Document ID: EPA-HQ-OPP-2006-0038-0033
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-30T04:00Z

Triadimefon
and
Triadimenol
(
RED/
TRED)
Fact
Sheet
August
2006
Pesticide
Reregistration
All
pesticides
sold
or
distributed
in
the
United
States
must
be
registered
by
EPA,
based
on
scientific
studies
showing
that
they
can
be
used
without
posing
unreasonable
risks
to
people
or
the
environment.
Because
of
advances
in
scientific
knowledge,
the
law
requires
that
pesticides
first
registered
before
November
1,
1984,
be
reregistered
to
ensure
that
they
meet
today's
more
stringent
standards.

In
evaluating
pesticides
for
reregistration,
EPA
obtains
and
reviews
a
complete
set
of
studies
from
pesticide
producers
that
describe
the
human
health
and
environmental
effects
of
each
pesticide.
To
implement
provisions
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
EPA
considers
the
special
sensitivity
of
infants
and
children
to
pesticides,
as
well
as
aggregate
exposure
of
the
public
to
pesticide
residues
from
all
sources,
and
the
cumulative
effects
of
pesticides
and
other
compounds
with
common
mechanisms
of
toxicity.
The
Agency
develops
any
mitigation
measures
or
regulatory
controls
needed
to
effectively
reduce
each
pesticide's
risks.
EPA
then
reregisters
pesticides
that
meet
current
human
health
and
safety
standards
and
can
be
used
without
posing
unreasonable
risks
to
human
health
and
the
environment.

When
a
pesticide
is
eligible
for
reregistration,
EPA
explains
the
basis
for
its
decision
in
a
Reregistration
Eligibility
Decision
(
RED)
document.
For
the
purpose
of
tolerance
reassessment,
EPA
explains
the
basis
for
its
decision
in
a
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
document.
This
fact
sheet
summarizes
the
information
in
the
RED/
TRED
document
for
the
pesticide
triadimefon
and
the
tolerance
reassessment
for
triadimenol,
case
number
2700
(
PC
Codes
109901
and
127201).

Regulatory
History
 
Triadimefon
and
triadimenol
are
broad
spectrum,
systemic
fungicides.
 
Triadimenol
is
the
primary
metabolite
of
triadimefon
and
is
registered
separately
under
its
own
active
ingredient
number.
 
Triadimenol
was
first
registered
after
1984
and
is
not
subject
to
reregistration
under
the
1988
amendments
to
FIFRA.
It
is
being
assessed
by
the
Agency
for
the
purposes
of
a
tolerance
reassessment.
 
Triadimefon
and
triadimenol
belong
to
a
group
of
pesticides
called
triazoles
(
or
conazoles),
which
also
includes
propiconazole,
another
triazole
fungicide
subject
to
reregistration.
However,
for
the
purpose
of
this
reregistration
eligibility
decision
(
RED)
for
triadimefon
and
tolerance
reassessment
for
triadimenol,
EPA
has
concluded
that
triadimefon
and
triadimenol
do
not
share
a
common
mechanism
of
toxicity
with
other
substances.
 
The
registrant
has
agreed
to
delete
all
food
uses
(
except
pineapple)
and
residential
turf
uses.
Therefore,
the
Reregistration
Eligibility
Decision
document
only
evaluates
risks
from
all
currently
supported
uses
of
triadimefon.

Uses
 
Triadimefon
is
used
to
control
various
fungal
diseases
in
fruit
(
pineapple)
and
non­
food
use
sites
such
as:
pine
seedlings,
Christmas
trees,
residential
(
sod
farm)
and
commercial
turf,
ornamentals,
and
landscapes.
 
Triadimenol
is
used
as
a
seed
treatment
on:
barley,
corn,
cotton,
oats,
rye,
sorghum,
and
wheat.
There
is
also
an
import
tolerance
for
bananas.
 
Total
triadimefon
use
averaged
135,000
lbs
ai/
year
with
an
upper­
end
estimate
of
266,000
lbs
ai/
year.
 
Approximately
24,000
lbs
ai
of
triadimenol
are
applied
annually.

Health
Effects
 
The
endpoint
of
concern
for
triadimefon
and
triadimenol
is
neurotoxicity,
which
was
observed
in
rat,
mice,
and
rabbit
studies.
 
Since
no
appropriate
acute
endpoint
could
be
determined
from
the
triadimenol
database,
the
triadimefon
subchronic
neurotoxicity
study
in
rats
was
chosen
for
the
acute
reference
dose
(
aRfD)
for
triadimenol,
as
well.
 
In
addition,
the
subchronic
neurotoxicity
study
for
triadimefon
was
also
chosen
for
the
chronic
reference
dose
(
cRfD)
for
triadimenol.
 
The
Cancer
Assessment
Review
Committee
(
CARC)
assigned
triadimefon
and
triadimenol
a
classification
of
Category
C
"
possible
human
carcinogen".
As
a
result,
a
quantitative
cancer
risk
assessment
was
not
appropriate
and
was
not
conducted.
The
human
health
risk
assessment
was
based
on
the
population
adjusted
dose
(
PAD)
and
margin
of
exposure
(
MOE)
approaches,
only.

Ecological
Effects
 
Triadimefon
is
classified
as
moderately
toxic
to
freshwater
fish
and
invertebrates
on
an
acute
basis.
 
Triadimenol
is
classified
as
slightly
toxic
to
freshwater
fish
and
moderately
toxic
to
freshwater
invertebrates
on
an
acute
basis.
 
No
triadimefon
or
triadimenol
acute
toxicity
tests
were
submitted
for
estuarine/
marine
fish
or
invertebrates.
 
Triadimefon
and
triadimenol
are
classified
as
practically
non­
toxic
to
birds
on
an
acute
basis.
 
Triadimefon
and
triadimenol
are
classified
as
slightly
toxic
to
mammals
on
an
acute
basis.

Risks
 
Combined
acute
dietary
(
food
and
water)
risk
estimates
were
calculated
based
on
combined
dietary
exposure
from
pineapples
(
triadimefon)
and
drinking
water
(
triadimefon
from
golf
course
application
to
entire
golf
course),
seed
treatment
uses
(
triadimefon
and
triadimenol)
and
bananas
(
triadimenol
import
tolerance).
Risks
were
below
the
Agency's
level
of
concern
(<
100%
aPAD)
at
the
95th
percentile
of
exposure
(
assuming
2
applications
per
year
for
turf
at
2.7
lbs
ai/
A).
The
dietary
exposure
for
acute
food
and
drinking
water
was
33%
of
the
aPAD
for
the
U.
S.
population
and
94%
of
the
aPAD
for
all
infants
less
than
one
year
old,
the
most
highly
exposed
population
subgroup.
 
The
chronic
dietary
risk
from
exposure
to
food
and
drinking
water
was
below
the
Agency's
level
of
concern,
at
18%
of
the
cPAD
for
the
U.
S.
population
and
57%
of
the
cPAD
for
non­
nursing
infants,
the
most
highly
exposed
population
subgroup.
 
Inhalation
risks
for
residential
handlers
were
below
the
level
of
concern
for
all
residential
uses
of
triadimefon.
However,
combined
dermal
and
inhalation
risks
were
above
the
level
of
concern
(
MOEs
<
1000)
for
mixing,
loading,
and
applying
triadimefon
with
a
hose­
end
sprayer
to
greenhouse
ornamentals.
 
In
the
majority
of
occupational
scenarios
where
data
are
available,
combined
dermal
and
inhalation
risks
were
below
the
level
of
concern
at
baseline
(
long­
sleeve
shirt,
long
pants,
shoes,
socks,
no
respirator)
or
baseline
plus
chemical­
resistant
gloves.
However,
there
were
risk
concerns
requiring
additional
dermal
or
inhalation
protection
(
e.
g.
a
respirator
or
engineering
controls)
for
several
of
the
scenarios
involving
mixing/
loading/
applying
wettable
powder.
 
Acute
and
chronic
RQs
for
birds
and
mammals
exceeded
the
level
of
concern.
 
Risks
(
RQs)
did
not
exceed
the
level
of
concern
for
freshwater
fish,
freshwater
invertebrates,
and
aquatic
non­
vascular
plants.
 
No
data
were
available
to
assess
the
risks
to
estuarine/
marine
invertebrates,
estuarine/
marine
fish,
vascular
aquatic
plants,
and
terrestrial
plants.
 
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
resulted
in
the
determination
that
triadimefon
will
have
no
direct
acute
effects
on
threatened
and
endangered
freshwater
fish,
freshwater
aquatic
invertebrates,
and
aquatic
non­
vascular
plants.
However,
the
assessment
indicated
that
triadimefon
has
the
potential
for
causing
acute
risk
to
endangered
birds
and
mammals.
Chronic
RQs
for
endangered
mammals
exceeded
the
level
of
concern
at
all
application
rates
modeled.
Chronic
RQs
for
endangered
birds
also
exceeded
the
level
of
concern.
No
data
were
available
to
assess
the
risks
to
estuarine/
marine
invertebrates,
estuarine/
marine
fish,
vascular
aquatic
plants,
and
terrestrial
plants.
Therefore,
risks
cannot
be
precluded
on
these
species
at
this
time.

Risk
Mitigation
The
following
risk
mitigation
measures
are
required
for
triadimefon
and
triadimenol
to
address
risks
of
concern.

Dietary
(
Food
and
Water)
Risk
Mitigation:

 
Bayer,
the
sole
technical
registrant,
has
agreed
to
voluntarily
delete
all
triadimefon
food
uses,
except
for
pre­
plant
and
post­
harvest
use
on
pineapples.
Food
uses
to
be
deleted
include
apples,
pears,
grapes,
and
raspberries
(
in
both
commercial
and
residential
settings).
In
order
to
reduce
potential
drinking
water
exposure
to
triadimefon,
use
on
turf
will
be
restricted
to
golf
courses
and
sod
farms,
only,
with
a
maximum
single
application
rate
of
4
2.7
lbs
ai/
A,
and
a
maximum
yearly
rate
of
5.4
lbs
ai/
A.
With
the
above
use
deletions
and
restrictions,
aggregate
(
food
and
water)
risks
are
below
the
Agency's
level
of
concern.

Residential
Risk
Mitigation
 
The
following
residential
uses
will
remain
as
labeled
use
sites
for
triadimefon:
­
Outdoor
ornamental
flowers,
shrubs,
and
trees;
­
Greenhouse
ornamental
flowers,
shrubs,
and
trees.
 
Bayer,
the
sole
technical
registrant,
has
agreed
to
request
voluntary
deletions
of
the
residential
turf
use
to
address
post­
application
and
aggregate
risks
to
toddlers.
In
addition,
a
17­
day
post­
application,
pre­
harvest
interval
is
required
for
sod
farm
turf,
to
address
potential
risks
to
toddlers
exposed
to
sod
farm
turf
transplanted
to
a
residential
setting.
 
In
order
to
address
risks
to
residential
handlers
making
applications
to
ornamentals,
the
following
mitigation
measures
are
required:
­
Package
all
wettable
powder
products
in
water­
soluble
bags;
­
Prohibit
application
with
hose­
end
sprayers
in
residential
greenhouses;
­
Reduce
the
application
rate
for
all
outdoor
ornamental
applications
to
a
maximum
of
0.0025
lbs
ai/
gallon
(
for
certain
use
sites,
rates
will
remain
lower
than
this
maximum).
 
Currently,
the
number
of
applications
that
can
be
made
to
golf
course
turf
is
not
specified
on
product
labels.
Golf
course
use
will
be
restricted
to
a
maximum
single
application
rate
of
2.7
lbs
ai/
A,
and
a
maximum
yearly
rate
of
5.4
lbs
ai/
A.
Although
aggregate
risks
to
golfers
(
youths
and
adults)
do
not
currently
exceed
the
Agency's
level
of
concern,
this
mitigation
measure
will
further
reduce
exposure
to
golfers.

Occupational
Risk
Mitigation
 
The
following
commercial
and
agricultural
uses
will
remain
as
labeled
use
sites
for
triadimefon:
­
Golf
course
turf
­
Sod
farm
turf
­
Outdoor
ornamental
flowers,
shrubs,
and
trees
­
Greenhouse
ornamental
flowers,
shrubs,
and
trees
­
Roses
­
Azaleas,
for
control
of
pine­
twisting
rust
only
­
Pines,
including
Christmas
trees
­
Pine
seedlings
­
Pine
seed
(
in­
nursery
and
commercial)
­
Pineapples
(
pre­
plant
and
post­
harvest
dip)
 
Bayer,
the
sole
registrant
has
requested
that
use
on
apples,
pears,
grapes,
raspberries,
and
all
turf
other
than
golf
course
and
sod
farm
turf
be
voluntarily
deleted,
reducing
handler
exposure.
For
golf
courses
and
sod
farms,
a
maximum
single
application
rate
of
2.7
lbs
ai/
A,
and
a
maximum
yearly
rate
of
5.4
lbs
ai/
A
are
required,
further
reducing
handler
5
exposure.
Golf
course
applications
will
be
restricted
to
turf
less
than
2.5
inches
in
height,
which
will
limit
application
to
golf
course
roughs.
 
In
order
to
address
risks
to
occupational
handlers
mixing,
loading,
and
applying
triadimefon,
the
mitigation
listed
below
is
required:
(
1)
Require
all
wettable
powder
products
to
be
packaged
in
water­
soluble
bags
(
an
engineering
control).
(
2)
Require
closed
cockpits
for
aerial
applications.
(
3)
Require
chemical­
resistant
gloves
for
occupational
handlers
performing
the
following
activities:
­
Mixing
and
loading
all
formulations
(
liquids,
wettable
powders,
dry
flowables)
­
Loading
granulars;
­
Making
applications
with
handheld
equipment;
­
Any
activities
which
involve
contact
with
treated
seed
(
including
drying,
raking,
bagging,
and
sewing
bags);
­
Mixing,
loading,
and
applying
when
using
a
tree­
injection
unit;
­
Applying
a
ready­
to­
use
briquette
to
pine
seedlings.
(
4)
Require
both
chemical
resistant
gloves
and
a
chemical
resistant
apron
for
occupational
handlers
performing
the
following
activities:
­
Dipping
pineapples
(
pre­
plant,
and
post­
harvest);
­
Dipping
pine
seed
(
for
on­
nursery
applications).
 
With
the
above
engineering
controls
and
personal
protective
equipment,
risks
to
residential
handlers
are
below
the
Agency's
level
of
concern.

Environmental
Risk
Mitigation
A
number
of
the
mitigation
measures
described
above
will
reduce
exposure
and
risks
to
mammals
and
birds.
These
include:
 
Deleting
all
outdoor
food
uses
of
triadimefon
(
pears,
apples,
grapes,
and
raspberries);
 
Limiting
turf
application
rates
to
a
maximum
single
application
rate
of
2.7
lbs
ai/
A,
and
a
maximum
yearly
rate
of
5.4
lbs
ai/
A
(
reduced
from
no
limit
on
the
number
of
applications);
 
Prohibiting
use
on
residential
turf
(
only
application
to
golf
course
and
sod
farm
turf
will
continue);
 
Limiting
golf
course
applications
to
turf
that
is
less
than
2.5
inches
in
height
(
this
will
reduce
application
to
golf
course
roughs,
which
are
usually
3
or
more
inches
in
height).

Regulatory
Conclusion
 
EPA
has
determined
that
all
supported
uses
of
triadimefon
are
eligible
for
reregistration,
provided
that:
1)
required
product­
specific
data
are
submitted;
2)
risk
mitigation
measures
outlined
in
the
decision
document
are
adopted;
and
3)
label
amendments
are
made
to
reflect
these
measures.
 
The
following
uses
of
triadimefon
are
being
voluntarily
cancelled
by
the
registrant:
all
food
6
uses
(
apples,
pears,
grapes,
and
raspberries),
except
pineapple,
and
residential
turf
use.
The
Agency
will
take
regulatory
action
under
FFDCA
to
revoke
the
associated
tolerances.

 
Risks
for
currently
registered
uses
of
triadimenol
are
below
the
Agency's
level
of
concern,
and
no
further
mitigation
is
required.
The
tolerances
for
triadimenol
are
considered
reassessed.
However,
product­
specific
and
generic
data
are
required
to
be
submitted.

Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
triadimefon
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
the
following
data
requirements
are
necessary
to
confirm
the
reregistration
eligibility
decision
documented
in
the
decision
document:

Human
Health
Effects­
Triadimefon
Guideline
Study
Name
New
OPPTS
Guideline
No.
Developmental
Neurotoxicity
Study
(
DNT)
870.6300
Ecological
Effects­
Triadimefon
Guideline
Study
Name
New
OPPTS
Guideline
No.
Estuarine/
Marine
Fish
LC50
850.1015
Estuarine/
Marine
Mollusk
EC50
850.1025
Estuarine/
Marine
Shrimp
EC50
850.1035
Seedling
Emergence
850.4225
Vegetative
Vigor
850.4250
Aquatic
Vascular
Plant
Growth
850.4400
There
are
data
that
must
be
submitted
to
support
the
continuing
registration
of
triadimenol.
These
data
are
not
expected
to
change
the
regulatory
conclusions
for
triadimenol
described
in
the
decision
document.
A
generic
DCI
will
be
issued
and
will
require
development
and
submission
of
these
listed
data
in
order
to
confirm
the
conclusions
outlined
in
the
decision
document.

Product
Chemistry­
Triadimenol
Guideline
Study
Name
New
OPPTS
Guideline
No.
Stability
830.6313
7
Guideline
Study
Name
New
OPPTS
Guideline
No.
pH
(
H20
solutions)
830.7000
Ultraviolet/
visible
Absorption
830.7050
Partition
Coefficient
(
N­
octanol/
water)
830.7550
830.7560
OR
830.7570
Water
Solubility
830.7840
OR
830.7860
Toxicology­
Triadimenol
Guideline
Study
Name
New
OPPTS
Guideline
No.
Acute
neurotoxicity
study
870.6100
Subchronic
neurotoxicity
Study
870.6200
Residue
Chemistry
 
Separate
metabolism
studies
with
triazole­
14C
and
phenyl­
14C
labeled
triadimenol
applied
as
a
seed
treatment
to
wheat
and
corn
must
be
conducted
to
confirm
residues
of
concern.

 
Storage
stability
data
for
triadimenol,
KWG
1342,
and
KWG
1732
in/
on
field
corn,
sweet
corn,
cotton,
and
wheat
processed
commodities
are
required
pending
the
results
from
the
requested
metabolism
studies.
Storage
stability
data
for
KWG
1732
in/
on
wheat
forage,
hay,
and
straw
are
required
pending
the
results
from
the
requested
metabolism
studies.

 
Crop
field
trial
data
depicting
residues
of
triadimenol,
KWG
1342,
and
KWG
1732
in/
on
field
corn
(
forage,
grain,
stover),
sweet
corn
(
forage,
kernel
plus
cob
with
husks
removed,
grain,
and
stover),
cotton
(
undelinted
seed
and
gin
byproducts),
and
wheat
(
forage,
grain,
hay,
and
straw)
grown
from
seed
treated
at
the
maximum
rate
are
required
pending
the
results
from
the
requested
metabolism
studies.

 
A
wheat
processing
study
conducted
with
triadimenol
applied
to
wheat
as
a
seed
treatment
should
be
submitted
once
the
requested
corn
or
wheat
metabolism
studies
have
been
submitted
and
reviewed.

 
Limited
field
rotational
crop
studies
for
triadimenol
must
be
submitted
pending
the
results
from
the
requested
metabolism
studies.

For
More
Information
8
Electronic
copies
of
the
Triadimefon
RED
and
Tolerance
Reassessment
for
Triadimenol
and
all
supporting
documents
are
available
in
the
Agency's
electronic
docket
on
the
internet
at
http://
www.
regulations.
gov
under
docket
number
EPA­
HQ­
OPP­
20050258
and
EPA­
HQ­
OPP­
2006­
0038,
respectively.

For
more
information
about
EPA's
pesticide
reregistration
program,
the
Triadimefon
RED,
or
reregistration
of
individual
products
containing
triadimefon
and
triadimenol,
please
contact
the
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
US
EPA,
Washington,
DC
20460,
telephone
703­
308­
8000.

For
information
about
the
health
effects
of
pesticides,
or
for
assistance
in
recognizing
and
managing
pesticide
poisoning
symptoms,
please
contact
the
National
Pesticide
Information
Center
(
NPIC).
Call
toll­
free
1­
800­
858­
7378,
from
6:
30
am
to
4:
30
pm
Pacific
Time,
or
9:
30
am
to
7:
30
pm
Eastern
Standard
Time,
seven
days
a
week.
The
NPIC
internet
address
is
http://
npic.
orst.
edu.