Styrene Information and Research Center, Inc. v. Sebelius

851 F. Supp. 2d 57, 2012 U.S. Dist. LEXIS 44214, 2012 WL 1059734
CourtDistrict Court, District of Columbia
DecidedMarch 30, 2012
DocketCivil Action No. 2011-1079
StatusPublished
Cited by15 cases

This text of 851 F. Supp. 2d 57 (Styrene Information and Research Center, Inc. v. Sebelius) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Styrene Information and Research Center, Inc. v. Sebelius, 851 F. Supp. 2d 57, 2012 U.S. Dist. LEXIS 44214, 2012 WL 1059734 (D.D.C. 2012).

Opinion

MEMORANDUM OPINION

REGGIE B. WALTON, District Judge.

The plaintiffs, Styrene Information and Research Center, Inc. and Dart Container *60 Corporation, seek declaratory and injunctive relief requiring the United States Department of Health and Human Services (“HHS”) to withdraw the Twelfth Annual Report on Carcinogens (“Report on Carcinogens”) with respect to the chemical styrene. Complaint (“Compl.”) ¶ 1. The plaintiffs assert claims under the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 701-706 (2006); the Public Health Service Act (“PHSA”), 42 U.S.C. § 241 (2006); the Information Quality Act (“IQA”), 44 U.S.C. § 3516 (2006); and the Due Process Clause of the Fifth Amendment of the United States Constitution. Compl. ¶¶ 70-77. Currently before the Court is the plaintiffs’ Motion to Complete the Administrative Record and to Compel Discovery. Upon careful consideration of the plaintiffs’ motion, all related memoranda of law, and the administrative record (“A.R.”), 1 the Court grants in part and denies in part the plaintiffs’ motion.

I. BACKGROUND

The following facts are either undisputed or part of the administrative record. The Public Health Service Act requires the Secretary of HHS to publish a list of all substances known or reasonably anticipated to be carcinogens. 42 U.S.C. § 241(b)(4). Pursuant to this statutory directive, HHS’s National Toxicology Program (the “NTP”) prepares a biennial Report on Carcinogens. See 72 Fed.Reg. 18999 (Apr. 16, 2007). A substance under consideration for listing undergoes a multistep review process. Compl. ¶ 25. First, the NTP publishes notice in the Federal Register, and prepares a draft background document reviewing the scientific literature and the public comments. Id. Next, a panel of scientific experts (“the Expert Panel”) conducts a peer review of the background document and issues a report containing comments and a listing recommendation. Id. Based on the Expert Panel report and the public comments, the NTP prepares a draft Report on Carcinogens, and submits it to the Secretary of HHS for approval. Id.

On May 19, 2004, the NTP set this process in motion when it nominated the chemical styrene for listing in the Twelfth Report on Carcinogens. Compl. ¶ 29; 69 Fed.Reg. 28940 (May 19, 2004). Derived from petroleum and natural gas byproducts, styrene is used to manufacture a variety of consumer goods, including food containers. Compl. ¶ 11. After preparing a draft background document on styrene, based on publicly available scientific literature, the NTP convened an Expert Panel to peer-review the document on July 21 and 22, 2008. Id. ¶¶ 26, 37. The Expert Panel was divided into subgroups based on areas of expertise, with each subgroup drafting a section of the Expert Panel report. Defs.’ Opp’n at 10; see, e.g., Pis.’ Mem., Exhibit (“Ex.”) 2 (Styrene Expert Panel Report A) at 11 (including comments from “Subgroup 2”). The full panel then reviewed the subgroups’ reports and decided whether they should be rejected or incorporated into the final Expert Panel report, with or without modification. Defs.’ Opp’n at 10.

Ultimately, the Expert Panel voted 8-2 to recommend that “styrene ... be listed in the [Report on Carcinogens] as reasonably anticipated to be a human carcinogen *61 based on limited evidence of carcinogenicity in humans and sufficient evidence in animals.” Answer ¶38. Based on this recommendation, the NTP finalized the background document and proceeded to produce a draft substance profile on styrene for inclusion in the Twelfth Report on Carcinogens. Compl. ¶¶ 50-51. On June 10, 2011, HHS Secretary Kathleen Sebelius signed the final Twelfth Report on Carcinogens, which listed styrene. Id. ¶¶ 1, 69.

Later that same day, the plaintiffs instituted this action for declaratory and injunctive relief, seeking the withdrawal of the Twelfth Report on Carcinogens with respect to styrene. Id. at 1. The plaintiffs allege that HHS acted arbitrarily and capriciously in its procedures and substantive listing decision. Id. ¶ 1. The plaintiffs further allege, among other things, that the Expert Panel performed independent, non-peer-reviewed analysis rather than a peer review of publicly available scientific literature, id. ¶¶ 38-49; that the Expert Panel was biased, id. ¶ 39; that the NTP failed to weigh all relevant evidence, id. ¶¶ 56-59; and that the NTP’s conclusion that styrene is “reasonably anticipated” to be a human carcinogen is inconsistent with the findings of the Agency for Toxic Substances and Disease Registry (“ATSDR”), an operating division of HHS, which findings were based on the same scientific evidence as the NTP’s listing decision, id. ¶¶ 21, 24.

On August 9, 2011, the plaintiffs served on the defendants a request for production of documents which, in the plaintiffs’ view, should have been included in the administrative record. Pis.’ Mem., Ex. 4 (Plaintiffs’ August 9, 2011 Letter Regarding the First Request for Production of Documents). In their letter in reply, the defendants refused to comply with the document request, noting that “discovery is generally inappropriate in record review cases.” Id., Ex. 5 (Defendants’ September 8, 2011 Letter in Reply to First Request for Production of Documents). Apparently seeking to fulfill their obligation to meet and confer as required by Local Civil Rule 7(m), the plaintiffs responded by e-mail on September 22, 2011, seeking to discuss the possibility of “limited discovery,” despite the “definitive language in [the defendants’] letter.” Pis.’ Reply, Ex. A (Plaintiffs’ September 22, 2011 E-mail) at 1. Four days later, and before receiving a reply to their September 22, 2011 e-mail, the plaintiffs filed the present Motion to Complete the Administrative Record and to Compel Discovery.

The plaintiffs’ motion asserts that the defendants improperly excluded from the administrative record certain materials that were before the agency when it decided to list styrene in the Twelfth Report on Carcinogens. Pis.’ Reply at 1. Specifically, the plaintiffs seek to “complete” the record with “(1) documents relating to the work performed by the various subgroups of the Expert Panel, (2) independent analyses conducted by the [NTP] or others of data from the studies reported in the [s]tyrene [background [d]ocument, [and] (3) documents relating to the [ATSDR’s] Cancer Policy Chart and the Portier Letter.” Id. at 1-2. 2 The plaintiffs contend that the subgroup reports, the independent analyses, and the ATSDR Cancer Policy Chart were considered by the agency in its listing decision, and hence were improperly excluded from the administrative record. See id. 6-10.

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851 F. Supp. 2d 57, 2012 U.S. Dist. LEXIS 44214, 2012 WL 1059734, Counsel Stack Legal Research, https://law.counselstack.com/opinion/styrene-information-and-research-center-inc-v-sebelius-dcd-2012.