[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70879-70880]
[FR Doc No: 2014-28086]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1862]

Recommended Warning for Over-the-Counter Acetaminophen-Containing
Drug Products and Labeling Statements Regarding Serious Skin Reactions;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Recommended
Warning for Over-the-Counter Acetaminophen-Containing Drug Products and
Labeling Statements Regarding Serious Skin Reactions.'' The draft
guidance is intended to inform manufacturers, members of the medical
and scientific community, and other interested persons that at this
time we do not intend to object to the marketing of single- and
combination-ingredient, acetaminophen-containing, nonprescription
(commonly referred to as over-the-counter (OTC)) drug products bearing
a warning as described in the draft guidance alerting consumers that
the use of acetaminophen may cause severe skin reactions.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final guidance, submit
either electronic or written comments on the draft guidance by January
27, 2015.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sudha Shukla, Office of Unapproved
Drugs and Labeling Compliance, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Recommended Warning for Over-the-Counter Acetaminophen-
Containing Drug Products and Labeling Statements Regarding Serious Skin
Reactions.'' Acetaminophen, included in many prescription and OTC
products, is a common active ingredient indicated to treat pain and
reduce fever. On August 1, 2013, FDA issued a Drug Safety Communication
(DSC) informing the public that use of acetaminophen has been
associated with a risk of rare but serious skin reactions.\1\ These
skin reactions, including Stevens-Johnson Syndrome, toxic epidermal
necrolysis, and acute generalized exanthematous pustulosis, can be
fatal.
---------------------------------------------------------------------------

    \1\ FDA Drug Safety Communication: FDA warns of rare but serious
skin reactions with the pain reliever/fever reducer acetaminophen.
http://www.fda.gov/Drugs/DrugSafety/ucm363041.htm.
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    The DSC explained that reddening of the skin, rash, blisters, and
detachment of the upper surface of the skin can occur with the use of
drug products that contain acetaminophen. These skin reactions can
occur with the first-time use of acetaminophen or at any time while it
is being taken. FDA advised health care professionals to be aware of
this rare risk and consider acetaminophen, along with other drugs
already known to have such an association, when assessing patients with
potentially drug-induced skin reactions. FDA also advised that anyone
who develops a skin rash or reaction while using acetaminophen or any
other pain reliever/fever reducer should stop taking the drug and seek
medical attention right away. Furthermore, the announcement advised
that anyone who has experienced a serious skin reaction when taking
acetaminophen in the past should not take the drug again and should
contact their health care professional to discuss alternative pain
relievers/fever reducers.
    In the announcement, FDA stated that it planned to require
manufacturers of acetaminophen-containing prescription

drug products to include a warning statement on the product labels to
address the risk of serious skin reactions and that it would request
the same warning be added by manufacturers of OTC acetaminophen-
containing drug products marketed under an approved application. In the
fall of 2013, FDA sent letters to manufacturers holding new drug
applications (NDA) and abbreviated new drug applications (ANDA)
requiring in some cases and requesting in others that the language
recommended below be included on the labeling for all products (both
prescription and OTC) containing acetaminophen marketed under NDAs and
ANDAs. At this time, most of the requested labeling changes have been
made by the relevant manufacturers.
    FDA also indicated that it planned to encourage manufacturers of
acetaminophen-containing drug products marketed under the Tentative
Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic
Drug Products for Over-the-Counter Human Use, published in the Federal
Register (53 FR 46204, November 16, 1988) to similarly add a warning
about serious skin reactions to the product labels. As noted above,
this draft guidance informs manufacturers, members of the medical and
scientific community, and other interested persons that at this time we
do not intend to object to the marketing of single- and combination-
ingredient, acetaminophen-containing, nonprescription (commonly
referred to as OTC) drug products bearing a warning as described in the
draft guidance alerting consumers that the use of acetaminophen may
cause severe skin reactions.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the
recommended warning for OTC acetaminophen-containing drug products and
labeling statements regarding serious skin reactions. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    Under the draft guidance, manufacturers may add to their drug
product labeling a warning statement supplied by FDA that pertains to
acetaminophen to address the risk of serious skin reactions. Inclusion
of the warning statement on the labels for these drug products would be
exempt from review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) because the
public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the public
is not included within the definition of ``collection of information''
(see 5 CFR 1320.3(c)(2)).

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 21, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28086 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 2, 2007 (Volume 72, Number 190)]
[Notices]
[Page 56109-56110]
[DOCID:fr02oc07-84]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold the following meetings during the
week of October 1, 2007:
    An Open Meeting will be held on Monday, October 1, 2007 at 10 a.m.,
in the Auditorium, Room L-002 and a Closed Meeting will be held on
Wednesday, October 3, 2007 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (7), (9)(B), and (10) and 17 CFR 200.402(a)(5),
(7), 9(ii) and (10), permit consideration of the scheduled matters at
the Closed Meeting.
    Commissioner Atkins, as duty officer, voted to consider the items
listed for the closed meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the Open Meeting, scheduled for Monday,
October 1, 2007 will be:

    The Commission will hear oral argument in an appeal by Stephen
J. Horning from the decision of an administrative law judge. Horning
was the president, registered financial and operations principal,
compliance officer, and a director of Rocky Mountain Securities &
Investments, Inc., formerly a registered broker-dealer.
    The law judge found that:
    Horning failed reasonably to supervise two former Rocky Mountain
employees with a

view to preventing their violations of Section 10(b) of the
Securities Exchange Act of 1934 and Exchange Act Rule 10b-5; and
    Horning was a cause of Rocky Mountain's inaccurate books and
records and its filing of materially false reports in violation of
Exchange Act Sections 15(c)(3), 17(a), and 17(e) and Exchange Act
Rules 15c3-1, 15c3-3, 17a-3, 17a-5(a), 17a-5(c), 17a-5(d), 17a-11,
and 17a-13.

    The law judge barred Horning from association with any broker or
dealer in a supervisory capacity and suspended him from association
with any broker or dealer in any capacity for twelve months.
    Among the issues likely to be argued are
    1. Whether Horning failed reasonably to supervise; or
    2. Whether Horning was the cause of the alleged financial, books,
and recordkeeping violations; and
    3. If so, whether sanctions should be imposed in the public
interest.
    The subject matter of the Closed Meeting scheduled for Wednesday,
October 3, 2007 will be:
    Formal order of investigation;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature;
    An adjudicatory matter; and
    Other matters related to enforcement actions.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: September 26, 2007.
Nancy M. Morris,
Secretary.
 [FR Doc. E7-19384 Filed 10-1-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 74, Number 84 (Monday, May 4, 2009)]
[Notices]
[Pages 20475-20476]
[FR Doc No: E9-10105]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1020-000]

Panoche Energy Center, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

April 24, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Panoche Energy Center, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC, 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and

assumptions of liability, is May 12, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC, 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-10105 Filed 5-1-09; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Proposed Rules]
[Pages 24856-24858]
[FR Doc No: 2015-09930]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0277; Directorate Identifier 2015-NE-05-AD]
RIN 2120-AA64

Airworthiness Directives; CFM International S.A. Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain CFM International S.A. (CFM) CFM56-7B series turbofan engines.
This proposed AD was prompted by reports of uncommanded in-flight
shutdowns (IFSDs) on CFM CFM56-7B engines following rupture of the 73-
tooth gearshaft located in the engine accessory gearbox (AGB). This
proposed AD would require magnetic chip detector (MCD) inspection of
the affected gearshafts until removal. We are proposing this AD to
prevent failure of certain engine AGB gearshafts, which could lead to
failure of one or more engines, loss of thrust control, and damage to
the airplane.

DATES: We must receive comments on this proposed AD by June 30, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact CFM
International Inc., Aviation Operations Center, 1 Neumann Way, M/D Room
285, Cincinnati, OH 45125; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>You may view this 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>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0277; 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 proposed 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: Kyle Gustafson, 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>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2015-0277;
Directorate Identifier 2015-NE-05-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    We have received reports of uncommanded IFSDs on CFM CFM56-7B
engines following rupture of the 73-tooth gearshaft located in the
engine AGB. CFM has identified an affected population of 73-tooth
gearshafts that show premature wear on the teeth due to inadequate shot
peening. In the process of its investigation, CFM identified an
additional population of 41-tooth gearshafts that is subject to the
same premature wear. The affected population of 73-tooth and 41-tooth
gearshafts exhibit a surface finish that leads to loss in oil film
effectiveness, causing micro-pitting which eventually

leads to material separating from the gearshaft and its eventual
failure.
    The proposed AD requires enhanced MCD inspection until removal of
the gearshaft. This enhanced inspection requires that any material,
including fuzz, be sent to the particles lab for analysis to determine
the source of the material. We are allowing affected engines to
continue to operate for 75 flight hours (FHs) after the MCD inspection
to provide sufficient time to determine the source of the material and
to remove the affected gearshaft if the particles lab analysis finds
that the source of the material is from an affected 73-tooth or 41-
tooth gearshaft. The enhanced MCD inspection and particles lab analysis
is repeated every 500 FHs after the initial MCD inspection until the
affected gearshaft is removed from service. This condition, if not
corrected, could result in failure of certain engine AGB gearshafts,
which could lead to failure of one or more engines, loss of thrust
control, and damage to the airplane.

Relevant Service Information Under 1 CFR Part 51

    We reviewed CFM Service Bulletin (SBs) CFM56-7B S/B 72-0964,
Revision 1, dated December 15, 2014, and CFM56-7B S/B 72-0965, dated
December 16, 2014. The SBs describe procedures for removal of affected
73-tooth and 41-tooth gearshafts. This service information is
reasonably available; see ADDRESSES for ways to access this service
information.

FAA's Determination

    We are proposing 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.

Proposed AD Requirements

    This proposed AD would require an MCD inspection within 250 FHs
since last inspection or within 25 FHs after the effective date of this
AD, whichever comes later. The proposed AD would also require that the
MCD inspection be repeated every 500 FHs after the initial MCD
inspection until removal of the affected gearshaft. The proposed AD
would also require as terminating action that the affected gearshafts
be removed.

Differences Between This Proposed AD and the Service Information

    This proposed AD would require an MCD inspection 250 FHs since last
inspection or within 25 FHs after the effective date of this AD,
whichever comes later. CFM SB CFM56-7B S/B 72-0964, Revision 1, dated
December 15, 2014, recommends performing a MCD inspection 250 FHs since
last inspection or as soon as possible if the inspection was done more
than 250 FHs ago.
    In this proposed AD, we are not requiring that operators send the
particles to CFM for analysis. We are, however, requiring that
operators determine if the particles are 73-tooth gearshaft or 41-tooth
gearshaft material. CFM56-7B S/B 72-0964 recommends that if any
magnetic particles, including fuzz are seen, operators send the
inspection results and lab analysis to CFM for disposition.

Costs of Compliance

    We estimate that this proposed AD would affect about 67 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 1 hour per engine to do the inspection and 8 hours per
engine to replace each affected gearshaft. We estimate thirty-six 73-
tooth gearshafts and forty 41-tooth gearshafts will need replacement at
a cost of $12,480 and $7,680 per part, respectively. The average labor
rate is $85 per hour. Based on these figures, we estimate the cost of
the proposed AD on U.S. operators to be $813,855.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

CFM International S.A.: Docket No. FAA-2015-0277; Directorate
Identifier 2015-NE-05-AD.

(a) Comments Due Date

    We must receive comments by June 30, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to CFM International S.A. (CFM) CFM56-7B engines
with accessory gearboxes (AGBs), with 73-tooth gearshafts or 41-
tooth gearshafts, identified in Appendix A and Appendix B of CFM
Service Bulletin (SB) CFM56-7B S/B 72-0964, Revision 1, dated
December 15, 2014.

(d) Unsafe Condition

    This AD was prompted by reports of uncommanded in-flight
shutdowns on CFM CFM56-7B engines following rupture of the 73-tooth
gearshaft located in the engine AGB. We are issuing this AD to
prevent failure of certain AGB gearshafts, which could lead to
failure of one or more engines, loss of thrust control, and damage
to the airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Initial Magnetic Chip Detector (MCD) Inspection and
Analysis. (i) For affected 73-tooth gearshafts, perform an MCD
inspection within 250 flight hours (FHs) since last inspection,
within 25 FHs from the effective date of this AD, or when the
gearshaft accumulates 3,000 FHs since new, whichever comes later.
    (ii) For affected 41-tooth gearshafts, perform an MCD inspection
within 250 FHs since last inspection, within 25 FHs from the
effective date of this AD, or when the gearshaft accumulates 6,000
FHs since new, whichever comes later.
    (iii) If any magnetic particles, including fuzz, are seen,
determine with particles lab analysis if the particles are 73-tooth
or 41-tooth gearshaft material.
    (iv) If the particles are 73-tooth or 41-tooth gearshaft
material, remove the affected gearshaft(s) within 75 FHs since the
MCD inspection.
    (2) Repetitive MCD Inspection and Analysis. (i) For affected 73-
tooth gearshafts, perform an MCD inspection and particles lab
analysis within every 500 FHs since the last MCD inspection until
affected gearshaft is removed.
    (ii) For affected 41-tooth gearshafts, perform an MCD inspection
and particles lab analysis within every 500 FHs since the last MCD
inspection until affected gearshaft is removed.
    (iii) If any magnetic particles, including fuzz, are seen,
determine with particles lab analysis if the particles are 73-tooth
or 41-tooth gearshaft material.
    (iv) If the particles are 73-tooth or 41-tooth gearshaft
material, remove the affected gearshaft(s) within 75 FHs since the
MCD inspection.

(f) Mandatory Terminating Action

    (1) Remove the affected 73-tooth gearshaft prior to the
gearshaft accumulating 6,000 FHs since new or within 50 FHs after
the effective date of this AD, whichever comes later.
    (2) Remove the affected 41-tooth gearshaft prior to the
gearshaft accumulating 9,000 FHs since new or within 50 FHs after
the effective date of this AD, whichever comes later.

(g) Installation Prohibition

    After the effective date of this AD, do not install an affected
gearshaft into an AGB.

(h) Alternative Methods of Compliance (AMOCs)

    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. You may email your request to<EMAIL_ADDRESS>
(i) Related Information

    (1) For more information about this AD, contact Kyle Gustafson,
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) CFM SBs CFM56-7B S/B 72-0964, Revision 1, dated December 15,
2014, and CFM56-7B S/B 72-0965, dated December 16, 2014, can be
obtained from GE using the contact information in paragraph (i)(3)
of this proposed AD.
    (3) For service information identified in this AD, contact CFM
International Inc., Aviation Operations Center, 1 Neumann Way, M/D
Room 285, Cincinnati, OH 45125; phone:<PHONE_NUMBER>; fax: 877-432-
3329; email<EMAIL_ADDRESS>    (4) You may view this 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>.

    Issued in Burlington, Massachusetts, on April 17, 2015.
Thomas A. Boudreau,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2015-09930 Filed 4-30-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Rules and Regulations]
[Pages 45958-45959]
[FR Doc No: 2017-20967]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0321; Airspace Docket No. 17-ASO-11]

Establishment of Class E Airspace; Hattiesburg, MS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace extending upward from
700 feet above the surface at Forrest General Hospital Heliport,
Hattiesburg, MS, to accommodate new area navigation (RNAV) global
positioning system (GPS) standard instrument approach procedures
(SIAPs) serving Forrest General Hospital Heliport. Controlled airspace
is necessary for the safety and management of instrument flight rules
(IFR) operations at the heliport.

DATES: Effective 0901 UTC, December 7, 2017. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11B, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in

Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E airspace at Forrest General Hospital
Heliport, Hattiesburg, MS, to support IFR operations under standard
instrument approach procedures at the heliport.

History

    The FAA published a notice of proposed rulemaking (NPRM in the
Federal Register (82 FR 27448, June 15, 2017) Docket No. FAA-2017-0321
to establish Class E airspace extending upward from 700 feet above the
surface at Forrest General Hospital Heliport, Hattiesburg, MS, due to
the new RNAV (GPS) standard instrument approach procedures for IFR
operations at the heliport. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by establishing Class E airspace extending upward from 700 feet
above the surface within a 6 mile radius of Forrest General Hospital
Heliport, Hattiesburg, MS. This action provides the controlled airspace
required to support the new RNAV (GPS) standard instrument approach
procedures for IFR operations at the Heliport.

Regulatory Notices and Analyses

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

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the FAA amends 14 CFR part 71 as
follows:

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11B, Airspace Designations and Reporting
Points, dated August 3, 2017, effective September 15, 2017, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO MS E5 Forrest General, Hattiesburg, MS [New]

Forrest General Hospital Heliport, MS
    (Lat. 31[deg]19'08'' N., long. 89[deg]19'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6-mile radius of Forrest General Hospital Heliport.

    Issued in College Park, Georgia, on September 22, 2017.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2017-20967 Filed 10-2-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Page 45263]
[FR Doc No: 2023-14999]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-808, OMB Control No. 3235-0740]

Submission for OMB Review; Comment Request; Extension: Joint
Standards for Assessing the Diversity Policies and Practices of
Entities Regulated by the Agencies

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    In accordance with the requirements of Section 342 of the Dodd-
Frank Wall Street Reform and Consumer Protection Act of 2010 (12 U.S.C.
5452), the Commission joined with the Office of the Comptroller of the
Currency, Board of Governors of the Federal Reserve System, Federal
Deposit Insurance Corporation, Bureau of Consumer Financial Protection,
and the National Credit Union Administration (Agencies) to develop
Joint Standards for Assessing the Diversity Policies and Practices of
Entities Regulated by the Agencies (Joint Standards), which were issued
through an interagency policy statement published in the Federal
Register on June 15, 2015. To facilitate the collection of information
envisioned by the Joint Standards, the Commission developed a form
entitled the ``Diversity Self-Assessment Tool for Entities Regulated by
the SEC'' (formerly the ``Diversity Assessment Report'').
    The Diversity Self-Assessment Tool (1) asks for general information
about the respondent; (2) includes a checklist and questions relating
to the policies and practices set forth in the Joint Standards; (3)
requests data related to workforce diversity and supplier diversity;
and (4) provides respondents with the opportunity to describe their
successful policies and practices for promoting diversity and
inclusion.
    The information collection is voluntary. The Commission may use
information submitted to monitor progress and trends in the financial
services industry regarding diversity and inclusion and to identify and
highlight diversity and inclusion policies and practices that have been
successful. In addition, the Commission may publish information
submitted, such as leading practices, in a form that does not identify
a particular entity or disclose confidential business information.
Further, the Commission may share information with other Agencies, when
appropriate, to support coordination of efforts and to avoid
duplication.
    Title of Collection: Joint Standards for Assessing Diversity
Policies and Practices.\1\
---------------------------------------------------------------------------

    \1\ The title of the currently approved collection--Joint
Standards for Assessing the Diversity Policies and Practices of
Entities Regulated by the Agencies-- has been shortened.
---------------------------------------------------------------------------

    Type of Review: Request for a Non-Substantive Change to an Existing
Approved Information Collection.
    Frequency of Response: Biennially.
    Estimated Number of Respondents: 260.
    Estimated Burden Hours per Respondent: 8 hours; 4 hours annualized.
    Estimated Total Annual Burden Hours: 2,080; 1,040 annualized. Since
the last approval of this information collection, we have adjusted the
burden hours per respondent based on a reduction in the number of items
in this information collection.
    Proposed Revisions: The SEC proposes to amend the Diversity Self-
Assessment Tool to: (1) change the name of the information collection
from the ``Diversity Assessment Report'' to the ``Diversity Self-
Assessment Tool''; (2) allow firms to consent to allowing the SEC to
publish the name of consenting firms having submitted a Diversity Self-
Assessment Tool; (3) shorten the Diversity Self-Assessment Tool by
combining and removing some items; (4) add clarifying language to
items; and (5) shorten items for brevity. A draft of the proposed
revised Diversity Self-Assessment Tool can be viewed at https://www.sec.gov/files/omwi-diversity-self-assessment-tool.pdf.
    On May 11, 2023, the Commission published a notice in the Federal
Register (88 FR 30352) of its intention to request an extension of this
currently approved collection of information and allowed the public 60
days to submit comments. The Commission received no comments.
    Written comments continue to be invited on: (a) whether this
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to
[email protected]; and (ii) David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549, or by sending an email
to: [email protected]. Comments must be submitted within 30 days of
this notice.

    Dated: July 11, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-14999 Filed 7-13-23; 8:45 am]
BILLING CODE 8011-01-P


                                     GROUP
27
HERBICIDE

                          Tolpyralate 400SC Herbicide

HERBICIDE

For postemergence weed control in all types of field corn, sweet corn and popcorn.

ACTIVE INGREDIENT:	By Wt.
Tolpyralate*:	 35.7%
OTHER INGREDIENTS:	64.3%
Total...................................................100.0%
* 1-[[1-Ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate

Contains 3.33 pounds active ingredient per gallon of formulated product (400 grams per liter)

                         KEEP OUT OF REACH OF CHILDREN

CAUTION

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (If you do not understand this label, find someone to explain it to you in detail.)

SEE SIDE PANEL FOR FIRST AID AND ADDITIONAL PRECAUTIONARY STATEMENTS.

READ ENTIRE LABEL CAREFULLY AND USE ONLY AS DIRECTED.
EPA REG. NO. 71512-
EPA Establishment No.

Net Contents: xx gallons
							ISK Biosciences Corporation
                                    7470 Auburn Road, Suite A
                                    Concord, Ohio  44077

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS & DOMESTIC ANIMALS
CAUTION
Harmful if swallowed or absorbed through skin. Avoid contact with skin, eyes or clothing.  Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse.

                                   FIRST AID
If swallowed
 Call a poison control center or doctor immediately for treatment advice.
 Have person sip a glass of water if able to swallow.
 Do not induce vomiting unless told to do so by the poison control center or doctor.
 Do not give anything to an unconscious person.
If on skin or
clothing
 Take off contaminated clothing.
 Rinse skin immediately with plenty of water for 15-20 minutes.
 Call a poison control center or doctor for treatment advice.
Have the product container or label with you when calling a poison control center or doctor, or going for treatment.
HOT LINE NUMBER
         For 24-Hour Medical Emergency Assistance call 1-888-484-7546.
[For Chemical Emergency, Spill, Leak, Fire or Accident, call CHEMTREC 1-800-424-9300.]

PERSONAL PROTECTIVE EQUIPMENT (PPE)
Applicators and other handlers must wear: long-sleeved shirt and long pants, shoes plus socks, and waterproof gloves.

USER SAFETY REQUIREMENTS
Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this product's concentrate. Do not reuse them. Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.

--------------------------------------------------------------------------------
USER SAFETY RECOMMENDATIONS
--------------------------------------------------------------------------------
Users should:
--------------------------------------------------------------------------------
Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet.  Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.  Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.
ENVIRONMENTAL HAZARDS
Do not apply directly to water, to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment rinse water. Do not apply where/when conditions could favor runoff.

GROUND WATER ADVISORY

Tolpyralate has properties and characteristics associated with chemicals detected in groundwater.  Tolpyralate may leach into groundwater if used in areas where soils are permeable, particularly where the water table is shallow.

SURFACE WATER ADVISORY

This product may impact surface water quality due to runoff of rain water.  This is especially true for poorly draining soils and soils with shallow ground water.  This product is classified as having high potential for reaching surface water via runoff for several months or more after application.  A level, well-maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential loading of tolypyralate from runoff water and sediment.  Runoff of this product will be reduced by avoiding applications when rainfall or irrigation is expected to occur within 48 hours.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application. For any requirements specific to your State or Tribe, consult the agency responsible for pesticide regulation.

--------------------------------------------------------------------------------
AGRICULTURAL USE REQUIREMENTS
--------------------------------------------------------------------------------
Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170. This Standard contains requirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertaining to the statements on this label about personal protective equipment (PPE) and restricted-entry interval. The requirements in this box only apply to uses of this product that are covered by the Worker Protection Standard.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Do not enter or allow worker entry into treated areas during the Restricted Entry Interval (REI) of 12 hours.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, is: Coveralls, chemical-resistant gloves made of any waterproof materials, and shoes plus socks.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Sod and seed farms are within the scope of the Worker Protection Standard.

Tolpyralate 400SC must be used only in accordance with directions on this label.  To the extent consistent with applicable law, ISK Biosciences Corporation will not be responsible for losses or damage resulting from use of this product in any manner not specifically directed by ISK Biosciences.

PRODUCT INFORMATION

Tolpyralate 400SC is a suspension concentrate used at a rate of 1.0-1.35 fl oz per acre for selective postemergence control of certain grass and broadleaf weeds in field corn, seed corn, sweet corn and popcorn. When applied postemergence, susceptible weeds uptake through treated foliage and cease growth soon after application. Complete death of weeds may take up to 2 weeks but will not compete with the growing crop. Do not make more than two applications of Tolpyralate 400SC per year. The combined dosage of sequential applications must not exceed 2.70 fl oz of Tolpyralate 400SC per acre per year.

Mode of Action
Tolpyralate 400SC is a Group 27 Herbicide that controls weeds by inhibiting HPPD (pigment synthesis) biochemical process.

Crop Tolerance
Tolpyralate 400SC has exhibited excellent crop tolerance in development trials. However, Tolpyralate 400SC has not been tested on all inbred lines for tolerance. Contact your seed corn supplier for specific recommendations.

Insecticide Use Information
Tolpyralate 400SC has no restrictions for registered insecticide use.

RESISTANCE MANAGEMENT
Tolpyralate is an HPPD inhibitor herbicide (Group 27) which inhibits carotenoid biosynthesis in plants. Naturally occurring biotypes of certain weed species with resistance to several herbicide modes of action (triazine (Group 5), ALS (Group 2), PPO (Group 14), glyphosate (Group 9), auxin (Group 4), HPPD (Group 27) and etc.) have been identified. The repeated use of herbicides with the same modes of action allow resistant weeds to be selected and spread. To manage the development and spread of herbicide resistant weed species, it is important to use herbicides with different modes of action either as tank mixes or in sequential applications and in rotations along with altering cultural practices.

To help reduce the development of resistance to HPPD inhibitors (Group 27), always apply the full labeled rate and at the recommended application timing listed on the label. Contact your local sales representative, crop advisor, or extension agent to determine if there is suspected HPPD resistant weeds in your region. If HPPD resistant biotypes of target weeds have been reported, use the specified application rates of this product specified for your conditions and add rank mix products so that there are multiple effective mechanisms of actions for each target weed.

Fields should be scouted prior to application to identify the weed species present and their growth stage to determine if the intended application will be effective. Fields should be scouted after application to verify that the treatment was effective. If suspected weed resistance is observed in a particular weed species contact your retailer representative or call ISK Biosciences at 1-877-706-4640.  Lack of weed control is not necessarily an indicator of weed resistance.

Suspected herbicide resistant weeds may be identified by these indicators:
 Failure to control a weed species normally controlled by the herbicide applied at specified application rates, especially if control is achieved on adjacent weeds.
 The spreading of a patch of a particular weed species that survives a herbicide application; and
 Surviving plants mixed with controlled individuals of the same species.

If resistance is suspected, treat weed escapes with an herbicide having a different mechanism of action and/or use non-chemical means to remove escapes, as practical, with the goal or preventing further seed production.

When applying Tolpyralate 400SC as a postemergence treatment after using an HPPD containing preplant/preemergence herbicide always tank mix tolpyralate with another product with a different mode of action. Atrazine is a preferred tank mix partner and other herbicides can be tank mixed as needed to enhance efficacy.

Cultivation
Avoid disturbing treated areas for at least 7 days after Tolpyralate 400SC application to allow maximum herbicide uptake and translocation. Avoid deep cultivation that will move dormant weed seeds into a zone where germination is likely. This is especially critical when tank mixing with an herbicide with soil residual activity.

ENVIRONMENTAL CONDITIONS AND BIOLOGICAL ACTIVITY
Tolpyralate 400 SC provides best results when applied to young, actively growing weeds. Applications made during warm, moist conditions (70°F or more) and adequate soil moisture both before and after application maximizes performance.

The degree and duration of control depend on spray coverage, weed spectrum, weed size, growing conditions before and after treatment and soil moisture.

Tolpyralate 400SC is rainfast in 1 hour. Treating weeds that exceed maximum label height or that are under stress may result in incomplete control. Poor weed control or crop injury may result from applications made to plants under stress from:
 abnormally hot or cold weather
 environmental conditions such as drought, water-saturated soils, hail damage, or frost
 disease, insect, or nematode injury
 prior herbicide, or carryover from a previous year's herbicide application

If the corn or grass weeds are under stress, delay application until stress passes and both weeds and corn resume active growth.

INTEGRATED PEST MANAGEMENT (IPM)
Tolpyralate 400 SC should be integrated into an integrated pest management strategy whenever the use of an herbicide is required. Practices known to reduce weed development (tillage, crop competition) and herbicides use (weed scouting, proper application timing) should be followed whenever possible. Consult local agricultural and weed authorities for additional IPM strategies specific for your area.

SPRAY DRIFT MANAGEMENT
Do not apply more than 2 feet above the ground or crop canopy.

Applicators are required to use a medium to coarse droplet size.

Do not apply when wind speeds exceed 10 miles per hour at the application site.

Do not apply during temperature inversions.

SPRAY DRIFT ADVISORIES

The interaction of many equipment and weather-related factors determines the potential for spray drift.  The applicator is responsible for considering all these factors when making application decisions.

IMPORTANCE OF DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets.  The best drift management strategy is to apply the largest droplets that provide sufficient coverage and control. The presence of sensitive species nearby, the environmental conditions, and pest pressure may affect how an applicator balances drift control and coverage.  APPLYING LARGER DROPLETS REDUCES DRIFT POTENTIAL, BUT WILL NOT PREVENT DRIFT IF APPLICATIONS ARE MADE IMPROPERLY OR UNDER UNFAVORABLE ENVIRONMENTAL CONDITIONS!  See Wind, Temperature and Humidity, and Temperature Inversions sections of this label.

Controlling Droplet Size
 Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with higher rated flows produce larger droplets.
 Pressure - Use the lower spray pressures recommended for the nozzle.  Higher pressure reduces droplet size and does not improve canopy penetration.  WHEN HIGHER FLOW RATES ARE NEEDED, USE A HIGHER-CAPACITY NOZZLE INSTEAD OF INCREASING PRESSURE.
 Nozzle Type - Use a nozzle type that is designed for the intended application.  With most nozzle types, narrower spray angles produce larger droplets.  Consider using low-drift nozzles.

BOOM HEIGHT
Setting the boom at the lowest referenced height (if specified) which provides uniform coverage reduces the exposure of droplets to evaporation and wind.  For ground equipment, the boom should remain level with the crop and have minimal bounce.

WIND
Drift potential increases at wind speeds of less than 3 mph (due to inversion potential) or more than 10 mph.  However, many factors, including droplet size and equipment type determine drift potential at any given wind speed.  AVOID APPLICATIONS DURING GUSTY OR WINDLESS CONDITIONS.  Note: Local terrain can influence wind patterns.  Every applicator needs to be familiar with local wind patterns and how they affect spray drift.

TEMPERATURE AND HUMIDITY
When making applications in hot and dry conditions, set up equipment to produce larger droplets to reduce effects of evaporation.

TEMPERATURE INVERSIONS
Drift potential is high during a temperature inversion.  Temperature inversions restrict vertical air mixing, which causes small suspended droplets to remain close to the ground and move laterally in a concentrated cloud.  Temperature inversions are characterized by increasing temperature with altitude and are common on nights with limited cloud cover and light to no wind.  They begin to form as the sun sets and often continue into the morning.  Their presence can be indicated by ground fog; however, if fog is not present, inversions can also be identified by the movement of smoke from a ground source or an aircraft smoke generator.  Smoke that layers and moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion, while smoke that moves upward and rapidly dissipates indicates good vertical air mixing.

SHIELDED SPRAYERS
Shielding the boom or individual nozzles can reduce the effects of wind.  However, it is the responsibility of the applicator to verify that the shields are preventing drift and not interfering with uniform deposition of the product.

CALIBRATION
Equipment should be calibrated regularly according to manufacturer's specifications.

MIXING and LOADING INSTRUCTIONS
Prepare no more spray mixture than is needed for the immediate application. Avoid overnight storage of Tolpyralate 400SC in spray mixtures.

1. Ensure the spray system is free of residues from previous applications.
2. Fill the tank 1/2 full of clean water.
3. While agitating, add the required amount of Tolpyralate 400SC.
4. Continue agitation until the Tolpyralate 400SC is completely dispersed, at least 5 minutes.
  Once the Tolpyralate 400SC is fully dispersed, maintain agitation and continue filling tank with water. Thoroughly mix Tolpyralate 400SC with water before adding any other material.
5. As the tank is filling, add the required spray adjuvants (methylated seed oil, crop oil concentrate or ammonium nitrogen fertilizer).
6. If the mixture is not continuously agitated, settling will occur. If settling occurs, thoroughly re-agitate before using.
7. Avoid overnight storage of Tolpyralate 400SC spray mixtures.

For tank mixture mixing instructions see Tank Mixture section below.

Tank Mixtures
Tank mixes are generally used to broaden or extend control of the weed spectrum present.  Tank mix herbicides must be registered for use on the intended crop.  A tank mixture with atrazine is recommended unless atrazine is prohibited in the application area. An application of Tolpyralate 400SC at 1.0 to 1.35 fl oz. per acre in combination with atrazine at least 0.5 lb ai per acre will increase the speed of control, the weed spectrum, and consistency of control. Do not apply atrazine if corn is greater than 12 inches.

Tolpyralate 400SC may be tank mixed with other herbicides specified for use on corn.  Read and follow all label directions for each tank mix herbicide. It is the pesticide user's responsibility to ensure that all products are registered for the intended use. Read and follow the applicable restrictions and limitations and directions for use on all product labels involved in tank mixing. Users must follow the most restrictive directions for use and precautionary statements of each product in the tank mixture.  Tolpyralate 400SC is generally compatible with insecticides (non-organophosphate), fungicides, fertilizers and micronutrient products provided sufficient free water is available for dispersion of all the tank mix products.  However, the physical compatibility of Tolpyralate 400SC with tank mix partners should be evaluated before use. Use tank-mix combinations only when applicator experience indicates that the tank mix will not result in objectionable crop injury.

For tank mixtures, add individual components to the spray tank in the following sequence: water, water dispersible granules, water-soluble bags, dry flowables, emulsifiable concentrates, drift control additives, water-soluble liquids (except in the case of glyphosate or glufosinate which should be added after liquid fertilizer or ammonium sulfate is dispersed), liquid fertilizer and/or ammonium sulfate, and adjuvants.

Compatibility Test
Additives and tank mixes should be tested for compatibility by mixing in a small container prior to mixing in spray tank.

In a glass jar (~1 quart size), add all mix partners, in their relative proportions.  Invert, shake or mix the jar thoroughly.

If mixture forms precipitates (flakes or sludge), gels, balls up or forms oily films or layers, this indicates incompatibility.  Though signs of incompatibility will typically be seen within 5 minutes of mixing, mixture should be observed for approximately 30 minutes.

Compatibility agents can be used to facilitate mixing.  Add (1/4) teaspoon of the compatibility agent to the mix (assuming a mixing rate of 2 pints compatibility agent per 100 gallons spray mix). If compatibility agents to do not facilitate mixing, the mixture is incompatible and should not be used.

SPRAY EQUIPMENT CLEAN OUT:

After spraying Tolpyralate 400SC and before using sprayer equipment for any other applications, the sprayer must be thoroughly cleaned using the following procedure.

 Drain tank; thoroughly rinse inside of spray tanks with clean water (rinse about 1 minute per 25 gallons of tank capacity).  Loosen and physically remove any visible deposits with a stiff brush.
 Fill the tank with clean water and add 1 gallon of household ammonia (contains at least 3% active ingredient) for every 100 gallons of water.  Circulate the cleaning solution through the tank and hoses for at least 15 minutes.  Flush the cleaning solution through the hoses, boom and nozzles (1/4 volume of tank capacity) and then drain the tank.
 Repeat step 1.
 Repeat step 2.
 Remove the nozzles and screen and clean separately in a bucket containing cleaning agent and water.
 Rinse the tank, boom and hoses with clean water.
 If only ammonia is used as a cleaner, the rinsate solution from both steps 2 and 4 may be applied back to the crop(s) as specified on the label.  Do not exceed the maximum label use rate.  If other cleaners are used, consult the cleaner label for rinsate disposal instructions.  If no instructions are given, dispose of the rinsate on site or at an approved waste disposal facility.
   (Attention: Do Not use Chlorine bleach with ammonia as a dangerous gas will form).

APPLICATION INFORMATION

Many crops are highly sensitive to Tolpyralate 400SC. All direct or indirect contact (such as spray drift) with crops other than corn must be avoided (see also SPRAY DRIFT MANAGEMENT).

Sprayer Preparation
Apply Tolpyralate 400SC with spray equipment that has been cleaned and is free of pesticide deposits from previous pesticide use. Clean spray equipment according to manufacturer's directions, see previous pesticide label for appropriate cleanup directions.

For all application systems, use 50-mesh or larger strainer screens.

Postemergence Weed Control
Tolpyralate 400SC is to be applied by ground application only.

Applications for postemergence weed control should be made in 15 to 50 gallons of water per acre.  Use the higher water volumes if vegetation or crop residue is present. Best results are obtained when weeds are small and actively growing.  Broadleaf weeds should be no larger than 5 inches and grasses should be no taller than 5 inches and prior to first tillering. Good coverage is essential to achieve optimum weed control. Higher spray volumes should be used under heavy weed populations or under adverse growing conditions.

Broadcast:  Apply Tolpyralate 400SC using conventional low-pressure ground spray equipment. Follow manufacture's recommendation for spraying pressure and boom height.  Check spray equipment daily for proper maintenance and calibration.

Banded: Tolpyralate 400SC can also be applied as a banded treatment.  Banded rate and volume per treated area can be calculated by multiplying broadcast rate and volume per treated acre by the band width in inches divided by the row width in inches.

Shielded Sprayers:  Shielding the boom or individual nozzles can reduce the effects of wind. However, it is the responsibility of the applicator to verify that the shields are preventing drift and not interfering with uniform deposition of the product.

USE RESTRICTIONS

DO NOT apply this product by air or through any type of irrigation system.
DO NOT apply more than two applications of Tolpyralate 400SC to corn per year. Do not apply more than a total of 0.07 lb. ai/acre/year
Allow at least 14 days between applications of Tolpyralate 400SC.

DO NOT apply Tolpyralate 400SC within 85 days of field corn and popcorn grain harvest.
DO NOT apply Tolpyralate 400SC within 35 days of fresh market sweet corn harvest.
DO NOT graze or feed treated corn forage or silage for 21 days after application of Tolpyralate 400SC.

FIELD CORN, SWEET CORN, AND POPCORN
Tolpyralate 400SC may be used in the production of field corn, sweet corn and popcorn. Tolpyralate 400SC may be applied as a broadcast spray on corn up to 20" tall or that is exhibiting up to and including 6 leaf collars (V6), whichever is more restrictive. While Tolpyralate 400SC has a wide application window in terms of crop safety, research has shown best results are obtained when applications are made early postemergence when corn and weeds are small.  Target applications to corn that is less than 12" tall for improved coverage and best overall performance.

FIELD CORN GROWN FOR SEED
Not all seed corn inbreds have been tested, nor does ISK Biosciences have access to all seed company data. Consequently, ISK Biosciences is not responsible for any crop injury arising from the use of Tolpyralate 400SC on field corn grown for seed. When tank mixing, check the tank mix partner label for instructions for use.

Timing to Weeds
Apply Tolpyralate 400SC when susceptible weeds are young and actively growing, but before they exceed the sizes indicated in Table 1. Treat heavy infestations of weeds before they become too competitive with the crop, especially where soil moisture and/or fertility are limited. Tolpyralate 400SC provides weed control via foliar absorption. Tolpyralate 400SC has limited pre-emergence activity. For later-emerging weeds, a second application or a timely cultivation is required. Applications made to weeds larger than the size indicated on this label or to weeds under stress may result in unsatisfactory control.

Rate
Optimum control of the weeds listed can be achieved with 1.0-1.35 fl oz of Tolpyralate 400SC per acre. Use of higher rates for heavier infestations is recommended.

WEEDS CONTROLLED

When applied as directed, Tolpyralate 400SC will control or partially control the weeds listed in tables 1 and 2.

Table 1. Broadleaf weeds controlled or suppressed with 1.0 to 1.35 fl oz per acre Tolpyralate 400SC

                                  Tolpyralate
                          Tolpyralate
 + Atrazine[1]

                         1.0 to 1.35 fl oz per acre[2]
                                Broadleaf Weeds
                                  Common name

                                Scientific Name
                        Apply to weeds < 5 inch tall
Amaranth, Palmer
Amaranthus palmeri
                                       C
                                       C
Amaranth, Powell
Amaranthus powellii
                                       C
                                       C
Buffalobur
Solanum rostratium
                                       C
                                       C
Carpetweed
Mollugo verticillata
                                       C
                                       C
Cocklebur, common
Xanthium strumarium
                                      PC
                                       C
Dandelion
Taraxacum officinale
                                      NC
                                      PC
Henbit
Lamium amplexicaule
                                       C
                                       C
Kochia
Kochia scoparia
                                      PC
                                       C
Lambsquarters, common
Chenopodium album
                                       C
                                       C
Mallow, Venice
Hibiscus trionum
                                      NC
                                      PC
Marestail/Horseweed
Conyza canadensis
                                      PC
                                      PC
Morningglory, ivyleaf
Ipomoea hederacea
                                      PC
                                      PC
Morningglory, tall
Ipomoea purpurea
                                      PC
                                      PC
Mustard, blue
Chorispora tenella
                                       C
                                       C
Nightshade, black
Solanum nigrum
                                      PC
                                       C
Nightshade, eastern black
Solanum ptychanthum
                                      PC
                                      PC
Nightshade, hairy
Solanum physalifolium
                                       C
                                       C
Pigweed, redroot
Amaranthus retroflexus
                                       C
                                       C
Pigweed, smooth
Amaranthus hybridus
                                       C
                                       C
Ragweed, common
Ambrosia artemisiifolia
                                       C
                                       C
Ragweed, giant
Ambrosia trifida
                                       C
                                       C
Sowthistle, annual
Sonchus oleraceus
                                       C
                                       C
Smartweed, Pennsylvania
Polygonum pensylvanicum
                                      PC
                                      PC
Sunflower, Volunteer
Helianthus annuus
                                       C
                                       C
Sunflower, Wild (Common)
Helianthus annuus
                                       C
                                       C
Thistle, Canada
Circium arvense
                                      PC
                                      PC
Velvetleaf
Abutilon theophrasti
                                       C
                                       C
Waterhemp, common
Amaranthus rudis
                                       C
                                       C
Waterhemp, tall
Amaranthus tuberculatus
                                       C
                                       C
C = Control	PC = Partial control
[1]Use a minimum of 0.5 lb ai per acre atrazine.
[2]Apply 1.35 fl oz per acre for heavy weed pressure.

Table 2. Grasses controlled or suppressed with 1.0 to 1.35 fl oz per acre Tolpyralate 400 SC

                                  Tolpyralate
                          Tolpyralate
 + Atrazine[1]

                         1.0 to 1.35 fl oz per acre[2]
                                    Grasses
                                  Common name

                                Scientific Name
             Apply to grasses < 5 inch tall or before tillering
Barnyardgrass
Echinochloa crus-galli
                                      PC
                                     C[3]
Crabgrass, large
Digitaria sanguinalis
                                       C
                                       C
Foxtail, giant
Setaria faberi
                                       C
                                       C
Foxtail, green
Setaria viridis
                                       C
                                       C
Foxtail, yellow
Setaria pumila
                                       C
                                       C
Goosegrass
Eleusine indica
                                      PC
                                       C
Millet, wild proso
Panicum miliaceum
                                      PC
                                       C
Shattercane / vol. sorghum
Sorghum bicolor
                                      PC
                                     C[3]
Signalgrass, broadleaf
Urochloa platyphylla
                                      NC
                                      PC
C = Control	PC = Partial control	NC = Not controlled
[1]Use a minimum of 0.5 lb ai per acre atrazine.
[2]Apply 1.35 fl oz per acre if under heavy weed pressure
[3]Apply 1.35 fl oz per acre for control of these species.

SPRAY ADDITIVES
To increase efficacy it is highly recommended to use an adjuvant when applying this product. For specific adjuvant and nitrogen fertilizer recommendations with tank mixes see the Tank Mix section of this label.

Adjuvant Selection
The use of MSO (methylated seed oil) is recommended with Tolpyralate.  The use of COC or NIS will also improve performance of Tolpyralate but have been shown to be less effective than MSO.

Methylated Seed Oil (MSO)
 Apply at 0.5 to 1 gal per 100 gal (0.5 to 1% v/v) of spray solution.
 MSO adjuvants may be used at 0.5% v/v (0.5 gal per 100 gal spray solution) if specifically noted on adjuvant product labeling.
 Oil adjuvants must contain at least 80% high quality, petroleum (mineral) or modified vegetable seed oil with at least 15% surfactant emulsifiers.
 An alternative to traditional MSO adjuvants, High Surfactant Oil Concentrates (HSOC) at recommended rates may be used with Tolpyralate. An HSOC is an emulsifiable oil based product containing 25 to 50% surfactant and a minimum of 50% oil.

Nonionic Surfactant (NIS) or Crop oil Concentrate (COC)
 Apply NIS at 1 qt per 100 gal spray solution (0.25% v/v) or 0.5% under arid conditions.
 Surfactant products must contain at least 60% nonionic surfactant with a hydrophilic/lipophilic balance (HLB) greater than 12.
      Apply COC at 1.0 gal per 100 gal (1%) spray solution.

Ammonium Nitrogen Fertilizer
 Use 2.5 gal per 100 gal (2.5% V/V) spray solution of a high-quality urea ammonium nitrate (UAN), such as 28% N or 32% N, or 8.5 lb per 100 gal of a spray grade ammonium sulfate (AMS).
 Do not use liquid nitrogen fertilizer as the total carrier solution.

Special Adjuvant Types
 Combination adjuvant products may be used at doses that provide the required amount of NIS, COC, MSO and/or ammonium nitrogen fertilizer. Consult product literature for use rates and restrictions.
 In addition to the adjuvants specified above, other adjuvant types may be used if they provide the same functionality and have been evaluated.

TANK MIX APPLICATIONS

Tolpyralate 400SC may be tank mixed with many herbicides registered for postemergence application in corn for additional control of broadleaf and grass weeds. See the tank mix partner label for weeds controlled, precautions, use restrictions, adjuvant and crop rotation information. The most restrictive language on either label shall apply.

Check with the manufacturer for information on tank mix compatibility prior to using (see TANK MIX COMPATIBILITY TESTING).

ADDITIONAL DIRECTIONS AND/OR DIRECTIONS FOR SPECIFIC WEED PROBLEMS TANK MIXTURES WITH ATRAZINE
Tank mixtures with atrazine are recommended for additional burndown effect and for limited pre-emergence activity. Unless restricted, Tolpyralate 400SC may be tank mixed with 0.5 to 2.0 lb ai atrazine per acre.

ROTATIONAL CROP INFORMATION

The following crop rotational crops may be planted after applying Tolpyralate 400SC at the labeled application rates in corn as shown table. If Tolpyralate is tank mixed with other products, follow the most restrictive crop's rotation interval.

Table 3. Time interval between Tolpyralate 400SC and replanting or planting of rotational Crops
                                     Crop
                          Replant/Rotational interval
Corn, sweet corn, and popcorn
                                   Immediate
Wheat
Barley
Oats
Rye
Grass, grown for seed or forage

                                   3 months
Alfalfa
Bean, dry
Bean, green (including seed production)
Cabbage
Canola, rapeseed
Cotton
Peas, field and edible
Peanut
Potato
Rice
Snap beans
Sorghum
Soybean
Cucurbits
Sunflower
Tomato

                                   9 months
Sugar beets
                                   18 months
All other rotational crops

                                   12 months

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STORAGE AND DISPOSAL
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Pesticide Storage: Store product in original container only. Do not contaminate water, other pesticides, fertilizer, food or feed in storage. Store in a cool, dry place.
--------------------------------------------------------------------------------
Pesticide Disposal: Do not contaminate water, food, or feed by disposal. Waste resulting from the use of this product may be disposed of on site or at an approved waste disposal facility.
--------------------------------------------------------------------------------
Container Handling: Non-refillable container. DO NOT reuse or refill this container.  Triple rinse container (or equivalent) promptly after emptying.  Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip.  Fill the container (1/4) full with water and recap.  Shake for 10 seconds.  Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal.  Drain for 10 seconds after the flow begins to drip.  Repeat this procedure two more times.  Then offer for recycling if available, or puncture and dispose of in a sanitary landfill, or by incineration or, if allowed by state and local authorities, by burning.  If burned, stay out of smoke.

LIMITATION OF WARRANTY AND LIMITATION OF DAMAGES

Seller warrants to those persons lawfully acquiring title to this product that at the time of first sale of this product by Seller that this product conformed to its chemical description and was reasonably fit for the express purposes stated on the label when used in accordance with Seller's directions under normal conditions of use as described on the label. To the extent consistent with applicable law, Buyers and users of this product assume the risk of any use contrary to such directions.  TO THE FULLEST EXTENT PERMITTED BY LAW, EXCEPT AS PROVIDED ELSEWHERE IN WRITING CONTAINING AN EXPRESS REFERENCE TO THIS LIMITATION OF WARRANTY AND LIMITATION OF DAMAGES, SELLER MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY OR GUARANTY, AND SELLER EXPRESSLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTIBILITY OR OF FITNESS FOR A PARTICULAR PURPOSE AND EXPRESSLY DISCLAIMS ALL OTHER EXPRESS OR IMPLIED WARRANTIES THAT MAY EXIST UNDER APPLICABLE LAW, COURSE OF DEALING OR USAGE OF TRADE.  NO AGENT OF SELLER IS AUTHORIZED TO GRANT ANY WARRANTY IN EXCESS OF THAT GRANTED IN THIS LIMITATION OF WARRANTY AND LIMITATION OF DAMAGES.  TO THE FULLEST EXTENT PERMITTED BY LAW, IN NO EVENT SHALL SELLER BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES RESULTING FROM THE HANDLING OR USE OF THIS PRODUCT.  TO THE FULLEST EXTENT PERMITTED BY LAW, SELLER'S LIABILITY FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE HANDLING OR USE OF THIS PRODUCT SHALL NOT EXCEED THE PURCHASE PRICE OF THE PRODUCT AS TO WHICH A CLAIM IS MADE. To the fullest extent permitted by law, Buyers and users of this product are responsible for all loss or damage from use or handling of this product that results from conditions beyond the control of Seller, including, but not limited to, incompatibility with other products (unless otherwise expressly provided for in the Directions for Use of this product), weather conditions, cultural practices, moisture conditions or other environmental conditions outside of the ranges that are generally recognized as being conducive to good agricultural and/or horticultural practices.


[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Pages 19956-19957]
[FR Doc No: E9-10004]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0401; FRL-8409-5]

Pesticide Product Registrations; Conditional Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces Agency approval of applications
submitted by Syngenta Seeds, Incorporated - Field Crops - NAFTA, to
conditionally register the pesticide products, MIR162 Maize, Bt11 x
MIR162 Corn, and Bt11 x MIR162 x MIR604 Corn, containing a new active
ingredient not included in any previously registered products pursuant
to the provisions of section 3(c)(7)(C) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2008-0401. 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>.
    In accordance with section 3(c)(2) of FIFRA, a copy of the approved
label, the list of data references, the data and other scientific
information used to support registration, except for material
specifically protected by section 10 of FIFRA, are also available for
public inspection. Requests for data must be made in accordance with
the provisions of the Freedom of Information Act and must be addressed
to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave.,
NW., Washington, DC 20460-0001. Such requests should: Identify the
product name and registration number and specify the data or
information desired.
    Electronic versions of the fact sheet and Biopesticide Regulatory
Action Document are available at http://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Did EPA Conditionally Approve the Application?

    A conditional registration may be granted under section 3(c)(7)(C)
of FIFRA for a new active ingredient where certain data are lacking, on
condition that such data are received by the end of the conditional
registration period and do not meet or exceed the risk criteria set
forth in 40 CFR 154.7; that use of the pesticide during the conditional
registration period will not cause unreasonable adverse effects; and
that use of the pesticide is in the public interest. The Agency has
considered the available data on the risks associated with the proposed
use of Bacillus thuringiensis Vip3Aa20 insecticidal protein and the
genetic material for its production (via elements of vector pNOV1300)
in Event MIR162 maize (OECD Unique Identifier SYN-IR162-4), and
information on social, economic, and environmental benefits to be
derived from such use. Specifically, the Agency has considered the
nature and its pattern of use, application methods and rates, and level
and extent of potential exposure. Based on these reviews, the Agency
was able to make basic health and safety determinations which show that
use of Bacillus thuringiensis Vip3Aa20 insecticidal protein and the
genetic material for its production (via elements of vector pNOV1300)
in Event MIR162 maize (OECD Unique Identifier SYN-IR162-4) during the
period of conditional registration will not cause any unreasonable
adverse effect on the environment, and that use of the pesticide is, in
the public interest.
    Consistent with section 3(c)(7)(C) of FIFRA, the Agency has
determined that these conditional registrations are in the public
interest. Use of the pesticides are of significance to the user
community, and appropriate labeling, use directions, and other measures
have been taken to ensure that use of the pesticides will not result in
unreasonable adverse effects to man and the environment.

III. Conditional Approval

    EPA issued a notice, published in the Federal Register of July 23,
2008 (73 FR 42799) (FRL-8365-4), which announced that Syngenta Seeds,
Incorporated - Field Crops - NAFTA, P.O. Box 12257, 3054 Cornwallis
Road, Research Triangle Park, NC 27709-2257, had submitted applications
to conditionally register the pesticide products, MIR162 Maize, Bt11 x
MIR162 Corn, and Bt11 x MIR162 x MIR604 Corn, Plant-

Incorporated Protectants (EPA File Symbols 67979-RU, 67979-RE, and
67979-RG) respectively, containing Bacillus thuringiensis Vip3Aa20
insecticidal protein and the genetic material for its production (via
elements of vector pNOV1300) in Event MIR162 maize (OECD Unique
Identifier SYN-IR162-4), an active ingredient not included in any
previously registered product.
    The applications were conditionally approved on November 26, 2008,
as MIR162 Maize (EPA Registration Number 67979-14), on February 13,
2009, as Bt11 x MIR162 Corn (EPA Registration Number 67979-12), and as
Bt11 x MIR162 x MIR604 Corn (EPA Registration Number 67979-13). These
products are plant-incorporated protectants for use on corn.

List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: April 17, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E9-10004 Filed 4-29-09; 8:45 am]
BILLING CODE 6560-50-S