Antibiotic statements stun ag groups - Truth About Trade and Technology

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Monday, 20 July 2009 16:33

Feedstuffs FoodLink
By Sally Schuff
July 17, 2009

www.feedstuffsfoodlink.com

The Obama Administration's surprise announcement last week that it supports ending the non-therapeutic use of seven antibiotics for growth promotion and feed efficiency in the U.S. left Washington, D.C., livestock organizations nearly speechless with surprise.

The announcement came after years of debate on the risk of antimicrobial resistance emerging from feeding livestock low-level antibiotics, and it came with no warning to livestock industry stakeholders.

Dr. Joshua Sharfstein, the Food & Drug Administration's principal deputy commissioner and a pediatrician, announced the new policy as an "FDA principle" during testimony before a rare House Rules Committee policy hearing July 13.

In the same testimony, he announced that FDA now believes the judicious use of antibiotics requires that "all medications for prevention and control should be under the supervision of a veterinarian."

He told reporters that the two announcements -- opposition to the non-therapeutic use of antibiotics for growth promotion/feed efficiency and FDA's opposition to over-the-counter sales -- were the first time the agency had made those new principles public.

Later last week, Michael Taylor, FDA's newly appointed senior adviser on food safety, was called upon to explain Sharfstein's announcement during an appearance before the House Agriculture Committee on food safety.

Under questioning from Rep. Leonard Boswell (D., Iowa), Taylor testified that Sharfstein's two announcements were cleared by the White House Office of Management & Budget. Once such testimony is cleared, it is assumed to be Administration policy. Taylor made the revelation after being challenged by Boswell on the process underlying the surprise announcement.

Boswell, who was chairman of the House agriculture subcommittee on livestock last year, emerged as a key player in the controversy. He was the sole witness testifying on the importance of antibiotic use to the livestock industry during the July 13 hearing before House Rules Committee chairwoman Louise Slaughter (D., N.Y.).

The rules committee, which was criticized for having an otherwise slate of hostile witnesses on the issue, agreed to allow the House livestock subcommittee hearing record to be inserted into its hearing record.

Boswell's hearing had produced a number of scientists who explained the complexities of the resistance issue and the importance of not jumping to potentially faulty conclusions.

'Offensive' process

Slaughter, who trained as a microbiologist and has a master's degree in public health, has sponsored a bill that would phase out the non-therapeutic use of seven antibiotics in livestock production.

Her bill -- H.R. 1549, the Preservation of Antibiotics for Medical Treatment Act -- and a companion bill in the Senate sponsored by Sen. Ted Kennedy (D., Mass.) are supported by the American Medical Assn. and other respected scientific organizations.

By July 16, under pressure from livestock organizations, the House Agriculture Committee wanted some explanations.

Boswell told Taylor at the agriculture hearing, "I think some fence-mending is going to have to take place around here, because that whole process was very offensive. You deliberately tried to blindside some of us on this committee, and we don't appreciate that. ... I was stunned."

It remains unclear what the FDA announcements mean exactly or if there is a plan to implement new rules. House Agriculture Committee chairman Collin Peterson (D., Minn.) said, "We're trying to figure out what they meant."

Despite its two announcements, FDA has not taken a formal position on the Slaughter bill, Sharfstein told reporters.

However, Sharfstein testified at the rules hearing, "There is clear evidence that the use of antimicrobials in general selects for resistant organisms under conditions of constant exposure (growth promotion/feed efficiency) to antibiotics, (so) the use of antimicrobials should be limited to those situations where human and animal health are protected."

Sharfstein told reporters it was the first time FDA had publicly stated that position, but he noted that it so far applies to only seven antimicrobials considered important for use in human medicine that are listed in the bills before Congress. FDA is not opposed to the use of ionophores at this time, he said.

Of note: Sharfstein, FDA's second-highest-ranking official, was a food safety advocate/staffer for Rep. Henry Waxman (D., Cal.), who is now chair of the House Energy & Commerce Committee. Before that appointment, Sharfstein was commissioner of public health for Baltimore, Md. He is on the opposite side of agriculture and said he and FDA Commissioner Margaret Hamburg speak with one voice on growth-promoting antibiotics.

Members of the self-described "barnyard" group -- Washington-based organizations that represent livestock interests such as the American Farm Bureau Federation, National Pork Producers Council, National Cattlemen's Beef Assn. and others -- met with FDA officials June 18 to discuss key issues, but no mention was made of any policy shift on livestock antibiotic use, they reported.

"We were completely blindsided," one animal agriculture lobbyist told Feedstuffs last week.

During the hearing on her bill, Slaughter said seven classes of FDA-certified antibiotics considered "highly" or "critically" important in human medicine are currently used in agriculture as animal feed additives.

"Among them are penicillin, tetracyclines, macrolides, lincosamides, streptogramins, animoglycosides and sulfonamides," she said. "These classes of antibiotics are among the most critically important in our arsenal of defense against potentially fatal human disease."

Slaughter testified, "Despite their importance in human medicine, these drugs are added to animal feed as growth promotants and for routine disease prevention. Approximately 70% of antibiotics and related drugs produced in the U.S. are given to cattle, pigs and chickens to promote growth and to compensate for crowded, unsanitary, stressful conditions."

Slaughter reported that "the non-therapeutic use of antibiotics in poultry skyrocketed from 2 million lb. in 1985 to 10.5 million lb. in the late 1990s."

The issue of antibiotic resistance is extremely complex. Animal Health Institute vice president Ron Phillips told Feedstuffs, "Risk assessment is the proper tool for making policy decisions about the use of antibiotics in animals. Decisions made without risk assessment are likely to result in unintended consequences, including increased animal death and disease and increased risks to public health.

"It is clear that the political removal of antibiotics as growth promoters in Europe resulted in increased animal disease and increased use of antibiotics to treat that disease. We urge FDA -- and Congress -- to adhere to this Administration's stated intent to use the best available science to make decisions on policy issues like antibiotic use," Phillips added.

American Feed Industry Assn. government affairs consultant Steve Kopperud said, "It's unfortunate that FDA decided to use the House Rules Committee hearing -- an unusual forum to begin with -- to make a political policy statement rather than educate the committee on its science-based evaluation of its approval, regulation, ongoing evaluation and judicious-use program related to the use of antibiotics on farms.

"We hope FDA will continue its dialogue with agricultural groups to find a new approach to this complex scientific and political issue without penalizing animals through compromised welfare, farmers through increased production costs and consumers through higher food prices," Kopperud concluded.

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