Number range CHAPTER![](media/image1.png){width="0.8in" height="0.8in"}

**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

**[MEMORANDUM]{.underline}**

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 (95^th^ 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: <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]{.underline}: 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:

[]{.mark}

  ----------------------- ----------- ----------------------- ------------
  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,  0.06 ppm
                                      except liver            

  Aspirated grain         0.40 ppm    Goat, liver             0.35 ppm
  fractions                                                   

  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, 0.06 ppm
                                      except liver            

  Oat, hay                0.50 ppm    Sheep, liver            0.35 ppm

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

  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           0.02 ppm
                                      byproducts              

  Cattle, fat             0.02 ppm    Eggs                    0.02 ppm

  Cattle, meat            0.06 ppm                            
  byproducts, except                                          
  liver                                                       
  ----------------------- ----------- ----------------------- ------------

[Nature of the Residue]{.underline}:

*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]{.underline}: 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:]{.underline} For the acute and chronic
assessments, it was assumed that 100% of the proposed crops have been
treated with pyrasulfotole.

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

[]{.mark}

[Processing Factors:]{.underline} 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.

+---------+--------+-------------+-----------------+-----------------+
| **T     |        |             |                 |                 |
| able 1. |        |             |                 |                 |
| Summary |        |             |                 |                 |
| of      |        |             |                 |                 |
| Toxico  |        |             |                 |                 |
| logical |        |             |                 |                 |
| Doses   |        |             |                 |                 |
| and     |        |             |                 |                 |
| En      |        |             |                 |                 |
| dpoints |        |             |                 |                 |
| for     |        |             |                 |                 |
| Pyrasu  |        |             |                 |                 |
| lfotole |        |             |                 |                 |
| for Use |        |             |                 |                 |
| in      |        |             |                 |                 |
| Dietary |        |             |                 |                 |
| Human   |        |             |                 |                 |
| Health  |        |             |                 |                 |
| Risk    |        |             |                 |                 |
| Assessm |        |             |                 |                 |
| ents.** |        |             |                 |                 |
+---------+--------+-------------+-----------------+-----------------+
| **E     | *      | **Uncer     | **RfD, PAD,     | **Study and     |
| xposure | *Point | tainty/FQPA | Level of        | Relevant        |
| Sce     | of     | Safety      | Concern for     | Toxicological   |
| nario** | Depar  | Factors**   | Risk            | Effects**       |
|         | ture** |             | Assessment**    |                 |
+---------+--------+-------------+-----------------+-----------------+
| Acute   | NOAEL  | UF~A~ = 10X | aRfD = aPAD =   | **Developmental |
| Dietary | = 3.8  |             | 0.038 mg/kg/day | neurotoxicity   |
| (All    |        | UF~H~ = 10X |                 | (rat;           |
| popul   | mg/    |             |                 | dietary)**      |
| ations) | kg/day | UF~FQPA~ =  |                 | Offspring LOAEL |
|         |        | 1X          |                 | = 37 mg/kg/day  |
|         |        |             |                 | based on        |
|         |        |             |                 | delayed         |
|         |        |             |                 | preputial       |
|         |        |             |                 | separation      |
|         |        |             |                 | (males),        |
|         |        |             |                 | decreased       |
|         |        |             |                 | cerebrum length |
|         |        |             |                 | (PND 21         |
|         |        |             |                 | females), and   |
|         |        |             |                 | decreased       |
|         |        |             |                 | cerebellum      |
|         |        |             |                 | height (PND 21  |
|         |        |             |                 | males)          |
+---------+--------+-------------+-----------------+-----------------+
| Chronic | NOAEL  | UF~A~ = 10X | cRfD = cPAD =   | **Combined      |
| Dietary | = 1.0  |             | 0.01mg/kg/day   | chronic         |
| (All    |        | UF~H~ = 10X |                 | toxicity/       |
| popul   | mg/    |             |                 | carcinogenicity |
| ations) | kg/day | UF~FQPA~ =  |                 | (rat;           |
|         |        | 1X          |                 | dietary)**      |
|         |        |             |                 | LOAEL = 10/14   |
|         |        |             |                 | mg/kg/day (M/F) |
|         |        |             |                 | based on        |
|         |        |             |                 | corneal         |
|         |        |             |                 | opacity,        |
|         |        |             |                 | neo             |
|         |        |             |                 | vascularization |
|         |        |             |                 | 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  | Cla    |             |                 |                 |
| (oral,  | ssific |             |                 |                 |
| dermal, | ation: |             |                 |                 |
| inha    | "Sugg  |             |                 |                 |
| lation) | estive |             |                 |                 |
|         | Ev     |             |                 |                 |
|         | idence |             |                 |                 |
|         | of     |             |                 |                 |
|         | Carcin |             |                 |                 |
|         | ogenic |             |                 |                 |
|         | Pote   |             |                 |                 |
|         | ntial" |             |                 |                 |
|         | based  |             |                 |                 |
|         | on     |             |                 |                 |
|         | inc    |             |                 |                 |
|         | reased |             |                 |                 |
|         | inci   |             |                 |                 |
|         | dences |             |                 |                 |
|         | of     |             |                 |                 |
|         | c      |             |                 |                 |
|         | orneal |             |                 |                 |
|         | tumors |             |                 |                 |
|         | in     |             |                 |                 |
|         | male   |             |                 |                 |
|         | rats   |             |                 |                 |
|         | (car   |             |                 |                 |
|         | cinoge |             |                 |                 |
|         | nicity |             |                 |                 |
|         | study) |             |                 |                 |
|         | and    |             |                 |                 |
|         | u      |             |                 |                 |
|         | rinary |             |                 |                 |
|         | b      |             |                 |                 |
|         | ladder |             |                 |                 |
|         | tumors |             |                 |                 |
|         | in     |             |                 |                 |
|         | male   |             |                 |                 |
|         | and    |             |                 |                 |
|         | female |             |                 |                 |
|         | mice   |             |                 |                 |
|         | (car   |             |                 |                 |
|         | cinoge |             |                 |                 |
|         | nicity |             |                 |                 |
|         | study) |             |                 |                 |
+---------+--------+-------------+-----------------+-----------------+

^1^ UF = uncertainty factor, UF~A~ = extrapolation from animal to human
(interspecies), UF~H~ = potential variation in sensitivity among members
of the human population (intraspecies), UF~FQPA~ = 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**

HED's level of concern is when the exposure is greater than 100% of the
PAD. That is, estimated exposures above this level are of concern, while
estimated exposures at or below this level are not of concern. The
DEEM-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.

[]{.mark}

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 (95^th^ 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.

[]{.mark}

+-----------------+-------------+--------+--------------+------------+
| **Table 2.      |             |        |              |            |
| Summary of      |             |        |              |            |
| Dietary         |             |        |              |            |
| Exposure and    |             |        |              |            |
| Risk for        |             |        |              |            |
| P               |             |        |              |            |
| yrasulfotole.** |             |        |              |            |
+=================+=============+========+==============+============+
| **Population**  | **Acute     |        | **Chronic    |            |
|                 | D           |        | Dietary^2^** |            |
| **Subgroup**    | ietary^1^** |        |              |            |
+-----------------+-------------+--------+--------------+------------+
|                 | **Dietary   | **%    | **Dietary    | **% cPAD** |
|                 | Exposure**  | aPAD** | Exposure**   |            |
|                 |             |        |              |            |
|                 | **(m        |        | **(          |            |
|                 | g/kg/day)** |        | mg/kg/day)** |            |
+-----------------+-------------+--------+--------------+------------+
| U.S. Population | 0.000633    | 2      | 0.000224     | 2          |
| (total)         |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| All Infants (\< | 0.001259    | 3      | 0.000410     | 4          |
| 1 year old)     |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| **Children 1-2  | *           | **4**  | **0.000698** | **7**      |
| years old**     | *0.001393** |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| Children 3-5    | 0.001053    | 3      | 0.000541     | 5          |
| years old       |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| Children 6-12   | 0.000691    | 2      | 0.000339     | 3          |
| years old       |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| Youth 13-19     | 0.000431    | 1      | 0.000190     | 2          |
| years old       |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| Adults 20-49    | 0.000378    | 1      | 0.000168     | 2          |
| years old       |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| Adults 50+      | 0.000331    | 1      | 0.000160     | 2          |
| years old       |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| Females 13-49   | 0.000368    | 1      | 0.000161     | 2          |
| years old       |             |        |              |            |
+-----------------+-------------+--------+--------------+------------+
| ^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**

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 (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

**Attachment 3: Residue File for Chronic DEEM-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

**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\\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

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
\-\-\-\-\-\-\-\-\-\-\-\-- \-\-\-\-\-\-\-\-\-\-\-\-\-\--

U.S. Population (total) 0.000224 2.2%

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%

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--