Access to Donor Milk Act of 2023

This bill aims to protect and expand access to pasteurized donor human milk. It defines key terms, amends existing law to support donor milk activities, creates an emergency grant program for milk banks, mandates a public awareness campaign, and requires 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 for safety and 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 nutrition promotion. Allows state agencies to use funds for collecting and storing unprocessed human milk donations and transferring that milk to a nonprofit donor human 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 a rapid increase in demand or supply shortage) for expanding emergency capacity. Use of funds may include publicizing need, raising awareness, covering processing fees, increasing staffing and supplies, purchasing consumables, 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 or ensure adequate supply. Authorizes $3,000,000 for fiscal year 2024 and necessary sums for each following year.

Sec. 5, Public awareness campaign with respect to donor human milk: Requires the Secretary, through the Health Resources and Services Administration, to develop a public awareness campaign on the benefits and safety of donor human milk from FDA-registered milk 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status of donor human milk: Requires the Secretary to convene a public meeting within 180 days of enactment to inform draft guidance. Within 18 months of enactment, the Secretary must issue draft guidance addressing standards for collection, preparation, storage, handling, pasteurization processes, and transfer of donor human milk and donor human-milk derived products, and considering the appropriateness of screening and other processes.