Postmarket assessment of food additives, color additives, and food substances generally recognized as safe

Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding after section 409A (as added by section 2) the following: 409B. Postmarket assessment of food additives, color additives, and food substances generally recognized as safe (a) In general If the Secretary receives a citizen petition or a notice from a State governmental official regarding concerns about the safety of a food additive for which 1 or more regulations prescribing conditions of safe use have been issued under section 409, a color additive used in accordance with the requirements of section 721, or a food substance generally recognized as safe included on the list described in section 409A(c), or if the Secretary determines through the Secretary’s initiative that such a concern exists, the Secretary may reevaluate the additive or substance in accordance with section 409, 721, or 409A, as applicable, and, as appropriate— (1) with respect to a food additive, amend or revoke the 1 or more regulations issued under section 409 with respect to the food additive; (2) with respect to a color additive, amend or revoke the 1 or more regulations issued under section 409 with respect to the food additive; and (3) with respect to a food substance generally recognized as safe— (A) determine the food substance to be a food additive subject to the requirements of section 409; and (B) by rulemaking under section 553 of title 5, United States Code, remove the food substance from the list described in subsection 409A(c). (b) Priority considerations In considering citizen petitions and notices from State governmental officials received under subsection (a), the Secretary shall give priority to petitions and notices regarding food additives, color additives, and food substances generally recognized as safe for which clear and convincing scientific evidence supports the concerns raised in the petition or notice. (c) Safety information The Secretary shall publish in the Federal Register a request for safety information for any food substance subject to reevaluation under subsection (a). (d) Review requirements (1) In general Any determination, reevaluation, or final action taken by the Secretary under this section regarding the safety, exclusion, delisting, or reclassification of a food additive, color additive, or food substance generally recognized as safe shall be subject to— (A) review and recommendation by individuals serving in positions in the Food and Drug Administration under career appointments and who have relevant scientific and regulatory expertise; and (B) the notice and comment rulemaking procedures under section 553 of title 5, United States Code. (2) Limitation The Secretary may not delegate the review under paragraph (1)(A) to— (A) an individual occupying a position for which appointment is made by the President; or (B) an individual who is not serving in a position in the Food and Drug Administration under a career appointment..