Mr. HARRIS introduced the following bill; which was referred to the Committee on Interstate and Foreign Commerce [Omit the part struck through and insert the part printed in italic] 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 Food Additives 4 Amendment of 1957 1958". 5 SEC. 2. Section 201, as amended, of the Federal Food, 6 Drug, and Cosmetic Act is further amended by adding at 'A proposed amendment to the title appears at the end of this print. J. 25352-1 2 1 the end of such section the following new paragraph 2 paragraphs: 3 "(s) The term 'chemical additive' means, except 4 as otherwise provided in subparagraph (2), 'food additive' 5 means any substance the intended use of which results or reasonary be circeted to 6 may result, directly or indirectly, in its becoming a com7 ponent or otherwise affecting the characteristics of any food 8 (including any substance intended to preserve or alter food or 9 for any other purpose for use in producing, manufacturing, 10 packing, processing, preparing, treating, packaging, trans11 porting, or holding food; and including any radioactive ma12 terial source of ionizing radiation intended for any such use 13 or as a source for the irradiation of food), if such substance 14 is not generally recognized, among experts qualified by scien15 tific training and experience to evaluate its toxicity or other 16 potentiality for harm, as having been adequately shown 17 through scientifie procedures or through prolonged use in 18 food to be safe for use under the conditions of its intended 19 20 use. "(2) Such term does not include (A) a pesticide 21 through scientific procedures (or, in the case of a substance 22 used in food prior to the date of enactment of this paragraph, 23 through either scientific procedures or experience based on 24 common use in food) to be safe under the conditions of its 25 intended use; except that such term does not include 1 2 3 4 5 6 7 8 9 10 11 12. 13 3 "(1) a pesticide chemical in or on a raw agricultural commodity, or "(2) a pesticide chemical when intended solely to the extent that it is intended for use in the production,. : storage, or transportation of any raw agricultural com modity; or (B) "(3) any substance used in accordance with a sanotion or approval granted prior to the enactment of this paragraph pursuant to this Act or the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended and extended (21 U. S. C. 71 and the following)." following). "(t) The term 'safe', as used in paragraph (8) of this 14 section and in section 409, means without hazard to the health 15 of man or animal." 16 SEO. 3. Section 201 (f) of such Act is amended to 17 read as follows: 18 19 "(f) The term food' means (1) articles used for food or drink for man or other animals, (2) chewing gum, (8) 20 articles used for components of any such article, and (4) 21 chemical additives." 22 SEC. 4 3. (a) Clause (2) of section 402 (a), as 23 amended, of such Act is further amended to read as follows: 24 "(2) (A) if it bears or contains any added poisonous or 25 added deleterious substance (except a pesticide chemical in: 1 or on a raw agricultural commodity and except a chemical 2 food additive) which is unsafe within the meaning of section 3 406, or (B) if it is a raw agricultural commodity and it 4 bears or contains a pesticide chemical which is unsafe within 5 the meaning of section 408 (a), or (C) if it is, or it bears 6 or contains, any chemical food additive which is unsafe 7 within the meaning of section 409: Provided, That where 8 a pesticide chemical has been used in or on a raw agricultural ⚫ 9 commodity in conformity with an exemption granted or a 10 tolerance prescribed under section 408 and such raw agri11 cultural commodity has been subjected to processing by cook12 ing, freezing, dehydrating, or milling, the residue of such 13 pesticide chemical remaining in or on such processed food 14 shall, notwithstanding the provisions of sections 406 and 409, 15 not be deemed unsafe if such residue in or on the raw agri16 cultural commodity has been removed to the extent 17 possible in good manufacturing practice and the concentration 18 of such residue in the processed food when ready to eat is 19 not greater than the tolerance prescribed for the raw agri20 cultural commodity" commodity;". 21 (b) Section 402 (a), as amended, of such Act is further 22 amended by striking out the period at the end thereof and 23 inserting in lieu thereof a semicolon and the following: "or 24 (7) if it has been intentionally subjected to ionizing radiation, 25 unless the use of the ionizing radiation was in conformity 5 1 with a regulation or exemption in effect pursuant to section 2 409." 3 (c) The first sentence of section 406 (a) of such 4 Act is amended by striking out "clause (2)" wherever it 5 appears in such sentence and inserting in lieu thereof "clause 6 (2) (A)". 7 SEC. 4. Chapter IV of such Act is amended by adding 8 at the end thereof the following new section: 9 10 11 12 13 "CHEMICAL ADDITIVES "UNSAFE CHEMICAL ADDITIVES "FOOD ADDitives "Unsafe Food Additives "SEC. 409. (a) A chemical food additive shall, with 14 respect to any particular use or intended use of such additive, 15 be deemed to be unsafe for the purposes of the application 16 of clause (2) (C) of section 402 (a), unless— It and its "(1) use or intended use of such additive conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section; or it and it's "(2) there is in effect, and the use or intended use are of such additive is in conformity with, a regulation issued under this section announcing prescribing the conditions fincluding any directions or other labeling or packaging requirements contained in such regulation) under which such additive may be safely used. |