  SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	November 2, 2007 

SUBJECT:	Ethalfluralin: Acute, Chronic Non-Cancer, and Chronic Cancer
Dietary Risk Assessments for the Section 3 Registration Actions for Dill
and Potato.

PC Code:		113101

Decision Number:	336469

DP Barcode Number:	D333868

REVIEWER:	Christina Swartz, Chemist

Registration Action Branch 2

		Health Effects Division (7509P)

THROUGH:	Susan Stanton

		Mohsen Sahafeyan

		Dietary Exposure Science Advisory Council

and

Richard A. Loranger, PhD, Branch Senior Scientist

Registration Action Branch 2

Health Effects Division (7509P)

TO:		S. Brothers

assessments were conducted using the Dietary Exposure Evaluation Model
(DEEM-FCID™, Version 2.14), which uses food consumption data from the
USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998.  The analyses were performed to support the Section
3 requests for the establishment of permanent tolerances for residues of
the herbicide ethalfluralin,
[N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)-benzena
mine], in dill and potato.

Acute Dietary Exposure Results and Characterization

An acute dietary endpoint (i.e., single dose endpoint) for risk
assessment was not identified in the toxicity database for the general
US population.  For females 13-49, the acute assessment was somewhat
refined with the use of anticipated residues for existing commodities. 
However, the risk estimate is considered conservative because
anticipated residues were only used for blended commodities, but
tolerance-level and proposed tolerance-level residues were used for all
others.  In addition, an assumption of 100% crop treated (100 %CT) was
used.  A modeled estimated drinking water concentration (EDWC) of 0.011
ppm was derived from surface water estimates, and was included directly
in the dietary analysis.  The acute dietary exposure of 0.00061
mg/kg/day ethalfluralin at the 95th percentile of exposure is equivalent
to <1 % of the acute population adjusted dose (aPAD) and is below
HED’s level of concern (LOC) for females 13-49 years.

Chronic Dietary Exposure Results and Characterization

The chronic non-cancer dietary analysis for ethalfluralin is a
conservative estimate of dietary exposure to ethalfluralin.  Although
some refinements were used (AR values for many existing commodities),
the use of existing (for some commodities) and proposed tolerance levels
and the assumption of 100% crop treated result in protective estimates
of chronic dietary exposure.  The risk estimate for chronic dietary
exposure to ethalfluralin for the U.S. population is 0.00006 mg/kg/day
and is equivalent to <1% of the cPAD, which is not of concern for
chronic dietary risk.  The exposure estimate for the most highly exposed
population subgroup, children 1 to 2 years, is 0.00013 mg/kg/day, and is
equivalent to <1% of the cPAD, which is also not of concern.

Cancer Dietary Exposure Results and Characterization

Ethalfluralin is classified as a possible human carcinogen with a cancer
potency factor (Q1*) of 8.9 x 10-2 (mg/kg/day)-1.  The ethalfluralin
chronic cancer dietary analysis was refined with anticipated residues
for soybean, watermelon and drinking water derived from monitoring data
generated by USDA’s Pesticide Data Program; the calculated limit of
detection (LOD) for potato commodities; the ARs used in the
acute/chronic dietary assessments (blended commodities); and either
proposed or existing tolerance-level values for the remaining
commodities.  No adjustments were made for the % of crop treated, i.e.,
100 %CT was assumed.  The risk estimate for chronic cancer dietary (food
+ water) exposure to ethalfluralin for the U.S. population yields a
cancer risk estimate of 2 x 10-6.  EPA generally considers cancer risks
of 10-6 or less to be below the level of concern.  The precision which
can be assumed for cancer risk estimates is best described by rounding
to the nearest integral order of magnitude on the log scale; for
example, risks falling between 3.16 x 10-7 and 3.16 x 10-6 are expressed
as 10-6.  Considering the precision with which cancer hazard can be
estimated and the rounding procedure described above, cancer risk should
generally not be assumed to exceed the benchmark level of concern of
10-6 until the calculated risk exceeds approximately 3 x 10-6.  Since
the calculated cancer risk for ethalfluralin falls below this level,
estimated cancer risk is considered to be below the level of concern.

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. 
The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.)
divided by the required UFs or safety factors (SFs).

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 (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 ethalfluralin was conducted
by J. Redden (7/29/02, DP Num: 283742).

II.	Residue Information

Current ethalfluralin tolerances, summarized in Table 1, are published
in 40 CFR 180.416.  Also summarized in Table 1 are the anticipated
residue (AR) values used in the current dietary exposure assessments;
the rationale for the AR values is explained in this section.  The
proposed tolerance of 0.05 ppm was used for dill and potato in the acute
and non-cancer chronic analyses; however, for the cancer analysis, the
calculated limit of detection (LOD) of 0.016 ppm was used for residues
in potatoes (DP Barcodes: D306146, D306147, D333867, J. R. Tomerlin,
9/4/07).



Table 1.  Ethalfluralin, Tolerances and Anticipated Residue Values Used
in the Dietary Analysis

Commodity	180.416 Tolerance

(ppm)	Anticipated Residue Value (Acute/Chronic, ppm)	Anticipated Residue
Value

(Cancer, ppm)

Bean, dry, seed	0.05	0.01	0.01

Canola, seed	0.05	0.05	0.05

Dill	--	0.05	0.05

Peanut	0.05	0.01	0.01

Pea, dry, seed	0.05	0.01	0.01

Potato	--	0.05	0.016

Safflower, seed	0.05	0.05	0.05

Soybean	0.05	0.01	0.0005

Sunflower, seed	0.05	0.01	0.01

Vegetable, cucurbit, group 9, Except watermelon	0.05	0.01	0.01

Watermelon	0.05	0.01	0.0055



The somewhat refined acute and chronic non-cancer dietary analyses for
ethalfluralin are conservative estimates of dietary exposure that used
AR values and an assumption of 100%CT.  According to the ethalfluralin
Registration Eligibility Decision Document (RED), residues from field
trials were below the LOD of 0.01 ppm for dry bean, the cucurbit
vegetable group, peanuts, dry peas, soybeans, and sunflower seed;
therefore, the acute and chronic non-cancer dietary risk assessment used
AR values equivalent to the LOD for these commodities, rather than the
tolerance-level value.  In the acute and chronic non-cancer dietary risk
assessments, tolerance level residues were assumed for all other food
commodities, including the proposed tolerances for residues in dill and
potato.

Processing studies in rapeseed, safflower and soybean have shown no
concentration in any processed fraction, including oil.  Therefore, the
processing factors in the DEEM residue input file were set to 1.0,
indicating no concentration.  Even though the potato processing study
was inadequate, chromatograms from the study were examined and no
ethalfluralin residues were seen in processed potato commodities. 
Therefore, no concentration was assumed in the dietary exposure
assessment, and the default processing factor of 6.5x for dried potatoes
was set to 1x.

For the cancer analysis, monitoring data from USDA’s Pesticide Data
Program (PDP) were used for soybeans and watermelon.  For soybean, a
total of 595 samples from 2003 contained no detectable residues, with a
½ LOD value of 0.0005 ppm.  For watermelon, 118 samples analyzed in
2005 contained no detectable residues, with a ½ LOD value of 0.0055
ppm.  For the proposed use on potatoes, the chromatograms included with
the field trials support using the calculated LOD of 0.016 ppm.

 Drinking Water Data

Based on laboratory studies, ethalfluralin is expected to dissipate by
binding to soil particles and then degrading both aerobically and
anaerobically.  There are no major degradates detected; in laboratory
studies, several minor degradates were identified, all of which retain
the trifluromethyl phenolic ring structure.  Freundlich Kads values
ranged from 12 to 97 ml/g and in the field ethalfluralin did not leach. 
Laboratory metabolism half-lives in soil were 46 days for aerobic
systems and 14 days for anaerobic systems.  Ethalfluralin does not
hydrolyze, but does photodegrade rapidly in water with a half-life of
approximately 6 hours.  The laboratory volatility study indicates this
is not a major route of dissipation.

Tier II drinking water assessments for surface water for ethalfluralin
were performed based on Index Reservoir settings.  The maximum
simulation, the 1-in-10 year peak value, used for acute dietary
exposure, was calculated for the use on canola using a maximum
application rate of 1.15 lb ai/A.  The estimated drinking water
concentration (EDWC) from this simulation was 11 ppb.  The maximum
simulation for chronic exposures, or the 1-in-10 probability yearly, was
calculated for the use on dill, with a maximum application rate of 1.5
lb ai/A.  The EDWC from this simulation was 0.4 ppb.  For cancer risk
assessment, the average of yearly means was estimated to be 0.2 ppb.  In
the dietary analyses, the peak value of 11 ppb was used for acute
dietary assessment; for chronic dietary assessment, the 1-in 10-year
average of 0.4 ppb was used.  These values were entered directly in to
the DEEM-FCID model (as ppm, or 0.011 and 0.0004 ppm) for water, direct
and indirect, all sources.

For ground water sources, the Tier I drinking water assessment predicted
maximum EDWCs of 0.02 ppb for both acute and chronic exposure for the
use on dill, with a maximum application rate of 1.5 lb ai/A.  The use of
surface water estimates for drinking water in the dietary analysis is
protective of potential residues in ground water.

For the cancer assessment, an anticipated residue value generated from
the USDA PDP drinking water monitoring data was used; there were no
residues detected in 1,253 samples analyzed from 2003 – 2005.  The ½
LOD value of 23 ppt (0.023 ppb) was used directly in the cancer dietary
assessment for water, direct and indirect, all sources.  These data were
considered to be appropriate to use for the cancer risk assessment for
the following reasons:  1) application rates for both existing and
proposed uses are similar; while peak drinking water estimates differ
slightly from one crop to another, EFED’s modeled drinking water
numbers for the average of yearly means did not differ significantly by
crop, supporting the use of existing monitoring data to cover potential
residues from the proposed uses; 2) the drinking water monitoring data
were collected from a variety of states which include potential
ethalfluralin use areas; 3) the lack of findings of detectable residues
is supported by the modeled estimates and by the fate properties of
ethalfluralin (e.g., 6-hour half-life for aqueous photolysis).

EM-FCID™ Program and Consumption Information

Ethalfluralin acute and chronic (non-cancer 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 toxicological reasons
explained in Section V, the females 13-49 years sub-group is the only
sub-group for which an acute analysis for ethalfluralin is appropriate.

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.

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.



V.	Toxicological Information

The doses and endpoints selected for dietary exposure and risk
assessment for ethafluralin are shown below in Table 2.  [Ethalfluralin
Human Health Risk Assessment for Proposed Uses on Dill and Potato, C.
Swartz, DP Barcode Nos. D323068 and D323069, (10/19/2007)].

Table 2.  Toxicological Doses and Endpoints for Ethalfluralin for Use in
Dietary Risk Assessments.

Exposure Scenario	Point of Departure	Uncertainty/

FQPA SFs	Population Adjusted Dose for Risk Assessment	Study and
Toxicological Effects



Acute Dietary (General Population, including Infants and Children)	A
single dose effect relevant to the general US population including
infants and children was not identified in the toxicity studies
conducted with ethalfluralin.

Acute Dietary

(Females 13-49 years of age)	NOAEL = 75 mg/kg/day	UFA = 10x

UFH = 10x

FQPA SF= 1x	aPAD = 0.75 mg/kg/day	Rabbit Dev. Toxicity Study

LOAEL = 150 mg/kg/day based on increased number of resorptions and
increased sternal and cranial variations

Chronic Dietary (All Populations)	NOAEL = 4 mg/kg/day	UFA = 10x

UFH =10x

FQPA SF= 1x	cPAD = 0.04 mg/kg/day	Dog, Chronic Oral Toxicity Study

LOAEL = 20 mg/kg/day based on altered red blood cell morphology and
urinary bilirubin

Cancer (oral, dermal, inhalation)	Q* = 8.9 x 10-2 (mg/kg/day)-1 based on
increased mammary gland fibro-adenomas & combined adenomas/fiboadenomas
in female rats	Rat 2-year chronic/carcinogenicity study



VI.	Results/Discussion 

CID™ analyses estimate the dietary exposure of the U.S. population and
various population subgroups.  Table 3 summarizes estimated acute
dietary exposure and risk for females 13-49 years; chronic non-cancer
risk 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; and cancer risk for the general U.S.
population only, per HED policy.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

Even though the acute dietary analysis for ethalfluralin uses
anticipated residues, it is a conservative estimate of dietary exposure.
 Because the food commodities that may be treated with ethalfluralin are
blended commodities, it is appropriate to use AR values in the
assessment.  Tolerance level residues were assumed for all other food
commodities.  One hundred percent of all crops were assumed to be
treated and to contain residues.  Estimated exposure for females 13-49
years was 0.000604 mg/kg/day, equivalent to <1% (0.08 %) of the aPAD,
well below the Agency’s level of concern for acute dietary risk.  The
results of the acute dietary risk assessment are summarized in Table 3.

Results of the Chronic Dietary (Food and Drinking Water) Non-Cancer and
Cancer Exposure Analyses

The chronic non-cancer dietary analysis for ethalfluralin is a
reasonable conservative estimate of dietary exposure that used AR values
and assumed 100% crop treated; the AR values are the same as used in the
acute dietary risk assessment.  The risk estimate of 0.000064 mg/kg/day
for chronic dietary exposure to ethalfluralin for the U.S. population is
equivalent to <1% of the cPAD, which is not of concern.  Similarly, the
exposure estimate of 0.000133 mg/kg/day for the most exposed population
subgroup, children 1 to 2 years, is <1% of the PAD, and is also not of
concern.

The cancer dietary analysis for ethalfluralin, although more refined
than the chronic non-cancer assessment, is also conservative because
100% CT was assumed.  The risk estimate for chronic cancer dietary
exposure (0.000022 mg/kg/day) to ethalfluralin for the U.S. population
yields a cancer risk estimate of 2 x 10-6.  EPA generally considers
cancer risks of 10-6 or less to be below the level of concern.  The
precision which can be assumed for cancer risk estimates is best
described by rounding to the nearest integral order of magnitude on the
log scale; for example, risks falling between 3.16 x 10-7 and 3.16 x
10-6 are expressed as 10-6.  Considering the precision with which cancer
hazard can be estimated and the rounding procedure described above,
cancer risk should generally not be assumed to exceed the benchmark
level of concern of 10-6 until the calculated risk exceeds approximately
3 x 10-6.  Since the calculated cancer risk for ethalfluralin falls
below this level, estimated cancer risk is considered to be below the
level of concern.

Table 3.  Summary of Dietary  Food plus Drinking Water Exposure and Risk
for Ethalfluralin

Population Subgroup	Acute Dietary

(95th 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	N/A	N/A	0.000064	0.2	0.000022	1.96 x 10-6

All Infants (< 1 year old)

	0.000099	0.2	N/A	N/A

Children 1-2 years old1

	0.000133	0.3



Children 3-5 years old

	0.000124	0.3



Children 6-12 years old

	0.000085	0.2



Youth 13-19 years old

	0.000063	0.2



Adults 20-49 years old

	0.000054	0.1



Adults 50+ years old

	0.000053	0.1



Females 13-49 years old	0.000604	0.08	0.000051	0.1



1Most highly exposed population sub-group is displayed in bold.

VII.	Characterization of Inputs/Outputs

The acute and chronic dietary risk assessments conducted for
ethalfluralin are considered somewhat refined because they use AR values
instead of tolerance values for some commodities to estimate the
residues in treated commodities.  However, the full LOD of 0.01 ppm was
used only for blended commodities, per HED policy.  The tolerance, or
proposed tolerance value in the case of dill and potato, of 0.05 ppm was
used for all non-blended commodities.  Therefore, the dietary risk
assessments provide reasonable worst case risk estimates, particularly
since risk assessments assumed residues in 100% of the commodities
(i.e., 100 % crop treated).  The chronic cancer dietary assessment is
more refined, but is still conservative because 100 %CT was assumed.

VIII.	Conclusions

The results of the acute and chronic dietary risk assessments
demonstrate estimated exposures are not of concern.  Therefore, the
requested uses for ethalfluralin on dill and potatoes are supported.



IX.		List of Attachments

Attachment 1 – Acute Residue Input File

Attachment 2 – Acute Dietary (Food Plus Water) Risk Assessment Results

Attachment 3 – Chronic Non-Cancer Dietary (Food Plus Water) Input File

Attachment 4 – Chronic Non-Cancer Dietary (Food Plus Water) Risk
Assessment Results

Attachment 5 – Chronic Cancer Dietary (Food Plus Water) Input File

Attachment 6 – Chronic Cancer Dietary (Food Plus Water) Risk
Assessment Results

Attachment 1 – Acute Dietary (Food Plus Water) Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for ETHALFLURALIN, 113101

Residue file name: C:\Documents and Settings\cswart02\My
Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin
dietary\Dill_Potato_2007_acute.R98

Analysis Date 09-28-2007             Residue file dated:
09-28-2007/13:37:57/8

Reference dose: aRfD = 0.75 mg/kg bw/day  NOEL = 75 mg/kg bw/day

Comment: Standard UFs of 100X apply.

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

09020210 9B   Balsam pear                        0.010000   1.000  1.000

06030300 6C   Bean, black, seed                  0.010000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.010000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.010000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.010000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.010000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.010000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.010000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.010000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.010000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.010000   1.000  1.000

09010750 9A   Cantaloupe                         0.010000   1.000  1.000

09010800 9A   Casaba                             0.010000   1.000  1.000

09020880 9B   Chayote, fruit                     0.010000   1.000  1.000

06030980 6C   Chickpea, seed                     0.010000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000  1.000

06030990 6C   Chickpea, flour                    0.010000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.010000   1.000  1.000

09021350 9B   Cucumber                           0.010000   1.000  1.000

19021430 19B  Dill, seed                         0.050000   1.000  1.000

19011440 19A  Dillweed                           0.050000   1.000  1.000

06031820 6C   Guar, seed                         0.010000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.010000   1.000  1.000

09011870 9A   Honeydew melon                     0.010000   1.000  1.000

06032030 6C   Lentil, seed                       0.010000   1.000  1.000

06032560 6C   Pea, dry                           0.010000   1.000  1.000

06032561 6C   Pea, dry-babyfood                  0.010000   1.000  1.000

06032580 6C   Pea, pigeon, seed                  0.010000   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

01032960 1C   Potato, chips                      0.050000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.050000   1.000  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   1.000  1.000

01032980 1C   Potato, flour                      0.050000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000

09023080 9B   Pumpkin                            0.010000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.010000   1.000  1.000

20003190 20   Rapeseed, oil                      0.050000   1.000  1.000

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000  1.000

20003300 20   Safflower, oil                     0.050000   1.000  1.000

20003301 20   Safflower, oil-babyfood            0.050000   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

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

20003640 20   Sunflower, seed                    0.010000   1.000  1.000

20003650 20   Sunflower, oil                     0.010000   1.000  1.000

20003651 20   Sunflower, oil-babyfood            0.010000   1.000  1.000

86010000 O    Water, direct, all sources         0.011000   1.000  1.000

86020000 O    Water, indirect, all sources       0.011000   1.000  1.000

09013990 9A   Watermelon                         0.010000   1.000  1.000

09014000 9A   Watermelon, juice                  0.010000   1.000  1.000

Attachment 2 – Acute Dietary (Food Plus Water) Risk Assessment
Results

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHALFLURALIN, 113101              
(1994-98 data)

Residue file: Dill_Potato_2007_acute.R98          Adjustment factor #2
NOT used.

Analysis Date: 09-28-2007/13:38:35    Residue file dated:
09-28-2007/13:37:57/8

NOEL (Acute) =  75.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Standard UFs of 100X apply."

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  %
aRfD     MOE  

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

Females 13-49 yrs:

  0.000604    0.08  124249    0.000931    0.12   80558    0.001644   
0.22   45630  

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHALFLURALIN, 113101              
(1994-98 data)

Residue file: Dill_Potato_2007_acute.R98          Adjustment factor #2
NOT used.

Analysis Date: 09-28-2007/13:38:35    Residue file dated:
09-28-2007/13:37:57/8

NOEL (Acute) =  75.000000 mg/kg body-wt/day

Acute Reference Dose (aRfD) =   0.750000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Standard UFs of 100X apply."

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

Females 13-49 yrs                  Daily Exposure Analysis  /a

-----------------                  (mg/kg body-weight/day) 

                                    per Capita    per User 

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

            Mean                      0.000259     0.000259

            Standard Deviation        0.000193     0.000193

            Standard Error of mean    0.000003     0.000003

            Margin of Exposure 2/      289,832      289,797

            Percent of aRfD               0.03         0.03

       Percent of Person-Days that are User-Days =  99.99%

  Estimated percentile of user-days falling below calculated exposure

    in mg/kg body-wt/day with Margin of Exposure (MOE) and Percent of
aRfD

Perc.   Exposure    % aRfD     MOE       Perc.  Exposure    % aRfD     
MOE

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

10.00     0.000072     0.01 >1,000,000   90.00    0.000485     0.06   
154,568

20.00     0.000112     0.01    671,414   95.00    0.000604     0.08   
124,243

30.00     0.000147     0.02    511,423   97.50    0.000734     0.10   
102,148

40.00     0.000183     0.02    409,933   99.00    0.000931     0.12    
80,556

50.00     0.000218     0.03    343,583   99.50    0.001120     0.15    
66,951

60.00     0.000258     0.03    291,040   99.75    0.001297     0.17    
57,846

70.00     0.000304     0.04    247,016   99.90    0.001644     0.22    
45,630

80.00     0.000376     0.05    199,552

  Estimated percentile of per-capita days falling below calculated
exposure

    in mg/kg body-wt/day with Margin of Exposure (MOE) and Percent of
aRfD

Perc.   Exposure    % aRfD     MOE       Perc.  Exposure    % aRfD     
MOE

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

10.00     0.000071     0.01 >1,000,000   90.00    0.000485     0.06   
154,573

20.00     0.000112     0.01    671,673   95.00    0.000604     0.08   
124,249

30.00     0.000147     0.02    511,506   97.50    0.000734     0.10   
102,150

40.00     0.000183     0.02    410,002   99.00    0.000931     0.12    
80,558

50.00     0.000218     0.03    343,617   99.50    0.001120     0.15    
66,952

60.00     0.000258     0.03    291,063   99.75    0.001297     0.17    
57,847

70.00     0.000304     0.04    247,033   99.90    0.001644     0.22    
45,630

80.00     0.000376     0.05    199,561

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

a/ Analysis based on all two-day participant records in CSFII 1994-98

   with 2 days of valid drinking water records.

2/ Margin of Exposure = NOEL/ Dietary Exposure

Attachment 3 – Chronic Non-Cancer Dietary (Food Plus Water) Input
File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101             
1994-98 data

Residue file: C:\Documents and Settings\cswart02\My
Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin
dietary\Dill_Potato_2007_chronic.R98

                                                           Adjust. #2
NOT used

Analysis Date 09-28-2007             Residue file dated:
09-28-2007/13:32:05/8

Reference dose (RfD) = 0.04 mg/kg bw/day

Comment:Standard UFs of 100X apply.

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

09020210 9B   Balsam pear                        0.010000   1.000     
1.000   

06030300 6C   Bean, black, seed                  0.010000   1.000     
1.000   

06030320 6C   Bean, broad, seed                  0.010000   1.000     
1.000   

06030340 6C   Bean, cowpea, seed                 0.010000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.010000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.010000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.010000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.010000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.010000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.010000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.010000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.010000   1.000     
1.000   

09010800 9A   Casaba                             0.010000   1.000     
1.000   

09020880 9B   Chayote, fruit                     0.010000   1.000     
1.000   

06030980 6C   Chickpea, seed                     0.010000   1.000     
1.000   

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000     
1.000   

06030990 6C   Chickpea, flour                    0.010000   1.000     
1.000   

09021020 9B   Chinese waxgourd                   0.010000   1.000     
1.000   

09021350 9B   Cucumber                           0.010000   1.000     
1.000   

19021430 19B  Dill, seed                         0.050000   1.000     
1.000   

19011440 19A  Dillweed                           0.050000   1.000     
1.000   

06031820 6C   Guar, seed                         0.010000   1.000     
1.000   

06031821 6C   Guar, seed-babyfood                0.010000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.010000   1.000     
1.000   

06032030 6C   Lentil, seed                       0.010000   1.000     
1.000   

06032560 6C   Pea, dry                           0.010000   1.000     
1.000   

06032561 6C   Pea, dry-babyfood                  0.010000   1.000     
1.000   

06032580 6C   Pea, pigeon, seed                  0.010000   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   

01032960 1C   Potato, chips                      0.050000   1.000     
1.000   

01032970 1C   Potato, dry (granules/ flakes)     0.050000   1.000     
1.000   

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   1.000     
1.000   

01032980 1C   Potato, flour                      0.050000   1.000     
1.000   

01032981 1C   Potato, flour-babyfood             0.050000   1.000     
1.000   

01032990 1C   Potato, tuber, w/peel              0.050000   1.000     
1.000   

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000     
1.000   

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000     
1.000   

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000     
1.000   

09023080 9B   Pumpkin                            0.010000   1.000     
1.000   

09023090 9B   Pumpkin, seed                      0.010000   1.000     
1.000   

20003190 20   Rapeseed, oil                      0.050000   1.000     
1.000   

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000     
1.000   

20003300 20   Safflower, oil                     0.050000   1.000     
1.000   

20003301 20   Safflower, oil-babyfood            0.050000   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   

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   

20003640 20   Sunflower, seed                    0.010000   1.000     
1.000   

20003650 20   Sunflower, oil                     0.010000   1.000     
1.000   

20003651 20   Sunflower, oil-babyfood            0.010000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.000400   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.000400   1.000     
1.000   

09013990 9A   Watermelon                         0.005500   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.005500   1.000     
1.000   

Attachment 4 – Chronic Non-Cancer Dietary (Food Plus Water) Risk
Assessment Results

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101            (1994-98
data)

Residue file name: C:\Documents and Settings\cswart02\My
Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin
dietary\Dill_Potato_2007_chronic.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 09-28-2007/13:39:31     Residue file dated:
09-28-2007/13:32:05/8

Reference dose (RfD, Chronic) = .04 mg/kg bw/day

COMMENT 1: Standard UFs of 100X apply.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000064                
0.2%

U.S. Population (spring season)             0.000064                
0.2%

U.S. Population (summer season)             0.000066                
0.2%

U.S. Population (autumn season)             0.000064                
0.2%

U.S. Population (winter season)             0.000063                
0.2%

Northeast region                            0.000058                
0.1%

Midwest region                              0.000070                
0.2%

Southern region                             0.000064                
0.2%

Western region                              0.000064                
0.2%

Hispanics                                   0.000070                
0.2%

Non-hispanic whites                         0.000064                
0.2%

Non-hispanic blacks                         0.000059                
0.1%

Non-hisp/non-white/non-black                0.000069                
0.2%

All infants (< 1 year)                      0.000099                
0.2%

Nursing infants                             0.000037                
0.1%

Non-nursing infants                         0.000123                
0.3%

Children 1-6  yrs                           0.000124                
0.3%

Children 7-12 yrs                           0.000082                
0.2%

Females 13-19 (not preg or nursing)         0.000056                
0.1%

Females 20+ (not preg or nursing)           0.000050                
0.1%

Females 13-50 yrs                           0.000054                
0.1%

Females 13+ (preg/not nursing)              0.000052                
0.1%

Females 13+ (nursing)                       0.000061                
0.2%

Males 13-19 yrs                             0.000070                
0.2%

Males 20+ yrs                               0.000057                
0.1%

Seniors 55+                                 0.000053                
0.1%

Children 1-2 yrs                            0.000133                
0.3%

Children 3-5 yrs                            0.000124                
0.3%

Children 6-12 yrs                           0.000085                
0.2%

Youth 13-19 yrs                             0.000063                
0.2%

Adults 20-49 yrs                            0.000054                
0.1%

Adults 50+ yrs                              0.000053                
0.1%

Females 13-49 yrs                           0.000051                
0.1%

Attachment 5 – Chronic Cancer Dietary (Food Plus Water) Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101             
1994-98 data

Residue file: C:\Documents and Settings\cswart02\My
Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin
dietary\Dill_Potato_2007_cancer.R98

                                                           Adjust. #2
NOT used

Analysis Date 09-28-2007             Residue file dated:
09-28-2007/13:37:33/8

Q* = 0.089

Comment:Standard UFs of 100X apply.

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

09020210 9B   Balsam pear                        0.010000   1.000     
1.000   

06030300 6C   Bean, black, seed                  0.010000   1.000     
1.000   

06030320 6C   Bean, broad, seed                  0.010000   1.000     
1.000   

06030340 6C   Bean, cowpea, seed                 0.010000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.010000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.010000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.010000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.010000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.010000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.010000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.010000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.010000   1.000     
1.000   

09010800 9A   Casaba                             0.010000   1.000     
1.000   

09020880 9B   Chayote, fruit                     0.010000   1.000     
1.000   

06030980 6C   Chickpea, seed                     0.010000   1.000     
1.000   

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000     
1.000   

06030990 6C   Chickpea, flour                    0.010000   1.000     
1.000   

09021020 9B   Chinese waxgourd                   0.010000   1.000     
1.000   

09021350 9B   Cucumber                           0.010000   1.000     
1.000   

19021430 19B  Dill, seed                         0.050000   1.000     
1.000   

19011440 19A  Dillweed                           0.050000   1.000     
1.000   

06031820 6C   Guar, seed                         0.010000   1.000     
1.000   

06031821 6C   Guar, seed-babyfood                0.010000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.010000   1.000     
1.000   

06032030 6C   Lentil, seed                       0.010000   1.000     
1.000   

06032560 6C   Pea, dry                           0.010000   1.000     
1.000   

06032561 6C   Pea, dry-babyfood                  0.010000   1.000     
1.000   

06032580 6C   Pea, pigeon, seed                  0.010000   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   

01032960 1C   Potato, chips                      0.016000   1.000     
1.000   

01032970 1C   Potato, dry (granules/ flakes)     0.016000   1.000     
1.000   

01032971 1C   Potato, dry (granules/ flakes)-b   0.016000   1.000     
1.000   

01032980 1C   Potato, flour                      0.016000   1.000     
1.000   

01032981 1C   Potato, flour-babyfood             0.016000   1.000     
1.000   

01032990 1C   Potato, tuber, w/peel              0.016000   1.000     
1.000   

01032991 1C   Potato, tuber, w/peel-babyfood     0.016000   1.000     
1.000   

01033000 1C   Potato, tuber, w/o peel            0.016000   1.000     
1.000   

01033001 1C   Potato, tuber, w/o peel-babyfood   0.016000   1.000     
1.000   

09023080 9B   Pumpkin                            0.010000   1.000     
1.000   

09023090 9B   Pumpkin, seed                      0.010000   1.000     
1.000   

20003190 20   Rapeseed, oil                      0.050000   1.000     
1.000   

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000     
1.000   

20003300 20   Safflower, oil                     0.050000   1.000     
1.000   

20003301 20   Safflower, oil-babyfood            0.050000   1.000     
1.000   

06003470 6    Soybean, seed                      0.000500   1.000     
1.000   

06003480 6    Soybean, flour                     0.000500   1.000     
1.000   

06003481 6    Soybean, flour-babyfood            0.000500   1.000     
1.000   

06003490 6    Soybean, soy milk                  0.000500   1.000     
1.000   

06003491 6    Soybean, soy milk-babyfood or in   0.000500   1.000     
1.000   

06003500 6    Soybean, oil                       0.000500   1.000     
1.000   

06003501 6    Soybean, oil-babyfood              0.000500   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   

20003640 20   Sunflower, seed                    0.010000   1.000     
1.000   

20003650 20   Sunflower, oil                     0.010000   1.000     
1.000   

20003651 20   Sunflower, oil-babyfood            0.010000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.000023   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.000023   1.000     
1.000   

09013990 9A   Watermelon                         0.005500   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.005500   1.000     
1.000   

Attachment 6 – Chronic Cancer Dietary (Food Plus Water) Risk
Assessment Results

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101            (1994-98
data)

Residue file name: C:\Documents and Settings\cswart02\My
Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin
dietary\Dill_Potato_2007_cancer.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 09-28-2007/13:40:06     Residue file dated:
09-28-2007/13:37:33/8

Q* = 0.089 

COMMENT 1: Standard UFs of 100X apply.

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

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                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .089)

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

U.S. Population (total)                     0.000022         1.94E-06

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

Ethalfluralin	Dietary Exposure and Risk Assessment	DP Number: 333868	

PC Code:  113101

________________________________________________________________________
______________

 PAGE   

Page   PAGE  1  of   NUMPAGES  19 

 

