Page 1 of 14 

### UNITED STA

**TES ENVIRONMENTA L PROTECTION A** **GENCY WA** **SHINGTON, D.C. 20460 OFFICE OF**  **CHEMICAL SAFETY AND POLLUTION PREVENTION** 



### MEMORANDUM **Date :**  Ju ly

11 , 2013 **SUBJECT: Fo**  **mesafen Sodium ,**  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment s for the Section 3 Registration Action on C antaloupe, C ucumber, P ea ( S ucculent), P umpkin, S ummer S quash, W inter S quash, W atermelon, S oybean ( S uccu lent) and L ima B ean ( S ucculent) **PC Code s**  **:** 123802, 123803 **DP Barcode s**  **:** D 410439, D410795 **Decision No s**  **.:** 467057 , 477271 **Registration No s**  **. :**  100 - 993 ; 100 - 1017 **Petition No s**  **.:** 2E806 1 , 3E8167 **Regulatory Action:**  Section 3 Registration **Risk A**  **ss essment Type:**  Dietary **Case No.:** NA **T XR No.:**  NA **CAS No.:** 72178 - 02 - 0 , 108731 - 70 - 0 **MRID No.:** NA **40 CFR:** §180. 433 

### FROM: Danette Drew, Chemist

Risk Assessment Branch V Health Effects Division ( HED, 7509P) **THROUGH:** Nancy

Dodd, Chemist Meheret Negussie, Chemist Dietary Exposure Science Advisory Council (DESAC) **TO:** Laura Nollen/ Barbara Madden , RM 05

Risk Integration, Minor Use & Emergency Response Branch Registration Divisio n (RD, 750 5 P) **Executive Summary** Acute and chronic aggregate dietary (f ood and drinking water ) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity

Intake Database (DEEM - FCID) Version 3.16 . This software uses 2003 - 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The analys es were conducted in support of a human - health risk assessment for the proposed Section 3 uses of fomesafen sodium (commonly called fomesafen) on cantaloupe, cucumber, pea (succulent),Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 2 of 14 

### pumpkin, summer squash, winter squash, watermelon, soy bean (succulent) and lima bean (succulent). This memorandum was reviewed b y two peer reviewers o f the DE SAC , per DESAC SOP 2012.1 . Acute and Chronic Dietary Exposure Assessment The assumptions of these unrefined acute and chronic assessments were tolerance - level residues, 100% crop treated, and default DEEM processing factors. Model - based e stimated drinking water concentrations (EDWCs) from the Environmental Fate and Effects Divis ion (EFED) were also included. The dietary

exposure analy ses in this assessme nt result in dietary risk estimates for food and drinking water that are below the Agency ’s level of concern for both acute and chronic dietary exposure s for all population subgroups. The acute exposure for food plus drinking water to the general U.S. popu lation and all population subgroups was <1% of the acute population adjusted dose (aPAD) at the 95 th 

### percentile of exposure. The chronic exposure for food plus drinking water to the general U.S. population is 32 % of the chronic population adjusted dose (cP AD). The subgroup with the highest chronic exposure and risk estimate is infants. For infants, the exposure for food plus drinking water was 0.00 19 15 mg/kg/day , which represents 77 % of the cPAD. Cancer Dietary Exposure Assessment The Cancer Assessment Review Committee (CARC) classified fomesafen as “Not likely to be carcinogenic to humans;” therefore, a cancer assessment was not performed. **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 that HED has concluded will result in no unreasonab le 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 uncertaint y or safet y factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure fro m Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: http://www.epa.gov/fedrgstr/EPA - PEST/2000/July /Day - 12/6061.pdf

; or see SOP 99.6 (20 - AUG 1999). The most recent dietary

risk assessment for fomesafen was conducted on 10/12/10 (A. LaMay , D382064 ).Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 3 of 14 

### II **. Residue Information**  Fomesafen sodium is a contact herbicide in the diphenylether chemical class and acts via inhibition of protoporphyrinogen oxidase (PPO). It is used to control broadleaf and grass weeds, as well as postemergenc e weeds in legumes and other crops . Tolerances for fomesafen residues are listed in 40 CFR §180.433. Currently tolerances are established for fomesafen acid in field soy beans, dry

beans, and snap (succulent) beans at 0.05 ppm and peppers (bell and non - bell), potatoes, tomatoes, and cotton gin by - products and cottonseed at 0.025 ppm. Inthe current petitions ( 2E8061, 3E8167 ), uses are proposed for fomesafen on cantaloupe, cucumber, pea (succulent), pumpkin, summer squash, winter squ ash, watermelon, so ybean (succulent) and lima bean (succulent). HED is recommending for tolerance levels of 0.025 ppm on cantaloupe, cucumber, pea (succulent), pumpkin, summer squash, winter squash and watermelon and 0.05 ppm on soy bean (succulent) and lim a bean (succulent) ( I. Encarnacion, D 407932 ). All crops with existing and proposed uses of fomesafen were considered in this assessment. The residue of concern for plant commodities and drinking water is fomesafen. The residues of concern in livestock commodities consists of fomesafen and its metabolites 5 - (2 - chloro - α,α,α trifluoro - p - tolyloxy) anthranilic acid and 5 - (2 - chloro - α,α,α - trifluoro - p - tol yl oxy ) -Nmethylsulfonylanthranilamide. However, based on the submitted livestock metab olism studies , HED concluded that the proposed/registered uses of fomesafen result in a 40 CFR §180.6(a)(3) situation for livestock commodities; i.e., there is no reasonable expectation of finite residues in livestock commodities. Tolerance - level residues and 100% crop treated were used for all commodities included in these assessments. Tolerance levels are based on non - detectable residues found in field trials (see Table 1 below) . The tomato and potato processing stud ies previously submitted w ere inadequate due to the lack of detectable residues in/on the raw commodity . Therefore, default tomato paste, dried tomato, tomato juice, and tomato puree , and dried potato concentration factors were used for these processed commodities. **Table 1**  **. Tolerance**  **Summary for Fo**  **me safen**  **. Comm**  **odity Proposed Tolerance**  **(ppm) HED**  **- Recommended** 

**Tolerance (ppm) Comments** 

**( correct commodity definition**  **)** Cantaloupe 0.025 0.025 Cucumber 0.025 0.025 Pea, succulent 0.025 0.025 Pum pkin 0.025 0.025 Squash, summer 0.025 0.025 Winter, Squash 0.025 0.025 Squash, winter Watermelon 0.025 0.025 Vegetable, soybean, succulent 0.05 0.05 Soybean, vegetable, succulent Lima, bean 0.05 0.05 Bean, lima, succulentFomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 4 of 14 

### The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010. In general, pesticide residues would not be expected to be found in fish unless the pesticide bio accumulates or has an aquatic use. To determine wheth er or not residues are present in fish, HED now routinely checks PDP monitoring data regardless of the pesticide’s uses and ph ys icochemical properties. However, PDP did not analy ze catfish samples for fomesafen . As a result, residues in fish were not inc luded in the assessment . **I I**  **I. Percent Crop Treated Information**  The acute and chronic assessments were both based on the assumption that 100% of all commodities with registered or proposed uses of f omesafen will be treated. **IV. Drinking Water Data** The drinking water residues used in the dietary risk assessment were provided by the EFED in the following memorandum: Revised Fomesafen Drinking W ater Assessment to Include IR - 4 Use on Lima Bean and Groundwater EDW Cs Using a Tier-I PRZM

- GW Model (D 412599 , H. Zhong , 6/24 /12 ) 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.” EFED recommended the Tier I PRZM - GW h ighest acute value of **51.8 μg/L**  and chronic value of **32.3 μg/L**  for ground water estimated drinking water concentrations ( EDWC s). These EDWCs were based on the highest proposed application rate for fomesafen (0.375 lb a.i./acre) . The ground water EDWCs wer e higher than the surface water EDWCs, which were based on Tier - II PRZM/EXAM modeling, and were therefore selected for use in the fomesafen dietary

assessment. The drinking water model s and their description s are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . **V. DEEM**  **- FCID Program and Consumption Information**  Fomesafen acute and chronic dietary exposure assessments were conducted using the DEEM FCID, Version 3.1 6 , which incorporates 2003 - 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - define d food commodities (e.g. , apples, peeled fruit - cooked; fresh or 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, consumpti on data are averaged for the entire U.S. population and within population subgroups . However , for acute exposure assessment , consumption data are retained as individual consumption events. Based on anal ys is of the 2003 - 2008 WWEIA consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 ye ars old.Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 5 of 14 

### For a 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 summed with the residue intake estimates for all other food/food forms on the commodity re sidue 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 an acute exposure assessment, individual one - day foo d 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., onl y those who reported eating relevant c ommodities/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 analy ses performed at all levels of refinem ent . However, for deterministic assessments , any significant differences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment. **VI .**  **Toxicological Information** The acute dietary

endpoint is based on decreased body weight and motor activity (horizontal and vertical activity

and time in central quadrant) in males observed in the acute neurotoxicity study in rats. The chronic dietary endpoint is based on hyalinization of the liver in males in the c hronic toxicity / carcinogenicit y study in rat . These endpoints are applicable to all populations including infants and children. The FQPA safety factor is reduced to 1X as there there is no evidence of increased susceptibility

in developing and young animals, an d there are no residual uncertainties concerning pre - or post - natal toxicity . The toxicity and exposure databases for fomesafen are complete. In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), the CARC classifie d fomesafen as “Not Likel y to be Carcinogenic to Humans.” This decision was based on the weight - of - evidence which supports activation of peroxisome proliferator activated receptor alpha (PPARα) as the mode of action for fomesafen - induced hepatocarcinogene sis in mice. The quantification of cancer risk is not required. A summary

of the endpoints and points of departure selected for dietary risk assessment may

be found in Table 2 below. **Table 2**  **. Summary of Toxicological Doses and Endpoints for Fom**  **esafe n for Use in Dietary Hum**  **an Health Risk Assessments**  **Exposure/ Scenario**  **Point of**

**Departure Uncertainty/FQPA** 

**Safety Factors RfD, PAD,** 

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects**Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 6 of 14 **Table 2**  **. Summary of Toxicological Doses and Endpoints for Fom**  **esafe n for Use in Dietary Hum**  **an Health Risk Assessments**  **Exposure/ Scenario**  **Point of**

**Departure Uncertainty/FQPA** 

**Safety Factors RfD, PAD,** 

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects** Ac ute Dietary (General Population, including Infants and Children) NOAEL =

100 mg/kg/day UF A = 10x

UF H = 10x FQPA SF = 1x Ac ute RfD =

1 mg/kg/day aPAD = 1 mg/kg/day Ac ute neurotoxicity test in rat

LOAEL = 250 mg/kg/day based on decreased body weight and motor activity (horizontal and vertical activity and time in central quadrant) in males Chronic Dietary (All Populations) NOAEL =

0.25 mg/kg/day UFA = 10x

UFH = 10x FQPA SF = 1x Chronic RfD

= 0.0025 mg/kg/day cPAD = 0.0025 mg/kg/day Chronic toxicity/ carcinogenicity in rat

LOAEL = 5 mg/kg/day based on hyalinization of the liver in males Cancer (oral, dermal, inhalation) Classification: The CARC classified f om esafen as “Not Likely to be Carcinogenic to Humans . ” 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 (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short - term study for long - term risk assessment. UF DB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 

### VII. **Results/Discussion** As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCI anal ys is estimates the dietary exposure of the U.S. population and various population subgroups. The dietary assessment results s ummarized in Table 2 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+ ye ars. Results of Acute Dietary

Exposure Analy si s All acute dietary

(food and drinking water) risk estimates are below the level of concern for the general U.S. population and all population subgroups assessed. The acute exposure for food plus drinking water to the general U.S. population and all popu lation subgroups was <1% of the aPAD at the 95 th 

### percentile of exposure. Results of Chronic Dietary Exposure Analy sis All chronic dietary

(food and drinking water) risk estimates are below the level of concern for the general U.S. p opulation and all population subgroups assessed . The chronic dietary risk estimate for the general U.S. population is 32 % of the cPAD. The population subgroup with theFomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 7 of 14 

### highest exposure is all infants (<1 ye ar old) at 0.00 1915 mg/kg/day , which utilized 77 % of the cPAD. **Table 3**  **. Summary of Dietary** (Food and Drinking Water) **Exposure and Risk for Fomesafen**  **. Population Subgroup**  **Acute Dietary (**  **95th Percentile)**  **Chronic Dietary Cancer**  **Dietary Exposure**  **(m g/kg/day)**  **% aPAD Dietary**  **Exposure (m**  **g/kg/day) % cPAD** * **Dietary Exposure**  **(m g/kg/day)**  **Risk** General U.S. Population 0.002 999 <1 0.000 787 32 **All Infants (<1 year old)** * 0.00 9060 <1 **0.00 19**  **15 77**  

### N/A N/A Children 1 - 2 y ears old 0.00 4827 <1 0.00 1267 51 Children 3 - 5 y ears old 0.00 3915 <1 0.00 1085 43 Children 6 - 12 y ears old 0.002 951 <1 0.000 755 30 Youth 13 - 19 y ears old 0.00 2455 <1 0.000 588 24 Adults 20 - 49 y ears old 0.00 2858 <1 0.000 766 31 Adults 50 - 99 years old 0.00 2597 <1 0.000 754 30 Females 13 - 49 y ears old 0.002 938 <1 0.000 760 30 *T he subpopulation with the highest risk estimate 

### VIII. **Characterization of Inputs/Outputs** HED has conducted a highly conservative, health protective assessment for the existing and proposed new uses of fomesafen sodium. Tolerance - level residues on foods along with 100% crop treated were used in the acute and chronic dietary exposure assessments . Inaddition, DEEM default processing factors were used. Drinking water estimates were based on a conservative modeling approach. Various refinements could be made to the assessments ; h owever, as there are no risk estimates of concern, n o refinements were incorporated. **IX. Conclusions**  Unrefined acute and chronic dietary (food and drinking water) exposure assessment s w ere performed for fo mesafen sodium which assumed tolerance - level residues and 100% crop treated. The dietary anal ys es for fomesafen result ed in dietary risk estimates that are below the Agency ’s level of concern for acute and chronic dietary exposure s . The acute exposure fo r food plus drinking water to the general U.S. population and all population subgroups was <1% of the aPAD at the 95 th 

### percentile of exposure. The chronic exposure for food plus drinking water to the general U.S. population is 32 % of the cPAD . The subgroup with the highest chronic exposure and risk estimate is infants (<1 year old) at 0.00 1915 mg/kg/day , which represents 77 % of the cPAD. HED is confident that th is dietary assessment does not underestimate risk to the general U.S. population or any population subgroup .Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 8 of 14 

### X. **List of Attachments** Attachment 1: DEEM - FCIDTM Acute Residue Input F ile. Attachment 2: DEEM - FCIDTM Acute Results F ile. Attachment 3: DEEM - FCIDTM Chronic Residue Input F ile. Attachment 4: DEEM - FCIDTM Chronic Results F ile.Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 9 of 14 

### Attachment 1: DEEM **- FCIDTM Acute Residue Input**  **F ile.**  Filename: C: \ Documents and Settings \ ddrew \ My Documents \ DEEM_Version_3_16 \ ResidueFiles \ fomesafen acute12.r08 Chemical: Fomesafen sodium RfD(Chronic): .0025 mg/kg bw/day NOEL(Chronic): .25 mg/kg bw/day RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day Date created/last modified: 06 - 20 - 2013/13:43:34 Program ver. 3.16, 03 - 08 - d Comment: with surface water EDWC

-------------------------------------------------- --------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- -- ---- ------ ------- 0103296000 1C Potato, chips 0.025000 1.000 1.000 0103297000 1C Potato, dry (granules/ flakes) 0.025000 6.500 1.000 0103297001 1C Potato, dry (granules/ flakes) - b 0.025000 6.500 1.000 0103 298000 1C Potato, flour 0.025000 6.500 1.000 0103298001 1C Potato, flour - babyfood 0.025000 6.500 1.000 0103299000 1C Potato, tuber, w/peel 0.025000 1.000 1.000 0103299001 1C Potato, tuber , w/peel - babyfood 0.025000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.025000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 0.025000 1.000 1.000 0600347000 6 Soybean, seed 0.0 50000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 06 00350001 6 Soybean, oil - babyfood 0.050000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.050000 1.000 1.000 0601043001 6A Bean, snap, succulent - babyfood 0.050000 1.000 1.000 0601349500 6AB Soybean, ve getable 0.050000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.050000 1.000 1.000 0602255000 6B Pea, succulent 0.025000 1.000 1.000 0602255001 6B Pea, succulent - babyfood 0 .025000 1.000 1.000 0603030000 6C Bean, black, seed 0.050000 1.000 1.000 0603032000 6C Bean, broad, seed 0.050000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.050000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.050000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.050000 1.000 1.000 0603038000 6C Bean, lima, seed 0.050000 1.000 1.000 0603039000 6C Bean, mun g, seed 0.050000 1.000 1.000 0603040000 6C Bean, navy, seed 0.050000 1.000 1.000 0603041000 6C Bean, pink, seed 0.050000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.050000 1.000 1.000 0603098000 6C Chickpea, seed 0.050000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.050000 1.000 1.000 0603099000 6C Chickpea, flour 0.050000 1.000 1.000 0603182000 6C Guar, seed 0.050000 1.000 1.000 0603182001 6C Guar, seed - babyfood 0.050000 1.000 1.000 0603203000 6C Lentil, seed 0.050000 1.000 1.000 0603256000 6C Pea, dr y 0.050000 1.000 1.000 0603256001 6C Pea, dry - babyfood 0.050000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.050000 1.000 1.000 0603348000 6C Soybean, flour 0.050000 1.000 1.000 0603348001 6C Soybean, flour - babyfood 0.050000 1.000 1.000 0801374000 8A Tomatillo 0.025000 1.000 1.000 0801375000 8A Tomato 0.025000 1.000 1.00 0 0801375001 8A Tomato - babyfood 0.025000 1.000 1.000 0801376000 8A Tomato, paste 0.025000 5.400 1.000 0801376001 8A Tomato, paste - babyfood 0.025000 5.400 1.000 0801377000 8A Tomat o, puree 0.025000 3.300 1.000 0801377001 8A Tomato, puree - babyfood 0.025000 3.300 1.000 0801378000 8A Tomato, dried 0.025000 14.300 1.000 0801378001 8A Tomato, dried - babyfood 0.025000 14.300 1.000 0801379000 8A Tomato, juice 0.025000 1.500 1.000 0801380000 8A Tomato, Tree 0.025000 1.000 1.000 0802270000 8B Pepper, bell 0.025000 1.000 1.000 0802270001 8B Pepper, bell - babyfood 0.025000 1.000 1.000 0802271000 8B Pepper, bell, dried 0.025000 1.000 1.000Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 10 of 14 0802271001 8B Pepper, b ell, dried - babyfood 0.025000 1.000 1.000 0802272000 8BC Pepper, nonbell 0.025000 1.000 1.000 0802272001 8BC Pepper, nonbell - babyfood 0.025000 1.000 1.000 0802273000 8BC Pepper, nonbell, dried 0.025000 1.000 1.000 0901075000 9A Cantaloupe 0.025000 1.000 1.000 0901399000 9A Watermelon 0.025000 1.000 1.000 0901400000 9A Watermelon, juice 0.025000 1.000 1.000 0902135000 9B Cucumber 0.025000 1.000 1.000 0902308000 9B Pumpkin 0.025000 1.000 1.000 0902309000 9B Pumpkin, seed 0.025000 1.000 1.000 0902356000 9B Squash, summer 0.025000 1.000 1.000 0902356001 9B Squash, summer - babyfood 0.025000 1.000 1.000 0902357000 9B Squash, winter 0.025000 1.000 1.000 0902357001 9B Squash, winter - babyfood 0.025000 1.000 1.000 2003128000 20C Cottonseed, oil 0.025000 1.000 1.000 2003128001 20C Cottonseed, oil - babyfood 0.025000 1.000 1.000 8601000000 86A Water, direct, all sources 0.051800 1.000 1.00 0 8602000000 86B Water, indirect, all sources 0.051800 1.000 1.000Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 11 of 14 

### Attachment 2: DEEM **- FCIDTM Acute Results**  **F ile.**  U.S. EPA Ver. 3.16, 03 - 08 - d DEEM - FCID ACUTE Analysis for FOMESAFEN SODIUM NHANES 2003 - 2008 2 - Day Residue file: fomesafen acute12.r08 Adjustment factor #2 NOT used. Analysis Date: 06 - 20 - 2013/13:46:35 Residue file dated: 06 - 20 - 2013/13:43:34 NOEL (Acute) = 100.000000 m g/kg body - wt/day RAC/FF intake summed over 24 hours Run Comment: "with surface water EDWC"

=============================================================================== Summary calculations -- per capita:

--- 95th Percentile ---- --- 99th Percentile ---- --- 99.9th Percentile ---- Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.002999 0.30 33349 0.0 04871 0.49 20531 0.009056 0.91 11042 All Infants: 0.009060 0.91 11037 0.012121 1.21 8250 0.017781 1.78 5623 Children 1 - 2: 0.004827 0.48 20715 0.007006 0.70 14272 0.016315 1.63 6129 Childre n 3 - 5: 0.003915 0.39 25539 0.005715 0.57 17498 0.009036 0.90 11067 Children 6 - 12: 0.002951 0.30 33891 0.004553 0.46 21962 0.006963 0.70 14361 Youth 13 - 19: 0.002455 0.25 40733 0.004031 0.40 24807 0.006020 0.60 16610 Adults 20 - 49: 0.002858 0.29 34984 0.004247 0.42 23544 0.006065 0.61 16487 Adults 50 - 99: 0.002597 0.26 38503 0.003921 0.39 25502 0.006049 0.60 16531 Female 13 - 49: 0.002938 0.29 34035 0.004253 0.43 23513 0.005965 0.60 16765Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 12 of 14 

### Attachment 3: DEEM **- FCIDTM Chronic Residue Input**  **F ile.**  Filename: C: \ Documents and Settings \ ddrew \ My Documents \ DEEM_Version_3_16 \ ResidueFiles \ fomesafen chronic12.r08 Chemical: Fomesafen sodium RfD(Chronic): .0025 mg/kg bw/day NOEL(Chronic): .25 mg/kg bw/day RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day Date created/last modified: 06 - 20 - 2013/ 13:36:32 Program ver. 3.16, 03 - 08 - d Comment: with surface water EDWC

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code G rp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 0103296000 1C Potato, chips 0.025000 1.000 1.000 0103297000 1C Potato, dry (gran ules/ flakes) 0.025000 6.500 1.000 0103297001 1C Potato, dry (granules/ flakes) - b 0.025000 6.500 1.000 0103298000 1C Potato, flour 0.025000 6.500 1.000 0103298001 1C Potato, flour - babyfood 0.02500 0 6.500 1.000 0103299000 1C Potato, tuber, w/peel 0.025000 1.000 1.000 0103299001 1C Potato, tuber, w/peel - babyfood 0.025000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.025000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 0.025000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 0600350001 6 Soybean, oil - babyfood 0.050000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.050000 1.000 1.000 0601043001 6A Bean, snap, succulent - babyfood 0.050000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.050000 1.000 1.000 0602255000 6B Pea, succulent 0.025000 1.000 1.000 0602255001 6B Pea, succulent - babyfood 0.025000 1.000 1.000 0603030000 6C Bean, black, seed 0.050000 1.000 1.000 0603032000 6C Bean, b road, seed 0.050000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.050000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.050000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.050000 1.000 1.000 0603038000 6C Bean, lima, seed 0.050000 1.000 1.000 0603039000 6C Bean, mung, seed 0.050000 1.000 1.000 0603040000 6C Bean, navy, seed 0.050000 1.000 1.00 0 0603041000 6C Bean, pink, seed 0.050000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.050000 1.000 1.000 0603098000 6C Chickpea, seed 0.050000 1.000 1.000 0603098001 6C Chick pea, seed - babyfood 0.050000 1.000 1.000 0603099000 6C Chickpea, flour 0.050000 1.000 1.000 0603182000 6C Guar, seed 0.050000 1.000 1.000 0603182001 6C Guar, seed - babyfood 0.050000 1.000 1.000 0603203000 6C Lentil, seed 0.050000 1.000 1.000 0603256000 6C Pea, dry 0.050000 1.000 1.000 0603256001 6C Pea, dry - babyfood 0.050000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.050000 1.000 1.000 0603348000 6C Soybean, flour 0.050000 1.000 1.000 0603348001 6C Soybean, flour - babyfood 0.050000 1.000 1.000 0801374000 8A Tomatillo 0.025000 1.000 1.000 0801375000 8A Tomato 0.025000 1.000 1.000 0801375001 8A Tomato - babyfood 0.025000 1.000 1.000 0801376000 8A Tomato, paste 0.025000 5.400 1.000 0801376001 8A Tomato, paste - babyfood 0.025000 5.400 1.000 0801377000 8A Tomato, puree 0.025000 3.300 1.000 0801377001 8A Tomato, puree - babyfood 0.025000 3.300 1.000 0801378000 8A Tomato, dried 0.025000 14.300 1.000 0801378001 8A Tomato, dried - babyfood 0.025000 14.300 1.000 0801379000 8A Tomato, juice 0.025000 1.500 1.000 0801380000 8A Tomato, Tree 0.025000 1.000 1.000 0802270000 8B Pepper, bell 0.025000 1.000 1.000 0802270001 8B Pepper, bell - babyfood 0.025000 1.000 1.00 0 0802271000 8B Pepper, bell, dried 0.025000 1.000 1.000Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 13 of 14 0802271001 8B Pepper, bell, dried - babyfood 0.025000 1.000 1.000 0802272000 8BC Pepper, nonbell 0.025000 1.000 1.000 0802272001 8BC Peppe r, nonbell - babyfood 0.025000 1.000 1.000 0802273000 8BC Pepper, nonbell, dried 0.025000 1.000 1.000 0901075000 9A Cantaloupe 0.025000 1.000 1.000 0901399000 9A Watermelon 0.025000 1.000 1.000 0901400000 9A Watermelon, juice 0.025000 1.000 1.000 0902135000 9B Cucumber 0.025000 1.000 1.000 0902308000 9B Pumpkin 0.025000 1.000 1.000 0902309000 9B Pumpkin, seed 0.025000 1.000 1.000 0902356000 9B Squash, summer 0.025000 1.000 1.000 0902356001 9B Squash, s ummer - babyfood 0.025000 1.000 1.000 0902357000 9B Squash, winter 0.025000 1.000 1.000 0902357001 9B Squash, winter - babyfood 0.025000 1.000 1.000 2003128000 20C Cottonseed, oil 0.025000 1.000 1.000 2003128001 20C Cottonseed, oil - babyfood 0.025000 1.000 1.000 8601000000 86A Water, direct, all sources 0.032300 1.000 1.000 8602000000 86B Water, indirect, all sources 0.032300 1.000 1.000Fomesafen Sodium Dietary Exposure and Risk Assessment DP Number: D410439, D410795

Page 14 of 14 

### Attachment 4: DEEM **- FCIDTM Chronic Results**  **F ile.**  U.S. EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for FOMESAFEN SODIUM NHANES 2003 - 2008 2 - day Residue file name: C: \ Documents and Settings \ ddrew \ My Documents \ DEEM_Version_3_16 \ ResidueFiles \ fomesafen chronic12.r08 Adjustment factor #2 NOT used. Analysis Date 06 - 20 - 2013/13:37:46 Residue file dated: 06 - 20 - 2013/13:36:32 Reference dose (RfD, Chronic) = .0025 mg/kg bw/day COMMENT 1: with surface water EDWC

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

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

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

-------------------------------------- ------------- ---------------- Total US Population 0.000787 31.5% Hispanic 0.000768 30.7% Non - Hisp - White 0.000805 32.2% Non - Hisp - Black 0.000659 26.4% Non - Hisp - Other 0.000902 36.1% Nursing Infants 0.000702 28.1% Non - Nursing Infants 0.002457 98.3% Female 13+ PREG 0.000 744 29.7% Children 1 - 6 0.001133 45.3% Children 7 - 12 0.000715 28.6% Male 13 - 19 0.000565 22.6% Female 13 - 19/NP 0.000611 24.4% Male 20+ 0.000722 28.9% Female 20+/NP 0.000797 31.9% Seniors 55+ 0.000740 29.6% All Infants 0.001915 76.6% Female 13 - 50 0.000760 30.4% Children 1 - 2 0.001267 50.7% Chi ldren 3 - 5 0.001085 43.4% Children 6 - 12 0.000755 30.2% Youth 13 - 19 0.000588 23.5% Adults 20 - 49 0.000766 30.6% Adults 50 - 99 0.000754 30.1% Female 13 - 49 0.000760 30.4%