944 F. Supp. 2d 71
D.D.C.2013Background
- Styrene Center and Dart sue HHS under the APA challenging the listing of styrene in the Twelfth Report on Carcinogens.
- NTP follows a four-step review process to determine listing, including nomination, peer review, panel reviews, and finalization by the Secretary.
- Listing criteria distinguish between known human carcinogen and reasonably anticipated human carcinogen; styrene was listed as reasonably anticipated based on human and animal data and mechanisms.
- Expert Panels and other scientific groups recommended listing as reasonably anticipated; Secretary approved and published the listing in June 2011.
- Plaintiffs allege procedural defects, misapplication of criteria, and IQA violations; Intervenors join in defense.
- The court granted defendants’ cross-motions for summary judgment and denied the plaintiffs’ motion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Timeliness of challenge to listing criteria | Styrene challenge timely because criteria applied to styrene only recently. | Challenge time-barred; criteria promulgated in 1996. | Timeliness preserved; challenge to criteria deemed timely due to application to styrene. |
| Exhaustion/waiver of challenge to Listing Criteria | Plaintiffs raised concerns about criteria in administrative filings. | Plaintiffs failed to raise the issue during notice and comment periods. | Waived; not raised during agency proceedings. |
| Whether Expert Panel’s data handling and background document process violated procedures | Panel re-analyzed data beyond reporting; violated NTP guidelines. | No judicially manageable standard; review barred by 5 U.S.C. § 701(a)(2). | Review of this challenge barred; no adequate legal standard to assess. |
| Whether listing styrene was arbitrary and capricious | Birnbaum memoranda and process undermine the decision. | Contemporaneous explanation in the substance profile governs; agency reasonably rational. | Decision upheld; rational connection to data and listing criteria; Birnbaum memoranda not determinative. |
Key Cases Cited
- Harris v. FAA, 353 F.3d 1006 (D.C. Cir. 2004) (AP A six-year limitations period applies to final agency action actions)
- P&V Enterps. v. U.S. Army Corps of Eng’rs, 516 F.3d 1021 (D.C. Cir. 2008) (jurisdictional accrual and review despite time limits when challenged action affects rights)
- NLRB Union v. FLRA, 834 F.2d 191 (D.C. Cir. 1987) (agency rule challenges require standing and can be waived if not raised earlier)
- Overton Park, 401 U.S. 402 (U.S. 1971) (avoid inquiry into mental processes absent bad faith; rely on contemporaneous explanations)
- Camp v. Pitts, 411 U.S. 138 (U.S. 1973) (contemporaneous explanation governs review; avoid judicial introspection of agency motives)
- State Farm Mut. Auto. Ins. Co. v. Mfrs. Ass’n, 463 U.S. 29 (U.S. 1983) (requires rational connection between data found and final decision)
- IMS, P.C. v. Alvarez, 129 F.3d 618 (D.C. Cir. 1997) (reasonable agency interpretation of scientific data in technical matters)
- National Small Shipments Traffic Conference v. ICC, 725 F.2d 1442 (D.C. Cir. 1984) (procedural challenges require showing bad faith or improper behavior for review)
- In re Subpoena Duces Tecum, 156 F.3d 1279 (D.C. Cir. 1998) (avoid inquiry into internal thought processes absent bad faith)
- Nuclear Energy Inst., Inc. v. EPA, 373 F.3d 1251 (D.C. Cir. 2004) (court defers to agency scientific judgments under deferential review)