UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C. 20460

MEMORANDUM Date: 09/23 /2014 OFFICE OF CHEMICAL SAFE T Y AND POL L UTION PREVENTION

SUBJECT : Isofetamid Chronic Aggregate Dietary (Food and Drinking Water) Exp os ure and Risk Assessment for the Section 3 Re gistration Action for Uses on Almonds, Lettuce (Head and Leaf) , the Small Vine Climbing Fruit, except Fuzzy Kiwifruit, Subgroup 13-07F; the Low Grow ing Berry Subgroup 13 -07 0; and the Rapeseed Subgroup 20A. PC Co de : 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 N o.: 875915-78

- 9 40 CFR: 

### § 180.xxx (to be determined) FROM: Na ncy Dodd, Chemist

### ~**~** Risk Assessment B ranch III (RAB3)
THROUGH:

TO: Health Effec ts Divis ion (HED, 7509P) Douglas Dotson, Ph.D., Chemist 

## ,t_**J~** 

# . · . I · Julie Van Alstine, Environmental Health Scientist

## ~**v'~** Dietary Expos ure Science Advisory Council (DE SAC) Tony Kish , RM#22 Registration Division (7509 P) and Nanc y Keller, Risk Assessor RAB3/HED (7509 P) Executive Sum m ary A chronic aggregate dietary (food and drinking water) exposure and risk asse ssment was conducted using the Dietary Exposure Eva lu ation Model software with the Food Commodity In take Database ( DEEM-FC ID) Vers io n 3. 16
. Thi s software uses 2003-2008 food consumption 

### data f rom the U.S
. Departm ent of Agriculture 's (USDA's) National Health and Nutr ition Examinat ion Survey, What We Eat in America (NHANESIWWEIA). The analysis was Page I of IIlsofetamid 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
. Empirica l 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 1 10 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 f or 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 i s <1% of the cPAD for the general U.S. population and < 1% of the cPAD for children 1

- 2 years old, the most highly exposed population subgroup
. Cancer Dietary Exposure Assessment A cancer diet ary 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 wi ll 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," 2 1-JUN -2 000, web link:

Page 2 of 11lsofetamid Di etary Exposure and Risk Assessment DP Number: 041 1 109 http: //www.regulation s.g ov/ # !documentDetail;O=EPA-H Q-OPP- 2 007- 0780-0001; or see S OP 99.6 (20-AUG-1999). This is the first dietary risk assess ment fo r i sofetamid. 

### II. Residue Information The proposed uses are the first foo d us es for isofetamid. No tol erances have been established in 40 CFR Pa rt 180
. HED is recommending for the tolerances shown in Tab le 1 below
. Table 1. Tolerance Summary for Isofetamid. Co mmodi ty HED-Recom mended Tolerance (oom) A lmond 0.01 Almond , hulls 0.01 Berry, low growing, s ubgroup 13-070 4 .0 Ca nola, refined oil 0.03 Flax, seed , oil 0.03 Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07 F 3.0 G rap e, rai s in 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 o f Concern Knowledgebase Subcommittee (RO CKS; D41111 0, Ideliz Negron-Enc arnacion, 5/21114), the residue of concern fo r food (primary plants) for the tol erance expression is isofetamid (p are nt only). T he residues of concern for food (primary plants) for the risk assessment ar e is ofetamid and the metabolite GPTC. The residue of concern for drinking water is parent only
. Tolerances on livestock commodities and rotational crops are not requi red at this time. The chronic assessment is a partially refined assessment using anticipated residue s. The average (mean) field trial re s idu es were use d for all commodities. 100% CT was assumed for all commodities. S ince processing stud ies were ava ilable on cano la and grapes, empirical proce ss ing factors were used for rapeseed oil , flax seed oil, and sesame oi l (all 1.97x based on the canola processing study) an d raisins (2 .2x). Res idues did n ot co nc entrate in grape j uice and wine, so a process ing factor of 1x was applied (0411108 , N. D odd, 6 /20/14). A DEEM default processing factor was used for cranberry juice (1.1 x); no other default process ing factors were appli cable. Refer to Ap pendi x 1 for data and residue estimate s used in the dietary exposure analysis. The USDA Pesticide Data Program (PDP) monitored pesticide res idues in catfish in 2008, 2009, and 2010. In general, pesticide residues would not be expected to be found in fish unless the pestic ide bioaccumulates or has an aquatic use. To determine whether or not res idues are present in fish, HED now routinely checks PDP moni to ring data reg ard le ss of t he p esticide' s uses and phy s icochemica l properties. However , PD P did not analyze catfish samples for isofetamid s ince

Page 3 of IIIso fetamid Dietary Exposure and Risk Assessment DP Number: D41 1109 isofetamid is a new active ingredient. As a result, residu es in fish were not included in this assessment. 

### III. P ercent 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 Ef fects Division (EFED) in the following memorandum : "Isofetamid : ADDENDUM to Drinking Water Exposure Assessment for the Section 3

_ Regis tration of the New Chemical Isofetamid, in Support ofProposed A lmond, Lettuce , Grapes (Subgroup l3-07F), Low Growing Berries (Subgroup 13-07G), Rapeseed (Subgroup 20A), and Turf Uses" (D422934, M. Biscoe, 9/22114) and inc orporated directly into this dietary assessment. Water residues were incorporated in the DEEM

- FCID into the food categori es "wa ter, direct, all s ources" and "water, indirect, all sources . " As shown in Table 2 below, the EDWC for the chronic assessment was 110**g/L** (ppb). Thi s surface water value was the 1-in-1 0 year chronic value from the Pe sticide Flooded App lic ation s Model (PFAM), 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 of0.44 2 lb Peak Chronic Pestici de Flooded a.i./acre with a 7-day 1-in-10 Year 1-in-10 Year App lications retreatment interval and a Model (PF AM) 30-day resis tance 136 110 management interval Wisconsin Corn Scenario Peak Post-Breakthr ough Average Groundwater T u rf (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/wa ter /.

Page 4 of 11Isofetamid Dietary Exposure and Risk Assessment DP Number: 041 I I09 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 indi vidua ls over two non
consecutive 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 da ta are averaged for the entire U.S. populat ion and within population subgroups. However, for acute exposure assessment, consumpt ion 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 concl uded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), chi ldren 1-2, children 3 -5 , children 6-1 2 , youth 13-19, adults 20-49, fema les 13-49, and adults 50-99 years old. For a chronic dietary exposure assessment, a n 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 f orm is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the to tal average estimated exposure. Exposure is exp re ssed 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 st ud ies, 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 class ification 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 comp lete or are estimated based on data that reasonably account for potential exposures. There is no evidence of susceptibility and there are no residual uncertai nti es concerning pre- or post-natal toxicity. Acute and subchronic neurotoxicity s tudie s are availab le , 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 s ingle 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 Ilsofetamid Dietary Expo sure and Risk Assessment DP Number: D4111 09 The N OAEL 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 s cenario
. Table 3. Toxicological Doses and Endpoints for Isofetamid for Use in Dietary Health Risk Assessments.

Ex posure/ Point of Uncertainty/ RID, PAD, Level FQPA Safety of Concern for Study and Tox icological Effects Scenario Departure Factors Risk Assessment Acute Di etary 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 identi fie d for this risk assessment. Populations) Chronic NOAEL = 76.6 UFA = lOx Chronic RID = 0.77 Reproduction and fertil ity 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 generati ons, 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. N OAEL =n o observed adverse effect leve l. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapo lation 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, fo r 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. T he 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 -1 2, youth 13

- 19, females 13-49 , adults 20-49, and adults 50-99 years . Re sults of Chronic Dietary (Food and Drinking Water) Exposure and Risk Analysis The resul ts of the chronic dietary expo sure and risk analysis are reported in the summary table below.

Page 6 of lllsofetamid Dietary Exposure and Risk Assessment DP Number: 0411109
Tab le 4
. S umm ary of Dietary (Food and Dr inking Water) Exposure and Risk for Isofetamid. Acute D ietary Chronic D i etary 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 C h i ldren 1-2 yea r s o ld * 0.006560 <1 Children 3 -5 years ol d 0
.004900 <I Children 6-12 years old NA NA 0.002986 <I NI A N/ A Youth 13

- 19 years old 0.002140 <I Adults 20-49 years old 0.002875 < I Adu l ts 50

- 99 years o ld 0.0029 1 6 < I Females 13

-49 years o ld 0.002913 < I *The subpopulat1on w1th the h1ghest nsk est1mate IS bolded
. VIII
. C haracte r ization o f Inp u ts/Outp uts The chronic assessment is a partially refined assessment us ing ant ic ipated residues based on field trial data. The mean residue values were used fo r all commodities. I 00% crop treated was assumed for all commodities. Empirical processing factors were used fo r rapeseed o il , flax seed oi l , an d sesame oil (all 1.97x based on the cano la process ing st u dy) and raisins (2.2x)
. Residues did not concentrate in grape j uice and wine, so a processing factor of l x was app lied. A DEEM default processing factor was used for cranberry juice ( 1.1 x); no other default processing factors were applicable. Th e chronic assessment could be refined by using percent c rop treated for new uses. However, as there are no risk estimates of concern , no further refinements wer e incorporated. IX. C on clu s io n s A partially refined c hronic assess ment was performed. Anticipated res idues based o n fie ld tr ials we r e use d for all co mm odities. Empirical and default proce ssing factors were used as avail ab le. 100% CT was assumed for all commodities. No monitoring data were used. All populati on subgroups have risk estimates that are below HED's level of concern. HE D is confident that the assessment does not underestimate risk to the general U
. S. p opu lation or any popul atio n subgro up . X. L i st of Attachments Attac hment l : Data an d Residue Estimates Used in the D ietary Exposure Analyses Attachment 2: Chronic Res idue I np ut file Attachment 3: Chronic Food and Water Results File Attachment 4: Chronic Water O nly Resu lts File

Page 7 of IIlsofetamid 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 Est im ates Used in the Dietary Exposure Analyses.' Anticipated Residue E stimates/Tol erance Food B lending Data No
. of No. of % Processing (ppm) RAC C lassifi

- Source Detectable LOD 5 Acute Fonns cation2 (MRID) Samples3 Residues4 CT Factors (To !., C hronic AR, ( AR = mean) RDF) Almond Nutmeat PB 4901I97I 5 0 O.OI75 IOO NA 0.0175 Canola Seeds B 49011973 I7 3 0.0175 IOO NA O.OI8 Canola6 Oil B 4 90II97 3 

## -- -- O.OI75 100 1.97 0.018 Cranberry Fruit PB Refer to strawberry since strawberry is the representative 0.753 commodity f or subgroup I 3 -07G. Flaxseed Oi l B Refer to canola oil since canola is the representative commo di ty 0.018 fo r the rapesee d subgroup 20A. Gooseberry Fruit PB Refer to grape (fruit) since grape is the representativ e commodity 0.783 for subgroup 13-07F. Grape Fruit PB 490JI972 15 15 0.0175 IOO NA 0.783 Grape Ju ice 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 f or leav es. 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 I8 435 1 2 12 0.0175 100 N A 0.784 leaf Sesame Seeds B Use cano ta seed data. 0.018 Sesame Oil B Re f er to canola oil since canota is the re presentative commodity 0.018 for the rapeseed subgroup 20A. Strawberry Fru it PB 49011959 II 11 0.0175 100 NA 0.753 I. LOD = hnnt of detectto n; % CT = percent crop treated ; ToI = 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 samp les is equival ent to the number of field trials. 4
. Includes combined residues of parent and its metabolite GPTC , expressed as parent equivalent s. 5. The reported LOD is the sum of the LOD o f parent (0.01 ppm) and the LOD ofGPTC (0.0075 ppm). 6. Canola was genetically engineered from rapeseed. Canola oil res idu es are entered in the dietary analysis as rapeseed oil r esidues.

Page 8 of I Ilsofetamid Dietary Exposure and Risk Assessment DP Number: 04 1 1109
A ttachment 2: C hro nic Re s idue Input file
Filename: C:\Users\ndodd\Oocuments\DEEM Version 3.16\Isofetami d 2014\isofetam id chron i c 09191 4 .R08 Chemical: Isofetamid RfD(Chronic): .77 mg/kg bw/day N OEL(Chronicl: 0 mg/ k g bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acu t e): 0 mg/kg bw/day Da te created/last modified: 09- 1 9-20 1 4/11:39: 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 Fu ll comment: 04111 0 8 1304176001 130 Grape, juice-babyfood 0.783 0 00 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 130713000 1 1 3G Cranberry-babyfood 0.753000 1.000 1 .000 1307131000 13G Cranberry, dried 0.753000 1. 000 1.000 1307132000 13G Cranberry, juic e 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 130735900 1 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 0.0 1 7500 1
. 000 1
. 000 1400004000 14 Almond, oil 0.0 1 7500 1
. 000 1
. 000 1400004001 1 4 Almond, oil

- babyfood 0.017500 1. 000 1.000 200 1163000 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 .97 0 1.000 2001336000 20A Sesame, seed 0.018000 1.000 1.000 2001336001 20A Sesame, seed-baby food 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 sou r ces 0.110000 1. 000 1.000 8602000000 86B Water, indirec t, all sources 0.110000 1.000 1.000 95001770 0 0 0 Grape, leaves 0.783000 1 .000 1.000 9500178 0 00 0 Grape, raJ.sJ.n 0.783000 2 .200 1.000 041110 F u ll comment: 04 11 108

Page 9 of 1 1l so feta mid D ietary Exp os ure a nd Ri sk A ssess m e nt DP Numb er: 04 I I I09 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 R e sidue file dated: 09-19-2014/11:39:15 Reference dose (RfD, Chronic) = .77 m g /kg bw/d ay Total exposure by population subgroup
Total Exposure Population

Subgroup Total u s Population Hispanic N

on-Hisp- W hite 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 m g / k g Percent of body wt /day Rf d

--------- - - -- ................................... 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 Il sofetamid Dietary Expos ure and Risk Assessment DP N u mber: 041 1 109 Attachm ent 4: Chronic Wate r Only Results File US EPA Ver. 3
. 16, 03-08

- d DEEM

- FCID Chronic ana l ysis for ISOF E TAMID NHANES 2003-2008 2-day Residue file name: C:\Users \ ndodd\Documents\DEEM Ve r sion 3.16\Isofetamid 2014\isofetamid chronic water only 091914.R08 Adjustment factor #2 used. Analysis Date 09-19

- 2014/11:44:3 1 Residue file d a ted: 09-19-201 4 / 11 :37:47 R

e f e rence dose ( Rf D , Chronic) 

### = .77 mg/ k g bw/day ==========••=================•=================== ====== ====a= • === === ==== == ===== To tal exposure b y population subg roup

Population

Subgroup Total us Popu l a t i on H

ispanic N

o n -Hisp-White Non-Hisp

- Black Non

- Hisp

- Other Nurs i ng Infants Non-Nursing Infant s Female 13+ PREG Children 1-6 Ch ildren 7

- 12 Mal e 13

- 19 Fe male 13

- 19/NP M

a le 20+ Female 20+/NP Seniors 55+ All Infants Female 13

- 50 Ch ildren 1-2 Ch ildr en 3

- 5 Ch ildren 6-12 Y

o uth 13-19 Adults 20-49 Adults 50

- 99 Female 13-49 Total Exposure mg/kg Percent of body wt/day R f d



### ------------- 

### -- - - --- -- - - --- - - 0.00230 3 0
. 3% 0.00219 9 0. 3% 0.002369 0
. 3% 0.00 1 901 0
. 2% 0.002655 0 .H 0.002084 0 .3t 0.00766 1 l.Ot 0.002 1 69 0
. 3\- 0.002950 0
. 4\ 0.0019 2 0 0 .2 % 0.00 1 583 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% 0.0 0 2799 0
. 4% 0 .002 0 1 9 0
. 3% 0.001680 0
. 2'1; 0.002298 0
. 3\ 0. 002272 0
. 3\' 0.002290 0. 3%

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