[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17160-17162]
[FR Doc No: 2021-06696]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-3183 and FDA-2019-E-3184]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TPOXX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined the regulatory review period for TPOXX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by June 1,
2021. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by September 28,
2021. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 1, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 1, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your

comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-3183 and FDA-2019-E-3184 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; TPOXX.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product TPOXX
(tecovirimat monohydrate). TPOXX is indicated for treatment of human
smallpox disease in adults and pediatric patients weighing at least 13
kilograms.
    Limitations of Use:
     The effectiveness of TPOXX for treatment of smallpox
disease has not been determined in humans because adequate and well-
controlled field trials have not been feasible, and inducing smallpox
disease in humans to study the drug's efficacy is not ethical.
     TPOXX efficacy may be reduced in immunocompromised
patients based on studies demonstrating reduced efficacy in
immunocompromised animal models.
    Subsequent to this approval, the USPTO received a patent term
restoration application for TPOXX (U.S. Patent Nos. 7,737,168 and
8,124,643) from SIGA Technologies, Inc., and the USPTO requested FDA's
assistance in determining the patent's eligibility for patent term
restoration. In a letter dated October 29, 2019, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of TPOXX represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TPOXX is 4,601 days. Of this time, 4,383 days occurred during the
testing phase of the regulatory review period, while 218 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
December 9, 2005. The applicant claims December 8, 2005, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was December
9, 2005, which was 30 days after FDA receipt of the IND.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act or section
351 of the Public Health Service Act: December 8, 2017. FDA has
verified the applicant's claim that the new drug application (NDA) for
TPOXX (NDA 208627) was initially submitted on December 8, 2017.
    3. The date the application was approved: July 13, 2018. FDA has
verified the applicant's claim that NDA 208627 was approved on July 13,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,273 days or 1,585 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: March 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06696 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Pages 54776-54777]
[FR Doc No: 2014-21781]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0189]

Agency Information Collection Activities; Revision of an Approved
Information Collection: Hours of Service (HOS) of Drivers Regulations

AGENCY: FMCSA, DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. FMCSA requests approval
to revise and extend an ICR entitled, ``Hours of Service (HOS) of
Drivers Regulations.'' The HOS rules require most commercial motor
vehicle (CMV) drivers to maintain on the CMV a record of duty status
(RODS) current to the last change in duty status. The RODS is critical
to FMCSA's safety mission because it helps roadside enforcement
officials determine if CMV drivers are complying with the HOS rules
limiting driver on-duty and driving time and requiring periodic off-
duty time. The information helps FMCSA protect the public by reducing
the number of tired CMV drivers on the highways.

DATES: Please send your comments by October 14, 2014. OMB must receive
your comments by this date in order to act on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA 2014-0189. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or
mailed to the Office of Information and Regulatory Affairs, Office of
Management and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mr. Robert F. Schultz, Driver and
Carrier Operations Division, Department of Transportation, Federal
Motor Carrier Safety Administration, West Building 6th Floor, 1200 New
Jersey Avenue SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Office hours are from 9 a.m. to 5 p.m., Monday
through Friday, except Federal Holidays.

SUPPLEMENTARY INFORMATION:
    Title: Hours of Service (HOS) of Drivers Regulations.
    OMB Control Number: 2126-0001.
    Type of Request: Revision of an information collection.
    Respondents: Motor Carriers of Property and Passengers, Drivers of
CMVs.
    Estimated Number of Respondents: 3.17 million (2.84 million CMV
drivers + 0.33 million motor carriers).
    Estimated Time per Response: CMV driver using paper RODS: 11
minutes. CMV driver using technology: 2 minutes. Motor carrier: 3
minutes.
    Expiration Date: 12/31/2014.
    Frequency of Response: Drivers: 240 days per year; Motor Carriers:
240 days per year.
    Estimated Total Annual Burden: 106.89 million hours.
    Background: Statutory authority for regulating the HOS of drivers
operating CMVs in interstate commerce is derived from 49 U.S.C. 31136
and 31502. The penalty provisions are located at 49 U.S.C. 521, 522 and
526, as amended. The rule is codified at 49 CFR 395.8. The FMCSRs also
state:

    ``No driver shall operate a commercial motor vehicle, and a
commercial motor carrier shall not require or permit a driver to
operate a commercial motor vehicle, while the driver's ability or
alertness is so impaired, or so likely to become impaired, through
fatigue, illness, or any other cause, as to make it unsafe for him/
her to begin or continue to operate the commercial motor vehicle''
(49 CFR 392.3).

    The FMCSA regulates the amount of time a CMV driver may drive or
otherwise be on duty, in order to ensure that adequate time is
available to the driver for rest. A driver must accurately record his
or her duty status (driving, on duty not driving, off duty, sleeper
berth) at all points during the 24-hour period designated by the motor
carrier (49 CFR 395.8(a)(1)). This record of duty status (RODS) must be
made on a specified grid (Section 395.8(g)). The term ``logbook'' is
often used in the industry to denote the collection of the most recent
RODS of the driver. A driver must have the RODS for the previous 7
consecutive days in the CMV at all times (Section 395.8(k)(2)). The
RODS must be submitted to the motor carrier along with any supporting
documents, such as fuel receipts and toll tickets, that could assist in
verifying the accuracy of entries on the RODS. The HOS rules do not
require motor carriers to submit this information to FMCSA. However,
motor carriers must retain these records for a minimum of 6 months from
the date of receipt and make them available to enforcement officials
upon request (Section 395.8(k)(1)). The HOS rules provide three methods
of recording driver duty status:
    (1) Paper RODS: This grid form requires the driver to graph time
and location on a paper record over a 24-hour period (Section
395.8(g)). It must be present on the CMV in the absence of a regulatory
exception.
    (2) Time Record: ``Short haul'' CMV drivers do not have to maintain
a RODS onboard the vehicle if their motor carrier maintains a time
record showing for each duty day when driver reported for duty, when he
or she was released from duty, and the total hours on duty (Section
395.1(e)).
    (3) Automatic On-Board Recording Device (AOBRD): An electronic
record is permitted if it is created and maintained by an AOBRD as
defined by Section 395.2. The record must include all the information
that would appear on a paper log, and the driver or carrier must be
capable of producing this information upon demand.
    On March 28, 2014, the Agency published a supplemental notice of
proposed rulemaking proposing rules that would require motor carriers
to use on-board technology to record their HOS regulations, and seeking
public comment on them (79 FR 17656). This rulemaking does not affect
this ICR because compliance with the final rule, when published, will
not be required until after the 3-year timeframe of this PRA estimate.
    As a condition of receiving certain federal grants, States agree to
adopt and enforce the FMCSRs, including the HOS

rules, as State law. As a result, State enforcement inspectors use the
RODS and supporting documents to determine whether CMV drivers are
complying with the HOS rules. In addition, FMCSA uses the RODS during
on-site compliance reviews (CRs) and targeted reviews of motor
carriers. In addition, Federal and State courts rely upon the RODS as
evidence of driver and motor carrier violations of the HOS regulations.
This information collection supports the DOT's Strategic Goal of Safety
because the information helps the Agency ensure the safe operation of
CMVs in interstate commerce on our Nation's highways.
    The PRA burden estimate is currently 184.38 million hours, approved
by OMB on December 11, 2011. The expiration date of this ICR is
December 31, 2014. Through this ICR, FMCSA requests a revision of the
paperwork burden of 2126-0001. The Agency requests a reduction in the
burden hours based on two program adjustments and is not the result of
amendments of the HOS rules. The program adjustments are: (1) A lower
estimate of the number of CMV drivers who are subject to the HOS rules;
and (2) an estimate of the burden reduction experienced by those CMV
drivers voluntarily using electronic HOS technology. First, the Agency
reduces its estimate of the number of drivers subject to the HOS
recordkeeping requirements from 4.6 million to 2.84 million. Second,
FMCSA estimates that 10% of drivers currently are obtaining burden
reductions because they use electronic HOS technology.
    On June 24, 2014, FMCSA published a Federal Register notice
allowing for a 60-day comment period on this ICR. The agency received
no comment in response to that notice.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the FMCSA to perform its functions; (2) the
accuracy of the estimated burden; (3) ways for the FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued under the authority delegated in 49 CFR 1.87 on:
September 5, 2014.
G. Kelly Regal,
Associate Administrator, Office of Research and Information Technology
and Chief Information Officer.
[FR Doc. 2014-21781 Filed 9-11-14; 8:45 am]
BILLING CODE 4910-EX-P


Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 1 of 21 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES MEMORANDUM Date: August 1, 2006 Subject: Triadimefon & Triadimenol: Aggregate Acute, Chronic, and Short Term Risk Assessments Reflecting July, 2006 Risk Mitigation in Response to the Phase 4 Triadimefon RED.

DP Barcode: D331455 PC Codes: 109901 and 127201 40 CFR § : 180.410 Chemical Class: Azole From: Yvonne Barnes, Chemist Reregistration Branch II and Sheila Piper, Chemist Chemistry and Exposure Branch Health Effects Division ( 7509P)

Through: William J. Hazel, Branch Chief Reregistration Branch II Health Effects Division ( 7509P)

To: Richard Griffin, Risk Assessor Reregistration Branch II Health Effects Division ( 7509P) and John Pates, Chemical Review Manager Reregistration Branch I Special Review and Reregistration Division ( 7508P) Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 2 of 21 Executive Summary Revised acute and chronic aggregate dietary ( triadimefon and triadimenol) food and water exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM FCID   , Version 2.03), which uses food consumption data from the U. S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. The analyses were performed in response to the registrant, Bayer CropScience's agreement to voluntarily cancel all food uses, except for pre plant and post harvest use on pineapples for triadimefon. Food uses to be cancelled include apples, pears, grapes, and raspberries ( commercial or residential). EPA will issue a 6f notice proposing to cancel these uses; Bayer will waive the 6 month comment period to 30 days.

Acute Aggregate Dietary Exposure Characterization of Input Data This risk assessment represents aggregation of triadimefon and triadimenol residues resulting from the metabolism of triadimefon as well as the use of triadimenol as an active ingredient. This dietary exposure and risk assessment for triadimefon and triadimenol includes the following: field trial data for pineapples and bananas, seed treatment tolerances for barley, corn, oat, rye, cottonseed, and wheat and the new drinking water mitigation proposed by Bayer: two applications per season at 2.7 lb ai/ A and 14 day interval made to the entire golf course. The assessment includes the time series data from the PRZM EXAMS model of the drinking water scenario. Although exposure to residue in/ on banana and pineapple food forms and drinking water were estimated probabilistically, 100% CT was used for all foods and tolerances were used ( grain crops and cottonseed products). As a result, standard policy is to evaluate at the 95th percentile since tolerance level residues and 100% crop treated was used.

Acute Aggregate Dietary Exposure Results Acute Aggregate Dietary Food Only Triadimefon Food ( pineapples only) + Triadimenol Food ( bananas and seed treatments)

The acute aggregate dietary exposure estimates from food only are below HED's level of concern (< 100% aPAD) at the 95th percentile of exposure. The acute aggregate dietary risk at the 95th percentile of exposure from food only is 15% of the aPAD for the U. S. population and 33% of the aPAD for children 1 2 yrs, the most highly exposed population subgroup.

Acute Aggregate Dietary Water Only DW from 2 apps at 2.7 lb ai/ A to Entire Course The acute aggregate dietary exposure estimates from drinking water only using the Florida turf ( two applications) for drinking water are below HED's level of concern (< 100% aPAD) at the 95th percentile of exposure. At the 95th percentile of exposure, risks were estimated to be 24% and 85% of the aPAD for the U. S. population and all infants (< 1 yr), respectively. Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 3 of 21 Acute Aggregate Dietary ( food + water) Triadimefon Food ( pineapples only) + Triadimenol Food ( bananas and seed treatments) + DW from 2 apps at 2.7 lb ai/ A to Entire Course The acute aggregate dietary exposure estimates from food and drinking water using Florida turf with two applications for drinking water are below HED's level of concern (< 100% aPAD) at the 95th percentile of exposure. At the 95th percentile of exposure risks were estimated to be 33% and 94% of the aPAD for the U. S. population and all infants (< 1 yr), respectively.

Chronic Aggregate Dietary Exposure Results Chronic Dietary Food Only Triadimefon Food ( pineapples only) + Triadimenol Food ( bananas and seed treatments)

The chronic aggregate dietary exposure estimates from food only are below HED's level of concern (< 100% cPAD) for the U. S. population and all population subgroups. The chronic aggregate dietary risk from food only for the U. S. population is 6% of the cPAD and 15% of the cPAD for children 1 2 yrs, the most highly exposed population subgroup.

Chronic Aggregate Water Only DW from 2 apps at 2.7 lb ai/ A to Entire Course The chronic aggregate dietary exposure estimates from drinking water only using the Florida turf with two applications, are below HED's level of concern (< 100% cPAD) for the U. S. population and all population subgroups. The aggregate dietary risk from drinking water for the U. S. population is 12% of the cPAD and 40% of the cPAD for all infants (< 1 yr), the most highly exposed population subgroup.

Chronic Aggregate ( food + water) Chronic Aggregate Dietary/ Triadimefon Food ( pineapples only) + Triadimenol Food ( bananas and seed treatments) + DW from 2 apps at 2.7 lb ai/ A to Entire Course The chronic aggregate dietary exposure estimates from food and drinking water using Florida turf, two applications are below HED's level of concern (< 100% cPAD) for the U. S. population and all population subgroups. The aggregate dietary risk from food and drinking water for the U. S. population is 18% of the cPAD and 47% of the cPAD for all infants (< 1 yr), the most highly exposed population subgroup.

Short term Aggregate Short term Aggregate ( adults) Application to ornamentals ( azaleas) + chronic dietary + chronic water The short term aggregate risk reflecting residential handler scenarios: Application to ornamentals ( azaleas = worst case residential handler ( MOE of 1100 for dermal + inhalation). The resulting shortterm aggregate has a MOE of 920 which exceeds HED level of concern. Another scenario Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 4 of 21 residential handler ( mixer, loader, applicator) for low pressure hand wand application of a WP to green house ornamental has a MOE of 1700 ( dermal + inhalation). The resulting short   term aggregate MOE is 1300.

Short term Aggregate ( toddlers) Post application exposure to sod farm turf + chronic dietary + chronic water Short term aggregate for toddlers due to post application exposure to treated sod ( i. e. sod transplanted to a residential lawn). The MOE ( combined hand to mouth, dermal and inhalation) at a sod pre harvest interval of 15 days was 1100; the MOE was of concern (< 1000) at 14 days. The chronic dietary ( food + water) exposure for children 1 2 years is a MOE of 3100. The resulting short term aggregate MOE was 810.

On day 17, the combined MOE's for toddlers on sod treated at the 2.7 lb a. i./ A rate is 1700. When this rate is aggregated with the chronic dietary ( food and water) MOE of 3100 MOE, the resultant aggregate is 1100. The individual MOE's are as follows: a) Hand To Mouth = 2500; b) Object To Mouth = 10,000; c) Soil = 31,000; Dermal = 11,000.

The short term toddler aggregate on day 16 is 920.

I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute dietary, chronic dietary and aggregate assessments, the risk is expressed as a percentage of a maximum acceptable dose ( i. e., the dose which the Health Effects Division 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 the Reference Dose ( RfD) divided by the FQPA Safety Factor.

For acute and non cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic dietary risk assessments in more detail are available on the EPA pesticides web site: " Available Information on Assessing Exposure from Pesticides, A User's Guide," 06/ 21/ 2000, web link: http:// www. epa. gov / fedrgstr/ EPA PEST / 2000/ July/ Day 12/ 6061. pdf; or see SOP 99.6 ( 08/ 20/ 1999).

The two most recent dietary risk assessments for triadimefon and triadimenol were conducted by Y. Barnes and S. Piper ( DP Barcode D314778, Revised 06 July 2006) and S. Ary ( DP Barcode D314778, 23 NOV 2005).

II. Residue Information Tolerances are established for residues of triadimefon [ 1( 4 chlorophenoxy) 3, 3 dimethyl 1( 1H 1, 2, 4 triazol 1 yl) 2 butanone] and its metabolites containing chlorophenoxy and triazole moieties ( expressed as the parent compound) in/ on various plant and animal commodities [ 40 CFR § 180.410]. Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 5 of 21 Triadimenol, b( 4 chlorophenoxy) a( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 ethanol, is a systemic fungicide registered for use in the United States as a seed treatment for barley, corn, cotton, oats, rye, and wheat. Additionally, an import tolerance on bananas has been established [ 40 CFR § 180.450].

Bayer CropScience has agreed to voluntarily cancel all food uses, except for pre plant and postharvest use on pineapples for triadimefon. Food uses to be cancelled include apples, pears, grapes, and raspberries ( in both commercial and residential settings). EPA will issue a 6f notice proposing to cancel these uses; Bayer will waive the 6 month comment period to 30 days. Once the 30 day comment period closes, EPA will issue a cancellation order, with an existing stocks provision of 1 year from the effective date of cancellation. The associated tolerances will be proposed for revocation.

The qualitative nature of triadimefon and triadimenol residues in plants is understood based on adequate metabolism studies conducted with grapes, cucumbers, tomatoes, and wheat. The Health Effects Division ( HED) Metabolism Assessment Review Committee ( MARC) has determined that the residues of concern in plants are triadimefon, triadimenol, KWG 1323, KWG 1342, and, in wheat only, KWG 1732 ( S. Knizner, HED MARC memorandum, 01/ 03/ 1994). Tolerances in poultry commodities are unnecessary for triadimefon as there are no treated poultry feed items. HED concluded that the then supported uses on apples, grapes, pears, pineapples, and raspberries result in a 40 CFR § 180.6( a)( 3) situation for ruminant commodities; i. e., there was and still is no reasonable expectation of finite residues in ruminant commodities. Therefore, tolerances in animal commodities are not required at the present time.

Residue Data used for Acute and Chronic Dietary Assessments The anticipated residue estimates are based on field trial data ( pineapples and bananas) and seed treatment tolerances were used for barley, corn, oat, rye and cottonseed and wheat. All triadimefon and triadimenol acute and chronic residue estimates for crop commodities are listed in Table 1. As stated above, the residues of concern in risk assessment include three of triadimefon's metabolites: triadimenol, KWG 1323, and KWG 1342. Since MARC concluded that triadimefon, triadimenol, KWG 1323, and KWG 1342 are residues of concern, residue data for these metabolites were needed for conducting a dietary risk assessment.

Residue Estimates for Individual Crops Pineapple: Pineapple field trial data submitted in MRID 42342307 were used. A total of ten trials were conducted and samples were analyzed for triadimefon, triadimenol, KWG 1323, and KWG 1342. The method LOQ was determined at 0.01 ppm. For values reported below the LOQ, half the LOQ was used in calculating the total combined residues of triadimefon, triadimenol, KWG 1323, and KWG 1342. All residue values were corrected to 1x application rate. The estimated % CT for pineapples of 100% was used for the acute and chronic dietary risk assessments.

Bananas: Banana field trial data submitted in MRID 40615021 were used. A total of ten trials were conducted and samples were analyzed for triadimefon, triadimenol, KWG 1323, and KWG 1342. The method LOQ was determined at 0.01 ppm. For values reported below the LOQ, half the LOQ was used in calculating the total combined residues of triadimefon, triadimenol, KWG 1323, and Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 6 of 21 KWG 1342. All residue values were corrected to 1x application rate. The estimated % CT for bananas of 100% was used for the acute and chronic dietary risk assessments.

Table 1: Triadimefon and Triadimenol Data and Residue Estimates Used in Dietary Analyses Anticipated Residue Estimates/ Tolerance RAC Classification1 Data Source Years No. of Samples No. of Detects % CT Avg. 2 % CT Max. 2 Processing Factors3 Acute ( Tol., AR, RDF) ppm Chronic ( Tol., AR) ppm Pineapple NB or PB Field Trial MRID 42342307 1992 10 10 100 100 dried at 5.0 TOTALZ= 0 TOTALLOD= 0 LODRES= 0.005 0.05, 0.08, 0.10, 0.10, 0.11, 0.08, 0.09, 0.06 0.07, 0.05 AR ( 0.079)

Banana NB or PB Field Trial MRID 40615201 1998 10 10 100 100 dried at 3.9 TOTALZ= 0 TOTALNZ= 10 0.04, 0.05, 0.02 0.05, 0.04, 0.015, 0.015, 0.025, 0.015, 0.03 AR ( 0.03)

Cottonseed B Tolerance    100 100  0.02 0.02 Cereal, Corn & Grains NB, PB or B Tolerance    100 100 bran at 2.1 0.05 0.05 1. Classification of blended ( B), partially blended ( PB), not blended ( NB). 2. 100% CT was used in the dietary assessment. 3. Processing study information may be found in the Chemistry Review Document, guideline section 860.1520 Processed Food and Feed ( S. Ary, D314742, 9/ 16/ 2005).

Processing Factors Data from the processing studies were used in this assessment for several commodities along with DEEM 7.81 default processing factors for dried pineapple ( 5.0x), bananas ( 3.9x), barley and oat bran ( 2.1x). All other processed commodities showed little or no concentration in the available processing studies. For detailed considerations of processing factors see " Triadimefon. Summary of Analytical Chemistry and Residue Data for the Reregistration Eligibility Decision ( RED) Document" under guideline section 860.1520 ( S. Ary, D314742, 09/ 16/ 2005).

III. Drinking Water Data Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 7 of 21 The drinking water values used in the dietary risk assessment were provided by the Environmental Fate and Effects Division ( EFED) in the following email correspondence ( J. Angier, 11 JUL 2006). Water residues were incorporated in to DEEM FCID   food categories of " water, direct, all sources" and " water, indirect, all sources." The estimated drinking water concentrations ( EDWCs) for triadimefon and triadimenol were moderately refined and calculated using PRZM ( Pesticide Root Zone Model) and EXAMS ( Exposure Analysis Modeling System) for use in the human health risk assessment. In this assessment, the EDWCs were calculated to reflect Bayer's July 2006 mitigation proposal to reduce the golf course use pattern to 2 applications at 2.7 lbs ai/ A and a golf course adjustment factor ( GCAFs) was applied to surface water. The PRZM EXAMS surface water modeling data point estimate from the 1 in 10 year annual concentration for FL turf was 19.633 ppb and used in the chronic dietary exposure assessment.

IV. Toxicological Information Both the acute and chronic dietary exposure estimates for triadimefon were evaluated based on a NOAEL of 3.4 mg/ kg/ day from a subchronic neurotoxicity study in rats ( R. Griffin, D325542, 23 JAN 2006). The triadimefon risk assessments are based on the dietary endpoint only except for short term dermal assessment which relied on a 21 day rat dermal toxicity study having a NOAEL of 300 mg/ kg/ day. There are no residential exposures resulting from registered uses of triadimenol. A summary of the toxicological doses and endpoints selected for these risk assessments is provided in Table 2.

Table 2: Summary of Toxicological Doses and Endpoints for Triadimefon and Triadimenol Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( general population) NOAEL = 3.4 mg/ kg/ day UF = 1000 Acute RfD = 0.0034 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF aPAD = 0.0034 mg/ kg/ day Subchronic neurotoxicity study in rats. LOAEL = 54.6/ 68.7 mg/ kg/ day based largely on hyperactivity.

Chronic Dietary ( all populations) NOAEL = 3.4 mg/ kg/ day UF = 1000 Chronic RfD = 0.0034 mg/ kg/ day FQPA SF = 1X PAD = chronic RfD FQPA SF cPAD = 0.0034 mg/ kg/ day Subchronic neurotoxicity study in rats. LOAEL = 54.6/ 68.7 mg/ kg/ day based largely on hyperactivity.

Incidental Oral Short Term ( 1  30 days) NOAEL = 3.4 mg/ kg/ day UF = 1000 Residential MOE = 1000 Subchronic neurotoxicity study in rats. LOAEL = 54.6/ 68.7 mg/ kg/ day Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 8 of 21 Table 2: Summary of Toxicological Doses and Endpoints for Triadimefon and Triadimenol Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects based largely on hyperactivity.

Incidental Oral Intermediate Term ( 1  6 months) NOAEL = 3.4 mg/ kg/ day UF = 1000 Residential MOE = 1000 Subchronic neurotoxicity study in rats. LOAEL = 54.6/ 68.7 mg/ kg/ day based largely on hyperactivity.

Dermal Short Term ( 1  30 days) Dermal NOAEL = 300 mg/ kg/ day Residential MOE = 1000 Occupational MOE = 100 21 Day Dermal Toxicity in rabbits. The LOAEL= 1000 mg/ kg/ day based on increased reactivity and activity in the females.

Dermal Intermediate Term ( 1  6 months) Dermal NOAEL = 300 mg/ kg/ day Residential MOE = 1000 Occupational MOE = 100 21 Day Dermal Toxicity in rabbits. The LOAEL= 1000 mg/ kg/ day based on increased reactivity and activity in the females.

Dermal Long Term (> 6 months) Not Applicable Not Applicable Quantitative risk assessment is not required since no long term dermal exposure is expected.

Inhalation Short Term ( 1  30 days) NOAEL = 3.4 mg/ kg/ day ( Inhalation absorption rate = 100%) Residential MOE = 1000 Occupational MOE = 100 Subchronic neurotoxicity study in rats. LOAEL = 54.6/ 68.7 mg/ kg/ day based largely on hyperactivity.

Inhalation Intermediate Term ( 1  6 months) NOAEL = 3.4 mg/ kg/ day ( Inhalation absorption rate = 100%) Residential MOE = 1000 Occupational MOE = 100 Subchronic neurotoxicity study in rats. LOAEL = 54.6/ 68.7 mg/ kg/ day based largely on hyperactivity.

Inhalation Long Term (> 6 months) Not Applicable Not Applicable Quantitative risk assessment is not required since no long term exposure is expected.

Cancer ( oral, dermal, inhalation) Classification: Category C " possible human carcinogen" based on statistically significant increase in thyroid adenomas in male Wistar rats and statistically significant increases in hepatocellular adenomas in both sexes of the NMRI mouse.

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable V. Results/ Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM FCID   analyses estimate the dietary exposure of the U. S. Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 9 of 21 population and various population subgroups. The acute and chronic dietary exposure analyses reported in Tables 3 4 for the general U. S. population, all infants ( less than 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, adults 50+ years, and females 13 49.

The acute aggregate dietary exposure estimates from food only are below HED's level of concern (< 100% aPAD) at the 95th percentile of exposure. The acute aggregate dietary risk at the 95th percentile of exposure from food only is 15% of the aPAD for the U. S. population and 32% of the aPAD for children 1 2 yrs, the most highly exposed population subgroup ( see Table 3).

The acute aggregate dietary exposure estimates from drinking water only using the Florida turf ( two applications) for drinking water are below HED's level of concern (< 100% aPAD) at the 95th percentile of exposure. At the 95th percentile of exposure risks were estimated to be 24% and 85% of the aPAD for the U. S. population and all infants (< 1 yr), respectively ( see attachment 10).

The acute aggregate dietary exposure estimates from food and drinking water using Florida turf with two applications for drinking water are below HED's level of concern (< 100% aPAD) at the 95th percentile of exposure. At the 95th percentile of exposure risks were estimated to be 33% and 94% of the aPAD for the U. S. population and all infants (< 1 yr), respectively ( see Table 3).

Table 3. Results of Aggregate Acute Dietary Exposure Analysis for Using DEEM FCID Food Only Food + Drinking Water 95th Percentile 95h Percentile Population Subgroup aPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.0034 0.000520 15.29 0.001106 32.52 All Infants (< 1 year old) 0.0034 0.000828 24.36 0.003190 93.82 Children 1 2 years old 0.0034 0.001083 31.86 0.001959 57.63 Children 3 5 years old 0.0034 0.000923 27.16 0.001765 51.92 Children 6 12 years old 0.0034 0.000668 19.64 0.001210 35.58 Youth 13 19 years old 0.0034 0.000440 12.95 0.000859 25.28 Adults 20 49 years old 0.0034 0.000334 9.82 0.000942 27.72 Adults 50+ years old 0.0034 0.000249 7.33 0.000921 27.10 Females 13 49 year old 0.0034 0.000322 9.47 0.000936 27.52 The chronic aggregate dietary exposure estimates from food only are below HED's level of concern (< 100% cPAD) for the U. S. population and all population subgroups. The chronic aggregate dietary risk from food only for the U. S. population is 6% of the cPAD and 15% of the cPAD for children 1 2 Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 10 of 21 yrs, the most highly exposed population subgroup ( see Table 4).

The chronic aggregate dietary exposure estimates from drinking water only using the Florida turf with two applications, are below HED's level of concern (< 100% cPAD) for the U. S. population and all population subgroups. The aggregate dietary risk from drinking water for the U. S. population is 12% of the cPAD and 40% of the cPAD for all infants (< 1 yr), the most highly exposed population subgroup ( see Attachment 12).

The chronic aggregate dietary exposure estimates from food and drinking water using Florida turf, two applications are below HED's level of concern (< 100% cPAD) for the U. S. population and all population subgroups. The aggregate dietary risk from food and drinking water for the U. S. population is 18% of the cPAD and 47% of the cPAD for all infants (< 1 yr), the most highly exposed population subgroup ( see Table 4).

Table 4. Results of Aggregate Chronic Dietary Risk Analysis from ( Food Alone) and ( Food + Drinking Water Entire Course) Using DEEM FCID Population Subgroup Food Alone Food + Drinking Water ( Entire Course) cPAD ( mg/ kg/ day)

Exposure ( mg/ kg/ day) % cPAD Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.0034 0.000194 5.7% 0.000607 17.9%

All Infants (< 1 year old) 0.0034 0.000227 6.7% 0.001584 46.6%

Children 1 2 years old 0.0034 0.000493 14.5% 0.001108 32.6%

Children 3 5 years old 0.0034 0.000471 13.9% 0.001047 30.8%

Children 6 12 years old 0.0034 0.000323 9.5% 0.000720 21.2%

Youth 13 19 years old 0.0034 0.000203 6.0% 0.000503 14.8%

Adults 20 49 years old 0.0034 0.000154 4.5% 0.000540 15.9%

Adults 50+ years old 0.0034 0.000117 3.4% 0.00052 15.4%

Females 13 49 year old 0.0034 0.000147 4.3% 0.000532 15.6%

The short term aggregate risk reflecting residential handler scenarios: Application to ornamentals ( azaleas = worst case residential handler ( MOE of 1100 for dermal + inhalation). The resulting shortterm aggregate has a MOE of 920 which exceeds HED level of concern. Another scenario residential handler ( mixer, loader, applicator) for low pressure hand wand application of a WP to green house ornamental has a MOE of 1700 ( dermal + inhalation). The resulting short   term aggregate MOE is 1300.

Short term aggregate for toddlers due to post application exposure to treated sod ( i. e. sod transplanted to a residential lawn). The MOE ( combined hand to mouth, dermal and inhalation) at a sod pre harvest interval of 15 days was 1100; the MOE was of concern (< 1000) at 14 days. The chronic dietary ( food + water) exposure for children 1 2 years is a MOE of 3100. The resulting short term aggregate MOE was 810.

On day 17, the combined MOE's for toddlers on sod treated at the 2.7 lb a. i./ A rate is 1700. When this rate is aggregated with the chronic dietary ( food and water) MOE of 3100 MOE, the Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 11 of 21 resultant aggregate is 1100. The individual MOE's are as follows: a) Hand To Mouth = 2500; b) Object To Mouth = 10,000; c) Soil = 31,000; Dermal = 11,000. The short term toddler aggregate on day 16 is 920.

VI. List of Attachments Attachment 1 Acute Aggregate ( food only) Residue Input Data Attachment 2 Acute Aggregate ( food only) Residue Analysis Attachment 3 Acute Aggregate ( food + water) Residue Input Data Attachment 4 Acute Aggregate ( food + water) Residue Analysis Attachment 5 Chronic Aggregate ( food only) Residue Input Data Attachment 6 Chronic Aggregate ( food only) Residue Analysis Attachment 7 Chronic Aggregate ( food + water) Residue Input Data Attachment 8 Chronic Aggregate ( food + water) Residue Analysis Attachment 9 Acute Aggregate ( Water only) Residue Input Data Attachment 10 Acute Aggregate ( Water only) Residue Analysis Attachment 11 Chronic Aggregate ( Water only) Residue Input Data Attachment 12 Chronic Aggregate ( Water only) Residue Analysis Attachment 13 Short Term Aggregate Calculations cc: S. Piper, CEB Reading Files; Y. Barnes, RRB2 Reading Files RDI: 08/ 01/ 06 William Hazel; Richard Griffin 08/ 01/ 06; David Miller 08/ 02/ 06 7509P: CEB PY Room 10244: 308 2717: Triadimefon/ Triadimenol Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 12 of 21 Attachment 1: Acute Aggregate ( food only) Residue Input Data U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID Acute analysis for TRIADIMEFON Residue file name: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ AggregateFoodonly_ 7242006. R98 Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 09: 23: 21/ 8 Reference dose ( aRfD) = 0.0034 mg/ kg bw/ day Comment: Triadimefon + Triadimenol [ food only]  RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter # 1 Param # 2 Param # 3 Comment # Code       1 6 Apple, NB or PB 6 21 2006. rdf 2 6 Apple, B  6 21 2006. rdf 3 6 GrapesPB 6 21 2006. rdf 4 6 Pear, NB or PB 6 21 2006. rdf 5 6 Pineapples, FT 6 21 2006. rdf 6 6 new FDA Raspberry 06 29 2006. rdf 7 6 Banana, PBNB FT 6 21 2006. rdf 8 6 FLturf2applmaxDW_ triadimefon. rdf EPA Crop Food Name Def Res Adj. Factors RDL Comment Code Grp ( ppm) # 1 # 2 Pntr         95000230 O Banana 0.030000 1.000 1.000 7 95000231 O Banana babyfood 0.030000 1.000 1.000 7 95000240 O Banana, dried 0.030000 3.900 1.000 95000241 O Banana, dried babyfood 0.030000 3.900 1.000 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 2.100 1.000 15001200 15 Corn, field, flour 0.050000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 15001230 15 Corn, field, starch 0.050000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.000 1.000 15001241 15 Corn, field, syrup babyfood 0.050000 1.000 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.050000 1.000 1.000 15001260 15 Corn, pop 0.050000 1.000 1.000 15001270 15 Corn, sweet 0.050000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.050000 1.000 1.000 95001280 O Cottonseed, oil 0.020000 1.000 1.000 95001281 O Cottonseed, oil babyfood 0.020000 1.000 1.000 15002310 15 Oat, bran 0.050000 2.100 1.000 15002320 15 Oat, flour 0.050000 1.000 1.000 15002321 15 Oat, flour babyfood 0.050000 1.000 1.000 15002330 15 Oat, groats/ rolled oats 0.050000 1.000 1.000 15002331 15 Oat, groats/ rolled oats babyfood 0.050000 1.000 1.000 95002790 O Pineapple 0.079000 1.000 1.000 5 95002791 O Pineapple babyfood 0.079000 1.000 1.000 5 95002800 O Pineapple, dried 0.079000 1.000 1.000 5 95002810 O Pineapple, juice 0.079000 1.000 1.000 5 95002811 O Pineapple, juice babyfood 0.079000 1.000 1.000 5 15003280 15 Rye, grain 0.050000 1.000 1.000 15003290 15 Rye, flour 0.050000 1.000 1.000 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 2.100 1.000 Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 13 of 21 Attachment 2: Acute Aggregate ( food only) Residue Analysis U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID ACUTE Analysis for TRIADIMEFON ( 1994 98 data) Residue file: AggregateFoodonly_ 7242006. R98 Adjustment factor # 2 used. Analysis Date: 07 25 2006/ 09: 27: 48 Residue file dated: 07 25 2006/ 09: 23: 21/ 8 Daily totals for food and foodform consumption used. MC iterations = 1000 MC list in residue file MC seed = 10 Run Comment: " Triadimefon + Triadimenol [ food only]" ===============================================================================

Summary calculations ( per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD       U. S. Population: 0.000520 15.29 0.000855 25.14 0.001490 43.82 All infants: 0.000828 24.36 0.001298 38.18 0.002021 59.44 Children 1 2 yrs: 0.001083 31.86 0.001681 49.45 0.002720 80.01 Children 3 5 yrs: 0.000923 27.16 0.001289 37.90 0.002230 65.58 Children 6 12 yrs: 0.000668 19.64 0.000931 27.39 0.001446 42.54 Youth 13 19 yrs: 0.000440 12.95 0.000646 19.00 0.001076 31.64 Adults 20 49 yrs: 0.000334 9.82 0.000516 15.17 0.000865 25.43 Adults 50+ yrs: 0.000249 7.33 0.000350 10.29 0.000548 16.11 Females 13 49 yrs: 0.000322 9.47 0.000479 14.09 0.001134 33.36 Attachment 3: Acute Aggregate ( food + water) Residue Input Data U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID Acute analysis for TRIADIMEFON Residue file name: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ AggregateFLturf2app_ 7242006. R98 Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 10: 04: 48/ 8 Reference dose ( aRfD) = 0.0034 mg/ kg bw/ day Comment: Triadimefon + Triadimenol [ food + FL turf 2 appl max]  RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter # 1 Param # 2 Param # 3 Comment # Code       1 6 Apple, NB or PB 6 21 2006. rdf 2 6 Apple, B  6 21 2006. rdf 3 6 GrapesPB 6 21 2006. rdf 4 6 Pear, NB or PB 6 21 2006. rdf 5 6 Pineapples, FT 6 21 2006. rdf 6 6 new FDA Raspberry 06 29 2006. rdf 7 6 Banana, PBNB FT 6 21 2006. rdf 8 6 FLturf2applmaxDW_ triadimefon. rdf EPA Crop Food Name Def Res Adj. Factors RDL Comment Code Grp ( ppm) # 1 # 2 Pntr         95000230 O Banana 0.030000 1.000 1.000 7 95000231 O Banana babyfood 0.030000 1.000 1.000 7 95000240 O Banana, dried 0.030000 3.900 1.000 Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 14 of 21 95000241 O Banana, dried babyfood 0.030000 3.900 1.000 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 2.100 1.000 15001200 15 Corn, field, flour 0.050000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 15001230 15 Corn, field, starch 0.050000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.000 1.000 15001241 15 Corn, field, syrup babyfood 0.050000 1.000 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.050000 1.000 1.000 15001260 15 Corn, pop 0.050000 1.000 1.000 15001270 15 Corn, sweet 0.050000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.050000 1.000 1.000 95001280 O Cottonseed, oil 0.020000 1.000 1.000 95001281 O Cottonseed, oil babyfood 0.020000 1.000 1.000 15002310 15 Oat, bran 0.050000 2.100 1.000 15002320 15 Oat, flour 0.050000 1.000 1.000 15002321 15 Oat, flour babyfood 0.050000 1.000 1.000 15002330 15 Oat, groats/ rolled oats 0.050000 1.000 1.000 15002331 15 Oat, groats/ rolled oats babyfood 0.050000 1.000 1.000 95002790 O Pineapple 0.100000 1.000 1.000 5 95002791 O Pineapple babyfood 0.100000 1.000 1.000 5 95002800 O Pineapple, dried 0.100000 1.000 1.000 5 95002810 O Pineapple, juice 0.100000 1.000 1.000 5 95002811 O Pineapple, juice babyfood 0.100000 1.000 1.000 5 15003280 15 Rye, grain 0.050000 1.000 1.000 15003290 15 Rye, flour 0.050000 1.000 1.000 86010000 O Water, direct, all sources 0.010000 1.000 1.000 8 86020000 O Water, indirect, all sources 0.010000 1.000 1.000 8 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 2.100 1.000 Attachment 4: Acute Aggregate ( food + water) Residue Analysis U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID ACUTE Analysis for TRIADIMEFON ( 1994 98 data) Residue file: AggregateFLturf2app_ 7242006. R98 Adjustment factor # 2 used. Analysis Date: 07 25 2006/ 10: 09: 57 Residue file dated: 07 25 2006/ 10: 04: 48/ 8 Daily totals for food and foodform consumption used. MC iterations = 1000 MC list in residue file MC seed = 10 Run Comment: " Triadimefon + Triadimenol [ food + FL turf 2 appl max]" ===============================================================================

Summary calculations ( per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD       U. S. Population: 0.001106 32.52 0.002350 69.11 0.005541 162.98 All infants: 0.003190 93.82 0.007747 227.87 0.017654 519.24 Children 1 2 yrs: 0.001959 57.63 0.003817 112.26 0.008347 245.51 Children 3 5 yrs: 0.001765 51.92 0.003482 102.42 0.007469 219.69 Children 6 12 yrs: Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 15 of 21 0.001210 35.58 0.002400 70.58 0.005175 152.20 Youth 13 19 yrs: 0.000859 25.28 0.001802 53.00 0.004235 124.57 Adults 20 49 yrs: 0.000942 27.72 0.002085 61.33 0.004808 141.40 Adults 50+ yrs: 0.000921 27.10 0.001982 58.29 0.004131 121.50 Females 13 49 yrs: 0.000936 27.52 0.002087 61.39 0.004779 140.55 Attachment 5: Chronic Aggregate ( food only) Residue Input Data U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for TRIADIMEFON 1994 98 data Residue file: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ aggregatelFoodonly_ chronic7242006. R98 Adjust. # 2 used Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 09: 36: 52/ 8 Reference dose ( RfD) = 0.0034 mg/ kg bw/ day Comment: Chronic: Triadimefon + Triadimenol food only  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        95000230 O Banana 0.030000 1.000 1.000 95000231 O Banana babyfood 0.030000 1.000 1.000 95000240 O Banana, dried 0.030000 3.900 1.000 95000241 O Banana, dried babyfood 0.030000 3.900 1.000 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 2.100 1.000 15001200 15 Corn, field, flour 0.050000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 15001230 15 Corn, field, starch 0.050000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.000 1.000 15001241 15 Corn, field, syrup babyfood 0.050000 1.000 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.050000 1.000 1.000 15001260 15 Corn, pop 0.050000 1.000 1.000 15001270 15 Corn, sweet 0.050000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.050000 1.000 1.000 95001280 O Cottonseed, oil 0.020000 1.000 1.000 95001281 O Cottonseed, oil babyfood 0.020000 1.000 1.000 15002310 15 Oat, bran 0.050000 2.100 1.000 15002320 15 Oat, flour 0.050000 1.000 1.000 15002321 15 Oat, flour babyfood 0.050000 1.000 1.000 15002330 15 Oat, groats/ rolled oats 0.050000 1.000 1.000 15002331 15 Oat, groats/ rolled oats babyfood 0.050000 1.000 1.000 95002790 O Pineapple 0.079000 1.000 1.000 95002791 O Pineapple babyfood 0.079000 1.000 1.000 95002800 O Pineapple, dried 0.079000 5.000 1.000 95002810 O Pineapple, juice 0.079000 1.000 1.000 95002811 O Pineapple, juice babyfood 0.079000 1.000 1.000 15003280 15 Rye, grain 0.050000 1.000 1.000 15003290 15 Rye, flour 0.050000 1.000 1.000 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 2.100 1.000 Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 16 of 21 Attachment 6: Chronic Aggregate ( food only) Residue Analysis U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for TRIADIMEFON ( 1994 98 data) Residue file name: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ aggregatelFoodonly_ chronic7242006. R98 Adjustment factor # 2 used. Analysis Date 07 25 2006/ 09: 37: 36 Residue file dated: 07 25 2006/ 09: 36: 52/ 8 Reference dose ( RfD, Chronic) = .0034 mg/ kg bw/ day COMMENT 1: Chronic: Triadimefon + Triadimenol food only =============================================================================== Total exposure by population subgroup

Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.000194 5.7%

U. S. Population ( spring season) 0.000196 5.8% U. S. Population ( summer season) 0.000196 5.8% U. S. Population ( autumn season) 0.000190 5.6% U. S. Population ( winter season) 0.000192 5.6%

Northeast region 0.000190 5.6% Midwest region 0.000206 6.1% Southern region 0.000185 5.4% Western region 0.000197 5.8%

Hispanics 0.000203 6.0% Non hispanic whites 0.000193 5.7% Non hispanic blacks 0.000194 5.7% Non hisp/ non white/ non black 0.000178 5.2%

All infants (< 1 year) 0.000227 6.7% Nursing infants 0.000108 3.2% Non nursing infants 0.000272 8.0% Children 1 6 yrs 0.000467 13.7% Children 7 12 yrs 0.000309 9.1%

Females 13 19 ( not preg or nursing) 0.000177 5.2% Females 20+ ( not preg or nursing) 0.000128 3.8% Females 13 50 yrs 0.000157 4.6% Females 13+ ( preg/ not nursing) 0.000155 4.6% Females 13+ ( nursing) 0.000175 5.2%

Males 13 19 yrs 0.000229 6.7% Males 20+ yrs 0.000153 4.5% Seniors 55+ 0.000115 3.4%

Children 1 2 yrs 0.000493 14.5% Children 3 5 yrs 0.000471 13.9% Children 6 12 yrs 0.000323 9.5% Youth 13 19 yrs 0.000203 6.0% Adults 20 49 yrs 0.000154 4.5% Adults 50+ yrs 0.000117 3.4% Females 13 49 yrs 0.000147 4.3%

Attachment 7: Chronic Aggregate ( food + water) Residue Input Data Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 17 of 21 U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for TRIADIMEFON 1994 98 data Residue file: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ aggregatelFLturf2app_ chronic7242006. R98 Adjust. # 2 used Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 10: 14: 45/ 8 Reference dose ( RfD) = 0.0034 mg/ kg bw/ day Comment: Chronic: Triadimefon + Triadimenol food and drinking water[ FL turf 2 appl max]  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        95000230 O Banana 0.030000 1.000 1.000 95000231 O Banana babyfood 0.030000 1.000 1.000 95000240 O Banana, dried 0.030000 3.900 1.000 95000241 O Banana, dried babyfood 0.030000 3.900 1.000 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 2.100 1.000 15001200 15 Corn, field, flour 0.050000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 15001230 15 Corn, field, starch 0.050000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.000 1.000 15001241 15 Corn, field, syrup babyfood 0.050000 1.000 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.050000 1.000 1.000 15001260 15 Corn, pop 0.050000 1.000 1.000 15001270 15 Corn, sweet 0.050000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.050000 1.000 1.000 95001280 O Cottonseed, oil 0.020000 1.000 1.000 95001281 O Cottonseed, oil babyfood 0.020000 1.000 1.000 15002310 15 Oat, bran 0.050000 2.100 1.000 15002320 15 Oat, flour 0.050000 1.000 1.000 15002321 15 Oat, flour babyfood 0.050000 1.000 1.000 15002330 15 Oat, groats/ rolled oats 0.050000 1.000 1.000 15002331 15 Oat, groats/ rolled oats babyfood 0.050000 1.000 1.000 95002790 O Pineapple 0.079000 1.000 1.000 95002791 O Pineapple babyfood 0.079000 1.000 1.000 95002800 O Pineapple, dried 0.079000 5.000 1.000 95002810 O Pineapple, juice 0.079000 1.000 1.000 95002811 O Pineapple, juice babyfood 0.079000 1.000 1.000 15003280 15 Rye, grain 0.050000 1.000 1.000 15003290 15 Rye, flour 0.050000 1.000 1.000 86010000 O Water, direct, all sources 0.019633 1.000 1.000 86020000 O Water, indirect, all sources 0.019633 1.000 1.000 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 2.100 1.000 Attachment 8: Chronic Aggregate ( food + water) Residue Analysis U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for TRIADIMEFON 1994 98 data Residue file: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ aggregatelFLturf2app_ chronic7242006. R98 Adjust. # 2 used Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 10: 14: 45/ 8 Reference dose ( RfD) = 0.0034 mg/ kg bw/ day Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 18 of 21 Comment: Chronic: Triadimefon + Triadimenol food and drinking water[ FL turf 2 appl max]  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        95000230 O Banana 0.030000 1.000 1.000 95000231 O Banana babyfood 0.030000 1.000 1.000 95000240 O Banana, dried 0.030000 3.900 1.000 95000241 O Banana, dried babyfood 0.030000 3.900 1.000 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 2.100 1.000 15001200 15 Corn, field, flour 0.050000 1.000 1.000 15001201 15 Corn, field, flour babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 15001211 15 Corn, field, meal babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 15001230 15 Corn, field, starch 0.050000 1.000 1.000 15001231 15 Corn, field, starch babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.000 1.000 15001241 15 Corn, field, syrup babyfood 0.050000 1.000 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 15001251 15 Corn, field, oil babyfood 0.050000 1.000 1.000 15001260 15 Corn, pop 0.050000 1.000 1.000 15001270 15 Corn, sweet 0.050000 1.000 1.000 15001271 15 Corn, sweet babyfood 0.050000 1.000 1.000 95001280 O Cottonseed, oil 0.020000 1.000 1.000 95001281 O Cottonseed, oil babyfood 0.020000 1.000 1.000 15002310 15 Oat, bran 0.050000 2.100 1.000 15002320 15 Oat, flour 0.050000 1.000 1.000 15002321 15 Oat, flour babyfood 0.050000 1.000 1.000 15002330 15 Oat, groats/ rolled oats 0.050000 1.000 1.000 15002331 15 Oat, groats/ rolled oats babyfood 0.050000 1.000 1.000 95002790 O Pineapple 0.079000 1.000 1.000 95002791 O Pineapple babyfood 0.079000 1.000 1.000 95002800 O Pineapple, dried 0.079000 5.000 1.000 95002810 O Pineapple, juice 0.079000 1.000 1.000 95002811 O Pineapple, juice babyfood 0.079000 1.000 1.000 15003280 15 Rye, grain 0.050000 1.000 1.000 15003290 15 Rye, flour 0.050000 1.000 1.000 86010000 O Water, direct, all sources 0.019633 1.000 1.000 86020000 O Water, indirect, all sources 0.019633 1.000 1.000 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 2.100 1.000 Attachment 9 Acute Aggregate ( Water only) Residue Input Data U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID Acute analysis for TRIADIMEFON Residue file name: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ AggregateWateronly_ 7242006. R98 Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 09: 41: 04/ 8 Reference dose ( aRfD) = 0.0034 mg/ kg bw/ day Comment: Triadimefon + Triadimenol [ drinking water only]  RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter # 1 Param # 2 Param # 3 Comment # Code       1 6 Apple, NB or PB 6 21 2006. rdf 2 6 Apple, B  6 21 2006. rdf Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 19 of 21 3 6 GrapesPB 6 21 2006. rdf 4 6 Pear, NB or PB 6 21 2006. rdf 5 6 Pineapples, FT 6 21 2006. rdf 6 6 new FDA Raspberry 06 29 2006. rdf 7 6 Banana, PBNB FT 6 21 2006. rdf 8 6 FLturf2applmaxDW_ triadimefon. rdf EPA Crop Food Name Def Res Adj. Factors RDL Comment Code Grp ( ppm) # 1 # 2 Pntr         86010000 O Water, direct, all sources 0.100000 1.000 1.000 8 86020000 O Water, indirect, all sources 0.100000 1.000 1.000 8 Attachment 10 Acute Aggregate ( Water only) Residue Analysis U. S. Environmental Protection Agency Ver. 2.02 DEEM FCID ACUTE Analysis for TRIADIMEFON ( 1994 98 data) Residue file: AggregateWateronly_ 7242006. R98 Adjustment factor # 2 used. Analysis Date: 07 25 2006/ 09: 45: 07 Residue file dated: 07 25 2006/ 09: 41: 04/ 8 Daily totals for food and foodform consumption used. MC iterations = 1000 MC list in residue file MC seed = 10 Run Comment: " Triadimefon + Triadimenol [ drinking water only] " ===============================================================================

Summary calculations ( per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD       U. S. Population: 0.000812 23.87 0.002064 60.70 0.005235 153.96 All infants: 0.002904 85.42 0.007494 220.43 0.017596 517.54 Children 1 2 yrs: 0.001235 36.31 0.003156 92.83 0.007657 225.20 Children 3 5 yrs: 0.001148 33.76 0.002896 85.17 0.006935 203.96 Children 6 12 yrs: 0.000789 23.21 0.001990 58.52 0.004794 141.01 Youth 13 19 yrs: 0.000602 17.69 0.001582 46.54 0.004005 117.80 Adults 20 49 yrs: 0.000763 22.43 0.001908 56.12 0.004574 134.54 Adults 50+ yrs: 0.000789 23.21 0.001857 54.62 0.003999 117.61 Females 13 49 yrs: 0.000764 22.47 0.001921 56.51 0.004562 134.18 Attachment 11 Chronic Aggregate ( Water only) Residue Input Data U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for TRIADIMEFON 1994 98 data Residue file: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ AggregateWateronly_ 7242006chronic. R98 Adjust. # 2 used Analysis Date 07 25 2006 Residue file dated: 07 25 2006/ 09: 52: 02/ 8 Reference dose ( RfD) = 0.0034 mg/ kg bw/ day Comment: Chronic: Triadimefon + Triadimenol [ drinking water only]  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        86010000 O Water, direct, all sources 0.019633 1.000 1.000 86020000 O Water, indirect, all sources 0.019633 1.000 1.000 Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 20 of 21 Attachment 12 Chronic Aggregate ( Water only) Residue Analysis U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for TRIADIMEFON ( 1994 98 data) Residue file name: C:\ Documents and Settings\ spiper\ SPIPER\ triadimenol\ AggregateWateronly_ 7242006chronic. R98 Adjustment factor # 2 used. Analysis Date 07 25 2006/ 09: 52: 41 Residue file dated: 07 25 2006/ 09: 52: 02/ 8 Reference dose ( RfD, Chronic) = .0034 mg/ kg bw/ day COMMENT 1: Chronic: Triadimefon + Triadimenol [ drinking water only] =============================================================================== Total exposure by population subgroup

Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.000414 12.2%

U. S. Population ( spring season) 0.000410 12.1% U. S. Population ( summer season) 0.000445 13.1% U. S. Population ( autumn season) 0.000400 11.8% U. S. Population ( winter season) 0.000400 11.8%

Northeast region 0.000377 11.1% Midwest region 0.000418 12.3% Southern region 0.000393 11.6% Western region 0.000474 13.9%

Hispanics 0.000470 13.8% Non hispanic whites 0.000404 11.9% Non hispanic blacks 0.000393 11.6% Non hisp/ non white/ non black 0.000507 14.9%

All infants (< 1 year) 0.001357 39.9% Nursing infants 0.000503 14.8% Non nursing infants 0.001681 49.4% Children 1 6 yrs 0.000578 17.0% Children 7 12 yrs 0.000376 11.1%

Females 13 19 ( not preg or nursing) 0.000291 8.6% Females 20+ ( not preg or nursing) 0.000413 12.1% Females 13 50 yrs 0.000400 11.8% Females 13+ ( preg/ not nursing) 0.000402 11.8% Females 13+ ( nursing) 0.000573 16.9%

Males 13 19 yrs 0.000304 9.0% Males 20+ yrs 0.000371 10.9% Seniors 55+ 0.000406 11.9%

Children 1 2 yrs 0.000615 18.1% Children 3 5 yrs 0.000575 16.9% Children 6 12 yrs 0.000397 11.7% Youth 13 19 yrs 0.000299 8.8% Adults 20 49 yrs 0.000386 11.4% Adults 50+ yrs 0.000406 12.0% Females 13 49 yrs 0.000385 11.3%

Attachment 13: Short term Aggregate Calculations Triadimefon & Triadimenol Aggregate Risk Assessment  RED DP Barcode: 331455 Page 21 of 21 Short Term Aggregate Calculations: short term aggregate for the " residential M/ L/ A WP hose end azalea" scenario which has an MOE of 1100 ( dermal+ inhalation) is calculated using the chronic dietary aggregate ( food + water) with an exposure number for the U. S. general population = 0.000607 mg/ kg/ day or an MOE = 5600. The resulting short term aggregate has an MOE of 920. The " residential M/ L/ A WP low P hand wand GH ornamentals" with a dermal+ inhalation MOE of 1700 plus the chronic food + water number noted above. The resulting short term aggregate has an MOE of 1300.

Short term aggregate ( toddler) using post application exposure to sod turf scenarios: the MOE ( combined) at a sod preharvest interval of 15 days was 1100; MOE was < 1000 at 14 days. Calculation: using the 1100 MOE and the chronic dietary ( food + water) exposure for " Children 1 2 yrs" which had an exposure number of 0.001108 mg/ kg/ day or an MOE of 3100. This dietary assessment subgroup is the best match with toddlers as well as being protective of other children's population subgroups capable of " toddling." The resulting short term aggregate has an MOE was 810.

The calculated number of days necessary to result in a short term aggregate has an MOE of

1000. On day 17, the combined MOE's for toddlers on turf at the rate of 2.7 lb a. i. / A rate is 1700. When that is aggregated with the 3100 MOE, the aggregate is 1100.

The individual MOE's are: a) Hand To Mouth = 2500; b) Object To Mouth = 10,000; c) Soil = 31,000; Dermal = 11,000 Day 16 does not pass  it is 920 with the total aggregate.


[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Page 5858]
[FR Doc No: 2013-01704]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Operations
Specifications

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
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DATES: Written comments should be submitted by March 29, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0749
    Title: Operations Specifications.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: This rule clarifies and standardizes the rules for
applications by foreign air carriers and foreign persons for operations
specifications issued under 14 CFR part 129 and establishes new
standards for amendment, suspension and termination of those operations
specifications. This final rule also applies to foreign air carriers
and foreign persons operating U.S.-registered aircraft in common
carriage solely outside the United States. This action was necessary to
update the process for issuing operations specifications, and it
establishes a regulatory basis for current practices, such as amending,
terminating, and suspending operations specifications.
    Respondents: Approximately 25 new applicants for operations
specifications annually
    Frequency: Five FSDOs will receive approximately five applications
per year.
    Estimated Average Burden per Response: 3 hours.
    Estimated Total Annual Burden: 75 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on January 22, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-01704 Filed 1-25-13; 8:45 am]
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[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Notices]
[Page 54749]
[FR Doc No: 2022-19318]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. 2013-0259]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Advisory
Circular: Reporting of Laser Illumination of Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval renew information collection.
Advisory Circular 70-2A provides guidance to civilian air crews on the
reporting of laser illumination incidents and recommended mitigation
actions to be taken in order to ensure continued safe and orderly
flight operations.

DATES: Written comments should be submitted by November 1, 2022.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Barbara Hall by email at: Barbara Hall, Federal Aviation
Administration, ASP-110, 10101 Hillwood Parkway, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Barbra Hall by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0698
    Title: Advisory Circular (AC): Reporting of Laser Illumination of
Aircraft.
    Form Numbers: Advisory Circular 70- 2A, Reporting of Laser
Illumination of Aircraft.
    Type of Review: Renewal of an information collection.
    Background: Advisory Circular 70-2A provides guidance to civilian
air crews on the reporting of laser illumination incidents and
recommended mitigation actions to be taken in order to ensure continued
safe and orderly flight operations. Information is collected from
pilots and aircrews that are affected by an unauthorized illumination
by lasers. The requested reporting involves an immediate broadcast
notification to Air Traffic Control (ATC) when the incident occurs, as
well as a broadcast warning of the incident if the aircrew is flying in
uncontrolled airspace. In addition, the AC requests that the aircrew
supply a written report of the incident and send it by fax or email to
the Washington Operations Control Complex (WOCC) as soon as possible.
    Respondents: Approximately 1,100 pilots and crewmembers.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 10 minutes.
    Estimated Total Annual Burden: 183 hours.

    Issued in Washington, DC, on September 1, 2022.
Sandra Ray,
Aviation Safety Inspector, Aviation Safety, Safety Standards, AFS-260.
[FR Doc. 2022-19318 Filed 9-6-22; 8:45 am]
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