WASHINGTON, D.C. — A joint task force of three federal health agencies are finalizing plans to launch one of the most extensive on-farm site studies ever to investigate the use of antimicrobial drugs in food animals.
The investigation comes on the heels of a White House directive that established a National Action Plan to combat the "serious public health threat of drug-resistant bacterial infections" in the nation’s animal-food chain. Once the 12- to 18-month study is completed, the government’s objective is to issue mandatory restrictions and guidelines on the use of antimicrobial medicines on farm animals, effective Jan. 1, 2017.
Antimicrobial drugs include antibiotics, anti-fungals, anti-protozoals (to treat infections caused by various types of parasites) and anti-virals (to treat influenza). Many of the 2 million illnesses and 23,000 deaths the Centers for Disease Control and Prevention (CDC) log that are caused each year by drug-resistant bacteria are attributed to the overuse or misuse of drugs in farm animals, according to the U. S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine.
A team of top health officials from the CDC, FDA and USDA held a public meeting in Washington, D.C., Sept. 30 to outline the details and objectives of the massive farm data collection.
"Tracking the use of antibiotics is critical to knowing how we’re doing with stewardship," said Dr. Beth Bell, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases. "Good information about where, why and how animal antibiotics are used is the basic information needed to know when stewardship is going well."
Currently, on-farm drug data is collected on a limited basis and do not represent or provide sufficient detail to help inform antimicrobial stewardship, officials say. The study will target about 70 percent of farms that raise and produce dairy and beef cattle, poultry, turkey and boilers, and hogs in the food chain, on a "volunteer" basis.
The study’s goal is to limit the use of "medically important antibiotics" in food and water for "therapeutic purposes only" and farmers will be required to obtain prescription authorization to use antimicrobial drugs "only" from licensed veterinarians, according to Dr. William Flynn, deputy director for Science Policy at the Center of Veterinary Medicine (CVN).
He said the CVN will conduct inspections to ensure government oversight of animal drug usage that will also limit their use to enhance animal growth.
He outlined various sources of data needed to target antibiotic resistance: drug sales numbers, on-farm use, resistance trends in foodborne bacteria and animal demographics and health, with several FDA inspections at each volunteering farm during the collection period.
The results of the study will "increase far-reaching oversight for farm animal veterinarians," Flynn said – and clamp down on drug misuse. "We need to know what drugs are being used on the farm and for what purpose."
Some data are already available. The National Antimicrobial Resistance Monitoring Systems, (NARMS) is a strategic program monitoring antimicrobial resistance patterns in bacteria isolated from humans, animals at slaughter and retail meat.
Under the FDA‘s Animal Drug User Fee Act, drug companies are required to report basic information about antibiotic sales.
One limitation is the lack of funding to conduct the data collection, according to the USDA’s Dr. Jack MacDonald, chief of the productivity branch under the agency’s Economic Research Service.
Congress has not allocated funding for the project in the 2016 budget, and all the agencies have been financing their efforts through the existing federal budget.
Congress passed a short-term 2016 funding bill to run the government in the late hours of Sept. 30 to avert a government shutdown.
It will take up the 2016 budget on Dec. 11. If funding doesn’t come, MacDonald said the agencies may consider a "limited" study.
The task force needs $10 million to launch the data collection.
Dr. Kathie Bjork of USDA’s Animal and Plant Health Inspection Service said once funding is approved, the task force could being on-farm studies within four months.
She stressed the government will protect individual farm drug sales figures as confidential information.
Dr. Kathy Simmons, the chief veterinarian for the National Cattlemen’s Beef Assoc., cautioned officials that before the study begins, there needs to be a clear strategy for the process.
"We do not believe that the reduction in the volume of antimicrobial drugs used in food-producing animals should be used as the sole measurement for the success of a judicious antimicrobial drug use strategy," she said.
Instead, "there must be a way to link antimicrobial drug use metrics with the reason for drug use and animal population parameters, rather than simply reporting aggregate (drug) quantities for which the only goal is reduction."
The latest federal data in August show animal drug sales of medically important antimicrobials increased by 3 percent in 2013, and by 20 percent between 2009 and 2013.
The 2013 sales accounted for 62 percent of all antimicrobials approved for use in food animals. The study showed tetracycline accounted for 71 percent and penicillin, 9 percent.
If the planned date collection begins by January, it will not be completed until the end of 2018. A final report will be released by 2020.
The FDA will collect public comments until Nov. 30, on suggested ways of collecting additional drug use data.
To comment online, go to www.regulations.gov or to provide written comments, write to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
