Mefenp yr - dieth yl Dietary Exposure and Risk Assessment PC Code: 811800 UNITED STA

TES ENVIRONMENTA L PROTECTION AGENCY

MEMORANDUM Date: February 22 , 2011 SUBJECT: Mefenpyr - diethyl (HOE 107892) Safener

Dietary ( F ood and Drinking Water) Section 3 Registration Action on Sorghum and Grasses Grown for Seed PC Code: 811800 Decision No.: 425581 Petition No.: PP# 9F7679 Risk Assessment Type: Dietary T XR No.: NA MRID No.: NA FROM: Alexandra LaMay , Biologist

Risk Assessment Branch VII Health Effects Division (7509P) THROUGH: Meheret Negussie

Sheila Piper , Chemist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division (7509P) and Michael S. Metzger, Chief Risk Assessment Branch VII Health Effects Division (7509P) TO: Bethan y Benbow

Herbicide Branch Registration D Dietary Exposure and Risk Assessment D

Page 1 of 12 UNITED STA

TES ENVIRONMENTA L PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

, 2011 diethyl (HOE 107892) Safener Revised Chronic Aggregate ood and Drinking Water) Exposure and Risk Assessment for the Registration Action to Add New Use s and Establish Tolerances on Sorghum and Grasses Grown for Seed . DP Barcode: 380767 Registration No. : NA Regulatory Action: Section 3 Dietary Case No.: NA

CAS No.: 135590 - 91 - 9 40 CFR: 180.509 Alexandra LaMay , Biologist Risk Assessment Branch VII Health Effects Division (7509P) Meheret Negussie , Chemist

, Chemist Dietary Exposure Science Advisory Council (DESAC) Effects Division (7509P) Michael S. Metzger, Chief Risk Assessment Branch VII Health Effects Division (7509P) Bethan y Benbow Herbicide Branch Registration D ivision (7 505 P) D 380767 UNITED STA

TES ENVIRONMENTA L PROTECTION AGENCY CHEMICAL SAFETY AND POLLUTION PREVENTION

Chronic Aggregate Exposure and Risk Assessment for the

s and Establish Tolerances

Section 3Mefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 2 of 12 Executive Summary A c hronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary E xposure Evaluation Model software with the Food Commodity

I ntake Database DEEM - FCIDTM, Version 2.03 which use s food consumption data from the U.S. Department of Agriculture’s Continuing S urvey s of Food Intakes by Individuals (CSFII) from 1994 - 1996 and 1998. The anal ys is was performed to support a Section 3 request to add new uses of the safener mefenp yr - diethyl , also known as HOE 107892, and to establish tolerances for sorghum and grasses grown for seed . Acute Dietary

Exposure Results and Characterization No toxic effects attributable to a single exposure of mefenp yr - diethyl were seen in the database; therefore , an acute dietary endpoint was not selected and an acute dietary risk assessme nt was not conducted. Chronic Dietary ( Food and Drinking Water) Exposure Results and Characterization A highl y conservative chronic dietary risk assessment was conducted for food only and for food and drinking water for mefenp yr - diethyl using tolerance level residues and assuming 100% crop treated. Mefenp yr - diethyl dietary exposure from food alone based on the newl y proposed use pattern results in an estimated risk equivalent to <1% of the chronic population adjusted dose ( cPAD ) for the general U.S. p opulation and all regulated subpopulations . The highest estimated drinking water concentration (EDWC), the chronic groundwater EDWC of 4 μg/L (ppb), was used for this dietary assessment. Additionally , exposure from food and drinking water based on the ne wl y proposed use pattern results in an estimated risk equivalent to <1% of the cPAD for the general population and all regulated subpopulations. Cancer Dietary

Exposure Results and Characterization Mefenp yr - diethyl is classified as a “not likel y” human c arcinogen; thus, a cancer dietary risk assessment is not required . 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 unreasona ble adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty

or safet y factors. For acute and non - cancer chroni c 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 m illion . References which discuss the acute and chronic risk assessments in more detail are availa ble on the EPA/pesticides web site: “Available In formation on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000,Mefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 3 of 12 web link: http://www.epa.gov/fedrgstr/EPA - PEST/20 00/July /Day - 12/6061.pdf ; or see SOP 99.6 ( 20 - AUG - 1999 ). The most recent dietary

risk assessment for mefenpy r - diethyl was conducted by Donna Davis ( 6/3/2008, D353114 ). II. Residue Information The residue of concern for both risk assessment and tolerance setting purposes in plants and animals is the parent compound, mefenp yr - diethyl, and its 2,4 - dichlor o pheny l py razoline metabolites. Tolerances for residues of the herbicide safener mefenpy r - dieth yl are established under 40 CFR §180.509. Toleranc es in plant commodities range from 0.05 ppm in wheat and barley grain to 0.5 ppm in wheat and barley straw. The rotational crop tolerance for soy bean and canola seed is 0.02 ppm . Animal commodity tolerances are established for cattle, goat, hog, horse, and sheep meat b yproducts at 0.1 ppm. Residue Data used for Acute, Chronic, and/or Cancer Assessments: Tolerance level residues and the assumption that 100% of the crop is treated were incorporated into the chronic dietary risk assessment for all existing and proposed uses. The proposed tolerance for sorghum was also incorporated into the assessment at the tolerance level assuming 100% crop treated. The recommended tolerance level for sorghum grain is 0.0 4 ppm ( A. LaMay , 2/22/11 , D380768 ). HED notes that in a previous dietary exposure assessment ( Y. Donovan, 11/22/2002, D286489) the following animal commodities were included: meat at 0.002 ppm, fat at 0.01 ppm, and milk at 0.002 ppm. The tissue residues were applied to cattle, goats, hogs, horses and sheep. These residues were selected from an exaggerated rate goat metabolism study , and were recommended for use in risk assessment even though tolerances were not required. HED has reconsidered the metabolism data and concludes that given the exaggeration rate of the metabolism study , detectable residues of mefenp yr - diethy l and its regulated metabolites are unlikely to result in meat, fat, and milk; therefore, these residue values have been excluded in subsequent dietary exposure assessment . Since barley

and wheat field trials conducted at exaggerated rate s (>5X) showed no detectable residues in wheat and barley grains, no tolerance is needed for processed commodities and concentration/reduction factors were not applied to wheat and barley commodities in this assessment. No processing data were submitted depicting the fate of mefenp yr - diethy l residues of concern in processed soy bean and canola commodities. However, given that residues above the limit of quantitation ( L OQ ) were found in only one sample from the rotational crop field trials run at an exaggerate rate and the fact that the tolerance is set at the sum of the respective individual L OQs, HED waived the requirement for a processing stud y and concluded that it i s unlikely that residues inMefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 4 of 12 processed commodities will exceed the established tolerances for so yb ean seed and canola seed. Therefore, concentration/reduction factors were not applied to canola and soy bean processed commodities in this assessment. No pr ocessing data have been submitted depicting fate of mefenp yr - diethyl residues of concern in processed sorghum commodities. Given that there were no residues above the LOQ in all grain samples from the sorghum crop field trials and the fact that the tolerances is set at the sum of respective individual L OQs, HED waives the requirement for a processing study

and concludes that it’s unlikely that residues in processed commodities will exce ed the established tolerances for sorghum. Therefore, concentration/reduction factors were not applied to sorghum processed commodities in this assessment. III. Drinking Water Data The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in response to tolerance petitions for uses on wheat and barley (A. Clem, 3/18/97, D226076; A. Clem, 11/26/01, D262735). The assessment was based on use of the safener at an exaggerate d rate o f 0.08 lb ai/A, which is higher than the currentl y requested use pattern; therefore, those estimated drinking water values remain valid and were incorporated directl y 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.” Monitoring data for mefenpy r - diethyl and its metabolites are not available; therefore , surface and ground water estimated drinking water concentrations (EDWCs) were deriv ed from models. The chronic surface water EDWC was calculated from the EFED FIRST (Tier 1) index reservoir simulation model for a single application of HOE - 107892 at an exaggerated rate of 0.090 kg/ha (0.080 lb/acre). The tabulated concentrations are the summations (in parent equivalent concentrations) of relativel y short - lived parent and several longer - lived transformation products that are structurall y similar to the parent compound. The chronic concentration of combined parent and metabolites comput ed from FI RST in parent equivalents is 3 ppb. The chronic groundwater EDWC was calculated using the SCI - GROW2 model. The database of pesticide chemicals used to develop and update the SCI - GROW2 regression model shows that the highest pesticide concentr ation measured on a one pound per acre application basis for a certain mobile and persistent pesticide of similar molecular weight is roughl y 55 μg/L (ppb). The current minimum value for K oc in the database used to develop SCI - GROW2 is 11 mL/g , while maxi mum values for aerobic soil metabolism half - life are roughl y 1000 day s. Since HOE - 107892 has K oc and aerobic soil metabolism half - lives well within the bounds covered b y the model, as do its structurally similar transformation products (from collateral la boratory evidence and reasonable inference),Mefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 5 of 12 groundwater concentrations of HOE - 107892 applied at exaggerated rate of 0.080 lb/acre/ ye ar and any associated transformation products (in equivalent molar concentrations) are not likely to exceed individually , o r in combination , a concentration of 4 μg/L (ppb). The models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . The higher value of the two, the chronic groundwater EDWC of 4 μg/L (ppb), was used for this dietary

assessment. IV. DEEM - FCIDTM Program and Consumption Information The mefenp yr - diethy l chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity I ntake Database DEEM - FCIDTM, Version 2.03 which incorporates consumption data from USDA’s Continuing Survey s of Food Intakes by I ndividuals (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 day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g. apples, peeled fruit - cooked; fresh o r N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y 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 p opulation subgroups. Based on analy sis 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 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ ye ars 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 dail y consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summe d 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 fo r each population subgroup. V. Toxicological Information HED reviewed the toxicological database for mefenpy r - diethyl in conjunction with the request to establish new rotational crop tolerances as a result of increasing the use rate for this safener. The following conclusions with respect to toxicological endpoints for dietary risk assessment were reached. No toxic effects attributable to a single exposureMefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 6 of 12 of mefenp yr - diethy l were seen in the database; therefore , an acute dietary endpoint was not selected . For dietary

anal ys is, onl y a chronic endpoint was selected (Table 1). Mefenp yr - diethyl is classified as a “not likel y” human carcinogen; thus, a cancer dietary risk assessment is not required. Based on a review of the toxicological database for mefenpy r - diethyl and the available exposure information, HED has determined that the FQPA Safet y Factor can be reduced to 1X. Table 1. Summary of Toxicological Doses and Endpoints for Mefenpyr - Diethyl for Use in Dietary Exp osure Risk Assessments Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD, Level

of Concern Study and Toxicological

Effects Ac ute Dietary No appropriate endpoint w as identified in oral toxicity studies including the developmental studies in rats and rabbits for risk assessment for any subpopulation . Chronic Dietary (All Populations) NOAEL =

51 mg/kg/day UF A= 10x

UF H = 10x FQPA SF= 1x Chronic RfD =

0.51 mg/kg/day cPAD = 0.51 mg/kg/day Chronic Toxicity Study in the

Beagle Dog. LOAEL = 260 mg/kg/day based on adverse findings in the liver (cholestasis, increased alkaline phosphatase, and increased liver weight in both sexes). Co - critical study: Chronic Toxicity Study in the Rat. LOAEL = 252 ♀/318♂ mg/kg/day based on significant increase in reticulocyte counts. (NOAEL = 60 mg/kg/day) Cancer (oral, dermal, inhalation) Mefenpyr - diethyl is classified as not likely to be a human carcinogen Point of Departure (POD) = A data point or an estimated point that is derived from observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity am ong members of the human population (in terspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose . VI. Results/Discussion As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCIDTM anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 2, below, are for the general U.S. Population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 1 2, y outh 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ y ears. Results of Chronic Dietary ( Food and Drinking Water) Exposure Analy s is Mefenp yr - diethyl chronic dietary exposure from food alone based on the newly proposed use pattern results in an estimated risk equivalent to <1% of the cPAD for the generalMefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 7 of 12 U.S. population and all regulated subpopulations. Additionally , exposure from food and drinking water based on the newl y proposed use pattern results in an estimated risk equivalent to <1% of the cPAD for the general populations and all regulated subpopulations. The results of the chronic dietary exposure anal ys is for all subpopulation s are reported in Table 2, below. Table 2. Summary of Dietary (Food Only and Food and Drinking Water) Exposure and Risk for Mefenpyr - diethyl Population Subgroup Chronic Dietary Food Only Chronic Dietary Food and Water Dietary Exposure (m g/kg/day) % cPAD* Dietary Exposure (m g/kg/day) % cPAD* General U.S. Population 0. 000 105 <1 0.000189 <1 All Infants (< 1 year old) 0.000 067 <1 0.000343 <1 Children 1 - 2 y ears old 0.000 235 <1 0.000360 <1 Children 3 - 5 y ears old 0.0002 39 <1 0.000356 <1 Children 6 - 12 years old 0.0001 67 <1 0.000248 <1 Youth 13 - 19 y ears old 0.0001 01 <1 0.000162 <1 Ad ults 20 - 49 y ears old 0.00 0 089 <1 0.000167 <1 Ad ults 50+ years old 0.000 070 <1 0.000153 <1 Fem ales 13 - 49 y ears old 0.000 080 <1 0.000158 <1 * The values for the highest exposed population for each type of risk assessment are bolded VII. Characterization of Inputs/Outputs HED has conducted a highly conservative, screening level chronic dietary exposure and risk assessment for mefenpy r - diethyl. The assessment assumes that all commodities for which there are tolerances contain residues of mefenpy r - diethyl at the tolerance le vel. Additionally , no reduction factors were used for processed commodities and modeled values were used for drinking water. Based on the conservative inputs into the anal ys is, it is unlikely

that the assessment will underestimate chronic dietary risks f rom the newly proposed use pattern for this safener. Additional refinements including the use of percent crop treated information and monitoring data could be incorporated into the assessment. However, since risk estimates are not of concern, a more h ighl y refined assessment is not needed at this time. VIII. ConclusionsMefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

Page 8 of 12 A highl y conservative chronic dietary (food and water) risk assessment was conducted for the proposed tolerance in/on sorghum of mefenpy r - diethyl as a safener. HED has no concern for the chronic dietary risk resulting from the new use on sorghum since the chronic dietary

exposure to mefenpy

r from food and drinking water results in an estimated risk that is <1% of the cPAD for the U.S. population and all regulated subgroups based on the new use pattern. IX. List of Attachments

• Chronic Food Onl y Residue Input File • Chronic Food Onl y Results File • Chronic Food and Water R esidue Input File • Chronic Food and Water Results FileMefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

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Attachment 1. Chronic Food Only Residue Input File U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for MEFENPYR - DIETHYL 1994 - 98 data Residue file: C: \ Documents and Settings \ ALEMAY \ My Documents \ Mefenpyr - diethyl \ Dietary Exposure \ DEEM Runs \ Mefenpyr_Chronic_Sorghum_Foodonly.R98 Adjust. #2 NOT used Analysis Date 09 - 16 - 2010 Residue file dated: 09 - 16 - 2010/09:12:40/8 Reference dose (RfD) = 0.51 mg/kg bw/day

-------------------------------------------------------------------------------- Food Crop Residue Adj.Factors Comment EPA Code Grp Food Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley - babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour - babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 1.000 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.100000 1.000 1.000 21000490 M Beef, liver 0.100000 1.000 1.000 21000491 M Beef, liver - babyfood 0.100000 1.000 1.000 23001700 M Go at, meat byproducts 0.100000 1.000 1.000 23001720 M Goat, kidney 0.100000 1.000 1.000 23001730 M Goat, liver 0.100000 1.000 1.000 25002920 M Pork, meat byprodu cts 0.100000 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 0.100000 1.000 1.000 25002950 M Pork, liver 0.100000 1.000 1.000 20003190 20 Rapeseed, oil 0.020000 1.000 1.000 20003191 20 Rapeseed, oil - babyfood 0.020000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.00 0 1.000 26003420 M Sheep, kidney 0.100000 1.000 1.000 26003430 M Sheep, liver 0.100000 1.000 1.000 15003440 15 Sorghum, grain 0.040000 1.000 1.000 N ew to Full comment: New tolerance 15003450 15 Sorghum, syrup 0.040000 1.000 1.000 New to Full comment: New tolerance 06003470 6 Soybean, seed 0.020000 1.000 1.000 06003480 6 Soybean, f lour 0.020000 1.000 1.000 06003481 6 Soybean, flour - babyfood 0.020000 1.000 1.000 06003490 6 Soybean, soy milk 0.020000 1.000 1.000 06003491 6 Soybean, soy milk - babyfood or in 0.020000 1.000 1.000 06003500 6 Soybean, oil 0.020000 1.000 1.000 06003501 6 Soybean, oil - babyfood 0.020000 1.000 1.000 15004010 15 Wheat, grain 0.05000 0 1.000 1.000 15004011 15 Wheat, grain - babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour - babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 1.000 1.000Mefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

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Attachment 2. Chronic Food Only Results File
U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for MEFENPYR - DIETHYL (1994 - 98 data) Residue file name: C: \ Documents and Settings \ ALEMAY \ My Document s \ Mefenpyr - diethyl \ Dietary Exposure \ DEEM Runs \ Mefenpyr_Chronic_Sorghum_Foodonly.R98 Adjustment factor #2 NOT used. Analysis Date 09 - 16 - 2010/09:13:46 Residue file dated: 09
- 16 - 2010/09:12:40/8 Reference do se (RfD, Chronic) = .51 mg/kg bw/day

=============================================================================== Total exposure by population subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.000105 0.0% U.S. Population (spring season) 0.000107 0.0% U.S. Population (summer season) 0.000102 0.0% U.S. Population (autumn season) 0.000104 0.0% U.S. Population (winter season) 0.000106 0.0% Northeast region 0.000109 0.0% Midwest region 0.000111 0.0% Southern region 0.000099 0.0% Western region 0.000104 0.0% Hispanics 0.000097 0.0% Non - hispanic whites 0.000106 0.0% Non - hispanic blacks 0.000103 0.0% Non - hisp/non
- w hite/non
- black 0.000103 0.0% All infants (< 1 year) 0.000067 0.0% Nursing infants 0.000030 0.0% Non - nursing infants 0.0 00081 0.0% Children 1 - 6 yrs 0.000234 0.0% Children 7 - 12 yrs 0.000159 0.0% Females 13 - 19 (not preg or nursing) 0.000089 0.0% Female s 20+ (not preg or nursing) 0.000072 0.0% Females 13 - 50 yrs 0.000083 0.0% Females 13+ (preg/not nursing) 0.000085 0.0% Females 13+ (nursing) 0.000093 0.0% Males 13 - 19 yrs 0.000113 0.0% Males 20+ yrs 0.000092 0.0% Seniors 55+ 0.000069 0.0% Children 1 - 2 yrs 0.000235 0.0% Children 3 - 5 yrs 0.000239 0.0% Children 6 - 12 yrs 0.000167 0.0% Youth 13 - 19 yrs 0.000101 0.0% Adults 20 - 49 yrs 0.000089 0.0% Adults 50+ yrs 0.000070 0.0% Females 13 - 49 yrs 0.000080 0.0%

-------------------------------------------------------------------------------Mefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

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Attachment 3. Chronic Food and Water Residue Input File U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for MEFENPYR - DIETHYL 1994 - 98 data Residue file: C: \ Documents and Settings \ ALEMAY \ My Documents \ Mefenpyr - diethyl \ DEEM Runs \ Mefenpyr_Chronic_Sorghum_FoodandWater.R98 Adjust. #2 NOT u sed Analysis Date 09 - 15 - 2010 Residue file dated: 09 - 15 - 2010/15:01:35/8 Reference dose (RfD) = 0.51 mg/kg bw/day

-------------------------------------------------------------------------------- Food Crop Re sidue Adj.Factors Comment EPA Code Grp Food Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ - ------ 15000250 15 Barley, pearled barley 0.050000 1.000 1.000 15000251 15 Barley, pearled barley - babyfood 0.050000 1.000 1.000 15000260 15 Barley, flour 0.050000 1.000 1.000 15000261 15 Barley, flour - babyfood 0.050000 1.000 1.000 15000270 15 Barley, bran 0.050000 1.000 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.100000 1.000 1.000 21000490 M Beef, liver 0.100000 1.000 1.000 21000491 M Beef, liver - babyfood 0.100000 1.000 1.000 23001700 M Goat, meat byproducts 0.100000 1.000 1.000 23001720 M Goat, kidney 0.100000 1.000 1.000 23001730 M Goat, liver 0.100000 1.000 1.000 25002920 M Pork, meat byproducts 0.100000 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 0.100000 1.000 1. 000 25002950 M Pork, liver 0.100000 1.000 1.000 20003190 20 Rapeseed, oil 0.020000 1.000 1.000 20003191 20 Rapeseed, oil - babyfood 0.020000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003420 M Sheep, kidney 0.100000 1.000 1.000 26003430 M Sheep, liver 0.100000 1.000 1.000 15003440 15 So rghum, grain 0.040000 1.000 1.000 New to Full comment: New tolerance 15003450 15 Sorghum, syrup 0.040000 1.000 1.000 New to Full comment: New tolerance 06003470 6 Soybean, seed 0.020000 1.000 1.000 06003480 6 Soybean, flour 0.020000 1.000 1.000 06003481 6 Soybean, flour - babyfood 0.020000 1.000 1.000 06003490 6 Soybean, soy milk 0.02000 0 1.000 1.000 06003491 6 Soybean, soy milk - babyfood or in 0.020000 1.000 1.000 06003500 6 Soybean, oil 0.020000 1.000 1.000 06003501 6 Soybean, oil - babyfood 0.020000 1.000 1 .000 86010000 O Water, direct, all sources 0.004000 1.000 1.000 86020000 O Water, indirect, all sources 0.004000 1.000 1.000 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain - babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour - babyfood 0.050000 1.000 1.000 15004030 15 Wheat, ger m 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.050000 1.000 1.000Mefenp yr - diethyl Dietary Exposure and Risk Assessment D 380767 PC Code: 811800

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Attachment 4. Chronic Food and Water Results File

U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for MEFENPYR - DIETHYL (1994 - 98 data) Residue file name: C: \ Documents and Settings \ ALEMAY \ My Documents \ Mefenpyr - diethyl \ DEEM Runs \ Mefenpyr_C hronic_Sorghum_FoodandWater.R98 Adjustment factor #2 NOT used. Analysis Date 09 - 15 - 2010/15:03:00 Residue file dated: 09
- 15 - 2010/15:01:35/8 Reference dose (RfD, Chronic) = .51 mg/kg bw/day

=============== ================================================================ Total exposure by population subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

---------- ---------------------------- ------------- --------------- U.S. Population (total) 0.000189 0.0% U.S. Population (spring season) 0.000190 0.0% U.S. Population (summer season) 0.000193 0.0% U.S. Population (autumn season) 0.000186 0.0% U.S. Population (winter season) 0.000187 0.0% Northeast region 0.000186 0.0% Midwest region 0.000196 0.0% Southern region 0.000179 0.0% Western region 0.000200 0.0% Hispanics 0.000193 0.0% Non - hispanic whites 0.000189 0.0% Non - hispanic blacks 0.000183 0.0% Non - hisp/non
- white/non
- black 0.000206 0.0% All infants (< 1 year) 0.000343 0.1% Nursing infants 0.000133 0.0% Non - nursing infants 0.000423 0.1% Children 1 - 6 yrs 0.000351 0.1% Children 7 - 12 yrs 0.000236 0.0% Females 13 - 19 (not preg or nursing) 0.000148 0.0% Females 20+ (not preg or nursing) 0.000157 0.0% Females 13 - 50 yrs 0.000165 0.0% Females 13+ (preg/not nursing) 0.000166 0.0% Females 13+ (nursing) 0.000210 0.0% Males 13 - 19 yrs 0.000175 0.0% Males 20+ yrs 0.000168 0.0% Seniors 55+ 0.000152 0.0% Children 1 - 2 yrs 0.0003 60 0.1% Children 3 - 5 yrs 0.000356 0.1% Children 6 - 12 yrs 0.000248 0.0% Youth 13 - 19 yrs 0.000162 0.0% Adults 20 - 49 yrs 0.000167 0.0% Adults 50+ yrs 0.000153 0.0% Females 13 - 49 yrs 0.000158 0.0%

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