Page:United States Statutes at Large Volume 72 Part 1.djvu/1827

 72 S T A T. ]

PUBLIC LAW 8 6 - 9 2 9 - S E P T. 6, 1968

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(b) Section 402' (a), as amended, of such Act is further amended 21 USC 342. by striking out the period at the end thereof and inserting in lieu thereof a semicolon and the following: "or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409." (c) The first sentence of section 406(a) of such Act is amended by 21 USC 346. striking out "clause (2) " wherever it appears in such sentence and inserting in lieu thereof "clause (2)(A) ". SEC. 4. Chapter IV of such Act is amended by adding at the end ^2} ^^^ ^^' "^ seq. thereof the following new section: "FOOD ADDITIVES

"Unsafe Food Additives "SEC. 409. (a) A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 402(a), unless— "(1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (i) of this section; or "(2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used. While such a regulation relating to a food additive is in effect, a food shall not, by reason of bearing or containing such an additive in accordance with the regulation, be considered adulterated within the meaning of clause (1) of section 402(a). "Petition To Establish Safety "(b)(1) Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used. "(2) Such petition shall, in addition to any explanatory or supporting data, contain— " (A) the name and all pertinent information concerning such food additive, including, where available, its chemical icfentity and composition; " (B) a statement of the conditions of the proposed use of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including specimens of its proposed labeling; " (C) all relevant data bearing on the physical or other technical effect such additive is intended to produce, and the quantity of such additive required to produce such effect; " (D) a description of practicable methods for determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use; and " (E) full reports of investigations made with respect to the safety for use of such additive^ including full information as to the methods and controls used in conducting such investigations. "(3) Upon rec[uest of the Secretary, the petitioner shall furnish (or^ if the petitioner is not the manufacturer of such additive, the petitioner shall have the manufacturer of such additive furnish, with-

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