II 

117TH CONGRESS 

2D SESSION S. 5292 

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

IN THE SENATE OF THE UNITED STATES 

DECEMBER 15, 2022 

Ms. DUCKWORTH introduced the following bill; which was read twice and 

referred to the Committee on Agriculture, Nutrition, and Forestry 

A BILL 

To protect and expand access to donor 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 2022’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 

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

9 that is processed without additives. 

10 (2) The term ‘‘nonprofit milk bank’’ means a 

11 milk bank that— 


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1 (A) meets standards established by the 

2 Food and Drug Administration for purposes of 

3 ensuring the safety of donor milk and milk 

4 banks; 

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

6 and distributes donor milk, in compliance with 

7 applicable law; and 

8 (C) is described in section 501(c)(3) of the 

9 Internal Revenue Code of 1986 (26 U.S.C. 

10 501(c)(3)) and exempt from tax under section 

11 501(a) of such Code (26 U.S.C. 501(a)). 

12 SEC. 3. FINDINGS. 

13 Congress finds the following: 

14 (1) Human milk is the optimal first food for in15 fants. 

16 (2) Medically vulnerable infants, including those 

17 born prematurely and those with congenital or ac18 quired conditions, derive significant health benefits 

19 from human milk. 

20 (3) Mothers of medically vulnerable infants 

21 often face unique obstacles to producing enough 

22 milk. When a parent’s milk is not available, the pro23 vision of donor milk improves health outcomes for 

24 the infant, including decreasing rates of necrotizing 

25 enterocolitis. 


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1 (4) Nonprofit milk banks provide a critical 

2 medical service. 

3 (5) The nonprofit milk banking model of col4 lecting donor milk from uncompensated donors and 

5 accreditation ensures a safe and high-quality prod6 uct for the Nation’s most vulnerable infants. 

7 SEC. 4. SUPPORT FOR DONOR MILK ACTIVITIES. 

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

9 U.S.C. 1786) is amended— 

10 (1) in subsection (b)(4), by inserting ‘‘(includ11 ing support for donor milk (as defined in section 2 

12 of the Access to Donor Milk Act of 2022) activi13 ties)’’ after ‘‘promotion’’; and 

14 (2) in subsection (h)(1)(C)— 

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

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

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

18 ‘‘(iii) DONOR MILK.—A State agency 

19 may use amounts made available under 

20 clause (i) for— 

21 ‘‘(I) collecting and storing dona22 tions of unprocessed human milk; 

23 ‘‘(II) the transfer of the milk de24 scribed in subclause (I) to a nonprofit 

25 milk bank; and 


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1 ‘‘(III) making the milk trans2 ferred to a nonprofit milk bank under 

3 subclause (II) available to program 

4 participants at low or zero cost.’’. 

5 SEC. 5. EMERGENCY CAPACITY FUNDING FOR MILK BANKS. 

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

7 Human Services (referred to in this section as the ‘‘Sec8 retary’’) shall award competitive grants, subject to sub9 section (f), to eligible entities for expanding emergency ca10 pacity with respect to banking donor milk. 

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

12 under this section shall submit an application to the Sec13 retary at such time, in such manner, and containing such 

14 information as the Secretary may require. 

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

16 pursuant to a grant under this section may include— 

17 (1) publicizing the need for donor milk; 

18 (2) providing resources to patients and pro19 viding information to clinicians about donor milk; 

20 (3) covering donor milk collection, storage, 

21 transfer, and processing fees; 

22 (4) increasing staffing and supplies needed at 

23 nonprofit milk banks; and 

24 (5) purchasing consumable products needed for 

25 donor milk processing. 


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

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

3 (1) is a nonprofit milk bank accredited by an 

4 accrediting body recognized by the Food and Drug 

5 Administration; and 

6 (2) in the application submitted under sub7 section (b), demonstrates, with respect to such enti8 ty— 

9 (A) a rapid increase in demand for donor 

10 milk; or 

11 (B) a shortage of supplies needed to oper12 ate a nonprofit milk bank. 

13 (e) AUTHORIZATION OF APPROPRIATIONS.—For the 

14 purposes of carrying out this section, there are authorized 

15 to be appropriated $3,000,000 for fiscal year 2023, and 

16 such sums as may be necessary for each fiscal year there17 after. 

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

19 under subsection (a) only in the event of any of the fol20 lowing: 

21 (1) The Secretary determines that expanded ca22 pacity is necessary to respond to any major disaster 

23 declared by the President under section 401 of the 

24 Robert T. Stafford Disaster Relief and Emergency 

25 Assistance Act (42 U.S.C. 5170). 


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1 (2) The Secretary determines that Federal as2 sistance is needed to supplement State and local ef3 forts and capabilities to save lives and to protect 

4 property and public health and safety, or to lessen 

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

6 the United States. 

7 (3) The Secretary determines emergency capac8 ity is needed to ensure adequate supply is available 

9 to meet the demand for donor milk from a nonprofit 

10 donor milk bank. 

11 SEC. 6. DONOR MILK AWARENESS PROGRAM. 

12 (a) CHILD NUTRITION.—The Child Nutrition Act of 

13 1966 (42 U.S.C. 1771 et seq.) is amended by adding at 

14 the end the following: 

15 ‘‘SEC. 24. DONOR MILK AWARENESS PROGRAM. 

16 ‘‘(a) DEFINITION OF DONOR MILK.—In this section, 

17 the term ‘donor milk’ has the meaning given the term in 

18 section 2 of the Access to Donor Milk Act of 2022. 

19 ‘‘(b) ESTABLISHMENT.—The Secretary shall estab20 lish a donor milk awareness program (referred to in this 

21 section as the ‘program’)— 

22 ‘‘(1) to educate the public on donor milk and 

23 nonprofit milk banks; and 

24 ‘‘(2) to publicize the need for donor milk to be 

25 provided to nonprofit milk banks. 


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1 ‘‘(c) CONDUCT OF PROGRAM.—In carrying out the 

2 program, the Secretary may— 

3 ‘‘(1) develop, or assist other entities to develop, 

4 appropriate educational materials, including public 

5 service announcements, promotional publications, 

6 and press kits, for the program; 

7 ‘‘(2) publish information about the program on 

8 the website of the Department of Agriculture; and 

9 ‘‘(3) distribute, or assist other entities to dis10 tribute, such materials, as appropriate, to public and 

11 private individuals and entities. 

12 ‘‘(d) COOPERATIVE AGREEMENTS.—The Secretary 

13 may enter into cooperative agreements with Federal agen14 cies, State and local governments, and other entities to 

15 carry out the program. 

16 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For 

17 purposes of carrying out the program, there is authorized 

18 to be appropriated $1,000,000 for fiscal year 2023.’’. 

19 (b) HHS PUBLIC AWARENESS CAMPAIGN WITH RE20 SPECT TO DONOR MILK FROM NONPROFIT MILK

21 BANKS.— 

22 (1) IN GENERAL.—The Secretary of Health and 

23 Human Services shall develop a public awareness 

24 campaign with respect to donor milk from nonprofit 

25 milk banks. 


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1 (2) DISTRIBUTION OF EDUCATIONAL MATE2 RIALS.—The public awareness campaign under para3 graph (1) shall include the distribution of edu4 cational materials to— 

5 (A) clinicians, such as pediatric specialists, 

6 pediatricians, obstetricians, pediatric nutrition7 ists, midwives, and lactation consultants; 

8 (B) expectant and new parents; and 

9 (C) community-based organizations. 

10 SEC. 7. CLARIFYING THE REGULATORY STATUS OF DONOR 

11 MILK. 

12 (a) IN GENERAL.—Not later than 1 year after the 

13 date of the enactment of this Act, the Secretary of Health 

14 and Human Services shall issue guidance to clarify the 

15 regulatory status (and any associated categorization) of 

16 donor milk provided by a nonprofit milk bank. 

17 (b) REPORT.—Not later than 180 days after the date 

18 of the enactment of this Act, the Secretary of Health and 

19 Human Services shall submit to Congress a report regard20 ing the issuance of guidance on the categorization of donor 

21 milk provided by a nonprofit milk bank under the rule 

22 issued under subsection (a). 

Æ 


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