H.R. 8545

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8545 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8545

To protect and expand access to pasteurized, donor human milk, and for 
other purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

April 28, 2026

Ms. Houlahan (for herself, Mrs. Bice, and Ms. Salazar) introduced the 
following bill; which was referred to the Committee on Energy and 
Commerce, and in addition to the Committee on Education and Workforce, 
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

_______________________________________________________________________

A BILL

To protect and expand access to pasteurized, donor human milk, 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 ``Access to Donor Milk Act of 2026''.

SEC. 2. DEFINITIONS.

In this Act:
(1) Donor human milk.--The term ``donor human milk'' means 
human milk that is collected, pasteurized, and dispensed 
without additives.
(2) Donor human milk-derived product.--The term ``donor 
human milk-derived product'' means a product made predominantly 
from donor human milk--
(A) from which one or more components has been 
removed in order to produce a specialty nutritional 
product; or
(B) to which one or more human milk or non-human 
milk components has been added to produce such a 
product.
(3) Donor human milk bank.--The term ``donor human milk 
bank'' means an organization that--
(A) 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
(B) collects, tests, processes, pasteurizes, and 
distributes, in compliance with applicable Federal and 
State law, donor human milk or donor human milk derived 
products.
(4) Nonprofit donor human milk bank.--The term ``nonprofit 
donor human milk bank'' means a donor human milk bank that is 
an organization--
(A) described in section 501(c)(3) of the Internal 
Revenue Code of 1986 (26 U.S.C. 501(c)(3)); and
(B) exempt from taxation under section 501(a) of 
such Code (26 U.S.C. 501(a)).

SEC. 3. SUPPORT FOR DONOR HUMAN MILK ACTIVITIES.

Section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786) is 
amended--
(1) in subsection (b)(4), by inserting ``(including support 
for donor human milk (as defined in section 2 of the Access to 
Donor Milk Act of 2026) activities)'' after ``promotion''; and
(2) in subsection (h)(1)(C)--
(A) in clause (i), by striking ``clause (ii)'' and 
inserting ``clauses (ii) and (iii)''; and
(B) by adding at the end the following:
``(iii) Donor human milk.--A State agency 
may use amounts made available under clause (i) 
for--
``(I) collecting and storing 
donations of unprocessed human milk; 
and
``(II) the transfer of the milk 
described in subclause (I) to a 
nonprofit donor human milk bank (as 
defined in section 2 of the Access to 
Donor Milk Act of 2026).''.

SEC. 4. EMERGENCY CAPACITY FUNDING FOR HUMAN MILK BANKS.

(a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall award 
competitive grants, subject to subsection (c), to eligible entities for 
expanding emergency capacity with respect to banking donor human milk.
(b) Application.--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.
(c) Criteria.--The Secretary may award grants under subsection (a) 
only in the event of any of the following:
(1) 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 (42 U.S.C. 5170) or to any 
public health emergency declared under section 319 of the 
Public Health Service Act (42 U.S.C. 247d).
(2) The President makes a determination described in 
section 102(1) of the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (42 U.S.C. 5122(1)), or the Secretary 
makes such a determination.
(3) 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.
(d) Use of Funds.--Expanding emergency capacity pursuant to a grant 
under this section may include--
(1) publicizing the need for donor human milk, especially 
for high-risk infants;
(2) raising awareness and providing resources to families, 
especially families of high-risk infants, about donor human 
milk;
(3) covering donor human milk collection, storage, 
pasteurization, transfer, and processing fees;
(4) increasing staffing and supplies needed at donor human 
milk banks;
(5) purchasing consumable products needed for donor human 
milk processing; and
(6) acquiring equipment for safety and quality processing 
of donor human milk.
(e) Eligible Entity.--For purposes of this section, the term 
``eligible entity'' means an entity that--
(1) is a nonprofit donor human milk bank; and
(2) in the application submitted under subsection (b), 
demonstrates, with respect to such entity--
(A) a rapid increase in demand for donor human 
milk; or
(B) a shortage of supplies needed to operate a 
donor human milk bank.
(f) Authorization of Appropriations.--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.

SEC. 5. PUBLIC AWARENESS CAMPAIGN WITH RESPECT TO DONOR HUMAN MILK.

(a) In General.--The Secretary of Health and Human Services--
(1) 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
(2) may work with nonprofit donor human milk banks.
(b) Distribution of Educational Materials.--The public awareness 
campaign under subsection (a) shall include the distribution of 
educational materials to--
(1) clinicians, such as pediatric specialists, 
pediatricians, obstetricians, pediatric nutritionists, 
midwives, and lactation consultants, including international 
board-certified lactation consultants;
(2) 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 (42 
U.S.C. 1786); and
(3) community-based organizations.

SEC. 6. REGULATORY STATUS OF DONOR HUMAN MILK.

(a) Public Meeting.--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 ``Secretary'') 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.
(b) Safety Standards.--In establishing the safety standards under 
subsection (c), the Secretary shall take into account--
(1) the unique factors related to donor human milk and 
donor human milk-derived products;
(2) ethical considerations;
(3) the protection of the United States donor milk supply; 
and
(4) the resources available to non-profit milk banks.
(c) Guidance.--Not later than 18 months after the date of enactment 
of this Act, the Secretary shall issue draft guidance that--
(1) 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
(2) 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.
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