[Federal Register: January 6, 1999 (Volume 64, Number 3)]

[Rules and Regulations]               

[Page 732-749]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr06ja99-2]





[[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 10x . In terms of probability 

distributions, this means that the probability, p, that a given 

organism will survive a ``x-log10'' lethality reduction is p 

= (1/10x.)\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 

104 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 105 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 106 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 104 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 104 Clostridium perfringens (spores) per gram on raw 

product, it is possible that there could be as many as 104 

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 105 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:

    <bullet> 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.

    <bullet> 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.)

    <bullet> 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.''

    <bullet> 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.

    <bullet> 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.

    <bullet> 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.

    <bullet> Establishments will not be required to hold and test 

product.

    <bullet> 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.



 

[FR Doc. 99-32 Filed 1-5-99; 8:45 am]

BILLING CODE 3410-DM-P