Dimethenamid/Dim et henamid

- P Dietary Exposure and Risk Assessment DP Number 418116



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460



### MEMORANDUM

Date: August 28, 2014 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Dimethenamid/Dimethenamid-P. Acute and C hronic Aggregate Dietary (Food and Drinking Water) Ex posure and Risk Assessments for Pr o posed New Use on Cotto n see d Subgroup 20C.



### PC Code: 12905l/1 2005 1 

### Decision No.: 482296 

### Petition No.: 3F 8197 

### Risk Assessment Type: Dietary 

### TXR No.: Not Applicable 

### MRID No.: Not Applicable 

### DP Barcode : D418116 

### Registration No.: 7969-156 

### Regulatory Action: Amended Section 3 Registration 

### Case No.: 7223 

### CAS No.: 87674-68-8/163515-14-8 

### 40 CFR: 

### § 1 80.464



### FROM: Bonnie Cropp-Kohlligian, Environmental

# Scientis~~ (',_

...,...._

# ~**;~** Ri sk Assessment Bran ch IV (RA BIV) '-"'\\"" 

## (J

. . Health Effe cts Division (HED) (7509 r:h /J 

# 1/vJ 

# r

THROUGH f'Su s an V. Hummel, Senior Chemist ( 

# }'J6--J

. 

# !J11t.

RABIV

, HED (7509P)**~** 

### and Thurston Morton, Senior Chemist David Hrdy, Senior Biologist 

# ().It, Dietary Exposure Science

## Adv~~

TO: E. Kraft/K. Da v i s 

### (RM 25) Herbicide Branch Registration Division (7505P)



### Executive Summary SAC), HED (7509P)

Acute and chronic aggregate dietary (foo d and drinking water) expo s ure and risk assessments

were conducted using the Dietary Exposure Eval uation Model software with the Foo d 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) Nat ional Health and Nutrition Examination Survey, What We Eat in America, (NHANES / WWEIA). The analyses

were conducted in support of a human health risk assessment for the proposed Section 3 use of

Page 1 of 13Dimethenamid/Dimethenamid-P Dietary Exposure and Risk Assessment DP Number: 418116



### dimethenamid-P on cottonseed subgroup 20C. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Both the acute and chronic assessments are conservative and incorporated tolerance level residues, assume 100% crop treated and use default processing factors. Estimated drinking water concentrations (EDWCs) used in the assessments were generated using T i er I modeling.

For the acute assessment, aggregate dietary (food and drinking water) exposures are below HED's le ve l of concern (<100% aPAD) at the 95th percentile of exposure for all popu lation

s ubgroups. The acute dietary exposure at the 95th percentile of exposure is estimated at 0.008399 mg/kg/day for the overall U.S. population, eq uival en t to < 1% of the aPAD. The population subgroup with the highest estimated acute dietary exposure is A ll Infants < 1 year of age, with an estimated exposure at the 95 1 

### h percentile of 0.026253 mg/kg/day, equivalent to 1.3% ofthe aPAD.

For the chronic assessment, aggregate dietary (food and drinking water) exposures are below HED's l eve l of concern (<100% cPAD) for all population subgroups. The chronic dietary
exposure is estimated at 0.003241 mg/kg/day for the general U.S. population, equivalent to 6.5% ofthe cPAD. The population s ubgroup with the highes t estimated chronic dietary exposure is All Infants <1 year of age, with an estimated exposure of 0.008326 mg/kg/day, equivalent to 17% of the cPAD.

Dimethenamid is classified as a Group C chemical (possible human carcinogen). Cancer dietary risk concerns due to long-term consumption of dimethenamid r esi du es are adequately addressed by the chronic dietary exposure analysis using the reference dose; therefore, a separa te cancer dietary exposure analysis 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 unreasonable adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is eq uiva lent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 1 00% of the PAD. References that discuss the acute and chronic risk assessments in

more detail are available on the EPA/pesticides web site: "Availab le Info rmation on Assessing Exposure from Pesticides, A User's G uid e," 21-JUN-2000, web link: h ttp://www.epa.gov/fedrgstr/EPA-PEST/2000/Ju ly /Day-12/606l.pdf; or see SOP 99.6 (20-AUG1999).

The most recent dietary risk assessment for dimethenamid/dimethenamid-P was conducted by B r eann Hanson (9/26/07, D341975).

Page 2 of13Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 3 of 13 II. Residue Information

Dimethenamid is an equal part mixture of the S

- and R

- isomers (50:50, S:R); whereas, dimethenamid

- P is enriched in the biologically active S

- isomer (90:10, S:R).

Hereafter in this document, bot h mixtures may be referred to as dimethenamid and references to dimethenamid should be understood to also apply to dimethenamid

- P

.

Plants: For the purposes of existing/proposes uses , t h e nature of the residue in plants is adequately understood based on available soybean, corn and sugar beet metabolism studies. The residue of concern for purposes of the tolerance expression and risk assessment is parent only

. Tolerances are currently established unde r 40 CFR §180.464 (a) and (c) for residues of dimethenamid, 1( RS )

- 2

- chloro

- N

- [(1

- methyl

- 2

- methoxy)ethyl]

- N

- (2,4

- dimethylthien

- 3

- yl)acetamide, applied as either the 90:10 or 50:50 S:R isomers in/on numerous crop commodities ranging from 0.01 ppm to 2.5 ppm. Now , under PP#3F8197, HED is recommending in favor of establishing tolerances in/on cottonseed subgroup 20C and cotton, gin byproducts at 0.01 ppm and 1.5 ppm, respectively. The enforcement/data

- collection methods are not enantiomer specific.

The curre nt dietary analyses are based on the established/recommended tolerances for residues of dimethenamid in/on the food crops/commodities which are listed below in Table 1. These tolerances would apply to dimethenamid and/or dimethenamid

- P

. [Note: Livesto ck feed crops/commodities are excluded from this list.]

Table 1

. Residue Summary for Dimethenamid/Dimethenamid

- P excluding Livestock Feed Crops/Commodities

.

Commodity Established Tolerance (ppm) Recommended

Tolerance (s) Under Current Petition (ppm) Comments

Bean, dry, seed 0.01

-- Beet, garden, roots 0.01

-- Beet, garden, tops 0.01

-- Beet, sugar, molasses 0.01

-- Beet, sugar, roots 0.01

-- Beet, sugar, tops 0.01

-- Corn, field, grain 0.01

-- Corn, pop, grain 0.01

-- Corn, sweet, kernel plus cob w/husks removed 0.01

--
Cottonseed subgroup 20C

-- 0.01 Crops in this su b group include: cottonseed; cultivars, varieties, and/or hybrids of these. Garlic 0.0 1

-- Under §180.1(g) this tolerance also applies to great headed garlic and serpent garlic. Hops, dried cones 0.0 5

-- Horseradish 0. 01

-- Leek 0.0 1

-- Onion, bulb 0.0 1

-- Under §180.1(g) this tolerance also applies to garlic; great headed garlic; serpent garlic;Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 4 of 13 Table 1

. Residue Summary for Dimethenamid/Dimethenamid

- P excluding Livestock Feed Crops/Commodities

.

Commodity Established Tolerance (ppm) Recommended

Tolerance (s) Under Current Petition (ppm) Comments

Chinese onion; pearl onion; potato onion; and shallot, bulb. Onion, green 0.01

-- Under §180.1(g) this tolerance also applies to lady's leek; leek; wild leek; Beltsville bunching onion; fresh onion; tree onion, tops; Welsh onion; and shallot, fresh leaves. Onion, Welsh 0.0 1

-- Peanut 0.0 1

-- Pumpkin 0.01

-- Tolerance with regional restriction established under 40 CFR 180.464(c). Radish, roots 0. 01

-- Radish, tops 0. 01

-- Rutabaga, roots 0.0 1

-- Rutabaga, tops 0. 1

-- Shallot, bulb 0.01

-- Shallot, fresh leaves 0.01

-- Squash, winter 0.01

-- Tolerance with regional restriction established under 40 CFR 180.464(c). Sorghum, grain, grain 0.01

-- Under §180.1(g) this tolerance also applies to Sorghum spp. [sorghum, grain, sudangrass (seed crop), and hybrids of these grown for its seed]. Soybean, seed 0.01

-- Turnip, greens 0.1

-- Under §180.1(g) this tolerance also applies to broccoli raab (raab, raab salad), hanover salad, turnip tops (turnip greens). Turnip, roots 0.01

-- Turnip, tops 0.1

-- Vegetable, tuberous and corm, subgroup 1 C 0.0 1

-- Crops in this subgroup include: arracacha; arrowroot; artichoke, Chinese; artichoke, Jerusalem; canna, edible; cassava, bitter and sweet; chayote (root); chufa; dasheen; ginger; leren; potato; sweet potato; tanier; turmeric; yam bean; yam, true.



### Liv estock : HED ha s determined that there is no reasonable expectation of finite residues of

concern in livestock commodities (40 CFR §180.6(a)(3))

. Drinking Water: In laboratory studies, two degradates of significance, dimethenamid oxanilic acid (M23 ; also referred to as the dimethenamid

- OA degradate ) and dimethenamid ethanesulfonic acid (M27; also referred to as the dimethenamid

- ESA degradate) were formed through aerobic soil metabolism at up to 14.8% and 9% of the applied radioactivity, respectively. Thr ee other major degradates, the dechlorinated parent ( M3 ), the methyl sulfone derivative of M3 (M10 ) and the methyl sulfoxide derivative of M3 (M13), w ere formed through anaerobic aquatic metabolism at levels up to 20.6%, 9.8%, and 12.4% of the applied radi oactivity

,Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 5 of 13 respectively. Although M3, M10, and M13 are major degradates, they are formed only through anaerobic aquatic metabolism, which is not a major pathway for drinking water exposure.

USGS National Water

- Quality Assessment (NAWQA) Program Dat a co nducted monitoring for dimethenamid and its d egradates

, dimethenamid

- E SA and dimethenamid

- OA

, in surface

, treated and ground water s

. Dimethenamid was detected in surface water and treated water but not in groundwater. The dimethenamid

- ESA and dimethenamid

- OA degradates were detected in surface water and groundwater but not treated water. In ground water, the degradates were detect ed at higher concentrations and frequenc ies of detection than dimethenamid.

USDA PDP (2008

- 2012) also conducted mo nitoring for dimethenamid and its degradates

, dimethenamid

- ESA and dimethenamid

- OA

, in untreated, treated and ground water s

. Dimethenamid and the degradates were detected . As with the USGS NAWQA monitoring data, the degradates were detected in groundwate r at higher concentrations and frequencies of detection than dimethenamid.

In previous risk assessment only the parent was considered a residue of concern in drinking water; however, t he current risk assessment team has determined that the residues of con cern in drinking water are dimethenamid and its degradates, dimethenamid e thanesulfonic acid ( dimethenamid

- ESA) and dimethenamid oxanilic acid ( dimethenamid

- OA). Although the degradates appear to be less toxic than parent (email from R. Kent to B. Cropp

- K ohlligian dated 5/22/14) , they are included as residues of concern since they were identified as potentially significant degradates in the available fate data and found in greater abundance than the parent in some of the water monitoring studies.

Fish: N o tolerances are currently established for residues of dimethenamid or dimethenamid

- P in fish. The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010. Over this 3

- year period, PDP analyzed 1479 samples of ca tfish for dimethenamid residues. None of the samples contained detectable residues of dimethenamid. As a result, residues in fish were not included in the assessment.

I I I. Percent Crop Treated Information

The acute and chronic assessments are based on the assumption that 100% of all commodities with tolerances will be treated.Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 6 of 13 IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in a drinking water assessment (DWA; D 422167 , M. Biscoe

, 8/14 /14) entitled : “ Dimethenamid

- P: ADDENDUM Drinking Water Exposure Assessment for Existing Ornamental and Green Onion Uses and the Proposed Cotton Use. ” Estimated Drinking Water Concentrations (EDWCs) f or dimethenamid were calculated for the parent compound plus the dimethenamid ethanesulfonic acid ( dimethenamid

- ESA) and dimethenamid oxanilic acid ( dimethenamid

- OA) degradates. These estimated drinking w ater concentrations (EDWCs) were incorporated directly into this dietary assessment in the DEEM

FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

EFED generated the surface water EDWCs using the Surface Wate r Concentration Calculator (SWCC) and groundwater EDWCs were generated using Pesticide Root Zone M odel for Ground Water (PRZM

- GW). EDWCs were derived based on the maximum registered use rate ( ornamentals 3.0 lb ai/A ) , the maximum use rate on green onion ( i.e., t he scenario that resulted in the highest E DWCs in prior D WA ) and the proposed use on cotton ( 1.45 lb ai/A )

.

The maximum EDWCs calculated in this assessment are shown in Table 2 . In surface water, the highest estimated peak (acute) concentration is 73 μg/L, the highest estimated 1

- in

- 10 year annual average concentration is 27 μg/L, and the highest estimated 30

- year annual average concentration is 1 6 μg/L. In groundwater, the estimated peak (acute) concentration is 15 3 μg/L, and the estimated post

- breakthrough average (chronic) concentration is 1 40 μg/L. Because the maximum acute (groundwater 15 3 μ g/L) and chronic (groundwater 1 40 μ g/L) EDWCs were so close, the maximum EDWC in groundwater, 15 3 μ g/L

, w as used in both the acute and chronic dietary assessments to estimate residues in drinking water.

Table 2. Maximum estimated drinking water concentrations (EDWCs) in parts per billion (μg/L) for di methenamid and its degradates, dimethenamid

- ESA and di methenamid

- OA, for use in the dietary risk

assess ments. Drinking Water Source (model) [Tier] Model Scenario &

Application Method Acute Chronic Cancer μg/L

Surface Water ( SWCC ) [Tier 2] New Jersey Nursery

(Ornamentals) Ground Application Peak 1

- in

- 10 Year Chronic

1

- in

- 10 Year 30

- year Annual

Average

73 27 16

Groundwater (PRZM

- GW 30

- year simulation) [Tier 1] Wisconsin Corn

(Ornamentals) Peak Post

- Breakthrough Average

15 3 140



### The drinking water model s and t heir description s are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 7 of 13 V. DEEM

- FCID Program and Consumption Information

Dimethenamid and dimethenamid

- P acute and chronic dietary exposure assessments were conducted using the DEEM

- FCID, Version 3.16 , 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 t wo 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
trans lation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups

. However , for acute exposure assessment

, consumption data are retained as in dividual consumption events. Based on analysis of the 2003

- 2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the g eneral 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

- 99 years old.

For an acute exposure assessment, 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

- c apita (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 a nalyses performed at all levels of refinement . However, for deterministic a ssessments , any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment. For a chronic dietary exposure assessment, an estimate of the residue level in each food or food

form (e.g., oran ge 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 r esidue 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 popul ation subgroup.

VI. Toxicological Information

HED evaluated the toxicology data base for dimethenamid and dimethenamid

- P and selected doses and endpoints for dietary risk assessments provided in Table 3. Details are discussed in the forthcoming risk as sessment (D418118).Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 8 of 13 Table 3. Summary of Toxicological Doses and Endpoints for Use in Human Health Risk Assessments

Exposure/ Scenario Point of

Departure ( mg/kg/day) Safety Factors POD for Risk Assessment (mg/kg/day) Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children) NOAEL = 200 UF A = 10x UF H =10x FQPA SF= 1x aRfD = 2.0

aPAD = 2.0 L OAEL = 600 mg/kg from ACN study

based on lacrimation, salivation, irregular and accelerated respiration, slight tremors, reduced exploration, unsteady gait, significantly reduced rearing (females) and strongly constricted pupils (males)

Acute Dietary (Females 13

- 49 years of age) NOAEL = 75 UF A = 10x UF H =10x FQPA SF= 1x aRfD = 0.75

aPAD = 0.75 Developmental toxicity study in rabbits

Maternal; LOAEL = 150 mg/kg/day based on abortions and decreased body weight gain and food consumption. Developmental; LOAEL = 150 mg/kg/day based on post

- implantation loss

Chronic Dietary (All Populations) NOAEL= 5 UF A = 10x UF H =10x FQPA SF= 1x cRfD = 0.05

cPAD = 0.05 Chronic/carcinogenicity study in rats

LOAEL = M/F; 36/49 mg/kg/day based on decreased body weight and body weight gain in both sexes, increased food conversion ratios in females, and increased microscopic hepatic lesions in both sexes. Cancer (oral, dermal, inhalation) “C” P ossible human carcinogen. The cRfD is considered protective of the cancer effects.

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 f rom 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 acc ount 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. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.



### II. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The D EEM

- FCID TM analyses estimate the dietary exposure of the U.S. population and various subgroups including the gene ral 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

- 99 years old. The acute and chronic dietary exposure analyses are reported in Table 4

.

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

- P

.

Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Cancer
Dietary Exposure (mg/kg/day) % aPAD* Dietary Exposure (mg/kg/day) % cPAD* Dietary Exposure (mg/kg/day) Risk

General U.S. Population 0.008399 <1 0.00 3241 6. 5

N/A All Infants (<1 year old) 0.0 26253 1 .3 0.00 8326 1 7
Children 1

- 2 years old 0.013042 <1 0.00 4710 9. 4
Children 3

- 5 years old 0.010635 <1 0.00 3980 8.0Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 9 of 13 Table 4 . Summary of Dietary (Food and Drinking Water) Exposure and Risk for Dimethenamid/Dimethenamid

- P

.

Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Cancer
Dietary Exposure (mg/kg/day) % aPAD* Dietary Exposure (mg/kg/day) % cPAD* Dietary Exposure (mg/kg/day) Risk

Children 6

- 12 years old 0.008023 <1 0.00 2868 5.7
Youth 13

- 19 years old 0.006982 <1 0.00 2373 4.7
Adults 20

- 49 years old 0.008253 <1 0.00 3228 6. 5
Adults 50

- 99 years old 0.007364 <1 0.003186 6. 4
Females 13

- 49 years old 0.0 08361 1.1 0.003214 6. 4



### VIII. Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk analyses are based on tolerance

- level residues, 100% crop treated assumptions, and default processing factors. Various refinements could be made to the assessments. Howev er, as there are no risk estimates of concern, no refinements were incorporated.

IX. Conclusions

C onservative acute and chronic dietary (food and drinking water) exposure analys es were performed for the general U.S. population and various population sub groups. The acute and chronic risk estimates are not of concern. HED is confident the acute and chronic dietary exposures to dimethenamid/dimethenamid

- P are not underestimated.

For the acute assessment, aggregate dietary (food and drinking water) exposu res are below HED’s level of concern (<100% aPAD) at the 9 5 th 

### percentile of exposure for all population subgroups. The acute dietary exposure at the 9 5 th 

### percentile of exposure is estimated at 0.0 0 8399 mg/kg/day for the overall U.S. population, equivalent to <1 % of the aPAD. The population subgroup with the highest estimated acute dietary exposure is All Infants <1 year of age , with an estimated exposure at the 9 5 th 

### percentile of 0.0 26253 mg/kg/day, eq uivalent to 1 .3 % of the aPAD.

For the chronic assessment, aggregate dietary (food and drinking water) exposures are below HED’s level of concern ( <100% c PAD) for all population subgroups. The chronic dietary exposure is estimated at 0.00 3241 mg/kg/day for the general U.S. population ( 6.5 % of the cPAD) and 0.00 8326 mg/kg/day ( 1 7 % of the cPAD) for All Infants <1 year of age , the population subgroup with the highest estimated chronic dietary exposure.

X. List of Attachments

Attachment 1. Acute/Chronic Residue Input File for Dimethenamid / Dimethenamid

- P Attachment 2

. S ummary of the Acute Dietary Exposure and Risk Estimates. Attachment 3

. Summary of the Chronic Dietary Exposure and Risk Estimates.Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 10 of 13 Attachment 1. Acute/Chronic Residue Input File for Dimethenamid / Dimethenamid

- P

.

Filename: Dimethenamid 129051 and 120051.R08

Dimethenamid 129051 and 120051 Females 13 to 49.r08 Dimethenamid 129051 and 120051.R08 Chemical: Dimethenamid and Dimethenamid

- P RfD(Chronic): .05 mg/kg bw/day NOEL(Chronic): 5 mg/kg bw/day RfD(Acute All Populations except Females 13

- 49 ) : 2 mg/kg bw/day NOEL(Acute): 200 mg/kg bw/day RfD(Acute Females 13

- 49 ): 0.75 mg/kg bw/day NOEL(Acute): 75 mg/kg bw/day
Date creat ed/last modified: 08

- 28

- 2014/12:27:32 Program ver. 3.16, 03

- 08

- d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101050000 1AB Beet, garden, roots 0.010000 1.000 1.000 0101050001 1AB Beet, garden, roots

- b abyfood 0.010000 1.000 1.000 0101052000 1A Beet, sugar 0.010000 1.000 1.000 0101052001 1A Beet, sugar

- babyfood 0.010000 1.000 1.000 0101053000 1A Beet, sugar, molasses 0.010000 1.000 1.000 0101053001 1A Beet, sugar, molasses

- babyfood 0.010000 1.000 1.000 0101190000 1AB Horseradish 0.010000 1.000 1.000 0101314000 1AB Radish, roots 0.010000 1.000 1.000 0101327000 1AB Rutabaga 0.010000 1.000 1.000 0101388000 1AB Turnip, roots 0.010000 1.000 1.000 0103015000 1CD Arrowroot, flour 0.010000 1.000 1.000 0103015001 1CD Arrowroot, flour

- babyfood 0.010000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 0.010000 1.000 1.000 0103082000 1CD Cassava 0.010000 1.000 1.000 0103082001 1CD Cassava

- b abyfood 0.010000 1.000 1.000 0103139000 1CD Dasheen, corm 0.010000 1.000 1.000 0103166000 1CD Ginger 0.010000 1.000 1.000 0103166001 1CD Ginger

- babyfood 0.010000 1.000 1.000 0103167000 1CD Ginger, dried 0.010000 1.000 1.000 0103296000 1C Potato, chips 0.010000 1.000 1.000 0103297000 1C Potato, dry (granules/ flakes) 0.010000 6.500 1.000 0103297001 1C Potato, dry (granules/ flakes)

- b 0.010000 6.500 1.000 0103298000 1C Potato, flour 0.010000 6.500 1.000 0103298001 1C Potato, flour

- babyfood 0.010000 6.500 1.000 0103299000 1C Potato, tuber, w/peel 0.010000 1.000 1.000 0103299001 1C Potato, tuber, w/peel

- babyfood 0.010000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.010000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.010000 1.000 1.000 0103366000 1CD Sweet potato 0.010000 1.000 1.000 0103366001 1CD Sweet potato

- babyfood 0.010000 1.000 1.000 0103371000 1CD Tanier, corm 0.010000 1.000 1.00 0 0103387000 1CD Turmeric 0.010000 1.000 1.000 0103406000 1CD Yam, true 0.010000 1.000 1.000 0103407000 1CD Yam bean 0.010000 1.000 1.000 0200051000 2 Beet, garden, tops 0.010000 1.000 1.000 0200140000 2 Dasheen, leaves 0.010000 1.000 1.000 0200315000 2 Radish, tops 0.010000 1.000 1.000 0301165000 3A Garlic, bulb 0.010000 1.000 1.000 0301165001 3A Garlic, bulb

- babyfood 0.010000 1.000 1.000 0301237000 3A Onion, bulb 0.010000 1.000 1.000 0301237001 3A Onion, bulb

- babyfood 0.010000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.010000 9.000 1.000 0301238001 3A Onion, bulb, dried

- babyfood 0.010000 9.000 1.000 0301338000 3A Shallot, bulb 0.010000 1.000 1.000 0302198000 3B Leek 0.010000 1.000 1.000 0302239000 3B Onion, green 0.010000 1.000 1.000 0302338500 3B Shallot, fresh leaves 0.010000 1.000 1.000 0502063000 5B Broccoli raab 0.100000 1.000 1.000 0502389000 5B Turnip, greens 0.100000 1.000 1.000 0600347000 6 Soybean, seed 0.010000 1.000 1.000 0600349000 6 Soybean, soy milk 0.010000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.010000 1.000 1.000 0600350000 6 Soybean, oil 0.010000 1.000 1.000 0600350001 6 Soybean , oil

- babyfood 0.010000 1.000 1.000 0603030000 6C Bean, black, seed 0.010000 1.000 1.000 0603032000 6C Bean, broad, seed 0.010000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.010000 1.000 1.000Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 11 of 13 0603035000 6C Bean, great northern, seed 0.010000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.010000 1.000 1.000 0603038000 6C Bean, lima, seed 0.010000 1.000 1.00 0 0603039000 6C Bean, mung, seed 0.010000 1.000 1.000 0603040000 6C Bean, navy, seed 0.010000 1.000 1.000 0603041000 6C Bean, pink, seed 0.010000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.010000 1.000 1.000 0603098000 6C Chickpea, seed 0.010000 1.000 1.000 0603098001 6C Chickpea, seed

- babyfood 0.010000 1.000 1.000 0603099000 6C Chickpea, flour 0.010000 1.000 1.000 0603182000 6C Guar, seed 0.010000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.010000 1.000 1.000 0603203000 6C Lentil, seed 0.010000 1.000 1.000 0603348000 6C Soybean, flour 0.010000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.010000 1.000 1.000 0902308000 9B Pumpkin 0.010000 1.000 1.000 0902309000 9B Pumpkin, seed 0.010000 1.000 1.000 0902357000 9B Squash, winter 0.010000 1.000 1.000 0902357001 9B Squash, winter

- babyfood 0.010000 1.000 1.000 1500120000 15 Corn, field, flour 0.010000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.010000 1.000 1.000 1500121000 15 Corn, field, meal 0.010000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.010000 1.000 1.000 1500122000 15 Corn, field, bran 0.010000 1.000 1.000 1500123000 15 Corn, field, starch 0.010000 1.000 1.000 1500123001 15 Corn, f ield, starch

- babyfood 0.010000 1.000 1.000 1500124000 15 Corn, field, syrup 0.010000 1.000 1.000 * 1500124001 15 Corn, field, syrup

- babyfood 0.010000 1.000 1.000 * 1500125000 15 Corn, field, oil 0.010000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.010000 1.000 1.000 1500126000 15 Corn, pop 0.010000 1.000 1.000 1500127000 15 Corn, sweet 0.010000 1.000 1. 000 1500127001 15 Corn, sweet

- babyfood 0.010000 1.000 1.000 1500344000 15 Sorghum, grain 0.010000 1.000 1.000 1500345000 15 Sorghum, syrup 0.010000 1.000 1.000 2003128000 20C Cot tonseed, oil 0.010000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.010000 1.000 1.000 8601000000 86A Water, direct, all sources 0.153000 1.000 1.000 ** 8602000000 86B Water, indirect, all sourc es 0.153000 1.000 1.000 ** 9500188000 O Hop 0.050000 1.000 1.000 9500263000 O Peanut 0.010000 1.000 1.000 9500264000 O Peanut, butter 0.010000 1.890 1.000 9500265000 O Peanut, oil 0.010000 1.000 1.000 Filename:

* In accordance with DESAC determination, DEEM default processing factor (1.5) is not needed

.

** Because the maximum EDWC for acute (groundwater 15 3 μg/L) and chronic (groundwater 1 40 μg/L) are so close, 15 3 μg/L was used to estimate residues in drinking water for both the acute and chronic assessments.Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 12 of 13 Attachment 2. Summary of Acute Dietary Exposure and Risk Estimates for Dimethenamid/Dimethenamid

- P

.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for DIMETHENAMID AND DIMETHENAMID

- P NHANES 2003

- 2008 2

- Day Residue file: Dimethenamid 129051 and 120051.R08 Adjustment factor #2 NOT used. Analysis Date: 08

- 28

- 2014/12:31:12 Residue file dated: 08

- 28

- 2014/12:27:32 RfD(Acute All Popu lations except Females 13

- 49 ) : 2 mg/kg bw/day NOEL(Acute): 200 mg/kg bw/day RAC/FF intake summed over 24 hours Run Comment: ""

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

Summary calculations

-- per capita:

--- 95th P ercentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Populati on: 0.008399 0.42 23812 0.013815 0.69 14476 0.026261 1.31 7615 All Infants: 0.026253 1.31 7618 0.035458 1.77 5640 0.051967 2.60 3848 Children 1

- 2: 0.013042 0.65 15335 0.019557 0.98 10226 0.047591 2.38 4202 Children 3

- 5: 0.010635 0.53 18806 0.016197 0.81 12347 0.025825 1.29 7744 Children 6

- 12: 0.008023 0.40 24926 0.013146 0.66 15214 0.020261 1.01 9870 Youth 13

- 19: 0.006982 0.35 28646 0.011490 0.57 17405 0.017318 0.87 11548 Adults 20

- 49: 0.008253 0.41 24234 0.012219 0.61 16367 0.017839 0.89 11211 Adults 50

- 99: 0.007364 0.37 27159 0.011121 0.56 17983 0.017559 0.88 11390

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for DIMETHENAMID AND DIMETHENAMID

- P NHANES 2003

- 2008 2

- Day Residue file: Dimethenamid 129051 and 120051 Females 13 to 49.r08 Adjustment factor #2 NOT used. Analysis Date: 08

- 28

- 2014/12:32:24 Residue file dated: 08

- 28

- 2014/12:28:06 RfD(Acute Females 13

- 49 ): 0.75 mg/kg bw/day NOEL(Acute): 75 mg/kg bw/day RAC/FF intake summed over 24 hours Run Comment: ""

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Female 13

- 49: 0.008361 1.11 8970 0.012255 1.63 6119 0.017317 2.31 4330Dimethenamid/Dimethenamid

- P Dietary Exposure and Risk Assessment DP Number: 418116



### Page 13 of 13 Attachment 3. Summary of Chronic Dietary Exposure and Risk Estimates for DImethenamid/Dimethenamid

- P

.

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for DIMETHENAMID AND DIMETHENAMID

- P NHANES 2003

- 2008 2

- day Residue file name: D imethenamid 129051 and 120051.R08 Adjustment factor #2 NOT used. Analysis Date 08

- 28

- 2014/ 12:34:40 Residue file dated: 08

- 28

- 2014/12:27:32 RfD(Chronic): .05 mg/kg bw/day NOEL(Chronic): 5 mg/kg bw/day

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

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

Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.003241 6.5% Hispanic 0.003101 6.2%
Non

- Hisp

- White 0.003331 6.7%
Non

- Hisp

- Black 0.002683 5.4%
Non

- Hisp

- Other 0.003732 7.5% Nursing Infants 0.002930 5.9%
Non

- Nursing Infants 0.010736 21.5% Female 13+ PREG 0.003050 6.1% Children 1

- 6 0.004189 8.4% Children 7

- 12 0.002728 5.5% Male 13

- 19 0.002243 4.5% Female 13

- 19 /NP 0.002501 5.0% Male 20+ 0.003017 6.0% Female 20+/NP 0.003392 6.8% Seniors 55+ 0. 003123 6.2% All Infants 0.008326 16.7% Female 13

- 50 0.003218 6.4% Children 1

- 2 0.004710 9.4% Childr en 3

- 5 0.003980 8.0% Children 6

- 12 0.002868 5.7% Youth 13

- 19 0.002373 4.7% Adults 20

- 49 0.003228 6.5% Adults 50

- 99 0.003186 6.4% Female 13

- 49 0.003214 6.4%

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