[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5292 Introduced in Senate (IS)]

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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.

    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 2022''.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) The term ``donor milk'' means human milk that is 
        processed without additives.
            (2) The term ``nonprofit milk bank'' means a milk bank 
        that--
                    (A) meets standards established by the Food and 
                Drug Administration for purposes of ensuring the safety 
                of donor milk and milk banks;
                    (B) collects, tests, processes, pasteurizes, and 
                distributes donor milk, in compliance with applicable 
                law; and
                    (C) is 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. FINDINGS.

    Congress finds the following:
            (1) Human milk is the optimal first food for infants.
            (2) Medically vulnerable infants, including those born 
        prematurely and those with congenital or acquired conditions, 
        derive significant health benefits from human milk.
            (3) Mothers of medically vulnerable infants often face 
        unique obstacles to producing enough milk. When a parent's milk 
        is not available, the provision of donor milk improves health 
        outcomes for the infant, including decreasing rates of 
        necrotizing enterocolitis.
            (4) Nonprofit milk banks provide a critical medical 
        service.
            (5) The nonprofit milk banking model of collecting donor 
        milk from uncompensated donors and accreditation ensures a safe 
        and high-quality product for the Nation's most vulnerable 
        infants.

SEC. 4. SUPPORT FOR DONOR 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 milk (as defined in section 2 of the Access to Donor 
        Milk Act of 2022) 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 milk.--A State agency may use 
                        amounts made available under clause (i) for--
                                    ``(I) collecting and storing 
                                donations of unprocessed human milk;
                                    ``(II) the transfer of the milk 
                                described in subclause (I) to a 
                                nonprofit milk bank; and
                                    ``(III) making the milk transferred 
                                to a nonprofit milk bank under 
                                subclause (II) available to program 
                                participants at low or zero cost.''.

SEC. 5. EMERGENCY CAPACITY FUNDING FOR 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 (f), to eligible entities for 
expanding emergency capacity with respect to banking donor 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) Use of Funds.-- Expanding emergency capacity pursuant to a 
grant under this section may include--
            (1) publicizing the need for donor milk;
            (2) providing resources to patients and providing 
        information to clinicians about donor milk;
            (3) covering donor milk collection, storage, transfer, and 
        processing fees;
            (4) increasing staffing and supplies needed at nonprofit 
        milk banks; and
            (5) purchasing consumable products needed for donor milk 
        processing.
    (d) Eligible Entity.--For purposes of this section, the term 
``eligible entity'' means an entity that--
            (1) is a nonprofit milk bank accredited by an accrediting 
        body recognized by the Food and Drug Administration; and
            (2) in the application submitted under subsection (b), 
        demonstrates, with respect to such entity--
                    (A) a rapid increase in demand for donor milk; or
                    (B) a shortage of supplies needed to operate a 
                nonprofit 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 2023, and such sums as may be necessary for each fiscal 
year thereafter.
    (f) 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).
            (2) The Secretary determines that Federal assistance is 
        needed to supplement State and local efforts and capabilities 
        to save lives and to protect 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 capacity is needed 
        to ensure adequate supply is available to meet the demand for 
        donor milk from a nonprofit donor milk bank.

SEC. 6. DONOR MILK AWARENESS PROGRAM.

    (a) Child Nutrition.--The Child Nutrition Act of 1966 (42 U.S.C. 
1771 et seq.) is amended by adding at the end the following:

``SEC. 24. DONOR MILK AWARENESS PROGRAM.

    ``(a) Definition of Donor Milk.--In this section, the term `donor 
milk' has the meaning given the term in section 2 of the Access to 
Donor Milk Act of 2022.
    ``(b) Establishment.--The Secretary shall establish a donor milk 
awareness program (referred to in this section as the `program')--
            ``(1) to educate the public on donor milk and nonprofit 
        milk banks; and
            ``(2) to publicize the need for donor milk to be provided 
        to nonprofit milk banks.
    ``(c) Conduct of Program.--In carrying out the program, the 
Secretary may--
            ``(1) develop, or assist other entities to develop, 
        appropriate educational materials, including public service 
        announcements, promotional publications, and press kits, for 
        the program;
            ``(2) publish information about the program on the website 
        of the Department of Agriculture; and
            ``(3) distribute, or assist other entities to distribute, 
        such materials, as appropriate, to public and private 
        individuals and entities.
    ``(d) Cooperative Agreements.--The Secretary may enter into 
cooperative agreements with Federal agencies, State and local 
governments, and other entities to carry out the program.
    ``(e) Authorization of Appropriations.--For purposes of carrying 
out the program, there is authorized to be appropriated $1,000,000 for 
fiscal year 2023.''.
    (b) HHS Public Awareness Campaign With Respect to Donor Milk From 
Nonprofit Milk Banks.--
            (1) In general.--The Secretary of Health and Human Services 
        shall develop a public awareness campaign with respect to donor 
        milk from nonprofit milk banks.
            (2) Distribution of educational materials.--The public 
        awareness campaign under paragraph (1) shall include the 
        distribution of educational materials to--
                    (A) clinicians, such as pediatric specialists, 
                pediatricians, obstetricians, pediatric nutritionists, 
                midwives, and lactation consultants;
                    (B) expectant and new parents; and
                    (C) community-based organizations.

SEC. 7. CLARIFYING THE REGULATORY STATUS OF DONOR MILK.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
issue guidance to clarify the regulatory status (and any associated 
categorization) of donor milk provided by a nonprofit milk bank.
    (b) Report.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to Congress a report regarding the issuance of guidance on the 
categorization of donor milk provided by a nonprofit milk bank under 
the rule issued under subsection (a).
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