NRDC Seeks FDA Documents Assessing Risks of Antibiotics in Livestock Production
The Natural Resources Defense Council (NRDC) has filed a lawsuit against the
Food and Drug Administration (FDA) and the Center for Veterinary Medicine
(CVM) alleging that they have failed, in response to a Freedom of Information
Act (FOIA) request, to produce documents pertaining to risk assessments for
antibiotics used in livestock production. NRDC v. FDA, No. 12-4757 (S.D.N.Y., filed June 18, 2012).
Seeking a declaration that the defendants violated FOIA and an order that
they disclose “all responsive, non-exempt records to plaintiff within fifteen
days,” NRDC refers to industry guidance that FDA issued in 2003 on “assessing
the safety of antimicrobial new animal drugs with regard to the microbiological
effects on bacteria of human health concern” and actions the defendants
have taken since then relying on the guidance.
After FDA acknowledged in a December 2011 Federal Register notice that it had begun “to look at the safety of some . . . already approved drugs” due to the “antimicrobial resistance risks associated with their use,” NRDC filed a FOIA request for “the results of any qualitative microbial food safety risk assessments of specific animal drug products that CVM has conducted since 2003” and all communications relating to these risk assessments. NRDC contends that FDA and CVM were required to respond to the request by June 8, 2012.
