GRAS notifications

Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking the or at the end; (B) in paragraph (3), by striking the period at the end and inserting; or; and (C) by adding at the end the following: (4) the food additive is generally recognized as safe, and the procedural requirements of subsection (l) have been met with respect to the food additive.; and (2) by adding at the end the following: (l) Notices regarding use of GRAS substances (1) In general Any person that manufactures, introduces, delivers for introduction, or receives a food substance in interstate commerce that is intending to treat such food substance as generally recognized as safe (in this subsection referred to as GRAS) shall, with respect to any new use of such substance or use of a food substance that was not marketed for use in foods in the United States before the date of enactment of this subsection, submit to the Secretary a notice prescribing the conditions under which such person determined such substance is GRAS. (2) Required information A notice submitted under paragraph (1) with respect to a food substance shall include publicly available supporting data and information sufficient to demonstrate the identity and composition, the manufacturing process, the intended effect, and the safety of the food substance, used as the basis of the GRAS determination, including full reports of investigations made with respect to the safety for use of such substance, including— (A) information as to the methods and controls used in conducting such investigations; (B) information on the cumulative effects of such substance; (C) information on hazard, dose response, and exposure; (D) information on the application of adequately protective safety factors to ensure an appropriate margin of safety to take into account uncertainties in hazard identification, dose response, exposure, and sensitivities; (E) information demonstrating the analysis that the weight of the evidence shows that such substance has not been found to be carcinogenic; (F) information demonstrating the analysis that the weight of the evidence shows that such substance has not been found to induce reproductive toxicity or developmental toxicity in humans or animals, including through an endocrine mode of action; and (G) such other information that forms the recognition of safety as the Secretary may publicly specify. (3) Form of notice A notice submitted under paragraph (1) with respect to a food substance shall be submitted in such form and manner as specified in subpart E of part 170 of title 21, Code of Federal Regulations (or successor regulations). (4) Statement not to object to use A person may use a substance subject to a notice under paragraph (1) only if the Secretary has issued a written statement to not object to the determination that the substance is GRAS under the conditions prescribed in the notice. (5) Statement to object The Secretary shall issue a written statement objecting to use of a substance subject to a notice under paragraph (1) if the Secretary determines that— (A) the notice does not contain the supporting data and information described in paragraph (2); (B) with respect to any such supporting data and information that was provided by an expert, such expert appears to have a conflict of interest, as determined pursuant to guidance issued by the Secretary; or (C) such supporting data and information does not adequately support a determination that the substance is GRAS under the conditions prescribed in the notice. (6) Determination timeline (A) In general The Secretary shall— (i) not later than 180 days after the acceptance of a notice under paragraph (1), issue a written statement under paragraph (4) or (5); or (ii) provide written notice to extend the 180-day period described in subparagraph (A) for one additional 90-day period, as specified in regulations. (B) Corrections The timeline set forth in subparagraph (A) shall not be construed to limit the authority of the Secretary to correct a statement of the Secretary to not object to the determination that the substance is GRAS if new evidence is subsequently presented or discovered. (7) Public availability and comment The Secretary shall— (A) upon acceptance of a notice under paragraph (1)— (i) make such notice, and the supporting data and information described in paragraph (2), publicly available in a single location on the website of the Food and Drug Administration; and (ii) provide an opportunity for public comment for a period of not less than 60 days; and (B) upon close of the comment period, make any written statement issued under paragraph (4) or (5) publicly available in the same location. (8) Authorization of appropriations There is authorized to be appropriated such sums as may be necessary to carry out this subsection..