Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39511 

1On March 1, 2022, NYPA requested that the 

deadline for filing motions to intervene and 

protests, comments, recommendations, preliminary 

terms and conditions, and preliminary fishway 

prescriptions be extended until June 11, 2022, in 

order to allow parties to work on a settlement 

agreement. On March 3, 2022, Erie requested a 

similar extension. Commission staff granted both 

requests for extension in letters issued on March 10, 

2022. 

2The Council on Environmental Quality’s (CEQ) 

regulations under 40 CFR 1501.10(b)(1) require that 

EAs be completed within 1 year of the federal 

action agency’s decision to prepare an EA. This 

notice establishes the Commission’s intent to 

prepare a draft and final EA for the Hinckley-Jarvis 

and West Canada Creek projects. Therefore, in 

accordance with CEQ’s regulations, the final EA 

must be issued within 1 year of the issuance date 

of this notice. 

Jarvis) Hydroelectric Project (HinckleyJarvis Project; FERC No. 3211). The 

Hinckley-Jarvis Project is located on 

West Canada Creek near the Hamlet of 

Hinckley in the counties of Oneida and 

Herkimer, New York. On February 26, 

2021, Erie Boulevard Hydropower, L.P. 

(Erie) filed an application for a new 

major license for the 39.75-megawatt 

West Canada Creek Hydroelectric 

Project (West Canada Creek Project; 

FERC No. 2701). The West Canada 

Creek Project is also located on West 

Canada Creek, downstream of the 

Hinckley-Jarvis Project, in the counties 

of Oneida and Herkimer, New York. No 

federal or tribal lands occur within or 

adjacent to either project’s boundary. 

In accordance with the Commission’s 

regulations, on January 12, 2022, 

Commission staff issued separate 

notices that both the Hinckley-Jarvis 

and West Canada Creek projects were 

ready for environmental analysis (REA 

Notice).1 Based on the information in 

the projects’ records, including 

comments filed on the REA Notices, 

staff does not anticipate that licensing 

the projects would constitute a major 

federal action significantly affecting the 

quality of the human environment. 

However, because the Hinckley-Jarvis 

and West Canada Creek projects are 

located adjacent to each other in the 

same river basin and include similar 

issues, it is the Commission’s intent to 

continue to process these relicense 

applications concurrently. Therefore, 

staff intends to prepare a draft and final 

multi-project Environmental 

Assessment (EA) on the applications to 

relicense the Hinckley-Jarvis and West 

Canada Creek projects. 

The EA will be issued and circulated 

for review by all interested parties. All 

comments filed on the EA will be 

analyzed by staff and considered in the 

Commission’s final licensing decision. 

The applications will be processed 

according to the following schedule. 

Revisions to the schedule may be made 

as appropriate. 

Milestone Target date 

Commission issues draft EA December 

2022. 

Comments due on draft EA .. January 2023. 

Commission issues final EA June 2023.2

Any questions regarding this notice 

may be directed to Emily Carter at (202) 

502–6512 or emily.carter@ferc.gov. 

Dated: June 28, 2022. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2022–14109 Filed 6–30–22; 8:45 am] 

BILLING CODE 6717–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2016–0743; FRL–9943–01– 

OCSPP] 

n-Methylpyrrolidone (NMP); 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 nmethylpyrrolidone (NMP) risk 

evaluation issued under TSCA. The 

draft revision to the NMP 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 NMP, as a whole chemical 

substance, presents an unreasonable risk 

of injury to health when evaluated 

under its conditions of use. In addition, 

this draft 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 OSHA has 

not issued a permissible exposure limit 

(PEL) (as is the case for NMP). This 

revision, when final, would supersede 

the condition of use-specific no 

unreasonable risk determinations in the 

December 2020 NMP risk evaluation 

(and withdraw the associated order) and 

would make a revised determination of 

unreasonable risk for NMP as a whole 

chemical substance. 

DATES: Comments must be received on 

or before August 1, 2022. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–EPA–HQ–OPPT–2016– 

0743, using the Federal eRulemaking 

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

Follow the online instructions for 

submitting comments. Do not submit 

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: 

Clara Hull, Office of Pollution 

Prevention and Toxics (7404M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

564–3954; email address: hull.clara@

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 NMP, including NMP 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
39512 Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 

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 December 2020 NMP 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 NMP under TSCA, 

which was initially published in 

December 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 NMP, 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 

NMP 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 NMP 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 11 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, removing the assumption that 

workers always and appropriately wear 

PPE (see Unit II.C.) in making the whole 

chemical risk determination for NMP 

would result in three additional 

conditions of use to the original 26 

driving the unreasonable risk 

determination for NMP. Additionally, 

for five conditions of use, acute effects 

in addition to chronic effects would 

now drive the unreasonable risk to 

workers. Overall, 29 of the 37 

conditions of use EPA evaluated would 

drive the NMP whole chemical 

unreasonable risk determination due to 

risks identified for human health. The 

full list of the conditions of use 

evaluated for the NMP TSCA risk 

evaluation is in Table 1–6 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 

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 

https://www.epa.gov/dockets/ 

comments.html. 

II. Background 

A. Why is EPA re-issuing the risk 

determination for the NMP 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 29, HBCD, 1,4- 

dioxane, methylene chloride, NMP, 

perchloroethylene (PCE), and 

trichloroethylene (TCE). 

From June 2020 to January 2021, EPA 

published risk evaluations on the first 

ten chemical substances, including for 

NMP in December 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 

NMP, 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39513 

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 

NMP published in December 2020. 

First, following a review of specific 

aspects of the December 2020 NMP risk 

evaluation, EPA proposes that making 

an unreasonable risk determination for 

NMP 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 NMP 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 NMP the 

exposure pathways that were or could 

be regulated under another EPA 

administered statute were not fully 

assessed as part of the final risk 

evaluation (see section 1.4.2 of the 

December 2020 NMP risk evaluation). 

During problem formulation, EPA 

conducted a first-tier screening analysis 

for the ambient air pathway to near-field 

populations downwind from industrial 

and commercial facilities releasing NMP 

which indicated low risk. In the final 

risk evaluation EPA conducted a firsttier analysis to estimate NMP surface 

water concentrations and did not 

identify risks from incidental ingestion 

or dermal contact during swimming. 

This resulted in the ambient air and 

drinking water pathways for NMP not 

being fully assessed in the risk 

evaluation published in December 2020. 

The goal of the recently-developed 

screening approach is to provide for a 

more robust assessment of these 

pathways for NMP and to identify if 

there are risks that were unaccounted 

for in the NMP 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 NMP 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 NMP. 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 

NMP 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 (Ref. 9) stated: ‘‘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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
39514 Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 

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 NMP, as further 

explained in this notice, EPA proposes 

that a whole chemical approach is 

appropriate for NMP in order to protect 

health and the environment. The whole 

chemical approach is appropriate for 

NMP 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 and consumers and the 

irreversible health effects (specifically 

developmental post implantation fetal 

loss and reduced fertility and fecundity) 

associated with NMP 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 

NMP 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 NMP risk evaluation and the 

response to comments document (Ref. 

10). With respect to the NMP 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 NMP, 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 NMP as a whole 

chemical. Under the proposed revised 

approach, the ‘‘whole chemical’’ risk 

determination for NMP would 

supersede the no unreasonable risk 

determinations for NMP 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 December 2020 NMP risk 

evaluation. 

C. What revision does EPA propose 

about the use of PPE for the NMP 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 chemically resistant 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 December 2020 NMP risk 

evaluation, EPA assumed based on 

information provided by public 

comments and safety data sheets of 

NMP that workers use PPE— 

specifically, respirators with an APF 10 

and gloves with a PF ranging from 5 to 

10—for all occupational conditions of 

use. In the December 2020 NMP risk 

evaluation, EPA determined that there is 

unreasonable risk to these workers for 

25 of the 28 occupational COUs even 

with this assumed PPE use. 

EPA is revising the assumption for 

NMP 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39515 

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. 

Consistent with this approach, the 

December 2020 NMP 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 

NMP 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 EPA finds 

unreasonable risk for purposes of TSCA 

notwithstanding OSHA requirements. 

In accordance with this approach, 

EPA is proposing the draft revision to 

the NMP 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 public comments 

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 NMP and EPA invites 

comments on this draft change to the 

NMP 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 

workers always and appropriately wear 

PPE in making the whole chemical risk 

determination for NMP would result in 

three additional conditions of use 

driving EPA’s unreasonable risk 

determination for NMP as a whole 

chemical. The three conditions of use 

affected by this change are: industrial 

and commercial use in ink, toner, and 

colorant products; industrial and 

commercial use in other uses in 

soldering materials; and industrial and 

commercial use in other uses in 

fertilizer and other agricultural chemical 

manufacturing—processing aids and 

solvents. Additionally, for five 

conditions of use, acute effects in 

addition to chronic effects would now 

drive the unreasonable risk to workers 

(the five conditions of use are: 

processing for incorporation into 

articles in paint additives and coating 

additives not described by other codes 

in transportation equipment 

manufacturing; industrial and 

commercial use in paints, coatings, and 

adhesive removers; industrial and 

commercial use in paints and coatings 

in lacquers, stains, varnishes, primers, 

and floor finishes, powder coatings 

(surface preparation); industrial and 

commercial use paint additives and 

coating additives in multiple 

manufacturing sectors; and industrial 

and commercial use in adhesives and 

sealants including binding agents, single 

component glues and adhesives, 

including lubricant additives, twocomponent glues, and adhesives 

including some resins) (Ref. 1). 

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 NMP? 

NMP is a water-miscible, organic 

solvent that is often used as a substitute 

for halogenated solvents. NMP exhibits 

a unique set of physical and chemical 

properties that have proven useful in a 

range of industrial, commercial, and 

consumer applications. NMP has a wide 

range of uses, including in the 

production of paints and coatings, as a 

solvent for cleaning and degreasing, and 

in the manufacture of electronics. There 

are also a variety of consumer and 

commercial products that contain NMP, 

such as adhesives and sealants, as well 

as adhesive removers, automotive care 

products, and paints and coatings. NMP 

is both manufactured domestically and 

imported into the United States. 

E. What conclusions did EPA reach 

about the risks of NMP 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 NMP presents an 

unreasonable risk to health under the 

following conditions of use: 

• Domestic manufacture; 

• Manufacture (import); 


khammond on DSKJM1Z7X2PROD with NOTICES
39516 Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 

• Processing as a reactant or 

intermediate in plastic material and 

resin manufacturing and other nonincorporative processing; 

• Processing for incorporation into a 

formulation, mixture, or reaction 

product in multiple sectors; 

• Processing for incorporation into 

articles—in lubricants and lubricant 

additives in machinery manufacturing; 

• Processing for incorporation into 

articles in paint additives and coating 

additives not described by other codes 

in transportation equipment 

manufacturing; 

• Processing for incorporation into 

articles as a solvent (which become part 

of product formulation or mixture), 

including in textiles, apparel, and 

leather manufacturing; 

• Processing for incorporation into 

articles in other sectors, including in 

plastic product manufacturing; 

• Processing in recycling; 

• Processing for repackaging 

(wholesale and retail trade); 

• Industrial and commercial use in 

paints, coatings, and adhesive removers; 

• Industrial and commercial use in 

paints and coatings in lacquers, stains, 

varnishes, primers, and floor finishes, 

powder coatings (surface preparation); 

• Industrial and commercial use in 

paint additives and coating additives 

not described by other codes in 

computer and electronic product 

manufacturing in electronic parts 

manufacturing; 

• Industrial and commercial use paint 

additives and coating additives not 

described by other codes in computer 

and electronic product manufacturing in 

semiconductor manufacturing; 

• Industrial and commercial use paint 

additives and coating additives in 

multiple manufacturing sectors; 

• Industrial and commercial use as a 

solvent (for cleaning or degreasing) in 

electrical equipment, appliance and 

component manufacturing; 

• Industrial and commercial use as a 

solvent (for cleaning or degreasing) in 

electrical equipment appliance and 

component manufacturing in 

semiconductor manufacturing; 

• Industrial and commercial use in 

processing aids specific to petroleum 

production in petrochemical 

manufacturing, in other uses in oil and 

gas drilling, extraction, and support 

activities, and in functional fluids 

(closed systems); 

• Industrial and commercial use in 

adhesives and sealants including 

binding agents, single component glues 

and adhesives, including lubricant 

additives, two-component glues, and 

adhesives including some resins; 

• Industrial and commercial use in 

other uses in anti-freeze and de-icing 

products, automotive care products, and 

lubricants and greases; 

• Industrial and commercial use in 

metal products not covered elsewhere 

and lubricant and lubricant additives 

including hydrophilic coatings; 

• Industrial and commercial uses in 

other uses in laboratory chemicals; 

• Industrial and commercial uses in 

other uses in lithium ion battery 

manufacturing; 

• Industrial and commercial uses in 

other uses in cleaning and furniture care 

products including wood cleaners and 

gasket removers; 

• Consumer use in adhesives and 

sealants (glues and adhesives including 

lubricant adhesives); and 

• Disposal. 

Under the proposed whole chemical 

approach to the NMP risk 

determination, the unreasonable risk 

from NMP 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 

NMP, three conditions of use in 

addition to the original 26 would drive 

the unreasonable risk: 

• Industrial and commercial use in 

ink, toner, and colorant products 

(printer ink; inks in writing equipment); 

• Industrial and commercial use in 

other uses in soldering materials; 

• Industrial and commercial use in 

other uses in fertilizer and other 

agricultural chemical manufacturing in 

processing aids and solvents. 

Overall, 29 conditions of use out of 

the 37 evaluated would drive the NMP 

whole chemical unreasonable risk 

determination. 

III. Revision of the December 2020 Risk 

Evaluation 

A. Why is EPA proposing to revise the 

risk determination for the NMP risk 

evaluation? 

EPA is proposing to revise the risk 

determination for the NMP 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 NMP 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 NMP risk 

evaluation pursuant to TSCA section 

6(b). Under the revised determination, 

EPA preliminarily conclude that NMP, 

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 

previous unreasonable risk 

determinations made for NMP 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 

section 2.4.1.1 (Occupational Exposures 

Approach and Methodology) and 4.2.2 

(Risk Estimation for Worker Exposures 

for Occupational Use of NMP), of the 

NMP 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 2.4.1.1 and 4.2.2 

from the NMP 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 December 2020 risk evaluation) was 

not part of the scope of the peer review 

of the NMP 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 NMP risk 

evaluation because no technical or 

scientific changes will be made to the 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39517 

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 NMP risk 

evaluation and issue a final revised 

NMP 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 NMP risk 

evaluation. This final revised risk 

determination would supersede the 

December 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 NMP 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 NMP, Section 5, June 

2022. 

2. EPA. Risk Evaluation for nMethylpyrrolidone (NMP). EPA 

Document #740–R–18–009. December 

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

document/EPA-HQ-OPPT-2019-0236- 

0081. 

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 n-Methylpyrrolidone (NMP). 

December 2020. https://

www.regulations.gov/document/EPAHQ-OPPT-2019-0236-0082. 

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

Dated: June 27, 2022. 

Michal Freedhoff, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

[FR Doc. 2022–14108 Filed 6–30–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL OP–OFA–023] 

Environmental Impact Statements; 

Notice of Availability 

Responsible Agency: Office of Federal 

Activities, General Information 202– 

564–5632 or https://www.epa.gov/nepa. 

Weekly receipt of Environmental Impact 

Statements (EIS) 

Filed June 17, 2022 10 a.m. EST 

Through June 27, 2022 10 a.m. EST 

Pursuant to 40 CFR 1506.9. 

Notice 

Section 309(a) of the Clean Air Act 

requires that EPA make public its 

comments on EISs issued by other 

Federal agencies. EPA’s comment letters 

on EISs are available at: https://

cdxnodengn.epa.gov/cdx-enepa-public/ 

action/eis/search. 

EIS No. 20220086, Draft Supplement, 

NMFS, WA, The Makah Tribe Request 

to Hunt Gray Whales, Comment 

Period Ends: 08/15/2022, Contact: 

Grace Ferrara 206–526–6172. 

EIS No. 20220087, Final, FERC, LA, 

MP66–69 Compression Relocation 

and Modification Amendment MP33 

Compression Station Modification 

Amendment Project, Review Period 

Ends: 08/01/2022, Contact: Office of 

External Affairs 866–208–3372. 

EIS No. 20220088, Draft, USAF, WY, 

Ground Based Strategic Deterrent 

Deployment and Minuteman III 

Decommissioning and Disposal, 

Comment Period Ends: 08/15/2022, 

Contact: Carla Pampe 318–456–7844. 

EIS No. 20220089, Final, USACE, SC, 

Charleston Peninsula Coastal Storm 

Risk Management, Review Period 

Ends: 08/01/2022, Contact: Nancy 

Parrish 843–329–8050. 

EIS No. 20220090, Draft Supplement, 

DOE, AK, Alaska LNG Project, 

Comment Period Ends: 08/15/2022, 

Contact: Mark Lusk 304–285–4145. 

Amended Notice 

EIS No. 20190132, Draft Supplement, 

USFS, MT, WITHDRAWN— 

Montanore Evaluation Project, 

Comment Period Ends: 08/08/2019, 

Contact: Craig Towery 406–293–6211. 

Revision to FR Notice Published 06/ 

21/2019; Officially Withdrawn per 

request of the submitting agency. 

Dated: June 27, 2022. 

Cindy S. Barger, 

Director, NEPA Compliance Division, Office 

of Federal Activities. 

[FR Doc. 2022–14107 Filed 6–30–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2014–0125; FRL–9880–01– 

OCSPP] 

Pesticide Reregistration Performance 

Measures and Goals; Annual Progress 

Report for 2019; Notice of Availability 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces the 

availability of EPA’s progress report in 

meeting its performance measures and 

goals for pesticide reregistration during 

fiscal year 2019. This progress report 

also presents the total number of 

products registered under the ‘‘fasttrack’’ provisions of the Federal 

Insecticide Fungicide and Rodenticide 

Act (FIFRA). 

DATES: Submit comments on or before 

August 30, 2022. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0125, 

through the Federal eRulemaking Portal 

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

the online instructions for submitting 

comments. Do not submit 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: Rose 

Kyprianou, Antimicrobials Division 

(7510M), Office of Pesticide Programs, 


khammond on DSKJM1Z7X2PROD with NOTICES