H.R. 8545 — Access to Donor Milk Act of 2026

This section defines key terms for purposes of the Act, including donor human milk as human milk collected, pasteurized, and dispensed without additives; donor human milk-derived product as a specialty nutritional product made predominantly from donor human milk with components removed or added; donor human milk bank as an organization meeting FDA safety standards that collects, tests, processes, pasteurizes, and distributes such milk or products in compliance with applicable law; and nonprofit donor human milk bank as a donor human milk bank that qualifies as a tax-exempt organization under section 501(c)(3) of the Internal Revenue Code.

This section expands allowable activities under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to include support for donor human milk (as defined in section 2 of the Access to Donor Milk Act of 2026) activities. This section also authorizes State agencies to use WIC funds for collecting and storing donations of unprocessed human milk and transferring such milk to nonprofit donor human milk banks (as defined in section 2 of the Access to Donor Milk Act of 2026).

This section establishes a competitive grant program under which the Secretary of Health and Human Services awards funds to nonprofit donor human milk banks to expand emergency capacity for collecting, processing, and distributing donor human milk. Grants may be awarded only upon a presidential declaration of a major disaster or emergency, a public health emergency declared by the Secretary, or a Secretarial determination that expanded capacity is needed to meet demand, particularly for high-risk infants. Authorized uses include publicizing the need for donor human milk, raising awareness among families, covering collection, storage, pasteurization, and processing fees, increasing staffing and supplies, purchasing consumables, and acquiring safety and quality equipment. The program is authorized at $3,000,000 for fiscal year 2026 and such sums as may be necessary for each fiscal year thereafter.

This section directs the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to develop a public awareness campaign on the benefits and safety of donor human milk from donor human milk banks and authorizes the Secretary to work with nonprofit donor human milk banks. The campaign must distribute educational materials to clinicians such as pediatric specialists, pediatricians, obstetricians, pediatric nutritionists, midwives, and lactation consultants; expectant and new parents, with a focus on those participating in the special supplemental nutrition program for women, infants, and children (WIC) under section 17 of the Child Nutrition Act of 1966; and community-based organizations.

This section directs the Secretary of Health and Human Services to convene a public meeting not later than 180 days after the date of enactment to assist in establishing minimum safety standards for donor human milk and donor human milk-derived products. The section further requires the Secretary to issue draft guidance not later than 18 months after enactment that establishes minimum safety standards for the collection, preparation, storage, handling, processing through pasteurization, and transfer of donor human milk and donor human milk-derived products, while taking into account unique factors related to such products, ethical considerations, protection of the United States donor milk supply, and resources available to non-profit milk banks.