I 
118TH CONGRESS 
1ST SESSION H. R. 5486 
To protect and expand access to pasteurized, donor human milk, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 14, 2023 
Ms. HOULAHAN (for herself, Mrs. BICE, Ms. SALAZAR, Ms. MACE, and Mrs. 
LESKO) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Education and the 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 Representa-
tives 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 2023’’. 
SEC. 2. DEFINITIONS. 
In this Act: 
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(1) The term ‘‘donor human milk’’ means 
human milk that is collected, pasteurized, and dis-
pensed without additives. 
(2) 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; and 
(B) collects, tests, processes, pasteurizes, 
and distributes donor human milk, in compli-
ance with applicable law. 
(3) The term ‘‘nonprofit donor human milk 
bank’’ means a donor human milk bank (as defined 
in paragraph (2)) that is an organization described 
in section 501(c)(3) of the Internal Revenue Code of 
1986 (26 U.S.C. 501(c)(3)) and exempt from tax 
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 ‘‘(includ-
ing support for donor human milk (as defined in 
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section 2 of the Access to Donor Milk Act of 2023) 
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 dona-
tions of unprocessed human milk; and 
‘‘(II) the transfer of the milk de-
scribed in subclause (I) to a nonprofit 
donor human milk bank (as defined in 
section 2 of the Access to Donor Milk 
Act of 2023) registered with the Food 
and Drug Administration.’’. 
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 ‘‘Sec-
retary’’) shall award competitive grants, subject to sub-
section (f), to eligible entities for expanding emergency ca-
pacity with respect to banking donor human milk. 
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(b) APPLICATION.—An eligible entity seeking a grant 
under this section shall submit an application to the Sec-
retary at such time, in such manner, and containing such 
information as the Secretary may require. 
(c) 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, stor-
age, 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 safe and quality 
processing of donor human milk. 
(d) ELIGIBLE ENTITY.—For purposes of this section, 
the term ‘‘eligible entity’’ means an entity that— 
(1) is a nonprofit donor human milk bank reg-
istered with the Food and Drug Administration; and 
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(2) in the application submitted under sub-
section (b), demonstrates, with respect to such enti-
ty— 
(A) a rapid increase in demand for donor 
human milk; or 
(B) a shortage of supplies needed to oper-
ate a donor human milk bank. 
(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purposes of carrying out this section, there are authorized 
to be appropriated $3,000,000 for fiscal year 2024, and 
such sums as may be necessary for each fiscal year there-
after. 
(f) CRITERIA.—The Secretary may award grants 
under subsection (a) only in the event of any of the fol-
lowing: 
(1) The Secretary determines that expanded ca-
pacity 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 Secretary determines that Federal as-
sistance is needed to supplement State and local ef-
forts and capabilities to save lives and to protect 
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property and public health and safety, or to lessen 
or avert the threat of a catastrophe in any part of 
the United States. 
(3) The Secretary determines emergency capac-
ity is needed to ensure adequate supply is available 
to meet the demand for donor human milk from an 
eligible entity. 
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 registered with the Food 
and Drug Administration; and 
(2) is encouraged to work with nonprofit donor 
human milk banks registered with the Food and 
Drug Administration. 
(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, pedi-
atricians, obstetricians, pediatric nutritionists, mid-
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wives, and lactation consultants, including inter-
national 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 convene a public meeting to in-
form the draft guidance required under subsection (b). 
(b) GUIDANCE.—Not later than 18 months after the 
date of enactment of this Act, the Secretary shall issue 
draft guidance that— 
(1) addresses the appropriate standards for the 
collection and preparation, storage, handling, proc-
esses used in pasteurization, and transfer of donor 
human milk and donor human-milk derived prod-
ucts; and 
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(2) considers the appropriateness of screening 
and other processes, as determined by the Secretary. 
Æ 
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