`  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	19-MAR-2008

SUBJECT:	2,6-Dichlorobenzamide (BAM) as a Metabolite of Fluopicolide and Dichlobenil.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Actions for Fluopicolide on Root Vegetables (Subgroup 1A), Leaves of Root and Tuber Vegetables (Group 2), Bulb Vegetables (Group 3), and Head and Stem Brassica (Subgroup 5A)

					and

		Section 3 Registration Actions for Dichlobenil on Rhubarb, Caneberries (Subgroup 13-07A), Bushberries (Subgroup 13-07B) and Associated Berry Commodities.

PC Codes: 027402(BAM), 027401(Dichlobenil) and 027412(Fluopicolide)

Decision Number: 	373401

DP Number: 		349722

REVIEWERS:	Debra Rate, Ph.D., Biologist

				Sheila Piper, Chemist

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration, Minor Use and Emergency Response (RIMUER) Branch

Registration Division-RD (7505P)

THROUGH:	Thurston Morton, Chemist

Mohsen Sahafeyan, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division-HED (7509P)

and

			William Cutchin, Acting Senior Branch Scientist

			ARIA/RIMUERB/RD (7505P)

TO:		Felecia Fort, Risk Assessor

Reregistration Branch 1/ HED (7509P)

and

Janet Whitehurst/Tony Kish, RM Team #22

		Fungicide Branch/RD (7505P)

Executive Summary

Acute and chronic dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID™, Version 2.03, which use food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed on BAM to support Section 3 requests for use of parent fluopicolide on root vegetables, leaves of root and tuber vegetables, bulb vegetables, and head and stem Brassica and the Section 3 requests for use of parent dichlobenil on rhubarb, caneberries, bushberries and associated berry commodities.

BAM will be included in risk assessments for domestic crops.  This assessment is for residues of BAM from uses of fluopicolide and dichlobenil.  A separate assessment (D349721, S.Piper, 19-MAR-08) has been conducted for fluopicolide (parent) and a separate assessment (D341453, D.Rate, in process) is being conducted concurrently for dichlobenil (parent).  BAM is a metabolite and/or environmental degradate of both fluopicolide and dichlobenil.

Acute and Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

Conservative acute and chronic (food and drinking water) exposure assessments were conducted.  Maximum residues of BAM from fluopicolide field trials on root vegetables, leaves of root and tuber vegetables, bulb vegetables, and head and stem Brassica, and from dichlobenil field trials on food commodities with established/pending tolerances (40 CFR 180.231) were included in the assessments.  The assessments used 100% crop treated except for apples, blueberries, cherries, cranberries, peaches, pears, and raspberries.  No livestock tolerances are established or proposed for either fluopicolide or dichlobenil.  DEEM (version 7.81) default processing factors were used.

The drinking water residue level used in this dietary risk assessment is the estimate of residues of BAM from use of dichlobenil.  This assessment will use 56.2 ppb (from Screening Concentration in Ground Water-SCIGROW modeling of BAM residues from dichlobenil use on nutsedge) for the drinking water estimate for both the acute and chronic exposures.

The results of the acute dietary analysis for food and drinking water indicate that acute dietary risks do not exceed the Agency’s level of concern (<100% of the aPAD) for the U.S. population and all subgroups.  Combined dietary exposure from food and drinking water at the 99.9th percentile of exposure is estimated to be 0.011650 mg/kg/day for the overall U.S. population, equivalent to 12% of the acute Population Adjusted Dose (aPAD).  The population subgroup with the highest estimated acute dietary exposure is all infants (<1 year old) of 0.028470 mg/kg/day, equivalent to 28% of the aPAD.

Chronic dietary exposure estimates for food and drinking water are well below HED’s level of concern (<100% cPAD) for all population subgroups.  The dietary exposure is estimated at 0.001317 mg/kg/day for the general U.S. population (29% of the chronic Population Adjusted Dose (cPAD)) and 0.004170 mg/kg/day (93% of the cPAD) for infants (<1 year old), the population subgroup with the highest estimated chronic dietary exposure to BAM from fluopicolide and dichlobenil.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

BAM is formally unclassified with respect to cancer.  The parent fungicide fluopicolide is classified as “not likely to be carcinogenic to humans.”  The parent herbicide dichlobenil is classified as “Group C, possible human carcinogen” with the RfD approach utilized for quantification of human risk. The quantification of cancer risk using the RfD approach is identical to the assessment for chronic effects; no separate carcinogenic risk 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 which 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 point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, ARIA is concerned when estimated dietary risk exceeds 100% of the PAD.  ARIA is generally concerned when estimated cancer risk exceeds one in one million (i.e., the risk exceeds 3 x 10-6).  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:    HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/ Day -12/6061.pdf"  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 BAM was conducted by N.Dodd (21-NOV-07, D340366).

II.	Residue Information

BAM is a metabolite and/or environmental degradate of both fluopicolide and dichlobenil.  This risk assessment includes residues of BAM in food and drinking water from uses of both fluopicolide and dichlobenil.  A separate assessment (D349721, S.Piper, 19-MAR-08) has been conducted for fluopicolide (parent) and a separate assessment (D341453, D.Rate, in process) is being conducted concurrently for dichlobenil (parent).

Fluopicolide

Tolerances have been established (40 CFR §180.627) for residues of fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl] benzamide, range from 0.02 ppm on vegetable, tuberous and corm (except potato) to 6.0 ppm for use on grape raisins as an imported crops.  No livestock tolerances have been established.

Dichlobenil

Dichlobenil is registered as a granular (G) formulation (Casoron® 4G; EPA Reg. No. 400-168; date of issuance: 18-MAY-05) for use on apple, blueberry, cherry, filbert, grape, and pear at 6 lb ai/A/season and on blackberry, cranberry, and raspberry at 4 lb ai/A/season.  A registration for Casoron® 4G for use on rhubarb at 2 lb ai/A/season and translation of data to establish tolerances on berry commodities are pending (D315266, W.Cutchin, 22-FEB-06 and D349398, D.Rate, in process).

Tolerances are established (40 CFR §180.231) for the herbicide dichlobenil (2,6-dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzamide.  A tolerance for rhubarb and tolerances on berry commodities translated from the data reviewed for tolerances on blueberry, blackberry and raspberry are pending.  The revised RED (31-JUL-1996) recommended deletion of the stone fruit crop group tolerance which was not being supported by the petitioner and establishment of a separate tolerance on cherries.  However, the stone fruit crop group is included in this dietary exposure assessment since commodities containing BAM residues could be imported as long as the tolerance exists [as stated in the previous RED:  Kathryn Boyle, 31-JUL-1996:  Dichlobenil: The Revised HED Chapter of the Reregistration Eligibility Decision Document (RED), Case 0263, Chemical 027401, 027402 (BAM)].  No livestock tolerances are established for dichlobenil.  Since the potato use will not be registered at this time and some restrictions will be applied to rotational crops at this time, no livestock feed items are associated with this petition.

Residue Data used for Acute and Chronic Assessments:

Maximum residues of BAM from fluopicolide field trials were used on root vegetables, leaves of root and tuber vegetables, bulb vegetables, and head and stem Brassica and from dichlobenil field trials on rhubarb, caneberries, bushberries and associated berry commodities.  The assessments used 100% crop treated except for apples, blueberries, cherries, cranberries, peaches, pears, and raspberries (See attachment 6).  Tolerances for grape have been established for imported grapes; therefore, no percent crop treated was used.  No livestock tolerances are established or proposed for either fluopicolide or dichlobenil. DEEM (version 7.81) default processing factors were used.  A summary of the anticipated residues for the new uses are listed in Table 1 below.

Table 1. Residue Estimates Used in the BAM Dietary Analysis

RAC	Classification1	Data Source	No. of Samples	Acute

% CT2	Chronic

 % CT2	Processing Factors	Acute & Chronic (Maximum Residues ppm)

Amaranth, leafy	PB	MRID 46708540 (spinach)	14	100	100

0.188

Apple	NB/PB	MRID 42177102	15	2.5	1.0	8.0 dried

1.3 juice	RDF 1

0.271

Apricot5	NB/PB	MRID 42476102 (peach)	6	100	100	6.0 dried	0.04

Arrowroot, flour	NB	MRID 46708537	38	100	100

0.01

Artichoke	NB	MRID 46708537	38	100	100

0.01

Arugula	PB	MRID 46708540 (spinach)	14	100	100

0.188

Balsam, pear	NB	MRID 46708531 (cantaloupe)	18	100	100

0.01

Beet garden, roots	NB/PB	MRID 47021704 (radish roots)	12	100	100

0.01

Beet garden, tops	PB	MRID 47021704 (radish tops)	12	100	100

0.163

Blackberry	PB	MRID 42452803	3	100	100

0.01

Blueberry	PB	MRID 42304201	3	2.5	1.0

RDF 2

0.06

Boysenberry3	PB	MRID 42452803

(blackberry)	3	100	100

0.01

Broccoli	NB/PB	MRID 47021701	12	100	100

0.01

Brussels sprouts	PB	MRID 47021701 (cabbage)	14	100	100

0.017

Burdock	NB	MRID 4702170

(radish tops)	12	100	100

0.01

Cabbage	NB/PB	MRID 47021701	14	100	100

0.017

Cantaloupe	NB/PB	MRID 46708531	18	100	100

0.01

Cardoon	NB/PB	MRID 46708539

(celery)	12	100	100

0.041

Casaba	NB	MRID 46708531

(cantaloupe)	18	100	100

0.01

Cassava	NB/PB	MRID 47021704 (radish roots)	12	100	100

0.01

Cauliflower	NB/PB	MRID 47021701 (broccoli)	12	100	100

0.01

Celeriac	NB	MRID 47021704

(radish tops)	12	100	100

0.01

Celery	NB/PB	MRID 46708539	12	100	100

0.041

Chayote	NB	MRID 46708538

(squash)	12	100	100

0.01

Cherry	PB	MRID 42452804	2	2.5	1.0	1.5 juice	RDF 3

0.46

Chicory, roots	NB	MRID 47021704

(radish roots)	12	100	100

0.01

Chicory, tops	NB	MRID 47021704 (radish tops)	12	100	100

0.163

Chinese waxgourd	NB/PB	MRID 46708532

(cucumber)	12	100	100

0.01

Chive	B	MRID 47021703 (green onion)	6	100	100

0.014

Chrysanthemum, garland	PB	MRID 46708540 (spinach)	14	100	100

0.188

Cranberry	PB	MRID 42452801

100	45	1.1 juice	0.03

Cress	PB	MRID 46708540 (spinach)	14	100	100

0.188

Cucumber	NB/PB	MRID 46708532	12	100	100

0.01

Currant	PB	MRID 42304201 (blueberry)	3	2.5	1.0

0.06

Dandelion	PB	MRID 46708540 (spinach)	14	100	100

0.188

Dasheen corm	PB	MRID 47021704 (radish tops)	12	100	100

0.01

Dasheen leaves	PB	MRID 47021704 (radish roots)	12	100	100

0.163

Dewberry	PB	MRID 42452803 (blackberry)	3	100	100

0.01

Eggplant	NB	MRID 46708530 (pepper)	14	100	100

0.01

Elderberry4	PB	MRID 42304201

(blueberry)	3	100	100

0.06

Endive	PB	MRID 46708540 (spinach)	14	100	100

0.188

Fennel Florence	B	MRID 46708539 (celery)	12	100	100

0.041

Filbert6	PB	MRID 42476101	3	100	100

0.02

Garlic	NB/PB	MRID 47021703 (green onion)	6	100	100

0.014

Ginger	NB	MRID 47021704 (radish roots)	12	100	100

0.01

Ginseng	PB	MRID 47021704 (radish tops)	12	100	100

0.01

Gooseberry4	PB	MRID 42304201 (blueberry)	3	100	100

0.06

Grape	PB	MRID 42476103	12	100	100	4.3 raisin

1.2 juice	0.1

Honeydew Melon	NB	MRID 46708531 (cantaloupe)	18	100	100

0.01

Horseradish	NB/PB	MRID 47021704 (radish roots)	12	100	100

0.01

Huckleberry	PB	MRID 42304201 (blueberry)	3	2.5	1.0

0.06

Kohlrabi	NB	MRID 47021701 (cabbage)	14	100	100

0.017

Leek	NB	MRID 47021703 (green onion)	6	100	100

0.014

Lettuce, head	NB/PB	MRID 46708533	14	100	100

0.0132

Lettuce, leaf	NB/PB	MRID 46708534	14	100	100

0.038

Loganberry	PB	MRID 42452803 (blackberry)	3	100	100

0.01

Nectarine5	NB	MRID 42476102 (peach)	6	100	100

0.04

Okra	NB/PB	MRID 46708530 (pepper)	14	100	100

0.01

Onion, bulb	NB/PB/B	MRID 47021703	14	100	100	 9.0 dried	0.01

Onion, green	PB	MRID 47021703	6	100	100

0.014

Parsley, leaves	PB	MRID 46708540 (spinach)	14	100	100

0.188

Parsley, root	NB	MRID 47021704 (radish roots)	12	100	100

0.01

Parsnip	NB	MRID 47021704 (radish roots)	12	100	100

0.01

Peach	NB/PB	MRID 42476102	6	2.5	1.0	7.0 dried

1.5 juice	RDF 4

0.04

Pear	NB/PB	MRID 42177102 (apple)	15	2.5	1.0	6.25 dried	RDF 1

0.271

Pepper	NB/PB	MRID 46708530	14	100	100

0.01

Plum	NB/PB	MRID 42452804	2	100	100	5.0 prune dried

1.4 juice	0.46

Pumpkin	NB/PB	MRID 46708531 (cantaloupe)	18	100	100

0.01

Radicchio	NB	MRID 46708533 (lettuce)	14	100	100

0.0132

Radish, root	PB	MRID 47021704	12	100	100

0.01

Radish, tops	PB	MRID 47021704	12	100	100

0.163

Raspberry	PB	MRID 42452803 (blackberry)	3	5.0	5.0

RDF 5

70.01

Rhubarb	NB	MRID 46708539 (celery)	12	100	100

0.041

Rutabaga	NB/PB	MRID 47021704 (radish roots)	12	100	100

0.01

Salisfy, roots	NB	MRID 47021704 (radish roots)	12	100	100

0.01

Salisfy, tops	NB	MRID 47021704 (radish tops)	12	100	100

0.163

Shallot	NB	MRID 47021703 (green onion)	6	100	100

0.014

Spinach	PB	MRID 46708540	14	100	100

0.188

Squash	NB/PB	MRID 46708538	12	100	100

0.01

Sweet Potato	NB/PB	MRID 47021704 (radish roots)	12	100	100

0.01

Swiss Chard	NB	MRID 46708539 (celery)	12	100	100

0.041

Tomatillo	NB	MRID 46708536 (tomato)	24	100	100

0.01

Tomato	NB/PB	MRID 46708536	24	100	100	5.4 paste

3.3 puree

14.3 dried

1.5 juice	0.01

Turmeric	NB	MRID 47021704 (radish roots)	12	100	100

0.01

Turnip, roots	NB/PB	MRID 47021704 (radish roots)	12	100	100

0.01

Water	--

	--	--

0.0562

Watermelon	NB/PB	MRID 46708531 (cantaloupe)	18	100	100

0.01

Yam	NB	MRID 47021704 (radish roots)	12	100	100

0.01

1 B=Blended; PB=Partially Blended; NB=Not Blended

2 Percent crop treated data were provided by the Biological and Economic Analysis Division (DP Num: 342741, J. Alsadek, Ph.D., 22-AUG-2007).  “Percent of Crop Treated” values were used for the chronic assessment; “Maximum Percent of Crop Treated” values were used for the acute assessment.

3 Blackberry residue was translated to and used in the dietary analysis for caneberry, subgroup 13A and wild raspberry.

4 Blueberry residue was translated to and used in the dietary analysis for bushberry, Subgroup 13B.

5 Peach residue was translated to apricot and nectarine. [HED SOP 200.1:  Guidance for Translation of Field Trial Data from Representative Commodities in the Crop Group Regulation to Other Commodities in Each Crop Group/Subgroup, HED Standard Operating Procedure (12-SEP-2000)].

6 Filberts, the highest reported residue was doubled to 0.02 because of approximately 50% degradation on storage.

III. Drinking Water Data

As discussed below, the drinking water residue level used in this dietary risk assessment is the estimate of residues of BAM from use of dichlobenil.  This residue level was the highest, considering uses of dichlobenil, uses of fluopicolide, and uses of both fluopicolide and dichlobenil (on grapes and rhubarb, the only crops on which both pesticides will be registered).  This assessment will use 56.2 ppb (from SCIGROW modeling of BAM residues from dichlobenil use on nutsedge) for the drinking water estimate for both the acute and chronic exposures.

Dichlobenil

The BAM residues in drinking water from use of dichlobenil were provided by the Environmental Fate and Effects Division (EFED) in the following memoranda:  “Drinking Water Assessment for the BAM (2,6-Dichlorobenzamide) Degradate of Dichlobenil” (DP Num: 340773, J. Angier, Ph.D., 29-AUG-2007).  The sums of the reported values were incorporated directly into this dietary assessment.  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

This drinking water exposure assessment utilizes known physical/chemical characteristics of BAM, combined with estimated rates of formation of the degradate following dichlobenil application.  The OPP/EFED Tier 2 surface water model PRZM-EXAMS (Pesticide Root Zone Model - Exposure Analysis Modeling System) was used in this assessment.  Percent Cropped Area (PCA) corrections were applied for appropriate crops as well.  Currently registered and pending uses of dichlobenil were considered.  Dichlobenil use is currently registered for control of weeds in fruit and nut orchards (6 lbs ai/acre) and non-crop areas (12 lbs ai/acre), and for control of nutsedge (10 lbs ai/acre).  (Nutsedge usage was previously evaluated at 20 lbs ai/acre; the current label restricts this use to a maximum application rate of 10 lbs ai/acre.)  A new use on rhubarb (2 lbs ai/acre) is pending.  A screening assessment for the impact of BAM on potential groundwater drinking water sources, using the Tier 1 groundwater model SCIGROW, has also been conducted.

Each run was performed using fate and mobility parameters for BAM only.  To determine the equivalent amount of BAM degradate applied as a result of dichlobenil usage, the ‘applied’ BAM amounts were calculated by multiplying the maximum amount of BAM expected to form as a result of registered dichlobenil use (13.1%) by the (maximum allowed for each scenario) amounts of dichlobenil applied.  However, since BAM has a different molecular weight (190.3 g/mol) than parent dichlobenil (172 g/L), a further correction was applied.  Thus, in terms of total mass, BAM represents 14.5% of parent dichlobenil.  Rhubarb and orchard values have had PCA adjustments of 87% applied, while the nutsedge control and other non-crop uses have no PCA applied.

SURFACE WATER DRINKING WATER CONCENTRATIONS (ppb) FOR THE DEGRADATE BAM (RESULTING FROM DICHLOBENIL USE), MODELED USING PRZM-EXAMS

Scenario	Peak (acute)		1-in-10 Year Annual Mean		30 Year Overall Mean

FL turf (Nutsedge control):

20.9				8.61					3.97

CA lettuce (surrogate for Rhubarb):

		12.9				6.59					3.69

FL turf (non-crop weed control):

		25.5				10.5					4.84

OR apple (Orchards):

		6.13				3.63					0.896

Results for estimated (high-end) groundwater BAM concentrations from SCIGROW were obtained using the maximum proposed application rates (adjusted to reflect 14.5% of applied dichlobenil) and the available fate parameters for BAM.

GROUND WATER DRINKING WATER CONCENTRATIONS FOR BAM, RESULTING FROM PARENT DICHLOBENIL USE – MODELED USING SCIGROW

SciGrow output for Nutsedge control use = 56.2 ppb

SciGrow output for non-crop weed control use = 67.4 ppb

SciGrow output for Orchard use = 33.7 ppb

SciGrow output for Rhubarb use = 11.2 ppb

Since the weed control in non-crop areas is typically applied beneath a semi-protective layer such as concrete, vinyl liner, etc., it is not expected to contribute substantially to runoff or infiltration (as the covering will restrict contact with water).  Thus, for “non crop area weed control” only, the EECs are not truly representative of what would be expected under approved usage patterns (e.g., under concrete, asphalt, etc).

Based on modeling results, the estimated ground water drinking water concentration for BAM from use of dichlobenil is 56.2 ppb (based on SCIGROW modeling of dichlobenil use on nutsedge).  (The use for non-crop weed control is not expected to exceed the use for nutsedge control on an actual use basis.)  This BAM residue level is higher than estimated residues in surface water.

Fluopicolide

The BAM residues in drinking water from use of fluopicolide were provided by the EFED in the following memoranda: “Drinking Water Exposure Assessment for Fluopicolide Uses on Grapes, Vegetables, Potatoes, Sugar Beet, Onion, and Turf – Exposure of 2,6-Dichlorobenzamide (BAM) (DP Number 325804, J. Lin, 3-MAY-07).

This drinking water exposure memo addresses the human exposure of BAM through ingestion of drinking water from uses of fluopicolide on grapes, vegetables, sugar beet, onion and turf.  The drinking water exposure of fluopicolide itself has been addressed in an earlier drinking water exposure memo (07/MAR/2007).  Surface water concentrations were estimated using the Tier II model PRZM version 3.12 and EXAMS version 2.98.  Ground water concentrations were estimated using the Tier I SCI-GROW model.

Based on modeling results, the estimated surface water drinking water concentrations for BAM from uses of fluopicolide are:

4.26 ug /L for the 1-in-10 year annual peak concentration (acute)

1.53 ug /L for the 1-in-10 year annual mean concentration (non-cancer chronic) and

0.85 ug /L for the 30-year annual mean concentration (cancer chronic).

The 1-in-10 year annual peak (acute) was derived from modeling on Florida peppers.  The 1-in-10 year annual mean (non-cancer chronic) and the 30-year annual mean concentration (cancer chronic) were derived from modeling on California lettuce.  These values were highest among all modeling scenarios examined.

The SCI-GROW estimated ground water drinking water concentrations for BAM form uses of fluopicolide are not expected to exceed 4.19 μg/L, which was based on 2 applications of 0.054 lb ai/A per application.

Dichlobenil and Fluopicolide

Grapes and rhubarb (a leafy vegetable) are the only crops on which both dichlobenil and fluopicolide are to be registered.  The rates on grapes are 2 lb ai/A for dichlobenil and 0.375 lb ai/A for fluopicolide.  The rates on rhubarb are also 2 lb ai/A for dichlobenil and 0.375 lb ai/A for fluopicolide.  Since the rate for dichlobenil on nutsedge is much higher (10 lb ai/A), the dichlobenil use on nutsedge is expected to result in higher residues in drinking water.

IV.	DEEM-FCID™ Program and Consumption Information

BAM acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™, Version 2.03, which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (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 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, but for acute exposure assessment are retained as individual consumption events.  Based on analysis 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: 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+ years 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 daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the 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 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 all tiers of analysis.  However, for highly refined assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

BAM toxicity was reassessed (R. Mitkus, RAB1, updated 09-AUG-07) as follows:

Table 2.  Summary of Toxicological Doses and Endpoints for 2,6-Dichlorobenzamide (BAM) for Use in Dietary Exposure Assessments

Exposure Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (General population, including infants and children)	LOAEL = 100 mg/kg/day

	UFA = 10X

UFH = 10X

FQPA SF1,2 = 10X (includes UFL and UFDB)

	aRfD = aPAD = 0.1 mg/kg/day	Dose-range finding assay for in vivo mouse erythrocyte micronucleus assay LOAEL = 100 mg/kg/day based on lethargy after a single oral dose

Acute Dietary (Females 13-49 years of age)	NOAEL = 30 mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF1 = 10X

(includes UFDB)	aRfD = aPAD = 0.03 mg/kg/day	Developmental toxicity (rabbit) Offspring LOAEL = 90 mg/kg/day based on increased incidences of  late abortion and skeletal (bipartite interparietal bone) and visceral (postcaval lung lobe agenesis) anomalies

Chronic Dietary (All populations)	NOAEL = 4.5

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF1 = 10X

(includes UFDB)	cRfD = cPAD = 0.0045 mg/kg/day	Chronic toxicity (dog) LOAEL = 12.5 mg/kg/day based on decreased body weight and body weight gain

Cancer	Classification: Formally unclassified.  The parent herbicide dichlobenil is classified as “Group C, possible human carcinogen” with RfD approach utilized for quantification of human risk.  The parent fungicide fluopicolide is “not likely to be carcinogenic to humans.”

Abbreviations: UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies), FQPA SF = FQPA Safety Factor, UFL = use of a LOAEL to extrapolate a NOAEL, UFDB = to account for the absence of key data, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD = population adjusted dose, MOE = margin of exposure,

1 The FQPA SF has been retained in the form of a UFDB for the lack of neurotoxicity, including olfactory toxicity, data.

2 The FQPA SF has been retained in the form of a UFL and UFDB for the use of a LOAEL to extrapolate a NOAEL and for the lack of olfactory toxicity data.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, the Agency is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Tables 3 and 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  Cancer risk is determined for the general U.S. population only.

Results of Acute and Chronic Dietary (Food and Drinking Water) Exposure Analyses

The results of the acute dietary exposure analysis are reported in Table 3, below.  A conservative acute and chronic (food and drinking water) exposure assessments were conducted.  Maximum residues of BAM from fluopicolide field trials on root vegetables, leaves of root and tuber vegetables, bulb vegetables, and head and stem Brassica, and from dichlobenil field trials on food commodities with established/pending tolerances (40 CFR 180.231) were included in the assessments.  The assessments used 100% crop treated except for apples, blueberries, cherries, cranberries, peaches, pears, and raspberries.  No livestock tolerances are established or proposed for either fluopicolide or dichlobenil.  DEEM default processing factors were used.

The drinking water residue level used in this dietary risk assessment is the estimate of residues of BAM from use of dichlobenil.  This assessment will use 56.2 ppb (from SCIGROW modeling of BAM residues from dichlobenil use on nutsedge) for the drinking water estimate for both the acute and chronic exposures.

The results of the acute dietary analysis for food and drinking water indicate that acute dietary risks do not exceed the Agency’s level of concern (<100% of the aPAD) for the U.S. population and all subgroups.  Combined dietary from food and drinking water at the 99.9th percentile of exposure is estimated to be 0.011650 mg/kg/day for the overall U.S. population, equivalent to 12% of the aPAD.  The population subgroup with the highest estimated acute dietary exposure are all infants (<1 year old) of 0.028470 mg/kg/day, equivalent to 28% of the aPAD.

Table 3.  Results of Acute Dietary for Food and Water using DEEM-FCID

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile 99.9th Percentile

Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% aPAD

General U.S. Population	0.1	0.003294	3	0.005997	6	0.011650	12

All Infants (< 1 year old)

0.011506	12	0.016406	16	0.028470	28

Children 1-2 years old

0.005949	6	0.009911	10	0.017320	17

Children 3-5 years old

0.005021	5	0.007521	8	0.014934	15

Children 6-12 years old

0.003314	3	0.005349	5	0.008285	8

Youth 13-19 years old

0.002576	3	0.004146	4	0.007207	7

Adults 20-49 years old

0.002886	3	0.004726	5	0.008394	8

Adults 50+ years old

0.002726	3	0.003983	4	0.006591	7

Females 13-49 years old	0.03	0.002926	10	0.004720	16	0.008495	28

As shown in Table 4, chronic dietary exposure estimates for food and drinking water are well below HED’s level of concern (<100% cPAD) for all population subgroups.  The dietary exposure is estimated at 0.001317 mg/kg/day for the general U.S. population (29% of the cPAD) and 0.004170 mg/kg/day (93% of the cPAD) for infants (<1 year old), the population subgroup with the highest estimated chronic dietary exposure to BAM from fluopicolide and dichlobenil.

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

Population Subgroup	Acute Dietary

(99.9th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	0.011650	11	0.001317	29	*	*

All Infants (< 1 year old)	0.028470	28	0.004170	93	N/A	N/A

Children 1-2 years old	0.017320	17	0.002284	51

Children 3-5 years old	0.014934	12	0.001985	44

Children 6-12 years old	0.008285	7	0.001297	29

Youth 13-19 years old	0.007207	7	0.000930	21

Adults 20-49 years old	0.008394	8	0.001196	27

Adults 50+ years old	0.006591	7	0.001288	29

Females 13-49 years old	0.008495	28	0.001196	27

* Classification: BAM is formally unclassified.  The parent herbicide dichlobenil is classified as “Group C, possible human carcinogen” with RfD approach utilized for quantification of human risk.  The quantification of cancer risk using the RfD approach is identical to the assessment for chronic effects; no separate carcinogenic risk assessment is necessary.   The parent fungicide fluopicolide is “not likely to be carcinogenic to humans.”

VII.	Characterization of Inputs/Outputs

Conservative acute and chronic (food and drinking water) exposure assessments were conducted.  Maximum residues of BAM from fluopicolide field trials on imported grapes and from dichlobenil field trials on food commodities with established/pending tolerances (40 CFR 180.231) were included in the assessment.  The assessments used 100% crop treated except for apples, blueberries, cherries, cranberries, peaches, pears, and raspberries.  No livestock tolerances are established or proposed for either fluopicolide or dichlobenil.  DEEM default processing factors were used.  Although not needed at this time, HED could refine the exposure and risk assessments with the following information:  1) additional projected market share/percent crop treated data; 2) anticipated residue data; and 3) processing studies.

VIII.	Conclusions

The results of the acute dietary analysis for food and drinking water indicate that acute dietary risks do not exceed the Agency’s level of concern (<100% of the aPAD) for the U.S. population and all subgroups.  Combined dietary from food and drinking water at the 99.9th percentile of exposure is estimated to be 0.011650 mg/kg/day for the overall U.S. population, equivalent to 12% of the aPAD.  The population subgroup with the highest estimated acute dietary exposure are all infants (<1 year old) of 0.028470 mg/kg/day, equivalent to 28% of the aPAD.

The results of the chronic dietary exposure estimates for food and drinking water are well below HED’s level of concern (<100% cPAD) for all population subgroups.  The dietary exposure is estimated at 0.001317 mg/kg/day for the general U.S. population (29% of the cPAD) and 0.004170 mg/kg/day (93% of the cPAD) for infants (<1 year old), the population subgroup with the highest estimated chronic dietary exposure to BAM from fluopicolide and dichlobenil.

IX.		List of Attachments

1.  Residue Distribution Files for the Acute Analyses

2.  Acute Food Plus Water Residue Input File

3.  Acute Food Plus Water Results File

4.  Chronic Food Plus Water Residue Input File

5.  Chronic Food Plus Water Results File

6.  Screening Level Estimates of Agricultural Uses of Dichlobenil

Attachment 1:  Residue Distribution Files for the Acute Analyses

RDF #1

'Apple, maximum res FT data; 2.5%CT

TOTALZ=39

TOTALNZ=1

0.271	RDF #2

'Blueberry, maximum res FT data; 2.5%CT

TOTALZ=39

TOTALNZ=1

0.06

RDF#3

'Cherry, maximum res FT data; 2.5%CT

TOTALZ=39

TOTALNZ=1

0.46	RDF#4

'Peach, maximum res FT data; 2.5%CT

TOTALZ=39

TOTALNZ=1

0.04

RDF#5

'Raspberry, maximum res FT data; 5%CT

TOTALZ=19

TOTALNZ=1

0.01

	Attachment 2:  Acute Food plus Water Residue Input File

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for 2,6-DICHLOROBENZAMIDE (BAM)

Residue file name: C:\DEEMFCID\BAM\BAM_domestic_acutePP7E7172R98.R98

Analysis Date 03-18-2008             Residue file dated: 03-18-2008/11:39:42/8

Reference dose (aRfD) = 0.1 mg/kg bw/day

Comment: New uses from PP#7E7172 + dichlobenil

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

RDL indices and parameters for Monte Carlo Analysis:

Index Dist Parameter #1           Param #2    Param #3    Comment

  #   Code

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

  1    6   apple.RDF

  2    6   blueberry.RDF

  3    6   Cherry.RDF

  4    6   Peach.RDF

  5    6   Raspberry.RDF

  EPA    Crop Food Name                         Def Res     Adj.Factors  RDL  Comment

  Code    Grp                                    (ppm)       #1     #2   Pntr

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

04010050 4A   Amaranth, leafy                    0.188000   1.000  1.000

11000070 11   Apple, fruit with peel             0.271000   1.000  1.000   1

11000080 11   Apple, peeled fruit                0.271000   1.000  1.000   1

11000081 11   Apple, peeled fruit-babyfood       0.271000   1.000  1.000   1

11000090 11   Apple, dried                       0.271000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.271000   8.000  1.000

11000100 11   Apple, juice                       0.271000   1.300  1.000   1

11000101 11   Apple, juice-babyfood              0.271000   1.300  1.000   1

11000110 11   Apple, sauce                       0.271000   1.000  1.000   1

11000111 11   Apple, sauce-babyfood              0.271000   1.000  1.000   1

12000120 12   Apricot                            0.040000   1.000  1.000

12000121 12   Apricot-babyfood                   0.040000   1.000  1.000

12000130 12   Apricot, dried                     0.040000   6.000  1.000

12000140 12   Apricot, juice                     0.040000   1.000  1.000

12000141 12   Apricot, juice-babyfood            0.040000   1.000  1.000

01030150 1CD  Arrowroot, flour                   0.010000   1.000  1.000

01030151 1CD  Arrowroot, flour-babyfood          0.010000   1.000  1.000

01030170 1CD  Artichoke, Jerusalem               0.010000   1.000  1.000

04010180 4A   Arugula                            0.188000   1.000  1.000

09020210 9B   Balsam pear                        0.010000   1.000  1.000

01010500 1AB  Beet, garden, roots                0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01010501 1AB  Beet, garden, roots-babyfood       0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

02000510 2    Beet, garden, tops                 0.163000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

13010550 13A  Blackberry                         0.010000   1.000  1.000

13010560 13A  Blackberry, juice                  0.010000   1.000  1.000

13010561 13A  Blackberry, juice-babyfood         0.010000   1.000  1.000

13020570 13B  Blueberry                          0.060000   1.000  1.000   2

13020571 13B  Blueberry-babyfood                 0.060000   1.000  1.000   2

13010580 13A  Boysenberry                        0.010000   1.000  1.000      dichlo

    Full comment: dichlobenil

05010610 5A   Broccoli                           0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

05010611 5A   Broccoli-babyfood                  0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

05010620 5A   Broccoli, Chinese                  0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

05010640 5A   Brussels sprouts                   0.017000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01010670 1AB  Burdock                            0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

05010690 5A   Cabbage                            0.017000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

05010710 5A   Cabbage, Chinese, napa             0.017000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

05010720 5A   Cabbage, Chinese, mustard          0.017000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

09010750 9A   Cantaloupe                         0.010000   1.000  1.000

04020760 4B   Cardoon                            0.041000   1.000  1.000

09010800 9A   Casaba                             0.010000   1.000  1.000

01030820 1CD  Cassava                            0.010000   1.000  1.000

01030821 1CD  Cassava-babyfood                   0.010000   1.000  1.000

05010830 5A   Cauliflower                        0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01010840 1AB  Celeriac                           0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

04020850 4B   Celery                             0.041000   1.000  1.000

04020851 4B   Celery-babyfood                    0.041000   1.000  1.000

04020860 4B   Celery, juice                      0.041000   1.000  1.000

04020870 4B   Celtuce                            0.041000   1.000  1.000

09020880 9B   Chayote, fruit                     0.010000   1.000  1.000

12000900 12   Cherry                             0.460000   1.000  1.000   3

12000901 12   Cherry-babyfood                    0.460000   1.000  1.000   3

12000910 12   Cherry, juice                      0.460000   1.500  1.000   3

12000911 12   Cherry, juice-babyfood             0.460000   1.500  1.000   3

01011000 1AB  Chicory, roots                     0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

02001010 2    Chicory, tops                      0.163000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

09021020 9B   Chinese waxgourd                   0.010000   1.000  1.000

19011030 19A  Chive                              0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

04011040 4A   Chrysanthemum, garland             0.188000   1.000  1.000

04011330 4A   Cress, garden                      0.188000   1.000  1.000

04011340 4A   Cress, upland                      0.188000   1.000  1.000

09021350 9B   Cucumber                           0.010000   1.000  1.000

13021360 13B  Currant                            0.060000   1.000  1.000      dichlo

    Full comment: dichlobenil

13021370 13B  Currant, dried                     0.060000   1.000  1.000      dichlo

    Full comment: dichlobenil

04011380 4A   Dandelion, leaves                  0.188000   1.000  1.000

01031390 1CD  Dasheen, corm                      0.010000   1.000  1.000

02001400 2    Dasheen, leaves                    0.163000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

13011420 13A  Dewberry                           0.010000   1.000  1.000      dichlo

    Full comment: dichlobenil

08001480 8    Eggplant                           0.010000   1.000  1.000

13021490 13B  Elderberry                         0.060000   1.000  1.000      dichlo

    Full comment: dichlobenil

04011500 4A   Endive                             0.188000   1.000  1.000

04021520 4B   Fennel, Florence                   0.041000   1.000  1.000

14001550 14   Filbert                            0.020000   1.000  1.000

14001560 14   Filbert, oil                       0.020000   1.000  1.000

03001640 3    Garlic                             0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

03001650 3    Garlic, dried                      0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

03001651 3    Garlic, dried-babyfood             0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01031660 1CD  Ginger                             0.010000   1.000  1.000

01031661 1CD  Ginger-babyfood                    0.010000   1.000  1.000

01031670 1CD  Ginger, dried                      0.010000   1.000  1.000

01011680 1AB  Ginseng, dried                     0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

13021740 13B  Gooseberry                         0.060000   1.000  1.000      dichlo

    Full comment: dichlobenil

95001750 O    Grape                              0.100000   1.000  1.000

95001760 O    Grape, juice                       0.100000   1.200  1.000

95001761 O    Grape, juice-babyfood              0.100000   1.200  1.000

95001770 O    Grape, leaves                      0.100000   1.000  1.000

95001780 O    Grape, raisin                      0.100000   4.300  1.000

95001790 O    Grape, wine and sherry             0.100000   1.200  1.000

09011870 9A   Honeydew melon                     0.010000   1.000  1.000

01011900 1AB  Horseradish                        0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

13021910 13B  Huckleberry                        0.060000   1.000  1.000      dichlo

    Full comment: dichlobenil

05011960 5A   Kohlrabi                           0.017000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

03001980 3    Leek                               0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

04012040 4A   Lettuce, head                      0.013200   1.000  1.000

04012050 4A   Lettuce, leaf                      0.038000   1.000  1.000

13012080 13A  Loganberry                         0.010000   1.000  1.000      dichlo

    Full comment: dichlobenil

12002300 12   Nectarine                          0.040000   1.000  1.000

08002340 8    Okra                               0.010000   1.000  1.000

03002370 3    Onion, dry bulb                    0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

03002371 3    Onion, dry bulb-babyfood           0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

03002380 3    Onion, dry bulb, dried             0.010000   9.000  1.000      PP#7E7

    Full comment: PP#7E7172

03002381 3    Onion, dry bulb, dried-babyfood    0.010000   9.000  1.000      PP#7E7

    Full comment: PP#7E7172

03002390 3    Onion, green                       0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

04012480 4A   Parsley, leaves                    0.188000   1.000  1.000

01012500 1AB  Parsley, turnip rooted             0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01012510 1AB  Parsnip                            0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01012511 1AB  Parsnip-babyfood                   0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

12002600 12   Peach                              0.040000   1.000  1.000   4

12002601 12   Peach-babyfood                     0.040000   1.000  1.000   4

12002610 12   Peach, dried                       0.040000   7.000  1.000   4

12002611 12   Peach, dried-babyfood              0.040000   7.000  1.000   4

12002620 12   Peach, juice                       0.040000   1.500  1.000   4

12002621 12   Peach, juice-babyfood              0.040000   1.500  1.000   4

11002660 11   Pear                               0.271000   1.000  1.000   1

11002661 11   Pear-babyfood                      0.271000   1.000  1.000   1

11002670 11   Pear, dried                        0.271000   6.250  1.000   1

11002680 11   Pear, juice                        0.271000   1.000  1.000   1

11002681 11   Pear, juice-babyfood               0.271000   1.000  1.000   1

08002700 8    Pepper, bell                       0.010000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.010000   1.000  1.000

08002710 8    Pepper, bell, dried                0.010000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.010000   1.000  1.000

08002720 8    Pepper, nonbell                    0.010000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.010000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.010000   1.000  1.000

12002850 12   Plum                               0.460000   1.000  1.000

12002851 12   Plum-babyfood                      0.460000   1.000  1.000

12002860 12   Plum, prune, fresh                 0.460000   1.000  1.000

12002861 12   Plum, prune, fresh-babyfood        0.460000   1.000  1.000

12002870 12   Plum, prune, dried                 0.460000   5.000  1.000

12002871 12   Plum, prune, dried-babyfood        0.460000   5.000  1.000

12002880 12   Plum, prune, juice                 0.460000   1.400  1.000

12002881 12   Plum, prune, juice-babyfood        0.460000   1.400  1.000

09023080 9B   Pumpkin                            0.010000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.010000   1.000  1.000

04013130 4A   Radicchio                          0.013200   1.000  1.000

01013140 1AB  Radish, roots                      0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

02003150 2    Radish, tops                       0.163000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01013160 1AB  Radish, Oriental, roots            0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

02003170 2    Radish, Oriental, tops             0.163000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

13013200 13A  Raspberry                          0.010000   1.000  1.000   5  dichlo

    Full comment: dichlobenil

13013201 13A  Raspberry-babyfood                 0.010000   1.000  1.000   5

13013210 13A  Raspberry, juice                   0.010000   1.000  1.000   5

13013211 13A  Raspberry, juice-babyfood          0.010000   1.000  1.000   5

04023220 4B   Rhubarb                            0.041000   1.000  1.000

01013270 1AB  Rutabaga                           0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

01013310 1AB  Salsify, roots                     0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

02003320 2    Salsify, tops                      0.163000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

03003380 3    Shallot                            0.014000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

04013550 4A   Spinach                            0.188000   1.000  1.000

04013551 4A   Spinach-babyfood                   0.188000   1.000  1.000

09023560 9B   Squash, summer                     0.010000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.010000   1.000  1.000

09023570 9B   Squash, winter                     0.010000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.010000   1.000  1.000

01033660 1CD  Sweet potato                       0.010000   1.000  1.000

01033661 1CD  Sweet potato-babyfood              0.010000   1.000  1.000

04023670 4B   Swiss chard                        0.041000   1.000  1.000

01033710 1CD  Tanier, corm                       0.010000   1.000  1.000

08003740 8    Tomatillo                          0.010000   1.000  1.000

08003750 8    Tomato                             0.010000   1.000  1.000

08003751 8    Tomato-babyfood                    0.010000   1.000  1.000

08003760 8    Tomato, paste                      0.010000   5.400  1.000

08003761 8    Tomato, paste-babyfood             0.010000   5.400  1.000

08003770 8    Tomato, puree                      0.010000   3.300  1.000

08003771 8    Tomato, puree-babyfood             0.010000   3.300  1.000

08003780 8    Tomato, dried                      0.010000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.010000  14.300  1.000

08003790 8    Tomato, juice                      0.010000   1.500  1.000

01033870 1CD  Turmeric                           0.010000   1.000  1.000

01013880 1AB  Turnip, roots                      0.010000   1.000  1.000      PP#7E7

    Full comment: PP#7E7172

86010000 O    Water, direct, all sources         0.056200   1.000  1.000

86020000 O    Water, indirect, all sources       0.056200   1.000  1.000

09013990 9A   Watermelon                         0.010000   1.000  1.000

09014000 9A   Watermelon, juice                  0.010000   1.000  1.000

01034060 1CD  Yam, true                          0.010000   1.000  1.000

01034070 1CD  Yam bean                           0.010000   1.000  1.000

Attachment 3:  Acute Food Plus Water Results File

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for 2,6-DICHLOROBENZAMIDE (BAM)         (1994-98 data)

Residue file: BAM_domestic_acutePP7E7172R98.R98       Adjustment factor #2 used.

Analysis Date: 03-18-2008/12:05:12    Residue file dated: 03-18-2008/11:39:42/8

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "New uses from PP#7E7172 + dichlobenil"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aPAD    Exposure   % aPAD    Exposure   % aPAD

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

U.S. Population:

                    0.003294     3.29    0.005997     6.00    0.011650    11.65

All infants:

                    0.011506    11.51    0.016406    16.41    0.028470    28.47

Children 1-2 yrs:

                    0.005949     5.95    0.009911     9.91    0.017320    17.32

Children 3-5 yrs:

                    0.005021     5.02    0.007521     7.52    0.014934    14.93

Children 6-12 yrs:

                    0.003314     3.31    0.005349     5.35    0.008285     8.28

Youth 13-19 yrs:

                    0.002576     2.58    0.004146     4.15    0.007207     7.21

Adults 20-49 yrs:

                    0.002886     2.89    0.004726     4.73    0.008394     8.39

Adults 50+ yrs:

                    0.002726     2.73    0.003983     3.98    0.006591     6.59

Females 13-49 yrs:

                    0.002926     9.75    0.004720    15.73    0.008495    28.32

Attachment 4:  Chronic Food Plus Water Residue Input File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for 2,6-DICHLOROBENZAMIDE (BAM)        1994-98 data

Residue file: C:\DEEMFCID\BAM\BAM_domestic_chronicPP7E7271.R98 Adjust. #2 used

Analysis Date 03-18-2008             Residue file dated: 03-18-2008/11:51:13/8

Reference dose (RfD) = 0.0045 mg/kg bw/day

Comment:New uses from PP#7E7172 + dichlobenil berries

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

04010050 4A   Amaranth, leafy                    0.188000   1.000      1.000

11000070 11   Apple, fruit with peel             0.271000   1.000      0.010

11000080 11   Apple, peeled fruit                0.271000   1.000      0.010

11000081 11   Apple, peeled fruit-babyfood       0.271000   1.000      0.010

11000090 11   Apple, dried                       0.271000   8.000      0.010

11000091 11   Apple, dried-babyfood              0.271000   8.000      0.010

11000100 11   Apple, juice                       0.271000   1.300      0.010

11000101 11   Apple, juice-babyfood              0.271000   1.300      0.010

11000110 11   Apple, sauce                       0.271000   1.000      0.010

11000111 11   Apple, sauce-babyfood              0.271000   1.000      0.010

12000120 12   Apricot                            0.040000   1.000      1.000

12000121 12   Apricot-babyfood                   0.040000   1.000      1.000

12000130 12   Apricot, dried                     0.040000   6.000      1.000

12000140 12   Apricot, juice                     0.040000   1.000      1.000

12000141 12   Apricot, juice-babyfood            0.040000   1.000      1.000

01030150 1CD  Arrowroot, flour                   0.010000   1.000      1.000

01030151 1CD  Arrowroot, flour-babyfood          0.010000   1.000      1.000

01030170 1CD  Artichoke, Jerusalem               0.010000   1.000      1.000

04010180 4A   Arugula                            0.188000   1.000      1.000

09020210 9B   Balsam pear                        0.010000   1.000      1.000

01010500 1AB  Beet, garden, roots                0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01010501 1AB  Beet, garden, roots-babyfood       0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

02000510 2    Beet, garden, tops                 0.163000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

13010550 13A  Blackberry                         0.010000   1.000      1.000

13010560 13A  Blackberry, juice                  0.010000   1.000      1.000

13010561 13A  Blackberry, juice-babyfood         0.010000   1.000      1.000

13020570 13B  Blueberry                          0.060000   1.000      0.010

13020571 13B  Blueberry-babyfood                 0.060000   1.000      0.010

13010580 13A  Boysenberry                        0.010000   1.000      1.000   dichlo

  Full comment: dichlobenil

05010610 5A   Broccoli                           0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

05010611 5A   Broccoli-babyfood                  0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

05010620 5A   Broccoli, Chinese                  0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

05010640 5A   Brussels sprouts                   0.017000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01010670 1AB  Burdock                            0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

05010690 5A   Cabbage                            0.017000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

05010710 5A   Cabbage, Chinese, napa             0.017000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

05010720 5A   Cabbage, Chinese, mustard          0.017000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

09010750 9A   Cantaloupe                         0.010000   1.000      1.000

04020760 4B   Cardoon                            0.041000   1.000      1.000

09010800 9A   Casaba                             0.010000   1.000      1.000

01030820 1CD  Cassava                            0.010000   1.000      1.000

01030821 1CD  Cassava-babyfood                   0.010000   1.000      1.000

05010830 5A   Cauliflower                        0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01010840 1AB  Celeriac                           0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

04020850 4B   Celery                             0.041000   1.000      1.000

04020851 4B   Celery-babyfood                    0.041000   1.000      1.000

04020860 4B   Celery, juice                      0.041000   1.000      1.000

04020870 4B   Celtuce                            0.041000   1.000      1.000

09020880 9B   Chayote, fruit                     0.010000   1.000      1.000

12000900 12   Cherry                             0.460000   1.000      0.010

12000901 12   Cherry-babyfood                    0.460000   1.000      0.010

12000910 12   Cherry, juice                      0.460000   1.500      0.010

12000911 12   Cherry, juice-babyfood             0.460000   1.500      0.010

01011000 1AB  Chicory, roots                     0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

02001010 2    Chicory, tops                      0.163000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

09021020 9B   Chinese waxgourd                   0.010000   1.000      1.000

19011030 19A  Chive                              0.014000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

04011040 4A   Chrysanthemum, garland             0.188000   1.000      1.000

04011330 4A   Cress, garden                      0.188000   1.000      1.000

04011340 4A   Cress, upland                      0.188000   1.000      1.000

09021350 9B   Cucumber                           0.010000   1.000      1.000

13021360 13B  Currant                            0.060000   1.000      1.000   dichlo

  Full comment: dichlobenil

13021370 13B  Currant, dried                     0.060000   1.000      1.000   dichlo

  Full comment: dichlobenil

04011380 4A   Dandelion, leaves                  0.188000   1.000      1.000

01031390 1CD  Dasheen, corm                      0.010000   1.000      1.000

02001400 2    Dasheen, leaves                    0.163000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

13011420 13A  Dewberry                           0.010000   1.000      1.000   dichlo

  Full comment: dichlobenil

08001480 8    Eggplant                           0.010000   1.000      1.000

13021490 13B  Elderberry                         0.060000   1.000      1.000   dichlo

  Full comment: dichlobenil

04011500 4A   Endive                             0.188000   1.000      1.000

04021520 4B   Fennel, Florence                   0.041000   1.000      1.000

14001550 14   Filbert                            0.020000   1.000      1.000

14001560 14   Filbert, oil                       0.020000   1.000      1.000

03001640 3    Garlic                             0.014000   1.000      1.000   PP#737

  Full comment: PP#737172

03001650 3    Garlic, dried                      0.014000   1.000      1.000   PP#737

  Full comment: PP#737172

03001651 3    Garlic, dried-babyfood             0.014000   1.000      1.000   PP#737

  Full comment: PP#737172

01031660 1CD  Ginger                             0.010000   1.000      1.000

01031661 1CD  Ginger-babyfood                    0.010000   1.000      1.000

01031670 1CD  Ginger, dried                      0.010000   1.000      1.000

01011680 1AB  Ginseng, dried                     0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

13021740 13B  Gooseberry                         0.060000   1.000      1.000   dichlo

  Full comment: dichlobenil

95001750 O    Grape                              0.100000   1.000      1.000

95001760 O    Grape, juice                       0.100000   1.200      1.000

95001761 O    Grape, juice-babyfood              0.100000   1.200      1.000

95001770 O    Grape, leaves                      0.100000   1.000      1.000

95001780 O    Grape, raisin                      0.100000   4.300      1.000

95001790 O    Grape, wine and sherry             0.100000   1.200      1.000

09011870 9A   Honeydew melon                     0.010000   1.000      1.000

01011900 1AB  Horseradish                        0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

13021910 13B  Huckleberry                        0.060000   1.000      1.000   dichlo

  Full comment: dichlobenil

05011960 5A   Kohlrabi                           0.017000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

03001980 3    Leek                               0.014000   1.000      1.000   PP#737

  Full comment: PP#737172

04012040 4A   Lettuce, head                      0.013200   1.000      1.000

04012050 4A   Lettuce, leaf                      0.038000   1.000      1.000

13012080 13A  Loganberry                         0.010000   1.000      1.000   dichlo

  Full comment: dichlobenil

12002300 12   Nectarine                          0.040000   1.000      1.000

08002340 8    Okra                               0.010000   1.000      1.000

03002370 3    Onion, dry bulb                    0.010000   1.000      1.000   PP#737

  Full comment: PP#737172

03002371 3    Onion, dry bulb-babyfood           0.010000   1.000      1.000   PP#737

  Full comment: PP#737172

03002380 3    Onion, dry bulb, dried             0.010000   9.000      1.000   PP#737

  Full comment: PP#737172

03002381 3    Onion, dry bulb, dried-babyfood    0.010000   9.000      1.000   PP#737

  Full comment: PP#737172

03002390 3    Onion, green                       0.014000   1.000      1.000   PP#737

  Full comment: PP#737172

04012480 4A   Parsley, leaves                    0.188000   1.000      1.000

01012500 1AB  Parsley, turnip rooted             0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01012510 1AB  Parsnip                            0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01012511 1AB  Parsnip-babyfood                   0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

12002600 12   Peach                              0.040000   1.000      0.010

12002601 12   Peach-babyfood                     0.040000   1.000      0.010

12002610 12   Peach, dried                       0.040000   7.000      0.010

12002611 12   Peach, dried-babyfood              0.040000   7.000      0.010

12002620 12   Peach, juice                       0.040000   1.500      0.010

12002621 12   Peach, juice-babyfood              0.040000   1.500      0.010

11002660 11   Pear                               0.271000   1.000      0.010

11002661 11   Pear-babyfood                      0.271000   1.000      0.010

11002670 11   Pear, dried                        0.271000   6.250      0.010

11002680 11   Pear, juice                        0.271000   1.000      0.010

11002681 11   Pear, juice-babyfood               0.271000   1.000      0.010

08002700 8    Pepper, bell                       0.010000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.010000   1.000      1.000

08002710 8    Pepper, bell, dried                0.010000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.010000   1.000      1.000

08002720 8    Pepper, nonbell                    0.010000   1.000      1.000

08002721 8    Pepper, nonbell-babyfood           0.010000   1.000      1.000

08002730 8    Pepper, nonbell, dried             0.010000   1.000      1.000

12002850 12   Plum                               0.460000   1.000      1.000

12002851 12   Plum-babyfood                      0.460000   1.000      1.000

12002860 12   Plum, prune, fresh                 0.460000   1.000      1.000

12002861 12   Plum, prune, fresh-babyfood        0.460000   1.000      1.000

12002870 12   Plum, prune, dried                 0.460000   5.000      1.000

12002871 12   Plum, prune, dried-babyfood        0.460000   5.000      1.000

12002880 12   Plum, prune, juice                 0.460000   1.400      1.000

12002881 12   Plum, prune, juice-babyfood        0.460000   1.400      1.000

09023080 9B   Pumpkin                            0.010000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.010000   1.000      1.000

04013130 4A   Radicchio                          0.013200   1.000      1.000

01013140 1AB  Radish, roots                      0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

02003150 2    Radish, tops                       0.163000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01013160 1AB  Radish, Oriental, roots            0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

02003170 2    Radish, Oriental, tops             0.163000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

13013200 13A  Raspberry                          0.010000   1.000      0.050

13013201 13A  Raspberry-babyfood                 0.010000   1.000      0.050

13013210 13A  Raspberry, juice                   0.010000   1.000      0.050

13013211 13A  Raspberry, juice-babyfood          0.010000   1.000      0.050

04023220 4B   Rhubarb                            0.041000   1.000      1.000

01013270 1AB  Rutabaga                           0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

01013310 1AB  Salsify, roots                     0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

02003320 2    Salsify, tops                      0.163000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

03003380 3    Shallot                            0.014000   1.000      1.000   PP#737

  Full comment: PP#737172

04013550 4A   Spinach                            0.188000   1.000      1.000

04013551 4A   Spinach-babyfood                   0.188000   1.000      1.000

09023560 9B   Squash, summer                     0.010000   1.000      1.000

09023561 9B   Squash, summer-babyfood            0.010000   1.000      1.000

09023570 9B   Squash, winter                     0.010000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.010000   1.000      1.000

01033660 1CD  Sweet potato                       0.010000   1.000      1.000

01033661 1CD  Sweet potato-babyfood              0.010000   1.000      1.000

04023670 4B   Swiss chard                        0.041000   1.000      1.000

01033710 1CD  Tanier, corm                       0.010000   1.000      1.000

08003740 8    Tomatillo                          0.010000   1.000      1.000

08003750 8    Tomato                             0.010000   1.000      1.000

08003751 8    Tomato-babyfood                    0.010000   1.000      1.000

08003760 8    Tomato, paste                      0.010000   5.400      1.000

08003761 8    Tomato, paste-babyfood             0.010000   5.400      1.000

08003770 8    Tomato, puree                      0.010000   3.300      1.000

08003771 8    Tomato, puree-babyfood             0.010000   3.300      1.000

08003780 8    Tomato, dried                      0.010000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.010000  14.300      1.000

08003790 8    Tomato, juice                      0.010000   1.500      1.000

01033870 1CD  Turmeric                           0.010000   1.000      1.000

01013880 1AB  Turnip, roots                      0.010000   1.000      1.000   PP#7E7

  Full comment: PP#7E7172

86010000 O    Water, direct, all sources         0.056200   1.000      1.000

86020000 O    Water, indirect, all sources       0.056200   1.000      1.000

09013990 9A   Watermelon                         0.010000   1.000      1.000

09014000 9A   Watermelon, juice                  0.010000   1.000      1.000

01034060 1CD  Yam, true                          0.010000   1.000      1.000

01034070 1CD  Yam bean                           0.010000   1.000      1.000

Attachment 5:  Chronic Food Plus Water Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for 2,6-DICHLOROBENZAMIDE (BAM)      (1994-98 data)

Residue file name: C:\DEEMFCID\BAM\BAM_domestic_chronicPP7E7271.R98

                                                     Adjustment factor #2 used.

Analysis Date 03-18-2008/11:51:31     Residue file dated: 03-18-2008/11:51:13/8

Reference dose (RfD, Chronic) = .0045 mg/kg bw/day

COMMENT 1: New uses from PP#7E7172 + dichlobenil berries

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.001317                29.3%

U.S. Population (spring season)             0.001305                29.0%

U.S. Population (summer season)             0.001418                31.5%

U.S. Population (autumn season)             0.001268                28.2%

U.S. Population (winter season)             0.001275                28.3%

Northeast region                            0.001236                27.5%

Midwest region                              0.001322                29.4%

Southern region                             0.001244                27.6%

Western region                              0.001501                33.4%

Hispanics                                   0.001459                32.4%

Non-hispanic whites                         0.001295                28.8%

Non-hispanic blacks                         0.001237                27.5%

Non-hisp/non-white/non-black                0.001578                35.1%

All infants (< 1 year)                      0.004170                92.7%

Nursing infants                             0.001591                35.4%

Non-nursing infants                         0.005149               114.4%

Children 1-6  yrs                           0.002037                45.3%

Children 7-12 yrs                           0.001225                27.2%

Females 13-19 (not preg or nursing)         0.000912                20.3%

Females 20+ (not preg or nursing)           0.001293                28.7%

Females 13-50 yrs                           0.001244                27.7%

Females 13+ (preg/not nursing)              0.001246                27.7%

Females 13+ (nursing)                       0.001742                38.7%

Males 13-19 yrs                             0.000941                20.9%

Males 20+ yrs                               0.001155                25.7%

Seniors 55+                                 0.001292                28.7%

Children 1-2 yrs                            0.002284                50.7%

Children 3-5 yrs                            0.001985                44.1%

Children 6-12 yrs                           0.001297                28.8%

Youth 13-19 yrs                             0.000930                20.7%

Adults 20-49 yrs                            0.001196                26.6%

Adults 50+ yrs                              0.001288                28.6%

Females 13-49 yrs                           0.001196                26.6%

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

Attachment 6:  Screening Level Estimates of Agricultural Uses of Dichlobenil

-

"

#

$

3

C

3

L

a

b

Š

¤

Ý

萎ｌ萏ୀ萑褐葝ｌ葞ୀ葠褐摧⺬%฀C

D

K

L

V

Y

[

_

a

j

k

l

‰

Š

£

¤

(

.

f

g

n

t

›

œ

¨

¯

°

±

³

¹

(

)

J

o

s

t

œ

º

Í

Î

¹

º

»

Í

Î

Ù

ß

à

ç

è

ò

@

@

@

  h

  h

kdE

kd•

kd

$

kd

摧fHࠀ

kd

h

#

ó

h

h

@

@

@

愀Ĥ摧ಊTԀ

&

&

h

&

&

@

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

@

h

h

h

h

&

@

@

@

&

@

 h

  h

  h

h

gd

 h

  h

h

gd

@

@

@

 h

 h

# h

h

h

@

gd

@

@

gd

e

µ

E

•

å

@

@

Cherries	2,000	<1	<2.5

Cranberries	30,000	45	--

Grapes	3,000	<1	<2.5

Peaches	1,000	<1	<2.5

Pears	<500	<1	<2.5

Raspberries	1,000	  5	  5

Strawberries*	<500	<1	<2.5

*No tolerance is established on strawberries.

2,6-Dichlorobenzamide (BAM)          Dietary Exposure and Risk Assessment               DP Number: 349722

& Fluopicolide

PC Codes: 027402 and 027412

________________________________________________________________________ ______________

 PAGE   8

Page   PAGE  1  of   NUMPAGES  29


[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Page 47094]
[FR Doc No: 2021-18055]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP21-441-003.
    Applicants: Florida Gas Transmission Company, LLC submits.
    Description: Submits tariff filing per 154.203: File & Motion
Revised & Cancelled Tariff Records--RP21-441-000 to be effective 8/1/
2021.
    Filed Date: 7/29/21.
    Accession Number: 20210729[not]5057.
    Comment Date: 8/20/21.

    Docket Numbers: RP21-1033-000.
    Applicants: Six One Commodities LLC, Six One Commodities Vega LLC.
    Description: Joint Petition for Temporary Waiver of Capacity
Release Regulations, et al. of Six One Commodities LLC, et al.
    Filed Date: 8/13/21.
    Accession Number: 20210813-5127.
    Comment Date: 5 pm ET 8/25/21.

    Docket Numbers: RP21-1034-000.
    Applicants: Eastern Gas Transmission and Storage, Inc.
    Description: Sec.  4(d) Rate Filing: EGTS--August 16, 2021
Administrative Change to be effective 9/16/2021.
    Filed Date: 8/16/21.
    Accession Number: 20210816-5051.
    Comment Date: 5 pm ET 8/30/21.

    Docket Numbers: RP21-1035-000.
    Applicants: Cove Point LNG, LP.
    Description: Sec.  4(d) Rate Filing: Cove Point--August 16, 2021
Administrative Filing to be effective 9/16/2021.
    Filed Date: 8/16/21.
    Accession Number: 20210816-5053.
    Comment Date: 5 pm ET 8/30/21.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at:http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 17, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-18055 Filed 8-20-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]
[Page 7951-7952]
[DOCID:fr15fe06-58]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0145; FRL-7759-3]

Notice of Filing of a Pesticide Petition for the Amendment of a
Regulation for the Fungicide Boscalid in or on Strawberry and Berries
(Crop Group 13) Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the amendment of a regulation for residues of the
fungicide boscalid (BAS 510F), 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro(1,1'-biphenyl)-2-yl in or on strawberry and berries (Crop Group
13) commodities.

DATES: Comments must be received on or before March 17, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0145 and pesticide petition number (PP)
5F6986, by one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2005-0145. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0145. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov

or e-mail. The http://www.regulations.gov website is an ``anonymous access''

system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
http://www.regulations.gov, your e-mail address will be captured automatically

and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm/
.

    Docket: All documents in the docket are listed in the
http://www.regulation.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Public Information and

Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs
(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the docket facility is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System

(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed underFOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
     Identify the document by docket ID number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the amendment of regulations in 40 CFR part 180
for residues of the fungicide boscalid (BAS 510F), 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro(1,1'-biphenyl)-2-yl in or on
strawberry and berries (Crop Group 13) commodities. EPA has determined
that this pesticide petition contains data or information regarding the
elements set forth in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petition. Additional
data may be needed before EPA rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition prepared by
the petitioner along with a description of the analytical method
available for the detection and measurement of the pesticide chemical
residues is available on EPA's Electronic Docket at http://www.regulations.gov/.
 To locate this information on the home page of

EPA's Electronic Docket, select ``Quick Search'' and type OPP docket ID
number ``EPA-HQ-OPP-2005-0145.'' Once the search has located the
docket, clicking on the ``Docket ID'' will bring up a list of all
documents in the docket for the pesticide including the petition
summary.

Amendment to Existing Tolerance

    PP 5F6986. BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709, proposes to amend the tolerances in
40 CFR 180.589 by increasing the tolerance for residues of the
fungicide boscalid (BAS 510F), 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro(1,1'-biphenyl)-2-yl in or on the food commodity strawberry from
1.2 to 4.0 parts per million (ppm); and increasing the tolerance in or
on the food commodity berries (Crop Group 13) to 8.0 ppm. In plants,
the parent residue is extracted using an aqueous organic solvent
mixture followed by liquid/liquid partitioning and a column clean-up.
Quantitation is by gas chromatography using mass spectrometry (GS/MS).
In livestock, the residues are extracted with methanol. The extract is
treated with enzymes in order to release the conjugated glucuronic acid
metabolite. The residues are then isolated by liquid/liquid
partitioning followed by column chromatography. The hydroxylated
metabolite is acetylated followed by a column clean-up. The parent and
acetylated metabolite are quantitated by gas chromatography with
electron capture detection.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: February 7, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-2147 Filed 2-14-06; 8:45 am]

BILLING CODE 6560-50-S