[Federal Register Volume 61, Number 86 (Thursday, May 2, 1996)]
[Proposed Rules]
[Pages 19564-19578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10796]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed
Rules
[[Page 19564]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 317, 318, 320, and 381
[Docket No. 95-033P]
Performance Standards for the Production of Certain Meat and
Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat and poultry inspection regulations by converting
the current regulations governing the production of cooked beef
products, uncured meat patties, and certain poultry products into
performance standards. The proposed performance standards spell out the
objective level of performance establishments must meet during their
operations in order to produce safe products, but allow the use of
plant-specific processing procedures other than the procedures
prescribed in the current regulations.
Performance standards set forth requirements in terms of what is to
be achieved by a given regulatory requirement. They represent a shift
in focus from ``command-and-control'' regulations in that they specify
the ends to be achieved (producing safe meat and poultry products), but
not the means to achieve those ends. The command-and-control provisions
in the current regulations prescribe the means for producing safe meat
and poultry products, specifying step-by-step procedures to be followed
by establishments.
All of the command-and-control provisions in the current
regulations meet the proposed performance standards. FSIS proposes to
maintain the current provisions in the regulations as examples of how
an establishment might comply with the proposed performance standards
(``safe harbors''). Therefore, establishments would not be required to
change any current practices in response to this proposed rule.
The specific categories of products affected follow: cooked beef,
roast beef, and cooked corned beef; fully cooked, partially cooked, and
char-marked uncured meat patties; and certain fully and partially
cooked poultry products. Any establishment producing these products and
choosing to develop and use procedures different from those provided in
the safe-harbor example would be required to maintain on file a
documented process schedule that has been approved by a process
authority for safety and efficacy, as required by the performance
standard. The process schedule would include control, monitoring,
validation, and corrective action activities to be performed by the
establishment.
DATES: Comments must be received on or before July 1, 1996.
ADDRESSES: Submit one original and two copies of written comments to
Docket Clerk, U.S. Department of Agriculture, Food Safety and
Inspection Service, Room 4352-S, Washington, DC 20250-3700. Please
refer to docket number 95-033P in your comments. Any person desiring an
opportunity for oral presentation of views as provided under the
Poultry Products Inspection Act should contact Dr. Paula M. Cohen at
(202) 720-7164 so that arrangements can be made. All comments submitted
in response to this proposal will be available for public inspection in
the Docket Clerk's Office between 8:30 a.m. and 1:00 p.m., and 2:00
p.m. and 4:30 p.m., Monday through Friday. To review the research and
other background information used by FSIS in developing this document,
persons may visit the Docket Clerk's office during the times listed
above.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Acting Deputy
Administrator, Science and Technology, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250-3700;
(202) 205-0699.
SUPPLEMENTARY INFORMATION:
Background
Under the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.)
and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.),
FSIS issues regulations governing the production of meat and poultry
products prepared for distribution in interstate and foreign commerce.
Many of these regulations employ the command-and-control approach,
prescribing a precise sequence of steps to be followed to produce food
that is safe and not adulterated.
Since 1972, FSIS has promulgated several regulations ensuring the
safety of various cooked and partially cooked meat and poultry
products. These regulations (9 CFR 318.17, 318.23, and 381.150)
prescribe specific steps establishments must follow to ensure harmful
bacteria are killed, growth of spore-forming bacteria is controlled,
and recontamination of the product is prevented. By describing detailed
safety procedures, this approach to rulemaking has provided clear
direction and ensured that all establishments are subject to the same
rules.
However, command-and-control regulations often do not account for
the uniqueness of individual processing procedures and needs within
different establishments. FSIS command-and-control regulations require
all establishments to produce meat and poultry products in the same
manner. Such prescriptive regulations are burdensome in many settings.
Further, command-and-control regulations can have disparate
economic effects on establishments producing different volumes of the
same product. By mandating the use of specific processes or
technologies, FSIS often inadvertently imposes economic burdens on
small businesses. Small establishments producing meat and poultry
products at low volumes often must pay a high cost per product unit
when required to employ a specific process or technology, while large
establishments are able to spread the cost over their higher production
volumes.
FSIS is now proposing to convert these regulations to performance
standards. Performance standards spell out the objective level of
performance establishments must meet during their operations in order
to produce safe and nonadulterated products, but allow the use of
plant-specific processing procedures, other than those prescribed in
the current regulations. Accordingly, establishments could employ
innovative or unique processing procedures customized to the nature and
volume of their production.
[[Page 19565]]
The conversion of command-and-control regulations to performance
standards is also an important element of the Agency's HACCP (Hazard
Analysis and Critical Control Points) initiative.
Performance Standards and HACCP
In the Federal Register of February 3, 1995 (60 FR 6774), FSIS
described a new food safety strategy based on clearly defining the
responsibility of meat and poultry establishments to produce products
that meet FSIS-established food safety performance standards. As a
central element of this new food safety strategy, FSIS has proposed
that all establishments adopt the science-based system of preventive
controls to ensure food safety, known as HACCP. Under HACCP,
establishments will be responsible for developing and implementing
HACCP plans incorporating the controls determined by the establishment
to be necessary and appropriate to produce safe products. HACCP is a
flexible system that enables establishments to tailor their control
systems to the needs of particular plants and processes.
Clearly defined food safety performance standards and HACCP are
both powerful tools for improving food safety. Under FSIS proposals to
implement performance standards and HACCP, establishments would have
the incentive and flexibility to adopt innovative, science-based food
safety processing procedures and controls. Furthermore, by focusing on
inspectional oversight of the manner in which establishments are
implementing HACCP plans and achieving performance standards, FSIS will
have a more effective means of ensuring that establishments are meeting
their food safety responsibilities.
Moreover, for HACCP to be successful, FSIS must reconsider its
current reliance on command-and-control regulations. As a general
matter, such regulations are incompatible with HACCP and the new food
safety strategy because they deprive plants of the flexibility to
innovate, one of the advantages of HACCP, and undercut the clear
delineation of responsibility for food safety on which the FSIS
strategy is based. Therefore, to prepare for the implementation of
HACCP, FSIS is conducting a thorough review of its current regulations
and, to the maximum extent possible, converting its command-and-control
regulations to performance standards. This proposal to convert the
current regulations governing the production of certain cooked beef
products, uncured meat patties, and certain poultry products into
performance standards is an important part of this effort.
The Integration of Performance Standards Into Establishment HACCP Plans
Establishments would have the option of developing customized
processing procedures designed to meet performance standards prior to
their implementation of the HACCP requirements. These establishments
would incorporate elements of their customized processing procedures
into their HACCP plans and, in fact, probably would develop these
processing procedures with HACCP in mind. Specifically, establishments
would incorporate the means they use to meet the performance standards
into their HACCP plans as critical limits.
When developing a HACCP plan, an establishment must first carry out
a hazard analysis to identify and list the physical, biological, or
chemical food safety hazards reasonably likely to occur in the
production process for a particular product and the preventive measures
necessary to control the hazards. The establishment then must identify
the critical control points (CCPs) in each of its processes. A CCP is
a point, step, or procedure at which control can be applied and a food
safety hazard can be prevented, eliminated, or reduced to an acceptable
level.
Next, the critical limits for preventive measures associated with
each identified CCP must be established. A critical limit is the
maximum or minimum value to which a process control measure must be
controlled at a CCP to prevent, eliminate, or reduce to an acceptable
level the identified food safety hazard. Critical limits are most often
based on process parameters such as temperature, time, water activity,
or humidity. Critical limits must be designed to satisfy relevant FSIS
regulations (including performance standards), FDA tolerances, and
action levels where appropriate.
The proposed performance standards set out quantifiable
microbiological pathogen reduction requirements for cooked beef
products, uncured meat patties, and certain fully and partially cooked
poultry products. Therefore, establishments would develop critical
limits based upon these performance standards. Of course, during hazard
analysis, establishments probably would identify other hazards not
addressed by these performance standards and would be required to
develop CCP's and critical limits accordingly. An example of how an
establishment might use performance standards to develop critical
limits follows.
Establishment X produces ready-to-eat poultry products and, as a
result of this proposal, would be required to meet three performance
standards: lethality, stabilization, and handling. To meet the
lethality standard, the establishment must achieve a 7-D reduction in
the microbiological pathogen Salmonella (explained below) in their
poultry products. As would most, if not all establishments,
Establishment X achieves this reduction in Salmonella through cooking.
Establishment X cooks its poultry at 155 deg.F for 16 seconds to
achieve a 7-D lethality.
As part of its HACCP plan, Establishment X must develop critical
limits for the preventive measures addressing the hazards associated
with producing ready-to-eat poultry products. Salmonella is identified
as one of those hazards by the lethality performance standard.
Therefore, Establishment X would incorporate the time/temperature
combination used to meet the lethality performance standard into its
HACCP plan as critical limits.
To meet the second performance standard, stabilization,
Establishment X must prevent the germination and multiplication of
toxigenic microorganisms such as C. botulinum and allow no more than a
1-decimal log multiplication of C. perfringens within its ready-to-eat
poultry products (further explained below). To meet this performance
standard, Establishment X decides to chill its poultry products
following cooking, to 80 deg.F within 1.5 hours and to 40 deg.F
within 5 hours. C. botulinum and C. perfringens are identified by the
stabilization performance standard as hazards that must be addressed
during the production of ready-to-eat poultry products. Therefore,
Establishment X would incorporate the time/temperature combination used
to meet the stabilization performance standard into its HACCP plan as
critical limits.
To meet the third performance standard for ready-to-eat poultry,
handling, Establishment X must ensure that no infectious pathogens are
introduced into the product following processes ensuring lethality and
stabilization and after final packaging. To meet the handling standard,
Establishment X cooks the packaged, raw poultry product in a room
physically separated from other rooms in which raw poultry and
ingredients are handled and packaged. Further, Establishment X assures
that raw materials entering the room for processing are stored
separately from the finished, ready-to-eat product. Finally,
Establishment X monitors the integrity of the packaged, ready-to-eat
[[Page 19566]]
product to ensure that there are no punctures or incomplete seals that
may cause contamination.
The Proposed Performance Standards and Commercial Sterility
As stated above, the performance standards proposed set out
quantifiable pathogen reduction requirements for cooked beef products,
uncured meat patties, and certain fully and partially cooked poultry
products. In the interest of further simplifying the food safety
regulations governing these products, FSIS might have proposed a single
performance standard: commercial sterility, or the elimination of all
microorganisms from these products.
However, achieving commercial sterility within cooked beef
products, uncured meat patties, and certain fully and partially cooked
poultry products would not be feasible. It would be technically
impossible for establishments to produce versions of these products
that are both commercially sterile and marketable. For example, using
current technology, it would be impossible to produce a ready-to-eat,
rare roast beef product that is commercially sterile.
The quantifiable pathogen reduction performance standards proposed
for these products would both ensure the production of safe food, with
an ample margin of safety, and be readily achievable by industry.
Further, as explained in the following section, these proposed
performance standards are intrinsic to the current regulations.
Safe Harbors
Products produced in accordance with the command-and-control
provisions in the current regulations governing cooked beef products,
uncured meat patties, and certain fully and partially cooked poultry
products would meet the proposed performance standards. Establishments
producing these products therefore would not be required to change any
current practices in response to this proposed rule. By proposing
performance standards that may be met through adherence to the current
regulations, FSIS creates a regulatory ``safe harbor'' for
establishments that wish to continue operating as is currently
required.
FSIS proposes to retain these regulatory safe harbors in the Code
of Federal Regulations (CFR), as examples of how establishments can
produce cooked beef products, uncured meat patties, and certain fully
and partially cooked poultry products that meet the performance
standards. Such examples would assist small or new establishments that
do not have the resources to develop customized process schedules for
these products. Though these regulatory safe harbors contain many
prescriptive and possibly obsolete requirements, the Agency wants to
provide options that allow establishments to continue operating as they
do under the current regulations. Therefore, in this proposal, the
regulatory safe harbors are presented with few changes from the current
regulations.
FSIS has announced a comprehensive review of regulatory procedures
and requirements to determine which are still needed and which ought to
be reconsidered, streamlined, or eliminated. As well as identifying
regulatory candidates for reform and repeal in general, this review
will establish priorities for revising regulations for compatibility
with HACCP and the new FSIS food safety strategy. As explained above,
under the new food safety strategy and HACCP, establishments will be
responsible for developing and implementing HACCP plans incorporating
the controls determined by the establishment to be necessary and
appropriate to produce safe products.
Many of the command-and-control provisions, inherent in the current
regulations and thus in the proposed safe harbors, must therefore be
eliminated, revised, or converted to performance standards. Command-
and-control regulations are generally incompatible with HACCP and the
new food safety strategy because they deprive establishments of the
flexibility to innovate and undercut the clear delineation of
responsibility for food safety on which the FSIS strategy is based.
FSIS will focus its review of the proposed regulatory safe harbors on
the most prescriptive provisions, especially those concerning prior
approval of customized processes or product disposition by FSIS program
officials. These prior approval requirements would be incompatible with
FSIS inspection under HACCP and would need to be eliminated before
HACCP implementation. Further, FSIS proposes to retain the safe harbors
only as examples of processes establishments can use to produce product
meeting the performance standard.
The safe harbors included in this proposal still contain provisions
requiring prior approval by FSIS program officials of customized
processes or product disposition. As stated above, FSIS must remove
these provisions prior to the implementation of HACCP. FSIS invites
comment on precisely how safe harbors should be revised in light of
HACCP and the new FSIS food safety strategy. FSIS also invites comment
on whether the Agency should provide regulatory safe harbors at all,
and if so, whether their retention in the Code of Federal Regulations
is necessary.
Process Schedule Approval and Validation
Prior to its development and implementation of a HACCP plan, an
establishment choosing to develop and use processing procedures
different from those provided in the safe-harbor examples would be
required to have on file, available to FSIS, a written process schedule
describing the specific operations employed by the establishment to
accomplish the objectives of the performance standards (FSIS would
amend the relevant information requirements in 9 CFR part 320). This
process schedule also would be required to contain the related control,
monitoring, validation, and corrective action activities associated
with the establishment's procedures. These activities are the good
sanitation and basic good manufacturing practices generally regarded as
essential prerequisites for the production of safe food. Further, these
activities would be similar, if not identical, to the control,
monitoring, validation, and corrective action activities developed by
the establishment as part of its HACCP plan. Accordingly, so not to
place duplicative requirements on establishments, FSIS would sunset
these process schedule requirements as HACCP is implemented.
The process schedule would have to be evaluated and approved for
safety and efficacy by a process authority. FSIS does not propose to
preapprove the procedures deemed acceptable by the establishment's
process authority. The proposed regulations define a process authority
as a person or organization with expert knowledge in meat and poultry
process control and relevant regulations.
The process authority would evaluate the establishment's
prospective processing procedures and, after using such devices as
laboratory challenge studies or comparison to peer-reviewed and -
accepted procedures, approve, in writing, the safety and efficacy of
the establishment's prospective procedures. The process authority must
have access to the establishment in order to evaluate the safety of
that establishment's planned production processes.
As stated above, FSIS proposes to sunset these proposed process
schedule requirements as establishments develop and implement HACCP
plans. These requirements would be duplicative of
[[Page 19567]]
what is required by HACCP, that is, an establishment would not need
both an approved process schedule and a validated HACCP plan for the
same process. FSIS anticipates that if an establishment developed a
process schedule for producing one of the aforementioned meat or
poultry products prior to implementing HACCP, it would incorporate
elements of that process schedule into its HACCP plan.
Also, FSIS proposes to require that prior to the implementation of
HACCP, establishments validate the process schedule by testing product
to determine that it meets the applicable performance standards.
Testing would have to be conducted in accordance with a sampling
program designed by the process authority to assure, with at least 95
percent statistical confidence, that an establishment's process
schedule will produce product that meets applicable performance
standards. Establishments could not release product for commercial use
until testing confirmed that the process schedule was producing product
meeting applicable performance standards. FSIS would require that
results of the product testing, as well as the sampling regimen, be
made available as the validation activities contained in the process
schedule.
It is an industry convention to confirm that new production
processes are safe and effective by holding and testing product prior
to its commercial release. Therefore, FSIS believes that this proposed
testing requirement for customized and essentially new process
schedules would not be burdensome for meat and poultry establishments.
Validation of process schedules through sampling prior to the
implementation of HACCP is a necessary step establishments must take to
ensure that their processes are producing safe food for commercial
distribution. FSIS realizes, however, that this particular form of
validation may not be appropriate in every circumstance. Therefore,
FSIS invites comment on the validation requirement proposed in this
document, specifically as to whether FSIS should prescribe this
specific method of validation for these process schedules, and, whether
the proposed testing requirement is in fact appropriate for ensuring
that an establishment's products meet food safety performance
standards.
Like the proposed requirements concerning the development,
approval, and maintenance of the process schedule, the process schedule
validation requirement would be sunsetted as HACCP is implemented. FSIS
would not require an establishment with a validated HACCP plan
producing meat and poultry products that meet performance standards
also to have on file a validated process schedule.
FSIS Inspection
After a process authority has approved an establishment's planned
procedures and before the production of lots to be held and tested, an
establishment would be required to notify FSIS that it is implementing
procedures different than those contained in the safe harbor provisions
of the regulations. This notification would facilitate FSIS inspection
in regard to these procedures. FSIS personnel would continue to perform
inspection tasks as scheduled by the Performance Based Inspection
System, as they do under the current regulations, in order to verify
that the product is processed according to the procedures on file and
meets the performance standards. FSIS in-plant inspection personnel
would not be evaluating the process authority-approved procedures for
efficacy, except through these in-plant verification tasks. FSIS
inspection of an establishment employing process authority-approved
procedures would be as rigorous as inspection of an establishment
employing safe-harbor procedures.
At all establishments, FSIS personnel would retain the authority to
sample product for verification or to take action on the process in
cases where noncompliance with Agency regulations is suspected or when
the process is not properly controlled. FSIS personnel would sample
products made with process authority-approved procedures at the same
frequency they sample products made with safe-harbor procedures.
Should an establishment wish to alter its approved procedures, the
process authority must evaluate and approve, in writing, the proposed
alterations prior to their implementation. The process authority would
approve only alterations that result in the continued production of
product meeting performance standards. Prior to the commercial release
of any product produced by process authority-approved, altered
procedures, testing requirements would again apply.
It is possible that the same process authority may service several
establishments owned by a single company. The process authority could
approve the same procedures for use at all of the establishments. FSIS
would allow such an arrangement, as long as the process authority-
approved procedure is on file at each establishment and each
establishment complies with the applicable testing provisions for the
product in question.
Any establishment operating under a Total Quality Control (TQC)
system (Sec. 318.4) and desiring to employ a processing procedure
approved by a process authority would be required to submit the
approved procedure through normal channels for incorporation into its
TQC system. FSIS would evaluate only the format of the approved
procedure, to allow its incorporation into the official FSIS-held
copies of the TQC system procedures.
Performance Standards for Cooked/Roast Beef Products, Cooked Uncured
Meat Patties, and Certain Cooked Poultry Products
To meet the proposed performance standards for cooked/roast beef
products, fully cooked, uncured meat patties, and certain fully cooked
poultry products, establishments would need to continue to eliminate
pathogenic microorganisms from these products. FSIS is proposing three
performance standards reflecting this goal: lethality, stabilization,
and handling. An establishment meeting these three standards would
produce ready-to-eat, cooked products containing no viable pathogenic
microorganisms.
Lethality
To meet the first standard, lethality, establishments must treat
ready-to-eat product so as to ensure a specific, significant reduction
in the number of pathogenic microorganisms in the product, effectively
eliminating the pathogenic microorganisms from the product. FSIS is not
proposing to require that any particular means be used to meet the
lethality standard. For these cooked products, FSIS would continue to
require a heat treatment. However, FSIS is not proposing to require
that cooking be the sole means by which lethality is to be achieved.
Other applicable treatments, such as curing, might be used in
combination with cooking to achieve the required lethality.
For the purpose of the lethality standard, reduction of pathogenic
microorganisms would be measured in D-values. A D-value indicates the
time required to reduce the viable microbial population by one
log10 unit at a given temperature:
D=t/log a-log b
where ``t'' is the time of heating, ``a'' the number of viable
organisms at ``t''=0 minutes, and ``b'' the number of surviving
organisms. A ``7-D'' process for Salmonella, for example, would
[[Page 19568]]
reduce Salmonella contamination by a factor of 10 million and would
ensure the effective elimination of Salmonella in a product
contaminated with as many as 10 million (107) organisms per gram.
For cooked beef, roast beef, and cooked corned beef products, FSIS
is proposing that the lethality performance standard be a 7-D reduction
in Salmonella. Traditionally, the pathogenic microorganism of concern
in cooked beef products has been Salmonella. Although E. coli 0157:H7
has emerged as a significant pathogen of concern in meat products,
Salmonella is generally slightly more resistant to heat than E. coli
0157:H7. Furthermore, while Salmonella is not as heat resistant as
Listeria monocytogenes, the presence of L. monocytogenes in finished
product is primarily a result of recontamination and the expected
levels of L. monocytogenes are much lower than those expected of
Salmonella. Therefore, the thermal destruction of Salmonella in cooked
beef products would indicate the destruction of the other two
pathogens. (To review the research and other background information
used by FSIS in developing this document, see ADDRESSES above.)
When the current regulations for cooked beef products were
promulgated, available research indicated that due to the
microbiological profile of beef and other factors, a 7-D reduction in
Salmonella was necessary to produce a safe cooked beef product, free of
pathogens. A 7-D reduction in Salmonella does effectively eliminate all
pathogenic microorganisms from cooked beef products and provides a
significant margin of safety. However, the Agency recognizes that the
required 7-D reduction in Salmonella may be overly conservative in
certain processing environments. For example, if an establishment with
an effective system of process controls were processing high quality
raw product into roast beef, it might not need to achieve a 7-D
reduction in Salmonella in order to produce safe product. Given the
variety of establishments producing cooked beef products, however,
requiring a 7-D reduction of Salmonella in these products provides for
a significant margin of safety throughout the industry.
FSIS also recognizes that developments in processing technology now
may indicate that a safe, ready-to-eat cooked beef product could be
produced with a different level of lethality. Raw beef is rarely
contaminated with Salmonella at levels in excess of three or four logs
(1,000-10,000 organisms) per gram of product. It is thus probable that
a 3-D or 4-D reduction in Salmonella would effectively eliminate all
pathogens from a cooked beef product.
The Agency invites submissions on this lethality standard. FSIS
would consider revising the lethality performance standard and safe
harbor example for cooked beef products in general if presented with
compelling data. FSIS also might consider revising the lethality
performance standard for cooked beef products produced under certain
combinations of conditions, such as those presented in the example
above. Such revisions would grant further flexibility to cooked beef
processors and encourage innovation, while ensuring the safety of the
food produced.
The current regulations in Sec. 318.17, governing the production of
cooked beef, roast beef, and cooked corned beef products, require,
among other things, that these products be cooked at certain
temperatures for certain periods of time (the table in paragraph (a) of
Sec. 318.17 lists the approved time/temperature combinations). When
applied, all of these time/temperature combinations produce a 7-D
lethality. Therefore, as a result of this proposal, establishments
continuing to follow the current regulations (the proposed safe
harbors) would produce cooked beef products that meet the 7-D lethality
standard presented in this document. And, notably, establishments that
choose to produce cooked beef products using procedures other than
those retained in the safe harbor regulations would be required to meet
the same rigorous measure of lethality.
For fully cooked, uncured meat patties, FSIS is proposing that the
lethality performance standard be a 5-D reduction in Salmonella. FSIS
has identified Salmonella as the target pathogenic microorganism in
fully cooked uncured meat patties, as in fully cooked beef products,
because its elimination indicates the elimination of other pathogenic
microorganisms. A 5-D reduction in Salmonella in cooked, uncured meat
patties effectively eliminates all pathogenic microorganisms, provides
a significant margin of safety, and allows for the production of a
marketable product (achieving a 7-D reduction of Salmonella in fully
cooked meat patties, as is mandated for cooked beef or poultry
products, would require a degree of processing that would render the
patties burnt, dry, and unacceptable to consumers).
As in the cooked beef product regulations, the regulations in
Sec. 318.23 governing the production of cooked, uncured meat patties
require that these products be cooked at certain temperatures for
certain periods of time (Table A, in paragraph (b)(1)(i) of Sec. 318.23
lists the approved time/temperature combinations). When applied, all of
these time/temperature combinations produce a 5-D lethality. Therefore,
as a result of this proposal, establishments continuing to follow the
current regulations (the proposed safe harbors) would produce cooked
meat patties that meet the 5-D lethality standard proposed in this
document. And, establishments that choose to produce cooked meat
patties using procedures other than those retained in the safe harbor
regulations would be required to meet the same rigorous measure of
lethality.
For the cooked poultry products described in Sec. 381.150, FSIS is
proposing that the lethality performance standard be a 7-D reduction in
Salmonella. FSIS has identified Salmonella as the target pathogenic
microorganism in cooked poultry products, as in fully cooked beef and
uncured meat patties, because its elimination indicates the elimination
of other pathogenic microorganisms. When the current regulations for
cooked poultry products were promulgated, available research indicated
that due to the microbiological profile of poultry and other factors, a
7-D reduction in Salmonella was necessary to produce a safe cooked
poultry product, free of pathogens. (To review the research and other
background information used by FSIS in developing this document, see
ADDRESSES above.) A 7-D reduction in Salmonella does effectively
eliminate all pathogenic microorganisms from cooked poultry products
and provides a significant margin of safety.
The Agency recognizes that the required 7-D reduction in Salmonella
may be overly conservative in certain processing environments. For
example, if an establishment with an effective system of process
controls were processing high quality raw product into ready-to-eat
cooked poultry, it might not need to achieve a 7-D reduction in
Salmonella in order to produce safe product. Given the variety of
establishments producing cooked poultry products, however, requiring a
70D reduction of Salmonella in these products provides for a
significant margin of safety throughout the industry.
Further, FSIS recognizes that developments in processing technology
now may indicate that in general, safe, ready-to-eat cooked poultry
products could be produced with a different level of lethality. It is
possible, for example, that a 3-D or 4-D reduction in
[[Page 19569]]
Salmonella would effectively eliminate all pathogens from cooked
poultry products.
The Agency invites submissions on the lethality standard for cooked
poultry products. FSIS would consider revising the lethality
performance standard and safe harbor example for cooked poultry
products in general if presented with compelling data. FSIS also might
consider revising the lethality performance standard for cooked poultry
products produced under certain combinations of conditions, such as
those presented in the example above.
The regulations in Sec. 381.150(b) governing the production of
cooked poultry products require that these products reach certain
internal temperatures prior to being removed from the cooking medium.
Meeting these internal temperature requirements ensures a 7-D reduction
of Salmonella. Therefore, as a result of this proposal, establishments
continuing to follow the current regulations (the proposed safe
harbors) would produce cooked poultry products that meet the 7-D
lethality standard proposed in this document. And, establishments that
choose to produce cooked poultry products using procedures other than
those retained in the safe harbor regulations would be required to meet
the same rigorous measure of lethality.
Stabilization
In order to meet the second performance standard, stabilization,
establishments must prevent vegetative spore-forming bacteria from
growing within product and producing toxin. If allowed to grow in
number, these bacteria can produce high concentrations of toxin, which
cause foodborne illness.
Means applied to products to bring about the lethality of certain
pathogenic microorganisms, such as Salmonella, can create a model
environment for the multiplication of spore-forming bacteria. For
example, cooking or heat processing is likely to be applied to a
product in order to eliminate Salmonella and other pathogenic
microorganisms. Clostridium botulinum spores, Clostridium perfringens
spores, and spores from other vegetative and spore-forming bacteria can
survive cooking and, in fact, thrive in the warm product following
cooking when competitive microorganisms, such as Salmonella, have been
eliminated.
Therefore, it is important that the stabilization conditions are
implemented so that vegetative, spore-forming bacteria do not have an
opportunity to grow within the product. Accordingly, FSIS is proposing
that stabilization, likely to be rapid cooling following cooking, must
prevent the germination and multiplication of toxigenic microorganisms
such as C. botulinum, and allow no more than a 1-decimal log
multiplication of C. perfringens. Limiting the allowable growth of C.
perfringens to a 1-decimal log multiplication would effectively limit
the multiplication of other, slower growing spore-forming bacteria,
such as Bacillus cereus and Staphylococcus aureus.
The current regulations for cooked beef products and cooked meat
patties require, among other things, that these cooked products be
quickly cooled following cooking, in order to inhibit the growth of
vegetative, spore-forming bacteria. Section 318.17(h)(10) requires that
establishments begin chilling cooked beef products within 90 minutes of
heat processing. The products must be chilled from 120 deg.F to 55
deg.F in no more than 6 hours, chilling must continue until shipment,
and the product cannot be packed for shipment until it has reached 40
deg.F. Section 318.23(b) requires that cooked meat patties be cooled to
an internal temperature of 40 deg.F or below within 2 hours of heat
processing. When applied, the chilling requirements for both cooked
beef products and cooked meat patties prevent the germination and
multiplication of toxigenic microorganisms such as C. botulinum and
allow no more than a 1-decimal log multiplication of C. perfringens,
that is, they produce cooked products that meet the stabilization
performance standard presented in this document.
The chilling requirements for the cooked poultry products concerned
in this proposal are not set out in the regulations for these products,
Sec. 381.150, but instead in FSIS Directive 7110.3, ``TIME/TEMPERATURE
GUIDELINES FOR COOLING HEATED PRODUCTS.'' This directive states that
following heat treatment, cooked poultry products should be chilled to
80 deg.F within 1.5 hours, and to 40 deg.F within 5 hours. When
applied, this chilling prevents the germination and multiplication of
toxigenic microorganisms such as C. botulinum and allows no more than a
1-decimal log multiplication of C. perfringens, that is, it produces
cooked poultry products that meet the stabilization performance
standard presented in this document.
Therefore, as a result of this proposal, establishments continuing
to follow the current regulations regarding the chilling of cooked beef
and meat patty products or the directive regarding the chilling of
cooked poultry products (the proposed safe harbors) would produce
cooked products that meet the stabilization standard for cooked
products presented in this document. And, establishments that choose to
produce cooked products using procedures other than those retained in
the proposed safe harbors would be required to meet the same rigorous
measure of stabilization.
FSIS is proposing to amend the current regulations in Sec. 381.150
(the proposed safe harbor for certain cooked poultry products) by
adding the chilling requirements for cooked poultry currently contained
in FSIS Directive 7110.3. This proposed amendment would help to clarify
and complete in a single section of the Poultry Products Inspection
Regulations the proposed safe harbor regulations for certain cooked
poultry products.
Handling
To meet the third performance standard for cooked products,
establishments would need to handle product to preclude its
recontamination by infectious pathogenic microorganisms. This standard
requires that no infectious pathogens are introduced into the product
following processes ensuring lethality, stabilization, or final
packaging.
The current regulations for cooked beef products and cooked meat
patties require, among other things, that these cooked products be
handled, throughout processing, in a manner precluding their
recontamination by infectious pathogenic microorganisms. Section
318.17, paragraphs (i), (j), and (k) require that establishments take
various measures to ensure that cooked beef products are not
recontaminated by contact with raw product, unsanitary work surfaces or
machines, employee gloves or garments, and other sources of
contamination. Section 318.23, paragraph (b)(4) requires establishments
to take similar measures to ensure that cooked meat patties are not
recontaminated.
Therefore, as a result of this proposal, establishments continuing
to follow the current regulations regarding handling of cooked beef and
meat patty products (the proposed safe harbors) would produce cooked
beef products and cooked meat patties that meet the handling standard
for cooked products proposed in this document. And, establishments that
choose to produce cooked beef products and cooked meat patties using
procedures other than those retained in the proposed safe harbors would
be required to meet the same rigorous measure of handling.
[[Page 19570]]
Section 381.150 of the regulations contains no specific handling
requirements for cooked poultry products. FSIS is proposing to amend
the regulations contained in Sec. 381.150 by adding specific handling
requirements for cooked poultry products. These proposed handling
requirements are modeled after those currently in place for cooked beef
products and cooked meat patties. Consequently, adherence to these
proposed handling requirements for cooked poultry products would assure
establishment compliance with the proposed handling performance
standard. The addition of these handling requirements to the proposed
regulatory safe harbor would clarify existing sanitation requirements
and assist establishments that do not have the resources to develop
customized process schedules for these products.
FSIS experience with establishments producing the cooked poultry
products defined under Sec. 381.150 indicates that the proposed
handling requirements represent current good manufacturing practices
(GMPs) accepted by industry. These handling GMPs, including the
separation of raw and cooked product, sanitation of work surfaces, and
appropriate packaging, are generally regarded as essential for
preventing the direct and indirect contamination of cooked product.
Poultry establishments already following the proposed handling safe
harbor requirements would not have to change their handling procedures
in order to meet the proposed handling performance standards. These
establishments may wish to take advantage of the flexibility afforded
by the proposed performance standards, however, and develop handling
procedures that more closely match their unique production practices.
Establishments that do not have handling procedures in place that meet
the proposed safe harbor requirements, would be required to either
adhere to the proposed safe harbor handling requirements or develop
procedures that meet the proposed handling performance standard. FSIS
is requesting comment on the possible economic impact of these proposed
handling requirements (see ``Executive Order 12866 and Regulatory
Flexibility Act,'' below).
Performance Standards for Partially Cooked and Char-Marked Meat Patties
and Partially Cooked Poultry Breakfast Strips
Unlike the fully cooked, ready-to-eat products described above,
partially cooked and char-marked uncured meat patties and partially
cooked poultry breakfast strips are essentially raw, and require
adequate cooking prior to consumption. A lethality performance standard
therefore would not apply to partially cooked and char-marked products,
since FSIS does not require that these products be ready-to-eat.
Neither would a handling performance standard apply, since these raw
products may contain infectious pathogenic microorganisms after
processing and prior to cooking. FSIS is proposing, however, that
establishments producing these products meet a stabilization
performance standard identical to the stabilization standard proposed
above for fully cooked products.
During processing, these products are partially cooked and then
cooled, which creates a model environment for the growth of C.
perfringens, C. botulinum, and other spore-forming, toxigenic bacteria.
Cooking by the consumer, retailer, or other end-user may not eliminate
these bacteria from these products. Therefore, it is important that
bacterial growth be controlled in these products to the extent possible
while they remain at the producing establishment. Accordingly, FSIS is
proposing that in partially cooked and char-marked uncured meat patties
and partially cooked poultry breakfast strips, establishments prevent
the germination and multiplication of toxigenic microorganisms such as
C. botulinum, and allow no more than a 1-decimal log multiplication of
C. perfringens.
The current regulations for partially cooked and char-marked
uncured meat patties and partially cooked poultry breakfast strips
require, among other things, that these products be quickly chilled
following partial cooking or char-marking, in order to inhibit the
growth of vegetative, spore-forming bacteria. Section 318.23, paragraph
(b)(1)(ii) requires that partially cooked meat patties be cooled to a
maximum internal temperature of 40 deg.F within 2 hours following
partial cooking. Section 318.23, paragraph (b)(1)(iii) requires that
char-marked meat patties be char-marked and then cooled to a maximum
internal temperature of 40 deg.F within 2 hours. Section 381.150,
paragraph (a) requires that following partial cooking, partially cooked
poultry breakfast strips be cooled to 80 deg.F within 1.5 hours and to
40 deg.F within 5 hours. When applied, these chilling requirements
prevent the germination and multiplication of toxigenic microorganisms
such as C. botulinum and allow no more than a 1-decimal log
multiplication of C. perfringens, that is, they produce partially
cooked and char-marked products that meet the stabilization performance
standard presented in this document.
Therefore, as a result of this proposal, establishments continuing
to follow the current regulations regarding the chilling of partially
cooked and char-marked uncured meat patties and partially cooked
poultry breakfast strips (the proposed safe harbors) would produce
cooked products that meet the stabilization standard for partially
cooked products proposed in this document. And, establishments that
choose to produce these products using procedures other than those
retained in the proposed safe harbors would be required to meet the
same rigorous measure of stabilization.
FSIS requires that partially cooked and char-marked meat patties,
as well as partially cooked poultry breakfast strips, be labeled with
cooking directions. It is imperative that consumers fully cook these
products, as they are essentially raw, and may contain viable
pathogenic microorganisms. Therefore, FSIS is proposing that these
labeling requirements remain in the regulations governing partially
cooked and char-marked meat patties and partially cooked poultry
breakfast strips.
Miscellaneous
Section 317.2, paragraph (l) and Sec. 381.125, paragraph (b) of the
regulations require that safe handling instructions be provided for
beef products, meat patties, and poultry products not heat processed in
a manner that conforms to the time and temperature combinations listed
in Secs. 318.17, 318.23, and 381.150, respectively. This proposal,
however, would allow ready-to-eat products to be processed by means
other than the time and temperature requirements currently prescribed
in these sections, as long as they met the performance standards
proposed. Therefore, as a result of this proposal, safe handling label
requirements would not be applicable to all ready-to-eat products
processed by means other than the currently prescribed time and
temperature combinations. FSIS proposes to amend 317.2, paragraph (l)
and Sec. 381.125, paragraph (b), to reflect this change.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.
[[Page 19571]]
In accordance with 5 U.S.C. 603, we have performed an Initial
Regulatory Flexibility Analysis, which is set out below, regarding the
impact of this rule on small entities. However, we do not currently
have all the data necessary for a comprehensive analysis of the effects
of this rule on small entities. Therefore, we are inviting comments
concerning potential effects. In particular, we are interested in
determining the number and kind of small entities that may incur
benefits or costs from implementation of this proposed rule.
This rule would allow individual establishments to employ
processing methods other than those currently mandated, as long as
those methods yield products that meet the performance standards set
out in this rule. Since the currently mandated methods meet the
performance standards and would be retained as ``safe harbors,''
establishments could choose to continue using their current methods and
probably incur no new expenses (or savings or income) as a result of
this rule. Therefore, we anticipate that the rule would have a
favorable economic impact on all establishments, regardless of size.
As stated above, FSIS is proposing to amend the current regulations
in Sec. 381.150 (the proposed safe harbor for certain cooked poultry
products) by adding the chilling requirements for cooked poultry
currently contained in FSIS Directive 7110.3. This proposed amendment
would help to clarify and complete in a single section of the Poultry
Products Inspection Regulations the proposed safe harbor regulations
for certain cooked poultry products. Because establishments producing
cooked poultry products already must meet the chilling requirements set
forth in FSIS Directive 7110.3, FSIS anticipates that codifying these
requirements in the regulations would have no economic impact.
Also, because currently there are no explicit handling regulations
for cooked poultry products, some establishments may be required to
develop new procedures in order to meet the proposed handling
performance standard for cooked products. Establishments already
following the proposed handling safe harbor requirements would not have
to change their handling procedures in order to meet the proposed
handling performance standards. These establishments may wish to take
advantage of the flexibility afforded by the proposed performance
standards, however, and develop handling procedures that more closely
match their unique production practices. Establishments that do not
have handling procedures in place that meet the proposed safe harbor
requirements, would be required to either adhere to the proposed safe
harbor handling requirements or develop procedures that meet the
proposed handling performance standard.
FSIS anticipates that any impact on these firms would be minimal,
because the proposed handling requirements for cooked poultry products
represent current GMPs accepted and in general use by industry. Data
necessary for a comprehensive analysis of the effects of these proposed
handling safe harbors on poultry establishments is not currently
available to FSIS. Therefore, FSIS invites public comment concerning
potential economic effects of these proposed requirements.
When an establishment wants to use a processing method other than
those contained in the safe harbors, either because it will be more
efficient or improve its product, we can assume by its decision to
incur the expense of using that method (only a small part of which
would be to meet the requirements of the proposed rule) that it expects
to receive increased revenues in the future from the investment in the
method. In that sense, the rule could have favorable economic
consequences for firms that choose to innovate. Also, the increased
flexibility to innovate allowed by the rule could encourage competition
and benefit consumers with lower prices or higher quality products.
It is difficult to quantify the potential benefits of this proposal
since it is not possible to predict exactly how many establishments
would develop innovative processes and how these innovations would
generate revenues or benefits to consumers. There are approximately
1,000 establishments currently producing the cooked beef products,
uncured meat patties, and poultry products addressed by this proposal.
FSIS expects that only about five to ten percent of these
establishments would choose to develop customized process schedules
prior to the implementation of HACCP. FSIS anticipates that most, if
not all, of these establishments would develop alternative process
schedules for the production of ready-to-eat poultry products.
Under the current regulations, FSIS requires that ready-to-eat
poultry products reach specific, minimum internal temperatures before
being removed from a cooking medium. The products lose water during
cooking at these temperatures and consequently, establishments must add
water and other ingredients both to make the products palatable and to
restore lost yield.
Therefore, FSIS anticipates that most establishments initially
taking advantage of the proposed performance standards would develop
customized process schedules for ready-to-eat poultry products and
would benefit from some cost savings. FSIS expects that most
establishments producing roast beef and meat patty products would not
develop customized process schedules prior to implementing HACCP, as it
would be less duplicative and more cost-effective to use the proposed
performance standards to develop critical limits within HACCP plans.
Finally, there is the potential for an increase in the efficiency
of the nation's economy in general because the proposed rule encourages
businesses to consider a more efficient use of resources. Also, the
possibility of reduced prices of meat or poultry products are economic
factors that could produce a more efficient use of resources in the
economy as a whole. These effects would be small for individual firms
and consumers, but could be substantial in the aggregate.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act and the Poultry Products Inspection Act
(PPIA) from imposing any marking or packaging requirements on federally
inspected meat and poultry products that are in addition to, or
different than, those imposed under the FMIA or the PPIA. States and
local jurisdictions may, however, exercise concurrent jurisdiction over
meat and poultry products that are outside official establishments for
the purpose of preventing the distribution of meat and poultry products
that are misbranded or adulterated under the FMIA or PPIA, or, in the
case of imported articles, which are not at such an establishment,
after their entry into the United States.
This proposed rule is not intended to have retroactive effect.
There are no applicable administrative procedures that must be
exhausted prior to any judicial challenge to the provisions of this
proposed rule. However, the administrative procedures specified in 9
CFR Secs. 306.5 and 381.35 must be exhausted prior to any judicial
challenge of the application of the provisions of this proposed rule,
if the challenge involves any decision of an FSIS employee relating to
inspection
[[Page 19572]]
services provided under the FMIA or the PPIA.
Paperwork Requirements
Title: Performance Standards for Certain Meat and Poultry Products.
Type of Collection: New.
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act. Under this proposed rule, establishments choosing to
meet performance standards for certain cooked beef products, uncured
meat patties, and certain fully and partially cooked poultry products
either by means other than those described in the current regulations
or under the HACCP requirements, would be required to develop a written
process schedule and maintain a copy of the process schedule on file.
The process schedule would detail all the specific, sequential
operations that compose the process used by each establishment to
produce its specific products. The process schedule would also contain
the related control, monitoring, validation, and corrective action
activities associated with the procedure. Further, this process
schedule must have been evaluated and approved for safety, efficacy,
and equivalency by a process authority.
FSIS inspectors would initially, and periodically as required,
review the process schedule and any other relevant records to ensure
that the product is processed according to the procedures on file. FSIS
personnel would not evaluate the process authority-approved procedures
for efficacy.
Again, developing and implementing processing procedures different
from those in the current regulations would be optional. FSIS assumes
that an establishment would develop and implement such processing
procedures only if the resulting economic advantages outweighed the
accompanying costs, including the paperwork burden.
FSIS is proposing to amend the current regulations in Sec. 381.150
(the proposed safe harbor for certain cooked poultry products) by
adding the chilling requirements for cooked poultry currently contained
in FSIS Directive 7110.3. The paperwork burden hours for FSIS Directive
7110.3 are approved under OMB control number 0583-0089.
Finally, because currently there are no explicit handling
regulations for cooked poultry products, some establishments may be
required to develop new procedures in order to meet the proposed
handling performance standard for cooked products. FSIS has accounted
for the paperwork and recordkeeping burden hours resulting from the
proposed handling requirements in the estimate of burden for process
schedules below.
Estimate of Burden: FSIS estimates that the process schedule would
take an average of 2 days (16 hours) to develop and 5 minutes to file.
The written description of the establishment validation procedures,
whether conducted for new or altered process schedules, would take no
more than 1 day (8 hours) to complete and 5 minutes to file.
Respondents: Meat and poultry product establishments.
Estimated Number of Respondents: 1,000 (this number represents the
total number of establishments that could change their operations).
Estimated Number of Responses per Respondent: 1.
Estimated Total Annual Burden on Respondents: 24,166 hours.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, South Agriculture Building, Room 3812, Washington, DC
20250.
Comments are invited on: (a) whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology. Comments may be sent to Lee
Puricelli, Paperwork Specialist, see address above, and Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253.
Comments are requested by July 1, 1996. To be most effective,
comments should be sent to OMB within 30 days of the publication date
of this proposed rule.
List of Subjects
9 CFR Part 301
Meat inspection.
9 CFR Part 317
Food labeling.
9 CFR Part 318
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 381
Poultry and poultry products inspection, Reporting and
recordkeeping requirements.
Accordingly, title 9, chapter III, of the Code of Federal
Regulations would be amended as follows:
PART 301--DEFINITIONS
1. The authority citation for part 301 would be revised to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
2. Section 301.2 would be amended by removing the paragraph
designations (a) through (yyy) and adding, in alphabetical order, new
definitions for ``Process Schedule'' and ``Process authority'' to read
as follows:
Sec. 301.2 Definitions.
* * * * *
Process authority. A person or organization with expert knowledge
in meat production process control and relevant regulations. This
definition does not apply to subpart G of this part.
Process schedule. A process schedule is a written description of
processing procedures, consisting of any number of specific, sequential
operations directly under control of the establishment employed in the
manufacture of a specific product, including the control, monitoring,
validation, and corrective action activities associated with
production. This definition does not apply to subpart G of this part.
* * * * *
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
3. The authority citation for part 317 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
4. In Sec. 317.2, paragraph (l) would be revised to read as
follows:
Sec. 317.2 Labels: definition; required features.
* * * * *
(l) Safe handling instructions shall be provided for: All meat and
meat products of cattle, swine, sheep, goat, horse, or other equine not
heat processed in a manner that conforms to the time and temperature
combinations in the Table for Time/Temperature
[[Page 19573]]
Combination For Cooked Beef, Roast Beef, and Cooked Corned Beef in
Sec. 318.17 of this chapter, or that have not undergone other
processing that would render them ready-to-eat; and all comminuted meat
patties not processed in accordance with the standard for fully cooked
patties in Sec. 318.23 of this chapter; except as exempted under
paragraph (l)(4) of this section.
* * * * *
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
5. The authority citation for part 318 would be revised to read as
follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
6. Section 318.17 would be revised to read as follows:
Sec. 318.17 Requirements for the production of cooked beef, roast
beef, and cooked corned beef products.
(a) Cooked beef, roast beef, and cooked corned beef products must
be produced using processes ensuring that the products meet the
following performance standards:
(1) Lethality. A 7-decimal log reduction of Salmonella must be
achieved within the product. The lethality process must include a
cooking step.
(2) Stabilization. There can be no germination and multiplication
of toxigenic microorganisms such as Clostridium botulinum, and no more
than a 1-decimal log multiplication of Clostridium perfringens within
the product.
(3) Handling. There can be no recontamination of product by
infectious pathogens at any time from processing through the final
packaging.
(b) For each product produced using a process other than the
process provided as an example in paragraph (e) of this section or a
process conducted in accordance with the Hazard Analysis and Critical
Control Point (HACCP) system requirements set, an establishment must
develop and have on file, available to FSIS, a process schedule, as
defined in Sec. 301.2 of this chapter. Each process schedule must be
approved, in writing, by a process authority for safety and efficacy in
meeting the performance standards established for the product in
question. A process authority must have access to an establishment in
order to evaluate and approve the safety and efficacy of each process
schedule.
(c) Establishments must validate the process schedule by producing
and testing product against applicable performance standards, in
accordance with a statistically valid sampling program designed by the
process authority. No product can released for commercial use until
samples are tested and found to meet the applicable performance
standards. After a process authority has approved an establishment's
process schedule and before the production of lots to be held and
tested, the establishment must notify FSIS that it is implementing a
process other than that described in paragraph (e) of this section.
(d) Should an establishment wish to alter any procedures contained
in an approved process schedule, a process authority must evaluate and
approve, in writing, the proposed alterations prior to their
implementation. The process authority can approve only alterations that
result in the continued production of product meeting applicable
performance standards. Prior to the commercial release of any product
produced by approved, altered procedures, the establishment must
validate the altered process schedule by sampling and testing product
in accordance with a statistically valid sampling program designed by
the process authority; the tested product must meet applicable
performance standards.
(e) Example. An establishment may produce cooked beef, roast beef,
and cooked corned beef products using the processes described in the
following example, which meets the performance standards listed in
paragraph (a) of this section:
(1) Cooked beef and roast beef, including sectioned and formed
roasts and chunked and formed roasts, and cooked corned beef shall be
prepared by one of the time and temperature combinations in the
following table. The stated temperature is the minimum which shall be
produced and maintained in all parts of each piece of meat for at least
the stated time:
Table for Time/Temperature Combination for Cooked Beef, Roast Beef, and
Cooked Corned Beef
------------------------------------------------------------------------
Minimum internal temperature Minimum
------------------------------------------------------------ processing
time in
minutes
Degrees after
Degrees Fahrenheit Centigrade minimum
temperature
is reached
------------------------------------------------------------------------
130............................................ 54.4 121
131............................................ 55.0 97
132............................................ 55.6 77
133............................................ 56.1 62
134............................................ 56.7 47
135............................................ 57.2 37
136............................................ 57.8 32
137............................................ 58.4 24
138............................................ 58.9 19
139............................................ 59.5 15
140............................................ 60.0 12
141............................................ 60.6 10
142............................................ 61.1 8
143............................................ 61.7 6
144............................................ 62.2 5
145............................................ 62.8 (\1\)
------------------------------------------------------------------------
\1\ Instantly.
(2) Cooked beef, including sectioned and formed roasts and chunked
and formed roasts, and cooked corned beef shall be moist cooked
throughout the process or, in the case of roast beef or corned beef to
be roasted, cooked as provided in paragraph (e)(3) of this section. The
moist cooking may be accomplished by placing the meat in a sealed,
moisture impermeable bag, removing the excess air, and cooking,
completely immersing the meat, unbagged, in water throughout the entire
cooking process, or using a sealed oven or steam injection to raise the
relative humidity above 90 percent throughout the cooking process.
(3) Roast beef or corned beef to be roasted shall be cooked by one
of the following methods:
(i) Heating roasts of 10 pounds or more in an oven maintained at
250 degrees F. (121 degrees C.) or higher throughout the process;
(ii) Heating roasts of any size to a minimum internal temperature
of 145 degrees F. (62.8 degrees C.) in an oven maintained at any
temperature if the relative humidity of the oven is maintained either
by continuously introducing steam for 50 percent of the cooking time or
by use of a sealed oven for over 50 percent of the cooking time, or if
the relative humidity of the oven is maintained at 90 percent or above
for at least 25 percent of the total cooking time, but in no case less
than 1 hour; or
(iii) Heating roasts of any size in an oven maintained at any
temperature that will satisfy the internal temperature and time
requirements of paragraph (e)(1) of this section if the relative
humidity of
[[Page 19574]]
the oven is maintained at 90 percent or above for at least 25 percent
of the total cooking time, but in no case less than 1 hour.
(iv) The relative humidity may be achieved by use of steam
injection or by sealed ovens capable of producing and maintaining the
required relative humidity.
(4)(i) Except as provided in paragraph (e)(4)(ii) of this section,
establishments producing cooked beef, roast beef, or cooked corned beef
shall have sufficient monitoring equipment, including recording
devices, to assure that the time (within 1 minute), the temperature
(within 1 degree F.), and relative humidity (within 5 percent) limits
of these processes are being met. Data from the recording devices shall
be made available to a program employee upon request.
(ii) In lieu of recording devices, establishments may propose in
the written procedures prescribed in paragraph (e)(6) of this section,
an alternative means of providing inspection personnel with evidence
that finished product has been prepared in compliance with the humidity
requirements of paragraphs (e)(2) and (e)(3) of this section, and the
145 degrees F. (62.8 degrees C.) temperature requirements of paragraph
(e)(1) of this section.
(5) Each package of finished product shall be plainly and
permanently marked on the immediate container with the date of
production either in code or with the calendar date.
(6) In order to assure that cooked beef, roast beef, and cooked
corned beef are handled, processed, and stored under sanitary
conditions, the establishment shall submit a set of written procedures
through the inspector-in-charge for approval by the Regional Director.
The written procedures shall include the following information:
(i) The temperature to which raw frozen product is thawed and the
time required.
(ii) The lot identification procedure for lots of product during
processing.
(iii) The storage time and temperature combinations which the
establishment intends to use before cooking, the cooking time and
temperature the establishment intends to use, and the time, if any, the
establishment intends to wait after cooking and before cooling.
(iv) If a code, instead of the calendar date, is used on the
immediate container of the finished product, its meaning shall also be
included.
(v) Any other critical control points in the procedures which could
affect the safety of the product.
(vi) In lieu of recording devices, the alternate means permitted by
paragraph (e)(4)(ii) of this section for providing evidence to
inspection personnel that the finished product will be prepared in
compliance with temperature or humidity requirements.
(vii) Any other alternate procedure used that is permitted in this
section.
(7) The establishment shall maintain records and reports which
document the time, temperature, and humidity at which any cooked beef,
roast beef, or cooked corned beef is cooked and cooled at the
establishment. Such records shall be kept by the establishment for 6
months or for such further period as the Administrator may require for
purposes of any investigation or litigation under the Act, by written
notice to the person required to keep such records. Such records shall
be made available to the inspector or any duly authorized
representative of the Secretary upon request.
(8) The handling and processing of cooked beef, roast beef, and
cooked corned beef before, during, and after cooking shall be such as
to prevent the finished product from being adulterated. As a minimum,
they shall be controlled as follows:
(i) The establishment shall notify the inspector-in-charge which
processing procedure will be used on each lot, including time and
temperature.
(ii) In order to assure uniform heat penetration and consequent
adequate cooking of each piece of beef, individual pieces of raw
product in any one lot shall either not vary in weight by more than 2
pounds or not vary in thickness by more than 2 inches at the thickest
part. Alternate methods of assuring uniform heat penetration may be
submitted in writing for approval to the Regional Director.
(iii) A water-based solution that is used for injecting or
immersing the meat shall be refrigerated to 50 degrees F. (10 degrees
C.) or lower from the time it contacts the meat, and shall be filtered
each time it is recirculated or reused.
(iv) A nonmeat ingredient, including the water-based solution in
paragraph (e)(8)(iii) of this section, which has contacted meat shall
be discarded at the end of that day's production unless it is in
continuous contact with one batch of product.
(v) Product prepared for cooking shall be entered into the cooking
cycle within 2 hours of completion of precooking preparation, or be
placed immediately in a cooler at a temperature of 40 degrees F. (4.4
degrees C.) or lower.
(vi) The time and temperature requirements shall be met before any
product in the lot is removed from the cooking units. Unless otherwise
specified in the written procedures approved in accordance with
paragraph (e)(6) of this section, the heat source shall not be shut off
until these requirements are met.
(vii) Other than incidental contact caused by water currents during
immersion cooking or cooling, product shall be placed so that it does
not touch or overlap other products. This provision does not apply to
product that is stirred or agitated to assure uniform heat transfer.
(viii) Temperature sensing devices shall be so placed that they
monitor product in the coldest part of the cooking unit; and when an
oven temperature is required by paragraph (e)(3) of this section, the
oven temperature shall also be monitored in the coldest part of the
cooking unit.
(ix) If a humidity sensing device is required in an oven, it shall
be placed so that it measures humidity in either the oven chamber or at
the exit vent.
(x) Chilling shall begin within 90 minutes after the cooking cycle
is completed.
(A) All product shall be chilled from 120 degrees F. (48.8 degrees
C.) to 55 degrees F. (12.7 degrees C.) in no more than 6 hours.
(B) Chilling shall continue and the product shall not be packed for
shipment until it has reached 40 degrees F. (4.4 degrees C.).
(xi) Any establishment that has experienced a cooking process
deviation during preparation of product may either reprocess the
product completely, continue the heating to 145 degrees F. (62.8
degrees C.), or contact the Regional Director for a review of the
process schedule for adequacy and, if needed, for a cooking schedule to
finish that one batch of product.
(xii) An establishment that has experienced a cooling deviation
after the product has been cooked shall contact the Regional Director
to determine the disposition of that retained product.
(9) Cooked beef, roast beef, and cooked corned beef shall be so
handled as to assure that the product is not recontaminated by direct
contact with raw product. To prevent direct contamination of the cooked
product, establishments shall:
(i) Physically separate areas where raw product is handled from
areas where exposed cooked product is handled, using a solid impervious
floor to ceiling wall;
(ii) Handle raw and exposed cooked product at different times, with
a cleaning of the entire area after the raw material handling is
completed and
[[Page 19575]]
prior to the handling of cooked product in that area; or
(iii) Submit a written procedure for approval through the
inspector-in-charge to the Circuit Supervisor detailing the steps to be
taken which would avoid recontamination of cooked product by raw
product during processing.
(10) To prevent indirect contamination of cooked product:
(i) Any work surface, machine, or tool which contacts raw product
shall be thoroughly cleaned and sanitized with a solution germicidally
equivalent to 50 ppm chlorine before it contacts cooked product;
(ii) Employees shall wash their hands and sanitize them with a
solution germicidally equivalent to 50 ppm chlorine whenever they enter
the heat processed product area or before preparing to handle cooked
product, and as frequently as necessary during operations to avoid
product contamination; and
(iii) Outer garments, including aprons, smocks, and gloves, shall
be especially identified as restricted for use in cooked product areas
only, changed at least daily, and hung in a designated location when
the employee leaves the area.
(11) Cooked product shall not be stored in the same room as raw
product unless it is first packaged in a sealed, water-tight container
or is otherwise protected by a covering that has been approved, upon
written request, by the Circuit Supervisor.
7. Section 318.23 would be revised to read as follows:
Sec. 318.23 Requirements for the production of uncured meat patties.
(a) Fully cooked, uncured meat patties must be produced using
processes ensuring that the products meet the following performance
standards:
(1) Lethality. A 5-decimal log reduction of Salmonella must be
achieved within the product. The lethality process must include a
cooking step.
(2) Stabilization. There can be no germination and multiplication
of toxigenic microorganisms such as Clostridium botulinum, and no more
than a 1-decimal log multiplication of Clostridium perfringens within
the product.
(3) Handling. There can be no recontamination of product by
infectious pathogens at any time from processing through the final
packaging.
(b) Partially cooked and char-marked meat patties must be produced
using processes ensuring that the products meet the performance
standard listed in paragraph (a)(2) of this section.
(1) Partially cooked patties must bear the labeling statement
``Partially cooked: For Safety Cook Until Well Done (Internal Meat
Temperature 160 degrees F.)''. The labeling statement must be adjacent
to the product name, at least one-half the size of the largest letter
in the product name, and prominently placed with such conspicuousness
(as compared with other words, statements, designs or devices in the
labeling) as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
(2) Char-marked patties must bear the labeling statement
``Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal
Meat Temperature 160 degrees F.)''. The labeling statement shall be
adjacent to the product name, at least one-half the size of the largest
letter in the product name, and prominently placed with such
conspicuousness (as compared with other words, statements, designs or
devices in the labeling) as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(c) For each product produced using a process other than the
process described in paragraph (f) of this section or a process
conducted in accordance with the Hazard Analysis and Critical Control
Point (HACCP) system requirements, an establishment must develop and
have on file, available to FSIS, a process schedule, as defined in
Sec. 301.2 of this chapter. Each process schedule must be approved, in
writing, by a process authority for safety and efficacy in meeting the
performance standards established for the product in question. A
process authority must have access to an establishment in order to
evaluate and approve the safety and efficacy of each process schedule.
(d) Establishments must validate the process schedule by producing
and testing product against applicable performance standards, in
accordance with a statistically valid sampling program designed by the
process authority. No product can released for commercial use until
samples are tested and found to meet the applicable performance
standards. After a process authority has approved an establishment's
process schedule and before the production of lots to be held and
tested, the establishment must notify FSIS that it is implementing a
process other than that described in paragraph (f) of this section.
(e) Should an establishment wish to alter any procedures contained
in an approved process schedule, a process authority must evaluate and
approve, in writing, the proposed alterations prior to their
implementation. The process authority can approve only alterations that
result in the continued production of product meeting applicable
performance standards. Prior to the commercial release of any product
produced by approved, altered procedures, the establishment must
validate the altered process schedule by sampling and testing product
in accordance with a statistically valid sampling program designed by
the process authority; the tested product must meet applicable
performance standards.
(f) Example. An establishment may produce uncured meat patties
using the processes described in this example, which meet the
applicable performance standards listed in paragraph (a) of this
section.
(1) Definitions. For purposes of Sec. 318.23, the following
definitions shall apply:
(i) Comminuted. A processing term describing the reduction in size
of pieces of meat, including chopping, flaking, grinding, or mincing,
but not including chunking or sectioning.
(ii) Heat-processed. Treatment by a heat source, including, but not
limited to, frying, broiling, baking, or roasting, which results in a
fully-cooked, partially-cooked, or char-marked product.
(iii) Patty. A shaped and formed, comminuted, flattened cake of
meat food product.
(2) Processing procedures for heat-processed patties. Fully-cooked,
partially-cooked, or char-marked patties shall be processed as follows:
(i) Heat processing. (A) Official establishments which manufacture
fully-cooked patties shall utilize the following heat-processing
procedures:
Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked
Patties
------------------------------------------------------------------------
Minimum internal temperature at the center of each Minimum holding
patty time after
------------------------------------------------------ maximum
temperature is
reached
Degrees Fahrenheit Degrees Centigrade ------------------
Minutes Seconds
------------------------------------------------------------------------
151.............................. 66.1.............. 0.68 41
152.............................. 66.7.............. .54 32
153.............................. 67.2.............. .43 26
154.............................. 67.8.............. .34 20
155.............................. 68.3.............. .27 16
156.............................. 68.9.............. .22 13
157 (and up)..................... 69.4 (and up)..... .17 10
------------------------------------------------------------------------
(B) Official establishments which manufacture partially-cooked
patties
[[Page 19576]]
shall raise the internal temperature at the center of each patty to a
minimum internal temperature of 140 degrees F. and then cool it to a
maximum internal temperature of 40 degrees F. within 2 hours.
(C) Official establishments which manufacture char-marked patties
(if marked by a heat source) may raise the temperature at the center of
each patty, but not above 70 degrees F., when the char-marks are
applied to the patty. The process of char-marking the patty and cooling
the patty to a maximum internal temperature of 40 degrees F. shall be
completed within 2 hours or less.
(D) The official establishment shall measure the holding time and
temperature of at least one heat-processed patty from each production
line each hour of production to assure control of the heat process. The
temperature measuring device shall be accurate within 1 degrees F.
(ii) Cooling. (A) Fully-cooked patties shall be cooled to an
internal temperature of 40 degrees F. or below within 2 hours after
heat-processing.
(B) Cooling requirements for partially-cooked and char-marked
patties are combined with those for heat-processing and are contained
in paragraph (f)(2)(i) (B) and (C) of this section.
(C) The internal temperature measuring device shall be accurate
within 1 degrees F.
(iii) Cooking instruction label requirement. (A) Partially-cooked
patties shall bear the labeling statement ``Partially-cooked: For
Safety Cook Until Well Done (Internal Meat Temperature 160 degrees
F.)''. The labeling statement shall be adjacent to the product name, at
least one-half the size of the largest letter in the product name, and
prominently placed with such conspicuousness (as compared with other
words, statements, designs or devices in the labeling) as to render it
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
(B) Char-marked patties shall bear the labeling statement
``Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal
Meat Temperature 160 degrees F.)''. The labeling statement shall be
adjacent to the product name, at least one-half the size of the largest
letter in the product name, and prominently placed with such
conspicuousness (as compared with other words, statements, designs or
devices in the labeling) as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(iv) Sanitary handling and storage practices. Fully-cooked patties
shall be handled in accordance with the following provisions so as to
assure that the patties are not recontaminated.
(A) To prevent direct contamination of fully-cooked patties,
official establishments shall:
(1) Physically separate areas where unpackaged, fully-cooked
patties are handled from areas where less-than-fully-cooked products
are handled using a solid impervious floor to ceiling wall;
(2) Handle unpackaged, fully-cooked patties and less-than-fully-
cooked product at different times, and cleaning the entire area after
handling other products before handling unpackaged, fully-cooked
patties; or
(3) Submit a written procedure through the inspector-in-charge to
the Regional Director detailing the steps to be taken which would avoid
recontamination of fully-cooked patties by less-than-fully-cooked
product during processing.
(B) To prevent indirect contamination of fully-cooked patties:
(1) Any work surface, machine, or tool which contacts other product
shall be cleaned and sanitized before it contacts unpackaged fully-
cooked patties. The sanitizer shall be germicidally equivalent to 50
ppm chlorine.
(2) Employees shall wash their hands with soap and water and
sanitize their hands whenever they enter the fully-cooked patty area or
before handling unpackaged, fully-cooked patties. They must also wash
and sanitize their hands whenever they become contaminated during
operations to avoid contamination of fully-cooked patties. The
sanitizer shall be germicidally equivalent to 50 ppm chlorine.
(3) All employee outer garments, including aprons, smocks, and
gloves shall be identified as restricted for use in the fully-cooked
area only. The employee shall change garments at least daily. The
garments shall be hung in a designated location before the employee
leaves the area.
(C) Fully-cooked patties stored in the same room with other
product, shall first be packaged or covered to prevent microbial
contamination.
(D) Fully-cooked, partially-cooked, and char-marked patties shall
be stored at a chamber temperature of 40 degrees F. or below.
(3) Requirements for Handling Heating or Cooling Deviations.
(i) If for any reason a heating or cooling deviation has occurred,
the official establishment shall investigate and identify the cause;
take steps to assure that the deviation will not recur; and place on
file in the official establishment, available to any duly authorized
representative of the Secretary, a report of the investigation, the
cause of the deviation, and the steps taken to prevent recurrence; and
(ii) In addition, in the case of a heating deviation, the official
establishment may reprocess the affected product, by a method in
paragraph (f)(2)(i)(A) in this section; use the affected product as an
ingredient in another product processed to one of the temperature and
time combinations in paragraph (f)(2)(i)(A) in this section, provided
this does not violate the final product's standard of composition,
upset the order of predominance of ingredients, or perceptibly affect
the normal product characteristics; or relabel the affected product as
a partially-cooked patty product, if it meets the partially-cooked
requirements in paragraph (f)(2)(i)(B) of this section.
(iii) In addition, in the case of a cooling deviation, contact the
Regional Director to determine the disposition of the product.
PART 320--RECORDS, REGISTRATION, AND REPORTS
8. The authority citation for part 320 would be revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 320.1 [Amended]
9. In Sec. 320.1, paragraph (b)(4), the phrase ``Sec. 318.17(d)''
would be removed and the phrase ``Sec. 318.17(e)(4)'' would be added in
its place.
Sec. 320.4 [Amended]
10. In Sec. 320.4, the first sentence would be amended by adding
the phrase ``process schedules,'' immediately before the phrase
``facilities and inventory''
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
11. The authority citation for part 381 would be revised to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
12. Section 381.1 would be amended by adding new paragraphs (b)(63)
and (b)(64) to read as follows:
Sec. 381.1 Definitions.
* * * * *
(b) * * *
(63) Process schedule. A process schedule is a written description
of processing procedures, consisting of any number of specific,
distinct, and ordered operations directly under control of the
establishment employed in the manufacture of a specific product,
including the control, monitoring,
[[Page 19577]]
validation, and corrective action activities associated with
production.
(64) Process authority. A person or organization with expert
knowledge in poultry production process control and relevant
regulations.
* * * * *
Sec. 381.125 [Amended]
13. In Sec. 381.125, the introductory text of paragraph (b) would
be amended by removing the phrase ``Sec. 381.150(b)'' and by adding the
phrase ``Sec. 381.150(f)(2)(i)'' in its place; and by removing the word
``further''.
14. Section 381.150 would be revised to read as follows:
Sec. 381.150 Requirements for the production of cooked poultry
products and partially cooked poultry breakfast strips.
(a) Cooked poultry products must be produced using processes
ensuring that the products meet the following performance standards:
(1) Lethality. A 7-decimal log reduction of Salmonella must be
achieved within the product. The lethality process must include a
cooking step.
(2) Stabilization. There can be no germination and multiplication
of toxigenic microorganisms such as Clostridium botulinum, and no more
than a 1-decimal log multiplication of Clostridium perfringens within
the product.
(3) Handling. There can be no recontamination of product by
infectious pathogens at any time from processing through the final
packaging.
(b) Partially cooked poultry breakfast strips must be produced
using processes ensuring that the products meet the performance
standard listed in paragraph (a)(2) of this section. Labeling for these
products must comply with section 381.125. In addition, the statement
``Partially Cooked: For Safety, Cook Until Well Done'' must appear on
the principal display panel in letters no smaller than \1/2\ the size
of the largest letter in the product name. Detailed cooking
instructions shall be provided on the immediate container of the
products.
(c) For each product produced using a process other than the
process described in paragraph (f) of this section or a process
conducted in accordance with the Hazard Analysis and Critical Control
Point (HACCP) system requirements, an establishment must develop and
have on file, available to FSIS, a process schedule, as defined in
Sec. 381.1. Each process schedule must be approved, in writing, by a
process authority for safety and efficacy in meeting the performance
standards established for the product in question. A process authority
must have access to an establishment in order to evaluate and approve
the safety and efficacy of each process schedule.
(d) Establishments must validate the process schedule by producing
and testing product against applicable performance standards, in
accordance with a statistically valid sampling program designed by the
process authority. No product can be released for commercial use until
samples are tested and found to meet the applicable performance
standards. After a process authority has approved an establishment's
process schedule and before the production of lots to be held and
tested, the establishment must notify FSIS that it is implementing a
process other than that described in paragraph (f) of this section.
(e) Should an establishment wish to alter any procedures contained
in an approved process schedule, a process authority must evaluate and
approve, in writing, the proposed alterations prior to their
implementation. The process authority can approve only alterations that
result in the continued production of product meeting applicable
performance standards. Prior to the commercial release of any product
produced by approved, altered procedures, the establishment must
validate the altered process schedule by sampling and testing product
in accordance with a statistically valid sampling program designed by
the process authority; the tested product must meet applicable
performance standards.
(f) Example. An establishment may produce partially cooked poultry
breakfast strips and cooked poultry products using the processes
described in the following example, which meet the applicable
performance standards listed in paragraph (a) of this section.
(1) Poultry breakfast strips are cured and smoked products which
require special handling during distribution and additional cooking
before consumption. These products shall be heated to an internal
temperature of 140 degrees F. After heating in the establishment, these
products must be cooled to 80 degrees F. within 1.5 hours and to 40
degrees F. with 5 hours. Labeling for these products shall comply with
Sec. 381.125. In addition, the statement ``Partially Cooked: For
Safety, Cook Until Well Done'' shall appear on the principal display
panel in letters no smaller than \1/2\ the size of the largest letter
in the product name. Detailed cooking instructions shall be provided on
the immediate container of the products.
(2) Except for product produced in accordance with paragraph (f)(1)
of this section, poultry rolls and other poultry products produced in
accordance with this example shall meet the following requirements:
(i) Heat processing. Poultry rolls and other poultry products that
are heat processed in any manner shall reach an internal temperature of
at least 160 degrees F. prior to being removed from the cooking medium,
except that cured and smoked poultry rolls and other cured and smoked
poultry products shall reach an internal temperature of at least 155
degrees F. prior to being removed from the cooking medium.
Notwithstanding the other provisions of this section, product to which
heat will be applied incidental to a subsequent processing procedure
may be removed from the media for such processing provided it is
immediately fully cooked to the required 160 degrees F. internal
temperature.
(ii) Cooling. After heating in the establishment, these products
must be cooled to 80 degrees F. within 1.5 hours and to 40 degrees F.
with 5 hours.
(iii) Handling. The product must be so handled as to assure that
the cooked product is not recontaminated. To prevent direct
contamination of the cooked product, establishments shall:
(A) Physically separate areas where raw product is handled from
areas where exposed cooked product is handled, using a solid impervious
floor to ceiling wall.
(1) Handle raw and exposed cooked product at different times, with
a cleaning of the entire area after the raw material handling is
completed and prior to the handling of cooked product in that area; or
(2) Submit a written procedure for approval through the inspector-
in-charge to the Circuit Supervisor detailing the steps to be taken
which would avoid recontamination of cooked product by raw product
during processing.
(B) To prevent indirect contamination of cooked product:
(1) Any work surface, machine, or tool which contacts raw product
shall be thoroughly cleaned and sanitized with a solution germicidally
equivalent to 50 ppm chlorine before it contacts cooked product;
(2) Employees shall wash their hands and sanitize them with a
solution germicidally equivalent to 50 ppm chlorine whenever they enter
the heat processed product area or before preparing to handle cooked
product, and as frequently as necessary during operations to avoid
product contamination; and
[[Page 19578]]
(3) Outer garments, including aprons, smocks, and gloves, shall be
especially identified as restricted for use in cooked product areas
only, changed at least daily, and hung in a designated location when
the employee leaves the area.
(C) Cooked product shall not be stored in the same room as raw
product unless it is first packaged in a sealed, water-tight container
or is otherwise protected by a covering that has been approved, upon
written request, by the Circuit Supervisor.
Done in Washington, DC: April 29, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-10796 Filed 5-01-96; 8:45 am]
BILLING CODE 3410-DM-P
