Notice2022-19093
Colour Index Pigment Violet 29 (PV29); Revision to the Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 6, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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of OSHA's chemical-specific permissible exposure limits largely adopted in the 1970's are described by OSHA as being "outdated and inadequate for ensuring protection of worker health," or because OSHA has not issued a chemical-specific permissible exposure limit (PEL) (as is the case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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 171 (Tuesday, September 6, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Pages 54491-54496]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19093]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#6e1a0f1702011c400a1702020f002e0b1e0f40090118"><span class="__cf_email__" data-cfemail="cfbbaeb6a3a0bde1abb6a3a3aea18faabfaee1a8a0b9">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#7420273735593c1b00181d1a11341104155a131b02"><span class="__cf_email__" data-cfemail="36626575771b7e59425a5f58537653465718515940">[email protected]</span></a>.
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: <a href="https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf">https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf</a>.
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: <a href="https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations">https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations</a>). 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:
<bullet> Manufacturing--Domestic manufacture;
<bullet> Manufacturing--Import;
<bullet> Processing: Incorporation into formulation, mixture, or
reaction products in paints and coatings;
<bullet> Processing: Incorporation into formulation, mixture, or
reaction products in plastic and rubber products;
<bullet> Processing: Intermediate in the creation or adjustment of
color of other perylene pigments;
<bullet> Processing: Recycling;
<bullet> Industrial/commercial use in paints and coatings for
automotive (OEM and refinishing);
<bullet> Industrial/commercial use in paints and coatings for
coatings and basecoats;
<bullet> Industrial/commercial use in merchant ink for commercial
printing; and
<bullet> Disposal.
The following conditions of use do not drive EPA's unreasonable
risk determination for PV29:
<bullet> Distribution in commerce;
<bullet> Industrial/commercial use in plastic and rubber products--
automobile plastics;
<bullet> Industrial/commercial use in plastic and rubber products--
industrial carpeting; and
<bullet> 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. <a href="https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf">https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf</a>.
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: <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0604-0126">https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0604-0126</a>.
9. Occupational Safety and Health Administration. Permissible
Exposure Limits--Annotated Tables. Accessed June 13, 2022. <a href="https://www.osha.gov/annotated-pels">https://www.osha.gov/annotated-pels</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 6, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.