Document ID: EPA-HQ-OPP-2009-0980-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-02-02T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF CHEMICAL SAFETY AND

                                                                        
                      			POLLUTION PREVENTION 

MEMORANDUM

DATE:  	August 9, 2010

SUBJECT:	Fluazifop-p- Butyl Acute and Chronic Aggregate Dietary (Food
and Drinking Water) Exposure and Risk Assessment for the Section 3
Registration Action to add uses on Banana, Plantains, Citrus, Grapes,
Potato and Sugar beet. 

PC Code:  122809	DP Barcode:   D379452

Decision No.: 421332	Registration No.: 100-1070

Petition No.: 7F7289	Regulatory Action: Amended Section 3

Risk Assessment Type: Dietary Exposure	Case No.: 2285

TXR No.: NA	CAS No.: 79241-46-6

MRID No.: 	40 CFR:180.411

REVIEWER:	Seyed Tadayon, Chemist

Risk Assessment Branch V

Health Effects Division (7509P)

THROUGH:	Thurston Morton, Chemist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

TO:		Pete Savoia, Risk Assessor

Risk Assessment Branch V

Health Effects Division (7509P)

Executive Summary

Acute and chronic dietary risk assessments for fluazifop-p-butyl were
conducted using the Dietary Exposure Evaluation Model DEEM-FCID(,
Version 2.03,  which uses food consumption data from the USDA’s
Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996
and 1998.  The analysis was performed to support newly proposed Section
3 registrations on banana, plantains, citrus, grapes, potato and sugar
beet.  

An acute dietary (food and drinking water) exposure assessment was
conducted for all established and proposed uses of fluazifop-p-butyl. 
Acute anticipated residues for all commodities were derived from
tolerance level residues, and a ratio adjustment for additional
metabolites of concern.  Estimated and default processing factors along
with percent crop treated (100%CT) were also used as available. 
Estimated drinking water concentrations (EDWCs) from the Environmental
Fate and Effects Division (EFED) were also included.  Surface drinking
water concentrations were estimated using the PRZM/EXAMS computer model
with the Index Reservoir and Percent Crop Area.  The model predicts that
the maximum concentration of total residues of fluazifop-p-butyl in
surface water is not likely to exceed 33.4 ppb from the use of an aerial
application to banana and plantains.  Dietary risk estimates are
provided for the only population subgroup with an acute dietary
endpoint, females 13-49 years of age (13% aPAD).  No acute dietary end
point attributable to a single dose was identified for general
population including infants and children. This assessment concludes
that for all supported registered commodities and new uses, the acute
food plus water dietary risk estimates are below the Agency’s level of
concern (<100 % aPAD). 

A refined chronic dietary exposure analyses was also performed in order
to determine the chronic exposure and risks that result from the
registered uses and proposed uses of fluazifop-p-butyl.  Mean residue
level from crop field trials with a ratio adjustment for additional
metabolites of concern, percent crop treated estimates, and
experimentally determined processing factors were used in these
assessments (where available; otherwise default processing factors were
used).  A point estimate was used to assess the dietary exposure and
risk resulting from fluazifop-p-butyl residues in water. Drinking water
was represented by a single point estimate of average fluazifop-p-butyl
residues.  The estimated surface water concentration of 6.6 ppb was
based on the one in ten year annual mean from the grape application
rate.  Dietary risk estimates are provided for the U.S. population
(total) and various population subgroups.  This assessment also
concludes that for all commodities, the chronic food plus water dietary
risk estimates are below the Agency’s level of concern (<100 %cPAD)
for the U.S. population (12% cPAD) and all population subgroups.  The
most highly exposed population subgroup in the chronic dietary exposure
analysis is children 1-2 years of age (40% cPAD).  

Fluazifop-p-butyl is classified as a “not likely to be carcinogenic to
humans;” therefore, no dietary cancer assessment was performed.

I.	Introduction

	Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and chronic assessments, the risk is
expressed as a percentage of a maximum acceptable dose (i.e., the dose
which HED has concluded will result in no unreasonable adverse health
effects).  This dose is referred to as the population adjusted dose
(PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL,
e.g.) divided by the required uncertainty or safety factors.

	For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD.  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:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf.

	The most recent dietary assessment for fluazifop-p-butyl was conducted
by S. Tadayon, D 3562009, 9/16/ 2008.

II.	Residue Information

	Fluazifop-p-butyl is the resolved isomer (R enantiomer) of
fluazifop-butyl
[(R,S)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic
acid, butyl ester].  The fluazifop-butyl isomers are List B chemicals. 
Fluazifop-butyl (PC code 122805) has been canceled and only
fluazifop-p-butyl is being supported for reregistration.

	Fluazifop-p-butyl
[(R)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid,
butyl ester] is a selective herbicide registered for use for
postemergence control of perennial and annual grass weeds. 
Fluazifop-p-butyl is currently registered for food/feed use on
asparagus, carrot, coffee, cotton, endive (escarole), garlic, macadamia
nut, onion (bulb), pecan, pepper, rhubarb, soybean, stone fruit, sweet
potato, dry beans, peanuts, soybeans and yam (DP Barcode: 298939, S.
Kinard, 6/22/04 and DP Barcode 3562009, S.Tadayon, 9/16/2008 ).

Fluazifop-p-butyl Use

	Fluazifop-p-butyl products are registered in the U.S. to Syngenta Crop
Protection, Inc. Currently, the 0.086, 0.47, 1, 2, and 4 lb/gal
emulsifiable concentrate (EC) formulations of fluazifop-p-butyl are
registered for use on food/feed crops.  The products are typically
applied as postemergence foliar or soil applications using ground or
aerial equipment; preplant, at-planting and/or postharvest applications
(to the plant) are also registered for some crops.

	The nature of the residue in plants and livestock is not adequately
understood; additional plant metabolism studies with a root crop and a
leafy vegetable, as well as ruminant and poultry metabolism studies must
be submitted.  In a meeting on March 3, 2004, the Metabolism Assessment
Review Committee (MARC) recommended that for tolerance expression (both
plants and animals), risk assessment of livestock commodities, and
drinking water, the residues of concern are parent and fluazifop-acid
(free and conjugated). However, the MARC also recommended that for risk
assessment, the residues of concern are parent, fluazifop-acid (free and
conjugated), 5-trifluoromethyl-2-pyridone, and 2-(4-hydroxyphenoxy)
propionic acid (free and conjugated) (DP Barcode: 298939, S. Kinard,
6/22/04).

Residue Data used for Acute and Chronic Assessments

	For acute dietary exposure assessment, tolerance level residues with a
ratio adjustment for additional metabolites of concern, 100 % crop
treated (CT), and default processing factors were used. For chronic
dietary exposure assessment, %CT estimates from BEAD (memo dated May 27,
2010 by A. Grube) and average value from field trials with a ratio
adjustment were utilized.  Default processing factor and measured
processing factor (potato) were also used in chronic assessment.  

	The analytical protocol can not detect the additional residues
resulting from all metabolites. To account for all additional
metabolites of concern for non-cancer risk identified by the MARC
(parent, fluazifop-acid plus 5-trifluoromethyl-2-pyridone, and
2-(4-hydroxyphenoxy) propionic acid), data from the fluazifop carrot
(MRID No. 00152494), celery (MRID No. 40693102), and soybean (MRID Nos.
41994701-41994703) metabolism studies were used to derive residue
adjustment factors by dividing residues of the pyridone plus the
propionic acid by residues of parent and fluazifop-acid.  Adjustment
factors ranged from 0.12 xs  to 0.9 xs. These adjustment factors were
multiplied by the tolerance level or average field trial residues
(parent plus fluazifop acid), to derive estimates of non-measured
metabolite residues.  The derived values and tolerance level residues
were added together to reflect the total residue of concern (parent and
fluazifop acid plus the pyridone plus the propionic acid).  The ratios
and estimates used in these assessments are listed in the tables 1 and
2.

Table 1.  Metabolite Ratios

Residue	Carrot roots*	Celery stems	Celery leaves	Soybean

	%TRR	ppm	%TRR	ppm	%TRR	ppm	%TRR	ppm

fluazifop plus fluazifop acid	33.75	0.0885	39.6	0.032	62.7	0.401	28	3.1

5-trifluoromethyl-2-pyridone	1.0	0.003	2.8	0.003	9.6	0.061	–	--

2-(4-hydroxyphenoxy) propionic acid	5.6	0.019	1.1	0.001	0.3	0.002	25.5
2.8

Ratio used in the assessment	0.25X	0.12X	0.16X	0.9X

eg calculation (0.003 + 0.019)/0.0885=0.25X

(0.25X)(Tolerance)+Tolerance=AR

For the purpose of this petition only, the available soybean metabolism
study and derived metabolite ratio will support the new uses on banana,
plantains, citrus, grapes, potato and sugar beet.  The soybean ratio of
0.9x used for the new uses.  The resulting dietary assessment is very
conservative.    

Field Trials

Adequate field trial data depicting fluazifop-p-butyl residues following
applications made according to the maximum or proposed use patterns have
been submitted for various crops. A summary of submitted field trial
data are presented below:

Apricot

Apricot translated from peach and 100% CT assumed.   Peach field trial
data were used for apricot from MRID 92068039.  There were 4 residue
values.  An average fluazifop-p-butyl residue point estimate of 0.015
ppm and an adjustment factor of 1.9 were used for the chronic analysis
for all food forms.

Asparagus

BEAD estimates average % crop treated (CT) and maximum % CT of 2.5% and
5% CT for asparagus.  Field trial data were used for asparagus from MRID
92068023. There were 8 residue values for asparagus.  An average
fluazifop-p-butyl residue point estimate of 0.57 ppm and an adjustment
factor of 1.12 (0.64 ppm) were used for the chronic analysis for all
food forms. To account for % crop treated factor 2 was set to 0.025.

Cherry

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and
2.5% CT for cherry.  Field trial data were used for cherry from MRID
92068038. There were 5 residue values for cherry.  An average
fluazifop-p-butyl residue point estimate of 0.015 ppm and an adjustment
factor of 1.9 (0.029 pm) were used for the chronic analysis for all food
forms. To account for % crop treated factor 2 was set to 0.01.

Dry Beans

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and
2.5% CT for dry beans.  Field trial data were used for dry beans from
MRID 47285501. There were 24 residue values for dry beans.  An average
fluazifop-p-butyl residue point estimate of 5.4 ppm and an adjustment
factor of 1.9 (10.26 ppm) were used for the chronic analysis for all
food forms. To account for % crop treated factor 2 was set to 0.01.

Endive

Field trial data were used for endive from MRID 92068027.  There were 4
residue values for endive.  An average fluazifop-p-butyl residue point
estimate of 0.005 ppm and an adjustment factor of 1.16 were used for the
chronic analysis for all food forms.

Macadamia Nut

Field trial data were used for macadamia nut from MRID 92068037.  There
were 8 residue values for macadamia nut.  An average fluazifop-p-butyl
residue point estimate of 0.05 ppm and an adjustment factor of 1.9 were
used for the chronic analysis for all food forms.

Peach

BEAD estimates average % crop treated (CT) and maximum % CT of 2.5 and
10.0% CT for peach.  Field trial data were used for peach from MRID
92068039. There were 4 residue values for peach.  An average
fluazifop-p-butyl residue point estimate of 0.015 ppm and an adjustment
factor of 1.9 (0.029 ppm) were used for the chronic analysis for all
food forms. To account for % crop treated factor 2 was set to 0.025.

Peanut

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and
2.5% CT for peanut.  Field trial data were used for peanut from MRID
47285503. There were 21 residue values for peanut.  An average
fluazifop-p-butyl residue point estimate of 0.40 ppm and an adjustment
factor of 1.9 (0.76 ppm) were used for the chronic analysis for all food
forms. To account for % crop treated factor 2 was set to 0.01.

Peppers

BEAD estimates average % crop treated (CT) and maximum % CT of 1% and
2.5% CT for peppers.  Field trial data were used for pepper from MRID
92068031. There were 4 residue values for pepper.  An average
fluazifop-p-butyl residue point estimate of 0.06 ppm and an adjustment
factor of 1.12 (0.67 ppm) were used for the chronic analysis for all
food forms.  To account for % crop treated factor 2 was set to 0.01.

Plum

Field trial data were used for plum from MRID 92068034.  There were 8
residue values for plum.  An average fluazifop-p-butyl residue point
estimate of 0.01 ppm and an adjustment factor of 1.9 (0.19 ppm) were
used for the chronic analysis for all food forms. To account for % crop
treated factor 2 was set to 0.01.

Rhubarb

Field trial data were used for rhubarb from MRID 92068032.  There were 8
residue values for rhubarb.  An average fluazifop-p-butyl residue point
estimate of 0.19 ppm and an adjustment factor of 1.12 were used for the
chronic analysis for all food forms.

Citrus

Field trial data were used for citrus from MRID 47874602.  There were 17
residue values for citrus.  An average fluazifop-p-butyl residue point
estimate of 0.05 ppm and an adjustment factor of 1.9 were used for the
chronic analysis for all food forms.

Carrot

BEAD estimates average % crop treated (CT) and maximum % CT of 10% and
20% CT for carrot.  Field trial data were used for carrot from MRID
92068024. There were 12 residue values for carrot.  An average
fluazifop-p-butyl residue point estimate of 0.03 ppm and an adjustment
factor of 1.125 (0.038) were used for the chronic analysis for all food
forms. To account for % crop treated factor 2 was set to 0.10.

Onion

BEAD estimates average % crop treated (CT) and maximum % CT of 15% and
25% CT for onion.  Field trial data were used for onion from MRID#s
92068028, 92068029. There were 19 residue values for onion.  An average
fluazifop-p-butyl residue point estimate of 0.03 and an adjustment
factor of 1.125 (0.038) were used for the chronic analysis for all food
forms. To account for % crop treated factor 2 was set to 0.15

Garlic 

BEAD estimates average % crop treated (CT) and maximum % CT of 5% and
10% CT for onion.  Field trial data were translated from onion from
MRID#s 92068028, 92068029. There were 19 residue values for onion.  An
average fluazifop-p-butyl residue point estimate of 0.03 and an
adjustment factor of 1.125 (0.038) were used for the chronic analysis
for all food forms. To account for % crop treated factor 2 was set to
0.05.

Grapes

Field trial data were used for grape from MRID 47874604.  There were 12
residue values for grape.  An average fluazifop-p-butyl residue point
estimate of 0.005 ppm and an adjustment factor of 1.9 were used for the
chronic analysis for all food forms.

Potato

Field trial data were used for potato from MRID 47920402.  There were 26
residue values for potato.  An average fluazifop-p-butyl residue point
estimate of 0.11 ppm and an adjustment factor of 1.25 were used for the
chronic analysis for all food forms.

Soybeans

Field trial data were used for soybeans from MRID 92067046.  There were
34 residue values for soybeans.  An average fluazifop-p-butyl residue
point estimate of 1.0 ppm and an adjustment factor of 1.9 (1.9) were
used for the chronic analysis for all food forms. To account for % crop
treated factor 2 was set to 0.025.

Sugar beet

Field trial data were used for sugar beet from MRID 47874603.  There
were 24 residue values soybeans.  An average fluazifop-p-butyl residue
point estimate of 0.08 ppm and an adjustment factor of 1.9 were used for
the chronic analysis for all food forms.

Table 2.  Residue Estimates Used in Dietary Analyses

RAC	Food

Forms	%CT

(Acute)	%CT

(chronic)	Processing

Factors	Tolerance

	Average Residue (Field Trials)	Ratio

Apricot	all except dried	100	100	1	0.05	0.015	0.9 x1

	dried

	6

	Asparagus	all	100	2.5	1	3.0	0.57	0.12x2

Banana (New Use)	all	100	100	1	0.01	0.01	0.9 x1

Beef	all except dried	100	100	1	0.05	0.05	NA

	dried	100

1.92

	Carrot	all	100	10	1	2.0	0.03	0.25x4

1.5 juice

	Cherry	all	100	1.0	1	0.05	0.015	0.9x1

Chicken	all	100	100	1	0.05	0.05	NA

Citrus (New Use)	all	100	100	1	0.05	0.05	0.9x1

Coffee	all	100	100	1	0.10	0.10	0.9x1

Cottonseed	all	100	2.5	1	0.20	0.20	0.9x1

Dry Beans	all	100	1.0	1	50 	5.4	0.9x1

Egg	all	100	100	1	0.05	0.05	NA

Endive	all	100	100	1	6.0	0.05	0.16x3

Grapes (New Use)	all	100	100

0.01	0.005	0.9x1

Goat	all	100	100	1	0.05	0.05	NA

Garlic	all except dried	100	5	1	0.50	0.03	0.25x4

	dried

Horsemeat	all	100	100	1	0.05	0.05	NA

Macadamia Nut	all	100	100	1	0.10	0.05	0.9x

Milk	all	100	100	1	0.05	0.05	NA

Nectarine	all	100	100	1	0.05	0.05	0.9x1

Onion (bulb)	all except dried	100	15	1	0.50	0.03	0.25x4

	dried	100

9

	

Peach	all except dried	100	2.5	1	0.05	0.015	0.9x1

	dried	100

7

	Pecan	all	100	100	1	0.05	0.05	0.9x1

Peanut	all	100	1	1	1.5	0.38	0.9x1

Peanut oil

0.01

	Peanut butter

1.89

	Pepper (non-bell)	all	100	1	1	1.0	0.6	0.12x2

Plantain (New Use)	all	100	100	1	0.01	0.01	0.9x1

Plum	all except dried and juice	100	100	1	0.05	0.01	0.9x1

	dried	100

5

Prune, juice	100

1.4

	Pork	all	100	100	1	0.05	0.05	NA

Poultry	all	100	100	1	0.05	0.05	NA

Potato (New Use)	all	100	100	1.4 cooked	1	0.11	0.25x4

3.3 chips

	6.4 dried

	Rhubarb	all	100	100	1	0.50	0.19	0.12x2

Sheep	all	100	100	1	0.05	0.05	NA

Soybean	all except oil	100	100	1	2.5 	1.0	0.9x1

Soybean, oil	oil	100	100	0.01	2.0	2.0	0.9x1

Spinach	all	100	100	1	6	0.05	0.16x3

Sugar Beet (New Use)	Root	100	100	1	0.25	0.08	0.9x1

	Top

100	1	1.50	008	0.9x1

	Dried Pulp

100	1	1	0.08	0.9x1

	Molasses

100	1	3.5	0.08	0.9x1

Sweet potato	all	100	10	1	1.0	0.11	0.25x4

Turkey	all	100	100	1	0.05	0.05	NA

Water	all direct and indirect sources	100	100	1	0.0334 (acute)

0.0066 (chronic)

NA

Yam	all	100	100	1	1.0	0.11	0.25x4

1		Soybean metabolism study.

2		Celery metabolism study (stalks).

3		Celery metabolism study (leaves).

4		Carrot metabolism study (roots).

 

III 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: “Revised Drinking Water Assessment for the
Section 3 Registration of Fluazifop-p-butyl For Use on bananas,
plantains, citrus, grapes, and sugar beets pre-bloom and post-bloom (Wm.
J. Shaughnessy, D371093, 05/25/2010) and incorporated directly into this
dietary assessment.  Water residues were incorporated in the DEEM-FCID
into the food categories “water, direct, all sources” and “water,
indirect, all sources.”   

Estimated exposure concentrations (EECs) in ground water were modeled
using Tier I SCIGROW (version 2.3, dated July 29, 2003) and surface
water EECs were modeled using Tier II PRZM (Pesticide Root Zone Model;
vers. 3.12.2, May 12, 2005) and EXAMS (Exposure Analysis Modeling
System; Vers. 2.98.04.06).  The results of this analysis are presented
in   REF _Ref201544974 \h  \* MERGEFORMAT  Table 3 .  Estimated exposure
concentrations represent exposure to fluazifop-acid, with assumptions
that fluazifop-acid may be present in the R or S form or as a mixture of
the enantiomers.  

The results of current assessment are higher than 2008 assessment (DP
No. D347521, K. White, 08/04/2008).  For aerial applications the highest
surface water EECs reported for peak, 1 in 10 year average, and the 30
year average as estimated by PRZM/EXAMS for all crop use scenarios were
33.4, 6.6 ppb, and 4.4 ppb, respectively.  For ground applications the
highest EECs for peak, 1 in 10 year average, and the 30 year average
were 32.1 ppb, 5.8 ppb, and 3.1 ppb, respectively.  SCI-GROW estimated
the concentration of fluazifop-acid in shallow ground water sources to
be 1.56 ppb.  The difference between the 2008 and current assessment
results can be attributed to a proposed increase in the maximum number
of allowable applications (i.e., 3 vs. 2), and differences in crop use
scenarios used in the two assessments.

g/L)

	Acute or Peak	1 in 10 year Average (Noncancer Chronic)	30 year Average
(Cancer Chronic) 

Aerial Applications 	Surface Water

Bananas & Plantains	33.4	6.2	3.2

Citrus	28.5	5.4	3.7

Grapes	19.8	6.6	4.4

Sugar Beets

	Ground Applications	Surface Water

Bananas & Plantains	32.1	5.8	2.7

Citrus	27.3	5.1	2.8

Grapes	16.6	5.3	3.1

Sugar Beets	10.6	3.9	2.3

All Uses	Ground Water

	1.56	1.56	1.56

IV DEEM-FCID( Program and Consumption Information

	Fluazifop-p-butyl acute and chronic dietary exposure assessments were
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID(, Version 2.03), which
incorporates consumption data from USDA’s Continuing Surveys of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98
data are based on the reported consumption of more than 20,000
individuals over two non-consecutive survey days.  Foods “as
consumed” (e.g., apple pie) are linked to EPA-defined food commodities
(e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour
- cooked; fresh or N/S, baked) using publicly available recipe
translation files developed jointly by USDA/ARS and EPA.  For chronic
exposure assessment, consumption data are averaged for the entire U.S.
population and within population subgroups, but for acute exposure
assessment are retained as individual consumption events.  Based on
analysis of the 1994-96, 98 CSFII consumption data, which took into
account dietary patterns and survey respondents, HED concluded that it
is most appropriate to report risk for the following population
subgroups: the general U.S. population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49,
females 13-49, and adults 50+ years old.

	For chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate.  The resulting residue intake estimate for each food/food form
is summed with the residue intake estimates for all other food/food
forms on the commodity residue list to arrive at the total average
estimated exposure.  Exposure is expressed in mg/kg body weight/day and
as a percent of the cPAD.  This procedure is performed for each
population subgroup.

	For acute exposure assessments, individual one-day food consumption
data are used on an individual-by-individual basis.  The reported
consumption amounts of each food item can be multiplied by a residue
point estimate and summed to obtain a total daily pesticide exposure for
a deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis.  In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis.  However, for 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 May 6, 2004, the Health Effects Division (HED) Hazard Identification
Assessment Review Committee (HIARC) reviewed the recommendations of the
toxicology reviewer for Fluazifop-butyl and Fluazifop-p-butyl with
regard to the acute and chronic Reference Doses (RfDs) and the
toxicological endpoint selection for use as appropriate in
occupational/residential exposure risk assessments.  The potential for
increased susceptibility of infants and children from exposure to
Fluazifop-butyl and Fluazifop-p-butyl was also evaluated as required by
the Food Quality Protection Act (FQPA) of 1996 (TXR NO.  0052611; memo
dated June 15, 2004 by D. Anderson).  The conclusions drawn at this
meeting are presented in Table 4 below.

Table 4.  Summary of Toxicological Doses and Endpoints for
Fluazifop-p-butyl 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 population including infants and children)	

An appropriate endpoint attributable to a single dose was not identified
in the available studies including the developmental toxicity studies.

Acute Dietary

(Females 13-49 years of age)	

NOAEL = 50 mg/kg/day

UF = 100

Acute RfD = 0.50 mg/kg	

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

 = 0.50  mg/kg/day	

Developmental Toxicity in rats.

LOAEL = 200 mg/kg/day based on diaphragmatic hernia.

Chronic Dietary

(All populations)	

NOAEL= 0.74  mg/kg/day

UF = 100

Chronic RfD = 

0.008 mg/kg/day	

FQPA SF = 1X

cPAD = chronic RfD

               FQPA SF

= 0.0074 mg/kg/day	

Two-Generation Reproduction in rats.

LOAEL = 5.8 mg/kg/day in males and 7.1 in females based on decreased
spleen, testes & epididymal weights in males and uterine & pituitary
weights in females.

Cancer	

“Not likely to be carcinogenic to humans.”

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 Tables 5 and 6 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

	

	Dietary risk estimates are presented for the only population subgroup
with an acute dietary endpoint, females 13-49 years of age (13 % aPAD at
95.0th percentile).  No acute dietary end point attributable to a single
dose was identified for general population including infants and
children. This assessment concludes that for all supported registered
commodities and new uses, the acute food plus water dietary risk
estimates are below the Agency’s level of concern (<100 % aPAD).This
assessment is considered to be conservative.  The results are listed
below in Table 5.

Table 5.  Summary of Acute Dietary (Food + Drinking Water) Exposure and
Risk for Fluazifop-p-butyl 

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

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

Female 13-49 years old	0.5	0.0641	13	0.1515	30	0.3673	74

Results of Chronic Dietary Exposure Analysis

This assessment concludes that for all commodities, the chronic food
plus water dietary risk estimates are below the Agency’s level of
concern (<100 %cPAD) for the U.S. population (12% cPAD) and all
population subgroups.  The most highly exposed population subgroup in
the chronic dietary exposure analysis is children 1-2 years of age (40%
cPAD). This assessment is still considered to be fairly conservative
since mean residue estimates were used.  Results for all populations
considered are listed below in Table 6.

Table6.  Summary of Chronic Dietary (Food + Drinking Water) Exposure and
Risk for Fluazifop-p-butyl.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.0074	0.0009	12

All Infants (< 1 year old)

0.0015	20

Children 1-2 years old

0.003	40

Children 3-5 years old

0.0022	30

Children 6-12 years old

0.0014	19

Youth 13-19 years old

0.0008	11

Adults 20-49 years old

0.007	8.9

Adults 50+ years old

0.0006	8.7

Females 13-49 years old

0.0006	8.6

VII.	Characterization of Inputs/Outputs

	

	Anticipated residues for all registered and proposed food commodities
were based on field trial data and percent crop treated.  Although field
trial data provide more refined exposure estimates than tolerances, the
results may still be considered somewhat conservative, since field
trials are conducted under maximum use conditions (maximum allowed
application rate and number of applications, minimum PHI, etc.).  

VIII.	Conclusions

	

	Acute and chronic dietary exposure analyses (including food and water)
were performed in order to determine the exposure and risks resulting
from the registered uses and new proposed uses of fluazifop-p-butyl. 
Tolerance level values with a ratio adjustment for additional
metabolites of concern, default processing factors, and refined point
estimates for residues in water were used in these assessments. Percent
CT refinements were included for the acute and chronic dietary exposure
analysis.  This assessment concludes that for all supported registered
commodities and new proposed uses, the acute dietary risk estimates are
below the Agency’s level of concern (<100 %aPAD) for  females 13-49
years of age (<13 % aPAD) at the 95th exposure percentile.  Chronic
dietary risk estimates are provided for the U.S. population (total) and
various population subgroups.  The chronic assessment concludes that for
all supported commodities and proposed uses, the chronic dietary risk
estimates are below the Agency’s level of concern  (<100 %cPAD) for
the U.S. population (12% cPAD) and all population subgroups.  The most
highly exposed population subgroup in the chronic dietary exposure
analysis is children 1-2 years of age (40% cPAD).

VIII.	List of Attachments

Acute Food plus Water Residue Input file.

Chronic Food plus Water Residue Input file.

Acute Results file.

Chronic Results file.

Percent Crop Treated Memo from BEAD

Attachment: Acute Food plus Water Residue Input File

Filename: C:\Documents and Settings\stadayon\My Documents\Work in
Progress\122809a.R98

Chemical: Fluazifop p butyl

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

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

Date created/last modified: 07-27-2010/13:23:34/8          Program ver.
2.03

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

12000120 12   Apricot                            0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12000121 12   Apricot-babyfood                   0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12000130 12   Apricot, dried                     0.095000   6.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12000140 12   Apricot, juice                     0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12000141 12   Apricot, juice-babyfood            0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

95000190 O    Asparagus                          3.360000   1.000  0.010
 Ratio 

          Full comment: Ratio from celery metabolism

95000230 O    Banana                             0.019000   1.000  1.000
 

95000231 O    Banana-babyfood                    0.019000   1.000  1.000
 

95000240 O    Banana, dried                      0.019000   1.000  1.000
 

95000241 O    Banana, dried-babyfood             0.019000   1.000  1.000
 

06030300 6C   Bean, black, seed                 95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030320 6C   Bean, broad, seed                 95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030340 6C   Bean, cowpea, seed                95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030350 6C   Bean,  great northern, seed       95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030360 6C   Bean, kidney, seed                95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030380 6C   Bean, lima, seed                  95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030390 6C   Bean, mung, seed                  95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030400 6C   Bean, navy, seed                  95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030410 6C   Bean, pink, seed                  95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06030420 6C   Bean, pinto, seed                 95.000000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

21000440 M    Beef, meat                         0.050000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.050000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.050000   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000
 

21000470 M    Beef, fat                          0.050000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000
 

21000480 M    Beef, kidney                       0.050000   1.000  1.000
 

21000490 M    Beef, liver                        0.050000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000
 

01010500 1AB  Beet, garden, roots                0.475000   1.000  1.000
 

01010501 1AB  Beet, garden, roots-babyfood       0.475000   1.000  1.000
 

02000510 2    Beet, garden, tops                 2.850000   1.000  1.000
 

01010520 1A   Beet, sugar                        0.475000   1.000  1.000
 

01010521 1A   Beet, sugar-babyfood               0.475000   1.000  1.000
 

01010530 1A   Beet, sugar, molasses              6.650000   1.000  1.000
 

01010531 1A   Beet, sugar, molasses-babyfood     6.650000   1.000  1.000
 

01010780 1AB  Carrot                             2.500000   1.000  0.100
 Ratio 

          Full comment: Ratio from carrot metabolism

01010781 1AB  Carrot-babyfood                    2.500000   1.000  0.100
 Ratio 

          Full comment: Ratio from carrot metabolism

01010790 1AB  Carrot, juice                      2.500000   1.000  0.100
 Ratio 

          Full comment: Ratio from carrot metabolism

12000900 12   Cherry                             0.095000   1.000  1.000
 

12000901 12   Cherry-babyfood                    0.095000   1.000  1.000
 

12000910 12   Cherry, juice                      0.095000   1.500  1.000
 

12000911 12   Cherry, juice-babyfood             0.095000   1.500  1.000
 

40000930 P    Chicken, meat                      0.050000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.050000   1.000  1.000
 

40000940 P    Chicken, liver                     0.050000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.050000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.050000   1.000  1.000
 

40000960 P    Chicken, fat                       0.050000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.050000   1.000  1.000
 

40000970 P    Chicken, skin                      0.050000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.050000   1.000  1.000
 

06030980 6C   Chickpea, seed                    95.000000   1.000  1.000
 

06030981 6C   Chickpea, seed-babyfood           95.000000   1.000  1.000
 

06030990 6C   Chickpea, flour                   95.000000   1.000  1.000
 

10001060 10   Citrus citron                      0.100000   1.000  1.000
 

10001070 10   Citrus hybrids                     0.100000   1.000  1.000
 

10001080 10   Citrus, oil                        0.100000   1.000  1.000
 

95001150 O    Coffee, roasted bean               0.190000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

95001160 O    Coffee, instant                    0.190000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

95001280 O    Cottonseed, oil                    0.380000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

95001281 O    Cottonseed, oil-babyfood           0.380000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

70001450 P    Egg, whole                         0.050000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.050000   1.000  1.000
 

70001460 P    Egg, white                         0.050000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.050000   1.000  1.000
 

70001470 P    Egg, yolk                          0.050000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.050000   1.000  1.000
 

04011500 4A   Endive                             6.960000   1.000  1.000
 

03001640 3    Garlic                             0.625000   1.000  1.000
 

03001650 3    Garlic, dried                      0.625000   9.000  1.000
 

03001651 3    Garlic, dried-babyfood             0.625000   9.000  1.000
 

23001690 M    Goat, meat                         0.050000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000
 

23001710 M    Goat, fat                          0.050000   1.000  1.000
 

23001720 M    Goat, kidney                       0.050000   1.000  1.000
 

23001730 M    Goat, liver                        0.050000   1.000  1.000
 

13021740 13B  Gooseberry                         0.019000   1.000  1.000
 

95001750 O    Grape                              0.019000   1.000  1.000
 

95001760 O    Grape, juice                       0.019000   1.000  1.000
 

95001761 O    Grape, juice-babyfood              0.019000   1.000  1.000
 

95001770 O    Grape, leaves                      0.019000   1.000  1.000
 

95001780 O    Grape, raisin                      0.019000   1.000  1.000
 

95001790 O    Grape, wine and sherry             0.019000   1.000  1.000
 

10001800 10   Grapefruit                         0.100000   1.000  1.000
 

10001810 10   Grapefruit, juice                  0.100000   1.000  1.000
 

06031820 6C   Guar, seed                        95.000000   1.000  1.000
 

06031821 6C   Guar, seed-babyfood               95.000000   1.000  1.000
 

10001970 10   Kumquat                            0.100000   1.000  1.000
 

10001990 10   Lemon                              0.100000   1.000  1.000
 

10002000 10   Lemon, juice                       0.100000   1.000  1.000
 

10002001 10   Lemon, juice-babyfood              0.100000   1.000  1.000
 

10002010 10   Lemon, peel                        0.100000   1.000  1.000
 

06032030 6C   Lentil, seed                      95.000000   1.000  1.000
 

10002060 10   Lime                               0.100000   1.000  1.000
 

10002070 10   Lime, juice                        0.100000   1.000  1.000
 

10002071 10   Lime, juice-babyfood               0.100000   1.000  1.000
 

14002130 14   Macadamia nut                      0.190000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

27002220 D    Milk, fat                          0.050000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000
 

27022240 D    Milk, water                        0.050000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000
 

12002300 12   Nectarine                          0.095000   1.000  1.000
 

03002370 3    Onion, dry bulb                    0.625000   1.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

03002371 3    Onion, dry bulb-babyfood           0.625000   1.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

03002380 3    Onion, dry bulb, dried             0.625000   9.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

03002381 3    Onion, dry bulb, dried-babyfood    0.625000   9.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

10002400 10   Orange                             0.100000   1.000  1.000
 

10002410 10   Orange, juice                      0.100000   1.000  1.000
 

10002411 10   Orange, juice-babyfood             0.100000   1.000  1.000
 

10002420 10   Orange, peel                       0.100000   1.000  1.000
 

12002600 12   Peach                              0.095000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002601 12   Peach-babyfood                     0.095000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002610 12   Peach, dried                       0.095000   7.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002611 12   Peach, dried-babyfood              0.095000   7.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002620 12   Peach, juice                       0.095000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002621 12   Peach, juice-babyfood              0.095000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

95002630 O    Peanut                             2.850000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

95002640 O    Peanut, butter                     2.850000   1.890  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

95002650 O    Peanut, oil                        2.850000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

14002690 14   Pecan                              0.095000   1.000  1.000
 

08002720 8    Pepper, nonbell                    1.120000   1.000  1.000
 Ratio 

          Full comment: Ratio from celery metabolism

08002721 8    Pepper, nonbell-babyfood           1.120000   1.000  1.000
 Ratio 

          Full comment: Ratio from celery metabolism

08002730 8    Pepper, nonbell, dried             1.120000   1.000  1.000
 Ratio 

          Full comment: Ratio from celery metabolism

12002850 12   Plum                               0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002851 12   Plum-babyfood                      0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002860 12   Plum, prune, fresh                 0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002861 12   Plum, prune, fresh-babyfood        0.095000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002870 12   Plum, prune, dried                 0.095000   5.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002871 12   Plum, prune, dried-babyfood        0.095000   5.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002880 12   Plum, prune, juice                 0.095000   1.400  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002881 12   Plum, prune, juice-babyfood        0.095000   1.400  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

25002900 M    Pork, meat                         0.050000   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.050000   1.000  1.000
 

25002910 M    Pork, skin                         0.050000   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.050000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.050000   1.000  1.000
 

25002930 M    Pork, fat                          0.050000   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.050000   1.000  1.000
 

25002940 M    Pork, kidney                       0.050000   1.000  1.000
 

25002950 M    Pork, liver                        0.050000   1.000  1.000
 

01032960 1C   Potato, chips                      1.250000   3.300  1.000
 

01032970 1C   Potato, dry (granules/ flakes)     1.250000   6.400  1.000
 

01032971 1C   Potato, dry (granules/ flakes)-b   1.250000   6.400  1.000
 

01032980 1C   Potato, flour                      1.250000   6.400  1.000
 

01032981 1C   Potato, flour-babyfood             1.250000   6.400  1.000
 

01032990 1C   Potato, tuber, w/peel              1.250000   1.400  1.000
 

01032991 1C   Potato, tuber, w/peel-babyfood     1.250000   1.400  1.000
 

01033000 1C   Potato, tuber, w/o peel            1.250000   1.400  1.000
 

01033001 1C   Potato, tuber, w/o peel-babyfood   1.250000   1.400  1.000
 

60003010 P    Poultry, other, meat               0.050000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.050000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.050000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.050000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.050000   1.000  1.000
 

10003070 10   Pummelo                            0.050000   1.000  1.000
 

04023220 4B   Rhubarb                            0.560000   1.000  1.000
 Ratio 

          Full comment: Ratio from celery metabolism

26003390 M    Sheep, meat                        0.050000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.050000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000
 

26003410 M    Sheep, fat                         0.050000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.050000   1.000  1.000
 

26003430 M    Sheep, liver                       0.050000   1.000  1.000
 

06003470 6    Soybean, seed                      4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06003480 6    Soybean, flour                     4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06003481 6    Soybean, flour-babyfood            4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06003490 6    Soybean, soy milk                  4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06003491 6    Soybean, soy milk-babyfood or in   4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06003500 6    Soybean, oil                       4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

06003501 6    Soybean, oil-babyfood              4.750000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

04013550 4A   Spinach                            6.960000   1.000  1.000
 Ratio 

          Full comment: Ratio from celery metabolism

04013551 4A   Spinach-babyfood                   6.960000   1.000  1.000
 Ratio 

          Full comment: Ratio from celery metabolism

01033660 1CD  Sweet potato                       1.250000   1.000  1.000
 Ratio 

          Full comment: Ratio from carrot metabolism

01033661 1CD  Sweet potato-babyfood              1.250000   1.000  1.000
 Ratio 

          Full comment: Ratio from carrot metabolism

10003690 10   Tangerine                          0.050000   1.000  1.000
 

10003700 10   Tangerine, juice                   0.050000   1.000  1.000
 

50003820 P    Turkey, meat                       0.050000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.050000   1.000  1.000
 

50003830 P    Turkey, liver                      0.050000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.050000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.050000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.050000   1.000  1.000
 

50003850 P    Turkey, fat                        0.050000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.050000   1.000  1.000
 

50003860 P    Turkey, skin                       0.050000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.050000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.033400   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.033400   1.000  1.000
 

01034060 1CD  Yam, true                          1.250000   1.000  1.000
 

01034070 1CD  Yam bean                           1.250000   1.000  1.000
 

	

Attachment: Chronic Food plus Water Residue Input File

Filename: C:\Documents and Settings\stadayon\My Documents\Work in
Progress\122809c 2010 .R98

Chemical: Fluazifop p butyl

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

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

Date created/last modified: 07-28-2010/07:57:28/8          Program ver.
2.03

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

Note: No residue distributions have been assigned to
Commodities/FoodForms below

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

95000190 O    Asparagus                          0.640000   1.000  0.025
 Ratio 

          Full comment: Ratio from celery metabolism

95001150 O    Coffee, roasted bean               0.190000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

95001160 O    Coffee, instant                    0.190000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

95001280 O    Cottonseed, oil                    0.380000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

95001281 O    Cottonseed, oil-babyfood           0.380000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

95001750 O    Grape                              0.005000   1.000  1.900
 

95001760 O    Grape, juice                       0.005000   1.000  1.900
 

95001761 O    Grape, juice-babyfood              0.005000   1.000  1.900
 

95001770 O    Grape, leaves                      0.005000   1.000  1.900
 

95001780 O    Grape, raisin                      0.005000   1.000  1.900
 

95001790 O    Grape, wine and sherry             0.005000   1.000  1.900
 

95002630 O    Peanut                             0.760000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

95002640 O    Peanut, butter                     0.760000   1.890  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

95002650 O    Peanut, oil                        0.760000   0.010  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

86010000 O    Water, direct, all sources         0.006600   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.006600   1.000  1.000
 

21000440 M    Beef, meat                         0.050000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.050000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.050000   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000
 

21000470 M    Beef, fat                          0.050000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000
 

21000480 M    Beef, kidney                       0.050000   1.000  1.000
 

21000490 M    Beef, liver                        0.050000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000
 

23001690 M    Goat, meat                         0.050000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000
 

23001710 M    Goat, fat                          0.050000   1.000  1.000
 

23001720 M    Goat, kidney                       0.050000   1.000  1.000
 

23001730 M    Goat, liver                        0.050000   1.000  1.000
 

25002900 M    Pork, meat                         0.050000   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.050000   1.000  1.000
 

25002910 M    Pork, skin                         0.050000   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.050000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.050000   1.000  1.000
 

25002930 M    Pork, fat                          0.050000   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.050000   1.000  1.000
 

25002940 M    Pork, kidney                       0.050000   1.000  1.000
 

25002950 M    Pork, liver                        0.050000   1.000  1.000
 

26003390 M    Sheep, meat                        0.050000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.050000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000
 

26003410 M    Sheep, fat                         0.050000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.050000   1.000  1.000
 

26003430 M    Sheep, liver                       0.050000   1.000  1.000
 

40000930 P    Chicken, meat                      0.050000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.050000   1.000  1.000
 

40000940 P    Chicken, liver                     0.050000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.050000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.050000   1.000  1.000
 

40000960 P    Chicken, fat                       0.050000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.050000   1.000  1.000
 

40000970 P    Chicken, skin                      0.050000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.050000   1.000  1.000
 

70001450 P    Egg, whole                         0.050000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.050000   1.000  1.000
 

70001460 P    Egg, white                         0.050000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.050000   1.000  1.000
 

70001470 P    Egg, yolk                          0.050000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.050000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.050000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.050000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.050000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.050000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.050000   1.000  1.000
 

50003820 P    Turkey, meat                       0.050000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.050000   1.000  1.000
 

50003830 P    Turkey, liver                      0.050000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.050000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.050000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.050000   1.000  1.000
 

50003850 P    Turkey, fat                        0.050000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.050000   1.000  1.000
 

50003860 P    Turkey, skin                       0.050000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.050000   1.000  1.000
 

27002220 D    Milk, fat                          0.050000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000
 

27022240 D    Milk, water                        0.050000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000
 

01010500 1AB  Beet, garden, roots                0.080000   1.000  1.900
 

01010501 1AB  Beet, garden, roots-babyfood       0.080000   1.000  1.900
 

01010520 1A   Beet, sugar                        0.080000   1.000  1.900
 

01010521 1A   Beet, sugar-babyfood               0.080000   1.000  1.900
 

01010530 1A   Beet, sugar, molasses              0.080000   1.000  1.900
 

01010531 1A   Beet, sugar, molasses-babyfood     0.080000   1.000  1.900
 

01010780 1AB  Carrot                             0.038000   1.000  0.100
 Ratio 

          Full comment: Ratio from carrot metabolism

01010781 1AB  Carrot-babyfood                    0.038000   1.000  0.100
 Ratio 

          Full comment: Ratio from carrot metabolism

01010790 1AB  Carrot, juice                      0.038000   1.500  0.100
 Ratio 

          Full comment: Ratio from carrot metabolism

01032960 1C   Potato, chips                      0.110000   3.300  1.250
 

01032970 1C   Potato, dry (granules/ flakes)     0.110000   6.400  1.250
 

01032971 1C   Potato, dry (granules/ flakes)-b   0.110000   6.400  1.250
 

01032980 1C   Potato, flour                      0.110000   6.400  1.250
 

01032981 1C   Potato, flour-babyfood             0.110000   6.400  1.250
 

01032990 1C   Potato, tuber, w/peel              0.110000   1.400  1.250
 

01032991 1C   Potato, tuber, w/peel-babyfood     0.110000   1.400  1.250
 

01033000 1C   Potato, tuber, w/o peel

01033001 1C   Potato, tuber, w/o peel-babyfood   0.110000   1.400  1.250
 

01033660 1CD  Sweet potato                       0.110000   1.000  1.250
 Ratio 

          Full comment: Ratio from carrot metabolism

01033661 1CD  Sweet potato-babyfood              0.110000   1.000  1.250
 Ratio 

          Full comment: Ratio from carrot metabolism

01034060 1CD  Yam, true                          0.110000   1.000  1.250
 

01034070 1CD  Yam bean                           0.110000   1.000  1.250
 

02000510 2    Beet, garden, tops                 1.300000   1.000  1.900
 

03001640 3    Garlic                             0.038000   1.000  0.050
 

03001650 3    Garlic, dried                      0.038000   9.000  0.050
 

03001651 3    Garlic, dried-babyfood             0.038000   9.000  0.050
 

03002370 3    Onion, dry bulb                    0.038000   1.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

03002371 3    Onion, dry bulb-babyfood           0.038000   1.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

03002380 3    Onion, dry bulb, dried             0.038000   9.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

03002381 3    Onion, dry bulb, dried-babyfood    0.038000   9.000  0.150
 Ratio 

          Full comment: Ratio from carrot metabolism

04011500 4A   Endive                             0.050000   1.000  1.160
 

04023220 4B   Rhubarb                            0.190000   1.000  1.120
 Ratio 

          Full comment: Ratio from celery metabolism

04013550 4A   Spinach                            0.050000   1.000  1.160
 Ratio 

          Full comment: Ratio from celery metabolism

04013551 4A   Spinach-babyfood                   0.050000   1.000  1.160
 Ratio 

          Full comment: Ratio from celery metabolism

06030300 6C   Bean, black, seed                 10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030320 6C   Bean, broad, seed                 10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030340 6C   Bean, cowpea, seed                10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030350 6C   Bean,  great northern, seed       10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030360 6C   Bean, kidney, seed                10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030380 6C   Bean, lima, seed                  10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030390 6C   Bean, mung, seed                  10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030400 6C   Bean, navy, seed                  10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030410 6C   Bean, pink, seed                  10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030420 6C   Bean, pinto, seed                 10.260000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

06030980 6C   Chickpea, seed                    10.260000   1.000  0.010
 

06030981 6C   Chickpea, seed-babyfood           10.260000   1.000  0.010
 

06030990 6C   Chickpea, flour                   10.260000   1.000  0.010
 

06031820 6C   Guar, seed                        10.260000   1.000  0.010
 

06031821 6C   Guar, seed-babyfood               10.260000   1.000  0.010
 

06032030 6C   Lentil, seed                      10.260000   1.000  0.010
 

06003470 6    Soybean, seed                      1.900000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

06003480 6    Soybean, flour                     1.900000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

06003481 6    Soybean, flour-babyfood            1.900000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

06003490 6    Soybean, soy milk                  1.900000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

06003491 6    Soybean, soy milk-babyfood or in   1.900000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

06003500 6    Soybean, oil                       1.900000   0.010  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

06003501 6    Soybean, oil-babyfood              1.900000   0.010  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

08002720 8    Pepper, nonbell                    0.670000   1.000  0.010
 Ratio 

          Full comment: Ratio from celery metabolism

08002721 8    Pepper, nonbell-babyfood           0.670000   1.000  0.010
 Ratio 

          Full comment: Ratio from celery metabolism

08002730 8    Pepper, nonbell, dried             0.670000   1.000  0.010
 Ratio 

          Full comment: Ratio from celery metabolism

10001060 10   Citrus citron                      0.005000   1.000  1.900
 

10001070 10   Citrus hybrids                     0.005000   1.000  1.900
 

10001080 10   Citrus, oil                        0.005000   1.000  1.900
 

10001800 10   Grapefruit                         0.005000   1.000  1.900
 

10001810 10   Grapefruit, juice                  0.005000   1.000  1.900
 

10001970 10   Kumquat                            0.005000   1.000  1.900
 

10001990 10   Lemon                              0.005000   1.000  1.900
 

10002000 10   Lemon, juice                       0.005000   1.000  1.900
 

10002001 10   Lemon, juice-babyfood              0.005000   1.000  1.900
 

10002010 10   Lemon, peel                        0.005000   1.000  1.900
 

10002060 10   Lime                               0.005000   1.000  1.900
 

10002070 10   Lime, juice                        0.005000   1.000  1.900
 

10002071 10   Lime, juice-babyfood               0.005000   1.000  1.900
 

10002400 10   Orange                             0.005000   1.000  1.900
 

10002410 10   Orange, juice                      0.005000   1.000  1.900
 

10002411 10   Orange, juice-babyfood             0.005000   1.000  1.900
 

10002420 10   Orange, peel                       0.005000   1.000  1.900
 

10003070 10   Pummelo                            0.005000   1.000  1.900
 

10003690 10   Tangerine                          0.005000   1.000  1.900
 

10003700 10   Tangerine, juice                   0.005000   1.000  1.900
 

12000120 12   Apricot                            0.015000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

12000121 12   Apricot-babyfood                   0.015000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

12000130 12   Apricot, dried                     0.015000   6.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

12000140 12   Apricot, juice                     0.015000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

12000141 12   Apricot, juice-babyfood            0.015000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

12000900 12   Cherry                             0.029000   1.000  0.010
 

12000901 12   Cherry-babyfood                    0.029000   1.000  0.010
 

12000910 12   Cherry, juice                      0.029000   1.500  0.010
 

12000911 12   Cherry, juice-babyfood             0.029000   1.500  0.010
 

12002300 12   Nectarine                          0.015000   1.000  1.900
 

12002600 12   Peach                              0.029000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

12002601 12   Peach-babyfood                     0.029000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

12002610 12   Peach, dried                       0.029000   7.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

12002611 12   Peach, dried-babyfood              0.029000   7.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

12002620 12   Peach, juice                       0.029000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

12002621 12   Peach, juice-babyfood              0.029000   1.000  0.025
 Ratio 

          Full comment: Ratio from soybean metabolism

12002850 12   Plum                               0.019000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002851 12   Plum-babyfood                      0.019000   1.000  1.000
 Ratio 

          Full comment: Ratio from soybean metabolism

12002860 12   Plum, prune, fresh                 0.019000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002861 12   Plum, prune, fresh-babyfood        0.019000   1.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002870 12   Plum, prune, dried                 0.019000   5.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002871 12   Plum, prune, dried-babyfood        0.019000   5.000  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002880 12   Plum, prune, juice                 0.019000   1.400  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

12002881 12   Plum, prune, juice-babyfood        0.019000   1.400  0.010
 Ratio 

          Full comment: Ratio from soybean metabolism

14002130 14   Macadamia nut                      0.050000   1.000  1.900
 Ratio 

          Full comment: Ratio from soybean metabolism

14002690 14   Pecan                              0.050000   1.000  1.900
 

Attachment:  Acute Food plus Water Results File

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUAZIFOP P BUTYL                  
(1994-98 data)

Residue file: 122809a.R98                         Adjustment factor #2
NOT used.

Analysis Date: 07-27-2010/14:01:47    Residue file dated:
07-27-2010/13:23:34/8

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure  
% aRfD 

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

Females 13-49 yrs:

                    0.064111    12.82    0.151503    30.30    0.367295  
 73.46 

Attachment:  Chronic Food plus Water Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FLUAZIFOP P BUTYL                (1994-98
data)

Residue file name: C:\Documents and Settings\stadayon\My Documents\Work
in Progress\122809c 2010 .R98

Adjustment factor #2 used.

Analysis Date 07-28-2010/07:59:35     Residue file dated:
07-28-2010/07:57:28/8

Reference dose (RfD, Chronic) = .0074 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000904               
12.2%

U.S. Population (spring season)             0.000903               
12.2%

U.S. Population (summer season)             0.000885               
12.0%

U.S. Population (autumn season)             0.000925               
12.5%

U.S. Population (winter season)             0.000902               
12.2%

Northeast region                            0.000874               
11.8%

Midwest region                              0.000963               
13.0%

Southern region                             0.000853               
11.5%

Western region                              0.000949               
12.8%

Hispanics                                   0.001045               
14.1%

Non-hispanic whites                         0.000887               
12.0%

Non-hispanic blacks                         0.000856               
11.6%

Non-hisp/non-white/non-black                0.000980               
13.2%

All infants (< 1 year)                      0.001482               
20.0%

Nursing infants                             0.000521                
7.0%

Non-nursing infants                         0.001846               
25.0%

Children 1-6 yrs                           0.002423                
32.7%

Children 7-12 yrs                           0.001322               
17.9%

Females 13-19 (not preg or nursing)         0.000685                
9.3%

Females 20+ (not preg or nursing)           0.000624                
8.4%

Females 13-50 yrs                           0.000708                
9.6%

Females 13+ (preg/not nursing)              0.000785               
10.6%

Females 13+ (nursing)                       0.000879               
11.9%

Males 13-19 yrs                             0.000883               
11.9%

Males 20+ yrs                               0.000680                
9.2%

Seniors 55+                                 0.000644                
8.7%

Children 1-2 yrs                            0.002988               
40.4%

Children 3-5 yrs                            0.002231               
30.1%

Children 6-12 yrs                           0.001406               
19.0%

Youth 13-19 yrs                             0.000787               
10.6%

Adults 20-49 yrs                            0.000659                
8.9%

Adults 50+ yrs                              0.000643                
8.7%

Females 13-49 yrs                           0.000639                
8.6%

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

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

Attachment Percent Crop Treated Memo from BEAD

Fluazifop-p-butyl	Dietary Exposure Assessment	DP Bar code: D379452

PC Code: 122809		

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