UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 09/23/2014 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT : Isofetamid Chronic Aggregate Dietary (Food and Drinking Water) Exposure and 

Risk Assessment for the Section 3 Registration Action for Uses on Almonds, 

Lettuce (Head and Leaf), the Small Vine Climbing Fruit, except Fuzzy Kiwifruit, 

Subgroup 13-07F; the Low Growing Berry Subgroup 13-070; and the Rapeseed 

Subgroup 20A. 

PC Code: 270000 

Decision No.: 474283 

Petition No.: 3F8142 

Risk Assessment Type: Dietary 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: D4111 09 

Registration No.: 71512-EE 

Regulatory Action: Section 3 Registration 

Case No.: NA 

CAS No.: 875915-78-9 

40 CFR: § 180.xxx (to be determined) 

FROM: Na

Risk 

ncy 

Assessment 

Dodd, Chemist 

Branch 

~ 

III (RAB3) 

~ 

THROUGH: 

TO: 

Health Effects Division (HED, 7509P) 

Douglas Dotson, Ph.D., Chemist ,t_ J~ . · . I · Julie Van Alstine, Environmental Health Scientist ~ v'~ Dietary Exposure Science Advisory Council (DESAC) 

Tony Kish, RM#22 

Registration Division (7509P) 

and 

Nancy Keller, Risk Assessor 

RAB3/HED (7509P) 

Executive Summary 

A chronic aggregate dietary (food and drinking water) exposure and risk assessment was 

conducted using the Dietary Exposure Evaluation Model software with the Food Commodity 

Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption 

data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition 

Examination Survey, What We Eat in America (NHANESIWWEIA). The analysis was 

Page I of II 
lsofetamid Dietary Exposure and Risk Assessment DP Number: 0411109 

conducted in support of a human-health risk assessment for the proposed Section 3 uses of 

isofetamid on almonds, lettuce (head and leaf), the small vine climbing fruit, except fuzzy 

kiwifruit, subgroup 13-07F; the low growing berry subgroup 13-070; and the rapeseed subgroup 

20A. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 

2012.1. 

Acute Dietary Exposure Assessment 

An acute dietary risk assessment was not performed since there were no appropriate 

toxicological effects attributable to a single exposure (dose) observed in oral toxicity studies. 

Chronic Dietary Exposure Assessment 

A partially refined chronic dietary (food and drinking water) exposure assessment was conducted 

for all proposed food uses of isofetamid. Anticipated residues based on field trials were used for 

all commodities. Empirical and default processing factors were used, as available. 1 00% crop 

treated (CT) was assumed for all commodities. The estimated drinking water concentration 

(EDWC) for the chronic assessment was 110 J.lg/L (ppb ). This value was the 1-in-1 0 year 

chronic value from the index reservoir model, PFAM (Pesticides in Flooded Application Model), 

based on use on cranberries in WI. 

The chronic dietary exposure estimates for food and drinking water are below HED's level of 

concern (<100% cPAD) for the general U.S. population and all population subgroups. 

lsofetamid dietary exposure for food and drinking water is <1% of the cPAD for the general U.S. 

population and < 1% of the cP AD for children 1-2 years old, the most highly exposed population 

subgroup. 

Cancer Dietary Exposure Assessment 

A cancer dietary assessment was not conducted as isofetamid has been classified as "not likely to 

be carcinogeni~ to humans" based on the absence of significant tumor increases in two adequate 

rodent carclnogenicity studies. 

I. Introduction 

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose thatHED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors. 

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 1 00% of the PAD. References that discuss the acute and chronic risk assessments in 

more detail are available on the EPA/pesticides web site: "Available Information on Assessing 

Exposure from Pesticides, A User's Guide," 21-JUN-2000, web link: 

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lsofetamid Dietary Exposure and Risk Assessment DP Number: 041 1109 

http://www.regulations.gov/#!documentDetail;O=EPA-HQ-OPP-2007-0780-0001; or see SOP 

99.6 (20-AUG-1999). 

This is the first dietary risk assessment for isofetamid. 

II. Residue Information 

The proposed uses are the first food uses for isofetamid. No tolerances have been established in 

40 CFR Part 180. HED is recommending for the tolerances shown in Table 1 below. 

Table 1. Tolerance Summary for Isofetamid. 

Commodity HED-Recom mended 

Tolerance (oom) 

Almond 0.01 

Almond, hulls 0.01 

Berry, low growing, subgroup 13-070 4.0 

Canola, refined oil 0.03 

Flax, seed, oil 0.03 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F 3.0 

Grape, raisin 5.0 

Lettuce, head 5.0 

Lettuce, leaf 7.0 

Mustard, seed, oil 0.03 

Rapeseed subgroup 20A 0.015 

Sesame, oil 0.03 

As determined by the Residues of Concern Knowledgebase Subcommittee (ROCKS; D41111 0, 

Ideliz Negron-Encarnacion, 5/21114), the residue of concern for food (primary plants) for the 

tolerance expression is isofetamid (parent only). The residues of concern for food (primary 

plants) for the risk assessment are isofetamid and the metabolite GPTC. The residue of concern 

for drinking water is parent only. Tolerances on livestock commodities and rotational crops are 

not required at this time. 

The chronic assessment is a partially refined assessment using anticipated residues. The average 

(mean) field trial residues were used for all commodities. 100% CT was assumed for all 

commodities. Since processing studies were available on canola and grapes, empirical 

processing factors were used for rapeseed oil, flax seed oil, and sesame oil (all 1.97x based on 

the canola processing study) and raisins (2.2x). Residues did not concentrate in grape juice and 

wine, so a processing factor of 1x was applied (0411108, N. Dodd, 6/20/14). A DEEM default 

processing factor was used for cranberry juice (1.1 x); no other default processing factors were 

applicable. Refer to Appendix 1 for data and residue estimates used in the dietary exposure 

analysis. 

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, 

and 2010. In general, pesticide residues would not be expected to be found in fish unless the 

pesticide bioaccumulates or has an aquatic use. To determine whether or not residues are present 

in fish, HED now routinely checks PDP monitoring data regardless of the pesticide's uses and 

physicochemical properties. However, PDP did not analyze catfish samples for isofetamid since 

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Isofetamid Dietary Exposure and Risk Assessment DP Number: D41 1109 

isofetamid is a new active ingredient. As a result, residues in fish were not included in this 

assessment. 

III. Percent Crop Treated Information 

100% CT was assumed for all commodities. 

IV. Drinking Water Data 

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED) in the following memorandum: "Isofetamid: 

ADDENDUM to Drinking Water Exposure Assessment for the Section 3_Registration of the 

New Chemical Isofetamid, in Support ofProposed Almond, Lettuce, Grapes (Subgroup l3-07F), 

Low Growing Berries (Subgroup 13-07G), Rapeseed (Subgroup 20A), and Turf Uses" 

(D422934, M. Biscoe, 9/22114) and incorporated directly into this dietary assessment. Water 

residues were incorporated in the DEEM-FCID into the food categories "water, direct, all 

sources" and "water, indirect, all sources." 

As shown in Table 2 below, the EDWC for the chronic assessment was 110 g/L (ppb). This 

surface water value was the 1-in-1 0 year chronic value from the Pesticide Flooded Applications 

Model (PF AM), based on use on cranberries in WI. The surface water value was used because it 

was higher than the groundwater chronic value from the Pesticide Root Zone Model - Ground 

Water (PRZM-GW). 

Table 2. Maximum Estimated Drinking Water Concentrations (EDWCs) in parts per billion 

(Jlg/L) Resulting from Applications of Isofetamid on the Proposed Low-Growing Berries 

Subgroup 13-07G and TurfUses. 1 

Drinking Water Acute Chronic 

Source (model) Application Information 

Jlg/L 

5 applications of0.442 lb Peak Chronic 

Pesticide Flooded a.i./acre with a 7-day 1-in-10 Year 1-in-10 Year 

Applications retreatment interval and a 

Model (PF AM) 30-day resistance 136 110 

management interval 

Wisconsin Corn Scenario 

Peak Post-Breakthrough Average 

Groundwater Turf 

(PRZM-GW 30- 7 Ground Applications year simulation) Total: six of0.567 lb 49 43 

ai/acre and one of0.248 lb 

ai/acre 1 The value used m the chrome assessment ts bolded. 

The drinking water models and their descriptions are available at the EPA internet site: 

http://www .epa. gov I oppefed 1 /models/water/. 

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Isofetamid Dietary Exposure and Risk Assessment DP Number: 041 I I 09 

V. DEEM-FCID Program and Consumption Information 

Chronic dietary exposure assessments were conducted using the DEEM-FCID, Version 3.1 6, 

which incorporates 2003-2008 consumption data from USDA's NHANES/WWEIA. The data 

are based on the reported consumption of more than 20,000 individuals over two nonconsecutive survey days. Foods "as consumed'' (e.g., apple pie) are linked to EPA-defined food 

commodities (e.g., apples, peeled fruit- cooked; fresh or N/S; baked; or wheat flour- cooked; 

fresh or N/S, baked) using publicly available recipe translation files developed jointly by 

USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the 

entire U.S. population and within population subgroups. However, for acute exposure 

assessment, consumption data are retained as individual consumption events. Based on analysis 

of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and 

survey respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-1 2, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years 

old. 

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mglkg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup. 

VI. Toxicological Information 

In repeated dose studies, the liver was the primary target organ in the rat, mouse, and dog, as 

indicated by increased liver weights, changes in the clinical chemistry values, and liver 

hypertrophy. A second target organ was the thyroid in the rat and dog, as indicated by changes 

in thyroid weights and histopathology. Adrenal weight changes were observed in the subchronic 

mouse and dog studies. There were no neurotoxicity or immunotoxicity concerns. Mutagenicity 

studies were negative, and no tumors were noted in the rat and mouse carcinogenicity studies 

resulting in a cancer classification of"not likely to be carcinogenic to humans." 

The isofetamid risk assessment team has recommended that the Food Quality Protection Act 

(FQPA) Safety Factor be reduced to 1 X because there is an adequate toxicity database for 

isofetamid and exposure data are complete or are estimated based on data that reasonably 

account for potential exposures. There is no evidence of susceptibility and there are no residual 

uncertainties concerning pre- or post-natal toxicity. Acute and subchronic neurotoxicity studies 

are available, and all endpoints used in this risk assessment are protective of any neurotoxic 

effects. The dietary and residential assessments are based on reliable data and will not 

underestimate exposure. 

As seen in Table 3, an endpoint attributable to a single dose was not identified for an acute 

dietary endpoint for all populations, including females 13-50 years old, infants, and children. 

Page 5 of I I 
lsofetamid Dietary Exposure and Risk Assessment DP Number: D4111 09 

The NOAEL of76.6 from a multi-generation reproduction study was chosen as the point of 

departure for chronic dietary exposures (all populations). This NOAEL was considered 

protective of all the effects of concern seen in the other studies in the database and represents an 

exposure duration appropriate for the chronic scenario. 

Table 3. Toxicological Doses and Endpoints for Isofetamid for Use in Dietary Health Risk 

Assessments. 

Exposure/ Point of Uncertainty/ RID, PAD, Level 

FQPA Safety of Concern for Study and Toxicological Effects 

Scenario Departure Factors Risk Assessment 

Acute Dietary There were no appropriate toxicological effects attributable to a single exposure (dose) observed in 

(All oral toxicity studies. Therefore, a dose and endpoint were not identified for this risk assessment. 

Populations) 

Chronic NOAEL = 76.6 UFA= lOx Chronic RID = 0.77 Reproduction and fertility effects 

Dietary (All mg/kg/day UFH= !Ox mg/kg/day (rat) 

Populations) FQPA SF= lx LOAEL = 6791775 mg/kg/day 

cPAD = 0.77 based on microscopic changes in 

mg/kg/day the liver and thyroid in both sexes 

and generations, decreased spleen 

weights in F, males, and decreased 

pup body weight in both sexes and 

generations. 

Cancer (oral, Classification: "Not likely to be Carcinogenic to Humans" based on the absence of significant 

dermal, tumor increases in two adequate rodent carcinogenicity studies. 

inhalation) 

Point of Departure (POD) = A data pomt or an estimated pomt that IS denved 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). RID = reference dose. 

VII. Results/Discussion 

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of 

the PAD. The DEEM-FCID analyses estimate the dietary exposure and risk ofthe U.S. 

population and various population subgroups. The results reported in Table 4 are for the general 

U.S. Population, all infants ( <1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years. 

Results of Chronic Dietary (Food and Drinking Water) Exposure and Risk Analysis 

The results of the chronic dietary exposure and risk analysis are reported in the summary table 

below. 

Page 6 of ll 
lsofetamid Dietary Exposure and Risk Assessment DP Number: 0411109 

Table 4. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Isofetamid. 

Acute Dietary Chronic Dietary Cancer 

Population Subgroup Dietary Dietary Dietary 

Exposure % aPAD* Exposure % cPAD* Exposure Risk 

(mg!kg/day) (me:/ke:lday) ( ml!/ke:/dav) 

General U.S. Population 0.003070 <I 

All Infants (<I year old) 0.006959 <I 

Children 1-2 years old* 0.006560 <1 

Children 3-5 years old 0.004900 <I 

Children 6-12 years old NA NA 0.002986 <I NIA N/A 

Youth 13-19 years old 0.002140 <I 

Adults 20-49 years old 0.002875 <I 

Adults 50-99 years old 0.0029 16 <I 

Females 13-49 years old 0.002913 <I 

*The subpopulat1on w1th the h1ghest nsk est1mate IS bolded. 

VIII. Characterization of Inputs/Outputs 

The chronic assessment is a partially refined assessment using anticipated residues based on field 

trial data. The mean residue values were used for all commodities. I 00% crop treated was 

assumed for all commodities. Empirical processing factors were used for rapeseed oil, flax seed 

oil, and sesame oil (all 1.97x based on the canola processing study) and raisins (2.2x). Residues 

did not concentrate in grape juice and wine, so a processing factor of lx was applied. A DEEM 

default processing factor was used for cranberry juice ( 1.1 x); no other default processing factors 

were applicable. The chronic assessment could be refined by using percent crop treated for new 

uses. However, as there are no risk estimates of concern, no further refinements were 

incorporated. 

IX. Conclusions 

A partially refined chronic assessment was performed. Anticipated residues based on field trials 

were used for all commodities. Empirical and default processing factors were used as available. 

100% CT was assumed for all commodities. No monitoring data were used. All population 

subgroups have risk estimates that are below HED's level of concern. HED is confident that the 

assessment does not underestimate risk to the general U.S. population or any population 

subgroup. 

X. List of Attachments 

Attachment l : Data and Residue Estimates Used in the Dietary Exposure Analyses 

Attachment 2: Chronic Residue Input file 

Attachment 3: Chronic Food and Water Results File 

Attachment 4: Chronic Water Only Results File 

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lsofetamid Dietary Exposure and Risk Assessment DP Number: 0411 109 

Attachment 1. Data and Residue Estimates Used in the Dietary Exposure Analyses 

Table A.l. Data and Residue Estimates Used in the Dietary Exposure Analyses.' 

Anticipated Residue 

Estimates/Tolerance 

Food Blending Data No. of No. of % Processing (ppm) 

RAC Classifi- Source Detectable LOD5 Acute 

Fonns cation2 (MRID) Samples3 

Residues4 CT Factors (To!., Chronic 

AR, (AR = mean) 

RDF) 

Almond Nutmeat PB 4901I97I 5 0 O.OI75 IOO NA 0.0175 

Canol a Seeds B 49011973 I7 3 0.0175 IOO NA O.OI8 

Canola6 Oil B 490II973 -- -- O.OI75 100 1.97 0.018 

Cranberry Fruit PB Refer to strawberry since strawberry is the representative 0.753 commodity for subgroup I3-07G. 

Flaxseed Oil B 

Refer to canola oil since canola is the representative commodity 0.018 for the rapeseed subgroup 20A. 

Gooseberry Fruit PB Refer to grape (fruit) since grape is the representative commodity 0.783 for subgroup 13-07F. 

Grape Fruit PB 490JI972 15 15 0.0175 IOO NA 0.783 

Grape Juice PB 490I8434 -- -- 0.0175 100 O. I6 NA 0.783 

Grape Leaves PB No residue data are required for grape leaves. The residue level 0.783 for grape fruit is used for leaves. 

Grape Raisin PB 490 18434 -- -- 0.0175 100 2.2 0.783 

Grape Wine PB 49018434 -- -- 0.0175 100 0.32 0.783 

Lettuce, Head NB 490I8435 II 10 0.0175 100 NA 0.625 head 

Lettuce, Leaves PB 490 I8435 12 12 0.0175 100 NA 0.784 leaf 

Sesame Seeds B Use canota seed data. 0.018 

Sesame Oil B Refer to canola oil since canota is the representative commodity 0.018 for the rapeseed subgroup 20A. 

Strawberry Fruit PB 49011959 II 11 0.0175 100 NA 0.753 

I. LOD = hnnt of detect ton; % CT = percent crop treated; To I = Tolerance; RDF = Rest due DtstnbuttOn Ftle; AR = Anticipated Residue; NA = not applicable. 

2. Classification: blended (8), partially blended (PB), not blended (NB). 

3. The number of samples is equivalent to the number of field trials. 

4. Includes combined residues of parent and its metabolite GPTC, expressed as parent equivalents. 

5. The reported LOD is the sum of the LOD of parent (0.01 ppm) and the LOD ofGPTC (0.0075 ppm). 

6. Canola was genetically engineered from rapeseed. Canola oil residues are entered in the dietary analysis as rapeseed 

oil residues. 

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lsofetamid Dietary Exposure and Risk Assessment DP Number: 04 11109 

Attachment 2: Chronic Residue Input file 

Filename: C:\Users\ndodd\Oocuments\DEEM Version 3.16\Isofetami d 2014\isofetamid chroni c 

091914 .R08 

Chemical: Isofetamid 

RfD(Chronic): .77 mg/kg bw/day NOEL(Chronicl: 0 mg/ kg bw/day 

RfD(Acute): 0 mg/kg bw/day NOEL(Acut e): 0 mg/kg bw/day 

Date created/last modified: 09- 19-2014/11:39: 15 Program ver. 3.16, 03-08-d 

EPA Crop Oef Res Adj.Factors Comment 

Code Grp Commodity Name (ppm) #1 #2 

-··------- ------------------------------- ---------- ------- 0401204000 4A Lettuce, head 0.625000 1 .000 1.000 

0401205000 4A Lettuce, leaf 0 . 784000 1 .000 1.000 

1302174000 13B Gooseberry 0.783000 1.000 1.000 

1304175000 130 Grape 0.783000 1.000 1.000 

1304176000 1 30 Grape, juice 0.783000 1 .000 1.000 041110 

Full comment: 0411108 

1304176001 130 Grape, juice-babyfood 0.783 000 1.000 1.000 

1304179000 130 Grape, wine and sherry 0.783000 1.000 1.000 041110 

Full comment: 0411108 

1307130000 13G Cranberry 0.753000 1.000 1.000 

1307130001 1 3G Cranberry-babyfood 0.753000 1.000 1 .000 

1307131000 13G Cranberry, dried 0.753000 1. 000 1.000 

1307132000 13G Cranberry, juice 0 .753000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 0.753000 1.100 1.000 

1307359000 13G Strawberry 0.753000 1 .000 1.000 

1307359001 13G Strawberry-babyfood 0.753000 1.000 1.000 

1307360000 1 3G Strawberry, JUl.Ce 0.753000 1 . 000 1.000 

1307360001 13G Strawberry, juice-babyf ood 0.753000 1.000 1.000 

1400003000 1 4 Almond 0.017500 1.000 1 .000 

1400003001 14 Almond-babyfood 0.01 7500 1 . 000 1 . 000 

1400004000 14 Almond, oil 0.01 7500 1 . 000 1 . 000 

1400004001 14 Almond, oil - babyfood 0.017500 1. 000 1.000 

2001163000 20A Flax seed, oil 0.018000 1.970 1.000 

2001319000 20A Rapeseed, oil 0.018000 1.970 1.000 041110 

Full comment: 0411108 

2001319001 20A Rapeseed, oil-babyfood 0.018000 1 .970 1.000 

2001336000 20A Sesame, seed 0.018000 1.000 1.000 

2001336001 20A Sesame, seed-babyfood 0.018000 1.000 1.000 

2001337000 20A Sesame, oil 0.018000 1.970 1.000 

2001337001 20A Sesame, oil- babyfood 0.018000 1.970 1.000 

8601000000 86A Water, direct, all sour ces 0.110000 1. 000 1.000 

8602000000 86B Water, indirect, all sources 0.110000 1.000 1.000 

95001770 00 0 Grape, leaves 0.783000 1 .000 1.000 

9500178 000 0 Grape, raJ.sJ.n 0.783000 2 .200 1.000 041110 

Fu ll comment: 04 11108 

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lsofetamid Dietary Exposure and Risk Assessment DP Number: 04 I I I 09 

Attachment 3: Chronic Food and Water Results File 

US EPA Ver. 3.16, 03-08-d 

DEEM-FCID Chronic analysis for ISOFETAMID NHANES 2003-2008 2-day 

Residue file name: C:\Users\ndodd\Documents\DEEM Version 3.16\Isofetamid 2014\isofetamid chronic 

091914.R08 

Adjustment factor #2 used. 

Analysis Date 09-19-2014/11:41:58 Re sidue file dated: 09-19-2014/11:39:15 

Reference dose (RfD, Chronic) = .77 mg /kg bw/day 

Total exposure by population subgroup 

Total Exposure 

Population 

Subgroup 

Total us Population 

Hispanic 

Non-Hisp-White 

Non- Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1 -6 

Children 7-12 

Male 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1- 2 

Children 3-5 

Children 6- 12 

Youth 13 - 19 

Adults 20-49 

Adults 50-99 

Female 13-49 

mg/ kg Percent of 

body wt /day Rfd 

--------- ---- ................................... 

0.003070 0 . 4\ 

0 . 002837 0 . 4% 

0.003175 0 . 4'1; 

0 . 002614 0. 3\ 

0.003357 0.4\ 

0 . 002469 0.3% 

0.008963 l.a 

0. 002722 0.4\ 

0.005394 0. 7'1; 

0.002753 0.4\ 

0.001993 0. 3\ 

0.002285 0.3\ 

0.002681 0.3\ 

0.003091 0.4\ 

0.002900 0.4\ 

0.006959 0.9\ 

0.002913 0.4\ 

0.006560 0.9\ 

0.004900 0.6\ 

0.002986 0.4\ 

0.002140 0.3\ 

0.002875 0. 4\ 

0.002916 0.4\ 

0.002913 0.4\ 

Page 10 of 1 I 
lsofetamid Dietary Exposure and Risk Assessment DP Number: 041 1109 

Attachment 4: Chronic Water Only Results File 

US EPA Ver. 3 . 16, 03-08 - d 

DEEM- FCID Chronic ana l ysis for ISOFETAMID NHANES 2003-2008 2-day 

Residue file name: C:\Users\ ndodd\Documents\DEEM Ver sion 3.16\Isofetamid 2014\isofetamid chronic 

water only 091914.R08 

Adjustment factor #2 used. 

Analysis Date 09-19 - 2014/11:44:31 Residue file da ted: 09-19-2014 / 11 :37:47 

Re f e rence dose (Rf D, Chronic) = .77 mg/kg bw/day 

==========••=================•=============================a= • ============ ===== 

To tal exposure b y population subg roup 

Population 

Subgroup 

Total us Popul a t i on 

Hispanic 

Non -Hisp-White 

Non-Hisp- Black 

Non- Hisp-Other 

Nursi ng Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1-6 

Children 7 - 12 

Male 13 - 19 

Fe male 13 - 19/NP 

Ma le 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13 - 50 

Children 1-2 

Childr en 3 - 5 

Children 6-12 

Youth 13-19 

Adults 20-49 

Adults 50 - 99 

Female 13-49 

Total Exposure 

mg/kg Percent of 

body wt/day Rf d 

------------- ---------------- 0.002303 0 . 3% 

0.00219 9 0. 3% 

0.002369 0 . 3% 

0.001 901 0 . 2% 

0.002655 0 .H 

0.002084 0 .3t 

0.007661 l.Ot 

0.0021 69 0 . 3\-

0.002950 0 . 4\ 

0.001920 0 .2% 

0.001 583 0 .2% 

0.001774 0 . 2% 

0.002 14 6 0. 3t 

0.002419 0.3\' 

0.002227 0 .3t 

0.005939 0.8% 

0.002292 0 . 3% 

0.003323 0.4% 

0.002799 0 . 4% 

0 .002 01 9 0 . 3% 

0.001680 0 . 2'1; 

0.002298 0 . 3\ 

0. 002272 0 . 3\' 

0.002290 0. 3% 

Page II of II