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.
No. 17-72260
United States Court of Appeals, Ninth Circuit
November 14, 2019
Argued and Submitted May 16, 2019, Seattle, Washington. Andrew Wheeler has been substituted for his predecessor, Scott Pruitt, under Fed. R. App. P. 43(c)(2).
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.
No. 17-72501
United States Court of Appeals, Ninth Circuit
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.
No. 17-72968
United States Court of Appeals, Ninth Circuit
EPA No. EPA-HQ-OPPT-2016-0636
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.
No. 17-73290
United States Court of Appeals, Ninth Circuit
EPA No. EPA-HQ-OPPT-2016-0654
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.
No. 17-73383
United States Court of Appeals, Ninth Circuit
EPA No. EPA-HQ-OPPT-2016-0654
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.
No. 17-73390
United States Court of Appeals, Ninth Circuit
EPA No. EPA-HQ-OPPT-2016-0654
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.
COUNSEL
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
James W. Conrad, Jr., Conrad Law & Policy Counsel, Washington, D.C.; for Respondent-Intervenor
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.
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
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
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.”
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
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
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.
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.
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.”
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.”
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.
TSCA also contains a judicial review provision. See
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.
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.”
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 disposals.”
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 in risk evaluations, such as misuse and illegal use. Id. The preamble ultimately concludes, however, that “it would be premature to definitively exclude a priori specific conditions of use from risk evaluation.” Id.
D.
Several groups filed petitions for review of the Risk Evaluation Rule pursuant to the judicial review provisions of TSCA,
Petitioners argue that TSCA requires EPA to evaluate risks from uses of a chemical substance collectively, and that the Risk Evaluation Rule contradicts this mandate. Separately, Petitioners argue that the Risk Evaluation Rule expresses an impermissible intent to exclude some conditions of use from the scope of a risk evaluation. Finally, Petitioners challenge EPA’s exclusion of legacy activities from the definition of “conditions of use.”
II.
A.
Petitioners first challenge provisions of the Risk Evaluation Rule relating to the process by which EPA will conduct risk determinations. Petitioners argue that several provisions in the Rule assert that EPA has authority to determine whether individual conditions of use, in isolation, pose unreasonable risks, rather than to evaluate the risks posed by a chemical substance holistically. Specifically, Petitioners challenge three provisions of the Rule. First is EPA’s statement that it “will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of use[] within the scope of the risk evaluation, either in a single decision document or in multiple decision documents.” See
EPA will complete the risk evaluation of the chemical substance addressing all of the conditions of use within the scope of the evaluation. However, EPA may complete its evaluation of the chemical substance under specific conditions of use or categories of conditions of use at any point following the issuance of the final scope document, and issue its determination as to whether the chemical substance under those conditions of use does or does not present an unreasonable risk to health or the environment under those conditions of use.
Finally, Petitioners challenge a provision of the Rule entitled “Final determination of no unreasonable risk,” which states:
A determination by EPA that the chemical substance, under one or more of the conditions of use within the scope of the risk evaluation, does not present an unreasonable risk of injury to health or the environment will be issued by order and considered to be a final Agency action.
Petitioners interpret these provisions to mean that EPA plans to conduct use-by-use
Petitioners recognize that when EPA decides that a particular condition of use does pose an unreasonable risk, such a determination on its own complies with TSCA’s requirement that EPA conduct an evaluation of whether “the substance as a whole poses unreasonable risk.” That is because, as Petitioners explain, if any condition of use (or any combination of subsets of the conditions of use) associated with a chemical poses an unreasonable risk of harm, that chemical substance would necessarily pose an unreasonable risk under all of its conditions of use considered together. As soon as the Agency determines that any combination of conditions of use pose such a risk, therefore, the Agency may proceed to regulate that chemical under
We hold that this challenge is not justiciable because Petitioners’ interpretation of what EPA intends to do and Petitioners’ resulting theory of injury are too speculative.
1.
“Article III of the Constitution empowers us to adjudicate only ‘live cases or controversies,’ not ‘to issue advisory opinions [or] to declare rights in hypothetical cases.’” Clark v. City of Seattle, 899 F.3d 802, 808 (9th Cir. 2018) (quoting Thomas v. Anchorage Equal Rights Comm‘n, 220 F.3d 1134, 1138 (9th Cir. 2000) (en banc)). The requirement of Article III standing “aids the federal judiciary to avoid intruding impermissibly upon the powers vested in the executive and legislative branches, by preventing courts from issuing advisory opinions not founded upon the facts of a controversy between truly adverse parties.” Scott v. Pasadena Unified Sch. Dist., 306 F.3d 646, 654 (9th Cir. 2002). For purposes of standing, a plaintiff must establish he or she has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).
An “injury in fact” is “an invasion of a legally protected interest which is
“Ripeness is [another] . . . doctrine[] that we use to determine whether a case presents a live case or controversy” over which we have jurisdiction under Article III. Clark, 899 F.3d at 808. Ripeness doctrine
is designed “to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect . . . agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties.”
Ohio Forestry Ass’n, Inc. v. Sierra Club, 523 U.S. 726, 732–33 (1998) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 148–49 (1967), abrogated on other grounds by Califano v.Sanders, 430 U.S. 99, 105 (1977)). Because ripeness doctrine derived “both from Article III limitations on judicial power and from prudential reasons for refusing to exercise jurisdiction,” Clark, 899 F.3d at 809 (quoting Thomas, 220 F.3d at 1138), the “ripeness inquiry” has often involved “both ‘a constitutional and a prudential component,’” id. (quoting Bishop Paiute Tribe v. Inyo County, 863 F.3d 1144, 1153 (9th Cir. 2017)).
To satisfy the constitutional ripeness requirement, a case “must present issues that are definite and concrete, not hypothetical or abstract.” Id. (quoting Bishop Paiute Tribe, 863 F.3d at 1153). “[S]orting out where standing ends and ripeness begins is not an easy task,” id. (quoting Thomas, 220 F.3d at 1138), so “[c]onstitutional ripeness is often treated under the rubric of standing because ripeness coincides squarely with standing’s injury in fact prong,” id. (alteration in original) (quoting Bishop Paiute Tribe, 863 F.3d at 1153).
Where (as here) there is a judicial review provision in a statute, any prudential ripeness considerations are satisfied for cases brought under that provision.8 See Ohio Forestry Ass’n, 523 U.S. at 737 (citing TSCA’s judicial review provision in
Although a judicial review provision like that in
2.
a.
Petitioners argue that they are injured by the use-by-use approach of the Risk Evaluation Rule in two ways. First, Petitioners contend, the use-by-use approach will lead EPA to underestimate risk where exposure results from multiple activities involving a chemical, which threatens their concrete interests in avoiding harmful exposures to chemicals. Second, they argue that the Rule will deprive them of information about chemical risks to which they are entitled under TSCA and that they need to reduce exposures to toxic chemicals.9 Petitioners maintain that these injuries are imminent, noting, for example, that their members are currently exposed to a chemical flame retardant that is already undergoing risk evaluation. They also argue that their claims are ripe, pointing to TSCA’s judicial review provision and the harm
EPA argues that Petitioners’ claim is nonjusticiable because it is based merely on a “hypothes[i]s about how EPA may apply [the Rule] in the future,” and therefore Petitioners have not alleged “a concrete or particularized injury.” EPA maintains that if it ever does take final agency action that Petitioners believe fails to comply with TSCA’s requirements, then Petitioners could challenge that action. Intervenors agree with EPA that this claim is not justiciable, because the existence of the Risk Evaluation Rule itself could not possibly cause Petitioners any injury.
b.
We conclude that Petitioners’ challenge regarding use-by-use risk evaluations is not justiciable because it is not clear, due to the ambiguous text of the Risk Evaluation Rule, whether the Agency will actually conduct risk evaluations in the manner Petitioners fear.
Petitioners rely heavily on the Rule’s reference to “whether [a] chemical substance presents an unreasonable risk of injury to health or the environment under each condition of use[] within the scope of the risk evaluation.”
The same is true of the statement in
The last provision that Petitioners challenge,
Other provisions in the Rule are similarly ambiguous. One states:
In general, EPA intends to determine whether a chemical substance does or does not present an unreasonable risk under all of the conditions of use within the scope of the risk evaluations, and intends to identify the individual conditions of use or categories of conditions of use that are responsible for such determinations.
And, in fact, the preamble to the Risk Evaluation Rule weighs against Petitioners’ understanding of EPA’s plans, as it supports the notion that EPA will evaluate risks collectively, just as Petitioners wish: “[T]he Agency is to exercise [its] discretion consistent with the objective of conducting a technically sound, manageable evaluation to determine whether a chemical substance—not just individual uses or activities—presents an unreasonable risk.” Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 82 Fed. Reg. 33,726, 33,729 (July 20, 2017).10
The lack of clarity in what the regulations promulgated by EPA mean creates a justiciability problem with Petitioners’ claim. To the extent it is not clear how EPA will actually conduct risk evaluations under these rules, there is no concrete, imminent harm to Petitioners’ interests that is caused by the challenged provisions. On this point we look to two analogous contexts: pre-enforcement challenges to rules that proscribe certain behavior, and challenges to rules that confer benefits on individuals.
In the context of pre-enforcement challenges to agency rules governing the behavior of regulated parties, we have recognized that “[n]either the ‘mere existence of a proscriptive statute’ nor a ‘generalized threat of prosecution’ satisfies the ‘case or controversy’ requirement.” Wolfson v. Brammer, 616 F.3d 1045, 1058 (9th Cir. 2010) (quoting Thomas, 220 F.3d at 1139). Rather, “for a claim to be ripe, the plaintiff must be subject to a genuine threat of imminent prosecution.” Id. (quotation marks and emphasis omitted). In evaluating the existence of any such genuine threat, we look at three criteria: “(1) whether the plaintiff has articulated a concrete plan to violate the law in question; (2) whether the prosecuting authorities have communicated a specific warning or threat to initiate proceedings; and (3) the history of past prosecution or enforcement under the challenged statute.” Id.; see also Susan B. Anthony List v. Driehaus, 573 U.S. 149, 159 (2014) (“[W]e have held that a plaintiff satisfies the injury-in-fact requirement where he alleges ‘an intention to engage in a course of conduct arguably affected with a constitutional interest, but proscribed by a statute, and there exists a credible threat of prosecution thereunder.’” (quoting Babbitt v. United Farm Workers Nat’l Union, 442 U.S. 289, 298 (1979))).
In the context of “benefit-conferring rule[s],” Mont. Envtl. Info. Ctr. v. Stone-Manning, 766 F.3d 1184, 1190 (9th Cir. 2014) (quoting Reno, 509 U.S. at 69 (O’Connor, J., concurring in the judgment)), we have applied a “firm prediction rule” to determine constitutional ripeness, id. Under that rule, drawn from Justice O’Connor’s concurring opinion in Reno v. Catholic Social Services, Inc. and adopted by our court in Freedom to Travel Campaign v. Newcomb, 82 F.3d 1431 (9th Cir. 1996), we ask whether we “can make a firm prediction that the plaintiff will apply for the benefit [at issue], and that the agency will deny the application by virtue of the [challenged] rule.” Id. at 1436 (quoting Reno, 509 U.S. at 69 (O’Connor, J., concurring in the judgment)).
While neither of these lines of cases speaks directly to the issue that we now face, both clearly aim to deduce, in different contexts, the extent to which a claimed injury is actually and non-speculatively impending. Applying the principles underlying each of these tests, we conclude that Petitioners’ challenge regarding use-by-use determinations is not justiciable. Because of the ambiguity in the rules, we cannot predict whether Petitioners will be harmed in the way they claim, or whether the Agency will in fact apply these rules as Petitioners wish.
Clark v. City of Seattle is also instructive in this regard. In Clark, Seattle’s city council passed an ordinance establishing a multistep collective bargaining process applicable to ride-hailing services. A group of drivers sued, challenging the legality of the ordinance, and we held that the challenge was not ripe under Article III. 899 F.3d at 809 n.4. Among other things, we noted that injury to the drivers was not actual or imminent, because it would occur only if a contract or agreement was in fact reached—and no such contract or agreement was near. Id. at 810–11. The assertion of injury was therefore “wholly speculative.” Id. at 811. Petitioners’ theory of injury in this case is even more speculative. In Clark, it was clear what the procedures would be but unclear whether they would actually be invoked. Here, it is not even clear what EPA’s procedures will be, let alone whether EPA will employ them in a way that injures Petitioners.
Because Petitioners’ theory of injury is dependent upon harm caused by a failure to assess all conditions of use together, and because it is very uncertain whether EPA ever plans to do what Petitioners fear, Petitioners’ alleged injury is too speculative at this time to establish Article III jurisdiction. See Clinton v. City of New York, 524 U.S. 417, 432 (1998) (emphasizing that plaintiffs must establish a “sufficient likelihood of . . . injury to establish standing”). If EPA does, in the future, fail to consider all conditions of use together in completing a risk evaluation, and if Petitioners are harmed by that failure, then Petitioners may, under TSCA, seek review of EPA’s “no unreasonable risk” determination. See
B.
Petitioners next argue that the Risk Evaluation Rule contravenes TSCA’s requirement that EPA consider all of a chemical’s conditions of use when conducting a risk evaluation—which Petitioners assert is required whether or not Petitioners are correct in their argument, discussed above, that the risk analysis should look at uses collectively. Petitioners’ challenge relating to the proper scope of a risk evaluation comes in two forms: a challenge to preambular language, and challenges to provisions of the Risk Evaluation Rule (which we will refer to as the “scope provisions”).
First, Petitioners identify language in the preamble to the Risk Evaluation Rule that they contend reflects EPA’s intent not to consider every condition of use. For example, Petitioners direct our attention to EPA’s suggestion that it may exclude circumstances in which a substance is unintentionally present as an impurity in a second chemical from the risk evaluation of the substance present as the impurity, and may instead evaluate the risks associated with the impurity in the context of the second chemical. See 82 Fed. Reg. at 33,730. Petitioners also point to EPA’s suggestion that it may disregard the existence of that impurity entirely if its associated risk would be de minimis. Id.
Second, Petitioners challenge several provisions of the Risk Evaluation Rule itself, relying to some extent on the preamble to support these claims. Specifically, Petitioners challenge the Risk Evaluation Rule’s statement that “[t]he scope of the risk evaluation will include . . . [t]he condition(s) of use, as determined by the Administrator, that the EPA plans to consider in the risk evaluation.” See
EPA will assess whether the circumstances identified in the request constitute condition [sic] of use under [the Risk Evaluation Rule’s definition section], and whether those conditions of use warrant inclusion within the scope of a risk evaluation for the chemical substance. EPA will also assess what, if any, additional conditions of use that [sic] warrant inclusion within the scope of a risk evaluation for the chemical substance.
With respect to the challenged preambular language, we hold that it is not final agency action, and thus is not reviewable under the Administrative Procedure Act. We are left, then, with Petitioners’ challenges to specific provisions of the Risk Evaluation Rule. Although we conclude that these challenges are justiciable, we hold that they fail on the merits because the provisions that Petitioners point to do not, as Petitioners contend, in fact assert discretion to exclude conditions of use from evaluation.
1.
The Administrative Procedure Act gives courts the authority to review
In the preamble to the Risk Evaluation Rule, the Agency noted that based on its reading of TSCA, it “may, on a case-by-case basis, exclude certain activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are likely to present the greatest concern.” 82 Fed. Reg. at 33,729. The Agency indicated that it may do so when a risk associated with a use would be de minimis, or when another regulatory agency has already assessed that use. Id.
In a section of the preamble entitled “Conditions of use that may be excluded from the [s]cope of the risk evaluation,” id. at 33,730, EPA “elaborate[d] further on this,” id. at 33,729. There, EPA explained 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.” Id. at 33,730. In some circumstances, EPA stated, “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 Agency further provided that it “may choose not to include [that] impurity within the [s]cope of any risk evaluation,” where “the risk from the presence of the impurity would be ‘de minimis’ or otherwise insignificant.” Id. EPA also listed several other uses that commenters had suggested should not be considered in risk evaluations, including: “[u]ses where other agencies hold jurisdiction, misuse, illegal use, speculative future conditions of use, [or] uses that are inconsistent with labeling requirements.” Id. EPA ultimately concluded, however, that “it would be premature to definitively exclude
This is not the sort of language that indicates an agency has intended to bind itself—in fact, it appears to be just the opposite. The preambular language concerning the scope of risk evaluations indicates only that EPA could “exercise discretion” about the context in which it could evaluate a substance that is present as an impurity, and “may choose not to” ever consider the impurity when its risk would be de minimis. See id. (emphasis added); see also Nat. Res. Def. Council v. EPA, 559 F.3d 561, 565 (D.C. Cir. 2009) (emphasizing, in the context of evaluating finality, a distinction between “may” and “will”). The Agency referenced other uses that commenters had suggested should be excluded from the scope of a risk evaluation, but explicitly decided not to definitively exclude any “specific conditions of use,” explaining that it would make “reasonable, technically sound scoping decisions” with respect to each individual substance evaluated. 82 Fed. Reg. at 33,730. The preamble language does not bind the agency to ever exclude any conditions of use from consideration. It therefore is not reviewable as final agency action under the Administrative Procedure Act.
2.
We turn next to Petitioners’ challenge to the scope provisions. These provisions, as part of the Rule itself, clearly qualify as final agency action, see Cal. Sea Urchin Comm’n, 828 F.3d at 1049, and we conclude that Petitioners’ challenge to them is justiciable. Nonetheless, Petitioners’ challenge fails on the merits. Even assuming
a.
Looking first at Petitioners’ standing to challenge the scope provisions of the Risk Evaluation Rule, Petitioners argue that they will imminently be harmed by
As an initial matter, the challenged language here is not ambiguous, so it is not speculative whether the Rule authorizes
b.
Petitioners’ challenge to the Rule’s scope provisions, however, fails on the merits. The problem with Petitioners’ theory is that the meaning they attribute to these provisions is inconsistent with the provisions themselves. The phrase “the conditions of use within the scope of” an evaluation simply refers to the conditions of use that are applicable to any particular substance—and that therefore are included in the scope of that substance’s evaluation—without excluding any conditions of use in forming that list. Likewise, the phrase that refers to the conditions of use “that the EPA plans to consider” simply refers to the Agency’s role in determining what the conditions of use are for a particular substance. Petitioners effectively acknowledge as much in arguing that the similar language of
The provision on manufacturer-requested risk evaluations may lend some support to Petitioners’ contrary reading—at least to the extent it suggests that the question whether a circumstance constitutes a condition of use is separable from the question whether that condition of use “warrant[s] inclusion within” a risk evaluation’s scope. See
We recognize that to the extent a rule is ambiguous, its preamble—even if not itself reviewable as final agency action—may help explain the promulgating agency’s intent. See City of Las Vegas v. FAA, 570 F.3d 1109, 1117 (9th Cir. 2009) (“When a regulation is ambiguous, we consult the preamble of the final rule as evidence of context or intent of the agency promulgating the regulations.”); El Comite Para El Bienestar de Earlimart v. Warmerdam, 539 F.3d 1062, 1070 (9th Cir. 2008) (“[T]he preamble language should
Petitioners also point to the ongoing evaluation of the chemical substance 1,4-dioxane, which is a byproduct created in manufacturing processes and also appears as a contaminant in consumer products. Petitioners contend that
We therefore conclude that Petitioners’ challenge relating to excluding conditions of use from the scope of risk evaluations fails.
C.
Finally, we turn to Petitioners’ challenge to
Again addressing jurisdiction first, we agree with both Petitioners and
1.
Petitioners argue that their challenge to
Petitioners argue that their members are exposed to—and injured by—the use of chemical substances through legacy activities. For example, Petitioner United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union has members who, through their work, are exposed to the known carcinogen asbestos in the form of legacy uses when “equipment or structures are demolished, repaired[,] or refurbished.” Petitioners also argue that their members are at risk of exposure to asbestos through its associated disposal. Petitioners similarly claim that their members suffer harmful lead exposures resulting from the “legacy use” of lead paint and water pipes.
Petitioners have standing to challenge this exclusion, and their challenge is ripe. As Petitioners point out,
2.
In reviewing an agency’s interpretation of a statute, we apply the standard articulated by the Supreme Court in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).17 See Akhtar v. Burzynski, 384 F.3d 1193, 1198 (9th Cir. 2004). Under Chevron step one, we ask “whether Congress has directly spoken to the precise question at issue.” Id. At that point, “[i]f the intent of Congress is clear, that is the end of the matter; . . . [we] must give effect to the unambiguously expressed intent of Congress.” Id. (quoting Chevron, 467 U.S. at 842–43). But if “the statute is silent or ambiguous with respect to the specific issue, we must ask” at Chevron step two “whether the regulations promulgated by the agency are based on a permissible construction of the statute.” Id. If they are, we “must defer to the agency.” Id. We need not defer to agency regulations, however, “if they construe a statute in a way that is contrary to congressional intent or that frustrates congressional policy.” Id.
a.
As an initial matter, we note that although
b.
In defending its interpretation here,
Petitioners argue that
c.
Although we agree with
The example used by
d.
We draw a distinction, however, between “legacy uses” and “associated disposals,” on the one hand, and “legacy disposals,” on the other.
In our view,
Petitioners argue that “disposal” in this context “is not a one-time occurrence when the substance . . . is buried or placed in a landfill or other waste facility,” but rather that disposal “remains ongoing after the initial act of discard.” By way of example, Petitioners note that although
We need not wade into any debate over the precise meaning of “disposal.” Even accepting Petitioners’ asserted definition, we see no reason why “spills, leaks, and other uncontrolled discharges”—or even “actions related to containing . . . or confining” substances as also referenced in
Because
III.
For the reasons discussed, the Petition for Review is DISMISSED in part, GRANTED in part, and DENIED in part.25 The Petition is dismissed with respect to Petitioners’ challenge regarding use-by-use determinations. The Petition is