FDA calls for public comment on new rules for animal antibiotics use


By Jon H. Harsch

© Copyright Agri-Pulse Communications, Inc.

Washington, June 30 – The running battle over the livestock industry's routine, non-therapeutic use of antibiotics intensified this week with a warning from the U.S. Food and Drug Administration (FDA) that “the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production or growth enhancing purposes (i.e., non-therapeutic or sub-therapeutic uses) in food-producing animals is not in the interest of protecting and promoting the public health.”


The FDA's “Draft Guidance on the Judicious Use of Medically Important Antimicrobials in Food-Producing Animals” acknowledges “the efforts to date by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs.” But the FDA report concludes that “additional steps are needed” – including “phasing in measures that would limit medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation.”


Due to continuing concern that animal antibiotics use may be a significant contributing factor to increasing resistance to antibiotics in the human population, FDA finds that “These steps would help reduce overall use of medically important antimicrobial drugs, thereby reducing the pressure that generates antimicrobial resistance.”


Rep. Louise Slaughter (D-NY), a long-time proponent of limiting antibiotics use for livestock production and author of H.R. 1549, the Preservation of Antibiotics for Medical Treatment Act, welcomed the new FDA guidance. But she warned that the FDA's latest proposals “have not gone far enough or moved fast enough.”


The National Pork Producers Council (NPPC), however, warns that the FDA proposals “could lead to the elimination or costly review of previously approved animal health products.” According to the NPPC, “there appears to be no science on which FDA based the guidance.”


NPPC President Sam Carney charges that “This guidance could eliminate certain antibiotics that are extremely important to the health of animals. FDA didn’t present any science on which to base this, yet it could have a tremendous negative impact on animal health and, ultimately, the safety of food. As we know, healthy animals produce safe food, and we need every available tool to protect animal health.”


The National Cattlemen's Beef Association (NCBA) also weighed in, commenting that “Antimicrobial resistance is a multi-faceted and extremely complex issue that cannot be adequately addressed by solely focusing on the use of these medications in animal agriculture. Only by carefully evaluating antimicrobial resistance in a comprehensive manner that evaluates all of the peer-reviewed science related to all animal use, human use and industrial use will we effectively address this important issue.”


With the FDA guidance simply recommending changes and providing a 60-day public comment period, NCBA concludes that it “will carefully review this draft guidance and the reports cited as the basis of their reasoning for their framework for policy on this issue. NCBA supports actions based only on sound, peer-reviewed science and risk assessment relative to the use of antibiotics. More clarity is needed in definitions related to many of the concepts in this document, and we look forward to continuing to provide input to FDA.” NCBA adds that “As FDA officials seek stakeholder input, we encourage them to go out and visit farms and ranches to see firsthand how our producers are utilizing antimicrobials and working with their veterinarians to keep cattle healthy and ensure safe and wholesome beef.”


To read the FDA's 19-page report on “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” go to: www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf. For related FDA documents including links to the Federal Register Notice and “Questions and Answers” go to: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217464.htm. To submit comments by FDA's Aug. 30 deadline, go to http://www.regulations.gov/ or address written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Preface your comments with “Docket No. FDA–2010–D–0094.”


To return to the News Index page, click: www.agri-pulse.com