Copies of both bills referred to, H.R. 7624 and S. 2197, will be included in the record at this point, together with agency reports thereon, which will be inserted in the record at this point.

(H.R. 7624 and S. 2197 and agency reports follow:)

[H.R. 7624, 86th Cong., 1st sess.]

A BILL To protect the public health by amending the Federal Food, Drug, and Cosmetle 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 be cited as the "Color Additive Amendments of 1959."

TITLE I-AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

DEFINITIONS

SEC. 101. Section 201, as amended, of the Federal Food, Drug, and Cosmetic Act is further amended as follows:

(a) Paragraph (s) of such section (defining the term "food additive") is amended by redesignating clause (3) as clause (4), and by inserting immediately before clause (4), as so redesignated, the following new clause:

"(3) a color additive; or".

(b) Paragraph (t) of such section is redesignated and otherwise amended to read as follows:

"(u) The terra '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 artifice, or extracted, isolated, or otherwise derived, with or with out 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 of purposes other than coloring.

"(2) The term 'color' includes black, white, and intermediate grays."

COLORS OR COLORED ARTICLES-WHEN DEEMED TO BE ADULTERATED OR MISBRANDED
FOODS, DRUGS, OR COSMETICS
Food

SEC. 102. (a) (1) Clause (2) (A) of section 402 (a), as amended, of such Act (relating to food deemed adulterated by reason of unsafe additives) is further amended by striking out the matter within the parentheses and inserting in lieu thereof the following: "other than 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:

"(1) 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."

(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 regulatious issued under section 706."

Cosmetics

(c) (1) Section G01(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, AND COSMETICS

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 G04; and

(4) amending section 701(e) by (A) striking out "406 (a) or (b)" and inserting in lieu thereof "406"; (B) striking out "501, or 601,"; 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

"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 501(a)(4), or section 601 (e), as the case may be, unless

"(1)(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of 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 adulterated within the meaning of clause (1) of section 402(a) if such article is a food, or within the meaning of section 601(a) if such article is a 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 wheu 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 he 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 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

"(A) that such use, under the conditions of use to be specified in the regulations, will be safe;

"(B) that practicable methods of analysis exist for determining the quantity of the pure dye and all intermediates and other impurities contained in such color additive; and

"(C) that practicable methods exist for determining the identity and quantity (i) of such additive in or on any article of food, drug, or cosmetic, and (ii) of any substance formed in or on such article because of the use of such additive,

“(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; and

"(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. "(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 to induce cancer when ingested by man or animal, or if it is found, 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 to induce cancer in nan or animal.

"(G) The Secretary shall not list a color additive under this subsection for a proposed use if the data before him show that such proposed use would promote

deception of the consumer in violation of this Act or would otherwise result in misbranding or adulteration within the meaning of this Act.

"(7) If, in the judgment of the Secretary, a tolerance limitation is required in order to assure that a proposed use of a color additive will be safe, the Secretary

"(A) shall not list the additive for such use if he finds that the data before him do not establish that such additive, if used within a safe tolerance limitation, would achieve the intended physical or other technical effect; and

"(B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the intended physical or other technical effect.

"(8) If, having regard to the aggregate quantity of color additive likely to be consumed in the diet or to be applied to the human body, the Secretary finds that the data before him fail to show that it would be safe and otherwise permissible to list a color additive (or pharmacologically related color additives) for all the uses proposed therefor and at the levels of concentration proposed, the Sec retary shall, in determining for which use or uses such additive (or such related additives) shall be or remain listed, or how the aggregate allowable safe tolerance for such additive or additives shall be allocated by him among the uses under consideration, take into account, among other relevant factors (and subject to the paramount criterion of safety), (A) the relative marketability of the articles involved as affected by the proposed uses of the color additive (or of such related additives) in or on such articles, and the relative dependence of the industries concerned on such uses; (B) the relative aggregate amounts of such color additive which he estimates would be consumed in the diet or applied to the human body by reason of the various uses and levels of concentration proposed; aud (C) the availability, if any, of other color additives suitable and safe for one or more of the uses proposed.

"CERTIFICATION OF COLORS

"(c) The Secretary shall further, by regulation, provide (1) for the certification, with safe diluents or without diluents, of batches of color additives listed pursuant to subsection (b) and conforming to the requirements for such additives established by regulations under such subsection and this subsection, and (2) for exemption from the requirement of certification in the case of any such additive, or any listing or use thereof, for which he finds such requirement not to be necessary in the interest of the protection of the public health.

"Procedure for Issuance, Amendment, or Repeal of Regulations

"(d) The provisions of section 701(e), (f), and (g) of this Act shail apply to and in all respects govern proceedings for the issuance, amendment, or repeal of regulations under subsections (b), (c), or (e) of this section (including judicial review of the Secretary's action in such proceelings) and the admissibility of transcripts of the record of such proceedings in other proceedings, except that

"(1) the Secretary's order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the requirements of section 409 (f) (2) ; and

"(2) the scope of judicial review of such order shail be in accordance with the third sentence of paragraph (2), and with the provisions of paragraph (3), of section 409 (g).

"Fees

"(e) The admitting to listing and certification of color additives, in accordance with regulations prescribed under this Act, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes.

"Exemptions

"(f) The Secretary shall by regulation (issued without regard to subsection (d)) provide for exempting from the requirements of this section any color additive or any specific type of use thereof, and any article of food, drug, or cosmetic bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health."

COLOR ADDITIVES

7

CONFIDENTIALITY OF TRADE SECRETS

SEC. 104. Section 301 (j), as amended, of such Act, probibiting disclosure of trade secrets, is amended by striking out "or 704" and inserting in lieu thereof "704, or 706".

CHANGES IN CROSS-REFERENCES AND TERMINOLOGY

SEC. 105. Such Act is further amended by

(a) striking out, in section 301 (i) thereof (relating to forgery or unauthorized use of certain identification devices), "404, 406(b), 504, 506, 507, or 604", and inserting in lieu thereof "404, 506, 507, or 706";

(b) (1) striking out, in clause (3) of section 303 (c) (relating to color manufacturer's guarantee), the word "coal-tar" wherever it appears in such clause, and (2) inserting after the word "color", wherever it appears in such clause, the word "additive"; and

(c) striking out "harmless coloring" in section 402(d) (relating to nonnutritive substances in confectionery) and inserting in lieu thereof "authorized coloring".

TITLE II-EFFECTIVE DATE, TRANSITIONAL PROVISIONS, AND
EFFECT ON OTHER LAWS

DEFINITIONS

SEC. 201. As used in this title, the term "basic Act" means the Federal Food; Drug, and Cosmetic Act; the term "enactment date" means the date of enactment of this Act; and other terms, insofar as also used in the basic Act (whether before or after enactment of this Act) shall have the same meaning as they have, or had when in effect, under the basic Act.

EFFECTIVE DATE

SEC. 202. This Act shall, subject to the provisions of section 203, take effect on the enactment date.

PROVISIONAL LISTINGS OF COMMERCIALLY ESTABLISHED COLORS

SEC. 203. (a) (1) The purpose of this section is to make possible, on an interim basis for a reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific inevstigations needed as a basis for making determinations as to listing of such additives under the basic Act as amended by this Act. A provisional listing (including a deemed provisional listing) of a color additive under this section for any use shall, unless sooner terminated or expiring under the provisions of this section, expire (A) on the closing date (as defined in paragraph (2) of this subsection) or (B) on the effective date of a listing of such additive for such use under section 706 of the basic Act, whichever date first occurs.

(2) For the purposes of this section, the term "closing date" means (A) the last day of the two and one-half year period beginning on the enactment date or (B), with respect to a particular provisional listing cor deemed provisional listing) of a color additive or use thereof, such later closing date as the Secre tary may from time to time establish pursuant to the authority of this paragraph. The Secretary way by regulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional listing for deemed provisional listing) under this section of a specified color additive, or of a specified use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgrent such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practi cable, the scientific investigations 1ecessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 of the basic Act. The Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement.