Toxic Free Food Act of 2021
Bill: H.R.3699 | Sponsor: Rep. DeLauro, Rosa L. (D-CT)
Policy area: Agriculture and Food

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.

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Toxic Free Food Act of 2021''.

SEC. 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'', published by the Food and Drug 
                Administration on August 17, 2016 (81 Federal Register 
                54960 et seq.); and
                    (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'', issued by the Food 
                        and Drug Administration in November, 2017, and 
                        measures to strengthen the recommendations in 
                        such guidance.
                    (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'' means, with respect to a substance, 
        generally recognized, among experts qualified by scientific 
        training and experience to evaluate its safety, as having been 
        adequately shown through scientific procedures (or, in the case 
        of a substance used in food prior to January 1, 1958, through 
        either scientific procedures or experience based on common use 
        in food) to be safe under the conditions of its intended use, 
        as described in section 201(s) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321).
            (2) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
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