[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Rules and Regulations]
[Pages 67315-67317]
[FR Doc No: 2021-25823]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0899; Airspace Docket No. 20-ANM-16]
RIN 2120-AA66

Modification of Class D Airspace; Gray AAF (Joint Base Lewis-
McChord), WA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies the Class D airspace at Gray AAF (Joint
Base Lewis-McChord), Fort Lewis/Tacoma, WA. After a review of the
airspace, the

FAA found it necessary to amend the existing airspace for the safety
and management of Instrument Flight Rules (IFR) operations at this
airport. This will also remove a reference to the McChord VORTAC from
the legal description, update the airport and city name and amend the
geographical coordinates for the airport to match the FAA's database.

DATES: Effective 0901 UTC, January 27, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov//air_traffic/publications/. For further information, you
can contact the Airspace Policy Group, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. FAA Order JO 7400.11F is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of FAA Order JO 7400.11F at NARA, email
[email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S. 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, part A, subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it will modify the Class D airspace to support IFR operations at
Gray AAF (Joint Base Lewis-McChord), Fort Lewis/Tacoma, WA.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 71290; November 9, 2020) for Docket No. FAA-2020-0899
to modify the Class D airspace at Gray AAF (Joint Base Lewis-McChord),
Fort Lewis/Tacoma, WA. Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal to the FAA. No comments were received.
    Class D airspace designations are published in paragraph 5000 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
D airspace designation listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending 14 CFR part 71 by modifying the lateral
dimensions of the Class D airspace. The Class D airspace lateral
boundary will be established within a 4-mile radius of the airport
instead of a 4.3-mile radius. The additional airspace is no longer
needed.
    In addition, the name and city of the airport and the geographical
coordinates for Gray AAF (Joint Base Lewis-McChord) will be updated to
match the FAA's National Airspace System Resource (NASR) database.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant the preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ANM WA D Fort Lewis/Tacoma, WA (Amend)

Gray AAF (Joint Base Lewis-McChord), WA
    (Lat. 47[deg]04'45'' N, long. 122[deg]34'51'' W)
McChord Field (Joint Base Lewis-McChord), WA
    (Lat. 47[deg]08'17'' N, long. 122[deg]28'35'' W)

    That airspace extending upward from the surface to and including
2,800 feet MSL within a 4-mile radius of Gray AAF, excluding the
portions within the McChord Field (Joint Base Lewis-McChord) Class D
airspace area. This Class D airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

    Issued in Des Moines, Washington, on November 18, 2021.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2021-25823 Filed 11-24-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Rules and Regulations]
[Pages 45351-45356]
[FR Doc No: 2018-19364]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2017-0399; FRL-9983-33--Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Nonattainment New Source Review Requirements for the 2008 8-
Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the Commonwealth of Virginia's state implementation plan
(SIP). The revision is in response to EPA's February 3, 2017 Findings
of Failure to Submit for various requirements relating to the 2008 8-
hour ozone national ambient air quality standards (NAAQS). This SIP
revision is specific to nonattainment new source review (NNSR)
requirements. EPA is approving this revision in accordance with the
requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on October 9, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2017-0399. 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
http://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: David Talley,<PHONE_NUMBER>, or by
email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On April 4, 2018 (83 FR 14386), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Virginia. In the NPR, EPA
proposed approval of the SIP submitted in response to EPA's final 2008
8-hour ozone NAAQS Findings of Failure to Submit for NNSR requirements.
See 82 FR 9158 (February 3, 2017). Specifically, Virginia is certifying
that its existing NNSR program, covering the Washington, DC
nonattainment area (which includes Alexandria City, Arlington County,
Fairfax County, Fairfax City, Falls Church City, Loudoun County,
Manassas City, Manassas Park City, and Prince William County in
Virginia) (hereafter, Washington, DC Nonattainment Area) for the 2008
8-hour ozone NAAQS, is at least as stringent as the requirements at 40
CFR 51.165, as amended by the final rule entitled ``Implementation of
the 2008 National Ambient Air Quality Standards for Ozone: State
Implementation Plan Requirements'' (SIP Requirements Rule),

for ozone and its precursors.\1\ See 80 FR 12264 (March 6, 2015). The
formal SIP revision was submitted by the Virginia Department of
Environmental Quality (VADEQ) on behalf of the Commonwealth of Virginia
on May 11, 2017.
---------------------------------------------------------------------------

    \1\ The SIP Requirements Rule addresses a range of nonattainment
area SIP requirements for the 2008 8-hour ozone NAAQS, including
requirements pertaining to attainment demonstrations, reasonable
further progress (RFP), reasonably available control technology,
reasonably available control measures, major new source review,
emission inventories, and the timing of SIP submissions and of
compliance with emission control measures in the SIP. The rule also
revokes the 1997 ozone NAAQS and establishes anti-backsliding
requirements. On February 16, 2018, the United States Court of
Appeals for the District of Columbia Circuit (D.C. Circuit) issued
an opinion granting a number of challenges to the EPA's SIP
Requirements Rule. South Coast Air Quality Mgmt. Dist. v. EPA, 882
F.3d 1138 (D.C. Cir. 2018). Specifically, as relevant here, the
Court vacated the ``redesignation substitute'' provision in the
implementation rule, which allowed states a way to satisfy anti-
backsliding requirements for revoked standards. EPA and South Coast
Air Quality Management District filed petitions for rehearing and
those petitions are pending before the Court.
---------------------------------------------------------------------------

    On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of
0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under
EPA's regulations at 40 CFR 50.15, the 2008 8-hour ozone NAAQS is
attained when the three-year average of the annual fourth-highest daily
maximum 8-hour average ambient air quality ozone concentration is less
than or equal to 0.075 ppm.
    Upon promulgation of a new or revised NAAQS, the CAA requires EPA
to designate as nonattainment any area that is violating the NAAQS
based on the three most recent years of ambient air quality data
available at the conclusion of the designation process. The Washington,
DC Nonattainment Area was classified as a marginal nonattainment area
for the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20,
2012) using 2008-2010 ambient air quality data. See 77 FR 30088. On
March 6, 2015, EPA issued the final SIP Requirements Rule, which
establishes the requirements that state, tribal, and local air quality
management agencies must meet as they develop implementation plans for
areas where air quality exceeds the 2008 8-hour ozone NAAQS. See 80 FR
12264. Areas that were designated as marginal ozone nonattainment areas
were required to attain the 2008 8-hour ozone NAAQS no later than July
20, 2015, based on 2012-2014 monitoring data. The Washington, DC
Nonattainment Area did not attain the 2008 8-hour ozone NAAQS by July
20, 2015; however, this area did meet the CAA section 181(a)(5)
criteria, as interpreted in 40 CFR 51.1107, for a one-year attainment
date extension. See 81 FR 26697 (May 4, 2016). Therefore, on April 11,
2016, the EPA Administrator signed a final rule extending the
Washington, DC Nonattainment Area 2008 8-hour ozone NAAQS attainment
date from July 20, 2015 to July 20, 2016.\2\
---------------------------------------------------------------------------

    \2\ EPA finalized approval of a Determination of Attainment
(DOA) for the 2008 8-hour ozone NAAQS for the Washington, DC
Nonattainment Area on November 14, 2017. This final action was based
on complete, certified, and quality assured ambient air quality
monitoring data for the 2013-2015 monitoring period. See 82 FR 52651
(November 14, 2017). It should be noted that a DOA does not
alleviate the need for Virginia to certify that their existing SIP
approved NNSR program is as stringent as the requirements at 40 CFR
51.165, as NNSR applies in nonattainment areas until an area has
been redesignated to attainment.
---------------------------------------------------------------------------

    Based on initial nonattainment designations for the 2008 8-hour
ozone standard, as well as the March 6, 2015 final SIP Requirements
Rule, Virginia was required to develop a SIP revision addressing
certain CAA requirements for the Washington, DC Nonattainment Area, and
submit to EPA a NNSR Certification SIP or SIP revision no later than 36
months after the effective date of area designations for the 2008 8-
hour ozone NAAQS (i.e., July 20, 2015).\3\ See 80 FR 12264 (March 6,
2015). EPA is proposing to approve Virginia's May 11, 2017 NNSR
Certification SIP revision. EPA's analysis of how this SIP revision
addresses the NNSR requirements for the 2008 8-hour ozone NAAQS is
provided in Section II.
---------------------------------------------------------------------------

    \3\ Neither Virginia's obligation to submit the NNSR
Certification SIP nor the requirements governing that submission
were affected by the D.C. Circuit's February 16, 2018 decision on
portions of the SIP Requirements Rule in South Coast Air Quality
Mgmt. Dist. v. EPA.
---------------------------------------------------------------------------

II. Summary of SIP Revision and EPA Analysis

    This rulemaking action is specific to Virginia's NNSR requirements.
NNSR is a preconstruction review permit program that applies to new
major stationary sources or major modifications at existing sources
located in a nonattainment area.\4\ The specific NNSR requirements for
the 2008 8-hour ozone NAAQS are located in 40 CFR 51.160-165. As set
forth in the SIP Requirements Rule, for each nonattainment area, a NNSR
plan or plan revision was due no later than 36 months after the
effective date of area designations for the 2008 8-hour ozone standard
(i.e., July 20, 2015).\5\
---------------------------------------------------------------------------

    \4\ See CAA sections 172(c)(5), 173 and 182.
    \5\ With respect to states with nonattainment areas subject to a
finding of failure to submit NNSR SIP revisions, such revisions
would no longer be required if the area were redesignated to
attainment. The CAA's prevention of significant deterioration (PSD)
program requirements apply in lieu of NNSR after an area is
redesignated to attainment. For areas outside the OTR, NNSR
requirements do not apply in areas designated as attainment.
---------------------------------------------------------------------------

    The minimum SIP requirements for NNSR permitting programs for the
2008 8-hour ozone NAAQS are located in 40 CFR 51.165. See 40 CFR
51.1114. These NNSR program requirements include those promulgated in
the ``Phase 2 Rule'' implementing the 1997 8-hour ozone NAAQS (75 FR
71018 (November 29, 2005)) and the SIP Requirements Rule implementing
the 2008 8-hour ozone NAAQS. Under the Phase 2 Rule, the SIP for each
ozone nonattainment area must contain NNSR provisions that: Set major
source thresholds for oxides of nitrogen (NOX) and volatile
organic compounds (VOC) pursuant to 40 CFR 51.165(a)(1)(iv)(A)(1)(i)-
(iv) and (2); classify physical changes as a major source if the change
would constitute a major source by itself pursuant to 40 CFR
51.165(a)(1)(iv)(A)(3); consider any significant net emissions increase
of NOX as a significant net emissions increase for ozone
pursuant to 40 CFR 51.165(a)(1)(v)(E); consider certain increases of
VOC emissions in extreme ozone nonattainment areas as a significant net
emissions increase and a major modification for ozone pursuant to 40
CFR 51.165(a)(1)(v)(F); set significant emissions rates for VOC and
NOX as ozone precursors pursuant to 40 CFR
51.165(a)(1)(x)(A)-(C) and (E); contain provisions for emissions
reductions credits pursuant to 40 CFR 51.165(a)(3)(ii)(C)(1)-(2);
provide that the requirements applicable to VOC also apply to
NOX pursuant to 40 CFR 51.165(a)(8); and set offset ratios
for VOC and NOX pursuant to 40 CFR 51.165(a)(9)(i)-(iii)
(renumbered as (a)(9)(ii)-(iv) under the SIP Requirements Rule for the
2008 8-hour ozone NAAQS). Under the SIP Requirements Rule for the 2008
8-hour ozone NAAQS, the SIP for each ozone nonattainment area
designated nonattainment for the 2008 8-hour ozone NAAQS and designated
nonattainment for the 1997 ozone NAAQS on April 6, 2015, must also
contain NNSR provisions that include the anti-backsliding requirements
at 40 CFR 51.1105. See 40 CFR 51.165(a)(12).
    Virginia's SIP-approved NNSR program is implemented through Article
9, Permits for Major Stationary Sources and Major Modifications
Locating in Nonattainment Areas or the Ozone Transport Region, in the
Virginia Administrative Code (VAC), 9VAC5-80--Permits for Stationary
Sources. In its May 11, 2017 SIP revision, Virginia certifies that the
version of 9VAC5-80

in the SIP is at least as stringent as the federal NNSR requirements
for the Washington, DC Nonattainment Area. EPA last approved revisions
to Virginia's major NNSR SIP on August 28, 2017. In that action, EPA
approved revisions to Virginia's SIP which made Virginia's NNSR program
consistent with federal requirements. Additionally, those revisions
corrected a deficiency which had been grounds for limited approval of
Virginia's program. EPA found, therefore, that Virginia's program met
all CAA requirements and was fully approvable. See 82 FR 40703.
    EPA notes that neither 9VAC5-80 nor Virginia's approved SIP have
the regulatory provision for any emissions change of VOC in extreme
nonattainment areas, specified in 40 CFR 51.165(a)(1)(v)(F), because
Virginia has never had an area designated extreme nonattainment for any
of the ozone NAAQS. Nonetheless, the Virginia SIP is not required to
have this requirement for VOC in extreme nonattainment areas until such
time as Virginia has an extreme ozone nonattainment area. In Virginia's
May 11, 2017 SIP revision, VADEQ asserted that anti-backsliding
provisions do not apply to any area within Virginia, including the
northern Virginia/Metropolitan Washington, DC area, because Virginia
submitted to EPA a final ``redesignation substitute'' request for the
1997 ozone NAAQS for the Washington, DC area on April 29, 2016. As
noted, in its February 16, 2018 decision, the South Coast Court vacated
the provision in the implementation rule for the 2008 ozone NAAQS that
created the ``redesignation substitute.'' The Court disagreed with
EPA's interpretation of the Clean Air Act that once a standard is
revoked, the Agency no longer has authority to change designations or
classifications for that revoked standard. The Court ruled that in
order for 1997 ozone nonattainment areas to be relieved from anti-
backsliding requirements under the old revoked standard, those areas
would need to seek, and EPA would need to approve, full statutory
redesignations to attainment in compliance with CAA section 107(d)(3).
The Court thus vacated the ``redesignation substitute,'' because it
held that areas could not receive the benefits of a redesignation
without meeting all of the elements in CAA section 107(d)(3)(E).
    Given the D.C. Circuit's vacatur of the redesignation substitute
mechanism in South Coast, EPA cannot approve Virginia's redesignation
substitute request. Therefore, until the Washington, DC Nonattainment
Area is redesignated under section 107(d)(3), the state remains
required to comply with the anti-backsliding provisions found in 40 CFR
51.165(a)(12) and located in 9VAC5-80 of its SIP which applied to NSR
requirements for the 1997 ozone NAAQS. EPA finds that the Virginia SIP
presently includes all required major stationary source thresholds and
emissions offset ratios for NSR purposes which were established for the
SIP for Virginia's 1997 8-hour ozone NAAQS nonattainment designation.
See 82 FR 40703 (finding Virginia's NNSR program consistent with all
federal requirements in August 2017).
    Thus, EPA finds that Virginia's SIP includes relevant and required
anti-backsliding requirements. Virginia has not changed these major
stationary source threshold and offset provisions in 9VAC5-80-2010 C,
and furthermore, they remain in Virginia's federally-approved SIP
unless and until EPA approves a full redesignation request in
accordance with CAA section 107.\6\ EPA expects that VADEQ will
continue to implement its NNSR program consistently with its approved
SIP for major stationary source thresholds and emission offset ratios.
---------------------------------------------------------------------------

    \6\ Under the 1997 8-hour ozone NAAQS, the Washington, DC Area
was classified as moderate nonattainment.
---------------------------------------------------------------------------

    EPA has not amended the SIP provisions related to 9VAC5-80 since
the August 28, 2017 rulemaking where EPA last approved Virginia's NNSR
provisions as meeting CAA requirements for a NNSR program. The SIP-
approved version of 9VAC5-80 covers Virginia's portion of the
Washington, DC Nonattainment Area and remains adequate to meet all
applicable NNSR requirements for the 2008 8-hour ozone NAAQS in 40 CFR
51.165, the Phase 2 Rule, and the SIP Requirements Rule.

III. Public Comments and EPA Response

    EPA received a total of sixteen sets of comments on the April 4,
2018 NPR. Fifteen of those did not concern any of the specific issues
raised in the NPR, nor did they address EPA's rationale for the
proposed approval of VADEQ's submittal. Therefore, EPA is not
responding to those comments. EPA did receive one set of relevant
comments. Those comments and EPA's responses are discussed in this
Section. All of the comments received are included in the docket for
this rulemaking action.
    Comment 1: The commenter asserts that EPA's proposed approval
failed to adequately address whether Virginia's SIP ensures that the
CAA's anti-backsliding requirements are met. In support of this claim,
the commenter first points to Virginia's May 11, 2017 submittal in
which VADEQ claims that anti-backsliding provisions don't apply because
Virginia submitted a redesignation substitute request on April 26,
2016, and asserts that redesignation substitutes were ruled unlawful by
the D.C. Circuit in the South Coast decision. Second, the commenter
takes issue with EPA's assertion in the NPR that Virginia's NNSR SIP
contains all of the requirements necessary to implement the 2008 8-hour
ozone NAAQS, citing EPA's failure to address a February 18, 2018
approval action related to the implementation of the 2008 ozone NAAQS
and the revocation of the 1997 ozone NAAQS.\7\ The commenter asserts
that until EPA addresses how ``the SIP as a whole,'' (including the
revisions from EPA's February 18, 2018 approval) meets the anti-
backsliding requirements, approval of Virginia's May 17, 2017 submittal
would be arbitrary and unlawful.
---------------------------------------------------------------------------

    \7\ See 83 FR 7610.
---------------------------------------------------------------------------

    EPA Response 1: The anti-backsliding requirements at both 40 CFR
51.165(a)(12) and 51.1105 provide that the minimum SIP elements for
NNSR outlined at 40 CFR 51.165 continue to apply in areas designated as
nonattainment for the 1997 ozone NAAQS that had not been redesignated
to attainment by EPA prior to the April 6, 2015 revocation date of the
1997 NAAQS. EPA agrees with the commenter that VADEQ's assertion that
the April 26, 2016 redesignation substitute request relieves Virginia
of the CAA's anti-backsliding requirements is not correct, first
because EPA never acted on that request and second because even if the
Agency had approved such request, the South Coast Court held that
redesignation substitutes cannot relieve nonattainment areas of anti-
backsliding requirements. EPA clearly and unambiguously stated in the
NPR (and restated in Section II of this document): ``Virginia remains
required to comply with the anti-backsliding provisions found in 40 CFR
51.165(a)(12) and located in 9VAC5-80 of its SIP which applied to NSR
requirements for the 1997 ozone NAAQS.'' \8\ EPA further stated that
Virginia is expected to implement its NNSR program consistent with its
approved SIP (which does contain the CAA's anti-backsliding
requirements) unless and until EPA promulgates a full redesignation of
the DC Area for the

2008 ozone NAAQS in accordance with CAA section 107(d)(3).
---------------------------------------------------------------------------

    \8\ See 83 FR 14388
---------------------------------------------------------------------------

    With respect to the commenter's assertion that EPA must evaluate
the SIP as a whole and in light of the February 18, 2018 approval
action, in order to grant approval to Virginia's May 17, 2017
submittal, EPA disagrees. EPA clearly stated in the NPR, and reiterates
in this action, this action is specific to the NNSR program
requirements of 40 CFR 51.165, which are codified by Virginia under
Article 9 of 9VAC5-80. EPA's February 18, 2018 approval action did not
revise or address any of the NNSR requirements in 9VAC5-80 and is
therefore irrelevant to this action. EPA is not obligated, when
reviewing each SIP submission, to re-review all prior SIP submissions
already acted on. Such an interpretation of the CAA would subject the
Agency to never-ending review of the state's implementation plan.
    The February 18, 2018 action approved revisions to 9VAC5-20-204,
9VAC5-30-55, 9VAC5-151-20, and 9VAC5-160-30. The amendment to 9VAC5-30-
55 added text stating that the primary and secondary ambient air
quality standard of 0.08 ppm shall no longer apply after April 6, 2015,
consistent with EPA's revocation of the 1997 standard. The revisions to
9VAC5-151-20 and 9VAC5-160-30 were related to transportation conformity
and general conformity, neither of which are germane to this action.
Subdivision (A)(2) of 9VAC5-20-204 defines and classifies the
nonattainment area for the 1997 ozone standard. EPA's February 18, 2018
final rulemaking action approved a revision to 9VAC5-20-204 which
provided that subdivision (A)(2) would no longer be effective after
April 6, 2015. This is appropriate given the revocation of the 1997
standard. It is important to note that subdivision (A)(2) was not
removed. Pursuant to 9VAC5-80-2000(B), the NNSR requirements of Article
9 apply to ``. . . nonattainment areas designated in 9VAC5-20-204 . .
.'' This is the mechanism through which Virginia's NNSR requirements
are applied to the various nonattainment areas in the Commonwealth.
While the nonattainment area status for the 1997 ozone NAAQS is no
longer active or ``effective'' due to the fact that that standard has
been revoked, the only ``designation'' and ``classification'' that
applies to the Washington DC Nonattainment Area for purposes of the
revoked 1997 ozone NAAQS, and specifically for purposes of establishing
the NNSR preconstruction permitting requirements of Article 9, remain
on the books at 9VAC5-20-204. Therefore, even if the February 18, 2018
action might require amendment in light of South Coast, such a revision
would not impact the effectiveness of EPA's final action approving
Virginia's NNSR SIP.
    Comment 2: The commenter asserts that EPA's proposed approval fails
to ensure compliance with certain other NNSR requirements in 40 CFR
51.165(a)(1)(v)(E), specifically the requirement that any significant
net emissions increase of nitrogen oxides (NOX) be
considered significant for ozone. The commenter points to part b. of
the definition of ``Major modification'' in 9VAC5-80-2010 which states:
``[a]ny significant emissions increase from any emissions units or net
emissions increase at a source that is considered significant for
volatile organic compounds shall be considered significant for ozone,''
and claims that the lack of similar language pertaining to
NOX creates ambiguity as to whether the requirements of 40
CFR 51.165(a)(1)(v)(E) are met.
    EPA Response 2: EPA disagrees that there is any ambiguity in
Virginia's NNSR SIP with regard to the potential for a significant net
increase of NOX to be considered significant for ozone. The
language identified by the commenter in part b. of the definition of
``Major modification'' in 9VAC5-80-2010 that is specific to volatile
organic compounds is simply a recitation of nearly identical language
in 40 CFR 51.165(a)(1)(v)(B) which is also specific to volatile organic
compounds and has no implications with regard to NOX.
Virginia's May 17, 2017 submittal identified the provisions of the SIP
which satisfy the requirement of 40 CFR 51.165(a)(1)(v)(E). First,
under the definition of ``regulated NSR pollutant'' at 9VAC5-80-2010C,
subdivisions a. and c.(1) include NOX and make clear that
NOX is regulated as a precursor to ozone.\9\ Additionally,
subdivisions a. and c. of the definition of ``Significant'' contain the
appropriate significance thresholds for NOX (40 tons per
year (tpy), or 25 tpy in areas designated as serious or severe
nonattainment). Finally, part a. of the definition of ``Major
modification'' in 9VAC5-80-2010 states that a major modification means
``any physical change in or change in the method of operation of a
major stationary source that would result in (i) a significant
emissions increase of a regulated NSR pollutant; and (ii) a significant
net emissions increase of that pollutant from the source.'' (emphasis
added) Because NOX is clearly included in the definition of
a ``Regulated NSR Pollutant,'' a significant emissions increase and a
significant net emissions increase of NOX would meet the
definition of ``Major Modification,'' thus satisfying the requirement
of 40 CFR 51.165(a)(1)(v)(E).
---------------------------------------------------------------------------

    \9\ 9VAC5-80-2010C in pertinent part reads as follows: `
``Regulated NSR Pollutant' means any of the following: a. Nitrogen
oxides or any volatile organic compound. . . . c. . . . . Precursors
identified for purposes of this article shall be the following: (1)
(1) Volatile organic compounds and nitrogen oxides are precursors to
ozone in all ozone nonattainment areas.''
---------------------------------------------------------------------------

IV. Final Action

    EPA is approving Virginia's May 17, 2017 SIP revision addressing
the NNSR requirements for the 2008 ozone NAAQS for the Washington DC
Nonattainment Area. EPA has concluded that the State's submission
fulfills the 40 CFR 51.1114 revision requirement, meets the
requirements of CAA sections 110 and 172 and the minimum SIP
requirements of 40 CFR 51.165, as well as its obligations under EPA's
February 3, 2017 Findings of Failure to Submit. See 82 FR 9158.

V. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) Are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.

    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
federally authorized environmental programs in a manner that is no less
stringent than their federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
NSR program consistent with the federal requirements. In any event,
because EPA has also determined that a state audit privilege and
immunity law can affect only state enforcement and cannot have any
impact on federal enforcement authorities, EPA may at any time invoke
its authority under the CAA, including, for example, sections 113, 167,
205, 211 or 213, to enforce the requirements or prohibitions of the
state plan, independently of any state enforcement effort. In addition,
citizen enforcement under section 304 of the CAA is likewise unaffected
by this, or any, state audit privilege or immunity law.

VI. 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 SIP approvals are exempted 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).
    The SIP is not approved to apply on any Indian reservation land as
defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

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 November 6, 2018. 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 Virginia's NNSR program and the 2008
ozone NAAQS 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, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: August 27, 2018.
Cecil Rodrigues,
Acting Regional Administrator, Region III.

    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 VV--Virginia

0
2. Amend Sec.  52.2420, paragraph (e)(1) table by adding an entry
entitled ``2008 8-Hour Ozone NAAQS Nonattainment New Source Review
Requirements'' at the end of the table to read as follows:

Sec.  52.2420   Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

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

                                                                      * * * * * * *
2008 8-Hour Ozone NAAQS Nonattainment  Virginia portion of the Washington, DC-      5/17/17  9/7/17, [Insert Federal  ..................................
 New Source Review Requirements.        MD-VA nonattainment area for the 2008                 Register citation].
                                        ozone NAAQS (i.e., Arlington County,
                                        Fairfax County, Loudoun County, Prince
                                        William County, Alexandria City,
                                        Fairfax City, Falls Church City,
                                        Manassas City, and Manassas Park City)
                                        as well as the portions of Virginia
                                        included in the Ozone Transport Region
                                        (OTR) (i.e., Arlington County, Fairfax
                                        County, Loudoun County, Prince William
                                        County, Stafford County, Alexandria
                                        City, Fairfax City, Falls Church City,
                                        Manassas City, and Manassas Park City).
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-19364 Filed 9-6-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Proposed Rules]
[Pages 55166-55168]
[FR Doc No: 2012-22064]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0945; Directorate Identifier 2010-SW-110-AD]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
(Sikorsky) Model Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
Sikorsky Model S-70, S-70A, S-70C, S-70C (M), and S-70C (M1)
helicopters with General Electric (GE) T700-GE-401C or T700-GE-701C
engines installed. This proposed AD is prompted by a reevaluation of
the method for determining the life limit for certain GE engine gas
generator turbine (GGT) rotor parts and the determination that these
life limits need to be based on low cycle fatigue events instead of
hours time-in-service. The proposed actions are intended to establish
new fatigue life limits for certain GGT rotor parts to prevent fatigue
failure of a GGT rotor part, engine failure, and subsequent loss of
control of the helicopter.

DATES: We must receive comments on this proposed AD by November 6,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    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 proposed AD, the
economic evaluation, any comments received, and other information. The
street address for the Docket Operations Office (telephone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this proposed AD, contact
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT, telephone
(800) 562-4409, email address<EMAIL_ADDRESS>or at http://www.sikorsky.com. You may review a copy of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Michael Davison, Flight Test Engineer,
New England Regional Office, FAA, 12 New England Executive Park,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is

possible to do so without incurring expense or delay. We may change
this proposal in light of the comments we receive.

Discussion

    We propose to adopt a new AD for the specified helicopters with GE
part-numbered T700-GE-401C or specified T700-GE-701C engines installed.
This proposed AD would require establishing a new life limit for
certain GGT rotor parts based upon the accumulated low cycle fatigue
events of the GGT rotor parts. This proposed AD is prompted by the
determination that the affected engines could fail due to fatigue
unless the life limits of certain GE engine rotor parts are changed
from hours time-in-service to low cycle fatigue events. The GE T700-GE-
701C engine is used in the military's UH-60 fleet. Analysis and
experience with this engine have caused the military to reduce the life
limit of certain GGT rotor parts and to revise their maintenance
documentation to reflect these revised life limits. The Sikorsky Model
S-70 helicopters are similar to the military's UH-60 fleet, some of
which have been certificated by the FAA in the restricted category. The
GE T700-GE-701C engine has not been type-certificated by the FAA for
civil use, except to the extent that it is a part of a restricted
category Model S-70 helicopter.

FAA's Determination

    We are proposing this AD because we evaluated all known relevant
information and determined that an unsafe condition exists and is
likely to exist or develop on other helicopters of these same type
designs.

Related Service Information

    GE has issued GE T700 Turboshaft Engine Service Bulletin (ESB) 72-
0038, dated October 1, 2008, for the T700-GE-701C engine (ESB 72-0038)
and GE T700 Turboshaft ESB 72-0041, dated August 21, 2009, for the
T700-GE-401C engine (ESB SB 72-041). These ESBs define a ``full-cycle
event'' and a ``partial cycle event,'' specify a method of calculating
the low cycle fatigue (LCF) life limit using formulas and LCF Limit
Diagrams, and specify counting LCF events to determine the remaining
fatigue life for specified GGT rotor parts. Finally, the ESBs specify
removing each life-limited rotor part from service when its newly-
established LCF life limit is reached.

Proposed AD Requirements

    This proposed AD would require, before further flight:
     Inserting the LCF limit diagrams into the airworthiness
limitation section of the maintenance manual or instructions for
continued airworthiness, shown in Figures 2 through 7 (pages 9 through
14) of ESB 72-0041 or Figures 2 through 4 (pages 10 through 12) of ESB
72-0038.
     Obtaining the actual LCF1 and LCF2 count from the engine
``history recorder'' (HR), and calculating the LCF1 and LCF2 fatigue
retirement life for each GGT rotor part.
     Replacing each GGT rotor part that has reached the new
fatigue cycle life limit with an airworthy rotor part.
     Calculating the life limit for the GGT rotor part with the
hours time-in-service for the part as shown in Table 1 of ESB 72-0041,
for those helicopters with the GE T700-GE-401C engine where the number
of low cycle fatigue events cannot be determined manually from the HR
or by combining both manual and HR counts.
     Before further flight, beginning or continuing to count
the full and partial low fatigue cycle events and recording on the
component card or equivalent record that count at the end of each day
for which the HR is inoperative.

Costs of Compliance

    We estimate that this proposed AD would affect 9 helicopters of
U.S. registry. We estimate that operators may incur the following costs
in order to comply with this AD:
     A minimal amount for work hours and labor costs because
these parts are replaced as part of the periodic maintenance on the
helicopter;
     A minimal amount of time to calculate the new retirement
life;
     $360,000 to replace the GGT rotor parts per helicopter;
and
     $3,240,000 to replace the GGT rotor parts for the entire
U.S. operator fleet.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. 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 an economic evaluation of the estimated costs to comply
with this proposed 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new
Airworthiness Directive (AD):

Sikorsky Aircraft Corporation: Docket No. FAA-2012-0945; Directorate
Identifier 2010-SW-110-AD.

(a) Applicability

    This AD applies to Model S-70, S-70A, S-70C, S-70C (M), and S-
70C (M1) helicopters with General Electric (GE) T700-GE-401C or
T700-GE-701C part-numbered engines, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a critical engine part
remaining in service beyond its fatigue life because the current
life limit is based on hours time-in-service (TIS) instead of
fatigue cycles. This condition could result in fatigue failure of an
engine rotor part, engine failure, and subsequent loss of control of
the helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(d) Required Actions

    (1) Before further flight, insert into the airworthiness
limitation section of the maintenance manual or instructions for
continued airworthiness the low cycle fatigue (LCF) limit diagrams
shown in Figures 2 through 7 (pages 9 through 14) of GE T700
Turboshaft Engine Service Bulletin (ESB) No. T700 S/B 72-0041, dated
August 21, 2009, for helicopters with the GE T700-GE-401C engine, or
Figures 2 through 4 (pages 10 through 12) of GE T700 Turboshaft ESB
No. T700 S/B 72-0038, dated October 1, 2008, for helicopters with
the GE T700-GE-701C engine. The diagonal line on each diagram
represents the new cycle life limit (a combination of full low cycle
fatigue events (LCF1) and partial low cycle fatigue events (LCF2) as
those terms are defined in the Accomplishment Instructions,
paragraphs 3.A.(1) and 3.A.(2) of each ESB) for each gas generator
turbine (GGT) rotor part. A combination of LCF1 and LCF2, which
results in a number below the diagonal line of the applicable
diagram for each engine, indicates that the part has not reached its
fatigue life limit.
    (2) Before further flight:
    (i) Obtain the actual LCF1 and LCF2 count from the engine
``history recorder'' (HR);
    (ii) Calculate the LCF1 and LCF2 fatigue retirement life for
each GGT rotor part as follows:
    (A) Determine the actual LCF ratio by dividing the total actual
LCF2 cycle count obtained from the HR by the total actual LCF1 cycle
count obtained from the HR. Add to the actual counts from the HR any
actual additional fatigue cycle incurred during any period in which
the HR was inoperative.
    (B) Determine the LCF1 retirement life by dividing the maximum
number of LCF2 events obtained from the applicable diagram for each
engine by the sum of the actual LCF ratio obtained by following
paragraph (d)(2)(ii)(A) of this AD plus the quotient of the maximum
number of LCF2 events from the applicable diagram for each engine
divided by the maximum number of LCF1 events from the applicable
diagram for each engine.
    (C) Determine the LCF2 retirement life by multiplying the actual
LCF ratio obtained by following paragraph (d)(2)(ii)(A) of this AD
times the LCF1 retirement life determined by following paragraph
(d)(2)(ii)(B) of this AD.
    (iii) Replace each GGT rotor part that has reached the new
fatigue cycle life limit with an airworthy rotor part.
    (3) For helicopters with the GE T700-GE-401C engine, if you
cannot determine the number of low cycle fatigue events manually
from the HR or by combining both manual and HR counts, then the life
limit for the GGT rotor part is the hours TIS for the part as shown
in Table 1 of ESB No. T700 S/B 72-0041, dated August 21, 2009.
    (4) Before further flight, begin or continue to count the full
and partial low fatigue cycle events and record on the component
card or equivalent record that count at the end of each day for
which the HR is inoperative.

(e) Special Flight Permit

    Special flight permits will not be issued to allow flight in
excess of life limits.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Send your proposal to: Michael Davison,
Flight Test Engineer, New England Regional Office, FAA, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    For service information identified in this AD, contact Sikorsky
Aircraft Corporation, Attn: Manager, Commercial Technical Support,
mailstop s581a, 6900 Main Street, Stratford, CT, telephone (800)
562-4409, email address<EMAIL_ADDRESS>or at http://www.sikorsky.com. You may review a copy of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 7250: Turbine
Section.

    Issued in Fort Worth, Texas, on August 30, 2012.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-22064 Filed 9-6-12; 8:45 am]
BILLING CODE 4910-13-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [PV Shah,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

[Rhodia Inc.]

[2E8010]

	EPA has received a pesticide petition ([2E8010]) from [Rhodia Inc., c/o SciReg, Inc.], [12733 Director's Loop, Woodbridge, VA 22192] 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 180.910 to establish an exemption from the requirement of a tolerance for 	[methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate (CAS No. 1174627-68-9) and related reaction products, herein referred to as methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, under 40 CFR 180.910 when used as an inert ingredient in pesticide formulations.] 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.

	2. Analytical method. [Rhodia is requesting that methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate be exempt from the requirement of a tolerance under 40 CFR 180.910. Therefore, Rhodia believes that an analytical method to determine residues in treated crops is not relevant.]

	3. Magnitude of residues. [Rhodia is requesting that methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate be exempt from the requirement of a tolerance under 40 CFR 180.910. Therefore, Rhodia believes that data on the magnitude of residues in treated crops is not relevant.]

B. Toxicological Profile

	1. Acute toxicity.  [Acute Oral Toxicity

The acute oral toxicity of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was assessed in the rat in accordance with OECD Guideline No. 423 (2001) and U.S. EPA Guideline OPPTS 870.1100. The study was performed in compliance with the Principles of Good Laboratory Practice Regulations [Hungarian GLP Regulations: 9/2001.(III.30.) EüM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development] which corresponds to the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

Two groups each of three female (W1) BR Wistar rats were treated with methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate by oral gavage administration at a dose of 2,000 mg/kg body weight. The test item was administered undiluted at a dose volume of 1.92 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs and mortality within the first 30 minutes and at approximately 1, 2, 3, 4 and 6 hours after treatment on Day 1 and once daily during test Days 2-15. Body weights were recorded on Day -1, Day 0 (prior to administration) and on Days 7 and 14. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for rats of this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose LD50 (female rat) of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate after single oral administration was found to be greater than 2,000 mg/kg body weight.

Acute Dermal Toxicity

The acute dermal toxicity of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was assessed in the rat in accordance with OECD Guideline No. 402 (1987). The study was performed in compliance with UK GLP standards [Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994] which are in accordance with the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

A group of ten Wistar (RccHan:WIST) rats (five males and five females) were given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose of 2,000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to a gross necropsy.

There were no deaths. Red/brown staining around the snout was noted in two males during the day of dosing. There were no other signs of systemic toxicity noted. There were no signs of dermal irritation. Animals showed expected gains in body weight over the study period except for one female which showed bodyweight loss during the first week but expected gain in body weight during the second week. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2,000 mg/kg body weight.

Primary Eye Irritation

The acute ocular irritation potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was assessed in the rabbit in accordance with OECD Guideline No. 405 (2002) and U.S. EPA Guideline OPPTS 870.2400. The study was performed in compliance with the Principles of Good Laboratory Practice Regulations [Hungarian GLP Regulations 9/2001.(III.30.) EüM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development] which corresponds to the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

The test item was placed into the conjunctival sac of the left eye of each of three New Zealand White rabbits. The untreated right eye served as control. A volume of 0.1 mL of the test item was administered as a single dose. The eyes were examined at 1, 24, 48, amd 72 hours and 1 and 2 weeks after application of the test item.

Instillation of the test solution produced evidence of irritant effects in the eyes of all three rabbits. An Initial Pain Reaction (IPR) (score 2) was observed in all animals.  One hour after the application, conjunctival redness (score 2) was observed in all animals, conjunctival chemosis (score 3) was noted in all animals, conjunctival  discharge (score 3) was seen in all animals and corneal opacity (score 1, area 4) was observed in two animals. Effects were still observed at 24, 48, and 72 hours in all the  animals with individual mean scores at 24, 48, and 72 hours after treatment as  follows: 0.67, 0.33, 0.00 for iritis; 3.00, 2.67, 1.67 for conjunctival redness; 0.33, 1.33,  0.67 for conjunctival chemosis; and 1.00, 1.00, 1.00 for corneal opacity.

At one week after treatment, conjunctival redness (score 1) was still present in two animals and corneal opacity (score 1, area 2) was observed in one rabbit. At two weeks after treatment, no clinical signs were observed, irritation was considered to be fully reversible within this period and the study was terminated. During the study, the control eye of each animal was symptom-free. The general state and behavior of animals were normal throughout the study period. There were no notable body weight changes during the study period. Based on the reported scores, the maximum mean total score (MMTS) can be calculated as 34/110 at 24-hours. The test substance is considered a moderate ocular irritant (modified Kay and Calandra interpretation of eye irritation).

Primary Dermal Irritation

The acute skin irritation potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was assessed in the rabbit in accordance with OECD Guideline No. 404 (2002) and U.S. EPA Guideline OPPTS 870.2500. The study was performed in compliance with the Principles of Good Laboratory Practice Regulations [Hungarian GLP Regulations 9/2001.(III.30.) EüM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development] which corresponds to the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

The test item was administered undiluted at a single dose of 0.5 mL to three New Zealand White rabbits. Gauze was placed onto the clipped skin of each rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control. After four hours, the remaining test item was removed with water at body temperature. To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after patch removal. Additional general examinations were performed daily.

There was no mortality and no systemic clinical changes were observed throughout the study. There was no effect of treatment on body weight. No clinical signs were noted on the skin of the treated animals at the 1, 24, 48 and 72 hours observations after patch removal (readings were 0 for both erythema and edema formation). As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation. Based on these results, the test substance methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not considered a skin irritant.

Dermal Sensitization

The contact allergenic potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was assessed in the mouse in a local lymph node assay in accordance with OECD Guideline No. 429 (2002). The study was performed in compliance with the Principles of Good Laboratory Practice Regulations [Hungarian GLP Regulations 9/2001.(III.30.) EüM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development] which corresponds to the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

Based on the results of the preliminary compatibility test, the test item was dissolved in an acetone:olive oil 4:1 mixture (AOO). The maximum attainable concentration was 50%. The Preliminary Irritation/Toxicity Test was performed in CBA/J@Rj mice using two doses [test item concentrations of 50 and 25 (w/v) %] in the selected vehicle. The applicability and biocompatibility of the test item on the ears of animals at the maximum concentration of test item of 50% was acceptable. In the main assay, 20 female CBA/J@Rj mice were allocated to five groups of four animals each. Three groups received the appropriate formulation of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate at concentrations of 50%, 25% and 10%, the negative control group received AOO and the positive control group received 25 (w/v) % α-Hexylcinnamaldehyde (HCA) in AOO. The test item solutions were applied on the dorsal surface of ears of experimental animals (25 μl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. No local signs of irritation of the ear skin were detected. Stimulation Indices (S.I.) of 1.7, 1.6 and 1.2 were determined with the test item at concentrations of 10, 25 and 50% in AOO, respectively. The validity of the assay was demonstrated from the positive control substance HCA25% in AOO, with S.I. of 9.4.

Based on the results of this study, the test substance methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not considered a skin sensitizer.]

	2. Genotoxicty. [Bacterial Reverse Mutation Test

The potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate to induce gene mutations in bacteria was assessed in accordance with OECD Guideline No. 471 (1997) and U.S. EPA Guideline OPPTS 870.5100. The study was performed in compliance with the Principles of Good Laboratory Practice Regulations [Hungarian GLP Regulations 9/2001.(III.30.) EüM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development] which corresponds to the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

The assay was performed using Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537, and Escherichia coli strain WP2 uvrA in two independent experiments in the plate incorporation test (experiment I) and the pre-incubation test (experiment II), both with and without liver microsomal activation at concentrations from 5 to 5,000 ug/plate. Each concentration, including the controls, was tested in triplicate.

The plates incubated with the test item showed normal background growth up to 5,000 ug/plate with and without metabolic activation in both independent experiments. No toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), occurred in the test groups with or without metabolic activation. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate at any dose level, either in the presence or absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

Under the experimental conditions of this study, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.  Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is therefore considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.

In Vitro Mammalian Cell Gene Mutation Test

The potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster in vitro was assessed in accordance with OECD Guideline No. 476 (1998). The study was performed in compliance with the OECD Principles of Good Laboratory Practice as revised in 1997 [C(97)186/Final].

The assay was performed in two independent experiments. The cells were exposed to the test item for four hours in the first experiment with and without metabolic activation. The second experiment was performed with a treatment time of four hours with and 24 hours without metabolic activation. The highest concentration of the test item was equal to a molar concentration of about 10 mM. The tested concentrations were from 17.3 to 2,220 ug/mL.

No substantial and reproducible dose dependent increase of the mutation frequency was observed in either main experiment. Appropriate reference mutagens, used as  positive controls, induced a distinct increase in mutant colonies and, thus showed  the sensitivity of the test system and the activity of the metabolic activation system.

Under the experimental conditions reported, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate did not induce gene mutations at the HPRT locus in V79 cells.

In Vitro Mammalian Chromosome Aberration Test

The potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate to induce structural chromosomal aberrations in human lymphocytes in vitro was assessed in accordance with OECD Guideline No. 473 (1997). The study was performed in compliance with the OECD Principles of Good Laboratory Practice as revised in 1997 [C(97)186/Final].

The test item, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, dissolved in deionized water, was examined in two independent experiments. In each experimental group, two parallel cultures were analyzed. Per culture, 100 metaphases were scored for structural chromosomal aberrations. The highest applied concentration in this study (2,220 ug/mL of the test item, approximately 10 mM) was chosen with regard to the molecular weight and the purity of the test item and with respect to the current OECD Guideline. Dose selection of the cytogenetic experiment was performed considering the toxicity data. The treatment concentrations were from 14.4 to 2,220 ug/mL.

In the absence and presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In both independent experiments, neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures. Appropriate mutagens were used as positive controls. These induced statistically significant increases (p < 0.05) in cells with structural chromosome aberrations.

Under the experimental conditions reported, the test item did not induce structural chromosomal aberrations in human lymphocytes in vitro. Therefore, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is considered to be non-clastogenic in this chromosome aberration test, when tested up to the highest required concentration.

In vivo Mammalian Erythrocyte Micronucleus Test

The potential of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate to produce damage to chromosomes or aneuploidy was investigated according to OECD Guideline 474 (1997). The study was performed in compliance with UK GLP standards [Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994] which are in accordance with the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

The micronucleus test was conducted using the intraperitoneal route in groups of seven mice (males) at the maximum tolerated dose (MTD) of 2,000 mg/kg and with 1,000 and 500 mg/kg as the two lower dose levels. Animals were killed 24 or 48 hours later, the bone marrow extracted, and smear preparations made and stained. Polychromatic (PCE) and normochromatic (NCE) erythrocytes were scored for the presence of micronuclei. Additional groups of mice were given a single intraperitoneal dose of distilled water (seven male mice) or dosed orally with cyclophosphamide (five male mice), to serve as vehicle and positive controls, respectively. Vehicle and positive control animals were killed after 24 hours.

There were no premature deaths seen in any of the dose groups in the main test. Clinical signs consisting of hunched posture, ptosis and ataxia were observed in animals dosed with the test item at and above 1,000 mg/kg in both the 24 and 48-hour dose groups Animals dosed at 2,000 mg/kg in both the 24 and 48-hour dose groups exhibited decreased respiratory rate, labored respiration and loss of righting reflex up to 10 minutes after dosing. The observation of the clinical signs was taken to indicate that systemic absorption had occurred and exposure to the target tissue had been achieved. No statistically significant decreases in the PCE/NCE ratio were observed in any of the test item dose groups when compared to the vehicle control group. There were no statistically significant increases in the frequency of micronucleated PCE in any test item dose groups. The positive control group showed a marked increase in the incidence of micronucleated polychromatic erythrocytes hence confirming the sensitivity of the system to the known mutagenic activity of cyclophosphamide under the conditions of the test.

Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was considered to be non-genotoxic under the conditions of the test.]

	3. Reproductive and developmental toxicity. [Combined Repeat Dose Toxicity with Reproduction/Developmental Toxicity Screening Test

The systemic toxicity and potential adverse effects of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate on reproduction including offspring development was investigated in accordance with OECD  Guideline 422 (1996). The study was performed in compliance with UK GLP standards [Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994] which are in accordance with the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

The test item was administered by oral gavage to three groups, each of ten male and ten female Wistar Han(TM):RccHan(TM):WIST strain rats, for up to eight weeks (including a two week maturation phase, pairing, gestation and early lactation for females), at dose levels of 30, 300 and 1,000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone (distilled water). Clinical signs, behavioral assessments, body weight change, food and water consumption were monitored during the study. Pairing of animals within each dose group was undertaken on a one male:one female basis within each treatment group on Day 15 of the study, with females subsequently being allowed to litter and rear their offspring to Day 5 of lactation. During the lactation phase, daily clinical observations were performed on all surviving offspring, together with litter size and offspring weights and assessment of surface righting reflex. Extensive functional observations were performed on five selected males from each dose group after the completion of the mating phase, and for five selected parental females from each dose group on Day 4 post partum. Hematology and blood chemistry were evaluated prior to termination on five selected males and females from each dose group. Adult males were terminated on Day 43, followed by the termination of all females and offspring on Day 5 post partum. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed.

There were no deaths during the study. Clinical findings were confined to transient episodes of increased salivation in one 300 mg/kg bw/day male on Day 17 and among animals of either sex at 1,000 mg/kg bw/day between Days 30 and 46. There were no treatment-related changes in the behavioral parameters measured, functional performance or sensory reactivity. Weight development in all test animals was comparable to that of the controls throughout the treatment period. No adverse effects on food consumption, food efficiency or water consumption were detected in test animals in comparison with controls.

There was no evidence of treatment-related changes in the hematological parameters measured and no convincing treatment-related adverse effects identified for the biochemistry profile. There were no macroscopic abnormalities detected. An increase (p < 0.01) in absolute and relative liver weight was identified in 1,000 mg/kg bw/day males. Females at this dose level showed an increase (p < 0.05) in absolute and relative kidney weight in comparison with controls. Individual values all fell within the historical ranges for rats of the age and strain used. Treatment related microscopic findings were confined to minimal to slight centrilobular hepatocyte hypertrophy in four out of five males receiving 1,000 mg/kg bw/day. None of these changes were considered to be toxicologically significant, therefore the NOAEL for systemic toxicity was considered to be 1,000 mg/kg bw/day. No treatment-related systemic toxicity was detected in either sex at 30 and 300 mg/kg bw/day, therefore the NOEL for systemic toxicity was considered to be 300 mg/kg bw/day.

There were no treatment-related effects on mating, conception rate or gestational length in animals of either sex treated with 30, 300 or 1,000 mg/kg bw/day. Of the litters born, litter size at birth and subsequently on Day 1 and Day 4 post partum, as well as, offspring body weight gain and litter weights were comparable to controls. No adverse effects were detected in surface righting reflex on Day 1. No effect on the reproductive organs of parental animals was detected during post mortem or histopathological assessments. There was no evidence of any developmental effects observed in offspring from treated litters. The NOEL for reproductive toxicity was therefore considered to be 1,000 mg/kg bw/day.]

	4. Subchronic toxicity. [Combined Repeat Dose Toxicity with Reproduction/Developmental Toxicity Screening Test

The systemic toxicity and potential adverse effects of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate on reproduction including offspring development was investigated in accordance with OECD Guideline 422 (1996). The study was performed in compliance with UK GLP standards [Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994] which are in accordance with the OECD Principles of Good Laboratory Practice [ENV/MC/CHEM(98)17].

The test item was administered by oral gavage to three groups, each of ten male and ten female Wistar Han(TM):RccHan(TM):WIST strain rats, for up to eight weeks (including a two week maturation phase, pairing, gestation and early lactation for females), at dose levels of 30, 300 and 1,000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone (distilled water). Clinical signs, behavioral assessments, body weight change, food and water consumption were monitored during the study. Pairing of animals within each dose group was undertaken on a one male:one female basis within each treatment group on Day 15 of the study, with females subsequently being allowed to litter and rear their offspring to Day 5 of lactation. During the lactation phase, daily clinical observations were performed on all surviving offspring, together with litter size and offspring weights and assessment of surface righting reflex. Extensive functional observations were performed on five selected males from each dose group after the completion of the mating phase, and for five selected parental females from each dose group on Day 4 post partum. Hematology and blood chemistry were evaluated prior to termination on five selected males and females from each dose group. Adult males were terminated on Day 43, followed by the termination of all females and offspring on Day 5 post partum. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed.

There were no deaths during the study. Clinical findings were confined to transient episodes of increased salivation in one 300 mg/kg bw/day male on Day 17 and among animals of either sex at 1,000 mg/kg bw/day between Days 30 and 46. There were no treatment-related changes in the behavioral parameters measured, functional performance or sensory reactivity. Weight development in all test animals was comparable to that of the controls throughout the treatment period. No adverse effects on food consumption, food efficiency or water consumption were detected in test animals in comparison with controls.

There was no evidence of treatment-related changes in the hematological parameters measured and no convincing treatment-related adverse effects identified for the biochemistry profile. There were no macroscopic abnormalities detected. An increase (p < 0.01) in absolute and relative liver weight was identified in 1,000 mg/kg bw/day males. Females at this dose level showed an increase (p < 0.05) in absolute and relative kidney weight in comparison with controls. Individual values all fell within the historical ranges for rats of the age and strain used. Treatment related microscopic findings were confined to minimal to slight centrilobular hepatocyte hypertrophy in four out of five males receiving 1,000 mg/kg bw/day. None of these changes were considered to be toxicologically significant, therefore the NOAEL for systemic toxicity was considered to be 1,000 mg/kg bw/day. No treatment-related systemic toxicity was detected in either sex at 30 and 300 mg/kg bw/day, therefore the NOEL for systemic toxicity was considered to be 300 mg/kg bw/day.

There were no treatment-related effects on mating, conception rate or gestational length in animals of either sex treated with 30, 300 or 1,000 mg/kg bw/day. Of the litters born, litter size at birth and subsequently on Day 1 and Day 4 post partum, as well as, offspring body weight gain and litter weights were comparable to controls. No adverse effects were detected in surface righting reflex on Day 1. No effect on the reproductive organs of parental animals was detected during post mortem or histopathological assessments. There was no evidence of any developmental effects observed in offspring from treated litters. The NOEL for reproductive toxicity was therefore considered to be 1,000 mg/kg bw/day.]

	5. Chronic toxicity. [No experimental carcinogenicity study is available on methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate. Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was assessed using the knowledge-based expert system DEREK for Windows (software version DfW 9.0.0,14_08_2006). The expert system DEREK has been designed for the qualitative prediction of the possible toxicity of chemicals and the following endpoints were searched for this structure: carcinogenicity, genotoxicity, HERG channel inhibition, irritation, respiratory sensitization, skin sensitization, thyroid toxicity, and miscellaneous endpoints. The toxicity assessments are based on the presence of specific substructures. The ester amide structure of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate triggered the alert "irritation of the gastrointestinal tract", with a level of likelihood "Plausible" [Structural alert 048: alpha-substituted propionic acid or ester; rules 47 and 243]. This prediction is associated with the methyl group being close to an ester link such that substituted propionic acid could be created, triggering an alert for gastrointestinal irritation based on the side effects documented in the knowledge database with propionic acid-based nonsteroidal anti-inflammatory drugs (NSAIDs) following administration by the oral and parenteral routes. Their irritancy is reported to be predominantly a consequence of physico-chemical disruption of the gastric intestinal mucosa. As an automatic consequence of triggering the structural alert for gastrointestinal irritation, the super-endpoint of carcinogenicity was also triggered with the same likelihood (Rule 704).

In DEREK, the endpoint carcinogenicity can be triggered due to extrapolation from certain other endpoint alerts as opposed to specific, recognized, carcinogenic  toxicophores. It is well-recognized in the scientific literature that gastrointestinal irritation is not necessarily relevant to predict cancer risk in humans. No other alerts were triggered. The other minor structures present as impurities in the substance (including the impurities methyl 4-(dimethylamino)-ethyl-4-oxobutanoate, and N1,N1,N5,N5,2-pentamethylpentanediamide) did not trigger any alert in the DEREK model.

In the absence of significant findings in the gastrointestinal tract during macroscopic and histopathology examination in rats treated by oral gavage for up to eight weeks, and considering the absence of genotoxic effects in the available in vitro and in vivo studies, the alert in the DEREK model is not considered predictive of a particular toxicological concern or carcinogenicity potential that would be relevant to the use conditions foreseen.]

	6. Animal metabolism. [NA-Remove.]

	7. Metabolite toxicology. [NA-Remove.]

	8. Endocrine disruption. [There is no available evidence demonstrating that methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is an endocrine disruptor in humans.]

C. Aggregate Exposure

	1. Dietary exposure. [In examining aggregate exposure, section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

It is anticipated that methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate will be used as a solvent in EC formulations at a concentration no higher than 30%. Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not expected to be persistent in the environment based on a PBT assessment of the substance. Further, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate has a low toxicity profile as demonstrated through acute, subchronic, developmental, and mutagenicity testing. Therefore, dietary exposure to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate should not be of concern.

Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate will not be applied directly to water. Agricultural practices minimize spray drift and typical end-use product labels prohibit direct application to water. Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is inherently biodegradable and is not expected to be persistent in the environment. Therefore, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate as a solvent in EC formulations does not pose a risk to drinking water.

Overall, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is considered to be a low toxicity substance with a reasonable certainty of no harm from dietary exposure and all other nonoccupational sources of exposure.]

	i. Food. [NA-Remove.]

	ii. Drinking water. [NA-Remove.]

	2. Non-dietary exposure. [NA-Remove.]

D. Cumulative Effects

	[Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of the particular pesticide's residues and "other substances that have a common mechanism of toxicity."

Rhodia has not found methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate to share a common mechanism of toxicity with any other substances, and methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate does not appear to produce a toxic metabolite produced by other substances.

Resultant risks, separately and/or combined with other substances that may have a common mechanism of toxicity, should be low for methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate. Rhodia does not expect any adverse cumulative effects associated with the use of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate.]

E. Safety Determination

	1. U.S. population. [Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate exhibits a low toxicity profile, as demonstrated by the acute, subchronic, carcinogenicity, reproductive, and developmental studies summarized above. Further, methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was not mutagenic in in vitro and in vivo studies. When methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is used on raw agricultural commodities in accordance with good agricultural practice, it is expected to meet the reasonable certainty of no harm requirement. Based on the low toxicity profile of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, there is no reason to believe that adverse effects on the U.S. population will result from the use of this inert ingredient in pesticide formulations. In addition, there is no reason to believe that infants and children will be disproportionately at risk to the use of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate in pesticide formulations.]

	2. Infants and children. [NA-Remove.]

F. International Tolerances

	[There are no known U.S. or international tolerances or tolerance exemptions for methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate.]