II 

117TH CONGRESS 

2D SESSION S. 4316 

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. 

IN THE SENATE OF THE UNITED STATES 

MAY 26, 2022 

Mr. MARKEY (for himself, 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 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 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 2022’’. 


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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, finalize the draft guid7 ance titled ‘‘Best Practices for Convening a 

8 GRAS Panel’’, issued by the Food and Drug 

9 Administration in November 2017. 

10 (2) CONTENTS.—The revision required by sub11 paragraphs (A) and (B) of paragraph (1) shall in12 clude each of the following: 

13 (A) The revision shall prohibit a manufac14 turer from marketing a substance as GRAS, or 

15 manufacturing or selling food that contains a 

16 substance the manufacturer has determined to 

17 be GRAS, unless— 

18 (i) the Secretary has made a final de19 termination, which is conveyed to the man20 ufacturer in writing, that the Secretary 

21 has received sufficient notice that the man22 ufacturer has determined such substance 

23 to be GRAS under the conditions of its in24 tended use; and 


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1 (ii) the manufacturer has provided the 

2 Secretary with supporting information suf3 ficient to understand the basis of the de4 termination, including— 

5 (I) the cumulative effects of the 

6 substance, as required under section 

7 409 of the Federal Food, Drug, and 

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

9 (II) an adequately protective use 

10 of safety factors, as required under 

11 such section 409, including safety fac12 tors to account for the particular sen13 sitivities of vulnerable human popu14 lations to the extent that data are 

15 available to derive safety factors for 

16 each vulnerable human population; 

17 (III) information indicating that 

18 the weight of evidence shows the sub19 stance has not been found to induce 

20 cancer when ingested by humans or 

21 animals; and 

22 (IV) information indicating that 

23 the weight of evidence shows the sub24 stance has not been found to induce 

25 reproductive or developmental toxicity 


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1 when ingested by humans or animals, 

2 including through an endocrine mode 

3 of action. 

4 (B) The revision shall require— 

5 (i) the Secretary to make each deter6 mination that is submitted pursuant to 

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

8 information submitted pursuant to sub9 paragraph (A)(ii), publicly available on the 

10 website of the Food and Drug Administra11 tion; 

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

13 the Secretary and the public to review each 

14 such determination and object, if appro15 priate, in order to ensure that the sub16 stance involved is safe taking into account 

17 the factors listed in subparagraph (A) and 

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

19 409(c) of the Federal Food, Drug, and 

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

21 (iii) the Secretary’s objection, or deci22 sion not to object, to be considered final 

23 agency action. 

24 (C) The revision shall clarify that sub25 stances that are known (or reasonably anticiVerDate Sep 11 2014 00:46 Jun 02, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4316.IS S4316

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1 pated) to cause cancer in humans identified by 

2 the National Toxicology Program cannot be 

3 GRAS. 

4 (D) The revision shall clarify that sub5 stances that show clear evidence (or some evi6 dence) of human reproductive or developmental 

7 toxicity identified by the National Toxicology 

8 Program cannot be GRAS. 

9 (E) The revision shall clarify that any sub10 stance that was not marketed for use in foods 

11 in the United States before issuance of the re12 vised rule cannot be GRAS and shall be ap13 proved by the Secretary through a food additive 

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

15 Federal Food, Drug, and Cosmetic Act (21 

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

17 (F) The revision shall— 

18 (i) incorporate standards prohibiting 

19 conflict of interests among experts pro20 viding data for substances submitted for 

21 GRAS review; and 

22 (ii) incorporate measures to strength23 en the recommendations in the guidance 

24 described in paragraph (1)(C). 


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1 (G) The revision shall create a process that 

2 requires the Secretary to systematically reassess 

3 any substance that was determined to be GRAS 

4 if the initial determination did not meet the re5 vised standards for such a determination, in ac6 cordance with the procedures and resources in 

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

8 Cosmetic Act, as added by section 3. 

9 SEC. 3. OFFICE OF FOOD CHEMICAL SAFETY REASSESS10 MENT. 

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

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

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

14 ‘‘SEC. 409A. OFFICE OF FOOD CHEMICAL SAFETY REASSESS15 MENT. 

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

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

18 ‘food contact substance’ has the meaning given such 

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

20 ‘‘(2) GENERALLY RECOGNIZED AS SAFE FOR

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

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

23 of a substance in food, that the substance is gen24 erally recognized, among experts qualified by sci25 entific training and experience to evaluate its safety, 


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1 as having been adequately shown through scientific 

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

3 food prior to January 1, 1958, through either sci4 entific procedures or experience based on common 

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

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

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

8 term ‘prior-sanctioned substance’ means a substance 

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

10 ‘‘(4) REPRODUCTIVE OR DEVELOPMENTAL TOX11 ICITY.—The term ‘reproductive or developmental 

12 toxicity’ means— 

13 ‘‘(A) adverse effects on the reproductive 

14 systems of female or male humans or animals, 

15 that may include alterations to the female or 

16 male reproductive system development, the en17 docrine system, fertility, pregnancy, pregnancy 

18 outcomes, or modifications in other functions 

19 that are dependent on the integrity of the re20 productive system; or 

21 ‘‘(B) adverse effects on developing orga22 nisms that result from exposure prior to con23 ception, during the prenatal period, or until the 

24 time of sexual maturity. 


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

2 term ‘vulnerable human population’ means a human 

3 population that is subject to the potential for dis4 proportionate exposure to, or the potential for dis5 proportionate adverse effects from exposure to, a 

6 chemical substance or mixture, including— 

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

8 ‘‘(B) pregnant or breastfeeding women; 

9 ‘‘(C) the elderly; 

10 ‘‘(D) individuals with preexisting medical 

11 conditions; 

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

13 chemical substances and mixtures; 

14 ‘‘(F) residents in communities subject to 

15 disproportionate exposures or adverse effects; 

16 and 

17 ‘‘(G) members of any other appropriate 

18 population identified by the Secretary. 

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

20 the date of the enactment of this section, the Secretary 

21 shall establish within the Center for Food Safety and Ap22 plied Nutrition of the Food and Drug Administration, an 

23 office to be known as the ‘Office of Food Chemical Safety 

24 Reassessment’ (referred to in this section as the ‘Office’), 

25 to conduct reassessments of the safety, within the meaning 


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1 of section 409, of substances and classes of substances in2 cluding food additives, food contact substances, substances 

3 generally recognized as safe for use in food, color addi4 tives, and prior-sanctioned substances. 

5 ‘‘(c) SAFETY REASSESSMENTS.—Not less frequently 

6 than once every 3 years beginning in calendar year 2023, 

7 the Office shall— 

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

9 the substances or classes of substances described in 

10 subsection (b); and 

11 ‘‘(2) issue final regulations— 

12 ‘‘(A) determining that any such substance 

13 or class of substance is safe within the meaning 

14 of section 409 and establishing the conditions 

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

16 or class of substances can be used safely within 

17 the meaning of such section; or 

18 ‘‘(B) determining that any such substance 

19 or class of substances is unsafe within the 

20 meaning of such section. 

21 ‘‘(d) CONSIDERATIONS.—In determining, for the pur22 poses of this section, whether a substance or class of sub23 stances is unsafe within the meaning of section 409, the 

24 Secretary shall consider among other relevant factors— 


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

2 described under such section 409; 

3 ‘‘(2) an adequately protective use of safety fac4 tors, as described under such section 409 including 

5 safety factors to account for the particular sensitivi6 ties of vulnerable human populations to the extent 

7 that data are available to derive safety factors for 

8 each vulnerable human population. 

9 ‘‘(e) UNSAFE.—A substance or class of substances 

10 shall be deemed unsafe under this section within the 

11 meaning of section 409 if— 

12 ‘‘(1) the substance or class has been found to 

13 induce cancer when ingested by man or animal; or 

14 ‘‘(2) the substance or class has been found to 

15 induce reproductive or developmental toxicity when 

16 ingested by man or animal, including through an en17 docrine mode of action. 

18 ‘‘(f) FIRST SUBSTANCES SUBJECT TO REASSESS19 MENT.—The first 10 substances or classes of substances 

20 reassessed by the Secretary under subsection (b) shall be 

21 the following: 

22 ‘‘(1) Perfluoroalkyl substances and 

23 polyfluoroalkyl substances. 

24 ‘‘(2) Ortho-phthalates. 

25 ‘‘(3) The class of bisphenols. 


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1 ‘‘(4) Titanium dioxide. 

2 ‘‘(5) Potassium bromate. 

3 ‘‘(6) Perchlorate. 

4 ‘‘(7) Butylated hydroxyanisole (BHA). 

5 ‘‘(8) Butylated hydroxytoluene (BHT). 

6 ‘‘(9) Brominated vegetable oil (BVO). 

7 ‘‘(10) Propyl paraben. 

8 ‘‘(g) SUBSEQUENT SUBSTANCES.—Prior to selecting 

9 subsequent substances or classes of substances to reassess 

10 in addition to those listed in subsection (f), the Secretary 

11 shall post a notice in the Federal Register requesting in12 formation and recommendations on which substances and 

13 classes should be reassessed. The information shall include 

14 substance or class name, uses, and data relating to the 

15 actual and potential hazards and impact on public health. 

16 ‘‘(h) NOTICE PRIOR TO COMMENCEMENT.—Prior to 

17 commencing a reassessment of a substance or class of sub18 stances under subsection (f) or (g), the Secretary shall 

19 post a notice in the Federal Register requesting informa20 tion on any uses of such substance or class in food, includ21 ing as a prior-sanctioned substance, food contact sub22 stance, or substance that is generally recognized as safe 

23 for use in food. The information requested shall include 

24 when the uses commenced, the specific conditions of use, 

25 how they were determined to be safe, scientific evidence 


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1 relevant to the safety of the substance that has become 

2 available since its use in food commenced, and the antici3 pated amounts that may be found in food. 

4 ‘‘(i) FOOD CHEMICAL COMMITTEE OF THE SCIENCE

5 BOARD.—Not later than 180 days after the date of enact6 ment of this section, the Secretary shall establish a stand7 ing Food Chemical Committee (referred to in this sub8 section as the ‘Committee’) within the Science Board to 

9 the Food and Drug Administration and provide resources 

10 and staffing as are necessary for the Committee to meet 

11 regularly and complete their work. The Committee shall 

12 advise the Secretary with respect to— 

13 ‘‘(1) the standards for reassessments conducted 

14 under this section; and 

15 ‘‘(2) the process and methods necessary to com16 plete the work of the Office. 

17 ‘‘(j) RULE OF CONSTRUCTION.—Nothing in this sec18 tion alters the authority or duties of the Secretary with 

19 respect to the administration and enforcement of section 

20 409.’’. 

Æ 


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