[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12690-12696]
[FR Doc No: 2022-04672]

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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.

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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

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:<PHONE_NUMBER>; 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).

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

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.

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.

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 <IP_ADDRESS> (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 <IP_ADDRESS> 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.

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


[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Rules and Regulations]
[Pages 20793-20796]
[FR Doc No: 2013-07975]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0402; FRL-9797-6]

Approval and Promulgation of Implementation Plans; Mississippi;
110(a)(2)(E)(ii) Infrastructure Requirements for the 1997 and 2006 Fine
Particulate Matter National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve in part, and disapprove
in part, the State Implementation Plan (SIP) submission, provided by
the Mississippi Department of Environmental Quality (MDEQ), on October
11, 2012. This submission pertains to specific Clean Air Act (CAA)
requirements for the 1997 annual and 2006 24-hour fine particulate
matter (PM2.5) National Ambient Air Quality Standards
(NAAQS) infrastructure SIPs. This action focuses on one component of
the infrastructure requirements in the CAA. The CAA requires states to
include provisions in their SIP to address conflicts of interest for
state boards or bodies that approve CAA permits and enforcement orders
and disclosure of conflict of interest requirements. Specifically, EPA
is now approving the submission as it relates to the public interest
requirements of CAA and the conflict of interest disclosure provisions.
EPA is also now disapproving Mississippi's submission only as it
pertains to compliance with the significant portion of income
requirements of the CAA. Through this action, EPA is only taking action
on the infrastructure SIP requirement related to Mississippi's
obligation to address conflicts of interest requirements for state
boards or bodies that approve CAA permits and enforcement orders and
disclosure of conflict of interest requirements. All other applicable
Mississippi infrastructure elements for the 1997 annual and 2006 24-
hour PM2.5 NAAQS have been addressed through separate
rulemakings. EPA is also taking action to finalize substantive SIP
revisions included with MDEQ's October 11, 2012, submission.

DATES: Effective Date: This rule will be effective May 8, 2013.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2012-0402. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30 excluding federal
holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. This Action
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997 (62 FR 38652), EPA promulgated a new annual
PM2.5 NAAQS and on October 17, 2006 (71 FR 61144), EPA
promulgated a new 24-hour PM2.5 NAAQS. Upon promulgation of
a new or revised NAAQS, section 110(a) of the CAA requires states to
submit SIPs providing for the implementation, maintenance, and
enforcement of a new or revised NAAQS within three years following the
promulgation of such NAAQS, or within such shorter period as EPA may
prescribe. More specifically, section 110(a)(1) provides the procedural
and timing requirements for SIPs, and section 110(a)(2) lists specific
elements that states must meet for ``infrastructure'' SIP requirements
related to a newly established or revised NAAQS. The section 110(a)(2)
requirements include SIP infrastructure elements such as modeling,
monitoring, and emissions inventories that are designed to assure
attainment and maintenance of the NAAQS.
    Section 110(a) imposes the obligation upon states to make a SIP
submission to EPA for a new or revised NAAQS, but the contents of that
submission may vary depending upon the facts and circumstances. The
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affects the content of the
submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains. For many of the section 110(a) requirements, states have
typically met these basic program elements through earlier SIP
submissions in connection with previous NAAQS.
    Mississippi submitted a SIP revision on October 11, 2012, to
address section 110(a)(2)(E)(ii) infrastructure requirements for both
the 1997 annual and 2006 24-hour PM2.5 NAAQS. On August 9,
2012, EPA proposed to approve in part, and disapprove in part,
Mississippi's infrastructure SIP submission addressing section
110(a)(2)(E)(ii).\1\
---------------------------------------------------------------------------

    \1\ EPA took action on Mississippi's other applicable
infrastructure SIP requirements in a separate rulemaking. See 77 FR
61276.
---------------------------------------------------------------------------

    Section 110(a)(2)(E)(ii) of the infrastructure SIP requires that
states comply with the requirements respecting state boards provided at
Section 128 of the CAA. Section 128, in turn, requires that states
include provisions in their SIP to address conflicts of interest for
state boards or bodies that approve CAA permits and enforcement orders
and to address disclosure of conflict of interest requirements.
Specifically, CAA section 128(a)(1) necessitates that each SIP shall
require that at least a majority of any board or body which approves
permits or enforcement orders be subject to public interest service and
income restrictions. Section 128(a)(2) requires that the members of any
board or body, or the head of an executive agency with similar power to
approve permits or enforcement orders under the CAA, shall also be
subject to conflict of interest disclosure requirements.
    In addition to the above-described proposed partial approval and
partial disapproval of Mississippi's infrastructure SIP submission

addressing section 110(a)(2)(E)(ii), EPA also proposed to approve
certain sections of the Mississippi Constitution and Mississippi Code
into the SIP. Specifically, EPA proposed to approve Mississippi's
Article 4, Section 109 of the Mississippi Constitution and portions of
Mississippi Code sections 25-4-25, -27, -29, -101, -103, and -105 into
the Mississippi SIP. These SIP revisions satisfy certain conflict of
interest requirements of section 128, which as described above, are
required as part of the state's infrastructure SIP per section
110(a)(2)(E)(ii). More information on these specific provisions is
provided in the proposed rule for today's action (77 FR 47573) and in
the state's October 11, 2012, final SIP revision which is available in
the docket for today's action.

II. This Action

    EPA is taking final action to approve Article 4, Section 109 of
Mississippi Constitution and portions of Mississippi Code sections 25-
4-25, -27, -29, -101, -103, and -105 into the Mississippi SIP pursuant
to section 128 of the CAA. The specific provisions for inclusion in the
Mississippi SIP are described more fully in the State's October 11,
2012, final SIP revision which is available in the docket for today's
action.
    EPA is also taking final action to approve in part Mississippi's
110(a)(2)(E)(ii) infrastructure submission as it relates to the public
interest requirements of CAA section 128(a)(1) and the conflict of
interest disclosure provisions of section 128(a)(2). EPA is
disapproving Mississippi's section 110(a)(2)(E)(ii) submission only as
it pertains to compliance with the significant portion of income
requirements of section 128(a)(1) of the CAA. See the August 9, 2012,
proposed rule for EPA's analysis of Mississippi's 110(a)(2)(E)(ii)
submission. (77 FR 47573). The 110(a)(2)(E)(ii) proposed actions were
contingent upon Mississippi providing EPA with a final SIP revision
that was not changed significantly from the July 13, 2012, draft
revision. Mississippi provided its final SIP revision on October 11,
2012. There were no significant changes made to the final submittal.
EPA received no comments on its August 9, 2012, proposed partial
approval and partial disapproval of Mississippi's draft SIP revision
addressing section 110(a)(2)(E)(ii).
    Although EPA is taking action to disapprove a portion of
Mississippi's 110(a)(2)(E)(ii) submission, the Agency notes that
Mississippi has submitted a number of SIP revisions that are being
determined adequate for approvability regarding the requirements of
section 128. For example, Mississippi Code Section 25-4-105 precludes
all public servants from using his or her official position to obtain,
or attempt to obtain, pecuniary benefit for him- or herself other than
that compensation provided for by law, or to obtain, or attempt to
obtain, pecuniary benefit for any relative or any business with which
he or she is associated. In addition, this section prevents board
members from performing any service for any compensation during their
term by which they attempt to influence a decision of the authority of
the board. EPA interprets these requirements, once incorporated into
the SIP, as demonstrating that Mississippi meets the section 128(a)(1)
requirements respecting public interest.
    EPA also notes that the public policy declared by the Mississippi
Legislature in Mississippi Code Annotated section 25-4-101, which is
being approved into the SIP today, in large part comports with the
intent behind the CAA section 128 requirements.\2\
---------------------------------------------------------------------------

    \2\ Section 25-4-101 provides that the Mississippi Legislature
``declares that elective and public office and employment is a
public trust and any effort to realize personal gain through
official conduct, other than as provided by law, or as a natural
consequence of the employment or position, is a violation of that
trust. Therefore, public servants shall endeavor to pursue a course
of conduct which will not raise suspicion among the public that they
are likely to be engaged in acts that are in violation of this trust
and which will not reflect unfavorably upon the state and local
governments.''
---------------------------------------------------------------------------

III. Final Action

    As already described, EPA is taking final action to approve in part
Mississippi's October 11, 2012, submission for the 1997 annual and 2006
24-hour PM2.5 NAAQS addressing section 110(a)(2)(E)(ii)
infrastructure requirements as it relates to the public interest
requirements of CAA section 128(a)(1) and the conflict of interest
disclosure provisions of section 128(a)(2). EPA is disapproving
Mississippi's section 110(a)(2)(E)(ii) submission as it pertains to
compliance with the significant portion of income requirements of
section 128(a)(1) of the CAA.
    Under section 179(a) of the CAA, final disapproval of a submittal
that addresses a requirement of a Part D Plan (42 U.S.C. sections 7501-
7515) or is required in response to a finding of substantial inadequacy
as described in section 7410(k)(5) (SIP call) starts a sanctions clock.
Section 110(a)(2)(E)(ii) provisions (the significant portion of income
requirements of section 128(a)(1) being disapproved in today's notice)
were not submitted to meet requirements for Part D, and therefore, no
sanctions will be triggered. This partial disapproval action, however,
does trigger the requirement under section 110(c) that EPA promulgate a
FIP no later than 2 years from the date of the disapproval unless the
state corrects the deficiency and the Administrator approves the plan
or plan revision before the Administrator promulgates such FIP.
    In addition, to the above actions respecting 110(a)(2)(E)(ii)
infrastructure requirements, EPA is today also approving into the SIP
the revisions related to section 128 submitted by Mississippi on
October 11, 2012. Specifically, EPA is approving Article 4, Section 109
of Mississippi Constitution and portions of Mississippi Code sections
25-4-25, -27, -29, -101, -103, and -105 into the Mississippi SIP.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves in part state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law, and disapproves in part state law because it does
not fully meet federal requirements. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);

     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country, and EPA notes that it
will not impose substantial direct costs on tribal governments or
preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 7, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Incorporation by reference, Nitrogen dioxide, Particulate
Matter, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: March 27, 2013.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart Z--Mississippi

0
2. Section 52.1270 is amended by:
0
a. In paragraph (c), adding an entry under the new heading
``Mississippi State Constitution'' and six entries under the new
heading ``Mississippi Code'' at the end of the table.
0
b. In paragraph (e), adding a new entry for ``110(a)(2)(E)(ii)
Infrastructure Requirement for the 1997 and 2006 Fine Particulate
Matter National Ambient Air Quality Standards'' at the end of the
table.
    The additions read as follows:

Sec.  52.1270  Identification of plan.

* * * * *
    (c) * * *

                                                          EPA-Approved Mississippi Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State
          State citation                             Title/subject                   effective     EPA approval date               Explanation
                                                                                date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Mississippi State Constitution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Article 4 Section 109.............  Interest of Public Officers in Contracts......    9/27/2012  4/8/2013
                                                                                [Insert citation of
                                                                                publication].
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Mississippi Code
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 25-4-25...................  Persons required to file statement of economic    9/27/2012  4/8/2013
                                     interest.                                                   [Insert citation of
                                                                                publication].
Section 25-4-27...................  Contents of statement of economic interest....    9/27/2012  4/8/2013
                                                                                [Insert citation of
                                                                                publication].
Section 25-4-29...................  Filing dates for statement....................    9/27/2012  4/8/2013
                                                                                [Insert citation of
                                                                                publication].
Section 25-4-101..................  Declaration of public policy..................    9/27/2012  4/8/2013
                                                                                [Insert citation of
                                                                                publication].

Section 25-4-103..................  Definitions...................................    9/27/2012  4/8/2013
                                                                                [Insert citation of
                                                                                publication].
Section 25-4-105..................  Certain actions, activities and business          9/27/2012  4/8/2013
                                     relationships prohibited or authorized;                     [Insert citation of
                                     contacts in violation of section voidable;                   publication].
                                     penalties.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                                                   EPA-Approved Mississippi Non-Regulatory Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State
                                                                                submittal
    Name of non-regulatory  SIP       Applicable geographic or nonattainment area      date/       EPA approval date               Explanation
             provision                                                               effective
                                                                                date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
110(a)(2)(E)(ii) Infrastructure     Mississippi...................................   10/11/2012  4/8/2013.............  EPA disapproved the State's
 Requirement for the 1997 and 2006                                                               [Insert citation of     110(a)(2)(E)(ii) as it relates
 Fine Particulate Matter National                                                                 publication].          to section 128(a)(2), the
 Ambient Air Quality Standards.                                                                                significant portion of income
                                                                                requirement.
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
3. Section 52.1278 is amended by designating the existing text as
paragraph (a) and adding paragraph (b) to read as follows:

Sec.  52.1278  Control strategy: Sulfur oxides and particulate matter.

* * * * *
    (b) Disapproval. EPA is disapproving portions of Mississippi's
Infrastructure SIP for the 1997 annual and 2006 24-hour
PM2.5 NAAQS addressing section 110(a)(2)(E)(ii) that
requires the State to comply with section 128 of the CAA.

[FR Doc. 2013-07975 Filed 4-5-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 23, 2008 (Volume 73, Number 185)]
[Rules and Regulations]
[Page 54677-54679]
[DOCID:fr23se08-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0461; Directorate Identifier 2008-NE-14-AD;
Amendment 39-15678; AD 2008-19-11]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Arrius 2B1, 2B1A, 2B2,
and 2K1 Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) provided by the European Aviation
Safety Agency (EASA) to identify and correct an unsafe condition on
Turbomeca S.A. Arrius 2B1, 2B1A, 2B2, and 2K1 turboshaft engines. The
MCAI describes the unsafe condition as:

    A short circuit of some tantalum capacitors inside certain
electronic control (EEC) units may lead to an in-flight shutdown on
one of the two engines resulting from:

--Direct activation of the overspeed electronic protection;
--Non-direct activation of the electronic overspeed protection by
lowering the threshold,
--Spurious activation of the starting sequence; or
--Loss of power control with no freeze of the fuel-metering valve.

We are issuing this AD to prevent in-flight engine shutdowns and
possible forced autorotation landing or accident.

DATES: This AD becomes effective October 8, 2008.
    The Director of the Federal Register approved the incorporation by
reference of Turbomeca S.A. Mandatory Service Bulletin No. 319 73 2835,
Update No. 1, dated December 21, 2006, listed in the AD as of October
8, 2008.
    We must receive comments on this AD by October 23, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC
20590-0001.

     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Community, has issued EASA AD 2008-0018, dated January 24,
2008, to correct an unsafe condition for the specified products. The
EASA AD states:

    A short circuit of some tantalum capacitors inside certain
electronic control (EEC) units may lead to an in-flight shutdown on
one of the two engines resulting from:

--Direct activation of the overspeed electronic protection;
--Non-direct activation of the electronic overspeed protection by
lowering the threshold,
--Spurious activation of the starting sequence; or
--Loss of power control with no freeze of the fuel-metering valve.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Turbomeca S.A. has issued Mandatory Service Bulletin No. 319 73
2835, Update No. 1, dated December 21, 2006. The actions described in
this service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, they have notified us of the unsafe
condition described in the MCAI AD and service information referenced
above. We are issuing this AD because we evaluated all the information
provided by the EASA and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This AD requires identifying, and replacing or modifying affected EEC
units that have tantalum capacitors installed that could have become
brittle during their acceptance test.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
the short compliance time requirement of within the next 100 flight
hours or 2 months, whichever occurs first. Therefore, we determined
that notice and opportunity for public comment before issuing this AD
are impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2008-0461; Directorate
Identifier 2008-NE-14-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.
    Using the search function of the Web site, anyone can find and read
the comments in any of our dockets, including, if provided, the name of
the individual who sent the comment (or signed the comment on behalf of
an association, business, labor union, etc.). You may review the DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-19-11 Turbomeca S.A.: Amendment 39-15678; Docket No. FAA-2008-
0461; Directorate Identifier 2008-NE-14-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective October
8, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Turbomeca S.A. Arrius 2B1, 2B1A, 2B2, and
2K1 turboshaft engines. These engines are installed on, but not
limited to, Eurocopter Deutschland GmbH EC135, and Agusta S.p.A.
A109E helicopters.

Reason

    (d) European Aviation Safety Agency (EASA) AD No. 2008-0018,
dated January 24, 2008, states:

    A short circuit of some tantalum capacitors inside certain
electronic control (EEC) units may lead to an in-flight shutdown on
one of the two engines resulting from:

--Direct activation of the overspeed electronic protection;
--Non-direct activation of the electronic overspeed protection by
lowering the threshold;
--Spurious activation of the starting sequence; or
--Loss of power control with no freeze of the fuel-metering valve.

    This AD requires identifying, and replacing or modifying
affected EEC units that have tantalum capacitors installed that
could have become brittle during their acceptance test. We are
issuing this AD to prevent in-flight engine shutdowns and possible
forced autorotation landing or accident.

Actions and Compliance

    (e) Unless already done, within the next 100 flight hours or 2
months, whichever occurs first after the effective date of this AD,
do the following actions:
    (1) Identify the EEC units as listed in Turbomeca S.A. Mandatory
Service Bulletin No. 319 73 2835, Update No. 1, dated December 21,
2006; and
    (2) For affected EECs, modify or replace the EEC units using the
instructions of Turbomeca S.A. Mandatory Service Bulletin No. 319 73
2835, Update No. 1, dated December 21, 2006.
    (3) After the effective date of this AD, do not install an EEC
with a serial number listed in Turbomeca S.A. Mandatory Service
Bulletin No. 319 73 2835, Update No. 1, dated December 21, 2006 on
any helicopter, unless it has been modified using the instructions
of Turbomeca S.A. Mandatory Service Bulletin No. 319 73 2835, Update
No. 1, dated December 21, 2006.

FAA AD Differences

    (f) This AD requires modification or replacement of both EECs if
both EECs are affected on the same helicopter, whereas MCAI EASA AD
2008-0018, dated January 24, 2008, requires modification of at least
one EEC, if both EECs are affected, and modification or replacement
of the remaining EEC, within 300 flight hours or 12 months,
whichever occurs first.
    (g) This AD immediately prohibits installation of any EECs that
are affected, whereas MCAI EASA AD 2008-0018, dated January 24,
2008, prohibits installation of those EECs after February 7, 2009.
    (h) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification Office, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (i) Refer to MCAI EASA AD 2008-0018, dated January 24, 2008 for
related information.
    (j) Contact James Lawrence, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781) 238-
7199, for more information about this AD.

Material Incorporated by Reference

    (k) You must use Turbomeca S.A. Mandatory Service Bulletin No.
319 73 2835, Update No. 1, dated December 21, 2006, to do the
actions required by this AD.
    (l) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (m) For service information identified in this AD, contact
Turbomeca S.A., 40220 Tarnos, France; telephone 33 05 59 74 40 00,
fax 33 05 59 74 45 15.
    (n) You may review copies at the FAA, New England Region, Office
of the Regional Counsel, 12 New England Executive Park, Burlington,
MA; or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call
(202) 741-6030, or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on September 11, 2008.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E8-21834 Filed 9-22-08; 8:45 am]

BILLING CODE 4910-13-P


                                     Notes
                               October 23, 2019
                         Captan Task Force/EPA Meeting
                              Potomac Yards South
                                9:30 -11:00 am
                                Room PYS-10100

Meeting Goals:
 To discuss the comments on EPA's preliminary human health risk assessment submitted by the Captan Task Force (CTF) to the captan registration review docket.
 To discuss supplemental data submitted by the CTF to inform the risk assessment.
Notes:
 Members of the Captan Task Force (ADAMA and UPL), consultants from Exponent, and EPA staff from the Health Effects Division, the Pesticide Re-evaluation Division, and the Office of Pesticide Programs front office met in person and via phone at the EPA Office of Pesticide Programs offices in Arlington, VA. A list of participants is attached.
 Meeting participants discussed (1) comments the CTF submitted to the captan registration review docket, including two white papers and several supporting literature studies, (2) subsequent submissions of supplemental data and a white paper, and (3) EPA's questions about the comments and submissions.
 Submitted studies included research involving human subjects conducted by the University of Montreal. Because the studies involved deliberate human exposure to captan, meeting participants discussed the regulatory criteria for use of data involving deliberate human exposure (see 26 CFR subpart M), the required information on the ethical conduct of such studies, the process of EPA's review of human research studies, and the role of the agency's Human Studies Review Board, or HSRB.
 The submissions included a human toxicokinetic model for captan Meeting participants discussed additional information needed by EPA for the agency to evaluate and validate the toxicokinetic model.
 Meeting participants discussed comments submitted specific to the dermal absorption of captan and possible ways to refine the dermal absorption value used in the risk assessment.
 Meeting participants discussed supplemental dislodgeable foliar residue (DFR) dissipation data submitted to refine the re-entry assessment for captan.
 Meeting participants also discussed an inhalation white paper submitted to EPA in the summer of 2019.
 EPA is currently reviewing the data submissions. The agency identified barriers to use of some of the submitted data for the CTF and information and actions needed to overcome the barriers.