Document ID: EPA-HQ-OPP-2008-0945-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-09T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



  SEQ CHAPTER \h \r 1 								PC Code 	044309

				DP Barcode	D360266

Date                  August 4, 2009 

MEMORANDUM

SUBJECT:	Tier I Estimated Environmental Concentrations of Clothianidin
for the Use in the Human Health Risk Assessment, Registration of Two New
Products for Seed Treatment Containing Multiple Active Ingredients,
Sepresto 75WS and PROCEED™ Optimum, and New Uses for Arena 50WDG,
V-10170 2.13SC, V-1017 5FS, CLUTCH 50WDG and Belay 16WSG

FROM:	José L. Meléndez, Chemist

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)  

THROUGH:	Mah T. Shamim, Branch Chief

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

		

TO:		Kable Davis, Risk Manager Reviewer

		Venus Eagle, Risk Manager #1

		Meredith Laws, Branch Chief

		Insecticide-Rodenticide Branch

		Registration Division (7505P)

AND:		Michael Doherty, Risk Assessor

		Christina Schwartz, Branch Chief

		Registration Action Branch II

		Health Effects Division (7509P)

PROCEED™ Optimum [clothianidin (1.46% a.i.), and prothioconazole,
tebuconazole and methalaxil].  In addition, there are new uses on
tuberous and corm vegetables, bulb vegetables, leafy green vegetables,
brassica (cole) leafy vegetables, fruiting vegetables, cucurbit
vegetables, tree nut, fig, pomegranate, cotton, soybean, peach and low
growing berry (except strawberry) for Arena 50WDG, V-10170 2.13SC,
V-1017 5FS, CLUTCH 50WDG and Belay 16WSG (note, not all uses for all
products).

It was found that turf is still the use with the major exposure, with an
application rate of 0.4 lb a.i./A, and the highest percent crop area
and, therefore, the drinking waters assessment (DWA) results do not
change from the previous ones.  The previous DWA still applies. An
electronic copy of the previous assessment is included (Attachment A).

The EDWCs for clothianidin were calculated based on a maximum
application rate of 0.4 lb a.i./A/season.  The acute drinking water
concentration in surface water is 7.29 ppb of clothianidin, based on
applications of the chemical to turf.  The cancer/chronic surface
drinking water concentration is 1.35 ppb, also based on applications to
turf.  The SCI-GROW generated EDWC is 5.88 ppb of clothianidin, which is
recommended for use, both for acute and chronic exposures.  Table I
provides a summary of the Tier I modeled drinking water concentrations. 
Should there be a need for additional refinements, the EFED can perform
a Tier II aquatic assessment, for surface waters.  For additional
details, refer to Attachment A.

Table 1.  Maximum Tier I Estimated  Drinking Water Concentrations
(EDWCs) (as ug/L or ppb) for drinking water  risk assessment based on
ground application of clothianidin on turf.

Surface water (acute)	Surface water (chronic)	Ground water (acute and
chronic)

FIRST	FIRST	SCI-GROW

7.29	1.35	5.88

Previous assessments

Tier 1 drinking waters assessments were issued on 2/10/03 and 7/6/04,
using FIRST and SCI-GROW.  In the latter assessment, the most
conservative scenario was found to be turfgrass (maximum single and
seasonal application rate 0.4 lb a.i./A).  This is still the use with
the highest seasonal application rate.

Table 2.  Summary of Clothianidin Drinking Water Exposure Assessments

Date	Reference	Uses included	Model(s)1

2/10/2003	DP Barcode: 278110	Canola and corn seed treatment	FIRST (SW)

SCI-GROW (GW)

7/6/2004	DP Barcodes: 299401 and 301729	Turfgrass, Tobacco, Apples,
Pears, and Ornamentals – turf modeled because of highest seasonal
rate.	FIRST (SW)

SCI-GROW (GW)

8/23/2005	DP Barcodes: 313414 and 313415	Foliar uses on potatoes and
grapes, sorghum seed treatment	No new modeling needed

This assessment	DP Barcode 360266	This assessment:  Registration of two
new products for seed treatment containing multiple active ingredients:
Sepresto 75WS and PROCEED™ Optimum.  New uses on tuberous and corm,
bulb, leafy green, brassica (cole) leafy, fruiting and cucurbit
vegetables, and tree nut, fig, pomegranate, cotton, soybean, peach and
low growing berry	No new modeling needed

1 SW =surface water; GW = ground water.

Data Gaps

835.4300 Aerobic Aquatic Metabolism:  The available study (MRID
45422324) was deemed supplemental.  A new study was required in reviews
dated 2/20/03 (D228110) and 9/28/05 (D313414+).  The fate of the
thiazolyl ring needs to be monitored.

835.7100 Small-Scale Prospective Groundwater Monitoring (old guideline
number 166-1):  A study was also required in the reviews dated 2/20/03
and 9/28/05.

Use Characterization

™ Optimum (a proposed new product containing clothianidin and
prothioconazole, tebuconazole and methalaxil).  The use information was
obtained from the proposed labels for Arena 50WDG (EPA Reg. No.
59639-152), V-10170 2.13 SC (EPA Reg. No. 59639-150), V-1017 5FS (EPA
Reg. No. 59639-151), CLUTCH 50 WDG (EPA Reg. No. 59369-152), Belay 16WSG
(EPA Reg. No. 59639-153) and Sepresto 75WS (EPA Reg. No. 264-XXX) and
PROCEED™ Optimum (EPA Reg. No. 264-XXX).

From Table 3 it is noted that of all the uses, turf could involve the
highest exposure, with use rate for a single application at 0.4 lb
a.i./A, applied in granules.  This rate was assessed, using FIRST and
SCI-GROW, in memorandum dated 7/06/04 from L. Liu to D. Kenny and C.
Swartz (Attachment A).  Therefore, a new assessment is not required.

Table 3.  Summary use information for clothianidin, including current
uses (not shaded) and proposed uses (shaded gray) [from proposed labels
for Arena 50WDG (EPA Reg. No. 59639-152), V-10170 2.13 SC (EPA Reg. No.
59639-150), V-1017 5FS (EPA Reg. No. 59639-151), CLUTCH 50 WDG (EPA Reg.
No. 59369-152), Belay 16WSG (EPA Reg. No. 59639-153), Sepresto 75WS3
(EPA Reg. No. 264-XXX) and PROCEED™ Optimum4 (EPA Reg. No. 264-XXX)]. 
The modeled use (turf) appears bolded.

PURPOSE/ SOURCE	USE	oz a.i./         100 lb seed	oz a.i./ 1000 seed	MAX.
IND. APP. RATE (lb. a.i./A)	SEASONAL APP. RATE (lb. a.i./A)	Comments

Sepresto 75WS4	Root & Tuber veg.(CG 1)	NA	0.01575	0.245	0.375	Seed
Treatment

Arena 50WDG, V-10170 2.13SC	Tuberous and corm veg (CSG 1C)	NA	NA	0.05

In furrow 0.2	0.2

	Sepresto 75WS	Potato Seed pieces	0.20	NA	0.25*	NS	Seed Treatment

Arena 50WDG, V-10170 2.13SC, Belay 16WSG	Potato	NA	NA	0.05

In furrow 0.2	0.2

	V-10170 2.13SC	Potato Seed pieces	0.14	NA	0.175*	NS

	V-1017 5FS	Potato Seed pieces	0.12	NA	0.15*	NS	Seed Treatment –
*based on seeding rate of 2000 lb/A (from this label)

Sepresto 75WS	Bulb veg. (CG 3)	NA	0.0071	0.196	0.375	Seed Treatment

Sepresto 75WS	Leafy Greens veg.        (CG 4 or 4A)	NA	0.028	0.0757
0.375	Seed Treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067

Soil-0.2	0.2

	Sepresto 75WS	Brassica (Cole) Leafy veg (CG 5)	NA	0.0416	0.118	0.375
Seed Treatment

Arena 50WDG, V-10170 2.13 SC

NA	NA	Foliar-0.067

Soil-0.2	0.2

	Sepresto 75WS	Fruiting veg. (CG 8)	NA	0.0174	0.0019	0.375	Seed
Treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067

Soil-0.2	0.2

	Sepresto 75WS,	Cucurbit veg. (CG 9)	NA	0.034	0.04610	0.375	Seed
Treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067

PROCEED™ OPTIMUM5	Barley, wheat & triticale	0.11	NA	0.00901	NA	Seed
Treatment

V-10170 5FS	Sorghum	3.1	NA	NS

Seed Treatment

V-10170 5FS	Canola, Rapeseed	4.89	NA	NS

Seed Treatment

V-10170 5FS	Corn (field, pop, seed & sweet corn)	NA	NA	NS

Seed Treatment: 5.64 oz product/ 80,000 seed; 1.25 mg a.i./ kernel

Arena 50WDG, V-10170 2.13SC	Figs	NA	NA	0.0938	0.2

	Arena 50WDG, V-10170 2.13SC	Pomegranates	NA	NA	0.0938	0.2

	Arena 50WDG, V-10170 2.13SC	Cotton	NA	NA	0.067	0.2	Foliar applic.

V-1017 5FS	Soybeans	0.612	NA	0.0211	NS	Seed treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067	0.2

	Arena 50WDG	Peach	NA	NA	0.1	0.2

	Arena 50WDG, V-10170 2.13SC	Cranberry and low growing berry, except
strawberry (CSG 13-07H)	NA	NA	0.066

Soil: 0.2	0.2

	Arena 50WDG, V-10170 2.13SC, Clutch 50WDG	Grapes	NA	NA	0.1

soil 0.2	0.2

	Arena 50WDG, V-10170 2.13SC, Clutch 50WDG	Pome Fruits (various)	NA	NA
0.2	0.2

	Arena 50WDG, V-10170 2.13SC, Belay 16WSG	Tobacco	NA	NA	0.0625

soil 0.2	0.2

	Arena 50WDG, V-10170 2.13SC	Turfgrass	NA	NA	0.4	0.4	Highest individual
& seasonal appln. rate.

Arena 50WDG	Residential apple & pear trees	NA	NA	0.188	0.2	Apply by
ground in 200 gal solution/ A

Arena 50WDG,+ V-10170 2.13SC	Non-bearing fruits & nut trees (in
landscapes not for commercial prod.)	NA	NA	0.2	0.2	+Apply in 200 gal
soln/ A

Arena 50WDG	Containerized Ornamental Plants in Production Greenhouse and
Field Nurseries	NA	NA	NS	0.4	2 oz prod/100 gal water, drench application

Arena 50WDG	Ornamentals in Production Greenhouse and Field Nurseries	NA
NA	NS	0.4	1.26 oz prod/100 gal water, foliar application

V-10170 2.13SC	Ornamentals	NA	NA	NS	0.4	2.4 oz prod/100 gal water,
foliar application

V-10170 2.13SC	Ornamentals grown in flat benches or beds	NA	NA	0.21	0.4
*2.4 oz product/7500 sq ft

Arena 50WDG	In-Ground Plants in Production Greenhouse and Field
Nurseries	NA	NA	NS	0.4	Shrubs-2.4 g per ft of hght; Multi-Trunk Trees
4.8 g/cumulat. inch of trunk diameter at breast hght (soil drench or
soil injection)

Arena 50WDG	Ornamentals in Commercial and Residential Outdoor Landscapes
and Interior Plantscapes	NA	NA	NS	0.4	Foliar (1.26 oz prod/ 100 gal
water)

Soil drench or soil injection - Shrubs-2.4 g per ft of hght; Multi-Trunk
Trees 4.8 g/cumulat. inch of trunk diameter at breast hght

0.4	0.4	Soil applic. for plants grown in beds

CG = Crop Group; CSG = Crop Sub-Group; NA = Not Available; N/A = Not
Applicable; NS = Not Specified; No aerial applications are allowed.

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(. PROCEED™ OPTIMUM is a combination product, containing clothianidin
(1.46% a.i.), and prothioconazole, tebuconazole and methalaxil.

5. Carrots, representative crop, source for approximate seeding rate:  
HYPERLINK "http://pmep.cce.cornell.edu/piap/carrot96/agpractices.html" 
http://pmep.cce.cornell.edu/piap/carrot96/agpractices.html  - and  
HYPERLINK
"http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/carro
t.html" 
http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/carrot
.html  (23000 seeds/oz and 2-2.5 lb seeds/A => 920,000 seeds/A; app rate
for carrots 0.0042 oz/1000 seeds  => 0.24 lb a.i./A)

6. Onions, representative crop, source for approximate seeding rate:  
HYPERLINK "http://www.ag.ndsu.edu/pubs/alt-ag/onions.htm" 
http://www.ag.ndsu.edu/pubs/alt-ag/onions.htm    (8000 seeds/oz and 2-4
lb/A => 512000 seeds/A; app. rate for onions 0.006 oz a.i/1000 seeds. =>
0.19 lb a.i./A)

7. Lettuce, representative crop, source of approximate seeding rate:  
HYPERLINK "http://www.ipmcenters.org/cropprofiles/CP_form.cfm" 
http://www.ipmcenters.org/cropprofiles/CP_form.cfm     (ultimately,
43000 plants/A => 0.075 lb a.i./A)

8.  Same source as above (7).  In CA about 44,000 plants cabbage /A =>
0.11 lb a.i./A

9.  Same source as above (7):  In FL, maximum plant density of tomatoes
is around 4,840/A; for tomatoes, the max. application rate is 0.00348 oz
a.i./1000 seed => 0.001 lb a.i./A (note, transplants are not considered)

10.  Same source as above (7), in FL, cucumbers maximum plant population
is 21,780/A => 0.046 lb a.i./A

11.    HYPERLINK "http://www.ces.purdue.edu/extmedia/AY/AY-217-W.pdf" 
http://www.ces.purdue.edu/extmedia/AY/AY-217-W.pdf   Max seeding rate
210,025 seeds/A;   HYPERLINK
"http://www.ipm.iastate.edu/ipm/icm/1998/10-12-1998/lowersoycost.html" 
http://www.ipm.iastate.edu/ipm/icm/1998/10-12-1998/lowersoycost.html   
2000-4000 seeds/lb

 Environmental chemistry methods used to generate data associated with
this study must include results of a successful confirmatory method
trial (validation) by an independent laboratory. Agency approval of a
protocol is necessary prior to initiation of the study.

	

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