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
To improve the safety of pasteurized donor human milk and enhance regulation.
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).