Toxic Free Food Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 3699 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. IN THE HOUSE OF REPRESENTATIVES JUNE 4, 2021 Ms. DELAURO introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Toxic Free Food Act 4 of 2021’’. 5 SEC. 2. DIRECTED RULEMAKING REGARDING SUBSTANCES 6 GENERALLY RECOGNIZED AS SAFE. 7 (a) DIRECTED RULEMAKING.— 8 VerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3699.IH H3699 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3699 IH (1) IN GENERAL.—The Secretary of Health and 1 Human Services, acting through the Commissioner 2 of Food and Drugs, shall— 3 (A) not later than 180 days after the date 4 of enactment of this Act, publish a proposed re- 5 vision to the final rule titled ‘‘Substances Gen- 6 erally Recognized as Safe’’, published by the 7 Food and Drug Administration on August 17, 8 2016 (81 Federal Register 54960 et seq.); and 9 (B) not later than 90 days after the close 10 of the period for public comment on the revision 11 proposed pursuant to subparagraph (A), pub- 12 lish a final revision to such final rule. 13 (2) CONTENTS.—The revision required by para- 14 graph (1) shall include each of the following: 15 (A) The revision shall prohibit a manufac- 16 turer from marketing a substance as GRAS, or 17 manufacturing or selling food that contains a 18 substance the manufacturer has determined to 19 be GRAS, unless— 20 (i) the Secretary has received notice 21 that the manufacturer has determined 22 such substance to be GRAS; and 23 (ii) the manufacturer has provided the 24 Secretary with supporting information suf- 25 VerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3699.IH H3699 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3699 IH ficient to understand the basis of the de- 1 termination, including, as required by the 2 Federal Food, Drug, and Cosmetic Act (21 3 U.S.C. 301 et seq.)— 4 (I) the cumulative effects of the 5 substance, as required under section 6 409 of such Act (21 U.S.C. 348); 7 (II) an adequately protective use 8 of safety factors; and 9 (III) application of a margin of 10 safety to take into account the im- 11 pacts of exposures during critical win- 12 dows of development and on vulner- 13 able populations. 14 (B) The revision shall require the Sec- 15 retary— 16 (i) to make each determination that is 17 submitted pursuant to subparagraph 18 (A)(i), and the supporting information sub- 19 mitted pursuant to subparagraph (A)(ii), 20 publicly available on the website of the 21 Food and Drug Administration; and 22 (ii) provide a period of at least 90 23 days for the Secretary and the public to re- 24 view each such determination and object, if 25 VerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3699.IH H3699 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3699 IH appropriate, in order to ensure that the 1 substance involved is safe taking into ac- 2 count the factors in listed in section 3 409(c)(5) of the Federal Food, Drug, and 4 Cosmetic Act (21 U.S.C. 348(c)(5)). 5 (C) The revision shall clarify that newly 6 synthesized or novel chemical substances cannot 7 be GRAS. 8 (D) The revision shall clarify that carcino- 9 genic substances cannot be GRAS. 10 (E) The revision shall— 11 (i) prohibit the Secretary from relying 12 on the determination of experts with con- 13 flicts of interest when determining a sub- 14 stance to be GRAS; and 15 (ii) incorporate the recommendations 16 in the draft guidance titled ‘‘Best Practices 17 for Convening a GRAS Panel’’, issued by 18 the Food and Drug Administration in No- 19 vember, 2017, and measures to strengthen 20 the recommendations in such guidance. 21 (F) The revision shall create a process that 22 requires the Secretary to systematically reassess 23 any substance that was determined to be GRAS 24 VerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3699.IH H3699 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3699 IH if such determination did not meet the revised 1 standards for such a determination. 2 (b) FOOD ADVISORY COMMITTEE.—Not later than 3 180 days after the date of enactment of this Act, the Sec- 4 retary shall— 5 (1) reestablish the Food Advisory Committee to 6 work with the Secretary on the reassessment stand- 7 ards, process, and methods necessary to complete 8 the work described in subsection (a)(2)(F); and 9 (2) provide such Committee with such staffing 10 and resources as are necessary to complete such 11 work. 12 (c) DEFINITIONS.—In this subsection: 13 (1) The term ‘‘GRAS’’ means, with respect to 14 a substance, generally recognized, among experts 15 qualified by scientific training and experience to 16 evaluate its safety, as having been adequately shown 17 through scientific procedures (or, in the case of a 18 substance used in food prior to January 1, 1958, 19 through either scientific procedures or experience 20 based on common use in food) to be safe under the 21 conditions of its intended use, as described in section 22 201(s) of the Federal Food, Drug, and Cosmetic Act 23 (21 U.S.C. 321). 24 VerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3699.IH H3699 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 3699 IH (2) The term ‘‘Secretary’’ means the Secretary 1 of Health and Human Services. 2 Æ VerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H3699.IH H3699 kjohnson on DSK79L0C42PROD with BILLS