Proposed antibiotic feed ban rouses allied groups

WASHINGTON - As the U.S. Food and Drug Administration (FDA) faces a regulatory petition to ban antibiotics in animal feed, veterinary leaders watch as Congress considers roughly identical measures.

Veterinary leaders deem attempts to ban antibiotics in animal feed too restrictive. Political pressure threatens animal health,they say.

At presstime, The Preservation of Anti-biotics for Medical Treatment Act of 2005 was reintroduced in the Senate with a House companion bill expected to follow. Senate Bill 742 proposes a Federal Food, Drug, and Cosmetic Act amendment that would promptly ban feed-additive use of seven classes of antibiotics in agriculture. Sponsored by Sens. Olympia Snowe and Edward Kennedy, the bill would phase out non-therapeutic use of antibiotics in feed over two years unless manufacturers adequately demonstrate that specific drug uses do not promote resistance in humans.

While stakeholders in animal agriculture do not believe proposals to ban antibiotics in feed will move far or fast, the efforts concern the American Association of Bovine Practitioners (AABP), American Association of Swine Veterinarians (AASV) and Animal Health Institute (AHI), whose leaders contend such increased regulations will encourage animal disease and suffering. The petition and legislation targetspenicillins, tetracyclines, macrolides, lincosamides, strepto-gramins, aminoglycosides and sulfonamides. To drive support for FDA's current regulatory efforts to stave off antimicrobial resistance through risk assessment, AABP and AASV want the American Veterinary Medical Association (AVMA) to enter the debate.

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AVMA officials weren't prepared, at presstime, to weigh in, says Dr. Lyle Vogel, director of AVMA's Scientific Activities Division. The association needs time to review, he says.

"We do have some concerns with the bill in that if implemented, it would restrict or eliminate some uses of antibiotics to prevent disease, which will have a negative impact on the health and welfare of animals," he says. "But I don't know that we'll get involved. We have faith in the FDA process to thoroughly examine this petition, and bills like this have been introduced before and have always been killed in committee. I don't think there's anything different about this Congress."

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Applying pressure

AASV Executive Director Dr. Tom Burkgren favors a more hands-on approach. As an AVMA Legislative Advisory Committee member, he's pushing for the nation's largest veterinary association to position itself on the issue.

"If getting AVMA to adopt a position on the bills doesn't work, we'll do individual lobbying if we have to," he says. "Certainly, AVMA needs to take the appropriate stand. Bills are being dropped in both the Senate and the House; this is serious no matter how many times it's introduced."

Newly appointed AABP Executive Director Dr. Gatz Riddell says the proposed tighter regulations are politically motivated and unnecessary based on FDA's use of Guidance #152. Enacted in October 2003, the agency document establishes safety criteria for evaluating antimicrobial drugs with regard to microbiological effects on bacteria and human health concerns.

"The main thing is that if there's a valid risk assessment done that shows there's a significant problem, FDA has the power to deal with that," he says. "Advocacy groups are really just are blatantly against antimicrobials in production animals. This political pressure is based on distorted facts."

Proposed banon antibiotics in animal feed

Urging antibiotic withdrawal

The pressure comes from the American Academy of Pediatrics, American Public Health Association, Environmental Defense, Food Animal Concerns Trust and Union of Concerned Scientists - groups responsible for the petition and the legislative push.

While the petition recognizes Guidance #152 as a means for determining new antimicrobial drug safety, critics argue FDA plays little attention to drugs already on the market. "Antibiotic resistance is a serious and growing health threat, one exacerbated by overuse of antibiotics in agriculture," report petitioners in an April 7 letter to acting FDA Commissioner Dr. Lester Crawford. "We recognize that FDA's procedures for contested withdrawals of existing drug approvals can take years, so we urge you to start that process for the uses covered by the petition as soon as possible."

S.B. 742 charges: "Legislation is still necessary because of FDA's lengthy and cumbersome procedures for taking action on unsafe agricultural drugs."

AHI reacts

The safety accusations are imprudent, AHI officials counter. The trade association for drug manufacturers opposes restrictions on certain antibiotics used to maintain the health of animals. The risks are "small" and the proposed ban will result in "unintended consequences, including increased animal death and suffering," AHI officials say in a prepared statement.

"Scientific evidence, including government monitoring and surveillance data, demonstrates the careful use of antibiotics in food animals has public health benefits that far outweigh the very small risks," the statement says. "We oppose these misguided efforts and will continue to work to ensure the proper and careful use of antibiotics to keep food animals healthy and contribute to public health through the provision of a safe supply of meat, milk and eggs."

The U.S. stakeholders should examine European countries that have already imposed antibiotic feed additive bans, Burkgren says.

"From a pork perspective, there has been increased illness, especially in nursery pigs," he says. "While non-therapeutic use of antibiotics dropped, there was a significant increase in therapeutic use. I think a blanket ban is just not prudent at this time."