§ 121.72

Adoption of regulation on initiative of Commissioner.

(a) The Commissioner upon his own initiative may propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used. Notice of such proposal shall be published in the FEDERAL REGISTER and shall state the reasons for the proposal.

(b) Action upon & proposal made by the Commissioner shall, after publication of the notice, proceed as provided in § 121.51 and section 409 of the act.

§ 121.73 Judicial review.

The Secretary of Health, Education, and Welfare hereby designates the Assistant General Counsel for Food and Drugs of the Department of Health, Education, and Welfare as the officer upon whom copy of petition for judicial review shall be served. Such officer shall be responsible for filing in the court a transcript of proceedings and the record on which the order of the Secretary of Health, Education, and Welfare is based. The transcript and record shall be certified by the Secretary.

§ 121.74 Procedure for amending and repealing tolerances or exemptions from tolerances.

(a) The Commissioner or any interested person may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exemption for such additive. Such a proposal by an interested person shall be in writing. If such proposal by an interested person furnishes reasonable grounds therefor, the Commissioner will publish a notice announcing the proposal. Proposals initiated by the Commissioner will likewise be published. Following such publica

tion, the proceedings shall be the same as prescribed by section 409 of the act and the regulations in this part for the promulgation of a regulation.

(b) "Reasonable grounds" shall include an explanation showing wherein the person has a substantial interest in such regulation and an assertion of facts (supported by data if available) showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data should be furnished in the form specified in § 121.51 for submitting petitions.

§ 121.75 Exemption for investigational

use.

A food additive, or a food containing such an additive intended for investigational use by qualified experts, shall be exempt from the requirements of section 409 of the act: Provided, That the food additive or the food containing the additive bears a label which states prominently "Caution-Contains new food additive-For investigational use only. Not to be used for human food or food for other than laboratory animals."

§ 121.84 Further extension of effective date of statute for certain specified food additives.

(a) All extensions of the effective date of section 409 of the act (as amended by Public Law 88-625) are limited to those additives listed in § 121.90 for direct additives and § 121.91 for indirect additives. Public Law 88-625 provides that a food additive previously granted an extension to June 30, 1964, may be further extended but not beyond December 31, 1965, provided that the applicable findings required by the statute can be made. Extensions may be made beyond June 30, 1964, on food additives meeting the requirements of this section, provided that the following data are submitted:

(1) The specific name (not trade name) or chemical designation of the substance involved, the specific use or uses for which an extension is desired, and the amount and purpose of the substance involved in each such usage.

(2) A statement detailing actions taken and dates thereof to determine the applicability of the food additives

amendment to such use or uses or to develop the scientific data necessary for action, together with the results of such actions to date.

(3) A statement outlining additional work in progress, detailing its nature, when started, by whom it is being conducted, and the results to date.

(4) A statement of the amount of time for which further extension is needed. (Include only the time expected to be needed to determine that the substance is not a food additive or to submit a petition for an appropriate regulation to the Food and Drug Administration. Do not include any estimated time for processing a petition by the Food and Drug Administration.)

(b) Requests for extension may be submitted by any interested person who has the necessary facts, whether or not he obtained or requested the extension previously.

(c) Current extensions will be limited to a time period not exceeding June 30, 1965, but these may be reextended to December 31, 1965, upon request made prior to June 30, 1965, if a progress report as of June 30, 1965, accompanies the request, and if all relevant facts justify such reextension.

(d) If any of the information described in this section is included in petitions for food additive regulations or applications for extensions already submitted to the Commissioner, this information may be incorporated by reference. (e) Decisions on requests for further extensions, including the amount of time

Product

for which each extension is granted, will be published in the FEDERAL REGISTER. All requests for extensions should be addressed to the Petitions Control Branch, Food and Drug Administration, Washington, D.C., 20204.

§ 121.89 Substances refused extension of time for compliance.

On the basis of data before him, the Commissioner cannot find that there is no undue risk to the public health in extending the effective date of the Food Additives Amendment of 1958 as it applies to safrole, oil of sassafras, dihydrosafrole, and iso-safrole. The requests for extensions are denied, and any prior sanction or approval of the use of these articles in food is hereby canceled.

§ 121.90 Further extensions of effective date of statute for certain food additives as direct additives to food.

On the basis of data supplied following enactment of Public Law 88-625 (78 Stat. 1002; 21 U.S.C. 342, note), and consistent with the provisions of that statute and the policy prescribed in § 121.84, and findings that no undue risk to the public health is involved in the interim use of the following food additives, the food additives listed may be used in foods, in accordance with good manufacturing practice, under the specified use conditions until December 31, 1965, or until regulations shall have been issued establishing or denying tolerances or exemptions from the requirements of tolerances, in accordance with section 409 of the act, whichever occurs first:

Specified uses or restrictions

1,1-Bis(p-chlorophenyl)-2,2,2-trichloroethanol

Bromide, inorganic_--

and vegetables; limit 1 p.p.m. in food.

From use on fresh mint leaves for control of mites; limit 100 p.p.m. as residue in mint oil. Resulting from fumigation with methyl bromide and/or ethylene dibromide, to control pest infestations; limit 50 p.p.m. in processed food.

Component of chewing gum base.

etables; limit 1 p.p.m. of ester.

cial detergents for raw products; use of detergent followed by water rinse.

Acetophenone (phenyl methyl ketone)
Allyl butyrate_____.

Allyl caproate (2-propenyl hexanoate, allyl hexanoate).

Allyl heptylate (allyl heptoate, allyl oenanthate, allyl heptanoate).

Beechwood creosote, Fagus spp-

Benzyl disulfide___

Benzyl isoeugenol (isoeugenol benzyl ether, 1-benzyl

oxy-2-methoxy-4-propenyl benzene).

Cade oil (juniper tar, empyreumatic wood oil);

Juniperus oxycedrus L.

Caryophyllene acetate..

Caryophyllene alcohol.

Product

Glyoxal

Hexamethylenetetramine

Mineral oil consisting of virgin petroleum distillates refined to meet the following ultraviolet absorbance limits as determined by analytical methods available on request from the Commissioner of Food and Drugs:

Maximum

Specified uses or restrictions As an insolubilizing agent for starch or protein in coatings for paper and paperboard in food packaging; limit 10% of the weight of starch or protein fraction of the binder system. Component of phenolic molding com

pound for use in processing, holding, packaging, or transporting food.

For uses wherever mineral oil is permitted for use as a component of nonfood articles complying with §§ 121.2519, 121.2520, 121.2531 (for use only in rolling of metallic foil and sheet stock), 121.2535, 121.2536, 121.2557, and 121.2562.

Component of burlap bags for packaging dry food.

Oxalic acid.

Petroleum hydrocarbons, aliphatic: Initial boiling point 315° F. minimum; final boiling point 650° F. maximum; ultraviolet absorptivity 0.04 liter per gram centimeter maximum at 290 millimicrons. Petroleum polymerization resins obtained from the polymerization of dienes and olefins from lowboiling petroleum stocks. p-Phenylethyl phenol------

Pigment blue 15 (phthalocyanine blue), Color Index No. 74160.

Pigment green 7 (phthalocyanine green), Color Index No. 74260.

Component of insecticide for control of infestation in food-storage and food-processing areas; limit 20 p.p.m. in food.

Component of phenolic molding com

pound for use in processing, holding, packaging, or transporting food.

Adjuvant for insecticides in foodprocessing plants; limit 1 p.p.m. residue on foods.

Component of coating of paper and paperboard for food packaging.

Component of phenolic molding compound for use in processing, holding, packaging, or transporting food.

Colorant in food containers and equipment.

Do.