Ban Poisonous Additives Act of 2016

To ban the use of bisphenol A in food containers and the replacement of bisphenol A in such containers with unsafe alternatives, and for other purposes. 1. Short title This Act may be cited as the Ban Poisonous Additives Act of 2016 2. Ban on use of bisphenol A in food and beverage containers (a) Treatment of bisphenol A as adulterating the food or beverage (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) (2) Applicability (A) Reusable food containers Paragraph (1) (B) Other food containers Paragraph (1) (b) Waiver (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 subsection (a) (2) Applicability A waiver granted to a facility under paragraph (1) (3) Requirement for waiver The Secretary may only grant a waiver under paragraph (1) (A) demonstrates that it is not technologically feasible to— (i) replace bisphenol A in the certain type of container or containers for such particular food product or products; or (ii) use an alternative container that does not contain bisphenol A for such particular food product or products; and (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. (4) Labeling (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 that states, bisphenol A (BPA) is a chemical that can leach into food and may harm prenatal development and the health of children and adults (B) Additional requirement The prominent warning required under subparagraph (A) (5) Duration (A) Initial waiver Any waiver granted under paragraph (1) subsection (a) (B) Renewal of waiver The Secretary may renew any waiver granted under paragraph (1) (c) Substances used To replace Bisphenol A The Secretary shall, to the extent possible, promote, facilitate, and incentivize the use of safer alternatives to replace bisphenol A, and as such bisphenol A shall not be replaced in food containers with substances that— (1) are known or are likely human carcinogens; (2) have been found by the Environmental Protection Agency to be persistent, bioaccumulative, and toxic; (3) cause reproductive or developmental toxicity; or (4) are endocrine disrupting chemicals. (d) Reexamination of approved food additives, effective food contact substance notifications, and substances that are generally recognized as safe (1) Plan and schedule Not later than 1 year after the date of 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) paragraph (5) (2) Selection of substances Not later than 1 year after the date of 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) paragraph (5) (A) substances authorized as a food additive under any regulations issued under section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348 (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 ( 21 U.S.C. 321(s)(4) (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 ( 21 U.S.C. 348(h) (D) substances that are generally recognized as safe, as listed in part 182 of title 21, Code of Federal Regulations (or any successor regulations); (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); and (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). (3) Notice and comment The selection of substances under paragraph (2) (4) Priorities In selecting substances under paragraph (2) (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— (i) potential adverse effects from low dose exposure; and (ii) the effects of exposure on vulnerable human populations. (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— (i) sources of drinking water; or (ii) products that are likely to be used by vulnerable human populations. (C) Whether such substance has been approved by the Food and Drug Administration to be used in the lining of canned food. (5) Review of substances and Secretarial determination (A) In general Not later than 1 year after the date on which a substance is selected under paragraph (2) (i) potential adverse effects from low dose exposure; and (ii) the effects of exposure on vulnerable human populations. (B) Notice and comment The determination made under subparagraph (A) (6) Remedial action (A) In general Upon a determination under paragraph (5) (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 subsections (a)(3) and (h) of section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(a)(3) subparagraph (B) (ii) if the substance is defined as a food contact substance under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. subparagraph (C); and (iii) the Secretary shall, to the extent practicable, promote, facilitate, and incentivize the use of safer alternatives as replacements for such substance. (B) Treatment of substances that are not defined as food contact substances The process under this subparagraph is as follows: (i) One year after the determination under paragraph (5) (I) any regulation issued under section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348 (II) any sanction or approval as described in section 201(s)(4) of such Act ( 21 U.S.C. 321(s)(4) shall be deemed revoked. (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 subsections (a)(3) and (h) of section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(a)(3) (C) Treatment of substances defined as food contact substances (i) One year after the determination under paragraph (5) 21 U.S.C. 348(a)(3) (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 subsections (a)(3) and (h) of section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(a)(3) (e) 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— (1) applies to a product category not described in this Act; or (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. (f) Definitions For purposes of this section: (1) Endocrine disrupting chemical The term endocrine disrupting chemical (2) Reusable food container The term reusable food container (3) Safer alternative The term safer alternative (A) chemical or process substitution; (B) chemical or process re-formulation or re-design; and (C) chemical or process elimination or phase-out. (4) Secretary The term Secretary (5) Vulnerable human population The term vulnerable human population (A) infants, children, and adolescents; (B) pregnant women; (C) the elderly; (D) individuals with preexisting medical conditions; (E) workers who may be exposed to chemical substances and mixtures; (F) residents in communities subject to disproportionate exposures; and (G) members of any other appropriate population identified by the Secretary. 3. Amendments to section 409 of the Federal Food, Drug, and Cosmetic Act Section 409(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(h) (1) in paragraph (1)— (A) by striking manufacturer or supplier of a food contact substance may manufacturer or supplier of a food contact substance shall (B) by inserting (A) notify the Secretary of (C) by striking , and of ; (B) (D) by striking the period after subsection (c)(3)(A) ; (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. (2) by striking paragraph (6) and inserting the following: (6) In this section— (A) the term food contact substance (B) the term reproductive or developmental toxicity . 4. Report to Congress Not later than 2 years after the date of enactment of this Act and at least once during every 2-year period thereafter, the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. Such report shall include— (1) a list of waivers granted under section 2(b)(1), including a description of the basis for each such waiver; (2) a list of substances selected for review under section 2(c)(2) and the anticipated timeline for future selections of additional substances; (3) for each substance reviewed under section 2(c)(5), the outcome of such review, and the anticipated timeline for review of additional substances; (4) a description of all remedial action taken under section 2(c)(6); and (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.

Summary: Ban Poisonous Additives Act of 2016 This bill bans food containers composed, in whole or in part, of bisphenol A (BPA). The Food and Drug Administration (FDA) may grant waivers to a facility for a particular product if the facility: (1) demonstrates that it is not technologically feasible to replace BPA in the container or to use a BPA-free container, and (2) submits to the FDA a plan and time line for removing BPA from the container. Products granted a waiver must include a warning on the label. The FDA must promote and facilitate the use of BPA replacements. BPA may not be replaced with substances that: (1) are known or likely human carcinogens; (2) have been found by the Environmental Protection Agency (EPA) to be persistent, bioaccumulative, and toxic; (3) cause reproductive or developmental toxicity; or (4) are endocrine disrupting chemicals. The FDA must review substances that may be found in food, including food additives and food contact substances, and take remedial action if it does not determine that there is a reasonable certainty that no harm will result from aggregate exposure, taking into consideration potential adverse effects from low-dose exposure and the effects on vulnerable populations and populations with high exposure. This bill amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer or supplier of a food contact substance to notify the FDA of the identity and intended use of the substance prior to its introduction into interstate commerce and that: (1) no adverse health effects result from low-dose exposures to the substance, and (2) the substance has not been shown to cause reproductive or developmental toxicity in humans or animals.