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[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Proposed Rules]
[Pages 3107-3131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30931]

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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.

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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: 

[[Page 3108]]

    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: 
[email protected].
    For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: [email protected].

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/tsca-import-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

[[Page 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

[[Page 3110]]

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 high-performance 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.

[[Page 3111]]

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 physical-chemical 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

[[Page 3112]]

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 time-limited 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, non-public 
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 non-cancer 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

[[Page 3116]]

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 worksite-
specific 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 non-powered 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 air-purifying respirator; any NIOSH-
certified half-mask supplied-air respirator or airline respirator in 
continuous flow mode or pressure-demand 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 self-contained 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

[[Page 3118]]

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

[[Page 3119]]

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/m\3\). 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 chemical-specific 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

[[Page 3120]]

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

[[Page 3121]]

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 physical-chemical 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 chemical-specific 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

[[Page 3122]]

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/m\3\ 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).

[[Page 3123]]

    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-the-art 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

[[Page 3124]]

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

[[Page 3125]]

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 self-employed 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

[[Page 3126]]

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 non-powered 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-cause-cancer (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-and-plan#A1.
19. EPA. Final Risk Evaluation for C.I. Pigment Violet 29 (PV29) 
Supplemental

[[Page 3127]]

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-of-controls/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/wp-content/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/laws-regulations/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

[[Page 3128]]

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

[[Page 3129]]

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-managing-chemicals-under-tsca/materials-june-2021-environmental-justice-consultations. 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

0
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).
0
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.

Sec.  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.

Sec.  751.903  Definitions.

    In addition to the definitions that apply to this part established 
in Sec.  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.

Sec.  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

[[Page 3130]]

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 half-mask power air-
purifying respirator; any NIOSH-certified half-mask supplied-air 
respirator or airline respirator in continuous flow mode or pressure-
demand 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 self-contained 
breathing apparatus in demand mode (APF 50). Negative-pressure 
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 Sec.  
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.

Sec.  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.

Sec.  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 Sec.  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 Sec.  751.905(b) must maintain 
records of:

[[Page 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
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