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 Committee 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Donor Milk 

5 Act of 2023’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 


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1 (1) The term ‘‘donor human milk’’ means 

2 human milk that is collected, pasteurized, and dis3 pensed without additives. 

4 (2) The term ‘‘donor human milk bank’’ means 

5 an organization that— 

6 (A) meets standards established by the 

7 Food and Drug Administration for purposes of 

8 ensuring the safety of donor human milk and 

9 human milk banks; and 

10 (B) collects, tests, processes, pasteurizes, 

11 and distributes donor human milk, in compli12 ance with applicable law. 

13 (3) The term ‘‘nonprofit donor human milk 

14 bank’’ means a donor human milk bank (as defined 

15 in paragraph (2)) that is an organization described 

16 in section 501(c)(3) of the Internal Revenue Code of 

17 1986 (26 U.S.C. 501(c)(3)) and exempt from tax 

18 under section 501(a) of such Code (26 U.S.C. 

19 501(a)). 

20 SEC. 3. SUPPORT FOR DONOR HUMAN MILK ACTIVITIES. 

21 Section 17 of the Child Nutrition Act of 1966 (42 

22 U.S.C. 1786) is amended— 

23 (1) in subsection (b)(4), by inserting ‘‘(includ24 ing support for donor human milk (as defined in 


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1 section 2 of the Access to Donor Milk Act of 2023) 

2 activities)’’ after ‘‘promotion’’; and 

3 (2) in subsection (h)(1)(C)— 

4 (A) in clause (i), by striking ‘‘clause (ii)’’ 

5 and inserting ‘‘clauses (ii) and (iii)’’; and 

6 (B) by adding at the end the following: 

7 ‘‘(iii) DONOR HUMAN MILK.—A State 

8 agency may use amounts made available 

9 under clause (i) for— 

10 ‘‘(I) collecting and storing dona11 tions of unprocessed human milk; and 

12 ‘‘(II) the transfer of the milk de13 scribed in subclause (I) to a nonprofit 

14 donor human milk bank (as defined in 

15 section 2 of the Access to Donor Milk 

16 Act of 2023) registered with the Food 

17 and Drug Administration.’’. 

18 SEC. 4. EMERGENCY CAPACITY FUNDING FOR HUMAN MILK 

19 BANKS. 

20 (a) IN GENERAL.—The Secretary of Health and 

21 Human Services (referred to in this section as the ‘‘Sec22 retary’’) shall award competitive grants, subject to sub23 section (f), to eligible entities for expanding emergency ca24 pacity with respect to banking donor human milk. 


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1 (b) APPLICATION.—An eligible entity seeking a grant 

2 under this section shall submit an application to the Sec3 retary at such time, in such manner, and containing such 

4 information as the Secretary may require. 

5 (c) USE OF FUNDS.— Expanding emergency capacity 

6 pursuant to a grant under this section may include— 

7 (1) publicizing the need for donor human milk, 

8 especially for high-risk infants; 

9 (2) raising awareness and providing resources 

10 to families, especially families of high-risk infants, 

11 about donor human milk; 

12 (3) covering donor human milk collection, stor13 age, pasteurization, transfer, and processing fees; 

14 (4) increasing staffing and supplies needed at 

15 donor human milk banks; 

16 (5) purchasing consumable products needed for 

17 donor human milk processing; and 

18 (6) acquiring equipment for safe and quality 

19 processing of donor human milk. 

20 (d) ELIGIBLE ENTITY.—For purposes of this section, 

21 the term ‘‘eligible entity’’ means an entity that— 

22 (1) is a nonprofit donor human milk bank reg23 istered with the Food and Drug Administration; and 


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1 (2) in the application submitted under sub2 section (b), demonstrates, with respect to such enti3 ty— 

4 (A) a rapid increase in demand for donor 

5 human milk; or 

6 (B) a shortage of supplies needed to oper7 ate a donor human milk bank. 

8 (e) AUTHORIZATION OF APPROPRIATIONS.—For the 

9 purposes of carrying out this section, there are authorized 

10 to be appropriated $3,000,000 for fiscal year 2024, and 

11 such sums as may be necessary for each fiscal year there12 after. 

13 (f) CRITERIA.—The Secretary may award grants 

14 under subsection (a) only in the event of any of the fol15 lowing: 

16 (1) The Secretary determines that expanded ca17 pacity is necessary to respond to any major disaster 

18 declared by the President under section 401 of the 

19 Robert T. Stafford Disaster Relief and Emergency 

20 Assistance Act (42 U.S.C. 5170) or to any public 

21 health emergency declared under section 319 of the 

22 Public Health Service Act (42 U.S.C. 247d). 

23 (2) The Secretary determines that Federal as24 sistance is needed to supplement State and local ef25 forts and capabilities to save lives and to protect 


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1 property and public health and safety, or to lessen 

2 or avert the threat of a catastrophe in any part of 

3 the United States. 

4 (3) The Secretary determines emergency capac5 ity is needed to ensure adequate supply is available 

6 to meet the demand for donor human milk from an 

7 eligible entity. 

8 SEC. 5. PUBLIC AWARENESS CAMPAIGN WITH RESPECT TO 

9 DONOR HUMAN MILK. 

10 (a) IN GENERAL.—The Secretary of Health and 

11 Human Services— 

12 (1) shall, acting through the Administrator of 

13 the Health Resources and Services Administration, 

14 develop a public awareness campaign with respect to 

15 the benefits and safety of donor human milk from 

16 donor human milk banks registered with the Food 

17 and Drug Administration; and 

18 (2) is encouraged to work with nonprofit donor 

19 human milk banks registered with the Food and 

20 Drug Administration. 

21 (b) DISTRIBUTION OF EDUCATIONAL MATERIALS.— 

22 The public awareness campaign under subsection (a) shall 

23 include the distribution of educational materials to— 

24 (1) clinicians, such as pediatric specialists, pedi25 atricians, obstetricians, pediatric nutritionists, midVerDate Sep 11 2014 01:04 Sep 16, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5486.IH H5486

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1 wives, and lactation consultants, including inter2 national board-certified lactation consultants; 

3 (2) expectant and new parents, with a focus on 

4 expectant and new parents that are participating in 

5 the special supplemental nutrition program for 

6 women, infants, and children program under section 

7 17 of the Child Nutrition Act of 1966 (42 U.S.C. 

8 1786); and 

9 (3) community-based organizations. 

10 SEC. 6. REGULATORY STATUS OF DONOR HUMAN MILK. 

11 (a) PUBLIC MEETING.—Not later than 180 days 

12 after the date of the enactment of this Act, the Secretary 

13 of Health and Human Services (referred to in this section 

14 as the ‘‘Secretary’’) shall convene a public meeting to in15 form the draft guidance required under subsection (b). 

16 (b) GUIDANCE.—Not later than 18 months after the 

17 date of enactment of this Act, the Secretary shall issue 

18 draft guidance that— 

19 (1) addresses the appropriate standards for the 

20 collection and preparation, storage, handling, proc21 esses used in pasteurization, and transfer of donor 

22 human milk and donor human-milk derived prod23 ucts; and 


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1 (2) considers the appropriateness of screening 

2 and other processes, as determined by the Secretary. 

Æ 


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