1 UNITED STATES COURT OF APPEALS 2 FOR THE SECOND CIRCUIT 3 4 August Term, 2020 5 6 (Argued: March 4, 2021 Decided: September 1, 2021) 7 8 Docket Nos. 19-1042(L); 19-1044; 19-2329 9 10 11 _____________________________________ 12 13 LABOR COUNCIL FOR LATIN AMERICAN ADVANCEMENT; NATURAL 14 RESOURCES DEFENSE COUNCIL, INC.; VERMONT PUBLIC INTEREST 15 RESEARCH GROUP; SAFER CHEMICALS HEALTHY FAMILIES; LAUREN 16 ATKINS; WENDY HARTLEY; and HALOGENATED SOLVENTS 17 INDUSTRY ALLIANCE, INC., 18 19 Petitioners, 20 21 v. 22 23 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY; and 24 MICHAEL S. REGAN, * as Administrator of the United States Environmental 25 Protection Agency, 26 27 Respondents. 28 _____________________________________ 29 30 Before: 31 32 LEVAL, CABRANES, and RAGGI, Circuit Judges. 33

*Pursuant to Federal Rule of Appellate Procedure 43(c)(2), Administrator Michael S. Regan is automatically substituted as Respondent. The Clerk of the Court is respectfully directed to amend the caption as set forth above. 1 Petitioner Halogenated Solvents Industry Alliance, Inc. (“HSIA”) 2 challenges a Final Rule published by the Environmental Protection Agency 3 (“EPA”) restricting access by consumers to methylene chloride, a dangerous 4 chemical used in paint removal products, arguing that (i) the rule’s method of 5 restricting consumer use is arbitrary and capricious because of its incidental 6 impact on commercial uses of methylene chloride and (ii) it is unsupported 7 by substantial evidence because EPA failed to adequately consider the costs 8 of the Proposed Rule. A group of Environmental Petitioners also challenges 9 the rule, contending that the Toxic Substances Control Act,

, et 10 seq. (“TSCA”) required the EPA to regulate commercial uses of methylene 11 chloride as well as consumer uses. Held, (a) HSIA’s challenge to the Final 12 Rule fails because the Final Rule was supported by substantial evidence; (ii) 13 the Environmental Petitioners’ challenge is prudentially unripe for review at 14 this time. The petitions for review of the Final Rule are DENIED. 15 16 JONATHAN KALMUSS-KATZ (Eve C. 17 Gartner, on the brief), Earthjustice, New 18 York, NY, for Petitioner Labor Council for 19 Latin American Advancement. 20 21 THOMAS ZIMPLEMAN, NATURAL 22 RESOURCES DEFENSE COUNCIL, 23 WASHINGTON, DC, for Petitioner Natural 24 Resources Defense Council. 25 26 ROBERT M. SUSSMAN, SUSSMAN & 27 ASSOCIATES, WASHINGTON, DC, for 28 Petitioners Vermont Public Interest 29 Research Group, Safer Chemicals Healthy 30 Families, Lauren Atkins, and Wendy 31 Hartley. 32 33 W. CAFFEY NORMAN, Squire Patton 34 Boggs (US) LLP, Washington, DC; 35 KEITH BRADLEY (Alexander Arensberg, 36 on the brief), Squire Patton Boggs (US) 37 LLP, Denver, CO, for Petitioner 38 Halogenated Solvents Industry Alliance, 39 Inc.

2 1 2 DANIEL DEPASQUALE, BETHANY FISHER, 3 Office of the General Counsel, United 4 States Environmental Protection 5 Agency, Washington, DC; JEFFREY 6 BOSSERT CLARK, Assistant Attorney 7 General; JONATHAN BRIGHTBILL, 8 Principal Deputy Assistant Attorney 9 General; SARAH A. BUCKLEY, Trial 10 Attorney, United States Department of 11 Justice, Washington, DC, for 12 Respondents. 13 LEVAL, Circuit Judge:

14 This case involves two petitions for review of a Final Rule of the United

15 States Environmental Protection Agency (“EPA”). The rule restricts consumer

16 uses of methylene chloride, a chemical used in paint removal products, by

17 prohibiting the distribution of products containing methylene chloride to and

18 by retailers. Petitioner Halogenated Solvents Industry Alliance, Inc., (“HSIA”)

19 contends that the Final Rule’s undertaking to prevent consumer use of the

20 chemical by banning retail distribution should be set aside (1) because in

21 addition to consumer uses targeted by the Final Rule, that prohibition on

22 retailers incidentally also restricts commercial uses by small businesses, which

23 frequently purchase methylene chloride from retailers because their needs are

24 for smaller quantities; and (2) because EPA gave inadequate consideration to

3 1 costs imposed by the rule. Petitioners Labor Council for Latin American

2 Advancement; Natural Resources Defense Council, Inc.; Vermont Public

3 Interest Research Group; Safer Chemicals Healthy Families; Lauren Atkins;

4 and Wendy Hartley (collectively, “Environmental Petitioners”) contend that

5 the Toxic Substances Control Act,

, et seq. (“TSCA”) required

6 the EPA to regulate commercial uses of methylene chloride as well as consumer

7 uses, and that EPA’s failure to do so requires that the Final Rule be expanded

8 to encompass commercial uses.

9 In response to HSIA, EPA argues that TSCA required it to impose rules

10 that would ensure that the risks posed by consumer uses of methylene

11 chloride are “no longer present[ed],”

(a), and that the

12 consumer use restriction effectuated by prohibiting sales to and by retailers

13 was a reasonable means, supported by substantial evidence, of achieving this

14 end. In response to the Environmental Petitioners’ argument that commercial

15 uses of methylene chloride should also have been restricted, EPA argues that,

16 because it is still considering how to appropriately regulate commercial uses,

17 the agency’s action on this question is not yet final or subject to judicial

18 review.

4 1 We conclude that EPA’s implementation of a retailer distribution ban

2 was a reasonable means to achieve its required goal of ensuring that the risks

3 posed by consumer uses of methylene chloride were “no longer present[ed].”

4

(a). With respect to Environmental Petitioners’ claim

5 regarding regulation of commercial uses, we conclude that it is prudentially

6 unripe for judicial review at this time. Accordingly, the petitions for review of

7 the challenged Final Rule are DENIED.

8 BACKGROUND

9 I. Methylene Chloride and EPA’s Evaluation of its Risks

10 TSCA imposes a duty on EPA to “conduct risk evaluations . . . to

11 determine whether a chemical substance presents an unreasonable risk of

12 injury to health or the environment, without consideration of costs or other

13 nonrisk factors.”

(b)(4)(A). Under § 2605(a), if the

14 Administrator of EPA determines that a chemical “presents an unreasonable

15 risk of injury to health or the environment, the Administrator shall by rule . . .

16 [impose] requirements to such substance . . . to the extent necessary so that [it]

17 no longer presents such risk.” In this opinion, we refer to rules promulgated

5 1 by EPA under this section, such as the Final Rule that is the subject of the

2 Petitioners’ challenge, as “§ 2605(a) rules.”

3 Methylene chloride is a chemical used as a solvent with a variety of

4 commercial and consumer use applications, including as a component of

5 paint removal products. EPA first initiated a “comprehensive regulatory

6 investigation” of the risks posed and options to regulate methylene chloride

7 in 1985 but took little action with respect to that investigation until 2012. See

8 Methylene Chloride; Initiation of Regulatory Investigation,

42,038 (Oct. 17, 1985). In February 2012, the Center for Disease Control and

10 Prevention (“CDC”) issued a report identifying thirteen deaths from the use

11 of methylene chloride paint strippers in commercial bathtub refinishing. That

12 report noted that the widespread availability of such products—many of

13 which consisted of 60-90% methylene chloride—“puts both professional

14 bathtub refinishers and do-it-yourselfers at risk.” Joint App’x 39.

15 In June 2012 (prior to TSCA’s amendment in 2016), EPA included

16 methylene chloride on its TSCA Work Plan, a list of chemicals that EPA

17 planned to assess under TSCA. EPA produced a draft risk assessment of

18 methylene chloride’s paint stripping uses in January 2013 and finalized the

6 1 risk assessment in August 2014 (hereafter “2014 Risk Assessment”). The 2014

2 Risk Assessment identified numerous risks arising from the use of paint

3 strippers containing methylene chloride, including risks of acute exposure

4 causing “death; neurological impacts such as coma, incapacitation, loss of

5 consciousness, and dizziness; and liver effects,” and risks of chronic exposure

6 causing “brain cancer, liver cancer, non-Hodgkin lymphoma, and multiple

7 myeloma.” Methylene Chloride and N-Methylpyrrolidone; Regulation of

8 Certain Uses Under TSCA Section 6(a),

, 7,468, 7,471

9 (proposed Jan. 19, 2017) (hereafter “Proposed Rule”). The 2014 Risk

10 Assessment, though noting these risks, was, as EPA points out, “a scientific

11 document,” which “[a]t no point . . . purport[ed] to make a policy-based

12 determination that the identified risks were ‘unreasonable risks’ under

13 [Section] 2605(a).” EPA Br. 10; see also Joint App’x 169-70. Still, there was

14 evidence in the 2014 Risk Assessment that persons engaged in bathtub

15 refinishing using products containing less than 85% methylene chloride were

16 exposed to concentrations of methylene chloride at levels characterized as

17 “Immediately Dangerous to Life and Health,” and that 49 deaths had been

7 1 caused by methylene chloride since 1976. EPA took no action to characterize

2 these risks as “unreasonable” under § 2605(a) until 2017.

3 II. The 2017 Proposed Rule

4 In 2017, EPA proposed a § 2605(a) rule regarding commercial and

5 consumer uses of methylene chloride in paint and coating removal. See 2017

6 Proposed Rule,

. The Proposed Rule was an exercise of the

7 EPA’s discretionary authority under

(l)(4), which permits

8 promulgation of § 2605(a) rules for chemicals, such as methylene chloride, for

9 which EPA had “published a completed risk assessment prior to June 22,

10 2016.”

(l)(4). Relying on the 2014 Risk Assessment, EPA

11 proposed to determine that both acute and chronic “methylene chloride

12 exposures during paint and coating removal present unreasonable risks.”

13 2017 Proposed Rule, 82 Fed. Reg. at 7,478. Accordingly, EPA proposed to

14 “prohibit the manufacture (including import), processing, and distribution in

15 commerce of methylene chloride for all consumer and for most types of

16 commercial paint and coating removal uses,” and “to prohibit the use of

17 methylene chloride for commercial paint and coating removal in [several]

18 specified sectors.” Id. at 7,465. EPA did not propose to “regulate the use of

8 1 methylene chloride in commercial furniture refinishing . . . or refinishing

2 conducted by professionals or commercial workers,” but noted that it

3 “intend[ed] to issue a separate proposal on methylene chloride in paint and

4 coating removal in commercial furniture refinishing” and that it “plan[ned] to

5 issue one final rule covering both this proposal and the future proposed rule

6 on methylene chloride in paint and coating removal in commercial furniture

7 refinishing.” Id. Finally, the EPA proposed to require that any products

8 containing methylene chloride intended for paint removal be distributed in

9 containers not less than 55 gallons and to require certain downstream

10 notification requirements regarding the prohibition against manufacturing

11 and distribution. Id. These notification requirements would apply only to

12 “manufacturers . . . , processors, and distributors” and not “retailers”; the

13 Proposed Rule defined “retailer” as “a person or business who distributes in

14 commerce a chemical substance, mixture, or article to consumer end users.”

15 Id. at 7,526, 7,529.

16 The Proposed Rule considered several regulatory alternatives to the

17 distribution ban and container-size restrictions:

9 1 First, it considered whether the unreasonable risk could be eliminated

2 by warning labels; it concluded that “[p]resenting information about

3 methylene chloride on a product label would not adequately address the

4 unreasonable risk . . . because the nature of the information the user would

5 need to read, understand, and act upon is extremely complex.” Id. at 7,474.

6 Though EPA “reason[ed] that revised labeling w[ould] not address the

7 unreasonable risk presented by methylene chloride in paint and coating

8 removal,” it sought public comments on “enhanced labeling requirements for

9 consumer paint and coating removal products containing methylene

10 chloride” based on recommendations from the Small Business Advocacy

11 Review (“SBAR”) Panel. Id.

12 Second, EPA considered regulations requiring the use of respirators,

13 but found that “[a]cute risks of incapacitation, coma, or death in workers

14 exposed to methylene chloride . . . are present even when respiratory

15 protection is used” “[i]n some industries with high exposure scenarios,” id. at

16 7,471, and that “not all workers may be able to wear respirators,” id. at 7,481.

17 Third, EPA considered regulating consumer and commercial uses of

18 methylene chloride separately, but found that products containing methylene

10 1 chloride “cannot be straightforwardly restricted to a single type of project or

2 user.” Id. at 7,479.

3 Fourth, EPA conducted a “limited evaluation” of a “training and

4 certification program for commercial paint and coating removers” as

5 recommended by the SBAR, but found that “effective risk reduction from

6 commercial use . . . would require additional regulation of distributors of

7 these products” to “ensur[e] that only trained and certified commercial users

8 are able to access these paint and coating removal products,” which the EPA

9 viewed “as a significant limitation for this approach.” Id. at 7,474. The EPA

10 sought public comment “on the feasibility of such a program.” Id.

11 EPA received tens of thousands of comments in response to the 2017

12 Proposed Rule (many the result of mass-mailing campaigns). A substantial

13 majority of those comments supported the Proposed Rule and determination

14 that the use of methylene chloride in both consumer and commercial paint

15 stripping posed an unreasonable risk of injury to health. EPA also received a

16 comment from the SBAR Panel, which recommended, as an alternative to a

17 distribution ban, a training and certification program for commercial uses of

18 products containing methylene chloride. The SBAR report included

11 1 comments from Small Entity Representatives (“SERs”) claiming that EPA had

2 underestimated the cost of reformulating products containing methylene

3 chloride and that increased costs would cause small entities to go out of

4 business. The Small Business Administration urged the EPA to “take back the

5 rule” or, alternatively, to “reassess the viability and technical feasibility of the

6 available alternatives, reevaluate the costs to formulators, and eliminate the

7 restriction on the container size for these chemical products.” Joint App’x 720.

8 The Department of Defense submitted comments urging EPA to adopt an

9 approach that would restrict access to methylene chloride by consumers

10 while still making it available in industrial settings. And in 2018, after the

11 comment period had ended, Petitioner HSIA submitted a white paper to the

12 Small Business Administration recommending that EPA consider a training,

13 certification, and limited access program for commercial uses.

14 III. The Challenged Final Rule

15 On March 27, 2019, EPA promulgated the final rule at issue in this

16 appeal. Methylene Chloride; Regulation of Paint and Coating Removal for

17 Consumer Use Under TSCA Section 6(a),

(Mar. 27, 2019)

18 (hereafter “Final Rule”). The Final Rule set forth a determination by EPA that

12 1 “the use of methylene chloride in consumer paint and coating removal

2 presents an unreasonable risk of injury to health due to acute human

3 lethality,”

(emphasis added); on the other hand, it did not make a

4 final determination—as it had proposed to do—that commercial uses posed an

5 unreasonable risk. Instead, EPA published, on the same day, an Advanced

6 Notice of Proposed Rule Making (“2019 ANPRM”) “on questions related to a

7 potential training, certification, and limited access program as an option for

8 risk management for all of the commercial uses of methylene chloride in paint

9 and coating removal.” Id.; see also Methylene Chloride; Commercial Paint and

10 Coating Removal Training, Certification and Limited Access Program,

Reg. 11,466 (Mar. 27, 2019) (hereafter “2019 ANPRM”).

12 To ensure that consumer uses of products containing methylene

13 chloride would “no longer present[]” the identified unreasonable risk in

14 consumer products, the Final Rule prohibited the “manufacturing, processing

15 and distributing in commerce methylene chloride for consumer paint and

16 coating removal” and prohibited the distribution in commerce of methylene

17 chloride (or products containing it) both to and by “retailers.” 2019 Final Rule,

18 84 Fed. Reg. at 11,435. The Final Rule defined “retailer” as:

13 1 a person who distributes in commerce or makes available a 2 chemical substance or mixture to consumer end users, including 3 e-commerce internet sales or distribution. Any distributor with at 4 least one consumer end user customer is a considered a retailer. 5 A person who distributes in commerce or makes available a 6 chemical substance or mixture solely to commercial or industrial 7 end users or solely to commercial or industrial businesses is not 8 considered a retailer.

9 Id.

10 EPA considered and rejected a restriction on the distribution of

11 methylene chloride paint strippers in containers with a volume less than 55

12 gallons along with downstream notification requirements, which it

13 characterized as the “primary alternative regulatory action.” Id. at 11,427. It

14 determined that the ban on sales to and by retailers was more cost effective

15 than the container-size restriction because it “achieve[d] the necessary risk

16 reduction . . . with estimated lower costs” than the container-size restriction,

17 which would have caused costs to be “higher due to the cost of compliance

18 with the container volume requirements which impact commercial users not

19 targeted by the rule.” Id.

20 As noted above, the Final Rule did not undertake to regulate

21 commercial uses of methylene chloride, nor did it determine that such uses

22 present an unreasonable risk of injury to health or the environment. Instead, it

14 1 proposed in the 2019 ANPRM that a training and certification program,

2 combined with limited access by commercial users, “could allow access to

3 paint and coating removal products containing methylene chloride only to

4 commercial users who are certified as properly trained to engage in use

5 practices that do not present unreasonable risks.” 2019 ANPRM,

at 11,466. Though the 2017 Proposed Rule had already sought comments on

7 such a program, EPA received only one responsive comment, from the

8 Environmental Defense Fund, which was sharply critical.

. But, as

9 previously noted, in 2018, following the close of the comment period, HSIA

10 submitted a white paper advocating for such a training and certification

11 program.

EPA noted that such a program was similar to one used in the

12 United Kingdom, where access to methylene chloride is restricted to certified

13 commercial end users, while unobtainable by consumer end users.

at

14 11,469.

15 On April 18, 2019, Environmental Petitioners filed their petition in this

16 court for review of the Final Rule. On May 24, 2019, HSIA filed its petition for

17 review of the Final Rule in the D.C. Circuit, which granted EPA’s motion to

15 1 transfer the petition to this court. On August 21, 2019, this court consolidated

2 the cases into this appeal.

3 DISCUSSION

4 I. The Toxic Substances Control Act (“TSCA”) and its Application to EPA’s 5 Evaluations and Regulations of Methylene Chloride

6 TSCA, originally enacted in 1976, was intended “to prevent

7 unreasonable risks of injury to health or the environment associated with the

8 manufacture, processing, distribution in commerce, use, or disposal of

9 chemical substances.” S. Rep. No. 94-698, at 1 (1976), as reprinted in 1976

10 U.S.C.C.A.N. 4491, and to give EPA “adequate authority . . . to regulate

11 chemical substances and mixtures which present an unreasonable risk of

12 injury to health or the environment.”

(b)(2).

13 The nature of EPA’s duties and powers under TSCA has changed over

14 time. Prior to 2016, § 2605 did not prescribe procedures for conducting

15 chemical risk evaluations, the initiation of which was within EPA’s discretion,

16 and the EPA had identified very few chemicals subject to § 2605(a)’s mandate.

17 If chemicals were determined, prior to 2016, to present an unreasonable risk

18 of injury to health or the environment, TSCA required the EPA to regulate

19 them only to the extent necessary “to protect adequately against such risk” and

16 1 in so regulating to use “the least burdensome requirements,” § 2605(a) (2012)

2 (emphasis added) (amended 2016), which some courts interpreted to require

3 the EPA to balance the economic costs of proposed regulatory restrictions

4 against the environmental benefits those restrictions would provide, see, e.g.,

5 Corrosion Proof Fittings v. EPA,

(5th Cir. 1991).

6 The 2016 amendments to TSCA substantially increased EPA’s

7 obligation to evaluate and regulate dangerous chemicals. Instead of leaving

8 the completion of risk evaluations to EPA’s discretion, TSCA now requires

9 the EPA to conduct risk assessments for a minimum number of chemicals,

10 subject to statutory deadlines.

(b)(2)(A), (b)(1)(B)(i), (b)(4)(D).

11 It also prescribes detailed requirements for these chemical risk evaluations,

12 including that the determination whether a chemical presents an

13 unreasonable risk of injury to health or the environment shall be reached

14 “without consideration of costs or other nonrisk factors.” § 2605(b)(4)(A). And

15 it imposes statutory deadlines for regulation of a chemical found to present

16 an unreasonable risk of injury to health or the environment under any of its

17 conditions of use. For such chemicals, the amended statute requires EPA to

18 propose a risk management rule within one year, and finalize that rule within

17 1 two years, subject to a possible two-year extension provided certain

2 conditions are met. § 2605(c)(1).

3 The amended statute also requires more stringent regulation of

4 chemicals identified as posing an unreasonable risk, replacing the previous

5 mandate “to protect adequately” against identified unreasonable risks with

6 an obligation to regulate the substance “to the extent necessary so that [it] no

7 longer presents such risk.” Compare § 2605(a) (2012) (amended 2016), with

8 § 2605(a) (2018) (current) (emphasis added). And the statute no longer

9 requires EPA to adopt the “least burdensome requirements” when regulating

10 chemicals that pose an unreasonable risk to health or the environment.

11 This does not mean that the EPA is free to ignore costs of regulating

12 such chemicals. When promulgating a rule under § 2605(a), as amended, EPA

13 must still “factor in, to the extent practicable,” several considerations,

14 including the “effects of the chemical . . . on the environment,” “the benefits

15 of the chemical . . . for various uses,” and “the reasonably ascertainable

16 economic consequences of the rule.” § 2605(c)(2)(A)-(B). The “factor[ing] in”

17 of reasonably ascertainable economic consequences includes consideration of

18 “the costs and benefits of the proposed and final regulatory actions and of the

18 1 1 or more primary alternative regulatory actions considered by the

2 Administrator.” § 2605(c)(2)(A)(iv). “[I]n deciding whether to prohibit or

3 restrict in a manner that substantially prevents a specific condition of use of a

4 chemical substance or mixture . . . [EPA] shall consider, to the extent

5 practicable, whether technically and economically feasible alternatives that

6 benefit health or the environment, compared to the use so proposed to be

7 prohibited or restricted, will be reasonably available as a substitute when the

8 proposed prohibition or other restriction takes effect.” § 2605(c)(2)(C). EPA’s

9 duty to consider costs, as contemplated by these statutory provisions, is

10 subject to the overall mandate to regulate the chemical to the extent that it “no

11 longer presents” the identified unreasonable risk. § 2605(a).

12 Shortly prior to the 2016 amendment, EPA had completed risk

13 evaluations for several chemicals, including methylene chloride. TSCA’s

14 amendment addressed such “chemical substance[s] . . . for which the

15 Administrator has published a completed risk assessment prior to June 22,

16 2016.” § 2625(l)(4). Rather than requiring EPA to re-complete risk assessments

17 for these chemicals, the 2016 amendment provides that “the Administrator

18 may publish proposed and final rules under section 2605(a) of this title that

19 1 are consistent with the scope of the completed risk assessment for the

2 chemical substance and consistent with other applicable requirements of

3 section 2605 of this title.” Id.

4 Because § 2625(l)(4) provides that EPA “may” publish and propose

5 § 2605(a) rules regarding chemicals for which EPA had already completed a

6 risk assessment, EPA’s decision, based on the 2014 Risk Assessment,

7 regarding whether to determine that consumer and commercial uses of

8 methylene chloride pose an unreasonable risk was not subject to the same

9 statutory deadlines as the same decision would be if based on a risk

10 evaluation completed after TSCA’s amendment. However, in 2016, EPA

11 designated methylene chloride as one of ten chemicals that would be the

12 subject of its required initial risk evaluation under the 2016 TSCA

13 amendment. After the 2019 Final Rule and ANPRM, EPA published a draft

14 risk evaluation for methylene chloride that included its use in commercial

15 paint and coating removal. That draft risk evaluation proposed to find that

16 such commercial use presents an unreasonable risk of injury to health.

17 Because this new risk evaluation—unlike the 2014 Risk Assessment—was

18 undertaken in compliance with the 2016 Amendment, it is subject to the

20 1 statutory deadlines requiring the risk evaluation to be finalized by June 2020.

2 § 2605(b)(4)(G). On June 24, 2020, consistent with this statutory deadline, EPA

3 finalized this risk evaluation, determining that commercial use of methylene

4 chloride in paint and coating removal presents an unreasonable risk of injury

5 to health. Methylene Chloride (MC); Final Toxic Substances Control Act

6 (TSCA) Risk Evaluation; Notice of Availability (“2020 Final Risk Evaluation”),

7

. Under § 2605(c)(1)(B), EPA must finalize a § 2605(a) risk

8 management rule regarding these identified commercial uses within two

9 years of the publication of the 2020 Final Risk Evaluation, subject to extension

10 under § 2605(c)(1)(C).

11 II. Standard of Review

12 For judicial review of rules promulgated by EPA under § 2605(a), TSCA

13 provides a standard worded slightly differently from the standard established

14 by § 706 of the Administrative Procedure Act (“APA”). The APA’s standard

15 of review provides that reviewing courts shall set aside agency action that is

16 “unsupported by substantial evidence.”

(2)(E). “Substantial

17 evidence” under the APA has been understood to mean “such relevant

18 evidence as a reasonable mind might accept as adequate to support a

21 1 conclusion.” Universal Camera Corp. v. NLRB,

(1951). Under

2 that standard, a court will not set aside an agency’s action so long as it is

3 “supported by less than a preponderance but more than a scintilla of

4 evidence.” Sprint Spectrum L.P. v. Willoth,

(2d Cir. 1999)

5 (internal quotation marks omitted). “Substantial evidence [under the APA]

6 requires ‘something less than the weight of the evidence, and the possibility

7 of drawing two inconsistent conclusions from the evidence does not prevent

8 an administrative agency’s finding from being supported by substantial

9 evidence.’” Corrosion Proof,

(quoting Consolo v. Federal

10 Maritime Comm’n,

(1966)).

11 In contrast, § 2618(c)(1)(B) of TSCA provides, “[I]n the case of review

12 of . . . a rule under section . . . 2605(a) (including review of the associated

13 determination [of unreasonable risk]), . . . the standard of review prescribed

14 by [APA § 706(2)(E)] shall not apply and the court shall hold unlawful and set

15 aside such rule if the court finds that the rule is not supported by substantial

16 evidence in the rulemaking record taken as a whole.” 15 U.S.C.

17 § 2618(c)(1)(B).

22 1 Upon a straightforward reading of the text of these two provisions, it is

2 not clear how the different wordings change the standard. The D.C. Circuit

3 has sensibly observed that “Congress apparently contemplated that the TSCA

4 standard should be viewed as a distinct standard; otherwise there would

5 have been no need to specifically rule out the APA review standard.” Chem.

6 Mfrs. Ass’n v. EPA,

(D.C. Cir. 1988). Relying on TSCA’s

7 legislative history, that court held that TSCA’s substantial evidence standard

8 requires “more searching [review] than the judicial review undertaken in

9 most agency cases.”

. The Third and Fifth Circuits have reached

10 similar conclusions. See Ausimont U.S.A. Inc. v. EPA,

(3d Cir.

11 1988); Shell Chemical Co. v. EPA,

(5th Cir. 1987). Those courts

12 have asserted that the TSCA “substantial evidence” standard is a

13 “particularly demanding one,” as compared to the arbitrary and capricious

14 standard. Chem. Mfrs.,

(internal quotation marks omitted). We

15 agree with those circuits that TSCA’s “substantial evidence” standard is more

23 1 demanding on the agency than the standard of review otherwise prescribed

2 by the APA. 1

3 While we agree with the D.C. Circuit that Congress’s emphasis on the

4 fact that the standard of TSCA differs from the APA standard surely means

5 that Congress intended the two standards to be different, we find no need in

6 this case to reach a conclusion on the extent of the difference. Whether EPA’s

7 Final Rule is evaluated under a standard akin to APA’s substantial evidence

8 review or under a “more searching” TSCA substantial evidence standard

1 Environmental Petitioners insist that APA’s “arbitrary and capricious” standard of review survives TSCA’s statutory displacement of APA’s “substantial evidence” standard. EPA, in response, argues that Environmental Petitioners’ argument is “technically incorrect” but that the difference between the arbitrary and capricious standard and the substantial evidence standard is “largely semantic,” relying on Ass’n of Data Processing Serv. Orgs., Inc. v. Bd. of Governors of Fed. Rsrv. Sys.,

, 683-85 (D.C. Cir. 1984) (“ADPSCO”). We find neither argument persuasive. ADPSCO interpreted APA § 706(2)(E)’s “substantial evidence” standard, not TSCA’s “substantial evidence” standard, and, as noted above, the D.C. Circuit has since concluded that these standards are distinct. Chem. Mfrs.,

. Courts that have considered the question have rejected the survival of “arbitrary and capricious” review of TSCA rules, concluding instead that TSCA’s substantial evidence standard is “particularly demanding.” See, e.g.,

(“Congress perceived some difference between the standard it chose for TSCA and the APA’s arbitrary-and-capricious standard.”); see also Corrosion Proof,

(“Congress put the substantial evidence test in the statute because it wanted the courts to scrutinize the Commission’s actions more closely than an ‘arbitrary and capricious’ standard would allow.” (internal quotation marks omitted)). 24 1 adopted by other circuits, for the reasons described below, we conclude that

2 the Final Rule is adequately supported by substantial evidence in the

3 rulemaking record taken as a whole, and should not be set aside.

4 III. HSIA’s Challenge to the 2019 Final Rule

5 HSIA challenges the 2019 Final Rule on four grounds. It argues: (1) the

6 prohibition of sales to and by retailers was inconsistent with the EPA’s intent

7 to allow commercial uses, because many commercial users purchase products

8 containing methylene chloride products through retailers; (2) EPA provided

9 insufficient notice and opportunity to comment on the definition of “retailer”

10 in the final rule; (3) EPA’s assessment of the Final Rule’s impact on methylene

11 chloride product formulators was inadequate; and (4) EPA lacked substantial

12 evidence to support its prohibition on distribution to and by retailers. We

13 reject HSIA’s arguments.

14 1. The prohibition on sales of methylene chloride products to and by retailers is 15 not inconsistent with EPA’s stated policy.

16 HSIA argues that the incidental effect on commercial users of the Final

17 Rule’s ban on sales to or by retailers is inconsistent with EPA’s stated policy

18 of allowing continued access to methylene chloride products by commercial

19 users. HSIA points out that retail outlets are an important source of supply

25 1 for commercial users that use only modest quantities of products containing

2 methylene chloride. HSIA further argues that the retailer ban is inconsistent

3 with EPA’s reasoning for rejecting the 55-gallon minimum container

4 restriction, which EPA based on the restriction’s potential impact on small

5 commercial users who typically purchase methylene chloride products in

6 smaller quantities.

7 The first of these arguments is fundamentally flawed because it rests on

8 the mistaken premise that the Final Rule espoused a policy favoring

9 continued access to methylene chloride by commercial users. While it is true

10 that commercial uses were not “targeted by the rule,” 84 Fed. Reg. at 11,427,

11 neither did the Final Rule state or imply a policy encouraging, supporting, or

12 even approving the continuation of commercial uses. To the contrary, the

13 promulgation of the Final Rule in 2019 intentionally left open and under

14 consideration the questions whether and how to regulate commercial uses.

15 EPA subsequently reached a determination that commercial uses of

16 methylene chloride products present an unreasonable risk of injury to health,

17 triggering the statutory timeline for finalizing a § 2605(a) rule in the near

18 future. The Final Rule’s incidental effect on commercial users’ ability to access

26 1 methylene chloride products could not be inconsistent with EPA’s policy of

2 allowing such access because the EPA had established no such policy.

3 Nor does the Final Rule prevent commercial users from obtaining

4 methylene chloride products, although it may cause some commercial users

5 to seek different sources from those that they used in the past. EPA

6 considered this very possibility, noting that the Final Rule “potentially creates

7 a new marketspace for wholesalers and they may now sell these products to

8 commercial users who previously purchased from retail stores,” and that,

9 although currently “[w]holesalers tend not to sell products in smaller

10 quantities, . . . with the change in the marketspace, [they] may choose to do so

11 if such an action would be profitable.” Joint App’x 1023. EPA’s rejection of the

12 55-gallon minimum container restriction, rather than being inconsistent with

13 its adoption of the retailer ban, supports the possibility of this evolving

14 marketspace by allowing continued wholesale distribution of methylene

15 chloride products in smaller units to replace the sales previously made by

16 retailers to commercial users of smaller quantities.

27 1 2. The definition of retailer in the Final Rule was a “logical outgrowth” of the 2 Proposed Rule, and so gave sufficient notice and opportunity to comment.

3 HSIA contends that EPA provided insufficient notice and opportunity

4 to comment on the definition of “retailer” in the final rule. EPA was required

5 to provide notice of “either the terms or substance of the proposed rule or a

6 description of the subjects and issues involved.”

(b)(3) (emphasis

7 added); see

(c)(3) (noting that

applies to

8 § 2605(a) rules). “Courts of Appeals have generally interpreted this to mean

9 that the final rule the agency adopts must be a logical outgrowth of the rule

10 proposed.” Long Island Care at Home, Ltd. v. Coke,

(2007)

11 (internal quotation marks omitted); see also Nat’l Black Media Coal v. FCC, 791

, 1022 (2d Cir. 1986). Accordingly, “a final rule need not be an exact

13 replica of the rule proposed in the Notice,” Nat’l Black Media, 791 F.2d at 1022,

14 and the standard is generally satisfied if the notice given by the agency fairly

15 apprises interested persons of the subjects and issues that will be resolved by

16 the adoption of a final rule. See Riverkeeper, Inc. v. EPA,

, 113 (2d

17 Cir. 2007), rev’d on other grounds sub nom. Entergy Corp. v. Riverkeeper, Inc., 556

(2009). We have explained that “an agency may modify a rule

19 through the notice-and-comment process so long as the agency’s modification

28 1 is rational and ‘the agency’s path may reasonably be discerned.’” Cooling

2 Water Intake Structure Coal. v. EPA,

(2d Cir. 2018) (quoting

3 Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm,

(1983)).

4 TSCA additionally requires EPA to “publish a notice of proposed rulemaking

5 stating with particularity the reason for the proposed rule.” 15 U.S.C.

6 § 2605(c)(3)(A).

7 HSIA argues (1) that EPA’s retailer ban is not a “logical outgrowth” of

8 the Proposed Rule because the retailer ban is inconsistent with the proposed

9 55-gallon restriction, which would have allowed at least some sales to and by

10 retailers, as well as with the Proposed Rule’s carveout for furniture

11 refinishers; and (2) that, given the change in text and purpose of the definition

12 of retailer as between the Proposed Rule and the Final Rule, EPA gave

13 inadequate notice. In support of this argument, HSIA contends that “despite

14 the enormous number of comments in the record, not a single commenter

15 addressed a ban on sales to or by retailers,” though some commenters

16 opposed bans on sales for commercial use.

17 We reject HSIA’s argument. We find that EPA satisfied the “logical

18 outgrowth” standard as we have interpreted it and complied with TSCA’s

29 1 additional procedural requirements with respect to notice. EPA’s extensive

2 descriptions of the health risks posed by methylene chloride, which the Final

3 Rule seeks to eliminate in the consumer use context, plainly satisfied the

4 requirement that it “state with particularity the reason” for the proposed

5 regulation. The Proposed Rule made clear that the EPA was considering

6 prohibiting “the manufacture (including import), processing, and distribution

7 in commerce of methylene chloride for consumer and most types of

8 commercial paint and coating removal.” 82 Fed. Reg. at 7,464. And the

9 Proposed Rule described the difficulty of entirely disentangling regulation of

10 consumer uses from regulation of commercial uses, given that “paint and

11 coating removal products containing methylene chloride frequently are

12 available in the same distribution channels to consumers and professional

13 users” and “cannot be straightforwardly restricted to a single type of project

14 or user.” Id. at 7,479, 7,505. In other words, the Final Rule, which restricts

15 distribution of methylene chloride paint removal products only in commercial

16 channels that reach consumers, is considerably less restrictive than the

17 regulation considered by the Proposed Rule, and its incidental impact on

18 commercial users reflects the difficulty of disentangling consumer and

30 1 commercial uses described by the Proposed Rule. Indeed, commercial users

2 have considerably greater access to methylene chloride products under the

3 Final Rule than they would have had under the regulation considered by the

4 Proposed Rule.

5 EPA gave notice that it was contemplating a rule that would drastically

6 reduce or even eliminate access to certain products containing methylene

7 chloride. The restriction ultimately adopted in the Final Rule was

8 considerably less extreme than the contemplated restriction announced in the

9 Proposed Rule. Interested parties had an opportunity to comment not only on

10 the more extreme level of restriction that would have resulted from adoption

11 of the Proposed Rule, but also on less extreme restrictions the agency might

12 settle on within the scope of the proposed restrictions announced.

13 Acceptance of HSIA’s concept of the notice and comment obligation

14 would substantially freeze EPA’s consideration of the Final Rule to an “all or

15 nothing” choice of adopting or categorically rejecting exactly what was

16 originally proposed. It would unreasonably encumber and delay agency

17 action, forcing the agency to choose between ignoring commentary

18 suggesting useful modifications of proposed rules, or endlessly delaying

31 1 action until submitted commentary and further study failed to suggest any

2 desirable modification. Such an interpretation of the notice and comment

3 requirement would seriously harm the ability of agencies to deal flexibly with

4 pressing problems. More importantly, such an interpretation would be

5 plainly inconsistent with the statutory standard requiring that the “notice of

6 proposed rulemaking . . . include . . . either the terms or substance of the

7 proposed rule or a description of the subjects and issues involved.” 5 U.S.C.

8 § 553(b)(3).

9 We conclude that EPA complied with its notice and comment

10 obligations and that the Final Rule was a logical outgrowth of its originally

11 noticed proposal.

12 3. EPA adequately considered costs to formulators of methylene chloride.

13 HSIA next argues that EPA failed to consider adequately the impact of

14 the Final Rule on formulators of products containing methylene chloride. We

15 disagree.

16 EPA estimated that the cost resulting from the Final Rule to formulators

17 who would have to develop a new line of products not containing methylene

18 chloride would be approximately $27,000 annualized over two decades. This

32 1 estimate was extrapolated from a survey addressing the manufacturing

2 marketspace for similar products in Canada, and an additional survey

3 regarding another chemical, trichloroethylene (also known as “TCE”), which

4 EPA used to confirm the applicability for a U.S. rulemaking of the first

5 survey’s study of a Canadian market. And EPA found that there are

6 “technically and economically feasible chemical substitutes or alternative

7 methods that are reasonably available to a consumer for almost every

8 situation in which methylene chloride is used to remove paints or coatings.”

9 2019 Final Rule, 84 Fed. Reg. at 11,427-28.

10 HSIA argues that this evidence was insufficient to support EPA’s

11 determination regarding the costs to formulators resulting from the Final

12 Rule and that it was undermined by three comments submitted in response to

13 the Proposed Rule. First, HSIA claims that the American Chemistry Council

14 informed EPA that the surveys on which it relied were not valid because

15 “replacing methylene chloride is a substantially different undertaking from

16 replacing [TCE].” HSIA Br. 43. But HSIA’s citation in support of its assertion

17 points to a comment of the American Chemistry Council that says nothing of

18 the sort. The comment “recommends that EPA provide fuller discussion that

33 1 explains why these [surveys] are appropriate to include in the costs

2 calculation,” but does not assert that the surveys were inadequate. Joint

3 App’x 760. Second, HSIA points to a comment from a small business

4 formulator who stated that 40% of its revenue was derived from methylene

5 chloride products and that a 55-gallon container restriction could result in the

6 loss of its business. But neither of these concerns undermine EPA’s calculation

7 of costs; under the Final Rule, the commenter is still able to formulate

8 methylene chloride products for distributors that exclusively serve

9 commercial users, to develop alternative products, and to continue packaging

10 its products in containers smaller than 55 gallons. Finally, HSIA relies on a

11 comment from the SBA claiming that product lines would “disappear”

12 because “there are no drop-in replacements for methylene chloride.” Joint

13 App’x 718-19. But, again, formulators are not prevented from developing

14 methylene chloride products for distribution to commercial users or for uses

15 other than paint and coating removers, and the EPA found evidence that

16 alternatives are economically and technically feasible, as indicated in part by

17 many retailers that, even prior to being required to do so by the Final Rule,

34 1 announced that they were voluntarily discontinuing the sale of methylene

2 chloride products.

3 In sum, the comments on which HSIA relies do not demonstrate that

4 EPA’s estimation of costs to formulators was inadequate, in large part

5 because those comments are based on the faulty premise that formulators can

6 no longer manufacture methylene chloride products—the Final Rule does not

7 prohibit manufacturing methylene chloride for commercial paint-stripping

8 uses or for certain non-paint-stripping uses. Record evidence reasonably

9 supports the conclusion that EPA considered the reasonably ascertainable

10 consequences of the Final Rule on formulators, as well as EPA’s quantitative

11 and qualitative conclusions regarding those consequences. In any event,

12 HSIA’s argument seems to assume that EPA is compelled to accept every

13 submitted comment as accurate and reconcile its ultimate rule to every such

14 comment. The requirement to produce a rule that is “supported by

15 substantial evidence in the rulemaking record taken as a whole,” 15 U.S.C.

16 § 2618(c)(1)(B), does not impose an obligation to reconcile the rule with every

17 comment submitted, much less to accept the validity of every such comment.

18 HSIA has failed to demonstrate that EPA’s estimation of the costs to

35 1 formulators of methylene chloride products is not supported by substantial

2 evidence.

3 4. EPA adequately considered the costs to retailers and distributors of 4 methylene chloride products.

5 Finally, HSIA argues that EPA failed to account adequately for the costs

6 to retailers of its prohibition of sales to and by retailers of methylene chloride

7 paint stripping products. It is true that costs to retailers were not estimated in

8 the EPA’s economic analysis of the Final Rule. EPA explained that this was

9 “because the potential cost impact on retailers is uncertain,” and that “costs to

10 retailers were not estimated because of these uncertainties, and this may

11 represent a category of costs that are excluded from the analysis.” Joint App’x

12 957, 1005. HSIA argues that these statements should be deemed a refusal by

13 the EPA to consider the costs to retailers. HSIA further argues that the EPA

14 failed to consider adequately the costs of its retail ban on distributors (who

15 would otherwise sell to retailers) and the cost to small commercial users from

16 the elimination of an important portion of their supply chain. The failure to

17 consider these costs, HSIA argues, was equivalent to EPA estimating the costs

18 to be zero. While HSIA acknowledges that the EPA need only rely on

19 “reasonably available information” and describe the “reasonably

36 1 ascertainable economic consequences” of the Final Rule, 15 U.S.C.

2 § 2605(c)(2)(A), it argues that EPA nonetheless cannot ignore a cost and that

3 EPA’s lack of information with respect to the retail ban’s costs was “its own

4 fault,” given the retail ban’s absence from the Proposed Rule, HSIA Br. at 52-

5 53. HSIA argues that, in contrast, EPA had extensive evidence of the costs that

6 would result from the 55-gallon container size restriction, because adequate

7 notice was provided of that restriction, permitting commenters to provide

8 such information.

9 We disagree that the EPA’s inability to quantify the costs of the Final

10 Rule to retailers, distributors, and small commercial users means that it

11 ignored those costs. The record rather shows that EPA found the costs

12 impossible to estimate because of the likely growth of a new marketspace for

13 commercial-only distribution and sales of alternative products. These

14 possibilities, the EPA reasoned, meant that the cost could potentially be

15 minimal, and that retailers “could be better off under the rule” if profit

16 margins on alternative products were higher. EPA Br. at 90 (collecting record

17 citations). For distributors, as previously discussed, supra 34-35, EPA

18 considered—though it could not quantify—costs to commercial end users; it

37 1 found that these costs were not likely to be significant because of the

2 availability of technically and economically feasible substitutes. See 2019 Final

3 Rule, 84 Fed. Reg. at 11,427-28. These available substitutes mean that

4 commercial end users who do not want to switch suppliers will have

5 substitute products available to them, and, in any event, will likely have

6 access to a new marketspace in which wholesalers distribute directly to

7 commercial users to meet the demand previously met by retailers.

8 These qualitative assessments of the costs to retailers, distributors, and

9 commercial end users were reasonable, unrebutted by record evidence, and

10 consistent with the EPA’s obligation to consider “reasonably available

11 information” in estimating such costs. Based on the record before the EPA, it

12 was reasonable to conclude that, to the extent the Final Rule would result in

13 some lost business for these entities, it was also likely to create new business

14 via alternative products and an evolving marketspace. Far from ignoring

15 these potential consequences of the Final Rule, EPA considered them,

16 described them, and concluded that potential for new markets to replace the

17 losses initially caused by the Final Rule supported the rule’s implementation.

18 Reasonable minds might have reached a different conclusion from the

38 1 evidence available to the EPA, but “the possibility of drawing two

2 inconsistent conclusions from the evidence does not prevent an

3 administrative agency’s finding from being supported by substantial

4 evidence.” Corrosion Proof,

(quoting Consolo,

).

5 * * *

6 In sum, having considered HSIA’s challenges to the Final Rule, we find

7 them unpersuasive. HSIA fails to demonstrate that EPA’s prohibition on sales

8 to and by retailers was not a reasonable means, supported by substantial

9 evidence, to ensure that the unreasonable risks of methylene chloride paint

10 removal products for consumer uses be “no longer present[ed].” § 2605(a).

11 We therefore deny HSIA’s petition to set aside the Final Rule.

12 IV. Environmental Petitioners’ Challenge to the 2019 Final Rule

13 Environmental Petitioners contend the 2019 Final Rule was defective by

14 reason of (i) EPA’s failure to determine that use of methylene chloride in

15 commercial paint and coating removal (as it determined for consumer uses)

16 “presents an unreasonable risk of injury to health or the environment,”

17

(a), as well as (ii) its failure to impose specific regulations

18 governing commercial use so as to remove the unreasonable risk. They

39 1 advance a forceful argument that, given years of scientific data revealing

2 significant risks of severe adverse health consequences, it was inescapable

3 that the chemical poses an unreasonable risk in commercial applications,

4 particularly in view of the fact that commercial workers characteristically

5 experience far higher degrees of exposure than consumers. Environmental

6 Petitioners point to a history of statements by EPA, prior to its adoption of the

7 Final Rule in 2019, acknowledging the significant health risks posed by

8 commercial uses of methylene chloride and EPA’s corresponding statement of

9 its intention in the 2017 Proposed Rule to reach a risk determination as to

10 both consumer and commercial uses. Environmental Petitioners also advance

11 the far more ambitious and less forceful argument that, in adopting the 2019

12 Final Rule, EPA was required by law not only to make a conclusive risk

13 evaluation but also to finalize regulations, either banning or controlling

14 commercial uses so that the risk would be “no longer present[ed],” 15 U.S.C.

15 § 2605(a).

16 EPA, in response, contends it made a reasonable decision to defer

17 reaching a determination for commercial uses pending further study of

18 possibilities of controlling risks in a commercial setting. It also advances

40 1 several arguments that there should be no judicial review of its deliberations

2 on commercial uses until it reaches final determinations. Among those

3 arguments, it asserts that its consideration of commercial uses is prudentially

4 unripe for judicial review, as judicial review at this time would involve

5 “judicial interference [before] an administrative decision has been formalized

6 and its effects felt in a concrete way by the challenging parties,” Abbott Labs. v.

7 Gardner,

(1967), without substantial alleviation of

8 hardship to the petitioners. EPA points out that it has not procrastinated, nor

9 ignored the significant risks arising from commercial uses of methylene

10 chloride. It rather opted to begin with the easier task of developing a

11 regulatory scheme for consumer uses and then turning to the more complex

12 issue of how best to regulate commercial uses, as evidenced by its issuance of

13 the 2019 AMPRM upon the release of the 2019 Final Rule, and its Final Risk

14 Evaluation in 2020, in which it reached the very conclusion as to risk that

15 Environmental Petitioners contend it was required to reach in the 2019 Final

16 Rule: that commercial uses of methylene chloride in paint and coating

17 removal present an unreasonable risk of injury to health.

41 1 Notwithstanding the considerable force of Environmental Petitioners’

2 focus on the dangerousness of methylene chloride, we agree with EPA that its

3 consideration of commercial uses is prudentially unripe for judicial review at

4 this time. The record supports EPA’s contention that judicial review at this

5 time would interfere in its consideration of the issue, would be no more likely

6 to advance than to hinder its arrival at a final determination, and, even

7 granting the relief Environmental Petitioners seek, would not necessarily

8 result in any reduction of harms from commercial use. Environmental

9 Petitioners have not shown that denial of the relief they now seek will subject

10 them to significant harms.

11 Under the doctrine of prudential ripeness, courts will decline to review

12 administrative action that would otherwise be reviewable under

13 constitutional and statutory standards because, upon a balancing of the

14 pertinent interests, it is preferable for judicial review to await a more

15 advanced state of administrative consideration. The standards for invocation

16 of the prudential ripeness doctrine are generally described as a two-prong

17 test. The first prong asks whether the issues are “fit” for judicial review,

18 which requires consideration of “whether the court or the agency would

42 1 benefit from postponing review until the policy in question has sufficiently

2 crystallized.” Fla. Power & Light Co. v. EPA,

(D.C. Cir.

3 1998) (internal quotation marks omitted). The second prong—the “hardship”

4 prong—asks “whether and to what extent the parties will endure hardship if

5 decision is withheld.” NYCLU v. Grandeau,

(2d Cir. 2008).

6 The court must consider whether “the interests of the court and the agency in

7 postponing review outweigh the interests of those seeking relief.” Nat’l Ass’n

8 of Regul. Util. Comm’rs v. Dep’t of Energy,

, 1428 (D.C. Cir. 1988).

9 These broad articulations of judicial discretion are not clearly defined, but

10 what is clear is the need for balancing of competing interests.

11 Considerations that favor invocation of the doctrine to defer judicial

12 review include the desirability of (i) avoiding involving courts in “abstract

13 disagreements over administrative policies,” Abbott Labs.,

; (ii)

14 preventing courts from exercising premature, unnecessary interference in

15 matters of governmental policy, see NYCLU v. Grandeau,

;

16 and (iii) avoiding pernicious, unnecessary delay and obstruction of

17 administrative progress, particularly where the “possibility that further

43 1 consideration [by the agency] will actually occur . . . is not theoretical, but

2 real,” Ohio Forestry Ass’n, Inc. v. Sierra Club,

(1998).

3 Considerations that weigh against deferring judicial review include

4 that (i) delaying judicial review can result in substantial harm to the interests

5 of those seeking review and (ii) judicial review can expedite successful

6 completion of the administrative task when an agency has embarked on a

7 route that does not comport with an obligatory legal framework.

8 Furthermore, the Supreme Court has recently noted “tension” between

9 exercise of prudential restraint and the Court’s “recent reaffirmation of the

10 principle that a federal court’s obligation to hear and decide cases within its

11 jurisdiction is virtually unflagging.” Lexmark Intern., Inc. v. Static Control

12 Components, Inc.,

(2014) (internal quotation marks omitted). 2

13 In general, the more the matter to be placed before the court involves a pure

14 issue of law, unaffected by factual considerations, the less the concern that

15 judicial review might interfere inappropriately with full, effective

16 administrative consideration or involve the court inappropriately in matters

2 The Supreme Court has not “resolve[d] the continuing vitality of the prudential ripeness doctrine,” Susan B. Anthony List v. Driehaus,

, 167 (2014). 44 1 of governmental policy. See NYCLU v. Grandeau,

(“[I]ssues

2 have been deemed [prudentially] ripe when they would not benefit from any

3 further factual development and when the court would be in no better

4 position to adjudicate the issues in the future than it is now.” (internal

5 quotations marks omitted)); see also Gary D. Peake Excavating Inc. v. Town Bd. of

6 Hancock,

(2d Cir. 1996) (finding ripe claims that were “purely

7 legal and may be decided without further factual development”).

8 We conclude that Environmental Petitioners’ challenge to the Final

9 Rule—on the ground that it should have also addressed and regulated

10 commercial uses—is prudentially unripe for review at this time. On the day

11 of its promulgation of the Final Rule, on March 27, 2019, EPA published an

12 ANPRM indicating its intent to proceed to the question of how to deal with

13 commercial uses. Then, one year and three months later, in June 2020, it

14 finalized a risk assessment determining that commercial uses posed an

15 unreasonable risk. By making that determination, the agency imposed on

16 itself a statutory deadline to finalize a § 2605(a) rule within two years, (subject

17 to the possibility of a two-year extension if certain conditions are met).

18 § 2605(c)(1). That record does not give substantial support to Environmental

45 1 Petitioners’ argument that EPA’s failure to include commercial uses in the

2 Final Rule was procrastination designed to postpone a resolution indefinitely.

3 Environmental Petitioners are undoubtedly correct that the agency’s record

4 on this question since it first recognized the adverse health risks of methylene

5 chloride is unimpressive. Nonetheless, however disinclined the EPA may

6 have been in the past to deal with this difficult issue, its more recent record

7 does not support the conclusion that the agency’s deferral of the commercial

8 question in 2019 was a device to stall resolution indefinitely. It rather

9 supports the conclusion that EPA now recognizes its obligations and is

10 pursuing them.

11 Environmental Petitioners lean heavily on the hardship prong of the

12 test of prudential ripeness, asserting that adverse health consequences will

13 result from continued access to methylene chloride in commercial use. We

14 cannot deny the possibility that delaying regulation of methylene chloride in

15 commercial uses might produce some harm. Indeed, if the delay occasioned

16 by our reliance on prudential ripeness were open-ended, Environmental

17 Petitioners would have a stronger argument against application of that

18 doctrine. The delay, however, is not open ended. In fact, given the steps EPA

46 1 has already taken, Environmental Petitioners have not successfully shown

2 that granting the relief sought would either bring about an earlier final

3 regulation or significantly reduce harms. Given that the deadline EPA has

4 taken on by finalizing the 2020 Final Risk Evaluation is rapidly approaching,

5 the harm resulting from EPA’s postponement of the risk assessment for

6 commercial use until after dealing with consumer use is not enormous. Even

7 assuming that the risk of harm to commercial users might have been slightly

8 reduced had EPA determined that those uses pose an unreasonable health

9 risk and regulated them when it passed the Final Rule in 2019, it does not

10 necessarily follow that future harms would be reduced by now granting the

11 relief that petitioners seek. Granting that relief at this time could as easily

12 have the effect of delaying the ultimate resolution and increasing the harms,

13 rather than reducing them. Court-imposed pressure to reach a final scheme of

14 regulation before the agency has adequately collected and studied the needed

15 information could cause the agency to reach an inadequate solution that fails

16 to protect against harms as effectively as EPA might have protected if given

17 sufficient time. Moreover, even if we were to order EPA to revise the

18 challenged Final Rule to adopt regulations restricting commercial uses, EPA

47 1 would still need to consider a variety of regulatory options, the comparative

2 effectiveness of those options in ensuring that unreasonable risks are no

3 longer presented, and the reasonably ascertainable economic consequences of

4 those potential regulations. As a result, it is unlikely that EPA could comply

5 with our order before the expiration of the deadline EPA has already imposed

6 on itself by publishing the 2020 Final Risk Evaluation.

7 Nor do we think Environmental Petitioners are correct in arguing that

8 the issue before the court is a pure question of law, such as disfavors

9 application of the doctrine of prudential ripeness. While judicial review

10 inevitably raises questions of law, the questions whether commercial use of

11 methylene chloride presents an unreasonable risk of harm; if so, how that risk

12 of harm should be neutralized; and whether EPA’s decision to delay

13 answering that question until after producing a final rule on consumer uses

14 was arbitrary, unreasonable, or not supported by substantial evidence are

15 very much dependent on factual considerations. It is not as if the issue in

16 dispute simply involved the interpretation of a statutory term or the

17 application of law to undisputed facts.

48 1 The deadline for a final risk management rule regarding commercial

2 uses of methylene chloride is rapidly approaching. We conclude that the

3 extent to which TSCA requires EPA to regulate commercial uses of methylene

4 chloride, and whether the rules EPA promulgates adequately do so, will be a

5 better fit for judicial review after that rulemaking process is complete and the

6 “policy in question has sufficiently crystallized.” Fla. Power & Light,

(internal quotation marks omitted). Judicial review at this time, in the

8 absence of a record that fully considered regulation of commercial uses, might

9 force the court to cope with abstract disagreements and involve itself in

10 matters of administrative policy without the benefit of illuminating

11 information. See Abbott Labs.,

(1967).

12 Accordingly, we hold that Environmental Petitioners’ challenges to the

13 2019 Final Rule are prudentially unripe for review at this time. Their petitions

14 for review are DENIED.

15 CONCLUSION

16 For the foregoing reasons, the petitions for review of the 2019 Final

17 Rule are DENIED.

49