In Re Natural Resources Defense Council
645 F.3d 400
D.C. Cir.2011Background
- NRDC filed a citizen petition with FDA on Oct 21, 2008 seeking prohibition of BPA in human food and revocation of regulations permitting BPA as a food additive.
- NRDC sought a registry of final FDA action through mandamus, arguing the FDA had delayed beyond statutory timelines.
- FDA argued exclusive jurisdiction over final agency action on such petitions lies in the courts of appeals under 21 U.S.C. § 348(g)(1) or, alternatively, in district court under APA review for delays.
- NRDC asserted that Section 409 governs citizen petitions and that regulations under 10.30 direct petition handling, so jurisdiction should be in this court.
- FDA maintained the citizen-petition process is non-statutory and review of final action on such petitions should be in district court; TRAC exception does not apply due to possible delays and tentative responses.
- NRDC petition was filed in this court; FDA provided a tentative response on May 6, 2009 and never issued a final decision at issue.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether exclusive jurisdiction lies in this court for NRDC's citizen petition. | NRDC relies on §409 governing citizen petitions. | FDA contends final action may lie in district court; TRAC exception not applicable. | Jurisdiction is not exclusive to this court; petition dismissed for lack of jurisdiction. |
| Whether the FDA's tentative response triggers jurisdictional consequence. | Tentative response may still lead to final action reviewable in this court. | Tentative response does not constitute final agency action. | TRAC-like jurisdiction not triggered; final action not shown to lie exclusively here. |
| Whether NRDC could have pursued a food additive petition to obtain exclusive review in this court. | New data should be submitted as a food additive petition for exclusive review under §409. | NRDC could have chosen food additive petition; it chose citizen petition. | Exclusive jurisdiction via §409 not triggered; bifurcated path governs where applicable. |
| Whether the NRDC petition could be reviewed under the APA in district court. | APA review available for unreasonable delay. | District court review only if final action lies there and not under §409. | APA delay claims not sufficient to vest jurisdiction in this court. |
Key Cases Cited
- Cutler v. Hayes, 818 F.2d 879 (D.C.Cir. 1987) (exclusive review schemes; agency actions subjected to discrete review provisions)
- TRAC v. FCC, 750 F.2d 70 (D.C.Cir. 1984) (narrow exception for agency action reviewal when final action lies in courts of appeals)
- Moms Against Mercury v. FDA, 483 F.3d 824 (D.C.Cir. 2007) (TRAC exception limited; speculative final-review path inadequate for jurisdiction)
- Mashpee Wampanoag Tribal Council v. Norton, 336 F.3d 1094 (D.C.Cir. 2003) (APA delay actions; district court review where final action not clearly in appeals court)