EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: 

Hope Johnson (703) 305-5410

OAT AGRIO CO., LTD.

EPA Company No. 11581

 

5F8408

	EPA has received a pesticide petition (5F8408) from OAT AGRIO CO.,
LTD., 1-3-1 Kanda Ogawa-machi, Chiyoda-ku, Tokyo 101-0052, Japan
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

	1. by establishing a tolerance for residues of

	Flutianil,
(Z)-2-[2-fluoro-5-(trifluoromethyl)phenylthio]-2-[3-(2-methoxyphenyl)-1,
3-thiazolidin-2-ylidene]acetonitrile, including its metabolites and
degradates, in or on apple, fruit at 0.2 ppm, apple, juice at 0.03 ppm,
apple, wet pomace at 2 ppm, cantaloupe at 0.07 ppm, cherry, fruit at 0.4
ppm, cucumber at 0.02 ppm, grape, fruit at 0.7 ppm, grape, juice at 0.2
ppm, grape, raisins at 0.3 ppm, squash at 0.03 ppm, and strawberry,
fruit at 0.3 ppm. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of 
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.

A.	Residue Chemistry                                        

Plant metabolism.   

The plant metabolism of flutianil is adequately understood in four
diverse crops: apple, cucumber, grape and lettuce. The parent compound,
flutianil, accounted for the majority of residues extracted in all
crops. The metabolism of flutianil in plants is understood for the
purposes of the proposed tolerances. 

Analytical method.

The following analytical method was used for apple, cantaloupe, cherry,
cucumber, squash and strawberry samples:  residues were extracted with
acetonitrile/water solution and the aqueous sample was cleaned up by
liquid/liquid partition with hexane. The organic phase was concentrated
and further cleaned up using a silica gel column. Quantitation was
achieved by GC/MSD in selective ion monitoring mode. 

The lowest level of method validation (LLMV) in the apple study was 0.01
ppm. Based on recoveries of samples fortified at the LLMV, the limit of
detection (LOD) and limit of quantitation (LOQ) were calculated as 0.001
ppm and 0.0037 ppm, respectively for the apple RAC, 0.002 ppm and 0.0046
ppm for apple juice, and as 0.0003 ppm and 0.00076 ppm, respectively,
for apple wet pomace.

The LLMV in the cantaloupe study was 0.010 ppm. Based on recoveries of
samples fortified at the LLMV, the LOD and LOQ were calculated as 0.001
ppm and 0.0038 ppm, respectively. 

For the cherry study, the LLMV was 0.010 ppm. 

Based on recoveries of samples fortified at the LLMV, the LOD and LOQ
were calculated as 0.0009 ppm and 0.0027 ppm, respectively in the
cucumber study. The LLMV in the cucumber study was 0.01 ppm.

In the squash study, the LLMV in this study was 0.01 ppm. Based on
recoveries of samples fortified at the LLMV, LOD and LOQ were calculated
as 0.001 ppm and 0.0030 ppm, respectively.

The LOD was determined to be 0.0025 ppm for strawberry, and the LOQ was
0.0076 ppm. The LLMV was 0.010 ppm for strawberry. 

In the grape RAC and PC study, the analytical method was as follows: 
flutianil residues were analyzed and quantified in grapes, grape juice
and raisins by gas chromatography after extraction and cleanup.
Flutianil metabolite OC-56635 residues were analyzed and quantified in
grapes, grape juice and raisins by high performance liquid
chromatography with tandem mass spectral detection (LCMS/MS). A LOQ of
0.01 mg/kg was determined for flutianil and OC-56635 in grapes and grape
juice. A LOQ of 0.10 mg/kg was determined for flutianil and OC-56635 in
raisins. The limit of detection was set at 30% of the LOQ.

Magnitude of residues.

Apple

Foliar applications of flutianil (V-10118, a 5EC formulation) at a rate
of approximately 0.04 lb ai/A each were made 4 times (~7 day retreatment
interval), for a total of approximately 0.16 lb ai/A in the apple
magnitude of residues study. The results from the trials show that the
maximum residues in/on apple were 0.095 ppm. V-10118 was also applied at
5X the application rate (approximately 0.2 lb ai/A) at three sites to
provide apples for processing into juice and wet pomace. The results
from the trials show that the maximum residues in/on apple juice to be
0.016 ppm and wet pomace to be 1 ppm.	

Cantaloupe

For cantaloupes, foliar applications of V-10118 at a rate of
approximately 0.04 lb ai/A each were made 5 times (~7 day retreatment
interval), for a total of approximately 0.20 lb ai/A.  The results from
the trials show that the maximum residues in/on cantaloupe were 0.042
ppm. 

Cherry

Foliar applications of V-10118 at a rate of approximately 0.04 lb ai/A
each were made 4 times (~7 day retreatment interval), for a total of
approximately 0.16 lb ai/A for cherry.  Five applications were made at
the Washington site for a total of approximately 0.20 lb ai/A due to a
delay in crop maturity. The results from the trials show that the
maximum residues in/on cherry were 0.26 ppm.

Cucumber

For cucumbers, six trials were conducted in the field and two trials
were conducted in the greenhouse.  Foliar applications of V-10118 at a
rate of approximately 0.04 lb ai/A each were made 5 times (~7 day
retreatment interval), for a total of approximately 0.20 lb ai/A. The
maximum residues in/on cucumber were 0.014 ppm.

Grape

Foliar applications of flutianil at a rate of approximately 0.09 lb
ai/ha each were made 5 times (~7 day retreatment interval), for a total
of approximately 0.49 lb ai/ha in the grape residue study.  Flutianil
residues in treated grape samples ranged from <LOQ to 0.4977 ppm.
OC-56635 residues in treated grape samples ranged from <LOQ to 0.0536
ppm.  For grape raisins and juice, flutianil was also applied at 5X the
application rate (approximately 0.49 lb ai/ha per application) at one
site to provide grapes for processing into juice and raisins.   
Flutianil residues in grape juice were found with a maximum residue of
0.2059 ppm. Flutianil residues in raisins were found with a maximum
residue of 0.2993 ppm.   OC-56635 residues in grape juice were found
with a maximum residue of 0.0187 ppm.  OC-56635 residues in raisins were
found with a maximum residue of <LOQ.  

Squash

For squash (summer), the trials were conducted foliar applications of
V-10118 at a rate of approximately 0.04 lb ai/A each were made 5 times
(~7 day retreatment interval), for a total of approximately 0.20 lb
ai/A.  The results from the trials show that the maximum residue in/on
summer squash is 0.021 ppm.

Strawberry

For strawberries, trials foliar applications of V-10118 at a rate of
approximately 0.04 lb ai/A each were made 5 times (~7 day retreatment
interval), for a total of approximately 0.20 lb ai/A.  

At the Florida trial, one additional application was needed to allow the
fruit to ripen for a total of approximately 0.24 lb ai/A.  At the
Colorado trial, two additional applications were needed to obtain fruit
for harvest for a total of approximately 0.28 lb ai/A. The results from
the trials show that the maximum residues in/on strawberry were 0.24
ppm. 

B. Toxicological Profile

1. Acute toxicity. 

Technical flutianil shows low acute toxicity (Toxicity Category IV) via
the oral, dermal and inhalation routes of exposure. Flutianil has a very
low acute oral (LD50: >5,000 mg/kg bw), dermal (LD50: >5,000 mg/kg bw)
and inhalation toxicity (LC50: >5.17 mg/L air) in male and female rats.
Flutianil shows no irritation to the eye or skin and shows no skin
sensitization potential under the conditions of the guinea pig
maximization test. There were no acute neurotoxicity concerns. 

2. Genotoxicity. 

Flutianil was tested for its genotoxic potential in a battery of four in
vitro or in vivo studies covering all required end-points (gene
mutations, chromosomal aberrations). There was no evidence of
genotoxicity.

3. Reproductive and developmental toxicity. 

Flutianil shows no evidence of primary developmental or reproductive
effects. In the prenatal developmental toxicity studies in rats and
rabbits and in the two-generation reproduction study in rats, neither
fetal toxicity nor maternal toxicity was present. There was no evidence
to suggest that Flutianil possessed a teratogenic potential in either
species. 

4. Subchronic toxicity. 

The subchronic toxicity of Flutianil was investigated in 90-day toxicity
studies via the oral route in mouse, rat and dog and via inhalation and
dermal routes in 28-day toxicity studies in the rat. Rats, dogs, and
mice tolerated the chemical in excess of the limit dose without
mortalities or clinical signs.  The NOAEL for oral studies were 1387
mg/kg, 1271 mg/kg, and 1000 mg/kg in mouse, rat and dog respectively. 
The NOEL in the rat for dermal exposure was >1000 mg/kg and for
inhalation was 14.4 mg/kg (100 mg/m3).

 

5. Chronic toxicity. 

The chronic toxicity of Flutianil was evaluated in the dog, rat, and
mouse. Oncogenic potential was evaluated in rats and mice. The NOAEL
from the one-year feeding study in the dog was 1000 mg/kg bw/day. The
NOAEL for the rat was 249 mg/kg, the highest dose evaluated.  The NOAEL
in the oncogenic mouse study was 1063 mg/kg bw/day.  No flutianil
induced carcinogenicity was observed. Flutianil is not likely to be
carcinogenic, based on rat and mouse bioassays as well as negative in
vivo and in vitro mutagenic effects.

6. Animal metabolism.  

The elimination of flutianil was very rapid with over 90% being
eliminated in the first 24 hours with little absorbed material. 
Absorption of [14C]-flutianil was low and biotransformation of absorbed
radioactivity was rapid, giving rise to an extensive range and number of
metabolites. The number and nature of metabolites and difference in
radio-profiles for animals dosed with [trifluoromethyl-14C] and
[2-methoxyphenyl-U-14C] labelled flutianil suggested that cleavage of
the molecule was a significant process in the metabolic pathway.  This
was observed in both the rat and goat metabolism studies.

7. Metabolite toxicology.  

One major soil metabolite was evaluated in a 28-day study which showed a
NOAEL of 1380 mg/kg, which was similar to parent flutianil. 
Mutagenicity testing (in vitro bacterial reverse mutation and mouse
lymphoma gene mutation and in vivo mouse micronucleus) was conducted
with three major metabolites and all were negative. 

8. Endocrine disruption. 

The toxicology database for Flutianil is current and complete. Studies
in this database include evaluation of the potential effects on
reproduction and development and an evaluation of the pathology of the
endocrine organs following short- or long-term exposure. No endocrine
disruption is expected to be present following exposure to Flutianil.

9. Immunotoxicity. 

Flutianil was evaluated in a 28-day dietary immunotoxicity study.  The
NOEL was greater than 1251 mg/kg.  There was no effect on immune
function.

B.	Toxicological Endpoints 

A summary of the toxicological endpoints for flutianil used for human
risk assessment is shown in the following table:

Doses and Toxicological Endpoints for Flutianil

Exposure/Scenario	Dose Used in Risk Assessment, Interspecies,
Intraspecies and any Traditional UF	FQPA SF and Level of

Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (females 13-49 years of age)	Not selected	NA	No
toxicological endpoint attributable to a single exposure was identified
in the available toxicology studies.

Acute Dietary (General population including infants and children)	Not
selected	NA	No toxicological endpoint attributable to a single exposure
was identified in the available toxicology studies.

Chronic Dietary (All populations)	NOAEL = 249 mg/kg/day

UF = 100

Chronic RfD = 2.49 mg/kg/day	FQPA SF = 1x 

cPAD = Chronic RfD 	Combined Chronic Toxicity/

Carcinogenicity Study in Rat 

(MRID No. 49490550)

LOAEL = Not identified

NOAEL male: 249 mg/kg

Incidental Oral Short-Term

(1 – 30 days)	NOAEL =1000 mg/kg/day

UF = 100	LOC for MOE = 100	Developmental Toxicity in Rabbit 

(MRID No. 49490545)

LOAEL = Not identified

NOAEL = 1000 mg/kg

Incidental Oral Intermediate-Term (1 - 6 months)	NOAEL = 1271 mg/kg/day

UF = 100	LOC for MOE = 100	Subchronic Oral Toxicity in Rat 

(MRID No. 49490537)

LOAEL = Not identified

NOAEL 1271 mg/kg

Dermal (All durations)	NA	NA	No systemic toxicity was identified in the
dermal 28-day study; Highest Dose Tested was 1,000 mg/kg/day.

Inhalation (All durations)	NOAEL =14.4 mg/kg/day

UF = 100	LOC for MOE = 100

Residential

LOC for MOE = 100

Occupational	28-Day Inhalation Toxicity in Rat (MRID No. 49490541)

LOAEL = 1000 mg/m3 based on organ weight changes and histopathological
changes in liver and thyroid. (144 mg/kg conversion)

Cancer (oral, dermal, inhalation)	Classification: “Not likely to be
carcinogenic in humans.''

UF = uncertainty factor, FQPA SF = any additional safety factor retained
due to concerns unique to the FQPA, NOAEL = no observed adverse effect
level, LOAEL = lowest observed adverse effect level, PAD = population
adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE =
margin of exposure, LOC = level of concern, NA = Not Applicable

C.	Exposure Assessment

	1. 	Dietary Exposure

	a.	Acute exposure

Acute dietary risk assessments are performed for a food-use pesticide if
a toxicological study has indicated the possibility of an effect of
concern occurring as a result of a one day or single exposure. An acute
risk assessment was not performed. No toxicological endpoint
attributable to a single (acute) dietary exposure was identified.

	b.	Chronic exposure

A chronic dietary risk assessment was conducted for flutianil use on
apple, cantaloupe, cherry, cucumber, grape, squash and strawberry at the
proposed tolerances using the Dietary Exposure Evaluation Model
(DEEM-FCID™, Version 4.02) which uses food translations based on
EPA/USDA FCID recipe set as of August 2014. The chronic dietary risk
estimates are below HED’s level of concern for the general U.S.
population and all population subgroups. The most highly exposed
population subgroups (0.1% of the RfD) were children 1-2 years old and
children 3-5 years old. 

Summary of Chronic Dietary (Food + Drinking Water) Exposure and Risk for
Flutianil









Population Subgroup	

Exposure (mg/kg bw/day)	

Percent of RfD1



US population	

0.000414	0.0%



All infants ( < 1 year old)	

0.000901	0.0%



Children (1-2 years old)	0.002257	0.1%



Children (3-5 years old)	0.001446	0.1%



Children (6-12 years old)	0.000642	0.0%

Youth (13-19 years old)	0.000239	0.0%

Adults (20-49 years old)	0.000243	0.0%

Adults (50+ years old)	0.000304	0.8%



Females (13-49 years old)	0.000272	0.0%

	1 RfD = 2.49 mg/kg/day

	c.	Cancer

In accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment, flutianil may be classified as “Not likely to be
carcinogenic in humans” and is not expected to pose a cancer risk to
humans. Animal evidence demonstrates the lack of carcinogenic effects in
both sexes in well-designed and well-conducted studies in rats and mice.

	2.	Non-dietary exposure

	a.	Occupational exposure

Flutianil is formulated a 5% emulsifiable concentrate to be applied to
strawberry, cantaloupe, cucumber, summer squash, apple, cherry, and
grape using groundboom or airblast spray equipment. The potential
exposures and associated risks for handlers mixing, loading and applying
flutianil and for workers re-entering treated areas are based on the
proposed label for GATTEN® fungicide (flutianil 5% liquid formulation).
The maximum application rate is 0.04 lb ai/acre. A maximum of four to
five applications are allowed per year, depending upon crop, with a
7-day application interval. 

Short- and intermediate-term dermal and inhalation exposures are
predicted for occupational handlers mixing, loading, and applying
flutianil. Since flutianil-specific exposure data are not available,
handler scenarios were assessed using the EPA Occupational Pesticide
Handler Unit Exposure Surrogate Reference Table - Revised March 2013.
The occupational handler exposure and risk estimates for flutianil are
listed below.

Occupational Handler Exposure & Risk Estimates for Flutianil 

Short- & Intermediate-Term Exposure	Unit Exposure1 (mg/lb ai handled)
Application Rate

(lb ai/A)	Units Treated2 (A/day)	Average Daily Dose3 (mg ai/kg bw/day)
Short- & Intermediate-Term MOE4

Mixer/Loader – Liquids – Open Loading for Airblast Application

Dermal	0.0376	0.04	40	0.000158	8,000,000

Inhalation	0.000219	0.04	40	0.00000438	3,300,000

Mixer/Loader – Liquids – Open Loading for Groundboom Application

Dermal	0.0376	0.04	80	0.000316	4,000,000

Inhalation	0.000219	0.04	80	0.00000876	1,600,000

Applicator – Liquids – Airblast

Dermal	1.59	0.04	40	0.00668	190,000

Inhalation	0.00471	0.04	40	0.0000942	150,000

Applicator – Liquids – Groundboom

Dermal	0.0161	0.04	80	0.000135	9,400,000

Inhalation	0.00471	0.04	80	0.000188	76,000

1 Unit Exposure (UE) = mg ai/lb ai handled from Occupational Pesticide
Handler Unit Exposure Surrogate Reference Table - Revised March 2013. 
PPE = long-sleeve shirt, long pants, socks, shoes, gloves.

2 Units Treated taken from Science Advisory Council for Exposure,
Standard Operating Procedure 9.1, Standard Values for Daily Acres
Treated in Agriculture, Rev. 25, September 2001.

3 Average Daily Dose (ADD) = Unit Exposure x Application Rate x Units
Treated x Absorption Factor ÷ Body Weight (80 kg).  Dermal absorption
factor = 21%, inhalation absorption factor = 100%.

4 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 1271 mg/kg/day, NOAELinhalation = 14.4 mg/kg/day for all
durations.

Short- and intermediate-term dermal exposures are predicted for
post-application exposure to workers performing typical agricultural
tasks.  Since flutianil-specific exposure data are not available,
post-application scenarios were assessed using Science Advisory Council
for Exposure (ExpoSAC) Policy 3 – Revised March 2013. The occupational
post-application exposure and risk estimates for flutianil are listed
below.

Occupational Post-Application Exposure & Risk Estimates for Flutianil 

Short- & Intermediate-Term Exposure	Crop

Activity	Transfer Coefficient1 (cm2/hr)	Application Rate

(lb ai/A)	Average Daily Dose2 (mg ai/kg bw/day)	Short- &
Intermediate-Term MOE3

Dermal	Strawberry

Hand Harvest	1,100	0.04	0.0026	490,000

Dermal	Cantaloupe, Cucumber, Summer Squash

Hand Set Irrigation	1,900	0.04	0.0045	280,000

Dermal	Apple, Cherry

Thinning Fruit	3,600	0.04	0.0085	150,000

Dermal	Grapes

Tying/Training, Hand Harvest, Leaf Pulling	10,100	0.04	0.024	53,000

1 Transfer Coefficient from   HYPERLINK
"http://www.epa.gov/pesticides/science/exposac-policy-3-march2013.pdf" 
Science Advisory Council for Exposure (ExpoSAC) Policy 3 – Revised
March 2013 .  PPE = long-sleeve shirt, long pants, socks, shoes.

3 Average Daily Dose (ADD) = Transfer Coefficient (TC) x Dislodgeable
Foliar Residue (DFR) x Duration * Absorption Factor ÷ Body Weight
(80 kg).  DFR = 25% * Application Rate, Duration = 8 hrs/day, Dermal
Absorption Factor = 21%.

4 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 1271 mg/kg/day for all durations.

All occupational handler and post-application exposures from
agricultural applications of flutianil result in MOEs greater than 100
and therefore do not exceed HED’s level of concern. 

	b.	Residential (Non-occupational) exposure and risk

There are no proposed uses of flutianil which would lead to direct
exposure to resident, either through mixing, loading and application, or
due to post application exposure; however, there are potential indirect
post-application exposures to adults and children due to drift onto
residential lawns from agricultural applications.  These indirect
post-application scenarios were assessed based on the proposed label for
GATTEN® fungicide (flutianil 5% liquid formulation) using draft
Residential Exposure Assessment Standard Operating Procedures - Addenda
1: Consideration of Spray Drift (November 1, 2013). The greatest
indirect residential exposure potential is from groundboom application
to cantaloupe, cucumber, summer squash or strawberries. The residential
post-application exposure and risk estimates for flutianil are listed
below.

Residential Exposure & Risk Estimates for Flutianil 

Short- & Intermediate-Term Exposure	Lifestage	Drift Application Rate1
(lb ai/A)	Average Daily Dose2 (mg ai/kg bw/day)	Short- &
Intermediate-Term MOE3

High Contact Lawn

Dermal	Adult	0.0075	0.00059	2,200,000

Dermal	1 to <2 years	0.0075	0.0012	1,100,000

Hand-to Mouth

Incidental Oral	1 to <2 years	0.0075	0.00011	11,000,000

Object-to-Mouth

Incidental Oral	1 to <2 years	0.0075	0.0000035	370,000,000

Soil Ingestion

Incidental Oral	1 to <2 years	0.0075	0.00000025	5,000,000,000



D.  	Cumulative Effects

Cumulative effects from substances with a common mechanism of toxicity:
Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide's residues and “other substances that have a
common mechanism of toxicity.”

 

Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to flutianil and any other
substances, and flutianil does not appear to produce a toxic metabolite
produced by other substances. Therefore for the purposes of this
tolerance action, EPA has not assumed that flutianil has a common
mechanism of toxicity with other substances.

E. 	Safety Factor for Infants and Children

In general, Section 408 of the FFDCA provides that EPA shall apply an
additional ten-fold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal toxicity
and the completeness of the database on toxicity and exposure unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of safety are incorporated into EPA risk
assessments either directly through use of a MOE analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.

Prenatal developmental toxicity studies in rabbits and rats showed no
qualitative/qualitative evidence of increased susceptibility in
offspring.  The 2-generation reproduction study in rats did not show
evidence of qualitative/qualitative evidence of increased susceptibility
in offspring.

The toxicology database for flutianil is complete. The data are
sufficient for endpoint selection for exposure/risk assessment scenarios
and for evaluation of the requirements under the Food Quality Protection
Act (FQPA). Evidence of quantitative and qualitative susceptibility of
offspring was not observed, and therefore, the FQPA 10x safety factor
was reduced to 1x.

F. 	Aggregate Risks and Determination of Safety

The proposed uses are the first uses proposed for flutianil in the
United States. 

Acute risk

An acute risk assessment was not performed. No toxicological endpoint
attributable to a single (acute) dietary exposure was identified.
Therefore, acute risk from flutianil exposure to is not expected.

Chronic risk

Using the exposure assumptions described in this unit for chronic
exposure, it was concluded that exposure to flutianil from food and
water will utilize 0.0% of the RfD for the U.S. population, and 0.1% of
the RfD for children 1-2 years old and children 3-5 years old, the
subpopulations at greatest exposure. Based on the use pattern, chronic
residential exposure to residues of flutianil is not expected.
Therefore, the aggregate exposure is not expected to exceed 100% of the
RfD.

Short-term risk

Short-term aggregate exposure takes into account residential exposure
plus chronic exposure to food and water. There are no proposed uses of
flutianil which would lead to direct exposure to resident, either
through mixing, loading and application or due to post application
exposure; however, there are potential indirect post-application
exposures to adults and children due to drift onto residential lawns
from agricultural applications.  Short-term aggregate exposure is not
expected to exceed the Agency's level of concern.

Intermediate-term risk

Intermediate-term aggregate exposure takes into account non-dietary,
non-occupational exposure plus chronic exposure to food and water.
Intermediate-term aggregate exposure is not expected to exceed the
Agency's level of concern.

Cancer risk 

Flutianil should be classified as, “Not likely to be carcinogenic in
humans.'' Flutianil is not expected to pose a cancer risk.

Determination of safety 

Based on these risk assessments, it is concluded that there is a
reasonable certainty that no harm will result to the general population
and to infants and children from aggregate exposure to flutianil
residues.

G.	 International Tolerances

Tolerances have been established in Japan for the following crops: 
eggplant (0.2 ppm), cucumber (including gherkin (0.2 ppm)), pumpkin
(including squash (0.05 ppm)), watermelon (0.05 ppm), melons (0.05 ppm)
and strawberry (0.5 ppm).  Tolerances have been established in Korea for
the following crops:  green and red pepper (0.5 ppm), strawberry (0.3
ppm), melon (0.05 ppm), watermelon (0.05 ppm), cucumber (0.05 ppm),
Korean melon (0.05 ppm) and sweet pepper (0.5 ppm). 

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