FDA employees balk at ban on agricultural pursuits
Just after part-time farmer Lonnie Luther chopped corn silage on his Damascus farm this fall, he got a letter from his employer the U.S. Food and Drug Administration that told him that this year's harvest could be his last.
The Sept. 29 memo said the lifelong farmer who bought his first farm in Montgomery County a few years after he went to work for the FDA in 1974 had 60 days to sell his farming interests because selling food has been deemed to violate conflict of interest laws governing FDA employees.
Because farms sell food and the FDA regulates it, the agency has decided employees whose positions require them to file financial disclosures are not allowed to work for the agency and "have a financial interest in a farming operation."
"There's no way I can parlay my work into a conflict of interest," said Luther, a special assistant to director of the FDA's Office of New Animal Drug Evaluation, who with his wife, Mina, raises beef cattle, corn, soybeans, hay and "fancy" show chickens for breeding.
FDA officials recently decided to reconsider a ban in the wake of shock and outrage from Luther and other farmers who work at the FDA, many of whom have reported their farming to the agency through financial disclosures for years.
Enforcement of the ruling will be held in abeyance, FDA officials said late last month.
Luther's reprieve came in an Oct. 26 e-mail that Bernadette Dunham, director of the FDA'S Center for Veterinary Medicine, in which Luther works, sent to center employees. An FDA-wide e-mail recently followed and the FDA is looking at amending the regulations to allow greater flexibility for employees who own or work on family farms, Raymond Formanek, an FDA spokesman said.
The ruling means "I don't have to sell my farm this month, but they did not do this voluntarily," Luther said last week.
The FDA regulates contaminants, including levels of hormones and antibiotics, which can affect food for people and animals, as well as drugs for humans, livestock and pets. The U.S. Department of Agriculture regulates meat and poultry.
Luther, who planned to retire in January anyway, said he took up the fight for the next generation and for FDA employees who feared retribution if they spoke out.
"What we have are bunch of stupid people who don't have a clue about agriculture trying to regulate agriculture," said Luther, referring to lawyers and other officials who reinterpreted FDA ethics regulations and pronounced a ban. "This is not the fox guarding the henhouse; this fox doesn't even know what a henhouse is."
Agency officials said they do not know how many FDA employees could be affected by a ban on farming.
In the Center for Veterinary Medicine, as many as three dozen employees could be affected by the no-farming rule, Luther said. And many of those employees aren't retiring from the agency and therefore "can't walk away from" an issue that remains unsettled.
Katherine Weld who could be affected by the ruling because she grows hay and raises meat goats in Frederick County, while supervising the review of generic animal drugs for approval at the FDA said the FDA's judgment on the issue seemed "discriminatory and illogical."
The no-farming interpretation is based on a prohibition against most FDA employees having financial interests in a "significantly regulated organization," which is defined as an entity for which 10 percent or more of annual sales revenue comes from products that the FDA regulates.
FDA regulations make exceptions to allow physicians, veterinarians, dentists, pharmacists and nurses to work for "significantly regulated organizations," Weld noted in a letter to Department of Health and Human Services Secretary Kathleen Sebelius. The FDA is part of the Department of Health and Human Services.
The regulations appear to have been in the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services for more than a decade.
"Even though these regulations have been in place for many years, there have been evolving legal interpretations on what constitutes an FDA-regulated product' as applied to farm crops and food animals," the FDA's ethics and integrity director, Vincent Tolino, wrote in an emailed response to The Gazette's questions, which was forwarded by the agency's public information office.
"There was really no exact point when an interpretation changed," Tolino wrote in another email. "Over time, many employees have raised questions about selling food and the Ethics and Integrity staff went to the FDA Office of the Chief Counsel for advice."
Weld, who holds a doctorate in animal science, said the work that she and many others do at the FDA while farming part-time "wouldn't give anyone a leg up."
Luther, who holds a doctorate in poultry science, said he has drawn support from the Maryland and Montgomery County Farm Bureaus, which sent letters to Sebelius.
"The commodity markets are extremely competitive, and it is impossible for an FDA employee to profit unethically from the sale of farm products plant or animal," Montgomery Farm Bureau President George Lechlider wrote to Sebelius in an Oct. 15 letter.
Unlike selling stocks or bonds, it would be "nearly impossible" to sell a farm in 60 days, and doing so usually would result in the farmer selling his or her home, Lechlider wrote.
Weld and Luther said they still are worried because they haven't been shown the changes to the regulations the FDA is considering.
"The proposed amendment is in the conceptual stage and a final draft has not yet been developed," Formanek wrote in an e-mail response to The Gazette's request for the text.
The process is "detailed" and "there is no formal timeline," he said. The amendment is subject to approval of the Secretary of Health and Human Services and the Director of the Office of Government Ethics.
The "strongest advice" restricting FDA employees' investment in farming was issued in the "last few months" and "there have been ongoing questions and answers between FDA ethics , our legal counsel and center officials for the last 10 [to] 12 months," Tolino wrote in an e-mail.
Some FDA employees might already have taken losses because they sold or leased their land quickly, including some outside the Washington, D.C. region, Weld and Luther said. Their other options included removing themselves as an owner and officer of the farm operation and turning those jobs over to a spouse, or requesting an exception from a review board.
Luther said the fundamental assumptions that FDA ethics officials are making should be examined.
"It's just a mystery to me why they issued those rulings in the first place," he said.