DONOR Milk Act (H.R. 8964)

Summary

Makes rules for donated human milk to ensure it is safe for babies by requiring inspections and giving money to milk banks to meet safety standards.

What problem does this solve?

Donated human milk lacks federal safety rules, which can be risky for the vulnerable infants who need it. This bill gives the FDA authority to inspect milk banks and helps them meet safety standards with grants.

What does this bill do?

Defines donor human milk as a critical food

Adds 'pasteurized donor human milk' to the list of critical foods regulated by the Federal Food, Drug, and Cosmetic Act. This gives the FDA clear authority over it.

Requires annual inspections of milk banks

Directs the government to inspect every facility that makes, processes, or stores donor human milk at least once a year. These inspections will help ensure the milk is safe.

Removes registration exemption for milk banks

Clarifies that nonprofit milk banks must register with the government as food facilities. They can no longer use an exemption meant for places that serve food directly to people.

Provides grants to help milk banks comply

Authorizes $8 million for grants to nonprofit donor milk banks. This money will help them pay for equipment upgrades and other costs to meet the new safety rules.

Who does this affect?

Infants receiving donor milk
Nonprofit human milk banks
Mothers who donate milk

What is the real world impact?

•

Increases safety for vulnerable infants

Establishes clear federal rules and inspections for donor human milk banks. This ensures that the milk given to premature or sick babies is safe and properly handled.

•

Places new requirements on milk banks

Requires nonprofit milk banks to register with the FDA and undergo annual inspections. While grants are provided, some may argue this adds a financial and administrative burden to organizations that provide a vital service.

When does this start?

This bill sets specific deadlines for its new rules to take effect after it becomes law.

Registration for Milk Banks

Nonprofit milk banks will be required to register as food facilities starting on the day the bill is signed into law.

Annual Inspections

The government must begin conducting annual inspections of donor milk facilities within one year of the bill becoming law.