[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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