Access to Donor Milk Act of 2026

The term donor human milk means human milk that is collected, pasteurized, and dispensed without additives.

The term donor human milk-derived product means a product made predominantly from donor human milk—

(A) from which one or more components has been removed in order to produce a specialty nutritional product; or

(B) to which one or more human milk or non-human milk components has been added to produce such a product.

The term donor human milk bank means an organization that—

(A) meets standards established by the Food and Drug Administration for purposes of ensuring the safety of donor human milk and human milk banks, including such standards as may be prescribed pursuant to section 6; and

(B) collects, tests, processes, pasteurizes, and distributes, in compliance with applicable Federal and State law, donor human milk or donor human milk derived products.

The term nonprofit donor human milk bank means a donor human milk bank that is an organization—

(A) described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)); and

(B) exempt from taxation under section 501(a) of such Code (26 U.S.C. 501(a)).

(1) in subsection (b)(4), by inserting (including support for donor human milk (as defined in section 2 of the Access to Donor Milk Act of 2026) 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:

A State agency may use amounts made available under clause (i) for—

(I) collecting and storing donations of unprocessed human milk; and

(II) the transfer of the milk described in subclause (I) to a nonprofit donor human milk bank (as defined in section 2 of the Access to Donor Milk Act of 2026).

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall award competitive grants, subject to subsection (c), to eligible entities for expanding emergency capacity with respect to banking donor human milk.

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.

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) or to any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d).

(2) The President makes a determination described in section 102(1) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5122(1)), or the Secretary makes such a determination.

(3) The Secretary determines emergency capacity is needed to ensure adequate supply is available to meet the demand for donor human milk from an eligible entity.

Expanding emergency capacity pursuant to a grant under this section may include—

(1) publicizing the need for donor human milk, especially for high-risk infants;

(2) raising awareness and providing resources to families, especially families of high-risk infants, about donor human milk;

(3) covering donor human milk collection, storage, pasteurization, transfer, and processing fees;

(4) increasing staffing and supplies needed at donor human milk banks;

(5) purchasing consumable products needed for donor human milk processing; and

(6) acquiring equipment for safety and quality processing of donor human milk.

For purposes of this section, the term eligible entity means an entity that—

(1) is a nonprofit donor human milk bank; and

(2) in the application submitted under subsection (b), demonstrates, with respect to such entity—

(A) a rapid increase in demand for donor human milk; or

(B) a shortage of supplies needed to operate a donor human milk bank.

For the purposes of carrying out this section, there are authorized to be appropriated $3,000,000 for fiscal year 2026, and such sums as may be necessary for each fiscal year thereafter.

The Secretary of Health and Human Services—

(1) shall, acting through the Administrator of the Health Resources and Services Administration, develop a public awareness campaign with respect to the benefits and safety of donor human milk from donor human milk banks; and

(2) may work with nonprofit donor human milk banks.

The public awareness campaign under subsection (a) shall include the distribution of educational materials to—

(1) clinicians, such as pediatric specialists, pediatricians, obstetricians, pediatric nutritionists, midwives, and lactation consultants, including international board-certified lactation consultants;

(2) expectant and new parents, with a focus on expectant and new parents that are participating in the special supplemental nutrition program for women, infants, and children program under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786); and

(3) community-based organizations.

Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall, for purposes of assisting the Secretary in establishing minimum safety standards for donor human milk and donor human milk-derived products under subsection (c), convene a public meeting.

In establishing the safety standards under subsection (c), the Secretary shall take into account—

(1) the unique factors related to donor human milk and donor human milk-derived products;

(2) ethical considerations;

(3) the protection of the United States donor milk supply; and

(4) the resources available to non-profit milk banks.

Not later than 18 months after the date of enactment of this Act, the Secretary shall issue draft guidance that—

(1) establishes minimum appropriate safety standards for the collection and preparation, storage, handling, and processing through pasteurization, and transfer of donor human milk and donor human milk-derived products; and

(2) considers the minimum appropriateness of screening, testing, and other processes, to ensure the safety of donor human milk and donor human milk-derived products, as determined by the Secretary.