[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3412 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Ban Poisonous Additives Act of 
2016''.

SEC. 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)), 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).
            (2) Applicability.--
                    (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.
                    (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.
    (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)) that manufactures, processes, 
        packs, holds, or sells the particular food product or products, 
        a waiver of the treatment described in subsection (a).
            (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.
            (3) Requirement for waiver.--The Secretary may only grant a 
        waiver under paragraph (1) to a facility, if such facility--
                    (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) shall include 
                information to ensure adequate public awareness of 
                potential health effects associated with bisphenol A.
            (5) Duration.--
                    (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.
                    (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.
    (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) and the review of substances 
        under 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), select substances to review under 
        paragraph (5). Such selection shall be made from among--
                    (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) shall be subject to notice and comment.
            (4) Priorities.--In selecting substances under paragraph 
        (2), the Secretary shall take into consideration the following 
        factors:
                    (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), the Secretary shall determine whether there is a 
                reasonable certainty that no harm will result from 
                aggregate exposure to such substance, taking into 
                consideration--
                            (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) shall be subject to notice and 
                comment.
            (6) Remedial action.--
                    (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--
                            (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) and (h)), 
                        subject to the process under 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.), the 
                        substance shall be subject to 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) for a substance subject to the 
                        process under this subparagraph--
                                    (I) any regulation issued under 
                                section 409 of the Federal Food, Drug, 
                                and Cosmetic Act (21 U.S.C. 348) 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); and
                                    (II) any sanction or approval as 
                                described in section 201(s)(4) of such 
                                Act (21 U.S.C. 321(s)(4)) regarding 
                                such substance,
                        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) and (h)).
                    (C) Treatment of substances defined as food contact 
                substances.--
                            (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 subsections 
                        (a)(3) and (h) of section 409 of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 
                        348(a)(3) and (h)) shall be reviewed by the 
                        Secretary.
                            (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) and (h)).
    (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'' means an exogenous agent that causes 
        adverse effects, such as by interfering with the production, 
        release, transport, metabolism, binding, action, or elimination 
        of the natural hormones in the body responsible for the 
        maintenance of homeostasis and the regulation of developmental 
        processes.
            (2) 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.
            (3) Safer alternative.--The term ``safer alternative'' 
        means an option, that is safer for humans and the environment 
        than the existing chemical or process, including--
                    (A) chemical or process substitution;
                    (B) chemical or process reformulation or redesign; 
                and
                    (C) chemical or process elimination or phase-out.
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (5) Vulnerable human population.--The term ``vulnerable 
        human population'' means a human population that is subject to 
        the potential for disproportionate exposure to, or the 
        potential for disproportionate adverse effect from exposure to, 
        a chemical substance or mixture, including--
                    (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.

SEC. 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)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``manufacturer or supplier of a 
                food contact substance may'' and inserting 
                ``manufacturer or supplier of a food contact substance 
                shall'';
                    (B) by inserting ``(A)'' after ``notify the 
                Secretary of'';
                    (C) by striking ``, and of'' and inserting ``; 
                (B)''; and
                    (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.''; and
            (2) by striking paragraph (6) and inserting the following:
    ``(6) In this section--
            ``(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; and
            ``(B) the term `reproductive or developmental toxicity' 
        means biologically adverse effects on the reproductive systems 
        of female or male humans or animals, or on developing organisms 
        that may result from exposure prior to conception, during 
        prenatal development, or until the time of sexual maturation, 
        that may include female or male reproductive system 
        development, fertility, pregnancy, pregnancy outcomes, or 
        modifications in other functions that are dependent on the 
        integrity of the reproductive system or effects on the 
        developing organism, including death, structural abnormality, 
        altered growth, or functional deficiency.''.

SEC. 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.
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