I 

112TH CONGRESS 

1ST SESSION H. R. 432 

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

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 25, 2011 

Mr. MARKEY (for himself, Ms. SLAUGHTER, Ms. SCHAKOWSKY, and Mr. 

MORAN) introduced the following bill; which was referred to the Committee on Energy and Commerce 

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 2011’’. 

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.— 


tjames on DSKG8SOYB1PROD with BILLS
2 

•HR 432 IH

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

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

3 Cosmetic Act (21 U.S.C. 342(a)(6)), a food con4 tainer (which for purposes of this Act includes a 

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

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

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

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

9 a container described in such section (relating to 

10 containers composed, in whole or in part, of a poi11 sonous or deleterious substance which may render 

12 the contents injurious to health). 

13 (2) APPLICABILITY.— 

14 (A) REUSABLE FOOD CONTAINERS.—Para15 graph (1) shall apply to reusable food con16 tainers on the date that is 180 days after the 

17 date of enactment of this Act. 

18 (B) OTHER FOOD CONTAINERS.—Para19 graph (1) shall apply to any food container that 

20 is packed with food and is introduced or deliv21 ered for introduction into interstate commerce 

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

23 date of enactment of this Act. 

24 (b) WAIVER.— 


tjames on DSKG8SOYB1PROD with BILLS
3 

•HR 432 IH

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

2 notice and opportunity for comment, may grant to 

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

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

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

6 holds, or sells the particular food product or prod7 ucts, a waiver of the treatment described in sub8 section (a). 

9 (2) APPLICABILITY.—A waiver granted to a fa10 cility under paragraph (1) may only be applicable to 

11 a certain type of food container or containers, as 

12 used for a particular food product or group of simi13 lar products containing similar foods. 

14 (3) REQUIREMENT FOR WAIVER.—The Sec15 retary may only grant a waiver under paragraph (1) 

16 to a facility, if such facility— 

17 (A) demonstrates that it is not techno18 logically feasible to— 

19 (i) replace bisphenol A in the certain 

20 type of container or containers for such 

21 particular food product or products; or 

22 (ii) use an alternative container that 

23 does not contain bisphenol A for such par24 ticular food product or products; and 


tjames on DSKG8SOYB1PROD with BILLS
4 

•HR 432 IH

1 (B) submits to the Secretary a plan and 

2 timeline for removing bisphenol A from such 

3 type of container or containers for that food 

4 product or products. 

5 (4) LABELING.— 

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

7 the Secretary grants such a waiver shall display 

8 a prominent warning on the label that the con9 tainer contains bisphenol A, in a manner that 

10 the Secretary shall require. 

11 (B) ADDITIONAL REQUIREMENT.—The 

12 prominent warning required under subpara13 graph (A) shall include information to ensure 

14 adequate public awareness of potential health 

15 effects associated with bisphenol A. 

16 (5) DURATION.— 

17 (A) INITIAL WAIVER.—Any waiver granted 

18 under paragraph (1) to a facility for a food con19 tainer or containers shall be valid for not longer 

20 than 1 year after the date on which subsection 

21 (a) is applicable to such food container or con22 tainers. 

23 (B) RENEWAL OF WAIVER.—The Secretary 

24 may renew any waiver granted under paragraph 

25 (1) for periods of not more than 1 year, proVerDate Mar 15 2010 03:11 Feb 03, 2011 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H432.IH H432

tjames on DSKG8SOYB1PROD with BILLS
5 

•HR 432 IH

1 vided that the Secretary reaffirms that it is not 

2 technologically feasible to replace bisphenol A in 

3 such type of container or containers for such 

4 particular food product or products or use an 

5 alternative container that does not contain 

6 bisphenol A for such particular food product or 

7 products. 

8 (c) REEXAMINATION OF APPROVED FOOD ADDI9 TIVES, EFFECTIVE FOOD CONTACT SUBSTANCE NOTIFI10 CATIONS, AND SUBSTANCES THAT ARE GENERALLY REC11 OGNIZED AS SAFE.— 

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

13 year after enactment of this Act, after opportunity 

14 for comment, the Secretary, acting through the 

15 Commissioner of Food and Drugs shall publish a 

16 plan and schedule for the selection of substances 

17 under paragraph (2) and the review of substances 

18 under paragraph (5). 

19 (2) SELECTION OF SUBSTANCES.—Not later 

20 than 1 year after enactment of this Act and not less 

21 than once every 3 years thereafter, the Secretary, 

22 acting through the Commissioner of Food and 

23 Drugs, shall, based on the factors under paragraph 

24 (4), select substances to review under paragraph (5). 

25 Such selection shall be made from among— 


tjames on DSKG8SOYB1PROD with BILLS
6 

•HR 432 IH

1 (A) substances authorized as a food addi2 tive under any regulations issued under section 

3 409 of the Federal Food, Drug, and Cosmetic 

4 Act; 

5 (B) substances that are the subject of any 

6 sanction or approval as described in section 

7 201(s)(4) of the Federal Food, Drug, and Cos8 metic Act; 

9 (C) substances that are the subject of an 

10 effective food contact substance notification, as 

11 described in section 409(h) of the Federal 

12 Food, Drug, and Cosmetic Act; 

13 (D) substances that are generally recog14 nized as safe, as listed in part 182 of title 21, 

15 Code of Federal Regulations (or any successor 

16 regulations); 

17 (E) direct food substances affirmed as gen18 erally recognized as safe, as listed in part 184 

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

20 successor regulations); and 

21 (F) indirect food substances affirmed as 

22 generally recognized as safe, as listed in part 

23 186 of title 21, Code of Federal Regulations (or 

24 any successor regulations). 


tjames on DSKG8SOYB1PROD with BILLS
7 

•HR 432 IH

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

2 substances under paragraph (2) shall be subject to 

3 notice and comment. 

4 (4) PRIORITIES.—In selecting substances under 

5 paragraph (2), the Secretary shall take into consid6 eration the following factors: 

7 (A) Whether, based on new scientific infor8 mation, the Secretary determines that there is 

9 a possibility that there is no longer a reasonable 

10 certainty that no harm will result from aggre11 gate exposure to such substance through food 

12 containers composed, in whole or in part, of 

13 such substance, taking into consideration— 

14 (i) potential adverse effects from low 

15 dose exposure; and 

16 (ii) the effects of exposure on vulner17 able populations, including pregnant 

18 women, infants, children, the elderly, and 

19 populations with high exposure to such 

20 substance. 

21 (B) Whether, since the introduction of 

22 such substance into interstate commerce, there 

23 has been a significant increase in the amount of 

24 such substance found in— 

25 (i) sources of drinking water; or 


tjames on DSKG8SOYB1PROD with BILLS
8 

•HR 432 IH

1 (ii) products that are likely to be used 

2 by vulnerable populations, including preg3 nant women, infants, children, the elderly, 

4 and populations with high exposure to such 

5 substance. 

6 (5) REVIEW OF SUBSTANCES AND SECRETARIAL

7 DETERMINATION.— 

8 (A) IN GENERAL.—No later than 1 year 

9 after the date on which a substance is selected 

10 under paragraph (2), the Secretary shall deter11 mine whether there is a reasonable certainty 

12 that no harm will result from aggregate expo13 sure to such substance, taking into consider14 ation— 

15 (i) potential adverse effects from low 

16 dose exposure; and 

17 (ii) the effects of exposure on vulner18 able populations, including pregnant 

19 women, infants, children, the elderly, and 

20 populations with high exposure to such 

21 substance. 

22 (B) NOTICE AND COMMENT.—The deter23 mination made under subparagraph (A) shall be 

24 subject to notice and comment. 

25 (6) REMEDIAL ACTION.— 


tjames on DSKG8SOYB1PROD with BILLS
9 

•HR 432 IH

1 (A) IN GENERAL.—Upon a determination 

2 under paragraph (5) that there is not a reason3 able certainty that no harm will result from ag4 gregate exposure to a substance through food 

5 containers composed, in whole or in part, of 

6 such substance— 

7 (i) if the substance is not defined as 

8 a food contact substance under the Federal 

9 Food, Drug, and Cosmetic Act, the sub10 stance shall be subject to sections 

11 409(a)(3) and 409(h) of the Federal Food, 

12 Drug, and Cosmetic Act, subject to the 

13 process under subparagraph (B); and 

14 (ii) if the substance is defined as a 

15 food contact substance under the Federal 

16 Food, Drug, and Cosmetic Act, the sub17 stance shall be subject to subparagraph 

18 (C). 

19 (B) TREATMENT OF SUBSTANCES THAT

20 ARE NOT DEFINED AS FOOD CONTACT SUB21 STANCES.—The process under this subpara22 graph is as follows: 

23 (i) One year after the determination 

24 under paragraph (5) for a substance subVerDate Mar 15 2010 03:11 Feb 03, 2011 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H432.IH H432

tjames on DSKG8SOYB1PROD with BILLS
10 

•HR 432 IH

1 ject to the process under this subpara2 graph— 

3 (I) any regulation issued under 

4 section 409 of the Federal Food, 

5 Drug, and Cosmetic Act that author6 izes any use of the substance as a 

7 food additive (including sections 

8 177.1580, 177.1440, 177.2280, and 

9 175.300(b)(3)(viii) of title 21, Code of 

10 Federal Regulations, as in effect on 

11 the date of enactment of this Act); 

12 and 

13 (II) any sanction or approval as 

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

15 Act regarding such substance, 

16 shall be deemed revoked. 

17 (ii) Upon receipt of a food contact no18 tification for a food contact substance con19 taining a substance subject to the process 

20 under this subparagraph, the Secretary 

21 shall review the notification under the au22 thority described in sections 409(a)(3) and 

23 409(h) of the Federal Food, Drug, and 

24 Cosmetic Act. 


tjames on DSKG8SOYB1PROD with BILLS
11 

•HR 432 IH

1 (C) TREATMENT OF SUBSTANCES DEFINED

2 AS FOOD CONTACT SUBSTANCES.— 

3 (i) One year after the determination 

4 under paragraph (5) for a substance that 

5 is subject to this subparagraph, all effec6 tive notifications for the use of such sub7 stance under the authority described in 

8 sections 409(a)(3) and 409(h) of the Fed9 eral Food, Drug, and Cosmetic Act shall 

10 be reviewed by the Secretary. 

11 (ii) Upon receipt of a food contact no12 tification for a food contact substance con13 taining a substance that is subject to this 

14 subparagraph, the Secretary shall review 

15 the notification under the authority de16 scribed in sections 409(a)(3) and 409(h) of 

17 the Federal Food, Drug, and Cosmetic 

18 Act. 

19 (d) SAVINGS PROVISION.—Nothing in this Act shall 

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

21 or Indian tribe to adopt or enforce any regulation, require22 ment, liability, or standard of performance that is more 

23 stringent than a regulation, requirement, liability, or 

24 standard of performance under this Act or that— 


tjames on DSKG8SOYB1PROD with BILLS
12 

•HR 432 IH

1 (1) applies to a product category not described 

2 in this Act; or 

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

4 illness, or injury associated with the use of food con5 tainers composed, in whole or in part, of bisphenol 

6 A. 

7 (e) DEFINITIONS.—For purposes of this section: 

8 (1) REUSABLE FOOD CONTAINER.—The term 

9 ‘‘reusable food container’’ means a reusable food 

10 container that does not contain a food item when it 

11 is introduced or delivered for introduction into inter12 state commerce. 

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

14 the Secretary of Health and Human Services. 

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

16 FOOD, DRUG, AND COSMETIC ACT. 

17 Subsection (h) of section 409 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 348(h)(1)) is amend19 ed— 

20 (1) in paragraph (1)— 

21 (A) by striking ‘‘manufacturer or supplier 

22 for a food contact substance may’’ and insert23 ing ‘‘manufacturer or supplier for a food con24 tact substance shall’’; 


tjames on DSKG8SOYB1PROD with BILLS
13 

•HR 432 IH

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

2 Secretary of’’; 

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

4 (B)’’; and 

5 (D) by striking the period after ‘‘sub6 section (c)(3)(A)’’ and inserting ‘‘; (C) the de7 termination of the manufacturer or supplier 

8 that no adverse health effects result from low9 dose exposures to the food contact substance; 

10 and (D) the determination of the manufacturer 

11 or supplier that the substance has not been 

12 shown, after tests which are appropriate for the 

13 evaluation of the safety of food contact sub14 stances, to cause reproductive or developmental 

15 toxicity in humans or animals.’’; and 

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

17 following: 

18 ‘‘(6) In this section— 

19 ‘‘(A) the term ‘food contact substance’ 

20 means any substance intended for use as a 

21 component of materials used in manufacturing, 

22 packing, packaging, transporting, or holding 

23 food if such use is not intended to have any 

24 technical effect in such food; and 


tjames on DSKG8SOYB1PROD with BILLS
14 

•HR 432 IH

1 ‘‘(B) the term ‘reproductive or develop2 mental toxicity’ means biologically adverse ef3 fects on the reproductive systems of female or 

4 male humans or animals, including alterations 

5 to the female or male reproductive system de6 velopment, the related endocrine system, fer7 tility, pregnancy, pregnancy outcomes, or modi8 fications in other functions that are dependent 

9 on the integrity of the reproductive system.’’. 

10 SEC. 4. REPORT TO CONGRESS. 

11 No later than two years after enactment of this Act 

12 and at least once during every two year period thereafter, 

13 the Secretary shall submit a report to the Committee on 

14 Energy and Commerce of the House of Representatives. 

15 Such report shall include— 

16 (1) a list of waivers granted under section 

17 2(b)(1), including a description of the basis each 

18 such waiver; 

19 (2) a list of substances selected for review 

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

21 for future selections of additional substances; 

22 (3) for each substance reviewed under section 

23 2(c)(5), the outcome of such review, and the antici24 pated timeline for review of additional substances; 


tjames on DSKG8SOYB1PROD with BILLS
15 

•HR 432 IH

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 


tjames on DSKG8SOYB1PROD with BILLS