[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Notices]
[Pages 55064-55065]
[FR Doc No: 2014-21939]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-71]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before October 6, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0331 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Brenda Robeson, ARM-210, Federal
Aviation Administration, Office of Rulemaking, 800 Independence Ave.
SW., Washington, DC 20591; email<EMAIL_ADDRESS>(202) 267-
4712.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on September 10, 2014.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2014-0331.
    Petitioner: PMI Global Services, Inc.
    Section of 14 CFR Affected: 14 CFR 91.211(b)(1)(ii).
    Description of Relief Sought: Petitioner requests relief from the
requirement that one pilot crewmember wear and use an oxygen mask while
at flight altitudes above flight level 410. The relief would enable
domestic and international 14 CFR part 91 operations of company
aircraft equipped with quick donning oxygen masks and automatic
emergency descent mode technology.
[FR Doc. 2014-21939 Filed 9-12-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49783-49784]
[FR Doc No: 2014-19938]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Revamping Microbiological Test Methods for Contact Lenses
Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA), the American Academy
of Ophthalmology (AAO), the American Academy of Optometry (AAOpt), the
American Optometric Association (AOA), and the Contact Lens Association
of Ophthalmologists, Inc. (CLAO), are cosponsoring a public workshop
entitled ``Revamping Microbiological Test Methods for Contact Lenses,
Products, and Accessories.'' The purpose of this workshop is to discuss
adequate testing of contact lens care products for disinfection
efficacy against emerging pathogens as well as common infectious
etiologies. Participants will explore the pros and cons of the various
proposals for disinfection efficacy testing and aid in developing
general recommendations. The workshop will assist in informing the
regulatory science for evaluating contact lenses and disinfection
efficacy of associated care products as well as improving test methods
to mitigate potential infections.

DATES: Date and Time: The public workshop will be held on September 12,
2014, from 8 a.m. to 5 p.m. Sign-in will open at 7:30 a.m.

ADDRESSES: Location: The public workshop will be held at FDA's White
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the
Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Contact Person: Jeffrey Brocious,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2252, Silver
Spring, MD 20993,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Registration: Registration is $250 for members of the AAO, AAOpt,
AOA, or CLAO; or $400 for non-members and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by September 5, 2014, at 4 p.m. EDT.
There will be no onsite registration on the day of the public workshop.
Early registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization.
    If you need special accommodations due to a disability, please
contact Ms. Susan Monahan at<EMAIL_ADDRESS>or<PHONE_NUMBER>
no later than August 28, 2014.
    To register for the public workshop, please visit http://www.clwkshop.org/. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone number. If there are any questions with registration, please
contact Ms. Cindy Groff at<EMAIL_ADDRESS>Registrants will
receive confirmation after they have been accepted. You will be
notified if you are on a waiting list.
    Food and beverages will be available for purchase by participants
during the workshop breaks. For more information on the workshop,
please see the FDA's Medical Devices News & Events--Workshops &
Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the
posted events list.)
    Streaming Webcast of the Public Workshop: The public workshop will

also be Webcast. Persons interested in viewing the Webcast must
register online by September 5, 2014. Early registration is recommended
because Webcast connections are limited. Organizations are requested to
register all participants, but to view using one connection per
location. Webcast participants will be sent technical system
requirements after registration and will be sent connection access
information after September 5, 2014. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcript will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Supplementary information:

I. Background

    To ensure that safe and effective contact lenses and associated
care products are introduced into the U.S. marketplace, FDA has issued
guidance documents, recognized standards that describe the appropriate
test methods, and held workshops. In 2009, FDA held a workshop entitled
``Microbiological Testing for Contact Lens Care Products'' that was
cosponsored by AAO, AAOpt, AOA, and CLAO (Ref. 1). Representatives from
industry, academia, professional organizations, and regulatory agencies
discussed variables to consider when developing disinfection efficacy
test methods against Acanthamoeba keratitis (AK) as well as current
contact lens disinfection tests and limitations.
    Although the 2009 workshop began gathering information, there has
been a persistent increase in the number of AK cases (Ref. 2). This
persistent rise in the number of AK cases has prompted concern about
the safety of contact lens care products. While most experts present at
a 2008 Ophthalmic Devices Advisory Panel meeting agreed that
Acanthamoeba should be added as a challenge organism to disinfection
efficacy testing methods, consensus has not been reached on the
appropriate method for performing this testing (Ref. 3).
    At this workshop, the concerning rise in the keratitis associated
with Acanthamoeba will be discussed as well as the emergence of other
pathogens in contact lens related keratitis. The progress made in the
development of Acanthamoeba test methods will be summarized. The goal
of the workshop is to determine uniform testing methods for
Acanthamoeba disinfection efficacy as well as to discuss methods for
conducting real-world simulated testing of contact lens care products.
The meeting will bring together scientists, clinicians, and industry
experts to discuss critical aspects of disinfection efficacy testing.
    The FDA/AAO/AAOpt/AOA/CLAO Workshop will provide FDA with an
important opportunity to interact with stakeholders and gain knowledge
and information on methods to test commonly used medical devices and
would assist the Agency in carrying out its mission to promote and
protect the public health.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not
limited to, the following as they relate to contact lenses and their
associated care products:
     Emerging infectious pathogens in contact lens related
keratitis;
     role of soil in disinfection efficacy testing; and
     Acanthamoeba disinfection efficacy test methods.

These topics will be presented by experts in the associated area with
more in-depth discussions of the given topics during panel sessions.

III. References

    The following references have been placed on display in the
Division of Dockets Management (see Transcripts) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses in this reference section, but FDA
is not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)

    1. Public workshop in 2009, ``Microbiological Testing for
Contact Lens Care Products,'' Federal Register notice, available at
http://www.gpo.gov/fdsys/pkg/FR-2008-12-16/pdf/E8-29741.pdf.
    2. Yoder, J.S. et al., ``Acanthamoeba Keratitis: The Persistence
of Cases Following a Multistate Outbreak,'' Ophthalmic Epidemiology,
vol. 19, pp. 221-225, 2012.
    3. Ophthalmic Devices Advisory Panel meeting (2008) minutes,
available at http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4363m1.pdf.

    Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19938 Filed 8-21-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Rules and Regulations]
[Pages 23489-23490]
[FR Doc No: 2011-10192]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51 and 52

[EPA-HQ-OAR-2004-0014, FRL-9299-3]
RIN 2060-AQ73

Prevention of Significant Deterioration (PSD) and Nonattainment
New Source Review (NSR): Reconsideration of Inclusion of Fugitive
Emissions; Interim Rule; Stay and Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of extension of comment period.

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SUMMARY: EPA is announcing an extension of the public comment period on
the interim rule titled, ``Prevention of Significant Deterioration
(PSD) and Nonattainment New Source Review (NSR): Reconsideration of
Inclusion of Fugitive Emissions; Interim Rule; Stay and Revisions.'' It
published in the Federal Register on March 30, 2011. EPA is extending
the comment period that originally closed on April 29, 2011, by an
additional 32 days. The comment period will now close on May 31, 2011.
EPA is extending the comment period because of a request we received,
which is contained in the docket for this rulemaking.

DATES: Comments. Comments must be received on or before May 31, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2004-0014, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Attention Docket ID No. EPA-HQ-OAR-2004-0014, U.S.
Environmental Protection Agency, EPA West (Air Docket), 1200
Pennsylvania Avenue, Northwest, Mailcode: 6102T, Washington, DC 20460.
Please include a total of 2 copies.
     Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), 1301 Constitution Avenue, Northwest, Room 3334,
Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2004-0014.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2004-0014. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Air Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Air Docket is (202) 566-
1742.

FOR FURTHER INFORMATION CONTACT: For general information, contact Peter
Keller, Air Quality Policy Division, U.S. EPA, Office of Air Quality
Planning and Standards (C504-03), Research Triangle Park, North
Carolina 27711, telephone number<PHONE_NUMBER>, facsimile number (919)
541-5509, electronic mail e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI

information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. Send or deliver
information identified as CBI only to the following address: Roberto
Morales, OAQPS Document Control Officer (C404-02), U.S. EPA, Research
Triangle Park, NC 27711, Attention Docket ID No. EPA-HQ-OAR-2004-0014.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

B. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this notice will also be available on the World Wide Web (WWW).
Following signature by the OAQPS Division Director, a copy of this
notice will be posted in the regulations and standards section of our
NSR home page located at http://www.epa.gov/nsr.

    Dated: April 22, 2011.
Mary Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2011-10192 Filed 4-26-11; 8:45 am]
BILLING CODE 6560-50-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:  		6 February 2012

SUBJECT:	Tolfenpyrad Acute and Chronic Aggregate Dietary Exposure and Risk Assessments

PC Code:  090111
DP Barcode:  D398817
Decision No.: 440578
Registration No.:  71711-31, 71711-GA
Petition No.:  0F7791
Regulatory Action:  Section 3
Assessment Type:  Single Chemical
Registration Case No.:  NA
TXR No.:  None
CAS No.:  129558-76-5
MRID Nos.:  None
40 CFR 180. none (first food use request)

FROM:	Michael A. Doherty, Ph.D., Senior Chemist
            Risk Assessment Branch II
            Health Effects Division (7509P)

THROUGH:	Amelia Acierto, Chemist
            Julie VanAlstine, Environmental Health Scientist
            Dietary Exposure Science Advisory Council (DESAC)
            Health Effects Division (7509P)

            Christina Swartz, Branch Chief
            Risk Assessment Branch II
            Health Effects Division (7509P)

TO:		Michael A. Doherty, Ph.D., Senior Chemist
            Risk Assessment Branch II
		Health Effects Division (7509P)

         Driss Benmhend/Mark Suarez (Team 13)
		Insecticide Branch
      Registration Division (7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID(TM) (v. 2.03).  This model uses food consumption data from the U.S. Department of Agriculture's (USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support a Section 3 registration request on the following fourteen crops or crop groups: potato; leafy vegetables, except Brassica; Brassica leafy vegetables; fruiting vegetables; cucurbit vegetables; citrus fruits; pome fruits; stone fruits; persimmon; pomegranate; grape; tree nuts (including pistachio); cotton; and tea.  A quantitative cancer assessment was not conducted.  Tolfenpyrad is classified as "not likely to be carcinogenic to humans;" therefore, there is no cancer risk associated with tolfenpyrad.

The acute assessment is a screening-level, highly conservative assessment.  Inputs to the analysis are tolerance-level residues for the above-listed foods and modeled estimates of residues in drinking water.  The acute assessment assumes that all crops with proposed uses are treated (i.e., 100% crop treated).  For the acute assessment, the highest estimated exposure at the 95[th] percentile is 0.076 mg/kg/day, which corresponds to 76% of the aPAD.  Typically HED has concerns when exposures exceed 100% of the acute or chronic population-adjusted dose (aPAD or cPAD).  Acute dietary risk estimates are below HED's level of concern for all population subgroups.

The chronic assessment is significantly refined.  Inputs to the chronic assessment include average residue levels from crop field trials; use of percent crop treated estimates for foods which were shown to have a high contribution to the overall dietary exposure; liberal translation of juice processing factors; and reduction of residues from removal of head lettuce and cabbage wrapper leaves.  Although refined, the chronic dietary analysis is not expected to underestimate dietary exposures.  The highest chronic dietary exposure estimate is 0.0041 mg/kg/day, which corresponds to 69% of the cPAD.  As with the acute assessment, the chronic estimates are below HED's level of concern for all population subgroups.

There are no dietary exposure considerations that would preclude granting the requested uses of tolfenpyrad.

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:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999).

This is the first food-use assessment for tolfenpyrad.

II.	Residue Information

The Agency has received a petition requesting use of tolfenpyrad on a large number of crops.  This is the first food-use petition for this chemical.  As such, there are no tolerance entries for tolfenpyrad in the Code of Federal Regulation (CFR) at this time.

The toxicological and residue chemistry databases for tolfenpyrad have been examined to determine residue definitions for tolerance-setting and risk-assessment purposes.  The residue definitions are summarized in Table 1 and are in keeping with the recommendations of the Residues of Concern Knowledgebase Subcommittee (ROCKS; D395592, 18 January 2012).

Table 1.  Residue Definitions for Tolfenpyrad.
Matrix
Risk Assessment
Tolerance Expression
Plants
Primary Crop
Tolfenpyrad + PT-CA[1] (root crops only)
Tolfenpyrad

Rotational Crop
--[2]
--
Livestock
Ruminant
Tolfenpyrad + PT-CA + OH-PT-CA[3]
Tolfenpyrad + PT-CA

Poultry
Tolfenpyrad + PT-CA + PCA
Tolfenpyrad + PT-CA
Drinking Water
Tolfenpyrad + PT-CA + PCA + PAM + PT(A)-4-OH
Not Applicable
[1] 	The metabolite abbreviations used here (i.e. "PCA" and "PAM") are specific for the metabolites depicted in the residue chemistry summary document (M. Doherty, D384995, 12 April 2012).  These abbreviations are not intended to represent other chemicals with similar, but not identical, structures using similar abbreviations.
[2] 	Residues of concern in rotational crops are not expected as a result of the proposed use patterns.
[3] 	OH-PT-CA should be limited to ruminant liver, kidney, and other meat byproducts.

The crop field trials and cattle feeding study did not measure all of the residues of concern for risk assessment purposes.  Therefore, residues of PT-CA in root crops and residues of OH-PT-CA in ruminant liver, kidney, and other meat byproducts are accounted for by using ratios of these residues relative to the measured residues (parent in crops, parent + PT-CA in cattle) from the crop and livestock metabolism studies.  In the crop metabolism studies, radish root is representative of root crops.  Residues of tolfenpyrad in radish root accounted for 54% of the total radioactive residue (TRR); residues of PT-CA in this commodity accounted for 22% of the TRR.  Therefore, the relative ratio of PT-CA to tolfenpyrad is 0.41.  A factor of 1.41 has been used in the input files (Attachments 1 and 2) to convert tolfenpyrad to tolfenpyrad + PT-CA for potato commodities (the only root crop in the current request).  Similarly, in the goat metabolism study, tolfenpyrad + PT-CA account for 59% TRR and 63% TRR in liver and kidney, respectively.  The metabolite OH-PT-CA made up 28% TRR and 19% TRR in these tissues, giving ratios of 0.47 in liver and 0.30 in kidney.  A factor of 1.47, incorporating the greater of these two ratios, was used for all livestock liver, kidney, and meat-byproduct entries in the assessments.

Acute Assessment:  With the exception of juices, the acute assessment assumes tolerance-level residues in all crops with requested uses (i.e., 100% crop treated).  Also with the exception of juices, default processing factors from DEEM 7.81 were used for processed commodities when empirical data were not available.  For juices, a processing factor of 0.03 was used unless a lower empirical value was available for a particular juice.  The factor of 0.03 is from the processing of grapes into grape juice and is the maximum juice factor in the tolfenpyrad database.  Even with this refinement, the acute assessment should be considered a screening-level assessment and very conservative with respect to protecting human health.

Chronic Assessment:  While still protective of human health, the chronic assessment incorporates three refinements that are not used in the acute assessment.  First, the chronic assessment uses average values (Table 2) from crop field trials.  For crop group commodities, a standard procedure was used to parse residue data from representative crops to other crops in the crop group.  Second, the chronic assessment incorporates new-use percent crop treated estimates (PCTn) for oranges, apples, table grapes, and spinach (Table 3).  These estimates were provided by the Biological and Economic Analysis Division (S. Haddad, D393941, 6 February 2012).  Third, the chronic assessment includes a factor of 0.08 to reflect the reduction in residues for cabbage and head lettuce when the wrapper leaves are removed prior to marketing and consumption.  The chronic assessment uses the same processing factors as those described for the acute assessment.

Table 2.  Summary of Crop Field Trial Residue Data.
Commodity
                                 Residue, ppm
Translated to

                                   Tolerance
                                     Mean

Potato (Input file includes factor of 1.41 to account for PT-CA metabolite)
  Potato Tuber
0.01
0.01
--
  Potato Processed Commodities (Processing Factor = 1)
--
0.01
--
Leafy Vegetables Crop Group 4
  Leaf Lettuce
30
5.45
--
  Head Lettuce (w/ wrapper leaves)
30
1.59
--
  Celery
30
2.71
Cardoon, Celtuce, Florence Fennel, Rhubarb, Swiss Chard
  Spinach
30
9.88

Head and Stem Brassica Vegetables Crop Subgroup 5A
  Cauliflower
5
0.199
Broccoli, Chinese Broccoli, Chinese Mustard Cabbage
  Cabbage w/ wrapper leaves
5
1.43
Brussels Sprouts, Chinese Napa Cabbage, Kohlrabi
Leafy Brassica Vegetables Crop Subgroup 5B
  Mustard Greens
40
8.62
Broccoli Raab, Bok Choy, Collards, Kale, Rape Greens, Turnip Greens
Fruiting Vegetables Crop Group 8-10
  Tomato
0.7
0.124
Groundcherry, Pepino, Tomatillo, Tree Tomato
  Tomato Puree (Processing Factor = 0.3)
--
0.124
--
  Tomato Paste (Processing Factor = 1.02)
--
0.124
--
  Bell Pepper
0.7
0.09
Eggplant
  Non-bell Pepper
0.7
0.233
Okra
Cucurbit Vegetables Crop Group 9
  Cucumber
0.7
0.12
Waxgourd, Balsam Pear, Bitter Melon
  Cantaloupe
0.7
0.23
Citron Melon, Watermelon, Casaba, Honeydew Melon
  Summer Squash
0.7
0.047
Pumpkin, Winter Squash, Chayote
Citrus Fruits Crop Group 10-10
  Orange
1.5
0.409
Citrus Citron, Tangerine, Kumquat
  Grapefruit
1.5
0.217
Pummelo
  Lemon
1.5
0.437
Lime
  Orange Juice (Processing Factor = 0.02)
--
See
Above
Grapefruit Juice, Lemon Juice, Lime Juice, Tangerine Juice
  Citrus Oil (Processing Factor = 82)
70
0.409
--
Pome Fruits Crop Group 11-10
  Apple
0.7
0.206
Crabapple
  Apple Juice (Processing Factor = <0.01)
--
0.206
Processing factor applied to pear juice
  Pear
0.7
0.199
Loquat, Quince
Stone Fruit Crop Group 12
  Sweet Cherry
2
0.551
Persimmon, Pomegranate
  Peach
2
0.362
Apricot, Nectarine
  Plum
2
0.402
--
  Plum, Dried (Processing Factor = 2.9)
3
0.402
--
Tree Nuts Crop Group 14
  Almond Nutmeat
0.05
0.013
Chestnut, Pistachio
  Pecan Nutmeat
0.05
0.01
Brazil Nut, Butternut, Cashew, Filbert, Hickory Nut, Macadamia Nut, Walnut
Other
  Cotton, Undelinted Seed
0.7
0.172
--
  Cotton, refined oil (Processing Factor = 0.05)
--
0.172
--
  Grape
2
0.53
--
  Grape Juice (Processing Factor = 0.03)
--
0.53
Processing factor applied to all juices not otherwise listed.
  Grape, Raisins (Processing Factor = 3.7)
6
0.53
--
  Tea
30
7.06
--
Livestock (Cattle, Horses, Goats, and Sheep; Input file includes factor of 1.47 to account for OH-PT-CA metabolite in kidney, liver, and meat byproducts)
  Meat
0.01
--
--
  Fat
0.01
--
--
  Kidney
0.35
--
--
  Liver
0.35
--
--
  Meat Byproducts
0.35
--
--
  Milk
0.03
--
--

Table 3. PCTn for Tolfenpyrad Based on Insecticide Market Leaders.  From S. Haddad, D393941, 6 February 2012
Crop
Year
Market Leader
                                    Percent
                                     Crop
                                    Treated
                             PCTn for Tolfenpyrad*

Chronic (Avg.)
Acute (Max.)
Oranges
2009
Petroleum Distillate
                                      62%
                                      40
                                      60

2005
Spinosad
                                      32%

2003
S-methoprene
                                      17%

Apples
2009
Carbaryl
                                      51%
                                      60
                                      65

2007
Azinphos-methyl
                                      62%

2005
Azinphos-methyl
                                      63%

Table Grapes
2010

Proprietary

                                  Proprietary
                                      65
                                      90

2009

2008

2007

2006

2005

Spinach
2010
Permethrin
                                      53%
                                      50
                                      55

2006
Spinosad
                                      47%

2004
Spinosad
                                      49%

* all numbers rounded
Source:  USDA NASS Agricultural Chemical Usage - Fruit Summary (2003, 2005, 2007, 2009), Vegetable Summary (2004, 2006, 2010)

  Drinking Water Data

The estimated drinking water concentrations (EDWCs) used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: "Drinking Water Exposure Assessment for Proposed New Uses of Tolfenpyrad on a Variety of Agricultural Crops, Nurseries, and Christmas Trees" (L. Liu, D383822, 23 January 2012) and incorporated directly into this dietary assessment.  Water residues were incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."

The drinking water assessment notes that based on the submitted environmental fate data and reported physical-chemical properties, tolfenpyrad and its transformation products are expected to moderately degrade in the environment.  In soil, tolfenpyrad is expected to be essentially immobile; however, the degradates PCA and PT-CA are expected to be highly mobile.  A total residue approach was used to model residues in drinking water, with the residues of concern being PCA, PT-CA, PT(A)-4OH, and PAM.

Tolfenpyrad was modeled in this assessment as stable to metabolism and degradation because only limited studies were submitted by the registrant.  As a result, the metabolic half-lives used in modeling were multiplied by 3.  If additional metabolism studies become available, EECs could be lowered.  Assessment modeling relied on maximum labeled use patterns and a default national percent cropped area value (87%).  Where actual use patterns are less than the labeled maximum and location-specific PCAs are less than assumed in this assessment, actual environmental exposures may be lower.

Drinking water exposure estimates for the proposed uses of tolfenpyrad are represented by the use pattern of maximum tolfenpyrad exposure, nurseries and Christmas trees (Table 4).  Maximum acute, chronic, and cancer EDWCs in surface water are 26.9, 12.2, and 4.8 ug/L, respectively.  The maximum exposure estimate for ground water is 11 ug/L.  Monitoring and drinking water treatment data on tolfenpyrad are not available.  The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/.

Table 4.  Tolfenpyrad EDWCs in Surface Water and Ground Water for Use in Dietary Risk Assessment Based on the Use Pattern of Maximum Exposure, Nurseries and Christmas Trees. [*]
Use (maximum rate)
Source
                                Cropped Area, %
                     1-in-10-year Peak (Acute) Conc., ppb
                 1-in-10-year Annual Mean (Chronic) Conc., ppb
                   30-year Daily Average (Cancer) Conc., ppb
Ornamental plants and Christmas trees
(2.72 lbs a.i./A/year)
Surface water
                                      87
                                     26.9
                                     12.2
                                      4.8
Ornamental plants and Christmas trees
(2.72 lbs a.i./A/year)
Ground water
                                      N/A
                                     11.0
[*]	EDWCs were calculated based on total residues of concern (a summation of tolfenpyrad, PAM, PT-CA, PCA and PT(A)-4OH) and a percent cropped area of 87%.

IV.	DEEM-FCID(TM) Program and Consumption Information

Tolfenpyrad acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID(TM), Version 2.03 which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals (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" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., 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 (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake 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.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

A variety of toxic effects were noted in the toxicology database for tolfenpyrad; however, the most consistent finding across species and studies was effects on body weight and body weight gain.  Decreases in body weight and/or body weight gain were observed in adults of all species (rat, mice, rabbit, and dog) in the majority of the subchronic oral and dermal toxicity studies, and all chronic toxicity studies.

The toxicological database is complete for the purpose of FQPA assessment. Additionally, there are no concerns for increased quantitative and qualitative susceptibility or residual uncertainties for pre-and postnatal toxicity.  Although increased qualitative susceptibility was seen in the young in the developmental immunotoxicity study (DIT) in rats, considering the overall toxicity profile and the doses and endpoints selected for risk assessment the concern for the effects observed is low.  Furthermore, there is no concern for neurotoxicity, and a developmental neurotoxicity study (DNT) is not required at this time.  HED recommends that the 10x FQPA safety factor be reduced to 1x.

The risk assessment team has reviewed the available data and has selected the doses and endpoints for risk assessment summarized in Table 5.

Table 5.  Summary of Toxicological Doses and Endpoints for Tolfenpyrad for Use in Dietary Human Health Risk Assessments.
Exposure/
Scenario
                              Point of Departure
                       Uncertainty/ FQPA Safety Factors
                RfD, PAD, Level of Concern for Risk Assessment
                        Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)
NOAEL= 10 mg/kg/day
UFA= 10 x
UFH=10 x
FQPA SF=1x
Acute RfD = 0.1  mg/kg/day

aPAD = 0.1  mg/kg/day
LOAEL=20 mg/kg/day from an acute neurotoxicity study in rats, based on decreased body weight body weight gain and food consumption.
Chronic Dietary (All Populations)
NOAEL= 0.6 mg/kg/day
UFA= 10 x
UFH=10 x
FQPA SF=1x
Chronic RfD = 0.006
mg/kg/day

cPAD = 0.006 mg/kg/day
 LOAEL = 1.5 mg/kg/day from a combined chronic/carcinogenicity in rats, based on decreased body weight, body weight gain, and food consumption of females, gross changes in the Harderian glands of males, and histopathological changes in the liver, kidney, and mesenteric lymph nodes of females and the kidney of males.
Cancer
Classification:  "Not likely to be Carcinogenic to Humans" based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.
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.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population-adjusted dose (a = acute, c = chronic).  RfD = reference dose.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(TM) analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 6 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Table 6.  Summary of Acute and Chronic Dietary Exposure Analyses for Tolfenpyrad.
Population Subgroup
                           Acute (95[th] Percentile)
                                    Chronic
                                    Cancer

                        Estimated Exposure (mg/kg/day)
                            Estimated Risk, % aPAD
                        Estimated Exposure (mg/kg/day)
                            Estimated Risk, % cPAD

                             Exposure (mg/kg/day)
                                Estimated Risk
U.S. Population
0.0618
62
0.00169
28
                                Not Applicable
All infants
0.0397
40
0.00309
52

Children 1-2 yrs
0.0727
73
0.00413
69

Children 3-5 yrs
0.0757
76
0.00328
55

Children 6-12 yrs
0.0637
64
0.00190
32

Youth 13-19 yrs
0.0559
56
0.00130
22

Adults 20-49 yrs
0.0605
61
0.00133
22

Adults 50+ yrs
0.0612
61
0.00173
29

Females 13-49 yrs
0.0648
65
0.00139
23

Entries with the highest acute and chronic risk estimates are bolded.

Acute and chronic risk estimates are below HED's level of concern for all population subgroups, including those of infants and children.

 VII.	Characterization of Inputs/Outputs

 For the acute assessment, the inputs to the analysis can be characterized as highly health protective.  While the application of the juice processing factor from grapes to other juices provides some refinement relative to a strict screening-level assessment, the conservatism in the other input parameters results in exposure estimates that are likely to overestimate actual dietary exposure.

 As previously noted, the chronic assessment includes significant refinements.  Nevertheless, the overall chronic exposure estimates still retain a rather high level of conservatism due to the source and scope of the refinements.  The average residue values are from field trials which are designed to produce worst-case residue levels (maximum application rate, shortest PHI).  The residue levels make no allowance for lower applications rate, longer PHI, or dissipation of residues during storage and transportation to market.  It is quite likely that monitoring data, which take these issues into account, would show significantly lower residues than those used in this assessment.  Furthermore, the use of percent of crop treated estimates was limited to only a few crops and, in the case of grapes, to only a particular type (table grapes).  For all other crops, it was assumed that 100% of the planted acreage would be treated  -  a situation which is highly unlikely.  Overall, the chronic risk estimates are likely to be overestimates of actual chronic dietary risk.

 VIII.	Conclusions

 Based on the results of these analyses, there are no dietary exposure considerations that would preclude granting the requested uses of tolfenpyrad.

 IX.	List of Attachments

Attachment 1.	Summary of Inputs for the Acute Dietary Risk Assessment for Tolfenpyrad.
Attachment 2.	Summary of Inputs for the Chronic Dietary Risk Assessment for Tolfenpyrad.
Attachment 3.	Summary of the Acute Dietary Analysis Results for Tolfenpyrad.
Attachment 4.	Summary of the Chronic Dietary Analysis Results for Tolfenpyrad.
Attachment 5.	Percent Crop Treated Memorandum from the Biological and Economic Analysis Division.

Attachment 1.  Summary of inputs for the acute dietary risk assessment for tolfenpyrad.

Filename: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\!DEEM Runs\Tolfenpyrad\090111 Tolfenpyrad Acute Tol Juice PF 27ppb .R98
Chemical: 090111 Tolfenpyrad
RfD(Chronic): .006 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .1 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 02-16-2012/11:56:35/8          Program ver. 2.03
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2
-------- ---- -------------------------------  ----------  ------ ------  -------
01032960 1C   Potato, chips                      0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032970 1C   Potato, dry (granules/ flakes)     0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032971 1C   Potato, dry (granules/ flakes)-b   0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032980 1C   Potato, flour                      0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032981 1C   Potato, flour-babyfood             0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032990 1C   Potato, tuber, w/peel              0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032991 1C   Potato, tuber, w/peel-babyfood     0.010000   1.410  1.000  Factor 1 to account for PT-CA
01033000 1C   Potato, tuber, w/o peel            0.010000   1.410  1.000  Factor 1 to account for PT-CA
01033001 1C   Potato, tuber, w/o peel-babyfood   0.010000   1.410  1.000  Factor 1 to account for PT-CA
04012040 4A   Lettuce, head                     30.000000   1.000  1.000
04012050 4A   Lettuce, leaf                     30.000000   1.000  1.000
04013550 4A   Spinach                           30.000000   1.000  1.000
04013551 4A   Spinach-babyfood                  30.000000   1.000  1.000
04020760 4B   Cardoon                           30.000000   1.000  1.000
04020850 4B   Celery                            30.000000   1.000  1.000
04020851 4B   Celery-babyfood                   30.000000   1.000  1.000
04020860 4B   Celery, juice                     30.000000   0.030  1.000
04020870 4B   Celtuce                           30.000000   1.000  1.000
04021520 4B   Fennel, Florence                  30.000000   1.000  1.000
04023220 4B   Rhubarb                           30.000000   1.000  1.000
04023670 4B   Swiss chard                       30.000000   1.000  1.000
05010610 5A   Broccoli                           5.000000   1.000  1.000
05010611 5A   Broccoli-babyfood                  5.000000   1.000  1.000
05010620 5A   Broccoli, Chinese                  5.000000   1.000  1.000
05010640 5A   Brussels sprouts                   5.000000   1.000  1.000
05010690 5A   Cabbage                            5.000000   1.000  1.000
05010710 5A   Cabbage, Chinese, napa             5.000000   1.000  1.000
05010720 5A   Cabbage, Chinese, mustard          5.000000   1.000  1.000
05010830 5A   Cauliflower                        5.000000   1.000  1.000
05011960 5A   Kohlrabi                           5.000000   1.000  1.000
05020630 5B   Broccoli raab                     40.000000   1.000  1.000
05020700 5B   Cabbage, Chinese, bok choy        40.000000   1.000  1.000
05021170 5B   Collards                          40.000000   1.000  1.000
05021940 5B   Kale                              40.000000   1.000  1.000
05022290 5B   Mustard greens                    40.000000   1.000  1.000
05023180 5B   Rape greens                       40.000000   1.000  1.000
05023890 5B   Turnip, greens                    40.000000   1.000  1.000
08001480 8    Eggplant                           0.700000   1.000  1.000
08002340 8    Okra                               0.700000   1.000  1.000
08002700 8    Pepper, bell                       0.700000   1.000  1.000
08002701 8    Pepper, bell-babyfood              0.700000   1.000  1.000
08002710 8    Pepper, bell, dried                0.700000   1.000  1.000
08002711 8    Pepper, bell, dried-babyfood       0.700000   1.000  1.000
08002720 8    Pepper, nonbell                    0.700000   1.000  1.000
08002721 8    Pepper, nonbell-babyfood           0.700000   1.000  1.000
08002730 8    Pepper, nonbell, dried             0.700000   1.000  1.000
08003740 8    Tomatillo                          0.700000   1.000  1.000
08003750 8    Tomato                             0.700000   1.000  1.000
08003751 8    Tomato-babyfood                    0.700000   1.000  1.000
08003760 8    Tomato, paste                      0.700000   1.020  1.000
08003761 8    Tomato, paste-babyfood             0.700000   1.020  1.000
08003770 8    Tomato, puree                      0.700000   0.300  1.000
08003771 8    Tomato, puree-babyfood             0.700000   0.300  1.000
08003780 8    Tomato, dried                      0.700000  14.300  1.000
08003781 8    Tomato, dried-babyfood             0.700000  14.300  1.000
08003790 8    Tomato, juice                      0.700000   0.030  1.000
09010750 9A   Cantaloupe                         0.700000   1.000  1.000
09010800 9A   Casaba                             0.700000   1.000  1.000
09011870 9A   Honeydew melon                     0.700000   1.000  1.000
09013990 9A   Watermelon                         0.700000   1.000  1.000
09014000 9A   Watermelon, juice                  0.700000   0.030  1.000
09020210 9B   Balsam pear                        0.700000   1.000  1.000
09020880 9B   Chayote, fruit                     0.700000   1.000  1.000
09021020 9B   Chinese waxgourd                   0.700000   1.000  1.000
09021350 9B   Cucumber                           0.700000   1.000  1.000
09023080 9B   Pumpkin                            0.700000   1.000  1.000
09023090 9B   Pumpkin, seed                      0.700000   1.000  1.000
09023560 9B   Squash, summer                     0.700000   1.000  1.000
09023561 9B   Squash, summer-babyfood            0.700000   1.000  1.000
09023570 9B   Squash, winter                     0.700000   1.000  1.000
09023571 9B   Squash, winter-babyfood            0.700000   1.000  1.000
10001060 10   Citrus citron                      1.500000   1.000  1.000
10001070 10   Citrus hybrids                     1.500000   1.000  1.000
10001080 10   Citrus, oil                       70.000000   1.000  1.000
10001800 10   Grapefruit                         1.500000   1.000  1.000
10001810 10   Grapefruit, juice                  1.500000   0.020  1.000
10001970 10   Kumquat                            1.500000   1.000  1.000
10001990 10   Lemon                              1.500000   1.000  1.000
10002000 10   Lemon, juice                       1.500000   0.020  1.000
10002001 10   Lemon, juice-babyfood              1.500000   0.020  1.000
10002010 10   Lemon, peel                        1.500000   1.000  1.000
10002060 10   Lime                               1.500000   1.000  1.000
10002070 10   Lime, juice                        1.500000   0.020  1.000
10002071 10   Lime, juice-babyfood               1.500000   0.020  1.000
10002400 10   Orange                             1.500000   1.000  1.000
10002410 10   Orange, juice                      1.500000   0.020  1.000
10002411 10   Orange, juice-babyfood             1.500000   0.020  1.000
10002420 10   Orange, peel                       1.500000   1.000  1.000
10003070 10   Pummelo                            1.500000   1.000  1.000
10003690 10   Tangerine                          1.500000   1.000  1.000
10003700 10   Tangerine, juice                   1.500000   0.020  1.000
11000070 11   Apple, fruit with peel             0.700000   1.000  1.000
11000080 11   Apple, peeled fruit                0.700000   1.000  1.000
11000081 11   Apple, peeled fruit-babyfood       0.700000   1.000  1.000
11000090 11   Apple, dried                       0.700000   8.000  1.000
11000091 11   Apple, dried-babyfood              0.700000   8.000  1.000
11000100 11   Apple, juice                       0.700000   0.010  1.000
11000101 11   Apple, juice-babyfood              0.700000   0.010  1.000
11000110 11   Apple, sauce                       0.700000   1.000  1.000
11000111 11   Apple, sauce-babyfood              0.700000   1.000  1.000
11001290 11   Crabapple                          0.700000   1.000  1.000
11002100 11   Loquat                             0.700000   1.000  1.000
11002660 11   Pear                               0.700000   1.000  1.000
11002661 11   Pear-babyfood                      0.700000   1.000  1.000
11002670 11   Pear, dried                        0.700000   6.250  1.000
11002680 11   Pear, juice                        0.700000   0.010  1.000
11002681 11   Pear, juice-babyfood               0.700000   0.010  1.000
11003100 11   Quince                             0.700000   1.000  1.000
12000120 12   Apricot                            2.000000   1.000  1.000
12000121 12   Apricot-babyfood                   2.000000   1.000  1.000
12000130 12   Apricot, dried                     2.000000   6.000  1.000
12000140 12   Apricot, juice                     2.000000   0.030  1.000
12000141 12   Apricot, juice-babyfood            2.000000   0.030  1.000
12000900 12   Cherry                             2.000000   1.000  1.000
12000901 12   Cherry-babyfood                    2.000000   1.000  1.000
12000910 12   Cherry, juice                      2.000000   0.030  1.000
12000911 12   Cherry, juice-babyfood             2.000000   0.030  1.000
12002300 12   Nectarine                          2.000000   1.000  1.000
12002600 12   Peach                              2.000000   1.000  1.000
12002601 12   Peach-babyfood                     2.000000   1.000  1.000
12002610 12   Peach, dried                       2.000000   7.000  1.000
12002611 12   Peach, dried-babyfood              2.000000   7.000  1.000
12002620 12   Peach, juice                       2.000000   0.030  1.000
12002621 12   Peach, juice-babyfood              2.000000   0.030  1.000
12002850 12   Plum                               2.000000   1.000  1.000
12002851 12   Plum-babyfood                      2.000000   1.000  1.000
12002860 12   Plum, prune, fresh                 2.000000   1.000  1.000
12002861 12   Plum, prune, fresh-babyfood        2.000000   1.000  1.000
12002870 12   Plum, prune, dried                 3.000000   1.000  1.000
12002871 12   Plum, prune, dried-babyfood        3.000000   1.000  1.000
12002880 12   Plum, prune, juice                 2.000000   0.030  1.000
12002881 12   Plum, prune, juice-babyfood        2.000000   0.030  1.000
14000030 14   Almond                             0.050000   1.000  1.000
14000031 14   Almond-babyfood                    0.050000   1.000  1.000
14000040 14   Almond, oil                        0.050000   1.000  1.000
14000041 14   Almond, oil-babyfood               0.050000   1.000  1.000
14000590 14   Brazil nut                         0.050000   1.000  1.000
14000680 14   Butternut                          0.050000   1.000  1.000
14000810 14   Cashew                             0.050000   1.000  1.000
14000920 14   Chestnut                           0.050000   1.000  1.000
14001550 14   Filbert                            0.050000   1.000  1.000
14001560 14   Filbert, oil                       0.050000   1.000  1.000
14001850 14   Hickory nut                        0.050000   1.000  1.000
14002130 14   Macadamia nut                      0.050000   1.000  1.000
14002690 14   Pecan                              0.050000   1.000  1.000
14002820 14   Pistachio                          0.050000   1.000  1.000
14003910 14   Walnut                             0.050000   1.000  1.000
21000440 M    Beef, meat                         0.010000   1.000  1.000
21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000
21000450 M    Beef, meat, dried                  0.010000   1.920  1.000
21000460 M    Beef, meat byproducts              0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000461 M    Beef, meat byproducts-babyfood     0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000470 M    Beef, fat                          0.010000   1.000  1.000
21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000
21000480 M    Beef, kidney                       0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000490 M    Beef, liver                        0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000491 M    Beef, liver-babyfood               0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
23001690 M    Goat, meat                         0.010000   1.000  1.000
23001700 M    Goat, meat byproducts              0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
23001710 M    Goat, fat                          0.010000   1.000  1.000
23001720 M    Goat, kidney                       0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
23001730 M    Goat, liver                        0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
24001890 M    Horse, meat                        0.010000   1.000  1.000
26003390 M    Sheep, meat                        0.010000   1.000  1.000
26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
26003400 M    Sheep, meat byproducts             0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
26003410 M    Sheep, fat                         0.010000   1.000  1.000
26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000
26003420 M    Sheep, kidney                      0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
26003430 M    Sheep, liver                       0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
27002220 D    Milk, fat                          0.030000   1.000  1.000
27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000
27012230 D    Milk, nonfat solids                0.030000   1.000  1.000
27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
27022240 D    Milk, water                        0.030000   1.000  1.000
27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000
27032251 D    Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000
29003120 M    Rabbit, meat                       0.010000   1.000  1.000
86010000 O    Water, direct, all sources         0.026900   1.000  1.000
86020000 O    Water, indirect, all sources       0.026900   1.000  1.000
95001280 O    Cottonseed, oil                    0.700000   0.050  1.000
95001281 O    Cottonseed, oil-babyfood           0.700000   0.050  1.000
95001750 O    Grape                              2.000000   1.000  1.000
95001760 O    Grape, juice                       2.000000   0.030  1.000
95001761 O    Grape, juice-babyfood              2.000000   0.030  1.000
95001770 O    Grape, leaves                      2.000000   1.000  1.000
95001780 O    Grape, raisin                      6.000000   1.000  1.000
95001790 O    Grape, wine and sherry             2.000000   0.030  1.000
95002770 O    Persimmon                          2.000000   1.000  1.000  From Stone Fruit
95002890 O    Pomegranate                        2.000000   1.000  1.000  From Stone Fruit
95003720 O    Tea, dried                        30.000000   1.000  1.000
95003730 O    Tea, instant                      30.000000   1.000  1.000
95003800 O    Tomato, Tree                       0.700000   1.000  1.000

Attachment 2.  Summary of inputs for the chronic dietary risk assessment for tolfenpyrad.

Filename: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\!DEEM Runs\Tolfenpyrad\090111 Tolfenpyrad Chronic Average Juice PF 12ppb PCTn.R98
Chemical: 090111 Tolfenpyrad
RfD(Chronic): .006 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .1 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 02-16-2012/11:57:03/8          Program ver. 2.03
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2
-------- ---- -------------------------------  ----------  ------ ------  -------
01032960 1C   Potato, chips                      0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032970 1C   Potato, dry (granules/ flakes)     0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032971 1C   Potato, dry (granules/ flakes)-b   0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032980 1C   Potato, flour                      0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032981 1C   Potato, flour-babyfood             0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032990 1C   Potato, tuber, w/peel              0.010000   1.410  1.000  Factor 1 to account for PT-CA
01032991 1C   Potato, tuber, w/peel-babyfood     0.010000   1.410  1.000  Factor 1 to account for PT-CA
01033000 1C   Potato, tuber, w/o peel            0.010000   1.410  1.000  Factor 1 to account for PT-CA
01033001 1C   Potato, tuber, w/o peel-babyfood   0.010000   1.410  1.000  Factor 1 to account for PT-CA
04012040 4A   Lettuce, head                      1.590000   0.080  1.000  Factor for removal of wrapper leaves
04012050 4A   Lettuce, leaf                      5.450000   1.000  1.000
04013550 4A   Spinach                            9.880000   1.000  0.500
04013551 4A   Spinach-babyfood                   9.880000   1.000  0.500
04020760 4B   Cardoon                            2.710000   1.000  1.000
04020850 4B   Celery                             2.710000   1.000  1.000
04020851 4B   Celery-babyfood                    2.710000   1.000  1.000
04020860 4B   Celery, juice                      2.710000   0.030  1.000
04020870 4B   Celtuce                            2.710000   1.000  1.000
04021520 4B   Fennel, Florence                   2.710000   1.000  1.000
04023220 4B   Rhubarb                            2.710000   1.000  1.000
04023670 4B   Swiss chard                        2.710000   1.000  1.000
05010610 5A   Broccoli                           0.199000   1.000  1.000
05010611 5A   Broccoli-babyfood                  0.199000   1.000  1.000
05010620 5A   Broccoli, Chinese                  0.199000   1.000  1.000
05010640 5A   Brussels sprouts                   1.430000   1.000  1.000
05010690 5A   Cabbage                            1.430000   0.080  1.000  Factor for removal of wrapper leaves
05010710 5A   Cabbage, Chinese, napa             1.430000   0.080  1.000  Factor for removal of wrapper leaves
05010720 5A   Cabbage, Chinese, mustard          0.199000   1.000  1.000
05010830 5A   Cauliflower                        0.199000   1.000  1.000
05011960 5A   Kohlrabi                           1.430000   1.000  1.000
05020630 5B   Broccoli raab                      8.620000   1.000  1.000
05020700 5B   Cabbage, Chinese, bok choy         8.620000   1.000  1.000
05021170 5B   Collards                           8.620000   1.000  1.000
05021940 5B   Kale                               8.620000   1.000  1.000
05022290 5B   Mustard greens                     8.620000   1.000  1.000
05023180 5B   Rape greens                        8.620000   1.000  1.000
05023890 5B   Turnip, greens                     8.620000   1.000  1.000
08001480 8    Eggplant                           0.090000   1.000  1.000
08002340 8    Okra                               0.233000   1.000  1.000  From non-bell pepper
08002700 8    Pepper, bell                       0.090000   1.000  1.000
08002701 8    Pepper, bell-babyfood              0.090000   1.000  1.000
08002710 8    Pepper, bell, dried                0.090000   1.000  1.000
08002711 8    Pepper, bell, dried-babyfood       0.090000   1.000  1.000
08002720 8    Pepper, nonbell                    0.233000   1.000  1.000
08002721 8    Pepper, nonbell-babyfood           0.233000   1.000  1.000
08002730 8    Pepper, nonbell, dried             0.233000   1.000  1.000
08003740 8    Tomatillo                          0.124000   1.000  1.000
08003750 8    Tomato                             0.124000   1.000  1.000
08003751 8    Tomato-babyfood                    0.124000   1.000  1.000
08003760 8    Tomato, paste                      0.124000   1.020  1.000
08003761 8    Tomato, paste-babyfood             0.124000   1.020  1.000
08003770 8    Tomato, puree                      0.124000   0.300  1.000
08003771 8    Tomato, puree-babyfood             0.124000   0.300  1.000
08003780 8    Tomato, dried                      0.124000  14.300  1.000
08003781 8    Tomato, dried-babyfood             0.124000  14.300  1.000
08003790 8    Tomato, juice                      0.124000   0.030  1.000
09010750 9A   Cantaloupe                         0.230000   1.000  1.000
09010800 9A   Casaba                             0.230000   1.000  1.000
09011870 9A   Honeydew melon                     0.230000   1.000  1.000
09013990 9A   Watermelon                         0.230000   1.000  1.000
09014000 9A   Watermelon, juice                  0.230000   0.030  1.000
09020210 9B   Balsam pear                        0.120000   1.000  1.000
09020880 9B   Chayote, fruit                     0.047000   1.000  1.000
09021020 9B   Chinese waxgourd                   0.120000   1.000  1.000
09021350 9B   Cucumber                           0.120000   1.000  1.000
09023080 9B   Pumpkin                            0.047000   1.000  1.000
09023090 9B   Pumpkin, seed                      0.047000   1.000  1.000
09023560 9B   Squash, summer                     0.047000   1.000  1.000
09023561 9B   Squash, summer-babyfood            0.047000   1.000  1.000
09023570 9B   Squash, winter                     0.047000   1.000  1.000
09023571 9B   Squash, winter-babyfood            0.047000   1.000  1.000
10001060 10   Citrus citron                      0.409000   1.000  1.000
10001070 10   Citrus hybrids                     0.409000   1.000  1.000
10001080 10   Citrus, oil                        0.409000  82.000  1.000
10001800 10   Grapefruit                         0.217000   1.000  1.000
10001810 10   Grapefruit, juice                  0.217000   0.020  1.000
10001970 10   Kumquat                            0.409000   1.000  1.000
10001990 10   Lemon                              0.437000   1.000  1.000
10002000 10   Lemon, juice                       0.437000   0.020  1.000
10002001 10   Lemon, juice-babyfood              0.437000   0.020  1.000
10002010 10   Lemon, peel                        0.437000   1.000  1.000
10002060 10   Lime                               0.437000   1.000  1.000
10002070 10   Lime, juice                        0.437000   0.020  1.000
10002071 10   Lime, juice-babyfood               0.437000   0.020  1.000
10002400 10   Orange                             0.409000   1.000  0.400
10002410 10   Orange, juice                      0.409000   0.020  0.400
10002411 10   Orange, juice-babyfood             0.409000   0.020  0.400
10002420 10   Orange, peel                       0.409000   1.000  0.400
10003070 10   Pummelo                            0.217000   1.000  1.000
10003690 10   Tangerine                          0.409000   1.000  1.000
10003700 10   Tangerine, juice                   0.409000   0.020  1.000
11000070 11   Apple, fruit with peel             0.206000   1.000  0.600
11000080 11   Apple, peeled fruit                0.206000   1.000  0.600
11000081 11   Apple, peeled fruit-babyfood       0.206000   1.000  0.600
11000090 11   Apple, dried                       0.206000   8.000  0.600
11000091 11   Apple, dried-babyfood              0.206000   8.000  0.600
11000100 11   Apple, juice                       0.206000   0.010  0.600
11000101 11   Apple, juice-babyfood              0.206000   0.010  0.600
11000110 11   Apple, sauce                       0.206000   1.000  0.600
11000111 11   Apple, sauce-babyfood              0.206000   1.000  0.600
11001290 11   Crabapple                          0.206000   1.000  1.000
11002100 11   Loquat                             0.199000   1.000  1.000
11002660 11   Pear                               0.199000   1.000  1.000
11002661 11   Pear-babyfood                      0.199000   1.000  1.000
11002670 11   Pear, dried                        0.199000   6.250  1.000
11002680 11   Pear, juice                        0.199000   0.010  1.000
11002681 11   Pear, juice-babyfood               0.199000   0.010  1.000
11003100 11   Quince                             0.199000   1.000  1.000
12000120 12   Apricot                            0.362000   1.000  1.000
12000121 12   Apricot-babyfood                   0.362000   1.000  1.000
12000130 12   Apricot, dried                     0.362000   6.000  1.000
12000140 12   Apricot, juice                     0.362000   0.030  1.000
12000141 12   Apricot, juice-babyfood            0.362000   0.030  1.000
12000900 12   Cherry                             0.551000   1.000  1.000
12000901 12   Cherry-babyfood                    0.551000   1.000  1.000
12000910 12   Cherry, juice                      0.551000   0.030  1.000
12000911 12   Cherry, juice-babyfood             0.551000   0.030  1.000
12002300 12   Nectarine                          0.362000   1.000  1.000
12002600 12   Peach                              0.362000   1.000  1.000
12002601 12   Peach-babyfood                     0.362000   1.000  1.000
12002610 12   Peach, dried                       0.362000   7.000  1.000
12002611 12   Peach, dried-babyfood              0.362000   7.000  1.000
12002620 12   Peach, juice                       0.362000   0.030  1.000
12002621 12   Peach, juice-babyfood              0.362000   0.030  1.000
12002850 12   Plum                               0.402000   1.000  1.000
12002851 12   Plum-babyfood                      0.402000   1.000  1.000
12002860 12   Plum, prune, fresh                 0.402000   1.000  1.000
12002861 12   Plum, prune, fresh-babyfood        0.402000   1.000  1.000
12002870 12   Plum, prune, dried                 0.402000   2.900  1.000
12002871 12   Plum, prune, dried-babyfood        0.402000   2.900  1.000
12002880 12   Plum, prune, juice                 0.402000   0.030  1.000
12002881 12   Plum, prune, juice-babyfood        0.402000   0.030  1.000
14000030 14   Almond                             0.013000   1.000  1.000
14000031 14   Almond-babyfood                    0.013000   1.000  1.000
14000040 14   Almond, oil                        0.013000   1.000  1.000
14000041 14   Almond, oil-babyfood               0.013000   1.000  1.000
14000590 14   Brazil nut                         0.010000   1.000  1.000
14000680 14   Butternut                          0.010000   1.000  1.000
14000810 14   Cashew                             0.010000   1.000  1.000
14000920 14   Chestnut                           0.013000   1.000  1.000
14001550 14   Filbert                            0.010000   1.000  1.000
14001560 14   Filbert, oil                       0.010000   1.000  1.000
14001850 14   Hickory nut                        0.010000   1.000  1.000
14002130 14   Macadamia nut                      0.010000   1.000  1.000
14002690 14   Pecan                              0.010000   1.000  1.000
14002820 14   Pistachio                          0.013000   1.000  1.000
14003910 14   Walnut                             0.010000   1.000  1.000
21000440 M    Beef, meat                         0.010000   1.000  1.000
21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000
21000450 M    Beef, meat, dried                  0.010000   1.920  1.000
21000460 M    Beef, meat byproducts              0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000461 M    Beef, meat byproducts-babyfood     0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000470 M    Beef, fat                          0.010000   1.000  1.000
21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000
21000480 M    Beef, kidney                       0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000490 M    Beef, liver                        0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
21000491 M    Beef, liver-babyfood               0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
23001690 M    Goat, meat                         0.010000   1.000  1.000
23001700 M    Goat, meat byproducts              0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
23001710 M    Goat, fat                          0.010000   1.000  1.000
23001720 M    Goat, kidney                       0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
23001730 M    Goat, liver                        0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
24001890 M    Horse, meat                        0.010000   1.000  1.000
26003390 M    Sheep, meat                        0.010000   1.000  1.000
26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
26003400 M    Sheep, meat byproducts             0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
26003410 M    Sheep, fat                         0.010000   1.000  1.000
26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000
26003420 M    Sheep, kidney                      0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
26003430 M    Sheep, liver                       0.350000   1.470  1.000  Factor 1 to account for OH-PT-CA
27002220 D    Milk, fat                          0.030000   1.000  1.000
27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000
27012230 D    Milk, nonfat solids                0.030000   1.000  1.000
27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
27022240 D    Milk, water                        0.030000   1.000  1.000
27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000
27032251 D    Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000
29003120 M    Rabbit, meat                       0.010000   1.000  1.000
86010000 O    Water, direct, all sources         0.012200   1.000  1.000
86020000 O    Water, indirect, all sources       0.012200   1.000  1.000
95001280 O    Cottonseed, oil                    0.172000   0.050  1.000
95001281 O    Cottonseed, oil-babyfood           0.172000   0.050  1.000
95001750 O    Grape                              0.530000   1.000  0.650
95001760 O    Grape, juice                       0.530000   0.030  1.000
95001761 O    Grape, juice-babyfood              0.530000   0.030  1.000
95001770 O    Grape, leaves                      0.530000   1.000  1.000
95001780 O    Grape, raisin                      0.530000   3.700  1.000
95001790 O    Grape, wine and sherry             0.530000   0.030  1.000
95002770 O    Persimmon                          0.551000   1.000  1.000  From Cherry
95002890 O    Pomegranate                        0.551000   1.000  1.000  From Cherry
95003720 O    Tea, dried                         7.060000   1.000  1.000
95003730 O    Tea, instant                       7.060000   1.000  1.000
95003800 O    Tomato, Tree                       0.124000   1.000  1.000
Attachment 3.  Summary of the Acute Dietary Analysis Results for Tolfenpyrad.

U.S. Environmental Protection Agency                                  Ver. 2.02
DEEM-FCID ACUTE Analysis for 090111 TOLFENPYRAD                  (1994-98 data)
Residue file: 090111 Tolfenpyrad Acute Tol Juice PF 27ppb .R98
Adjustment factor #2 NOT used.
Analysis Date: 02-16-2012/11:59:27    Residue file dated: 02-16-2012/11:56:35/8
Daily totals for food and foodform consumption used.
Run Comment: ""
===============================================================================

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD
                  ---------- --------  ---------- --------  ---------- --------
U.S. Population:
                    0.061772    61.77    0.115917   115.92    0.245781   245.78
All infants:
                    0.039670    39.67    0.215898   215.90    0.563094   563.09
Children 1-2 yrs:
                    0.072680    72.68    0.186896   186.90    0.543704   543.70
Children 3-5 yrs:
                    0.075748    75.75    0.169428   169.43    0.445338   445.34
Children 6-12 yrs:
                    0.063718    63.72    0.108496   108.50    0.259444   259.44
Youth 13-19 yrs:
                    0.055872    55.87    0.108933   108.93    0.171462   171.46
Adults 20-49 yrs:
                    0.060546    60.55    0.111102   111.10    0.194507   194.51
Adults 50+ yrs:
                    0.061222    61.22    0.112822   112.82    0.191438   191.44
Females 13-49 yrs:
                    0.064780    64.78    0.111422   111.42    0.201754   201.75

Attachment 4.  Summary of the Chronic Dietary Analysis Results for Tolfenpyrad.

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for 090111 TOLFENPYRAD               (1994-98 data)
Residue file name: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\!DEEM Runs\Tolfenpyrad\090111 Tolfenpyrad Chronic Average Juice PF 12ppb PCTn.R98
                                                     Adjustment factor #2 used.
Analysis Date 02-16-2012/11:58:40     Residue file dated: 02-16-2012/11:57:03/8
Reference dose (RfD, Chronic) = .006 mg/kg bw/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.001694                28.2%

U.S. Population (spring season)             0.001669                27.8%
U.S. Population (summer season)             0.001761                29.4%
U.S. Population (autumn season)             0.001680                28.0%
U.S. Population (winter season)             0.001664                27.7%

Northeast region                            0.001734                28.9%
Midwest region                              0.001548                25.8%
Southern region                             0.001654                27.6%
Western region                              0.001877                31.3%

Hispanics                                   0.001564                26.1%
Non-hispanic whites                         0.001524                25.4%
Non-hispanic blacks                         0.002345                39.1%
Non-hisp/non-white/non-black                0.002942                49.0%

All infants (< 1 year)                      0.003092                51.5%
Nursing infants                             0.001440                24.0%
Non-nursing infants                         0.003718                62.0%
Children 1-6  yrs                           0.003439                57.3%
Children 7-12 yrs                           0.001788                29.8%

Females 13-19 (not preg or nursing)         0.001141                19.0%
Females 20+ (not preg or nursing)           0.001588                26.5%
Females 13-50 yrs                           0.001434                23.9%
Females 13+ (preg/not nursing)              0.001360                22.7%
Females 13+ (nursing)                       0.001641                27.3%

Males 13-19 yrs                             0.001445                24.1%
Males 20+ yrs                               0.001358                22.6%
Seniors 55+                                 0.001755                29.2%

Children 1-2 yrs                            0.004127                68.8%
Children 3-5 yrs                            0.003277                54.6%
Children 6-12 yrs                           0.001904                31.7%
Youth 13-19 yrs                             0.001297                21.6%
Adults 20-49 yrs                            0.001334                22.2%
Adults 50+ yrs                              0.001726                28.8%
Females 13-49 yrs                           0.001390                23.2%

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PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OECA/ OC/ CASPD 2. OMB control number b. G None a. 2 0 6 0  0 0 3 5 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Sewage Sludge Treatment Plant Incineration ( 40 CFR Part 60, Subpart O).

8. Agency form number( s) ( If applicable) 1063.08 9. Keywords Clean Air Act, air pollution control, Environmental Protection 10. Abstract Owners and operators of sewage sludge incinerators are required to monitor, record, and under specified circumstances, report the following: the pressure drop across the control device, oxygen content of the incinerator exhaust gas, temperature profile of the incinerator, sludge feed rate to the incinerator, and the moisture and volatiles content of the sludge. Metals testing would be required during the initial performance test. Semiannual reports of excess emissions are also required.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. X Business or other for profit e. Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and record keeping hour burden a. Number of respondents 154 b. Total annual responses 294 1. Percentage of these responses collected electronically % c. Total annual hours requested 9,089 d. Current OMB inventory 9,089 e. Difference 0 f. Explanation of difference 1. Program Change 2. Adjustment ____________ ________ 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 700 b. Total annual costs ( O& M) 5,145 c. Total annualized cost requested 5,845 d. Current OMB inventory 4,690 e. Difference 1,155 f. Explanation of difference 1. Program change 2. Adjustment 1,155 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Kelli A. Smith Phone: ( 202) 564 2257 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

© It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Date OMB 83 I 10/ 95


[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Page 27820]
[FR Doc No: 2018-12814]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Request To Release Airport Property

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Intent to Rule on Request to Release Airport Property
at the Curtis Municipal Airport (47V), Curtis, Nebraska.

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SUMMARY: The FAA proposes to rule and invites public comment on the
release of land at the Curtis Municipal Airport, Curtis, Nebraska.

DATES: Comments must be received on or before July 16, 2018.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Lynn D. Martin, Airports Compliance
Specialist, Federal Aviation Administration, Airports Division, ACE-
610C, 901 Locust, Room 364, Kansas City, MO 64106.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to: Mr. Douglas Schultz, City Clerk, P.O. Box 6,
Curtis, NE 69025-0006<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Lynn D. Martin, Airports Compliance
Specialist, Federal Aviation Administration, Airports Division, ACE-
610C, 901 Locust, Room 364, Kansas City, MO 64106,<PHONE_NUMBER>,
[email protected].
    The request to release property may be reviewed, by appointment, in
person at this same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release approximately 0.81  acres of airport
property at the Curtis Municipal Airport (47V) under the provisions of
49 U.S.C. 47107(h)(2). On April 30, 2018, Mr. Schultz, the City Clerk
of Curtis, NE requested from the FAA that approximately 0.81 acres of airport property be released for sale to the City of
Curtis for them to sell to the Welch Seed LLC for a portion of their
agricultural seed sales business. On June 7, 2018, the FAA determined
that the request to release property at the Curtis Municipal Airport
(47V) submitted by the Sponsor meets the procedural requirements of the
Federal Aviation Administration and the release of the property does
not and will not impact future aviation needs at the airport. The FAA
may approve the request, in whole or in part, no sooner than thirty
days after the publication of this notice.
    The following is a brief overview of the request:
    The Curtis Municipal Airport (47V) is proposing the release of
airport property totaling 0.81 acres, more or less. This land is to be
used for a portion of an agricultural seed sales business. The release
of land is necessary to comply with Federal Aviation Administration
Grant Assurances that do not allow federally acquired airport property
to be used for non-aviation purposes. The sale of the subject property
will result in the land at the Curtis Municipal Airport (47V) being
changed from aeronautical to non-aeronautical use and release the lands
from the conditions of the Airport Improvement Program Grant Agreement
Grant Assurances. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and
(iii), the airport will receive fair market value for the property,
which will be subsequently reinvested in another eligible airport
improvement project for general aviation facilities at the Curtis
Municipal Airport.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT. In
addition, any person may, upon appointment and request, inspect the
application, notice and other documents determined by the FAA to be
related to the application in person at the Curtis Municipal Airport.

    Issued in Kansas City, MO, on June 7, 2018.
Jim A. Johnson,
Director, Airports Division.
[FR Doc. 2018-12814 Filed 6-13-18; 8:45 am]
 BILLING CODE 4910-13-P