[Federal Register: April 7, 2010 (Volume 75, Number 66)]
[Notices]
[Page 17712-17713]
[DOCID:fr07ap10-50]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0979; FRL-8820-1]

Malathion and Diquat Dibromide; Cancellation Order for Amendments
to Terminate Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the amendments to
terminate uses, voluntarily requested by the registrants and accepted
by the Agency, of uses of the products listed in Table 1, pursuant to
section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended. This cancellation order follows a February 10,
2010 Federal Register Notice of Receipt of Requests from the
registrants listed in Table 2 to voluntarily amend to terminate certain
uses of these product registrations. These are not the last products
containing these pesticides registered for use in the United States. In
the February 10, 2010 Notice, EPA indicated that it would issue an
order implementing the amendments to terminate uses, unless the Agency
received substantive comments within the 30-day comment period that
would merit its further review of these requests, or unless the
registrants withdrew their requests within this period. The Agency
received one comment on the notice, but this comment did not merit the
Agency's further review of the requests. Further, the registrants did
not withdraw their requests. Accordingly, EPA hereby issues in this
notice a cancellation order granting the requested amendments to
terminate uses. Any distribution, sale, or use of the products subject
to this cancellation order is permitted only in accordance with the
terms of this order, including any existing stocks provisions.

DATES: The cancellations are effective April 7, 2010.

FOR FURTHER INFORMATION CONTACT: Eric Miederhoff, Pesticide Re-
evaluation Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0979. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What Action is the Agency Taking?

    This notice announces the amendments to terminate uses, as
requested by registrants, for products registered under section 3 of
FIFRA. These registrations are listed in sequence by registration
number in Table 1 of this unit.

                                    Table 1.-- Amended Product Registrations
----------------------------------------------------------------------------------------------------------------
         EPA Registration No.                Product Name          Active Ingredient        Delete from Label
----------------------------------------------------------------------------------------------------------------
100-1061                               Reglone Desiccant        Diquat dibromide         Sorghum (seed crop
                                        Herbicide                                         only) Soybean (seed
                                                                                crop only)
----------------------------------------------------------------------------------------------------------------
4787-46                                Atrapa[reg] 8E           Malathion                Animal premise and
                                                                                barns used for dairy
                                                                                and livestock
----------------------------------------------------------------------------------------------------------------
67760-40                               Fyfanon[reg] 57% EC      Malathion                Animal premise and
                                                                                barns used for dairy
                                                                                and livestock
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number.

                Table 2.--Registrants of Amended Products
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
100                                         Syngenta Crop Protection,
                                             Inc.
                                            P.O. Box 18300
                                            Greensboro, NC 27419-8300
------------------------------------------------------------------------
4787                                        Cheminova, A/S
                                            P.O. Box 110566
                                            One Park Drive, Suite 150
                                            Research Triangle Park, NC
                                             27709
------------------------------------------------------------------------
67760                                       Cheminova, Inc.
                                            Washington Office
                                            1600 Wilson Boulevard Suite
                                             700
                                            Arlington, VA 22209
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received one comment
in response to the February 10, 2010 Federal Register notice announcing
the Agency's receipt of the requests for voluntary amendments to
terminate uses of products listed in Table 1 of Unit II.
    The commenter, Stephen A. McFadden, stated that organophosphate
insecticides (OP) as a class are too neurotoxic to be used safely in
high human exposure applications, such as indoor uses, urban aerial
spray programs, and uses that result in high residual levels in foods.
McFadden suggested that high levels of exposure to cholinesterase
inhibitors such as OP insecticides - may cause a state of permanent
hypersensitivity to cholinesterase inhibitors. Nonetheless, the
commenter supported the Agency's implementation of the voluntary use
termination requests for malathion, an organophosphate insecticide.
    The amendments to terminate uses that McFadden commented on were
not risk-based actions resulting from an Agency risk assessment, but
were voluntarily requested by the registrant. However, McFadden's
comment suggests that organophosphate insecticides such as malathion
are too toxic for uses other than those included in this cancellation
action. Malathion is currently undergoing Registration Review. During
this process, the Agency intends to review and revise its existing risk
assessments for malathion. The Agency will consider McFadden's comment
as the human health risk assessment for malathion is revised.
     For these reasons, the Agency does not believe that the comment
submitted during the comment period merit further review or a denial of
the requests for voluntary use termination.

 IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
amendments to terminate uses of malathion and diquat dibromide
registrations identified in Table 1 of Unit II. Accordingly, the Agency
orders that the product registrations identified in Table 1 of Unit II.
are hereby amended to terminate the affected uses. Any distribution,
sale, or use of existing stocks of the products identified in Table 1
of Unit II. in a manner inconsistent with any of the Provisions for
Disposition of Existing Stocks set forth in Unit VI. will be considered
a violation of FIFRA.

V. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The effective date of the amendments to terminate
uses is April 7, 2010. The cancellation order that is the subject of
this notice includes the following existing stock provisions:
    The registrant may sell and distribute existing stocks of products
listed in Table 1 of Unit II. under the previously approved labeling
which includes the deleted uses until April 7, 2011. Persons other than
the registrant may sell and distribute existing stocks of products
listed in Table 1 of Unit II. whose labels include the deleted uses
until exhausted. Use of the products whose labels include the deleted
uses listed in Table 1 of Unit II. may continue until existing stocks
are exhausted, provided that such use is consistent with the terms of
the previously approved labeling on, or that accompanied, the products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 26, 2010.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-7505 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Page 17583]
[FR Doc No: 2020-06513]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]

Allergenic Products Advisory Committee; Cancellation of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The meeting of the Allergenic Products Advisory Committee
scheduled for May 15, 2020, is canceled. The Allergenic Products
Advisory Committee meeting scheduled for May 15, 2020, to discuss and
make recommendations on the safety and efficacy of Peanut (Arachis
hypogaea) Allergen Extract manufactured by DBV Technologies, S.A, has
been canceled to allow time for the FDA to review outstanding issues.
The Agency intends to continue evaluating the product and will schedule
an Advisory Committee meeting in the future, as needed. The meeting was
announced in the Federal Register on February 24, 2020.

FOR FURTHER INFORMATION CONTACT: Kathleen Hayes, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6307, Silver Spring, MD 20993-0002, 301-
796-7864<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting, which was announced in the Federal Register of February 24,
2020, 85 FR 10451.

    Dated: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06513 Filed 3-27-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48730-48733]
[FR Doc No: 2015-20023]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2015-0454; FRL-9932-35-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Movement of the Northern Virginia Area From Virginia's
Nonattainment Area List to its Maintenance Area List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the Virginia State Implementation
Plan (SIP). The revisions move the localities (Counties of Arlington,
Fairfax, Loudon, and Prince William; Cities of Alexandria, Fairfax,
Falls Church, Manassas, and Manassas Park) of Northern Virginia from
Virginia's list of nonattainment areas to its list of maintenance areas
for fine particulate matter (PM2.5). EPA is approving these
revisions in accordance with the requirements of the Clean Air Act
(CAA).

DATES: This rule is effective on October 13, 2015 without further
notice, unless EPA receives adverse written comment by September 14,
2015. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2015-0454 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2015-0454, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Air Protection Division, Mail
code 3AP30, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2015-0454. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI, or otherwise protected, through www.regulations.gov or email.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Maria A. Pino,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Particle pollution, or particulate matter, is a mixture of solid
particles and liquid droplets found in the air. Particle pollution
includes ``inhalable coarse particles,'' with diameters larger than 2.5
micrometers and smaller than 10 micrometers and ``fine particles,''
with diameters that are 2.5 micrometers and smaller. Due to their small
size, these particles often contribute to adverse health effects. EPA
is required to set National Ambient Air Quality Standards (NAAQS) under
the authority of the CAA, for the purpose of controlling particle
pollution. The first NAAQS for PM2.5 were established on
July 16, 1997 (62 FR 38652). EPA promulgated an annual standard at a
level of 15 micrograms per cubic meter ([mu]g/m\3\), based on a three-
year average of annual mean PM2.5 concentrations (the 1997
annual PM2.5 standard). In the same rulemaking action, EPA
promulgated a 24-hour standard of 65 [mu]g/m\3\, based on a three-year
average of the 98th percentile of 24-hour concentrations.
    EPA published air quality area designations for the 1997
PM2.5 standards on January 5, 2005. In its rulemaking
action, EPA designated the Washington, DC-MD-VA Area as nonattainment
for the 1997 annual PM2.5 standard. The Washington, DC-MD-VA
area (Washington Area) is composed of the District of Columbia;
Arlington, Fairfax, Loudoun, and Prince William Counties and the cities
of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park in
Virginia (the Northern Virginia area); and Charles, Frederick,
Montgomery,

and Prince George's Counties in Maryland.
    The District of Columbia Department of the Environment (DDOE), the
Maryland Department of the Environment (MDE), and the Virginia
Department of Environmental Quality (VADEQ), (collectively, the
States), collaborated to develop redesignation requests and maintenance
plans for the Washington Area for the 1997 annual PM2.5
NAAQS. EPA received the 1997 annual PM2.5 redesignation
requests and maintenance plans for the Washington Area from DDOE on
June 3, 2013, from MDE on July 10, 2013, and from VADEQ on June 3,
2013. The Washington Area maintenance plan included motor vehicle
emissions budgets (MVEBs) for PM2.5 and nitrogen oxides
(NOX) for the Washington Area for the 1997 annual
PM2.5 standard, which EPA approved for transportation
conformity purposes. The emissions inventories included in the
Washington Area maintenance plans were subsequently supplemented by the
States to provide for emissions estimates of volatile organic compounds
(VOC) and ammonia. The supplemental inventories were submitted to EPA
on July 22, 2013 by DDOE, on July 26, 2013 by MDE, and on July 17, 2013
by VADEQ.
    On October 6, 2014 (79 FR 60081), the EPA approved the States'
redesignation requests and maintenance plans for the Washington Area,
including Northern Virginia, for the 1997 annual PM2.5
standard. Therefore, the designation of the Northern Virginia area, as
part of the Washington Area, was changed from nonattainment to
attainment. Subsequently, Virginia changed its lists of areas in
nonattainment and maintenance within its regulations, located in 9 VAC5
Chapter 20, to reflect EPA's redesignation of the Washington Area.

II. Summary of SIP Revision

    On June 1, 2015, the Commonwealth of Virginia submitted a formal
revision to its SIP. The SIP revision consists of a regulatory change
that moves the Northern Virginia area (Counties of Arlington, Fairfax,
Loudoun, and Prince William; Cities of Alexandria, Fairfax, Falls
Church, Manassas, and Manassas Park), which was part of the Washington
Area, from the list of nonattainment areas found in regulation 9 VAC 5-
20-204 to the list of maintenance areas found in regulation 9 VAC 5-20-
203.

III. 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
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.

IV. Final Action

    EPA is approving the proposed regulatory amendment which moves the
localities in Northern Virginia (Counties of Arlington, Fairfax,
Loudoun, and Prince William; Cities of Alexandria, Fairfax, Falls
Church, Manassas, and Manassas Park) from the list of nonattainment
areas found in regulation 9 VAC 5-20-204 to the list of maintenance
areas found in regulation 9 VAC 5-20-203. EPA finds this revision to
the SIP is in accordance with CAA requirements, including sections 107
and 110 of the CAA.
    EPA is publishing this rule without prior proposal because EPA
views this as a noncontroversial amendment and anticipates no adverse
comment. However, in the ``Proposed Rules'' section of today's Federal
Register, EPA is publishing a separate document that will serve as the
proposal to approve the SIP revision if adverse comments are filed.
This rule will be effective on October 13, 2015 without further notice
unless EPA receives adverse comment by September 14, 2015. If EPA
receives adverse comment, EPA will publish a timely withdrawal in the
Federal Register informing the public that the rule will not take
effect. EPA will address all public comments in a subsequent final rule
based on the proposed rule. EPA will not institute a

second comment period on this action. Any parties interested in
commenting must do so at this time. Please note that if EPA receives
adverse comment on an amendment, paragraph, or section of this rule and
if that provision may be severed from the remainder of the rule, EPA
may adopt as final those provisions of the rule that are not the
subject of an adverse comment.

V. Incorporation by Reference

    In this rulemaking action, the EPA is finalizing regulatory text
that includes incorporation by reference. In accordance with
requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by
reference of changes to 9 VAC5 Chapter 20, specifically 9VAC5-20-203
and 9VAC5-20-204, described in the amendments to 40 CFR part 52 set
forth below. The EPA has made, and will continue to make, these
documents generally available electronically through
www.regulations.gov and/or in hard copy at the appropriate EPA office
(See the ADDRESSES section of this preamble for more information).

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 Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP revision applies to Northern Virginia and does not
apply in Indian country, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 13, 2015. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action. This action, which moves the localities in Northern
Virginia within the Washington Area (Counties of Arlington, Fairfax,
Loudoun, and Prince William; Cities of Alexandria, Fairfax, Falls
Church, Manassas, and Manassas Park) from the list of nonattainment
areas found in regulation 9 VAC 5-20-204 to the list of maintenance
areas found in regulation 9 VAC 5-20-203, 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, Intergovernmental relations, Particulate matter.

    Dated: August 4, 2015.
William C. Early,
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. In Sec.  52.2420, the table in paragraph (c) is amended by revising
the entries for Sections 5-20-203 and 5-20-204. The revised text reads
as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (c) * * *

                                 EPA-Approved Virginia Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
                                                          State
         State citation              Title/Subject      effective    EPA Approval date   Explanation [former SIP
                                                           date                                 citation]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
9 VAC 5, Chapter 20.............                                General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Part II.........................                               Air Quality Programs
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
5-20-203........................  Air Quality              3/11/15  8/14/15 [Insert      List of maintenance
                                   Maintenance.                      Federal Register     areas revised to
                                  Areas..............                Citation].           include Northern
                                                                                Virginia localities
                                                                                for fine particulate
                                                                                matter (PM2.5).
5-20-204........................  Nonattainment Areas      3/11/15  8/14/15 [Insert      List of nonattainment
                                                                     Federal Register     areas revised to
                                                                     Citation].           exclude Northern
                                                                                Virginia localities
                                                                                for fine particulate
                                                                                matter (PM2.5).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-20023 Filed 8-13-15; 8:45 am]
BILLING CODE 6560-50-P


Residues of saflufenacil and its metabolites M800H11 and M800H35 in apple samples were quantified by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on apple fruit.

The results from this study demonstrated that individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, combined residues were <0.03 ppm in/on apple samples (unwashed fruit) harvested at 0-day PHI following a total application of 0.67 lb ai/A (5X).  Since quantifiable residues were not found in the whole fruit, analysis of juice and wet pomace was not carried out. Therefore, a conclusion regarding the comparison of saflufenacil residues in processed apple commodities with theoretical concentration factors cannot be reached.

Conclusions:  The submitted apple processing data are adequate to fulfill data requirements.  As the residues in the RAC were <LOQ after treatment at a 5X rate, separate tolerances for wet apple pomace and apple juice will not be required.

Citrus

DER Reference List	47128228.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in oranges and processed orange commodities (juice, dried pulp, and oil).  BAS 800 00 H (saflufenacil, 70% ai, WG) was applied to oranges as three broadcast orchard floor applications of 0.22 lb ai/A each for a total seasonal application rate of 0.67 lb ai/A (5X).  Applications were made at a RTI of 20-21 days starting at 42 days before harvest, with 30 gal/A using ground equipment.  An adjuvant was included in the spray mixture.

 samples were stored frozen (≤-20(C) at the field facility for 25 days before being shipped directly to the laboratory (these samples were not analyzed, since raw oranges were subsampled prior to processing for analysis from the bulk sample shipped to the processor).  Bulk orange samples used for processing were delivered to the processing facility on the day of harvest.  Both sets of samples were placed in cool storage at 3-8ºC prior to collection of RAC fractions or processing into dried pulp, juice, and oil.  Processing was completed within 15 days of harvest and was carried out using protocols simulating commercial processing procedures.

Residues of saflufenacil and its metabolites M800H11 and M800H35 in orange samples were quantified by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on orange fruit and orange oil.

Results from this study demonstrated that individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, combined residues were <0.03 ppm in/on orange samples (unwashed fruit; n=2) harvested at 0-day PHI following a total application of 0.67 lb ai/A (5X).  Since quantifiable residues were not found in the whole fruit, analysis of dried pulp and juice was not carried out.  Residues of each analyte were also below LOQ (<0.01 ppm) in citrus oil samples (n=2) derived from the orange fruit samples.  As the residues of saflufenacil were below LOQ in citrus oil, and dried pulp and juice were not analyzed; concentration factors could not be determined.

Conclusions:  The submitted citrus processing data are adequate to fulfill data requirements.  As the residues in the RAC and oil were <LOQ after treatment at a 5X rate, separate tolerances for citrus oil, dried pulp, and juice will not be required.

Grape

DER Reference List	47128232.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in grapes and processed grape commodities (juice and raisins).  BAS 800 00 H (saflufenacil, 70% ai, WG) was applied to grapes as three broadcast vineyard floor applications of 0.044-0.046 lb ai/A for a total seasonal application rate of 0.134 lb ai/A (2X).  The applications were made at dormancy (146 days prior to harvest), 21 days prior to harvest and on the day of harvest with 34-36 gal/A using ground equipment.  An adjuvant was included in the spray mixture.

Mature grapes were harvested on the last day of application (0-day PHI) from one untreated control plot and one treated plot.  One set of the treated and control bulk grape samples was shipped by overnight courier on blue ice to be delivered to the processing facility on the same day and was placed in cool storage at approximately 4ºC prior to processing into juice.  Processing into juice was completed within 9 days of harvest and was carried out using protocols simulating commercial processing procedures.  Following frozen storage for 17 days, these samples were shipped to the same processing facility for collection of fractions.  Processing into raisins was completed within 105 days of harvest.  A second set of treated and control bulk grape samples harvested on the same day as the first set was field-dried for 20 days and collected as sun-dried raisins.

Residues of saflufenacil and its metabolites M800H11 and M800H35 in grape samples were quantitated by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on grapes.

The results from this study demonstrated that individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, combined residues were <0.03 ppm in/on grape samples (unwashed fruit) harvested at 0-day PHI following a total application of 0.134 lb ai/A (2X).  Since quantifiable residues were not found in the whole fruit, analysis of grape juice and raisins was not carried out. Therefore, a conclusion regarding the comparison of saflufenacil residues in processed grape commodities with theoretical concentration factors cannot be reached.

Conclusions:  The submitted grape processing data are adequate to fulfill data requirements.  As the residues in the RAC and oil were <LOQ after treatment at a 2X rate, separate tolerances for grape juice and raisins will not be required.  Note that HED previously approved the use of rates <5X due to phytotoxicity concerns (Memorandum of Understanding, BASF with EPA and PMRA, 1/25/06; MRID No. 47128215).

Plum

DER Reference List	47128230.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in plums and processed plum commodities (prunes).  Three broadcast applications of BAS 800 00 H (saflufenacil, 70% ai, WG) were made to the ground in a plum orchard.  The first application was made at a rate of 0.154 lb ai/A followed by two applications at a rate of 0.226-0.229 lb ai/A each for a total seasonal application rate of 0.61 lb ai/A (4.7X).  The applications were made at dormancy (140 days prior to harvest), 20 days prior to harvest and on the day of harvest with 30-31 gal/A using ground equipment.  An adjuvant was included in the spray mixture.

Mature plums were harvested on the day of the last application (0-day PHI) from one untreated control plot and one treated plot.  Bulk samples of plums were delivered to the processing facility the next day under ambient conditions and were placed in cool storage at 4ºC prior to processing into prunes.  Processing was completed within seven days of harvest and was carried out using protocols simulating commercial processing procedures.

Residues of saflufenacil and its metabolites M800H11 and M800H35 in plum samples were quantitated by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on plum fruit.

The results from this study demonstrated that individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, combined residues were <0.03 ppm in/on plum samples (unwashed fruit) harvested at 0-day PHI following a total application of 0.61 lb ai/A (4.7X).  Since quantifiable residues were not found in the whole fruit, analysis of prunes was not carried out.  Therefore, a conclusion regarding the comparison of saflufenacil residues in processed plum commodities with theoretical concentration factors cannot be reached.

Conclusions:  The submitted plum processing data are adequate to fulfill data requirements.  As the residues in the RAC were <LOQ after treatment at a 4.7X rate, a separate tolerance for dried prunes will not be required.

Cereal Grain

DER Reference List	47128231.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in cereal grain (field corn, winter wheat, sweet sorghum, and rice) processed fractions.  BAS 800 00 H (saflufenacil, 70% ai, WG) was applied to cereal grains as a single broadcast pre-emergence soil surface application using ground equipment.  An adjuvant was included in the spray mixture.

For winter wheat, saflufenacil was applied on the day of planting at a rate of 0.22 lb ai/A (1.6X) in 36.8 gal/A of water.  Wheat grain samples for processing were harvested at maturity (280 days after planting).

For field corn, saflufenacil was applied on the day of planting at a rate of 0.27 lb ai/A (2X) in 15.0 gal/A of water.  Corn grain samples for processing were harvested at maturity (154 days after planting).

For rice, saflufenacil was applied one day after planting at a rate of 0.21 lb ai/A (1.6X) in 13.6 gal/A of water.  Rice grain samples for processing were harvested at maturity (151 days after planting).

For sweet sorghum, saflufenacil was applied on the day of planting at a rate of 0.089 lb ai/A (0.7X) in 15.8 gal/A of water.  A lower rate was used, since the 0.267 lb ai/A (2X) rate applied to a first planting caused 100% plant mortality.  Sweet sorghum stalk samples for processing were harvested at maturity (104 days after planting).

Mature cereals were harvested from one untreated control plot and one treated plot.  Bulk samples of wheat and rice grains were shipped to the processing facility on the same day by freezer truck; bulk samples of corn grains and sorghum stalks were frozen at the field facility and shipped to the processing facility 4-5 days after harvest by freezer truck.  All samples were kept in frozen storage throughout the study and were only thawed for processing and for extraction.  Processing was carried out using protocols simulating commercial processing procedures.

Wheat was processed into aspirated grain fractions (AGF), middlings, flour, shorts, bran, and wheat germ.  Corn was processed into AGF, grits, meal, and flour (all dry milled), oil (both wet and dry milled), and starch (wet milled).  Rice was processed into hulls, bran and polished rice, while sorghum stalks were processed into sorghum syrup.  Both treated and control samples were processed.

Residues of saflufenacil and its metabolites M800H11 and M800H35 in cereal samples were quantified by analytical method D0603, an LC-MS/MS method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on the grain of field corn, winter wheat, and rice.  The LOQ was determined as 0.025 ppm each for saflufenacil, M800H11, and M800H35 in/on sweet sorghum stalk.

The results from this study demonstrated that individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, combined residues were <0.03 ppm in/on wheat, corn, and rice grain samples harvested at maturity following a single pre-emergence application of 0.21-0.27 lb ai/A (1.6-2X). The individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.025 ppm, and correspondingly, total residues were <0.075 ppm in/on sweet sorghum stalk samples harvested at maturity following a single pre-emergence application of 0.089 lb ai/A (0.7X).  Since quantifiable residues were not found in samples of wheat, corn and rice grain, and sorghum stalk, analysis of processed commodities was not carried out.  Therefore, a conclusion regarding the comparison of saflufenacil residues in processed cereal grain commodities with theoretical concentration factors cannot be reached.

Conclusions:  The submitted cereal grain processing data are adequate to fulfill data requirements.  As the residues in the RACs were <LOQ (0.025 ppm for each analyte in sweet sorghum stalk and 0.01 ppm for each analyte in grain) after treatment at a 0.7X-2X rate, separate tolerances for residues in processed cereal grain commodities will not be required.  Note that HED previously approved the use of rates <5X due to phytotoxicity concerns (Memorandum of Understanding, BASF with EPA and PMRA, 1/25/06; MRID No. 47128215).

Cotton

DER Reference List	47445902.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in cotton and processed cotton commodities (refined oil, meal, and hulls).  BAS 800 00 H (saflufenacil, 70% ai, WG) was applied to cotton as a single pre-emergence broadcast application to the soil surface at a rate of 0.045 lb ai/A (1X) or 0.112 lb ai/A (2.5X).  The application was made one day after planting in 28.3 gal/A of water using ground equipment.  An adjuvant was included in the spray mixture.

The bulk seed cotton samples used to generate the processed fractions in the present study were harvested at commercial harvest timing, 176 days after planting (175 DAT), using a mechanical spindle picker.  The unginned cotton samples for processing were shipped 3-5 days following harvest by overnight courier under ambient conditions to the processing facility, where they were placed in frozen storage.  Processing was carried out using protocols simulating commercial processing procedures.  Processed samples were shipped frozen to the analytical laboratory, where they were kept frozen, extracted within 105-109 days, and analyzed on the same day (hulls and meal) or within 4 days (oil).

Residues of saflufenacil and its metabolites M800H11 and M800H35 in cotton undelinted seed, hull, meal, and refined oil samples were quantitated by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on cotton undelinted seeds, cotton hull, meal, and refined oil.

In these trials, the cotton plot treated at a rate of 2.5X showed severe crop injury; therefore, the processing studies were conducted with seed from plots treated at a lower rate (1x).  The results from this study demonstrated that, following a single broadcast soil surface application of saflufenacil on cotton at a total rate of 0.045 lb ai/A (1X), the individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, combined residues were <0.03 ppm in cotton hull, meal, and refined oil from cottonseed harvested at 175 DAT (176 days after planting).  As the combined residues of saflufenacil were below LOQ in cotton seed, hulls, meal, and refined oil, concentration factors could not be determined.

Conclusions:  The submitted cotton processing data are adequate to fulfill data requirements.  As the residues in the RAC were <LOQ after treatment at a 1X rate, separate tolerances for residues in cotton hulls, meal, and refined oil will not be required.  Note that HED previously approved the use of rates <5X due to phytotoxicity concerns (Memorandum of Understanding, BASF with EPA and PMRA, 1/25/06; MRID No. 47128215).

Soybean

DER Reference List	47128227.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in soybeans and processed soybean commodities (refined oil, meal, hulls, and AGF).  BAS 800 00 H (saflufenacil, 70% ai, WG) was applied to soybean plants one day after planting as a single broadcast pre-emergence application at a rate of 0.089 lb ai/A (1X) or 0.267 lb ai/A (3X).  The applications were made in 22.5 gal/A of water using ground equipment.  An adjuvant was included in the spray mixture.

Mature soybean samples were harvested 126 days after planting (125 days after the pre-emergent application of saflufenacil) from one untreated control plot and two treated plots.  Bulk seed samples of soybeans were held at ambient temperatures for a day and delivered to the processing facility by freezer truck within 18 days, where they were placed in frozen storage at ≤-12ºC prior to processing.  Processing into seed, AGF, hulls, meal, and oil was completed within 81-109 days of harvest and was carried out using protocols simulating commercial processing procedures.

Residues of saflufenacil and its metabolites M800H11 and M800H35 in soybean samples were quantified by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11 and M800H35 in/on soybean seed.

The results from this study demonstrated that the individual residues of saflufenacil and its metabolites M800H11 and M800H35 were below their LOQs of 0.01 ppm each, and correspondingly, the combined residues were <0.03 ppm in/on soybean seed samples harvested at a 125-day PHI following a total application of 0.267 lb ai/A (3X).  Since quantifiable residues were not found in soybean seeds, analysis of processed commodities was not carried out.  Therefore, a conclusion regarding the comparison of saflufenacil residues in processed soybean commodities with theoretical concentration factors cannot be reached.

Conclusions:  The submitted soybean processing data are adequate to fulfill data requirements.  As the residues in the RAC were <LOQ after treatment at a 3X rate, separate tolerances for soybean AGF, hulls, meal, and oil will not be required.  Note that HED previously approved the use of rates <5X due to phytotoxicity concerns (Memorandum of Understanding, BASF with EPA and PMRA, 1/25/06; MRID No. 47128215).

Sunflower

DER Reference List	47128233.der.doc

A processing study was carried out to determine the magnitude of saflufenacil residues in sunflowers and processed sunflower commodities (refined oil and meal).  BAS 800 00 H (saflufenacil, 70% ai, WG) was applied to sunflowers as two late-season broadcast applications of 0.229 lb ai/A and a RTI of 6 days, for a total seasonal application rate of 0.458 lb ai/A (5X). The applications were initiated 13 days prior to mature dry seed harvest and were made in 20.5-20.6 gal/A of water using ground equipment.  An adjuvant was included in the spray mixture.

Mature sunflowers were harvested from one untreated control plot and one treated plot at a PHI of 7 days.  Bulk samples of the RAC of sunflower seeds were frozen at the field facility following harvest and shipped to the processing facility by freezer truck.  Processing was carried out using protocols simulating commercial processing procedures.

Residues of saflufenacil and its metabolites M800H11 and M800H35 in sunflower seed, meal, and oil samples were quantified by analytical method D0603, an LC-MS/MS method.  Concurrent recoveries were determined for each analyte during sample analysis to demonstrate the validity of the method.  The LOQ was determined as 0.01 ppm each for saflufenacil, M800H11, and M800H35 in/on sunflower seeds and the processed sunflower commodities, meal, and refined oil.

The results from this study demonstrated that, following a foliar broadcast application of BAS 800 H on sunflowers at a total rate of 0.458 lb ai/A (5X) with a PHI of 7 days, the mean combined residues of saflufenacil and its metabolites M800H11 and M800H35 were 0.31 ppm in/on sunflower seed, 0.24 ppm in meal, and below the combined LOQ (<0.03 ppm) in refined oil.  A comparison of the combined saflufenacil residues in sunflower seed with those in processed fractions resulted in concentration factors of 0.8X for meal and <0.1X for refined oil.  It can be concluded that residues of saflufenacil do not concentrate in sunflower meal and oil.

Table 34.  Residue Data from Sunflower Processing Study with Saflufenacil.

Processed Commodity	Total Rate	PHI

(days)	Residues (ppm)	Combined Residues (ppm)	Concentration factor

	Saflufenacil	M800H11	M800H35

Sunflower

Seed RAC	513 g ai/ha (0.458 lb ai/A)	7	0.28*, 0.30*	<0.01*, <0.01* <0.01*, <0.01*	0.30, 0.32	NA

Meal

	0.21, 0.22	<0.01, <0.01	<0.01, <0.01	0.23, 0.24	0.8x

Refined Oil

	<0.01, <0.01	<0.01, <0.01	<0.01, <0.01	<0.03, <0.03	0.1x

* Mean results for multiple analyses of two replicate samples (For saflufenacil, replicate A: 0.26, 0.32, 0.28, 0.27 ppm; replicate B: 0.27, 0.33, 0.32, 0.26 ppm).

Conclusions:  The submitted sunflower processing data are adequate to fulfill data requirements. As no concentration (<1X) of the total saflufenacil residue was found in any processed commodity, separate tolerances for residues in sunflower meal and oil will not be required.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference Standards

Analytical standards of saflufenacil, M800H11, and M800H35 are currently available in the National Pesticide Standards Repository [source:  personal communication with T. Cole of ACL/BEAD, 1/15/09].  However, since the standards for M800H11 and M800H35 expired on 10/1/08, the petitioner is requested to provide a new supply to the Repository.  The reference standards should be sent to the ACL, which is located at Fort Meade, to the attention of Theresa Cole at the following address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850 Confined Accumulation in Rotational Crops

DER Reference List	47128017.der.doc

The metabolism of saflufenacil in rotational crops was investigated using lettuce, radish and wheat after a single spray application of the test substance in the EC formulation BAS 800 UBH at a nominal application rate of 0.134 lbs. ai/A (1X).  The active substance was applied to bare loamy sand soil in plastic containers placed under natural climatic conditions without the influence of rain in a glass roofed vegetation hall or in a glass house.  Treatment was performed with either [phenyl-U-14C]-saflufenacil or [uracil-4-14C]-saflufenacil.  The nature and the level of radioactive residues were investigated in lettuce (head), white radish (roots and tops), and spring wheat (forage, straw, chaff, and grain) after PBIs of 30, 58 (lettuce and radish only), 120, and 365 days.  Plant samples were harvested at maturity.  Additional wheat forage samples were taken 48 to 68 days after sowing.

The TRR were determined by the sum of the extractable and non-extractable residues.  Frozen samples were homogenized and successively extracted with methanol (three times) and water (twice).  The extractable radioactive residues were measured by LSC, and the residual radioactive residues (non-extractable residues) after solvent extraction were determined by combustion analysis.  In most plant samples taken after a PBI of 30 days and for samples of wheat grain at 365 DAT (uracil label), the metabolites extracted with methanol were characterized by liquid/liquid partition.  The nature of the residues in methanol extracts was investigated using two methods of HPLC with radiodetection.  Metabolite identification was based on LC-MS and LC-MS/MS analyses of purified fractions isolated from the methanol extracts of spring wheat chaff (30 DAT, phenyl label and 120 DAT, uracil label) and on co-chromatography with reference items (e.g., extract from corn cell biotransformation suspension cultures).  Storage stability of radioactive residues for both the phenyl and the uracil label has been demonstrated for representative homogenized samples of lettuce head (high water content) for a storage period up to 20 months and for representative samples of spring wheat straw (low water content matrix) for a storage period up to approximately 17 months.  Storage stability of the methanol extracts has been demonstrated over 9 months for spring wheat straw (phenyl label), and over 10 months for lettuce head (uracil label) and spring wheat straw (uracil label), through re-analysis by HPLC of the stored extracts.

The major metabolites identified (≥10% of the TRR and/or ≥0.1 ppm) with the phenyl label were the parent compound, saflufenacil (34.2% of TRR; 0.003 ppm), and the metabolite M800H01 (13.7% of TRR; 0.001 ppm) for lettuce head at 30 DAT, the parent compound (8.4-13.8 % of TRR; 0.001-0.004 ppm) and the metabolites M800H01 (10.5-16.0% of TRR; 0.001-0.004 ppm), M800H11 (9.0-13.1% of TRR; 0.001-0.003 ppm), and M800H10 (and/or an unknown medium polar compound, counted as characterized) (15.9-20.0% of TRR; 0.003-0.004 ppm) for white radish top at 30 and 120 DAT, and the metabolites M800H05 (0.2-17.6% of TRR; <0.0005-0.053 ppm), M800H35/M800H09 (3.2-42.3% of TRR; 0.001-0.162 ppm (confirmatory analysis using a different HPLC system indicated that the peak was mostly M800H35)), and M800H10 (and/or an unknown medium polar compound, counted as characterized) (0.3-20.7% of TRR; <0.0005-0.044 ppm) for spring wheat.

The only major metabolite identified with the uracil label for all rotational crop matrices was the metabolite TFA.  The residue level of TFA was calculated in parent-equivalents and based on the [molecular mass of TFA].  The residue of TFA ranged from 89.8-95.9% of TRR (0.076-0.085 ppm [0.017-0.019 ppm]) in lettuce head; from 88.4-89.3% of TRR (0.010-0.030 ppm [0.002-0.007 ppm]) in white radish root; from 84.8-92.2% of TRR (0.039-0.149 ppm [0.009-0.034 ppm]) in white radish top; from 79.4-90.9% of TRR (0.014-0.160 ppm [0.003-0.037 ppm]) in spring wheat forage; from 73.7-77.4% of TRR (0.149-0.262 ppm [0.034-0.060 ppm]) in spring wheat straw; from 81.6-88.0% of TRR (0.358-1.413 ppm [0.082-0.322 ppm]) in spring wheat chaff; and from 37.3-87.8% of TRR (0.043-0.325 ppm [0.010-0.075 ppm]) in spring wheat grain. Except for lettuce head (both labels), the calculated TRR in rotational crops decreased between the 30 days and 120 days plant back interval; however, in about half the plant matrices, the TRR increased slightly between the 120 and 365 days PBIs (both labels).

Saflufenacil in rotational crops was metabolized by:  a) stepwise degradation (N-dealkylation) of the N-methyl-N-isopropyl group to NH2, forming a sulphonamide group; b) a N-demethylation at the uracil ring; and c) a hydrolytic cleavage of the uracil ring generating a urea side chain.  The metabolite M800H35 was identified as a metabolite in which the methyl group of the N-methyl-N-isopropyl unit was lost and the uracil ring was cleaved generating a urea side chain.  Metabolites M800H01 and M800H05 resulted from stepwise demethylation and dealkylation of the N-methyl-N-isopropyl group to NH2.  Metabolite M800H11 was formed by demethylation of the methyl group of the N-methyl-N-isopropyl unit and demethylation of the N-methyl group in the uracil ring.  M800H10 was identified as a derivative of saflufenacil in which the N-isopropyl group was lost and the uracil ring was demethylated.  The metabolite TFA was only found in the uracil label.  Based on the quantitative difference in TRR and the comparison of the metabolite patterns from both labels, the study authors suggested that the metabolite TFA originate from an uptake of the metabolite or a precursor molecule from the soil into the plants.

Conclusions:  The submitted confined rotational crop study is adequate to satisfy data requirements.  The metabolism of saflufenacil in rotational crops appears to be consistent with the pathway observed in the plant metabolism studies.  The HED ROCKS determined that residues of concern for rotational crops consist of saflufenacil, M800H11, and M800H35 (Memo, B. Daiss, 1/6/09; D359645).

860.1900 Field Accumulation in Rotational Crops

DER Reference List	47128018.der.doc

The field rotational study was conducted in NAFTA Growing Regions 2 (3 trials in GA) and 10 (three trials in CA).  Saflufenacil (70% WG, formulation code BAS 800 00 H) was applied as a single pre-emergence application to the soil, after planting of the primary crop wheat, at 0.132-0.137 lb ai/A (1X).  The representative rotational crops radish, lettuce, and wheat (spring and winter) were grown at PBIs of 4 months (119-125 days), 6 months (180-183 days), and 9 months (270-274 days).  All rotational crop samples were harvested at commercial maturity, 34-169 days after planting (DAP) for radish, 39-187 DAP for lettuce, 59-147 DAP for forage and hay, and 121-223 DAP for grain and straw.  All collected samples were promptly frozen on the date of harvest.

The crop samples were analyzed for residues of saflufenacil and its metabolites M800H11 and M800H35 using LC-MS/MS method BASF Analytical Method D0603.  The LOQ is 0.01 ppm each for parent saflufenacil and its metabolites M800H11 and M800H35 in crop samples, except for wheat forage, hay, and straw, for which the LOQs are 0.025 ppm per analyte.

Residues of saflufenacil and its metabolites M800H11 and M800H35 were all below the LOQ in rotated wheat (<0.025 ppm for wheat forage, hay, and straw, <0.01 ppm for grain), radish (<0.01 ppm, top and roots), and lettuce (<0.01 ppm, leaves).

Conclusions:  The submitted field rotational crop data are adequate to satisfy data requirements.  The available data indicate that residues of saflufenacil and its metabolites M800H11 and M800H35 were each <LOQ in/on all rotational crop matrices at a 120-day PBI.  These data support the labeled rotational crop restriction of 4 months for all non-labeled crops.  Unless the petitioner requests PBIs shorter than 120 days, no additional data are required, and tolerances for inadvertent residues in/on rotational crops need not be established in conjunction with the currently proposed uses.

860.1550 Proposed Tolerances

BASF has proposed a tolerance expression for crops in terms of “the combined residues of saflufenacil (N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dih ydro-1(2H)-pyrimidinyl)benzoyl]-N-isopropyl-N-methylsulfamide) plus metabolites M800H11 (N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidi nyl)-4-fluorobenzoyl]-N'-isopropylsulfamide) and M800H35 (N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}carbonyl)pheny l]urea)”; and for livestock, in terms of saflufenacil, per se.  HED has determined that the tolerance expression for plant commodities should be revised to:  “the combined residues saflufenacil (2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-py rimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide) plus metabolites N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidin yl)-4-fluorobenzoyl]-N'-isopropylsulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}carbonyl)phenyl ]urea, calculated as saflufenacil equivalents.”

A summary of the recommended tolerances for the current petition are listed in Table 35.  The petitioner should submit a revised section F reflecting the recommended tolerances and commodity definitions presented in Table 35.

There are no Codex, Canadian, or Mexican MRLs established for residues of saflufenacil and its metabolites in crop or livestock commodities.

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels for sunflower seed; see Appendix II for tolerance calculations.  A detailed discussion of the assessment of livestock commodity tolerances is presented in the “860.1480 Meat, Milk, Poultry, and Eggs” section of this Summary Document.

Table 35.  Tolerance Summary for Saflufenacil.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Correct Commodity Definition/Comments

Vegetable, legume, group 06	0.03	0.03	Vegetable, legume, group 6

Vegetable, foliage of legume, group 07	0.1	0.10	Vegetable, foliage of legume, group 7

Fruit, citrus, group 10	0.03	0.03

	Fruit, pome, group 11	0.03	0.03

	Fruit, stone, group 12	0.03	0.03

	Nut, tree, group 14	0.03	0.03

	Pistachio	-	0.03	Translated from tree nuts

Almond, hulls	0.2	0.10

	Grain, cereal, group 15	0.03	0.03

	Grain, cereal, forage, fodder and straw group 16	0.1	0.10

	Sorghum stover	0.1	-	Included in crop group 16

Cotton, undelinted seed	0.03	0.03

	Cotton, gin byproducts	0.03	0.10

	Sunflower, seed	0.7	1.0

	Grape	0.03	0.03

	Animal - Kidney	0.02	-	Individual tolerances required for each species

Animal - Liver	0.8	-

	Milk	-	0.01

	Cattle, meat	-	0.01

	Cattle, fat	-	0.01

	Cattle, liver	-	0.80

	Cattle, meat byproducts, except liver	-	0.02

	Goat, meat	-	0.01

	Goat, fat	-	0.01

	Goat, liver	-	0.80

	Goat, meat byproducts, except liver	-	0.02

	Hog, meat	-	0.01

	Hog, fat	-	0.01

	Hog, liver	-	0.80

	Hog, meat byproducts, except liver	-	0.02

	Sheep, meat	-	0.01

	Sheep, fat	-	0.01

	Sheep, liver	-	0.80

	Sheep, meat byproducts, except liver	-	0.02

	Horse, meat	-	0.01

	Horse, fat	-	0.01

	Horse, liver	-	0.80

	Horse, meat byproducts, except liver	-	0.02

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Chemical Name and Structure Table

Appendix II - Tolerance Assessment Calculations

cc:  G. Kramer (RAB1)

RDI:  RAB1 Chemists (1/28/09), HED ChemSAC (2/18/09)

G.F. Kramer:S10781:PY-S:(703)305-5079:7509P:RAB1

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  2-Chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyr imidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino] sulfonyl]benzamide Common Name:

Saflufenacil (experimental code:  BAS 800 H)	( Proposed tolerance

 Reevaluated tolerance

 Other	Date: 1/15/09

Codex Status (Maximum Residue Limits)	U.S. Tolerances

( No Codex proposal step 6 or above

 Codex proposal step 6 or above for the crops requested	Petition Numbers:  PP#8F7322

DP#:  349938

Other Identifier:  PC Code 118203

Residue definition (step 8/CXL):  N/A	Reviewer/Branch:  G. Kramer/RAB1

	Residue definition:  saflufenacil plus metabolites M800H11 and M800H35   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

Crop (s)	MRL (ppm)	Crop(s) 	Tolerance (ppm)

Vegetable, legume, group 06	0.03

Vegetable, foliage of legume, group 07	0.1

Fruit, citrus, group 10	0.03

Fruit, pome, group 11	0.03

Fruit, stone, group 12	0.03

Stone fruit, crop group 12	0.03

Nut, tree, group 14	0.03

Almond, hulls	0.2

Grain, cereal, group 15	0.03

Grain, cereal, forage, fodder and straw group 16	0.1

Sorghum stover	0.1

Cotton, undelinted seed	0.03

Cotton, gin byproducts	0.03

Sunflower, seed	0.7

Grape	0.03

Animal - Kidney	0.02

Animal - Liver	0.8

	Limits for Canada	Limits for Mexico

(   No Limits

   No Limits for the crops requested	(   No Limits

   No Limits for the crops requested

Residue definition  N/A	Residue definition:  N/A

Crop(s)	MRL (ppm)	Crop(s)	MRL (ppm)

	Notes/Special Instructions:  S. Funk, 01/19/2009.

APPENDIX I.	Chemical Names and Structures of Saflufenacil and Metabolites.

Common name/code

Figure C.3.1  ID No.	Chemical name	Chemical structure

Saflufenacil 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyr imidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]

sulfonyl]benzamide

M800H01 N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihy dro-1(2H)-pyrimidinyl)benzoyl]-N-isopropylsulfamide

M800H02 N'-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidi nyl)-4-fluorobenzoyl]-N-isopropyl-N-methylsulfamide

M800H03 N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihy dro-1(2H)-pyrimidinyl)benzoyl]-N-methylsulfamide

M800H04 (2E)-3-{4-chloro-2-fluoro-5-[({[isopropyl(methyl)amino]sulfonyl}amino)ca rbonyl]phenyl)amino]carbonyl(methylamino)}-4,4,4-trifluorobut-2-enoic acid

M800H05 N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihy dro-1(2H)-pyrimidinyl)benzoyl]-sulfamide

M800H07 N-{4-chloro-2-fluoro-5-[({[isopropyl(methyl)amino]sulfonyl}amino)

ༀ銄ᄄ溄ㇻĤ葞Ғ葠ﭮ摧庽	̀Ȥ␱愁Ȥ摧庽

'

(

)

*

+

1

2

D

E

Y

܀Y

Z

[

`

a

c

o

p

r

t

u

z

~

€

‚

ƒ

„

…

‹

Œ

Ž

‘

™

›

¦

§

¨

¯

°

؀°

±

²

´

¹

º

»

½

Ã

È

Î

Ï

Ñ

×

Ü

Þ

â

ã

ä

å

ë

ð

ò

ó

ô

ø

ú

-

„Ð^„Â`„Ðgd%

-

.

?

A

3-

.

@

A

$

$

$

$

 h.

h™

h™

@

摧竬)

摧竬)

摧竬)

摧竬)

摧竬)

摧竬)

摧竬)

摧竬)

@

$

@

@

$

@

$

@

$

@

$

@

$

@

@

$

@

$

@

$

@

@

$

@

$

@

$

@

@

$

@

$

@

$

@

@

@

$

@

$

@

$

@

$

@

@

$

@

$

@

$

@

@

$

@

$

@

$

@

@

$

@

$

@

$

@

@

$

@

$

@

$

@

㄀Ĥ摧庽

ԀĤ␆ഁ׆Ā褐㄀Ĥ摧ៈî

hÁ

愀Ĥ摧嘁

ˆÿ+

$`	£

ˆÿ+

£

ˆÿ+

£

愀Ĥ摧嘁

ˆÿ+

$`	£

ˆÿ+

£

  hMa

  hÌX

 hÁ

ˆÿ+

$`	£

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

ˆÿ+

£

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

愀Ĥ摧ᙓ>

*

ˆÿ+

$`	£

ˆÿ+

£

	ˆÿ+

£

愀Ĥ摧嘁

ˆÿ+

$`	£

ˆÿ+

£

ˆÿ+

£

愀Ĥ摧嘁

愀Ĥ摧嘁

*

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

ˆÿ+

£

  h@)

h.

gd.

gd.

h.

h.

h.

h.

h.

h.

h.

 h.

h.

h.

h.

h.

h.

h.

h.

h.

h.

摧嘁

‡

‡

‡

愀Ĥ摧嘁

	`

	`

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧嘁

愀Ĥ摧ࣅ®

愀Ĥ摧ࣅ®

愀Ĥ摧ࣅ®

晆䦓

愀Ĥ摧ࣅ®

hÛ

#

$

H

I

摧✯n

ԀĤ␆ഁ׆Ā褐㄀Ĥ摧栛¢

&

,

-

0

y

z

~

…

!

"

#

$

7

G

H

I

™

š

摧✯n

 h

@

@

@

@

@

@

 h

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

@

	@

	@

@

	@

愀Ĥ摧庴Z

愀Ĥ摧庴Z

N

N

N

N

N

N

N

 h—

â

â

â

â

$

â

â

 h

 h

  h

 h

H* h

H*

H* h

 h

 h

 h

 h

 h

 h

h&

H*

 h

 h

 h

 h

 h

 h

 h

 h

 h

  h

 h

H* h

 h

š

 h

 h

  h

 h

H*

 h

 h

 h

  h

Ff

H* h

 h

 h

  h

h(?

 h(?

Ffà

摧㼨

hÙ

hÙ

h(?

h(?

h(?

h(?

h(?

  h(?

h(?

 h(?

 h(?

h(?

hÙ

hÙ

h(?

h(?

h(?

摧㼨

摧商

ԀĤ␆ഁ׆Ā褐㄀Ĥ摧惙Y

 h}

  h}

h}

 h}

  h}

摧ᧁ°

[

 h}

  h}

摧ӌ¥

 h}

  h}

 h(?

 h}

  h}

 h}

  h}

 h(?

摧稧f

 h(?

 h}

  h}

  h}

 h(?

 h}

 hr

 h

 h

 h

 h

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

摧拴Ü

摧拴Ü

j

M800H34

M800H35	N-[4-chloro-2-fluoro-5-({[(isopropylamino)

sulfonyl]amino} carbonyl)phenyl]

M800H37	N-{4-chloro-2-fluoro-5-[({[ethyl(methyl)amino]sulfonyl}amino)

Appendix II.  Tolerance-Assessment Calculations.

Sunflower

The dataset used to establish a tolerance for saflufenacil and its metabolites on sunflower seed consisted of sunflower field trial data representing application rates of 0.088-0.090 lb ai/A with a 7- to 14-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate.  In three of the trials, residues were higher at PHIs (10-14 days) that are greater than the proposed PHI (7 days).  In these cases, the higher values were entered into the spreadsheet.  The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II-1.

All 8 field trial sample results were above the combined LOQ of 0.03 ppm.  Since there were no values (combined residues) reported below the LOQ, maximum-likelihood estimation (MLE) procedures were not needed to impute censored values.

The saflufenacil sunflower seed dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP.  Visual inspection of the lognormal probability plot (Figure II-1) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-2) confirmed that the assumption of lognormality should not be rejected.

Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the lognormal EU Method I and the point estimate of the 99th percentile round to the value 1.0 ppm (Figure II-2).  Therefore, 1.0 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on sunflower seed.

Table II-1.	Residue Data Used to Calculate Tolerance for Combined Total Residues of Saflufenacil in/on Sunflower Seed.

Chemical:	Saflufenacil

Crop:	Sunflower

PHI:	7-14 Days

App. Rate:	0.088-0.090 lb ai/A

Submitter:	BASF

MRID Citation:	MRID 47128226

	Total Residues of Saflufenacil

	0.280

	0.150

	0.120

	0.120

	0.470

	0.440

	0.170

	0.170

	0.580

	0.420

	0.100

	0.100

	0.270

	0.150

	0.110

	0.050

Figure II-1.  Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Sunflower Seed.

Figure II-2.  Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Sunflower Seed.

Saflufenacil	Summary of Analytical Chemistry and Residue Data	DP#:  349938

Page   PAGE  1  of   NUMPAGES  67

soil

metabolites

soil

metabolites


[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Rules and Regulations]
[Pages 20508-20511]
[FR Doc No: 2012-8163]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0821; Directorate Identifier 2010-NE-30-AD;
Amendment 39-17004; AD 2012-06-23]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for all Rolls-Royce plc (RR) RB211-Trent 875-17, RB211-Trent 877-17,
RB211-Trent 884-17, RB211-Trent 884B-17, RB211-Trent 892-17, RB211-
Trent 892B-17, and RB211-Trent 895-17 turbofan engines. That AD
currently requires initial and repetitive ultrasonic inspections (UIs)
of certain low-pressure (LP) compressor blades identified by serial
number (S/N). This AD requires the same actions but expands the
population of blades. This AD was prompted by RR concluding that
additional blades affected must be inspected. We are issuing this AD to
prevent LP compressor blades from failing due to blade root cracks,
which could lead to uncontained engine failure and damage to the
airplane.

DATES: This AD is effective April 20, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of April 20,
2012.
    We must receive any comments on this AD by May 21, 2012.

ADDRESSES: You may send comments by any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Rolls-Royce
plc, Corporate Communications, P.O. Box 31, Derby, England, DE248BJ,
telephone: 011-44-1332-242424; fax: 011-44-1332-245418, or email:http://www.rolls-royce.com/contact/civil_team.jsp. You may review copies of
the referenced service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA. For
information on the availability of this material at the FAA, call 781-
238-7125.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Alan Strom, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On April 1, 2011, we issued AD 2011-08-07, Amendment 39-16657 (76
FR 24798, May 3, 2011), for all RR RB211-Trent 875-17, RB211-Trent 877-
17, RB211-Trent 884-17, RB211-Trent 884B-17, RB211-Trent 892-17, RB211-
Trent 892B-17, and RB211-Trent 895-17 turbofan engines. On September 9,
2011, we also issued a correction (76 FR 59013, September 23, 2011) to
that AD. That AD requires initial and repetitive UIs of certain LP
compressor blades identified by S/N. That AD resulted from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. We issued that AD to prevent LP
compressor blades from failing due to blade root cracks, which could
lead to uncontained engine failure and damage to the airplane.

Actions Since AD Was Issued

    Since we issued AD 2011-08-07 (76 FR 24798, May 3, 2011), RR
determined that additional S/Ns of LP compressor blades are affected
and require inspection. EASA has also issued AD 2012-0025, dated
February 8, 2012, to expand the population of affected LP compressor
blades operating in Europe. About 2,300 of the added blades require
inspection within 70 cycles of the effective date of the AD since those
blades have more fatigue damage from prior use.
    This superseding AD differs from EASA AD 2012-0025. This AD only
requires inspection of LP compressor blades that are listed in
Appendices 3A through 3G of RR Alert Service Bulletin (ASB) No. RB.211-
72-AG244, Revision 4, dated December 22, 2011. We are developing
another AD to require inspection of LP compressor blades listed in
Appendices 3H through 3L of RR ASB No. RB.211-72-AG244, Revision 4,
dated December 22, 2011.

Relevant Service Information

    We reviewed Rolls-Royce plc ASB No. RB.211-72-AG244, Revision 4,
dated December 22, 2011. The service information describes procedures
for performing UIs of the LP compressor blades.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information described previously except that this AD only requires
inspection of LP compressor blades that are listed in Appendices 3A
through 3G of RR ASB No. RB.211-72-AG244, Revision 4, dated December
22, 2011.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because about
2,300 LP compressor blades require inspection within 70 cycles after
the effective date of the AD. This equates to about one month's time
for Trent 800 engines flying two flights per day. Therefore, we find
that notice and opportunity for prior public comment are impracticable
and that good cause exists for making this amendment effective in less
than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
the docket number FAA-2010-0821 and directorate identifier 2010-NE-30-
AD at the beginning of your comments. We specifically invite comments
on the overall regulatory, economic, environmental, and energy aspects
of this AD. We will consider all comments received by the closing date
and may amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    Based on the service information, we estimate that this AD will
affect about 158 engines installed on airplanes of U.S. registry. We
also estimate that it will take about 3 hours per engine inspection,
and six inspections per year. The average labor rate is $85 per work-
hour. We estimate that one LP compressor blade per year will need
replacement, at a cost of about $82,000. Based on these figures, we
estimate the annual cost of the AD on U.S. operators to be $323,740.
Our cost estimate is exclusive of possible warranty coverage.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2011-08-07, Amendment 39-16657 (76 FR 24798, May 3, 2011) and adding
the following new AD:

2012-06-23 Rolls-Royce plc: Amendment 39-17004; Docket No. FAA-2010-
0821; Directorate Identifier 2010-NE-30-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 20,
2012.

(b) Affected ADs

    This AD supersedes AD 2011-08-07, Amendment 39-16657 (76 FR
24798, May 3, 2011).

(c) Applicability

    This AD applies to Rolls-Royce plc (RR) RB211-Trent 875-17,
RB211-Trent 877-17, RB211-Trent 884-17, RB211-Trent 884B-17, RB211-
Trent 892-17, RB211-Trent 892B-17, and RB211-Trent 895-17 turbofan
engines.

(d) Unsafe Condition

    This AD was prompted by the determination by RR that additional
serial numbers (S/Ns) of low-pressure (LP) compressor blades are
affected and need to be inspected. We are issuing this AD to prevent
LP compressor blades from failing due to blade root cracks, which
could lead to uncontained engine failure and damage to the airplane.

(e) Actions and Compliance

    Unless already done, do the following actions.
    (1) Perform an initial ultrasonic inspection (UI) of the
affected LP compressor blades identified by S/N in Appendices 3A
through 3G of RR Alert Service Bulletin (ASB) No. RB.211-72-AG244,
Revision 4, dated December 22, 2011. Use Table 1 of this AD to
determine your initial inspection threshold.

                 Table 1--Initial Inspection Thresholds
------------------------------------------------------------------------
Appendix number of RR ASB No. RB.211-72-
   AG244, revision 4, that identifies
  affected LP compressor blades by S/N     Initial inspection threshold

------------------------------------------------------------------------
3A and 3B..............................  Within 70 flight cycles after
                                          the effective date of this AD.
3C.....................................  Within 10 months after the
                                          effective date of this AD.
3D.....................................  Within 22 months after the
                                          effective date of this AD.
3E.....................................  Within 34 months after the
                                          effective date of this AD.
3F.....................................  Within 46 months after the
                                          effective date of this AD.
3G.....................................  Within 58 months after the
                                          effective date of this AD.
------------------------------------------------------------------------

     (2) Thereafter, perform repetitive UIs of the affected LP
compressor blades within every 100 flight cycles.
    (3) Use paragraphs 3.A.(1) through 3.A.(2) of Accomplishment
Instructions of RR ASB No. RB.211-72-AG244, Revision 4, dated
December 22, 2011, and paragraphs 1 through 3.B. of Appendix 1 of
that ASB, or paragraphs 3.B.(1) through 3.B.(3) of Accomplishment
Instructions of RR ASB No. RB.211-72-AG244, Revision 4, dated
December 22, 2011, and paragraphs 1 through 3.C. of Appendix 2 of
that ASB, to perform the UIs.
    (4) Do not return to service any engine with blades that failed
the inspection required by this AD.
    (5) For blades that are removed from the engine and pass
inspection, re-apply dry film lubricant, and install all blades in
their original position.
    (6) After the effective date of this AD, do not install any
affected LP compressor blade unless it has passed the initial and
repetitive UIs required by this AD.

(f) Credit for Previous Actions

    You may take credit for the initial inspection that is required
by paragraph (e)(1) of this AD if you performed the initial
inspection before the effective date of this AD using RR ASB No.
RB.211-72-AG244, dated August 7, 2009; ASB No. RB.211-72-AG244,
Revision 1, dated January 26, 2010; ASB No. RB.211-72-AG244,
Revision 2, dated August 18, 2011; or ASB No. RB.211-72-AG244,
Revision 3, dated December 13, 2011.

(g) FAA AD Differences

    This AD differs from EASA AD 2012-0025, dated February 8, 2012.
That AD requires inspecting LP compressor blades that are listed in
Appendices 3A through 3L of RR ASB No. RB.211-72-AG244, Revision 4,
dated December 22, 2011, whereas this AD only requires inspection of
LP compressor blades that are listed in Appendices 3A through 3G of
the ASB.

(h) Alternative Methods of Compliance

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(i) Related Information

    (1) For more information about this AD, contact Alan Strom,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to EASA AD 2012-0025, dated February 8, 2012, for
related information.

(j) Material Incorporated by Reference

    (1) You must use Rolls-Royce plc Alert Service Bulletin No.
RB.211-72-AG244, Revision 4, dated December 22, 2011,

Appendix 1, Appendix 2, and Appendices 3A through 3G of that ASB, to
do the actions required by this AD, unless the AD specifies
otherwise. The Director of the Federal Register approved the
incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE248BJ, telephone: 011-44-1332-242424; fax: 011-44-1332-
245418, or email: http://www.rolls-royce.com/contact/civil_team.jsp.
    (3) You may review copies of the service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr_locations.html.

    Issued in Burlington, Massachusetts, on March 20, 2012.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2012-8163 Filed 4-4-12; 8:45 am]
BILLING CODE 4910-13-P