Document ID: EPA-HQ-OPP-2010-0297-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-05T04:00Z

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

<EPA Registration Division contact: [Shaunta Hill, 703/347-8961]>

<Arysta LifeScience North America, LLC>

<[0F7689]>

<	EPA has received a pesticide petition ([0F7689]) from <Arysta
LifeScience North America, LLC. 15401 Weston Parkway, Cary, NC 27513
>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 180.614 by
establishing tolerances for the residues of kasugamycin,
3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-tetradeoxy-α-D-arabi
no-hexopyranosyl]-D-chiro-inositol, in or on the following raw
agricultural commodities: fruiting vegetables (crop group 8 –fruiting
vegetables – except cucumber) at 0.15 parts per million (ppm), pome
fruit (crop group 11- pome fruit) at 0.25ppm, and walnuts at 0.04 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>

<Metabolism in plants. The metabolism of kasugamycin in tomato has been
investigated and is well understood as published in the Federal Register
of April 8, 2005 (67 FR 17997). The nature of residues of kasugamycin in
tomato was investigated using 14C radiolabeled kasugamycin. Parent
kasugamycin was the primary component in both fruit and foliage. The
main metabolite in fruit, present at a maximum level of 0.01 ppm, was
identified as kasugamycinic acid, resulting from the conversion of the
iminomethyl function to a carboxylic acid; conjugates of kasugamycin and
kasugamycinic acid were also found in fruit at very low levels. 
Investigation of extracts from foliage indicated the presence of
2-N-acetyl kasugamycin, kasuganobiosamine, and conjugates of kasugamycin
and kasugamycinic acid.

Metabolism in livestock.  The metabolism of kasugamycin in the lactating
goat has been investigated using 14C radiolabeled kasugamycin .and is
well understood 14C-kasugamycin was fed at an exaggerated level (14.4X)
of 12.6 mg/kg (dry feed basis) to a goat for 5 days. 

The majority of the label was excreted as unchanged kasugamycin in the
urine and feces.  Residues ranged from 0.003 ppm in skim milk to 0.024
ppm in milk fat. Residues in other tissues ranged from 0.002 ppm
(omental fat) to 0.013 ppm (liver). The kidney contained 0.262 ppm
kasugamycin. Of the residues found in kidney 92.9% was identified as
unchanged kasugamycin.

The goat study indicated that kasugamycin is poorly absorbed and those
residues that are retained comprise only parent compound.

>

<Analytical method.  A practical analytical method for detecting and
measuring levels of kasugamycin has been developed and validated in all
appropriate agricultural commodities. This analytical method is suitable
for monitoring of food with residues at the levels proposed for the
tolerances. The limit of quantitation (LOQ) for this method is 0.04 ppm.
An independent laboratory validation of the residue analytical method
was successful. 

>

<Magnitude of residue.  A total of 8 residue trials were conducted in
pears with 6 applications at 0.083lb ai/A, 7±1 days between
applications, and a 30 day PHI. The measured residues so obtained ranged
from 0.044 ppm to 0.172 ppm.  These results support a proposed tolerance
in pears of 0.25 ppm. 

As the proposed use pattern for pears is for 4 applications only, the
existing data for 6 applications are a conservative predictor of
potential residues following the proposed 4 applications, and the
proposed tolerance of 0.25 ppm for pears is protective.

A total of 24 Apple trials were conducted in both the U.S. and Canada
based on 4 applications at 0.083 lb ai/A, 7-days treatments intervals
and a 90 day PHI.  The measured residue values so obtained range from
<0.04 ppm to 0.075 ppm. All data are considered relevant to setting a
tolerance in the U.S. 

Decline data from a pear trail indicated that the dissipation of
kasugamycin residues from pome fruit is slow (1.3% per day). 
Anticipated residues for apples at a the 30 day PHI are calculated by
multiplying the residues measured at 90 days by the decline factor seen
over a 60 day interval (2.16). This calculation yields anticipated
residues at the proposed 30 day PHI are estimated to range from 0.099
ppm to 0.162 ppm

Based on the above analysis, it is reasonable to propose a pome fruit
crop group tolerance at 0.25 ppm (i.e., the value supported by the pear
data). 

Because quantifiable residues were not measured in the processing
studies with apples, default processing factors will be included in the
dietary exposure assessment to conservatively estimate potential
residues in processed apple commodities.

Twenty-four treated tomato samples were collected from 3 field trials.
Applications were made according to the proposed use pattern (i.e., 3
applications at ~0.021 lb ai/A with 7 day retreatment interval).
Tomatoes were harvested 1 day after the last application. No
quantifiable residues were measured in any of the treated samples.
Therefore, the tolerance for tomatoes is proposed at the limit of
quantitation (0.04 ppm). 

Because quantifiable residues were not measured in the processing
studies, default processing factors were included in the dietary
exposure assessment to conservatively estimate potential residues in
processed tomato commodities.

Nine trials (18 samples) were conducted in peppers (6 in bell pepper and
3 in non-bell peppers) according to the proposed use pattern (i.e., 3
applications at ~0.021 lb ai/A with 7±1 day retreatment interval). Two
trials were conducted in greenhouses, and the remaining trials were
conducted in the field. Peppers were harvested 1 day after the last
application. Quantifiable residues were detected in just 6 of the 18
samples, with measured residues ranging from <0.04 ppm to 0.107 ppm. 

The majority of the residue data (67%) were below the lower limit of
quantification so a direct consideration of the data is appropriate.
Residues in peppers range from <0.04 ppm to 0.107 ppm, so the proposed
tolerance for peppers is 0.15 ppm.

For the fruiting vegetable crop group, the proposed tolerances for
tomatoes and peppers are within 5X of each other, so a crop group
tolerance is feasible. The crop group tolerance for fruiting vegetables
is therefore based on the proposed tolerance for peppers of 0.15 ppm. 

The proposed tolerance of 0.15 ppm for fruiting vegetables will take
precedence over the existing import tolerance of 0.04 ppm for this crop
group.

Three field trials (6 samples) were conducted in walnuts according to
the proposed use pattern (i.e.,4 applications at 0.083 lb ai/A with 14
day retreatment interval). Walnuts were harvested approximately 100 days
after the last application. No quantifiable residues were measured in
any of the six treated samples. The tolerance for walnuts is proposed at
the limit of quantitation (0.04 ppm).

Assuming tolerance level residue of 0.25 ppm in treated apples, and
applying the maximum theoretical processing factor for apple pomace of
14X yields a kasugamycin residue level of 3.5 ppm kasugamycin.  Apple
pomace constitutes up to 10% of dairy cattle diets and is 40% moisture
(EPA, 2008), bringing the maximum dairy cattle diet burden to 0.875 ppm
kasugamycin. 

In a metabolism study in the lactating goat, 14C-kasugamycin was fed at
an exaggerated level (14.4X) of 12.6 mg/kg (dry feed basis) to a goat
for 5 days. Residues ranged from 0.003 ppm in skim milk to 0.024 ppm in
milk fat. Residues in other tissues ranged from 0.002 ppm (omental fat)
to 0.013 ppm (liver). The kidney contained 0.262 ppm kasugamycin. 

The residues in milk calculated using the 1X feeding level are
anticipated to range from 0.00014 ppm to 0.0017 ppm, and levels in other
tissues would range from 0.00021 ppm to 0.00090 ppm. Residues in kidney
could be anticipated to occur at up to  0.018 ppm. 

However, because apple pomace is generally fed only to dairy cattle and
these animals are not generally consumed, the main emphasis is on
anticipated residues in milk and milk products. Given the low
probability that these residues would ever occur, no tolerances for
dairy or meat products are necessary 

B. Toxicological Profile.  

Acute toxicity.  Kasugamycin has a low order of acute toxicity.  The
acute oral and dermal LD50 values for kasugamycin are greater than 5,000
milligrams per kilogram (mg/kg) for rats regardless of gender. In acute
inhalation testing in the rat, kasugamycin’s LC50 is greater than 2.07
milligram/liter (mg/L). Further Kasugamycin mildly irritating to the
eyes, and moderately irritating to the skin of rabbits, but was found to
be non-sensitizing to the skin of the guinea pig.  This technical label
will carry the EPA signal word ``CAUTION.'' >

<

Genotoxicity.  A battery of mutagenicity studies yielded negative
results in bacteria and mammalian cells; kasugamycin was negative in the
following assays:  Bacterial reverse mutation, Chinese hamster ovary
(CHO), chromosomal aberration (in vitro), mammalian erythrocyte
micronucleus, unscheduled DNA synthesis, and in vitro mammalian cell
gene mutation. Overall, it is unlikely that kasugamycin presents a
genetic hazard>

<Reproductive and developmental toxicity.  

i	Rat developmental.  In the developmental toxicity study conducted with
rats, for maternal toxicity the NOAEL is 200 mg/kg/day and the LOAEL is
1000 mg/kg/day based on decreased body weights, body weight gains, and
food consumption; increased incidence of loose stool; and distention of
the large intestine with stool in the cecum. 

 is ≥1000 mg/kg/day.

ii.	Rabbit developmental.  In the developmental toxicity study conducted
with rabbits, the maternal NOEL is 10 mg/kg/day and the LOAEL is ≥10
mg/kg/day.  It is noted that abortions and decreased maternal body
weights, body weight gains, and food consumption were seen at 30
mg/kg/day in a range-finding study. 

For developmental toxicity the NOAEL is 10 mg/kg/day and the LOAEL is
≥10 mg/kg/day.

iii.	Reproduction.  In the rat reproduction study the parental/systemic
NOAEL is 13.7/16.2 mg/kg/day (M/F) and the LOAEL is 70.3/82.9 mg/kg/day
(M/F) based on decreased body weights and body weight gains.  At
425.3/503.4 mg/kg/day (M/F), red and swollen skin around the anal
opening (M/F) and testicular atrophy/degeneration in Fl males were seen.

For reproductive toxicity the NOAEL is 70.3/82.9 mg/kg/day (M/F) and the
LOAEL is 425.3/503.4 mg/kg/day (M/F) based on decreased fertility and
fecundity in the F1 parents for both litters and increased pre-coital
interval during the mating period for the F2 litter. 

For offspring toxicity the NOAEL is 425.3/503.4 mg/kg/day (M/F) and the
LOAEL is ≥425.3/503.4 mg/kg/day (M/F)

Subchronic toxicity. 

i	Rat 90 day oral toxicity.  A thirteen week sub chronic feeding study
was conducted in the rat. The NOAEL is 176.7/201.0 mg/kg/day (M/F) and
the LOAEL is 354.8/395.5 mg/kg/day (M/F) based on decreased body weights
and body weight gains.

ii 	Rat 21 day dermal toxicity.  A 21 day dermal toxicity study was
conducted using Sprague Dawley rats as the test system. Based on the
results of this study, kasugamycin technical administered dermally for
6 hours per day, 7 days per week, for 21 consecutive days at a dosage
level of 500 mg/kg/day for males and 200 mg/kg/day for females exceeded
the tolerated dose due to adverse dermal observations with correlating
microscopic findings in both sexes.  Therefore, the dermal no-observed
adverse-effect level (NOAEL) for kasugamycin technical (expressed as the
free base) to Crl:CD(SD) rats was 250 mg/kg/day for males and 100
mg/kg/day for females.  The dermal no-observed-effect level (NOEL) was
50 mg/kg/day for males and females.  Based on the lack of systemic
effects, the systemic NOEL was 500 mg/kg/day for males and 200 mg/kg/day
for females, the highest dosage levels examined.

iii 	Rat 90 day dietary neurotoxicity.  Kasugamycin technical was
offered on a continuous basis in the diet for approximately 13 weeks to
groups of 12 male and 12 female Crl:CD(SD) rats at concentrations of
0, 300, 3000, and 6000 ppm.  Test substance-related effects were limited
to reduced mean body weights and body weight gains in the 6000 ppm group
males and females; the reduced mean body weights were evident during the
weekly and physiological FOB evaluations.  There were no test
substance-related effects on any parameters evaluated in the 300 and
3000 ppm groups.  Based on these results, the no-observed-adverse-effect
level (NOAEL) for subchronic toxicity was considered to be 3000 ppm for
males (210 mg/kg/day) and females (238 mg/kg/day) and the NOAEL for
subchronic neurotoxicity was considered to be 6000 ppm for males (439
mg/kg/day) and females (486 mg/kg/day) when kasugamycin technical was
offered on a continuous basis in the diet for approximately 90 days.

iv	Mouse 90 day oral toxicity.  A thirteen week sub chronic feeding
study was conducted in the mouse .The NOAEL is 135.4/170.9 mg/kg/day
(M/F) and the LOAEL is 408.5/565.6 mg/kg/day (M/F) based on increased
mortality and anal lesions (M/F), and kidney lesions (F). At 1559/1834
mg/kg/day (M/F), decreased body weights and body weight gains (M/F),
testicular tubular dilatation and degeneration, perianal/perigenital
staining (F), and extramedullary hematopoiesis of the spleen (M) were
seen

v	Dog 90 day oral toxicity.  A thirteen week sub chronic feeding study
was conducted in the dog. The NOAEL is 10.6/11.4 mg/kg/day (M/F) and the
LOAEL is 106.0/107.9 mg/kg/day (M/F) based on tongue lesions, few feces,
swollen mouth, excessive salivation, and thickened skin at the
commissure of the mouth. At 182/170 mg/kg/day (M/F), decreased body
weights, body weight gains, and food consumption were seen.

Chronic toxicity.  Kasugamycin has been tested in chronic studies with
dogs, rats, and mice.

Rat combined chronic toxicity/carcinogenicity.  In a 24-month combined
chronic/oncogenicity study in rats, findings were increased cecum
weights and kidney weights, increased brown pigment deposition in the
kidney proximal tubules and an increased incidence of foam cell
aggregation in the lungs. No significant increase in neoplastic lesions.
The NOEL is 300 ppm (10.59 mg/kg/day in males and 11.44 mg/kg/day in
females).

Carcinogenicity mouse.  Kasugamycin was administered at 1,500 ppm in the
diet to mice for 78 weeks. Observations were lower absolute and relative
spleen weights for males. The NOEL is 300 ppm (34.94 mg/kg/day in males
and 42.49 mg/kg/day in females).

Dog chronic toxicity.  Kasugamycin was administered for 52 weeks to
dogs. The administration of 3,000 ppm kasugamycin was associated with
minimally higher urea nitrogen and creatinine, lower urine volume, and
higher urine specific gravity. The NOEL is 1,000 ppm.

Carcinogenicity.  Kasugamycin did not produce carcinogenicity in
adequately designed chronic studies with rats or mice; additionally, no
mutagenic potential was noted in any of the five mutagenicity studies.
Classification of kasugamycin is ``not likely to be carcinogenic to
humans.

Animal metabolism.  The metabolism of kasugamycin in animals is well
understood. Following administration to the rodent, the majority of
kasugamycin is excreted into the feces, a small amount was eliminated in
the urine, and less than 0.1% of the radioactivity was retained in the
carcass.  Kasugamycin is not excreted in the bile and enterohepatic
circulation of kasugamycin does not occur. There were no apparent sex
related differences

Metabolite toxicology.  No metabolites of significant expected toxicity
were identified in the animal metabolism study

Endocrine disruption.  Beyond testicular softening seen in the rat
combined chronic toxicity/carcinogenicity study, there is no evidence
that kasugamycin has any effect on endocrine function.  >

<	>

<C. Aggregate Exposure>

<1. 	Dietary exposure.  Tier I chronic dietary exposure evaluations were
conducted for the active ingredient fungicide/bactericide, kasugamycin,
using the Dietary Exposure Evaluation Model (DEEM-FCID™, version
2.16), from Exponent, DEEM™.  Default processing factors were used in
these assessments.  All consumption data for these assessments was taken
from the USDA’s Continuing Survey of Food Intake by individuals
(CSFII) with the 1994-98 consumption database and the Supplemental CSFII
children’s survey (1998) consumption database.  These exposure
assessments included tolerance values as proposed for pending uses on
fruiting vegetables, pome fruit, and walnuts and assumed 100% of the
crops were treated.  Secondary residues in animal commodities were not
considered as anticipated residues and transfer information from
metabolism studies indicate that tolerances for kasugamycin in animal
commodities are not required.    Drinking water estimates were
incorporated directly into the dietary exposure assessment using the
value of 2.91 ppb derived for the surface water estimated drinking water
concentrations (EDWCs) using uses FIRST (FQPA Index Reservoir Screening
Tool) as the Tier I screening model for surface and ground water.  This
value was chosen for the risks assessment as it exceeds the 1.24 ppb
value obtained through use of SCI-GROW (Screening Concentration In
Ground Water) as the Tier I screening model.

For acute dietary exposures, no appropriate dose and endpoint could be
identified for females 13-49 or the general population. Consequently, an
acute dietary exposure assessment was not conducted.  

For chronic dietary exposures, the reference dose is 0.113 mg/kg/d,
based on the NOAEL for males (11.3 mg/kg/d) in the combined chronic
toxicity/oncogenicity study in rats and an uncertainty factor of 100. No
additional FQPA safety factor was applied.  The toxic effect of concern
is increased testicular softening observed in males at 116 mg/kg/d. No
effects were observed in females at the maximum dose (140 mg/kg/d).

Chronic exposure to the most exposed subpopulation (children 1-2 years)
resulted in exposure equivalent to 3.2% of the chronic RfD of 0.113
mg/kg-bw/day.  EPA generally has no concern for exposures below 100% of
the RfD, there is a reasonable certainty that no harm will result from
dietary (food) exposure to residues arising from the proposed uses for
kasugamycin

Cancer:  EPA classified kasugamycin as “not likely to be a human
carcinogen.”  Due to the classification, no quantitative cancer
exposure assessment was performed.

Non-dietary exposure.  

Occupational handler (mixer/loader/applicator) exposure.  Products
containing kasugamycin will be registered for agricultural uses only and
will not be available for any residential or public uses. Kasumin 2L
will be applied only by professionals; assessment of occupational
handler exposures potential post-application exposure is required. These
exposures are anticipated to be of short-term or intermediate-term
duration. Exposures associated with greenhouse uses were also evaluated
against the long-term toxicity endpoints. The exposure related hazards
are:

For dermal exposure of any duration, irritation was the effect of
concern. The NOAELs from a 21-day dermal study in rats are 250 mg/kg/d
and 100 mg/kg/day for males and females, respectively. The female NOAEL
was used in the risk characterization, and consequently the adult
occupational exposure assessment is based on the default female body
weight of 60 kg.

For inhalation exposures (short- and intermediate-term), the NOAELs from
the chronic oral dog study were selected. The NOAELs are 99.6 mg/kg/day
for males and 103.6 mg/kg/day for females (i.e., the highest doses
tested) from the chronic oral dog study. For simplicity, a NOAEL of 100
mg/kg/d was used in risk characterization. Complete absorption of
inhaled exposures is assumed.

For long-term inhalation exposures, the NOAEL from the chronic
toxicity/oncogenicity study in rats was selected (i.e., 11.3 kg/kg/day).

Applications of Kasumin 2L to pome fruit, fruiting vegetables and
walnuts will be made with either airblast (pome fruit, walnuts) or
groundboom (fruiting vegetables) equipment. Applications to fruiting
vegetables in greenhouses may be made with hand-held equipment. 

The highest rates, maximum number of applications, shortest intervals
and shortest PHI on the proposed label were modeled individually for
handlers making applications to pome fruit, fruiting vegetables, and
walnuts.

EPA default assumptions for the maximum daily area treated were also
employed in the assessment; these being, 40 acres/day for airblast
applications and 80 acres/day for groundboom applications (EPA, 2001).
For handheld uses in greenhouses, the maximum spray volume applied is 40
gallons/day for backpack and low pressure handwand sprayers and 1000
gallons/day for high pressure handwand sprayers (EPA, 2001).  Dermal and
inhalation unit exposures were obtained from the PHED Surrogate Exposure
Guide (EPA, 1997). Handler exposure estimates assume a 60 kg body
weight. Complete (100%) absorption of inhaled exposures is assumed. A
dermal absorption fraction was not applied in the calculation because
the endpoint of concern is from a dermal toxicity study.

Short-/intermediate-term dermal and inhalation exposures and margins of
exposure (MOEs) calculated for occupational handlers applying
kasugamycin range from 5,420 to 788,000.  Short-/intermediate-term
dermal, and short-/intermediate-term inhalation MOEs range from 113,000
to 11,300,000. For hand-held applications, long-term dermal MOEs range
from 5,420 to 788,000, and long-term inhalation MOEs range from 12,800
to 1,280,000. 

MOEs greater than 100 indicate that occupational handler exposures
associated with applications of kasugamycin to pome fruit, fruiting
vegetables and walnuts are not of concern.

Occupational post-application exposure assessment.  A screening-level
occupational post-application assessment was performed assuming re-entry
into treated crops as soon as the sprays have dried.  A default
assumption of 20% was used to estimate initial DFRs on the day of
application. Because the restricted entry interval (REI) for kasugamycin
is 12 hours, workers may re-enter treated crops. For each crop, the
maximum transfer coefficient (TC) was selected, without regard to the
activity associated with the TC in order to produce a conservative
estimate of potential re-entry exposures. 

For pome fruit, the maximum transfer coefficient is 3,000 cm2//hr for
thinning and other activities (EPA, 2006). 

For fruiting vegetables, the maximum transfer coefficient is 1,000 cm
cm2//hr for pruning, hand harvest, staking, tying and other activities
(EPA, 2000).

For walnuts, the maximum transfer coefficient is 2,500 cm2//hr for
pruning and hand harvest, was selected for pruning immature plants (EPA,
2000).

Dermal exposures were estimated assuming an 8-hour workday. Calculated
MOEs for re-entry activities in the proposed crops range from 1,340 to
15,900.  MOEs greater than 100  indicate that workers can re-enter
treated crops as soon as the sprays have dried to perform maintenance
activities. Thus, the REI of 12 hours for kasugamycin is protective of
human health. 

The occupational exposure and risk assessments for the proposed uses of
Kasumin 2L formulation demonstrate MOEs greater than 100, and estimated
dietary exposures are below the chronic reference dose. Therefore, the
occupational and residential exposures associated with the proposed Use
of Kasumin 2L on pome fruit, fruiting vegetables and walnuts indicate a
reasonable certainty of no harm for exposed populations.

 D. Cumulative effects. 

Section 408(b)(2)(D)(v) 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'',  The EPA does not have, at this time,
available data to determine whether kasugamycin has a common mechanism
of toxicity with other substances or how to include this pesticide in a
cumulative risk assessment.  For the purposes of this tolerance action,
the EPA has not assumed that kasugamycin has a common mechanism of
toxicity with other substances.

E. Safety determination. 

	1. U.S. population.  The chronic dietary exposure analysis (food plus
water) showed that exposure from all proposed uses of kasugamycin would
result in an exposure equal to 0.000698 mg/kg body wt/day (0.6% of the
acute RfD of 0.113 mg/kg/day) for the general US population.  A chronic
cancer exposure analysis was not performed, since there is no evidence
of human carcinogenic potential for Kasugamycin.  Short-term aggregate
and intermediate-term aggregate risk was not assessed because there are
no current, pending, or proposed residential uses for Kasugamycin. 
Based on the completeness and reliability of the toxicity data
supporting these petitions, there is a reasonable certainty that no harm
will result from aggregate exposure to residues arising from the
proposed kasugamycin tolerances, including anticipated dietary exposure
from food and water exposures.

	2. Infants and children.  The chronic dietary exposure analysis (food
plus water) showed that exposure from all established and proposed uses
of kasugamycin would in an exposure equal to 0.003573 mg/kg body wt/day
(3.2% of the acute RfD of 0.113 mg/kg/day)  for the most sensitive
subpopulation, children (1-2 years old). A chronic cancer exposure
analysis was not performed, since there is no evidence of human
carcinogenic potential for kasugamycin.  Short-term aggregate and
intermediate-term aggregate risk was not assessed because there are no
current, pending, or proposed residential uses for kasugamycin.  Based
on the completeness and reliability of the toxicity data supporting
these petitions, there is a reasonable certainty that no harm will
result from aggregate exposure to residues arising from all proposed
kasugamycin tolerances, including anticipated dietary exposure from food
and water exposures.  Considering the potential aggregate exposure from
food and water exposure routes, aggregate exposure is not expected to
exceed 100% of the chronic or acute reference dose and there is a
reasonable certainty that no harm will result to infants and children
from the aggregate exposure to kasugamycin.>

	

<F. International tolerances.  

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㄀Ĥ摧愓+	̤̀␱愁̤摧ㅫh

A

Kasugamycin is currently not included on Annex 1 and has a default MRL
of 0.01 within the EU.  

Japan has established MRLs as follows:  tomato  at 0.03 ppm; brown rice,
dried soybeans, dried beans, peas, broad beans, dried peanuts, other
legumes/pulses, potato, Japanese radish, roots (including radish),
Japanese radish, leaves (including radish), Chinese cabbage, cabbage ,
broccoli, other cruciferous vegetables, burdock, lettuce (including cos
lettuce and leaf lettuce), onion, welsh (including leek), garlic,
carrot, celery, pimento (sweet pepper), melons, Japanese pear, pear,
loquat, peach, mume plum, kiwifruit, and tea at 0.04 ppm; sugar beet,
turnip, roots (including rutabaga), turnip, leaves (including rutabaga),
watercress, brussels sprouts, kyona, cauliflower, shungiku, other
composite vegetables, mitsuba, other umbelliferous vegetables, other
solanaceous vegetables, cucumber (including gherkin), pumpkin (including
squash), water melon, other cucurbitaceous vegetables, okra, ginger,
other vegetables, unshu orange, pulp, citrus natsudaidai, whole, lemon,
orange (including navel orange), grapefruit, lime, other citrus fruits,
other fruits, other spices, and other herbs at 0.05 ppm>

<

>

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