884 F. Supp. 2d 108
S.D.N.Y.2012Background
- NRDC and co-plaintiffs sued FDA to compel withdrawal proceedings for non-therapeutic antibiotic use in livestock under APA and FDCA.
- March 22, 2012 Order held FDA must initiate withdrawal proceedings; June 1, 2012 Order reaffirmed actions on citizen petitions and withdrawal duties.
- Case was reassigned to the undersigned after Judge Katz’s retirement; briefing and argument on timing, stay, and strike issues followed.
- 1977 NOOHs issued to withdraw penicillin and most tetracycline non-therapeutic uses; hearings were never held and NOOHs later rescinded in 2011.
- FDA continued research and regulatory approaches; FDA Draft Guidance and nonbinding findings in 2010–2011 preceded litigation.
- Court adopts a schedule for compliance, finds unreasonable delay, and denies the Government’s motion to stay; strikes part of a non-record document.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Can the court impose a schedule for withdrawal proceedings? | NRDC argues for a prompt timetable to compel action. | Government argues against court-imposed deadlines, citing agency discretion. | Yes; court may impose a timetable for compliance. |
| Was the FDA's delay in initiating withdrawal proceedings unreasonable? | NRDC contends decades-long inaction violated statutory duty. | Government argues no unreasonable delay and cites resource concerns. | Yes; thirty-plus years of inaction is unreasonable delay meriting a schedule. |
| Are certain non-record materials properly strikeable from the record? | NRDC moves to strike AHI statement as outside administrative record. | Government contends background information may aid understanding. | AHI statement struck; other cited non-record materials proper to record per agreement. |
| Should the court stay the March 22 Order pending appeal? | NRDC argues no stay or limited one would harm public health protections. | Government seeks stay to preserve agency resources and ongoing programs. | Stay denied; public interest favors enforcement of withdrawal proceedings. |
| Does the FDCA require withdrawal proceedings after a finding of not being safe, triggering reviewable action? | NRDC argues the statute creates a duty to initiate withdrawal. | Government contends findings and timing are within agency discretion and not reviewable. | Court determined the withdrawal duty is triggered by findings and not delayed without justification. |
Key Cases Cited
- Barr Laboratories, Inc. v. Norton, 930 F.2d 72 (D.C. Cir. 1991) (unreasonable delay justifies timetable; not every delay requires mandamus)
- Massachusetts v. EPA, 549 U.S. 497 (S. Ct. 2007) (informal rulemaking; reviewability of agency actions under APA)
- Norton v. Southern Utah Wilderness Alliance, 542 U.S. 55 (U.S. 2004) (statutory duty and discrete actions under APA identified)
- Winter v. NRDC, 555 U.S. 7 (U.S. 2008) (stay standard; preliminary injunction standards applicable to stays)
- Shays v. FEC, 340 F. Supp. 2d 39 (D.D.C. 2004) (standards for stay and irreparable harm; public interest factors)
- Cobell v. Norton, 240 F.3d 1081 (D.C. Cir. 2001) (broad equitable powers; court may impose timetable for compliance)
- Public Citizen Health Research Group v. Brock, 823 F.2d 626 (D.C. Cir. 1987) (unreasonable delay; court-ordered rulemaking timelines)