Chamber of Commerce of the United States of America v. EPA
CourtCourt of Appeals for the D.C. Circuit
Date FiledAugust 18, 2026
Docket24-1193
StatusPublished
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Full Opinion
United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued January 20, 2026 Decided August 18, 2026
No. 24-1193
CHAMBER OF COMMERCE OF THE UNITED STATES OF
AMERICA, ET AL.,
PETITIONERS
v.
ENVIRONMENTAL PROTECTION AGENCY AND LEE M. ZELDIN,
IN HIS OFFICIAL CAPACITY AS ADMINISTRATOR, UNITED
STATES ENVIRONMENTAL PROTECTION AGENCY,
RESPONDENTS
CLEAN CAPE FEAR, ET AL.,
INTERVENORS
Consolidated with Nos. 24-1261, 24-1266, 24-1271, 24-1272
On Petitions for Review of a Final Rule
of the Environmental Protection Agency
Elbert Lin argued the cause for petitioners. With him on
the briefs were Andrew R. Varcoe, Stephanie A. Maloney, Paul
T. Nyffeler, David M. Parker, Matthew Z. Leopold, Christopher
2
L. Bell, Susan Parker Bodine, Richard S. Moskowitz, and Tyler
Kubik. Brittany M. Pemberton entered an appearance.
Michael B. Kimberly and Michael A. Tilghman II were on
the brief for amici curiae National Association of
Manufacturers and Printing United Alliance in support of
petitioners. Nicole E. Wittstein entered an appearance.
Douglas A. Hastings and Mark Donatiello were on the
brief for amicus curiae Superfund Settlements Project in
support of petitioners.
Erica Spitzig, Aaron M. Herzig, Anne M. McClellan, and
David C. Roper were on the brief for amicus curiae Passive
Receivers in support of remand.
Riley W. Walters, Counsel to the Assistant Attorney
General, U.S. Department of Justice, argued the cause for
respondents. On the brief were Adam R.F. Gustafson, Principal
Deputy Assistant Attorney General, and Jin Hyung Lee,
Attorney, and Elizabeth G. Berg and Noel M. Johnson,
Attorneys, U.S. Environmental Protection Agency.
Jonathan Kalmuss-Katz argued the cause for intervenors
Clean Cape Fear, et al. in support of respondents. With him on
the brief were Lillian Zhou and Alana R. Reynolds.
Letitia James, Attorney General for the State of New York,
Barbara D. Underwood, Solicitor General, Judith Vale,
Deputy Solicitor General, Joshua N. Cohen, Assistant Solicitor
General, Philip M. Bein, Senior Counsel, Kyle Burns, Assistant
Attorney General, Mihir Desai, Assistant Attorney General,
Kristin K. Mayes, Attorney General for the State of Arizona,
Philip J. Weiser, Attorney General for the State of Colorado,
William Tong, Attorney General for the State of Connecticut,
3
Brian L. Schwalb, Attorney General for the District of
Columbia, Kwame Raoul, Attorney General for the State of
Illinois, Anthony G. Brown, Attorney General for the State of
Maryland, Andrea J. Campbell, Attorney General for the
Commonwealth of Massachusetts, Dana Nessel, Attorney
General for the State of Michigan, Keith Ellison, Attorney
General for the State of Minnesota, Matthew J. Platkin,
Attorney General for the State of New Jersey, Raúl Torrez,
Attorney General for the State of New Mexico, Dan Rayfield,
Attorney General for the State of Oregon, Nicholas W. Brown,
Attorney General for the State of Washington, and Josh Kaul,
Attorney General for the State of Wisconsin, were on the brief
for amici curiae States of New York, et al. in support of
respondents.
Before: MILLETT, KATSAS, and RAO, Circuit Judges.
Opinion for the Court filed by Circuit Judge MILLETT.
MILLETT, Circuit Judge: Perfluorooctanoic Acid
(“PFOA”) and Perfluorooctanesulfonic Acid (“PFOS”) are two
compounds in a large group of human-made substances
commonly referred to as “forever chemicals.” In 2024, the
Environmental Protection Agency designated PFOA and PFOS
as “hazardous substances” under the Comprehensive
Environmental Response, Compensation, and Liability Act of
1980. EPA based its determination on extensive studies that
link PFOA and PFOS exposure to serious health conditions in
humans, including cancer and developmental delays.
Seven interest groups representing industries that use,
transport, or discharge PFOA and PFOS petitioned this court
to overturn EPA’s decision. We deny those petitions.
4
I
A
Congress enacted the Comprehensive Environmental
Response, Compensation, and Liability Act, Pub. L. No. 96-
510, 94 Stat. 2767, in 1980, and added to that regime in 1986
with the Superfund Amendments and Reauthorization Act of
1986, Pub. L. No. 99-499, 100 Stat. 1613, now codified
together at 42 U.S.C. § 9601 et seq. (“CERCLA”). CERCLA
governs the cleanup of “hazardous substances” and “pollutants
or contaminants” from the environment. 42 U.S.C. §§ 9604,
9606. The Act was Congress’s response to a series of high-
profile toxic chemical releases, including the infamous dump
of thousands of tons of chemicals in Love Canal, New York
that led to birth defects, miscarriages, and a devastated
community. See S. REP. NO. 848, 96th Cong., 2d Sess. 4–5, 8–
10 (1980); see also Niagara Mohawk Power Corp. v. Chevron
U.S.A., Inc., 596 F.3d 112, 120 & n.5 (2d Cir. 2010).
CERCLA classifies as a “hazardous substance” those
substances listed in or designated under other environmental
laws, like the Clean Water Act. There are currently over 800
such hazardous substances. 42 U.S.C. § 9601(14); 40 C.F.R.
§ 302.4 table (enumerating those substances). CERCLA also
authorizes EPA to designate as additional “hazardous
substances” those “elements, compounds, mixtures, solutions,
and substances” that, “when released into the environment[,]
may present substantial danger to the public health or welfare
or the environment[.]” 42 U.S.C. § 9602(a).
CERCLA both encourages “timely cleanup” of harmful
chemical releases and hazardous waste sites and “ensure[s] that
the costs” of cleanups are “borne by those responsible” for the
pollution. Atlantic Richfield Co. v. Christian, 140 S. Ct. 1335,
5
1345 (2020) (quoting CTS Corp. v. Waldburger, 573 U.S. 1, 4
(2014)).
CERCLA provides for two kinds of cleanups: (1) removal
actions and (2) remedial actions. 42 U.S.C. § 9601(23), (24),
(25). Removal actions are short-term measures aimed at
promptly preventing or mitigating a release of dangerous
chemicals. J.A. 447–448.
Remedial actions, on the other hand, are longer-term
efforts involving “a complex, multi-phase process” aimed at
“significantly reduc[ing] serious but not immediately life-
threatening risks” from chemical releases. J.A. 447; see 42
U.S.C. § 9601(24). Remedial actions are generally conducted
at locations listed on the “National Priorities List,” a statutorily
mandated list of sites across the country that present the
greatest danger to public health. 42 U.S.C. § 9605(a)(8)(A)–
(B); Linemaster Switch Corp. v. EPA, 938 F.2d 1299, 1301
(D.C. Cir. 1991). They are commonly known as “Superfund
sites[.]” Atlantic Richfield Co., 140 S. Ct. at 1346.
Cleanups can proceed along two statutory pathways. First,
“Section 106” cleanups are triggered only by the release of a
“hazardous substance[.]” 42 U.S.C. § 9606(a). For these
cleanups, EPA may compel responsible parties to undertake the
cleanup in the first instance. Id.
Second, “Section 104” cleanups can be triggered by the
release of either (1) a “hazardous substance” or (2) a “pollutant
or contaminant” if it “may present an imminent and substantial
danger to the public health or welfare[.]” 42 U.S.C.
§ 9604(a)(1). A “pollutant or contaminant” is defined as
including:
6
[A]ny element, substance, compound, or mixture,
including disease-causing agents, which after release
into the environment and upon exposure, ingestion,
inhalation, or assimilation into any organism, either
directly from the environment or indirectly by
ingestion through food chains, will or may reasonably
be anticipated to cause death, disease, behavioral
abnormalities, cancer, genetic mutation, physiological
malfunctions (including malfunctions in
reproduction) or physical deformations, in such
organisms or their offspring[.]
42 U.S.C. § 9601(33).
Within Section 104 cleanups, who foots the bill depends
on what needs cleaning up. When EPA leads the cleanup of
hazardous substances, the responsible polluters can later be
made to cover the costs through cost-recovery actions, so long
as the cleanups were “not inconsistent with the national
contingency plan[.]” 42 U.S.C. § 9607(a); Cooper Indus., Inc.
v. Aviall Servs., Inc., 543 U.S. 157, 161 (2004). The National
Contingency Plan, in turn, is a series of statutorily required
regulations that prescribe the methods and scope of Section 104
cleanups. 42 U.S.C. § 9605; 40 C.F.R. pt. 300.
Such refund actions are not possible for releases of
pollutants or contaminants, however. See 42 U.S.C. § 9607(a).
That means that Section 104 cleanups of pollutants or
contaminants are paid for entirely by public funds, either
(1) through the Superfund, which Congress set up to pay for
major CERCLA cleanup efforts, 42 U.S.C. § 9611(a); Ohio v.
Department of the Interior, 880 F.2d 432, 439 (D.C. Cir. 1989),
or (2) through appropriations by Congress, see GOVERNMENT
ACCOUNTABILITY OFF., GAO-15-812, SUPERFUND: TRENDS IN
7
FEDERAL FUNDING AND CLEANUP OF EPA’S NONFEDERAL
NATIONAL PRIORITIES LIST SITES 12 (2015).
B
Perfluoroalkyl and Polyfluoroalkyl Substances (“PFAS”)
is the scientific name for a broad category of human-made
chemicals. Designation of Perfluorooctanoic Acid (PFOA)
and Perfluorooctanesulfonic Acid (PFOS) as CERCLA
Hazardous Substances, 89 Fed. Reg. 39,124, 39,125 (May 8,
2024) (“Designation”). They have been used in the United
States since the 1940s to create water- and oil-resistant
products like cookware, rain-repellent clothing, and
firefighting foam. Id. at 39,126.
PFAS take hundreds of years to degrade in the
environment and take decades to be eliminated from human
bodies, earning them the title “forever chemicals[.]”
Designation, 89 Fed. Reg. at 39,126 (quotation marks omitted).
PFAS have also been linked to many adverse health effects,
including cancer, developmental effects in children, and
cardiovascular conditions. See id. at 39,145–39,146.
EPA has historically regulated two of the most common
PFAS—PFOA and PFOS—as “pollutants or contaminants”
under CERCLA. Designation, 89 Fed. Reg. at 39,153.
Several years ago, as scientific evidence of the harms
posed by PFOA and PFOS accumulated, EPA began
considering whether to designate the two chemicals as
“hazardous substances” under CERCLA. In studying the issue,
EPA published in August 2022 an Economic Assessment
delving into a quantitative cost-benefit analysis of the direct
impacts of such a designation and a qualitative analysis of the
indirect impacts. J.A. 103–111. The Assessment also
8
requested public comment on thirteen discreet issues regarding
its initial cost-benefit analyses. J.A. 118.
One month later, EPA published a Notice of Proposed
Rulemaking suggesting the designation of PFOA and PFOS as
“hazardous substances” under CERCLA. See Designation of
[PFOA] and [PFOS] as CERCLA Hazardous Substances, 87
Fed. Reg. 54,415, 54,417 (Sept. 6, 2022).
In doing so, EPA requested comments specifically on:
(1) Whether CERCLA section 102(a) precludes,
allows, or requires consideration of cost in
designation decisions, and, if so, (2) which costs and
benefits of those discussed in the EA [Economic
Assessment] should be considered, (3) whether
additional benefits and costs not identified in the EA
should be considered, (4) if indirect benefits and costs
are considered, how they should be assessed in light
of the discretion and uncertainties described above,
(5) how benefits and costs could be incorporated into
the designation decision, and (6) whether designation
would be justified if costs were to be considered in the
Agency’s designation decision.
87 Fed. Reg. at 54,423.
After receiving comments, including from Petitioners,
EPA issued its final rule in May 2024. Designation, 89 Fed.
Reg. at 39,124; e.g., J.A. 681, 687, 714. EPA used two factors
to determine that PFOA and PFOS qualified as “hazardous
substances.” First, EPA considered “the potential harm to
humans or the environment from exposure to the substance
(i.e., hazard),” and second, “how the substance potentially
moves, persists, and/or changes when in the environment (i.e.,
9
environmental fate and transport).” Designation, 89 Fed. Reg.
at 39,141. EPA concluded that both weighed in favor of
designation, crediting the significant body of research on
adverse health effects as well as the tendency of PFOA and
PFOS to remain for many years in the environment and to
bioaccumulate in human bodies. See id. at 39,143–39,148.
EPA then assumed without deciding that CERCLA
required a cost-benefit analysis of that designation.
Designation, 89 Fed. Reg. at 39,143. EPA’s evaluation of the
costs and benefits contained both “quantitative and qualitative”
considerations. Id. at 39,149. EPA published the cost-benefit
analysis in a document entitled “Regulatory Impact
Analysis[,]” and attached it to the final rule. Id. at 39,149; J.A.
368–659.
EPA’s designation of PFOA and PFOS as “hazardous
substances” has three direct impacts on regulated parties.
First, parties responsible for a release of more than one
pound of PFOA or PFOS must report that release to national
authorities, 42 U.S.C. §§ 9602(b), 9603; Waterkeeper Alliance
v. EPA, 853 F.3d 527, 531 (D.C. Cir. 2017), and, in some cases,
to local authorities and the public, 42 U.S.C. §§ 9611(g),
11004; 40 C.F.R. § 355.
Second, federal agencies selling land contaminated with
PFOA and PFOS generally must provide notice of the presence
of hazardous substances. 42 U.S.C. § 9620(h).
Third, shippers must identify and mark shipments of
PFOA and PFOS weighing more than one pound, pursuant to
the Hazardous Materials Transportation Act of 1975, 49 U.S.C.
§ 5101 et seq., 42 U.S.C. § 9656(a); 49 C.F.R. § 171.1.
10
The Designation leads to indirect impacts as well. In some
circumstances, after several more regulatory steps, EPA may
compel polluters to abate and clean up releases of PFOA or
PFOS. 42 U.S.C. § 9606. In other circumstances, the federal
government, States, and adversely affected private parties may
pursue enforcement actions to recover cleanup costs from
responsible polluters. 42 U.S.C. § 9607; see 40 C.F.R.
§§ 300.410, 300.420; 42 U.S.C. § 9606(a).
Seven interest groups for various companies that use,
transport, or discharge PFOA and PFOS in their
manufacturing, transportation, and waste management
(“Petitioners”), petitioned this court to vacate the Designation.
Petitioners challenge EPA’s (1) interpretation of “hazardous
substances” to include PFOA and PFOS as contrary to law, 5
U.S.C. § 706(2)(A); (2) cost-benefit analysis as arbitrary and
capricious, id., and in violation of Administrative Procedure
Act’s notice requirement, id. § 553; and (3) decision to regulate
in the face of uncertainties as arbitrary and capricious, id.
§ 706(2)(A).1
II
We have exclusive jurisdiction over these petitions for
review of a “regulation promulgated under” CERCLA. 42
U.S.C. § 9613(a).
1
Petitioners are the Chamber of Commerce of the United States
of America (“Chamber of Commerce”), American Chemistry
Council, American Fuel & Petrochemical Manufacturers, Associated
General Contractors of America, Inc., National Waste & Recycling
Association, Institute of Scrap Recycling Industries, d/b/a the
Recycled Materials Association, and American Forest & Paper
Association.
11
Petitioners have the jurisdictionally required Article III
associational standing. See, e.g., Students for Fair Admissions,
Inc. v. President & Fellows of Harvard College, 143 S. Ct.
2141, 2157 (2023). Petitioners have identified member
companies that use PFOA- and PFOS-containing products and
attest that they “are already seeing impacts on their overall
project expenses” in complying with the terms of CERCLA.
See Decl. of Leah Pilconis ¶¶ 19, 23–24, 27–28; Decl. of
Charles Mull ¶¶ 7, 9–12; Decl. of John M. Perkey ¶¶ 18–20;
Decl. of Anne Germain ¶ 10. Those increased expenses are
concrete injuries in fact assertedly caused by the Designation
that could be redressed by court action. In addition, the
associations’ interests in protecting companies from
CERCLA’s liability regime are germane to their missions of
promoting the financial and regulatory interests of private
industry. See Decl. of Martin Durbin ¶ 5; Decl. of Anne
Germain ¶ 3; Decl. of Leah Pilconis ¶¶ 4–5. Petitioners also
have shown that the participation of individual members is not
required to seek the equitable relief of vacatur. See Center for
Biological Diversity v. EPA, 56 F.4th 55, 67 (D.C. Cir. 2022).
In reviewing Petitioners’ contrary to law claims, we must
independently determine the “best” reading of CERCLA’s text
by “applying all relevant interpretive tools.” Loper Bright
Enters. v. Raimondo, 144 S. Ct. 2244, 2266 (2024). Our review
of Petitioners’ arbitrary and capricious claims is “deferential”
to the agency. FCC v. Prometheus Radio Project, 141 S. Ct.
1150, 1158 (2021) (“A court simply ensures that the agency
has acted within a zone of reasonableness and, in particular, has
reasonably considered the relevant issues and reasonably
explained the decision.”); see also Meritor, Inc. v. EPA, 966
F.3d 864, 869 (D.C. Cir. 2020) (“In conducting this review, we
12
afford the EPA significant deference with respect to the highly
technical issues involved.”) (formatting modified).
Finally, we must set aside a rule if the agency failed to
provide the requisite notice and comment and the petitioner has
shown prejudice. 5 U.S.C. § 553(b); Petaluma FX Partners,
LLC v. Commissioner, 792 F.3d 72, 81 (D.C. Cir. 2015).
III
Petitioners advance three challenges to the Designation.
They contend that: (1) EPA misinterpreted the term “may
present substantial danger” in CERCLA’s definition of a
hazardous substance; (2) EPA’s cost-benefit analysis provided
insufficient notice to the parties; and (3) EPA’s cost-benefit
analysis and decision to regulate in the face of uncertainty were
arbitrary and capricious.
None of those claims succeeds. The plain language of
Section 9602 allows EPA to designate as hazardous substances
chemicals like PFOA and PFOS that repeatedly have been
linked to adverse health effects in myriad peer-reviewed
studies. EPA provided adequate notice of its cost-benefit
analysis underlying the ultimate Designation through its earlier
Economic Assessment and request for comments on it. Finally,
EPA acted reasonably based on the record before it in its
calculation of costs and benefits, and in its decision to take this
regulatory step of designating PFOA and PFOS to be
hazardous substances.
A
Petitioners argue that, in interpreting the phrase “may
present substantial danger” in CERCLA’s definition of a
hazardous substance, EPA had to find that substantial danger
13
“will” occur upon release to avoid overinclusion and to comply
with the nondelegation and void-for-vagueness doctrines.
Pet’rs’ Reply Br. 14; Pet’rs’ Opening Br. at 31–32. Petitioners
are wrong as a matter of statutory text and precedent.
1
The plain statutory text refutes Petitioners’ argument.
CERCLA provides that EPA “shall” “designat[e] as hazardous
substances” those “elements, compounds, mixtures, solutions,
and substances which, when released into the environment may
present substantial danger to the public health or welfare or the
environment[.]” 42 U.S.C. § 9602(a).
In making the Designation, EPA determined that “may”
means “at a minimum, there is a possibility” that the released
substance presents a substantial danger to public health,
welfare or the environment, and that “EPA need not have
certainty” of that danger. Designation, 89 Fed. Reg. at 39,141.
Petitioners challenge EPA’s interpretation of “may[,]”
arguing that reading it to mean a “possibility” of substantial
harm lacks “fix[ed] boundaries” and is “unreasonably broad.”
Pet’rs’ Opening Br. 28–29 (secondly quoting Loper Bright, 144
S. Ct. at 2263). According to Petitioners, “may” in the statute
means that whenever a substance is released, the danger “will
be actually existing or real.” Pet’rs’ Reply Br. 12–13
(quotation marks omitted).
EPA has the best reading of the statute as a matter of text
and context.
To start, the statute straightforwardly uses “may” to refer
to the chance of harm to public health, not its certainty. The
primary meaning of “may” is one of contingency both in
14
ordinary usage and in dictionaries at the time of CERCLA’s
enactment. See May, BLACK’S LAW DICTIONARY (5th ed.
1979) (“An auxiliary verb qualifying the meaning of another
verb by expressing ability, competency, liberty, permission,
possibility, probability or contingency.”); May, BALLENTINE’S
LAW DICTIONARY 785 (3d. ed. 1969) (“Ordinarily a
permissive, rather than a mandatory, term in a statute.”); May,
OXFORD AMERICAN DICTIONARY 410 (1980) (“expressing
possibility (it may be true)”); May, WEBSTER’S THIRD NEW
INTERNATIONAL DICTIONARY 1396 (1981) (“be in some degree
likely to” as in “you [may] be right”); May, WEBSTER’S NEW
WORLD DICTIONARY 463 (2d Concise ed. 1982) (“possibility
or likelihood [it may rain]”); May, THE RANDOM HOUSE
DICTIONARY OF THE ENGLISH LANGUAGE 1189 (2d unabr. ed.
1987) (“used to express possibility” as in “[i]t may rain”).
Even more to the point, the statute says when that
contingency should be assessed, which is at the time—
“when”—the substance is “released into the environment[.]”
42 U.S.C. § 9602(a). In that way, the statute directs EPA to
forecast the future risk of harm at the time of a release.
Petitioners’ insistence that the harm must be certain to
occur at the time of release rewrites rather than interprets the
statutory text. If Congress wanted to adopt Petitioners’
preferred approach, it would have said: “substances which,
when released into the environment may will present
substantial danger to the public health or welfare or
the environment[.]” Compare Pet’rs’ Reply Br. 12–13 (“[I]f
the condition of release is satisfied, the result of substantial
danger to the public health or welfare or the environment will
be actually existing or real.”) (quotation marks omitted), with
42 U.S.C. § 9602(a) (using simply “may”).
15
Also, the dictionaries on which Petitioners rely refute their
argument, providing that the word “may” will not be treated as
a word of command or requirement “unless there is something
in [the] context” of a statute “to indicate that it was used in such
sense.” May, BLACK’S LAW DICTIONARY (5th ed. 1979); see
also May, BALLENTINE’S LAW DICTIONARY 785 (3d. ed. 1969)
(“Discretionary in its grammatical sense, but subject to
construction as mandatory where the sense of the entire context
impels such construction[.]”) (emphasis added). Missing from
Petitioners’ argument is anything in the context that impels
overriding the ordinary meaning of “may[.]”
Petitioners also forget that, in CERCLA, Congress wrote a
statute that would operate on the basis of scientific knowledge
and information about health and environmental risks.
Congress presumably knew that “[s]cientists typically speak
not of certainty, but of probability; they are trained to act on
probabilities that statistically constitute ‘certainties.’” Ethyl
Corp. v. EPA, 541 F.2d 1, 25 n.52 (D.C. Cir. 1976) (en banc);
see also id. (“Even scientific ‘facts’ are not certain, but only
theories with high probabilities of validity.”); cf. Center for
Biological Diversity v. EPA, 749 F.3d 1079, 1090 (D.C. Cir.
2014) (“[A statute] may at times require * * * action in the face
of uncertainty, lest ‘the precautionary purpose of the statute’ be
undermined.”) (quoting Ethyl Corp., 541 F.2d at 28). To
require absolute scientific certainty as to what will happen
upon every individual release of a dangerous chemical would
have been to legislatively paralyze CERCLA.
Petitioners worry that such an ordinary and contextual
reading of the text would permit EPA to categorize table salt as
a hazardous substance. Petitioners’ argument overlooks the
required finding that a release may present “substantial danger”
to public health, welfare, or the environment. 42 U.S.C.
§ 9602(a). That criterion has real bite. The risk of harm must
16
be both serious and real, not hypothesized. See Substantial,
BLACK’S LAW DICTIONARY (5th ed. 1979) (“actually existing;
real; not seeming or imaginary; not illusive; solid; true;
veritable”); Substantial, OXFORD AMERICAN DICTIONARY 683
(1980) (“of considerable amount or intensity or validity”);
Substantial, WEBSTER’S THIRD NEW INTERNATIONAL
DICTIONARY 2280 (1981) (“considerable in amount, value, or
worth”); Substantial, XVII THE OXFORD ENGLISH DICTIONARY
66 (2d ed. 1989) (“That is, or exists as, a substance; having a
real existence”); Danger, BLACK’S LAW DICTIONARY (5th ed.
1979) (“Jeopardy; exposure to loss or injury; peril.”); Danger,
OXFORD AMERICAN DICTIONARY 160 (1980) (“liability or
exposure to harm or to death”); Danger, WEBSTER’S THIRD
NEW INTERNATIONAL DICTIONARY 573 (1981) (“Harm, Injury,
Damage”) (capitalization altered); Danger, IV THE OXFORD
ENGLISH DICTIONARY 241 (2d ed. 1989) (“Liability or
exposure to harm or injury; the condition of being exposed to
the chance of evil; risk, peril.”).
More to the point, this case does not require rigidly
defining the precise boundaries of the term “substantial
danger[.]” That is because, for all their verbal debating,
Petitioners tellingly do not dispute that PFOA and PFOS
qualify as substances that may pose a substantial risk to public
health, welfare, and the environment if released. Nor could
they. The Designation cited dozens of studies showing
“[c]ollectively” that “each PFOA and PFOS individually
pose[s] a human health hazard[.]” Designation, 89 Fed. Reg.
at 39,144. The Designation spent three full pages cataloguing
just “some” of the health conditions associated with PFOA and
PFOS exposure: developmental effects including decreased
infant birth weight and effects on fetuses during pregnancy;
cardiovascular impacts like increased cholesterol in
adolescents; increased liver enzymes, which can impact liver
function; immunosuppression in adults and children; impacted
17
thyroid function; and preeclampsia and gestational
hypertension in pregnant women. Id. at 39,144–39,146.
That is not all. After reviewing toxicity assessments in
drinking water, EPA classified PFOA and PFOS as “likely to
be carcinogenic to humans[.]” Designation, 89 Fed. Reg. at
39,143 (formatting modified). The PFOA determination was
based on “evidence of kidney and testicular cancer in humans
and Leydig cell tumors, pancreatic acinar cell tumors, and
hepatocellular adenomas in rats.” Id. at 39,144. So too was the
PFOS determination based on “evidence of hepatocellular
tumors in humans and rats, pancreatic islet cell carcinomas in
male rats, and mixed but plausible evidence of bladder,
prostate, kidney, and breast cancers in humans[.]” Id.
EPA is not alone in these concerns. As the Designation
noted, the International Agency for Research on Cancer, a
subsidiary of the World Health Organization, has categorized
PFOA as “carcinogenic to humans” and PFOS as “possibly
carcinogenic to humans[.]” Designation, 89 Fed. Reg. at
39,143.
Lastly, Petitioners’ worry overlooks the political
accountability issues that would arise from a misguided
designation. In addition, Petitioners could voice objections to
an unreasonable designation in the ordinary course of notice
and comment rulemaking and, if necessary, bring suit to
challenge the final designation as contrary to law.
For all of these reasons, the phrase “may present a
substantial risk of harm” when released into the environment
18
carries its plain meaning of a scientifically possible substantial
risk of harm upon release.2
2
Petitioners next argue that the definition of “hazardous
substances” must be read more narrowly than “pollutant or
contaminant” because “CERCLA confers significantly more
authority to address ‘hazardous substances’ than ‘pollutants or
contaminants.’” Pet’rs’ Opening Br. 33. Petitioners are
mistaken.
To start, Petitioners’ insistence that courts must enforce
some inflexible hierarchy between these two categories is not
supported by anything in the statutory text. Their definitions
each require a probability of substantial danger to the public or
environmental organisms. Compare 42 U.S.C. § 9601(33)
(defining a “pollutant or contaminant” as a substance which
“will or may reasonably be anticipated to cause death, disease,
behavioral abnormalities, cancer, genetic mutation,
physiological malfunctions (including malfunctions in
reproduction) or physical deformations” in animals and
humans), and id. § 9604(a) (requiring EPA to determine that
pollutants or contaminants “may present an imminent and
2
Petitioners urge us not to afford EPA’s interpretation any
“respect” in our interpretation of Section 9602 because of (1) a 1983
notice of proposed rulemaking, which never materialized into a final
rule, proposing quantitative metrics to operationalize Section 9602,
and (2) regulations with more concrete metrics that implement
Section 9605, a part of CERCLA that does not use the word “may.”
Pet’rs’ Opening Br. 35 & n.12 (citing Loper Bright Enters., 144 S.
Ct. at 2258). Contrary to Petitioners’ contention, non-rules and
definitions in materially different regulations do not show
inconsistency with prior agency positions. More to the point, our
decision is made de novo without deference to EPA’s view.
19
substantial danger to the public health or welfare” before
initiating cleanup), with id. § 9602(a) (defining “hazardous
substances” as those which “may present substantial danger to
the public health or welfare or the environment”).
So CERCLA does not draw a comparative-harm line
between pollutants or contaminants and hazardous substances.
Instead, it creates two distinctive cleanup regimes with two
different paths for designation. The difference in how
hazardous substances and pollutants or contaminants are
treated in cleanups turns on (1) the imminence of harm and (2)
whether the risk of harm posed is uniform or could vary based
on site-specific conditions.
Pollutants or contaminants are identified for clean up on a
site-by-site basis based both on the risk of harm and—
uniquely—the harm’s “imminen[ce.]” 42 U.S.C. § 9604(a)(1);
Designation, 89 Fed. Reg. at 39,172. In addition, CERCLA
does not require EPA to promulgate any regulations or make
formal certifications to designate substances as pollutants or
contaminants, presumably because the imminence of harm may
not allow for such delays. See 42 U.S.C. § 9604(a)(1).
On the other hand, CERCLA mandates that EPA designate
hazardous substances in a single rulemaking that then applies
to all CERCLA sites. 42 U.S.C. § 9602. While Section 9602
does not explicitly call for notice and comment rulemaking,
EPA opted to do so for the PFOA and PFOS Designation, and
committed itself to further notice-and-comment rulemaking if
it were to update the Designation. Designation, 89 Fed. Reg.
at 39,174.
To the extent the statutory scheme allows substances, like
PFOA and PFOS, to originally qualify as pollutants or
contaminants and then later, be designated hazardous
20
substances based on advances in scientific knowledge, that is
the “belt and suspenders approach” that CERCLA’s text and
context straightforwardly allow. Atlantic Richfield Co., 140 S.
Ct. at 1350 n.5.
3
Finally, Petitioners contend that EPA’s reading of Section
9602 runs afoul of the nondelegation and void-for-vagueness
doctrines, and that we should reject EPA’s reading to avoid
those constitutional questions. Pet’rs’ Opening Br. 31–32.
There are no such constitutional concerns in this case.
Allowing agencies to make discretionary judgments
informed by evidence fully comports with the nondelegation
doctrine as long as “Congress has set out an ‘intelligible
principle’ to guide what it has given the agency to do.” FCC
v. Consumers’ Rsch., 145 S. Ct. 2482, 2497 (2025) (quoting
J.W. Hampton, Jr., & Co. v. United States, 276 U.S. 394, 409
(1928)). Under the “intelligible principle” test, courts require
Congress to “ma[ke] clear both the general policy that the
agency must pursue and the boundaries of its delegated
authority.” Id. (formatting modified).
Congress has laid out the “general policy” for EPA to
pursue—regulating substances that are particularly harmful to
humans and the environment by creating a cleanup and cost-
allocation scheme that puts the onus on polluters rather than
taxpayers. See 42 U.S.C. §§ 9602, 9606, 9607; cf. United
States v. E.I. Dupont De Nemours & Co., 432 F.3d 161, 169
(3d Cir. 2005) (“Congress’s decision to hold responsible
parties strictly liable for the government’s costs of responding
to hazardous waste contamination [in CERCLA] is both a
reasonable exercise of legislative authority and different in
21
kind from the unbounded delegation” found in cases that run
afoul of the nondelegation doctrine.).
Congress also has set fixed “boundaries” for the agency’s
authority and “provided sufficient standards” for courts to
police agency compliance. Consumers’ Rsch., 145 S. Ct. at
2497. For example, to categorize substances as “hazardous,”
EPA must determine that they are harmful enough to risk
“substantial danger” to human welfare or the environment. 42
U.S.C. § 9602(a).
Tying EPA’s decisions to scientific findings based on a
public health standard easily satisfies the requirement that there
be an intelligible principle to limit agency action. See, e.g.,
Consumers’ Rsch., 145 S. Ct. at 2501–2503 (finding an
intelligible principle in the Telecommunications Act’s
requirement that subsidies paid by telecommunications carriers
be enough to “contribute” to “sufficient mechanisms * * * to
preserve and advance universal service[,]” 47 U.S.C. § 254(d));
Whitman v. American Trucking Ass’ns, 531 U.S. 457, 465
(2001) (same for Clean Air Act’s delegation to EPA to set
ambient air quality standards “‘the attainment and maintenance
of which * * * are requisite to protect the public health’ with
‘an adequate margin of safety’”) (quoting 42 U.S.C.
§ 7409(b)(1)); Touby v. United States, 500 U.S. 160, 163, 165
(1991) (same for Controlled Substances Act’s authorization of
the Attorney General to temporarily add a substance to a
controlled drug schedule if doing so is “necessary to avoid an
imminent hazard to the public safety”) (quoting 21 U.S.C.
§ 811(h)(1)); see also Sessions v. Dimaya, 584 U.S. 148, 159
(2018) (“Many perfectly constitutional statutes use imprecise
terms like ‘serious potential risk’ * * * or ‘substantial risk[.]’”).
Section 9602’s plain meaning also fully comports with the
Fifth Amendment’s Due Process Clause by affording “the
22
person of ordinary intelligence a reasonable opportunity” to
predict whether a substance could be designated hazardous.
Grayned v. City of Rockford, 408 U.S. 104, 108–109 (1972).
Notice is particularly easy to find here given that PFOA and
PFOS previously have been designated under CERCLA as
“pollutant[s] or contaminant[s]” that “will or may reasonably
be anticipated to cause death, disease, behavioral
abnormalities, cancer, genetic mutation, physiological
malfunctions (including malfunctions in reproduction) or
physical deformations[.]” 42 U.S.C. § 9601(33); Designation,
89 Fed. Reg. at 39,173. That alone provided fair notice that
PFOA and PFOS might also qualify as “hazardous
substances[.]”
Beyond that, Petitioners’ members are seasoned
participants in the highly regulated area of chemical
substances’ commercial uses. They were provided ample
notice and opportunity to be heard through the notice and
comment rulemaking process that designated PFOA and PFOS
as hazardous substances, followed by judicial review. See
Village of Hoffman Ests. v. The Flipside, Hoffman Ests., Inc.,
455 U.S. 489, 498 (1982) (“[E]conomic regulation is subject to
a less strict vagueness test because * * * the regulated
enterprise may have the ability to clarify the meaning of the
regulation by its own inquiry, or by resort to an administrative
process.”).
For all those reasons, affording Section 9602’s “may
present substantial danger to the public health or welfare or the
environment” language its ordinary meaning comports fully
with the nondelegation doctrine and due process. Petitioners’
contrary to law claim fails.
23
B
The second chapter in Petitioners’ challenge focuses on
EPA’s cost-benefit analysis. Petitioners argue that EPA
(1) violated the APA’s notice requirement by failing to disclose
its Regulatory Impact Analysis until publication of the final
rule, and (2) conducted its cost-benefit analysis in an arbitrary
and capricious manner. Pet’rs’ Opening Br. 41–49.
Petitioners’ arguments do not hold up. The Regulatory
Impact Analysis was a logical outgrowth of the Economic
Assessment’s cost-benefit analysis, which was then
supplemented with data to address comments made by
Petitioners and others. EPA also reasonably explained its
quantitative analyses.3
1
First, Petitioners contend that EPA failed to provide
adequate notice of its cost-benefit analysis. While they
acknowledge that the Economic Assessment provided with the
notice of proposed rulemaking contained a cost-benefit
analysis, Petitioners argue that the final Regulatory Impact
Analysis differed such that they were no longer provided
sufficient notice. Pet’rs’ Opening Br. 43.
The APA requires that a notice of proposed rulemaking
include “either the terms or substance of the proposed rule or a
description of the subjects and issues involved,” 5 U.S.C.
§ 553(b)(3), and “give interested persons an opportunity to
3
Because we reject Petitioners’ challenges to EPA’s cost-
benefit analysis, we need not decide whether EPA was required to
consider such costs in the first instance. EPA assumed without
deciding that it had to do so, 89 Fed. Reg. at 39,143, and we do the
same.
24
participate in the rule making through submission of written
data, views, or arguments,” id. § 553(c). Notice “ensure[s] that
agency regulations are tested via exposure to diverse public
comment,” promotes fairness to impacted parties, and gives
them “an opportunity to develop evidence in the record to
support their objections[.]” International Union, United Mine
Workers v. Mine Safety & Health Admin., 626 F.3d 84, 95
(D.C. Cir. 2010) (formatting modified). This notice
requirement extends to “critical information” on which the rule
is based.