![](media/image1.png){width="1.1in"
height="1.0638888888888889in"}**UNITED STATES ENVIRONMENTAL PROTECTION
AGENCY**

WASHINGTON, D.C. 20460

+-----------------------------------------------------------------------+
| OFFICE OF                                                             |
|                                                                       |
| PREVENTION, PESTICIDES,                                               |
|                                                                       |
| AND TOXIC SUBSTANCES                                                  |
+-----------------------------------------------------------------------+

########### 

########### 

########### 

########### MEMORANDUM

Date: February 28, 2006

Subject: TCMTB. Acute and Chronic Dietary Exposure Assessments for the
Reregistration Eligibility Decision (RED) Document.

DP Barcode: D324018 PC Code: 127201

40 CFR §: 180.288 Chemical Class: Benzothiazole

From: Samuel Ary, Chemist

Reregistration Branch II

Health Effects Division (7509C)

Through: David E. Hrdy, Biologist

> Jennifer R. Tyler, Chemist
>
> Dietary Exposure Science Advisory Council (DESAC)
>
> Health Effects Division (7509C)

William Hazel, Branch Chief

Reregistration Branch II

Health Effects Division (7509C)

To: Deborah C. Smegal, Risk Assessor

Reregistration Branch I

Health Effects Division (7509C)

Kathryn Avivah Jakob, Chemical Review Manager

Regulatory Management Branch II

Antimicrobial Division (7510C)

**Executive Summary**

Acute and chronic dietary (food and water) exposure assessments were
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which uses
food consumption data from the USDA's Continuing Surveys of Food Intakes
by Individuals (CSFII) from 1994-1996 and 1998. The acute and chronic
dietary risk assessments were conducted for all supported TCMTB food
uses and were performed to support the reregistration eligibility
decision (RED) document.

As an antimicrobial pesticide, TCMTB \[(2-benzothiazolylthio)methyl
thiocyanate\] is used largely as a wood preservative. It is also used as
a microbiocide/microbiostat and bacteriocide/bacteriostat in industrial
processes and water system, as well as in industrial materials, as a
preservative. As an agricultural pesticide, TCMTB is a fungicide used as
a seed treatment on barley, corn, cottonseed, oats, rice, safflower,
sorghum, sugar beets, and wheat.

The reregistration of TCMTB is being supported by Bayer CropScience
(Bayer) and Wilbur-Ellis Company (Wilbur-Ellis). TCMTB food/feed end-use
products are marketed in the United States under the trade names
Busan^®^, Cotguard^®^, Nusan^®^, and Nu-Flow^®^. The Bayer and
Wilbur-Ellis TCMTB formulations registered for food/feed uses include
emulsifiable concentrate (EC) and soluble concentrate (SC). For
food/feed uses, Bayer is supporting TCMTB use on cotton only, while
Wilbur-Ellis is supporting uses on barley, oats, rice, wheat, safflower,
cotton, and sugar beets. The technical registrant of TCMTB, Buckman
Laboratories, Inc. (Buckman), has requested cancellation of all
food/feed uses. Bayer and Wilbur-Ellis will be responsible for providing
the Agency with the appropriate data needed to maintain there supported
uses on their product labels.

Tolerances are established for residues of the fungicide
2-(thiocyanomethylthio)benzothiazole in/on barley (grain and straw),
sugar beets (roots and tops), corn (forage, grain, and stover), cotton
(forage and undelinted seed), oats (forage, grain, hay, and straw), rice
(grain and straw), safflower (seed), sorghum grain (forage, grain, and
stover), and wheat (forage, grain, hay, and straw) at 40 CFR §180.288.
The permanent tolerances for residues in plant commodities are
established at the limit of detection (LOD) of 0.10 ppm.

[Acute Dietary Exposure Results and Characterization of Input
Data]{.underline}

A conservative acute dietary exposure assessment was conducted to
estimate the dietary risks associated with the reregistration of TCMTB.
The acute dietary exposure assessment incorporated maximum theoretical
concentration factors for all commodities, existing tolerance level
residues, 100% crop treated, and the FQPA Index Reservoir Screening Tool
(FIRST) estimated peak drinking water concentration. Acute dietary risk
estimates are provided for the general U.S. population and various
population subgroups, with the major emphasis placed on the exposure
estimates for infants and children. However, an endpoint for females
13-49 years old was not identified in the available toxicity database
for TCMTB; therefore, a separate dietary risk estimate for females 13-49
years old is not provided in this assessment. This assessment concludes
that for all supported commodities, the [acute dietary risk estimates do
not exceed HED's level of concern]{.underline} (less than 100% of the
aPAD) at the 95^[th]{.underline}^ exposure percentile for the U.S.
population (less than 1% of the aPAD) and all population subgroups, with
the highest exposed population subgroup being children 3-5 years old at
2% of the aPAD.

[Chronic Dietary Exposure Results and Characterization of Input
Data]{.underline}

A conservative chronic dietary exposure assessment was conducted to
estimate the dietary risks associated with the reregistration of TCMTB.
The chronic dietary exposure assessment incorporated maximum theoretical
concentration factors for all commodities, existing tolerance level
residues, 100% crop treated, and the FIRST estimated mean drinking water
concentration. Chronic dietary risk estimates are provided for the
general U.S. population and various population subgroups, with the major
emphasis placed on the exposure estimates for infants and children.
However, an endpoint for females 13-49 years old was not identified in
the available toxicity database for TCMTB; therefore, a separate dietary
risk estimate for females 13-49 years old is not provided in this
assessment. This assessment concludes that for all supported
commodities, the [chronic dietary risk estimates do not exceed HED's
level of concern]{.underline} (less than 100% of the cPAD) for the U.S.
population (7% of the cPAD) and all population subgroups, with the
highest exposed population subgroup being children 3-5 years old at 17%
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 the Health Effects Division 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 the Reference
Dose (RfD) divided by the special FQPA Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD. References which discuss
the acute and chronic dietary risk assessments in more detail are
available on the EPA pesticides web site: "Available Information on
Assessing Exposure from Pesticides, A User's Guide," 6/21/2000, web
link:
[[http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf]{.underline}](http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf);
or see SOP 99.6 (8/20/1999).

**II. Residue Information**

The Risk Assessment Review Committee (RARC) met and determined that the
interim residue of concern for tolerance expression and risk assessment
is TCMTB in/on plants (P. Deschamp, Report of the RARC, 1/11/2006). This
is a preliminary decision dependent on the results from the requested
confirmatory metabolism data. Metabolism data depicting the nature of
residues in wheat, cotton, and sugar beets are requested. For drinking
water, the RARC decided that the residues of concern for risk assessment
are TCMTB and 2-MBT. Summary of the decisions concerning the residues of
concern in plants and drinking water are presented below in Table 1.

  -------------------------------------------------------------------------------
  **Table 1.                                                 
  Summary of                                                 
  TCMTB Residues                                             
  to be Included                                             
  in the Risk                                                
  Assessment and                                             
  Tolerance                                                  
  Expression.**                                              
  --------------- --------------------- -------------------- --------------------
  Matrix                                Residues Included in Residues Included in
                                        Risk Assessment      Tolerance Expression

  Plants          Primary crop -        TCMTB                TCMTB
                  barley, cotton, oat,                       
                  rice, safflower,                           
                  sugar beet, and wheat                      

                  Rotational crop       NA = not applicable  NA

  Livestock       Ruminant              NA                   NA

                  Poultry               NA                   NA

  Drinking water                        TCMTB and 2-MBT      NA
  -------------------------------------------------------------------------------

[Residue Data used for Acute and Chronic Dietary
Assessments]{.underline}

Tolerance level residues of 0.10 ppm were incorporated into the acute
and chronic assessments for all commodities.

[Processing Factors]{.underline}

No processing studies are available for TCMTB; therefore, maximum
theoretical concentration factors were used for all commodities (OPPTS
Guideline 860.1520). For a complete list of all processing factors
incorporated into the acute and chronic assessments please see
attachment 1.

[Usage Information]{.underline}

No usage data are available for TCMTB, so 100% crop treated was assumed
for all commodities.

III. **Drinking Water Data**

The drinking water values used in the dietary risk assessment were
provided by the

Environmental Fate and Effects Division (EFED) in the following
memorandum: "Drinking

Water Assessment for the Use of the Fungicide of TCMTB as a Seed
Treatment on Cotton,

Wheat, Barley, Oats, Rice, Sugar Beets, and Safflower" (J. Lin, D324010,
1/31/06).

The estimated drinking water concentrations are calculated using the
FIRST (version 1.0; Aug. 1, 2001) screening model to assess estimated
concentrations of the sum of TCMTB and all potential degradates in
surface water. The highest rate of 0.041 lb ai/A (safflower scenario) is
used for calculating the drinking water concentrations. The model and
its description are available at the EPA internet site:
[http://www.epa.gov/oppefed1/models/water/]{.underline}.

Results from FIRST indicate that the peak (acute) concentration of TCMTB
and degradates is not likely to exceed 0.94 g/L (ppb), and that the
average annual (chronic) concentration is not likely to exceed 0.67 g/L
(ppb).

IV. **DEEM-FCID™ Program and Consumption Information**

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

+-------------+------------+---+-------------+---------------------------+
| **Table 2.  |            |   |             |                           |
| Summary of  |            |   |             |                           |
| To          |            |   |             |                           |
| xicological |            |   |             |                           |
| Dose and    |            |   |             |                           |
| Endpoints   |            |   |             |                           |
| for         |            |   |             |                           |
| TC          |            |   |             |                           |
| MTB.^1,2^** |            |   |             |                           |
+=============+============+===+=============+===========================+
| *           | **Dose     | * |             | **Study and Toxicological |
| *Exposure** | Used in    | * |             | Effects**                 |
|             | Risk       | T |             |                           |
| *           | Assessment | a |             |                           |
| *Scenario** | (mg        | r |             |                           |
|             | /kg/day)** | g |             |                           |
|             |            | e |             |                           |
|             |            | t |             |                           |
|             |            | M |             |                           |
|             |            | O |             |                           |
|             |            | E |             |                           |
|             |            | s |             |                           |
|             |            | / |             |                           |
|             |            | U |             |                           |
|             |            | F |             |                           |
|             |            | s |             |                           |
|             |            | F |             |                           |
|             |            | Q |             |                           |
|             |            | P |             |                           |
|             |            | A |             |                           |
|             |            | s |             |                           |
|             |            | a |             |                           |
|             |            | f |             |                           |
|             |            | e |             |                           |
|             |            | t |             |                           |
|             |            | y |             |                           |
|             |            | f |             |                           |
|             |            | a |             |                           |
|             |            | c |             |                           |
|             |            | t |             |                           |
|             |            | o |             |                           |
|             |            | r |             |                           |
|             |            | f |             |                           |
|             |            | o |             |                           |
|             |            | r |             |                           |
|             |            | R |             |                           |
|             |            | i |             |                           |
|             |            | s |             |                           |
|             |            | k |             |                           |
|             |            | A |             |                           |
|             |            | s |             |                           |
|             |            | s |             |                           |
|             |            | e |             |                           |
|             |            | s |             |                           |
|             |            | s |             |                           |
|             |            | m |             |                           |
|             |            | e |             |                           |
|             |            | n |             |                           |
|             |            | t |             |                           |
|             |            | * |             |                           |
|             |            | * |             |                           |
+-------------+------------+---+-------------+---------------------------+
| Acute       | NOAEL=     | U |             | Developmental toxicity    |
| Dietary     | 25.1       | F |             | study in rats (MRID       |
|             | mg/kg/day  | = |             | 00154295, 92179009        |
| (general    |            | 1 |             | (1985))                   |
| population  | (21 mg     | 0 |             |                           |
| including   | ai/kg/day) | 0 |             | Maternal LOAEL = 76.5 mg  |
| infants and |            | ( |             | TCMTB/kg/day (64 mg       |
| children)   | 83.55% ai  | 1 |             | ai/kg/day), based on      |
|             | purity     | 0 |             | clinical signs of         |
|             |            | x |             | toxicity (ventral         |
|             |            | i |             | alopecia, rough coat,     |
|             |            | n |             | dyspnea/wheezing, oral    |
|             |            | t |             | discharge, diarrhea/loose |
|             |            | e |             | stool, urine staining,    |
|             |            | r |             | piloerection, and hunched |
|             |            | - |             | gait).                    |
|             |            | a |             |                           |
|             |            | n |             |                           |
|             |            | d |             |                           |
|             |            | i |             |                           |
|             |            | n |             |                           |
|             |            | t |             |                           |
|             |            | r |             |                           |
|             |            | a |             |                           |
|             |            | - |             |                           |
|             |            | s |             |                           |
|             |            | p |             |                           |
|             |            | e |             |                           |
|             |            | c |             |                           |
|             |            | i |             |                           |
|             |            | e |             |                           |
|             |            | s |             |                           |
|             |            | e |             |                           |
|             |            | x |             |                           |
|             |            | t |             |                           |
|             |            | r |             |                           |
|             |            | a |             |                           |
|             |            | p |             |                           |
|             |            | o |             |                           |
|             |            | l |             |                           |
|             |            | a |             |                           |
|             |            | t |             |                           |
|             |            | i |             |                           |
|             |            | o |             |                           |
|             |            | n |             |                           |
|             |            | ) |             |                           |
|             |            |   |             |                           |
|             |            | F |             |                           |
|             |            | Q |             |                           |
|             |            | P |             |                           |
|             |            | A |             |                           |
|             |            | S |             |                           |
|             |            | F |             |                           |
|             |            | = |             |                           |
|             |            | 1 |             |                           |
|             |            | x |             |                           |
|             |            |   |             |                           |
|             |            | * |             |                           |
|             |            | * |             |                           |
|             |            | A |             |                           |
|             |            | c |             |                           |
|             |            | u |             |                           |
|             |            | t |             |                           |
|             |            | e |             |                           |
|             |            | P |             |                           |
|             |            | A |             |                           |
|             |            | D |             |                           |
|             |            | * |             |                           |
|             |            | * |             |                           |
|             |            | = |             |                           |
|             |            | 0 |             |                           |
|             |            | . |             |                           |
|             |            | 2 |             |                           |
|             |            | 5 |             |                           |
|             |            |   |             |                           |
|             |            | m |             |                           |
|             |            | g |             |                           |
|             |            | T |             |                           |
|             |            | C |             |                           |
|             |            | M |             |                           |
|             |            | T |             |                           |
|             |            | B |             |                           |
|             |            | / |             |                           |
|             |            | k |             |                           |
|             |            | g |             |                           |
|             |            | / |             |                           |
|             |            | d |             |                           |
|             |            | a |             |                           |
|             |            | y |             |                           |
+-------------+------------+---+-------------+---------------------------+
| Acute       | An         |   |             |                           |
| Dietary     | endpoint   |   |             |                           |
|             | for        |   |             |                           |
| (females    | females    |   |             |                           |
| 13-49)      | 13-49 was  |   |             |                           |
|             | not        |   |             |                           |
|             | identified |   |             |                           |
|             | in the     |   |             |                           |
|             | available  |   |             |                           |
|             | database   |   |             |                           |
|             | for TCMTB. |   |             |                           |
+-------------+------------+---+-------------+---------------------------+
| Chronic     | LOAEL =    |   | UF = 300    | Chronic toxicity study in |
| Dietary     | 3.8        |   | (10x inter- | dogs (MRID 41342201,      |
|             | mg/kg/day  |   | and         | 92179008 (1989))          |
| (all        |            |   | in          |                           |
| p           | 81.6% ai   |   | tra-species | LOAEL = 3.8 mg/kg/day     |
| opulations) | purity     |   | ext         | (males), based on         |
|             |            |   | rapolation, | decreased body weight     |
|             |            |   | 3x for use  | gain, decreased white     |
|             |            |   | of a LOAEL) | cells, monocytes, and     |
|             |            |   |             | plasma ALT; decreased     |
|             |            |   | FQPA SF =   | uterine weight in         |
|             |            |   | 1x          | females.                  |
|             |            |   |             |                           |
|             |            |   | **Chronic   |                           |
|             |            |   | PAD** =     |                           |
|             |            |   | 0.01 mg     |                           |
|             |            |   | ai/kg/day   |                           |
+-------------+------------+---+-------------+---------------------------+
| Carc        | The CPRC   |   |             |                           |
| inogenicity | concluded  |   |             |                           |
|             | that TCMTB |   |             |                           |
|             | should be  |   |             |                           |
|             | classified |   |             |                           |
|             | as Group   |   |             |                           |
|             | C -        |   |             |                           |
|             | possible   |   |             |                           |
|             | human      |   |             |                           |
|             | ca         |   |             |                           |
|             | rcinogen - |   |             |                           |
|             | and        |   |             |                           |
|             | r          |   |             |                           |
|             | ecommended |   |             |                           |
|             | that for   |   |             |                           |
|             | the        |   |             |                           |
|             | purpose of |   |             |                           |
|             | risk       |   |             |                           |
|             | charact    |   |             |                           |
|             | erization, |   |             |                           |
|             | the        |   |             |                           |
|             | Reference  |   |             |                           |
|             | Dose (RfD) |   |             |                           |
|             | approach   |   |             |                           |
|             | should be  |   |             |                           |
|             | used for   |   |             |                           |
|             | qu         |   |             |                           |
|             | antitation |   |             |                           |
|             | of human   |   |             |                           |
|             | risk. This |   |             |                           |
|             | was based  |   |             |                           |
|             | on         |   |             |                           |
|             | sta        |   |             |                           |
|             | tistically |   |             |                           |
|             | s          |   |             |                           |
|             | ignificant |   |             |                           |
|             | increases  |   |             |                           |
|             | in tumors  |   |             |                           |
|             | in both    |   |             |                           |
|             | sexes of   |   |             |                           |
|             | the        |   |             |                           |
|             | Spra       |   |             |                           |
|             | gue-Dawley |   |             |                           |
|             | rat:       |   |             |                           |
|             | testicular |   |             |                           |
|             | in         |   |             |                           |
|             | terstitial |   |             |                           |
|             | cell       |   |             |                           |
|             | adenomas   |   |             |                           |
|             | in males   |   |             |                           |
|             | and        |   |             |                           |
|             | thyroid    |   |             |                           |
|             | c-cell     |   |             |                           |
|             | adenomas   |   |             |                           |
|             | in         |   |             |                           |
|             | females.   |   |             |                           |
+-------------+------------+---+-------------+---------------------------+

1\. *2-(Thiocyanomethylthio) benzothiazole* (TCMTB) - Report of the
Antimicrobials Division Toxicity Endpoint Selection Committee (ADTC).
From: T. McMahon and M. Centra of the Antimicrobials Division (7510C),
PC Code: 035603, January 12, 2005.

2\. UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL
= no observed adverse effect level, LOAEL = lowest observed adverse
effect level, PAD = population adjusted dose (a = acute, c = chronic)
RfD = reference dose, MOE = margin of exposure, LOC = level of concern,
NA = Not Applicable.

***NOTE:*** The Special FQPA Safety Factor recommended by the ADTC
**assumes** that the exposure databases (dietary food, drinking water,
and residential) are complete and that the risk assessment for each
potential exposure scenario includes all metabolites and/or degradates
of concern and does not underestimate the potential risk for infants and
children.

**VI. Results/Discussion**

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

[Results of Acute Dietary Exposure Analysis]{.underline}

This assessment concludes that for all supported commodities, the [acute
dietary risk estimates do not exceed HED's level of concern]{.underline}
(less than 100% of the aPAD) at the 95^[th]{.underline}^ exposure
percentile for the U.S. population (less than 1% of the aPAD) and all
population subgroups, with the highest exposed population subgroup being
all infants less than one years old at 7% of the aPAD. The results of
the acute dietary exposure analysis at the 95^th^, 99^th^, and 99.9^th^
percentiles of exposure are reported in Table 3. The results of the
acute dietary exposure analysis at the 95^th^ percentile are reported in
Table 4 along with chronic dietary exposure analyses for easy
comparison.

  ------------------------------------------------------------------------------------------------------------
  **Table 3. Results                                                                                 
  of Acute (Food and                                                                                 
  Water) Dietary                                                                                     
  Exposure Analysis                                                                                  
  for TCMTB Using                                                                                    
  DEEM-FCID.^1,2^**                                                                                  
  ------------------- ------------- -------------- --------- -------------- --------- -------------- ---------
  Population Subgroup aPAD          95^th^                   99^th^                   99.9^th^       
                      (mg/kg/day)   Percentile               Percentile               Percentile     

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

  General U.S.        0.25          0.002430       0.97      0.003992       1.6       0.006732       2.7
  Population                                                                                         

  All Infants (\< 1   0.25          0.003256       1.3       0.005395       2.2       **0.017325**   **6.9**
  year old)                                                                                          

  Children 1-2 years  0.25          0.004467       1.8       **0.006779**   **2.7**   0.010134       4.1
  old                                                                                                

  Children 3-5 years  0.25          **0.004581**   **1.8**   0.006450       2.6       0.010247       4.1
  old                                                                                                

  Children 6-12 years 0.25          0.003370       1.4       0.005086       2.0       0.007745       3.1
  old                                                                                                

  Youth 13-19 years   0.25          0.002109       0.84      0.003324       1.3       0.004994       2.0
  old                                                                                                

  Adults 20-49 years  0.25          0.001547       0.62      0.002258       0.90      0.003428       1.4
  old                                                                                                

  Adults 50+ years    0.25          0.001192       0.48      0.001810       0.72      0.003464       1.4
  old                                                                                                

  Females 13-49 years 0.25          0.001529       0.61      0.002345       0.94      0.003411       1.4
  old                                                                                                
  ------------------------------------------------------------------------------------------------------------

1\. The **bolded** values represent the highest exposed populations for
each percentile.

2\. NA = Not applicable.

[Results of Chronic Dietary Exposure Analysis]{.underline}

This assessment concludes that for all supported commodities, the
[chronic dietary risk estimates do not exceed HED's level of
concern]{.underline} (less than 100% of the cPAD) for the U.S.
population (7% of the cPAD) and all population subgroups, with the
highest exposed population subgroup being children 3-5 years old at 17%
of the cPAD. The results of the chronic dietary exposure analysis are
reported below in Table 4.

  ------------------------------------------------------------------------------------------------
  **Table 4. Results                                                                      
  of Acute and                                                                            
  Chronic (Food and                                                                       
  Water) Dietary                                                                          
  Exposure Analyses                                                                       
  for TCMTB Using                                                                         
  DEEM-FCID.^1,2^**                                                                       
  ------------------- ------------- -------------- --------- ------------- -------------- --------
  Population Subgroup aPAD          Acute Dietary            cPAD          Chronic        
                      (mg/kg/day)   (95^th^                  (mg/kg/day)   Dietary        
                                    Percentile)                                           

                                    Exposure       \% aPAD                 Exposure       \% cPAD
                                    (mg/kg/day)                            (mg/kg.day)    

  General U.S.        0.25          0.002430       0.97      0.013         0.000888       6.8
  Population                                                                              

  All Infants (\< 1   0.25          0.003256       1.3       0.013         0.000994       7.6
  year old)                                                                               

  Children 1-2 years  0.25          0.004467       1.8       0.013         0.002054       16
  old                                                                                     

  Children 3-5 years  0.25          **0.004581**   **1.8**   0.013         **0.002226**   **17**
  old                                                                                     

  Children 6-12 years 0.25          0.003370       1.4       0.013         0.001625       13
  old                                                                                     

  Youth 13-19 years   0.25          0.002109       0.84      0.013         0.000936       7.2
  old                                                                                     

  Adults 20-49 years  0.25          0.001547       0.62      0.013         0.000680       5.2
  old                                                                                     

  Adults 50+ years    0.25          0.001192       0.48      0.013         0.000542       4.2
  old                                                                                     

  Females 13-49 years 0.25          0.001529       0.61      0.013         0.000671       5.2
  old                                                                                     
  ------------------------------------------------------------------------------------------------

1\. The **bolded** values represent the highest exposed populations for
each percentile.

2\. NA = Not applicable.

**VII. Characterization of Inputs/Outputs**

The acute and chronic dietary exposure assessments are refined through
the use of theoretically determined processing factors. Tolerance values
were used for all commodities in the acute and chronic dietary exposure
assessments and 100% crop treated was assumed for all commodities. HED
concludes that the exposure estimates provided in this document likely
overestimate actual exposure.

**VIII. Conclusions**

The acute and chronic dietary risk assessments were conducted for all
supported TCMTB food uses and were performed to support the RED
document. The acute and chronic assessments show that dietary (including
drinking water) exposure and risk are not of concern for the supported
uses.

**IX. List of Attachments**

Attachment 1. Data and Residue Estimates Used in Dietary Analyses.

Attachment 2. Acute Food and Water Residue Input File.

Attachment 3. Acute Food and Water Results File.

Attachment 4. Chronic Food and Water Residue Input File.

Attachment 5. Chronic Food and Water Results File.

+--------------+--------+------+-----+-----+-------+--------+--------+
| **A          |        |      |     |     |       |        |        |
| ttachment 1. |        |      |     |     |       |        |        |
| Data and     |        |      |     |     |       |        |        |
| Residue      |        |      |     |     |       |        |        |
| Estimates    |        |      |     |     |       |        |        |
| Used in      |        |      |     |     |       |        |        |
| Dietary      |        |      |     |     |       |        |        |
| Analyses.**  |        |      |     |     |       |        |        |
+==============+========+======+=====+=====+=======+========+========+
| RAC^1^       | Class  | Data | \%  | \%  | Proce | Antic  |        |
|              | ificat | So   | CT  | CT  | ssing | ipated |        |
|              | ion^2^ | urce | A   | M   | Fa    | R      |        |
|              |        |      | vg. | ax. | ctors | esidue |        |
|              |        |      | ^3^ | ^3^ |       | E      |        |
|              |        |      |     |     |       | stimat |        |
|              |        |      |     |     |       | es/Tol |        |
|              |        |      |     |     |       | erance |        |
+--------------+--------+------+-----+-----+-------+--------+--------+
|              |        |      |     |     |       | Acute  | C      |
|              |        |      |     |     |       | (Tol,  | hronic |
|              |        |      |     |     |       | AR,    | (Tol,  |
|              |        |      |     |     |       | RDF)   | AR)    |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Barley,      | B      | T    | 100 | 100 | Bran  | Tol    | Tol    |
| grain        |        | oler |     |     | 7.7x  | (0.10  | (0.1   |
|              |        | ance |     |     |       | ppm)   | ppm)   |
|              |        |      |     |     | Pe    |        |        |
|              |        |      |     |     | arled |        |        |
|              |        |      |     |     | 1.2x  |        |        |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Beet, sugar, | B      | T    | 100 | 100 | Sugar | Tol    | Tol    |
| root         |        | oler |     |     | 12.5x | (0.10  | (0.10  |
|              |        | ance |     |     |       | ppm)   | ppm)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Corn, field, | B      | T    | 100 | 100 | Oil   | Tol    | Tol    |
| grain        |        | oler |     |     | 25x   | (0.10  | (0.10  |
|              |        | ance |     |     |       | ppm)   | ppm)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Cotton,      | B      | T    | 100 | 100 | Oil   | Tol    | Tol    |
| undelinted   |        | oler |     |     | 6.3x  | (0.10  | (0.10  |
| seed         |        | ance |     |     |       | ppm)   | ppm)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Oat, grain   | B      | T    | 100 | 100 | R     | Tol    | Tol    |
|              |        | oler |     |     | olled | (0.10  | (0.10  |
|              |        | ance |     |     | 1.4x  | ppm)   | ppm)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Rice, grain  | B      | T    | 100 | 100 | Bran  | Tol    | Tol    |
|              |        | oler |     |     | 7.7x  | (0.10  | (0.10  |
|              |        | ance |     |     |       | ppm)   | ppm)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Safflower,   | B      | T    | 100 | 100 | Oil   | Tol    | Tol    |
| seed         |        | oler |     |     | 3.3x  | (0.10  | (0.10  |
|              |        | ance |     |     |       | ppm)   | ppm)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Water        | NA     | EDWC | NA  | NA  | NA    | AR     | AR     |
|              |        | s^4^ |     |     |       | (0.94  | (0.67  |
|              |        |      |     |     |       | ppb)   | ppb)   |
+--------------+--------+------+-----+-----+-------+--------+--------+
| Wheat, grain | B      | T    | 100 | 100 | Bran  | Tol    | Tol    |
|              |        | oler |     |     | 7.7x  | (0.10  | (0.10  |
|              |        | ance |     |     |       | ppm)   | ppm)   |
|              |        |      |     |     | Flour |        |        |
|              |        |      |     |     | 1.4x  |        |        |
+--------------+--------+------+-----+-----+-------+--------+--------+

1\. RAC = Raw agricultural commodity.

2\. Classification of blended (B), partially blended (PB), not blended
(NB).

3\. No data were available for percent crop treated, so 100%CT was used
in the dietary assessment.

4\. EDWCs = Estimated Drinking Water Concentrations.

5\. NA = Not applicable.

**Attachment 2. Acute Food and Water Residue Input File.**

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID Acute analysis for TCMTB

Residue file name: C:\\Pesticides\\TCMTB\\Dietary\\TCMTB acute.R98

Analysis Date 02-05-2006 Residue file dated: 02-05-2006/22:02:47/8

Reference dose (aRfD) = 0.25 mg/kg bw/day

Comment: Food and Water

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

EPA Crop Def Res Adj.Factors Comment

Code Grp Food Name (ppm) #1 #2

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

15000250 15 Barley, pearled barley 0.100000 1.200 1.000

15000251 15 Barley, pearled barley-babyfood 0.100000 1.200 1.000

15000260 15 Barley, flour 0.100000 1.000 1.000

15000261 15 Barley, flour-babyfood 0.100000 1.000 1.000

15000270 15 Barley, bran 0.100000 7.700 1.000

01010520 1A Beet, sugar 0.100000 12.500 1.000

01010521 1A Beet, sugar-babyfood 0.100000 12.500 1.000

01010530 1A Beet, sugar, molasses 0.100000 1.000 1.000

01010531 1A Beet, sugar, molasses-babyfood 0.100000 1.000 1.000

15001200 15 Corn, field, flour 0.100000 1.000 1.000

15001201 15 Corn, field, flour-babyfood 0.100000 1.000 1.000

15001210 15 Corn, field, meal 0.100000 1.000 1.000

15001211 15 Corn, field, meal-babyfood 0.100000 1.000 1.000

15001220 15 Corn, field, bran 0.100000 1.000 1.000

15001230 15 Corn, field, starch 0.100000 1.000 1.000

15001231 15 Corn, field, starch-babyfood 0.100000 1.000 1.000

15001240 15 Corn, field, syrup 0.100000 1.000 1.000

15001241 15 Corn, field, syrup-babyfood 0.100000 1.000 1.000

15001250 15 Corn, field, oil 0.100000 25.000 1.000

15001251 15 Corn, field, oil-babyfood 0.100000 25.000 1.000

95001280 O Cottonseed, oil 0.100000 6.300 1.000

95001281 O Cottonseed, oil-babyfood 0.100000 6.300 1.000

15002310 15 Oat, bran 0.100000 1.000 1.000

15002320 15 Oat, flour 0.100000 1.000 1.000

15002321 15 Oat, flour-babyfood 0.100000 1.000 1.000

15002330 15 Oat, groats/rolled oats 0.100000 1.400 1.000

15002331 15 Oat, groats/rolled oats-babyfood 0.100000 1.400 1.000

15003230 15 Rice, white 0.100000 1.000 1.000

15003231 15 Rice, white-babyfood 0.100000 1.000 1.000

15003240 15 Rice, brown 0.100000 1.000 1.000

15003241 15 Rice, brown-babyfood 0.100000 1.000 1.000

15003250 15 Rice, flour 0.100000 1.000 1.000

15003251 15 Rice, flour-babyfood 0.100000 1.000 1.000

15003260 15 Rice, bran 0.100000 7.700 1.000

15003261 15 Rice, bran-babyfood 0.100000 7.700 1.000

20003300 20 Safflower, oil 0.100000 3.300 1.000

20003301 20 Safflower, oil-babyfood 0.100000 3.300 1.000

86010000 O Water, direct, all sources 0.000940 1.000 1.000

86020000 O Water, indirect, all sources 0.000940 1.000 1.000

15004010 15 Wheat, grain 0.100000 1.000 1.000

15004011 15 Wheat, grain-babyfood 0.100000 1.000 1.000

15004020 15 Wheat, flour 0.100000 1.400 1.000

15004021 15 Wheat, flour-babyfood 0.100000 1.400 1.000

15004030 15 Wheat, germ 0.100000 1.000 1.000

15004040 15 Wheat, bran 0.100000 7.700 1.000

15004050 15 Wild rice 0.100000 1.000 1.000

**Attachment 3. Acute Food and Water Results File.**

U.S. Environmental Protection Agency Ver. 2.02

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

Residue file: TCMTB acute.R98 Adjustment factor #2 used.

Analysis Date: 02-05-2006/22:04:09 Residue file dated:
02-05-2006/22:02:47/8

Daily totals for food and foodform consumption used.

Run Comment: \"Food and Water\"

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

Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD Exposure % aRfD Exposure % aRfD

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

U.S. Population: 0.002430 0.97 0.003992 1.60 0.006732 2.69

All infants: 0.003256 1.30 0.005395 2.16 0.017325 6.93

Children 1-2 yrs: 0.004467 1.79 0.006779 2.71 0.010134 4.05

Children 3-5 yrs: 0.004581 1.83 0.006450 2.58 0.010247 4.10

Children 6-12 yrs: 0.003370 1.35 0.005086 2.03 0.007745 3.10

Youth 13-19 yrs: 0.002109 0.84 0.003324 1.33 0.004994 2.00

Adults 20-49 yrs: 0.001547 0.62 0.002258 0.90 0.003428 1.37

Adults 50+ yrs: 0.001192 0.48 0.001810 0.72 0.003464 1.39

Females 13-49 yrs: 0.001529 0.61 0.002345 0.94 0.003411 1.36

**Attachment 5. Chronic Food and Water Residue Input File.**

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for TCMTB 1994-98 data

Residue file: C:\\Pesticides\\TCMTB\\Dietary\\TCMTB chronic.R98 Adjust.
#2 used

Analysis Date 02-05-2006 Residue file dated: 02-05-2006/22:03:22/8

Reference dose (RfD) = 0.013 mg/kg bw/day

Comment:Food and Water

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

Food Crop Residue Adj.Factors Comment

EPA Code Grp Food Name (ppm)

#1 #2

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

15000250 15 Barley, pearled barley 0.100000 1.200 1.000

15000251 15 Barley, pearled barley-babyfood 0.100000 1.200 1.000

15000260 15 Barley, flour 0.100000 1.000 1.000

15000261 15 Barley, flour-babyfood 0.100000 1.000 1.000

15000270 15 Barley, bran 0.100000 7.700 1.000

01010520 1A Beet, sugar 0.100000 12.500 1.000

01010521 1A Beet, sugar-babyfood 0.100000 12.500 1.000

01010530 1A Beet, sugar, molasses 0.100000 1.000 1.000

01010531 1A Beet, sugar, molasses-babyfood 0.100000 1.000 1.000

15001200 15 Corn, field, flour 0.100000 1.000 1.000

15001201 15 Corn, field, flour-babyfood 0.100000 1.000 1.000

15001210 15 Corn, field, meal 0.100000 1.000 1.000

15001211 15 Corn, field, meal-babyfood 0.100000 1.000 1.000

15001220 15 Corn, field, bran 0.100000 1.000 1.000

15001230 15 Corn, field, starch 0.100000 1.000 1.000

15001231 15 Corn, field, starch-babyfood 0.100000 1.000 1.000

15001240 15 Corn, field, syrup 0.100000 1.000 1.000

15001241 15 Corn, field, syrup-babyfood 0.100000 1.000 1.000

15001250 15 Corn, field, oil 0.100000 25.000 1.000

15001251 15 Corn, field, oil-babyfood 0.100000 25.000 1.000

95001280 O Cottonseed, oil 0.100000 6.300 1.000

95001281 O Cottonseed, oil-babyfood 0.100000 6.300 1.000

15002310 15 Oat, bran 0.100000 1.000 1.000

15002320 15 Oat, flour 0.100000 1.000 1.000

15002321 15 Oat, flour-babyfood 0.100000 1.000 1.000

15002330 15 Oat, groats/rolled oats 0.100000 1.400 1.000

15002331 15 Oat, groats/rolled oats-babyfood 0.100000 1.400 1.000

15003230 15 Rice, white 0.100000 1.000 1.000

15003231 15 Rice, white-babyfood 0.100000 1.000 1.000

15003240 15 Rice, brown 0.100000 1.000 1.000

15003241 15 Rice, brown-babyfood 0.100000 1.000 1.000

15003250 15 Rice, flour 0.100000 1.000 1.000

15003251 15 Rice, flour-babyfood 0.100000 1.000 1.000

15003260 15 Rice, bran 0.100000 7.700 1.000

15003261 15 Rice, bran-babyfood 0.100000 7.700 1.000

20003300 20 Safflower, oil 0.100000 3.300 1.000

20003301 20 Safflower, oil-babyfood 0.100000 3.300 1.000

86010000 O Water, direct, all sources 0.000670 1.000 1.000

86020000 O Water, indirect, all sources 0.000670 1.000 1.000

15004010 15 Wheat, grain 0.100000 1.000 1.000

15004011 15 Wheat, grain-babyfood 0.100000 1.000 1.000

15004020 15 Wheat, flour 0.100000 1.400 1.000

15004021 15 Wheat, flour-babyfood 0.100000 1.400 1.000

15004030 15 Wheat, germ 0.100000 1.000 1.000

15004040 15 Wheat, bran 0.100000 7.700 1.000

15004050 15 Wild rice 0.100000 1.000 1.000

**Attachment 6. Chronic Food and Surface Water Results File.**

U.S. Environmental Protection Agency Ver. 2.00

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

Residue file name: C:\\Pesticides\\TCMTB\\Dietary\\TCMTB chronic.R98

Adjustment factor #2 used.

Analysis Date 02-05-2006/22:12:18 Residue file dated:
02-05-2006/22:03:22/8

Reference dose (RfD, Chronic) = 0.013 mg/kg bw/day

COMMENT 1: Food and Water

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

Total exposure by population subgroup

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

Total Exposure

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

Population mg/kg Percent of

Subgroup body wt/day Rfd

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

U.S. Population (total) 0.000888 6.8%

U.S. Population (spring season) 0.000913 7.0%

U.S. Population (summer season) 0.000879 6.8%

U.S. Population (autumn season) 0.000879 6.8%

U.S. Population (winter season) 0.000884 6.8%

Northeast region 0.000874 6.7%

Midwest region 0.000952 7.3%

Southern region 0.000855 6.6%

Western region 0.000886 6.8%

Hispanics 0.000942 7.2%

Non-hispanic whites 0.000876 6.7%

Non-hispanic blacks 0.000906 7.0%

Non-hisp/non-white/non-black 0.000907 7.0%

All infants (\< 1 year) 0.000994 7.6%

Nursing infants 0.000421 3.2%

Non-nursing infants 0.001212 9.3%

Children 1-6 yrs 0.002140 16.5%

Children 7-12 yrs 0.001548 11.9%

Females 13-19 (not preg or nursing) 0.000840 6.5%

Females 20+ (not preg or nursing) 0.000582 4.5%

Females 13-50 yrs 0.000714 5.5%

Females 13+ (preg/not nursing) 0.000810 6.2%

Females 13+ (nursing) 0.000823 6.3%

Males 13-19 yrs 0.001028 7.9%

Males 20+ yrs 0.000674 5.2%

Seniors 55+ 0.000536 4.1%

Children 1-2 yrs 0.002054 15.8%

Children 3-5 yrs 0.002226 17.1%

Children 6-12 yrs 0.001625 12.5%

Youth 13-19 yrs 0.000936 7.2%

Adults 20-49 yrs 0.000680 5.2%

Adults 50+ yrs 0.000542 4.2%

Females 13-49 yrs 0.000671 5.2%