II 

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. 

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 ‘‘Ensuring Safe and 

5 Toxic-Free Foods Act of 2023’’. 


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1 SEC. 2. DIRECTED RULEMAKING REGARDING SUBSTANCES 

2 GENERALLY RECOGNIZED AS SAFE. 

3 (a) DEFINITIONS.—In this section: 

4 (1) GRAS.—The term ‘‘GRAS’’, with respect to 

5 the use of a substance in food, has the meaning 

6 given the term ‘‘generally recognized as safe for use 

7 in food’’ in section 409A(a) of the Federal Food, 

8 Drug, and Cosmetic Act, as added by section 3. 

9 (2) REPRODUCTIVE OR DEVELOPMENTAL TOX10 ICITY.—The term ‘‘reproductive or developmental 

11 toxicity’’ has the meaning given such term in such 

12 section 409A(a). 

13 (3) SECRETARY.—The term ‘‘Secretary’’ means 

14 the Secretary of Health and Human Services, acting 

15 through the Commissioner of Food and Drugs. 

16 (4) VULNERABLE HUMAN POPULATIONS.—The 

17 term ‘‘vulnerable human population’’ has the mean18 ing given such term in such section 409A(a). 

19 (b) DIRECTED RULEMAKING.— 

20 (1) IN GENERAL.—The Secretary shall— 

21 (A) not later than 1 year after the date of 

22 enactment of this Act, publish a proposed revi23 sion to the final rule titled ‘‘Substances Gen24 erally Recognized as Safe’’, published by the 

25 Food and Drug Administration on August 17, 

26 2016 (81 Fed. Reg. 54960); 


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1 (B) not later than 180 days after the close 

2 of the period for public comment on the revision 

3 proposed under subparagraph (A), publish a 

4 final revision to such final rule; and 

5 (C) not later than 180 days after the date 

6 of enactment of this Act, publish a plan for 

7 monitoring industry compliance with the rules, 

8 regulations, and guidance of the Food and 

9 Drug Administration relating to GRAS, includ10 ing the December 2022 guidance titled ‘‘Best 

11 Practices for Convening a GRAS Panel’’. 

12 (2) CONTENTS.—The revision required by sub13 paragraphs (A) and (B) of paragraph (1) shall in14 clude each of the following: 

15 (A) The revision shall prohibit a manufac16 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 made a final de21 termination, which is conveyed to the man22 ufacturer in writing, that the Secretary 

23 has received sufficient notice from the 

24 manufacturer that the manufacturer has 

25 determined such substance to be GRAS 


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1 under the conditions of its intended use; 

2 and 

3 (ii) the manufacturer has provided the 

4 Secretary with supporting information suf5 ficient to understand the basis of the de6 termination, including— 

7 (I) the cumulative effects of the 

8 substance, as required under section 

9 409 of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 348); 

11 (II) an adequately protective use 

12 of safety factors, as described under 

13 such section 409, including safety fac14 tors to account for the particular sen15 sitivities of vulnerable human popu16 lations, to the extent that data are 

17 available to derive safety factors for 

18 each vulnerable human population; 

19 (III) information demonstrating 

20 that the weight of evidence analysis 

21 shows the substance has not been 

22 found to induce cancer when ingested 

23 by humans or animals; and 

24 (IV) information demonstrating 

25 that the weight of evidence analysis 


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1 shows the substance has not been 

2 found to induce reproductive or devel3 opmental toxicity when ingested by 

4 humans or animals, including through 

5 an endocrine mode of action. 

6 (B) The revision shall require— 

7 (i) the Secretary to make each deter8 mination that is submitted pursuant to 

9 subparagraph (A)(i), and the supporting 

10 information submitted pursuant to sub11 paragraph (A)(ii), publicly available on the 

12 website of the Food and Drug Administra13 tion; 

14 (ii) a period of at least 90 days for 

15 the Secretary and the public to review each 

16 such determination and object, if appro17 priate, in order to ensure that the sub18 stance involved is safe taking into account 

19 the factors listed in subparagraph (A) and 

20 in paragraphs (3) through (5) of section 

21 409(c) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 348(c)); and 

23 (iii) the Secretary’s objection, or deci24 sion not to object, to be considered final 

25 agency action. 


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1 (C) The revision shall clarify that sub2 stances that are known (or reasonably antici3 pated) to cause cancer in humans or animals 

4 identified by the National Toxicology Program 

5 cannot be GRAS. 

6 (D) The revision shall clarify that sub7 stances that show clear evidence (or some evi8 dence) of human reproductive or developmental 

9 toxicity identified by the National Toxicology 

10 Program cannot be GRAS. 

11 (E) The revision shall clarify that any sub12 stance that was not marketed for use in foods 

13 in the United States before issuance of the re14 vised rule cannot be GRAS and shall be ap15 proved by the Secretary through a food additive 

16 petition as required by section 409(c) of the 

17 Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 348(c)) prior to being marketed in food. 

19 (F) The revision shall— 

20 (i) incorporate standards prohibiting 

21 conflict of interests among experts pro22 viding data for substances submitted for 

23 GRAS review; and 

24 (ii) incorporate measures to strength25 en the recommendations in the December 


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1 2022 guidance of the Food and Drug Ad2 ministration titled ‘‘Best Practices for 

3 Convening a GRAS Panel’’. 

4 (G) The revision shall create a process that 

5 requires the Secretary to systematically reassess 

6 any substance that was determined to be GRAS 

7 if the initial determination did not meet the re8 vised standards for such a determination, in ac9 cordance with the procedures and resources in 

10 section 409A of the Federal Food, Drug, and 

11 Cosmetic Act, as added by section 3. 

12 SEC. 3. OFFICE OF FOOD CHEMICAL SAFETY, DIETARY SUP13 PLEMENTS, AND INNOVATION. 

14 Chapter IV of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 341 et seq.) is amended by inserting after 

16 section 409 (21 U.S.C. 348) the following: 

17 ‘‘SEC. 409A. OFFICE OF FOOD CHEMICAL SAFETY, DIETARY 

18 SUPPLEMENTS, AND INNOVATION. 

19 ‘‘(a) DEFINITIONS.—In this section: 

20 ‘‘(1) FOOD CONTACT SUBSTANCE.—The term 

21 ‘food contact substance’ has the meaning given such 

22 term in section 409(h)(6). 

23 ‘‘(2) GENERALLY RECOGNIZED AS SAFE FOR

24 USE IN FOOD.—The term ‘generally recognized as 

25 safe for use in food’ means, with respect to the use 


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1 of a substance in food, that the substance is gen2 erally recognized, among experts qualified by sci3 entific training and experience to evaluate its safety, 

4 as having been adequately shown through scientific 

5 procedures (or, in the case of a substance used in 

6 food prior to January 1, 1958, through either sci7 entific procedures or experience based on common 

8 use in food) to be safe under the conditions of its 

9 intended use, as described in section 201(s). 

10 ‘‘(3) PRIOR-SANCTIONED SUBSTANCE.—The 

11 term ‘prior-sanctioned substance’ means a substance 

12 described in paragraph (4) of section 201(s). 

13 ‘‘(4) REPRODUCTIVE OR DEVELOPMENTAL TOX14 ICITY.—The term ‘reproductive or developmental 

15 toxicity’ means— 

16 ‘‘(A) adverse effects on the reproductive 

17 systems of female or male humans or animals, 

18 that may include alterations to the female or 

19 male reproductive system development, the en20 docrine system, fertility, pregnancy, pregnancy 

21 outcomes, or modifications in other functions 

22 that are dependent on the integrity of the re23 productive system; or 

24 ‘‘(B) adverse effects on developing orga25 nisms that result from exposure prior to conVerDate Sep 11 2014 02:08 Dec 08, 2023 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3387.IS S3387

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1 ception, during the prenatal period, or until the 

2 time of sexual maturity. 

3 ‘‘(5) VULNERABLE HUMAN POPULATION.—The 

4 term ‘vulnerable human population’ means a human 

5 population that is subject to the potential for dis6 proportionate exposure to, or the potential for dis7 proportionate adverse effects from exposure to, a 

8 chemical substance or mixture, including— 

9 ‘‘(A) infants, children, and adolescents; 

10 ‘‘(B) pregnant, postpartum, or 

11 breastfeeding women; 

12 ‘‘(C) older adults; 

13 ‘‘(D) individuals with preexisting medical 

14 conditions; 

15 ‘‘(E) workers who may be exposed to 

16 chemical substances and mixtures; 

17 ‘‘(F) residents in communities subject to 

18 disproportionate exposures or adverse effects; 

19 and 

20 ‘‘(G) members of any other appropriate 

21 population identified by the Secretary. 

22 ‘‘(b) ESTABLISHMENT.—Not later than 1 year after 

23 the date of enactment of this section, the Secretary shall 

24 establish within the Food and Drug Administration an of25 fice, to be known as the ‘Office of Food Chemical Safety, 


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1 Dietary Supplements, and Innovation’ (referred to in this 

2 section as the ‘Office’), to evaluate and reassess the safety, 

3 within the meaning of section 409, of substances and 

4 classes of substances, including food additives, food con5 tact substances, substances generally recognized as safe 

6 for use in food, color additives, and prior-sanctioned sub7 stances. 

8 ‘‘(c) SAFETY REASSESSMENTS.—Not later than 3 

9 years after the date on which the Office is established, 

10 and not less frequently than once every 3 years thereafter, 

11 the Office shall— 

12 ‘‘(1) reassess the safety of not less than 10 of 

13 the substances or classes of substances described in 

14 subsection (b); and 

15 ‘‘(2) issue final regulations— 

16 ‘‘(A) determining that any such substance 

17 or class of substance is safe within the meaning 

18 of section 409 and establishing the conditions 

19 of use, if any, under which any such substance 

20 or class of substances can be used safely within 

21 the meaning of such section; or 

22 ‘‘(B) determining that any such substance 

23 or class of substances is unsafe within the 

24 meaning of such section. 


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1 ‘‘(d) CONSIDERATIONS.—In determining, for the pur2 poses of this section, whether a substance or class of sub3 stances is unsafe within the meaning of section 409, the 

4 Secretary shall consider among other relevant factors— 

5 ‘‘(1) the cumulative effects of the substance, as 

6 described under such section 409; and 

7 ‘‘(2) an adequately protective use of safety fac8 tors, as described under such section 409, including 

9 safety factors to account for the particular sensitivi10 ties of vulnerable human populations. 

11 ‘‘(e) NOTICE PRIOR TO SELECTING SUBSTANCES FOR

12 REASSESSMENT.—Prior to selecting substances or classes 

13 of substances to reassess under subsection (c), the Sec14 retary shall post a notice in the Federal Register request15 ing information and recommendations on which sub16 stances and classes should be reassessed. The information 

17 shall include substance or class name, uses, and data re18 lating to the actual and potential hazards and impact on 

19 public health. 

20 ‘‘(f) NOTICE PRIOR TO COMMENCEMENT.—Prior to 

21 commencing a reassessment of a substance or class of sub22 stances under subsection (c), the Secretary shall post a 

23 notice in the Federal Register requesting information on 

24 any uses of such substance or class in food, including as 

25 a prior-sanctioned substance, food contact substance, or 


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1 substance that is generally recognized as safe for use in 

2 food. The information requested shall include when the 

3 uses commenced, the specific conditions of use, how they 

4 were determined to be safe, scientific evidence relevant to 

5 the safety of the substance that has become available since 

6 its use in food commenced, and the anticipated amounts 

7 that may be found in food. 

8 ‘‘(g) FOOD CHEMICAL COMMITTEE OF THE SCIENCE

9 BOARD.—Not later than 180 days after the date of enact10 ment of this section, the Secretary shall establish a stand11 ing Food Chemical Committee (referred to in this sub12 section as the ‘Committee’) within the Science Board to 

13 the Food and Drug Administration and provide resources 

14 and staffing as are necessary for the Committee to meet 

15 regularly and complete their work. The Committee shall 

16 advise the Secretary with respect to the process and meth17 ods necessary to complete the work of the Office. 

18 ‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec19 tion alters the authority or duties of the Secretary with 

20 respect to the administration and enforcement of section 

21 409.’’. 

Æ 


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