  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDES

                                                                                AND TOXIC SUBSTANCES

MEMORANDUM

Date:  		July 3, 2008

SUBJECT:	Ethoprop. Acute (Probabilistic), Chronic, and Cancer Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for Proposed New Uses on Hops and Mint

PC Code:  041101	DP Barcode:   352232 and 352234

Decision No.: 382076, 299884	Registration No.: N/A

Petition No.: 5E4491 and 7E7247	Regulatory Action: New Registration/Tolerance

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

TXR No.: N/A	CAS No.: 13194-48-4

MRID No.: N/A	40 CFR:  180.262

FROM:	Christine L. Olinger, Chemist

Reregistration Branch 1

Health Effects Division (7509P)

THROUGH:	David Hrdy, Sr. Biologist

Sheila Piper, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

		Toiya Goodlow, Chemist

Michael S. Metzger, Branch Chief

Reregistration Branch 1

Health Effects Division (7509P)

TO:		Kit Farwell, D.V.M.

		Reregistration Branch 1

		Health Effects Division (7509P)

and

Susan Stanton

Risk Integration, Minor Use & Emergency Response Branch

Registration Division (7505P)

Executive Summary

ID™, Version 2.03, which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support Section 3 requests for new uses on hops and mint.  The acute, chronic, and cancer assessments are somewhat refined, incorporating usage data for most crops and PDP monitoring data for many of the existing uses.  Analyses were conducted using water modeling and monitoring data.

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

The dietary exposure from food alone for the most highly exposed subgroup, all infants, is at 18% of the acute population adjusted dose (aPAD). When using the surface water modeled estimate in the acute analysis the risk exceeds the level of concern, with the exposure estimates at 920% of the aPAD for the most highly exposed sub-group, infants, at the 99.9th percentile of exposure.  When using the highest concentration from the targeted surface water monitoring study of raw (before treatment) water, the combined food and water estimates are well below the level of concern, with the exposure estimates at 18% of the aPAD for the most highly exposed sub-group, infants.  Acute dietary risks are at 99% for the most highly exposed sub-group, all infants, when water concentrations are 65 times the maximum water concentration found in the targeted surface water monitoring study.

Chronic Dietary (Drinking Water) Exposure Results and Characterization

All exposure estimates are below the level of concern for chronic exposures. The dietary exposure from food alone for the most highly exposed subgroup, children aged 1-2, is at 2.2% of the chronic population adjusted dose (cPAD). When the estimated drinking water concentration (EDWC) from the surface water model is used to represent water exposure the most highly exposed population sub-group is all infants, with the total food and water exposure at 90% of the chronic population adjusted dose (cPAD).  This is an overestimate of exposure, since water monitoring data indicate much lower water concentrations.

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

The cancer risk from food alone for the US population is 3 x 10-7. The cancer risk is 4 x 10-7, which is well below the level of concern, when the maximum water concentration observed in a targeted monitoring study is used in the assessment.  Even at water concentrations twenty times the maximum observed in the targeted study the risk is below the level of concern.  Generally, HED does not use maxima in a cancer assessment, but typically concentrations averaged over a lifetime of exposure are used.  When using the maximum modeled EDWC for a lifetime of exposure, the ground water value estimated using SCI-GROW, the cancer risk exceeds the level of concern at 6 x 10-6.

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 which HED 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 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 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which 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:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (8/20/-1999).

The most recent dietary risk assessment for ethoprop was conducted by Christina Swartz (7/21/1999, D257828).

II.	Residue Information

Tolerances are currently established for numerous commodities in 40 CFR 180.262 for residues of the parent only and are listed in Table 1.  The registrant has proposed uses on hops and mint and is proposing tolerances be established in association with these uses at 0.02 ppm.  The residue data have been reviewed and found acceptable (Olinger and Fort, DP Barcodes: 352231 and 352233, 5/12/2008).  Although a tolerance for peanuts has been established, the registrant has voluntarily withdrawn all uses in association with the RED, and the Agency proposed to revoke the peanut tolerance in a recent Federal Register Notice (6/4/08 Volume 73, Number 108, pp. 31788-31807).

Table 1.  Tolerance Levels for Residues of Ethoprop

Commodity	Tolerance Level, ppm

Banana	0.02

Bean, lima	0.02

Bean, snap, succulent	0.02

Cabbage	0.02

Corn, forage	0.02

Corn, grain	0.02

Corn, stover	0.02

Corn, sweet, kernel plus cob with husks removed	0.02

Cucumber	0.02

Peanut 	0.02

Peanut, hay 	0.02

Pineapple	0.02

Potato	0.02

Sugarcane, cane	0.02

Sweet potato, roots	0.02

The residues of concern for the acute and chronic risk assessments in food and water are the parent and Metabolites II and III (S-ME and O-ME); for cancer dietary risk, the residues of concern are parent and Metabolites II through IV (S-ME, O-ME and M-1).   Since field trial and PDP data on the metabolites are not available, metabolite ratios were estimated from metabolism and rotational crop studies.  Further information on the development of the ratios may be found in the anticipated residue memo currently under review (C. Olinger, DP Barcodes 352476 and 352477).

Anticipated residues estimates were revised to incorporate recent PDP data.  A detailed description may be found in a separate document currently under review (C. Olinger, DP Barcodes 352476 and 352477).  PDP monitoring data are available for bananas, snap beans (fresh and canned), corn syrup, sweet corn (canned), cucumber, pineapple, potato, and sweet potato.  Residues were non-detectable for all commodities with the exception of bananas (six detects), fresh snap beans (one detect), and sweet potatoes (four detects).  Only the parent compound was monitored by PDP; metabolite data are not available, so metabolite ratios were applied to the PDP data.  Field trial data were used for field corn, mint, hops, lima beans, and cabbage.  Residues in most samples are non-detectable and any residues present are generally very low.

DEEM 7.81 default processing factors were used for dried bananas (plantains), dried pineapples, and dried potatoes.

The anticipated residues incorporate percent crop treated information for all crops except hops, mint, bananas, pineapple, and lima beans.  The percent crop treated estimates are from the Screening Level Usage Analysis (SLUA) dated 2/14/08 and are all generally 5% or less, with the exception of sweet potatoes with an estimated maximum at 15%.

Residue distribution files (RDF) were generated for bananas, snap beans, lima beans (succulent), cabbage, cucumbers, sweet potatoes, potatoes, sweet corn, corn syrup, and pineapple.  Water values and blended commodities were incorporated into the acute analysis as a point estimate.

The values used in the assessment, as well as the percent crop treated estimates, are included as attachments to this memo.

 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: “Ethoprophos Drinking Water Assessment; Including Evaluation of Submitted Ground and Surface Water Monitoring Studies (Revised from 6/28/07 assessment)” (M. Barrett, DP Barcodes 323344; 335734; 295045; 29503, 12/18/2007) 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.”   Three values were used for each dietary risk assessment:  1) the highest modeled value; 2) the sum of the highest value for each analyte from the targeted raw surface water monitoring; and 3) a value approximately twice the sum described in item 2.  These values are summarized in Table 2 below.  The model and its description are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

Table 2.  Summary of Water Concentrations Used in Dietary Assessments

Dietary Assessment	Water Concentration, ppb	Characterization

Acute	138	LA Sugarcane Scenario from PRZM-EXAMS; 0.87 crop area; upper 1-in-10 year peak concentration

Chronic	18	LA Sugarcane Scenario from PRZM-EXAMS; 0.87 crop area; upper 1-in-10 year annual mean concentration

Cancer	10.1	Sci-Grow Model

Acute, Chronic, and Cancer	0.231	Sum of:

Ethoprop max detect 14 ppt

SME 1 max detect 202 ppt

OME Method Detection Limit (MDL) 6 ppt

OHE MDL 7 ppt

SSDP MDL 2 ppt;

From surface water monitoring study of RAW water.

Acute, Chronic, and Cancer	0.52	Approximately twice the highest values from the monitoring data

1 SME = O-ethyl-S-methyl-S-propylphosphorodithioate; OME = O-ethyl-O-methyl-S-propylphosphorothioate; OHE = O-ethyl-S-propylphosphorothioate (M1 metabolite); SSDP = S,S-dipropylphosphorodithioate

EFED has characterized the modeled estimates has likely to be overestimates of exposure, particularly since it was assumed a large portion of the watershed was treated, but actual usage estimates are considerably lower.

A surface water monitoring study was required in the IRED, which generally shows much lower residues that modeled values from raw water.  Only a limited number of finished water samples were analyzed, but there were no detections in those samples that were analyzed.  EFED has expressed concern that the monitoring data may not sampled at an interval that would have caught the peak concentration; therefore, for characterization HED conducted dietary analyses at approximately twice the maximum concentration.  In addition, HED conducted additional analyses for the acute and cancer assessments to determine the maximum water concentration so that the aggregate food and water exposure would not exceed the level of concern.  EFED did not provide a distribution of water values for the Louisiana sugarcane scenario, the scenario leading to the highest acute modeled water values, because the PRZM/EXAMS sugarcane scenario is not currently set up to allow for the current sugarcane label recommendations, application once every 3 or 4 years instead of once every year.  PDP a慮祬敺㈳㠴眠瑡牥猠浡汰獥映潲桴敹牡⁳〲㄰ ㈭〰‵潦⁲瑥潨牰灯瀠牥猠ⱥ愠摮琠敨敲眠牥潮搠瑥 捥楴湯⁳瑡䰠䑏⁳慲杮湩牦浯㌠琠㜱瀠牡獴瀠牥琠 楲汬潩瀨瑰⸩഍

IV.	DEEM-FCID™ Program and Consumption Information

Ethoprop acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™, Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals 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 data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII 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 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (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 mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

Dietary endpoints for acute and chronic (non-cancer) exposures were based on plasma cholinesterase inhibition (CheI) in the most recent dietary assessments.  The risk assessment team has reevaluated the toxicology database and selected new endpoints based on brain cholinesterase inhibition, and based the points of departure on benchmark dose analyses (BMD).  Developmental neurotoxicity and comparative cholinesterase studies have been received and reviewed by the Agency.  There are no residual uncertainties regarding ethoprop exposure and hazard, so the FQPA safety factor has been reduced to 1x.

The HED Cancer Assessment Peer Review Committee (10/2/97 document) classified ethoprop as a "likely" human carcinogen due to the occurrence of malignant adrenal pheochromocytomas in male Sprague-Dawley rats. This classification was supported by the occurrence of thyroid C-cell adenomas and/or carcinomas in three different rat studies and evidence of clastogenicity by in vitro mutagenicity testing. The Q1* for ethoprop is 2.81 x10-2 mg/kg/day-1 (Hugh M. Pettigrew memo, 1/15/98).  Ethoprop was re-evaluated by the HED Cancer Assessment Review Committee because of new historical control data and arguments against ethoprop's cancer classification submitted by the registrant (Jess Rowland and Kit Farwell memo, 10/7/98). The committee retained the classification of ethoprop as a "likely" human carcinogen and recommended that adrenal slides in the low- and mid-dose groups be examined before the cancer classification would be reevaluated. These slides have not yet been examined by the registrant.

Table 3. Summary of Toxicological Doses and Endpoints for Ethoprop for Use in Dietary Risk Assessments

Exposure Scenario	Point of Departure	Uncertainty/FQPA Safety Factors RfD, PAD 	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children) BMDL10  = 0.76 mg/kg	UFA= 10x

UFH = 10x

FQPA SF= 1x	Acute RfD = 0.0076 mg/kg/day

aPAD = 0.0076 mg/kg/day	BMDL10  = 0.76 mg/kg based on brain ChEI in pups in the acute comparative cholinesterase study in rats.

Acute Dietary

(Females 13-49 years of age)	There is no increased susceptibility for females of child-bearing age.

The aPAD for the general population is protective of this population group.

Chronic Dietary (All Populations)	BMDL10  = 0.14 mg/kg/day	UFA= 10x

UFH = 10x

FQPA SF= 1x	Chronic RfD = 0.0014

mg/kg/day

cPAD = 0.0014 mg/kg/day	BMDL10  = 0.14 mg/kg/day based on brain ChEI in pups in the repeated dose comparative cholinesterase study in rats.

Cancer (oral route of exposure)	Classification:  "Likely to be carcinogenic to humans."

Q1* = 2.81 x 10-2 based on malignant adrenal pheochromocytomas in male rats.

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.   BMDL10  = lower 95% confidence limit of the 10% benchmark response, in this case the estimated dose resulting in 10% ChEI.  ChEI = cholinesterase inhibition.  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.  RfD = reference dose (PoD ( combined UF).  PAD = population adjusted dose (RfD ( FQPA SF; a = acute;  c = chronic).

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Tables 4, 5, and 6 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+ years.  Cancer risk is determined for the general U.S. population only.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The results of the acute dietary exposure analysis 99.9th percentiles of exposure are reported in Table 4 for food alone and aggregate food and water, at various water concentrations.  When the PRZM-EXAMS modeled value is used for the drinking water concentration the risk exceeds the level of concern at the 95th, 99th, and the 99.9th percentiles of exposure.  However, if the highest surface water monitoring value (0.231 ppb) is used as well as the value twice that (0.52 ppb), exposures are well below the level of concern.  The highest exposed population sub-group is infants at 22% of the aPAD for when either 0.231 or 0.52 ppb is used for the estimated drinking water concentration (EDWC) at the 99.9th percentile of exposure.  Infants are also the highest exposed population when the highest modeled value (138 ppb) is used, with exposure at 920% aPAD.  HED conducted various scoping analyses to determine the water concentration at which the total food and water exposure is less than 100% of the aPAD.  For infants at the 99.9th percentile of exposure, and using an EDWC the 15 ppb, the total food and water exposure is at 99% of the aPAD.

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

The results of the aggregate chronic dietary exposure analysis are reported in Table 5 below.  All exposure estimates are below the level of concern for all population groups, using all estimated drinking water concentrations.  The maximum drinking water value used, the modeled estimate (18 ppb), is likely an overestimate because it assumes that most of the watershed is treated.

Table 4.  Results of Ethoprop Acute Dietary (Food and Drinking Water) Exposure Analysis Using DEEM FCID

Population Subgroup	aPAD (mg/kg/day)	Food Alone	Food and Drinking Water Using 138 ppb Water Value	Food and Drinking Water Using 0.231 ppb Water Value	Food and Drinking Water Using 0.52 ppb Water Value	Food and Drinking Water Using 15 ppb Water Value

99.9th Percentile	99.9th Percentile	99.9th Percentile	99.9th Percentile 99.9th Percentile

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

General U.S. Population	0.0076	0.000668	8.8	0.0272	360	0.000673	8.9 0.000684	9.0	0.003	39

All Infants (< 1 year old)	0.0076	0.0014	18	0.0697	920	0.00141	18 0.00142	19	0.00753	99

Children 1-2 years old	0.0076	0.00127	17	0.0273	360	0.00127	17	0.00127 17	0.0031	41

Children 3-5 years old	0.0076	0.00103	14	0.0268	350	0.00105	14	0.00107 14	0.00304	40

Children 6-12 years old	0.0076	0.000632	8.3	0.0163	210	0.000608	8.0 0.000627	8.2	0.00188	25

Youth 13-19 years old	0.0076	0.000339	4.5	0.0178	230	0.000348	4.6 0.000353	4.6	0.002	26

Adults 20-49 years old	0.0076	0.00035	5.7	0.0203	270	0.000436	5.7 0.000441	5.8	0.0022	29

Adults 50+ years old	0.0076	0.000436	6.1	0.00141	180	0.000467	6.1 0.000472	6.2	0.00155	20

Females 13-49 years old 	0.0076	0.000426	5.6	0.0192	250	0.000434	5.7 0.000439	5.8	0.00209	28

Note:  the bolded population(s) indicate the highest dietary exposure to ethoprop residues.

Table 5.  Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis Using  DEEM FCID

Population Subgroup	cPAD (mg/kg/day)	Food Alone	Food and Drinking Water Using 18 ppb Water Value	Food and Drinking Water Using 0.231 ppb Water Value	Food and Drinking Water Using 0.52 ppb Water Value

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

General U.S. Population	0.0014	0.000007	0.5	0.000387	28	0.000012	0.9 0.000018	1.3

All Infants (< 1 year old)	0.0014	0.000022	1.6	0.00127	90	0.000038	2.7 0.000058	4.2

Children 1-2 years old	0.0014	0.000031	2.2	0.000595	42	0.000038	2.7 0.000047	3.4

Children 3-5 years old	0.0014	0.000018	1.3	0.000545	39	0.000024	1.7 0.000033	2.3

Children 6-12 years old	0.0014	0.000008	0.6	0.000372	27	0.000013	0.9 0.000019	1.3

Youth 13-19 years old	0.0014	0.000003	0.2	0.000278	20	0.000007	0.5 0.000011	0.8

Adults 20-49 years old	0.0014	0.000005	0.3	0.000359	26	0.000009	0.7 0.000015	1.1

Adults 50+ years old	0.0014	0.000006	0.4	0.000379	27	0.000011	0.8 0.000017	1.2

Females 13-49 years old 	0.0014	0.000005	0.3	0.000357	26	0.000009	0.7 0.000015	1.1

Note:  the bolded population(s) indicate the highest dietary exposure to ethoprop residues.

Results of Cancer Dietary (Food and Drinking Water) Exposure Analysis

The estimated exposures of the general U.S. population to ethoprop as well as the corresponding cancer risk estimates are presented in Table 6.  HED conducted these analyses with varying levels of water concentrations.  Calculated risks ranging from approximately 3 x 10-7 to 3 x 10-6 are indistinguishable from 10-6.  Generally HED is concerned when the calculated risks exceed approximately 3 x 10-6.  The estimated risk for food alone is below the level of concern.  The combined risk for food and water is below the level of concern if the concentration of ethoprop in water (over a lifetime of exposure) is 5 ppb or lower.    The maximum water concentration observed in the target surface water monitoring study was 0.231 ppb.  If the maximum modeled estimate is used as the drinking water concentration the estimated cancer risk is 6 x 10-6, which exceeds the level of concern.  Water was the greatest contributor to the aggregate dietary exposure.  A commodity contribution analysis indicated that bananas and pineapple are the food commodities leading to the greatest exposure to ethoprop in food.

Table 6.  Results of Cancer Dietary (Food and Drinking Water) Exposure Analysis Using  DEEM FCID at Varying Water Concentrations

Scenario	Exposure, mg/kg/day	Estimated Cancer Risk

Food Alone	0.000009	3 x 10-7

Food and Drinking Water Using 10.1 ppb Water Value	0.00022	6 x 10-6

Food and Drinking Water Using 0.231 ppb Water Value	0.000014	4 x 10-7

Food and Drinking Water Using 0.52 ppb Water Value	0.000020	6 x 10-7

Food and Drinking Water Using 5 ppb Water Value	0.000115	3 x 10-6

VII.	Characterization of Inputs/Outputs

The exposure assessments were refined as monitoring data was used when available and usage data were incorporated for most commodities.  Following is a description of the refinements used and the uncertainties associated with each.

Since residue data were not available for some metabolites of concern, and the monitoring data did not include analyses of any metabolites, metabolite ratios were estimated from the metabolism and rotational crop studies.  The maximum ratio from any commodity was used for the acute analyses, which probably overestimated the metabolite concentrations in the acute analysis.  If a metabolism study was available for the same or highly similar crop, then that ratio was used.  Any potential uncertainty over the metabolite ratios and possible concern for underestimation of metabolite residues is outweighed by the overestimates of residue levels and usage.

Field trial and/or tolerance level residues were used for several commodities where monitoring data were not available or for the new uses on hops and mint.  Residues in general are non-detectable or very low.  Considering the very low rate of detectable residues in the monitoring data, the use of field trial and tolerance-level residue likely overestimates exposure to ethoprop and its metabolites.

USDA PDP monitoring data were used for several commodities.  For most commodities residues were non-detectable in all samples; the few detectable residues were very low, generally less than 0.01 ppm.

Usage information was available for most commodities.  However, it was assumed that all of the following crops were treated:  bananas, pineapples, lima beans, hops, and mint.   The 100% crop treated assumption is probably an overestimate, so the exposure estimates are likely to be overestimated as well.

Default processing factors were used when empirical data were not available.

The dietary exposures were estimated using a range of estimated drinking water concentrations to further characterize exposure.  EFED has characterized the modeled values as likely overestimates, particularly because of the high percent crop area values used.  Targeted surface water monitoring studies show considerably lower water concentrations than modeled values.  However, EFED has requested further information to ensure that the sites selected represent the areas of highest ethoprop usage.  HED has provided the range of risks associated with various water concentrations to assist in the risk management decision.

For the cancer assessment, water is the greatest contributor to the dietary exposure to ethoprop.  The food commodity that contributes to the most exposure is banana.  The assumption of 100% crop treated for this commodity, as well as generally high consumption of bananas, are the likely causes for this commodity to be the greatest contributor to the exposure to ethoprop in food.

VIII.	Conclusions

Acute, chronic, and cancer dietary exposure and risk assessments were conducted to support the proposed new uses of ethoprop on mint and hops.  The assessments were somewhat refined, incorporating usage data for most crops and PDP monitoring data for many of the existing uses. Analyses were conducted using water modeling and monitoring data.  When using the surface water modeled estimate in the acute analysis the risk exceeds the level of concern, with the exposure estimates at 920% of the aPAD for the most highly exposed sub-group, infants, at the 99.9th percentile of exposure.  When using the highest concentration from the targeted surface water monitoring study of raw (before treatment) water, the combined food and water estimates are well below the level of concern, with the exposure estimates at 18% of the aPAD for the most highly exposed sub-group, infants.  Acute dietary risks are at 99% of the most highly exposed sub-group when water concentrations are 65 times the maximum water concentration found in the targeted surface water monitoring study.  All exposure estimates are below the level of concern for chronic exposures.  When the EDWC from the surface water model is used to represent water exposure the most highly exposed population sub-group is infants, with the total food and water exposure at 90% of the cPAD.  This is an overestimate of exposure, since water monitoring data indicate much lower water concentrations.  The cancer risk is 4 x 10-7, which is well below the level of concern, when the maximum water concentration observed in a targeted monitoring study is used in the assessment.  Even at water concentrations twenty times the maximum observed in the targeted study the risk is below the level of concern.  Generally, HED does not use maxima in a cancer assessment, but typically concentrations averaged over a lifetime of exposure are used.  When using the maximum modeled EDWC, the ground water value estimated using SCI-GROW, the cancer risk exceeds the level of concern at 6 x 10-6.

IX.		List of Attachments

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

Attachment 2.  Residue Distribution Files.

Attachment 3.  Percent Crop Treated Memo from BEAD.

Attachment 4.  Acute Food Only Residue Input File

Attachment 5.  Chronic Food Only Residue Input File

Attachment 6.  Cancer Food Only Residue Input File

Attachment 7.  Acute Food plus Water Results file.  Water at 138 ppb.

Attachment 8.  Acute Food plus Water Results file.  Water at 15 ppb.

Attachment 9.  Acute Food plus Water Results file.  Water at 231 ppt.

Attachment 10.  Acute Food plus Water Results file.  Water at 520 ppt.

Attachment 11.  Acute Food only Results file.

Attachment 12.  Chronic Food plus Water Results file.  Water at 18 ppb.

Attachment 13.  Chronic Food plus Water Results file.  Water at 231 ppt.

Attachment 14.  Chronic Food plus Water Results file.  Water at 520 ppt.

Attachment 15.	Chronic Food only Results file.

Attachment 16.  Cancer Food plus Water Results file.  Water at 10.1 ppb.

Attachment 17.  Cancer Food plus Water Results file.  Water at 5 ppb.

Attachment 18.  Cancer Food plus Water Results file.  Water at 231 ppt.

Attachment 19.  Cancer Food plus Water Results file.  Water at 520 ppt.

Attachment 20.  Cancer Food only Results file.

Attachment 21.  Chronic Critical Commodity Contribution Analyses.  Water at 18 ppb.

Attachment 22.  Cancer Critical Commodity Contribution Analyses.  Water at 10.1 ppb.

cc:	COlinger

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

Summary of Anticipated Residues used in Ethoprop Dietary Assessment

	Residue Source 1	Classifi-cation 2	Est.  Max %CT 3	Wtd. Avg. %CT 3 Acute	Chronic/ Cancer

Residue Value	Chronic	Cancer

Metab. Ratio 4	Anticipated Residue (AR), ppm 5

Metab. Ratio	AR6	Metab. Ratio	AR6	Comment

Commodities with Currently Established Tolerances

Banana	PDP	NB/PB	100	100	6	Bananas.rdf	0.0048	2.7	0.01296	3.3	0.01584 avg of all PDP detects and 1/2 LODs

Bean, lima, dried	Tol	B	100	100	6	0.02/0.12	0.02	2.7	0.054	3.3	0.066

	Bean, lima, succulent	Tol	PB	100	100	6	Beanslimasucculent.rdf	0.02	2.7 0.054	3.3	0.066

	Bean, snap, succulent	PDP	PB	5	5	6	Beanssnap.RDF	0.001	2.7	0.0027	3.3 0.0033	avg of all PDP detects and 1/2 LODs

Bean, snap, succulent, canned	PDP	PB	5	5	6	cannedsnapBeans.RDF	0.001	2.7 0.0027	3.3	0.0033	1/2  LOD

Cabbage	FT	NB/PB	5	5	1.8	Cabbage.rdf	0.0176	1.8	0.033	2.2	0.0404	used 1/2 LOQ for non-detects

Corn, grain, field, syrup	PDP	B	2.5	1	6	cornsyrup.rdf	0.0015	2.7	0.00405 3.3	0.00495	1/2 LOD

Corn, grain, field	FT	B	2.5	1	6	0.005/0.00075	0.005	2.7	0.0135	3.3 0.0165	1/2 LOD

Corn, sweet, fresh	FT	NB/PB	5	1	6	cornsweet.rdf	0.005	2.7	0.0135	3.3 0.0165	1/2 LOD

Cucumber	PDP	NB	5	1	6	cucumber.rdf	0.0029	2.7	0.00783	3.3	0.00957	1/2 average LOD

Pineapple	PDP	NB	100	100	6	pineapple.rdf	0.0038	2.7	0.01026	3.3	0.01254 Average of 1/2 LODs

Potato	PDP	NB/PB	5	5	1.1	potato.rdf	0.006	1.1	0.0066	3.8	0.0228	Average of 1/2 LODs

Potato (blended commodities)	PDP	B	5	5	1.1	0.006/0.00033	0.006	1.1 0.0066	3.8	0.0228	Average of 1/2 LODs

Sugarcane, cane	FT	B	5	5	6	0.005/0.0015	0.005	2.7	0.0135	3.3	0.0165	1/2 LOD

Sweet potato, roots	PDP	NB	15	15	1.1	sweetpotato.rdf	0.002	1.1	0.0022 3.8	0.0076	Avg.of Detects and 1/2 LODs

Commodities with New Tolerances Proposed

Mint	Tol	B	100	100	6	0.02/0.12	0.02	2.7	0.054	3.3	0.066

	Hops	Tol	B	100	100	6	0.02/0.12	0.02	2.7	0.054	3.3	0.066

1 FT = Field Trial; PDP = USDA Pesticide Data Program; Tol = existing or proposed tolerance.

2 Classification of blended (B), partially blended (PB), not blended (NB).  3 Percent crop treated estimates were obtained from the SLUA dated 2/14/08.

4 Metabolite ratios were obtained from metabolism and confined rotational crop studies are needed to account for all residues of risk concern.

5 Name of RDF is included; values may be found in following table.  For blended commodities the residue value and the anticipated residue are provided.  The acute anticipated residue is the product of the percent crop treated, metabolite ratio, and residue value.

6 The chronic and cancer anticipated residue is the product of the metabolite ratio and residue value.Attachment 2. Residue Distribution Files

Bananas.rdf

Banana PDP

100%CT

Totalfreq=2

TotalNZ=6

833,0.09

590,0.012

0.15

0.078

0.072

0.042

0.018

0.018	Beanslimasucculent.rdf

Lima Bean 100%CT Tol

TOTALZ=0

TOTALLOD=1

LODRES=0.12	Snap Bean, Fresh, 5%CT PDP

totalNZ=1

TOTALZ=1509

Totalfreq=1

79, 0.006

0.012

cannedsnapBeans.RDF

Snap Bean 5%CT PDP

TOTALZ=19

TOTALLOD=1

LODRES=0.006	Cabbage.rdf

Cabbage FT  5%CT

totalNZ=3

TOTALZ=171

Totalfreq=1

6, 0.018

0.0846

0.0738

0.0288	cornsyrup.rdf

CornSyrup 2.5%CTPDP

TOTALZ=0

TOTALLOD=438

LODRES=0.009

cornsweet.rdf

sweetcorn 5%CT FT

TOTALZ=19

TOTALLOD=1

LODRES=0.03	cucumber.rdf

cucumber 5%CT PDP

TOTALZ=2261

TOTALLOD=119

LODRES=0.045	pineapple.rdf

Pineapple 100%CT PDP

TOTALZ=0

TOTALLOD=1454

LODRES=0.03

potato.rdf

Potato 5%CT PDP

TOTALZ=1398

TOTALLOD=74

LODRES=0.0088	sweetpotato.rdf

Sweet Potato 15%CT PDP

TOTALZ=1255

TOTALNZ=4

Totalfreq=1

218,0.0022

0.00737

0.0033

0.0022

0.0022

Attachment 3.  Ethoprop SLUA

ETHOPROP  041101

Screening Level Usage Analysis (SLUA)

February 14, 2008

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

Pesticide usage data obtained from various sources.  The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used on.

Available pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.

Annual percent of crop treated (average & maximum) for each agricultural crop.

Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by merging pesticide usage data sources together; averaging across all observations, then rounding.  Note:  If the estimated value is less than 500, then that value is labeled <500.  Estimated values between 500 & <1,000,000 are rounded to 1 significant digit.  Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5.  Note:  If the estimated value is less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National Agricultural Statistics Service) – pesticide usage data from 2001 to 2006.

Private pesticide market research – pesticide usage data from 2001 to 2006.

NPUD 2002 (National Pesticide Use Database) pesticide usage data from NPUD 02 of the CropLife Foundation are used only if data are not available from the other sources.

California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 2000 to 2005 when 95% or more of a crop is grown California.

What are the limitations to the data?

Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply zero usage.

Usage data on a particular site may be noted in data sources, but not quantified.  In these instances, the site would not be reported in the SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not reported in the SLUA.  A separate request must be made to receive these estimates.

Some sites show some use, even though they are not on the label.  This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs).

February 14, 2008

Screening Level Estimates of Agricultural Uses of ETHOPROP  041101

Sorted Alphabetically

                           Crop	                                     Lbs.A.I.                                            Percent Crop Tt.

                                                                                Avg.           Max.

	1 	Beans, Green	40,000	                                                5                 5

	2 	Cabbage	                                     5,000                                                5                 5

	3 	Chicory* +	<500	                                            N/C            N/C

	4 	Corn	30,000	                                              <1            <2.5

	5 	Cucumbers	5,000	                                              <1                 5

	6 	Onions +	5,000	                                              <1            <2.5

	7 	Peanuts	7,000	                                              <1            <2.5

	8 	Potatoes	200,000	                                                5                 5

	9 	Pumpkins +	<500	                                              <1            <2.5

	10	Squash +	<500	                                              <1            <2.5

	11	Sugarcane	100,000	                                                5                 5

	12	Sweet Corn	10,000	                                              <1                 5

	13	Sweet Potatoes (NPUD'02)	50,000	                                            N/C               15

	14	Tobacco	30,000	                                               <1            <2.5

______________________________________

All numbers rounded.

'<500'  indicates less than 500 pounds of active ingredient.

'<2.5'   indicates less than 2.5 percent of crop is treated.

'<1'	indicates less than 1 percent of crop is treated.

   * CA data only, but 95% or more of U.S. acres are in California

SLUA data sources include:

	USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service)-

            2001-2006

	Private Pesticide Market Research-2001-2006

	NPUD 2002 (National Pesticide Use Database) of the CropLife America Foundation

	California DPR data 2004-2006

	These results reflect amalgamated data developed by the Agency and are releasable to the public.

N/C = Not Calculated

+ = These crops were not listed as active product registrations when this report was run.

Attachment 4.  Acute Food Only Residue Input File.

Filename: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethopropacuterefinedARShopsandmintfoodonly.R98

Chemical: Ethoprop

RfD(Chronic): .0014 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .0076 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0281

Date created/last modified: 06-03-2008/09:45:57/8          Program ver. 2.03

Comment: Pup Brain 8 hour; food only

------------------------------------------------------------------------ --------

RDL indices and parameters for Monte Carlo Analysis:

Index Dist Parameter #1        Param #2  Param #3  Comment

  #   Code

----- ---- ------------        --------  --------  -------

  1    6   bananas.rdf

  2    6   limabeans.rdf

  3    6   beanssnap.rdf

  4    6   cabbage.rdf

  5    6   cornsweet.rdf

  6    6   cucumber.rdf

  8    6   pineapple.rdf

  9    6   potato.rdf

  10   6   sweetpotato.rdf

  11   6   cornsyrup.rdf

  12   6   cannedsnapbeans.rdf

  EPA    Crop Commodity Name                    Def Res     Adj.Factors  RDL  Comment

  Code    Grp                                    (ppm)       #1     #2   Pntr

-------- ---- -------------------------------  ----------  ------ ------ ---  -------

95000230 O    Banana                             0.150000   1.000  1.000   1

95000231 O    Banana-babyfood                    0.150000   1.000  1.000   1

95000240 O    Banana, dried                      0.150000   3.900  1.000   1

95000241 O    Banana, dried-babyfood             0.150000   3.900  1.000   1

06020370 6B   Bean, lima, succulent              0.120000   1.000  1.000   2

06030380 6C   Bean, lima, seed                   0.120000   1.000  1.000

06010430 6A   Bean, snap, succulent

                 110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.006000   1.000  1.000   3

                 210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.006000   1.000  1.000   3

                 211-Cooked; Fresh or N/S; Baked

                                                 0.006000   1.000  1.000   3

                 212-Cooked; Fresh or N/S; Boiled

                                                 0.006000   1.000  1.000   3

                 213-Cooked; Fresh or N/S; Fried

                                                 0.006000   1.000  1.000   3

                 215-Cooked; Fresh or N/S; Boiled/baked

                                                 0.006000   1.000  1.000   3

                 221-Cooked; Frozen; Baked       0.006000   1.000  1.000   3

                 222-Cooked; Frozen; Boiled      0.006000   1.000  1.000   3

                 232-Cooked; Dried; Boiled       0.006000   1.000  1.000   3

                 240-Cooked; Canned; Cook Meth N/S

                                                 0.006000   1.000  1.000  12

                 242-Cooked; Canned; Boiled      0.006000   1.000  1.000  12

06010431 6A   Bean, snap, succulent-babyfood     0.006000   1.000  1.000  12

05010690 5A   Cabbage                            0.030000   1.000  1.000   4

05020700 5B   Cabbage, Chinese, bok choy         0.030000   1.000  1.000   4

05010710 5A   Cabbage, Chinese, napa             0.030000   1.000  1.000   4

05010720 5A   Cabbage, Chinese, mustard          0.030000   1.000  1.000   4

15001200 15   Corn, field, flour                 0.000750   1.000  1.000

15001201 15   Corn, field, flour-babyfood        0.000750   1.000  1.000

15001210 15   Corn, field, meal                  0.000750   1.000  1.000

15001211 15   Corn, field, meal-babyfood         0.000750   1.000  1.000

15001220 15   Corn, field, bran                  0.000750   1.000  1.000

15001230 15   Corn, field, starch                0.000750   1.000  1.000

15001231 15   Corn, field, starch-babyfood       0.000750   1.000  1.000

15001240 15   Corn, field, syrup                 0.000750   1.000  1.000  11

15001241 15   Corn, field, syrup-babyfood        0.000750   1.000  1.000  11

15001250 15   Corn, field, oil                   0.000750   1.000  1.000

15001251 15   Corn, field, oil-babyfood          0.000750   1.000  1.000

15001260 15   Corn, pop                          0.000750   1.000  1.000

15001270 15   Corn, sweet                        0.030000   1.000  1.000   5

15001271 15   Corn, sweet-babyfood               0.030000   1.000  1.000   5

09021350 9B   Cucumber                           0.030000   1.000  1.000   6

95001880 O    Hop                                0.120000   1.000  1.000

95002750 O    Peppermint                         0.120000   1.000  1.000

95002760 O    Peppermint, oil                    0.120000   1.000  1.000

95002790 O    Pineapple                          0.030000   1.000  1.000   8

95002791 O    Pineapple-babyfood                 0.030000   1.000  1.000   8

95002800 O    Pineapple, dried                   0.030000   5.000  1.000   8

95002810 O    Pineapple, juice                   0.030000   1.000  1.000   8

95002811 O    Pineapple, juice-babyfood          0.030000   1.000  1.000   8

95002830 O    Plantain                           0.150000   1.000  1.000   1

95002840 O    Plantain, dried                    0.150000   3.900  1.000   1

01032960 1C   Potato, chips                      0.000330   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.000330   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.000330   6.500  1.000

01032980 1C   Potato, flour                      0.000330   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.000330   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.005500   1.000  1.000   9

01032991 1C   Potato, tuber, w/peel-babyfood     0.005500   1.000  1.000   9

01033000 1C   Potato, tuber, w/o peel            0.005500   1.000  1.000   9

01033001 1C   Potato, tuber, w/o peel-babyfood   0.005500   1.000  1.000

95003520 O    Spearmint                          0.120000   1.000  1.000

95003530 O    Spearmint, oil                     0.120000   1.000  1.000

95003620 O    Sugarcane, sugar                   0.001500   1.000  1.000

95003621 O    Sugarcane, sugar-babyfood          0.001500   1.000  1.000

95003630 O    Sugarcane, molasses                0.001500   1.000  1.000

95003631 O    Sugarcane, molasses-babyfood       0.001500   1.000  1.000

01033660 1CD  Sweet potato                       0.007370   1.000  1.000  10

01033661 1CD  Sweet potato-babyfood              0.007370   1.000  1.000  10

Attachment 5.  Chronic Food Only Residue Input File.

Filename: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprchronicefinedARShopsandmintfoodonly.R98

Chemical: Ethoprop

RfD(Chronic): .0014 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .0076 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0281

Date created/last modified: 06-10-2008/09:51:45/8          Program ver. 2.03

Comment: Chronic BMD10 = 0.0014;  food only

------------------------------------------------------------------------ --------

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

-------- ---- -------------------------------  ----------  ------ ------  -------

95000230 O    Banana                             0.013000   1.000  1.000

95000231 O    Banana-babyfood                    0.013000   1.000  1.000

95000240 O    Banana, dried                      0.013000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.013000   3.900  1.000

06020370 6B   Bean, lima, succulent              0.054000   1.000  0.050

06030380 6C   Bean, lima, seed                   0.054000   1.000  0.050

06010430 6A   Bean, snap, succulent              0.002700   1.000  0.050

06010431 6A   Bean, snap, succulent-babyfood     0.002700   1.000  0.050

05010690 5A   Cabbage                            0.033000   1.000  0.050

05020700 5B   Cabbage, Chinese, bok choy         0.033000   1.000  0.050

05010710 5A   Cabbage, Chinese, napa             0.033000   1.000  0.050

05010720 5A   Cabbage, Chinese, mustard          0.033000   1.000  0.050

15001200 15   Corn, field, flour                 0.013500   1.000  0.010

15001201 15   Corn, field, flour-babyfood        0.013500   1.000  0.010

15001210 15   Corn, field, meal                  0.013500   1.000  0.010

15001211 15   Corn, field, meal-babyfood         0.013500   1.000  0.010

15001220 15   Corn, field, bran                  0.013500   1.000  0.010

15001230 15   Corn, field, starch                0.013500   1.000  0.010

15001231 15   Corn, field, starch-babyfood       0.013500   1.000  0.010

15001240 15   Corn, field, syrup                 0.004050   1.000  0.010

15001241 15   Corn, field, syrup-babyfood        0.004050   1.000  0.010

15001250 15   Corn, field, oil                   0.013500   1.000  0.010

15001251 15   Corn, field, oil-babyfood          0.013500   1.000  0.010

15001260 15   Corn, pop                          0.013500   1.000  0.010

15001270 15   Corn, sweet                        0.013500   1.000  0.010

15001271 15   Corn, sweet-babyfood               0.013500   1.000  0.010

09021350 9B   Cucumber                           0.007830   1.000  0.010

95001880 O    Hop                                0.054000   1.000  1.000

95002750 O    Peppermint                         0.054000   1.000  1.000

95002760 O    Peppermint, oil                    0.054000   1.000  1.000

95002790 O    Pineapple                          0.010300   1.000  1.000

95002791 O    Pineapple-babyfood                 0.010300   1.000  1.000

95002800 O    Pineapple, dried                   0.010300   5.000  1.000

95002810 O    Pineapple, juice                   0.010300   1.000  1.000

95002811 O    Pineapple, juice-babyfood          0.010300   1.000  1.000

95002830 O    Plantain                           0.013000   1.000  1.000

95002840 O    Plantain, dried                    0.013000   3.900  1.000

01032960 1C   Potato, chips                      0.006600   1.000  0.050

01032970 1C   Potato, dry (granules/ flakes)     0.006600   6.500  0.050

01032971 1C   Potato, dry (granules/ flakes)-b   0.006600   6.500  0.050

01032980 1C   Potato, flour                      0.006600   1.000  0.050

01032981 1C   Potato, flour-babyfood             0.006600   1.000  0.050

01032990 1C   Potato, tuber, w/peel              0.006600   1.000  0.050

01032991 1C   Potato, tuber, w/peel-babyfood     0.006600   1.000  0.050

01033000 1C   Potato, tuber, w/o peel            0.006600   1.000  0.050

01033001 1C   Potato, tuber, w/o peel-babyfood   0.006600   1.000  0.050

95003520 O    Spearmint                          0.054000   1.000  1.000

95003530 O    Spearmint, oil                     0.054000   1.000  1.000

95003620 O    Sugarcane, sugar                   0.013500   1.000  0.050

95003621 O    Sugarcane, sugar-babyfood          0.013500   1.000  0.050

95003630 O    Sugarcane, molasses                0.013500   1.000  0.050

95003631 O    Sugarcane, molasses-babyfood       0.013500   1.000  0.050

01033660 1CD  Sweet potato                       0.002200   1.000  0.150

01033661 1CD  Sweet potato-babyfood              0.002200   1.000  0.150

Attachment 6.  Cancer Food Only Residue Input File.

Filename: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintfoodonly.R98

Chemical: Ethoprop

RfD(Chronic): .0014 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .0076 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0281

Date created/last modified: 06-10-2008/09:41:18/8          Program ver. 2.03

Comment: Food only

------------------------------------------------------------------------ --------

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

-------- ---- -------------------------------  ----------  ------ ------  -------

95000230 O    Banana                             0.015800   1.000  1.000

95000231 O    Banana-babyfood                    0.015800   1.000  1.000

95000240 O    Banana, dried                      0.015800   3.900  1.000

95000241 O    Banana, dried-babyfood             0.015800   3.900  1.000

06020370 6B   Bean, lima, succulent              0.066000   1.000  0.050

06030380 6C   Bean, lima, seed                   0.066000   1.000  0.050

06010430 6A   Bean, snap, succulent              0.003300   1.000  0.050

06010431 6A   Bean, snap, succulent-babyfood     0.003300   1.000  0.050

05010690 5A   Cabbage                            0.040000   1.000  0.050

05020700 5B   Cabbage, Chinese, bok choy         0.040000   1.000  0.050

05010710 5A   Cabbage, Chinese, napa             0.040000   1.000  0.050

05010720 5A   Cabbage, Chinese, mustard          0.040000   1.000  0.050

15001200 15   Corn, field, flour                 0.016500   1.000  0.010

15001201 15   Corn, field, flour-babyfood        0.016500   1.000  0.010

15001210 15   Corn, field, meal                  0.016500   1.000  0.010

15001211 15   Corn, field, meal-babyfood         0.016500   1.000  0.010

15001220 15   Corn, field, bran                  0.016500   1.000  0.010

15001230 15   Corn, field, starch                0.016500   1.000  0.010

15001231 15   Corn, field, starch-babyfood       0.016500   1.000  0.010

15001240 15   Corn, field, syrup                 0.004950   1.000  0.010

15001241 15   Corn, field, syrup-babyfood        0.004950   1.000  0.010

15001250 15   Corn, field, oil                   0.016500   1.000  0.010

15001251 15   Corn, field, oil-babyfood          0.016500   1.000  0.010

15001260 15   Corn, pop                          0.016500   1.000  0.010

15001270 15   Corn, sweet                        0.016500   1.000  0.010

15001271 15   Corn, sweet-babyfood               0.016500   1.000  0.010

09021350 9B   Cucumber                           0.009570   1.000  0.010

95001880 O    Hop                                0.066000   1.000  1.000

95002750 O    Peppermint                         0.066000   1.000  1.000

95002760 O    Peppermint, oil                    0.066000   1.000  1.000

95002790 O    Pineapple                          0.012500   1.000  1.000

95002791 O    Pineapple-babyfood                 0.012500   1.000  1.000

95002800 O    Pineapple, dried                   0.012500   5.000  1.000

95002810 O    Pineapple, juice                   0.012500   1.000  1.000

95002811 O    Pineapple, juice-babyfood          0.012500   1.000  1.000

95002830 O    Plantain                           0.015800   1.000  1.000

95002840 O    Plantain, dried                    0.015800   3.900  1.000

01032960 1C   Potato, chips                      0.022800   1.000  0.050

01032970 1C   Potato, dry (granules/ flakes)     0.022800   6.500  0.050

01032971 1C   Potato, dry (granules/ flakes)-b   0.022800   6.500  0.050

01032980 1C   Potato, flour                      0.022800   1.000  0.050

01032981 1C   Potato, flour-babyfood             0.022800   1.000  0.050

01032990 1C   Potato, tuber, w/peel              0.022800   1.000  0.050

01032991 1C   Potato, tuber, w/peel-babyfood     0.022800   1.000  0.050

01033000 1C   Potato, tuber, w/o peel            0.022800   1.000  0.050

01033001 1C   Potato, tuber, w/o peel-babyfood   0.022800   1.000  0.050

95003520 O    Spearmint                          0.066000   1.000  1.000

95003530 O    Spearmint, oil                     0.066000   1.000  1.000

95003620 O    Sugarcane, sugar                   0.016500   1.000  0.050

95003621 O    Sugarcane, sugar-babyfood          0.016500   1.000  0.050

95003630 O    Sugarcane, molasses                0.016500   1.000  0.050

95003631 O    Sugarcane, molasses-babyfood       0.016500   1.000  0.050

01033660 1CD  Sweet potato                       0.007600   1.000  0.150

01033661 1CD  Sweet potato-babyfood              0.007600   1.000  0.150

Attachment 7.  Acute Food plus Water Results file.  Water at 138 ppb.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHOPROP                            (1994-98 data)

Residue file: ethopropacuterefinedARShopsandmintfoodonlywaterat138.R98

Adjustment factor #2 NOT used.

Analysis Date: 06-10-2008/10:31:00    Residue file dated: 06-06-2008/13:28:13/8

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "Pup Brain 8 hour; water at 138"

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

                  ---------- --------  ---------- --------  ---------- --------

U.S. Population:

                    0.007243    95.30    0.013615   179.15    0.027150   357.23

All infants:

                    0.027228   358.26    0.038931   512.25    0.069737   917.60

Children 1-2 yrs:

                    0.011428   150.37    0.019071   250.94    0.027314   359.39

Children 3-5 yrs:

                    0.010401   136.85    0.016252   213.84    0.026841   353.18

Children 6-12 yrs:

                    0.007218    94.98    0.012019   158.14    0.016267   214.04

Youth 13-19 yrs:

                    0.005909    77.75    0.009794   128.87    0.017791   234.10

Adults 20-49 yrs:

                    0.006699    88.15    0.011180   147.11    0.020315   267.31

Adults 50+ yrs:

                    0.006060    79.74    0.008646   113.76    0.014073   185.17

Females 13-49 yrs:

                    0.006740    88.68    0.010826   142.44    0.019198   252.61

Attachment 8.  Acute Food plus Water Results file.  Water at 15 ppb.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHOPROP                            (1994-98 data)

Residue file: ethopropacuterefinedARShopsandmintfoodonlywaterat15.R98

Adjustment factor #2 NOT used.

Analysis Date: 06-10-2008/10:25:22    Residue file dated: 06-06-2008/13:30:00/8

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "Pup Brain 8 hour; water at 15 ppb"

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

                  ---------- --------  ---------- --------  ---------- --------

U.S. Population:

                    0.000836    11.01    0.001532    20.15    0.002997    39.43

All infants:

                    0.003003    39.51    0.004319    56.83    0.007529    99.07

Children 1-2 yrs:

                    0.001433    18.85    0.002265    29.81    0.003098    40.76

Children 3-5 yrs:

                    0.001218    16.03    0.001869    24.59    0.003044    40.05

Children 6-12 yrs:

                    0.000837    11.02    0.001377    18.12    0.001882    24.76

Youth 13-19 yrs:

                    0.000669     8.80    0.001089    14.33    0.001999    26.30

Adults 20-49 yrs:

                    0.000751     9.88    0.001233    16.22    0.002240    29.48

Adults 50+ yrs:

                    0.000690     9.09    0.000973    12.80    0.001552    20.41

Females 13-49 yrs:

                    0.000749     9.86    0.001228    16.16    0.002091    27.52

Attachment 9.  Acute Food plus Water Results file.  Water at 231 ppt.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHOPROP                            (1994-98 data)

Residue file: ethopropacuterefinedARShopsandmintfoodonlywaterat231ppt.R98

Adjustment factor #2 NOT used.

Analysis Date: 06-10-2008/13:35:50    Residue file dated: 06-10-2008/13:30:02/8

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "Pup Brain 8 hour; water at 231 ppt"

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

                  ---------- --------  ---------- --------  ---------- --------

U.S. Population:

                    0.000108     1.42    0.000307     4.03    0.000673     8.86

All infants:

                    0.000365     4.80    0.000678     8.92    0.001409    18.54

Children 1-2 yrs:

                    0.000452     5.95    0.000716     9.41    0.001268    16.68

Children 3-5 yrs:

                    0.000313     4.12    0.000507     6.67    0.001052    13.84

Children 6-12 yrs:

                    0.000163     2.14    0.000324     4.27    0.000608     8.01

Youth 13-19 yrs:

                    0.000078     1.02    0.000164     2.16    0.000348     4.57

Adults 20-49 yrs:

                    0.000090     1.18    0.000167     2.20    0.000436     5.74

Adults 50+ yrs:

                    0.000095     1.25    0.000176     2.32    0.000467     6.14

Females 13-49 yrs:

                    0.000094     1.24    0.000171     2.25    0.000434     5.70

Attachment 10.  Acute Food plus Water Results file.  Water at 520 ppt.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHOPROP                            (1994-98 data)

Residue file: ethopropacuterefinedARShopsandmintfoodonlywaterat520ppt.R98

Adjustment factor #2 NOT used.

Analysis Date: 06-10-2008/10:36:29    Residue file dated: 06-10-2008/09:47:48/8

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "Pup Brain 8 hour; water at 520 ppt"

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

                  ---------- --------  ---------- --------  ---------- --------

U.S. Population:

                    0.000116     1.53    0.000315     4.14    0.000684     9.00

All infants:

                    0.000383     5.04    0.000702     9.23    0.001419    18.67

Children 1-2 yrs:

                    0.000463     6.09    0.000728     9.59    0.001271    16.72

Children 3-5 yrs:

                    0.000322     4.24    0.000515     6.77    0.001066    14.02

Children 6-12 yrs:

                    0.000171     2.25    0.000332     4.37    0.000627     8.25

Youth 13-19 yrs:

                    0.000083     1.09    0.000171     2.25    0.000353     4.65

Adults 20-49 yrs:

                    0.000097     1.27    0.000175     2.30    0.000441     5.80

Adults 50+ yrs:

                    0.000101     1.33    0.000183     2.41    0.000472     6.21

Females 13-49 yrs:

                    0.000101     1.32    0.000175     2.31    0.000439     5.78

Attachment 11.  Acute Food only Results file.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHOPROP                            (1994-98 data)

Residue file: ethopropacuterefinedARShopsandmintfoodonly.R98

Adjustment factor #2 NOT used.

Analysis Date: 06-10-2008/10:11:12    Residue file dated: 06-03-2008/09:45:57/8

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "Pup Brain 8 hour; food only"

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

                  ---------- --------  ---------- --------  ---------- --------

U.S. Population:

                    0.000102     1.34    0.000301     3.96    0.000668     8.79

All infants:

                    0.000349     4.59    0.000661     8.70    0.001398    18.40

Children 1-2 yrs:

                    0.000445     5.85    0.000720     9.48    0.001268    16.69

Children 3-5 yrs:

                    0.000304     4.00    0.000502     6.61    0.001026    13.50

Children 6-12 yrs:

                    0.000158     2.08    0.000320     4.22    0.000632     8.32

Youth 13-19 yrs:

                    0.000075     0.99    0.000158     2.08    0.000339     4.46

Adults 20-49 yrs:

                    0.000085     1.11    0.000162     2.14    0.000435     5.72

Adults 50+ yrs:

                    0.000089     1.17    0.000170     2.24    0.000464     6.10

Females 13-49 yrs:

                    0.000089     1.17    0.000164     2.16    0.000426     5.61Attachment 12.  Chronic Food plus Water Results file.  Water at 18 ppb.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprchronicefinedARShopsandmintwaterat18ppb .R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/15:18:15     Residue file dated: 06-10-2008/15:17:34/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

COMMENT 1: Chronic BMD10 = 0.0014;  water at 18 ppb

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ---------------

U.S. Population (total)                     0.000387                27.6%

U.S. Population (spring season)             0.000383                27.4%

U.S. Population (summer season)             0.000414                29.6%

U.S. Population (autumn season)             0.000374                26.7%

U.S. Population (winter season)             0.000374                26.7%

Northeast region                            0.000354                25.3%

Midwest region                              0.000391                27.9%

Southern region                             0.000367                26.2%

Western region                              0.000443                31.6%

Hispanics                                   0.000440                31.5%

Non-hispanic whites                         0.000377                26.9%

Non-hispanic blacks                         0.000367                26.2%

Non-hisp/non-white/non-black                0.000474                33.8%

All infants (< 1 year)                      0.001266                90.4%

Nursing infants                             0.000476                34.0%

Non-nursing infants                         0.001566               111.8%

Children 1-6  yrs                           0.000551                39.4%

Children 7-12 yrs                           0.000352                25.2%

Females 13-19 (not preg or nursing)         0.000270                19.3%

Females 20+ (not preg or nursing)           0.000384                27.4%

Females 13-50 yrs                           0.000372                26.6%

Females 13+ (preg/not nursing)              0.000376                26.9%

Females 13+ (nursing)                       0.000533                38.1%

Males 13-19 yrs                             0.000283                20.2%

Males 20+ yrs                               0.000345                24.7%

Seniors 55+                                 0.000379                27.0%

Children 1-2 yrs                            0.000595                42.5%

Children 3-5 yrs                            0.000545                38.9%

Children 6-12 yrs                           0.000372                26.6%

Youth 13-19 yrs                             0.000278                19.8%

Adults 20-49 yrs                            0.000359                25.7%

Adults 50+ yrs                              0.000379                27.1%

Females 13-49 yrs                           0.000357                25.5%

------------------------------------------------------------------------ -------

Attachment 13.  Chronic Food plus Water Results file.  Water at 231 ppt.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprchronicefinedARShopsandmintwaterat231pp t.R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/14:32:52     Residue file dated: 06-10-2008/14:32:17/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

COMMENT 1: Chronic BMD10 = 0.0014;  water at 231 ppt

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ---------------

U.S. Population (total)                     0.000012                 0.9%

U.S. Population (spring season)             0.000012                 0.9%

U.S. Population (summer season)             0.000012                 0.9%

U.S. Population (autumn season)             0.000012                 0.8%

U.S. Population (winter season)             0.000012                 0.9%

Northeast region                            0.000012                 0.9%

Midwest region                              0.000012                 0.9%

Southern region                             0.000011                 0.8%

Western region                              0.000014                 1.0%

Hispanics                                   0.000015                 1.1%

Non-hispanic whites                         0.000011                 0.8%

Non-hispanic blacks                         0.000011                 0.8%

Non-hisp/non-white/non-black                0.000014                 1.0%

All infants (< 1 year)                      0.000038                 2.7%

Nursing infants                             0.000021                 1.5%

Non-nursing infants                         0.000045                 3.2%

Children 1-6  yrs                           0.000028                 2.0%

Children 7-12 yrs                           0.000012                 0.9%

Females 13-19 (not preg or nursing)         0.000006                 0.5%

Females 20+ (not preg or nursing)           0.000010                 0.7%

Females 13-50 yrs                           0.000010                 0.7%

Females 13+ (preg/not nursing)              0.000012                 0.8%

Females 13+ (nursing)                       0.000015                 1.0%

Males 13-19 yrs                             0.000008                 0.5%

Males 20+ yrs                               0.000010                 0.7%

Seniors 55+                                 0.000011                 0.8%

Children 1-2 yrs                            0.000038                 2.7%

Children 3-5 yrs                            0.000024                 1.7%

Children 6-12 yrs                           0.000013                 0.9%

Youth 13-19 yrs                             0.000007                 0.5%

Adults 20-49 yrs                            0.000009                 0.7%

Adults 50+ yrs                              0.000011                 0.8%

Females 13-49 yrs                           0.000009                 0.7%

------------------------------------------------------------------------ -------

Attachment 14.  Chronic Food plus Water Results file.  Water at 520 ppt.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprchronicefinedARShopsandmintwaterat520pp t.R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/09:59:15     Residue file dated: 06-10-2008/09:54:35/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

COMMENT 1: Chronic BMD10 = 0.0014;  water at 520 ppt

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ---------------

U.S. Population (total)                     0.000018                 1.3%

U.S. Population (spring season)             0.000018                 1.3%

U.S. Population (summer season)             0.000019                 1.3%

U.S. Population (autumn season)             0.000018                 1.3%

U.S. Population (winter season)             0.000018                 1.3%

Northeast region                            0.000018                 1.3%

Midwest region                              0.000018                 1.3%

Southern region                             0.000017                 1.2%

Western region                              0.000021                 1.5%

Hispanics                                   0.000022                 1.6%

Non-hispanic whites                         0.000017                 1.2%

Non-hispanic blacks                         0.000017                 1.2%

Non-hisp/non-white/non-black                0.000022                 1.6%

All infants (< 1 year)                      0.000058                 4.2%

Nursing infants                             0.000028                 2.0%

Non-nursing infants                         0.000070                 5.0%

Children 1-6  yrs                           0.000036                 2.6%

Children 7-12 yrs                           0.000018                 1.3%

Females 13-19 (not preg or nursing)         0.000011                 0.8%

Females 20+ (not preg or nursing)           0.000016                 1.2%

Females 13-50 yrs                           0.000016                 1.1%

Females 13+ (preg/not nursing)              0.000018                 1.3%

Females 13+ (nursing)                       0.000023                 1.6%

Males 13-19 yrs                             0.000012                 0.9%

Males 20+ yrs                               0.000015                 1.1%

Seniors 55+                                 0.000017                 1.2%

Children 1-2 yrs                            0.000047                 3.4%

Children 3-5 yrs                            0.000033                 2.3%

Children 6-12 yrs                           0.000019                 1.3%

Youth 13-19 yrs                             0.000011                 0.8%

Adults 20-49 yrs                            0.000015                 1.1%

Adults 50+ yrs                              0.000017                 1.2%

Females 13-49 yrs                           0.000015                 1.1%

------------------------------------------------------------------------ -------

Attachment 15.  Chronic Food only Results file.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprchronicefinedARShopsandmintfoodonly.R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/09:57:48     Residue file dated: 06-10-2008/09:51:45/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

COMMENT 1: Chronic BMD10 = 0.0014;  food only

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ---------------

U.S. Population (total)                     0.000007                 0.5%

U.S. Population (spring season)             0.000007                 0.5%

U.S. Population (summer season)             0.000007                 0.5%

U.S. Population (autumn season)             0.000007                 0.5%

U.S. Population (winter season)             0.000008                 0.5%

Northeast region                            0.000008                 0.5%

Midwest region                              0.000007                 0.5%

Southern region                             0.000006                 0.4%

Western region                              0.000008                 0.6%

Hispanics                                   0.000010                 0.7%

Non-hispanic whites                         0.000007                 0.5%

Non-hispanic blacks                         0.000007                 0.5%

Non-hisp/non-white/non-black                0.000008                 0.6%

All infants (< 1 year)                      0.000022                 1.6%

Nursing infants                             0.000015                 1.1%

Non-nursing infants                         0.000025                 1.8%

Children 1-6  yrs                           0.000021                 1.5%

Children 7-12 yrs                           0.000008                 0.6%

Females 13-19 (not preg or nursing)         0.000003                 0.2%

Females 20+ (not preg or nursing)           0.000005                 0.4%

Females 13-50 yrs                           0.000005                 0.4%

Females 13+ (preg/not nursing)              0.000007                 0.5%

Females 13+ (nursing)                       0.000008                 0.6%

Males 13-19 yrs                             0.000004                 0.3%

Males 20+ yrs                               0.000005                 0.4%

Seniors 55+                                 0.000006                 0.4%

Children 1-2 yrs                            0.000031                 2.2%

Children 3-5 yrs                            0.000018                 1.3%

Children 6-12 yrs                           0.000008                 0.6%

Youth 13-19 yrs                             0.000003                 0.2%

Adults 20-49 yrs                            0.000005                 0.3%

Adults 50+ yrs                              0.000006                 0.4%

Females 13-49 yrs                           0.000005                 0.3%

------------------------------------------------------------------------ -------

Attachment 16.  Cancer Food plus Water Results file.  Water at 10.1 ppb.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintwaterat10ppb. R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/10:40:56     Residue file dated: 06-10-2008/09:55:40/8

Q* = 0.0281

COMMENT 1: Water at 10.1 ppb

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0281)

--------------------------------------   -------------     -------------

U.S. Population (total)                     0.000222         6.25E-06

U.S. Population (spring season)             0.000220         6.19E-06

U.S. Population (summer season)             0.000238         6.68E-06

U.S. Population (autumn season)             0.000215         6.04E-06

U.S. Population (winter season)             0.000216         6.06E-06

Northeast region                            0.000204         5.74E-06

Midwest region                              0.000225         6.31E-06

Southern region                             0.000211         5.92E-06

Western region                              0.000255         7.15E-06

Hispanics                                   0.000254         7.14E-06

Non-hispanic whites                         0.000217         6.09E-06

Non-hispanic blacks                         0.000211         5.92E-06

Non-hisp/non-white/non-black                0.000272         7.64E-06

All infants (< 1 year)                      0.000726         2.04E-05

Nursing infants                             0.000278         7.80E-06

Non-nursing infants                         0.000896         2.52E-05

Children 1-6  yrs                           0.000325         9.12E-06

Children 7-12 yrs                           0.000204         5.73E-06

Females 13-19 (not preg or nursing)         0.000154         4.33E-06

Females 20+ (not preg or nursing)           0.000220         6.17E-06

Females 13-50 yrs                           0.000213         5.99E-06

Females 13+ (preg/not nursing)              0.000216         6.07E-06

Females 13+ (nursing)                       0.000305         8.57E-06

Males 13-19 yrs                             0.000162         4.56E-06

Males 20+ yrs                               0.000198         5.56E-06

Seniors 55+                                 0.000217         6.10E-06

Children 1-2 yrs                            0.000356         9.99E-06

Children 3-5 yrs                            0.000319         8.96E-06

Children 6-12 yrs                           0.000215         6.05E-06

Youth 13-19 yrs                             0.000159         4.46E-06

Adults 20-49 yrs                            0.000205         5.77E-06

Adults 50+ yrs                              0.000217         6.10E-06

Females 13-49 yrs                           0.000204         5.74E-06

------------------------------------------------------------------------ -------

Attachment 17.  Cancer Food plus Water Results file.  Water at 5 ppb.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintwaterat5ppb.R 98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/10:04:46     Residue file dated: 06-10-2008/10:02:26/8

Q* = 0.0281

COMMENT 1: Water at 5 ppb

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0281)

--------------------------------------   -------------     -------------

U.S. Population (total)                     0.000115         3.22E-06

U.S. Population (spring season)             0.000114         3.20E-06

U.S. Population (summer season)             0.000122         3.43E-06

U.S. Population (autumn season)             0.000111         3.12E-06

U.S. Population (winter season)             0.000112         3.14E-06

Northeast region                            0.000106         2.98E-06

Midwest region                              0.000116         3.26E-06

Southern region                             0.000108         3.05E-06

Western region                              0.000131         3.69E-06

Hispanics                                   0.000132         3.71E-06

Non-hispanic whites                         0.000112         3.14E-06

Non-hispanic blacks                         0.000109         3.06E-06

Non-hisp/non-white/non-black                0.000140         3.94E-06

All infants (< 1 year)                      0.000374         1.05E-05

Nursing infants                             0.000147         4.13E-06

Non-nursing infants                         0.000460         1.29E-05

Children 1-6  yrs                           0.000174         4.90E-06

Children 7-12 yrs                           0.000106         2.98E-06

Females 13-19 (not preg or nursing)         0.000078         2.20E-06

Females 20+ (not preg or nursing)           0.000112         3.15E-06

Females 13-50 yrs                           0.000109         3.07E-06

Females 13+ (preg/not nursing)              0.000112         3.14E-06

Females 13+ (nursing)                       0.000156         4.39E-06

Males 13-19 yrs                             0.000083         2.34E-06

Males 20+ yrs                               0.000102         2.85E-06

Seniors 55+                                 0.000112         3.14E-06

Children 1-2 yrs                            0.000196         5.51E-06

Children 3-5 yrs                            0.000169         4.76E-06

Children 6-12 yrs                           0.000112         3.15E-06

Youth 13-19 yrs                             0.000081         2.28E-06

Adults 20-49 yrs                            0.000105         2.95E-06

Adults 50+ yrs                              0.000112         3.14E-06

Females 13-49 yrs                           0.000104         2.93E-06

------------------------------------------------------------------------ -------

Attachment 18.  Cancer Food plus Water Results file.  Water at 231 ppt.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintwaterat231ppt .R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/14:49:43     Residue file dated: 06-10-2008/14:40:20/8

Q* = 0.0281

COMMENT 1: Water at 231 ppt

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0281)

--------------------------------------   -------------     -------------

U.S. Population (total)                     0.000014         4.00E-07

U.S. Population (spring season)             0.000014         3.98E-07

U.S. Population (summer season)             0.000014         3.99E-07

U.S. Population (autumn season)             0.000014         3.91E-07

U.S. Population (winter season)             0.000015         4.13E-07

Northeast region                            0.000014         4.03E-07

Midwest region                              0.000014         4.01E-07

Southern region                             0.000013         3.64E-07

Western region                              0.000016         4.55E-07

Hispanics                                   0.000018         5.06E-07

Non-hispanic whites                         0.000014         3.85E-07

Non-hispanic blacks                         0.000013         3.75E-07

Non-hisp/non-white/non-black                0.000017         4.74E-07

All infants (< 1 year)                      0.000044         1.24E-06

Nursing infants                             0.000025         6.91E-07

Non-nursing infants                         0.000051         1.44E-06

Children 1-6  yrs                           0.000034         9.53E-07

Children 7-12 yrs                           0.000015         4.19E-07

Females 13-19 (not preg or nursing)         0.000008         2.14E-07

Females 20+ (not preg or nursing)           0.000012         3.35E-07

Females 13-50 yrs                           0.000012         3.35E-07

Females 13+ (preg/not nursing)              0.000014         3.91E-07

Females 13+ (nursing)                       0.000017         4.72E-07

Males 13-19 yrs                             0.000009         2.59E-07

Males 20+ yrs                               0.000011         3.21E-07

Seniors 55+                                 0.000013         3.63E-07

Children 1-2 yrs                            0.000047         1.31E-06

Children 3-5 yrs                            0.000030         8.34E-07

Children 6-12 yrs                           0.000016         4.45E-07

Youth 13-19 yrs                             0.000008         2.37E-07

Adults 20-49 yrs                            0.000011         3.12E-07

Adults 50+ yrs                              0.000013         3.61E-07

Females 13-49 yrs                           0.000011         3.01E-07

------------------------------------------------------------------------ -------

Attachment 19.  Cancer Food plus Water Results file.  Water at 520 ppt.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintwaterat520ppt .R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/14:50:17     Residue file dated: 06-10-2008/09:57:10/8

Q* = 0.0281

COMMENT 1: Water at 520 ppt

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0281)

--------------------------------------   -------------     -------------

U.S. Population (total)                     0.000020         5.71E-07

U.S. Population (spring season)             0.000020         5.68E-07

U.S. Population (summer season)             0.000021         5.83E-07

U.S. Population (autumn season)             0.000020         5.57E-07

U.S. Population (winter season)             0.000021         5.79E-07

Northeast region                            0.000020         5.59E-07

Midwest region                              0.000020         5.74E-07

Southern region                             0.000019         5.26E-07

Western region                              0.000023         6.51E-07

Hispanics                                   0.000025         7.00E-07

Non-hispanic whites                         0.000020         5.52E-07

Non-hispanic blacks                         0.000019         5.38E-07

Non-hisp/non-white/non-black                0.000024         6.84E-07

All infants (< 1 year)                      0.000064         1.80E-06

Nursing infants                             0.000032         8.99E-07

Non-nursing infants                         0.000076         2.14E-06

Children 1-6  yrs                           0.000042         1.19E-06

Children 7-12 yrs                           0.000020         5.74E-07

Females 13-19 (not preg or nursing)         0.000012         3.34E-07

Females 20+ (not preg or nursing)           0.000018         5.06E-07

Females 13-50 yrs                           0.000018         5.01E-07

Females 13+ (preg/not nursing)              0.000020         5.57E-07

Females 13+ (nursing)                       0.000025         7.10E-07

Males 13-19 yrs                             0.000014         3.85E-07

Males 20+ yrs                               0.000017         4.75E-07

Seniors 55+                                 0.000019         5.31E-07

Children 1-2 yrs                            0.000056         1.57E-06

Children 3-5 yrs                            0.000038         1.07E-06

Children 6-12 yrs                           0.000022         6.09E-07

Youth 13-19 yrs                             0.000013         3.61E-07

Adults 20-49 yrs                            0.000017         4.72E-07

Adults 50+ yrs                              0.000019         5.29E-07

Females 13-49 yrs                           0.000016         4.60E-07

------------------------------------------------------------------------ -------

Attachment 20.  Cancer Food only Results file.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintfoodonly.R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/09:59:54     Residue file dated: 06-10-2008/09:41:18/8

Q* = 0.0281

COMMENT 1: Food only

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0281)

--------------------------------------   -------------     -------------

U.S. Population (total)                     0.000009         2.63E-07

U.S. Population (spring season)             0.000009         2.63E-07

U.S. Population (summer season)             0.000009         2.52E-07

U.S. Population (autumn season)             0.000009         2.59E-07

U.S. Population (winter season)             0.000010         2.81E-07

Northeast region                            0.000010         2.78E-07

Midwest region                              0.000009         2.62E-07

Southern region                             0.000008         2.34E-07

Western region                              0.000011         2.99E-07

Hispanics                                   0.000012         3.51E-07

Non-hispanic whites                         0.000009         2.51E-07

Non-hispanic blacks                         0.000009         2.45E-07

Non-hisp/non-white/non-black                0.000011         3.07E-07

All infants (< 1 year)                      0.000028         7.87E-07

Nursing infants                             0.000019         5.25E-07

Non-nursing infants                         0.000032         8.86E-07

Children 1-6  yrs                           0.000027         7.62E-07

Children 7-12 yrs                           0.000010         2.94E-07

Females 13-19 (not preg or nursing)         0.000004         1.17E-07

Females 20+ (not preg or nursing)           0.000007         1.98E-07

Females 13-50 yrs                           0.000007         2.03E-07

Females 13+ (preg/not nursing)              0.000009         2.58E-07

Females 13+ (nursing)                       0.000010         2.83E-07

Males 13-19 yrs                             0.000006         1.58E-07

Males 20+ yrs                               0.000007         1.99E-07

Seniors 55+                                 0.000008         2.29E-07

Children 1-2 yrs                            0.000039         1.11E-06

Children 3-5 yrs                            0.000023         6.44E-07

Children 6-12 yrs                           0.000011         3.13E-07

Youth 13-19 yrs                             0.000005         1.38E-07

Adults 20-49 yrs                            0.000007         1.84E-07

Adults 50+ yrs                              0.000008         2.27E-07

Females 13-49 yrs                           0.000006         1.74E-07

------------------------------------------------------------------------ -------

Attachment 21.  Chronic Critical Commodity Contribution Analyses.  Water at 18 ppb.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprchronicefinedARShopsandmintwaterat18ppb .R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/10:42:55     Residue file dated: 06-10-2008/10:03:10/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

COMMENT 1: Chronic BMD10 = 0.0014;  water at 18 ppb

======================================================================== =======

                 Critical Commodity Contribution Analysis for

                            U.S. Population (total)

                 Total Exposure =.0002257 mg/kg bw/day

            Crop groups with total exposure contribution > 1%

              Foods/Foodforms with exposure contribution > .5%

------------------------------------------------------------------------ -------

Crop group                               ----------Exposure Analysis-------

   Food                                     mg/kg     % of Total   Percent

      Foodform                           body wt/day   Exposure    of RfD

--------------------------------------   -----------  ----------  ---------

Crop Group = (O)  Other

   Banana (95000230):

        FoodForm N/S                       0.0000044      1.95%       0.32%

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0002184     96.78%      15.60%

--------------------------------------   -----------  ----------  ---------

  Total for crop group                     0.0002251     99.72%      16.08%

Total for crop groups listed above:        0.0002251     99.72%      16.1%

------------------------------------------------------------------------ -------

                 Critical Commodity Contribution Analysis for

                            All infants (< 1 year)

                 Total Exposure =.0001891 mg/kg bw/day

            Crop groups with total exposure contribution > 1%

              Foods/Foodforms with exposure contribution > .5%

------------------------------------------------------------------------ -------

Crop group                               ----------Exposure Analysis-------

   Food                                     mg/kg     % of Total   Percent

      Foodform                           body wt/day   Exposure    of RfD

--------------------------------------   -----------  ----------  ---------

Crop Group = (O)  Other

   Banana (95000230):

        FoodForm N/S                       0.0000063      3.35%       0.45%

   Banana-babyfood (95000231):

        FoodForm N/S                       0.0000088      4.63%       0.63%

   Banana, dried-babyfood (95000241):

        FoodForm N/S                       0.0000038      2.03%       0.27%

   Pineapple, juice-babyfood (95002811):

        FoodForm N/S                       0.0000012      0.62%       0.08%

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0001657     87.64%      11.84%

   Water, indirect, all sources (86020000):

        FoodForm N/S                       0.0000011      0.57%       0.08%

--------------------------------------   -----------  ----------  ---------

  Total for crop group                     0.0001885     99.68%      13.47%

Total for crop groups listed above:        0.0001885     99.68%      13.5%

------------------------------------------------------------------------ -------

                 Critical Commodity Contribution Analysis for

                               Children 1-2 yrs

                 Total Exposure =.0003668 mg/kg bw/day

            Crop groups with total exposure contribution > 1%

              Foods/Foodforms with exposure contribution > .5%

------------------------------------------------------------------------ -------

Crop group                               ----------Exposure Analysis-------

   Food                                     mg/kg     % of Total   Percent

      Foodform                           body wt/day   Exposure    of RfD

--------------------------------------   -----------  ----------  ---------

Crop Group = (O)  Other

   Banana (95000230):

        FoodForm N/S                       0.0000220      6.00%       1.57%

   Pineapple, juice (95002810):

        FoodForm N/S                       0.0000041      1.12%       0.29%

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0003354     91.45%      23.96%

--------------------------------------   -----------  ----------  ---------

  Total for crop group                     0.0003655     99.66%      26.11%

Total for crop groups listed above:        0.0003655     99.66%      26.1%

------------------------------------------------------------------------ -------

                 Critical Commodity Contribution Analysis for

                               Children 3-5 yrs

                 Total Exposure =.0003805 mg/kg bw/day

            Crop groups with total exposure contribution > 1%

              Foods/Foodforms with exposure contribution > .5%

------------------------------------------------------------------------ -------

Crop group                               ----------Exposure Analysis-------

   Food                                     mg/kg     % of Total   Percent

      Foodform                           body wt/day   Exposure    of RfD

--------------------------------------   -----------  ----------  ---------

Crop Group = (O)  Other

   Banana (95000230):

        FoodForm N/S                       0.0000121      3.18%       0.86%

   Pineapple, juice (95002810):

        FoodForm N/S                       0.0000024      0.63%       0.17%

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0003627     95.32%      25.91%

--------------------------------------   -----------  ----------  ---------

  Total for crop group                     0.0003794     99.70%      27.10%

Total for crop groups listed above:        0.0003794     99.70%      27.1%

------------------------------------------------------------------------ -------

Attachment 22.  Cancer Critical Commodity Contribution Analyses.  Water at 10.1 ppb.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHOPROP                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\Ethoprop\DEEM\ethoproprcancerefinedARShopsandmintwaterat10ppb. R98

                                                     Adjustment factor #2 used.

Analysis Date 06-10-2008/10:41:46     Residue file dated: 06-10-2008/09:55:40/8

Q* = 0.0281

COMMENT 1: Water at 10.1 ppb

======================================================================== =======

                 Critical Commodity Contribution Analysis for

                            U.S. Population (total)

                 Total Exposure =.0002223 mg/kg bw/day

            Crop groups with total exposure contribution > 1%

              Foods/Foodforms with exposure contribution > .5%

------------------------------------------------------------------------ -------

Crop group                               -----------Exposure analysis----------

   Food                                     mg/kg   | % of Total| Lifetime Risk

      Foodform                           body wt/day|  Exposure |(Q*= .0281)

--------------------------------------   -----------|-----------|--------------

Crop Group = (O)  Other

   Banana (95000230):

        FoodForm N/S                       0.0000054     2.41%        1.51E-07

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0001226    55.14%        3.44E-06

   Water, indirect, all sources (86020000):

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        FoodForm N/S                       0.0000903    40.64%        2.54E-06

--------------------------------------   -----------|-----------|--------------

  Total for crop group                     0.0002208    99.33%        6.20E-06

Total for crop groups listed above:        0.0002208    99.33%        6.20E-06

------------------------------------------------------------------------ -------

Ethoprop	                                          Dietary Exposure and Risk Assessment             DP Number:  352232 and 352234

PC Code:  041101

 PAGE

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