Performance Standards for the Production of Certain Meat and Poultry Products

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