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 by a nonprofit milk bank.
The term nonprofit milk bank means a milk bank that—
is accredited by an accrediting body that is recognized by, or meets standards established by, the Food and Drug Administration for purposes of accrediting milk banks;
collects, tests, processes, pasteurizes, and distributes donor milk; 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.
Nonprofit milk banks provide an essential medical service.
The nonprofit milk banking model of donor non-remuneration and standardized processing of single ingredient pools 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 activities)” after “promotion”; and
in subsection (h)(1)(C), by adding at the end the following:
“(iii) Donor milk—A State agency may use amounts made available under clause (i) for the collection and storage of unprocessed donations of human milk, the transfer of such milk to a nonprofit milk bank, and to make donor milk available to program participants.”
Sec. 5 Emergency capacity funding for milk banks
In general— The Secretary shall award competitive grants 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, making patients aware of donor milk, and providing information to clinicians about donor milk;
covering donor milk processing fees;
increasing staffing and supplies needed at nonprofit milk banks; and
purchasing consumable products needed for donor milk processing.
Definitions— In this section:
Eligible entity— The term eligible entity means an entity that—
is recognized by the Food and Drug Administration as an accrediting body for nonprofit milk banks; 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.
Secretary— The term Secretary means the Secretary of Health and Humans Services, acting through the Commissioner of Food and Drugs.
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.
Sec. 6 Donor milk awareness program
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) In general—The Secretary, in coordination with the Secretary of Health and Human Services, shall establish a donor milk awareness program to—
“(1) educate the public on donor milk and nonprofit milk banks; and
“(2) publicize the need for donor milk at nonprofit milk banks.
“(b) Conduct of program—In carrying out the program described in subsection (a), the Secretary may—
“(1) develop or assist others to develop appropriate educational materials, including public service announcements, promotional publications, and press kits for the program described in subsection (a);
“(2) publish information about the program described in subsection (a) on the Department’s website; and
“(3) distribute or assist other to distribute such materials appropriate for public and private individuals and entities.
“(c) Cooperative agreements—The Secretary is authorized to enter into cooperative agreements with Federal agencies, State and local governments, and other entities to carry out the program described in subsection (a).
“(d) 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.
“(e) Authorization of appropriations—For purposes of carrying out this section, there are authorized to be appropriated $1,000,000 for fiscal year 2023, and such sums as may be necessary for each fiscal year thereafter.”
Sec. 7 CDC public awareness campaign with respect to donor milk from nonprofit milk banks
In general— The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall expand and intensify the activities of the Centers to include a public awareness campaign with respect to donor milk from nonprofit milk banks.
Distribution of educational materials— The public awareness campaign under subsection (a) shall include the distribution of educational materials to—
clinicians, such as pediatric specialists, pediatricians, obstetricians, pediatric nutritionists, midwives, and lactation specialists; and
expecting and new parents.
Sec. 8 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, acting through the Commissioner of Food and Drugs, shall issue a rule 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, acting through the Commissioner of Food and Drugs, shall submit to Congress a report specifying the regulatory categorization of donor milk provided by a nonprofit milk bank under the rule issued under subsection (a).