86th Congress, H. R. 7847 June 29, 1960 AN ACT To make the uniform law relating to the record on review of agency orders (Public Law 85-791) applicable to the judicial review of orders issued under the Federal Aviation Act of 1958 and the Food Additives Amendment of 1958. 74 STAT. 255. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection (c) Federal Aviaof section 1006 of the Federal Aviation Act of 1958 (72 Stat. 795) is tion Act of amended to read as follows: "(c) A copy of the petition shall, upon filing, be forthwith transmitted to the Board or Administrator by the clerk of the court, and the Board or Administrator shall thereupon file in the court the record, if any, upon which the order complained of was entered, as provided in section 2112 of title 28, United States Code.” 1958, amendment. 49 USC 1486. ment. 21 USC 348. SEC. 2. The first and second sentences of paragraph (2) of subsection Federal Food, (g) of section 409 of the Federal Food, Drug, and Cosmetic Act, as Drug, and Cosadded by the Food Additives Amendment of 1958 (72 Stat. 1788), metic Act, amendare amended to read as follows: "A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28, United States Code. Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive, to affirm or set aside the order complained of in whole or in part. Until the filing of the record the Secretary may modify or set aside his order." Approved June 29, 1960. 86th Congress, S. 2197 July 12, 1960 AN ACT 74 STAT. 397. To protect the public health by amending the Federal Food, Drug, and Cosmetic Act so as to authorize the use of suitable color additives in or on foods, drugs, and cosmetics, in accordance with regulations prescribing the conditions (including maximum tolerances) under which such additives may be safely used. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may Color Additive be cited as the "Color Additive Amendments of 1960". TITLE I-AMENDMENTS TO THE FEDERAL FOOD, DEFINITIONS SEC. 101. Section 201, as amended, of the Federal Food, Drug, and Cosmetic Act is further amended as follows: Amendments of 1960. 52 Stat. 1040; 21 USC 321. (a) Paragraph (s) of such section (defining the term "food addi- 72 Stat. 1784. tive") is amended by redesignating clause (3) as clause (4), and by inserting immediately before clause (4), as so redesignated, the following new clause: 66 "(3) a color additive; or". (b) Paragraph (t) of such section is redesignated and otherwise amended to read as follows: "(u) The term 'safe', as used in paragraph (s) of this section and in sections 409 and 706, has reference to the health of man or animal." (c) There is inserted, immediately after paragraph (s) of such section, the following new paragraph: "(t) (1) The term 'color additive' means a material which (A) is a dye, pigment, or other substance made by a process of synthesis or similar artífice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and "(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring. "(2) The term 'color' includes black, white, and intermediate grays. "(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest." COLORS OR COLORED ARTICLES-WHEN DEEMED TO BE ADULTERATED OR Food SEC. 102. (a) (1) Clause (2) (A) of section 402 (a), as amended, 52 Stat. 1040. of such Act (relating to food deemed adulterated by reason of unsafe 21 USC 342. additives) is further amended by striking out the matter within the parentheses and inserting in lieu thereof the following: "other than 52 Stat. 1046. 21 USC 342. 52 Stat. 1058. 21 USC 376. 21 USC 343. 52 Stat. 1049. 21 USC 351. 21 USC 376. 52 Stat. 1050. 21 USC 352. 52 Stat. 1054. 21 USC 361. 21 USC 376. 21 USC 362. 21 USC 346. 21 USC 354. 21 USC 364. 21 USC 371. 74 STAT. 398. one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive". (2) Section 402(c), as amended, of such Act (relating to food deemed adulterated by reason of uncertified coal-tar color) is amended to read as follows: "(c) If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 706 (a)." (3) Section 403 of such Act (relating to the circumstances under which food is deemed misbranded) is amended by adding at the end thereof the following new paragraph: "(m) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 706." Drugs (b) (1) Clause (4) of section 501 (a) of such Act (relating to drugs deemed adulterated by reason of uncertified coal tar color) is amended to read as follows: "(4) if (A) it is a drug which bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 706(a), or (B) it is a color additive the intended use of which in or on drugs is for purposes of coloring only and is unsafe within the meaning of section 706 (a)." (2) Section 502 of such Act (relating to the circumstances under which drugs are deemed misbranded) is amended by adding at the end thereof the following new paragraph: "(m) If it is a color additive the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, as may be contained in regulations issued under section 706." Cosmetics (c) (1) Section 601 (e) of such Act (relating to cosmetics, other than hair dyes, deemed adulterated by reason of uncertified coal tar color) is amended to read as follows: "(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 706 (a).” (2) Section 602 of such Act (relating to the circumstances under which cosmetics shall be deemed to be misbranded) is amended by adding at the end thereof the following new paragraph: "(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 706. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601 (a)).” REGULATIONS TO ASSURE SAFETY OF COLOR ADDITIVES FOR FOODS, DRUGS, SEC. 103. (a) Such Act is further amended by— (1) repealing subsection (b) of section 406 and striking out the subsection designation "(a)" after "SEC. 406." in such section; (2) repealing section 504; (3) repealing section 604; and (4) amending section 701 (e) by (A) striking out “406 (a) or 74 STAT. 399. (b)" and inserting in lieu thereof "406"; (B) striking out "504, or 604,"; and (C) inserting the word "or" after "501(b),". (b) Section 706 of such Act is amended to read as follows: "LISTING AND CERTIFICATION OF COLOR ADDITIVES FOR FOODS, DRUGS, AND COSMETICS "When Color Additives Deemed Unsafe 52 Stat. 1058. 21 USC 376. "SEC. 706. (a) A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or cosmetics, be deemed unsafe for the purposes of the application of section 402 (c), section 52 Stat. 1047, 501 (a) (4), or section 601 (e), as the case may be, unless1049, 1054. (1)(A) there is in effect, and such additive and such use are 21 USC 342, in conformity with, a regulation issued under subsection (b) of 351, 361. this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or "(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section. While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulter ated within the meaning of clause (1) of section 402 (a) if such article 21 USC 342, is a food, or within the meaning of section 601(a) if such article is a 361. cosmetic other than a hair dye (as defined in the last sentence of section 601(a)). "Listing of Colors "(b) (1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations. "(2)(A) Such regulations may list any color additive for use generally in or on food, or in or on drugs, or in or on cosmetics, if the Secretary finds that such additive is suitable and may safely be employed for such general use. "(B) If the data before the Secretary do not establish that the additive satisfies the requirements for listing such additive on the applicable list pursuant to subparagraph (A) of this paragraph, or if the proposal is for listing such additive for a more limited use or uses, such regulations may list such additive only for any more limited use or uses for which it is suitable and may safely be employed. "(3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely employed for such use or uses (including, but not limited to, specifications, hereafter in this section referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the article or articles in or on which it is used; specifications as to the manner in which such additive 21 USC 321. 21 USC 371. 74 STAT. 400. may be added to or used in or on such article or articles; and directions or other labeling or packaging requirements for such additive). "(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term 'food additive' because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 201 (s). "(5) (A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors— "(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs, or cosmetics because of the use of the additive; "(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet; (iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and "(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such additive in or on any article of food, drug, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive. "(B) A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal. "(C) (i) In any proceeding for the issuance, amendment, or repeal of a regulation listing a color additive, whether commenced by a proposal of the Secretary on his own initiative or by a proposal contained in a petition, the petitioner, or any other person who will be adversely affected by such proposal or by the Secretary's order issued in accordance with paragraph (1) of section 701(e) if placed in effect, may request, within the time specified in this subparagraph, that the petition or order thereon, or the Secretary's proposal, be referred to an advisory committee for a report and recommendations with respect to any matter arising under subparagraph (B) of this paragraph, which is involved in such proposal or order and which requires the exercise of scientific judgment. Upon such request, or if the Secretary within such time deems such a referral necessary, the Secretary shall forthwith appoint an advisory committee under subparagraph (D) of this paragraph and shall refer to it, together with all the data before him, such matter arising under subparagraph (B) for study thereof |