Access to Donor Milk Act of 2023

The Access to Donor Milk Act of 2023 aims to protect and expand access to pasteurized, donor human milk. It defines key terms, amends existing law to support donor milk activities, establishes emergency capacity grants for milk banks, creates a public awareness campaign, and directs the development of regulatory guidance.

Sec. 2, Definitions: Defines 'donor human milk' as human milk collected, pasteurized, and dispensed without additives. Defines 'donor human milk bank' as an organization meeting FDA standards and legally collecting, testing, processing, pasteurizing, and distributing donor milk. Defines 'nonprofit donor human milk bank' as a donor milk bank that is a tax-exempt 501(c)(3) organization.

Sec. 3, Support for donor human milk activities: Amends the Child Nutrition Act of 1966 to include support for donor human milk activities in promotion efforts and allows state agencies to use funds for collecting and storing unprocessed human milk and transferring it to a nonprofit donor milk bank registered with the FDA.

Sec. 4, Emergency capacity funding for human milk banks: Directs the Secretary of Health and Human Services to award competitive grants to eligible entities (nonprofit donor milk banks registered with the FDA that show rapid demand increase or supply shortage) for expanding emergency capacity. Uses may include publicizing need, raising awareness, covering processing fees, increasing staffing, purchasing supplies, and acquiring equipment. Grants are authorized only during major disasters, public health emergencies, or when federal assistance is needed to supplement state and local efforts. Authorizes $3,000,000 for fiscal year 2024 and necessary sums thereafter.

Sec. 5, Public awareness campaign with respect to donor human milk: Requires the Secretary, through HRSA, to develop a public awareness campaign on the benefits and safety of donor milk from FDA-registered banks, and encourages working with nonprofit FDA-registered banks. The campaign must distribute educational materials to clinicians, expectant and new parents (especially those in the WIC program), and community-based organizations.

Sec. 6, Regulatory status of donor human milk: Requires the Secretary to convene a public meeting within 180 days of enactment to inform draft guidance. Within 18 months, the Secretary must issue draft guidance addressing standards for collection, preparation, storage, handling, pasteurization, and transfer of donor milk and donor milk-derived products, and consider the appropriateness of screening and other processes.