(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
SUB-
STANCES.—The process under this subpara-
graph is as follows: 
(i) One year after the determination 
under paragraph (5) for a substance sub-
ject to the process under this subpara-
graph— 
(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 (includ-
ing 
sections 
177.1580, 
177.1440, 
177.2280, and 175.300(b)(3)(viii) of 
title 21, Code of Federal Regulations, 
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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 no-
tification for a food contact substance con-
taining a substance subject to the process 
under this subparagraph, the Secretary 
shall review the notification under the au-
thority 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 effec-
tive notifications for the use of such sub-
stance under the authority described in 
subsections (a)(3) and (h) of section 409 
of the Federal Food, Drug, and Cosmetic 
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Act (21 U.S.C. 348(a)(3) and (h)) shall be 
reviewed by the Secretary. 
(ii) Upon receipt of a food contact no-
tification for a food contact substance con-
taining a substance that is subject to this 
subparagraph, the Secretary shall review 
the notification under the authority de-
scribed 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, require-
ment, 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 con-
tainers composed, in whole or in part, of bisphenol 
A. 
(f) DEFINITIONS.—For purposes of this section: 
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(1) ENDOCRINE DISRUPTING CHEMICAL.—The 
term ‘‘endocrine disrupting chemical’’ means an ex-
ogenous agent that causes adverse effects, such as 
by interfering with the production, release, trans-
port, 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 inter-
state commerce. 
(3) SAFER ALTERNATIVE.—The term ‘‘safer al-
ternative’’ 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. 
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(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 chem-
ical substances and mixtures; 
(F) residents in communities subject to 
disproportionate exposures; and 
(G) members of any other appropriate pop-
ulation 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 Cos-
metic 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 
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‘‘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 ‘‘sub-
section (c)(3)(A)’’ and inserting ‘‘; (C) the de-
termination 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 sub-
stances, 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, pack-
aging, transporting, or holding food if such use is 
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not intended to have any technical effect in such 
food; and 
‘‘(B) the term ‘reproductive or developmental 
toxicity’ means biologically adverse effects on the re-
productive systems of female or male humans or ani-
mals, 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 out-
comes, or modifications in other functions that are 
dependent on the integrity of the reproductive sys-
tem 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 Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate. Such report shall in-
clude— 
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(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 antici-
pated 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 de-
termined 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 con-
tainers. 
Æ 
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