UNITED STATES ENVIRONMENT AL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 3/16/2016 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Aminocyclopyrachlor: Acute and Chronic Dietary Exposure Analysis for the 

Tolerance Petition in Milk and Livestock Commodities. 

PC Code: 288008, 288009 

Decision No.: 443551 

Petition No.: OF78 I 7 

Risk Assessment Type: Single Chem/No Agg. 

TXR No.: None 

MRID No.: None 

FROM: Thurston G. Morton, Chemist 

DP Number: 0432084 

Registration No.: None 

Regulatory Action: Tolerance without U.S. 

registration 

Case No.: None 

CAS No.: 858956-08-8, 858954-83-3 

40 CFR: None (First Food Use) 

Risk Assessment Branch JV (RABIV) 

THROUGH: 

TO: 

Health Effects Division (HED; 7509P) , ~ ~ 

Dennis McNeilly, Chemist (RAB IV) tPr· /:11 zrt,, - P. Yvonne Barnes, Chemist (RAB Vl) lf>/l{)~-t~ f~ Dietary Exposure Science Advisory Council (DE SAC) 

HED (7509P) 

and 

Elissa Reaves, PhD, Branch Chief 

RAB IV 

HED (7509P) 

Reuben Baris/Mindy Ondish 

Herbicide Branch/RD (7505P) 

Page I of 16 

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Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: 0432084 

Executive Summary 

Aminocyclopyrachlor is an herbicide active ingredient (a.i.) currently registered for non-food 

use. The registrant, E. I. du Pont de Nemours and Company, previously requested a Section 3 

registration for the first food uses on rangeland and pastures. However, that request was 

withdrawn and the registrant is proposing to establish import tolerances in milk and livestock 

commodities. Therefore, this memorandum serves to update the previous assessment (T. Morton, 

D387446, 04/18/20 12) by assessing exposure and risk from livestock tissues and milk from 

imported sources only. f n addition, the registered uses on lawn and turf which resulted in 

residential exposure have been removed. 

An acute and chronic dietary exposure analysis (food and drinking water) was performed in 

order to support a request for the proposed new import tolerances of aminocyclopyrachlor in 

milk and livestock commodities. The analysis was performed 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). 

A new drinking water assessment was conducted and incorporated into this dietary exposure 

analysis. Since the action requested is for the establishment of import-only tolerances only, no 

new occupational/residential exposure assessment were conducted. Therefore, this 

memorandum will serve as an addendum to the previous risk assessment conducted by HED and 

to serve as an update to the dietary exposure and tolerance recommendations. Please refer to the 

previous risk assessment (J. Ryman, 0387448, 04/ 18/2012) 

This memorandum was reviewed by two peer reviewers of the DESAC per DESAC SOP 2012.1. 

Acute Dietary Exposure Results and Characterization 

An acute dietary endpoint was not identified for the parent aminocyclopyrachlor but one was 

identified for the water degradate cyclopropane carboxylic acid (fN-V0977). In the acute dietary 

exposure analysis for fN-V0977, the most highly exposed population subgroup is All Infants ( <l 

year old) with an estimated risk of 11 % of the aPAD. The general U.S. population has an 

estimated risk of3.6% of the aPAD. 

Chronic Dietary (Drinking Water Onlv) Exposure Results and Characterization 

The conservative chronic dietary exposure analysis is based on tolerance level residues in food 

and drinking water for parent and drinking water only for the water metabolite IN-V0977. In the 

conservative chronic dietary exposure analysis for aminocyclopyrachlor, the most highly 

exposed population subgroup is All Infants ( <1 year old) which utilizes < l % of the cPAD. The 

general U.S. population utilizes < l % of the cPAD for the parent. In the chronic dietary exposure 

analysis, the most highly exposed population subgroup is All Infants (< l year old) which has an 

estimated risk of 7.4% of the cPAD. The general U.S. population has an estimated risk of2.9% 

of the cPAD. 

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Aminocyclopyrach for Dietary Exposure and Risk Assessment DP Number: 0432084 

Cancer Dietary Exposure Results and Characterization 

No cancer endpoint has been identified, therefore no cancer dietary assessment is necessary. 

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 hea lth effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors. 

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 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 from Pesticides, A User's Guide," 21 -JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Dav- 12/6061.pdf; or see SOP 99.6 (20-AUG1999). 

The most recent dietary risk assessment for aminocyclopyrachlor was conducted by T. Morton 

(04/ 18/20 12, D387446). 

II. Residue Information 

Aminocyclopyrachlor is a relatively new a.i. and previously was not registered for any food or 

feed uses. The Residue of Concern Knowledge base Subcommittee (ROCKS), concluded that the 

residues of concern for livestock commodities are aminocyclopyrachlor and 

aminocyclopyrachlor methyl ester (D3936 l 9, I. Negron-Encarnacion, 09/22/2011 ). Tolerances 

levels were used for livestock commodities. The ROCKS, also concluded that the residues of 

concern for drinking water are parent and IN-Y0977 (0370638, G. Kramer, 10/ 15/2009). The 

rationale is as follows. Based on (geductive ~s timate of risk from ~xisti g _knowledge) 

(DEREKTM) alerts and toxicology studies in the open scientific literature, degradate IN-Y0977 

( cyclopropane carboxylic acid) appears to have a different mode of toxicity than the parent 

compound. Hepatic steatosis was observed when male SD rats were administered cyclopropane 

carboxylic acid at 500 mg/kg/day (i.p.) for I or 3 days (Jolly et al. 2004). This indicates that 1NY0977 may be more toxic than the parent compound, aminocyclopyrachlor, since no evidence of 

hepatic steatosis was observed in toxicity database for the parent. ROCKS thus recommends the 

petitioner provide toxicology studies so that HED can determine the appropriate endpoints for 

IN-Y0977 or provide an acceptable rationale for exclusion of IN-Y0977 as a residue of concern 

in drinking water. 

Page 3of16 
Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: D432084 

Table I. Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance 

Expression. 

Matrix Residues included in Risk Assessment Residues included in Tolerance 

Expression 

Plants Primary Crop Aminocyclopyrachlor and Aminocyclopyrachlor and 

(grasses only) Aminocyclopyrachlor methyl ester1 Aminocyclopyrachlor methyl ester 

Rotational Crop Aminocyclopyrachlor and Aminocyclopyrachlor and 

Aminocyclopyrachlor methyl ester Aminocyclopyrachlor methyl ester 

Livestock Ruminant Aminocyclopyrachlor and Aminocyclopyrachlor and 

Aminocyclopyrachlor methyl ester Aminocyclopyrachlor methyl ester 

Poultry Not Applicable Not Applicable 

Drinking Water Aminocyclopyrachlor, IN-V0977 Not Applicable 1 Aminocyclopyrachlor is 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylic acid; Aminocyclopyrachlor 

methyl ester is methyl 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylate. 

Tolerances from memorandum T. Morton, 387442, 4/18/ 12. However, meat and milk tolerances 

have been reduced to 0.01 ppm to harmonize with PMRA along with fat to 0.05 ppm. 

Table 2. Recommended Tolerances fo r Aminocvcloovrachlor. 

Commodity DuPont HED PMRA 

Proposed Recommendation Established 

Fat (Cattle, Horse, Goat, 0.07 0.05 0.05 

Sheep) 

Meat (Cattle, Horse, Goat, 0.02 0.01 0.01 

Sheeo) 

Meat byproducts (Cattle, -- 0.3 0.3 

Horse, Goat, Sheep) 

Meat byproducts, except liver 0.4 -- -- (Cattle, Horse, Goat, Sheep) 

Liver (Cattle. Horse. Goat, 0.06 -- -- Sheeo) 

Milk 0.035 0.01 0.01 

III. Percent Crop Treated Information 

100% CT was assumed for all commodities. 

IV. Drinking Water Data 

The Estimated Drinking Water Concentrations (EDWCs) used in the acute and chronic dietary 

risk assessment was provided by the Environmental Fate and Effects Division (EFED) (Memo, 

0432215, W. Eckel, 3/14/2016). The annual average EDWC for chronic exposure assessment 

was incorporated directly into the dietary assessment in the food categories "water, direct, all 

sources'· and "water, indirect, all sources:· A revised drinking water assessment (OW A) for 

aminocyclopyrachlor acid (ACP) and its degradate IN-Y0977 was completed on January 8, 2010 

(DP 368238). This memorandum updates the previous DW A by reviewing the Tier I surface 

water analysis (FIRST model) and by updating the ground water analysis using the PRZM-GW 

model. 

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Aminocyclopyrachlor Dietary Exposure and Risk Assessment OP Number: 0432084 

Surface Water. The previous FIRST surface water modeling was found to be appropriately 

conservative by testing in the Tier TI model SWCC, including both the experimental Tier I 

scenario and the PA turf scenario. The acute and chronic estimated drinking water 

concentrations (EDWCs) for surface water were reported in the 20 10 DWA to be 25.6 and 15.9 

ug/L (ppb), respectively for a single ground or aerial application at 0.284 lb/A. However, a 

percent cropped area (PCA) of 0.87 was appli ed to these results, which is not appropriate for this 

use pattern. The corrected results, with a PCA value of 1.0, are 29.4 ppb (acute) and 18.3 

ppb (chronic). The results for the degradate fN-V0977 are l.7 ppb (acute) and 1.2 ppb (chronic) 

after correcting the PCA factor. These results apply to both aerial and ground application. Pease 

refer to the 2010 DWA for details of the environmental fate profile and properties of ACP. 

Ground Water. For ground water, the six PRZM-GW scenarios were rw1, and the highest result 

was for the NC Coastal scenario. The acute EDWC is 116 ug/L (ppb), and the chronic EDWC is 

78 ppb. 

Recommended EDWCs. EFED therefore recommends the following EDWCs for the non-crop 

areas use. 

Surface water (parent), acute: 29.4 ppb; chronic, 18.3 ppb. 

Surface water (IN-V0977), acute, 1. 7 ppb; chronic 1.2 ppb. 

Ground water, acute (parent only): 116 ppb; chronic 78 ppb. 

Additional information concerning the water models is available at the EPA internet site: 

http://www. cpa. gov I oppef ed/models/water/. 

V. DEEM-FCID Program and Consumption Information 

The aminocyclopyrachlor acute and chronic dietary exposure assessment was 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 two non-consecutive survey days. Foods "as consumed" (e.g., apple pie) are 

linked to EPA-defined food commodities (e.g .. apples, peeled fruit - cooked; fresh or N/S; baked; 

or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files 

developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data 

are averaged for the entire U.S. population and within population subgroups. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns 

and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general U.S. population, all infants (<1 year old), children 

1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 

years old. 

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodforrn (e.g .. orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

Page 5of16 
Ami nocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: 0432084 

The resulting residue intake estimate for each food/food form is sununed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup. 

For 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 sununed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or "matched" in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e .. only those who reported eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for analyses performed at all levels of refinement. However, for 

deterministic assessments. any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment. 

VI. Toxicological Information 

The toxicological doses and endpoints for aminocyclopyrachlor and its degradate fN-V0977 for 

use in the dietary assessment are summarized in Tables 4 and 5, respectively. 

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Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: D432084 

Table 4. Summary of Toxicological Doses and Endpoints for Aminocyclopyrachlor for Use in Human 

Health Risk Assessments. 

RID, PAD, 

Exposure/ Point of Uncertainty/FQP Level of 

Scenario Departure A Safety Factors Concern for Study and Toxicological Effects 

Risk 

Assessment 

Acute Dietary 

(General 

Population, NA Acute Neurotoxicity-rat (870.6200a) 

including (No hazard NOA EL = 2000 mg/kg/day. No acute 

Females 13- NA NA neurotox icity. 

49 years of was 

age and identified). 

Infants and 

Children) 

Chronic RID Combined chronic 

Chronic NOA EL= UF"= IOx =2.79 toxicity/carcinogenicity-rat 

Dietary (All 279 UF11= IOx mg/kg/day 

Populations) mg/kg/day FQPA SF= Ix LOA EL = 892/957 mg/kg/day based on 

cPAD = 2.79 mild decreases in body weight/body 

mg/kg/day weie.ht gain 

Cancer (oral, 

dennal, .. Not likely" to be carcinogenic in humans (J. Kidwell, TXR 0056120, 11 /9/11) 

inhalation) 

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 detern1ine risk associated with lower environmentally relevant human 

exposures. NOA EL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncenainty factor. UF" = extrapolation from animal 10 human (interspecies). UF11 = potential variation in 

sensitivity among members of the human population (imraspecics). FQPA SF = FQPA Safety Factor. PAD = 

population adjusted dose (a = acute, c = chronic). RID = reference dose. NIA = not applicable. 

Page 7of16 
Am inocyclopyrach lor Dietary Exposure and Risk Assessment DP Number: D432084 

Table 5. Summa ry of Toxicological Doses and Endpoints for IN-V0977 (cyclopropane ca rboxylic acid) 

de2radate for Use in Human Health Risk Assessments 

RID, PAD, Level of 

Exposure/ Point of Uncertainty Concern for Risk 

Scena rio Departure Factors Assessment Study and Toxicological Effects 

UFA= IOx Rabbit study 

LOAEL = UF11 = I Ox RID= 47916803( 1998) 

Acute Dietary 2.55 UFLN= IOx 0.0026 mg/kg/day Non-guideline, oral (gavage) for 2 1 days 

(All Populations) mg/kg/day Child- aRfD= 0, I 0. 20 mg/kg/day (panadiplon) 

LOAEL = I 0 mg/kg/day based on hepatic CPCA protective SF 0.0026 mg/kg/day steatosis = I 

UFA= IOx RID= Rabbit study 

LOAEL = UF1t = !Ox 0.00087 47916803 (1998) 

Chronic Dietary 2.55 UFLN= IOx mg/kg/day Non-guideline, oral (gavage) for 2 1 days 

mg/kg/day UFsc= 3x cRfD= 0, I 0, 20 mg/kg/day (panadiplon) (All population) CPCA Child- 0.00087 LOAEL = 10 mg/kg/day based on hepatic 

protective SF mg/kg/day steatosis 

= \ 

Cancer (oral, 

derma l, NIA 

inhalation) 

Point of Depanure (PoD) = A data point or an estimated point that is derived from observed dos~response data and used to mark the beginning 

of extrapolation 10 dc1cm1ine risk associated with lower environmentally relevant human exposures. NOA EL= no observed adverse cfCct level. 

LOA EL = lowest observed adverse effect level. SF= safety factor. UF = mccrtainty factor. UF,. = cxtrapolalion from animal 10 human 

(interspecies). UFH = potential variation in scnsi1i1•ity among mcnt>ers of the human population (intraspccics). UFLN • database uncertainty for 

extrapolation of LOA EL 10 NOAEL. UFsc • database uncertainty for extrapolation of subcrhoni c 10 chronic. RID = reference dose. NIA = not 

available. No cancer study availoolc at this time. 

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analysis estimates the dietary exposure of the U.S. 

population and various population subgroups. Table 3 lists the results of the chronic dietary 

exposure analysis 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, ad ults 20-49, and adults 50-99 years for the 

parent aminocyclopyrachlor. 

In the conservative chronic di etary exposure analysis for arninocyclopyrachlor, the most highly 

exposed population subgroup is All Infan ts (<l year old) which utili zes < l % of the cPAD. The 

general U.S. population utilizes <1 % of the cPAD. 

Page 8of1 6 
Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: D432084 

Table 3. Summary of Dietary Exposure and Risk for Aminocyclopyrachlor Parent (Food and 

Drinking Water) 

Acute Dietary Chronic Dietary Cancer 

Dietary Dietary Dietary 

Exposure Exposure Exposure 

Population Subgroup* (mg/kg/day) %aPAD (mg/kg/day) %cPAD (mg/kg/day) Risk 

General U.S. Population 0.001717 <I 

Not applicable: No acute Not Applicable at this 

All Infants(< I year old) dietary endpoint was 0.004336 <I time. 

Children 1-2 years old identified 0.002827 <I 

Children 3-5 years old 0.002259 <I 

Children 6-12 years old 0.001587 <I 

Youth 13-19 years old 0.001263 <I 

Adults 20-49 years old 0.001680 <I 

Adults 50+ years old 0.001657 <I 

Females 13-49 years old 0.00 1673 <I 

*The values for the highest exposed population for each type of risk assessment are bolded. 

Table 4 lists the results of the acute and chronic dietary exposure analyses for the general U.S. 

Population, all infants ( < 1 year old), children 1-2, children 3-5. children 6-1 2, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years for the degradate of aminocyclopyrachlor 

TN-Y0977. 

Jn the acute dietary exposure analysis for TN-Y0977, the most nighJy exposed population 

subgroup is All Infants (<l year old) with an estimated risk of 11 % of the aPAD. The general 

U.S. population has an estimated risk of 3.6% of the aPAD. 

In the chronic dietary exposure analysis, the most highly exposed population subgroup is All 

Infants (< I year old) which has an estimated risk of 7.4% of the cPAD. The general U.S. 

population has an estimated risk of2.9% of the cPAD. 

Page 9of 16 
Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: D432084 

Table 4. Summary of Dietary Exposure and Risk for Aminocyclopyrachlor Degradate (INV0977) (Drinking Water Only) 

Acute Dietary 

Chronic Dietary Cancer 95ih percentile 

Dietary Dietary Dietary 

Exposure Exposure Exposure 

Population Subgroup* (mg/kg/day) % aPAD (mg/kg/day) % cP A D (mg/kg/day) Risk 

General U.S. Population 0.000093 3.6 0.000025 2.9 

Not applicable at this 

All In fants(< I year old) 0.000290 I I 0.000065 7.4 time. 

Children 1-2 years old 0.000 143 5.5 0.000036 4.2 

Children 3-5 years old 0.000116 4.5 0.000031 3.5 

Children 6- 12 years old 0.000089 3.4 0.000022 2.5 

Youth 13- 19 years old 0.000077 3.0 0.0000 18 2. 1 

Adults 20-49 years old 0.000091 3.5 0.000025 2.9 

Adults 50+ years old 0.000081 3. 1 0.000025 2.8 

Females 13-49 years old 0.000093 3.6 0.000025 2.9 

* The va lues for the hig hest exposed population for each type of risk assessment are bolded. 

VIII. Characterization of Inputs/Outputs 

In the acute and chronic dietary exposure analyses, conservati ve EDWCs were used for both the 

parent aminocyclopyrachlor and the degradate IN -V0977. The general U.S. population and all 

regulated population subgroups have risk estimates that are below HED's level of concern. 

Therefore, residue refinements are not required at this time. Tolerance level residues in livestock 

commodities along with 100% crop treated were used in the conservative chronic dietary 

exposure assessment for aminocyclopyrachlor parent. As previously stated, use if an import onl y 

use, therefore, using 100% crop treated will not result in an underestimation of risk. 

IX. Conclusions 

Based on a relatively conservative estimate of aminocyclopyrachlor and IN-V0977 

concentrations in drinking water, the acute and chronic dietary risk estimates for the general U.S. 

population and all regul ated population subgroups are below HED's level of concern. Tolerance 

level residues of aminocyclopyrachlor in livestock commodities were used in the chronic dietary 

exposure assessment for parent and resulted in chronic dietary risk estimates for the general U.S. 

population and all regulated population subgroups below HED's level of concern. Given the 

conservati ve nature of the inputs, these assessments are unlikely to underestimate risks to 

aminocyclopyrachlor and IN-V0977. 

Page 10ofl 6 
Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: D432084 

X. List of Attachments 

Attachment I: Residue Input File for Acute Dietary Exposure Analysis 

Attachment 2: Residue Input File for Chronic Dietary Exposure Analysis 

Attachment 3: Results of Acute Dietary Exposure Analysis 

Attachment 4: Results of Chronic Dietary Exposure Analysis 

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Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP umber: 0 432084 

Attachment 1: Residue Input File for Acute Dietary Exposure Analysis 

IN-V0977 Onl y 

Filename : C: \Users\tmorton\Documents\My Files\DEEM Files\288008 Aminocyclopyrachlor\Import 

Pasture and Grass uses So Imported Livestock MMPE only\288008 Acute Water Only IN-V0977 .R08 

Chemical : Arninocyclopyrachlor Me t abolite IN-V0977 

Rf D(Chronic) : . 00087 mg/kg bw/day NOEL(Chronic) : 0 mg/kg bw/day 

Rf D(Acute) : . 0026 mg/kg bw/day NOEL(Acute) : 0 mg/kg bw/day 

Date created/last modified : 03-15-2016/08 : 30 : 20 Program ver . 3 . 16, 03-08-d 

EPA 

Code 

Crop 

Grp Commodity Name 

8601000000 86A Water, direct, all sources 8602000000 86B water, indirect, all sources 

Def Res 

(ppm) 

0 . 001700 

0 . 001700 

Adj . Factors Comment 

li1 82 

1.000 1.000 

1 . 000 1 . 000 

Attachment 2: Residue Input File for Chronic Dietary Exposure Analysis 

Parent Only 

Filename : C: \Users\tmorton\Documents\My Files\DEEM Files\288008 Aminocyclopyrachlor\Import 

Pasture and Grass Uses So Imported Livestock MMPE onl y\288008 Chronic Food and Water Parent 

Only . ROS 

Chemical : Arninocyclopyrachlor 

RfD(Chronic) : 2 . 79 mg/kg bw/day NOEL(Chronic) : 350 mg/kg bw/day 

RfD(Acute) : 0 mg/kg bw/day NOEL (Acute) : 0 mg/kg bw/day 

Date created/last modified : 03-15- 2016/08 : 31 : 23 Program ver . 3 . 16, 03-08-d 

EPA Crop 

Code Grp Commodity Name 

Def Res 

(ppm) 

3100044000 31 

3100044001 31 

3100045000 31 

3100046000 31 

3100046001 31 

3100047000 31 

3100047001 31 

3100048000 31 

3100049000 31 

3100049001 31 

3200169000 32 

3200170000 32 

3200171000 32 

3200172000 32 

3200173000 32 

3300189000 33 

3500339000 35 

3500339001 35 

3500340000 35 

3500341000 35 

3500341001 35 

3500342000 35 

3500343000 35 

3600222000 36 

3600222001 36 

3600223000 36 

3600223001 36 

3600224000 36 

3600224001 36 

3600225001 36 

8601000000 86A 

8602000000 86B 

Beef, meat 

Beef, meat-babyfood 

Beef, meat, dried 

Beef, meat byproducts 

Beef, meat byproducts- babyfood 

Beef, fat 

Beef, fat-babyfood 

Beef, kidney 

Beef, liver 

Beef, liver-babyfood 

Goat, meat 

Goat, meat byproducts 

Goat , fat 

Goat, kidney 

Goat, liver 

Horse , meat 

Sheep, meat 

Sheep , meat-babyfood 

Sheep, meat byproducts 

Sheep, fat 

Sheep, fat-babyfood 

Sheep, kidney 

Sheep, liver 

Milk , fat 

Milk, fat-baby food/infant formu 

Milk, nonfat solids 

Milk, nonfat solids-baby food/in 

Milk , water 

Milk, water-babyfood/infa nt form 

Milk, sugar (lactose) - baby food/ 

Water, direct, all sources 

Water, indirect, all sources 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 300000 

0 . 300000 

0 . 050000 

0 . 050000 

0 . 300000 

0 . 300000 

0 . 300000 

0 . 010000 

0 . 300000 

0 . 050000 

0 . 300000 

0 . 300000 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 300000 

0 . 050000 

0 . 050000 

0 . 300000 

0 . 300000 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 010000 

0 . 078000 

0 . 078000 

Page 12 of16 

AdJ . Factors Comment 

H #2 

1 . 000 

1 . 000 

1 . 920 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 
Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: 0432084 

IN-V0977 Only 

Filename : C: \Users\tmorton\Documents\My files\DEEM flles\288008 Aminocyclopyrachlor\Import 

Pasture and Grass Uses So Imported Livestock MMPE only\288008 Chronic Water Only IN-V0977 .R08 

Chemical : Aminocyclopyrachlor Metabolite IN-V0977 

RfD(Chronic) : . 00087 mg/kg bw/day NOEL(Ch ronic) : O mg/kg bw/day 

RfD(Acute) : . 0026 mg/l:g bw/day NOEL (Acute) : 0 mg/kg bw/day 

Date created/last modified : 03-15-2016/08 : 32 : 29 Program ver . 3 . 16, 03 - 08-d 

EPA Crop Def Res AdJ . Factors Comment 

Code Grp Commodity Name (ppm) #1 #2 

---------- ------------------------------- ---------- ------- 8601000000 86A Water, direct, all sources 0 . 001200 l . 000 1 . 000 

8602000000 868 Water, indirect, all sources 0 . 001200 1 . 000 1 . 000 

Page 13of16 
Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: D432084 

Attachment 3: Results of Acute Dietary Exposure Analysis 

fN-V0977 Only 

US EPA Ver . 3 . 18, 03-08-d 

DEEM-FCID ACUTE Analysis for AMINOCYCLOPYRACHLOR METABOLITE IN- V0977 

NHANES 2003-2008 2-Day 

Residue file : 288008 Acute Water Only IN-V0977 .R08 

Adjustment factor H2 NOT used . 

Analysis Date : 03-15-2016/15 : 18 : 37 Residue f ile dated : 03 - 15-2016/15 : 15 : 24 

RAC/FF intake summed over 24 hours 

Run Comment : "" 

Summary calculations--per capita : 

95th Percentile 99th Percentile 99 . 9th Percentile 

Exposure % aRfD Exposure ~ aRfD Exposure % aRfD 

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

Total us Population : 

0 . 000093 3 . 57 0 . 000153 5 . 88 0 . 000290 11.17 

All Infants : 

0 . 000290 11 . 17 0 . 000393 15 . 13 0 . 000576 22 . 17 

Children 1- 2 : 

0 . 000143 5 . 50 0 . 000215 8 . 28 0 . 000530 20 . 39 

Children 3- 5 : 

0 . 000116 4 . 46 0 . 000178 6 . 83 0 . 000285 10 . 97 

Children 6- 12 : 

0 . 000089 3 . 41 0 . 000145 5 . 59 0 . 000224 8 . 62 

Youth 13-19 : 

0 . 000077 2 . 97 0 . 000127 4 . 89 0 . 000192 7 . 38 

Adults 20-49 : 

0 . 000091 3 . 51 0 . 000136 5 . 22 0 . 000197 7 . 60 

Adults 50- 99 : 

0 . 000081 3 . 13 0 . 000123 4 . 74 0 . 000194 7 . 47 

Female 13-49 : 

0 . 000093 3 . 56 0 . 000136 5 . 23 0 . 000191 7 . 34 

Page 14ofl6 
Arn inocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: 0432084 

Attachment 4: Results of Chronic Dietary Exposure Analysis 

Parent Only 

us EPA Ver . 3 . 16, 03-08-d 

DEEM-FCID Chronic analysis for AMINOCYCLOPYRACHLOR NHANES 2003 - 2008 2- day 

Residue file name : C: \Users\tmorton\Documents\My Files\DEEM Files\288008 

Aminocyclopyrachlor\Import Pasture and Grass Uses So Imported Livestock ~~lPE only\288008 Chronic 

Food and Water Parent Only . ROS 

Adjustment factor #2 NOT used . 

Analysis Date 03-15-2016/15 : 17 : 14 Residue file dated: 03- 15- 2016/15 : 14 : 32 

Reference dose (RfD, Chronic) = 2 . 79 mg/kg bw/day 

Population 

Subgroup 

Total US Population 

Hispanic 

Non- Hisp-White 

Non - Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Chil dren 1-6 

Children 7-12 

Male 13- 19 

Female 13- 19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13- 50 

Children 1- 2 

Children 3- 5 

Children 6- 12 

Youth 13-19 

Adults 20-49 

Adults 50 - 99 

Female 13- 49 

Total exposure by population subgroup 

Total Exposure 

mg/kg Percent of 

body wt/day Rfd 

------------- ---------------- 0 . 001717 0 . 1% 

0 . 001664 0 . 1% 

0 . 001761 0 . 1% 

0 . 001420 0 . 1% 

0 . 001968 0 . 1% 

0 . 001516 0 . 1% 

0 . 005595 0 . 2% 

0 . 001602 0 . 1% 

0 . 002426 0 . 1% 

0 . 001506 0 . 1% 

0 . 001206 0 . 0% 

0 . 001319 0 . 0% 

0 . 001574 0 . 1% 

0 . 001761 0 . 1% 

0 . 001626 0 . 1% 

0 . 004336 0 . 2% 

0 . 001675 0 . 1% 

0 . 002827 0 . 1% 

0 . 002259 0 . 1% 

0 . 001587 0 . 1% 

0 . 001263 0 . 0% 

0 . 001680 0 . 1% 

0 . 001657 0 . 1% 

0 . 001673 0 . 1% 

Page 15of16 
Am inocyclopyrach lor Dietary Exposure and Risk Assessment DP Number: D432084 

IN-V0977 Only 

us EPA Ver . 3 . 16, 03-08-d 

DEEM- FCID Chronic analysis for AMINOCYCLOPYRACHLOR METABOLITE IN- V0977 

NHANES 2003-2008 2-day 

Residue file name : C: \Users\tmorton\Documents\My Files\DEEM Files\288008 

Arninocyclopyrachlor\Import Pasture and Grass Uses So Imported Livestock MMPE only\288008 Chronic 

Water Only IN-V0977 . R08 

Adjustment factor #2 NOT used . 

Analysis Date 03 - 15- 2016/15 : 17 : 38 Residue file dated : 03-15- 2016/15 :16 : 20 

Reference dose (RfD, Chronic) = . 00087 mg/kg bw/day 

Total exposure by populati on subgroup 

Total Exposure 

Population 

Subgroup 

Total US Population 

Hispanic 

Non- Hisp-White 

Non- Hisp- Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1-6 

Children 7- 12 

Male 13- 19 

Female 13- 19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3-5 

Children 6- 12 

Youth 13- 19 

Adults 20- 49 

Adults 50- 99 

Female 13-49 

mg/kg Percent of 

body wt/day Rfd 

------------- ---------------- 0 . 000025 2 . 9% 

0 . 000024 2 . 8% 

0 . 000026 3 . 0% 

0 . 000021 2 . 4% 

0 . 000029 3 . 3% 

0 . 000023 2 . 6% 

0 . 000084 9 . 6% 

0 . 000024 2 . 7% 

0 . 000032 3 . 7% 

0 . 000021 2 . 4% 

0 . 000017 2 . 0% 

0 . 000019 2 . 2% 

0 . 000023 2 . 7% 

0 . 000026 3 . 0% 

0 . 000024 2 . 8% 

0 . 000065 7 . 4% 

0 . 000025 2 . 9% 

0 . 000036 4 . 2% 

0 . 000031 3 . 5% 

0 . 000022 2 . 5% 

0 . 000018 2 . 1% 

0 . 000025 2 . 9% 

0 . 000025 2 . 8% 

0 . 000025 2 . 9% 

Page 16of16