FILE NAME: Valent. doc (Aug 9 , 2011)

EPA Registration Division contact: Venus Eagle (703
- 308
-8045) **[Insert Petition Number]** amend 40 CFR Summary of Petition EPA has received a pesticide petition (Insert Petition Number) from Interregional Research Project Number 4 (IR
-4), IR
-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W , Princeton, NJ 08450 , 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 1 80.586 (a) , by establishing tolerances fo r 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: Commodity Proposed Tolerance Parts per million (For parent only unless indicated

otherwise) Strawberry 1.4 ppm Citrus Fruit Group ( 10
- 10) 0.5 ppm Citrus Pulp 1 ppm Pistachio 0.01 ppm Tea 50 ppm
EPA has determined that th e 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. Addi tional 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

. . Residue data on strawberry and the represe ntative crops of citrus fruit crop grouping (grapefruit, lemon and orange) has been submitted which adequately support the requested tolerances. Pistachio petition will be supported by the existing tolerance fo r tree nuts ( Crop Group 14 ) of 0.01 ppm. 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. Thenature 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/D ay- 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 fo r Proposed Uses on Berries (Group 13
- 07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetabl es (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) assessments were conducted to evaluate the potential risk due to acute and chronic dietary exposure of the U.S. population and various subgroups to combined residues of clothiani din and its metabolite TMG plus residues of clothianidin resulting from the use of thiamethoxam. Residues were included from the use of clothianidin or thiamethoxam on all existing uses and newly proposed uses including rice, citrus fruits and strawberries. Residues from use of clothianidin on pistachio and tea were not included in the current assessment because the contribution to the overall aggregate exposure is considered negligible. These minor crop residues will be included in the aggregate exposure assessment at a later date.
The Cumulative and Aggregate Risk Evaluation System (CARES) Version 3.0b was used to conduct these assessments using a combination (when available) of actual or generated residue data, experimentally obtained processing factors, and an estimation of percent crop treated. D efault factors or tolerance level residues were used when experimentally determined data were not available. Dietary exposure from drinking water was estimated using a Tier II PRZM/EXAMS assessment to dete rmine the EDWCs in the Standard Index Reservoir associated with clothianidin uses. A 3 0
-year daily concentration time series data set generated from the scenario with the maximum (worst case) EDW S estimates was then imported into CARES Water module in ord er to calculate acute and chronic drinking water and aggregate risks. 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 co nservative residential adult applicator and post
-application assumptions using the CARES Residential Module. iii. Aggregate Assessment of Risks. T he aggregate acute and chronic risk assessment includes food, water and residential exposures. Inclusion of chronic exposure scenarios for residential uses is a very conservative approach since the non -dietary turf related exposure does not represent chronic exposure risk based on the limited annual application rate. 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/dayfrom 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 the acute risk assessment, the maximum aggregate risk from food, water and residential uses is 6% of the aPAD in infants 0 years of age (0 to 1 years). 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

. For the chronic risk assessment, the maximum aggregate risk from food and water is 3.2% of the cPAD in infants 0 years of age (0 to 1 years). Based on these risk assessments, the margins of exposure (MOE) fo r all routes of exposure and all populatio n 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 cumulative effects of aparticular pesticide's res idues 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 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

. T he toxicological database fo r clothianidin is complete. T he available 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, including infants and children, resulting from aggregate exposure to residues of clothianidin

. F. International Tolerances Canadian maximum residue limits (MRL) have been established 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.