Toxic Free Food Act of 2021

To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to update and clarify its rule on substances generally recognized as safe, and for other purposes. 1. Short title This Act may be cited as the Toxic Free Food Act of 2021 2. Directed rulemaking regarding substances generally recognized as safe (a) Directed rulemaking (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (A) not later than 180 days after the date of enactment of this Act, publish a proposed revision to the final rule titled Substances Generally Recognized as Safe (B) not later than 90 days after the close of the period for public comment on the revision proposed pursuant to subparagraph (A), publish a final revision to such final rule. (2) Contents The revision required by paragraph (1) shall include each of the following: (A) The revision shall prohibit a manufacturer from marketing a substance as GRAS, or manufacturing or selling food that contains a substance the manufacturer has determined to be GRAS, unless— (i) the Secretary has received notice that the manufacturer has determined such substance to be GRAS; and (ii) the manufacturer has provided the Secretary with supporting information sufficient to understand the basis of the determination, including, as required by the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. (I) the cumulative effects of the substance, as required under section 409 of such Act ( 21 U.S.C. 348 (II) an adequately protective use of safety factors; and (III) application of a margin of safety to take into account the impacts of exposures during critical windows of development and on vulnerable populations. (B) The revision shall require the Secretary— (i) to make each determination that is submitted pursuant to subparagraph (A)(i), and the supporting information submitted pursuant to subparagraph (A)(ii), publicly available on the website of the Food and Drug Administration; and (ii) provide a period of at least 90 days for the Secretary and the public to review each such determination and object, if appropriate, in order to ensure that the substance involved is safe taking into account the factors in listed in section 409(c)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(c)(5) (C) The revision shall clarify that newly synthesized or novel chemical substances cannot be GRAS. (D) The revision shall clarify that carcinogenic substances cannot be GRAS. (E) The revision shall— (i) prohibit the Secretary from relying on the determination of experts with conflicts of interest when determining a substance to be GRAS; and (ii) incorporate the recommendations in the draft guidance titled Best Practices for Convening a GRAS Panel (F) The revision shall create a process that requires the Secretary to systematically reassess any substance that was determined to be GRAS if such determination did not meet the revised standards for such a determination. (b) Food Advisory Committee Not later than 180 days after the date of enactment of this Act, the Secretary shall— (1) reestablish the Food Advisory Committee to work with the Secretary on the reassessment standards, process, and methods necessary to complete the work described in subsection (a)(2)(F); and (2) provide such Committee with such staffing and resources as are necessary to complete such work. (c) Definitions In this subsection: (1) The term GRAS 21 U.S.C. 321 (2) The term Secretary

Summary: Toxic Free Food Act of 2021 This bill requires the Food and Drug Administration (FDA) to revise its regulations relating to food additives that may be considered generally recognized as safe (GRAS). (A substance deemed GRAS is not subject to the premarket review requirements for food additives. A manufacturer may notify the FDA that it has determined that a substance is GRAS.) The revised regulations must prohibit a manufacturer from marketing a substance as GRAS (or manufacturing or selling a food containing that substance) unless the manufacturer has notified the FDA that it has determined that the substance is GRAS and submitted certain information supporting this position, including information about the substance's cumulative effects. The FDA must maintain a public website with each GRAS submission and supporting information. There must be a period of at least 90 days for the FDA and the public to review and object to such submissions. Furthermore, under the revised regulations, newly synthesized or novel chemicals and carcinogenic substances may not be deemed GRAS. The FDA may not rely on experts with conflicts of interest when making a GRAS determination. The FDA must also (1) incorporate in its rules certain best practices for convening a GRAS panel, (2) create a process to systematically reassess any substances previously determined to be GRAS, and (3) reestablish the Food Advisory Committee to assist with establishing standards and procedures for reassessing substances.