FILE NAME: Valent.doc (August 6, 2012)

EPA Registration Division contact: Marianne Lewis (703-308-8043)

[Insert Petition Number] amend 40 CFR 

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 , 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 deleting the tolerances for residues of the 

insecticide chemical clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-

nitroguanidine, in or on the vegetable, fruiting , group 8 and fruit, pome and establishing 

the tolerances 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:

Commodity

Proposed Tolerance

Parts per million

(For parent only unless indicated 

otherwise)

Vegetables, fruiting , group (08-10) 0.2

Fruit , pome, group (11-10) 1.0

Rice, grains 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. No additional residue data is needed to support the updated 

crop groupings of vegetables, fruiting , group (08-10) and fruit , pome, group (11-10) 

since the proposed tolerance levels remain the same as the established tolerances for 

vegetable, fruiting , group 8 and fruit, pome. A rational along wit residue data have 

been submitted which adequately support the requested tolerances for rice grains.

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. . 

Details of the model parameters can be found in the HED risk assessment memorandum 

mentioned above (M. Doherty, D355373, D362354, 08/13/2009). No additional dietary 

exposure is anticipated since the proposed tolerance levels for the updated crop 

groupings of vegetables, fruiting , group (08-10) and fruit , pome, group (11-10) remain 

the same as the established tolerances for vegetable, fruiting , group 8 and fruit, pome. . 

Residues from the use of clothianidin on rice were not included in the current 

assessment because the contribution to the overall aggregate exposure is considered 

negligible. The residues in rice grains are less than, LOQ (Limit of Quantitation) of 0.01 

ppm. 

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. No additional exposure is anticipated since the 

proposed tolerance levels for the updated crop groupings of vegetables, fruiting , group 

(08-10) and fruit , pome, group (11-10) remain the same as the established tolerances 

for vegetable, fruiting , group 8 and fruit, pome. Residues from use of clothianidin on 

rice were not included in the current assessment because the contribution to the overall 

aggregate exposure is considered negligible. 

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 withinspecies (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 is being evaluated by the 

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