Document ID: EPA-HQ-OPP-2011-0860-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-12-08T05:00Z

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   SEQ CHAPTER \h \r 1  ,
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  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)

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 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.  .

 Residue data on strawberry and the representative 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 for 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. 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 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 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.  Default
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 determine the EDWCs in the Standard Index
Reservoir associated with clothianidin uses.  A 30-year daily
concentration time series data set generated from the scenario with the
maximum (worst case) EDWS estimates was then imported into CARES Water
module in order to calculate acute and chronic drinking water and
aggregate risks.

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 using the CARES Residential
Module.  

iii. Aggregate Assessment of Risks.  The 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 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 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) 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, including infants and children, 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.