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<dc:title>117 S2669 IS: Preventing Harmful Exposure to Phthalates Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-08-05</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 2669</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210805">August 5, 2021</action-date><action-desc><sponsor name-id="S221">Mrs. Feinstein</sponsor> (for herself and <cosponsor name-id="S331">Mrs. Gillibrand</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To ban the use of ortho-phthalate chemicals as food contact substances.</official-title></form><legis-body display-enacting-clause="yes-display-enacting-clause"><section section-type="section-one" id="S1"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Preventing Harmful Exposure to Phthalates Act</short-title></quote>.</text></section><section id="id161D3C20A3E242C7924383891B35F931"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds as follows: </text><paragraph id="id2421c71bd8044275a1c669f616fa6cd5"><enum>(1)</enum><text>Prenatal exposures to phthalates can do lasting harm to child brain development and increase children's risks for learning, attention, and behavior disorders.</text></paragraph><paragraph id="idC440982E42064AF7AFCDCC00C1144A68"><enum>(2)</enum><text>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. </text></paragraph><paragraph id="id26497b34b9cd44fcb13db4731e487335"><enum>(3)</enum><text>Phthalates that are used in food production materials have been shown to leach into food from plastic equipment, such as tubing used in commercial dairy operations, lid gaskets, food preparation gloves, conveyor belts, and food packaging materials. </text></paragraph><paragraph id="id9CFD97EDD2524DE2B7384DE325DE474E"><enum>(4)</enum><text>Exposure to phthalates can come from multiple sources simultaneously, including food and food contact substances and other products. Therefore, assessing risks from individual phthalates may underestimate the health risks from exposure to mixtures of phthalates.</text></paragraph><paragraph id="id9A8E4600B9794F6B8968E33458F0414B"><enum>(5)</enum><text>Research shows that women have higher exposure to phthalates found in personal care products than men.</text></paragraph><paragraph id="idF7AD21007466463C9373222CF8ECF32E"><enum>(6)</enum><text>Studies have shown that Black and Latina women have higher exposure to certain phthalates compared with White women.</text></paragraph><paragraph id="idF6B2CB14814047FFA72C9CAA5A49FB3C"><enum>(7)</enum><text>In a nationally representative sample, Black women had higher exposures to a real-world mixture of hormonally-active phthalates compared to White women. </text></paragraph></section><section id="id0DF446ACE6FF45D1A2FA622BAAE75F18"><enum>3.</enum><header>Prohibition on use of ortho-phthalate chemicals as food contact substances, including food packaging materials</header><subsection id="idF675DFF29ED34A9885DE938DFD793354"><enum>(a)</enum><header>In general</header><text>Notwithstanding any other provision of law, effective on the date that is 2 years after the date of enactment of this Act—</text><paragraph id="id4B10D55885C84EE8952B1B0281618EAB"><enum>(1)</enum><text>the use of any ortho-phthalate chemical as a food contact substance shall be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 402(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/342">21 U.S.C. 342(a)</external-xref>);</text></paragraph><paragraph id="idD4D0760446BF4A89AB729F2505F8D190"><enum>(2)</enum><text>any regulation previously issued under section 409 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/348">21 U.S.C. 348</external-xref>) prescribing the conditions under which any ortho-phthalate chemical may be safely used as a food contact substance shall have no force or effect; and</text></paragraph><paragraph id="id37C1A6E8A3484E66A875614598AA390F"><enum>(3)</enum><text>the Secretary of Health and Human Services (referred to in this Act as the <quote>Secretary</quote>) 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.</text></paragraph></subsection><subsection id="id006CFEE7B9F440EFB901755684B3B9D2"><enum>(b)</enum><header>Alternative substances</header><text>Notwithstanding any other provision of law, beginning on the date that is 2 years after the date of enactment of this Act, in acting in response to any petition under section 409 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/348">21 U.S.C. 348</external-xref>) 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 consider potential adverse effects of exposure to the substance on vulnerable populations, including pregnant women, infants, children, the elderly, and populations with high exposure, including workers who are exposed through production practices or handling of final products.</text></subsection></section><section id="idE743A0BE354D44A696D133A6DD8A1482"><enum>4.</enum><header>FDA review of products</header><subsection id="idEC2CF31D41E64B6082EED5B5FEF1DE30"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall—</text><paragraph id="id69371EBAFC96477DA98A718FA6976F93"><enum>(1)</enum><text display-inline="yes-display-inline">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</text></paragraph><paragraph id="id8D4041244930401CAA20D11CA410CB60"><enum>(2)</enum><text display-inline="yes-display-inline">not later than 1 year after the date of enactment 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.</text></paragraph></subsection><subsection id="idBB97A93B1F214829A061CC5ABBA868D8"><enum>(b)</enum><header>Considerations</header><text display-inline="yes-display-inline">In conducting the review under subsection (a), the Secretary shall consider disproportionate 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.</text></subsection></section></legis-body></bill> 

