85TH CONGRESS 1ST SESSION H. R. 6747 IN THE HOUSE OF REPRESENTATIVES APRIL 9, 1957 Mr. HARES introduced the following bill; which was referred to the Committee on Interstate and Foreign Commerce A BILL To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of chemical additives which have not been adequately tested to establish their safety. 1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That this Act may be cited as the "Chemical Additives 4 Amendment of 1957". 5 SEC. 2. Section 201, as amended, of the Federal Food, 6 Drug, and Cosmetic Act is further amended by adding at 7 the end of such section the following new paragraph: 8 "(s) (1) The term 'chemical additive' means, except 9 as otherwise provided in subparagraph (2), any substance I 2 1 the intended use of which results or may result, directly or 2 indirectly, in its becoming a component or otherwise 3 affecting the characteristics of any food (including any sub4 stance intended to preserve or alter food or for any other 5 purpose in producing, manufacturing, packing, processing, 6 preparing, treating, packaging, transporting, or holding 7 food; and including any radioactive material intended for 8 any such use or as a source for the irradiation of food), if 9 such substance is not generally recognized, among experts 10 qualified by scientific training and experience to evaluate 11 its toxicity or other potentiality for harm, as having been 12 adequately shown through scientific procedures or through 13 prolonged use in food to be safe for use under the conditions 14 of its intended use. 15 "(2) Such term does not include (A) a pesticide 16 chemical in or on a raw agricultural commodity, or a pesti17 cide chemical when intended solely for use in the production, 18 storage, or transportation of any raw agricultural commodity; 19 or (B) any substance used in accordance with a sanction or 20 approval granted prior to the enactment of this paragraph 21 pursuant to this Act or to the Meat Inspection Act of March 22 4, 1907, 34 Stat. 1260, as amended and extended (21 23 U. S. C. 71 and the following)." 24 SEO. 3. Section 201 (f) of such Act is amended to 25 read as follows: ་ 1 2 3 "(f) The term 'food' means (1) articles used for food or drink for man or other animals, (2) chewing gum, (3) 3 articles used for components of any such article, and (4) 4 chemical additives." 5 SEC. 4. (a) Clause (2) of section 402 (a), as amended, 6 of such Act is further amended to read as follows: "(2) (A) if it bears or contains any added poisonous or added deleterious substance (except a pesticide chemical in or on a raw agricultural commodity and except a chemical additive) which is unsafe within the meaning of section 406, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 408, or (C) if it is, or it bears or contains, any chemical additive which is unsafe within the meaning of section 409: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 408 and such raw agricultural commodity has been subjected to processing by cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of sections 406 and 409, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent 4 1 possible in good manufacturing practice and the concen 2 tration of such residue in the processed food when ready 3 4 to eat is not greater than the tolerance prescribed for the raw agricultural commodity." 5 (b) The first sentence of section 406 (a) of such Act 6 is amended by striking out "clause (2)" wherever it appears 7 in such sentence and inserting in lieu thereof "clause (2) 9 SEC. 5. Chapter IV of such Act is amended by adding 10 at the end thereof the following new section: 11 12 13 "CHEMICAL ADDITIVES "UNSAFE CHEMICAL ADDITIVES "SEC. 409. (a) A chemical additive shall, with respect 14 to any particular use or intended use of such additive, be 15 deemed to be unsafe for the purposes of the application of 16 clause (2) (C) of section 402 (a), unless '(1) the use or intended use of such additive con forms to the terms of an exemption which is in effect pursuant to subsection (j) of this section; or "(2) there is in effect, and the use or intended use of such additive is in conformity with, a regulation issued under this section announcing the conditions (including any directions or other labeling or packaging requirements contained in such regulation) under which such additive may be safely used. 5 1 While such a regulation relating to a chemical additive is in 2 effect, a food shall not, by reason of bearing or containing 3 such an additive in accordance with the regulation, be con4 sidered adulterated within the meaning of clause (1) or (2) 5 (C) of section 402 (a). 6 7 "PETITION TO ESTABLISH SAFETY "(b) (1) Any interested person may, with respect to 8 any intended use or uses of a chemical additive, file with 9 the Secretary a petition proposing the issuance of a regulation 10 announcing the conditions under which such additive may 11 be safely used. 12 "(2) Such petition shall, in addition to setting forth 13 the regulation proposed by the petitioner and stating reason14 able grounds in support of the petition, contain or be accom15 panied by 16 17 18 "(A) the name and all pertinent information concerning such chemical additive, including where avail able its chemical identity and composition; "(B) (i) a statement of the conditions of the pro posed use or uses of such additive, including all direc 21 tions, recommendations, and suggestions proposed for 24 the use of such additive, and including specimens of its proposed labeling; and (ii) all relevant data bearing on the functional value of such additive; "(C) a full description of the methods used in, and |