This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

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REGISTER issue of each week.

Rules and Regulations Federal Register

34381

Vol. 65, No. 104

Tuesday, May 30, 2000

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317, 318, 319, 381, and 424

[Docket No. 97–001F]

RIN 0583–AC35

Elimination of Requirements for Partial

Quality Control Programs

AGENCY: Food Safety and Inspection

Service.

ACTION: Final rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is amending

the meat and poultry products

inspection regulations by removing the

remaining requirements pertaining to

partial quality control (PQC) programs.

A PQC program controls a single

product, operation, or part of an

operation in a meat or poultry

establishment. FSIS is removing the

design requirements for PQC programs

and the requirements for establishments

to have PQC programs for certain

products or processes. For example,

poultry slaughtering establishments

operating under the New Line Speed

(NELS) inspection system and the New

Turkey Inspection System (NTIS) will

no longer be required to operate PQC

programs in conjunction with those

systems. FSIS also is removing from the

thermal processing regulations all

requirements concerning PQC programs,

the requirements for case-by-case FSIS

approval of systems and devices not

specified in the regulations, and several

other prior approval requirements. The

amended regulations will be more

consistent with the Pathogen Reduction

(PR)/Hazard Analysis and Critical

Control Points (HACCP) regulations and

inspected establishments will have

greater flexibility to adopt new

technologies and methods that will

improve food safety and other consumer

protections.

EFFECTIVE DATE: August 28, 2000. The

material incorporated by reference is

approved by the Director of the Federal

Register as of August 28, 2000.

FOR FURTHER INFORMATION CONTACT: Dr.

Daniel L. Engeljohn, Director,

Regulations Development and Analysis

Division, Office of Policy, Program

Development, and Evaluation, Food

Safety and Inspection Service, U.S.

Department of Agriculture, Washington,

DC 20250–3700; (202) 720–5627.

SUPPLEMENTARY INFORMATION:

Background

FSIS carries out programs designed to

ensure that meat, poultry, and egg

products are wholesome, not

adulterated, and properly marked,

labeled, and packaged. FSIS is

implementing the ‘‘Pathogen Reduction;

Hazard Analysis and Critical Control

Point (HACCP) Systems’’ final rule

published July 25, 1996 (61 FR 38806),

to reduce the risk of foodborne illness

associated with the consumption of

meat and poultry products to the

maximum extent possible. The Pathogen

Reduction (PR)/HACCP final rule

requires establishments to take

appropriate and feasible measures to

prevent or reduce the likelihood of

physical, chemical, and microbiological

hazards in the production of meat and

poultry products. Specifically, the PR/

HACCP final rule: (1) Requires each

official meat and poultry establishment

to develop and implement written

sanitation standard operating

procedures (Sanitation SOP’s); (2)

requires regular microbial testing (for

generic Escherichia coli) by slaughter

establishments to verify the adequacy of

the establishment’s process controls for

the prevention and removal of fecal

contamination and associated bacteria;

(3) establishes pathogen reduction

performance standards for Salmonella

that slaughter establishments producing

raw ground products must meet; and (4)

requires that all meat and poultry

establishments develop and implement

a system of preventive controls designed

to improve the safety of their products,

known as HACCP.

HACCP is a conceptually simple,

science-based process control system by

which food processors identify and

evaluate hazards to the production of

safe products, institute controls

necessary to reduce or eliminate those

hazards, monitor the performance of

these controls, and maintain records of

this monitoring.

FSIS is reviewing its regulations to

determine how they can be revised to

conform with the PR/HACCP

regulations and the regulatory approach

they embody. This approach favors

performance-based standards over

prescriptive, command-and-control

regulations. In its December 29, 1995,

advance notice of proposed rulemaking

(ANPR) ‘‘FSIS Agenda for Change:

Regulatory Review’’ (60 FR 67469), FSIS

said that by eliminating unnecessary

regulations and replacing commandand-control prescriptions with

performance standards, inspected

establishments would have greater

flexibility to adopt innovations that can

yield food safety benefits. Identified as

candidates for modification or

elimination were those regulations that

delimit processing and treatment

methods intended to address specific

food safety hazards and requirements

that establish quality control programs.

Under FSIS regulations, a company

may choose to place all of the processes

and products in a plant under a

comprehensive, or total, quality control

(TQC) system, or the company may

choose to place only individual

products or processes under quality

control. A quality control program for

only one process or product in a plant

is known as a partial quality control, or

PQC, program. This final rule addresses

PQC programs.

Some PQC programs control potential

health and safety problems; others focus

on economic or quality factors. PQC

programs controlling for safety factors

include those for thermally processed

products, which are intended primarily

to prevent toxin formation in the

processed product. The programs for

cooked beef products are intended to

ensure that the processing of the

products meets the regulatory

requirements for handling, processing

(time, temperature, and relative

humidity), and storage to prevent

pathogen formation in the products.

PQC programs that control for product

safety have been superseded by required

HACCP plans.

PQC programs that control for

economic or non-food safety factors

include those used to control the fat and

water content of hotdogs; the number of

34382 Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations

meatballs in or pepperoni slices on, a

product; and the moisture or protein-fatfree (PFF) content of a product labeled

‘‘ham, water added.’’ The quality

control program for mechanically

separated (species) (MS(S)) is intended

to control bone particle size, calcium

content, fat and protein content, and

protein efficiency ratio (9 CFR 319.5).

The programs for pressed ham and

spiced ham products are intended to

ensure that the products meet the PFF

regulatory requirements of § 319.104.

PQC programs to control products for

economic factors are intended to

prevent the marketing of products that

are misbranded or that lack the quality

or value that consumers expect. A plant

operating under a PQC program for net

weight keeps records of its checks and

corrective actions to avoid lot

inspection. Under PQC programs for fat

and water in frankfurters, plants keep

ingredient records by lot and results of

laboratory tests for verification by FSIS

inspectors. A plant operating a PQC

program for boneless meat inspection

does its own on-line inspection and

keeps records. The FSIS inspector

randomly selects samples of product

that the plant has already inspected to

ensure that the records are accurate.

FSIS regulations have required

establishments to have PQC programs

for certain products or processes, such

as the one for MS(S), just mentioned. A

PQC program for on-line carcass quality

control has been required for an

establishment operating under either the

NELS or the NTIS poultry inspection

system (9 CFR 381.76(c)).

In 1997, the Agency published a final

rule that, among other things, removed

the requirement for FSIS prior approval

of most PQC programs (62 FR 45016;

August 25, 1997). FSIS now thinks it

appropriate to take the further step of

eliminating the remaining PQC

requirements so that establishments will

have the flexibility they need to be

innovative, consistent with HACCP and

the Agency’s regulatory policy.

On May 18, 1999, FSIS proposed to

amend the meat and poultry products

inspection regulations by removing

requirements pertaining to PQC

programs, except programs for poultry

product irradiation plants (64 FR

26892). The December 23, 1999, final

rule ‘‘Irradiation of Meat Food

Products’’ removed requirements for

quality control programs in such

irradiation plants (64 FR 72165).

Comments Received

FSIS received six letters in response

to the May 18, 1999, proposal. All were

from the regulated industry and all

supported the proposal. Some

commenters wanted clarification of

matters addressed in the preamble of the

proposal, and one requested the removal

of additional regulatory restrictions. The

substantive comments and the Agency’s

responses are summarized below.

Comment: An organization

representing the food processing

industry supported the proposed

removal from the thermal processing

regulations of requirements for FSIS

prior approval of systems and devices

not specified in the regulations and of

all requirements concerning PQC

programs. This commenter also

recommended the removal from these

regulations of additional command-andcontrol provisions. The commenter

asked that, in the regulations on the

handling of containers after closure (9

CFR 318.301(f)(2) and 381.301(f)(2)),

approval by a processing authority

replace the need to obtain the FSIS

Administrator’s permission for a time

lapse between container closing and

initiation of thermal processing of

greater than two hours.

Response: FSIS set the regulatory

maximum 2-hour time period between

container closure and initiation of the

thermal process in its 1984 canning

regulation amendments. The Agency

did so to prevent adulteration from the

holding of unprocessed products for an

extended period, and because it was

aware of several documented incidents

of illness from staphylococcal

enterotoxin in such products. The

commenter’s suggested change would

place the judgment whether to alter the

specified time interval between closure

and the initiation of thermal processing

with the process authority rather than

the FSIS Administrator.

A processing authority is an

individual or organization with expert

knowledge of thermal processing

requirements for foods in hermetically

sealed containers, having access to

facilities for making such

determinations, and designated by the

establishment to perform certain

functions required by the regulations.

FSIS already requires the processing

authority to perform the vital function

of developing and determining the

process schedule and specifying the

critical factors in the process.

The change suggested by the

commenter is consistent with the

Agency’s stated aim of making the meat

and poultry canning regulations more

consistent with the Agency’s new, noncommand-and-control regulatory

approach by eliminating some prior

approval requirements. With respect to

the canning regulations, however, this

rulemaking addresses only PQC

programs and prior approval

requirements other than the one

addressed by the commenter. FSIS

therefore considers the commenter’s

request to be outside the scope of this

rulemaking.

Comment: The same commenter

requested the addition to the regulations

on pH measurement in canning plants

(9 CFR 318.304(e) and 381.304(e)) of a

provision allowing use of colorimetric

or other methods in addition to

potentiometric methods, provided that

the methods are sufficiently accurate to

ensure product safety and stability. The

commenter also asked for the removal of

the requirement for approval by the

FSIS Administrator of methods other

than the potentiometric. In addition, the

commenter requested the removal of the

requirement at 9 CFR 318.305(h)(2) and

381.305(h)(2) for approval by the FSIS

Administrator for the use in cooling

canal water of chemicals other than

chlorine that have a bactericidal effect

equivalent to that of chlorine.

Response: As stated in the previous

response, FSIS proposed to make the

thermal processing regulations more

consistent with its new regulatory

approach by eliminating provisions

concerning PQC programs and certain

prior approval requirements. FSIS did

not propose changes in its requirements

for pH measuring devices or chemicals

used in cooling canal water. These

suggested changes are outside the scope

of this rulemaking, and, accordingly,

FSIS is not making them in this final

rule.

Regarding the regulation on chemicals

in cooling canal water, FSIS announced

in early 1998 that it was ending its prior

approval system for all non-food

compounds and proprietary substances

(63 FR 7319; February 13, 1998). These

classes of substances include water

treatment compounds. The program was

ended because the Agency considered it

to be redundant with those of other

Federal agencies and because of the

program’s inconsistency with the PR/

HACCP regulations.

Since establishments are responsible

for developing and implementing

HACCP plans incorporating the controls

necessary and appropriate to produce

safe meat and poultry products, FSIS is

not responsible for determining whether

the nonfood compounds and proprietary

substances they use are safe and

effective. Therefore, establishments

need not obtain the approval of the

Administrator to use chemicals other

than chlorine in cooling canal water.

Nevertheless, FSIS retains the

discretionary authority to prevent the

use of such substances in official

establishments if the Agency finds,

through its normal inspection activities,

Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations 34383

that the substances directly or indirectly

contaminate edible product. FSIS

expects establishments to use only

compounds that are safe and that have

the intended technical effect when used

appropriately in a food preparation

environment. The Agency expects

establishments to keep on file any

information provided by chemical

manufacturers (written approvals from

other agencies, letters of guaranty, etc.)

as part of their sanitation SOP, HACCP,

or other records.

Comment: The same commenter

requested the removal of two other

prior-approval requirements in the

canning regulations: first, the

requirement (in 9 CFR 318.305(a)(2)(ii)

and 381.305(a)(2)(ii))for FSIS

Administrator approval of recording

devices other than temperature/time

recording devices; and second, the

requirement at 9 CFR 318.305(d)(5) and

381.305(d)(5) that the FSIS

Administrator be notified of the use of

any batch retorts with steam/air

circulation systems.

Response: FSIS proposed the

elimination of the requirement for priorapproval of thermometric measuring

devices other than mercury-in-glass

thermometers (proposed

§§ 318.305(a)(1)(ii) and

381.305(a)(1)(ii)). The Agency also

proposed the elimination of prior

approval requirements for automated

process monitoring and recordkeeping

systems not specified in the canning

processing regulations (proposed

§§ 318.307(b) and 381.307(b)). The

commenter’s suggestion to remove the

requirement in §§ 318.305(a)(2)(ii) and

381.305(a)(2)(ii) for prior approval of

time/temperature recording devices

other than chart-type devices is

consistent with the Agency’s proposals

regarding temperature measurement and

automatic process monitoring devices.

Accordingly, FSIS is making the

requested change to the regulations in

this final rule.

Regarding the prior approval of batch

retorts with steam-air cooling, FSIS

finds the commenter’s request to be

consistent with the Agency’s proposal to

eliminate the requirement for prior

approval of thermal processing systems

other than those delineated in

§§ 318.305 and 381.305 of the canning

regulations (proposed §§ 318.305(f) and

381.305(f)). FSIS is therefore adopting

the requested change in this final rule.

Comment: The same commenter—the

organization representing the food

processing industry—questioned the

intent of the Agency’s statement in the

preamble of the proposal regarding

alternative documented procedures for

handling process deviations or finished

product inspections. FSIS stated, at 64

FR 26894, that such procedures ‘‘would

have to ensure that only safe, stable

product is shipped in commerce.’’ The

procedures would have to ensure that

the product is free of microorganisms of

public health significance and is not

adulterated by other types of bacteria,

such as ‘‘flat-sour’’ bacteria or other

spoilage organisms.

The commenter thought that the

Agency’s statement could be

misinterpreted to mean that a product

might be adulterated if spoilage

organisms were merely present in a

product not likely to be subject to

conditions that would lead to the

growth of the organisms and

deterioration of the product. Citing the

regulatory definition of shelf stability (at

9 CFR 318.300 and 381.300), the

commenter pointed out that the

presence in low numbers of flat-sour

bacteria or other spoilage organisms that

would not grow under intended

conditions of distribution and storage

would not render the product

adulterated. However, the growth of

spoilage organisms to high numbers that

affected product characteristics before

or after processing would adulterate the

finished product. The product then

would not be cleared by a processing

authority or released into commerce.

Response: The commenter has

accurately explained the intended

meaning of the phrase ‘‘adulterated by

* * * spoilage organisms’’ in the

preamble of the proposal (at 64 FR

26894). In stating the conditions for use

of procedures alternative to the existing

prescriptive requirements (9 CFR

318.308(d) and 381.308(d); 9 CFR

318.309(d) and 381.309(d)), FSIS

assumed the current regulatory

definitions of ‘‘shelf stability.’’

Comment: The same commenter

questioned whether the Agency’s

example of an establishment’s

incorporation of a PQC program for raw

materials in the establishment’s HACCP

plan (at 64 FR 26896) might imply that

non-food safety regulatory concerns

might become part of HACCP systems,

which only address food safety issues.

Response: FSIS agrees with the

commenter that HACCP systems are

only intended to control food safety

hazards. The Agency recognizes the

potential for misunderstanding that can

arise when PQC programs and HACCP

systems are discussed because PQC

programs may address either safety or

quality issues or both. The context of

the statements to which the commenter

refers was the analysis of benefits of the

rule. One benefit to establishments is a

possible efficiency gain through

integration of some facets of quality

control with HACCP. FSIS meant to

suggest by its example that a food

safety-related PQC program or other

food safety process control could be

used in the context of an

establishment’s HACCP plan. The

HACCP plan would include a critical

control point for raw materials only if

the hazard analysis identified a food

safety hazard associated with raw

materials. Raw material control is

identified as a CCP in many HACCP

plans and is not so identified in others.

A PQC program for raw materials or any

other step in processing a product

would be relevant to HACCP and be

subject to being subsumed in or

superseded by a HACCP plan only if it

were food safety-related.

Comment: The food-processing

industry organization also read

proposed § 318.308(b)(2) and

§ 381.308(b)(2) as inadvertently

depriving very small establishments of

the option of using the alternative

procedures for handling process

deviations (§ 318.308(d) and

§ 381.308(d)).

Response: The proposal language did

not exclude any canning establishment

without a HACCP plan that addresses

microbial hazards from using the

procedures in paragraph (d) of § 318.308

or § 381.308. Further, under the final

rule, these procedures will continue to

be available to establishments whose

HACCP plans do not address microbial

hazards.

Comment: Three of the commenters—

the food-processing industry

organization, an organization

representing the Nation’s turkey

industry, and a producer of processed

meat and poultry products—wanted

FSIS to continue to recognize the value

of PQC programs, and particularly of

those programs that the Agency has

previously approved. The foodprocessing industry organization

expressed concern that such programs

might automatically become invalid

when the final rule goes into effect. The

organization wanted the Agency to

address this matter in implementing

notices or directives to the FSIS field

force lest previously approved

procedures have to be re-documented.

Response: FSIS has not changed its

policy of encouraging establishments to

adopt statistically sound quality control

systems. FSIS recognizes, however, that

product formulations, processing

operations, and technology may change

over time, and that establishments

should have the ability to change the

variables and parameters of their control

programs without seeking Agency

revalidation of those programs. The

Agency is therefore removing the

34384 Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations

prescriptive, command-and-control

regulatory requirements that may inhibit

innovation—especially innovation that

may yield food safety benefits. The

Agency’s approval process for PQC

programs was part of that old commandand-control system.

Obviously, a PQC program that the

Agency approved in the past may still

be regarded as useful if no significant

changes have been made in the process

or product controlled. However, the

proof of the program’s effectiveness

must be found primarily in the data

collected under the program or other

studies of the product or process

controlled and not in an old approval

letter. This is particularly the case with

respect to food safety-related PQC

programs. Where food safety is

concerned, FSIS will be relying

primarily on its verification of HACCP

systems to determine whether official

establishments are taking sound control

measures.

Regarding the enforcement of this

final rule, FSIS will issue appropriate

instructions to its field force. Many of

the changes necessary to carry out this

final rule have already been instituted

with the revision of the Agency’s

automated system for directing

inspection program activities.

Comment: An organization

representing the meat and poultry

canning industry supported the

proposal but thought the preamble

should have expanded on how and why

the elimination of PQC programs would

not diminish consumer confidence. The

commenter thought that FSIS should

have furnished a more comprehensive

explanation of PR/HACCP for readers

unfamiliar with it, and of why and how

PR/HACCP systems make PQC programs

redundant. The commenter also thought

the explanation for the elimination of

specific PQC requirements was

insufficient to allay consumer

skepticism or fears about eliminating

such requirements. In particular, a more

substantial justification should have

been given for removing FSIS case-bycase approval of thermal processing

systems not specifically delineated in

the regulations. In this context, the

commenter thought that FSIS should

have discussed the fact that scientific

evaluation of all new processes by

competent experts is a long-established

practice of the canned food industry.

Response: FSIS made an editorial

decision to limit the explanation of the

PR/HACCP final rule and its underlying

principles because they had been fully

discussed in previous Agency

publications and at the many public

meetings and media events conducted

since 1995. The PR/HACCP final rule

and the other documents referred to in

the preamble of the proposal were made

available for public viewing in the FSIS

Docket Room at the address given in the

proposal. Nevertheless, in response to

the commenter’s suggestion, FSIS has

added, near the beginning of this

preamble, a summary of the main

features of the PR/HACCP final rule.

While FSIS may not have provided a

discussion of PR/HACCP sufficient to

satisfy the commenter, the Agency did

state in the proposal that requirements

for PQC programs that control for

product safety have been superseded by

required HACCP plans (64 FR 26893,

col. 1). The Agency also stated that

requirements pertaining to PQC

programs that control food safety factors

are inconsistent with PR/HACCP (64 FR

26894, col. 3). The Agency further stated

or implied in a number of places (64 FR

26892, col. 3; 26893, col. 3; 26894, col.

1, col. 3; 26895, col. 2, col. 3; and 26896,

col. 2) that regulatory requirements for

PQC programs tend to restrict

innovation and perpetuate the

command-and-control approach to food

inspection and regulation. Such

regulatory requirements are not in

keeping with the Agency’s new

approach of defining industry

compliance with performance-related

objectives.

On the matter of consumer protection,

the Agency stated that the proposed rule

was intended to provide inspected

establishments with flexibility and to

encourage them to adopt new

technologies and methods that will

improve food safety and other consumer

protections (64 FR 26892, 26895 col. 2).

The Agency also stated, with respect to

PQC programs required to ensure

compliance with regulatory limits on

certain restricted ingredients (64 FR

28693, col. 3) and with product

standards, that the limits and standards

themselves, as well as product labeling

requirements, would continue to protect

consumers (64 FR 26894, col. 3; 26895,

col. 1).

FSIS stated that PQC programs were

not necessary to ensure food safety

protection where HACCP plans were in

operation (64 FR 26894, col.2). It may be

that FSIS could have said more about its

regulatory provisions for continued

consumer protection, but in the

Agency’s judgment, what it said was

sufficient for the purposes of the

rulemaking.

On the elimination of case-by-case

approval of new types of thermal

processing systems in 9 CFR 318.305(f)

and 381.305(f), new systems must still

meet the applicable requirements

governing equipment and heat

processing procedures and be capable of

producing shelf-stable products

consistently and uniformly. FSIS stated

in the preamble of the proposal (at 64

FR 26894) that these requirements

reflect the basic purposes of the canning

regulations.

The canning regulations continue to

address such matters as: container

integrity before and after fill; container

closure; thermal processing schedules;

critical factors; operations in the

thermal processing area; processing and

production records; deviations in

processing; finished product standards;

recalls; and the role of the processing

authority. FSIS has recognized that the

thermal processing regulations are

HACCP-consistent with respect to the

control of microbial hazards and has

supplemented them with a requirement

for HACCP plans that address physical

and chemical hazards. The Agency also

realizes, however, that many of these

regulations are excessively prescriptive

and in its December 29, 1995, ANPR,

cited above, listed them among

candidates for revision or removal in

conjunction with HACCP

implementation.

The commenter’s statement about the

canning industry’s practice of having all

new processes evaluated scientifically

by competent experts is a point well

taken. Both the FDA and the FSIS

regulations governing thermally

processed, low-acid foods in

hermetically sealed containers require

thermal process schedules to be

established by qualified persons—

processing authorities—who have

expert knowledge of thermal processing

requirements for such foods and access

to the facilities to make the necessary

determinations (21 CFR 113.83; 9 CFR

318.302, 381.302). These requirements

remain in effect for canned products.

Also, FSIS has thought well enough of

the process-authority concept to make

use of it in the final rule ‘‘Performance

Standards for the Production of Certain

Meat and Poultry Products’’ (64 FR 732;

January 6, 1999). Under that final rule,

affected products not produced under a

HACCP plan must be produced

according to a process schedule

approved in writing by a process

authority for safety and efficacy in

meeting the performance standards

applicable to the product.

Regarding the interest commenters

have shown in the few changes in the

canning regulations to be made in this

final rule, FSIS notes that in the

December 29, 1995, ANPR cited above,

FSIS listed the requirements for canning

and canned products as candidates for

reform. Possible actions to be taken

were the conversion of these

requirements to performance standards

Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations 34385

and clarifying the role of inspection

program employees. A future

rulemaking to reform the canning

regulations remains under

consideration.

Regulation Changes Adopted

FSIS is eliminating the requirement in

9 CFR 317.21(b) that establishments

have, as an alternative to State or local

certification of scales, PQC programs or

total quality control system provisions

for checking the accuracy of scales. The

Agency will simply require that there be

a certification of accuracy from State or

local authorities or from a Stateregistered or -licensed scale repair firm

or person. Establishments can, of

course, continue to maintain scalechecking provisions in their QC

programs and systems.

The Agency is removing from the

meat and poultry inspection regulations

the design requirements for partial

quality control programs (9 CFR

§ 318.4(d), § 381.145(d)).

FSIS also is removing quality control

requirements governing the use of

nitrites in bacon curing and the use of

certain organic acids singly or in

combination to delay the discoloration

of fresh meat cuts (9 CFR 424.21–.22).

Such requirements are incompatible

with the Agency’s regulatory objectives

because they specify a manner of

compliance rather than simply a

performance standard. Both the nitrite

and the organic acid regulations clearly

state the maximum limits of use of the

substances they concern. Also, the

consumer is informed by product

labeling of the presence of the

substances in products. The regulations

provide clear limits and adequate

consumer protections without the

quality control requirements. In

addition, the Agency is improving the

accuracy of the regulation by using the

term ‘‘production of botulinum toxin’’

rather than ‘‘growth of botulinum toxin’’

(see 9 CFR 424.22(b)(1)(ii)(B)).

FSIS is eliminating a number of priorapproval requirements from the meat

and poultry canning regulations. The

Agency is replacing the requirement

that the Agency approve temperatureindicating devices other than mercuryin-glass thermometers (at

§§ 318.305(a)(1)(ii) and 381.305(a)(1)(ii))

before they could be used. The devices

must meet known standards of accuracy

for such devices, but the Agency is not

prescribing the frequency of testing for

accuracy.

The Agency is removing the

requirement for FSIS prior-approval of

the use of time/temperature recording

devices other than chart-type devices.

The alternative devices must meet

known standards of accuracy (9 CFR

318.305(a)(1)(ii) and (a)(2)(ii); 9 CFR

381.305(a)(1)(ii) and (a)(2)(ii)).

In response to comments, the Agency

is removing the requirement at 9 CFR

318.305(d)(5) and 381.305(d)(5) that the

FSIS Administrator be notified of the

use of any batch retorts with steam/air

circulation systems. As explained

previously in this document, FSIS

regards this action as consistent with

the proposed rule.

As proposed, the Agency is removing

the requirement for FSIS case-by-case

evaluation and prior approval of

systems for thermally processing canned

product other than those systems

specifically delineated in the

regulations. Such alternative systems

must still be adequate for producing

shelf-stable product consistently and

uniformly. (9 CFR 318.305(f),

381.305(f).)

FSIS is removing from the thermal

processing regulations (9 CFR

318.307(b) and 381.307(b)) requirements

for FSIS approval of automated process

monitoring and recordkeeping systems.

The Agency also is removing from the

thermal processing regulations the

requirements in §§ 318.308 and 309 and

§§ 381.308 and 309 concerning partial

quality control programs to control

process deviations and establishment

finished product inspection procedures.

The Agency finds that these

requirements are unnecessary. The

remaining provisions in these sections,

which are based on HACCP principles,

remain as acceptable protections against

potential microbial contamination.

The proposal would have provided

additional options for establishments,

such as handling the deviations under

an approved total quality control system

or using alternative documented

procedures until the PR/HACCP rule

became applicable to the establishment.

The alternative documented procedures

could have included partial quality

control programs or other documented

corrective action, monitoring, or

recordkeeping procedures developed by

or for the establishment, but not subject

to FSIS approval. Such food safetyrelated PQC programs were to be

integrated in or superseded by the

establishment’s HACCP plan. Because

the effective date of the final rule is after

January 25, 2000, however, the PR/

HACCP regulations will be applicable to

all establishments that are subject to the

final rule. Thus, there is no need to

provide options for establishments that

are not yet subject to the PR/HACCP

requirements. Deviations in processing

will need to be handled according to a

HACCP plan that addresses hazards

associated with microbial

contamination or by the alternative

procedures for handling deviations

during processing or through record

review (§§ 318.308(d) and 381.308(d)).

A thermal processing establishment

will have available at least three

alternatives for handling finished

product inspections. The finished

product inspections could be handled

under: (1) The existing regulations

(§§ 318.309(d) and 381.309(d)); (2) a

HACCP plan; or (3) alternative

documented procedures for handling

finished product inspections. The

alternative documented procedures can

be PQC programs or the HACCP plan

provisions.

In any case, any alternative

procedures for handling process

deviations or finished product

inspections will have to ensure that

only safe, stable product is shipped in

commerce. The procedures will have to

ensure that the product is free of

microorganisms of public health

significance, and that it does not contain

other types of microorganisms, such as

‘‘flat-sour’’ bacteria or other viable

spoilage organisms, that could cause

adulteration under intended conditions

of distribution and storage of the

product. This requirement is consistent

with the aims of HACCP and with the

statutory prohibitions against the

distribution of adulterated and

misbranded meat and poultry products

in commerce.

These amendments and revisions will

make the thermal processing regulations

more consistent with the PR/HACCP

final rule by explicitly providing a

HACCP-plan alternative (consistent

with §§ 417.2(b)(3)) to the prescriptive

procedures in §§ 318.309(d) and

381.309(d). The amended and revised

regulations also include, as an option

for handling process deviations or final

product inspections, alternative

documented procedures that ensure that

only safe and stable products are

shipped in commerce. This option will

provide the establishment with the

flexibility to use PQC programs or other

procedures that meet a regulatory public

health standard.

It should be noted that, under the

HACCP regulations, an establishment’s

HACCP plan does not have to address

potential microbial hazards in thermally

processed/commercially sterile product

if the establishment is following the

current regulatory requirements for such

product. However, the HACCP plan

must address physical and chemical

hazards to which the product may be

subject.

Besides removing the requirements

pertaining to PQC programs that control

food safety factors, which are

34386 Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations

inconsistent with PR/HACCP, FSIS is

removing the requirements affecting

economic or quality-related PQC

programs. FSIS considers both the food

safety-related and the economic PQC

requirements to be too prescriptive.

They tend to perpetuate the commandand-control approach to food inspection

and regulation. They are not in keeping

with the Agency’s new regulatory

approach, which is oriented more

toward monitoring industry compliance

with performance-related objectives.

FSIS is removing the QC system

requirements from the regulations and

requirements governing the identity and

composition of MS(S) product and label

approval of the product (9 CFR 319.5).

The MS(S) regulations specify the

maximum calcium content, the

minimum protein content, the protein

efficiency ratio, the maximum fat

content, and the maximum bone particle

size for the product. The regulations

also specify the elements that the QC

system must contain, including a

written description of the methods used

by the establishment to maintain

uniformity of raw materials used in

manufacturing product and to control

handling and processing of the raw

materials and finished product. The

regulations also specify the sample size

and sampling frequency for foodchemistry analysis of product to

determine compliance with the

standards. FSIS regards these provisions

as overly prescriptive and believes that,

to achieve the purposes of the MS(S)

regulations, it is sufficient to set the

product standards for fat, protein,

calcium content, and bone particle size.

The Agency also is updating the

provision for finished product samples

to be analyzed according to methods of

the Association of Official Analytical

Chemists (AOAC) or methods listed in

the FSIS ‘‘Chemistry Laboratory

Guidebook’’ to reflect use of the most

recent edition of the AOAC

compendium. In addition,

establishments will have the latitude to

use validated scientific methods

equivalent to, but not listed in, the

AOAC and FSIS references. They will

have the flexibility to choose the most

appropriate means of ensuring that

MS(S) meets the compositional and

labeling identity requirements of the

regulations. The Agency cautions,

however that, if the establishment is to

adequately protect its interests, it

should ensure that the method that it

uses will produce results comparable to

the relevant AOAC or FSIS method.

Second, FSIS is eliminating the

quality control program requirements

from the protein-fat-free (PFF)

percentage regulations (§§ 319.104 and

319.105) for various ‘‘finely divided’’

cured ham products, such as patties,

chopped or pressed ham, and spiced

ham. Establishments, however, must

continue to comply with the PFF

percentage limits for these products.

Finally, FSIS is removing the

requirement that poultry slaughtering

establishments operating under the

NELS and NTIS inspection systems

have PQC programs for carcass defects.

The establishments will now have the

flexibility to adopt quality control

programs or other measures for ensuring

the quality of their products. Removing

the prior-approval aspect of these

requirements contributes to clarifying

the respective roles of the inspection

service and the regulated industry—a

necessary task in making the

requirements consistent with HACCP.

FSIS inspectors will continue to

check poultry in NELS and NTIS plants

for visible contamination and carcass

trimming defects.

Executive Order 12866 and Regulatory

Flexibility Act

This final rule has been determined to

be significant, though not economically

significant, and was reviewed by the

Office of Management and Budget under

Executive Order 12866.

FSIS is eliminating the regulatory

requirements pertaining to

establishment-operated PQC programs.

This action removes regulatory obstacles

to innovation and command-and-control

requirements, which are inconsistent

with the Agency’s new regulatory

approach and the objectives of the PR/

HACCP regulations. In the Agency’s

August 25, 1997, final rule ‘‘Elimination

of Prior Approval Requirements for

Establishment Drawings and

Specifications, Equipment, and Certain

Partial Quality Control Programs’’ (62

FR 45016), the requirements for FSIS

prior approval of most PQC programs

were eliminated. This action was taken

to facilitate the transition to HACCP in

official establishments producing the

greatest portion of meat and poultry

products consumed in the United

States. FSIS is now taking the additional

step of eliminating the remaining

requirements for establishments to have

PQC programs for specific products or

processes, as well as design

requirements affecting PQC programs.

The alternatives to this rulemaking

that FSIS considered were, in addition

to the alternative of no rulemaking,

those of mandating additional in-plant

controls and mandating general

requirements and standards for PQC

programs.

The alternative of no rulemaking

would impose no additional regulatory

burdens on establishments, which

would continue to have the assurance

that their PQC programs meet basic

design criteria. However, the Agency

rejected this alternative. The failure to

change the regulations would leave in

place a prescriptive regulatory regime

for process controls and PQC programs

that also conflicts in a material way

with the objectives of the PR/HACCP

final rule. Under HACCP,

establishments assume responsibility for

building science-based, preventive

process controls into the food

production system to reduce or

eliminate food safety hazards. This

responsibility includes ensuring that

processes conform with sound food

safety performance standards.

Establishments need to be able to

implement better and more innovative

food safety and other consumerprotection strategies, including having

flexibility to design a PQC program and

determine its content and

implementation date.

The alternative of mandating

additional in-plant controls, whether in

addition to or in lieu of PQC

requirements, would add regulatory

assurances that processes are under

control and that products are safe,

wholesome, and not misbranded.

However, this alternative would add

prescriptive, command-and-control

requirements and restrict the scope for

establishment food safety initiatives,

contradicting the Agency’s new

regulatory approach. The additional

requirements also would likely not

result in food safety improvement.

The alternative of mandating new

general requirements or standards for

PQC programs would differ little in its

effects from the current requirements for

PQC programs to have certain features

and for process control under the

programs to be based on generally

accepted statistical principles (9 CFR

318.4(d); 381.145(d)). Even if the current

requirements were condensed, they

would still be inconsistent with the PR/

HACCP regulations and with the

Agency’s new regulatory approach,

establishments would continue to incur

a substantial recordkeeping burden, and

the Agency would have nearly the same

burden as it now does of verifying

establishment compliance with the

requirements.

FSIS chose the option of eliminating

regulatory requirements for all PQC

programs except QC programs for the

irradiation of poultry products. (As

mentioned previously, the final rule

‘‘Irradiation of Meat Food Products’’

removed requirements for poultry

irradiation QC programs.) This option

provides establishments with the most

Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations 34387

flexibility in implementing process

control programs in a HACCP

environment.

This final rule will affect, overall, as

many as 72 poultry slaughtering

establishments and about 3,550

establishments that process meat and

poultry products beyond slaughtering,

dressing, and cut-up. The most farreaching effect of the rule will be to

increase the flexibility establishments

have in controlling their processes. This

benefit arises from eliminating the

required PQC program elements in

§§ 318.4(d) and 381.145(d).

With or without this final rule,

establishment HACCP plans will

supersede or incorporate the few PQC

programs that control food safety

factors. Under the final rule, most

establishments that have PQC programs

that control for non-food safety factors

will continue to use the programs. In all

likelihood, in developing new PQC

programs, they will continue to include

the information now required by FSIS.

They will also be free to adopt other

methods of process control and different

techniques of observation,

measurement, documentation,

recordkeeping, and evaluation than are

prescribed in the current regulations.

They are likely to change their PQCcontrolled operations to coordinate their

food quality process control more

effectively with their HACCP system

operations to improve overall efficiency.

Thus, raw material control, which has

been a required element in PQC

programs, could be handled under a

HACCP plan with a CCP for raw

materials, and other process controls for

food safety could be handled in the

same manner. Similarly, the records

requirements for PQC programs could

be superseded by more efficient and

appropriate establishment-developed

systems. Establishments would thus be

able to achieve unquantifiable gains in

efficiency that would yield food safety

and other consumer-protection benefits.

FSIS-inspected establishments

develop about 1,900 PQC programs a

year according to regulatory design

specifications. Assuming that a PQC

program is developed by a QC manager

earning about $26 an hour, and that it

takes about 20 hours, on average, to

develop a PQC program, the cost to an

establishment of developing such a

program is about $520. FSIS estimates

that the cost to the regulated industry of

developing such programs is about

$1,000,000 per year.

This cost of developing PQC programs

according to FSIS requirements, plus

$13 million in annual operating costs

for about 1,852 mandatory (required by

regulation) PQC programs ($26/hr. × 260

hrs./yr./program × 1,852 programs), add

up to about $14 million in costs to the

regulated industry.

For most establishments, the final rule

will not yield immediate, direct savings

from removal of burdens associated

with developing PQC programs because

most PQC programs are voluntarily

adopted by establishments.

Establishments likely will continue the

use of QC methods in their operations,

so the removal of the regulatory

requirement for establishments to follow

the regulatory design specifications will

not immediately yield a savings to

establishments. Further, a substantial

proportion of the costs of complying

with this regulation was removed with

the publication of the final rule

eliminating prior approvals for facilities,

equipment, and PQC programs (62 FR

45016; August 25, 1997).

However, FSIS currently requires that

if establishments adopt PQC programs,

the programs must meet certain design

specifications and must contain certain

specified information. Some

establishments that are required to have

PQC programs for certain products and

processes would benefit from the

removal of burdens associated with

developing PQC programs. These

establishments, including those

involved in producing MS(S), meat cuts

treated with organic acids, and other

processing, may benefit from shifting

some portion of their PQC program

development and operation costs into

HACCP-related or other activities.

Also, under the final rule,

establishments would have greater

freedom to innovate. An indeterminate

proportion of the annual burden of

developing PQC programs according to

FSIS specifications could eventually be

channeled into more efficient and

effective use of industry resources,

especially where PQC programs have

been operated.

Thus, although there will not be a

direct savings from the removal of the

regulatory requirements governing PQC

programs, the industry potentially will

be able to make more efficient and

effective use of the $1 million or so in

annual costs of developing the

programs.

Finally, the final rule will permit FSIS

to reallocate field inspection and

headquarters resources now used in

oversight of establishment-operated

PQC programs to higher priority food

safety-related activities.

Regulatory Flexibility Act

The Administrator of FSIS has

determined that this final rule will not

have a significant effect on a substantial

number of small entities. The final rule

will affect about 72 poultry slaughtering

establishments, most of which are large

business enterprises. It also will affect

as many as 3,550 official meat and

poultry processing establishments, of

which a substantial majority, 3,330, are

considered small entities under Small

Business Administration criteria (500 or

fewer employees per establishment).

However, the rule will not have a

significant effect on these

establishments. It will impose no new

regulatory requirements necessitating

investments or other resource

commitments by establishments but

would, by removing a number of

existing regulatory requirements, permit

more efficient resource utilization,

especially to support establishment

HACCP systems.

The final rule will remove the

remaining requirements for

establishments to have PQC programs

for certain products or processes and the

general requirement concerning the

design of such programs. The final rule

will give inspected establishments

greater flexibility to innovate and to

introduce new processes or products

that meet HACCP or other consumer

protection objectives. As a result, the

final rule will theoretically provide

several thousand dollars of regulatory

relief annually per establishment.

The final rule will enable

establishments to avoid the costs

associated with developing and

implementing PQC programs that

address regulatory requirements for the

use of certain substances in preparation

of meat and poultry products, such as

the use of organic acids to delay

discoloration of fresh meat cuts.

Thermal processing establishments (of

which there are about 130) will avoid

the costs associated with developing

PQC programs according to Agency

specifications and the costs associated

with obtaining Agency prior approvals.

As many as 3,330 small

establishments will no longer be

required to operate PQC programs for

certain processes (such as PQC

programs for processing cooked beef)

and products (such as mechanically

separated, or ‘‘deboned,’’ product).

Small and large establishments will save

about $520 per PQC program in

development costs for 310 mandatory

PQC programs, or $161,720 total. Out of

this total, small establishments will save

about $151,320.

Operating costs of PQC programs vary

widely. A simple PQC program to verify

the accuracy of scales, for example, may

require that tests be performed only

several times a year, at little cost in

operator time. A PQC program for a

complex process, on the other hand,

34388 Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations

may require daily tests and data

collection and recordkeeping tasks

lasting up to 4 hours. For the purposes

of this document, PQC programs are

each assumed to require up to 1 hour’s

worth of daily attention by the

establishment QC specialist. The

removal of the PQC requirements will

relieve small establishments of these

burdens.

Assuming, for example, that small

establishments incur annual costs of

about $12,000,000 in operating

mandatory PQC programs (solely in

operating the QC evaluation process of

such programs, and not including

laboratory analysis or special facilities

that may be required to determine

whether products are in compliance

with the regulations), each

establishment will save about $3,600 in

PQC program operations.

In addition, small establishments will

benefit from savings (at the rate of $300

per establishment) that accrue from the

removal of regulatory design

requirements for both mandatory and

voluntary PQC programs. They will

have flexibility to develop and

implement HACCP-consistent or other

process control systems, beyond the

flexibility that was provided by the FSIS

final rule that removed prior approval

requirements for blueprints, equipment,

and certain PQC programs (62 FR 45016;

August 25, 1997).

Thus, at least $3,900 in recurring

savings is available to each small meat

and poultry establishment. However,

because many, if not most, affected

establishments will be likely to continue

to operate PQC programs that help in

producing products with consistent and

uniform characteristics, establishments

may not choose to reap the savings that

could result from adopting alternatives

to their PQC programs. The effect of the

final rule on the substantial number of

affected small establishments is

therefore not likely to be significant.

Executive Order 12988

This final rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. States and local

jurisdictions are preempted by the

Federal Meat Inspection Act (FMIA) and

the Poultry Products Inspection Act

(PPIA) from imposing any marking or

packaging requirements on federally

inspected meat and meat products or

poultry products that are in addition to,

or different than, those imposed under

the FMIA and 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 or

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 final 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 final

rule. However, the administrative

procedures specified in 9 CFR 381.35

must be exhausted prior to any judicial

challenge of the application of the

provisions of this final rule, if the

challenge involves any decision of an

FSIS employee relating to inspection

services provided under the FMIA or

PPIA.

Executive Order 12898

Pursuant to Executive Order 12898

(59 FR 7629; February 16, 1994),

‘‘Federal Actions to Address

Environmental Justice in Minority and

Low-Income Populations,’’ FSIS has

considered potential impacts of this

final rule on environmental and health

conditions in low-income and minority

communities.

This final rule will remove the

requirements pertaining to PQC

programs in federally inspected meat

and poultry establishments. It will also

remove from the canning regulations all

requirements concerning PQC programs,

the requirements for case-by-case FSIS

approval of systems and devices not

specified in the regulations, and several

other prior-approval requirements.

As explained in the economic impact

analysis, the regulations should

generally benefit firms that process

meat, meat food products, and poultry

products. The regulations will not

require or compel meat or poultry

establishments to relocate or alter their

operations in ways that could adversely

affect the public health or environment

in low-income and minority

communities. Further, this final rule

will not exclude any persons or

populations from participation in FSIS

programs, deny any persons or

populations the benefits of FSIS

programs, or subject any persons or

populations to discrimination because

of their race, color, or national origin.

The benefits of this final rule from

ensuring that products are not

adulterated or misbranded will accrue

to the members of all classes of the

public, including minorities, women,

and persons with disabilities.

About 4 percent of official meat and

poultry establishments are under female

or minority ownership. FSIS does not

believe that the effects of this

rulemaking, whether beneficial or

adverse, on such establishments will be

disproportionate. however, the Agency

welcomes any data or information that

would contribute to an understanding of

the effects of this rule on minorities,

women, or persons with disabilities.

Additional Public Notification

Public awareness of all stages of

rulemaking and policy development is

important. Consequently, in an effort to

better ensure that minorities, women,

and persons with disabilities are aware

of this final rule, FSIS will announce it

and provide copies of this Federal

Register publication in the weekly FSIS

Constituent Update. FSIS communicates

the Constituent Update by fax to over

300 organizations and individuals. In

addition, the update is available on line

through the FSIS web page located at

‘‘http://www.fsis.usda.gov’’. The update

is used to provide information regarding

FSIS policies, procedures, regulations,

Federal Register notices, FSIS public

meetings, recalls, and other information

that could affect or would be of interest

to the Agency’s constituents/

stakeholders. The constituent fax list

consists of industry, trade, and farm

groups, consumer interest groups, allied

health professionals, scientific

professionals, and other individuals

who have requested to be included.

Through these various channels, FSIS is

able to provide information to a much

broader, more diverse audience. For

more information and to be added to the

constituent fax list, readers of this

document may fax their requests to the

Congressional and Public Affairs Office,

at (202) 720–5704.

Paperwork Requirements

Title: Processing Procedures and

Quality Control Systems.

Type of Collection: Revision.

Abstract: FSIS has reviewed the

paperwork and recordkeeping

requirements in this final rule in

accordance with the Paperwork

Reduction Act. This final rule will

substantially reduce reporting

requirements for official establishments.

The final rule will remove the design

requirements affecting most PQC

programs that establishments have and

most requirements for establishments to

have PQC programs for certain products

or processes. Currently, there are

624,465 burden hours associated with

the PQC program requirements. FSIS

will request OMB to eliminate all these

burden hours from the information

collection request 0583–0089.

Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations 34389

List of Subjects

9 CFR Part 317

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR Part 318

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR Part 319

Food labeling, Incorporation by

reference, Meat inspection.

9 CFR Part 381

Poultry and poultry products,

Reporting and recordkeeping

requirements.

9 CFR Part 424

Food additives, Food packaging, Meat

inspection, Poultry and poultry

products.

For the reasons set forth in the

preamble, FSIS is amending 9 CFR

chapter III, the Federal meat and poultry

inspection regulations, as follows:

PART 317—LABELING, MARKING

DEVICES, AND CONTAINERS

1. The authority citation for part 317

continues to read as follows:

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

2.53.

§ 317.21 [Amended]

2. Paragraph (b) of § 317.21 is

amended by removing the comma and

all words following the word ‘‘person’’.

PART 318—ENTRY INTO OFFICIAL

ESTABLISHMENTS; REINSPECTION

AND PREPARATION OF PRODUCTS

3. The authority citation for part 318

continues 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.

§ 318.4 [Amended]

4. Paragraph (d) of § 318.4 is removed

and reserved.

5. In § 318.305, paragraph (d)(5) is

removed, and paragraphs (a)(1)(ii),

(a)(2)(ii), and (f) are revised to read as

follows:

§ 318.305 Equipment and procedures for

heat processing systems.

(a) * * *

(1) * * *

(ii) Other devices. Temperatureindicating devices, such as resistance

temperature detectors, used in lieu of

mercury-in-glass thermometers, shall

meet known, accurate standards for

such devices when tested for accuracy.

The records of such testing shall be

available to FSIS program employees.

(2) * * *

(ii) Other devices. Temperature/time

recording devices or procedures used in

lieu of chart-type devices must meet

known accurate standards for such

devices or procedures when tested for

accuracy. Such a device must be

accurate enough for ensuring that

process time and temperature

parameters have been met.

* * * * *

(f) Other systems. All other systems

not specifically delineated in this

section and used for the thermal

processing of canned product shall be

adequate to produce shelf-stable

products consistently and uniformly.

* * * * *

6. Paragraph (b) of § 318.307 is revised

to read as follows:

§ 318.307 Record review and maintenance.

* * * * *

(b) Automated process monitoring

and recordkeeping. Automated process

monitoring and recordkeeping systems

shall be designed and operated in a

manner that will ensure compliance

with the applicable requirements of

§ 318.306.

* * * * *

7. In § 318.308, paragraph (b) is

revised, paragraph (c) is removed and

reserved, and paragraph (d) introductory

text is revised to read as follows:

§ 318.308 Deviations in processing.

* * * * *

(b) Deviations in processing (or

process deviations) must be handled

according to:

(1)(i) A HACCP plan for canned

product that addresses hazards

associated with microbial

contamination, or

(ii) Paragraph (d) of this section.

(c) [Reserved]

(d) Alternative procedures for

handling process deviations.

* * * * *

8. In § 318.309, paragraph (a) is

revised, paragraphs (b) and (c) are

removed and reserved, and paragraph

(d) introductory text is revised, to read

as follows:

§ 318.309 Finished product inspection.

(a) Finished product inspections must

be handled according to:

(1) A HACCP plan for canned product

that addresses hazards associated with

microbiological contamination;

(2) An FSIS-approved total quality

control system;

(3) Alternative documented

procedures that will ensure that only

safe and stable product is shipped in

commerce; or

(4) Paragraph (d) of this section.

(b) [Reserved]

(c) [Reserved]

(d) Alternative procedures for

handling finished product inspections.

* * * * *

PART 319—DEFINITIONS AND

STANDARDS OF IDENTITY OR

COMPOSITION

9. The authority citation for part 319

continues to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 601–695; 7 CFR 2.18, 2.53.

10. Paragraph (e)(2) of § 319.5 is

revised to read as follows:

§ 319.5 Mechanically Separated (Species).

* * * * *

(e) * * *

(2) Analytical methods used by

establishments in verifying the fat,

protein, and calcium content of product

consisting of or containing

Mechanically Separated (Species) shall

be among those listed in ‘‘Official

Methods of Analysis of the Association

of Official Analytical Chemists

(AOAC),’’ 16th edition, 1995, §§ 960.39,

976.21, 928.08 (Chapter 39), and 940.33

(Chapter 45), which is incorporated by

reference, or, if no AOAC method is

available, in the ‘‘Chemistry Laboratory

Guidebook,’’ U.S. Department of

Agriculture, Washington, D.C., March

1986 edition, sections 6.011–6.013,

Revised June 1987 (pages 6–35 through

6–65), or by appropriate methods

validated by scientific bodies in

collaborative trials. The ‘‘Official

Methods of Analysis of the Association

of Official Analytical Chemists,’’

Chapter 39 and Chapter 45, subsection

45.2.06 (AOAC Official Method 940.33),

16th edition, 1995, are incorporated by

reference with the approval of the

Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1

CFR Part 51.

§ 319.104 [Amended]

11. Section 319.104 is amended in

paragraph (a) by removing the last

sentence of footnote 3 to the chart.

§ 319.105 [Amended]

12. Section 319.105 is amended in

paragraph (a) by removing the last

sentence of footnote 2 to the chart.

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

13. The authority citation for part 381

continues to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C.

451–470; 7 CFR 2.18, 2.53.

34390 Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations

14. Section 381.76 is amended

follows:

a. Paragraph (b)(1)(ii)(b) is revised.

b. Paragraph (b)(1)(iii)(b) is revised.

c. Paragraph (b)(4)(i)(a) introductory

text is revised.

d. Paragraph (b)(4)(i)(b) is revised.

e. Paragraph (b)(4)(ii) is removed and

reserved.

f. Paragraph (b)(4)(iii) is removed and

reserved.

g. Paragraph (b)(5)(i)(a) introductory

text is revised.

h. Paragraph (b)(5)(i)(b) is revised.

i. Paragraph (b)(5)(ii) is removed and

reserved.

j. Paragraph (b)(5)(iii) is removed and

reserved.

k. Paragraph (c) is removed.

The revisions read as follows:

§ 381.76 Post-mortem inspection, when

required; extent; traditional, Streamlined

Inspection System (SIS), New Line Speed

(NELS) Inspection System and the New

Turkey Inspection (NTI) System; rate of

inspection.

* * * * *

(b)(1) * * *

(ii) * * *

(b) The Administrator determines that

the establishment has the intent and

capability to operate at line speeds

greater than 70 birds per minute, and

meets all the facility requirements in

§ 381.36(d).

(iii) * * *

(b) The Administrator determines that

the establishment meets all the facility

requirements in § 381.36(e).

* * * * *

(4) * * *

(i) * * *

(a) Post-mortem inspection. The

establishment shall provide three

inspection stations on each eviscerating

line in compliance with the facility

requirements § 381.36(d)(1). The three

inspectors shall inspect the inside,

viscera, and outside of all birds

presented. Each inspector shall be

flanked by two establishment

employees—the presenter and the

helper. The presenter shall ensure that

the bird is properly eviscerated and

presented for inspection and the viscera

uniformly trailing or leading. The

inspector shall determine which birds

shall be salvaged, reprocessed,

condemned, retained for disposition by

the veterinarian, or allowed to proceed

down the line as a passed bird subject

to reinspection. Poultry carcasses with

certain defects not requiring

condemnation of the entire carcass shall

be passed by the inspector, but shall be

subject to reinspection to ensure the

physical removal of the specified

defects. The helper, under the

supervision of the inspector, shall mark

such carcasses for trim when the defects

are not readily observable. Trimming or

birds passed subject to reinspection

shall be performed by:

* * * * *

(b) A reinspection station shall be

located at the end of each line. This

station shall comply with the facility

requirements in § 381.36(d)(2). The

inspector shall ensure that the

establishment has performed the

indicated trimming of carcasses passed

subject to reinspection by visually

monitoring, checking data, or gathering

samples at the station or at other critical

points on the line.

(ii) [Reserved]

(iii) [Reserved]

(5) * * *

(i) * * *

(a) Post-mortem inspection. Each

inspection station must comply with the

facility requirements in § 381.36(e)(1).

Each inspector shall be flanked by and

establishment employee assigned to be

the inspector’s helper. The one

inspector on an NTI–1 Inspection

System shall be presented every bird.

Each inspector on an NTI–2 Inspection

System line shall be presented every

other bird on the line. An establishment

employee shall present each bird to the

inspector properly eviscerated with the

back side toward the inspector and the

viscera uniformly trailing or leading.

Each inspector shall inspect the inside,

viscera, and outside of all birds

presented. The inspector shall

determine which bird shall be salvaged,

reprocessed, condemned, retained for

disposition by a veterinarian, or allowed

to proceed down the line as a passed

bird subject to reinspection. Turkey

carcasses with certain defects not

requiring condemnation of the entire

carcass shall be passed by the inspector,

but shall be subject to reinspection to

ensure the physical removal of the

specified defects. The helper, under the

supervision of the inspector, shall mark

such carcasses for trim when the defects

of birds passed subject to reinspection

shall be performed by:

* * * * *

(b) Reinspection. A reinspection

station shall be located at the end of the

lines. This station shall comply with the

facility requirements in § 381.36(e)(2).

The inspector shall ensure that

establishments have performed the

indicated trimming of each carcass

passed subject to reinspection by

visually monitoring, checking data, and/

or sampling product at the reinspection

station and, if necessary, at other points,

critical to the wholesomeness of

product, on the eviscerating line.

(ii) [Reserved]

(iii) [Reserved]

§ 381.121d [Amended]

15. Paragraph (b) of § 381.121d is

amended by removing the comma and

all words following the word ‘‘person.’’

§ 381.145 [Amended]

16. Paragraphs (d) and (e) of § 381.145

are removed and reserved.

17. In § 381.305, paragraph (d)(5) is

removed, and paragraphs (a)(1)(ii),

(a)(2)(ii), and (f) are revised to read as

follows:

§ 381.305 Equipment and procedures for

heat processing systems.

(a) * * *

(1) * * *

(ii) Other devices. Temperatureindicating devices used in lieu of

mercury-in-glass thermometers, such as

resistance temperature detectors, shall

meet known, accurate standards for

such devices when tested for accuracy.

The records of such testing shall be

available to FSIS program employees.

(2) * * *

(ii) Other devices. Temperature/time

recording devices or procedures used in

lieu of chart-type devices must meet

known accurate standards for such

devices or procedures when tested for

accuracy. Such a device must be

accurate enough for ensuring that

process time and temperature

parameters have been met.

* * * * *

(f) Other systems. All other systems

not specifically delineated in this

section and used for the thermal

processing of canned product shall be

adequate to produce shelf-stable

products consistently and uniformly.

* * * * *

18. Paragraph (b) of § 381.307 is

revised to read as follows:

§ 381.307 Record review and maintenance.

* * * * *

(b) Automated process monitoring

and recordkeeping. Automated process

monitoring and recordkeeping systems

shall be designed and operated in a

manner which will ensure compliance

with the applicable requirements of

§ 381.306.

* * * * *

19. In § 381.308, paragraph (b) is

revised, paragraph (c) is removed and

reserved, and paragraph (d) introductory

text is revised to read as follows:

§ 381.308 Deviations in processing.

* * * * *

(b) Deviations in processing (or

process deviations) must be handled

according to:

Federal Register / Vol. 65, No. 104 / Tuesday, May 30, 2000 / Rules and Regulations 34391

(1) A HACCP plan for canned product

that addresses hazards associated with

microbial contamination; or

(2) Paragraph (d) of this section.

(c) [Reserved]

(d) Alternative procedures for

handling process deviations.

* * * * *

20. In § 381.309, paragraph (a) is

revised, paragraphs (b) and (c) are

removed and reserved, and paragraph

(d) introductory text is revised, to read

as follows:

§ 381.309 Finished product inspection.

(a) Finished product inspections must

be handled according to:

(1) A HACCP plan for canned product

that addresses hazards associated with

microbiological contamination; or

(2) An FSIS-approved total quality

control system; or

(3) Alternative documented

procedures that will ensure that only

product that is safe and stable is

shipped in commerce; or

(4) Paragraph (d) of this section.

(b) [Reserved]

(c) [Reserved]

(d) Alternative procedures for

handling finished product inspections.

* * * * *

PART 424—PREPARATION AND

PROCESSING OPERATIONS

21. The authority citation for part 424

continues to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53.

22. In the table in § 424.21(c), under

the Class of substance ‘‘Miscellaneous,’’

the entry for the Substance ‘‘Ascorbic

acid, erythorbic acid, citric acid, sodium

ascorbate, and sodium citrate, singly or

in combination’’ is revised to read as

follows:

§ 424.21 Use of food ingredients and

sources of radiation.

* * * * *

(c) * * *

Class of substance Substance Purpose Products Amount

*******

Miscellaneous ........ Ascorbic acid,

erythorbic acid,

citric acid, sodium

ascorbate and sodium citrate, singly or in combination.

To delay discoloration.Fresh beef cuts,

fresh lamb cuts,

and fresh pork

cuts.

Not to exceed, singly or in combination, 500 ppm or 1.8 mg/

sq inch of product surface of ascorbic acid (in accordance

with 21 CFR 182.3013), erythorbic acid (in accordance

with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly

or in combination, 250 ppm or 0.9 mg/sq inch of product

surface of citric acid (in accordance with 21 CFR

182.6033), or sodium citrate (in accordance with 21 CFR

182.6751).

*******

* * * * *

23. In § 424.22, paragraphs

(b)(1)(ii)(A) and (B) are revised to read

as follows:

§ 424.22 Certain other permitted uses.

* * * * *

(b) * * *

(1) * * *

(ii) * * *

(A) 100 ppm ingoing (potassium

nitrite at 123 ppm ingoing); and 550

ppm sodium ascorbate or sodium

erythorbate (isoascorbate) shall be used;

or

(B) A predetermined level between 40

and 80 ppm (potassium nitrite at a level

between 49 and 99 ppm); 550 ppm

sodium ascorbate or sodium erythorbate

(isoascorbate); and additional sucrose or

other similar fermentable carbohydrate

at a minimum of 0.7 percent and an

inoculum of lactic acid producing

bacteria such as Pediococcus acetolactii

or other bacteria demonstrated to be

equally effective in preventing the

production of botulinum toxin at a level

sufficient for the purpose of preventing

the production of botulinum toxin.

* * * * *

Done at Washington, DC, on May 12, 2000.

Thomas J. Billy,

Administrator.

[FR Doc. 00–12659 Filed 5–26–00; 8:45 am]

BILLING CODE 3410–DM–P

FEDERAL RESERVE SYSTEM

12 CFR Part 261a

[Docket No. R–1071]

Rules Regarding Access to Personal

Information Under the Privacy Act

AGENCY: Board of Governors of the

Federal Reserve System.

ACTION: Final rule.

SUMMARY: In accordance with the

Privacy Act, the Board of Governors of

the Federal Reserve System (Board) is

amending its Rules Regarding Access to

Personal Information under the Privacy

Act to include a new system of records,

entitled Multi-rater Feedback Records

(BGFRS–25) to the list of system of

records that is exempt from certain

required disclosures. Notice of the new

system of records is published

elsewhere in this Federal Register.

EFFECTIVE DATE: June 28, 2000.

FOR FURTHER INFORMATION CONTACT:

Elaine M. Boutilier, Senior Counsel,

Legal Division (202/452–2418), or Chris

Fields, Manager, Human Resources

Function, Management Division (202/

452–3654), Board of Governors of the

Federal Reserve System, 20th Street and

Constitution Avenue, NW, Washington,

DC 20551. For users of the

Telecommunications Device for the Deaf

(TDD) only, contact Janice Simms at

202/452–4984.

SUPPLEMENTARY INFORMATION:

The Board is instituting a feedback

program for its managers and officers.

Under this Multi-rater Feedback

program, Board employees who work

for or with a particular manager or

officer are asked to complete a

voluntary, confidential questionnaire

regarding the performance of that

manager/officer and send it directly to

a consultant hired by the Board for this

program. The consultant analyzes the

completed questionnaires and compiles

a report for the manager/officer that

summarizes the comments from the

questionnaires. This report does not

identify individual comments or those

who completed the questionnaires. The

report is given only to the manager/

officer being evaluated; no other Board