Document ID: EPA-HQ-OPP-2008-0771-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-09-27T04:00Z

FILE NAME:  Valent.doc (March, 2018)

EPA Registration Division contact:  RD 

[Insert Petition Number] amend 40 CFR 

Summary of Petition 

EPA has received a pesticide petition (Insert Petition Number) from Valent U.S.A. LLC, 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  adding the import 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 persimmon  with the following:

Commodity
Proposed Tolerance
Parts per million
                 (For parent only unless indicated otherwise)
Persimmon 
                                      0.5

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 import tolerance.

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 persimmon has been submitted to support the requested import tolerance. 
 
                                       

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).  Residues from use of clothianidin on persimmon were not included in the current assessment because the contribution to the overall aggregate exposure is considered negligible 

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 persimmon 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 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) and Codex MRL are stated on the table below. 

Commodity 
Canadian
MRL
Codex
MRL
Almond, hulls
0.1 
--
Beet, sugar, roots
0.1 
0.2
Berry, low-growing, subgroup 13-07H, except strawberry
0.1 
0.07
Canola, seed
0.01
0.02
Cotton, undelinted seed
0.1 
0.02
Fig
0.05
--
Fruit, citrus, group 10-10
0.1 
0.07
Fruit, pome
0.3
0.4
Grain, cereal, forage, fodder and straw, group 16, except rice, straw
--
0.2
Grain, cereal, group 15, except rice
0.1 
0.04
Grape
0.6
0.7
Milk
0.01
0.02
Mustard, seed
0.01
0.02
Nut, tree, group 14
0.1 
--
Peach
0.8
0.2
Pepper
0.2
0.05
Pomegranate
0.2
--
Rice, grain
0.01
0.5
Soybean, seed
0.1 
0.02
Tea, dried
70
0.7
Vegetable, brassica, leafy, group 5
1.9
0.2
Vegetable, bulb, group 3-07
0.45
--
Vegetable, cucurbit, group 9
0.06
0.02
Vegetable, fruiting, group 8, except pepper
0.2
0.05
Vegetable, leafy, except Brassica, group 4
3
2
Vegetable, root, except sugar beet, subgroup 1B
0.8
0.2
Vegetable, tuberous and corm, subgroup 1C
0.3
0.2