Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67469

requesting approval of the use of substances

in meat or poultry products.

5. When petitioned, conduct rulemaking

that would permit under the FFDCA use of

a substance in meat or poultry, including

those restrictions or conditions of use in meat

or poultry products that are recommended in

writing by FSIS, and for which there are data

or other information establishing that the use

of the substance is safe and not deceptive.

FDA will also consult with FSIS on any

comments received on petitions regarding

meat or poultry uses.

C. FSIS and FDA jointly agree:

1. That the officials of the two Agencies

responsible for implementing the Agreement

are:

At FSIS: the Administrator and Deputy

Administrators (as may be designated);

Director, Product Assessment Division;

Branch Chief, Food Standards and

Ingredients Branch.

At FDA: Director, Center for Food Safety

and Applied Nutrition; Director, Office of

Pre-Market Approval.

2. That the responsible officials will concur

on rulemaking documents that, when

published by FDA, will list or amend listings

of substances permitted for use in meat and

poultry products.

3. That the Administrator of FSIS and the

Director, CFSAN, FDA, shall resolve

problems and make decisions by consensus

in areas of disagreement.

VI. Conflict Resolution

Each Agency reserves the authority to

review, independently of the other, matters

of concern to their respective authorities.

However, written notice will be provided to

the Commissioner of Food and Drugs and to

the Under Secretary for Food Safety, USDA,

of any rulemaking initiative not in keeping

with the provisions of this MOU or about

which there is an interagency disagreement,

prior to public announcement of the

rulemaking.

VII. Other Agreements

A. The provisions of this MOU are not

intended to add to or detract from any of the

authorities provided to either FDA or FSIS by

the FFDCA, FMIA, or the PPIA, or the

regulations by which these laws are

implemented.

B. FSIS and FDA may enter into additional,

separate agreements with each other as they

deem appropriate to achieve the objectives of

this MOU.

VIII. Duration of MOU

This Agreement becomes effective upon

acceptance by both Agencies and will

continue indefinitely. It may be modified by

mutual written consent or terminated by

either agency with a 30-day written notice to

the other agency.

Signed:

lllllllllllllllllllll

Director, CFSAN, FDA

lllllllllllllllllllll

Date

lllllllllllllllllllll

Administrator, FSIS

Guidelines for Acceptability Determinations

for New Substances and New Uses of

Substances in Meat and Poultry Products

The evaluation by FSIS of the acceptable

use of a new substance or new use of a

substance in meat and poultry products

subject to this MOU will be based on the

following conditions that must be addressed

by the requester. The conditions set forth are

in accordance with the provisions for use of

substances in 9 CFR and 21 CFR.

1. The substance has a documented history

of use in foods.

2. The substance is derived from food or

a food ingredient and is not considered to be

a chemical or synthesized additive.

3. The process for manufacturing the

substance does not result in a severe

alteration of the molecular structure resulting

in the formation of a chemical residue whose

safety has not been shown.

4. The safety of the substance has been

evaluated by an independent authority and

adequate safety data have been presented.

5. The suitability and efficacy of the

substance have been shown through adequate

data submission. The lowest level of the

substance necessary to achieve the intended

functional effect must be shown and the use

cannot render the products to which the

substance is intended for use adulterated or

misbranded.

6. The FDA has determined the common or

usual name of the substance(s).

7. FDA must concur with FSIS’s

determination of acceptability in order to

allow use.

[FR Doc. 95–31390 Filed 12–26–95; 3:36 pm]

BILLING CODE 3410–DM–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 304, 305, 306, 307,

318, 325, and 381

[Docket No. 95–008A]

RIN 0583–AB89

FSIS Agenda for Change: Regulatory

Review

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Advance Notice of Proposed

Rulemaking; Request for Comments.

SUMMARY: The Food Safety and

Inspection Service (FSIS) has begun a

comprehensive review of its regulatory

procedures and requirements to

determine which are still needed and

which ought to be modified,

streamlined, or eliminated. This review

is an integral part of the FSIS initiative

to improve the safety of meat and

poultry products by modernizing the

Agency’s system of food safety

regulation. It also moves beyond the

page-by-page review of FSIS regulations

carried out earlier this year under the

President’s Reinvention of Government

Initiative. A thorough review of FSIS’s

regulations is needed to prepare for

implementation of the Agency’s

proposed Hazard Analysis and Critical

Control Points (HACCP) regulations and

a new food safety strategy that will

reduce reliance on command-andcontrol regulations and increase reliance

on science-based preventive measures

and performance standards to improve

food safety. This review and any

changes in FSIS regulations that are

necessary to make them compatible

with HACCP will be completed prior to

implementation of HACCP. FSIS invites

comment from the public and all

interested parties on the Agency’s

preliminary review of its regulations

and specific suggestions on which

regulations need to be eliminated or

changed to be compatible with HACCP,

and how they should be changed, or to

achieve Reinvention of Government

goals of having fewer, clearer, and more

user-friendly regulations.

Some of the rulemakings needed to

streamline existing requirements and

carry out the FSIS food safety strategy

are being initiated or effectuated in

documents that appear elsewhere in this

issue of the Federal Register: A

proposed rule that would eliminate the

FSIS prior approval system for

substances added to meat and poultry

products; a proposed rule that would

facilitate marketing of nutritionally

improved alternatives to standardized

meat and poultry food products; and a

final rule streamlining the prior

approval system for meat and poultry

labels.

As FSIS progresses in its

comprehensive regulatory review, FSIS

will publish further proposals to

eliminate unnecessary regulations and

modify remaining regulations,

replacing, to the extent possible,

command-and-control regulations with

performance standards, clarifying the

role of inspectors in enforcing those

standards, and reorganizing and

simplifying the regulations to make

them easier to understand and use.

DATES: Comments must be received on

or before February 27, 1996.

ADDRESSES: Please send an original and

two copies of written comments to

Policy, Evaluation, and Planning Staff,

Attn: FSIS Docket Clerk, DOCKET No.

95–008A, Room 4352 South Building,

Food Safety and Inspection Service,

U.S. Department of Agriculture,

Washington, DC 20250. Oral comments,

as permitted under the Poultry Products

Inspection Act, should be directed to

the person listed under FOR FURTHER

INFORMATION CONTACT.
67470 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

FOR FURTHER INFORMATION CONTACT: Dr.

Paula M. Cohen, Director, Regulations

Development, at (202) 720–7164.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. FSIS Regulatory Reform Strategy

II. Comprehensive Review and

Reorganization of FSIS Regulations

III. Initial Review of Regulations; Consistency

with HACCP

IV. Request for Comments

I. FSIS Regulatory Reform Strategy

The Food Safety and Inspection

Service is responsible for carrying out

the mandates of the Federal Meat

Inspection Act (21 U.S.C. 601 et seq.),

the Poultry Products Inspection Act (21

U.S.C. 451 et seq.), and most recently,

the Egg Products Inspection Act (21

U.S.C. 1031 et seq.), by ensuring that

meat, meat food, poultry, and egg

products are safe, wholesome, not

adulterated, and properly marked,

labeled, and packaged. FSIS and its

predecessor agencies have protected

consumers for nearly a century

primarily through in-plant inspection

procedures to assure that raw animal

tissues are free of disease and visible

contamination, that further processed

products are processed under

appropriate controls and meet

applicable composition requirements,

and that all products are produced

under sanitary conditions and are

packaged and labeled in a manner that

is not misleading.

The Agency’s inspection programs

have contributed significantly to the

safety and quality of meat and poultry

products consumed in this country.

Increasingly, however, the need to

reassess these programs and to reshape

them to meet the challenges of the

future has become apparent. Today,

FSIS is confronting three imperatives:

(1) The need to improve food safety to

meet persistent as well as changing

threats to public health; (2) the need to

make better use of scarce resources in

meeting those public health challenges;

and (3) the need to reexamine its

regulations, culling out or reforming

those that are obsolete, impose

unnecessary burdens or are inconsistent

with Agency food safety initiatives, and

restructure the essential regulations that

remain to make them easier to

understand and use.

Need To Improve Food Safety

The need to take steps to improve

food safety has been underscored by

events of recent years. The early-1993

outbreak of illness in the Western

United States, linked to hamburger

patties contaminated with the bacterium

E. coli O157:H7, showed that there are

gaps in the inspection system—most

significantly the lack of measures to

target, control, and reduce

contamination of raw meat and poultry

products with pathogenic

microorganisms. Since 1993, the Agency

has adopted regulatory control,

research, and education measures to

help fill these gaps in the system and

address the public health problem of

foodborne illness associated with such

contamination. Among these measures

are regulations mandating safe handling

labels on all raw, not ready-to-eat, meat

and poultry products (9 CFR 317.2(l);

381.125(b)(1)(i)). The Agency has

strongly encouraged the regulated

industry to find ways of reducing and

controlling the levels of microbial

pathogens on meat and poultry

products. The Agency also has begun a

program to test raw ground beef for E.

coli O157:H7 and to take regulatory

action on product found to be

adulterated with this dangerous

organism.

Pathogen Reduction/HACCP Proposal

On February 3, 1995, FSIS published

a rulemaking proposal, ‘‘Pathogen

Reduction; Hazard Analysis Critical

Control Point (HACCP) Systems’’ (60 FR

6774), which begins a fundamental

transformation of the Agency’s program

designed to reduce significantly the

incidence of foodborne illness

associated with meat and poultry

products. The notice enunciated the

FSIS food safety goal: To reduce the risk

of foodborne illness associated with the

consumption of meat and poultry

products to the extent possible by

ensuring that appropriate and feasible

measures are taken at each step in the

food production process where hazards

can enter and where procedures and

technologies exist or can be developed

to prevent the hazard or reduce the

likelihood it will occur.

HACCP is conceptually a simple

system by which food processors

identify and evaluate hazards to the

production of safe products, institute

controls necessary to reduce or

eliminate these hazards, monitor the

performance of these controls, and

maintain records of this monitoring, as

a matter of routine. HACCP embodies

the principle that the management of

every plant is responsible for building

into its food production process

systematic measures to ensure the safety

of the food the plant produces.

For HACCP to be successful, it must

be accompanied by appropriate food

safety performance standards, which

can provide a means to determine

whether a plant’s HACCP plan is

adequate and working effectively to

achieve an acceptable level of food

safety performance. Such standards

have long existed for chemical food

additives and pesticide residues, in the

form of tolerances or legal limits on the

level of additive or residue that may be

safely present in food. FSIS has also

maintained performance standards for

pathogenic microorganisms on cooked

or ready-to-eat meat and poultry

products, typically in the form of zero

tolerances (or prohibitions) on the

presence of such harmful bacteria as

Salmonella and Listeria monocytogenes.

In conjunction with HACCP and the

Agency’s new food safety strategy, FSIS

is now moving for the first time toward

performance standards for pathogenic

microorganisms on raw products.

With this approach, slaughter plants

will have an additional incentive to

improve their processes to reduce the

risk of harmful contamination and

greater flexibility to adopt innovative

new pathogen reduction procedures and

technologies in a more efficient and

effective manner than under the current

system.

Where appropriate and useful, and to

mitigate any negative impact of

proposed rules, FSIS intends to propose

performance standards which, while

affording plants the freedom to

innovate, could be met by following the

procedures in the current regulations.

Performance standards are consistent

with the HACCP philosophy, which

more clearly delineates the roles and

responsibilities of industry and

Government than does the current

regulatory approach. With

establishments free to develop plantspecific means of achieving FSISdefined food safety objectives, the

Agency will be able to better focus

inspection resources on essential

HACCP-related functions and other

tasks more focused on process than

product.

II. Comprehensive Review and

Reorganization of FSIS Regulations

To be better prepared to pursue its

food safety goals, FSIS has thoroughly

reexamined its regulatory oversight

roles, resource allocation, and

organizational structure. This top-tobottom review of the Agency was

conducted in parallel with and in

support of the Pathogen Reduction/

HACCP rulemaking. FSIS made the

preliminary reports on this review

available to the public and, in a Federal

Register notice (60 FR 47346; September

12, 1995), invited comment on the

analysis and options that had been

developed. How to redeploy

inspectional resources to more
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67471

productively focus on food safety

objectives was a key component of the

top-to-bottom review, and continues to

engage the Agency.

The inspection regulations have

accumulated over many years. The meat

inspection regulations (9 CFR

subchapter A), the poultry inspection

regulations (9 CFR subchapter C), and

the egg product inspection regulations,

under FSIS jurisdiction since June 1995

(7 CFR part 59), were developed

independently of one another; all began

separately as programs administered by

different agencies. These distinct sets of

regulations have retained their separate

identities in the Code of Federal

Regulations, despite the fact that they

are now administered by the same

agency and a large proportion of the

regulations are virtually identical.

Because of this structure, when a change

is made to one of these inspection

programs, the same or a similar change

must usually be made to the others.

Many of the provisions in the meat

and poultry (and now egg products)

regulations should be, but are not,

identical. The differences in the

provisions addressing similar topics are

largely historical artifacts which should

be eliminated. These differences

frequently cause confusion, making the

administration of inspection more

difficult and resource-intensive than it

ought to be. For example, a time limit

for appealing inspection decisions exists

under the poultry regulations but not

under the meat regulations (9 CFR

306.5; 381.35). Similarly, there is a

180°F temperature requirement for

water used to clean and disinfect meat

slaughterhouses (9 CFR 308.3(d)(4),

308.8) but not poultry establishments (9

CFR 381.50(b), 381.58(a)).

Although there are necessary

differences in how products of the

different industries are regulated, there

are many differences for which there is

no clear necessity. In some cases, it is

argued, these differences are not only

unjustified, but they are unfair in

favoring one industry at the expense of

the other.

In 1992, FSIS contracted with the

Research Triangle Institute (RTI) to

conduct a review and comparison of the

Agency’s meat and poultry regulations.

The report, delivered to the Agency in

June 1993, found 12 areas with

substantive differences in the

regulations that might be ‘‘potentially

significant in terms of relative costs of

administering the two regulatory

programs.’’

A review of that report suggests at

least three areas of regulation where this

may currently be the case: slaughter

inspection controls (only poultry has

detailed finished product standards,

which permit faster line speeds and

other plant efficiencies), removal of

contamination (poultry can be

reprocessed by washing, but meat must

be trimmed), and exemptions from

inspection (there are more categories of

exempted poultry establishments than

there are exempted meat establishments,

and the poultry regulations are more

definitive in describing products not

subject to inspection). Significant

differences in a fourth area,

‘‘mechanically separated product,’’ were

resolved in a final rule published in the

Federal Register on November 3, 1995

(60 FR 55962).

FSIS will carefully scrutinize all meat,

poultry, and egg inspection regulations

with a view to merging and

restructuring the regulations and to

unifying most of the provisions that are

common to them. As each regulatory

area is reviewed, FSIS will carefully

consider the validity of any differences

in how the industries are regulated and

will keep separate only those provisions

that must remain separate. The merging

and restructuring would simplify the

regulations; enhance administrative

efficiency; and remove unnecessary,

often confusing, and sometimes

burdensome, differences in the

regulatory treatment of FSIS-inspected

establishments and their products.

During the next few years, the Agency

will review and restructure all of its

regulations to make them easier to use.

This reflects the Agency’s position that

its regulations could be more clearly

understood if better organized and

written in ‘‘plain English.’’

In conjunction with the

comprehensive regulatory review now

in progress, FSIS is undertaking a

review of its manuals, bulletins,

directives, notices, and instructions to

its employees on how to implement

specific regulations. FSIS will address

longstanding concerns that, as the

inspection program has evolved,

procedural changes have been

introduced without systematic

consideration of whether the new

procedures overlap or are inconsistent

with other procedures. The result has

been the creation of redundant or

conflicting procedures on top of one

another, causing confusion and the

potential for nonuniform application of

inspection requirements from place to

place. Further, FSIS questions whether

the many kinds of issuances continue to

be useful, and requests comment on

how the Agency can best communicate

instructions for implementing

regulations.

III. Initial Review of Regulations;

Consistency With HACCP

As discussed in conjunction with the

FSIS regulatory proposal of February 3,

1995 (60 FR 6774), FSIS does not intend

simply to add the new HACCP system

to the current system of inspection and

regulation. FSIS intends to integrate

HACCP into a modernized system of

inspection and regulation that will

harness the power of prevention and

performance standards to improve food

safety and make better use of the

Agency’s resources. To accomplish this,

FSIS must review all of its existing

regulatory requirements and procedures

and modify, streamline, or eliminate

them, as appropriate, to be compatible

with the new food safety strategy. FSIS

has already targeted a number of its

regulations for elimination or reform

and is seeking in this document public

input as a first step in the rulemaking

required to achieve the needed changes.

Earlier this year, partly to identify

rule changes needed for HACCP-based

inspection and partly to meet

requirements of the President’s

Reinventing Government Initiative, FSIS

conducted an initial page-by-page

review of existing regulations. The

Agency identified for possible revision

or elimination more than 400 pages of

regulations. Almost three-quarters of the

regulations administered by FSIS were

projected to be eliminated or changed to

make them simpler, less burdensome, or

more performance-based.

As part of its overall food safety

initiative, the Agency is committed to

moving beyond that initial review to

making specific proposals for the near

term and to comprehensive regulatory

reform to be completed during the next

few years.

Reporting and Recordkeeping

Further, in line with the

Administration’s policy to reduce

reporting requirements in Government

programs, FSIS invites comment on its

paperwork or recordkeeping

requirements. The Agency seeks specific

recommendations for eliminating,

simplifying, or otherwise changing

information collection requirements.

FSIS also seeks recommendations for

improving or eliminating currently

required forms (FSIS Form 7234–1, the

form accompanying label submissions,

for example, or FSIS Form 8820–2, the

form meat and poultry establishment

personnel complete if inspectors find

deficiencies in processing operations).

Questions of particular concern

include the following:

• Despite efforts to prevent this, has

FSIS issued duplicative or redundant
67472 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

requirements? Do FSIS’ information and

recordkeeping requirements overlap

with those of other Federal, State, or

local agencies?

• Should individual FSIS forms be

modified or combined? If so, how?

• Should FSIS allow respondents to

use facsimiles, computers, or other

automated collection systems or

information transfer technologies? If so,

for which information requirements?

• Would it be helpful for FSIS to

accompany information requirements

with format suggestions?

• Generally, how might FSIS make

information collection activities less

burdensome?

Current Activity

FSIS has decided to publish the

following documents at this time:

• Rulemaking to make FSIS food

safety regulations compatible with

HACCP and to eliminate redundant or

unnecessary rules, initiated in this

Advance Notice of Proposed

Rulemaking (ANPR);

• Rulemaking to eliminate the FSIS

prior-approval system for substances

added to meat and poultry products, a

process initiated in a proposed rule,

‘‘Substances Approved for Use in the

Preparation of Meat and Poultry

Products,’’ docket #88–026P, published

elsewhere in this issue of the Federal

Register;

• Rulemaking to amend existing

standards of identity to give

manufacturers greater flexibility in

marketing nutritionally improved (e.g.,

reduced-fat) meat and poultry products,

‘‘Food Standards: Processed Meat and

Poultry Products Named by Use of an

Expressed Nutrient Content Claim and

Standardized Name’’ (docket #92–024P),

published elsewhere in this issue of the

Federal Register); and

• A final rule streamlining the priorapproval system for meat and poultry

labels, ‘‘Prior Labeling Approval

System,’’ docket #92–012F, published

elsewhere in this issue of the Federal

Register.

Further, FSIS is actively developing

the following: a proposal to convert

remaining rules as much as possible

from command-and-control

prescriptions to performance standards

(‘‘Performance Standards for the

Production of Certain Cooked Meat and

Poultry Products’’); a proposal to

eliminate prior-approval programs for

facility blueprints, processing

equipment, and most quality control

plans (‘‘Elimination of Prior Approval

Requirements for Establishment

Drawings and Specifications,

Equipment, and Certain Partial Quality

Control Programs’’); and an advance

notice of proposed rulemaking soliciting

comments and information on whether

to modify or eliminate specific

standards and whether, and if so how,

to modify the Agency’s overall approach

to product standards (‘‘Meat and Poultry

Standards of Identity and

Composition’’).

Planned Actions

• Review of all prior-approval

regulations not addressed in the abovementioned documents, with related

rulemaking proposals projected for

publication during 1996;

• Restructuring of FSIS meat

inspection regulations and poultry

inspection regulations, which are

currently in different subchapters of the

Code of Federal Regulations, to

eliminate duplicative and redundant

requirements and make the regulations

easier to use (initiated in this ANPR).

FSIS invites public comment on all

aspects of this regulatory reform

initiative based on the discussion

contained in the ANPR and in the

companion rulemaking proposals.

Command-and-Control Regulations and

Consistency With HACCP

The Pathogen Reduction/HACCP

proposal referred to above reflects a

basic shift in FSIS’s approach to

overseeing the safety of meat and

poultry products. FSIS intends to rely

less on command-and-control

requirements, which specify, often in

great detail, how a plant is to achieve a

particular food safety objective, and

more on performance standards, which

state an objective or level of

performance plants are expected to

achieve, and allow for greater flexibility

on the part of the plant in determining

how to achieve them. This shift to

performance standards and greater

flexibility for meat and poultry plants is

the basis of FSIS’s intention to further

stimulate the innovative capacity of the

meat and poultry industry to improve

the safety of its products.

This shift is also compelled by the

philosophy underlying HACCP. HACCP

enables plant management to build

science-based controls to prevent food

safety hazards into its food production

processes, and recognizes that the

specific controls and related measures—

the HACCP plans—required to ensure

food safety can vary from plant to plant.

Where appropriate, command-andcontrol regulations must be changed to

provide greater flexibility for industry to

design and implement processes and

HACCP systems of control, tailored to

the circumstances of each plant. This is

consistent with the HACCP approach,

which clearly delineates industry and

Government responsibility for food

safety, with plants establishing

procedures they will follow to ensure

the production of safe food. FSIS must

carefully reconsider all of its regulations

that mandate specific actions,

techniques, or processing parameters

designed to achieve a food safety

objective and determine whether they

should be eliminated or modified to

provide the flexibility required to be

consistent with HACCP. However, any

changes will not compromise food

safety standards or objectives required

to protect public health.

FSIS must also modify its regulations

in varying respects to reflect the

anticipated changes in the roles FSIS

inspectors will play in plants operating

under HACCP.

Table 1 lists the regulations FSIS has

identified as candidates for modification

or elimination to be consistent with

HACCP. Comments submitted during

that public comment period also

identified candidates for modification or

elimination. The comments are being

evaluated by FSIS and will be taken into

account as the Agency proceeds with

the necessary rulemaking. Any changes

in these or other FSIS regulations that

are required to be consistent with

HACCP will be completed before plants

are required to comply with new

HACCP requirements.

Notably, the following categories of

regulations in title 9 of the CFR are

being reviewed for consistency with

HACCP:

• Definitions (§§ 301.2 and 381.1);

• Inauguration, suspension, and

withdrawal of inspection (§§ 305.4,

305.5, and 381.19–381.21, and 381.29);

• Appeals procedures and related

administrative procedures (§§ 306.5,

335.40, and 381.35);

• Reinspection of product entering

establishments, and retention and

disposition of product (§§ 318.2 and

381.145);

• Restrictive, command-and-controltype regulations which delimit

processing and treatment methods

intended to eliminate specific food

safety hazards such as trichinae in pork;

mechanically separated product, and

various poultry products; and the

potential hazards of improper thermal

processing of meat and poultry products

and irradiation of poultry (§§ 318.6,

318.10, 318.12–318.20, 318.22–318.24,

and 318.300–318.311; and 381.148–

381.152 and 318.300–381.311); and

• Recordkeeping and access to

records under the Freedom of

Information Act (§§ 320.5–320.7,

381.179–381.181; 390.1–390.8).

FSIS is also reviewing all of its

regulations, policies, and inspection
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67473

procedures concerning plant sanitation

(§§ 308.3–308.16 and §§ 381.45–381.61).

Although implementation of the

requirement proposed on February 3,

1995, for sanitation standard operating

procedures (SOP’s) would not depend

on revisions to the Agency’s sanitation

regulations, the Agency recognizes the

need to more clearly state the

performance standards in this area.

Basic sanitation and plant hygiene

practices are, from a food-safety

perspective, among the most important

requirements in the regulations. The

Agency believes that the regulations can

be made much clearer in describing the

establishments’ roles and their

responsibility for much of the routine

work in this area, so that Federal

inspection resources can be allocated to

new, HACCP-related functions.

FSIS also invites comment on the

relationship between HACCP and the

existing regulations governing

postmortem inspection in slaughter

plants (9 CFR parts 310 and 381.76 et

seq.). HACCP is intended to address all

significant avenues of hazard affecting

the safety of meat and poultry products.

The FSIS postmortem inspection

program, which carries out the statutory

mandate for carcass-by-carcass

examination by Federal inspectors, is

designed to achieve an array of

consumer protection values, including

exclusion of diseased animals from the

food supply and enforcement of

standards regarding visible carcass

defects and contamination with visible

filth, fecal matter, or other extraneous

materials, some of which affect the

safety of the product and some of which

do not. HACCP plans for slaughter

plants will include one or more critical

control points in the slaughter and

carcass dressing process, which will

require inspectional oversight by FSIS

and, possibly, some modification of the

current postmortem inspection

regulations. FSIS invites comment on

what the relationship should be

between HACCP and the current

postmortem inspection regulations and

activity, including specific suggestions

for the manner in which current

regulations should be modified to be

consistent with HACCP.

TABLE 1.—REGULATIONS THAT ARE CANDIDATES FOR REVISION OR REMOVAL PRIOR TO HACCP IMPLEMENTATION

Regulations—FMIA, PPIA Subject Possible action

9 CFR Part

301, 381, Subpart A ......... Definitions ......................................................... Include general HACCP-related terms and redefine inspection

organization and activity terms.

304, 381, Subpart D ......... Application for and grant or refusal of inspection.Revise prior approval procedures (e.g., eliminating provisions

of § 381.19); shift to performance standards.

305 and 306, 381, Subparts E and F.Inauguration and withdrawal of inspection; inspection program employees.Clarify role of inspection program. (See, e.g., § 305.4). Integrate §§ 305.5 and 381.29 with rules for suspending and

withdrawing inspection. (See Part 335 and Part 381, Subpart W.)

Assure that appeal procedures in §§ 306.5 and 381.35 comport with enforcement under HACCP.

307, 381, Subpart G ......... Facilities for inspection ..................................... Clarify standards for essential facilities. (See, e.g., §§ 307.1,

307.2, and 381.36.)

Convert requirements for sanitation and facilities to performance standards or decision criteria; supplement with guidelines as needed. (See, e.g., §§ 308.3, 308.4, and 381.46–

381.52.)

Simplify detailed requirements for equipment and cleanliness,

for example; convert to performance standards and/or decision criteria; supplement with guidelines as needed. (See

§§ 308.6–308.9, 308.12, 308.13, and 308.16.)

Convert equipment and cleaning requirements to performance

standards and/or decision criteria; supplement with guidelines as needed. (See §§ 381.54–381.61.)

Remove obsolete provisions for slack barrels, similar containers and means of conveyance, and burlap wrapping. (See

§§ 308.10 and 308.11.)

Clarify decision criteria concerning employment of diseased

persons. (See § 308.14.)

Convert tagging insanitary equipment, utensils, rooms, and

compartments provisions to performance standards; clarify

role of inspection program employees. (See §§ 308.15 and

381.99.)

Update rules for temperatures and chilling and freezing procedures for poultry and make changes to accommodate

HACCP (i.e., changes in addition to pathogen reduction

amendments proposed 2/3/95). (See § 381.66 paragraphs

(c)(5) and (c)(6).)

318, 381, Subparts O and

X.

Entry into official establishments; reinspection;

reinspections, preparing and processing establishments.

Convert rules for articles entering establishments, and product

disposal to performance standards and clarify role of inspection program employees. (See §§ 318.3 and

381.45(a),(b), and (i).)

Eliminate prior approval procedures for total quality control

systems. (See §§ 318.4(c)–(h) and 381.145(c)–(g).)

Convert requirements for processing procedures and articles

used in preparing products to performance standards and

clarify role of inspection program employees. (See §§ 318.5,

318.6, 318.8, and 381.148.)
67474 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

TABLE 1.—REGULATIONS THAT ARE CANDIDATES FOR REVISION OR REMOVAL PRIOR TO HACCP IMPLEMENTATION—

Continued

Regulations—FMIA, PPIA Subject Possible action

Eliminate command-and-control type requirements for the use

of nitrite and sodium ascorbate or erythorbate in bacon;

convert these requirements to performance standards and

clarify role of inspection program employees. (See

§ 318.7(b).)

Convert requirements for the treatment of pork and pork products to destroy trichinae in to performance standards; supplement with guidelines as needed. (See § 318.10.)

Convert requirements for preparing articles not for use as

human food (e.g., dog food) to performance standards; clarify role of inspection program employees; eliminate command-and-control type requirements. (See §§ 318.12 and

381.152.)

Eliminate redundancy with other provisions (mixtures containing product that are not classed as meat food products).

(See § 318.13.)

Convert procedure for handling product adulterated by polluted water to performance standards and decision criteria;

supplement with guidelines as needed. (See §§ 318.14 and

381.151.)

Convert requirements for tagging chemicals, preservatives,

cereals, spices, etc., to performance standards; clarify role

of inspection program employees. (See § 318.15.)

Convert rules for substances such as pesticide chemical residues, food additives, and color additives to performance

standards and role of inspection program employees. (See

§ 318.16.)

Make requirements for handling of certain material for mechanical deboning consistent with any new time-temperature requirements. (See § 318.18.)

Convert compliance procedures for meat derived from advanced meat/bone separation machinery and recovery systems to performance standards and clarify role of inspection

program employees. (See § 318.24.)

Convert requirements for canning and canned products to

performance standards and clarify role of inspection program employees. (See §§ 318.300–318.311 and 381.300–

381.311.)

325, 381, Subpart S ......... Transportation ................................................... Eliminate obsolete provisions; focus on and clarify policies

and performance standards.

IV. Request for Comments

This ANPR is intended to elicit

comments, suggestions, and information

that will enable FSIS to provide more

efficient and effective service and to

focus its organizational resources more

closely on health and safety matters,

which are of vital concern to all

Americans. FSIS specifically requests

comment on its efforts to transform its

regulations from heavy reliance on

command-and-control approaches to

greater reliance on performance

standards, and solicits detailed

suggestions concerning which existing

regulations need to be changed to be

consistent with HACCP, and how those

regulations should be changed. The

Agency notes that several individuals

and groups, including at least one trade

association, responded to a similar

request in the February 3, 1995,

proposal. FSIS would also appreciate

comments on the economic burdens and

the paperwork, recordkeeping, or other

information collection burdens

associated with the regulations

discussed in this document.

Comments supported by scientific or

other data on the impacts, such as the

public health effects, of changing or

eliminating existing regulations, would

be especially valuable.

Executive Order 12866

This advance notice of proposed

rulemaking has been reviewed under

Executive Order 12866. This 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. FSIS does not have data necessary to

assess how the regulatory changes

discussed in this document might affect

various sectors of the meat and poultry

industries. Therefore, the Agency

invites comment on potential effects,

including economic costs or benefits, of

any specific changes that may be

suggested.

Done, at Washington, D.C., on December

21, 1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95–31393 Filed 12–26–95; 3:36 pm]

BILLING CODE 3410–DM–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR PART 319 and 381

[Docket No. 92–024P]

RIN: 0583–AB51

Food Standards: Requirements for

Processed Meat and Poultry Products

Named by Use of an Expressed

Nutrient Content Claim and a

Standardized Term

AGENCY: Food Safety and Inspection

Service, USDA.