HR 8964 — DONOR Milk Act

Bill Text

• Introduced Introduced in House Current html May 21, 2026

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds new definitions and regulatory requirements specifically for pasteurized donor human milk and modifies existing registration and inspection processes for food manufacturers.

• 21 U.S.C. 321

  (3) pasteurized donor human milk.

  This adds 'pasteurized donor human milk' as a defined term under the Federal Food, Drug, and Cosmetic Act.

• 21 U.S.C. 321

  The term 'pasteurized donor human milk' means human milk which-- (1) is expressed by a mother and donated for use by a recipient that is not the mother's own infant; and (2) has been collected, pasteurized, and dispensed without additives.

  This introduces a specific definition for pasteurized donor human milk, clarifying its composition and intended use.

• 21 U.S.C. 350d(c)(1)

  nonprofit food establishments in which food is prepared for or served directly to the consumer → nonprofit food establishments in which food is prepared for or served directly to the consumer and the exception in the preceding sentence shall no longer apply to such a facility

  This change clarifies the registration requirement for food establishments involved in critical food manufacturing, reinforcing that they cannot rely on the nonprofit exemption.

• 21 U.S.C. 350a

  Annual Inspections of Donor Human Milk Manufacturers.-- Beginning not later than 1 year after the date of the enactment of this subsection, and not less frequently than once each year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities of each entity that manufactures, processes, packs, or holds pasteurized donor human milk in accordance with a risk-based approach to ensure compliance with relevant food safety and food labeling requirements under this Act or any other provision of law administered by the Secretary.

  This mandates annual inspections of facilities that handle pasteurized donor human milk, enhancing oversight and ensuring compliance with safety standards.

• 21 U.S.C. 350a

  Compliance Grants for Donor Human Milk Manufacturers.-- (1) In general.--The Secretary shall make grants to nonprofit entities that manufacture, process, pack, or hold pasteurized donor human milk and are registered under section 415(c) to assist such entities in complying with this Act, including through assisting such entities with respect to making any upgrades in equipment, obtaining necessary certifications, and entering into contracts with third parties for food safety quality consultations.

  This establishes a grant program to support nonprofit manufacturers of pasteurized donor human milk in meeting compliance standards and improving their facilities.

• 21 U.S.C. 350a

  Authorization of appropriations.--There are authorized to be appropriated $8,000,000, to remain available until expended, to carry out paragraph (1).

  This provides funding for the compliance grants program for donor human milk manufacturers, ensuring financial resources for implementation.

Action History

1. May 21, 2026

   Introduced in House

2. May 21, 2026

   Introduced in House

3. May 21, 2026

   Referred to the House Committee on Energy and Commerce.

Sponsors

• Lori Trahan · Cosponsor
• Jefferson Van Drew · Cosponsor
• Chris Pappas · Cosponsor
• Madeleine Dean · Cosponsor
• Morgan McGarvey · Cosponsor
• Eleanor Holmes Norton · Cosponsor
• Michael Lawler · Cosponsor
• Suzanne Bonamici · Cosponsor
• Rosa L. DeLauro · Primary

Subjects