[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Notices]
[Pages 11948-11950]
[FR Doc No: 2013-03869]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2013-0002-N-4]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requirements (ICRs) for clearance by the Office
of Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than April 22, 2013.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave. SE., Mail Stop 25, Washington, DC
20590, or Ms. Kimberly Toone, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB Control Number 2130-0533.''
Alternatively, comments may be transmitted via facsimile to (202) 493-
6216 or<PHONE_NUMBER>, or via email to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Toone at<EMAIL_ADDRESS>
Please refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 25, Washington, DC 20590 (telephone:
(202) 493-6292) or Ms. Ms. Kimberly Toone, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, Sec.  2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) Whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce

information requested. See 44 U.S.C. 3501.
    Below is a brief summary of the currently approved ICRs that FRA
will submit for clearance by OMB as required under the PRA:
    Title: Qualifications for Locomotive Engineers.
    OMB Control Number: 2130-0533.
    Abstract: Section 4 of the Rail Safety Improvement Act of 1988
(RSIA), Public Law 100-342, 102 Stat. 624 (June 22, 1988), later
amended and re-codified by Public Law 103-272, 108 Stat. 874 (July 5,
1994), required that FRA issue regulations to establish any necessary
program for certifying or licensing locomotive engineers. The
collection of information is used by FRA to ensure that railroads
employ and properly train qualified individuals as locomotive engineers
and designated supervisors of locomotive engineers. The collection of
information is also used by FRA to verify that railroads have
established required certification programs for locomotive engineers
and that these programs fully conform to the standards specified in the
regulation.
    Affected Public: Businesses.
    Respondent Universe: 733 railroads.
    Frequency of Submission: On occasion; annually; tri-annually.

                                                Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                            Total annual       Average time per    Total annual
           CFR section             Respondent universe       responses             response        burden  hours
----------------------------------------------------------------------------------------------------------------
240.9--Waivers...................  733 railroads......  3 waiver petitions.  1 hour.............               3
240.101/103--Cert. Prog.--         733 railroads......  50 amendments......  1 hour.............              50
 Amendmnts.
    --Cert. Prog.--New...........  20 railroads.......  20 programs........  40 hours...........             800
    --Final Review...............  20 railroads.......  20 reviews.........  1 hour.............              20
    --Material Modification to     733 railroads......  30 modified prog...  45 minutes.........              23
     Program.
240.105(b)--Selection Criteria     733 railroads......  50 examinations....  1 hour.............              50
 for DSLEs--Exams.
(c) Written Reports/               10 railroads.......  10 reports.........  1 hour.............              10
 Determinations of DSLE
 Performance Skills.
240.109/App. C--Prior Safety       17,667 candidates..  25 responses.......  60 minutes.........              25
 Conduct Data.
240.111/App C--Driver's License    17,667 candidates..  17,667 requests....  15 minutes.........           4,417
 Data.
    --NDR Match--notifications     733 railroads......  177 notices + 177    15 min. + 15 min...              89
     and requests for data.                              requests.
    --Written response from        733 railroads......  20 cases/comments..  15 minutes.........               5
     candidate on driver's lic.
     data candidates.
240.111(g)--Notice to RR of        53,000 candidates..  4 letters..........  15 minutes.........               1
 Absence of License.
240.111(h)--Duty to furnish data   733 railroads......  200 phone calls....  10 minutes.........              33
 on prior safety conduct as motor
 vehicle op..
240.113--Notice to RR Furnishing   17,667 candidates..  353 requests + 353   15 min./30 min.....             265
 Data on Prior Safety Conduct--                          responses.
 Diff. RR.
240.119--Self-referral to EAP re:  53,000 locomotive    50 self-referrals..  5 minutes..........               4
 active substance abuse disorder.   engineers.
240.121--Criteria--Vision/Hearing  20 railroads.......  20 copies..........  15 minutes.........               5
 Acuity Data--New Railroads.
240.121--Criteria--Vision/Hearing  733 railroads......  20 reports.........  1 hour.............              20
 Acuity Data--Cond. Certification.
240.121--Criteria--Vision/Hearing  733 railroads......  10 notifications...  15 minutes.........               3
 Acuity Data--Not Meeting
 Standards--Notice by Employee.
240.127--Criteria for Examining    733 railroads......  46 amended programs  48 hours + 8 hours.           7,704
 Skill Performance--Modification                         + 687 amended
 to Certification Program to                             programs.
 Include Scoring System.
240.201/221--List of Qualified     733 railroads......  733 updates........  60 minutes.........             733
 DSLEs.
240.201/221--List of Qualified     733 railroads......  733 updated lists..  60 minutes.........             733
 Loco. Engineers.
240.201/223/301--Loco. Engineers   53,000 candidates..  17,667 certificates  5 minutes..........           1,472
 Certificate.
    --False entry on certificates  N/A................  N/A................  N/A................             N/A
240.205--Data to EAP Counselor...  733 railroads......  177 records........  5 minutes..........              15
240.207--Medical Certificate       53,000 candidates..  17,667 certificates  70 minutes.........          20,612
 Showing Hearing/Vision Standards
 are Met.
    --Written determinations       733 railroads......  10 determinations..  2 hours............              20
     waiving use of corrective
     device.
240.219--Denial of Certification.  17,667 candidates..  30 letters + 30      1 hour.............              60
                                                         responses.
    --Notification to Employee of  733 railroads......  30 notifications...  1 hour.............              30
     Adverse Decision.
240.227--Canadian Certification    N/A................  N/A................  N/A................             N/A
 Data.
240. 229--Joint Operations--       321 railroads......  184 employee calls.  5 minutes..........              15
 Notice--not qualified.
240.309--RR Oversight Resp.:       15 railroads.......  6 annotations......  15 minutes.........               2
 Detected Poor Safety Conduct--
 Annotation.
Testing Requirements:
    240.209/213--Written Tests...  53,000 candidates..  17,667 tests.......  2 hours............          35,334
240.211/213--Performance Test....  53,000 candidates..  17,667 tests.......  2 hours............          35,334
240.303--Annual operational        53,000 candidates..  53,000 tests/docs..  2 hours............         106,000
 monitor observation.
240.303--Annual operating rules    53,000 candidates..  53,000 tests.......  1 hour.............          53,000
 compliance test.

Recordkeeping:
    240.215--Retaining Info.       733 railroads......  17,667 records.....  30 minutes.........           8,834
     Supporting Determination.
240.305--Engineer's Notice of Non- 53,000 engineers or  100 notifications..  5 minutes..........               8
 Qualification to RR --Relaying.    candidates.
    --Certification Denial or      1,060 engineers....  2 letters..........  30 minutes.........               1
     Revocation Status to other
     certifying railroad.
240.307--Notice to Engineer of     733 railroads......  900 letters........  1 hour.............             900
 Disqualification.
240.309--Railroad Annual Review..  51 railroads.......  51 reviews.........  40 hours...........           2,040
    --Report of findings.........  51 railroads.......  12 reports.........  1 hour.............              12
----------------------------------------------------------------------------------------------------------------

    Total Responses: 217,325.
    Estimated Total Annual Burden: 278,682 hours.
    Status: Regular Review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC, on February 13, 2013.
Rebecca Pennington,
Chief Financial Officer, Federal Railroad Administration.
[FR Doc. 2013-03869 Filed 2-19-13; 8:45 am]
BILLING CODE P


[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Pages 7137-7138]
[FR Doc No: 2016-02640]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2016-0004; OMB No. 1660-0098]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Citizen Corps Council Registration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the online registration process
for Citizen Corps Councils and Community Emergency Response Team
programs.

DATES: Comments must be submitted on or before April 11, 2016.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2016-0004. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Steven (Tyler) Krska, Emergency
Management Specialist, FEMA, PNP, Individual and Community Preparedness
Division,<PHONE_NUMBER> for additional information. You may contact the
Records Management Division for copies of the proposed collection of
information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Citizen Corps was launched as a Presidential
Initiative, Executive Order 13254, in 2002 with a mission to harness
the power of every individual through education, training, and
volunteer service to make communities safer, stronger, and better
prepared for the threats of terrorism, crime, public health issues, and
disasters of all kinds. Citizen Corps is FEMA's grassroots strategy to
strengthen collaboration between government and community leaders from
all sectors to engage the full community in preparedness, planning,
mitigation, response, and recovery. The Community Emergency Response
Team Program offers training that prepares people to help themselves,
their families and their neighbors in the event of a disaster in their
community.
    FEMA's Individual and Community Preparedness Division, which
administers Citizen Corps and the Community Emergency Response Team
program nationally, would like to revise its online information
collection process and forms by which local, tribal and territorial
Councils' and Community Emergency Response Teams submit profiles via
the national Web site. The Citizen Corps Council registration form will
allow FEMA and State personnel to ensure that prospective Councils/
CERT's have the support of the appropriate government officials in
their area, ensure a dedicated coordinator is assigned to the Council,
and will provide an efficient way to track the effectiveness of the
nationwide network of Councils and CERT's. Approved registration of a
Council or Community Emergency Response Team program allows them to be
recognized as official entities; become eligible for Homeland Security
grant funding; allows for the coordination of preparedness and
emergency management activities among other groups associated with
Citizen Corps; promote their local Councils to the public and become a
part of the Citizen Corps national directory of Councils; and receive
important updates and messages from the national office. The Citizen
Corps Council and Community Emergency Response Team registries support
the mission of FEMA's Individual and Community Preparedness Division
and Citizen Corps, to help achieve greater community resiliency
nationwide. This continuing registration process will allow the
Individual and Community Preparedness Division to collect information
that is more usable and provide a more efficient way to track the
effectiveness of the nationwide network of Councils and CERT's.

Collection of Information

    Title: Citizen Corps Council Registration.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0098.
    FEMA Forms: FEMA Form 008-0-25, Citizen Corps Council Registration.
    Abstract: FEMA's Community Preparedness Division would like to
revise a currently approved collection for its registration of State,
local, Tribal and territorial Councils and Community Emergency Response
Teams. The registration process allows for new Councils to submit
information on the Council or CERT to the State Citizen Corps Program
Manager for approval. The revised registration process will allow for
the collection of more valuable information and the tool is more user-
friendly for Citizen Corps Councils and CERT's.
    Affected Public: State, local or Tribal Government.
    Number of Respondents: 3,900.

    Number of Responses: 3,900.
    Estimated Total Annual Burden Hours: 3,900 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $93,249.00. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$378,690.00.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) Evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: February 3, 2016.
Richard W. Mattison,
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-02640 Filed 2-9-16; 8:45 am]
 BILLING CODE 9110-21-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Proposed Rules]
[Pages 24479-24481]
[FR Doc No: 2022-08782]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0440; Airspace Docket No. 19-AAL-45]
RIN 2120-AA66

Proposed Establishment of United States Area Navigation (RNAV)
Route T-376 in the Vicinity of Iliamna, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish United States Area
Navigation (RNAV) route, in the vicinity of Iliamna, AK. This action is
in support of a large and comprehensive RNAV T-route modernization
project for the state of Alaska.

DATES: Comments must be received on or before June 10, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building, Ground Floor Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-0440; Airspace Docket No. 19-AAL-45 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jesse Acevedo, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the 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 would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessoning the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2022-0440; Airspace Docket No. 19-AAL-45) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2022-0440; Airspace Docket No. 19-AAL-45.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

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

Background

    In 2003, Congress enacted the Vision 100--Century of Aviation
Reauthorization Act (Pub L., 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the nation's air
transportation system to make flying safer, more efficient, and more
predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive T-route modernization project in the state of Alaska. The
project's mission statement is ``to modernize Alaska's Air Traffic
Service route structure using satellite based navigation. Development
of new T-routes and optimization of existing T-routes will enhance
safety, increase efficiency and access, and will provide enroute
continuity that is not subject to the restrictions associated with
ground based airway navigation.'' As part of this project, the FAA
evaluated the existing Colored airway structure for: (1) Direct
replacement (i.e., overlay) with a T-route that offers a similar or
lower Minimum Enroute Altitude (MEA) or Global Navigation Satellite
System Minimum Enroute Altitude (GNSS MEA); (2) the replacement of the
Colored airway with a T-route in an optimized but similar geographic
area, while retaining similar or lower MEA; or (3) removal with no
route structure (T-route) restored in that area because the value was
determined to be insignificant.
    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from
dependency on Non-Directional Beacons (NDB), and move to develop and
improve the RNAV route structure. The FAA considers this transition as
time sensitive, given the increasing number of NDBs that are currently
and/or scheduled out of service, and the lack of an NDB acquisition,
maintenance, or sustainment program. This forces pilots flying under
Instrument Flight Rules (IFR), with aircraft not equipped with de-icing
protection, to fly at higher than normal MEAs, increasing the risk to
flight safety. The Iliamna, AK, (ILI) NDB and the Kacehmak, AK, (ACE)
NDB are two of the many NDBs scheduled for decommissioning. The
proposal to establish RNAV route, T-376, would support the
decommissioning of both ILI and ACE. Additionally, the proposed T-376
would support en route operations for Iliamna Airport (PAIL), Alaska.
Finally, the proposed RNAV route would provide an alternative for, and
eventually replace, the Colored airways Green 8 and Red 99.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to establish
RNAV route, T-376, in the vicinity of Iliamna, AK, in support of a
large and comprehensive T-route modernization project in the state of
Alaska. The proposed RNAV T-route is described below.
    T-376: T-376 is a new RNAV T-route that would extend between the
FAGIN, AK, waypoint (WP) and the Homer, AK, VHF Omnidirectional Radar/
Distance Measuring Equipment (VOR/DME).
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV route listed in this document would be published subsequently
in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1   [Amended]

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

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-376 FAGIN, AK to Homer, AK (HOM) [NEW]

FAGIN, AK                     WP                  (Lat. 59[deg]51'56.15'' N, long. 155[deg]32'43.30'' W)
VAYUT, AK                     WP                  (Lat. 59[deg]43'08.58'' N, long. 154[deg]55'24.16'' W)
WOLCI, AK                     WP                  (Lat. 59[deg]38'36.38'' N, long. 154[deg]37'31.77'' W)
JETIG, AK                     WP                  (Lat. 59[deg]30'38.31'' N, long. 154[deg]28'33.12'' W)
WUKSU, AK                     WP                  (Lat. 59[deg]29'31.36'' N, long. 153[deg]54'56.76'' W)
Homer, AK (HOM)               VOR/DME             (Lat. 59[deg]42'33.95'' N, long. 151[deg]27'23.76'' W)

* * * * *

    Issued in Washington, DC, on April 20, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-08782 Filed 4-25-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 30, 2008 (Volume 73, Number 211)]
[Notices]
[Page 64640-64641]
[DOCID:fr30oc08-77]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 6e-2 and Form N-6EI-1; SEC File No. 270-177; OMB Control
No. 3235-0177.

    Notice is hereby given that, pursuant to the Paperwork Reduction
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Commission (the

``Commission'') is soliciting comments on the collection of information
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extension and approval.
    Rule 6e-2 (17 CFR 270.6e-2) under the Investment Company Act of
1940 (``Act'') (15 U.S.C. 80a) is an exemptive rule that permits
separate accounts, formed by life insurance companies, to fund certain
variable life insurance products. The rule exempts such separate
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others, on condition that they comply with all but certain designated
provisions of the Act and meet the other requirements of the rule. The
rule sets forth several information collection requirements.
    Rule 6e-2 provides a separate account with an exemption from the
registration provisions of section 8(a) of the Act if the account files
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    Paragraph (b)(9) of rule 6e-2 provides an exemption from the
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and certain other conditions. Section 17(f) requires that every
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management accounts that offer life insurance contracts subject to rule
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    Since 2005, there have been no filings under paragraph (b)(9) of
rule 6e-2 by management accounts. Therefore, since 2005, there has been
no cost or burden to the industry regarding the information collection
requirements of paragraph (b)(9) of rule 6e-2. In addition, there have
been no filings of Form N-6EI-1 by separate accounts since 2005.
Therefore, there has been no cost or burden to the industry since that
time. The Commission requests authorization to maintain an inventory of
one burden hour for administrative purposes.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
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Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Please direct your written comments to Lewis W. Walker, Acting
Director/CIO, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>
    Dated: October 22, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-25863 Filed 10-29-08; 8:45 am]

BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		23-September-2009

Subject:	Spirodiclofen.  Dietary Risk Assessment in Support of the Requested use on Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and Star Apple.

PC Code:  124871	DP Barcode:  D367559

Decision No.:  404221	Registration No.:  264-830

Petition No.:  8F7500	Regulatory Action:  Section 3

Risk Assessment Type:  single chemical; dietary	Case No.:  none

TXR No.:  not applicable	CAS No.:  148477-71-8

MRID Nos:  none	40 CFR:  180.608

From/To:	Tom Bloem, Chemist

Risk Assessment Branch I/Health Effects Division (RABI/HED; 7509P)

Through:		Amelia Acierto, Chemist, RABIII/HED

		Mohesen Sahafeyan, Chemist, RABVI/HED

		Dietary Exposure Science Advisory Council (DESAC)

				George F. Kramer, Ph.D., Senior Chemist

				HED/RAB1 (7509P)

Executive Summary

Chronic and cancer dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID(, ver. 2.03) in support of Section 3 registration for application of spirodiclofen to avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple.  Acute dietary risk assessment was not conducted since an appropriate endpoint attributable to a single dose was not identified for the general U.S. population or any population subgroup.  The chronic and cancer analyses assumed the following:  (1) average field trial residues; (2) experimentally determined processing factors for apple and grape processed commodities and for citrus oil, peeled citrus, and citrus peel (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) BEAD projected average percent crop treated estimates for hop (92%), pome fruit (15%), stone fruit (10%), grape (7%), and citrus (14%); (4) drinking water estimates derived from the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) model (citrus application scenario; 1 x 0.31 lb ai/acre) and (5) maximum reasonably balanced livestock diets.  The resulting chronic risk estimates (food and water) were ≤3.3% cPAD and are not of concern to HED (infants (<1 year old) were the most highly exposed population).  The cancer risk estimate (food and water) for the U.S. population was 3 x 10-6.  The major contributors to the cancer analysis were hop (40%; assumes 100% transfer of residues from hop to beer; spirodiclofen Log KOW = 5.83), water (19%; 87% of the basin cropped and 100% crop treated), and orange (17%; pending submission of a new processing study, default processing factors were assumed).

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD; NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).  The most recent dietary risk assessment for spirodiclofen was conducted by Mohsen Sahafeyan (D346757, 3-Jan-2008).

II.	Residue Information

Residues of Concern in Plants and Livestock:  Table 1 is a summary of the conclusion made by HED concerning the residues of concern in fruit crops, livestock, and drinking water (Risk Assessment Document:  D285047, M Clock-Rust et al, 22-Jun-2005; residue chemistry reviews:  D341847, T. Bloem, 25-Oct-2007 and D359773, T. Bloem, 24-Jun-2009).

Table 1:  Residues of Concern for Tolerance Expression and Risk Assessment.

Matrix	Residues included in Risk Assessment	Residues included in Tolerance Expression

Citrus fruit, Pome Fruit, Stone Fruit, Tree Nut1	spirodiclofen spirodiclofen

Grape1	spirodiclofen	spirodiclofen, BAJ 2510

Livestock - Ruminants	spirodiclofen, BAJ 2510	spirodiclofen, BAJ 2510

Livestock - Poultry	no data submitted

Rotational Crops	no data submitted

Drinking Water	spirodiclofen, BAJ 2510, BAJ 2740-dihydroxy, BAJ 2740-ketohydroxy	not applicable

1  Pending the submission of the orange processing data, human-health risk assessments should assume default processing factors for all processed commodities excluding the processed commodities for apple and grape (D341847, T. Bloem, 25-Oct-2007).

Recommended Tolerances:  The current petition is for application to avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple (1 x 0.31 lb ai/acre; 2-day preharvest interval).  HED determined that the conclusions concerning the residues of concern in the currently registered fruit crops may be extended to the requested crops (see Table 1).  Based on the review of the residue chemistry data submitted in support of the current petition (D363343, T. Bloem, 22-Sep-2009), HED concluded that a 1.0 ppm tolerance for residues of spirodiclofen per se in/on the requested crops is appropriate.

Plant Residues Used in the Chronic/Cancer Risk Assessments:  The chronic and cancer dietary analyses incorporated projected average percent crop treated estimates and average field trial residues (see Table 2).  Default processing factors were assumed for all commodities excluding the processed commodities derived from apple and grape and for citrus oil, peeled citrus, and citrus peel where experimentally determined processing factors were incorporated (see Table 2).  To confirm that the projected percent crop treated estimates remained appropriate, HED requested a screening level usage analysis (SLUA) for the registered crops (see Attachment 2).  The projected percent crop treated estimates are greater than the SLUA for all relevant crops.  Since the projected percent crop treated estimates are for crops registered in 2007, HED concludes that incorporation of the SLUA data into a dietary analysis is not appropriate at this time.

Livestock Residues Used in the Chronic/Cancer Risk Assessments:  The recommended ruminant tolerances were based on maximum theoretical dietary burdens (no poultry/hog feed commodities proposed/registered).  A more realistic dietary burden (DB) was calculated for ruminants using the revised Table 1 feedstuffs.  Guidance submitted along with the revised Table 1 indicates that all three feed commodities associated with spirodiclofen (dried citrus pulp (beef and dairy), wet apple pomace (dairy only), and almond hulls (dairy only)) are considered alternative feedstuffs and only one these should be included in livestock dietary burden calculations.  Of these three commodities, almond hulls and wet apple pomace yields the highest dietary burden estimates for dairy and beef cattle, respectively.  The guidance associated with revised Table 1 indicates that almond hulls can be fed at up to 10% of the dairy cattle diet but 5% is more likely.  Since the refined livestock residue estimates are for a chronic analysis, HED concluded that almond hulls will be consumed at 5% of the dairy cattle diet.  In addition, the dietary burden calculations for diary cattle were used for determination of residues in tissues as diary cattle are ultimately slaughtered for meat.  Tables 3 and 4 are summaries of the dietary burden calculations and ruminant residue estimate, respectively.

Table 2:  Summary of Residue Estimates for the Chronic and Cancer Dietary Exposure Analyses.

Matrix	Avg Fld Trl Res and Projected Ruminant Residues (ppm)	% Crop Treated Estimates1	Processing Factors	Crop Translation and/or Comments

pome fruit	apple2 - 0.146	15	apple sauce - 0.07x; dried apple - 0.18x; peeled apple - 0.15x; juice - 0.03x	Apple and pear residues - D285249, T. Bloem, 18-Apr-2005.

Apple processing study - D341847, T. Bloem, 25-Oct-2007; dried apple and apple juice processing factors translated to dried pear and pear juice.

Per the suggestion of BEAD, the 15% projected average apple percent crop treated estimate was translated to all crops in the pome fruit crop group.

	pear2 - 0.239	15	dried pear - 0.18x; pear juice - 0.03x

	citrus fruit	orange2 - 0.104	14	peeled fruit - 0.06x; juice - 1.8x (default); oil - 69x; peel - 1.2x	Orange, lemon, and grapefruit residues - D285249, T. Bloem, 18-Apr-2005.

Orange processing study - D285249, T. Bloem, 18-Apr-2005; orange peeled fruit and peel processing factors translates to all citrus peeled and peel commodities.

Per the suggestion of BEAD, the 14% projected average orange percent crop treated was translated to all citrus except grapefruit temple oranges.

	lemon2 - 0.121	14	juice - 2.0x (default)

grapefruit2 - 0.103	13	juice - 2.1x (default)

	tree nut	almond2 - 0.023	100	--	Almond and pecan residues -D285249, T. Bloem, 18-Apr-2005.

	pecan2 -0.019	100	--

	stone fruit	peach2 - 0.368	10	dried peach - 7.0x (default)	Peach, plum and cherry residues - D285249, T. Bloem, 18-Apr-2005.

per the suggestion of BEAD, the 10% projected average peach percent crop treated estimate was translated to all crops in the stone fruit crop group.

	plum2 - 0.068	10	prune dried - 5.0x (default)

prune juice - 1.4x (default)

cherry2 - 0.286	10	juice - 1.5x (default)

	grape	grape - 0.697	7	raisin - 4.3x; juice - 0.17x	Grape residues - D285249, T. Bloem, 18-Apr-2005; grape processing factors - D341847, T. Bloem, 25-Oct-2007.

hop	hop -  11.6	92	--	-	Hop residues - 47105301.der.doc (14-day PHI).

avocado	avocado - 0.110	100	--	-	Avocado residue translated to black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple based on Reviewer’s Guide and Summary of HED ChemSAC Approvals for Amending Commodity Definitions [40CFR § 180.1(h)] and Crop Group/Subgroups [40 CFR § 180.41] (B. Schneider; 14-Jun-2002).  Default processing factors assumed for papaya.

cattle, goat, sheep, horse	liver - 0.0009	--	--	-	See Tables 3 and 4.

Residue in kidney translated to meat byproducts (highest of liver, kidney, and fat).

Since spirodiclofen may concentrate in milk fat (Kow=5.83), residues in milk fat were estimated using the default 25x milk fat concentration factor (0.0002 ppm x 25 = 0.005 ppm).

	kidney - 0.004	--	--

muscle - 0.0001	--	dried beef - 1.92x (default)

fat - 0.0007	--	--

meat bypdcts - 0.004	--	--

whole milk - 0.0002	--	--

milk fat - 0.005	--	--

	1	See attachment 1.

2	Representative crops translated to the remaining crops according to HED SOP 2000.1.

Table 3:  Calculation of Spirodiclofen Dietary Brudens.

Feed Commodity	% Dry Matter1	% Diet1	Average Residue (ppm)2	Dietary Contribution (ppm)3

Beef Cattle

almond hull	90	5	7.20	0.40

MTDB	--	10	--	0.41

Diary Cattle

almond hull	90	5	7.20	0.40

MTDB	--	10	--	0.41

1	Revised Table 1 Feedstuffs (June 2008).

2	Average almond hull field trial residue (D285249, T. Bloem, 18-Apr-2005)

3	Dietary contribution = tolerance ( % dry matter x % diet.

Table 4:  Summary of Cattle Feeding Study and Projected Residue.

Dose; ppm (DBx)	Residue (ppm)	Projected Residue Assuming  a 0.41 ppm dietary burden

	Spirodiclofen	BAJ 2510	Total

	liver

1.38 (3.4x)	not analyzed

4.12 (10.0x)	not analyzed

13.75 (33.5x)	<0.01	0.01-0.02	<0.02-<0.03	0.0009

kidney

1.38 (3.4x)	not analyzed

4.12 (10.0x)	<0.01	<0.01-0.03	<0.01-<0.04	0.004

13.75 (33.5x)	<0.01	0.04-0.09	<0.05-<0.10	0.003

muscle

1.38 (3.4x)	not analyzed

4.12 (10.0x)	not analyzed

13.75 (33.5x)	<0.002	<0.002	<0.004	0.0001

fat

1.38 (3.4x)	not analyzed

4.12 (10.0x)	<0.002	<0.002	<0.004	0.0004

13.75 (33.5x)	0.003-0.021	<0.002-0.008	<0.005-0.024	0.0007

whole milk (days 4, 8, 12, 16, 20, 24, 26, and 28)1

1.38 (3.4x)	not analyzed

4.12 (10.0x)	not analyzed

13.75 (33.5x)	<0.001-0.003	<0.001-0.003	<0.002-0.006	0.0002

whey2

1.38 (3.4x)	not analyzed

4.12 (10.0x)	not analyzed

13.75 (33.5x)	<0.001	<0.001-0.001	<0.002	0.00006

cream2

1.38 (3.4x)	not analyzed

4.12 (10.0x)	not analyzed

13.75 (33.5x)	0.005-0.012	<0.002- 0.002	<0.008- <0.014	0.0004

1	In milk collected from animals dosed at 13.75 ppm, combined residues of spirodiclofen and BAJ 2510 reached a plateau within the first week of treatment ((0.004 ppm); however, a peak of 0.006 ppm was observed in a single animal on day 20 of dosing.

2	A milk sample collected from animals dosed at 13.75 ppm with combined residues of 0.004 ppm was processed into whey and cream.

III.  Drinking Water Data

Surface and ground estimated drinking water concentrations were previously generated by the Environmental Fate and Effects Division (EFED) using PRZM-EXAMS and Screening Concentration in Ground Water Model (SCI-GROW), respectively (D311291, F. Kahn, 4-Jan-2005).  The SCI-GROW model was run using the highest application rate (1 x 0.53 lb ai/acre) and resulted in a point estimate of 0.44 ppb.  Multiple crop scenarios were modeled using PRZM-EXAMS (citrus, pecan, apple, peach, and grape; 87% cropped and 100% crop treated assumed) with citrus (1 x 0.31 lb ai/acre) resulting in the highest 1-in-10-year peak concentration (23.86 ppb), 1-in-10-year yearly average (4.99 ppb), and 30-year average (1.67 ppb).  Since the applications rates proposed as part of the current petition are identical to the citrus application rate, HED concludes that the previously generated water estimates remain relevant.  Therefore, the chronic and cancer analyses employed the citrus 1-in-10-year yearly average (4.99 ppb) and 30-year average (1.67 ppb), respectively.

IV.   DEEM-FCID( Program and Consumption Information

Spirodiclofen chronic dietary exposure assessments were conducted using the DEEM-FCID( (ver. 2.03), which incorporates consumption data from USDA’s CSFII (1994-1996 and 1998).  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (i.e., apple pie) are linked to EPA-defined food commodities (i.e., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups:  the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (i.e., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

IV.	Toxicological Information

Table 5 below summarizes the endpoints selected for dietary exposure analyses; for more detailed discussion on these endpoints see the HED risk assessment D363343 (in draft).

Table 5:  Summary of Toxicological Doses and Endpoints.

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern	Study and Toxicological Effects

Acute Dietary	An appropriate endpoint attributable to a single dose was not identified.

Chronic Dietary (All Populations)	NOAEL= 1.38 mg/kg/day	UF = 100

FQPA SF= 1x	cRfD = 0.014 mg/kg/day

cPAD = 0.014 mg/kg/day	Chronic Oral Toxicity Study in Dogs:  LOAEL= 4.7 mg/kg/day based on increased relative adrenal weights in both sexes, increased relative testis weight in males and histopathology findings in the adrenal gland of both sexes.

Cancer 	Classification: “Likely to be Carcinogenic to Humans” with Q1* (mg/kg/day)-1 = 1.49 x 10-2.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  FQPA SF = FQPA Safety Factor.  RfD = reference dose.

V.	Results/Discussion

The chronic risk estimates (food and water) were ≤3.3% cPAD and are not of concern to HED (infants (<1 year old) were the most highly exposed population).  The cancer risk estimate (food and water) for the U.S. population was 3 x 10-6.

Table 6:  Summary of Chronic Dietary Exposure and Risk.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	%cPAD1

General U.S. Population	0.014	0.000256	1.8

All Infants (< 1 year old)

0.000455	3.3

Children 1-2 years old

0.000432	3.1

Children 3-5 years old

0.000351	2.5

Children 6-12 years old

0.000213	1.5

Youth 13-19 years old

0.000162	1.2

Females 13-49 years old

0.000201	1.4

Adults 20-49 years old

0.000283	2.0

Adults 50+ years old

0.000213	1.5

1  The bolded %cPAD represents the population with highest risk.

Table 7:  Summary of Cancer Dietary Exposure and Risk.

Population Subgroup	Q1*	Exposure (mg/kg/day)	Risk

General U.S. Population	0.0149	0.000186	3 x 10-6

VI.	Characterization of Inputs/Outputs

The chronic and cancer analyses assumed the following:  (1) average field trial residues; (2) experimentally determined processing factors for apple and grape processed commodities and for citrus oil, peeled citrus, and citrus peel (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) BEAD projected average percent crop treated estimates for hop (92%), apple (15%), peach (10%), grape (7%), and orange (14%); (4) drinking water estimates derived from the PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre); and (5) maximum reasonably balanced livestock diets.  In response to an HED inquiry, BEAD indicated that it is appropriate to translate the projected percent crop treated estimates for peach, apple, and orange to the remaining crops in the stone fruit, pome fruit, and citrus crop groups, respectively.

Since the analysis made use of average residues derived from crop field trial studies (maximum application rate and minimum preharvest interval), incorporated maximum theoretical processing factors for citrus juice, and incorporated surface drinking water estimates which assumed 87% of the basin is cropped and 100% of the crops are treated at the maximum rate, HED concludes that the exposure estimates provided in this document are unlikely to underestimate actual exposure.

HED is generally concerned when the cancer risk exceeds 10-6.  Based on a critical commodity analysis conducted in DEEM-FCID(, the major contributors to the cancer risk were hops (40% of the total exposure), water (19% of the total exposure), and orange juice (16% of the total exposure).  HED notes the following concerning the residue estimates for hop, water, and orange juice:  (1) hop - DEEM-FCID( assumes that 100% of the residue in hops are transferred to beer during the brewing process (no residue remain in/on the spent hops); based on the spirodiclofen log KOW of 5.83, this is a conservative assumption; in addition, assumed 92% crop treated for hops (average projected percent crop treated estimate); (2) water - the water residue estimate assumed 87% of the basin is cropped with 100% of the crops treated; and (3) orange juice - pending the submission of a new orange processing study, default citrus juice processing factors are to be assumed (D341847, T. Bloem, 25-Oct-2007); in addition, assumed 14% crop treated for orange juice (average projected percent crop treated estimate).  Therefore, HED concludes that the cancer risk estimate provided in this assessment is conservative and actual cancer risk will be significantly lower than 3 x 10-6.

HED notes that spirodiclofen PDP monitoring data are available for almonds, apple juice, raisin, and heavy cream (<LOD residues in/on all samples).  Since these commodities contributed only 4% to the total cancer exposure estimate, it was determined that incorporation of these data were unnecessary.

VII.	Conclusions

Aggregate (food + water) chronic and cancer dietary risk analyses for spirodiclofen were conducted using DEEM-FCID (ver 2.00) to support the Section 3 registration of spirodiclofen on avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple.  The chronic and cancer analyses assumed the following:  (1) average field trial residues; (2) experimentally determined processing factors for apple and grape processed commodities and for citrus oil, peeled citrus, and citrus peel (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) BEAD projected average percent crop treated estimates for hop (92%), pome fruit (15%), stone fruit (10%), grape (7%), and citrus (14%); (4) drinking water estimates derived from the PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre); and (5) maximum reasonably balanced livestock diets.  The resulting chronic risk estimates (food and water) were ≤3.3% cPAD and are not of concern to HED (infants (<1 year old) were the most highly exposed population).  The cancer risk estimate (food and water) for the U.S. population was 3 x 10-6.  The major contributors to the cancer risk were hop (40%), water (19%), and orange juice (16%).

VIII.		List of Attachments

Attachment 1:	BEAD Projected Percent Crop Treated Estimates.

Attachment 2:	BEAD SLUA

Attachment 2:	DEEM-FCID( Chronic Residue File.

Attachment 3:	DEEM-FCID( Chronic Exposure Estimates.

Attachment 4:	DEEM-FCID( Cancer Residue File.

Attachment 5:	DEEM-FCID( Cancer Exposure Estimates.

Attachment 6:	DEEM-FCID( Critical Commodity Analysis for Cancer.

cc with all attachments:  J. Herbert/Rita Kumar (RD; RM 07; 7505P)

T. Bloem:S10945:Potomac Yard 1:703-605-0217:7509P:RAB1

Attachment 1:  BEAD Projected Percent Crop Treated Estimates; (J. Alsadek, DP # 340691, August 2007)

Crop/New Use	Market Leader	AVG. PCT/Chronic	Max. PCT/Acute

Year	ML	Avg.

	Hops	Abamectin

Abamectin	97

92	99

84	92	99

Oranges, excluding Temples	Abamectin

Abamectin

Abamectin	05

03

01	16

12

14	14	16

Grapes, All	Fenpropathrin/Imidacloprid

Abamectin

Propargite	05

03

01	8

5

9	7	9

Peaches	Hexythiazox

Fenbutatin-oxide

Fenbutatin-oxide	05

03

01	7

11

13	10	13

Apples	Pyridaben

Fenpropathrin/Formetanate

Pyridaben 	05

03

01	16

12

17	15	17

References:

National Center for Food & Agricultural Policy (NCFAP), 1992 and 1997

Agricultural Chemical Usage 2001 Fruit Summary, August 2002

Agricultural Chemical Usage 2003 Fruit Summary, August 2004

Agricultural Chemical Usage 2005 Fruit Summary, July 2006

Note: Average %CT of 13% for grapefruit, based on its use in 2005 was recommended by J. Alsadek (personal communication, 11/20/07)

Attachment 2:  BEAD SLUA

 Attachment 3:  DEEM-FCID( Chronic Residue File.

Filename: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit\124871chronic.R98

Chemical: spirodiclofen

RfD(Chronic): .014 mg/kg bw/day  NOEL(Chronic): 1.38 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0149

Date created/last modified: 08-04-2009/07:41:30/8          Program ver. 2.03

Comment: no acute endpoint identified; 100x uncertainity factor for chronic

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95000200 O    Avocado                            0.110000   1.000  1.000

95000740 O    Canistel                           0.110000   1.000  1.000

95001750 O    Grape                              0.697000   1.000  0.070

95001760 O    Grape, juice                       0.697000   0.170  0.070

95001761 O    Grape, juice-babyfood              0.697000   0.170  0.070

95001770 O    Grape, leaves                      0.697000   1.000  0.070

95001780 O    Grape, raisin                      0.697000   4.300  0.070

95001790 O    Grape, wine and sherry             0.697000   1.000  0.070

95001880 O    Hop                               11.600000   1.000  0.920

95002150 O    Mango                              0.110000   1.000  1.000

95002151 O    Mango-babyfood                     0.110000   1.000  1.000

95002160 O    Mango, dried                       0.110000   1.000  1.000

95002170 O    Mango, juice                       0.110000   1.000  1.000

95002171 O    Mango, juice-babyfood              0.110000   1.000  1.000

95002450 O    Papaya                             0.110000   1.000  1.000

95002451 O    Papaya-babyfood                    0.110000   1.000  1.000

95002460 O    Papaya, dried                      0.110000   1.800  1.000

95002470 O    Papaya, juice                      0.110000   1.500  1.000

95003330 O    Sapote, Mamey                      0.110000   1.000  1.000

86010000 O    Water, direct, all sources         0.004990   1.000  1.000

86020000 O    Water, indirect, all sources       0.004990   1.000  1.000

21000440 M    Beef, meat                         0.000100   1.000  1.000

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000

21000460 M    Beef, meat byproducts              0.004000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.004000   1.000  1.000

21000470 M    Beef, fat                          0.000700   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.000700   1.000  1.000

21000480 M    Beef, kidney                       0.004000   1.000  1.000

21000490 M    Beef, liver                        0.000900   1.000  1.000

21000491 M    Beef, liver-babyfood               0.000900   1.000  1.000

23001690 M    Goat, meat                         0.000100   1.000  1.000

23001700 M    Goat, meat byproducts              0.004000   1.000  1.000

23001710 M    Goat, fat                          0.000700   1.000  1.000

23001720 M    Goat, kidney                       0.004000   1.000  1.000

23001730 M    Goat, liver                        0.000900   1.000  1.000

24001890 M    Horse, meat                        0.000100   1.000  1.000

26003390 M    Sheep, meat                        0.000100   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000

26003400 M    Sheep, meat byproducts             0.004000   1.000  1.000

26003410 M    Sheep, fat                         0.000700   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.000700   1.000  1.000

26003420 M    Sheep, kidney                      0.004000   1.000  1.000

26003430 M    Sheep, liver                       0.000900   1.000  1.000

27002220 D    Milk, fat                          0.005000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.005000   1.000  1.000

27012230 D    Milk, nonfat solids                0.000200   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000

27022240 D    Milk, water                        0.000200   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.000200   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.000200   1.000  1.000

10001060 10   Citrus citron                      0.104000   1.000  0.140

10001070 10   Citrus hybrids                     0.104000   0.060  0.140

10001080 10   Citrus, oil                        0.121000  69.000  0.140

10001800 10   Grapefruit                         0.103000   0.060  0.130

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130

10001970 10   Kumquat                            0.104000   0.060  0.140

10001990 10   Lemon                              0.121000   0.060  0.140

10002000 10   Lemon, juice                       0.121000   2.000  0.140

10002001 10   Lemon, juice-babyfood              0.121000   2.000  0.140

10002010 10   Lemon, peel                        0.121000   1.200  0.140

10002060 10   Lime                               0.121000   0.060  0.140

10002070 10   Lime, juice                        0.121000   2.000  0.140

10002071 10   Lime, juice-babyfood               0.121000   2.000  0.140

10002400 10   Orange                             0.104000   0.060  0.140

10002410 10   Orange, juice                      0.104000   1.800  0.140

10002411 10   Orange, juice-babyfood             0.104000   1.800  0.140

10002420 10   Orange, peel                       0.104000   1.200  0.140

10003070 10   Pummelo                            0.103000   0.060  0.140

10003690 10   Tangerine                          0.104000   0.060  0.140

10003700 10   Tangerine, juice                   0.104000   2.300  0.140

11000070 11   Apple, fruit with peel             0.146000   1.000  0.150

11000080 11   Apple, peeled fruit                0.146000   0.150  0.150

11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.150

11000090 11   Apple, dried                       0.146000   0.180  0.150

11000091 11   Apple, dried-babyfood              0.146000   0.180  0.150

11000100 11   Apple, juice                       0.146000   0.030  0.150

11000101 11   Apple, juice-babyfood              0.146000   0.030  0.150

11000110 11   Apple, sauce                       0.146000   0.070  0.150

11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.150

11001290 11   Crabapple                          0.146000   1.000  0.150

11002100 11   Loquat                             0.239000   1.000  0.150

11002660 11   Pear                               0.239000   1.000  0.150

11002661 11   Pear-babyfood                      0.239000   1.000  0.150

11002670 11   Pear, dried                        0.239000   0.180  0.150

11002680 11   Pear, juice                        0.239000   0.030  0.150

11002681 11   Pear, juice-babyfood               0.239000   0.030  0.150

11003100 11   Quince                             0.239000   1.000  0.150

12000120 12   Apricot                            0.368000   1.000  0.100

12000121 12   Apricot-babyfood                   0.368000   1.000  0.100

12000130 12   Apricot, dried                     0.368000   6.000  0.100

12000140 12   Apricot, juice                     0.368000   1.000  0.100

12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.100

12000900 12   Cherry                             0.286000   1.000  0.100

12000901 12   Cherry-babyfood                    0.286000   1.000  0.100

12000910 12   Cherry, juice                      0.286000   1.500  0.100

12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.100

12002300 12   Nectarine                          0.368000   1.000  0.100

12002600 12   Peach                              0.368000   1.000  0.100

12002601 12   Peach-babyfood                     0.368000   1.000  0.100

12002610 12   Peach, dried                       0.368000   7.000  0.100

12002611 12   Peach, dried-babyfood              0.368000   7.000  0.100

12002620 12   Peach, juice                       0.368000   1.000  0.100

12002621 12   Peach, juice-babyfood              0.368000   1.000  0.100

12002850 12   Plum                               0.068000   1.000  0.100

12002851 12   Plum-babyfood                      0.068000   1.000  0.100

12002860 12   Plum, prune, fresh                 0.068000   1.000  0.100

12002861 12   Plum, prune, fresh-babyfood        0.068000   1.000  0.100

12002870 12   Plum, prune, dried                 0.068000   5.000  0.100

12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.100

12002880 12   Plum, prune, juice                 0.068000   1.400  0.100

12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.100

14000030 14   Almond                             0.023000   1.000  1.000

14000031 14   Almond-babyfood                    0.023000   1.000  1.000

14000040 14   Almond, oil                        0.023000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.023000   1.000  1.000

14000590 14   Brazil nut                         0.019000   1.000  1.000

14000680 14   Butternut                          0.019000   1.000  1.000

14000810 14   Cashew                             0.019000   1.000  1.000

14000920 14   Chestnut                           0.023000   1.000  1.000

14001550 14   Filbert                            0.019000   1.000  1.000

14001560 14   Filbert, oil                       0.019000   1.000  1.000

14001850 14   Hickory nut                        0.019000   1.000  1.000

14002130 14   Macadamia nut                      0.019000   1.000  1.000

14002690 14   Pecan                              0.019000   1.000  1.000

14002820 14   Pistachio                          0.023000   1.000  1.000

14003910 14   Walnut                             0.019000   1.000  1.000

Attachment 4:  DEEM-FCID( Chronic Exposure Estimates.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit\124871chronic.R98

                                                     Adjustment factor #2 used.

Analysis Date 08-04-2009/07:44:23     Residue file dated: 08-04-2009/07:41:30/8

Reference dose (RfD, Chronic) = .014 mg/kg bw/day

COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000256                 1.8%

U.S. Population (spring season)             0.000271                 1.9%

U.S. Population (summer season)             0.000275                 2.0%

U.S. Population (autumn season)             0.000239                 1.7%

U.S. Population (winter season)             0.000241                 1.7%

Northeast region                            0.000249                 1.8%

Midwest region                              0.000263                 1.9%

Southern region                             0.000231                 1.6%

Western region                              0.000297                 2.1%

Hispanics                                   0.000273                 1.9%

Non-hispanic whites                         0.000260                 1.9%

Non-hispanic blacks                         0.000219                 1.6%

Non-hisp/non-white/non-black                0.000271                 1.9%

All infants (< 1 year)                      0.000455                 3.3%

Nursing infants                             0.000192                 1.4%

Non-nursing infants                         0.000555                 4.0%

Children 1-6  yrs                           0.000366                 2.6%

Children 7-12 yrs                           0.000200                 1.4%

Females 13-19 (not preg or nursing)         0.000141                 1.0%

Females 20+ (not preg or nursing)           0.000205                 1.5%

Females 13-50 yrs                           0.000215                 1.5%

Females 13+ (preg/not nursing)              0.000198                 1.4%

Females 13+ (nursing)                       0.000230                 1.6%

Males 13-19 yrs                             0.000181                 1.3%

Males 20+ yrs                               0.000315                 2.3%

Seniors 55+                                 0.000205                 1.5%

Children 1-2 yrs                            0.000432                 3.1%

Children 3-5 yrs                            0.000351                 2.5%

Children 6-12 yrs                           0.000213                 1.5%

Youth 13-19 yrs                             0.000162                 1.2%

Adults 20-49 yrs                            0.000283                 2.0%

Adults 50+ yrs                              0.000213                 1.5%

Females 13-49 yrs                           0.000201                 1.4%

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

Attachment 5:  DEEM-FCID( Cancer Residue File.

Filename: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit\124871cancer.R98

Chemical: spirodiclofen

RfD(Chronic): .014 mg/kg bw/day  NOEL(Chronic): 1.38 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0149

Date created/last modified: 08-04-2009/07:42:18/8          Program ver. 2.03

Comment: no acute endpoint identified; 100x uncertainity factor for chronic

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95000200 O    Avocado                            0.110000   1.000  1.000

95000740 O    Canistel                           0.110000   1.000  1.000

95001750 O    Grape                              0.697000   1.000  0.070

95001760 O    Grape, juice                       0.697000   0.170  0.070

95001761 O    Grape, juice-babyfood              0.697000   0.170  0.070

95001770 O    Grape, leaves                      0.697000   1.000  0.070

95001780 O    Grape, raisin                      0.697000   4.300  0.070

95001790 O    Grape, wine and sherry             0.697000   1.000  0.070

95001880 O    Hop                               11.600000   1.000  0.920

95002150 O    Mango                              0.110000   1.000  1.000

95002151 O    Mango-babyfood                     0.110000   1.000  1.000

95002160 O    Mango, dried                       0.110000   1.000  1.000

95002170 O    Mango, juice                       0.110000   1.000  1.000

95002171 O    Mango, juice-babyfood              0.110000   1.000  1.000

95002450 O    Papaya                             0.110000   1.000  1.000

95002451 O    Papaya-babyfood                    0.110000   1.000  1.000

95002460 O    Papaya, dried                      0.110000   1.800  1.000

95002470 O    Papaya, juice                      0.110000   1.500  1.000

95003330 O    Sapote, Mamey                      0.110000   1.000  1.000

86010000 O    Water, direct, all sources         0.001670   1.000  1.000

86020000 O    Water, indirect, all sources       0.001670   1.000  1.000

21000440 M    Beef, meat                         0.000100   1.000  1.000

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000

21000460 M    Beef, meat byproducts              0.004000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.004000   1.000  1.000

21000470 M    Beef, fat                          0.000700   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.000700   1.000  1.000

21000480 M    Beef, kidney                       0.004000   1.000  1.000

21000490 M    Beef, liver                        0.000900   1.000  1.000

21000491 M    Beef, liver-babyfood               0.000900   1.000  1.000

23001690 M    Goat, meat                         0.000100   1.000  1.000

23001700 M    Goat, meat byproducts              0.004000   1.000  1.000

23001710 M    Goat, fat                          0.000700   1.000  1.000

23001720 M    Goat, kidney                       0.004000   1.000  1.000

23001730 M    Goat, liver                        0.000900   1.000  1.000

24001890 M    Horse, meat                        0.000100   1.000  1.000

26003390 M    Sheep, meat                        0.000100   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000

26003400 M    Sheep, meat byproducts             0.004000   1.000  1.000

26003410 M    Sheep, fat                         0.000700   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.000700   1.000  1.000

26003420 M    Sheep, kidney                      0.004000   1.000  1.000

26003430 M    Sheep, liver                       0.000900   1.000  1.000

27002220 D    Milk, fat                          0.005000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.005000   1.000  1.000

27012230 D    Milk, nonfat solids                0.000200   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000

27022240 D    Milk, water                        0.000200   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.000200   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.000200   1.000  1.000

10001060 10   Citrus citron                      0.104000   1.000  0.140

10001070 10   Citrus hybrids                     0.104000   0.060  0.140

10001080 10   Citrus, oil                        0.121000  69.000  0.140

10001800 10   Grapefruit                         0.103000   0.060  0.130

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130

10001970 10   Kumquat                            0.104000   0.060  0.140

10001990 10   Lemon                              0.121000   0.060  0.140

10002000 10   Lemon, juice                       0.121000   2.000  0.140

10002001 10   Lemon, juice-babyfood              0.121000   2.000  0.140

10002010 10   Lemon, peel                        0.121000   1.200  0.140

10002060 10   Lime                               0.121000   0.060  0.140

10002070 10   Lime, juice                        0.121000   2.000  0.140

10002071 10   Lime, juice-babyfood               0.121000   2.000  0.140

10002400 10   Orange                             0.104000   0.060  0.140

10002410 10   Orange, juice                      0.104000   1.800  0.140

10002411 10   Orange, juice-babyfood             0.104000   1.800  0.140

10002420 10   Orange, peel                       0.104000   1.200  0.140

10003070 10   Pummelo                            0.103000   0.060  0.140

10003690 10   Tangerine                          0.104000   0.060  0.140

10003700 10   Tangerine, juice                   0.104000   2.300  0.140

11000070 11   Apple, fruit with peel             0.146000   1.000  0.150

11000080 11   Apple, peeled fruit                0.146000   0.150  0.150

11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.150

11000090 11   Apple, dried                       0.146000   0.180  0.150

11000091 11   Apple, dried-babyfood              0.146000   0.180  0.150

11000100 11   Apple, juice                       0.146000   0.030  0.150

11000101 11   Apple, juice-babyfood              0.146000   0.030  0.150

11000110 11   Apple, sauce                       0.146000   0.070  0.150

11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.150

11001290 11   Crabapple                          0.146000   1.000  0.150

11002100 11   Loquat                             0.239000   1.000  0.150

11002660 11   Pear                               0.239000   1.000  0.150

11002661 11   Pear-babyfood                      0.239000   1.000  0.150

11002670 11   Pear, dried                        0.239000   0.180  0.150

11002680 11   Pear, juice                        0.239000   0.030  0.150

11002681 11   Pear, juice-babyfood               0.239000   0.030  0.150

11003100 11   Quince                             0.239000   1.000  0.150

12000120 12   Apricot                            0.368000   1.000  0.100

12000121 12   Apricot-babyfood                   0.368000   1.000  0.100

12000130 12   Apricot, dried                     0.368000   6.000  0.100

12000140 12   Apricot, juice                     0.368000   1.000  0.100

12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.100

12000900 12   Cherry                             0.286000   1.000  0.100

12000901 12   Cherry-babyfood                    0.286000   1.000  0.100

12000910 12   Cherry, juice                      0.286000   1.500  0.100

12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.100

12002300 12   Nectarine                          0.368000   1.000  0.100

12002600 12   Peach                              0.368000   1.000  0.100

12002601 12   Peach-babyfood                     0.368000   1.000  0.100

12002610 12   Peach, dried                       0.368000   7.000  0.100

12002611 12   Peach, dried-babyfood              0.368000   7.000  0.100

12002620 12   Peach, juice                       0.368000   1.000  0.100

12002621 12   Peach, juice-babyfood              0.368000   1.000  0.100

12002850 12   Plum                               0.068000   1.000  0.100

12002851 12   Plum-babyfood                      0.068000   1.000  0.100

12002860 12   Plum, prune, fresh                 0.068000   1.000  0.100

12002861 12   Plum, prune, fresh-babyfood        0.068000   1.000  0.100

12002870 12   Plum, prune, dried                 0.068000   5.000  0.100

12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.100

12002880 12   Plum, prune, juice                 0.068000   1.400  0.100

12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.100

14000030 14   Almond                             0.023000   1.000  1.000

14000031 14   Almond-babyfood                    0.023000   1.000  1.000

14000040 14   Almond, oil                        0.023000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.023000   1.000  1.000

14000590 14   Brazil nut                         0.019000   1.000  1.000

14000680 14   Butternut                          0.019000   1.000  1.000

14000810 14   Cashew                             0.019000   1.000  1.000

14000920 14   Chestnut                           0.023000   1.000  1.000

14001550 14   Filbert                            0.019000   1.000  1.000

14001560 14   Filbert, oil                       0.019000   1.000  1.000

14001850 14   Hickory nut                        0.019000   1.000  1.000

14002130 14   Macadamia nut                      0.019000   1.000  1.000

14002690 14   Pecan                              0.019000   1.000  1.000

14002820 14   Pistachio                          0.023000   1.000  1.000

14003910 14   Walnut                             0.019000   1.000  1.000

Attachment 6:  DEEM-FCID( Cancer Exposure Estimates.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit\124871cancer.R98

                                                     Adjustment factor #2 used.

Analysis Date 08-04-2009/07:44:45     Residue file dated: 08-04-2009/07:42:18/8

Q* = 0.0149

COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0149)

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

U.S. Population (total)                     0.000186         2.78E-06

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

Attachment 7:  DEEM-FCID( Critical Commodity Analysis for Cancer.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit\124871cancer.R98

                                                     Adjustment factor #2 used.

Analysis Date 08-04-2009/07:45:03     Residue file dated: 08-04-2009/07:42:18/8

Q* = 0.0149

COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

======================================================================== =======

                 Critical Commodity Contribution Analysis for

                            U.S. Population (total)

                 Total Exposure =.0001864 mg/kg bw/day

            Crop groups with total exposure contribution > 5%

              Foods/Foodforms with exposure contribution > 5%

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

Crop group                               -----------Exposure analysis----------

   Food                                     mg/kg   | % of Total| Lifetime Risk

      Foodform                           body wt/day|  Exposure |(Q*= .0149)

--------------------------------------   -----------|-----------|--------------

Crop Group = (O)  Other

   Hop (95001880):

        FoodForm N/S                       0.0000746    40.05%        1.11E-06

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0000203    10.87%        3.02E-07

   Water, indirect, all sources (86020000):

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   Orange, juice (10002410):

        FoodForm N/S                       0.0000307    16.45%        4.57E-07

--------------------------------------   -----------|-----------|--------------

  Total for crop group                     0.0000341    18.27%        5.07E-07

Crop Group = (11) Pome Fruits

  Total for crop group                     0.0000106     5.67%        1.57E-07

Total for crop groups listed above:        0.0001765    94.71%        2.63E-06

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

Spirodiclofen	Dietary Exposure and Risk Assessment	DP Number: D367559

Page   PAGE  1  of   NUMPAGES  21