Safer Chem Healthy Families v. Usepa

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
SAFER CHEMICALS, HEALTHY No. 17-72260
FAMILIES; ALASKA COMMUNITY
ACTION ON TOXICS;
ENVIRONMENTAL HEALTH STRATEGY
CENTER; ENVIRONMENTAL WORKING
GROUP; LEARNING DISABILITIES
ASSOCIATION OF AMERICA; SIERRA
CLUB; UNION OF CONCERNED
SCIENTISTS; UNITED STEEL, PAPER
AND FORESTRY, RUBBER,
MANUFACTURING, ENERGY, ALLIED
INDUSTRIAL AND SERVICE WORKERS
INTERNATIONAL UNION, AFL-
CIO/CLC; WE ACT FOR
ENVIRONMENTAL JUSTICE; ASBESTOS
DISEASE AWARENESS
ORGANIZATION; VERMONT PUBLIC
INTEREST RESEARCH GROUP,
Petitioners,
v.
U.S. ENVIRONMENTAL PROTECTION
AGENCY; ANDREW WHEELER, *
*
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, No. 17-72501
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
4 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA
RESEARCH CENTER; UTILITY SOLID
WASTE ACTIVITIES GROUP,
Respondents-Intervenors.
ALLIANCE OF NURSES FOR HEALTHY No. 17-72968
ENVIRONMENTS; CAPE FEAR RIVER
WATCH; NATURAL RESOURCES EPA No.
DEFENSE COUNCIL, EPA-HQ-OPPT-
Petitioners, 2016-0636
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;
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 No. 17-73290
ENVIRONMENTS; CAPE FEAR RIVER
WATCH; NATURAL RESOURCES EPA No.
DEFENSE COUNCIL, EPA-HQ-OPPT-
Petitioners, 2016-0654
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
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, No. 17-73383
Petitioner,
EPA No.
v. EPA-HQ-OPPT-
2016-0654
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
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 No. 17-73390
FAMILIES; ALASKA COMMUNITY
ACTION ON TOXICS; EPA No.
ENVIRONMENTAL HEALTH STRATEGY EPA-HQ-OPPT-
CENTER; ENVIRONMENTAL WORKING 2016-0654
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
8 SAFER CHEMICALS, HEALTHY FAMILIES V. USEPA
INTERNATIONAL UNION, AFL-
CIO/CLC; WE ACT FOR
ENVIRONMENTAL JUSTICE; ASBESTOS
DISEASE AWARENESS
ORGANIZATION; VERMONT PUBLIC
INTEREST RESEARCH GROUP,
Petitioners,
v.
U.S. ENVIRONMENTAL PROTECTION
AGENCY; ANDREW WHEELER,
Administrator, United States
Environmental Protection Agency,
Respondents,
AMERICAN CHEMISTRY COUNCIL;
AMERICAN COATINGS ASSOCIATION;
AMERICAN COKE AND COAL
CHEMICALS INSTITUTE; AMERICAN
FOREST & PAPER ASSOCIATION;
AMERICAN FUEL & PETROCHEMICAL
MANUFACTURERS; AMERICAN
PETROLEUM INSTITUTE; BATTERY
COUNCIL INTERNATIONAL; CHAMBER
OF COMMERCE OF THE UNITED
STATES OF AMERICA; EPS INDUSTRY
ALLIANCE; IPC INTERNATIONAL,
INC., doing business as IPC
Association Connecting Electronics
Industries; NATIONAL ASSOCIATION
OF CHEMICAL DISTRIBUTORS;
NATIONAL MINING ASSOCIATION;
POLYURETHANE MANUFACTURERS
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 Respondent-
Intervenor Chamber of Commerce of the United States of
America.
David S. Muraskin and Leah M. Nicholls, Public Justice
P.C., Washington, D.C.; for Amici Curiae American
Academy of Pediatrics, the American College of
Obstetricians and Gynecologists, and the American Public
Health Association.
Paul Olszowka, Barnes & Thornburg LLP, Chicago, Illinois;
for Amicus Curiae People for the Ethical Treatment of
Animals.
OPINION
FRIEDLAND, Circuit Judge:
Petitioners, a variety of environmental groups and other
organizations, seek review of a rule promulgated by the
United States Environmental Protection Agency (“EPA” or
“the Agency”) establishing a process to evaluate the health
and environmental risks of chemical substances. EPA
promulgated the “Risk Evaluation Rule” under its authority
granted by 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 high-
priority, 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 use-
by-use risk evaluations is not justiciable because it is not
clear, due to the ambiguous text of the Risk Evaluation Rule,
whether the Agency will actually conduct risk evaluations in
the manner Petitioners fear.
Petitioners rely heavily on the Rule’s reference to
“whether [a] chemical substance presents an unreasonable
risk of injury to health or the environment under each
condition of use[] within the scope of the risk evaluation.”
40 C.F.R. § 702.47 (emphasis added). One reading of this
provision (and its use of the term “each”) does suggest that
EPA will evaluate risks associated with conditions of use
individually. But it does not necessarily mean that EPA will
(or even could) make determinations of “no unreasonable
risk” based only on individual use-by-use evaluations, rather
than on an evaluation that looks at “each” condition—as in
“every one of the” conditions—of use together.
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 case-
by-case basis, exclude certain activities that EPA has
determined to be conditions of use in order to focus its
analytical efforts on those exposures that are likely to present
the greatest concern.” 82 Fed. Reg. at 33,729. The Agency
indicated that it may do so when a risk associated with a use
would be de minimis, or when another regulatory agency has
already assessed that use. Id.
In a section of the preamble entitled “Conditions of use
that may be excluded from the [s]cope of the risk
evaluation,” id. at 33,730, EPA “elaborate[d] further on
this,” id. at 33,729. There, EPA explained that it “intends to
exercise discretion in addressing circumstances where [a]
chemical substance . . . is unintentionally present as an
impurity in another chemical substance that is not the subject
of the pertinent scoping.” Id. at 33,730. In some
circumstances, EPA stated, “it may be most appropriate . . .
to evaluate the potential risks arising from a chemical
impurity within the scope of the risk evaluations for the
impurity itself,” while in others it “may be more appropriate
to evaluate such risks within the scope of the risk evaluation
for the separate chemical substances that bear the impurity.”
Id. The Agency further provided that it “may choose not to
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.