FDA Seeks Public Comment on Risk Assessment of Drug Residues in Milk and Milk Products

Constituent Update

April 29, 2015

In the agency’s efforts to support openness and transparency, the FDA is seeking public comment on a risk assessment of drug residues in milk and milk products. The risk assessment was conducted as part of the overall effort to continuously work with industry and state partners to improve an already strong and effective regulatory system for milk and milk products.

The FDA approves drugs for use in food-producing animals only when the data show there is a reasonable certainty of no harm to human health from the proposed use. As part of the drug approval process, the FDA establishes tolerance levels (levels considered safe) for veterinary drug residues in food. After a cow is treated with a drug, milk from that cow is to be discarded for the time established by the FDA to assure that the milk is safe for human consumption. If illegal drug residues are present, milk from a cow being treated with a drug cannot be sold for human consumption.

As part of the FDA’s science-based approach to food safety, the assessment considered a wide range of data and information, including government conducted surveys, the published literature, and input through external peer review. The model reviewed four overarching criteria that collectively contribute to a drug’s ranking:

  • the likelihood that the drug will be administered to lactating dairy cows;
  • the likelihood that, following administration, drug residues would be present in bulk milk;
  • the relative extent to which consumers could be exposed to the drug residue by drinking or eating milk and milk products; and
  • the potential for a human health hazard given exposure to the drug residue.

The FDA is accepting public comments beginning on April 30, 2015. To electronically submit comments to the docket, visit and type FDA-2015-N-1305 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2015-N-1305 on each page of your written comments.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

Page Last Updated: 04/29/2015
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