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COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

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TEMPLATE:

[Insert petition number]

 [metconazole,
5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)
cyclopentanol, measured as the sum of cis- and trans- isomers] in or on
the raw agricultural commodities [fruits, stone (Crop Group 12) at 0.2
parts per million (ppm); nuts, tree (Crop Group 14) including pistachio
at 0.02 ppm; almond hulls at 5.0 ppm; and peanut at 0.02 ppm]. 

[Insert petition number]

 [metconazole,
5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)
cyclopentanol, measured as the sum of cis- and trans-isomers] in or on
the raw agricultural commodities [barley, grain at 2.0 parts per million
ppm; barley, hay at 7.0 ppm, barley straw at 7.0 ppm; beet, sugar, root
at 0.1 ppm; beet, sugar, tops at 2.0 ppm; beet, sugar, pulp, dry at 1.9
ppm; beet, sugar, molasses at 0.2 ppm; beet, sugar, raw at 0.25 ppm; 
oat, grain at 1.0 ppm; oat, straw at 6.0 ppm; oat, hay at 17 ppm; rye,
grain at 0.25 ppm; rye, straw at 14.0 ppm; soybean, forage at 3.0 ppm;
soybean, hay at 6.0 ppm; soybean, seed at 0.10 ppm; soybean, aspirated
grain fractions at 1.0 ppm; soybean, hulls at 0.2 ppm; triticale at 0.25
ppm, wheat, grain at 0.15 ppm; wheat, hay at 16.0 ppm; wheat, straw at
18.0 ppm;  wheat, aspirated grain fractions at 10.0 ppm; wheat, milled
byproducts at 1.0 ppm].

EPA has determined that the petitions contain data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the
petitions.  Additional data may be needed before EPA rules on the
petitions.

                                      

. [Nature of the residue studies (OPPTS Harmonized Guideline 860.1300)
were conducted in wheat, canola, banana, peas, and mandarin oranges as
representative crops in order to characterize the fate of metconazole in
all crop matrices. Two radiocarbon labeling positions were studied in
each crop. In all crops triazole ring labeling was used, and the other
label was positioned either in the p-chlorophenyl or the cyclopentyl
rings. In all five crops the metconazole Residues of Concern (ROC) were
characterized as parent metconazole. A confined rotational crop study
also determined that parent metconazole was the residue of concern in
the representative crops of wheat, radish, and lettuce/spinach. 

. [Independently validated analytical method have been submitted for
analyzing parent metconazole residues with appropriate sensitivity in
all the crop and processed commodities for soybean, sugar beet, barley,
wheat, oats, rye, stone fruit [crop group 12], tree nuts [crop group
14], and peanuts) for which tolerances are being requested.  

. [Field trials were carried out to determine the magnitude of the
residue in/on soybean, sugar beet, barley, wheat, oats, rye, stone fruit
[crop group 12], tree nuts [crop group 14], and peanuts. The number and
locations of field trials are in accordance with OPPTS Guideline
860.1500. Field trials were carried out using the maximum label rates,
the maximum number of applications, and the minimum pre-harvest interval
(PHI) for all the crops. Detected residues of metconazole in all crops
support the proposed tolerances.

[A complete, valid and reliable database of mammalian and genetic
toxicology studies supports the proposed tolerance for metconazole on
stone fruit, tree nuts, and peanut (Valent uses) and wheat, barley, rye,
oat, sugar beet, and soybean (BASF uses). Two geometric isomers of
metconazole exist, with the fungicidal activity being associated
primarily with the cis isomer. The technical material is composed of >97
% (nominal) active ingredient and that is manufactured for use on stone
fruit, tree nuts, and peanut (Valent uses) and wheat, barley, rye, oat,
sugar beet, and soybean (BASF uses) is a mixture of cis- and trans-
isomers in an 85 to 15 ratio (85:15).  Toxicology studies submitted in
support of this petition were conducted on the metconazole technical
material composed of either the 85:15 isomer mixture (AC 900768) or a
more purified (greater than 95%) sample of the cis-isomer (WL 136184). 

 AC 900768 technical is considered to be slightly toxic (Toxicity
Category III) to the rat by the oral route of exposure. In an acute oral
study in rats, the LD50 value of AC 900768 technical was 727 milligrams
per kilogram of body weight (mg/kg b.w.) for males and 595 mg/kg b.w.
for females. The oral LD50 for combined sexes was 660 mg/kg b.w. An oral
LD50 study in rats conducted with WL 136184 technical also supports the
classification of metconazole as slightly toxic by the oral route of
exposure. The oral LD50 values of WL 136184 technical were 1,626 mg/kg
b.w. for males and 1,312 mg/kg b.w. for females, with an LD50 value for
combined sexes of 1,459 mg/kg b.w.

The 85:15 isomer mixture demonstrates no acute toxicity via the dermal
route of exposure [LD50 value >2000 mg/kg (highest dose tested)]
(Toxicity Category III) or inhalation route of exposure [LC50 >5.6 mg/L]
(Toxicity Category IV).  The material is mildly irritating to the eye
(Toxicity Category III) and is not irritating to the skin (Toxicity
Category IV), nor is it a skin sensitizer.]   

Genotoxicity.  [AC 900768 technical (the 85:15 isomer mixture) and WL
136184 technical (greater than 95% cis isomer) were tested in an
extensive battery of in vitro and in vivo genotoxicity assays measuring
several different endpoints of potential genotoxicity. Collective
results from these studies indicate that metconazole does not pose a
genotoxic risk, and therefore, is not likely to be a genotoxic
carcinogen.] 

. [Developmental toxicity studies in rats conducted with AC 900768
technical and WL 136184 technical showed no evidence of teratogenic
effects in fetuses, and no evidence of developmental toxicity in the
absence of maternal toxicity. Thus, metconazole is neither a selective
developmental toxicant nor a teratogen in the rat. Two rat developmental
toxicity studies have been conducted with AC 900768 technical. In the
first study, the no-observable-adverse-effect-level (NOAEL) for maternal
toxicity was 12 mg/kg b.w./ day, based on decreased body weight gain at
30 mg/kg b.w./day, the next highest dose tested, and the NOAEL for
developmental toxicity was also 12 mg/kg b.w./day, based on decreased
fetal body weights and an increased incidence of skeletal ossification
variations at 30 mg/kg b.w./day. In the second study, the maternal and
fetal NOAEL was 16 mg/kg/day based on findings similar to the first
study at the next higher dose level of 65 mg/kg/day. In the rat
developmental toxicity study conducted with WL 136184 technical, the
NOAEL for maternal toxicity was 24 mg/kg b.w./day based on decreased
body weight gain at 60 mg/kg b.w./day, the highest dose tested, and the
NOAEL for developmental toxicity was also 24 mg/kg b.w./day, based on an
increase in the total number of resorptions, reductions in fetal body
weights and an increased incidence of skeletal ossification variations
at 60 mg/kg b.w./day. 

Results from a developmental toxicity study in rabbits with the 85:15
isomer mixture also indicated no evidence of teratogenicity or
developmental toxicity in the absence of maternal toxicity. Thus,
metconazole technical is neither a selective developmental toxicant nor
a teratogen in the rabbit. In this rabbit developmental study, the NOAEL
for maternal toxicity was 20 mg/kg b.w./day based on decreased food
consumption and body weight gain, reductions in hemoglobin, hematocrit
and corpuscular volume, increases in platelet counts and alkaline
phosphatase activity, and increased absolute and relative liver weights
at 40 mg/kg b.w./day (the highest dose tested). The NOAEL for
developmental toxicity was also 20 mg/ kg b.w./day, based on an increase
in the total number and mean number of resorptions and decreased fetal
body weight at 40 mg/kg b.w./day. 

Two multi-generation reproduction studies were conducted with
Metconazole Technical -- one with the >95% cis form and one with the
85/15 cis/trans form.  Dose levels and results in both studies were
similar, although the 95% cis study diet was adjusted to maintain a
constant dose.  Dose levels in the >95% cis study were 0, 2, 8, 32 and
48 mg/kg/day and in the 85/15 cis study were 0, 30, 150 and 750 ppm
(approximately 0, 2.1, 10.6 and 52.8 mg/kg/day for pre-mating growth
period).  For the >95% cis study, the results support a NOAEL for
parental toxicity of 8 mg/kg/day based on increased ovarian weight and
increased gestation length at the next highest dose tested (32
mg/kg/day).   The NOAEL for growth and development of the offspring is
also 8 mg/kg/day, based on reductions in live litter size for F2 litters
at 32 mg/kg/day.  The NOAEL for reproductive performance and fertility
was 48 mg/kg/day (the highest dose tested).  In the 85/15 cis/trans
study, the NOAEL identified for parental toxicity, offspring growth and
development and reproductive toxicity was 10.8 mg/kg/day (150 ppm) based
on effects observed at the highest dose tested of 52.8 mg/kg/day (750
ppm).

Results of the pilot and definitive reproduction studies and
developmental toxicity studies conducted with AC 900768 technical and/or
WL 136184 technical show no increased sensitivity to developing
offspring as compared to parental animals, as comparable NOAELs were
obtained for parental toxicity and growth and development of offspring.]


Subchronic toxicity.  [Short-term (28-day) dietary toxicity studies in
rats were conducted with AC 900768 and WL 136184 technical materials. In
the 28-day study with AC 900768, the NOAEL was 100 ppm (approximately
9.6 mg/kg b.w./day), based on reductions in body weight, body weight
gain, food consumption, and hemoglobin concentration for males, as well
as increased absolute and relative liver weights, and increased
incidences of hepatic fatty vacuolation and parenchymal hypertrophy for
males and females at 1,000 ppm (the next highest concentration tested).
Similar results were observed in the study conducted with WL 136184
technical. Based on these results, the NOAEL for WL 136184 is 300 ppm
(approximately 28.5 mg/kg b.w./day), supported by decreased body weights
and body weight gains and increased incidences of hepatic fatty
vacuolation for males and females, increased absolute and adjusted liver
weights for females, and decreased food consumption for males at 1,000
ppm (the next highest concentration tested). 

In a 28-day dietary study in dogs conducted with AC 900768 technical
(85:15 isomer mixture), the NOAEL was a dietary concentration of 1,000
ppm (approximately 38.6 mg/kg b.w./day), based on decreased food
consumption, body weight losses, increased alkaline phosphatase
activity, increased spleen and liver weights, and urinalysis changes for
males and females, and increased absolute and relative thyroid gland
weights for females at 7,000 ppm, the highest concentration tested. 

Subchronic (90-day) dietary studies in rats were conducted with AC
900768 technical and WL 136184 technical. In the study conducted with AC
900768, the NOAEL was 100 ppm (approximately 6.8 mg/kg b.w./day) based
on hepatic fatty vacuolation in males at 300 ppm, the next highest
concentration tested. The NOAEL from the study conducted with WL 136184
technical was 450 ppm (approximately 30.9 mg/kg b.w./day) based on
decreased food consumption, body weights, and body weight gains,
clinical chemistry changes, increased absolute and adjusted liver
weights, and histopathological changes in the liver and/or stomach for
males and females, and decreased red blood cell parameters for females
at 1,350 ppm, the highest concentration tested. 

In a 90-day dietary study in mice conducted with AC 900768, the NOAEL
was 30 ppm (approximately 5.5 mg/kg b.w./day), based on increased
aspartate and alanine aminotransferase activities in males, increased
absolute and relative weights of the liver and spleen of females, and
increased incidences of hepatocellular vacuolation and hypertrophy for
males and females at 300 ppm, the next highest concentration tested. 

A 90-day dietary study in beagle dogs with AC 900768 technical supports
a NOAEL of 60 ppm (approximately 2.5 mg/kg b.w./day) based on decreased
body weight gain and food consumption for females, and a slight increase
in reticulocyte count for males at 600 ppm, the next highest
concentration tested.  

  [NOTE: At the 90-day timepoint of the chronic (one-year) toxicity
study in the dog, the NOAEL for decreased body weight gain is 300 ppm
(approximately 11.1 mg/kg b.w./day).]

.  [Findings similar to those observed in the short-term subchronic
studies were also apparent in the long-term dietary toxicity studies
conducted in rats, dogs and mice. 

In a chronic toxicity study, Llong-term (104-weeks) administration of
metconazole technical to rats supported a NOAEL for systemic toxicity of
100 ppm (approximately 4.8 mg/kg b.w./day), based on increased adjusted
liver weight, clinical chemistry changes, and increased incidences of
hepatocellular lipid vacuolation and centrilobular hypertrophy at
interim sacrifice for males at 300 ppm, the next highest concentration
tested. 

In a 104-week carcinogenicity study in rats fed diets containing 0, 100,
300 or 1000 ppm metconazole technical, the NOAEL for carcinogenicity was
1000 ppm (50 mg/kg/day) the highest dose tested.  The NOAEL for chronic
systemic toxicity was 100 ppm (5.6 mg/kg/day) based on increased
incidences of centrilobular hypertrophy and pigment disposition in the
liver and increased incidences of cortical vacuolation in the adrenal at
300 ppm.

In a one-year dietary study in beagle dogs, the NOAEL was 300 ppm
(approximately 11.1 mg/ kg b.w./day), based on decreased body weight
gain for males during weeks 1 to 13 and increased alkaline phosphatase
activity for males and females at 1,000 ppm, the next highest
concentration tested. In a 104-week carcinogenicity study in rats
conducted with AC 900768, the NOAEL for carcinogenicity was 1,000 ppm
(approximately 50 mg/kg b.w./ day), the highest concentration tested. In
this study the NOAEL for chronic systemic toxicity was 100 ppm
(approximately 5.6 mg/kg b.w./day), based on increased incidences of
centrilobular hypertrophy and pigment disposition in the liver, and
increased incidences of cortical vacuolation in the adrenal in males at
300 ppm, the next highest concentration tested. 

A 91-week carcinogenicity study in mice with AC 900768 supports a NOAEL
for non-neoplastic effects of 30 ppm (approximately 4.8 mg/kg b.w./
day), based on increased white blood cell count for males, increased
aspartate and alanine aminotransferase activities and increased absolute
and adjusted liver weight for females, and microscopic changes in the
liver, spleen and adrenal gland for males and females at 300 ppm (the
next highest concentration tested). The NOAEL for carcinogenicity was
300 ppm (approximately 48.3 mg/kg b.w./day) based on increased
incidences of hepatocellular adenomas in males and females and
hepatocellular carcinomas in females at 1,000 ppm, the highest
concentration tested. The increased incidences of hepatic adenomas and
carcinomas at the highest concentration tested are considered to occur
through promotional and non-genotoxic secondary mechanisms following
toxicity and induction of mixed function oxidase in mice. Consequently,
metconazole is not likely to be oncogenic in humans at the insignificant
levels of exposure resulting from its use as a fungicide. 

. [The rat metabolism studies indicate that the qualitative nature of
the residues of metconazole in animals is adequately understood. In
studies conducted with radiolabeled AC 900768 (85:15 isomer mixture) or
radiolabeled WL 136184 (greater than 95% cis isomer) radioactivity was
rapidly eliminated in urine and feces within 48 hours of dosing. Biliary
excretion was shown to be a prominent route of elimination. At both high
and low doses of AC 900768, male rats generally excreted statistically
significantly lower amounts of radioactivity in the urine, and greater
amounts of radioactivity in the feces, compared to females. The pattern
of metabolites detected was similar at high and low doses, and little or
no parent compound was found in the feces or urine. Five days following
oral dosing of AC 900768 at the higher level, low levels of
radioactivity were detected in the majority of tissues analyzed; however
higher concentrations of radioactivity were found in the adrenal glands,
gastro-intestinal tract and liver. A comparison of radioactivity levels
in the adrenal glands following oral administration of low and high
doses indicates that uptake in the adrenal may be saturable. No
differences in tissue levels were noted between males and females.] 

. [The metabolism of metconazole technical is similar in plants and
mammals with extensive hydroxylation being the predominate reaction. 
Due to the similar structural nature of most metabolites, the toxicity
of the plant metabolites is adequately estimated from the results of
studies performed in animals.  EPA concern for several unique plant
metabolites common to most triazole fungicides is being addressed with
research conducted by the US Triazole Task Force.  On the basis of this
research, an interim human health risk assessment for aggregate exposure
to 1, 2, 4-triazole was published in the Federal Register (40 CFR Part
180, Vol. 69 No. 149 Page 47005, 8/4/04) and will be refined once the
research is complete.]

.  [The toxicology database for metconazole technical is current and
complete.  This includes a thorough evaluation of the potential effects
on reproduction and development, and the pathology of the endocrine
organs following short-term and long-term exposure.  The battery of
tests included as part of this petition fully characterizes potential
endocrine-related in vivo effects, clearly defines NOAEL/LOAEL values,
and indicates no increased sensitivity to developing offspring.]

. [Exposure assessments were conducted to evaluate the potential risk
due to acute and chronic dietary exposure of the U.S. population to
residues of metconazole. This fungicide considering both the cis and
trans isomers, in or on raw agricultural commodities, was expressed as
the parent compound.  The analysis included all the proposed tolerance
values for soybean, sugar beet, barley, wheat, oats, rye, triticale,
stone fruit (crop group 12), tree nuts (crop group 14), peanuts, and
bananas.]

[Acute Dietary Exposure Assessment

Acute dietary exposure estimates were based on proposed tolerance
values, default process factors with the exception of a determined
process factor for sugar beet molasses, and 100% of all crops treated. 
The consumption data was from the USDA Continuing Survey of Food Intake
by Individuals (CSFII 1994 - 1996, 1998) and the EPA Food Commodity
Ingredient Database (FCID) using Exponent's Dietary Exposure Evaluation
Module (DEEM-FCID) software.  

The result exposure estimates were compared against the metconazole
acute Population Adjusted Dose (aPAD) of 0.16 mg/kg b.w./day for females
13-49 years of age.  This endpoint is based on the NOAEL from a rat
developmental toxicity study of 16 mg/kg/day with an FQPA safety factor
of 1.  An acute oral toxicological endpoint could not be determined for
all other sub-populations.  Considering the exposure assumptions
discussed above, metconazole acute dietary exposure from food is 0.88 %
aPAD for females 13-49 years of age.  The results of the acute dietary
assessment are presented in Table 1.

Table 1.	Results for Metconazole Acute Dietary Exposure Analysis
Considering all Proposed Tolerances using DEEM-FCID at the 95th
Percentile 

Population	Exposure Estimate	%aPAD

Subgroups	(mg/kg b.w./day)*	 

U.S. Population	0.00251	NA

All Infants (< 1 year old)	0.004683	NA

Children (1-2 years old)	0.004738	NA

Children (3-5 years old)	0.003825	NA

Children (6-12 years old)	0.002258	NA

Youth (13-19 years old)	0.001347	NA

Females (13-49 years old)	0.00140	0.88

Adults (20-49 years old)	0.002625	NA

Adults (50+ years old)	0.001594	NA



The results of the analysis show that for females 13-49 years of age,
the estimated exposure is well below the Agency's level of concern (<
100% aPAD).  Additional refinements in the dietary risk assessment (i.e.
utilizing anticipated residue values, percent crop treated values) would
further reduce the estimated exposure values.  

Chronic Dietary Exposure Assessment

Chronic dietary exposure estimates were based on proposed tolerance
values, default process factors with the exception of a determined
process factor for sugar beet molasses, and 100% crop treated values for
all commodities.  The consumption data was from the USDA Continuing
Survey of Food Intake by Individuals (CSFII 1994 - 1996, 1998) and the
EPA Food Commodity Ingredient Database (FCID) using Exponent's Dietary
Exposure Evaluation Module (DEEM-FCID) software.  

The chronic Ppopulation Aadjusted Ddose (cPAD) used for U.S. population
and all sub-populations is 0.0483 mg/kg bw/day. This endpoint is based
on the NOAEL values from both a 104-week rat chronic toxicity study and
a mouse 78-week carcinogenicity study of 4.8 mg/kg/day with an FQPA
safety factor of 1. Considering the exposure assumptions discussed
above, metconazole chronic dietary exposure from food for the U.S.
population was 1.7 % of the cPAD.  The most highly exposure population
sub group was children 1-2 years of age at 4.1% cPAD.   The results of
the chronic dietary assessment are presented in Table 2. 

Table 2. Results for Metconazole Chronic Dietary Exposure Analysis
Considering all Proposed Tolerances using DEEM-FCID 

Population	Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)	 

U.S. Population	0.000733	1.5

All Infants (< 1 year old)	0.001231	2.6

Children (1-2 years old)	0.001754	3.7

Children (3-5 years old)	0.00147	3.1

Children (6-12 years old)	0.0009	1.9

Youth (13-19 years old)	0.000525	1.1

Females (13-49 years old)	0.000481	1.0

Adults (20-49 years old)	0.000698	1.5

Adults (50+ years old)	0.000518	1.1



The results of the analysis show that for all sub-populations, the
exposures are below a level of concern (< 100% cPAD).  Additional
refinements in the chronic dietary risk assessment (i.e. utilizing
anticipated residue values and percent crop treated values) would
further reduce the estimated exposure values.]   

. [Based on results from the PRZM/EXAMS and SCI-GROW models estimates,
the acute Estimated Drinking Wwater Concentrations (EDWC) for
metconazole exposure are estimated to be 48.22 ug/L (ppb) in surface
water and 0.42 ug/L in shallow ground water.  The chronic EDWC’s for
exposure are estimated to be 24.31 ug/L in surface water and 0.42 ug/L
in shallow ground water.  The concentrations were determinedused are
based on the maximum number of applications at the maximum label rate
and minimum interval for turf,. The turf use allows the greatest amount
of metconazole to be applied of any proposed use.  

Drinking water contributions were assessed based on the maximum
estimated metconazole water concentrations (acute - 48.22 ug/L, chronic
24.31 ug/L), and water consumption and body weights reported in CSFII,
using DEEM-FCID software.  The acute and chronic estimated water
exposure values are summarized in Tables 3 and 4, respectively.  Minimal
exposure of metconazole occurs through drinking water with 1.96% of the
aPAD for females 13-49 years of age and less than 4.0% of the cPAD for
all other subpopulations.

  

Table 3. Results for Metconazole Acute Water Exposure Analysis
Considering the Maximum Estimated Acute Drinking Water Concentration
using DEEM-FCID 

Population	Water Exposure Estimate	% aPAD

Subgroups	(mg/kg b.w./day)	 

U.S. Population	0.002519	NA

All Infants (< 1 year old)	0.009497	NA

Children (1-2 years old)	0.003952	NA

Children (3-5 years old)	0.003611	NA

Children (6-12 years old)	0.002514	NA

Youth (13-19 years old)	0.002044	NA

Females (13-49 years old)	0.002347	1.96

Adults (20-49 years old)	0.002334	NA

Adults (50+ years old)	0.002108	NA



Table 4. Results for Metconazole Chronic Water Exposure Analysis
Considering the    Maximum Estimated Chronic Drinking Water
Concentration using DEEM-FCID 

Population	Water Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)	 

U.S. Population	0.000512	1.1

All Infants (< 1 year old)	0.00168	3.5

Children (1-2 years old)	0.000761	1.6

Children (3-5 years old)	0.000712	1.5

Children (6-12 years old)	0.000491	1.0

Youth (13-19 years old)	0.00037	0.8

Females (13-49 years old)	0.000476	1.0

Adults (20-49 years old)	0.000478	1.0

Adults (50+ years old)	0.000503	1.0



Acute Aggregate Exposure and Risk (food and water)

The aggregate acute risk includes residues of metconazole from food and
water (Table 5). Exposures from residential uses are not included in the
acute aggregate assessment.  The results demonstrate that there are no
safety concerns for any subpopulation based on the proposed uses and the
results clearly meet the FQPA standard of reasonable certainty of no
harm.   

Table 5. 	Estimated Acute Aggregate Exposure and Risk of Metconazole  

Population Subgroup	aPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% aPAD

U.S. Population	NA	0.00251	0.002519	0.005029	NA

All Infants (< 1 yr old)	NA	0.004683	0.009497	0.01418	NA

Children 1-2 years	NA	0.004738	0.003952	0.00869	NA

Children 3-5 years	NA	0.003825	0.003611	0.007436	NA

Children 6 – 12 years	NA	0.002258	0.002514	0.004772	NA

Youth 13-19 years	NA	0.001347	0.002044	0.003391	NA

Females 13-49 years	0.16	0.0014	0.002347	0.003747	2.34

Adults 20-49 years	NA	0.002625	0.002334	0.004959	NA

Adults + 50	NA	0.001594	0.002108	0.003702	NA



Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of metconazole from food
and water (Table 6). Exposures from residential uses are not included in
the chronic aggregate assessment.  The results demonstrate there are no
safety concerns for any subpopulation based on the proposed uses and the
results clearly meet the FQPA standard of reasonable certainty of no
harm.

 

  Table 67. 	Estimated Chronic Aggregate Exposure and Risk of
Metconazole 

Population Subgroup	cPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% cPAD

U.S. Population	0.0483	0.000733	0.000512	0.001245	2.59

All Infants (< 1 yr old)	0.0483	0.001231	0.00168	0.002911	6.06

Children 1-2 years	0.0483	0.001754	0.000761	0.002515	5.24

Children 3-5 years	0.0483	0.00147	0.000712	0.002182	4.55

Children 6 – 12 years	0.0483	0.0009	0.000491	0.001391	2.90

Youth 13-19 years	0.0483	0.000525	0.00037	0.000895	1.86

Females 13-49 years	0.0483	0.000481	0.000476	0.000957	1.99

Adults 20-49 years	0.0483	0.000698	0.000478	0.001176	2.45

Adults + 50	0.0483	0.000518	0.000503	0.001021	2.13



	

	

There are no CODEX maximum residue levels established or proposed for
residues of metconazole in soybean, sugar beet, barley, wheat, oats,
rye, triticale, stone fruit (crop group 12), tree nuts (crop group 14),
peanuts, and bananas.]

{<HD1>}

{</HD1>}

{<HD2>}

{</HD2>}

{<P>}

{</P>}

{<HD1>}

{</HD1>}

{<HD2>}

{</HD2>}

{<P>}

{</P>}

{<HD2>}

{</HD2>}

{<P>}

{<E T=’03'>}

{</E>}

{<P>}

{<E T=’03'>}

{</E>}

{<P>}

{<E T=’03'>}

{</E>}

{<HD2>}

{</HD2>}

{<E T=’03'>}

{<E T=’03'>}

{<E T=’03'>}

{</E>}

{<E T=’03'>}

{<E T=’03'>}

{</E>}

{<E T=’03'>}

{</E>}

{<E T=’03'>}

{</E>}

{<E T=’03'>}

{</E>}

{<HD2>}

{</HD2>}

{<P>}

{<E T=’03'>}

{</E>}

{<P>}

{<E T=’03'>}

{</E>}

{</P>}

{<P>}

{<E T=’03'>}

{</E>}

{<P>}

{<E T=’03'>}

{</E>}

{</P>}

{<HD2>}

{</HD2>}

{<P>}

{<P>}

{<HD2>}

{</HD2>}

{<P>}

{<E T=’03'>}

{</E>}

{</P>}

{<P>}

{<E T=’03'>}

{</E>}

{</P>}

{<HD2>}

{</HD2>}

{<P>}

