Court Opinion

ID: 2662625
Source: CourtListenerOpinion
Date Created: 2014-04-03 12:35:40.018622+00
Date Added: 2024-06-11T09:17:43.819400
License: Public Domain

UNITED STATES DISTRICT COURT
                           FOR THE DISTRICT OF COLUMBIA
__________________________________________
                                            )
STYRENE INFORMATION AND                     )
RESEARCH CENTER, INC., and                  )
                                            )
DART CONTAINER CORPORATION                  )
                                            )
                             Plaintiffs,    )
                                            )
       v.                                   )    Civil Action No. 11-1079 (RBW)
                                            )
KATHLEEN SEBELIUS,                          )
Secretary of United States Department of    )
Health and Human Services, and              )
                                            )
UNITED STATES DEPARTMENT OF                 )
HEALTH AND HUMAN SERVICES,                  )
                                            )
                             Defendants.    )
__________________________________________)

                                 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.”), 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 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

1
 In addition to the filings already identified, the Court considered the following submissions in rendering its
decision: (1) the Memorandum in Support of Plaintiffs’ Motion to Complete the Administrative Record and to
Compel Responses to Plaintiffs’ First Request for Production of Documents (“Pls.’ Mem.”); (2) the Defendants’
Opposition to Plaintiffs’ Motion to Complete the Administrative Record and to Compel Discovery (“Defs.’ Opp’n”);
and (3) the Plaintiffs’ Reply to Defendants’ Opposition to Plaintiffs’ Motion to Complete the Administrative Record
and to Compel Discovery (“Pls.’ Reply”).

                                                        2
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

                                                  3
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. 2 The plaintiffs

2
  The plaintiffs have withdrawn a fourth request for documents regarding the work performed by consultants on the
styrene background document. Pls.’ Reply at 2. Accordingly, the Court will address the plaintiffs’ request for the
foregoing three categories only.

                                                         4
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). 3 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

3
  Local Civil Rule 7(m) requires that counsel confer with opposing counsel, either in person or by telephone, prior to
filing any nondispositive motion. Full compliance “necessitates something more than an exchange of letters or a
chain of e-mail correspondence.” Equal Rights Ctr. v. Post Props., Inc., 246 F.R.D. 29, 31 (D.D.C. 2007). While
reliance on e-mail falls short of this requirement, the Court will not dismiss the plaintiffs’ motion on Rule 7(m)
grounds, in the interest of judicial economy. Nonetheless, the Court admonishes counsel to pay greater heed to their
duty to confer during the course of this litigation.

                                                          5
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

                                                   6
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, whether by design or accident, then supplementation is appropriate.”

Id.; see also Natural Res. Def. Council, Inc. v. Train, 519 F.2d 287, 291 (D.C. Cir. 1975)

(holding that review of a “partial and truncated record” by the district court was error and case

remanded for review on the “entire administrative record”).

         A separate standard governs extra-record evidence, which “consists of ‘evidence outside

of or in addition to the administrative record that was not necessarily considered by the agency.’”

Calloway, 590 F. Supp. 2d at 37 (quoting Pac. Shores, 448 F. Supp. 2d at 5). In Esch v. Yeutter,

876 F.2d 976, 991 (D.C. Cir. 1989), the District of Columbia Circuit stated that extra-record

evidence was reviewable if it fell within one of eight exceptions. 4 Since then, the Circuit appears

to have narrowed these exceptions to four: (1) when the agency failed to examine all relevant

factors; (2) when the agency failed to explain adequately its grounds for decision; (3) when the

agency acted in bad faith; or (4) when the agency engaged in improper behavior. See IMS, P.C.

v. Alvarez, 129 F.3d 618, 624 (D.C. Cir. 1997); see also Cape Hatteras Access Pres. Alliance v.

U.S. Dep’t. of Interior, 667 F. Supp. 2d 111, 116 (D.D.C. 2009) (noting the Circuit’s narrowing

of the Esch exceptions in its IMS decision). “Underlying all of these exceptions is the
4
 Specifically, the court stated that consideration of extra-record evidence may be warranted in the following
circumstances:

         (1) when agency action is not adequately explained in the record before the court; (2) when the
         agency failed to consider factors which are relevant to its final decision; (3) when an agency
         considered evidence which it failed to include in the record; (4) when a case is so complex that a
         court needs more evidence to enable it to understand the issues clearly; (5) in cases where
         evidence arising after the agency action shows whether the decision was correct or not; (6) in
         cases where agencies are sued for a failure to take action; (7) in cases arising under the National
         Environmental Policy Act; and (8) in cases where relief is at issue, especially at the preliminary
         injunction stage.

Esch, 876 F.2d at 991.

                                                          7
assessment that ‘resort to extra-record information [is necessary] to enable judicial review to

become effective.’” Calloway, 590 F. Supp. 2d at 38 (quoting Esch, 876 F.2d at 991).

                                              III. ANALYSIS

A.     The Expert Panel Subgroup Reports

       The plaintiffs seek to supplement the administrative record with reports prepared by the

Expert Panel subgroups during the peer review of the NTP’s draft background document. Pls.’

Reply at 6. To implement the peer review process, the Expert Panel “divided itself into

subgroups based on areas of expertise, and each subgroup drafted a section of the peer review

report.” Id. These drafts were then “considered by the full panel and incorporated into the final

version of the report, with any changes the full panel found appropriate.” Defs.’ Opp’n at 10.

However, the full Expert Panel rejected certain subgroup draft reports and omitted these from the

final report that it submitted to the NTP. See id. The plaintiffs argue that these rejected reports

were “indirectly considered by the [d]efendants in the decision to list styrene.” Pls.’ Reply at 7.

Essentially, the plaintiffs rely on a two-step theory of influence: the subgroup reports influenced

the Expert Panel’s recommendation to the NTP, and in turn, the Expert Panel’s recommendation

influenced the NTP’s decision to list styrene. Pls.’ Reply at 6-7. Thus, the plaintiffs contend

that all of the subgroup reports should have been included in the administrative record. Id. at 8.

       In response, the defendants argue that the NTP never considered the subgroup reports,

because they were not included in the Expert Panel’s final report. Defs. Opp’n at 10. Reasoning

that the subgroup reports were not before the NTP, the defendants contend that these reports

would only be permissible extra-record evidence upon a “‘strong showing of bad faith or

improper behavior’ or that the ‘record is so bare that it prevents effective judicial relief’.” Id. at

4 (quoting Commercial Drapery Contractors v. United States, 133 F.3d 1, 7 (D.C. Cir. 1998)).

                                                   8
          The Court disagrees with the defendants. It appears that the subgroup drafts were an

integral part of the Expert Panel’s peer review process and influenced the Expert Panel’s

recommendation, upon which the NTP based its listing determination. The mere fact that the

subgroup drafts were not ultimately passed on to the final decisionmaker does not lead to the

conclusion that they were not before the agency. See Amfac Resorts, L.L.C. v. U.S. Dep’t. of

the Interior, 143 F. Supp. 2d 7, 12 (D.D.C. 2001) (observing that if the agency’s final decision

was based “on the work and recommendations of subordinates, those materials should be

included as well”). Accordingly, the subgroup draft documents are not extra-record evidence,

subject to the more exacting standards applied in the cases on which the defendants rely. Cf.

Commercial Drapery, 133 F.3d at 7 (applying bad faith standard to broad discovery requests and

extra-record affidavits); Coalition on Sensible Transp. v. Dole, 826 F.2d 60, 72 (D.C. Cir. 1987)

(affirming denial of an “unlimited discovery” request for evidence that agency failed to consider

certain impacts of highway widening). Rather, the plaintiffs’ request for the subgroup reports

should be reviewed under the less stringent standard for supplementation of the administrative

record.

          Under that standard, the plaintiffs have rebutted the “presumption of regularity” by

presenting concrete evidence that the missing subgroup reports “were actually before the

decisionmakers.” Marcum, 751 F. Supp. 2d at 78. This finding is supported by the fact that the

administrative record contains several references to omitted subgroup reports. E.g., Pls.’ Mem.,

Ex. 2 (Styrene Expert Panel Report A) (referencing comments made by “Subgroup 2,”

discussing scientific literature, and making recommendations for the draft background

document). In addition, part of one subgroup report was included in the record, as an attachment

to the Expert Panel’s report. Pls.’ Mem. Ex. 6 (Attachment 1 to Section 4 Subgroup Report).

                                                   9
These references suggest that the Expert Panel substantively considered scientific information

and advice contained in the subgroup reports, and was aware of the Expert Panel’s reliance on

this information and advice. Finally, the fact that the Expert Panel adopted some subgroup

reports, but rejected others, lends some credibility to the plaintiffs’ suggestion that the rejected

reports may contain evidence adverse to the Expert Panel’s recommendation to list styrene.

       Because the subgroup reports influenced the Expert Panel report, and the Expert Panel

report influenced the NTP’s listing decision, the Court is satisfied that the NTP considered—at

least indirectly—the subgroup reports. Access to the evidence that was considered and rejected

by the Expert Panel would therefore assist the Court in conducting its arbitrary and capricious

review under the APA. And it does not appear that adding the subgroup reports to the

administrative record would be overly burdensome for the agency, as it already possesses the

reports. In short, the plaintiffs have offered non-speculative grounds for their belief that the

subgroup reports were considered by the agency, and that they contained pertinent scientific

information. The Court will therefore order that the administrative record be supplemented with

the missing subgroup reports.

B.     The NTP’s Independent Analyses of Data Reported in the Styrene Background
       Document

       The plaintiffs also assert that the defendants improperly excluded unspecified

independent analyses of data performed by the NTP or by its contractor. Pls.’ Mem. at 8.

During the peer review of the draft styrene background document, the Expert Panel received

supplemental information from a contractor. Id., Ex. 3 (Styrene Expert Panel Report A) (noting

that “[d]uring the styrene review the contractor provided trend tests for several sites, which the

Panel much appreciates.”). The Expert Panel also noted that some studies in the draft styrene

background document “did not report significance values with as great precision as is of

                                                  10
interest.” A.R. at 1123. The Expert Panel observed that for some, but not all, of these studies,

the NTP had performed its own “pairwise comparisons and trend tests” to report the statistical

significance of findings of interest. Id. The Expert Panel recommended that the NTP perform

such tests for all findings of interest. Id. In response, the NTP provided “trend tests” and

reported the results in the styrene background document, placing them “in brackets to indicate

[that they were] not contained in the original study.” Defs’ Opp’n at 11-12; see, e.g., A.R. at

1124 (“In response to a request during the peer review . . . , [the] NTP provided for the sites in

Table 4-1 the exact Cochran-Armitage trend tests.”).

       The plaintiffs contend that the administrative record is incomplete because it contains

only results, and not the NTP’s underlying statistical analyses. Pls.’ Mem. at 8. In response, the

defendants argue that reporting the results is sufficient. Defs.’ Opp’n at 11. The distinction

between the analyses and their results is immaterial, the defendants argue, because “the two tests

for statistical significance referenced by the Expert Panel . . . are straightforward calculations

that, . . . [are] never ‘shown’ in published studies.” Defs.’ Opp’n at 12. The defendants also

attack the plaintiffs’ claim of missing calculations as speculative, contending that the NTP either

performed a recommended analysis and reported its result, or explained its reasons for not doing

so. See id. at 13.

       The Court agrees that the plaintiffs’ request is speculative. In contrast to the request for

the subgroup reports, the plaintiffs’ request for the NTP’s independent analyses lacks concrete

detail and specificity. As a result, the Court finds that the plaintiffs have not rebutted the

presumption that the agency properly designated the administrative record with respect to these

documents.

                                                  11
          The plaintiffs rely solely on several references in the Expert Panel’s report to tests

performed by the NTP or its contractor. See Pls.’ Reply at 8. However, the defendants correctly

note that the plaintiffs have not specifically identified a single “test that is missing or incorrectly

calculated” out of the “551 scientific studies and other reports referenced in the [b]ackground

[d]ocument.” Defs.’ Opp’n at 14. The plaintiffs’ non-specific request is similar to the

supplementation request denied in Franks v. Salazar, 751 F. Supp. 2d 62, 73-74 (D.D.C. 2010).

The plaintiffs in Franks challenged the Secretary of the Interior’s denial of elephant trophy

import licenses. Id. at 66. Pointing to an e-mail from an outside biologist to an agency official

alleging errors in the agency’s count of trophies taken from Mozambique, the plaintiffs sought

all documents relating to these alleged errors. Id. at 72-73. The court held that supplementation

was inappropriate because the plaintiffs failed to “offer[] nonspeculative grounds for their belief

that the requested documents exist, much less that the Service considered them.” Id. at 73-74.

          Here, the plaintiffs have failed to offer non-speculative grounds for believing that the

NTP excluded any calculations without explanation, or that the NTP’s reporting of results is so

inadequate that it impairs judicial review. The record shows that the NTP either performed the

recommended calculations and reported the results, or explained why it did not. See A.R. at

1172-75. This record is therefore sufficient to determine whether the agency acted arbitrarily

and capriciously. Thus, the plaintiffs’ request for the NTP’s independent analyses of data is

denied.

C.        Documents Relating to the Portier Letter and the ATSDR Cancer Policy Chart

          Finally, the plaintiffs request that they be provided “all non-privileged documents relating

to the ATSDR Cancer Policy Chart and the Portier Letter.” Pls.’ Reply at 11. Although the

plaintiffs’ request for these documents was initially couched as a discovery request, Pls.’ Mem.

                                                   12
at 9, the plaintiffs request in their reply that documents be made part of the administrative record,

Pls’ Reply at 9. Accordingly, the Court will address these requests under the standards for

supplementing the administrative record or for the inclusion of extra-record evidence.

       1.      Documents Relating to the Portier Letter

       The plaintiffs seek to include in the administrative record “documents relating to the May

6, 2010 letter from Dr. Christopher Portier, Director of the [ATSDR,] to the Secretary of

[HHS],” Pls.’ Mem. at 3, including “drafts of the letter, requests to Dr. Portier for a letter, and

documents relating to consideration of the letter by Secretary Sibelius,” Pls.’ Mem., Ex. 4

(Request for Production of Documents) at 8. The Portier Letter is already included in the

administrative record. See A.R. at 2301a. In that letter, Dr. Portier opines that the NTP’s

decision to list styrene as “reasonably anticipated to be a human carcinogen” does not contradict

the ATSDR’s November 2010 Toxicology Profile on Styrene, which found that styrene “may

possibly be a human carcinogen.” Id.

       Contending that the Portier Letter was drafted “to rebut arguments made to counsel for

the Department of Health and Human Services,” the plaintiffs seek Dr. Portier’s drafts and other

intra-agency correspondence in order to reveal the “reasons and basis for that letter.” Pls.’ Reply

at 9-10. The defendants argue that any documents relating to the letter’s request, drafting, or

consideration are shielded by the deliberative process privilege because they are part of the

consultative process and reveal the Secretary’s mental processes. Defs.’ Opp’n at 14-15.

       “Two requirements are essential to the deliberative process privilege: [1] the material

must be predecisional and [2] it must be deliberative.” In re Sealed Case, 121 F.3d 729, 737

(D.C. Cir. 1997) (citations omitted). “[D]eliberative intra-agency memoranda and other such

records are ordinarily privileged, and need not be included in the record.” Amfac Resorts,

                                                  13
L.L.C. v. U.S. Dep’t of the Interior, 143 F. Supp. 2d 7, 13 (D.D.C. 2001). Documents that are

predecisional and deliberative are excluded from the administrative record because, under

arbitrary and capricious review, the reasonableness of the agency’s action “is judged in

accordance with its stated reasons.” In re Subpoena Duces Tecum Served on Office of

Comptroller of Currency, 156 F.3d 1279, 1279-80 (D.C. Cir. 1998). “[T]he actual subjective

motivation of agency decisionmakers is immaterial as a matter of law—unless there is a showing

of bad faith or improper behavior.” Id.

       The Court finds that the drafts of the Portier Letter and any correspondence relating to

that letter are both predecisional and deliberative. First, the Portier Letter is dated May 6, 2010,

and thus predates the signing of the Twelfth Report on Carcinogens on June 10, 2011. See

Compl. ¶ 69; A.R. at 2301a. The plaintiffs mistakenly assert that the letter is not predecisional

because its date falls five months after the release of the ATSDR’s Toxicological Profile for

Styrene. See Pls.’ Reply at 9. However, as shown in the document itself, the letter was written

in response to comments “by industry representatives in correspondence to the General Counsel”

of HHS regarding the NTP’s “proposed Report on Carcinogens,” a proposal which was later

adopted by the Secretary of HHS in the June 10, 2010 Report on Carcinogens. A.R. at 2301a;

see also Judicial Watch, Inc. v. FDA, 449 F.3d 141, 151 (D.C. Cir. 2006) (“We deem a document

predecisional if it was generated before the adoption of an agency policy . . . .”); Senate of Puerto

Rico ex. rel. Judiciary Comm. v. United States, 823 F.2d 574, 585 (D.C. Cir. 1987) (“A

document is ‘predecisional’ if it precedes, in temporal sequence, the ‘decision’ to which it

relates.”). Correspondence by agency staff with the Secretary of HHS that predated the June 10,

2010 Report is therefore predecisional.

                                                 14
       Second, the documents’ deliberative nature is apparent from the plaintiffs’ request. The

plaintiffs seek documents that reveal the Secretary’s consideration of the letter and whether she

requested it from Dr. Portier. See Pls.’ Mem. at 9. This attempt to “probe the mental processes

of the Secretary” is impermissible. United States v. Morgan, 313 U.S. 409, 422 (1941). As the

Circuit has pointed out, disclosure of this type of intra-agency communication is likely to stifle

the candor of consultations. See Russell v. Dep’t of the Air Force, 682 F.2d 1045, 1048 (D.C.

Cir. 1982) (noting that the privilege protects “creative debate and candid consideration of

alternatives” (citation omitted)). And the plaintiffs’ conclusory allegation that the Portier letter is

a “collusive document” does not persuade the Court that the agency was acting in bad faith such

that the agency’s motives should be probed. Thus, the plaintiffs’ request for access to

deliberative documents relating to the Portier Letter is denied.

       2.      Documents Relating to the ATSDR Cancer Policy Chart

       Finally, the plaintiffs seek to have included in the administrative record “[a]ll documents

relating to” (1) “the creation of the ATSDR Cancer Policy Chart” (“the Cancer Policy Chart,”

“the chart”); (2) “any consideration of changing [the chart]; and (3) “any consideration,

discussion, recommendation, or request to remove [the chart] from the ATSDR website.” Pls.’

Mem., Ex. 4 (Request for Production of Documents) at 8. The chart appeared as Appendix A of

the ATSDR’s 1993 Cancer Policy Framework. Compl. ¶ 21. It compares the various

classification standards for carcinogenicity between several federal agencies, including the NTP.

Pls.’ Reply, Ex. E (Letter from Peter L. de la Cruz to Mark B. Childress, December 20, 2010,

Enclosure B) at 22.

       The plaintiffs claim that the chart demonstrates a contradiction between the NTP’s and

the ATSDR’s carcinogenicity standards. Compl. ¶ 21. The plaintiffs also argue that the

                                                  15
documents relating to the chart were placed in issue by the defendants in their Opposition to

Plaintiffs’ Motion for a Preliminary Injunction, and that these documents should have been

included in the administrative record. Pls.’ Reply at 10-11. In response, the defendants argue

that the requested documents are (1) extra-record evidence requiring a showing of bad faith or

improper agency behavior, (2) irrelevant, and (3) privileged as deliberative documents. Defs.’

Opp’n at 4, 16.

       The Court must first determine whether the plaintiffs are requesting extra-record

evidence or supplementary material that was actually before the agency. The plaintiffs do not

allege that the NTP possessed any of the ATSDR’s documents concerning the chart’s creation in

1993, or that the NTP considered these documents in deciding to list styrene. The Court

therefore agrees with the defendants that these documents, created by a separate agency, nearly

twenty years ago, are extra-record evidence. Thus, receipt of these documents would require a

“strong showing of bad faith or improper behavior,” Commercial Drapery, 133 F.3d at 7, or an

agency’s failure to examine all relevant factors or explain adequately the grounds for its

decision, IMS, 129 F.3d at 624.

       The plaintiffs have not made this strong showing. First, they allege neither bad faith nor

improper conduct. They instead argue that the defendants opened the door to extra-record

review by referring to the ATSDR’s Cancer Policy Chart in response to the plaintiffs’ motion for

a preliminary injunction. Pls.’ Reply. at 10. Yet, the plaintiffs offer no legal support for the

proposition that reference to documents in a litigation brief is a basis for extra-record review.

Indeed, this proposition is inconsistent with the Supreme Court’s instruction that “the focal point

for judicial review should be the administrative record already in existence, not some new record

made initially in the reviewing court.” Camp v. Pitts, 411 U.S. 138, 142 (1973) (per curiam).

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Second, the plaintiffs have not identified any specific factors that the agency failed to consider,

and which might be illuminated by the documents relating to the Cancer Policy Chart. And, as

the Portier Letter shows, the record already includes the agency’s stated explanation for any

apparent inconsistency between the NTP’s carcinogenicity standards and those of the ATSDR.

See Defs.’ Opp’n at 14; A.R. at 2301a. Finally, the chart is self-explanatory and provides a

sufficient basis for the Court to determine whether the NTP acted arbitrarily and capriciously in

its interpretation of the terms “reasonably anticipated to be” and “may probably be.” A.R. at

2301a. In sum, the plaintiffs have failed to rebut the presumption of regularity and failed to

demonstrate that the administrative record is so bare that extra-record evidence is needed to

make judicial review effective. The plaintiffs’ request for inclusion of the documents relating to

the ATSDR Cancer Policy Chart is accordingly denied.

                                             IV. CONCLUSION

           For the foregoing reasons, the Court concludes that the plaintiffs’ motion to supplement

the record must be granted in part and denied in part. Specifically, the motion is granted as to

the plaintiffs’ request for the subgroup reports of the Expert Panel. However, the plaintiffs’

motion to supplement the record with the NTP’s independent analyses and statistical calculations

of data from the styrene background document must be denied. The Court also concludes that

the plaintiffs’ motion to supplement the record must be denied with respect to documents relating

to the Portier Letter and the ATSDR Cancer Policy Chart as identified in the plaintiffs’ document

requests. See Pls.’ Mem., Ex. 4 (Plaintiffs’ First Request for Production of Documents) at 8-10.

           SO ORDERED this 30th day of March, 2012. 5

                                                                      REGGIE B. WALTON
                                                                      United States District Judge

5
    The Court will contemporaneously issue an order consistent with this memorandum opinion.

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