HB8964, the DONOR Milk Act, would amend the Federal Food, Drug, and Cosmetic Act to create a clearer federal regulatory framework for pasteurized donor human milk. The bill defines “pasteurized donor human milk” in statute as donated human milk that has been collected, pasteurized, and dispensed without additives, and it adds that category to the Act’s definitions so it can be regulated more directly as a food product.
The bill also clarifies that facilities that manufacture, process, pack, or hold critical foods, including donor human milk, are not exempt from food establishment registration requirements as nonprofit food service operations. In addition, it requires the Secretary of Health and Human Services to conduct annual, risk-based inspections of donor human milk facilities, including unannounced inspections, to ensure compliance with food safety and labeling rules. Finally, it authorizes FDA to provide grants to nonprofit donor milk entities to help them comply with the new requirements, including equipment upgrades, certifications, and third-party food safety consulting, with $8 million authorized for that purpose.
If enacted, the bill would expand federal oversight of pasteurized donor human milk by bringing it more explicitly within FDA’s food safety and registration framework. It would affect nonprofit milk banks and other entities that process donor milk by subjecting them to annual inspections, registration-related obligations, and compliance expectations under the Federal Food, Drug, and Cosmetic Act. The bill would also create a new federal grant program to help eligible nonprofit entities meet those standards, potentially reducing compliance burdens for smaller organizations while increasing regulatory uniformity nationwide.
The available context suggests generally supportive sentiment, as the bill was introduced by multiple House members and framed around improving safety and oversight of donor human milk. There is no recorded committee debate or vote history in the provided materials, so no formal opposition or bipartisan split is documented here. The bill’s structure, which combines stricter regulation with compliance grants, suggests an effort to balance consumer safety with operational support for nonprofit milk banks.
The main potential point of contention is the level of federal regulation imposed on donor human milk facilities, especially nonprofit milk banks that may face new inspection, registration, and compliance costs. Some stakeholders may view the annual inspection requirement and the clarification of food establishment status as necessary to protect vulnerable infants, while others may worry about administrative burden, cost, or whether existing state and nonprofit standards are sufficient. The grant program appears designed to address those concerns, but the adequacy of the funding and which entities qualify could also become issues.