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Safer Chemicals v. U.S. Environmental Protection Agency

United States Court of Appeals, Ninth Circuit

November 14, 2019

Safer Chemicals, Healthy Families; Alaska Community Action On Toxics; Environmental Health Strategy Center; Environmental Working Group; Learning Disabilities Association of America; Sierra Club; Union of Concerned Scientists; United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO/CLC; WE ACT for Environmental Justice; Asbestos Disease Awareness Organization; Vermont Public Interest Research Group, Petitioners,
v.
U.S. Environmental Protection Agency; Andrew Wheeler, [*] Administrator, United States Environmental Protection Agency, Respondents, American Chemistry Council; American Coatings Association; American Coke and Coal Chemicals Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; American Petroleum Institute; Battery Council International; Chamber of Commerce of the United States of America; EPS Industry Alliance; IPC International, Inc., doing business as IPC Association Connecting Electronics Industries; National Association of Chemical Distributors; National Mining Association; Polyurethane Manufacturers Association; Silver Nanotechnology Working Group; Society of Chemical Manufacturers and Affiliates; Styrene Information and Research Center; Utility Solid Waste Activities Group, Respondents-Intervenors. Environmental Defense Fund, Petitioner,
v.
U.S. Environmental Protection Agency; Andrew Wheeler, Administrator, United States Environmental Protection Agency, Respondents, American Chemistry Council; American Coatings Association; American Coke and Coal Chemicals Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; American Petroleum Institute; Battery Council International; Chamber of Commerce of the United States of America; EPS Industry Alliance; IPC International, Inc., doing business as IPC Association Connecting Electronics Industries; National Association of Chemical Distributors; National Mining Association; Polyurethane Manufacturers Association; Silver Nanotechnology Working Group; Society of Chemical Manufacturers and Affiliates; Styrene Information and Research Center; Utility Solid Waste Activities Group, Respondents-Intervenors. Alliance of Nurses for Healthy Environments; Cape Fear River Watch; Natural Resources Defense Council, Petitioners,
v.
U.S. Environmental Protection Agency, Respondent, American Chemistry Council; American Coatings Association; American Coke and Coal Chemicals Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; American Petroleum Institute; Battery Council International; Chamber of Commerce of the United States of America; EPS Industry Alliance; IPC International, Inc., doing business as IPC Association Connecting Electronics Industries; National Association of Chemical Distributors; National Mining Association; Polyurethane Manufacturers Association; Silver Nanotechnology Working Group; Society of Chemical Manufacturers and Affiliates; Styrene Information and Research Center; Utility Solid Waste Activities Group, Respondents-Intervenors. Alliance of Nurses for Healthy Environments; Cape Fear River Watch; Natural Resources Defense Council, Petitioners,
v.
U.S. Environmental Protection Agency, Respondent, American Chemistry Council; American Coatings Association; American Coke and Coal Chemicals Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; American Petroleum Institute; Battery Council International; Chamber of Commerce of the United States of America; EPS Industry Alliance; IPC International, Inc., doing business as IPC Association Connecting Electronics Industries; National Association of Chemical Distributors; National Mining Association; Polyurethane Manufacturers Association; Silver Nanotechnology Working Group; Society of Chemical Manufacturers and Affiliates; Styrene Information and Research Center; Utility Solid Waste Activities Group, Respondents-Intervenors. Environmental Defense Fund, Petitioner,
v.
U.S. Environmental Protection Agency; Andrew Wheeler, Administrator, United States Environmental Protection Agency, Respondents, American Chemistry Council; American Coatings Association; American Coke and Coal Chemicals Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; American Petroleum Institute; Battery Council International; Chamber of Commerce of the United States of America; EPS Industry Alliance; IPC International, Inc., doing business as IPC Association Connecting Electronics Industries; National Association of Chemical Distributors; National Mining Association; Polyurethane Manufacturers Association; Silver Nanotechnology Working Group; Society of Chemical Manufacturers and Affiliates; Styrene Information and Research Center; Utility Solid Waste Activities Group, Respondents-Intervenors. Safer Chemicals, Healthy Families; Alaska Community Action On Toxics; Environmental Health Strategy Center; Environmental Working Group; Learning Disabilities Association of America; Sierra Club; Union of Concerned Scientists; United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO/CLC; WE ACT for Environmental Justice; Asbestos Disease Awareness Organization; Vermont Public Interest Research Group, Petitioners,
v.
U.S. Environmental Protection Agency; Andrew Wheeler, Administrator, United States Environmental Protection Agency, Respondents, American Chemistry Council; American Coatings Association; American Coke and Coal Chemicals Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; American Petroleum Institute; Battery Council International; Chamber of Commerce of the United States of America; EPS Industry Alliance; IPC International, Inc., doing business as IPC Association Connecting Electronics Industries; National Association of Chemical Distributors; National Mining Association; Polyurethane Manufacturers Association; Silver Nanotechnology Working Group; Society of Chemical Manufacturers and Affiliates; Styrene Information and Research Center; Utility Solid Waste Activities Group, Respondents-Intervenors.

          Argued and Submitted May 16, 2019

          On Petition for Review of an Order of the Environmental Protection Agency, EPA Nos. EPA-HQ-OPPT-2016-0636, EPA-HQ-OPPT-2016-0654

          Sarah C. Tallman (argued), Natural Resources Defense Council, Chicago, Illinois; Nancy S. Marks, Natural Resources Defense Council, New York, New York; for Petitioners Alliance of Nurses for Healthy Environments; Cape Fear River Watch; and Natural Resources Defense Council.

          Robert M. Sussman, Sussman and Associates, Washington, D.C.; for Petitioners Safer Chemicals, Healthy Families; Asbestos Disease Awareness Organization; and Vermont Public Interest Research Group.

          Robert P. Stockman, Environmental Defense Fund, Washington, D.C.; for Petitioner Environmental Defense Fund.

          Eve C. Gartner, Earthjustice, New York, New York; Tosh Sagar, Earthjustice, Washington, D.C.; for Petitioners Alaska Community Action on Toxics; Environmental Health Strategy Center; Environmental Working Group; Learning Disabilities Association of America; Sierra Club; Union of Concerned Scientists; and WE ACT for Environmental Justice.

          Randy S. Rabinowitz, OSH Law Project LLC, Washington D.C.; for Petitioner United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO/CLC.

          Samara M. Spence (argued) and Erica M. Zilioli, Environmental Defense Section, Environment and Natural Resources Division, United States Department of Justice, Washington, D.C.; Jonathan D. Brightbill, Deputy Assistant Attorney General; Jeffrey H. Wood, Acting Assistant Attorney General; Laurel Celeste, Office of the General Counsel, United States Environmental Protection Agency, Washington, D.C.; for Respondents.

          Peter D. Keisler (argued), Samuel B. Boxerman, Timothy K. Webster, C. Frederick Beckner III, Judah Prero, and Samina M. Bharmal, Sidley Austin LLP, Washington, D.C.; for Respondents-Intervenors American Chemistry Council; American Coke and Coal Chemicals Institute; American Petroleum Institute; American Forest & Paper Association; American Fuel & Petrochemical Manufacturers; Chamber of Commerce of the United States Of America; EPS Industry Alliance; IPC International, Inc.; National Association of Chemical Distributors; National Mining Association; and Silver Nanotechnology Working Group.

          David B. Weinberg, Martha E. Marrapese, and Roger H. Miksad, Wiley Rein LLP, Washington, D.C.; for Respondents-Intervenors American Coatings Association and Battery Council International.

          Donald P. Gallo, Axley Brynelson LLP, Waukesha, Wisconsin; for Respondent-Intervenor Polyurethane Manufacturers Association.

          James W. Conrad, Jr., Conrad Law & Policy Counsel, Washington, D.C.; for Respondent-Intervenor Society of Chemical Manufacturers and Affiliates.

          Peter L. de la Cruz, Keller and Heckman LLP, Washington, D.C.; for Respondent-Intervenor Styrene Information and Research Center, Inc.

          Douglas H. Green and Allison D. Foley, Venable LLP, Washington, D.C.; for Respondent-Intervenor Utility Solid Waste Activities Group.

          Richard Moskowitz and Taylor Hoverman, American Fuel & Petrochemical Manufacturers, Washington, D.C.; for Respondent-Intervenor American Fuel & Petrochemical Manufacturers.

          Steven P. Lehotsky and Michael B. Schon, U.S. Chamber Litigation Center, Washington, D.C.; for Respondent-Intervenor Chamber of Commerce of the United States of America.

          David S. Muraskin and Leah M. Nicholls, Public Justice P.C., Washington, D.C.; for Amici Curiae American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Public Health Association.

          Paul Olszowka, Barnes & Thornburg LLP, Chicago, Illinois; for Amicus Curiae People for the Ethical Treatment of Animals.

          Before: Diarmuid F. O'Scannlain and Michelle T. Friedland, Circuit Judges, and William H. Pauley III, [**] District Judge.

         SUMMARY [***]

         Environmental Law

         The panel dismissed in part, granted in part, and denied in part petitions for review brought by a variety of environmental groups and other organizations, seeking review of a rule promulgated by the United States Environmental Protection Agency ("EPA") establishing a process to evaluate the health and environmental risks of chemical substances.

         The EPA promulgated the Risk Evaluation Rule pursuant to the Toxic Substances Control Act ("TSCA").

         Petitioners argued that TSCA required EPA to evaluate risks from uses of a chemical substance collectively, and that the Risk Evaluation Rule contradicted this mandate. The panel held that this challenge was not justiciable because petitioners' interpretation of what the EPA intended to do and petitioners' resulting theory of injury were too speculative. The panel further held that because petitioners' theory of injury was dependent upon harm caused by a failure to assess all conditions of use together, and because it was very uncertain whether EPA ever planned to do what petitioners feared, petitioners' alleged injury was too speculative at this time to establish Article III jurisdiction.

         Petitioners also argued that the Risk Evaluation Rule expressed an impermissible intent to exclude some conditions of use from the scope of a risk evaluation, thereby contravening TSCA's requirement that EPA consider all of a chemical's conditions of use. With respect to petitioners' challenge to language in the preamble to the Risk Evaluation Rule, the panel held that it was not final agency action, and thus not reviewable under the Administrative Procedure Act. With respect to petitioners' challenges to specific provisions of the Risk Evaluation Rule, the panel held that the challenges were justiciable final agency action. The panel further held that petitioners had standing to challenge these provisions, and that the challenge was ripe. The panel concluded that petitioners' claim failed on the merits because the challenged provisions did not in fact assert discretion to exclude conditions of use from evaluation.

         Finally, petitioners challenged EPA's categorical exclusion of legacy activities from the definition of "conditions of use." The panel held that this claim was justiciable. Turning to the merits, the panel held that EPA's exclusion of legacy uses and associated disposals contradicted TSCA's plain language, but that EPA's exclusion of legacy disposals did not.

          OPINION

          FRIEDLAND, CIRCUIT JUDGE.

         Petitioners, a variety of environmental groups and other organizations, seek review of a rule promulgated by the United States Environmental Protection Agency ("EPA" or "the Agency") establishing a process to evaluate the health and environmental risks of chemical substances. EPA promulgated the "Risk Evaluation Rule" under its authority granted by 15 U.S.C. § 2605(b)(4)(B), a provision added in 2016 to the Toxic Substances Control Act ("TSCA"), 15 U.S.C. § 2601 et seq.[1] Petitioners argue that provisions in the Risk Evaluation Rule relating to the Agency's evaluation of the risks from a substance's "conditions of use" violate several of TSCA's requirements. Specifically, Petitioners argue: (1) that TSCA requires EPA to evaluate risks associated with a chemical's uses collectively before determining that the chemical is safe; (2) that EPA must consider all of a chemical's conditions of use in that evaluation; and (3) that, when considering conditions of use, EPA must evaluate past disposals of all chemicals, as well as the use and subsequent disposal of chemicals not currently or prospectively manufactured or distributed in commerce for that use. Petitioners argue that various provisions of the Risk Evaluation Rule demonstrate that EPA will not do any of these three things.[2]

         We hold that we lack jurisdiction to review Petitioners' first challenge, and that their second fails on the merits. But we grant in part the Petition for Review with respect to Petitioners' third challenge.[3]

         I.

         A.

         Congress enacted TSCA in 1976 "to prevent unreasonable risks of injury to health or the environment associated with the manufacture, processing, distribution in commerce, use, or disposal of chemical substances." S. Rep. No. 94-698, at 1 (1976), as reprinted in 1976 U.S.C.C.A.N. 4491, 4491. TSCA was "designed to fill a number of regulatory gaps" in premarket review, regulation of chemicals themselves (rather than regulation of discharges, emissions, ambient air, or consumer products), and information-gathering responsibility. Id. at 1-2. TSCA required EPA to regulate chemical substances that the Agency found to "present an unreasonable risk of injury to health or the environment." 15 U.S.C. § 2605(a) (1976). As originally enacted, however, TSCA did not provide a specific process or timeline by which EPA was required to evaluate a substance's risks.

         In the decades following TSCA's passage, Congress found that "effective implementation of TSCA by [EPA] ha[d] been challenged by shortcomings in the statute itself, and by several key decisions of Federal Courts and the Agency's interpretation of those decisions." S. Rep. No. 114-67, at 2 (2015). There had "been persistent concerns about the pace of EPA's work under TSCA, the ability of the Agency to use its existing authority, and whether the statute prevent[ed] certain regulatory efforts." H.R. Rep. No. 114-176, at 12-13 (2015), as reprinted in 2016 U.S.C.C.A.N. 276, 277. Congress accordingly amended TSCA in 2016. See Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, 130 Stat. 448 (2016) (codified at 15 U.S.C. § 2601 et seq.); see also generally S. Rep. No. 114-67; H.R. Rep. No. 114-176.

         The 2016 amendments "restructur[ed] the way . . . chemicals are evaluated and regulated," H.R. Rep. No. 114-176, at 13, but Congress's policy goals reflected in the 1976 Act remained "intact," S. Rep. No. 114-67, at 7. Congress intended through the amendments "to provide broad protection of human health and the environment," and "to improve availability of information about chemicals." S. Rep. No. 114-67, at 6.

         B.

         The 2016 amendments create, among other things, "a separate risk evaluation process for determining whether a chemical substance presents or will present an unreasonable risk of injury," and prescribe statutory deadlines by which EPA is required to complete such evaluations. H.R. Rep. No. 114-176, at 23, 25. The amendments also direct EPA's Administrator to prioritize evaluations of the risks of chemicals considered to be the most dangerous. And once EPA determines that a particular chemical substance is associated with an unreasonable risk, the Agency is required to regulate that substance.

         With respect to prioritizing risk evaluations, TSCA requires that the Administrator "designate as a high-priority substance a chemical substance that the Administrator concludes . . . may present an unreasonable risk of injury to health or the environment . . . under the conditions of use." 15 U.S.C. § 2605(b)(1)(B)(i). The Administrator must designate a substance as "low-priority" if "such substance does not meet the standard" to be high-priority. 15 U.S.C. § 2605(b)(1)(B)(ii).

         For chemical substances that EPA designates as high-priority, the Agency must initiate and complete a risk evaluation of the chemical within three years, with a possible six-month extension. 15 U.S.C. § 2605(b)(3)(A), (b)(4)(G). EPA must also conduct some risk evaluations at the request of chemical manufacturers ("manufacturer-requested risk evaluations"). See 15 U.S.C. § 2605(b)(4)(C)(ii).

         TSCA's risk evaluation provision requires EPA to evaluate chemical substances under their "conditions of use." Specifically, TSCA states:

The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.

15 U.S.C. § 2605(b)(4)(A).

         The term "conditions of use" is defined to mean "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." 15 U.S.C. § 2602(4).[4] In the early stages of the risk evaluation process, TSCA requires EPA to list in a published scope document the conditions of use it "expects to consider" for the chemical substance being evaluated. 15 U.S.C. § 2605(b)(4)(D).

         Once a risk evaluation is completed, if the Administrator determines based on that evaluation "that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall" promulgate rules regulating that chemical substance so that it "no longer presents such [an unreasonable] risk." 15 U.S.C. § 2605(a); see also 15 U.S.C. § 2605(c)(1).

         In order to effectuate TSCA's statutory requirements, Congress instructed EPA to "establish, by rule, a risk-based screening process, including criteria for designating chemical substances as" either high-priority or low-priority for risk evaluation. 15 U.S.C. § 2605(b)(1)(A). EPA was also required to establish by rule "a process to conduct risk evaluations." 15 U.S.C. § 2605(b)(4)(B).

         TSCA also contains a judicial review provision. See 15 U.S.C. § 2618. It provides that "not later than 60 days after the date on which a rule is promulgated . . . or the date on which an order is issued [under TSCA] any person may file a petition for judicial review of such rule or order." 15 U.S.C. § 2618(a)(1)(A). TSCA specifically authorizes judicial review of EPA's determination that a substance is low-priority or poses no unreasonable risk. 15 U.S.C. § 2618(a)(1)(A), (a)(1)(C)(i).

         C.

         In accordance with TSCA, EPA issued rules for prioritization and risk evaluation in July 2017. The Risk Evaluation Rule states, generally, that EPA will evaluate chemical substances under their conditions of use:

As part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of uses [sic] within the scope of the risk evaluation, either in a single decision document or in multiple decision documents.

40 C.F.R. § 702.47.

         The Risk Evaluation Rule similarly explains that "[t]he scope of the risk evaluation will include," among other things, "[t]he condition(s) of use, as determined by the Administrator, that the EPA plans to consider in the risk evaluation." 40 C.F.R. § 702.41(c). "Conditions of use" is defined in the Risk Evaluation Rule as "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of"-the same definition as in TSCA itself. Compare 40 C.F.R. § 702.33, with 15 U.S.C. § 2602(4).

         In the preamble to the Risk Evaluation Rule, EPA states that three categories of uses and activities are excluded from the definition of conditions of use. Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 82 Fed. Reg. 33, 726, 33, 729 (July 20, 2017). These are: (1) "circumstances associated with activities that do not reflect ongoing or prospective manufacturing, processing, or distribution," which the Agency calls "legacy uses"; (2) "disposals from such uses," which the Agency calls "associated disposal"; and (3) "disposals that have already occurred," which the Agency calls "legacy disposal." Id. In this litigation, EPA refers to these uses and activities collectively as "legacy activities."

         EPA also states, in the preamble to the Risk Evaluation Rule, that it "intends to exercise discretion in addressing circumstances where [a] chemical substance . . . is unintentionally present as an impurity in another chemical substance that is not the subject of the pertinent scoping." 82 Fed. Reg. at 33, 730. In some circumstances, EPA states, "it may be most appropriate . . . to evaluate the potential risks arising from a chemical impurity within the scope of the risk evaluations for the impurity itself," while in others it "may be more appropriate to evaluate such risks within the scope of the risk evaluation for the separate chemical substances that bear the impurity." Id. The preamble further provides that the Agency "may choose not to include [that] impurity within the Scope of any risk evaluation," where "the risk from the presence of the impurity would be 'de minimis' or otherwise insignificant." Id. The preamble also lists several other uses that commenters had suggested should not be considered ...


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