12690 Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices 

well as a list of issues, based on the 

scoping process. 

Meeting Objectives 

At the scoping meetings, Commission 

staff will: (1) Initiate scoping of the 

issues; (2) review and discuss existing 

conditions; (3) review and discuss 

existing information and identify 

preliminary information and study 

needs; (4) review and discuss the 

process plan and schedule for pre-filing 

activity that incorporates the time 

frames provided for in Part 5 of the 

Commission’s regulations and, to the 

extent possible, maximizes coordination 

of federal, state, and tribal permitting 

and certification processes; and (5) 

discuss the potential of any federal or 

state agency or Indian tribe to act as a 

cooperating agency for development of 

an environmental document. Meeting 

participants should come prepared to 

discuss their issues and/or concerns. 

Please review the PAD in preparation 

for the scoping meetings. Directions on 

how to obtain a copy of the PAD and 

SD1 are included in item n of this 

document. 

Meeting Procedures 

Commission staff will be moderating 

the scoping meetings. The meetings will 

begin promptly at their respective start 

times listed above. 

At the start of the meeting, staff will 

provide further instructions regarding 

the meeting setup, agenda, and time 

period for comments and questions. We 

ask for your patience as staff present 

information and field participant 

comments in orderly manner. To 

indicate you have a question or 

comment, press * and 3 to virtually 

‘‘raise your hand’’. Oral comments will 

be limited to 5 minutes in duration for 

each participant. The meetings will be 

recorded by a stenographer and will be 

filed to the public record of the project. 

Please note, that if no participants 

join the meetings within 15 minutes 

after the start time, staff will end the 

meeting and conference call. The 

meetings will end after participants 

have presented their oral comments or 

at the specified end time, whichever 

occurs first. 

Dated: February 28, 2022. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2022–04686 Filed 3–4–22; 8:45 am] 

BILLING CODE 6717–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–9553–01–OMS] 

Cross-Media Electronic Reporting: 

Authorized Program Revision 

Approval, Nebraska Department of 

Environment and Energy (NDEE) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces the 

Environmental Protection Agency’s 

(EPA) approval of the Nebraska 

Department of Environment and Energy 

(NDEE) request to revise/modify certain 

of its EPA-authorized programs to allow 

electronic reporting. 

DATES: EPA approves the authorized 

program revisions/modifications as of 

March 7, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Shirley M. Miller, U.S. Environmental 

Protection Agency, Office of Information 

Management, Mail Stop 2824T, 1200 

Pennsylvania Avenue NW, Washington, 

DC 20460, (202) 566–2908, 

miller.shirley@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

October 13, 2005, the final Cross-Media 

Electronic Reporting Rule (CROMERR) 

was published in the Federal Register 

(70 FR 59848) and codified as part 3 of 

title 40 of the CFR. CROMERR 

establishes electronic reporting as an 

acceptable regulatory alternative to 

paper reporting and establishes 

requirements to assure that electronic 

documents are as legally dependable as 

their paper counterparts. Subpart D of 

CROMERR requires that state, tribal or 

local government agencies that receive, 

or wish to begin receiving, electronic 

reports under their EPA-authorized 

programs must apply to EPA for a 

revision or modification of those 

programs and obtain EPA approval. 

Subpart D provides standards for such 

approvals based on consideration of the 

electronic document receiving systems 

that the state, tribe, or local government 

will use to implement the electronic 

reporting. Additionally, § 3.1000(b) 

through (e) of 40 CFR part 3, subpart D 

provides special procedures for program 

revisions and modifications to allow 

electronic reporting, to be used at the 

option of the state, tribe or local 

government in place of procedures 

available under existing programspecific authorization regulations. An 

application submitted under the subpart 

D procedures must show that the state, 

tribe or local government has sufficient 

legal authority to implement the 

electronic reporting components of the 

programs covered by the application 

and will use electronic document 

receiving systems that meet the 

applicable subpart D requirements. 

On January 10, 2022, the Nebraska 

Department of Environment and Energy 

(NDEE) submitted an application titled 

NPDES Electronic Reporting Tool for 

Pesticide General Permit (NeTPGP) for 

revisions/modifications to its EPAapproved programs under title 40 CFR 

to allow new electronic reporting. EPA 

reviewed NDEE’s request to revise/ 

modify its EPA-authorized programs 

and, based on this review, EPA 

determined that the application met the 

standards for approval of authorized 

program revisions/modifications set out 

in 40 CFR part 3, subpart D. In 

accordance with 40 CFR 3.1000(d), this 

notice of EPA’s decision to approve 

NDEE’s request to revise/modify its 

following EPA-authorized programs to 

allow electronic reporting under 40 CFR 

is being published in the Federal 

Register: 

Part 123: EPA-Administered Permit 

Programs: The National Pollutant 

Discharge Elimination System 

(NPDES) Reporting under 40 CFR 122 

and 125 

NDEE was notified of EPA’s 

determination to approve its application 

with respect to the authorized programs 

listed above. 

Dated: March 1, 2022. 

Jennifer Campbell, 

Director, Office of Information Management. 

[FR Doc. 2022–04760 Filed 3–4–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2016–0725; FRL–9403–01– 

OCSPP] 

Colour Index Pigment Violet 29 (PV29); 

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 requesting public 

comment on a draft revision to the risk 

determination for the Colour Index 

Pigment Violet 29 (PV 29) risk 

evaluation issued under TSCA. The 

draft revision to the PV 29 risk 

determination was developed following 

a review of the first ten risk evaluations 

issued under TSCA that was done in 


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accordance with Executive Orders and 

other Administration priorities, 

including those on environmental 

justice, scientific integrity, and 

regulatory review, and this draft 

revision 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. Specifically, in this 

draft revision to the risk determination 

EPA finds that PV 29, as a whole 

chemical substance, presents an 

unreasonable risk of injury to health 

when evaluated under its conditions of 

use. This draft revision would 

supersede the condition of use-specific 

no unreasonable risk determinations in 

the January 2021 PV 29 risk evaluation 

(and withdraw the associated order) and 

make a revised determination of 

unreasonable risk for PV 29 as a whole 

chemical substance. In addition, this 

draft revised risk determination does 

not reflect an assumption that workers 

always appropriately wear personal 

protective equipment (PPE). 

DATES: Comments must be received on 

or before April 21, 2022. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–EPA–HQ–OPPT–2016– 

0725, 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. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

by appointment only. For the latest 

status information on EPA/DC services 

and docket access, visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Todd Coleman, Office of Pollution 

Prevention and Toxics (7404T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

564–1208; email address: 

Coleman.Todd@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 PV 29, including PV 29 in 

products. Since other entities may also 

be interested in this draft revision to the 

risk determination, the 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 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). 

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 PV 29 under TSCA, 

published in January 2021 (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 PV 29, as a whole chemical, 

presents an unreasonable risk of injury 

to health when evaluated under its 

conditions of use. This whole chemical 

approach to determining unreasonable 

risk to health is permissible under 

EPA’s statutory obligations under TSCA 

section 6(b)(4) and the implementing 

regulations and would revise and 

replace section 5 of the risk evaluation 

for PV 29 where the findings of 

unreasonable risk to health were 

previously made for the individual 

conditions of use evaluated. 

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 ten conditions of use 

would continue to drive the 

unreasonable risk determination for PV 

29. Removing the assumptions of PPE 

use in making the whole chemical risk 

determination for PV 29 would not alter 

the conditions of use or worker 

subpopulations that drive the 

unreasonable risk determination for PV 

29. Overall, ten conditions of use drive 

the PV 29 whole chemical unreasonable 

risk determination due to risks 

identified for human health. The full list 

of the conditions of use evaluated for 

the PV 29 risk evaluation is in Table 5– 

1 of the risk evaluation (Ref. 1). 


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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 

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

comments.html. 

II. Background 

A. Why is EPA re-issuing the risk 

determination for the PV 29 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 (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 

PV 29 in January 2021. The risk 

evaluations included individual 

unreasonable risk determinations for 

each condition of use evaluated. The 

determinations that particular 

conditions of use did not present an 

unreasonable risk were issued by order 

under TSCA section 6(i)(1). 

In accordance with Executive Order 

13990 (Ref. 2) and other Administration 

priorities (Refs. 3, 4, and 5), EPA is 

reviewing the risk evaluations for the 

first ten chemical substances 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 available here 

https://www.epa.gov/newsreleases/epaannounces-path-forward-tsca-chemicalrisk-evaluations. To that end, EPA is 

reconsidering two key aspects of the risk 

determinations for PV 29 published in 

January 2021. First, based on EPA’s 

review, EPA proposes that the 

appropriate approach to these 

determinations under the statute and 

implementing regulations is to make an 

unreasonable risk determination for PV 

29 as a whole chemical substance, 

rather than making unreasonable risk 

determinations separately on each 

individual condition of use evaluated in 

the risk evaluation. 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; 

rather, the use of PPE would be 

considered during risk management. 

This action pertains only to the risk 

determination for PV 29. 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. To the extent the Agency 

deems appropriate, additional actions 

may follow that are specific to each of 

the chemical substances for which EPA 

has issued final risk evaluations under 

TSCA section 6. 

B. What is a whole chemical view of the 

unreasonable risk determination for the 

PV 29 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. EPA acknowledges a 

lack of specificity in the statute and 

inconsistency in the regulations with 

respect to the presentation of risk 

determinations in TSCA risk 

evaluations. 

The proposed risk evaluation 

procedural rule was premised on the 

whole chemical approach to making 

unreasonable risk determinations (Ref. 

6). EPA acknowledged a lack of 

specificity in 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). The proposed rule, however, 

was unambiguous on the point that 

unreasonable risk determinations would 

be for the chemical substance as a 

whole, even if based on a subset of uses. 

(See Ref. 6 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 as identified in the final scope 

document . . .’’ (Ref. 6 at pg. 7480). 

As stated in the final risk evaluation 

procedural rule (Ref. 7): ‘‘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: ‘‘The final step of a risk 

evaluation is for EPA to determine 

whether the chemical substance, under 

the conditions of use, presents an 

unreasonable risk of injury to health or 

the environment. EPA will make 

individual risk determinations for all 

uses identified in the scope. This part of 

the regulation is slightly amended from 


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the proposed rule, to clarify that the risk 

determination is part of the risk 

evaluation, as well as to account for the 

revised approach to that [sic] ensures 

each condition of use covered by the 

risk evaluation receives a risk 

determination.’’ (Ref. 7 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 above 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. 

7, 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 states: ‘‘[t]he 

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 of injury to health or 

the environment.’’ 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. 7 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-bycase 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. For 

instance, circumstances in which an 

unreasonable risk determination is 

primarily driven by a single condition of 

use that does not impact or intersect 

with other evaluated uses (such as for 

example, a single consumer use of a 

substance out of a wide range of other 

manufacturing, processing and 

consumer uses evaluated) may warrant 

different treatment than circumstances 

in which the majority of the chemical 

substance’s conditions of use contribute 

to unreasonable risk, and the Agency 

might adopt different approaches to the 

risk determinations in those particular 

instances. EPA anticipates that this 

flexibility will better serve TSCA’s 

objectives by helping ensure that EPA is 

best positioned to present, and initiate 

risk management to address, chemicalspecific unreasonable risk 

determinations. EPA believes this is a 

reasonable approach under TSCA and 

the Agency’s implementing regulations. 

With regard to the specific 

circumstances of PV 29, as further 

explained in this notice, EPA proposes 

that a whole chemical approach better 

aligns with TSCA’s objective of 

protecting health and the environment. 

For PV 29, EPA favors the whole 

chemical approach based in part on the 

benchmark exceedances for multiple 

conditions of use (spanning across most 

aspects of the chemical lifecycle—from 

manufacturing (including import), 

processing, commercial and industrial 

use, and disposal) for health of workers 

and occupational non-users and the 

irreversible health effects (specifically 

alveolar hyperplasia) associated with PV 

29 exposures. Since the chemicalspecific properties cut across the 

conditions of use within the scope of 

the risk evaluation, the Agency’s risk 

findings and conclusions encompass the 

majority of those conditions of use, and 

the Agency is better positioned to 

achieve its TSCA objectives for PV 29 

when issuing a whole chemical 

determination for PV 29, EPA concludes 

that the Agency’s risk determination for 

PV 29 is better characterized as a whole 

chemical risk determination rather than 

condition-of-use-specific risk 

determinations. 

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 

document and in the accompanying 

draft revision to the risk determination 

would supersede any conflicting 

statements in the prior PV 29 risk 

evaluation and the response to 

comments document (Ref.). With 

respect to the PV 29 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 PV 29, including a list 

of the condition-of-use-specific risks 

driving the unreasonable risk 

determination for the chemical 

substance as a whole. For purposes of 

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

determination on PV 29 as a whole 

chemical. Under the revised approach, 

EPA is proposing to supersede the no 

unreasonable risk determinations (and 

withdraw the associated order) for PV 

29 that were premised on a conditionof-use-specific approach to determining 

unreasonable risk. 


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C. What revision does EPA propose 

about the use of PPE for the PV 29 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 protection factor (PF) for dermal 

protection. In support of this 

assumption, EPA used 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 January 2021 PV 29 risk 

evaluation, EPA assumed based on 

information provided by the 

manufacturer of PV 29 that workers use 

PPE—specifically, respirators with an 

APF ranging from 10 to 25—for eight 

conditions of use. However, in the 

January 2021 PV 29 risk evaluation, EPA 

determined that there is unreasonable 

risk to these workers even with this 

assumed PPE use. 

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 no mitigation 

measures are assumed to be in place. 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. This 

approach considers the risk to 

potentially exposed or susceptible 

subpopulations of workers 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. 

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 

January 2021 PV 29 risk evaluation 

characterized risk to workers both with 

and without the use of PPE. 

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 practice is 

sufficient to address the risk, applicable 

to all potentially exposed workers, or 

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. Additionally, as 

previously noted, self-employed 

individuals and public sector workers 

who are not covered by a State Plan are 

not covered by OSHA requirements. 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. 

Therefore, going forward, EPA intends 

to make its determination of 

unreasonable risk 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 proposes that the draft revision to 

the PV 29 risk determination not rely on 

assumptions regarding the occupational 

use of PPE in making the unreasonable 

risk determination under TSCA section 

6; rather, the use of PPE would be 

considered during risk management. 

This would represent a change from the 

approach taken in the 2021 risk 

evaluation for PV 29 and EPA invites 

comments on this draft change to the 

PV29 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 

unreasonable risk; ensure the EPA 

requirements apply to all potentially 

exposed workers; and develop 

occupational risk mitigation measures to 

address any unreasonable risks 

identified by EPA. 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. 

By removing the assumptions of PPE 

use in making the whole chemical risk 

determination for PV 29 would not alter 

the conditions of use that drive EPA’s 

unreasonable risk determination for PV 

29 as a whole chemical. 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 PV 29? 

PV 29 is a high color strength, 

weather fast and heat stable pigment 

used in various industrial, commercial, 

and consumer applications. Domestic 

manufacture of PV 29 is conducted by 

a sole manufacturer. Imported PV 29 

pigment, without being processed into a 

different product, makes up a very small 

market share of the PV 29 supply chain. 


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Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices 12695 

Leading applications for C.I. Pigment 

Violet 29 include use as an intermediate 

to create or adjust color of other 

perylene pigments, incorporation into 

paints and coatings used primarily in 

the automobile industry, incorporation 

into plastic and rubber products used 

primarily in automobiles and industrial 

carpeting, use in merchant ink for 

commercial printing, and use in 

consumer watercolors and artistic color. 

E. What conclusions did EPA reach 

about the risks of PV 29 in the TSCA 

risk evaluation based on the whole 

chemical approach and not assuming 

the use of PPE? 

EPA determined that PV 29 presents 

an unreasonable risk to health driven by 

risk associated with the following 

conditions of use: Manufacture 

(including import); processing 

(incorporation into formulation, 

mixture, or reaction products including 

paints and coatings and plastic and 

rubber products; processing as an 

intermediate in the creation of 

adjustment of color or other perylene 

pigments; and recycling); industrial/ 

commercial use of PV 29 in automotive 

(Original Equipment Manufacture 

(OEM) and refinishing) paints and 

coatings, coatings and basecoats, and 

merchant ink for commercial printing; 

and disposal of PV 29. By removing the 

assumption of PPE use in making the 

whole chemical risk determination for 

PV 29, there are no additional 

conditions of use or worker 

subpopulations that would drive the 

draft unreasonable risk determination. 

The same ten COUs would continue to 

drive EPA’s unreasonable risk 

determination. 

III. Revision of the January 2021 Risk 

Evaluation 

A. Why is EPA proposing to revise the 

risk determination for the PV 29 risk 

evaluation? 

EPA is proposing to revise the risk 

determination for the PV 29 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. 1, 3, and 4). EPA plans to consider 

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 PV 29 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 (which 

would result in the new determination 

superseding the determinations and the 

withdrawal of the associated order of no 

unreasonable risk for the conditions of 

use identified in the no unreasonable 

risk order), and (2) clarifying that the 

risk determination does not rely on 

assumed use of PPE. 

B. What are the draft revisions? 

EPA is releasing a draft revision of the 

risk determination for the PV 29 risk 

evaluation pursuant to TSCA section 

6(b). Under the revised determination, 

EPA proposes to conclude that PV 29, 

as evaluated in the risk evaluation as a 

whole, presents an unreasonable risk of 

injury to health when evaluated under 

its conditions of use. This revision 

would replace the previous 

unreasonable risk determinations made 

for PV 29 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 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 2.3.1.4 (Consideration of 

Engineering Controls and PPE), 

paragraph four, of the PV 29 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 

section 2.3.1.4 from the PV 29 risk 

evaluation and the response to 

comments document (Ref. 8). 

Additional policy changes to other 

chemical risk evaluations, including any 

consideration of potentially exposed 

and 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 January 2021 risk evaluation) was 

not part of the scope of the peer reviews 

of the first ten chemicals by the Science 

Advisory Committee on Chemicals 

(SACC). Thus, consistent with that 

approach, EPA does not intend to 

conduct peer review for the draft 

revised unreasonable risk determination 

for the PV 29 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 PV 29 risk 

evaluation and, after considering those 

public comments, issue the revised final 

PV 29 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 2021 PV29 risk 

evaluation. This final revised risk 

determination would supersede the 

January 2021 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 PV 

29 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 Risk Evaluation for C.I. Pigment 

Violet 29. EPA Document #740–R–18– 

015. January 2021. https://www.epa.gov/ 

sites/default/files/2021-01/documents/1_

final_risk_evaluation_for_c.i._pigment_

violet_29.pdf. 

2. 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. 

3. Executive Order 13985. Advancing Racial 

Equity and Support for Underserved 

Communities Through the Federal 

Government. Federal Register. 86 FR 

7009, January 25, 2021. 

4. Executive Order 14008. Tackling the 

Climate Crisis at Home and Abroad. 

Federal Register. 86 FR 7619, February 

1, 2021. 

5. Presidential Memorandum. Memorandum 

on Restoring Trust in Government 

Through Scientific Integrity and 

Evidence-Based Policymaking. Federal 

Register. 86 FR 8845, February 10, 2021. 

6. EPA. Proposed Rule; Procedures for 

Chemical Risk Evaluation Under the 

Amended Toxic Substances Control Act. 


khammond on DSKJM1Z7X2PROD with NOTICES
12696 Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices 

Federal Register. 82 FR 7562, January 

18, 2017 (FRL–9957–75). 

7. 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). 

8. EPA. Summary of External Peer Review 

and Public Comments and Disposition 

for C.I. Pigment Violet 29 (PV29) 

(Anthra[2,1,9-def:6,5,10- 

d′e′f′]diisoquinoline-1,3,8,10(2H,9H)- 

tetrone). January 2021. https://

www.regulations.gov/document/EPAHQ-OPPT-2018-0604-0126. 

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

Michael S. Regan, 

Administrator. 

[FR Doc. 2022–04672 Filed 3–4–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2018–0443; FRL–8850–02– 

OCSPP] 

Octamethylcyclotetra-siloxane (D4); 

Final Scope of the Risk Evaluation To 

Be Conducted Under the Toxic 

Substances Control Act (TSCA); Notice 

of Availability 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: In accordance with the Toxic 

Substances Control Act (TSCA) and 

implementing regulations, EPA is 

announcing the availability of the final 

scope of the risk evaluation to be 

conducted for octamethylcyclotetrasiloxane (D4) (Cyclotetrasiloxane, 

2,2,4,4,6,6,8,8-octamethyl-; Chemical 

Abstracts Service Registry Number 

(CASRN) 556–67–2), a chemical 

substance for which EPA received a 

manufacturer request for risk 

evaluation. The scope document 

includes the conditions of use, hazards, 

exposures, and the potentially exposed 

or susceptible subpopulations that EPA 

plans to consider in conducting the risk 

evaluation for this chemical substance. 

ADDRESSES: The docket, identified by 

docket identification (ID) number EPA– 

HQ–OPPT–2018–0443, is available 

online at https://www.regulations.gov or 

in-person at the Office of Pollution 

Prevention and Toxics Docket (OPPT 

Docket), Environmental Protection 

Agency Docket Center (EPA/DC), West 

William Jefferson Clinton Bldg., Rm. 

3334, 1301 Constitution Ave. NW, 

Washington, DC. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

open to visitors by appointment only. 

For the latest status information on 

EPA/DC services and docket access, 

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

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Bethany Masten, Existing Chemical Risk 

Management Division, Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency 

(Mailcode 7404T), 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–8803; 

email address: masten.bethany@

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. General Information 

A. Does this action apply to me? 

This action is directed to the public 

in general and may be of interest to 

entities that manufacture (including 

import) a chemical substance regulated 

under TSCA (e.g., entities identified 

under North American Industrial 

Classification System (NAICS) codes 

325 and 324110). The action may also 

be of interest to chemical processors, 

distributors in commerce, and users; 

non-governmental organizations in the 

environmental and public health 

sectors; state and local government 

agencies; and members of the public. 

Since other entities may also be 

interested, the Agency has not 

attempted to describe all the specific 

entities and corresponding NAICS codes 

for entities that may be interested in or 

affected by this action. 

B. What is the Agency’s authority for 

taking this action? 

The final scope document is issued 

pursuant to TSCA section 6(b)(4)(D) and 

TSCA implementing regulations at 40 

CFR 702.41(c)(8). 

C. What action is the Agency taking? 

EPA is publishing the final scope of 

the risk evaluation for D4 under TSCA. 

Through the risk evaluation process, 

EPA will determine whether the 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment under the conditions of 

use, in accordance with TSCA section 

6(b)(4). 

II. Background 

TSCA allows chemical manufacturers 

to request an EPA-conducted risk 

evaluation of a chemical substance 

under 40 CFR 702.37. On March 19, 

2020, EPA received a manufacturer 

request for a risk evaluation of D4 (Ref. 

1). On June 17, 2020, EPA opened a 45- 

day public comment period to gather 

information relevant to the requested 

risk evaluation. EPA granted the request 

on October 6, 2020, and subsequently 

initiated the scoping process for the risk 

evaluation for this chemical substance. 

Pursuant to 40 CFR 702.41(c)(7), EPA 

announced the availability of and 

sought public comment on the draft 

scope document for the risk evaluation 

to be conducted for D4 under TSCA (86 

FR 50347, September 8, 2021) (FRL– 

8850–01–OCSPP) (Ref. 2). 

The purpose of risk evaluation is to 

determine whether a chemical 

substance, or category of chemical 

substances, presents an unreasonable 

risk of injury to health or the 

environment, under the conditions of 

use, including an unreasonable risk to a 

relevant potentially exposed or 

susceptible subpopulation (15 U.S.C. 

2605(b)(4)(A)). As part of this process, 

EPA must evaluate both hazards and 

exposures for the conditions of use; 

describe whether aggregate or sentinel 

exposures were considered and the 

basis for consideration; not consider 

costs or other nonrisk factors; take into 

account, where relevant, likely duration, 

intensity, frequency, and number of 

exposures and describe the weight of 

the scientific evidence for hazards and 

exposures (15 U.S.C. 2605(b)(4)(F)). This 

process will culminate in a 

determination of whether the chemical 

substance presents an unreasonable risk 

of injury to health or the environment 

under the conditions of use (15 U.S.C. 

2605(b)(4)(A); 40 CFR 702.47). 

III. Information and Comments 

Received on the Draft Scope 

In the Federal Register of September 

8, 2021 (Ref. 2), EPA announced the 

availability of the draft scope document 

for the risk evaluation to be conducted 

for D4 under TSCA and invited public 

comments on EPA’s draft scope 

document, including additional data or 

information relevant to the chemical 

substance or that otherwise could be 

useful to the Agency in finalizing the 

scope of the risk evaluation. To the 

extent that comments provided 

information on conditions of use, as 

well as other elements of the draft scope 

document, those comments and other 

submitted information (e.g., relevant 

studies, assessments, information on 

degradation products, and information 

on conditions of use) were used to 

inform revisions to the draft scope 

document and may be considered in 


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