WASHINGTON, Nov. 30, 2016 - As he heads out the door, President Obama will put in place two key parts of his administration’s strategy to restrict the use of antibiotics in agriculture, part of a broader strategy for fighting drug-resistant germs. But he’s also leaving behind some proposals that could easily be reworked or spiked by the incoming Trump administration.

By the end of December, all on-farm usage of medically important antibiotics must take place for the first time under the oversight of a veterinarian. And starting next year, no antibiotics important in human medicine will be labeled for use for growth promotion and feed efficiency.

The FDA is expected to publish a series of notices in December formally approving the last of the drug companies’ labeling changes, which are expected to be effective Jan. 1. Following that date, only disease treatment and prevention will be approved uses on animal antibiotic labels.

The twin actions, which stem from a strategy that the administration first unveiled in 2010, should have a “transformational impact” on the antibiotic resistance issue, said Sam Kass, Obamas former White House food policy adviser.

The administration came under sharp criticism from consumer advocates for not mandating that companies remove growth promotion from antibiotic labels. The label changes were undertaken voluntarily at FDA’s request. But the end result was the same. All companies agreed to end the sale of the drugs for growth promotion, and that effectively ends such usage, according to Michael Taylor, who stepped down earlier this year as FDA’s deputy commissioner for foods.

“It is sometimes disparaged as a voluntary process,” he said of the labeling changes. “The only thing voluntary about it was the alignment around the goal that the industry and producers both realized needed to be achieved, which was that you’ve got to move past this ancient, anti-public health technology to a place that is better, that consumers will accept.”

Taylor sees little chance that the industry will reverse these major initiatives. “There’s very little incentive to turn backwards on this issue given where the market is and consumers are. It’s a global phenomenon.”

Indeed, earlier this fall, McDonald's announced that all of the chicken it is buying now has been raised without the use of medically important antibiotics. Meanwhile, Smithfield Foods, Tyson Foods and other major U.S. and foreign livestock producers agreed to a statement that lays out a series of steps to reduce the use of antibiotics, including ending the use of antibiotics for growth promotion in countries where it continues to be permitted. The statement also calls for improving reporting on antibiotic usage and the development of new practices and products to replace the use of antibiotics. The statement came out even as the United Nations formally called on all countries to have national action plans to fight antibiotics resistance.

Harry Snelson, a spokesman for the American Association of Swine Veterinarians, said the requirement for veterinarian approval to use antibiotics will be a change for producers but there appears to be broad awareness of the coming rule. He said the use of antibiotics for growth promotion, which will effectively be banned in January, has been declining for some time. “In most cases, veterinarians and producers are resigned to that (usage) going away,” he said.  

Another major step that the FDA took under Obama was to begin reporting each year on sales of antibiotics for food animals. The reports, the first of which was required in 2010 in response to a law Congress passed in 2008, have since doubled in size to 58 pages as FDA has added new data requirements. FDA isn’t finished: In May, the agency finalized a rule that will require companies to begin providing estimates of sales broken down by animal species – cattle, hogs, chickens and turkeys. FDA says the data would “help further target efforts to ensure judicious use of medically important antimicrobials.”

The administration also is trying to ramp up on-farm monitoring of antibiotic usage to determine to what extent resistance may be occurring in agriculture, but Taylor is concerned that the department may not get the necessary money. Congress hasn’t funded the initiative, although some money could eventually be included in USDA’s fiscal 2017 budget, which likely won’t be finalized until next spring. The monitoring is needed to verify “changes in the use of these drugs to actual reductions in resistance over time. That’s the public health goal of this whole exercise,” Taylor said.

As Donald Trump’s new administration takes charge in 2017, the drug companies could focus on limiting some of the reporting requirements that Obama has implemented. “We are taking a look at regulatory changes to see if there are suggestions we can make for greater efficiency. The issue of reporting is an area that needs attention,” said Ron Phillips, vice president of legislative and public affairs for the Animal Health Institute, which represents the drugmakers. “We have long advocated for a science-based, well-thought out system of reporting all uses of antibiotics that would help users become better and more efficient. Current sales reporting meets none of these criteria.”

The new FDA leaders also could address concerns about the veterinarian oversight requirement. The National Grain and Feed Association and the American Feed Industry Association in August petitioned FDA for relief, saying most vets lack personnel and resources needed to implement and maintain the computer systems.

Another issue Obama’s FDA is leaving behind is the idea of setting limits on how long some antibiotics can be given to livestock and poultry for treatment of infections. There are currently no time limits on some uses of the drugs. The agency in September said that it would solicit industry and public input on what the limits should be. (The deadline for comments to be filed was extended this week to March 13.) The drugs the agency is looking at include tyrosine and chlortetracycline. 

AHI hasn’t filed its comments yet, but Phillips said that any new usage limits should be "driven by science and recognize that all of these products will be used only under the direction of a veterinarian."

Environmentalists and consumer advocates have also petitioned FDA to stop seven classes of antibiotics from being used for disease prevention, including macrolides, penicillins and tetracyclines. But that plea is almost certainly going nowhere in a Trump administration.


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