Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-22-01089/USCOURTS-caDC-22-01089-1/pdf.json

Parties Involved:
American Chemistry Council
Amicus Curiae for Petitioner
Environmental Defense Fund
Amicus Curiae for Respondent
Environmental Protection Agency
Respondent
National Wildlife Federation
Amicus Curiae for Respondent
People for the Ethical Treatment of Animals
Amicus Curiae for Petitioner
Physicians Committee For Responsible Medicine
Amicus Curiae for Petitioner
Vinyl Institute, Inc.
Petitioner

Document Text:

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued December 1, 2023 Decided July 5, 2024

No. 22-1089

VINYL INSTITUTE, INC.,

PETITIONER

v.

ENVIRONMENTAL PROTECTION AGENCY,

RESPONDENT

On Petition for Review of a Final Action

of the Environmental Protection Agency

Eric P. Gotting argued the cause for petitioner. With him 

on the briefs were Peter L. de la Cruz and Gregory A. Clark.

Jonathan R. Mook and M. Jarrad Wright were on the brief 

for amici curiae Physicians Committee for Responsible 

Medicine and People for the Ethical Treatment of Animals in 

support of petitioner.

Ryan J. Carra was on the brief for amicus curiae

American Chemistry Council in support of petitioner.

Laura J. Brown, Attorney, U.S. Department of Justice, 

argued the cause for respondent. With her on the brief was 

Todd S. Kim, Assistant Attorney General.

USCA Case #22-1089 Document #2063104 Filed: 07/05/2024 Page 1 of 26
2

Samantha Liskow and James Murphy were on the brief for 

amici curiae Environmental Defense Fund and National 

Wildlife Federation in support of respondent.

Before: HENDERSON, WALKER and PAN, Circuit Judges.

Opinion for the Court filed by Circuit Judge HENDERSON.

*

KAREN LECRAFT HENDERSON, Circuit Judge: In March 

2022, the Environmental Protection Agency (EPA) issued an 

order directed to seven chemical manufacturers/processors 

(hereafter “targeted entities”),

1 requiring them to test the 

chronic toxicity of 1,1,2-Trichloroethane (1,1,2-TCA) pursuant 

to the Toxic Substances Control Act (TSCA), 15 U.S.C. 

§§ 2601–2629. Vinyl Institute, a trade organization that

manages a consortium of the seven targeted entities, challenged 

the order based on the EPA’s failure to comply with several 

statutory requirements.2 See 15 U.S.C. § 2603. Vinyl Institute

also moved to supplement the administrative record with a 

scientific consultant’s report. See 15 U.S.C. § 2618(b).

*

 Judge Walker concurs in the judgment and concurs in the 

opinion except as to Parts II.B.4 and .5.

1 We use “targeted entities” to describe the chemical 

manufacturers/processors that are required to respond to a test 

order—including the seven targeted entities to which the March 2022 

Test Order was directed. Those seven targeted entities formed a 

consortium, managed by Vinyl Institute, to respond to the order.

2 Several amici have participated in this case. The 

Environmental Defense Fund (EDF) and National Wildlife 

Federation filed a brief in support of the EPA. The American 

Chemistry Council (ACC) filed a brief in support of Vinyl Institute, 

as did the Physicians Committee for Responsible Medicine (PCRM) 

and People for the Ethical Treatment of Animals (PETA).

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3

As detailed infra, we grant Vinyl Institute’s petition for 

review. The EPA’s non-public part of the administrative record 

is not part of “the record taken as a whole” subject to our 

heightened substantial evidence review of TSCA test orders.

15 U.S.C. § 2618(c)(1)(B)(i)(II). To the extent it relies on nonpublic portions of the administrative record, the EPA has failed 

to provide substantial evidence that meets its statutory 

mandate. We vacate and remand to the EPA to satisfy that 

mandate with “substantial evidence in the record taken as a 

whole.” Id. We also deny Vinyl Institute’s motion to 

supplement the record with scientific information it could 

have—and should have—submitted earlier. See 15 U.S.C. 

§ 2618(b). 

I. BACKGROUND

A. TSCA Testing

In 1976, the Congress became concerned that many 

chemical substances expose humans and the environment to 

“an unreasonable risk of injury to health or the environment.”

15 U.S.C. § 2601(a)(2). In order to “prevent unreasonable risks 

of injury,” the Congress enacted the TSCA, Pub. L. No. 94-

469, 90 Stat. 2003 (1976) (codified at 15 U.S.C. §§ 2601–

2629). S. REP. NO. 94-698, at 1 (1976). Under the TSCA,

entities that manufacture and process such chemicals must

develop and maintain adequate data. 15 U.S.C. § 2601(b) 

(1976). The statute requires the entities to test substances to 

determine whether their manufacture, distribution, processing 

or use “does or does not present an unreasonable risk of injury 

to health or the environment.” Id. § 2603(a)(2) (1976). Before 

promulgating its “testing” rule, however, the EPA is first 

required to find that (1) the chemical “may present an 

unreasonable risk of injury to health or the environment”; (2) 

the EPA lacks sufficient data and experience to determine or 

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predict the chemical’s effects; and (3) testing “is necessary to 

develop such data.” Id. § 2603(a)(1)(A) (1976) (emphasis 

added). Once the EPA determines that a chemical substance 

poses an unreasonable risk, the TSCA authorizes it to regulate

the substance. See id. § 2605 (1976).3

By the 2010s, the Congress expressed “persistent 

concerns” regarding the EPA’s slow pace in implementing the 

TSCA, H.R. REP. NO. 114-176, at 12 (2015), and so—

recognizing shortcomings based on statutory structure, court 

decisions and the EPA’s interpretation of those decisions—it 

revised the statute via the 2016 Amendments. S. REP. NO. 114-

67, at 2 (2015); 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. §§ 2601–2629). The 2016 Amendments 

require the EPA to designate chemicals as “high-priority” or 

“low-priority.” 15 U.S.C. § 2605(b)(1). The EPA then 

conducts a risk evaluation for each high-priority chemical to 

determine whether it presents an “unreasonable risk of injury 

to health or the environment.” Id. § 2605(b)(3)–(4). If it 

concludes the chemical presents an unreasonable risk of injury, 

it can then regulate the chemical through a rulemaking. Id. 

§ 2605(a). The 2016 Amendments instruct the EPA to 

complete high-priority risk evaluations within 3 years. Id. 

§ 2605(b)(4)(G); H.R. REP. NO. 114-176, at 25. Significant to 

this litigation, they also supplement the EPA’s existing test rule 

authority—codified at Section 2603(a)(1)—with “[a]dditional 

testing authority” under Section 2603(a)(2). That authority 

allows the EPA to impose a testing requirement on targeted 

entities via “rule, order, or consent agreement” and applies 

whenever new information “is necessary” in order to perform 

a risk evaluation. 15 U.S.C. § 2603(a)(2); H.R. REP. NO. 114-

3 The post-2016 TSCA retains each of these requirements. See

15 U.S.C. §§ 2601(b), 2603(a)(1), 2605(a).

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176, at 22–23. The EPA may choose whether to proceed under 

Section 2603(a)(1) or (a)(2). See 15 U.S.C. § 2603(a)(2) (“In 

addition to the authority provided under paragraph (1), the 

Administrator may [develop information] by rule, order, or 

consent agreement . . . .” (emphasis added)).

Before the EPA can compel targeted entities to test—“by 

rule, order, or consent agreement”—under its Section

2603(a)(2) authority, it must take several steps. Id. First, it must 

provide a Statement of Need that (1) identifies “the need for the 

new information”; (2) describes how “reasonably available” 

information informs the EPA’s decision; (3) “explain[s] the 

basis for any decision that requires the use of vertebrate 

animals”; and (4) if applicable, explains its rationale for 

issuance of a test order instead of a rule or consent agreement. 

Id. § 2603(a)(3). Next, the EPA must address how a screening 

test or other available information supports additional testing. 

Id. § 2603(a)(4). A rule, order or consent agreement must 

identify the chemical substance to be tested and the protocols 

and methodologies for developing the required information. Id. 

§ 2603(b)(1). In determining protocols and methodologies, it 

must consider the costs as well as the reasonably foreseeable 

availability of facilities to perform the testing. Id. In addition 

to explaining the basis for vertebrate testing in its Statement of 

Need, the EPA must consider “existing information” such as 

toxicity, computational toxicology, bioinformatics and highthroughput screening methods. Id. § 2603(h)(1)(A).

4 Finally, 

4

 “High-throughput screening” is a “[p]rocess that allows 

automated testing of large numbers of chemical and/or biological 

compounds for a specific biological target.” High-Throughput 

Toxicology, EPA, https://perma.cc/V3TE-ZH2P. The EPA refers to 

toxicity information, computational toxicology, bioinformatics and 

high-throughput screening methods as New Approach 

Methodologies (NAMs). Strategic Plan to Promote the Development 

and Implementation of Alternative Test Methods Within the TSCA 

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the EPA must conduct each risk evaluation consistent with the 

“best available science” and its decision must be based on the 

“weight of the scientific evidence.” Id. § 2625(h), (i); see also 

40 C.F.R. § 702.33. 

B. 1,1,2-Trichloroethane

This case involves the EPA’s risk evaluation of 1,1,2-

TCA, a colorless, sweet-smelling liquid used in chemical

production. See Final Scope of the Risk Evaluation for 1,1,2-

TCA, EPA Doc. # EPA-740-R-20-003, at 11 (Aug. 2020), 

https://perma.cc/N78Z-QGX5 (Final Scope Doc.). The EPA 

established a list of twenty high-priority substances, including 

1,1,2-TCA. High-Priority Substance Designations Under the 

TSCA, 84 Fed. Reg. 71924, 71934 (Dec. 30, 2019). This 

designation triggered TSCA’s Section 2605(b)(3)–(4) risk 

evaluation. See id. (“[A] final designation as a High-Priority 

Substance initiates the risk evaluation for the chemical 

substance.”). 

Following 1,1,2-TCA’s high-priority designation, the EPA 

issued a lengthy 1,1,2-TCA final scope document that outlined 

hazards, exposures, conditions of use and potentially exposed 

sub-populations. Final Scope Doc. Next, the EPA issued a test 

order under its Section 2603(a)(2) authority. Order Under 

Section 4(a)(2) of the Toxic Substances Control Act, EPA-HQOPPT-2018-0421 (Jan. 14, 2021), https://perma.cc/LW7ZAZX5 (January 2021 Test Order). The test order required a

chronic toxicity exposure study of aquatic benthic midges and 

occupational studies on inhalation and dermal exposure to 

humans and included a Statement of Need. Id. at 2–8. The 

Program, EPA Doc. # EPA-740-R1-8004, at 6 (June 22, 2018), 

https://perma.cc/4NY3-93GG; see also List of Alternative Test 

Methods and Strategies (or New Approach Methodologies [NAMs]), 

EPA (Feb. 4, 2021), https://perma.cc/4GYA-66D8. 

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targeted entities can use various options to respond, including 

developing the information via testing (Option 1) or submitting 

existing studies and other relevant information to the EPA 

(Option 2). Id. at 13–16. 

In March 2022, the EPA issued a second 1,1,2-TCA test 

order that Vinyl Institute challenges here. Order Under Section 

4(a)(2) of the Toxic Substances Control Act, EPA-HQ-OPPT2018-0421 (March 24, 2022), https://perma.cc/KQ57-LPFA

(March 2022 Test Order).

5 The test order requires reproductive 

testing of earthworms and birds for chronic toxicity. Id. at 6. 

The avian reproduction test involves administering 1,1,2-TCA 

continuously to the northern bobwhite quail’s diet. See 

Ecological Effects Test Guidelines: OCSPP 850.2300 Avian 

Reproduction Test, EPA-HQ-OPPT-2009-0154-0012 (Jan. 

2012), https://perma.cc/5W8L-XEQJ. The EPA provided a 

Statement of Need explaining how: it lacks data on 1,1,2-

TCA’s chronic toxicity to earthworms and birds; reasonably 

available information does not close the data gap; a test order 

allows the EPA to gather the needed information more quickly 

than the rulemaking and consent agreement routes do; and no 

new approach methodologies (NAMs) can replace the ordered 

vertebrate testing for chronic toxicity. March 2022 Test Order

at 5–9. The test order acknowledged a previous acute toxicity 

study regarding chicken embryos—the 1979 Elovaara study—

but explained that it failed to fill the chronic toxicity data gap. 

Id. at 9. The EPA also cited data on potential vertebrate 

exposure to 1,1,2-TCA from the U.S. Geological Survey’s 

(USGS) National Water Quality Monitoring Council. Id. The 

test order gave the seven targeted entities multiple response 

options, including developing the information by testing 

5

 The EPA amended the March 2022 Test Order in April 2022 

to correct an error and again in August 2022 to remove two targeted 

entities. 

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(Option 1) or submitting existing studies and other relevant 

information “that [they] believe the EPA has not considered” 

(Option 2). Id. at 11.

C. Procedural Posture

On June 2, 2022, Vinyl Institute responded to the March 

2022 Test Order on behalf of the seven targeted entities by 

selecting Option 1—developing information by conducting 

both the avian and earthworm reproduction tests. But 

previously, on May 23, Vinyl Institute had timely petitioned 

the Court for review of the March 2022 Test Order. See 15 

U.S.C. § 2618(a). Vinyl Institute challenges only the avian 

reproduction test. In August 2022, Vinyl Institute moved to 

supplement the administrative record pursuant to 15 U.S.C. 

§ 2618(b) with a report prepared by scientific consultant 

Stantec (Stantec Report). A motions panel referred the motion

to us. 

We have jurisdiction of the petition for review under 15 

U.S.C. § 2618(a)(1)(A) and of the Section 2618(b) motion 

under 15 U.S.C. § 2618(b).

II. SECTION 2603(A)(2) TEST ORDER REQUIREMENTS 

A. Standard of Review 

The 2016 Amendments instruct us to “hold unlawful and 

set aside” a test order if it “is not supported by substantial 

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

§ 2618(c)(1)(B)(i)(II). Our interpretation of this standard of 

review presents an issue of first impression.

Under the pre-2016 TSCA, as noted supra, the EPA could 

compel manufacturers to test via a rulemaking only, 15 U.S.C. 

§ 2603 (1976), and judicial review of a TSCA rule weighed 

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“substantial evidence in the rulemaking record . . . taken as a 

whole.” 15 U.S.C. § 2618(c)(1)(B)(i) (1976) (emphasis added);

see also Env’t Def. Fund, Inc. v. EPA, 636 F.2d 1267, 1277 

(D.C. Cir. 1980). Section 2618 defined “rulemaking record” as 

the rule under review, any required findings and any oral 

transcripts or written submissions made during the rule’s 

promulgation. 15 U.S.C. § 2618(a)(3) (1976). In Chemical 

Manufacturers Association v. EPA (CMA), we determined that 

the TSCA’s “substantial evidence” review of a test rule is 

“more searching” and “demanding” than the APA’s substantial 

evidence review. 859 F.2d 977, 992 (D.C. Cir. 1988) (quotation 

omitted). The Congress “contemplated that the TSCA standard 

should be viewed as a distinct standard.” Id. at 991. And the 

legislative history indicated Congressional intent to make the 

TSCA substantial evidence standard stricter than its APA 

counterpart. Id. at 991–92 (citing H.R. REP. No. 94-1679, at 96 

(1976) (Conf. Rep.)).

The 2016 Amendments granted the EPA additional 

authority regarding test orders, 15 U.S.C. § 2603(a)(2), and 

again included a judicial review provision, 15 U.S.C. 

§ 2618(c)(1)(B)(i)(II). A court will “hold unlawful and set 

aside” a test order if it “finds that the order is not supported by 

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

§ 2618(c)(1)(B)(i)(II). The only difference between the review 

of test orders and the review of Section 2603(a)(1) test rules

(now codified at 15 U.S.C. § 2618(c)(1)(B)(i)(I)) is the 

omission of “rulemaking” from the former.6 Thus, as it did with 

the test rule standard at issue in CMA, the Congress explicitly 

rejected the application of the APA’s substantial evidence 

standard and drafted an alternate standard for test order review. 

6 The 2016 Amendments made one other minor adjustment to 

the judicial review provision by deleting the statutory definition of 

“rulemaking record” in 15 U.S.C. § 2618(a)(3) (1976). 

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See CMA, 859 F.2d at 991–92; 15 U.S.C. 

§ 2618(c)(1)(B)(i)(II). Test order review, then, is distinct from 

APA review. See CMA, 859 F.2d at 991. In CMA, we described 

the required review of the test rule being challenged there as 

“fairly rigorous” and more “searching” than the APA standard. 

Id. at 992. The same standard applies here. But CMA did not 

address what documents constitute the record “taken as a 

whole,” the issue we must now decide in the test order context.

The record of course includes the test order itself—

including the statutorily required Statement of Need. See 15 

U.S.C. § 2603(a)(3). But the parties dispute whether the nonpublic portion of the administrative record—provided to Vinyl

Institute only after it filed suit—is to be considered part of the 

record. The non-public portion of the 1,1,2-TCA 

administrative record contains several spreadsheets addressing 

the applicability of NAMs to high-priority substances, studies 

considered by the EPA, estimates of testing costs and burdens 

and the 1979 Elovaara Study. There was—and is—no public 

access to this portion of the record. The EPA argues that we 

should consider facts and data in the entire administrative 

record—both public and internal—because the “standard of 

review is based on the record as a whole, not just the Test 

Order.” EPA Br. 32; see Oral Arg. Tr. 21:16–23:24. Vinyl

Institute protests that the EPA’s use of the non-public portion 

constitutes prohibited post hoc reasoning because the EPA 

failed to provide all of the data on which it relied. 

We agree with Vinyl Institute that “the record taken as a 

whole” cannot lawfully include those non-public portions that 

the EPA did not reveal until this litigation began. First, the 

EPA’s reliance on an administrative record that keeps portions 

thereof from the public is in tension with a bedrock principle 

of administrative law: agency action is upheld only “upon the 

validity of the grounds upon which the [agency] itself based its 

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action.” SEC v. Chenery Corp. (Chenery I), 318 U.S. 80, 88 

(1943); see also Kevin M. Stack, The Constitutional 

Foundations of Chenery, 116 YALE L.J. 952, 992–98 (2007) 

(Chenery I’s reason-giving requirement increases democratic 

accountability and reduces arbitrariness). When the EPA 

requires testing via rulemaking, the court reviews the 

“rulemaking record”—information fully available to the 

public—for substantial evidence. 15 U.S.C. 

§ 2618(c)(1)(B)(i)(I). And when the EPA chooses the test order 

alternative, as it did with the March 2022 Test Order, it cannot 

rely on a non-public reason to satisfy its Section 2603 burden. 

See Algonquin Gas Transmission Co. v. FERC, 948 F.2d 1305, 

1316 (D.C. Cir. 1991) (declining to consider FERC’s record 

evidence that “was nowhere considered in either of the 

Commission’s orders below”). Section 2618(c)(1)(B)(i)(II)’s 

review of the record “taken as a whole” does not permit the 

EPA to rely on undisclosed supporting data. Cf. Motor Vehicle 

Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 50 

(1983) (“It is well-established that an agency’s action must be 

upheld, if at all, on the basis articulated by the agency itself.”).

Second, the text offers no support for the EPA’s claim that 

the statute’s “record taken as a whole” language allows us to 

review the entire record—whether or not portions thereof have 

been made public. EPA Br. 38. It is well established that we 

may review agency action only on “the grounds upon which 

the [agency] itself based its action.” Chenery I, 318 U.S. at 88. 

The Congress could not have intended that the record “taken as 

a whole” encompasses non-public information that the EPA 

failed to disclose at the time of its final action. We do not 

countenance an agency’s reliance on “a body of private law.” 

Tax Analysts v. I.R.S., 117 F.3d 607, 619 (D.C. Cir. 1997). 

The agency’s counterarguments lack merit. It claims Vinyl

Institute could have asked to see any undisclosed portion of the 

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administrative record before initiating litigation. But that 

option—if it existed—does not relieve the EPA of its statutory 

burden to satisfy Section 2603’s requirements with substantial 

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

§ 2618(c)(1)(B)(i)(II).7 The EPA cannot rely on the non-public 

administrative record to meet its evidentiary burden.

B. The EPA’s Section 2603 Burden 

Having set forth the substantial evidence standard 

applicable to TSCA test orders, we now review whether the

EPA provided substantial evidence to meet its Section 2603

burden regarding six discrete matters.

1. Need for New Information

As part of the required Statement of Need, the EPA “shall 

identify the need for the new information.” 15 U.S.C. 

§ 2603(a)(3). Need is determined by the scope of the EPA’s 

risk evaluation of a given chemical as it is required to “integrate 

7 Defining “the record” to include only the public portions 

thereof does not limit the court’s review to the test order only. We 

also consider other publicly available documents relied on by the 

EPA. The EPA’s classification of 1,1,2-TCA as a high-priority 

chemical substance is part of “the record.” See 84 Fed. Reg. at 71934. 

After its initial risk evaluation, the EPA must publish a final scope 

document addressing hazards, exposures, conditions of use and 

potential exposed sub-populations that it intends to weigh in 

evaluating high-priority substances. 15 U.S.C. § 2605(b)(4)(D). The 

119-page final scope document for 1,1,2-TCA is also part of “the 

record.” See Final Scope Doc. Indeed, the March 2022 Test Order 

incorporates the final scope document by reference. March 2022 Test 

Order at 6, 21. The January 2021 Test Order for 1,1,2-TCA is also 

publicly available and cited in the March 2022 Test Order. Id. at 5, 

21. The EPA can—and does—rely on all of these publicly available 

documents as part of the record. 

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and assess available information on hazards and exposures.” 

Id. § 2605(b)(4)(F)(i). The Statement of Need also requires the 

EPA to “describe how information reasonably available to the 

Administrator was used to inform the decision to require new 

information.” Id. § 2603(a)(3). We uphold its identification of 

a need for, and description of, information only if it provides

substantial evidence therefor within the meaning of Section 

2618(c)(1)(B)(i)(II). 

Based on 1,1,2-TCA’s final scope document, the EPA 

determined that it needed to assess environmental hazards and 

risks to aquatic and terrestrial plants, invertebrates and 

vertebrates. March 2022 Test Order at 7. The test order 

explained how it evaluated data for 1,1,2-TCA and analogous 

chemicals (analogues). Id. It used its Analog Identification 

Methodology (AIM) software to identify seven analogues to 

1,1,2-TCA. Id. It searched for hazard data pertaining to 1,1,2-

TCA and the analogues in its ECOTOX Knowledgebase and 

from information submitted to it via the TSCA and other 

programs. Id. The March 2022 Test Order noted the earlier 

January 2021 Test Order that addressed aquatic data gaps. Id.

After assessing this information, the EPA identified 1,1,2-TCA 

acute exposure data for soil invertebrates, mammals and birds 

as well as chronic exposure data for mammals and vegetation. 

Id. at 7–8. But it failed to identify chronic exposure data—for 

1,1,2-TCA or the analogues—for soil invertebrates and birds. 

Id. Monitoring data from USGS’ National Water Quality 

Monitoring Council identified 1,1,2-TCA in media, including 

ground water, sediment, soil and surface water, to which birds 

can be exposed. Id. at 9. Accordingly, the EPA issued the 

March 2022 Test Order to close the chronic toxicity data gap. 

Id. at 7. 

Nonetheless, it failed to provide substantial evidence of 

how the reasonably available information informed the 

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decision to require new avian testing. In Table 1, the EPA 

acknowledged hazard data for acute bird exposure to 1,1,2-

TCA and 1,1,1-TCA (an analogue). Id. at 8 tbl.1. The test order 

described the 1,1,2-TCA acute exposure data, captured in the 

1979 Elovaara egg injection study. Id. at 9. The EPA 

adequately explained that its acute toxicity finding in chick 

embryos indicated the need for additional data on “potential 

effect following chronic dietary exposure.” Id. Its reference to 

this one study only, however, fails our “searching” substantial 

evidence review. See CMA, 859 F.2d at 991. The EPA failed to 

explain or even identify the 1,1,1-TCA bird acute exposure 

study in the test order itself. March 2022 Test Order at 8. It also 

noted the 1,1,2-TCA mammalian chronic exposure data in 

Table 1 but failed to identify the study. Id. Nor did it explain 

whether mammalian chronic exposure data can be extrapolated 

to birds. Id. Yet in a declaration submitted only to us, an EPA 

official explains that “toxicologists do not extrapolate 

mammalian toxicity data to birds because there are significant 

differences between the anatomy and physiology of birds and 

mammals and uncertainty in comparisons increases with larger 

taxonomic distances.” J.A. 114. The EPA should have 

explained why it could not extrapolate mammalian chronic 

exposure data to avian chronic exposure in its Statement of 

Need description of reasonably available information. 

Identifying close but ultimately inapplicable studies and 

explaining, in the record, why it could not extrapolate other

potentially relevant findings could constitute substantial 

evidence of “how information reasonably available to the 

Administrator was used to inform the decision to require new 

information.” 15 U.S.C. § 2603(a)(3).

Again, we find the EPA’s counterarguments unavailing. 

Another provision of the TSCA requires the EPA to publish “a 

list of the studies considered by the Administrator in carrying 

out each such risk evaluation, along with the results of those 

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studies.” Id. § 2625(j)(4). According to the EPA, the Congress 

would have written a similar requirement into Section 2603 if 

it had wanted the agency to include all studies it either 

reviewed or rejected in the Statement of Need, but that 

requirement would have contradicted the Congress’ intent to 

expedite TSCA risk evaluations. See S. REP. NO. 114-67, at 10. 

Although the EPA need not list every study in the test order’s 

Statement of Need to satisfy our substantial evidence review, it 

must provide substantial evidence of the need for new 

information as well as an assessment of available information.

15 U.S.C. § 2603(a)(3).8

2. Basis for Vertebrate Testing 

The Statement of Need also requires the EPA to “explain 

the basis for any decision that requires the use of vertebrate 

animals.” 15 U.S.C. § 2603(a)(3). Before requiring vertebrate 

testing, the EPA must consider “reasonably available existing 

information,” including new approach methodologies (NAMs)

of toxicity information, computational toxicology,

bioinformatics and high-throughput screening methods and 

their prediction models. Id. § 2603(h)(1)(A). By requiring the 

agency to consider NAMs, the Congress intended the EPA to 

reduce its use of vertebrate animal testing. Id. § 2603(h)(1). 

As explained in the March 2022 Test Order, the EPA 

considered computational toxicology and bioinformatics in

determining a need for new information. March 2022 Test 

Order at 8. In particular, it applied the AIM tool to identify 

8 One of the non-public administrative record’s data 

spreadsheets does identify 1,1,2-TCA studies the EPA considered. 

J.A. 37–41 (referencing studies reflected in Table 1 of the March 

2022 Test Order at 8); see also EPA Br. 32. But we cannot consider 

these data spreadsheets because they were not publicly available 

when the EPA issued its March 2022 Test Order.

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16

analogues. Id. It concluded, however, that “[r]easonably 

available data, computational toxicology, or high-throughput 

screening methods and predictions models are not available 

and/or cannot be used to address” 1,1,2-TCA’s chronic toxicity 

to birds. Id. And “[n]o approved or readily available [NAMs]

were identified that could be used.” Id.

Under our searching substantial evidence review, these

conclusory statements fail to explain the basis for vertebrate 

testing or to demonstrate adequately the EPA’s consideration 

of NAMs. The non-public administrative record reflects that 

the EPA did consider several NAMs, including ChemACE, 

ECOSAR and OncoLogic. J.A. 33 (Data Gap Spreadsheet). 

And in its brief, the EPA succinctly explains why the NAMs it 

considered were inapplicable. For example, ChemACE did not 

identify any analogous chemicals to 1,1,2-TCA; ECOSAR 

predicted hazardsfor aquatic species, not birds; and OncoLogic 

addressed cancer in humans, not birds. EPA Br. 28. As part of 

its Statement of Need, the EPA should (1) indicate that it 

considered NAMs before requiring vertebrate testing and (2) 

explain why vertebrate testing is needed. Although the nonpublic administrative record and the EPA’s brief cover these 

matters, they are not part of the record subject to our review for 

substantial evidence. See supra Section II.A.

3. Tiered Screening and Testing 

The TSCA imposes an additional requirement when the 

EPA considers whether to conduct additional testing of a 

specific chemical. If “information available to the 

Administrator justifies more advanced testing . . . without first 

conducting screening-level testing,” the EPA can proceed with 

advanced testing. 15 U.S.C. § 2603(a)(4). Otherwise, the EPA 

“shall employ a tiered screening and testing process.” Id. It 

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does so by considering “results of screening-level tests or

assessments of available information.” Id. (emphasis added). 

Vinyl Institute protests that the EPA did not conduct 

screening tests. Vinyl Institute construes the disjunctive “or” to 

require that the EPA use both screening-level tests and 

assessments of available information. It relies on the 

justification clause, through which the EPA can bypass the 

tiered screening and testing process.

9 See 15 U.S.C. 

§ 2603(a)(4). According to Vinyl Institute, the Congress would 

not have included the justification clause if the EPA could 

choose between screening tests or assessing available 

information to complete the tiered screening and testing 

process. We disagree. Section 2603(a)(4) instructs the EPA to 

first consider if available information justifies bypassing the 

tiered screening and testing process altogether. If the EPA does 

not find support for a bypass—a high standard—it “shall

employ a tiered screening or testing process.” Id. (emphasis 

added). 

The EPA claims that it conducted the tiered screening and 

testing process by assessing available information. It searched 

peer-reviewed literature databases for studies involving 1,1,2-

TCA. March 2022 Test Order at 6–7. It also searched “gray 

literature” such as technical reports, reference books and 

dissertations. Id. at 7. It evaluated public comments submitted 

to the agency regarding 1,1,2-TCA. Id. Then, as discussed, it 

identified analogues, searched for toxicity studies and 

considered relevant NAMs. See supra Subsections II.B.1 and 

2. It thus assessed available information before ordering the 

9 The justification clause allows the EPA to bypass the tiered 

screening and testing process if available information “justifies more 

advanced testing . . . without first conducting screening-level 

testing.” 15 U.S.C. § 2603(a)(4).

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seven targeted entities to conduct the avian chronic toxicity 

testing. 

Nonetheless, the record lacks substantial evidence that the 

EPA adequately assessed available information. As discussed 

supra, the EPA failed to identify and explain sufficiently the 

relevant available studies or to address the (in)applicability of 

any NAMs. See 15 U.S.C. § 2603(a)(3). The assessment of 

available information in the Section 2603(a)(4) tiered 

screening and testing process thus rises and falls with 

Statement of Need requirements in Section 2603(a)(3). 

4. Order versus Rule or Consent Agreement

The EPA may exercise its new “[a]dditional testing 

authority” “by rule, order, or consent agreement.” 15 U.S.C. 

§ 2603(a)(2). If it chooses the test order route, the Statement of 

Need must address “why issuance of an order is warranted 

instead of promulgating a rule or entering into a consent 

agreement.” Id. § 2603(a)(3). 

The EPA explained that the March 2022 Test Order will 

allow it “to obtain the needed information more quickly than if 

the EPA were to issue a . . . rulemaking or consent agreement.” 

March 2022 Test Order at 8. Vinyl Institute believes “[t]his is 

not an adequate explanation” but it points to no statutory 

language barring the EPA from choosing the test order route 

based on that route’s comparative speed. Vinyl Institute Br. 37; 

see also ACC Amicus Br. 4–5. Indeed, the 2016 Amendments’ 

legislative history expressly discussed reducing barriers to 

EPA’s testing authority. See H.R. REP. NO. 114-176, at 22–23; 

S. REP. NO. 114-67, at 10. In 2022, an EPA official testified 

before the Congress that many chemical risk evaluations have 

fallen behind schedule and would not be completed by their 

2023 deadlines. Testimony of Michal Ilana Freedhoff before 

the Senate Committee on the Environment and Public Works, 

USCA Case #22-1089 Document #2063104 Filed: 07/05/2024 Page 18 of 26
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at 6–7 (June 22, 2022), https://perma.cc/H7WQ-MEHJ; see 15 

U.S.C. § 2605(b)(4)(G) (requiring that risk evaluations be

completed within three years, subject to one six-month 

extension); 84 Fed. Reg. at 71,925 (designating 1,1,2-TCA in 

December 2019, with a June 2023 deadline). The EPA’s choice 

to use the more expeditious test order method makes sense to 

us—the agency is, after all, behind schedule.10 The EPA 

provided a sufficient explanation for why it issued a test order 

instead of a rulemaking or consent agreement. 

5. Demonstration of Bird Exposure to 1,1,2-TCA

Vinyl Institute argues the EPA must provide some 

demonstration of avian exposure to 1,1,2-TCA at potentially 

toxic levels before issuing a test order. Granted, Section 

2625(k) requires the agency to take hazard and exposure 

information into consideration. But Section 2603 does not 

instruct the EPA to address exposure in the test order. Vinyl 

Institute’s argument reverses the TSCA’s allocation of 

burdens. The development of chemical effects information 

“should be the responsibility of those who manufacture and 

those who process such chemical substances and mixtures.” 15 

U.S.C. § 2601(b)(1). The TSCA imposes many burdens on the 

EPA before it can issue a test order under Section 2603(a)(2)—

including issuing a Statement of Need, implementing a tiered 

10 Amici PCRM and PETA argue that the Congress listed “rule, 

order, or consent agreement” in that order to indicate a hierarchy. 

PCRM/PETA Amicus Br. 9–10. Under their interpretation, the EPA 

must first consider rulemaking, then test orders and finally consent 

agreements. Id. The text does not support their reading. The 

Congress’ use of the disjunctive “or” suggests that all three options—

rule, order or consent agreement—are equally available. See Encino 

Motorcars, LLC v. Navarro, 584 U.S. 79, 87 (2018) (“or” is “almost 

always disjunctive” unless statutory context overcomes its ordinary 

meaning). 

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screening and testing process and considering costs and 

availability of facilities—but targeted entities have the ultimate 

burden to test 1,1,2-TCA for avian chronic toxicity.

After instituting a TSCA risk evaluation but before issuing 

a Section 2603(a)(2) test requirement, the EPA must 

“determine[] that the information is necessary” “to perform a 

risk evaluation.” Id. § 2603(a)(2)(A). The 1,1,2-TCA risk 

evaluation requires an assessment of hazard and risk to plants, 

invertebrates and vertebrates—including birds. March 2022 

Test Order at 7. After considering the avian acute toxicity data 

from the 1979 Elovaara study and the USGS’ monitoring data 

demonstrating potential exposure to birds, the EPA reasonably 

determined that it needed avian chronic toxicity data. Id. at 8–

9. Substantial evidence in the record indicates that avian 

chronic toxicity information is necessary for the EPA to 

complete its 1,1,2-TCA risk evaluation. It did not need to 

demonstrate a certain level of exposure before issuing the test 

order.

11

6. Costs and Reasonable Availability 

A test order must identify the chemical substance for 

which testing is required, the protocols and methodologies for 

11 The parties dispute how the exposure standard set forth in 

CMA applies here. Under the original TSCA test rule provision, the 

EPA had to find that a chemical “may present an unreasonable risk 

of injury to health or the environment” before issuing a test rule. 15 

U.S.C. § 2603(a)(1)(A) (1976); see also id. § 2603(a)(1)(A)(i)(I)

(2016). In CMA, we concluded that the EPA must have a “more-thantheoretical basis for inferring the existence of exposure.” 859 F.2d at 

988. Because the EPA issued the March 2022 Test Order under 

Section 2603(a)(2)’s “[a]dditional testing authority,” however, 

CMA’s interpretation of Section 2603(a)(1)’s unreasonable risk 

requirement is inapplicable. 

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testing and the period needed to complete the testing. 15 U.S.C. 

§ 2603(b)(1). “In determining the protocols and methodologies 

and period to be included,” the EPA’s “considerations shall 

include the relative costs of the various test protocols and 

methodologies . . . and the reasonably foreseeable availability 

of the facilities and personnel needed to perform the testing.” 

Id. According to the EPA, this provision imposes two distinct 

requirements: it must identify the chemical substance, 

protocols and time period in the test order but it must simply 

consider costs and availability of facilities, presumably pre-test 

order. It submits that it did consider costs, demonstrated by a 

spreadsheet in its non-public administrative record that 

estimated avian reproduction testing costs at $288,283. Vinyl

Institute insists that the EPA had to identify the relative costs 

of, and the availability of facilities for, the avian reproduction 

tests in the test order itself. 

Again, we review the “the record taken as a whole” for 

substantial evidence. 15 U.S.C. § 2618(c)(1)(B)(i)(II). The 

EPA did not publish the cost estimate spreadsheet at the time it 

issued the March 2022 Test Order and it is therefore not in the 

record “taken as a whole.” See supra Section II.A. To satisfy 

Section 2603(b)(1), the EPA must provide substantial evidence 

that it considered the relative costs of the protocols and the 

reasonably foreseeable availability of facilities and personnel

to conduct the testing. 15 U.S.C. §§ 2603(b)(1); 

2618(c)(1)(B)(i)(II).12 The EPA did not provide substantial 

evidence of these factors—again, in the record as the TSCA 

defines it—that is, “taken as a whole.”

12 The EPA gave no consideration to the reasonably foreseeable 

availability of facilities and personnel in either the record under 

review or the non-public portion of the administrative record. See 15 

U.S.C. § 2603(b)(1).

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III. SECTION 2618(B) MOTION

Under TSCA Section 2618(b), a party can move for leave 

to “make additional oral submissions or written presentations” 

for the EPA’s consideration. A movant must show “to the 

satisfaction of the court” that the additional information (1) 

“would be material” and (2) “there were reasonable grounds 

for the submissions and [for] failure to make such submissions 

and presentations in the proceeding before the Administrator.” 

15 U.S.C. § 2618(b) (emphasis added). Once the movant 

makes these showings, the court “may order the Administrator 

to provide additional opportunity” to the movant to submit the 

information. Id. Although no court has yet reviewed a TSCA 

Section 2618(b) motion, other regulatory statutes contain 

similar materiality and reasonable grounds tests. See, e.g., 15 

U.S.C. § 45(c) (Federal Trade Commission Act); 16 U.S.C. 

§ 825l(b) (Federal Power Act); 29 U.S.C. § 160(e) (National 

Labor Relations Act); 33 U.S.C. § 1369(c) (Clean Water Act). 

The Supreme Court has endorsed the materiality and 

reasonable grounds requirements because they ensure that such 

motions are “used only for proper purposes, and not abused by 

resort to [them] as a mere instrument of delay.” Southport 

Petroleum Co. v. NLRB, 315 U.S. 100, 104 (1942). Vinyl 

Institute seeks to admit the Stantec Report pursuant to Section 

2618(b). 

A. Extent of “Proceeding” 

The movant must demonstrate “reasonable grounds” for 

failing to submit the additional evidence “in the proceeding 

before the Administrator.” 15 U.S.C. § 2618(b). The parties 

disagree on the date the proceeding ended. Vinyl Institute 

claims it ended upon issuance of the March 2022 Test Order.

The EPA argues the proceeding continued after issuance

because the EPA can consider submissions from targeted

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entities and may even extinguish a testing obligation. Looking 

at the text’s plain meaning and the Congress’ intent, we find 

that the “proceeding” continues after the EPA issues a Section

2603(a)(2) test order.

Before 2016, the EPA could compel testing only via a 

rulemaking but a party could nonetheless move to supplement

under Section 2618(b), so long as the party could show 

materiality and reasonable grounds for failing to submit during 

the proceeding. 15 U.S.C. § 2618(b) (1976). “[P]roceeding” 

referred to the rulemaking proceeding because at that time that 

was the only procedural mechanism to compel testing. The 

2016 Amendments amended Section 2618(b), extending its 

application to “an action under this section to review . . . an 

order under section 2603.” 15 U.S.C. § 2618(b) (emphases 

added).

In general, “Proceeding” means “business conducted by a 

court or other official body.” Proceeding, Black’s Law 

Dictionary (11th ed. 2019). An “administrative proceeding” 

means a “hearing, inquiry, investigation, or trial before an 

administrative agency.” Administrative Proceeding, Black’s 

Law Dictionary (11th ed. 2019). The March 2022 Test Order 

does not mark the end of an inquiry, but the beginning. The 

EPA’s investigation of 1,1,2-TCA’s toxicity requires targeted

entities to develop information to aid the EPA in its 

investigation. The March 2022 Test Order is only part of the 

EPA’s ongoing inquiry. The test order’s text supports the 

ongoing nature of the inquiry because, at least under Option 2, 

the EPA considers “whether the study and/or other relevant 

information [submitted by targeted entities] satisfies” the test 

order and may “extinguish those testing obligations from this 

Order that are no longer necessary.” March 2022 Test Order at 

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11.13 A submission under Option 2 can potentially end the 

EPA’s investigation of a specific chemical. Thus, the 

“proceeding” continues after the EPA issues the test order. 

The Congress’ intent also supports our reading of 

“proceeding.” The 2016 Amendments gave the EPA the 

authority to issue test orders without notice to, or past

engagement with, a targeted entity. See S. REP. NO. 114-67, at 

10; H.R. REP. NO. 114-176, at 22–23. The targeted entity

necessarily, then, has no opportunity to submit information to 

the EPA before the test order issues because it has no notice of 

the test order. Vinyl Institute’s interpretation of “proceeding” 

would violate the canon against surplusage because every

Section 2618(b) movant following the test order issuance 

would have “reasonable grounds” for failing to supplement. 

See TRW Inc. v. Andrews, 534 U.S. 19, 31 (2001). 

B. Reasonable Grounds for Delayed Submission

Vinyl Institute claims it had a reasonable ground for failing 

to submit additional information pursuant to Option 2 because 

it did not know what information the EPA had already 

considered and the EPA improperly shifted the burden to prove 

the test order’s necessity to it. We conclude that Option 2 gave 

Vinyl Institute a fair opportunity to submit the Stantec Report. 

Vinyl Institute’s failure to avail itself of Option 2 does not 

constitute reasonable grounds for its delayed submission. It 

need not know exactly what information the EPA considered 

13 Under Option 2, the EPA has extinguished several test orders 

after receiving sufficient studies. With regard to Phosphoric acid 

Triphenyl Ester (TPP), the EPA reviewed a study submitted by the 

target entity and “extinguish[ed] this testing requirement for the 

TSCA Section 4(a)(2) order for TPP.” Memo Extinguishing OCSPP 

850.4500 Testing Requirement, EPA-HQ-OPPT-2018-0458-0054 

(Apr. 30, 2021), https://perma.cc/F7P5-F7SU. 

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to avail itself of Option 2, which instructs it to “[u]se this option 

to submit an existing study and/or other scientifically relevant 

information that you believe the EPA has not considered.” 

March 2022 Test Order at 3 (emphasis added). Option 2 

encourages the targeted entity to submit responsive 

information because it “may be in possession of studies 

unknown or inaccessible to the Agency.” Test Orders Under 

TSCA Section 4: Questions and Answers, EPA Doc. # EPA 

705-G-2021-3737, at 3 (Jan. 2022), https://perma.cc/B8QQWJTB. Vinyl Institute need not submit only information that 

the EPA has not yet considered. The March 2022 Test Order 

itself provides significant information to which Vinyl Institute 

can respond under Option 2. Vinyl Institute had access to the 

119-page final scope document on 1,1,2-TCA risk evaluation, 

the EPA explanation of the “information reasonably available 

to the Administrator” and the agency’s evaluation of the 1979 

Elovaara study. See 15 U.S.C. § 2603(a)(3). Vinyl Institute 

could have submitted a responsive report based on the 

information it believed the EPA had not considered.14 March 

2022 Test Order at 3. Although Option 2 provides only 30 days 

to respond, the March 2022 Test Order explicitly allows for a

deadline extension if requested. Id. at 9–10. Vinyl Institute did 

not request an extension.

In addition, Option 2 does not improperly shift burdens. 

Although Section 2603(a) details duties the EPA must perform 

before issuing a test order, the TSCA ultimately assigns “those 

14 As discussed supra, the complete test order administrative 

record is not available to targeted entities—at least until they institute 

litigation. Vinyl Institute claims it must review the administrative 

record before responding under Option 2. This raises another 

surplusage issue because, according to Vinyl Institute, a targeted

entity without access to the non-public administrative record will 

always have reasonable grounds for failing to respond under Option 

2. 

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who manufacture and those who process such chemical 

substances” the burden to develop information regarding “the 

effect of chemical substances and mixtures on health and the 

environment.” 15 U.S.C. § 2601(b)(1); see CMA, 859 F.2d at 

980. After the EPA satisfies its Section 2603(a)(2) duties and 

issues the order, the burden then shifts to the target entity to 

follow one of the test order options. Option 1 places the burden 

of testing on Vinyl Institute and Option 2 places the burden of 

submitting studies and other scientifically relevant information 

on Vinyl Institute. March 2022 Test Order at 11. The EPA can

extinguish any further testing obligation if it receives sufficient 

information under Option 2.15 Vinyl Institute could have 

submitted the Stantec Report under Option 2. Its failure to do 

so dooms its motion to supplement. 

For the foregoing reasons, we grant Vinyl Institute’s 

petition for review, vacate the March 2022 Test Order and 

remand to the EPA for proceedings consistent with this 

opinion. We deny Vinyl Institute’s motion to supplement.

So ordered.

15 See supra note 13.

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