NY judge demands FDA action on antibiotics in animal feed

Apr 6, 2012

In what might be a show for the public, a federal judge has ordered USDA to make good on its word.

March 22, Southern District of New York U.S. Magistrate Judge Theodore H. Katz ruled the U.S. Food and Drug Administration (FDA) must act on its decades-old intent to withdraw approval of several antibiotics in feed.

The objects of contention are penicillin and tetracycline included in animal feed to “stimulate growth and improve feed efficiency in food-producing animals,” according to the court order. The court claims “medically important” antibiotics in animal feed have led to a rise in antibiotic resistant bacteria. The order backs up this claim with FDA’s own words and research.

The ruling orders FDA to act on its 1977 stated intent to withdraw approval of feeds containing the target antibiotics based on its own evidence. The issue is subtle, however, as Dr. Mike Apley, DVM, Ph.D, of Kansas State University, explains.

“The court is clear that they are not saying that the drugs should be withdrawn from use, but that the withdrawal proceedings should proceed because the FDA/CVM has not changed their findings of a lack of evidence to show that growth promotion use of the penicillins and tetracyclines are safe.”

This ruling is the result of a suit filed against FDA by a number of groups. All told, the plaintiffs of the case are Natural Resources Defense Council, Inc., Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists, Inc. The groups filed suit against FDA following its inaction to the groups’ 2011 petitions.

Of particular interest is that at least one of the plaintiffs (CSPI) regularly comes under fire from watchdog groups. The Center for Consumer Freedom—a non-profit watchdog group following selfproclaimed food safety advocates—and their spin-off group HumaneWatch—which follows the antics of anti-animal ag groups—regularly deride CSPI as “the food police.”

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Antibiotics (from page 1)

Force the FDA’s hand, but that’s not really the main point,” said Apley of the plaintiffs’ suit. “If you look on the cattle side, we don’t really use penicillin and I’d like to know where we use tetracyclines for growth promotion.” Apley went on to mention the latter is used in cattle for a disease preventative. The court action is instead focused on growth promotion and feed efficiency uses.

The use of antibiotics in feed for growth promotion and feed efficiency is a much bigger issue for the pork and poultry industries, however, according to Dr. Jim McKean, DVM, and professor at Iowa State University.

“The court action does continue to put pressure on FDA to address the growth promotion antimicrobial questions. The message for [pork and poultry] producers is they need to think about the day they won’t have growth promotion low-level uses anymore.”

Despite the fuss the plaintiffs are making, Apley didn’t see the court actions as worrisome, calling it a “side skirmish” for beef.

“In cattle, the impact [of the court action] will be minimal. What they’re trying to do is force the FDA to do what it’s already doing with Guidance 209.”

FDA Draft Guidance 209—“The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals”— is a statement of the FDA’s current thoughts on the matter. Apley pointed out the current draft, which was released in mid-2010 to public comment, is due for revision soon. “Any day we’re expecting the newest version which will show us how the FDA intends to proceeds with this.”

McKean agreed that even if something came of the court action, the impact on cattle would be minimal due to the beef industry’s lack of emphasis of antibiotics as growth promoters.

More concerning to Apley, who specializes in clinical pharmacology, is what could be around the corner on the issue of antibiotics and production animals.

“The real issue on the horizon is our prevention and control use. Unfortunately, the precedent is being set on growth promotion use which is very low consequence, but… [i]f there’s a legal precedent that comes out of this, that could be important. That’s why I watch this issue with great interest.

“It’s really interesting because this issue has become tangled in politics, anti-animal agriculture agendas, and the legitimate concern over breeding antibiotic-resistant bacteria,” he said.

In the 1950s, FDA approved the inclusion of antibiotics in animal feed to improve feed efficiency and stimulate growth in meat animals. Roughly a decade later, however, FDA became concerned how this might impact public health and safety.

In 1970, FDA created a task force to study the risks of subtherapeutic levels of medically important antibiotics in animal feed.

By 1972, the results of the study concluded the low levels of antibiotics used in animal feed promoted the growth of drug-resistant bacteria. The report said such resistance represents “a mounting public health problem of global significance.”

By 1973, FDA began considering withdrawing its approval of animal feeds containing penicillin and two forms of tetracycline. Data and appeals from drug producers were sought and collected until 1975.

The data was reviewed by the Bureau of Veterinary Medicine and in 1977, they issued a report suggesting approval be withdrawn from feeds containing those drugs.

FDA then issued notices of an opportunity for hearing. Twenty drug companies, agricultural organizations and individuals applied for hearings. The hearings never happened, however, and disappeared into bureaucratic request for postponements and calls for continued study.

In May 2011, the plaintiffs of the current suit issued two Citizen Petitions to FDA to act on its earlier considerations. FDA did not respond directly, but withdrew its original notices in December 2011, calling them outdated and the petitions moot. — Kerry Halladay, WLJ Editor