[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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