[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Pages 71108-71109]
[FR Doc No: 2010-29306]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1940-024]

Wisconsin Public Service Corporation; Notice of Application for
Amendment of License and Soliciting Comments, Motions To Intervene, and
Protests

November 12, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application to amend project boundary.
    b. Project No.: 1940-024.
    c. Date Filed: June 30, 2010.
    d. Applicant: Wisconsin Public Service Corporation.
    e. Name of Project: Tomahawk Hydroelectric Project.
    f. Location: Wisconsin River in Lincoln County, Wisconsin.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Shawn Puzen, telephone:<PHONE_NUMBER>.
    i. FERC Contact: Mark Carter, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: December 13, 2010.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Please include the project number (P-1940-024) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, it
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Application: The licensee requests Commission
approval to amend the project boundary to remove lands not needed for
project purposes (e.g., lands that contain residential homes and
seasonal cottages), and add lands that are necessary for project
purposes (e.g., wetland areas, land in the 100-year floodplain, etc.).
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (P-1940) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, call 1-866-
208-3676 or e-mail<EMAIL_ADDRESS>for TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
Bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the amendment application.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in

accordance with 18 CFR 4.34(b) and 385.2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-29306 Filed 11-19-10; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	June  10, 2009

SUBJECT:	Triticonazole Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for a Section 3 Registration Action for Seed Treatment of Cereals.

PC Code:  125620

DP Barcode:  366041

Decision No.:  399232

Registration No.:  7969-xxx

Petition No.:  8F7420

Regulatory Action:  Sec. 3 Registration

Risk Assessment Type:  Single Chemical/Aggregate

Case No.:  NA

TXR No.:  NA

CAS No.:  131983-72-7

MRID No.:  NA

40 CFR:  180.583

FROM:	Amelia M. Acierto, Chemist

Risk Assessment Branch 3 (RAB3)

Health Effects Division (HED) (7509P)

THROUGH:  David Soderberg, Chemist

	Nancy Dodd, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

						and

Paula Deschamp, Branch Chief

Risk Assessment Branch 3 (RAB3)

Health Effects Division (HED) (7509P)

TO:	Nancy Tsaur, Risk Assessor

Risk Assessment Branch 3 (RAB3)

Health Effects Division (HED) (7509P)

		and

Shaja Joyner (RM Team # 20)

Fungicide Branch

Registration Division (RD) (7505P)

Executive Summary

ion Model (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 to support a Section 3 registration request for triticonazole use as a seed treatment on cereal grains (Crop Group 15, except rice).

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

The acute analyses assumed that triticonazole residues are present in all registered and proposed food commodities at tolerance levels and that 100% of all commodities are treated.  All processing factors were set to 1, based on the results of processing studies indicating that residues of triticonazole in processed commodities would not exceed the  raw agricultural commodity (RAC) tolerances.

Drinking water residues were incorporated directly into the dietary assessment using the EDWCs for triticonazole in surface water, generated using the PRISM/EXAMS models.  For the acute assessment, the 1-in-10 year annual peak concentration of 75.5 ppb was used.  The water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The acute dietary (food and drinking water) exposure assessment for females 13-49 years was performed separately, since the acute toxicological endpoint of concern was different from that identified for the general U.S. population (see Table 1).  Based on the assumptions described above, the most highly exposed population subgroup is females 13-49 years old.  However, the exposure is well below HED’s level of concern at the 95th percentile of exposure.  Combined acute dietary exposure from food and drinking water is <1% of the acute Population Adjusted Dose (aPAD) for females 13-49 years old.  For the general U.S. population and for all infants <1 year old, the exposure is  also <1 of the aPAD.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic analyses assumed that triticonazole residues are present in all registered and proposed food commodities at tolerance levels and that 100% of all commodities are treated.  All processing factors were set to 1, based on the results of processing studies indicating that residues of triticonazole in processed commodities would not exceed the  raw agricultural commodity (RAC) tolerances.

Drinking water residues were incorporated directly into the dietary assessment using the EDWCs for triticonazole in surface water, generated using the PRISM/EXAMS models.  For the chronic assessment, the 1-in-10 annual mean concentration of 32.8 ppb was used.  The water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

Chronic dietary exposure estimates for food and drinking water combined are also well below HED’s level of concern.  The dietary exposure is estimated <1% of the cPAD) for the general U.S. population and 1.4% of the cPAD for all infants (<1 year old), the population subgroup with the highest estimated chronic dietary exposure to triticonazole.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Triticonazole is classified as “Not likely to be Carcinogenic to Humans”, therefore, the quantification of carcinogenic potential is not applicable  (TXR Number 0054249, 4/12/2006).

 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 the 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 the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors..

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

The most recent dietary risk assessment for triticonazole was conducted by Sarah Winfield (11/28/2006, DP#334039).

Residue Information

Triticonazole Use:

BASF Crop Protection has proposed use of triticonazole as a seed treatment of the cereal grains in Crop Group 15, except rice and cereal grains in Crop Group 16, except rice.  In connection with that use, HED is recommending tolerances of  0.05 ppm for cereal grains (Crop Group 15, except rice) and 0.25 ppm for the forage, fodder and straw of cereal grains (Crop Group 16, except rice) (DP#325956, A. Acierto, 6/9/2009).

Permanent tolerances have been established in 40 CFR §80.583 (a) for residues of the fungicide triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(H-1,2,4-triazol- 1-ylmethyl)cyclopentanol, from the treatment of seed prior to planting in or on barley grain, hay, and straw, and wheat forage, grain, hay, and straw at 0.05 ppm.

No livestock tolerances have been established.  Based on the available cow and poultry metabolism studies, and low levels of residues found in the cereal grain (corn, rice, sorghum and wheat) field trials, there is no reasonable expectation that quantifiable residues of triticonazole will occur in livestock commodities [40 CFR §180.6(a)(3)].

No separate tolerances have been established for processed commodities.  Processing data for corn, sorghum, and wheat showed no concentration of triticonazole in processed commodities following seed treatment at 5x the maximum proposed seed treatment rate.

As determined by the HED’s Metabolism Assessment Review Committee  (MARC) in a meeting on 5/1/2001, the residue of concern in barley, wheat, and livestock for seed treatment uses  is triticonazole.  The available metabolism studies supporting seed treatment uses on barley and wheat may be extended to include seed treatment uses on all cereal grains.

The residues of concern in drinking water (for risk assessment) are triticonazole and its transformation products since environmental data suggests that they have similar physical,, chemical,and toxicological properties and, thus, are expected to be similar to triticonazole in persistence and toxicity.  Triticonazole may be transformed in the environment via 1) E-Z isomerization (in the presence of sunlight), 2) hydroxylation, or 3) stepwise mineralization and potential formation of free triazole.  Triticonazole dissipation is expected to occur primarily via dilution in the environment.  Degradation of the parent or further degradation of the putative toxic degradates is not expected to be significant in the environment; degradation pathways have not been identified.

The requested seed treatment uses of triticonazole did not result in increase dietary exposure estimate for free triazole or conjugated triazoles.  Therefore, the last dietary exposure analyses for the triazole metabolites (M. Doherty, 6 Oct. 2009) have not changed.

Residue Data used for the Acute and Chronic Assessments

The acute and chronic dietary analysis assumed that triticonazole residues are present in/on all registered commodities at tolerance levels and that 100% of all commodities are treated.  All processing factors were set to 1x, based on the results of processing studies indicating that residues of triticonazole in processed commodities would not exceed the raw agricultural commodity (RAC) tolerances.

Although seed treatment use of triticonazole on cereal grain, group 16 was proposed, the proposed use does not impact, nor result in raw agricultural commodities for human consumption.  The food residue data used in the acute and chronic dietary analyses are summarized in Table 1.

Table 1.  Residue Data Used in the Acute and Chronic Dietary Analyses for Triticonazole

Commodity	Tolerance	Percent Crop Treated	Processing Factors

Cereal Grains,  Crop Group 15, except rice

0.05 ppm

100

NA1

1Not applicable

 Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: “Tier II Drinking Water Assessment for the Triticonazole Section 3 Turf Use” (C. Sutton, DP#358615, 3/24/09) and incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”.

The Environmental Effects Division determined that the maximum estimated Drinking Water Concentration (EDWCs) for the seed treatment use of triticonazole on cereal grain crop group 15 (except rice, are much lower than the EDWCs determined for the use on turfgrass. Therefore, the EDWCs for turfgrass were used in this dietary assessment as described below.

EFED calculated screening level surface water and ground water estimates for triticonazole using the computer models PRZM/EXAMS (surface water) and SCI-GROW2 (groundwater) respectively.  The drinking water models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

Table 2.  Tier II estimated drinking water concentrations (EDWCs) resulting from applications of triticonazole.

Drinking water source (model)	Use

(modeled rate)	1-in-10 year acute (ppb)	1-in-10 year chronic (ppb)	30- year average (ppb)

Surface water (PRZM/EXAMS)	Turfgrass

(3.45 lb a.i./A/yr)	75.5	32.8	21.4

Groundwater (SCIGROW)	Turfgrass

(3.45 lb a.i./A/yr)	5.7	<5.7	<5.7

For the purpose of this dietary assessment, HED used the highest calculated screening EDWCs for surface water: 75.5 ppb for the acute analysis and 32.2 ppb for the chronic analysis.  This approach may significantly overestimate dietary exposure to triticonazole from drinking water; however, since estimated aggregate food and drinking water exposures using this approach are well below the acute and chronic levels of concern, additional refinements were not deemed necessary.  For both the acute and chronic analyses, the drinking water EDWC was incorporated directly in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

IV.	DEEM-FCID™ Program and Consumption Information

Triticonazole acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, 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 (no significance differences were identified for triticonazole).

V.	Toxicological Information

The risk assessment team confirmed endpoints that were selected previously.  On April 5, 2001, the HED Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for triticonazole with regard to the acute and chronic RfDs and the toxicological endpoint selection for use as appropriate in occupational/residential exposure/risk assessments.  The potential for increased susceptibility of infants and children from exposure to triticonazole was also evaluated as required by the FQPA of 1996 (TXR Number 0014698, 10/11/2001, A. Assaad).  Additionally, the FQPA Safety Factor Committee met on February 11, 2002 to evaluate the hazard and exposure data for triticonazole and recommended that the FQPA Safety Factor be removed (1x) in assessing the risk posed by this chemical (HED DOC. NO. 0050801, 6/13/2002) because the degree of concern for pre-natal and post-natal toxicity is low, and there are no residual uncertainties regarding the available data in rats and mice.  The doses and toxicological endpoints selected for various exposure scenarios are summarized in Table 3.  On April 12, 2006, the carcinogenic potential of triticonazole was re-evaluated by the Cancer Assessment Review Committee (CARC).  In accordance with the EPA’s Final Guidelines for Carcinogen Risk Assessment (March, 2005), the CARC classified triticonazole as “Not likely to be Carcinogenic to Humans,” therefore, the quantification of carcinogenic potential is not applicable (TXR Number 0054249, 4/12/2006).

Table 3.  Summary of Toxicological Doses and Endpoints for Triticonazole for Use in Dietary Exposure Risk Assessments

Exposure/

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

Acute Dietary (General Population, including Infants and Children) NOAEL= 400 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 4 mg/kg/day

aPAD =4 mg/kg/day	Acute Neurotoxicity - Rat

LOAEL = 2000 mg/kg/day based on increased motor activity in both sexes

Acute Dietary

(Females 13-49 years of age)	NOAEL = 50 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 0.5 mg/kg/day	Developmental - Rabbit

LOAEL = 75 mg/kg/day based on cranial variations, abortion, and increased pre- and post-implantation losses assumed to occur following a single dose (developmental toxicity)

Chronic Dietary (All Populations)	NOAEL= 17.4 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD = 0.17

mg/kg/day

cPAD = 0.17 mg/kg/day	Carcinogenicity - Mouse

LOAEL of ~ 200 mg/kg/day based on decreased body weight gain and liver toxicity

[LOAEL=202/209.5 mkd for males/females]

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be Carcinogenic to Humans” based on no evidence of carcinogenicity from studies in rats and mice.

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 aPAD or cPAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 below 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.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The results of the acute dietary exposure analysis are reported in Table 4 below.  The acute dietary (food  and drinking water) exposure assessment was performed separately for females 13-49 yeas old since the acute endpoint of concern is different from the acute endpoint identified for the general U.S. population (Table 3).  Based on the assumptions described in Sections II and V, the most highly exposed population subgroup is female 13-49 years old, although the exposure is well below HED’s level of concern at the 95th percentile of exposure.  Combined acute dietary exposure from food and drinking water is estimated at 003813 mg/kg/day, equivalent to <1% of the acute Population Adjusted Dose (aPAD) for female 13-49 years old.

Triticonazole acute dietary (food and drinking water) exposures at the 95th percentile for the general U.S. population and each of the population subgroups are also well below HED’s level of concern.  Dietary exposure was estimated at 0.004192 mg/kg/day, equivalent to <1% of the aPAD for the general U.S. population and  0.015052 mg/kg/day, equivalent to <1% of the aPAD for all infants (<1 year old).

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary exposure analysis are reported in Table 4 below.  Chronic dietary exposure estimates for food and water combined are well below HED’s level of concern.  The dietary exposure is estimated at 0.000865 mg/kg/day (<1% of the cPAD) for the general U.S. population and 0.002431 mg/kg/day (1.4% of the cPAD) for all infants (<1 year old), the most highly exposed population subgroup.

Table 4.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Triticonaozle

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD*	Dietary Exposure

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population

0.004192

<1.0

0.000865

<1.0	N/A	N/A

All Infants (< 1 year old)

0.015052	<1.0

(0.38)

0.002431

1.4

Children 1-2 years old

0.006674

<1.0

0.001422

<1.0

Children 3-5 years old

0.006171

<1.0

0.001376

<1.0

Children 6-12 years old

0.004301

<1.0

0.000959

<1.0

Youth 13-19 years old

0.003414

<1.0

0.000694

<1.0

Adults 20-49 years old

0.003806

<1.0

0.000787

<1.0

Adults 50+ years old

0.003426

<1.0

0.000781

<1.0

Females 13-49 years old

0.003813	<1.0

(0.76)

0.000777

<1.0

* The acute endpoint for females 13-49 years old is different from the acute endpoint identified for all the other subpopulations. The bolded values indicate the highest exposed population for each type of risk assessment.

VII.	Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk estimates are highly conservative since these assumes that 100% of the crops are treated with triticonazole and that residues are present at tolerance levels even though actual residues from field trials were less than the tolerance level (0.05 ppm). In addition, drinking water exposure estimates were based on screening level estimates generated by the PRZM-EXAMS model which resulted to higher point estimates and therefore are more protective than the SCIGROW model.  Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water concentrations.  However, since estimated exposures and risks using conservative assumptions are well below HED’s level of concern, such refinement is not warranted.

VIII.	Conclusions

 dietary exposure analyses using DEEM-FCID™ indicate that acute (at the 95th percentile) and chronic dietary exposures to triticonazole are well below HED’s level of concern for seed treatment use of the fungicide on the cereal grain crop group 15, except rice.  The assessments can be considered highly conservative as they assume all the subject crops are treated and bear residues at the tolerance level.  Actual exposure is likely to be much lower.

IX.		List of Attachments

	Attachment 1: Acute Dietary (Food Plus Water) Residue Input file.

	Attachment 2: Acute Dietary (Food plus Water) Results file for Female 13-49 years old.

Attachment 3: Acute Dietary (Food plus Water) Results file for the General U.S.Population

	Attachment 4: Chronic Dietary (Food plus Water) Residue Input file.

	Attachment 5: Chronic Dietary (Food plus Water) Results file.

Attachment 1: Acute Dietary (Food plus Water) Residue Input file.

U.S. Environmental Protection Agency                                Ver. 2.02

DEEM-FCID Acute analysis for TRITICONAZOLE

Residue file name: C:\Documents and Settings\aacierto\My Documents\DEEM-FCID Files\deemfcid\Deemfcid\Triticonazole\triticonazoleAcute.R98

Analysis Date 06-16-2009            Residue file dated: 06-16-2009/11:09:58/8

Reference dose: aRfD = 4 mg/kg bw/day  NOEL = 400 mg/kg bw/day

Comment: cereal grain seed treatment

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

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   1.000  1.000

15000650 15   Buckwheat                          0.050000   1.000  1.000

15000660 15   Buckwheat, flour                   0.050000   1.000  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

15002260 15   Millet, grain                      0.050000   1.000  1.000

15002310 15   Oat, bran                          0.050000   1.000  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

15003280 15   Rye, grain                         0.050000   1.000  1.000

15003290 15   Rye, flour                         0.050000   1.000  1.000

15003440 15   Sorghum, grain                     0.050000   1.000  1.000

15003450 15   Sorghum, syrup                     0.050000   1.000  1.000

15003810 15   Triticale, flour                   0.050000   1.000  1.000

15003811 15   Triticale, flour-babyfood          0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.075500   1.000  1.000

86020000 O    Water, indirect, all sources       0.075500   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   1.000  1.000

Attachment 2: Acute Dietary (Food plus Water) Results file for Female 13-49 years old.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for TRITICONAZOLE                       (1994-98 data)

Residue file: triticonazoleAcute.R98          Adjustment factor #2 NOT used.

Analysis Date: 06-16-2009/11:14:47  Residue file dated: 06-16-2009/11:09:58/8

NOEL (Acute) = 400.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "cereal grain seed treatment"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure  % aRfD    MOE   Exposure  % aRfD    MOE   Exposure  % aRfD    MOE  ---------- ------- -------- --------- ------- -------- ---------- ------- ---

Females 13-49 yrs:

  0.003813   0.10  104905  0.006039    0.15   66239  0.010651   0.27   37554

Attachment 3: Acute Dietary (Food plus Water) Results file for the General U.S. Population

U.S. Environmental Protection Agency                                Ver. 2.02

DEEM-FCID ACUTE Analysis for TRITICONAZOLE                    (1994-98 data)

Residue file: triticonazoleAcute.R98           Adjustment factor #2 NOT used.

Analysis Date: 06-16-2009/11:34:26  Residue file dated: 06-16-2009/11:09:58/8

NOEL (Acute) = 400.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "cereal grain seed treatment"

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

Summary calculations (per capita):

      95th Percentile            99th Percentile           99.9th Percentile

 Exposure  % aRfD    MOE   Exposure  % aRfD    MOE   Exposure  % aRfD     MOE

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

U.S. Population:

  0.004192    0.10   95430  0.007666   0.19   52180  0.015105    0.38   26481

All infants:

  0.015052    0.38   26574  0.021515   0.54   18591  0.038065    0.95   10508

Children 1-2 yrs:

  0.006674    0.17   59931  0.011069   0.28   36137  0.015453    0.39   25885

Children 3-5 yrs:

  0.006171    0.15   64815  0.009504   0.24   42086  0.015442    0.39   25902

Children 6-12 yrs:

  0.004301    0.11   92992  0.006979   0.17   57315  0.009335    0.23   42848

Youth 13-19 yrs:

  0.003414    0.09  117156  0.005572   0.14   71783  0.009812    0.25   40767

Adults 20-49 yrs:

  0.003806    0.10  105090  0.006271   0.16   63789  0.011201    0.28   35709

Adults 50+ yrs:

  0.003426    0.09  116767  0.004894   0.12   81728  0.007830    0.20   51084

Attachment 4: Chronic Dietary (Food plus Water) Residue Input file.

U.S. Environmental Protection Agency                               Ver. 2.00

DEEM-FCID Chronic analysis for TRITICONAZOLE                     1994-98 data

Residue file: C:\Documents and Settings\aacierto\My Documents\DEEM-FCID Files\deemfcid\Deemfcid\Triticonazole\triticonazoleChronic.R98                                                     Adjust. #2 NOT used

Analysis Date 06-16-2009            Residue file dated: 06-16-2009/10:41:14/8

Reference dose (RfD) = 0.174  (NOEL) = 17.4 mg/kg bw/day

Comment:cereal grain seed treatment

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

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   1.000      1.000

15000650 15   Buckwheat                          0.050000   1.000      1.000

15000660 15   Buckwheat, flour                   0.050000   1.000      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

15002260 15   Millet, grain                      0.050000   1.000      1.000

15002310 15   Oat, bran                          0.050000   1.000      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

15003280 15   Rye, grain                         0.050000   1.000      1.000

15003290 15   Rye, flour                         0.050000   1.000      1.000

15003440 15   Sorghum, grain                     0.050000   1.000      1.000

15003450 15   Sorghum, syrup                     0.050000   1.000      1.000

15003810 15   Triticale, flour                   0.050000   1.000      1.000

15003811 15   Triticale, flour-babyfood          0.050000   1.000      1.000

86010000 O    Water, direct, all sources         0.032800   1.000      1.000

86020000 O    Water, indirect, all sources       0.032800   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   1.000      1.000

Attachment 5: Chronic Dietary (Food plus Water) Results file.

U.S. Environmental Protection Agency                               Ver. 2.00

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

Residue file name: C:\Documents and Settings\aacierto\My Documents\DEEM-FCID Files\deemfcid\Deemfcid\Triticonazole\triticonazoleChronic.R98

                                               Adjustment factor #2 NOT used.

Analysis Date 06-16-2009/10:42:04   Residue file dated: 06-16-2009/10:41:14/8

Reference dose (RfD, Chronic) = .174 mg/kg bw/day

NOEL (Chronic) = 17.4 mg/kg bw/day

COMMENT 1: cereal grain seed treatment

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of   Percent

           Subgroup                       body wt/day   Exposure 1/  of RfD

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

U.S. Population (total)                     0.000865       20,111        0.5%

U.S. Population (spring season)             0.000862       20,192        0.5%

U.S. Population (summer season)             0.000920       18,907        0.5%

U.S. Population (autumn season)             0.000839       20,742        0.5%

U.S. Population (winter season)             0.000839       20,736        0.5%

Northeast region                            0.000801       21,724        0.5%

Midwest region                              0.000886       19,643        0.5%

Southern region                             0.000825       21,101        0.5%

Western region                              0.000965       18,023        0.6%

Hispanics                                   0.000962       18,080        0.6%

Non-hispanic whites                         0.000849       20,504        0.5%

Non-hispanic blacks                         0.000832       20,910        0.5%

Non-hisp/non-white/non-black                0.001002       17,361        0.6%

All infants (< 1 year)                      0.002431        7,158        1.4%

Nursing infants                             0.000909       19,147        0.5%

Non-nursing infants                         0.003008        5,784        1.7%

Children 1-6  yrs                           0.001366       12,736        0.8%

Children 7-12 yrs                           0.000912       19,088        0.5%

Females 13-19 (not preg or nursing)         0.000656       26,540        0.4%

Females 20+ (not preg or nursing)           0.000804       21,650        0.5%

/

D

v

–

—

¡

¢

¿

ß

%

0

4

5

:

D

š

¢

¾

hú

h‹

  h'

hú

h‹

h‹

퀀ࠂ䀇

퀀ࠂ䀇

	@

퀀ࠂ䀇

퀀ࠂ䀇

@

kd¡

hæm

hæm

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

$

@

$

@

$

@

$

@

emales 13-50 yrs                           0.000811       21,460        0.5%

Females 13+ (preg/not nursing)              0.000808       21,527        0.5%

Females 13+ (nursing)                       0.001103       15,774        0.6%

Males 13-19 yrs                             0.000728       23,915        0.4%

Males 20+ yrs                               0.000761       22,873        0.4%

Seniors 55+                                 0.000778       22,367        0.4%

Children 1-2 yrs                            0.001422       12,240        0.8%

Children 3-5 yrs                            0.001376       12,646        0.8%

Children 6-12 yrs                           0.000959       18,139        0.6%

Youth 13-19 yrs                             0.000694       25,069        0.4%

Adults 20-49 yrs                            0.000787       22,101        0.5%

Adults 50+ yrs                              0.000781       22,289        0.4%

Females 13-49 yrs                           0.000777       22,398        0.4%

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

Triticonazole	Dietary Exposure and Risk Assessment	DP Number: 366041

PC Code:  125260														    Decision Number: 399232

________________________________________________________________________ ______________

Page   PAGE  1  of   NUMPAGES  17