Natural Resources Defense Council, Inc. v. United States Food & Drug Administration
710 F.3d 71
2d Cir.2013Background
- NRDC sues FDA under the APA to compel finalization of regulation for triclosan and triclocarban in OTC topical antiseptic drugs.
- FDA has not finalized the topical antiseptic monograph under the OTC Drug Review, though enforcement allows market presence absent a health-hazard finding.
- NRDC seeks standing to challenge FDA delay; NRDC submits member declarations and risk documents to show potential hazards.
- Owens, a NRDC member and veterinary technician, is frequently exposed to triclosan-containing soap at work.
- NRDC relies on Janssen, Markey Letter, and FDA Consumer Notice to show triclosan/triclocarban risks and the need for final regulation.
- District court granted summary judgment for FDA and dismissed for lack of standing; NRDC appeals.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does NRDC have standing based on exposure to triclosan? | NRDC shows Owens’ workplace exposure to triclosan constitutes injury in fact. | Uncertain harm and lack of quantified risk undermine injury in fact and traceability. | NRDC has standing for triclosan; exposure suffices to show injury in fact and traceability. |
| Does NRDC have standing based on triclocarban? | Proliferation of triclocarban may contribute to antibiotic resistance injuring members. | No direct exposure and remote, generalized risk fail injury in fact. | NRDC lacks standing for triclocarban. |
| Is the injury attributable to FDA's delay in finalizing the monograph, i.e., is causation satisfied? | FDA delay contributes to exposure by leaving triclosan on the market. | Any exposure could be self-inflicted by choosing triclosan-containing products. | Exposure is traceable to FDA’s inaction; not self-inflicted. |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing requires injury, causation, redressability)
- Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003) (exposure to potentially harmful products may satisfy injury in fact)
- NYPIRG v. Whitman, 321 F.3d 316 (2d Cir. 2003) (environmental exposure creates injury in fact despite uncertainty)
- St. Pierre v. Dyer, 208 F.3d 394 (2d Cir. 2000) (standing and self-inflicted injury considerations in context)
- Summers v. Earth Island Institute, 555 U.S. 488 (2009) (organizational standing requires a member with standing)
- Diapulse Corp. of Am. v. United States, 457 F.2d 25 (2d Cir. 1972) (statutory/public health interests underpin standing analysis)