DONOR Milk Act
- Sponsor
- Rep. DeLauro, Rosa L. [D-CT-3]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- May 21, 2026
Bottom line
The bill aims to enhance the safety and regulatory oversight of pasteurized donor human milk by subjecting it to federal food safety standards, requiring regular inspections, and providing financial assistance for nonprofit compliance.
What it actually does
This bill, known as the "DONOR Milk Act," amends the Federal Food, Drug, and Cosmetic Act to classify pasteurized donor human milk as a "critical food." It mandates annual, unannounced, risk-based inspections of all facilities that manufacture, process, pack, or hold donor human milk, removing a previous nonprofit exemption from registration requirements. Additionally, it authorizes $8,000,000 in grants for nonprofit donor human milk manufacturers to assist with compliance costs, including equipment upgrades and certifications.
Proponents argue
Proponents argue that this legislation is crucial for safeguarding the health of vulnerable infants who rely on donor human milk by ensuring consistent, high-quality safety standards. They contend that formalizing federal oversight and providing compliance grants will professionalize the industry, build public trust, and prevent potential health risks associated with unregulated milk banking practices.
Opponents contend
No organized opposition is explicitly stated in the bill text. Potential critics might argue that increased federal regulation could impose undue administrative and financial burdens on smaller, nonprofit milk banks, potentially limiting access to donor milk if compliance costs become prohibitive, despite the availability of grants.
The bill is very short and straightforward, allowing for quick comprehension of its provisions and their immediate implications.
Section 1
Short Title
This section establishes the official short title of the Act as the "Developing Oversight for Nutrition through the Official Regulation of Milk Act" or the "DONOR Milk Act." This provides a common and concise name for referring to the legislation.
Supporters argue
Supporters argue that a clear and memorable short title is standard legislative practice, facilitating discussion and reference to the bill's purpose.
Critics contend
No specific opposition is typically raised against the naming of a bill.
Tradeoffs
None.
Section 2(a)
Definition of Pasteurized Donor Human Milk as a 'Critical Food'
This provision amends Section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include "pasteurized donor human milk" under the definition of "critical foods." It also formally defines "pasteurized donor human milk" as human milk expressed by a mother, donated for use by a recipient that is not the mother's own infant, and collected, pasteurized, and dispensed without additives.
Section 2(b)
Removal of Nonprofit Exemption for Donor Milk Manufacturers
This section clarifies Section 415(c)(1) of the FD&C Act, stating that food establishments manufacturing, processing, packing, or holding critical foods (which now includes pasteurized donor human milk) shall no longer be considered nonprofit food establishments exempt from federal registration requirements. This means all entities handling donor human milk, regardless of their nonprofit status, must register with the FDA.
Section 2(c)
Annual Inspections of Donor Human Milk Manufacturers
This section amends Section 412 of the FD&C Act by adding a new subsection (n), mandating that the Secretary (acting through the FDA) conduct annual, unannounced, risk-based inspections of all facilities that manufacture, process, pack, or hold pasteurized donor human milk. These inspections are required to begin no later than one year after the bill's enactment and occur at least once each year thereafter, ensuring compliance with relevant food safety and labeling requirements.
Section 2(d)
Compliance Grants for Donor Human Milk Manufacturers
This section further amends Section 412 of the FD&C Act by adding a new subsection (o), authorizing the Secretary to make grants to nonprofit entities that manufacture, process, pack, or hold pasteurized donor human milk and are registered under Section 415(c). These grants are intended to help these entities comply with the FD&C Act, specifically for equipment upgrades, necessary certifications, and contracts for food safety quality consultations. The bill authorizes $8,000,000 to be appropriated for this purpose, to remain available until expended.