[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
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magnitude of exposure of the environment to PV29, (iii) the benefits of
PV29 for various uses, and (iv) the reasonably ascertainable economic
consequences of the rule. In evaluating the reasonably ascertainable
economic consequences of the rule, EPA considered (i) the likely effect
of the rule on the national economy, small business, technological
innovation, the environment, and public health, (ii) the costs and
benefits of the proposed regulatory action and of the primary
alternative regulatory action considered, and (iii) the cost
effectiveness of the proposed regulatory action and of the primary
alternative regulatory action considered. See Unit VI. for further
discussion related to TSCA section 6(c)(2)(A) considerations, including
the statement of effects of the proposed rule with respect to these
considerations.
EPA also considered the regulatory authorities under statutes
administered by other agencies such as OSHA's implementation of the OSH
Act, as well as other EPA-administered statutes to examine: (1) whether
there are opportunities for all or part of this risk management action
to be addressed under other statutes, such that a referral may be
warranted under TSCA sections 9(a) or 9(b); or (2) whether TSCA section
6(a) regulation could include alignment of requirements and definitions
in and under existing statutes and regulations to minimize confusion to
the regulated entities and the general public.
In addition, EPA followed other TSCA requirements such as setting
proposed compliance dates in accordance with the requirements in TSCA
section 6(d)(1)(B) (described in the proposed and alternative
regulatory action in Units IV.A and IV.B.).
To the extent information was reasonably available, EPA considered
pollution prevention strategies and the hierarchy of controls adopted
by OSHA and NIOSH when selecting regulatory actions, with the goal of
identifying risk management control methods that are permanent,
feasible, and effective (Ref. 23). EPA also considered how to address
the unreasonable risk while providing flexibility to the regulated
entity where appropriate and took into account the information
presented in the 2021 Risk Evaluation for C.I. Pigment Violet 29, as
well as additional input from stakeholders (as described in Unit
III.A.), and anticipated compliance strategies from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative regulatory action described
in Unit IV. Additional details related to how the requirements in this
unit were incorporated into development of those actions are in Unit V.
IV. Proposed Regulatory and Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
PV29 will no longer present an unreasonable risk of injury to health.
In addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost-effectiveness of the proposed
regulatory action and one or more primary alternative regulatory
actions. In the case of PV29, the proposed regulatory action is
described in Unit IV.A. and the primary alternative regulatory action
considered is described in Unit IV.B. The rationale for the proposed
and alternative regulatory actions and associated compliance timeframes
are discussed in this unit and in more detail in Unit V.A. EPA is
requesting public comment on the proposed regulatory action and
alternative regulatory action, including whether EPA should have more
prescriptive requirements for the cleaning plan.
A. Proposed Regulatory Action
EPA is proposing under TSCA section 6(a) to require specific
workplace protections, including respiratory protection and equipment
and area cleaning, for certain manufacturing, processing, industrial,
and commercial conditions of use. EPA is also proposing to require
recordkeeping and to require manufacturers (including importers),
processors, and distributors of PV29 for any use to provide downstream
notification of requirements.
1. Administrative and Prescriptive Controls
a. Overview
As described in Unit III.B.3, under TSCA section 6(a), EPA is
required to issue a regulation applying one or more of the TSCA section
6(a) requirements to the extent necessary so that the unreasonable risk
of injury to human health or the environment from the chemical
substance is no longer present. The TSCA section 6(a) requirements
provide EPA the authority to limit or prohibit a number of activities,
including, but not limited to, restricting or regulating the
manufacture, processing, distribution in commerce, commercial use, or
disposal of the chemical substance. Given this statutory authority, EPA
may find it appropriate in certain circumstances to propose respiratory
protection requirements for certain occupational conditions of use
where dry powder PV29 would be present (i.e., manufacturing,
processing, industrial and commercial use, or disposal). This unit
describes the proposed prescriptive respiratory protection
requirements.
EPA uses the term ``potentially exposed person'' as defined in 40
CFR 751.5 in this unit and in the regulatory text to include workers
(including occupational non-users), employees, independent contractors,
employers, and all other persons in the work area where PV29 is present
and who may be exposed to PV29 under the conditions of use for which
the proposed respiratory protection requirements would apply. EPA's
proposed respiratory protection requirement would address the
unreasonable risk from PV29 to potentially exposed persons directly
handling the chemical or in the work area where the chemical is being
used. Similarly, the 2021 PV29 risk evaluation did not distinguish
between employers, contractors, or other legal entities or businesses
that manufacture, process, distribute in commerce, use, or dispose of
PV29. For this reason, EPA uses the term ``owner or operator'' as
defined in 40 CFR 751.5 to describe the entity responsible for
implementing the respiratory protection requirements in any workplace
where the proposed respiratory protection requirements would apply. The
term includes any person who owns, leases, operates, controls, or
supervises such a workplace.
EPA also uses the term ``regulated PV29'' in the proposed
regulatory action to describe PV29 in a dry powder form or in dry
powder form when mixed with other types of dry powder pigments.
Additional discussion is found in Unit V.
EPA is proposing respiratory protection requirements and equipment
and area cleaning requirements for the following conditions of use in
cases in which regulated PV29 is manufactured, processed, used, or
disposed of:
Domestic manufacture.
Import.
Processing: Incorporation into formulation, mixture, or
reaction products in paints and coatings.
Processing: Incorporation into formulation, mixture, or
reaction products in plastic and rubber products.
Processing: intermediate in the creation or adjustment of
color of other perylene pigments.
Processing: recycling.
Industrial and commercial use in automobile paints and
coatings (original equipment manufacturing and refinishing).
Industrial and commercial use in coatings and basecoats
for paints and coatings.
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Industrial and commercial use in merchant ink for
commercial printing.
Disposal.
b. PV29 Regulated Area
EPA is proposing to require that owners or operators of workplaces
subject to regulated PV29 respiratory protection or cleaning
requirements demarcate any area where regulated PV29 exposures can
reasonably be expected to occur, meaning that where a regulated PV29
container is open or in use, equipment containing regulated PV29 is in
use or has not yet been cleaned, the area where equipment for regulated
PV29 has not yet been cleaned since equipment usage has ceased, or
cleaning activities are occurring. PV29 regulated areas would be
demarcated using administrative controls, such as warning signs or
highly visible signifiers, in multiple languages as appropriate (e.g.,
based on languages spoken by potentially exposed persons), placed in
conspicuous areas, and documented through training and recordkeeping.
The owner or operator would be required to restrict access to the PV29
regulated area from any potentially exposed person that lacks proper
training, is not wearing required respiratory protection as described
in this unit or is otherwise unauthorized to enter. EPA is proposing to
require owners and operators demarcate a PV29 regulated area beginning
180 days after the date of publication of the final rule. EPA is
soliciting comment on requiring warning signs to demarcate PV29
regulated areas, such as the requirements found in OSHA's General
Industry Standard for Beryllium (29 CFR 1910.1024(m)(2)).
c. Respiratory Protection Requirements
EPA is proposing to require the use of respirators with a minimum
assigned protection factor (APF) of 50, in general alignment with
OSHA's Respiratory Protection Standard at 29 CFR 1910.134. Owners and
operators would be required to provide respiratory protection selected
in accordance with the guidelines described in this unit, that is of
safe design and construction for the work to be performed. EPA is
proposing to require that owners and operators (1) provide respirators
to each potentially exposed person, (2) ensure respirator use, and (3)
maintain respirators in a sanitary, reliable, and undamaged condition.
Owners and operators would be required to select and provide a
respirator that properly fits and communicate respirators selections
each potentially exposed person.
EPA is proposing to require respiratory protection with 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