Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67459

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310, 318, 319, and 381

[Docket No. 88–026P]

RIN 0583–AB02

Substances Approved for Use in the

Preparation of Meat and Poultry

Products

AGENCY: Food Safety and Inspection

Service (FSIS), USDA.

ACTION: Proposed rule.

SUMMARY: FSIS is proposing to amend

the Federal meat and poultry inspection

regulations to harmonize and improve

the efficiency of the procedures used by

FSIS and the Food and Drug

Administration (FDA) for reviewing and

approving the use of substances in meat

and poultry products. Under the

proposed procedures, FSIS would no

longer issue its own regulations listing

substances it finds suitable for use in

meat and poultry products. Instead, by

agreement between USDA and the FDA,

future FDA regulations would specify

whether a substance approved for use in

foods under the Federal Food, Drug, and

Cosmetic Act (FFDCA) may be used in

or on meat or poultry products. Current

FDA regulations that approve the use of

substances in foods generally and do not

preclude meat and poultry uses will

confer authority to use such substances

in meat and poultry products unless

expressly prohibited by USDA

regulation.

Requests for meat and poultry uses of

substances not permitted under title 9 or

title 21 of the Code of Federal

Regulations (CFR) would have to be

made to FDA in the form of a petition

for FDA approval. FDA is

simultaneously publishing in this issue

of the Federal Register a proposal that

would amend the FDA regulations

governing the review of petitions for the

approval of food additives to provide for

simultaneous review of such petitions

by FSIS when meat or poultry product

uses are indicated. This would permit

FDA listings to specify whether, and if

so under what conditions, such

substances may be used in USDAinspected meat and poultry products.

Such listings would eliminate the need

for separate FSIS rulemaking.

FSIS would limit any future,

substance-specific rulemaking to

prohibitions or limitations on meat or

poultry uses of specific substances that

may be necessary to protect the public

under the Federal Meat Inspection Act

(FMIA) or Poultry Products Inspection

Act (PPIA). FSIS would continue to

provide evaluations upon request as to

whether substances permitted for

general use under current regulations

are suitable for specific uses in meat and

poultry products.

FSIS proposes to adopt the position

that substances that are listed in title 21,

CFR, Parts 182 and 184, as generally

recognized as safe (GRAS) for use in

food generally, with no limitation other

than good manufacturing practice,

would be accepted by USDA as GRAS

for use in meat, meat food products, and

poultry products generally, unless

otherwise restricted for such use by

regulation in title 9, CFR. Other GRAS

substances currently permitted for

general food use would be evaluated by

FSIS as to their suitability for specified

uses in meat food products and poultry

products on a case-by-case basis, in

consultation with FDA as appropriate.

DATES: Comments must be received by

February 27, 1996.

ADDRESSES: Written comments to: Diane

Moore, Docket Clerk, Room 4352, South

Agriculture Building, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250.

Oral comments, as provided under the

Poultry Products Inspection Act (PPIA),

should be directed to Mr. Ralph Stafko

at (202) 720–8168. (See also

‘‘Comments’’ under SUPPLEMENTARY

INFORMATION.)

FOR FURTHER INFORMATION CONTACT: Mr.

Ralph Stafko, Deputy Director, Policy

Evaluation and Planning Staff, Food

Safety and Inspection Service, U.S.

Department of Agriculture, Washington,

DC 20250; (202) 720–8168.

SUPPLEMENTARY INFORMATION:

Comments

Interested persons are invited to

submit comments concerning this

proposal. An original and two copies of

written comments should be sent to the

Docket Clerk’s office at the address

shown above and should refer to docket

number 88–026P. Any person desiring

opportunity for oral presentation of

views, as provided under the PPIA,

should make such request to Mr. Stafko

at (202) 720–8168 so that arrangements

may be made for such views to be

presented. Copies of all comments

submitted in response to this proposal

will be available for public inspection in

the office of the Docket Clerk between

8:30 and 1:00 a.m. and between 2:00

and 4:00 p.m., Monday through Friday.

Background

FDA and FSIS are both regulatory

agencies mandated to protect consumers

from adulterated or misbranded food

products. FDA, under the FFDCA, is

responsible for regulating foods

generally. FSIS, under the FMIA and the

PPIA, regulates products consisting

wholly or in part of meat or poultry.

Products regulated by FSIS, for the

most part, include those containing at

least 2 percent cooked or 3 percent raw

poultry or red meat. Products that

contain meat or poultry only in

condimental quantities or that

historically have not been regarded as

meat or poultry products are not

regulated under the inspection Acts.

Examples of such products are some

cheese spreads with meat, close-faced

sandwiches, bouillon cubes, and dried

or dehydrated meat soups.

Even though FDA and FSIS have a

common food safety mission, they have

differing statutory mandates and carry

out their individual statutory mandates

in different ways. FDA relies primarily

on the promulgation of and compliance

with regulations to implement its

mandate concerning substances

intentionally added to food, such as

food additives and color additives. FDA

also relies on inspections of food

manufacturing and storage facilities to

enforce its statutory mandates relating

to sanitation and conditions of

manufacture and storage. Detection and

seizure of violative products, and

sanctions imposed on producers or

manufacturers responsible for violations

are based on evidence that violative

product (or a component of the product)

was introduced into interstate

commerce.

The FMIA and PPIA (21 U.S.C. 601 et

seq.; 21 U.S.C. 451 et seq.) require that

meat and poultry products be inspected,

and USDA inspection program

personnel inspect such products before

the products are placed in commerce.

The USDA mark of inspection is placed

only on those products found by USDA

to be unadulterated and properly

labeled. Thus, FSIS’s primary

enforcement activity is the conduct of

inspection activities designed to prevent

the production and distribution of

adulterated or misbranded products.

FSIS regulations on products under its

jurisdiction are enforced primarily by

inspectors and inspection program

support staff on a plant-by-plant basis.

Inplant FSIS personnel may retain

suspect product and condemn

adulterated product. In egregious cases,

FSIS may withdraw inspection from

plants.

This different approach to regulation,

based on the statutes governing the

activities of the respective agencies, has

required FSIS and FDA, and their

predecessor agencies, to work together

closely to minimize the potential for
67460 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

conflict, duplication of effort, or gaps in

their regulatory schemes that could

result in inadequate or inappropriate

regulation.

Over the years, FDA has generally

deferred to FSIS in matters concerning

the regulation of meat, meat food

products, and poultry products, despite

its 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

employs veterinarians, trained

inspectors, and technical support staff

to carefully and continuously oversee

the production of these products. FSIS

regulations and guidelines govern all

aspects of meat and poultry food

product 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 FFDCA, 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 foods—including meat and

poultry products. 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.

Over the years, FDA and FSIS have

cooperated on food-ingredient issues on

an as-needed, substance-specific, caseby-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

inconsistency causes difficulty and

inconvenience to persons who need to

refer to both agencies’ regulations on

approved substances and approved

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 the use of new substances

or new uses of substances 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 substances used in meat or

poultry products be listed in FSIS

regulations for those uses. The

regulations further require that those

wishing to establish a rule permitting

meat or poultry product uses of a

substance first must establish that it is

safe for the intended use under the

FFDCA, 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

reviews and undertake separate

rulemakings, sequentially, before a new

meat or poultry use of a substance can

be permitted. This proposed rule and a

concurrent FDA proposed rule,

appearing elsewhere in this issue of the

Federal Register, are intended to

harmonize and simplify the agencies’

regulations on food ingredients by

allowing FSIS to rely on FDA’s listings

for food ingredients, and to provide a

basis for the eventual elimination of

FSIS’s separate listings from the CFR.

There would be a single petition, joint

reviews, and a single rulemaking

procedure, as well as continuing

consultation on related issues, to

replace the current time-consuming,

duplicative, sequential rulemaking

procedures. The agencies would enter

into a Memorandum of Understanding

(MOU) concerning the specifics of the

agencies’ working relationship. A draft

of this MOU appears as an appendix to

this notice of proposed rulemaking.

The following review of the laws and

regulations of the two agencies explains

in more detail the agencies’ relationship

in this area of regulation.

History of Food Additive Regulation

The Food and Drugs Act of 1906

declared that food containing ‘‘any

added poisonous or other added

deleterious ingredient which may

render such article injurious to health’’

was adulterated (PL 59–384, 34 Stat.

770), and that sale of adulterated food

was a violation of law. The Meat

Inspection Act, passed at the same time

as companion legislation, mandated

Federal inspection of meat and meat

food products. Responsibility for

implementing and enforcing both these

laws was vested in the Secretary of

Agriculture.

In 1938, the FFDCA expanded the

scope of the Food and Drugs Act by,

among other things, prohibiting the sale

of foods that may be adulterated by

substances other than added

ingredients, such as by environmental

contaminants, that could render the

food injurious to the health of the

consumer.

In 1940, responsibility for

implementation and enforcement of the

FFDCA was removed from the Secretary

of Agriculture and was vested in the

Administrator of the Federal Security

Agency, which later became the

Department of Health, Education, and

Welfare (today, the Department of

Health and Human Services). However,

the authority to implement the meat

inspection system was retained by

USDA.

By the 1950’s, it had become apparent

that there were certain limitations in the

authorities provided by the FFDCA.

Among these was the lack of a provision

requiring industry to pretest substances

intended for use in food to determine

the safety of such use. Also, in an

enforcement action against a violative

food, the burden of proof was on the

Government to show that use of a food

additive caused the food to be

adulterated or misbranded.

To correct these and other problems,

the Food Additives Amendment was

passed in 1958. Processors were

thenceforth required to prove that food

additives were safe for their intended

use before they could be used in food.

FDA was required to determine the

safety of food additives and regulate

their use in foods.

The Food Additives Amendment of

1958 applies to substances added to all

foods, including meat and poultry

products subject to USDA inspection

under the FMIA and the PPIA. The

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

PPIA (21 U.S.C. 451 et seq.) give USDA

primary jurisdiction over meat and

poultry products to a ensure product

entering commerce is not adulterated or

misbranded. FSIS has interpreted the

Food Additives Amendment as giving

FDA primary jurisdiction for the

approval of food additives for use in

meat and poultry products, while not

precluding continued exercise of USDA/

FSIS jurisdiction to further regulate the

use of those substances in meat and

poultry products under the FMIA and

PPIA.

Section 1(m)(2) of the FMIA (21

U.S.C. 601(m)(2)) and section 4(g)(2) of

the PPIA (21 U.S.C. 453(g)(2)) provide

the Secretary of Agriculture with

authority to regulate the use of food and

color additives in meat and poultry

products. Section 1(m)(2)(C) of the

FMIA and section 4(g)(2)(C) of the PPIA

provide that any meat or poultry

carcass, part, or product is adulterated

‘‘if it bears or contains any food additive

which is unsafe within the meaning of

section 409 of the Federal Food, Drug,

and Cosmetic Act (FFDCA).’’ Under

section 409 of the FFDCA (21 U.S.C.

348), all food additives are deemed

unsafe unless the FDA finds, by

regulation, that they are safe for a

particular use. Section 1(m)(2)(D) of the

FMIA (21 U.S.C. 601(m)(2)(D)) and

section 4(g)(2)(D) of the PPIA (21 U.S.C.

453(g)(2)(D)) provide that any meat or

poultry carcass, part, or product is

adulterated ‘‘if it bears or contains any

color additive which is unsafe within

the meaning of section 721 of the
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67461

FFDCA.’’ Under section 721 of the

FFDCA (21 U.S.C. 379e), all color

additives are deemed unsafe unless the

FDA finds, by regulation, that they are

safe for a particular use. Section 1(m)(2)

of the FMIA (21 U.S.C. 601(m)(2)) and

section 4(g)(2) of the PPIA (21 U.S.C.

453(g)(2)) also provide that the Secretary

of Agriculture may issue regulations

prohibiting the use of a food additive or

color additive in a meat or poultry

article in establishments receiving

Federal meat or poultry inspection

services.

The Secretary of Agriculture’s

authority under the FMIA to prohibit

the use of substances in meat products

that are otherwise permitted in foods by

FDA was tested in Chip Steak Co. v.

Clifford Hardin (332 F. Supp. 1084 (N.D.

Cal. 1971), aff’d., 467 F.2d 481 (9th Cir.

1972)). The plaintiffs demanded

injunctive relief from the prohibition at

9 CFR 318.7(d)(2) against the use of

sorbic acid and sorbates in cooked

sausage. The court held that the

legislative history of the FMIA showed

that it was the intent of Congress to vest

the Secretary of Agriculture with the

authority to prohibit the use of

substances in meat food products

notwithstanding their designation as

GRAS. The court noted that under the

FMIA, the Secretary had the power to

prohibit a substance for use in meat and

meat products even if the substance is

not adulterative under the food additive

provisions of the FFDCA. Thus, the

Secretary of Agriculture could impose

restrictions for food ingredients in meat

and meat food products that exceeded

restrictions imposed by the Secretary of

HHS.

At about the same time that this case

was in progress, the Agency was

involved in rulemaking to implement

the Wholesome Meat Act (81 Stat. 584)

and the Wholesome Poultry Products

Act (82 Stat 791–808). Among the

provisions in the new regulations were

requirements for listing substances in

the 9 CFR regulations before they could

be used in meat, meat food, or poultry

products. The relevant provisions, at 9

CFR 318.7(a)(1) and 381.147(f)(1) in the

existing regulations, were adopted

October 3, 1970, and May 16, 1972,

respectively. They had the effect, along

with the favorable district court

decision, of strengthening the

Administrator’s authority to control the

use of substances in meat and poultry

products. Nothing in the current

proposal would diminish that authority.

FDA Regulations

Meat and poultry product ingredients

are subject to regulation by the FDA

under the FFDCA. Such ingredients may

be food additives, substances that are

generally recognized as safe (GRAS) for

use in food, color additives, or

ingredients covered by prior sanctions.

The FFDCA defines a food additive as

‘‘any substance the intended use of

which results or may reasonably be

expected to result, directly or indirectly,

in its becoming a component or

otherwise affecting the characteristics of

any food * * *’’ (21 U.S.C. 321(s)).

Anyone wishing to use a new food

additive must petition the FDA and

obtain approval before using the

substance in food. The sponsor must

provide FDA with information

demonstrating safety under the

proposed conditions of use. The extent

or amount of the data submitted will

depend primarily on the nature of the

substance and its intended uses.

FDA’s food additive regulations are

codified in several parts of title 21 of the

Code of Federal Regulations. Part 170

contains general provisions. Part 171

specifies how food additive petitions are

submitted and processed. Part 172 lists

food additives approved for direct

addition to food. Part 173 lists food

additives permitted in food, e.g.,

enzyme preparation, microorganisms,

solvents, and lubricants. Part 179 covers

sources of radiation used to process

food, included in the statutory

definition of a food additive (21 U.S.C.

321(s)). Part 180 lists certain food

additives to be used on an interim basis

until such time as studies can be

completed and data made available to

resolve those safety issues if the

Commissioner of Food and Drugs

determines that the continued use of

those substances presents no public

health concern.

The definition of ‘‘food additive’’

excludes certain substances that are

‘‘prior sanctioned,’’ ‘‘generally

recognized as safe,’’ or ‘‘color additive’’

substances. Prior sanctioned ingredients

are those used in accordance with

explicit sanctions or approvals granted

prior to the enactment of the Food

Additives Amendment in 1958. These

prior sanctions may have been granted

by FDA under the FFDCA (21 U.S.C.

321(s)(4)) or by USDA under the FMIA

or the PPIA. Such ingredients, e.g.,

nitrites used in cured pork products, are

exempt from the food additive

provisions of the FFDCA.

A second exemption from the

definition of ‘‘food additive’’ is

‘‘generally recognized as safe’’ or

‘‘GRAS’’ substances. These are defined

by the FFDCA as substances generally

recognized as safe among experts

qualified by scientific training and

experience to evaluate their safety.

Designation as GRAS can come about in

either of two ways: (1) By demonstration

of common use of the substance in food

prior to 1958 or (2) by scientific

procedures.

GRAS substances include a variety of

common food ingredients. Although

FDA advises that it would be

impracticable to list all substances that

are generally recognized as safe for their

intended use, many GRAS substances

are specifically listed in Part 182 of title

21. In addition, FDA has formally

affirmed certain substances as GRAS,

and has listed their GRAS uses in Part

184 of title 21.

FDA may also find that a substance or

a particular use of a substance is not

generally recognized by qualified

experts as safe for use in food. Such

substances or uses may continue to be

used under an ‘‘interim food additive’’

regulation (21 CFR 180) while specified

studies are performed to resolve the

safety question.

A ‘‘color additive’’ is a material that,

‘‘ * * * when added or applied to a

food, drug, * * * or cosmetic, or to the

human body or any part thereof, is

capable * * * of imparting color

thereto’’ (21 U.S.C. 321(t)). As with food

additives, only those color additives

listed for use in food may be so used.

Petitions must be submitted to FDA for

any new color additive or uses along

with appropriate safety data and other

pertinent information.

FSIS Regulations

FSIS inspectors oversee the

production of meat and poultry

products and must assure that product

is not adulterated or misbranded by the

addition of unsafe or otherwise

improper ingredients, or by

contamination with substances used for

other purposes in the plant. To assist in

this activity, FSIS headquarters staff

reviews and approves substances that

may be used in meat and poultry

products regulated under the FMIA and

PPIA.

Substances added directly to products

are strictly regulated. FSIS regulations

provide that no substance may be used

in the preparation of any meat or

poultry product unless the use of the

substance is approved by the

Administrator and listed in the

regulations, or the Administrator has

approved use of the substance in a

specific case (9 CFR 318.7(a)(1) and

381.147(f)(1)). The tables of substances

in 9 CFR 318.7 and 381.147 list a variety

of substances along with their general

classification (e.g., ‘‘antioxidant’’), their

intended function, the categories of

products in which they may be used,

and the permitted use levels. The tables

supplement or complement the product
67462 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

standards set forth in 9 CFR 319 and 9

CFR 381.155–171. In order to add a new

substance to these listings, increase the

permitted use level, or expand the

category of products in which an

approved substance may be used, FSIS

amends these listings by notice-andcomment rulemaking.

FSIS provides guidance on the

regulatory status of substances used in

inspected establishments. In the course

of day-to-day operations, FSIS staffs

must respond to inquiries, from

inspectors and others, about new uses of

substances already approved, or the use

of new substances not previously

approved, and must determine whether

such substances are safe and suitable

before they are used in specific meat

food or poultry products. Responses to

these inquiries generally are made after

review by FSIS’s Product Assessment

Division (PAD), or, if appropriate, the

Facilities, Equipment, and Sanitation

Division (FESD).

The PAD will assess the safety and

suitability of direct and indirect

additives. Its assessment involves

primarily a determination of whether

the substance has been previously

approved for safety by FDA or USDA. If

the substance is a food additive or color

additive the safe use of which has not

been approved by FDA, the inquiring

party is directed to petition FDA. If it is

a GRAS substance or is asserted to be

prior-sanctioned, a determination of its

status is made by PAD, in consultation

with FDA, if appropriate.

PAD will also determine the

functionality of substances proposed to

be added to meat or poultry products,

and reviews data on amounts needed to

achieve the intended technical effect.

PAD looks at the consistency of the

proposed use with standards of identity

that may apply, and whether the

substance may be misused in some way

to make product adulterated or

misbranded. The Division will restrict

uses as appropriate to prevent

adulteration or misbranding.

PAD reviews labels for compliance

with FSIS regulations, including

ingredient and additive requirements,

and must approve them before they are

used on the packaging of meat and

poultry products (9 CFR 317.4, 381.132).

The Division is thus in a position to

monitor, by looking at formulations, the

ingredients intended to be used with

each product. In addition, the Division

conducts a voluntary review of

proprietary mixes intended for use in

meat food or poultry products.

Similarly, PAD reviews food-contact

materials, such as processing aids,

scalding agents, and chill tank

additives. If these substances are found

to be food additives or color additives

as defined by the FFDCA, they also

must be approved by FDA before USDA

will approve them for use with

inspected products. Other substances,

some of which are not regulated under

the FFDCA’s food additive provisions,

are nonetheless reviewed by FSIS on an

‘‘as needed’’ basis, before their use in or

about inspected products is sanctioned.

Inspectors, meat and poultry processors,

food chemical and equipment

manufacturers, and others require

guidance on whether inspectors may

view substances as potential adulterants

of inspected product. Prior review by

FSIS’s technical staff normally will

resolve the question. For example,

review and approval for use in official

establishments of specific sanitizing and

cleaning agents, and of food-contact

equipment and utensils, is done by the

FESD.

FDA Rulemaking Processes

Current FDA rulemaking for food

additive and GRAS listings is essentially

a four-part process:

1. A petition for use of a new food

additive, a new use or use level of an

existing food additive is received with

data demonstrating the safety of the

intended use of the substance, or a

petition for affirmation of a substance as

GRAS is received with data or

information demonstrating that the

substance is GRAS;

2. A notice of proposed rulemaking

(or a notice of the filed petition—the

functional equivalent of a proposed

rule) is published in the FR;

3. A review for safety and technical

effect of the new substance, new use, or

new use level of the substance is

conducted by the FDA; and,

4. A final rule is published if FDA

determines that the food additive use or

use level is safe or if the substance is

GRAS.

FDA listings normally do not specify

whether permitted uses include uses in

meat and poultry products or, if so,

what conditions or restrictions apply to

such uses. Because USDA has always

(prior to the 1958 food additive

amendments) regulated the safe use of

substances in meat and poultry

products, and because of the need for

inspected establishments, inspection

program personnel and others to have

uniform guidance on what substances

may be added to inspected product,

USDA has historically listed such

substance uses in its own regulations in

title 9 of the CFR.

FSIS Rulemaking Procedures

Before July 1983, FSIS conducted its

own notice-and-comment rulemaking,

as needed, for the listing of substances

approved for use in meat and poultry

products. Industry representatives

complained that these FSIS rulemakings

largely duplicate FDA rulemaking. They

asserted that FDA’s food additive and

GRAS substance affirmation

proceedings address and fully resolve

all questions regarding safety, if not

functionality, of ingredients intended to

be used in meat and poultry products.

They argued that additional rulemaking

by FSIS generated needless delays and

expense, and often resulted in the

withholding of ingredients from the

marketplace for months or even years

after all serious questions of safety had

been resolved.

Furthermore, notice-and-comment

rulemaking by FSIS duplicated FDA’s

rulemaking (concerning safety),

resulting in needless expenditure of

USDA resources. FSIS concluded that

these complaints had merit and that, if

a substance was already listed in title

21, the safety of such uses had, by law,

already been determined by competent

authority. The addition of a substance to

title 9 should not require a full

reassessment for the safety of such use

by USDA. For those reasons, FSIS

proposed to amend its procedures.

In July 1983, FSIS issued a final rule,

‘‘Meat and Poultry Products; Approval

of Substances’’ (proposed June 2, 1982,

47 FR 23941; final July 19, 1983, 48 FR

32749). Under this rule, full notice-andcomment rulemaking was no longer

required for FSIS to list in its

regulations substance uses or use levels

if such uses or use levels were

consistent with those already approved

by FDA. A final rule listing the

substance use or use-levels could be

promulgated without first proposing it

for comment, provided that:

1. The substance was an approved

food additive, color additive, or

substance affirmed as GRAS and

permitted for use in food under title 21;

2. The intended use was in

accordance with any conditions

specified in the FDA approval and

would not violate any other applicable

FDA requirement; and,

3. The Administrator of FSIS

determined:

a. That FSIS concurred with FDA

regarding the safety of the substance;

b. That the available data indicated

that the use of the substance would have

an appropriate technical effect on the

product; and,

c. That the available data indicated

that the substance would be used only

in the amount reasonably required to

accomplish its intended technical effect.

(9 CFR 318.7 and 381.147.)
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67463

All products in which the substance

would be used would be required to be

properly labeled and subject to other

applicable requirements of the meat and

poultry products inspection regulations.

This ‘‘fast-track’’ listing procedure did

result in time and resource savings by

both FSIS and the industry. In August

1988, however, FSIS discontinued its

fast-track procedures because of

concerns that the procedures might not

satisfy the requirements of the

Administrative Procedure Act.

While reverting to notice-andcomment procedures for these

rulemaking proceedings, FSIS also

decided to investigate other means of

reducing the rulemaking burden. FSIS

concluded that duplicative rulemaking

could be avoided if all relevant FMIA

and PPIA issues could be resolved in

the context of the rulemaking

proceeding already required under the

FFDCA and conducted by FDA. This

proposed rule was conceived at that

time, was agreed upon in principle by

FDA, and is now being published for

public comment.

Comments submitted in response to

USDA’s February 25, 1992, notice (57

FR 6483) requesting public comments

on how Departmental regulations can be

improved, updated, or streamlined,

support the Agency’s decision to initiate

this proposed rulemaking. In a March

13, 1992, letter, the American Meat

Institute (AMI), an organization

representing meat packers and

processors of meat and meat food

products, noted that the ‘‘industry’s

current inability to use a wide variety of

safe food ingredients’’ because of the

Agency’s regulatory procedures

prevents the use of least-cost

formulations and impedes product

development. The organization

estimated that ‘‘direct costs associated

with pursuing unnecessary regulatory

changes may exceed $100,000, and such

proceedings generally delay

introductions of new products for

several years.’’

Proposed New Policy

FDA and FSIS have agreed on a

proposed new procedure for regulating

substances intended for use in meat and

poultry products. Under this new

procedure, FSIS inspection program

personnel will permit meat and poultry

use of substances if such uses are

permitted under FDA regulations,

unless otherwise restricted or prohibited

by other FDA regulations or FSIS

regulations.

FSIS will no longer issue regulations

to list substances found by the Agency

to be acceptable for certain uses in meat

and poultry product. Instead, the

Agency will refer to FDA regulations in

order to determine whether a substance

may legally be used in or on a meat or

poultry product.

A key point of this new procedure,

reflecting provisions of the FMIA and

PPIA and the intent of previous

rulemakings, is that substances added to

meat and poultry products, including

GRAS or prior-sanctioned substances,

must be permitted under the FFDCA

and be used consistently with any

applicable regulations.

Under the proposed procedure, FSIS

will be exercising the same authority

and continuing the same reviews that it

has been conducting all along.

FSIS, in carrying out the mandates of

the FMIA and PPIA, has published

regulatory requirements and guidelines

in the areas of facilities, equipment,

sanitation, and production and process

controls that apply to establishments

where meat, meat food, and poultry

products are prepared for distribution in

interstate or foreign commerce. As it has

in the past, when FSIS must decide on

the acceptability of a substance

approved by FDA for general food use,

it will seek FDA concurrence.

In its future regulatory listings of

substances and after consultation with

FSIS, FDA will include, as appropriate,

the amounts and uses of substances

permitted for use in meat and poultry

products.

This is consistent with current FDA

listing format. FDA’s determination of

the acceptability of any food additive or

GRAS substance use is conditioned on

the substance being used in accordance

with GMP. The general regulations for

determining GMP criteria are set forth in

21 CFR part 110. These regulations set

minimum general requirements for

buildings, facilities, equipment,

sanitation, and production and process

controls to be observed in food plants

where products are prepared for

distribution in interstate or foreign

commerce. Further GMP criteria are set

forth in 21 CFR part 172 for food

additives, 21 CFR part 182 for GRAS

substances, and 21 CFR part 184 for

substances affirmed as GRAS.

FSIS’s title 9 listing of authorized

substances is incomplete, inconsistent

with, and duplicative of FDA’s listings.

The Agency plans to eliminate its

current listings over time by

rulemaking, as listings are determined

to be duplicative of FDA regulations.

However, FSIS will retain its own

regulations on specific substance use

prohibitions and will add new

prohibitions as necessary.

To provide guidance to its inspectors,

inspected establishments, and other

interested persons, FSIS will maintain a

comprehensive listing, in its directive

system, of substances authorized for

meat and poultry uses under title 9 or

title 21, CFR. FSIS’s listing will include:

a. Substances currently listed in title

9;

b. Substances currently listed for meat

or poultry uses in FDA food additive,

GRAS, or prior-sanction listings;

c. Approved color additives currently

listed in 21 CFR Parts 73, 74, and 82,

food additives listed in 21 CFR Parts

172–173 and 180, prior sanctioned

substances listed under part 181, GRAS

substances listed in 21 CFR 182 and

184, if permitted for general use in or on

foods (which includes meat and

poultry) in accordance with good

manufacturing practice, unless meat or

poultry uses of the substances are

otherwise precluded;

d. GRAS substances found by FSIS to

be suitable for specified meat and

poultry uses on the basis of information

and data submitted by petitioners to

FSIS. Factors affecting FSIS findings of

suitability include:

(1) Existing FDA GRAS listings,

which need not explicitly permit but

may not preclude the specific use in

meat or poultry products; and

(2) Concurrence of FSIS with the

petitioner and FDA acceptance of FSIS’s

determination.

e. FDA food additive, color additive,

GRAS, and prior-sanctioned substance

listings promulgated after this proposal

becomes final that provide for meat and

poultry uses.

Requests for use of substances not

authorized for use in meat and poultry

products must be made to FDA in the

form of a petition to amend FDA food

additive, color additive, or GRAS

affirmation regulations, as appropriate.

Specifically, this is required when the

substance: (1) is not expressly listed for

meat and poultry uses in title 9, CFR, or

in title 21, CFR, Parts 172–180; (2) is not

a GRAS substance listed in Part 182 or

184 of title 21 for general use in foods;

and (3) cannot be demonstrated to FSIS

to be GRAS for particular meat or

poultry uses.

The working relationship between the

two agencies, as set forth in the

memorandum of understanding (MOU)

between them, would ensure FDA and

FSIS collaboration on any petition that

includes a use in meat or poultry

products.

The Administrator of FSIS would

retain legal authority to prohibit or

restrict the use of specific substance(s)

in meat or poultry products by noticeand-comment rulemaking, but is not

expected to have to exercise that

authority on a regular basis because

FDA’s statutory authority, exercised in
67464 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

accord with the MOU, would provide a

basis for appropriate limitations on uses

in meat and poultry products.

The Proposed Rule

Under this proposal, FSIS would

discontinue duplicative rulemaking

activity regarding food additive and

GRAS substance uses in meat and

poultry products. FSIS would amend

the Federal meat and poultry products

inspection regulations in 9 CFR, Parts

310, 318, 319, and 381 to include

appropriate cross-references to title 21

listings of food additive and GRAS

substances permitted for use in meat

and poultry products.

Substances whose use is GRAS are

exempt from the premarket approval

requirements of the FFDCA and need

not be listed in title 21 of the Code of

Federal Regulations. For substances that

have not been listed by FDA as GRAS

in Parts 182 or 184 of title 21, FSIS will

continue to consider, in consultation

with FDA, a manufacturer’s basis for

claiming GRAS status and suitability for

use in meat, meat food, or poultry

products. Likewise, a manufacturer has

the option of seeking advice from FSIS

regarding the suitability for specific uses

in meat, meat food, or poultry products

for substances listed in title 21 only for

general use in foods, or for use in meat,

meat food, or poultry products

generally. FSIS’s responses and related

correspondence would be available to

the public, except that the formulation

and process data for proprietary

mixtures would be kept confidential.

Parties requesting such evaluations

would be advised to petition FDA when

the requested use is not permitted under

FDA’s regulations.

In keeping with this approach, FSIS

proposes that, as a matter of policy, all

substances currently listed by FDA as

GRAS in title 21 of the CFR, Parts 182

and 184, for use in food generally, with

no limitation other than good

manufacturing practice, be considered

by USDA to be GRAS for use in meat,

meat food product, and poultry product,

unless otherwise restricted for such use

by regulation in title 9 of the CFR. Uses

of substances may be restricted by FSIS

standards of identity or composition, or

in specific cases where the inspection

program determines that use may

adulterate the product.

Existing FSIS regulations in 9 CFR

318.7 and 381.147 listing substances for

various meat and poultry uses would

not be immediately affected. However,

FSIS plans to review its title 9 listings

within the next 3 to 5 years, and to

eliminate those that duplicate FDA’s

title 21 listings. FSIS and FDA believe

that the public will be better served by

having all permitted uses for food

additives and GRAS substances

consolidated in one place—listings in

title 21 of the CFR—and intend to work

toward that end. Because of resource

constraints, at the present time FDA

regulations in title 21 will be amended

to accommodate meat and poultry uses

only in response to a food additive,

color additive, or GRAS affirmation

petition.

All petitions for rulemaking to permit

new substances or new uses or use

levels of substances in foods—including

meat and poultry products—would be

sent to FDA. FDA would evaluate the

petitions in consultation with FSIS if

any prospective use of a food additive,

color additive, or GRAS substance

includes use in meat, meat food, or

poultry products.

The proposed revisions of 9 CFR

310.20 and 318.1 are intended only for

the purpose of including appropriate

references to substance listings in title

21, CFR. They would not change the

substantive requirements governing the

saving of livestock blood or the labeling

of containers. Similarly, the proposed

revision of 9 CFR 318.7(d)(2) is intended

only for the purpose of adding a

reference to title 21, CFR, and would not

change the prohibitions of and

restrictions on the substance uses

provided in that paragraph.

The proposed 9 CFR 318.7(a)(4),

318.7(a)(5) and 381.147(f)(2)(iv) are

intended to provide addresses for

inquiries concerning food or color

additive status of substances intended

for use in or in contact with meat or

poultry products. The proposed 9 CFR

318.79(a)(5) and 381.147(f)(2)(v) are

intended to provide addresses for

inquiries on the suitability for use in

meat or poultry products, of substances

not listed in the title 21 regulations.

These provisions are not intended as

requirements for a petitioning or

petition review process.

Appended to this proposed regulation

is a copy of the draft Memorandum of

Understanding between FDA and FSIS,

which would provide for the

administration of these provisions.

Executive Order 12866

This proposed rule has been reviewed

under Executive Order 12866 and found

to be significant, but not economically

significant, within the meaning of the

Executive Order (sec. 3(f)). It is

significant because it is a novel,

collaborative, inter-Agency approach to

streamlining regulation. It decreases

regulatory and paperwork burdens on

society by proposing an alternative to

the current Government process of

approving substances for use in foods.

This proposal would replace the

current Government processes for

approving substances and their uses in

meat and poultry products, involving

consecutive rulemakings by FDA and

FSIS, with a ‘‘one-stop’’ procedure

whereby sponsors of new food additive

or other substance uses in meat and

poultry products would have to petition

only the FDA. FDA would conduct any

required rulemaking on the matter in

consultation with FSIS. FDA’s rule

would then specify any uses or use

restrictions unique to meat or poultry

products, thereby permitting use of the

substance under the FMIA and PPIA.

This proposal embodies the regulatory

philosophy and principles of Section 1

of the Executive Order and was the

result of a review of existing regulations

consistent with the direction in section

5. It modifies existing FSIS regulations

concerning the approval of substances

to be added to meat, meat food, and

poultry products that have been found

to result in needless duplication of

effort and expenditures by Government

and the regulated industry. These

regulations necessitate sequential

rulemakings by FDA and FSIS to permit

a new substance or a new use of a

previously approved substance to be

used in meat, meat food, or poultry

products. The costs to industry and

Government of these rulemaking

procedures includes the costs to

industry arising from a several years’

delay in the introduction of new food

additives or new food products. These

costs create a disincentive for

technological innovation and new

product development. The existing

process, therefore, has a negative effect

on economic growth.

Benefit-Cost Assessment

The public benefits conferred by the

rulemaking include, principally, those

associated with the more timely

regulatory approval of substances added

to foods and the benefits of the

substances themselves. The benefits of

substances added to meat and poultry

products include the technical effects

on the characteristics of food products,

the uses of the substances in food

processing, and a greater variety of

foods in the marketplace. Public health

benefits can include the greater

availability of food through preservation

techniques and improved food safety

through, for example, antimicrobial

treatment of raw product and the use of

curing solutions in processed products.

The benefits conferred by the

availability of substances and their uses

would be marginally increased by this

rulemaking.
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67465

The public benefits of regulating food

additives generally would not change.

These include, principally, the

prevention of adulteration or

misbranding of food products.

Consumers are provided assurance that

the products they buy do not contain

substances whose use ought, for various

reasons, to be prohibited, or substances

that have been approved have not been

used improperly in foods. Such benefits

would not be affected by this proposed

rulemaking because FDA would

continue to conduct food safety reviews

of substances proposed for use in foods,

including—in consultation with FSIS—

meat and poultry products, and FSIS

would continue to exercise its in-plant

inspection and other regulatory

authorities to prevent the marketing of

adulterated or misbranded meat and

poultry products.

Therefore, elimination of the

duplicative FSIS rulemaking process

involved in approving substances for

use in meat and poultry products could

save the regulated industry about

$600,000 a year over and above the

savings the Government itself would

realize in administrative costs.

Other, albeit less calculable benefits

arise through the removal of a

disincentive to innovate. With the

potential expansion of uses of approved

food additives and other substances that

could result from the easing of the

current regulatory burden, new product

development and marketing could be

encouraged.

Executive Order 12778

This proposed rule has been reviewed

pursuant to Executive Order 12778,

Civil Justice Reform. This proposed rule

would provide for the use in meat and

poultry products of substances

approved by FDA and listed in 21 CFR

for such uses, and would eliminate the

requirement in the current 9 CFR

318.7(a) and 381.147(a) listing of such

uses in 9 CFR 318.7(c)(4) or

381.147(f)(4).

States and local jurisdictions are

preempted under the Federal Meat

Inspection Act (FMIA) and the Poultry

Products Inspection Act (PPIA) from

imposing any requirements with respect

to federally inspected premises and

facilities, and operations of such

establishments, that are in addition to,

or different than, those imposed under

the FMIA or PPIA. States and local

jurisdictions are also preempted under

the FMIA and PPIA from imposing any

marking, labeling, packaging, or

ingredient requirements on federally

inspected meat or poultry products that

are in addition to, or different than,

those imposed under the FMIA or the

PPIA. States and local jurisdictions may,

however, exercise concurrent

jurisdiction over meat and poultry

products that are outside official

establishments for the purpose of

preventing the distribution of meat 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. States

and local jurisdictions may also make

requirements or take other actions that

are consistent with the FMIA and PPIA,

with respect to any other matters

regulated under the FMIA and PPIA.

Under the FMIA and the PPIA, States

that maintain meat and poultry

inspection programs must impose

requirements on State-inspected

products and establishments that are at

least equal to those required under the

FMIA or PPIA. These States may,

however, impose more stringent

requirements on such State-inspected

products and establishments.

In the event of its adoption, no

retroactive effect would be given to this

proposed rule, and applicable

administrative procedures must be

exhausted before any judicial challenge

to the application of these provisions.

Those administrative procedures are set

forth in 9 CFR 306.5, 318.21(h), 381.35,

and 381.153(h).

Effect on Small Entities

The Administrator, FSIS, has

determined that the proposed

amendments would not have a

significant economic impact on a

substantial number of small entities.

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.

FSIS now may approve for use in

meat or poultry products only those

substances that have been previously

reviewed for safety and approved for

such use by FDA. Under the proposed

amendments, separate petitions to FSIS

would no longer have to be submitted.

FSIS would permit substances to be

used in products under its jurisdiction

on the basis of FDA’s title 21 regulations

permitting such uses. 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 by FDA as GRAS or

otherwise listed in 21 CFR part 182 or

184, or a substance listed by FDA for

general food use, manufacturers would

have the option of requesting that FSIS

evaluate the manufacturer’s assertion of

the GRAS status of the substance and its

suitability for a specified use in meat

and poultry products.)

FSIS is currently receiving about six

petitions per year for the approval of

substances for use in meat and poultry

products. Most of these petitions are

from large commercial entities.

Although the reduction in costs from

the proposed rule would be significant,

but unknown, for prospective

petitioners, the number of such entities

is not substantial. Therefore, the

proposed amendments would not have

a significant effect on a substantial

number of small entities.

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.

Paperwork Reduction Act

FSIS has determined that the

proposed rulemaking would entail no

new information collection from the

regulated industry or other private

entities. Rather, the effect of the

rulemaking would be to substantially

reduce the information collection from

private sources concerning proposed

uses of substances in meat or poultry

products. Persons seeking Federal

Government approval of substances for

use in meat or poultry foods would only

have to petition FDA, rather than both

FDA and FSIS, as they now do. Thus,

a current, duplicative information

collection requirement would be

eliminated.

List of Subjects

9 CFR Part 310

Animal diseases, Meat inspection.

9 CFR Part 318

Food additives, Meat inspection.

9 CFR Part 319

Food grades and standards, Meat

inspection.

9 CFR Part 381

Food grades and standards, Meat

inspection, Poultry and poultry

products.

For the reasons set forth in the

preamble, FSIS proposes to amend Parts

310, 318, 319, and 381 of title 9, Code

of Federal Regulations, as follows:

PART 310—POST-MORTEM

INSPECTION

1. The authority citation for Part 310

would be revised to read as follows:
67466 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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

2.53.

2. Section 310.20 would be revised to

read as follows:

§ 310.20 Saving of blood from livestock as

an edible product.

Blood may be saved for edible

purposes at official establishments

provided it is derived from livestock,

the carcasses of which are inspected and

passed, and the blood is collected,

defibrinated, and handled in a manner

so as not to render it adulterated under

the Federal Meat Inspection Act and

regulations issued pursuant thereto. The

defibrination of blood intended for

human food purposes shall not be done

with the hands. Anticoagulants

specified in title 21 of the Code of

Federal Regulations or in this

subchapter may be used in lieu of

defibrination.

PART 318—ENTRY INTO OFFICIAL

ESTABLISHMENTS; REINSPECTION

AND PREPARATION OF PRODUCTS

3. The authority citation for Part 318

would be revised to read as follows:

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

U.S.C. 601–695; 7 CFR 2.18, 2.53.

4. Section 318.1(d) would be revised

to read as follows:

§ 318.1 Products and other articles

entering official establishments.

* * * * *

(d) Containers of preparations which

enter any official establishment for use

in hog scalding water or in denuding of

tripe shall bear labels showing the

chemical names of the preparations. In

the case of any preparation containing

any of the chemicals which are

specifically limited by title 21 of the

Code of Federal Regulations, Parts 73,

74, 81, 172, 173, 179, 182, or 184, or by

a regulation in this subchapter, as to

amount permitted to be used, the labels

on the containers must also show the

percentage of each such chemical in the

preparation and must provide dilution

directions which prescribe the

maximum allowable use concentration

of the preparations.

* * * * *

5. Section 318.7 would be amended

by revising the heading, paragraph (a)

and paragraph (d)(2) to read as follows:

§ 318.7 Restrictions on the use of

substances in meat and meat food

products.

(a) (1) Substances permitted for use in

meat and meat food product in title 21,

CFR, shall be permitted for such use

under this subchapter, subject to

declaration requirements in Parts 316

and 317 of this subchapter, unless

precluded from such use or further

restricted in Parts 318 or 319 of this

subchapter, or by the Administrator in

specific cases.

(2) (i) No substance may be used in

the preparation of any product, for any

purpose, unless its use is authorized

under title 21, CFR, as a direct food

additive (Part 172), a secondary direct

food additive (Part 173), source of

radiation (Part 179), an interim-listed

direct food additive (Part 180), a priorsanctioned substance (Part 181), or

listed as a Generally Recognized As Safe

(GRAS) substance or (Part 182 or 184),

or by a regulation in this subchapter.

(ii) No substance the intended use of

which is to impart color in any product

shall be used unless such use is

authorized under title 21, CFR, as a

color additive (Parts 73, 74, and 81), or

by a regulation in this subchapter.

(3) Petitions to amend title 21

regulations to provide for meat or meat

food product uses of substances used in

the preparation of product, or

substances used to impart color to

product, shall be filed with the Food

and Drug Administration, in accordance

with the provisions of title 21 CFR part

71 or 171, as appropriate.

(4) Inquiries concerning the regulatory

status under the Federal Food, Drug,

and Cosmetic Act of any articles

intended for use as components of, or in

contact with, meat or meat food

product, should be addressed to the

Department of Health and Human

Services, Food and Drug

Administration, Center for Food Safety

and Applied Nutrition, 200 C Street,

SW., Washington, DC 20204.

(5) Inquiries concerning the suitability

for use in specific meat or meat food

products of substances that are not

affirmed by FDA as GRAS or otherwise

listed in 21 CFR part 182 or part 184,

or of substances listed in title 21

regulations for general use in foods, or

for use in meat or meat food products

generally, including mixtures of such

substances, should be addressed in

writing to the Department of

Agriculture, Food Safety and Inspection

Service, Product Assessment Division,

USDA, FSIS, RP, West End Court

Building, Washington, DC 20250–3700.

Copies of such correspondence, except

for information on proprietary mixtures,

will be placed in the public record. A

list of proprietary substances and nonfood compounds determined suitable

for specified uses also may be obtained

from the Product Assessment Division,

at the same address.

* * * * *

(d) * * *

(2) Sorbic acid, calcium sorbate,

sodium sorbate, and other salts of sorbic

acid shall not be used in cooked sausage

or any other product; sulfurous acid and

salts of sulfurous acid shall not be used

in or on any product, and niacin or

nicotinamide shall not be used in or on

fresh product, except that potassium

sorbate, propylparaben (propyl phydroxybenzoate), calcium propionate,

sodium propionate, benzoic acid, and

sodium benzoate may be used in or on

any product only as provided in 21 CFR

or by a regulation in this subchapter.

* * * * *

PART 319—DEFINITIONS AND

STANDARDS OF IDENTITY OR

COMPOSITION

6. The authority citation for 9 CFR

Part 319 would be revised to read as

follows:

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

U.S.C. 601–695; 7 CFR 2.18, 2.53.

§ 319.100 [Amended]

7. Section 319.100 would be amended

by removing ‘‘§ 318.7(c) (1) and (4) of

this subchapter’’ in the first sentence

and replacing it with ‘‘a regulation

permitting that use in this subchapter or

in 21 CFR Chapter I, Subchapter B.’’

§ 319.106 [Amended]

8. Section 319.106 would be amended

by removing ‘‘in accordance with

318.7(c)(4) of this subchapter’’ in

paragraph (d)(2) and replacing it with ‘‘a

regulation permitting that use in this

subchapter or in 21 CFR Chapter I,

Subchapter B.’’

§ 319.140 [Amended]

9. Section 319.140 would be amended

by removing ‘‘§ 318.7(c)(4) of this

subchapter’’ in the second and third

sentences and replacing it with ‘‘a

regulation permitting that use in this

subchapter or in 21 CFR Chapter I,

Subchapter B.’’

§ 319.145 [Amended]

10. Section 319.145 would be

amended by removing ‘‘in the chart

following § 318.7(c)(4),’’ in paragraph

(a)(4) and replacing it with ‘‘in a

regulation permitting that use in this

subchapter or in 21 CFR Chapter I,

Subchapter B’’ and in paragraph (b)(6)

by removing ‘‘the chart of substances in

§ 318.7(c)(4) of this subchapter.’’ and

replacing it with ‘‘a regulation

permitting that use in this subchapter or

in 21 CFR Chapter I, Subchapter B.’’

§ 319.180 [Amended]

11. Section 319.180 would be

amended by removing ‘‘§ 318.7(c)(4) of
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67467

this chapter,’’ in the first sentence of

paragraph (a) and the first sentence of

paragraph (b) and replacing it with ‘‘a

regulation permitting that use in this

subchapter or in 21 CFR Chapter I,

Subchapter B.’’ and by removing

‘‘§ 318.7(c)(4) of this subchapter.’’ in the

first sentence of paragraph (e) and

replacing it with ‘‘a regulation

permitting that use in this subchapter or

in 21 CFR Chapter I, Subchapter B.’’

§ 319.303 [Amended]

12. Section 319.303 would be

amended by removing ‘‘§ 318.7(c)(4) of

this subchapter’’ from the second

sentence of paragraph (a)(3) and

replacing it with ‘‘a regulation

permitting that use in this subchapter or

in 21 CFR Chapter I, Subchapter B.’’

§ 319.700 [Amended]

13. Section 319.700 would be

amended by removing ‘‘§ 318.7(c)(4) of

this chapter’’ in paragraph (a)(4),

paragraph (a)(5), and paragraph (a)(6),

and replacing it with ‘‘a regulation

permitting that use in this subchapter or

in 21 CFR Chapter I, Subchapter B’’; by

removing ‘‘§ 318.7(c)(4) of this chapter,’’

from the first sentence of paragraph

(a)(7) and replacing it with ‘‘21 CFR

Parts 73, 74, or 82,’’; and removing

‘‘§ 318.7(c)(4) of this chapter,’’ from the

first sentence of paragraph (a)(9) and the

first sentence of paragraph (a)(10) and

replacing it with ‘‘a regulation

permitting that use in 21 CFR Chapter

I, Subchapter B.’’

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

14. The authority citation for 9 CFR

Part 381 would be revised to read as

follows:

Authority: 21 U.S.C. 450, 21 U.S.C. 451–

470, 7 CFR 2.18, 2.53.

15. Section 381.147 would be

amended by revising paragraph (f) to

read as follows:

§ 381.147 Restrictions on the use of

substances in poultry products.

* * * * *

(f)(1) Substances permitted for use in

poultry product in 21 CFR chapter I

shall be permitted for such use under

this subchapter, subject to declaration

requirements in Subparts M and N of

this subchapter, unless precluded from

such use or further restricted in

Subparts O and P of this subchapter, or

by the Administrator in specific cases.

(2)(i) No substance may be used in the

preparation of any product, for any

purpose, unless its use is permitted

under 21 CFR chapter I as a direct food

additive (Part 172), a secondary direct

food additive (Part 173), a source of

radiation (Part 179), an interim-listed

direct food additive (Part 180), or is a

prior-sanctioned substance (Part 181), or

is a GRAS substance listed in Part 182

or Part 184, or is otherwise permitted by

a regulation in this subchapter.

(ii) No substance the intended use of

which is to impart color in any product

shall be used unless such use is

authorized under 21 CFR chapter I as a

color additive (Parts 73, 74, and 82), or

by a regulation in this subchapter.

(iii) Petitions to amend title 21

regulations to provide for poultry

product uses of substances used in the

preparation of product, or substances

used to impart color to product, should

be sent to FDA, in accordance with the

provisions of 21 CFR part 71 or 171, as

appropriate.

(iv) Inquiries concerning the food or

color additive status under the Federal

Food, Drug, and Cosmetic Act of any

articles intended for use as components

of, or in contact with, poultry product,

should be addressed to the Department

of Health and Human Services, Food

and Drug Administration, Center for

Food Safety and Applied Nutrition, 200

C St., SW, Washington, DC 20204.

(v) Inquiries concerning the suitability

for use in specific poultry products of

substances that are not affirmed by FDA

as GRAS or otherwise listed in 21 CFR

part 182 or part 184, or of substances

listed in title 21 regulations for general

use in foods, or for use in poultry

products generally, including mixtures

of such substances, should be addressed

in writing to the Department of

Agriculture, Food Safety and Inspection

Service, Product Assessment Division,

USDA, FSIS, RP, West End Court

Building, Washington DC 20250. Copies

of such correspondence will be placed

in the public record, except for

correspondence concerning proprietary

mixtures. A list of proprietary

substances and non-food compounds

determined suitable for specified uses

may be obtained from the Product

Assessment Division, at the same

address.

* * * * *

§ 381.120 [Amended]

16. Section 381.120 would be

amended by removing ‘‘§ 381.147’’ from

the fourth sentence and from the sixth

sentence and replacing it with ‘‘a

regulation permitting that use in this

subchapter or in 21 CFR Chapter I,

Subchapter B.’’

§ 381.132 [Amended]

17. Section 381.132 would be

amended by removing ‘‘§ 381.147’’ from

paragraph (c)(3)(iii)(D) and replacing it

with ‘‘a regulation permitting that use in

this subchapter or in 21 CFR Chapter I,

Subchapter B.’’

§ 381.171 [Amended]

18. Section 381.171 would be

amended by removing ‘‘§ 381.147 of this

part’’ from the first and second

sentences of paragraph (b) and replacing

it with ‘‘a regulation permitting that use

in this subchapter or in 21 CFR Chapter

I, Subchapter B.’’

Done, at Washington, DC, on: December 21,

1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

Appendix

Note: This appendix will not appear in the

Code of Federal Regulations.

Memorandum of Understanding (MOU)

Between the Food Safety and Inspection

Service (FSIS), U.S. Department of

Agriculture (USDA) and the U.S. Food And

Drug Administration (FDA), U.S. Department

of Health and Human Services (USDHHS)

Regarding the Approval of Food Additives,

Color Additives, and other Substances Used

in Meat and Poultry Products

I. Purpose

This agreement establishes the working

relationship and procedures to be followed

by FSIS and FDA in responding to requests

for the approval of the use of substances

subject to regulation by the FDA and

intended for use in meat and meat food

products (hereinafter known collectively as

meat products) and poultry products

regulated by FSIS.

II. Background

The Federal Meat Inspection Act (FMIA)

and the Poultry Products Inspection Act

(PPIA), and the Federal Food, Drug, and

Cosmetic Act (FFDCA) provide FSIS and

FDA, respectively, with the authority to

determine the safety, wholesomeness, and

accurate labeling of foods. The Food

Additives Amendment of 1958 to the FFDCA

(21 U.S.C. 348) gives FDA the authority to

determine the safety of food additives prior

to their marketing. The Color Additives

Amendment of 1960 (21 U.S.C. 379e) grants

FDA premarket review authority comparable

with these amendments to the FFDCA for

color additives intended for use in foods,

drugs, cosmetics, and medical devices. FDA

has assumed primary authority over the

approval of the use of food additives and

color additives used in foods. FSIS has

retained authority under the FMIA and PPIA

to further regulate uses of such FDAapproved substances in meat and poultry

products, respectively, as needed, to ensure

inspected products are not adulterated or

misbranded.

The process for documenting approved

uses of substances intended for use in meat

and poultry products has required that such

ingredients first be reviewed and approved

by FDA (in the form of an FDA regulation),

and then subsequently be reviewed and

incorporated into FSIS regulations. FDA’s
67468 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

approval of food additives and color

additives is based on reviews of data and

other information establishing the safety of

the substance for its intended use in food. To

approve a food additive, the Agency must

also determine that the food additive

achieves its intended technical effect; to

approve a color additive, the Agency must

also determine that the color additive is

suitable for its indended use. However, these

criteria are not sufficient to establish the

suitability of such additives for use in meat

or poultry products. Subsequent FSIS

approval is based primarily on review of data

regarding the efficacy and suitability of the

substance for its intended use in meat and

poultry products that FSIS regulates under

the FMIA and PPIA. FSIS requires data that

support the lowest level of the subject

substance(s) needed to achieve the intended

effect. FSIS is charged with ensuring the

safety of inspected products. However, with

respect to the safety of food and color

additives that may be used in those products,

FSIS defers to FDA determinations under the

FFDCA.

In light of the foregoing regulatory context,

FDA and USDA/FSIS have concluded:

A. The duplicative, sequential approval

process for substances intended for use in

meat and poultry products is unnecessarily

cumbersome, time-consuming, and costly to

all parties involved, and has fostered

confusion over the relationship between FDA

and FSIS regulations.

B. Consolidation and harmonization of the

Agencies’ approvals in this regard will result

in fewer and more consistent Federal

approval regulations for substances used in

food, and will provide simpler and less

expensive procedures for petitioners seeking

approval of substances under the FMIA and

PPIA.

C. This Memorandum of Understanding

should clarify the Agencies’ working

relationship and, in particular, provide

procedures whereby:

1. In situations where FSIS’s Title 9 and

FDA’s Title 21 regulations do not specifically

address the intended use of a particular

substance for meat or poultry products, any

interested party may request that FSIS

evaluate the status of such use. FSIS will

conduct a review and determine whether the

use is acceptable in meat or poultry products,

including whether the use is approved under

the FFDCA. Under the terms of this MOU,

FSIS would seek FDA’s concurrence with

FSIS’s review and conclusions. If FDA does

not concur that the use is approved under the

FFDCA, the petitioner would be required to

submit a food additive or color additive

petition to FDA requesting that FDA’s

regulations be amended to accommodate the

requested use.

2. In situations in which FDA receives a

petition for the use of a substances or a use

of a substance that is not approved under the

FFDCA, a petitioner shall prepare and submit

a food additive petition or a color additive

petition only to FDA. FDA will consult with

FSIS regarding petitions for meat and poultry

use and, under the terms of this MOU, FSIS

concurrence would be required for the

approval of the use of substances intended

for use in meat and poultry and that are

codified in Title 21 of the Code of Federal

Regulations.

D. This agreement and these procedures

are not intended to erode the existing

authority of FDA or of FSIS to provide

guidance on the status and conditions of use

of substances intended for use in meat and

poultry.

III. Scope

This agreement between FSIS and FDA

concerns procedures for Federal approval of

food additives, color additives, and other

food ingredients that are regulated by FDA

under the FFDCA and may be used in meat

and poultry products that are subject to the

FMIA and the PPIA. This agreement further

provides for the review and classification, as

needed, of substances asserted to be exempt

from regulation under the FFDCA because

they are generally recognized as safe, or are

covered by a prior sanction.

IV. Collaborative FSIS—FDA Approvals of

Substances Intended for Use in Meat and

Poultry Products

A. Petitions for FDA approval of

Substances Intended for Use in Meat and

Poultry Products.

Relevant portions of petitions submitted to

FDA for the use of new substances or new

uses of approved substances will be shared

with FSIS by FDA when the proposed use

specifically includes use in meat and poultry

products. FSIS will provide advice to FDA,

in writing, on any criteria, restrictions,

conditions of use, or prohibitions FSIS

believes necessary concerning use of the

substance in products subject to the FMIA

and the PPIA.

B. Requests for FSIS Determination on

Acceptability of Substance Uses in Meat and

Poultry Products.

FSIS routinely provides advice and

counsel to individuals and issues guidance

on the status and conditions of use of

substances in products under its regulatory

purview. Requests for a determination of the

acceptability of substances may result in the

need for rulemaking when: (1) FSIS

standards of identity and composition

preclude the use of a substance; or (2) there

is concern about the suitability of a substance

for the intended use because the substance

has never been used in meat or poultry

before, or the applications of the substance

are new, e.g., a new meat, meat food, or

poultry product category.

Requests for a determination of

acceptability of new substances and new uses

of substances in meat and poultry products

are currently submitted by the requester (e.g.,

an ingredient manufacturer, meat or poultry

processor, or trade group) to FSIS. FSIS will

continue to require that a request for an

acceptability determination for the use of a

new substance in meat or poultry or for the

new use of an approved substance be

supported by information and technical data

that establish that: (1) the use of the

substance will not render the product in

which it is used adulterated or misbranded

and (2) the proposed use of the substance is

at the lowest level necessary to accomplish

the intended technical effect(s) in each

category of the product in which the

substance will be used.

Under the terms of this memorandum,

when FSIS receives a request for a

determination on whether the use of a

substance in meat or poultry will be

permitted, FSIS will evaluate the request and

render a determination of acceptability (i.e.,

safety and suitability). In instances where the

use of the requested substance is not

explicitly authorized by FDA regulations,

FSIS will consult with FDA concerning

FSIS’s evaluation of the regulatory status of

the food ingredient. If FDA has no objection

to FSIS’s determination, FSIS, through its

Product Assessment Division (PAD), will

amend Agency directives and other guidance

materials to reflect the approved use. If FDA

objects to FSIS’s determination, the request

will be denied and the requester will be

advised to petition FDA to amend FDA’s

regulations to permit the use of the substance

at issue.

V. The Agreement

A. FSIS will:

1. Receive requests for evaluation of the

acceptability of new substances and new uses

of approved substances for use in meat and

poultry products subject to the FMIA and

PPIA.

2. Through the activities of the PAD,

review all data submitted in support of

requests for ingredient use and, in

consultation with FDA, make acceptability

determinations on use in meat and poultry

products. FSIS’s Regulatory Programs will

seek written concurrence from FDA’s Center

for Food Safety and Applied Nutrition on

FSIS acceptability determinations before use

is granted and the substance is listed in FSIS

directives or other guidance material. If use

of a substance is not found to be acceptable,

the requester will be advised to submit a

petition to FDA to approve the use of

substance in meat or poultry products.

3. Forward to FDA all food and color

additive petitions and petitions for

affirmation of GRAS status for use of such

substances in meat or poultry products.

4. Respond in a timely manner to inquiries

from FDA regarding petitions or requests for

approval of the use of food additives, color

additives, or GRAS substances or new uses

of such substances in meat and poultry

products regulated under the FMIA and

PPIA.

5. Continue to provide advice and counsel

on, and clarification of, the acceptability and

uses permitted under the FMIA and PPIA of

substances used in meat and poultry

products.

B. FDA will:

1. Receive petitions for approval of

substances intended for use in foods,

including meat or poultry products regulated

under the FMIA and PPIA.

2. Advise interested persons if a petition is

needed to amend FDA regulations to

accommodate the requested uses.

3. Advise FSIS of any new substance

listings in Title 21 concerning use

restrictions or conditions of use, and

common or usual names of substances

intended for use, in meat or poultry products.

4. Provide FSIS, PAD, with copies of

relevant information from petitions and

accompanying data submitted by petitioners
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.