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

The bill titled "Access to Donor Milk Act of 2026" aims to enhance the availability and safety of donor human milk in the United States. Here’s an overview of its key provisions:

Definitions

The bill outlines several key definitions relevant to the legislation:

• Donor human milk: Milk collected, pasteurized, and dispensed without additives.
• Donor human milk-derived product: Products primarily made from donor human milk, with components removed or added to create specialty nutritional products.
• Donor human milk bank: An organization that meets FDA standards for creating and distributing donor human milk safely, including collection and testing processes.
• Nonprofit donor human milk bank: A donor human milk bank that is tax-exempt under the Internal Revenue Code.

Support for Donor Human Milk Activities

The bill amends the Child Nutrition Act of 1966 to incorporate support for donor human milk activities. This includes:

• States may use federal funds for collecting, storing, and transferring unprocessed human milk to nonprofit donor human milk banks.

Emergency Capacity Funding for Human Milk Banks

The Secretary of Health and Human Services is authorized to award grants to expand the emergency capacity of donor human milk banks. Key points include:

• Funding to be provided only in response to major disasters or public health emergencies.
• Funds can be used for awareness campaigns about donor human milk, covering processing fees, increasing staffing, and purchasing necessary equipment.
• A total of $3 million is authorized for fiscal year 2026, with provisions for additional funding in subsequent years.

Public Awareness Campaign

The Secretary of Health and Human Services is required to develop a public awareness campaign focused on the benefits and safety of donor human milk. This includes:

• Distribution of educational materials to healthcare professionals and expectant/new parents, particularly those in the WIC program.

Regulatory Status of Donor Human Milk

The Secretary is tasked with establishing safety standards for donor human milk and related products through:

• A public meeting to discuss safety standards and considerations.
• Drafter guidance on minimum safety standards for collection, preparation, storage, and transfer of donor human milk within 18 months of enactment.

Relevant Companies

• ABT (Abbott Laboratories): Abbott produces various nutritional products, including infant formulas. Changes in donor milk availability could influence their product offerings and market strategy.
• PMCH (PMV Pharmaceuticals, Inc.): This company's operations may intersect with donor milk supply chains or nutrition product markets, potentially affecting their business landscape.