Document ID: EPA-HQ-OPP-2010-0217-0043
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-05-06T04:00Z

Valent U.S.A. Corporation		V-37696

Page 6 of 117

FILE NAME:  Valent.doc ( January 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 petition (Insert Petition Number) from  
SEQ CHAPTER \h \r 1 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 180.586 

(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:

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  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 

Valent 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.  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.  

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 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 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