Styrene Information and Research Center, Inc. v. Sebelius ( 2012 )

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