Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

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### UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND
POLLUTION PREVENTION



### MEMORANDUM

DATE : 28-March-2011

SUBJECT : Metconazole: Acute and Chronic Dietary (F ood and Drinking Water) Exposure and Risk Assessment for Residues in/on Vegetables, Tuberous & Corm, Subgroup 1C and Bushberry Subgroup 13-07B.

FROM: Amelia M. Acierto Risk Assessment Branch III (RAB3) Health Effects Division (HED) (7509P)

THROUGH: David Soderberg, Chemist Breann Hansen, Biologist Dietary Exposure Science Advisory Council (DESAC) HED (7509P)

and

Stephen Funk, Senior Science Advisor Risk Assessment Branch III (RAB3) Health Effects Division (HED) (7509P)

TO: Barry O’Keefe, Risk Assessor Risk Assessment Branch III (RAB3) Health Effects Division (HED) (7509P)

and

Barbara Madden, RM 05 Risk Integration, Minor Use, & Emergency Response Branch Registration Division (RD; 7505P) PC Code: 125619 DP Num: D387504
Decision No.: 436782 Registration Nos.: 59639-147
Petition No.: 0E7743 Regulatory Action: Section 3 Risk Assessment Type: Dietary Exposure Case No.: NA
TXR No.: NA CAS No.: 125116-23-6
MRID No.: NA 40 CFR: §180.617Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

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### Executive Summary

Acute and chronic dietary aggr egate dietary (food and drin king water) exposure and risk assessments were conducted using the Diet ary Exposure Evaluation Model (DEEM-FCID TM



### , Version 2.03), which uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 a nd 1998. The analyses were performed to support the proposed FIFRA sec. 3 amended regist ration of the fungicide metconazole (5-[(4- chlorophenyl)methyl]-2,2-dimethyl-1-(1 H -1,2,4-triazol-1-ylmethyl ) cyclopentanol]), on vegetables, tuberous and corm s ubgroup 1C and bushberry subgroup 13-7B.

Conservative acute and chronic dietary exposure assessments were conducted for all existing and proposed food uses of metconazole and dri nking water. Residues of the proposed food commodities were based on field trial data on the representative crops (potato and blueberry).
The conservative assessment assumed that metconazo le residues are present in all registered and proposed food commodities at tolerance levels a nd that 100% of the crops were treated. All processing factors for the proposed tuberous/cor m commodities were set to 1, based on the results of processing studies demonstrating that residues of metconazole in potato processed commodities would not exceed the raw agri cultural commodity (RAC) tolerance.

Estimated drinking water concentrations (EDW Cs) were provided by EFED (DP# 375778 and 380513, Khan, Faruque, Khan, et al, 16-Dec.-2010) and incorporated directly into the DEEM analyses. Both the acute and chronic analys es were conducted using estimated surface water residues generated using the PRZM/EXAMS models. Both the acute and chronic analyses were conducted using estimated surface water residue s generated using the PRZM/EXAMS models. For the acute assessment, the 1-in-10 year annua l peak concentration of 45.48 μg/Lwas used; for the chronic assessment, the 1-in-10 year annual mean concentration (non-cancer chronic) of 38.16 μg/L was used. Ground water sources were not included, as the EDWCs for this water source are minimal in comparison to those for surface water.

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

The acute dietary exposure assessment was perfor med for female 13-49 years old only since an acute endpoint was not identified for the Gene ral U.S. population. Estimated acute dietary exposure to metconazole from food and drinki ng water is below HED’s level of concern. Combined dietary exposure from fo od and drinking water at the 95 th 

### percentile of exposure is estimated to be 0.004578 mg/kg/day for females13-49 years old, equivalent to 3.8% of the acute Population Adjusted Dose (aPAD); therefore, is not of concern to HED (i.e., <100% aPAD)

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

Chronic dietary exposure estimates for food and drinking water combined are well below HED’s level of concern. Using EDWCs from the cran berry crop scenario, combined chronic dietary exposure is estimated at 0.002434 mg/kg/day for the general U.S. population (6.1% of the chronic Population Adjusted Dose (cPAD)) and 0.005026 mg/kg/day (12.6% of the cPAD) forMetconazole Dietary-Exposure and Risk Assessment DP #: D387504
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### children 1-2 years old, the popul ation subgroup with the highest estimated chronic dietary exposure to metconazole.

Cancer Exposure Results and Characterization

Metconazole was classified as “Not likely to be carcinogenic to humans;” therefore, a cancer dietary assessment was not performed.

I. Introduction

Dietary risk assessment incorporat es both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expresse d as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally co ncerned 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,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPAPEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (8/20/99).

The most recent dietary risk assessment for metconazole was conducted on 21-September-2008 (Memo, N. Dodd; DP# 350663).

II. Residue Information

Residues of Concern: The residues of concern for the to lerance expression a nd risk assessment for primary and rotational crops, except cereal grai ns is metconazole, residues of concern for the
risk assessment for the risk assessment for cerea l grain is metconazole and M11; residues of concern for the tolerance expression for livestock commodities is metconazole parent, residues
of concern for the risk assessment for livestock commodities are metconazole and its metabolites M1 and its glucuronic conjugate; M12; M31 a nd its glucuronic acid conjugate. (Memo, C. Olinger; DP# 348234, 11-February-2008).

Established Tolerances: Tolerances for residues of metc onazole are established under 40 CFR §180.617 and are expressed in terms of the fungicide metconazole or in terms of the fungicide metconazole, including its metabolites and degradates determined by measuring only
metconazole as the sum of its cis - and trans - isomers [40 CFR §180.617(a)(1) and (2).
Permanent tolerances have been established fo r a variety of raw agricultural and processed commodities including tree nuts, banana, barley, suga r beet, stone fruits, cereal grains, peanuts, soybean, canola, corn, and cotton commodities at tolerance levels ranging from 0.01-18 ppm. Tolerances for meat byproducts of cattle, goat, horse, and sheep, and egg are established at 0.04 ppm. Time-limited tolerances have also been established on sugarcane cane and molasses at 1.6Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
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### and 3.2 ppm, respectively, in connection with FIFRA § 18 emergency exemptions (49 CFR §180.617(b)) which is set to expire on 12/31/2011.

Recommended Tolerances:

Valent , USA Corporation and IR -4 have proposed new tolerances for metconazole on tuberous and corm vegetables subgroup 1C and bushberry subgroup 13-07B. The pr oposed tolerances are summarized below together with HED’s recommendatio ns based on review of field trial data (A. Acierto DP# 380990, 3/24/2011). The recommended tolerance of 0.40 ppm for bushberry is based on the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances. The tolerance spre adsheet was not used to calculate the tolerance for the tuberous and corm vegetables since the residues in potato (representativ e crop used) were <LOQ. HED recommended the tolerance of 0.04 ppm, reflecti ng the combined LOQs of the residues of metconazole isomers ( cis- and trans -isomers).

Table 1. Tolerance Summary for Metconazole.

Commodity Proposed Tolerance (ppm) Recommended Tolerance (ppm) Comments; Correct Commodity Definition Vegetable, tuberous and corm, subgroup 1C 0.02 0.04 Vegetable, tuberous and corm, subgroup 1C
Bushberry subgroup 13-
07B 0.35 0.40



### Processed Commodities

There are no processed commodities associ ated with bushberry (OPPTS 860.1000, Table 1). Potato processed commodities are potato flakes /granules, potato chips and potato wet peels. Processing studies were submitted from potato tu bers treated at exaggerated rate of 5x the recommended seasonal rate. Based on the very low (<LOQ of 0.02 ppm) metconazole residues from the RAC samples, residues are not expect ed to occur in the processed commodities. Therefore, the DEEM default pr ocessing factors were not used.

III. Drinking Water Data

Reference: DP# 375778 and 380513, Khan, Faruque, Khan, et al, 16-Dec.-2010.

The values used in the dietary risk assessmen t were provided by the Environmental Fate and Effects Division (EFED) in the following me mo: Drinking Water Exposure Assessment to
Establish Tolerances of Pare nt Metconazole for Tuberous/C orm (Subgroup 1C) and Bushberry (Subgroup 13-07BC) (DP# 375778 and 380513, Khan, Fa ruque, Khan, et al, 16-Dec.-2010). A Tier II drinking water assessment for the propos ed use on the tuberous/corm vegetables and bushberry were performed using PRZM/EXAMS modeling. Estimated concentrations of metconazole in drinking water from use on the new crops were provided by EFED and incorporated directly into the acute and chronic assessments.Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
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### Water residues were incorporated in the DEEM-FCID TM in the food categories “water, direct, all sources” and “water, i ndirect, all sources.”

The EDWCs are based on the maximum proposed ra tes specified on the la bel. For surface water, the EDWCs for the crops modeled in th e assessment did not exceed the acute EDWC of 45.48 ug/L for turf reported in the previ ous drinking water assessment (D340378, 2007). However, annual mean (chronic) concentration of 38.16 ug/L for cranberry scenario is higher than the previously reported EDWCs (31.25 ug/L) . Since the EDWC for the crops modeled in
the current assessment is lower than the acute ED WC for turf reported in the previous drinking water assessment, EFED recommended the use of the previous EDWC as follows:

45.48 μ/L for the 1 to 10 year a nnual peak concentration.(acute) 38.16 μ/L for the annual mean con centration (non-cancer chronic). \\\

The Environmental Fate and Effects Division (E FED) calculated screeni ng level surface water and ground water estimates fo r metconazole using linked PRZM/EXAMS models and the SCIGROW model, respectively. The drinking water models a nd their descriptions are available at
the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

IV. DEEM-FCIDTM Program and Consumption Information

Metconazole acute and chronic dietary exposur e assessments were conducted using DEEMFCIDTM, Version 2.03, which incorporates cons umption data from USDA’s CSFII, 1994-1996
and 1998. The 1994-96 and 1998 data are based on th e 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. a pples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using p ublicly available recipe translation files developed jointly by USDA /ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. populati on and within population subgroups, but for acute exposure assessment are retained as individual co nsumption events. Based on analysis of the 1994-96 and 1998 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to re port 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, yout h 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an esti mate of the residue level in each food or foodform (e.g., orange or orange juice) on the f ood commodity residue list is multiplied by the average daily consumption estimate for that food/f ood form to produce a residue intake estimate. The resulting residue intake estimate for each f ood/food form is summed w ith the residue intake
estimates for all other food/food forms on the comm odity residue list to arrive at the total average estimated exposure. Exposure is expres sed 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-d ay 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 aMetconazole Dietary-Exposure and Risk Assessment DP #: D387504
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### 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 reporte d eating the relevant commodities as well as those who did not) basi s. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for Tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and
noted in the risk assessment.

V. Toxicological Information

Toxicity data for metconazole have been prev iously reviewed. The CARC for metconazole met on November 2, 2005 (memo, Gregory Aker man, Ph.D., TXR# 0054211, 4/14/06). The Metconazole Endpoint Selection meeting wa s held on December 21, 2005. The Toxicity Advisory Clinic (TAC) met on 1/10/06 to discus s the acute hazard endpoint selection and the FQPA selection.

The doses and toxicological endpoi nts selected for dietary risk assessment are summarized in
Table 2.

Table 2. Summary of Toxicologica l Doses and Endpoints for Metconazole for Use in Dietary Exposure Assessment

Exposure
Scenario Dose Used in Risk Assessment, UF Hazard and Exposure Based Special FQPA Safety Factor Study and Toxicological
Effects

Acute Dietary ( General U.S. population ) An appropriate dose/endpoint attributable to a single dose was not observed in the available oral toxicity studies reviewed.

Acute Dietary ( Females 13-49 ) NOAEL = 12 mg/kg/day
UF = 100
Acute RfD = 0.12 mg/kg/day FQPA SF = 1X
aPAD = 0.12 mg/kg/day Prenatal developmental study
in rodents: LOAEL = 30 mg/kg/day based on increased
incidence of skeletal variations (predominantly lumbar ribs).

Chronic Dietary (All populations) NOAEL= 4.3 mg/kg/day

UF = 100
Chronic RfD = 0.04 mg/kg/day FQPA SF = 1X
cPAD = 0.04 mg/kg/day Chronic oral toxicity study in

rats : LOAEL = 13.1 mg/kg/day based on increased liver (M) weights and associated hepatocellular lipid vacuolation (M) and centrilobular hypertrophy(M). Same effects seen in F at 54 mg/kg/d, plus increased spleen wt.

Cancer Classification: “Not Likely to be Carcinogenic to Humans” based on convincing evidence that carcinogenic effects are not li kely below a defined dose range. A nongenotoxic mode of action for mouse liver tumo rs was established. No quantification is required.Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
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Page 7 of 17 Point of Departure (POD) = A data point or an estimated point th at is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associ ated with lower environmentally relevant human exposures.
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short-term study for long-term
risk assessment. UF DB = to account for the absence of key date (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chroni c). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.



### VI. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. population and various population subgroups. The acute results reported in Table 3 are for females 13- 49 years old. The acute and chronic results reported in Table 4 are for the general U.S. population, all infants (<1 year old), child ren 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 acute dietary (food and drinking water) exposure assessment was performed for female 13- 49 years old only since an acute endpoint was not identified for the General U.S. population. Based on the assumptions described above, acute dietary exposure of females 13-49 years old is
well below HED’s level of concer n. Combined dietary exposure from food and drinking water at
the 95 th 

### percentile of exposure is estimated to be 0.004578 mg/kg/day for females13-49 years old, equivalent to 3.8% of the acute Population Adjusted Dose (aPAD); therefore, is not of concern to HED (i.e., <100% aPAD)

Table 3. Results of Acute Dietary Exposure An alysis for Food and Drinking Water Using
DEEM FCID

Population Subgroup aPAD (mg/kg/day) 95 th Percentile 99 th Percentile 99.9 th Percentile

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

Females 13-49 years old 0.12 0.004578 3.8 0.007490 6.24 9.014659 12.22



### Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The chronic dietary risk assessment shows that for all included commodities, the chronic dietary
risk estimates are not of con cern to HED [i.e., <100% chronic population-adjusted dose (cPAD)]. For the general U.S. population the exposure for f ood and water utilized 6% of the cPAD. The chronic dietary risk estimate for the highest reported exposed populat ion subgroup, children 1-2 years old, is 12.6% of the cPAD.Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
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Page 8 of 17 Table 4. Summary of Dietary (Food and Dri nking Water) Exposure Risk for Metconazolet 1

.

Population Subgroup Acute Dietary (95 th Percentile) Chronic Dietary

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

General U.S. Population 0.002434 6

All Infants (<1 year old) 0.004831 12.1

Children 1-2 years old 0.005026 12.6

Children 3-5 years old 0..004800 12

Children 6-12 years old 0.003289 8.2

Youth 13-19 years old 0.001961 4.9

Adults 20-49 years old 0.002158 5.4

Adults 50+ years old 0.001868 4.7

Females 13-49 years old 0.004578 3.8 0.001874 4.7

1 The values for the highest exposed population fo r each type of risk assessment are bolded.



### These analyses are considered to be very cons ervative dietary exposure assessments. Residues in foods were assumed to be equivalent to the to lerance levels. Tolera nce-level residues should always exceed the residue levels found on food commodities at the time of consumption. When field trials are performed, the maximum allowa ble application rate is used and crops are
harvested at the minimum PHI. Samples are stored frozen un til analysis to ensure minimal degradation of residues. In actual practice, however, growers will not usually use the maximum application rates for economic reasons. In addition, most crops are not harvested and immediately stored frozen. Al so, 100% CT was assumed and DEEM TM 

### 7.81 default processing factors were used (where provide d). For these reasons, HED is c onfident that this analysis does not underestimate risk to the general U.S. population or any population subgroup. Further refinement to the analyses could be made th rough the use of anticipated residues, empirical processing factors, and incorpora tion of percentages of crops tr eated with metconazole. Since risk estimates are not of concern to HED, a more highly refined analysis is not needed at this
time.

VII. Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with metconazole and that the residues are present at tolerance levels. In addition, drinking wa ter exposure estimates were base d on screening level estimates generated by the PRIZM-EXAMS model. Although not needed at this ti me, HED could refine the exposure and risk estimates through the use of anticipated residues an d percent crop treated data as well as refined estimated drinking wate r concentrations. However, since estimated exposures and risks using conserva tive assumptions are well belo w HED’s level of concern, such
refinement is not warranted.Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
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### VIII. Conclusions

These unrefined dietary exposur e analyses using DEEM-FCID TM 

### indicate that acute and chronic dietary exposure to metconazole from food a nd drinking water are well below HED’s level of concern for this pesticide. The estimated acu te exposure of females 13-49 years old, the only population subgroup of concern for acute exposur e, represents 3.8% of the aPAD at the 95 th


### percentile of exposure. The chr onic dietary (food + drinking wate r) exposure to metconazole is below HED’s level of concern for the gene ral U.S. population and all population subgroups. The chronic dietary exposure utilized 6% cPAD for the general U.S. population and <13% of the cPAD for children 1-2 years old, the most highly exposed population subgroup.

IX. List of Attachments

Attachment 1: Acute Food pl us Water Residue Input File Attachment 2: Acute Food plus Water Results File Attachment 3: Chronic Food pl us Water Residue Input File Attachment 4: Chronic Food plus Water Residue Results FileMetconazole Dietary-Exposure and Risk Assessment DP #: D387504
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### Attachment 1: Acute Food plus Water Residue Input File

U.S. Environmental Protection Agency Ver. 2.02 DEEM-FCID Acute analysis for METCONAZOLE Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID Files\2011\MetconazoleTuberousCormBushberry Accute.R98 Analysis Date 04-05-2011 Residue file dated: 04-05-2011/13:12:04/8 Reference dose: aRfD = 0.12 mg/kg bw/day NOEL = 12 mg/kg bw/day Comment:Vegetables,Tuberous & Corm,Subgroup 1C and Bushberry Subgroup 13-07B

---------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Food Name (ppm) #1 #2

-------- ---- -------------------------------- ------ ------ ------- 14000030 14 Almond 0.040000 1.000 1.000 14000031 14 Almond-babyfood 0.040000 1.000 1.000 14000040 14 Almond, oil 0.040000 1.000 1.000 14000041 14 Almond, oil-babyfood 0.040000 1.000 1.000 12000120 12 Apricot 0.200000 1.000 1.000 12000121 12 Apricot-babyfood 0.200000 1.000 1.000 12000130 12 Apricot, dried 0.200000 6.000 1.000 12000140 12 Apricot, juice 0.200000 1.000 1.000 12000141 12 Apricot, juice-babyfood 0.200000 1.000 1.000 01030150 1CD Arrowroot, flour 0.040000 1.000 1.000 01030151 1CD Arrowroot, flour-babyfood 0.040000 1.000 1.000 01030170 1CD Artichoke, Jerusalem 0.040000 1.000 1.000

95000230 O Banana 0.100000 1.000 1.000 95000231 O Banana-babyfood 0.100000 1.000 1.000 95000240 O Banana, dried 0.100000 3.900 1.000 95000241 O Banana, dried-babyfood 0.100000 3.900 1.000 15000250 15 Barley, pearled barley 2.830000 1.000 1.000 15000251 15 Barley, pearled barley-babyfood 2.830000 1.000 1.000 15000260 15 Barley, flour 2.830000 1.000 1.000 15000261 15 Barley, flour-babyfood 2.830000 1.000 1.000 15000270 15 Barley, bran 2.830000 1.900 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts-babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.100000 1.000 1.000 21000490 M Beef, liver 0.100000 1.000 1.000 21000491 M Beef, liver-babyfood 0.100000 1.000 1.000 01010520 1A Beet, sugar 0.070000 1.000 1.000 01010521 1A Beet, sugar-babyfood 0.070000 1.000 1.000 01010530 1A Beet, sugar, molasses 0.080000 1.000 1.000 01010531 1A Beet, sugar, molasses-babyfood 0.080000 1.000 1.000 13020570 13B Blueberry 0.400000 1.000 1.000 13020571 13B Blueberry-babyfood 0.400000 1.000 1.000 14000590 14 Brazil nut 0.040000 1.000 1.000

14000680 14 Butternut 0.040000 1.000 1.000 14000810 14 Cashew 0.040000 1.000 1.000

01030820 1CD Cassava 0.040000 1.000 1.000 01030821 1CD Cassava-babyfood 0.040000 1.000 1.000 12000900 12 Cherry 0.200000 1.000 1.000 12000901 12 Cherry-babyfood 0.200000 1.000 1.000 12000910 12 Cherry, juice 0.200000 1.500 1.000 12000911 12 Cherry, juice-babyfood 0.200000 1.500 1.000
14000920 14 Chestnut 0.040000 1.000 1.000 15001200 15 Corn, field, flour 0.030000 1.000 1.000 15001201 15 Corn, field, flour-babyfood 0.030000 1.000 1.000 15001210 15 Corn, field, meal 0.030000 1.000 1.000 15001211 15 Corn, field, meal-babyfood 0.030000 1.000 1.000 15001220 15 Corn, field, bran 0.030000 1.000 1.000 15001230 15 Corn, field, starch 0.030000 1.000 1.000 15001231 15 Corn, field, starch-babyfood 0.030000 1.000 1.000 15001240 15 Corn, field, syrup 0.030000 1.500 1.000 15001241 15 Corn, field, syrup-babyfood 0.030000 1.500 1.000 15001250 15 Corn, field, oil 0.030000 1.000 1.000 15001251 15 Corn, field, oil-babyfood 0.030000 1.000 1.000 15001260 15 Corn, pop 0.030000 1.000 1.000 15001270 15 Corn, sweet 0.020000 1.000 1.000 15001271 15 Corn, sweet-babyfood 0.020000 1.000 1.000 95001280 O Cottonseed, oil 0.250000 1.000 1.000Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
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Page 11 of 17 95001281 O Cottonseed, oil-babyfood 0.250000 1.000 1.000 95001300 O Cranberry 0.400000 1.000 1.000 95001301 O Cranberry-babyfood 0.400000 1.000 1.000 95001310 O Cranberry, dried 0.400000 1.000 1.000

13021360 13B Currant 0.400000 1.000 1.000 13021370 13B Currant, dried 0.400000 1.000 1.000 01031390 1CD Dasheen, corm 0.040000 1.000 1.000 13021490 13B Elderberry 0.400000 1.000 1.000 14001550 14 Filbert 0.040000 1.000 1.000 14001560 14 Filbert, oil 0.040000 1.000 1.000 01031660 1CD Ginger 0.040000 1.000 1.000 01031661 1CD Ginger-babyfood 0.040000 1.000 1.000 01031670 1CD Ginger, dried 0.040000 1.000 1.000 23001700 M Goat, meat byproducts 0.100000 1.000 1.000 23001720 M Goat, kidney 0.100000 1.000 1.000 23001730 M Goat, liver 0.100000 1.000 1.000 13021740 13B Gooseberry 0.400000 1.000 1.000 14001850 14 Hickory nut 0.040000 1.000 1.000 13021910 13B Huckleberry 0.400000 1.000 1.000 14002130 14 Macadamia nut 0.040000 1.000 1.000 12002300 12 Nectarine 0.200000 1.000 1.000 15002310 15 Oat, bran 1.340000 1.900 1.000 15002320 15 Oat, flour 1.340000 1.000 1.000 15002321 15 Oat, flour-babyfood 1.340000 1.000 1.000 15002330 15 Oat, groats/rolled oats 1.340000 1.000 1.000 15002331 15 Oat, groats/rolled oats-babyfood 1.340000 1.000 1.000

12002600 12 Peach 0.200000 1.000 1.000 12002601 12 Peach-babyfood 0.200000 1.000 1.000 12002610 12 Peach, dried 0.200000 7.000 1.000 12002611 12 Peach, dried-babyfood 0.200000 7.000 1.000 12002620 12 Peach, juice 0.200000 1.000 1.000 12002621 12 Peach, juice-babyfood 0.200000 1.000 1.000

95002630 O Peanut 0.040000 1.000 1.000 95002640 O Peanut, butter 0.050000 1.890 1.000 95002650 O Peanut, oil 0.050000 1.300 1.000

14002690 14 Pecan 0.040000 1.000 1.000 14002820 14 Pistachio 0.040000 1.000 1.000 95002830 O Plantain 0.100000 1.000 1.000 95002840 O Plantain, dried 0.100000 3.900 1.000
12002850 12 Plum 0.200000 1.000 1.000 12002851 12 Plum-babyfood 0.200000 1.000 1.000 12002860 12 Plum, prune, fresh 0.200000 1.000 1.000 12002861 12 Plum, prune, fresh-babyfood 0.200000 1.000 1.000 12002870 12 Plum, prune, dried 0.200000 2.300 1.000 12002871 12 Plum, prune, dried-babyfood 0.200000 2.300 1.000 12002880 12 Plum, prune, juice 0.200000 1.400 1.000 12002881 12 Plum, prune, juice-babyfood 0.200000 1.400 1.000 01032960 1C Potato, chips 0.040000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.040000 1.000 1.000 01032971 1C Potato, dry (granules/ flakes)-b 0.040000 1.000 1.000 01032980 1C Potato, flour 0.040000 1.000 1.000 01032981 1C Potato, flour-babyfood 0.040000 1.000 1.000 01032990 1C Potato, tuber, w/peel 0.040000 1.000 1.000 01032991 1C Potato, tuber, w/peel-babyfood 0.040000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.040000 1.000 1.000 01033001 1C Potato, tuber, w/o peel-babyfood 0.040000 1.000 1.000 20003190 20 Rapeseed, oil 0.040000 1.000 1.000 20003191 20 Rapeseed, oil-babyfood 0.040000 1.000 1.000 15003280 15 Rye, grain 0.290000 1.000 1.000 15003290 15 Rye, flour 0.290000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003420 M Sheep, kidney 0.100000 1.000 1.000 26003430 M Sheep, liver 0.100000 1.000 1.000 06003470 6 Soybean, seed 0.050000 1.000 1.000 06003480 6 Soybean, flour 0.050000 1.000 1.000 06003481 6 Soybean, flour-babyfood 0.050000 1.000 1.000 06003490 6 Soybean, soy milk 0.050000 1.000 1.000 06003491 6 Soybean, soy milk-babyfood or in 0.050000 1.000 1.000 06003500 6 Soybean, oil 0.050000 1.000 1.000 06003501 6 Soybean, oil-babyfood 0.050000 1.000 1.000 95003620 O Sugarcane, sugar 1.600000 1.000 1.000 95003621 O Sugarcane, sugar-babyfood 1.600000 1.000 1.000Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

_____________________________________________________________________________________________

Page 12 of 17 95003630 O Sugarcane, molasses 3.200000 2.000 1.000 95003631 O Sugarcane, molasses-babyfood 3.200000 2.000 1.000 01033660 1CD Sweet potato 0.040000 1.000 1.000 01033661 1CD Sweet potato-babyfood 0.040000 1.000 1.000 01033710 1CD Tanier, corm 0.040000 1.000 1.000 01033870 1CD Turmeric 0.040000 1.000 1.000
14003910 14 Walnut 0.040000 1.000 1.000 86010000 O Water, direct, all sources 0.045480 1.000 1.000 86020000 O Water, indirect, all sources 0.045480 1.000 1.000 15004010 15 Wheat, grain 0.180000 1.000 1.000 15004011 15 Wheat, grain-babyfood 0.180000 1.000 1.000 15004020 15 Wheat, flour 0.180000 1.000 1.000 15004021 15 Wheat, flour-babyfood 0.180000 1.000 1.000 15004030 15 Wheat, germ 0.180000 1.000 1.000 15004040 15 Wheat, bran 0.180000 1.900 1.000 01034060 1CD Yam, true 0.040000 1.000 1.000 01034070 1CD Yam bean 0.040000 1.000 1.000



### Attachment 2: Acute Food plus Water Results File

U.S. Environmental Protection Agency Ver. 2.02 DEEM-FCID ACUTE Analysis for METCONAZOLE (1994-98 data) Residue file: MetconazoleTuberousCormBushberry Accute.R98 Adjustment factor #2 NOT used. Analysis Date: 04-05-2011/13:13:30 Residue file dated: 04-05-2011/13:12:04/8 NOEL (Acute) = 12.000000 mg/kg body-wt/day Daily totals for food and foodform consumption used. Run Comment: "Vegetables, Tuberous & Corm, Subgroup 1C and Bushberry Subgroup

13-07B "

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

Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Females 13-49 yrs:

0.004578 3.81 2621 0.007573 6.31 1584 0.014748 12.29 813Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

_____________________________________________________________________________________________

Page 13 of 17 

### Attachment 3: Chronic Food pl us Water Residue Input File

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for METCONAZOLE 1994-98 data Residue file: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID Files\2011\MetconazoleTuberousCormBushberry Chronic.R98 Adjust. #2 NOT used Analysis Date 04-05-2011 Residue file dated: 04-05-2011/13:20:02/8 Reference dose (RfD) = 0.04 (NOEL) = 4.3 mg/kg bw/day Comment:Vegetables, Tuberous & Corm, Subgroup 1C and Bushberry Subgroup 13-07B

-------------------------------------------------------------------------------- Food Crop Residue Adj.Factors Comment EPA Code Grp Food Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 14000030 14 Almond 0.040000 1.000 1.000 14000031 14 Almond-babyfood 0.040000 1.000 1.000 14000040 14 Almond, oil 0.040000 1.000 1.000 14000041 14 Almond, oil-babyfood 0.040000 1.000 1.000 12000120 12 Apricot 0.200000 1.000 1.000 12000121 12 Apricot-babyfood 0.200000 1.000 1.000 12000130 12 Apricot, dried 0.200000 6.000 1.000 12000140 12 Apricot, juice 0.200000 1.000 1.000 12000141 12 Apricot, juice-babyfood 0.200000 1.000 1.000 01030150 1CD Arrowroot, flour 0.040000 1.000 1.000 01030151 1CD Arrowroot, flour-babyfood 0.040000 1.000 1.000 01030170 1CD Artichoke, Jerusalem 0.040000 1.000 1.000

95000230 O Banana 0.100000 1.000 1.000Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

_____________________________________________________________________________________________

Page 14 of 17 95000231 O Banana-babyfood 0.100000 1.000 1.000 95000240 O Banana, dried 0.100000 3.900 1.000 95000241 O Banana, dried-babyfood 0.100000 3.900 1.000 15000250 15 Barley, pearled barley 2.830000 1.000 1.000 15000251 15 Barley, pearled barley-babyfood 2.830000 1.000 1.000 15000260 15 Barley, flour 2.830000 1.000 1.000 15000261 15 Barley, flour-babyfood 2.830000 1.000 1.000 15000270 15 Barley, bran 2.830000 1.900 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts-babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.100000 1.000 1.000 21000490 M Beef, liver 0.100000 1.000 1.000 21000491 M Beef, liver-babyfood 0.100000 1.000 1.000 01010520 1A Beet, sugar 0.070000 1.000 1.000 01010521 1A Beet, sugar-babyfood 0.070000 1.000 1.000 01010530 1A Beet, sugar, molasses 0.080000 1.000 1.000 01010531 1A Beet, sugar, molasses-babyfood 0.080000 1.000 1.000 13020570 13B Blueberry 0.400000 1.000 1.000 13020571 13B Blueberry-babyfood 0.400000 1.000 1.000 14000590 14 Brazil nut 0.040000 1.000 1.000

14000680 14 Butternut 0.040000 1.000 1.000 14000810 14 Cashew 0.040000 1.000 1.000

01030820 1CD Cassava 0.040000 1.000 1.000 01030821 1CD Cassava-babyfood 0.040000 1.000 1.000 12000900 12 Cherry 0.200000 1.000 1.000 12000901 12 Cherry-babyfood 0.200000 1.000 1.000 12000910 12 Cherry, juice 0.200000 1.500 1.000 12000911 12 Cherry, juice-babyfood 0.200000 1.500 1.000
14000920 14 Chestnut 0.040000 1.000 1.000 15001200 15 Corn, field, flour 0.030000 1.000 1.000 15001201 15 Corn, field, flour-babyfood 0.030000 1.000 1.000 15001210 15 Corn, field, meal 0.030000 1.000 1.000 15001211 15 Corn, field, meal-babyfood 0.030000 1.000 1.000 15001220 15 Corn, field, bran 0.030000 1.000 1.000 15001230 15 Corn, field, starch 0.030000 1.000 1.000 15001231 15 Corn, field, starch-babyfood 0.030000 1.000 1.000 15001240 15 Corn, field, syrup 0.030000 1.500 1.000 15001241 15 Corn, field, syrup-babyfood 0.030000 1.500 1.000 15001250 15 Corn, field, oil 0.030000 1.000 1.000 15001251 15 Corn, field, oil-babyfood 0.030000 1.000 1.000 15001260 15 Corn, pop 0.030000 1.000 1.000 15001270 15 Corn, sweet 0.020000 1.000 1.000 15001271 15 Corn, sweet-babyfood 0.020000 1.000 1.000 95001280 O Cottonseed, oil 0.250000 1.000 1.000 95001281 O Cottonseed, oil-babyfood 0.250000 1.000 1.000 95001300 O Cranberry 0.400000 1.000 1.000 95001301 O Cranberry-babyfood 0.400000 1.000 1.000 95001310 O Cranberry, dried 0.400000 1.000 1.000

13021360 13B Currant 0.400000 1.000 1.000 13021370 13B Currant, dried 0.400000 1.000 1.000 01031390 1CD Dasheen, corm 0.040000 1.000 1.000 13021490 13B Elderberry 0.400000 1.000 1.000 14001550 14 Filbert 0.040000 1.000 1.000 14001560 14 Filbert, oil 0.040000 1.000 1.000 01031660 1CD Ginger 0.040000 1.000 1.000 01031661 1CD Ginger-babyfood 0.040000 1.000 1.000 01031670 1CD Ginger, dried 0.040000 1.000 1.000 23001700 M Goat, meat byproducts 0.100000 1.000 1.000 23001720 M Goat, kidney 0.100000 1.000 1.000 23001730 M Goat, liver 0.100000 1.000 1.000 13021740 13B Gooseberry 0.400000 1.000 1.000 14001850 14 Hickory nut 0.040000 1.000 1.000 13021910 13B Huckleberry 0.400000 1.000 1.000 14002130 14 Macadamia nut 0.040000 1.000 1.000 12002300 12 Nectarine 0.200000 1.000 1.000 15002310 15 Oat, bran 1.340000 1.900 1.000 15002320 15 Oat, flour 1.340000 1.000 1.000 15002321 15 Oat, flour-babyfood 1.340000 1.000 1.000 15002330 15 Oat, groats/rolled oats 1.340000 1.000 1.000 15002331 15 Oat, groats/rolled oats-babyfood 1.340000 1.000 1.000

12002600 12 Peach 0.200000 1.000 1.000 12002601 12 Peach-babyfood 0.200000 1.000 1.000Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

_____________________________________________________________________________________________

Page 15 of 17 12002610 12 Peach, dried 0.200000 7.000 1.000 12002611 12 Peach, dried-babyfood 0.200000 7.000 1.000 12002620 12 Peach, juice 0.200000 1.000 1.000 12002621 12 Peach, juice-babyfood 0.200000 1.000 1.000

95002630 O Peanut 0.040000 1.000 1.000 95002640 O Peanut, butter 0.050000 1.890 1.000 95002650 O Peanut, oil 0.050000 1.300 1.000

14002690 14 Pecan 0.040000 1.000 1.000 14002820 14 Pistachio 0.040000 1.000 1.000 95002830 O Plantain 0.100000 1.000 1.000 95002840 O Plantain, dried 0.100000 3.900 1.000
12002850 12 Plum 0.200000 1.000 1.000 12002851 12 Plum-babyfood 0.200000 1.000 1.000 12002860 12 Plum, prune, fresh 0.200000 1.000 1.000 12002861 12 Plum, prune, fresh-babyfood 0.200000 1.000 1.000 12002870 12 Plum, prune, dried 0.200000 2.300 1.000 12002871 12 Plum, prune, dried-babyfood 0.200000 2.300 1.000 12002880 12 Plum, prune, juice 0.200000 1.400 1.000 12002881 12 Plum, prune, juice-babyfood 0.200000 1.400 1.000 01032960 1C Potato, chips 0.040000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.040000 1.000 1.000 01032971 1C Potato, dry (granules/ flakes)-b 0.040000 1.000 1.000 01032980 1C Potato, flour 0.040000 1.000 1.000 01032981 1C Potato, flour-babyfood 0.040000 1.000 1.000 01032990 1C Potato, tuber, w/peel 0.040000 1.000 1.000 01032991 1C Potato, tuber, w/peel-babyfood 0.040000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.040000 1.000 1.000 01033001 1C Potato, tuber, w/o peel-babyfood 0.040000 1.000 1.000 20003190 20 Rapeseed, oil 0.040000 1.000 1.000 20003191 20 Rapeseed, oil-babyfood 0.040000 1.000 1.000 15003280 15 Rye, grain 0.290000 1.000 1.000 15003290 15 Rye, flour 0.290000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003420 M Sheep, kidney 0.100000 1.000 1.000 26003430 M Sheep, liver 0.100000 1.000 1.000 06003470 6 Soybean, seed 0.050000 1.000 1.000 06003480 6 Soybean, flour 0.050000 1.000 1.000 06003481 6 Soybean, flour-babyfood 0.050000 1.000 1.000 06003490 6 Soybean, soy milk 0.050000 1.000 1.000 06003491 6 Soybean, soy milk-babyfood or in 0.050000 1.000 1.000 06003500 6 Soybean, oil 0.050000 1.000 1.000 06003501 6 Soybean, oil-babyfood 0.050000 1.000 1.000 95003620 O Sugarcane, sugar 1.600000 1.000 1.000 95003621 O Sugarcane, sugar-babyfood 1.600000 1.000 1.000 95003630 O Sugarcane, molasses 3.200000 2.000 1.000 95003631 O Sugarcane, molasses-babyfood 3.200000 2.000 1.000 01033660 1CD Sweet potato 0.040000 1.000 1.000 01033661 1CD Sweet potato-babyfood 0.040000 1.000 1.000 01033710 1CD Tanier, corm 0.040000 1.000 1.000 01033870 1CD Turmeric 0.040000 1.000 1.000
14003910 14 Walnut 0.040000 1.000 1.000 86010000 O Water, direct, all sources 0.038160 1.000 1.000 86020000 O Water, indirect, all sources 0.038160 1.000 1.000 15004010 15 Wheat, grain 0.180000 1.000 1.000 15004011 15 Wheat, grain-babyfood 0.180000 1.000 1.000 15004020 15 Wheat, flour 0.180000 1.000 1.000 15004021 15 Wheat, flour-babyfood 0.180000 1.000 1.000 15004030 15 Wheat, germ 0.180000 1.000 1.000 15004040 15 Wheat, bran 0.180000 1.900 1.000 01034060 1CD Yam, true 0.040000 1.000 1.000 01034070 1CD Yam bean 0.040000 1.000 1.000Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

_____________________________________________________________________________________________

Page 16 of 17 

### Attachment 4: Chronic Food plus Water Residue Results File

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for METCONAZOLE (1994-98 data) Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID Files\2011\MetconazoleTuberousCormBushberry Chronic.R98 Adjustment factor #2 NOT used. Analysis Date 04-05-2011/15:42:35 Residue file dated: 04-05-2011/13:20:02/8 Reference dose (RfD, Chronic) = .04 mg/kg bw/day NOEL (Chronic) = 4.3 mg/kg bw/day COMMENT 1: Vegetables, Tuberous & Corm, Subgroup 1C and Bushberry Subgroup 13-07B

=============================================================================== 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) 0.002434 1,766 6.1%

U.S. Population (spring season) 0.002505 1,716 6.3% U.S. Population (summer season) 0.002499 1,721 6.2% U.S. Population (autumn season) 0.002363 1,820 5.9% U.S. Population (winter season) 0.002372 1,813 5.9%

Northeast region 0.002325 1,850 5.8% Midwest region 0.002584 1,664 6.5% Southern region 0.002294 1,874 5.7% Western region 0.002595 1,657 6.5%

Hispanics 0.002447 1,758 6.1% Non-hispanic whites 0.002462 1,747 6.2% Non-hispanic blacks 0.002295 1,874 5.7% Non-hisp/non-white/non-black 0.002359 1,823 5.9%

All infants (< 1 year) 0.004831 890 12.1% Nursing infants 0.002219 1,938 5.5% Non-nursing infants 0.005823 738 14.6% Children 1-6 yrs 0.004787 898 12.0% Children 7-12 yrs 0.003113 1,381 7.8%

Females 13-19 (not preg or nursing) 0.001774 2,424 4.4% Females 20+ (not preg or nursing) 0.001840 2,337 4.6% Females 13-50 yrs 0.001985 2,167 5.0% Females 13+ (preg/not nursing) 0.002024 2,124 5.1% Females 13+ (nursing) 0.002381 1,806 6.0%

Males 13-19 yrs 0.002137 2,012 5.3% Males 20+ yrs 0.002275 1,890 5.7% Seniors 55+ 0.001840 2,337 4.6%

Children 1-2 yrs 0.005026 856 12.6%Metconazole Dietary-Exposure and Risk Assessment DP #: D387504
PC Code: 125619

_____________________________________________________________________________________________

Page 17 of 17 Children 3-5 yrs 0.004800 896 12.0% Children 6-12 yrs 0.003289 1,307 8.2% Youth 13-19 yrs 0.001961 2,193 4.9% Adults 20-49 yrs 0.002158 1,992 5.4% Adults 50+ yrs 0.001868 2,302 4.7% Females 13-49 yrs 0.001874 2,295 4.7%