Acequinocyl Dietary Exposure and Risk Assessment

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### UNITED STA

**TES ENVIRONMENTA L PROTECTION A** **GENCY**

**MEMORANDUM Date:**  30 - NOV - 20 1 1 **SUBJECT: Acequinocyl.**  Chronic Aggregate Dietary (Food Risk Assessment for the Section 3 Registration Action Vegetable; Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13 07A; Melon Subgroup 9A; Cucumber 07 G; and Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13 **PC Code:** 006329 **Decision No.:** 4 48205 **Petition No.:** 1 E 7 8 64 **Risk Assessment Type:** Dietary **T XR No.:**  NA **MRID No.:** NA **FROM:** Sarah J. L ev y, Chemist

Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P) **THROUGH:** Doug Dotson , Ph.D.,

Amelia Acierto , Chemist Dietary Exposure Science Advisory Council (DESAC) and George F. Kramer, Ph.D. RAB1 /H ED (7509P) **TO:** Sarah J. L ev y, Chemist/Risk Assessor

RAB1/HED (7509P) and Barbara Madden, RM 05 Registration Division (

Dietary Exposure and Risk Assessment

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### UNITED STA

**TES ENVIRONMENTA L PROTECTION A** **GENCY**

**WA SHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION** 



### Chronic Aggregate Dietary (Food + Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action Use on Succulent Soy bean Vegetable; Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13 07A; Melon Subgroup 9A; Cucumber ; Cherry ; Low - Growing Berry Subgroup 13 G; and Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13 **DP Barcode:** D 389990 **Registration No. :**  66330 - 38 **Regulatory Action:** Section 3 Dietary **Case No.:**  7621

**CAS No.:** 57960 - 19 - 7 **40 CFR:** §180.599 Sarah J. L ev y, Chemist Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

Ph.D., Chemist Chemist Exposure Science Advisory Council (DESAC) /HED (7509P) George F. Kramer, Ph.D. , Branch Senior Scientist

(7509P) Sarah J. L ev y, Chemist/Risk Assessor

(7509P) Barbara Madden, RM 05

Division ( RD; 7 505 P) DP# 389990

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### UNITED STA

**TES ENVIRONMENTA L PROTECTION A** **GENCY OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION**



### Drinking Water) Exposure and

Succulent Soy

bean Vegetable; Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13 - Growing Berry

Subgroup 13 - G; and Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13 - 07F . Section 3

Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P) (7509P)Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### Exec **utive Summary** A chronic aggregate dietary (food + drinking water) exposure and risk assessment w as conducted using the Dietary

E xposure Evaluation Model ( DEEM - FCID TM 

### , Version 2.03 ) which use s food consumption data from the U.S. Department of Agriculture’s Continuing Survey s of Food Intakes b y Individuals (CSFII) from 1994 - 1996 and 1998. The anal ys is was performed to support a requested Section 3 registration u se of the miticide acequinocyl (2 - (acet yl oxy) - 3 - dodecyl - 1,4 - naphthalenedione) on the following crops: succulent soy bean vegetable; succulent shelled beans; cowpea forage; caneberry subgroup 13 - 07A; melon subgroup 9A; cucumber ; cherry ; low - growing berry subgroup 13 - 07G; and small fruit v ine climbing, except fuzzy kiwifruit, subgroup 13 - 07F . An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established. A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans. Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization Tolerance - level residues and 100 percent crop treated (%CT) data were used in the chronic dietary assessment. DEEM  

### ver. 7.81 default processing factors were used with the exception of those for grape juice and raisins (see “Residue Information” Section of this document for details). For the chronic dietary assessment, the general U.S. population and all population subgroups have risk estimates that are not of concern to HED. The chronic dietary risk estimate for the U.S. population is 1 3 % of the chronic population - adjusted dose (cPAD). The highest exposed population subgroup (children 1 - 2 y ears old) occupies 55 % of the cPAD. The use of anticipated residues (ARs), empirical processing factors, and %CT would refine further HED’s exposure and risk estimates ; however, refinement is not needed at this time. **I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concl uded will result in no unreasonable adverse health effects). This dose is referred to as the population - adjusted dose (PAD). The PAD is equivalent to point of departure (POD, NOAEL , LOAEL, e.g.) divided by the required uncertainty

or safet y factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one m illion . References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: 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 acequinocyl was conducted by Sarah Lev y ( 25 - AUG - 20 10 ; D3 69101 ).Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### II. **Residue Information** Under PP1E7864, the Interregional Research Project No.4 (IR - 4), on behalf of the Agricultural Experiment Station of TX, CA, OR, PA, GA, NM, OK, TN, UT, MI, FL, and AZ, is requesting the establishment of tolerances for combined residues of the insecticide acequinocyl, and its metabolite, 2 - dodecyl - 3 - hydrox y - 1,4 - naphthoquinone (acequinocyl - OH) , expressed as acequinocyl equivalents in/on the following commodities: succulent soy bean vegetable; succulent shelled beans; cowpea forage; caneberry subgroup 13 - 07A; melon subgroup 9A; cucumber ; cherry; low - growing berry subgroup 13 - 07G; and small fruit vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F. No new data were submitted to support tolerances on succulent so ybean vegetables, low growing berry 13 - 07G crop subgroup, or small fruit vine cli mbing subgroup 13 - 07F, except fuzzy kiwifruit. The petitioner has requested that existing tolerances be expanded to these respective crops or crop groups. Permanent tolerances are currentl y established under 40 CFR §180.599(a) for the combined residues o f acequinocyl and its metabolite, acequinocyl - OH , expressed as acequinocyl equivalents, in/on a number of plant and livestock commodities. Tolerances for plant commodities range from 0.02 ppm (tree nuts and pistachios) to 30 ppm (citrus oil), and tolerances for livestock commodities are established at 0.02 ppm in the fat and liver of cattle, goat, horse, and sheep. Based on the structural similarity of acequinocyl - OH to parent and the presence of acequinocyl OH at quantifiable levels in crops, the HED Metabolism Assessment Review Committee (MARC) concluded that parent and acequinocyl - OH are the residues of concern for risk assessment and tolerance expression in apples, oranges, and eggplant commodities (Memo, S. Lev y, 07 - JAN - 2004; D297872). For purposes of this petition, HED will allow translat ion of these results to caneberries, cantaloupe, cherry , and cucumber as these are fruit crops . In addition, HED is willing to translate the results to succulent shelled bean s because beans are low consumption food item s . However, if in the future the petitioner requests new uses where apple, orange, and eggplant metabolism data cannot be translated, HED may ask for additional plant metabolism data. The qualitative nature of acequinocyl residues in ruminants is understood based on an adequate goat metabolism study

(Memo, S. L ev y, 10 - MAR - 2004; D284757). The metabolism of acequinocyl in goats appears to involve the loss of the acetyloxyl moiet y t o form acequinocyl OH and parti al cleavage of the dodecyl side chain to form AKM - 15. Opening and degradation of the quinone ring was also evidenced b y the presence of AKM - 18 and phthalic acid. The MARC concluded that for tolerance expression, the residues of concern in livestock commo dities include parent and acequinocyl - OH. For risk assessment purposes, the residues of concern in livestock commodities are parent and acequinocyl - OH (for liver and kidney , metabolite AKM - 15 is to be included as well (Memo, S. L ev y, et al. , 07 - JAN - 2004; D297872 )). Metabolism data on poultry are not required at the present time as none of the proposed or existing uses of acequinocyl are on crops having regulated poultry feedstuffs.Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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Page 4 of 13 **Table 1. Residues of Concern in Crops, Ruminants, and Drinking Water. Matrix**  **Tolerance Expression Residues for Risk Assessment**  Fruit Crops Acequinocyl + Acequinocyl - OH (R1) Acequinocyl + Acequinocyl - OH (R1) Ruminants Acequinocyl + Acequinocyl - OH (R1) Acequinocyl + Acequinocyl - OH (R1). In liver and kidney, also include AKM - 15. Rotational Crops N ot Determined * N ot Determined * Drinking Water NA ** Acequinocyl + Acequinocyl - OH (R1) * A confined rotational crop study has been revie wed and a 30 - day plant - back interval has been recommended ( Mem o, S. Levy, 25 - JUN - 20 08 ; DP# 351336 ). ** NA = not applicable. 

### Residue Data used for the Chronic Assessment: Tolerance - level residues and 100%CT data were used in the chronic dietary assessment. DEEM  

### ver. 7.81 default processing factors were used with the exception of those for grape juice and raisins. As residues were reduced in both grape juice (<0.02x) and raisin (0.15x), separate tolerances are not required for these commodities . T he DEEM  

### ver. 7.81 default processing factors for juice and raisin were set to 1 as concentrat ion was shown not to occur (Memo, S. Lev y, 05 - SEP - 2007; D342805). As cowpea forage and hay are significant feedstuff for livestock (dairy cattle only), the maximum reasonable balanced diet (MRBD) for acequinocyl was recalculated for this petition using th e Agency ’s most recent guidance on constructing reasonably balanced l ivestock diets ( Science Advisory

Council for Chemistry

(ChemSAC) memo , 30 - JUN - 20 08). The beef cattle MRBDs did not need to be recalculated as cowpea forage and hay are not beef feed item s. The feeding stud y data indicate that the currently established tolerance level of 0.02 ppm for residues in cattle, goat, horse, and sheep fat is app ropriate. Furthermore, the 0.02 - ppm residue level is suffi ci ent to cover residues of the additional metabolite (AKM - 15 ) of concern in ruminant liver and kidney . The established 0.02 - ppm residue level in cattle, goat, horse, and sheep liver are appropriate; however, the commodity definition should be changed to “meat by products” rather than “liver . ” With the establishment of the cattle, goat, horse, and sheep tolerance in meat by products, RD should remove the tolerance for liver. See Table 2 for a summary of the data used in the chronic assessment. **Table 2. Data and Residue Estimate s Used in the Acequinocyl Chronic Dietary Analyses.**  **Comm odity**  **Data Source (M**  **RID) %CT**  **Processing Factors**  **HED -**  **Recommended**

**Tolerance (ppm)** Bean, succulent shelled 1 4846290 1 100 NA 0.30 Caneberry subgroup 13 - 07A 48462902 NA 4.0 Melon subgroup 9A 48462903 NA 0.15 Cucumber 48462905 NA 0.15 Cherry, sweet 48462904 NA 0.50 Cherry, tart2 NA 1.0 Soy bean, vegetable, succulent Translated from established edible podded bean tolerance NA 0.25Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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Page 5 of 13 **Table 2. Data and Residue Estimate s Used in the Acequinocyl Chronic Dietary Analyses.**  **Comm odity**  **Data Source (M**  **RID) %CT**  **Processing Factors**  **HED -**  **Recommended**

**Tolerance (ppm)** Lo w growing berry subgroup13 - 07G 3 Translated from established straw

berry tolerance NA 0.50 Sm all fruit vine climbing subgroup 13 - 07F, except fuzzy kiwifruit Translated from established grape tolerance NA 1.6 Meat byproducts of cattle, goat, horse, and sheep Extended from liver NA 0.02 1 HED is recommending for cow pea forage and cow

pea hay tolerances of 6.0 ppm and 18 ppm, respectively, however, these are feed items and are not in DEEM - FCID TM

. 2 The value for cherry, tart was used as the input in DEEM - FCID TM as the HED - recommended tolerance value was higher than the value for cherry, sweet. 3 The established straw

berry tolerance is 0.40 ppm ; however, for purposes of harmonization with Canada, HED is recommending to increase the tolerance to 0.50 ppm for this crop sub group. 

### III. **Drinking Water Data**  The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) ( M . L owit , 07 - SEP - 2011 ; D 389520 ) and incorporated directl y into this dietary assessment. Water residues were incorporated directl y into DEEM - FCID TM 

### under the food categories “water, direct, all sources” and “water, indirect, all sources.” Acequinocyl can reach surface water via spray drift and less likely

via runoff. Due to its high Kd 

### values it is expected to exhibit low mobility in soil and low potential to leach into groundwater. Once acequinocyl has entered surface water, it is not likely to persist as it will hydrol yz e to form hydrox y - acequinocyl (also known as R - 1). There are no drinking water monitoring data available for acequinocyl or its metabolite acequinocyl - OH (R1), the residues of concern. Groundwater estimated drinking water concentrations (EDWCs) were generated for ace quinocyl using the Screening Concentration in Ground Water (SCI - GROW ) Model . Surface water EDWCs were generated using the Pesticide Root Zone Model/Exposure Anal ys is Modeling Sy stem (PRZM/EXAMS) model for all proposed uses except cranberry

(cranberries ar e part of the low growing berries subgroup, 13 - 07G) . Cranberry

harvesting may

involve field flooding and PRZM/EXAMS is not currentl y parameterized to assess this ty pe of scenario; therefore, cranberry was assessed using the provisional cranberry

model (no te that since the provisional cranberry model only

uses a one ye ar simulation, the highest 30 - ye ar annual average concentration is not available for the cranberry scenario). Similar to previous drinking water assessments provided by EFED, two approaches w ere used in performing the drinking water assessment for proposed acequinocyl uses. In Approach #1 , acequinocyl was conservatively assumed to be stable to all routes of degradation to account for the uncertainties associated with the environmental fate data. In Approach #2 , total (acequinocylAcequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### + acequinocyl - OH) residues were modeled with the assumption that the half - lives of acequinocyl and R1 are valid and the total toxic residues were modeled to address toxicity concerns with R1. The EDWCs are summarized below i n Table 3. Surface water EDWCs for the proposed uses are higher than those previously rep orted for both approaches. The ground water EDWC for the current assessment is the same as the last assessment. **Table 3. Recommended EDWCs of Acequinocyl Derived from the Previous Uses.** Drinking water source (model) Proposed

Use/Scenario 3 EDWCs from Surface Water Sources (ug/L) 1,2 Approach 1 (assume no acequinocyl degradation) Approach 2 (combined acequinocyl and R1) 1 - in - 10 year acute 1 - in - 10 year

chronic 30 - year

mean 1 - in - 10

year acute 1 - in - 10 year

chronic 30 - year

mean Surface water (PRZM/EXAMS) Cherry/MI cherry **6.69** (25.89) 4 **6.69**

(17.84) 4 **6.69**

(10.19) 4 **5.59** 0.42 0.26 Surface water (PRZM/EXAMS) Small fruit (vine

climbing, except fuzzy kiwifruit, 13 - 07F)/NY grape **6.69** (23.12) 4 **6.69**

(15.34) 4 **6.69**

(9.57) 4 4.22 0.38 **0.27** Surface water (Provisional Cranberry Model) Cranberry/Provisional

Cranberry Model 4.24 3.75 -- 3.81 5 **1.36** 5

-- Groundwater (SCIGROW) All proposed uses 3.6 x 10 - 3 < 3.6 x 10 - 3 < 3.6 x 10 - 3 3.6 x 10 - 3 < 3.6 x 10 - 3 < 3.6 x 10 - 3 1 Bolded values are the recommended EDWCs by EFED. 2 A default PCA of 0.87 w as applied. 3 Maximum of 2 applications of 0.3 lb ai/A for all proposed uses. 4 EDWC (shown in parentheses ) exceeds the solubility limit of acequinocyl (6.69 μg/L at 20°C ); therefore, the recommended EDWC is 6. 69 ppb. 5 Based on a one - year simulation; 1 - 10 y ear calculation is not applicable. 

### Since the surface water EDWCs are higher than the groundwater EDWC, HED selected the surface water value for use in the chronic dietary assessment. The EDWC derived vi a Approach #1 represents the upper - bound value ( 6.69 ppb) while that derived via Approach #2 represents the lower - bound value ( 1.36 ppb ). The 6.69 ppb value was used in th is dietary assessment as this value assures a conservative assessment. **IV. DEEM**  **- FCID**  **TM** 

### Program and Consumption Information An a cequinocyl chronic dietary exposure assessment w as conducted using DEEM - FCID TM 

### , Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994 - 1996 and 1998. The 1994 - 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g. , apples, peeled fruit - cooked; fresh 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 assessme nt, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analy sis of the 1994 - 96, 98 CSFII consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: theAcequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### general U.S. population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 1 9, adults 20 - 49, females 13 - 49, and adults 50+ y ears old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average da ily

consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg bod y weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup. **V. Toxicological Information**  On 14 - OCT - 2003, the HED Hazard Identif ication Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for acequinocyl with regard to the acute and chronic RfDs and the toxicological endpoint selection for use as appropriate in occupational/residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to acequinocyl was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996 under the 2002 OPP 10X Guidance. Table 4 is a summary of the toxicology

doses and endpoints selected that are relevant to dietary exposure assessment (13 - NOV - 2003 ; TXR# 0052234 ). The acequinocyl risk assessment team confirmed that the endpoints selected previously remain appropriate. **Table 4. Summary of Toxi cological Doses and Endpoints for Acequinocyl for Use in Dietary Exposure Risk**  **Assessment.** 1 **Exposure/ Scenario**  **Point of**

**Departure Uncertainty/** 

**FQPA Safety Factors**  **RfD, PAD, Level of**

**Concern Study and Toxicological Effects**  Ac ute Dietary (General Population, including Infants and Children) N/A N/A N/A An endpoint of concern (effect) attributable to a single dose was not identified in the database. Quantification of acute risk to general population including infants and children is not required. Chronic Dietary (All Populations) NOAEL=

2.7 mg/kg/day UF A= 10x

UF H =10x FQPA SF= 1x cPAD = cRfD =

0.027 mg/kg/day 18 - mo nth carcinogenicity study in

mice; LOAEL=7.0 mg/kg/day based on clinical chemistry and microscopic nonneoplastic lesions (brown pigmented cells and perivascular inflammatory cells in liver) Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans.” 1 UF = uncertainty factor, UF A = extrapolation from animal to human (interspecies), UF H = potential variation in sensitivity among members of the human population (intraspecies), FQPA SF = FQPA Safety Factor, NOAEL = no observed adverse - effect level, LOAEL = lowest - observed adverse - effect level, RfD = reference dose (a = acute, c = chronic), PAD = population - adjusted dose, N/A = Not Applicable.Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### VI. **Results/Discussion** As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCID TM 

### analy ses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 5 are for the general U.S. Population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ years. An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established. A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans. The chronic dietary

exposure assessment (using tolerance level residues and 100% CT information for all registered and proposed uses) was conducted for the general U.S. population and various population subgroups. Drinking water was incorporated directly into the dietary assessment using the chronic concentration for ground water generated b y the PRZM/EXAMS model. This assessment concludes that the chronic dietary risk estimates are not of concern to HED for the general U.S. population ( 13 % cPAD) and all population subgroups. The most highl y exposed population subgroup is children 1 - 2 y ears old at 55 % of the cPAD. **Table 5**  **. Summary of Dietary (Food**  **+ Drinking Water)**  **Exposure and Risk for Acequinocyl. Population Subgroup**  **Chronic Dietary 1**  **Dietary Exposure**  **(m g/kg/day)**  **% cPAD** U.S. Population (total) 0.00 3627 1 3 All Infants (<1 year old) 0.00 6 513 2 4 **Children 1 -**  **2 years old 0.01**  **4 761**  **55** Children 3 - 5 y ears old 0.0 10370 3 8 Children 6 - 12 y ears old 0.00 5 172 1 9 Youth 13 - 19 y ears old 0.00 2 825 11 Adults 20 - 49 y ears old 0.00 2525 9.4 Adults 50+ years old 0.00 2 4 7 3 9.2 Fem ales 13 - 49 y ears old 0.00 2 5 63 9. 5 1 Chronic dietary endpoint of 0.027 mg/kg/day applies to the general U.S. population and all population subgroups . T he values for the highest exposed population are bolded . 

### VII. **Characterization of Inputs/Outputs** The chronic anal ys is assumed tolerance - level residues and 100%CT data. DEEM  

### ver. 7.81 default processing factors were used with the exception of those fo r grape juice and raisins. This anal ys is is considered very conservative and could be refined through the use of ARs for all commodities, %CT data for registered commodities, and/or additional empirical processing factors.Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### V **I I**  **I. Conclusions**  A chronic dietary

exposure and risk assessment was conducted for the proposed food uses and permanent tolerances of acequinocyl, including potential exposure from drinking water. The chronic dietary

(food + drinking water) exposure to acequinocyl is bel ow HED’s level of concern for the general U.S. population and all population subgroups. The chronic dietary r isk utilized 1 3 % cPAD for the general U.S. population and 55 % of the cPAD for children 1 - 2 y ears old, the most highly

exposed population subgroup. An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established. A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans. **IX .**  **List of Attachments** Attachment 1: Chronic Food + Drinking Water Residue Input File. Attachment 2: Chronic Results File.

cc: M. Lowit (EFED /ERB 1 ; 7507P ) RDI: DESAC ( 09 - NOV - 201 1 ) ; G.F. Kramer ( 09 - NOV - 201 1 ) S. Levy:S10953:PY1:(703)305 - 0783:7590PAcequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### Attachment 1: Chronic Food **+ Drinking Water Residue Input File.**  Filename: C: \ Documents and Settings \ slevy \ Desktop \ 006329c_SL.R98 Chemical: Acequinocyl RfD(Chronic): .027 mg/kg bw/day NOEL(Chronic): 2.7 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 11 - 16 - 2011/08:07:44/8 Program ver. 2.03 Comment: No acute dietary endpoint; not carcinogen. cRfD=cPAD

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

-------- ---- ------------------- ------------ ---------- ------ ------ ------- 06003470 6 Soybean, seed 0.250000 1.000 1.000 1E7864 06010430 6A Bean, snap, succulent 0.250000 1.000 1.000 9E7598 06010431 6A Bean, snap, succulent - babyfood 0.250000 1.000 1.000 9E7598 06020310 6B Bean, broad, succulent 0.250000 1.000 1.000 1E7864 06020330 6B Bean, cowpea, succulent 0.250000 1.000 1.000 1E7864 06020370 6B Bean, lima, succulent 0.250000 1.000 1.000 1E7864 08001480 8 Eggplant 0.700000 1.000 1.000 9E7598 08002340 8 Okra 0.700000 1.000 1.000 9E7598 08002700 8 Pepper, bell 0.700000 1.000 1.000 9E7598 08002701 8 Pepper, bell - babyfood 0.700000 1.000 1.000 9E7598 08002710 8 Pepper, bell, dried 0.700000 1.000 1.000 9E7598 08002711 8 Pepper, bell, dried - babyfood 0.700000 1.000 1.000 9E7598 08002720 8 Pepper, nonbell 0.700000 1.000 1.000 9E7598 08002721 8 Pepper, nonbell - babyfood 0.700000 1.000 1.000 9E7598 08002730 8 Pepper, nonbell, dried 0.700000 1.000 1.000 9E7598 08003740 8 Tomatillo 0.700000 1.000 1.000 9E7598 08003750 8 Tomato 0.700000 1.000 1.000 9E7598 08003751 8 Tomato - babyfood 0.700000 1.000 1.000 9E7598 08003760 8 Tomato, pas te 0.700000 5.400 1.000 9E7598 08003761 8 Tomato, paste - babyfood 0.700000 5.400 1.000 9E7598 08003770 8 Tomato, puree 0.700000 3.300 1.000 9E7598 08003771 8 Tomato, puree - babyfood 0.700000 3.300 1.000 9E7598 08003780 8 Tomato, dried 0.700000 14.300 1.000 9E7598 08003781 8 Tomato, dried - babyfood 0.700000 14.300 1.000 9E7598 08003790 8 Tomato, juice 0. 700000 1.500 1.000 9E7598 09010750 9A Cantaloupe 0.150000 1.000 1.000 1E7864 09010800 9A Casaba 0.150000 1.000 1.000 1E7864 09011870 9A Honeydew melon 0.150000 1.00 0 1.000 1E7864 09013990 9A Watermelon 0.150000 1.000 1.000 1E7864 09014000 9A Watermelon, juice 0.150000 1.000 1.000 1E7864 09021350 9B Cucumber 0.150000 1.000 1.000 1E7 864 10001060 10 Citrus citron 0.200000 1.000 1.000 10001070 10 Citrus hybrids 0.200000 1.000 1.000 10001080 10 Citrus, oil 30.000000 1.000 1.000 10001800 10 Grapefruit 0.200000 1.000 1.000 10001810 10 Grapefruit, juice 0.200000 2.100 1.000 10001970 10 Kumquat 0.200000 1.000 1.000 10001990 10 Lemon 0.200000 1.000 1.000 10002000 10 Lemon, juice 0.200000 2.000 1.000 10002001 10 Lemon, juice - babyfood 0.200000 2.000 1.000 10002010 10 Lemon, peel 0.200000 1.000 1.000 10002060 10 Lime 0.200000 1.000 1.000 10002070 10 Lime, juice 0.200000 2.000 1.000 10002071 10 Lime, juice - babyfood 0.200000 2. 000 1.000 10002400 10 Orange 0.200000 1.000 1.000 10002410 10 Orange, juice 0.200000 1.800 1.000 10002411 10 Orange, juice - babyfood 0.200000 1.800 1.000 10002420 10 Oran ge, peel 0.200000 1.000 1.000 10003070 10 Pummelo 0.200000 1.000 1.000 10003690 10 Tangerine 0.200000 1.000 1.000 10003700 10 Tangerine, juice 0.200000 2.300 1.000 11000070 11 Apple, fruit with peel 0.400000 1.000 1.000 11000080 11 Apple, peeled fruit 0.400000 1.000 1.000 11000081 11 Apple, peeled fruit - babyfood 0.400000 1.000 1.000Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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Page 11 of 13 11000 090 11 Apple, dried 0.400000 8.000 1.000 11000091 11 Apple, dried - babyfood 0.400000 8.000 1.000 11000100 11 Apple, juice 0.400000 1.300 1.000 11000101 11 Apple, juice - babyfood 0.400000 1.300 1.000 11000110 11 Apple, sauce 0.400000 1.000 1.000 11000111 11 Apple, sauce - babyfood 0.400000 1.000 1.000 11001290 11 Crabapple 0.400000 1.000 1.000 11002100 11 Loquat 0.400000 1.000 1.000 11002660 11 Pear 0.400000 1.000 1.000 11002661 11 Pear - babyfood 0.400000 1.000 1.000 11002670 11 Pear, dri ed 0.400000 6.250 1.000 11002680 11 Pear, juice 0.400000 1.000 1.000 11002681 11 Pear, juice - babyfood 0.400000 1.000 1.000 11003100 11 Quince 0.400000 1.000 1.000 12000900 12 Cherry 1.000000 1.000 1.000 1E7864 12000901 12 Cherry - babyfood 1.000000 1.000 1.000 1E7864 12000910 12 Cherr y, juice 1.000000 1.500 1.000 1E7864 12000911 12 Cherry, juice - babyfood 1.000000 1.500 1.000 1E7864 13010550 13A Blackberry 4.000000 1.000 1.000 1E7864 13010560 13A Blackberry, juice 4.000000 1.000 1.000 1E7864 13010561 13A Blackberry, juice - babyfood 4.000000 1.000 1.000 1E7864 13010580 13A Boysenberry 4.000000 1.000 1.000 1E7864 13011420 13A Dewberry 4.000000 1.000 1.000 1E7864 13012080 13A Loganberry 4.000000 1.000 1.000 1E7864 13013200 13A Raspberry 4.000000 1.000 1.000 1E7864 13013201 13A Raspberry - babyfood 4.000000 1.000 1.000 1E7864 13013210 13A Raspberry, juice 4.000000 1.000 1.000 1E7864 13013211 13A Raspberry, juice - babyfood 4.000000 1.000 1.000 1E7864 13020570 13B Blueberry 0.500000 1.000 1.00 0 13020571 13B Blueberry - babyfood 0.500000 1.000 1.000 14000030 14 Almond 0.020000 1.000 1.000 14000031 14 Almond - babyfood 0.020000 1.000 1.000 14000040 14 Almond, oil 0.020000 1.000 1.000 14000041 14 Almond, oil - babyfood 0.020000 1.000 1.000 14000590 14 Brazil nut 0.020000 1.000 1.000 14000680 14 Butternut 0.020000 1.000 1.000 14000810 14 Cashew 0.020000 1.000 1.000 14000920 14 Chestnut 0.020000 1.000 1.000 14001550 14 Filbert 0.020000 1.000 1.000 14001560 14 Filbert, oil 0.020000 1.000 1.000 14001850 14 Hickory nut 0.020000 1.000 1.000 14002130 14 Macadamia nut 0.020000 1.000 1.000 14002690 14 Pecan 0.020000 1.000 1.000 14002820 14 Pistachio 0.020000 1.000 1.000 14003910 14 Walnut 0.020000 1.000 1.000 21000460 M Beef, meat byprod ucts 0.020000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.020000 1.000 1.000 21000470 M Beef, fat 0.020000 1.000 1.000 21000471 M Beef,fat - babyfood 0.020000 1. 000 1.000 21000480 M Beef, kidney 0.020000 1.000 1.000 21000490 M Beef, liver 0.020000 1.000 1.000 21000491 M Beef, liver - babyfood 0.020000 1.000 1.000 23001710 M Goat , fat 0.020000 1.000 1.000 23001720 M Goat, kidney 0.020000 1.000 1.000 23001730 M Goat, liver 0.020000 1.000 1.000 26003400 M Sheep, meat byproducts 0.020000 1.000 1.000 26003410 M Sheep, fat 0.020000 1.000 1.000 26003411 M Sheep, fat - babyfood 0.020000 1.000 1.000 26003420 M Sheep, kidney 0.020000 1.000 1.000 26003 430 M Sheep, liver 0.020000 1.000 1.000 86010000 O Water, direct, all sources 0.006690 1.000 1.000 1E7864 86020000 O Water, indirect, all sources 0.006690 1.000 1.000 1E7864 95001300 O Cranberry 0.500000 1.000 1.000 1E7864 95001301 O Cranberry - babyfood 0.500000 1.000 1.000 1E7864 95001310 O Cranberry, dried 0.500000 1.000 1.000 1E7864 95001320 O Cranberry, juice 0.500000 1.100 1.000 1E7864 95001321 O Cranberry, juice - babyfood 0.500000 1.100 1.000 1E7864Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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Page 12 of 13 95001750 O Grape 1.600000 1.000 1.000 95001760 O Grape, juice 1.60000 0 1.000 1.000 95001761 O Grape, juice - babyfood 1.600000 1.000 1.000 95001770 O Grape, leaves 1.600000 1.000 1.000 95001780 O Grape, raisin 1.600000 1.000 1.000 95001790 O Grape, wine and sherry 1.600000 1.000 1.000 95001880 O Hop 4.000000 1.000 1.000 9E7598 95001950 O Kiwifruit 1.600000 1.000 1.000 1E7864 95003590 O Straw berry 0.500000 1.000 1.000 1E7864 95003591 O Strawberry - babyfood 0.500000 1.000 1.000 1E7864 95003600 O Strawberry, juice 0.500000 1.000 1.000 1E7864 95003601 O Strawberry, juice - babyfood 0.500000 1.000 1.000 1E7864Acequinocyl Dietary Exposure and Risk Assessment DP# 389990

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### Attachment 2: Chronic Results File. U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for ACEQUINOCYL (1994 - 98 data) Residue file nam e: C: \ Documents and Settings \ slevy \ Desktop \ 006329c_SL.R98 Adjustment factor #2 used. Analysis Date 11 - 16 - 2011/09:05:55 esidue file dated: 11 - 16 - 2011/08:07:44/8 Reference dose (RfD, Chronic) = .027 mg/kg bw/da y COMMENT 1: No acute dietary endpoint; not carcinogen. cRfD=cPAD

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

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

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

----------------------------------- ------------- --------------- U.S. Population (total) 0.003627 13.4% U.S. Population (spring season) 0.003565 13.2% U.S. Population (summer season) 0.003721 13.8% U.S. Population (autumn season) 0.003572 13.2% U.S. Population (winter season) 0.003653 13.5% Northeast region 0.004098 15.2% Midwest region 0.003612 13.4% Southern region 0.003232 12.0% Western region 0.003850 14.3% Hispanics 0.003984 14.8% Non - hispanic whites 0.003597 13.3% Non - hispanic blacks 0.003467 12.8% Non - hisp/non - white/non - black 0.003724 13.8% All infants (< 1 year) 0.006513 24.1% Nursing infants 0.003204 11.9% Non - nursing infants 0.007769 28.8% Children 1 - 6 yrs 0.011306 41.9% Children 7 - 12 yrs 0.004806 17.8% Females 13 - 19 (not preg or nursing) 0.002860 10.6% Females 20+ (not preg or nursing) 0.002497 9.2% Females 13 - 50 yrs 0.002791 10.3% Females 13+ (preg/not nursing) 0.002783 10.3% Females 13+ ( nursing) 0.002812 10.4% Males 13 - 19 yrs 0.002783 10.3% Males 20+ yrs 0.002507 9.3% Seniors 55+ 0.0 02472 9.2% Children 1 - 2 yrs 0.014761 54.7% Children 3 - 5 yrs 0.010370 38.4% Children 6 - 12 yrs 0.005172 19.2% Youth 13 - 19 yrs 0.002825 10.5% Adults 20 - 49 yrs 0.002525 9.4% Adults 50+ yrs 0.002473 9.2% Females 13 - 49 yrs 0.002563 9.5%