67490 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 71, 170, and 171

[Docket No. 95N–0220]

RIN 0910–AA66

Substances Approved for Use in the

Preparation of Meat and Poultry

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations governing the

review of petitions for the approval of

food and color additives and substances

generally recognized as safe (GRAS) to

provide for joint review of such

petitions by the Food Safety and

Inspection Service (FSIS), U.S.

Department of Agriculture (USDA),

when meat or poultry product uses are

proposed. By agreement between USDA

and FDA, such listings would eliminate

the need for a separate FSIS rulemaking

to allow the use in meat and poultry

products of FDA-approved substances.

DATES: Written comments by March 14,

1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

George H. Pauli, Center for Food Safety

and Applied Nutrition (HFS–200), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3090.

SUPPLEMENTARY INFORMATION:

I. Background

FDA, under the Federal Food, Drug,

and Cosmetic Act (the act), is

responsible for regulating foods

generally. FSIS, under the Federal Meat

Inspection Act (FMIA) and the Poultry

Products Inspection Act (PPIA),

regulates products consisting wholly or

in part of meat or poultry.

Over the years, FDA has generally

deferred to FSIS in matters concerning

the regulation of meat and meat food

products (hereinafter referred to

collectively as meat products) and

poultry products, despite FDA’s broad

jurisdiction over all food. This approach

is consistent with the proposition that

in cases of possible jurisdictional

overlap, an agency with a broad grant of

statutory authority will normally defer

to an agency with a more specific grant

of authority. FSIS has primary

jurisdiction over meat and poultry

products and is tasked with ensuring

that all those products are inspected

before they are permitted in commerce.

FSIS regulations and guidelines govern

all aspects of meat and poultry products

that are subject to such inspection.

These include regulations and guidance

on substances that may be added to

those products.

Since the 1958 Food Additives

Amendment to the act, FSIS has come

to rely on FDA in most matters

concerning the safety of food and color

additives and other substances that may

be used in meat and poultry products.

FDA regulates food additives and color

additives through a premarket approval

system established respectively by

sections 409 and 721 of the act

(21 U.S.C. 348 and 379e). FDA has

developed the scientific staff, the

institutional expertise, and the

regulatory structure to ensure the safety

of substances that may be added to

foods. The act requires that both food

additives and color additives be shown

to be safe before marketing

(21 U.S.C. 348(c)(3) and 379e(b)(4)). In

addition, FDA may not approve any use

of a food additive that would ‘‘promote

deception of the consumer * * * or

would otherwise result in adulteration

or misbranding of food * * * ’’ (21

U.S.C. 348(c)(3)(B)). Similarly, a color

additive must also be shown to be

suitable for its intended use (21 U.S.C.

379e(b)(1)).

Over the years, the two agencies have

cooperated on food ingredient issues on

an as-needed, substance-specific, and

case-by-case basis. Nonetheless, because

of their different regulatory needs, the

two agencies’ regulations governing the

use of these substances in foods are cast

in formats and terms that are not fully

consistent with one another. This

absence of consistency causes difficulty

and inconvenience to persons who need

to refer to both agencies’ regulations on

approved substances and substance

uses.

Furthermore, it is not clear from the

regulations where one agency’s

jurisdiction ends and the other’s begins.

The public frequently sends FSIS

requests for approval of the use of

substances in food that must be referred

to FDA, and sends FDA requests

involving meat or poultry uses that must

be referred to FSIS.

Finally, FSIS’s current regulations

require that those seeking approval of a

substance for use in or on meat or

poultry products first establish that the

substance is safe for the intended use

under section 409 or section 721 of the

act, and second, that it is suitable for the

intended use under the FMIA or PPIA

(9 CFR 318.7(a) and 381.147(f)). As a

result, both agencies conduct separate,

sequential reviews and rulemakings

before a new meat or poultry use can be

permitted. Many years can elapse

between the time a manufacturer

petitions FDA for the approval of a food

additive or a color additive under the

act and the appearance in FSIS’s

regulations of approval for meat and

poultry uses.

FDA and FSIS have also concluded

that their respective regulations

concerning food and color additives and

other substances that may be added to

meat and poultry products should be

more consistent with one another and

easier to use and access.

II. The Proposal

This proposed rule, together with an

FSIS proposed rule appearing elsewhere

in this issue of the Federal Register,

would require a single petition, joint

reviews, and a single rulemaking

procedure to replace the current time

consuming, duplicative, sequential

rulemaking procedures governing the

use in meat or poultry products of food

additives, color additives, and GRAS

substances. It is intended to clarify the

two agencies’ responsibilities and

regulatory interests. Future FSIS listings

for meat and poultry uses would be

harmonized with those of FDA and

incorporated into FDA’s regulations in

Title 21 of the Code of Federal

Regulations (CFR), providing a basis for

the eventual elimination of FSIS’s

separate listings from Title 9 CFR.

Substances would be authorized for

use in products under the jurisdiction of

FSIS on the basis of FDA’s regulations

permitting such uses. For a substance

not authorized for meat or poultry use

under existing FDA regulations, only

one petition for rulemaking—to FDA—

would be required. Future FDA food

additive, color additive, and GRAS

substance listings would specify any

approved meat or poultry product uses,

and any conditions of such uses, in

accord with FSIS recommendations, to

the extent those recommendations are

consistent with the act.

Substances whose use is GRAS,

however, are exempt from the premarket

approval requirements of the act and

need not be listed in FDA’s regulations

in 21 CFR. For a substance that is not

affirmed by FDA as GRAS or otherwise

listed in part 182 or 184 (21 CFR part

182 or 184) of FDA’s regulations, or for

a GRAS substance listed by FDA for

general food use, where meat or poultry

uses are neither specified nor

prohibited, FSIS would continue to
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67491

consider a manufacturer’s basis for

claiming GRAS status and suitability for

use in meat or poultry products. In such

cases, FSIS would make the

determination in consultation with FDA

as needed to ensure that appropriate

advice is given and that FDA has notice

of the determination.

This proposal would require, and lead

to, greater harmonization, i.e., closer

and more consistent cooperation,

between FDA and FSIS. The agencies

propose to enter into a memorandum of

understanding (MOU) concerning the

specifics of the agencies’ working

relationship under the proposed

regulations. A draft of the MOU is

appended to the FSIS proposal

appearing elsewhere in this issue of the

Federal Register.

FSIS and FDA believe that the public

will be better served by having all

permitted uses for food additives, color

additives, and GRAS substances

consolidated in one place—in Title 21

CFR—and intend to work toward that

end. However, existing regulations on

specific substances and substance uses

in Titles 9 and 21 CFR would not be

immediately affected by this proposal.

Because of resource constraints, current

FDA regulations would be amended to

accommodate meat and poultry uses

only in response to a food additive,

color additive, or GRAS petition. FSIS

will review its listings accordingly and

eliminate those that are redundant with

FDA’s Title 21 listings.

This proposed rule would amend

FDA regulations to provide for: (1)

Specifying any meat, meat food product,

or poultry product uses of substances

approved by FDA for food use and listed

in 21 CFR; and (2) petitioning FDA for

listing in 21 CFR of substances intended

to be used in meat, meat food products,

or poultry products. FDA’s regulations

would be amended so that all petitions

to permit new substances, new uses, or

new use levels of substances in meat,

meat food products, or poultry products

would be filed only with FDA. FDA’s

regulations governing color additive

petitions, petitions to affirm substances

as GRAS, and food additive petitions in

parts 71, 170, and 171 (21 CFR parts 71,

170, and 171), respectively, would be

revised to provide for joint review by

FSIS of petitions filed with FDA that

propose use of the substance in meat or

poultry products. (In the agencies’ view,

it is the petitioner’s burden to identify

the intended meat and poultry uses of

a substance.)

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Analysis of Impacts

FDA has examined the impacts of the

proposed rule to amend 21 CFR parts

71, 170, and 171 under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health, and safety

effects; distributive impacts; and

equity). The Regulatory Flexibility Act

requires analysis of options for

regulatory relief for small entities.

The principal benefit of this proposed

rule is to eliminate duplicative Federal

effort. Under the proposed amendments

and amendments FSIS is concurrently

proposing to its regulations published

elsewhere in this issue of the Federal

Register, separate petitions to FSIS for

use of substances in meat or poultry

products would no longer be required.

Obtaining approval for the use in meat

and poultry products of new substances

or for new uses of previously approved

substances would be simpler, faster, and

less costly for both industry and the

Federal Government than under the

current system.

With this proposed rule, those

substances not authorized for meat and

poultry use under existing FDA

regulations would require only one

petition for rulemaking—to FDA. (For a

substance that is not affirmed as GRAS

by FDA or otherwise listed in 21 CFR

part 182 or 184, or a substance listed by

FDA for general food use, FSIS would

continue to consider the manufacturer’s

basis for claiming GRAS status of the

substance and its suitability for a

specified use in meat or poultry

products.) Furthermore, all users of the

Federal regulations concerning the

addition of substances to foods should

benefit by having fewer, clearer

regulations. Thus, there would be a

reduction in the duplication of effort

and attendant costs for all concerned.

Therefore, FDA finds that this

proposed rule would not have a

significant adverse economic impact. In

addition, FDA certifies that there is not

a significant impact on a substantial

number of small entities.

Nevertheless, this proposed rule has

been deemed by the Office of

Information and Regulatory Affairs

(OIRA) of the Office of Management and

Budget to be a significant regulatory

action as defined by section 3(f)(4) of

Executive Order 12866 because it raises

novel legal and/or policy issues arising

out of the President’s priorities, namely

the reinvention of government and

regulatory reform initiatives. Therefore,

this proposed rule has been formally

reviewed by OIRA in accordance with

the provisions of Executive Order

12866.

V. Paperwork Reduction Act of 1995

This proposed rule contains

information collections which are

subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(Pub. L. 104–13). Information collection

requirements have been approved by

OMB for color additive petitions,

petitions to affirm substances as GRAS,

and food additive petitions under OMB

Nos. 0910–0185, 0910–0132, and 0910–

0016, respectively. FDA has determined

that the proposed rulemaking would

entail no new information collection

from the regulated industry or other

private entities. Persons seeking Federal

Government approval of substances for

use in meat or poultry foods would not

have to submit any information not

currently required for approval.

However, such persons would only have

to submit petitions to FDA, rather than

to both FDA and FSIS, as they do now.

Thus, a current, duplicative information

collection requirement would be

eliminated.

FDA requests comments regarding its

tentative conclusions on the paperwork

burden.

VI. Comments

Interested persons may, on or before

March 14, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects

21 CFR Part 71

Administrative practice and

procedure, Color additives, Confidential

business information, Cosmetics, Drugs,

Reporting and recordkeeping

requirements.
67492 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

21 CFR Part 170

Administrative practice and

procedure, Food additives, Reporting

and recordkeeping requirements.

21 CFR Part 171

Administrative practice and

procedure, Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 71, 170, and 171 be

amended as follows:

PART 71—COLOR ADDITIVE

PETITIONS

1. The authority citation for 21 CFR

part 71 continues to read as follows:

Authority: Secs. 201, 402, 409, 501, 505,

506, 507, 510, 512–516, 518–520, 601, 701,

721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 342, 348, 351,

355, 356, 357, 360, 360b–360f, 360h–360j,

361, 371, 379e, 381); secs. 215, 351 of the

Public Health Service Act (42 U.S.C. 216,

262).

2. Section 71.1 is amended in

paragraph (c) in the petition by revising

the introductory paragraph preceding

paragraph A., and by adding new

paragraph (j) to read as follows:

§ 71.1 Petitions.

* * * * *

(c) * * *

Attached hereto in triplicate

(quadruplicate, if intended uses include use

in meat, meat food product, or poultry

product), and constituting a part of this

petition are the following:

* * * * *

(j)(1) If intended uses of the color

additive include uses in meat, meat food

product, or poultry product subject to

regulation by the U.S. Department of

Agriculture (USDA) under the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) or Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et

seq.), FDA shall, upon filing of the

petition, forward a copy of the petition

or relevant portions thereof to the Food

Safety and Inspection Service, USDA,

for simultaneous review under the PPIA

and FMIA.

(2) FDA will ask USDA to advise

whether the proposed meat and poultry

uses comply with the FMIA and PPIA,

or if not, whether use of the substance

would be permitted in products under

USDA jurisdiction under specified

conditions or restrictions.

3.Section 71.20 is amended by adding

new paragraph (a)(3) to read as follows:

§ 71.20 Publication of regulation.

* * * * *

(a) * * *

(3) The regulation shall list any use or

uses in meat, meat food product, or

poultry product subject to the Federal

Meat Inspection Act (FMIA)(21 U.S.C.

601 et seq.) or Poultry Products

Inspection (PPIA)(21 U.S.C. 451 et seq.)

for which the color additive has been

found suitable and for which it may

safely be employed.

* * * * *

PART 170—FOOD ADDITIVES

4. The authority citation for 21 CFR

part 170 continues to read as follows:

Authority: Secs. 201, 401, 402, 408, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 342, 346a, 348, 371).

5. Section 170.35 is amended by

redesignating paragraphs (c)(3) through

(c)(6) as paragraphs (c)(4) through (c)(7),

respectively, and by adding new

paragraph (c)(3) to read as follows:

§ 170.35 Affirmation of generally

recognized as safe (GRAS) status.

* * * * *

(c) * * *

(3)(i) If intended uses of the substance

include uses in meat, meat food

product, or poultry product subject to

regulation by the U. S. Department of

Agriculture (USDA) under the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) or Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et

seq.), FDA shall, upon filing of the

petition, forward a copy of the petition

or relevant portions thereof to the Food

Safety and Inspection Service, USDA,

for simultaneous review under the PPIA

and FMIA.

(ii) FDA will ask USDA to advise

whether the proposed meat and poultry

uses comply with the FMIA and PPIA,

or if not, whether use of the substance

would be permitted in products under

USDA jurisdiction under specified

conditions or restrictions.

* * * * *

PART 171—FOOD ADDITIVE

PETITIONS

6. The authority citation for 21 CFR

part 171 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

7. Section 171.1 is amended in

paragraph (c) in the petition by revising

the introductory paragraph preceding

paragraph A., and by adding new

paragraph (n) to read as follows:

§ 171.1 Petitions.

* * * * *

(c) * * *

Attached hereto, in triplicate

(quadruplicate, if intended uses include use

in meat, meat food product, or poultry

product), and constituting a part of this

petition, are the following:

* * * * *

(n) (1) If intended uses of the food

additive include uses in meat, meat food

product, or poultry product subject to

regulation by the U.S. Department of

Agriculture (USDA) under the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451, et seq.) or Federal Meat

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

seq.), FDA shall, upon filing of the

petition, forward a copy of the petition

or relevant portions thereof to the Food

Safety and Inspection Service, USDA,

for simultaneous review under the PPIA

and FMIA.

(2) FDA will ask USDA to advise

whether the proposed meat and poultry

uses comply with the FMIA and PPIA,

or if not, whether use of the substance

would be permitted in products under

USDA jurisdiction under specified

conditions or restrictions.

8. Section 171.100 is amended by

redesignating paragraph (b) as paragraph

(c) and by adding new paragraph (b) to

read as follows:

§ 171.100 Regulation based on petition.

* * * * *

(b) The regulation shall describe the

conditions under which the substance

may be safely used in any meat product,

meat food product, or poultry product

subject to the Federal Meat Inspection

Act (FMIA) (21 U.S.C. 601 et seq.) or the

Poultry Products Inspection Act (PPIA)

(21 U.S.C. 451 et seq.).

* * * * *

Dated: October 11, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31491 Filed 12–26–95; 3:37 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 102, 130, 131, 133, 135,

136, 137, 139, 145, 146, 150, 152, 155,

156, 158, 160, 161, 163, 164, 165, 166,

168, and 169

[Docket No. 95N–0294]

Food Standards of Identity, Quality and

Fill of Container; Common or Usual

Name Regulations; Request for

Comments on Existing Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.