Document ID: EPA-HQ-OPP-2009-0289-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-02-12T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES

									AND TOXIC SUBSTANCES

Jan 14, 2010

MEMORANDUM

SUBJECT:	Acetamiprid: Revised Human Health Risk Assessment for Proposed
Food Uses on Clover Grown for Seed, Small Vine Climbing Fruits, except
Fuzzy Kiwifruit, Subgroup 13-07F, Greenhouse Grown Tomatoes and Tea.  

PC Code:  099050	DP Barcode:  D372626

Decision No.:  408298	Registration Nos.:  8033-23,  8033-36, 8033-94

Petition No.:  9E7544	Regulatory Action:  Amended Section 3

Risk Assessment Type:  Single Chemical Aggregate	Case No.:  N/A

TXR No.:  N/A	CAS No.:  135410-20-7

MRID Nos.:  N/A	40 CFR:  §180.578

FROM:	Dennis McNeilly, Chemist

		Registration Action Branch 2

Health Effects Division (7509P)

THROUGH:	Christina Swartz, Branch Chief

	Richard Loranger, Ph.D., Senior Scientist

Registration Action Branch 2

Health Effects Division (7509P)

TO:			Laura Nollen, Risk Manager Reviewer

			Barbara Madden, Team Leader (RM Team 5)

			RIMUERB/Registration Division (RD) (7505P)



Table of Contents

  TOC \f \h    HYPERLINK \l "_Toc250621793"  1.0  Executive Summary	 
PAGEREF _Toc250621793 \h  3  

  HYPERLINK \l "_Toc250621794"  2.0	Summary of Toxicological Doses and
Endpoints for Use in Human Risk Assessments	  PAGEREF _Toc250621794 \h 
5  

  HYPERLINK \l "_Toc250621795"  3.0	Dietary Exposure/Risk
Characterization	  PAGEREF _Toc250621795 \h  6  

  HYPERLINK \l "_Toc250621796"  4.0	Residential (Non-Occupational)
Exposure/Risk Characterization	  PAGEREF _Toc250621796 \h  9  

  HYPERLINK \l "_Toc250621797"  4.1	Residential Handler Exposure	 
PAGEREF _Toc250621797 \h  10  

  HYPERLINK \l "_Toc250621798"  4.2.	Residential Postapplication
Exposure	  PAGEREF _Toc250621798 \h  10  

  HYPERLINK \l "_Toc250621799"  5.0	Aggregate Risk Assessments and Risk
Characterization	  PAGEREF _Toc250621799 \h  12  

  HYPERLINK \l "_Toc250621800"  5.1	Acute Term Aggregate Risk	  PAGEREF
_Toc250621800 \h  12  

  HYPERLINK \l "_Toc250621801"  5.2	Short- and Intermediate-Term
Aggregate Risk	  PAGEREF _Toc250621801 \h  12  

  HYPERLINK \l "_Toc250621802"  5.3	Chronic-Term Aggregate Risk	 
PAGEREF _Toc250621802 \h  13  

  HYPERLINK \l "_Toc250621803"  6.0	Data Needs and Label Recommendations
  PAGEREF _Toc250621803 \h  13  

  HYPERLINK \l "_Toc250621804"  References:	  PAGEREF _Toc250621804 \h 
13  

 

1.0	Executive Summary  TC \l1 "1.0  Executive Summary 

This memorandum serves to revise HED’s human health risk assessment
for acetamiprid (D. McNeilly, D369474, 12/1/09).  RD has requested that
HED redo the dietary exposure analyses using 100% percent crop treated
for amended use patterns, i.e., grapes and other crop subgroup 13-07F
commodities, and tomatoes.  This memorandum revaluates the acute and
chronic dietary risk and exposures, and updates the aggregate exposure
and risk based on the revised chronic dietary exposure assessment.

The dietary assessment is partially refined, using field trial data,
percent crop-treated values, and various empirical processing factors. 
Estimated drinking water concentrations (EDWCs), which are based upon
the highest application values of all registered and proposed uses, have
been incorporated directly into the dietary exposure model.  Acute and
chronic dietary risk estimates for all population subgroups do not
indicate a risk of concern.  Acute dietary exposure estimates at the
99.9th percentile are below HED’s level of concern for the general
U.S. population and all other population subgroups.  For the U.S.
population, the estimated exposure of 0.024 mg/kg/day corresponds to 24%
aPAD; for children 1-2 years old, the estimated exposure of 0.043
mg/kg/day corresponds to an acute dietary risk of 43% aPAD.  Chronic
dietary exposure to acetamiprid, including existing and proposed uses,
is below HED’s level of concern for the U.S. population and all other
population subgroups.  For the general US population, an estimated
exposure of 0.0028 mg/kg/day corresponds to 4% of the chronic population
adjusted dose (cPAD); children 1-2 years old were the highest exposed
population subgroup, with an estimate of 0.010 mg/kg/day, or 15% cPAD. 
Risks for all population subgroups are less than 100% cPAD, and are not
of concern.

Aggregate risk assessments for acute, short-term, and chronic durations
were conducted.  Residential exposures incorporated into the aggregate
assessments are based on currently registered residential uses (indoor
crack and crevice, and outdoor perimeter treatment).  All aggregate
assessments indicate no risks of concern (aggregate MOEs ≥ 270).

Environmental Justice Considerations

Potential areas of environmental justice concerns, to the extent
possible, were considered for this human health risk assessment, in
accordance with US Executive Order 12898, Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations,   HYPERLINK
"http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf" 
http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf .

As a part of every pesticide risk assessment, OPP considers a large
variety of consumer subgroups according to well-established procedures. 
In line with OPP policy, HED estimates risks to population subgroups
from pesticide exposures that are based on patterns of that subgroup’s
food and water consumption, and activities in and around the home that
involve pesticide use in a residential setting.  Extensive data on food
consumption patterns are compiled by USDA under the CSFII, and are used
in pesticide risk assessments for all registered food uses of a
pesticide.  These data are analyzed and categorized by subgroups based
on age, season of the year, ethnic group, and region of the country. 
Whenever appropriate, non-dietary exposures based on home use of
pesticide products, associated risks for adult applicators and for
toddlers, youths, and adults entering or playing on treated areas
post-application are evaluated.  Further considerations are currently in
development as OPP has committed resources and expertise to the
development of specialized software and models that consider exposure to
bystanders and farm workers as well as lifestyle and traditional dietary
patterns among specific subgroups.

Review of Human Research

This risk assessment relies in part on data from studies in which adult
human subjects were intentionally exposed to a pesticide or other
chemical.  These studies, which comprise the Pesticide Handlers Exposure
Database (PHED), have been determined to require a review of their
ethical conduct, and have received that review. The studies in PHED were
considered appropriate (or ethically conducted) for use in risk
assessments.

2.0	Summary of Toxicological Doses and Endpoints for Use in Human Risk
Assessments  TC \l1 "2.0	Summary of Toxicological Doses and Endpoints
for Use in Human Risk Assessments 

The following table was labeled as table 3.5.11 in HED’s Dec 1, 2009
review (D369474, D. McNeilly).  It is included here to confirm that
end-points have not changed since that recent review and also for easy
reference.

Table 3.5.11a.   Summary of Toxicological Doses and Endpoints of
Acetamiprid for Use in Dietary and Non-Occupational Human Health Risk
Assessment

Exposure Scenario	Dose Used in Risk Assessment	Uncertainty Factors/FQPA
Safety Factors	RfD, PAD Level of Concern for Risk Assessment	Study and
Toxicological Effect

Acute Dietary (All populations)

	NOAEL = 10 mg/kg/day	UFA = 10x

UFH = 10x

FQPA SF = 1x

	aPAD = 0.10 mg/kg/day	Developmental Neurotoxicity in rat

LOAEL = 45 mg/kg/day based on decreased body weight and body weight
gains in offspring, decreased early pup survival on PND 0-1, and
decreased startle response on PND 20/60 in males.

Acute Neurotoxicity Study in rat

LOAEL = 30 mg/kg/day based on decreased locomotor activity

Chronic Dietary

all populations	NOAEL = 7.1 mg/kg/day	UFA = 10x

UFH = 10x

FQPA SF = 1x

	cPAD = 0.071 mg/kg/day	Chronic Toxicity/Oncogenicity Study in rats

LOAEL = 17.5 mg/kg/day based on decreased body weight and body weight
gains in females and hepatocellular vacuolation in males.

Short- and Intermediate-Term Incidental Oral 

(1-30 days and 1-6 mo.)

	NOAEL = 10 mg/kg/day	UFA = 10x

UFH = 10x

FQPA SF = 1x

	LOC for MOE = 100

	Developmental Neurotoxicity in rat

LOAEL = 45 mg/kg/day based on decreased body weight and body weight
gains in offspring, decreased early pup survival on PND 0-1, and
decreased startle response on PND 20/60 in males.

Short- and Intermediate-term Dermal

(1-30 days, 1–6 mo.)

	NOAEL = 10 mg/kg/day

DAF = 10%	UFA = 10x

UFH = 10x

FQPA SF = 1x

	LOC for MOE = 100

	Developmental Neurotoxicity in rat

LOAEL = 45 mg/kg/day based on decreased body weight and body weight
gains in offspring, decreased early pup survival on PND 0-1, and
decreased startle response on PND 20/60 in males.

Short- and Intermediate-term Inhalation

(1-30 days, 1–6 mo.)

	NOAEL = 10 mg/kg/day

IAF = 100%	UFA = 10x

UFH = 10x

FQPA SF = 1x

	LOC for MOE = 100

	Developmental Neurotoxicity in rat

LOAEL = 45 mg/kg/day based on decreased body weight and body weight
gains in offspring, decreased early pup survival on PND 0-1, and
decreased startle response on PND 20/60 in males.

Cancer (oral, dermal, inhalation) - not likely to be carcinogenic to
humans.

DAF = dermal absorption factor.  Point of Departure (POD) = A data point
or an estimated point that is derived from observed dose-response data
and  used to mark the beginning of extrapolation to determine risk
associated with lower environmentally relevant human exposures.  NOAEL =
no observed adverse effect level.  LOAEL = lowest observed adverse
effect level.  UF = uncertainty factor.  UFA = extrapolation from animal
to human (interspecies).  UFH = potential variation in sensitivity among
members of the human population (intraspecies).  FQPA SF = FQPA Safety
Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD =
reference dose.  MOE = margin of exposure.  LOC = level of concern.  N/A
= not applicable.3.0	Dietary Exposure/Risk Characterization  TC \l1
"3.0	Dietary Exposure/Risk Characterization 

Acute and chronic dietary risk assessments were conducted for
acetamiprid using the Dietary Exposure Evaluation Model (DEEM-FCID(,
Version 2.03) which uses food consumption data from the USDA’s
Continuing Surveys of Food Intakes by Individuals (CSFII, 1994-1996 and
1998).  The acute and chronic dietary analyses are considered partially
refined by the inclusion of percent crop treated values and processing
data.  The full dietary analysis for the subject petition can be found
in the HED memorandum:  Acetamiprid.  Revised Acute and Chronic Dietary
Exposure Assessments to Support Section 3 Registration of Uses on
Clover, Small Vine Climbing Fruits, except Kiwifruit, Subgroup 13-07F,
Greenhouse Grown Tomatoes and Tea.  D372890, 1/14/10, D. McNeilly.

The current acute and chronic dietary exposure assessments include
existing uses and the tolerances proposed by the Interregional Research
Project Number 4 (IR-4) for new uses of acetamiprid on clover grown for
seed, small vine climbing fruits, except kiwifruit, subgroup 13-07F
(amending established grape uses), greenhouse-grown tomatoes, and tea.

the DEEM™ Version 7.87 default processing factors were used.  Those
default factors were used for all processed commodities in the chronic
assessment except for grape juice, and raisins (dried prunes and tomato
paste have separate tolerances).  Finally, tolerance level residues were
also used for livestock commodities.

Usage Data

In order to refine the dietary exposure estimates for acetamiprid, HED
requested a Screening Level Usage Analysis (SLUA), which was conducted
by the Biological and Economic Analysis Division (BEAD), 6/11/09.  The
SLUA includes estimates of maximum %CT for the acute assessment and
average %CT for determining chronic exposure (Table 3.0).  Commodities
with the most significant acetamiprid usage in terms of maximum %CT
include pears (60%), apples (30%), celery (45%), and lettuce (20%). 
Commodities with the most significant usage in terms of lbs ai applied
include apples (10,000), cotton (20,000), and pears (5,000).

Table 3.0.   Percent Crop Treated Data Used in DEEM

Commodity	Avg	Max

Apples	20	30

Broccoli	5	15

Cabbage	5	10

Cauliflower	10	15

Celery	25	45

Cotton	5	5

Grapefruit	2.5	51

Lemons	5	100

Lettuce	10	20

Oranges	2.5	5

Peaches	1	2.5

Pears	35	60

Peppers	2.5	5

Potatoes	2.5	2.5

Pumpkins	1	2.5

Spinach	5	15

Squash	2.5	2.5

1  -  The residue distribution file for oranges which used 5% CT was
also used for grapefruit.  This was higher than the 2.5% CT for
grapefruit estimated by BEAD and is more conservative.

For the acute analysis, %CT was incorporated into RDFs.  For the chronic
analysis, average %CT was included for the commodities listed in the
table above.  

3.1	Exposure and Risk Characterization

The dietary analyses reflect all currently registered and proposed
acetamiprid uses and indicate that both the acute and chronic dietary
exposure do not present a risk concern for HED for the general U.S.
population or any of population subgroup (Table 3.1).

HED incorporated EDWCs directly into the DEEM™ FCID model for
“water, direct, all sources” and “water, indirect, all sources.”
 For the acute assessment, an EDWC of 20.1 ppb was entered into the
model, and for the chronic assessment, the value of 4.9 ppb was used.

Acute Dietary (Food and Drinking Water) Exposure Results and
Characterization

The probabilistic acute dietary exposure assessment included anticipated
residues from field residue trials, processing factors, maximum %CT
estimates (for existing uses only) generated by the Biological and
Economic Analysis Division (BEAD), and the modeled peak concentration of
acetamiprid residues in surface water sources of drinking water.  100
%CT was assumed for grapes, tomatoes, and crops where % crop treated
information was not available.  Although the acute assessment has been
refined, the resulting exposure estimates are still considered
conservative since field trial data were the basis for the anticipated
residues, and because a lower tier drinking water model (FIRST) was used
to estimate residues in drinking water.

Acute dietary exposure estimates at the 99.9th percentile are below
HED’s level of concern for the general US population and all other
population subgroups.  For the US population, the estimated exposure of
0.024 mg/kg/day corresponds to 24% aPAD; for children 1-2 years old, the
estimated exposure of 0.043 mg/kg/day corresponds to an acute dietary
risk of 43% aPAD.

Chronic Dietary (Food and Drinking Water) Exposure Results and
Characterization

For the chronic analysis, tolerance-level residues were assumed for all
food commodities with existing and proposed acetamiprid tolerances. 
Percent crop treated was used for many commodities as detailed in Table
3.0.  The chronic analysis also included the modeled surface water
annual average residue in drinking water.  Even though %CT information
was used in the chronic analysis, the exposure and risk estimates are
still conservative since tolerance level residues were used, because 100
%CT was assumed for crops where % crop treated information was not
available, and because a lower tier drinking water model (FIRST) was
used.

Chronic dietary exposure to acetamiprid, including existing and proposed
uses, is below HED’s level of concern for the U.S. population and all
other population subgroups.  For the general U.S. population, and
estimated exposure of 0.0028 mg/kg/day corresponds to 4% of the chronic
population adjusted dose (cPAD); children 1-2 years old were the highest
exposed population subgroup, with an estimate of 0.010 mg/kg/day, or 15
% cPAD.  Risks for all population subgroups are less than 100 % cPAD,
and are not of concern.



Table 3.1.  Summary of Dietary (Food + Water) Exposure and Risk for
Acetamiprid

Population Subgroup	Acute Dietary

(99.9th Percentile)	Chronic Dietary

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.023768	24	0.002835	4.0

All Infants (< 1 year old)	0.031227	31	0.005206	7.3

Children 1-2 years old	0.042928	43	0.010358	15

Children 3-5 years old	0.034282	34	0.007296	10

Children 6-12 years old	0.024123	24	0.004055	5.7

Youth 13-19 years old	0.017682	18	0.002170	3.1

Adults 20-49 years old	0.015543	16	0.002031	2.9

Adults 50+ years old	0.013291	13	0.002130	3.0

Females 13-49 years old	0.013133	13	0.002057	2.9

3.2	Cancer Dietary Risk

HED has classified acetamiprid as “not likely to be carcinogenic to
humans.”  Based upon this classification, HED has determined there is
no cancer risk associated with the existing and proposed uses. 

4.0	Residential (Non-Occupational) Exposure/Risk Characterization  TC
\l1 "4.0	Residential (Non-Occupational) Exposure/Risk Characterization 

The registrant has not proposed new or revised residential uses. 
Therefore, new residential handler and postapplication exposure
assessments were not conducted.   Acetamiprid is registered for
controlling a wide variety of indoor and outdoor insect pests in
residential settings.  The MOEs for residents applying bait and gel
products were 1500-3500 (D303171, T. Moriarty, 10/25/07).  In a more
recent assessment of exposures to residential handlers from products
used on indoor and outdoor residential settings, the risks were found to
be not of concern for all scenarios identified (D353040, Z. Figueroa,
12/1/08).  An analysis of the postapplication risks to adults and
children from contacting treated areas has also been performed recently
(D353012, C. Swartz, 12/12/08).  In the tables below, only the risk to
children are shown since as noted in the 12/12/08 memo they are the
worse case versus those for adults.



Table 4a.  Acetamiprid: Short- and Intermediate-Term Postapplication
Exposures and Risks to Toddlers Following

                                                          Turf
Treatments in Residential Settings.1 

Exposure Scenario	Application Rate

(lb AI/acre)	Exposure  (mg/kg/day)	MOE 2

Short-term	Interm. term	Short-term	Interm. term

Residential turf  (dermal) 	0.187	0.0072	0.0036	1,400	2,800

Hand to mouth (oral) 

0.0028	0.0013	3,600	7,600

Object to mouth (oral)  

0.00069	NA	14,500	NA

Incidental soil ingestion (oral)

0.0000093	NA	1,100,000	NA

Total exposure  (dermal & oral)	N/A	0.0107	0.0049	900	2,000

1.  From C. Swartz, D353012, 12/12/08.

2.  Short- & intermediate-term dermal or oral NOAEL (10
mg/kg/day)/exposure (mg/kg/day).

TABLE 4b:  Acetamiprid: Short-term Postapplication Exposure and Risk to
Toddlers Following Indoor Crack 

                                                                        
  and Crevice Treatments 1

Exposure Scenario	Descriptor	Exposure (mg/kg/day)	MOE 2

Dermal exposure	Carpet and hard surfaces	0.0195	510

Incidental oral exposure

0.0065	1500

Total dermal & oral exposures 

0.026	380

1. From C. Swartz, D353012, 12/12/08.

2.  Short- & intermediate-term dermal or oral NOAEL (10
mg/kg/day)/exposure (mg/kg/day).

Aggregate exposures of acetamiprid include the short- and
intermediate-term postapplication exposures following turf treatment and
the short-term postapplication exposure following indoor crack and
crevice treatment.

4.1	Residential Handler Exposure TC \l2 "4.1	Residential Handler
Exposure 

The MOEs for residents applying bait and gel products were 1500-3500
(D303171, T. Moriarty, 10/25/07).  In a recent assessment of exposures
to residential handlers from products used on indoor and outdoor
residential settings, the risks are not of concern for all applicable
scenarios identified (D353040, Z. Figueroa, 12/1/08).

4.2.	Residential Postapplication Exposure TC \l2 "4.2.	Residential
Postapplication Exposure 

An evaluation of postapplication exposure resulting from the proposed
use and label change was completed (D353040, Z. Figueroa, 12/1/08 and
D366701, S. Oonnithan, 10/9/09); risks were not of concern for any of
the scenarios identified and assessed.  Detailed discussions of the
assumptions and methods used for assessing residential exposure from the
proposed use are provided in the 12/1/08 memorandum.

The postapplication scenarios assessed for toddlers’ exposure
following perimeter treatment include:

Dermal exposure from treated lawns due to high contact lawn activities; 

Hand-to-mouth transfer of pesticide residues on lawns; 

Object-to-mouth transfer of pesticide residues on lawns; and 

Incidental ingestion of soil from pesticide-treated residential areas.

Risks for these scenarios are provided in Table 4.2a.

Table 4.2a. Short- and Intermediate-Term Dermal & Indirect Ingestion -
Toddler Residential Risk Estimates for Postapplication Exposure on Turf

Exposure Scenario	Route of Exposure	Application Rate

(lb ai/acre)	Dermal Transfer Coefficient (µg/cm2)	Absorbed Dose
(mg/kg/day)	MOE

Residential Turf 	Dermal	0.187	5,200

(Short-term)	0.0072

(Short-term)	1,400

	2,600

(Intermediate-term)	0.0036

(Intermediate-term)	2,800

Hand to Mouth	Oral

NA	0.0028

(Short-term)	3,600

0.0013

(Intermediate-term)	7,600

Object to Mouth 	Oral

NA	0.00069	14,500

Incidental Soil Ingestion	Oral

NA	0.0000093	1,100,000

Combined Exposure1	N/A	N/A	N/A	0.01071

(Short-term)	9001

0.00491

(Intermediate-term)	2,0001

1- Combined exposure is the sum of dermal and oral exposures.

Table 4.2b summarizes the postapplication exposure and risk for toddlers
resulting from contact with carpet and hard surfaces following crack and
crevice application of F4688 50 WP Insecticide/Termiticide on indoor
surfaces.  The bolded values represent the exposure to be aggregated
with exposure from food and drinking water.

TABLE 4.2b:  Postapplication Exposure and Risk Following Indoor
Crack/Crevice Treatment.

Scenario	Descriptor	Daily Dose

(mg/kg/day)	MOE

Dermal Exposure	Carpet and

Hard Surfaces	0.0195	510

Incidental Oral Exposure	Carpet and Hard Surfaces	0.0065	1500

Combined Dermal Incidental Oral Exposure	Carpet and Hard Surfaces	0.0260
380

5.0	Aggregate Risk Assessments and Risk Characterization  TC \l1 "5.0
Aggregate Risk Assessments and Risk Characterization 

Consistent with FQPA, HED considers aggregate risk to a pesticide from
the three major routes (dermal, oral, and inhalation) when potential
residential exposures exist.  In its acetamiprid aggregate assessment,
HED combined dietary (food + water) and non-dietary (residential)
exposure sources to obtain an estimated aggregate exposure.  When
aggregating exposures and risks from various sources, HED considers both
the route and duration of exposure.  Based upon the residential use
pattern of acetamiprid products, HED has determined that acute,
short-term, intermediate-term and chronic aggregate risk assessments are
appropriate.  

5.1	Acute Term Aggregate Risk TC \l2 "5.1	Acute Term Aggregate Risk 

The acute aggregate risk is equal to the acute dietary exposure via food
and drinking water, and therefore is identical to the exposure and risk
characterization found in Section 3.1.  The acute aggregate risks for
acetamiprid are less than 100% of the aPAD for all population subgroups
and, therefore, do not pose a risk concern for HED.

5.2	Short- and Intermediate-Term Aggregate Risk TC \l2 "5.2	Short- and
Intermediate-Term Aggregate Risk 

Short-term aggregate risk is based on the chronic (average) dietary
exposure (food + water) combined with short-term residential exposure. 
Intermediate-term aggregate risk is based on the chronic (average)
dietary exposure combined with intermediate-term residential exposure.

Short- and intermediate-term aggregate risks for residential handlers
were assessed previously by T. Moriarty (see Table 15, D303171,
10/25/07).  The aggregate MOEs for two adult populations (20-49 years;
50+ years) were 900 to 930.  Since the dietary exposure estimates are
now more refined due to the greater use of percent crop treated, these
aggregate risks would be even lower and are not of concern.

For short-term and intermediate-term aggregate risks, the combined
chronic dietary (food + water) exposure is combined with short- and
intermediate-term residential postapplication exposures for toddlers. 
The combined food, water and residential exposures are then compared to
the dose for risk assessment to determine the resulting margin of
exposure (MOE).  HED has updated the dietary component (food and water)
in this assessment.  In the case of acetamiprid, all short- and
intermediate-term risk assessments are based on the effects observed in
the DNT study, and therefore exposures from dermal and oral routes have
been combined.  See Table 5.2 for a summary of short- and
intermediate-term aggregate risks for toddlers.



TABLE 5.2:  Acetamiprid Short- and Intermediate-Term Aggregate Exposure

                                                     and Risk for
Toddlers.

Scenario	Combined Dermal/Oral Exposure

(mg/kg/day)1	Chronic Food Exposure Food

(mg/kg/day)2	Aggregate Exposure

(mg/kg/day)3	MOE4

Indoor Exposure Crack and Crevice Treatment

(short-term)	0.0260	0.010358	0.0364	270

Turf Exposure

(short-term)	0.0107	0.010358	0.0211	470

Turf Exposure (intermediate-term)	0.0049	0.010358	0.0153	650

Combined dermal and oral exposures were taken from D366701, S.
Oonnithan, 10/9/09.

Chronic food exposure does not change with each scenario; see Table
5.2.2.

Aggregate exposure = Combined dermal/oral exposure + chronic food
exposure.

MOE = NOAEL/Aggregate Exposure = 10 (mg/kg/day)/aggregate exposure
(mg/kg/day).

Short- and intermediate-term aggregate risks (MOEs) are not of concern. 
 HED notes that the lowest aggregate MOE of 270 is based on the indoor
use.  The MOEs calculated for exposure from turf are higher, but are
considered to be more conservative, because the intended use pattern
does not include broadcast treatment of lawns, but has been assessed as
such in order to be protective.  Adult aggregate risks due to
postapplication exposure have not been assessed since the toddler risks
are the worst case.

5.3	Chronic-Term Aggregate Risk TC \l2 "5.3	Chronic-Term Aggregate Risk 

The dietary exposure pathway (food and drinking water) is the only
source of chronic exposure to acetamiprid (i.e., 180 consecutive days or
more).  Therefore, the chronic aggregate exposure and risk estimates are
equivalent to the chronic dietary exposure and risk estimates discussed
in Section 3.1 above.  The chronic aggregate risks for acetamiprid are
less than 100% of the cPAD for all population subgroups and, do not pose
a risk concern for HED.

6.0	Data Needs and Label Recommendations  TC \l1 "6.0	Data Needs and
Label Recommendations 

The data needs and labels recommendations remain unchanged since the Dec
1, 2009 memorandum (D369474, D. McNeilly).

References:  TC \l1 "References: 

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3372890, 01/14/10, D. McNeilly.

Acetamiprid: Human Health Risk Assessment for Proposed Food Uses on
Clover Grown for Seed, Small Vine Climbing Fruits, except Kiwifruit,
Subgroup 13-07F, Greenhouse Grown Tomatoes and Tea.  . D369474,
12/01/09, D. McNeilly.

ഃЍ഍ഃЍ഍捁瑥浡灩楲। ††††††††偄丠⹯
›㜳㘲㘲഍倍条⁥–䅐䕇ᐠᔱ漠⁦–啎偍䝁卅ᐠ㐱ക഍
捁瑥浡灩楲।楄瑥牡⁹硅潰畳敲䄠獳獥浳湥ॴ偄丠⹯›
〳㜹〴倍⁃潃敤›㤰〹〵उ慐敧›
漠⁦–啎偍䝁卅尠‪牡扡捩尠‪䕍䝒䙅剏䅍⁔ㄔᔴ഍഍
഍഍倍条⁥–䅐䕇ᐠᔵ漠⁦–啎偍䝁ES  14 

Acetamiprid	Dietary Exposure Assessment	DP No.: 309740

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