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-Darabino-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

1 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.

2 Metabolism in livestock. The metabolism of kasugamycin in the lactating goat

has been investigated using 14C radiolabeled kasugamycin .and is well understood 14Ckasugamycin 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.
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The goat study indicated that kasugamycin is poorly absorbed and those residues that are 

retained comprise only parent compound.

3 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.

4 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.
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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. 

1. 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
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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 nonsensitizing to the skin of the guinea pig. This technical label will carry the EPA signal 

word ``CAUTION.''

2. 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

3. 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. 

For developmental toxicity the NOAEL is 1000 mg/kg/day and the LOAEL 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)
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4. 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 noobserved-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.
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5. Chronic toxicity. Kasugamycin has been tested in chronic studies with dogs, rats, 

and mice.

i. 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).

ii. 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).

iii. 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.

6. 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.

7. 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

8. Metabolite toxicology. No metabolites of significant expected toxicity were 

identified in the animal metabolism study

9. 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-FCIDTM, version 2.16), from Exponent, DEEMTM. 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 
7

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.

2. Non-dietary exposure. 

a. 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 intermediateterm 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.
8

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.

b. 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).
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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 reentry 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 
10

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. 

There are no Codex MRLs established for kasugamycin. 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