

commenters maintained that the proposal could inhibit innovation and 
flexibility and that allowing each plant to develop and specify their 
individual performance standards or food safety objectives would be 
more consistent with HACCP.
    Response: FSIS has determined that HACCP-based process controls 
combined with appropriate food safety performance standards are the 
most effective means available for controlling and reducing harmful 
bacteria on meat and poultry products. In the final rule establishing 
HACCP and pathogen reduction requirements for all official meat and 
poultry establishments, FSIS explained the role played by HACCP and 
pathogen reduction performance standards in its food safety strategy:

    FSIS has concluded that HACCP-based process control, combined 
with appropriate food safety performance standards, is the most 
effective means available for controlling and reducing harmful 
bacteria on raw meat and poultry products. HACCP provides the 
framework for industry to set up science-based process controls that 
establishments can validate as effective for controlling and 
reducing harmful bacteria. Performance standards tell establishments 
what degree of effectiveness their HACCP plans will be expected to 
achieve and provide a necessary tool of accountability for achieving 
acceptable food safety performance. Science-based process control, 
as embodied in HACCP, and appropriate performance standards are 
inextricably intertwined in the Agency's regulatory strategy for 
improving food safety. Neither is sufficient by itself, but, when 
combined, they are the basis upon which FSIS expects significant 
reductions in the incidence and levels of harmful bacteria on raw 
meat and poultry products and, in turn, significant reductions in 
food borne illness.

(61 FR 38811)
    In this rule, FSIS replaces existing, prescriptive cooking and 
cooling requirements for ready-to-eat products with pathogen reduction 
performance standards. These standards set forth the required level of 
food safety performance for specific types of meat and poultry 
processing, but allow for significant flexibility in achieving those 
levels of safety. Allowing individual establishments to develop their 
own performance standards would not provide sufficient accountability 
for achieving an acceptable level of food safety performance.
    FSIS is providing more flexibility in meeting the lethality 
performance standards than that which was proposed by allowing 
establishments to use alternative, and presumably lower, lethalities. 
An establishment may develop and use an alternative lethality if it can 
demonstrate, within its validated HACCP plan or process schedule, that 
its process yields finished, ready-to-eat meat or poultry products with 
reductions of Salmonella and other pathogens equivalent to the 
reductions achieved through compliance with the lethality performance 
standards explicitly provided for in the regulations. Alternative 
lethalities are explained further in the following responses.

Lethality

    Comment: Most commenters agreed that the Agency was scientifically 
justified in proposing that a 5-log10 reduction in 
Salmonella be achieved in ready-to-eat meat patties, but contended that 
the proposed 7-log10 lethality for whole muscle products 
(ready-to-eat cooked beef and poultry products) was excessive. These 
commenters argued that a 5-log10 reduction in Salmonella 
would adequately ensure the safety of all of the fully-cooked meat and 
poultry products. They maintained that achieving a 5-log10 
reduction in Salmonella would eliminate other pathogens of concern, 
which generally are more sensitive to heat treatment. Also, they stated 
that they expect to see relatively low numbers of pathogens on incoming 
raw products.
    One commenter stated that ``obviously, the surface of products, 
which are cooked to achieve a specified internal lethality value, are 
subject to much, much higher lethality.'' The commenter implied that a 
lethality applicable to the interior of a whole cut product resulted in 
a greater lethality on the outside surfaces, where the bacteria lie. 
The commenter specifically suggested that the lethality requirement for 
cooked meat products be reduced from a 7-log10 to a 5-
log10 reduction. The justification of this commenter's 
recommended reduction was based on the measured ``high value'' of 240 
Most Probable Number (MPN)/cm2 of Salmonella reported by FSIS in 
``baseline'' surveys, and a ``safety'' factor of 100.
    Response: In the proposal, FSIS acknowledged that both the current 
cooking requirements and the proposed performance standards for ready-
to-eat whole muscle meat and poultry products, each of which achieves a 
7-log10 reduction in Salmonella, may be overly conservative 
in certain processing environments. Accordingly, FSIS specifically 
requested comment on whether to revise the proposed lethality 
performance standards and regulatory safe harbors for these products.
    Although establishing a single lethality performance standard for 
all ready-to-eat products, as suggested by commenters, would greatly 
simplify the regulations, the commenters did not present information 
that would substantiate a single lethality requirement for all ready-
to-eat products. Furthermore, data collected in FSIS's national 
microbiological ``baseline'' surveys of raw whole and ground meat and 
poultry products 2 indicate that different ready-to-eat 
products require different lethality standards. Because the baseline 
data shows higher levels of Salmonella in poultry than in meat, FSIS is 
establishing higher lethality performance standards for ready-to-eat 
poultry products than for meat. This difference is necessitated by need 
for lethalities that will render raw poultry into ready-to-eat poultry 
products safe for consumption. FSIS already has established different 
Salmonella standards for different types raw products owing to the 
different prevalences of Salmonella found in the baselines for raw meat 
and poultry (Secs. 310.25(b)(1) and 381.381.94(b)(1)).
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    \2\ Copies of reports on FSIS's Nationwide Microbiological 
Baseline Data Collection Programs are available in the FSIS Docket 
Room, U.S. Department of Agriculture, Room 102, Cotton Annex, 300 
12th St. SW, Washington, DC 20250-3700.
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    After considering the comments and information collected from the 
baseline studies, FSIS is requiring that establishments achieve a 7-
log10 reduction of Salmonella or an equivalent probability 
that no viable Salmonella organisms remain in the finished product in 
ready-to-eat poultry products and a 6.5-log10 reduction of 
Salmonella or an equivalent probability that no viable Salmonella 
organisms remain in the finished product in ready-to-eat cooked beef, 
roast beef, and cooked corned beef products. Effectively, processing 
that achieves these specific lethalities or their equivalents will 
result in ready-to-eat products that pose no health risks to 
consumers.3
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    \3\ A technical report explaining the lethality performance 
standards and their equivalent probabilities, ``Lethality and 
Stabilization Performance Standards for Certain Meat and Poultry 
Products: Technical Paper,'' is available from the FSIS Docket Room, 
U.S. Department of Agriculture, Room 102, Cotton Annex, 300 12th St. 
SW, Washington, DC 20250-3700.
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    FSIS is not finalizing the lethality performance standards proposed 
for ready-to-eat comminuted meat patty products. Compliance with the 
current requirements concerning the production of ready-to-eat meat 
patties effectively achieves a 5-log10 reduction in 
Salmonella. FSIS proposed to retain this same level of pathogen 
reduction in both the performance standard and the

[[Page 736]]

safe harbor for this product. However, in the course of developing this 
final regulation, after examining the baseline surveys of raw ground 
meat products, FSIS has concluded that a higher lethality may be 
necessary to produce ready-to-eat meat patties that pose no health risk 
to consumers. Therefore, FSIS is considering establishing a new 
lethality performance standard for ready-to-eat meat patties. Until 
further rulemaking, the current heat-processing requirements for ready-
to-eat meat patties will remain in effect.
    In this rule, FSIS is finalizing lethality performance standards 
that, effectively, ensure that even a ``worst case'' product presents 
no health risk to consumers. The Agency defined worst case product by 
considering data from the FSIS's national baseline studies. 
Specifically, the worst case was defined as an approximate 97.5% upper 
bound for the number of organisms in a sample with the highest measured 
density from each baseline survey. This approach of determining a 
``worst case'' is more appropriate from a scientific and statistical 
standpoint than using an arbitrary 2-log10 safety factor 
over a given ``high value'' measurement (another common approach), in 
that it allows FSIS to better address any uncertainty associated with 
the ``worst case'' value.
    As stated above, FSIS used the baseline surveys for both raw whole 
and ground products in defining ``worst case product'' and determining 
the necessary lethalities. The ``worst case'' definition and lethality 
for ready-to-eat poultry products were determined using the raw ground 
poultry surveys. FSIS recognizes that the raw ground product survey 
data has certain limitations. For example, the raw ground product 
surveys did not cover all of the summer months and therefore do not 
completely represent possible seasonal variations in the prevalence and 
levels of pathogenic microorganisms. Nevertheless, the raw ground 
product surveys represent the most complete, recent data set available 
for the Agency's purposes.
    Furthermore, FSIS has concluded that the raw ground product surveys 
are more appropriate as a basis for these performance standards than 
are epidemiological data, such as quantitative data from meat and 
poultry products implicated in outbreaks of food borne illness. 
Products implicated in outbreaks often have been temperature abused. 
Because the cause of the temperature abuse, as well as the bacterial 
levels in the implicated product prior to the abuse, are often unknown, 
outbreak data were not deemed useful in developing these performance 
standards.
    To assure that ``worst case'' product subjected to the finalized 
lethality requirements (with subsequent proper handling) would present, 
effectively, no health risk to the consumers, FSIS calculated the 
probability distribution for the number of organisms that survive 
cooking. These calculations demonstrate that it is highly unlikely that 
worst case product subjected to the required lethality would ever 
contain more than a very few Salmonella organisms in 100 grams of 
product. FSIS also emphasizes that, even though it employed probability 
calculations regarding the survival of Salmonella in finished, ready-
to-eat product to develop the performance standards, if it were to find 
viable pathogens of concern in any ready-to-eat product, FSIS would 
consider that product to be adulterated.
    In regard to the comment contending that whole muscle meat products 
are inherently safer than comminuted meat products, no conclusive 
information was presented to FSIS that demonstrated that the 
distributions of bacteria on ground and whole product produced under 
good manufacturing practices would present comparatively higher or 
lower risks to consumers. In fact, research suggests that in some 
situations risks could be higher in whole products than in ground 
products.
    Research has suggested that the lethality on the outside surface 
might not always be greater than that of the interior of product during 
cooking. Blankenship has shown, through an inoculation study,\4\ that 
roast beef cooked in an oven at 229 deg.F resulted in no Salmonella 
being recovered from the roast's center, while Salmonella survived on 
the roast's surface, even though an internal temperature of 147.5 deg. 
F was achieved. The reason for this phenomenon was elucidated by 
Goodfellow and Brown \5\ who showed that without adequate conditions of 
humidity, Salmonella could survive on dry roasted beef surfaces during 
low temperature dry roasting. Therefore, the research shows that, under 
some circumstances, cooking does not always result in a higher 
lethality on the surface of a product versus the interior of the 
product. It was for this reason that the previous cooked beef, roast 
beef, and cooked corned beef regulations (9 CFR 318.23) required 
humidity to be controlled during the cooking process, and the lethality 
performance standards for this regulation were clarified by adding the 
phrase ``throughout the product.''
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    \4\ Blankenship, L.C. 1978. Survival of a Salmonella typhimurium 
Experimental Contaminant During Cooking of Beef Roasts. Appl. 
Environ. Microbiol. 35:1160.
    \5\ Goodfellow, S.J. and Brown, W.L. 1978: Fate of Salmonella 
inoculated into beef for cooking. J. Food Protect. 41:598-605.
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    Further, it is possible for intact whole muscle cuts, sectioned and 
formed products, and chunked and formed products, to have high 
microbial levels on small portions of the product (``hot spots'').\6\. 
A piece of meat with high levels of Salmonella could end up anywhere in 
the chunked/formed roast, resulting in an uneven distribution of 
Salmonella. This uneven distribution is in sharp contrast to the more 
even distribution of Salmonella that would be expected in ground 
product such as ground beef. Therefore, in such a case, the amount of 
lethality needed to reduce Salmonella for a given amount in whole 
muscle cuts and in chunked/formed product may exceed that needed for 
ground product.
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    \6\ Surkiewicz, B.F., et al. (1975) Bacteriological Survey of 
Raw Beef Patties Produced at Establishments under Federal 
Inspection, Applied Microbiology, p. 331-334.
---------------------------------------------------------------------------

    Therefore, because in some situations risks could be higher in 
whole muscle and chunked/formed products than in ground products, FSIS 
will continue to require a higher lethality reduction in Salmonella for 
cooked beef, roast beef, and cooked corned beef than that which is 
currently required for meat patties. However, as mentioned above, FSIS 
is reconsidering the lethality reduction in Salmonella currently 
required for ready-to-eat meat patties.
    Comment: A few commenters recommended that the industry be allowed 
to set plant- and process-specific lethality performance standards, 
since HACCP requires a hazard analysis resulting in appropriate food 
safety process controls. These commenters claimed that the proposed 
performance standards would limit an establishment's flexibility in 
employing alternative lethalities and inhibit innovation in pathogen 
reduction. One commenter said explicitly that ``there must be an option 
for use of other scientifically valid lethality values.'' This 
commenter suggested how other scientifically valid lethality values 
could be derived, by allowing ``a lower level of lethality as long as 
the food safety objectives are met (i.e., a similar probability of 
survival of the pathogens of concern).'' The same commenter also stated 
that ``The Agency must provide a clear and reasonable mechanism for 
review and acceptance of alternative values.''

[[Page 737]]

    Response: The Agency agrees and will allow establishments to design 
and employ processes with lethalities different from, but effectively 
equivalent to, those specifically provided for in this rule. FSIS did 
not intend to limit an establishment's flexibility in designing 
processes that would produce safe food. FSIS stated in the preamble to 
the proposed rule that it ``recognizes * * * that a safe, ready-to-eat 
* * * product could be produced with a different level of lethality.'' 
An establishment that develops and uses an alternative lethality will 
be required to demonstrate, within its validated HACCP plan or process 
schedule, that its process yields finished, ready-to-eat meat or 
poultry products with reductions of Salmonella and other pathogens 
equivalent to the reductions achieved through compliance with the 
lethality performance standards explicitly provided for in the 
regulations. As suggested by the commenter, establishments will need to 
evaluate processes using alternative lethalities with criteria based on 
calculated probabilities of surviving pathogens following processing.
    To develop criteria for evaluating the effectiveness of processes 
using alternative lethalities, it will be necessary for the processor 
to define, using associated statistical criteria, the expected 
characteristics of the treated product after processing for assumed 
pre-processing product conditions. For example, an establishment using 
an alternative lethality would specify that the probability of there 
being more than x surviving organisms in the finished product is no 
more than p, given that the ``worst case,'' pre-processed product 
contained at least y organisms. Of course, establishments would need to 
use an alternative lethality that results in a finished product that is 
as safe as product produced using the lethality explicitly set out in 
this regulation (a 6.5 or 7 log10 reduction of Salmonella).
    The performance standards describe a property of the actual 
process: the lethality performance standards in this rule require that 
processing achieve an x-log10 lethality reduction in 
Salmonella. Practical difficulties would have been created for a large 
portion of the industry if this regulation were stated purely in terms 
of the statistical criteria that would indicate an adequate reduction 
of Salmonella. It would be difficult for many establishments to 
demonstrate that a process achieves an adequate reduction of Salmonella 
using statistical criteria. Such a demonstration would entail extensive 
scientific research beyond the capability of most establishments. 
Therefore, to allow for processing flexibility while ensuring product 
safety, FSIS is finalizing specific lethality performance standards in 
the regulations, but allowing establishments to use alternative 
lethalities that achieve an equivalent probability that no viable 
Salmonella organisms remain in the finished product.
    As explained in the previous response, FSIS determined that 
processes meeting the finalized lethality performance standards will 
render ``worst case'' raw product, as defined by FSIS's national 
baseline studies, into finished product that, effectively, poses no 
health risk to the consumer. In determining that processes meeting the 
performance standards will ensure a safe product, the Agency made 
conservative assumptions concerning the actual lethality achieved 
throughout the product. The Agency acknowledges that it might be 
possible for producers to scientifically demonstrate that these 
lethality assumptions or the Agency's defined ``worst case'' would not 
be applicable for their particular processing situation. An 
establishment could then design a process with lethality values that 
are different from those provided in this rule, but that would still 
yield a product that meets the final conditions equivalent to those 
achieved by the lethality performance standard.
    An establishment developing an alternative lethality treatment or 
treatments and assuming an initial product condition other than the 
``worst case'' would need to include in its HACCP plan or process 
schedule scientific data and statistical validation that would justify 
the assumed initial conditions and ensure that these would not change. 
For example, an establishment may be able to demonstrate that the 
number of Salmonella is not uniformly distributed throughout a 
particular type of product. The establishment also might demonstrate 
that due to husbandry and slaughter practices, the worst case product 
processed within an establishment differs from the worst case scenarios 
developed for this rule. Demonstrations of initial product conditions 
solely by statistical means will be unacceptable.
    Generally, an establishment will need to demonstrate in its HACCP 
plan or process schedule how its alternative lethality treatment(s) 
provides for a level of safety in its finished product equivalent to 
that provided for by compliance with the lethality performance 
standards explicitly provided in this rule. The establishment will need 
to demonstrate the relationships between the lethality treatment(s) and 
the specific characteristics of a product, such as physical and 
chemical properties. This demonstration could involve the use of heat 
transfer equations and should account for all variables that would 
affect lethality (e.g., size of product, humidity, density, thermal 
conductivity, specific heat, shape, product composition, and strain of 
organism).
    Finally, establishments employing alternative lethalities will need 
to demonstrate, within their HACCP plans or process schedules, that 
they have validated their processes as being effective in ensuring 
product safety. Section 417.4(a)(1) of the HACCP regulations sets forth 
the ``initial validation'' requirements for establishments under HACCP:

    Upon completion of the hazard analysis and development of the 
HACCP plan, the establishment shall conduct activities designed to 
determine that the HACCP plan is functioning as intended. During 
this HACCP plan validation period, the establishment shall 
repeatedly test the adequacy of the CCP's, critical limits, 
monitoring and recordkeeping procedures, and corrective actions set 
forth in the HACCP plan. Validation also encompasses reviews of the 
records themselves, routinely generated by the HACCP system, in the 
context of other validation activities.

FSIS will expect establishments employing alternative lethalities, but 
not yet operating under HACCP, to undertake similar actions as part of 
the validation activities documented in their process schedules.
    As mentioned above, FSIS is making available a technical paper 
explaining the derivation of the lethality performance standards.\7\ 
Establishments are encouraged to use this paper when developing 
alternative lethalities. In the paper, FSIS explains the methodology 
used to calculate the probability of remaining Salmonella organisms in 
treated product.
---------------------------------------------------------------------------

    \7\ ``Lethality and Stabilization Performance Standards for 
Certain Meat and Poultry Products: Technical Paper'' is available 
from the FSIS Docket Room (see footnote 3).
---------------------------------------------------------------------------

    Comment: Some commenters suggested that it would be appropriate to 
allow combinations of treatments or alternatives to achieve a level of 
safety equivalent to that provided by the specified lethality.
    Response: The Agency agrees and will allow combinations of 
treatments or alternatives to meet the performance standards for 
lethality, so long as a cooking step is included and process schedules 
are validated by a knowledgeable processing authority.

[[Page 738]]

FSIS has amended the lethality performance standards to clarify that 
one or more controlled intermediate steps applied to raw product may 
form part of the basis for equivalency with the specified lethality. 
Importantly, the net, or overall, effect of the entire process must be 
demonstrated to effect a required reduction in Salmonella. The 
following example, provided in part by one of the commenters, clarifies 
the Agency's intent:

    A controlled intermediate step(s) applied to the untreated raw 
product may form part of the basis for the equivalency. Assume that 
a 7-log10 reduction is required. A 3-log10 
attained by an anti-microbial spray treatment is followed 
immediately by a 4-log10 reduction using a heat 
treatment. The combined 3-log10 plus 4-log10 
reduction could result in a net 7-log10 reduction. This 
7-log10 reduction should be confirmed with reference to 
the level of Salmonella on the initial raw product compared to the 
level attained after the second or final treatment. This 
confirmation is needed because there may be an interactive effect 
between the treatments. A primary treatment could, for example, 
increase or decrease the heat resistance of Salmonella if heat were 
the second treatment. Secondly, certain conditions, such as time/
temperature abuse between the steps could have an unanticipated 
negative affect, allowing pathogens to grow between treatments.

    If treatments or interventions (organic rinses, steam vacuuming, 
steam pasteurization, etc,) are used in combination with a heat 
treatment, it is the responsibility of the establishment and processing 
authority to ensure not only the cumulative equivalency of a 6.5-
log10 or 7-log10 lethality for Salmonella in 
ready-to-eat beef or poultry products, respectively, but also the 
reduction/inactivation of all other food borne pathogens of concern. 
The Agency has revised the lethality performance standard to clarify 
this point. The lethality performance standard now states that 
establishments are responsible not only for the required reduction in 
Salmonella, but also for the ``reduction of other pathogens and their 
toxins or toxic metabolites necessary to prevent adulteration, * * * 
throughout the product'' This phrase was added to clarify that, while 
Salmonella is the reference organism and its destruction in most cases 
will indicate adequate reduction of other pathogens of concern, it is 
the responsibility of the establishment to demonstrate and ensure that 
the final product is ultimately safe. ``Throughout the product'' is 
added to indicate FSIS's intent that the process cannot affect only the 
surface or restricted portions of the product.

Stabilization

    Comment: As with the lethality standards, a few commenters 
recommended that the industry be allowed to set establishment- and 
process-specific stabilization performance standards, since HACCP 
requires a hazard analysis resulting in appropriate food safety process 
controls.
    Response: The Agency has decided to maintain the performance 
standards with regard to multiplication of Clostridium perfringens and 
Clostridium botulinum. As noted in the HACCP final rule, Clostridium 
perfringens is ubiquitous in the environment so that controls at 
slaughter would not necessarily be effective in controlling the 
occurrence of this organism in raw product. Therefore, product cooling 
or stabilization is a critical factor in preventing the multiplication 
of this organism.
    Comment: One commenter suggested that FSIS allow 1.5 logs of 
multiplication of Clostridium perfringens. The commenter stated he had 
data to support this level of reduction, but has yet to provide it. 
This commenter also recommended that the Agency convene a technical 
conference of appropriate scientists to develop a consensus on the 
stabilization performance standard and have the performance standard 
addressed by the NACMCF.
    Another commenter suggested allowing 10 generations (approximately 
3 logs) of Clostridium perfringens multiplication as the performance 
standard. This commenter's reason for permitting a 3 log increase is 
based on an assumed surviving spore population, after cooking, of 10 
Clostridium perfringens per gram, and the commenter's assumption that 
10 \4\ per gram is generally considered to be the upper acceptable 
limit for finished product.
    Response: The performance standard provides that any more than 1-
log10 multiplication of Clostridium perfringens will 
adulterate the product for the following reasons: First, viable counts 
of 10 \5\ or greater of Clostridium perfringens/gram have been 
recommended by the U.S. Centers for Disease Control and Prevention as 
one criteria for incriminating Clostridium perfringens as the causative 
agent of food borne illness in finished product \8\ (although foods 
responsible for Clostridium perfringens outbreaks usually contain at 
least 10 \6\ vegetative Clostridium perfringens cells per gram \9\ 
,\10\). Second, in the FSIS ground product surveys, some 
samples were found to contain more than 1000 Clostridium perfringens/
gram (the level on one ground chicken sample was 11,000 CFU/gram). 
Thus, there is some probability that greater than 10 \4\ Clostridium 
perfringens/gram can occur in raw product on rare occasions. It is a 
conservative assumption (with respect to public health) that the great 
majority of Clostridium perfringens in the raw product are spores. 
Heating activates the spores which during the cooling become vegetative 
cells that can multiply to hazardous levels. Given that there can be 
more than 10 \4\ Clostridium perfringens (spores) per gram on raw 
product, it is possible that there could be as many as 10 \4\ 
vegetative Clostridium perfringens/gram of these surviving, after 
cooking, in the product.\11\ Therefore, the Agency, using the 
aforementioned CDC criteria as an upper limit that should not be 
exceeded, determined that a limit of no more than 1 log10 
growth of Clostridium perfringens is appropriate to ensure that there 
would be no more than 10 \5\ Clostridium perfringens per gram on the 
finished product after cooling.
---------------------------------------------------------------------------

    \8\ Labbe, R. (1989) Clostridium perfringens. In M. Doyle (ed.), 
Food borne Bacterial Pathogens, Marcel Dekker, Inc., New York. pp. 
210, 213.
    \9\ Hauschild, A. (1975) Criteria and Procedures for Implicating 
Clostridium Perfringens in Food-borne Outbreaks. Canadian Journal of 
Pubic Health. 66: 388-392.
    \10\ McClane, B.A. (1992) Clostridium Perfringens Enterotoxin: 
Structure, Action, and Detection. Journal of Food Safety. 12:237-
252.
    \11\ For further detail refer to the ``Compliance Guidelines'' 
concerning stabilization performance attached to this document.
---------------------------------------------------------------------------

    Finally, although the Agency has not convened a technical 
conference to develop this performance standard, the Agency did 
informally discuss the standard with several experts in the field of 
clostridial research. These experts agreed that limiting relative 
growth of Clostridium perfringens to no more than 1-log10 
would be reasonable with respect to product safety, albeit somewhat 
conservative.
    Comment: Some commenters felt that there was little justification 
for including Clostridium botulinum as part of the performance 
standard. They maintained that it is unlikely to be present in meat and 
poultry with its sparse distribution (about 1/1000 gram) in raw meat; 
that the risk of Clostridium botulinum is low; limiting Clostridium 
perfringens would effectively limit growth of the other spore formers 
(e.g., Clostridium botulinum and Bacillus cereus), since Clostridium 
perfringens has a shorter generation time and

[[Page 739]]

broader range of temperature growth; and, that the germination of 
Clostridium botulinum spores, per se, without multiplication, was not 
dangerous.
    Response: The Agency is resolved to keep Clostridium botulinum in 
the performance standard because severe cooling deviations could 
potentially allow Clostridium botulinum multiplication resulting in 
toxin production. However, the term ``germination'' has been removed 
from the performance standard as suggested, since it is expected that 
processors could not completely prevent germination. While in recent 
years few, if any, cases of botulism have resulted from commercially 
produced fully cooked uncanned meat and poultry products, many food 
scientists feel that the risk has increased with the advent of vacuum-
packaged products. While the risk still may remain low, the 
consequences of botulism are often catastrophic.
    Although both Clostridium perfringens and Clostridium botulinum 
will remain in the performance standard, a process authority may choose 
to consider Clostridium perfringens as a reference organism to 
demonstrate that the performance standard was met. That is, if time, 
temperature, and intrinsic properties of the product have been shown to 
preclude over one log multiplication of Clostridium perfringens, then 
multiplication of Clostridium botulinum, which multiples much more 
slowly, would be unlikely to have occurred.
    Comment: Some of the commenters strongly objected to proposed 
codification of cooling guidelines for cooked poultry products (FSIS 
Directive 7110.3, ``Time/Temperature Guidelines for Cooling Heated 
Products'') as safe harbors. One commenter agreed that the application 
of this Directive to partially cooked poultry breakfast strips may be 
acceptable, but felt that the proposal implies the Directive is 
applicable to all poultry products. For instance, the commenter claimed 
that the guidelines in Directive 7110.3 ``are not physically 
attainable'' for cooked turkey roasts and other similar large mass 
products because they were developed from data derived from 50 ml 
samples of ground chili-type product in polyethylene tubes. This 
commenter contended that the roast beef rules in 9 CFR 318.17 (h)(10) 
are more applicable to turkey roasts, but may not be applicable to all 
poultry products, hence this part of the safe harbor should be 
subjected to further scientific study. This commenter also stated that 
relative to cooling, it was imperative that the Agency clarify its 
intent with respect to poultry products. Finally, some commenters 
stated that the application of the cooling guidelines to partially 
cooked and char-marked meat patties was especially unwarranted, because 
these products pose no more hazard than other raw products.
    Response: There has been no constraint against using the cooling 
requirements in the roast beef regulation for chilling whole poultry 
products. Further, there is no reason why any of the cooling safe 
harbors for fully cooked and partially cooked products could not be 
used across product categories (whole, ground or comminuted), 
regardless of the species of origin of the tissue. Research conducted 
by the Agricultural Research Service demonstrates that the cooling 
control points specified in the roast beef regulation could safely be 
applied to ground beef.\12\ It must be understood that though these 
cooling guidelines and regulations were written at different times, 
effective use of any of them will satisfy the performance standard. 
Therefore, it is the intent of this rule that the cooling guidelines 
and regulations can freely be interchanged among product categories 
without requiring the approval of a processing authority.
---------------------------------------------------------------------------

    \12\ Juneja, V.K., et al. (1994) ``Influence of Cooling Rate on 
Outgrowth of Clostridium perfringens Spores in Cooked Ground Beef.'' 
J. Food Prot. 57(12):1063-1067.
---------------------------------------------------------------------------

    The safe harbors for achieving the stabilization performance 
standards have withstood the test of time; no cases of food borne 
illness due to the clostridia when these times and temperatures are 
followed have been documented. Admittedly, the current safe harbors for 
cooling contain a margin of safety in meeting the performance standard. 
However, barring mechanical or electrical failure of equipment, the 
time/temperature combinations in the safe harbors for cooling are 
easily achieved.
    Implicit and of paramount importance is that cooling be continuous 
between the stated temperature control points. Also important is that 
cooling between the temperatures of 130  deg.F and 80  deg.F, the range 
of most rapid Clostridium multiplication, be accomplished quickly, as 
suggested in Directive 7110.3. The upper limit for growth of 
Clostridium perfringens is about 125-126  deg.F.\13\
---------------------------------------------------------------------------

    \13\ Juneja, V.K., et al. 1996. ``Interactive Effects of 
Temperature, Initial pH, Sodium Chloride, and Sodium Pyrophosphate 
on the Growth Kinetics of Clostridium perfringens.'' J. Food Prot. 
59(9):963-968.
---------------------------------------------------------------------------

    Finally, in response to the comment that stabilization performance 
standards for partially cooked poultry products are unwarranted, FSIS 
disagrees and the standards will be adopted as proposed. Partial 
cooking can allow heat shocking of clostridial spores, which can 
germinate during cooling and become vegetative cells that multiply. 
Therefore, the consumer potentially could receive a partially cooked 
product containing a high number of vegetative clostridial cells. If 
the consumer undercooked the product, there would be an increased risk 
that the number of vegetative clostridial cells would survive and 
increase to hazardous levels. Consequently, it is important that 
processors control clostridial growth as required by the performance 
standard.

Handling

    Comment: There were a number of comments concerning the proposed 
provisions for sanitary handling. Many of the commenters insisted that 
this performance standard was unnecessary, being adequately covered by 
both the Agency requirement for Sanitation SOP's and GMP's that are 
already accepted by the industry. One stated that the requirement for 
Sanitation SOP's was in itself contrary to the principles of HACCP, and 
that the Agency should allow individual plants to determine necessary 
sanitation procedures. Nevertheless, this commenter stated they could 
support the requirement for Sanitation SOP's if it were not overlaid 
with this additional performance standard. This commenter also reminded 
the Agency of a phrase in the background to the final HACCP rule 
stating that current GMP's, already accepted by industry, encompass the 
proposed handling performance standards. Also, some commenters 
questioned the necessity of this performance standard for poultry, 
stating that handling requirements for poultry were based on GMP's.
    Some of the commenters felt that the safe harbors for handling 
remained in the realm of command-and-control regulations, and contrary 
to HACCP principles, especially in regard to the stated specifications 
concerning the use of sanitizers and outer garments. One commenter 
suggested that the Agency should not prescribe how to reduce cross 
contamination. Instead the commenter suggested that the rule should 
have a performance standard stating that cross-contamination should be 
less than one pathogen per 100 grams of finished product.
    Response: The Agency had many reservations concerning the addition 
of this performance standard, anticipating that it would be perceived 
as redundant and duplicative of other requirements. However, the Agency 
was also

[[Page 740]]

concerned that handling GMP's, while widely practiced by industry, were 
not required by regulation. Further, though FSIS is now requiring 
establishments to develop and implement Sanitation SOP's, there is no 
specific requirement as to their level of detail, which will vary in 
accordance with the needs, requirements, and complexity of the specific 
plant and its operations. Therefore the Agency was concerned that 
handling might be inadequately addressed by some establishments.
    Ultimately, in consideration of the numerous comments, the Agency 
decided that it is consistent with HACCP principles for establishments 
to be free to devise the specific actions, practices, and procedures 
necessary to ensure a safe final product. Also, the Agency agrees that 
at least general provisions for handling and sanitation are contained 
in the Sanitation SOP requirements, and it did not want to impose 
duplicative requirements that would be burdensome in most cases. 
Accordingly, all handling performance standards have been removed from 
the requirements finalized in this rule.

Process Authority

    Comment: Commenters raised concerns about insufficient detail 
regarding the qualifications required of persons acting as process 
authorities. Also, two commenters were concerned that FSIS inspection 
personnel may not have the qualifications to evaluate the procedures 
recommended by the process authority.
    Response: The Agency has defined ``process authority'' as a person 
or organization with expert knowledge in meat or poultry production, 
process control, and relevant regulations. The Agency has decided that 
further specifications regarding the qualifications of a process 
authority would limit the flexibility needed by industry to develop 
customized, effective processes and process controls. In regard to 
inspection personnel qualifications, FSIS does not intend for its 
inspectors to evaluate the process authority-approved procedures for 
efficacy. FSIS has, however, initiated an aggressive national training 
effort for all inspection personnel regarding their roles in verifying 
HACCP plans and plant performance.

Testing and Other Validation Activities

    Comment: Several commenters felt that the validation requirements 
for processing schedules were too prescriptive and poorly defined in 
the rule, although somewhat better defined in the preamble. Some of the 
commenters maintained that the hold and test requirement would inhibit 
flexibility and be burdensome, costly, and contrary to the principles 
of HACCP. One commenter stated that it could result in false 
conclusions of product safety, because the process is designed to 
handle extremes greater than that which would be presented in everyday 
samples. One commenter, citing the alternatives the Agency previously 
presented for E. coli O157:H7 testing of dry and semi-dry sausages, 
stated that a flexible precedent was already set.
    A few commenters stated that challenge studies could also be 
construed as another costly and inflexible requirement. They claimed 
that ultimately this requirement would not allow a processing authority 
to validate new or altered processing schedules by other means, such as 
material gleaned from the scientific literature, heat distribution or 
penetration studies, or any other available, scientifically supportable 
means to assure product safety. One commenter stated that this 
requirement would require validation studies for food borne pathogens 
that did not pose a relevant risk for the intended product. And, two 
commenters maintained that this requirement implies that the Agency 
expected challenge studies to be conducted in the establishment, before 
or even after product release. Such studies could irresponsibly expose 
equipment, product, and ultimately the consumer to food borne 
pathogens.
    Response: The Agency agrees with the comment regarding the hold and 
test requirements and is removing this requirement from the rule. 
Otherwise, the Agency is adopting the validation requirements. FSIS 
intends for processing authorities to have the flexibility to validate 
new or altered processes by any reasonable and scientifically 
supportable means.
    It was not the intent of FSIS to require challenge studies and the 
Agency does not expect such studies to be conducted in the plant. This 
would indeed risk equipment contamination, product contamination, plant 
workers, and ultimately the public health. Challenge studies, while 
often appropriate and definitive, should be conducted only in the 
laboratory under the auspices of a process authority. The Agency has 
modified the regulations to accommodate these concerns and clarify the 
intent relative to process validation.

Safe Harbors and Performance Standards

    Comment: Many of the commenters fully supported the concept of 
establishing performance standards that allow flexibility in processing 
while retaining regulatory safe harbors for use by establishments that 
prefer to follow existing procedures already accepted by the Agency as 
providing adequate food safety. Some, however, argued that the proposed 
safe harbors are prescriptive, inflexible, and inconsistent with HACCP. 
One commenter supported performance standards, but felt that safe 
harbors were too reminiscent of the command-and-control mode of 
inspection.
    Response: By proposing performance standards that could be met 
through adherence to the earlier regulations, FSIS intended to create 
regulatory safe harbors for establishments that wished to follow 
procedures already accepted by the Agency as providing adequate food 
safety. The Agency proposed to retain these safe harbors in the 
regulations as examples of how to produce meat and poultry products 
that meet the performance standards. FSIS believed that these examples 
would assist small or new establishments that do not have the resources 
to develop customized process schedules. FSIS acknowledged that the 
regulatory safe harbors contained many prescriptive requirements, but 
made clear they would be provided only as examples of how to meet the 
performance standards; they would not be requirements.
    To alleviate concerns of commenters, FSIS will not retain the safe 
harbors in the regulations, but instead provide them as compliance 
guidelines. The safe harbor compliance guidelines for ready-to-eat 
cooked, roast, and corned beef products, fully and partially cooked 
meat patties and poultry products are attached to this rule as 
Appendices A and B (``Compliance Guidelines for Meeting Lethality 
Performance Standards for Ready-to-Eat Meat and Poultry Products'' and 
``Compliance Guidelines for Cooling Heat-Treated Meat and Poultry 
Products (Stabilization)''). Also, the Agency is currently developing a 
process to ensure that the safe harbor guidelines will be readily 
available to all interested parties.
    FSIS also had proposed to exempt establishments that followed the 
regulatory safe harbors from the proposed process schedule 
requirements. However, because FSIS is removing the safe harbors from 
the regulations and issuing them as guidelines, such an exemption is 
impossible; establishments cannot be exempted from a regulatory 
requirement based on compliance with a nonregulatory guideline.
    Establishments choosing to follow the safe harbor guidelines may 
use those

[[Page 741]]

guidelines as their process schedules. FSIS will consider such process 
schedules validated, since they will consist of processing methods 
already accepted by the Agency as effective. As proposed, therefore, 
establishments affected by this rule should not have to change their 
current processing practices.
    Comment: One commenter suggested that it would be appropriate to 
replace safe harbors with Hazard Control Performance Standards that 
would prescribe specific numerical standards for reduction of pathogens 
on hands and food contact surfaces. Another recommended that the Agency 
codify only ``food safety objectives,'' and that neither performance 
standards nor safe harbors should be codified as they would inhibit 
flexibility and innovation.
    Response: Promulgation of only quantifiable hazard control 
performance standards, such as determining microbial counts on food 
contact surfaces or fingertips, would require extensive resources to 
implement and monitor. The Agency has determined that this would be an 
unreasonable and unnecessary burden for industry, especially since 
other alternatives would be equally effective.
    In regard to establishing only food safety objectives, FSIS has 
determined that clearly-defined performance standards and HACCP are 
both necessary for improving food safety. Performance standards and 
HACCP provide meat and poultry establishments with the incentive and 
flexibility to adopt innovative, science-based processing procedures 
and controls, ensure safety for consumers, and provide objective, 
measurable standards, compliance with which can be verified through 
Agency inspectional oversight.
    Comment: Some commenters maintained that having safe harbors would 
discourage establishments from conducting hazard analyses and from 
taking responsibility for the safety of their processes for specific 
products.
    Response: Compliance with the safe harbors will effectively exempt 
some establishments from developing process schedules prior to 
developing and implementing HACCP plans; establishments following safe 
harbor guidelines may use the guidelines as validated process 
schedules. However, all official establishments will be required to 
conduct hazard analyses as part of HACCP plan development regardless of 
whether they follow the safe harbor examples. Further, FSIS considers 
following a safe harbor example to be a legitimate way of taking 
responsibility for ensuring the safety of meat and poultry products. 
The safe harbors are examples of processing methods proven to ensure 
the production of safe meat and poultry products.
    Comment: Commenters also expressed concerns that inspection 
personnel would be less willing and able to evaluate or accept 
alternatives to safe harbors.
    Response: The Agency is providing training for all inspection 
personnel to assure a knowledgeable and capable work force that will be 
prepared to deal with questions concerning performance standards and 
safe harbors. A technical support center, staffed with highly 
experienced personnel to provide clarification and guidance to 
inspection personnel, has been established.

Recommended Amendments to Specific Safe Harbors

    Comment: Several commenters submitted recommendations for revising 
the processing requirements in the safe harbors. For example, one 
commenter recommended that the time-temperature combinations in the 
table ``Permitted Heat-Processing Temperature/Time Combinations for 
Fully-Cooked Patties'' should be amended to include temperatures as low 
as 130 deg.F to enable lower temperature heat treatment processes such 
as sous vide to be used.
    Response: FSIS has revised the safe harbor guidelines for ready-to-
eat cooked, roast, and corned beef products to include processes 
ensuring a 6.5 log10 reduction in Salmonella, as well as the 
7-log10 reduction required by the previous regulations. 
Otherwise, unless safe harbor requirements are found to be insufficient 
for producing meat and poultry products meeting the performance 
standards, FSIS sees no need to revise these provisions. If an 
establishment wishes to manufacture meat or poultry products by means 
other than those contained in the safe harbors, it may do so, provided 
they comply with the applicable requirements (e.g., meeting performance 
standards, developing and validating a process schedule, or operating 
under HACCP).
    In response to the suggestion that temperatures as low as 130 
deg.F be allowed for processing ready-to-eat meat patties, the Agency 
will consider this comment as it reconsiders lethality requirements for 
ready-to-eat meat patties. In general, any time/temperature combination 
that will achieve the lethality performance standard would be 
acceptable. However, establishments employing processing methods other 
than those described in the safe harbors will be required to develop 
and implement process schedules or HACCP plans. FSIS does not plan to 
regularly amend the safe harbors to account for processing variations. 
The safe harbors are only examples of how an establishment can meet the 
performance standards.
    Comment: One commenter argued that humidity is not a significant 
control factor in achieving lethality and, therefore, requirements 
regarding humidity should be removed from the safe harbors. The 
commenter claimed that there has been no link established between the 
failure to control humidity and the incidence of food borne disease.
    Response: The Agency does not agree. In the late 1970's there were 
several food borne disease outbreaks caused by the consumption of 
``rare'' roast beef. At the time of these outbreaks, there were no 
regulations specifying the minimum internal temperature and humidity 
requirements for the type of roasts involved in the outbreaks. 
Published articles have demonstrated that dry heat has a lower 
lethality than moist heat in killing Salmonella.14,15 
Blankenship 16 demonstrated that Salmonella survived on the 
surface of the roast even though an internal temperature of 147.5 
deg.F was attained in a gas-fired oven with no control for humidity. 
Another researcher showed that dry oven temperatures below 250  deg.F 
permitted Salmonella survival on the surface, but that when steam was 
injected for 30 minutes into a 175  deg.F oven, Salmonella was 
eliminated on the surface of the roasts cooked to an internal 
temperature of 130  deg.F or higher.17
---------------------------------------------------------------------------

    \14\ Blankenship, L.C. (1978) Survival of a Salmonella 
typhimurium experimental contaminant during cooking of beef roasts. 
Appl. Environ. Microbiol. 35:1160.
    \15\ Goodfellow, S.J., and Brown, W.L. (1978) Fate of Salmonella 
inoculated into beef for cooking. J. Food Protect. 41-598.
    \16\ Blankenship, L.C.
    \17\ Goodfellow, S.J., and Brown, W.L.
---------------------------------------------------------------------------

    Until 1977, the outbreaks of salmonellosis attributable to 
commercially produced precooked roast beef occurred frequently, 
particularly in the northeast.\18\ In 1977 and 1978, cooking 
requirements for cooked beef and roast beef involving time, 
temperature, and in some cases, relative humidity were established. 
Following the implementation of the cooking requirements, one outbreak 
of

[[Page 742]]

salmonellosis occurred in 1978 due to a deviation from the cooking 
requirements. No further outbreaks were reported until 1981. 
Investigation showed that the 1981 outbreaks of salmonellosis resulted 
from processing procedures unrelated to humidity control. The 
processors either did not use one of the prescribed cooking time/
temperature combinations or failed to maintain good sanitary practices 
(e.g., failed to maintain adequate separation of raw and cooked 
product).\19\
---------------------------------------------------------------------------

    \18\ Centers for Disease Control (1981) Multi state Outbreak of 
Salmonellosis Caused by Precooked Roast Beef. MMWR 30:391-2.
    \19\ Houston, D.L. (1982) Production Requirements for Cooked 
Beef, Roast Beef, and Cooked Corned Beef. FR 47:31854.
---------------------------------------------------------------------------

    Comment: One commenter suggested that FSIS have the same cooking 
standard for roasts weighing less than 10 pounds as for those weighing 
more than 10 pounds.
    Response: FSIS does not agree. Research has been done to determine 
the effect of product size on Salmonella survival on the surface of 
beef roasts. The results of the research showed that beef rounds of 10 
pounds and larger can be dry roasted safely; beef rounds of 5 pounds or 
less cannot be safely dry roasted to the rare state (<135 deg.F or 57.2 
 deg.C internal temperature).\20\
---------------------------------------------------------------------------

    \20\ Goodfellow, S.J., and Brown, W.L. (1978) Fate of Salmonella 
Inoculated Into Beef for Cooking. J. Food Protect. 41:598.
---------------------------------------------------------------------------

Disposition of Products Not Meeting Performance Standards

    Comment: One commenter stated that the disposition of products not 
meeting the performance standards was not addressed in this rule. The 
commenter recommended that as deviations occur, the establishment 
should assess product safety as one activity of corrective action; and 
the establishment may seek the advice of a process authority in this 
regard. This commenter declared that under HACCP, the Agency role in 
assuring product safety is in verification.
    In a comment related to disposition of product produced under 
extreme conditions, a commenter recommended that ``come-up time'' 
during the cooking process be addressed as a performance standard. He 
suggested that the performance standard be less than 10 generations of 
multiplication of Clostridium perfringens when heating product from 50 
deg.F to over 130  deg.F.
    Response: FSIS agrees that the proposal did not include provisions 
for determining the disposition of product that did not meet the 
performance standards. FSIS also agrees that under HACCP, it will be 
the establishment's responsibility to determine the disposition of 
product not meeting performance standards. The Agency realizes that the 
determination of disposition of such a product can often be a vexing 
problem. Most important may be the question of whether or not the 
product can be reprocessed to make it safe for consumption.
    Heating deviations are generally related to the issue of ``come-up 
time.'' Computer modeling as a tool to address problems related to 
excessive time to temperature is somewhat problematic. One of the 
primary difficulties of modeling specific occurrences is that current 
programs only allow modeling under only unfluctuating temperature 
conditions. Currently, the Agency has been using the ARS Pathogen 
Modeling Program Version 4.0 to model growth conditions. Further 
discussion on ``come-up time'' is contained in the attached Compliance 
Guides.
    With respect to addressing cooling deviations, the Agency has been 
using another program that estimates the relative growth of Clostridium 
perfringens and Clostridium botulinum to provide an initial rough 
assessment of the severity of a cooling deviation. In cooperation with 
ARS, efforts are underway to improve this program. In the future, the 
Agency would like to make this program available to the industry and 
will welcome comments towards further advancing its capabilities and 
usefulness.
    Following an initial assessment, some establishments may want to 
sample product to determine whether or not the specific lot of finished 
product meets the performance standard for stabilization. Because of a 
lack of information concerning the distribution of C. perfringens in 
product, sampling may not be the best recourse for determining the 
disposition of product following cooling deviations. After obtaining 
the test results from the samples, the disposition of the product can 
be determined. There are three possibilities: the lot should be 
destroyed; recooking will render the product safe for consumption; or 
the lot is safe for consumption and no reprocessing is necessary.
    Further guidance concerning cooling deviations is available in 
Appendix B, ``Compliance Guidelines for Cooling Heat-Treated Meat and 
Poultry Products (Stabilization).''

Other Issues

    Comment: A commenter pointed out that Staphylococcus aureus was 
incorrectly identified as a spore former.
    Response: FSIS has corrected this error in this document.
    Comment: A commenter stated that the word ``cooked'' is 
inappropriately used throughout this document, arguing that 
``pasteurized'' or ``fully pasteurized'' would be more correct, 
referring to the reduction of vegetative pathogens to a safe level.
    Response: The word ``cooked'' is commonly used and understood; 
``pasteurized'' or ``fully pasteurized'' would be confusing.
    Comment: A commenter contended that the words ``stabilization'' and 
``handling'' are unnecessary. The operator only need describe the 
process, steps, and then limits for process variables at each step to 
control hazards, minimizing risk.
    Response: The term ``stabilization'' is useful in describing the 
performance standard established in this rulemaking and will be 
retained. The handling performance standard is not being finalized, so 
the term ``handling'' does not appear in these regulations.
    Comment: A commenter stated that is not possible to prevent 
germination of spore-forming bacteria after cooking as indicated in the 
proposal; only multiplication can be controlled.
    Response: FSIS agrees; the term ``germination'' has been removed 
from the stabilization performance standard.
    Comment: One of the commenters applauded the Agency's recent 
efforts to extend food safety concerns to the restaurant and 
institutional settings, especially with regards to the shifting of 
resources outside the environment of meat and poultry establishments. 
This commenter also supported and applauded efforts toward broad 
application of FDA's Food Code in these areas.
    Response: Harmonization of regulations and initiatives towards 
HACCP principles with those of FDA and other government bodies has been 
a worthwhile effort. Ultimately, State, local, and municipal 
authorities will be operating under harmonious principles. To this end, 
the Agency has also been involved in working through Association of 
Food and Drug Officials (AFDO) committees to encourage State adoption 
of acceptable uniform standards presented in the Food Code. In 
addition, FSIS has devoted resources to educating the public in food 
safety concerns. Today, it is important that consumers know how to 
safely store and prepare their food, and particularly important that 
they be aware of and follow good sanitary practices in the kitchen.

The Final Rule

    FSIS is adopting the proposal as a final rule, with changes made in 
response to comments and noted above. In summary, the substantive 
changes are:
     The lethality performance standard for all of the ready-
to-eat cooked beef,

[[Page 743]]

roast beef, and cooked corned beef, is a 6.5 log10 reduction 
in Salmonella.
     The lethality performance standard proposed for ready-to-
eat, uncured meat patties is not being finalized. A revised lethality 
standard will be proposed in an upcoming Federal Register publication. 
(Section 318.23 is being amended in this document, however, by 
replacing cooling requirements with stabilization performance standards 
for fully-cooked, partially-cooked, and char-marked meat patties.)
     The lethality performance standards now clarify 
establishment responsibility not only for reducing Salmonella, but also 
for the ``reduction of other pathogens and their toxins or toxic 
metabolites necessary to prevent adulteration,* * * throughout the 
product.''
     The lethality performance standards now explicitly provide 
for the optional use of a combination of controlled, intermediate steps 
to achieve the required lethality throughout ready-to-eat products.
     Establishments may produce ready-to-eat roast beef or 
poultry products using lethalities other than those prescribed in the 
regulations, as long as they demonstrate in a validated process 
schedule that the processes used achieve an equivalent probability that 
no viable Salmonella organisms remain in the finished product.
     The handling performance standards proposed for ready-to-
eat cooked beef, roast beef, and cooked corned beef and for fully 
cooked meat patty and poultry products are not being finalized. The 
handling requirements for ready-to-eat, uncured meat patties are being 
removed from the regulations.
     Establishments will not be required to hold and test 
product.
     The safe harbors will not be retained in the regulations 
as proposed, but instead will be issued as compliance guidelines. 
Establishments following the safe harbor guidelines may use them as 
process schedules; FSIS will consider such process schedules already 
validated as being effective.

Executive Order 12866 and Regulatory Flexibility Act

    This 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.
    This rule allows meat and poultry establishments to employ 
processing methods other than those previously mandated, as long as 
those methods yield products that meet the performance standards set 
forth in this rule. However, FSIS also will allow establishments to 
meet the performance standards by following the previously mandated 
production methods, which are being disseminated in compliance 
guidelines by FSIS as ``safe harbors.'' Therefore, establishments can 
choose to continue using their current methods of processing and 
probably incur no new expenses (or savings or income) as a result of 
this rule.
    As explained above, the safe harbor compliance guidelines for fully 
cooked poultry contain chilling requirements currently contained in 
FSIS Directive 7110.3, since previously there were no regulatory 
chilling requirements for the poultry products covered under 
Sec. 381.150. FSIS has determined, however, that all establishments 
producing cooked poultry products are meeting the chilling requirements 
in FSIS Directive 7110.3. FSIS anticipates, therefore, that 
establishments choosing the safe harbor guidelines for producing fully 
cooked poultry would experience no economic effect, positive or 
negative.
    The rule will have a favorable economic impact on all 
establishments, regardless of size. When an establishment voluntarily 
elects to use a processing method other than one of those contained in 
the safe harbors, it is likely that it expects to receive increased 
revenues, greater than the cost of implementing and validating the 
processing method, as a result. Also, changes made in response to 
comments received on the proposed rule have reduced costs of adopting 
alternative processing methods, providing even greater incentive for 
innovation. The increased flexibility to innovate allowed by the rule 
will encourage competition, which is a benefit to consumers.
    It is difficult to quantify the potential benefits of this rule 
since it is not possible to predict what effect innovations will have 
on revenues to the establishments or on benefits to consumers. Under 
the previous regulations, FSIS required 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. FSIS anticipates that most establishments initially 
taking advantage of the proposed performance standards would develop 
customized process schedules for ready-to-eat poultry products that 
minimize lost yield.
    As an alternative to this rulemaking, FSIS considered merely 
expanding the list of time/temperature combinations previously allowed 
for processing ready-to-eat meat and poultry products, but otherwise 
maintaining the detailed processing requirements. While this option 
would have expanded flexibility in regard to heat treatment, 
establishments still would have been constrained by the remaining 
prescriptive processing requirements, which are inconsistent with the 
principles of HACCP and can impede innovation. FSIS, therefore, has 
chosen an option it believes will both maximize flexibility and 
encourage innovation: establishments may employ innovative or unique 
processing procedures customized to the nature and volume of their 
production, provided they meet the designated performance standards for 
pathogen reduction.

Executive Order 12778

    This rule has been reviewed under Executive Order 12778, Civil 
Justice Reform. States and local jurisdictions are preempted by the 
Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection 
Act (PPIA) from imposing any marking or packaging requirements on 
federally inspected meat and 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 rule is not intended to have retroactive effect.
    Administrative proceedings will not be required before parties may 
file suit in court challenging this 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 rule, if the challenge involves any decision of an FSIS employee 
relating to inspection services provided under the FMIA or the PPIA.

Paperwork Requirements

    In the proposal preceding this final rule, FSIS proposed ``hold and 
test'' requirements for treated product and a handling performance 
standard, both of which would account for some of the estimated 
paperwork burden. In response to comments requesting that FSIS allow 
establishments more flexibility in meeting the proposed

[[Page 744]]

performance standards, FSIS decided not to make final the ``hold and 
test'' and handling requirements. Therefore, the paperwork burden is 
decreased, though not significantly. FSIS has not adjusted the 
estimated paperwork burden. The paperwork and recordkeeping 
requirements in this final rule are approved under OMB control number 
0583-0109.

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 is amended as follows:

PART 301--DEFINITIONS

    1. The authority citation for part 301 is 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 is amended by removing the paragraph designations 
(a) through (yyy) and adding, in alphabetical order, new definitions 
for ``Process authority'' and ``Process schedule,'' 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 part 318.
    Process schedule. A written description of processing procedures, 
consisting of any number of specific, sequential operations directly 
under the control of the establishment employed in the manufacture of a 
specific product, including the control, monitoring, verification, 
validation, and corrective action activities associated with 
production. This definition does not apply to subpart G of part 318.
* * * * *

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

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

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

    4. In Sec. 317.2, paragraph (l) introductory text is revised to 
read as follows:


Sec. 317.2  Labels: definition; required features.

* * * * *
    (1) Safe handling instructions shall be provided for: All meat and 
meat products of cattle, swine, sheep, goat, horse, other equine that 
do not meet the requirements contained in Sec. 318.17, or that have not 
undergone other processing that would render them ready-to-eat; and all 
comminuted meat patties not heat processed in a manner that conforms to 
the time and temperature combinations in the Table for Permitted Heat-
Processing Temperature/Time Combinations For Fully-Cooked Patties in 
Sec. 318.23, except as exempted under paragraph (l)(4) of this section.
* * * * *
    5. The authority citation for part 318 continues to read as 
follows:

    Authority: 7 U.S.C. 138f, 7 U.S.C. 450, 1901-1906; 21 U.S.C. 
601-695; 7 CFR 2.18, 2.53.

    6. Section 318.17 is 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 6.5-log10 reduction of Salmonella or an 
alternative lethality that achieves an equivalent probability that no 
viable Salmonella organisms remain in the finished product, as well as 
the reduction of other pathogens and their toxins or toxic metabolites 
necessary to prevent adulteration, must be demonstrated to be achieved 
throughout the product. The lethality process must include a cooking 
step. Controlled intermediate step(s) applied to raw product may form 
part of the basis for the equivalency.
    (2) Stabilization. There can be no multiplication of toxigenic 
microorganisms such as Clostridium botulinum, and no more than 1-
log10 multiplication of Clostridium perfringens within the 
product.
    (b) For each product produced using a process other than one 
conducted in accordance with the Hazard Analysis and Critical Control 
Point (HACCP) system requirements in part 417 of this chapter, an 
establishment must develop and have on file and 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 
the establishment in order to evaluate and approve the safety and 
efficacy of each process schedule.
    (c) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or 
by challenge studies conducted outside the plant.
    7. Section 318.23 is revised to read as follows:


Sec. 318.23  Heat-processing and stabilization requirements for uncured 
meat patties.

    (a) Definitions. For purposes of this section, the following 
definitions shall apply:
    (1) Patty. A shaped and formed, comminuted, flattened cake of meat 
food product.
    (2) 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.
    (3) Partially-cooked patties. Meat patties that have been heat 
processed for less time or using lower internal temperatures than are 
prescribed by paragraph (b)(1) of this section.
    (4) Char-marked patties. Meat patties that have been marked by a 
heat source and that have been heat processed for less time or using 
lower internal temperatures than are prescribed by paragraph (b)(1) of 
this section.
    (b) Heat-processing procedures for fully-cooked patties. (1) 
Official establishments which manufacture fully-cooked patties shall 
use one of the following heat-processing procedures:

[[Page 745]]



                Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked Patties
----------------------------------------------------------------------------------------------------------------
     Minimum internal temperature at the center of each patty  (Degrees)          Minimum holding time after
-----------------------------------------------------------------------------  required internal temperature is
                                                                                        reached (Time)
                Fahrenheit                           Or centigrade           -----------------------------------
                                                                                   Minutes         Or seconds
----------------------------------------------------------------------------------------------------------------
151......................................  66.1.............................               .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
----------------------------------------------------------------------------------------------------------------

    (2) The official establishment shall measure the holding time and 
temperature of at least one fully-cooked 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 degree F.
    (3) Requirements for handling heating deviations. (i) If for any 
reason a heating 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 FSIS program employee, 
a report of the investigation, the cause of the deviation, and the 
steps taken to prevent recurrence.
    (ii) In addition, in the case of a heating deviation, the official 
establishment may reprocess the affected product, using one of the 
methods in paragraph (b)(1) in this section; use the affected product 
as an ingredient in another product processed to one of the temperature 
and time combinations in paragraph (b)(1) 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 stabilization 
requirements in paragraph (c) of this section.
    (c) Stabilization. (1) Fully cooked, partially cooked, and char-
marked meat patties must be produced using processes ensuring no 
multiplication of toxigenic microorganisms such as Clostridium 
botulinum, and no more than a 1 log10 multiplication of 
Clostridium perfringens, within the product.
    (2) For each meat patty product produced using a stabilization 
process other than one conducted in accordance with the Hazard Analysis 
and Critical Control Point (HACCP) system requirements in part 417 of 
this chapter, 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.
    (3) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or 
by challenge studies conducted outside the plant.
    (4) 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, 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.
    (5) 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.

PART 320--RECORDS, REGISTRATION, AND REPORTS

    8. The authority citation for part 320 is 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) is removed and reserved.


 320.4  [Amended]

    10. In Sec. 320.4, the first sentence is 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 is 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 is amended by removing the paragraph designations 
(b)(1) through (62) and adding, in alphabetical order, within paragraph 
(b), new definitions for ``Process authority'' and ``Process 
schedule,'' to read as follows:


 381.1  Definitions.

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

[[Page 746]]

Sec. 381.125  [Amended]

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


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

    (a) Fully cooked poultry products must be produced using processes 
ensuring that the products meet the following performance standards:
    (1) Lethality. A 7-log10 reduction of Salmonella or an 
alternative lethality that achieves an equivalent probability that no 
viable Salmonella organisms remain in the finished product, as well as 
the reduction of other pathogens and their toxins or toxic metabolites 
necessary to prevent adulteration, must be demonstrated to be achieved 
throughout the product. The lethality process must include a cooking 
step. Controlled intermediate step(s) applied to raw product may form 
part of the basis for the equivalency.
    (2) Stabilization. There can be no multiplication of toxigenic 
microorganisms such as Clostridium botulinum, and no more than a 1 
log10 multiplication of Clostridium perfringens within the 
product.
    (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 Sec. 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 one 
conducted in accordance with the Hazard Analysis and Critical Control 
Point (HACCP) system requirements in part 417 of this chapter, an 
establishment must develop and have on file, available to FSIS, a 
process schedule, as defined in Sec. 381.1(b). 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) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or 
by challenge studies conducted outside the plant.

    Done in Washington, DC: December 29, 1998.
Thomas J. Billy,
Administrator, Food Safety Inspection Service.

    The following are appendices to the preamble of the Final Rule.

    Note: The following appendices will not appear in the Code of 
Federal Regulations.

Appendix A--Compliance Guidelines for Meeting Lethality Performance 
Standards for Certain Meat and Poultry Products

Introduction

    Establishments producing ready-to-eat roast beef, cooked beef 
and corned beef products and certain ready-to-eat poultry products 
are required by FSIS to meet the lethality performance standards for 
the reduction of Salmonella contained in Secs. 318.17(a)(1) and 
381.150(a)(1) of the meat and poultry inspection regulations. 
Further, FSIS requires meat and poultry establishments, if they are 
not operating under a HACCP plan, to demonstrate how their processes 
meet these lethality performance standards within a written process 
schedule validated for efficacy by a process authority 
(Secs. 318.17(2)(b)and (c) and 381.150 (2)(c) and (d)).
    To assist establishments in meeting the lethality requirements, 
FSIS is issuing these compliance guidelines, which are based upon 
the time/temperature requirements contained in previous regulations. 
Establishments may choose to employ these guidelines as their 
process schedules. FSIS considers these guidelines, if followed 
precisely, to be validated process schedules, since they contain 
processing methods already accepted by the Agency as effective.
    Also within these guidelines, FSIS has provided discussion 
regarding disposition of product following heating deviations and 
advice for the development of customized procedures for meeting the 
lethality performance standards.

Guidelines for Cooked Beef, Roast Beef, and Cooked Corned Beef

    1. Cooked beef and roast beef, including sectioned and formed 
roasts, chunked and formed roasts, and cooked corned beef can be 
prepared using one of the following time and temperature 
combinations to meet either a 6.5-log10 or 7-
log10 reduction of Salmonella. The stated temperature is 
the minimum that must be achieved and maintained in all parts of 
each piece of meat for at least the stated time.

----------------------------------------------------------------------------------------------------------------
                 Minimum internal temperature                    Minimum processing time in minutes or seconds
--------------------------------------------------------------        after minimum temperature is reached
                                                              --------------------------------------------------
         Degrees fahrenheit              Degrees centigrade       6.5-log10 lethality       7-log10 lethality
----------------------------------------------------------------------------------------------------------------
130.................................  54.4...................  112 min.................  121 min.
131.................................  55.0...................  89 min..................  97 min.
132.................................  55.6...................  71 min..................  77 min.
133.................................  56.1...................  56 min..................  62 min.
134.................................  56.7...................  45 min..................  47 min.
135.................................  57.2...................  36 min..................  37 min.
136.................................  57.8...................  28 min..................  32 min.
137.................................  58.4...................  23 min..................  24 min.
138.................................  58.9...................  18 min..................  19 min.
139.................................  59.5...................  15 min..................  15 min.
140.................................  60.0...................  12 min..................  12 min.
141.................................  60.6...................  9 min...................  10 min.
142.................................  61.1...................  8 min...................  8 min.
143.................................  61.7...................  6 min...................  6 min.
144.................................  62.2...................  5 min...................  5 min.
145.................................  62.8...................  4 min...................  4 min.*
146.................................  63.3...................  169 sec.................  182 sec.

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147.................................  63.9...................  134 sec.................  144 sec.
148.................................  64.4...................  107 sec.................  115 sec.
149.................................  65.0...................  85 sec..................  91 sec.
150.................................  65.6...................  67 sec..................  72 sec.
151.................................  66.1...................  54 sec..................  58 sec.
152.................................  66.7...................  43 sec..................  46 sec.
153.................................  67.2...................  34 sec..................  37 sec.
154.................................  67.8...................  27 sec..................  29 sec.
155.................................  68.3...................  22 sec..................  23 sec.
156.................................  68.9...................  17 sec..................  19 sec.
157.................................  69.4...................  14 sec..................  15 sec.
158.................................  70.0...................  11 sec..................  12 sec.
159.................................  70.6...................  10 sec..................  10 sec.
160.................................  71.1...................  10 sec..................  10 sec.
----------------------------------------------------------------------------------------------------------------
* Past regulations have listed the minimum processing time for roast beef cooked to 145 deg. F as ``Instantly.''
  However, due to their large size, most of these roasts dwell at 145 deg. F, or even at higher temperatures,
  for at least 4 minutes after the minimum internal temperature is reached.

    2. Cooked beef, including sectioned and formed roasts and 
chunked and formed roasts, and cooked corned beef should be moist 
cooked throughout the process or, in the case of roast beef or 
corned beef to be roasted, cooked as in paragraph (3) of this 
compliance guide. The moist cooking may be accomplished by placing 
the meat in a sealed, moisture impermeable bag, removing the excess 
air, and cooking; by completely immersing the meat, unbagged in 
water throughout the entire cooking process; or by 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 can be cooked by one 
of the following methods:
     Heating roasts of 10 pounds or more in an oven 
maintained at 250  deg.F (121  deg.C) or higher throughout a process 
achieving one of the time/temperature combinations in (1) above;
     Heating roasts of any size to a minimum internal 
temperature of 145  deg.F (62.8  deg.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
     Heating roasts of any size in an oven maintained at any 
temperature that will satisfy the internal temperature and time 
combinations of the above chart of this compliance guide 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. The relative humidity may be achieved by use of 
steam injection or sealed ovens capable of producing and maintaining 
the required relative humidity.
    4. Establishments producing cooked beef, roast beef, or cooked 
corned beef should have sufficient monitoring equipment, including 
recording devices, to assure that the time (accuracy assured within 
1 minute), the temperature (accuracy assured within 1  deg.F), and 
relative humidity (accuracy assured within 5 percent) limits of 
these processes are being met. Data from the recording devices 
should be made available to FSIS program employees upon request.

Guidelines for Cooked Poultry Rolls and Other Cooked Poultry 
Products

    1. Cooked poultry rolls and other cooked poultry products should 
reach an internal temperature of at least 160  deg.F prior to being 
removed from the cooking medium, except that cured and smoked 
poultry rolls and other cured and smoked poultry should reach an 
internal temperature of at least 155  deg.F prior to being removed 
from the cooking medium. Cooked ready-to-eat product to which heat 
will be applied incidental to a subsequent processing procedure may 
be removed from the media for such processing provided that it is 
immediately fully cooked to the 160  deg.F internal temperature.
    2. Establishments producing cooked poultry rolls and other 
cooked poultry products should have sufficient monitoring equipment, 
including recording devices, to assure that the temperature 
(accuracy assured within 1  deg.F) limits of these processes are 
being met. Data from the recording devices should be made available 
to FSIS program employees upon request.

Discussion

Heating Deviations and Slow Come Up Time

    Determining the appropriate disposition of products following 
heating deviations can be even more difficult than determining the 
disposition of product after a cooling deviation. Heating 
deviations, which most often involve slow come-up time or an 
inordinate dwell time within the optimum temperature range for 
microorganism growth, can foster the multiplication of many 
pathogens. This multiplication sometimes can be so prodigious that 
even recooking may be ineffective in rendering the product safe. 
Also, certain toxigenic bacteria can release toxins into the 
product. Some of these toxins, such as those of Staphylococcus 
aureus, are extremely heat stable and are not inactivated by normal 
recooking temperatures.
    Further, the sampling of product following a heating deviation 
may not yield sufficient information to determine the safety of the 
product in question. Heating deviations can favor the multiplication 
of many types of bacteria. It would be difficult and expensive to 
sample for all of them.
    Depending on the circumstances, establishments may want to use 
computer modeling to estimate the relative multiplication of 
bacteria. For example, in a past incident involving an extreme 
heating deviation, product was put in an oven in which the 
temperature was inadvertently set to 95 deg.F for about 12 hours. 
Computer modeling was easily applied in this case because much of 
the dwell time was at one temperature. The Agency determined that 
within a 6 hour time frame (with other growth conditions assumed to 
be favorable), the relative multiplication of many pathogens of 
concern could have exceeded five logs. Clearly the product could not 
be salvaged by reprocessing and was therefore destroyed.
    Under changing conditions of temperature, however, computer 
modeling becomes more difficult. One approach is to average lag/log 
times over small increments such as 5 deg. and add these times to 
get an approximation of possible total relative growth over a larger 
increment of time. Establishments must keep in mind that the 
population of bacteria before processing is generally unknown and 
that assumptions in the high range often are used as input 
parameters in the modeling.
    Establishments should ultimately rely upon the expertise of a 
processing authority to determine the severity of heating deviations 
and subsequent appropriate disposition of the product in question. 
Dwell times of greater than 6 hours in the 50 deg.F to 130 deg.F 
range should be viewed as especially hazardous, as this temperature 
range can foster substantial growth of many pathogens of concern. 
And, a knowledge of the specific product and factors that would 
favor or

[[Page 748]]

inhibit the growth of various bacteria is essential.

Computer Modeling Program Availability

    The Microbial Food Safety Research Unit of the Eastern Regional 
Research Center, USDA Agriculture Research Service, has developed a 
bacterial pathogen modeling program. Entitled ``Pathogen Modeling 
Program-Version 5.1 for Windows,'' it is available on the Internet 
from http://www.arserrc.gov. Other programs may be available 
commercially.

Customized Processes

    Although compliance with these guidelines will yield product 
that meets the lethality performance standards, some establishments 
may want to develop customized processing procedures that meet the 
codified lethality performance standards: 6.5 10 log of 
Salmonella in ready-to-eat beef products and 7 log 10 in 
ready-to-eat poultry products. Establishments also may want to 
develop and implement processes using alternative lethalities. Keep 
in mind, however, that all processes also must achieve, throughout 
the product, an appropriate reduction of other pathogens of concern 
and their toxins or toxic metabolites.
    Establishments or their process authorities may develop 
customized procedures or alternative lethalities that meet the 
performance standards by using information obtained from the 
literature and/or by comparing their methods with established 
processes. However, statistical calculations on results obtained 
from sampling alone are not sufficient to demonstrate that product 
satisfies reduced initial product conditions or that product meets 
the performance standards. Rather, the demonstration should be based 
on scientific rationale, supported by experimental data.
    One of the most definitive tools at the disposal of an 
establishment or processing authority is the challenge study. 
Although challenge studies must be conducted in the laboratory 
rather than the establishment, they should be designed and conducted 
to accurately simulate the commercial process. Challenge studies 
should be undertaken by individuals who have a thorough knowledge of 
laboratory methods used in salmonellae research. A cocktail of 
various serotypes of Salmonella should be used in an inoculated pack 
study to demonstrate that the lethality performance standard is met. 
Relatively heat resistant pathogenic strains should be included in 
the cocktail to develop a worst case. The serotypes/strains selected 
should be among those that have been historically implicated in an 
appreciable number of outbreaks.

Appendix B--Compliance Guidelines for Cooling Heat-Treated Meat and 
Poultry Products (Stabilization)

Introduction

    Establishments producing ready-to-eat roast beef, cooked beef 
and corned beef products, fully cooked, partially cooked, and char-
marked meat patties, and certain partially cooked and ready-to-eat 
poultry products are required by FSIS to meet the stabilization 
performance standards for preventing the growth of spore-forming 
bacteria (Secs. 318.17(a)(2), 318.23(d)(1), and 381.150(a)(2), 
respectively). Further, FSIS requires meat and poultry 
establishments, if they are not operating under a HACCP plan, to 
demonstrate how their processes meet these stabilization performance 
standards within a written process schedule validated for efficacy 
by a process authority (Secs. 318.17(b) and (c); 318.23(d)(2) and 
(3); and 381.150(c) and (d)).
    To assist establishments in meeting the stabilization 
requirements, FSIS is issuing these compliance guidelines, which are 
based upon FSIS Directives and the product cooling requirements 
contained in previous regulations. Establishments may choose to 
employ these guidelines as their process schedules. FSIS considers 
these guidelines, if followed precisely, to be validated process 
schedules, since they contain processing methods already accepted by 
the Agency as effective.
    Also within these guidelines, FSIS has provided discussion 
regarding disposition of product following cooling deviations and 
advice for the development of customized procedures for meeting the 
stabilization performance standards.

Stabilization Guidelines

    It is very important that cooling be continuous through the 
given time/temperature control points. Excessive dwell time in the 
range of 130 deg. to 80 deg.F is especially hazardous, as this is 
the range of most rapid growth for the clostridia. Therefore cooling 
between these temperature control points should be as rapid as 
possible.
    1. During cooling, the product's maximum internal temperature 
should not remain between 130  deg.F and 80  deg.F for more than 1.5 
hours nor between 80  deg.F and 40  deg.F for more than 5 hours. 
This cooling rate can be applied universally to the products and is 
preferable to (2) below.
    2. Product consisting of pieces of intact muscle, such as beef, 
turkey breast or pork loin, may be cooled as follows: Chilling 
should begin within 90 minutes after the cooking cycle is completed. 
All product should be chilled from 120 deg.F (48 deg.C) to 55 deg.F 
(12.7 deg.C) in no more than 6 hours. Chilling should then continue 
and the product not packed for shipment before it has reached 
40 deg.F (4.4 deg.C)
    This cooling guideline was derived from the former (``Roast Beef 
Regulation'', 9 CFR 318.17(h)(10)), which originally applied to 
cooked beef, cooked corned beef, and cooked roast beef. However, if 
this cooling rate is used as a guideline it remains important that 
cooling be rapid between 130 deg.F and 80 deg.F.

Discussion

Cooling Deviations

    In spite of the best efforts of an establishment to maintain 
process control, cooling deviations will occasionally occur. Power 
failures or breakdowns of refrigeration equipment cause situations 
that cannot always be anticipated. However, it is important that the 
establishment plan how to cope with such eventualities before they 
occur.
    The recommended time/temperature combinations in these 
guidelines incorporate a small safety margin. Therefore, an 
occasional small lapse in and of itself may not cause a problem in 
every instance. If the cause of a small cooling deviation is not 
traced and corrected when first noticed, however, the problem will 
likely recur and possibly become more frequent and more severe. The 
processor should consider an occasional small deviation an 
opportunity to find and correct a control problem. Of course, a 
large deviation or continual small ones will always constitute 
unacceptable risk.
    After it is determined that a cooling deviation has occurred, 
the processor should:
    1. Notify the inspector, the QC unit, and other concerned units, 
such as refrigeration maintenance and production.
    2. Hold the involved product and determine the potential 
adulteration by bacteria, particularly clostridial pathogens. If 
adulteration is confirmed or appears to be likely, inform the 
inspector.
    3. Postpone further product manufacturing using that chill 
facility until the processor has:
    a. determined the cause of the deviation;
    b. completed adjustments to assure that the deviation will not 
recur; and
    c. informed the inspector and the production units of the 
determinations and adjustments and make any needed amendments in the 
written processing procedures.

Computer Modeling and Sampling

    In the event that a cooling deviation does occur, the product 
may often be salvaged if the results of computer modeling and/or 
sampling can ensure product safety. Because of a lack of information 
concerning the distribution of C. perfringens in product, sampling 
may not be the best recourse for determining the disposition of 
product following cooling deviations. However, computer modeling can 
be a useful tool in assessing the severity of a cooling deviation. 
While computer modeling cannot provide an exact determination of the 
possible amount clostridial growth, it can provide a useful 
estimate.
    A technical document (available from the FSIS Docket Room 
1) provides description of the calculations that are used 
to estimate relative growth.
---------------------------------------------------------------------------

    \1\ FSIS Docket Room, U.S. Department of Agriculture, Room 102, 
Cotton Annex, 300 12th St. SW, Washington, DC 20250-3700.
---------------------------------------------------------------------------

    With careful continuous monitoring of the heating and cooling 
time/temperature profile of each lot, there will always be many 
available data points, enhancing the accuracy of computer modeling. 
Conversely, when there are few documented time/temperature data 
points, the accuracy of the modeling decreases markedly. If time/
temperature monitoring has not been conducted through the end point 
internal product temperatures of 40 deg. F or less, sampling is not 
an option and the product should be destroyed.

Options after computer determination of cooling deviation severity

    If computer modeling suggests that the cooling deviation would 
likely result in more than one log increase in Clostridium 
perfringens, without any multiplication

[[Page 749]]

(remains in lag phase) of Clostridium botulinum, then the 
establishment can choose to recook or sample the product.
    Recook only when:
     All product was either immediately refrigerated after 
the deviation or can be immediately recooked after the deviation; 
and
     The recooking procedure can achieve a final internal 
product temperature of at least 149  deg.F (65  deg.C) for two 
minutes. Subsequent to recooking, the product must be cooled in 
strict conformance to existing guidelines. When the product is to be 
reworked with another raw product, the recooking procedure for the 
combined product must achieve a minimum internal temperature of 149 
deg.F, to address the cooling deviation, and further to an increased 
time/temperature if necessary to be in accord with any other 
requirement relative to microbiological safety for the intended 
final product. Subsequent to recooking, the product must be cooled 
in strict conformance to existing guidelines.

Custom Stabilization Processes

    While compliance with the guidelines above will yield product 
that meets the cooling performance standards, some establishments 
may want to develop customized stabilization procedures. Because 
customized process schedules must be validated by process 
authorities for efficacy, most establishments will probably rely 
upon processing authorities to develop such procedures, demonstrate 
their efficacy, and attest to their safety. Process authorities may 
obtain information from the literature, or likely compare peer 
reviewed methods in determining safe procedures that meet the 
performance standards.
    Probably one of the most definitive tools at the disposal of the 
processing authority is the inoculated pack study. Such studies 
should, of course, be conducted only in the laboratory, not in the 
plant. Further, such studies should be undertaken by individuals who 
have a thorough knowledge of laboratory methods used in clostridial 
research. Clostridium perfringens can be used alone in an inoculated 
pack study to demonstrate that the cooling performance standard is 
met for both microorganisms, Clostridium perfringens, and 
Clostridium botulinum. This is because conditions of time/
temperature that would limit the growth of Clostridium perfringens 
to one log or less would also prevent multiplication of Clostridium 
botulinum, which is much slower. A cocktail of various strains of 
Clostridium perfringens spores is often used for this purpose. 
Relatively ``fast'' toxigenic strains should be used to develop a 
worst case. However, the strains selected should be among those that 
have been historically implicated in an appreciable number of 
outbreaks, especially in products similar to those being prepared in 
the establishment.

[FR Doc. 99-32 Filed 1-5-99; 8:45 am]
BILLING CODE 3410-DM-P