[From Federal Register, Aug. 8, 1967]

PROPOSED RULE MAKING

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

FOOD AND DRUG ADMINISTRATION

[21 CFR Part 121]

FOOD ADDITIVES

PROCEDURAL REGULATIONS

The Commissioner of Food and Drugs proposes that the procedural food additive regulations be revised as set forth below to obtain improvement in the qual ity and organization of food additive petitions submitted and to expedite their scientific review by the Food and Drug Administration. The need for such revi sion is based on the following:

A. Almost half of the food additive petitions as originally submitted to the Food and Drug Administration have been incomplete or have not adequately sup ported the regulation requested and, therefore, have required subsequent sup plementation, amendment, withdrawal, or denial.

B. Scientific review of deficient and poorly organized petition is an unneces sary burden that wastes the time and efforts of both Administration and industry scientists.

Therefore, pursuant to the provisions of the Federal Food, Drug, and Cosmetic Act (secs. 409, 701(a), 52 Stat. 1055, 72 Stat. 1786; 21 U.S.C. 348, 371(a)) and under the authority delegated to the Commissioner by the Secretary of Health. Education, and Welfare (21 CFR 2.120), it is proposed that Part 121 be amended by revising §§ 121.7, 121.9, and 121.51 and by adding § 121.50 as follows: § 121.7 Food additives for use in feed and drinking water of animals and food additives that are also new drugs, certifiable antibiotic drugs, and/or pesti cides.

(a) (1) A substance that is a new drug within the meaning of section 201(p) of the act or an antibiotic drug subject to the certification requirements of sec tions 502 (1) and 507 of the act may also be a food additive within the meaning of section 201 (s) of the act because the substance is to be used in the feed of an animal or because its intended use in or on the animal results or may reasonably be expected to result directly or indirectly in it or its conversion product (8) becoming a component of or otherwise affecting the characteristics of a food derived from the animal.

(2) An application for a new drug or an antibiotic drug which substance is also a food additive shall be submitted in the form prescribed by § 130.4 of this chapter (Form FD 356V) and processed in accordance with Parts 130 (new drug) or 146 (antibiotic drug) of this chapter, and the food additive aspects of such applications shall be processed simultaneously.

(3) An application for a new drug or an antibiotic drug which substance is also a food additive shall include a practical, chemical assay method of enforce ment of any tolerance provided and, if edible products of food-producing animals are involved, data establishing the residues of the substance or its metabolites in such edible products.

(b) Petitions for food additives that are nondrug substances for use in the drinking water or feed of animals shall be submitted in the form described in § 121.50 and shall be processed in accordance with the procedures prescribed in

this Part 121.

(c) Any pesticide chemical added to processed feed for animals for the purpose of affecting such animals will be considered a food additive and new drug subject to approval under sections 409 and 505 of the act. Petitions for such pesticide chemicals shall be submitted and processed in accordance with paragraph (a)(2)

of this section.

(d) A new-drug application will not be approved for a use that results in the substance becoming a food additive until a regulation therefor is established under section 409 of the act. A food additive regulation under section 409 of the act will not be established if the additive results from the use of a new drug for which a new-drug application cannot be approved. The new-drug application and the establishment of a regulation regarding the food additive aspects will be acted on simultaneously.

(e) Applications for use of any drug substance in feed or for a drug or antibiotic substance intended to be administered to a food-producing animal shall be submitted to the Bureau of Veterinary Medicine of the Food and Drug Administration for evaluation.

§ 121.9 Food additive master files.

(a) Any person submitting or intending to submit a food additive petition may submit confidential information or information entitled to protection as a trade secret in the form of a "food additive master file." Such master file will be assigned a number and will be retained as available material that may be incorporated in any food additive petition upon request from the person submitting such file.

(b) The material in the master file shall be arranged and indexed by page numbers as if it were a portion of a petition so that specific material may be precisely referenced in any separate subsequent petition.

(c) The analytical methods and a summary of the toxicological basis on which a food additive regulation is based are not considered confidential or entitled to protection as trade secrets.

§ 121.50 Content and form of food additive petitions.

(a) Petitions to be filed under the provisions of section 409 (b) of the act shall be submitted in triplicate, in the form described in paragraphs (c) and (d) of this section. Any material submitted in a foreign language shall be accompanied by an accurate English translation. Any published information used in support of the petition shall be submitted in reprint form. The petition must be signed by the petitioner or by an authorized attorney, agent, or official. If the petitioner or such authorized representative does not reside or have a place of business within the United States, the petition must also furnish the name and post office address of and must be countersigned by an authorized attorney, agent, or official residing or maintaining a place of business within the United States. All original, unpublished scientific studies supplied in the petition shall include identification of the scientists who did the work and their pertinent qualifications. The omission of any material required by this section shall be noted and the reasons therefor stated.

(b) Information previously submitted by the petitioner to the Food and Drug Administration may be incorporated in subsequent submissions provided specific reference to such information is made by giving the type of submission and the volume, page, and date submitted, and provided that the submission is in a food additive master file kept current by the petitioner, or is in another form of submission not over 10 years old. Confidential material entitled to protection as a trade secret, such as method of manufacture or process information, in food additive petitions or food additive master files furnished by a person other than the petitioner may also be incorporated provided use of such information is authorized in a written statement signed by the person who submitted the information or his successor in interest.

(c) Petitions shall be assembled in the manner prescribed in paragraph (e) of this section and submitted in a form suitable for binding, with all text double spaced on 8 x 102-inch pages with a left-hand margin of approximately 12 inches and a right-hand margin of approximately 1 inch. The left-hand margin shall be punched for a standard two-hole fastener (24-inch span) vertically centered therein. Each section shall have a section divider with index tab thereon bearing the section heading. The pages in each section shall be identified with the letter designation for the section and consecutively numbered.

(d) Petitions shall be transmitted by a cover letter in triplicate in the follow. ing form:

Petitions Control Branch,

Food and Drug Administration,

Department of Health, Education, and Welfare,

Washington, D.C. 20204.

GENTLEMEN: The undersigned,

submits this

petition pursuant to section 409 (b)(1) of the Federal Food, Drug, and Cosmetic Act with respect to

(Name of food additive and proposed use)

The petition is attached and is submitted in the form described in § 121.50 (21 CFR 121.50) of the food additive regulations.

Sincerely yours,

Petitioner

By

(Indicate authority)
Date

(e) The food additive petition shall contain:

I. INTRODUCTION (ON SECTION TAB)

A. A detailed table of contents listing all items contained in the petition and the page numbers where located.

B. A well-organized and coherent general summary of the data in the petition and the petitioner's conclusions, presenting a sound basis for the regulation requested and including the following information with references to the pages on which the detailed data in the petition may be found.

1. Identity and composition. The name of the additive and the specifications proposed to assure that the substance is of appropriate grade for the intended use and that it is of reproducible composition.

2. Use. The purpose which the additive is to serve including an estimate of the maximum as well as the average quantity of the food additive to be expected in the total daily diet of the consumer and including the basis on which the esti

mate is made.

3. Technical effect. Highlights of the data that have been developed to estab lish that the additive accomplishes the intended technical effect and that the amount sought to be used is no higher than that reasonably necessary to accomplish such intended technical effect.

4. Methods. Highlights of the data that establish that the analytical methods provided are practicable regulatory ones adequate to enforce the limitations considered necessary on the use of the additive.

5. Toxicology. Highlights of the studies provided to establish the safety of the proposed uses of the additive with an explanation of how the petitioner concludes that the proposed uses are safe, including summaries of any unfavorable results as well as the favorable. The highlights shall include the no-effect levels found in the several species of test animals and the maximum safe level in the diet of the consumer. The margins of safety between the no-effect level in the most sensitive species of test animals and the average level as well as the maximum level likely to occur in the total diet of the consumer should be stated, taking into consideration previously approved food additive uses for the substance and any comparable substances. Also included shall be a summary of the published lit erature dealing with the safety of the compound. If safety depends upon virtual lack of migration, the rationale shall be explained briefly.

II. BODY OF THE PETITION

A. Identity (on section tab).

This section shall identify the additive and the general use or combination of uses for which it is intended (i.e, direct additive, indirect additive, pesticide for food additive application, or radiation) and shall provide the following informa tion, as applicable:

1. Direct additive-a. Nomenclature and formulas. i. Common or usual name: Unless the name is being proposed as the common or usual name, cite references to compendia that recognize the name as common or usual.