HR 432 IHCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

H. R. 432CommentsClose CommentsPermalink

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

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

January 25, 2011CommentsClose CommentsPermalink

Mr. MARKEY (for himself, Ms. SLAUGHTER, Ms. SCHAKOWSKY, and Mr. MORAN) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

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

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Ban Poisonous Additives Act of 2011’.CommentsClose CommentsPermalink

SEC. 2. BAN ON USE OF BISPHENOL A IN FOOD AND BEVERAGE CONTAINERS.

(a) Treatment of Bisphenol A as Adulterating the Food or Beverage-CommentsClose CommentsPermalink





(1) IN GENERAL- For purposes of applying section 402(a)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(6)), a food container (which for purposes of this Act includes a beverage container) that is composed, in whole or in part, of bisphenol A, or that can release bisphenol A into food (as defined for purposes of the Federal Food, Drug, and Cosmetic Act), shall be treated as a container described in such section (relating to containers composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health).CommentsClose CommentsPermalink





(2) APPLICABILITY-CommentsClose CommentsPermalink





(A) REUSABLE FOOD CONTAINERS- Paragraph (1) shall apply to reusable food containers on the date that is 180 days after the date of enactment of this Act.CommentsClose CommentsPermalink





(B) OTHER FOOD CONTAINERS- Paragraph (1) shall apply to any food container that is packed with food and is introduced or delivered for introduction into interstate commerce on or after the date that is 180 days after the date of enactment of this Act.CommentsClose CommentsPermalink





(b) Waiver-CommentsClose CommentsPermalink





(1) IN GENERAL- The Secretary, after public notice and opportunity for comment, may grant to any facility (as that term is defined in section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d)) that manufactures, processes, packs, holds, or sells the particular food product or products, a waiver of the treatment described in subsection (a).CommentsClose CommentsPermalink





(2) APPLICABILITY- A waiver granted to a facility under paragraph (1) may only be applicable to a certain type of food container or containers, as used for a particular food product or group of similar products containing similar foods.CommentsClose CommentsPermalink





(3) REQUIREMENT FOR WAIVER- The Secretary may only grant a waiver under paragraph (1) to a facility, if such facility--CommentsClose CommentsPermalink





(A) demonstrates that it is not technologically feasible to--CommentsClose CommentsPermalink





(i) replace bisphenol A in the certain type of container or containers for such particular food product or products; orCommentsClose CommentsPermalink





(ii) use an alternative container that does not contain bisphenol A for such particular food product or products; andCommentsClose CommentsPermalink





(B) submits to the Secretary a plan and timeline for removing bisphenol A from such type of container or containers for that food product or products.CommentsClose CommentsPermalink





(4) LABELING-CommentsClose CommentsPermalink





(A) IN GENERAL- Any product for which the Secretary grants such a waiver shall display a prominent warning on the label that the container contains bisphenol A, in a manner that the Secretary shall require.CommentsClose CommentsPermalink





(B) ADDITIONAL REQUIREMENT- The prominent warning required under subparagraph (A) shall include information to ensure adequate public awareness of potential health effects associated with bisphenol A.CommentsClose CommentsPermalink





(5) DURATION-CommentsClose CommentsPermalink





(A) INITIAL WAIVER- Any waiver granted under paragraph (1) to a facility for a food container or containers shall be valid for not longer than 1 year after the date on which subsection (a) is applicable to such food container or containers.CommentsClose CommentsPermalink





(B) RENEWAL OF WAIVER- The Secretary may renew any waiver granted under paragraph (1) for periods of not more than 1 year, provided that the Secretary reaffirms that it is not technologically feasible to replace bisphenol A in such type of container or containers for such particular food product or products or use an alternative container that does not contain bisphenol A for such particular food product or products.CommentsClose CommentsPermalink





(c) Reexamination of Approved Food Additives, Effective Food Contact Substance Notifications, and Substances That Are Generally Recognized as Safe-CommentsClose CommentsPermalink





(1) PLAN AND SCHEDULE- Not later than 1 year after enactment of this Act, after opportunity for comment, the Secretary, acting through the Commissioner of Food and Drugs shall publish a plan and schedule for the selection of substances under paragraph (2) and the review of substances under paragraph (5).CommentsClose CommentsPermalink





(2) SELECTION OF SUBSTANCES- Not later than 1 year after enactment of this Act and not less than once every 3 years thereafter, the Secretary, acting through the Commissioner of Food and Drugs, shall, based on the factors under paragraph (4), select substances to review under paragraph (5). Such selection shall be made from among--CommentsClose CommentsPermalink





(A) substances authorized as a food additive under any regulations issued under section 409 of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink





(B) substances that are the subject of any sanction or approval as described in section 201(s)(4) of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink





(C) substances that are the subject of an effective food contact substance notification, as described in section 409(h) of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink





(D) substances that are generally recognized as safe, as listed in part 182 of title 21, Code of Federal Regulations (or any successor regulations);CommentsClose CommentsPermalink





(E) direct food substances affirmed as generally recognized as safe, as listed in part 184 of title 21, Code of Federal Regulations (or any successor regulations); andCommentsClose CommentsPermalink





(F) indirect food substances affirmed as generally recognized as safe, as listed in part 186 of title 21, Code of Federal Regulations (or any successor regulations).CommentsClose CommentsPermalink





(3) NOTICE AND COMMENT- The selection of substances under paragraph (2) shall be subject to notice and comment.CommentsClose CommentsPermalink





(4) PRIORITIES- In selecting substances under paragraph (2), the Secretary shall take into consideration the following factors:CommentsClose CommentsPermalink





(A) Whether, based on new scientific information, the Secretary determines that there is a possibility that there is no longer a reasonable certainty that no harm will result from aggregate exposure to such substance through food containers composed, in whole or in part, of such substance, taking into consideration--CommentsClose CommentsPermalink





(i) potential adverse effects from low dose exposure; andCommentsClose CommentsPermalink





(ii) the effects of exposure on vulnerable populations, including pregnant women, infants, children, the elderly, and populations with high exposure to such substance.CommentsClose CommentsPermalink





(B) Whether, since the introduction of such substance into interstate commerce, there has been a significant increase in the amount of such substance found in--CommentsClose CommentsPermalink





(i) sources of drinking water; orCommentsClose CommentsPermalink





(ii) products that are likely to be used by vulnerable populations, including pregnant women, infants, children, the elderly, and populations with high exposure to such substance.CommentsClose CommentsPermalink





(5) REVIEW OF SUBSTANCES AND SECRETARIAL DETERMINATION-CommentsClose CommentsPermalink





(A) IN GENERAL- No later than 1 year after the date on which a substance is selected under paragraph (2), the Secretary shall determine whether there is a reasonable certainty that no harm will result from aggregate exposure to such substance, taking into consideration--CommentsClose CommentsPermalink





(i) potential adverse effects from low dose exposure; andCommentsClose CommentsPermalink





(ii) the effects of exposure on vulnerable populations, including pregnant women, infants, children, the elderly, and populations with high exposure to such substance.CommentsClose CommentsPermalink





(B) NOTICE AND COMMENT- The determination made under subparagraph (A) shall be subject to notice and comment.CommentsClose CommentsPermalink





(6) REMEDIAL ACTION-CommentsClose CommentsPermalink





(A) IN GENERAL- Upon a determination under paragraph (5) that there is not a reasonable certainty that no harm will result from aggregate exposure to a substance through food containers composed, in whole or in part, of such substance--CommentsClose CommentsPermalink





(i) if the substance is not defined as a food contact substance under the Federal Food, Drug, and Cosmetic Act, the substance shall be subject to sections 409(a)(3) and 409(h) of the Federal Food, Drug, and Cosmetic Act, subject to the process under subparagraph (B); andCommentsClose CommentsPermalink





(ii) if the substance is defined as a food contact substance under the Federal Food, Drug, and Cosmetic Act, the substance shall be subject to subparagraph (C).CommentsClose CommentsPermalink





(B) TREATMENT OF SUBSTANCES THAT ARE NOT DEFINED AS FOOD CONTACT SUBSTANCES- The process under this subparagraph is as follows:CommentsClose CommentsPermalink





(i) One year after the determination under paragraph (5) for a substance subject to the process under this subparagraph--CommentsClose CommentsPermalink





(I) any regulation issued under section 409 of the Federal Food, Drug, and Cosmetic Act that authorizes any use of the substance as a food additive (including sections 177.1580, 177.1440, 177.2280, and 175.300(b)(3)(viii) of title 21, Code of Federal Regulations, as in effect on the date of enactment of this Act); andCommentsClose CommentsPermalink





(II) any sanction or approval as described in section 201(s)(4) of such Act regarding such substance,CommentsClose CommentsPermalink





shall be deemed revoked.CommentsClose CommentsPermalink





(ii) Upon receipt of a food contact notification for a food contact substance containing a substance subject to the process under this subparagraph, the Secretary shall review the notification under the authority described in sections 409(a)(3) and 409(h) of the Federal Food, Drug, and Cosmetic Act.CommentsClose CommentsPermalink





(C) TREATMENT OF SUBSTANCES DEFINED AS FOOD CONTACT SUBSTANCES-CommentsClose CommentsPermalink





(i) One year after the determination under paragraph (5) for a substance that is subject to this subparagraph, all effective notifications for the use of such substance under the authority described in sections 409(a)(3) and 409(h) of the Federal Food, Drug, and Cosmetic Act shall be reviewed by the Secretary.CommentsClose CommentsPermalink





(ii) Upon receipt of a food contact notification for a food contact substance containing a substance that is subject to this subparagraph, the Secretary shall review the notification under the authority described in sections 409(a)(3) and 409(h) of the Federal Food, Drug, and Cosmetic Act.CommentsClose CommentsPermalink





(d) Savings Provision- Nothing in this Act shall affect the right of a State, political subdivision of a State, or Indian tribe to adopt or enforce any regulation, requirement, liability, or standard of performance that is more stringent than a regulation, requirement, liability, or standard of performance under this Act or that--CommentsClose CommentsPermalink





(1) applies to a product category not described in this Act; orCommentsClose CommentsPermalink





(2) requires the provision of a warning of risk, illness, or injury associated with the use of food containers composed, in whole or in part, of bisphenol A.CommentsClose CommentsPermalink





(e) Definitions- For purposes of this section:CommentsClose CommentsPermalink





(1) REUSABLE FOOD CONTAINER- The term ‘reusable food container’ means a reusable food container that does not contain a food item when it is introduced or delivered for introduction into interstate commerce.CommentsClose CommentsPermalink





(2) SECRETARY- The term ‘Secretary’ means the Secretary of Health and Human Services.CommentsClose CommentsPermalink

SEC. 3. AMENDMENTS TO SECTION 409 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

Subsection (h) of section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(h)(1)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (1)--CommentsClose CommentsPermalink





(A) by striking ‘manufacturer or supplier for a food contact substance may’ and inserting ‘manufacturer or supplier for a food contact substance shall’;CommentsClose CommentsPermalink





(B) by inserting ‘(A)’ after ‘notify the Secretary of’;CommentsClose CommentsPermalink





(C) by striking ‘, and of’ and inserting ‘; (B)’; andCommentsClose CommentsPermalink





(D) by striking the period after ‘subsection (c)(3)(A)’ and inserting ‘; (C) the determination of the manufacturer or supplier that no adverse health effects result from low-dose exposures to the food contact substance; and (D) the determination of the manufacturer or supplier that the substance has not been shown, after tests which are appropriate for the evaluation of the safety of food contact substances, to cause reproductive or developmental toxicity in humans or animals.’; andCommentsClose CommentsPermalink





(2) by striking paragraph (6) and inserting the following:CommentsClose CommentsPermalink





‘(6) In this section--CommentsClose CommentsPermalink





‘(A) the term ‘food contact substance’ means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food; andCommentsClose CommentsPermalink





‘(B) the term ‘reproductive or developmental toxicity’ means biologically adverse effects on the reproductive systems of female or male humans or animals, including alterations to the female or male reproductive system development, the related endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions that are dependent on the integrity of the reproductive system.’.CommentsClose CommentsPermalink

SEC. 4. REPORT TO CONGRESS.

No later than two years after enactment of this Act and at least once during every two year period thereafter, the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives. Such report shall include--CommentsClose CommentsPermalink





(1) a list of waivers granted under section 2(b)(1), including a description of the basis each such waiver;CommentsClose CommentsPermalink





(2) a list of substances selected for review under section 2(c)(2) and the anticipated timeline for future selections of additional substances;CommentsClose CommentsPermalink





(3) for each substance reviewed under section 2(c)(5), the outcome of such review, and the anticipated timeline for review of additional substances;CommentsClose CommentsPermalink





(4) a description of all remedial action taken under section 2(c)(6); andCommentsClose CommentsPermalink





(5) for bisphenol A and any other substance determined not to have a reasonable certainty of no harm under section 2(c)(5), a review of the potential alternatives to that substance that are available or being developed for use in food and beverage containers.CommentsClose CommentsPermalink