Ensuring Safe and Toxic-Free Foods Act of 2022

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 Center for Food Safety and Applied Nutrition of the Food and Drug Administration the Office of Food Chemical Safety Reassessment, and for other purposes. 1. Short title This Act may be cited as the Ensuring Safe and Toxic-Free Foods Act of 2022 2. Directed rulemaking regarding substances generally recognized as safe (a) Definitions In this section: (1) GRAS The term GRAS generally recognized as safe for use in food (2) Reproductive or developmental toxicity The term reproductive or developmental toxicity (3) Secretary The term Secretary (4) Vulnerable human populations The term vulnerable human population (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 (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revision to such final rule; and (C) not later than 180 days after the date of enactment of this Act, finalize the draft guidance titled Best Practices for Convening a GRAS Panel (2) Contents The revision required by subparagraphs (A) and (B) of paragraph (1) shall include each of the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 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 required 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 indicating that the weight of evidence shows the substance has not been found to induce cancer when ingested by humans or animals; and (IV) information indicating that the weight of evidence 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) (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 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) (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 guidance described in paragraph (1)(C). (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. 3. Office of Food Chemical Safety Reassessment Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. 21 U.S.C. 348 409A. Office of Food Chemical Safety Reassessment (a) Definitions In this section: (1) Food contact substance The term food contact substance (2) Generally recognized as safe for use in food The term generally recognized as safe for use in food (3) Prior-sanctioned substance The term prior-sanctioned substance (4) Reproductive or developmental toxicity The term reproductive or developmental toxicity (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 (A) infants, children, and adolescents; (B) pregnant or breastfeeding women; (C) the elderly; (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 the enactment of this section, the Secretary shall establish within the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, an office to be known as the Office of Food Chemical Safety Reassessment Office (c) Safety reassessments Not less frequently than once every 3 years beginning in calendar year 2023, 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; (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 to the extent that data are available to derive safety factors for each vulnerable human population. (e) Unsafe A substance or class of substances shall be deemed unsafe under this section within the meaning of section 409 if— (1) the substance or class has been found to induce cancer when ingested by man or animal; or (2) the substance or class has been found to induce reproductive or developmental toxicity when ingested by man or animal, including through an endocrine mode of action. (f) First substances subject to reassessment The first 10 substances or classes of substances reassessed by the Secretary under subsection (b) shall be the following: (1) Perfluoroalkyl substances and polyfluoroalkyl substances. (2) Ortho-phthalates. (3) The class of bisphenols. (4) Titanium dioxide. (5) Potassium bromate. (6) Perchlorate. (7) Butylated hydroxyanisole (BHA). (8) Butylated hydroxytoluene (BHT). (9) Brominated vegetable oil (BVO). (10) Propyl paraben. (g) Subsequent substances Prior to selecting subsequent substances or classes of substances to reassess in addition to those listed in subsection (f), 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. (h) Notice prior to commencement Prior to commencing a reassessment of a substance or class of substances under subsection (f) or (g), 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. (i) 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 (1) the standards for reassessments conducted under this section; and (2) the process and methods necessary to complete the work of the Office. (j) 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. .

Summary: Ensuring Safe and Toxic-Free Foods Act of 2022 This bill requires the Food and Drug Administration to incorporate certain requirements into its regulations about Generally Recognized As Safe (GRAS) food substances, including specific restrictions on substances that cause cancer or human reproductive or developmental toxicity. The bill also establishes an Office of Food Chemical Safety Reassessment to reassess the safety of GRAS and other specified substances.