A delegation of U.S. government officials is poised to begin meetings in South Korea next week to hash out international guidelines for countering the overuse of antibiotics in farm animals.
But the draft is already causing an uproar because it appears to be weaker than current U.S. policy, which allows such drugs to prevent or treat diseases in livestock but not for growth promotion.
On Friday, four U.S. senators and one House member, all of them Democrats, raised concerns about the draft in a letter to Agriculture Secretary Sonny Perdue and Food and Drug Administration Commissioner Scott Gottlieb, whose employees are participating in the negotiations.
“We urge you to ensure that the U.S. opposes the use of medically important antibiotics in animals for growth promotion without exception when this committee meets next week,” says the letter, which is signed by Senators Dianne Feinstein, Elizabeth Warren, Richard Blumenthal and Kirsten Gillibrand and Representative Rosa DeLauro.
The U.S. is leading the antibiotics working group at Codex Alimentarius, an international commission that seeks to protect consumers and fair trade by adopting food standards, codes of practice and other guidelines. The Codex Intergovernmental Task Force on Antimicrobial Resistance is meeting in Korea starting Dec. 10.
The draft of the group’s nonbinding recommendations includes what critics describe as a loophole to allow “medically important” antibiotics to be used on livestock for growth promotion -- a practice now banned by the Food and Drug Administration.
Both the U.S. Department of Agriculture and the FDA say that such antibiotics shouldn’t be used for growth promotion. In a Dec. 3 letter to an advocacy group, William Flynn, deputy director for science policy at the FDA’s Center for Veterinary Medicine, acknowledged that the wording of the draft had “created some confusion and uncertainty around the concept that medically important antimicrobials should not be used for growth promotion.”
Flynn wrote that his agency supports “efforts to eliminate such uses worldwide.” The FDA didn’t respond to requests to make Flynn available for an interview.
Overuse of antibiotics in animals and humans has caused the medicines to lose effectiveness, prompting calls to curb non-essential uses. The extent that antibiotic use in farm animals affects human health remains open to debate, as does how best to address the problem of overuse.
In 2017, the FDA banned the use of medically important antibiotics to promote growth. Under the new policy, such drugs require a veterinary prescription and can be used only to treat, control or prevent disease.
The draft proposal for Codex says that “responsible and prudent administration” of medically important antibiotics in livestock doesn’t include using it for growth promotion, unless a risk analysis is “undertaken” by an appropriate national regulatory authority. Critics have labeled this exception a loophole.
In addition, in the latest set of proposals, the U.S. suggested making a change that would require only that such an analysis be “guided” by a regulator, said Michael Hansen, senior scientist at Consumer Reports, a consumer advocacy group.
“Basically it’s saying, ‘Let the companies do it,’” Hansen said. “It’s just crazy.”
A similar word change was proposed by HealthforAnimals, an industry trade group whose members include companies that sell animal drugs, he said. The group couldn’t immediately be reached for comment.
Asked about the change, Sally Gifford, a spokeswoman for the USDA’s Codex office, said, “Some nations’ governments have expressed concern that they do not have the capability to conduct their own risk assessments. The word change under consideration would be a response to those concerns.”
Last year, the World Health Organization issued its own recommendations for antibiotic use in livestock, calling for an end to giving medically important antibiotics routinely to healthy animals to promote growth or prevent disease. The agency said such drugs should be administered only to sick animals or healthy ones being raised near them.
That drew a sharp response from the USDA, which said the WHO’s effort was based on shoddy science and excluded input from the U.S. and other countries.
A few months earlier, in September 2017, Perdue, the agriculture secretary, announced that he was moving his agency’s Codex office out of its food safety agency and into a newly formed trade office. That drew criticism from some advocacy groups and an unusual rebuke from the FDA.
“FDA strongly believes that moving Codex to the oversight of a trade promoting, non-science organization could undermine the credibility of U.S. Codex as a science-based enterprise,” wrote Stephen Ostroff, deputy commissioner for food and veterinary medicines.
Perdue’s selection to run the trade office, Ted McKinney, is a former executive at Elanco, a company that sells drugs for livestock.