UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
July
10,
2006
SUBJECT:
Triadimefon
/
Triadimenol:
Summary
of
Refinements
and
Revisions
to
the
Human
Health
Risk
Assessment
PC
Code:
109901
/
127201
Case
No:
2700
DP
Barcode:
330611
FROM:
Richard
Griffin,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(
HED)

THROUGH:
William
Hazel,
Chief
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(
7509P)

TO:
John
Pates,
Jr.,
Chemical
Review
Manager
Reregistration
Branch
I
Special
Review
and
Reregistration
Division
(
7508P)

An
assessment
of
the
human
health
effects
of
triadimefon,
a
fungicide
used
primarily
on
turf,
was
first
completed
by
the
Health
Effects
Division
(
HED)
on
November
23,
2005.
This
risk
assessment
was
slightly
revised,
and
reissued
on
February
9,
2006.
The
2/
9/
06
assessment
(
R.
Griffin,
D326678)
indicated
risk
above
target
levels
for:
1)
acute
dietary
exposure
from
food
(
only)
uses;
2)
acute
dietary
exposure
from
drinking
water
(
only);
3)
exposure
due
to
use
on
residential
turf;
and
4)
worker
exposure
associated
with
some
high­
exposure
scenarios.

An
assessment
of
the
human
health
effects
of
triadimenol,
a
triadimefon
metabolite
with
tolerances
for
the
seed
treatment
of
domestic
cotton
and
small
grain,
and
for
imported
bananas,
was
also
first
completed
by
the
Health
Effects
Division
on
November
23,
2005.
This
risk
assessment
did
not
address
worker
exposure
to
triadimenol,
but
did
address
exposure
due
to
the
food
uses
and
due
to
drinking
water
contamination.
The
assessment
indicated
risk
below
target
levels
for
triadimenol
(
only)
due
apparently
to
the
relatively
low
usage
rates
associated
with
seed
treatment.
However,
triadimenol,
as
a
metabolite
of
triadimefon,
and
dependent
on
the
2
triadimefon
toxicity
database
for
risk
assessment,
cannot
be
considered
independently
of
triadimefon.
Accordingly,
acute
and
short­
term
aggregate
assessments
have
been
conducted
which
consider
all
uses
of
triadimenol
and,
because
some
use
scenarios
exceeded
the
Agency's
level
of
concern,
some
of
the
triadimefon
uses.
A
chronic
aggregate
assessment
of
all
uses
of
triadimenol
and
triadimefon
was
also
conducted.

The
primary
registrant
for
triadimefon,
Bayer
CropScience,
responded
to
the
preliminary
risk
assessments
with
error­
only
comments,
and
responded
(
4/
13/
06
and
4/
17/
06)
to
the
revised
risk
assessments
of
2/
9/
06
with
additional
comments
and
with
the
submission
of
new
data.
The
Agency
has
reviewed
and
responded
to
Bayer's
comments
in
memos
dated
6/
20/
06
(
D328262
and
D328604).
Based,
in
part,
on
the
new
data
provided
by
Bayer,
HED
has
made
significant
revisions
to
the
triadimefon
risk
estimates
which
are
summarized
in
the
following
memo.
HED's
2/
9/
06
risk
assessment
for
triadimenol
(
C.
Jarvis
and
R.
Griffin,
D326716)
did
not
indicate
significant
risk
issues
if
triadimenol
is
considered
independently
of
triadimefon,
even
though
the
dietary
assessment
was
not
refined
(
tolerance
level
residue
estimates
were
used).

Toxicology
Risk
estimates
for
triadimefon
are
largely
based
on
the
NOAEL
(
3.4
mg/
kg/
day)
seen
in
a
subchronic
neurotoxicity
study
in
rats.
This
endpoint
(
hyperactivity)
and
dose
supports
risk
estimates
for
acute
dietary,
chronic
dietary,
incidental
oral,
and
inhalation
exposures.
The
total
Uncertainty
Factor
(
UF)
is
1,000
based
on
the
standard
100
(
interspecies
extrapolation
/
intraspecies
variability)
and
an
additional
factor
of
10
to
account
for
the
lack
of
a
developmental
neurotoxicity
(
DNT)
study.
Dermal
exposure
is
assessed
based
on
a
dermal
toxicity
study
in
rabbits
with
a
NOAEL
of
300
mg/
kg/
day
(
with
an
endpoint
of
reactivity/
activity).
The
primary
registrant,
Bayer,
agreed
with
the
Agency
on
the
choice
of
studies
and
dose
levels
for
risk
assessment
and
did
not
comment
on
the
total
uncertainty
factor
of
1,000.
Due
to
a
fairly
wide
dose
spacing,
the
Agency
considered
the
utility
of
a
Benchmark
Dose
(
BMD)
approach
to
refine
the
point
of
departure
(
POD).
The
registrant
has
also
asked
the
Agency
to
consider
the
possibility
of
refining
the
hazard
using
a
BMD
approach.
It
was
determined
that
the
timedependent
data
from
the
neurotoxicity
study
was
not
amenable
to
the
application
of
the
BMD
model
as
it
is
now
available
to
the
Agency
(
although
model
revisions
are
now
being
investigated
to
address
such
data).

In
summary,
the
toxicological
basis
for
the
triadimefon
risk
assessment
has
not
been
changed
since
the
revised
assessment
of
2/
9/
06.

Scope
of
Revisions
Except
for
some
worker
risk
estimates,
most
triadimefon
risk
estimates
have
been
revised
since
the
2/
9/
06
risk
assessment.
Revisions
are
based
on
the
results
of
a
newly
reviewed
residential
exposure
study,
the
assessment
of
lower
use
rates
on
turf,
the
inclusion
of
additional
PDP
and
FDA
residue
monitoring
data
for
food
commodities,
and
the
re­
examination
of
food
processing
data.
Risk
estimates
for
triadimefon
(
or
metabolites)
in
drinking
water
have
also
been
reassessed
based
on
turf
use
scenarios
that
assume
less
than
full
usage
on
golf
courses
(
tees/
greens/
fairways
assessed
independently
or
in
combinations).
The
registrant
also
forwarded
a
detailed
analysis
of
3
the
use
of
triadimefon
to
treat
pine
seeds
prior
to
planting.
Note
that
all
"
percent
crop
treated"
estimates
used
in
the
2/
9/
06
assessment
were
concurred
upon
by
Bayer,
and
have
not
been
revised.

Dietary
Exposure
Triadimefon
Dietary
risk
assessment
is
based
on
the
use
of
triadimefon
on
apples,
grapes,
pears,
pineapple,
and
raspberries.
The
residues
of
concern
for
triadimefon
are
parent
compound
and
metabolites:
triadimenol,
KWG
1323,
and
KWG
1342.
The
primary
metabolite
is
triadimenol,
and
all
metabolites
are
considered
equal
toxicologically
(
and
share
the
same
endpoints/
doses
for
risk
assessment).
Below
is
a
summary
of
the
residue
and
processing
data
that
the
Agency's
current
triadimefon
risk
assessment
is
based
on
the
S.
Ary
(
11/
18/
05,
D314928)
and
Y.
Barnes
&
S.
Piper
(
7/
6/
06,
D314778)
memos.

Triadimenol
Risk
assessment
for
triadimenol
is
based
on
its
use
as
a
seed
treatment
on
barley,
corn,
cotton,
oats,
rye,
sorghum,
wheat,
and
imported
bananas.
Unlike
triadimefon,
there
are
no
uses
on
turf
or
ornamentals,
and
no
residential
exposure
is
expected.
Both
metabolites
(
KWG
1323
and
KWG
1342)
are
considered
equal
toxicologically
(
and
share
the
same
endpoints/
doses
for
risk
assessment).
However,
as
stated
above,
triadimenol
as
an
independent
pesticide
has
not
been
reassessed,
and
the
following
data
pertains
to
triadimefon
(
only).
The
Agency's
current
triadimenon
risk
assessment
is
based
on
the
S.
Ary
(
11/
18/
05,
D314928)
and
Y.
Barnes
&
S.
Piper
(
7/
6/
06,
D314778)
memos.

Dietary
Data
Sources
The
HED
Metabolism
Assessment
Review
Committee
(
MARC)
concluded
that
triadimefon,
triadimenol,
KWG
1323,
and
KWG
1342
are
the
residues
of
concern
when
assessing
risk
for
triadimefon,
and
that
triadimenol,
KWG
1323
and
KWG
1342
are
the
residues
of
concern
when
assessing
risk
for
triadimenol
(
only).
The
HED
residue
estimates
for
risk
assessment
are
based
primarily
on
USDA/
PDP
and
FDA
monitoring
data.
However,
because
PDP
and
FDA
did
not
analyze
for
KWG
1323
and
KWG
1342
in
apples,
grapes,
pears,
pineapple,
and
raspberries,
a
method
was
needed
to
account
for
the
KWG
metabolites.
Based
on
the
similarities
of
grapes
to
the
other
supported
crops,
the
data
found
in
the
grape
metabolism
study
was
used
to
derive
a
ratio
(
1.25)
that
would
estimate
TTR,
or
all
metabolites,
based
on
the
measured
total
triadimefon
and
triadimenol
residue.
For
this
assessment,
HED
summed
estimates
for
triadimefon
and
triadimenol
and
multiplied
the
total
by
1.25
to
account
for
the
metabolites
KWG
1323
and
KWG
1342.

Apple
PDP
data
from
2003
were
used
for
apples.
A
total
of
744
samples
were
analyzed
for
both
triadimefon
and
triadimenol.
Triadimefon
was
not
detected
in
any
samples
and
triadimenol
was
detected
in
14
samples.
The
estimated
maximum
%
crop
treated
(
CT)
for
apples
of
10%
was
used
for
the
acute
dietary
risk
assessment
and
the
estimated
average
%
CT
(
5%)
was
used
for
the
chronic
dietary
risk
assessment.
The
ratio
of
TTR
to
triadimefon/
triadimenol
of
1.25
from
the
grape
metabolism
study
was
used
to
estimate
the
total
residues
of
concern.
4
Grape
PDP
data
from
2004
were
used
for
grapes.
A
total
of
738
samples
were
analyzed
for
triadimefon
and,
of
this
total,
212
samples
were
analyzed
for
triadimenol.
Triadimefon
was
not
detected
in
any
samples
and
triadimenol
was
detected
in
15
samples.
The
estimated
maximum
%
CT
for
grapes
of
5%
was
used
for
the
acute
dietary
risk
assessment
and
the
estimated
average
%
CT
of
1%
was
used
for
the
chronic
dietary
risk
assessments.
The
ratio
(
1.25)
of
TTR
to
triadimefon/
triadimenol
from
the
grape
metabolism
study
was
used
to
estimate
the
total
residues
of
concern
based
on
reported
triadimefon
and
triadimenol
residues
in
monitoring
samples.

Pear
PDP
data
from
2003
and
2004
were
used
for
pears.
A
total
of
928
samples
were
analyzed
for
triadimefon
and
270
of
these
928
samples
were
analyzed
for
triadimenol.
Triadimefon
and
triadimenol
were
not
detected
in
any
samples.
The
estimated
maximum
%
CT
for
pears
of
5%
was
used
for
the
acute
dietary
risk
assessment
and
the
estimated
average
%
CT
of
5%
was
used
for
the
chronic
dietary
risk
assessments.
The
ratio
(
1.25)
of
TTR
to
triadimefon/
triadimenol
from
the
grape
metabolism
study
was
used
to
estimate
the
total
residues
of
concern
based
on
reported
triadimefon
and
triadimenol
residues
in
monitoring
samples.

Pineapple
PDP
data
from
2002
was
used
for
pineapples.
A
total
of
360
samples
were
analyzed
for
triadimefon
and
52
of
these
360
samples
were
analyzed
for
triadimenol.
Triadimefon
was
detected
in
16
samples
and
triadimenol
was
detected
in
1
sample.
The
estimated
%
CT
for
pineapples
of
100%
was
used
for
the
acute
and
chronic
dietary
risk
assessments.
The
ratio
(
1.25)
of
TTR
to
triadimefon/
triadimenol
from
the
grape
metabolism
study
was
used
to
estimate
the
total
residues
of
concern
based
on
reported
triadimefon
and
triadimenol
residues
in
monitoring
samples.

Raspberry
FDA
data
(
1996­
2003)
was
used
for
raspberries.
A
total
of
320
samples
were
analyzed
for
both
triadimefon
and
triadimenol.
A
total
of
20
samples
contained
triadimefon
and/
or
triadimenol
residues.
The
estimated
maximum
%
CT
for
raspberries
of
50%
was
used
for
the
acute
dietary
risk
assessment
and
the
estimated
average
%
CT
of
50%
was
used
for
the
chronic
dietary
risk
assessments.
The
ratio
(
1.25)
of
TTR
to
triadimefon/
triadimenol
from
the
grape
metabolism
study
was
used
to
estimate
the
total
residues
of
concern
based
on
reported
triadimefon
and
triadimenol
residues
in
monitoring
samples.

Processing
Factors
Data
from
the
processing
studies
were
used
in
this
assessment
for
several
commodities
along
with
(
default)
processing
factors
for
dried
apple
(
8.0x),
dried
pear
(
6.25x),
and
dried
pineapple
(
5.0x).
0.6x
was
utilized
for
apple
juice
and
4.0x
for
raisin.
All
other
processed
commodities
showed
little
or
no
concentration
in
the
available
processing
studies.

A
summary
and
comparison
of
the
data
used
by
both
Bayer
and
the
Agency
can
be
found
in
the
appendix.

Risk
Estimates
The
following
table
summarizes
the
reassessment
for
acute
dietary
exposure
to
triadimefon
(
and
metabolites),
based
on
the
data
outlined
above
(
from
Y.
Barnes
and
S.
Piper,
7/
6/
06,
D314778):
5
Acute
Dietary
Exposure
Analysis
for
Food
Alone
Reflecting
All
Uses
of
Triadimefon
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
0.0034
0.000014
<
1
0.000097
3
0.000506
15
All
Infants
(<
1
year
old)
0.0034
0.000051
1.5
0.000231
7
0.000717
21
Children
1­
2
years
old
0.0034
0.000109
3
0.000446
13
0.001679
49
Children
3­
5
years
old
0.0034
0.000069
2
0.000268
8
0.001096
32
Children
6­
12
years
old
0.0034
0.000031
<
1
0.000139
4
0.000516
15
Youth
13­
19
years
old
0.0034
0.000005
<
1
0.000060
2
0.000240
7
Adults
20­
49
years
old
0.0034
0.000007
<
1
0.000060
2
0.000351
10
Adults
50+
years
old
0.0034
0.000010
<
1
0.000058
2
0.000275
8
Females
13­
49
year
old
0.0034
0.000007
<
1
0.000068
2
0.000353
10
If
drinking
water
exposure
(
assuming
treatment
of
only
golf
course
tees
and
greens
as
a
potential
mitigation
measure)
is
added
to
the
above
triadimefon
food­
only
exposure,
the
estimate
of
acute
risk
rises
to
32%
of
the
aPAD
for
the
general
population
and
73%
of
the
aPAD
for
all
infants
(<
1
year).
6
The
corresponding
reassessment
of
chronic
risk
(
assuming
use
on
the
entire
golf
course)
is
summarized
in
the
following
table:

Chronic
Dietary
Exposure
Analysis
for
Food
Alone
and
Food
+
Drinking
Water
(
Entire
Course)

Food
Alone
Food
+
Drinking
Water
(
Entire
Course)

Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.0034
0.000017
<
1
0.000480
14
All
Infants
(<
1
year
old)
0.0034
0.000026
<
1
0.001546
46
Children
1­
2
years
old
0.0034
0.000091
3
0.000780
23
Children
3­
5
years
old
0.0034
0.000056
2
0.000701
21
Children
6­
12
years
old
0.0034
0.000021
<
1
0.000466
14
Youth
13­
19
years
old
0.0034
0.000008
<
1
0.000343
10
Adults
20­
49
years
old
0.0034
0.000010
<
1
0.000443
13
Adults
50+
years
old
0.0034
0.000012
<
1
0.000468
14
Females
13­
49
year
old
0.0034
0.000011
<
1
0.000442
13
If
drinking
water
is
removed
from
the
chronic
assessment,
the
risk
estimates
attributable
to
food
only
decline
to
approximately
1%
of
the
cPAD
for
the
general
population
and
3%
of
the
cPAD
for
children
(
1­
3
yrs
old).

For
additional
detail
concerning
dietary
risk
estimates,
please
refer
to
the
7/
6/
06
Y.
Barnes
and
S.
Piper
memo
Triadimefon:
Revised
Acute,
Probabilistic
and
Chronic
Dietary
(
Food
+
Drinking
Water)
Exposure
and
Risk
Assessments
for
Triadimefon
Reregistration.

Aggregate
Exposure
/
Risk
The
2/
9/
06
risk
assessment
for
triadimefon
did
not
present
estimates
for
aggregate
exposure,
since
each
exposure
parameter
of
triadimefon
(
food/
drinking
water/
residential)
exceeded
its
own
target
level
Margin
of
Exposure
(
MOE)
of
1,000.

Triadimenol
exposure
from
its
independent
use
as
an
active
ingredient,
however,
did
not
exceed
either
the
aPAD
(
29%
for
children
1­
2)
at
the
95th
percentile
of
exposure
or
the
cPAD
(
23%
for
children
1­
2)
based
on
food
and
drinking
water
combined.
Food
residues
comprised
the
major
portion
of
the
dietary
exposure.
Note
that
this
was
an
upper­
end
assessment
in
which
banana
field
trial
data,
tolerance
levels
for
all
other
foods,
and
100%
crop
treated
were
assumed.

Since
the
data
listed
above
(
7/
6/
06
Barnes
and
Piper
memo)
for
triadimefon
has
been
used
to
7
refine
the
dietary
risk
assessment
(
food
only)
to
a
level
below
the
aPAD
(
and
below
the
cPAD),
HED
has
proceeded
to
the
next
step
in
the
risk
assessment
process,
and
has
aggregated
the
foodonly
exposure
estimates
of
both
chemicals
(
based
on
the
conclusion
that
triadimefon,
triadimenol,
KWG
1323,
and
KWG
1342
are
toxicologically
equivalent).
Aggregation
of
shortterm
golfer
exposure
with
background
(
chronic)
food
and
drinking
water
exposure
has
also
been
performed.
It
should
be
noted
though,
that,
because
risk
exceeds
the
Agency's
LOC
for
the
possible
oral
exposure
of
small
children
on
lawns
(
or
turf),
a
decision
has
been
made
by
the
Agency
to
not
aggregate
residential
exposure
to
triadimefon.

Acute
Aggregate
As
a
first
step,
the
residue
data
sets
for
triadimefon
and
triadimenol
food
uses
were
combined
and
a
probabilistic­
based
acute
assessment
was
completed
for
food
only.
The
highest
risk
estimate,
based
on
the
above
residue
and
usage
data
for
triadimefon,
and
an
unrevised
dataset
for
triadimenol,
is
73%
of
the
aPAD
for
all
infants
(<
1
year,
and
representing
the
upper­
end)
and
38%
of
the
aPAD
for
the
general
U.
S.
population
at
the
99.9th
percentile
of
exposure.
Drinking
water
is
not
part
of
this
estimate.
A
sensitivity
analysis
was
conducted
to
assess
the
effect
of
using
½
the
Level
of
Detection
(
LOD)
for
triadimefon
"
non­
detect"
samples,
or
assuming
no
residue
(
or
zero
residue)
for
the
commodities
(
other
than
raspberries
and
pineapple),
which
had
detectable
triadimefon
residues.
The
effect
of
using
zeros
was
minimal
in
this
instance;
with
a
risk
estimate
of
69%
of
the
aPAD
for
children
1­
2
years
old,
and
37%
of
the
aPAD
for
the
general
U.
S.
population.
Note
that
a
probabilistic­
type
assessment
was
conducted
for
this
acrosschemical
aggregate
but
that
upper­
end
point
estimates
for
all
but
banana,
and
100%
crop
treated
for
all
crops
were
assumed
for
triadimenol.
The
risk
estimates
just
noted
were
determined
at
the
99.9th
percentile
of
exposure.

Second,
the
residue
data
sets
for
triadimefon
and
triadimenol
food
uses
were
combined
with
a
drinking
water
estimate,
based
on
a
potential
mitigation
option
to
restrict
use
of
triadimefon
to
tees
and
greens
(
only).
The
highest
risk
estimate,
based
on
the
refined
residue
and
usage
data
for
triadimefon,
unrefined
data
for
triadimenol,
and
drinking
water
reflecting
use
on
tees
and
greens,
is
82%
of
the
aPAD
for
the
population
subgroup
"
all
infants"
(
representing
the
upper­
end)
and
51%
of
the
aPAD
for
the
general
U.
S.
population.
These
risk
figures
represent
the
aggregation
of
food
and
drinking
water
sources
of
triadimefon
and
triadimenol
assuming
the
golf
course
use
of
triadimefon
is
restricted
to
tees
and
greens
only.

If
an
assumption
is
made
that
triadimefon
is
used
on
the
entire
golf
course,
or
if
use
would
be
restricted
to
fairways
(
only)
or
fairways,
tees
and
greens
(
only),
the
risk
estimate
rises
to
>
415%
of
the
aPAD
for
the
population
subgroup
"
all
infants"
(
which
represents
the
upper­
end
of
exposure).

Short­
term
Aggregate
As
discussed
previously,
the
residential
uses
of
triadimefon
on
turf
and
ornamentals
results
in
risk
estimates
for
children
that
exceed
the
Agency's
LOC
and,
as
a
result,
have
not
been
aggregated.
The
only
other
"
residential"
or
"
non­
occupational"
exposure
that
could
occur
to
golfers
is
from
use
of
triadimefon
on
golf
courses.
This
is
considered
to
be
a
short­
term
8
exposure
scenario.
HED
assessed
short­
term
aggregate
risk
for
adult
and
youth
golfers
by
calculating
an
Aggregate
Risk
Index
(
ARI)
that
assumes
a
background
(
chronic)
exposure
to
triadimefon
and
triadimenol
residues
from
dietary
(
food
and
water)
sources.
(
Note
that
the
chronic
exposure
from
drinking
water
considers
treatment
of
an
entire
golf
course
as
opposed
to
to
only
tees
and
greens
since
the
Agency's
level
of
concern
is
not
exceeded.)
Dietary
(
food
and
water)
risk
numbers,
expressed
as
MOEs,
are
15,000
for
both
adults
and
youth.
MOEs
from
exposure
to
golfers
are
7,800
for
youths
and
12,000
for
adults.
The
short­
term
aggregate
risk,
calculated
as
ARIs
are
4,300
for
youths
and
6,700
for
adults.
Neither
of
these
estimates
exceed
the
Agency's
level
of
concern
(
MOE
1,000.)

Chronic
Aggregate
Estimates
of
chronic
aggregate
exposure
to
both
triadimefon
and
triadimenol
(
as
separate
pesticides)
are
based
on
the
combined
estimates
of
chronic
exposure
due
to
both
food
sources
and
to
drinking
water
sources.
It
should
be
noted
that
the
exposure
estimates
for
triadimefon
have
been
refined
with
the
use
of
residue
and
percent
use
data,
but
the
exposure
estimates
of
triadimenol
are
considered
upper­
bound
estimates
based
on
tolerance
level
residue
and
100%
treatment
of
each
commodity.
In
regard
to
drinking
water,
the
exposure
estimates
below
are
based
on
full
use
of
triadimefon
on
golf
courses
to
represent
the
worst
case
scenario..
In
short,
of
the
four
parameters
contributing
to
chronic
exposure
to
both
pesticides;
triadimefon
food/
water
and
triadimenol
food/
water,
the
only
refinement
away
from
the
upper­
bound
has
been
done
for
triadimefon
food
uses.

Based
on
the
above,
the
total
chronic
exposure
to
both
pesticides
is
estimated
to
be
21%
of
the
cPAD
for
the
general
population
and
59%
of
the
cPAD
for
"
all
infants."
Chronic
aggregate
risk
does
not
appear
to
be
a
significant
risk
for
triadimefon
and
triadimenol.

Occupational
Since
the
2/
9/
06
assessment,
the
portion
of
the
triadimefon
risk
assessment
concerning
risk
to
workers
has
been
revised
to
reflect
the
usage
rates
supported
by
Bayer.

In
most
exposure
scenarios,
dermal
and
inhalation
MOEs
met
or
exceeded
100
at
some
level
of
risk
mitigation.
In
the
majority
of
scenarios
where
data
are
available,
inhalation
risk
was
not
a
concern
at
"
baseline"
(
no
respirator)
and
dermal
risk
was
not
a
concern
at
baseline
(
or
baseline
plus
chemical­
resistant
gloves).
However,
there
were
inhalation
concerns
for
several
of
the
scenarios
involving
mixing/
loading
wettable
powder
to
support
application
to
turf
unless
engineering
controls
(
water­
soluble
packaging)
are
used.
The
inhalation
risk
in
two
scenarios
remain
a
concern
with
maximum
inhalation
risk
mitigation:
1)
mixing/
loading/
applying
wettable
powders
with
a
low
pressure
handwand
to
turf
(
LCO
and
golf
course)
at
the
5.4
lb
ai/
A
application
rate,
where
the
MOE
=
46
with
double
layer
and
gloves
and
a
90%
protection
factor
for
a
half­
face
respirator;
and
2)
mixing/
loading/
applying
wettable
powders
with
a
low
pressure
handwand
to
turf
(
LCO
and
golf
course)
at
the
2.7
lb
ai/
A
application
rate,
where
the
MOE
=
92
with
a
double
layer
and
gloves
and
a
90%
protection
factor
for
a
half­
face
respirator.

There
are
no
data
to
assess
mixing/
loading/
applying
liquids
with
a
tree
injector
or
9
mixing/
loading/
applying
ready­
to­
use
briquettes.
HED
recommends
that
handlers
in
these
scenarios
wear
baseline
attire
plus
chemical­
resistant
gloves.
There
also
are
no
data
to
assess
mixing/
loading/
applying
dips.
HED
recommends
that
handlers
involved
in
dip
applications
wear
baseline
attire
plus
chemical­
resistant
gloves
and
chemical­
resistant
apron.
HED
has
no
data
to
assess
risks
to
handlers
participating
in
drying,
raking,
and
bagging
treated
seed;
however,
HED
expects
that
exposures
could
be
significant.
Therefore,
HED
recommends
that
these
handlers
wear
baseline
attire
plus
chemical­
resistant
gloves
and
a
chemical­
resistant
apron.
Provided
the
above
personal
protective
clothing
requirements
are
required,
HED
believes
that
risk
for
workers
performing
these
applications
will
not
exceed
the
Agency's
level
of
concern.
10
Appendix
Summary
Table
Comparison
of
Data
Sources
used
by
Bayer
and
HED
RAC
Data
Source
Years
No.
of
Samples
No.
of
Detectable
Residues
Processing
Factors
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
&
Cancer
(
Tol.,
AR)
Apple
(
Bayer)
1)
PDP
(
1.25x
factor)
2)
PDP(
1.25
factor)
for
KWG
1323&
1342
2003
744
14
Juice
at
0.6x
TOTALZ=
730
TOTALNZ=
14
AR
(
0.0002)

Apple
(
HED)
PDP
(
1.25x
factor)
2003
744
14
Juice
at
0.6x
TOTALZ=
670
TOTALLOD=
60
LODRES=
0.0.00125
AR
(
0.00014)

1)
Bayer
and
HED
used
the
same
data
source,
and
apple
juice
processing
factor.
2)
Bayer
used
an
additional
(
1.25
factor)
for
KWG
1323
&
1342.
3)
Bayer
used
a
different
AR
estimate.

RAC
Data
Source
Years
No.
of
Samples
No.
of
Detectable
Residues
Processing
Factors
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
&
Cancer
(
Tol.,
AR)
Grape
(
Bayer)
1)
PDP
(
1.25x
factor)
2)
PDP(
1.25
factor)
for
KWG
1323&
1342
2004
212
15
Raisin
at
2.6
Juice
at
0.25
TOTALZ=
197
TOTALNZ=
15
AR
(
0.0052)

Grape
(
HED)
PDP
(
1.25X
FACTOR)
2004
738
15
Raisin
at
4x
TOTALZ=
701
TOTALLOD=
22
LODRES=
0.025
AR
(
0.027)

1)
Bayer
and
HED
used
the
same
data
source.
2)
Bayer
used
different
processing
factors
for
raisins,
total
number
of
samples
and
AR
estimate.
3)
Bayer
used
an
additional
(
1.25
factor)
for
KWG
1323
&
1342.

RAC
Data
Source
Years
No.
of
Sample
s
No.
of
Detectable
Residues
Processing
Factors
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
&
Cancer
(
Tol.,
AR)
Pear
(
Bayer)
Apple
PDP
data
1)
PDP
(
1.25x
factor)
2)
PDP(
1.25
factor)
for
KWG
1323&
1342
2003­
04
744
14
Dried
at
6.25x
TOTALZ=
256
TOTALNZ=
0
AR
(
0.0013)

Pear
(
HED)
Pear
PDP
data
2003­
04
928
0
Dried
at
6.25x
TOTALZ=
882
TOTALLOD=
46
LODRES=
0.025
AR
(
0.001)

1)
Bayer
and
HED
used
the
same
data
source
and
dried
pear
processing
factor.
2)
Bayer
used
different
total
number
of
samples
and
AR
estimates.
3)
Bayer
used
an
additional
(
1.25
factor)
for
KWG
1323
&
1342.
11
Summary
Table
(
Continued)
Comparison
of
Data
Sources
used
by
Bayer
and
HED
RAC
Data
Source
Years
No.
of
Sample
s
No.
of
Detectable
Residues
Processing
Factors
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
&
Cancer
(
Tol.,
AR)

Pineapple
(
Bayer)
Field
trial
data
N/
A
10
10
Dried
at
5.0
Juice
at
0.25
Pulp
at
0.01
TOTALZ=
0
TOTALNZ=
10
LODRES=
0.005
AR
(
0.079)

Pineapple
(
HED)
PDP
2002
360
17
Dried
at
5.0
Juice
at
1
Pulp
at
1
TOTALZ=
0
TOTALLOD=
343
LODRES=
0.025
AR
(
0.001)

1)
Bayer
used
a
field
trial
data
source.
2)
HED
used
the
latest
PDP
data
source.
3)
Bayer
used
different
processing
factors.

RAC
Data
Source
Years
No.
of
Sample
s
No.
of
Detectable
Residues
Processing
Factors3
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
&
Cancer
(
Tol.,
AR)

Raspberry
(
Bayer)
FDA
1)
PDP
(
1.25x
factor)
2)
PDP(
1.25
factor)
for
KWG
1323&
1342
1996­
2003
320
20
None
TOTALZ=
160
TOTALNZ=
20
AR
(
0.024)

Raspberry
(
HED)
FDA
1996­
2003
320
20
None
TOTALZ=
160
TOTALLOD=
140
LODRES=
0.005
AR
(
0.024)

1)
Bayer
and
HED
used
the
same
FDA
data
source.
2)
Bayer
used
an
additional
(
1.25
factor)
for
KWG
1323
&
1342.

RAC
Data
Source
Years
No.
of
Sample
s
No.
of
Detectable
Residues
Processing
Factors
Anticipated
Residue
Estimates/
Tolerance
Acute
(
Tol.,
AR,
RDF)
Chronic
&
Cancer
(
Tol.,
AR)
Apple
(
blended;
HED)
PDP
(
1.25x
factor)
2003
744
14
Dried
8.0
TOTALZ=
0
TOTALLOD=
730
LODRES=
0.00125
AR(
0.0013)

1)
Bayer
did
not
use
this
data
source.
