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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3387 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 3387

  To direct the Secretary of Health and Human Services to update and 
  clarify its rule on substances generally recognized as safe and to 
 establish within the Food and Drug Administration the Office of Food 
  Chemical Safety, Dietary Supplements, and Innovation, and for other 
                               purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            December 4, 2023

 Mr. Markey (for himself, Mr. Booker, Mr. Blumenthal, and Ms. Warren) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
  To direct the Secretary of Health and Human Services to update and 
  clarify its rule on substances generally recognized as safe and to 
 establish within the Food and Drug Administration the Office of Food 
  Chemical Safety, Dietary Supplements, and Innovation, 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 ``Ensuring Safe and Toxic-Free Foods 
Act of 2023''.

SEC. 2. DIRECTED RULEMAKING REGARDING SUBSTANCES GENERALLY RECOGNIZED 
              AS SAFE.

    (a) Definitions.--In this section:
            (1) GRAS.--The term ``GRAS'', with respect to the use of a 
        substance in food, has the meaning given the term ``generally 
        recognized as safe for use in food'' in section 409A(a) of the 
        Federal Food, Drug, and Cosmetic Act, as added by section 3.
            (2) Reproductive or developmental toxicity.--The term 
        ``reproductive or developmental toxicity'' has the meaning 
        given such term in such section 409A(a).
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services, acting through the Commissioner 
        of Food and Drugs.
            (4) Vulnerable human populations.--The term ``vulnerable 
        human population'' has the meaning given such term in such 
        section 409A(a).
    (b) Directed Rulemaking.--
            (1) In general.--The Secretary shall--
                    (A) not later than 1 year 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 Fed. Reg. 54960);
                    (B) not later than 180 days after the close of the 
                period for public comment on the revision proposed 
                under subparagraph (A), publish a final revision to 
                such final rule; and
                    (C) not later than 180 days after the date of 
                enactment of this Act, publish a plan for monitoring 
                industry compliance with the rules, regulations, and 
                guidance of the Food and Drug Administration relating 
                to GRAS, including the December 2022 guidance titled 
                ``Best Practices for Convening a GRAS Panel''.
            (2) Contents.--The revision required by subparagraphs (A) 
        and (B) of 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 made a final 
                        determination, which is conveyed to the 
                        manufacturer in writing, that the Secretary has 
                        received sufficient notice from the 
                        manufacturer that the manufacturer has 
                        determined such substance to be GRAS under the 
                        conditions of its intended use; and
                            (ii) the manufacturer has provided the 
                        Secretary with supporting information 
                        sufficient to understand the basis of the 
                        determination, including--
                                    (I) the cumulative effects of the 
                                substance, as required under section 
                                409 of the Federal Food, Drug, and 
                                Cosmetic Act (21 U.S.C. 348);
                                    (II) an adequately protective use 
                                of safety factors, as described under 
                                such section 409, including safety 
                                factors to account for the particular 
                                sensitivities of vulnerable human 
                                populations, to the extent that data 
                                are available to derive safety factors 
                                for each vulnerable human population;
                                    (III) information demonstrating 
                                that the weight of evidence analysis 
                                shows the substance has not been found 
                                to induce cancer when ingested by 
                                humans or animals; and
                                    (IV) information demonstrating that 
                                the weight of evidence analysis shows 
                                the substance has not been found to 
                                induce reproductive or developmental 
                                toxicity when ingested by humans or 
                                animals, including through an endocrine 
                                mode of action.
                    (B) The revision shall require--
                            (i) the Secretary 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;
                            (ii) 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 listed in 
                        subparagraph (A) and in paragraphs (3) through 
                        (5) of section 409(c) of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 348(c)); and
                            (iii) the Secretary's objection, or 
                        decision not to object, to be considered final 
                        agency action.
                    (C) The revision shall clarify that substances that 
                are known (or reasonably anticipated) to cause cancer 
                in humans or animals identified by the National 
                Toxicology Program cannot be GRAS.
                    (D) The revision shall clarify that substances that 
                show clear evidence (or some evidence) of human 
                reproductive or developmental toxicity identified by 
                the National Toxicology Program cannot be GRAS.
                    (E) The revision shall clarify that any substance 
                that was not marketed for use in foods in the United 
                States before issuance of the revised rule cannot be 
                GRAS and shall be approved by the Secretary through a 
                food additive petition as required by section 409(c) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                348(c)) prior to being marketed in food.
                    (F) The revision shall--
                            (i) incorporate standards prohibiting 
                        conflict of interests among experts providing 
                        data for substances submitted for GRAS review; 
                        and
                            (ii) incorporate measures to strengthen the 
                        recommendations in the December 2022 guidance 
                        of the Food and Drug Administration titled 
                        ``Best Practices for Convening a GRAS Panel''.
                    (G) The revision shall create a process that 
                requires the Secretary to systematically reassess any 
                substance that was determined to be GRAS if the initial 
                determination did not meet the revised standards for 
                such a determination, in accordance with the procedures 
                and resources in section 409A of the Federal Food, 
                Drug, and Cosmetic Act, as added by section 3.

SEC. 3. OFFICE OF FOOD CHEMICAL SAFETY, DIETARY SUPPLEMENTS, AND 
              INNOVATION.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by inserting after section 409 (21 U.S.C. 348) 
the following:

``SEC. 409A. OFFICE OF FOOD CHEMICAL SAFETY, DIETARY SUPPLEMENTS, AND 
              INNOVATION.

    ``(a) Definitions.--In this section:
            ``(1) Food contact substance.--The term `food contact 
        substance' has the meaning given such term in section 
        409(h)(6).
            ``(2) Generally recognized as safe for use in food.--The 
        term `generally recognized as safe for use in food' means, with 
        respect to the use of a substance in food, that the substance 
        is 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).
            ``(3) Prior-sanctioned substance.--The term `prior-
        sanctioned substance' means a substance described in paragraph 
        (4) of section 201(s).
            ``(4) Reproductive or developmental toxicity.--The term 
        `reproductive or developmental toxicity' means--
                    ``(A) adverse effects on the reproductive systems 
                of female or male humans or animals, that may include 
                alterations to the female or male reproductive system 
                development, the endocrine system, fertility, 
                pregnancy, pregnancy outcomes, or modifications in 
                other functions that are dependent on the integrity of 
                the reproductive system; or
                    ``(B) adverse effects on developing organisms that 
                result from exposure prior to conception, during the 
                prenatal period, or until the time of sexual maturity.
            ``(5) Vulnerable human population.--The term `vulnerable 
        human population' means a human population that is subject to 
        the potential for disproportionate exposure to, or the 
        potential for disproportionate adverse effects from exposure 
        to, a chemical substance or mixture, including--
                    ``(A) infants, children, and adolescents;
                    ``(B) pregnant, postpartum, or breastfeeding women;
                    ``(C) older adults;
                    ``(D) individuals with preexisting medical 
                conditions;
                    ``(E) workers who may be exposed to chemical 
                substances and mixtures;
                    ``(F) residents in communities subject to 
                disproportionate exposures or adverse effects; and
                    ``(G) members of any other appropriate population 
                identified by the Secretary.
    ``(b) Establishment.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall establish within the 
Food and Drug Administration an office, to be known as the `Office of 
Food Chemical Safety, Dietary Supplements, and Innovation' (referred to 
in this section as the `Office'), to evaluate and reassess the safety, 
within the meaning of section 409, of substances and classes of 
substances, including food additives, food contact substances, 
substances generally recognized as safe for use in food, color 
additives, and prior-sanctioned substances.
    ``(c) Safety Reassessments.--Not later than 3 years after the date 
on which the Office is established, and not less frequently than once 
every 3 years thereafter, the Office shall--
            ``(1) reassess the safety of not less than 10 of the 
        substances or classes of substances described in subsection 
        (b); and
            ``(2) issue final regulations--
                    ``(A) determining that any such substance or class 
                of substance is safe within the meaning of section 409 
                and establishing the conditions of use, if any, under 
                which any such substance or class of substances can be 
                used safely within the meaning of such section; or
                    ``(B) determining that any such substance or class 
                of substances is unsafe within the meaning of such 
                section.
    ``(d) Considerations.--In determining, for the purposes of this 
section, whether a substance or class of substances is unsafe within 
the meaning of section 409, the Secretary shall consider among other 
relevant factors--
            ``(1) the cumulative effects of the substance, as described 
        under such section 409; and
            ``(2) an adequately protective use of safety factors, as 
        described under such section 409, including safety factors to 
        account for the particular sensitivities of vulnerable human 
        populations.
    ``(e) Notice Prior to Selecting Substances for Reassessment.--Prior 
to selecting substances or classes of substances to reassess under 
subsection (c), the Secretary shall post a notice in the Federal 
Register requesting information and recommendations on which substances 
and classes should be reassessed. The information shall include 
substance or class name, uses, and data relating to the actual and 
potential hazards and impact on public health.
    ``(f) Notice Prior to Commencement.--Prior to commencing a 
reassessment of a substance or class of substances under subsection 
(c), the Secretary shall post a notice in the Federal Register 
requesting information on any uses of such substance or class in food, 
including as a prior-sanctioned substance, food contact substance, or 
substance that is generally recognized as safe for use in food. The 
information requested shall include when the uses commenced, the 
specific conditions of use, how they were determined to be safe, 
scientific evidence relevant to the safety of the substance that has 
become available since its use in food commenced, and the anticipated 
amounts that may be found in food.
    ``(g) Food Chemical Committee of the Science Board.--Not later than 
180 days after the date of enactment of this section, the Secretary 
shall establish a standing Food Chemical Committee (referred to in this 
subsection as the `Committee') within the Science Board to the Food and 
Drug Administration and provide resources and staffing as are necessary 
for the Committee to meet regularly and complete their work. The 
Committee shall advise the Secretary with respect to the process and 
methods necessary to complete the work of the Office.
    ``(h) Rule of Construction.--Nothing in this section alters the 
authority or duties of the Secretary with respect to the administration 
and enforcement of section 409.''.
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