Am. Chemistry Council v. Nat'l Acad. of Scis.

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AMERICAN CHEMISTRY COUNCIL, INC., Plaintiff, v. NATIONAL ACADEMY OF SCIENCES et al., Defendants.

Civil Action No. 23-2113 (JDB)

United States District Court, District of Columbia

March 15, 2024

MEMORANDUM OPINION

JOHN D. BATES UNITED STATES DISTRICT JUDGE

This case concerns a peer review committee convened by the National Academy of Sciences (the “Academy” or “NAS”) under contract with the Environmental Protection Agency (“EPA”) to evaluate the agency's draft hazard assessment for the chemical formaldehyde. The American Chemistry Council (“ACC”), a trade association of chemical manufacturers, has sued the Academy and EPA under the Mandamus Act and the Administrative Procedure Act claiming that the committee was convened in violation of the Federal Advisory Committee Act. Before the Court is ACC's motion for a preliminary injunction and each defendant's motion to dismiss. The Court will dismiss the Academy because it is a private entity over which the Court cannot exercise mandamus jurisdiction. The Court will also dismiss EPA because ACC lacks standing to prosecute its claims against the agency. Accordingly, the Court will deny ACC's motion for a preliminary injunction as moot.

Background

I. Statutory Background

The Federal Advisory Committee Act (“FACA”) regulates the establishment, termination, operation, and use of committees charged with providing advice to the federal government. See 5 U.S.C. § 1002. Enacted in 1972, “[i]ts purpose was to ensure,” among other things, that such committees' “creation, operation, and duration be subject to uniform standards and procedures.” Pub Citizen v. U.S. Dep't of Just., 491 U.S. 440, 446 (1989). The requirements of FACA apply to any government “advisory committee”-a term of art under FACA that refers to committees “established by statute” or “established or utilized by the President [or by] . . . one or more agencies.” 5 U.S.C § 1001(2)(A).

Every advisory committee must be established pursuant to a charter filed with the General Services Administration, which sets out, inter alia, the committee's objectives, scope, the “agency or official to whom the committee reports,” the frequency of its meetings, and the date on which it will terminate. 5 U.S.C. § 1008(c)(2). A committee must be chaired by an officer or employee of the federal government, without whom the committee cannot meet. Id. § 1009(e). The Act also creates a presumption of open access to meetings and records. Id. § 1009(a)-(d). Finally, FACA mandates that advisory committees be “fairly balanced in terms of the points of view represented and the functions to be performed,” id. § 1004(b)(2), and that “advice and recommendations of the advisory committee . . . not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee's independent judgment,” id. § 1004(b)(3).

In 1997, the D.C. Circuit held that the Academy was “quasi-public” and therefore its committees were “utilized” by federal agencies and subject to FACA. Animal Legal Def. Fund v. Shalala, 104 F.3d 424, 431 (D.C. Cir. 1997). Congress almost immediately amended FACA to clarify that committees “created by the National Academy of Sciences or the National Academy of Public Administration” were not advisory committees. 5 U.S.C. § 1001(B)(ii); see also 143 Cong. Rec. H10579 (daily ed. Nov. 9, 1997) (statement of Rep. Horn) (explaining Congress's purpose of overruling Animal Legal Defense Fund). At the same time, Congress decided to place certain similar public disclosure and fair balance requirements on committees of the Academy. See 5 U.S.C. § 1014.

The statute regulating Academy committees-known as Section 15-follows a similar pattern as FACA, although it has some key differences. To begin, Section 15 requires the Academy to take public input on committee nominations. Specifically, the statute requires the Academy to “provide public notice” and “brief biographies” of individuals it plans to appoint to a committee, and to give the public a “reasonable opportunity” to comment before appointments are made. 5 U.S.C. § 1014(b)(1). The Academy must further “make its best efforts to ensure that,” Id. § 1014(b)(1), committee members do not have any conflicts of interest “relevant to the functions to be performed” unless such conflict is “promptly and publicly disclosed and the Academy determines that the conflict is unavoidable,” id. § 1014(b)(1)(A). The Academy must also “make its best efforts to ensure that,” id. § 1014(b)(1), the “committee membership is fairly balanced as determined by the Academy to be appropriate for the functions to be performed,” and “the final report of the Academy will be the result of the Academy's independent judgment.” Id. § 1014(b)(1)(B)-(C); see 41 C.F.R. § 102-3.185 (2024) (GSA regulations concerning the same).

Section 15 also requires the Academy to “provide public notice of committee meetings” and to “ensure that meetings of the committee to gather data from individuals who are not officials, agents, or employees of the Academy are open to the public.” 5 U.S.C. § 1014(b)(2)-(3). But Section 15 permits the Academy to close non-data-gathering meetings as long as it provides a “brief summary” identifying “the committee members present, the topics discussed, materials made available to the committee, and other matters the Academy determines should be included.” Id. § 1014(b)(4). If any of the above requirements are not met-or if the committee was “subject to any actual management or control by an agency or an officer of the Federal Government”-an agency “may not use” an Academy committee's “advice or recommendation.” Id. § 1014(a).

II. Factual Background

At issue here are several challenges to an Academy committee engaged to conduct external peer review on an EPA assessment of the chemical formaldehyde. As part of its Integrated Risk Information System (“IRIS”), EPA reviews data on potentially hazardous chemicals and develops assessments identifying levels of exposure at which humans face higher risk of deleterious health effects and cancer. See Am. Compl. [ECF No. 15] ¶ 28; Integrated Risk Information System (IRIS); Health Risk Assessment; Guidelines, etc., 53 Fed.Reg. 20162, 20162-64 (June 2, 1988). In developing those assessments, EPA takes public comment, solicits peer review, and seeks input from federal stakeholders. See EPA, Basic Information About the Integrated Risk Information System, https://www.epa.gov/iris/basic-information-about-integrated-risk-information-system#process [https://perma.cc/WC53-5CH2]. Once complete, the assessments are compiled in IRIS and provide an “important source of toxicity information used by EPA, state and local health agencies, other federal agencies, and international health organizations.” Am. Compl. ¶ 28.

In 1989, EPA first produced an IRIS assessment of formaldehyde-a “widely present” chemical “used in many manufactured goods,” “formed by combustion sources,” and “produced in humans.” NAS Rep. [ECF No. 17-3] at 1; see Am. Compl. ¶ 1. Despite its ubiquity, EPA identified formaldehyde as a “probable human carcinogen.” NAS Rep. at 1. In the 2000s, EPA began the “process of re-evaluating the health impacts of formaldehyde,” culminating in a 2010 draft IRIS assessment for the chemical. Am. Compl. ¶ 43. As part of the IRIS process, EPA asked the Academy to conduct an independent peer review. Id. The committee's report was critical of the assessment and concluded that it was not methodologically sound. See id. ¶ 44. Over the next decade, EPA worked on revising the draft assessment. See id. ¶ 46-48.

EPA finished a new draft assessment in 2022 and again engaged the Academy to convene a peer review committee. Am. Compl. ¶ 48. The 2022 Task Order required the Academy to “establish an expert panel of up to 12 experts following [the Academy's] procedures on committee composition, balance, and conflict of interest.” Task Order [ECF No. 17-5] at 2. The committee would be filled after taking “public nominations for panel members and solicit[ing] comments on the panel.” Id. The committee's task, as outlined in the agreement, was to “evaluat[e] whether the scientific literature was adequately evaluated by EPA, and whether appropriate methods were used to synthesize the current state-of-the science”-pursuant to specific “charge questions” submitted by EPA. Id. at 2. The committee was “not” to “conduct an independent assessment separately from the IRIS document,” nor to “comment on the broader aspects of the IRIS Program.” Id. at 2; see Am. Compl. ¶ 95.

Pursuant to the Task Order, the Academy solicited nominations for members from the public, see Mem. in Supp. of Mot. for Prelim. or Permanent Inj. Relief [ECF No. 17-1] (“ACC Mot.”) at 7; Call for Nominations Email [ECF No. 17-6] at *3-7, as well as from EPA, Am. Compl. ¶¶ 98-100. The Academy assembled a proposed peer review committee and provided the public twenty calendar days (fourteen business days) to comment on a provisional committee membership. Am. Compl. ¶ 93. To facilitate the public review, the Academy provided brief biographies of the potential members. See id. ¶ 82.

The Academy ultimately selected a committee of scientists to review the assessment. The committee comprised several epidemiologists, but not any with significant “backgrounds and expertise in private sector industrial toxicology and industrial epidemiology.” Am. Compl ¶ 64. The committee also included members with historical ties to EPA and the IRIS process. For example, one member previously “chaired [an Academy] Committee hosting a workshop to ‘support development of EPA's IRIS Toxicological Reviews,'” and served as a “‘faculty fellow to the IRIS Program from 2011 to 2013,' [wher...