Pub. Emps. for Envtl. Repsonsibility v. U.S. Envtl. Prot. Agency

PUBLIC EMPLOYEES FOR ENVIRONMENTAL REPSONSIBILITY, Plaintiff, v. U.S. ENVIRONMENTAL PROTECTION AGENCY, Defendant.

Civil Action No. 18-cv-2219 (BAH)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

June 18, 2021

Chief Judge Beryl A. Howell

MEMORANDUM OPINION

The Environmental Protection Agency ("EPA") uses an Integrated Risk Information System ("IRIS") program to analyze selected chemicals found in the environment to identify and characterize hazards to human health, with the results of this analysis released in final public assessments to guide EPA policymaking and inform the general public. In January 2018, in testimony before the Senate Committee on the Environment and Public Works, then-EPA Administrator Scott Pruitt made comments construed as confirming EPA's preparation of a new version of a long-delayed IRIS formaldehyde assessment, which, while not final, was ready to be publicly released for comment and peer review, but was being "held up" and therefore had not yet been released. Compl. ¶ 3, ECF No. 1. Prompted by this congressional testimony, plaintiff Public Employees for Environmental Responsibility ("PEER"), "a non-profit organization dedicated to research and public education concerning the activities of federal, state, and local governments," id. ¶ 2, submitted a request, pursuant the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, to EPA for, inter alia, this public-ready version of the formaldehyde assessment referenced by then-Administrator Pruitt, and subsequently filed the instant lawsuit to obtain this agency record. EPA has withheld in full the version of the IRIS formaldehyde assessment referenced in the congressional testimony—the only document remaining at issue in this lawsuit—as protected by the deliberative process privilege and therefore exempt from disclosure under FOIA's Exemption 5, id. § 552(b)(5).

Pending before the Court are the parties' cross-motions for summary judgment. See Def.'s Mot. Summ. J. ("Def.'s Mot."), ECF No. 21; Pl.'s Cross-Mot. Summ. J. ("Pl.'s Mot."), ECF No. 23. For the reasons set forth below, EPA's Motion for Summary Judgment is granted and plaintiff's Cross-Motion for Summary Judgment is denied.

I. BACKGROUND

Pertinent background underlying plaintiff's FOIA request is described, followed by review of the FOIA request and the initiation of the instant lawsuit.¹

A. EPA's IRIS Program

EPA's IRIS program "analyzes selected chemicals found in the environment to identify and characterize hazards to human health." Def.'s Mem. Supp. Mot. Summ. J. ("Def.'s Mem.") at 1, ECF No. 21. According to EPA, the program's primary purpose is to produce assessments, which are documents that "[identify] relevant studies" and "synthesi[ze] . . . evidence from identified studies across human, animal, and mechanistic lines of information" to identify human health hazards. Def.'s Mot., Ex. 2, Decl. of Dr. Jennifer Orme-Zavaleta ("1st Orme-Zavaleta Decl.") ¶¶ 1, 15, ECF No. 21-2. By "identifying the human health hazard of a chemical, and theaccompanying evaluation of dose-response information for those hazards," IRIS assessments "provide the scientific foundation for decision-making to protect public health." Id. ¶ 7. IRIS assessments "are part of the EPA's broader policy-making and decision-making process," and are "available for use by EPA's program and regional offices, as well as other stakeholders, to inform Agency decisions under relevant statutory authorities." Def.'s Reply Supp. Mot. Summ. J., Ex. 2, Second Decl. of Doctor Jennifer Orme-Zavaleta ("2d Orme-Zavaleta Decl.") ¶ 8, ECF No. 27-2. "Each IRIS assessment can cover a [single] chemical, a group of related chemicals, or a complex mixture." 1st Orme-Zavaleta Decl. ¶ 7. EPA is in the process of developing 16 different IRIS chemical assessments, including the formaldehyde assessment at issue in the instant lawsuit. Id.

Completion of an assessment for a given chemical under the IRIS program comprises seven distinct steps, from initial research, analysis and drafting, to internal and interagency review, to public release of an interim version for public comment and peer review, to further revision and review in light of such comments, to ultimate release of the final assessment, which is the agency's definitive statement on the health risks of the chemical under analysis.² During Step One ("Draft Development"), EPA first "undertakes internal scoping to identify EPA program and regional office needs for an assessment." Id. ¶ 8. Then, "[p]roblem formulation frames the scientific questions that will be the focus of systematic reviews conducted as part of assessment development." Id. Next, "[d]raft development begins with a comprehensive search and systematic review of the scientific literature," after which "EPA provides preliminary assessment materials to the public and an opportunity for public input on these materials." Id. At Step Two ("Agency Review"), "[s]cientists in EPA's program offices and regions review thedraft assessment," and the draft assessment is revised as needed. Id. At Step 3 ("Interagency Science Consultation"), "[o]ther federal agencies, including the Executive Office of the President, review the draft assessment," and the draft assessment is again revised as needed. Id. Step Four ("Public Comment and External Peer Review"), provides that the draft assessment "is released for public review and comment" as well as "external peer review." Id. Next, at Step Five ("Revise Assessment"), "[t]he IRIS Program revises the assessment to address peer review comments" and "prepare[s] a written response-to-comment document." Id. At Step Six ("Final Agency Review"), the revised assessment is again "reviewed by EPA's program offices and regions, other federal agencies, and the Executive Office of the President." Id. Finally, at Step Seven ("Final Assessment"), "[t]he final IRIS assessment is posted to the IRIS website." Id.

B. The IRIS Formaldehyde Assessment

The IRIS formaldehyde assessment at issue has been in process for well over a decade, and, according to plaintiffs, dates back to 1997. See Pl.'s Mem. Supp. Cross-Mot. Summ. J. & Opp'n Def.'s Mot. Summ. J. ("Pl.'s Opp'n") at 2, ECF No. 23. In 2005, EPA announced that the formaldehyde assessment would be sent "for external review during fiscal years 2006 and 2007," referencing IRIS Step Four, but that deadline was not met. Id. (omissions in original) (quoting GOV'T ACCOUNTABILITY OFFICE, GAO-08-440, LOW PRODUCTIVITY AND NEW INTERAGENCY REVIEW PROCESS LIMIT THE USEFULNESS AND CREDIBILITY OF EPA'S INTEGRATED RISK INFORMATION SYSTEM 37 (2008), https://www.gao.gov/products/GAO-08-440).

In 2010, EPA released a draft formaldehyde assessment at Step Four of the IRIS process, thereby providing the opportunity for public comment on and external peer review, and this document remains publicly available on EPA's website. 2d Orme-Zavaleta Decl. ¶¶ 4-5. In 2011, the National Academy of Sciences ("NAS") conducted a peer review of the draft andprovided "significant comments" necessitating substantive revisions to the draft. Id. ¶ 6.³ In response to those comments, IRIS "never finalized" "the 2010 [draft] [a]ssessment," id., and instead began working on a new version of the formaldehyde assessment to address the 2011 NAS peer review comments, returning the formaldehyde assessment to Step One of the IRIS program, requiring EPA to "repeat Agency review and interagency science consultation before being released" for public comment and renewed peer review. Id. (internal quotation marks omitted).⁴ Since 2011, the new draft formaldehyde assessment has not yet undergone Steps Two and Three—Agency Review and Interagency Science Consultation—and therefore has not yet been advanced to IRIS Step Four or released for public review. See 2d Orme-Zavaleta Decl. ¶¶ 6-7.

As of March 2019, EPA was "no longer working on the [IRIS] Formaldehyde Assessment," because "other chemicals ha[d] been identified as higher priorities for the IRIS assessment process at th[at] time," although a separate EPA office had begun working on "a risk evaluation for formaldehyde under the Toxic Substances Control Act." 1st Orme-Zavaleta Decl. ¶ 9; Def.'s Suppl. Br., Ex. 1, Third Decl. of Doctor Jennifer Orme-Zavaleta ("3d Orme-Zavaleta Decl.") ¶ 4, ECF No. 33-1. On March 26, 2021, however, EPA announced that "the IRIS assessment of formaldehyde . . . ha[d] been unsuspended, and that a public milestone timeline"for the formaldehyde assessment would be provided in June 2021. 3d Orme-Zavaleta Decl. ¶¶ 3-4; see also id., Ex. 1, Mar. 11, 2021 Memo from Jennifer Orme-Zavaleta, Ph.D., to Acting Assistant Administrators, Acting Regional Administrators, and Deputies of EPA, at 2 ("[EPA] will unsuspend the IRIS assessment of formaldehyde and will add formaldehyde to the current IRIS agenda. The next step for this assessment is agency review.").

C. January 2018 Meeting of the American Chemistry Council and IRIS Staff

Meanwhile, more than a year before EPA's suspension of the IRIS formaldehyde assessment, while revisions were still underway following the NAS peer review, the Formaldehyde Panel of the American Chemistry Council ("ACC") met, on January 24, 2018, with IRIS staff to discuss the status of the formaldehyde assessment. See Pl.'s Opp'n at 3; see also Pl.'s Cross-Mot., Ex. 1, Decl. of Kevin Bell ("Bell Decl."), ECF No. 23-1; 2d Orme-Zavaleta Decl. ¶ 9. According to EPA, "[t]he IRIS Program . . . frequently [meets] with members of the public to hear stakeholder perspectives," such as "new or ongoing research initiatives," 2d Orme-Zavaleta Decl. ¶ 9, and requests for such meetings are publicly disclosed on IRIS's website, see id. ¶ 9 & n.8; IRIS Calendar: Meetings Requested by Specific Members of the Public, U.S. ENVT'L PROTECTION AGENCY, https://iris.epa.gov/Events/#stakeholderMeetings (last visited June 9, 2021). EPA "confirm[s]" that, although the draft assessment was discussed "at th[e] [January 24, 2018] meet...