Reassessments

Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348), as amended by section 3, is further amended by adding at the end the following: (m) Reassessments (1) In general Not later than 3 years after the date of enactment of this subsection, and at least every 3 years thereafter, the Secretary shall systematically reassess the safety (including the safety of conditions of use), within the meaning of section 409, of at least 10 of the following substances (or classes thereof): (A) Food additives marketed pursuant to an order under subsection (c). (B) Any substance which was, before the date of the enactment of this subsection, considered generally recognized as safe. (C) Color additives. (D) Prior-sanctioned substances (as described in subparagraph (D) of section 201(s)(1)). (E) Food contact substances. (2) Safety evaluations In conducting the reassessments under this subsection, the Secretary may require any person that manufactures, introduces, delivers for introduction, or receives a food substance described in paragraph (1) in interstate commerce to conduct, and submit to the Secretary, safety evaluations of such substance. Such a safety evaluation shall include, with respect to such substance, updated information on— (A) estimates of dietary exposure among the United States population; (B) the cumulative effects of such substance; (C) hazard, dose response, and exposure; (D) 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) whether the weight of the evidence shows that such substance has not been found to be carcinogenic; (F) whether 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 as the Secretary may specify in regulation. (3) Revoking statement to not object If the Secretary determines, with respect to a substance described in paragraph (1)(B), based on information received under paragraph (2) and publicly available information, that a concern about the safety of the substance, or the intended use of the substance, exists, the Secretary— (A) may revoke a written statement previously issued by the Secretary to not object to a determination that the substance is generally recognized as safe; and (B) shall post such revocation in the location on the website of the Food and Drug Administration referred to in subsection (l)(7). (4) Notices of substances marketed as GRAS The Secretary may require a person that manufactures, introduces, delivers for introduction, or receives a food substance described in paragraph (1) in interstate commerce that was marketed as generally recognized as safe before, on, and after the date of enactment of this subsection to submit to the Secretary a notification that such person so marketed the substance as generally recognized as safe. (5) Civil monetary penalties In the case of a violation of this subsection, the Secretary shall assess a civil penalty in accordance with section 307. (6) Authorization of appropriations There is authorized to be appropriated such sums as may be necessary to carry out this subsection..