### Page 1 of 16 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 **OFFICE OF CHEMICA**  **L SA FETY**  **AND POLLUTION PREVENTION**  

### M **EMORANDUM** Date: April 22 , 201 4 SUBJECT: **Fluopicolide .**  Chronic Aggregate Dietary Exposure Assessment of Food and Drinking Water to Support a Petition for an Increased Tolerance on Tuberous and Corm Subgroup 1C Vegetables

. **PC Code:** 027412 **DP Barcode:** D 417355 **Decision No.:** 481092 **Registration No. :**  59639

- 139 **Petition No.:** 3F8191 **Regulatory Action:** Section 3 **Risk Assessment Type:** Single Chemical, Dietary **Case No.:** NA T **XR No.:** NA **CAS No.:** 2008

- 54

- 4 **MRID No.:** None **40 CFR:** §180. 6 27


### FROM: Peter Savoia, Chemist

Risk Assessment Branch V Health Effects Division (7509P) THRU: Michael S. Metzger, Branch Chief

Risk Assessment Branch V Health Effects Division (7509P)

And Dennis McNeill y, Chemist Meheret Negussie , Chemist Dietary Exposure Science Advisory Council Health Effects Division (7509P) TO: Tony

Kish, Risk Manager Dominic Schuler, Risk Manager Reviewer Fungicide Branch Registration Division (7505P) **Executive Summary** A chronic aggregate dietary food and drinking water exposure and risk assessment w as conducted using the Dietary

Exposure Evaluation Model software with the Food Commodity I ntake 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/WWEI A). The anal yses were performed to evaluate the proposed tolerance increase on tuberous and corm subgroup 1C vegetables fro m 0.02 ppm to 0.3 ppm. This action is being sought to prevent the possible seizure of commodities for over tolerance residues which were legall y treated with an earl y season soil application that has since been restricted. This memorandum w as reviewed by two peer reviewers of the DESAC, per DESAC Standard Operating Procedures ( SOP ) 2012.1.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 2 of 16 Acute Dietary

Exposure Assessment An acute dietary

exposure anal ys is and risk assessment was not conducted because an endpoint attributable to a single d ose has not been identified for fluopicolide. Chronic Dietary

Exposure Assessment Th e chronic dietary

exposure anal ys is and risk assessment made i s a conservative determination that use s tolerance level residues or maximum field trial residues and a 100% crop treated assumption

. Dietary risk estimates were determined considering exposures from food and drinking water using estimated drinking water concentrations (EDWCs) for all direct and indirect water sources pr ovided by the Environmental Fate and Eff ects Division ( EFED )

. The chronic risk estimates for fluopicolide are below the Agency ’s level of concern for the general U.S. population and all population subgroups ( i.e. , <100% of the chronic population adjusted dose) . The most highl y exposed populati on subgroup is children ages 1

- 2 with an estimate for fluopicolide for food and water of 1 3 % of the cPAD. Cancer Dietary

Exposure Assessment A cancer dietary

exposure and risk assessment was not conducted since fluopicolide is not likely to be carcinogenic to humans. **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 equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided b y 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 Infor mation 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

- 1 999). The most recent dietary

exposure analy sis of fluopicolide was conducted in support of the Section 3 registration action to establish tolerances on rotational corn (D 407936 , A. Kamel , 0 4 / 08 /20 1 3 ). **II. Residue Information**  The Valent U.S.A. Corporati on has submitted PP# 3F8191 which requests to increase the tolerances on tuberous and corm subgroup 1C vegetables and potato processed waste for the fungicide fluopicolide. This action is being requested since there is a potential for fluopicolide limits to be exceeded because of an unintentional labeling error which allowed for soil directed applications to be made on potatoes. Fluopicolide is a fungicide active ingredient used for the control of plant diseases caused b y Oom yc etes. Permanent t olerances are established under 40 CFR §180. 627 for residues of fluopicolide which include levels previousl y determined on potatoes for post

- emergence foliar applications. To accommod ate directed soil applications to potatoes, Valent is currently conducting field trials and will submit these data as soon as they become available. In the interim, modeling data were submitted which are concluded to be adequate for estimating residue con centrations that may be found in potato tubers as a result of this added use (MRI D No. 49177301)

.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 3 of 16 The fluopicolide residues of concern for primary and rotational crops, livestock and drinking water are shown in Table 1. **Table 1. Summary of Fluopicolide Residues of Concern.**  **Matrix Residues included in Risk**  **Assessment Residues included in**  **Tolerance Expression**

Plants Primary Crops

All primary crops except Tuberous and Corm Vegetables Fluopicolide (parent) and BAM Fluopicolide Tuberous and Corm Vegetables Fluopicolide (parent), PCA, and BAM Rotational Crops All rotational crops except cereal grains Fluopicolide (parent) and BAM Fluopicolide Cereal grains

- grain for human food Fluopicolide (parent), PCA, P1X and BAM Cereal grains

- forage/hay/straw and grain for livestock feed Fluopicolide (parent) and BAM Livestock Fluopicolide (parent) and BAM Fluopicolide 1 Drinking Water Fluopicolide (parent) and BAM Not applicable 1 Upon submission of additional information, the Fluopicolide Team revisited the residues of concern in animal commodities and determined that the tolerance should be expressed as parent compound and that the ROC for risk assessment purposes w as parent and BAM. (D370762, D. Davis, 8/19/10) 

### In determinin g the residues of concern , fluopicolide was concluded to share a common metabolite, BAM with another active ingredient dichl o benil. For risk assessment purposes, a determination is also needed to evaluate if BAM residues resulting from this new use of the parent compound will impact dietary exposure . For the prior action which registered the foliar use of fluopicolide on potatoes, a separate dietary risk assessment was completed for the BAM metabolite (D381051 and D381052, D. S. Davis, 09/09/2010). These results found that the addition of this use for fluopicolide did not significantl y impact the overall dietary assessment. Further, when fluopicolide is applied, very little is converted to BAM in contrast to the use of dichlobenil which results in much h igher residues. As such, there is no expectation that BAM residues will result from allowing soil directed treatments to be made to potatoes as well . The prior BAM dietary exposure anal ys is and risk assessment is th erefore concluded to be adequate in sup porting this petition. All other metabolites referenced above are assumed to have equivalent or less toxicity than the parent compound and will be included with the parent compound in this dietary risk assessment. For this dietary

assessment, tolerance level residues were utilized for the established uses of fluopicolide except for rotational wheat commodities, and tuberous and corm vegetables. Maximum residue values w ere used for these crops since metabolite concentrations are required to be included for risk assessment. In regard to rotational wheat commodities, the maximum residues from the field trial data were used to calculate an appropriate residue value since the parent compound along with the PCA and P1X metabolites are used for risk assessment
. The m aximum metabolite residues obtained were converted to parent equivalents and added to the maximum fluopicolide residue value observed in the field tr ia l data to derive a total residue value. The total residue calculations for rotational wheat commodities were carried forward from the previous dietary assessment made for fluopicolide on these commodities (D381050, D. S. Davis, 08/19/2010). The rotational wheat total residue calculations are shown below in Table 2.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 4 of 16 **Table 2. Calculation of Fluopicolide Residues of Wheat for Dietary Assessment.**  **1**

**Matrix Residues of**  **Concern for Risk Assessment**  **2 Max Reported** 

**Residues (ppm)**  **Conversion**

**Factors 3**  **Max Residues**

**Expressed as Parent**  **Equivalents (ppm)**  Wheat grain Parent 0.014 Not applicable 0.014 PCA 0.062 1.701 0.10546 P1X 0.075 1.515 0.1136 **Total** 0.2331 ≈ **0.23** Wheat germ Parent 0.014 Not applicable 0.0658 PCA 0.10546 1.701 0.09491 P1X 0.1136 1.515 0.07952 **Total** 0.24023 ≈ **0.24** Wheat bran Parent 0.014 Not applicable 0.0420 PCA 0.10546 1.701 0.2004 P1X 0.1136 1.515 0.2499 **Total** 0.4923 ≈ **0.49** 1 Rotational wheat commodities w ere previously assessed in a separate memo (D38105 0 , D. S. Davis, 0 8 / 1 9/2010)

. 2 BAM is assessed in a separate memo (D381051 and D381052, D. S. Davis, 09/09/2010)

. 3 Conversion factors convert residues reported as PCA and P1X to fluopicolide (parent) equivalents using molecular weight ratios. Molecular weights are 383.584 for parent, 225.554 for PCA, and 253.196 for P1X. Conversion factors are calculat ed as follows: 383.584 ÷ 225.554 = 1.701 for conversion of PCA to parent equivalents; 383.584 ÷ 253.196 = 1.515 for conversion of P1X to parent equivalents. 

### In regard to rotational corn , tolerance

- level residues were utilized for assessing these establish ed use s which followed the previous dietary assessment made for fluopicolide on these commodities (D407936, A. Kamel, 04/08/2013) . Empirical processing factors were incorporated, except for corn sy rup where the default processing factor was included. Sin ce metabolite residues of PAC and P1 X were not detected (below the limit of detection, LOD) in grain or processed fractions at the 1x and 2x application rates, half the L OD (0.005 ppm) of each metabolite was added to the residues of the parent fluopicolide for this assessment. As a result, a value of 0.02 ppm was used for corn commodities. For tuberous and corm commodities, an appropriate residue value for risk assessment includes the parent compound and PCA metabolite. In order to estimate the level of fluopicolide that can occur from directed soil application, the registrant has provided modeling calculations for tolerance setting purposes while field trials are completed

. This was represented b y modeling the maximum application rate for directed soil treatment to estimate the percentage of fluopicolide residues which could be translocat ed to potato tubers

. T o obtain a maximum residue value for risk assessment, a ratio was therefore determined for calculating a correlated level of the PCA metabolite

. This was done by evaluating all of the available studies relevant for determining the residues of fluopicolide in root and tuber crops (potato metabolism study , potato field trial studies, and confined rotational crop study ). Upon comparison, the 29 day p lant

- back interval for radish roots which tested the py ridiny l label examined in the confined rotational crop study gave the most conservative ratio (82%). A maximum residue value of 0.54 ppm is therefore used for tuberous and corm vegetables which is determined b y multiply ing the modeled fluopicolide value recommended for tolerance (0.3 ppm) by a factor of 1.8X There are no livestock tolerances required to support the established uses of fluopicolide or for an increased tolerance on tuberous and corm vegetables following this action

. The livestock dietaryFluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 5 of 16 burden was determined to be unaffected b y the increased tolerance which is being recommended on potato processed waste (D417354, P. Savoia, 0 4 / 22 /2014)

. E mpirical data were used to determin e appropriate values for all relevant processed commodities

. DEEM 7.81 default concentration factors were otherwise applied to the raw agricultural commodity residue level in the absence of empirical data. The processing factors used for this chronic dietary exposure and risk assessment are shown in Table 3 below. **Table 3**  **. Summary of Processing Factors Used**  **for Fluopicolide Dietary Analysis.**  **RAC Processed** 

**Comm odity**  **Processing**

**Factor Comment** 

Beet, Sugar Molasses 1.0 MRID 47021707

– Residues of fluopicolide do concentrate slightly in molasses, however, when the highest average field trial (HAFT) is multiplied by the concentration factor of 1.6X, the resulting residue value is below the tolerance set on the RAC. Since the RAC tolerance is used in the assessment, no additional PF is needed.
Grapes Grape Juice 1.0 MRIDs 4647102, 46474104, 46474105, 46708542

– Residues of fluopicolide are not likely to concentrate in juice or w ine. Residues do concentrate in raisins; however a processed commodity tolerance of 6.0 ppm is established for raisins and is used in the ass essm ent; since concentration is already accounted for an additional processing factor is not required. Raisins 1.0 Wine 1.0 Onions Onions,

dehydrated or dry 9.0 DEEM 7.81 default processing factor Potato Flakes & Flour 1.0 MRID 46708545

– Residues of fluopicolide in potato flakes and chips are not likely to exceed the established RAC tolerance. Chips 1.0
Tom ato Tom ato Juice 1.0 MRID 46708543

– Residues of fluopicolide in tomato juice, paste or puree are not likely to exceed the established RAC tolerance. Tom ato Paste 1.0 Tom ato Puree 1.0 Tom atoes, dried 14.3 DEEM 7.81 default processing factor 

### III. Percent Crop Treated Information The dietary

assessment performed in support of this action is considered to be a highly conservative anal ys is. I t includes tolerance level residues or maximum field trial residue levels for all crops, assumes 100% crop treated and uses empirical or defaul t DEEM processing factors. **I V**  **. Drinking Water Data** Estimated D rinking W ater C oncentrations (EDWCs) for fluopicolide were recentl y determined to support the establishment of tolerances on tuberous and corm subgroup 1C vegetables for post

emergence foliar applications. These anal ys es were provided b y the Environmental Fate and Effects Division (EFED) in the memorandum “Tier II Drinking Water Exposure Assessment for Fluopicolide and its Major Degradate, 2,6

- Dichlorbenzamide (BAM) for Use on Potatoes, Carrots, Sugar Beets and Brassica (Cole) Leafy Vegetables ” (D370764, R. Miller, 07 /20/ 20 10)

. The need for updated EDWCs is c urrently being assessed in order to support a p ending new use registration which ha s been recentl y requested. An updated dietary exposure and risk assessment is anticipated which will evaluate all of the established uses of fluopicolide. Inthe interim, the previous drinking water assessment will remain applicable for supporting this current action.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 6 of 16 In the EFED assessment , EDWCs are provided separatel y for the parent compound and its BAM metabolite; however, since this risk assessment includes fluopicolide onl y in drinking water, BAM results are not discussed further here. Fluopicolide is not included as an anal yt e monito red in U.S. surface and groundwater under the USGS’s National Water Quality Assessment (NAWQA) program. Since there is not adequate monitoring data available, surface water concentrations were estimated using the Tier II model PRZM version 3.12/ EXAMS ver sion 2.98. Ground water concentrations were estimated using the Tier I SCI

- GROW model. The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water /

. The recommended estimated drinking water concentrations (EDWCs) for fluopicolide are summarized below in Table 4

. **Table 4**  **. Summary of Estimated Surface Water and Groundwater Concentrations for Fluopicolide. Fluopicolide**  **Surface Water Conc., ppb 1**  **Groundwater Conc., ppb 2**  Ac ute 25.50 0.5 Chronic (non

- cancer) 24.14 Chronic (cancer) 22.36 1 From the Tier II PRZM

- EXAMS

- Index Reservoir model. Highest surface water EDWC assumed a maximum application rate of 0.125 lbs ai/A, a maximum number of applications of 3 and an RTI of 7 days. For the premix label a maximum application rate of 0.09 lbs ai/A, a maximum of 4 applications and a 10 day RTI w ere evaluated but did not lead to the highest EDWC values. The scenario that gave the maximum acute and chronic (non cancer) EDWCs were aerial application to Florida Carrots. The scenario that gave the ma ximum cancer EDWC was aerial application to potatoes. 2 From the SCI

- GROW m odel assuming 3 applications of 0.125 lbs ai/A. Note: Since only a chronic dietary assessment was conducted, the value of 24.14 ppb is the value used to calculate exposure an d risk. 

### V. **DEEM -**  **FCIDTM Program and Consumption Information** The fluopicolide chronic dietary exposure and risk assessment was conducted using the DEEM

FCIDTM, 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/WWEI A). The se 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 publicl y available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgro ups, but for acute exposure assessment are retained as individual consumption events. Based on analy sis of the 2003

- 2008 WWEI A consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 y ear old), children 1

- 2, children 3

- 5, children 6

- 12, y outh 13

- 19, adults 20

- 49, females 13

- 49, and adults 50

- 99 y ears old. For chronic dietary

exposure asses sment, 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 daily consumption estimate for that food/food form to produce a residue intake estimate. The r esultingFluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 7 of 16 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 body weight/ day

and as a percent of the cPAD. This procedure is performed for each population subgroup. For acute exposure assessments, 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 assessmen t. 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. I n accordance with HED policy , per capita exposure and risk are reported for all tiers of anal ys is. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specificall y identified an d noted in the risk assessment. **V I**  **. Toxicological Information**  A summary

of the toxicological endpoints and doses chosen for the relevant exposure scenarios for human risk assessment are found below in Table 5
. The need for updating any of the toxicologi cal points of departure will be reassessed in addressing the new use registration that has been recently requested for fluopicolide. F or the purpose of this action, the prior toxicological endpoints and doses will therefore remain applicable for human ris k assessment. **Table 5**  **. Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Dietary Exposure Risk Assessment**  **. Exposure/**  **Scenario Point of** 

**Departure Uncertainty/FQP** 

**A Safety Factors RfD, PAD, Level** 

**of Concern Study and**  **Toxicological Effects** Ac ute Dietary (All Populations) An endpoint attributable to a single dose w as not identified from the available data.

Chronic Dietary (All Populations) Maternal

NOAEL=2 0 mg/kg/day

NOAEL =31.5 mg/kg/day (co

- critical study) UF A =10x

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

cRfD = 0.2 mg/kg/day cPAD = 0.2 mg/kg/day **Developm ental Toxicity Study in** 

**Rabbits** LOAEL (maternal) = 60 mg/kg/day based on death, abortions/premature deliveries, decreased food consumption and body weight gain. **C hronic Oncogenicity Study in Rats**  **(co -**  **critical study)** LOAEL = 109.4 mg/kg/day based on decreased body weight gain and increased thyroid w eight and increased incidence of thyroid lesions. Cancer (oral, dermal, inhalation) Classification: “ **Not Likely to be Carcinogenic to Hum**  **ans** ” 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 w ith lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity am ong members of the human p opulation (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference dose.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 8 of 16 **V I**  **I. Results/Discussion** As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The following summari z es the DEEM

- FCID (ver. 3.16 ) chronic exposure anal ys es. The c hronic aggregate (food + water) analy s i s w as performed using DEEM

- FCID estimating the dietary

exposure of the U.S. population and various population subgroups. The results reported below are for the general U.S. Population, all infants (<1 ye ar old), children 1

- 2, children 3

- 5, children 6

- 12, y outh 13

- 19, females 13

- 49, adults 20

- 49, and adults 50+ y ears. Results of Acute Dietary

Exposure Analy sis An acute d ietary

exposure and risk assessment was not conducted because an endpoint attributable to a single dose has not been identified for fluopicolide. Results of Chronic Dietary (Food and Drinking Water) Exposure Analy sis The established uses along with an inc reased tolerance on tuberous and corm subgroup 1C vegetables for fluopicolide will result in an estimated exposure to the U.S. Population which is equivalent to 7. 7 % of the cPAD. The most highly exposed subgroup is children 1

– 2 y ears of age with an esti mated exposure equivalent to 1 3 % of the cPAD. Results for all subpopulations are shown in the table below.

**Table 7. Chronic Dietary Exposure and Risk Estim ates for Fluopicolide.**  **Population Subgroup PAD**  **1 (m**  **g/kg/day) DEEM**  **- FCID** 

**Exposure (m**  **g/kg/day) %**  **PAD** U.S. Population

0.2 0.015 4 84 7. 7 All infants (< 1 yr) 0.01 08 81 5.4 Children 1

- 2 y

rs **0.0 25**  **122 1**  **3** Children 3

- 5 y

rs 0.0 23 460 1 2 Children 6

- 12 y

rs 0.0 14 866 7.4 Youth 13

- 19 y

rs 0.0 11 526 5. 8 Ad ults 20

- 49 y

rs 0.0 15 214 7.6 Ad ults 50

- 99 yrs 0.0 156 29 7. 8 Fem ales 13

- 49 y

rs 0.0 154 84 7.7 1 Chronic dietary analysis derived from a 0.2 mg/kg/day cPAD for the general population. 2 Highest exposures found for assessment is noted in bold. 

### Results of Cancer Dietary Exposure Anal ys is A cancer dietary

exposure and risk assessment was not conducted since fluopicolide is not likely to be carcinogenic to humans. **VII I**  **. Characterization of Inputs/Outputs**  This assessment is considered highl y conservative as it includes tolerance level res idues or maximum field trial residue levels for all crops, assumes 100% crop treated and uses empirical or default DEEM processing factors. To provide a comparison for reference, the chronic dietary results for the anal ys is of food exposures ( onl y ) are presented in attachment 3.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 9 of 16 **I X**  **. Conclusions**  The chronic dietary

risk from the established and newly proposed uses of fluopicolide is not of concern for the U.S. population and all population subgroups. This assessment is not likely to underestimate risk. **References** DP No. : D 407936 Subject: **Fluo picolide**  Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Tolerances on Rotational Corn. From: A. Kamel To: T. Kish and D. Schuler Dated: 0 4 / 08 / 20 1 3 MRI D No. : 48809201, 48842201 MRI D No. : 49177301 Allen, R. (2013) Fluopicolide: Proposal for a Revised Tolerance on Potato.

Laboratory

Project ID VP

- 38438. Unpublished study prepared by

Valent Technical Center. 19 p. DP No. : D417354 Sub ject: **Flu o**  **picolide.** Section 3 Registration of an Amended Tolerance on Tuberous and

Corm Subgroup 1C Vegetables and Potato Processed Waste for Fluopicolide. From: P. Savoia To: D. Schuler and T. Kish Dated: 0 4 / 22 /201 4 MRI D No. : 49177301 DP No. : D370762 Sub ject: **Fluopicolide.** Petitions to Establish Tolerances on Potatoes, S ugar Beets, Carrots,

Rotational Wheat, and Animal Commodities. Summary of Anal yt ical Chemistry

and Residue Data. From: D. S. Davis To: J. Whitehurst and T. Kish Dated: 0 8 / 19 / 201 0 MRI D No. : 47745901 and 47745902 DP No. : D 381051 and 381052 Subject: **2,6 -**  **Dichlorobenzamide (BAM).** Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment to Support New Section 3 Uses of Fluopicolide on Brassica Leafy Greens Subgroup 5B, Potatoes, Sugar Beets, and Carrots, and to Allow Ro tation to Wheat. From: D. S. Davis To: J. Whitehurst and T. Kish Dated: 0 9 / 09 /20 1 0 MRI D No. : NoneFluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 10 of 16 DP No. : D 381050 Subject: **Fluopicolide.** Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment to Support New Section 3 Uses on Brassica Leafy Greens Subgroup 5B, Potatoes, Sugar Beets, Carrots, and Rotational Wheat. From: D. S. Davis To: J. Whitehurst and T. Kish Dated: 08 / 19 / 2010 MRI D No. : None DP No. : D 370764 Sub ject: Tier II Drinking Water Exposure Assessment for Fluopicolide and its Major

Degradate, 2,6

- Dichlorbenzamide (BAM) for Uses on Potatoes, Carrots, Sugar Beets, and Brassica (Cole) Leafy Vegetables. From: R. Miller To: T. Kish and J. Whitehurst Dated: 0 7 / 20 /201 0 MRI D No. : None **X. List of Attachments**  1. Attachment 1: Chronic Dietary I nput File

. 2. Attachment 2 : Chronic Dietary Results (Food and Drinking Water) File

. 3

. Attachment 3 : Chronic Dietary Results (Food Only ) File.Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 11 of 16 **ATTACHMENT 1** 

Filename: G: \ Fluopicolide Dietary \ Residue Data Files \ FLUOPIC_Amended CG1C Tolerances_March 2014_ CHRONIC _Food and Water_W.R08 Chemical: fluopicolide 027412 RfD(Chronic): .2 mg/kg bw/day NOEL(Chronic): 20 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified : 03
- 13
- 2014/09:33:51 Program ver. 3.16, 03

- 08
- d Comment: PP#3F8191 Amended CG1C Tolerances (Food and Water)

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0401005000 4A Amaranth, leafy 25.000000 1.000 1 .000 0103015000 1CD Arrowroot, flour 0.540000 1.000 1.000 5F7016 0103015001 1CD Arrowroot, flour
- babyfood 0.540000 1.000 1.000 5F7016 0103017000 1CD Artichoke, Jerusalem 0.540000 1.000 1.000 5F7016 0401018000 4A Arugula 25.000000 1.000 1.000 0902021000 9B Balsam pear 0.500000 1.000 1.000 0101050000 1AB Beet, garden, roots 0.150000 1.000 1.000 PP#7E7

Full co mment: PP#7E7172 0101050001 1AB Beet, garden, roots
- babyfood 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0200051000 2 Beet, garden, tops 15.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0101052000 1A Beet, sugar 0.150000 1.000 1.000 new us

Full comment: new use 0101053000 1A Beet, sugar, molasses 0.150000 1.000 1.000 new us

Full comment: new use 0101053001 1A Beet, sugar, molasses
- babyfood 0.150000 1.000 1.000 new us

Full comment: new use 0101052001 1A Beet, sugar
- babyfood 0.150000 1.000 1.000 new us

Full comment: new use 0501061000 5A Broccoli 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0502063000 5B Broccoli raab 18.000000 1.000 1.000 9F7617 0501062000 5A Broccoli, Chinese 5.000000 1.000 1.000 PP#7E7

Ful l comment: PP#7E7172 0501061001 5A Broccoli
- babyfood 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0501064000 5A Brussels sprouts 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E71 72 0101067000 1AB Burdock 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0501069000 5A Cabbage 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0502070000 5B Cabbage, Chinese, bok choy 18.000000 1.000 1.000 9F7617 0501072000 5A Cabbage, Chinese, mustard 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0501071000 5A Cabbage, Chinese, napa 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0901075000 9A Cantaloupe 0.500000 1.000 1.000 0402076000 4B Cardoon 25.000000 1.000 1.000 0101078000 1AB Carrot 0.150000 1.000 1.000 new us

Full comment: new use 0101079000 1AB Carrot, juice 0.150000 1.000 1.000 new us

Full comment: new use 0101078001 1AB Carrot
- babyfood 0.150000 1.000 1.00 0 new us

Full comment: new use 0103082000 1CD Cassava 0.540000 1.000 1.000 5F7016 0103082001 1CD Cassava
- babyfood 0.540000 1.000 1.000 5F7016 0501083000 5A Cauliflower 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0101084000 1AB Celeriac 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0402085000 4B Celery 25.000000 1. 000 1.000 0402086000 4B Celery, juice 25.000000 1.000 1.000 0402085001 4B Celery
- babyfood 25.000000 1.000 1.000 0402087000 4B Celtuce 25.000000 1.000 1.000 0902088000 9 B Chayote, fruit 0.500000 1.000 1.000 0101100000 1AB Chicory, roots 0.150000 1.000 1.000 PP#7E7Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 12 of 16 Full comment: PP#7E7172 0200101000 2 Chicory, tops 15.000000 1.000 1.0 00 PP#7E7

Full comment: PP#7E7172 0902102000 9B Chinese waxgourd 0.500000 1.000 1.000 0302103000 3B Chive, fresh leaves 7.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0401104000 4A Chrysanthemum, garland 25.000000 1.000 1.000 0502117000 5B Collards 18.000000 1.000 1.000 9F7617 1500122000 15 Corn, field, bran 0.020000 1.000 1.000 2F8099 1500120000 15 Corn, field, flour 0.020000 1.000 1.000 2F8099 1500120001 15 Corn, field, flour
- babyfood 0.020000 1.000 1.000 2F8099 1500121000 15 Corn, field, meal 0.020000 1.000 1.000 2F8099 1500121001 15 Corn, field, meal
- babyfood 0.020000 1.000 1.000 2F8099 1500125000 15 Corn, field, oil 0.020000 2.100 1.000 2F8099 1500125001 15 Corn, field, oil
- babyfood 0.020000 2.100 1.000 2F8099 1500123000 15 Corn, field, starch 0.020000 1.000 1.000 2F8099 1500123001 15 Corn, field, starch
- babyfood 0.020000 1.000 1.000 2F8099 1500124000 15 Corn, field, syrup 0.020000 1.500 1.000 2F8099 1500124001 15 Corn, field, syrup
- babyfood 0.020000 1.500 1.000 2F8099 1500126000 15 Corn, pop 0.020000 1.000 1.000 2F8099 0401133000 4A Cress, garden 25.000000 1.000 1.000 0401134000 4A Cress, upland 25.000 000 1.000 1.000 0902135000 9B Cucumber 0.500000 1.000 1.000 0401138000 4A Dandelion, leaves 25.000000 1.000 1.000 0103139000 1CD Dasheen, corm 0.540000 1.000 1.000 5F701 6 0200140000 2 Dasheen, leaves 15.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0802148000 8BC Eggplant 1.600000 1.000 1.000 0401150000 4A Endive 25.00000 0 1.000 1.000 0402152000 4B Fennel, Florence 25.000000 1.000 1.000 0301165000 3A Garlic, bulb 7.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0301165001 3A Garlic, bulb
- babyfood 7.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0103166000 1CD Ginger 0.540000 1.000 1.000 5F7016 0103167000 1CD Ginger, dried 0.540000 1.000 1.000 5F7016 0103166001 1 CD Ginger
- babyfood 0.540000 1.000 1.000 5F7016 0101168000 1AB Ginseng, dried 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 1304175000 13D Grape 2.000000 1.000 1.000 1304176000 13D Grape, juice 2.000000 1.000 1.000 1304176001 13D Grape, juice
- babyfood 2.000000 1.000 1.000 9500177000 O Grape, le aves 2.000000 1.000 1.000 9500178000 O Grape, raisin 6.000000 1.000 1.000 1304179000 13D Grape, wine and sherry 2.000000 1.000 1.000 0901187000 9A Honeydew melon 0.500000 1.000 1.000 0101190000 1AB Horseradish 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0502194000 5B Kale 18.000000 1.000 1.000 9F7617 0501196000 5A Kohlrabi 5.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0302198000 3B Leek 7.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0401204000 4A Lettuce, head 25.000000 1.000 1.000 0401205000 4A Lettuce, leaf 25.000000 1.000 1.000 0502229000 5B Mustard greens 18.000000 1.000 1.000 9F7617 0802234000 8BC Okra 1.600000 1. 000 1.000 0301237000 3A Onion, bulb 7.000000 1.000 1.000 DEEM d

Full comment: DEEM default PF 0301238000 3A Onion, bulb, dried 7.000000 9.000 1.000 DEEM d

Full comment: DEEM defa ult PF 0301238001 3A Onion, bulb, dried
- babyfood 7.000000 9.000 1.000 DEEM d

Full comment: DEEM default PF 0301237001 3A Onion, bulb
- babyfood 7.000000 1.000 1.000 DEEM d

Full comment: DEEM default PF 0302239000 3B Onion, green 7.000000 1.000 1.000 0401248000 4A Parsley, leaves 25.000000 1.000 1.000 0101250000 1AB Parsley, turnip rooted 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0101251000 1AB Parsnip 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0101251001 1AB Parsnip
- babyfood 0.150000 1.000 1.000 PP#7E7

Full c omment: PP#7E7172Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 13 of 16 0802270000 8B Pepper, bell 1.600000 1.000 1.000 0802271000 8B Pepper, bell, dried 1.600000 1.000 1.000 0802271001 8B Pepper, bell, dried
- babyfood 1.600000 1.000 1.000 0802270 001 8B Pepper, bell
- babyfood 1.600000 1.000 1.000 0802272000 8BC Pepper, nonbell 1.600000 1.000 1.000 0802273000 8BC Pepper, nonbell, dried 1.600000 1.000 1.000 0802272001 8BC Pepper, nonbell
- babyfood 1.600000 1.000 1.000 0103296000 1C Potato, chips 0.540000 1.000 1.000 new us

Full comment: new use; empirical PF 0103297000 1C Potato, dry (granules/ flakes) 0.540000 1.000 1.000 new us

Full comment: new use; empirical PF 0103297001 1C Potato, dry (granules/ flakes)

- b 0.540000 1.000 1.000 new us

Full comment: new use; empirical PF 0103298000 1C Potato, flour 0.540000 1.000 1.000 new us

Full comment: new use; empirical PF 0103298001 1C Potato, flour
- babyfood 0.540000 1.000 1.000 new us

Full comment: new use; empirical PF 0103300000 1C Potato, tuber, w/o peel 0.540000 1.000 1.000 new us

Full comment: new use 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.540000 1.000 1.000 new us

Full comment: new use 0103299000 1C Potato, tuber, w/peel 0.540000 1.000 1.000 new us

Full comment: new use 0103299001 1C Potato, tuber, w/peel

- babyfood 0.540000 1.000 1.000 new us

Full comment: new use 0902308000 9B Pumpkin 0.500000 1.000 1.000 0902309000 9B Pumpkin, see d 0.500000 1.000 1.000 0401313000 4A Radicchio 25.000000 1.000 1.000 0101316000 1AB Radish, Oriental, roots 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0200317000 2 Radish, Oriental, tops 15.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0101314000 1AB Radish, roots 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0200315000 2 Radish, tops 15.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0502318000 5B Rape greens 18.000000 1.000 1.000 9F7617 0402322000 4B Rhubarb 25.000000 1.000 1.000 010132 7000 1AB Rutabaga 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0101331000 1AB Salsify, roots 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0200332000 2 Salsify, tops 15.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0302338500 3B Shallot, fresh leaves 7.000000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 0401355000 4A Spinach 25.000000 1.000 1.000 0401355001 4A Spinach
- babyfood 25.000000 1.000 1.000 0902356000 9B Squash, summer 0.500000 1.000 1.000 0902356001 9B Squash, summer
- babyfood 0.500000 1.000 1.000 0902357000 9B Squash, winter 0.500000 1.000 1.000 0902357001 9B Squash, winter
- babyfood 0.500000 1.000 1.000 0103366000 1CD Sweet potato 0.540000 1.000 1.000 5F7016 0103366001 1CD Sweet potato
- babyfood 0.540000 1.000 1.000 5F7016 0402367000 4B Swiss chard 25.000000 1.000 1.000 0103371000 1CD Tanier, corm 0.540000 1.000 1.000 5F7016 0801374000 8A Tomatillo 1.600000 1.000 1.000 0801375000 8A Tomato 1.600000 1.000 1.000 0801378000 8A Tomato, dried 1.600000 14.300 1.000 DEEM d

Full comment: DEEM d efault PF 0801378001 8A Tomato, dried
- babyfood 1.600000 14.300 1.000 DEEM d

Full comment: DEEM default PF 0801379000 8A Tomato, juice 1.600000 1.000 1.000 Empiri

Full comment: Empirical PF 0801376000 8A Tomato, paste 1.600000 1.000 1.000 Empiri

Full comment: Empirical PF 0801376001 8A Tomato, paste
- babyfood 1.600000 1.000 1.000 Empiri

Full comment: Empirical PF 0801377000 8A Tomato, puree 1.600000 1.000 1.000 Empiri

Full comment: Empirical PF 0801377001 8A Tomato, puree
- babyfood 1.600000 1.000 1.000 Empiri

Full comment: Empirical PF 0801375001 8A Tomato
- babyfood 1.600000 1.000 1.000Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 14 of 16 0103387000 1CD Turmeric 0.540000 1.000 1.000 5F7016 0502389000 5B Turnip, greens 15.000000 1.000 1.000 Crop G

Full comment: Crop Group 2 0101388000 1AB Turnip, roots 0.150000 1.000 1.000 PP#7E7

Full comment: PP#7E7172 8601000000 86A Water, direct, all sources 0.024140 1.000 1.000 8602000000 86B Water, indirect, all sources 0.0241 40 1.000 1.000 0901399000 9A Watermelon 0.500000 1.000 1.000 0901400000 9A Watermelon, juice 0.500000 1.000 1.000 1500404000 15 Wheat, bran 0.490000 1.000 1.000 rotati

Full comment: rotational crop use 1500402000 15 Wheat, flour 0.230000 1.000 1.000 rotati

Full comment: rotational crop use 1500402001 15 Wheat, flour
- babyfood 0.230000 1.000 1.000 rota ti

Full comment: rotational crop use 1500403000 15 Wheat, germ 0.240000 1.000 1.000 rotati

Full comment: rotational crop use 1500401000 15 Wheat, grain 0.230000 1.000 1.000 ro tati

Full comment: rotational crop use 1500401001 15 Wheat, grain
- babyfood 0.230000 1.000 1.000 rotati

Full comment: rotational crop use 0103407000 1CD Yam bean 0.540000 1.000 1.000 5F7016 0103406000 1CD Yam, true 0.540000 1.000 1.000 5F7016Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 15 of 16 **ATTACHMENT 2**  US EPA Ver. 3.16, 03
- 08
- d DEEM - FCID Chronic analysis for FLUOPICOLIDE 027412 NHANES 2003
- 2008 2
- day Residue file name: G: \ Fluopicolide Dietary \ Residue Data Files \ FLUOPIC_Amended CG1C Tolerances_March 2014_ CHRONIC _Food and Water_W.R08 Adjustment factor #2 NOT used. Analysis Date 03
- 13
- 2014 /09:38:58 Residue file dated: 03

- 13
- 2014/09:33:51 Reference dose (RfD, Chronic) = .2 mg/kg bw/day COMMENT 1: PP#3F8191 Amended CG1C Tolerances (Food and Water)

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

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

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

-------------------------------------- ------------- -------------- -- Total US Population 0.015484 7.7% Hispanic 0.014496 7.2% Non - Hisp
- White 0.015948 8.0% Non - Hisp
- Black 0.012939 6.5% Non - Hisp
- Other 0.017915 9.0% Nursing Infants 0.006674 3.3% Non - Nursing Infants 0.012759 6.4% Female 13+ PREG 0.014187 7.1% Children 1
- 6 0.023496 11.7% Children 7
- 12 0.013956 7.0% Male 13
- 19 0.010965 5.5% Female 13
- 19/NP 0.012091 6.0% Male 20+ 0.014183 7.1% Female 20+/NP 0.016524 8.3% Seniors 55+ 0.015507 7.8% All Infants 0.010881 5.4% Female 13
- 50 0.015467 7.7% Children 1
- 2 0.025122 12.6% Children 3
- 5 0.023460 11.7% Children 6
- 12 0.014866 7.4% Youth 13
- 19 0.011526 5.8% Adults 20
- 49 0.015214 7.6% Adults 50
- 99 0.015629 7.8% Female 13
- 49 0.015484 7.7%

------------ -------------------------------------------------------------------Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355



### Page 16 of 16 **ATTACHMENT 3**  US EPA Ver. 3.16, 03
- 08
- d DEEM - FCID Chronic analysis for FLUOPICOLIDE 027412 NHANES 2003
- 2008 2
- day Residue file name: G: \ Fluopicolide Dietary \ Residue Data Files \ FLUOPIC_Amended CG1C Tolerances_March 2014_ CHRONIC _Food Only_W.R08 Adjustment factor #2 NOT used. Analysis Date 03
- 13
- 2014/09:41:09 Residue file d ated: 03
- 13
- 2014/09:35:23 Reference dose (RfD, Chronic) = .2 mg/kg bw/day COMMENT 1: PP#3F8191 Amended CG1C Tolerances (Food Only)

=============================================================================== Total exposure by populat ion subgroup

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

----------------------------------- Populati on mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.014978 7.5% Hispanic 0.014014 7.0% Non - Hisp
- White 0.015428 7.7% Non - Hisp
- Black 0.012522 6.3% No n - Hisp
- Other 0.017333 8.7% Nursing Infants 0.006217 3.1% Non - Nursing Infants 0.011078 5.5% Female 13+ PREG 0.013711 6.9% Children 1
- 6 0.022849 11.4% Children 7
- 12 0.013535 6.8% Male 13
- 19 0.010617 5 .3% Female 13
- 19/NP 0.011701 5.9% Male 20+ 0.013712 6.9% Female 20+/NP 0.015993 8.0% Seniors 55+ 0.015018 7.5% All Infants 0.009577 4.8% Female 13
- 50 0.014964 7.5% Children 1
- 2 0.024393 12.2% Children 3
- 5 0.022845 11.4% Children 6
- 12 0.014423 7.2% Youth 13
- 19 0.011158 5.6% Adults 20
- 49 0.014710 7.4% Adults 50
- 99 0.015131 7.6% Female 13
- 49 0.014982 7.5%

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