FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

SAFER CHEMICALS, HEALTHY 

FAMILIES; ALASKA COMMUNITY 

ACTION ON TOXICS;

ENVIRONMENTAL HEALTH STRATEGY 

CENTER; ENVIRONMENTAL WORKING 

GROUP; LEARNING DISABILITIES 

ASSOCIATION OF AMERICA; SIERRA 

CLUB; UNION OF CONCERNED 

SCIENTISTS; UNITED STEEL, PAPER 

AND FORESTRY, RUBBER,

MANUFACTURING, ENERGY, ALLIED 

INDUSTRIAL AND SERVICE WORKERS 

INTERNATIONAL UNION, AFLCIO/CLC; WE ACT FOR 

ENVIRONMENTAL JUSTICE; ASBESTOS 

DISEASE AWARENESS 

ORGANIZATION; VERMONT PUBLIC 

INTEREST RESEARCH GROUP,

Petitioners,

v.

U.S. ENVIRONMENTAL PROTECTION 

AGENCY; ANDREW WHEELER,

*

No. 17-72260

* Andrew Wheeler has been substituted for his predecessor, Scott 

Pruitt, under Fed. R. App. P. 43(c)(2).
2 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

Administrator, United States 

Environmental Protection Agency,

Respondents,

AMERICAN CHEMISTRY COUNCIL;

AMERICAN COATINGS ASSOCIATION;

AMERICAN COKE AND COAL 

CHEMICALS INSTITUTE; AMERICAN 

FOREST & PAPER ASSOCIATION;

AMERICAN FUEL & PETROCHEMICAL 

MANUFACTURERS; AMERICAN 

PETROLEUM INSTITUTE; BATTERY 

COUNCIL INTERNATIONAL; CHAMBER 

OF COMMERCE OF THE UNITED 

STATES OF AMERICA; EPS INDUSTRY 

ALLIANCE; IPC INTERNATIONAL,

INC., doing business as IPC 

Association Connecting Electronics 

Industries; NATIONAL ASSOCIATION 

OF CHEMICAL DISTRIBUTORS;

NATIONAL MINING ASSOCIATION;

POLYURETHANE MANUFACTURERS 

ASSOCIATION; SILVER 

NANOTECHNOLOGY WORKING 

GROUP; SOCIETY OF CHEMICAL 

MANUFACTURERS AND AFFILIATES;

STYRENE INFORMATION AND 

RESEARCH CENTER; UTILITY SOLID 

WASTE ACTIVITIES GROUP,

Respondents-Intervenors.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 3

ENVIRONMENTAL DEFENSE FUND,

Petitioner,

v.

U.S. ENVIRONMENTAL PROTECTION 

AGENCY; ANDREW WHEELER, 

Administrator, United States 

Environmental Protection Agency,

Respondents,

AMERICAN CHEMISTRY COUNCIL;

AMERICAN COATINGS ASSOCIATION;

AMERICAN COKE AND COAL 

CHEMICALS INSTITUTE; AMERICAN 

FOREST & PAPER ASSOCIATION;

AMERICAN FUEL & PETROCHEMICAL 

MANUFACTURERS; AMERICAN 

PETROLEUM INSTITUTE; BATTERY 

COUNCIL INTERNATIONAL; CHAMBER 

OF COMMERCE OF THE UNITED 

STATES OF AMERICA; EPS INDUSTRY 

ALLIANCE; IPC INTERNATIONAL,

INC., doing business as IPC 

Association Connecting Electronics 

Industries; NATIONAL ASSOCIATION 

OF CHEMICAL DISTRIBUTORS;

NATIONAL MINING ASSOCIATION;

POLYURETHANE MANUFACTURERS 

ASSOCIATION; SILVER 

NANOTECHNOLOGY WORKING 

GROUP; SOCIETY OF CHEMICAL 

MANUFACTURERS AND AFFILIATES;

STYRENE INFORMATION AND 

No. 17-72501
4 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

RESEARCH CENTER; UTILITY SOLID 

WASTE ACTIVITIES GROUP,

Respondents-Intervenors.

ALLIANCE OF NURSES FOR HEALTHY 

ENVIRONMENTS; CAPE FEAR RIVER 

WATCH; NATURAL RESOURCES 

DEFENSE COUNCIL,

Petitioners,

v.

U.S. ENVIRONMENTAL PROTECTION 

AGENCY,

Respondent,

AMERICAN CHEMISTRY COUNCIL;

AMERICAN COATINGS ASSOCIATION;

AMERICAN COKE AND COAL 

CHEMICALS INSTITUTE; AMERICAN 

FOREST & PAPER ASSOCIATION;

AMERICAN FUEL & PETROCHEMICAL 

MANUFACTURERS; AMERICAN 

PETROLEUM INSTITUTE; BATTERY 

COUNCIL INTERNATIONAL; CHAMBER 

OF COMMERCE OF THE UNITED 

STATES OF AMERICA; EPS INDUSTRY 

ALLIANCE; IPC INTERNATIONAL,

INC., doing business as IPC 

Association Connecting Electronics 

Industries; NATIONAL ASSOCIATION 

OF CHEMICAL DISTRIBUTORS;

NATIONAL MINING ASSOCIATION;

No. 17-72968

EPA No.

EPA-HQ-OPPT2016-0636
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 5

POLYURETHANE MANUFACTURERS 

ASSOCIATION; SILVER 

NANOTECHNOLOGY WORKING 

GROUP; SOCIETY OF CHEMICAL 

MANUFACTURERS AND AFFILIATES;

STYRENE INFORMATION AND 

RESEARCH CENTER; UTILITY SOLID 

WASTE ACTIVITIES GROUP,

Respondents-Intervenors.

ALLIANCE OF NURSES FOR HEALTHY 

ENVIRONMENTS; CAPE FEAR RIVER 

WATCH; NATURAL RESOURCES 

DEFENSE COUNCIL,

Petitioners,

v.

U.S. ENVIRONMENTAL PROTECTION 

AGENCY,

Respondent,

AMERICAN CHEMISTRY COUNCIL;

AMERICAN COATINGS ASSOCIATION;

AMERICAN COKE AND COAL 

CHEMICALS INSTITUTE; AMERICAN 

FOREST & PAPER ASSOCIATION;

AMERICAN FUEL & PETROCHEMICAL 

MANUFACTURERS; AMERICAN 

PETROLEUM INSTITUTE; BATTERY 

COUNCIL INTERNATIONAL; CHAMBER 

OF COMMERCE OF THE UNITED 

STATES OF AMERICA; EPS INDUSTRY 

No. 17-73290

EPA No.

EPA-HQ-OPPT2016-0654
6 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

ALLIANCE; IPC INTERNATIONAL,

INC., doing business as IPC 

Association Connecting Electronics 

Industries; NATIONAL ASSOCIATION 

OF CHEMICAL DISTRIBUTORS;

NATIONAL MINING ASSOCIATION;

POLYURETHANE MANUFACTURERS 

ASSOCIATION; SILVER 

NANOTECHNOLOGY WORKING 

GROUP; SOCIETY OF CHEMICAL 

MANUFACTURERS AND AFFILIATES;

STYRENE INFORMATION AND 

RESEARCH CENTER; UTILITY SOLID 

WASTE ACTIVITIES GROUP,

Respondents-Intervenors.

ENVIRONMENTAL DEFENSE FUND,

Petitioner,

v.

U.S. ENVIRONMENTAL PROTECTION 

AGENCY; ANDREW WHEELER, 

Administrator, United States 

Environmental Protection Agency,

Respondents,

AMERICAN CHEMISTRY COUNCIL;

AMERICAN COATINGS ASSOCIATION;

AMERICAN COKE AND COAL 

CHEMICALS INSTITUTE; AMERICAN 

FOREST & PAPER ASSOCIATION;

AMERICAN FUEL & PETROCHEMICAL 

No. 17-73383

EPA No.

EPA-HQ-OPPT2016-0654
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 7

MANUFACTURERS; AMERICAN 

PETROLEUM INSTITUTE; BATTERY 

COUNCIL INTERNATIONAL; CHAMBER 

OF COMMERCE OF THE UNITED 

STATES OF AMERICA; EPS INDUSTRY 

ALLIANCE; IPC INTERNATIONAL,

INC., doing business as IPC 

Association Connecting Electronics 

Industries; NATIONAL ASSOCIATION 

OF CHEMICAL DISTRIBUTORS;

NATIONAL MINING ASSOCIATION;

POLYURETHANE MANUFACTURERS 

ASSOCIATION; SILVER 

NANOTECHNOLOGY WORKING 

GROUP; SOCIETY OF CHEMICAL 

MANUFACTURERS AND AFFILIATES;

STYRENE INFORMATION AND 

RESEARCH CENTER; UTILITY SOLID 

WASTE ACTIVITIES GROUP,

Respondents-Intervenors.

SAFER CHEMICALS, HEALTHY 

FAMILIES; ALASKA COMMUNITY 

ACTION ON TOXICS;

ENVIRONMENTAL HEALTH STRATEGY 

CENTER; ENVIRONMENTAL WORKING 

GROUP; LEARNING DISABILITIES 

ASSOCIATION OF AMERICA; SIERRA 

CLUB; UNION OF CONCERNED 

SCIENTISTS; UNITED STEEL, PAPER 

AND FORESTRY, RUBBER,

MANUFACTURING, ENERGY, ALLIED 

INDUSTRIAL AND SERVICE WORKERS 

No. 17-73390

EPA No.

EPA-HQ-OPPT2016-0654
8 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

INTERNATIONAL UNION, AFLCIO/CLC; WE ACT FOR 

ENVIRONMENTAL JUSTICE; ASBESTOS 

DISEASE AWARENESS 

ORGANIZATION; VERMONT PUBLIC 

INTEREST RESEARCH GROUP,

Petitioners,

v.

U.S. ENVIRONMENTAL PROTECTION 

AGENCY; ANDREW WHEELER, 

Administrator, United States 

Environmental Protection Agency,

Respondents,

AMERICAN CHEMISTRY COUNCIL;

AMERICAN COATINGS ASSOCIATION;

AMERICAN COKE AND COAL 

CHEMICALS INSTITUTE; AMERICAN 

FOREST & PAPER ASSOCIATION;

AMERICAN FUEL & PETROCHEMICAL 

MANUFACTURERS; AMERICAN 

PETROLEUM INSTITUTE; BATTERY 

COUNCIL INTERNATIONAL; CHAMBER 

OF COMMERCE OF THE UNITED 

STATES OF AMERICA; EPS INDUSTRY 

ALLIANCE; IPC INTERNATIONAL,

INC., doing business as IPC 

Association Connecting Electronics 

Industries; NATIONAL ASSOCIATION 

OF CHEMICAL DISTRIBUTORS;

NATIONAL MINING ASSOCIATION;

POLYURETHANE MANUFACTURERS 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 9

ASSOCIATION; SILVER 

NANOTECHNOLOGY WORKING 

GROUP; SOCIETY OF CHEMICAL 

MANUFACTURERS AND AFFILIATES;

STYRENE INFORMATION AND 

RESEARCH CENTER; UTILITY SOLID 

WASTE ACTIVITIES GROUP,

Respondents-Intervenors.

On Petition for Review of an Order of the

Environmental Protection Agency

Argued and Submitted May 16, 2019

Seattle, Washington

Filed November 14, 2019

Before: Diarmuid F. O’Scannlain and Michelle T. 

Friedland, Circuit Judges, and William H. Pauley III,**

District Judge.

Opinion by Judge Friedland

** The Honorable William H. Pauley III, United States District Judge 

for the Southern District of New York, sitting by designation.
10 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

SUMMARY***

Environmental Law

The panel dismissed in part, granted in part, and denied 

in part petitions for review brought by a variety of 

environmental groups and other organizations, seeking 

review of a rule promulgated by the United States 

Environmental Protection Agency (“EPA”) establishing a 

process to evaluate the health and environmental risks of 

chemical substances.

The EPA promulgated the Risk Evaluation Rule 

pursuant to the Toxic Substances Control Act (“TSCA”).

Petitioners argued that TSCA required EPA to evaluate 

risks from uses of a chemical substance collectively, and that 

the Risk Evaluation Rule contradicted this mandate. The 

panel held that this challenge was not justiciable because 

petitioners’ interpretation of what the EPA intended to do 

and petitioners’ resulting theory of injury were too 

speculative. The panel further held that because petitioners’ 

theory of injury was dependent upon harm caused by a 

failure to assess all conditions of use together, and because 

it was very uncertain whether EPA ever planned to do what 

petitioners feared, petitioners’ alleged injury was too 

speculative at this time to establish Article III jurisdiction.

Petitioners also argued that the Risk Evaluation Rule 

expressed an impermissible intent to exclude some 

*** This summary constitutes no part of the opinion of the court. It 

has been prepared by court staff for the convenience of the reader.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 11

conditions of use from the scope of a risk evaluation, thereby 

contravening TSCA’s requirement that EPA consider all of 

a chemical’s conditions of use. With respect to petitioners’ 

challenge to language in the preamble to the Risk Evaluation 

Rule, the panel held that it was not final agency action, and 

thus not reviewable under the Administrative Procedure Act. 

With respect to petitioners’ challenges to specific provisions 

of the Risk Evaluation Rule, the panel held that the 

challenges were justiciable final agency action. The panel 

further held that petitioners had standing to challenge these 

provisions, and that the challenge was ripe. The panel 

concluded that the Rule’s scope provisions failed on the 

merits because the challenged provisions did not in fact 

assert discretion to exclude conditions of use from 

evaluation.

Finally, petitioners challenged EPA’s categorical 

exclusion of legacy activities from the definition of 

“conditions of use.” The panel held that this claim was 

justiciable. Turning to the merits, the panel held that EPA’s 

exclusion of legacy uses and associated disposals 

contradicted TSCA’s plain language, but that EPA’s 

exclusion of legacy disposals did not.

COUNSEL

Sarah C. Tallman (argued), Natural Resources Defense 

Council, Chicago, Illinois; Nancy S. Marks, Natural 

Resources Defense Council, New York, New York; for 

Petitioners Alliance of Nurses for Healthy Environments; 

Cape Fear River Watch; and Natural Resources Defense 

Council.
12 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

Robert M. Sussman, Sussman and Associates, Washington, 

D.C.; for Petitioners Safer Chemicals, Healthy Families; 

Asbestos Disease Awareness Organization; and Vermont 

Public Interest Research Group.

Robert P. Stockman, Environmental Defense Fund, 

Washington, D.C.; for Petitioner Environmental Defense 

Fund.

Eve C. Gartner, Earthjustice, New York, New York; Tosh 

Sagar, Earthjustice, Washington, D.C.; for Petitioners 

Alaska Community Action on Toxics; Environmental 

Health Strategy Center; Environmental Working Group; 

Learning Disabilities Association of America; Sierra Club; 

Union of Concerned Scientists; and WE ACT for 

Environmental Justice.

Randy S. Rabinowitz, OSH Law Project LLC, Washington 

D.C.; for Petitioner United Steel, Paper and Forestry, 

Rubber, Manufacturing, Energy, Allied Industrial and 

Service Workers International Union, AFL-CIO/CLC.

Samara M. Spence (argued) and Erica M. Zilioli, 

Environmental Defense Section, Environment and Natural 

Resources Division, United States Department of Justice, 

Washington, D.C.; Jonathan D. Brightbill, Deputy Assistant 

Attorney General; Jeffrey H. Wood, Acting Assistant 

Attorney General; Laurel Celeste, Office of the General 

Counsel, United States Environmental Protection Agency, 

Washington, D.C.; for Respondents.

Peter D. Keisler (argued), Samuel B. Boxerman, Timothy K. 

Webster, C. Frederick Beckner III, Judah Prero, and Samina 

M. Bharmal, Sidley Austin LLP, Washington, D.C.; for 

Respondents-Intervenors American Chemistry Council; 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 13

American Coke and Coal Chemicals Institute; American 

Petroleum Institute; American Forest & Paper Association; 

American Fuel & Petrochemical Manufacturers; Chamber of 

Commerce of the United States Of America; EPS Industry 

Alliance; IPC International, Inc.; National Association of 

Chemical Distributors; National Mining Association; and 

Silver Nanotechnology Working Group.

David B. Weinberg, Martha E. Marrapese, and Roger H. 

Miksad, Wiley Rein LLP, Washington, D.C.; for 

Respondents-Intervenors American Coatings Association 

and Battery Council International.

Donald P. Gallo, Axley Brynelson LLP, Waukesha, 

Wisconsin; for Respondent-Intervenor Polyurethane 

Manufacturers Association.

James W. Conrad, Jr., Conrad Law & Policy Counsel, 

Washington, D.C.; for Respondent-Intervenor Society of 

Chemical Manufacturers and Affiliates.

Peter L. de la Cruz, Keller and Heckman LLP, Washington, 

D.C.; for Respondent-Intervenor Styrene Information and 

Research Center, Inc.

Douglas H. Green and Allison D. Foley, Venable LLP, 

Washington, D.C.; for Respondent-Intervenor Utility Solid 

Waste Activities Group.

Richard Moskowitz and Taylor Hoverman, American Fuel 

& Petrochemical Manufacturers, Washington, D.C.; for 

Respondent-Intervenor American Fuel & Petrochemical 

Manufacturers.
14 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

Steven P. Lehotsky and Michael B. Schon, U.S. Chamber 

Litigation Center, Washington, D.C.; for RespondentIntervenor Chamber of Commerce of the United States of 

America.

David S. Muraskin and Leah M. Nicholls, Public Justice 

P.C., Washington, D.C.; for Amici Curiae American 

Academy of Pediatrics, the American College of 

Obstetricians and Gynecologists, and the American Public 

Health Association.

Paul Olszowka, Barnes & Thornburg LLP, Chicago, Illinois; 

for Amicus Curiae People for the Ethical Treatment of 

Animals.

OPINION

FRIEDLAND, Circuit Judge:

Petitioners, a variety of environmental groups and other 

organizations, seek review of a rule promulgated by the 

United States Environmental Protection Agency (“EPA” or 

“the Agency”) establishing a process to evaluate the health 

and environmental risks of chemical substances. EPA 

promulgated the “Risk Evaluation Rule” under its authority 

granted by 15 U.S.C. § 2605(b)(4)(B), a provision added in 

2016 to the Toxic Substances Control Act (“TSCA”), 

15 U.S.C. § 2601 et seq.1 Petitioners argue that provisions 

in the Risk Evaluation Rule relating to the Agency’s 

evaluation of the risks from a substance’s “conditions of 

1 Unless otherwise specified, all references to TSCA’s provisions in 

title 15 of the United States Code are to the current version, which was 

amended in 2016.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 15

use” violate several of TSCA’s requirements. Specifically, 

Petitioners argue: (1) that TSCA requires EPA to evaluate 

risks associated with a chemical’s uses collectively before 

determining that the chemical is safe; (2) that EPA must 

consider all of a chemical’s conditions of use in that 

evaluation; and (3) that, when considering conditions of use, 

EPA must evaluate past disposals of all chemicals, as well 

as the use and subsequent disposal of chemicals not currently 

or prospectively manufactured or distributed in commerce 

for that use. Petitioners argue that various provisions of the 

Risk Evaluation Rule demonstrate that EPA will not do any 

of these three things.2

We hold that we lack jurisdiction to review Petitioners’ 

first challenge, and that their second fails on the merits. But 

we grant in part the Petition for Review with respect to 

Petitioners’ third challenge.3

2 Petitioners also argue that EPA’s simultaneously promulgated 

“Prioritization Rule” incorporates some of these alleged deficiencies in 

the Risk Evaluation Rule, and that the provisions doing so are likewise 

unlawful. Because Petitioners’ challenges to the Prioritization Rule are 

entirely encompassed within their challenges to the Risk Evaluation 

Rule, the challenges rise or fall together. We thus focus only on the Risk 

Evaluation Rule.

3 Petitioners also challenge several information-gathering provisions 

in both the Risk Evaluation Rule and the Prioritization Rule. See 

15 U.S.C. § 2625(k). EPA agrees that some of these challenged 

information-gathering provisions should be reconsidered and therefore 

requests that they be remanded. We address the information-gathering 

issues in a concurrently filed memorandum disposition.
16 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

I.

A.

Congress enacted TSCA in 1976 “to prevent 

unreasonable risks of injury to health or the environment 

associated with the manufacture, processing, distribution in 

commerce, use, or disposal of chemical substances.” S. Rep. 

No. 94-698, at 1 (1976), as reprinted in 1976 U.S.C.C.A.N. 

4491, 4491. TSCA was “designed to fill a number of 

regulatory gaps” in premarket review, regulation of 

chemicals themselves (rather than regulation of discharges, 

emissions, ambient air, or consumer products), and 

information-gathering responsibility. Id. at 1–2. TSCA 

required EPA to regulate chemical substances that the 

Agency found to “present an unreasonable risk of injury to 

health or the environment.” 15 U.S.C. § 2605(a) (1976). As 

originally enacted, however, TSCA did not provide a 

specific process or timeline by which EPA was required to 

evaluate a substance’s risks.

In the decades following TSCA’s passage, Congress 

found that “effective implementation of TSCA by [EPA] 

ha[d] been challenged by shortcomings in the statute itself, 

and by several key decisions of Federal Courts and the 

Agency’s interpretation of those decisions.” S. Rep. No. 

114-67, at 2 (2015). There had “been persistent concerns 

about the pace of EPA’s work under TSCA, the ability of the 

Agency to use its existing authority, and whether the statute 

prevent[ed] certain regulatory efforts.” H.R. Rep. No. 114-

176, at 12–13 (2015), as reprinted in 2016 U.S.C.C.A.N. 

276, 277. Congress accordingly amended TSCA in 2016. 

See Frank R. Lautenberg Chemical Safety for the 21st 

Century Act, Pub. L. No. 114-182, 130 Stat. 448 (2016) 

(codified at 15 U.S.C. § 2601 et seq.); see also generally S. 

Rep. No. 114-67; H.R. Rep. No. 114-176.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 17

The 2016 amendments “restructur[ed] the way . . . 

chemicals are evaluated and regulated,” H.R. Rep. No. 114-

176, at 13, but Congress’s policy goals reflected in the 1976 

Act remained “intact,” S. Rep. No. 114-67, at 7. Congress 

intended through the amendments “to provide broad 

protection of human health and the environment,” and “to 

improve availability of information about chemicals.” S. 

Rep. No. 114-67, at 6.

B.

The 2016 amendments create, among other things, “a 

separate risk evaluation process for determining whether a 

chemical substance presents or will present an unreasonable 

risk of injury,” and prescribe statutory deadlines by which 

EPA is required to complete such evaluations. H.R. Rep. 

No. 114-176, at 23, 25. The amendments also direct EPA’s 

Administrator to prioritize evaluations of the risks of 

chemicals considered to be the most dangerous. And once 

EPA determines that a particular chemical substance is 

associated with an unreasonable risk, the Agency is required 

to regulate that substance.

With respect to prioritizing risk evaluations, TSCA 

requires that the Administrator “designate as a high-priority 

substance a chemical substance that the Administrator 

concludes . . . may present an unreasonable risk of injury to 

health or the environment . . . under the conditions of use.” 

15 U.S.C. § 2605(b)(1)(B)(i). The Administrator must 

designate a substance as “low-priority” if “such substance 

does not meet the standard” to be high-priority. 15 U.S.C. 

§ 2605(b)(1)(B)(ii).

For chemical substances that EPA designates as highpriority, the Agency must initiate and complete a risk 

evaluation of the chemical within three years, with a possible 
18 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

six-month extension. 15 U.S.C. § 2605(b)(3)(A), (b)(4)(G). 

EPA must also conduct some risk evaluations at the request 

of chemical manufacturers (“manufacturer-requested risk 

evaluations”). See 15 U.S.C. § 2605(b)(4)(C)(ii).

TSCA’s risk evaluation provision requires EPA to 

evaluate chemical substances under their “conditions of 

use.” Specifically, TSCA states:

The Administrator shall conduct risk 

evaluations pursuant to this paragraph to 

determine whether a chemical substance 

presents an unreasonable risk of injury to 

health or the environment, without 

consideration of costs or other nonrisk 

factors, including an unreasonable risk to a 

potentially exposed or susceptible 

subpopulation identified as relevant to the 

risk evaluation by the Administrator, under 

the conditions of use.

15 U.S.C. § 2605(b)(4)(A).

The term “conditions of use” is defined to mean “the 

circumstances, as determined by the Administrator, under 

which a chemical substance is intended, known, or 

reasonably foreseen to be manufactured, processed, 

distributed in commerce, used, or disposed of.” 15 U.S.C. 

§ 2602(4).4 In the early stages of the risk evaluation process, 

TSCA requires EPA to list in a published scope document 

4 TSCA provides statutory definitions for the terms “manufacture,” 

“process,” and “commerce” (as well as “distribute in commerce” and 

“distribution in commerce”), but does not define “used” or “disposed 

of.” See generally 15 U.S.C. § 2602.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 19

the conditions of use it “expects to consider” for the 

chemical substance being evaluated. 15 U.S.C. 

§ 2605(b)(4)(D).

Once a risk evaluation is completed, if the Administrator 

determines based on that evaluation “that the manufacture, 

processing, distribution in commerce, use, or disposal of a 

chemical substance or mixture, or that any combination of 

such activities, presents an unreasonable risk of injury to 

health or the environment, the Administrator shall” 

promulgate rules regulating that chemical substance so that 

it “no longer presents such [an unreasonable] risk.” 

15 U.S.C. § 2605(a); see also 15 U.S.C. § 2605(c)(1).

In order to effectuate TSCA’s statutory requirements, 

Congress instructed EPA to “establish, by rule, a risk-based 

screening process, including criteria for designating 

chemical substances as” either high-priority or low-priority 

for risk evaluation. 15 U.S.C. § 2605(b)(1)(A). EPA was 

also required to establish by rule “a process to conduct risk 

evaluations.” 15 U.S.C. § 2605(b)(4)(B).

TSCA also contains a judicial review provision. See 

15 U.S.C. § 2618. It provides that “not later than 60 days 

after the date on which a rule is promulgated . . . or the date 

on which an order is issued [under TSCA] any person may 

file a petition for judicial review of such rule or order.” 

15 U.S.C. § 2618(a)(1)(A). TSCA specifically authorizes 

judicial review of EPA’s determination that a substance is

low-priority or poses no unreasonable risk. 15 U.S.C. 

§ 2618(a)(1)(A), (a)(1)(C)(i).

C.

In accordance with TSCA, EPA issued rules for 

prioritization and risk evaluation in July 2017. The Risk 
20 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

Evaluation Rule states, generally, that EPA will evaluate 

chemical substances under their conditions of use:

As part of the risk evaluation, EPA will 

determine whether the chemical substance 

presents an unreasonable risk of injury to 

health or the environment under each 

condition of uses [sic] within the scope of the 

risk evaluation, either in a single decision 

document or in multiple decision documents.

40 C.F.R. § 702.47.

The Risk Evaluation Rule similarly explains that “[t]he 

scope of the risk evaluation will include,” among other 

things, “[t]he condition(s) of use, as determined by the 

Administrator, that the EPA plans to consider in the risk 

evaluation.” 40 C.F.R. § 702.41(c). “Conditions of use” is 

defined in the Risk Evaluation Rule as “the circumstances, 

as determined by the Administrator, under which a chemical 

substance is intended, known, or reasonably foreseen to be 

manufactured, processed, distributed in commerce, used, or 

disposed of”—the same definition as in TSCA itself. 

Compare 40 C.F.R. § 702.33, with 15 U.S.C. § 2602(4).

In the preamble to the Risk Evaluation Rule, EPA states 

that three categories of uses and activities are excluded from 

the definition of conditions of use. Procedures for Chemical 

Risk Evaluation Under the Amended Toxic Substances 

Control Act, 82 Fed. Reg. 33,726, 33,729 (July 20, 2017). 

These are: (1) “circumstances associated with activities that 

do not reflect ongoing or prospective manufacturing, 

processing, or distribution,” which the Agency calls “legacy 

uses”; (2) “disposals from such uses,” which the Agency 

calls “associated disposal”; and (3) “disposals that have 

already occurred,” which the Agency calls “legacy 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 21

disposal.” Id. In this litigation, EPA refers to these uses and 

activities collectively as “legacy activities.”

EPA also states, in the preamble to the Risk Evaluation 

Rule, that it “intends to exercise discretion in addressing 

circumstances where [a] chemical substance . . . is 

unintentionally present as an impurity in another chemical 

substance that is not the subject of the pertinent scoping.” 

82 Fed. Reg. at 33,730. In some circumstances, EPA states, 

“it may be most appropriate . . . to evaluate the potential 

risks arising from a chemical impurity within the scope of 

the risk evaluations for the impurity itself,” while in others 

it “may be more appropriate to evaluate such risks within the 

scope of the risk evaluation for the separate chemical 

substances that bear the impurity.” Id. The preamble further 

provides that the Agency “may choose not to include [that] 

impurity within the Scope of any risk evaluation,” where 

“the risk from the presence of the impurity would be ‘de 

minimis’ or otherwise insignificant.” Id. The preamble also 

lists several other uses that commenters had suggested 

should not be considered in risk evaluations, such as misuse 

and illegal use. Id. The preamble ultimately concludes, 

however, that “it would be premature to definitively exclude 

a priori specific conditions of use from risk evaluation.” Id.

D.

Several groups filed petitions for review of the Risk 

Evaluation Rule pursuant to the judicial review provisions of 

TSCA, 15 U.S.C. § 2618, and the Administrative Procedure 

Act, 5 U.S.C. § 706. Those petitions were consolidated.5

 A 

5 Petitioners in this consolidated action are: Safer Chemicals, 

Healthy Families; Alaska Community Action on Toxics; Environmental 

Health Strategy Center; Environmental Working Group; Learning 
22 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

number of industry groups jointly moved to intervene, and a 

motions panel of our court granted the motion.6

Petitioners argue that TSCA requires EPA to evaluate 

risks from uses of a chemical substance collectively, and that 

the Risk Evaluation Rule contradicts this mandate. 

Separately, Petitioners argue that the Risk Evaluation Rule 

expresses an impermissible intent to exclude some 

conditions of use from the scope of a risk evaluation. 

Finally, Petitioners challenge EPA’s exclusion of legacy 

activities from the definition of “conditions of use.”

II.

A.

Petitioners first challenge provisions of the Risk 

Evaluation Rule relating to the process by which EPA will 

conduct risk determinations. Petitioners argue that several 

Disabilities Association of America; Sierra Club; Union of Concerned 

Scientists; United Steel, Paper and Forestry, Rubber, Manufacturing, 

Energy, Allied Industrial and Service Workers International Union, 

AFL-CIO/CLC; WE ACT for Environmental Justice; Asbestos Disease 

Awareness Organization; Vermont Public Interest Research Group; 

Alliance of Nurses for Healthy Environments; Cape Fear River Watch; 

Natural Resources Defense Council; and Environmental Defense Fund.

6 Intervenors are: American Chemistry Council; American Coatings 

Association; American Coke and Coal Chemicals Institute; American 

Forest & Paper Association; American Fuel & Petrochemical 

Manufacturers; American Petroleum Institute; Battery Council 

International; Chamber of Commerce of the United States of America; 

EPS Industry Alliance; IPC International, Inc.; National Association of 

Chemical Distributors; National Mining Association; Polyurethane 

Manufacturers Association; Silver Nanotechnology Working Group; 

Society of Chemical Manufacturers and Affiliates; Styrene Information 

and Research Center, Inc.; and Utility Solid Waste Activities Group.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 23

provisions in the Rule assert that EPA has authority to 

determine whether individual conditions of use, in isolation, 

pose unreasonable risks, rather than to evaluate the risks 

posed by a chemical substance holistically. Specifically, 

Petitioners challenge three provisions of the Rule. First is 

EPA’s statement that it “will determine whether the 

chemical substance presents an unreasonable risk of injury 

to health or the environment under each condition of use[] 

within the scope of the risk evaluation, either in a single 

decision document or in multiple decision documents.” See 

40 C.F.R. § 702.47. Second is the Rule’s statement that:

EPA will complete the risk evaluation of the 

chemical substance addressing all of the 

conditions of use within the scope of the 

evaluation. However, EPA may complete its 

evaluation of the chemical substance under 

specific conditions of use or categories of 

conditions of use at any point following the 

issuance of the final scope document, and 

issue its determination as to whether the 

chemical substance under those conditions of 

use does or does not present an unreasonable 

risk to health or the environment under those 

conditions of use.

40 C.F.R. § 702.41(a)(9).

Finally, Petitioners challenge a provision of the Rule 

entitled “Final determination of no unreasonable risk,” 

which states:

A determination by EPA that the chemical 

substance, under one or more of the 

conditions of use within the scope of the risk 

evaluation, does not present an unreasonable 
24 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

risk of injury to health or the environment 

will be issued by order and considered to be 

a final Agency action.

40 C.F.R. § 702.49(d).

Petitioners interpret these provisions to mean that EPA 

plans to conduct use-by-use risk determinations and to 

declare the safety of individual uses of a chemical standing 

alone, without first considering whether its conditions of use, 

viewed together, pose an unreasonable risk. Petitioners 

argue that this contravenes TSCA’s requirement that EPA 

“conduct risk evaluations . . . to determine whether a 

chemical substance presents an unreasonable risk . . . under 

the conditions of use.” See 15 U.S.C. § 2605(b)(4)(A). 

Petitioners emphasize TSCA’s reference to the risk of “a 

chemical substance,” arguing that this requires the agency to 

conduct a holistic assessment of a chemical under all of its 

conditions of use, rather than to assess risks from individual 

conditions of use.

Petitioners recognize that when EPA decides that a 

particular condition of use does pose an unreasonable risk, 

such a determination on its own complies with TSCA’s 

requirement that EPA conduct an evaluation of whether “the 

substance as a whole poses unreasonable risk.” That is 

because, as Petitioners explain, if any condition of use (or 

any combination of subsets of the conditions of use) 

associated with a chemical poses an unreasonable risk of 

harm, that chemical substance would necessarily pose an 

unreasonable risk under all of its conditions of use 

considered together. As soon as the Agency determines that 

any combination of conditions of use pose such a risk, 

therefore, the Agency may proceed to regulate that chemical 

under 15 U.S.C. § 2605(a). Petitioners contend that the Risk 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 25

Evaluation Rule goes one step further, however, allowing 

EPA to issue a final determination that a chemical substance 

does not pose an unreasonable risk after having looked at 

only one or a few of its conditions of use. Petitioners argue 

that, under TSCA, the Agency may only issue a “no 

unreasonable risk” determination for a chemical substance 

after it has considered the risks associated with all of that 

substance’s conditions of use.7

We hold that this challenge is not justiciable because 

Petitioners’ interpretation of what EPA intends to do and 

Petitioners’ resulting theory of injury are too speculative.

1.

“Article III of the Constitution empowers us to 

adjudicate only ‘live cases or controversies,’ not ‘to issue 

advisory opinions [or] to declare rights in hypothetical 

cases.’” Clark v. City of Seattle, 899 F.3d 802, 808 (9th Cir. 

2018) (quoting Thomas v. Anchorage Equal Rights Comm’n, 

220 F.3d 1134, 1138 (9th Cir. 2000) (en banc)). The 

requirement of Article III standing “aids the federal judiciary 

to avoid intruding impermissibly upon the powers vested in 

the executive and legislative branches, by preventing courts 

from issuing advisory opinions not founded upon the facts 

of a controversy between truly adverse parties.” Scott v. 

Pasadena Unified Sch. Dist., 306 F.3d 646, 654 (9th Cir. 

2002). For purposes of standing, a plaintiff must establish 

he or she has “(1) suffered an injury in fact, (2) that is fairly 

traceable to the challenged conduct of the defendant, and 

7 No party discusses, so we do not reach, whether a broader 

evaluation of risks would be required to comply with 15 U.S.C. 

§ 2605(a) at the regulation stage, if the predicate determination of 

unreasonable risk had been made based on fewer than all of a substance’s 

conditions of use.
26 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

(3) that is likely to be redressed by a favorable judicial 

decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 

(2016).

An “injury in fact” is “an invasion of a legally protected 

interest which is (a) concrete and particularized, and 

(b) actual or imminent, not conjectural or hypothetical.” 

Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992) 

(citations and quotation marks omitted). A “concrete” injury 

is one that “actually exist[s],” meaning that it is “real, and 

not abstract.” Spokeo, 136 S. Ct. at 1548 (quotation marks 

omitted). Both “[i]ntangible harms and a ‘risk of real harm’ 

can be sufficiently concrete” for these purposes. Bassett v. 

ABM Parking Servs., Inc., 883 F.3d 776, 779 (9th Cir. 2018)

(quoting Spokeo, 136 S. Ct. at 1549–50). A “particularized” 

injury is one that “affect[s] the plaintiff in a personal and 

individual way.” Spokeo, 136 S. Ct. at 1548 (quoting Lujan, 

504 U.S. at 560 n.1).

“Ripeness is [another] . . . doctrine[] that we use to 

determine whether a case presents a live case or 

controversy” over which we have jurisdiction under 

Article III. Clark, 899 F.3d at 808. Ripeness doctrine

is designed “to prevent the courts, through 

avoidance of premature adjudication, from 

entangling themselves in abstract 

disagreements over administrative policies, 

and also to protect . . . agencies from judicial 

interference until an administrative decision 

has been formalized and its effects felt in a 

concrete way by the challenging parties.”

Ohio Forestry Ass’n, Inc. v. Sierra Club, 523 U.S. 726, 732–

33 (1998) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 

148–49 (1967), abrogated on other grounds by Califano v. 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 27

Sanders, 430 U.S. 99, 105 (1977)). Because ripeness 

doctrine derived “both from Article III limitations on judicial 

power and from prudential reasons for refusing to exercise 

jurisdiction,” Clark, 899 F.3d at 809 (quoting Thomas, 

220 F.3d at 1138), the “ripeness inquiry” has often involved 

“both ‘a constitutional and a prudential component,’” id.

(quoting Bishop Paiute Tribe v. Inyo County, 863 F.3d 1144, 

1153 (9th Cir. 2017)).

To satisfy the constitutional ripeness requirement, a case 

“must present issues that are definite and concrete, not 

hypothetical or abstract.” Id. (quoting Bishop Paiute Tribe, 

863 F.3d at 1153). “[S]orting out where standing ends and 

ripeness begins is not an easy task,” id. (quoting Thomas, 

220 F.3d at 1138), so “[c]onstitutional ripeness is often 

treated under the rubric of standing because ripeness 

coincides squarely with standing’s injury in fact prong,” id.

(alteration in original) (quoting Bishop Paiute Tribe, 

863 F.3d at 1153).

Where (as here) there is a judicial review provision in a 

statute, any prudential ripeness considerations are satisfied 

for cases brought under that provision.8 See Ohio Forestry

Ass’n, 523 U.S. at 737 (citing TSCA’s judicial review 

provision in 15 U.S.C. § 2618 as an example of a statute in 

which Congress provided for pre-enforcement review, and 

suggesting that such a provision renders a pre-enforcement 

challenge prudentially ripe); see also Shalala v. Ill. Council 

8 We noted in Clark that “[t]he Supreme Court . . . cast doubt on the 

prudential component of ripeness in Susan B. Anthony List v. Driehaus, 

[573 U.S. 149 (2014)].” 899 F.3d at 809 n.4. In Clark, like the Court in 

Susan B. Anthony List, we did not need to “resolve the continuing vitality 

of the prudential ripeness doctrine.” Id. (quoting Susan B. Anthony List, 

573 U.S. at 167). The same is true here because any potential prudential 

ripeness concerns are resolved by TSCA’s judicial review provision.
28 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

on Long Term Care, Inc., 529 U.S. 1, 12–13 (2000) 

(referring to statutorily authorized pre-enforcement review 

as an exception to ripeness and exhaustion requirements, and 

likewise citing § 2618 as an example).

Although a judicial review provision like that in 

15 U.S.C. § 2618 avoids any prudential ripeness concerns 

about claims brought under that provision, such a provision 

does not make a claim constitutionally ripe. The Supreme 

Court emphasized in Spokeo that Congress cannot confer 

Article III jurisdiction when it is otherwise lacking. See 

Spokeo, 136 S. Ct. at 1547–48 (“Injury in fact is a 

constitutional requirement, and ‘[i]t is settled that Congress 

cannot erase Article III’s standing requirements by 

statutorily granting the right to sue to a plaintiff who would 

not otherwise have standing.’” (alteration in original) 

(quoting Raines v. Byrd, 521 U.S. 811, 820 n.3 (1997))). 

And while Spokeo itself addressed Article III standing, the 

same is necessarily true of Article III ripeness, which is also 

a constitutional requirement. See Stolt-Nielsen S.A. v. 

AnimalFeeds Int’l Corp., 559 U.S. 662, 670 n.2 (2010) 

(“Ripeness reflects constitutional considerations that 

implicate ‘Article III limitations on judicial power.’” 

(quoting Reno v. Catholic Soc. Servs., Inc., 509 U.S. 43, 57 

n.18 (1993))); cf. Barenblatt v. United States, 360 U.S. 109, 

112 (1959) (“Congress . . . must exercise its powers subject 

to the limitations placed by the Constitution on 

governmental action.”). Petitioners must therefore establish 

that their case is justiciable under the Article III doctrines of 

standing and ripeness, with respect to each of their claims.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 29

2.

a.

Petitioners argue that they are injured by the use-by-use 

approach of the Risk Evaluation Rule in two ways. First, 

Petitioners contend, the use-by-use approach will lead EPA 

to underestimate risk where exposure results from multiple 

activities involving a chemical, which threatens their 

concrete interests in avoiding harmful exposures to 

chemicals. Second, they argue that the Rule will deprive 

them of information about chemical risks to which they are 

entitled under TSCA and that they need to reduce exposures 

to toxic chemicals.9

 Petitioners maintain that these injuries 

are imminent, noting, for example, that their members are 

currently exposed to a chemical flame retardant that is 

already undergoing risk evaluation. They also argue that 

their claims are ripe, pointing to TSCA’s judicial review 

provision and the harm they argue would be caused by 

9 Petitioners further argue that their members are injured by EPA’s 

failure to follow the correct procedures. But Petitioners have not shown 

that EPA has actually failed to follow any specific procedures—at most, 

Petitioners’ claim is that EPA has indicated, in promulgating the Risk 

Evaluation Rule, that it intends to not follow correct procedures. Even 

if that is so, the Agency has not yet taken a specific action that could 

have violated a procedural or statutory right (e.g., by completing a risk 

evaluation without following procedures required by TSCA), so this case 

differs from ones arising out of alleged procedural injuries. See, e.g., 

Friends of Santa Clara River v. U.S. Army Corps of Eng’rs, 887 F.3d 

906, 910 (9th Cir. 2018) (challenge under National Environmental Policy 

Act (“NEPA”), Endangered Species Act, and Clean Water Act to an 

agency’s process in issuing a permit authorizing discharge of materials 

into a river); Citizens for Better Forestry v. U.S. Dep’t of Agric., 341 F.3d 

961, 970 (9th Cir. 2003) (holding that the plaintiffs “were deprived of 

the opportunity to comment on the [agency’s NEPA documents] at all 

points in the rulemaking process,” and that “[t]his deprivation violated 

their rights under the regulations implementing NEPA”).
30 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

delaying the performance of risk evaluations that comply 

with TSCA.

EPA argues that Petitioners’ claim is nonjusticiable 

because it is based merely on a “hypothes[i]s about how EPA 

may apply [the Rule] in the future,” and therefore Petitioners 

have not alleged “a concrete or particularized injury.” EPA 

maintains that if it ever does take final agency action that 

Petitioners believe fails to comply with TSCA’s 

requirements, then Petitioners could challenge that action. 

Intervenors agree with EPA that this claim is not justiciable, 

because the existence of the Risk Evaluation Rule itself 

could not possibly cause Petitioners any injury.

b.

We conclude that Petitioners’ challenge regarding useby-use risk evaluations is not justiciable because it is not 

clear, due to the ambiguous text of the Risk Evaluation Rule, 

whether the Agency will actually conduct risk evaluations in 

the manner Petitioners fear.

Petitioners rely heavily on the Rule’s reference to 

“whether [a] chemical substance presents an unreasonable 

risk of injury to health or the environment under each 

condition of use[] within the scope of the risk evaluation.” 

40 C.F.R. § 702.47 (emphasis added). One reading of this 

provision (and its use of the term “each”) does suggest that 

EPA will evaluate risks associated with conditions of use 

individually. But it does not necessarily mean that EPA will 

(or even could) make determinations of “no unreasonable 

risk” based only on individual use-by-use evaluations, rather 

than on an evaluation that looks at “each” condition—as in 

“every one of the” conditions—of use together.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 31

The same is true of the statement in 40 C.F.R. 

§ 702.41(a)(9) that Petitioners challenge, which provides 

that “EPA will complete the risk evaluation of the chemical 

substance addressing all of the conditions of use within the 

scope of the evaluation.” This could well mean EPA will do 

exactly what Petitioners argue it must: consider all 

conditions of use before completing a risk determination for 

a chemical. It also states that “EPA may complete its 

evaluation of the chemical substance under specific 

conditions of use or categories of conditions of use at any 

point following the issuance of the final scope document, 

and issue its determination as to whether the chemical 

substance under those conditions of use does or does not 

present an unreasonable risk.” 40 C.F.R. § 702.41(a)(9). 

But again, although this suggests that EPA plans to conduct 

some use-by-use risk determinations, it does not clearly 

mean that EPA will fail to do what Petitioners argue is 

required under TSCA.

The last provision that Petitioners challenge, 40 C.F.R. 

§ 702.49(d), is no different. There, the Rule states merely 

that “[a] determination by EPA that the chemical substance, 

under one or more of the conditions of use within the scope 

of the risk evaluation, does not present an unreasonable risk 

. . . will be issued by order and considered to be a final 

Agency action.” 40 C.F.R. § 702.49(d). We simply do not 

know what this provision means either, or how the Agency 

will apply it in any particular case.

Other provisions in the Rule are similarly ambiguous. 

One states:

In general, EPA intends to determine whether 

a chemical substance does or does not present 

an unreasonable risk under all of the 

conditions of use within the scope of the risk 
32 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

evaluations, and intends to identify the 

individual conditions of use or categories of 

conditions of use that are responsible for such

determinations.

40 C.F.R. § 702.41(a)(8). Again, this might well mean that 

EPA will evaluate whether a substance poses an 

unreasonable risk under each use individually, or it might 

mean that the Agency will consider conditions of use 

collectively, as Petitioners wish. And a provision entitled 

“Final determination of unreasonable risk,” which appears 

immediately before the challenged § 702.49(d), states that 

EPA will regulate a substance if it determines that “under 

one or more of the conditions of use within the scope of the 

risk evaluation [the substance] presents an unreasonable risk 

of injury to health or the environment.” 40 C.F.R.

§ 702.49(c). This might comport with Petitioners’ 

understanding of TSCA’s requirements: that the relevant 

question is whether a chemical substance poses an 

unreasonable risk under any one condition of use, or under 

any combination of uses.

And, in fact, the preamble to the Risk Evaluation Rule 

weighs against Petitioners’ understanding of EPA’s plans, as 

it supports the notion that EPA will evaluate risks 

collectively, just as Petitioners wish: “[T]he Agency is to 

exercise [its] discretion consistent with the objective of 

conducting a technically sound, manageable evaluation to 

determine whether a chemical substance—not just 

individual uses or activities—presents an unreasonable 

risk.” Procedures for Chemical Risk Evaluation Under the 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 33

Amended Toxic Substances Control Act, 82 Fed. Reg. 

33,726, 33,729 (July 20, 2017).10

The lack of clarity in what the regulations promulgated 

by EPA mean creates a justiciability problem with 

Petitioners’ claim. To the extent it is not clear how EPA will 

actually conduct risk evaluations under these rules, there is 

no concrete, imminent harm to Petitioners’ interests that is 

caused by the challenged provisions. On this point we look 

to two analogous contexts: pre-enforcement challenges to 

rules that proscribe certain behavior, and challenges to rules 

that confer benefits on individuals.

In the context of pre-enforcement challenges to agency 

rules governing the behavior of regulated parties, we have 

recognized that “[n]either the ‘mere existence of a 

proscriptive statute’ nor a ‘generalized threat of prosecution’ 

satisfies the ‘case or controversy’ requirement.” Wolfson v. 

Brammer, 616 F.3d 1045, 1058 (9th Cir. 2010) (quoting 

Thomas, 220 F.3d at 1139). Rather, “for a claim to be ripe, 

the plaintiff must be subject to a genuine threat of imminent 

prosecution.” Id. (quotation marks and emphasis omitted). 

In evaluating the existence of any such genuine threat, we 

look at three criteria: “(1) whether the plaintiff has 

articulated a concrete plan to violate the law in question; 

(2) whether the prosecuting authorities have communicated 

a specific warning or threat to initiate proceedings; and 

(3) the history of past prosecution or enforcement under the 

10 By contrast, EPA has asserted in its briefing to our court that it 

has flexibility, under the Risk Evaluation Rule, to conduct use-by-use 

“no unreasonable risk” determinations. Elsewhere in its briefs, however, 

EPA contends that “[u]nder the [Risk Evaluation Rule], EPA will, in 

fact, issue final risk evaluations for entire chemical substances.” These 

contradictory statements add to the ambiguity about how EPA plans to 

conduct risk evaluations.
34 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

challenged statute.” Id.; see also Susan B. Anthony List v. 

Driehaus, 573 U.S. 149, 159 (2014) (“[W]e have held that a 

plaintiff satisfies the injury-in-fact requirement where he 

alleges ‘an intention to engage in a course of conduct 

arguably affected with a constitutional interest, but 

proscribed by a statute, and there exists a credible threat of 

prosecution thereunder.’” (quoting Babbitt v. United Farm 

Workers Nat’l Union, 442 U.S. 289, 298 (1979))).

In the context of “benefit-conferring rule[s],” Mont. 

Envtl. Info. Ctr. v. Stone-Manning, 766 F.3d 1184, 1190 (9th 

Cir. 2014) (quoting Reno, 509 U.S. at 69 (O’Connor, J., 

concurring in the judgment)), we have applied a “firm 

prediction rule” to determine constitutional ripeness, id. 

Under that rule, drawn from Justice O’Connor’s concurring 

opinion in Reno v. Catholic Social Services, Inc. and adopted 

by our court in Freedom to Travel Campaign v. Newcomb, 

82 F.3d 1431 (9th Cir. 1996), we ask whether we “can make 

a firm prediction that the plaintiff will apply for the benefit 

[at issue], and that the agency will deny the application by 

virtue of the [challenged] rule.” Id. at 1436 (quoting Reno, 

509 U.S. at 69 (O’Connor, J., concurring in the judgment)).

While neither of these lines of cases speaks directly to 

the issue that we now face, both clearly aim to deduce, in 

different contexts, the extent to which a claimed injury is 

actually and non-speculatively impending. Applying the 

principles underlying each of these tests, we conclude that 

Petitioners’ challenge regarding use-by-use determinations 

is not justiciable. Because of the ambiguity in the rules, we 

cannot predict whether Petitioners will be harmed in the way 

they claim, or whether the Agency will in fact apply these 

rules as Petitioners wish.

Clark v. City of Seattle is also instructive in this regard. 

In Clark, Seattle’s city council passed an ordinance 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 35

establishing a multistep collective bargaining process 

applicable to ride-hailing services. A group of drivers sued, 

challenging the legality of the ordinance, and we held that 

the challenge was not ripe under Article III. 899 F.3d at 809 

n.4. Among other things, we noted that injury to the drivers 

was not actual or imminent, because it would occur only if a 

contract or agreement was in fact reached—and no such 

contract or agreement was near. Id. at 810–11. The assertion 

of injury was therefore “wholly speculative.” Id. at 811. 

Petitioners’ theory of injury in this case is even more 

speculative. In Clark, it was clear what the procedures 

would be but unclear whether they would actually be 

invoked. Here, it is not even clear what EPA’s procedures 

will be, let alone whether EPA will employ them in a way 

that injures Petitioners.

Because Petitioners’ theory of injury is dependent upon 

harm caused by a failure to assess all conditions of use 

together, and because it is very uncertain whether EPA ever 

plans to do what Petitioners fear, Petitioners’ alleged injury 

is too speculative at this time to establish Article III 

jurisdiction. See Clinton v. City of New York, 524 U.S. 417, 

432 (1998) (emphasizing that plaintiffs must establish a 

“sufficient likelihood of . . . injury to establish standing”). If 

EPA does, in the future, fail to consider all conditions of use 

together in completing a risk evaluation, and if Petitioners 

are harmed by that failure, then Petitioners may, under 

TSCA, seek review of EPA’s “no unreasonable risk” 

determination. See 15 U.S.C. §§ 2618(a)(1)(A),

2605(i)(1).11 Petitioners would at that time have standing to 

11 Likewise, to the extent EPA decides it has discretion under the 

Prioritization and Risk Evaluation Rules to consider risk on a use-by-use 

basis, and not holistically, and to the extent that decision affects the 

Agency’s prioritization decisions, Petitioners may challenge EPA’s 
36 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

sue, and such a claim would be ripe for review. And EPA 

has insisted—both at oral argument and in its briefing here—

that Petitioners would be able to challenge an allegedly 

improper risk determination. See 15 U.S.C. 

§ 2618(a)(1)(A).

B.

Petitioners next argue that the Risk Evaluation Rule 

contravenes TSCA’s requirement that EPA consider all of a 

chemical’s conditions of use when conducting a risk 

evaluation—which Petitioners assert is required whether or 

not Petitioners are correct in their argument, discussed 

above, that the risk analysis should look at uses collectively. 

Petitioners’ challenge relating to the proper scope of a risk 

evaluation comes in two forms: a challenge to preambular 

language, and challenges to provisions of the Risk 

Evaluation Rule (which we will refer to as the “scope 

provisions”).

First, Petitioners identify language in the preamble to the 

Risk Evaluation Rule that they contend reflects EPA’s intent 

not to consider every condition of use. For example, 

Petitioners direct our attention to EPA’s suggestion that it 

may exclude circumstances in which a substance is 

unintentionally present as an impurity in a second chemical 

from the risk evaluation of the substance present as the 

impurity, and may instead evaluate the risks associated with 

the impurity in the context of the second chemical. See 

82 Fed. Reg. at 33,730. Petitioners also point to EPA’s 

suggestion that it may disregard the existence of that 

designation of a particular substance as low-priority. See 15 U.S.C. 

§§ 2618(a)(1)(C)(i), 2605(b)(1)(B)(ii).
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 37

impurity entirely if its associated risk would be de minimis. 

Id.

Second, Petitioners challenge several provisions of the 

Risk Evaluation Rule itself, relying to some extent on the 

preamble to support these claims. Specifically, Petitioners 

challenge the Risk Evaluation Rule’s statement that “[t]he 

scope of the risk evaluation will include . . . [t]he 

condition(s) of use, as determined by the Administrator, that 

the EPA plans to consider in the risk evaluation.” See 

40 C.F.R. § 702.41(c). Petitioners also point to EPA’s 

references in the Risk Evaluation Rule to the conditions of 

use “within the scope of” the evaluation, see 40 C.F.R. 

§§ 702.41(a)(5), (a)(8), (a)(9), (c)(4)(i), (c)(4)(iii), (d)(2); 

702.49(b)–(d), arguing that this wording further shows that 

EPA does not intend to consider all conditions of use. 

Petitioners express similar concern about the provision on 

manufacturer-requested risk evaluations:

EPA will assess whether the circumstances 

identified in the request constitute condition 

[sic] of use under [the Risk Evaluation Rule’s 

definition section], and whether those 

conditions of use warrant inclusion within the 

scope of a risk evaluation for the chemical 

substance. EPA will also assess what, if any, 

additional conditions of use that [sic] warrant 

inclusion within the scope of a risk evaluation 

for the chemical substance.

40 C.F.R. § 702.37(e)(3). Petitioners argue that these 

provisions demonstrate that not all conditions of use will be 

in the scope of a risk evaluation, and that EPA is asserting 

discretion to exclude some conditions of use.
38 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

With respect to the challenged preambular language, we 

hold that it is not final agency action, and thus is not 

reviewable under the Administrative Procedure Act. We are 

left, then, with Petitioners’ challenges to specific provisions 

of the Risk Evaluation Rule. Although we conclude that 

these challenges are justiciable, we hold that they fail on the 

merits because the provisions that Petitioners point to do not, 

as Petitioners contend, in fact assert discretion to exclude 

conditions of use from evaluation.

1.

The Administrative Procedure Act gives courts the 

authority to review final agency action. See 5 U.S.C. § 704; 

see also Nat. Res. Def. Council v. EPA, 643 F.3d 311, 319 

(D.C. Cir. 2011) (referring to finality as a “jurisdictional 

issue[]”). A final agency action is one that “mark[s] the 

consummation of the agency’s decisionmaking process,” 

and one “by which rights or obligations have been 

determined, or from which legal consequences will flow.” 

U.S. Army Corps of Eng’rs v. Hawkes Co., 136 S. Ct. 1807, 

1813 (2016) (quoting Bennett v. Spear, 520 U.S. 154, 177–

78 (1997)). Formally promulgated rules are the bread and 

butter of final agency actions. See Dole v. United 

Steelworkers of Am., 494 U.S. 26, 33 (1990) (“The 

promulgation of a disclosure rule is a final agency action.”); 

Cal. Sea Urchin Comm’n v. Bean, 828 F.3d 1046, 1049 (9th 

Cir. 2016) (“The 1987 Final Rule was clearly a final agency 

action.”). A regulation’s “preamble may under some 

circumstances be reviewable” as final agency action. 

Kennecott Utah Copper Corp. v. U.S. Dep’t of Interior, 

88 F.3d 1191, 1222 (D.C. Cir. 1996); see also Ctr. for 

Biological Diversity v. Nat’l Highway Traffic Safety Admin., 

538 F.3d 1172, 1181 n.1 (9th Cir. 2008) (“We do not address 

this issue since the parties agreed . . . that the preemption 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 39

discussion in the preamble of the Final Rule is not final 

agency action and thus not currently reviewable.”). “The 

question of reviewability hinges upon whether the preamble 

has independent legal effect, which in turn is a function of 

the agency’s intention to bind either itself or regulated 

parties.” Kennecott, 88 F.3d at 1223. Even “[a]bsent an 

express statement [of intent], we may yet infer that the 

agency intended the preamble to be binding if what it 

requires is sufficiently clear.” Id.

In the preamble to the Risk Evaluation Rule, the Agency 

noted that based on its reading of TSCA, it “may, on a caseby-case basis, exclude certain activities that EPA has 

determined to be conditions of use in order to focus its 

analytical efforts on those exposures that are likely to present 

the greatest concern.” 82 Fed. Reg. at 33,729. The Agency 

indicated that it may do so when a risk associated with a use 

would be de minimis, or when another regulatory agency has 

already assessed that use. Id.

In a section of the preamble entitled “Conditions of use 

that may be excluded from the [s]cope of the risk 

evaluation,” id. at 33,730, EPA “elaborate[d] further on 

this,” id. at 33,729. There, EPA explained that it “intends to 

exercise discretion in addressing circumstances where [a] 

chemical substance . . . is unintentionally present as an 

impurity in another chemical substance that is not the subject 

of the pertinent scoping.” Id. at 33,730. In some 

circumstances, EPA stated, “it may be most appropriate . . . 

to evaluate the potential risks arising from a chemical 

impurity within the scope of the risk evaluations for the 

impurity itself,” while in others it “may be more appropriate 

to evaluate such risks within the scope of the risk evaluation 

for the separate chemical substances that bear the impurity.” 

Id. The Agency further provided that it “may choose not to 
40 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

include [that] impurity within the [s]cope of any risk 

evaluation,” where “the risk from the presence of the 

impurity would be ‘de minimis’ or otherwise insignificant.” 

Id. EPA also listed several other uses that commenters had 

suggested should not be considered in risk evaluations, 

including: “[u]ses where other agencies hold jurisdiction, 

misuse, illegal use, speculative future conditions of use, [or] 

uses that are inconsistent with labeling requirements.” Id. 

EPA ultimately concluded, however, that “it would be 

premature to definitively exclude a priori specific conditions 

of use from risk evaluation.” Id.

This is not the sort of language that indicates an agency 

has intended to bind itself—in fact, it appears to be just the 

opposite. The preambular language concerning the scope of 

risk evaluations indicates only that EPA could “exercise 

discretion” about the context in which it could evaluate a 

substance that is present as an impurity, and “may choose not 

to” ever consider the impurity when its risk would be de 

minimis. See id. (emphasis added); see also Nat. Res. Def. 

Council v. EPA, 559 F.3d 561, 565 (D.C. Cir. 2009) 

(emphasizing, in the context of evaluating finality, a 

distinction between “may” and “will”). The Agency 

referenced other uses that commenters had suggested should 

be excluded from the scope of a risk evaluation, but 

explicitly decided not to definitively exclude any “specific 

conditions of use,” explaining that it would make 

“reasonable, technically sound scoping decisions” with 

respect to each individual substance evaluated. 82 Fed. Reg. 

at 33,730. The preamble language does not bind the agency 

to ever exclude any conditions of use from consideration. It 

therefore is not reviewable as final agency action under the 

Administrative Procedure Act.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 41

2.

We turn next to Petitioners’ challenge to the scope 

provisions. These provisions, as part of the Rule itself, 

clearly qualify as final agency action, see Cal. Sea Urchin 

Comm’n, 828 F.3d at 1049, and we conclude that Petitioners’ 

challenge to them is justiciable. Nonetheless, Petitioners’ 

challenge fails on the merits. Even assuming TSCA requires 

EPA to consider all conditions of use within the scope of a 

chemical substance’s risk evaluation, the provisions of the 

Risk Evaluation Rule that Petitioners challenge do not 

evince any contrary intent on the part of EPA.

a.

Looking first at Petitioners’ standing to challenge the 

scope provisions of the Risk Evaluation Rule, Petitioners 

argue that they will imminently be harmed by EPA’s 

exclusion of some conditions of use from consideration, 

because EPA will systematically understate risks associated 

with chemicals that are evaluated. Petitioners also argue that 

because (on their reading) the Risk Evaluation Rule allows 

EPA to avoid evaluating some potential risks associated with 

chemical substances, the Rule excludes necessary 

information from EPA’s publications.12

As an initial matter, the challenged language here is not 

ambiguous, so it is not speculative whether the Rule 

authorizes EPA to do what Petitioners claim. This 

12 Because this challenge is to part of the Rule itself, which, as we 

have explained, undoubtedly constitutes final agency action, we need not 

consider whether the challenged language expresses the Agency’s intent 

to bind itself for purposes of deciding whether we may review it. 

Because that language is in the formally promulgated Rule, rather than a 

preamble discussion, it by definition binds the Agency.
42 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

differentiates it from Petitioners’ challenge to use-by-use 

determinations which, as we explained above, is too 

speculative to evaluate. Moreover, to the extent Petitioners 

are correct both that the Risk Evaluation Rule asserts the 

Agency’s discretion to exclude conditions of use and that 

TSCA forecloses the Agency from asserting such discretion, 

their alleged injuries would be caused by the challenged 

provisions. See Nat. Res. Def. Council v. EPA, 643 F.3d 311, 

319–23 (D.C. Cir. 2011). Although, as we explain, we do 

not agree with Petitioners that the Rule provisions actually 

have the effect that Petitioners claim, this distinction bears 

not on Petitioners’ standing but on the merits of their claim. 

See Kirola v. City and County of San Francisco, 860 F.3d 

1164, 1175 (9th Cir. 2017) (Where a district court held that 

a plaintiff lacked standing because she “had not been 

deprived of meaningful access to a challenged service, 

program, or activity,” which was required to establish the 

claim alleged, the district court had “improperly conflated 

[the plaintiff’s] standing with whether she would prevail on 

the merits.” (quotation marks omitted)); see also Whitmore 

v. Arkansas, 495 U.S. 149, 155 (1990) (“Our threshold 

inquiry into standing ‘in no way depends on the merits of the 

[petitioner’s] contention that particular conduct is illegal.’” 

(alteration in original) (quoting Warth v. Seldin, 422 U.S. 

490, 500 (1975))). Petitioners therefore have standing to 

challenge these provisions, and that challenge is ripe.

b.

Petitioners’ challenge to the Rule’s scope provisions, 

however, fails on the merits. The problem with Petitioners’ 

theory is that the meaning they attribute to these provisions 

is inconsistent with the provisions themselves. The phrase 

“the conditions of use within the scope of” an evaluation 

simply refers to the conditions of use that are applicable to 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 43

any particular substance—and that therefore are included in 

the scope of that substance’s evaluation—without excluding 

any conditions of use in forming that list. Likewise, the 

phrase that refers to the conditions of use “that the EPA plans 

to consider” simply refers to the Agency’s role in 

determining what the conditions of use are for a particular 

substance. Petitioners effectively acknowledge as much in 

arguing that the similar language of TSCA itself referring to 

the conditions of use that the Administrator “expects to 

consider” does not grant EPA discretion to exclude 

conditions of use. See 15 U.S.C. § 2605(b)(4)(D). We see 

no reason why “plans to consider” should be read differently 

than “expects to consider.”

The provision on manufacturer-requested risk 

evaluations may lend some support to Petitioners’ contrary 

reading—at least to the extent it suggests that the question 

whether a circumstance constitutes a condition of use is 

separable from the question whether that condition of use 

“warrant[s] inclusion within” a risk evaluation’s scope. See 

40 C.F.R. § 702.37(e)(3). But a more natural reading is that 

this refers, again, simply to the Agency’s discretion (and 

expertise) in determining what constitutes a condition of use 

for a particular chemical substance. We therefore conclude 

that the challenged provisions unambiguously do not grant 

EPA the discretion Petitioners contend. See Encino 

Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1143 (2018) 

(resolving a question of statutory interpretation based on 

“the best reading of the statute”); Nat’l Cable & Telecomms. 

Ass’n v. Gulf Power Co., 534 U.S. 327, 333 (2002) (“This is 

our own, best reading of the statute, which we find 

unambiguous.”).

We recognize that to the extent a rule is ambiguous, its 

preamble—even if not itself reviewable as final agency 
44 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

action—may help explain the promulgating agency’s intent. 

See City of Las Vegas v. FAA, 570 F.3d 1109, 1117 (9th Cir. 

2009) (“When a regulation is ambiguous, we consult the 

preamble of the final rule as evidence of context or intent of 

the agency promulgating the regulations.”); El Comite Para 

El Bienestar de Earlimart v. Warmerdam, 539 F.3d 1062, 

1070 (9th Cir. 2008) (“[T]he preamble language should not 

be considered unless the regulation itself is ambiguous.”). 

But because the scope provisions are not ambiguous on their 

face, reference to the preamble discussion would be 

improper.

Petitioners also point to the ongoing evaluation of the 

chemical substance 1,4-dioxane, which is a byproduct 

created in manufacturing processes and also appears as a 

contaminant in consumer products. Petitioners contend that 

EPA’s approach to that evaluation is evidence that the Risk 

Evaluation Rule has the effect they fear.13 As Petitioners 

13 EPA made the scope document for 1,4 dioxane publicly available 

online. 1,4-Dioxane Scope Document and Supplemental Files, EPA, 

https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/14

-dioxane-scope-document-and-supplemental-files (last updated June 22, 

2017). We take judicial notice of this document. See Fed. R. Evid. 201; 

Lee v. City of Los Angeles, 250 F.3d 668, 688–89 (9th Cir. 2001) 

(explaining that “a court may take judicial notice of matters of public 

record” under Rule 201 (quotation marks omitted)); see also Sierra Club 

v. EPA, 762 F.3d 971, 975 & n.1 (9th Cir. 2014) (taking judicial notice 

of EPA “public guidance” under Rule 201). We otherwise deny as moot 

Petitioners’ motion to complete the administrative record. See TSG Inc. 

v. EPA, 538 F.3d 264, 272 n.4 (3d Cir. 2008) (denying as moot a motion 

to expand the administrative record because the documents at issue did 

“not alter [the court’s] holding”); Bd. of Regents of Univ. of Wash. v. 

EPA, 86 F.3d 1214, 1222 (D.C. Cir. 1996) (dismissing as moot a 

“Motion to Enlarge the Administrative Record on Review” because it 

“could have no effect on the outcome” of the case).
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 45

emphasize, EPA issued a scope document for 1,4-dioxane 

indicating that the Agency intends to exclude the production 

of 1,4-dioxane in a byproduct form from the scope of the risk 

evaluation for 1,4-dioxane, and intends instead to consider 

those activities in the scope of risk evaluations for other 

chemicals. But Petitioners’ challenge in this action is to the 

Rule itself—not to EPA’s 1,4-dioxane evaluation—and we 

do not interpret the language in the Rule to say anything 

about exclusion of conditions of use.14 Thus, even assuming 

the 1,4-dioxane scope document has the flaws Petitioners 

claim, those flaws would not result from the provisions of 

the Rule Petitioners challenge here.

We therefore conclude that Petitioners’ challenge 

relating to excluding conditions of use from the scope of risk 

evaluations fails.

C.

Finally, we turn to Petitioners’ challenge to EPA’s 

categorical exclusion of legacy activities from the definition 

of “conditions of use.”

TSCA defines the term “conditions of use” to mean: “the 

circumstances, as determined by the Administrator, under 

which a chemical substance is intended, known, or 

reasonably foreseen to be manufactured, processed, 

distributed in commerce, used, or disposed of.” 15 U.S.C. 

§ 2602(4). The definition in the Risk Evaluation Rule 

parrots the statute. See 40 C.F.R. § 702.33. In the preamble 

to the Risk Evaluation Rule, EPA elaborated on this 

14 As EPA emphasizes, Petitioners could challenge the exclusion of 

certain forms or uses of 1,4-dioxane in the context of that chemical 

substance’s final risk determination.
46 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

definition, however, and stated that it does not consider what 

it now calls “legacy activities”—consisting of “legacy uses,” 

“associated disposals,” and “legacy disposals”—to be 

conditions of use. See 82 Fed. Reg. at 33,729–30.

EPA defines the term “legacy uses” in the preamble as 

“the circumstances associated with activities that do not 

reflect ongoing or prospective manufacturing, processing, or 

distribution.” Id. at 33,729. For example, although asbestos 

is now infrequently used in making new insulation, it 

remains in place in previously installed insulation. 

According to EPA’s interpretation, the use of asbestos in 

insulation is a “legacy use” of that chemical. “Associated 

disposal[s]” refers to future disposals from legacy uses, id., 

such as the removal of asbestos-containing insulation to a 

landfill during a building’s renovation. Finally, “legacy 

disposal[s]” are defined as “disposals that have already 

occurred,” regardless of whether the substance disposed of 

is still manufactured for its pre-disposal use. Id. For 

example, this could refer to the previous placement of 

asbestos insulation into a landfill or the previous disposal of 

a chemical substance in a flame retardant that is still used for 

that purpose. Petitioners argue that EPA’s exclusion of these 

legacy activities from the definition of “conditions of use” 

contradicts TSCA’s clear statutory definition of the term.

Again addressing jurisdiction first, we agree with both 

Petitioners and EPA that this claim is justiciable. Proceeding 

to the merits, we hold that EPA’s exclusion of legacy uses 

and associated disposals contradicts TSCA’s plain language, 

but that EPA’s exclusion of legacy disposals does not.

1.

Petitioners argue that their challenge to EPA’s exclusion 

of each of the three types of legacy activities is justiciable. 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 47

They contend that it is sufficiently clear that EPA has 

categorically excluded legacy activities from consideration 

as conditions of use, and that they will be harmed by these 

exclusions. As to this claim, EPA agrees with Petitioners 

that we have jurisdiction—conceding that Petitioners’ 

allegation that they will be harmed by risk determinations 

that do not include legacy activities “is a sufficient allegation 

for standing purposes,” and that the challenge is ripe because 

“EPA created a general presumption that it will not prioritize 

and evaluate existing chemicals under their legacy uses and 

disposals.” We agree.

Petitioners argue that their members are exposed to—

and injured by—the use of chemical substances through 

legacy activities. For example, Petitioner United Steel, 

Paper and Forestry, Rubber, Manufacturing, Energy, Allied 

Industrial and Service Workers International Union has 

members who, through their work, are exposed to the known 

carcinogen asbestos in the form of legacy uses when 

“equipment or structures are demolished, repaired[,] or 

refurbished.” Petitioners also argue that their members are 

at risk of exposure to asbestos through its associated 

disposal. Petitioners similarly claim that their members 

suffer harmful lead exposures resulting from the “legacy 

use” of lead paint and water pipes.

Petitioners have standing to challenge this exclusion, and 

their challenge is ripe. As Petitioners point out, EPA’s 

interpretation here is “definitional,” and generally 

“requir[es] EPA to ignore ongoing exposures from ‘legacy 

activities’ in every risk evaluation.” Petitioners claim that 

excluding these ongoing exposures from consideration will 

understate a chemical’s health risks, violating Petitioners’ 
48 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

right to risk evaluations that comply with TSCA.15 They 

argue that this threatens their concrete interest in the health 

protections provided by TSCA. EPA’s exclusion of legacy 

activities from the definition of “conditions of use” has the 

clear, immediate effect of excluding broad categories of 

activities from EPA’s consideration in chemical risk 

evaluations, and Petitioners’ alleged resulting injury is 

sufficiently clear and concretely tied to the challenged 

preamble to satisfy the requirements of both standing and 

ripeness.16

2.

In reviewing an agency’s interpretation of a statute, we 

apply the standard articulated by the Supreme Court in 

Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 

Inc., 467 U.S. 837 (1984).17 See Akhtar v. Burzynski, 

384 F.3d 1193, 1198 (9th Cir. 2004). Under Chevron step 

one, we ask “whether Congress has directly spoken to the 

precise question at issue.” Id. At that point, “[i]f the intent 

of Congress is clear, that is the end of the matter; . . . [we] 

15 Petitioners also argue that these exclusions will infect EPA’s 

prioritization decisions.

16 Because this alleged injury alone is enough to support standing, 

we need not decide whether Petitioners could also assert an 

informational injury.

17 Because Congress delegated to EPA the authority to promulgate 

rules establishing a risk evaluation process, and because we conclude 

that the preamble language at issue here constitutes final agency action, 

it is evaluated under Chevron because “it appears that Congress 

delegated authority to the agency generally to make rules carrying the 

force of law, and that the agency interpretation claiming deference was 

promulgated in the exercise of that authority.” United States v. Mead 

Corp., 533 U.S. 218, 226–27 (2001).
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 49

must give effect to the unambiguously expressed intent of 

Congress.” Id. (quoting Chevron, 467 U.S. at 842–43). But 

if “the statute is silent or ambiguous with respect to the 

specific issue, we must ask” at Chevron step two “whether 

the regulations promulgated by the agency are based on a 

permissible construction of the statute.” Id. If they are, we 

“must defer to the agency.” Id. We need not defer to agency 

regulations, however, “if they construe a statute in a way that 

is contrary to congressional intent or that frustrates 

congressional policy.” Id.

a.

As an initial matter, we note that although EPA’s 

exclusion of legacy activities appears in the preamble to the 

Risk Evaluation Rule rather than in the text of the rule itself, 

EPA concedes that its “preamble interpretation regarding 

legacy activities is reviewable because it is a binding 

statutory interpretation that EPA stated it intends to apply 

going forward.” We agree. EPA definitively “resolve[d] the 

[asserted] statutory ambiguity” in the definition of 

“conditions of use” when it announced in the preamble that 

it would exclude legacy activities. 82 Fed. Reg. at 33,730. 

EPA specifically stated that it “interpret[ed] [TSCA’s] 

mandates” to be inapplicable to legacy activities, and 

accordingly “interpret[ed] the definition” of “conditions of 

use.” Id. This interpretation was EPA’s final, unequivocal 

interpretation—there is every reason to believe that the 

Agency intended to bind itself, and what is required by this 

interpretation is, as EPA concedes, sufficiently clear to be 
50 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

reviewable.18 We therefore may evaluate the preamble’s 

exclusion of legacy activities as final agency action.

b.

TSCA defines “conditions of use” as “the circumstances, 

as determined by the Administrator, under which a chemical 

substance is intended, known, or reasonably foreseen to be 

manufactured, processed, distributed in commerce, used, or 

disposed of.” 15 U.S.C. § 2602(4). Interpreting this 

statutory text in the preamble to the Rule, EPA relied on 

what it understood to be TSCA’s “focus on uses for which 

manufacturing, processing, or distribution in commerce is 

intended, known to be occurring, or reasonably foreseen to 

occur (i.e., is prospective or on-going), rather than reaching 

back to evaluate the risks associated with legacy uses, 

associated disposal, and legacy disposal.” 82 Fed. Reg. at 

33,730. As evidence, EPA pointed to the “to be” phrasing 

in TSCA’s definition of “conditions of use.” Id. EPA also 

noted that TSCA’s legislative history focuses on the 

regulation of chemicals “in commerce.” Id. Finally, the 

Agency stated that TSCA does not authorize it to regulate 

uses of chemicals except by regulating chemicals’ 

manufacture, processing, or distribution. For example, 

although EPA could regulate the production of a flame 

retardant for use in home furniture, the Agency contends in 

its briefing here that it could not prevent individuals who 

already own furniture treated with that flame retardant from 

18 The preamble to the Prioritization Rule similarly stated, in 

definitive terms: “EPA has determined that certain activities generally 

should not be considered to be ‘conditions of use.’” Procedures for 

Prioritization of Chemicals for Risk Evaluation Under the Toxic 

Substances Control Act, 82 Fed. Reg. 33,753, 33,755 (July 20, 2017).
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 51

continuing to use that furniture. Together, such 

considerations led EPA to give TSCA a “prospective 

interpretation” that excludes legacy activities. Id.19

In defending its interpretation here, EPA draws on these 

explanations given in the preamble. EPA further argues that 

the terms “intended” and “reasonably foreseen” as used in 

TSCA’s definition of “conditions of use” “are plainly 

forward looking”; that “known,” when combined with “to 

be,” is a “present tense verb”; and that “intended,” “known,” 

and “reasonably foreseen” are all “broad, general terms that 

plainly require EPA to exercise its judgment.” This 

language, EPA contends, demonstrates that Congress 

intended EPA to focus on activities for which the 

manufacturing, processing, or distribution in commerce of a 

chemical is intended, known, or reasonably foreseen. EPA 

also argues that it would make little sense to interpret 

conditions of use to include activities that EPA has little time 

to evaluate or ability to regulate, and that TSCA should be 

interpreted to allow the Agency to focus on quickly 

regulating the worst risks, which it contends do not arise 

from legacy activities.

Petitioners argue that EPA’s interpretation is 

contradicted by the plain text of TSCA’s statutory definition 

of “conditions of use,” and is not saved by any grant of 

unfettered discretion to the Agency. Petitioners argue that 

19 In the preamble, EPA also concluded that its interpretation finds 

“support in the general presumption against construing a statute (or 

implementing regulation) to be retroactive or have retrospective effect.” 

82 Fed. Reg. at 33,730. It noted that “[w]hile Congress can make a law 

retroactive, absent clear intent from Congress, courts will not hold a 

statute to be retroactive, or uphold an agency regulation that seeks to 

have such an effect.” Id. EPA does not rely on this argument in 

responding to this Petition for Review.
52 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

EPA’s interpretation, which only includes the use and 

subsequent disposal of chemicals that also continue to be 

manufactured, processed, or distributed in commerce for that 

same use, fails to give independent meaning to “use” and 

“disposal” in the statutory definition’s disjunctive list 

(“manufactured, processed, distributed in commerce, used, 

or disposed of”). For instance, Petitioners note, “lead pipes 

are ‘known to be used’ in water distribution systems,” and 

“[t]his is true regardless of whether lead pipes continue to be 

manufactured or distributed.” Petitioners also argue that an 

interpretation that “would result in inconsistent treatment of 

identical activities based solely on whether manufacture or 

distribution is ongoing,” as EPA’s would, does not square 

with TSCA itself.20 Petitioners dispute EPA’s claim that, 

when a substance is no longer manufactured or distributed 

for a particular use, it is unable to evaluate or regulate that 

use and associated disposal, and argue that even if EPA’s 

assertions to that effect were correct, that would not 

necessitate a finding that EPA could therefore exclude 

consideration of such use and disposal from risk evaluations. 

They further argue that because previously disposed 

substances continue to be present at disposal sites, their 

disposal is ongoing, and captured by TSCA’s definition. 

Finally, Petitioners generally contend that EPA’s exclusion 

of legacy activities “undermine[s] TSCA’s core aim to 

prevent unreasonable risks to health and the environment 

from toxic chemicals.”

20 Petitioners point out that EPA has previously promulgated 

regulations under TSCA to protect against exposure to legacy uses of 

asbestos. See 40 C.F.R. § 763.120–.123.
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 53

c.

EPA’s contention that TSCA can reasonably be read to 

refer to the future use of a product, and disposals associated 

with such use, only when the product will also be 

manufactured in the future for that use—and not when the 

product is no longer manufactured for the relevant use—is 

without merit. TSCA’s “conditions of use” definition 

plainly addresses conditions of use of chemical substances 

that will be used or disposed of in the future, regardless of 

whether the substances are still manufactured for the 

particular use.

Although we agree with EPA that the phrase “to be” in 

the statutory definition denotes the present or future tense, 

when “to be” is combined with “used” and “disposed of,” 

two plain meanings result: future uses, and future disposals. 

And these are precisely the things that EPA has purported to 

exclude by defining conditions of use to exclude legacy uses 

and associated disposals: activities (i.e., uses), “that do not 

reflect ongoing or prospective manufacturing, processing, or 

distribution,”21 and “disposals from such uses,” such as “the 

future disposal of insulation that contains a chemical 

substance that is no longer manufactured, processed, or 

distributed for use in insulation.” See 82 Fed. Reg. at 33,729.

21 Petitioners argue that EPA’s own prior definitions of “use” in the 

context of chemical substances support this understanding, and argue 

that EPA’s exclusion of “legacy use” from conditions of use represents 

an unexplained departure from these prior interpretations. We need not 

decide whether EPA’s prior definitions of “use” in its regulations are in 

any way binding on the Agency here, because “use” has a plain meaning 

within TSCA that, as we explain, clearly encompasses the sorts of things

that EPA categorizes as “legacy uses.”
54 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

The example used by EPA in the Risk Evaluation Rule’s 

preamble—the disposal of insulation previously installed in 

a building—in fact serves as a useful example for why the 

Agency’s interpretation cannot be upheld: The future 

disposal of asbestos insulation is clearly an example of a 

chemical substance being “disposed of.” To the extent it is 

“intended” that such a substance be disposed of, or “known” 

that it will be, or if such disposal is “reasonably foreseen,” 

that circumstance unambiguously falls within TSCA’s 

definition of “conditions of use.” Similarly, as Petitioners 

point out, if lead pipes exist in water distribution systems, 

they are “known to be used” in those systems. This is so 

without any regard to whether these substances are also

intended, known, or reasonably foreseen to be prospectively 

manufactured (or processed, or distributed in commerce) for 

those uses. See 15 U.S.C. § 2602(4) (referring to substances 

that will be “manufactured, processed, distributed in 

commerce, used, or disposed of” (emphasis added)); see also 

Loughrin v. United States, 573 U.S. 351, 357 (2014) (noting 

that the use of the term “or” “is almost always disjunctive, 

that is, the words it connects are to be given separate 

meanings” (quoting United States v. Woods, 571 U.S. 31, 45 

(2013))).

EPA resists this conclusion, arguing that the Agency has 

broad discretion, granted to it by TSCA, to determine what 

constitutes a condition of use.22 We agree that the statute 

22 EPA adds that although it has determined it is not required to 

consider legacy activities in evaluating chemical substances, it may do 

so where appropriate. As Petitioners point out, however, this does not 

save the legacy exclusion if legacy activities are conditions of use that 

EPA is required—rather than just permitted—to consider in risk 

evaluations. Regardless, a plaintiff’s challenge to an agency’s 

unambiguous assertion, in the context of a final agency action, of 

discretion to choose between two alternatives, when one is clearly 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 55

grants EPA discretion to determine the conditions of use for 

each chemical substance, but that discretion may only be 

exercised within the bounds of the statutory definition itself. 

See Massachusetts v. EPA, 549 U.S. 497, 533 (2007) 

(explaining that a statute directing an agency to use its 

“judgment” did not grant the agency “a roving license to 

ignore the statutory text,” but rather directed the agency to 

“exercise discretion within defined statutory limits”). Where 

Congress has explicitly provided a definition for a term, and 

that definition is clear, an agency must follow it. And here, 

as we have explained, TSCA’s definition of “conditions of 

use” clearly includes uses and future disposals of chemicals 

even if those chemicals were only historically manufactured 

for those uses.23 EPA’s exclusion of legacy uses and 

associated disposals from the definition of “conditions of 

use” is therefore unlawful.24

disallowed by statute and, if chosen, would injure the plaintiff, is 

justiciable. See Nat. Res. Def. Council v. EPA, 643 F.3d 311, 319–22 

(D.C. Cir. 2011). The agency’s assertion of discretion would, under 

those circumstances, be impermissible. Id. at 322.

23 This conclusion is bolstered by the fact that TSCA elsewhere 

distinguishes between “active” substances—meaning those that have 

been manufactured or processed since 2006—and “inactive” 

substances—those that have not. TSCA did not, in calling for chemical 

risk evaluations, similarly distinguish between active and inactive 

chemical substances. Compare 15 U.S.C. § 2607(b)(4)(A)(ii)–(iii), with 

15 U.S.C. § 2605. This suggests that Congress intended to make even 

inactive substances subject to prioritization and risk evaluation.

24 To the extent the exclusion is incorporated into EPA’s 

Prioritization Rule, it is also unlawful.
56 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

d.

We draw a distinction, however, between “legacy uses” 

and “associated disposals,” on the one hand, and “legacy 

disposals,” on the other. EPA uses the term “legacy 

disposals” to refer to “disposals that have already occurred 

(e.g., a chemical substance currently in a landfill or in 

groundwater).” 82 Fed. Reg. at 33,729. As to this issue, 

EPA’s present tense argument has more force, and we hold 

that its interpretation is permissible under TSCA.

In our view, TSCA unambiguously does not require past 

disposals to be considered conditions of use. The statutory 

definition, once again, covers the circumstances “under 

which a chemical substance is intended, known, or 

reasonably foreseen to be manufactured, processed, 

distributed in commerce, used, or disposed of.” 15 U.S.C. 

§ 2602(4). A substance that has already been disposed of 

will not ordinarily be intended, known, or reasonably 

foreseen to be prospectively manufactured, processed, 

distributed in commerce, used, or (again) disposed of. Of 

course, there may be some substances that already have been 

disposed of yet are also “known . . . to be . . . distributed in 

commerce” or used. 15 U.S.C. § 2602(4). And TSCA’s 

definition does, as discussed above, clearly cover those 

substances and those prospective uses. But TSCA does not 

address a substance that has already been disposed of and 

remains so.

Petitioners argue that “disposal” in this context “is not a 

one-time occurrence when the substance . . . is buried or 

placed in a landfill or other waste facility,” but rather that 

disposal “remains ongoing after the initial act of discard.” 

By way of example, Petitioners note that although TSCA 

itself does not define the term “disposal,” EPA has 

previously defined the term in the context of regulating 
SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA 57

chemicals known as PCBs, under the pre-2016 TSCA. In 

that context, EPA defines “disposal” to mean “intentionally 

or accidentally to discard, throw away, or otherwise 

complete or terminate the useful life of PCBs and PCB 

Items,” and specifically notes that “[d]isposal includes spills, 

leaks, and other uncontrolled discharges of PCBs as well as 

actions related to containing, transporting, destroying, 

degrading, decontaminating, or confining PCBs and PCB 

Items.” 40 C.F.R. § 761.3. EPA takes issue with 

Petitioners’ reliance on this definition, but acknowledges in 

its briefing here that the term “disposed of” could refer to 

“the act of putting something in a landfill or other resting 

place, or it could conceivably refer to the movement of 

chemicals by natural forces after the initial act of disposal.”

We need not wade into any debate over the precise 

meaning of “disposal.” Even accepting Petitioners’ asserted 

definition, we see no reason why “spills, leaks, and other 

uncontrolled discharges”—or even “actions related to 

containing . . . or confining” substances as also referenced in 

40 C.F.R. § 761.3—would not be considered independent 

disposals. They would thus qualify as “disposals” (and 

therefore conditions of use) for substances that are currently 

manufactured for their pre-disposal use, or “associated 

disposals” for substances that are no longer manufactured for 

their pre-disposal use. If, under the applicable definition of 

“disposal,” something is in fact again disposed of—even if 

it was disposed of previously—or when a disposal is in fact 

ongoing, we see no reason why that use is not captured as a 

prospective disposal. But that does not mean that legacy 

disposals—as used to refer simply to “disposals that have 

already occurred”—should fall under the statutory definition 

of “conditions of use.”
58 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA

Because TSCA’s statutory definition of “conditions of 

use” unambiguously does not reach legacy disposals, we 

hold that the Agency did not err in excluding such disposals 

from consideration as “conditions of use.” See Chevron, 

467 U.S. at 842–43 (“If the intent of Congress is clear, that 

is the end of the matter; for the court, as well as the agency, 

must give effect to the unambiguously expressed intent of 

Congress.”).

III.

For the reasons discussed, the Petition for Review is 

DISMISSED in part, GRANTED in part, and DENIED in 

part.25 The Petition is dismissed with respect to Petitioners’ 

challenge regarding use-by-use determinations. The Petition 

is granted with respect to Petitioners’ challenge to EPA’s 

exclusion of “legacy uses” and “associated disposals” from 

the definition of “conditions of use,” and those portions of 

the Risk Evaluation Rule’s preamble are vacated. The 

Petition is denied with respect to the alleged exclusion of 

conditions of use from the scope of risk evaluation and with 

respect to EPA’s exclusion of “legacy disposals” from 

“conditions of use.” The parties shall bear their own costs 

on appeal.

25 In the concurrently filed memorandum disposition addressing 

Petitioners’ challenge to information-gathering provisions of the 

Prioritization and Risk Evaluation Rules, we further deny the Petition in 

part and remand in part.