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<bill bill-stage="Introduced-in-House" dms-id="HEDD4789196CB4EC58DB13098B020D1CA" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>119 HR 8545 IH: Access to Donor Milk Act of 2026</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2026-04-28</dc:date>
<dc:format>text/xml</dc:format>
<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">I</distribution-code><congress display="yes">119th CONGRESS</congress><session display="yes">2d Session</session><legis-num display="yes">H. R. 8545</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20260428">April 28, 2026</action-date><action-desc><sponsor name-id="H001085">Ms. Houlahan</sponsor> (for herself, <cosponsor name-id="B000740">Mrs. Bice</cosponsor>, and <cosponsor name-id="S000168">Ms. Salazar</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committee on <committee-name committee-id="HED00">Education and Workforce</committee-name>, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To protect and expand access to pasteurized, donor human milk, and for other purposes.</official-title></form><legis-body id="H260739CA4EBB4C40B9EC1A46D80545FD" style="OLC"> 
<section section-type="section-one" id="HAFF0A8C45E064088A57193F4CC6DEE73"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Access to Donor Milk Act of 2026</short-title></quote>.</text></section> 
<section id="HDAF460EEF64241879DD75ABBE6E6BE65"><enum>2.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act:</text> <paragraph id="HDD58173E1C6D46A990E13B8E8373BECD"><enum>(1)</enum><header>Donor human milk</header><text>The term <term>donor human milk</term> means human milk that is collected, pasteurized, and dispensed without additives.</text></paragraph> 
<paragraph id="HE9804F16FA86442090F54D0DC55473D3" commented="no"><enum>(2)</enum><header>Donor human milk-derived product</header><text display-inline="yes-display-inline">The term <term>donor human milk-derived product</term> means a product made predominantly from donor human milk—</text> <subparagraph id="H30E03593CEFA4B178E73DCF63D5C92F6" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">from which one or more components has been removed in order to produce a specialty nutritional product; or</text></subparagraph> 
<subparagraph id="H97D92905E4A44412B12DE94BA500283A" commented="no"><enum>(B)</enum><text>to which one or more human milk or non-human milk components has been added to produce such a product.</text></subparagraph></paragraph> <paragraph id="H3BAAF2201F814A1FADDB00AFD17B3441" commented="no"><enum>(3)</enum><header>Donor human milk bank</header><text display-inline="yes-display-inline">The term <term>donor human milk bank</term> means an organization that—</text> 
<subparagraph commented="no" display-inline="no-display-inline" id="H0EF6CFAFE00E42E1BBF4B1CEFF5B8482"><enum>(A)</enum><text display-inline="yes-display-inline">meets standards established by the Food and Drug Administration for purposes of ensuring the safety of donor human milk and human milk banks, including such standards as may be prescribed pursuant to section 6; and</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HB32E7BA074E7488EBAF5C51FF3EDD578"><enum>(B)</enum><text display-inline="yes-display-inline">collects, tests, processes, pasteurizes, and distributes, in compliance with applicable Federal and State law, donor human milk or donor human milk derived products.</text></subparagraph> </paragraph> 
<paragraph commented="no" display-inline="no-display-inline" id="H18E3C9EABABE48688D331A7594AE4022"><enum>(4)</enum><header>Nonprofit donor human milk bank</header><text display-inline="yes-display-inline">The term <term>nonprofit donor human milk bank</term> means a donor human milk bank that is an organization—</text> <subparagraph id="H785647ED5124406A915B67CC1744412F"><enum>(A)</enum><text>described in <external-xref legal-doc="usc" parsable-cite="usc/26/501">section 501(c)(3)</external-xref> of the Internal Revenue Code of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/26/501">26 U.S.C. 501(c)(3)</external-xref>); and</text></subparagraph> 
<subparagraph id="H728BAF31B4D046069BE2450B79A22E41">
                    <enum>(B)</enum>
 <text>exempt from taxation under section 501(a) of such Code (<external-xref legal-doc="usc" parsable-cite="usc/26/501">26 U.S.C. 501(a)</external-xref>).</text>
                </subparagraph></paragraph></section> 
<section id="HBA0F8F9B54BC442DA545B8C1B5C56112"><enum>3.</enum><header>Support for donor human milk activities</header><text display-inline="no-display-inline">Section 17 of the Child Nutrition Act of 1966 (<external-xref legal-doc="usc" parsable-cite="usc/42/1786">42 U.S.C. 1786</external-xref>) is amended—</text> <paragraph id="H054D58C581CE4601858C436ED6FADEF1"> <enum>(1)</enum> <text>in subsection (b)(4), by inserting <quote>(including support for donor human milk (as defined in section 2 of the <short-title>Access to Donor Milk Act of 2026</short-title>) activities)</quote> after <quote>promotion</quote>; and</text>
            </paragraph> 
<paragraph id="H0701BD33A55E4061ADA7F7C89225186B"><enum>(2)</enum><text>in subsection (h)(1)(C)—</text> <subparagraph id="HCBEF8AF43770494BB4EDB54F7F8A21B5"><enum>(A)</enum><text>in clause (i), by striking <quote>clause (ii)</quote> and inserting <quote>clauses (ii) and (iii)</quote>; and</text></subparagraph> 
<subparagraph id="H3A2883D55AC24F48A9D564CCB8E37A50"><enum>(B)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H65A30477BD3643AEBC400295A5D9A6BC"> <clause id="H2C442023F7A845758CDB2EF551863FBA"><enum>(iii)</enum><header>Donor human milk</header><text>A State agency may use amounts made available under clause (i) for—</text> 
<subclause id="H339A8BA157CB433F87A0F2F36D7C0821"><enum>(I)</enum><text>collecting and storing donations of unprocessed human milk; and</text></subclause> <subclause id="HCBF6C741D98C417C9B0776B6B82B6D8B"> <enum>(II)</enum> <text display-inline="yes-display-inline">the transfer of the milk described in subclause (I) to a nonprofit donor human milk bank (as defined in section 2 of the <short-title>Access to Donor Milk Act of 2026</short-title>).</text>
                            </subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></section> 
<section id="H4709790286094FE694DB22426BDC3A95"><enum>4.</enum><header>Emergency capacity funding for human milk banks</header> 
<subsection id="HC77586731D08446A8253C54AD29AEABD"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall award competitive grants, subject to subsection (c), to eligible entities for expanding emergency capacity with respect to banking donor human milk.</text></subsection> <subsection id="H15E3ED10A65D46469C33253CB46DD54D"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">An eligible entity seeking a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.</text></subsection> 
<subsection id="HE9C94DD1D607454CAB8287E446CFFCC2"><enum>(c)</enum><header>Criteria</header><text>The Secretary may award grants under subsection (a) only in the event of any of the following:</text> <paragraph id="H263670C4E39F4A60B84A0373FF698F9F"><enum>(1)</enum><text>The Secretary determines that expanded capacity is necessary to respond to any major disaster declared by the President under section 401 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5170">42 U.S.C. 5170</external-xref>) or to any public health emergency declared under section 319 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d</external-xref>).</text></paragraph> 
<paragraph id="H2FB3666596854EF985253E1E0EF44ECE"><enum>(2)</enum><text display-inline="yes-display-inline">The President makes a determination described in section 102(1) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5122">42 U.S.C. 5122(1)</external-xref>), or the Secretary makes such a determination.</text></paragraph> <paragraph id="H5B689EFAECC745908E06B29B8B05AFCF"><enum>(3)</enum><text>The Secretary determines emergency capacity is needed to ensure adequate supply is available to meet the demand for donor human milk from an eligible entity.</text></paragraph></subsection> 
<subsection id="H7BB6B9EE68914D62BF0B31B22E8D40D4"><enum>(d)</enum><header>Use of funds</header><text display-inline="yes-display-inline">Expanding emergency capacity pursuant to a grant under this section may include—</text> <paragraph id="HE0CF0C245D03450A8F967BE2D58AA473"><enum>(1)</enum><text>publicizing the need for donor human milk, especially for high-risk infants;</text></paragraph> 
<paragraph id="H6D1DB6C151B94BADA47D3FBAC24ACA0B"><enum>(2)</enum><text>raising awareness and providing resources to families, especially families of high-risk infants, about donor human milk;</text></paragraph> <paragraph id="H5905EEC66EFC48929FAD99FB5CDBA2DF"><enum>(3)</enum><text>covering donor human milk collection, storage, pasteurization, transfer, and processing fees;</text></paragraph> 
<paragraph id="H48C1973BD8EA41D9976D182B7C0A729C"><enum>(4)</enum><text>increasing staffing and supplies needed at donor human milk banks;</text></paragraph> <paragraph id="HEA2417E6D9E24BFDA1E852A29D7DABA0"><enum>(5)</enum><text>purchasing consumable products needed for donor human milk processing; and</text></paragraph> 
<paragraph commented="no" display-inline="no-display-inline" id="HAE2CF82F4B6F460CB9EB91167BA66C38"><enum>(6)</enum><text>acquiring equipment for safety and quality processing of donor human milk.</text></paragraph></subsection> <subsection id="H71D55FF1DA8341108810F9BBEBCA91E8"><enum>(e)</enum><header>Eligible entity</header><text>For purposes of this section, the term <term>eligible entity</term> means an entity that—</text> 
<paragraph id="HA1A93E46F4E2462A9169F801B277F580"><enum>(1)</enum><text display-inline="yes-display-inline">is a nonprofit donor human milk bank; and</text></paragraph> <paragraph id="H4B8D2B08325C4162B264CC36A339CD40"><enum>(2)</enum><text display-inline="yes-display-inline">in the application submitted under subsection (b), demonstrates, with respect to such entity—</text> 
<subparagraph id="H9DF3B0DEC5314873925D16E467B3ED68"><enum>(A)</enum><text>a rapid increase in demand for donor human milk; or</text></subparagraph> <subparagraph id="H2D22C3BE3A39448B8F52C9226DCF84CF"><enum>(B)</enum><text>a shortage of supplies needed to operate a donor human milk bank.</text></subparagraph></paragraph></subsection> 
<subsection id="HA6191A4316E443E7942BBAB482EE6474"><enum>(f)</enum><header>Authorization of appropriations</header><text>For the purposes of carrying out this section, there are authorized to be appropriated $3,000,000 for fiscal year 2026, and such sums as may be necessary for each fiscal year thereafter.</text></subsection></section> <section id="HE3A80D3E02F44109964CA6EAD20359D0"><enum>5.</enum><header>Public awareness campaign with respect to donor human milk</header> <subsection id="H5A035A33C4324E6EAF0DB69A505B9965"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services—</text> 
<paragraph commented="no" display-inline="no-display-inline" id="H5577DA1C77BB4DDA9A82E77819F54A74"><enum>(1)</enum><text display-inline="yes-display-inline">shall, acting through the Administrator of the Health Resources and Services Administration, develop a public awareness campaign with respect to the benefits and safety of donor human milk from donor human milk banks; and</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H8A3E8B191244428096B9DACBA5A511E0"><enum>(2)</enum><text display-inline="yes-display-inline">may work with nonprofit donor human milk banks.</text></paragraph></subsection> 
<subsection id="H98D9FC48B7CD4E7AB13015BEDE46B3C1"><enum>(b)</enum><header>Distribution of educational materials</header><text>The public awareness campaign under subsection (a) shall include the distribution of educational materials to—</text> <paragraph id="HEC9F64DAABE346FFA2CE27950C589D93"><enum>(1)</enum><text>clinicians, such as pediatric specialists, pediatricians, obstetricians, pediatric nutritionists, midwives, and lactation consultants, including international board-certified lactation consultants;</text></paragraph> 
<paragraph id="H0DBD2173277A4A3E93F0D7F87B22A7CB"><enum>(2)</enum><text>expectant and new parents, with a focus on expectant and new parents that are participating in the special supplemental nutrition program for women, infants, and children program under section 17 of the Child Nutrition Act of 1966 (<external-xref legal-doc="usc" parsable-cite="usc/42/1786">42 U.S.C. 1786</external-xref>); and</text></paragraph> <paragraph id="H94EEE8C821E842D48CC1399727578C2F" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text>community-based organizations.</text></paragraph></subsection></section> 
<section id="H8F84D5A3E8BA4ECBB9E266979F46652E"><enum>6.</enum><header>Regulatory status of donor human milk</header> 
<subsection id="H31DE6E097C3A4141A7A64AAAD076B52C"><enum>(a)</enum><header>Public meeting</header><text display-inline="yes-display-inline">Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall, for purposes of assisting the Secretary in establishing minimum safety standards for donor human milk and donor human milk-derived products under subsection (c), convene a public meeting.</text></subsection> <subsection id="H55B89759F72448AB972AD758343C4C85"><enum>(b)</enum><header>Safety standards</header><text display-inline="yes-display-inline">In establishing the safety standards under subsection (c), the Secretary shall take into account—</text> 
<paragraph id="H6221A644CB9A4C4085B603253D3DF2E8"><enum>(1)</enum><text>the unique factors related to donor human milk and donor human milk-derived products;</text></paragraph> <paragraph id="HD478E719E7D94985A20C5FB12D429A29"><enum>(2)</enum><text>ethical considerations;</text></paragraph> 
<paragraph id="H380A22D1A1E441869F97F9C5F09CF6B7"><enum>(3)</enum><text>the protection of the United States donor milk supply; and</text></paragraph> <paragraph id="H933CBED489BF4E7CBA2EDF3B99004699"><enum>(4)</enum><text display-inline="yes-display-inline">the resources available to non-profit milk banks.</text></paragraph></subsection> 
<subsection id="HD6937172C8B74C5EB20C7EFF86DE277E"><enum>(c)</enum><header>Guidance</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Secretary shall issue draft guidance that—</text> <paragraph id="HE8A995AF284847F3BC482B2D95001DEB" commented="no"> <enum>(1)</enum> <text display-inline="yes-display-inline">establishes minimum appropriate safety standards for the collection and preparation, storage, handling, and processing through pasteurization, and transfer of donor human milk and donor human milk-derived products; and</text>
                </paragraph> 
<paragraph id="HFF6AAF2C1A57461184B84EF97CB87690">
                    <enum>(2)</enum>
 <text display-inline="yes-display-inline">considers the minimum appropriateness of screening, testing, and other processes, to ensure the safety of donor human milk and donor human milk-derived products, as determined by the Secretary.</text>
                </paragraph></subsection></section> 
</legis-body></bill>

