The agency on Wednesday issued a request to the public for comments on a risk assessment on residues in dairy products, which was conducted as part of a larger effort to work with industry and state partners to improve the 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 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 dairy product 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 on regulations.gov under docket FDA-2015-N-1305.