Document ID: EPA-HQ-OPP-2006-1026-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-08-15T04:00Z

SEQ CHAPTER \h \r 1 

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	8-JUNE-2007

SUBJECT:	Pyrasulfotole.  Acute and Chronic Dietary Exposure and Risk
Assessments for Section 3 Registration on Small Cereal Grains.  DP#
333435.  Decision # 366490.  Chemical: 000692.

		

FROM/TO:	Jennifer R. Tyler, Chemist

		Registration Action Branch (RAB1)

		Health Effects Division (HED) (7509C)

THROUGH:	PV Shah, Ph.D., Branch Senior Scientist

RAB1/HED (7509C)

				and

		David Hrdy, Sr. Biologist

		Christina Swartz, Chemist

		Dietary Exposure Science Advisory Council (DESAC)/HED (7509C)

Executive Summary

Acute and chronic dietary (food and drinking water) exposure analyses
were requested in order to determine the dietary exposure estimates
associated with the HED-recommended tolerances for residues of the
herbicide pyrasulfotole in/on small cereal grains and livestock
commodities.  No cancer dietary exposure assessment was performed
because pyrasulfotole is not carcinogenic.

An unrefined, acute dietary exposure assessment was performed for the
general U.S. population and all other population subgroups (including
infants and children) using tolerance-level residues and assuming 100%
crop treated (CT) for all proposed uses.  Drinking water was
incorporated directly into the dietary assessment using the acute
concentration for surface water generated by the FQPA Index Reservoir
Screening Tool (FIRST) model.  The results of this assessment indicate
that the acute dietary exposure estimates (95th percentile) are below
HED’s level of concern [<100% of the acute Population Adjusted Dose
(aPAD)] for the general U.S. population (2% of the aPAD) and all other
populations subgroups.  The most highly exposed population subgroup is
children 1-2 years old at 4% of the cPAD.

An unrefined, chronic dietary exposure assessment was performed for the
general U.S. population and various population subgroups using
tolerance-level residues and assuming 100% CT for all proposed uses. 
Drinking water was incorporated directly into the dietary assessment
using the chronic concentration for surface water generated by the FIRST
model.  The results of the assessment concludes that the chronic dietary
exposure estimates are below HED’s level of concern [<100% of the
chronic Population Adjusted Dose (cPAD)] for the general U.S. population
(2% of the cPAD) and all population subgroups.  The most highly exposed
population subgroup is children 1-2 years old at 7% of the cPAD.

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.  This is the
PAD, which HED has concluded will result in no unreasonable adverse
health effects.  The PAD is the reference dose (RfD) divided by the FQPA
10x Safety Factor.  Dietary risk is expressed as a percentage of the
PAD.  HED is concerned when estimated dietary risk exceeds 100% of the
PAD.  References which discuss the acute and chronic risk assessment in
more detail are available on the EPA/pesticides web site:  “Available
Information on Assessing Exposure from Pesticides, A User’s Guide”,
6/21/2000, web link:   HYPERLINK "http://www.epa.gov/fedrgstr/" 
http://www.epa.gov/fedrgstr/  EPA_PEST/2000/July/Day_12/6061.pdf; or see
SOP 99.6 (8/20/99).  The current 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).  This is the first dietary exposure assessment for pyrasulfotole.

Residue Information

Proposed Tolerances:  The available residue chemistry database supports
the establishment of permanent tolerances for the combined residues of
pyrasulfotole and pyrasulfotole-desmethyl in/on the following raw
agricultural and livestock commodities:

Wheat, grain	0.02 ppm	Cattle, liver	0.35 ppm

Wheat, straw	0.20 ppm	Goat, meat	0.02 ppm

Wheat, forage	0.20 ppm	Goat, fat	0.02 ppm

Wheat, hay	0.80 ppm	Goat, meat byproducts, except liver	0.06 ppm

Aspirated grain fractions	0.40 ppm	Goat, liver	0.35 ppm

Oat, grain	0.08 ppm	Sheep, meat	0.02 ppm

Oat, straw	0.20 ppm	Sheep, fat	0.02 ppm

Oat, forage	0.10 ppm	Sheep, meat byproducts, except liver	0.06 ppm

Oat, hay	0.50 ppm	Sheep, liver	0.35 ppm

Barley, grain	0.02 ppm	Horse, meat byproducts, except liver	0.05 ppm

Barley, straw	0.20 ppm	Horse, liver	0.30 ppm

Barley, hay	0.30 ppm	Hog, meat	0.02 ppm

Rye, grain	0.02 ppm	Hog, fat	0.02 ppm

Rye, straw	0.20 ppm	Hog, meat byproducts	0.02 ppm

Rye, forage	0.20 ppm	Poultry, meat	0.02 ppm

Milk	0.01 ppm	Poultry, fat	0.02 ppm

Cattle, meat	0.02 ppm	Poultry, meat byproducts	0.02 ppm

Cattle, fat	0.02 ppm	Eggs	0.02 ppm

Cattle, meat byproducts, except liver	0.06 ppm

Nature of the Residue:

Plants:  Based on the results of the wheat metabolism studies,
pyrasulfotole and pyrasulfotole-desmethyl are the residues of concern
for tolerances and risk assessment purposes (Memo, J. Tyler et al.,
06/08/07; D328640).  This conclusion applies only to the use of
pyrasulfotole on small cereal grains.  Any future uses on other crops,
such as leafy vegetables, or legumes, may require the submission of
additional metabolism data.

Livestock:  Based on the results of the dairy cattle and laying hen
metabolism studies, the residues of concern in livestock for tolerance
and risk assessment purposes are parent and the desmethyl metabolite
(Memo, J. Tyler et al., 06/08/07; D328640).

Drinking Water:  The residues of concern in drinking water for risk
assessment purposes are parent only (Memo, J. Tyler et al., 06/08/07;
D328640).

Drinking Water Considerations:  The Environmental Fate and Effects
Division (EFED) provided Estimated Drinking Water Concentrations (EDWCs)
of pyrasulfotole in surface and ground water using the FIRST and
Screening Concentration in Ground Water (SCI-GROW) models, respectively.
 The assessment was based on the proposed small cereal grain use, which
has a maximum proposed seasonal application rate of 0.045 lb ai/A.  EFED
calculated the 1- in 10-year peak acute and 1- in 10-year estimated
annual mean non-cancer chronic EDWCs for pyrasulfotole in surface water
to be 4.0 ppb and 2.8 ppb, respectively.  The ground water EDWC for both
acute and chronic exposures in estimated as 1.4 ppb.

Percent Crop Treated:  For the acute and chronic assessments, it was
assumed that 100% of the proposed crops have been treated with
pyrasulfotole.

Residue and PDP Data:  HED-recommended tolerance level residues were
used for all proposed commodities in the acute and chronic assessments.

Processing Factors:  The results of the wheat processing study indicate
that residues of pyrasulfotole and pyrasulfotole-desmethyl do not appear
to concentrate in wheat flour (0.26x), middling (0.38x), shorts (0.56x)
and germ (0.70x).  Total residues of pyrasulfotole and
pyrasulfotole-desmethyl do appear to concentrate in aspirated wheat
grain fractions (33x), and wheat bran (1.6x).  Based on these processing
factors and a highest-average field trial (HAFT) residue of 0.011 ppm
from the wheat field trials, a separate tolerance is not needed for
wheat, bran, but a tolerance should be established for aspirated grain
fractions at 0.40 ppm.  In addition, based on the results of the
processed food/feed data on wheat, HED concludes that residues of
pyrasulfotole and pyrasulfotole-desmethyl are not expected to
concentrate in pearled barley, barley flour, oat flour, groats/rolled
oats, and rye flour.  Therefore, tolerances on these processed
commodities are not needed.  Because the results of the processing study
indicate that residues concentrated in wheat bran, residues can be
expected to concentrate in barley bran, oat bran and rye bran as well. 
Based on the 1.6x processing factor for wheat bran, and a HAFT residue
of 0.010 ppm from the barley field trials, the maximum expected residues
in barley bran would be 0.016 ppm, which is below the recommended 0.02
ppm tolerance for barley, grain.  Therefore, a separate tolerance is not
needed for barley, bran.  Based on the 1.6x processing factor for wheat
bran, and a HAFT residue of 0.109 ppm from the oat field trials, the
maximum expected residues in oat bran would be 0.17 ppm, which is above
the recommended 0.08 ppm tolerance for oat, grain.  Therefore, a
separate tolerance should be established for oat, bran at 0.20 ppm. 
However, according to current HED guidelines, HED does not currently set
tolerances on oat, bran.  The residue level will be incorporated into
the dietary exposure assessment.  Based on the 1.6x processing factor
for wheat bran, and a HAFT residue of 0.011 ppm from the wheat field
trials, the maximum expected residues in rye bran would be 0.018 ppm,
which is below the recommended 0.02 ppm tolerance for rye, grain. 
Therefore, a separate tolerance is not needed for wheat, bran.

DEEM-FCID™ Program and Consumption Information

The pyrasulfotole acute and chronic dietary exposure assessments were
conducted using DEEM-FCID™ (Version 2.03), which incorporates
consumption data from USDA’s 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.  Consumption
data are averaged for the entire U.S. population and within population
subgroups for chronic exposure assessment, but are retained as
individual consumption events for acute exposure assessment.

For chronic exposure and risk 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.  The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption 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 (Tier 1 or Tier 2) exposure assessment, or “matched”
in multiple random pairings with residue values and then summed in a
probabilistic (Tier 3/4) assessment.  The resulting distribution of
exposures is expressed as a percentage of the aPAD on both a user (i.e.,
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, significant differences in user vs. per
capita exposure and risk are identified and noted in the risk
assessment.

Toxicological Information

A summary of the toxicological doses and endpoints selected for dietary
exposure assessment is provided in Table 1.

Table 1.  Summary of Toxicological Doses and Endpoints for Pyrasulfotole
for Use in Dietary Human Health Risk Assessments.

Exposure Scenario	Point of Departure	Uncertainty/FQPA Safety Factors
RfD, PAD, Level of Concern for Risk Assessment	Study and Relevant
Toxicological Effects

Acute Dietary (All populations)	NOAEL = 3.8

mg/kg/day	UFA = 10X

UFH = 10X

UFFQPA = 1X 	aRfD = aPAD = 0.038 mg/kg/day	Developmental neurotoxicity
(rat; dietary) Offspring LOAEL = 37 mg/kg/day based on delayed preputial
separation (males), decreased cerebrum length (PND 21 females), and
decreased cerebellum height (PND 21 males)

Chronic Dietary (All populations)	NOAEL = 1.0

mg/kg/day	UFA = 10X

UFH = 10X

UFFQPA = 1X	cRfD = cPAD = 0.01mg/kg/day	Combined chronic
toxicity/carcinogenicity (rat; dietary) LOAEL = 10/14 mg/kg/day (M/F)
based on corneal opacity, neovascularization of the cornea, inflammation
of the cornea, regenerative corneal hyperplasia, corneal atrophy, and/or
retinal atrophy (both sexes), and hepatocellular hypertrophy along with
increased serum cholesterol (males)

Cancer (oral, dermal, inhalation)	Classification:  “Suggestive
Evidence of Carcinogenic Potential” based on increased incidences of
corneal tumors in male rats (carcinogenicity study) and urinary bladder
tumors in male and female mice (carcinogenicity study)

1  UF = uncertainty factor, UFA = extrapolation from animal to human
(interspecies), UFH = potential variation in sensitivity among members
of the human population (intraspecies), UFFQPA = FQPA Safety Factor,
NOAEL = no observed adverse effect level, LOAEL = lowest observed
adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD
= population adjusted dose.

Results/Discussion/Conclusions

-FCID™ analysis estimates the dietary exposure of the U.S. population
and 26 population subgroups.  The results reported in Table 2 are for
the U.S. Population, all infants (<1 year old), children 1-2, children
3-5, children 6-12, youth 13-19, females 13-49, males 20-49, and adults
50+ years.

An acute dietary exposure assessment (using tolerance level residues and
100% CT information for all proposed uses) was conducted for the general
U.S. population and various population subgroups (including infants and
children).  Drinking water was incorporated directly in the dietary
assessments using the acute concentration for surface water generated by
the FIRST model.  The results of the acute assessment indicate that the
acute dietary exposure estimates (95th percentile) are below HED’s
level of concern (<100% of the aPAD) for the general U.S. population (2%
of the aPAD) and all populations subgroups.  The most highly exposed
population subgroup is children 1-2 years old at 4% of the cPAD.

The chronic dietary exposure assessment (using tolerance level residues
and 100% CT information for all proposed uses) was conducted for the
general U.S. population and various population subgroups.  Drinking
water was incorporated directly into the dietary assessment using the
chronic concentration for surface water generated by the FIRST model. 
The results of the chronic assessment indicate that the chronic dietary
exposure estimates are below HED’s level of concern (<100% of the
cPAD) for the general U.S. population (2% of the cPAD) and all
population subgroups.  The most highly exposed population subgroup is
children 1-2 years old at 7% of the cPAD.

Table 2.  Summary of Dietary Exposure and Risk for Pyrasulfotole.

Population

Subgroup	Acute Dietary1	Chronic Dietary2

	Dietary Exposure

(mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD

U.S. Population (total)	0.000633	2	0.000224	2

All Infants (< 1 year old)	0.001259	3	0.000410	4

Children 1-2 years old	0.001393	4	0.000698	7

Children 3-5 years old	0.001053	3	0.000541	5

Children 6-12 years old	0.000691	2	0.000339	3

Youth 13-19 years old	0.000431	1	0.000190	2

Adults 20-49 years old	0.000378	1	0.000168	2

Adults 50+ years old	0.000331	1	0.000160	2

Females 13-49 years old	0.000368	1	0.000161	2

1 Acute dietary endpoint of 0.038 mg/kg/day applies to the general U.S.
population and all population subgroups.

2 Chronic dietary endpoint of 0.01 mg/kg/day applies to the general U.S.
population and all population subgroups.

List of Attachments

ute DEEM-FCID™ Analysis – All Populations.

Attachment 2.  Acute DEEM-FCID™ Analysis – All Populations.

Attachment 3:  Residue File for Chronic DEEM-FCID™ Analysis.

Attachment 4:  Chronic DEEM-FCID™ Analysis.

cc (w/ Attachments): J. Tyler, T. White (RD, 7505P); D. Kenny (RD;
7505P)

RDI: DE SAC [C. Swartz (5/30/07), D. Hrdy (5/23/07)]; G. Kramer
(06/08/07)

J.Tyler:S-10943:(703)305-5564: 7509C:RAB1

Attachment 1.  Residue File for Acute DEEM-FCID™ Analysis – All
Populations.

Filename: C:\Documents and Settings\jtyler\My
Documents\JenWork\$Pyrasulfatole\DEEM\000692a.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day  NOEL(Acute):  3.8 mg/kg bw/day

Date created/last modified: 06-06-2007/13:33:06/8          Program ver.
2.03

Comment: Proposed use on small cereal grains.  FQPA Safety Factor=1x;
therefore, aRfD=aPAD and cRfD=cPAD.

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

15000250 15   Barley, pearled barley             0.020000   1.000  1.000
 

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000
 

15000260 15   Barley, flour                      0.020000   1.000  1.000
 

15000261 15   Barley, flour-babyfood             0.020000   1.000  1.000
 

15000270 15   Barley, bran                       0.020000   1.000  1.000
 

21000440 M    Beef, meat                         0.020000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.020000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.020000   1.000  1.000
 

21000460 M    Beef, meat byproducts              0.060000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.060000   1.000  1.000
 

21000470 M    Beef, fat                          0.020000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.020000   1.000  1.000
 

21000480 M    Beef, kidney                       0.060000   1.000  1.000
 

21000490 M    Beef, liver                        0.350000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.350000   1.000  1.000
 

40000930 P    Chicken, meat                      0.020000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.020000   1.000  1.000
 

40000940 P    Chicken, liver                     0.020000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.020000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.020000   1.000  1.000
 

40000960 P    Chicken, fat                       0.020000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.020000   1.000  1.000
 

40000970 P    Chicken, skin                      0.020000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.020000   1.000  1.000
 

70001450 P    Egg, whole                         0.020000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000
 

70001460 P    Egg, white                         0.020000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000
 

70001470 P    Egg, yolk                          0.020000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000
 

23001690 M    Goat, meat                         0.020000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.060000   1.000  1.000
 

23001710 M    Goat, fat                          0.020000   1.000  1.000
 

23001720 M    Goat, kidney                       0.060000   1.000  1.000
 

23001730 M    Goat, liver                        0.350000   1.000  1.000
 

24001890 M    Horse, meat                        0.020000   1.000  1.000
 

28002210 M    Meat, game                         0.020000   1.000  1.000
 

27002220 D    Milk, fat                          0.010000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.010000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.010000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000
 

27022240 D    Milk, water                        0.010000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000
 

15002310 15   Oat, bran                          0.200000   1.000  1.000
 

15002320 15   Oat, flour                         0.080000   1.000  1.000
 

15002321 15   Oat, flour-babyfood                0.080000   1.000  1.000
 

15002330 15   Oat, groats/rolled oats            0.080000   1.000  1.000
 

15002331 15   Oat, groats/rolled oats-babyfood   0.080000   1.000  1.000
 

25002900 M    Pork, meat                         0.020000   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.020000   1.000  1.000
 

25002910 M    Pork, skin                         0.020000   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.020000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000
 

25002930 M    Pork, fat                          0.020000   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.020000   1.000  1.000
 

25002940 M    Pork, kidney                       0.020000   1.000  1.000
 

25002950 M    Pork, liver                        0.020000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.020000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.020000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.020000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.020000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.020000   1.000  1.000
 

29003120 M    Rabbit, meat                       0.020000   1.000  1.000
 

15003280 15   Rye, grain                         0.020000   1.000  1.000
 

15003290 15   Rye, flour                         0.020000   1.000  1.000
 

26003390 M    Sheep, meat                        0.020000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.020000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.060000   1.000  1.000
 

26003410 M    Sheep, fat                         0.020000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.020000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.060000   1.000  1.000
 

26003430 M    Sheep, liver                       0.350000   1.000  1.000
 

15003810 15   Triticale, flour                   0.020000   1.000  1.000
 

15003811 15   Triticale, flour-babyfood          0.020000   1.000  1.000
 

50003820 P    Turkey, meat                       0.020000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.020000   1.000  1.000
 

50003830 P    Turkey, liver                      0.020000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.020000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.020000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.020000   1.000  1.000
 

50003850 P    Turkey, fat                        0.020000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.020000   1.000  1.000
 

50003860 P    Turkey, skin                       0.020000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.020000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.004000   1.000  1.000
 4.0 pp

          Full comment: 4.0 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.004000   1.000  1.000
 4.0 pp

          Full comment: 4.0 ppb surface water EDWC

15004010 15   Wheat, grain                       0.020000   1.000  1.000
 

15004011 15   Wheat, grain-babyfood              0.020000   1.000  1.000
 

15004020 15   Wheat, flour                       0.020000   1.000  1.000
 

15004021 15   Wheat, flour-babyfood              0.020000   1.000  1.000
 

15004030 15   Wheat, germ                        0.020000   1.000  1.000
 

15004040 15   Wheat, bran                        0.020000   1.000  1.000
 

Attachment 2.  Acute DEEM-FCID™ Analysis – General U.S. Population,
Including Infants and Children.

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 000692a.R98                         Adjustment factor #2
NOT used.

Analysis Date: 06-06-2007/13:34:48    Residue file dated:
06-06-2007/13:33:06/8

NOEL (Acute) =   3.800000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Proposed use on small cereal grains.  FQPA Safety
Factor=1x; the

refore, aRfD=aPAD and cRfD=cPAD."

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

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

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

U.S. Population:

  0.000633    1.67    6005    0.001039    2.74    3655    0.001747   
4.60    2175  

All infants:

  0.001259    3.31    3018    0.001913    5.04    1985    0.002750   
7.24    1382  

Children 1-2 yrs:

  0.001393    3.67    2727    0.001847    4.86    2057    0.002698   
7.10    1408  

Children 3-5 yrs:

  0.001053    2.77    3610    0.001434    3.77    2649    0.002675   
7.04    1420  

Children 6-12 yrs:

  0.000691    1.82    5502    0.000922    2.43    4119    0.001358   
3.57    2797  

Youth 13-19 yrs:

  0.000431    1.13    8818    0.000635    1.67    5981    0.001056   
2.78    3600  

Adults 20-49 yrs:

  0.000378    0.99   10060    0.000535    1.41    7096    0.000885   
2.33    4292  

Adults 50+ yrs:

  0.000331    0.87   11476    0.000439    1.15    8664    0.000966   
2.54    3933  

Females 13-49 yrs:

  0.000368    0.97   10330    0.000518    1.36    7340    0.000888   
2.34    4277  

FCID™ Analysis.

Filename: C:\Documents and Settings\jtyler\My
Documents\JenWork\$Pyrasulfatole\DEEM\000692c.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day  NOEL(Acute):  3.8 mg/kg bw/day

Date created/last modified: 06-06-2007/13:33:53/8          Program ver.
2.03

Comment:  Proposed use on small cereal grains.  FQPA safety factor=1x;
therefore, aRfD=aPAD and cRfD=cPAD.

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

15000250 15   Barley, pearled barley             0.020000   1.000  1.000
 

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000
 

15000260 15   Barley, flour                      0.020000   1.000  1.000
 

15000261 15   Barley, flour-babyfood             0.020000   1.000  1.000
 

15000270 15   Barley, bran                       0.020000   1.000  1.000
 

21000440 M    Beef, meat                         0.020000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.020000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.020000   1.000  1.000
 

21000460 M    Beef, meat byproducts              0.060000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.060000   1.000  1.000
 

21000470 M    Beef, fat                          0.020000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.020000   1.000  1.000
 

21000480 M    Beef, kidney                       0.060000   1.000  1.000
 

21000490 M    Beef, liver                        0.350000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.350000   1.000  1.000
 

40000930 P    Chicken, meat                      0.020000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.020000   1.000  1.000
 

40000940 P    Chicken, liver                     0.020000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.020000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.020000   1.000  1.000
 

40000960 P    Chicken, fat                       0.020000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.020000   1.000  1.000
 

40000970 P    Chicken, skin                      0.020000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.020000   1.000  1.000
 

70001450 P    Egg, whole                         0.020000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000
 

70001460 P    Egg, white                         0.020000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000
 

70001470 P    Egg, yolk                          0.020000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000
 

23001690 M    Goat, meat                         0.020000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.060000   1.000  1.000
 

23001710 M    Goat, fat                          0.020000   1.000  1.000
 

23001720 M    Goat, kidney                       0.060000   1.000  1.000
 

23001730 M    Goat, liver                        0.350000   1.000  1.000
 

24001890 M    Horse, meat                        0.020000   1.000  1.000
 

28002210 M    Meat, game                         0.020000   1.000  1.000
 

27002220 D    Milk, fat                          0.010000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.010000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.010000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000
 

27022240 D    Milk, water                        0.010000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000
 

15002310 15   Oat, bran                          0.200000   1.000  1.000
 

15002320 15   Oat, flour                         0.080000   1.000  1.000
 

15002321 15   Oat, flour-babyfood                0.080000   1.000  1.000
 

15002330 15   Oat, groats/rolled oats            0.080000   1.000  1.000
 

15002331 15   Oat, groats/rolled oats-babyfood   0.080000   1.000  1.000
 

25002900 M    Pork, meat                         0.020000   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.020000   1.000  1.000
 

25002910 M    Pork, skin                         0.020000   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.020000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000
 

25002930 M    Pork, fat                          0.020000   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.020000   1.000  1.000
 

25002940 M    Pork, kidney                       0.020000   1.000  1.000
 

25002950 M    Pork, liver                        0.020000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.020000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.020000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.020000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.020000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.020000   1.000  1.000
 

29003120 M    Rabbit, meat                       0.020000   1.000  1.000
 

15003280 15   Rye, grain                         0.020000   1.000  1.000
 

15003290 15   Rye, flour                         0.020000   1.000  1.000
 

26003390 M    Sheep, meat                        0.020000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.020000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.060000   1.000  1.000
 

26003410 M    Sheep, fat                         0.020000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.020000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.060000   1.000  1.000
 

26003430 M    Sheep, liver                       0.350000   1.000  1.000
 

15003810 15   Triticale, flour                   0.020000   1.000  1.000
 

15003811 15   Triticale, flour-babyfood          0.020000   1.000  1.000
 

50003820 P    Turkey, meat                       0.020000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.020000   1.000  1.000
 

50003830 P    Turkey, liver                      0.020000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.020000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.020000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.020000   1.000  1.000
 

50003850 P    Turkey, fat                        0.020000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.020000   1.000  1.000
 

50003860 P    Turkey, skin                       0.020000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.020000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.002800   1.000  1.000
 2.8 pp

          Full comment: 2.8 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.002800   1.000  1.000
 2.8 pp

          Full comment: 2.8 ppb surface water EDWC

15004010 15   Wheat, grain                       0.020000   1.000  1.000
 

15004011 15   Wheat, grain-babyfood              0.020000   1.000  1.000
 

15004020 15   Wheat, flour                       0.020000   1.000  1.000
 

15004021 15   Wheat, flour-babyfood              0.020000   1.000  1.000
 

15004030 15   Wheat, germ                        0.020000   1.000  1.000
 

15004040 15   Wheat, bran                        0.020000   1.000  1.000
 

:  Chronic DEEM-FCID™ Analysis.

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\jtyler\My
Documents\JenWork\$Pyrasulfatole\DEEM\000692c.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 06-06-2007/13:35:21     Residue file dated:
06-06-2007/13:33:53/8

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

COMMENT 1: Proposed use on small cereal grains.  FQPA safety factor=1x;
therefore, aRfD=aPAD and cRfD=cPAD.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

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U.S. Population (spring season)             0.000222                
2.2%

U.S. Population (summer season)             0.000224                
2.2%

U.S. Population (autumn season)             0.000227                
2.3%

U.S. Population (winter season)             0.000221                
2.2%

Northeast region                            0.000221                
2.2%

Midwest region                              0.000233                
2.3%

Southern region                             0.000209                
2.1%

Western region                              0.000239                
2.4%

Hispanics                                   0.000255                
2.6%

Non-hispanic whites                         0.000218                
2.2%

Non-hispanic blacks                         0.000222                
2.2%

Non-hisp/non-white/non-black                0.000246                
2.5%

All infants (< 1 year)                      0.000410                
4.1%

Nursing infants                             0.000155                
1.6%

Non-nursing infants                         0.000506                
5.1%

Children 1-6  yrs                           0.000580                
5.8%

Children 7-12 yrs                           0.000318                
3.2%

Females 13-19 (not preg or nursing)         0.000166                
1.7%

Females 20+ (not preg or nursing)           0.000158                
1.6%

Females 13-50 yrs                           0.000177                
1.8%

Females 13+ (preg/not nursing)              0.000192                
1.9%

Females 13+ (nursing)                       0.000227                
2.3%

Males 13-19 yrs                             0.000211                
2.1%

Males 20+ yrs                               0.000172                
1.7%

Seniors 55+                                 0.000160                
1.6%

Children 1-2 yrs                            0.000698                
7.0%

Children 3-5 yrs                            0.000541                
5.4%

Children 6-12 yrs                           0.000339                
3.4%

Youth 13-19 yrs                             0.000190                
1.9%

Adults 20-49 yrs                            0.000168                
1.7%

Adults 50+ yrs                              0.000160                
1.6%

Females 13-49 yrs                           0.000161                
1.6%

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

 PAGE   14 

Page   PAGE  1  of   NUMPAGES  13