19

- 1042 L Labor Council v. EPA UNITED STATES COURT OF APPEALS 1 FOR THE SECOND CIRCUIT 2 3 August Term, 20 20 4 5 ( Argued : March 4 , 20 21 Decided: September 1, 2021 ) 6 7 Docket No s

. 19

- 1042(L); 19

- 1044; 19

- 2329 8 9 10

_____________________________________ 11 12 LABOR COUNCIL FOR LATIN AMERICAN ADVANCEMENT; NATURAL 13 RESOURCES DEFENSE COUNCIL, INC.; VERMONT PUBLIC INTEREST 14 RESEARCH GROUP; SAFER CHEMICALS HEALTHY FAMILIES; LAUREN 15 ATKINS; WENDY HARTLEY; and HALOGENATED SOLVEN T S 16 INDUSTRY ALLIANCE, INC. , 17 18 Petitioners , 19 20

v. 21 22 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY; and 23 MICHAEL S. REGAN , * as Administrator of the United States Environmental 24 Protection Agency , 25 26 Respondents

. 27

_____________________________________ 28 29 Before: 30 31 LEVAL , CABRANES 

### , and RAGGI , Circuit Judges

. 32 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.2 Petitioner Halogenated Solvents Industry Alliance , Inc. (“HSIA”) 1 challenges a Final Rule published by the Environmental Protection Agency 2 (“EPA”) restricting access by consumers to methylene chloride, a dangerous 3 chemical used in paint removal products, arguing that (i) the rule’s method of 4 restricting consumer use is arbitrary and capricious because of its incidental 5 impact on commercial uses of methylene chloride and (ii) it is unsupported 6 by substantial evidence because EPA failed to adequately consider the costs 7 of the P roposed R ule. A group of Environmental Petitio ners also challenges 8 the rule, contending that the Toxic Substances Control Act, 15 U.S.C. § 2601, et 9 seq. (“TSCA”) required the EPA to regulate commercial uses of methylene 10 chloride as well as consumer uses

. Held, (a) HSIA’s challenge to the Final 11 Rule fa ils because the Final Rule was supported by substantial evidence ; (ii) 12 the Environmental Petitioners’ challenge is prudentially unripe fo r review at 13 this time. The petitions for review of the Final Rule are DENIED. 14 15 J ONATHAN K AL MUSS

- K ATZ (Eve C. 16 Gartner, on the brief ), Earthjustice, New 17 York, NY, for Petitioner Labor Council for 18 Latin American Advancement

. 19 20 T HOMAS Z IMPLEMAN , N ATURAL 21 R ESOURCES D EFENSE C OUNCIL , 22 W ASHINGTON , DC , for Petitioner Natural 23 Resources Defense Council

. 24 25 R OBERT M. S USSMAN , S USSMAN & 26 A SSOCIATES , W ASHINGTON , DC , for 27 Petitioners Vermont Public Interest 28 Research Group, Safer Chemicals Healthy 29 Families, Lauren Atkins, and Wendy 30 Hartley. 31 32 W. C AFFEY N ORMAN , Squire Patton 33 Boggs (US) LLP, Washington, DC; 34 K EITH B RADLEY (Alexander Arensberg, 35 on the brief ), Squire Patton Boggs (US) 36 LLP, Denver, CO, for Petitioner 37 Halogenated Solvents Industry Alliance, 38 Inc. 393 1 D ANIEL D EPASQUALE , B ETHANY F ISHER , 2 Office of the General Counsel, United 3 States Environmental Protection 4 Agency, Washington, DC; J EFFREY 5 B OSSERT C LARK , Assistant Attorney 6 General; J ON ATHAN B RIGHTBILL , 7 Principal Deputy Assistant Attorney 8 General; S ARAH A. B UCKLEY , Trial 9 Attorney, United States Department of 10 Justice, Washington, DC, for 11 Respondents

. 12 LEVAL , Circuit Judge : 13

This case involves two petitions for review of a Final Rule of the United 14
States Environmental Protection Agency (“EPA”)

. The rule restrict s consumer 15
uses of methylene chloride, a chemical used in paint removal products , by 16
prohibiting the distribution of products containin g methylene chloride to and 17
by retailers . Petitioner Halogenated Solvents Industry Alliance, Inc. , (“HSIA”) 18

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

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

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

retailers incidentally also r estricts commercial uses by small business es , which 22
frequently purchase methylene chloride from retailers because their needs are 23

for smaller quantiti es ; and (2) because EPA gave inadequate consideration to 244 costs imposed by the r ule

. Petitioners Labor Council for Latin American 1

Advancement ; Natural Resources Defense Council, Inc. ; Vermont Public 2
Interest Research Group ; Safer Chemicals Healthy Families ; Lauren Atkins ; 3
and Wendy Hartley (collectively, “Environmental Petitioners”) contend that 4
the Toxic Substances Control Act, 15 U.S.C. § 2601, et seq. (“TSCA”) required 5

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

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

. 8
In response to HSIA, EPA argues that TSCA required it to impose rules 9

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

chloride are “no longer present [ ed ] ,” 15 U.S.C. § 2605(a), and that the 11

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

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

end

. I n response to the Environmental Petitioners’ argument that commercial 14
uses of methylene chloride should also have been restricted , EPA argues that , 15

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

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

review

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

was a reasonable means to achieve its required goal of ensuring that the risks 2
posed by consumer uses of methylene chloride were “no longer present [ ed ] .” 3
15 U.S.C. § 2605(a). With respect to Environmental Petitioners’ claim 4
regarding regulation of commercial uses , we conclude that it is p rudentially 5
unripe for judicial review at this time. Accordingly, the petitions for review of 6
the challenged Final Rule are DENIED

. 7

BACKGROUND 8
I. Methylene Chloride and EPA’s Evaluation of its Risks 9
TSCA imposes a duty on EPA to “conduct risk evaluations . . . to 10
determine whether a chemical substance presents an unreasonable risk of 11
injury to health or the environment, without consideration of costs or other 12

nonrisk factors

. ” 15 U.S.C. § 2605(b)(4)(A). Under § 2605(a), if the 13

Administrator of EPA determines that a chemical “presents an unreasonable 14
risk of injury to health or the environment , the Administrator shall by rule . . . 15
[impose] requirements t o such substance . . . to the extent necessary so that [it] 16
no longer pr esents such risk.” In this opinion, w e refer to r ules promulgated 176 by EPA under this section, such as the Final Rule that is the subject of the 1
Petitioners’ challenge, as “§ 2605(a) rules.” 2
Methylene chloride is a chemical used as a solvent with a variety of 3
commercial and consumer use applications, including as a component of 4
paint removal products. EPA first initiated a “comprehensive regulatory 5
investigation” of the risks posed and options to regulate methylene chloride 6
in 1985 but took little action with respect to that investigation until 2012. See 7
Methylene Chloride; Init iation of Regulatory Investigation, 50 Fed. Reg. 8

42,0 38 (Oct. 17, 1985). In February 2012, the Center for Disease Control and 9
Prevention (“CDC”) issued a report identifying thirteen deaths from the use 10
of methylene chloride paint strippers in commercial ba thtub refinishing. That 11
report noted that the widespread availability of such products

— many of 12

which consisted of 60

- 90% methylene chloride

— “puts both professional 13

bathtub refinishers and do

- it

- yourselfers at risk.” Joint App’x 39. 14
In June 2012 (prior to TSCA’s amendment in 2016) , EPA included 15
methylene chloride on its TSCA Work Plan, a list of chemicals that EPA 16
planned to assess under TSCA . EPA produced a draft risk assessment of 17
methylene chloride’s paint stripping uses in January 2013 and finalized the 187 risk assessment in August 2014 (hereafter “2014 Risk Assessment”). The 2014 1

Risk Assessment identified numerous risks arising from the use of paint 2
strippers containing methylene chloride , including risks of acute exposure 3
causing “death ; neurological impacts such as coma, incapacitation, loss of 4

consciousness , and dizziness; and liver effects,” and risks of chronic exposure 5
causing “brain c ancer, liver cancer, non

- Hodgkin lymphoma, and multiple 6
myeloma

. ” Methylene Chloride and N

- Methylpyrrolidone; Regulation of 7
Certain Uses Under TSCA Section 6(a), 82 Fed. Reg. 7,464, 7 , 468 , 7 , 471 8
(proposed Jan. 19, 2017) (hereafter “Proposed Rule”) . The 201 4 Risk 9
Assessment, though noting these risks, was, as EPA points out , “a scientific 10

document , ” which “[a]t no point

. . . purport [ed] to make a policy

- based 11

determination that the identified risks were ‘unreasonable risks’ under 12
[Section] 2605(a).” EPA Br. 10 ; see also Joint App’x 169

- 70. Still, there was 13

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

refinish ing using products containing less than 85% methylene chloride were 15
exposed to concentrations of methylene chloride at levels characterized as 16
“Immediately Dangerous to Life and Health,” and that 49 deaths had been 178 caused by methylene chloride since 1976. EPA took no action to characterize 1
these risks as “unreasonable” under § 2605(a) until 2017. 2
II. The 2017 Proposed Rule 3
In 2017, EPA proposed a § 2605(a) rule regarding commercial and 4
consumer uses of methylene chloride in paint and coating removal. See 2017 5
Proposed Rule, 82 Fed. Reg. 7 , 464. The P roposed R ule was an exercise of the 6
EPA’s discretionary authority under 15 U.S.C. § 2625( l )(4), which permits 7
promulgation of § 2605(a) rules for chemicals, such as methylene chloride, for 8
which EPA had “published a completed risk assessment prior to June 22, 9

2016. ” 15 U.S.C. § 2625( l )(4)

. Relying on the 2014 Risk Assessment, EPA 10
proposed to determine that both acute and chronic “methylene chloride 11
exposures during paint and coating removal present unreasonable risks.” 12
2017 Proposed Rule, 82 Fed. Reg. at 7 , 478 . Acco rdingly, EPA proposed to 13
“prohibit the manufacture (including import), processing, and distribution in 14
commerce of methylene chloride for all consumer and for most types of 15
commercial paint and coating removal uses,” and “to prohibit the use of 16
methylene c hloride for commercial paint and coating removal in [several] 17
specified sectors.” Id. at 7 , 465 . EPA did not propose to “regulate the use of 189 methylene chloride in commercial furniture refinishing . . . or refinishing 1
conducted by professionals or commercial workers , ” but noted that it 2
“intend[ed] to issue a separate proposal on methylene chloride in paint and 3
coating removal in commercial furni ture refinishing” and that it “plan[ned] to 4
issue one final rule covering both this proposal and the future proposed rule 5
on methylene chloride in paint and coating removal in commercial furniture 6
refinishing.” Id. Finally, the EPA proposed to require that any products 7
containing methylene chloride intended for paint removal be distributed in 8
containers not less than 55 gallons and to require certain downstream 9
notification requirements regarding the prohibition against manufacturing 10

and distribution. Id

. T hese notification requirements would apply only to 11

“ manufacturers . . . , processors, and distributors” and not “retailers ”; the 12
Proposed Rule defined “retailer” as “a person or business who distributes in 13

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

Id. at 7,526, 7 , 5 29

. 15
The Proposed Rule considered several regulatory alternatives to the 16

distributi on ban and container

- size restrictions : 1710 First , it considered whether the unreasonable risk could be eliminated 1
by warning labels ; it concluded that “[p]resenting information about 2
methylene chloride on a product label would not adequately address the 3

unre asonable risk

. . . because the nature of the information the user would 4
need to read, understand, and act upon is extremely complex.” Id. at 7 , 474. 5

T hough EPA “reason[ed] that revised labeling w[ould ] not address the 6
unreasonable risk presented by methylene chloride in paint and coating 7
removal,” it sought public comments on “enhanced labeling requirements for 8
consumer paint and coating removal products containing methylene 9

chloride” based on recommen dations from the Small Business Advocacy 10
Review (“SBAR”) Panel. Id. 11

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

but found that “[a]cute risks of incapacitation, coma, or death in workers 13
exposed to methylene chloride . . . are present even when respiratory 14
protection is used” “[i]n some industries with high exposure scenarios,” id. at 15

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

Third , EPA considered regulating consumer and commercial uses of 17
methylene chloride separately, but found that products containing methylene 1811 chloride “cannot be straightforwardly restricted to a single type of project or 1

user.” Id. at 7 , 479. 2

Fourth , EPA conduc ted a “limited evaluation” of a “training and 3
certification program for commercial paint and coating removers” as 4
recommended by the SBAR, but found that “effective risk reduction from 5
commercial use . . . would require additional regulation of distributor s of 6
these products ” to “ ensur[e] that only trained and certified commercial users 7
are able to access these paint and coating removal products , ” which the EPA 8
viewed “as a significant limitation for this approach.” Id. at 7 , 474. The EPA 9
sought public comme nt “on the feasibility of such a program.” Id. 10
EPA received tens of thousands of comments in response to the 2017 11
Proposed Rule ( many the result of mass

- mailing campaigns )

. A substantial 12
majority of those comments supported the P roposed R ule and determination 13
that the use of methylene chloride in both consumer and commercial paint 14
stripping posed an unreasonable risk of injury to health. EPA also received a 15

comment from the S BAR Panel, which recommended, as an alternative to a 16
distribution ban, a training and certification program for commercial uses of 17
products containing methylene chloride . The SBAR report included 1812 comments from Small Entity Representatives (“SERs”) claiming that EPA had 1
underestimated the cost of reformulating products containing methylene 2
chloride and that increased costs would cause small entities to go out of 3

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

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

available alternatives, reevaluate the costs to formulators, and eliminate the 6
restriction on the container size for these chemical products.” Joint App’x 720. 7
The Department of Defense submit ted comments urging EPA to adopt an 8
approach that would restrict access to methylene chloride by consumers 9
while still making it available in industrial settings. And in 2018, after the 10
comment period had ended, Petitioner HSIA submitted a white paper to t he 11
Small Business Administration recommending that EPA consider a training, 12
certification, and limited access program for commercial uses. 13
III. The Challenged Final Rule 14

On March 27, 2019 , EPA promulgated the final rule at issue in this 15
appeal. Methylene Chloride; Regulation of Paint and Coating Removal for 16
Consumer Use Under TSCA Section 6(a), 84 Fed. Reg. 11 , 420 (Mar. 27, 2019) 17
(hereafter “ Final Rule”). The Final Rule set forth a determination by EPA that 1813 “the use of methylene chloride in consu mer paint and coating removal 1
presents an unreasonable risk of injury to health due to acute human 2
lethality,” id. at 11,421 (emphasis added) ; on the other hand, it did not make a 3

final determination

— as it had proposed to do

— that commercial uses posed an 4
unreasonable risk. Instead, EPA published, on the same day, an Advanced 5
Notice of Proposed Rule Making (“ 2019 ANPRM”) “on questions related to a 6
potential training, certification, and limited access program as an option for 7
risk management for all of the commercial uses of methylene chloride in paint 8
and coating removal.” Id. ; see also Methylene Chloride; Commercial Paint and 9
Coating Removal Training, Certification and Limited Access Program, 84 Fed. 10
Reg. 11,466 (Mar. 27, 2019) (hereafter “2019 ANPRM”). 11

T o ensure that consumer uses of products containing methylene 12

chloride would “no longer present [] ” the identified unreasonable risk in 13
consumer products , the Final Rule prohibited the “manufacturing, processing 14
and distributing in commerce methylene chlorid e for consumer paint and 15
coating removal” and prohibited the distribution in commerce of methylene 16
chloride (or products containing it) both to and by “retailers.” 2019 Final Rule, 17
84 Fed. Reg. at 11,435. The Final Rule defined “retailer” as: 1814 a person who distributes in commerce or makes available a 1 chemical substance or mixture to consumer end users, including 2
e

- commerce internet sales or distribution. Any distributor with at 3 least one consumer end user customer is a considered a retailer. 4 A person who dis tributes in commerce or makes available a 5 chemical substance or mixture solely to commercial or industrial 6 end users or solely to commercial or industrial businesses is n ot 7 considered a retailer. 8
Id. 9
EPA considered and rejected a restriction on the distribution of 10
methylene chloride paint strippers in containers with a volume less than 55 11
gallons along with downstream notification requirements, which it 12
characterized as the “primary alternative regulat ory action.” Id. at 11,427. It 13
determined that the ban on sales to and by retailers was more cost effective 14

than the container

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

reduction . . . with estimated lower costs” than the container

- size re striction , 16
which would have caused costs to be “higher due to the cost of compliance 17
with the container volume requirements which impact commercial users not 18
targeted by the rule.” Id. 19

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

commerc ial uses of methylene chloride , nor did it determine that such uses 21
present an unreasonable risk of injury to health or the environment. Instead, it 2215 proposed in the 2019 ANPRM that a training and certification program, 1
combined with limited access by comme rcial users , “could allow access to 2
paint and coating removal products containing methylene chloride only to 3
commercial users who are certified as properly trained to engage in use 4
practices that do not present unreasonable risks.” 2019 ANPRM, 84 Fed. Reg. 5

at 11,466. Though the 2017 Proposed Rule had already sought comments on 6
such a program, EPA received only one responsive comment, from the 7
Environmental Defense Fund, which was sharply critical. Id. at 11,468. But, as 8
previously noted, in 2018, following the close of the comment period, HSIA 9
submitted a white paper advocating for such a training and certification 10

program. Id. EPA noted that such a program was similar to one used in the 11
United Kingdom, where acce ss to methylene chloride is restricted to certified 12
commercial end users, while unobtainable by consumer end users. Id. at 13

11,469. 14
On April 18, 2019, Environmental Petitioners filed their petition in this 15
court for review of the Final Rule. On May 24, 201 9, HSIA filed its petition for 16
review of the Final Rule in the D.C. Circuit, which granted EPA’s motion to 1716 transfer the petition to this court. On August 21, 2019, this court consolidated 1
the cases into this appeal. 2

DISCUSSION 3

I. The Toxic Substances Control Act (“TSCA”) and its Application to EPA’s 4 Evaluations and Regulations of Methylene Chloride 5 TSCA, originally enacted in 1976, was intended “to prevent 6
unreasonable risks of injury to health or the environment associated with the 7

manufac ture, processing, distribution in commerce, use, or disposal of 8
chemical substances.” S. Rep. No. 94

- 698, at 1 (1976), as reprinted in 1976 9

U.S.C.C.A.N. 4491 , and to give EPA “adequate authority . . . to regulate 10
chemical substances and mixtures which pres ent an unreasonable risk of 11
injury to health or the environment.” 15 U.S.C. § 2601(b)(2)

. 12
The nature of EPA’s duties and powers under TSCA has changed over 13

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

chemical risk evaluations, the initiation of which was within EPA’s discretion, 15
and the EPA had identified very few chemicals subject to § 2605(a)’s mandate

. 16
If chemicals were determined, prior to 2016, to present an unreasonable risk 17
of injury to health or the environment, TSCA required the EPA to regulate 18
them only to the extent necessary “to protect adequately against such risk” and 1917 in so regulating to use “ the least burdensome requirements , ” § 2605(a) (2012) 1
(emphasis added) (amended 2016) , w hich some courts interpreted to require 2

the EPA to balance the economic costs of proposed regulatory restrictions 3
against the environmental benefits those restrictions would provide , s ee, e.g. , 4
Corrosion Proof Fittings v. EPA , 947 F.2d 1201, 1215 (5th Cir. 1991). 5
The 2016 amendments to TSCA substantially increased EPA’s 6
obligation to evaluate and regulate dangerous chemicals. Instead of leaving 7
the complet ion of risk evaluations to EPA’s discretion, TSCA now require s 8

the EPA to conduct risk assessments for a minimum number of chemicals , 9
subject to statutory deadlines. 15 U.S.C. §§ 2605(b)(2)(A), (b)(1)(B)(i), (b)(4)(D). 10
It also prescribes detailed requirements for these chemical risk evaluations, 11
including that the determination whether a chemical presents an 12
unreasonable risk of injury to health or the environment shall be reached 13
“without consideration of costs or other nonrisk factors.” § 2605(b)(4)(A). And 14

it impose s statutory deadlines for regulation of a chemical found t o present 15
an unreasonable risk of injury to health or the envir onment under any of its 16

conditions of use . For such chemicals, the amended statute require s EPA to 17
propose a risk management rule within one year, and finalize that rule within 1818 two years , subject to a possible two

- year extension provided certain 1

conditions are met . § 2605(c)(1). 2

The amended statute also requires more stringent regulation of 3
chemicals identified as posing an unreasonable risk , replacing the previous 4
mandate “to protect adequately ” against identified unreasonable risks w ith 5
an obligation to regulate the substance “to the extent necessary so that [it] no 6
longer presents such risk.” Compare § 2605(a) (2012) (amended 2016) , with 7
§ 2605(a) (2018) (current) (emphasis added)

. And t he statute no longer 8
requires EPA to adopt the “least burdensome requirements” when regulating 9
chemicals that pose an unreasonable risk to health or the environment

. 10

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

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

must still “factor in, to the extent practicable,” several considerations , 13
including the “effects of the chemical . . . on the environment,” “the benefits 14
of the chemical . . . for various uses,” and “the reasonably ascertainable 15

economic consequences of the rule.” § 2605(c)(2) (A)

- (B) . The “factor[ing] in” 16
of reasonably ascertainable economic consequences includes consideration of 17
“the costs and benefits of the proposed and final regulatory actions and of the 1819 1 or more primary alternative r egulatory actions considered by the 1
Administrator.” § 2605(c)(2)(A)(iv). “[I]n deciding whether to prohibit or 2
restrict in a manner that substantially prevents a specific condition of use of a 3

chemical substance or mixture . . . [ EPA] shall consider, to th e extent 4
practicable, whether technically and economically feasible alternatives that 5
benefit health or the environment, compared to the use so proposed to be 6
prohibited or restricted, will be reasonably available as a substitute when the 7
proposed prohibit ion or other restriction takes effect

. ” § 2605(c)(2)(C). EPA’s 8
duty to consider costs, as contemplated by these statutory provisions, is 9
subject to the overall mandate to regulate the chemical to the extent that it “ no 10
longer presents ” the identified unrea sonable risk. § 2605(a). 11
Shortly prior to the 2016 amendment, EPA had completed risk 12
evaluations for several chemicals, including methylene chloride. TSCA’s 13
amendment addressed such “chemical substance[s] . . . for which the 14
Administrator has published a completed risk assessment prior to June 22, 15
2016.” § 2625( l )(4). Rather than requiring EPA to re

- complete risk assessments 16
for these chemicals, the 2016 amendment provide s that “the Administrator 17
may publish proposed and final rules under section 2605(a) of this title that 1820 are consistent with the scope of the completed risk assessment for the 1
chemical substance and consistent with other applicable requirements of 2

section 2605 of this title.” Id. 3

Because § 2625( l )(4) provide s that EPA “may” publish and propose 4
§ 2605(a) rules regarding chemicals for which EPA had already completed a 5

risk assessment, EPA’s decision, based on the 2014 Risk Assessment, 6
regarding whether to determine that consumer and commercial uses of 7
methylene chloride pose an unreasonable risk wa s not subject to the same 8
statutory deadlines as the same decision would be if based on a risk 9
evaluation completed after TSCA’s amendment. However, in 2016, EPA 10
designated methylene chloride as one of ten chemicals tha t would be the 11
subject of its required initial risk evaluation under the 2016 TSCA 12
amendment. After the 2019 Final Rule and ANPRM, EPA published a draft 13
risk evaluation for methylene chloride that included its use in commercial 14
paint and coating removal. T hat draft risk evaluation proposed to find that 15

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

Because this new risk evaluation

— unlike the 2014 Risk Assessment

— was 17
undertaken in compliance with the 2016 Amendment, it is subject to t he 1821 statutory deadlines requiring the risk evaluation to be finalized by June 2020. 1
§ 2605(b)(4)(G). On June 24, 2020, consistent with this statutory deadline, EPA 2

finalized this risk evaluation, determining that commercial use of methylene 3
chloride in pain t and coating removal presents an unreasonable risk of injury 4
to health. Methylene Chloride (MC); Final Toxic Substances Control Act 5
(TSCA) Risk Evaluation; Notice of Availability (“2020 Final Risk Evaluation”) , 6
85 Fed. Reg. 37,942 . Under § 2605(c)(1)(B), EPA must finalize a § 2605(a) risk 7
management rule regarding these identified commercial uses within two 8

years of the publication of the 2020 Final Risk Evaluation , subject to extension 9
under § 2605(c)(1)(C). 10

II. Standard of Review 11
For j udicial review of rules promulgated by EPA under § 2605(a), TSCA 12
provides a standard worded slightly differently from the standard established 13
by § 706 of the Administrative Procedure Act (“APA”) . The APA’s standard 14

of review provides that reviewing courts shall set aside agency action that is 15
“unsupported by substantial evidence.” 5 U.S.C. § 706(2)(E)

. “Substantial 16

evidence” under the APA has been understood to mean “such relevant 17
evidence as a reasonable mind might accept as adequate to support a 1822 conclusion.” Universal Camera Corp. v. NLRB , 340 U.S. 474, 477 (1951). Under 1
that standard, a court will not set aside an agency’s action so long as it is 2
“supported by less than a preponderance but more than a scintilla of 3

evidence.” Sprin t Spectrum L.P. v. Willoth , 176 F.3d 630, 638 (2d Cir. 1999) 4
(internal quotation marks omitted) . “Substantial evidence [under the APA] 5
requires ‘something less t han the weight of the evidence, and the possibility 6
of drawing two inconsistent conclusions from the evidence does not prevent 7
an administrative agency’s finding from being supported by substantial 8

evidence.’” Corrosion Proof , 947 F.2d at 1213 (quoting Con solo v. Federal 9

Maritime Comm’n , 383 U.S. 607, 620 (1966)). 10
In contrast, § 2618(c)(1)(B) of TSCA provides, “ [I]n the case of review 11

of

. . . a rule under section

. . . 2605(a) (including review of the associated 12
determination [of unreasonable risk]) , . . . the standard of review prescribed 13
by [ APA § 706(2)(E) ] shall not apply and the court shall hold unlawful and set 14

aside such rule if the court finds that the rule is no t supported by substantial 15
evidence in the rulemaking record taken as a whole.” 15 U.S.C. 16
§ 2618(c)(1)(B). 1723 Upon a straightforward reading of the text of these two provisions , it is 1

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

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

standard should be viewed as a distinct standard; otherwise there would 4
have been no need to specifically rule out the APA review standard.” Chem. 5
Mfrs. Ass’n v. EPA , 859 F.2d 977, 991 (D.C. Cir. 1988). Relying on TSCA’s 6
legislative history, that court held that TSCA’s substantial evidence standard 7
requires “more searching [review] than the judicial review undertaken in 8
most agency cases.” Id. at 992. The Third and Fift h Circuits have reached 9

similar conclusions. See Ausimont U.S.A. Inc. v. EPA , 838 F.2d 93, 96 (3d Cir. 10
1988); Shell Chemical Co. v. EPA , 826 F.2d 295, 297 (5th Cir. 1987). Those courts 11

have asserted that t he TSCA “substantial evidence” standard is a 12
“parti cularly demanding one , ” as compared to the arbitrary and capricious 13

standard

. Chem. Mfrs. , 859 F.2d at 992 (internal quotation marks omitted)

. We 14
agree with those c ircuits that TSCA’ s “substantial evidence” standard is more 1524 demanding on the agency than the standard of review otherwise prescribed 1
by the APA

. 1 2
While we agree with the D.C. Circuit that Congress’s emphasis on the 3
fact that the standard of TSCA differs from the APA standard surely means 4
that Congress intended th e two standards to be different, we find no need in 5

this case to reach a conclusion on the extent of the difference

. Whether EPA’s 6

F inal R ule is evaluated under a standard akin to APA’s substantial evidence 7

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

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 inc orrect” 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. , 745 F.2d 677, 683

- 85 (D .C. Cir. 1984) (“ ADPSCO ”). We find n either 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. , 859 F.2d at 991

. C ourts that have consid ered the question have rejected the survival of “arbitrary and capricious” review of TSCA rules, concluding instead that TSCA’s s ubstantial evidence standard is “particularly demanding

. ” See, e.g. , id. , 859 F.2d at 991 (“Congress perceived some difference between the standard it chose for TSCA and the APA’s arbitrary

- and

- capricious standard.”); see also Corrosion Proof , 947 F.2d at 1214 (“Congress put the substantial evidence test in the statute because it wanted the courts to scrutinize the Commission’s ac tions more closely than an ‘arbitrary and capricious’ standard would allow.” (internal quotation marks omitted)).25 adopted by other c ircuits, for the reasons described below, we conclude that 1
the Final Rule is adequately supported b y substantial evidence in the 2
rulemaking record taken as a whole, and should not be set aside. 3
III. HSIA’s Challenge to the 2019 Final Rule 4
HSIA challenges the 2019 Final Rule on four grounds . It argues: (1) the 5
prohibition of sales to and by retailers wa s inconsistent with the EPA’s intent 6
to allow commercial uses, because many commercial users purchase products 7
containing methylene chloride products through retailers; (2) EPA provided 8
insufficient notice and opportunity to comment on the definition of “r etailer” 9
in the final rule; (3) EPA’s assessment of the Final Rule’s impact on methylene 10
chloride product formulators was inadequate ; and (4) EPA lacked substantial 11
evidence to support its prohibition on distribution to and by retailers. We 12
reject HSIA’s a rguments

. 13
1. The prohibition on sales of methylene chloride products to and by retailers is 14 not inconsistent with EPA’s stated policy. 15
HSIA argues that the incidental effect on commercial users of the Final 16

Rule’s ban on sales to or by retailers is inconsistent with EPA’s stated policy 17
of allowing continued access to methylene chloride products by commercial 18

users. HSIA points out that retail outlets are a n important source of supply 1926 for commercial users that use only modest quantities of products containing 1
methylene chloride . HSIA further argues that the retailer ban is inconsistent 2
with EPA’s reasoning for rejecting the 55

- gallon minimum container 3

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

c ommercial users who typically purchase methylene chloride products in 5
smaller quantities

. 6

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

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

continued access to meth ylene chloride by commercial users. W hile it is true 9

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

neither did the Final Rule state or imply a policy encouraging , supporting , or 11
even approving the continuation of commercial uses. To the contrary, the 12
promulgation of the Final Rule in 2019 intentionally left open and under 13

consideration the question s whether and how to regulate commercial uses

. 14

E PA subsequently reached a determination that commer cial uses of 15
methylene chloride products present an unreasonable risk of injury to health , 16
triggering the statutory timeline for finalizing a § 2605(a) rule in the near 17

future. The Final Rule’s incidental effect on commercial users’ ability to access 1827 methylene chloride products could not be inconsistent with EPA’s policy of 1
allowing such access because the EPA had established no such policy. 2

Nor does the Final Rule prevent commercial users from obtaining 3
methylene chloride products, although it may c ause some commercial users 4

to seek different sources from those that they used in the past. EPA 5
considered this very possibility, noting that the Final Rule “potentially creates 6
a new marketspace for wholesalers and they may now sell these products to 7

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

alt hough currently “ [ w ] holesalers tend not to sell products in smaller 9
quantities, . . . with the change in the marketspace, [they] may choose to do so 10
if such an action would be profitab le.” Joint App’x 1023. EPA’s rejection of the 11

55

- gallon minimum container restriction, rather than being inconsistent with 12
its adoption of the retailer ban, supports the possibility of this evolving 13
marketspace by allowing continued wholesale distribution of methylene 14
chloride products in smaller units to replace the sales previously made by 15
retailers to commercial users of smaller quantities. 1628 2. The definition of retailer in the Final Rule was a “logical outgrowth” of the 1 Proposed Rule, and so gave sufficient notice and opportunity to comment. 2 HSIA contends that EPA provided insufficient notice and opportunity 3

to comment on the definition of “retailer” in the final rule. EPA was required 4
to provide notice of “either the terms or substance of the p roposed rule or a 5
description of the subjects and issues involved .” 5 U.S.C. § 553(b)(3) ( emphasis 6

added ) ; see 15 U.S.C. § 2605(c)(3) (noting that 5 U.S.C. § 553 applies to 7
§ 2605(a) rules). “ Courts of Appeals have generally interpreted th is to mean 8

that t he final rule the agency adopts must be a logical outgrowth of the rule 9
proposed.” Long Island Care at Home, Ltd. v. Coke , 551 U.S. 158, 174 (2007) 10
(internal quotation marks omitted) ; see also Nat’l Black Media Coal v. FCC , 791 11
F.2d 1016, 1022 (2d Cir. 1986)

. Accordingly, “ a final rule need not be an exact 12
replica of the rule proposed in the Notice , ” Nat’l Black Media , 791 F.2d at 1022, 13

a nd the standard is generally satisfied if the notice given by the agency fairly 14
apprises interested persons of the sub jects and issues that will be resolved by 15
the adoption of a final rule. See Riverkeeper, Inc. v. EPA , 475 F.3d 83, 113 (2d 16
Cir. 2007) , rev ’ d on other grounds sub nom. Entergy Corp. v. Riverkeeper, Inc. , 556 17
U.S. 208 (2009)

. We have explained that “ a n agency may modify a rule 18
through the notice

- and

- comment process so long as the agency’s modification 1929 is rational and ‘the agency’s path may reasonably be discerned.’” Co o ling 1

Water Intake Structure Coal. v. EPA , 905 F.3d 49, 71 ( 2d Cir. 2018) (quoting 2
Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm , 463 U.S. 29, 43 (1983) ). 3
TSCA additionally requires EPA to “publish a notice of proposed rulemaking 4
stating with particularity the reason for the proposed rule.” 15 U.S.C. 5
§ 2605(c)(3) (A)

. 6
HSIA argues (1) that EPA’s retailer ban is not a “logical outgrowth” of 7
the Proposed Rule because the retailer ban is inconsistent with the proposed 8

55

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

retailers, as well as with the Proposed Rule’s carveout for furniture 10
refinishers; and (2) that , given the change in te xt and purpose of the definition 11

of retailer as between the Proposed Rule and the Final Rule , EPA gave 12
inadequate notice. In support of this argument, HSIA contends that “despite 13
the enormous number of comments in the record, not a single commenter 14

address ed a ban on sales to or by retailers,” though some commenters 15
opposed bans on sales for commercial use. 16
We reject HSIA’s argument . We find that EPA satisfied the “logical 17
outgrowth” standard as we have interpreted it and complied with TSCA’s 1830 additional procedural requirements with respect to notice. EPA’s extensive 1
descriptions of the health risks posed by methylene chloride, which the Final 2
Rule seeks to eliminate in the consumer use context, plainly satisfied the 3
requirement that it “state with particularity the reason” for the proposed 4
regulation. The Proposed Rule made clear that the EPA was considering 5
prohibiting “the manufacture (includ ing import), processing, and distribution 6
in commerce of methylene chloride for consumer and most types of 7

commercial paint and coating removal

. ” 82 Fed. Reg. at 7,464. And the 8
Proposed Rule described the difficulty of entirely disentangling regulation of 9
consumer uses from regulation of commercial uses, given that “paint and 10
coating removal products containing methylene chloride frequently are 11
available in the same distribution channels to consumers and professional 12
users” and “cannot be straightforwardly restricted to a single type of project 13

or user.” Id. at 7,47 9 , 7, 505 . In other words, the Final Rule, which restricts 14
distribution of methylene chloride paint removal products only in commercial 15

channels that reach consumers , is considerably less restricti ve than the 16
regulation considered by the Proposed Rule, and its incidental impact on 17
commercial users reflects the difficulty of disentangling consumer and 1831 commercial uses described by the Proposed Rule. Indeed, commercial users 1

have considerably greater a ccess to methylene chloride products under the 2
Final Rule than they would have had under the regulation considered by the 3
Proposed Rule. 4
EPA gave notice that it was contemplating a rule that would drastically 5

reduce or even eliminate access to certain products containing methylene 6

chloride . The restriction ultimately adopted in the Final Rule was 7
considerably less extreme tha n the contemplated restriction announced in the 8
Proposed Rule. Interested parties had an opportunity to comment not only o n 9
the more extreme level of restriction that would have resulted from adoption 10
of the Proposed Rule, but also on less extreme restrictions the agency might 11

settle on within the s cope of the proposed restrictions announced. 12
Acceptance of HSIA’s concept of the notice and comment obligation 13
would substantially freeze EPA’s consideration of the Final Rule to an “all or 14
nothing” choice of adopting or categorically rejecting exactly what was 15
originally proposed. It would unreasonably encumber and delay agency 16

a ction , forcing t he agency to choose between ignoring commentary 17
suggesting useful modifications of proposed rules, or endlessly delaying 1832 action until submitted commentary and further study failed to suggest any 1
desirable modification. Such an interpretatio n of the notice and comment 2
requirement would seriously harm the ability of agencies to deal flexibly with 3
pressing problems. More importantly, such a n interpretation would be 4
plainly inconsistent with the statutory standard requiring that the “notice of 5
proposed rulemaking

. . . include . . . either the terms or substance of the 6
proposed rule or a description of the subjects and issues involved .” 5 U.S.C. 7
§ 553(b)(3). 8

W e conclude that EPA complied with its notice and comment 9
obligati ons and that the Final Rule was a logical outgrowth of its originally 10
noticed proposal. 11
3. EPA adequately considered costs to formulators of methylene chloride

. 12
HSIA next argues that EPA failed to consider adequately the impact of 13

the Final Rule on formulators of products containing methylene chloride. We 14
disagree. 15
EPA estimated that the cost resulting from the Final Rule to formulators 16
who would have to develop a new line of products not containing methylene 17

chloride would be approximately $27,000 annualized over two decades. This 1833 estimate was extrapolated from a survey addressing the manufacturing 1
marketspace for similar products in Canada, and an additional survey 2
regarding another chemical, trichloroethylene (also known as “ TCE”), which 3
EPA used to confirm the applicability for a U.S. rulemaking of the first 4
survey’s study of a Canadian market

. And EPA found that there are 5
“technically and economically feasible chemical substitutes or alternative 6

methods that are reasonabl y a vailable to a consumer for almost every 7

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

2019 Final Rule, 84 Fed. Reg. at 11,427

- 28. 9
HSIA argues that this evidence was insufficient to support EPA’s 10
determination regarding the costs to formulators resulting from the Final 11
Rule and that it was undermined by three comments submitted in response to 12

the P roposed R ule. First, HSIA claims that the American Chemistry Council 13
informed EPA that the surveys on which it relied were not valid because 14
“replacing methylene chloride is a substantially different undertaking from 15
replacing [TCE].” HSIA Br. 43. But HSIA’s citation in support of its assertion 16
points to a comment of the American Chemistry Council that says nothing of 17

the sort . The comment “ recommend s that EPA provide fuller discussion that 1834 explains why these [surveys] are appropriate to include in the costs 1

calculation , ” but does not assert that the surveys were inadequate. Joint 2
App’x 760. Second, HSIA points to a comment from a small business 3
formulator who stated that 40% of its revenue was derived from methylene 4
chloride products and that a 55

- gallon container restriction could result in the 5

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

of costs; under the Final Rule, the commenter is still able to formulate 7
methylene chloride products for distributors that exclusively serve 8

commercial users, to develop alternative products, and to continue packaging 9
its products in containers smaller than 55 gallons. Finally, HSIA relies on a 10
comment from the SBA claiming that product lines would “disappear” 11
because “there are no drop

- in replacements for methyle ne chloride.” Joint 12
App’x 718

- 19. But, again, formulators are not prevented from developing 13
methylene chloride products for distribution to commercial users or for uses 14
other than paint and coating removers, and the EPA found evidence that 15

alternatives are economically and technically feasible, as indicated in part by 16
many retailers that, e ven prior to being required to do so by the Final Rule, 1735 announced that they were voluntarily discontinuing the sale of methylene 1
chloride products. 2

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

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

because those comments are based on the faulty premise that formulators can 5
no longer manufacture methylene chloride products

— the Final Rule does not 6
prohibit manufacturing methylene chloride for commercial paint

- stripping 7

uses or for certain non

- paint

- stripping uses

. Record evidence rea sonably 8
supports the conclusion that EPA considered the reasonably ascertainable 9
consequences of the Final Rule on formulators , as well as EPA’s quantitative 10
and qualitative conclusions regarding those consequences

. In any event, 11
HSIA’s argument seems to a ssume that EPA is compelled to accept every 12

submitted comment as accurate and reconcile its ultimate rule to every such 13
comment. The requirement to produce a rule that is “ supported by 14
substantial evidence in the rulemaking record taken as a whole , ” 15 U.S .C. 15
§ 2618(c)(1)(B) , does not imp ose an obligation to reconcile the rule with every 16
comment submitted, much less to accept the validity of every such comment. 17

HSIA has failed to demonstrate that EPA’s estimation of the costs to 1836 formulators of methylene chl oride products is not supported by substantial 1

evidence. 2

4. EPA adequately considered the costs to retailers and distributors of 3 methylene chloride products. 4 Finally, HSIA argues that EPA failed to account adequately for the costs 5
to retailers of its prohibition of sales to and by retailers of methylene chloride 6
paint stripping products. It is true that costs to retailers were not estimated in 7

the EPA’s economi c analysis of the Final Rule

. EPA explained that this was 8

“ because the potential cost impact on retailers is uncertain ,” and that “co sts to 9
retailers were not estimated because of these uncertainties, and this may 10
represent a category of costs that are exc luded from the analysis.” Joint App’x 11

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

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

failed to consider adequately the costs of its retail ban on distr ibutors (who 14
would otherwise sell to retailers) and the cost to small commercial users from 15
the elimination of an important portion of their supply chain. The failure to 16
consider these costs, HSIA argues, was equivalent to EPA estimating the costs 17

to be ze ro. While HSIA acknowledges that the EPA need only rely on 18
“reasonably available information” and describe the “reasonably 1937 ascertainable economic consequences” of the Final Rule, 15 U.S.C. 1
§ 2605(c)(2)(A), it argues that EPA nonetheless cannot ignore a cost and that 2
EPA’s lack of information with respect to the retail ban’s costs was “its own 3
fault,” given the retail ban’s absence from the Proposed Rule , HSIA Br. at 52

- 4

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

would result from the 55

- gallon container size restriction, because adequate 6
notice was provided of that restriction , permitting commenters to provide 7

such information. 8
We disagree that the EPA’s inability to quantify the costs of the Final 9

Rule to retailers, distributors, and small commercial users means that it 10
ignored those costs. The record rather shows that EPA found the costs 11
impossible to estimate because of the likely growth of a new marketspace for 12

commercial

- only distribution and sales of alternative products . These 13
possibilities, the EPA reasoned, meant that the cost could potentially be 14

minimal, and that retailers “ could be better off under the rule” if profit 15
margins on altern ative products were higher. EPA Br. at 90 (collecting record 16
citations). For distributors , as previously discussed, supra 34

- 35 , EPA 17

considered

— though it could not quantify

— costs to commercial end users ; it 1838 found that these costs were not likely to be significant because of the 1
availability of technically and economically feasible substitutes. See 2019 Final 2
Rule, 84 Fed. Reg. at 11,427

- 28. These available substitutes mean that 3

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

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

access to a new marketspace in which wholesalers distribute directly to 6
commercial users to meet the demand previously met by retailers. 7

These qualitative assessment s of the costs to retailers, distributors, and 8

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

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

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

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

some lost business for these entities, it was also likely to create new business 13
via alternative products and an evolving marketspace. Far from ignoring 14
these potential consequences of the Final Rule, EPA considered them, 15
described them, and concluded that potential for new markets to replace the 16
losses initially caused by the Final Rule supported the rule’s implementation. 17
Reasonable minds might have reached a different conclusion from the 1839 evidence available to the EPA, but “the possibility of drawing two 1
inconsistent conclusions from the evidence does not prevent an 2
administrative agency’s finding from being supported by substantial 3

evidence.” C orrosion Proof , 947 F.2d at 1213 (quoting Consolo , 383 U.S. at 620). 4

* * * 5

In sum, having considered HSIA’s challenges to the Final Rule , we find 6
them unpersuasive. HSIA fails to demonstrate that EPA ’s prohibition on sales 7
to and by retailers was not a reasonable means, supported by substantial 8
evidence, to ensure that the unreasonable risks of methylene chloride paint 9
removal products for consumer uses be “no longer present[ed].” § 2605(a). 10

We therefor e deny HSIA’s petition to set aside the Final Rule

. 11
IV. Environmental Petitioners’ Challenge to the 2019 Final Rule 12

Environmental Petitioners contend the 2019 Final Rule was defective by 13

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

commercial paint and coating removal (as it determined for consumer uses) 15
“presents an unreasonable risk of injury to health or the environment,” 16

15 U.S.C. § 2605(a) , as well as (ii) its failure to impose specific regulations 17
governing commercial use so as to remove the unreasonable risk

. They 1840 advance a forceful argument that, given years of scientific data revealing 1
significant risks of severe adverse health consequences, it was inescapable 2

that the chemical poses an unreasonable risk in commercial applications, 3
particularly in view of the fact that commercial workers characteristically 4
experience far higher degrees of exposure than consumers. Environmental 5
Petitioners point to a history of statements by EPA, prior to its adoption of the 6

Final Rule in 2019, acknowledging the significant health risks posed by 7
commercial uses of methylene chloride and EPA’s corresponding statement of 8

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

both consumer and commercial uses. Environmental Petitioners also advance 10

the far more ambitious and less forceful argument that, in adopting the 2019 11
Final Rule, EPA was required by law not only to make a conclusive risk 12
evaluation but also to finalize regulations, either banning or controlling 13

commercial uses so that the risk would be “no longer pr esent[ed],” 15 U.S.C. 14
§ 2605(a)

. 15
EPA, in response, contends it made a reasonable decision to defer 16
reaching a determination for commercial uses pending further study of 17
possibilities of controlling risks in a commercial setting. It also advances 1841 several arguments that there should be no judicial review of its deliberations 1

on commercial uses until it reaches final determination s . Among those 2
arguments, it asserts that its consideration of commercial uses is prudentially 3
unripe for judicial review, as judi cial review at this time would involve 4
“judicial interference [before] an administrative decision has been formalized 5
and its effects felt in a concrete way by the challenging parties , ” Abbo t t Labs. v. 6

Gardner, 387 U.S. 136, 148

- 49 (1967) , without substantial alleviation of 7
hardship to the petitioners. EPA points out that it has not procrastinated, n or 8
ignored the significant risks arising from commercial use s of methylene 9

chloride

. It rather opted to begin with the easier task of developi ng a 10
regulatory scheme for consumer use s and then turn ing to the more complex 11

issue of how best to regulate commercial use s , as evidenced by its issuance of 12
the 2019 AMPRM upon the release of the 2019 Final Rule, and its Final Risk 13

Evaluation in 2020, in w hich it reached the very conclusion as to risk that 14
Environmental Petitioners contend it was required to reach in the 2019 Final 15

Rule : that commercial uses of methylene chloride in paint and coating 16
removal present an unreasonable risk of injury to health

. 1742 Notwithstanding the considerable force of Environmental Petitioners’ 1
focus on the dangerousness of methylene chloride , we agree with EPA that its 2

consideration of commercial use s is prudentially unripe for judicial review at 3

this time . The record supports EPA’s contention that judicial review at this 4
time would interfere in its consideration of the issue, would be no more likely 5

to advance than to hinder its arrival at a final determination, and, even 6
granting the relief Env ironmental Pet itioner s seek, would not necessarily 7
result in any reduction of harms from commercial use. Environmental 8

Petitioners have not shown that denial of the relief they now seek will subject 9
them to significant harms. 10
Under the doctrine of prudential ripene ss, courts will decline to review 11

administrative action that would otherwise be reviewable under 12
constitutional and statutory standards because, upon a balancing of the 13
pertinent interests, it is preferable for judicial review to await a more 14

advan c ed stat e of administrative consideration. The standards for invocation 15
of the prudential ripeness doctrine are generally described as a two

- prong 16

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

which requires consideration of “whether the court or the agency would 1843 benefit from postponing review until the policy in question has sufficiently 1
crystallized.” Fla. Power & Light Co. v. EPA , 145 F.3d 1414, 1421 (D.C. Cir. 2
1998) (internal quotation marks omitted) . The second prong

— the “hardshi p” 3

prong

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

decision is withheld .” NYCLU v. Grandeau , 528 F.3d 122, 134 (2d Cir. 2008)

. 5

The court must consider whether “the interests of the court and the agency in 6
postponing review outw eigh the interests of those seeking relief.” Nat’l Ass’n 7
of Regul

. Util. Comm’rs v. Dep’t of Energy , 851 F.2d 1424, 1428 (D.C. Cir. 1988). 8
These broad articulations of judicial discretion are not clearly defined, but 9

w hat is clear is the need for balancing of competing interests. 10
Considerations that favor invocation of the doctrine to defer judicial 11
review include the desirability of (i) avoiding involving courts in “abstract 12
disagreements over administrative policies ,” Abbott Labs. , 387 U.S. at 148 ; (ii) 13
preventing courts from exercising premature, unnecessary interference in 14
matters of governmental policy , see NYCLU v. Grandeau , 528 F.3d at 130

- 31 ; 15
and (iii) avoiding pernicious , unnecessary delay and obstruction of 16

a dministrative progress, particularly where the “possibility that further 1744 consideration [by the agency] will actually occur . . . is not theoretical, but 1

real,” Ohio Forestry Ass’n, Inc. v. Sierra Club , 523 U.S. 726, 735 (1998). 2
Considerations that weigh against deferring judicial review include 3
that (i) delaying judicial review can result in substantial harm to the interests 4
of those seeking review and (ii) judicial review can expedite successful 5
completion of the administrative task when an agency has embarked on a 6
route that does not comport with an obligatory legal framework. 7
Furthermore, the Supreme Court has recently noted “tension” between 8
exercise of prudential restraint and the Court’s “recent reaffirmation of the 9
principl e that a federal court ’s obligation to hear and decide cases within its 10
jurisdiction is virtually unflagging.” Lexmark Intern., Inc. v. Static Control 11
Components, Inc. , 572 U.S. 118, 126 (2014) (internal quotation marks omitted). 2 12
In general, the more the matter to be placed before the court involves a pure 13
issue of law, unaffected by factual considerations, the less the concern that 14
judicial review might interfere inappropriately with full, effective 15
administrative consideration or involve the court inapp ropriately in matters 16

2 T he Supreme Court has not “resolve[d] the continuing vitality of the prudential ripeness doctrine,” Susan B. Anthony List v. Driehaus , 5 73 U.S. 149, 167 (2014)

.45 of governmental policy. See NYCLU v. Grandeau , 528 F.3d at 132 (“[I]ssues 1
have been deemed [prudentially] ripe when they would not benefit from any 2
further factual development and when the court would be in no better 3
position to adjud icate the issues in the future than it is now. ” (internal 4
quotations marks omitted)) ; see also Gary D. Peake Excavating Inc. v. Town Bd. of 5

Hancock , 93 F.3d 68, 72 (2d Cir. 1996) (finding ripe claims that were “purely 6
legal and may be decided without furth er factual development”). 7
We conclude that Environmental Petitioners’ challenge to the Final 8

Rule

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

commercial uses

— is prudentially unripe for review at this time. On the day 10
of its promulgation of the Final Rule, on March 27, 2019, EPA published an 11
ANPRM indicating its intent to proceed to the question of how to deal with 12

commercial uses

. T hen, one year and three mont hs later, i n June 2020, it 13
finalized a risk assessment determining that commercial uses posed an 14
unreasonable risk. By making that determination, the agency imposed on 15
itself a statutory deadline to finalize a § 2605(a) rule within two years, (subject 16

to t he possibility of a two

- year extension if certain conditions are met). 17
§ 2605(c)(1). That record does not give substantial support to Environmental 1846 Petition er s’ argument t hat EPA’s failure to include commercial uses in the 1
Final Rule was procrastination de signed to postpone a resolution indefinitely. 2

Environmental Petition er s are undoubtedly correct that the agency’s record 3
on this question since it first recognized the adverse health risks of methylene 4

chloride is unimpressive. Nonetheless, however disincl ined the EPA may 5
have been in the past to deal with this difficult issue, its more recent record 6
does not support the conclusion that the agency’s deferral of the commercial 7
question in 2019 was a device to stall resolution indefinitely. It rather 8

supports the conclusion that EPA now recognizes its obligations and is 9
pursuing them. 10
Environmental Petitioners lean heavily on the hardship prong of the 11
test of prudential ripeness, asserting that adverse health consequences will 12

result from continued access to methylene chloride in commercial use. We 13
cannot deny the possibility that delaying regulation of methylene chloride in 14

commercial uses might produce some harm. Indeed, if the delay occasioned 15
by our reliance on prudential ripeness were open

- ended, Environ mental 16
Petitioners would have a stronger argument against application of that 17

doctrine . The delay, however, is not open ended. In fact, given the steps EPA 1847 has already taken, Environmental Petitioners have not successfully shown 1
that granting the relief so ught would either bring about an earlier final 2
regulation or significantly reduce harms. Given that the deadline EPA has 3

taken on by finalizing the 2020 Final Risk Evaluation is rapidly approaching , 4
the harm resulting from EP A ’s postponement of the risk assessment for 5
commercial use until after dealing with consumer use is not enormous. E ven 6
assuming that the risk of harm to commercial users might have been slightly 7

reduced had EPA determined that those uses pose an unreasonabl e health 8

risk and regulated them when it passed the Final Rule in 2019, it does not 9
necessarily follow that future harms would be reduced by now granting the 10
relief that petitioners seek. G ranting that relief at this time could as easily 11

have the effect of delaying the ultimate resolution and increasing the harms , 12
rather than reducing them. C ourt

- imposed pressure to reach a final scheme of 13
regulation before the agency has adequately collected and studied the needed 14

information could cause the agency to reac h an inadequate solution that fails 15
to protect against harms as effectively as EPA might have protected if given 16

sufficient time. Moreover, e ven if we were to order EPA to revise the 17
challenged Final Rule to adopt regulations restricting commercial uses, E PA 1848 would still need to consider a variety of regulatory options, the comparative 1
effectiveness of those options in ensuring that unreasonable risks are no 2
longer presented, and the reasonably ascertainable economic consequences of 3
those potential regulatio ns . As a result, it is unlikely that EPA could comply 4
with our order before the expiration of the deadline EPA has already imposed 5
on itself by publishing the 2020 Final Risk Evaluation. 6

Nor do we think Environmental Petitioners are correct in arguing that 7
the issue before the court is a pure question of law, such as disfavors 8
application of the doctrine of prudential ripeness. While judicial review 9
inevitably raises questions of law, the questions whether commercial use of 10
methy lene chloride presents an unreasonable risk of harm ; if so, how that risk 11

of harm should be neutralized; and whether EPA’s decision to delay 12
answering that question until after producing a final rule on consumer uses 13

was arb i trary , unreasonable , or not sup ported by substantial evidence are 14
very much dependent on factual considerations . It is not as if the issue in 15
dispute simply involve d the interpretation of a statutory term or the 16
application of law to undisputed facts. 1749 The deadline for a final risk man agement rule regarding commercial 1
uses of methylene chloride is rapidly approaching. We conclude that the 2
extent to which TSCA requires EPA to regulate commercial uses of methylene 3
chloride, and whether the rules EPA promulgates adequately do so, will be a 4
better fit for judicial review after that rulemaking process is complete and the 5
“policy in question has sufficiently crystallized.” Fla. Power & Light , 145 F.3d 6

at 1421 (internal quotation marks omitted) . Judicial review at this time, in the 7

absence of a record that fully considered regulation of commercial uses, might 8
force the court to cope with abstract disagreements and involve itself in 9
matters of administrative policy without the benefit of illuminating 10

information. See Abbott Labs. , 387 U.S. at 148

- 49 (1967). 11
Accordingly, we hold that Environmental Petitioners’ challenge s to the 12

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

for review are DENIED

. 14

CONCLUSION 15
For the foregoing reasons, the petitions for review of the 2019 Final 16

Rule are DENIED. 17