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FDA extends comment period for animal drug withdrawal times

FDA extends comment period on transit times, milking frequency and interpretation of zero-day withdrawal periods and zero-day milk discard times for animal drugs.

On Sept. 11, the Food & Drug Administration extended the comment period for its request for public input on transit times to slaughter facilities, milking frequency and interpretation of zero-day withdrawal periods and zero-day milk discard times for animal drugs. The comment period will now close on Jan. 6, 2020.

FDA originally announced its public comment request Aug. 8 for several key issues aimed at ensuring that its procedures for assigning withdrawal periods for animal drugs intended for use in food-producing animals adequately take into consideration current industry practices.

The agency is requesting public input on: (1) industry practices regarding how long it takes to transport certain food-producing animals from production facilities to slaughter facilities; (2) how frequently dairy animals are milked, and (3) how end users, such as animal producers or veterinarians, interpret animal drug labeling that states that the drug has a “zero-day withdrawal period” or “zero-day milk discard time” -- terms that indicate that an animal’s meat or milk is allowed to enter the food chain regardless of how much time has passed since the animal was last given the drug.

The agency said it is accepting public comments on these topics for all food-producing animals except laying hens, honeybees and food-producing aquatic animals because the concept of practical zero withdrawal does not apply to these classes of food-producing animals.

To electronically submit comments to the docket, visit www.regulations.gov, and type FDA-2019-N-3019 in the search box.

To submit comments to the docket by mail, include Docket Number FDA-2019-N-3019 on each page of the written comments, and send them to the following address:

Dockets Management Staff


Food & Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

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