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 p esticide petition ( [ 0F 7689 ] ) from Arysta LifeScience North Am erica, LLC. 15401 Weston Pa rkway, 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 e s tablishing tolerance s for the residue s of kasugamycin, 3
- O
- [2
- amino
- 4
- [(carboxyiminomethyl)amino]
- 2,3,4,6
- tetradeoxy- α- D
arabino
-hexopy

ranos yl ]
- D
- chiro
- inositol , in or on the following raw agricultural commodities: fruiting ve getables (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 o f the submitted data at this time or whether the data supports granting of the petition. Additional data may b e needed before EPA rules on the petition. A. Residue Chemistry 1 M eta bolism in plants
. The metabolism of kasugamycin in tomato has been investigated and is well understood as published in the Federal Register of April 8 , 200 5 (67 FR 17997). The nature of residues of kasugamycin in tomato was investigated using 14 C radiolabe led kasugamycin. Parent kasugamycin was the primary c omponent 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 carboxyl ic acid ; conjugates of kasugamycin and kasugamyc inic acid were als o found in fruit at very l ow levels. Investigation of extracts from foliage indicated the presence of 2
-N
- acetyl kasugamycin, kasuganobiosamine, and c onjugates of kasugamycin and kasugamycinic acid.
2 Metabolism in livestock. The metabolism of kasugamycin in the lactating goat has been investigated using 14 C radiolabeled kasugamycin
. and is well understood 14 C
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.2

The goat study indicated that kasugamycin is poorly absorbed and those residues that are retained comprise only parent compound. 3 Analytical method

. A practical anal ytical 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 v alidation of the residue anal ytical 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 P HI
. The measured residues so obtained range d 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 P HI 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 rea sonable 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 e xposure 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 a fter 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 quantitati on (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 e stimate potential residues in processed tomato commodities.3

Nine tri als (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 a fter 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 ve getable 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). A ssuming tolerance l evel residue of 0.25 ppm in treated apples, and applying the maximum theoretical processing factor for apple pomace of 14X yi elds a kasugamycin residue level of 3.5 ppm kasugamycin
. Apple pomace constitutes up to 10% of dairy c attle diets and is 40% moisture (EPA, 2008), bringing the maximum dairy c attle diet burden to 0.875 ppm kasugamycin. In a metabolism study

in the lactating goat, 14 C
- kasugamycin was fed at an exaggerated level (14.4X) o f 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 us ing 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 pro ducts are necessary B. Toxicological Profile
. 1. Acute toxicity. Kasugamycin has a low order of acute toxicity
. The acute oral and dermal LD 50 values for kasugamycin are greater than 5 ,000 milligrams per kilogram (mg/kg) for rat s regardless of gender
. In acute inhalation testing in the rat, kasugamycin’s4

LC 50 is greater than 2.07 milligram/liter (mg/L)
. Further Kasugamycin mildly irritating to the eye s, 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 .'' 2. Genotoxicity. A battery o f mutagenicity

s tudies yi elded negative results in bacteria and mammalian cells ; kasugamycin was negative in the following assays: Bacterial rev erse mutation, Chinese hamster ovary ( CHO), chromosomal aberration (in vitro), mammalian erythrocy te micronucleus, unscheduled DNA sy nthesis, and in vitro mammalian cell gene mutation. Overall, it is unlikely that kasugamycin presents a genetic hazard 3. R eproductive and developmental toxicity. i Rat developmental
. In the developmental toxicity s tudy c onducted with rats , for maternal toxicity

the NOAEL is 200 mg/kg/day and the LOAEL is 1000 mg/kg/day based on decreased body w eights, body

w eight 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 gain s, 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
. Inthe 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 LO AEL is ≥425.3/503.4 mg/kg/day

(M/F)5

4. Subchronic toxicity. i R at 90 day oral toxicity
. A thirteen week sub chronic feeding study w as conducted in the rat. The NOAEL is 176.7/201.0 mg/kg/day (M/F) and the LO AEL 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

s tudy was conducted using Sprague D awley rats as the test system. Ba sed 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 f or males and 200 mg/kg/day f or females exceeded the tolerated dose due to advers e dermal observations with correlating microscopic findings in both sexes. Therefore, the dermal no - observed adverse
- effect level (NOAE L) 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 f or females. The dermal no observed
- effect level (NOEL) was 50 mg/kg/day for males and females. B ased on the lack of systemic effects, the systemic NOE L was 500 mg/kg/day f or males and 200 mg/kg/day

for females, the highest dosage levels examined. i i i Rat 90 day dietary neurotoxicity
. Kasugamycin technical was offered on a continuous basis in the diet for approximately 1 3 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 w eights and body

w eight 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 p arameters 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 NOAELf or 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 w as 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 l esions (F). At 1559/1834 mg/kg/day (M/F), decreas ed body

w eights 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 s tudy 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 .6

5. Chronic toxicity. Kasugamycin has been tested in chronic studies with dogs, rats, and mice. i. Rat combined chronic toxicity/ carcinogenicity
. Ina

2 4
- month combined chronic/oncogenicity

s tudy in rats , findings were increased cecum weights and kidne y 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 neoplas tic lesions. The NOEL is 300 ppm (10.59 mg/kg/day in males and 11.44 mg/kg/day

in females). ii. Carcinogenicity m ouse . 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 wa s noted in any

o f the five mutagenicity s tudies. 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 o f 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 o ccur. 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 chroni c toxicity

/carcinogenicity

study, there is no evidence that kasugamyc in has any effect on endocrine function. C. Aggregate Exposure 1. Dietary exposure. Tier I chronic dietary exposure evaluations were conducted for the active ingredient fungi cide/ bactericide, kasugamycin , using the Dietary Exposure Evaluation Model (DEEM
- FCID TM , version 2.1 6 ), from Exponent , DEEMTM
. Default processing factors were used in these assessments. All consumption data for these assessments was taken from the USDA’s C ontinuing Survey o f Food Intake by individuals (CSFII) with the 1994
- 9 8 consumption database and the Supplemental CSFII7

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 F IR ST (FQPA In dex 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 InGround 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

e xposures, 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

f actor of 100. No additional FQPA safety f actor was applied
. The toxic effect of conc ern is increased testicular softening observed in males at 116 mg/kg/d. No ef fects were observed in females at the maximum dose (140 mg/kg/d)
. Chronic exposure to the most exposed subpopulation (children 1
- 2 ye ars) 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 C ancer: 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 onl y and will not be available for any residential or public uses. Kasumin 2L will be applied only by professionals ; a ssessment of occupational handler exposures potential p ost- application exp osure 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 expo sure 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 ad ult occupational exposure assessment is b ased on the default female body w eight 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 f or 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 f or groundboom appl ications (EPA, 2001). For handheld uses in greenhouses, the maximum spray volume applied is 40 gallons/day f or backpack and low pressure handwand sprayers and 1000 gallons/day

f or high pressure handwand sprayers (EPA, 2001). D ermal and inhalation unit exp osures 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 1 00 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

o f 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).9

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 e

ffects
. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency c onsider ``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. F or the purposes of this tolerance action, the EPA has not assumed that kasugamycin has a common mechanism of toxicity with other substances. E. Safety d

etermination
. 1. U.S. population
. The chronic dietary exposure anal ys is (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 anal ys is was not performed, since there is no evidence of human carcinogenic potential for Kasugamycin . S hort
- term aggregate and intermediate
- term aggregate risk was not assessed because there are no current, pending, or proposed residential uses for Kasugamycin
. B ased on the completeness and reliability o f the toxicity

data supporting these petitions, there is a rea sonable 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 kasugamyc in 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 subpopul ation, children (1
- 2 years old). A chronic10

cancer exposure anal ys is was not performed, since there is no evidence of human carcinogenic potential for kasugamycin
. S hort
- term aggregate and intermediate
- term aggregate risk was not assessed because there are no current, pending, or proposed residential uses for kasugamycin
. B ased on the completeness and reliability o f 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. C onsidering the potential aggregate exposure from food and water exposure routes , ag gregate 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 currentl y not included on Annex 1 and has a default MRLof 0.01 within the EU
. Japan has established MRL s as follows: tomato at 0.03 ppm; brown rice, dried s oy beans, dried b eans, peas, broad beans, dried p eanuts, other legumes/pulses, p otato, 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), garli c, 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, caul iflower, 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, un shu 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