Section 1 Short title
This Act may be cited as the “Access to Donor Milk Act of 2022”.
Access to Donor Milk Act of 2022
A BILL
To protect and expand access to donor milk, and for other purposes.
Sec. 2 Definitions
In this Act:
The term donor milk means human milk that is processed without additives.
The term nonprofit milk bank means a milk bank that—
meets standards established by the Food and Drug Administration for purposes of ensuring the safety of donor milk and milk banks;
collects, tests, processes, pasteurizes, and distributes donor milk, in compliance with applicable law; and
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:
Human milk is the optimal first food for infants.
Medically vulnerable infants, including those born prematurely and those with congenital or acquired conditions, derive significant health benefits from human milk.
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.
Nonprofit milk banks provide a critical medical service.
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—
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
in subsection (h)(1)(C)—
in clause (i), by striking “clause (ii)” and inserting “clauses (ii) and (iii)”; and
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
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.
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.
Use of funds— Expanding emergency capacity pursuant to a grant under this section may include—
publicizing the need for donor milk;
providing resources to patients and providing information to clinicians about donor milk;
covering donor milk collection, storage, transfer, and processing fees;
increasing staffing and supplies needed at nonprofit milk banks; and
purchasing consumable products needed for donor milk processing.
Eligible entity— For purposes of this section, the term eligible entity means an entity that—
is a nonprofit milk bank accredited by an accrediting body recognized by the Food and Drug Administration; and
in the application submitted under subsection (b), demonstrates, with respect to such entity—
a rapid increase in demand for donor milk; or
a shortage of supplies needed to operate a nonprofit milk bank.
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.
Criteria— The Secretary may award grants under subsection (a) only in the event of any of the following:
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).
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.
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
Child nutrition— The Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.) is amended by adding at the end the following:
“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.”
HHS public awareness campaign with respect to donor milk from nonprofit milk banks—
In general— The Secretary of Health and Human Services shall develop a public awareness campaign with respect to donor milk from nonprofit milk banks.
Distribution of educational materials— The public awareness campaign under paragraph (1) shall include the distribution of educational materials to—
clinicians, such as pediatric specialists, pediatricians, obstetricians, pediatric nutritionists, midwives, and lactation consultants;
expectant and new parents; and
community-based organizations.
Sec. 7 Clarifying the regulatory status of donor milk
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.
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).