Summary#
The DONOR Milk Act adds pasteurized donor human milk to the Federal Food, Drug, and Cosmetic Act. It defines "pasteurized donor human milk" as milk expressed by a mother, donated for use by someone other than the mother's own infant, and collected, pasteurized, and dispensed without additives. The bill removes a nonprofit exception so that food establishments that manufacture, process, pack, or hold certain "critical foods" are not excluded from food establishment registration requirements. The Secretary must begin annual inspections (including unannounced inspections) of facilities that manufacture, process, pack, or hold pasteurized donor human milk no later than one year after enactment, using a risk-based approach. The bill also directs the Secretary to make compliance grants to nonprofit entities that are registered under the registration provision to help them meet requirements (for example, equipment upgrades, certifications, or contracts for food safety consultations). The bill authorizes $8,000,000 to carry out those grants, to remain available until expended.
What it means for you#
- Facilities that pasteurize or handle donated human milk will be covered by a federal definition and must register under the amended registration rules.
- Those facilities will be inspected at least once a year by the federal agency that enforces the Federal Food, Drug, and Cosmetic Act, with some inspections unannounced. Inspections must follow a risk-based approach.
- Registered nonprofit milk banks and similar entities can apply for federal grants to help comply with the law (for example, for equipment or certifications).
- The inspection program must start no later than one year after the law is enacted.
Expenses#
- The bill authorizes $8,000,000, to remain available until expended, to fund compliance grants for nonprofit entities that handle pasteurized donor human milk.
- No publicly available information on other federal costs, savings, or budgetary effects is provided in the bill text.
Proponents' View#
- The bill’s stated purpose is "to improve the safety of pasteurized donor human milk and enhance regulation." It was introduced by Representatives Rosa DeLauro, Lori Trahan, Jefferson Van Drew, Chris Pappas, Madeleine Dean, Morgan McGarvey, and others. Supporters, as reflected by the bill text and title, seek stronger oversight, annual inspections, and grant help for compliance.
Opponents' View#
No publicly available information.