Document ID: EPA-HQ-OPPT-2016-0725-0089
Agency: epa
Document Type: Notice
Title: Toxic Substances Control Act Risk Determination: Colour Index Pigment Violet 29 (PV29)
Posted Date: 2022-09-06T04:00Z

[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Pages 54491-54496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19093]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0725; FRL-9403-02-OCSPP]

Colour Index Pigment Violet 29 (PV29); Revision to the Toxic 
Substances Control Act (TSCA) Risk Determination; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final revision to the risk determination for the 
Colour Index Pigment Violet 29 (PV29) risk evaluation issued under the 
Toxic Substances Control Act (TSCA). The revision to the PV29 risk 
determination reflects the announced policy changes to ensure the 
public is protected from unreasonable risks from chemicals in a way 
that is supported by science and the law. EPA determined that PV29, as 
a whole chemical substance, presents an unreasonable risk of injury to 
health when evaluated under its conditions of use. In addition, this 
revised risk determination does not reflect an assumption that workers 
always appropriately wear personal protective equipment (PPE). EPA 
understands that there could be occupational safety protections in 
place at workplace locations; however, not assuming use of PPE reflects 
EPA's recognition that unreasonable risk may exist for subpopulations 
of workers that may be highly exposed because they are not covered by 
Occupational Safety and Health Administration (OSHA) standards, or 
their employers are out of compliance with OSHA standards, or because 
many of OSHA's chemical-specific permissible exposure limits largely 
adopted in the 1970's are described by OSHA as being ``outdated and 
inadequate for ensuring protection of worker health,'' or because OSHA 
has not issued a chemical-specific permissible exposure limit (PEL) (as 
is the case for PV29), or because EPA finds unreasonable risk for 
purposes of TSCA notwithstanding OSHA requirements. This revision 
supersedes the condition of use-specific no unreasonable risk 
determinations in the January 2021 PV29 Risk Evaluation and withdraws 
the associated TSCA order included in the January 2021 PV29 Risk 
Evaluation.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2016-0725, is available online 
at https://www.regulations.gov or in-person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Dyllan Taylor, Office of 
Pollution Prevention and Toxics (7404T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-2913; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422

[[Page 54492]]

South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-
1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to those involved in the manufacture, processing, 
distribution, use, disposal, and/or the assessment of risks involving 
chemical substances and mixtures. You may be potentially affected by 
this action if you manufacture (defined under TSCA to include import), 
process (including recycling), distribute in commerce, use or dispose 
of PV29, including PV29 in products. Since other entities may also be 
interested in this revision to the risk determination, EPA has not 
attempted to describe all the specific entities that may be affected by 
this action.

B. What is EPA's authority for taking this action?

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk 
evaluations to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other nonrisk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
(PESS) identified as relevant to the risk evaluation by the 
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A). 
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and 
minimum requirements applicable to this process, including provisions 
that provide instruction on chemical substances that must undergo 
evaluation, the minimum components of a TSCA risk evaluation, and the 
timelines for public comment and completion of the risk evaluation. 
TSCA also requires that EPA operate in a manner that is consistent with 
the best available science, make decisions based on the weight of the 
scientific evidence, and consider reasonably available information. 15 
U.S.C. 2625(h), (i), and (k).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other nonrisk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    EPA has inherent authority to reconsider previous decisions and to 
revise, replace, or repeal a decision to the extent permitted by law 
and supported by reasoned explanation. FCC v. Fox Television Stations, 
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v. 
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983).

C. What action is EPA taking?

    EPA is announcing the availability of the final revision to the 
risk determination for the PV29 risk evaluation issued under TSCA that 
published in January 2021. In March 2022, EPA sought public comment on 
the draft revisions (87 FR 12690, March 7, 2022). EPA appreciates the 
public comments received on the draft revision to the PV29 risk 
determination. After review of these comments and consideration of the 
specific circumstances of PV29, EPA concludes that the Agency's risk 
determination for PV29 is better characterized as a whole chemical risk 
determination rather than condition-of-use-specific risk 
determinations. Accordingly, EPA is revising and replacing section 5 of 
the January 2021 PV29 Risk Evaluation (Ref. 1) where the findings of 
unreasonable risk to health and the environment were previously made 
for the individual conditions of use evaluated. EPA is also withdrawing 
the previously issued TSCA section 6(i)(l) order for four conditions of 
use previously determined not to present unreasonable risk which was 
included in section 5.4.1 of the January 2021 PV29 Risk Evaluation 
(Ref. 1).
    This final revision to the PV29 risk determination is consistent 
with EPA's plans to revise specific aspects of the first ten TSCA 
chemical risk evaluations to ensure that the risk evaluations better 
align with TSCA's objective of protecting health and the environment. 
The ten conditions of use identified in the January 2021 PV29 Risk 
Evaluation (Ref. 1) as presenting unreasonable risk still drive the 
unreasonable risk determination for PV29. Removing the assumption that 
workers always and appropriately wear PPE (see unit II.C) does not 
alter the conditions of use or worker subpopulations driving the 
unreasonable risk determination for PV29. Four out of 14 conditions of 
use do not drive the unreasonable risk determination for PV29, and 
those conditions of use have been identified in the final revised 
unreasonable risk determination. However, EPA is not making condition-
of-use-specific risk determinations for those conditions of use, and 
for purposes of TSCA section 6(i), EPA is not issuing a final order 
under TSCA section 6(i)(1) and does not consider the revised risk 
determination to constitute a final agency action at this point in 
time. Overall, ten conditions of use drive the PV29 whole chemical 
unreasonable risk determination due to risks identified for human 
health. The full list of the conditions of use evaluated for the PV29 
TSCA risk evaluation is in table 1-3 of the 2021 PV29 Risk Evaluation 
(Ref. 1) available here: https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf.

II. Background

A. Why is EPA re-issuing the risk determination for the PV29 risk 
evaluation conducted under TSCA?

    In accordance with Executive Order 13990 (``Protecting Public 
Health and the Environment and Restoring Science to Tackle the Climate 
Crisis'') and other Administration priorities (Refs. 2, 3, 4, and 5), 
EPA reviewed the risk evaluations for the first ten chemical 
substances, including PV29, to ensure that they meet the requirements 
of TSCA, including conducting decision-making in a manner that is 
consistent with the best available science.
    As a result of this review, EPA announced plans to revise specific 
aspects of the first ten risk evaluations in order to ensure that the 
risk evaluations appropriately identify unreasonable risks and thereby 
help ensure the protection of human health and the environment 
(available here: https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations). Following a review of specific 
aspects of the January 2021 PV29 Risk Evaluation (Ref. 1) and after 
considering comments received on a

[[Page 54493]]

draft revised risk determination for PV29, EPA has determined that 
making an unreasonable risk determination for PV29 as a whole chemical 
substance, rather than making unreasonable risk determinations 
separately on each individual condition of use evaluated in the risk 
evaluation, is the most appropriate approach for PV29 under the statute 
and implementing regulations. In addition, EPA's final risk 
determination is explicit insofar as it does not rely on assumptions 
regarding the use of PPE in making the unreasonable risk determination 
under TSCA section 6, even though some facilities might be using PPE as 
one means to reduce worker exposures; rather, the use of PPE as a means 
of addressing unreasonable risk will be considered during risk 
management, as appropriate.
    This action pertains only to the risk determination for PV29. While 
EPA intends to consider and may take additional similar actions on 
other of the first ten chemicals, EPA is taking a chemical-specific 
approach to reviewing these risk evaluations and is incorporating new 
policy direction in a surgical manner, while being mindful of 
Congressional direction on the need to complete risk evaluations and 
move toward any associated risk management activities in accordance 
with statutory deadlines.

B. What is a whole chemical view of the unreasonable risk determination 
for the PV29 risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical 
substance presents unreasonable risk under its conditions of use. 
Stakeholders have disagreed over whether a chemical substance should 
receive: A single determination that is comprehensive for the chemical 
substance after considering the conditions of use, referred to as a 
whole-chemical determination; or multiple determinations, each of which 
is specific to a condition of use, referred to as condition-of-use-
specific determinations.
    As explained in the Federal Register document announcing the 
availability of the draft revised risk determination for PV29 (87 FR 
12690, March 7, 2022), the proposed Risk Evaluation Procedural Rule 
(Ref. 6) was premised on the whole chemical approach to making 
unreasonable risk determinations. In that proposed rule, EPA 
acknowledged a lack of specificity in statutory text that might lead to 
different views about whether the statute compelled EPA's risk 
evaluations to address all conditions of use of a chemical substance or 
whether EPA had discretion to evaluate some subset of conditions of use 
(i.e., to scope out some manufacturing, processing, distribution in 
commerce, use, or disposal activities), but also stated that ``EPA 
believes the word `the' [in TSCA section 6(b)(4)(A)] is best 
interpreted as calling for evaluation that considers all conditions of 
use.'' The proposed rule, however, was unambiguous on the point that 
unreasonable risk determinations would be for the chemical substance as 
a whole, even if based on a subset of uses. See Ref. 6 at 7565-66 
(``TSCA section 6(b)(4)(A) specifies that a risk evaluation must 
determine whether `a chemical substance' presents an unreasonable risk 
of injury to health or the environment `under the conditions of use.' 
The evaluation is on the chemical substance--not individual conditions 
of use--and it must be based on `the conditions of use.' In this 
context, EPA believes the word `the' is best interpreted as calling for 
evaluation that considers all conditions of use.''). In proposed 
regulatory text, EPA proposed to determine whether the chemical 
substance presents an unreasonable risk of injury to health or the 
environment under the conditions of use. (Ref. 6 at 7480).
    The final Risk Evaluation Procedural Rule stated (82 FR 33726, July 
20, 2017 (FRL-9964-38)) (Ref. 7): ``As part of the risk evaluation, EPA 
will determine whether the chemical substance presents an unreasonable 
risk of injury to health or the environment under each condition of 
uses [sic] within the scope of the risk evaluation, either in a single 
decision document or in multiple decision documents'' (40 CFR 702.47). 
For the unreasonable risk determinations in the first ten risk 
evaluations, EPA applied this provision by making individual risk 
determinations for each condition of use evaluated as part of each risk 
evaluation document (i.e., the condition-of-use-specific approach to 
risk determinations). That approach was based on one particular passage 
in the preamble to the final Risk Evaluation Rule which stated that EPA 
will make individual risk determinations for all conditions of use 
identified in the scope. (Ref. 7 at 33744).
    In contrast to this portion of the preamble of the final Risk 
Evaluation Rule, the regulatory text itself and other statements in the 
preamble reference a risk determination for the chemical substance 
under its conditions of use, rather than separate risk determinations 
for each of the conditions of use of a chemical substance. In the key 
regulatory provision excerpted previously from 40 CFR 702.47, the text 
explains that, ``[a]s part of the risk evaluation, EPA will determine 
whether the chemical substance presents an unreasonable risk of injury 
to health or the environment under each condition of uses [sic] within 
the scope of the risk evaluation, either in a single decision document 
or in multiple decision documents'' (emphasis added). Other language 
reiterates this perspective. For example, 40 CFR 702.31(a) states that 
the purpose of the rule is to establish the EPA process for conducting 
a risk evaluation to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment as required 
under TSCA section 6(b)(4)(B). Likewise, there are recurring references 
to whether the chemical substance presents an unreasonable risk in 40 
CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which explains 
that the extent to which EPA will refine its evaluations for one or 
more condition of use in any risk evaluation will vary as necessary to 
determine whether a chemical substance presents an unreasonable risk. 
Notwithstanding the one preambular statement about condition-of-use-
specific risk determinations, the preamble to the final rule also 
contains support for a risk determination on the chemical substance as 
a whole. In discussing the identification of the conditions of use of a 
chemical substance, the preamble notes that this task inevitably 
involves the exercise of discretion on EPA's part, and ``as EPA 
interprets the statute, the Agency is to exercise that discretion 
consistent with the objective of conducting a technically sound, 
manageable evaluation to determine whether a chemical substance--not 
just individual uses or activities--presents an unreasonable risk.'' 
(Ref. 7 at 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk 
evaluation regulation to also allow the Agency to issue whole-chemical 
risk determinations. Either approach is permissible under the 
regulation. A panel of the Ninth Circuit Court of Appeals also 
recognized the ambiguity of the regulation on this point. Safer 
Chemicals v. EPA, 943 F.3d 397, 413 (9th Cir. 2019) (holding a 
challenge about ``use-by-use risk evaluations [was] not justiciable 
because it is not clear, due to the ambiguous text of the Risk 
Evaluation Rule, whether the Agency will actually conduct risk 
evaluations in the manner Petitioners fear'').
    EPA plans to consider the appropriate approach for each chemical 
substance

[[Page 54494]]

risk evaluation on a case-by-case basis, taking into account 
considerations relevant to the specific chemical substance in light of 
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's 
ability to evaluate and manage unreasonable risk from individual 
chemical substances. EPA believes this is a reasonable approach under 
TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of PV29, EPA has 
determined that a whole chemical approach is appropriate for PV29 in 
order to protect health and the environment. The whole chemical 
approach is appropriate for PV29 because there are benchmark 
exceedances for substantial number of conditions of use (spanning 
across most aspects of the chemical lifecycle--from manufacturing 
(including import), processing, industrial and commercial use, and 
disposal) for health of workers and occupational non-users and severe 
health effects (specifically alveolar hyperplasia) associated with PV29 
exposures. Because these chemical-specific properties cut across the 
conditions of use within the scope of the risk evaluation, a 
substantial amount of the conditions of use drive the unreasonable 
risk; therefore, it is appropriate for the Agency to make a 
determination for PV29 that the whole chemical presents an unreasonable 
risk.
    As explained later in this document, the revisions to the 
unreasonable risk determination (section 5 of the 2021 PV29 Risk 
Evaluation (Ref. 1)) follow the issuance of a draft revision to the 
TSCA PV29 unreasonable risk determination (87 FR 12690, March 07, 2022) 
and the receipt of public comment. A response to comments document is 
also being issued with the final revised unreasonable risk 
determination for PV29. The revisions to the unreasonable risk 
determination are based on the existing risk characterization section 
of the 2021 PV29 Risk Evaluation (Ref. 1) (section 4) and do not 
involve additional technical or scientific analysis. The discussion of 
the issues in this Federal Register document and in the accompanying 
final revised risk determination for PV29 supersede any conflicting 
statements in the January 2021 PV29 Risk Evaluation (Ref. 1) and the 
earlier response to comments document (Ref. 8). EPA views the peer 
reviewed hazard and exposure assessments and associated risk 
characterization as robust and upholding the standards of best 
available science and weight of the scientific evidence per TSCA 
sections 26(h) and (i).
    For purposes of TSCA section 6(i), EPA is making a risk 
determination on PV29 as a whole chemical. Under the revised approach, 
the ``whole chemical'' risk determination for PV29 supersedes the no 
unreasonable risk determinations for PV29 that were premised on a 
condition-of-use-specific approach to determining unreasonable risk and 
also contains an order withdrawing the TSCA section 6(i)(1) order in 
section 5.4.1 of the January 2021 PV29 Risk Evaluation (Ref. 1).

C. What revision is EPA now making final about the use of PPE for the 
PV29 risk evaluation?

    In the risk evaluations for the first ten chemical substances, as 
part of the unreasonable risk determination, EPA assumed for several 
conditions of use that workers were provided and always used PPE in a 
manner that achieves the stated assigned protection factor (APF) for 
respiratory protection, or used impervious gloves for dermal 
protection. In support of this assumption, EPA used reasonably 
available information such as public comments indicating that some 
employers, particularly in the industrial setting, provide PPE to their 
employees and follow established worker protection standards (e.g., 
OSHA requirements for protection of workers).
    For the January 2021 PV29 Risk Evaluation (Ref. 1), EPA assumed, 
based on information provided by the manufacturer of PV29, that workers 
use PPE--specifically, respirators with an APF ranging from 10 to 25--
for eight conditions of use. In the January 2021 PV29 Risk Evaluation 
(Ref. 1), however, EPA determined that there is unreasonable risk to 
these workers even with this assumed PPE use.
    EPA is revising the assumption for PV29 that workers always or 
properly use PPE, although it does not question the public comments 
received regarding the occupational safety practices often followed by 
industry respondents. When characterizing the risk to human health from 
occupational exposures during risk evaluation under TSCA, EPA believes 
it is appropriate to evaluate the levels of risk present in baseline 
scenarios where PPE is not assumed to be used by workers. This approach 
of not assuming PPE use by workers considers the risk to potentially 
exposed or susceptible subpopulations of workers who may not be covered 
by OSHA standards, such as self-employed individuals and public sector 
workers who are not covered by a State Plan. It should be noted that, 
in some cases, baseline conditions may reflect certain mitigation 
measures, such as engineering controls, in instances where exposure 
estimates are based on monitoring data at facilities that have 
engineering controls in place.
    In addition, EPA believes it is appropriate to evaluate the levels 
of risk present in scenarios considering applicable OSHA requirements 
(e.g., chemical-specific permissible exposure limits (PELs) and/or 
chemical-specific PELs with additional substance-specific standards) as 
well as scenarios considering industry or sector best practices for 
industrial hygiene that are clearly articulated to the Agency. 
Consistent with this approach, the January 2021 PV29 Risk Evaluation 
(Ref. 1) characterized risk to workers both with and without the use of 
PPE. By characterizing risks using scenarios that reflect different 
levels of mitigation, EPA risk evaluations can help inform potential 
risk management actions by providing information that could be used 
during risk management to tailor risk mitigation appropriately to 
address any unreasonable risk identified, or to ensure that applicable 
OSHA requirements or industry or sector best practices that address the 
unreasonable risk are required for all potentially exposed and 
susceptible subpopulations (including self-employed individuals and 
public sector workers who are not covered by an OSHA State Plan).
    When undertaking unreasonable risk determinations as part of TSCA 
risk evaluations, however, EPA does not believe it is appropriate to 
assume as a general matter that an applicable OSHA requirement or 
industry practice related to PPE use is consistently and always 
properly applied. Mitigation scenarios included in the EPA risk 
evaluation (e.g., scenarios considering use of various PPE) likely 
represent what is happening already in some facilities. However, the 
Agency cannot assume that all facilities have adopted these practices 
for the purposes of making the TSCA risk determination.
    Therefore, EPA is making a determination of unreasonable risk for 
PV29 from a baseline scenario that does not assume compliance with OSHA 
standards, including any applicable exposure limits or requirements for 
use of respiratory protection or other PPE. Making unreasonable risk 
determinations based on the baseline scenario should not be viewed as 
an indication that EPA believes there are no occupational safety 
protections in place at any location, or that there is widespread non-
compliance with applicable OSHA standards. Rather, it reflects EPA's 
recognition that

[[Page 54495]]

unreasonable risk may exist for subpopulations of workers that may be 
highly exposed because they are not covered by OSHA standards, such as 
self-employed individuals and public sector workers who are not covered 
by a State Plan, or because their employer is out of compliance with 
OSHA standards, or because their employer is out of compliance with 
OSHA standards, or because many of OSHA's chemical-specific permissible 
exposure limits largely adopted in the 1970's are described by OSHA as 
being ``outdated and inadequate for ensuring protection of worker 
health,'' (Ref. 9), or because OSHA has not issued a permissible 
exposure limit (PEL) (as is the case for PV29), or because EPA finds 
unreasonable risk for purposes of TSCA notwithstanding OSHA 
requirements.
    In accordance with this approach, EPA is finalizing the revision to 
the PV29 risk determination without relying on assumptions regarding 
the occupational use of PPE in making the unreasonable risk 
determination under TSCA section 6; rather, information on the use of 
PPE as a means of mitigating risk (including public comments received 
from industry respondents about occupational safety practices in use) 
will be considered during the risk management phase, as appropriate. 
This represents a change from the approach taken in the 2021 PV29 Risk 
Evaluation (Ref. 1). As a general matter, when undertaking risk 
management actions, EPA intends to strive for consistency with 
applicable OSHA requirements and industry best practices, including 
appropriate application of the hierarchy of controls, to the extent 
that applying those measures would address the identified unreasonable 
risk, including unreasonable risk to potentially exposed or susceptible 
subpopulations. Consistent with TSCA section 9(d), EPA will consult and 
coordinate TSCA activities with OSHA and other relevant Federal 
agencies for the purpose of achieving the maximum applicability of TSCA 
while avoiding the imposition of duplicative requirements. Informed by 
the mitigation scenarios and information gathered during the risk 
evaluation and risk management process, the Agency might propose rules 
that require risk management practices that may be already common 
practice in many or most facilities. Adopting clear, comprehensive 
regulatory standards will foster compliance across all facilities 
(ensuring a level playing field) and assure protections for all 
affected workers, especially in cases where current OSHA standards may 
not apply or be sufficient to address the unreasonable risk.
    By removing the assumption of PPE use in making the whole chemical 
risk determination for PV29, there are no additional conditions of use 
or worker subpopulations that drive the unreasonable risk 
determination. The same ten conditions of use continue to drive EPA's 
unreasonable risk determination for PV29 as a whole chemical. The 
finalized revision to the PV29 risk determination clarifies that EPA 
does not rely on the assumed use of PPE when making the risk 
determination for the whole substance.

D. What is PV29?

    PV29 is a high color strength, weather fast and heat stable pigment 
used in various industrial, commercial, and consumer applications. 
Domestic manufacture of PV29 is conducted by a sole manufacturer. 
Imported PV29 pigment, without being processed into a different 
product, makes up a very small market share of the PV29 supply chain. 
Leading applications for PV29 include use as an intermediate to create 
or adjust color of other perylene pigments, incorporation into paints 
and coatings used in the automobile industry, incorporation into 
plastic and rubber products used in automobiles and industrial 
carpeting, use in merchant ink for commercial printing, and use in 
consumer watercolors and acrylic artist paint.

E. What conclusions is EPA finalizing today in the revised TSCA risk 
evaluation based on the whole chemical approach and not assuming the 
use of PPE?

    EPA determined that PV29 presents an unreasonable risk to health 
under the conditions of use. EPA's unreasonable risk determination for 
PV29 is driven by risks associated with the following conditions of 
use, considered singularly or in combination with other exposures:
     Manufacturing--Domestic manufacture;
     Manufacturing--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/commercial use in paints and coatings for 
automotive (OEM and refinishing);
     Industrial/commercial use in paints and coatings for 
coatings and basecoats;
     Industrial/commercial use in merchant ink for commercial 
printing; and
     Disposal.
    The following conditions of use do not drive EPA's unreasonable 
risk determination for PV29:
     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.
    EPA is not making condition of use-specific risk determinations for 
these conditions of use, is not issuing a final order under TSCA 
section 6(i)(1) for these conditions of use, and does not consider the 
revised risk determination for PV29 to constitute a final agency action 
at this point in time.
    Consistent with the statutory requirements of TSCA section 6(a), 
EPA will propose risk management regulatory action to the extent 
necessary so that PV29 no longer presents an unreasonable risk. EPA 
expects to focus its risk management action on the conditions of use 
that drive the unreasonable risk. However, it should be noted that, 
under TSCA section 6(a), EPA is not limited to regulating the specific 
activities found to drive unreasonable risk and may select from among a 
suite of risk management requirements in section 6(a) related to 
manufacture (including import), processing, distribution in commerce, 
commercial use, and disposal as part of its regulatory options to 
address the unreasonable risk. As a general example, EPA may regulate 
upstream activities (e.g., processing, distribution in commerce) to 
address downstream activities (e.g., consumer uses) driving 
unreasonable risk, even if the upstream activities do not drive the 
unreasonable risk.

III. Summary of Public Comments

    EPA received a total of 14 public comments on the March 7, 2022, 
draft revised risk determination for PV29 during the comment period 
that ended April 21, 2022. Commenters included trade organizations, 
industry stakeholders, environmental groups, and non-governmental and 
health advocacy organizations. A separate document that summarizes all 
comments submitted and EPA's responses to those comments has been 
prepared and is available in the docket for this notice (Ref. 10).

[[Page 54496]]

IV. Revision of the January 2021 PV29 Risk Evaluation

A. Why is EPA revising the risk determination for the PV29 risk 
evaluation?

    EPA is finalizing the revised risk determination for the PV29 risk 
evaluation pursuant to TSCA section 6(b) and consistent with Executive 
Order 13990 (``Protecting Public Health and the Environment and 
Restoring Science to Tackle the Climate Crisis'') and other 
Administration priorities (Refs. 2, 3, 4, and 5). EPA is revising 
specific aspects of the first ten TSCA existing chemical risk 
evaluations in order to ensure that the risk evaluations better align 
with TSCA's objective of protecting health and the environment. For the 
PV29 risk evaluation, this includes: (1) making the risk determination 
in this instance based on the whole chemical substance instead of by 
individual conditions of use and (2) emphasizing that EPA does not rely 
on the assumed use of PPE when making the risk determination.

B. What are the revisions?

    EPA is now finalizing the revised risk determination for the 2021 
PV29 Risk Evaluation (Ref. 1) pursuant to TSCA section 6(b). Under the 
revised determination, EPA concludes that PV29, as evaluated in the 
risk evaluation as a whole, presents an unreasonable risk of injury to 
health when evaluated under its conditions of use. This revision 
replaces the previous unreasonable risk determinations made for PV29 by 
individual conditions of use, supersedes the determinations (and 
withdraws the associated order) of no unreasonable risk for the 
conditions of use identified in the TSCA section 6(i)(1) no 
unreasonable risk order, and clarifies the lack of reliance on assumed 
use of PPE as part of the risk determination.
    These revisions do not alter any of the underlying technical or 
scientific information that informs the risk characterization, and as 
such the hazard, exposure, and risk characterization sections are not 
changed, except to statements about PPE assumptions in section 2.3.1.4 
(Consideration of Engineering Controls and PPE), paragraph four, and 
section 4.2.3 (table 4-5, Assumed PPE Protection Considered for Risk 
Determination by COU, and introductory text). The discussion of the 
issues in this Notice and in the accompanying final revision to the 
risk determination supersede any conflicting statements in the prior 
executive summary, and section 2.3.1.4 and section 4.2.3 (table 4-5) 
from the January 2021 PV29 Risk Evaluation (Ref. 1) and the response to 
comments document (Ref. 8).
    The revised unreasonable risk determination for PV29 includes 
additional explanation of how the risk evaluation characterizes the 
applicable OSHA requirements, or industry or sector best practices, and 
also clarifies that no additional analysis was done, and the risk 
determination is based on the risk characterization (section 4) of the 
2021 PV29 Risk Evaluation (Ref. 1).

C. Will the revised risk determination be peer reviewed?

    The risk determination (section 5 of the 2021 PV29 Risk Evaluation 
(Ref. 1)) was not part of the scope of the Science Advisory Committee 
on Chemicals (SACC) peer review of the PV29 risk evaluation. Thus, 
consistent with that approach, EPA did not conduct peer review of the 
final revised unreasonable risk determination for the PV29 risk 
evaluation because no technical or scientific changes were made to the 
hazard or exposure assessments or the risk characterization.

V. Order Withdrawing Previous Order Regarding Unreasonable Risk 
Determinations for Certain Conditions of Use

    EPA is also issuing a new order to withdraw the TSCA section 
6(i)(1) no unreasonable risk order issued in section 5.4.1 of the 2021 
PV29 Risk Evaluation (Ref. 1). This final revised risk determination 
supersedes the condition of use-specific no unreasonable risk 
determinations in the January 2021 PV29 Risk Evaluation (Ref. 1). The 
order contained in section 5.5 of the revised risk determination (Ref. 
11) withdraws the TSCA section 6(i)(1) order contained in section 5.4.1 
of the January 2021 PV29 Risk Evaluation (Ref. 1). Consistent with the 
statutory requirements of section 6(a), the Agency will propose risk 
management action to address the unreasonable risk determined in the 
PV29 risk evaluation.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Risk Evaluation for C.I. Pigment Violet 29. EPA Document 
#740-R-18-015. January 2021. https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf.
2. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. 
Federal Register (86 FR 7037, of January 25, 2021).
3. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register (86 FR 7009, January 25, 2021).
4. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register (86 FR 7619, February 1, 2021).
5. Presidential Memorandum. Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
6. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register (82 FR 
7562, January 19, 2017) (FRL-9957-75).
7. EPA. Final Rule Procedures for Chemical Risk Evaluation Under the 
Amended Toxic Substances Control Act. Federal Register (82 FR 33726, 
33744, July 20, 2017).
8. EPA. Summary of External Peer Review and Public Comments and 
Disposition for Colour Index Pigment Violet 29 (PV29). January 2021. 
Available at: https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0604-0126.
9. Occupational Safety and Health Administration. Permissible 
Exposure Limits--Annotated Tables. Accessed June 13, 2022. https://www.osha.gov/annotated-pels.
10. EPA. Response to Public Comments to the Revised Unreasonable 
Risk Determination; Colour Index Pigment Violet 29 (PV29). July 
2022.
11. EPA. Unreasonable Risk Determination for Colour Index Pigment 
Violet 29 (PV29). July 2022.

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

    Dated: August 30, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-19093 Filed 9-2-22; 8:45 am]
BILLING CODE 6560-50-P