*fn5,The opinion of the court was delivered by: Reggie B. Walton United States District Judge,STYRENE INFORMATION AND RESEARCH CENTER, INC., AND DART CONTAINER CORPORATION PLAINTIFFS, v. KATHLEEN SEBELIUS, SECRETARY OF UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, AND UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEFENDANTS." />

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Styrene Information and Research Center, Inc., and v. Kathleen Sebelius

March 30, 2012 *fn5

STYRENE INFORMATION AND RESEARCH CENTER, INC., AND DART CONTAINER CORPORATION PLAINTIFFS,
v.
KATHLEEN SEBELIUS, SECRETARY OF UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, AND UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEFENDANTS.



The opinion of the court was delivered by: Reggie B. Walton United States District Judge

MEMORANDUM OPINION

The plaintiffs, Styrene Information and Research Center, Inc. and Dart Container 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."),*fn1 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 multi-step 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., Pls.' 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 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. Pls.' 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." Pls.' 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. Pls.' 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 [b]ackground [d]ocument, [and] (3) documents relating to the [ATSDR's] Cancer Policy Chart and the Portier Letter." Id. at 1-2.*fn2 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. The plaintiffs further argue that background documents relating to a letter by the director of the ATSDR, Dr. Christopher Portier ("the Portier Letter"), are unprivileged and discoverable because they were prepared as "collusive document[s] . . . as a defensive response to a letter from [p]laintiffs' counsel." Id. at 10-11.

The defendants oppose adding any of the requested documents to the record on several grounds. First, they argue that the motion should be summarily dismissed because the plaintiffs failed to confer with the defendants, "either in person or by telephone," to discuss resolving discovery disputes, as required by Local Civil Rule 7(m).*fn3 Defs.' Opp'n at 1. Second, the defendants argue that supplementing the administrative record is inappropriate because the plaintiffs failed to allege bad faith or an improper agency motive that would justify including extra-record evidence. Id. at 5-6. Third, the defendants contend that some of the requested materials are already included in the administrative record. Id. at 13. Finally, the defendants argue that certain requested materials were properly excluded from the administrative record because they were not actually considered by the NTP, id. at 13, or because they are privileged deliberative documents, id. at 15-16.

II. STANDARD OF REVIEW

Section 706 of the APA governs judicial review of the Report on Carcinogens as mandated by the Public Health Service Act, 42 U.S.C. § 241 (2006). See Tozzi v. U.S. Dept. of Health & Human Services, 271 F.3d 301, 310-11 (D.C. Cir. 2001). Ordinarily, judicial review under the APA is confined to "the full administrative record that was before the Secretary at the time he made his decision." Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420 (1971), abrogated on other grounds by Califano v. Sanders, 430 U.S. 99 (1977). The agency must compile for the court an administrative record that includes "all information it considered either directly or indirectly." Marcum v. Salazar, 751 F. Supp. 2d 74, 78 (D.D.C. 2010); accord Bar MK Ranches v. Yuetter, 994 F.2d 735, 739 (10th Cir. 1993).

"[A]bsent clear evidence to the contrary, an agency is entitled to a presumption that it properly designated the administrative record." Calloway v. Harvey, 590 F. Supp. 2d 29, 37 (D.D.C. 2008). However, in exceptional cases, this presumption of regularity may be rebutted and a court may either (1) supplement an incomplete record with materials that were before the agency and were considered directly or indirectly by the agency decisionmaker, or (2) permit the introduction of "extra-record evidence." Marcum, 751 F. Supp. 2d at 78.

Supplementation of the record is appropriate in three circumstances: "(1) if the agency deliberately or negligently excluded documents that may have been adverse to its decision, (2) if background information was needed to determine whether the agency considered all the relevant factors, or (3) if the agency failed to explain administrative action so as to frustrate judicial review." City of Dania Beach v. F.A.A., 628 F.3d 581, 590 (D.C. Cir. 2010) (citing American Wildlands v. Kempthorne, 530 F.3d 991, 1002 (D.C. Cir. 2008)) (internal quotation marks omitted). To rebut the presumption of regularity, the party seeking supplementation must "put forth concrete evidence that the documents it seeks to 'add' to the record were actually before the decisionmakers." Marcum, 751 F. Supp. 2d at 78. Conclusory statements will not suffice; rather, the plaintiff "must identify reasonable, non-speculative grounds for its belief that the documents were considered by the agency and not included in the record." Id. (quoting Pac. Shores Subdivision Cal. Water Dist. v. U.S. Army Corps of Eng'rs, 448 F. Supp. 2d 1, 6 (D.D.C. 2006)) (internal quotation marks and emphasis omitted). "If an agency did not include materials that were part of its record, ...


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