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

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

[Insert Petition Number] 

Summary of Petition 

EPA has received a pesticide petition (Insert 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 amend 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-nitroguanidine, 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 regarding 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 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 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 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 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) assessments were conducted by 

EPA to evaluate the potential risk due to acute and chronic dietary exposure of the U.S. 

population and various subgroups to combined residues of clothianidin and its metabolite 

TMG plus residues of clothianidin resulting 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 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 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 HED risk assessment memorandum mentioned 

above (M. Doherty, D355373, D362354, 08/13/2009). 

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

clothianidin from residential or recreational (turf grass) application scenarios was 

assessed using conservative residential adult applicator and post-application assumptions. 

iii. Aggregate Assessment of Risks. The aggregate acute risk assessment includes food, 

water and residential exposures. Because 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. Crop 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 from acute dietary exposure to the general population and 

to various sub-populations. The 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) 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 cumulative effects of a particular pesticide's 

residues and other substances that have a common mechanism of toxicity. Clothianidin is 

a member of the 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. The toxicological database for clothianidin is complete. The 

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 for within-species 

(10X) and across-species (10X) variability. Clothianidin 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 residue limits (MRL) have been 

established for residues of clothianidin at 0.01 milligram/kilogram (mg/kg) in milk, corn, 

canola, stone fruits, grape, potato and pome fruits. Clothianidin has not been evaluated by 

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