FILE NAME: Valent.doc (Jan 7, 2010)

EPA Registration Division contac t: Kable (Bo) Davis (703-306-0415)

[Insert Petition Number]

Summary of Petition

EPA has received a pesticide petition (Inser t Petition Number) from Valent U.S.A. Corporation, P.O. Box 8025 Walnut Creek, CA 94596 (as Agent for Sumitomo Chemical Co., Ltd), proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to ame nd 40 CFR part 180, by establishing a timelimited tolerance for residues of the insecticide chemical clothianidin, ( E )-1-(2-chloro1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanid ine, in or on the following agricultural

commodities:

Commodity Proposed Tolerance Parts per million (For parent only unless indicated otherwise)

Rice Grain 0.01

EPA has determined that the petition contains data or information re garding the elements set forth in section 408(d)(2 ) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this tim e or whether the data supports granting of the petition. Additional data may be need ed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism . The metabolism of clothianidin is adequately understood for the purpose of granting the proposed tolerances.

2. Analytical method. Adequate enforcement methodology (liquid chromatography/mass spectroscopy/mass spectroscopy, LC/MS/MS analysis) is available to enforce the tolerance expression.

3. Magnitude of residues . A rational along with some residue data have been submitted which adequately support the requested tolerances.

B. Toxicological Profile

A complete, valid and reliable database of mammalian and genetic toxicology studies has been submitted to EPA that supports the proposed tolerances for clothianidin. The nature of the toxic effects caused by clothianidin, as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse e ffect level (LOAEL) from the toxicity studies reviewed, are discu ssed in the Federal Register of May 30, 2003 (68 FR 32390) (FRL-7306-8) [http://www.epa.gov/EPA-PE ST/2003/May/Day-30/p13564.htm and in theHED memorandum dated 8/13/2009 from Dr. Mi chael Doherty to Kable Davis/Venus Eagle “Clothianidin: Human Health Risk Assessment for Proposed Uses on Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14) , and Tuberous and Corm Vegetables (Group 1C). PC Code: 044309” (DP Barcodes: D355373, D362354).

C. Aggregate Exposure and Risk Assessment

i. Dietary Exposure. Dietary exposure (food and water) assessmen ts were conducted by EPA to evaluate the potential risk due to acute and chronic dietary e xposure of the U.S. population and various subgroups to combined residues of clot hianidin and its metabolite TMG plus residues of clothianidin resulti ng from the use of thiamethoxam. Residues from use of clothianidin on rice grain were not included in the current assessment because the contribution to the overall aggregat e exposure is considered negligible since the Experiment Use Permit is restricted to 40,000 acres (1.3 % of th e US planting acres),

and clothianidin residues are not detectable (<LOD of 5 ppb). Crop residues for rice grain will be included in the aggregate exposure assessment upon the establishment of permanent tolerances to support both foliar and seed treatment applications. Details of the model parameters can be found in the HE D risk assessment memorandum mentioned above (M. Doherty, D355373, D362354, 08/13/2009).

ii. Non-Dietary Exposure – residential/recr eational turf. Non- dietary exposure to

clothianidin from residential or recreati onal (turf grass) application scenarios was assessed using conservative residential adult a pplicator and post-application assumptions.

iii. Aggregate Assessment of Risks. The ag gregate acute risk assessment includes food, water and residential exposures. Because ch ronic exposure scenarios are not expected

from residential uses of cl othianidin, the chronic exposure risk assessment only includes food and water exposures. Residues from use of clothianidin on limited rice acres were

not included in the current assessment because the contribution to the overall aggregate exposure is considered negligible. Crop resi dues for rice grain will be included in the aggregate exposure assessment upon the establis hment of permanent tolerance to support foliar and seed treatment applications.

For acute risk assessment scenarios, the acute population adjust ed dose (aPAD) of 0.25 mg/kg was used to assess risks from acute dietary exposure to th e general population and to various sub-populations. The aPAD is ba sed on the NOAEL of 25 mg/kg/day from an acute neurotoxicity study (gener al population) or a developm ental toxicity study (females 13-49 years of age) with an FQ PA safety factor of 1.For chronic risk assessment scenarios, the ch ronic population adjusted dose (cPAD) used for the U.S. population and all subpopulations is 0.098 mg/kg/day based on a 2- generation reproduction study NOAEL of 9.8 mg/kg/day and an FQ PA safety factor of 1.

Based on these risk assessments, the margin s of exposure (MOE) for all routes of exposure and all population subgroups exceed 100 and therefore do not exceed EPA’s

level of concern.

D . Cumulative Effects. Section 408(b) (2) (D ) (v) requires that the Agency must consider available information concerning the cumulati ve effects of a particular pesticide's

residues and other substances that have a co mmon mechanism of toxici ty. Clothianidin is a member of the neonicotinoid class of pestic ides and is a metabolite of thiamethoxam.

Structural similarities or common effects do not constitute a common mechanism of toxicity and there is currently no eviden ce that neonicotinoids share a common mechanism of toxicity. For purposes of this petition, clothianidin residues from use of

clothianidin and thiamethoxam have been considered.

E. Safety Determination . The toxicological database for clothianidin is complete. The

available data indicate that there are no consis tent specific target organs in mammals. Based on the completeness of the database an d the observed effects, the FQPA Safety Factor has been reduced to 1X, leaving a 100X safety factor to account for within-species (10X) and across-species (10X) variability. Clot hianidin has been classified as not likely to be carcinogenic to humans.

The results of the aggregate exposure risk assessment indicate the MOE’s do not exceed

EPA’s level of concern. There is therefore a reasonable certainty that no harm will result to the general population or to any population subgroup resulting from aggregate exposure to residues of clothianidin.

F. International Tolerances Canadian maximum resi due limits (MRL) have been

established for residues of cl othianidin at 0.01 milligram/kilo gram (mg/kg) in milk, corn, canola, stone fruits, grape, pot ato and pome fruits. Clothianidin has not been evaluated by

the JMPR and there are no Codex Maximum Residue Limits (MRL) established.