DONOR Milk Act

Rosa L. DeLauro

Democrat · CT · Representative

Source: Congress.gov · FEC

• Chris Pappas (D-NH-1)Original· 2026-05-21
• Jefferson Van Drew (R-NJ-2)Original· 2026-05-21
• Lori Trahan (D-MA-3)Original· 2026-05-21
• Madeleine Dean (D-PA-4)Original· 2026-05-21
• Morgan McGarvey (D-KY-3)Original· 2026-05-21
• Eleanor Holmes Norton (D-DC)· 2026-06-09

Referred to the House Committee on Energy and Commerce.

2026-05-21

Source: Congress.gov

The federal government would establish new safety standards and oversight rules for pasteurized donor human milk, which is used in hospitals and by families with newborns and infants. The measure would require facilities that process and distribute this milk to follow stricter safety protocols and reporting requirements to prevent contamination and ensure the product meets quality standards. This would primarily affect milk banks, hospitals, and families who rely on donor milk for infants who cannot be breastfed.

AI-assisted summary generated from the official bill metadata (title, subjects, actions) sourced from Congress.gov. Cached and reviewed. Always verify against the official text linked below.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 8964 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 8964 To improve the safety of pasteurized donor human milk and enhance regulation. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES May 21, 2026 Ms. DeLauro (for herself, Mrs. Trahan, Mr. Van Drew, Mr. Pappas, Ms. Dean of Pennsylvania, and Mr. McGarvey) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To improve the safety of pasteurized donor human milk and enhance regulation. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Developing Oversight for Nutrition through the Official Regulation of Milk Act'' or the ``DONOR Milk Act''. SEC. 2. REGULATION OF PASTEURIZED DONOR HUMAN MILK. (a) Definitions.--Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended-- (1) in subsection (ss)-- (A) in paragraph (1), by striking ``or'' at the end; (B) in paragraph (2), by striking the period at the end and inserting ``; or''; and (C) by adding at the end the following: ``(3) pasteurized donor human milk.''; and (2) by adding at the end the following: ``(tt) 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.''. (b) Clarification of Food Manufacturer Registration Requirement.-- Section 415(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d(c)(1)) is amended by adding at the end the following: ``Beginning on the date of the enactment of the DONOR Milk Act, a food establishment that manufactures, processes, packs, or holds critical foods shall not be considered a 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''. (c) Annual Inspections of Donor Human Milk Manufacturers.--Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the following: ``(n) 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.''. (d) Compliance Grants for Donor Human Milk Manufacturers.--Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (c) of this section, is further amended by adding at the end the following: ``(o) 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. ``(2) Authorization of appropriations.--There are authorized to be appropriated $8,000,000, to remain available until expended, to carry out paragraph (1).''. <all>

• HR4647Captain Paul W. Bud Bucha VA Medical Center Act of 2025
  Passed House · 2026-07-16
• HR9458Wage Theft Prevention and Wage Recovery Act
  Referred to Committee · 2026-06-25
• HR9347CHILD Labor Act
  Referred to Committee · 2026-06-18
• HR9015Physician Education for Fistula Treatment Act
  Referred to Committee · 2026-05-22