This bill, the DONOR Milk Act, regulates pasteurized donor human milk as a critical food by requiring annual safety inspections for processing facilities and providing grants to help nonprofit milk banks meet food safety standards.
Rosa DeLauro
Representative
CT-3
The DONOR Milk Act aims to enhance the safety and oversight of pasteurized donor human milk by regulating it as a critical food under federal law. This legislation mandates annual safety inspections for all processing facilities and requires them to register as food establishments. Furthermore, it establishes a grant program to assist nonprofit milk banks in meeting these new food safety standards.
DONOR Milk Act Sets New Safety Standards and Annual Inspections for Human Milk Banks
The DONOR Milk Act introduces a significant shift in how donated human milk is handled in the United States by officially classifying it as a “critical food” under the Federal Food, Drug, and Cosmetic Act. This change puts donor milk in a special category of essential nutrition, similar to infant formula, which triggers stricter oversight. Specifically, the bill targets pasteurized donor human milk—milk donated by one mother for another’s infant—and ensures it is collected, processed, and dispensed without extra additives. By formalizing this definition in Section 2, the bill creates a clear regulatory baseline for a product that is often a lifeline for premature infants or families facing medical challenges.
New Rules for the Milk Bank
To ensure safety, the legislation removes a previous loophole that allowed some nonprofit facilities to skip formal registration. Under Section 415(c)(1), nonprofit milk banks will no longer be exempt from registering as food establishments, even if they serve consumers directly. This means every facility that processes or packs donor milk must be on the grid and accountable. Furthermore, the bill mandates that the Secretary of Health and Human Services conduct annual, unannounced inspections of these facilities. For a local nonprofit milk bank, this means transitioning from a relatively self-regulated environment to one with yearly professional audits to check compliance with food safety and labeling laws.
Funding the Upgrade
Recognizing that new regulations can be expensive, especially for nonprofits, the bill authorizes $8,000,000 in grants to help these facilities catch up. According to the grant provisions, these funds can be used for physical equipment upgrades, obtaining new safety certifications, or hiring third-party experts for food safety consultations. For example, a small regional milk bank that needs to modernize its pasteurization equipment to meet the new federal standards could apply for these funds to cover the costs. This financial cushion is designed to ensure that the push for higher safety standards doesn't accidentally force smaller, essential nonprofit banks to close their doors due to compliance costs.