The U.S. Food and Drug Administration (FDA) published a series of three documents in the Federal Register today as part of an effort to alter the use of antibiotics in food-producing animals.
In a statement prior to today’s publication, FDA indicated that the issuance of three new documents will help veterinarians, farmers and animal producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems. Under a new voluntary initiative, certain antibiotics would not be used for so-called “production” purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian. There will be a three-year "phase in" period before these changes will become effective, but the exact dates of the phase-in period currently remain unspecified.
“It’s critical that we take action to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”
The three documents published in today’s Federal Register include:
· A final guidance for the industry, Guidance 209, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals," that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
· A draft guidance, Draft Guidance 213, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control and treatment uses; and changing the marketing status to include veterinary oversight.
· A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.
FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents are meant to describe the FDA’s current thinking on a topic. As the American Association of Swine Veterinarians pointed out in a news release, it should be noted that FDA intends to work with drug manufacturers to remove label indications for growth promotion and feed efficiency from products considered important for human health. Once these products are no longer labeled for production uses, it will be illegal for veterinarians or producers to utilize medicated feeds for these purposes.
The National Pork Producers Council (NPPC) is concerned that lost and restricted access to antimicrobial products expected to result from these steps likely will disproportionately affect small producers, have a negative effect on animal health, and increase the cost of producing food while not improving public health. NPPC makes the point that this action is a move to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on the use of antibiotics in livestock and poultry production.
However, numerous peer-reviewed risk assessments, including at least one by FDA, show a “negligible” risk to human health of antibiotics in food-animal production, according to NPPC.
Tom Talbot, a California beef producer, veterinarian and current chairman of the National Cattlemen’s Beef Association (NCBA) Cattle Health and Well-Being Committee, issued a statement that raises key points on this issue. “Antimicrobial resistance is a multifaceted, extremely complex issue that cannot be adequately addressed solely by focusing on the use of antibiotics in animal agriculture. Prudent and responsible evaluation of this issue must consider animal, human and industrial use of antibiotics. While we appreciate the agency working with industry on the implementation of Guidance 209, we remain committed that a strong science foundation is critical before moving forward with this guidance,” he states.
John Clifford, DVM, USDA Chief Veterinary Medical Officer, says, "USDA worked with FDA to ensure that the voices of livestock producers across the country were taken into account, and we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition."
FDA is currently accepting comments on Draft Guidance 213 and on the Veterinary Feed Directive document. Submit comments on these documents by the date provided in the Federal Register notice announcing the availability of the Draft Guidance (July 12, 2012). Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
Learn more at the FDA Web site at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm299802.htm. A Question and Answer Document has been prepared by FDA on this topic at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm.