[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12690-12696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04672]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0725; FRL-9403-01-OCSPP]


Colour Index Pigment Violet 29 (PV29); Draft Revision to Toxic 
Substances Control Act (TSCA) Risk Determination; Notice of 
Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and requesting public comment on a draft revision to 
the risk determination for the Colour Index Pigment Violet 29 (PV 29) 
risk evaluation issued under TSCA. The draft revision to the PV 29 risk 
determination was developed following a review of the first ten risk 
evaluations issued under TSCA that was done in

[[Page 12691]]

accordance with Executive Orders and other Administration priorities, 
including those on environmental justice, scientific integrity, and 
regulatory review, and this draft revision reflects the announced 
policy changes to ensure the public is protected from unreasonable 
risks from chemicals in a way that is supported by science and the law. 
Specifically, in this draft revision to the risk determination EPA 
finds that PV 29, as a whole chemical substance, presents an 
unreasonable risk of injury to health when evaluated under its 
conditions of use. This draft revision would supersede the condition of 
use-specific no unreasonable risk determinations in the January 2021 PV 
29 risk evaluation (and withdraw the associated order) and make a 
revised determination of unreasonable risk for PV 29 as a whole 
chemical substance. In addition, this draft revised risk determination 
does not reflect an assumption that workers always appropriately wear 
personal protective equipment (PPE).

DATES: Comments must be received on or before April 21, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-EPA-HQ-OPPT-2016-0725, using the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is by appointment only. For the 
latest status information on EPA/DC services and docket access, visit 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Todd Coleman, Office of 
Pollution Prevention and Toxics (7404T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-1208; email address: [email protected].
    For general information contact: 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?

    This action is directed to the public in general. This action may, 
however, be of interest to those involved in the manufacture, 
processing, distribution, use, disposal, and/or the assessment of risks 
involving chemical substances and mixtures. You may be potentially 
affected by this action if you manufacture (defined under TSCA to 
include import), process (including recycling), distribute in commerce, 
use or dispose of PV 29, including PV 29 in products. Since other 
entities may also be interested in this draft revision to the risk 
determination, the EPA has not attempted to describe all the specific 
entities that may be affected by this action.

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

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

C. What action is EPA taking?

    EPA is announcing the availability of and seeking public comment on 
a draft revision to the risk determination for the risk evaluation for 
PV 29 under TSCA, published in January 2021 (Ref. 1). EPA is 
specifically seeking public comment on the draft revision to the risk 
determination for the risk evaluation where the agency intends to 
determine that PV 29, as a whole chemical, presents an unreasonable 
risk of injury to health when evaluated under its conditions of use. 
This whole chemical approach to determining unreasonable risk to health 
is permissible under EPA's statutory obligations under TSCA section 
6(b)(4) and the implementing regulations and would revise and replace 
section 5 of the risk evaluation for PV 29 where the findings of 
unreasonable risk to health were previously made for the individual 
conditions of use evaluated.
    This revision would be consistent with EPA's plans to revise 
specific aspects of the first ten TSCA chemical risk evaluations in 
order to ensure that the risk evaluations better align with TSCA's 
objective of protecting health and the environment. Under the draft 
revision, the same ten conditions of use would continue to drive the 
unreasonable risk determination for PV 29. Removing the assumptions of 
PPE use in making the whole chemical risk determination for PV 29 would 
not alter the conditions of use or worker subpopulations that drive the 
unreasonable risk determination for PV 29. Overall, ten conditions of 
use drive the PV 29 whole chemical unreasonable risk determination due 
to risks identified for human health. The full list of the conditions 
of use evaluated for the PV 29 risk evaluation is in Table 5-1 of the 
risk evaluation (Ref. 1).

[[Page 12692]]

D. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. Why is EPA re-issuing the risk determination for the PV 29 risk 
evaluation conducted under TSCA?

    In 2016, as directed by TSCA section 6(b)(2)(A), EPA chose the 
first ten chemical substances to undergo risk evaluations under the 
amended TSCA. These chemical substances are asbestos, 1-bromopropane, 
carbon tetrachloride, C.I. Pigment Violet 29 (PV 29), cyclic aliphatic 
bromide cluster (HBCD), 1,4-dioxane, methylene chloride, n-
methylpyrrolidone (NMP), perchloroethylene (PCE), and trichloroethylene 
(TCE).
    From June 2020 to January 2021, EPA published risk evaluations on 
the first ten chemical substances, including for PV 29 in January 2021. 
The risk evaluations included individual unreasonable risk 
determinations for each condition of use evaluated. The determinations 
that particular conditions of use did not present an unreasonable risk 
were issued by order under TSCA section 6(i)(1).
    In accordance with Executive Order 13990 (Ref. 2) and other 
Administration priorities (Refs. 3, 4, and 5), EPA is reviewing the 
risk evaluations for the first ten chemical substances to ensure that 
they meet the requirements of TSCA, including conducting decision 
making in a manner that is consistent with the best available science.
    As a result of this review, EPA announced plans to revise specific 
aspects of the first ten risk evaluations in order to ensure that the 
risk evaluations appropriately identify unreasonable risks and thereby 
help ensure the protection of human health and the environment 
available here https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations. To that end, EPA is 
reconsidering two key aspects of the risk determinations for PV 29 
published in January 2021. First, based on EPA's review, EPA proposes 
that the appropriate approach to these determinations under the statute 
and implementing regulations is to make an unreasonable risk 
determination for PV 29 as a whole chemical substance, rather than 
making unreasonable risk determinations separately on each individual 
condition of use evaluated in the risk evaluation. Second, EPA proposes 
that the risk determination should be explicit that it does not rely on 
assumptions regarding the use of personal protective equipment (PPE) in 
making the unreasonable risk determination under TSCA section 6; 
rather, the use of PPE would be considered during risk management.
    This action pertains only to the risk determination for PV 29. 
While EPA intends to consider and may take additional similar actions 
on other of the first ten chemicals, EPA is taking a chemical-specific 
approach to reviewing the risk evaluations and is incorporating new 
policy direction in a surgical manner, while being mindful of the 
Congressional direction on the need to complete risk evaluations and 
move toward any associated risk management activities in accordance 
with statutory deadlines. To the extent the Agency deems appropriate, 
additional actions may follow that are specific to each of the chemical 
substances for which EPA has issued final risk evaluations under TSCA 
section 6.

B. What is a whole chemical view of the unreasonable risk determination 
for the PV 29 risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical 
substance presents unreasonable risk under its conditions of use. 
Stakeholders have disagreed over whether a chemical substance should 
receive: A single determination that is comprehensive for the chemical 
substance after considering the conditions of use, referred to as a 
whole-chemical determination; or multiple determinations, each of which 
is specific to a condition of use, referred to as condition-of-use-
specific determinations. EPA acknowledges a lack of specificity in the 
statute and inconsistency in the regulations with respect to the 
presentation of risk determinations in TSCA risk evaluations.
    The proposed risk evaluation procedural rule was premised on the 
whole chemical approach to making unreasonable risk determinations 
(Ref. 6). EPA acknowledged a lack of specificity in whether the statute 
compelled EPA's risk evaluations to address all conditions of use of a 
chemical substance or whether EPA had discretion to evaluate some 
subset of conditions of use (i.e., to scope out some manufacturing, 
processing, distribution in commerce, use, or disposal activities). The 
proposed rule, however, was unambiguous on the point that unreasonable 
risk determinations would be for the chemical substance as a whole, 
even if based on a subset of uses. (See Ref. 6 at pgs. 7565-66: ``TSCA 
section 6(b)(4)(A) specifies that a risk evaluation must determine 
whether `a chemical substance' presents an unreasonable risk of injury 
to health or the environment `under the conditions of use.' The 
evaluation is on the chemical substance--not individual conditions of 
use--and it must be based on `the conditions of use.' In this context, 
EPA believes the word `the' is best interpreted as calling for 
evaluation that considers all conditions of use.''). In the proposed 
regulatory text, EPA proposed to ``determine whether the chemical 
substance presents an unreasonable risk of injury to health or the 
environment under the conditions of use as identified in the final 
scope document . . .'' (Ref. 6 at pg. 7480).
    As stated in the final risk evaluation procedural rule (Ref. 7): 
``As part of the risk evaluation, EPA will determine whether the 
chemical substance presents an unreasonable risk of injury to health or 
the environment under each condition of uses [sic] within the scope of 
the risk evaluation, either in a single decision document or in 
multiple decision documents.'' (See also 40 CFR 702.47). For the 
unreasonable risk determinations in the first ten risk evaluations, EPA 
applied this provision by making individual risk determinations for 
each condition of use evaluated in each risk evaluation (i.e., the 
condition-of-use-specific approach to risk determinations). That 
approach was based on one particular passage in the preamble to the 
final risk evaluation procedural rule: ``The final step of a risk 
evaluation is for EPA to determine whether the chemical substance, 
under the conditions of use, presents an unreasonable risk of injury to 
health or the environment. EPA will make individual risk determinations 
for all uses identified in the scope. This part of the regulation is 
slightly amended from

[[Page 12693]]

the proposed rule, to clarify that the risk determination is part of 
the risk evaluation, as well as to account for the revised approach to 
that [sic] ensures each condition of use covered by the risk evaluation 
receives a risk determination.'' (Ref. 7 at pg. 33744).
    In contrast to this portion of the preamble of the final risk 
evaluation procedural rule, the regulatory text itself and other 
statements in the preamble reference a risk determination for the 
chemical substance under its conditions of use, rather than separate 
risk determinations for each of the conditions of use of a chemical 
substance. In the key regulatory provision excerpted above from 40 CFR 
702.47, the text explains that, ``[a]s part of the risk evaluation, EPA 
will determine whether the chemical substance presents an unreasonable 
risk of injury to health or the environment under each condition of 
uses [sic] within the scope of the risk evaluation, either in a single 
decision document or in multiple decision documents'' (Ref. 7, emphasis 
added). Other language reiterates this perspective. For example, 40 CFR 
702.31(a) states that the purpose of the rule is to establish the EPA 
process for conducting a risk evaluation to determine whether a 
chemical substance presents an unreasonable risk of injury to health or 
the environment as required under TSCA section 6(b)(4)(B). Likewise, 
there are recurring references to whether the chemical substance 
presents an unreasonable risk in 40 CFR 702.41(a). See, for example, 40 
CFR 702.41(a)(6), which states: ``[t]he extent to which EPA will refine 
its evaluations for one or more condition of use in any risk evaluation 
will vary as necessary to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment.'' 
Notwithstanding the one preambular statement about condition-of-use-
specific risk determinations, the preamble to the final rule also 
contains support for a risk determination on the chemical substance as 
a whole. In discussing the identification of the conditions of use of a 
chemical substance, the preamble notes that this task inevitably 
involves the exercise of discretion on EPA's part, and, ``as EPA 
interprets the statute, the Agency is to exercise that discretion 
consistent with the objective of conducting a technically sound, 
manageable evaluation to determine whether a chemical substance--not 
just individual uses or activities--presents an unreasonable risk.'' 
(Ref. 7 at pg. 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk 
evaluation regulation to also allow the Agency to issue 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 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. For 
instance, circumstances in which an unreasonable risk determination is 
primarily driven by a single condition of use that does not impact or 
intersect with other evaluated uses (such as for example, a single 
consumer use of a substance out of a wide range of other manufacturing, 
processing and consumer uses evaluated) may warrant different treatment 
than circumstances in which the majority of the chemical substance's 
conditions of use contribute to unreasonable risk, and the Agency might 
adopt different approaches to the risk determinations in those 
particular instances. EPA anticipates that this flexibility will better 
serve TSCA's objectives by helping ensure that EPA is best positioned 
to present, and initiate risk management to address, chemical-specific 
unreasonable risk determinations. EPA believes this is a reasonable 
approach under TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of PV 29, as further 
explained in this notice, EPA proposes that a whole chemical approach 
better aligns with TSCA's objective of protecting health and the 
environment. For PV 29, EPA favors the whole chemical approach based in 
part on the benchmark exceedances for multiple conditions of use 
(spanning across most aspects of the chemical lifecycle--from 
manufacturing (including import), processing, commercial and industrial 
use, and disposal) for health of workers and occupational non-users and 
the irreversible health effects (specifically alveolar hyperplasia) 
associated with PV 29 exposures. Since the chemical-specific properties 
cut across the conditions of use within the scope of the risk 
evaluation, the Agency's risk findings and conclusions encompass the 
majority of those conditions of use, and the Agency is better 
positioned to achieve its TSCA objectives for PV 29 when issuing a 
whole chemical determination for PV 29, EPA concludes that the Agency's 
risk determination for PV 29 is better characterized as a whole 
chemical risk determination rather than condition-of-use-specific risk 
determinations.
    As explained later in this document, the revisions to the 
unreasonable risk determination (section 5 of the risk evaluation) 
would be based on the existing risk characterization section of the 
risk evaluation (section 4 of the risk evaluation) and would not 
involve additional technical or scientific analysis. The discussion of 
the issues presented in this Federal Register document and in the 
accompanying draft revision to the risk determination would supersede 
any conflicting statements in the prior PV 29 risk evaluation and the 
response to comments document (Ref.). With respect to the PV 29 risk 
evaluation, EPA intends to change the risk determination to a whole 
chemical approach without considering the use of PPE and does not 
intend to amend, nor does a whole chemical approach require amending, 
the underlying scientific analysis of the risk evaluation in the risk 
characterization section of the risk evaluation. EPA views the peer 
reviewed hazard and exposure assessments and associated risk 
characterization as robust and upholding the standards of best 
available science and weight of the scientific evidence per TSCA 
sections 26(h) and (i).
    EPA is announcing the availability of and seeking public comment on 
the draft superseding unreasonable risk determination for PV 29, 
including a list of the condition-of-use-specific risks driving the 
unreasonable risk determination for the chemical substance as a whole. 
For purposes of TSCA section 6(i), EPA is making a risk determination 
on PV 29 as a whole chemical. Under the revised approach, EPA is 
proposing to supersede the no unreasonable risk determinations (and 
withdraw the associated order) for PV 29 that were premised on a 
condition-of-use-specific approach to determining unreasonable risk.

[[Page 12694]]

C. What revision does EPA propose about the use of PPE for the PV 29 
risk evaluation?

    In the risk evaluations for the first ten chemical substances, as 
part of the unreasonable risk determination, EPA assumed for several 
conditions of use that all workers were provided and always used PPE in 
a manner that achieves the stated assigned protection factor (APF) for 
respiratory protection, or protection factor (PF) for dermal 
protection. In support of this assumption, EPA used reasonably 
available information such as public comments indicating that some 
employers, particularly in the industrial setting, provide PPE to their 
employees and follow established worker protection standards (e.g., 
Occupational Safety and Health Administration (OSHA) requirements for 
protection of workers).
    For the January 2021 PV 29 risk evaluation, EPA assumed based on 
information provided by the manufacturer of PV 29 that workers use 
PPE--specifically, respirators with an APF ranging from 10 to 25--for 
eight conditions of use. However, in the January 2021 PV 29 risk 
evaluation, EPA determined that there is unreasonable risk to these 
workers even with this assumed PPE use.
    When characterizing the risk to human health from occupational 
exposures during risk evaluation under TSCA, EPA believes it is 
appropriate to evaluate the levels of risk present in baseline 
scenarios where no mitigation measures are assumed to be in place. It 
should be noted that, in some cases, baseline conditions may reflect 
certain mitigation measures, such as engineering controls, in instances 
where exposure estimates are based on monitoring data at facilities 
that have engineering controls in place. This approach considers the 
risk to potentially exposed or susceptible subpopulations of workers 
who may not be covered by OSHA standards, such as self-employed 
individuals and public sector workers who are not covered by a State 
Plan.
    In addition, EPA believes it is appropriate to evaluate the levels 
of risk present in scenarios considering applicable OSHA requirements 
(e.g., chemical-specific permissible exposure limits (PELs) and/or 
chemical-specific PELs with additional substance-specific standards) as 
well as scenarios considering industry or sector best practices for 
industrial hygiene that are clearly articulated to the Agency. It 
should be noted that, in some cases, baseline conditions may reflect 
certain mitigation measures, such as engineering controls, in instances 
where exposure estimates are based on monitoring data at facilities 
that have engineering controls in place. Consistent with this approach, 
the January 2021 PV 29 risk evaluation characterized risk to workers 
both with and without the use of PPE.
    When undertaking unreasonable risk determinations as part of TSCA 
risk evaluations, however, EPA does not believe it is appropriate to 
assume as a general matter that an applicable OSHA requirement or 
industry practice is sufficient to address the risk, applicable to all 
potentially exposed workers, or consistently and always properly 
applied. Mitigation scenarios included in the EPA risk evaluation 
(e.g., scenarios considering use of various PPE) likely represent what 
is happening already in some facilities. However, the Agency cannot 
assume that all facilities have adopted these practices for the 
purposes of making the TSCA risk determination. Additionally, as 
previously noted, self-employed individuals and public sector workers 
who are not covered by a State Plan are not covered by OSHA 
requirements. By characterizing risks using scenarios that reflect 
different levels of mitigation, EPA risk evaluations can help inform 
potential risk management actions by providing information that could 
be used during risk management to tailor risk mitigation appropriately 
to address any unreasonable risk identified.
    Therefore, going forward, EPA intends to make its determination of 
unreasonable risk from a baseline scenario that does not assume 
compliance with OSHA standards, including any applicable exposure 
limits or requirements for use of respiratory protection or other PPE. 
Making unreasonable risk determinations based on the baseline scenario 
should not be viewed as an indication that EPA believes there are no 
occupational safety protections in place at any location, or that there 
is widespread non-compliance with applicable OSHA standards. Rather, it 
reflects EPA's recognition that unreasonable risk may exist for 
subpopulations of workers that may be highly exposed because they are 
not covered by OSHA standards, such as self-employed individuals and 
public sector workers who are not covered by a State Plan, or because 
their employer is out of compliance with OSHA standards, or because EPA 
finds unreasonable risk for purposes of TSCA notwithstanding OSHA 
requirements.
    In accordance with this approach, EPA proposes that the draft 
revision to the PV 29 risk determination not rely on assumptions 
regarding the occupational use of PPE in making the unreasonable risk 
determination under TSCA section 6; rather, the use of PPE would be 
considered during risk management. This would represent a change from 
the approach taken in the 2021 risk evaluation for PV 29 and EPA 
invites comments on this draft change to the PV29 risk determination. 
As a general matter, when undertaking risk management actions, EPA 
intends to strive for consistency with applicable OSHA requirements and 
industry best practices, including appropriate application of the 
hierarchy of controls, when those measures would address an 
unreasonable risk; ensure the EPA requirements apply to all potentially 
exposed workers; and develop occupational risk mitigation measures to 
address any unreasonable risks identified by EPA. Consistent with TSCA 
section 9(d), EPA will consult and coordinate TSCA activities with OSHA 
and other relevant Federal agencies for the purpose of achieving the 
maximum applicability of TSCA while avoiding the imposition of 
duplicative requirements. Informed by the mitigation scenarios and 
information gathered during the risk evaluation and risk management 
process, the Agency might propose rules that require risk management 
practices that may be already common practice in many or most 
facilities. Adopting clear, comprehensive regulatory standards will 
foster compliance across all facilities (ensuring a level playing 
field) and assure protections for all affected workers, especially in 
cases where current OSHA standards may not apply or be sufficient to 
address the unreasonable risk.
    By removing the assumptions of PPE use in making the whole chemical 
risk determination for PV 29 would not alter the conditions of use that 
drive EPA's unreasonable risk determination for PV 29 as a whole 
chemical. The draft revision to the risk determination would clarify 
that EPA does not rely on the assumed use of PPE when making the risk 
determination for the whole substance. EPA is requesting comment on 
this potential change.

D. What is PV 29?

    PV 29 is a high color strength, weather fast and heat stable 
pigment used in various industrial, commercial, and consumer 
applications. Domestic manufacture of PV 29 is conducted by a sole 
manufacturer. Imported PV 29 pigment, without being processed into a 
different product, makes up a very small market share of the PV 29 
supply chain.

[[Page 12695]]

Leading applications for C.I. Pigment Violet 29 include use as an 
intermediate to create or adjust color of other perylene pigments, 
incorporation into paints and coatings used primarily in the automobile 
industry, incorporation into plastic and rubber products used primarily 
in automobiles and industrial carpeting, use in merchant ink for 
commercial printing, and use in consumer watercolors and artistic 
color.

E. What conclusions did EPA reach about the risks of PV 29 in the TSCA 
risk evaluation based on the whole chemical approach and not assuming 
the use of PPE?

    EPA determined that PV 29 presents an unreasonable risk to health 
driven by risk associated with the following conditions of use: 
Manufacture (including import); processing (incorporation into 
formulation, mixture, or reaction products including paints and 
coatings and plastic and rubber products; processing as an intermediate 
in the creation of adjustment of color or other perylene pigments; and 
recycling); industrial/commercial use of PV 29 in automotive (Original 
Equipment Manufacture (OEM) and refinishing) paints and coatings, 
coatings and basecoats, and merchant ink for commercial printing; and 
disposal of PV 29. By removing the assumption of PPE use in making the 
whole chemical risk determination for PV 29, there are no additional 
conditions of use or worker subpopulations that would drive the draft 
unreasonable risk determination. The same ten COUs would continue to 
drive EPA's unreasonable risk determination.

III. Revision of the January 2021 Risk Evaluation

A. Why is EPA proposing to revise the risk determination for the PV 29 
risk evaluation?

    EPA is proposing to revise the risk determination for the PV 29 
risk evaluation pursuant to TSCA section 6(b) and consistent with 
Executive Order 13990, (``Protecting Public Health and the Environment 
and Restoring Science to Tackle the Climate Crisis'') and other 
Administration priorities (Refs. 1, 3, and 4). EPA plans to consider 
revising specific aspects of the first ten TSCA existing chemical risk 
evaluations in order to ensure that the risk evaluations better align 
with TSCA's objective of protecting health and the environment. For the 
PV 29 risk evaluation, this includes the draft revision: (1) Making the 
risk determination in this instance based on the whole chemical 
substance instead of by individual conditions of use (which would 
result in the new determination superseding the determinations and the 
withdrawal of the associated order of no unreasonable risk for the 
conditions of use identified in the no unreasonable risk order), and 
(2) clarifying that the risk determination does not rely on assumed use 
of PPE.

B. What are the draft revisions?

    EPA is releasing a draft revision of the risk determination for the 
PV 29 risk evaluation pursuant to TSCA section 6(b). Under the revised 
determination, EPA proposes to conclude that PV 29, as evaluated in the 
risk evaluation as a whole, presents an unreasonable risk of injury to 
health when evaluated under its conditions of use. This revision would 
replace the previous unreasonable risk determinations made for PV 29 by 
individual conditions of use, supersede the determinations (and 
withdraw the associated order) of no unreasonable risk for the 
conditions of use identified in the no unreasonable risk order, and 
clarify the lack of reliance on assumed use of PPE as part of the risk 
determination.
    These draft revisions do not alter any of the underlying technical 
or scientific information that informs the risk characterization, and 
as such the hazard, exposure, and risk characterization sections are 
not changed except to the extent that statements about PPE assumptions 
in section 2.3.1.4 (Consideration of Engineering Controls and PPE), 
paragraph four, of the PV 29 risk evaluation would be superseded. The 
discussion of the issues in this Notice and in the accompanying draft 
revision to the risk determination would supersede any conflicting 
statements in the prior executive summary and section 2.3.1.4 from the 
PV 29 risk evaluation and the response to comments document (Ref. 8). 
Additional policy changes to other chemical risk evaluations, including 
any consideration of potentially exposed and susceptible subpopulations 
and/or inclusion of additional exposure pathways, are not necessarily 
reflected in these draft revisions to the risk determination.

C. Will the draft revised risk determination be peer reviewed?

    The risk determination (section 5 in the January 2021 risk 
evaluation) was not part of the scope of the peer reviews of the first 
ten chemicals by the Science Advisory Committee on Chemicals (SACC). 
Thus, consistent with that approach, EPA does not intend to conduct 
peer review for the draft revised unreasonable risk determination for 
the PV 29 risk evaluation because no technical or scientific changes 
will be made to the hazard or exposure assessments or the risk 
characterization.

D. What are the next steps for finalizing revisions to the risk 
determination?

    EPA will review and consider public comment received on the draft 
revised risk determination for the PV 29 risk evaluation and, after 
considering those public comments, issue the revised final PV 29 risk 
determination. If finalized as drafted, EPA would also issue a new 
order to withdraw the TSCA section 6(i)(1) no unreasonable risk order 
issued in section 5.4.1 of the 2021 PV29 risk evaluation. This final 
revised risk determination would supersede the January 2021 risk 
determinations of no unreasonable risk. Consistent with the statutory 
requirements of TSCA section 6(a), the Agency would then propose risk 
management actions to address the unreasonable risk determined in the 
PV 29 risk evaluation.

IV. References

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

1. EPA Risk Evaluation for C.I. Pigment Violet 29. EPA Document 
#740-R-18-015. January 2021. https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf.
2. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. 
Federal Register. 86 FR 7037, January 25, 2021.
3. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register. 86 FR 7009, January 25, 2021.
4. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
5. Presidential Memorandum. Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking. Federal Register. 86 FR 8845, February 10, 2021.
6. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act.

[[Page 12696]]

Federal Register. 82 FR 7562, January 18, 2017 (FRL-9957-75).
7. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register. 82 FR 
33726, July 20, 2017 (FRL-9964-38).
8. EPA. Summary of External Peer Review and Public Comments and 
Disposition for C.I. Pigment Violet 29 (PV29) (Anthra[2,1,9-
def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone). January 
2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0604-0126.

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

Michael S. Regan,
Administrator.
[FR Doc. 2022-04672 Filed 3-4-22; 8:45 am]
BILLING CODE 6560-50-P