Document ID: EPA-HQ-OPP-2008-0271-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-07-14T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION  AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		May 26, 2009

Subject:		Indoxacarb.  ADDENDUM to the Health Effects Division (HED)
Human Health Risk Assessment for Bushberry Crop Subgroup 13-07B and
Beets (Garden).   

PC Code:  067710	DP Barcode No.: D365306

Decision No.: 390597	Registration No.: 352-597

Petition No.:  8E7324	Regulatory Action: Amended Section 3 Registration

Risk Assessment Type: Single Chemical /Aggregate	Case No.: NA

TXR No.:  NA	CAS No.: 173584-44-6

MRID No.:  NA	40 CFR:  180.564

		              									

	From:	Danette Drew, Chemist

		Seyed Tadayon, Chemist

		Risk Assessment Branch V

		Health Effects Division (7509P)

	         

	Through:	Jack Arthur, Acting Branch Chief

		Risk Assessment Branch V

		Health Effects Division (7509P)

		

	To:	Barbara Madden, RM Team5

		Susan Stanton, RM Team5

		Risk Integration, Minor Use & Emergency Response Branch

		Registration Division (7505P)

This document serves as an addendum to the Health Effects Division (HED)
Human Health Risk Assessment for Bushberry Crop Subgroup 13-07B and
Beets (Garden) for indoxacarb (dated 5/18/09, D351087). This addendum
revises the refined chronic dietary assessment (Memo, S. Tadayon,
5/13/09, D364939) and the residue and exposure values presented here
supersede those found in the 5/13/09 document. Specifically, the 5/13/09
dietary assessment included the available USDA PDP monitoring data for
indoxacarb on grapes for the year 2005. Since indoxacarb was not
registered for use on grapes until 2007, the 2005 grape monitoring data
are not appropriate for use in risk assessment. The chronic assessment
was revised to incorporate field trial residues for grape commodities
(average value of 0.503 ppm) and 100% crop treated. All other input
parameters are as outlined in the 5/13/09 memo.

Additionally, aggregate risk estimates are updated herein to include the
revised chronic dietary exposures and supersede those estimates found in
the 5/18/09 risk assessment. The risk conclusions are unchanged from the
5/18/09 assessment: Chronic dietary (food + water) risk estimates are
below HED’s level of concern for indoxacarb. Aggregate (food + water +
residential) risk estimates are also below the level of concern.

Chronic Dietary Exposure Results

Estimated chronic dietary risk to indoxacarb from food and drinking
water is below HED’s level of concern (%cPAD <100).  Combined dietary
exposure from food and drinking water is estimated at 0.001316 mg/kg/day
(6.6 % of the cPAD) for children, 1 to 2 years old, the population
subgroup with the highest estimated chronic dietary exposure to
indoxacarb.

Table 1:	Summary of Chronic Dietary Exposure and Risk for Indoxacarb
(Drinking Water Exposure Included).

Population Subgroup	cPAD (mg/kg/day)*	Chronic

Exposure (mg/kg/day)	

%cPAD

General U.S. Population	0.02	0.000666	3.3

All Infants (< 1 year old)

0.000607	3.0

Children 1-2 years old

0.001316	6.6

Children 3-5 years old

0.001160	5.8

Children 6-12 years old

0.000623	3.1

Youth 13-19 years old

0.000488	2.4

Adults 20-49 years old

0.000550	2.7

Adults 50+ years old

0.000791	4.0

Females 13-49 years old

0.000571	2.9

*toxicological doses used here reflect KN128 + KN127, not adjusted for
100%KN128, since analytical methods detect combined enantiomer residues.

The population subgroup with the highest estimated exposure/risk is
bolded

Aggregate Risk (food + drinking water + residential exposure)

Indoxacarb aggregate (food + water + residential) risk estimates are not
 of concern for children or adults when assessing the Advion 0.045%G,
Advion 0.22%G, or Provaunt 1.25SC turf scenarios (aggregate MOEs>100). 

Advion 0.045%G

Table 2.  Short/Intermediate-Term Aggregate Risk Calculations for
Toddlers:  Advion 0.045%G

Population	Target

MOE	Chronic Food + Water	Residential Oral	Residential Dermal	Aggregate
MOE6

(food + water + residential)

Exposure

(mg/kg/day)	MOE1	Exposure2

(mg/kg/day)	MOE3	Exposure4

(mg/kg/day)	MOE5

	Children (1-2 years old)	100	0.001316	1500	0.00001	150,000	0.00026
150,000	1500

1   MOE = NOAEL (2.0 mg/kg/day; KN127+ KN128)) ÷ (chronic food + water
exposure)

2   Residential oral = hand-to-mouth from contacting treated turf, the
highest oral exposure scenario (ingestion of treated soil and mouthing
grass exposures are not significant exposure contributors compared to
hand-to-mouth activities)

3   MOE = NOAEL (1.5 mg/kg/day; KN128) ÷ (sum of residential oral
exposure)

4   Residential dermal = post-application turf contact5   MOE = NOAEL
(38 mg/kg/day; KN128) ÷ (residential dermal exposure)

6   Aggregate MOE = 1/[(1/1500) + (1/150,000) + (1/150,000)]

Table 3.  Short/Intermediate-Term Aggregate Risk Calculations for
Adults:  Advion 0.045%G

Population1	Target

MOE	Chronic Food + Water	Residential Dermal	Aggregate MOE5

(food + water + residential)

Exposure

(mg/kg/day)	MOE2	Exposure3

(mg/kg/day)	MOE4

	U.S. Population	100	0.00666	3000	0.000156	240,000	3000

1   Adult population with highest chronic food and water exposure value
was used.

2   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (chronic food + water
exposure)

3   Residential dermal = post-application exposure; application exposure
not a significant contributor compared to post-application.

4   MOE = NOAEL (38 mg/kg/day; KN128) ÷ (residential dermal exposure)

5   Aggregate MOE = 1/[(1/3000) + (1/240,000)]

Advion 0.22%G

Table 4.  Short/Intermediate-Term Aggregate Risk Calculations for
Toddlers:  Advion 0.22%G

Population	Target

MOE	Chronic Food + Water	Residential Oral	Residential Dermal	Aggregate
MOE6

(food + water + residential)

Exposure

(mg/kg/day)	MOE1	Exposure2

(mg/kg/day)	MOE3	Exposure4

(mg/kg/day)	MOE5

	Children (1-2 years old)	100	0.001316	1500	0.0088	230	0.239	210	102

1   MOE = NOAEL (2.0 mg/kg/day; KN127+ KN128)) ÷ (chronic food + water
exposure)

2   Residential oral = hand-to-mouth from contacting treated turf, the
highest oral exposure scenario (ingestion of treated soil and mouthing
grass exposures are not significant exposure contributors compared to
hand-to-mouth activities)

3   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (sum of residential oral
exposure)

4   Residential dermal = post-application turf contact5   MOE = NOAEL
(50 mg/kg/day;KN127+ KN128) ÷ (residential dermal exposure)6  
Aggregate MOE = 1/[(1/1500) + (1/230) + (1/210)]

Table 5.  Short/Intermediate-Term Aggregate Risk Calculations for
Adults: Advion 0.22%G

Population1	Target

MOE	Chronic Food + Water	Residential Dermal	Aggregate MOE5

(food + water + residential)

Exposure

(mg/kg/day)	MOE2	Exposure3

(mg/kg/day)	MOE4

	U.S. Population	100	0.000666	3000	0.137	360	320

1   Adult population with highest chronic food and water exposure value
was used.

2   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (chronic food + water
exposure)

3   Residential dermal = post-application; application exposure not a
significant contributor compared to post-application.

4   MOE = NOAEL (50 mg/kg/day; KN127+KN128) ÷ (residential dermal
exposure)

5   Aggregate MOE = 1/[(1/3000) + (1/360)]

Provaunt 1.25%SC

Table 6.  Short/Intermediate-Term Aggregate Risk Calculations for
Toddlers:  Provaunt 1.25%SC

Population	Target

MOE	Chronic Food + Water	Residential Oral	Residential Dermal	Aggregate
MOE6

(food + water + residential)

Exposure

(mg/kg/day)	MOE1	Exposure2

(mg/kg/day)	MOE3	Exposure4

(mg/kg/day)	MOE5

	Children (1-2 years old)	100	0.001316	1500	0.0044	460	0.022	2300	310

1   MOE = NOAEL (2.0 mg/kg/day; KN127+ KN128)) ÷ (chronic food + water
exposure)

2   Residential oral = hand-to-mouth from contacting treated turf, the
highest oral exposure scenario (ingestion of treated soil and mouthing
grass exposures are not significant exposure contributors compared to
hand-to-mouth activities)

3   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (sum of residential oral
exposure)

4   Residential dermal = post-application turf contact

5   MOE = NOAEL (50 mg/kg/day;KN127+ KN128) ÷ (residential dermal
exposure)

6   Aggregate MOE = 1/[(1/1500) + (1/460) + (1/2300)]

Table 7.  Short/Intermediate-Term Aggregate Risk Calculations for
Adults: Provaunt 1.25%SC

Population1	Target

MOE	Chronic Food + Water	Residential Dermal	Aggregate MOE5

(food + water + residential)

Exposure

(mg/kg/day)	MOE2	Exposure3

(mg/kg/day)	MOE4

	U.S. Population	100	0.000666	3000	0.013	3800	1700

1   Adult population with highest chronic food and water exposure value
was used.

2   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (chronic food + water
exposure)

3   Residential dermal = post-application; application exposure not a
significant contributor compared to post-application.

4   MOE = NOAEL (50 mg/kg/day; KN127+KN128) ÷ (residential dermal
exposure)

5   Aggregate MOE = 1/[(13000) + (1/3800)]

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