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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Toxic Free Food Act 

5 of 2021’’. 

6 SEC. 2. DIRECTED RULEMAKING REGARDING SUBSTANCES 

7 GENERALLY RECOGNIZED AS SAFE. 

8 (a) DIRECTED RULEMAKING.— 


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1 (1) IN GENERAL.—The Secretary of Health and 

2 Human Services, acting through the Commissioner 

3 of Food and Drugs, shall— 

4 (A) not later than 180 days after the date 

5 of enactment of this Act, publish a proposed re6 vision to the final rule titled ‘‘Substances Gen7 erally Recognized as Safe’’, published by the 

8 Food and Drug Administration on August 17, 

9 2016 (81 Federal Register 54960 et seq.); and 

10 (B) not later than 90 days after the close 

11 of the period for public comment on the revision 

12 proposed pursuant to subparagraph (A), pub13 lish a final revision to such final rule. 

14 (2) CONTENTS.—The revision required by para15 graph (1) shall include each of the following: 

16 (A) The revision shall prohibit a manufac17 turer from marketing a substance as GRAS, or 

18 manufacturing or selling food that contains a 

19 substance the manufacturer has determined to 

20 be GRAS, unless— 

21 (i) the Secretary has received notice 

22 that the manufacturer has determined 

23 such substance to be GRAS; and 

24 (ii) the manufacturer has provided the 

25 Secretary with supporting information sufVerDate Sep 11 2014 04:53 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3699.IH H3699

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1 ficient to understand the basis of the de2 termination, including, as required by the 

3 Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 301 et seq.)— 

5 (I) the cumulative effects of the 

6 substance, as required under section 

7 409 of such Act (21 U.S.C. 348); 

8 (II) an adequately protective use 

9 of safety factors; and 

10 (III) application of a margin of 

11 safety to take into account the im12 pacts of exposures during critical win13 dows of development and on vulner14 able populations. 

15 (B) The revision shall require the Sec16 retary— 

17 (i) to make each determination that is 

18 submitted pursuant to subparagraph 

19 (A)(i), and the supporting information sub20 mitted pursuant to subparagraph (A)(ii), 

21 publicly available on the website of the 

22 Food and Drug Administration; and 

23 (ii) provide a period of at least 90 

24 days for the Secretary and the public to re25 view each such determination and object, if 


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1 appropriate, in order to ensure that the 

2 substance involved is safe taking into ac3 count the factors in listed in section 

4 409(c)(5) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 348(c)(5)). 

6 (C) The revision shall clarify that newly 

7 synthesized or novel chemical substances cannot 

8 be GRAS. 

9 (D) The revision shall clarify that carcino10 genic substances cannot be GRAS. 

11 (E) The revision shall— 

12 (i) prohibit the Secretary from relying 

13 on the determination of experts with con14 flicts of interest when determining a sub15 stance to be GRAS; and 

16 (ii) incorporate the recommendations 

17 in the draft guidance titled ‘‘Best Practices 

18 for Convening a GRAS Panel’’, issued by 

19 the Food and Drug Administration in No20 vember, 2017, and measures to strengthen 

21 the recommendations in such guidance. 

22 (F) The revision shall create a process that 

23 requires the Secretary to systematically reassess 

24 any substance that was determined to be GRAS 


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1 if such determination did not meet the revised 

2 standards for such a determination. 

3 (b) FOOD ADVISORY COMMITTEE.—Not later than 

4 180 days after the date of enactment of this Act, the Sec5 retary shall— 

6 (1) reestablish the Food Advisory Committee to 

7 work with the Secretary on the reassessment stand8 ards, process, and methods necessary to complete 

9 the work described in subsection (a)(2)(F); and 

10 (2) provide such Committee with such staffing 

11 and resources as are necessary to complete such 

12 work. 

13 (c) DEFINITIONS.—In this subsection: 

14 (1) The term ‘‘GRAS’’ means, with respect to 

15 a substance, generally recognized, among experts 

16 qualified by scientific training and experience to 

17 evaluate its safety, as having been adequately shown 

18 through scientific procedures (or, in the case of a 

19 substance used in food prior to January 1, 1958, 

20 through either scientific procedures or experience 

21 based on common use in food) to be safe under the 

22 conditions of its intended use, as described in section 

23 201(s) of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 321). 


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1 (2) The term ‘‘Secretary’’ means the Secretary 

2 of Health and Human Services. 

Æ 


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