UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	08 - JAN-2007

SUBJECT:	Lactofen Acute, Chronic, and Cancer Aggregate Dietary and Drinking Water Exposure and Risk Assessments for the Section 3 Registration Action

PC Code:	128888			Decision Number: 356302

DP Number:	D333149

REVIEWER:	Christine L. Olinger, Chemist

		Reregistration Branch 1

Health Effects Division (7509P)

THROUGH:	Douglas Dotson, Chemist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

And

Michael S. Metzger, Chief

		Reregistration Branch 1

Health Effects Division (7509P)

TO:		Barbara Madden

Minor Use and Emergency Response Branch

Registration Division (7505P)

			And

Dan Kenny/Joanne Miller

Herbicide Branch

Registration Division (7505P)

And

Amaris Johnson/Susan Lewis

Reregistration Branch 1

Special Review and Reregistration Division (7508P)

Executive Summary

Acute, chronic, and cancer dietary risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID™, Version [2.03]) which uses 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 to support a request for regional registration of lactofen on fruiting vegetables and okra.

All of the assessments assumed tolerance level residues of lactofen in all commodities and that all commodities consumed were treated.  The dietary exposures for food alone and food and drinking water are well below the level of concern for all populations for acute and chronic exposures.  This is a highly conservative assessment and actual exposure is likely to be lower.

Acifluorfen, a registered herbicide, is an environmental degradate of lactofen and may be found in drinking water as a result of lactofen applications.  Therefore, aggregate acute and chronic assessments were conducted assuming tolerance level residues of acifluorfen and modeled estimates of acifluorfen in drinking water as a result of application of lactofen.  All of the exposure estimates were below the level of concern for all populations.

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 the reference dose (RfD) divided by the Food Quality Protection Act (FQPA) Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million (i.e., the risk exceeds 1 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,” 6/21/2000, 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 (8/20/99).  The most recent dietary risk assessment for lactofen was conducted by Felecia Fort (10/30/02, DP 269311).

II.	Residue Information

Lactofen is an early season herbicide currently registered for use on cottonseed, peanuts, snap beans and soybeans.  The tolerances are listed in 40 CFR 180.432 and were reassessed in 2003.  On April 4, 2000, the Metabolism Assessment Review Committee (MARC) determined that the dietary analysis should be based on the parent, lactofen only.

Residue Data used for Acute, Chronic, and/or Cancer Assessments:

Tolerance levels were used in the acute, chronic, and cancer assessments for lactofen and are listed in Table 1 below.

Table 1.  Tolerance Levels Used in Lactofen Dietary Assessment

Crop	Tolerance Level, ppm

Existing Tolerances

   Beans, Snap	0.01

   Cotton, Gin Byproducts	0.02

   Cotton, undelinted seed	0.01

   Peanut	0.01

   Soybean, seed	0.01

Proposed Tolerances

   Fruiting Vegetables	0.02

   Okra	0.02

An aggregate assessment for acifluorfen was also conducted because acifluorfen is an environmental degradate of lactofen.  Tolerance values for acifluorfen (40 CFR § 180.383) were used and may be found in Table 2.

Table 2.  Tolerance Levels Used in Acifluorfen Dietary Assessment

Crop	Tolerance Level, ppm

Peanut	0.1

Rice, grain	0.1

Soybean	0.1

Strawberry	0.05

No concentration, reduction, or processing factors were used in this assessment, as concentration of residues was not observed in processing studies.  Although a tomato processing study was not submitted for lactofen, no residues were detected in exaggerated rate field trials.  Therefore, residues exceeding the proposed tolerance would not be expected in tomato processed commodities.

 Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: “Drinking water and aquatic exposure water assessments for IR4 Tolerance petition for the new use (R17) of lactofen on the fruiting vegetable group and okra.” (J. Wolf, D319594, 10/13/06) and incorporated directly into this dietary assessment.  Acifluorfen is an environmental degradate of lactofen that could potentially be found in drinking water, and is also an environmental degradate of another registered herbicide, sodium acifluorfen.  Therefore, EFED estimated drinking water concentrations for both lactofen and acifluorfen from lactofen applications, and acifluorfen from sodium acifluorfen applications.  However, only the contribution from lactofen applications was incorporated into the acifluorfen aggregate assessment as lactofen and sodium acifluorfen are not likely to be used in the same area and the estimated concentrations from the proposed new uses of lactofen were higher than the sodium acifluorfen estimates.  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The Tier 2 surface water estimated drinking water concentrations (EDWCs) for lactofen and acifluorfen (a degradate of lactofen) were generated with standard Florida pepper and Florida tomato cropping scenarios using PRZM3 and EXAMS, and may be found in Table 3.  PRZM simulates pesticide fate and transport as a result of leaching, direct spray drift, runoff and erosion from an agricultural field and EXAMS estimates environmental fate and transport of pesticides in a surface water body for a 30-year period (1961-1990).  PRZM and EXAMS were linked by the program PE4-PL (version 01).  The EDWC assessment for surface water uses single or multiple sites which typically represent a high-end exposure scenario from pesticide use on a particular cropped or non-cropped site.  Ground-water concentrations were estimated using the Tier 1 screening model SCI-GROW and may be found in Table 4.  The model and its description are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

Table 3.  Estimated Drinking Water Concentrations (EDWC) In Surface Water Lactofen And The Acifluorfen Derived From Lactofen

Crop	Chemical Species	1-in-10 year

Maximum/mean (μg/L)	Long term average Mean (30 yrs.) (µg/L)

Acute	Chronic	Cancer

 Pepper	Lactofen	1.48	0.040	0.033

	Acifluorfen	22.5	3.5	2.0

 Tomato	Lactofen	1.13	0.044	0.039

	Acifluorfen	20.9	3.9 	1.7

Estimated drinking water concentrations (EDWC) (μg/L) were estimated using linked PRZM/EXAMS and Index Reservoir (IR) and Percent Crop Area (PCA) for surface water.  Bolded values were incorporated into the dietary exposure model

Table 4. SCI-GROW Estimates Of Lactofen And Acifluorfen EDWCs In Ground Water From Application of Lactofen

Chemical	Acute and Chronic (µg/L)

Lactofen	0.006

Acifluorfen	2.00

.	DEEM-FCID™ Program and Consumption Information

Lactofen and acifluorfen acute, chronic, and cancer 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 tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

On February 22, 2000 the Health Effects Division (HED) Hazard Identification Assessment Review Committee (HIARC) evaluated the toxicology database for lactofen, re-assessed the existing reference dose, and selected the doses and toxicological endpoints for dietary and non-dietary exposure risk assessments (C. Olinger, D269621, 10/12/00).  A summary of the doses and toxicity endpoints selected for use in the various human health risk assessments for lactofen is presented in Table 5.

In response to the preliminary risk assessment for the Tolerance Reassessment Decision, the registrant submitted a proposed mechanism of toxicity for the carcinogenicity observed in the chronic rodent studies.  The Mechanism of Toxicity Assessment Review Committee (MTARC) determined that the carcinogenicity should be assessed using a margin of exposure approach (Robert F. Fricke, 3/12/2001, DP Barcode:  D267472).  The Cancer Assessment Review Committee (CARC) concurred with the MTARC’s conclusion and classified lactofen as likely to be carcinogenic to humans at high enough doses to cause the biochemical and histopathological changes in the liver of rodents, but unlikely to be carcinogenic to humans below doses causing these changes.

Table 5.  Summary of Toxicological Doses and Endpoints for Lactofen for Use in Dietary Exposure Assessment

Exposure

Scenario	Dose Used in Risk

Assessment, UF	Hazard and Exposure Based FQPA Safety Factor	Study and Toxicological Effects

Acute Dietary

General US pop.	No endpoint has been identified for the general population based on a single exposure to lactofen.

Acute Dietary

Females (13+ years old)	LOAEL = 5 mg/kg/day

Acute RfD = 0.017 mg/kg/day

aPAD = 0.017 mg/kg/day	UF = 100

FQPA SF= 3x

(use of a LOAEL to extrapolate a NOAEL)	Developmental Toxicity Study – Rabbit

LOAEL was 5 mg/kg based on decrease in live young per litter accompanied by increases in post implantation loss and in early embryonic death/litter.

Chronic Dietary

All Populations	NOAEL= 0.79 mg/kg/day

UF = 100

Chronic RfD =  0.008 mg/kg/day

	FQPA SF = 1

cPAD = 0.008 mg/kg/day

	Chronic Oral Toxicity Study - Dog

LOAEL = 3.96 mg/kg/day based on Increased incidence of proteinaceous casts in the kidneys and statistically significant decreases in the absolute weight of thyroid and adrenal glands in males.

Cancer	Classification: Not likely to be carcinogenic to humans at doses that do not cause the biochemical and histopathological changes in the liver of rodents.  The chronic endpoint is protective of the carcinogenic effects so a separate cancer assessment is not needed.

The toxicological endpoints for acute and chronic dietary exposures are discussed in detail in the revised Health Effects chapter to the Sodium Acifluorfen RED (K. Farwell, 1/15/2002, DP Barcode D279497) and are found in Table 6.  Like lactofen, the cancer classification for acifluorfen was changed as a result of the submission of mechanistic studies and is now assessed using an MOE approach (K. Farwell, 7/13/2003, DP Barcode D291742)

Table 6.  Summary of Toxicological Doses and Endpoints for Acifluorfen for Use in Dietary Exposure Assessment

Exposure

Scenario	Dose Used in Risk

Assessment, UF	Hazard and Exposure Based FQPA Safety Factor	Study and Toxicological Effects

Acute Dietary

General US pop.	No endpoint has been identified for the general population based on a single exposure to acifluorfen.

Acute Dietary

Females (13+ years old)	NOAEL = 20 mg/kg/day

UF = 100

Acute RfD = 0.2 mg/kg/day	FQPA SF = 10

aPAD = 0.02 mg/kg/day

(database uncertainty factor for lack of developmental neurotoxicity study)	Developmental Toxicity Study – Rabbit

LOAEL = 90 mg/kg/day based on Decreased fetal weight and increased incidences of dilated lateral ventricles of the brain.

Chronic Dietary

All Populations	NOAEL= 1.25 mg/kg/day

Chronic RfD = 0.013 mg/kg/day

cPAD = 0.0013 mg/kg/day	FQPA SF = 10

UFA = 10x

UFH = 10x

FQPA SF= 10x

(database uncertainty factor for lack of developmental neurotoxicity study)	2- Generation Reproduction Study - Rat

LOAEL = 25 mg/kg/day based on Kidney lesions (dilatation of tubules in outer medulla)

Cancer	Not likely to be carcinogenic to humans at doses that do not cause biochemical and histopathological changes in livers of.  The chronic endpoint is protective of the carcinogenic effects so a separate cancer assessment is not needed.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table(s) 7, 8, and 9 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.

Results of Acute Dietary Exposure Analysis

No endpoints were identified for the general population so the only assessment was conducted for Females ages 13-49.  The results of the acute dietary exposure analyses for lactofen are reported in Tables 7 for food alone and Table 8 for food and drinking water.  The results of the acute dietary exposure analyses for acifluorfen are reported in Table 9 for food (from acifluorfen applications and drinking water (as an environmental degradate of lactofen).   All exposures are below the level of concern, with the lactofen assessments at less than 1% of the aPAD and the acifluorfen assessment at 6% of the aPAD.

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary exposure analyses for lactofen are reported in Tables 7 for food alone and Table 8 for food and drinking water.  The results of the chronic dietary exposure analyses for acifluorfen are reported in Table 9 for food (from acifluorfen applications and drinking water (as an environmental degradate of lactofen).   All exposures are below the level of concern, with the lactofen assessments at less than 1% of the aPAD.  The most highly exposed subgroup in the acifluorfen assessment at 37% of the cPAD was infants, less than one year old.

Table 7.  Summary of Dietary Exposure and Risk for Lactofen – Food Only

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary

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

(mg/kg/day)	% cPAD

General U.S. Population	N/A	N/A	0.000024	<1

All Infants (< 1 year old)

	0.000024	<1

Children 1-2 years old

	0.000051	<1

Children 3-5 years old

	0.000047	<1

Children 6-12 years old

	0.000032	<1

Youth 13-19 years old

	0.000022	<1

Adults 20-49 years old

	0.000021	<1

Adults 50+ years old

	0.000019	<1

Females 13-49 years old	0.000066	<1	0.000020	<1

Table 8.  Summary of Dietary Exposure and Risk for Lactofen – Food and Drinking Water

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary

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

General U.S. Population	N/A	N/A	0.000025	<1

All Infants (< 1 year old)

	0.000027	<1

Children 1-2 years old

	0.000052	<1

Children 3-5 years old

	0.000048	<1

Children 6-12 years old

	0.000033	<1

Youth 13-19 years old

	0.000023	<1

Adults 20-49 years old

	0.000022	<1

Adults 50+ years old

	0.000020	<1

Females 13-49 years old	0.000066	<1	0.000021	<1

Table 9.  Summary of Dietary Exposure and Risk for Acifluorfen – Food and Drinking Water (Acifluorfen in Drinking Water From Lactofen Applications)

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary

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

(mg/kg/day)	% cPAD

General U.S. Population	N/A	N/A	0.00017	13

All Infants (< 1 year old)

	0.000478	37

Children 1-2 years old

	0.000324	25

Children 3-5 years old

	0.00031	24

Children 6-12 years old

	0.00021	16

Youth 13-19 years old

	0.000142	11

Adults 20-49 years old

	0.000151	12

Adults 50+ years old

	0.000135	10

Females 13-49 years old	0.00119	6.0	0.000143	11

VII.	Characterization of Inputs/Outputs

The acute, chronic, and cancer dietary exposure assessments can be considered highly conservative assessments because they assume all food consumed bears residues at the tolerance level and all water consumed has lactofen and acifluorfen in it at levels comparable to an agricultural area.  Actual exposure to lactofen and acifluorfen is likely to be much lower.

VIII.	Conclusions

Acute, chronic, and cancer dietary exposure assessments were conducted for lactofen and acifluorfen, an environmental degradate of lactofen, including existing uses and proposed uses of lactofen on fruiting vegetables and okra.  All assessments for food alone, and food plus modeled estimates of drinking water concentrations were below the level of concern.  The assessments can be considered highly conservative as they assumed all the subject crops are treated and bear residues at the tolerance level.  Actual exposure is likely to be much lower.

IX.		List of Attachments

Acute Food Residue Input File - Lactofen

Acute Food plus Water Residue Input File - Lactofen

Acute Food Results File - Lactofen

Acute Food plus Water Results File - Lactofen

Acute Food plus Water Residue Input File - Acifluorfen

Acute Food plus Water Results File - Acifluorfen

Chronic Food Residue Input File - Lactofen

Chronic Food plus Water Residue Input File - Lactofen

Chronic Food Results File - Lactofen

Chronic Food plus Water Results File - Lactofen

Chronic Food plus Water Residue Input File – Acifluorfen – General Population

Chronic Food plus Water Results File – Acifluorfen – General Population

cc:	Colinger

Acute Food Residue Input File – Lactofen

 Filename: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\LactofenAcuteTier1Fruitingveggiefoo donly.R98

Chemical: Lactofen

RfD(Chronic): .008 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .017 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 12-21-2006/11:00:21/8          Program ver. 2.03

Comment: Food Only;  Acute endpoint 5 LOAEL; 3x FQPA

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

06010430 6A   Bean, snap, succulent              0.010000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.010000   1.000  1.000

95001280 O    Cottonseed, oil                    0.010000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.010000   1.000  1.000

08001480 8    Eggplant                           0.020000   1.000  1.000

08002340 8    Okra                               0.020000   1.000  1.000

95002630 O    Peanut                             0.010000   1.000  1.000

95002640 O    Peanut, butter                     0.010000   1.000  1.000

95002650 O    Peanut, oil                        0.010000   1.000  1.000

08002700 8    Pepper, bell                       0.020000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.020000   1.000  1.000

08002710 8    Pepper, bell, dried                0.020000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000  1.000

08002720 8    Pepper, nonbell                    0.020000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.020000   1.000  1.000

06003470 6    Soybean, seed                      0.010000   1.000  1.000

06003480 6    Soybean, flour                     0.010000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000  1.000

06003490 6    Soybean, soy milk                  0.010000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000  1.000

06003500 6    Soybean, oil                       0.010000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000  1.000

08003740 8    Tomatillo                          0.020000   1.000  1.000

08003750 8    Tomato                             0.020000   1.000  1.000

08003751 8    Tomato-babyfood                    0.020000   1.000  1.000

08003760 8    Tomato, paste                      0.020000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.020000   1.000  1.000

08003770 8    Tomato, puree                      0.020000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.020000   1.000  1.000

08003780 8    Tomato, dried                      0.020000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.020000   1.000  1.000

08003790 8    Tomato, juice                      0.020000   1.000  1.000

Acute Food plus Water Residue Input File – Lactofen

 Filename: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\LactofenTier1AcuteFruitingveggiefoo dandwaterLOAEL5.R98

Chemical: Lactofen

RfD(Chronic): .008 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .017 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 11-09-2006/13:28:43/8          Program ver. 2.03

Comment: Food and water;  surface at 1.48; acute at 0.017 - 5 LOAEL, 3X FQPA

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

06010430 6A   Bean, snap, succulent              0.010000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.010000   1.000  1.000

95001280 O    Cottonseed, oil                    0.010000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.010000   1.000  1.000

08001480 8    Eggplant                           0.020000   1.000  1.000

08002340 8    Okra                               0.020000   1.000  1.000

95002630 O    Peanut                             0.010000   1.000  1.000

95002640 O    Peanut, butter                     0.010000   1.000  1.000

95002650 O    Peanut, oil                        0.010000   1.000  1.000

08002700 8    Pepper, bell                       0.020000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.020000   1.000  1.000

08002710 8    Pepper, bell, dried                0.020000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000  1.000

08002720 8    Pepper, nonbell                    0.020000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.020000   1.000  1.000

06003470 6    Soybean, seed                      0.010000   1.000  1.000

06003480 6    Soybean, flour                     0.010000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000  1.000

06003490 6    Soybean, soy milk                  0.010000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000  1.000

06003500 6    Soybean, oil                       0.010000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000  1.000

08003740 8    Tomatillo                          0.020000   1.000  1.000

08003750 8    Tomato                             0.020000   1.000  1.000

08003751 8    Tomato-babyfood                    0.020000   1.000  1.000

08003760 8    Tomato, paste                      0.020000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.020000   1.000  1.000

08003770 8    Tomato, puree                      0.020000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.020000   1.000  1.000

08003780 8    Tomato, dried                      0.020000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.020000   1.000  1.000

08003790 8    Tomato, juice                      0.020000   1.000  1.000

86010000 O    Water, direct, all sources         0.001480   1.000  1.000

86020000 O    Water, indirect, all sources       0.001480   1.000  1.000

Acute Food Results File – Lactofen

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for LACTOFEN                            (1994-98 data)

Residue file: LactofenAcuteTier1Fruitingveggiefoodonly.R98

Adjustment factor #2 NOT used.

Analysis Date: 12-21-2006/11:08:19    Residue file dated: 12-21-2006/11:05:29/8

Daily totals for food and foodform consumption used.

Run Comment: "Food Only;  Acute endpoint 5 LOAEL; 3x FQPA"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Females 13-49 yrs:

                    0.000066     0.39    0.000109     0.64    0.000231     1.36

Acute Food plus Water Results File – Lactofen

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for LACTOFEN                            (1994-98 data)

Residue file: LactofenTier1AcuteFruitingveggiefoodandwaterLOAEL5.R98

Adjustment factor #2 NOT used.

Analysis Date: 12-21-2006/11:09:37    Residue file dated: 12-21-2006/11:04:52/8

Daily totals for food and foodform consumption used.

Run Comment: "Food and water;  surface at 1.48; acute at 0.017 - 5 LOAEL, 3X F

QPA"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Females 13-49 yrs:

                    0.000112     0.66    0.000168     0.99    0.000330     1.94

Acute Food plus Water Residue Input File – Acifluorfen

Filename: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\AcifluorfenTier1AcuteFoodandWater.R 98

Chemical: Acifluorfen

RfD(Chronic): .004 mg/kg bw/day  NOEL(Chronic): 1.25 mg/kg bw/day

RfD(Acute): .02 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-23-2006/10:22:37/8          Program ver. 2.03

Comment: Acifluorfen Tolerance and Water from Lactofen Applications - Water at 22.5 ppb

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95002630 O    Peanut                             0.100000   1.000  1.000

95002640 O    Peanut, butter                     0.100000   1.000  1.000

95002650 O    Peanut, oil                        0.100000   1.000  1.000

15003230 15   Rice, white                        0.100000   1.000  1.000

15003231 15   Rice, white-babyfood               0.100000   1.000  1.000

15003240 15   Rice, brown                        0.100000   1.000  1.000

15003241 15   Rice, brown-babyfood               0.100000   1.000  1.000

15003250 15   Rice, flour                        0.100000   1.000  1.000

15003251 15   Rice, flour-babyfood               0.100000   1.000  1.000

15003260 15   Rice, bran                         0.100000   1.000  1.000

15003261 15   Rice, bran-babyfood                0.100000   1.000  1.000

06003470 6    Soybean, seed                      0.100000   1.000  1.000

06003480 6    Soybean, flour                     0.100000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.100000   1.000  1.000

06003490 6    Soybean, soy milk                  0.100000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.100000   1.000  1.000

06003500 6    Soybean, oil                       0.100000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.100000   1.000  1.000

95003590 O    Strawberry                         0.050000   1.000  1.000

95003591 O    Strawberry-babyfood                0.050000   1.000  1.000

95003600 O    Strawberry, juice                  0.050000   1.000  1.000

95003601 O    Strawberry, juice-babyfood         0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.022500   1.000  1.000

86020000 O    Water, indirect, all sources       0.022500   1.000  1.000

Acute Food plus Water Results File – Acifluorfen

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ACIFLUORFEN                         (1994-98 data)

Residue file: AcifluorfenTier1AcuteFoodandWater.R98

Adjustment factor #2 NOT used.

Analysis Date: 10-23-2006/10:25:02    Residue file dated: 10-23-2006/10:22:37/8

Daily totals for food and foodform consumption used.

Run Comment: "Acifluorfen Tolerance and Water from Lactofen Applications - Wat

er at 22.5 ppb"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Females 13-49 yrs:

                    0.001190     5.95    0.001925     9.62    0.003200    16.00

Chronic Food Residue Input File – Lactofen

Filename: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\LactofenTier1Fruitingveggie.R98

Chemical: Lactofen

RfD(Chronic): .008 mg/kg bw/day  NOEL(Chronic): .3 mg/kg bw/day

RfD(Acute): .04 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-26-2006/14:26:02/8          Program ver. 2.03

Comment: Food Only

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

06010430 6A   Bean, snap, succulent              0.010000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.010000   1.000  1.000

95001280 O    Cottonseed, oil                    0.010000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.010000   1.000  1.000

08001480 8    Eggplant                           0.020000   1.000  1.000

08002340 8    Okra                               0.020000   1.000  1.000

95002630 O    Peanut                             0.010000   1.000  1.000

95002640 O    Peanut, butter                     0.010000   1.000  1.000

08002700 8    Pepper, bell                       0.020000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.020000   1.000  1.000

08002710 8    Pepper, bell, dried                0.020000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000  1.000

08002720 8    Pepper, nonbell                    0.020000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.020000   1.000  1.000

06003470 6    Soybean, seed                      0.010000   1.000  1.000

06003480 6    Soybean, flour                     0.010000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000  1.000

06003490 6    Soybean, soy milk                  0.010000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000  1.000

06003500 6    Soybean, oil                       0.010000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000  1.000

08003740 8    Tomatillo                          0.020000   1.000  1.000

08003750 8    Tomato                             0.020000   1.000  1.000

08003751 8    Tomato-babyfood                    0.020000   1.000  1.000

08003760 8    Tomato, paste                      0.020000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.020000   1.000  1.000

08003770 8    Tomato, puree                      0.020000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.020000   1.000  1.000

08003780 8    Tomato, dried                      0.020000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.020000   1.000  1.000

08003790 8    Tomato, juice                      0.020000   1.000  1.000

Chronic Food plus Water Residue Input File – Lactofen

Filename: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\LactofenTier1ChronicFruitingveggief oodandwater.R98

Chemical: Lactofen

RfD(Chronic): .008 mg/kg bw/day  NOEL(Chronic): .3 mg/kg bw/day

RfD(Acute): .17 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-17-2006/10:09:53/8          Program ver. 2.03

Comment: Food and water; acute with 10x; surface at 1.48

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

06010430 6A   Bean, snap, succulent              0.010000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.010000   1.000  1.000

95001280 O    Cottonseed, oil                    0.010000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.010000   1.000  1.000

08001480 8    Eggplant                           0.020000   1.000  1.000

08002340 8    Okra                               0.020000   1.000  1.000

95002630 O    Peanut                             0.010000   1.000  1.000

95002640 O    Peanut, butter                     0.010000   1.000  1.000

08002700 8    Pepper, bell                       0.020000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.020000   1.000  1.000

08002710 8    Pepper, bell, dried                0.020000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000  1.000

08002720 8    Pepper, nonbell                    0.020000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.020000   1.000  1.000

06003470 6    Soybean, seed                      0.010000   1.000  1.000

06003480 6    Soybean, flour                     0.010000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000  1.000

06003490 6    Soybean, soy milk                  0.010000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000  1.000

06003500 6    Soybean, oil                       0.010000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000  1.000

08003740 8    Tomatillo                          0.020000   1.000  1.000

08003750 8    Tomato                             0.020000   1.000  1.000

08003751 8    Tomato-babyfood                    0.020000   1.000  1.000

08003760 8    Tomato, paste                      0.020000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.020000   1.000  1.000

08003770 8    Tomato, puree                      0.020000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.020000   1.000  1.000

08003780 8    Tomato, dried                      0.020000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.020000   1.000  1.000

08003790 8    Tomato, juice                      0.020000   1.000  1.000

86010000 O    Water, direct, all sources         0.000044   1.000  1.000

86020000 O    Water, indirect, all sources       0.000044   1.000  1.000

Chronic Food Results File – Lactofen

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for LACTOFEN                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\LactofenTier1Fruitingveggie.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 10-26-2006/14:28:39     Residue file dated: 10-26-2006/14:26:02/8

Reference dose (RfD, Chronic) = .008 mg/kg bw/day

COMMENT 1: Food Only

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000024                 0.3%

U.S. Population (spring season)             0.000023                 0.3%

U.S. Population (summer season)             0.000025                 0.3%

U.S. Population (autumn season)             0.000024                 0.3%

U.S. Population (winter season)             0.000024                 0.3%

Northeast region                            0.000024                 0.3%

Midwest region                              0.000024                 0.3%

Southern region                             0.000023                 0.3%

Western region                              0.000026                 0.3%

Hispanics                                   0.000029                 0.4%

Non-hispanic whites                         0.000024                 0.3%

Non-hispanic blacks                         0.000022                 0.3%

Non-hisp/non-white/non-black                0.000028                 0.3%

All infants (< 1 year)                      0.000024                 0.3%

Nursing infants                             0.000010                 0.1%

Non-nursing infants                         0.000029                 0.4%

Children 1-6  yrs                           0.000047                 0.6%

Children 7-12 yrs                           0.000031                 0.4%

Females 13-19 (not preg or nursing)         0.000021                 0.3%

Females 20+ (not preg or nursing)           0.000020                 0.2%

Females 13-50 yrs                           0.000022                 0.3%

Females 13+ (preg/not nursing)              0.000022                 0.3%

Females 13+ (nursing)                       0.000022                 0.3%

Males 13-19 yrs                             0.000024                 0.3%

Males 20+ yrs                               0.000022                 0.3%

Seniors 55+                                 0.000019                 0.2%

Children 1-2 yrs                            0.000051                 0.6%

Children 3-5 yrs                            0.000047                 0.6%

Children 6-12 yrs                           0.000032                 0.4%

Youth 13-19 yrs                             0.000022                 0.3%

Adults 20-49 yrs                            0.000021                 0.3%

Adults 50+ yrs                              0.000019                 0.2%

Females 13-49 yrs                           0.000020                 0.3%

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

Chronic Food plus Water Results File – Lactofen

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for LACTOFEN                         (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\LactofenTier1ChronicFruitingveggief oodandwater.R98                                         Adjustment factor #2 NOT used.

Analysis Date 10-17-2006/10:12:28     Residue file dated: 10-17-2006/10:09:53/8

Reference dose (RfD, Chronic) = .008 mg/kg bw/day

COMMENT 1: Food and water; acute with 10x; Water at 0.044 ppb

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000025                 0.3%

U.S. Population (spring season)             0.000024                 0.3%

U.S. Population (summer season)             0.000026                 0.3%

U.S. Population (autumn season)             0.000025                 0.3%

U.S. Population (winter season)             0.000025                 0.3%

Northeast region                            0.000025                 0.3%

Midwest region                              0.000025                 0.3%

Southern region                             0.000024                 0.3%

Western region                              0.000027                 0.3%

Hispanics                                   0.000030                 0.4%

Non-hispanic whites                         0.000025                 0.3%

Non-hispanic blacks                         0.000023                 0.3%

Non-hisp/non-white/non-black                0.000029                 0.4%

All infants (< 1 year)                      0.000027                 0.3%

Nursing infants                             0.000012                 0.1%

Non-nursing infants                         0.000033                 0.4%

Children 1-6  yrs                           0.000048                 0.6%

Children 7-12 yrs                           0.000032                 0.4%

Females 13-19 (not preg or nursing)         0.000021                 0.3%

Females 20+ (not preg or nursing)           0.000020                 0.3%

Females 13-50 yrs                           0.000023                 0.3%

Females 13+ (preg/not nursing)              0.000023                 0.3%

Females 13+ (nursing)                       0.000023                 0.3%

Males 13-19 yrs                             0.000025                 0.3%

Males 20+ yrs                               0.000023                 0.3%

Seniors 55+                                 0.000020                 0.3%

Children 1-2 yrs                            0.000052                 0.7%

Children 3-5 yrs                            0.000048                 0.6%

Children 6-12 yrs                           0.000033                 0.4%

Youth 13-19 yrs                             0.000023                 0.3%

Adults 20-49 yrs                            0.000022                 0.3%

Adults 50+ yrs                              0.000020                 0.3%

Females 13-49 yrs                           0.000021                 0.3%

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

Chronic Food plus Water Residue Input File – Acifluorfen – General Population

Filename: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\AcifluorfenTier1ChronicFoodandWater genpop.R98

Chemical: Acifluorfen

RfD(Chronic): .0013 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .02 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 11-07-2006/09:22:39/8          Program ver. 2.03

Comment: Acifluorfen Tolerance and Water from Lactofen Applications - Water at 3.9 ppb

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95002630 O    Peanut                             0.100000   1.000  1.000

95002640 O    Peanut, butter                     0.100000   1.000  1.000

95002650 O    Peanut, oil                        0.100000   1.000  1.000

15003230 15   Rice, white                        0.100000   1.000  1.000

15003231 15   Rice, white-babyfood               0.100000   1.000  1.000

15003240 15   Rice, brown                        0.100000   1.000  1.000

15003241 15   Rice, brown-babyfood               0.100000   1.000  1.000

15003250 15   Rice, flour                        0.100000   1.000  1.000

15003251 15   Rice, flour-babyfood               0.100000   1.000  1.000

15003260 15   Rice, bran                         0.100000   1.000  1.000

15003261 15   Rice, bran-babyfood                0.100000   1.000  1.000

06003470 6    Soybean, seed                      0.100000   1.000  1.000

06003480 6    Soybean, flour                     0.100000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.100000   1.000  1.000

06003490 6    Soybean, soy milk                  0.100000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.100000   1.000  1.000

06003500 6    Soybean, oil                       0.100000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.100000   1.000  1.000

95003590 O    Strawberry                         0.050000   1.000  1.000

95003591 O    Strawberry-babyfood                0.050000   1.000  1.000

95003600 O    Strawberry, juice                  0.050000   1.000  1.000

95003601 O    Strawberry, juice-babyfood         0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.003900   1.000  1.000

86020000 O    Water, indirect, all sources       0.003900   1.000  1.000

Chronic Food plus Water Results File – Acifluorfen – General Population

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ACIFLUORFEN                      (1994-98 data)

Residue file name: C:\Documents and Settings\colinger\My Documents\LACTOFEN\Chem\DEEMPRIA2006\AcifluorfenTier1ChronicFoodandWater genpop.R98                                             Adjustment factor #2 NOT used.

Analysis Date 11-07-2006/09:23:29     Residue file dated: 11-07-2006/09:22:39/8

Reference dose (RfD, Chronic) = .0013 mg/kg bw/day

COMMENT 1: Acifluorfen Tolerance and Water from Lactofen Applications - Water at 3.9 ppb

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000170                13.1%

U.S. Population (spring season)             0.000172                13.2%

U.S. Population (summer season)             0.000177                13.6%

U.S. Population (autumn season)             0.000165                12.7%

U.S. Population (winter season)             0.000167                12.8%

Northeast region                            0.000165                12.7%

Midwest region                              0.000166                12.7%

Southern region                             0.000159                12.2%

Western region                              0.000197                15.2%

Hispanics                                   0.000200                15.4%

Non-hispanic whites                         0.000158                12.1%

Non-hispanic blacks                         0.000168                12.9%

Non-hisp/non-white/non-black                0.000305                23.5%

All infants (< 1 year)                      0.000478                36.8%

Nursing infants                             0.000192                14.7%

Non-nursing infants                         0.000587                45.1%

Children 1-6  yrs                           0.000308                23.7%

Children 7-12 yrs                           0.000201                15.4%

Females 13-19 (not preg or nursing)         0.000128                 9.8%

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    10.8%

Females 13-50 yrs                           0.000151                11.6%

Females 13+ (preg/not nursing)              0.000172                13.3%

Females 13+ (nursing)                       0.000205                15.8%

Males 13-19 yrs                             0.000156                12.0%

Males 20+ yrs                               0.000150                11.5%

Seniors 55+                                 0.000133                10.2%

Children 1-2 yrs                            0.000324                24.9%

Children 3-5 yrs                            0.000310                23.9%

Children 6-12 yrs                           0.000211                16.2%

Youth 13-19 yrs                             0.000142                10.9%

Adults 20-49 yrs                            0.000151                11.6%

Adults 50+ yrs                              0.000135                10.4%

Females 13-49 yrs                           0.000143                11.0%

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

Lactofen	Dietary Exposure and Risk Assessment	DP Number: D333149

PC Code:  128888

________________________________________________________________________ ______________

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