Document ID: EPA-HQ-OPP-2009-0814-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-06T05:00Z

Docket ID#: EPA-HQ-OPP-2009-0814

COMPANY NOTICE OF FILING 

EPA Registration Division contact: Sidney Jackson (703) 305-6224 

Interregional Research Project No. 4 (IR-4) in cooperation with Syngenta Crop Protection

PP9E7607

	EPA has received a pesticide petition PP9E7607 from the Interregional Research Project No. 4 (IR-4),  IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road east, Suite 201 W, Princeton, NJ 08540, in cooperation with Syngenta Crop Protection, Inc., 410 Swing Rd., Greensboro, NC 27419, 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 180.368 by establishing a tolerance for combined residues (free and bound) of S-metolachlor, S 2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-enantiomer, and its metabolites, determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound in or on the raw agricultural commodities: carrot, cucumber, okra,  sesame seed, sweet sorghum, leafy brassica greens subgroup 5B, turnip greens, melon crop subgroup 9A, caneberry crop subgroup 13-07A, blueberry, lowbush, bushberry crop subgroup 13-07B, onion, bulb subgroup 3-07A, and onion, green crop subgroup 3-07B  at 0.3, 0.1, 0.1, 0.1, 0.1, 1.2, 1.2, 0.08, 0.08, 1.4, 0.15, 0.1, and 2.0 parts per million (ppm), respectively.  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. Plant metabolism. The qualitative nature of S-metolachlor residues in plants is adequately understood based upon available EPA approved corn, potato, and soybean metabolism studies.  The metabolism of S-metolachlor involves conjugation with glutathione, breakage of this bond to form the mercaptan, conjugation of the mercaptan with glucuronic acid, hydrolysis of the methyl ether, and conjugation of the resultant alcohol with a neutral sugar.  EPA has determined that residues of concern in plants include parent and metabolites determined as the derivatives CGA-37913 and CGA-49751.

	2. Analytical method. The Pesticide Analytical Manual (PAM) Vol. II, Pesticide Regulation Section 180.368 lists a GC/NPD method (Method 1) for determining residues in / on plants and a GC/MSD method for determining residues in livestock commodities.  These methods determine residues of S-metolachlor and its metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.  The limit of quantitation (LOQ) for the method is 0.03 ppm for CGA-37913 and 0.05 ppm for CGA-49751. Syngenta has also developed a chiral specific analytical method to allow for the determination of residues that are specific to S-metolachlor.  It is this chiral specific method that Syngenta and IR-4 proposes for future use as the analytical enforcement method in support of these requested tolerances. Syngenta No. 1848-01 was used in several of the studies in this petition to analyze agricultural commodities.  The latter chiral specific method is the same as the updated tolerance enforcement method, except that chiral chromatography and LC/MS/MS are used to separate and quantitate the hydrolysis products SYN506357 (s-configured enantiomer of CGA-37913) and SYN508500 (s-configured enantiomer of CGA-49751).

	3. Magnitude of residues. Carrot: Fourteen magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 1A (PEI; one trial), Region 4 (FL and GA, one trial each), Region 5 (ON, two trials; QC, two trials; & WI, one trial), Region 6 (TX, one trial), Region 9 (CA, four trials) and Region 10 (WA, one trial). Foliar applications at 0.63 or 1.26 lbs ai/A were made postemergence at the 3-5 leaf growth stage during 2004. Carrots were harvested at normal maturity ranging from 26-121 days after application.  Total maximum residues in carrots  were <0.28 ppm when treated with the highest application rate. 
Cucumber: Fifteen magnitude of residue trials were conducted under the direction of IR-4 in Region 3 (MD, one trial), Region 4 (TN, NC, FL, and GA, one trial each), Region 5 (ON, three trials; QC, two trials), Region 6 (NM & TS, one trial each), and Region 10 (BC, three trials).  Foliar applications at 0.63 or 1.2 lbs ai/A were made postemergence at the 3-5 leaf growth stage during 2005.  Cucumbers were harvested at normal maturity ranging from 32-52 days after application.  Total maximum residues in cucumbers were <0.1 ppm when treated with the highest application rate.
Okra: A tolerance is being proposed at 0.1 ppm based upon already existing tolerance in Vegetable, Fruiting Crop Group 8 (except Tabasco pepper).
Sesame seed: Four magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 6 (TX, four trials) on sesame.  Applications were made as a preemergence broadcast application prior to crop emergence.  Sesame seed were harvested at normal maturity ranging from 101-128 days after application.  In addition, at one site a bulk sample was collected for processing. Total maximum residues in sesame seed from preemergence applications was <0.10 ppm.  Total maximum residues from processed sesame seed (processed fractions were oil and meal) was <0.1 ppm indicating that there is no potential for concentration of residues in the processed commodities of sesame seed.
Sweet sorghum: Three magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 4 (TN, two trials) and Region 6 (TX, one trial) on sweet sorghum.  Applications were made preemergence broadcast prior to crop emergence at 1.0 or 1.67 lbs ai/A or early postemergence at 0.64 or 1.27 lbs ai/A.  Sweet sorghum was harvested at normal maturity ranging from 87-108 days after application.  In addition, at one site (TX) a bulk sample from the control and high treatment rate plot was collected for processing into syrup. Total maximum residues in sweet sorghum from preemergence applications or postemergence applications was <0.1 ppm.  Total maximum residues from processed sweet sorghum (molasses) was <0.15 ppm indicating that there is no potential for concentration of residues in the processed commodities of sweet sorghum.
Leafy Brassica Greens Crop Group 5B
Mustard Greens: Twelve magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 2 (NC-two trials; NJ-one trial), Region 3 (FL-one trial) Region 4 (TN-one trial), Region 5 (MI-one trial, ON-two trials), Region 6 (TX, one trial), Region 10 (CA, two trials) and Region 12 (BC, one trial) on mustard greens during 2004-2005.  Applications were made at 0.63 or 1.26 lbs ai/A preemergence or early postemergence as a broadcast application.   Harvests were made at normal maturity ranging from 20-40 days after the early postemergence applications and 33-62 days after the preemergence applications.  Total maximum residues in mustard greens ranged from 0.17-0.18 ppm at the low application rate and 0.43-0.67 ppm at the high application rate.  This data supports the leafy brassica greens, subgroup 5-B and turnip greens proposed tolerances.
Turnip Greens: A tolerance is being proposed at 1.2 ppm based on proposed tolerance for Leafy Brassica Greens Crop Group 5B. 
Melon Crop Group 9A:
Cantaloupe: Eleven magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 2 (NJ; one trial), Region 4 (NC, one trial) Region 5 (MI, ON; one trial each), Region 5B (ON, one trial), Region 8 (TX, two trials), Region 10 (CA, three trials; NM, one trial) on cantaloupe during 2003.  Applications were made at 2 lbs ai/A 1] preemergence as a broadcast application to the row middles after laying plastic mulch or 2) preemergence or before transplanting prior to the laying the plastic mulch.   Fruit were harvested at normal maturity ranging from 61-112 days after application.  Total maximum residues in cantaloupe were <0.08 ppm regardless of the application method or timing.  
Caneberry Crop Group 13-07A: Five magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 1 (PA, one trial, red raspberry), Region 5 (MI, one trial, red raspberry), and Region 12 (OR, three trials, one blackberry and two red raspberry) on cane berries.  A single post-directed banded application was made preemergence to the weeds and fruit were harvested at normal maturity 28-30 days after application.  Total maximum residues in cane berries from a single banded application was <0.08 ppm.  
Bushberry Crop Group 13-07B: Eleven magnitude of residue trials were conducted under the direction of IR-4 in NAFTA Region 1, 2, 5, 10, 12 and PMRA Regions 5b and 12 on blueberry.  In highbush blueberry, a single post-directed banded application was made preemergence to the weeds and fruit were harvested at normal maturity 27-33 days after application. In lowbush blueberry, a single broadcast application was made preemergence to the weeds and fruit were harvested at normal maturity 27-33 days after application. Total maximum residues in bushberry from a single application was <0.04 ppm.
Onion, bulb Crop Subgroup 3-07A and Onion, dry Crop Subgroup 3-07B: requested tolerances are based on existing tolerances for s-metolachlor on onion, dry bulb (0.1 ppm) and onion, green (2.0 ppm).

B. Toxicological Profile

	1. Acute toxicity.  The data base for acute toxicity for S-metolachlor is complete.  S-metolachlor is moderately acutely toxic (Toxicity Category III) by the oral and dermal route and relatively non-toxic (Toxicity category IV) by the inhalation route.  It causes slight eye irritation (Toxicity Category III) and is non-irritating dermally (Toxicity Category IV); the active ingredient was found to be positive in a dermal sensitization test but this effect is mitigated in end-use product formulations.

	2. Genotoxicty. The data base for S-metolachlor has been deemed to be adequate by EPA.  Gene mutation studies (Guideline 870.5100), micronucleus (Guideline 870.5395), and unscheduled DNA synthesis (Guideline 870.5550) studies have recently been reviewed and approved by EPA.  There is no evidence of a mutagenic or cytogentic effect in vivo or in vitro with S-metolachlor.

	3. Reproductive and developmental toxicity. The data base for developmental and reproductive toxicity for S-metolachlor are considered complete according to EPA reviews.  The prenatal developmental studies in the rat and rabbit with S-metolachlor revealed no evidence of a qualitative or quantitative susceptibility in fetal animals.  No significant developmental toxicity was observed in most studies even at the highest does tested.   In a two-generation reproduction study, there was no evidence of parental or reproductive toxicity at the highest dose tested (80 mg/kg/day).  The results indicate that S-metolachlor is not embryotoxic or teratogenic in either species at maternally toxic doses.

	4. Subchronic toxicity. In a 90-day dietary study in rats with S-metolachlor, no effects were observed in male or females at 208 and 236 mg/kg/day, respectively.  In another 90-day dietary study in rats, decreased body weight, reduced food consumption and food efficiency in both sexes and increased kidney weight in males at 150 mg/kg/day; the NOAEL was 15 mg/kg/day.  A 90-day dog study with S-metolachlor in dogs has been accepted by EPA; no effects were observed in males and females at 62 mg/kg/day and 74 mg/kg/day, respectively, the highest doses tested.

	5. Chronic toxicity. The data base that supports S-metolachlor is considered adequate by EPA.  A combined chronic toxicity / carcinogenic study in the rat satisfies the requirements for both the chronic toxicity and carcinogenicity studies.  No significant chronic toxicity was found in either rats or dogs.  In the rat, a decrease in body weight was observed at the highest dose tested.  In the chronic dog study that supports S-metolachlor, the only adverse effect was decreased body weight gain in females at 33 mg/kg/day; the NOAEL was 10 mg/kg/day.

	6. Animal metabolism. The data base for S-metolachlor is considered to be complete.  In animals, S-metolachlor is extensively absorbed, rapidly metabolized and almost totally eliminated in the excreta of rats, goats, and poultry.  Metabolism in animals proceeds through common Phase 1 intermediates and glutathione conjugation.

	7. Metabolite toxicology. The metabolism of S-metolachlor has been well characterized in standard FIFRA metabolism studies.   S-metolachlor does not readily undergo dealkylation to form an aniline or quinone imine as has been reported for other members of the chloroacetanilide class of chemicals.  Therefore, as EPA has agreed, it is not appropriate to include S-metolachlor with the group of chloroacetanilides that readily undergo dealkylation, producing a common toxic metabolite (quinone imine).  EPA has recently reviewed new toxicology data submitted by Syngenta demonstrating that the S-metolachlor metabolites ethane sulfonic acid (CGA 354743) and oxanilic acid (CGA 51202) are not absorbed by mammalian systems and / or have a significantly lower level of mammalian toxicity when compared to parent.

	8. Endocrine disruption. S-Metolachlor does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system.  There is no evidence that S-metolachlor has any effect on endocrine function in developmental or reproduction studies.  Furthermore, histological investigation of endocrine organs in the chronic dog, rat and mouse studies did not indicate that the endocrine system is targeted by S-metolachlor, even at maximally tolerated doses administered for a lifetime.  There is no evidence that S-metolachlor bioaccumulates in the environment.

C. Aggregate Exposure

	1. Dietary exposure. Acute (Tier I) and chronic (Tier III/IV) dietary exposure evaluations were made for S-metolachlor using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID(TM), version 7.87) from Exponent.  All consumption data for these assessments was taken from the USDA's Continuing Survey of Food Intake by individuals (CSFII) with the 1994-96 consumption database and the Supplemental CSFII children's survey (1998) consumption database.  The acute exposure assessment was based on all established and proposed tolerances for S-metolachlor and the percent of crop treated was assumed to be 100% for all commodities.  Proposed S-metolachlor tolerances include carrot, cucumber, okra, sesame seed, sweet sorghum, leafy brassica greens subgroup 5B, melon crop subgroup 9A, caneberry crop subgroup 13A, bushberry crop subgroup 13B, and Onion bulb subgroup 3-07A and 3-07B.  The chronic exposure assessment was based on field trial residues, UDSA-PDP residues and Syngenta's 1999-2000 Market Basket Survey  (SMBS) residues.  For the chronic assessment, field trial residues were averaged and entered into the DEEM-FCID(TM) software with an adjustment for percent of crop treated if such information was available.  The percent of crop treated was assumed to be 100% for the market basket data and for all commodities for which no percent of crop treated information was available.

	i. Food. Acute Risk.  The acute dietary risk assessment was performed for all population subgroups with an acute reference dose of 3.0 mg/kg-bw/day based on an acute no observable adverse effect level (NOAEL) of 300 mg/kg/day prenatal developmental toxicity study in rats and an uncertainly factor of 100X.  The 100X safety factor includes intra- and interspecies variations.  No additional FQPA safety factor was applied.  The acute assessment was run using DEEM-FCID(TM) software using established and proposed tolerances for S-metolachlor and 100% crop treated value.  For the purpose of the aggregate risk assessment, the exposure value was expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was expressed as a percent of the acute reference dose (%aRfD).  Acute food (alone) exposure to the U.S. population resulted in a MOE of 71,317 (0.14 % of the acute RfD of 3.0 mg/kg-bw/day).  Acute food (alone) exposure to the most sensitive subpopulation (children 1 to 2 years old) resulted in a MOE of 35,110 (0.28% of the acute RfD of 3.0 mg/kg-bw/day).  Since the benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute dietary (food) exposure to residues arising from the current and proposed uses for S-metolachlor.

Chronic Risk.  The chronic assessment was run using DEEM-FCID(TM) software using average field trial residue values, USDA-PDP residues and SMBS data for all current and proposed crop registrations.  The chronic dietary risk assessment was performed for all population subgroups with a chronic reference dose of 0.1 mg/kg-bw/day based on a one-year feeding study in dogs with a NOAEL of 9.7 mg/kg/day and an uncertainly factor of 100X.  The 100-fold safety factor includes intra- and interspecies variations.  No additional FQPA safety factor was applied.  For the purpose of the aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was expressed as a percent of the reference dose (%RfD).  Chronic food (alone) exposure to the U.S. population resulted in a MOE of 34,761 (0.3% of the chronic RfD of 0.1 mg/kg-bw/day).  Chronic food (alone) exposure to the most exposed sub-population (children, 1-2 years old) resulted in a MOE of 14,616 (0.7% of the chronic RfD of 0.1 mg/kg-bw/day).  Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary (food) exposure to residues arising from the current and proposed uses for S-metolachlor.

Cancer.  S-metolachlor has been classified as a Group C, possible human carcinogen based on the occurrence of liver tumors in rats.  The NOAEL that was established based on tumors in rats (15 mg/kg/day) is comparable to the NOAEL of 9.7 mg/kg/day selected for the chronic reference dose.  Therefore the chronic dietary end point is protective for cancer dietary (food and water) exposure.

	ii. Drinking water. [The estimated drinking water concentrations (EDWCs) for surface water and groundwater were taken from monitoring data from two National Water Quality Assessment (NAWQA) programs.  The maximum concentration of parent metolachlor / S-metolachlor detected in a nationwide NAWQA surface water monitoring program (that did not analyze for the degradates) was used as the peak surface water EDWC for the acute assessment; the maximum time-weighted mean from the same database was used as the chronic surface water EDWC.  For the metolachlor ethanesulfonic acid (ESA) and metolachlor oxanilic acid (OA) metabolites, maximum surface water concentrations from a NAWQA monitoring program (that collected both surface and groundwater data on parent metolachlor / S-metolachlor and the ESA and OA degradates) in the midwest cornbelt states of Iowa and Illinois were used as peak surface water EDWCs for the acute assessment; maximum time weighted means were used as the chronic surface water EDWCs.  All groundwater EDWCs were taken from the NAWQA Iowa / Illinois monitoring program.  Maximum (upper bound) detections of parent metolachlor / S-metolachlor and the ESA and OA metabolites from the groundwater monitoring were used for both acute and chronic groundwater EDWCs since weighted means were not available.

For surface water, the EDWCs of parent metolachlor / S-metolachlor and its degradates for acute exposures were estimated to be 96.75 ppb for surface water (parent: 77.6 ppb, ESA: 12.4 ppb, and OA: 6.75 ppb) and 109.9 ppb for ground water (parent: 32.8 ppb, ESA: 63.7 ppb, and OA: 13.4 ppb).  The EDWCs for chronic exposures were estimated to be 13.87 ppb for surface water (parent: 4.3 ppb, ESA: 7.3 ppb, and OA: 2.27 ppb) and 109.9 ppb for ground water (parent: 32.8 ppb, ESA: 63.7 ppb, and OA: 13.4 ppb).  

Acute Exposure from Drinking Water.  The acute EDWC of 109.9 ppb for ground water was used directly in the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the acute drinking water exposures.  The acute drinking water exposure contributions at the 95%-ile of exposures were determined by taking the difference between the aggregate (food + drinking water) exposures and the food (alone) exposures for each population subgroups.  Acute drinking water exposure to the U.S. population resulted in a MOE of 63,884 (0.16% of the acute RfD of 3.0 mg/kg-bw/day).  Acute drinking water exposure to the most exposed sub-population (infants, <1 year old) resulted in a MOE of 17,133 (0.58% of the acute RfD of 3.0 mg/kg-bw/day).  Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the acute RfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute drinking water exposure to residues arising from the current and proposed uses for S-metolachlor.

Chronic Exposure from Drinking Water.  The predicted chronic ground water value of 109.9 ppb was input directly into the DEEM-FCID(TM) software as water, direct and indirect, all sources to model the chronic drinking water exposure.  Chronic drinking water exposure to the U.S. population resulted in a MOE of 4,187 (2.30% of the chronic RfD of 0.1 mg/kg-bw/day).  Chronic drinking water exposure to the most exposed sub-population (infants, <1 year old) resulted in a MOE of 1,277 (7.6% of the chronic RfD of 0.1 mg/kg-bw/day).  Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the chronic RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposure to residues arising from the current and proposed uses for S-metolachlor.

	2. Non-dietary exposure. There is a potential for post-application exposure to adults and children resulting from the use of S-metolachlor on residential lawns.  Post-application exposure is considered to be short-term based on label directions limiting application to one time per season.  Since toxicity was not observed in a dermal toxicity study, up to a dose level of 1,000 mg/kg/day, the only parameter of short-term residential risk that needs to be addressed is the possible oral exposure of toddlers and children from treated turf or soil.  For aggregate risk assessments, the EPA recommended using the three scenarios (hand-to-mouth, object-to-mouth, soil ingestion) combined.  Using these exposure assumptions for short-term exposures, the EPA has concluded that aggregated food and residential exposures from metolachlor/S-metolachlor result in an aggregate MOE of 991 for children, 1-6 years.  Note that there are no non-dietary contributions to the aggregate MOE for adults or infants (<1 year) from turf uses since none of the oral exposure scenarios (hand-to-mouth, object-to-mouth, soil ingestion) would be applicable to these population subgroups.

D. Cumulative Effects

	Cumulative Exposure to Substances With a Common Mechanism of Toxicity.  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".  EPA has examined the common mechanism potential for S-metolachlor and has concluded that S-metolachlor should not be included with the chloroacetanilide pesticides designated as a "Common Mechanism Group."  The Agency's position is that only some chloroacetanilides, namely acetochlor, alachlor and butachlor should be considered as a "Common Mechanism Group" due to their ability to cause nasal turbinate tumors.

E. Safety Determination

	1. U.S. population. Using the conservative assumptions described above, and based on the completeness and reliability of the toxicity data, the acute aggregate exposure calculation for current and proposed uses of S-metolachlor provided a MOE of 33,698 (0.3% of the acute RfD of 3.0 mg/kg-bw/day) for the U.S. population.  The chronic aggregate exposure calculation for current and proposed uses of S-metolachlor provided a MOE of 3,738 (2.6% of the chronic RfD of 0.1 mg/kg-bw/day) for the U.S. population.  Since the aggregate MOEs exceed the benchmark MOE of 100, Syngenta believes that there is a reasonable certainty that no harm will occur to the U.S. Population from acute or chronic aggregate exposures arising from the current and proposed uses for S-metolachlor.

	2. Infants and children. Using the conservative assumptions described in the exposure section above, and based on the completeness and reliability of the toxicity data, the acute aggregate exposure calculation for current and proposed uses of S-metolachlor provided a MOE of 12,065 (0.83% of the acute RfD of 3.0 mg/kg-bw/day) for the infants < 1 year old (the most sensitive population subgroup for the acute assessment).  The chronic aggregate exposure calculation for current and proposed uses of S-metolachlor provided a MOE of 1,215 (8.0% of the chronic RfD of 0.1 mg/kg-bw/day) for the infants < 1 year old (the most sensitive population subgroup for the chronic assessment).  Since the aggregate MOEs exceed the benchmark MOE of 100, Syngenta believes that there is a reasonable certainty that no harm will occur to infants and children from acute or chronic aggregate exposures arising from the current and proposed uses for S-metolachlor.

F. International Tolerances

	There are currently no Maximum Residue Limits (MRLs) set for S-metolachlor for crops by the Codex Alimentarius Commission.  International MRLs for the herbicide S-metolachlor have been established for various agricultural commodities in a number of countries including Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Italy, Japan, Korea (South), Luxembourg, Malaysia, Moldova, Morocco, Netherlands, New Zealand, Russia, Serbia and Montenegro, Slovak Republic, Slovenia, Spain, Switzerland, Taiwan, and Ukraine.