Valent U.S.A. Corporation V
- 37696 Page 6 of 117 FILE NAME: Valent. doc ( Jan uary 20, 2011 ) EPA Registration Division contact: Venus Eagle (703
-308
-8045 ) [Insert Petition Number] amend 40 CFR Summary of Petition EPA has received a pesticide petitio n (Insert Petition Number) from Valent U.S.A. Corporation , P.O. Box 8025 W alnut 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 amend 40 CFR part 180.586 (a) , by establishing a tolerance for residues of the insecticide chemical clothianidin, ( E)
- 1
- (2
-chloro
- 1,3
-thiazol
-5
-ylmethyl)
-3
- methyl
-2
- nitroguanidine, in or on the following agricultural commodities:
Co mmodity 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 regarding the elements set fo rth in section 408(d)(2) of t he FFDCA; 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 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 residue data have been submitted which adequately support the requested tolerances. B. Toxicological Profile A complete, valid and reliabl e 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 effect level (LOAEL) from the toxicity studies reviewed, are discussed in the Federal Register of May 30, 2003 (68 FR 32390) (FRL
- 7306
-8) [http://www.epa.gov/EPA
- PEST/2003/May/Day
- 30/p13564.htm and in the HED memorandum dated 8/13/2009 from Dr. Michael 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 VegetablesValent U.S.A. Corporation V
- 37696 Page 7 of 117 (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. D ietary exposure (food and water) assessments were conducted by EPA to evaluate the potential risk due to acute and chronic dietary exposure of t he U.S. population and various subgroups to combined residues of clothi anidin and its metabolite TM G plus residues of clothianidin resulting from the use of t hiamethoxam. Residues fro m use of clothianidin on rice grain were not included in the current assessment because the contribution to the overall aggregate exposure is considered negligible since the Experiment Use Permit is restricted to 40,000 acres (1.3 % of the US planting acres), and clothianidin residues are not detectable (<LOD of 5 ppb). Crop residues fo r 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 HED risk assessment memorandum mentioned above (M. Doherty, D355373, D362354, 08/13/2009).

ii. Non
- Dietary Exposure

– residential/recreational turf. N on -dietary exposure to clothianidin fro m residential or recreational (turf grass) application scenarios was assessed using conservative residential adult applicator and post
-application assumption s. iii. Aggregate Assessment of Risks. T he aggregate acute risk assessment includes food, water and residential exposures. B ecause chronic exposure scenarios are not expected from residential uses of clothianidin, 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. C rop residues for rice grain will be included in the aggregate exposure assessment upon the establishment of permanent tolerance to support foliar and seed treatment applications. For acute risk assessment scenarios, the acute population adjusted dose (aPAD) of 0.25 mg/kg was used to assess risks fro m acute dietary exposure to the general population and to various sub
- populations. T he aPAD is based on the NOAEL of 25 mg/kg/day from an acute neurotoxicity study (general population) or a developmental toxicity study (females 13
-49 years of age) with an FQPA safety factor of 1. For chronic risk assessment scenarios, the chronic 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 FQPA safety factor of 1. Based on these risk assessments, the margins of exposure (MOE) fo r all routes of exposure and all population subgroups exceed 100 and therefore do not exceed EPA’s level of concern.Valent U.S.A. Corporation V
- 37696 Page 8 of 117 D . Cumulative Effects. Section 408(b) (2) (D) (v) requires that the Agency must consider available information concerning the cumulative effects of aparticular pesticide's residues and other substances that have a common mechanism of toxicity. Clothianidin is a member of

t he neonicotinoid class of pesticides and is a metabolite of thiamethoxam. Structural similarities or common effects do not constitute a common mechanism of

toxicity and there is currently no evidence that neonicoti noids 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

. T he toxicological database fo r clothianidin is complete. T he ava ilable data indicate that there are no consistent specific target organs in mammals. Based on the completeness of the database and the observed effects, the FQPA Safety Factor has been reduced to 1X, leaving a 100X safety factor to account fo r within
species (10X) and across-species (10X) variability. C lothianidin has been classified as not likely to be carcinogenic to humans. The results of the aggregate exposure risk assessment indicate the MO E’s do not exceed EPA’s level of concern. T here 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 residue limits (MRL) have been establ ished fo r residues of clothianidin at 0.01 milligram/kilogram (mg/kg) in milk, corn, canola, stone fruits, grape, potato and pome fruits. Clothianidin is being evaluated by the JMPR and there are no Codex Maximum Residue Limits (MRL) established.Valent U.S.A. Corporation V
- 37696 Page 9 of 117 Commodity Parts per million Almond, hulls 1.5 Beet, sugar, dried pulp 0.03 Beet, sugar, molasses 0.05 Beet, sugar, roots 0.02 Berry, low
-growing, subgroup 13
- 07H, except strawberry 0.01 Canola, seed 0.01 Cotton, gin byproducts 4.5 Cotton, undelinted seed 0.20 Fig 0.05 Fruit, pome 1.0 Grain, cereal, forage, fodder and straw, group 16, except rice, forage 0.35 Grain, cereal, forage, fodder and straw, group 16, except rice, hay 0.07 Grain, cereal, forage , fodder and straw, group 16, except rice, stover 0.1 Grain, cereal, forage, fodder and straw, group 16, except rice, straw 0.05 Grain, cereal, group 15, except rice 0.01 Grape 0.60 Milk 0.01 Nut, tree, group 14 0.01 Peach 0.80 Pomegranate 0.20 Potato, chips 0.6 Potato, granules/flakes 1.5 Soybean, seed 0.02 Vegetable, brassica, leafy, group 5 1.9 Vegetable, bulb, group 3
-07 0.45 Vegetable, cucurbit, group 9 0.06 Vegetable, fruiting, group 8 0.20 Vegetable, leafy, except brassica, group 4 3.0 Vegetable, root, except sugar beet, subgroup 1B 0.8 Vegetable, tuberous and corm, subgroup 1C 0.3