I 

113TH CONGRESS 

1ST SESSION H. R. 2248 

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

IN THE HOUSE OF REPRESENTATIVES 

JUNE 4, 2013 

Mr. MARKEY (for himself, Mr. BLUMENAUER, Mrs. CAPPS, Ms. DEGETTE, 

Ms. DELAURO, Mr. ELLISON, Ms. ESHOO, Mr. FARR, Mr. GRIJALVA, Ms. 

LOFGREN, Mrs. LOWEY, Mrs. CAROLYN B. MALONEY of New York, Ms. 

MCCOLLUM, Mr. MORAN, Mr. NADLER, Ms. PINGREE of Maine, Ms. 

SCHAKOWSKY, Ms. SLAUGHTER, Ms. SPEIER, and Ms. TSONGAS) 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 2013’’. 


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1 SEC. 2. BAN ON USE OF BISPHENOL A IN FOOD AND BEV2 ERAGE CONTAINERS. 

3 (a) TREATMENT OF BISPHENOL A AS ADULTER4 ATING THE FOOD OR BEVERAGE.— 

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

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

7 Cosmetic Act (21 U.S.C. 342(a)(6)), a food con8 tainer (which for purposes of this Act includes a 

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

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

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

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

13 a container described in such section (relating to 

14 containers composed, in whole or in part, of a poi15 sonous or deleterious substance which may render 

16 the contents injurious to health). 

17 (2) APPLICABILITY.— 

18 (A) REUSABLE FOOD CONTAINERS.—Para19 graph (1) shall apply to reusable food con20 tainers on the date that is 180 days after the 

21 date of enactment of this Act. 

22 (B) OTHER FOOD CONTAINERS.—Para23 graph (1) shall apply to any food container that 

24 is packed with food and is introduced or deliv25 ered for introduction into interstate commerce 


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

2 date of enactment of this Act. 

3 (b) WAIVER.— 

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

5 notice and opportunity for comment, may grant to 

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

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

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

9 holds, or sells the particular food product or prod10 ucts, a waiver of the treatment described in sub11 section (a). 

12 (2) APPLICABILITY.—A waiver granted to a fa13 cility under paragraph (1) may only be applicable to 

14 a certain type of food container or containers, as 

15 used for a particular food product or group of simi16 lar products containing similar foods. 

17 (3) REQUIREMENT FOR WAIVER.—The Sec18 retary may only grant a waiver under paragraph (1) 

19 to a facility, if such facility— 

20 (A) demonstrates that it is not techno21 logically feasible to— 

22 (i) replace bisphenol A in the certain 

23 type of container or containers for such 

24 particular food product or products; or 


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1 (ii) use an alternative container that 

2 does not contain bisphenol A for such par3 ticular food product or products; and 

4 (B) submits to the Secretary a plan and 

5 timeline for removing bisphenol A from such 

6 type of container or containers for that food 

7 product or products. 

8 (4) LABELING.— 

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

10 the Secretary grants such a waiver shall display 

11 a prominent warning on the label that the con12 tainer contains bisphenol A, in a manner that 

13 the Secretary shall require. 

14 (B) ADDITIONAL REQUIREMENT.—The 

15 prominent warning required under subpara16 graph (A) shall include information to ensure 

17 adequate public awareness of potential health 

18 effects associated with bisphenol A. 

19 (5) DURATION.— 

20 (A) INITIAL WAIVER.—Any waiver granted 

21 under paragraph (1) to a facility for a food con22 tainer or containers shall be valid for not longer 

23 than 1 year after the date on which subsection 

24 (a) is applicable to such food container or con25 tainers. 


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1 (B) RENEWAL OF WAIVER.—The Secretary 

2 may renew any waiver granted under paragraph 

3 (1) for periods of not more than 1 year, pro4 vided that the Secretary reaffirms that it is not 

5 technologically feasible to replace bisphenol A in 

6 such type of container or containers for such 

7 particular food product or products or use an 

8 alternative container that does not contain 

9 bisphenol A for such particular food product or 

10 products. 

11 (c) REEXAMINATION OF APPROVED FOOD ADDI12 TIVES, EFFECTIVE FOOD CONTACT SUBSTANCE NOTIFI13 CATIONS, AND SUBSTANCES THAT ARE GENERALLY REC14 OGNIZED AS SAFE.— 

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

16 year after enactment of this Act, after opportunity 

17 for comment, the Secretary, acting through the 

18 Commissioner of Food and Drugs shall publish a 

19 plan and schedule for the selection of substances 

20 under paragraph (2) and the review of substances 

21 under paragraph (5). 

22 (2) SELECTION OF SUBSTANCES.—Not later 

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

24 than once every 3 years thereafter, the Secretary, 

25 acting through the Commissioner of Food and 


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1 Drugs, shall, based on the factors under paragraph 

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

3 Such selection shall be made from among— 

4 (A) substances authorized as a food addi5 tive under any regulations issued under section 

6 409 of the Federal Food, Drug, and Cosmetic 

7 Act; 

8 (B) substances that are the subject of any 

9 sanction or approval as described in section 

10 201(s)(4) of the Federal Food, Drug, and Cos11 metic Act; 

12 (C) substances that are the subject of an 

13 effective food contact substance notification, as 

14 described in section 409(h) of the Federal 

15 Food, Drug, and Cosmetic Act; 

16 (D) substances that are generally recog17 nized as safe, as listed in part 182 of title 21, 

18 Code of Federal Regulations (or any successor 

19 regulations); 

20 (E) direct food substances affirmed as gen21 erally recognized as safe, as listed in part 184 

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

23 successor regulations); and 

24 (F) indirect food substances affirmed as 

25 generally recognized as safe, as listed in part 


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1 186 of title 21, Code of Federal Regulations (or 

2 any successor regulations). 

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

4 substances under paragraph (2) shall be subject to 

5 notice and comment. 

6 (4) PRIORITIES.—In selecting substances under 

7 paragraph (2), the Secretary shall take into consid8 eration the following factors: 

9 (A) Whether, based on new scientific infor10 mation, the Secretary determines that there is 

11 a possibility that there is no longer a reasonable 

12 certainty that no harm will result from aggre13 gate exposure to such substance through food 

14 containers composed, in whole or in part, of 

15 such substance, taking into consideration— 

16 (i) potential adverse effects from low 

17 dose exposure; and 

18 (ii) the effects of exposure on vulner19 able populations, including pregnant 

20 women, infants, children, the elderly, and 

21 populations with high exposure to such 

22 substance. 

23 (B) Whether, since the introduction of 

24 such substance into interstate commerce, there 


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1 has been a significant increase in the amount of 

2 such substance found in— 

3 (i) sources of drinking water; or 

4 (ii) products that are likely to be used 

5 by vulnerable populations, including preg6 nant women, infants, children, the elderly, 

7 and populations with high exposure to such 

8 substance. 

9 (5) REVIEW OF SUBSTANCES AND SECRETARIAL

10 DETERMINATION.— 

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

12 after the date on which a substance is selected 

13 under paragraph (2), the Secretary shall deter14 mine whether there is a reasonable certainty 

15 that no harm will result from aggregate expo16 sure to such substance, taking into consider17 ation— 

18 (i) potential adverse effects from low 

19 dose exposure; and 

20 (ii) the effects of exposure on vulner21 able populations, including pregnant 

22 women, infants, children, the elderly, and 

23 populations with high exposure to such 

24 substance. 


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1 (B) NOTICE AND COMMENT.—The deter2 mination made under subparagraph (A) shall be 

3 subject to notice and comment. 

4 (6) REMEDIAL ACTION.— 

5 (A) IN GENERAL.—Upon a determination 

6 under paragraph (5) that there is not a reason7 able certainty that no harm will result from ag8 gregate exposure to a substance through food 

9 containers composed, in whole or in part, of 

10 such substance— 

11 (i) if the substance is not defined as 

12 a food contact substance under the Federal 

13 Food, Drug, and Cosmetic Act, the sub14 stance shall be subject to sections 

15 409(a)(3) and 409(h) of the Federal Food, 

16 Drug, and Cosmetic Act, subject to the 

17 process under subparagraph (B); and 

18 (ii) if the substance is defined as a 

19 food contact substance under the Federal 

20 Food, Drug, and Cosmetic Act, the sub21 stance shall be subject to subparagraph 

22 (C). 

23 (B) TREATMENT OF SUBSTANCES THAT

24 ARE NOT DEFINED AS FOOD CONTACT SUBVerDate Mar 15 2010 03:42 Jun 06, 2013 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2248.IH H2248

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1 STANCES.—The process under this subpara2 graph is as follows: 

3 (i) One year after the determination 

4 under paragraph (5) for a substance sub5 ject to the process under this subpara6 graph— 

7 (I) any regulation issued under 

8 section 409 of the Federal Food, 

9 Drug, and Cosmetic Act that author10 izes any use of the substance as a 

11 food additive (including sections 

12 177.1580, 177.1440, 177.2280, and 

13 175.300(b)(3)(viii) of title 21, Code of 

14 Federal Regulations, as in effect on 

15 the date of enactment of this Act); 

16 and 

17 (II) any sanction or approval as 

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

19 Act regarding such substance, 

20 shall be deemed revoked. 

21 (ii) Upon receipt of a food contact no22 tification for a food contact substance con23 taining a substance subject to the process 

24 under this subparagraph, the Secretary 

25 shall review the notification under the auVerDate Mar 15 2010 03:42 Jun 06, 2013 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2248.IH H2248

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1 thority described in sections 409(a)(3) and 

2 409(h) of the Federal Food, Drug, and 

3 Cosmetic Act. 

4 (C) TREATMENT OF SUBSTANCES DEFINED

5 AS FOOD CONTACT SUBSTANCES.— 

6 (i) One year after the determination 

7 under paragraph (5) for a substance that 

8 is subject to this subparagraph, all effec9 tive notifications for the use of such sub10 stance under the authority described in 

11 sections 409(a)(3) and 409(h) of the Fed12 eral Food, Drug, and Cosmetic Act shall 

13 be reviewed by the Secretary. 

14 (ii) Upon receipt of a food contact no15 tification for a food contact substance con16 taining a substance that is subject to this 

17 subparagraph, the Secretary shall review 

18 the notification under the authority de19 scribed in sections 409(a)(3) and 409(h) of 

20 the Federal Food, Drug, and Cosmetic 

21 Act. 

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

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

24 or Indian tribe to adopt or enforce any regulation, require25 ment, liability, or standard of performance that is more 


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1 stringent than a regulation, requirement, liability, or 

2 standard of performance under this Act or that— 

3 (1) applies to a product category not described 

4 in this Act; or 

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

6 illness, or injury associated with the use of food con7 tainers composed, in whole or in part, of bisphenol 

8 A. 

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

10 (1) REUSABLE FOOD CONTAINER.—The term 

11 ‘‘reusable food container’’ means a reusable food 

12 container that does not contain a food item when it 

13 is introduced or delivered for introduction into inter14 state commerce. 

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

16 the Secretary of Health and Human Services. 

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

18 FOOD, DRUG, AND COSMETIC ACT. 

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

20 Drug, and Cosmetic Act (21 U.S.C. 348(h)(1)) is amend21 ed— 

22 (1) in paragraph (1)— 

23 (A) by striking ‘‘manufacturer or supplier 

24 for a food contact substance may’’ and insertVerDate Mar 15 2010 03:42 Jun 06, 2013 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2248.IH H2248

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1 ing ‘‘manufacturer or supplier for a food con2 tact substance shall’’; 

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

4 Secretary of’’; 

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

6 (B)’’; and 

7 (D) by striking the period after ‘‘sub8 section (c)(3)(A)’’ and inserting ‘‘; (C) the de9 termination of the manufacturer or supplier 

10 that no adverse health effects result from low11 dose exposures to the food contact substance; 

12 and (D) the determination of the manufacturer 

13 or supplier that the substance has not been 

14 shown, after tests which are appropriate for the 

15 evaluation of the safety of food contact sub16 stances, to cause reproductive or developmental 

17 toxicity in humans or animals.’’; and 

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

19 following: 

20 ‘‘(6) In this section— 

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

22 any substance intended for use as a component of 

23 materials used in manufacturing, packing, pack24 aging, transporting, or holding food if such use is 


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1 not intended to have any technical effect in such 

2 food; and 

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

4 toxicity’ means biologically adverse effects on the re5 productive systems of female or male humans or ani6 mals, including alterations to the female or male re7 productive system development, the related endo8 crine system, fertility, pregnancy, pregnancy out9 comes, or modifications in other functions that are 

10 dependent on the integrity of the reproductive sys11 tem.’’. 

12 SEC. 4. REPORT TO CONGRESS. 

13 No later than two years after enactment of this Act 

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

15 the Secretary shall submit a report to the Committee on 

16 Energy and Commerce of the House of Representatives. 

17 Such report shall include— 

18 (1) a list of waivers granted under section 

19 2(b)(1), including a description of the basis each 

20 such waiver; 

21 (2) a list of substances selected for review 

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

23 for future selections of additional substances; 


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1 (3) for each substance reviewed under section 

2 2(c)(5), the outcome of such review, and the antici3 pated timeline for review of additional substances; 

4 (4) a description of all remedial action taken 

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

6 (5) for bisphenol A and any other substance de7 termined not to have a reasonable certainty of no 

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

9 alternatives to that substance that are available or 

10 being developed for use in food and beverage con11 tainers. 

Æ 


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