Document ID: EPA-HQ-OPP-2006-0320-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-04-26T04:00Z

Page
1
of
13
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
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)
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
2
of
13
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
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
(
less
than
100%
of
the
aPAD)
at
the
95th
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.
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
3
of
13
Chronic
Dietary
Exposure
Results
and
Characterization
of
Input
Data
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
(
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;
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
Risk
Assessment
Residues
Included
in
Tolerance
Expression
Primary
crop
­
barley,
cotton,
oat,
rice,
safflower,
sugar
beet,
and
wheat
TCMTB
TCMTB
Plants
Rotational
crop
NA
=
not
applicable
NA
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
4
of
13
Table
1.
Summary
of
TCMTB
Residues
to
be
Included
in
the
Risk
Assessment
and
Tolerance
Expression.

Matrix
Residues
Included
in
Risk
Assessment
Residues
Included
in
Tolerance
Expression
Ruminant
NA
NA
Livestock
Poultry
NA
NA
Drinking
water
TCMTB
and
2­
MBT
NA
Residue
Data
used
for
Acute
and
Chronic
Dietary
Assessments
Tolerance
level
residues
of
0.10
ppm
were
incorporated
into
the
acute
and
chronic
assessments
for
all
commodities.

Processing
Factors
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
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/.

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
(
DEEMFCID
 
,
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
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
5
of
13
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
foodform
(
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
Toxicological
Dose
and
Endpoints
for
TCMTB.
1,2
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOEs/
UFs
FQPA
safety
factor
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
general
population
including
infants
and
children)
NOAEL=
25.1
mg/
kg/
day
(
21
mg
ai/
kg/
day)

83.55%
ai
purity
UF
=
100
(
10x
interand
intra­
species
extrapolation)

FQPA
SF
=
1x
Acute
PAD
=
0.25
mg
TCMTB/
kg/
day
Developmental
toxicity
study
in
rats
(
MRID
00154295,
92179009
(
1985))

Maternal
LOAEL
=
76.5
mg
TCMTB/
kg/
day
(
64
mg
ai/
kg/
day),
based
on
clinical
signs
of
toxicity
(
ventral
alopecia,
rough
coat,
dyspnea/
wheezing,
oral
discharge,
diarrhea/
loose
stool,
urine
staining,
piloerection,
and
hunched
gait).
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
6
of
13
Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
TCMTB.
1,2
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOEs/
UFs
FQPA
safety
factor
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
females
13­
49)
An
endpoint
for
females
13­
49
was
not
identified
in
the
available
database
for
TCMTB.

Chronic
Dietary
(
all
populations)
LOAEL
=
3.8
mg/
kg/
day
81.6%
ai
purity
UF
=
300
(
10x
inter­
and
intraspecies
extrapolation,
3x
for
use
of
a
LOAEL)

FQPA
SF
=
1x
Chronic
PAD
=
0.01
mg
ai/
kg/
day
Chronic
toxicity
study
in
dogs
(
MRID
41342201,
92179008
(
1989))

LOAEL
=
3.8
mg/
kg/
day
(
males),
based
on
decreased
body
weight
gain,
decreased
white
cells,
monocytes,
and
plasma
ALT;
decreased
uterine
weight
in
females.

Carcinogenicity
The
CPRC
concluded
that
TCMTB
should
be
classified
as
Group
C
­
possible
human
carcinogen
­
and
recommended
that
for
the
purpose
of
risk
characterization,
the
Reference
Dose
(
RfD)
approach
should
be
used
for
quantitation
of
human
risk.
This
was
based
on
statistically
significant
increases
in
tumors
in
both
sexes
of
the
Sprague­
Dawley
rat:
testicular
interstitial
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
This
assessment
concludes
that
for
all
supported
commodities,
the
acute
dietary
risk
estimates
do
not
exceed
HED's
level
of
concern
(
less
than
100%
of
the
aPAD)
at
the
95th
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
95th,
99th,
and
99.9th
percentiles
of
exposure
are
reported
in
Table
3.
The
results
of
the
acute
dietary
exposure
analysis
at
the
95th
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
7
of
13
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
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg.
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.25
0.002430
0.97
0.003992
1.6
0.006732
2.7
All
Infants
(<
1
year
old)
0.25
0.003256
1.3
0.005395
2.2
0.017325
6.9
Children
1­
2
years
old
0.25
0.004467
1.8
0.006779
2.7
0.010134
4.1
Children
3­
5
years
old
0.25
0.004581
1.8
0.006450
2.6
0.010247
4.1
Children
6­
12
years
old
0.25
0.003370
1.4
0.005086
2.0
0.007745
3.1
Youth
13­
19
years
old
0.25
0.002109
0.84
0.003324
1.3
0.004994
2.0
Adults
20­
49
years
old
0.25
0.001547
0.62
0.002258
0.90
0.003428
1.4
Adults
50+
years
old
0.25
0.001192
0.48
0.001810
0.72
0.003464
1.4
Females
13­
49
years
old
0.25
0.001529
0.61
0.002345
0.94
0.003411
1.4
1.
The
bolded
values
represent
the
highest
exposed
populations
for
each
percentile.
2.
NA
=
Not
applicable.

Results
of
Chronic
Dietary
Exposure
Analysis
This
assessment
concludes
that
for
all
supported
commodities,
the
chronic
dietary
risk
estimates
do
not
exceed
HED's
level
of
concern
(
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
Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg.
day)
%
cPAD
General
U.
S.
Population
0.25
0.002430
0.97
0.013
0.000888
6.8
All
Infants
(<
1
year
old)
0.25
0.003256
1.3
0.013
0.000994
7.6
Children
1­
2
years
old
0.25
0.004467
1.8
0.013
0.002054
16
Children
3­
5
years
old
0.25
0.004581
1.8
0.013
0.002226
17
Children
6­
12
years
old
0.25
0.003370
1.4
0.013
0.001625
13
Youth
13­
19
years
old
0.25
0.002109
0.84
0.013
0.000936
7.2
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
8
of
13
Table
4.
Results
of
Acute
and
Chronic
(
Food
and
Water)
Dietary
Exposure
Analyses
for
TCMTB
Using
DEEM­
FCID.
1,2
Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg.
day)
%
cPAD
Adults
20­
49
years
old
0.25
0.001547
0.62
0.013
0.000680
5.2
Adults
50+
years
old
0.25
0.001192
0.48
0.013
0.000542
4.2
Females
13­
49
years
old
0.25
0.001529
0.61
0.013
0.000671
5.2
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.
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
9
of
13
Attachment
1.
Data
and
Residue
Estimates
Used
in
Dietary
Analyses.
Anticipated
Residue
Estimates/
Tolerance
RAC1
Classification2
Data
Source
%
CT
Avg.
3
%
CT
Max.
3
Processing
Factors
Acute
(
Tol,
AR,
RDF)
Chronic
(
Tol,
AR)
Barley,
grain
B
Tolerance
100
100
Bran
7.7x
Pearled
1.2x
Tol
(
0.10
ppm)
Tol
(
0.1
ppm)

Beet,
sugar,
root
B
Tolerance
100
100
Sugar
12.5x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)
Corn,
field,
grain
B
Tolerance
100
100
Oil
25x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)
Cotton,
undelinted
seed
B
Tolerance
100
100
Oil
6.3x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)
Oat,
grain
B
Tolerance
100
100
Rolled
1.4x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)
Rice,
grain
B
Tolerance
100
100
Bran
7.7x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)
Safflower,
seed
B
Tolerance
100
100
Oil
3.3x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)
Water
NA
EDWCs4
NA
NA
NA
AR
(
0.94
ppb)
AR
(
0.67
ppb)
Wheat,
grain
B
Tolerance
100
100
Bran
7.7x
Flour
1.4x
Tol
(
0.10
ppm)
Tol
(
0.10
ppm)

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.
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
10
of
13
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
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
11
of
13
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
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
12
of
13
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
TCMTB
Dietary
Exposure
Assessment
 
RED
DP
Barcode:
D324018
Page
13
of
13
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%