II 

118TH CONGRESS 

1ST SESSION S. 2819 

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

other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 14, 2023 

Mr. DURBIN for (Ms. DUCKWORTH (for herself and Mr. RUBIO)) introduced 

the following bill; which was read twice and referred to the Committee 

on Health, Education, Labor, and Pensions 

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: 

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

9 human milk that is collected, pasteurized, and dis10 pensed without additives. 


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

2 an organization that— 

3 (A) meets standards established by the 

4 Food and Drug Administration for purposes of 

5 ensuring the safety of donor human milk and 

6 human milk banks; and 

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

8 and distributes donor human milk, in compli9 ance with applicable law. 

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

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

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

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

14 1986 (26 U.S.C. 501(c)(3)) and exempt from tax 

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

16 501(a)). 

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

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

19 U.S.C. 1786) is amended— 

20 (1) in subsection (b)(4), by inserting ‘‘(includ21 ing support for donor human milk (as defined in 

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

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

24 (2) in subsection (h)(1)(C)— 


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

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

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

4 ‘‘(iii) DONOR HUMAN MILK.—A State 

5 agency may use amounts made available 

6 under clause (i) for— 

7 ‘‘(I) collecting and storing dona8 tions of unprocessed human milk; and 

9 ‘‘(II) the transfer of the milk de10 scribed in subclause (I) to a nonprofit 

11 donor human milk bank (as defined in 

12 section 2 of the Access to Donor Milk 

13 Act of 2023) registered with the Food 

14 and Drug Administration.’’. 

15 SEC. 4. EMERGENCY CAPACITY FUNDING FOR HUMAN MILK 

16 BANKS. 

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

18 Human Services (referred to in this section as the ‘‘Sec19 retary’’) shall award competitive grants, subject to sub20 section (f), to eligible entities for expanding emergency ca21 pacity with respect to banking donor human milk. 

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

23 under this section shall submit an application to the Sec24 retary at such time, in such manner, and containing such 

25 information as the Secretary may require. 


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

2 pursuant to a grant under this section may include— 

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

4 especially for high-risk infants; 

5 (2) raising awareness and providing resources 

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

7 about donor human milk; 

8 (3) covering donor human milk collection, stor9 age, pasteurization, transfer, and processing fees; 

10 (4) increasing staffing and supplies needed at 

11 donor human milk banks; 

12 (5) purchasing consumable products needed for 

13 donor human milk processing; and 

14 (6) acquiring equipment for safe and quality 

15 processing of donor human milk. 

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

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

18 (1) is a nonprofit donor human milk bank reg19 istered with the Food and Drug Administration; and 

20 (2) in the application submitted under sub21 section (b), demonstrates, with respect to such enti22 ty— 

23 (A) a rapid increase in demand for donor 

24 human milk; or 


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1 (B) a shortage of supplies needed to oper2 ate a donor human milk bank. 

3 (e) AUTHORIZATION OF APPROPRIATIONS.—For the 

4 purposes of carrying out this section, there are authorized 

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

6 such sums as may be necessary for each fiscal year there7 after. 

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

9 under subsection (a) only in the event of any of the fol10 lowing: 

11 (1) The Secretary determines that expanded ca12 pacity is necessary to respond to any major disaster 

13 declared by the President under section 401 of the 

14 Robert T. Stafford Disaster Relief and Emergency 

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

16 health emergency declared under section 319 of the 

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

18 (2) The Secretary determines that Federal as19 sistance is needed to supplement State and local ef20 forts and capabilities to save lives and to protect 

21 property and public health and safety, or to lessen 

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

23 the United States. 

24 (3) The Secretary determines emergency capac25 ity is needed to ensure adequate supply is available 


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1 to meet the demand for donor human milk from an 

2 eligible entity. 

3 SEC. 5. PUBLIC AWARENESS CAMPAIGN WITH RESPECT TO 

4 DONOR HUMAN MILK. 

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

6 Human Services— 

7 (1) shall, acting through the Administrator of 

8 the Health Resources and Services Administration, 

9 develop a public awareness campaign with respect to 

10 the benefits and safety of donor human milk from 

11 donor human milk banks registered with the Food 

12 and Drug Administration; and 

13 (2) is encouraged to work with nonprofit donor 

14 human milk banks registered with the Food and 

15 Drug Administration. 

16 (b) DISTRIBUTION OF EDUCATIONAL MATERIALS.— 

17 The public awareness campaign under subsection (a) shall 

18 include the distribution of educational materials to— 

19 (1) clinicians, such as pediatric specialists, pedi20 atricians, obstetricians, pediatric nutritionists, mid21 wives, and lactation consultants, including inter22 national board-certified lactation consultants; 

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

24 expectant and new parents that are participating in 

25 the special supplemental nutrition program for 


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1 women, infants, and children program under section 

2 17 of the Child Nutrition Act of 1966 (42 U.S.C. 

3 1786); and 

4 (3) community-based organizations. 

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

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

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

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

9 as the ‘‘Secretary’’) shall convene a public meeting to in10 form the draft guidance required under subsection (b). 

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

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

13 draft guidance that— 

14 (1) addresses the appropriate standards for the 

15 collection and preparation, storage, handling, proc16 esses used in pasteurization, and transfer of donor 

17 human milk and donor human-milk derived prod18 ucts; and 

19 (2) considers the appropriateness of screening 

20 and other processes, as determined by the Secretary. 

Æ 


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