I 
117TH CONGRESS 
1ST SESSION H. R. 4963 
To ban the use of ortho-phthalate chemicals as food contact substances. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 6, 2021 
Mr. LIEU (for himself and Ms. PORTER) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
A BILL 
To ban the use of ortho-phthalate chemicals as food contact 
substances. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preventing Harmful 
Exposure to Phthalates Act’’. 
SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) Prenatal exposures to phthalates can do 
lasting harm to child brain development and increase 
children’s risks for learning, attention, and behavior 
disorders. 
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(2) Pregnant women’s exposures to phthalates, 
which are known to decrease fetal testosterone, can 
harm reproductive tract development in male babies 
which may have lifelong consequences. 
(3) Phthalates that are used in food production 
materials have been shown to leach into food from 
plastic equipment, such as tubing used in commer-
cial dairy operations, lid gaskets, food preparation 
gloves, conveyor belts, and food packaging materials. 
(4) Exposure to phthalates can come from mul-
tiple sources simultaneously, including food and food 
contact substances and other products. Therefore, 
assessing risks from individual phthalates may un-
derestimate the health risks from exposure to mix-
tures of phthalates. 
(5) Research shows that women have higher ex-
posure to phthalates found in personal care products 
than men. 
(6) Studies have shown that Black and Latina 
women have higher exposure to certain phthalates 
compared with White women. 
(7) In a nationally representative sample, Black 
women had higher exposures to a real-world mixture 
of hormonally active phthalates compared to White 
women. 
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SEC. 3. PROHIBITION ON USE OF ORTHO-PHTHALATE 
CHEMICALS AS FOOD CONTACT SUBSTANCES, 
INCLUDING FOOD PACKAGING MATERIALS. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, effective on the date that is 2 years after the 
date of enactment of this Act— 
(1) the use of any ortho-phthalate chemical as 
a food contact substance shall be deemed to be un-
safe for the purposes of the application of clause 
(2)(C) of section 402(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 342(a)); 
(2) any regulation previously issued under sec-
tion 409 of such Act (21 U.S.C. 348) prescribing 
the conditions under which any ortho-phthalate 
chemical may be safely used as a food contact sub-
stance shall have no force or effect; and 
(3) the Secretary of Health and Human Serv-
ices (referred to in this Act as the ‘‘Secretary’’) shall 
object to any notification of an intended use of an 
ortho-phthalate chemical as a food contact substance 
submitted under section 409(h)(1) of such Act, and 
may not issue regulations prescribing any conditions 
under which any ortho-phthalate chemical may be 
safely used as a food contact substance. 
(b) ALTERNATIVE SUBSTANCES.—Notwithstanding 
any other provision of law, beginning on the date that is 
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2 years after the date of enactment of this Act, in acting 
in response to any petition under section 409 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 348) to 
establish safety with respect to a food contact substance 
that the Secretary determines to be an alternative to an 
ortho-phthalate chemical, in addition to the criteria under 
subsection (c) of such section 409, the Secretary shall con-
sider potential adverse effects of exposure to the substance 
on vulnerable populations, including pregnant women, in-
fants, children, the elderly, and populations with high ex-
posure, including workers who are exposed through pro-
duction practices or handling of final products. 
SEC. 4. FDA REVIEW OF PRODUCTS. 
(a) IN GENERAL.—The Secretary shall— 
(1) conduct a review of products other than 
food that is subject to regulation by the Food and 
Drug Administration to determine whether such 
products lead to exposure of the general public to 
any ortho-phthalate chemical through use of such 
products; and 
(2) not later than 1 year after the date of en-
actment of this Act, issue a report on the findings 
of such review, to be made available to the public on 
the website of the Department of Health and 
Human Services. 
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(b) CONSIDERATIONS.—In conducting the review 
under subsection (a), the Secretary shall consider dis-
proportionate exposure of products containing an ortho- 
phthalate chemical to members of communities of color 
and the health effects of such exposure to members of 
such communities, including any increased risk of preterm 
birth, low birth weight, or other risks to children’s health. 
Æ 
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