This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

19564

Vol. 61, No. 86

Thursday, May 2, 1996

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

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

[Docket No. 95–033P]

Performance Standards for the

Production of Certain Meat and Poultry

Products

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Proposed rule.

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-andcontrol 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-andcontrol 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.
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19565

The conversion of command-andcontrol 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 FSISestablished 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-andcontrol 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

(CCP—s) 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-toeat 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 °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 °F within 1.5

hours and to 40 °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
19566 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

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-andcontrol 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
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 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 inplant 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 authorityapproved, 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

(§ 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
19568 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

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-toeat 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 § 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 § 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 § 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

§ 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 § 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
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 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 § 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, sporeforming 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 °F to 55 °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 °F. Section

318.23(b) requires that cooked meat

patties be cooled to an internal

temperature of 40 °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,

§ 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

°F within 1.5 hours, and to 40 °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 § 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.
19570 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

Section 381.150 of the regulations

contains no specific handling

requirements for cooked poultry

products. FSIS is proposing to amend

the regulations contained in § 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 § 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 °F within 2

hours following partial cooking. Section

318.23, paragraph (b)(1)(iii) requires that

char-marked meat patties be charmarked and then cooled to a maximum

internal temperature of 40 °F within 2

hours. Section 381.150, paragraph (a)

requires that following partial cooking,

partially cooked poultry breakfast strips

be cooled to 80 °F within 1.5 hours and

to 40 °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 charmarked 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 charmarked meat patties and partially

cooked poultry breakfast strips.

Miscellaneous

Section 317.2, paragraph (l) and

§ 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

§§ 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 § 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.
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 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

§ 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 §§ 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
19572 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

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 § 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:

§ 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 § 317.2, paragraph (l) would be

revised to read as follows:

§ 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
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19573

Combination For Cooked Beef, Roast

Beef, and Cooked Corned Beef in

§ 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 § 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:

§ 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 § 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 after

minimum

temperature is

reached

Degrees Fahrenheit

Degrees

Centigrade

130 ............................ 54.4 121

131 ............................ 55.0 97

132 ............................ 55.6 77

TABLE FOR TIME/TEMPERATURE COMBINATION FOR COOKED BEEF,

ROAST BEEF, AND COOKED CORNED

BEEF—Continued

Minimum internal temperature Minimum

processing time

in minutes after

minimum

temperature is

reached

Degrees Fahrenheit

Degrees

Centigrade

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
19574 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

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
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19575

prior to the handling of cooked product

in that area; or

(iii) Submit a written procedure for

approval through the inspector-incharge 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:

§ 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, Charmarked: 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

§ 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

§ 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 heatprocessed 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 patty

Minimum holding

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
19576 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

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 heatprocessed 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 partiallycooked 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, Charmarked: 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-thanfully-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 fullycooked 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.

§ 320.1 [Amended]

9. In § 320.1, paragraph (b)(4), the

phrase ‘‘§ 318.17(d)’’ would be removed

and the phrase ‘‘§ 318.17(e)(4)’’ would

be added in its place.

§ 320.4 [Amended]

10. In § 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:

§ 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,
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 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.

* * * * *

§ 381.125 [Amended]

13. In § 381.125, the introductory text

of paragraph (b) would be amended by

removing the phrase ‘‘§ 381.150(b)’’ and

by adding the phrase ‘‘§ 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:

§ 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

§ 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 § 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-incharge 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
19578 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

(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, watertight 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

9 CFR Parts 304, 308, 317, 318, 319,

and 381

[Docket No. 95–032P]

RIN 0583–AB93

Elimination of Prior Approval

Requirements for Establishment

Drawings and Specifications,

Equipment, and Certain Partial Quality

Control Programs

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Proposed rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is proposing

to amend the Federal meat and poultry

products inspection regulations by

removing current requirements for prior

approval by FSIS of establishment

drawings, specifications, and equipment

prior to their use in official

establishments. Requirements involving

the comparison of blueprints and

specifications with actual facilities and

equipment would end. These

amendments would provide the

regulated industry with the flexibility to

design facilities and equipment in the

manner they deem best to maintain a

sanitary environment for food

production. FSIS would continue to

verify through inspection that good

sanitation is being achieved. Similarly,

FSIS is proposing to end its prior

approval of most establishmentoperated partial quality control

programs, which are used by

establishments to control certain kinds

of food processing and product

characteristics. This change would make

it possible for establishments to develop

and implement quality control programs

without first having to receive

permission from FSIS to do so. This

action is being taken to streamline and

modernize the meat and poultry food

safety regulations, to separate the roles

of Government and the regulated

industry, to encourage innovations that

will improve food safety, and to remove

unnecessary regulatory burdens on

inspected meat and poultry

establishments. In addition, the

proposal represents an important shift

away from FSIS’s ‘‘command-andcontrol’’ regulatory approach and

toward a less bureaucratic approach

consistent with the Agency’s food safety

mission.

DATES: Comments must be received on

or before: July 1, 1996.

ADDRESSES: Please send an original and

two copies of comments on this

proposed rule to FSIS Docket Clerk,

DOCKET #93–032P, Room 4352 South

Agriculture Building, Washington, DC

20250–3700. Oral comments, as

provided under the Poultry Products

Inspection Act, should be directed to

the person listed under FOR FURTHER

INFORMATION CONTACT. Copies of FSIS

reference materials cited in this

proposal are available for review in the

FSIS docket room.

FOR FURTHER INFORMATION CONTACT: Ms.

Patricia F. Stolfa, Acting Deputy

Administrator, Science and Technology,

FSIS, Room 402 Annex Building,

Washington, DC 20250–3700; (202) 205–

0699.

SUPPLEMENTARY INFORMATION:

Background

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.) direct the

Secretary of Agriculture to maintain

inspection programs designed to assure

the public that meat and meat food

products (meat products) and poultry

and poultry products (poultry products)

are safe, wholesome, not adulterated,

and properly marked, labeled, and

packaged. FSIS carries out the mandates

of these statutes by administering a

continuous in-establishment inspection

program for meat and poultry products

that are shipped in interstate and

foreign commerce or in ‘‘designated’’

States. A number of the States operate

meat and poultry inspection programs

for product shipped intrastate. Under

the FMIA and PPIA, such programs

must impose requirements ‘‘at least

equal’’ to the Federal requirements.

The FMIA and PPIA require the

Secretary to provide, among other

things, for the inspection of

establishments to assure that the

conditions under which meat and

poultry products are produced are

sanitary. The Acts also require the

Secretary to prescribe rules and

regulations governing the sanitary

conditions of official establishments (21

U.S.C. 608 and 456). Pursuant to these

provisions, the meat and poultry

inspection regulations currently

prescribe ‘‘prior approval’’ or approvalbefore-use by FSIS of facility drawings

and specifications and of equipment

used in official establishments. The

regulations also provide for the prior

approval of certain quality control

programs, known as partial quality

control (PQC) programs, before their use

by official establishments.

Current Prior Approval Procedures

Currently, applicants seeking Federal

inspection must submit to FSIS

blueprints and drawings with

specifications that exactly illustrate the

applicant’s establishment as it exists or

is proposed to exist (9 CFR 304.2(a),

308.2, and 381.19). Before inspection is

granted, FSIS officials in the field and

in Washington, D.C., review the

blueprints and drawings and the facility

they represent to determine whether the

facility meets the requirements of the

meat and poultry inspection regulations,

which are intended to ensure that

products can be produced in a sanitary

environment. Owners or operators of

establishments intending to add

structures or remodel their existing

facility must also submit blueprints and

drawings with specifications to FSIS for

review before beginning any new

construction (9 CFR 404.2, 308.2, and

381.19). During FY 1994, FSIS technical

personnel reviewed about 2,900 sets of

blueprints for new or modified facilities.

Federally inspected establishments or

equipment manufacturers must go

through a similar process of prior

submission for review and approval of

most equipment used in preparing or

handling edible meat and poultry

products or ingredients (9 CFR 308.5

and 381.53). FSIS requires that

establishment owners or operators

wishing to use new equipment submit

any information FSIS needs to review

new equipment, including assemblytype drawings and a list showing the

materials of which parts are made. The

primary objectives of the FSIS review

are to determine whether the equipment

can be readily cleaned and inspected for

its sanitary condition. In some

instances, FSIS also requires that the

equipment be used on a trial basis

before approval is granted (9 CFR

308.5(d) and 381.53(a)(4)). FSIS

technical personnel review more than

2,500 submissions of equipment

specifications each year, and

approximately 650 pieces of new

equipment require a trial installation

before being accepted for use.