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.
We hold that we lack jurisdiction to review Petitioners' first challenge, and that their second fails on the merits. But we
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 As originally enacted, however, TSCA did not provide a specific process or timeline by which EPA was required to evaluate a substance's risks.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.
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. 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:
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).
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).
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:
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 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.
Several groups filed petitions for review of the Risk Evaluation Rule pursuant to the judicial review provisions of TSCA, 15 U.S.C. § 2618, and the Administrative Procedure Act, 5 U.S.C. § 706. Those petitions were consolidated.
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."
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 40 C.F.R. § 702.47. Second is the Rule's statement that:
40 C.F.R. § 702.41(a)(9).
Finally, Petitioners challenge a provision of the Rule entitled "Final determination of no unreasonable risk," which states:
40 C.F.R. § 702.49(d).
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 15 U.S.C. § 2605(a). Petitioners contend that the Risk Evaluation Rule goes one step further, however, allowing EPA to issue a final determination that a chemical substance does not pose an unreasonable risk after having looked at only one or a few of its conditions of use. Petitioners argue that, under TSCA, the Agency may only issue a "no unreasonable risk" determination for a chemical substance after it has considered the risks associated with all of that substance's conditions of use.
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.
"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, ___ U.S. ___, 136 S.Ct. 1540, 1547, 194 L.Ed.2d 635 (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
Ohio Forestry Ass'n, Inc. v. Sierra Club, 523 U.S. 726, 732-33, 118 S.Ct. 1665, 140 L.Ed.2d 921 (1998) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 148-49, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), abrogated on other grounds by Califano v. Sanders, 430 U.S. 99, 105, 97 S.Ct. 980, 51 L.Ed.2d 192 (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.
Although a judicial review provision like that in 15 U.S.C. § 2618 avoids any prudential ripeness concerns about claims brought under that provision, such a provision does not make a claim constitutionally ripe. The Supreme Court emphasized in Spokeo that Congress cannot confer Article III jurisdiction when it is otherwise lacking. See Spokeo, 136 S. Ct. at 1547-48 ("Injury in fact is a constitutional requirement, and `[i]t is settled that Congress cannot erase Article III's standing requirements by statutorily granting the right to sue to a plaintiff who would not otherwise have standing.'" (alteration in original) (quoting Raines v. Byrd, 521 U.S. 811, 820 n.3, 117 S.Ct. 2312, 138 L.Ed.2d 849 (1997))). And while Spokeo itself addressed Article III standing, the same is necessarily true of Article III ripeness, which is also a constitutional requirement. See Stolt-Nielsen S.A. v. Animal-Feeds Int'l Corp., 559 U.S. 662, 670 n.2, 130 S.Ct. 1758, 176 L.Ed.2d 605 (2010) ("Ripeness reflects constitutional considerations that implicate `Article III limitations on judicial power.'" (quoting Reno v. Catholic Soc. Servs., Inc., 509 U.S. 43, 57 n.18, 113 S.Ct. 2485, 125 L.Ed.2d 38 (1993))); cf. Barenblatt v. United States, 360 U.S. 109, 112, 79 S.Ct. 1081, 3 L.Ed.2d 1115 (1959) ("Congress ... must exercise its powers subject to the limitations placed by the Constitution on governmental action."). Petitioners must therefore establish that their case is justiciable under the Article III doctrines of standing and ripeness, with respect to each of their claims.
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.
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.
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." 40 C.F.R. § 702.47 (emphasis added). One reading of this provision (and its use of the term "each") does suggest that EPA will evaluate risks associated with conditions of use individually. But it does not necessarily mean that EPA will (or even could) make determinations of "no unreasonable risk" based only on individual use-by-use evaluations, rather than on an evaluation that looks at "each" condition —as in "every one of the" conditions —of use together.
The same is true of the statement in 40 C.F.R. § 702.41(a)(9) that Petitioners challenge, which provides that "EPA will complete the risk evaluation of the chemical substance addressing all of the conditions of use within the scope of the evaluation." This could well mean EPA will do exactly what Petitioners argue it must: consider all conditions of use before completing a risk determination for a chemical. It also states that "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." 40 C.F.R. § 702.41(a)(9). But again, although this suggests that EPA plans to conduct some use-by-use risk determinations, it does not clearly mean that EPA will fail to do what Petitioners argue is required under TSCA.
The last provision that Petitioners challenge, 40 C.F.R. § 702.49(d), is no different. There, the Rule states merely that "[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 ... will be issued by order and considered to be a final Agency action." 40 C.F.R. § 702.49(d). We simply do not know what this provision means either, or how the Agency will apply it in any particular case.
Other provisions in the Rule are similarly ambiguous. One states:
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).
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, 134 S.Ct. 2334, 189 L.Ed.2d 246 (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,
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, 113 S.Ct. 2485 (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, 113 S.Ct. 2485 (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, 118 S.Ct. 2091, 141 L.Ed.2d 393 (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 15 U.S.C. §§ 2618(a)(1)(A), 2605(i)(1).
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 40 C.F.R. § 702.41(c). Petitioners also point to EPA's references in the Risk Evaluation Rule to the conditions of use "within the scope of" the evaluation, see 40 C.F.R. §§ 702.41(a)(5), (a)(8), (a)(9), (c)(4)(i), (c)(4)(iii), (d)(2); 702.49(b)-(d), arguing that this wording further shows that EPA does not intend to consider all conditions of use. Petitioners express similar concern about the provision on manufacturer-requested risk evaluations:
40 C.F.R. § 702.37(e)(3). Petitioners argue that these provisions demonstrate that not all conditions of use will be in the scope of a risk evaluation, and that EPA is asserting discretion to exclude some conditions of use.
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.
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.
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 TSCA requires EPA to consider all conditions of use within the scope of a chemical substance's risk evaluation, the provisions of the Risk Evaluation Rule that Petitioners challenge do not evince any contrary intent on the part of EPA.
Looking first at Petitioners' standing to challenge the scope provisions of the Risk Evaluation Rule, Petitioners argue that they will imminently be harmed by EPA's exclusion of some conditions of use from consideration, because EPA will systematically understate risks associated with chemicals that are evaluated. Petitioners also argue that because (on their reading) the Risk Evaluation Rule allows EPA to avoid evaluating some potential risks associated with chemical substances, the Rule excludes necessary information from EPA's publications.
As an initial matter, the challenged language here is not ambiguous, so it is not speculative whether the Rule authorizes EPA to do what Petitioners claim. This differentiates it from Petitioners' challenge to use-by-use determinations which, as we explained above, is too speculative to evaluate. Moreover, to the extent Petitioners are correct both that the Risk Evaluation Rule asserts the Agency's discretion to exclude conditions of use and that TSCA forecloses the Agency from asserting such discretion, their alleged injuries would be caused by the challenged provisions. See Nat. Res. Def. Council v. EPA, 643 F.3d 311, 319-23 (D.C. Cir. 2011). Although, as we explain, we do not agree with Petitioners that the Rule provisions actually have the effect that Petitioners claim, this distinction
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 TSCA itself referring to the conditions of use that the Administrator "expects to consider" does not grant EPA discretion to exclude conditions of use. See 15 U.S.C. § 2605(b)(4)(D). We see no reason why "plans to consider" should be read differently than "expects to consider."
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 40 C.F.R. § 702.37(e)(3). But a more natural reading is that this refers, again, simply to the Agency's discretion (and expertise) in determining what constitutes a condition of use for a particular chemical substance. We therefore conclude that the challenged provisions unambiguously do not grant EPA the discretion Petitioners contend. See Encino Motorcars, LLC v. Navarro, ___ U.S. ___, 138 S.Ct. 1134, 1143, 200 L.Ed.2d 433 (2018) (resolving a question of statutory interpretation based on "the best reading of the statute"); Nat'l Cable & Telecomms. Ass'n v. Gulf Power Co., 534 U.S. 327, 333, 122 S.Ct. 782, 151 L.Ed.2d 794 (2002) ("This is our own, best reading of the statute, which we find unambiguous.").
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 EPA's approach to that evaluation is evidence that the Risk Evaluation Rule has the effect they fear.
We therefore conclude that Petitioners' challenge relating to excluding conditions of use from the scope of risk evaluations fails.
Finally, we turn to Petitioners' challenge to EPA's categorical exclusion of legacy activities from the definition of "conditions of use."
TSCA defines the term "conditions of use" 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). The definition in the Risk Evaluation Rule parrots the statute. See 40 C.F.R. § 702.33. In the preamble to the Risk Evaluation Rule, EPA elaborated on this definition, however, and stated that it does not consider what it now calls "legacy activities"—consisting of "legacy uses," "associated disposals," and "legacy disposals" —to be conditions of use. See 82 Fed. Reg. at 33,729-30.
EPA defines the term "legacy uses" in the preamble as "the circumstances associated with activities that do not reflect ongoing or prospective manufacturing, processing, or distribution." Id. at 33,729. For
Again addressing jurisdiction first, we agree with both Petitioners and EPA that this claim is justiciable. Proceeding to the merits, we hold that EPA's exclusion of legacy uses and associated disposals contradicts TSCA's plain language, but that EPA's exclusion of legacy disposals does not.
Petitioners argue that their challenge to EPA's exclusion of each of the three types of legacy activities is justiciable. They contend that it is sufficiently clear that EPA has categorically excluded legacy activities from consideration as conditions of use, and that they will be harmed by these exclusions. As to this claim, EPA agrees with Petitioners that we have jurisdiction —conceding that Petitioners' allegation that they will be harmed by risk determinations that do not include legacy activities "is a sufficient allegation for standing purposes," and that the challenge is ripe because "EPA created a general presumption that it will not prioritize and evaluate existing chemicals under their legacy uses and disposals." We agree.
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, EPA's interpretation here is "definitional," and generally "requir[es] EPA to ignore ongoing exposures from `legacy activities' in every risk evaluation." Petitioners claim that excluding these ongoing exposures from consideration will understate a chemical's health risks, violating Petitioners' right to risk evaluations that comply with TSCA.
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, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984).
As an initial matter, we note that although EPA's exclusion of legacy activities appears in the preamble to the Risk Evaluation Rule rather than in the text of the rule itself, EPA concedes that its "preamble interpretation regarding legacy activities is reviewable because it is a binding statutory interpretation that EPA stated it intends to apply going forward." We agree. EPA definitively "resolve[d] the [asserted] statutory ambiguity" in the definition of "conditions of use" when it announced in the preamble that it would exclude legacy activities. 82 Fed. Reg. at 33,730. EPA specifically stated that it "interpret[ed] [TSCA's] mandates" to be inapplicable to legacy activities, and accordingly "interpret[ed] the definition" of "conditions of use." Id. This interpretation was EPA's final, unequivocal interpretation —there is every reason to believe that the Agency intended to bind itself, and what is required by this interpretation is, as EPA concedes, sufficiently clear to be reviewable.
TSCA defines "conditions of use" as "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably
In defending its interpretation here, EPA draws on these explanations given in the preamble. EPA further argues that the terms "intended" and "reasonably foreseen" as used in TSCA's definition of "conditions of use" "are plainly forward looking"; that "known," when combined with "to be," is a "present tense verb"; and that "intended," "known," and "reasonably foreseen" are all "broad, general terms that plainly require EPA to exercise its judgment." This language, EPA contends, demonstrates that Congress intended EPA to focus on activities for which the manufacturing, processing, or distribution in commerce of a chemical is intended, known, or reasonably foreseen. EPA also argues that it would make little sense to interpret conditions of use to include activities that EPA has little time to evaluate or ability to regulate, and that TSCA should be interpreted to allow the Agency to focus on quickly regulating the worst risks, which it contends do not arise from legacy activities.
Petitioners argue that EPA's interpretation is contradicted by the plain text of TSCA's statutory definition of "conditions of use," and is not saved by any grant of unfettered discretion to the Agency. Petitioners argue that EPA's interpretation, which only includes the use and subsequent disposal of chemicals that also continue to be manufactured, processed, or distributed in commerce for that same use, fails to give independent meaning to "use" and "disposal" in the statutory definition's disjunctive list ("manufactured, processed, distributed in commerce, used, or disposed of"). For instance, Petitioners note, "lead pipes are `known to be used' in water distribution systems," and "[t]his is true regardless of whether lead pipes continue to be manufactured or distributed." Petitioners also argue that an interpretation that "would result in inconsistent treatment of identical activities based solely on whether manufacture or distribution is ongoing," as EPA's would, does not square
EPA's contention that TSCA can reasonably be read to refer to the future use of a product, and disposals associated with such use, only when the product will also be manufactured in the future for that use—and not when the product is no longer manufactured for the relevant use—is without merit. TSCA's "conditions of use" definition plainly addresses conditions of use of chemical substances that will be used or disposed of in the future, regardless of whether the substances are still manufactured for the particular use.
Although we agree with EPA that the phrase "to be" in the statutory definition denotes the present or future tense, when "to be" is combined with "used" and "disposed of," two plain meanings result: future uses, and future disposals. And these are precisely the things that EPA has purported to exclude by defining conditions of use to exclude legacy uses and associated disposals: activities (i.e., uses), "that do not reflect ongoing or prospective manufacturing, processing, or distribution,"
The example used by EPA in the Risk Evaluation Rule's preamble—the disposal of insulation previously installed in a building —in fact serves as a useful example for why the Agency's interpretation cannot be upheld: The future disposal of asbestos insulation is clearly an example of a chemical substance being "disposed of." To the extent it is "intended" that such a substance be disposed of, or "known" that it will be, or if such disposal is "reasonably foreseen," that circumstance unambiguously falls within TSCA's definition of "conditions of use." Similarly, as Petitioners point out, if lead pipes exist in water distribution systems, they are "known to be used" in those systems. This is so without any regard to whether these substances are also intended, known, or reasonably foreseen to be prospectively manufactured (or processed, or distributed in commerce) for those uses. See 15 U.S.C. § 2602(4) (referring to substances that will be "manufactured,
EPA resists this conclusion, arguing that the Agency has broad discretion, granted to it by TSCA, to determine what constitutes a condition of use.
We draw a distinction, however, between "legacy uses" and "associated disposals," on the one hand, and "legacy disposals," on the other. EPA uses the term "legacy disposals" to refer to "disposals that have already occurred (e.g., a chemical substance currently in a landfill or in groundwater)." 82 Fed. Reg. at 33,729. As to this issue, EPA's present tense argument has more force, and we hold that its interpretation is permissible under TSCA.
In our view, TSCA unambiguously does not require past disposals to be considered conditions of use. The statutory definition, once again, covers the circumstances "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). A substance that has already been disposed of will not ordinarily be intended, known, or reasonably foreseen to
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 TSCA itself does not define the term "disposal," EPA has previously defined the term in the context of regulating chemicals known as PCBs, under the pre-2016 TSCA. In that context, EPA defines "disposal" to mean "intentionally or accidentally to discard, throw away, or otherwise complete or terminate the useful life of PCBs and PCB Items," and specifically notes that "[d]isposal includes spills, leaks, and other uncontrolled discharges of PCBs as well as actions related to containing, transporting, destroying, degrading, decontaminating, or confining PCBs and PCB Items." 40 C.F.R. § 761.3. EPA takes issue with Petitioners' reliance on this definition, but acknowledges in its briefing here that the term "disposed of" could refer to "the act of putting something in a landfill or other resting place, or it could conceivably refer to the movement of chemicals by natural forces after the initial act of disposal."
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 40 C.F.R. § 761.3—would not be considered independent disposals. They would thus qualify as "disposals" (and therefore conditions of use) for substances that are currently manufactured for their pre-disposal use, or "associated disposals" for substances that are no longer manufactured for their pre-disposal use. If, under the applicable definition of "disposal," something is in fact again disposed of—even if it was disposed of previously—or when a disposal is in fact ongoing, we see no reason why that use is not captured as a prospective disposal. But that does not mean that legacy disposals—as used to refer simply to "disposals that have already occurred"—should fall under the statutory definition of "conditions of use."
Because TSCA's statutory definition of "conditions of use" unambiguously does not reach legacy disposals, we hold that the Agency did not err in excluding such disposals from consideration as "conditions of use." See Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778 ("If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.").
For the reasons discussed, the Petition for Review is