40520 Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 

Accession Number: 20220630–5132. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2248–000. 

Applicants: Cedar Creek Wind 

Energy, LLC. 

Description: Market: Updated Market 

Power Analysis for the NW Region and 

Revised MBR Tariff to be effective 7/1/ 

2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5137. 

Comment Date: 5 p.m. ET 8/29/22. 

Docket Numbers: ER22–2249–000. 

Applicants: Mountain Breeze Wind, 

LLC. 

Description: Market: Updated Market 

Power Analysis for the NW Region and 

Revised MBR Tariff to be effective 7/1/ 

2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5142. 

Comment Date: 5 p.m. ET 8/29/22. 

Docket Numbers: ER22–2250–000. 

Applicants: Panorama Wind, LLC. 

Description: Market: Updated Market 

Power Analysis for the NW Region and 

Revised MBR Tariff to be effective 7/1/ 

2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5146. 

Comment Date: 5 p.m. ET 8/29/22. 

Docket Numbers: ER22–2251–000. 

Applicants: Tidal Energy Marketing 

(U.S.) L.L.C. 

Description: § 205(d) Rate Filing: MBR 

Tariff Revisions to be effective 7/1/2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5155. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2252–000. 

Applicants: Southwest Power Pool, 

Inc. 

Description: § 205(d) Rate Filing: 

1895R11 Evergy Kansas Central, Inc. 

NITSA NOA to be effective 9/1/2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5158. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2253–000. 

Applicants: PJM Interconnection, 

L.L.C. 

Description: § 205(d) Rate Filing: 

Amendment to WMPA, Service 

Agreement No. 6084; Queue No. AF2– 

292 to be effective 5/4/2021. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5169. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2254–000. 

Applicants: Consolidated Edison 

Company of New York, Inc. 

Description: § 205(d) Rate Filing: 

Electric and Gas Bill Relief Program 

6–30–2022 to be effective 7/1/2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5170. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2255–000. 

Applicants: Duke Energy Progress, 

LLC. 

Description: § 205(d) Rate Filing: DEPRecovery of a Regulatory Asset Related 

to Early Retirement of Roxboro to be 

effective 7/1/2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5181. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2256–000. 

Applicants: New Creek Wind LLC. 

Description: § 205(d) Rate Filing: 

Market-Based Tariff Revisions to be 

effective 7/1/2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5187. 

Comment Date: 5 p.m. ET 7/21/22. 

Docket Numbers: ER22–2257–000. 

Applicants: PJM Interconnection, 

L.L.C. 

Description: § 205(d) Rate Filing: 

Original ISA/CSA, Service Agreement 

Nos. 6527/6515; Queue No. AC1–053 to 

be effective 6/7/2022. 

Filed Date: 6/30/22. 

Accession Number: 20220630–5210. 

Comment Date: 5 p.m. ET 7/21/22. 

The filings are accessible in the 

Commission’s eLibrary system (https://

elibrary.ferc.gov/idmws/search/ 

fercgensearch.asp) by querying the 

docket number. 

Any person desiring to intervene or 

protest in any of the above proceedings 

must file in accordance with Rules 211 

and 214 of the Commission’s 

Regulations (18 CFR 385.211 and 

385.214) on or before 5:00 p.m. Eastern 

time on the specified comment date. 

Protests may be considered, but 

intervention is necessary to become a 

party to the proceeding. 

eFiling is encouraged. More detailed 

information relating to filing 

requirements, interventions, protests, 

service, and qualifying facilities filings 

can be found at: http://www.ferc.gov/ 

docs-filing/efiling/filing-req.pdf. For 

other information, call (866) 208–3676 

(toll free). For TTY, call (202) 502–8659. 

Dated: June 30, 2022. 

Debbie-Anne A. Reese, 

Deputy Secretary. 

[FR Doc. 2022–14455 Filed 7–6–22; 8:45 am] 

BILLING CODE 6717–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2016–0737; FRL–9945–01– 

OCSPP] 

Trichloroethylene (TCE); Draft 

Revision to Toxic Substances Control 

Act (TSCA) Risk Determination; Notice 

of Availability and Request for 

Comment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Environmental Protection 

Agency (EPA) is announcing the 

availability of and seeking public 

comment on a draft revision to the risk 

determination for the trichloroethylene 

(TCE) risk evaluation issued under 

TSCA. The draft revision to the TCE risk 

determination reflects the announced 

policy changes to ensure the public is 

protected from unreasonable risks from 

chemicals in a way that is supported by 

science and the law. In this draft 

revision to the risk determination EPA 

finds that TCE, as a whole chemical 

substance, presents an unreasonable risk 

of injury to health when evaluated 

under its conditions of use. In addition, 

this revised risk determination does not 

reflect an assumption that all workers 

always appropriately wear personal 

protective equipment (PPE). EPA 

understands that there could be 

occupational safety protections in place 

at workplace locations; however, not 

assuming use of PPE reflects EPA’s 

recognition that unreasonable risk may 

exist for subpopulations of workers that 

may be highly exposed because they are 

not covered by OSHA standards, or their 

employers are out of compliance with 

OSHA standards, or because many of 

OSHA’s chemical-specific permissible 

exposure limits largely adopted in the 

1970’s are described by OSHA as being 

‘‘outdated and inadequate for ensuring 

protection of worker health.’’ This 

revision, when final, would supersede 

the condition of use-specific no 

unreasonable risk determinations in the 

November 2020 TCE risk evaluation 

(and withdraw the associated order) and 

would make a revised determination of 

unreasonable risk for TCE as a whole 

chemical substance. 

DATES: Comments must be received on 

or before August 8, 2022. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA—EPA–HQ–OPPT–2016– 

0737, through the Federal eRulemaking 

Portal at https://www.regulations.gov. 

Follow the online instructions for 

submitting comments. Do not submit 


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Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 40521 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Additional instructions on commenting 

and visiting the docket, along with more 

information about dockets generally, is 

available at https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Katelan 

McNamara, Office of Pollution 

Prevention and Toxics (7404M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

564–4361; email address: 

McNamara.Katelan@EPA.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

This action is directed to the public 

in general. This action may, however, be 

of interest to those involved in the 

manufacture, processing, distribution, 

use, disposal, and/or the assessment of 

risks involving chemical substances and 

mixtures. You may be potentially 

affected by this action if you 

manufacture (defined under TSCA to 

include import), process (including 

recycling), distribute in commerce, use 

or dispose of TCE, including TCE in 

products. Since other entities may also 

be interested in this draft revision to the 

risk determination, EPA has not 

attempted to describe all the specific 

entities that may be affected by this 

action. 

B. What is EPA’s authority for taking 

this action? 

TSCA section 6, 15 U.S.C. 2605, 

requires EPA to conduct risk 

evaluations to determine whether a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, without consideration 

of costs or other non-risk factors, 

including an unreasonable risk to a 

potentially exposed or susceptible 

subpopulation (PESS) identified as 

relevant to the risk evaluation by the 

Administrator, under the conditions of 

use. 15 U.S.C. 2605(b)(4)(A). TSCA 

sections 6(b)(4)(A) through (H) 

enumerate the deadlines and minimum 

requirements applicable to this process, 

including provisions that provide 

instruction on chemical substances that 

must undergo evaluation, the minimum 

components of a TSCA risk evaluation, 

and the timelines for public comment 

and completion of the risk evaluation. 

TSCA also requires that EPA operate in 

a manner that is consistent with the best 

available science, make decisions based 

on the weight of the scientific evidence, 

and consider reasonably available 

information. 15 U.S.C. 2625(h), (i), and 

(k). 

The statute identifies the minimum 

components for all chemical substance 

risk evaluations. For each risk 

evaluation, EPA must publish a 

document that outlines the scope of the 

risk evaluation to be conducted, which 

includes the hazards, exposures, 

conditions of use, and the potentially 

exposed or susceptible subpopulations 

that EPA expects to consider. 15 U.S.C. 

2605(b)(4)(D). The statute further 

provides that each risk evaluation must 

also: (1) integrate and assess available 

information on hazards and exposures 

for the conditions of use of the chemical 

substance, including information that is 

relevant to specific risks of injury to 

health or the environment and 

information on relevant potentially 

exposed or susceptible subpopulations; 

(2) describe whether aggregate or 

sentinel exposures were considered and 

the basis for that consideration; (3) take 

into account, where relevant, the likely 

duration, intensity, frequency, and 

number of exposures under the 

conditions of use; and (4) describe the 

weight of the scientific evidence for the 

identified hazards and exposures. 15 

U.S.C. 2605(b)(4)(F)(i) through (ii) and 

(iv) through (v). Each risk evaluation 

must not consider costs or other nonrisk factors. 15 U.S.C. 2605(b)(4)(F)(iii). 

EPA has inherent authority to 

reconsider previous decisions and to 

revise, replace, or repeal a decision to 

the extent permitted by law and 

supported by reasoned explanation. FCC 

v. Fox Television Stations, Inc., 556 U.S. 

502, 515 (2009); see also Motor Vehicle 

Mfrs. Ass’n v. State Farm Mutual Auto. 

Ins. Co., 463 U.S. 29, 42 (1983). 

Pursuant to such authority, EPA is 

reconsidering the risk determinations in 

the November 2020 TCE Risk 

Evaluation. 

C. What action is EPA taking? 

EPA is announcing the availability of 

and seeking public comment on a draft 

revision to the risk determination for the 

risk evaluation for TCE under TSCA, 

which was initially published in 

November 2020 (Ref. 1). EPA is 

specifically seeking public comment on 

the draft revision to the risk 

determination for the risk evaluation 

where the agency intends to determine 

that TCE, as a whole chemical, presents 

an unreasonable risk of injury to health 

when evaluated under its conditions of 

use. The Agency’s risk determination for 

TCE is better characterized as a whole 

chemical risk determination rather than 

condition-of-use-specific risk 

determinations. Accordingly, EPA 

would revise and replace section 5 of 

the risk evaluation for TCE where the 

findings of unreasonable risk to health 

were previously made for the individual 

conditions of use evaluated. EPA would 

also withdraw the order issued 

previously for 2 conditions of use 

previously determined not to present 

unreasonable risk. 

This revision would be consistent 

with EPA’s plans to revise specific 

aspects of the first ten TSCA chemical 

risk evaluations in order to ensure that 

the risk evaluations better align with 

TSCA’s objective of protecting health 

and the environment. Under the draft 

revision, the same 52 conditions of use 

would continue to drive the 

unreasonable risk determination for 

TCE. Removing the assumptions that 

workers always and appropriately wear 

PPE (see Unit II.C.) when making the 

whole chemical risk determination for 

TCE would not alter the conditions of 

use that drive the unreasonable risk 

determination for TCE, though 

additional risks for acute non-cancer 

and cancer effects from inhalation and 

dermal exposures would also drive the 

unreasonable risk in many of those 

conditions of use (where previously 

those conditions of use were identified 

as presenting unreasonable risk for 

chronic non-cancer effects and cancer). 

Overall, 52 conditions of use out of 54 

EPA evaluated would drive the TCE 

whole chemical unreasonable risk 

determination due to risks identified for 

human health. The full list of the 

conditions of use evaluated for the TCE 

TSCA risk evaluation is in Tables 4–59 

and 4–60 of the risk evaluation (Ref. 2). 

D. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 


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40522 Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/ 

comments.html. 

II. Background 

A. Why is EPA re-issuing the risk 

determination for the TCE risk 

evaluation conducted under TSCA? 

In 2016, as directed by TSCA section 

6(b)(2)(A), EPA chose the first ten 

chemical substances to undergo risk 

evaluations under the amended TSCA. 

These chemical substances are asbestos, 

1-bromopropane, carbon tetrachloride, 

C.I. Pigment Violet (PV 29), cyclic 

aliphatic bromide cluster (HBCD), 1,4- 

dioxane, methylene chloride, nmethylpyrrolidone (NMP), 

perchloroethylene (PCE), and 

trichloroethylene (TCE). 

From June 2020 to January 2021, EPA 

published risk evaluations on the first 

ten chemical substances, including for 

TCE in November 2020. The risk 

evaluations included individual 

unreasonable risk determinations for 

each condition of use evaluated. EPA 

issued determinations that particular 

conditions of use did not present an 

unreasonable risk by order under TSCA 

section 6(i)(1). 

In accordance with Executive Order 

13990 (Ref. 3) and other Administration 

priorities (Refs. 4, 5, and 6), EPA 

reviewed the risk evaluations for the 

first ten chemical substances, including 

TCE, to ensure that they meet the 

requirements of TSCA, including 

conducting decision making in a 

manner that is consistent with the best 

available science. 

As a result of this review, EPA 

announced plans to revise specific 

aspects of the first ten risk evaluations 

in order to ensure that the risk 

evaluations appropriately identify 

unreasonable risks and thereby help 

ensure the protection of human health 

and the environment (Ref. 7). To that 

end, EPA is reconsidering two key 

aspects of the risk determinations for 

TCE published in November 2020. First, 

following a review of specific aspects of 

the November 2020 TCE risk evaluation, 

EPA proposes that making an 

unreasonable risk determination for TCE 

as a whole chemical substance, rather 

than making unreasonable risk 

determinations separately on each 

individual condition of use evaluated in 

the risk evaluation, is the most 

appropriate approach to TCE under the 

statute and implementing regulations. 

Second, EPA proposes that the risk 

determination should be explicit that it 

does not rely on assumptions regarding 

the use of personal protective 

equipment (PPE) in making the 

unreasonable risk determination under 

TSCA section 6, even though some 

facilities might be using PPE as one 

means to reduce workers exposures; 

rather, the use of PPE would be 

considered during risk management as 

appropriate. 

Separately, EPA is conducting a 

screening approach to assess potential 

risks from the air and water pathways 

for several of the first 10 chemicals, 

including this chemical. For TCE the 

exposure pathways that were or could 

be regulated under another EPA 

administered statute were excluded 

from the final risk evaluation (see 

section 1.4.2 of the November 2020 TCE 

risk evaluation). This resulted in the 

ambient air and ambient water 

pathways for TCE not being assessed. 

The goal of the recently-developed 

screening approach is to remedy this 

exclusion and to identify if there are 

risks that were unaccounted for in the 

TCE risk evaluation. While this analysis 

is underway, EPA is not incorporating 

the screening-level approach into this 

draft revised unreasonable risk 

determination. If the results suggest 

there is additional risk, EPA will 

determine if the risk management 

approaches being contemplated for TCE 

will protect against these risks or if the 

risk evaluation will need to be formally 

supplemented or revised. 

This action pertains only to the risk 

determination for TCE. While EPA 

intends to consider and may take 

additional similar actions on other of 

the first ten chemicals, EPA is taking a 

chemical-specific approach to reviewing 

the risk evaluations and is incorporating 

new policy direction in a surgical 

manner, while being mindful of the 

Congressional direction on the need to 

complete risk evaluations and move 

toward any associated risk management 

activities in accordance with statutory 

deadlines. 

B. What is a whole chemical view of the 

unreasonable risk determination for the 

TCE risk evaluation? 

TSCA section 6 repeatedly refers to 

determining whether a chemical 

substance presents unreasonable risk 

under its conditions of use. 

Stakeholders have disagreed over 

whether a chemical substance should 

receive: A single determination that is 

comprehensive for the chemical 

substance after considering the 

conditions of use, referred to as a wholechemical determination; or multiple 

determinations, each of which is 

specific to a condition of use, referred 

to as condition-of-use-specific 

determinations. 

The proposed risk evaluation 

procedural rule was premised on the 

whole chemical approach to making an 

unreasonable risk determination (Ref. 

8). In that proposed rule, EPA 

acknowledged a lack of specificity in 

statutory text that might lead to different 

views about whether the statute 

compelled EPA’s risk evaluations to 

address all conditions of use of a 

chemical substance or whether EPA had 

discretion to evaluate some subset of 

conditions of use (i.e., to scope out some 

manufacturing, processing, distribution 

in commerce, use, or disposal 

activities), but also stated that ‘‘EPA 

believes the word ‘the’ (in TSCA section 

6(b)(4)(A)) is best interpreted as calling 

for evaluation that considers all 

conditions of use.’’ (Ref. 8). 

The proposed rule, however, was 

unambiguous on the point that an 

unreasonable risk determination would 

be for the chemical substance as a 

whole, even if based on a subset of uses. 

(See Ref. 8 at pgs. 7565–66: ‘‘TSCA 

section 6(b)(4)(A) specifies that a risk 

evaluation must determine whether ‘a 

chemical substance’ presents an 

unreasonable risk of injury to health or 

the environment ‘under the conditions 

of use.’ The evaluation is on the 

chemical substance—not individual 

conditions of use—and it must be based 

on ‘the conditions of use.’ In this 

context, EPA believes the word ‘the’ is 

best interpreted as calling for evaluation 

that considers all conditions of use.’’). 

In the proposed regulatory text, EPA 

proposed to determine whether the 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment under the conditions of 

use (Ref. 8 at pg. 7480). 

The final risk evaluation procedural 

rule stated (82 FR 33726, July 20, 2017) 

(FRL–9964–38) (Ref. 9): ‘‘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.’’ (See also 40 CFR 

702.47). For the unreasonable risk 

determinations in the first ten risk 

evaluations, EPA applied this provision 

by making individual risk 

determinations for each condition of use 

evaluated in each risk evaluation (i.e., 

the condition-of-use-specific approach 

to risk determinations). That approach 

was based on one particular passage in 

the preamble to the final risk evaluation 


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procedural rule, which stated that EPA 

will make individual risk 

determinations for all conditions of use 

identified in the scope. (Ref. 9 at pg. 

33744). 

In contrast to this portion of the 

preamble of the final risk evaluation 

procedural rule, the regulatory text itself 

and other statements in the preamble 

reference a risk determination for the 

chemical substance under its conditions 

of use, rather than separate risk 

determinations for each of the 

conditions of use of a chemical 

substance. In the key regulatory 

provision excerpted earlier from 40 CFR 

702.47, the text explains that, ‘‘[a]s 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’’ (Ref. 

9, emphasis added). Other language 

reiterates this perspective. For example, 

40 CFR 702.31(a) states that the purpose 

of the rule is to establish the EPA 

process for conducting a risk evaluation 

to determine whether a chemical 

substance presents an unreasonable risk 

of injury to health or the environment 

as required under TSCA section 

6(b)(4)(B). Likewise, there are recurring 

references to whether the chemical 

substance presents an unreasonable risk 

in 40 CFR 702.41(a). See, for example, 

40 CFR 702.41(a)(6), which explains 

that the extent to which EPA will refine 

its evaluations for one or more 

condition of use in any risk evaluation 

will vary as necessary to determine 

whether a chemical substance presents 

an unreasonable risk. Notwithstanding 

the one preambular statement about 

condition-of-use-specific risk 

determinations, the preamble to the 

final rule also contains support for a risk 

determination on the chemical 

substance as a whole. In discussing the 

identification of the conditions of use of 

a chemical substance, the preamble 

notes that this task inevitably involves 

the exercise of discretion on EPA’s part, 

and ‘‘as EPA interprets the statute, the 

Agency is to exercise that 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.’’ (Ref. 8 at pg. 

33729). 

Therefore, notwithstanding EPA’s 

choice to issue condition-of-use-specific 

risk determinations to date, EPA 

interprets its risk evaluation regulation 

to also allow the Agency to issue wholechemical risk determinations. Either 

approach is permissible under the 

regulation. A panel of the Ninth Circuit 

Court of Appeals also recognized the 

ambiguity of the regulation on this 

point. Safer Chemicals v. EPA, 943 F.3d 

397, 413 (9th Cir. 2019) (holding a 

challenge about ‘‘use-by-use risk 

evaluations [was] 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’’). 

EPA plans to consider the appropriate 

approach for each chemical substance 

risk evaluation on a case-by-case basis, 

taking into account considerations 

relevant to the specific chemical 

substance in light of the Agency’s 

obligations under TSCA. The Agency 

expects that this case-by-case approach 

will provide greater flexibility in the 

Agency’s ability to evaluate and manage 

unreasonable risk from individual 

chemical substances. EPA believes this 

is a reasonable approach under TSCA 

and the Agency’s implementing 

regulations. 

With regard to the specific 

circumstances of TCE, as further 

explained in this notice, EPA proposes 

that a whole chemical approach is 

appropriate for TCE in order to protect 

health and the environment. The whole 

chemical approach is appropriate for 

TCE because there are benchmark 

exceedances for multiple conditions of 

use (spanning across most aspects of the 

chemical lifecycle—from manufacturing 

(including import), processing, 

commercial and industrial use, 

consumer use, and disposal) for health 

of workers, occupational non-users, 

consumers, and bystanders associated 

with TCE exposures. Because these 

chemical-specific properties cut across 

the conditions of use within the scope 

of the risk evaluation, a substantial 

amount of the conditions of use drive 

the unreasonable risk; therefore, it is 

appropriate for the Agency to make a 

determination for TCE that the whole 

chemical presents an unreasonable risk. 

As explained later in this document, 

the revisions to the unreasonable risk 

determination (section 5 of the risk 

evaluation) would be based on the 

existing risk characterization section of 

the risk evaluation (section 4 of the risk 

evaluation) and would not involve 

additional technical or scientific 

analysis. The discussion of the issues 

presented in this Federal Register 

notice and in the accompanying draft 

revision to the risk determination would 

supersede any conflicting statements in 

the prior TCE risk evaluation and the 

response to comments document (Ref. 

10). With respect to the TCE risk 

evaluation, EPA intends to change the 

risk determination to a whole chemical 

approach without considering the use of 

PPE and does not intend to amend, nor 

does a whole chemical approach require 

amending, the underlying scientific 

analysis of the risk evaluation in the risk 

characterization section of the risk 

evaluation. EPA views the peer 

reviewed hazard and exposure 

assessments and associated risk 

characterization as robust and 

upholding the standards of best 

available science and weight of the 

scientific evidence per TSCA sections 

26(h) and (i). 

EPA is announcing the availability of 

and seeking public comment on the 

draft superseding unreasonable risk 

determination for TCE, including a 

description of the risks driving the 

unreasonable risk determination under 

the conditions of use for the chemical 

substance as a whole. For purposes of 

TSCA section 6(i), EPA is making a draft 

risk determination on TCE as a whole 

chemical. Under the proposed revised 

approach, the ‘‘whole chemical’’ risk 

determination for TCE would supersede 

the no unreasonable risk determinations 

for TCE that were premised on a 

condition-of-use-specific approach to 

determining unreasonable risk. When 

finalized, EPA’s revised unreasonable 

risk determination would also contain 

an order withdrawing the TSCA section 

6(i)(1) order in section 5.4.1 of the 

November 2020 TCE risk evaluation. 

C. What revision does EPA propose 

about the use of PPE for the TCE risk 

evaluation? 

In the risk evaluations for the first ten 

chemical substances, as part of the 

unreasonable risk determination, EPA 

assumed for several conditions of use 

that all workers were provided and 

always used PPE in a manner that 

achieves the stated assigned protection 

factor (APF) for respiratory protection, 

or used impervious gloves for dermal 

protection. In support of this 

assumption, EPA considered reasonably 

available information such as public 

comments indicating that some 

employers, particularly in the industrial 

setting, provide PPE to their employees 

and follow established worker 

protection standards (e.g., Occupational 

Safety and Health Administration 

(OSHA) requirements for protection of 

workers). 

For the November 2020 TCE risk 

evaluation, EPA assumed that workers 

used PPE for 21 occupational conditions 

of use. However, in the November 2020 

TCE risk evaluation, EPA determined 

that there is unreasonable risk to 


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workers for all these COUs even with 

this assumed PPE use. 

EPA is revising the assumption for 

TCE that workers always or properly use 

PPE, although it does not question the 

public comments received regarding the 

occupational safety practices often 

followed by industry respondents. 

When characterizing the risk to human 

health from occupational exposures 

during risk evaluation under TSCA, 

EPA believes it is appropriate to 

evaluate the levels of risk present in 

baseline scenarios where PPE is not 

assumed to be used by workers. This 

approach of not assuming PPE use by 

workers considers the risk to potentially 

exposed or susceptible subpopulations 

(workers and occupational non-users) 

who may not be covered by OSHA 

standards, such as self-employed 

individuals and public sector workers 

who are not covered by a State Plan. It 

should be noted that, in some cases, 

baseline conditions may reflect certain 

mitigation measures, such as 

engineering controls, in instances where 

exposure estimates are based on 

monitoring data at facilities that have 

engineering controls in place. 

In addition, EPA believes it is 

appropriate to evaluate the levels of risk 

present in scenarios considering 

applicable OSHA requirements (e.g., 

chemical-specific permissible exposure 

limits (PELs) and/or chemical-specific 

PELs with additional substance-specific 

standards) as well as scenarios 

considering industry or sector best 

practices for industrial hygiene that are 

clearly articulated to the Agency. It 

should be noted that, in some cases, 

baseline conditions may reflect certain 

mitigation measures, such as 

engineering controls, in instances where 

exposure estimates are based on 

monitoring data at facilities that have 

engineering controls in place. 

Consistent with this approach, the 

November 2020 TCE risk evaluation 

characterized risk to workers both with 

and without the use of PPE. By 

characterizing risks using scenarios that 

reflect different levels of mitigation, 

EPA risk evaluations can help inform 

potential risk management actions by 

providing information that could be 

used during risk management to tailor 

risk mitigation appropriately to address 

any unreasonable risk identified, or to 

ensure that applicable OSHA 

requirements or industry or sector best 

practices that address the unreasonable 

risk are required for all potentially 

exposed or susceptible subpopulations 

(including self-employed individuals 

and public sector workers who are not 

covered by an OSHA State Plan). 

When undertaking unreasonable risk 

determinations as part of TSCA risk 

evaluations, however, EPA does not 

believe it is appropriate to assume as a 

general matter that an applicable OSHA 

requirement or industry practices 

related to PPE use is consistently and 

always properly applied. Mitigation 

scenarios included in the EPA risk 

evaluation (e.g., scenarios considering 

use of various PPE) likely represent 

what is happening already in some 

facilities. However, the Agency cannot 

assume that all facilities have adopted 

these practices for the purposes of 

making the TSCA risk determination. 

Therefore, EPA proposes to make a 

determination of unreasonable risk for 

TCE from a baseline scenario that does 

not assume compliance with OSHA 

standards, including any applicable 

exposure limits or requirements for use 

of respiratory protection or other PPE. 

Making unreasonable risk 

determinations based on the baseline 

scenario should not be viewed as an 

indication that EPA believes there are 

no occupational safety protections in 

place at any location, or that there is 

widespread non-compliance with 

applicable OSHA standards. Rather, it 

reflects EPA’s recognition that 

unreasonable risk may exist for 

subpopulations of workers that may be 

highly exposed because they are not 

covered by OSHA standards, such as 

self-employed individuals and public 

sector workers who are not covered by 

a State Plan, or because their employer 

is out of compliance with OSHA 

standards, or because many of OSHA’s 

chemical-specific permissible exposure 

limits largely adopted in the 1970’s are 

described by OSHA as being ‘‘outdated 

and inadequate for ensuring protection 

of worker health’’ (Ref. 11), or because 

EPA finds unreasonable risk for 

purposes of TSCA notwithstanding 

OSHA requirements. 

In accordance with this approach, 

EPA is proposing the draft revision to 

the TCE risk determination without 

relying on assumptions regarding the 

occupational use of PPE in making the 

unreasonable risk determination under 

TSCA section 6; rather, information on 

the use of PPE as a means of mitigating 

risk (including information received 

from industry respondents about 

occupational safety practices in use) 

would be considered during the risk 

management phase as appropriate. This 

would represent a change from the 

approach taken in the 2020 risk 

evaluation for TCE and EPA invites 

comments on this draft change to the 

TCE risk determination. As a general 

matter, when undertaking risk 

management actions, EPA intends to 

strive for consistency with applicable 

OSHA requirements and industry best 

practices, including appropriate 

application of the hierarchy of controls, 

when those measures would address an 

identified unreasonable risk, including 

unreasonable risk to potentially exposed 

or susceptible subpopulations. 

Consistent with TSCA section 9(d), EPA 

will consult and coordinate TSCA 

activities with OSHA and other relevant 

Federal agencies for the purpose of 

achieving the maximum applicability of 

TSCA while avoiding the imposition of 

duplicative requirements. Informed by 

the mitigation scenarios and 

information gathered during the risk 

evaluation and risk management 

process, the Agency might propose rules 

that require risk management practices 

that may be already common practice in 

many or most facilities. Adopting clear, 

comprehensive regulatory standards 

will foster compliance across all 

facilities (ensuring a level playing field) 

and assure protections for all affected 

workers, especially in cases where 

current OSHA standards may not apply 

or be sufficient to address the 

unreasonable risk. 

Removing the assumption that all 

workers always and appropriately wear 

PPE in making the whole chemical risk 

determination for TCE would not result 

in additional conditions of use to the 

original 52 conditions of use that drive 

the unreasonable risk, though EPA 

would identify additional risks for acute 

non-cancer and cancer effects from 

inhalation and dermal exposures as 

driving the unreasonable risk within 

many of those conditions of use (where 

previously those conditions of use were 

identified as presenting unreasonable 

risk only for chronic non-cancer effects 

and cancer due to assumed use of PPE). 

The draft revision to the risk 

determination would clarify that EPA 

does not rely on the assumed use of PPE 

when making the risk determination for 

the whole substance. EPA is requesting 

comment on this potential change. 

D. What is TCE? 

TCE is a colorless liquid with a 

pleasant, sweet odor resembling that of 

chloroform. It is considered a volatile 

organic compound and has a wide range 

of uses in consumer and commercial 

products and in industry. An estimated 

84% of TCE’s annual production 

volume is used as an intermediate in the 

manufacture of the hydrofluorocarbon, 

HFC–134a, an alternative to the 

refrigerant chlorofluorocarbon, CFC–12. 

Another 15% of TCE production volume 

is used as a degreasing solvent, leaving 

approximately 2% for other uses. The 

total aggregate production volume 


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decreased from 220.5 to 171.9 million 

pounds between 2012 and 2015. 

E. What conclusions did EPA reach 

about the risks of TCE in the 2020 TSCA 

risk evaluation and what conclusions is 

EPA proposing to reach based on the 

whole chemical approach and not 

assuming the use of PPE? 

In the 2020 risk evaluation, EPA 

determined that TCE presents an 

unreasonable risk to health under the 

following conditions of use: 

• Manufacturing: domestic 

manufacture; 

• Manufacturing: import; 

• Processing: processing as a reactant/ 

intermediate; 

• Processing: incorporation into a 

formulation, mixture or reaction 

product; 

• Processing: incorporation into 

articles; 

• Processing: repackaging; 

• Processing: recycling; 

• Industrial and commercial use as a 

solvent for open-top batch vapor 

degreasing; 

• Industrial and commercial use as a 

solvent for closed-loop batch vapor 

degreasing; 

• Industrial and commercial use as a 

solvent for in-line conveyorized vapor 

degreasing; 

• Industrial and commercial use as a 

solvent for in-line web cleaner vapor 

degreasing; 

• Industrial and commercial use as a 

solvent for cold cleaning; 

• Industrial and commercial use as a 

solvent for aerosol spray degreaser/ 

cleaner and mold release; 

• Industrial and commercial use as a 

lubricant and grease in tap and die 

fluid; 

• Industrial and commercial use as a 

lubricant and grease in penetrating 

lubricant; 

• Industrial and commercial use as an 

adhesive and sealant in solvent-based 

adhesives and sealants; tire repair 

cement/sealer; mirror edge sealant; 

• Industrial and commercial use as a 

functional fluid in heat exchange fluid; 

• Industrial and commercial use in 

paints and coatings as a diluent in 

solvent-based paints and coatings; 

• Industrial and commercial use in 

cleaning and furniture care products in 

carpet cleaner and wipe cleaning; 

• Industrial and commercial use in 

laundry and dishwashing products in 

spot remover; 

• Industrial and commercial use in 

arts, crafts, and hobby materials in 

fixatives and finishing spray coatings; 

• Industrial and commercial use in 

corrosion inhibitors and anti-scaling 

agents; 

• Industrial and commercial use in 

processing aids in process solvent used 

in battery manufacture; process solvent 

used in polymer fabric spinning, 

fluoroelastomer manufacture and 

Alcantara manufacture; extraction 

solvent used in caprolactam 

manufacture; precipitant used in betacyclodextrin manufacture; 

• Industrial and commercial use as 

ink, toner and colorant products in 

toner aid; 

• Industrial and commercial use in 

automotive care products in brake parts 

cleaner; 

• Industrial and commercial use in 

apparel and footwear care products in 

shoe polish; 

• Industrial and commercial use in 

hoof polish; gun scrubber; pepper spray; 

other miscellaneous industrial and 

commercial uses; 

• Consumer use as a solvent in brake 

and parts cleaner; 

• Consumer use as a solvent in 

aerosol electronic degreaser/cleaner; 

• Consumer use as a solvent in liquid 

electronic degreaser/cleaner; 

• Consumer use as a solvent in 

aerosol spray degreaser/cleaner; 

• Consumer use as a solvent in liquid 

degreaser/cleaner; 

• Consumer use as a solvent in 

aerosol gun scrubber; 

• Consumer use as a solvent in liquid 

gun scrubber; 

• Consumer use as a solvent in mold 

release; 

• Consumer use as a solvent in 

aerosol tire cleaner; 

• Consumer use as a solvent in liquid 

tire cleaner; 

• Consumer use as a lubricant and 

grease in tap and die fluid; 

• Consumer use as a lubricant and 

grease in penetrating lubricant; 

• Consumer use as an adhesive and 

sealant in solvent-based adhesives and 

sealants; 

• Consumer use as an adhesive and 

sealant in mirror edge sealant; 

• Consumer use as an adhesive and 

sealant in tire repair cement/sealer; 

• Consumer use as a cleaning and 

furniture care product in carpet cleaner; 

• Consumer use as a cleaning and 

furniture care product in aerosol spot 

remover; 

• Consumer use as a cleaning and 

furniture case product in liquid spot 

remover; 

• Consumer use in arts, crafts, and 

hobby materials in fixative and finishing 

spray coatings; 

• Consumer use in apparel and 

footwear products in shoe polish; 

• Consumer use in fabric spray; 

• Consumer use in film cleaner; 

• Consumer use in hoof polish; 

• Consumer use in toner aid; and 

• Disposal. 

Under the proposed whole chemical 

approach to the TCE risk determination, 

the unreasonable risk from TCE would 

continue to be driven by risk from those 

same conditions of use. In addition, by 

removing the assumption of PPE use in 

making the whole chemical risk 

determination for TCE, there are no 

additional conditions of use that would 

drive the draft unreasonable risk 

determination. The same 52 COUs out 

of the 54 EPA evaluated would continue 

to drive EPA’s unreasonable risk 

determination, though additional risks 

for acute non-cancer and cancer effects 

from inhalation and dermal exposures 

would drive the unreasonable risk 

within many of those conditions of use 

(where previously those conditions of 

use were identified as presenting 

unreasonable risk only for chronic noncancer effects and cancer due to 

assumed use of PPE). Overall, 52 

conditions of use out of the 54 EPA 

evaluated would drive the TCE whole 

chemical unreasonable risk 

determination. 

III. Revision of the November 2020 Risk 

Evaluation 

A. Why is EPA proposing to revise the 

risk determination for the TCE risk 

evaluation? 

EPA is proposing to revise the risk 

determination for the TCE risk 

evaluation pursuant to TSCA section 

6(b) and consistent with Executive 

Order 13990, (‘‘Protecting Public Health 

and the Environment and Restoring 

Science to Tackle the Climate Crisis’’) 

and other Administration priorities 

(Refs. 3, 4, and 6). EPA is revising 

specific aspects of the first ten TSCA 

existing chemical risk evaluations in 

order to ensure that the risk evaluations 

better align with TSCA’s objective of 

protecting health and the environment. 

For the TCE risk evaluation, this 

includes the draft revision: (1) making 

the risk determination in this instance 

based on the whole chemical substance 

instead of by individual conditions of 

use, and (2) emphasizing that EPA does 

not rely on the assumed use of PPE 

when making the risk determination. 

B. What are the draft revisions? 

EPA is releasing a draft revision of the 

risk determination for the TCE risk 

evaluation pursuant to TSCA section 

6(b). Under the revised determination, 

EPA preliminarily concludes that TCE, 

as evaluated in the risk evaluation as a 

whole, presents an unreasonable risk of 

injury to health under its conditions of 

use. This revision would replace the 


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40526 Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 

previous unreasonable risk 

determinations made for TCE by 

individual conditions of use, supersede 

the determinations (and withdraw the 

associated order) of no unreasonable 

risk for the conditions of use identified 

in the TSCA section 6(i)(1) no 

unreasonable risk order, and clarify the 

lack of reliance on assumed use of PPE 

as part of the risk determination. 

These draft revisions do not alter any 

of the underlying technical or scientific 

information that informs the risk 

characterization, and as such the 

hazard, exposure, and risk 

characterization sections are not 

changed except to the extent that 

statements about PPE assumptions in 

sections 2.3.1.2.5 (Dermal Exposure 

Modeling) and section 4.2.2 (Risk 

Estimation for Occupational Exposures), 

Table 4–9 (Inhalation Exposure Data 

Summary and PPE Use Determination), 

of the TCE risk evaluation would be 

superseded. The discussion of the issues 

in this notice and in the accompanying 

draft revision to the risk determination 

would supersede any conflicting 

statements in the prior executive 

summary and sections 2.3.1.2.5 and 

4.2.2 from the TCE risk evaluation and 

the response to comments document 

(Refs. 2 and 10). Additional policy 

changes to other chemical risk 

evaluations, including any 

consideration of potentially exposed or 

susceptible subpopulations and/or 

inclusion of additional exposure 

pathways, are not necessarily reflected 

in these draft revisions to the risk 

determination. 

C. Will the draft revised risk 

determination be peer reviewed? 

The risk determination (section 5 in 

the November 2020 risk evaluation) was 

not part of the scope of the peer reviews 

of the TCE risk evaluation by the 

Science Advisory Committee on 

Chemicals (SACC). Thus, consistent 

with that approach, EPA does not 

intend to conduct peer review of the 

draft revised unreasonable risk 

determination for the TCE risk 

evaluation because no technical or 

scientific changes will be made to the 

hazard or exposure assessments or the 

risk characterization. 

D. What are the next steps for finalizing 

revisions to the risk determination? 

EPA will review and consider public 

comment received on the draft revised 

risk determination for the TCE risk 

evaluation and, after considering those 

public comments, issue the revised final 

TCE risk determination. If finalized as 

drafted, EPA would also issue a new 

order to withdraw the TSCA section 

6(i)(1) no unreasonable risk order issued 

in Section 5.4.1 of the 2020 TCE risk 

evaluation. This final revised risk 

determination would supersede the 

November 2020 risk determinations of 

no unreasonable risk. Consistent with 

the statutory requirements of TSCA 

section 6(a), the Agency would then 

propose risk management actions to 

address the unreasonable risk 

determined in the TCE risk evaluation. 

IV. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not physically located in 

the docket. For assistance in locating 

these other documents, please consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

1. EPA Draft Revised Unreasonable Risk 

Determination for TCE, Section 5, July 

2022. 

2. EPA Risk Evaluation for Trichloroethylene. 

EPA Document #740–R–18–008. 

November 2020. https://www.epa.gov/ 

sites/default/files/2020-11/documents/ 

1._risk_evaluation_for_

trichloroethylene_tce_casrn_79-01-6.pdf. 

3. Executive Order 13990. Protecting Public 

Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis. Federal Register. 86 FR 7037, 

January 25, 2021. 

4. Executive Order 13985. Advancing Racial 

Equity and Support for Underserved 

Communities Through the Federal 

Government. Federal Register. 86 FR 

7009, January 25, 2021. 

5. Executive Order 14008. Tackling the 

Climate Crisis at Home and Abroad. 

Federal Register. 86 FR 7619, February 

1, 2021. 

6. Presidential Memorandum. Memorandum 

on Restoring Trust in Government 

Through Scientific Integrity and 

Evidence-Based Policymaking. Federal 

Register. 86 FR 8845, February 10, 2021. 

7. EPA Press Release. EPA Announces Path 

Forward for TSCA Chemical Risk 

Evaluations. June 2021. https://

www.epa.gov/newsreleases/epaannounces-path-forward-tsca-chemicalrisk-evaluations. 

8. EPA. Proposed Rule; Procedures for 

Chemical Risk Evaluation Under the 

Amended Toxic Substances Control Act. 

Federal Register. 82 FR 7562, January 

19, 2017 (FRL–9957–75). 

9. EPA. Final Rule; Procedures for Chemical 

Risk Evaluation Under the Amended 

Toxic Substances Control Act. Federal 

Register. 82 FR 33726, July 20, 2017 

(FRL–9964–38). 

10. EPA. Summary of External Peer Review 

and Public Comments and Disposition 

for Trichloroethylene (TCE). November 

2020. https://www.regulations.gov/ 

document/EPA-HQ-OPPT-2019-0500- 

0114. 

11. Occupational Safety and Health 

Administration. Permissible Exposure 

Limits—Annotated Tables. Accessed 

June 13, 2022. https://www.osha.gov/ 

annotated-pels. 

Authority: 15 U.S.C. 2601 et seq. 

Dated: July 1, 2022. 

Michal Freedhoff, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

[FR Doc. 2022–14478 Filed 7–6–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OLEM–2018–0105, FRL–10000– 

01–OMS] 

Information Collection Request 

Submitted to OMB for Review and 

Approval; Comment Request; Oil 

Pollution Act Facility Response Plans 

(Renewal) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Environmental Protection 

Agency (EPA) has submitted an 

information collection request (ICR), Oil 

Pollution Act Facility Response Plans 

(EPA ICR Number 1630.14, OMB 

Control Number 2050–0135) to the 

Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act. This is a proposed 

extension of the ICR, which is currently 

approved through July 31, 2022. Public 

comments were previously requested 

via the Federal Register on November 

10, 2021 during a 60-day comment 

period. This notice allows for an 

additional 30 days for public comments. 

A fuller description of the ICR is given 

below, including its estimated burden 

and cost to the public. An agency may 

not conduct or sponsor and a person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

DATES: Additional comments may be 

submitted on or before August 8, 2022. 

ADDRESSES: Submit your comments, 

referencing Docket ID No. EPA–HQ– 

OLEM–2018–0105, to EPA online using 

www.regulations.gov (our preferred 

method) or by mail to: EPA Docket 

Center, Environmental Protection 

Agency, Mail Code 28221T, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460. EPA’s policy is that all 

comments received will be included in 

the public docket without change 


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