[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Rules and Regulations]
[Pages 10018-10022]
[FR Doc No: 2021-03027]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0195; FRL-10020-08-Region 3]

Air Plan Approval; West Virginia; 1997 8-Hour Ozone National
Ambient Air Quality Standard Second Maintenance Plan for the West
Virginia Portion of the Steubenville-Weirton, OH-WV Area Comprising
Brooke and Hancock Counties

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the West Virginia
Department of Environmental Protection (WVDEP) on behalf of the State
of West Virginia. This revision pertains to the West Virginia's plan
for maintaining the 1997 8-hour ozone national ambient air quality
standard (NAAQS) for the West Virginia portion of the Steubenville-
Weirton, OH-WV area (Weirton Area), comprising Brooke and Hancock
Counties. EPA is approving these revisions to the West Virginia SIP in
accordance with the requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on March 22, 2021.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2020-0195. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (CBI) 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 through
https://www.regulations.gov, or please contact the person identified in
the For Further Information Contact section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Keila M. Pag[aacute]n-Incle, Planning
& Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2926. Ms. Pag[aacute]n-Incle can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 29, 2020 (85 FR 38820), EPA published a notice of proposed
rulemaking (NPRM) for the State of West Virginia. In the NPRM, EPA
proposed approval of West Virginia's plan for maintaining the 1997 8-
hour ozone NAAQS through June 13, 2027, in accordance with CAA section
175A. The formal SIP revision was submitted by WVDEP on December 10,
2019.

II. Summary of SIP Revision and EPA Analysis

    On May 14, 2007 (72 FR 27060, effective June 13, 2007), EPA
approved a redesignation request (and maintenance plan) from WVDEP for
the Weirton Area. Per CAA section 175A(b), at the end of the eighth
year after the effective date of the redesignation, the state must also
submit a second maintenance plan to ensure ongoing maintenance of the
standard for an additional 10 years, and in South Coast Air Quality
Management District v. EPA,\1\ the D.C. Circuit held that this
requirement cannot be waived for areas, like the Weirton Area, that had
been redesignated to attainment for the 1997 8-hour ozone NAAQS prior
to revocation and that were designated attainment for the 2008 ozone
NAAQS. CAA section 175A sets forth the criteria for adequate
maintenance plans. In addition, EPA has published longstanding guidance
that provides further insight on the content of an approvable
maintenance plan, explaining that a maintenance plan should address
five elements: (1) An attainment emissions inventory; (2) a maintenance
demonstration; (3) a commitment for continued air quality monitoring;
(4) a process for verification of continued attainment; and (5) a
contingency plan.\2\ WVDEP's December 10, 2019 SIP submittal fulfills
West

Virginia's obligation to submit a second maintenance plan and addresses
each of the five necessary elements.
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    \1\ 882 F.3d 1138 (D.C. Cir. 2018).
    \2\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
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    As discussed in the June 29, 2020 NPRM, consistent with
longstanding EPA guidance,\3\ areas that meet certain criteria may be
eligible to submit a limited maintenance plan (LMP) to satisfy one of
the requirements of CAA section 175A. Specifically, states may meet CAA
section 175A's requirements to ``provide for maintenance'' by
demonstrating that the area's design value \4\ is well below the NAAQS
and that it has had historical stability attaining the NAAQS. EPA
evaluated WVDEP's December 10, 2019 submittal for consistency with all
applicable EPA guidance and CAA requirements. EPA found that the
submittal met CAA section 175A and all CAA requirements, and proposed
approval of the LMP for the Weirton Area, comprising Brooke and Hancock
Counties, as a revision to the West Virginia SIP. The effect of this
action makes certain commitments related to the maintenance of the 1997
8-hour ozone NAAQS federally enforceable as part of the West Virginia
SIP.
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    \3\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas'' from Sally L. Shaver, Office of Air
Quality Planning and Standards (OAQPS), dated November 16, 1994;
``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas'' from Joseph Paisie, OAQPS, dated October 6,
1995; and ``Limited Maintenance Plan Option for Moderate
PM10 Nonattainment Areas'' from Lydia Wegman, OAQPS,
dated August 9, 2001.
    \4\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone nonattainment
area is the highest design value of any monitoring site in the area.
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    Other specific requirements of WVDEP's December 10, 2019 submittal
and the rationale for EPA's proposed action are explained in the NPRM
and will not be restated here.

III. EPA's Response to Comments Received

    EPA received five sets of relevant comments on the June 29, 2020
NPRM, two of which were exact duplicates. All comments received are in
the docket for this rulemaking action. A summary of the comments and
EPA's responses are provided herein.

Comment 1

    The commenter requests that EPA disapprove West Virginia's LMP
``because it fails to show maintenance of the standard for 10 years and
it fails to provide for the protection of health because of the lack of
enforcement'' and also because of a ``lack of reductions in the
Steubenville area.'' The commenter also requests that EPA disapprove
the LMP because EPA has not provided information with regards to ``all
of the areas the agency proposes to monitor.''

Response 1

    EPA disagrees that the LMP should be disapproved based on the
reasons given by the commenter. EPA has determined that the LMP
adequately demonstrates compliance for the second 10 year period in
accordance with CAA section 175A and EPA's longstanding guidance that
establishes the five elements that EPA has determined will ensure
maintenance of the relevant NAAQS for a period of 10 years: (1) An
attainment emissions inventory; (2) maintenance demonstration; (3) a
commitment for continued air quality monitoring; (4) a process for
verification of continue attainment; and (5) a contingency plan.\5\ EPA
determined that West Virginia's second maintenance plan addresses all
the required elements of an approvable maintenance plan. Although the
commenter asserts that the LMP fails to demonstrate maintenance of the
NAAQS, the commenter does not offer any data to contradict the data
that EPA and West Virginia relied upon, nor does the commenter explain
why the data that EPA and West Virginia relied upon does not adequately
demonstrate maintenance of the NAAQS. See, e.g., International
Fabricare Institute v. E.P.A. \6\ (The Administrative Procedures Act
does not require that EPA change its decision based on ``comments
consisting of little more than assertions that in the opinions of the
commenters the agency got it wrong,'' when submitted with no
accompanying data). Because this LMP demonstrates that the
Steubenville-Weirton Area is maintaining the 1997 8-hour ozone NAAQS
and will maintain it for the duration of this LMP based on its historic
and current level of emissions, there is no indication that the Weirton
Area suffers from a ``lack of reductions.'' The Area is required to
obtain additional emissions reductions from the contingency measures
included in its plan, but those measures will only be required to be
implemented if triggered by events indicating that the Area's ability
to maintain the NAAQS is threatened. EPA's approval of this LMP under
the authority of CAA 110 confers upon EPA the authority to enforce the
provisions of this plan, if necessary, in Federal court. Therefore, EPA
disagrees with the commenter that this LMP does not demonstrate
maintenance of the NAAQS and is not enforceable.
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    \5\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
    \6\ 972 F.2d 384 (D.C. Cir. 1992).
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    EPA also disagrees that the LMP should be disapproved because EPA
has not provided information regarding ``all of the areas the agency
proposes to monitor.'' West Virginia currently has an EPA approved
monitoring network to measure compliance with the 8-hour ozone NAAQS
(49 FR 18094, effective June 26, 1984). West Virginia is required to
have this monitoring network for at least the duration of the second
maintenance plan \7\ and cannot change it without EPA's approval, see
40 CFR 58.14(a). The monitors are currently located in Hancock County,
West Virginia and in Jefferson County, Ohio.\8\ If the monitoring
locations need to change, EPA will approve those changes only if the
new locations will continue to monitor compliance with the 8-hour ozone
NAAQS for the Weirton Area, see 40 CFR 58.10(a). This information was
available to the public through EPA's prior rulemakings cited
previously in this document, and therefore there is no lack of
information for the public regarding ``all of the areas the agency
proposes to monitor'' regarding the Weirton Area. The commenter
therefore provides no basis for EPA to change its approval of the LMP
for the Weirton Area.
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    \7\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas'' from Sally L. Shaver, Office of Air
Quality Planning and Standards (OAQPS), dated November 16, 1994;
``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas'' from Joseph Paisie, OAQPS, dated October 6,
1995; and ``Limited Maintenance Plan Option for Moderate
PM10 Nonattainment Areas'' from Lydia Wegman, OAQPS,
dated August 9, 2001.
    \8\ See 71 FR 57905 (October 2, 2006) and the following
documents included in this rule's docket: West Virginia's ``2020
Ambient Air Monitoring Annual Network Plan and SO2 Data
Requirement Rule Annual Report'' and Appendix D of Ohio EPA's
``2020-2021 Ohio EPA Air Monitoring Network Plan.''
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Comment 2

    The commenter claims that the LMP does not ``address the critical
public health threats posed by high levels of toxic air pollution'' in
the Weirton Area. The commenter alleges that the LMP should not be
approved based on a letter that the commenter states was submitted by
the American Lung Association (ALA) to Ohio EPA, in which the ALA
identified the ``Steubenville Plan'' to be ``short-sighted, and could
endanger the health and safety of thousands of residents in the
nonattainment area.'' Further, the commenter also contends that the LMP
was approved ``without an Environmental Effects Statement and an

environmental review,'' and EPA cannot approve ``until a statement and
review are completed and proposed to the public at large.''

Response 2

    The commenter has misapprehended the purpose of West Virginia's
second maintenance plan for the 1997 8-hour ozone NAAQS and the
criteria for EPA's approval of that plan. As stated in the NPRM, on
December 10, 2019, West Virginia submitted a SIP revision for a second
maintenance plan for the 1997 8-hour ozone NAAQS which focuses on
meeting requirements under CAA section 175A, to which EPA has published
longstanding guidance that provides the necessary criteria for an
approvable maintenance plan.
    The commenter states that EPA should disapprove the LMP based on a
letter submitted to Ohio EPA by the ALA. Neither the commenter nor the
ALA has submitted that letter to EPA, and whether the letter is
relevant to the LMP or some other ``Steubenville Plan'' that is not
before EPA is unclear. To the extent that the comment in general terms
asserts that the LMP should not be approved due to air quality issues
in Steubenville, EPA relies on the analysis in the NPRM, and its
response to Comment 1, that this LMP meets the criteria for approval as
it adequately demonstrates that the area will maintain the relevant
NAAQS for the duration of the plan, contains all required elements of
an approvable plan, and the commenter does not offer any data to
contradict the data that EPA and West Virginia relied upon, nor does
the commenter explain why the data that EPA and West Virginia does not
adequately demonstrate maintenance of the NAAQS. See, e.g.,
International Fabricare Institute v. E.P.A.\9\. Therefore, EPA
disagrees this comment provides a basis for disapproving this LMP.
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    \9\ 972 F.2d 384 (D.C. Cir. 1992).
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    The commenter additionally states that West Virginia's LMP was
approved ``without an Environmental Effects Statement and an
environmental review.'' EPA is unfamiliar with these terms in respect
to rulemaking conducted under the Federal Administrative Procedures Act
(APA),\10\ the CAA or its implementing regulations relevant to this
rulemaking. To the extent the commenter appears to be alleging a defect
in West Virginia's process for developing and approving this LMP West
Virginia submitted to EPA ``[e]vidence that the State followed all of
the procedural requirements of the State's laws and constitution in
conducting and completing the adoption/issuance of the plan,\11\ which
is in the docket for this rulemaking.'' \12\ To the extent that the
comment is directed at EPA's rulemaking on this LMP, EPA has followed
all requirements of the APA, the CAA, and regulations thereunder
relevant to this rulemaking. There is no requirement under the APA, the
CAA, or its implementing regulations for anything or process called an
``Environmental Effect statement'' or ``environmental review.'' This
comment therefore provides no basis for EPA to disapprove this LMP.
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    \10\ 5 U.S.C. 551 et seq.
    \11\ 40 CFR part 51, Appendix V, 2.1(e).
    \12\ See ``Weirton WV State Submittal'' and ``Weirton, WV
Completeness Letter'' of WVDEP's December 10, 2019 submittal. The
``Weirton WV State Submittal'' states that the SIP revision includes
documentation that proper administrative procedural requirements
have been followed. In addition, the ``Weirton, WV Completeness
Letter,'' certifies that EPA has determined that the submittal is
administratively and technically complete and EPA will proceed to
review the SIP submission.
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Comment 3

    The commenter asserts that the LMP should not be approved because
of EPA's reliance on the Air Quality Modeling Technical Support
Document (TSD) that was developed for EPA's regional transport
rulemaking. The commenter contends that: (1) The TSD shows maintenance
of the area for three years and not 10 years; (2) the modeling was
performed for transport purposes across state lines and not to show
maintenance of the NAAQS; (3) the modeling was performed for the 2008
and 2015 ozone NAAQS and not the 1997 ozone NAAQS; (4) the TSD has been
``highly contested'' by environmental groups and that ``other states
contend EPA's modeling as flawed;'' and (5) the TSD does not address a
recent court decision that threw out EPA's modeling ``because it
modeled to the wrong attainment year. . . .'' The commenter asserts
that the four specific issues it raises with respect to the modeling
means that the TSD is ``flawed, illegal, [and] is being used improperly
for the wrong purpose. . . .'' The commenter states that ``EPA must
retract its reliance on the modeling for the purposes of this
maintenance plan and must find some other way of showing continued
maintenance of the 1997 ozone NAAQS.''

Response 3

    EPA does not agree with the commenter that approval of West
Virginia's second maintenance plan is not appropriate. The commenter
raises concerns about West Virginia and EPA's citation of Air Quality
Modeling TSD, but the commenter ignores that EPA's primary basis for
finding that West Virginia has provided for maintenance of the 1997 8-
hour ozone NAAQS in the Weirton Area is the State's demonstration that
the criteria for a LMP has been met. See 85 FR 38820, June 29, 2020.
Specifically, as stated in the NPRM, for decades EPA has interpreted
the provision in CAA section 175A that requires states to ``provide for
maintenance'' of the NAAQS to be satisfied where areas demonstrate that
design values are and have been stable and well below the NAAQS--e.g.,
at 85% of the standard, or in this case at or below 0.071 parts per
million (ppm). EPA calls such demonstration a ``limited maintenance
plan.''
    The modeling cited by the commenter was referenced in West
Virginia's submission and as part of EPA's proposed approval as
supplementary supporting information, and we do not agree that the
commenter's concerns about relying on that modeling are warranted. The
commenter contends that the modeling only goes out three years (to
2023) and it needs to go out to 10 years, and therefore may not be
relied upon. However, the Air Quality Modeling TSD was only relied upon
by EPA to provide additional support to indicate that the area is
expected to continue to attain the NAAQS during the relevant period. As
noted previously, West Virginia primarily met the requirement to
demonstrate maintenance of the NAAQS by showing that they met the
criteria for an LMP, rather than by modeling or projecting emissions
inventories out to a future year. We also do not agree that the State
is required to demonstrate maintenance for 10 years; CAA section 175A
requires the State to demonstrate maintenance through the 20th year
after the area is redesignated, which in this case is 2027.
    We also disagree with the commenter's contention that because the
Air Quality Modeling TSD was performed to analyze the transport of
pollution across state lines with respect to other ozone NAAQS, it
cannot be relied upon in this action. We acknowledge that the Air
Quality Modeling TSD at issue was performed as part of EPA's efforts to
address interstate transport pollution under CAA section
110(a)(2)(D)(i)(I). However, the purpose of the Air Quality Modeling
TSD is fully in keeping with the question of whether West Virginia is
expected to maintain the NAAQS. The Air Quality Modeling TSD identifies
which air quality monitors in the United States are projected to have
problems attaining or maintaining the 2008 and

2015 NAAQS for ozone in 2023. Because the Air Quality Modeling TSD
results simply provide projected ozone concentration design values,
which are expressed as three-year averages of the annual fourth high 8-
hour daily maximum ozone concentrations, the modeling results are
useful for analyzing attainment and maintenance of any of the ozone
NAAQS that are measured using this averaging time; in this case, the
1997, 2008 and 2015 ozone NAAQS. The only difference between the three
standards is stringency. Taking the Weirton Area's most recent
certified design value as of the proposal (i.e., for the years 2016-
2018), the area's design value was 0.065 ppm. What we can discern from
this is that the Weirton Area is meeting the 1997 8-hour ozone NAAQS of
0.080 ppm, the 2008 ozone NAAQS of 0.075 ppm, and the 2015 ozone NAAQS
of 0.070 ppm. The same principle applies to projected design values
from the Air Quality Modeling TSD. In this case, the interstate
transport modeling indicated that in 2023, the Weirton Area's design
value is projected to be 0.060 ppm, which is again, well below all
three standards. The fact that the Air Quality Modeling TSD was
performed to indicate whether the area will have problems attaining or
maintaining the 2015 ozone NAAQS (i.e., 0.070 ppm) does not make the
modeling less useful for determining whether the area will also meet
the less stringent revoked 1997 standard (i.e., 0.080 ppm).
    The commenter asserts that many groups have criticized EPA's
transport modeling, alleging that the agency used improper emissions
inventories, incorrect contribution thresholds, wrong modeling years,
or that EPA has not accounted for local situations or reductions that
occurred after the inventories were established. The commenter also
alleges that EPA should not rely on its modeling because it ``fails to
stand up to the recent court decisions,'' citing the Wisconsin v. EPA
D.C. Circuit decision. EPA disagrees that the existence of criticisms
of the agency's Air Quality Modeling TSD render it unreliable, and we
also do not agree that anything in recent court decisions, including
Wisconsin v. EPA, suggests that EPA's Air Quality Modeling TSD is
technically flawed. We acknowledge that the source apportionment air
quality modeling runs cited by the commenter have been at issue in
various legal challenges to EPA actions, including the Wisconsin v. EPA
case.\13\ However, in that case, the only flaw in EPA's Air Quality
Modeling TSD identified by the D.C. Circuit was the fact that its
analytic year did not align with the attainment date found in CAA
section 181.\14\ Contrary to the commenter's suggestion, the D.C.
Circuit upheld EPA's Air Quality Modeling TSD with respect to the many
technical challenges raised by petitioners in the Wisconsin case.\15\
We therefore think reliance on the interstate transport Air Quality
Modeling TSD as supplemental support for showing that the Weirton Area
will maintain the 1997 8-hour ozone NAAQS through the end of its 20th-
year maintenance period is appropriate.
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    \13\ 938 F.3d 303 (D.C. Cir. 2019).
    \14\ Id. at 313.
    \15\ Wisconsin, 938 F.3d at 323-331.
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Comment 4

    The commenter asserts that EPA should disapprove this maintenance
plan because EPA should not allow states to rely on emission programs
such as the Cross-State Air Pollution Rule (CSAPR) to demonstrate
maintenance for the 1997 ozone NAAQS. The commenter alleges that ``the
CSAPR and CSAPR Update and CSAPR Close-out rules were vacated
entirely'' by multiple courts and ``are now illegal programs providing
no legally enforceable emission reductions to any states formerly
covered by the rules.'' The commenter also asserts that nothing
restricts ``big coal and gas power plants from emitting way beyond
there (sic) restricted amounts.'' The commenter does allow that ``If
EPA can show that continued maintenance without these rules is possible
for the next 10 years then that would be OK but as the plan stands it
relies on these reductions and must be disapproved.''

Response 4

    The commenter has misapprehended the factual circumstances
regarding these interstate transport rules. Every rule cited by the
commenter that achieves emission reductions from electric generating
units (EGUs or power plants)--i.e., the Cross-State Air Pollution Rule
and the CSAPR Update--remains in place and continues to ensure emission
reductions of nitrogen oxides (NOX) and sulfur dioxide
(SO2). CSAPR began implementation in 2015 (after it was
largely upheld by the Supreme Court) and the CSAPR Update began
implementation in 2017. The latter rule was remanded to EPA to address
the analytic year issues discussed in the prior comment and response,
but the rule remains fully in effect. The commenter is correct that the
D.C. Circuit vacated the CSAPR close-out, but we note that that rule
was only a determination that no further emission reductions were
required to address interstate transport obligations for the 2008 ozone
NAAQS; the rule did not itself establish any emission reductions. We
therefore disagree that the legal status of these rules presents any
obstacle to EPA's approval of West Virginia's submission.

IV. Final Action

    EPA is approving the 1997 8-hour ozone NAAQS limited maintenance
plan for the Steubenville-Weirton, OH-WV area (Weirton Area),
comprising Brooke and Hancock Counties as a revision to the West
Virginia SIP.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because it is not a significant regulatory
action under Executive Order 12866;
     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 located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    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 April 19, 2021. 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 pertaining to West Virginia's limited maintenance plan
for the Steubenville-Weirton, OH-WV area (Weirton Area), comprising
Brooke and Hancock Counties 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, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: February 8, 2021.
Diana Esher,
Acting Regional Administrator, Region III.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 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 XX--West Virginia

0
2. In Sec.  52.2520, the table in paragraph (e) is amended by adding
the entry ``1997 8-Hour Ozone National Ambient Air Quality Standard
Second Maintenance Plan for the West Virginia Portion of the
Steubenville-Weirton, OH-WV Area Comprising Brooke and Hancock
Counties'' at the end of the table to read as follows:

Sec.  52.2520  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                                            State
    Name of non-regulatory SIP          Applicable        submittal     EPA approval date        Additional
             revision                 geographic area        date                                explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
1997 8-Hour Ozone National         Steubenville-            12/10/19  2/18/2021, [insert
 Ambient Air Quality Standard       Weirton, OH-WV Area                Federal Register
 Second Maintenance Plan for the    Comprising Brooke                  citation].
 West Virginia Portion of the       and Hancock
 Steubenville-Weirton, OH-WV Area   Counties.
 Comprising Brooke and Hancock
 Counties.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-03027 Filed 2-17-21; 8:45 am]
BILLING CODE 6560-50-P


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[BASF Corporation]

[Insert petition number]

	EPA has received a pesticide petition ([----------]) from [BASF Corporation], [26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709-3528] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by amending the established tolerance for residues of the fungicide [Fluxapyroxad, (BAS 700 F); 1H-Pyrazole-4-carboxamide,3-(difluoromethyl)-1-methyl-N-(3',4',5'-triflu oro[1,1'-biphenyl]-2-yl)-, its metabolites, and degradates] in or on the following raw agricultural commodities: [Fruit, stone, group 12] at [3.0] parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.[Nature of the residue studies were conducted in wheat, soybean and tomato as representative crops in order to characterize the fate of fluxapyroxad (BAS 700 F) in all crop matrices. Two radiocarbon labels were studied in each crop, with 14-C labels positioned in aniline and pyrazole ring structures. Fluxapyroxad was the predominant residue in most crops.  In all crops the fluxapyroxad Residues of Concern (ROC) were characterized as parent fluxapyroxad plus metabolites M700F048 and M700F002. A confined rotational crop study added metabolite M700F008 and confirmed that parent fluxapyroxad plus metabolites M700F008, M700F048 and M700F002 were the residues of concern in the representative rotational crops of wheat, radish, and spinach.]

	2. Analytical method. [Independently validated analytical methods have been submitted for analyzing residues of parent fluxapyroxad (BAS 700 F) plus metabolites M700F008, M700F048 and M700F002 with appropriate sensitivity in/on stone fruits (group 12) crops, represented by cherry, peach, and plum for which tolerances have been established.]

	3. Magnitude of residues. [Field trials were carried out to determine the magnitude of the residue in/on Cherry, Peach, and Plums. The data were used to establish a tolerance of 2 ppm for fluxapyroxad (BAS 700 F) residues in/on the stonefruit crop group 12 commodities.  For the European Union (EU) import MRL application for cherries, two (2) additional residue trials were conducted to complete the requirements.  However, over-tolerance fluxapyroxad residues were confirmed in some cherry samples which require amendment of the established tolerance for the stonefruit crop group 12. The number and locations of field trials are in accordance with OPPTS Guideline 860.1500. Field trials were carried out using the maximum label rates, the maximum number of applications, and the minimum pre-harvest interval (PHI) for all the crops. Residues of M700F048 and M700F002 were generally less than the limit of quantitation and often less than the limit of detection. Residues of M700F008 were significantly less than residues of fluxapyroxad.  Detected residues of fluxapyroxad in all crops support the proposed tolerance based on parent fluxapyroxad. The impact of the amended tolerance on the animal Maximum Reasonably Balanced Diets was insignificant, and thus no changes in tolerances in animal commodities are proposed.]

B. Toxicological Profile

	1. Acute toxicity.  [Fluxapyroxad (BAS 700 F) displayed low acute toxicity via the oral, dermal and inhalation routes of exposure.  It was not irritating to the eyes, only slightly irritating to the skin, and not a dermal sensitizer. The acute toxicity studies place technical fluxapyroxad in toxicity category III for acute oral and dermal and category IV for acute inhalation, eye and skin irritation.  Fluxapyroxad  is not a dermal sensitizer.]

	2. Genotoxicty. [Fluxapyroxad (BAS 700 F) was not genotoxic in a battery of assays. Fluxapyroxad was negative for inducing mutations in bacterial and mammalian cell assays. No evidence of a clastogenic effect was observed in vitro or in vivo, and fluxapyroxad did not cause unscheduled DNA synthesis in hepatocytes of treated rats.]

	3. Reproductive and developmental toxicity. [The reproductive and developmental toxicity of fluxapyroxad (BAS 700 F) was investigated in a 2-generation rat reproduction study as well as in rat and rabbit developmental toxicity studies. In the reproduction study, there were no effects on fertility, up to the highest dose tested of 300 mg/kg bw/d. At the high- and mid- (50 mg/kg bw/d) doses tested, fluxapyroxad administration resulted in decreased food consumption, impaired body weight development, clinical chemistry and select organ weight changes and histopathology. Impairment of pup body weight development was also seen at these doses. The NOAEL for systemic and developmental toxicity was 10 mg/kg bw/day.

In the rat developmental toxicity study, slight maternal toxicity was observed at the high dose level of 1000 mg/kg bw/d, in the form of limited clinical chemistry, liver and thyroid weight effects, and thyroid histopathology. No evidence of developmental toxicity was observed in the rat up to the highest dose tested of 1000 mg/kg bw/d.

At the highest dose tested in the rabbit teratology study (60 mg/kg bw/d), maternal toxicity consisted of clinical signs, abortion, reduced food consumption, and impaired body weight development. The only developmental effect at the high dose, which caused substantial maternal toxicity, consisted of a commonly observed, reversible external variation, paw hyperflexion. Based on the effects described, the maternal and developmental NOAEL in rabbits was 25 mg/kg bw/d.]

	4. Subchronic toxicity. [The principal target organ in all studies in rats, mice and dogs was the liver, as indicated by organ weight changes and altered clinical chemistry parameters, which were consistent with liver enzyme induction. Histopathological changes in the liver were only evident in rats. The thyroid was also identified as a target organ in rats, as indicated by organ weight changes, histopathology and thyroid hormone changes. The lowest NOAEL in subchronic oral toxicity studies was approximately 7.3 mg/kg bw/day in the rat 90-day study.

No systemic toxicity was observed in a 28-day repeat dose dermal toxicity study at doses as high as 1000 mg/kg bw/day.

The neurotoxic potential of fluxapyroxad (BAS 700 F) was studied following both acute and subchronic oral administration in the rat. In the acute study, treatment-related neurobehavioral effects were noted in mid and high dose animals on the day of treatment. These consisted of slight increases of the landing foot-splay in high dose males, reduction in the number of rearings in males, and impaired motor activity in high and mid dose males and females. No effects on these parameters were observed on study days 7 and 14. Additionally, no treatment-related neuropathological findings (brain weight changes, neurohistopathological findings) were observed. Therefore, the affected parameters indicated a neuropharmacological effect rather than neuronal damage. Based on the results of this study the NOAEL for acute neurotoxicity was 125 mg/kg bw/d in male and female rats.

There was no indication of clinical (general clinical observation, FOB and motor activity) or neurohistopathological neurotoxicity in a subchronic neurotoxicity study. Systemic signs of toxicity were consistent with those seen in repeated dose studies with fluxapyroxad. Under the conditions of the present study the no observed adverse effect level (NOAEL) for neurotoxicity was 5000 ppm (approximately 320 mg/kg bw/d), the highest dose tested.]

	5. Chronic toxicity. [Systemic toxicity in long term oral exposure studies in dogs, mice and rats included effects on food consumption, body weight development and clinical chemistry changes. The liver was identified as the main target organ in all species tested, as indicated by liver weight changes and non-neoplastic lesions. Additional target organs in the rat included the thyroid and bones. The spleen, gall bladder and prostate were affected in dogs.

Fluxapyroxad (BAS 700 F) was not carcinogenic in C57BL mice following continuous dietary administration for 18 months at dietary concentrations up to 6000 ppm (approximately 1000 mg/kg bw/d). Treatment of fluxapyroxad for 2 years in rats resulted in the induction of hepatocellular tumors in males at dose levels ≥ 250 ppm and in females at ≥ 1500 ppm. A mitogenic, Phenobarbital-like mechanism is proposed as the probable mode of action for liver tumor development in rats. This was supported by mechanistic studies on enzyme induction and S-Phase response in the liver, and indicates there is a threshold for tumor development and a margin of exposure cancer risk assessment is appropriate.

In the rat chronic/oncogenicity study, the NOAEL in males and females was 50 ppm (2.1 and 2.7 mg/kg bw/day, respectively). NOAEL’s in the mouse oncogenicity study were 150 ppm in males (21 mg/kg bw/day) and in females (33 mg/kg bw/day).  In a chronic dog study, the NOAEL was 300 ppm (approximately 8 mg/kg bw/day).]

	6. Animal metabolism. [The rat, goat and hen metabolism studies were conducted to determine the nature of the fluxapyroxad (BAS 700 F) residues in animals. Studies were conducted with radiolabeled fluxapyroxad with 14-C labels positioned in aniline and pyrazole ring structures (hen metabolism, aniline ring label only). BAS 700 F was either excreted  rapidly in urine and feces or transformed to a number of metabolites after administration to animals. All relevant metabolites were identified. Unchanged parent compound was found as the predominant component in most animal matrices. The metabolism of fluxapyroxad in the animals is well understood. Degradation proceeds via N-demethylation of the pyrazole ring and/or hyroxylation of the biphenyl ring followed by subsequent O- and N-conjugation reactions to produce metabolites that are rapidly excreted, along with parent, and do not readily accumulate in tissues or milk. Residues in milk and most edible tissues are low. The same metabolic reactions were observed in each of the animals studied, so there is a consistent metabolic pathway for fluxapyroxad in animals.  Rat, goat and hen metabolism studies were also conducted with radiolabeled M700F048, a N-glucoside of N-desmethyl BAS 700F, a plant metabolite, seen at levels >10 TRR in soybean seed in the plant metabolism study.  In all animals, the glucoside was readily hydrolyzed to generate M700F008, a key intermediate in the metabolism of fluxapyroxad in animals. The radiolabeled residue was rapidly excreted with little uptake in tissue, following a metabolic pathway in all animals like that for fluxapyroxad.  Rat, goat and hen metabolism studies were also conducted with radiolabeled M700F002, a carboxylic acid attached to the pyrazole-ring formed by cleavage of the fluxapyroxad carboxamide bond.  M700F002 was seen at levels >10 TRR in soybean seed in the plant metabolism and was present only at low levels in the rat urine.  In all animal studies, M700F002 was not metabolized and was almost completely and rapidly excreted unchanged, with no uptake in tissue.]

	7. Metabolite toxicology. [The metabolism of fluxapyroxad (BAS 700 F) is similar in plants and mammals.  The metabolism of fluxapyroxad, both in plants and animals, is largely based on two key transformation reactions, N-demethylation of the pyrazole moiety and hydroxylation of the biphenyl moiety.  Both reactions, combinations thereof, and subsequent conjugation reactions (e.g. glucose, glucuronic acid, cysteine) result in a range of common and structurally related compounds.  Due to the similar structural nature of most metabolites, the toxicity of most plant metabolites is adequately estimated from the results of studies performed with fluxapyroxad in animals. In addition, the metabolism of metabolites M700F002, and M700F048 were each investigated in rat, goat and hen. Animal metabolism studies were performed with M700F002 since the plant metabolite was seen in the rat metabolism only at low levels in urine. In rat, goat and hen, M700F002 is rapidly and almost completely excreted unchanged with almost no uptake in tissue, milk or eggs.  M700F002 is not metabolized in animal to any significant extent.

Animal metabolism studies were performed with M700F048, a glucoside conjugate since the plant metabolite would not be formed in animal metabolism. In animal metabolism studies, M700F048 was rapidly hydrolyzed to metabolite M700F008, a key metabolite in the metabolic pathway of fluxapyroxad. Unchanged M700F048 was not detected in edible animal commodities.

Toxicology studies (Acute oral toxicity, Ames test, in vitro mutagenicity test in mammalian cells, in vitro chromosome aberration test, in vivo mouse micronucleus, 28/90-day rat feeding and developmental toxicity in rabbits) were conducted on three metabolites. Overall, M700F001, M700F002 and M700F048 are of low acute and subchronic toxicity in rats. The metabolites showed no genotoxic potential in a battery of genotoxicity studies. In addition, no adverse effects were observed up to the highest doses tested in developmental toxicity study with rabbits.]

	8. Endocrine disruption. [No specific tests have been conducted with fluxapyroxad (BAS 700 F) to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.  However, there were no significant findings in other relevant toxicity studies (e.g., sub-chronic and chronic toxicity, developmental toxicity and multi-generation reproductive studies) which would suggest that fluxapyroxad produces any endocrine disruption.]

C. Aggregate Exposure

	1. Dietary exposure. [The tolerance expression for dietary risk assessment is fluxapyroxad (BAS 700 F) and M700F008 in plant and animal commodities except milk, for which M700F010 is also included.  Exposure assessments were conducted to evaluate the potential risk due to acute and chronic dietary exposure of the U.S. population and all sub-populations. The assessments included all current established tolerances, pending tolerances, the crop commodities proposed for tolerances, and animal matrices including egg, milk and cream.]

	i. Food. [Acute Dietary Exposure Assessment

Acute dietary exposure estimates were based on (a) tolerance values on crops approved as of May 14, 2012 with the factor of 1.5 that was used in the acute dietary assessment conducted as part of the evaluation by EPA (a few input values were changed as discussed below);  (b) proposed tolerance values for crops for which tolerances are pending, and crops included in this submission. A 1.5 factor was not used to adjust the tolerances for the new commodities used in the assessment since the levels of metabolite M700F008 were always much less than 50% of the tolerance.  The analysis assumed 100% of all crops treated.  Values changed from the EPA dietary analysis of February 2012 are soybean seed commodities changed from 0.75 mg/kg to 0.15 mg/kg, sweet corn changed from 0.015 to 0.15 mg/kg and rice commodities to reflect new pending rice use. The impact of the new commodities on the animal Maximum Reasonably Balanced Diets was minimal and thus no changes in tolerances in animal commodities are proposed.

For drinking water all fluxapyroxad (BAS 700 F) uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest acute water concentration occurred from the rice use scenario.  The highest acute Estimated Drinking Water Concentrations (EDWC) for BAS 700 F were estimated to be 26.1 µg/L (ppb) in surface water.   The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0261 mg/L based on the surface water concentration determined for the pending use in rice.

The consumption data was from the NHANES 2-day food consumption data for 2003 to 2008 and the assessment was performed using the Dietary Exposure Evaluation Module (DEEM-FCID) software.

The resulting exposure estimates were compared against the fluxapyroxad (BAS 700 F) acute Population Adjusted Dose (aPAD) of 1.25 mg/kg b.w./day for all populations. The endpoint is based on the NOAEL of 125 mg/kg/day with an FQPA safety factor of 1.  The most highly exposed sub-population was children 1-2 years old with 8.9 % utilization of the aPAD. The results of the acute dietary assessment are presented in Table 1.

Table 1. Results for fluxapyroxad (BAS 700 F) Acute Dietary Exposure (Food and Water) Considering all Current and Proposed Tolerances using DEEM-FCID at the 95th Percentile

Population	Exposure Estimate	% aPAD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.047194	3.8

All Infants (< 1 year old)	0.090603	7.2

Children (1-2 years old)	0.111309	8.9

Children (3-5 years old)	0.090178	7.2

Children (6-12 years old)	0.047793	3.8

Youth (13-19 years old)	0.031709	2.5

Adults (20-49 years old)	0.039777	3.2

Adults (50+ years old)	0.03779	3.0

Females (13-49 years old)	0.039958	3.2

The results of the analysis show that for all populations, the estimated exposures are well below the Agency's level of concern (< 100% aPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values.

Chronic Dietary Exposure Assessment

The chronic dietary exposure estimates were based on combined residues of the highest average field trial (HAFT) values for parent and HAFT values for residues of M700F008 for all registered raw agricultural commodities and all newly proposed raw agricultural commodities except for the use of the mean residue values of fluxapyroxad (BAS 700 F) and HAFT values for residues of M700F008 for the commodities of barley, buckwheat, millet, oat, and rice.  Processing factors for apple juice (0.2), apple sauce (0.25), potato dry granules (1.17), sugarcane refined sugar (0.04) and molasses (0.16) as determined in processing studies were used.  Some other changes were made to values used in the EPA evaluation of February 2012 in that apricot and nectarine residues were set equal to peach residues, rye and triticale residues were set equal to wheat residues and sweet corn was set to 0.15 mg/kg rather than 0.01 mg/kg.

For drinking water all fluxapyroxad (BAS 700 F) uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest chronic water concentration occurred from the use in paddy rice scenario.  The highest chronic EDWC’s for BAS 700F were estimated to be 23.623 µg/L in surface water. The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0236 mg/L based on the surface water concentration determined for the use in paddy rice.

The consumption data was from the NHANES 2-day food consumption data for 2003 to 2008 and the assessment was performed using the Dietary Exposure Evaluation Module (DEEM-FCID) software.

The chronic Population Adjusted Dose (cPAD) used for U.S. population and all sub-populations is 0.021 mg/kg bw/day. This endpoint is based on the NOAEL value of 2.1 mg/kg bw/day using a FQPA safety factor of 1.  The most highly exposed population sub-group was children 1-2 years of age which utilized 70.3% cPAD.  The results of the chronic dietary assessment are presented in Table 2.

Table 2.  Results for fluxapyroxad (BAS 700 F) Chronic Dietary Exposure (Food and Water) Considering All  Commodities using DEEM-FCID

Population	Exposure Estimate	% cPAD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.005725	27.3

All Infants (< 1 year old)	0.009033	43.0

Children (1-2 years old)	0.014769	70.3

Children (3-5 years old)	0.011421	54.4

Children (6-12 years old)	0.006514	31.0

Youth (13-19 years old)	0.003794	18.1

Adults (20-49 years old)	0.004983	23.7

Adults (50+ years old)	0.005376	25.6

Females (13-49 years old)	0.005047	24.0

The results of the risk assessment show that for all populations the exposures are below a level of concern (< 100% cPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values.]

	ii. Drinking water. [The consumption of fluxapyroxad (BAS 700 F) residues in drinking water was included in the dietary assessments above. For drinking water all fluxapyroxad uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest acute and chronic water concentration occurred from the rice use scenario.  The highest acute Estimated Drinking Water Concentrations (EDWC) for fluxapyroxad were estimated to be 26.1 µg/L (ppb) in surface water.  The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0261 mg/L based on the surface water concentration determined for the use in rice.

The highest chronic water concentration occurred from the use in paddy rice. The     highest chronic EDWC’s for fluxapyroxad (BAS 700 F) were estimated to be 23.623 µg/L in surface water. The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0236 mg/L based on the surface water concentration determined for the use in paddy rice.

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water, and residential)

Short- and intermediate-term aggregate risk assessments include exposure from food, water, and residential uses.  Fluxapyroxad (BAS 700 F) i\hss been proposed for registration for use on residential turf.  Because no dermal hazard of concern was identified for fluxapyroxad only inhalation exposure was assessed for residential handlers, and incidental ingestion was assessed for activities of children on treated turf.

The short-term oral NOAEL is 9.0 mg/kg bw/day and the intermediate-term NOAEL is 7.3 mg/kg bw/day.  The short-term aggregate risk assessment is presented in Table 3 and the intermediate-term aggregate risk assessment is presented in Table 4.

Table 3:  Short-Term Aggregate Exposure and Risk for fluxapyroxad (BAS 700 F)

Sub-Populations	Short-term Aggregate

 	Food + water exp. (mg/kg bw/day)	Residential exp (mg/kg bw/day)	Total exp (mg/kg bw/day)	MOE

US Population	0.005725	0.000000	0.005725	1572

Children 1-2 years old	0.014769	0.021385	0.036154	249

Table 4:  Intermediate-Term Aggregate Exposure and Risk for BAS 700 F

Sub-Populations	Intermediate-Term Aggregate

 	Food + water Exp. (mg/kg bw/day)	Residential Exp. (mg/kg bw/day) Total Exp. (mg/kg bw/day)	MOE

US Population	0.005725	0.000000	0.005725	1275

Children 1-2 years old	0.014769	0.021385	0.036154	202

The aggregate MOEs for dietary (food + water) and residential exposures are 202 and 249 for children 1-2 years old and 1275 and 1572 for the general US population.  These MOE values indicate that aggregate risk from the use of BAS 700 F is not a concern.]

	2. Non-dietary exposure.

[A residential exposure and risk assessment was conducted for the proposed residential use of fluxapyroxad (BAS 700 F) products for disease control in turf. Because no dermal hazard of concern was identified for fluxapyroxad, only inhalation exposure was assessed for residential handlers, and incidental ingestion was assessed for activities of children on treated turf. In all exposure scenarios, the MOEs for residential use of fluxapyroxad were well above EPA’s level of concern (MOE < 100) indicating that these exposures are not of concern.

The combined post-application exposure for children 1 to <2 years old was estimated using highly conservative assumptions including: a) basing the transferable residue on the seasonal maximum application rate; b) combining all sources of incidental exposure; c) using EPA default values for children’s activities. With these highly conservative assumptions the incidental exposure was calculated to be 0.021385 mg/kg/day, resulting in short- and intermediate-term MOEs of 420 and 341, respectively.]

D. Cumulative Effects ["Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information'' concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluxapyroxad (BAS 700 F). For the purposes of this tolerance action, therefore, BASF has not assumed that fluxapyroxad has a common mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to the general population from the aggregate exposure to fluxapyroxad (BAS 700 F) from the proposed increase in tolerance for the stonefruit crops, group 12.]

	2. Infants and children. [Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to infants or children from the aggregate exposure to fluxapyroxad (BAS 700 F) from the proposed increase in tolerance for stonefruit crops, group 12.]

F. International Tolerances

	[European Maximum Residue Limits (MRL) were established for fluxapyroxad on multiple crops in October 2011 [Commission Regulation (EU) No 978/2011 of 3 October 2011; MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2011; 9(6):2196 [68 pp.].]

Health Canada Pest Management Regulatory Agency (PMRA) has published Maximum Residue Limits (MRL) for fluxapyroxad residues on multiple crop commodities. A complete list can be found on the Maximum Residue Limits for Pesticides webpage in the Pesticides and Pest Management section of Health Canada’s website.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) established an MRL of 0.1 ppm on barley and all other crops grown in Australia. The Food Standards Australia New Zealand also proposed an MRL of 2 mg/kg (ppm) on stone fruits [except plums (including prunes)] for the purpose of harmonizing MRLs with the U.S.

There are no CODEX maximum residue levels established for residues of fluxapyroxad (BAS 700 F) in/on stone fruits (group 12). Several crops, including stonefruits, were nominated for inclusion on the 2011 tentative CODEX evaluation schedule and the Data Directory for fluxapyroxad was submitted for the 2012 Joint Meeting on Pesticide Residues (JMPR).

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[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Notices]
[Page 37033]
[FR Doc No: 2015-15815]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Form ADV-E.
    [OMB Control No. 3235-0361, SEC File No. 270-318]

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Form ADV-E (17 CFR 279.8) is the cover sheet for certificates of
accounting filed pursuant to rule 206(4)-2 under the Investment
Advisers Act of 1940 (17 CFR 275.206(4)-2). The rule further requires
that the public accountant file with the Commission a Form ADV-E and
accompanying statement within four business days of the resignation,
dismissal, removal or other termination of its engagement. Respondents
each spend approximately three minutes, annually, complying with the
requirements of the form.
    The estimate of burden hours set forth above is made solely for the
purposes of the Paperwork Reduction Act and is not derived from a
comprehensive or even representative survey or study of the cost of
Commission rules and forms.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication. An agency may not conduct or sponsor a
collection of information unless it displays a currently valid OMB
control number. No person shall be subject to any penalty for failing
to comply with a collection of information subject to the PRA that does
not display a valid OMB control number.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: June 23, 2015.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-15815 Filed 6-26-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 239 (Friday, December 12, 2014)]
[Notices]
[Pages 73946-73948]
[FR Doc No: 2014-29152]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2014-0021]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA confirms its decision to exempt 78 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on October 21, 2014. The
exemptions expire on October 21, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

II. Background

    On September 18, 2014, FMCSA published a notice of receipt of
Federal diabetes exemption applications from 78 individuals and
requested comments from the public (79 FR 56107). The public comment
period closed on October 20, 2014, and four comments were received.
    FMCSA has evaluated the eligibility of the 78 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

III. Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 78 applicants have had ITDM over a range of 1 to 48 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the September 18, 2014, Federal
Register notice and they will not be repeated in this notice.

IV. Discussion of Comments

    FMCSA received four comments in this proceeding. The comments are
discussed below.
    Gregory Witt believes that drivers should be granted an exemption
if a doctor is satisfied that their diabetes is adequately controlled
by medication.
    Ashley Warren opposes the ruling in FMCSA-2014-0021 because she
does not believe drivers are required to receive medical examinations
more than every two years. As described in ``Section VI. Conditions and
Requirements'' in this document, all drivers must submit quarterly and
annual evaluations from a board-eligible or board-certified
endocrinologist each year throughout the duration of the exemption, as
well as annual evaluations from an optometrist or ophthalmologist (if
the driver has diabetic retinopathy, the evaluation must be completed
by an ophthalmologist). In addition, exempted drivers are required to
receive an annual DOT physical examination to ensure that they meet all
other medical standards not related to ITDM.
    Daniel Adams submitted two comments addressing Ashley Warren's
comment, explaining the many evaluations drivers are required to submit
throughout the duration of their exemption period.

V. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

VI. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VII. Conclusion

    Based upon its evaluation of the 78 exemption applications, FMCSA

exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Daniel S. Adams (ME)
Michael L. Agnitsch (NE)
Shaun M. Aguayo (TX)
Earl W. Avery (TN)
Douglas W. Baker, Sr. (VA)
Michael A. Baker (CT)
Douglas E. Barron (SC)
Pablo H. Bilbao La Vieja Pozo (RI)
Todd D. Bloomfield (WA)
Sylvester G. Clements, Jr. (WI)
Fred W. Click (IN)
Kenneth M. Coco (TX)
Christopher R. Cook (NY)
Wygila M. Corliss (NM)
Timothy J. Cornish (OH)
Joshua D. Cresswell (NH)
Evan R. Dieken (MN)
Greg B. Duck (TX)
Arthur J. Dunn (PA)
Richard A. Durr (IL)
Daniel R. Eloff (OH)
Thomas O. Everett (WA)
Victor J. Flowers (CA)
Brian K. Forrest (PA)
David S. Fortune (VA)
Michael S. Frederick (NJ)
Peter E. Ganss (KS)
David E. Gates (MA)
Timothy L. Grant (NC)
James T. Heck (MN)
Rodney J. Hendricks (ID)
Marcus T. Herring (CA)
Charles R. Hoit (MO)
Jason L. Hubbard (MD)
Andy L. Hughes (IL)
Jammie L. Hughes (OH)
Charles J. Hurley (MN)
Rodney L. Johnson (OR)
Frederick B. Jones (TX)
Tito D. Jones (GA)
Scott M. Klain (OR)
Jeffrey P. Kloeckl (SD)
John J. Kress (AZ)
Russell A. Krogstad (MN)
John B. Lebherz (TX)
Alan S. Lewis (NM)
William M. Linskey (MA)
Jason D. Lowder (OH)
Arnold V. Magaoay (HI)
Norman C. Mallett (AR)
Patrick Marcantuono (NJ)
Daniel E. McDonald (MN)
William F. McQueen, Jr. (MO)
Kenneth M. Miller (ID)
William F. Mitchell (CT)
Donald L. Mitzel (PA)
Gino P. Monterio (WI)
Matthew K. Morrison (UT)
Gary R. Nelson (MN)
Edward L. Norfleet (AL)
Kyle R. Perry (PA)
Michael L. Plinski (WA)
Scott A. Porter (WA)
James A. Rambo (VA)
Rondo L. Rininger (IN)
Richard D. Sandison (ND)
Calvin R. Smith (IL)
Wesley J. Summerville (PA)
Jeffrey S. Thomas (PA)
Stephen M. Thompson (GA)
Randy L. Triplett (OH)
John E. Trygstad (SD)
Jared M. Wabeke (MI)
Steven R. Weir (MA)
Donald D. Willard (IA)
Gary W. Wozniak (NE)
Steven L. Yokom (ID)
Daniel R. Zuriff (MN)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: December 5, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-29152 Filed 12-11-14; 8:45 am]
BILLING CODE 4910-EX-P