DeLauro, Trahan Introduce Bipartisan DONOR Milk Act

WASHINGTON - Today, U.S. Representatives Rosa DeLauro (D-CT-03) and Lori Trahan (D-MA-03) introduced the Developing Oversight for Nutrition through the Official Regulation of Milk Act or the DONOR Milk Act, legislation that would better protect the nation's supply of donor human milk - a lifesaving resource for premature and medically fragile newborns. The legislation is introduced in honor of World Donor Milk Day, which is May 19.

Hundreds of lawsuits in the United States now allege that preterm infant formula could be associated with a higher risk of a serious gastrointestinal illness, necrotizing enterocolitis (NEC). More must be done to make donor human milk safer and more accessible.

Donor human milk is the gold standard for premature and critically ill infants when a mother's own milk is unavailable. One factor that is proven to reduce the development of NEC in premature and medically fragile newborns infants is the use of human milk. However, there must be proper federal oversight and requirements to ensure the stability of this Critical Food, as well as better coverage for it.

"We must ensure the food we feed our babies is high quality and safe," said Congresswoman DeLauro. "The donor milk industry is growing, and the DONOR Milk Act treats this growing industry with the seriousness it deserves - as a Critical Food vital to lifting up the next generation. This bipartisan legislation would put commonsense safeguards in place to protect newborns, and I am proud to it alongside my colleagues and with the support of milk banks across the country."

"Premature babies and newborns in critical condition deserve the safest, highest-quality nutrition possible, and right now our federal oversight hasn't kept pace with the growing demand for donor human milk," said Congresswoman Lori Trahan. "The DONOR Milk Act closes that gap, ensuring that when a family is fighting for their baby's life, the safety of their nutrition is one less thing they have to worry about."

"Donor milk is one of the most powerful tools we have in ensuring optimal health for premature infants," said Scott Elster, CEO of Prolacta Bioscience. "But for too long, we have lacked a consistent set of safety standards to ensure the donor milk fed to our most vulnerable babies meets the quality required to remain contaminant free and support growth these babies need to thrive. The DONOR Milk Act will change that - and it will help make our babies healthier and stronger as a result. We are immensely grateful to Representatives DeLauro, Trahan, Van Drew, Pappas, and Dean for their leadership on this critical legislation and all of their efforts to establish safety standards for the fragile babies who need it most."

"Donor milk is a safe, evidence-based intervention that protects premature and low birth weight infants," said Lindsay Groff, Executive Director of HMBANA. "The DONOR Milk Act would strengthen regulatory clarity for donor milk while providing critical support for nonprofit milk banks. We appreciate the sponsors' focus on ensuring medically vulnerable infants can receive this care."

The DONOR Milk Act would:

• Designate donor human milk as a Critical food.
  • Which would require milks banks to notify the Secretary of Health and Human Services (HHS) of a discontinuance or interruption that is likely to lead to a disruption of supply not later than 5 days after such an incident occurs.
  • Which would also require each manufacture of a Critical Food to create a Risk Management Plan that:
    • Identifies/evaluate the risks of making more than one Critical Food at a facility.
    • Mechanisms by which a manufacturer would mitigate the impacts of a supply disruption.
• Subject donor milk banks to annual inspections by the Food and Drug Administration (FDA)
• Include an authorization of appropriations (up to $8 million) to assist non-profit milk banks comply with the legislation to not affect or harm supply.

Along with co-leads U.S. Representatives DeLauro and Trahan, the legislation is cosponsored by U.S. Representatives Jeff Van Drew (R-NJ-02) and Chris Pappas (D-NH-01).

Text of the legislation is available here.

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delauro.house.gov