Styrene Information and Research Center, Inc. v. Sebelius
2012 U.S. Dist. LEXIS 44214
| D.D.C. | 2012Background
- The Public Health Service Act requires HHS to list known or reasonably anticipated carcinogens and the NTP prepares a biennial Report.
- Styrene was nominated for listing in the Twelfth Report in 2004 and peer-reviewed by an Expert Panel in 2008.
- The Expert Panel recommended listing styrene as reasonably anticipated to be a human carcinogen based on limited human evidence and sufficient animal evidence.
- Secretary Sebelius signed the final Twelfth Report listing styrene on June 10, 2011, prompting this APA/PHSA/IQA/Due Process suit.
- Plaintiffs seek to complete the administrative record by adding Expert Panel subgroup reports, independent analyses, and ATSDR documents; defendants oppose.
- Court grants supplementation for subgroup reports but denies other extra-record requests and independent analyses.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether subgroup Expert Panel reports should be added to the record | Subgroup drafts influenced the final Panel and NTP; not all were included. | Subgroup reports were not before the NTP and thus not in the record. | Yes; subgroup reports must be added to the administrative record. |
| Whether the NTP’s independent analyses of data must be added | Independent analyses were before the Panel and should be in the record. | Requests are speculative; no specific missing calculations identified. | Denied; no concrete grounds shown. |
| Whether Portier Letter-related documents are discoverable or in the record | Drafts and internal correspondence should illuminate the Portier Letter’s basis. | Deliberative process privilege protects predecisional materials. | Denied; Portier drafts are deliberative and predecisional. |
| Whether ATSDR Cancer Policy Chart documents should be added | Chart creates apparent contradiction and could illuminate agency factors. | Documents are extrarecord; no bad faith shown. | Denied; not necessary for review; extrarecord evidence rejected. |
Key Cases Cited
- Esch v. Yeutter, 876 F.2d 976 (D.C. Cir. 1989) (basis for eight Esch exceptions to extra-record review narrowed to four)
- Marcum v. Salazar, 751 F. Supp. 2d 74 (D.D.C. 2010) (supplementation requires concrete evidence documents were before decisionmaker)
- Commercial Drapery Contractors v. United States, 133 F.3d 1 (D.C. Cir. 1998) (limits broad discovery; bad-faith standard applied to extra-record requests)
- IMS, P.C. v. Alvarez, 129 F.3d 618 (D.C. Cir. 1997) (narrowed eight Esch exceptions to four; review cures)
- Calloway v. Harvey, 590 F. Supp. 2d 29 (D.D.C. 2008) (extra-record evidence framework and supplementation standards)
- City of Dania Beach v. FAA, 628 F.3d 581 (D.C. Cir. 2010) (standards for when supplementation is appropriate; factors to consider)