Federal Register, Volume 64 Issue 3 (Wednesday, January 6, 1999)

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

[[Page 732]]

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

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.

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

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

EFFECTIVE DATES: March 8, 1999.

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

SUPPLEMENTARY INFORMATION:

Background

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

Ready-to-Eat Products

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

Lethality

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

\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.
---------------------------------------------------------------------------

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)).
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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.''
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

\6\ Surkiewicz, B.F., et al. (1975) Bacteriological Survey of
Raw Beef Patties Produced at Establishments under Federal
Inspection, Applied Microbiology, p. 331-334.
---------------------------------------------------------------------------

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

[[Page 737]]

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

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

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

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

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

[[Page 738]]

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

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

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

Stabilization

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

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

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

[[Page 739]]

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

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

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

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

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

Handling

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

[[Page 740]]

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

Process Authority

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

Testing and Other Validation Activities

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

Safe Harbors and Performance Standards

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

[[Page 741]]

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

Recommended Amendments to Specific Safe Harbors

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

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

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

[[Page 742]]

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

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

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

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

Disposition of Products Not Meeting Performance Standards

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

Other Issues

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

The Final Rule

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

[[Page 743]]

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

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
This rule allows meat and poultry establishments to employ
processing methods other than those previously mandated, as long as
those methods yield products that meet the performance standards set
forth in this rule. However, FSIS also will allow establishments to
meet the performance standards by following the previously mandated
production methods, which are being disseminated in compliance
guidelines by FSIS as ``safe harbors.'' Therefore, establishments can
choose to continue using their current methods of processing and
probably incur no new expenses (or savings or income) as a result of
this rule.
As explained above, the safe harbor compliance guidelines for fully
cooked poultry contain chilling requirements currently contained in
FSIS Directive 7110.3, since previously there were no regulatory
chilling requirements for the poultry products covered under
Sec. 381.150. FSIS has determined, however, that all establishments
producing cooked poultry products are meeting the chilling requirements
in FSIS Directive 7110.3. FSIS anticipates, therefore, that
establishments choosing the safe harbor guidelines for producing fully
cooked poultry would experience no economic effect, positive or
negative.
The rule will have a favorable economic impact on all
establishments, regardless of size. When an establishment voluntarily
elects to use a processing method other than one of those contained in
the safe harbors, it is likely that it expects to receive increased
revenues, greater than the cost of implementing and validating the
processing method, as a result. Also, changes made in response to
comments received on the proposed rule have reduced costs of adopting
alternative processing methods, providing even greater incentive for
innovation. The increased flexibility to innovate allowed by the rule
will encourage competition, which is a benefit to consumers.
It is difficult to quantify the potential benefits of this rule
since it is not possible to predict what effect innovations will have
on revenues to the establishments or on benefits to consumers. Under
the previous regulations, FSIS required that ready-to-eat poultry
products reach specific, minimum internal temperatures before being
removed from a cooking medium. The products lose water during cooking
at these temperatures and consequently, establishments must add water
and other ingredients both to make the products palatable and to
restore lost yield. FSIS anticipates that most establishments initially
taking advantage of the proposed performance standards would develop
customized process schedules for ready-to-eat poultry products that
minimize lost yield.
As an alternative to this rulemaking, FSIS considered merely
expanding the list of time/temperature combinations previously allowed
for processing ready-to-eat meat and poultry products, but otherwise
maintaining the detailed processing requirements. While this option
would have expanded flexibility in regard to heat treatment,
establishments still would have been constrained by the remaining
prescriptive processing requirements, which are inconsistent with the
principles of HACCP and can impede innovation. FSIS, therefore, has
chosen an option it believes will both maximize flexibility and
encourage innovation: establishments may employ innovative or unique
processing procedures customized to the nature and volume of their
production, provided they meet the designated performance standards for
pathogen reduction.

Executive Order 12778

This rule has been reviewed under Executive Order 12778, Civil
Justice Reform. States and local jurisdictions are preempted by the
Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection
Act (PPIA) from imposing any marking or packaging requirements on
federally inspected meat and poultry products that are in addition to,
or different than, those imposed under the FMIA or the PPIA. States and
local jurisdictions may, however, exercise concurrent jurisdiction over
meat and poultry products that are outside official establishments for
the purpose of preventing the distribution of meat and poultry products
that are misbranded or adulterated under the FMIA or PPIA, or, in the
case of imported articles, which are not at such an establishment,
after their entry into the United States.
This rule is not intended to have retroactive effect.
Administrative proceedings will not be required before parties may
file suit in court challenging this rule. However, the administrative
procedures specified in 9 CFR Secs. 306.5 and 381.35 must be exhausted
prior to any judicial challenge of the application of the provisions of
this rule, if the challenge involves any decision of an FSIS employee
relating to inspection services provided under the FMIA or the PPIA.

Paperwork Requirements

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

[[Page 744]]

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

List of Subjects

9 CFR Part 301

Meat inspection.

9 CFR Part 317

Food labeling.

9 CFR Part 318

Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 320

Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 381

Poultry and poultry products inspection, Reporting and
recordkeeping requirements.

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

PART 301--DEFINITIONS

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

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

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

Sec. 301.2 Definitions.

* * * * *
Process authority. A person or organization with expert knowledge
in meat production process control and relevant regulations. This
definition does not apply to subpart G of part 318.
Process schedule. A written description of processing procedures,
consisting of any number of specific, sequential operations directly
under the control of the establishment employed in the manufacture of a
specific product, including the control, monitoring, verification,
validation, and corrective action activities associated with
production. This definition does not apply to subpart G of part 318.
* * * * *

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

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

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

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

Sec. 317.2 Labels: definition; required features.

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

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

6. Section 318.17 is revised to read as follows:

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

(a) Cooked beef, roast beef, and cooked corned beef products must
be produced using processes ensuring that the products meet the
following performance standards:
(1) Lethality. A 6.5-log10 reduction of Salmonella or an
alternative lethality that achieves an equivalent probability that no
viable Salmonella organisms remain in the finished product, as well as
the reduction of other pathogens and their toxins or toxic metabolites
necessary to prevent adulteration, must be demonstrated to be achieved
throughout the product. The lethality process must include a cooking
step. Controlled intermediate step(s) applied to raw product may form
part of the basis for the equivalency.
(2) Stabilization. There can be no multiplication of toxigenic
microorganisms such as Clostridium botulinum, and no more than 1-
log10 multiplication of Clostridium perfringens within the
product.
(b) For each product produced using a process other than one
conducted in accordance with the Hazard Analysis and Critical Control
Point (HACCP) system requirements in part 417 of this chapter, an
establishment must develop and have on file and available to FSIS, a
process schedule, as defined in Sec. 301.2 of this chapter. Each
process schedule must be approved in writing by a process authority for
safety and efficacy in meeting the performance standards established
for the product in question. A process authority must have access to
the establishment in order to evaluate and approve the safety and
efficacy of each process schedule.
(c) Under the auspices of a processing authority, an establishment
must validate new or altered process schedules by scientifically
supportable means, such as information gleaned from the literature or
by challenge studies conducted outside the plant.
7. Section 318.23 is revised to read as follows:

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

(a) Definitions. For purposes of this section, the following
definitions shall apply:
(1) Patty. A shaped and formed, comminuted, flattened cake of meat
food product.
(2) Comminuted. A processing term describing the reduction in size
of pieces of meat, including chopping, flaking, grinding, or mincing,
but not including chunking or sectioning.
(3) Partially-cooked patties. Meat patties that have been heat
processed for less time or using lower internal temperatures than are
prescribed by paragraph (b)(1) of this section.
(4) Char-marked patties. Meat patties that have been marked by a
heat source and that have been heat processed for less time or using
lower internal temperatures than are prescribed by paragraph (b)(1) of
this section.
(b) Heat-processing procedures for fully-cooked patties. (1)
Official establishments which manufacture fully-cooked patties shall
use one of the following heat-processing procedures:

[[Page 745]]

Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked Patties
----------------------------------------------------------------------------------------------------------------
Minimum internal temperature at the center of each patty (Degrees) Minimum holding time after
----------------------------------------------------------------------------- required internal temperature is
reached (Time)
Fahrenheit Or centigrade -----------------------------------
Minutes Or seconds
----------------------------------------------------------------------------------------------------------------
151...................................... 66.1............................. .68 41
152...................................... 66.7............................. .54 32
153...................................... 67.2............................. .43 26
154...................................... 67.8............................. .34 20
155...................................... 68.3............................. .27 16
156...................................... 68.9............................. .22 13
157 (and up)............................. 69.4 (and up).................... .17 10
----------------------------------------------------------------------------------------------------------------

(2) The official establishment shall measure the holding time and
temperature of at least one fully-cooked patty from each production
line each hour of production to assure control of the heat process. The
temperature measuring device shall be accurate within 1 degree F.
(3) Requirements for handling heating deviations. (i) If for any
reason a heating deviation has occurred, the official establishment
shall investigate and identify the cause; take steps to assure that the
deviation will not recur; and place on file in the official
establishment, available to any duly authorized FSIS program employee,
a report of the investigation, the cause of the deviation, and the
steps taken to prevent recurrence.
(ii) In addition, in the case of a heating deviation, the official
establishment may reprocess the affected product, using one of the
methods in paragraph (b)(1) in this section; use the affected product
as an ingredient in another product processed to one of the temperature
and time combinations in paragraph (b)(1) in this section, provided
this does not violate the final product's standard of composition,
upset the order of predominance of ingredients, or perceptibly affect
the normal product characteristics; or relabel the affected product as
a partially-cooked patty product, if it meets the stabilization
requirements in paragraph (c) of this section.
(c) Stabilization. (1) Fully cooked, partially cooked, and char-
marked meat patties must be produced using processes ensuring no
multiplication of toxigenic microorganisms such as Clostridium
botulinum, and no more than a 1 log10 multiplication of
Clostridium perfringens, within the product.
(2) For each meat patty product produced using a stabilization
process other than one conducted in accordance with the Hazard Analysis
and Critical Control Point (HACCP) system requirements in part 417 of
this chapter, an establishment must develop and have on file, available
to FSIS, a process schedule, as defined in Sec. 301.2 of this chapter.
Each process schedule must be approved in writing by a process
authority for safety and efficacy in meeting the performance standards
established for the product in question. A process authority must have
access to an establishment in order to evaluate and approve the safety
and efficacy of each process schedule.
(3) Under the auspices of a processing authority, an establishment
must validate new or altered process schedules by scientifically
supportable means, such as information gleaned from the literature or
by challenge studies conducted outside the plant.
(4) Partially cooked patties must bear the labeling statement
``Partially cooked: For Safety Cook Until Well Done (Internal Meat
Temperature 160 degrees F.).'' The labeling statement must be adjacent
to the product name, and prominently placed with such conspicuousness
(as compared with other words, statements, designs or devices in the
labeling) as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
(5) Char-marked patties must bear the labeling statement
``Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal
Meat Temperature 160 degrees F.).'' The labeling statement shall be
adjacent to the product name, at least one-half the size of the largest
letter in the product name, and prominently placed with such
conspicuousness (as compared with other words, statements, designs or
devices in the labeling) as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.

PART 320--RECORDS, REGISTRATION, AND REPORTS

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

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

Sec. 320.1 [Amended]

9. In Sec. 320.1, paragraph (b)(4) is removed and reserved.

320.4 [Amended]

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

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

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

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

12. Section 381.1 is amended by removing the paragraph designations
(b)(1) through (62) and adding, in alphabetical order, within paragraph
(b), new definitions for ``Process authority'' and ``Process
schedule,'' to read as follows:

381.1 Definitions.

* * * * *
(b) * * *
Process authority. A person or organization with expert knowledge
in poultry production process control and relevant regulations.
Process schedule. A written description of processing procedures,
consisting of any number of specific, distinct, and ordered operations
directly under control of the establishment employed in the manufacture
of a specific product, including the control, monitoring, verification,
validation, and corrective action activities associated with
production.
* * * * *

[[Page 746]]

Sec. 381.125 [Amended]

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

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

(a) Fully cooked poultry products must be produced using processes
ensuring that the products meet the following performance standards:
(1) Lethality. A 7-log10 reduction of Salmonella or an
alternative lethality that achieves an equivalent probability that no
viable Salmonella organisms remain in the finished product, as well as
the reduction of other pathogens and their toxins or toxic metabolites
necessary to prevent adulteration, must be demonstrated to be achieved
throughout the product. The lethality process must include a cooking
step. Controlled intermediate step(s) applied to raw product may form
part of the basis for the equivalency.
(2) Stabilization. There can be no multiplication of toxigenic
microorganisms such as Clostridium botulinum, and no more than a 1
log10 multiplication of Clostridium perfringens within the
product.
(b) Partially cooked poultry breakfast strips must be produced
using processes ensuring that the products meet the performance
standard listed in paragraph (a)(2) of this section. Labeling for these
products must comply with Sec. 381.125. In addition, the statement
``Partially Cooked: For Safety, Cook Until Well Done'' must appear on
the principal display panel in letters no smaller than \1/2\ the size
of the largest letter in the product name. Detailed cooking
instructions shall be provided on the immediate container of the
products.
(c) For each product produced using a process other than one
conducted in accordance with the Hazard Analysis and Critical Control
Point (HACCP) system requirements in part 417 of this chapter, an
establishment must develop and have on file, available to FSIS, a
process schedule, as defined in Sec. 381.1(b). Each process schedule
must be approved in writing by a process authority for safety and
efficacy in meeting the performance standards established for the
product in question. A process authority must have access to an
establishment in order to evaluate and approve the safety and efficacy
of each process schedule.
(d) Under the auspices of a processing authority, an establishment
must validate new or altered process schedules by scientifically
supportable means, such as information gleaned from the literature or
by challenge studies conducted outside the plant.

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

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

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

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

Introduction

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

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

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

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

[[Page 747]]

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

2. Cooked beef, including sectioned and formed roasts and
chunked and formed roasts, and cooked corned beef should be moist
cooked throughout the process or, in the case of roast beef or
corned beef to be roasted, cooked as in paragraph (3) of this
compliance guide. The moist cooking may be accomplished by placing
the meat in a sealed, moisture impermeable bag, removing the excess
air, and cooking; by completely immersing the meat, unbagged in
water throughout the entire cooking process; or by using a sealed
oven or steam injection to raise the relative humidity above 90
percent throughout the cooking process.
3. Roast beef or corned beef to be roasted can be cooked by one
of the following methods:
Heating roasts of 10 pounds or more in an oven
maintained at 250 deg.F (121 deg.C) or higher throughout a process
achieving one of the time/temperature combinations in (1) above;
Heating roasts of any size to a minimum internal
temperature of 145 deg.F (62.8 deg.C) in an oven maintained at any
temperature if the relative humidity of the oven is maintained
either by continuously introducing steam for 50 percent of the
cooking time or by use of a sealed oven for over 50 percent of the
cooking time, or if the relative humidity of the oven is maintained
at 90 percent or above for at least 25 percent of the total cooking
time, but in no case less than 1 hour; or
Heating roasts of any size in an oven maintained at any
temperature that will satisfy the internal temperature and time
combinations of the above chart of this compliance guide if the
relative humidity of the oven is maintained at 90 percent or above
for at least 25 percent of the total cooking time, but in no case
less than 1 hour. The relative humidity may be achieved by use of
steam injection or sealed ovens capable of producing and maintaining
the required relative humidity.
4. Establishments producing cooked beef, roast beef, or cooked
corned beef should have sufficient monitoring equipment, including
recording devices, to assure that the time (accuracy assured within
1 minute), the temperature (accuracy assured within 1 deg.F), and
relative humidity (accuracy assured within 5 percent) limits of
these processes are being met. Data from the recording devices
should be made available to FSIS program employees upon request.

Guidelines for Cooked Poultry Rolls and Other Cooked Poultry
Products

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

Discussion

Heating Deviations and Slow Come Up Time

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

[[Page 748]]

inhibit the growth of various bacteria is essential.

Computer Modeling Program Availability

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

Customized Processes

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

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

Introduction

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

Stabilization Guidelines

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

Discussion

Cooling Deviations

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

Computer Modeling and Sampling

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

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

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

Options after computer determination of cooling deviation severity

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

[[Page 749]]

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

Custom Stabilization Processes

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

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