In this file:
· FDA Media Release: FDA Requests Comments on Transit Times to Slaughter Facilities, Milking Frequency and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times for Animal Drugs
· Scientists Work to Address Challenges Related to Transporting Weaned Pigs
FDA Requests Comments on Transit Times to Slaughter Facilities, Milking Frequency and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times for Animal Drugs
Source: FDA Center for Veterinary Medicine
August 8, 2019
The U.S Food and Drug Administration (FDA) is requesting public comment on 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 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.
New animal drugs are assigned withdrawal periods and milk discard times when they are approved for use in food-producing animals. The withdrawal period or milk discard time is the interval between the last time the animal received a drug and the time when the animal can be slaughtered for human food or the milk can be consumed by people, respectively. If established withdrawal periods and milk discard times are appropriately followed, any drug residues present are expected to be safe for people to eat. In most cases, the FDA assigns a zero-day withdrawal period or zero-day milk discard time to new animal drugs when data or information demonstrate that edible tissues or milk can be consumed within time points known as “practical zero” withdrawal or milk discard.
Since the 1980s, the FDA has defined practical zero withdrawal as six hours for poultry and 12 hours for cattle and pigs, and practical zero milk discard as 12 hours for lactating dairy cows. The FDA currently assigns a zero-day withdrawal period or zero-day milk discard time to new animal drugs if data from scientific studies or other available information confirm that the amount of the drug remaining in edible tissues or milk from treated animals is safe for people to eat six hours after the last dose for poultry or 12 hours after the last dose for cattle, pigs, sheep, and goats.
The FDA recognizes that the animal agriculture industry has undergone significant changes since the 1980s when the current assumptions about transit time to slaughter and milking frequency were formulated. The agency has no indication of any new safety concerns: in fact, the number of drug residue violations detected by USDA at slaughter and reported to FDA has been trending downward since 2013. Instead, the FDA is seeking information about current industry practices and the end user’s interpretation of labeling statements. This information will help the FDA update its procedures, as necessary, to ensure that current industry practices are being appropriately considered.
The agency is accepting public comments on these topics for all food-producing animals except laying hens, honey bees, and food-producing aquatic animals because the concept of practical zero withdrawal does not apply to these classes of food-producing animals.
The FDA is accepting public comments for 60 days from the date of publication in the Federal Register. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2019-N-3019 in the search box. For assistance in submitting electronic comments, please see Regulations.gov Help.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2019-N-3019 on each page of your written comments.
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Comments will be accepted at any time, but should be submitted no later than October 8, 2019, to ensure that the FDA takes the information into consideration before making further decisions on this issue.
After the close of the comment period, the FDA will review the docket and consider the submitted comments to determine if the agency’s current approach to assigning zero-day withdrawal periods and zero-day milk discard times to new animal drugs is appropriate.
For more information:
Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs; Request for Comments
From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.
document, plus links
Scientists Work to Address Challenges Related to Transporting Weaned Pigs
Dr. Yolande Seddon - Western College of Veterinary Medicine
Farmscape for August 7, 2019
Canadian scientists are conducting research aimed at improving the comfort of weaned pigs during transport.
To help address challenges when transporting weaned pigs and provide information to support discussions related to regulatory changes scientists with the Prairie Swine Center, the Western College of Veterinary Medicine and the University of Guelph are studying the movement of weaned pigs from western to eastern Canada.
Dr. Yolande Seddon, an assistant professor in swine behavior and welfare with the Western College of Veterinary Medicine and NSERC Industrial Research Chair in Swine Welfare, says, as a result of factors such as entering a new environment, changes in temperature, road conditions and time of travel, recently weaned pigs faced added stresses.
Clip-Yolande Seddon-Western College of Veterinary Medicine:
Initially these trials are specifically trying to look at transportation of weaned pigs for short durations and long durations that would go up to the previous maximum allowable transport times and then to see how the pigs cope with this.
So what are the physiological and behavioral measures of stress, measures of dehydration, measures of fatigue, seeing how they behave on the truck, are they comfortable resting, is there evidence that they are too hot or trying to stabilize themselves or showing discomfort and then, when they arrive at the receiving barn, how quickly do they transition onto food and what is the mortality.
Really this initial research is trying to get data from commercial practices and just seeing how the animals are responding to the existing practices and it would be able to identify if there was a cause for concern or what the risk factors are for mortality.