II 

114TH CONGRESS 

2D SESSION S. 3412 

To ban the use of bisphenol A in food containers, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 28, 2016 

Mr. MARKEY introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To ban the use of bisphenol A in food containers, 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 ‘‘Ban Poisonous Addi5 tives Act of 2016’’. 

6 SEC. 2. BAN ON USE OF BISPHENOL A IN FOOD AND BEV7 ERAGE CONTAINERS. 

8 (a) TREATMENT OF BISPHENOL A AS ADULTER9 ATING THE FOOD OR BEVERAGE.— 

10 (1) IN GENERAL.—For purposes of applying 

11 section 402(a)(6) of the Federal Food, Drug, and 


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1 Cosmetic Act (21 U.S.C. 342(a)(6)), a food con2 tainer (which for purposes of this Act includes a 

3 beverage container) that is composed, in whole or in 

4 part, of bisphenol A, or that can release bisphenol 

5 A into food (as defined for purposes of the Federal 

6 Food, Drug, and Cosmetic Act), shall be treated as 

7 a container described in such section (relating to 

8 containers composed, in whole or in part, of a poi9 sonous or deleterious substance which may render 

10 the contents injurious to health). 

11 (2) APPLICABILITY.— 

12 (A) REUSABLE FOOD CONTAINERS.—Para13 graph (1) shall apply to reusable food con14 tainers on the date that is 180 days after the 

15 date of enactment of this Act. 

16 (B) OTHER FOOD CONTAINERS.—Para17 graph (1) shall apply to any food container that 

18 is packed with food and is introduced or deliv19 ered for introduction into interstate commerce 

20 on or after the date that is 180 days after the 

21 date of enactment of this Act. 

22 (b) WAIVER.— 

23 (1) IN GENERAL.—The Secretary, after public 

24 notice and opportunity for comment, may grant to 

25 any facility (as that term is defined in section 415 


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1 of the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 350d)) that manufactures, processes, packs, 

3 holds, or sells the particular food product or prod4 ucts, a waiver of the treatment described in sub5 section (a). 

6 (2) APPLICABILITY.—A waiver granted to a fa7 cility under paragraph (1) may only be applicable to 

8 a certain type of food container or containers, as 

9 used for a particular food product or group of simi10 lar products containing similar foods. 

11 (3) REQUIREMENT FOR WAIVER.—The Sec12 retary may only grant a waiver under paragraph (1) 

13 to a facility, if such facility— 

14 (A) demonstrates that it is not techno15 logically feasible to— 

16 (i) replace bisphenol A in the certain 

17 type of container or containers for such 

18 particular food product or products; or 

19 (ii) use an alternative container that 

20 does not contain bisphenol A for such par21 ticular food product or products; and 

22 (B) submits to the Secretary a plan and 

23 timeline for removing bisphenol A from such 

24 type of container or containers for that food 

25 product or products. 


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1 (4) LABELING.— 

2 (A) IN GENERAL.—Any product for which 

3 the Secretary grants such a waiver shall display 

4 a prominent warning on the label that the con5 tainer contains bisphenol A that states, 

6 ‘‘bisphenol A (BPA) is a chemical that can 

7 leach into food and may harm prenatal develop8 ment and the health of children and adults’’. 

9 (B) ADDITIONAL REQUIREMENT.—The 

10 prominent warning required under subpara11 graph (A) shall include information to ensure 

12 adequate public awareness of potential health 

13 effects associated with bisphenol A. 

14 (5) DURATION.— 

15 (A) INITIAL WAIVER.—Any waiver granted 

16 under paragraph (1) to a facility for a food con17 tainer or containers shall be valid for not longer 

18 than 1 year after the date on which subsection 

19 (a) is applicable to such food container or con20 tainers. 

21 (B) RENEWAL OF WAIVER.—The Secretary 

22 may renew any waiver granted under paragraph 

23 (1) for periods of not more than 1 year, pro24 vided that the Secretary reaffirms that it is not 

25 technologically feasible to replace bisphenol A in 


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1 such type of container or containers for such 

2 particular food product or products or use an 

3 alternative container that does not contain 

4 bisphenol A for such particular food product or 

5 products. 

6 (c) SUBSTANCES USED TO REPLACE BISPHENOL

7 A.—The Secretary shall, to the extent possible, promote, 

8 facilitate, and incentivize the use of safer alternatives to 

9 replace bisphenol A, and as such bisphenol A shall not 

10 be replaced in food containers with substances that— 

11 (1) are known or are likely human carcinogens; 

12 (2) have been found by the Environmental Pro13 tection Agency to be persistent, bioaccumulative, and 

14 toxic; 

15 (3) cause reproductive or developmental tox16 icity; or 

17 (4) are endocrine disrupting chemicals. 

18 (d) REEXAMINATION OF APPROVED FOOD ADDI19 TIVES, EFFECTIVE FOOD CONTACT SUBSTANCE NOTIFI20 CATIONS, AND SUBSTANCES THAT ARE GENERALLY REC21 OGNIZED AS SAFE.— 

22 (1) PLAN AND SCHEDULE.—Not later than 1 

23 year after the date of enactment of this Act, after 

24 opportunity for comment, the Secretary, acting 

25 through the Commissioner of Food and Drugs shall 


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1 publish a plan and schedule for the selection of sub2 stances under paragraph (2) and the review of sub3 stances under paragraph (5). 

4 (2) SELECTION OF SUBSTANCES.—Not later 

5 than 1 year after the date of enactment of this Act 

6 and not less than once every 3 years thereafter, the 

7 Secretary, acting through the Commissioner of Food 

8 and Drugs, shall, based on the factors under para9 graph (4), select substances to review under para10 graph (5). Such selection shall be made from 

11 among— 

12 (A) substances authorized as a food addi13 tive under any regulations issued under section 

14 409 of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 348); 

16 (B) substances that are the subject of any 

17 sanction or approval as described in section 

18 201(s)(4) of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 321(s)(4)); 

20 (C) substances that are the subject of an 

21 effective food contact substance notification, as 

22 described in section 409(h) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 

24 348(h)); 


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1 (D) substances that are generally recog2 nized as safe, as listed in part 182 of title 21, 

3 Code of Federal Regulations (or any successor 

4 regulations); 

5 (E) direct food substances affirmed as gen6 erally recognized as safe, as listed in part 184 

7 of title 21, Code of Federal Regulations (or any 

8 successor regulations); and 

9 (F) indirect food substances affirmed as 

10 generally recognized as safe, as listed in part 

11 186 of title 21, Code of Federal Regulations (or 

12 any successor regulations). 

13 (3) NOTICE AND COMMENT.—The selection of 

14 substances under paragraph (2) shall be subject to 

15 notice and comment. 

16 (4) PRIORITIES.—In selecting substances under 

17 paragraph (2), the Secretary shall take into consid18 eration the following factors: 

19 (A) Whether, based on new scientific infor20 mation, the Secretary determines that there is 

21 a possibility that there is no longer a reasonable 

22 certainty that no harm will result from aggre23 gate exposure to such substance through food 

24 containers composed, in whole or in part, of 

25 such substance, taking into consideration— 


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1 (i) potential adverse effects from low 

2 dose exposure; and 

3 (ii) the effects of exposure on vulner4 able human populations. 

5 (B) Whether, since the introduction of 

6 such substance into interstate commerce, there 

7 has been a significant increase in the amount of 

8 such substance found in— 

9 (i) sources of drinking water; or 

10 (ii) products that are likely to be used 

11 by vulnerable human populations. 

12 (C) Whether such substance has been ap13 proved by the Food and Drug Administration to 

14 be used in the lining of canned food. 

15 (5) REVIEW OF SUBSTANCES AND SECRETARIAL

16 DETERMINATION.— 

17 (A) IN GENERAL.—Not later than 1 year 

18 after the date on which a substance is selected 

19 under paragraph (2), the Secretary shall deter20 mine whether there is a reasonable certainty 

21 that no harm will result from aggregate expo22 sure to such substance, taking into consider23 ation— 

24 (i) potential adverse effects from low 

25 dose exposure; and 


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1 (ii) the effects of exposure on vulner2 able human populations. 

3 (B) NOTICE AND COMMENT.—The deter4 mination made under subparagraph (A) shall be 

5 subject to notice and comment. 

6 (6) REMEDIAL ACTION.— 

7 (A) IN GENERAL.—Upon a determination 

8 under paragraph (5) that there is not a reason9 able certainty that no harm will result from ag10 gregate exposure to a substance through food 

11 containers composed, in whole or in part, of 

12 such substance— 

13 (i) if the substance is not defined as 

14 a food contact substance under the Federal 

15 Food, Drug, and Cosmetic Act, the sub16 stance shall be subject to subsections 

17 (a)(3) and (h) of section 409 of the Fed18 eral Food, Drug, and Cosmetic Act (21 

19 U.S.C. 348(a)(3) and (h)), subject to the 

20 process under subparagraph (B); 

21 (ii) if the substance is defined as a 

22 food contact substance under the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 

24 301 et seq.), the substance shall be subject 

25 to subparagraph (C); and 


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1 (iii) the Secretary shall, to the extent 

2 practicable, promote, facilitate, and 

3 incentivize the use of safer alternatives as 

4 replacements for such substance. 

5 (B) TREATMENT OF SUBSTANCES THAT

6 ARE NOT DEFINED AS FOOD CONTACT SUB7 STANCES.—The process under this subpara8 graph is as follows: 

9 (i) One year after the determination 

10 under paragraph (5) for a substance sub11 ject to the process under this subpara12 graph— 

13 (I) any regulation issued under 

14 section 409 of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 

16 348) that authorizes any use of the 

17 substance as a food additive (includ18 ing sections 177.1580, 177.1440, 

19 177.2280, and 175.300(b)(3)(viii) of 

20 title 21, Code of Federal Regulations, 

21 as in effect on the date of enactment 

22 of this Act); and 

23 (II) any sanction or approval as 

24 described in section 201(s)(4) of such 


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1 Act (21 U.S.C. 321(s)(4)) regarding 

2 such substance, 

3 shall be deemed revoked. 

4 (ii) Upon receipt of a food contact no5 tification for a food contact substance con6 taining a substance subject to the process 

7 under this subparagraph, the Secretary 

8 shall review the notification under the au9 thority described in subsections (a)(3) and 

10 (h) of section 409 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 

12 348(a)(3) and (h)). 

13 (C) TREATMENT OF SUBSTANCES DEFINED

14 AS FOOD CONTACT SUBSTANCES.— 

15 (i) One year after the determination 

16 under paragraph (5) for a substance that 

17 is subject to this subparagraph, all effec18 tive notifications for the use of such sub19 stance under the authority described in 

20 subsections (a)(3) and (h) of section 409 

21 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 348(a)(3) and (h)) shall be 

23 reviewed by the Secretary. 

24 (ii) Upon receipt of a food contact no25 tification for a food contact substance conVerDate Sep 11 2014 03:52 Oct 01, 2016 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3412.IS S3412

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1 taining a substance that is subject to this 

2 subparagraph, the Secretary shall review 

3 the notification under the authority de4 scribed in subsections (a)(3) and (h) of 

5 section 409 of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 348(a)(3) 

7 and (h)). 

8 (e) SAVINGS PROVISION.—Nothing in this Act shall 

9 affect the right of a State, political subdivision of a State, 

10 or Indian tribe to adopt or enforce any regulation, require11 ment, liability, or standard of performance that is more 

12 stringent than a regulation, requirement, liability, or 

13 standard of performance under this Act or that— 

14 (1) applies to a product category not described 

15 in this Act; or 

16 (2) requires the provision of a warning of risk, 

17 illness, or injury associated with the use of food con18 tainers composed, in whole or in part, of bisphenol 

19 A. 

20 (f) DEFINITIONS.—For purposes of this section: 

21 (1) ENDOCRINE DISRUPTING CHEMICAL.—The 

22 term ‘‘endocrine disrupting chemical’’ means an ex23 ogenous agent that causes adverse effects, such as 

24 by interfering with the production, release, trans25 port, metabolism, binding, action, or elimination of 


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1 the natural hormones in the body responsible for the 

2 maintenance of homeostasis and the regulation of 

3 developmental processes. 

4 (2) REUSABLE FOOD CONTAINER.—The term 

5 ‘‘reusable food container’’ means a reusable food 

6 container that does not contain a food item when it 

7 is introduced or delivered for introduction into inter8 state commerce. 

9 (3) SAFER ALTERNATIVE.—The term ‘‘safer al10 ternative’’ means an option, that is safer for humans 

11 and the environment than the existing chemical or 

12 process, including— 

13 (A) chemical or process substitution; 

14 (B) chemical or process reformulation or 

15 redesign; and 

16 (C) chemical or process elimination or 

17 phase-out. 

18 (4) SECRETARY.—The term ‘‘Secretary’’ means 

19 the Secretary of Health and Human Services. 

20 (5) VULNERABLE HUMAN POPULATION.—The 

21 term ‘‘vulnerable human population’’ means a 

22 human population that is subject to the potential for 

23 disproportionate exposure to, or the potential for 

24 disproportionate adverse effect from exposure to, a 

25 chemical substance or mixture, including— 


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1 (A) infants, children, and adolescents; 

2 (B) pregnant women; 

3 (C) the elderly; 

4 (D) individuals with preexisting medical 

5 conditions; 

6 (E) workers who may be exposed to chem7 ical substances and mixtures; 

8 (F) residents in communities subject to 

9 disproportionate exposures; and 

10 (G) members of any other appropriate pop11 ulation identified by the Secretary. 

12 SEC. 3. AMENDMENTS TO SECTION 409 OF THE FEDERAL 

13 FOOD, DRUG, AND COSMETIC ACT. 

14 Section 409(h) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 348(h)) is amended— 

16 (1) in paragraph (1)— 

17 (A) by striking ‘‘manufacturer or supplier 

18 of a food contact substance may’’ and inserting 

19 ‘‘manufacturer or supplier of a food contact 

20 substance shall’’; 

21 (B) by inserting ‘‘(A)’’ after ‘‘notify the 

22 Secretary of’’; 

23 (C) by striking ‘‘, and of’’ and inserting ‘‘; 

24 (B)’’; and 


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1 (D) by striking the period after ‘‘sub2 section (c)(3)(A)’’ and inserting ‘‘; (C) the de3 termination of the manufacturer or supplier 

4 that no adverse health effects result from low5 dose exposures to the food contact substance; 

6 and (D) the determination of the manufacturer 

7 or supplier that the substance has not been 

8 shown, after tests which are appropriate for the 

9 evaluation of the safety of food contact sub10 stances, to cause reproductive or developmental 

11 toxicity in humans or animals.’’; and 

12 (2) by striking paragraph (6) and inserting the 

13 following: 

14 ‘‘(6) In this section— 

15 ‘‘(A) the term ‘food contact substance’ means 

16 any substance intended for use as a component of 

17 materials used in manufacturing, packing, pack18 aging, transporting, or holding food if such use is 

19 not intended to have any technical effect in such 

20 food; and 

21 ‘‘(B) the term ‘reproductive or developmental 

22 toxicity’ means biologically adverse effects on the re23 productive systems of female or male humans or ani24 mals, or on developing organisms that may result 

25 from exposure prior to conception, during prenatal 


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1 development, or until the time of sexual maturation, 

2 that may include female or male reproductive system 

3 development, fertility, pregnancy, pregnancy out4 comes, or modifications in other functions that are 

5 dependent on the integrity of the reproductive sys6 tem or effects on the developing organism, including 

7 death, structural abnormality, altered growth, or 

8 functional deficiency.’’. 

9 SEC. 4. REPORT TO CONGRESS. 

10 Not later than 2 years after the date of enactment 

11 of this Act and at least once during every 2-year period 

12 thereafter, the Secretary shall submit a report to the Com13 mittee on Energy and Commerce of the House of Rep14 resentatives and the Committee on Health, Education, 

15 Labor, and Pensions of the Senate. Such report shall in16 clude— 

17 (1) a list of waivers granted under section 

18 2(b)(1), including a description of the basis for each 

19 such waiver; 

20 (2) a list of substances selected for review 

21 under section 2(c)(2) and the anticipated timeline 

22 for future selections of additional substances; 

23 (3) for each substance reviewed under section 

24 2(c)(5), the outcome of such review, and the antici25 pated timeline for review of additional substances; 


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1 (4) a description of all remedial action taken 

2 under section 2(c)(6); and 

3 (5) for bisphenol A and any other substance de4 termined not to have a reasonable certainty of no 

5 harm under section 2(c)(5), a review of the potential 

6 alternatives to that substance that are available or 

7 being developed for use in food and beverage con8 tainers. 

Æ 


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