FDA Sued to Force Release of Livestock Drug Records

The Food and Drug Administration faces a new lawsuit challenging its assurances that it is finally taking seriously the overuse and misuse of antimicrobial drugs in livestock feed giving rise to drug-resistant "super diseases." An estimated 70,000 Americans die each year from drug-resistant infections, ranging from salmonella to staph, spurred by 30 million pounds of these drugs pumped into feed troughs primarily to promote livestock growth.

The suit filed today by Public Employees for Environmental Responsibility (PEER) under the Freedom of Information Act seeks documents identifying which livestock drugs FDA has approved for use in healthy livestock without conducting any environmental reviews. The suit also demands support for FDA claims that it is working successfully with industry "to phase out production uses of medically important antimicrobials," according to a December 2011 notice that the agency would not pursue regulatory action.

The lion's share of antimicrobial use (80%) comes from this non- or sub-therapeutic dosing of livestock. The only effective strategy for stemming spreading antimicrobial immunity is to keep these drugs out of the waste stream altogether, something that industry, both livestock and drug makers, has fiercely resisted. Since November 4, 2011, PEER has asked FDA to surrender documents detailing the agency's reliance on "categorical exclusions" to avoid having to conduct environmental assessments required under the National Environmental Policy Act in approving animal pharmaceuticals for sub-therapeutic uses. Categorical exclusions are the bureaucratic devices that infamously allowed the BP Deepwater Horizon operations in the Gulf of Mexico to escape official review before the disastrous 2010 spill. FDA's reliance on the same device means that it automatically green-lights massive amounts of livestock drugging without any consideration of consequences. FDA has yet to provide any of these documents.

"FDA also does not even consider the post-dosage effects of these livestock drugs, most of which are not metabolized by the animal and remain in the tidal wave of livestock waste flowing from factory farms," stated New England PEER Director Kyla Bennett, a biologist and attorney formerly with the U.S. Environmental Protection Agency. "These chemicals make their way into our rivers and lakes where effects on wildlife are already being seen. Not surprisingly, these drugs are now present in the drinking water of nearly 50 million Americans."

Since January 4, 2012, PEER has also been seeking records documenting the basis for FDA's decision to withdraw two notices regarding potential revocation of approval for certain uses of penicillin and tetracyclines in animal feed. FDA said action was not needed because it had secured agreement from the animal pharmaceutical industry to work voluntarily with it. To date, however, FDA has produced no such agreement or indeed any evidence that industry is voluntarily reducing livestock drug volumes.

"Nearly 40 years ago, FDA itself first raised the alarm about antibacterial resistance from mega-dosing of livestock," said PEER Counsel Kathryn Douglass who today filed the complaint in the U.S. Federal District Court for the District of Columbia. "Unfortunately since then, through Congressional intervention or the threat thereof, industry has kept FDA cowed."