Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Proposed Rules 3107 

with Plan B, and Plan A is the surviving 

plan in the merger. 

(B) Analysis and conclusion. The 

merger is a merger of a plan described 

in paragraph (e)(1)(i) of this section with 

a plan that is not described in paragraph 

(e)(1)(i) of this section and is not a 

merger described in paragraph (e)(3)(ii) 

or (4) of this section. Under paragraph 

(e)(3)(i)(A) of this section, Plan A will 

no longer be a plan described in 

paragraph (e)(1)(i) of this section and 

will be subject to paragraph (b) of this 

section after the merger (unless an 

exception described in paragraph (d)(4) 

of this section, relating to new or small 

businesses, applies to Employer R). 

(ii) Example 2—(A) Facts. The facts 

are the same as in paragraph (e)(7)(i) of 

this section (Example 1), except that 

there is an acquisition described in 

§ 1.410(b)–2(f), and the plan merger 

occurs within the transition period 

described in section 410(b)(6)(C)(ii). 

(B) Analysis and conclusion. The 

merger satisfies the requirements of 

paragraph (e)(3)(ii) of this section. 

Accordingly, Plan A will continue to be 

excepted from paragraph (b) of this 

section as a plan described in paragraph 

(e)(1)(i) of this section after the merger. 

(iii) Example 3—(A) Facts. Plan C, a 

multiple employer plan, was established 

on January 1, 2021. Plan D, a plan 

maintained by Employer T that is not a 

multiple employer plan, was adopted on 

January 1, 2024. Plan D merges with 

Plan C on December 31, 2024. 

(B) Analysis and conclusion. The 

merger is described in paragraph 

(e)(4)(i) of this section and because Plan 

D is not a plan described in paragraph 

(e)(1)(i) of this section, the merger is not 

excepted under paragraph (e)(4)(ii) of 

this section. Similarly, because there 

was no transaction described in 

§ 1.410(b)–2(f), the merger is not 

described in paragraph (e)(3)(iii) of this 

section. Accordingly, with respect to 

Employer T, Plan C will not be a plan 

described in paragraph (e)(1)(i) of this 

section and will be subject to paragraph 

(b) of this section after the merger 

(unless an exception described in 

paragraph (d)(4) of this section, relating 

to new or small businesses, continues to 

apply to Employer T). However, under 

paragraph (e)(4)(iii) of this section, the 

merger does not affect whether Plan C 

is treated as a plan described in 

paragraph (e)(1)(i) of this section with 

respect to any other employers. 

(iv) Example 4—(A) Facts. Plan E, a 

plan maintained by Employer U that is 

not a multiple employer plan, was 

adopted on January 1, 2021. Plan F, a 

multiple employer plan, was established 

on January 1, 2024. Plan E merges with 

Plan F on December 31, 2024. 

(B) Analysis and conclusion. Under 

paragraph (e)(4)(ii) of this section, the 

portion of Plan F that applies with 

respect to Employer U will continue to 

be excepted from paragraph (b) of this 

section as a plan described in paragraph 

(e)(1)(i) of this section after the merger. 

However, under paragraph (e)(4)(iii) of 

this section, the merger does not affect 

whether Plan F is treated as a plan 

described in paragraph (e)(1)(i) of this 

section with respect to any other 

employers. 

(v) Example 5—(A) Facts. Plan G, a 

plan maintained by Employer V that is 

not a multiple employer plan, was 

adopted on January 1, 2021. Plan G is 

amended, effective January 1, 2026, to 

add an additional participating 

employer, a subsidiary that is 100 

percent owned by Employer V. 

(B) Analysis and conclusion. Because 

the expansion of eligibility is not an 

amendment relating to an action 

described in paragraph (e)(2), (3), or (4) 

of this section, Plan G will continue to 

be excepted from paragraph (b) of this 

section as a plan described in paragraph 

(e)(1)(i) of this section after the 

amendment pursuant to paragraph 

(e)(6)(i) of this section. 

(vi) Example 6—(A) Facts. Plan J, a 

multiple employer plan, was established 

on January 1, 2021. Employer W adopts 

Plan J on January 1, 2022. Effective 

January 1, 2026, the assets and account 

balances attributable to the employees 

of Employer W are spun off to form a 

new plan, Plan K, maintained solely by 

Employer W. 

(B) Analysis and Conclusion. Under 

paragraph (e)(5)(ii) of this section, Plan 

K will be excepted from paragraph (b) 

of this section as a plan described in 

paragraph (e)(1)(i) of this section. 

(f) Applicability dates—(1) Statutory 

applicability date. Section 414A applies 

to plan years beginning after December 

31, 2024. 

(2) Regulatory applicability date. This 

section applies to plan years beginning 

after [DATE SIX MONTHS AFTER 

DATE OF PUBLICATION OF FINAL 

RULE]. For earlier plan years, a plan is 

treated as having complied with section 

414A if the plan complies with a 

reasonable, good faith interpretation of 

section 414A. 

Douglas W. O’Donnell, 

Deputy Commissioner. 

[FR Doc. 2025–00501 Filed 1–10–25; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 751 

[EPA–HQ–OPPT–2021–0277; FRL–8331–02– 

OCSPP] 

RIN 2070–AK87 

C.I. Pigment Violet 29 (PV29); 

Regulation Under the Toxic 

Substances Control Act (TSCA) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA or Agency) is proposing to 

address the unreasonable risk of injury 

to human health presented by C.I. 

Pigment Violet 29 (CASRN 81–33–4, 

also known as PV29), under its 

conditions of use as documented in 

EPA’s January 2021 Risk Evaluation for 

PV29 and the September 2022 Revised 

Risk Determination for PV29 prepared 

under TSCA. TSCA requires that EPA 

address by rule any unreasonable risk of 

injury to health or the environment 

identified in a TSCA risk evaluation and 

apply requirements to the extent 

necessary so the chemical no longer 

presents unreasonable risk. To address 

the identified unreasonable risk, EPA is 

proposing requirements to protect 

workers from the unreasonable risk of 

PV29 during manufacturing and 

processing, certain industrial and 

commercial uses of the chemical, and 

disposal, while also allowing for a 

reasonable transition period prior to 

enforcement of said requirements. 

DATES: Comments must be received on 

or before February 28, 2025. Under the 

Paperwork Reduction Act (PRA), 

comments on the information collection 

provisions are best assured of 

consideration if the Office of 

Management and Budget (OMB) 

receives a copy of your comments on or 

before February 13, 2025. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2021–0277, 

online 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 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

FOR FURTHER INFORMATION CONTACT: 


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3108 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Proposed Rules 

For technical information: Carolyn 

Mottley, Existing Chemicals Risk 

Management Division (7404M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number (202) 

566–1955; email address: 

mottley.carolyn@epa.gov. 

For general information: The TSCAHotline, 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? 

You may be potentially affected by 

this action if you manufacture (defined 

under TSCA to include import), process, 

distribute in commerce, use, or dispose 

of PV29. The following list of North 

American Industrial Classification 

System (NAICS) codes is not intended 

to be exhaustive, but rather provides a 

guide to help readers determine whether 

this document applies to them. 

Potentially affected entities include: 

• Synthetic Dye and Pigment 

Manufacturing (NAICS code 325130); 

• Plastics Material and Resin 

Manufacturing (NAICS code 325211); 

• Other Basic Inorganic Chemical 

Manufacturing (NAICS code 325180); 

• Paint and Coating Manufacturing 

(NAICS code 325510); 

• Custom Compounding of Purchased 

Resins (NAICS code 325991); 

• Automobile and Light Duty Motor 

Vehicle Manufacturing (NAICS code 

336110); 

• Motor Vehicle Body Manufacturing 

(NAICS code 336211); 

• Automotive Body, Paint, and 

Interior Repair and Maintenance 

(NAICS code 811121); 

• Printing Ink Manufacturing (NAICS 

code 325910); 

• Motor Vehicle Parts (Used) 

Merchant Wholesalers (NAICS code 

423140); 

• Recyclable Material Merchant 

Wholesalers (NAICS code 423930); 

• Carpet and Rug Mills (NAICS code 

314110); 

• All Other Miscellaneous Textile 

Product Mills (NAICS code 314999); 

• Artificial and Synthetic Fibers and 

Filaments Manufacturing (NAICS code 

325220); 

• Floor Covering Retailers (NAICS 

code 449121); 

• Materials Recovery Facilities 

(NAICS code 562920); 

• Sewage Treatment Facilities 

(NAICS code 221320); 

• Solid Waste Collection (NAICS 

code 562111); 

• Solid Waste Landfill (NAICS code 

562212; 

• Solid Waste Combustors and 

Incinerators (NAICS code 562213); and 

• Other Nonhazardous Waste 

Treatment and Disposal (NAICS code 

562219). 

This action may also affect certain 

entities subject to import certification 

and export notification rules under 

TSCA (https://www.epa.gov/tscaimport-export-requirements). Persons 

who import any chemical substance in 

bulk form, as part of a mixture, or as 

part of an article (if required by rule) are 

subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements and the corresponding 

regulations at 19 CFR 12.118 through 

12.127; see also 19 CFR 127.28. Those 

persons must certify that the shipment 

of the chemical substance complies with 

all applicable rules and orders under 

TSCA. The EPA policy in support of 

import certification appears at 40 CFR 

part 707, subpart B. In addition, any 

persons who export or intend to export 

a chemical substance that is the subject 

of this proposed rule are subject to the 

export notification provisions of TSCA 

section 12(b) (15 U.S.C. 2611(b)) and 

must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

If you have any questions regarding 

the applicability of this proposed action 

to a particular entity, consult the 

technical information contact listed 

under FOR FURTHER INFORMATION

CONTACT. 

B. What is the Agency’s authority for 

taking this action? 

Under TSCA section 6(a) (15 U.S.C. 

2605(a)), if EPA determines through a 

TSCA section 6(b) risk evaluation that a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, EPA must by rule 

apply one or more requirements listed 

in TSCA section 6(a) to the extent 

necessary so that the chemical 

substance or mixture no longer presents 

such risk. 

C. What action is the Agency taking? 

Pursuant to TSCA section 6(b), EPA 

determined that PV29 presents an 

unreasonable risk of injury to health, 

without consideration of costs or other 

nonrisk factors, including an 

unreasonable risk to potentially exposed 

or susceptible subpopulations (PESS) 

identified as relevant to the Risk 

Evaluation for C.I. Pigment Violet 29 

(2021 Risk Evaluation for PV29), under 

the conditions of use (Refs. 1, 2). The 

term ‘‘conditions of use’’ is defined in 

TSCA section 3(4) (15 U.S.C. 2602(4)) to 

mean the circumstances under which a 

chemical substance is intended, known, 

or reasonably foreseen to be 

manufactured, processed, distributed in 

commerce, used, or disposed of. A 

detailed description of the conditions of 

use that contribute to EPA’s 

determination that PV29 presents an 

unreasonable risk is provided in Unit 

III.B. Accordingly, to address the 

unreasonable risk, EPA is proposing, 

under TSCA section 6(a) to: 

(i) Require use of assigned protection 

factor (APF) 50 respirators and 

equipment and area cleaning to address 

the risk from inhalation exposure to dry 

powder PV29 (also referred to as 

regulated PV29), where dry powder 

PV29 is expected to be present, for the 

following conditions of use, as outlined 

in Unit IV.A.1: 

• Domestic manufacture; 

• Import; 

• Incorporation into formulation, 

mixture or reaction products in paints 

and coatings; 

• Incorporation into formulation, 

mixture or reaction products in plastic 

and rubber products; and 

• Intermediate in the creation or 

adjustment of color of other perylene 

pigments; 

• Recycling; 

• Industrial and commercial use in 

automobile (original equipment 

manufacturer (OEM) and refinishing) 

paints and coatings; 

• Industrial and commercial use in 

coatings and basecoats paints and 

coatings; 

• Industrial and commercial use in 

merchant ink for commercial printing; 

and 

• Disposal. 

(ii) Require manufacturers (including 

importers), processors, and distributors 

in commerce of regulated PV29 to 

provide downstream notification of the 

requirements, as outlined in Unit 

IV.A.2. 

(iii) Require recordkeeping, as 

outlined in Unit IV.A.2. 

EPA notes that not all TSCA 

conditions of use of PV29 are subject to 

this proposal. As described in the 2021 

Risk Evaluation for C.I. Pigment Violet 

29 (Ref. 1) and the September 2022 

revised unreasonable risk determination 

(Ref. 2), four conditions of use of PV29 

do not contribute to the unreasonable 

risk: distribution in commerce; 

industrial/commercial use in plastic and 

rubber products—automobile plastics; 

industrial/commercial use in plastic and 

rubber products—industrial carpeting; 

and consumer use in professional 

quality watercolor and acrylic artist 

paint. Consumer use in professional 

quality watercolor and acrylic artist 


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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Proposed Rules 3109 

paint was the only consumer condition 

of use evaluated as part of the 2021 

PV29 Risk Evaluation. EPA is requesting 

public comment on all aspects of this 

proposal. 

D. Why is the Agency taking this action? 

Under TSCA section 6(a), ‘‘[i]f the 

Administrator determines in accordance 

with subsection (b)(4)(A) that the 

manufacture, processing, distribution in 

commerce, use or disposal of a chemical 

substance or mixture, or that any 

combination of such activities, presents 

an unreasonable risk of injury to health 

or the environment, the Administrator 

shall by rule . . . apply one or more of 

the [section 6(a)] requirements to such 

substance or mixture to the extent 

necessary so that the chemical 

substance or mixture no longer presents 

such risk.’’ PV29 was the subject of a 

risk evaluation under TSCA section 

6(b)(4)(A) that was issued in January 

2021 (Ref. 1). In addition, EPA issued a 

revised unreasonable risk determination 

for PV29 in September 2022 (Ref. 2), 

determining that PV29, through a single 

risk determination for the chemical 

substance under its conditions of use, 

presents an unreasonable risk of injury 

to health under the conditions of use. 

As a result, EPA is proposing to take 

action to the extent necessary so that 

PV29 no longer presents such risk. The 

unreasonable risk and the conditions of 

use that contribute to the unreasonable 

risk are described in Unit III.B. 

The 2022 Revised Unreasonable Risk 

Determination for C.I. Pigment Violet 29 

reaffirmed that the same 10 conditions 

of use found to present unreasonable 

risk of injury to health in the 2021 Risk 

Evaluation for C.I. Pigment Violet 29 

contribute to the unreasonable risk of 

injury to health as a single chemical 

substance. As part of the rulemaking 

process, EPA is required to assess the 

potential impact of its regulations on 

small businesses through the Small 

Business Regulatory Enforcement 

Fairness Act (SBREFA), which amended 

the Regulatory Flexibility Act (RFA). 

Since regulation of PV29 under TSCA 

was expected to have a significant 

economic impact on a substantial 

number of small entities, also referred to 

as SISNOSE, EPA convened a Small 

Business Advocacy Review (SBAR) 

Panel to ensure future regulation of 

PV29 would have minimal impact on 

small businesses’ operation while 

maximizing protection of human health. 

Small businesses selected for the panel, 

referred to as Small Entity 

Representatives (SERs), provided 

comments to the Agency to describe 

how a PV29 regulation would impact 

their operations, including their use of 

PV29, current protections taken when 

using PV29 in their facilities, and how 

possible regulatory options the Agency 

could take would impact their 

operations. 

Comments from multiple (ink, 

disposal, paint, and manufacturing) 

SERs during the SBAR Panel indicated 

that, in their experience, once a pigment 

is incorporated into a matrix, it no 

longer retains its original properties. For 

example, the statement from SERs 

would imply that dry powder PV29 

would not have the same toxicological 

profile as PV29 mixed into paint, 

similar to the Proposition 65 warning 

position from California’s EPA for 

titanium dioxide, which includes 

‘‘airborne, unbound particles of 

respirable size’’ and states that the 

warning does not cover titanium 

dioxide when it remains bound within 

a product matrix (Ref. 3). One 

commenter cited the Proposition 65 

warnings for Carbon Black in California, 

where the risk to human health for the 

pigment is limited to ‘‘airborne, 

unbound particles of respirable size.’’ 

EPA’s interpretation of the comment 

and the Proposition 65 warning is that 

after the pigment is mixed into solution, 

there are no further human health 

inhalation risks of concern (Refs. 3, 4). 

Information provided by SERs and 

their representatives during the SBAR 

panel process indicates encapsulating 

PV29 into pigment for a paint requires 

dispersants and a dispersion medium to 

be mixed with pigment, and once PV29 

is incorporated into paint, it does not 

retain its dry particle properties. In 

addition, in a memo written by the 

Agency to clarify assertions made in the 

2021 Risk Evaluation, once PV29 is 

encapsulated into plastics, paints, and 

inks, it is not expected to be reactive or 

leachable, and thus would not be 

biologically available (Ref. 5). For the 

purpose of risk management, EPA has 

interpreted this statement to mean that 

encapsulated PV29 will not present the 

same human health hazards as dry 

powder PV29. This information was 

factored into the development of the 

proposed regulatory options for PV29. 

The Agency recognizes that strict 

workplace controls can be implemented 

to address unreasonable risk of PV29. 

For these reasons, this rule proposes to 

allow PV29’s continued use, with 

additional worker protection for the 

conditions of use where PV29 is used in 

a dry powder form. This proposed 

approach will address the unreasonable 

risk of injury to health presented by 

PV29 to the extent necessary so that the 

chemical no longer presents 

unreasonable risk. 

E. What are the estimated incremental 

impacts of this action? 

EPA’s Economic Analysis of the 

estimated incremental impacts 

associated with this rulemaking can be 

found in the rulemaking docket (Ref. 6). 

As described in more detail in the 

Economic Analysis (Ref. 6), EPA was 

unable to quantify all incremental costs 

of this proposed rule. EPA’s estimate of 

the costs of this proposed rule are 

estimated to range from $1.6 million to 

$1.7 million per year annualized over 

15-years at a 2% discount rate (Ref. 6). 

Cost estimates are described in this Unit 

and more fully in Section 4 of the 

Economic Analysis. The cost estimates 

for the proposed rule include costs of 

rule familiarization, labeling and 

downstream notification, PPE, and 

equipment cleaning. PPE cost estimates 

are estimated as incremental to baseline 

conditions and include the costs of the 

equipment itself, as well as the costs of 

a medical evaluation, fit testing, and 

equipment cleaning that ensure proper 

use and maintenance of the PPE. There 

may be some unquantified costs 

associated with respirator use and 

estimates of numbers of facilities 

importing or using regulated PV29. The 

extent to which respirators might reduce 

worker productivity or necessitate 

offering higher wages to workers who 

must wear respirators is unknown and 

therefore unquantified in the Economic 

Analysis. 

Unit IV. details which actions apply 

to which conditions of use. EPA 

estimates that 22 firms associated with 

22 sites may be manufacturing 

(including importing), processing, or 

using regulated (i.e., dry powder) PV29. 

A single domestic firm is manufacturing 

and selling regulated PV29 and EPA has 

identified a single importer of regulated 

PV29, and assumes the importer uses 

the PV29 and does not resell PV29. 

Twenty firms are estimated to use but 

not resell regulated PV29. Therefore, 

EPA estimates that only one firm would 

be subject to the requirement to label 

products and provide downstream 

notification. Additionally, EPA 

estimates that approximately 50,000 

firms undertake activities that fall under 

conditions of use subject to 

requirements but do not manufacture 

(including import), process, or use 

regulated PV29 when performing those 

activities. While these firms are not 

estimated to be subject to the proposed 

requirements because they are not 

expected to use dry powder PV29, they 

should read the proposal in order to 

make that determination. Information 

on the development of estimates of 


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3110 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Proposed Rules 

affected facilities can be found in 

Section 3 of the Economic Analysis. 

EPA estimates that approximately five 

small entities using regulated PV29 

would be subject to the requirements of 

the proposed rule. Additionally, EPA 

estimates that approximately 50,000 

small businesses that may be involved 

in activities in affected conditions of use 

do not use regulated PV29 but would, 

nevertheless, need to familiarize 

themselves with the rule to determine 

whether there is a need to comply with 

specific requirements. EPA found 

impacts under 1% of annual revenues 

for all but one of the small entities. 

Chronic exposure to dry powder C.I. 

Pigment Violet 29 may increase lung 

burden which may result in kinetic lung 

overload, a pharmacokinetic 

phenomenon, which is not due to the 

overt toxicity of the chemical, but rather 

the possibility that C.I. Pigment Violet 

29 dust overwhelms the lung clearance 

mechanisms over time. The inhalation 

toxicity data on the analogue carbon 

black demonstrated increased lung 

burden, alveolar hyperplasia, and 

inflammatory and morphological 

changes in the lower respiratory tract. 

These endpoints are not monetizable 

themselves, however there are 

occupational studies on carbon black 

that have found significant relationships 

between inhalable carbon black dust 

exposure and respiratory effects, 

including chronic bronchitis. Therefore, 

EPA’s Economic Analysis provides 

estimates to understand the magnitude 

of potential chronic bronchitis cases 

avoided from exposure reduction to 

PV29 as a result of the proposed rule. 

The estimated monetized benefit of the 

proposed regulatory action ranges from 

approximately $271,000 to $629,000 per 

year annualized over 15-years at a 2% 

discount rate. 

II. Background 

A. Overview of C.I. Pigment Violet 29 

PV29 is a perylene pigment that is 

reddish-purple in color and is currently 

manufactured as a powder, slurry, or 

paste. It is used to dye products, such 

as plastics and paints, and is commonly 

used in automobile paints and coatings. 

Though PV29 was first produced in 

1913, its commercialization did not 

occur until the late 1950s (Ref. 1). It has 

been recognized for its high color 

strength, weather fastness and heat 

stability. The reasons for these highperformance characteristics have been 

attributed to the organizational structure 

of the molecule (Ref. 1). 

EPA has identified alveolar 

hyperplasia (increased number of cells 

in the lungs where oxygen transfer 

occurs), inflammatory and 

morphological changes in the lungs 

from chronic inhalation exposure to 

PV29 in the workplace as the basis for 

the unreasonable risk for PV29 (Ref. 1). 

This proposed rule is specifically 

intended to address the unreasonable 

risk of injury to health that EPA has 

identified in the 2021 Risk Evaluation 

for PV29 and the September 2022 

revised unreasonable risk 

determination, as described in Unit 

III.B. 

According to data collected in EPA’s 

2016 Chemical Data Reporting (CDR) 

Rule, approximately 603,500 lbs. 

(exclusive of imports) were 

manufactured in the United States in 

Reporting Year 2015 (Refs. 1, 6). EPA 

assumes that regulated PV29 is expected 

to be imported at unknown minor 

volumes under 25,000 lbs (Ref. 6). The 

exact production volume, including 

domestic manufacture and import, in 

the 2020 CDR was reported as 

confidential business information (CBI) 

but is estimated to be less than 

1,000,000 lbs. PV29’s use as a pigment 

in the colorant industry is described in 

Unit III.B.1., with a description of 

proposed requirements to address the 

unreasonable risk in Units III.B.3, and 

IV.A. 

B. Regulatory Actions Pertaining to C.I. 

Pigment Violet 29 

PV29 is on multiple countries’ 

chemical inventories but is not subject 

to chemical-specific statutory or 

regulatory restrictions in other countries 

and/or international treaties and/or 

agreements. In the United States, PV29 

is regulated under the OSH Act as a 

Particulate Not Otherwise Regulated 

(PNOR) and is subject to OSHA’s 

respirable dust requirements (29 CFR 

1910.1000 Table Z–1), as there are no 

chemical specific requirements for PV29 

(https://www.osha.gov/chemicaldata/ 

801). PNOR substances include dust, 

nuisance dust, and inert dust; they are 

described as ‘‘dusts from solid 

substances’’ without reference to a 

specific CASRN (https://www.osha.gov/ 

chemicaldata/801). Additionally, under 

the Federal Food, Drug, and Cosmetics 

Act, PV29 is approved for use as a 

colorant for polymers in food-related 

articles, such as food packaging, at or 

below 1 percent by weight of polymers 

and should follow specific conditions of 

use (21 CFR 178.3297). PV29 is not 

listed as an approved food additive (Ref. 

1). PV29 is subject to CDR reporting 

requirements under TSCA. 

EPA did not identify information 

indicating that PV29 is subject to 

chemical-specific restrictions under 

state statutes or regulations 

implemented by state agencies or 

departments. A summary of the 

regulatory actions pertaining to PV29 

can be found in Appendix A.1 of the 

2021 PV29 Risk Evaluation (Ref. 1). 

C. Summary of EPA’s Risk Evaluation 

Activities on PV29 

EPA published the scope of the PV29 

risk evaluation (82 FR 6545, January 19, 

2017 (FRL–9958–33)), and, after 

receiving public comments, published 

the problem formulation in June 2018 

(83 FR 26998, June 11, 2018 (FRL–9978– 

40)). In November 2018, EPA published 

a draft risk evaluation (83 FR 57473, 

November 15, 2018 (FRL–9986–45)), a 

revised draft risk evaluation in October 

2020 (85 FR 68873, October 30, 2020 

(FRL–10015–96)), and after public 

comment and peer review by the 

Science Advisory Committee on 

Chemicals (SACC), EPA issued the Final 

Risk Evaluation for C.I. Pigment Violet 

29 in January 2021 in accordance with 

TSCA section 6(b) (86 FR 6322, January 

21, 2021 (FRL–10017–50)). EPA 

subsequently issued a draft Revised 

Unreasonable Risk Determination for 

PV29 (87 FR 12690, March 7, 2022 

(FRL–9403–01–OCSPP)), and after 

public notice and receipt of comments, 

published the Final Revised 

Unreasonable Risk Determination for C.I 

Pigment Violet 29 in September 2022 

(87 FR 54491, September 6, 2022 (FRL– 

9403–02–OCSPP)). The 2021 Risk 

Evaluation for C.I. Pigment Violet 29 

and supplemental materials are in 

docket EPA–HQ–OPPT–2018–0604, 

with the September 2022 revised 

unreasonable risk determination and 

additional materials supporting the risk 

evaluation process in docket EPA–HQ– 

OPPT–2016–0725, on https://

www.regulations.gov. 

1. 2021 Risk Evaluation 

In the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, EPA evaluated risks 

associated with 14 conditions of use 

within the following life cycle stages: 

manufacture (including import), 

processing, distribution in commerce, 

industrial and commercial use, 

consumer use, and disposal (Ref. 1). 

Descriptions of the conditions of use 

that contribute to the unreasonable risk 

are in Unit III.B.1. The 2021 Risk 

Evaluation for C.I. Pigment Violet 29 

identified significant adverse human 

health effects associated with long-term 

exposure to PV29, specifically alveolar 

hyperplasia, inflammatory and 

morphological changes in the lungs 

from chronic inhalation exposures. A 

further discussion of the unreasonable 

risk of PV29 is in Unit III.B.3. 


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2. 2022 Revised Unreasonable Risk 

Determination 

EPA revisited specific aspects of its 

first 10 TSCA existing chemical risk 

evaluations, including the PV29 risk 

evaluation, to ensure that the risk 

evaluations upon which risk 

management decisions are made were 

better aligned with TSCA’s objective of 

protecting health and the environment. 

For PV29, EPA revised the original 

unreasonable risk determination based 

on the 2021 Risk Evaluation and issued 

a final revised unreasonable risk 

determination in September 2022 (Ref. 

2). EPA revised the risk determination 

for the 2021 Risk Evaluation for C.I. 

Pigment Violet 29 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 Biden-Harris 

Administration priorities (Refs. 7, 8, 9). 

The revisions consisted of making a 

single risk determination for the 

chemical substance instead of by 

individual conditions of use (which 

resulted in the revised risk 

determination superseding the prior ‘‘no 

unreasonable risk’’ determinations and 

the withdrawal of the associated TSCA 

section 6(i)(1) ‘‘no unreasonable risk’’ 

orders); and revising the risk 

determination to no longer reflect an 

assumption that all workers are always 

provided and appropriately wear PPE 

(Ref. 2). 

In determining whether PV29 

presents unreasonable risk under the 

conditions of use, EPA considered 

relevant risk-related factors, including, 

but not limited to: the effects of the 

chemical substance on health (including 

non-cancer risks) and human exposure 

to the substance under the conditions of 

use (including duration, magnitude and 

frequency of exposure); the effects of the 

chemical substance on the environment 

and environmental exposure under the 

conditions of use; the population 

exposed (including any potentially 

exposed or susceptible subpopulations); 

the severity of hazard (including the 

nature of the hazard, the irreversibility 

of the hazard); and uncertainties. 

EPA determined that PV29 presents 

an unreasonable risk of injury to human 

health. Inhalation exposure under 10 

conditions of use contribute to the 

unreasonable risk of injury to health for 

workers and occupational non-users 

(ONUs, or workers who do not directly 

handle PV29 but perform work in an 

area where PV29 is present) from 

occupational exposures (i.e., during 

manufacture, processing, industrial and 

commercial uses, disposal). EPA did not 

identify risks of injury to the 

environment that contribute to the 

unreasonable risk for PV29. The PV29 

conditions of use that contribute to 

EPA’s determination that the chemical 

substance poses unreasonable risk of 

injury to health are listed in the 

unreasonable risk determination (Ref. 2) 

and in Unit III.B.1., with descriptions to 

aid chemical manufacturers, processors, 

and users in determining how their 

particular use or activity would be 

addressed under the proposed 

regulatory provisions. 

3. Additional Information Received 

During Risk Management 

Following the publication of the 2021 

Risk Evaluation for C.I. Pigment Violet 

29, the Agency received information 

from stakeholders during the public 

comment period after publication of the 

draft revised risk determination, the 

SBAR process, and through additional 

meetings with stakeholders (Ref. 10, 3, 

11). This information was considered as 

part of the development of the proposed 

and primary alternative regulatory 

actions and was used to further identify 

where occupational worker and ONU 

exposure to dry powder PV29 occurs. 

As part of this rulemaking, EPA 

would like to clarify that the 

unreasonable risk is due to inhalation 

exposure to dry powder PV29 and not 

to PV29 already incorporated into a 

liquid mixture, such as wet paint or ink. 

This clarification is needed in part due 

to a more robust understanding of the 

PV29 downstream uses through 

information provided by small entity 

representatives and through EPA 

analysis as noted in EPA’s 

memorandum described in this 

document (Ref. 5) and further 

consideration of the listing of carbon 

black under Proposition 65 in California 

(Ref. 4). In the response to comments for 

the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, EPA stated that the 

risk of injury to health was present for 

PV29 in its dry powder form and when 

in solution or a mixture, such as wet or 

dry paint (Ref. 12). This included 

potential risk of injury to health from 

inhalation exposure to paint containing 

PV29 during automotive spray painting, 

sanding, grinding, and repair service 

activities (Ref. 12). This assertion was 

repeated in the response to comments 

for the 2022 Draft Revised Unreasonable 

Risk Determination in reference to 

automotive paint, where the Agency 

explained its belief that other 

automotive spray painting, sanding, 

grinding, and repair services expose 

workers and ONUs to PV29 aerosolized 

particles due to disturbance of 

previously painted surfaces through 

airborne distribution and that these 

exposures are drivers of the 

unreasonable risk presented by PV29 

(Ref. 10, p. 28). 

In the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, EPA stated that PV29 

present in dried paint and plastic 

products is expected to be encapsulated 

and available physical and chemical 

property information indicates that due 

to a low solubility in water and octanol, 

it is not expected to leach out (Ref. 1, 

p. 59). EPA also stated in the TSCA risk 

evaluation for PV29 that PV29 is not 

expected to be reactive or leachable 

either as a neat material or encapsulated 

in plastics or paint resins (Ref. 1, p. 65). 

The statements in the risk evaluation 

support the conclusion that, pigments 

with a dry powder form like PV29, 

including carbon black, do not present 

the same inhalation exposure risk after 

they are mixed into solution and 

encapsulated such that PV29 particles 

cannot be released. Carbon black was 

the analogue used for PV29’s toxicity in 

the 2021 PV29 risk evaluation. 

Commenters during the SBAR Panel 

meeting specifically mentioned the 

Proposition 65 regulation in California, 

where carbon black is listed as a 

carcinogen specifically for airborne, 

unbound particles of respirable size 

(Ref. 3, 4). Similar to the statements 

about encapsulation of PV29 in the 

TSCA risk evaluation, the Carbon Black 

Proposition 65 Listing Notice stated that 

exposure to carbon black, per se, does 

not occur when it remains bound within 

a product matrix, such as rubber, ink or 

paint (Ref. 4). 

EPA has issued a memo (Ref. 5), in 

which the Agency provides clarity about 

exposure-related statements made since 

the publication of the risk evaluation. 

This memo states that the risk assessed 

in the 2021 Risk Evaluation for C.I. 

Pigment Violet 29 is based on the 

analogue carbon black and is associated 

with inhalation exposures of PV29 in 

manufacturing and processing as 

particles in the dry powder form. 

Exposure to paint aerosols containing 

PV29 was not assessed in the risk 

evaluation. The conclusions of the 

memo are supported by the following 

sections of the risk evaluation which 

note that PV29 encapsulated in plastics, 

paints, and inks are not expected to be 

reactive or leachable, and therefore, not 

likely to be biologically available when 

not in dry powder form: 

• Section 1.1 addresses the physicalchemical properties of PV29 and states 

that the chemical is extremely insoluble 

in water or other organic solvents and 

has a very low vapor pressure. 

• Section 1.4.1.3 cites information 

provided by a stakeholder about the 


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encapsulation of PV29 in plastic resins 

due to its low solubility in water and 

octanol. 

• Section 1.4.1.4 states that inhalation 

is not identified as a route of exposure 

for commercially available watercolor or 

acrylic paints due to low vapor pressure 

of PV29. 

• Section 2.3.2 states that inhalation 

is not an expected route of exposure for 

commercially available watercolor and 

acrylic paints and that dermal and oral 

absorption is expected to be limited 

from the same source due to low water 

solubility. 

Taken together, the information and 

statements in the memo clarify that EPA 

agrees when PV29 is incorporated into 

the matrix of paint and other liquid 

media, such as ink, it does not retain the 

original dry particle properties of its 

original form. This information applies 

to automotive spray painting, sanding, 

grinding and repair services, since they 

involve use of dried paint containing 

PV29. In these instances, PV29 has been 

used within a mixture and is no longer 

bioavailable in its dry powder form. 

EPA is requesting comment on the 

interpretations of risk when it is in other 

forms including bound in a matrix like 

paint or liquid, and if uses, e.g. aerosol 

spraying, sanding or grinding dry paint, 

could render PV29 biologically available 

or possibly pose an inhalation exposure 

risk. 

III. Regulatory Approach 

A. Background 

Under TSCA section 6(a), if the 

Administrator determines through a 

TSCA section 6(b) risk evaluation that 

the manufacture (including import), 

processing, distribution in commerce, 

use, or disposal of a chemical substance 

or mixture, or any combination of such 

activities, presents an unreasonable risk 

of injury to health or the environment, 

EPA must by rule apply one or more of 

the following requirements to the extent 

necessary so that the chemical 

substance or mixture no longer presents 

such risk. 

• Prohibit or otherwise restrict the 

manufacturing (including import), 

processing, or distribution in commerce 

of the substance or mixture, or limit the 

amount of such substance or mixture 

which may be manufactured, processed, 

or distributed in commerce (TSCA 

section 6(a)(1)). 

• Prohibit or otherwise restrict the 

manufacturing, processing, or 

distribution in commerce of the 

substance or mixture for a particular use 

or above a specific concentration for a 

particular use (TSCA section 6(a)(2)). 

• Limit the amount of the substance 

or mixture which may be manufactured, 

processed, or distributed in commerce 

for a particular use or above a specific 

concentration for a particular use 

specified (TSCA section 6(a)(2)). 

• Require clear and adequate 

minimum warnings and instructions 

with respect to the substance or 

mixture’s use, distribution in commerce, 

or disposal, or any combination of those 

activities, to be marked on or 

accompanying the substance or mixture 

(TSCA section 6(a)(3)). 

• Require manufacturers and 

processors of the substance or mixture 

to make and retain certain records, or 

conduct certain monitoring or testing 

(TSCA section 6(a)(4)). 

• Prohibit or otherwise regulate any 

manner or method of commercial use of 

the substance or mixture (TSCA section 

6(a)(5)). 

• Prohibit or otherwise regulate any 

manner or method of disposal of the 

substance or mixture, or any article 

containing such substance or mixture, 

by its manufacturer or processor or by 

any person who uses or disposes of it 

for commercial purposes (TSCA section 

6(a)(6)). 

• Direct manufacturers or processors 

of the substance or mixture to give 

notice of the unreasonable risk 

determination to distributors, certain 

other persons, and the public, and to 

replace or repurchase the substance or 

mixture (TSCA section 6(a)(7)). 

As described in Unit III.B., EPA 

assessed how the TSCA section 6(a) 

requirements could be applied to 

address the unreasonable risk identified 

in the 2021 Risk Evaluation for C.I. 

Pigment Violet 29 and the final revised 

unreasonable risk determination, so that 

PV29 no longer presents such 

unreasonable risk. EPA’s proposed 

regulatory action and a primary 

alternative regulatory action are 

described in Unit IV. EPA is requesting 

public comment on all elements of the 

proposed regulatory action and the 

primary alternative regulatory action 

and is providing notice that, based on 

consideration of comments and any new 

information submitted to EPA during 

the comment period on this proposed 

rule, EPA may in the final rule modify 

elements of the proposed regulatory 

action. The public should understand 

that the Agency’s consideration of 

public comments could result in 

changes to elements of the proposed and 

alternative regulatory actions when this 

rule is finalized. For example, elements 

such as timelines for implementation 

could be lengthened or shortened, 

downstream notification could have 

requirements added or eliminated, or 

elements of the primary alternative 

regulatory action could be incorporated. 

Under the authority of TSCA section 

6(g), EPA may consider granting a timelimited exemption from a requirement 

of a TSCA section 6(a) rule for a specific 

condition of use if EPA finds that: (1) 

The specific condition of use is a critical 

or essential use for which no technically 

and economically feasible, safer 

alternative is available, taking into 

consideration hazard and exposure; (2) 

compliance with the requirement, as 

applied with respect to the specific 

condition of use, would significantly 

disrupt the national economy, national 

security, or critical infrastructure; or (3) 

the specific condition of use of the 

chemical substance, as compared to 

reasonably available alternatives, 

provides a substantial benefit to health, 

the environment, or public safety. Based 

on reasonably available information, 

EPA has analyzed the need for an 

exemption and is not proposing to grant 

an exemption from the rule 

requirements at this time. EPA is 

requesting public comment regarding 

the need for exemptions from the rule 

(and under what specific circumstances) 

pursuant to the provisions of TSCA 

section 6(g). EPA is also requesting 

comment on, in lieu of proposing a 6(g) 

exemption in a separate regulatory 

action, whether any elements of the 

primary alternative regulatory action 

should be considered in combination 

with elements of the proposed 

regulatory action as EPA develops the 

final regulatory action. 

TSCA section 6(c)(2)(C) requires that, 

in deciding whether to prohibit or 

restrict in a manner that substantially 

prevents a specific condition of use and 

in setting an appropriate transition 

period for such action, EPA consider, to 

the extent practicable, whether 

technically and economically feasible 

alternatives that benefit health or the 

environment will be reasonably 

available as a substitute when the 

proposed prohibition or restriction takes 

effect. As neither the proposed 

regulatory action nor the primary 

alternative regulation action would 

prohibit or restrict in a manner that 

substantially prevents activities for any 

conditions of use of PV29, an 

alternatives assessment was not 

conducted. 

Section 6(c)(2)(A) of TSCA requires 

EPA, in proposing and promulgating 

TSCA section 6(a) rules, to consider and 

include a statement of effects addressing 

certain factors such as the effects of the 

chemical substance on health or the 

environment and the magnitude of 

exposure, the benefits of the chemical, 

and the economic consequences of the 


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rule, including the cost and benefits and 

the cost effectiveness of the proposed 

regulatory action and of the one or more 

primary alternative regulatory actions 

considered. TSCA section 6(c)(2) 

considerations are discussed in Unit VI. 

EPA’s proposed regulatory action and a 

primary alternative regulatory action are 

fully discussed in Unit IV. EPA is 

requesting public comment on the 

proposed regulatory action and the 

alternative regulatory action. 

EPA carried out required 

consultations as described in this unit 

and also considered impacts on 

children’s environmental health as part 

of its approach to developing this TSCA 

section 6 regulatory action. 

1. Consultations 

EPA conducted consultations and 

outreach as part of development of this 

proposed regulatory action. The Agency 

held a federalism consultation on May 

13, 2021, as part of this rulemaking 

process and pursuant to Executive 

Order 13132. During the consultation, 

EPA met with State and local officials 

early in the process of developing the 

proposed action in order to receive 

meaningful and timely input into its 

development (Ref. 13). During the 

consultation, participants and EPA 

discussed preemption, EPA’s authority 

under TSCA section 6 to regulate 

identified unreasonable risk, what 

activities would be potentially regulated 

in the proposed rule, and the 

relationship between TSCA and existing 

statutes (Ref. 13). EPA received no 

written comments as part of this 

consultation. 

PV29 is not manufactured (including 

imported), processed, distributed in 

commerce, or regulated by tribes. 

However, EPA consulted with tribal 

officials during the development of this 

proposed action. The Agency held a 

Tribal consultation on May 24 and June 

3, 2021. Tribal officials were given the 

opportunity to meaningfully interact 

with EPA risk managers concerning the 

current status of risk management. 

During the consultation, EPA discussed 

risk management under TSCA section 

6(a), findings from the 2021 Risk 

Evaluation for C.I. Pigment Violet 29, 

types of information that would be 

helpful to inform risk management, 

principles for transparency during the 

risk management process, and types of 

information EPA is seeking from tribes 

(Ref. 14). EPA received no written 

comments as part of this consultation. 

In addition to the formal 

consultations, EPA also conducted 

outreach to advocates for communities 

that might be subject to disproportionate 

exposure to PV29, such as minority 

populations, low-income populations, 

and indigenous peoples. EPA’s 

Environmental Justice (EJ) consultation 

occurred on June 1 and 9, 2021. EPA 

held public meetings as part of this 

consultation which were held pursuant 

to and in compliance with Executive 

Orders 12898 and 14008 (Ref. 15). EPA 

received no written comments following 

the EJ meeting. 

EPA convened a SBAR Panel to obtain 

advice and recommendations from SERs 

that potentially would be subject to this 

proposed rule’s requirements (Ref. 3). 

EPA met with SERs before and during 

Panel proceedings, on January 25, 2022, 

and September 14, 2023. Panel 

recommendations are in Unit V.A.5.; the 

Panel report is in the docket (Ref. 3). 

Additional requests for comment based 

on Panel recommendations are in Unit 

VIII. 

Units X.C., X.E., X.F. and X.J. provide 

more information regarding the 

consultations. 

2. Other Stakeholder Consultations 

In addition to the formal 

consultations described in Unit X., EPA 

held a public webinar on February 23, 

2021, and attended a Small Business 

Administration (SBA) Roundtable on 

February 26, 2021. At both events EPA 

staff provided an overview of the TSCA 

risk management process and the 

findings in the 2021 Risk Evaluation for 

C.I. Pigment Violet 29 (Refs. 16, 17). 

Attendees of these meetings were given 

an opportunity to voice their concerns 

on both the risk evaluation and risk 

management. 

Furthermore, EPA has engaged in 

discussions with representatives from 

different industries, technical experts, 

and users of PV29. A list of external 

meetings held during the development 

of this proposed rule is in the docket 

(Ref. 11); meeting materials and 

summaries are also in the docket. The 

purpose of these discussions was to hear 

from importers, processors, distributors, 

and users about the conditions of use 

evaluated for PV29; substitute chemicals 

or alternative methods; engineering 

control measures and personal 

protective equipment currently in use or 

potentially feasible for adoption; and 

other risk reduction approaches that 

may have already been adopted or 

considered for the evaluated conditions 

of use. 

3. Children’s Environmental Health 

The Agency’s 2021 Policy on 

Children’s Health (Ref. 18) articulates 

EPA’s policy of protecting children from 

environmental exposures by 

consistently and explicitly considering 

early life exposures (from conception, 

infancy, early childhood and through 

adolescence until 21 years of age) and 

lifelong health in all human health 

decisions through identifying and 

integrating children’s health data and 

information when conducting risk 

assessments. TSCA section 6(b)(4)(A) 

also requires EPA to conduct risk 

evaluations to determine whether a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, 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. Infants, children, 

and pregnant women are listed as 

examples of subpopulations that may be 

considered relevant ‘‘potentially 

exposed or susceptible subpopulations’’ 

in the TSCA section 3(12) definition of 

that term. In addition, TSCA section 6(a) 

requires EPA to apply one or more risk 

management requirements under TSCA 

section 6(a) so that PV29 no longer 

presents an unreasonable risk (including 

unreasonable risk to potentially exposed 

or susceptible subpopulations). 

The Risk Evaluation for C.I. Pigment 

Violet 29 released in January 2021 

considered impacts on both children 

and adults from occupational use from 

inhalation and dermal exposures, as 

applicable. The risk evaluation 

considered males (>16 years of age) and 

females of reproductive age (>16 years 

of age) for inhalation exposure. While 

risks to children are not 

disproportionate, effects observed in 

studies include alveolar hyperplasia, 

inflammatory, and morphological 

changes in the lungs from chronic 

inhalation exposure. The effects related 

to the endpoint used for PV29 risk 

evaluation were alveolar hyperplasia, 

inflammatory, and morphological 

changes in the lungs, which are not 

associated with disproportionate effects 

to children. The risks identified in this 

section would be addressed by both the 

proposed regulatory action and primary 

alternative action described in Unit IV. 

B. Regulatory Assessment of C.I. 

Pigment Violet 29 

1. Description of Conditions of Use That 

Contribute to the Unreasonable Risk 

This unit describes the TSCA 

conditions of use that contribute to 

EPA’s unreasonable risk determination 

for the chemical substance PV29. 

Condition of use descriptions were 

obtained from EPA sources such as the 

2021 Risk Evaluation for C.I. Pigment 

Violet 29 and related documents, and 

include clarifications based on the CDR 

use codes, as well as the Organisation 


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for Economic Co-operation and 

Development (OECD) harmonized use 

codes and feedback from stakeholders 

regarding how they describe their uses. 

For additional description of the 

conditions of use, including process 

descriptions and worker activities 

considered in the risk evaluation, see 

the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, and supplemental 

files (Refs. 1, 19). EPA acknowledges 

that some of the terms used in this unit 

may also be defined under other 

statutes; however, the descriptions in 

this unit are intended to provide clarity 

to the regulated entities subject to the 

provisions of this rule under TSCA 

section 6(a). 

a. Manufacturing 

i. Domestic Manufacture 

Domestic manufacturing means to 

manufacture or produce PV29 within 

the United States. For purposes of PV29 

risk management, this includes the 

complex combination of chemical 

substances to form PV29 and loading 

and repackaging (but not transport) 

associated with the manufacturing and 

production of PV29. 

Based on the reasonably available 

information before the Agency, EPA 

believes PV29 is currently manufactured 

within the United States by one 

company. EPA received information 

regarding the bagging and pack out 

process at the end of manufacturing 

(Ref. 3). The chemical reaction for PV29 

production is well-established, PV29 is 

obtained by reacting naphthalimide 

(CASRN 81–83–4) with molten 

potassium hydroxide, causing the 

potassium salt of the leuco form of 

perylenetetracarboxylic diimide to be 

formed, and followed by atmosphere 

oxidation (Ref. 1). 

This domestic manufacturer of PV29 

reports that it produces PV29 as a 

powder that is used within its own 

plant to produce other pigments or is 

sold to other manufacturers and 

processers in bags (Ref. 1). In addition, 

powder PV29 can be sold to other 

manufacturers in a pelleted or slurry 

form in addition to powder form (Ref. 

3). Approximately 80% of PV29 

produced in the U.S. is used to make 

other pigments and the remaining 20% 

produced is shipped out of the facility 

to customers or exported (Ref. 3). The 

paint and coatings trade organization 

which represents PV29’s current 

domestic manufacturer stated that PV29 

powder is produced 12 times a year over 

the course of one 12-hour shift by 2 

workers (Ref. 3). 

ii. Import 

Import refers to the import of PV29 

into the customs territory of the United 

States and loading and repackaging (but 

not transport) associated with the 

import of PV29. In general, chemicals 

may be imported into the United States 

in bulk via water, air, land, and 

intermodal shipments. These shipments 

take the form of oceangoing chemical 

tankers, railcars, tank trucks, and 

intermodal tank containers. PV29 can be 

imported as a powder and liquid, 

including as a tint paste (Ref. 1). EPA 

expects that PV29 and products 

containing PV29 are often stored in 

warehouses prior to distribution for 

further processing and use. Only one 

company has been identified as an 

importer of PV29 (Ref. 1). This company 

reported to EPA’s Chemical Data Rule 

(CDR) that it imports PV29 as a ‘‘liquid, 

other solid,’’ which, based on the 

Agency’s knowledge of forms of PV29, 

is likely a paste (Ref. 6). Additionally, 

information provided to EPA by the 

company also suggests that they import 

both a tint paste and dry powder form 

PV29 in volumes less than 25,000 lbs./ 

yr. (Ref. 19). It is possible that there are 

other companies importing volumes at 

less than 25,000 lbs/yr that EPA is not 

able to identify. 

b. Processing 

i. Processing: Incorporation Into 

Formulation, Mixture, or Reaction 

Products in Paints and Coatings 

This condition of use (COU) refers to 

the preparation of a product, i.e., the 

incorporation of dry powder PV29 into 

formulation, mixture, or a reaction 

product which occurs when a chemical 

substance is added to a product (or 

product mixture), after its manufacture, 

for distribution in commerce. In this 

case, ‘‘processing’’ refers to the mixing 

of dry powder PV29 into paints and 

coatings. Processors of PV29 for paint 

and coating manufacturing receive the 

chemical at 80% concentration in 

powder in bags that are manually 

opened and dumped into a mixer where 

it is milled and formulated into a tint 

paste. The paste is added to a wide 

variety of liquid base coats for the 

automobile industry (Ref. 20). EPA 

estimates that 14 facilities would 

process dry powder PV29 into paints 

and coatings (Ref. 6). 

ii. Processing: Incorporation Into 

Formulation, Mixture, or Reaction 

Products in Plastic and Rubber Products 

This COU refers to the preparation of 

a product, i.e., the incorporation of dry 

powder PV29 into formulation, mixture, 

or a reaction product which occurs 

when a chemical substance is added to 

a product (or product mixture), after its 

manufacture, for distribution in 

commerce. In this case, ‘‘processing’’ 

refers to the mixing of dry powder PV29 

into plastic and rubber products. A 

processor of PV29 for plastic 

manufacturing receives the chemical in 

bags that are manually opened and 

added to a vessel for weighing and dry 

blending with polymers and other 

additives. This preparation is then 

extruded via a continuous and closed 

process involving encapsulation into 

pellets (Ref. 20). EPA estimates that six 

facilities process dry powder PV29 into 

plastics (Ref. 6). 

iii. Processing: Intermediate in the 

Creation or Adjustment of Color of 

Other Perylene Pigments 

This COU refers to the use of the dry 

powder PV29 in a chemical reaction for 

the manufacturing of another chemical 

substance or product. In this case, 

‘‘processing’’ refers to the use of dry 

powder PV29 in the manufacturing of 

perylene pigment. According to 

information provided to EPA by the 

manufacturer of PV29, the production of 

PV29 is the starting point for the 

synthesis of all other perylene pigments 

at the manufacturing facility and other 

perylenes produced at the 

manufacturing facility may contain an 

estimated 0–5% residual C.I. Pigment 

Violet 29 in the finished pigment. (Ref. 

19). 

iv. Processing: Recycling 

This COU refers to the process of 

treating generated waste streams (i.e., 

which would otherwise be disposed of 

as waste) containing PV29 that are 

collected, either on-site or transported 

to a third-party site, for commercial 

purpose. PV29 is primarily recycled 

commercially in the form of PV29- 

containing articles, including plastics 

and auto parts. EPA did not find PV29- 

specific information for recycling, 

including specific worker activities and 

commonly recycled materials (Ref 1). 

c. Industrial and Commercial Use 

i. Industrial and Commercial Use in 

Automobile Paints and Coatings 

(Original Equipment Manufacturing and 

Refinishing) 

This COU refers to the industrial and 

commercial use of industrial or 

commercial automobile paints and 

coating products, including primers, 

topcoats, and basecoats containing 

PV29. Activities where these types of 

automobile paint and coatings products 

are used could include mixing and 

spray applications, including use of a 

spray gun, after the original 


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manufacturing process for automobiles 

and as part of refinishing operations. 

These products could also be sanded 

after curing during automotive 

refinishing operations (Ref. 1). 

ii. Industrial and Commercial Use in 

Coatings and Basecoats for Paints and 

Coatings 

This COU refers to the industrial and 

commercial use of industrial or 

commercial coating and basecoat 

products that are not specifically used 

as part of automobile manufacturing and 

refinishing operations. PV29 could be 

present in pigment dispersions in 

waterborne and solventborne systems, 

waterborne and solventborne basecoats, 

and as a colorant in solventborne 

coating (Ref. 21). 

iii. Industrial and Commercial Use in 

Merchant Ink for Commercial Printing 

This COU refers to the industrial and 

commercial use of industrial or 

commercial printing ink. Public 

comments during the risk evaluation 

state PV29 could be used in inkjet ink 

(Ref. 1). It is estimated that about 1% of 

PV29 produced within the domestic 

market is used in merchant ink for 

commercial printing and packaging, 

especially where lightfastness and color 

stability are important (Ref. 22). 

In the risk evaluation, this COU 

included the use of PV29 in merchant 

ink; however, information provided 

since the publication of the risk 

evaluation indicates that PV29 use in 

merchant ink is uncommon (Ref. 3), and 

that PV29 is not used in any ink 

formulation for any of the following 

print processes in the graphics arts 

industry: screen, digital, offset 

lithographic, letterpress, rotogravure, or 

flexographic (Ref. 3). 

d. Disposal 

Each of the conditions of use of PV29 

may generate waste streams of the 

chemical. This COU refers to PV29 in a 

waste stream that is collected and 

transported to third-party sites for 

disposal or treatment. This COU also 

encompasses PV29 contained in 

wastewater discharged to publicly 

owned treatment works or other, nonpublic treatment works for treatment, 

and other wastes. Recycling of PV29 and 

PV29 containing products is considered 

a different COU. 

e. Terminology in This Proposed Rule 

For the purposes of this proposed 

rulemaking, ‘‘occupational conditions of 

use’’ refers to the TSCA conditions of 

use described in Units III.B.1.a. through 

d. Although EPA identified both 

industrial and commercial uses in the 

2021 Risk Evaluation for C.I. Pigment 

Violet 29 for purposes of distinguishing 

exposure scenarios, the Agency clarified 

then and clarifies now that EPA 

interprets the authority over ‘‘any 

manner or method of commercial use’’ 

under TSCA section 6(a)(5) to include 

both. In the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, EPA identified and 

assessed all known, intended, and 

reasonably foreseen uses of PV29. 

EPA is not proposing to incorporate 

the descriptions of known, intended or 

reasonably foreseen conditions of use of 

PV29 presented and described in Unit 

III.B.1.a. through d. as definitions in the 

regulatory text. However, EPA requests 

comment on whether EPA should 

promulgate definitions for those 

conditions of use evaluated in the 2021 

Risk Evaluation for C.I. Pigment Violet 

29, and, if so, whether the descriptions 

in this unit are consistent with the 

conditions of use evaluated in the 2021 

Risk Evaluation for C.I. Pigment Violet 

29 and whether they provide a sufficient 

level of detail to improve the clarity and 

readability of the regulation if EPA were 

to promulgate a regulation that contains 

a list of all regulated industrial and 

commercial conditions of use. 

EPA further notes that this proposed 

rule would not apply to any substance 

excluded from the definition of 

‘‘chemical substance’’ under TSCA 

section 3(2)(B)(ii) through (vi). Those 

exclusions include, but are not limited 

to, any pesticide (as defined by the 

Federal Insecticide, Fungicide, and 

Rodenticide Act) when manufactured, 

processed, or distributed in commerce 

for use as a pesticide; and any food, 

food additive, drug, cosmetic, or device, 

as defined in section 201 of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

when manufactured, processed, or 

distributed in commerce for use as a 

food, food additive, drug, cosmetic or 

device. 

2. Description of Unreasonable Risk 

Under the Conditions of Use 

EPA has determined that PV29 

presents an unreasonable risk of injury 

to human health under the conditions of 

use based on chronic toxicity for noncancer effects. As described in the 2021 

Risk Evaluation for C.I. Pigment Violet 

29, EPA identified lung toxicity adverse 

effects from chronic non-cancer 

inhalation exposures to PV29. Unit 

VI.A. summarizes the health effects and 

the magnitude of the exposures in more 

detail (Ref. 1). 

To make the unreasonable risk 

determination for PV29, EPA evaluated 

exposures to human receptors, 

including workers (which includes 

occupational non-users (ONUs)), using 

reasonably available monitoring and 

modeling data for inhalation exposures. 

EPA did not quantitatively evaluate 

risks to consumers or bystanders of 

consumer use because PV29 is not 

expected to volatilize from consumer 

paints due to its low vapor pressure 

(Ref. 1). 

For the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, EPA considered 

potentially exposed or susceptible 

subpopulations (PESS) identified as 

relevant to the risk evaluation by the 

Agency. Groups of individuals with 

greater exposure to PV29 relative to the 

general population include: (1) workers 

of either sex (>16 years old), including 

pregnant women, (2) individuals who 

do not use PV29 but may be indirectly 

exposed due to their proximity to the 

user who is directly handling PV29 

(ONUs), and (3) consumer users and 

bystanders associated with consumer 

use (Ref. 1). All PESS are included in 

the quantitative and qualitative analyses 

described in the 2021 Risk Evaluation 

for C.I. Pigment Violet 29 and were 

considered in the determination of 

unreasonable risk for PV29. The 2021 

Risk Evaluation for C.I. Pigment Violet 

29 did not quantitatively assess the air 

and water exposure pathways in the 

published risk evaluation due to PV29’s 

low vapor pressure, volatility, and 

solubility in water. 

3. Description of TSCA Section 6 

Requirements for Risk Management 

EPA considered the TSCA section 6(a) 

requirements (listed in Unit III.A.) to 

identify which ones have the potential 

to eliminate the unreasonable risk for 

PV29. 

As required, EPA developed a 

proposed regulatory action and one 

primary alternative regulatory action, 

which are described in Units IV.A. and 

IV.B., respectively. To identify and 

select a regulatory action, EPA 

considered the route of exposure driving 

the unreasonable risk, inhalation, and 

the exposed populations. For 

occupational conditions of use (see Unit 

III.B.1), EPA considered how it could 

directly regulate manufacturing 

(including import), processing, 

distribution in commerce, industrial 

and commercial use, or disposal to 

address the unreasonable risk. 

As required by TSCA section 6(c)(2), 

EPA considered several factors, in 

addition to identified unreasonable risk, 

when selecting among possible TSCA 

section 6(a) requirements. To the extent 

practicable, EPA factored into its 

decisions: (i) the effects of PV29 on 

health and the magnitude of exposure of 

human beings to PV29, (ii) the effects of 

PV29 on the environment and the 


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magnitude of exposure of the 

environment to PV29, (iii) the benefits 

of PV29 for various uses, and (iv) the 

reasonably ascertainable economic 

consequences of the rule. In evaluating 

the reasonably ascertainable economic 

consequences of the rule, EPA 

considered (i) the likely effect of the 

rule on the national economy, small 

business, technological innovation, the 

environment, and public health, (ii) the 

costs and benefits of the proposed 

regulatory action and of the primary 

alternative regulatory action considered, 

and (iii) the cost effectiveness of the 

proposed regulatory action and of the 

primary alternative regulatory action 

considered. See Unit VI. for further 

discussion related to TSCA section 

6(c)(2)(A) considerations, including the 

statement of effects of the proposed rule 

with respect to these considerations. 

EPA also considered the regulatory 

authorities under statutes administered 

by other agencies such as OSHA’s 

implementation of the OSH Act, as well 

as other EPA-administered statutes to 

examine: (1) whether there are 

opportunities for all or part of this risk 

management action to be addressed 

under other statutes, such that a referral 

may be warranted under TSCA sections 

9(a) or 9(b); or (2) whether TSCA section 

6(a) regulation could include alignment 

of requirements and definitions in and 

under existing statutes and regulations 

to minimize confusion to the regulated 

entities and the general public. 

In addition, EPA followed other TSCA 

requirements such as setting proposed 

compliance dates in accordance with 

the requirements in TSCA section 

6(d)(1)(B) (described in the proposed 

and alternative regulatory action in 

Units IV.A and IV.B.). 

To the extent information was 

reasonably available, EPA considered 

pollution prevention strategies and the 

hierarchy of controls adopted by OSHA 

and NIOSH when selecting regulatory 

actions, with the goal of identifying risk 

management control methods that are 

permanent, feasible, and effective (Ref. 

23). EPA also considered how to address 

the unreasonable risk while providing 

flexibility to the regulated entity where 

appropriate and took into account the 

information presented in the 2021 Risk 

Evaluation for C.I. Pigment Violet 29, as 

well as additional input from 

stakeholders (as described in Unit 

III.A.), and anticipated compliance 

strategies from regulated entities. 

Taken together, these considerations 

led EPA to the proposed regulatory 

action and primary alternative 

regulatory action described in Unit IV. 

Additional details related to how the 

requirements in this unit were 

incorporated into development of those 

actions are in Unit V. 

IV. Proposed Regulatory and 

Alternative Regulatory Actions 

This unit describes the proposed 

regulatory action by EPA so that PV29 

will no longer present an unreasonable 

risk of injury to health. In addition, as 

indicated by TSCA section 6(c)(2)(A), 

EPA must consider the costs and 

benefits and the cost-effectiveness of the 

proposed regulatory action and one or 

more primary alternative regulatory 

actions. In the case of PV29, the 

proposed regulatory action is described 

in Unit IV.A. and the primary 

alternative regulatory action considered 

is described in Unit IV.B. The rationale 

for the proposed and alternative 

regulatory actions and associated 

compliance timeframes are discussed in 

this unit and in more detail in Unit V.A. 

EPA is requesting public comment on 

the proposed regulatory action and 

alternative regulatory action, including 

whether EPA should have more 

prescriptive requirements for the 

cleaning plan. 

A. Proposed Regulatory Action 

EPA is proposing under TSCA section 

6(a) to require specific workplace 

protections, including respiratory 

protection and equipment and area 

cleaning, for certain manufacturing, 

processing, industrial, and commercial 

conditions of use. EPA is also proposing 

to require recordkeeping and to require 

manufacturers (including importers), 

processors, and distributors of PV29 for 

any use to provide downstream 

notification of requirements. 

1. Administrative and Prescriptive 

Controls 

a. Overview 

As described in Unit III.B.3, under 

TSCA section 6(a), EPA is required to 

issue a regulation applying one or more 

of the TSCA section 6(a) requirements to 

the extent necessary so that the 

unreasonable risk of injury to human 

health or the environment from the 

chemical substance is no longer present. 

The TSCA section 6(a) requirements 

provide EPA the authority to limit or 

prohibit a number of activities, 

including, but not limited to, restricting 

or regulating the manufacture, 

processing, distribution in commerce, 

commercial use, or disposal of the 

chemical substance. Given this statutory 

authority, EPA may find it appropriate 

in certain circumstances to propose 

respiratory protection requirements for 

certain occupational conditions of use 

where dry powder PV29 would be 

present (i.e., manufacturing, processing, 

industrial and commercial use, or 

disposal). This unit describes the 

proposed prescriptive respiratory 

protection requirements. 

EPA uses the term ‘‘potentially 

exposed person’’ as defined in 40 CFR 

751.5 in this unit and in the regulatory 

text to include workers (including 

occupational non-users), employees, 

independent contractors, employers, 

and all other persons in the work area 

where PV29 is present and who may be 

exposed to PV29 under the conditions 

of use for which the proposed 

respiratory protection requirements 

would apply. EPA’s proposed 

respiratory protection requirement 

would address the unreasonable risk 

from PV29 to potentially exposed 

persons directly handling the chemical 

or in the work area where the chemical 

is being used. Similarly, the 2021 PV29 

risk evaluation did not distinguish 

between employers, contractors, or 

other legal entities or businesses that 

manufacture, process, distribute in 

commerce, use, or dispose of PV29. For 

this reason, EPA uses the term ‘‘owner 

or operator’’ as defined in 40 CFR 751.5 

to describe the entity responsible for 

implementing the respiratory protection 

requirements in any workplace where 

the proposed respiratory protection 

requirements would apply. The term 

includes any person who owns, leases, 

operates, controls, or supervises such a 

workplace. 

EPA also uses the term ‘‘regulated 

PV29’’ in the proposed regulatory action 

to describe PV29 in a dry powder form 

or in dry powder form when mixed with 

other types of dry powder pigments. 

Additional discussion is found in Unit 

V. 

EPA is proposing respiratory 

protection requirements and equipment 

and area cleaning requirements for the 

following conditions of use in cases in 

which regulated PV29 is manufactured, 

processed, used, or disposed of: 

• Domestic manufacture. 

• Import. 

• Processing: Incorporation into 

formulation, mixture, or reaction 

products in paints and coatings. 

• Processing: Incorporation into 

formulation, mixture, or reaction 

products in plastic and rubber products. 

• Processing: intermediate in the 

creation or adjustment of color of other 

perylene pigments. 

• Processing: recycling. 

• Industrial and commercial use in 

automobile paints and coatings (original 

equipment manufacturing and 

refinishing). 

• Industrial and commercial use in 

coatings and basecoats for paints and 

coatings. 


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• Industrial and commercial use in 

merchant ink for commercial printing. 

• Disposal. 

b. PV29 Regulated Area 

EPA is proposing to require that 

owners or operators of workplaces 

subject to regulated PV29 respiratory 

protection or cleaning requirements 

demarcate any area where regulated 

PV29 exposures can reasonably be 

expected to occur, meaning that where 

a regulated PV29 container is open or in 

use, equipment containing regulated 

PV29 is in use or has not yet been 

cleaned, the area where equipment for 

regulated PV29 has not yet been cleaned 

since equipment usage has ceased, or 

cleaning activities are occurring. PV29 

regulated areas would be demarcated 

using administrative controls, such as 

warning signs or highly visible 

signifiers, in multiple languages as 

appropriate (e.g., based on languages 

spoken by potentially exposed persons), 

placed in conspicuous areas, and 

documented through training and 

recordkeeping. The owner or operator 

would be required to restrict access to 

the PV29 regulated area from any 

potentially exposed person that lacks 

proper training, is not wearing required 

respiratory protection as described in 

this unit or is otherwise unauthorized to 

enter. EPA is proposing to require 

owners and operators demarcate a PV29 

regulated area beginning 180 days after 

the date of publication of the final rule. 

EPA is soliciting comment on requiring 

warning signs to demarcate PV29 

regulated areas, such as the 

requirements found in OSHA’s General 

Industry Standard for Beryllium (29 

CFR 1910.1024(m)(2)). 

c. Respiratory Protection Requirements 

EPA is proposing to require the use of 

respirators with a minimum assigned 

protection factor (APF) of 50, in general 

alignment with OSHA’s Respiratory 

Protection Standard at 29 CFR 

1910.134. Owners and operators would 

be required to provide respiratory 

protection selected in accordance with 

the guidelines described in this unit, 

that is of safe design and construction 

for the work to be performed. EPA is 

proposing to require that owners and 

operators (1) provide respirators to each 

potentially exposed person, (2) ensure 

respirator use, and (3) maintain 

respirators in a sanitary, reliable, and 

undamaged condition. Owners and 

operators would be required to select 

and provide a respirator that properly 

fits and communicate respirators 

selections each potentially exposed 

person. 

EPA is proposing to require 

respiratory protection with worksitespecific procedures and elements for 

required respirator use. The proposed 

respiratory protection requirements 

would be required when dry powder 

PV29 is present in the workplace as 

described in this unit. EPA is proposing 

to require each owner or operator to 

select respiratory protection in 

accordance with the requirements 

described in this unit and also to 

comply with OSHA’s Respiratory 

Protection Standard at 29 CFR 1910.134 

(a) through (l), with the exception of (d) 

and (a)(1), for selection, proper use, 

maintenance, fit-testing, medical 

evaluation, and training when using 

respirators. The respiratory protection 

requirements must be administered by a 

suitably trained administrator, in 

accordance with OSHA’s Respiratory 

Protection Standard at 29 CFR 

1910.134(c). This administrator would 

need to be qualified by appropriate 

training or experience that is 

commensurate with the complexity of 

the program to administer or oversee the 

respiratory protection program and 

conduct the required evaluations of 

program effectiveness. EPA is proposing 

that owners and operators would 

provide respirator training to each 

potentially exposed person who is 

required by this unit to wear respirators 

prior to or at the time of initial 

assignment to a job involving potential 

exposure to PV29. Owners and 

operators would also have to re-train 

each affected person at least once 

annually or whenever the owner or 

operator has reason to believe that a 

previously trained person does not have 

the required understanding and skill to 

properly use respirators, or when 

changes in the workplace or in the 

respirator to be used render the previous 

training obsolete. 

EPA is proposing to require each 

owner or operator supply a respirator, in 

accordance with the APF 50 

requirements explained in this unit, to 

each potentially exposed person who 

enters an area with regulated PV29 

present within six months after 

publication of the final rule and to 

ensure that all potentially exposed 

persons are using the provided 

respirators whenever dry powder PV29 

exposures are expected. EPA recognizes 

that implementing respiratory 

protection requirements may require 

different compliance timeframes 

depending on existing health and safety 

programs at various facilities. EPA is 

soliciting comment on whether six 

months is a reasonable timeframe to 

implement respiratory protection 

requirements or if a different timeframe 

is appropriate. Additionally, EPA is 

proposing that the owner or operator 

must ensure that all filters, cartridges, 

and canisters associated with 

respiratory protection used in the 

workplace are labeled and color coded 

with the NIOSH approval label and that 

the label is not removed and remains 

legible. EPA is requesting comment on 

whether there should be a requirement 

for a minimum service life of nonpowered air-purifying respirators such 

as the requirements found in OSHA’s 

General Industry Standard for Benzene 

(29 CFR 1910.1028(g)(3)(D)). 

EPA is proposing to establish 

minimum respiratory protection 

requirements, with the requirement for 

the use of at least an APF 50 respirator, 

such that any respirator affording a 

higher degree of protection than the 

following proposed requirements may 

be used. EPA does not anticipate that 

respirators beyond APF 50 will be 

widely or regularly used to address 

unreasonable risk. APF 50 respirators 

that can be used to mitigate the 

unreasonable risk of injury to health 

were provided in the risk evaluation in 

Table 2–7 (Ref. 1) and include: any 

NIOSH-certified half-mask power airpurifying respirator; any NIOSHcertified half-mask supplied-air 

respirator or airline respirator in 

continuous flow mode or pressuredemand or other positive pressure 

mode; any NIOSH-certified full 

facepiece air-purifying respirator; any 

NIOSH-certified full facepiece supplied 

air respirator or airline respirator 

(demand mode); any NIOSH-certified 

full facepiece self-contained breathing 

apparatus (demand mode); or any 

NIOSH-certified helmet/hood selfcontained breathing apparatus (demand 

mode). Negative-pressure respirators are 

acceptable for use if they meet the APF 

50 requirement. 

d. Workplace Information and Training 

EPA is proposing that the 

implementation of the respiratory 

protection requirements be done in 

compliance with the training and 

information requirements in OSHAs 

Respiratory Protection Standard at 29 

CFR 1910.134(k). EPA is requesting 

comment on whether to require owners 

or operators to provide additional 

workplace training in areas where 

regulated PV29 is present. 

e. Equipment and Area Cleaning 

Requirements 

EPA is proposing that each owner or 

operator create and implement a 

cleaning plan for equipment and area 

cleaning where regulated PV29 has been 


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manufactured, processed, used, or 

disposed of. As part of the cleaning 

plan, owners and operators would be 

required to describe the cleaning 

method, materials, and procedure to be 

used for cleaning activities and would 

be required to clean the equipment and 

area, as well as the procedure to be used 

to assess the effectiveness of the 

cleaning activities. The cleaning 

method, materials, and procedure 

would be determined by the owner or 

operator. 

As part of the equipment and area 

cleaning requirements, EPA is 

proposing to require equipment and the 

area in which the equipment is housed 

to be cleaned within 24 hours following 

manufacturing, processing, use or 

disposal of regulated PV29. Surfaces of 

the equipment that have contact with 

regulated PV29 as part of operation or 

the area where the equipment is located 

would need to be free of residue, 

meaning that no residue is left on 

surfaces in the area, such as the outer 

housing of equipment and places where 

dust-like particles typically settle, such 

as the floor; for example, a wet, white 

cloth, swab, or other similar cleaning 

fabric will not have visible color after 

contact with the surface. 

EPA is proposing to require each 

owner or operator to provide 

information and instructions for the 

cleaning plan to each person prior to or 

at the time of initial assignment to a job 

involving potential exposure to 

equipment or an area in which regulated 

PV29 is manufactured, processed, used, 

or disposed of within six months after 

the date of publication of the final rule 

in the Federal Register. 

f. Compliance Timeframes 

EPA is proposing that each owner or 

operator must provide respiratory 

protection of at least AFF 50 to all 

potentially exposed persons in areas 

where regulated PV29 is present and 

develop and implement a cleaning plan 

for equipment and area cleaning where 

regulated PV29 has been manufactured, 

processed, used, or disposed of, within 

six months after the date of publication 

of the final rule in the Federal Register. 

EPA is also proposing to require each 

owner or operator to provide 

information and training for each person 

prior to or at the time of initial 

assignment to a job involving potential 

exposure to regulated PV29 within six 

months after the date of publication of 

the final rule in the Federal Register. 

EPA will consider compliance 

timeframes that may be substantially 

longer or shorter than the proposed 

timeframes for owners or operators for 

procedural adjustments needed to 

comply with the requirements outlined 

in this unit and is requesting comment 

on the feasibility of the proposed 

compliance timeframes, as well as 

longer or shorter timeframes. 

2. Other Requirements 

a. Recordkeeping 

EPA is proposing that manufacturers, 

processors, distributors, and industrial 

and commercial users of regulated PV29 

maintain ordinary business records, 

such as invoices and bills-of-lading, that 

demonstrate compliance with the 

restrictions and other provisions of this 

proposed regulation; and maintain such 

records for a period of five years from 

the date the record is generated. EPA is 

proposing that this requirement begin at 

the effective date of the final rule. 

Recordkeeping requirements would 

ensure that owners or operators can 

demonstrate compliance with the 

regulations if necessary. 

Additionally, to support and 

demonstrate compliance, EPA is 

proposing that owners and operators of 

a workplace subject to the respiratory 

protection requirements and/or the area 

and equipment cleaning requirements 

retain compliance records for five years. 

These proposed requirements are not 

intended to supersede or otherwise 

relieve regulated entities from any 

recordkeeping requirement imposed by 

other federal laws or regulations. EPA is 

proposing to require records to include: 

(A) Implementation of the respiratory 

protection requirements and 

documentation, including as necessary, 

respiratory protection used and related 

training; 

(B) Information and training provided 

to each person prior to or at the time of 

initial assignment and any retraining; 

(C) Cleaning plan implementation and 

documentation, including as necessary, 

related instructions; and 

(D) Information and instructions 

provided to each person prior to or at 

the time of initial assignment and any 

updates to the information and 

instructions received. 

The owners and operators, upon 

request by EPA, would be required to 

make such records available to EPA for 

examination and copying. All records 

required to be maintained under this 

proposed rule could be kept in the most 

administratively convenient form 

(electronic or paper). 

b. Downstream Notification and 

Labeling 

EPA is proposing that manufacturers 

(including importers), processors, and 

distributors of regulated PV29 provide 

downstream notification through Safety 

Data Sheets (SDSs) by adding the 

language set forth in proposed 40 CFR 

751.907(b) to sections 1(c) and 15 of the 

SDS. Additionally, EPA is proposing 

that every regulated PV29 product bear 

a label that appears on or is securely 

attached to the immediate container of 

the PV29 product, and that the contents 

of a label must show clearly and 

prominently the language set forth in 

proposed 40 CFR 751.907(c). In order to 

provide adequate time to undertake the 

changes to the SDS and ensure that all 

processors and distributors of regulated 

PV29 in the supply chain receive the 

revised SDS, EPA is proposing a 6- 

month period for manufacturers, 

processors, and distributors to 

implement the proposed SDS changes 

following publication of the final rule. 

EPA is also proposing a 6-month period 

for manufacturers, processors, and 

distributors to implement the labeling 

requirement following publication of 

the final rule. 

EPA requests comment on the 

timeframes for recordkeeping and 

downstream notification requirements 

described in this Unit. 

B. Primary Alternative Regulatory 

Action 

As indicated by TSCA section 

6(c)(2)(A)(iv)(II) and (III), EPA must 

consider the cost and benefits and the 

cost effectiveness of the proposed 

regulatory action and one or more 

primary alternative regulatory actions 

considered by the Agency. 

The primary alternative regulatory 

action uses prescriptive workplace 

controls to address the unreasonable 

risk from PV29 contributed to by the 

various conditions of use. EPA requests 

comment on this primary alternative 

regulatory action and whether any 

elements of the primary alternative 

regulatory action described in this Unit 

should be considered as EPA develops 

the final regulatory action. 

1. Requirements for Manufacturing and 

Processing Conditions of Use, Other 

Than Recycling 

a. Overview 

The primary alternative regulatory 

action considered by the EPA would 

require workplace controls, including 

engineering controls and respiratory 

protection for the following conditions 

of use in cases in which regulated PV29 

is manufactured or processed: 

• Domestic manufacture; 

• Import; 

• Processing: Incorporation into 

formulation, mixture, or reaction 

products in paints and coatings; 

• Processing: Incorporation into 

formulation, mixture, or reaction 


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products in plastic and rubber products; 

and 

• Processing: intermediate in the 

creation or adjustment of color of other 

perylene pigments. 

b. Engineering Controls 

The proposed alternative regulatory 

action would include the use of 

engineering controls to mitigate the 

unreasonable risk of injury to health. 

Engineering controls, such as HEPA 

filters and other forms of air filtration, 

would be required to reduce the 

concentration of regulated PV29 in 

workplace air. As part of this effort, EPA 

would adopt OSHA’s general 

monitoring method for respirable dust 

under 29 CFR 1910.1000 for PNORs, i.e., 

NIOSH 0600, as the workplace air 

monitoring method in the proposed 

alternative regulatory action to confirm 

that the air concentration of regulated 

PV29 is at or the NIOSH 0600 limit of 

detection (LOD, 0.5 mg/m3). Under the 

proposed alternative regulatory action, 

EPA would use NIOSH method 0600 in 

place of a chemical-specific monitoring 

method because no analytical 

monitoring method currently exists for 

PV29. The respirable dust method 

would be used in place of a chemicalspecific monitoring method to have a 

way of measuring airborne regulated 

PV29 workplace exposure. Monitoring 

would be required to occur at least once 

every 3 months during when regulated 

PV29 is manufactured or is in use. If the 

concentration of airborne dust is above 

the NIOSH 0600 LOD, monitoring 

would need to occur at least once every 

3 months. If the concentration of 

airborne dust is below the LOD, 

monitoring would need to occur at least 

once every 6 months. 

c. PV29 Regulated Area 

Similar to the proposed regulatory 

action, under the primary alternative 

regulatory action EPA would require 

that owners or operators of workplaces 

subject to regulated PV29 respiratory 

protection or cleaning requirements 

demarcate any area where regulated 

PV29 exposures can reasonably be 

expected to occur, meaning where a 

regulated PV29 container is open or in 

use, equipment containing regulated 

PV29 is in use or has not yet been 

cleaned, the area where equipment for 

regulated PV29 has not yet been cleaned 

since equipment usage has ceased, or 

cleaning activities are occurring. 

Regulated areas would be demarcated 

using administrative controls, such as 

warning signs or highly visible 

signifiers, in multiple languages as 

appropriate (e.g., based on languages 

spoken by potentially exposed persons), 

placed in conspicuous areas, and 

documented through training and 

recordkeeping. The owner or operator 

would be required to restrict access to 

the regulated area from any potentially 

exposed person that lacks proper 

training, is not wearing required 

respiratory protection as described in 

this unit or is otherwise unauthorized to 

enter. EPA would propose to require 

owners and operators demarcate a 

regulated area beginning 180 days after 

the date of publication of the final rule. 

EPA is soliciting comment on requiring 

warning signs to demarcate regulated 

areas, such as the requirements found in 

OSHA’s General Industry Standard for 

Beryllium (29 CFR 1910.1024(m)(2)). 

d. Respiratory Protection Requirements 

As shown in Unit IV.A.1, the 

proposed regulatory action would 

include the requirement for potentially 

exposed persons to wear an APF 50 

respirator in the PV29 regulated area. 

Under the primary alternative regulatory 

action, potentially exposed persons 

would be required to wear an APF 10 

respirator. Even though there would be 

workplace air monitoring performed 

under the primary alternative regulatory 

action, EPA is uncertain if the 

concentration of regulated PV29 in 

workplace air would be low enough to 

not result in unreasonable risk of injury 

to health. Therefore, respirator use 

would be required as a safeguard to 

ensure that the unreasonable risk is 

mitigated for potentially exposed 

persons. EPA requests comment on the 

approach of using respirators and 

engineering controls in tandem to 

mitigate the unreasonable risk of injury 

to health. 

e. Equipment and Area Cleaning 

Requirements 

The primary alternative regulatory 

action equipment and area cleaning 

requirements would be the same as 

those for the proposed regulatory action. 

This would ensure that the 

concentration of regulated PV29 in 

workplace air is as low as possible. 

f. Recordkeeping and Labeling 

The primary alternative regulatory 

action recordkeeping requirements 

would be different from those for the 

proposed regulatory action. The 

alternative regulatory action would 

require recordkeeping for the 

engineering controls implemented. The 

respiratory protection and equipment 

and area cleaning requirements for 

recordkeeping would be the same, as 

owners and operators would be required 

to maintain respiratory protection and 

equipment and area cleaning records. 

However, unlike the proposed 

regulatory action, the primary 

alternative regulatory action would not 

include a labeling requirement for 

containers storing regulated PV29. 

2. Requirements for Recycling, 

Industrial and Commercial Conditions 

of Use 

The primary alternative regulatory 

action EPA considered would require 

respiratory protection and equipment 

and area cleaning, with different 

recordkeeping requirements, for the 

following conditions of use in cases in 

which PV29 is processed, used, or 

disposed as a dry powder pigment: 

• Processing: recycling; 

• Industrial and commercial use in 

automobile paints and coatings (original 

equipment manufacturing and 

refinishing); 

• Industrial and commercial use in 

coatings and basecoats for paints and 

coatings; 

• Industrial and commercial use in 

merchant ink for commercial printing; 

and 

• Disposal; 

The primary alternative regulatory 

action respiratory protection 

requirements would be the same as 

those for the proposed regulatory action. 

This would include the requirement for 

potentially exposed persons to use AFP 

50 respirators in PV29 regulated areas. 

It would also include the requirement 

for a PV29 regulated area as described 

in the proposed regulatory action. 

The primary alternative regulatory 

action equipment and area cleaning 

requirements would be the same as 

those for the proposed regulatory action. 

This would ensure that the 

concentration of regulated PV29 in 

workplace air is as low as possible. 

The primary alternative regulatory 

action recordkeeping requirements 

would be different from those for the 

proposed regulatory action. The 

respiratory protection and equipment 

and area cleaning requirements for 

recordkeeping would be the same, as 

owners and operators would be required 

to maintain records of the respiratory 

protection and equipment and area 

cleaning records. However, unlike the 

proposed regulatory action, the primary 

alternative regulatory action would not 

include a recordkeeping requirement to 

collect and retain records of regulated 

PV29 purchase for a period of five years. 

The Agency would not require a 

recordkeeping requirement under the 

primary alternative regulatory action 

because the respiratory protection 

requirements and equipment and area 

cleaning requirements in cases when 

regulated PV29 is present would 


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provide sufficient information to 

indicate that regulated PV29 was 

purchased. 

V. Rationale for the Proposed 

Regulatory and Primary Alternative 

Regulatory Actions 

This unit describes how the 

considerations described in Unit III.B.3 

were applied when selecting among the 

TSCA section 6(a) requirements to 

arrive at the proposed and primary 

alternative regulatory actions described 

in Unit IV.A and IV.B. 

A. Consideration of Risk Management 

Requirements Available Under TSCA 

Section 6(a) 

1. Prescriptive Controls 

An option EPA considered was 

requiring specific, prescribed controls— 

such as engineering controls, 

administrative controls, and PPE 

(including respiratory protection)—to 

reduce exposures to PV29 in 

occupational settings. Prescriptive 

controls could include respirators. The 

Agency identified that respiratory 

protection could reduce exposures to 

PV29 to where it no longer presents 

unreasonable risk. However, for all 

conditions of use, EPA understands that 

the use of prescriptive respiratory 

protection is the lowest on the hierarchy 

of controls, which is in the following 

order of greatest to least effectiveness: 

elimination, substitution, engineering 

controls, administrative controls, and 

PPE (Ref. 23). EPA also understands that 

workplaces have unique processes and 

equipment in place and that varying 

types of respiratory protection may be 

needed for different workplaces. 

However, due to the lack of an available 

chemical specific monitoring method 

for PV29, EPA proposes the use of 

respiratory protection, specifically APF 

50 respirators. APF 50 respirators were 

found to be the minimum level of 

respiratory protection that could 

mitigate the unreasonable risk of injury 

to health (Ref. 1). 

During risk management, the Agency 

worked to understand the industries 

that could be potentially impacted by 

EPA regulatory requirements and 

considered their use of PV29 and PV29- 

containing products compared to the 

inhalation exposure human health risks 

presented in the 2021 Risk Evaluation 

for C.I. Pigment Violet 29 and the 2022 

Revised Unreasonable Risk 

Determination. The 2022 Revised 

Unreasonable Risk Determination for 

PV29 states that EPA’s unreasonable 

risk determination for PV29 is driven by 

risks of injury to health associated with 

10 conditions of use, including 

manufacturing (including import), 

processing, and some industrial and 

commercial conditions of use. Five 

downstream conditions of use that 

contribute to the unreasonable risk of 

injury to health of PV29—processing: 

recycling; industrial and commercial 

use: paints and coatings—automobile 

(original equipment manufacturing and 

refinishing); industrial and commercial 

use: paints and coatings—coatings and 

basecoats; industrial and commercial 

use: merchant ink for commercial 

printing; and disposal—involve the use 

or breakdown, in the case of recycling 

and disposal, of products containing 

PV29, such as paint and plastics. 

During the SBAR Panel process, SERs 

were represented for each of the five 

downstream conditions of use as well as 

the other conditions of use that were 

found to contribute to the unreasonable 

risk of injury to health. SERs 

commented about how they could be 

impacted by a potential PV29 

rulemaking in their industries, 

including their use of PV29, engineering 

controls and PPE already used, and how 

they use and handle PV29 (dry powder, 

paint, plastic, etc.). As part of the SBAR 

Panel meeting, SERs were asked if PV29 

was used in a dry powder or non-dry 

powder form, such as a slurry or paste, 

and when after being mixed into paint, 

what types of equipment and PPE were 

used for PV29-containing paint 

application activities. The questions 

included potential risk of injury to 

health from inhalation exposure to paint 

containing PV29 during automotive 

spray painting, sanding, grinding, and 

repair service activities (Ref. 3). SERs in 

the automotive industry stated that they 

do not use dry powder PV29 and do not 

mix their own pigments; the paints they 

use for automotive refinishing activities 

are provided from automotive and paint 

and coating manufacturers (Ref. 3). 

Additionally, SERs in the printing ink 

manufacturing and graphic arts 

industries stated that, to their 

knowledge, PV29 is not used in their 

industries (Ref. 3). Written comments 

submitted to the SBAR Panel by a paint 

and coatings SER specifically 

mentioned the Proposition 65 regulation 

in California, where crystalline silica 

and titanium dioxide are listed as 

carcinogens specifically for airborne 

particles of respirable size and airborne, 

unbound particles of respirable size, 

respectively (Refs. 3, 4). Carbon black, 

the analog used for PV29’s toxicity, is 

also listed in the Proposition 65 

regulation under a similar description to 

titanium dioxide, as a carcinogen 

specifically when as airborne, unbound 

particles of respirable size. 

Notably, the risk evaluation and 

revised risk determination state that two 

conditions of use, industrial and 

commercial uses in finished plastic and 

rubber products for automobile plastics 

and industrial carpeting, do not 

contribute to the unreasonable risk of 

injury to health of PV29 because the 

Agency assumed that PV29 powder was 

incorporated into the materials under 

these conditions of use and there would 

be no exposure to PV29 as a dust (Refs. 

1, 2). These two conditions of use have 

similar types of materials compared to 

the five downstream conditions of use 

mentioned previously: processing: 

recycling; industrial and commercial 

use: paints and coatings—automobile 

(original equipment manufacturing and 

refinishing); industrial and commercial 

use: paints and coatings—coatings and 

basecoats; industrial and commercial 

use: merchant ink for commercial 

printing; and disposal. Additionally, in 

the 2021 Risk Evaluation for C.I. 

Pigment Violet 29, where EPA stated 

that PV29 present in dried paint and 

plastic products is expected to be 

encapsulated and available physical and 

chemical property information indicates 

that due to a low solubility in water and 

octanol, it is not expected to leach out 

(Ref. 1, p. 59). EPA also stated in the 

risk evaluation that PV29 is not 

expected to be reactive or leachable 

either as a neat material or encapsulated 

in plastics or paint resins (Ref. 1, p. 65). 

Taken together, the statements in the 

risk evaluation support information 

received as part of the SBAR Panel 

process during the development of this 

proposed rule, where commenters stated 

that, in their experience, pigments with 

a dry powder form like PV29, including 

carbon black, do not present the same 

inhalation exposure risk after they are 

mixed into solution and encapsulated 

(Ref. 3). 

The Agency considered the 

information in the risk evaluation and 

the comments provided as part of SBAR 

during stakeholder meetings and in 

public comments during the 

development of this rule. The comments 

showed that these conditions of use may 

not result in occupational exposures to 

dry powder PV29. As stated in Unit 

II.B.3, EPA has issued a memo (Ref. 5), 

in which the Agency intended to 

provide clarity about exposure-related 

statements made since the publication 

of the risk evaluation. This memo states 

that the risk assessed in the 2021 Risk 

Evaluation for C.I. Pigment Violet 29 is 

associated with inhalation exposures of 

C.I. Pigment Violet 29 in manufacturing 

and processing as particles in the dry 

powder form. Exposure to paint aerosols 


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containing PV29 was not assessed in the 

risk evaluation. The conclusions of the 

memo are supported by the following 

sections of the risk evaluation which 

note that PV29 encapsulated in plastics, 

paints, and inks are not expected to be 

reactive or leachable, and therefore, not 

likely to be biologically available when 

not in dry powder form: 

• Section 1.1 addresses the physicalchemical properties of PV29 and states 

it is extremely insoluble in water or 

other organic solvents and has a very 

low vapor pressure. 

• Section 1.4.1.3 cites information 

provided by a stakeholder about the 

encapsulation of PV29 in plastic resins 

due to its low solubility in water and 

octanol. 

• Section 1.4.1.4 states inhalation is 

not identified as a route of exposure for 

commercially available watercolor or 

acrylic paints due to low vapor pressure 

of PV29. 

• Section 2.3.2 states inhalation is not 

an expected route of exposure for 

commercially available watercolor and 

acrylic paints and that dermal and oral 

absorption is expected to be limited 

from the same source due to low water 

solubility. 

Taken together, the information and 

statements in the memo clarify that EPA 

agrees when PV29 is incorporated into 

the matrix of paint and other liquid 

media, such as ink, it does not retain the 

original dry particle properties of its 

original form. This information applies 

to automotive spray painting, sanding, 

grinding and repair services, since they 

involve use of dried paint containing 

PV29. In these instances, PV29 has been 

used within a mixture and is no longer 

bioavailable in its dry powder form. 

Per the SBAR Panel’s 

recommendation, the Agency also 

considered tailoring the applicability of 

requirements for entities that can 

demonstrate they do not use dry powder 

PV29, if the requirements are sufficient 

so that PV29 no longer presents 

unreasonable risk. 

The risk evaluation states inhalation 

exposure to dry powder PV29 is not 

expected for two conditions of use in 

which PV29 has been incorporated into 

a product, similar to the five 

downstream conditions of use. Given 

that (1) unreasonable risk is dependent 

on exposure to a chemical substance 

and (2) the products used in the five 

downstream conditions of use are 

unlikely to be dry powder PV29 based 

on public comment and SBAR feedback, 

the Agency acknowledges that the 

likelihood of exposure to dry powder 

PV29 may be low for five conditions of 

use—processing: recycling; industrial 

and commercial use: paints and 

coatings—automobile (original 

equipment manufacturing and 

refinishing); industrial and commercial 

use: paints and coatings—coatings and 

basecoats; industrial and commercial 

use: merchant ink for commercial 

printing; and disposal. However, as 

there would still be unreasonable risk of 

injury to health if dry powder PV29 is 

used, the proposed regulatory 

requirements would be triggered only 

when dry powder PV29 is present. Per 

the SBAR Panel’s recommendation, EPA 

is requesting comment on this approach, 

specifically how to mitigate the 

exposure to dry powder PV29, by 

entities that could, based on 

demonstrated ability through 

recordkeeping and utilization of a 

combination of controls (including 

engineering controls, administrative 

controls, and PPE requirements), 

eliminate inhalation exposure to PV29 

to address the unreasonable risk. 

2. Equipment and Area Cleaning 

Requirements 

Prescriptive controls that the EPA 

could require include administrative 

controls. The use of cleaning 

requirements is proposed with 

administrative controls in mind, with 

the goal of reducing overall exposure to 

regulated PV29 in a holistic way by 

using multiple controls on the hierarchy 

of controls in place of engineering 

controls. The Agency acknowledges that 

administrative controls, in the form of a 

cleaning of the equipment and the area 

where regulated PV29 is handled, are 

only one step higher on the hierarchy of 

controls than respiratory protection but 

believes that their implementation 

would be complementary with the use 

of respiratory protection to address the 

unreasonable risk. In particular, the 

Agency chose this path in part because 

it is difficult to verify the effectiveness 

of engineering controls for mitigating 

the unreasonable risk regarding 

regulated PV29 because a chemicalspecific air monitoring method does not 

currently exist. The Agency also chose 

this path because, as part of SBAR 

comments, the Agency learned that the 

manufacturer of regulated PV29 

produces regulated PV29 infrequently 

over the course of twelve 12-hour shifts 

per year with 2 workers. 

3. Primary Alternative Regulatory 

Action 

EPA acknowledges that for all 

conditions of use in which it is 

proposing to require the use of 

respirators, the types of facilities that 

would use regulated PV29 may be able 

to implement engineering controls and 

respiratory protection, as these 

conditions of use occur in industrial 

settings. Therefore, for EPA’s primary 

alternative regulatory action, described 

in Unit IV.B., EPA is requesting 

comment on whether any of the uses the 

Agency is proposing to implement 

respiratory protection requirements for 

could be better served by requiring 

exposure controls in accordance with 

the hierarchy of controls, including but 

not limited to engineering controls in 

tandem with respiratory protection. 

As discussed in this unit, in the PV29 

Risk Evaluation, EPA identified that 

respiratory protection could reduce 

exposures in support of risk 

management efforts for PV29 and is 

proposing prescriptive controls, 

specifically respirators, as part of the 

primary regulatory option. EPA 

recognizes the potential for there to be 

other forms of controls to prevent 

inhalation exposure to regulated PV29. 

Therefore, as part of the alternative 

regulatory action, EPA considered 

requiring use of engineering controls for 

five conditions of use that contribute to 

the unreasonable risk of injury to health 

where the Agency believes regulated 

PV29 is commonly present— 

manufacturing (including import and 

domestic manufacturing), processing: 

incorporation into formulation, mixture 

or reaction products in paints and 

coatings and in plastic and rubber 

products, and processing: intermediate 

in the creation or adjustment of color of 

other perylene pigments. 

For the primary alternative regulatory 

action, for the conditions of use where 

the Agency does not believe dry powder 

PV29 is commonly present—processing: 

recycling; industrial and commercial 

use: paints and coatings—automobile 

(original equipment manufacturing and 

refinishing); industrial and commercial 

use: paints and coatings—coatings and 

basecoats; industrial and commercial 

use: merchant ink for commercial 

printing; and disposal—the Agency 

would require owners and operators to 

follow the respiratory protection and 

equipment and area cleaning 

requirements outlined in the proposed 

action for these conditions of use when 

regulated PV29 is purchased. This 

includes the use of APF 50 respirators 

and implementation of a cleaning plan. 

Stakeholder feedback indicated that 

there could be varying workplace 

conditions and settings where it would 

be possible to use regulated PV29, so the 

Agency believes that respiratory 

protection and a cleaning plan would be 

more feasible to require and implement 

compared to engineering controls. A key 

difference between the primary 

alternative regulatory action and the 

proposed action is the requirement to 


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implement respiratory protection and 

cleaning requirements if PV29 is 

manufactured or purchased. Under the 

primary alternative regulatory action, 

respiratory protection and a cleaning 

plan would always be required 

regardless of whether an entity under 

the condition of use manufactures or 

purchases regulated PV29. 

4. Risk Management Requirements 

Considered but Not Proposed 

EPA considered a prohibition as a 

regulatory option but has found that a 

different regulatory action would 

address the unreasonable risk. In 

addition, EPA considered the 

information provided regarding 

alternatives for the use of PV29 as a 

pigment in paints and coatings. Industry 

described their efforts to explore 

alternatives but have not been 

successful in finding a suitable 

replacement (Ref. 3). 

EPA also considered the option of 

establishing a Workplace Chemical 

Protection Program (WCPP) for 

occupational conditions of use, which 

would have included a combination of 

restrictions to address unreasonable risk 

contributed to by inhalation exposures 

in the workplace. A WCPP for PV29 

would have encompassed restrictions 

on certain occupational conditions of 

use and could have included provisions 

for an Existing Chemical Exposure Limit 

(ECEL), an airborne concentration 

generally calculated as an eight (8)-hour 

time-weighted average (TWA), and 

ancillary requirements to support 

implementation of these restrictions. 

The WCPP requirement for PV29 would 

have been a non-prescriptive, 

performance-based exposure limit that 

would enable owners or operators to 

determine how to most effectively meet 

the exposure limits based on conditions 

at their workplace following the 

hierarchy of controls. However, EPA 

was unable to identify an existing 

chemical-specific inhalation exposure 

monitoring method for PV29. 

Additionally, EPA was also unable to 

identify an existing general workplace 

dust inhalation exposure monitoring 

method with a limit of detection lower 

than the calculated ECEL (0.014 mg/m3

for inhalation exposures as an 8-hour 

Time Weighted Average in workplace 

settings) to ensure that there would be 

no unreasonable risk of injury to health 

for potentially exposed persons. EPA is 

requesting comment on monitoring for 

inhalation exposures to PV29, including 

the amount of time needed to develop 

an inhalation exposure monitoring 

method or how to use existing 

monitoring methods for other chemicals 

(See Unit V.5). 

5. Additional Considerations 

After considering the different 

regulatory options under TSCA section 

6(a), lack of alternatives (described in 

Unit V.B.), compliance dates, and other 

requirements under TSCA section 6(c), 

EPA developed the proposed regulatory 

action described in Unit IV.A. to 

address the unreasonable risk from 

PV29. To ensure successful 

implementation of this proposed 

regulatory action, EPA considered other 

requirements to support compliance 

with the proposed regulations, such as 

requiring respirators and recordkeeping 

to demonstrate compliance with the 

respirator requirement, or downstream 

notification regarding the respirator 

requirements for use of dry powder 

PV29 in manufacturing, processing, and 

distribution in commerce. These 

proposed requirements are described in 

Unit IV.A. 

Based on reasonably available 

information, EPA has found that a TSCA 

section 6(g) exemption is not warranted 

at this time. Therefore, EPA is not 

proposing to grant exemptions from the 

rule requirements under TSCA section 

6(g). 

As required under TSCA section 6(d), 

any rule under TSCA section 6(a) must 

specify mandatory compliance dates, 

which shall be as soon as practicable 

with a reasonable transition period, but 

no later than five years after the date of 

promulgation of the rule (except in the 

case of a use exempted under TSCA 

section 6(g) or for full implementation 

of ban or phase-out requirements). 

These compliance dates are detailed in 

Unit IV.A. and IV.B. 

SBAR Panel Recommendations. SBAR 

Panel information, including Panel’s 

recommendations, was considered 

throughout the rulemaking process. The 

Panel’s seven recommendations are 

specifically reflected in this document. 

Recommendation 1. The Panel 

recommends that the EPA consider and 

request comment on how to mitigate the 

exposure to PV29, in particular the 

pure, dry/powder PV29, by entities that 

could, based on demonstrated ability 

through recordkeeping and utilization of 

a combination of controls (including 

engineering controls, administrative 

controls, and PPE requirements), 

eliminate inhalation exposure to PV29 

to address the unreasonable risk. 

EPA considered the recommendation 

and the Agency has considered and 

requests comment on how to mitigate 

the exposure to PV29, in particular the 

pure, dry/powder PV29, by entities that 

could, based on demonstrated ability 

through recordkeeping and utilization of 

a combination of controls (including 

engineering controls, administrative 

controls, and PPE requirements), 

eliminate inhalation exposure to PV29 

to address the unreasonable risk. 

Recommendation 2. The Panel 

recommends that the EPA consider not 

prohibiting the use of PV29. Instead, the 

Panel recommends that the EPA 

consider the assumptions in the Risk 

Evaluation to identify requirements that 

focus on the exposures that are 

contributing to the unreasonable risk, in 

particular the pure, dry/powder PV29, 

as compared to PV29 embedded in a 

matrix. Additionally, as part of this 

effort, the Panel recommends that the 

EPA provide and request comment in 

the Notice of Proposed Rulemaking 

(NPRM) on reasonable compliance 

timeframes for small businesses, with 

emphasis on comment about how to 

provide longer compliance timeframes 

for transitioning to uses requiring 

reformulation. 

EPA considered the recommendation 

and the Agency is not proposing to 

prohibit the use of PV29 in any fashion 

under the conditions of use that 

contribute to the unreasonable risk of 

injury to health. Additionally, as part of 

this panel recommendation, EPA 

considered the assumptions in the Risk 

Evaluation to identify requirements that 

focus on the exposures that are 

contributing to the unreasonable risk, in 

particular the pure, dry/powder PV29, 

as compared to PV29 embedded in a 

matrix. The Agency’s consideration of 

these points is reflected in the proposed 

and alternative regulatory options, as 

described in Unit IV and with 

additional rationale provided in Unit V. 

Recommendation 3. The Panel 

recommends that the EPA provide 

readily available information on 

potential costs that could be incurred 

using strategies to meet requirements for 

any proposed exposure controls, such as 

engineering, administrative, or 

prescriptive controls e.g., use of 

specialized systems, cost of new 

equipment, PPE use), or concentration 

limit, as they apply to each relevant 

COU. The Agency should also provide 

its analysis on whether it is feasible to 

implement these strategies for the 

regulated entities. 

EPA considered the recommendation 

and the Agency has provided readily 

available information on potential costs 

that could be incurred using strategies 

to meet requirements for any proposed 

exposure controls, such as engineering, 

administrative, or prescriptive controls 

(e.g., use of specialized systems, cost of 

new equipment, PPE use), or 

concentration limit, as they apply to 

each relevant COU, in the Economic 

Analysis (Ref. 6). 


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Recommendation 4. Based on SER 

comments providing diverse 

perspectives on preferences for exposure 

control technologies and methods, the 

Panel recommends that the EPA 

consider and request comment on a 

regulatory approach for those 

conditions of use where the EPA has 

confidence that exposures to PV29 can 

be effectively controlled, and what 

flexibility could be provided to 

regulated entities to incorporate the 

hierarchy of controls to reduce 

exposures so that the unreasonable risk 

is no longer present. 

EPA considered the recommendation 

and the Agency also requests comment 

on a regulatory approach for those 

conditions of use where the EPA has 

confidence that exposures to PV29 can 

be effectively controlled, and what 

flexibility could be provided to 

regulated entities to incorporate the 

hierarchy of controls to reduce 

exposures so that the unreasonable risk 

is no longer present. The Agency’s 

consideration of these points is reflected 

in the proposed and alternative 

regulatory options, as described in Unit 

IV and with additional rationale 

provided in Unit V. 

Recommendation 5. The Panel 

recommends that the EPA provide an 

overview of information reasonably 

available regarding engineering or 

administrative controls that could 

address inhalation exposures expected 

for PV29. The panel recommends that 

the EPA seek comment on state-of-theart equipment, engineering and 

administrative controls, and monitoring 

for inhalation exposures. 

EPA considered the recommendation 

and the Agency has provided an 

overview of information reasonably 

available regarding engineering that 

could address inhalation exposures 

expected for PV29 as part of the 

Economic Analysis (Ref. 6). Some 

administrative controls are mentioned 

in the Economic Analysis, such as 

training for respirator usage, and were 

incorporated into the proposed and 

alternative proposed options as 

requirements for signage for regulated 

areas and respirator fit testing. 

Additionally, the EPA requests 

comment on state-of-the-art equipment, 

engineering and administrative controls, 

and monitoring for inhalation 

exposures, including the amount of time 

needed to develop an inhalation 

exposure monitoring method or how to 

use existing monitoring methods for 

other chemicals. 

Recommendation 6. The Panel 

recommends that the EPA consider 

tailoring the applicability of 

requirements for entities that can 

demonstrate they do not use pure, dry/ 

powder PV29 as long as the 

requirements are sufficient so that PV29 

no longer presents unreasonable risk. 

EPA has considered the 

recommendation and the Agency has 

tailored the applicability of 

requirements for entities that can 

demonstrate they do not use pure, dry/ 

powder PV29 as long as the 

requirements are sufficient so that PV29 

no longer presents unreasonable risk. 

The Agency’s consideration of this point 

is reflected in the reference to and 

definition of ‘‘regulated PV29’’ in the 

proposed and alternative regulatory 

options, as described in Unit IV and 

with additional rationale provided in 

Unit V. 

Recommendation 7. The Panel 

recommends that the EPA consider, in 

accordance with the scientific standards 

and the weight of scientific evidence 

required by TSCA, the data submitted 

after publication of the final risk 

evaluation for PV29 in the development 

of risk management options. 

EPA has considered the 

recommendation and has considered, in 

accordance with the scientific standards 

and the weight of scientific evidence 

required by TSCA, the data submitted 

after publication of the final risk 

evaluation for PV29 in the development 

of risk management options. EPA 

assessed the quality of the particle size 

data in the study performed in 2020 by 

the current manufacturer of regulated 

PV29. This assessment can be found in 

the docket (Refs. 3, 24). 

B. Consideration of Alternatives in 

Deciding Whether To Prohibit or 

Substantially Restrict PV29 

Under TSCA section 6(c)(2)(C), in 

deciding whether to prohibit or restrict 

in a manner that substantially prevents 

a specific condition of use of a chemical 

substance or mixture, and in setting an 

appropriate transition period for such 

action, EPA must consider, to the extent 

practicable, whether technically and 

economically feasible alternatives that 

benefit human health or the 

environment will be reasonably 

available as a substitute when the 

proposed prohibition or other restriction 

takes effect. Because EPA is not 

proposing to prohibit or restrict in a 

manner that substantially prevents any 

conditions of use of PV29, formal 

consideration of alternatives was not 

necessary. 

VI. TSCA Section 6(c)(2) Considerations 

A. C.I. Pigment Violet 29: Health Effects 

and the Magnitude of Human Exposure 

For assessment of risks associated 

with inhalation exposures to workers for 

PV29, EPA used an analogue, carbon 

black, to estimate toxicity. EPA used an 

analogue because no data were available 

for PV29 for inhalation exposure. 

Chronic exposure to PV29 is expected to 

increase lung burden which may result 

in kinetic lung overload, a 

pharmacokinetic phenomenon, which is 

not due to the overt toxicity of the 

chemical, but rather the possibility that 

PV29 dust overwhelms the lung 

clearance mechanisms over time. The 

inhalation toxicity data on the analogue, 

carbon black, demonstrated increased 

lung burden, alveolar hyperplasia, 

inflammatory and morphological 

changes in the lower respiratory tract. 

Populations exposed to PV29 include 

individuals age 16 to 19, men and 

women of reproductive age (16 to 54 

years old), and the elderly (55+ years 

old), including pregnant women and 

individuals who do not use PV29 but 

may be indirectly exposed due to their 

proximity to the user who is directly 

handling PV29 (ONUs). EPA estimates 

that, annually, there are approximately 

between 57 and 77 workers and 78 

ONUs at 22 facilities either 

manufacturing, processing, or using 

regulated PV29 for industrial and 

commercial conditions of use (Ref. 6). 

B. C.I. Pigment Violet 29: Environmental 

Effects and the Magnitude of 

Environmental Exposure 

EPA identified and evaluated PV29 

environmental hazard data for fish, 

aquatic invertebrates, amphibians, and 

aquatic plants across acute and chronic 

exposure durations. No effects were 

observed in acute toxicity testing with 

fish, aquatic invertebrates, and aquatic 

plants up to the limit of solubility of 

PV29. As a result, no concentrations of 

concern (COC) can be calculated for this 

chemical, as it is not possible to 

dissolve enough quantities of PV29 in 

water to elicit a response in aquatic 

organisms. 

EPA determined that environmental 

exposures of PV29 for the conditions of 

use are expected to be limited as a result 

of a qualitative consideration of 

reasonably available physical and 

chemical, environmental fate, 

manufacturing and release, and 

exposure data. Considering the limited 

nature of the environmental exposures 

resulting from the conditions of use of 

PV29 and the lack of effects observed in 

the available environmental hazard 

studies, environmental concentrations 


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of PV29 are not expected to reach a level 

where adverse effects to environmental 

receptors could occur. 

C. Benefits of C.I. Pigment Violet 29 for 

Various Uses 

Leading applications for PV29 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 (Ref. 1). 

According to data collected in EPA’s 

2016 Chemical Data Reporting (CDR) 

database, 603,420 pounds of PV29 were 

manufactured in the U.S. in 2015. EPA 

has identified one domestic 

manufacturer and one importer of PV29 

in the United States (Ref. 1). 

Stakeholder feedback during SBAR 

Panel proceedings indicated that 

industry has not been able to find a 

suitable alternative for PV29, which is 

used in automotive paints and coatings 

(Ref. 3). 

D. Reasonably Ascertainable Economic 

Consequences of the Proposed Rule 

1. Likely Effect of the Rule on the 

National Economy, Small Business, 

Technological Innovation, the 

Environment, and Public Health 

With respect to the anticipated effects 

of this rule on the national economy, the 

economic impact of a regulation on the 

national economy generally only 

becomes measurable if the economic 

impact of the regulation reaches 0.25 

percent to 0.5 percent of Gross Domestic 

Product (GDP) (Ref. 25). Given the 

current GDP this is equivalent to a cost 

of $69 billion to $139 billion. Therefore, 

because EPA has estimated that the 

monetized costs of the rule to range 

from $1.6 to $1.7 million annualized 

over 15 years at a 2% discount rate, EPA 

has concluded that this action is highly 

unlikely to have any measurable effect 

on the national economy (Ref. 6). EPA 

considered the number of businesses, 

facilities, and workers that would be 

affected and the costs and benefits to 

those businesses and workers and 

society at large and did not find that 

there would be a measurable effect on 

the national economy. 

In addition, EPA considered the 

employment impacts of this proposal. 

While EPA does not have data to 

quantify employment impacts of the 

proposed rule. However, EPA expects 

the short-term and longer-term 

employment effects to be small. Of the 

approximately 50,000 small businesses 

estimated to be potentially impacted by 

this rule, greater than 99% of firms are 

estimated to have impacts less than 1% 

of revenues. Only a single firm is 

estimated to have impacts between 1 

and 3% to their firm revenues, and no 

firms are expected to have impacts 

greater than 3% to their firm revenues. 

2. Costs and Benefits of the Proposed 

Regulatory Action and of the 1 or More 

Primary Alternative Regulatory Actions 

Considered by the Administrator 

The costs and benefits that can be 

monetized for this rule are described at 

length in in the Economic Analysis (Ref. 

6). The monetized costs for this rule are 

estimated to range from $1.6 million to 

$1.7 million annualized over 15 years at 

a 2% discount rate. 

EPA considered the estimated costs to 

regulated entities as well as the cost to 

administer alternative regulatory 

actions. The primary alternative 

regulatory action is described in detail 

in Unit IV.B. The estimated annualized 

costs of the alternative regulatory action 

are $.9 million at a 2% discount rate 

over 15 years (Ref. 6). 

The proposed rule is expected to 

achieve health benefits for the American 

public. Human health hazards for 

regulated PV29 were assessed in the 

Risk Evaluation [Ref X] using carbon 

black as an analogue. Effects of carbon 

black exposure include increased lung 

burden, alveolar hyperplasia, and 

inflammatory and morphological 

changes in the lower respiratory tract. 

These endpoints are not monetizable 

themselves, however there are 

occupational studies on carbon black 

that have found significant relationships 

between inhalable carbon black dust 

exposure and respiratory effects, 

including chronic bronchitis. EPA 

estimates that the monetized benefits of 

reducing chronic bronchitis cases due to 

the proposed rule are estimated to range 

from $271 to $629 thousand annualized 

over 15 years at a 2% discount rate. The 

monetized benefits of this alternative 

regulatory action are estimated to range 

from $168 to $375 thousand annualized 

over 15 years at 2% (Ref. 6). 

Cost effectiveness of the proposed 

regulatory action and of the 1 or more 

primary alternative regulatory actions 

considered by the Administrator. Cost 

effectiveness is a method of comparing 

certain actions in terms of the expense 

per item of interest or goal. The 

proposed rule costs an estimated $1.9– 

$4.3 million per potential bronchitis 

case avoided while the alternative 

option costs an estimated $1.8–$3.9 

million per potential bronchitis case 

avoided using annualized costs for the 

2 percent discount rate. Thus, the 

alternative option has a slightly lower 

cost per case of chronic bronchitis 

avoided compared to the proposed 

option, making it the most cost-effective 

of the two options considered based on 

estimated costs and benefits. The 

primary differences between the 

proposal and alternative option are that 

the alternative would require 

engineering controls, such as HEPA 

filters, to control the regulated PV29 air 

concentration in addition to PPE and 

monitoring requirements to measure air 

concentrations for respirable dust. 

However, the costs of engineering 

controls are not monetized in the 

Economic Analysis. 

3. Request for Comments Regarding the 

Reasonably Ascertainable Economic 

Consequences of the Proposed Rule 

EPA requests comment on its analyses 

of the number of affected firms, 

facilities, and occupational users and 

non-users. EPA requests comment on 

current PPE practices within affected 

facilities using regulated PV29 in any of 

the conditions of use. Finally, EPA 

requests comment on the costs firms 

would incur as a result of the proposed 

rule, as well as information that the 

Agency could use to improve these 

estimates. 

VII. TSCA Section 9 Analysis and 

Section 26 Considerations 

A. TSCA Section 9(a) Analysis 

TSCA section 9(a) provides that, if the 

Administrator determines, in the 

Administrator’s discretion, that an 

unreasonable risk may be prevented or 

reduced to a sufficient extent by an 

action taken under a Federal law not 

administered by EPA, the Administrator 

must submit a report to the agency 

administering that other law that 

describes the risk and the activities that 

present such risk. TSCA section 9(a) 

describes additional procedures and 

requirements to be followed by EPA and 

the other Federal agency following 

submission of any such report. As 

discussed in this unit, for this proposed 

rule, the Administrator proposes to 

exercise his discretion not to determine 

that the unreasonable risk from PV29 

under the conditions of use may be 

prevented or reduced to a sufficient 

extent by an action taken under a 

Federal law not administered by EPA. 

TSCA section 9(d) instructs the 

Administrator to consult and coordinate 

TSCA activities with other Federal 

agencies for the purpose of achieving 

the maximum enforcement of TSCA 

while imposing the least burden of 

duplicative requirements. For this 


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proposed rule, EPA has coordinated 

with appropriate Federal executive 

departments and agencies, to, among 

other things, identify their respective 

authorities, jurisdictions, and existing 

laws with regard to risk evaluation and 

risk management of PV29, which are 

summarized in this Unit, and in Unit II. 

B. 

OSHA requires that employers 

provide safe and healthful working 

conditions by setting and enforcing 

standards and by providing training, 

outreach, education, and assistance. 

Gaps exist between OSHA’s authority to 

set workplace standards under the OSH 

Act and EPA’s obligations under TSCA 

section 6 to eliminate unreasonable risk 

presented by chemical substances under 

the conditions of use. Health standards 

issued under section 6(b)(5) of the OSH 

Act must reduce significant risk only 

‘‘to the extent feasible.’’ 29 U.S.C. 

655(b)(5). To set PELs for chemical 

exposure, OSHA must first establish 

that the new standards are economically 

and technologically feasible (79 FR 

61384, 61387, Oct. 10, 2014). OSHA also 

does not have direct authority over selfemployed individuals and public sector 

workers who are not covered by a State 

Plan under 29 U.S.C. 667. 

The 2016 amendments to TSCA 

altered both the manner of identifying 

unreasonable risk and EPA’s authority 

to address unreasonable risk, such that 

risk management is increasingly distinct 

from provisions of the OSH Act. EPA 

risk evaluations under TSCA section 

6(b) must determine, without 

consideration of costs or other nonrisk 

factors, whether an unreasonable risk of 

injury to health or the environment is 

presented, including an unreasonable 

risk to a relevant potentially exposed or 

susceptible subpopulation. In a TSCA 

section 6 risk management rule, 

following such an unreasonable risk 

determination, EPA must apply risk 

management requirements to the extent 

necessary so that the chemical no longer 

presents unreasonable risk and only 

consider costs and benefits of the 

regulatory action to the extent 

practicable, 15 U.S.C. 2605(a), (c)(2). 

EPA’s substantive burden under TSCA 

section 6(a) is to apply requirements to 

the extent necessary so that the 

chemical substance no longer presents 

the unreasonable risk that was 

determined in accordance with TSCA 

section 6(b)(4)(A) without consideration 

of cost or other nonrisk factors. 

EPA therefore concludes that TSCA is 

the only regulatory authority able to 

prevent or reduce unreasonable risk of 

PV29 to a sufficient extent across the 

conditions of use, exposures, and 

populations of concern. The timeframe 

and any exposure reduction as a result 

of updating OSHA regulations cannot be 

estimated, while TSCA imposes a much 

more accelerated statutory timeframe for 

proposing and finalizing requirements 

to address unreasonable risk. Further, 

there are key differences between the 

finding requirements of TSCA and those 

of the OSH Act. For these reasons, in the 

Administrator’s discretion, the 

Administrator has analyzed this issue 

and does not determine that 

unreasonable risk presented by PV29 

may be prevented or reduced to a 

sufficient extent by an action taken 

under a Federal law not administered by 

EPA. 

B. TSCA Section 9(b) Analysis 

If EPA determines that actions under 

other Federal laws administered in 

whole or in part by EPA could eliminate 

or sufficiently reduce a risk to health or 

the environment, TSCA section 9(b) 

instructs EPA to use these other 

authorities to protect against that risk 

unless the Administrator determines, in 

the Administrator’s discretion, that it is 

in the public interest to protect against 

such risk under TSCA. In making such 

a public interest finding, TSCA section 

9(b)(2) requires EPA to consider, based 

on the reasonably available information, 

all relevant aspects of the risk and a 

comparison of the estimated costs and 

efficiencies of the action to be taken 

under TSCA and an action to be taken 

under another law administered by the 

Agency to protect against such risk. 

The primary exposures and 

unreasonable risk to workers and 

occupational non-users would be 

addressed by EPA’s proposed 

prohibitions and restrictions under 

TSCA section 6(a). There are no EPA 

statutes or other regulations for PV29 

that would result in reduced exposure 

to PV29 in occupational settings. EPA 

therefore concludes that TSCA is the 

most appropriate regulatory authority 

able to prevent or reduce risks of PV29 

to a sufficient extent across the 

conditions of use, exposures, and 

populations of concern. 

For these reasons, the Administrator 

does not determine that unreasonable 

risk from PV29 under its conditions of 

use, as evaluated in the 2021 Risk 

Evaluation for C.I. Pigment Violet 29, 

could be eliminated or reduced to a 

sufficient extent by actions taken under 

other Federal laws administered in 

whole or in part by EPA. 

C. TSCA Section 26 Considerations 

In accordance with TSCA section 

26(h), EPA has used scientific 

information, technical procedures, 

measures, methods, protocols, 

methodologies, and models consistent 

with the best available science. As in 

the case of the unreasonable risk 

determination, risk management 

decisions for this proposed rule, as 

discussed in Units III.B.3. and V., were 

based on a risk evaluation that was 

subject to public comment and 

independent, expert peer review, and 

was developed in a manner consistent 

with the best available science and 

based on the weight of the scientific 

evidence as required by TSCA sections 

26(h) and (i) and 40 CFR 702.43 and 

702.45. 

The extent to which the various 

information, procedures, measures, 

methods, protocols, methodologies, or 

models, as applicable, used in EPA’s 

decisions have been subject to 

independent verification or peer review 

is adequate to justify their use, 

collectively, in the record for this rule. 

Additional information on the peer 

review and public comment process, 

such as the peer review plan, the peer 

review report, and the Agency’s 

response to public comments, can be 

found at EPA’s risk evaluation dockets 

(Docket ID No. EPA–HQ–OPPT–2016– 

0725 and EPA–HQ–OPPT–2018–0604). 

VIII. Requests for Comment 

While EPA is requesting public 

comment on all aspects of this proposal, 

the Agency is soliciting feedback from 

the public on specific issues throughout 

this proposed rule. This section 

summarizes those specific requests for 

comments. 

1. EPA is requesting public comment 

on the proposed regulatory action and 

alternative regulatory action, including 

whether EPA should have more 

prescriptive requirements for the 

cleaning plan. (Unit IV.) 

2. EPA is requesting comment on 

whether to require owners or operators 

to provide additional workplace training 

related to PV29 where regulated PV29 is 

present. (Unit IV.) 

3. EPA is requesting public comment 

on EPA’s proposal to not grant a TSCA 

section 6(g) exemption. 

4. EPA requests public comments 

regarding the number of small 

businesses subject to the rule and the 

potential impacts of the rule on these 

small businesses. 

5. EPA is requesting comment on the 

proposed rule’s rationale, including the 

definition of regulated PV29. (Unit V.) 

6. EPA requests comment on whether 

EPA should promulgate definitions for 

those conditions of use evaluated in the 

2021 Risk Evaluation for C.I. Pigment 

Violet 29, and, if so, whether the 

descriptions in this unit are consistent 

with the conditions of use evaluated in 


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the 2021 Risk Evaluation for C.I. 

Pigment Violet 29 and whether they 

provide a sufficient level of detail to 

improve the clarity and readability of 

the regulation if EPA were to 

promulgate a regulation that contains a 

list of all prohibited or otherwise 

regulated industrial and commercial 

conditions of use. (Unit III.) 

7. EPA is soliciting comment on 

whether six months is a reasonable 

timeframe to implement respiratory 

protection requirements or if a different 

timeframe is needed. (Unit IV.) 

8. EPA is requesting comment on 

whether there should be a requirement 

for a minimum service life of nonpowered air-purifying respirators such 

as the requirements found in OSHA’s 

General Industry Standard for Benzene 

(29 CFR 1910.1028(g)(3)(D)). (Unit IV.) 

9. EPA will consider compliance 

timeframes that may be substantially 

longer or shorter than the proposed 

timeframes for owners or operators for 

procedural adjustments needed to 

comply with the requirements outlined 

in this unit (Unit IV.) and is requesting 

comment on the feasibility of the 

proposed compliance timeframes, as 

well as longer or shorter timeframes. 

(Unit IV.) 

10. Per the SBAR Panel’s 

recommendation, EPA is requesting 

comment on this approach, specifically 

how to mitigate the exposure to dry 

powder PV29, by entities that could, 

based on demonstrated ability through 

recordkeeping and utilization of a 

combination of controls (including 

engineering controls, administrative 

controls, and PPE requirements), 

eliminate inhalation exposure to PV29 

to address the unreasonable risk. (Unit 

V.) 

11. For EPA’s primary alternative 

regulatory action, described in Unit 

IV.B., EPA is requesting comment on 

whether any of the uses the Agency is 

proposing to implement respiratory 

protection requirements for could be 

better served by requiring exposure 

controls in accordance with the 

hierarchy of controls, including but not 

limited to engineering controls in 

tandem with respiratory protection. 

(Unit V.) 

12. Per the SBAR Panel’s 

recommendation, EPA requests 

comment on reasonable compliance 

timeframes for small businesses, with 

emphasis on comment about how to 

provide longer compliance timeframes 

for transitioning to uses requiring 

reformulation. (Unit V.) 

13. Per the SBAR Panel’s 

recommendation, EPA requests 

comment on a regulatory approach for 

those conditions of use where the EPA 

has confidence that exposures to PV29 

can be effectively controlled, and what 

flexibility could be provided to 

regulated entities to incorporate the 

hierarchy of controls to reduce 

exposures so that the unreasonable risk 

is no longer present. (Unit V.) 

14. Per the SBAR Panel’s 

recommendation, EPA requests 

comment on state-of-the-art equipment, 

engineering and administrative controls, 

and monitoring for inhalation 

exposures, including the amount of time 

needed to develop an inhalation 

exposure monitoring method or how to 

use existing monitoring methods for 

other chemicals. (Unit V.) 

15. EPA requests comment on its 

analyses of the number of affected firms, 

facilities, and occupational users and 

non-users. (Unit VI.) 

16. EPA requests comment on current 

PPE practices within affected facilities 

using regulated PV29 in any of the 

conditions of use. (Unit VI.) 

17. EPA requests comment on the 

costs firms would incur as a result of the 

proposed rule, as well as information 

that the Agency could use to improve 

these estimates. (Unit VI.) 

18. EPA is requesting public comment 

on the interpretations of risk when it is 

in other forms including bound in a 

matrix like paint or liquid, and if uses, 

e.g. aerosol spraying, sanding or 

grinding dry paint, could render PV29 

biologically available or possibly pose 

an inhalation exposure risk. (Unit II.) 

IX. 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 technical person listed under FOR

FURTHER INFORMATION CONTACT. 

1. EPA. Risk Evaluation for C.I. Pigment 

Violet 29 (Anthra[2,1,9-def:6,5,10- 

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

tetrone). EPA Document #740–R–18–015. 

January 2021. 

2. EPA. Colour Index Pigment Violet 29 

(PV29); Revision to the Toxic Substances 

Control Act (TSCA) Risk Determination. 

September 2022. 

3. Small Business Advocacy Review Panel. 

Small Business Advocacy Review Panel 

on EPA’s Planned Proposed Rule under 

the Toxic Substances Control Act (TSCA) 

Section 6(a) for C.I. Pigment Violet 29 

(PV29). September 14, 2023. 

4. California Office of Environmental Health 

Hazard Assessment. Carbon Black 

Proposition 65 Listing Notice. https://

oehha.ca.gov/proposition-65/crnr/ 

chemical-listed-effective-february-21- 

2003-known-state-california-causecancer (accessed November 5, 2024). 

5. EPA. Memorandum for ECRAD Response 

to CPMA Comments Following Small 

Business Advocacy Review Panel 

Outreach Meeting on Proposed PV29 

Risk Management Rulemaking. March 

20, 2024. 

6 EPA. C.I. Pigment Violet 29 (PV29); 

Regulation Under the Toxic Substances 

Control Act (TSCA); Economic Analysis. 

December 2024. 

7. Executive Order 13985. Advancing Racial 

Equity and Support for Underserved 

Communities Through the Federal 

Government. Federal Register (86 FR 

7009, January 25, 2021). 

8. 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). 

9. Executive Order 14008. Tackling the 

Climate Crisis at Home and Abroad. 

Federal Register (86 FR 7619, February 

1, 2021). 

10. EPA. Colour Index Pigment Violet 29 

(PV29): Revision to Toxic Substances 

Control Act (TSCA) Risk Determination 

Response to Public Comments. August 

2022. 

11. EPA. Stakeholder Meeting List for 

Rulemaking for C.I. Pigment Violet 29 

under TSCA Section 6(a). 

12. 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), Response to Support the Final 

Risk Evaluation of C.I. Pigment Violet 29. 

January 2021. 

13. EPA. Federalism Consultation on 

Forthcoming Proposed Rulemakings 

under TSCA Section 6(a) for Asbestos, 

Part 1: Chrysotile Asbestos and C.I. 

Pigment Violet 29. May 13, 2021. 

14. EPA. Tribal Consultations on Risk 

Management Rulemakings for Asbestos, 

Part 1: Chrysotile Asbestos and C.I. 

Pigment Violet 29. May 24, 2021 and 

June 3, 2021. 

15. EPA. Environmental Justice Consultations 

Risk Management Rulemakings for 

Asbestos, Part 1: Chrysotile Asbestos and 

C.I. Pigment Violet 29. June 1, 2021 and 

June 9, 2021. 

16. EPA. Public Webinar on Asbestos, Part 1: 

Chrysotile Asbestos and C.I. Pigment 

Violet 29: Risk Evaluation and Risk 

Management under TSCA Section 6. 

February 23, 2021. 

17. EPA. Small Business Administration 

Small Business Environmental 

Roundtable Risk Evaluation and Risk 

Management under TSCA Section 6 for 

C.I. Pigment Violet 29. February 26, 

2021. 

18. EPA. EPA’s Policy on Children’s Health. 

October 5, 2021. https://www.epa.gov/ 

children/childrens-health-policy-andplan#A1. 

19. EPA. Final Risk Evaluation for C.I. 

Pigment Violet 29 (PV29) Supplemental 


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File: Information Received from 

Manufacturing Stakeholders. January 

2021. 

20. EPA. Chemical Risk Evaluation Meeting 

with Sun Chemical Corporation, Color 

Pigments Manufacturers Association and 

EPA to Discuss the Downstream 

Processors of C.I. Pigment Violet 29 

(PV29). October 16, 2020. 

21. Raleigh Davis; American Coatings 

Association. Comments to the U.S. 

Environmental Protection Agency in 

Response to the TSCA Chemical Use 

Dossiers on Pigment Violet 29. March 15, 

2017. 

22. David Wawer; Color Pigment 

Manufacturers Association, Inc. 

Comment to the EPA about the 

Toxicological Properties, Chemical Use 

(and Other) Information Relevant to 

EPA’s Risk Evaluation of C.I. Pigment 

Violet 29. March 13, 2017. 

23. National Institute for Occupational Safety 

and Health. Hierarchy of Controls. Page 

last reviewed: April 10, 2024. https://

www.cdc.gov/niosh/hierarchy-ofcontrols/about/. 

24. EPA. ECRAD Review of Ramboll’s 

Airborne Particle Size Characterization 

of C.I. Pigment Violet 29 (PV29) Study 

and Risk Management Related-Issues. 

March 13, 2024. 

25. Office of Management and Budget. 

Memorandum for the Heads of Executive 

Departments and Agencies. Guidance for 

Implementing Title II of S. 1. March 31, 

1995. https://www.whitehouse.gov/wpcontent/uploads/legacy_drupal_files/ 

omb/memoranda/1995-1998/m95- 

09.pdf. 

26. EPA. Supporting Statement for an 

Information Collection Request (ICR) 

Under the Paperwork Reduction Act 

(PRA); Regulation of C.I. Pigment Violet 

29 under TSCA Section 6(a) (Proposed 

Rule; RIN 2070–AK87). December 2024. 

X. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a significant 

regulatory action as defined in 

Executive Order 12866 (58 FR 51735, 

October 4, 1993), as amended by 

Executive Order 14094 (88 FR 21879, 

April 11, 2023), and was therefore not 

subject to a requirement for Executive 

Order 12866 review. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this proposed rule have been 

submitted to OMB for review and 

comment under the PRA, 44 U.S.C. 3501 

et seq. The Information Collection 

Request (ICR) document that EPA 

prepared has been assigned EPA ICR 

No. 7797.01 (Ref. 26). You can find a 

copy of the ICR in the docket, and it is 

briefly summarized here. 

The information collection 

requirements contained in the proposed 

rule are: 

• The preparation and retention of 

records related to respiratory protection 

requirements in accordance with 

proposed 40 CFR 751.909(b)(2); 

• The preparation and retention of 

records related to the equipment and 

area cleaning in accordance with 

proposed 40 CFR 751.909(b)(1); 

• Third-party downstream 

notifications in accordance with 

proposed 40 CFR 751.907 from 

companies that ship PV29 to companies 

downstream in the supply chain 

through the SDS to communicate the 

proposed prohibitions; and 

• The preparation and retention of 

related records in accordance with 

proposed 40 CFR 751.909, including 

ordinary business records, such as 

invoices and bills-of-lading related to 

the continued distribution of PV29 in 

commerce. 

Respondents/affected entities: 

Manufacturers (including importers), 

processors, distributors, and industrial 

and commercial users of C.I. Pigment 

Violet 29. See Unit I.A. and the ICR for 

more details. 

Respondent’s obligation to respond: 

Mandatory (15 U.S.C. 2605). 

Estimated number of respondents: 

49,670. 

Frequency of response: On occasion. 

Total estimated burden: 16,976 hours 

(per year). Burden is defined at 5 CFR 

1320.3(b). 

Total estimated cost: $1,646,584 (per 

year), includes $200 annualized capital 

or operation and maintenance costs. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. After display in the 

Federal Register when approved, the 

OMB control numbers for EPA 

regulations in 40 CFR are listed in 40 

CFR part 9 and displayed on the form 

and instructions or collection portal, as 

applicable. 

Submit your comments on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates and any suggested methods 

for minimizing respondent burden to 

the EPA using the docket identified at 

the beginning of this rule. EPA will 

respond to any ICR-related comments in 

the final rule. You may also send your 

ICR-related comments to OMB’s Office 

of Information and Regulatory Affairs 

using the interface at https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. OMB must 

receive comments no later than 

February 13, 2025. 

C. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA, 5 U.S.C. 601 et seq. The 

small entities subject to the 

requirements of this action are small 

businesses that manufacture/import, 

process or use the chemical subject to 

this proposed rule. The estimated 

annualized costs of this rule are less 

than $2 million at a 2% discount over 

15 years. Only 22 firms are estimated to 

incur compliance costs associated with 

rule requirements and five of those are 

small businesses, however EPA expects 

that four would be impacted only at less 

than 1% of revenues and only a single 

firm would be impacted at between 1% 

and 3% of revenues. Approximately 

50,000 small businesses firms are 

expected to only incur costs associated 

with becoming familiar with the 

proposed requirements and determining 

that they would not subject to the 

proposed requirements. EPA does not 

expect that the costs associated with 

simply reading and becoming familiar 

with the proposed requirements would 

result in direct costs at 1 percent of 

annual revenues or greater. Details of 

this analysis are presented in the 

Economic Analysis (Ref. 6). 

Although not required by the RFA to 

convene a Small Business Advocacy 

Review (SBAR) Panel because the EPA 

has now determined that this proposal 

would not have a significant economic 

impact on a substantial number of small 

entities, the EPA originally convened a 

panel to obtain advice and 

recommendations from small entity 

representatives potentially subject to 

this rule’s requirements. A copy of the 

SBAR Panel Report is included in the 

docket for this rulemaking. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain an 

unfunded mandate of $100 million (in 

1995 dollars and adjusted annually for 

inflation) or more as described in 

UMRA, 2 U.S.C. 1531–1538, and does 

not significantly or uniquely affect small 

governments. The costs involved in this 

action are estimated not to exceed $183 

million in 2023$ ($100 million in 

1995$, adjusted for inflation using the 


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3128 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Proposed Rules 

GDP implicit price deflator) or more in 

any one year. 

E. Executive Order 13132: Federalism 

EPA has concluded that this action 

has federalism implications, as specified 

in Executive Order 131312 (64 FR 

43255, August 10, 1999), because 

regulation under TSCA section 6(a) may 

preempt State law. As set forth in TSCA 

section 18(a)(1)(B), the issuance of rules 

under TSCA section 6(a) to address the 

unreasonable risk presented by a 

chemical substance or mixture has the 

potential to trigger preemption of State 

laws, criminal penalties, or 

administrative action by a State or 

political subdivison of a State that: (1) 

is applicable to the same chemical 

substance or mixture as the rule under 

TSCA section 6(a); and (2) is to prohibit 

or otherwise restrict the manufacture, 

processing, or distribution in commerce 

or use of that same chemical. TSCA 

section 18(c)(3) applies that preemption 

only to the hazards, exposures, risks, 

and uses or conditions of use of such 

chemical included in the final TSCA 

section 6(a) rule. 

EPA provides the following 

federalism summary impact statement. 

The Agency consulted with State and 

local officials early in the process of 

developing the proposed action to 

permit them to have meaningful and 

timely input into its development. This 

included a consultation meeting on May 

13, 2021. EPA invited the following 

national organizations representing 

State and local elected officials to this 

meeting: National Association of 

Attorneys General, Western States Water 

Council, National Water Resources 

Association, Association of State 

Drinking Water Administrators, 

Association of Clean Water 

Administrators, Association of 

Metropolitan Water Agencies, American 

Water Works Association, National 

Governors Association; National 

Conference of State Legislatures, 

National League of Cities, U.S. 

Conference of Mayors, National 

Association of Counties, County 

Executives of America, and 

Environmental Council of States. A 

summary of the meeting with these 

organizations, including the views that 

they expressed, is available in the 

docket (Ref. 13). EPA provided an 

opportunity for these organizations to 

provide follow-up comments in writing 

but did not receive any such comments. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). This rulemaking would not have 

substantial direct effects on tribal 

governments because PV29 is not 

manufactured, processed, or distributed 

in commerce by tribes and would not 

impose substantial direct compliance 

costs on tribal governments. Thus, 

Executive Order 13175 does not apply 

to this action. 

Notwithstanding the lack of Tribal 

implications as specified by Executive 

Order 13175, EPA consulted with Tribal 

officials during the development of this 

action, consistent with the EPA Policy 

on Consultation and Coordination with 

Indian Tribes, which EPA applies more 

broadly than Executive Order 13175. 

The Agency held a Tribal consultation 

from June 3, 2021, to August 20, 2021, 

with meetings on May 24 and June 3, 

2021. Tribal officials were given the 

opportunity to meaningfully interact 

with EPA risk managers concerning the 

current status of risk management. 

During the consultation, EPA discussed 

risk management under TSCA section 

6(a), findings from the 2021 Risk 

Evaluation for C.I. Pigment Violet 29, 

types of information that would be 

helpful to inform risk management, 

principles for transparency during the 

risk management process, and types of 

information EPA is seeking from tribes 

(Ref. 14). EPA received no written 

comments as part of this consultation. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

Executive Order 13045 (62 FR 19885, 

April 23, 1997) directs Federal agencies 

to include an evaluation of the health 

and safety effects of the planned 

regulation on children in Federal health 

and safety standards and explain why 

the regulation is preferable to 

potentially effective and reasonably 

feasible alternatives. This action is not 

subject to Executive Order 13045 

because it is not a significant regulatory 

action under section 3(f)(1) of Executive 

Order 12866, and because the EPA does 

not believe the environmental health or 

safety risks addressed by this action 

present a disproportionate risk to 

children. Accordingly, we have 

evaluated associated health impacts of 

PV29 exposure on children and adults 

of reproductive age. The effects related 

to the endpoint used for PV29 risk 

evaluation were alveolar hyperplasia, 

inflammatory, and morphological 

changes in the lungs, which are not 

associated with disproportionate effects 

to children. EPA did not find evidence 

of reproductive and developmental 

toxicity as a result of exposure to PV29. 

This action’s health and risk 

assessments and impacts on both 

children and adults from occupational 

use from inhalation and dermal 

exposures are described in Units III.A.3, 

III.B.3, VI.A., and the 2021 Risk 

Evaluation for C.I. Pigment Violet 29 

(Ref. 1). However, EPA’s Policy on 

Children’s Health applies to this action. 

Information on how the Policy was 

applied is available in Unit III.A.3. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001) because it is not a significant 

regulatory action under Executive Order 

12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This action does not involve technical 

standards under the NTTAA section 

12(d), 15 U.S.C. 272. 

J. Executive Orders 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations and Executive 

Order 14096: Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All 

EPA believes that the human health 

and environmental conditions that exist 

prior to this action result in or have the 

potential to result in disproportionate 

and adverse human health or 

environmental effects on communities 

with EJ concerns in accordance with 

Executive Order 14096 (88 FR 25251, 

April 26, 2023) (building on and 

supplementing Executive Order 12898 

(59 FR 7629, February 16, 1994)). As 

described more fully in the Economic 

Analysis for this rulemaking (Ref. 6), 

EPA conducted an analysis to 

characterize the baseline conditions 

faced by workers affected by the 

proposed regulation to identify the 

potential for disproportionate impacts 

on communities with affected by the 

proposed regulatory option under 

current conditions, before the regulation 

would go into effect. The analysis drew 

on publicly available data provided by 

EPA and the U.S. Census Bureau, 

including data from the American 

Community Survey (ACS) and the 

Quarterly Workforce Indicators (QWI). 

The baseline characterization suggests 

that workers in affected industries are 

more likely to be people of color than 

the general population in affected areas 

(Ref. 6). Therefore, based on reasonably 

available information, EPA determined 

that there are potential environmental 

justice concerns in communities 


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surrounding facilities subject to this 

regulation (Ref. 6). 

EPA believes that it is not practicable 

to assess whether this action is likely to 

reduce or result in new disproportionate 

and adverse effects on communities 

with environmental justice concerns. 

While this proposed regulatory action 

applies requirements to the extent 

necessary so that PV29 no longer 

presents an unreasonable risk, EPA is 

not able to quantify the distribution of 

the change in risk for affected 

populations. Data limitations that 

prevent EPA from conducting a more 

comprehensive analysis are summarized 

in the Economic Analysis (Ref. 6). 

EPA additionally identified and 

addressed potential EJ concerns by 

conducting outreach to advocates of 

communities that might be subject to 

disproportionate exposure to PV29. On 

June 1, 2021, and June 9, 2021, EPA 

held public meetings as part of this 

consultation (Ref. 15). See also Unit II.D. 

These meetings were held pursuant to 

Executive Order 12898 and Executive 

Order 14008, Tackling the Climate 

Crisis at Home and Abroad (86 FR 7619, 

February 1, 2021). EPA received no 

written comments following the EJ 

meetings, in addition to oral comments 

provided during the consultations (Refs. 

13, 14, 15). 

The information supporting this 

Executive Order review is contained in 

Unit II.D., as well as in the Economic 

Analysis (Ref. 6). EPA’s presentations, a 

summary of EPA’s presentation and 

public comments made, and fact sheets 

for the EJ consultations related to this 

rulemaking are available at https://

www.epa.gov/assessing-and-managingchemicals-under-tsca/materials-june2021-environmental-justiceconsultations. These materials are also 

available in the docket for this 

rulemaking. 

List of Subjects in 40 CFR Part 751 

Environmental protection, Chemicals, 

Export notification, Hazardous 

substances, Import certification, 

reporting and recordkeeping. 

Michael S. Regan, 

Administrator. 

Therefore, for the reasons stated in the 

preamble, EPA proposes to amend 40 

CFR part 751 as follows: 

PART 751–REGULATION OF CERTAIN 

CHEMICAL SUBSTANCES AND 

MIXTURES UNDER SECTION 6 OF THE 

TOXIC SUBSTANCES CONTROL ACT 

■ 1. The authority citation for part 751 

continues to read as follows: 

Authority: 15 U.S.C. 2605, 15 U.S.C. 

2625(l)(4). 

■ 2. Add new Subpart J to read as 

follows: 

Subpart J—Color Index Pigment Violet 

29 

Sec. 

751.901 General. 

751.903 Definitions. 

751.905 Workplace requirements. 

751.907 Labeling and downstream 

notification. 

751.909 Recordkeeping requirements. 

§ 751.901 General. 

This Subpart sets certain 

requirements on the manufacture 

(including import), processing, 

distribution in commerce, use, and 

disposal of Color Index Pigment Violet 

29 (CASRN 81–33–4), also referred to as 

PV29, to prevent unreasonable risk of 

injury to health. 

§ 751.903 Definitions. 

In addition to the definitions that 

apply to this part established in § 751.5, 

the following definitions apply to this 

subpart: 

PV29 regulated area means an area 

where a regulated PV29 container is 

open or in use, an area where 

equipment containing regulated PV29 is 

in use or has not yet been cleaned, or 

an area where cleaning activities are 

occurring. 

Regulated PV29 means neat PV29 in 

a dry powder form or in dry powder 

form when mixed with other types of 

dry powder pigments. 

Residue means crumbly, powdery, or 

otherwise particulate material that can 

be dusted or swabbed off a surface. 

§ 751.905 Workplace requirements. 

(a) Applicability. The provisions of 

this section apply to workplaces 

engaged in the following conditions of 

use of regulated PV29: 

(1) Domestic manufacture. 

(2) Import. 

(3) Processing: Incorporation into 

formulation, mixture, or reaction 

products in paints and coatings. 

(4) Processing: Incorporation into 

formulation, mixture, or reaction 

products in plastic and rubber products. 

(5) Processing: intermediate in the 

creation or adjustment of color of other 

perylene pigments. 

(6) Processing: recycling. 

(7) Industrial and commercial use in 

automobile paints and coatings (original 

equipment manufacturing and 

refinishing). 

(8) Industrial and commercial use in 

coatings and basecoats for paints and 

coatings. 

(9) Industrial and commercial use in 

merchant ink for commercial printing. 

(10) Disposal. 

(b) PV29 regulated area. (1) Beginning 

[DATE 180 DAYS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], the 

owner or operator must establish, 

maintain, and demarcate a PV29 

regulated areas where exposure to 

regulated PV29 can reasonably be 

expected to occur. 

(2) The owner or operator must limit 

access to PV29 regulated areas to 

authorized persons. 

(3) The owner or operator must 

demarcate PV29 regulated areas from 

the rest of the workplace in a manner 

that adequately establishes and alerts 

persons to the boundaries of the area 

and minimizes the number of 

authorized persons exposed to regulated 

PV29 within the PV29 regulated area. 

(4) The owner or operator must 

supply a respirator that complies with 

the requirements of paragraph (c) of this 

section and must ensure that all persons 

within the PV29 regulated area are using 

the provided respirators whenever 

exposure to regulated PV29 can 

reasonably be expected to occur. 

(5) An owner or operator who has 

established a PV29 regulated area as 

required by paragraph (b)(1) of this 

section where regulated PV29 exposure 

can reasonably be expected to occur 

only on certain days (for example, 

because of work or process schedule) 

must have persons use respirators in 

that regulated area on those days. 

(6) The owner or operator must ensure 

that, within a PV29 regulated area, 

persons do not engage in non-work 

activities which may increase regulated 

PV29 exposure. 

(7) The owner or operator must ensure 

that while persons are wearing 

respirators in the PV29 regulated area, 

they do not engage in activities which 

interfere with respirator seal or 

performance. 

(c) Respiratory protection. (1) 

Beginning [DATE 180 DAYS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], owners and operators must 

supply a respirator selected in 

accordance with this section and 29 

CFR 1910.134(a) through (l), with the 

exception of paragraphs (a)(1) and (d) of 

that section, to each potentially exposed 

person. Owners and operators must 

ensure that all potentially exposed 

persons are using the provided 

respirators whenever regulated PV29 

exposures can reasonably be expected to 

occur, meaning in any PV29 regulated 

area. For purposes of this paragraph: 

(i) Any provision applying to 

‘‘employee’’ in 29 CFR 1910.134 also 


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applies equally to potentially exposed 

persons; and 

(ii) Any provision applying to 

‘‘employer’’ in 29 CFR 1910.134 also 

applies equally to any owner or operator 

for the regulated area. 

(2) Respiratory protection that is of 

safe design and construction for the 

work to be performed must be provided, 

used, and maintained in a sanitary, 

reliable, and undamaged condition. 

Owners and operators must select 

respiratory protection that properly fits 

each affected person and communicate 

respiratory protection selections to each 

affected person. 

(i) Owners or operators must select 

and provide to potentially exposed 

persons appropriate respirators as 

follows: 

(A) If there is no regulated PV29 

expected to be present in an area: no 

respiratory protection is required. 

(B) If there is regulated PV29 present 

or expected to be in an area, meaning 

that a regulated PV29 container is open 

or in use; equipment containing 

regulated PV29 is in use or has not yet 

been cleaned; the area where equipment 

for regulated PV29 is used has not yet 

been cleaned since equipment usage has 

ceased; or cleaning activities are 

occurring: Any NIOSH-certified halfmask power air-purifying respirator; any 

NIOSH-certified half-mask supplied-air 

respirator or airline respirator in 

continuous flow mode or pressuredemand or other positive pressure 

mode; any NIOSH-certified full 

facepiece air-purifying respirator; any 

NIOSH-certified full facepiece supplied 

air respirator or airline respirator in 

demand mode; any NIOSH-certified full 

facepiece self-contained breathing 

apparatus in demand mode; or any 

NIOSH-certified helmet/hood selfcontained breathing apparatus in 

demand mode (APF 50). Negativepressure respirators are acceptable for 

use if they meet the requirements stated 

in this paragraph. 

(ii) The respiratory protection 

requirements in paragraph (c)(2)(i) of 

this section represent the minimum 

respiratory protection requirements, 

such that any respirator affording a 

higher degree of protection than the 

required respirator may be used. 

(iii) When a potentially exposed 

person requires the use of a respirator 

and cannot use a negative-pressure 

respirator, the owner or operator must 

provide that person with a respirator 

that has less breathing resistance than 

the negative-pressure respirator, such as 

a powered air-purifying respirator or 

supplied-air respirator, when the person 

is able to use it and if it provides the 

person with adequate protection. 

(d) Equipment and area cleaning. (1) 

Owners or operators must ensure that 

any equipment and area where 

regulated PV29 has been manufactured, 

processed, used, or disposed is cleaned 

in accordance with a written cleaning 

plan established beginning on [DATE 

180 DAYS AFTER DATE OF 

PUBLICATION OF FINAL RULE IN 

THE FEDERAL REGISTER]. The exact 

cleaning method, materials, and 

procedure may be determined by the 

owner or operator and must meet the 

requirements outlined in paragraph 

(d)(2) of this section. 

(2) Owners or operators must meet the 

following requirements as part of the 

equipment and area cleaning: 

(i) Equipment and the area in which 

the equipment is housed must be 

cleaned within 24 hours after regulated 

PV29 has been manufactured, 

processed, used, or disposed. 

(ii) Surfaces of the equipment that 

have contact with regulated PV29 as 

part of operation and the area where the 

equipment is located must be free of 

residue. This requirement includes 

ensuring that no residue is left on 

surfaces in the area, such as the outer 

housing of equipment and places where 

dust-like particles typically settle, such 

as the floor; for example, a wet, white 

cloth, swab, or other similar cleaning 

fabric will not have visible color after 

contact with the surface. 

(iii) The cleaning plan must describe 

the cleaning methods, materials, and 

procedures to be used, as well as the 

procedure to be used to assess the 

effectiveness of the cleaning activities, 

as determined by the owner or operator, 

to meet the requirements of this section. 

(iv) The owner or operator must 

ensure that each potentially exposed 

person is instructed on the requirements 

of the regulated PV29 cleaning plan 

prior to performing work related to 

implementation of the regulated PV29 

cleaning plan. 

(v) The cleaning plan must be 

documented in the facility with records 

easily accessible for review and 

reference by potentially exposed 

persons and regulatory officials. Records 

include a copy of the cleaning plan, 

implementation records required under 

§ 751.909(b)(1), and documentation that 

instruction has been provided to 

potentially exposed persons whose job 

function includes cleaning plan 

implementation or whose job function 

requires them to be present in a 

regulated area where a cleaning plan 

could be executed. 

§ 751.907 Labeling and downstream 

notification. 

(a) Beginning on [DATE 180 DAYS 

AFTER DATE OF PUBLICATION OF 

FINAL RULE IN THE FEDERAL 

REGISTER], each person who 

manufactures (including imports), 

processes, and distributes in commerce 

regulated PV29 for any use must, prior 

to or concurrent with the shipment, 

notify persons to whom regulated PV29 

is shipped, in writing, of the restrictions 

described in this subpart in accordance 

with paragraphs (b) and (c) of this 

section. 

(b) The following text must be 

inserted in Sections 1(c) and 15 of the 

Safety Data Sheet (SDS): 

Color Index Pigment Violet 29 

(regulated PV29) is subject to additional 

respiratory protection and cleaning 

requirements under 40 CFR part 751, 

subpart J. Please review the 

requirements before opening this 

container and using this product. 

(c) Every regulated PV29 product 

shall bear a label. The label shall appear 

on or be securely attached to the 

immediate container of the regulated 

PV29 product. The contents of a label 

must show clearly and prominently the 

following: 

Color Index Pigment Violet 29 (PV29) is 

stored within this container. Regulated PV29 

is subject to additional respiratory protection 

and cleaning requirements under 40 CFR part 

751, subpart J. Please review the 

requirements before opening this container 

and using this product. 

§ 751.909 Recordkeeping requirements. 

(a) General records. After [DATE 60 

DAYS AFTER DATE OF PUBLICATION 

OF FINAL RULE IN THE FEDERAL 

REGISTER], all persons who 

manufacture, process, distribute in 

commerce, or engage in industrial or 

commercial use of regulated PV29 must 

maintain ordinary business records, 

such as downstream notifications, 

invoices, and bills-of-lading related to 

compliance with the restrictions and 

other provisions of this subpart. 

(b) Respiratory protection records. 

Owners or operators subject to 

respiratory protection requirements 

described in § 751.905(c) must retain 

records of: 

(1) Respiratory protection used and 

implementation; and 

(2) Information and training provided 

by the regulated entity to each person 

prior to or at the time of initial 

assignment to a job involving potential 

inhalation exposure to regulated PV29. 

(c) Equipment and area cleaning 

records. Owners or operators subject to 

the requirements described in 

§ 751.905(b) must maintain records of: 


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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Proposed Rules 3131 

(1) A copy of the current cleaning 

plan and previous versions; 

(2) The dates, duration, and 

completion status of equipment and 

area cleaning each time a cleaning plan 

is executed; 

(3) Implementation records 

documenting the initial date of cleaning 

plan implementation; and 

(4) Documentation that instruction 

has been provided to potentially 

exposed persons whose job function 

includes cleaning plan implementation 

or whose job function requires them to 

be present in a regulated area where a 

cleaning plan could be executed. 

(d) Retention. Owners or operators 

must retain the records required in 

paragraphs (a) through (c) of this section 

for five years from the date that such 

records were generated. 

[FR Doc. 2024–30931 Filed 1–13–25; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

45 CFR Parts 205, 260, 261, and 263 

RIN 0970–AC97 

Strengthening Temporary Assistance 

for Needy Families (TANF) as a Safety 

Net and Work Program; Withdrawal 

AGENCY: Administration for Children 

and Families (ACF), HHS. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: This document withdraws a 

proposed rule that was published in the 

Federal Register on October 2, 2023. 

The proposed rule would have amended 

the Temporary Assistance for Needy 

Families (TANF) program regulations to 

strengthen the safety net and reduce 

administrative burden. 

DATES: The Administration for Children 

and Families is withdrawing the 

proposed rule published October 2, 

2023 (88 FR 67697) as of January 14, 

2025. 

FOR FURTHER INFORMATION CONTACT: The 

Office of Family Assistance, ACF, at 

TANFquestions@acf.hhs.gov or 202– 

401–9275. Deaf and hard of hearing 

individuals may call 202–401–9275 

through their chosen relay service or 

711 between 8 a.m. and 7 p.m. Eastern 

Time. 

SUPPLEMENTARY INFORMATION: The 

Administration for Children and 

Families (ACF) published a notice of 

proposed rulemaking (NPRM) related to 

the administration of TANF in the 

Federal Register on October 2, 2023 (88 

FR 67697). The NPRM proposed to (1) 

establish a ceiling on the term ‘‘needy’’; 

(2) clarify when an expenditure is 

‘‘reasonably calculated to accomplish a 

TANF purpose’’; (3) exclude as an 

allowable TANF maintenance-of-effort 

(MOE) expenditures cash donations 

from non-governmental third parties 

and the value of third-party in-kind 

contributions; (4) ensure that excused 

holidays match the number of Federal 

holidays, following the recognition of 

Juneteenth as a Federal holiday; (5) 

develop new criteria to allow States to 

use alternative Income and Eligibility 

Verification System (IEVS) measures; (6) 

clarify the ‘‘significant progress’’ criteria 

following a work participation rate 

corrective compliance plan; and (7) 

clarify the existing regulatory text about 

the allowability of costs associated with 

disseminating program information. 

However, upon further consideration, 

the Department has elected to withdraw 

the Strengthening TANF as a Safety Net 

and Work Program Notice of Proposed 

Rulemaking published in the Federal 

Register on 10/02/2023, effective 

January 14, 2025. The Department 

appreciates the more than 7,000 

comments received from State agencies, 

advocates and a broad range of 

additional stakeholders. In making the 

decision to withdraw the NPRM, the 

Department continues to recognize the 

importance of rulemaking to ensure that 

TANF funds are used in a manner 

consistent with statutory requirements. 

However, the Department has 

determined that it could benefit from 

additional public input and 

consideration on a set of issues relating 

to allowable TANF spending before 

adopting a final rule. With the time left 

in this Administration, the Department 

is focusing on other matters, including 

implementing the TANF provisions of 

the Fiscal Responsibility Act of 2023, 

and it is not feasible to solicit additional 

public comments. The Department has 

concluded that withdrawing the NPRM 

will assure agency flexibility in reexamining and exploring options and 

alternatives with stakeholders in the 

future prior to developing an NPRM that 

could draw from this additional 

stakeholder engagement. For these 

independently sufficient reasons, the 

Department is withdrawing this NPRM. 

The NPRM published on October 2, 

2023, is hereby withdrawn. 

Dated: January 7, 2025. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2025–00537 Filed 1–13–25; 8:45 am] 

BILLING CODE 4184–36–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R4–ES–2024–0050; 

FXES1111090FEDR–256–FF09E21000] 

RIN 1018–BH60 

Endangered and Threatened Wildlife 

and Plants; Threatened Status for the 

Florida Manatee and Endangered 

Status for the Antillean Manatee 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), propose to 

list the two subspecies of the West 

Indian manatee, the Florida manatee 

(Trichechus manatus latirostris) and the 

Antillean manatee (Trichechus manatus 

manatus), under the Endangered 

Species Act of 1973, as amended (Act). 

We have conducted status reviews for 

the two subspecies, and, as a result, we 

are proposing to list the Florida manatee 

as a threatened species with protective 

regulations under section 4(d) of the Act 

(‘‘4(d) rule’’), and the Antillean manatee 

as an endangered species, under the 

Act. These two listings would replace 

the current threatened species listing of 

the West Indian manatee (Trichechus 

manatus). This determination also 

serves as our 12-month findings on two 

petitions and as our completed 5-year 

review of the West Indian manatee. If 

we finalize this rule as proposed, it 

would remove the West Indian manatee 

from the Federal List of Endangered and 

Threatened Wildlife (List), add the 

Florida manatee and Antillean manatee 

to the List, and extend the Act’s 

protections to the Florida manatee and 

Antillean manatee. 

DATES: We will accept comments 

received or postmarked on or before 

March 17, 2025. Comments submitted 

electronically using the Federal 

eRulemaking Portal (see ADDRESSES, 

below) must be received by 11:59 p.m. 

eastern time on the closing date. We 

must receive requests for an additional 

public hearing, in writing, at the address 

shown in FOR FURTHER INFORMATION

CONTACT by February 28, 2025. 

Public informational meeting and 

public hearing: On February 26, 2025, 

we will hold a public informational 

meeting followed by a public hearing 

from 5 p.m. to 7 p.m., Eastern-Standard 

time (6 p.m. to 8 p.m., Atlantic-Standard 

time). For more information, see Public 

Hearing, below. 


khammond on DSK9W7S144PROD with PROPOSALS