[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2572 Introduced in Senate (IS)]
113th CONGRESS
2d Session
S. 2572
To ban the use of bisphenol A in food containers, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 9, 2014
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
2014''.
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 re-formulation or re-
design; 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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