Substances Approved for Use in the Preparation of Meat and Poultry Products

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 USDA-inspected 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

[[Page 67460]]

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, 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 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

[[Page 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

[[Page 67462]]

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-and-comment 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-and-

comment 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.)

[[Page 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-and-comment 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 notice-and-comment rulemaking, but is not expected to have

to exercise that authority on a regular basis because FDA's statutory

authority, exercised in

[[Page 67464]]

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.

[[Page 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:

[[Page 67466]]

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

2. Section 310.20 would be revised to read as follows:

Sec. 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:

Sec. 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:

Sec. 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 prior-sanctioned 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 non-food 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 p-hydroxybenzoate), 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.

Sec. 319.100 [Amended]

7. Section 319.100 would be amended by removing ``Sec. 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.''

Sec. 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.''

Sec. 319.140 [Amended]

9. Section 319.140 would be amended by removing ``Sec. 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.''

Sec. 319.145 [Amended]

10. Section 319.145 would be amended by removing ``in the chart

following Sec. 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 Sec. 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.''

Sec. 319.180 [Amended]

11. Section 319.180 would be amended by removing ``Sec. 318.7(c)(4)

of

[[Page 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 ``Sec. 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.''

Sec. 319.303 [Amended]

12. Section 319.303 would be amended by removing ``Sec. 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.''

Sec. 319.700 [Amended]

13. Section 319.700 would be amended by removing ``Sec. 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

``Sec. 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 ``Sec. 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:

Sec. 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.

* * * * *

Sec. 381.120 [Amended]

16. Section 381.120 would be amended by removing ``Sec. 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.''

Sec. 381.132 [Amended]

17. Section 381.132 would be amended by removing ``Sec. 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.''

Sec. 381.171 [Amended]

18. Section 381.171 would be amended by removing ``Sec. 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 FDA-approved

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

[[Page 67468]]

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

[[Page 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:

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Director, CFSAN, FDA

----------------------------------------------------------------------

Date

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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]

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