[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Proposed Rules]
[Pages 73393-73394]
[FR Doc No: 2012-29698]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1085]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule; correction.

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SUMMARY: On February 5, 2010, FEMA published in the Federal Register a
proposed rule that contained an erroneous table. This notice provides
corrections to that table, to be used in lieu of the information
published at 75 FR 5909. The table provided here represents the
flooding source, location of referenced elevations, effective and
modified elevations, and community affected for Ballard County,
Kentucky, and Incorporated Areas. Specifically, it addresses the
following flooding sources: Cane Creek (backwater effects from
Mississippi, Hazel Creek (backwater effects from Ohio River), Humphrey
Creek (backwater effects from Ohio River), Humphrey Creek Tributary 9
(backwater effects from Ohio River), Lucy Creek (backwater effects from
Ohio River), Mississippi River, Ohio River, and Stovall Creek
(backwater effects from Mississippi River.

DATES: Comments are to be submitted on or before March 11, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1085, to Luis Rodriguez, Chief, Engineering Management Branch, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER> or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) publishes proposed determinations of Base (1% annual-chance)
Flood Elevations (BFEs) and modified BFEs for communities participating
in the National Flood Insurance Program (NFIP), in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are minimum requirements.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities. These proposed elevations are
used to meet the floodplain management requirements of the NFIP and
also are used to calculate the appropriate flood insurance premium
rates for new buildings built after these elevations are made final,
and for the contents in those buildings.

Corrections

    In the proposed rule published at 75 FR 5909, in the February 5,
2010, issue of the Federal Register, FEMA published a table under the
authority of 44 CFR 67.4. The table, entitled ``Ballard County,
Kentucky, and Incorporated Areas'' addressed the following flooding
sources: Cane Creek (backwater effects from Mississippi, Hazel Creek
(backwater effects from Ohio River), Humphrey Creek (backwater effects
from Ohio River), Humphrey Creek Tributary 9 (backwater effects from
Ohio River), Lucy Creek (backwater effects from Ohio River),
Mississippi River, Ohio River, and Stovall Creek (backwater effects
from Mississippi River. That table contained inaccurate information as
to the communities affected for the flooding source the Mississippi
River. In this notice, FEMA is publishing a table containing the
accurate information, to address these prior errors. The information
provided below should be used in lieu of that previously published.

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                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                 feet  (NAVD)  Depth in feet above
         Flooding source(s)            Location of referenced       ground  [caret]        Communities affected
                                            elevation **          Elevation in meters
                                                                         (MSL)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                 Ballard County, Kentucky and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Cane Creek (backwater effects from    From the confluence             +331         +330  Unincorporated Areas of
 Mississippi River).                   with Shawnee Creek                                 Ballard County.
                                       Slough to
                                       approximately 2.3
                                       miles upstream of
                                       confluence with
                                       Shawnee Creek Slough.
Hazel Creek (backwater effects from   From the confluence             +332         +331  Unincorporated Areas of
 Ohio River).                          with Brushy Pond Creek                             Ballard County.
                                       to approximately 3.2
                                       miles upstream of the
                                       confluence with Brushy
                                       Pond Creek.

Humphrey Creek (backwater effects     From the confluence             +332         +331  Unincorporated Areas of
 from Ohio River.                      with Lucy Creek to                                 Ballard County.
                                       approximately 2,007
                                       feet upstream of the
                                       confluence with Lucy
                                       Creek.
Humphrey Creek Tributary 9            From the confluence             +332         +331  Unincorporated Areas of
 (backwater effects from Ohio River).  with Humphrey Creek to                             Ballard County.
                                       approximately 1,320
                                       feet upstream of the
                                       confluence with
                                       Humphrey Creek.
Lucy Creek (backwater effects from    From the confluence             +332         +331  Unincorporated Areas of
 Ohio River).                          with Humphrey Creek to                             Ballard County.
                                       approximately 0.45
                                       mile upstream of the
                                       confluence with
                                       Humphrey Creek.
Mississippi River...................  Approximately 3.5 miles         +330         +329  City of Wickliffe,
                                       downstream of the                                  Unincorporated Areas
                                       confluence with the                                of Ballard County.
                                       Ohio River.
                                      Approximately 0.5 mile          +331         +330
                                       upstream of the
                                       confluence with the
                                       Ohio River.
Ohio River..........................  Approximately 3.0 miles         +331         +330  Unincorporated Areas of
                                       upstream of the                                    Ballard County.
                                       confluence with the
                                       Mississippi River.
                                      Approximately 6.3 miles         +335         +334
                                       upstream of Lock and
                                       Dam 53.
Stovall Creek (backwater effects      From the confluence             +330         +329  Unincorporated Areas of
 from Mississippi River).              with the Mississippi                               Ballard County.
                                       River to approximately
                                       1 mile upstream of
                                       Mayfield Road.
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* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472.

                                                    ADDRESSES

City of Wickliffe
Maps are available for inspection at 321 Court Street, Wickliffe, KY 42087.

                                     Unincorporated Areas of Ballard County

Maps are available for inspection at 134 North 4th Street, Wickliffe, KY 42087.
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(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 8, 2012.
James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2012-29698 Filed 12-7-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69556-69557]
[FR Doc No: 2014-27582]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0106; Notice 1]

Oreion Motors, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: Oreion Motors, LLC (Oreion) has determined that certain 2011-
2013 Oreion Reeper low speed vehicles, do not fully comply with
paragraph S5.(b)(10) of Federal Motor Vehicle Safety Standard (FMVSS)
No. 500 which requires installation of seat belts that conform to FMVSS
No. 209, Seat Belt Assemblies. Oreion has filed an appropriate report
dated August 13, 2014, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports.

DATES: The closing date for comments on the petition is December 22,
2014.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: 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 Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: Logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:
    I. Oreion's Petition: Pursuant to 49 U.S.C. 30118(d) and 30120(h)
(see implementing rule at 49 CFR part 556), Oreion submitted a petition
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety.
    This notice of receipt of Oreion's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Low Speed Vehicles Involved: Affected are approximately 526
2011-2013 Oreion Reeper low speed vehicles originally manufactured with
seatbelts manufactured by Changzhou Dongchen.
    III. Noncompliance: Oreion explains that the noncompliance is that
the seatbelts installed in the subject vehicles do not fully comply
with the requirements of paragraph S5.(b)(10) of FMVSS No. 500 because
the year that the seatbelts were manufactured is not included on the
seatbelts as specified in paragraph S4.1(j) of FMVSS No. 209.
    V. Rule Text: Paragraph S5.(b) of FMVSS No. 500 requires in
pertinent part:

    (b) Each low-speed vehicle shall be equipped with: . . . (10) A
Type 1 or Type 2 seat belt assembly conforming to Sec. 571.209 of
this part, Federal Motor Vehicle Safety Standard No. 209, Seat belt
assemblies, installed at each designated seating position.

Paragraph S4.1(j) of FMVSS No. 209 requires in pertinent part:

    S4.1(j) Marking. Each seat belt assembly shall be permanently
and legibly marked or labeled with year of manufacture . . .

    V. Summary of Oreion's Analyses: Oreion believes that the subject
noncompliance is inconsequential to motor vehicle safety because they
believe that the lack of the year of manufacture on the seat belts has
no effect on the operational safety of the seat belts installed in the
subject noncompliant vehicles.
    Oreion stated its belief that the seat belts in the subject
vehicles have functioned as deigned during normal use. They contend
that this is supported by their observation that no vehicle owner has
brought their vehicle back to a dealership for seat belt related
repairs.
    Oreion stated its awareness that the year date stamp may be used
with the seat belt model number to identify seat belt assemblies
recalled by the seat belt manufacturer. In the event of a safety
related recall by the seat belt manufacturer, Oreion will cooperate
with the seat belt manufacturer to identify the vehicle owners of the
vehicles containing affected seat belts without the need for the year
stamp on the label. Oreion believes that the model number and the build
date of the vehicle will be sufficient to accomplish this task.
    In summation, Oreion believes that the described noncompliance of
the subject low speed vehicle's seat belt assemblies is inconsequential
to motor vehicle safety, and that its petition, to exempt Oreion from
providing recall notification of noncompliance as required by 49 U.S.C.
30118 and remedying the recall noncompliance as required by 49 U.S.C.
30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allows NHTSA to exempt
manufacturers only from the duties found in sections 30118 and 30120,
respectively, to notify owners, purchasers, and dealers of a defect or

noncompliance and to remedy the defect or noncompliance. Therefore, any
decision on this petition only applies to the subject low speed
vehicles that Oreion no longer controlled at the time it determined
that the noncompliance existed. However, any decision on this petition
does not relieve vehicle distributors and dealers of the prohibitions
on the sale, offer for sale, or introduction or delivery for
introduction into interstate commerce of the noncompliant low speed
vehicles under their control after Oreion notified them that the
subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2014-27582 Filed 11-20-14; 8:45 am]
BILLING CODE 4910-59-P


United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-001
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.6100:

Environmental Chemistry Methods and Associated Independent Laboratory Validation

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  NOTICE
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  This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).  To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number.  Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in their title.
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  	The OCSPP harmonized test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice.  At places in this guidance, the Agency uses the word "should."  In this guidance, the use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.
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  	For additional information about these test guidelines and to access these guidelines electronically, please go to http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.
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OCSPP 850.6100: Environmental chemistry methods and associated independent laboratory validation.
(a) Scope --
      (1) Applicability. This guideline is intended to be used to help develop data to submit to EPA under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).
 	(2) [Reserved]
(b) Purpose.  This guideline is intended to provide guidance on demonstrating the performance of environmental chemistry methods (ECMs) used in field dissipation and ground water monitoring studies under the OCSPP 835 Environmental Fate Test Guidelines, or used in field studies of terrestrial and aquatic organisms and plants under the OCSPP 850 Ecological Effects Test Guidelines.  In addition guidance is provided on the conduct and performance of an ECM's associated independent laboratory validation (ILV).  When reporting an ECM and its performance to the Agency in support of study results, registrants are required under 40 CFR Part 158 to provide to the Agency an ILV of the ECM(s) used to generate the laboratory and/or field residue data.  An ILV is a part of a process to verify that a submitted ECM is suitable for its intended purpose and will be able to generate laboratory and/or field residue data when used routinely that are accurate and precise at the set reportable residue range.  This includes all single or multianalyte methods for identification and quantification of the parent compound, toxicologically significant metabolites and degradates in each environmental matrix sampled in the specific guideline study.
(c) General considerations.
      (1) Registrant(s) provide to the Agency a report of a finalized ECM with appropriate revisions or changes recommended by an independent laboratory based on their ILV along with the laboratory or field residue study results.
      (2) Registrants need to use an independent laboratory to validate the environmental chemistry methods used to generate laboratory and/or field residue data.  If that laboratory is located in the registrant's organization, or is in anyway associated with the development of the original ECM, the same people, equipment, instruments, and supplies (i.e., glassware, solvents, reagents, standard reference materials, etc.) should not be utilized to validate the ECM.  The Agency does not expect the registrant to synthesize or purchase another lot of authentic analytical grade standard but it does expect the independent laboratory would need to use a new aliquot of that standard to prepare spiking solutions for the ILV in order for the results to be meaningful.
      (3) If the methods to be used to generate study data use conventional gas chromatography (GC), liquid chromatography (LC), etc., confirmatory methods include using a mass spectrometer (MS) in conjunction with the method (e.g., GC/MS, LC/MS) or a second column or other suitable procedures.  It is not necessary typically to perform another confirmatory procedure where GC/MS and LC/MS methods are used as the primary method(s) to generate study data.
      (4) Regulatory chemists should be able to validate practical and rapid analytical methods using a set of samples in twenty-four hours (e.g., three eight-hour working days); however, the Agency recognizes that methods may require additional time.
      (5) Performance data submitted to the Agency should demonstrate that an adequate number of samples for each test level were extracted, cleaned up, and analyzed.  Each set should have an appropriate number of samples with quality control samples intermingled.  This data should support the limit of detection (LOD) or the method detection limit (MDL), the established limit of quantitation (LOQ), and the precision and accuracy for each ECM.
(d) Environmental chemistry method --
      (1) Method Details.
            (i) The ECM should be clearly written with complete analytical methods that describe the exact procedure, materials, and equipment in sufficient detail to be used by laboratory chemists to review the ECM and its associated ILV results.  All environmental chemistry methods should be stamped non-confidential.
            (ii) Analytical environmental chemistry methods used should be practical, and be able to quantitate analytes in the study matrix (or matrices) at the data quality objective(s) set for the laboratory or field residue study.  Equipment used to perform the method(s) should be commercially available in the United States.
            (iii) The analytical methods should meet acceptable performance objectives described in paragraph (d)(2) of this guideline.
            (iv)  During the Agency evaluation of an ECM or ECMs, the registrant may be requested to supply to the Agency an active ingredient analytical grade standard and/or toxicologically significant metabolite(s) and degradate(s) to the Agency.  In addition stable derivative(s) that were used to identify and quantitate the target analytes may also be requested to support the evaluation of the ECM and ILV by the Agency.
      (2) Data quality objectives.
            (i)  The mean recovery at each spiking level, at or above the LOQ, should lie between 70 and 120% of the known quantity of the pesticide/metabolite/ degradate spiked into the matrix blanks during the method validation.
            (ii) The relative standard deviation (RSD) of replicate measurements of recoveries should not exceed the target level of plus or minus 20%.
            (iii) The Agency recognizes that some methods may not be able to meet these precision objectives.  The Agency will review the results of those methods to determine their significance on the acceptability of the ECM.  Methods will not be rejected outright for failure to comply with each and every aspect of the data quality objectives but will be reviewed on a case-by-case basis to determine their suitability by science reviewers and chemists in the Agency.
            (iv) For an acceptable ECM, reported sample values should not be corrected for recoveries.
(e) Independent laboratory validation procedures --
      (1) Independent laboratory.
            (i)  Validation of the ECM is conducted by a laboratory operating independently from that of the originator of the method.  The independent laboratory conducting the validation may be privately or publicly owned and under certain conditions may belong to the same organization as the originating laboratory or in the registrant's own organization.
            (ii) The originating and validation laboratories may belong to the same organization, but in order for the validation to be independent the analysts, equipment, instruments, and supplies (e.g., glassware, solvents, reagents, standard reference materials) should be distinct and operate separately and without collusion for the validation.  Furthermore, the personnel conducting the independent validation should not report to the same study director who was involved in developing the original method or who may have used the method to develop data for laboratory field studies to support pesticide registration or reregistration actions.  For the validation to be independent, the laboratory chemists chosen to conduct the ILV would be expected to be unfamiliar with the method both in its development and subsequent use in analyzing samples collected from field studies.  These individuals, however, should be trained and experienced pesticide residue chemists.
            (iii) ILV trials are conducted under FIFRA GLP (40 CFR Part 160).  Alternatively ILV trials conducted under OECD Principles of Good Laboratory Practice are also considered in compliance with FIFRA GLP.
      (2) Test substance.  An aliquot of the test substance used in the method development should be used to prepare spiking solutions for the ILV aliquot of that standard in order to prepare spiking solutions for the ILV.
      (3) Test matrix.
            (i) To assess the ECM, the ILV test includes normal test conditions which include the presence of other compounds expected to be present.  Matrix or matrices (e.g., soil, water, plant or animal tissue) to be sampled as part of the laboratory and/or field study to generate residue data should be identified and/or supplied to the independent lab by the registrant.  Chemists at the independent lab should use these samples to prepare matrix spikes for the validation study.
            (ii) An ILV is conducted for each ECM for a given sample matrix for each parent compound, significant metabolites, and/or degradates.  A method used for more than one study should meet the same performance standards as the original method.  For a given sample matrix, the registrant should select the most difficult analytical sample condition from the study (e.g., high organic content versus low organic content in a soil matrix) to analyze from the study to demonstrate how well the method performs.
            (iii) It is recommended that the registrant or their representative keep a reasonable amount of each solid matrix tested from a site for two years after registration, reregistration, or until the Agency has completed its evaluation of the studies.
      (4) Environmental chemistry methods.
            (i) The ECMs given to the independent laboratory should be the same ones that were used or to be used by the registrant to generate laboratory and/or field study residue data.  For the ILV, the laboratory conducting the ILV uses the methods exactly as they are written by the registrant or its method development laboratory and should only contact the registrant or developer to clarify minor deficiencies in the methods.  For example, if the characteristics of the clean up column were not adequately described in a method, the independent laboratory should contact the registrant or developer for clarification prior to running the first sample set of ILV samples (see paragraph (e)(5)(i)(A) of this guideline).
            (ii) The laboratory conducting the ILV trial may contact the developers or previous users of the method prior to running the first set of samples, but all communications should be logged and reported to the Agency documenting that such communication did not compromise the independent evaluation.  The ILV itself is likely to be invalid if anyone from the petitioner, developer, or any previous users are allowed to visit the laboratory during the ILV trial to observe, offer help, or assist the chemists or technicians.
      (5) ILV.  The independent laboratory establishes the relationship between the instrument responses and concentrations of analytes and verifies that matrix control samples are free of interferences at the appropriate retention time, wavelength or detector setting.  All quality control conditions should be satisfied in order to demonstrate that the method is under control and before the independent laboratory analyzes any performance samples to be reported to the Agency.  Any contact with the registrant or developers during the establishment of the method should be documented in writing in the final report submitted by the independent laboratory.  This should be conducted following FIFRA GLP (40 CFR Part 160) or alternatively conducted following OECD Principles of GLP, which are considered in compliance with FIFRA GLP.
            (i) Performance samples --
                  (A) Sample sets.  A maximum of three sample sets are used by an independent laboratory to validate the method as written.  A complete sample set consists at a minimum of a reagent blank, two unspiked matrix control samples, five matrix control samples spiked at the LOQ and another five matrix control samples spiked at ten times the LOQ (10xLOQ) for each distinct matrix.  A complete set may include more than thirteen samples depending on the number of reagent, unspiked and spiked matrix control samples.  It may be necessary, however, to divide a complete set into two subsets for efficient handling.  Each subset should contain a reagent blank, two unspiked matrix control samples, and five matrix control samples spiked at the LOQ or 10xLOQ.  The independent laboratory will use the predetermined values from the registrant for the LOQ and 10xLOQ to establish appropriate spiking levels.
                  (B) Validation.
                        (1) A successful ILV includes performance data on at least one complete set of samples that meets those data quality objectives described in paragraph (d)(2) of this guideline.
                              (a) Data from matrix control samples (blanks) are not used to correct values from spiked matrix controls for recoveries.
                              (b) Interferences with peak areas that are less than 50 percent (%) at the MDL or LOD, are considered not significant.
                        (2) If the performance data on the first set of samples at any of the spiking levels are unsuccessful, the independent laboratory may contact the registrant or developer to clarify the directions given in the method.  Any contact with the registrant or developers during the method validation should be documented in writing in the final report submitted by the independent laboratory.
                        (3) If the independent laboratory cannot generate performance data that is similar to the registrant's or developer's after running the second sample set, the independent laboratory may contact the registrant, developer, or other users of the method to further clarify the directions given in the method.  All communications should be recorded.
                        (4) If the independent laboratory cannot generate performance data that is similar to the registrant's or developer's after the third set, the method should be failed and a report sent to the registrant explaining why the method failed.  The registrant should then decide whether to repeat the independent laboratory validation at another laboratory, further develop the method, or withdraw it.
                        (5) Any significant changes that are made to the method by the chemists at the independent lab should be incorporated into the original method and reported in writing immediately to the registrant.  If those changes impact the performance of the original method, such as its precision, accuracy or limit of quantitation, the registrant should report those changes to the Agency.  The revised or rewritten method, performance data, chromatograms and computations from all sets and/or subsets are sent to the registrant.  The registrant, with the assistance of the IL, will decide how to present that information to the Agency.
            (ii) ILV report to registrant.  The independent laboratory should prepare a well documented laboratory report and send it to the registrant as the ILV of the ECM and that report with appropriate changes by the registrant is then submitted to the Agency with the laboratory or field study.  The Agency highly recommends that the ILV report follow the format in paragraph (f) of this guideline.
                  (A) The independent laboratory should submit performance data to the registrant demonstrating that an adequate number of samples for each test level were extracted, cleaned up, and analyzed.  Each set should have an appropriate number of spiked matrix control samples with method control and matrix control samples intermingled.
			(B)  Results reported should include:
                        (1) Results of each performance sample set  --  LOD or the MDL, the established LOQ, and accuracy and precision measured.
                        (2) The mean and individual values for recoveries and standard deviations for the pesticide parent, toxicologically significant metabolites and/or degradates in fortified matrix control samples at each spiking level.
                        (3) The confidence intervals (95 or 99%) for the true average recoveries at each spiking level.
				(4) Individual values for recoveries at each spiking level.
                  (C) Any matrix or solvent effects that result in signal enhancement, masking or suppression and the impact those effects have on the test results is described.

(f) Reporting and reporting format.  Information to be supplied in the report for each ECM for a given matrix includes the information items listed in paragraphs (f)(1) through (f)(10) of this guideline.  Paragraphs (f)(1) through (f)(10) are also the recommended reporting format to aid the applicant/registrant in generating reports which are compatible with the Agency's review process.  Recommend for the ILV report that the IL also follow this reporting format, excluding information in paragraph (f)(7)(ix) and with modifications applicable to the IL, for submittal to the registrant.
	(1) Title/cover page.
      (2) Certification.
            (i) For each ECM, the identification of those laboratories that developed the data submitted to the Agency.  For each ECM ILV, the identification of the laboratory that conducted the ILV and a statement that the laboratory was requested to perform the ILV for the registrant.
            (ii) Certification of authenticity by the Study Director and Lead Chemist for the laboratory that developed the method (including signature, typed name, title, affiliation, address, telephone number, and date).
            (iii) Statement of adherence to the FIFRA GLP (40 CFR part 160) or OECD Principles of Good Laboratory Practice, as appropriate.
            (iv) Statement of claims for non-confidentiality and that the method contains no trade secrets or proprietary data.
	(3) Table of contents.
      (4) Summary.  Provide a brief description of paragraphs (f)(6)(ii) and (f)(6)(iii) of this guideline.
	(5) Materials --
      (i) Equipment.  A list and description of equipment used.
            (ii) Reagents and standards.
                  (A) List and describe the source, purity and stability of analytical grade standards.
			(B) Describe the source and preparation of reagents.
		(iii) Safety and Health.
            (A) Provide material safety data sheets (MSDS).
                  (B) Describe any special precautions that need to be taken with standards, solvents or reagents and any procedural steps that require special precautions to avoid safety or health hazards.
	(6) Methods.
      (i) Principles of the analytical methods.
            (ii) Analytical procedures.  Describe the analytical procedure(s) for an environmental matrix in a detailed step wise fashion:
                  (A) Sample matrix.  Identify the source of the sample and characterize the sample matrix.  For example, characterization of a soil sample might include a description of its textural class and percent organic matter, and characterization of a water sample might include pH, turbidity, specific conductance, etc.
			(B) Preparation of samples.
                  (C) Extraction.  Demonstrate efficiency in specific soil samples from field sites.
                  (D) Fortifications.  Describe fortifications used during method validation runs.
			(E) Clean-up.
			(F) Derivization (if any).
            (iii) Instrumentation.
                  (A) Description of the instruction including make and model, type and specificity of detector(s), column(s) (packing materials, size), carrier gas(es), etc.
                  (B) Operating conditions of the instruments including flow rate(s), temperature(s), voltage, etc.
			(C) Calibration procedures (frequency and stability).
            (iv) Potential interference(s).  Describe the effects of the following on signal enhancement, masking or suppression of signal and their impact on the test results:
			(A) Sample matrices.
			(B) The use of other pesticides on the test site.
			(C) Solvents.
			(D) Labware.
            (v) Confirmatory techniques.  Describe confirmatory techniques (i.e., GC/MS, LC/MS, second column, etc.)
            (vi) Time required for analysis.  Give the time required to take one sample set completely through the analytical procedure, including sample preparation, extraction, cleanup, derivatization, and determination steps.  Identify those steps that could significantly increase the time required to complete the method.
            (vii) Modifications or potential problems.  Specify any allowable variances and describe any unique steps where little variation is allowed in the method.  Describe any potential problems and/or modifications that were made to the analytical procedures.
            (viii) Methods of calculation.  Describe calculations in a step wise fashion for a specific individually spiked matrix control sample at the LOQ which would include the raw data of the analysis, calibration factors, calibration curves with the raw data of all of the standards used to generate the curve for the parent compound, metabolites, and degradates, etc. with the calculations used to generate the final concentration and recovery of the spiked matrix control sample.
            (ix) Copies of chromatograms/spectra.  Representative sample chromatograms/spectra should be submitted for each analyte measured in each matrix at all spiking levels, including method and matrix blanks.  In addition, chromatograms/spectra with the highest levels of background and poorest resolution and copies of the chromatograms/spectra for the standards used to quantitate the analyte(s) in the representative matrix are submitted in the report to the Agency.  Also recommend submitting a set of representative sequential chromatograms.  Analyte peaks of interest should be correctly labeled to show appropriate retention times, peak areas, and heights on each chromatogram.
            (x) Other.  Describe any and all additional information the registrant considers appropriate and relevant to provide a complete and thorough description of the soil and water method.
	(7) Results/Discussion.
      (i) Method validation results (include tables of test levels and results of analysis).
	(ii) Accuracy (mean, range of recoveries, standard deviations and confidence limits for specific concentration levels, such as the LOQ or 10xLOQ).
	(iii)) Precision.  Provide the RSD at each specific concentration level.
	(iv) Limit of detection.  Provide a clearly written explanation of how this value is calculated and cite the reference.
	(v) Limit of quantitation.  Provide a clearly written explanation of how this value is calculated and cite the reference.
	(vi) Ruggedness testing (if performed).
	(vii) Discussion of selectivity and specificity of method.
	(viii) Limitations.
	(ix) Interference/calibration.
	(x) Independent laboratory validation.
      (8) Conclusion.  Discuss applicability of the ECM for measuring specific test compound(s) in the study matrix or various matrices, ranges, expected recoveries, interference(s), etc.
	(9) Tables/Figures.
	(10) References.
(g) References.  The following reference should be consulted for additional background material on this test guideline.
      (1) Organization for Economic Cooperation and Development, 1998.  Series on Principles of Good Laboratory Practice and Compliance Monitoring No. 1 OECD Principles of Good Laboratory Practice, ENV/MC/CHEMC(98)17, Revised in 1997.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  27 October 2009

SUBJECT:	Clopyralid – Petition for Tolerances on Swiss chard,
Bushberry Subgroup 13-07B, and Strawberry (Regional Restriction).
Summary of Analytical Chemistry and Residue Data.

PC Code:  117401 (alkanolamine salts), 117403 (acid)	DP Barcode:
D361787

Decision No.:  403248	Registration Nos.:  62719-80, 62719-81, and
62719-84

Petition No.:  8E7481	Regulatory Action:  Section 3 and 24(c)
Registrations

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS Nos.:	1702-17-6 (acid)

	57754-85-5 (monoethanolamine salt)

MRID No.:  See MRID Summary Table	40 CFR:  180.431

FROM:	Michael A. Doherty, Ph.D., Chemist  SEQ CHAPTER \h \r 1

		Risk Assessment Branch II

		Health Effects Division (7509P)

THROUGH:	William Drew, Chemist

		Risk Assessment Branch II

		Health Effects Division (7509P)

TO:		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Barbara Madden, RM 05

		Risk Integration, Minor Use & Emergency Response Branch

		Registration Division (7505P)

MRID Summary Table

MRID No.	Study Type	Comments

47604401	860.1500 Swiss chard	New DER 47604401.der

47604402	860.1500 blueberry	New DER 47604402.der

47604403	860.1500 strawberry	New DER 47604403.der

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation (1910 Sedwick Road, Building 100, Suite
B; Durham, NC 27713).  The document has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

Clopyralid [3,6-dichloro-2-pyridinecarboxylic acid]  is a pyridine
herbicide registered for use on a variety of food and feed crops in the
U.S. for the postemergence control of broadleaf weeds, particularly
thistles and clover.  Permanent tolerances are established for residues
of clopyralid in/on a wide variety of plant commodities at levels
ranging from 0.5 ppm in/on stone fruits to 500 ppm in/on grass forage
and hay [40 CFR §180.431(a)], including a tolerance of 1.0 ppm for
strawberry.  Permanent tolerances are also established for residues of
clopyralid in livestock commodities at levels ranging from 0.1 ppm in
eggs to 36 ppm in meat byproducts, except liver, of cattle, goats,
horses and sheep.  There currently are no tolerances for inadvertent or
indirect residues of clopyralid.

The Interregional Project No. 4 (IR-4) has submitted a petition
proposing the use of the 3 lb acid equivalent (ae)/gal emulsifiable
concentrate (EC) formulation of the monoethanolamine salt of clopyralid
(Stinger®; EPA Reg. No. 62719-73) on Swiss chard, members of the
bushberry subgroup (13-07B), and strawberries (FL and NC only).  The
proposed use on Swiss chard is for a single broadcast foliar application
no later than the 8-leaf stage at 0.094-0.187 lb ae/A, and the proposed
use on bushberries is for two soil-directed applications beginning one
week after bloom at up to 0.25 lb ae/A/application for a maximum of 0.5
lb ae/A/season, with a minimum retreatment interval (RTI) of 14 days.
The proposed use on strawberries is for a single broadcast foliar
application at 0.113-0.25 lb ae/A at up to 7 days prior to harvest; this
use is restricted to strawberries grown in FL and NC under an
annual-type production system.  All uses allow for applications using
only ground equipment.  The proposed minimum preharvest intervals (PHIs)
are 30 days for Swiss chard and bushberries, and 7 days for
strawberries.  In conjunction with the proposed uses on Swiss chard and
bushberries, IR-4 is proposing the following permanent tolerances for
clopyralid:

Swiss chard	5.0 ppm

Bushberry subgroup 13-07B	6.0 ppm

For the proposed use on strawberries, IR-4 is proposing the following
permanent tolerance for clopyralid with a regional restriction:

Strawberry (annual)	4.0 ppm

Based on the available cabbage, grass, wheat and barley metabolism
studies, the nature of clopyralid residues in plants is adequately
understood for purposes of this petition.  The residue of concern in
plants for both risk assessment and the tolerance expression is
clopyralid.

As the crop uses being proposed in this petition do not include any
regulated livestock feedstuffs, issues pertaining to residues in
livestock commodities are not relevant to the current petition.

An adequate gas chromatograph/electron-capture detection (GC/ECD) method
(Method ACR 75.6) is available for enforcing tolerances for clopyralid
in/on plant commodities.  In the submitted Swiss chard, blueberry and
strawberry field trials, residues of clopyralid in/on each commodity
were determined using a slightly modified version of the current
enforcement method.  The method was adequately validated in conjunction
with the analysis of field trial samples, and the lowest level of method
validation (LLMV) was 0.05 ppm for each crop.

The submitted Swiss chard, blueberry and strawberry field trial data are
adequate and support the proposed uses.  An adequate number of tests
were conducted on each crop in the appropriate geographic regions at ~1x
the maximum proposed rate, and the appropriate samples were collected
from each test around the proposed PHI.  Residues of clopyralid in/on
each commodity were determined using an adequate GC/ECD method, and the
duration and conditions of sample storage are supported by the available
storage stability data.  The available field trial data support
tolerances of 3.0 ppm for Swiss chard, 0.50 ppm for the bushberry
subgroup 13-07B, and 4.0 ppm for strawberries.

No processing data are required to support the proposed uses, and the
existing confined rotational crop study adequately supports the
rotational crop restrictions specified on the current label.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

Provided the label is modified to exclude use on low-growing varieties
of bushberry, there are no deficiencies in the subject petition that
would preclude establishing permanent tolerances for residues of
clopyralid on the proposed commodities.  The residue chemistry data
support tolerances for clopyralid at 3.0 ppm in/on Swiss chard and at
0.50 ppm in/on the bushberry subgroup 13-07B, except low-bush varieties.
 Based on the available data, the existing tolerance of 1.0 ppm in/on
strawberry should be increased to 4.0 ppm to support the proposed use
pattern in FL and NC (see Table 6).  HED notes that although a tolerance
for the bushberry subgroup 13-07B would include cranberry, the existing
tolerance for residues in/on cranberry should remain due to use pattern
differences between cranberry and the bushberry subgroup.  HED notes
that the recommended tolerances on bushberry and strawberry are not
harmonized with Canadian MRLs.  There are no residue chemistry
considerations that would preclude granting the regional registrations
for clopyralid.  A human health risk assessment for clopyralid is
forthcoming.  The tolerance definition for clopyralid should be revised
to read as follows:

Tolerances are established for residues of the herbicide clopyralid,
including its metabolites and degradates, in or on the commodities in
the table below as a result of the application of clopyralid.
Compliance with the tolerance levels specified below is to be determined
by measuring only clopyralid [3,6-dichloro-2-pyridinecarboxylic acid] in
or on the commodity.

Background

Clopyralid is a selective, postemergence pyridine herbicide that is used
for the control of broadleaf weeds, particularly thistles and clover, in
a variety of crops.  In the current petition (PP#8E7481), IR-4 is
proposing to expand the use of clopyralid to include applications to
Swiss chard and bushberries for the postemergence control of various
weeds.  In addition, IR-4 is proposing a regionally restricted use on
strawberries grown only in FL and NC under an annual-type production
system.  There is currently a use on strawberries grown as a perennial
crop (DP# 270507, 8/6/2002, D. Dotson).  The chemical structure and
nomenclature of the monoethanolamine salt of clopyralid is summarized in
Table 1, and the physicochemical properties of clopyralid are summarized
in Table 2.

Table1.	Clopyralid Nomenclature.

Compound

Common name	Clopyralid, monoethanolamine salt

Company experimental name	Dowco 290

IUPAC name	3,6-dichloropyridine-2-carboxylic acid, monoethanolamine salt

CAS name	3,6-dichloro-2-pyridinecarboxylic acid, monoethanolamine salt

CAS registry number	1702-17-6 (acid)

57754-85-5 (monoethanolamine salt)

End-use product (EP)	3 lb ae/gal EC (Stinger® herbicide; EPA Reg. No.
62719-73)

Table 2.	Physicochemical Properties of Technical Grade Clopyralid Acid.

Parameter	Value	Reference

Melting point/range	149.6	Data were obtained from the FOOTPRINT
Pesticide Properties DataBase, (  HYPERLINK
"http://www.eu-footprint.org/ppdb.html"
http://www.eu-footprint.org/ppdb.html ).

pH	Not available

	Density (specific gravity)	1.76 g/mL

	Water solubility (g/L) at 20°C	143

	Solvent solubility (g/L) at 20°C	Acetone – 250

Ethyl acetate – 102

Xylene – 4.6

Hexane – 6.0

	Vapor pressure at 25°C, mPa	1.36

	Dissociation constant, pKa, at 25°C	2.01

	Octanol/water partition coefficient, Log(KOW), at 20°C	-2.63

	UV/visible absorption spectrum	Not available

860.1200  Directions for Use

A 3.0 lb ae/gal EC formulation of clopyralid is currently registered to
Dow AgroSciences (Stinger®; EPA Reg. No. 62719-73) for use on a wide
variety of crops for the postemergence control of weeds.   IR-4 is
proposing new uses for this formulation on Swiss chard and members of
the bushberry subgroup.  Although there is an existing use for
clopyralid on perennial strawberries, with a 30-day PHI, IR-4 is also
proposing to establish a new use for strawberries grown under an annual
production system in the states of NC and FL.  Examples of supplemental
labels for the 3 lb ae/gal EC were provided, and the proposed use
directions are summarized below in Table 3.

Table 3.	Summary of Directions for Use of Clopyralid.

Applic. Timing, Type, and Equip. 1	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ae/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ae/A)	PHI

(days)	Use Directions and Limitations 2

Swiss Chard

Broadcast foliar application when crop is at the cotyledon to 8-leaf
stage of growth; ground equipment.	3.0 lb ae/gal EC [62719-73]
0.094-0.187	1	0.187	30	Apply in a minimum of 10 gal/A

Bushberry subgroup 13-07B

Directed applications to row middles beginning 1 week after bloom;
ground equipment 	3.0 lb ae/gal EC [62719-73]	0.06-0.25	2	0.5	30	Apply
in a minimum of 10 gal/A, with a minimum RTI of 14 days.  Do not apply
by aircraft.

Strawberry (annual fields only in FL and NC)

Broadcast foliar application to well-established plantings; ground
equipment	3.0 lb ae/gal EC [62719-73]	0.113-0.25	1	0.25	7	Apply in a
minimum of 20 gal/A.  Do not use with a surfactant.

Do not apply by aircraft

1	Do not apply through any type of irrigation system.

2	The label for the 3 lb ae/gal EC contains the following rotational
crop restrictions:  barley, canola, cole crops, flax, garden beets,
grasses, corn (field, pop and sweet), oats, spinach, sugar beets,
turnips and wheat may be planted at anytime following a treated crop.
Depending on the amount of soil organic matter, rainfall and location
(state), the plant-back intervals for all other crops range from 10.5 to
18 months.

Conclusions.  The labels are adequate to allow evaluation of the residue
data relative to the proposed uses.  The available field trial data
support the proposed use directions, although the label should be
revised to exclude use on low-growing varieties of bushberry.

860.1300 Nature of the Residue - Plants

DP# 270507, 8/6/2002, D. Dotson

The nature of the residue in plants is adequately understood for
purposes of this petition based on the acceptable cabbage, grass, barley
and wheat metabolism studies.  In each of these studies, the major
14C-residue was determined to be only parent compound.  Although data
are available for only two dissimilar crops (leafy vegetable and cereal
grain), HED has concluded that the residue of concern in plants for
purposes of this petition is clopyralid.  However, the Agency reserves
the right to require additional metabolism studies in the future should
the petitioner request the establishment of clopyralid tolerances for
additional crops.

860.1300 Nature of the Residue - Livestock

There are no livestock feedstuffs associated with the proposed use on
Swiss chard, bushberry subgroup 13-07B, and strawberry.  Therefore, data
requirements for livestock metabolism are not relevant to this tolerance
petition.

860.1340 Residue Analytical Methods

Enforcement method.  The Pesticide Analytical Manual (PAM) Vol. II lists
a GC/ECD method for determining residues of clopyralid residues in/on
plant commodities (Method I or Method ACR 75.6).

For this method, residues are extracted with dilute NaOH (0.25% or 0.1%)
and filtered.  The extract is then acidified and salinized, and residues
are partitioned into ethyl ether.  Residues are then methylated using
diazomethane and cleaned up on an activated Alumina column.  Residues
are then determined by GC/ECD using external standards.  The reported
LOQs are 0.5 ppm for grains and 2.0 ppm for green forage.

Data collection methods.  In the submitted field trials, residues of
clopyralid in/on samples of Swiss chard, blueberries and strawberries
were determined using a slightly modified version of the current
tolerance enforcement method.

For each commodity, residues were extracted with 0.5% NaOH and
centrifuged.  The resulting extract was acidified with HCl and salinized
with NaCl, and residues were partitioned into ethyl ether.  Residues
were then methylated using diazomethane, concentrated to dryness,
re-dissolved in toluene, and cleaned up using an activated Alumina A
column eluted with toluene.  The methylated residues were analyzed by
GC/ECD using external standards.  Residues are expressed in terms of
parent clopyralid using a conversion factor of 0.93.  The lowest level
of method validation (LLMV) for clopyralid in each commodity was 0.05
ppm.  The calculated LOQs were 0.052-0.073 ppm and the LODs were
0.017-0.024 ppm.

The above method was adequately validated using control samples of each
matrix fortified with clopyralid at 0.05-5.0 ppm.  Acceptable recoveries
were obtained for each matrix, and the fortification levels bracketed
the measured residue levels.  Apparent residues of clopyralid were <LOQ
in/on control samples, which the exception of two control samples from
one of the blueberry field trials which had apparent residues of
clopyralid at 0.060 and 0.055 ppm.

Conclusions.  An adequate GC/ECD method (Method ACR 75.6) is available
for enforcing the proposed tolerances and collecting data on residues of
clopyralid in Swiss chard, blueberries and strawberries.

860.1360 Multiresidue Methods

The FDA Pestrak database (PAM Vol. I, Appendix dated 11/6/90) indicates
that the existing FDA multiresidue methods are not likely to recover
clopyralid.  HED notes that clopyralid does appear to be adequately
recovered by the “QuEChERS” multiresidue method
(http://www.quechers.com).

860.1380 Storage Stability

DP# 270507, 8/6/2002, D. Dotson

Under frozen storage conditions, clopyralid has been shown to be stable
in plant commodities for the following durations: 50 months in safflower
seeds, soybeans, sugar beet roots and tops, and oat forage, grain and
straw; 30 months in strawberries; 26 months in dried hops cones; 16
months in cherries and plums; 15 months in canola meal; 10 months in
canola seed and oil; 9 months in cabbage and spinach; 5 months in
mustard greens; and 3 months in peaches.

Samples collected from the submitted field trials were stored frozen
within 3 hours after harvest, shipped frozen to the analytical
laboratory 2-40 days later, and stored at -21°C at the analytical
laboratory until analysis.  The maximum frozen storage intervals, from
harvest to analysis of samples, are listed in Table 4.

Table 4.	Summary of Storage Conditions and Durations of Samples from
Crop Field Trial Studies.

Matrix 	Storage Temperature  (°C)	Actual Storage Duration (days)
Interval of Demonstrated Storage Stability (months)

Swiss Chard	-21 ± 7	41-91	5 (Mustard Greens)

Blueberry	-21 ± 7	41-132	16 (Cherry)

Strawberry	-21 ± 7	90-99	30 (Strawberry)

Conclusions.  Adequate storage stability data are available to support
the sample storage conditions and durations in the submitted field
trials.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed use on
Swiss chard, bushberry subgroup 13-07B and strawberry.  Therefore, data
requirements pertaining to meat, milk, poultry, and eggs are not
relevant to this tolerance petition.

860.1500 Crop Field Trials

47604401.der (Swiss Chard)

47604402.der (blueberry)

47604403.der (strawberry)

IR-4 has submitted new field trial data supporting the proposed uses of
clopyralid (3 lb ae/gal EC) on Swiss chard and members of the bushberry
subgroup 13-07B.  Although there is an existing use for clopyralid on
strawberries grown under a perennial cropping system, IR-4 is requesting
a new use on strawberries grown in FL and NC under an annual production
system.  New strawberry field trial data have been submitted to support
this new use.    SEQ CHAPTER \h \r 1 The results from these field trials
are discussed below and the residue data are summarized in Table 5.

Table 5.	Summary of Residue Data from Crop Field Trials with Clopyralid
(EC).

Crop matrix	Total Applic. Rate  (lb ae/A)	PHI (days)	Residue Levels
(ppm) 1

	n	Min.	Max.	HAFT 1	Median	Mean	Std. Dev.

Swiss Chard (proposed use = 0.187 lb ae/A total application rate, 30-day
PHI)

Swiss Chard	0.093-0.103	28-29	8	0.05	0.70	0.62	0.34	0.34	0.22

	0.188-0.199

8	<0.05	1.90	1.60	0.57	0.69	0.69

Bushberry subgroup 13-07B (proposed use = 0.5 lb ae/A total application
rate, 30-day PHI)

Blueberry 3	0.483-0.525	27-33	14	<0.05	0.42	0.38	0.06	0.12	0.12

Strawberry, grown in FL and NC only  (proposed use = 0.25 lb ae/A total
application rate, 7-day PHI)

Strawberry	0.119-0.125	7-8	6	0.79	1.80	1.70	0.98	1.18	0.42

	0.246-0.255

6	1.60	3.00	2.85	2.40	2.35	0.53

1	Residues are expressed in terms for clopyralid acid.  The LLMV for
clopyralid was 0.05 ppm.  For all calculations, 0.05 ppm was used for
any residue values <LLMV.

2	HAFT = Highest Average Field Trial.

3  Residues from the field trial in ME, which used a foliar application,
have not been included in the summary of residue data.

Swiss Chard.  Four field trials were conducted on Swiss chard in Zones
1, 2 and 11 during the 2002 growing season.  In side-by-side tests at
each site, the monoethanolamine salt of clopyralid (3.0 lb ae/gal EC)
was applied to Swiss chard as a single broadcast foliar application
during vegetative development at rates of 0.093-0.103 lb ae/A or
0.188-0199 lb ae/A (0.5 and 1.0x the proposed rate).  Applications were
made using ground equipment in volumes of 16-60 gal/A, without the use
of a spray adjuvant.  Single control and duplicate treated samples of
Swiss chard (leaves and petioles) were harvested from each plot at
commercial maturity, 28-29 days after treatment (DAT).

Samples were stored at ≤-21°C for up to 3 months from harvest to
analysis; a duration that is supported by the available storage
stability data.  Samples were analyzed for residues of clopyralid using
an adequate GC/ECD method, which is a slightly modified version of the
current tolerance enforcement method (Method ACR 79.5).  The lowest
level of method LLMV for clopyralid in Swiss chard was 0.05 ppm.

Following a single broadcast foliar application of clopyralid (EC),
residues in/on Swiss chard harvested at 28-29 DAT were 0.05-0.70 ppm at
the 0.5x rate and <0.05-1.90 ppm at the 1x rate.  For the 0.5x and 1x
use rates, average residues were 0.34 and 0.69 ppm, respectively, and
the HAFT residues were 0.62 and 1.60 ppm.  A residue decline study was
not conducted.

Bushberry Subgroup 13-07.  Nine blueberry field trials were conducted in
Zones 1, 2, 5 and 12 during the 1999 and 2000 growing seasons.  Lowbush
type blueberries were treated at the one test site in ME (Zone 1), and
highbush type blueberries were treated at all the other test sites.  At
each site, the monoethanolamine salt of clopyralid (3 lb ae/gal) was
applied to blueberries as two applications during early fruit
development at rates of 0.240-0.264 lb ae/A, for a total rate of
0.490-0.525 lb ae/A/season (1x proposed rate).  For the lowbush
blueberry test, the two applications were made as broadcast foliar
applications.  For the highbush blueberry tests, the two applications
were made as directed applications to the ground between the crop rows,
avoiding contact with the bushes.  Applications were made at RTIs of
12-21 using ground equipment in volumes of 20-31 gal/A, without the use
of a spray adjuvant.  Single control and duplicate treated samples were
harvested from each site at commercial maturity, 27-33 DAT.

at ≤-21°C for up to 4.3 months from harvest to analysis; an interval
that is supported by the available storage stability data.  Samples were
analyzed for residues of clopyralid using an adequate GC/ECD method,
which is a slightly modified version of the current tolerance
enforcement method (Method ACR 79.5).  The LLMV for clopyralid in
blueberries was 0.05 ppm.

The residue data from one of the tests (Trial MI16) were excluded from
the dataset because clopyralid residues were found in controls samples
at levels similar to the residue levels in the associated treated
samples.  These data were not used in determining a recommended
tolerance level (see Appendix II).

Following two broadcast foliar application of clopyralid (EC) totaling
0.49 lb ae/A, residues were 4.7 and 5.8 ppm in/on blueberries harvested
at 28 DAT.  Following soil-directed application at rates ranging from
0.48 to 0.53 lb ae/A, residues were <0.05 – 0.42 ppm in/on blueberries
harvested 27-33 DAT.  Not including the foliar treatment, the average
residue was 0.11 pm and the highest average field trail (HAFT) residue
was 0.38 ppm.  A residue decline study was not conducted.

Strawberry (annual production system in FL and NC only).  Three field
trials were conducted in Zones 2 and 3 during the 2002 growing season on
strawberries growing in an annual-type production system.  In
side-by-side tests at each site, the monoethanolamine salt of clopyralid
(3.0 lb ae/gal EC) was applied to strawberries as a single broadcast
foliar application during fruiting at rates of 0.119-0.125 lb ae/A or
0.246-0.255 lb ae/A (0.5x and 1x the proposed use rate).  Applications
were made using ground equipment in volumes of 29-35 gal/A, without the
use of a spray adjuvant.  Single control and duplicate treated samples
of strawberries were harvested from each plot at commercial maturity,
7-8 DAT.

Samples were stored at ≤-21°C for up to 3 months from harvest to
analysis; a duration that is supported by the available storage
stability data.  Samples were analyzed for residues of clopyralid using
an adequate GC/ECD method, which is a slightly modified version of the
current tolerance enforcement method (Method ACR 79.5).  The LLMV for
clopyralid in strawberries was 0.05 ppm.

Following a single broadcast foliar application of clopyralid (EC),
residues in/on strawberries harvested at 7-8 DAT were 0.079-0.180 ppm at
the 0.5x rate and 1.60-3.00 ppm at the 1x rate.  For the 0.5x and 1x
rates, average residues were 1.18 and 2.35 ppm, respectively, and the
HAFT residues were 1.70 and 2.85 ppm.  A residue decline study was not
conducted.

Conclusions.  The Swiss chard, blueberry and strawberry field trials are
adequate and support the proposed use patterns.  An adequate number of
tests were conducted in the appropriate geographical regions, and
samples were analyzed for the residue of concern using an adequate data
collection method.  Adequate storage stability data are available to
support the storage conditions incurred in the field trials.  The data
support tolerances of 3.0 ppm in/on Swiss chard and 0.50 ppm in/on
bushberries, provided low-growing varieties are excluded.  The data also
support a 4.0 ppm in/on strawberries, with a regional restriction to FL
and NC.  The label should be revised to prohibit use on low-growing
varieties of bushberries since their morphology does not readily allow
for soil applications.  Furthermore, directions for a previously
established use on cranberry (a member of the bushberry group) are
significantly different than the currently proposed use; therefore, the
existing tolerance for cranberry should remain even if a tolerance for
the bushberry subgroup is established.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with Swiss chard, bushberry subgroup 13-07B, and strawberry.
Therefore, data requirements for processed food and feed are not
relevant to this tolerance petition.

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

An analytical standard for clopyralid is currently available in the EPA
National Pesticide Standards Repository (personal communication with
Dallas Wright, ACB, 6/12/2009).

860.1850/1900 Confined and Field Accumulation in Rotational Crops

DP#  193219, 8/4/93, G. Kramer

An acceptable confined rotational crop study is available for
clopyralid.  In this study, the total radioactive residues in/on
representative rotational crop commodities (lettuce, turnips, green
beans, and wheat) were below 0.01 ppm at plant-back intervals of 49-98
days following application of [14C]clopyralid to the soil at 0.29 lb
ae/A (1.17x the maximum seasonal rate for crops which can be rotated).

The current label for the 3 lb ae/gal EC of clopyralid allows for the
replanting of the following crops at anytime:  barley, canola, cole
crops, flax, garden beets, grasses, corn (field, pop and sweet), oats,
spinach, sugar beets, turnips and wheat.  The plant-back interval for
all other crops is 10.5 to 18 months depending on the amount of soil
organic matter, rainfall and location (state).

The established rotational crop restrictions are adequate.  Limited
field rotational crop studies are not required, and no tolerances are
required for inadvertent or indirect residues in rotational crops.

860.1550 Proposed Tolerances

Permanent tolerances are established for residues of clopyralid in/on a
wide variety of plant commodities at levels ranging from 0.5 ppm in/on
stone fruits to 500 ppm in/on grass forage and hay [40 CFR
§180.431(a)], including a 4.0 ppm tolerance on cranberry, which is a
member of the bushberry subgroup 13-07B, and a 1.0 ppm tolerance on
strawberry.  Permanent tolerances are also established for residues of
clopyralid per se in livestock commodities at levels ranging from 0.1
ppm in eggs to 36 ppm in meat byproducts, except liver, of cattle,
goats, horses and sheep.  Currently there are no tolerances for
inadvertent or indirect residues of clopyralid.  A summary of the
recommended tolerances for the petition are listed in Table 6.

An adequate number of field trials at ~1x the proposed use rate are
available for Swiss chard and blueberries to support permanent
tolerances on Swiss chard and the bushberry subgroup 13-07B (except
low-growing varieties), of which blueberry is the representative crop.
An adequate number of strawberry field trials were also conducted in
Zones 2 and 3 at 1x the proposed use rate to support a tolerance with a
regional restriction to NC and FL.  The Agency’s SOP “Guidelines for
Setting Pesticide Tolerances Based on Field Trial Data” were utilized
for determining the appropriate tolerance level for each commodity
(Appendix II).  The recommended tolerances on Swiss chard and the
bushberry subgroup 13-07B (except low-growing varieties) are 3.0 and
0.50 ppm, respectively.  On strawberries, the new use pattern results in
a recommended tolerance of 4.0 ppm.  As previously noted, the current
tolerance for cranberry at 4.0 ppm should remain even if tolerances for
the bushberry subgroup are established.

There are no Codex or Mexican maximum residue limits (MRLs) for residues
of clopyralid in/on the requested commodities (Appendix I).  However,
there are Canadian MRLs for residues of clopyralid at 1.0 mg/kg on
strawberry and 0.1 mg/kg on blueberry.  The Canadian MRL for strawberry
harmonizes with the existing tolerance on strawberry.  Based on the
proposed use on strawberry and bushberries, and the available residue
data, the recommended tolerances on strawberry and bushberries (subgroup
13-07B) cannot be harmonized with the Canadian MRLs.

Table 6. 	Tolerance Summary for Clopyralid.

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

40 CFR §180.431(a)

Swiss Chard	5.0	3.0	Adequate field trail data are available.

Bushberry subgroup 13-07B	6.0	0.50	Adequate field trail data are
available; however, the tolerance should be for the subgroup except
low-growing varieties.

Cranberry 	4.0	4.0	The tolerance on cranberries should remain due to
differences in use pattern and residue level versus the currently
proposed use on bushberry

Strawberry	4.0	4.0	Adequate field trial data are available to support a
7-day PHI on strawberries grown under an annual-type production system
in FL and NC only.  This tolerance will supersede the existing 1.0-ppm
tolerance already established on strawberry (grown under a perennial
production system).

References

DP Number:	193219

Subject:	ID#<PHONE_NUMBER>3.  Review of Confined Rotational Study of
Clopyralid.

From:		G. Kramer

To:		J. Miller

Date:		8/4/93

MRID:		42815001

DP Number:	D270507

Subject:	Clopyralid.  Review of Residue Chemistry Data in Support of
Permanent or Time-Limited Tolerances Proposed for Canola (PP#1E6291),
Cherries (PP#1E6329), Crambe (PP#1E6291), Cranberry (PP#1E6340), Flax
(PP#1E6227), Garden Beets (PP#1E6333), Head and Stem Brassica
(PP#1E6999), Hops (PP#1E6283), Mustard Greens (PP#1E6334), Peaches
(PP#1E6329), Plums (PP#1E6329), Spinach (PP#1E6320), Strawberries
(PP#1E6241), Sweet Corn (PP#4F4379), Popcorn (PP#4F4379), and Turnips
(PP#1E6335).

From:		Douglas A. Dotson

To:		S. Brothers/R. Forrest

Date:		8/6/2002

MRID:		41904401, 41904402, 41904403, 44212601, 45036101, 45259901,
45372801, 45372802, 45390001, 45419801, 45436901, 45436902, 45436903,
45446901, 45447001, 45447101, 45473601, and IR-4 Rpt No. PR 07223

  SEQ CHAPTER \h \r 1 Attachments:

Appendix I - International Residue Limit Status sheet

Appendix II - Tolerance Assessment Calculations

Appendix I.	International Residue Limit Status Sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  3,6-dichloro-2-pyridinecarboxylic acid	Common Name:
Clopyralid	X Recommended tolerances

 Reevaluated tolerance

 Other	Date:  07/20/09

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

√ No Codex proposal step 6 or above

No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP# 8E7481

DP #s: 361787

 No Limits

 No Limits for the crops requested	 No Limits

√  No Limits for the crops requested

Residue definition:  Clopyralid	Residue definition:  NA

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

Blueberry	0.1

Strawberry	1.0

	Notes/Special Instructions:

Appendix II.  Tolerance Assessment Calculations.

For each of the crops listed below, the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data (SOP), along with the tolerance
spreadsheet, was used for calculating recommended tolerances.  As
specified in the SOP, the minimum of the 95% upper confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile was selected as the tolerance value in cases when the dataset
was large (greater than 15 samples) and reasonably lognormal.  For
datasets that were small (≤15 samples) and reasonably lognormal, the
upper bound estimate of the 95th percentile based on the median residue
value was compared to the minimum of the 95% UCL on the 95th percentile
and the point estimate of the 99th percentile, and the minimum value was
selected as the tolerance value.  For datasets that were not lognormal,
the upper bound on the 89th percentile was selected as the tolerance
value (distribution-free method).  The rounding procedures specified in
the SOP were also used.

Swiss chard.  The dataset used to establish a tolerance for clopyralid
on Swiss chard consisted of field trial data representing a single
application at rates of 0.19-0.20 lb ae/A with a 28-29-day PHI.  As
specified by the SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values used to calculate the tolerance are
provided in Table II-1.

All but 2 field trial sample results for Swiss chard were above the LOQ
(0.05 ppm).  The Swiss chard dataset was small (8 samples).  The dataset
was entered into the tolerance spreadsheet.  Although the result from
the approximate Shapiro-Francia test statistic (Figure I-2) indicated
that the assumption of lognormality should not be rejected, visual
inspection of the lognormal probability plot (Figure II-1) provided in
the spreadsheet indicated that the dataset was not reasonably lognormal.
 Using the tolerance spreadsheet, the recommended tolerance is 3.0 ppm
on Swiss chard.

Table II-1.	Residue data used to calculate tolerance for Clopyralid on
Swiss Chard.

Regulator:	EPA

Chemical:	Clopyralid

Crop:	Swiss Chard

PHI:	28-29 days

App. Rate:	1 application at 0.19-0.20 lb ae/A

Submitter:	IR-4

MRID Citation:	MRID 47604401

	Residues

	0.05

	0.05

	0.12

	0.21

	0.92

	0.99

	1.3

	1.9

Figure II-   SEQ Figure_II- \* ARABIC  1 .  Lognormal probability plot
of Clopyralid field trial data for Swiss chard.

Figure II- 2.   Tolerance spreadsheet summary of Clopyralid field trial
data for Swiss Chard.

Bushberry subgroup 13-07B.

The dataset used to establish a tolerance for clopyralid on the
bushberry subgroup 13-07B consisted of field trial data on blueberries
at application rates of 0.483-0.525 lb ae/A (2 applications at
0.240-0.264 lb ae/A) with a 27-33 day PHI.  As specified by the SOP, the
field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table II-2.
Residues from the foliar application trial are not included in the
dataset.

The blueberry dataset is relatively large (14 samples).  The dataset was
entered into the tolerance spreadsheet.  The approximate Shapiro-Francia
test statistic (Figure II-4) indicates that the assumption of
lognormality should be rejected and visual inspection of the lognormal
probability plot for blueberry (Figure II-3) provided in the spreadsheet
supports that conclusion.  Therefore, the recommended tolerance on the
bushberry subgroup 13-07B is 0.50 ppm.

Table II-2.	Residue data used to calculate tolerance for Clopyralid on
Blueberry.

Regulator:	EPA

Chemical:	Clopyralid

Crop:	Blueberry

PHI:	27-33 Days

App. Rate:	2 applications at 0.240-0.264 lb ae/A

Submitter:	IR-4

MRID Citation:	MRID 47604402

	Residues

	0.05

	0.05

	0.05

	0.05

	0.05

	0.05

	0.056

	0.057

	0.064

	0.095

	0.16

	0.22

	0.34

	0.42

Figure II- 3.  Lognormal probability plot of Clopyralid field trial
data for Blueberry.

Figure II- 4.   Tolerance spreadsheet summary of Clopyralid field trial
data for Blueberry.

Strawberry (grown in an annual production strategy; FL and NC only)

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攃攀Ĵ瑹䠤]ఀThe dataset used to establish a tolerance for
clopyralid on strawberry consisted of field trial data representing a
single application at rates of 0.246-0.255 lb ae/A with a 7-8 day PHI.
As specified by the SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values used to calculate the tolerance are
provided in Table II-3.

All field trial sample results for strawberry were above the LOQ (0.05
ppm).  The strawberry dataset was small (6 samples).  The dataset was
entered into the tolerance spreadsheet.  Visual inspection of the
lognormal probability plot for strawberry (FigureII-5) provided in the
spreadsheet indicated that the dataset was reasonably lognormal.  The
result from the approximate Shapiro-Francia test statistic (Figure II-6)
confirmed that the assumption of lognormality should not be rejected for
strawberry.  Using the tolerance spreadsheet, the recommended tolerance
is 4.0 ppm on strawberries.

Table II-3.	Residue data used to calculate tolerance for Clopyralid on
Strawberry.

Regulator:	EPA

Chemical:	Clopyralid

Crop:	Strawberry (annual, grown only in FL)

PHI:	7-8 Days

App. Rate:	1 application at 0.246-0.255 lb ae/A

Submitter:	IR-4

MRID Citation:	MRID 47604403

	Residues

	1.6

	2.0

	2.1

	2.7

	2.7

	3.0

Figure II- 5.  Lognormal probability plot of Clopyralid field trial
data for Strawberry.

Figure II- 6.   Tolerance spreadsheet summary of Clopyralid field trial
data for Strawberry.

Clopyralid	Summary of Analytical Chemistry and Residue Data	DP#:  361787

 PAGE

Page   PAGE  1  of   NUMPAGES  19


[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Notices]
[Page 72864-72865]
[DOCID:fr07de05-129]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 18f-3; SEC File No. 270-385; OMB Control No. 3235-
0441

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Section 18(f)(1) \1\ of the Investment Company Act of 1940 \2\ (the
``Investment Company Act'') prohibits registered open-end management
investment companies (``funds'') from issuing any senior security. Rule
18f-3 under the Act \3\ exempts from section 18(f)(1) a fund that
issues multiple classes of shares representing interests in the same
portfolio of securities (a ``multiple class fund'') if the fund
satisfies the conditions of the rule. In general, each class must
differ in its arrangement for shareholder services or distribution or
both, and must pay the related expenses of that different arrangement.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 80a-18(f)(1).
    \2\ 15 U.S.C. 80a.
    \3\ 17 CFR 270.18f-3.
---------------------------------------------------------------------------

    The rule includes one requirement for the collection of
information. A multiple class fund must prepare, and fund directors
must approve, a written plan setting forth the separate arrangement and
expense allocation of each class, and any related conversion features
or exchange privileges (``rule 18f-3 plan'').\4\ Approval of the plan
must occur before the fund issues any shares of multiple classes and
whenever the fund materially amends the plan. In approving the plan, a
majority of the fund board, including a majority of the fund's
independent directors, must determine that the plan is in the best
interests of each class and the fund as a whole.
---------------------------------------------------------------------------

    \4\ Rule 18f-3(d).
---------------------------------------------------------------------------

    The requirement that the fund prepare and directors approve a
written rule 18f-3 plan is intended to ensure that the fund compiles
information relevant to the fairness of the separate arrangement and
expense allocation for each class, and that directors review and
approve the information. Without a blueprint that highlights material
differences among classes, directors might not perceive potential
conflicts of interests when they determine whether the plan is in the
best interests of each class and the fund. In addition, the plan may be
useful to Commission staff in reviewing the fund's compliance with the
rule.
    There are approximately 1,142 multiple class funds.\5\ Based on a
review of typical rule 18f-3 plans, the Commission's staff estimates
that the 1,142 funds together make an average of 571 responses each
year to prepare and approve a written rule 18f-3 plan, requiring
approximately 10 hours per response and a total of 5,710 burden hours
per year in the aggregate.\6\ The

staff estimates that preparation of the rule 18f-3 plan may require 4
hours of the services of an attorney or accountant employed by the
firm, at a cost of approximately $140 per hour for professional
time,\7\ and approval of the plan may require 1 hour of the attention
of each of 6 directors, at a cost of approximately $635 per hour per
director.\8\ The staff therefore estimates that the aggregate annual
cost of complying with the paperwork requirements of the rule is
approximately $2,495,270 ((4 hours x 1 professional x 571 responses x
$140) + (1 hour x 6 directors x 571 responses x $635)).
---------------------------------------------------------------------------

    \5\ This estimate is based on data from Form N-SAR, the semi-
annual report that funds file with the Commission.
    \6\ The estimate reflects the assumption that each multiple
class fund prepares and approves a rule 18f-3 plan every two years
when issuing a new class or amending a plan (or that 571 of all
1,142 funds prepare and approve a plan each year). The estimate
assumes that the time required to prepare a plan is 4 hours per plan
(or 2,284 hours for 571 funds annually), and the time required to
approve a plan is an additional 1 hour per director per plan (or
3,426 hours for 571 funds annually (assuming 6 directors per fund)).
    \7\ Hourly rates are derived from salary information compiled by
the Securities Industry Association. We used the annual salary
listed for the Deputy General Counsel position, adjusted upward by
35% to reflect possible overhead costs and employee benefits, to
make our estimate. See Securities Industry Association, Report on
Management and Professional Earnings in the Securities Industry
(2004) (available in part at http://www.careerjournal.com/salaryhiring
 (last visited Nov. 17, 2005)).

    \8\ Hourly rates are based on previous estimates, adjusted to
reflect a 27% reported increase in compensation during the 2003-2004
period. See Management Practice Inc. Bulletin: More Meetings Means
More Pay for Fund Directors (April 2005) (available at http://www.mfgovern.com
).

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

    The estimated annual burden of 5,710 hours represents an increase
of 937 hours over the prior estimate of 4,773 hours. The increase in
burden hours is attributable to a change in estimates of the number of
multiple class funds that are subject to the rule based on recent
Commission filings. For the most part, however, most funds require less
time to prepare the rule 18f-3 plans because they only need to amend
existing plans.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act. The estimate is not derived
from a comprehensive or even a representative survey or study of the
costs of Commission rules. Complying with this collection of
information requirement is mandatory. Responses will not be kept
confidential. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid control number.
    Written comments are invited on: (a) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burdens
of the collections of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collections of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Office of Information Technology, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549.

    Dated: November 29, 2005.
Jonathan G. Katz,
Secretary.
 [FR Doc. E5-6980 Filed 12-6-05; 8:45 am]

BILLING CODE 8010-01-P