Document ID: EPA-HQ-OPP-2010-0266-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-04-29T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF CHEMICAL SAFETY AND

                                                                        
                      POLLUTION PREVENTION

	

MEMORANDUM

Date:  		09-FEB-2011  

SUBJECT:	Pyrasulfotole.  Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action for Use on Grain Sorghum and Grass Grown for Seed.

PC Code:  000692  	DP Barcode:  375390   

Decision No.:  425581	Registration No.:  264-1023

Petition No.:  9F7680	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  Dietary Exposure 	Case No.:  7272

TXR No.:  None.	CAS No.:  365400-11-9 

MRID No.:  None.	40 CFR:  180.631

FROM:	Jennifer R. Tyler, Chemist

		Risk Assessment Branch 1 (RAB1)

		Health Effects Division (HED; 7509P)

THROUGH:	Yvonne Barnes, Chemist

		Debra Rate, Ph.D., Biologist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

George F. Kramer, Ph.D., Senior Chemist

		RAB1/HED (7509P)

TO:		Allison Nowotarski, Biologist

		RAB1/HED (7509P)

and

Bethany Benbow/Joanne Miller, RM Team 23

		Registration Division (RD; 7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure
and risk assessments were conducted using the Dietary Exposure
Evaluation Model-Food Commodity Intake Database (DEEM-FCID(; ver. 2.03)
which use food consumption data from the U.S. Department of
Agriculture’s Continuing Surveys of Food Intakes by Individuals
(CSFII) from 1994-1996 and 1998.  No cancer dietary exposure assessment
was performed because pyrasulfotole is not carcinogenic.  The analyses
were performed to support Section 3 requests for use of pyrasulfotole on
grain, sorghum and grass grown for seed.

   

Acute Dietary (Food and Drinking Water) Exposure Results and
Characterization:  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 registered and
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 (3% of the aPAD) and all other populations subgroups.  The
most highly exposed population subgroup is children 1-2 years old at 9%
of the cPAD.

Chronic Dietary (Food and Drinking Water) Exposure Results and
Characterization:  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
registered and 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 (4% of the cPAD) and all population
subgroups.  The most highly exposed population subgroup is children 1-2
years old at 16% of the cPAD.

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.  HED is generally
concerned when estimated cancer risk exceeds one in one million.
References which discuss the acute and chronic risk assessments in more
detail are available on the EPA/pesticides web site:  “Available
Information on Assessing Exposure from Pesticides, A User’s Guide,”
21-JUN-2000, web link:      HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see
SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for pyrasulfotole was conducted
by Jennifer Tyler in conjunction with a Section 3 request for the use of
pyrasulfotole on small cereal grains (Memo, 6/7/07; D333435).

II.	Residue Information

Registered and Proposed Pyrasulfotole Uses:  Tolerances have been
established for residues of pyrasulfotole and pyrasulfotole-desmethyl
in/on small cereal grains, including wheat, barley, oat, rye and
triticale; as well as several livestock commodities (See Table 1; 40 CFR
180.631).  The current petition is for the use of pyrasulfotole on
sorghum and grass grown for seed.  The available residue chemistry
database supports the establishment of the permanent tolerances for
residues of pyrasulfotole and its metabolite pyrasulfotole-desmethyl as
listed in Table 1.

Table 1.  Tolerance Summary for Pyrasulfotole.

Commodity	Current Tolerance (ppm)	Proposed Tolerance (ppm)
HED-Recommended Tolerance (ppm)	Comments

(correct commodity definition)

Wheat, grain	0.02	-	-

	Wheat, straw	0.20	-	-

	Wheat, forage	0.20	-	-

	Wheat, hay	0.80	-	-

	Aspirated grain fractions	0.40	-	-

	Oat, grain	0.08	-	-

	Oat, straw	0.20	-	-

	Oat, forage	0.10	-	-

	Oat, hay	0.50	-	-

	Barley, grain	0.02	-	-

	Barley, straw	0.20	-	-

	Barley, hay	0.30	-	-

	Rye, grain	0.02	-	-

	Rye, straw	0.20	-	-

	Rye, forage	0.20	-	-

	Sorghum, grain	-	0.8	0.70	Sorghum, grain, grain

Sorghum, forage	-	1.2	1.5	Sorghum, grain, forage

Sorghum, stover	-	0.35	0.80	Sorghum, grain, stover

Grass, forage	-	10	25

	Grass, hay	-	2.5	3.5

	Milk*	0.01	0.01	0.03

	Cattle, meat	0.02	0.04	see current tolerance

	Cattle, fat*	0.02	0.04	0.03

	Cattle, meat byproducts*	0.06	2	0.70	Cattle, meat byproducts, except
liver

Cattle, liver*	0.35	8	3.0

	Goat, meat	0.02	0.04	see current tolerance

	Goat, fat*	0.02	0.04	0.03

	Goat, meat byproducts*	0.06	2	0.70	Goat, meat byproducts, except liver

Goat, liver*	0.35	8	3.0

	Hog, meat	0.02	0.04	see current tolerance

	Hog, fat	0.02	0.04	see current tolerance

	Hog, meat byproducts*	0.06	2	0.05	Hog, meat byproducts, except liver

Hog, liver*	-	8	0.30

	Sheep, meat	0.02	0.04	see current tolerance

	Sheep, fat*	0.02	0.04	0.03

	Sheep, meat byproducts*	0.06	2	0.70	Sheep, meat byproducts, except
liver

Sheep, liver*	0.35	8	3.0

	Horse, meat	0.02	0.04	see current tolerance

	Horse, fat*	0.02	0.04	0.03

	Horse, meat byproducts*	0.06	2	0.70	Horse, meat byproducts, except
liver

Horse, liver*	0.35	8	3.0

	Poultry, meat	0.02	-	see current tolerance

	Poultry, fat*	0.02	-	0.03

	Poultry, meat byproducts*	0.02	-	0.20

	Eggs	0.02	-	see current tolerance

	

Nature of the Residue:  For plants and livestock, the residues of
concern for tolerances and risk assessment purposes are pyrasulfotole
and pyrasulfotole-desmethyl (Memo, J. Tyler et al., 6/8/07; D328640). 
The residues of concern in drinking water for risk assessment purposes
are parent only.

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

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

™ 7.81 default processing factors were used for all registered
commodities.

 Drinking Water Data

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 (Memo, C. Peck, 8/4/10; D374622).  The
assessment was based on the proposed grain sorghum 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 6.9 ppb and 4.8 ppb, respectively.  The ground water EDWC for both
acute and chronic exposures in estimated as 2.4 ppb.  Water residues
were incorporated in the DEEM-FCID into the food categories “water,
direct, all sources” and “water, indirect, all sources.”

Table 2.  Summary of Estimated Surface Water and Groundwater EDWCs for
Pyrasulfotole.

	Surface Water Concentration (ppb)a	Groundwater Concentration (ppb)b

Acute	6.9	2.4

Chronic (non-cancer)	4.8	2.4

Chronic (cancer)	-	-

a From the Tier I FIRST model.  Input parameters are based on aerial
spray applications to grain sorghum at a rate of 0.039 lb ai/A/year.

b From the SCI-GROW model assuming a maximum seasonal use rate of 0.039
lb ai/A, a Koc of 20 ml/gOC, and half-life of 226 days.

IV.	DEEM-FCID™ Program and Consumption Information

Pyrasulfotole acute and chronic dietary exposure assessments were
conducted using the 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.  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

A summary of the toxicological doses and endpoints selected for dietary
exposure assessment is provided in Table 3.

Table 3.  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.

VI.	Results/Discussion and Conclusions

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

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis: 
An acute dietary exposure assessment (using tolerance level residues and
100% CT information for all registered and 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 (3% of the aPAD) and all populations
subgroups.  The most highly exposed population subgroup is children 1-2
years old at 9% of the cPAD.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis: 
The chronic dietary exposure assessment (using tolerance level residues
and 100% CT information for all registered and 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 (4% of the
cPAD) and all population subgroups.  The most highly exposed population
subgroup is children 1-2 years old at 16% of the cPAD.

Table 4.  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)	0.001315	3	0.000433	4

All Infants (< 1 year old)	0.002549	7	0.000829	8

Children 1-2 years old	0.003428	9	0.001567	16

Children 3-5 years old	0.002288	6	0.001150	12

Children 6-12 years old	0.001480	4	0.000699	7

Youth 13-19 years old	0.000878	2	0.000352	4

Adults 20-49 years old	0.000695	2	0.000298	3

Adults 50+ years old	0.000616	2	0.000300	3

Females 13-49 years old	0.000698	2	0.000295	3

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.

VII.	Characterization of Inputs/Outputs

These analyses are considered to be conservative dietary exposure
assessments.  Residues were assumed to be equivalent to the tolerance
levels.  Tolerance-level residues should always exceed the residue
levels found on food commodities at the time of consumption.  When field
trials are performed, the maximum allowable application rate is used and
crops are harvested at the minimum preharvest interval (PHI).  Samples
are stored frozen until analysis to ensure minimal degradation of
residues.  In actual practice, however, growers will not usually use the
maximum application rates for economic reasons.  In addition, most crops
are not harvested and immediately stored frozen.  Also, 100% CT was
assumed for all foods.  For these reasons, HED is confident that this
analysis does not underestimate risk to the general U.S. population or
any population subgroup.  Further refinement to the analyses could be
made through the use of monitoring data, %CT data, and additional
empirical processing factors.  Since risk estimates are not of concern
to HED, a more highly refined analysis is not needed at this time.

VIII.	List of Attachments

Attachment 1.  Residue File for Acute 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:  J. Tyler (RAB1)

RDI:  DE SAC [Y. Barnes (10/6/10), D. Rate (10/01/10)], G. Kramer
(2/09/11)

J. Tyler: S-10943: Potomac Yard: (703) 305-5564: RAB1

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

Filename: C:\Documents and Settings\jtyler\My
Documents\JenWork\$Pyrasulfatole\2010\Sorhum and Grass Grown for
Seed\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: 10-06-2010/11:14:23/8          Program ver.
2.03

Comment: Proposed use on grain sorghum and grass grown for seed.  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   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.700000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.700000   1.000  1.000
 

21000470 M    Beef, fat                          0.030000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.030000   1.000  1.000
 

21000480 M    Beef, kidney                       0.700000   1.000  1.000
 

21000490 M    Beef, liver                        3.000000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               3.000000   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                     0.200000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.200000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.200000   1.000  1.000
 

40000960 P    Chicken, fat                       0.030000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.030000   1.000  1.000
 

40000970 P    Chicken, skin                      0.030000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.030000   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              0.700000   1.000  1.000
 

23001710 M    Goat, fat                          0.030000   1.000  1.000
 

23001720 M    Goat, kidney                       0.700000   1.000  1.000
 

23001730 M    Goat, liver                        3.000000   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                          0.030000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.030000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
 

27022240 D    Milk, water                        0.030000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.030000   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              0.050000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.050000   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                       0.050000   1.000  1.000
 

25002950 M    Pork, liver                        0.300000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.020000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.200000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.200000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.030000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.030000   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             0.700000   1.000  1.000
 

26003410 M    Sheep, fat                         0.030000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.030000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.700000   1.000  1.000
 

26003430 M    Sheep, liver                       3.000000   1.000  1.000
 

15003440 15   Sorghum, grain                     0.700000   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                      0.200000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.200000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.200000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.200000   1.000  1.000
 

50003850 P    Turkey, fat                        0.030000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.030000   1.000  1.000
 

50003860 P    Turkey, skin                       0.030000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.030000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.006900   1.000  1.000
 6.9 pp

          Full comment: 6.9 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.006900   1.000  1.000
 6.9 pp

          Full comment: 6.9 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 – All Populations.

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 000692a.R98                             Adjustment factor
#2 used.

Analysis Date: 10-06-2010/13:27:12    Residue file dated:
10-06-2010/11:14:23/8

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

Daily totals for food and foodform consumption used.

Run Comment: "Proposed use on grain sorghum and grass grown for seed. 
FQPA Sa

fety Factor=1x; therefore, 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:

  0.001315    3.46    2888    0.002440    6.42    1557    0.006103  
16.06     622  

All infants:

  0.002549    6.71    1490    0.004861   12.79     781    0.006513  
17.14     583  

Children 1-2 yrs:

  0.003428    9.02    1108    0.004806   12.65     790    0.009023  
23.74     421  

Children 3-5 yrs:

  0.002288    6.02    1661    0.003193    8.40    1189    0.013998  
36.84     271  

Children 6-12 yrs:

  0.001480    3.90    2567    0.002006    5.28    1894    0.004598  
12.10     826  

Youth 13-19 yrs:

  0.000879    2.31    4324    0.001309    3.44    2903    0.002168   
5.70    1753  

Adults 20-49 yrs:

  0.000695    1.83    5470    0.001017    2.68    3737    0.004247  
11.18     894  

Adults 50+ yrs:

  0.000616    1.62    6164    0.000899    2.37    4228    0.006900  
18.16     550  

Females 13-49 yrs:

  0.000698    1.84    5442    0.001050    2.76    3618    0.005506  
14.49     690  

ronic DEEM-FCID™ Analysis.

Filename: C:\Documents and Settings\jtyler\My
Documents\JenWork\$Pyrasulfatole\2010\Sorhum and Grass Grown for
Seed\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: 10-06-2010/11:14:49/8          Program ver.
2.03

Comment:  Proposed use on grain sorghum and grass grown for seed.  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   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.700000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.700000   1.000  1.000
 

21000470 M    Beef, fat                          0.030000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.030000   1.000  1.000
 

21000480 M    Beef, kidney                       0.700000   1.000  1.000
 

21000490 M    Beef, liver                        3.000000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               3.000000   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                     0.200000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.200000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.200000   1.000  1.000
 

40000960 P    Chicken, fat                       0.030000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.030000   1.000  1.000
 

40000970 P    Chicken, skin                      0.030000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.030000   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              0.700000   1.000  1.000
 

23001710 M    Goat, fat                          0.030000   1.000  1.000
 

23001720 M    Goat, kidney                       0.700000   1.000  1.000
 

23001730 M    Goat, liver                        3.000000   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                          0.030000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.030000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
 

27022240 D    Milk, water                        0.030000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.030000   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              0.050000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.050000   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                       0.050000   1.000  1.000
 

25002950 M    Pork, liver                        0.300000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.020000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.200000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.200000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.030000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.030000   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             0.700000   1.000  1.000
 

26003410 M    Sheep, fat                         0.030000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.030000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.700000   1.000  1.000
 

26003430 M    Sheep, liver                       3.000000   1.000  1.000
 

15003440 15   Sorghum, grain                     0.700000   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                      0.200000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.200000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.200000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.200000   1.000  1.000
 

50003850 P    Turkey, fat                        0.030000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.030000   1.000  1.000
 

50003860 P    Turkey, skin                       0.030000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.030000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.004800   1.000  1.000
 4.8 pp

          Full comment: 4.8 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.004800   1.000  1.000
 4.8 pp

          Full comment: 4.8 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
 

Attachment 4:  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\gkramer\My
Documents\Gk\##Temp\000692c.R98

                                                     Adjustment factor
#2 used.

Analysis Date 10-06-2010/13:25:39     Residue file dated:
10-06-2010/11:14:49/8

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

COMMENT 1: Proposed use on grain sorghum and grass grown for seed.  FQPA
safety factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

  h¤ 

됂逃$愂Ĥ摧⑶W

 h¤ 

h¤ 

 h¤ 

 

 



 

 

 

P

R

Z

y

€

‰

Š

—

 

¡

¯

¿

7

Y

€

¡

À

ò

ༀꂄᄅ悄ㇺ$葞֠葠褐摧䎣«ༀ¿

À

 

-

.

;

f

±

²

¿

@

@

@

㓿ۖĀ̊d鐃曽Ĵ瑹䀆½

㓿ۖĀ̊d鐃曽Ĵ瑹䀆½

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

愀Ĥ摧㮒æ

@

ô

@

ô

@

&

&

	ˆ

€

&

	ˆ

€

@

&

@

&

@

&

@

&

	ˆ

€

@

&

	ˆ

€

&

	ˆ

€

&

	ˆ

€

&

	ˆ

€

--

U.S. Population (total)                     0.000433                
4.3%

U.S. Population (spring season)             0.000426                
4.3%

U.S. Population (summer season)             0.000434                
4.3%

U.S. Population (autumn season)             0.000444                
4.4%

U.S. Population (winter season)             0.000426                
4.3%

Northeast region                            0.000426                
4.3%

Midwest region                              0.000454                
4.5%

Southern region                             0.000401                
4.0%

Western region                              0.000467                
4.7%

Hispanics                                   0.000518                
5.2%

Non-hispanic whites                         0.000417                
4.2%

Non-hispanic blacks                         0.000442                
4.4%

Non-hisp/non-white/non-black                0.000468                
4.7%

All infants (< 1 year)                      0.000829                
8.3%

Nursing infants                             0.000281                
2.8%

Non-nursing infants                         0.001037               
10.4%

Children 1-6  yrs                           0.001259               
12.6%

Children 7-12 yrs                           0.000650                
6.5%

Females 13-19 (not preg or nursing)         0.000309                
3.1%

Females 20+ (not preg or nursing)           0.000291                
2.9%

Females 13-50 yrs                           0.000334                
3.3%

Females 13+ (preg/not nursing)              0.000370                
3.7%

Females 13+ (nursing)                       0.000417                
4.2%

Males 13-19 yrs                             0.000392                
3.9%

Males 20+ yrs                               0.000304                
3.0%

Seniors 55+                                 0.000302                
3.0%

Children 1-2 yrs                            0.001567               
15.7%

Children 3-5 yrs                            0.001150               
11.5%

Children 6-12 yrs                           0.000699                
7.0%

Youth 13-19 yrs                             0.000352                
3.5%

Adults 20-49 yrs                            0.000298                
3.0%

Adults 50+ yrs                              0.000300                
3.0%

Females 13-49 yrs                           0.000295                
3.0%

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

	

Pyrasulfotole	Dietary Exposure and Risk Assessment	DP Number: D375390  

PC Code:  000692

________________________________________________________________________
___________________

Page   PAGE  1  of   NUMPAGES  13