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NMPF Submits Comments to Zero-Day Withdrawal Antibiotic Docket

February 4, 2020

NMPF highlighted the United States dairy industry’s commitment to antimicrobial stewardship, citing a large reduction in milk residues and closer relationships with veterinarians in comments submitted Jan. 6 to a docket opened by the Food and Drug Administration requesting information on zero-day withdrawal antibiotic usage.

The docket requested information regarding current milking frequencies and how zero-day withdrawal antibiotics are interpreted by U.S. dairy farmers. The industry participated in the Antimicrobial Resistance Challenge and has made the veterinary-client-patient-relationship a cornerstone of the National Dairy FARM Program, emphasizing the dedication of dairy farmers to the judicious use of antibiotics, which has led to lower detection of antibiotic residues in milk tankers. For example, in 1996, 0.104 percent of bulk milk pick-up tankers tested positive for a drug residue. By 2019, that rate had fallen more than 90 percent, to just 0.009 percent of bulk milk pick-up tankers.

NMPF answered two questions asked by FDA:

  1. What milking frequencies do United States commercial dairy operations commonly use (e.g., two times per day, three times per day, greater than three times per day)? To what extent is each milking frequency used nationally, regionally, or within a particular sector (e.g., 25 percent of dairies nationally, 30 percent of dairies in the Midwest, 50 percent of dairies serviced by a veterinary practice, etc.)?
  2. How do end users of new animal drugs interpret labeling that has a “zero-day withdrawal period” or “zero-day milk discard time,” or that states “no withdrawal period or milk discard time is required”?”

NMPF analyzed FARM data and conducted a survey in that received more than 100 responses to answer the questions. NMPF pointed out that FDA’s request may have reached only a small set of dairy farmers, making it important to use several data sources.  The U.S. dairy industry is committed to producing the highest quality, safe, abundant and affordable milk and dairy beef.

NMPF supports FDA-CVM periodically consulting with the dairy industry to ensure that the data packages generated to support the safety and effectiveness of veterinary medicinal products reflect current industry practices.