WASHINGTON, D.C. — Feed manufacturers, animal health firms, industry associations and other agriculture interests last week reaffirmed their opposition to a U.S. Food and Drug Administration (FDA) proposal that would require animal antibiotic sales to be reported on a species-specific basis.

The proposal, Antimicrobial Animal Drug Sales and Distribution Reporting, would require reporting of the amount of each antimicrobial active ingredient in new animal drug products sold or distributed for use in food-producing animals. The proposal would require those active ingredient levels to be estimated on a species-by-species basis.

Making the reporting requirements species-specific does not sit well with feed manufacturers and animal health product manufacturers. “We are not debating the overall goal – to monitor the use of antibiotics within agriculture,” said Richard Sellers, American Feed Industry Assoc. senior vice president of legislative and regulatory affairs.

“We are debating FDA’s legal authority to require new animal drug sponsors to report species-specific distribution estimates. The sponsors do not have that data, and the proposed requirement to ‘estimate’ it from data extrapolation of expected use is a poor use of the available information.”

That opinion was echoed in comments last week from Zoetis. “Sales/distribution data provided by a sponsor to assess use in animals and more specifically, estimating use in food animal species, has many sources of error,” wrote John Hallberg, Zoetis director of Regulatory Affairs.

He said drug sponsors sell antibiotics to multiple types of dealers, including veterinary drug distributors, dealers, veterinarians – and animal producers. This means sponsors cannot know where and when each product is used, especially since animal antibiotics are often approved for use across species.

“Few animal antibacterial products are approved for use in a single animal species and for a single indication,” said Hallberg.

According to a comment from the American Veterinary Medicine Assoc. (AVMA), requiring sales estimates by species would create potential for misinterpretation of the levels of antibiotic use.

“Use of sales data to estimate antimicrobial use has been shown to be extremely inaccurate, with the potential for serious misinterpretation,” stated the AVMA, which recommended the FDA explore other means of reporting animal antibiotic use.

Some industry concerns point to the National Animal Health Monitoring System as a better way to monitor total animal antibiotic use. Under NAHMS, FDA can partner with the USDA to collect antibiotic use data, as outlined in the President’s National Action Plan for Combating Antibiotic Resistance, announced earlier this year.

Not all comments submitted last week were against the FDA proposal. Comments from The Pew Charitable Trusts supported it and encouraged FDA to obtain even more information. “Understanding why antibiotics are being used is crucial to identifying the opportunities for reducing avoidable antibiotic use,” wrote Kathryn Talkington, director of Pew’s Antibiotic Resistance Project.

She encouraged the FDA to work with USDA and animal health experts “to develop new, more robust approaches for collecting antimicrobial usage data.” Comment last week from the Trust for America’s Health, a Maryland-based advocacy group, also supported the FDA’s species-by-species data collection proposal.

Some have also criticized the FDA proposal because it requires reporting of all antibiotics for animal use. This appears different from the aim of the White House announcement, which seemed to focus on animal agriculture use of antibiotics important in human medicine.

Large poultry producers and some important poultry buyers, like McDonald’s, announced initiatives this year that would reduce broiler farm usage of antibiotics important in human medicine.

The next step in the process to consider the FDA proposal is a public meeting to be held Sept. 30. There, the FDA, USDA and Centers for Disease Prevention and Control will “obtain public input on possible approaches for collecting additional on-farm antimicrobial drug use and resistance,” according to the meeting announcement published in the Federal Register on Aug. 20.

The September meeting will be held at the USDA Jefferson Auditorium in Washington, D.C. The public may also comment on the issue through the website www.regulations.gov