Envtl. Def. Fund v. U.S. Envtl. Prot. Agency, 4:21-cv-03-BMM

CourtUnited States District Courts. 9th Circuit. United States District Court (Montana)
Writing for the CourtBrian Morris, Chief District Judge United States District Court
PartiesENVIRONMENTAL DEFENSE FUND; MONTANA ENVIRONMENTAL INFORMATION CENTER; and CITIZENS FOR CLEAN ENERGY, Plaintiffs, v. U.S. ENVIRONMENTAL PROTECTION AGENCY; and ANDREW R. WHEELER, in his official capacity as Administrator of the U.S. Environmental Protection Agency, Defendants.
Docket Number4:21-cv-03-BMM
Decision Date27 January 2021

as Administrator of the U.S. Environmental Protection Agency, Defendants.



January 27, 2021



Environmental Defense Fund ("EDF"), Montana Environmental Information Center ("MEIC"), and Citizens for Clean Energy ("CCE") (collectively, "Plaintiffs") brought this action against the U.S. Environmental Protection Agency ("EPA") and Andrew R. Wheeler in his official capacity as Administrator of EPA ("Federal Defendants") to challenge an EPA rulemaking. (Doc. 1). Plaintiffs allege two counts: that the final rule itself was unlawful; and that EPA's decision to make the final rule effective on publication was unlawful. (Doc. 1 at 10-13).

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Plaintiffs filed a Motion to Expedite their Motion for Partial Summary Judgment. (Doc. 7). Plaintiffs also filed concurrently a Motion for Partial Summary Judgment centered on the effective date count. (Doc. 8). Plaintiffs seek an order declaring unlawful and setting aside EPA's decision to make the final rule effective immediately and declaring that the final rule should remain ineffective until 30 days from its publication date. (Doc. 8 at 1-2; Doc. 9 at 3-4).

Plaintiffs proposed an expedited briefing schedule for their summary judgment motion. (Doc. 7 at 3). Federal Defendants disagreed with the justification for expedited resolution, but asserted they would "nevertheless agree with the briefing schedule set forth" in Plaintiffs' motion. (Doc. 16 at 1). The Court granted the Motion to Expedite. (Doc. 18). The Motion for Partial Summary Judgment proves fully briefed and ripe. (Docs. 8, 9, 24, 27).

Factual Background

President Richard Nixon established EPA in 1970 "to make a coordinated attack on the pollutants which debase the air we breathe, the water we drink, and the land that grows our food." Reorganization Plan No. 3 of 1970 (July 9, 1970). William D. Ruckelshaus, the first EPA Administrator, further elaborated that EPA has a "broad responsibility for research, standard-setting, monitoring and enforcement with regard to five environmental hazards: air and water pollution,

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solid waste disposal, radiation, and pesticides." EPA's First Administrator on Establishment of EPA, Press Release (Dec. 16, 1970).

EPA's mission remains "to protect human health and the environment." EPA achieves that mission through the implementation of these core environmental laws: the Clean Air Act ("CAA"), 42 U.S.C. §§ 7401-7671q; the Clean Water Act ("CWA"), 33 U.S.C. §§ 1251-1387; the Safe Drinking Water Act ("SDWA"), 42 U.S.C. §§ 300f-300j-26; the Toxic Substances Control Act ("TSCA"), 15 U.S.C. §§ 2601-2697; the Emergency Planning and Community Right-to-Know Act ("EPCRA"), 42 U.S.C. §§ 11001-11050; and the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. §§ 136-136y, among others.

EPA implements these substantive environmental statutes by establishing quantitative limits and standards to protect public health and the environment. Congress directed EPA through those statutes to use the "latest," "generally accepted," and "best available" science to inform the agency's decisions. For one example, the CAA requires EPA to establish science-based standards to control air pollution to protect public health and welfare. See 42 U.S.C. § 7401(b)(1); Am. Lung Ass'n v. Envtl. Prot. Agency, No. 19-1140, 2021 WL 162579, at *25-*26 (D.C. Cir. Jan. 19, 2021) (describing the purpose and history of the CAA).

EPA sets air pollution standards known as air quality criteria that must "accurately reflect the latest scientific knowledge." 42 U.S.C. § 7408(a)(2). EPA

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must consider "all identifiable effects [of air pollutants] on public health and welfare" and "include information" on certain science-based factors "to the extent practicable" when it establishes air quality criteria. Id. EPA must then use these criteria to adopt National Ambient Air Quality Standards ("NAAQS") at levels requisite to protect public health with an adequate margin of safety. See id. § 7409(b). The CAA further requires EPA to evaluate health risks and effects of hazardous air pollutants ("HAPs") and to set emission standards to reduce such risks using science-based considerations. See id. § 7412. As part of the residual risk requirements, EPA also must investigate and report on "the actual health effects with respect to persons living in the vicinity of sources," and "any available epidemiological or other health studies" regarding the effects of HAPs. Id. § 7412(f)(1)(C).

EPA relies on a wide range of scientific research to implement its standards and rules. Such research includes epidemiological studies that use dose-response data to link exposure to a pollutant, contaminant, or substance to a public health or environmental harm. Some of these epidemiological studies—particularly studies that examine small populations or populations with unique health challenges—use data that includes confidential medical or other personally identifiable information. Such information could be used to identify study participants. Federal law generally prohibits public disclosure of these data to protect the privacy of those

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who participated in those studies. See, e.g., Health Insurance Portability and Accountability Act ("HIPAA") Privacy Rules, 45 C.F.R. Parts 160 and 164, Subparts A & E (establishing safeguards to protect the privacy of personal health information, and setting limits and conditions on the uses and disclosures that may be made of such information without patient authorization); 21st Century Cures Act, 42 U.S.C. § 241 (requiring government agencies to provide a certificate of confidentiality to protect the privacy of individuals participating in certain research); Privacy Act of 1974, 5 U.S.C. § 552a (precluding disclosure of personally identifiable information or records by government agencies except in very limited enumerated circumstances).

As a result, public health researchers frequently make confidential the data that underlies their findings. The scientific community has developed methodologies, such as peer review, to validate the result of studies even when the underlying data remains unavailable publicly. See Jeremy Berg, Philip Campbell, Veronique Kiermer, Natasha Raikhel & Deborah Sweet, Joint Statement on EPA Proposed Rule and Public Availability of Data, Nature (Apr. 30, 2018). EPA long has relied on these proven review mechanisms to ensure that the public health studies that underly regulatory decisions prove scientifically valid. The D.C. Circuit previously upheld a challenge to EPA's practice of relying on studies with confidential underlying data. See Am. Trucking Ass'ns, Inc. v. EPA, 283 F.3d 355,

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372 (D.C. Cir. 2002). The D.C. Circuit concluded, in part, that "requiring agencies to obtain and publicize the data underlying all studies on which they rely" would be "impractical and unnecessary." Id.

EPA Rulemaking

On April 30, 2018, EPA proposed a rule to "enhanc[e] the transparency and validity of the scientific information relied upon by EPA" in its regulatory decision-making. Strengthening Transparency in Regulatory Science, 83 Fed. Reg. 18,768, 18,768-69 (Apr. 30, 2018) ("First Proposed Rule"). The First Proposed Rule would require EPA to ensure that dose response data and models underlying "pivotal regulatory science" were publicly available for validation and analysis. See id at 18,770. EPA defined "pivotal regulatory science" as "studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point of departure from which a reference value is calculated." Id.

EPA sought to "change agency culture and practices regarding data access" by "exercis[ing] its discretionary authority to establish a policy that would preclude it from using [non-public] data in future regulatory actions." Id. at 18,769 n.3. To that end, EPA's First Proposed Rule would preclude the use of scientific studies when making regulatory decisions on the basis that the underlying data were not publicly available. The First Proposed Rule included a provision that would permit

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the EPA Administrator to "exempt significant regulatory decisions" from the rule, but it failed to provide a standard to apply that exemption. Id. at 18,772.

EPA proposed to promulgate the First Proposed Rule "under the authority of the statutes it administers." Id. at 18,768 (citing CAA, 42 U.S.C. §§ 7403, 7601(a); CWA, 33 U.S.C. §§ 1254, 1361; SDWA, 42 U.S.C. §§ 300j-1, 300j-9(a)(1); Resource Conservation and Recovery Act ("RCRA"), 42 U.S.C. §§ 6912(a)(1), 6979; Comprehensive Environmental Response, Compensation, and Liability Act ("CERCLA"), 42 U.S.C. §§ 9616, 9660; EPCRA, 42 U.S.C. § 11048; FIFRA, 7 U.S.C. §§ 136r(a), 136w; and TSCA, 15 U.S.C. § 2609).

EPA extended the comment period for the First Proposed Rule on May 25, 2018. See 83 Fed. Reg. 24,255, 24,256 (May 25, 2018). EPA also expanded its claim of authority to promulgate the First Proposed Rule to include the Federal Housekeeping Statute "in addition to the authorities" previously listed. Id. The Federal Housekeeping Statute provides "[t]he head of an Executive department or military department" with authority to "prescribe regulations for the government of his [or her] department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property." 5 U.S.C. § 301; see also Chrysler Corp. v. Brown, 441 U.S. 281, 310 (1979) (describing the statute as "simply a grant of authority to the agency to regulate its own affairs").

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On March 18, 2020, EPA issued a Supplemental Notice of Proposed Rulemaking "to...

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