United
States
Prevention,
Pesticides
EPA
738­
R­
06­
003
Environmental
Protection
And
Toxic
Substances
August
2006
Agency
(
7508P)
_________________________________________________________________

Reregistration
Eligibility
Decision
for
Triadimefon
And
Tolerance
Reassessment
for
Triadimenol
List
B
Case
No.
2700
Reregistration
Eligibility
Decision
(
RED)
Document
for
Triadimefon
and
Tolerance
Reassessment
for
Triadimenol
Approved
by:
___________________
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
TABLE
OF
CONTENTS
Triadimefon
Reregistration
Eligibility
Decision
Team
............................................................
i
Glossary
of
Terms
and
Abbreviations
.....................................................................................
ii
ABSTRACT
..............................................................................................................................
1
I.
Introduction...................................................................................................................
1
II.
Chemical
Overview
.......................................................................................................
3
A.
Regulatory
History
........................................................................................................
3
B.
Chemical
Identification.................................................................................................
4
1.
Technical
Triadimefon
..................................................................................................
4
2.
Triadimenol
...................................................................................................................
5
3.
Triazole
Metabolites......................................................................................................
5
a.
1,2,4­
Triazole
..........................................................................................................
6
b.
Triazole
Alanine
.....................................................................................................
6
c.
Triazole
Acetic
Acid...............................................................................................
6
C.
Use
Profile.....................................................................................................................
7
1.
Triadimefon...................................................................................................................
7
2.
Triadimenol...................................................................................................................
8
D.
Estimated
Usage
of
Pesticide........................................................................................
9
1.
Triadimefon
..................................................................................................................
9
2.
Triadimenol
..................................................................................................................
9
III.
Summary
of
Risk
Assessments....................................................................................
9
A.
Human
Health
Risk
Assessment
...............................................................................
10
1.
Toxicity
of
Triadimefon
and
Triadimenol...............................................................
11
a.
Acute
Toxicity
Profile
.........................................................................................
11
b.
FQPA
Special
Safety
Factor
Considerations.....................................................
13
c.
Toxicological
Endpoints......................................................................................
13
2.
Carcinogenicity.........................................................................................................
15
3.
Endocrine
Effects......................................................................................................
16
4.
Dietary
Exposure
and
Risk
......................................................................................
16
a.
Dietary
(
Food)
Risk
Assessment.........................................................................
17
1)
Acute
Dietary
Food
Risk
................................................................................
17
2)
Chronic
Dietary
Food
Risk
............................................................................
18
b.
Dietary
Exposure
from
Drinking
Water
...........................................................
19
c.
Dietary
Risk
from
Drinking
Water....................................................................
20
1)
Acute
Dietary
Water
Risk
..............................................................................
20
2)
Chronic
Dietary
Water
Risk
..........................................................................
21
5.
Residential
(
Non­
dietary)
Exposure
and
Risk.........................................................
22
a.
Residential
Handler
Risk....................................................................................
22
b.
Residential
Post­
application
Exposure
and
Risks
.............................................
24
6.
Aggregate
Exposure/
Risk
from
Triadimefon
and
Triadimenol
.............................
25
7.
Pesticide
and
Pharmaceutical
Co­
Exposure
Assessment
for
the
Triazole
Metabolites...............................................................................................................
28
8.
Cumulative
Risk
Assessment
...................................................................................
29
9.
Occupational
Risk
....................................................................................................
29
a.
Occupational
Toxicity..........................................................................................
30
b.
Occupational
Handler
Exposure.........................................................................
31
c.
Occupational
Handler
Risk
Summary................................................................
32
d.
Occupational
Post­
application
Risk
Summary
..................................................
37
10.
Human
Incident
Data...............................................................................................
37
B.
Environmental
Fate
and
Effects
Risk
Assessment
..................................................
38
1.
Environmental
Fate
and
Transport.........................................................................
39
2.
Ecological
Exposure
and
Risk..................................................................................
39
a.
Aquatic
Organism
Exposure
and
Risk
...............................................................
40
1)
Fish,
Invertebrate,
and
Aquatic
Plant
Toxicity............................................
40
2)
Fish
and
Invertebrate
Exposure
...................................................................
42
3)
Fish
and
Invertebrate
Risk............................................................................
43
4)
Non­
target
Aquatic
Plants.............................................................................
43
b.
Terrestrial
Organism
Exposure
and
Risk
.........................................................
44
1)
Bird
and
Mammal
Toxicity...........................................................................
44
2)
Bird
and
Mammal
Exposure.........................................................................
46
3)
Bird
and
Mammal
Risk.................................................................................
46
4)
Non­
target
Terrestrial
Plants........................................................................
48
5)
Non­
target
Insects..........................................................................................
49
3.
Ecological
Incidents..................................................................................................
49
4.
Endangered
Species........................................................................................................
49
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
...........
49
A.
Determination
of
Reregistration
Eligibility
and
Tolerance
Reassessment.............
49
B.
Public
Comments
and
Responses.............................................................................
50
C.
Regulatory
Position
under
the
FFDCA
...................................................................
50
1.
Food
Quality
Protection
Act
Findings.....................................................................
50
a.
"
Risk
Cup"
Determination..................................................................................
50
b.
Determination
of
Safety
to
U.
S.
Population.......................................................
51
c.
Determination
of
Safety
to
Infants
and
Children
..............................................
51
d.
Endocrine
Disruptor
Effects
..............................................................................
51
e.
Cumulative
Risks................................................................................................
52
2.
Tolerance
Summary
for
Triadimefon......................................................................
52
a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.410......................................
52
b.
Codex
Harmonization
........................................................................................
55
c.
Residue
Analytical
Methods
 
Plants/
Livestock................................................
55
3.
Tolerance
Summary
for
Triadimenol.....................................................................
56
a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.450.......................................
56
D.
Regulatory
Rationale................................................................................................
58
1.
Human
Health
Risk
Management
...........................................................................
59
a.
Dietary
(
Food
and
Water)
Risk
Mitigation........................................................
59
b.
Residential
Risk
Mitigation................................................................................
59
c.
Occupational
Risk
Mitigation
............................................................................
60
d.
Aggregate
Risk
Mitigation
for
Triazole
Metabolites.........................................
61
2.
Environmental
Risk
Mitigation
...............................................................................
61
3.
Other
Labeling
.........................................................................................................
61
4.
Endangered
Species
Program..................................................................................
61
V.
What
Registrants
Need
to
Do..................................................................................
62
A.
Manufacturing
Use
Products
..................................................................................
64
1.
Generic
Data
Requirements
for
Triadimefon
........................................................
64
2.
Labeling
for
Manufacturing
Use
Products.............................................................
65
B.
End­
Use
Products
....................................................................................................
65
1.
Additional
Product­
Specific
Data
Requirements
...................................................
65
2.
Labeling
for
End­
Use
Products...............................................................................
65
C.
Data
Requirements
for
Triadimenol.......................................................................
65
D.
Labeling
Changes
Summary
Table.........................................................................
66
VI.
Appendices...............................................................................................................
79
A.
Use
Patterns
Subject
to
Reregistration
for
Triadimefon
.......................................
83
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
...........................................................................................
83
C.
Technical
Support
Documents
................................................................................
94
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
Reregistration
Eligibility
Decision
(
Bibliography)
for
Triadimefon
and
Triadimenol
.................
97
E.
Generic
Data
Call­
In.............................................................................................
114
F.
Product
Specific
Data
Call­
In...............................................................................
116
G.
Batching
of
Triadimenol/
Triadimefon
Products.................................................
118
H.
List
of
Registrants
Sent
this
Data
Call­
In............................................................
122
I.
List
of
Available
Related
Documents
and
Electronically
Available
Forms
.......
123
i
Triadimefon
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs:

Biological
and
Economic
Analysis
Assessment
Andrew
Lee
Jenna
Carter
Jin
Kim
Tara
Chandgoyal
Environmental
Fate
and
Effects
Risk
Assessment
Michelle
Embry
Jonathan
Angier
Fred
Jenkins
Dana
Spatz
Health
Effects
Risk
Assessment
Samuel
Ary
Judy
Facey
Shanna
Recore
Richard
Griffin
Michael
Doherty
Alan
Nielsen
Sheila
Piper
Yvonne
Barnes
Registration
Support
Tony
Kish
Risk
Management
John
W.
Pates,
Jr.
Kelly
Sherman
Veronique
LaCapra
Office
of
General
Counsel
Erin
Koch
ii
Glossary
of
Terms
and
Abbreviations
AGDCI
Agricultural
Data
Call­
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
BCF
Bioconcentration
Factor
CFR
Code
of
Federal
Regulations
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
EEC
Estimated
Environmental
Concentration
EPA
Environmental
Protection
Agency
EUP
End­
Use
Product
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLN
Guideline
Number
HAFT
Highest
Average
Field
Trial
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOC
Level
of
Concern
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
Fg/
g
Micrograms
Per
Gram
Fg/
L
Micrograms
Per
Liter
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
iii
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MUP
Manufacturing­
Use
Product
NA
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
NOAEL
No
Observed
Adverse
Effect
Level
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SAP
Science
Advisory
Panel
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TGAI
Technical
Grade
Active
Ingredient
TRR
Total
Radioactive
Residue
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UF
Uncertainty
Factor
UV
Ultraviolet
WPS
Worker
Protection
Standard
1
ABSTRACT
The
Environmental
Protection
Agency
(
EPA
or
the
Agency)
has
completed
the
human
health
and
environmental
risk
assessments
for
triadimefon
and
the
dietary
and
aggregate
assessments
for
triadimenol,
and
is
issuing
its
risk
management
reregistration
decision
and
tolerance
reassessment.
The
risk
assessments,
which
are
summarized
below,
are
based
on
the
review
of
the
required
target
database
supporting
the
use
patterns
of
currently
supported
products
and
additional
information
received
through
the
public
docket.

The
Agency
discussed
the
dietary
risks
of
concern
(
food
+
water)
with
the
registrant,
and
the
registrant
has
proposed
a
number
of
changes
to
its
triadimefon
registration
including
the
voluntary
deletion
of
all
food
(
except
pineapples)
and
residential
turf
use,
and
a
reduction
of
application
rates
and
frequencies.
In
doing
so,
this
document
has
estimated
exposure
and
risk
based
on
these
new
use
patterns.

After
considering
the
risks
identified
in
the
revised
risk
assessments,
comments
received,
and
mitigation
suggestions
from
interested
parties,
the
Agency
developed
its
risk
management
reregistration
decision
for
uses
of
triadimefon
and
tolerance
reassessment
for
triadimenol.
As
a
result
of
this
review,
EPA
has
determined
that
triadimefon­
containing
products
are
eligible
for
reregistration,
provided
that
risk
mitigation
measures
are
adopted
and
labels
are
amended
accordingly.
Furthermore,
the
tolerances
for
triadimefon
and
triadimenol
are
considered
reassessed
and
regulatory
action
under
the
Federal
Food,
Drug
and
Cosmetic
Act
("
FFDCA")
will
occur
after
the
uses
that
do
not
meet
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
("
FIFRA")
standard
are
canceled.
These
decisions
are
discussed
fully
in
this
document.

I.
Introduction
FIFRA
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
a
review
of
all
submitted
data
by
the
EPA.
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
risks
arising
from
the
currently
registered
uses
of
the
pesticide,
to
determine
the
need
for
additional
data
on
health
and
environmental
effects,
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
and
the
FFDCA
to
require
reassessment
of
all
existing
tolerances
for
pesticides
in
food.
FQPA
also
requires
EPA
to
review
all
tolerances
in
effect
on
August
2,
1996,
by
August
3,
2006.
In
reassessing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
When
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern
and
the
Agency
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure,
the
tolerances
are
considered
2
reassessed.
EPA
decided
that,
for
those
chemicals
that
have
tolerances
and
are
undergoing
reregistration,
tolerance
reassessment
will
be
accomplished
through
the
reregistration
process.
As
mentioned
above,
FFDCA
requires
that
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity"
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance.
Potential
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity
are
considered
because
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
of
toxicity
could
lead
to
the
same
adverse
health
effect
that
would
occur
at
a
higher
level
of
exposure
to
any
one
of
these
individual
chemicals.
Triadimefon
belongs
to
a
group
of
pesticides
called
triazoles
(
or
conazoles),
which
also
includes
the
triazole
fungicide
subject
to
reregistration,
propiconazole.
Triadimenol,
a
metabolite
of
triadimefon,
is
also
a
registered
fungicide
and
is
subject
to
tolerance
reassessment.
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.
However,
the
triazole
fungicides
share
common
metabolites,
the
triazole
compounds
1,2,4­
triazole
(
free
triazole),
triazole
alanine,
and
triazole
acetic
acid,
which
are
considered
in
this
document.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative.

The
Agency
has
identified
triazole
metabolites
of
toxicological
concern;
these
include
1,2,4­
triazole
and
the
conjugates
triazole
alanine
and
triazole
acetic
acid.
Because
these
metabolites
are
formed
from
all
triazole
pesticides,
EPA
has
conducted
a
separate
toxicology
assessment
for
these
compounds
and
concluded
that
the
existing
data
are
sufficient
to
support
the
reregistration
of
triadimefon
and
triadimenol.
For
more
details
on
the
toxicity
of
the
free
triazoles,
see
the
August
5,
2003,
documents,
TRIAZOLES
 
Report
of
the
Ad
Hoc
HED
Peer
Review
Committee,
TRIAZOLES
 
2nd
Report
of
the
Ad
Hoc
HED
Peer
Review
Committee,
and
the
February
7,
2006,
document,
1,2,4­
Triazole,
Triazole
Alanine,
Triazole
Acetic
Acid:
Human
Health
Aggregate
Risk
Assessment
in
Support
of
Reregistration
and
Registration
Actions
for
Triazole­
derivative
Fungicide
Compounds,
which
are
available
under
docket
number
EPA­
HQ­
OPP­
2005­
0258.
Because
the
risks
associated
with
the
free
triazoles
are
all
below
the
Agency's
level
of
concern,
they
are
not
discussed
further
in
this
document.
For
more
information
regarding
the
aggregate
assessment
of
free
triazoles,
see
the
July
18,
2006,
document,
Reregistration
Eligibility
Decision
(
RED)
for
Propiconazole,
in
the
Agency's
electronic
docket
on
the
internet
at
http://
www.
regulations.
gov
under
docket
number
EPAHQ
OPP­
2005­
0497.

Triadimefon
and
triadimenol
also
share
a
common
metabolite,
1,2,4­
triazole,
with
several
triazole­
derivative
pharmaceutical
compounds.
Thus,
EPA
must
consider
the
incremental
impact
of
exposure
to
1,2,4­
triazole
pesticide
residues
to
individuals
using
triazole­
derivative
pharmaceutical
products.
To
this
end,
EPA
worked
with
the
U.
S.
Food
and
Drug
Administration
(
FDA),
which
has
regulatory
authority
for
drug
products,
to
assess
3
the
risks
posed
by
1,2,4­
triazole
residues
that
could
result
from
concurrent
exposure
to
triazole­
derivative
pharmaceutical
and
pesticide
products.
This
assessment
will
provide
the
basis
of
safety
findings
reflecting
the
joint
perspectives
of
FDA
and
EPA,
and
will
inform
a
decision
by
both
Agencies
about
whether
appropriate
measures
are
needed
to
reduce
exposure
from
one
or
both
sources
of
1,2,4­
triazole
residues.

This
document
presents
a
summary
of
EPA's
revised
human
health
and
ecological
risk
assessments,
its
reregistration
eligibility
decision
for
triadimefon
and
tolerance
reassessment
decision
for
triadimenol.
Occupational
and
ecological
risks
from
exposure
to
the
pesticidal
uses
of
triadimenol
are
not
addressed
in
this
document.
The
document
consists
of
six
sections.
Section
I
contains
the
regulatory
framework
for
reregistration/
tolerance
reassessment.
Section
II
provides
a
profile
of
the
use
and
usage
of
the
chemicals.
Section
III
gives
an
overview
of
the
revised
human
health
and
environmental
effects
risk
assessments
based
on
data,
public
comments,
and
other
information
received
in
response
to
the
preliminary
risk
assessments.
Section
IV
presents
the
Agency's
reregistration
eligibility,
risk
management
and
tolerance
reassessment
decisions.
Section
V
summarizes
label
changes
necessary
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV.
Finally,
the
Appendices
list
related
and
supporting
documents.
The
revised
risk
assessments
for
triadimefon
and
triadimenol
are
available
in
the
Agency's
electronic
docket
on
the
internet
at
http://
www.
regulations.
gov
under
docket
number
EPA­
HQ­
OPP­
2005­
0258
and
EPA­
HQOPP
2006­
0038,
respectively.

II.
Chemical
Overview
A.
Regulatory
History
Triadimefon
Triadimefon
is
a
broad
spectrum,
systemic
fungicide
used
to
control
rust
and
mildew
on
apples,
grapes,
pears,
pineapples,
and
raspberries.
In
addition,
it
is
used
to
control
various
fungal
diseases
on
non­
food
use
sites
such
as
pine
seedlings,
Christmas
trees,
residential
and
commercial
turf,
ornamentals,
and
landscapes.
There
are
tolerances
for
triadimefon
on
apples,
grapes,
pears,
pineapples,
and
raspberries.
Triadimefon
end­
use
products
are
marketed
in
the
United
States
under
the
trade
names
Bayleton
and
Summit.
There
are
nineteen
active
products
containing
triadimefon
(
one
technical
product)
registered
under
Section
3
of
FIFRA.

The
registrant
has
agreed
to
delete
all
food
(
except
pineapple)
and
residential
turf
uses.
Therefore,
this
Reregistration
Eligibility
Decision
document
evaluates
risks
from
all
currently
supported
uses
of
triadimefon.
The
Agency
will
follow
the
FIFRA
cancellation
with
the
appropriate
tolerance
revocations.

Triadimenol
The
primary
metabolite
of
triadimefon
is
triadimenol.
Triadimenol,
which
degrades
to
include
the
metabolites
KWG
1323
and
KWG
1342,
is
also
registered
separately
as
a
broad
spectrum,
systemic
fungicide
under
its
own
active
ingredient
number
(
PC
code:
4
127201).
Triadimenol
is
used
exclusively
in
the
U.
S.
as
a
seed
treatment
for
cotton
and
grains.
As
a
result,
it
is
also
being
assessed
by
the
Agency
for
the
purposes
of
a
tolerance
reassessment
eligibility
decision
(
TRED).
Triadimenol
was
first
registered
after
1984
and
is
not
subject
to
reregistration
under
the
1988
amendments
to
FIFRA.

B.
Chemical
Identification
1.
Technical
Triadimefon
O
N
N
N
Cl
O
C(
CH
3
)
3
Common
Name:
Triadimefon
Chemical
Name:
1­(
4­
chlorophenoxy)­
3,3­
dimethyl­
1­(
1H­
1,2,4­
triazol­
1­
yl)­
2­
butanone
Chemical
Family:
Azole
(
Triazoles)

Empirical
Formula:
C14H16CLN3O2
CAS
Registry
Number:
43121­
43­
3
Case
Number:
2700
OPP
Chemical
Code:
109901
Molecular
weight:
293.75
g/
mol
Trade
Names:
Bayleton
and
Summit
Basic
Manufacturers:
Bayer
CropScience,
LC
Triadimefon
has
a
melting
point
of
82.3
degrees
Celsius,
a
solubility
of
64
mg/
L
ppm
in
water
20
degrees
Celsius
and
a
vapor
pressure
of
0.2
 
0.6
mPa
at
20
and
25
degrees
Celsius,
respectively
(
7.6
x
10­
7
mm
Hg).
5
2.
Triadimenol
Common
Name:
Triadimenol
Chemical
Name:
[
beta­(
4­
chlorophenoxy)­
alpha­(
1,1­
dimethylethyl)­
1H­
1,2,4­
triazole­
1­
ethanol]

Chemical
Family:
Azole
(
Triazoles)

Empirical
Formula:
C14H18ClN3O2
CAS
Registry
Number:
55219­
65­
3
Case
Number:
2700
OPP
Chemical
Code:
127201
Molecular
weight:
295.77
g/
mol
Trade
Names:
Baytan
Basic
Manufacturers:
Bayer
CropScience,
LC
3.
Triazole
Metabolites
Triadimefon,
triadimenol,
and
other
triazole
fungicides
are
metabolized
in
animals
and
plants
to
form
compounds
containing
the
triazole
moiety,
including
1,2,4­
triazole
(
free
triazole),
triazole
alanine,
and
triazole
acetic
acid,
which
are
also
considered
in
this
decision.
Since
triazole
alanine
and
triazole
acetic
acid
are
formed
by
conjunction
with
an
amino
acid,
they
are
referred
to
as
triazole
conjugates
throughout
this
document.
Chemical
information
for
these
triazole
metabolites
is
provided
below.
6
a.
1,2,4­
Triazole
NH
N
N
Chemical
Name:
1,2,4­
Triazole
Common
Name(
s):
1,2,4­
T;
free
triazole
CAS
Number:
288­
88­
0
PC
Code:
600074
Molecular
Weight:
69.07
b.
Triazole
Alanine
N
N
N
NH2
O
OH
Chemical
Name:
Triazole
Alanine
(
TA)
CAS
No.:
86362­
20­
1
PC
Code:
600011
Molecular
Weight:
156.15
c.
Triazole
Acetic
Acid
N
N
N
O
OH
Chemical
Name:
Triazole
Acetic
Acid
(
TAA)
CAS
No.:
28711­
29­
7
PC
Code:
600082
Molecular
Weight:
127.10
7
C.
Use
Profile
1.
Triadimefon
The
following
is
information
on
the
currently
registered
uses
of
triadimefon,
including
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
triadimefon
eligible
for
reregistration
is
contained
in
Appendix
A.

Type
of
Pesticide:
Broad
spectrum,
systemic
fungicide;
demethylation
inhibitor
(
DMI).

Summary
of
Use:
Used
for
the
systemic
control
of
various
fungal
diseases
in
fruits,
turf,
pine
seedlings,
Christmas
trees,
and
ornamentals.

Food
uses:
Apples,
grapes,
pears,
pineapples,
and
raspberries.
(
Registrant
is
voluntarily
deleting
use
on
apples,
grapes,
pears,
and
raspberries).

Non­
food
uses:
Pine
seedlings,
Christmas
trees,
residential
and
commercial
turf,
ornamentals,
and
landscapes.
(
Registrant
is
voluntarily
deleting
residential
turf
use).

Formulation
Type:
Registered
formulations
include
granular
(
G)(
0.5­
1%
active
ingredient),
wettable
powder
(
WP)(
25­
50%
active
ingredient),
water
soluble
packets
(
50%
active
ingredient),
liquid
concentrate
(
LC)(
0.88%
active
ingredient),
and
ready­
to­
use
(
RTU)(
0.5%
active
ingredient).

Registrant(
s):
Bayer
CropScience,
LP
Method
and
Rates
of
Application:

Application
Methods:
Applied
via
ground
spray,
airblast,
aerial
spray
,
chemigation,
and
broadcast
(
granular
only)
to
apples,
pears,
raspberries,
grapes,
Christmas
trees,
ornamentals,
pine
seedlings,
and
turf
(
golf
course,
residential,
commercial,
and
recreational).
It
is
also
used
as
a
postharvest
dip
for
pineapples
and
as
a
seed­
piece
treatment
prior
to
planting.
It
is
also
used
to
treat
pine
seeds
via
dip,
soak,
or
traditional
seed
treatment.

Application
Rates:
The
registrant
has
agreed
to
voluntarily
delete
all
food
(
except
pineapple)
and
residential
turf
use.
8
Current
maximum
application
rates
are
a
5.4
lb.
ai/
A
treatment
on
turf
(
California
only)
and
a
2.7
lb.
ai/
A
treatment
on
turf
outside
of
California.
A
maximum
rate
of
0.75
lbs
ai/
A
may
be
used
as
a
pre­
harvest
foliar
treatment
on
apples
and
pears
(
up
to
12X
per
season),
0.56
lbs
ai/
A
for
grapes
(
up
to
6X
per
season),
and
0.88
lbs
ai/
A
for
raspberries
(
up
to
7X
per
season).
A
maximum
rate
of
2.0
lbs
ai/
A
may
be
used
for
preharvest
foliar
treatment
on
both
Christmas
trees
(
up
to
8X
per
season)
and
pine
seedlings
(
up
to
16X
per
season).
For
pineapple,
a
maximum
rate
of
0.28
lbs
ai/
100
gallons
solutions
may
be
applied
via
dip
and
at
a
maximum
rate
of
0.28
lbs
ai/
100
gallons
solution
via
dip
or
spray
to
the
whole
fruit
following
harvest.
It
is
also
used
as
a
pine
seed
soak
(
0.63
lbs
ai/
100
gal
solution),
and
as
a
pine
seed
treatment
(
0.063
lbs
ai/
100
gal
solution,
one
time
prior
to
planting.

Application
Timing:
Applied
pre­
plant,
foliar
and
post­
harvest.

Use
Classification:
General
2.
Triadimenol
The
following
is
information
on
the
currently
registered
uses
of
triadimenol,
including
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
triadimenol
eligible
for
tolerance
reassessment
is
contained
in
Appendix
A.

Type
of
Pesticide:
Systemic
fungicide
for
seed
treatment.

Summary
of
Use:
Used
as
a
seed
treatment
on:
barley,
corn,
cotton,
oats,
rye,
sorghum,
and
wheat.
There
is
also
an
import
tolerance
on
bananas.

Formulation
Type:
Registered
formulations
include
emulsifiable
concentrate
(
EC)
(
5%
active
ingredient),
wettable
powder
(
WP)(
25%
active
ingredient),
soluble
concentrate
(
SC)
(
13.33%
active
ingredient),
and
flowable
concentrate
(
FlC)
(
28.3
­
30%
active
ingredient).

Registrant(
s):
Bayer
CropScience,
LP
Method
and
Rates
of
Application:
9
Application
Rates:
The
maximum
use
rates,
adjusted
for
planting,
range
from
0.006
to
0.0375
lbs.
ai/
A
(
0.007­
0.042
kg
ai/
ha)
for
one
season.

Application
Timing:
Applied
pre­
plant.

Use
Classification:
General
D.
Estimated
Usage
of
Pesticide
1.
Triadimefon
Screening
level
estimates
of
triadimefon
use
in
the
U.
S.,
based
on
data
from
the
years
1990
through
2000,
have
been
provided
by
the
Agency's
Biological
and
Economic
Analysis
Division.
Total
use
averaged
135,000
lbs
ai/
year
with
an
upper­
end
estimate
of
266,000
lbs
ai/
year.
The
largest
market,
in
terms
of
total
pounds
ai,
was
seen
in
the
turf
and
ornamental
sector.

2.
Triadimenol
Based
on
pesticide
usage
data
for
the
years
1992
through
2001,
total
annual
domestic
usage
of
triadimenol
averaged
approximately
24,000
pounds
of
active
ingredient
(
a.
i.)
for
over
12,000,000
acres
treated.
Use
on
cotton
accounted
for
approximately
75
%
of
the
total
pounds
of
a.
i.
applied
annually.
Corn
and
wheat
accounted
for
approximately
20%
and
5%,
respectively.
About
80%
of
U.
S.
acreage
planted
to
cotton
is
treated
with
triadimenol,
and
less
than
1
%
of
corn
and
wheat
acres
are
treated
III.
Summary
of
Risk
Assessments
The
following
is
a
summary
of
EPA's
human
health
and
ecological
risk
findings
and
conclusions
for
triadimefon
and
triadimenol,
as
presented
fully
in
the
documents:

Triadimefon
 
Triadimefon.
Preliminary
Human
Health
Risk
Assessment
(
Revised).
February
9,
2006
 
Triadimefon/
Triadimenol:
Summary
of
Refinements
and
Revisions
to
the
Human
Health
Risk
Assessment.
July
10,
2006
 
Triadimefon:
Revised
Acute,
Probabilistic
and
Chronic
Dietary
(
Food
+
Drinking
Water)
Exposure
and
Risk
Assessments
for
the
Triadimefon
Reregistration.
July
6,
2006
 
Environmental
Fate
and
Effects
Chapter
(
Revised),
Risk
Assessment
for
Triadimefon.
January
19,
2006
 
Triadimefon:
HED
Response
to
Comments
Received
During
the
Public
Comment
Phase.
June
20,
2006
 
Memo:
EFED
Revisions
to
the
Ecological
Risk
Assessment.
August
3,
2006
10
 
Triadimefon.
Summary
of
Ana­­
lytical
Chemistry
and
Residue
Data
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
November
23,
2005
 
Triadimefon:
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document.
June
30,
2006
 
Triadimefon
and
Triadimenol:
Aggregate
Acute,
Chronic,
and
Short­
Term
Risk
Assessments
Reflecting
July,
2006
Risk
Mitigation
in
Response
to
the
Phase
4
Triadimefon
RED.
August
1,
2006
 
Response
to
Bayer
Public
Comments
Regarding
the
Environmental
Fate
and
Effects
Division
Triadimefon
Risk
Assessment.
June
1,
2006
 
Tier
2
Drinking
Water
Assessment
for
Triadimefon
and
its
Major
Degradate
Triadimenol.
August
31,
2005
Triadimenol
 
Triadimenol:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
(
Revised).
February
9,
2006
 
Triadimenol.
Acute
and
Chronic
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
November
18,
2005
The
purpose
of
this
section
is
to
summarize
the
key
features
and
findings
of
the
risk
assessments
in
order
to
help
the
reader
better
understand
the
risk
management
decisions
reached
by
the
Agency.
The
human
health
and
ecological
risk
assessment
documents
and
supporting
information
listed
in
Appendix
C
were
used
to
reach
the
safety
finding
and
regulatory
decisions
for
triadimefon
and
triadimenol.
Although
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
from
the
OPP
Public
Docket
OPP­
2005­
0258
and
OPP­
2006­
0038,
and
may
also
be
accessed
on
the
web
at
http://
www.
regulations.
gov.
Hard
copies
of
these
documents
may
be
found
in
the
OPP
public
docket
under
these
same
docket
numbers.

A.
Human
Health
Risk
Assessment
The
human
health
risk
assessment
incorporates
potential
exposure
from
all
sources,
which
for
triadimefon
includes
food,
drinking
water,
residential,
and
occupational
scenarios
and
for
triadimenol
include
food
and
drinking
water
scenarios.
Aggregate
assessments
combine
food,
drinking
water,
and
any
residential
or
other
non­
occupational
(
if
applicable)
exposures
to
determine
potential
exposures
to
the
U.
S.
population.

This
document
summarizes
risk
estimates
for
triadimefon
(
including
its
metabolite
triadimenol
and
degradates
KWG
1342
and
KWG
1732),
and
its
metabolites
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid,
which
are
formed
from
triazole
compounds
in
animals
and
plants
and
may
be
found
in
food
commodities,
including
animal
byproducts.
1,2,4­
Triazole
appears
to
be
relatively
stable
in
the
environment,
and
may
be
found
in
rotational
crops
and
drinking
water.
A
surface
water
monitoring
study
showed
detections
of
1,2,4­
triazole
in
a
small
number
of
samples.
Therefore,
EPA
has
considered
the
risks
from
food,
drinking
water
and
non­
occupational
exposure
resulting
from
triadimefon
alone
and
11
from
the
triazole
metabolites
from
all
pesticide
sources.
For
triadimenol,
since
there
are
no
residential
uses,
EPA
considered
exposure
and
risk
from
food
and
drinking
water
In
addition,
EPA
has
also
considered
potential
co­
exposure
to
free
triazoles
resulting
from
pharmaceutical
uses
of
triazole
compounds.
Because
the
risks
associated
with
the
free
triazoles
from
all
sources
are
all
below
the
Agency's
level
of
concern,
they
are
not
discussed
further
in
this
document.
Additional
details
regarding
the
risks
associated
with
the
free
triazoles,
which
includes
contribution
from
triadimefon
and
triadimenol,­
may
be
found
in
the
February
7,
2006,
document,
1,2,4­
Triazole,
Triazole
Alanine,
Triazole
Acetic
Acid:
Human
Health
Aggregate
Risk
Assessment
in
Support
of
Reregistration
and
Registration
Actions
for
Triazole
Derivative
Fungicide
Compounds,
which
is
available
in
the
public
docket
(
EPA­
HQ­
OPP­
2005­
0258).

1.
Toxicity
of
Triadimefon
and
Triadimenol
Toxicity
assessments
are
designed
to
predict
whether
a
pesticide
could
cause
adverse
health
effects
in
humans
(
including
short­
term
or
acute
effects
such
as
skin
or
eye
damage,
and
lifetime
or
chronic
effects
such
as
cancer,
developmental
and/
or
reproductive
effects),
and
the
level
or
dose
at
which
such
effects
might
occur.
The
Agency
has
reviewed
all
toxicity
studies
submitted
and
has
determined
that
the
toxicity
database
for
triadimefon
is
adequate
although
there
are
data
gaps
(
lack
of
a
developmental
neurotoxicity
study
which
the
Agency
will
remedy
through
the
DCI).
In
addition,
the
Agency
has
reviewed
all
toxicity
studies
submitted
for
triadimenol
and
has
determined
that
the
database
is
adequate.
The
triadimenol
data
base
is
less
definite
than
triadimefon;
however,
because
it
is
a
metabolite
of
triadimefon
the
Agency
believes
that
the
use
of
data
on
triadimefon
can
be
used
for
triadimenol
and
be
protective
regarding
any
potential
risk
concerns.
But
the
Agency
is
requiring
data
to
confirm
this
decision.
However,
pending
the
results
of
both
the
acute
and
subchronic
neurotoxicity
studies,
the
Agency
is
not
requiring
a
developmental
neurotoxicity
(
DNT)
study
for
triadimenol
at
this
time.
All
other
studies
have
been
submitted
to
support
guideline
requirements
and
a
reregistration
eligibility
determination
for
all
currently
registered
uses.
For
more
details
on
the
toxicity
of
triadimefon,
see
the
February
9,
2006,
document,
Triadimefon.
Preliminary
Human
Health
Risk
Assessment
(
Revised),
and
the
July
10,
2006,
document,
Triadimefon/
Triadimenol:
Summary
of
Refinements
and
Revisions
to
the
Human
Health
Risk
Assessment,
which
is
available
under
docket
number
EPA­
HQ­
OPP­
2005­
0258.

a.
Acute
Toxicity
Profile
Triadimefon
Triadimefon
is
classified
as
category
III
for
acute
oral
and
dermal
toxicity
and
as
category
IV
for
acute
inhalation.
It
is
also
classified
as
category
IV
for
eye
irritation
potential
and
category
IV
for
skin
irritation
potential.
In
addition,
triadimefon
caused
dermal
sensitization
in
guinea
pigs.
The
acute
toxicity
profile
for
technical
grade
triadimefon
is
summarized
in
Table
1
below.
The
technical
acute
toxicity
values
included
in
this
document
are
only
to
provide
background
information.
Additional
acute
toxicity
data
may
be
required
to
determine
appropriate
cautionary
label
language
for
products
containing
triadimefon.
12
Table
1.
Acute
Toxicity
Profile
for
Triadimefon
Old
Guideline
No.
New
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
81­
1
870.1100
Acute
Oral
­
rat
264276
LD50
=
1,470
mg/
kg
(
Males)

LD50
=
1,090
mg/
kg
(
Females)
III
81­
2
870.1200
Acute
Dermal
­
Rabbit
264276
LD50
>
2,000
mg/
kg
III
81­
3
870.1300
Acute
Inhalation
­
rat
41616002
LC50
>
3.570
mg/
L
IV
81­
4
870.2400
Acute
(
Primary)
Eye
Irritation
­
rabbit
41782501
Slightly
irritating
IV
81­
5
870.2500
Acute
(
Primary)
Dermal
(
Skin)
Irritation
­
rabbit
41616004
Not
an
irritant
IV
81­
6
870.2600
Skin
(
Dermal)
Sensitization
 
guinea
pig
41554001
Sensitizer
Not
Applicable
Triadimenol
Triadimenol
shows
low
toxicity
for
acute
oral,
dermal,
and
inhalation
exposure
(
toxicity
Category
III
or
IV)
and
is
not
a
skin
sensitizer.
Triadimenol
is
an
eye
irritant
with
irritation
clearing
in
21
days
or
longer
(
toxicity
Category
II),
and
is
a
mild
dermal
irritant
(
toxicity
Category
IV).
The
acute
toxicity
profile
for
technical
triadimenol
is
summarized
in
Table
2
below.

Table
2:
Acute
Toxicity
Profile
for
Triadimenol
Old
Guideline
No.
New
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
81­
1
870.1100
Acute
oral
 
rat
00125411
LD50
=
689
mg/
kg
(
males)
LD50
=
752
mg/
kg
(
females)
III
81­
2
870.1200
Acute
dermal
 
rabbit
00145086
LD50
>
2000
mg/
kg
III
81­
3
870.1300
Acute
inhalation
 
rat
00145087
LC50
>
2.58
mg/
L
(
Limit
Dose)
IV
81­
4
870.2400
Acute
eye
irritation
 
rabbit
00145088
eye
irritant.
Irritation
cleared
in
21
days
or
longer.
II
81­
5
870.2500
Acute
dermal
irritation
 
rabbit
00145088
mild
skin
dermal
irritation
IV
81­
6
870.2600
Skin
sensitizationguinea
pig
00125413
Not
a
skin
sensitizer
Not
Applicable
13
b.
FQPA
Safety
Factor
Considerations
The
FFDCA
as
amended
by
the
FQPA
directs
the
Agency,
in
setting
pesticide
tolerances,
to
use
an
additional
tenfold
(
10X)
margin
of
safety
to
protect
infants
and
children,
taking
into
account
the
potential
for
pre­
and
post­
natal
toxicity
and
the
completeness
of
the
toxicology
and
exposure
databases.
The
statute
authorizes
the
Agency
to
reduce
this
tenfold
FQPA
safety
factor
(
SF)
only
if
reliable
data
demonstrate
that
the
resulting
level
of
exposure
would
be
safe
for
infants
and
children.

Triadimefon
The
current
developmental
and
reproductive
toxicity
studies
do
not
suggest
that
the
young
are
more
sensitive
than
adult
animals.
However,
since
the
triadimefon
database
does
not
include
a
DNT
study,
an
FQPA
safety
factor
for
database
uncertainty
(
10X)
has
been
retained
for
exposure
scenarios
through
which
exposure
to
children
or
pregnant
women
is
expected.
A
DNT
study
is
required
for
triadimefon
and
the
Agency
will
issue
a
DCI
for
this
data.

Triadimenol
The
endpoint
of
concern
for
triadimenol,
like
triadimefon,
is
neurotoxicity,
which
was
observed
in
rat,
mice,
and
rabbit
studies.
Evidence
of
increased
susceptibility
to
offspring
was
not
seen
in
available
developmental
toxicity
studies
in
two
species
(
rabbits
and
rats)
and
in
a
two­
generation
reproductive
toxicity
study
in
rats.
Therefore,
the
Agency
is
not
requiring
a
developmental
neurotoxicity
(
DNT)
study
for
triadimenol
at
this
time,
pending
the
results
of
the
acute
and
subchronic
neurotoxicity
studies
listed
in
section
V
of
this
document.
However,
the
Agency
is
retaining
the
FQPA
Safety
Factor
(
10X)
for
database
uncertainty
for
lack
of
both
acute
and
subchronic
neurotoxicity
studies.

c.
Toxicological
Endpoints
Triadimefon
Table
3
summarizes
the
studies,
toxicological
endpoints,
dose
levels,
and
uncertainty/
safety
factors
selected
for
the
assessment
of
dietary,
oral,
dermal,
and
inhalation
exposure
to
triadimefon.
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.
Therefore,
the
endpoint
of
concern
is
neurotoxicity
and
is
the
same
for
both
triadimefon
and
triadimenol.
14
Table
3.
Summary
of
Doses
and
Toxicological
Endpoints
for
Triadimefon
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Effects
Acute
Dietary
(
general
population)
NOAEL
=
3.4
mg/
kg/
day
(
subchronic)

UF
=
100
Acute
RfD
=
0.034
mg/
kg/
day
FQPA
SF
=
10X
aPAD
=
acute
RfD
FQPA
SF
aPAD
=
0.0034
mg/
kg/
day
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501).
LOAEL
=
54.6
mg/
kg/
day
(
males)
and
68.7
mg/
kg/
day
(
females)
based
largely
on
hyperactivity.

Chronic
Dietary
(
all
populations)
NOAEL
=
3.4
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.034
mg/
kg/
day
FQPA
SF
=
10X
cPAD
=
chronic
RfD
FQPA
SF
cPAD
=
0.0034
mg/
kg/
day
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501).
LOAEL
=
54.6
mg/
kg/
day
(
M)
and
68.7
mg/
kg/
day
(
F)
based
largely
on
hyperactivity.

Incidental
Oral
Short­
Term
(
1
­
30
days)
NOAEL
=
3.4
mg/
kg/
day
UF
=
100
FQPA
SF
=
10X
Residential
MOE
=
1000
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501).
LOAEL
=
54.6
mg/
kg/
day
(
M)
and
68.7
mg/
kg/
day
(
F)
based
largely
on
hyperactivity.

Dermal
Short­
Term
(
1
­
30
days)
and
Intermediate­
Term
(
1
­
6
months)
Dermal
NOAEL
=
300
mg/
kg/
day
UF
=
100
Residential
MOE
=
1000
FQPA
SF
=
10X
Occupational
MOE
=
100
21
day
dermal
toxicity
in
rats
(
MRID
42341501).
The
LOAEL=
1000
mg/
kg/
day
based
on
increased
reactivity
and
activity
in
the
females.

Inhalation
Short­
Term
(
1
­
30
days)
NOAEL
=
3.4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)

UF
=
100
Residential
MOE
=
1000
FQPA
SF
=
10X
Occupational
MOE
=
100
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501).
LOAEL
=
54.6
mg/
kg/
day
(
M)
and
68.7
mg/
kg/
day
(
F)
based
largely
on
hyperactivity.

Inhalation
Intermediate­
Term
(
1
­
6
months)
NOAEL
=
3.4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)

UF
=
100
Residential
MOE
=
1000
FQPA
SF
=
10X
Occupational
MOE
=
100
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501).
LOAEL
=
54.6
mg/
kg/
day
(
M)
and
68.7
mg/
kg/
day
(
F)
based
largely
on
hyperactivity.

Cancer
(
oral,
dermal,
inhalation)
Classification:
Category
C
(
possible
human
carcinogen)
based
on
statistically
significant
increase
in
thyroid
adenomas
in
male
Wistar
rats
and
statistically
significant
increases
in
hepatocellular
adenomas
in
both
sexes
of
the
NMRI
mouse.

UF,
uncertainty
factor;
SF,
safety
factor;
NOAEL,
no
observable
adverse
effect
level;
LOAEL,
lowest
observable
adverse
effect
level;
RfD,
reference
dose,
exposure
which
is
not
expected
to
exceed
EPA's
level
of
concern;
PAD,
population
adjusted
dose,
which
is
the
RfD
adjusted
for
the
FQPA
safety
factor
(
SF);
MOE,
margin
of
exposure;
LOC,
Level
of
Concern,
MOE
at
and
above
which
the
Agency
does
not
have
a
risk
concern.
NA,
Not
Applicable.
15
Triadimenol
Table
4
summarizes
the
studies,
toxicological
endpoints,
dose
levels,
and
uncertainty/
safety
factors
selected
for
the
assessment
of
dietary
exposure
to
triadimenol.
The
endpoint
of
concern
is
neurotoxicity
(
same
as
triadimefon).

Table
4.
Summary
of
Doses
and
Toxicological
Endpoints
for
Triadimenol
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Effects
Acute
Dietary
(
general
population)
NOAEL
=
3.4
mg/
kg/
day
(
subchronic)

UF
=
100
Acute
RfD
=
0.034
mg/
kg/
day
FQPA
SF
=
10X
aPAD
=
acute
RfD
FQPA
SF
aPAD
=
0.0034
mg/
kg/
day
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501)
for
triadimefon.
LOAEL
=
54.6
mg/
kg/
day
(
M)
and
68.7
mg/
kg/
day
(
F)
based
largely
on
hyperactivity.

Chronic
Dietary
(
all
populations)
NOAEL
=
3.4
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.034
mg/
kg/
day
FQPA
SF
=
10X
cPAD
=
chronic
RfD
FQPA
SF
cPAD
=
0.0034
mg/
kg/
day
Subchronic
neurotoxicity
study
in
rats
(
MRID
44153501)
for
triadimefon.
LOAEL
=
54.6
mg/
kg/
day
(
M)
and
68.7
mg/
kg/
day
(
F)
based
largely
on
hyperactivity.

Cancer
(
oral,
dermal,
inhalation)
Classification:
Category
C
"
possible
human
carcinogen"
based
on
increased
incidence
of
hepatocellular
adenomas
in
females.

2.
Carcinogenicity
Triadimefon
The
Cancer
Assessment
Review
Committee
(
CARC)
assigned
triadimefon
a
classification
of
"
possible
human
carcinogen",
using
the
criteria
in
the
Draft
Guidelines
for
Carcinogen
Risk
Assessment
(
July,
1999).
This
classification
is
based
on
a
statistically
significant
increase
in
thyroid
adenomas
in
male
Wistar
rats
and
statistically
significant
increases
in
hepatocellular
adenomas
in
both
sexes
of
the
NMRI
mouse.
However,
the
Agency
concluded
that
a
quantified
carcinogenic
risk
assessment
for
triadimefon
is
not
appropriate
and
risk
assessment
will
be
based
on
the
chronic
population
adjusted
dose
(
cPAD)
and
margin
of
exposure
(
MOE)
approaches
only.

Triadimenol
The
CARC
has
assigned
triadimenol
a
classification
of
"
possible
human
carcinogen",
using
the
criteria
in
the
Draft
Guidelines
for
Carcinogen
Risk
Assessment
(
July,
1999).
This
classification
is
based
on
increased
incidence
of
hepatocellular
adenomas
in
females.
However,
the
Agency
concluded
that
a
quantified
carcinogenic
risk
assessment
for
triadimenol
is
not
appropriate
and
risk
assessment
will
be
based
on
the
chronic
population
adjusted
dose
(
cPAD)
and
margin
of
exposure
(
MOE)
approaches
only.
16
3.
Endocrine
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

Triadimefon
and
Triadimenol
The
toxicity
databases
for
triadimefon
and
triadimenol
did
not
show
any
estrogen,
androgen,
or
thyroid
mediated
toxicity.

4.
Dietary
Exposure
and
Risk
The
registrant
has
agreed
to
voluntarily
cancel
all
food
(
apples,
pears,
grapes,
and
raspberries),
except
pineapple,
and
residential
turf
use
for
triadimefon1.
Thus,
these
uses
were
not
included
in
this
dietary
risk
assessment.
In
addition,
the
registrant
is
only
supporting
a
maximum
turf
rate
of
2
applications
of
2.7
lbs.
ai/
A
for
golf
courses
and
sod
farms.
Therefore,
all
drinking
water
risk
estimates
were
calculated
using
this
rate.

Dietary
risk
assessments
consider
exposure
to
pesticide
residues
from
both
food
and
drinking
water.
In
examining
dietary
risk,
exposures
from
the
use
of
triadimefon,
which
includes
the
parent
and
its
metabolites,
including
triadimenol,
as
well
as
exposures
from
the
use
of
triadimenol,
which
includes
the
parent
and
its
metabolites,
must
be
added
together.
This
is
due
to
the
fact
that
both
the
acute
and
chronic
PADs
are
based
on
the
same
study
(
a
subchronic
neurotoxicity
study
in
rats
exposed
to
triadimefon)
and
therefore
must
be
aggregated.
To
estimate
dietary
risks
from
food
and
drinking
water,
EPA
compares
the
estimated
exposure
to
pesticide
residues
in
food
and
drinking
water
to
the
acute
or
chronic
population
adjusted
dose,
or
PAD.
The
PAD
is
the
reference
dose
(
RfD)
adjusted
for
the
FQPA
safety
factor.
A
risk
estimate
that
is
less
than
100%
of
the
acute
PAD
(
aPAD),
the
dose
at
which
an
individual
could
be
exposed
over
the
course
of
a
single
day
and
no
adverse
health
effects
would
be
expected,
does
not
exceed
EPA's
level
of
concern.
Likewise,
a
risk
estimate
that
is
less
than
100%
of
the
chronic
PAD
(
cPAD),
the
dose
at
which
an
individual
could
be
exposed
over
the
course
of
a
lifetime
and
no
adverse
health
effects
would
be
expected,
does
not
exceed
EPA's
level
of
concern.
Additional
details
about
the
dietary
risk
1
Bayer
no
longer
wishes
to
support
these
uses.
The
Agency
will
take
regulatory
action
under
FFDCA
to
revoke
the
associated
tolerances.
17
assessment
for
triadimefon
and
triadimenol
are
described
in
the
July
6,
2006,
document,
Triadimefon.
Revised
Acute
and
Chronic
Dietary
(
Food
+
Drinking
Water)
Exposure
and
Risk
Assessments
for
the
Triadimefon
Reregistration
and
in
the
February
9,
2006,
document,
Triadimenol:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
(
Revised).

Acute
PAD.
As
discussed
in
Section
III
of
this
document,
the
Agency
used
the
subchronic
neurotoxicity
study
(
SCN)
for
triadimefon
to
establish
the
acute
RfD
that
is
used
for
both
chemicals.
The
endpoint
of
concern
is
neurotoxicity
seen
after
both
an
acute
gavage
and
repeated
dietary
exposure.
The
NOAEL
was
3.4
mg/
kg/
day.
The
aPAD
is
0.0034
mg/
kg/
day.
Dietary
risk
results
>
100%
of
the
aPAD
are
above
the
Agency's
level
of
concern.
Refer
to
Table
3
above.

Chronic
PAD.
Combined
dietary
risk
for
triadimefon
and
triadimenol
was
assessed
by
comparing
chronic
dietary
exposure
estimates
(
in
mg/
kg/
day)
to
the
triadimefon
cPAD.
Dietary
risk
is
expressed
as
a
percent
of
the
cPAD,
which
is
the
chronic
RfD
(
3.4
mg/
kg/
day­
NOAEL)
modified
by
an
uncertainty
factor
of
1000
(
10X
for
inter­
species
extrapolation,
10X
for
intra­
species
variability,
and
10X
FQPA
safety
factor
for
database
uncertainty­
lack
of
a
developmental
neurotoxicity
study).
Therefore,
the
cPAD
for
triadimefon
and
triadimenol
is
0.0034
mg/
kg/
day.
Dietary
risk
results
>
100%
of
the
cPAD
are
above
the
Agency's
level
of
concern.
The
cPAD
was
derived
from
a
subchronic
neurotoxicity
study
in
rats,
which
accounted
for
the
most
sensitive
species
and
endpoints
(
rat
versus
chronic
dog
study),
with
a
LOAEL
of
54.6
(
male)
and
68.7
(
female)
mg/
kg/
day
as
noted
in
Table
3
above.

a.
Dietary
(
Food)
Risk
Assessment
The
Agency
conducted
acute
and
chronic
dietary
exposure
assessments
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.

1)
Acute
Dietary
Food
Risk
A
probabilistic
(
Monte­
Carlo)
acute
dietary
exposure
assessment
was
conducted
based
on
field
trial
data
and
100%
crop
treated
(%
CT)
at
the
95th
percentile.
The
risk
assessment
combined
exposure
for
both
triadimefon
and
triadimenol.
Acute
dietary
(
food
only)
risk
estimates
were
based
on
field
trial
data
for
pineapples
(
triadimefon
and
triadimenol)
and
bananas
(
triadimenol),
plus
seed
treatment
uses
on
cotton
and
grain
(
barley,
corn,
oats,
rye,
sorghum,
and
wheat)
from
triadimenol
based
on
a
tolerance
level
approach
and
assuming
100%
crop
treated.
The
ratio
of
total
toxic
residues
(
TTR)
to
triadimefon,
from
available
metabolism
studies,
was
used
to
estimate
the
total
residues
of
concern.

For
food
alone,
acute
dietary
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
aPAD)
at
the
95th
percentile
exposure
for
children
1­
2
years
old
at
32%
of
the
aPAD,
the
most
highly
exposed
population
subgroup.
The
95th
percentile
of
exposure
is
the
appropriate
percentile
to
use
given
the
level
of
refinement
(
i.
e.,
unrefined)
of
the
residue
values
used
and
that
100%
of
the
crops
are
assumed
to
be
treated.
Refer
to
Table
5
below.
18
Table
5.
Results
of
Acute
Dietary
Exposure
Analysis
for
Food
Alone
Using
DEEMFCID
95th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.0034
0.000520
15
All
Infants
(<
1
year
old)
0.0034
0.000828
24
Children
1­
2
years
old
0.0034
0.001083
32
Children
3­
5
years
old
0.0034
0.000923
27
Children
6­
12
years
old
0.0034
0.000668
20
2)
Chronic
Dietary
Food
Risk
Chronic
dietary
exposure
assessments
were
also
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
risk
assessment
combined
exposure
for
both
triadimefon
and
triadimenol.
Chronic
dietary
(
food
only)
risk
estimates
were
based
on
field
trial
data
for
pineapples
(
triadimefon
and
triadimenol)
and
bananas
(
triadimenol),
plus
seed
treatment
uses
on
cotton
and
grain
(
barley,
corn,
oats,
rye,
sorghum,
and
wheat)
from
triadimenol
using
a
tolerance
level
approach
and
assuming
100%
crop
treated.

For
all
supported
commodities,
the
chronic
dietary
exposure
to
triadimefon
from
food
(
only)
is
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
U.
S.
population
(
6%
cPAD)
and
all
population
subgroups,
including
children
1­
2
years
old
(
15%
of
the
cPAD),
the
most
highly
exposed
subgroup.
Refer
to
Table
6
below.

Table
6.
Results
of
Chronic
Dietary
Exposure
Analysis
for
Food
Alone
Using
DEEMFCID
Food
Alone
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.0034
0.000194
6
All
Infants
(<
1
year
old)
0.0034
0.000227
7
Children
1­
2
years
old
0.0034
0.000493
15
Children
3­
5
years
old
0.0034
0.000471
14
Children
6­
12
years
old
0.0034
0.000323
10
19
b.
Dietary
Exposure
from
Drinking
Water
Surface
Water
Exposure
Triadimefon
and
triadimenol
can
be
transported
to
surface
water
during
or
after
application
via
run­
off
and/
or
erosion
as
well
as
soil
leaching
from
ground
applications.
The
triadimefon
surface
water
assessment
is
based
on
Florida
turf
use.
This
scenario
was
chosen
because
it
is
expected
to
present
the
greatest
risk
to
drinking
water
supplies.
Because
water
monitoring
data
for
triadimefon
are
limited,
the
Agency
used
screening­
level
models
to
estimate
drinking
water
concentrations
of
triadimefon
from
surface
water.

Since
current
labels
do
not
limit
the
number
of
applications,
EECs
were
calculated
for
a
range
of
numbers
of
applications
for
residential
and
golf/
sod
turf.
However,
Bayer,
the
technical
registrant,
is
only
supporting
a
maximum
turf
rate
of
2
applications
of
2.7
lbs.
ai/
A
for
golf
courses
and
sod
farms.
As
a
result,
only
those
results
are
presented
here.
Since
there
is
no
limitation
for
application
to
tees,
greens,
and/
or
fairways,
"
entire
course"
values
(
also
applies
to
sod
farm
use)
were
used
in
determining
potential
surface
drinking
water
concentration(
s).

A
summary
of
the
surface
water
concentration
scenarios
is
presented
below
in
Table
7.
For
additional
information,
refer
to
the
Tier
2
Drinking
Water
Assessment
for
Triadimefon
and
its
Major
Degradate
Triadimenol,
dated
August
31,
2005.

Table
7.
Estimated
Concentrations
of
Triadimefon
and
its
Degradate
Triadimenol
in
Surface
Drinking
Water
Using
PRZM/
EXAMS
Scenarios
(
Turf)
Chronic
Concentration
(
ppb)
Use
Scenario
Portion
of
Golf
Course­
(
Treated)
Acute
Concentration
(
ppb)
1
in
10
year
annual
mean
(
non­
cancer)
(
ppb)
30­
year
overall
mean
(
cancer)
(
ppb)
2
applications
14
day
interval
2.75
lbs
ai/
A
(
1
oz/
1000
ft
2)
Entire
Course
100.8
24.94
4.071
Groundwater
Exposure
As
an
initial
screen,
the
concentrations
expected
in
ground
water
for
the
use
of
triadimefon
were
estimated
using
the
SCI­
GROW
model
(
Tier
1
Ground
Water
Computer
Model).
In
addition,
groundwater
monitoring
studies
were
supplied
by
the
registrant,
Bayer
CropScience.
Although
SciGrow
should
typically
over­
estimate
expected
ground
water
concentrations,
in
this
case
the
model
actually
underestimated
the
SciGrow
predicted
value
in
at
least
one
instance.
A
ground
water
monitoring
study
in
New
Jersey,
which
reflected
suggested
turf
uses,
showed
a
peak
groundwater
concentration
of
25
ppb,
while
the
SciGrow
estimate
for
similar
usage
yielded
an
estimate
of
only
5
ppb.
Therefore,
the
potential
for
ground
water
triadimefon
contamination
may
be
greater
than
supposed.
Although
the
ground
water
monitoring
values
were
lower
than
surface
water
modeled
values,
there
may
be
an
20
unforeseen
risk
to
private
shallow
ground
water
wells
used
for
drinking
water
in
areas
where
triadimefon
is
applied.
This
may
be
further
exacerbated
by
the
fact
that,
unlike
surface
water,
which
is
generally
treated
prior
to
use,
private
well
water
may
be
used
in
the
home
with
no
pre­
treatment.
However,
although
the
Agency
recognizes
the
potential
for
groundwater
contamination,
surface
water
estimates
in
this
case
are
considered
protective
for
ground
and/
or
drinking
water
contributions.
For
more
information
on
drinking
water
risks
and
representative
calculations,
see
the
Water
Exposure/
Risk
Pathway
section
of
the
revised
human
health
risk
assessment,
dated
February
9,
2006.

c.
Dietary
Risk
from
Drinking
Water
Drinking
water
exposure
to
pesticides
can
occur
through
ground
and
surface
water
contamination.
In
assessing
drinking
water
risks,
EPA
considers
acute
(
one­
day)
and
chronic
(
long­
term)
exposure,
and
uses
modeling
and
monitoring
data,
if
available,
to
estimate
those
exposures.
Given
the
limited
use
patterns
of
triadimenol
(
seed
treatment)
and
the
amount
of
pesticide
available
on
a
per
acre
basis,
drinking
water
exposures
resulting
from
the
use
of
triadimefon
in
both
surface
and
ground
water
are
much
greater.
Consequently,
the
Agency
is
using
the
exposure
values
from
the
use
of
triadimefon
in
its
assessments
which
is
protective
of
any
drinking
water
exposure
from
the
use
of
triadimenol.
Estimated
environmental
drinking
water
concentrations
(
EDWCs)
for
triadimefon
were
calculated
using
the
PRZMEXAMS
model.
The
assessment
also
accounted
for
triadimenol
as
the
primary
degradate
in
water.
The
PRZM­
EXAMS
assessment
considers
100%
of
the
golf
course
was
treated
and
that
the
watershed
was
100%
golf
course.
Based
on
these
conservative
assumptions,
the
Agency
is
regulating
at
the
95
percentile.
The
distribution
of
estimated
residues
of
triadimefon
and
triadimenol
were
incorporated
directly
into
the
acute
dietary
assessment.

Triadimefon
transforms
into
triadimenol
in
the
natural
environment,
particularly
in
shallow
subsurface
soil
and
is
moderately
mobile
and
persistent.
Triadimefon
on
or
near
the
soil
surface
or
on
vegetation
may
be
subject
to
runoff
and/
or
erosion
into
surface
water
bodies
used
as
drinking
water
supplies.
Triadimefon
and
triadimenol
may
also
leach
into
groundwater
when
triadimefon
is
applied
in
areas
with
well­
drained
soil,
high
rainfall
(
and/
or
irrigation)
rates,
and
shallow
water
tables.
Once
it
reaches
groundwater,
triadimenol
is
likely
to
degrade
more
slowly
than
the
parent
compound.
Both
parent
and
degradate
are
stable
to
hydrolysis
and
have
fairly
long
half­
lives
in
soil
and
water.
The
Agency
modeled
surface
drinking
water
values
which
are
higher
than
groundwater
estimates,
and
are
therefore
protective
for
dietary
risk
analyses.

1)
Acute
Dietary
Water
Risk
The
Agency
believes
it
is
appropriate
to
use
the
95th
percentile
as
the
level
of
concern
(
LOC)
for
drinking
water
because
the
drinking
water
assessment
is
conservative.
The
following
factors
provide
the
rationale
for
this
approach:
1)
the
Agency
assumes
that
100
percent
of
the
watershed
is
in
golf
courses
(
100
percent
cropped
area
(
PCA)),
and
therefore
100%
of
the
watershed
is
turf
treated
with
triadimefon;
2)
residue
estimates
were
modeled
using
PRZM­
EXAMS,
which
usually
results
in
higher
water
concentration
values
than
would
monitoring
data;
3)
the
dose
spacing
between
the
NOAEL
and
LOAEL
in
the
21
guideline
acute
and
subchronic
neurotoxicity
studies
is
fairly
large;
and
4)
the
entire
golf
course
is
assumed
to
be
treated.

Acute
dietary
(
water
only)
risk
estimates
were
based
on
a
FL
golf
course
scenario
for
triadimefon.
The
acute
dietary
exposure
to
triadimefon
from
water
(
only)
is
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
U.
S.
population
(
24%
aPAD)
and
all
population
subgroups,
including
all
infants
(<
1
year
old)
(
85%
of
the
aPAD),
the
most
highly
exposed
subgroup
(
See
Table
8).

Table
8.
Results
of
Acute
Dietary
Exposure
Analysis
for
Water
(
only)
Using
DEEMFCID
95th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.0034
0.000812
24
All
Infants
(<
1
year
old)
0.0034
0.002904
85
Children
1­
2
years
old
0.0034
0.001235
36
Children
3­
5
years
old
0.0034
0.001148
34
Children
6­
12
years
old
0.0034
0.000789
23
2)
Chronic
Dietary
Water
Risk
Chronic
dietary
(
water
only)
risk
estimates
were
based
on
this
scenario
incorporating
both
triadimefon
and
its
degradate
triadimenol
to
determine
risk
values.
The
chronic
dietary
exposure
to
triadimefon
from
water
(
only)
is
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
U.
S.
population
(
12%
cPAD)
and
all
population
subgroups,
including
non­
nursing
infants
(
49%
of
the
cPAD),
the
most
highly
exposed
subgroup
(
See
Table
9).

Table
9.
Results
of
Chronic
Dietary
Exposure
Analysis
for
Water
(
only)
Using
DEEMFCID
95th
Percentile
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.0034
0.000414
12
Infants
(
non­
nursing)
0.0034
0.001681
49
Children
1­
2
years
old
0.0034
0.000615
18
Children
3­
5
years
old
0.0034
0.000575
17
Children
6­
12
years
old
0.0034
0.000397
12
22
5.
Residential
(
Non­
dietary)
Exposure
and
Risk
Triadimefon
The
registrant
has
agreed
to
voluntarily
delete
residential
turf
use
based
on
exposure
to
toddlers.

Triadimenol
There
are
no
residential
uses
of
triadimenol
products.

Currently,
triadimefon
products
are
marketed
for
homeowner
use
on
residential
lawns,
landscape
ornamentals,
and
trees.
Triadimefon­
containing
products
are
also
marketed
for
use
by
professional
applicators
(
Pest
Control
Operators,
or
PCOs)
on
residential
turf,
on
golf
courses,
other
turf
such
as
recreational/
commercial
areas,
and
on
ornamental
plantings.
Based
on
these
uses,
triadimefon
is
assessed
for
the
residential
handler,
and
for
postapplication
dermal
contact
for
adults,
youths,
and
for
toddler's
post­
application
incidental
oral
exposure
that
may
occur
from
turf
contact.
Residential
exposure
may
occur
during
and
after
application
at
homes,
or
after
applications
at
golf
courses,
parks,
schools,
or
other
turf
sites.
Each
route
of
exposure
(
oral,
dermal,
inhalation)
is
assessed,
where
appropriate,
and
risk
is
expressed
as
a
Margin
of
Exposure
(
MOE
>
1000
does
not
exceed
the
Agency's
Level
of
Concern).
For
more
information
on
residential
exposure
and
risk,
refer
to
the
document,
Triadimefon:
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document,
dated
June
30,
2006.

a.
Residential
Handler
Risk
The
anticipated
use
patterns
and
current
labeling
indicate
several
residential
handler
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
be
used
to
make
triadimefon
applications.
The
quantitative
short­
term
exposure/
risk
assessment
developed
for
residential
handlers
is
based
on
these
scenarios.
Intermediate­
or
long­
term
exposures
are
not
likely
because
of
the
intermittent
nature
of
applications
by
homeowners.

(
Mixer/
Loader/
Applicators):

(
1)
Liquid
Formulations:
Low
Pressure
Handwand
(
ORETF
data
for
ornamentals)
(
2)
Wettable
Powder
Formulations:
Low
Pressure
Handwand
(
PHED
data)
(
3)
Liquid
Concentrates
with
Hose­
End
Sprayer
(
Residential
ORETF
data
­­
ornamental
shrubs)
(
4)
Wettable
Powders
with
Hose­
End
Sprayer
(
Residential
ORETF
data
­­
liquid
concentrate
application
to
ornamentals)
(
5)
Liquid
Concentrates
with
a
Tree
Injector
(
no
data)
(
6)
Loading/
Applying
Granulars
via
Push
Type
Spreader
(
ORETF
data)
(
7)
Loading/
Applying
Granulars
via
Belly
Grinder
(
PHED
data)
23
Inhalation
risks
for
residential
handlers
are
not
a
concern
for
all
residential
uses
of
triadimefon.
Combined
dermal
and
inhalation
risks
for
residential
handlers
are
not
a
concern
(
MOEs
>
1000)
for
the
following
scenarios:

(
1)
Mixing/
loading/
applying
liquid
and
wettable
powder
formulations
to
outdoor
and
greenhouse
flowers,
trees,
and
shrubs
with
a
low
pressure
handwand;
(
2)
Loading/
applying
granulars
via
push
type
spreader
and
belly
grinder.

However,
combined
risks
remain
a
concern
(
MOEs
<
1000)
for
mixing/
loading/
applying
liquid
concentrates/
wettable
powders
with
a
hose­
end
sprayer
to
greenhouse
ornamentals.
Short­
term
risks
for
residential
handlers
are
presented
below
in
Table
10,
which
only
represents
those
scenarios
that
exceed
the
Agency's
level
of
concern
(
MOE
<
1000).

Table
10.
Triadimefon
Residential
Handler
Risks
Baseline
Unit
Exposure
MOEs
Exposure
Scenario
Crop
or
Target
App
Ratea
(
lb
ai
/
gallon)
Area
Treated
Dailyb
(
gallons)
Dermalc
(
mg/
lb
ai)
Inhalationd
(
mg/
lb
ai)
Baseline
Dermal
Baseline
Inhalation
Baseline
Dermal
+
Baseline
Inhalation
MOE
Mixer/
Loader/
Applicator
Mixing/
Loading/
Applying
Liquid
Concentra
tes
with
Hose­
End
Sprayer
Greenhouse
ornamentals
(
shrubs,
trees)
0.00938
100
39
1.6
490
160000
490
Mixing/
Loading/
Applying
Liquid
Concentra
tes
with
Hose­
End
Sprayer
Greenhouse
ornamentals
(
flowering)
0.00938
100
34
0.82
560
310000
560
Mixing/
Loading/
Applying
Wettable
Powders
with
Hose­
End
Sprayer
Greenhouse
ornamentals
(
flowering)
0.00625
100
34
0.82
850
460000
850
24
Baseline
Unit
Exposure
MOEs
Exposure
Scenario
Crop
or
Target
App
Ratea
(
lb
ai
/
gallon)
Area
Treated
Dailyb
(
gallons)
Dermalc
(
mg/
lb
ai)
Inhalationd
(
mg/
lb
ai)
Baseline
Dermal
Baseline
Inhalation
Baseline
Dermal
+
Baseline
Inhalation
MOE
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
triadimefon.
b
Amount
handled
per
day
values
are
EPA
estimates
of
acres,
square
feet,
or
cubic
feet
treated
or
gallons
applied
based
on
Exposure
SAC,
SOP
#
9
Standard
Values
for
Daily
Acres
Treated
in
Agriculture,
and
industry
sources,
and
EPA
estimates.
c
Baseline
Dermal:
Long­
sleeve
shirt,
long
pants,
no
gloves.
d
Baseline
Inhalation:
no
respirator.

b.
Residential
Post­
application
Exposure
and
Risks
The
Agency
uses
the
term
"
post­
application"
to
describe
exposures
to
individuals
that
occur
as
a
result
of
being
in
an
environment
that
has
been
previously
treated
with
a
pesticide.
Triadimefon
can
be
used
in
many
areas
that
can
be
frequented
by
the
general
population
including
residential
areas
(
e.
g.,
home
lawns
and
gardens).
As
a
result,
individuals
can
be
exposed
by
entering
these
areas
if
they
have
been
previously
treated.

Exposures
were
calculated
by
considering
the
potential
sources
of
exposure
(
e.
g.,
dislodgeable
foliar
residues
(
DFRs)
on
ornamental
plants)
for
both
triadimefon
and
triadimenol,
then
calculating
dermal
and
non­
dietary
ingestion
exposures
and
risks.
Individuals
of
varying
ages
can
potentially
be
exposed
to
triadimefon
when
they
are
in
areas
that
have
been
previously
treated.
Post­
application
exposure
scenarios
were
developed
for
each
residential
setting
where
triadimefon
can
be
used.
The
scenarios
that
were
assessed
are
dermal
exposure
to
adults,
dermal
exposure
to
youths,
and
dermal
and
incidental
oral
exposure
to
toddlers
from
those
uses
which
remain
where
there
is
a
potential
for
postapplication
exposure.

Risk
Summary:

Risks
were
calculated
using
the
Margin
of
Exposure
(
MOE)
approach,
which
is
a
ratio
of
the
body
burden
to
the
toxicological
endpoint
of
concern.
Risks
to
adults
and
youths
are
below
the
Agency's
level
of
concern
(
See
Table
11
&
12
below).
25
Table
11.
Adult
Residential
Risk
Estimates
for
Post­
application
Exposure
to
Triadimefon
(
including
Triadimenol)

Exposure
Scenario
Route
of
Exposure
Formulation
Application
Rate
(
lb
ai/
acre)
MOE
at
Day
0
Outdoors
 
with
default
transferable
residues
Home
Garden
(
Ornamentals)
Dermal
Spray
0.25
4,800
Golfer
Dermal
Spray/
Granular
1.3
(
Bayer
max
residential)
12,000
Table
12.
Youth
Residential
Risk
Estimates
for
Post­
application
Exposure
to
Triadimefon
(
including
Triadimenol)

Exposure
Scenario
Route
of
Exposure
Formulation
Application
Rate
(
lb
ai/
acre)
MOE
at
Day
0
Outdoors
 
with
default
transferable
residues
Home
Garden
(
Ornamentals)
Dermal
Spray/
Granular
0.25
13,000
Golfer
Dermal
Spray/
Granular
1.3
(
Bayer
max
residential)
7,800
The
registrant
has
agreed
to
voluntarily
cancel
all
residential
turf
use
and
include
a
pre­
transplant
interval
of
17
days
to
sod
farms
in
order
to
address
any
potential
concerns
for
post­
application
exposure
to
toddlers.

Additional
details
regarding
the
residential
exposure
and
risk
assessments
for
triadimefon
may
be
found
in
the
following
documents:
Triadimefon.
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document,
dated
June
30,
2006.

6.
Aggregate
Exposure/
Risk
from
Triadimefon
and
Triadimenol
The
FQPA
amendments
to
the
FFDCA,
section
408(
b)(
2)(
A)(
ii))
require
the
Agency
to
determine
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
is
reliable
information."
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non
26
occupational
sources
of
exposure.
When
aggregating
exposure
and
risk
from
various
sources,
the
Agency
considers
the
route
and
duration
of
exposure.

Acute
(
Food
and
Water)

The
Agency
believes
it
is
appropriate
to
use
the
95th
percentile
as
the
level
of
concern
(
LOC)
for
the
entire
golf
course
because
it
is
a
highly
conservative
approach.
The
following
factors
provide
the
rationale
for
this
approach:
1)
the
Agency
assumes
that
100
percent
of
the
watershed
is
in
golf
courses
(
100
percent
cropped
area
(
PCA)),
and
therefore
100%
of
the
watershed
is
turf
treated
with
triadimefon;
2)
residue
estimates
were
modeled
using
PRZM­
EXAMS,
which
usually
results
in
higher
water
concentration
values
than
would
monitoring
data;
3)
the
dose
spacing
between
the
NOAEL
and
LOAEL
in
the
guideline
acute
and
subchronic
neurotoxicity
studies
for
triadimefon
are
fairly
large;
and
4)
the
Agency
assumes
that
the
entire
golf
course
is
treated.

Combined
acute
dietary
(
food
and
water)
risk
estimates
from
pineapples
(
triadimefon)
and
drinking
water
(
triadimefon
from
golf
course
application
to
entire
golf
course)
plus
seed
treatment
uses
and
banana
import
tolerance
(
triadimenol)
are
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
is
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.
A
summary
of
acute
dietary
risk
estimates
(
food
+
drinking
water)
is
presented
below
in
Table
13.

Table
13.
Triadimefon
and
Triadimenol
Results
of
Acute
Dietary
Exposure
Analysis
for
Food
+
Drinking
Water
From
the
Golf
Course
(
entire)
Use
Scenario
Using
DEEMFCID
95th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.0034
0.001106
33
All
Infants
(<
1
year
old)
0.0034
0.003190
94
Children
1­
2
years
old
0.0034
0.001959
58
Children
3­
5
years
old
0.0034
0.001765
52
Children
6­
12
years
old
0.0034
0.001210
36
Chronic
(
Food
and
Water)

Combined
chronic
dietary
(
food
and
water)
risk
estimates
were
derived
from
pineapples
and
drinking
water
(
entire
golf
course­
triadimefon)
plus
seed
treatment
uses
and
bananas
import
tolerance
from
triadimenol.
Drinking
water
exposures
are
based
on
using
the
1
in
10
year
annual
mean
concentration
assuming
2
applications
per
year
for
turf
at
2.7
lbs
ai/
A.
The
dietary
exposure
for
chronic
food
and
drinking
water
is
below
the
Agency's
level
of
concern
and
is
18%
of
the
cPAD
for
the
U.
S.
population
and
57%
of
the
cPAD
for
non
27
nursing
infants,
the
most
highly
exposed
population
subgroup.
A
summary
of
chronic
dietary
risk
estimates
(
food
+
drinking
water)
is
presented
below
in
Table
14.

Table
14.
Triadimefon
Results
of
Chronic
Dietary
Exposure
Analysis
for
Food
+
Drinking
Water
From
the
Golf
Course
(
entire)
Using
DEEM­
FCID
95th
Percentile
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.0034
0.000607
18
Infants
(
non­
nursing)
0.0034
0.001952
57
Children
1­
2
years
old
0.0034
0.001108
33
Children
3­
5
years
old
0.0034
0.001047
31
Children
6­
12
years
old
0.0034
0.000720
21
Short­
term
(
Food
+
Water
+
Residential)

The
exposure
attributable
to
residential
uses
of
triadimefon
were
not
initially
aggregated
with
dietary
sources
of
exposure
(
food
plus
drinking
water)
because
at
that
time
the
dietary
and
residential
exposure
pathways
separately
exceeded
the
Agency's
level
of
concern.
The
registrant
agreed
to
voluntarily
delete
residential
turf
uses
and
all
food
uses
(
except
pineapple)
so
that
the
aggregate
risks
are
within
acceptable
levels.
Taking
into
consideration
the
agreement
to
request
deletion
of
these
uses
and
mitigation
requiring
a
17­
day
post­
application,
pre­
transplant
interval
for
sod
farms,
risks
will
be
below
the
Agency's
level
of
concern.

Aggregate
exposures
to
toddlers,
youths,
and
adults
could
occur
from
triadimefon
uses
on
golf
courses
and
in
residential
settings
from
turf
transplanted
from
sod
farms.
The
Agency
assessed
short­
term
aggregate
risks
to
adults
and
toddlers
by
calculating
an
aggregate
risk
MOE
assuming
background
(
chronic)
exposure
to
triadimefon
and
triadimenol
residues
from
dietary
(
food
and
water)
sources.
The
chronic
exposure
from
drinking
water
considers
treatment
of
an
entire
golf
course.
Short­
term
aggregate
risk,
calculated
as
an
MOE,
is
1100
for
toddlers
(
from
the
turf
use),
and
1300
for
adults
and
for
youths
(
from
the
golf
course
use).
None
of
these
estimates
exceed
the
Agency's
level
of
concern.

Aggregate
exposures
could
also
occur
for
adults
making
applications
to
residential
ornamentals.
Using
this
scenario
and
assuming
an
application
rate
of
0.005
to
0.0025
lb.
ai/
gallon
with
the
highest
exposure
scenario
that
is
still
below
the
Agency's
level
of
concern
(
mixing/
loading/
applying
wettable
powders
with
a
low
pressure
handwand
to
greenhouse
ornamentals),
aggregate
(
food
+
water
+
residential)
risk
is
below
the
Agency's
level
of
concern
(
MOE
=
1300).

The
combined
risk
assessment
for
exposures
to
toddlers
following
the
application
of
sod
farm
turf
transplanted
to
a
residential
lawn
are
not
a
concern
(
MOEs
>
1000)
at
day
17
following
application
to
sod
farms
at
the
2.7
lbs
ai/
A
rate.
Therefore,
the
labels
for
these
28
products
must
be
restricted
to
not
allow
transplantation
earlier
than
the
17th
day
after
treatment.

Intermediate­
term
and
Chronic
(
Food
+
Water
+
Residential)

Intermediate­
term
and
chronic
residential
exposures
to
triadimefon
are
not
expected
because
of
the
intermittent
nature
of
applications
in
residential
settings.
Therefore,
intermediate­
term
chronic
aggregate
risk
assessments
were
not
conducted.

7.
Pesticide
and
Pharmaceutical
Co­
Exposure
Assessment
for
The
Triazole
Metabolites
FFDCA
Section
408
requires
EPA
to
consider
potential
sources
of
exposure
to
a
pesticide
and
related
substances
in
addition
to
the
dietary
sources
expected
to
result
from
a
pesticide
use
subject
to
a
tolerance
(
legal
limit
for
pesticide
residue
levels)
in
food
or
feed
commodities.
In
determining
whether
to
maintain
a
pesticide
tolerance,
EPA
must
"
determine
that
there
is
a
reasonable
certainty
of
no
harm "
in
accordance
with
FFDCA,
Section
408(
b)(
2)(
A)(
ii).
The
FDA
regulates
human
drugs
for
safety
and
effectiveness
under
FFDCA
section
505
and
may
approve
use
of
a
drug
in
humans
notwithstanding
the
possibility
that
some
individual
patients
may
experience
adverse
side
effects.
EPA
does
not
believe
that,
for
purposes
of
the
section
408
dietary
risk
assessment,
it
is
compelled
to
treat
a
pharmaceutical
patient
the
same
as
a
non­
patient,
or
to
assume
that
combined
exposures
to
pesticide
and
pharmaceutical
residues
that
lead
to
a
physiological
effect
in
the
patient
constitutes
"
harm"
under
the
meaning
of
section
408
of
the
FFDCA.

Rather,
EPA
believes
that
an
appropriate
way
to
consider
the
metabolite
1,2,4­
triazole
resulting
from
pharmaceutical
use
of
triazole­
derivative
drugs
would
be
to
consider
the
additional
contribution
that
non­
occupational
pesticide
exposure
would
have
to
a
pharmaceutical
patient
exposed
to
the
same
compound.
Where
the
additional
pesticide
exposure
has
no
more
than
a
minimal
impact
on
the
pharmaceutical
patient,
EPA
can
make
a
"
reasonable
certainty
of
no
harm"
finding
for
the
pesticide
tolerances
of
that
compound
under
FFDCA
Section
408.
If
the
potential
impact
on
the
pharmaceutical
user
as
a
result
of
co­
exposure
from
pesticide
use
is
more
than
minimal,
then
EPA
would
not
be
able
to
conclude
that
dietary
residues
were
safe,
and
would
need
to
discuss
with
FDA
appropriate
measures
to
reduce
exposure
from
one
or
both
sources.

As
previously
mentioned,
triadimefon
may
share
a
common
metabolite,
1,2,4­
triazole,
with
triazole­
derivative
pharmaceutical
compounds.
Thus,
EPA
consulted
with
FDA
on
triazole
drugs
that
could
metabolize
to
1,2,4­
triazole
and
the
Agencies
concluded
that
only
one
compound,
anastrozole,
a
chemotherapy
drug
used
to
treat
breast
cancer,
had
this
metabolic
pathway
in
humans.
Because
anastrozole
is
used
at
very
small
doses
in
a
limited
population
of
patients,
EPA
conducted
a
conservative
screening­
level
assessment
to
determine
whether
the
combined
metabolites
from
triazole
pesticide
uses
and
anastrozole
would
adversely
impact
pharmaceutical
users.
EPA
concluded
that,
using
upper­
bound
estimates
for
metabolites
of
anastrozole,
the
combined
metabolite
exposure
is
below
the
Agency's
level
of
concern.
Because
EPA
is
able
to
reach
this
conclusion
with
a
screeninglevel
assessment,
the
Agency
has
not
conducted
a
more
refined
co­
exposure
assessment
for
29
pharmaceutical
uses
as
described
above.
Therefore,
EPA
concludes
that
the
potential
dietary
pesticide
exposure
to
triazole
pesticide
residues
in
food
and
water
will
result
in
no
harm
to
a
patient
being
treated
with
anastrozole.
Please
see
the
May
19,
2006,
memo
from
FDA
and
the
July
18,
2006,
EPA
document
summarizing
EPA
and
FDA
discussions
on
potential
free
triazole
metabolites
of
triazole
derivative
drugs,
(
both
available
in
the
public
docket
for
triadimefon,
EPA­
HQ­
OPP­
2005­
0258)
for
additional
information.

8.
Cumulative
Risk
Assessment
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
Other
substances
are
considered
to
account
for
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
each
individual
substance.
For
the
purposes
of
this
reregistration
eligibility
decision,
EPA
has
concluded
that
triadimefon
and
triadimenol
do
not
share
a
common
mechanism
of
toxicity
with
other
substances.
The
Agency
reached
this
conclusion
after
a
thorough
internal
review
and
external
review
of
the
data
supporting
a
common
mechanism
of
toxicity
for
a
number
of
chemical
classes.
Triadimefon,
triadimenol,
and
the
other
triazole
fungicides
share
the
common
metabolites
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid,
which
are
considered
in
this
RED.

9.
Occupational
Risk
The
registrant
has
agreed
to
voluntarily
delete
all
uses
on
apples,
pears,
grapes,
raspberries,
and
residential
turf.
Occupational
post­
application
exposure
and
risk
assessment
for
agricultural
uses
of
triadimefon
indicates
that
risks
are
not
a
concern
at
day
0
(
i.
e.,
12
hours
after
application)
for
all
use
sites
and
all
post­
application
activities.

Workers
can
be
exposed
to
a
pesticide
through
various
routes/
pathways.
There
is
potential
for
exposure
to
triadimefon
in
occupational
scenarios
from
handling
triadimefon
products
during
the
application
process
(
i.
e.,
mixer/
loaders,
applicators,
flaggers,
and
mixer/
loader/
applicators),
and
a
potential
for
post­
application
worker
exposure
from
entering
into
areas
previously
treated
with
triadimefon.
In
addition,
there
is
potential
exposure
to
workers
who
treat
seed
with
triadimefon
in
commercial
and
nursery
settings
and
to
persons
who
plant
treated
seed.
Occupational
risk
for
all
of
these
potentially
exposed
populations
is
measured
by
a
MOE,
which
determines
how
close
the
occupational
exposure
comes
to
a
dose
level
or
NOAEL.

Occupational
risk
is
assessed
for
exposure
at
the
time
of
application
(
termed
"
handler"
exposure)
and
following
application
(
termed
post­
application
exposure).
Application
parameters
are
generally
defined
by
the
physical
nature
of
the
formulation
(
e.
g.,
formula
and
packaging),
by
the
equipment
required
to
deliver
the
chemical
to
the
use
site,
and
by
the
application
rate
required
to
achieve
an
efficacious
dose.
Post­
application
risk
is
assessed
for
activities
such
as
scouting,
irrigating,
pruning,
and
harvesting,
and
is
based
primarily
on
dermal
exposure
estimates.
Note
that
occupational
risk
estimates
are
intended
30
to
represent
pesticide
workers,
and
on
this
basis
assumptions
are
made
concerning
acres
treated
per
day
and
the
seasonal
duration
of
exposure.

Triadimenol
is
only
being
reviewed
for
tolerance
reassessment
purposes.
Currently
registered
uses
do
not
involve
occupational
exposures.
Therefore,
no
worker
risk
assessment
was
completed.

For
more
information
on
the
assumptions
and
calculations
of
potential
risk
of
triadimefon
to
workers,
refer
to
the
documents
entitled:
Triadimefon.
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document,
dated
June
30,
2006;
and
the
memorandum:
Triadimefon/
Triadimenol:
Summary
of
Refinements
and
Revisions
to
the
Human
Health
Risk
Assessment,
dated
July
10,
2006.

a.
Occupational
Toxicity
Table
15
below
provides
a
listing
of
the
toxicological
endpoints
used
in
the
triadimefon
occupational
risk
assessment.

Table
15.
Toxicological
Endpoints
for
the
Triadimefon
Occupational
Risk
Assessment
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Dermal
Short­
Term
(
1
­
30
days)
Dermal
NOAEL
=
300
mg/
kg/
day
UF
=
100
Occupational
MOE
=
100
21
day
dermal
toxicity
in
rabbits.
The
LOAEL=
1000
mg/
kg/
day
based
on
increased
reactivity
and
activity
in
the
females.

Dermal
Intermediate­
Term
(
1
­
6
months)
Dermal
NOAEL
=
300
mg/
kg/
day
UF
=
100
Occupational
MOE
=
100
21
day
dermal
toxicity
in
rabbits.
The
LOAEL=
1000
mg/
kg/
day
based
on
increased
reactivity
and
activity
in
the
females.

Inhalation
Short­
Term
(
1
­
30
days)
NOAEL
=
3.4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)

UF
=
100
Occupational
MOE
=
100
Subchronic
neurotoxicity
study
in
rats.
LOAEL
=
54.6/
68.7
mg/
kg/
day
based
largely
on
hyperactivity.

Inhalation
Intermediate­
Term
(
1
­
6
months)
NOAEL
=
3.4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)

UF
=
100
Occupational
MOE
=
100
Subchronic
neurotoxicity
study
in
rats.
LOAEL
=
54.6/
68.7
mg/
kg/
day
based
largely
on
hyperactivity.

Cancer
(
oral,
dermal,
inhalation)
Classification:
Category
C
(
possible
human
carcinogen)
based
on
statistically
significant
increase
in
thyroid
adenomas
in
male
Wistar
rats
and
statistically
significant
increases
in
hepatocellular
adenomas
in
both
sexes
of
the
NMRI
mouse.
31
b.
Occupational
Handler
Exposure
Occupational
handler
risk
estimates
have
been
assessed
for
both
short­
and
intermediate­
term
exposure
durations.
Due
to
the
use
patterns
for
triadimefon,
long­
term
exposures
are
not
expected.
Since
the
endpoints
and
points
of
departure
(
PODs)
are
identical
to
assess
short
and
intermediate
exposure,
these
risk
estimates
represent
both
durations
of
exposure.

Occupational
handler
assessments
are
conducted
using
increasing
levels
of
protection.
The
Agency
typically
evaluates
all
exposures
with
minimal
protection
and
then
considers
additional
protective
measures
using
a
tiered
approach
in
an
attempt
to
obtain
an
adequate
MOE.
The
lowest
tier
is
represented
by
the
baseline
clothing
scenario
(
i.
e.,
single
layer
clothing,
socks,
and
shoes),
followed
by
increasing
levels
of
risk
mitigation
such
as
personal
protective
equipment
(
PPE)
and
engineering
controls
(
EC).
In
the
case
of
triadimefon,
exposure
to
pesticide
handlers
is
likely
during
the
occupational
use
of
the
pesticide
in
a
variety
of
occupational
environments.
The
anticipated
use
patterns
and
current
labeling
indicate
several
occupational
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
for
triadimefon
applications.
Based
on
the
use
patterns,
twenty­
seven
major
occupational
handler
exposure
scenarios
(
non­
seed
treatment)
were
identified.
In
addition,
six
major
exposure
scenarios
were
identified
for
pine
seed
treatment.
The
following
exposure
scenarios
were
used
to
develop
the
risk
assessment
for
occupational
handlers.

(
Non­
seed
treatment)

Mixer/
Loaders:
(
1a)
Liquid
Formulations
to
support
Aerial
Applications
(
PHED)
(
1b)
Liquid
Formulations
to
support
Groundboom
Applications
(
PHED)
(
1c)
Liquid
Formulations
to
support
LCO
Handgun
Applications
(
PHED)
(
1d)
Liquid
Formulations
to
support
Airblast
Applications
(
PHED)
(
2a)
Wettable
Powders
to
support
Aerial
Applications
(
PHED)
(
2b)
Wettable
Powders
to
support
Chemigation
Applications
(
PHED)
(
2c)
Wettable
Powders
to
support
Groundboom
Applications
(
PHED)
(
2d)
Wettable
Powders
to
support
LCO
Handgun
Applications
(
PHED)
(
2e)
Wettable
Powders
to
support
Airblast
Applications
(
PHED)
(
2f)
Wettable
Powders
to
support
Rights­
of­
Way
Applications
(
PHED)
(
3a)
Water
Dispersible
Granules
to
support
Aerial
Applications
(
PHED)
(
3b)
Water
Dispersible
Granules
to
support
Chemigation
Applications
(
PHED)
(
3c)
Water
Dispersible
Granules
to
support
Groundboom
Applications
(
PHED)
(
3d)
Water
Dispersible
Granules
to
support
LCO
Handgun
Applications
(
PHED)
(
4a)
Loading
Granulars
to
support
Aerial
Applications
(
PHED)
(
4b)
Loading
Granulars
to
support
Tractor
Drawn
Spreader
Applications
(
PHED)

Applicators:
(
5)
Aerial
Spray
Applications
(
PHED)
(
6)
Aerial
Granular
Applications
(
PHED)
(
7)
Groundboom
Spray
Applications
(
PHED)
32
(
8)
Airblast
Spray
Applications
(
PHED)
(
9)
Handgun
Spray
Applications
(
PHED)
(
10)
Rights
of
Way
Spray
Applications
(
PHED)
(
11)
Tractor­
Drawn
Spreader
Granule
Applications
(
PHED)

Flaggers:
(
12)
Flagging
for
Aerial
Spray
Applications
(
PHED)
(
13)
Flagging
for
Aerial
Granular
Applications
(
PHED)

Mixer/
Loader/
Applicators:
(
14)
Liquid
Formulations:
Low
Pressure
Handwand
Sprayer
(
ORETF)
(
15)
Wettable
Powder
Formulations:
Low
Pressure
Handwand
Sprayer
(
PHED)
(
16)
Water
Dispersible
Granules
with
Low
Pressure
Handwand
(
using
ORETF
data
for
liquid
formulations
as
a
surrogate)
(
17)
Liquid
Formulations:
Handgun
Sprayer
(
ORETF)
(
18)
Wettable
Powders
with
a
Handgun
Sprayer
(
ORETF)
(
19)
Water
Soluble
Bags
with
Handgun
Sprayer
(
ORETF)
(
20)
Dry
Flowables
Concentrates
with
a
Handgun
Sprayer
(
ORETF)
(
21)
Liquid
Formulations:
High
Pressure
Sprayer
(
PHED)
(
22)
Water
Dispersible
Granules:
High
Pressure
Handwand
(
PHED:
liquid
concentrates)
(
23)
Wettable
Powders:
High
Pressure
Handwand
(
PHED:
liquid
concentrates)
(
24)
Liquids
with
an
Tree
Injector
(
no
data)
(
25)
RTU:
Briquette
(
no
data)
(
26)
Liquid
Formulations:
Dip
(
no
data)
(
27)
Loading/
Applying
Granulars
via
Push
Type
Spreader
(
ORETF)

(
Pine
seed
treatment)

(
S­
1)
on­
nursery
loading/
applying
with
hopper
or
planter
box
seed
treatment,
(
S­
2)
on­
nursery
loading/
planting
previously
treated
seeds,
(
S­
3)
on­
nursery
loading/
applying
wettable
powders
using
cement
mixer
equipment
(
using
PHED
mixing/
loading
WP
data),
(
S­
4)
on­
nursery
loading/
applying
dry
flowables
using
cement
mixer
equipment
(
using
PHED
mixing/
loading
DF
data),
(
S­
5)
on­
nursery
drying/
raking/
bagging
treated
seed,
(
S­
6)
loading
and
applying
wettable
powder
formulations
with
commercial
seedtreatment
equipment,
(
S­
7)
commercial
sewer
stitching
bags
of
seed,
(
S­
8)
bagging
and
otherwise
handling
treated
seeds
with
commercial
equipment,
and
(
S­
9)
multiple
commercial
seed
treatment
activities.

c.
Occupational
Handler
Risk
Summary
The
Agency
has
determined
that
there
are
potential
exposures
to
individuals
who
mix,
load,
apply,
and
otherwise
handle
triadimefon
during
the
usual
use
patterns
associated
with
the
pesticide's
use.
33
In
all
non­
seed
treatment
scenarios,
combined
dermal
and
inhalation
MOEs
meet
or
exceed
the
level
of
concern
of
100
at
some
level
of
risk
mitigation
(
personal
protective
equipment
or
engineering
controls).
In
the
majority
of
scenarios
where
data
are
available,
combined
dermal
and
inhalation
risks
are
not
a
concern
at
baseline
(
long­
sleeve
shirt,
long
pants,
shoes,
socks,
no
respirator)
or
baseline
plus
chemical­
resistant
gloves.
However,
there
are
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
(
See
Table
16).

In
all
the
in­
nursery
seed
treatment
scenarios
where
data
are
available,
combined
dermal
and
inhalation
MOEs
meet
or
exceed
the
required
level
of
concern
of
100
at
baseline
or
baseline
plus
chemical­
resistant
gloves.
For
commercial
seed
treatment,
combined
dermal
and
inhalation
risks
meet
or
exceed
the
required
MOE
of
100
with
baseline
PPE.
34
Table
16.
Combined
Dermal
plus
Inhalation
Handler
Risks
for
Agricultural
and
Commercial
Uses
Combined
MOEsi
Exposure
Scenario
Crop
or
Target
App
Rate
(
lb
ai/
acre)
a
Area
Treated
Daily
(
acre)
b
Baselinec
Dermal
+
Baseline
Inh
Single
layer
w/

glovesd
Dermal
+

Baseline
Inh
Double
layer
w/

glovese
Dermal
+

Baseline
Inh
Single
layer
w/
gloves
Dermal
+

80%
Rf
Inh
Single
layer
w/

gloves
Dermal
+

90%
Rg
Inh
Double
layer
w/

gloves
Dermal
+

80%
R
Inh
Double
layer
w/

gloves
Dermal
+

90%
R
Inh
Eng
Controlh
Dermal
+
Inh
Mixer/
Loader
Mixing/
Loading
Liquid
Concentrates
for
Injection
ornamentals
(
shade
trees,

woody
shrubs)
0.000026
lb
ai/
inch
of
trunk
inch
of
trunk
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
Christmas
trees
0.25
350
30
60
61
250
turf
(
sod
farm)
2.7
(
except
CA)
350
2.7
5.6
5.6
23
38
24
42
680
Mixing/
Loading
Wettable
Powders
for
Aerial
Applications
pine
seedlings
0.5
350
15
30
30
130
Mixing/
Loading
Wettable
Powders
for
Chemigation
Applications
turf
(
sod
farm)
2.7
(
except
CA)
350
2.7
5.6
5.6
23
38
24
42
680
azaleas
0.005
lb
ai/
gallon
16000
gallons
32
66
67
270
turf
(
sod
farm)
2.7
80
12
24
25
100
Mixing/
Loading
Wettable
Powders
for
Groundboom
Applications
turf
(
golf
course)
2.7
40
24
49
49
200
35
Combined
MOEsi
Exposure
Scenario
Crop
or
Target
App
Rate
(
lb
ai/
acre)
a
Area
Treated
Daily
(
acre)
b
Baselinec
Dermal
+
Baseline
Inh
Single
layer
w/

glovesd
Dermal
+

Baseline
Inh
Double
layer
w/

glovese
Dermal
+

Baseline
Inh
Single
layer
w/
gloves
Dermal
+

80%
Rf
Inh
Single
layer
w/

gloves
Dermal
+

90%
Rg
Inh
Double
layer
w/

gloves
Dermal
+

80%
R
Inh
Double
layer
w/

gloves
Dermal
+

90%
R
Inh
Eng
Controlh
Dermal
+
Inh
Mixing/
Loading
Wettable
Powders
to
Support
Rightsof
way
sprayer
turf
(
golf
course
and
sod
farms)
2.7
80
12
24
25
100
Applicator
Christmas
trees
0.25
350
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
20000
turf
(
sod
farm)
2.7
350
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
1900
Applying
Sprays
via
Aerial
Equipment
pine
seedlings
0.5
350
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
10000
Applying
Granulars
via
Aerial
Equipment
turf
(
sod
farm)
2.6
350
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
200
Mixer/
Loader/
Applicator
turf
(
golf
course,
sod
farms)
2.7
5
No
Data
15
15
53
79
58
92
Not
Feasible
Mixing/
Loading
/
Applying
Wettable
Powders
with
Low
Pressure
Handwand
(
PHED)
pine
seedlings
0.5
5
No
Data
78
81
290
Not
Feasible
36
Combined
MOEsi
Exposure
Scenario
Crop
or
Target
App
Rate
(
lb
ai/
acre)
a
Area
Treated
Daily
(
acre)
b
Baselinec
Dermal
+
Baseline
Inh
Single
layer
w/

glovesd
Dermal
+

Baseline
Inh
Double
layer
w/

glovese
Dermal
+

Baseline
Inh
Single
layer
w/
gloves
Dermal
+

80%
Rf
Inh
Single
layer
w/

gloves
Dermal
+

90%
Rg
Inh
Double
layer
w/

gloves
Dermal
+

80%
R
Inh
Double
layer
w/

gloves
Dermal
+

90%
R
Inh
Eng
Controlh
Dermal
+
Inh
Mixing/
Loading
/
Applying
Liquids
with
an
Injector
ornamentals
(
shade
trees,

woody
shrubs)
0.000075
lb
ai/
1
inch
of
trunk
circumfere
nce
inch
of
trunk
circumfe
rence
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
Not
Feasible
Mixing/
Loading
/
Applying
RTU
Briquette
pine
seedlings
0.00019
lb
ai/
seedling
seedlings
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
Not
Feasible
pine
seed
(
nurseries)
0.0000625
lb
ai/
gallon
100
gallons
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
Mixing/
Loading
/
Applying
Dip
pineapple
(
post­
harvest)
0.0028
lb
ai/
gallon
100
gallons
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
triadimefon.

b
Amount
handled
per
day
values
are
HED
estimates
of
acres
treated
per
day
based
on
Exposure
SAC
SOP
#
9
"
Standard
Values
for
Daily
Acres
Treated
in
Agriculture,"
industry
sources,
and
HED
estimates.

c
Baseline
=
No
gloves
and
no
respirator
(
i.
e.,
long
sleeve
shirt,
long
pants,
shoes
and
socks.

d
Single
layer
w/
gloves
is
baseline
attire
plus
chemical­
resistant
gloves.

e
Double
layer
w/
gloves
is
coveralls
worn
over
long­
sleeve
shirt
and
long
pants,
plus
chemical­
resistant
gloves
(
with
headgear).

f
80%
Respirator
is
quarter­
face
dust/
mist
respirator
(
that
provides
an
80%
protection
factor).

g
90%
Respirator
is
half­
face
dust/
mist
respirator
(
that
provides
a
90%
protection
factor).

h
Engineering
control
is
closed
mixing/
loading
system,
enclosed
cab,
or
enclosed
cockpit.

i
Combined
MOEs
=
1/[(
1/
Dermal
MOE)
+
(/
Inhalation
MOE)]
37
As
noted
above,
there
are
no
available
data
to
assess
the
following:
1)
mixing/
loading/
applying
liquids
with
a
tree
injector
to
ornamental
trees
and
woody
shrubs;
2)
mixing/
loading/
applying
dips
to
pineapples
(
pre­
plant
and
post­
harvest)
and
pine
seed
(
nursery
applications);
3)
drying/
raking/
bagging
treated
pine
seed;
and
4)
ready­
to­
use
(
RTU)
briquette
applications
to
pine
seedlings.
Therefore,
the
Agency
is
requiring
the
use
of
gloves
to
mitigate
potential
dermal
exposure
for
these
uses
described
above.

d.
Occupational
Post­
application
Risk
Summary
Triadimefon
is
currently
labeled
for
use
on
grapes,
turf
(
including
residential,
golf
course
and
sod
farm
turf),
ornamentals,
apples,
pears,
Christmas
trees,
pine
seedlings,
and
raspberries.
Because
of
the
use
pattern,
a
wide
array
of
individuals
can
potentially
be
exposed
by
working
in
areas
that
have
been
previously
treated.
However,
the
registrant
has
agreed
to
voluntarily
delete
all
uses
on
apples,
pears,
grapes,
raspberries,
and
residential
turf.

The
Agency
has
used
the
most
up­
to­
date
information
available
to
complete
the
postapplication
risk
assessment
for
triadimefon.
Several
data
gaps
exist,
such
as
a
lack
of
triadimefon­
specific
post­
application
studies
and
lack
of
transfer
coefficients
for
certain
crop
activities.
However,
the
existing
database
is
adequate
to
assess
post­
application
risk.

Occupational
risks
were
calculated
using
a
MOE,
which
is
a
ratio
of
the
daily
dose
to
the
toxicological
endpoint
of
concern.
Post­
application
risks
diminish
over
time
because
triadimefon
residues
eventually
dissipate
in
the
environment.
Therefore,
risks
were
calculated
over
time
based
on
changing
residue
levels.
Occupational
post­
application
exposure
and
risk
assessment
for
agricultural
uses
of
triadimefon
indicates
that
risks
are
not
a
concern
at
day
0
(
i.
e.,
12
hours
after
application)
for
all
use
sites
and
all
post­
application
activities.
MOEs
for
occupational
post­
application
risk
range
from
220
for
transplanting,
weeding
(
hand),
harvesting
(
hand),
and
harvesting
(
mechanical)
at
the
2.7
lbs.
ai/
A
rate
on
sod
farms
and
golf
course
turf.

10.
Human
Incident
Data
In
evaluating
incidents
to
humans,
the
Agency
reviewed
reports
from
the
National
Poison
Control
Centers
(
PCC),
California
Department
of
Pesticide
Regulation
(
CDPR),
the
Agency's
Office
of
Pesticide
Program's
Incident
Data
System
(
IDS),
the
National
Pesticide
Information
Center
(
NPIC),
the
National
Institute
of
Occupational
Safety
and
Health's
Sentinel
Event
Notification
System
for
Occupational
Risks
(
NIOSH
SENSOR)
for
poisoning
incident
data
on
triadimefon/
triadimenol.

Data
provided
by
the
PCC
reported
nine
incidents
of
occupational
exposure
to
triadimefon
and
46
non­
occupational
exposures
from
1993
through
2003.
Of
the
46
nonoccupational
exposures,
13
occurred
in
children
under
six
years
of
age.
Of
the
total
20
cases
with
medically
determined
outcome,
11
reported
minor
medical
outcome.
From
a
total
of
55
exposures
to
triadimefon,
just
four
were
seen
in
a
health
care
facility
and
none
required
hospitalization.
A
review
of
symptoms
revealed
almost
exclusively
irritation
effects
(
including
rash
and
erythema)
to
skin,
mouth,
throat,
and
eyes.
In
addition,
there
were
four
38
cases
reporting
headache
and
two
reported
cough.
No
other
significant
symptoms
were
reported.

The
majority
of
triadimefon
incidents
(
92%)
reported
by
CDPR
occurred
prior
to
1990.
Most
of
the
triadimefon
cases
(
73%)
involved
use
on
grapes
which
is
a
labor
intensive
crop
involving
high
exposure
to
foliar
residues.
Foliar
residues
accounted
for
half
of
the
illnesses
and
nearly
half
of
the
systemic
illnesses.
Skin,
eye
irritation,
and
rash
were
among
the
most
common
topical
symptoms.
The
most
common
systemic
effects
included
nausea,
headache,
sneezing,
congestion,
difficulty
breathing
and
other
allergic­
type
reactions.
In
addition,
there
were
three
reports
of
vomiting.
Furthermore,
the
registrant
has
voluntarily
agreed
to
delete
all
food
(
apples,
grapes,
pears,
and
raspberries)
uses.

Reports
submitted
to
the
IDS
indicate
incidents
from
various
sources.
The
NPIC
is
a
toll­
free
information
service
supported
by
OPP.
A
ranking
of
the
top
200
active
ingredients
for
which
telephone
calls
were
received
during
calendar
years
1984­
1991,
inclusive
has
been
prepared.
The
total
number
of
calls
was
tabulated
for
the
categories
human
incidents,
animal
incidents,
calls
for
information,
and
others.
Triadimefon
was
not
reported
on
the
list
of
the
top
200
chemicals
with
incidents
reported
to
NPIC.
Triadimefon
was
associated
with
one
case
out
of
a
total
of
5,899
cases
reported
to
NIOSH
SENSOR
between
1998
and
2003.
However,
this
case
was
a
duplicate
of
a
CDPR
case,
which
had
already
been
reported.

Conclusion:
Both
California
and
Poison
Control
Center
data
show
a
pattern
of
irritative,
but
usually
minor,
symptoms
from
exposure
to
triadimefon.
Irritation
to
skin,
eyes,
and
respiratory
passage
occur
readily
among
unprotected
handlers
(
applicators
and
mixer/
loaders)
and
among
those
who
have
substantial
contact
with
foliage
such
as
grape
harvesters
and
tenders.
Additionally,
it
should
be
noted
that
triadimefon
is
a
skin
sensitizer,
and
as
such,
may
contribute
to
allergic­
type
reactions.
Furthermore,
the
registrant
has
voluntarily
agreed
to
delete
all
uses
on
apples,
grapes,
pears,
and
raspberries.

B.
Environmental
Fate
and
Effects
Risk
Assessment
Triadimefon
has
the
following
registered
uses,
which
result
in
environmental
exposures:
applications
to
fruits
(
apples,
grapes,
pears,
and
raspberries)
turf,
pine
seedlings,
Christmas
trees,
and
ornamentals.
However,
the
registrant
has
agreed
to
voluntarily
delete
all
use
on
apples,
grapes,
pears,
raspberries,
and
residential
turf.
A
summary
of
the
Agency's
environmental
risk
assessment
for
triadimefon
is
presented
below.
More
detailed
information
associated
with
the
environmental
risk
from
the
use
of
triadimefon
can
be
found
in
the
Environmental
Fate
and
Ecological
Risk
Assessment
(
Revised)
for
Triadimefon,
dated
January
19,
2006
and
Response
to
Bayer
Public
Comments
Regarding
the
Environmental
Fate
and
Effects
Division
Triadimefon
Risk
Assessment,
dated
June
1,
2006.
These
documents
may
be
accessed
in
the
OPP
Public
Docket
(
docket
number
EPA­
HQ­
OPP­
2005­
0258)
at
http://
www.
regulations.
gov.
39
1.
Environmental
Fate
and
Transport
Triadimefon
is
stable
to
hydrolysis
but
degrades
by
photolysis
in
water
with
a
halflife
of
7.6
hours.
In
aerobic
sandy
loam
soil,
parent
triadimefon
degraded
with
a
half
life
of
5.6
days,
and
in
anaerobic
sandy
loam
soil
the
half
life
was
23.1
days.
In
anaerobic
aquatic
environments,
triadimefon
had
a
half­
life
of
217
days.
The
primary
degradate
identified
in
environmental
fate
studies
(
aerobic/
anaerobic
soil
and
anaerobic
aquatic)
was
triadimenol.
The
other
degradates
identified
in
these
studies
were:
p­
chlorophenol
(
photolysis
water/
soil),
4­
chlorophenoxy­
1,2,4­
triazol­
1­
yl­
methane
(
aerobic
soil),
and
1H­
1,2,4­
triazole
(
aerobic
soil).

The
environmental
fate
assessment
was
based
on
an
evaluation
of
total
triadimefon
toxic
residues,
which
includes
both
parent
and
the
degradate
triadimenol.
Since
approximately
75%
of
parent
triadimefon
degraded
to
triadimenol
within
60
days
postapplication
for
the
purpose
of
modeling,
physical
characteristics
that
reflected
combined
properties
of
both
compounds
in
proper
relative
proportions
were
used.
Thus,
for
example,
the
aerobic
soil
half­
life
for
total
residues
used
in
modeling
was
240
days.

Both
triadimefon
and
triadimenol
were
shown
to
be
moderately
soluble,
and
are
therefore
capable
of
being
transported
dissolved
in
water
as
surface
runoff
or
as
leachate
to
groundwater.
The
adsorption
coefficients
(
Koc)
for
triadimefon
and
triadimenol
were
387
L/
kgoc
and
365
L/
kgoc
(
average
of
four
soils),
respectively.
Triadimenol
appears
to
be
even
more
prone
to
leaching
than
triadimefon.
This
may
be
due
partly
to
its
formation
in
the
aerobic
subsurface,
where
subsequent
rain
or
irrigation
events
can
leach
it
deeper
into
the
soil.
However,
due
to
its
moderate
mobility
and
adsorption
characteristics,
triadimefon
is
capable
of
persisting
and
accumulating
in
a
variety
of
environmental
conditions.
Therefore,
triadimefon
is
likely
to
be
of
greater
concern
for
surface
water
runoff
issues,
but
triadimenol
is
of
greater
concern
for
groundwater
and
apt
to
be
more
persistent
than
parent
triadimefon
in
most
settings.

2.
Ecological
Exposure
and
Risk
To
estimate
potential
ecological
risk,
EPA
integrates
the
results
of
exposure
and
ecotoxicity
studies
using
the
risk
quotient
method.
Risk
quotients
(
RQs)
are
calculated
by
dividing
estimated
environmental
concentrations
(
EECs),
based
on
environmental
fate
characteristics
and
pesticide
use
data,
by
ecotoxicity
values
for
various
wildlife
and
plant
species.
RQs
are
then
compared
to
levels
of
concern
(
LOCs),
and
when
the
RQ
exceeds
the
level
of
concern
for
a
particular
category,
the
Agency
presumes
a
risk
of
concern
to
that
category.
See
Table
17
for
the
Agency's
LOCs.
Risk
characterization
provides
further
information
on
potential
adverse
effects
and
the
possible
impact
of
those
effects
by
considering
the
fate
of
the
chemical
and
its
degradates
in
the
environment,
organisms
potentially
at
risk,
and
the
nature
of
the
effects
observed.
To
the
extent
feasible,
the
Agency
seeks
to
reduce
environmental
concentrations
in
an
effort
to
reduce
the
potential
for
adverse
effects
to
non­
target
organisms.
40
Table
17.
EPA's
Levels
of
Concern
and
Associated
Risk
Presumptions
Risk
Presumption
LOC
Terrestrial
Animals
LOC
Aquatic
Animals
LOC
Plants
(
Terrestrial/
Aquatic/
Semi­
Aquatic)

Acute
Risk
­
there
is
potential
for
acute
risk.
0.5
0.5
1
Acute
Endangered
Species
­
endangered
species
may
be
adversely
affected.
0.1
0.05
1
Chronic
Risk
­
there
is
potential
for
chronic
risk.
1
1
N/
A
For
a
more
detailed
explanation
of
the
ecological
risks
posed
by
the
use
of
triadimefon,
refer
to
the
"
Environmental
Fate
and
Effects
Division
Revised
Risk
Assessment
for
Triadimefon",
dated
January
19,
2006.

a.
Aquatic
Organism
Exposure
and
Risk
1)
Fish,
Invertebrate,
and
Aquatic
Plant
Toxicity
Freshwater
and
Estuarine/
Marine
Fish
Toxicity
studies
conducted
using
technical
triadimefon
demonstrate
that
it
is
slightly
to
moderately
toxic
to
freshwater
fish
under
acute
exposure
with
LC50
values
ranging
from
4.1
ppm
to
28
ppm
(
rainbow
trout)
and
10
ppm
to
24.7
ppm
(
bluegill
sunfish).
Likewise,
two
freshwater
toxicity
studies
were
also
conducted
for
the
major
triadimefon
degradate,
triadimenol.
The
freshwater
fish
acute
toxicity
values
(
LC50)
for
triadimenol
indicate
that
triadimenol
is
slightly
toxic
on
an
acute
basis.

Tables
18
and
19
summarize
the
data
that
support
the
acute
toxicity
endpoints
used
in
assessing
the
risks
to
freshwater
fish.
No
triadimefon
or
triadimenol
estuarine/
marine
fish
acute
toxicity
tests
were
submitted
to
the
Agency.

Table
18.
Acute
Toxicity
Endpoints
for
Freshwater
Fish
(
Triadimefon)
Test
Species/
%
a.
i.
96­
hr
LC
50
(
ppm)
Toxicity
Classification
MRID
No.
Author/
Year
Cold
water
fish
(
Rainbow
trout,
Oncorhynchus
mykiss
96.8
4.1
Moderately
toxic
43256201
Bowers/
1994
Table
19.
Acute
Toxicity
Endpoints
for
Freshwater
Fish
(
Triadimenol)
Test
Species/
%
a.
i.
96­
hr
LC
50
(
ppm)
Toxicity
Classification
MRID
No.
Author/
Year
Warm
water
fish
(
Bluegill
sunfish,
Lepomis
macrochirus)
92
14
Slightly
toxic
071469
Lamb/
1981
41
For
chronic
toxicity,
a
freshwater
fish
early
life­
stage
test
using
technical
triadimefon
showed
that
the
most
sensitive
species
is
the
rainbow
trout,
with
a
NOAEL
of
41
ppb
(
0.041
ppm).
However,
no
chronic
freshwater
fish
toxicity
data
were
available
for
the
degradate
triadimenol.
In
addition,
no
triadimefon
or
triadimenol
estuarine/
marine
fish
chronic
toxicity
tests
were
submitted.
Table
20
summarizes
the
data
for
the
chronic
toxicity
endpoints
used
in
assessing
the
risks
to
freshwater
fish.

Table
20.
Early
Life­
Stage
Chronic
Toxicity
Endpoints
for
Freshwater
Fish
(
Triadimefon)
Group
(
Test
Species)
%
a.
i.
NOAEL
(
ppm)
LOAEL
(
ppm)
Endpoints
Affected
MRID
No.
Author/
Year
Cold
water
fish
(
Rainbow
trout,
Oncorhynchus
mykiss)
93
0.041
0.116
Growth
251243
Carlisle/
1983
Freshwater
and
Estuarine/
Marine
Invertebrates
Toxicity
studies
conducted
using
technical
triadimefon
demonstrate
that
it
is
slightly
to
moderately
acutely
toxic
to
freshwater
invertebrates,
with
LC50
values
ranging
from
1.6
to
11.3
ppm.
Freshwater
invertebrate
acute
toxicity
tests
were
also
performed
for
the
degradate
triadimenol,
resulting
in
an
LC50
value
of
2.5
ppm
(
moderately
toxic).
Table
21
summarizes
the
data
that
support
the
acute
toxicity
endpoints
used
in
assessing
the
risks
to
aquatic
invertebrates.
No
triadimefon
or
triadimenol
estuarine/
marine
invertebrate
acute
toxicity
tests
were
submitted
to
the
Agency.

Table
21.
Acute
Toxicity
Endpoints
for
Freshwater
Invertebrates
Test
Species/
Flow­
through
%
a.
i.
48­
hr
LC
50
(
ppm)
Toxicity
Classification
MRID
No.
Author/
Year
Triadimefon
Invertebrate
(
Waterflea,
Daphnia
magna)
Tech.
1.6
Moderately
toxic
231311
Lamb/
1997
Triadimenol
Invertebrate
(
Waterflea,
Daphnia
magna)
92
2.5
Moderately
toxic
071469
Lamb/
1981
A
freshwater
early
life
stage
aquatic
toxicity
test
using
technical
triadimefon
is
available
for
daphnia
magna
with
a
NOAEL
of
0.052
ppm
(
decreased
adult
length).
Table
22
summarizes
the
data
for
the
chronic
toxicity
endpoint
used
in
assessing
the
risks
to
freshwater
invertebrates.
No
triadimenol
freshwater
invertebrate
chronic
toxicity
data
was
submitted,
and
no
triadimefon
or
triadimenol
estuarine/
marine
invertebrate
chronic
toxicity
tests
were
submitted.
42
Table
22.
Early
Life­
Stage
Chronic
Toxicity
Endpoints
for
Freshwater
Invertebrates
Group
(
Test
Species)
%
a.
i.
NOAEL
(
ppm)
LOAEL
(
ppm)
Endpoints
Affected
MRID
No.
Author/
Year
Triadimefon
Invertebrate
(
Waterflea,
Daphnia
magna)
94.2
0.052
0.119
Adult
length
41922102
Gagliano/
1991
Non­
target
Aquatic
Plants
An
aquatic
plant
toxicity
study
was
performed
for
triadimefon
on
the
technical
formulated
product
on
green
algae,
resulting
in
an
EC50
value
of
1.71
ppm.
The
EC50
value
for
triadimenol
was
3.7
ppm.
No
studies
were
performed
on
vascular
aquatic
plant
species.
Table
23
summarizes
the
data
for
the
plant
toxicity
endpoints
used
in
assessing
the
risks
to
aquatic
plants.

Table
23.
Toxicity
Endpoints
for
Aquatic
Plants
(
Nonvascular)

Species
%
a.
i.
EC50
(
ppm)
EC05
or
NOAEC
(
ppm)
MRID
No.
Author/
Year
Triadimefon
Green
algae
Scenedesmus
subspicatus
91.5
1.71
0.1
00159558
Heimbach/
1985
Triadimenol
Green
algae
Scenedesmus
subspicatus
94.9
3.7
0.32
266051
Mobay/
1986
2)
Fish
and
Invertebrate
Exposure
This
assessment
assumes
exposure
to
both
the
parent
triadimefon
as
well
as
triadimenol
for
aquatic
organisms.
OPP
generally
uses
computer
simulation
models
to
estimate
exposure
of
aquatic
organisms,
such
as
plants,
fish,
aquatic­
phase
amphibians,
and
invertebrates,
to
a
pesticide.
These
models
calculate
estimated
environmental
concentrations
(
EECs)
in
surface
water
using
laboratory
data
that
describe
the
rate
at
which
the
pesticide
breaks
down
and
how
it
moves
into
the
environment.
The
Pesticide
Root
Zone
Model
and
Exposure
Analysis
Modeling
System
(
PRZM­
EXAMS)
model
is
initially
used
to
calculate
high­
end
estimates
of
surface
water
concentrations
of
pesticide
in
a
generic
pond.
This
model
was
used
to
generate
EECs
of
total
triadimefon
(
parent
+
triadimenol)
in
surface
water.
The
User's
Manual
and
PRZM­
EXAMS
model
description
can
be
consulted
for
additional
information
at:
www.
epa.
gov/
offefed1/
models/
water/
index.
htm.
No
EECs
are
generated
in
instances
where
no
toxicity
was
observed
at
concentrations
above
the
active
ingredient's
water
solubility
or
at
or
above
the
recommended
limit
concentration
for
a
particular
type
of
study.

The
Agency
used
PRZM­
EXAMS
(
Exposure
Analysis
Modeling
System)
modeling
to
derive
tier
II
estimated
environmental
concentrations
(
EECs)
for
triadimefon
in
surface
water.
Unlike
the
drinking
water
assessment
described
in
the
human
health
risk
assessment
section
of
this
document,
the
ecological
water
resource
assessment
does
not
include
the
Index
43
Reservoir
(
IR)
and
Percent­
Crop
Area
(
PCA)
factor
refinements.
The
IR
and
PCA
factors
represent
a
drinking
water
reservoir,
not
the
variety
of
aquatic
habitats,
such
as
ponds
adjacent
to
treated
fields,
relevant
to
a
risk
assessment
for
aquatic
animals.
The
assumptions
used
represent
pesticide
transport
in
surface
water
in
a
standard
pond
(
10,000­
m2
pond,
2­
m
deep),
with
the
assumption
that
the
small
field
(
10­
ha
agricultural
field)
is
cropped
at
100%.
Therefore,
the
EEC
values
used
to
assess
exposure
to
aquatic
organisms
are
not
the
same
as
the
values
used
to
assess
human
dietary
exposure
from
drinking
water
sources.

Several
scenarios
chosen
to
represent
different
U.
S.
regions
and
uses
were
modeled
for
each
use
and
can
be
found
in
the
environmental
fate
and
effects
assessment
for
triadimefon.
The
turf
scenarios
gave
the
maximum
EECs,
and
so
were
chosen
for
regulatory
purposes.
The
EEC
values
used
to
assess
exposure
to
aquatic
organisms
can
be
found
in
the
Environmental
Fate
and
Ecological
Risk
Assessment
(
Revised)
for
Triadimefon,
dated
January
19,
2006.

3)
Fish
and
Invertebrate
Risk
Fish,
Aquatic
Invertebrates,
and
Aquatic
Plants
There
would
be
no
LOC
exceedances
for
fish,
aquatic
invertebrates,
or
aquatic
nonvascular
plants
for
Bayer's
newly
proposed
turf
maximum
application
rate
of
2
applications
of
2.7
lbs.
ai/
A
at
14
day
intervals.
There
were
no
studies
available
to
assess
risk
to
aquatic
vascular
plants
(
See
Table
24).

Table
24.
Aquatic
Organism
RQ
calculations
Acute
Risk
Quotients
Chronic
Risk
Quotients
Crop
App.
rate
(#
of
apps.,
and
interval
between
apps.)
Peak
EEC
(
ppb)
Freshwate
r
Fish
LC50
=
4100
ppb
Freshwater
Invert.
LC50
=
1600
ppb
Aquatic
nonvascular
plants
EC50
=

17000
ppb
60
Day
EEC
21
Day
EEC
Freshwat
er
Fish
NOEAC
=
41
ppb
Freshwater
Invertebrate
NOEAC
=
52
ppb
FL
turf
2.7
lbs.
a.
i./
acre
(
2
app.,
14
day
intervals)
40.65
<
LOC
<
LOC
<
LOC
27.2
33.36
<
LOC
<
LOC
4)
Non­
target
Aquatic
Plants
Risks
were
below
the
Agency's
level
of
concern
for
non­
target
aquatic
non­
vascular
plants.
No
toxicity
data
were
available
to
assess
risks
to
non­
target
aquatic
vascular
plants.
44
b.
Terrestrial
Organism
Exposure
and
Risk
1)
Bird
and
Mammal
Toxicity
Birds
Triadimefon
is
classified
as
practically
non­
toxic
to
birds
with
acute
oral
LD50
values
exceeding
the
highest
dose
tested
(>
4000
mg
ai/
kg
bw)
and
(>
2000
mg
ai/
kg
bw)
via
an
8­
day
and
14­
day
test,
respectively.
With
dietary
LC50
values
between
>
4640
ppm
to
>
10,000
ppm
triadimefon
is
classified
as
practically
non­
toxic
on
a
subacute
dietary
basis.

Avian
single
dose
oral
toxicity
studies
were
also
performed
on
the
major
degradate
triadimenol.
The
acute
oral
(
LD50)
toxicity
of
triadimenol
to
bobwhite
quail
exceeded
the
highest
dose
tested
(>
2000
mg
ai/
kg)
(
MRID
126276).
Additionally,
a
triadimenol
subacute
dietary
study
was
performed
with
mallard
ducks,
and
no
mortality
or
signs
of
toxicity
were
seen
at
any
doses
(
LC50
>
5000
ppm;
MRID
00126277).
The
results
of
both
studies
demonstrate
that
triadimenol
is
practically
nontoxic
to
birds
on
an
acute
oral
and
subacute
dietary
basis.
Table
25
summarizes
the
data
that
support
the
acute
and
subacute
toxicity
endpoints
used
in
assessing
the
risks
to
birds
for
both
triadimefon
and
its
degradate
triadimenol.

Table
25.
Acute
Toxicity
to
Birds
Endpoint
Chemical
Environment/
Species
Toxicity
Value
Used
in
Risk
Assessment
Reference
Toxicity
Classification
Triadimefon
Bobwhite
quail
LD50
=
>
2000
mg
ai/
kg
bw
MRID
41895901
Practically
nontoxic
Acute
Toxicity
to
Birds
Triadimenol
Bobwhite
quail
LD50
=
>
2000
mg
ai/
kg
bw
MRID
071469
Practically
nontoxic
Triadimefon
Bobwhite
quail
LC50
=
8392
ppm
MRID
00050066
Practically
nontoxic
Subacute
Toxicity
to
Birds
Triadimenol
Mallard
duck
LC50
>
5000
ppm
MRID
00126277
Practically
nontoxic
For
chronic
toxicity,
avian
reproduction
toxicity
tests
were
performed
using
technical
triadimefon
resulting
in
a
NOAEL
of
20
ppm
ai
(
bobwhite
quail).
In
addition,
avian
reproduction
toxicity
tests
were
also
performed
for
the
degradate
triadimenol
with
a
NOAEL
of
100
ppm
ai
(
mallard
duck).
Table
26
summarizes
the
data
for
the
chronic
toxicity
endpoints
used
in
assessing
the
risks
to
birds.

Table
26.
Chronic
Toxicity
to
Birds
Species
%
a.
i.
NOAEL
(
ppm
ai)
LOAEL
(
ppm
ai)
LOAEL
Endpoints
MRID
No.
Author/
Year
Triadimefon
Northern
93
20
100
Eggs
cracked,
decrease
in
110430
Lamb/
1982
45
bobwhite
fertile
eggs,
decrease
in
viable
embryos,
hatchling,
14­
day
old
survivors
Triadimenol
Mallard
duck
97
100
500
Eggs
laid,
decrease
in
viability,
hatchability,
14­
day
survivors
40283102
Carlisle/
1984
Mammals
Triadimefon
is
classified
as
slightly
toxic
to
mammals
on
an
acute
basis
with
LD50
values
of
1470
mg/
kg
(
males)
and
1090
mg/
kg
(
females).
Acute
toxicity
tests
showed
LD50
values
of
689
mg/
kg
(
males)
and
752
mg/
kg
(
females)
for
the
degradate
triadimenol,
classifying
it
as
slightly
toxic
to
mammals
(
see
Table
27).

Table
27.
Summary
of
Acute
Toxicity
Endpoints
for
Mammals
Endpoint
Chemical
Species
Toxicity
Used
in
Risk
Assessment
(
Most
sensitive
Endpoints)
Reference:
Classification
Triadimef
on
Rat
LD50
=
1090
mg/
kg
(
females)
MRID
00264276
Acceptable
Acute
Toxicity
to
Mammals
Triadimen
ol
Rat
LD50
=
689
mg/
kg
(
males)
MRID
00125411
Acceptable
Chronic
toxicity
data
for
mammals
from
the
2­
generation
rat
reproduction
study
testing
triadimefon
indicate
decreased
pup
weights
and
viability
in
the
F1
and
F2
generations
and
decreased
litter
size
in
the
F2
generation
with
an
offspring
NOAEL
of
50
ppm
ai.
In
addition,
chronic
toxicity
tests
for
the
degradate
triadimenol
showed
decreased
pup
weights
with
a
NOAEL
of
100
ppm
ai
and
a
LOAEL
of
500
ppm
ai
(
see
Table
28).

Table
28.
Summary
of
Chronic
Toxicity
Endpoints
for
Mammals
Species
Test
Type/
Classification
Toxicity
Values
Used
in
Risk
Assessment
Affected
Endpoints
MRID
No.

Triadimefon
Laboratory
Rat
(
Rattus
norvegicus)
2­
generation
reproduction
Offspring
NOAEL
=
50
ppm
Offspring
LOAEL
=
1800
ppm
Decreased
pup
weight
and
viability.
00155075
92188019
92188320
Triadimenol
Laboratory
Rat
(
Rattus
norvegicus)
2­
generation
reproduction
Parental
NOAEL
=
100
ppm
Parental
LOAEL
=
500
ppm
Offspring
NOAEL
=
Decreased
body
weights
and
weight
gain
Decreased
pup
00151248
46
Species
Test
Type/
Classification
Toxicity
Values
Used
in
Risk
Assessment
Affected
Endpoints
MRID
No.

100
ppm
Offspring
LOAEL
=
500
ppm
weight
2)
Bird
and
Mammal
Exposure
Pesticide
residues
on
food
items
are
estimated
based
on
the
assumption
that
terrestrial
organisms
are
exposed
to
a
single
pesticide
residue
in
a
given
exposure
scenario.
Application
methods
for
liquid
triadimefon
formulations
include
ground
spray,
aerial
spray,
and
chemigation.
Additionally,
granular
triadimefon
is
broadcast
on
residential
lawns
and
turf
(
no
soil
incorporation).

The
Agency
assessed
exposure
to
terrestrial
organisms
first
predicting
the
amount
of
triadimefon
residues
found
on
animal
food
items
and
then
using
information
on
typical
food
consumption
by
various
species
of
birds
and
mammals
to
determine
the
amount
of
pesticide
consumed.
Estimated
exposure
concentrations
for
terrestrial
animals
(
via
spray
applications)
were
determined
by
using
the
standard
screening­
level
exposure
model,
TREX
(
v.
1.2)
(
US
EPA,
2005),
which
calculates
pesticide
residues
on
each
type
of
food
item
on
a
daily
interval
for
one
year.
Also,
registrant
supported
golf
course
use
rates
and
application
intervals
were
used
(
2
applications
@
2.7
lbs.
ai/
A).

For
a
single
application
there
is
a
linear
relationship
between
the
amount
of
pesticide
applied
and
the
amount
of
pesticide
residue
present
on
a
given
food
item.
These
relationships
for
the
various
food
items
are
determined
from
the
Kenaga
nomogram,
which
is
a
model
developed
by
Hoerger
and
Kenaga
(
1972)
and
modified
by
Fletcher
(
1994).
In
addition
to
incorporating
the
nomogram
relationship,
TREX
also
includes
pesticide
degradation
in
the
estimation
of
EECs.

3)
Bird
and
Mammal
Risk
Birds
There
are
acute
and
chronic
LOC
exceedances
for
birds.
The
turf
maximum
application
rate
of
2
applications
of
2.7
lbs.
ai/
A
at
14
day
intervals
results
in
acute
RQ
LOC
exceedances
that
are
0.14
for
short
grass
only
and
chronic
RQ
LOC
exceedances
that
range
from
4
to
57.
Table
29
shows
the
avian
acute
and
chronic
risk
quotients
for
turf
use
of
triadimefon.
An
avian
acute
assessment
was
not
conducted
for
granular
applications
because
definitive
avian
LD50
values
were
not
available
for
triadimefon
(
no
mortalities
or
signs
of
toxicity
were
seen
in
the
study
at
the
highest
exposure
level).
47
Table
29.
Avian
Dietary­
Based
Acute
and
Chronic
RQs
for
turf
uses
of
Triadimefon
(
based
on
NOAEC
of
20
mg/
kg
diet)
based
on
upper­
bound
Kenaga
values.
Use
(
Application
Rate)
Food
Items
Upper
Bound
EEC
(
mg/
kg)
Acute
Dietary­
Based
RQ
(
EEC/
LC50)
Chronic
Dietary­
Based
RQ
(
EEC/
NOAEC)
Short
grass
1139
0.14
57
Tall
grass
522
0.06
26
Broadleaf
plants/
small
insects
641
0.08
32
Turf
(
2.7
lbs.
a.
i./
A,
2
applications,
14
day
interval)
Fruits,
pods,
seeds,
large
insects
71
0.01
4
Mammals
For
spray
application,
there
are
mammalian
acute
LOC
exceedances
(
LOC
>
0.5)
for
small
and
medium
(
15
and
35g)
mammals
which
consume
short
grass
treated
with
2
applications
@
2.7
lbs.
ai/
A
with
a
14­
day
interval.
Endangered
species
LOCs
are
exceeded
(
LOC>
0.1)
for
all
weight
classes
of
mammals
assessed.
Acute
RQs
are
summarized
below
in
Table
33.

The
predicted
triadimefon
granular
EEC
values
resulting
from
residential
application
at
a
rate
of
2.7
lbs.
ai/
A
(
2
applications,
14­
day
interval)
is
28.12
mg/
ft
2
(
See
Table
30).

Table
30.
Mammalian
Dose­
based
Acute
RQs
for
turf
uses
of
Triadimefon
(
based
on
Triadimenol
LD50
of
689
mg/
kg
in
rats)
based
on
upper­
bound
Kenaga
values.

Spray
Application
Mammalian
Dose­
based
Acute
Risk
Quotients
Use
Body
Weight
(
g)
Adjusted
LD50
Short
grass
Tall
grass
Broadleaf
plants/
small
insects
Fruits/
pod
s/
large
insects
Seeds
15
1514
0.72
0.33
0.40
0.04
0.01
35
1225
0.61
0.28
0.34
0.04
0.01
Turf
(
2.7
lbs.
ai/
A,
2
applications,
14
day
interval)
1000
530
0.33
0.15
0.18
0.02
0.00
Granular
Application
Use
Body
Weight
(
g)
Mg
a.
i./
sq
ft
Adjusted
LD50
Risk
Quotient
15
28.12
1514
1.24
35
28.12
1225
0.66
Turf
(
2.7
lbs.
ai/
A,
2
applications,
14
day
interval)
1000
28.12
530
0.05
In
addition,
there
are
LOC
exceedences
of
mammalian
chronic
risks
ranging
from
1.42
to
23
for
the
turf
maximum
application
rate
of
2
applications
of
2.7
lbs.
a.
i./
A
at
14
day
intervals
(
See
Table
31).
48
Table
31.
Mammalian
Dietary­
based
Chronic
RQs
for
selected
uses
of
non­
granular
Triadimefon
(
based
on
triadimefon
rat
NOAEL
of
50mg/
kg
diet)
and
upper­
bound
Kenaga
values.

Dietary­
based
Chronic
Risk
Quotients
Use
Short
Grass
Tall
Grass
Broadleaf
plants
Fruits/
pods/
large
insects/
seeds
Turf
(
2.7
lbs.
ai/
A,
2
applications,
14
day
interval)
22.78
10.44
12.81
1.42
Additional/
Potential
Dietary
Risks
to
Birds
and
Mammals
Based
on
the
use
of
a
fugacity­
based
(
equilibrium
partitioning)
approach,
an
estimation
of
the
concentration
of
triadimefon
and
its
degradates
in
earthworms
were
calculated
in
order
to
determine
the
possible
contribution
of
earthworm
(
and
other
terrestrial
invertebrate)
consumption
to
mammal
and
avian
risk.
The
calculated
earthworm
tissue
concentrations
of
triadimefon/
triadimenol
suggest
that
ingestion
of
earthworms
by
birds
and
mammals
based
on
dietary
dose
(
triadimefon
NOAEC
=
20
mg/
kg
diet
and
NOAEL
=
2.5
mg/
kg
bw,
respectively)
could
be
another
exposure
pathway
contributing
to
chronic
risk,
although
the
low
earthworm
concentrations
would
necessitate
consumption
of
a
large
number
of
worms.

4)
Non­
target
Terrestrial
Plants
Non­
target
Terrestrial
Plants
No
guideline
studies
evaluating
the
toxicity
of
triadimefon
to
terrestrial
plants
have
been
submitted
to
the
Agency.
However,
although
several
other
studies
within
the
Agency's
database
were
not
suitable
for
use
in
determining
toxicity
endpoints,
they
can
be
interpreted
qualitatively
to
demonstrate
potential
terrestrial
plant
risk
from
triadimefon.
One
such
study
is
summarized
below.

The
regrowth
of
Kentucky
bluegrass
was
inhibited
following
treatment
of
triadimefon.
The
same
study
showed
a
height
decrease
in
kidney
bean
plants.
Although
the
study
did
not
provide
adequate
information
to
quantitatively
calculate
RQ
values
for
nontarget
terrestrial
plants,
the
results
suggest
that
triadimefon
may
have
negative
effects
on
both
monocot
and
dicot
non­
target
terrestrial
plants.
Please
refer
to
the
environmental
fate
and
effects
risk
assessment
for
more
detailed
information.

Based
on
the
supported
maximum
2
applications
for
the
golf
course
use
pattern
for
a
maximum
single
application
of
2.7
lbs.
a.
i./
acre,
there
would
be
no
LOC
exceedances
for
non­
vascular
aquatic
plants.
49
5)
Non­
target
Insects
EPA
currently
does
not
quantify
risks
to
terrestrial
non­
target
insects;
therefore,
risk
quotients
are
not
calculated
for
these
organisms.
Based
on
the
acute
contact
toxicity
study
to
honeybees,
the
LD50
for
triadimefon
is
>
25
ug
ai/
bee
(
MRID
42307804),
which
classifies
it
as
practically
non­
toxic
to
honeybees.
No
data
were
available
for
the
degradate
triadimenol.

3.
Ecological
Incidents
A
review
of
the
Ecological
Incident
Information
System
(
EIIS)
was
completed
on
April
21,
2005.
No
incidents
involving
triadimefon
or
its
metabolite
triadimenol
were
reported.

4.
Endangered
Species
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
results
in
the
determination
that
triadimefon
will
have
no
direct
acute
effects
on
threatened
and
endangered
freshwater
fish,
and
freshwater
aquatic
invertebrates.
However,
the
assessment
indicates
that
triadimefon
has
the
potential
for
causing
risk
to
endangered
birds,
mammals,
and
non­
target
plants.
Further,
potential
indirect
effects
to
any
species
dependent
upon
a
species
that
experiences
effect
cannot
be
precluded
from
use
of
triadimefon.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act.

IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
A.
Determination
of
Reregistration
Eligibility
and
Tolerance
Reassessment
Section
4(
g)(
2)(
A)
of
FIFRA
calls
for
the
Agency
to
determine,
after
submission
of
relevant
data
concerning
an
active
ingredient,
whether
or
not
products
containing
the
active
ingredient
are
eligible
for
reregistration.
The
Agency
has
previously
identified
and
required
the
submission
of
the
generic
(
i.
e.,
active
ingredient­
specific)
data
required
to
support
reregistration
of
products
containing
triadimefon
as
an
active
ingredient.
The
Agency
has
completed
its
review
of
these
generic
data,
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
products
containing
triadimefon.

The
Agency
has
completed
its
assessment
of
the
dietary,
occupational,
residential,
and
ecological
risk
associated
with
the
use
of
pesticide
products
containing
the
active
ingredient
triadimefon.
Based
on
a
review
of
these
data
and
on
public
comments
on
the
Agency's
assessments
for
triadimefon,
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
to
make
decisions
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
process
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
products
containing
triadimefon
are
eligible
for
reregistration
provided
that:
(
i)
required
product­
specific
data
are
submitted;
(
ii)
risk
mitigation
measures
outlined
in
this
document
are
adopted
(
including
requests
for
deletion
of
certain
uses);
and
(
iii)
label
50
amendments
are
made
to
reflect
these
measures.
Label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
triadimefon
that
are
eligible
for
reregistration.
Appendix
B
identifies
the
generic
data
requirements
that
the
Agency
reviewed
as
part
of
its
determination
of
reregistration
eligibility
of
triadimefon,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.

Based
on
its
evaluation
of
triadimefon,
the
Agency
has
determined
that
triadimefon
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA.
Accordingly,
should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
identified
in
this
document,
the
Agency
may
take
regulatory
action
to
address
the
risk
concerns
from
the
use
of
triadimefon.
If
all
changes
outlined
in
this
document
are
implemented,
then
all
current
risks
for
triadimefon
will
be
adequately
mitigated
for
the
purposes
of
this
determination
under
FIFRA.
Additionally,
once
an
endangered
species
assessment
is
completed,
further
changes
to
these
registrations
may
be
necessary,
as
explained
in
Section
IV..
D..
4
of
this
document.
Once
the
uses
that
result
in
risks
of
concern
are
deleted
and
a
cancellation
order
is
issued,
the
Agency
will
take
the
appropriate
regulatory
action
under
FFDCA
to
revoke
the
associated
tolerances.

Triadimenol,
a
metabolite
of
triadimefon,
is
also
a
registered
fungicide.
Triadimenol
was
first
registered
after
1984
and
is
not
subject
to
reregistration
under
the
1988
amendments
to
FIFRA.
Triadimenol
is,
however,
subject
to
tolerance
reassessment
under
the
FFDCA,
as
amended
by
FQPA.
Based
on
its
evaluation
of
combined
exposures
from
the
uses
of
triadimefon,
triadimenol,
and
their
metabolites,
the
Agency
has
determined
that
the
tolerances
for
triadimefon
and
triadimenol
are
considered
to
be
reassessed
under
FFDCA.

B.
Public
Comments
and
Responses
Through
the
Agency's
public
participation
process,
EPA
worked
extensively
with
stakeholders
and
the
public
to
reach
the
regulatory
decisions
for
triadimefon.
EPA
released
its
preliminary
risk
assessments
for
triadimefon
and
triadimenol
for
public
comment
on
February
16,
2006,
for
a
60­
day
public
comment
period
(
Phase
3
of
the
public
participation
process).
During
the
public
comment
period
on
the
risk
assessments,
which
closed
on
April
17,
2006,
the
Agency
received
comments
from
a
public
citizen,
nursery
and
forestry
cooperatives,
the
U.
S.
Triazole
Task
Force,
and
the
technical
registrant
Bayer
CropScience.
These
comments
in
their
entirety,
responses
to
the
comments,
as
well
as
the
preliminary
and
revised
risk
assessments,
are
available
in
the
public
docket
for
triadimefon
(
EPA­
HQ­
OPP­
2005­
0258)
and
for
triadimenol
(
EPA­
HQ­
OPP­
2006­
0038)
in
the
EPA's
electronic
docket
at
http://
www.
regulations.
gov.

C.
Regulatory
Position
under
the
FFDCA
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
51
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
this
pesticide.
The
Agency
has
determined
that,
if
the
mitigation
described
in
this
document
is
adopted
and
labels
are
amended,
human
health
risks
as
a
result
of
exposures
to
triadimefon
and
triadimenol
are
within
acceptable
levels.
In
other
words,
EPA
has
concluded
that
the
tolerances
for
triadimefon
and
triadimenol
will
meet
FQPA
safety
standards.
In
reaching
this
determination,
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
exposures
to
triadimefon
and
triadimenol
from
all
possible
sources.
Furthermore,
if
the
registrant
does
not
cancel
the
uses
agreed
to
or
make
the
mitigation
changes
necessary
to
meet
the
safety
determination,
the
Agency
will
take
the
appropriate
regulatory
action.

b.
Determination
of
Safety
to
U.
S.
Population
The
Agency
has
determined
that
the
established
tolerances
for
triadimefon
and
triadimenol,
with
amendments
and
changes
as
specified
in
this
document,
will
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
D)
of
the
FFDCA,
and
that
there
is
a
reasonable
certainty
no
harm
will
result
to
the
general
population
or
any
subgroup
from
the
use
of
triadimefon
and
triadimenol.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
triadimefon
and
triadimenol
and
their
free
triazole
degradates.

As
discussed
in
Section
III,
the
aggregate
risks
from
triadimefon
and
triadimenol
from
food,
drinking
water,
and
residential
exposure
are
not
of
concern,
provided
the
mitigation
measures
described
in
this
document
are
implemented
through
amendments
to
existing
registrations.
Furthermore,
aggregate
risks
from
the
free
triazoles
(
1,2,4­
triazole,
triazole
acetic
acid,
and
triazole
alanine)
are
not
of
concern.
The
aggregate
risk
assessment
for
the
free
triazoles
considers
all
currently
registered
uses
of
all
triazole
fungicides.

c.
Determination
of
Safety
to
Infants
and
Children
EPA
has
determined
that
the
established
tolerances
for
triadimefon
and
triadimenol,
with
amendments
and
changes
as
specified
in
this
document,
will
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
factors
on
the
toxicity,
use
practices
and
environmental
behavior
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
triadimefon
and
triadimenol
residues
in
this
population
subgroup.

d.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
52
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
to
include
evaluations
of
potential
effects
in
wildlife.
For
pesticides,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

e.
Cumulative
Risks
Section
408(
b)(
2)(
D)(
v)
of
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
Other
substances
are
considered
to
account
for
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
each
individual
substance.
For
the
purposes
of
this
regulatory
decision,
EPA
has
concluded
that
triadimefon
and
triadimenol
do
not
share
a
common
mechanism
of
toxicity
with
other
substances.
The
Agency
reached
this
conclusion
after
a
thorough
internal
review
and
external
review
of
the
data
supporting
a
common
mechanism
of
toxicity
for
a
number
of
chemical
classes.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
http://
www.
epa.
gov/
pesicides/
cumulative/.

2.
Tolerance
Summary
for
Triadimefon
Tolerances
of
triadimefon
in/
on
plant
and
livestock
commodities
(
40
CFR
§
180.410)
are
presently
expressed
in
terms
of
residues
of
triadimefon
and
its
metabolites
containing
chlorophenoxy
and
triazole
moieties
(
expressed
as
the
parent
compound).

a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.410
Tolerances
are
established
for
residues
of
triadimefon
[
1­(
4­
chlorophenoxy)­
3,3­
dimethyl­
1­(
1H­
1,2,4­
triazol­
1­
yl)­
2­
butanone]
and
its
metabolites
containing
chlorophenoxy
and
triazole
moieties
(
expressed
as
the
parent
compound)
in/
on
various
plant
and
animal
commodities
[
40
CFR
§
180.410].
The
established
tolerances
for
residues
in
plant
and
animal
commodities
[
40
CFR
§
180.410(
a)]
range
from
0.04
ppm
(
milk,
hog,
and
poultry
commodities)
to
145
ppm
(
grass
seed
cleanings).
A
tolerance
with
regional
registration
is
established
for
triadimefon
and
its
metabolites
in/
on
raspberries
at
2.0
ppm
[
40
CFR
53
§
180.410(
c)].
However,
all
triadimefon
tolerances
(
except
pineapple)
will
be
proposed
for
revocation.

Residues
of
triadimenol
(
and
its
butanediol
metabolite
KWG
1342),
from
use
of
triadimenol
per
se,
are
regulated
separately
under
40
CFR
§
180.450.
In
addition,
40
CFR
§
180.3(
d)(
13)
specifies
that
where
tolerances
are
established
for
residues
of
both
1­(
4­
chlorophenoxy)­
3,3­
dimethyl­
1­(
1H­
1,2,4­
triazole­
1­
yl)­
2­
butanone
(
triadimefon)
and
 ­(
4­
chlorophenoxy)­
 ­(
1,1­
dimethylethyl)­
1H­
1,2,4­
triazole­
1­
ethanol
(
triadimenol)
including
its
butanediol
metabolite,
1­(
4­
chlorophenoxy)­
3,3­
dimethyl­
3­
hydroxymethyl­
1­(
1H­
1,2,4­
triazol­
1­
yl)­
2­
butanol
(
KWG1342),
in
or
on
the
same
raw
agricultural
commodity
and
its
products
thereof,
the
total
amount
of
such
residues
shall
not
yield
more
residue
than
that
permitted
by
the
higher
of
the
two
tolerances.
Currently,
triadimefon
and
triadimenol
do
not
share
any
uses,
so
40
CFR
§
180.3(
d)(
13)
should
be
deleted.
A
tolerance
summary
for
triadimefon
is
presented
in
Table
32.

Table
32.
Tolerance
Summary
for
Triadimefon
Commodity
Current
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comments
Tolerances
Established
Under
40
CFR
§
180.410(
a)

Apple
1
Revoke
Bayer
is
voluntarily
deleting
this
use.

Apple,
wet
pomace
and
Apple,
dry
pomace
4
Revoke
Bayer
is
voluntarily
deleting
this
use.

Barley,
milled
fractions
(
except
flour)
4
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
barley.

Beet,
sugar
0.5
Beet,
sugar,
tops
3
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
sugar
beets.

Cattle,
fat
1
Revoke
Cattle,
meat
1
Revoke
Cattle,
meat
byproducts
1
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
cattle
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Chickpea,
seed
0.1
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
chickpea
plants.

Cucurbits
0.3
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
chickpea
plants.

Eggs
0.04
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
poultry
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Goat,
fat
1
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
goat
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
54
Commodity
Current
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comments
Goat,
meat
1
Revoke
Goat,
meat
byproducts
1
Revoke
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Grape
1
Revoke
Bayer
is
voluntarily
deleting
this
use.

Grape,
wet
pomace
and
Grape,
dry
pomace
3
Grape,
raisin,
waste
7
Revoke
No
longer
considered
significant
livestock
feed
items.

Grass,
forage
0.2
Grass,
seed
screenings
145
Grass,
straw,
grown
for
seed
105
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
pasture
or
rangeland.

Hog,
fat
0.04
Hog,
meat
0.04
Hog,
meat
byproducts
0.04
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
hog
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Horse,
fat
1
Horse,
meat
1
Horse,
meat
byproducts
1
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
horse
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Milk
0.04
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
cattle
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Nectarine
4
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
nectarine.

Pear
1
Revoke
Bayer
is
voluntarily
deleting
this
use.

Pineapple,
fresh
3
2
Re­
evaluation
of
data
from
field
trials
shows
lower
residues
are
expected.

[
Pineapple]

Poultry,
fat
0.04
Poultry,
meat
0.04
Poultry,
meat
byproducts
0.04
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
poultry
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.
55
Commodity
Current
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comments
Raspberry
2
Revoke
Bayer
is
voluntarily
deleting
this
use.

40
CFR
§
180.410(
c)
A
tolerance
with
regional
registration
is
established
for
triadimefon
and
its
metabolites
in/
on
raspberries.

Sheep,
fat
1
Sheep,
meat
1
Sheep,
meat
byproducts
1
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
any
sheep
feed
items.

40
CFR
§
180.6(
a)(
3)
It
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred
but
there
is
no
reasonable
expectation
of
finite
residues.

Wheat,
forage
15
Wheat,
grain
1
Wheat,
milled
fractions
(
except
flour)
4
Wheat,
straw
5
Revoke
Currently,
Bayer
does
not
have
any
registered
uses
of
triadimefon
on
wheat.

b.
Codex
Harmonization
No
Codex
maximum
residue
levels
(
MRLs)
have
been
established
for
triadimefon.

The
Codex
Alimentarius
Commission
(
Codex)
has
established
several
MRLs
for
triadimenol
in/
on
various
raw
agricultural
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
triadimenol
per
se.
The
MRLs
have
been
established
to
accommodate
triadimenol
residues
resulting
from
the
use
of
triadimefon
and/
or
triadimenol.
Compatibility
cannot
be
achieved
with
the
Codex
MRLs
because
these
levels
are
expressed
in
terms
of
triadimenol
only;
the
U.
S.
tolerances
for
plant
commodities
are
expressed
in
terms
of
triadimenol,
KWG
1342,
and
KWG
1732
in/
on
cereal
grains
and
cotton
and
triadimenol
and
KWG
1342
in/
on
bananas..

c.
Residue
Analytical
Methods
 
Plants/
Livestock
The
reregistration
requirements
for
residue
analytical
methods
are
fulfilled.
Adequate
methods
are
available
for
data
collection
and
for
the
enforcement
of
tolerances
for
residues
of
triadimefon
per
se
in/
on
plant
commodities.
Since
there
is
no
reasonable
expectation
of
residues
in
poultry,
enforcement
methods
for
the
determination
of
triadimefon
residues
in
livestock
commodities
are
not
needed.

Plant
Commodities.
Two
methods
of
gas
chromatography
with
mass
spectrometry
detection
(
GC/
MS)
are
listed
in
the
Pesticide
Analytical
Manual
(
PAM
Vol.
II)
for
enforcement
of
tolerances
in
plant
and
livestock
commodities.
The
methods
use
a
single
moiety
detection
in
which
residues
are
converted
to
p­
dichlorophenol,
derivatized
with
dinitrofluorobenzene,
and
reported
as
triadimefon
equivalents.
The
GC/
MS
method
is
no
56
longer
adequate
due
to
the
recommended
tolerance
expression
revisions.
However,
a
GC
method
using
a
nitrogen
phosphorus
detector
(
NPD;
Report
No.
80488)
is
available
for
determination
of
residues
of
triadimefon,
triadimenol,
KWG
1323,
and
KWG
1342,
and
it
is
adequate
for
the
enforcement
of
a
pineapple
tolerance.
The
reported
method
limit
of
quantitation
(
LOQ)
is
0.01
ppm
for
each
analyte.
The
limit
of
detection
(
LOD)
was
not
reported.

Livestock
Commodities.
The
Pesticide
Analytical
Manual
(
PAM)
Vol.
II
lists
the
two
GC/
MS
methods
described
above
(
Methods
I
and
II)
for
the
determination
of
triadimefon
and
its
free
and
conjugated
metabolites
in
livestock
commodities.
Method
I
(
Report
No.
69531)
is
appropriate
for
livestock
tissues
and
milk
and
Method
II
(
Report
No.
80265)
is
appropriate
for
livestock
tissues
and
eggs.
The
reported
LOQ
is
0.05
and
the
LOD
is
0.01
ppm
for
both
methods.

Multiresidue
Methods.
The
10/
99
FDA
PESTDATA
database
(
PAM
Volume
I,
Appendix
I)
indicates
that
triadimefon
is
completely
recovered
(>
80%)
using
Multiresidue
Methods
Section
302
(
Luke
Method;
Protocol
D);
recovery
of
triadimefon
is
small
(<
50%)
using
Multiresidue
Methods
Sections
303
(
Mills,
Onley,
and
Gaither;
Protocol
E,
nonfatty)
and
304
(
Mills,
fatty
food).
Triadimefon
metabolites
triadimenol
and
KWG
1323
are
completely
recovered
using
Section
302.
Triadimenol,
KWG
1323,
and
metabolite
KWG
1732
are
not
recovered
using
Sections
303
and
304.

3.
Tolerance
Summary
for
Triadimenol
The
current
tolerance
expression
for
residues
of
triadimenol
resulting
from
direct
application
to
primary
crops
is
adequate.
The
Agency
has
determined
that
the
tolerance
expression
for
residues
in/
on
cereal
grains
(
barley,
corn,
oats,
rye,
and
wheat)
and
cotton
commodities
should
include
only
triadimenol
and
its
metabolites
KWG
1342,
and
KWG
1732.
However,
the
tolerance
expression
for
residues
in/
on
bananas
should
include
only
triadimenol
and
its
metabolite
KWG
1342.
A
summary
of
triadimenol
tolerance
reassessments
is
presented
in
Table
33.

a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.450
Tolerances
are
established
for
residues
of
triadimenol
and
its
butanediol
metabolite,
4­(
4­
chlorophenoxy)­
2,2­
dimethyl­
4­(
1H­
1,2,4­
triazol­
1­
yl)­
1,3­
butanediol
(
calculated
as
triadimenol)
in/
on
various
plant
commodities.
The
established
tolerances
in
plant
commodities
range
from
0.01
(
sorghum
grain
and
fodder)
to
2.5
ppm
(
green
forage
of
oats,
rye,
and
wheat).
Tolerances
are
currently
established
for
residues
of
triadimenol
and
its
metabolites
containing
the
chlorophenoxy
moiety
(
calculated
as
triadimenol)
in
livestock
commodities
at
0.01
ppm
(
milk
and
poultry
commodities)
and
0.1
ppm
(
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep).

Tolerances
Needed
Under
40
CFR
§
180.450(
a):

Triadimenol
is
registered
for
use
on
barley,
corn,
cotton,
oats,
rye,
sorghum,
wheat,
57
and
bananas
as
an
import
tolerance
only;
however,
there
are
no
existing
tolerances
associated
with
barley
(
hay),
oat
(
hay),
wheat
(
hay),
and
cotton
(
gin
byproducts).
Therefore,
tolerances
will
need
to
be
established
for
these
crops.

Tolerances
Under
40
CFR
§
180.450(
b):

The
reregistration
requirements
for
data
depicting
the
magnitude
of
triadimenol
residues
of
concern
in
meat,
milk,
poultry,
and
eggs
have
been
fulfilled.
Acceptable
ruminant
and
poultry
feeding
studies
have
been
submitted
and
evaluated.
Triadimenol
is
not
registered
for
use
as
a
direct
livestock
treatment.
The
nature
of
the
residue
in
livestock
is
adequately
defined
for
the
current
uses.
The
Agency
has
concluded
that
the
supported
uses
on
barley,
corn,
cotton,
oats,
rye,
and
wheat
result
in
a
40
CFR
§
180.6(
a)(
3)
situation
for
ruminant
commodities
(
i.
e.,
there
is
no
reasonable
expectation
of
finite
residues
in
ruminant
commodities).
Therefore,
additional
data
on
the
transfer
of
residues
to
meat,
milk,
poultry,
and
eggs
are
not
required
and
all
tolerances
for
triadimenol
residues
in
livestock
commodities
should
be
revoked
pending
results
from
the
requested
corn
and
wheat
metabolism
studies.
If,
however,
foliar
uses
or
registration
on
additional
major
livestock
feed
items
are
requested,
then
triazole
and
phenyl­
labeled
livestock
metabolism
studies
would
be
required.
Such
data
may,
in
turn,
trigger
the
need
for
magnitude
of
the
residue
(
feeding)
studies
in
livestock.

Table
33.
Tolerance
Summary
for
Triadimenol
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/
[
Correct
Commodity
Definition]

Tolerances
Established
Under
40
CFR
§
180.450(
a)
Banana
(
Whole)
1
0.2
0.2
Barley,
grain
0.05
TBD2
Barley,
straw
0.2
TBD2
Corn,
forage
0.05
TBD2
[
Corn,
field,
forage]
[
Corn,
sweet,
forage]

Corn,
fresh
(
including
sweet),
(
K+
CWHR)
0.05
TBD2
[
Corn,
sweet,
K+
CWHR]

Corn,
grain
0.05
TBD2
[
Corn,
field,
grain]
[
Corn,
pop,
grain]

Corn,
stover
0.05
TBD2
[
Corn,
field,
stover]
[
Corn,
pop,
stover]
[
Corn,
sweet,
stover]

Cotton,
forage
0.02
Revoke
No
longer
considered
a
significant
livestock
feed
item.

Cotton,
undelinted
seed
0.02
TBD2
Oat,
grain
0.05
TBD2
Oat,
forage
2.5
TBD2
Oat,
straw
0.2
TBD2
Rye,
forage
2.5
TBD2
Rye,
grain
0.05
TBD2
Rye,
straw
0.1
TBD2
58
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/
[
Correct
Commodity
Definition]

Tolerances
Established
Under
40
CFR
§
180.450(
a)

Sorghum,
forage,
hay
0.05
Revoke
Use
is
not
being
supported.

Sorghum,
grain
0.01
Revoke
Use
is
not
being
supported.

Sorghum,
grain,
stover
0.01
Revoke
Use
is
not
being
supported.

Wheat,
forage
2.5
TBD2
Wheat,
grain
0.05
TBD2
Wheat,
straw
0.2
TBD2
Tolerances
Established
Under
40
CFR
§
180.450(
b)

Cattle,
fat
0.1
Cattle,
meat
0.1
Cattle,
meat
byproducts
0.1
Revoke
Available
data
indicate
that
tolerances
for
cattle
commodities
are
not
required.

Egg
0.01
Revoke
Available
data
indicate
that
a
tolerance
for
egg
is
not
required.
Goat,
fat
0.1
Goat,
meat
0.1
Goat,
meat
byproducts
0.1
Revoke
Available
data
indicate
that
tolerances
for
goat
commodities
are
not
required.

Hog,
fat
0.1
Hog,
meat
0.1
Hog,
meat
byproducts
0.1
Revoke
Available
data
indicate
that
tolerances
for
hog
commodities
are
not
required.

Horse,
fat
0.1
Horse,
meat
0.1
Horse,
meat
byproducts
0.1
Revoke
Available
data
indicate
that
tolerances
for
horse
commodities
are
not
required.

Milk
0.01
Revoke
Available
data
indicate
that
a
tolerance
for
milk
is
not
required.
Poultry,
fat
0.01
Poultry,
meat
0.01
Poultry,
meat
byproducts
0.01
Revoke
Available
data
indicate
that
tolerances
for
poultry
commodities
are
not
required.

Sheep,
fat
0.1
Sheep,
meat
0.1
Sheep,
byproducts
0.1
Revoke
Available
data
indicate
that
tolerances
for
sheep
commodities
are
not
required.

Tolerances
T
Be
Proposed
Under
40
CFR
§
180.450(
a)

Barley,
hay
None
established
TBD2
Cotton,
gin
byproducts
None
established
TBD2
Oat,
hay
None
established
TBD2
Wheat,
hay
None
established
TBD2
140
CFR
§
180.450(
a)
states
that
there
are
no
U.
S.
registrations
for
bananas
(
whole).
2TBD
=
To
be
determined.
Additional
data
are
required.
Note
that
while
additional
data
are
needed,
there
are
no
dietary
risks
associated
with
these
tolerances
and
EPA
considers
them
reassessed.

D.
Regulatory
Rationale
under
FIFRA
59
The
Agency
has
determined
that
triadimefon
is
eligible
for
reregistration,
in
compliance
with
FIFRA,
and
the
associated
tolerances
are
considered
reassessed,
provided
that:
1)
required
product­
specific
and
generic
data
are
submitted;
2)
risk
mitigation
measures
(
including
requests
to
delete
certain
uses)
outlined
in
this
document
are
adopted;
and
3)
label
amendments
are
made
to
reflect
these
measures.
As
stated
above,
the
Agency
will
take
steps
to
revoke
the
tolerances
associated
with
the
uses
that
are
being
deleted.

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.
Product­
specific
and
generic
data
are
required
to
be
submitted,
as
specified
in
section
V.

The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
triadimefon.
Where
labeling
revisions
are
required,
specific
language
is
set
forth
in
the
summary
tables
of
Chapter
V
of
this
document.

1.
Human
Health
Risk
Management
a.
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
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.

b.
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;
60
 
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.

c.
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
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;
61
 
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.

d.
Aggregate
Risk
Mitigation
for
Triazole
Metabolites
Acute,
short­
and
intermediate­
term,
and
chronic
aggregate
risks
for
degradates
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid
are
below
the
Agency's
level
of
concern.
The
Agency
considered
the
contribution
of
acute
and
chronic
dietary
risks
from
food
and
drinking
water
as
well
as
residential
handler
and
post­
application
exposures
in
the
aggregate
risk
assessment
for
the
free
triazoles.
Therefore,
no
further
mitigation
is
necessary
at
this
time.

2.
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).

3.
Other
Labeling
In
order
to
be
eligible
for
reregistration,
various
use
and
safety
information
will
be
required
in
the
labeling
of
all
end­
use
products
containing
triadimefon.
For
the
specific
labeling
statements
and
a
list
of
outstanding
data,
refer
to
Section
V
of
this
RED
document.

4.
Endangered
Species
Program
62
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
results
in
the
determination
that
triadimefon
will
have
no
direct
acute
effects
on
threatened
and
endangered
freshwater
fish,
and
freshwater
aquatic
invertebrates.
However,
the
assessment
indicates
that
triadimefon
has
the
potential
for
causing
acute
risk
to
endangered
birds,
mammals,
and
non­
vascular
aquatic
plants.
Chronic
RQs
for
endangered
mammals
exceed
the
level
of
concern
at
all
application
rates
modeled.
Chronic
RQs
for
endangered
birds
also
exceed
the
level
of
concern.
No
data
are
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.

Further,
potential
indirect
effects
to
any
species
dependent
upon
a
species
that
experiences
effect
cannot
be
precluded
from
use
of
triadimefon.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act.

The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
that
may
affect
any
particular
species,
EPA
uses
basic
toxicity
and
exposure
data
developed
for
the
REDs
and
considers
ecological
parameters,
pesticide
use
information,
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
This
analysis
will
consider
the
risk
mitigation
measures
that
are
being
implemented
as
a
result
of
this
regulatory
decision.

Following
this
future
species­
specific
analysis,
a
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
or
its
critical
habitat
may
result
in:
limitations
on
the
use
of
triadimefon;
other
measures
to
mitigate
any
potential
impact;
or
consultations
with
the
Fish
and
Wildlife
Service
or
the
National
Marine
Fisheries
Service
as
necessary.
If
the
Agency
determines
that
use
of
triadimefon
"
may
affect"
listed
species
or
their
designated
critical
habitat,
EPA
will
employ
the
provisions
in
the
Services
regulations
(
50
CFR
Part
402).
Until
that
species­
specific
analysis
is
completed,
the
risk
mitigation
measures
being
implemented
through
this
RED
will
reduce
the
likelihood
that
endangered
and
threatened
species
may
be
exposed
to
triadimefon
at
levels
of
concern.
EPA
is
not
requiring
specific
triadimefon
label
language
at
the
present
time
relative
to
threatened
and
endangered
species.
If,
in
the
future,
specific
measures
are
necessary
for
the
protection
of
listed
species,
the
Agency
will
implement
them
through
the
Endangered
Species
Protection
Program.

V.
What
Registrants
Need
to
Do
The
use
of
currently
registered
products
containing
triadimefon
in
accordance
with
approved
labeling
will
not
pose
unreasonable
risks
or
adverse
effects
to
humans
or
the
environment
provided
that
the
risk
mitigation
measures
and
label
changes
(
including
use
63
deletions)
outlined
in
this
document
are
implemented.
Therefore,
all
remaining
uses
of
these
products
are
eligible
for
reregistration.
These
products
will
be
reregistered
once
the
required
confirmatory
generic
data,
product
specific
data,
CSFs,
and
revised
labeling
are
received
and
accepted
by
EPA.
Products
that
contain
other
ingredients
in
addition
to
triadimefon
will
be
reregistered
when
all
of
their
other
active
ingredients
are
also
reregistered.

A.
For
triadimefon
technical
grade
active
ingredient
products,
the
registrant
needs
to
submit
the
following
items:

Within
90
days
from
receipt
of
the
generic
data
call
in
(
DCI):

1.
Completed
response
forms
to
the
generic
DCI
(
i.
e.,
DCI
response
form
and
requirements
status
and
registrant's
response
form);
and
2.
Any
time
extension
and/
or
waiver
requests
with
a
full
written
justification.

Within
the
time
limit
specified
in
the
generic
DCI:

1.
Citations
of
any
existing
generic
data
that
address
data
requirements
or
submit
new
generic
data
responding
to
the
DCI.

Please
contact
John
W.
Pates,
Jr.
at
(
703)
308­
8195
with
questions
regarding
generic
reregistration.

By
U.
S.
Mail:
By
express
or
courier
service:
Document
Processing
Desk
(
DCI/
SRRD)
Document
Processing
Desk
(
DCI/
SRRD)
John
W.
Pates,
Jr.
John
W.
Pates,
Jr.
U.
S.
EPA
(
7508P)
Office
of
Pesticide
Programs
(
7504P)
1200
Pennsylvania
Ave.,
NW
Room
S­
4900
Washington,
DC
20460
One
Potomac
Yard
Arlington,
VA
22202
B.
For
end­
use
products
containing
the
active
ingredient
triadimefon,
the
registrant
needs
to
submit
the
following
items
for
each
product:

Within
90
days
from
the
receipt
of
the
product­
specific
data
call­
in
(
PDCI):

(
1)
completed
response
forms
to
the
PDCI
(
i.
e.,
PDCI
response
form
and
requirements
status
and
registrant's
response
form);
and
(
2)
any
time
extension
or
waiver
requests
with
a
full
written
justification.

Within
eight
months
from
the
receipt
of
the
PDCI:

(
1)
two
copies
of
the
confidential
statement
of
formula
(
EPA
Form
8570­
4);
64
(
2)
a
completed
original
application
for
reregistration
(
EPA
Form
8570­
1).
Indicate
on
the
form
that
it
is
an
"
application
for
reregistration";

(
3)
five
copies
of
the
draft
label,
incorporating
all
label
amendments
outlined
in
Table
33
of
this
document;

(
4)
a
completed
form
certifying
compliance
with
data
compensation
requirements
(
EPA
Form
8570­
34);

(
5)
if
applicable,
a
completed
form
certifying
compliance
with
cost
share
offer
requirements
(
EPA
Form
8570­
32);
and
(
6)
the
product­
specific
data
responding
to
the
PDCI.

Please
contact
Veronica
Dutch
at
(
703)
308­
8047
with
questions
regarding
product
reregistration
and/
or
the
PDCI.
All
materials
submitted
in
response
to
the
PDCI
should
be
addressed:

By
US
mail:
By
express
or
courier
service
only:
Document
Processing
Desk
(
PDCI/
PRB)
Document
Processing
Desk
(
PDCI/
PRB)
Veronica
Dutch
Veronica
Dutch
US
EPA
(
7508P)
Office
of
Pesticide
Programs
(
7504P)
1200
Pennsylvania
Ave.,
NW
Room
S­
4900
Washington,
DC
20460
One
Potomac
Yard
Arlington,
VA
22202
A.
Manufacturing
Use
Products
1.
Generic
Data
Requirements
for
Triadimefon
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
this
RED:

Human
Health
Effects
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Developmental
Neurotoxicity
Study
(
DNT)
870.6300
83­
6
Ecological
Effects
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Estuarine/
Marine
Mollusk
EC50
850.1025
72­
3
B
Estuarine/
Marine
Shrimp
EC50
850.1035
72­
3
C
Estuarine/
Marine
Fish
LC50
850.1075
72­
3
A
65
Seedling
Emergence
850.4225
123­
1
A
Vegetative
Vigor
850.4250
123­
1
B
Aquatic
Vascular
Plant
Growth
850.4400
123­
2
2.
Labeling
for
Manufacturing­
Use
Products
To
ensure
compliance
with
FIFRA,
manufacturing­
use
product
(
MUP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices,
and
applicable
policies.
The
MUP
labeling
should
bear
the
labeling
contained
in
the
labeling
table,
which
will
be
issued
separately.

B.
End­
Use
Products
1.
Additional
Product­
Specific
Data
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
productspecific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
The
Registrant
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.

A
product­
specific
data
call­
in,
outlining
specific
data
requirements,
accompanies
this
RED.

2.
Labeling
for
End­
Use
Products
Labeling
changes
are
necessary
to
implement
measures
outlined
in
Section
IV
above.
Specific
language
to
incorporate
these
changes
is
specified
in
Table
34.

C.
Data
Requirements
for
Triadimenol
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
this
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
this
document.

Product
Chemistry
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Stability
830.6313
63­
13
pH
(
H20
solutions)
830.7000
63­
12
Ultraviolet/
visible
Absorption
830.7050
None
Partition
Coefficient
(
N­
octanol/
water)
830.7550
830.7560
OR
63­
11
66
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

830.7570
Water
Solubility
830.7840
OR
830.7860
63­
8
Toxicology
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Acute
neurotoxicity
study
870.6100
81­
7
Subchronic
neurotoxicity
Study
870.6200
82­
7
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.

D.
Labeling
Changes
Summary
Table
For
triadimefon
to
be
eligible
for
reregistration,
all
triadimefon
labels
must
be
amended
to
incorporate
the
risk
mitigation
measures
outlined
in
Section
IV.
Table
34
describes
how
language
on
the
labels
should
be
amended.
67
Table
34.
Labeling
Changes
Summary
Table
Summary
of
Labeling
Changes
for
Triadimefon
Description
Amended
Labeling
Language
Placement
on
Label
Manufacturing
Use
Products
Only
for
formulation
into
a
fungicide
for
the
following
use(
s):
golf
course
turfgrass,
sodfarm
turfgrass,

outdoor­
and
greenhouse­
grown
ornamentals
(
trees,
shrubs,
flowering
plants,
including
roses),
azaleas
(
for
control
of
pine­
twisting
rust
only),
pine
trees
(
including
Christmas
trees),
pine
seedlings,
pine
seeds,

and
pineapple
(
preplant
dip
and
postharvest
dip
only),
"

"
This
product
can
not
be
formulated
into
end­
use
products
with
directions
for
use
in
residential
or
commercial
settings
on
apples,
grapes,
pears,
raspberries,
azaleas
(
except
to
control
pine­
twisting
rust
only),
or
turfgrass
(
except
for
turfgrass
on
golf
courses
or
sodfarms)."

"
This
product
can
not
be
formulated
into
liquid
concentrate
end­
use
products
with
directions
for
use
on
azaleas,
pine
seedlings,
pine
seeds,
or
pineapple."

"
This
product
can
not
be
formulated
into
dry
flowable
end­
use
products
with
directions
for
use
on
pine
trees,
pine
seedlings,
or
pineapple."

"
This
product
can
be
formulated
into
granular
end­
use
products
with
directions
for
use
only
on
golf
course
turfgrass
or
sodfarm
turfgrass."
Directions
for
Use
One
of
these
statements
may
be
added
to
a
label
to
allow
reformulation
of
the
product
for
a
specific
use
or
all
additional
uses
supported
by
a
formulator
or
user
group
"
This
product
may
be
used
to
formulate
products
for
specific
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."
Directions
for
Use
Environmental
Hazards
"
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,
estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance,
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
68
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

PPE
Requirements
Established
by
the
RED1
for
liquid
concentrate
end­
use
products
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
material).
If
you
want
more
options,
follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
A
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
flaggers,
and
other
handlers
must
wear:

>
Long
sleeved
shirt
and
long
pants,

>
Shoes
plus
socks,
and
>
Chemical
resistant
gloves,
such
as
(
registrant
insert
correct
chemical­
resistant
materials)
when
mixing/
loading
or
when
applying
using
handheld
equipment
or
handheld
nozzles."

"
See
engineering
controls
for
additional
requirements."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
for
dry
flowable
end­
use
products
Note:
if
the
end­
use
product
does
not
have
directions
for
use
as
a
seed
treatment,
then
the
phrase
"
or
when
handling
treated
seed
(
including
spreading,
drying,
raking,

bagging,
and
sewing
seed
bags)"
may
be
dropped.
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
material).
If
you
want
more
options,
follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
A
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators,
flaggers,
and
other
handlers
must
wear:

>
Long
sleeved
shirt
and
long
pants,

>
Shoes
plus
socks,
and
>
Chemical
resistant
gloves,
such
as
(
registrant
insert
correct
chemical­
resistant
materials)
when
mixing/
loading,
when
applying
using
handheld
equipment
or
handheld
nozzles,
or
when
handling
treated
seed
(
including
spreading,
drying,
raking,
bagging,
and
sewing
seed
bags)."

"
See
engineering
controls
for
additional
requirements."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
for
wettable
powder
end­
use
products
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
material).
If
you
want
more
options,
follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
A
on
an
EPA
chemical­
resistance
category
selection
chart."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
69
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

Note:
all
wettable
powder
products
must
be
in
water
soluble
packets
to
be
eligible
for
reregistration.

Note:
if
the
end­
use
product
does
not
have
directions
for
use
as
a
seed
treatment,
then
the
phrase
"
or
when
handling
treated
seed
(
including
spreading,
drying,
raking,

bagging,
and
sewing
seed
bags)"
may
be
dropped.

Note:
if
the
end­
use
product
does
not
have
directions
for
use
as
a
dip
treatment,
then
the
phrases
"
participating
in
dip
applications"
may
be
dropped.
"
Mixers,
loaders,
applicators,
flaggers,
and
other
handlers
must
wear:

>
Long
sleeved
shirt
and
long
pants,

>
Shoes
plus
socks,

>
Chemical
resistant
gloves,
such
as
(
registrant
insert
correct
chemical­
resistant
materials)
when
mixing/
loading,
when
using
handheld
equipment
or
handheld
nozzles,
when
participating
in
dip
applications,
or
when
handling
treated
seed
(
including
spreading,
drying,
raking,
bagging,
and
sewing
seed
bags),
and
>
Chemical­
resistant
apron,
when
mixing/
loading,
when
participating
in
dip
applications,
or
cleaning
spills
or
equipment."

"
See
engineering
controls
for
additional
requirements."

PPE
Requirements
Established
by
the
RED1
for
granular
products
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
material).
If
you
want
more
options,
follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
A
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Loaders,
applicators,
flaggers,
and
other
handlers
must
wear:

>
Long­
sleeved
shirt
and
long
pants,

>
Shoes
plus
socks,
and
>
Chemical
resistant
gloves,
such
as
(
registrant
insert
correct
chemical­
resistant
materials)
when
loading."

"
See
engineering
controls
for
additional
requirements."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
70
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

PPE
Requirements
Established
by
the
RED1
for
ready­
to­
use
briquette
products
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
material).
If
you
want
more
options,
follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Applicators
and
other
handlers
must
wear:

>
Long­
sleeved
shirt
and
long
pants,

>
Shoes
plus
socks,
and
>
Chemical
resistant
gloves,
such
as
(
registrant
insert
correct
chemical­
resistant
materials).
"
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED1
for
tree­
injection
products
Note:
if
the
tree­
injection
product
is
ready­
to­
use,
the
words
"
mixers,
loaders"
may
be
dropped
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
material).
If
you
want
more
options,
follow
the
instructions
for
category
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

"
Mixers,
loaders,
applicators
and
other
handlers
must
wear:

>
Long­
sleeved
shirt
and
long
pants,

>
Shoes
plus
socks,
and
>
Chemical
resistant
gloves,
such
as
(
registrant
insert
correct
chemical­
resistant
materials)."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
User
Safety
Requirements
"
Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
and
wash
PPE
separately
from
other
laundry."

"
Discard
clothing
and
other
absorbent
materials
that
have
been
drenched
or
heavily
contaminated
with
this
product's
concentrate.
Do
not
reuse
them."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
71
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

Engineering
Controls
for
liquid,
dry
flowable
,
or
granular
formulations
that
contain
directions
for
use
for
sodfarm
turfgrass
"
Engineering
Controls"

"
Pilots
must
use
an
enclosed
cockpit
in
a
manner
that
is
consistent
with
the
WPS
for
Agricultural
Pesticides
[
40
CFR170.240(
d)(
6)].
Pilots
must
wear
the
PPE
required
on
this
labeling
for
applicators."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
(
Immediately
following
PPE
and
User
Safety
Requirements.)

Engineering
Controls
for
wettable
powders
packaged
in
water­
soluble
packets.
All
wettable
powders
must
be
in
water
soluble
packets
to
be
eligible
for
reregistration.
"
Engineering
Controls"

"
Water
soluble
packets
when
used
correctly
qualify
as
a
closed
mixing/
loading
system
under
the
Worker
Protection
Standard
for
Agricultural
Pesticides
[
40
CFR
170.240(
d)(
4).
Mixers
and
loaders
using
water
soluble
packets
must:

­
wear
the
personal
protective
equipment
required
on
this
labeling
for
mixers
and
loaders,
and
­
be
provided,
have
immediately
available,
and
wear
in
an
emergency,
such
as
a
broken
package,
spill,
or
equipment
breakdown:

>
chemical
resistant
footwear
and
>
a
NIOSH­
approved
respirator
equipped
with:

­­
a
dust/
mist
filter
with
MSHA/
NIOSH
approval
number
prefix
TC­
21C
or
­­
any
N,
R,
P,
or
HE
filter."

"
Pilots
must
use
an
enclosed
cockpit
in
a
manner
that
is
consistent
with
the
WPS
for
Agricultural
Pesticides
[
40
CFR170.240(
d)(
6)].
Pilots
must
wear
the
PPE
required
on
this
labeling
for
applicators."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
(
Immediately
following
PPE
and
User
Safety
Requirements.)

User
Safety
Recommendations
"
User
Safety
Recommendations"

"
Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet."

"
Users
should
remove
clothing/
PPE
immediately
if
pesticide
gets
inside.
Then
wash
thoroughly
and
put
on
clean
clothing."

"
Users
should
remove
PPE
immediately
after
handling
this
product.
Wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing."
Precautionary
Statements
under:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)
72
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

Environmental
Hazards
"
ENVIRONMENTAL
HAZARDS"

"
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
water
mark.
Do
not
contaminate
water
when
disposing
of
equipment
washwater
or
rinsate."

"
Do
not
apply
when
weather
conditions
favor
drift
from
treated
areas.
Drift
and
runoff
from
treated
areas
may
be
hazardous
to
organisms
in
neighboring
areas."

"
This
product
may
contaminate
water
through
runoff.
This
product
has
a
high
potential
for
runoff
for
several
months
or
more
after
application.
Poorly
draining
soils
and
soils
with
shallow
water
tables
are
more
prone
to
produce
runoff
that
contains
this
product."

"
This
chemical
has
properties
and
characteristics
associated
with
chemicals
detected
in
ground
water.
The
use
of
this
chemical
in
areas
where
soils
are
permeable,
particularly
where
the
water
table
is
shallow,
may
result
in
ground
water
contamination."
Environmental
Hazards
Restricted­
Entry
Interval
(
for
labels
with
WPS
uses)

Note:
the
prohibition
for
sodfarms
may
be
dropped
if
the
end­
use
product
does
not
contain
directions
for
use
on
sodfarms
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI)
of
12
hours."

"
Harvesting
or
transplanting
turfgrass
grown
on
sodfarms
is
prohibited
for
17
days
following
application."
Directions
for
Use,

Agricultural
Use
Requirements
Box
Early
Reentry
Personal
Protective
Equipment
established
by
the
RED
(
for
labels
with
WPS
uses)
"
PPE
required
for
early
entry
to
treated
areas
that
is
permitted
under
the
Worker
Protection
Standard
and
that
involves
contact
with
anything
that
has
been
treated,
such
as
plants,
soil,
or
water,
is:

>
coveralls,

>
shoes
plus
socks,
and
>
chemical­
resistant
gloves
made
of
any
waterproof
material."
Place
in
the
Directions
for
Use
In
Agricultural
Use
Requirements
box,

immediately
following
the
REI
Entry
Restriction
for
NonWPS
uses
Entry
Restriction
for
non­
WPS
uses
applied
as
a
spray
(
does
not
include
tree­
injection
uses):

"
Do
not
enter
or
allow
others
to
enter
until
sprays
have
dried."
If
no
WPS
uses
on
the
label,
place
the
statements
in
the
Directions
for
Use
Under
General
Precautions
73
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

Entry
Restriction
for
non­
WPS
uses
applied
dry
(
does
not
include
ready­
to­
use
briquette
uses):

"
Do
not
enter
or
allow
others
to
enter
until
dusts
have
settled."

Entry
Restriction
for
non­
WPS
uses
applied
as
a
granular
and
when
watering­
in
is
required:

"
Do
not
enter
or
allow
others
to
enter
the
treated
area
(
except
those
involved
in
watering­
in)
until
watering­
in
is
complete
and
the
surface
is
dry."
and
Restrictions.

If
WPS
uses
are
also
on
the
labeling,
place
these
statements
in
a
NonAgricultural
Use
Requirements
box
as
specified
in
PR
Notice
93­

7
and
93­
11.

General
Application
Restrictions
(
for
labels
with
WPS
uses)
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application."
Place
in
the
Directions
for
Use
directly
above
the
Agricultural
Use
Box.

Other
Application
Restrictions
(
Risk
Mitigation)
All
Products/
Formulations
Containing
Triadimefon
Delete
all
directions
for
use
for
the
following
use­
patterns:

>
apples
>
grapes
>
pears
>
raspberries
>
residential
or
commercial
turfgrass
(
except
for
turfgrass
on
golf
courses
or
sodfarms).

Include
the
following
statement:
"
Application
to
trees
that
bear
fruit
or
nuts
is
prohibited.
Applications
are
permitted
on
nonbearing
fruit
or
nut
trees
only."
Directions
for
Use
Spray
Drift
"
Spray
drift
requirements"

(
1)
For
groundbloom
and
aerial
applications,
use
only
medium
or
coarser
spray
nozzles
according
to
ASABE
(
S572)
definition
for
standard
nozzles.
Aerial
applicators
must
consider
flight
speed
and
nozzle
orientation
in
determining
droplet
size.
74
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

(
2)
Make
aerial
or
ground
applications
when
the
wind
velocity
is
3
to
10
mph.
Do
not
apply
when
the
wind
speed
is
greater
than
10
mph.
For
all
non­
aerial
applications,
wind
speed
must
be
measured
adjacent
to
the
application
site
on
the
upwind
side,
immediately
prior
to
application.

(
4)
Do
not
make
aerial
or
ground
applications
into
temperature
inversions.

(
5)
For
groundboom
applications,
apply
with
nozzle
height
no
more
than
4
feet
above
the
ground
or
crop
canopy.

(
6)
For
airblast
applications,
turn
off
outward
pointing
nozzles
at
row
ends
and
when
spraying
the
outer
two
rows.
To
minimize
spray
loss
over
the
top
in
tree
applications,
spray
must
be
directed
into
the
canopy.

(
7)
For
aerial
applications,
do
not
release
spray
at
a
height
greater
than
10
feet
above
the
ground
or
plant
canopy.

(
8)
For
aerial
applications,
the
outermost
nozzles
must
not
exceed
60%
of
the
wingspan
or
80%
of
the
rotor
blade
diameter.

(
9)
When
aerial
applications
are
made
with
a
cross­
wind,
the
swath
will
be
displaced
downwind.
The
applicator
must
compensate
for
this
displacement
at
the
downwind
edge
of
the
application
area
by
adjusting
the
path
of
the
aircraft
upwind."

Application
Restrictions
for
Turfgrass
Uses
(
Note:
The
maximum
allowable
application
rate
per
application
or
per
year
must
be
listed
as
pounds
or
gallons
of
formulated
product
per
acre,
not
solely
as
pounds
active
ingredient
per
acre.)
"
Use
on
turfgrass
is
limited
to
sodfarm
turf
and
golf
course
turf
only.
Use
on
turfgrass
is
prohibited
on
all
other
residential
and
commercial
sites."

Maximum
application
rate
is
2.7
lb
ai/
A
Maximum
annual
application
rate
is
5.4
lb
ai/
A
Minimum
retreatment
interval
is
14
days.

"
Aerial
application
and
chemigation
to
turf
are
permitted
on
sodfarm
turfgrass
only."

"
Application
to
golf
courses,
including
tees,
greens,
fairways,
and
roughs,
is
permitted
only
if
the
turfgrass
is
2.5
inches
or
less
in
height."
Directions
for
Use
associated
with
turfgrass
use
directions
75
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

"
Harvesting
or
transplanting
turfgrass
grown
on
sodfarms
is
prohibited
for
17
days
following
application."

Application
Restrictions
for
Azaleas
"
Use
on
azaleas
is
limited
to
applications
to
control
pine­
twisting
rust
disease."
Directions
for
Use
associated
with
azalea
use
directions
Application
Restrictions
for
Ornamentals
and
Pine
Trees,

including
Christmas
trees
"
Chemigation
is
permitted
for
use
on
ornamentals
and
pine
trees,
including
Christmas
trees."

Application
Restrictions
for
Ornamentals
at
Residential
Sites
Note:
The
maximum
allowable
application
rate
must
be
listed
as
pounds
or
gallons
of
formulated
product
per
acre,
not
solely
as
pounds
active
ingredient
per
gallon.)
"
The
maximum
application
rate
for
ornamentals
(
including
azaleas)
at
residential
sites
is
0.0025
lb
ai/
gal."
Directions
for
Use
associated
with
ornamental
use
directions
End
Use
Products
Intended
Primarily
for
Use
by
Homeowners
Environmental
Hazards
"
ENVIRONMENTAL
HAZARDS"

"
Do
not
apply
directly
to
water.
Do
not
contaminate
water
when
disposing
of
equipment
washwaters
or
rinsate."

"
Do
not
apply
when
weather
conditions
favor
drift
from
treated
areas.
Drift
and
runoff
from
treated
areas
may
be
hazardous
to
organisms
in
neighboring
areas."

"
This
product
may
contaminate
water
through
runoff.
This
product
has
a
high
potential
for
runoff
for
Precautionary
Statements
76
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

several
months
or
more
after
application.
Poorly
draining
soils
and
soils
with
shallow
water
tables
are
more
prone
to
produce
runoff
that
contains
this
product."

"
This
chemical
has
properties
and
characteristics
associated
with
chemicals
detected
in
ground
water.
The
use
of
this
chemical
in
areas
where
soils
are
permeable,
particularly
where
the
water
table
is
shallow,
may
result
in
ground
water
contamination."

Application
Restrictions
All
products:

"
Do
not
apply
this
product
in
a
way
that
will
contact
any
person
or
pet,
either
directly
or
through
drift.

Keep
people
and
pets
out
of
the
area
during
application."
Directions
for
Use
under
General
Precautions
and
Restrictions
Statements
must
be
in
the
color
red
and
in
all
caps.

Entry
Restrictions
Products
Applied
as
a
Liquid
(
except
tree­
injection
uses):

"
Do
not
allow
people
or
pets
to
enter
the
treated
area
until
sprays
have
dried."
Directions
for
Use
under
General
Precautions
and
Restrictions
Directions
for
Use
"
Do
not
apply
this
product
to
lawns
or
other
turfgrass."
Directions
for
Use
section
Directions
for
Use
on
Ornamentals
Note:
The
maximum
allowable
application
rate
must
be
listed
as
pounds
or
gallons
of
formulated
product
per
acre,
not
solely
as
pounds
active
ingredient
per
gallon.)
"
Applications
with
hose­
end
sprayers
are
permitted
only
for
outdoor
use
on
ornamentals.
Use
of
hoseend
sprayer
equipment
in
residential
greenhouses
is
prohibited."

"
The
maximum
application
rate
for
ornamentals
is
0.0025
lb
ai/
gal."
Directions
for
Use
section
associated
with
the
directions
for
ornamental
uses
Other
Application
Restrictions
(
Risk
Mitigation)
All
Products/
Formulations
Containing
Triadimefon
Delete
all
directions
for
use
for
the
following
use­
patterns:
Directions
for
Use
77
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
NonWPS)

>
apples
>
grapes
>
pears
>
raspberries
>
residential
or
commercial
turfgrass
Include
the
following
statement:
"
Application
to
trees
that
bear
fruit
or
nuts
is
prohibited.
Applications
are
permitted
on
nonbearing
fruit
or
nut
trees
only."

1
PPE
that
is
established
on
the
basis
of
Acute
Toxicity
of
the
end­
use
product
must
be
compared
to
the
active
ingredient
PPE
in
this
document.
The
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.

2
The
registrant
must
drop
the
N
type
filter
from
the
respirator
statement
if
the
pesticide
product
contains
or
is
used
with
oil.

Instructions
in
the
Labeling
section
appearing
in
quotations
represent
the
exact
language
that
should
appear
on
the
label.

Instructions
in
the
Labeling
section
not
in
quotes
represents
actions
that
the
registrant
should
take
to
amend
their
labels
or
product
registrations.
78
VI.
Appendices
79
Appendix
A:
Use
Patterns
Subject
to
Reregistration
for
Triadimefon
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Max.
Single
Application
Rate
(
ai)
Max.
#

Apps.
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
(
Food
Uses)

Pineapples
(
post­
harvest
or
pre­
plant
crowns)

Pre­
plant
and
Post­
harvest
dip,

spray
WP
0.0028
lbs
ai/
gallon
1
Not
Specified
(
NS)
All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

(
Non­
food
Uses)

Azaleas
(
for
control
of
pine
twisting
rust,
only
Chemigation,
groundboom,

lowpressure
handwand,
high
pressure
handwand
WP
DF
0.005
lbs
ai/
gallon
8
NS
All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Christmas
trees
Aerial,
flagging,
airblast
WP
0.25
lbs
ai/
A
8
NS
A
closed
cockpit
is
required
for
aerial
applications
(
all
formulations).

All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Golf
Course
Turf
80
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Max.
Single
Application
Rate
(
ai)
Max.
#

Apps.
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
Groundboom,
LCO
handgun,

lowpressure
handwand,
and
handgun
sprayer
Flagging,
tractor­
drawn
spreader
LC
WP
DF
G
2.7
lbs
ai/
A
2
(
at
max.

single
app.

rate)
14
Use
is
restricted
to
golf
course
and
sod
farm
turf,
only.

A
maximum
annual
application
rate
of
5.4
lbs
ai/
A
is
allowed.
Applications
are
restricted
to
turf
less
than
2.5
inches
in
height.
This
applies
to
the
entire
golf
course,
including
tees,
greens,
fairways,
and
roughs.

All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Greenhouse
Ornamentals
(
including
flowers,
shrubs,
and
trees)

Low­
pressure
handwand,
handgun
sprayer,
high­
pressure
handwand
WP
LC
0.00625
lbs
ai/
gallon
0.00938
lbs
ai/
gallon
8
N/
S
NS
Prohibit
residential
(
consumer)
hose­
end
sprayer
applications
in
greenhouses.

All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Ornamentals
(
including
flowers,
shrubs
and
trees)

Low­
pressure
handwand,
handgun
sprayer,
high­
pressure
handwand
Low­
pressure
handwand,

chemigation,
groundboom,

highpressure
handwand
LC
WP
DF
0.0023
lbs
ai/
gallon
0.0025
lbs
ai/
gallon
8
NS
NS
Residential
(
consumer)
use
limited
to
ornamentals,
only.

Professional
hose­
end
sprayer
applications
are
allowed.

All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Ornamentals
(
including
shade
trees
and
woody
shrubs)
81
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Max.
Single
Application
Rate
(
ai)
Max.
#

Apps.
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
Tree
injection
unit
(
ready­
to­
use
micro
injection
unit,
or
unit
requiring
product
dilution)
LC
0.000026
lbs
ai/
inch
of
trunk
circumference
6
NS
Pines
(
including
Christmas
trees)

Low­
pressure
handwand
and
handgun
sprayer
LC
0.0023
lbs
ai/
gallon
8
NS
Pine
Seed
(
on­
nursery
applications)

Dip
Planter
box,
hopper
box,
cement
mixer,
Cement
mixer
WP
WP
DF
0.0000625
lbs
ai/
gallon
0.0013
lbs
ai/
A
0.00136
lbs
ai/
A
1
NS
NS
NS
All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Pine
Seed
(
commercial
applications)

Commercial
loading/
applying,

commercial
bagging
of
treated
seed,
commercial
bag
sewing,
and
multiple
commercial
activities
WP
0.0013
lbs
ai/
lb
1
NS
All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Pine
Seedlings
Aerial,
flagging,
airblast,

groundboom,
low­
pressure
handwand,
handgun
sprayer
By
hand
WP
Ready­
to­
use
briquette
0.5
lbs
ai/
A
0.000019
lbs
ai/
seedling
4
1
NS
NS
A
closed
cockpit
is
required
for
aerial
application.

All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Roses
82
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Max.
Single
Application
Rate
(
ai)
Max.
#

Apps.
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
Low­
pressure
handwand,
handgun
sprayer,
high­
pressure
handwand
LC
WP
0.00029
lbs
ai/
gallon
8
NS
All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.

Sod
Farm
Turf
Aerial,
chemigation,
flagging,

groundboom,
LCO
handgun,

lowpressure
handwand,
and
handgun
sprayer
Aerial,
flagging,
tractor­
drawn
spreader
WP
DF
G
2.7
lbs
ai/
A
2
(
at
max.

single
app.

rate)
17
A
closed
cockpit
is
required
for
aerial
applications
(
all
formulations).

A
maximum
annual
application
rate
of
5.4
lbs
ai/
A
is
allowed.

All
wettable
powder
products
must
be
packaged
in
water
soluble
bags.
83
Appendix
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
GUIDE
TO
APPENDIX
B
Appendix
B
contains
listing
of
data
requirements
which
support
the
reregistration
for
active
ingredients
within
the
case
2700
covered
by
this
RED/
TRED.
It
contains
generic
data
requirements
that
apply
to
triadimefon/
triadimenol
in
all
products,
including
data
requirements
for
which
a
"
typical
formulation"
is
the
test
substance.

The
data
table
is
organized
in
the
following
formats:

1.
Data
Requirement
(
Column
1).
The
data
requirements
are
listed
in
the
order
in
which
they
appear
in
40
CFR
part
158.
The
reference
numbers
accompanying
each
test
refer
to
the
test
protocols
set
in
the
Pesticide
Assessment
Guidance,
which
are
available
from
the
National
technical
Information
Service,
5285
Port
Royal
Road,
Springfield,
VA
22161
(
703)
487­
4650.

2.
Use
Pattern
(
Column
2).
This
column
indicates
the
use
patterns
for
which
the
data
requirements
apply.
The
following
letter
designations
are
used
for
the
given
use
patterns.

A.
Terrestrial
food
B.
Terrestrial
feed
C.
Terrestrial
non­
food
D.
Aquatic
food
E.
Aquatic
non­
food
outdoor
F.
Aquatic
non­
food
industrial
G.
Aquatic
non­
food
residential
H.
Greenhouse
food
I.
Greenhouse
non­
food
J.
Forestry
K.
Residential
L.
Indoor
food
M.
Indoor
non­
food
N.
Indoor
medical
O.
Indoor
residential
3.
Bibliographic
Citation
(
Column
3).
If
the
Agency
has
acceptable
data
in
its
files,
this
column
list
the
identify
number
of
each
study.
This
normally
is
the
Master
Record
Identification
(
MIRD)
number,
but
may
be
a
"
GS"
number
if
no
MRID
number
has
been
assigned.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
the
study.
84
APPENDIX
B­
1
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimefon
REQUIREMENT
USE
PATTERN
CITATION(
S)

PRODUCT
CHEMISTRY
New
Guideline
Number
Old
Guideline
Number
830.1550
61­
1
Product
Identity
and
Composition
All
CSF
('
96)

830.1600
61­
2A
Start.
Mat.
&
Mnfg.
Process
All
00098119,
42307801
830.1620
61­
2B
Description
of
Production
Process
All
00098119,
42307801
830.1650
61­
2B
Description
of
Formulation
Process
All
00098119,
42307801
830.1670
61­
2B
Formation
of
Impurities
All
40477401
830.1700
62­
1
Preliminary
Analysis
All
00098120,
44166001
830.1750
62­
2
Certification
of
limits
All
44166001,
CSF
('
96)

830.1800
62­
3
Enforcement
Analytical
Method
All
42307802
830.6302
63­
2
Color
All
41616001
830.6303
63­
3
Physical
State
All
41616001
830.6304
63­
4
Odor
All
41616001
830.6313
63­
13
Stability
to
Normal
and
Elevated
Temperatures,
Metals
and
Metal
Ions
All
42307803
830.6314
63­
14
Oxidation/
Reduction:
Chemical
Incompatibility
All
Not
Applicable;
N/
A
830.6315
63­
15
Flammability
All
N/
A
830.6316
63­
16
Explodability
All
N/
A
830.6317
63­
17
Storage
Stability
All
N/
A
830.6319
63­
19
Miscibility
All
N/
A
830.6320
63­
20
Corrosion
Characteristics
All
N/
A
830.7000
63­
12
pH
All
41616001
830.7050
None
UV/
Visable
Absorption
All
N/
A
830.7100
63­
18
Viscosity
All
41616001
85
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimefon
REQUIREMENT
USE
PATTERN
CITATION(
S)

830.7200
63­
5
Melting
Point
All
41616001
830.7220
63­
6
Boiling
Point
All
N/
A
830.7300
63­
7
Relative
Density
All
41616001
830.7370
63­
10
Dissociation
Constants
in
Water
All
N/
A
830.7550
830.7560
or
830.7570
63­
11
Octanol/
Water
Partition
Coefficient
All
42307803
830.7840
or
830.7860
63­
8
Water
solubility:
column
elution
method;
shake
flask
method
All
41616001
830.7950
63­
9
Vapor
Pressure
All
42307801
ECOLOGICAL
EFFECTS
850.2100
71­
1
Avian
Acute
Oral
Toxicity
00071469,
41895901
850.2200
71­
2A
Avian
Dietary
Toxicity
­
Quail
00071469,
00050066
850.2200
71­
2B
Avian
Dietary
Toxicity
­
Duck
00126277
850.2300
71­
4
Avian
Reproduction
 
Avian
chronic
tests
on
the
Mallard
Duck
and
Bobwhite
Quail
00110430,
00110431,
40283102,
42342301
850.2400
71­
3
Mammal
Acute/
Chronic
Toxicity­
Rat
00125411,
00151248,
00155075,
00264276,
92188019,
92188320
850.1010
72­
2A
Invertebrate
Toxicity
00071469,
00231311,
254693,
41922101
850.1025
72­
3B
Estuarine/
Marine
Toxicity
­
Mollusk
Data
Gap
850.1035
850.1045
72­
3C
Estuarine/
Marine
Toxicity
 
Shrimp
EC50
Data
Gap
850.1075
72­
3A
Estuarine/
Marine
Fish
LC50
Data
Gap
850.1075
72­
1A
Fish
Toxicity­
Bluegill
00071469,
43304301
850.1075
72­
1C
Fish
Toxicity­
Rainbow
Trout
00071469,
43256201
850.1300
72­
4A
Freshwater
Fish­
Early
Life
Stage
00251243,
41922103
86
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimefon
REQUIREMENT
USE
PATTERN
CITATION(
S)

850.1500
72­
5
Life
Cycle
Fish
N/
A
850.1735
None
Freshwater
Acute
InvertebrateToxicity
00071469,
00231311,
00246736,
41922102
850.4100
122­
1A
Terrestrial
Toxicity;
Seedling
Emergence
N/
A
850.4150
122­
1B
Terrestrial
Plant
Toxicity;
Vegetative
Vigor
N/
A
850.5400
122­
2
Aquatic
Plant
Growth
00159558,
00266051
850.4225
123­
1A
Seed
Germination
and
Seedling
Emergence
(
Tier
2)
Data
Gap
850.4250
123­
1B
Vegetative
Vigor
(
Tier
2)
Data
Gap
850.4400
123­
2
Aquatic
Vascular
Plant
Growth
(
Tier2)
Data
Gap
850.3020
141­
1
Honey
Bee
Acute
Contact
05001991,
42307804
850.3030
141­
2
Honey
Bee
Residue
on
Foliage
N/
A
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity
00125411,
00264276,
43936101
870.1200
81­
2
Acute
Dermal
Toxicity­
Rat
00145086,
00264276
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
41616002
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
41782501
870.2500
81­
5
Primary
Skin
Irritation­
Rabbit
41616004
870.2600
81­
6
Dermal
Sensitization­
Guinea
pig
41554001
870.6100
82­
5A
90­
Day
Neurotoxicity­
Hen
44153501
870.6300
83­
6
Developmental
Neurotoxicity
Study
00089023;
Data
Gap
870.3100
82­
1A
90­
Day
Feeding
­
Rat
00048624
870.3100
82­
1A
30­
Day
Oral
Toxicity­
Rat
00048627
870.3150
82­
1B
90­
Day
Feeding
(
Non­
rodent)­
Dog
00048625,
00060226
870.3200
82­
2
21­
Day
Dermal
Toxicity­
Rat
42341501
870.3700
83­
3A
Developmental
Toxicity
­
Rat
00089023,
00149336,
92188018
87
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimefon
REQUIREMENT
USE
PATTERN
CITATION(
S)

870.3700
83­
3B
Developmental
Toxicity
­
Rabbit
41446201,
42089601
870.3800
83­
4
2­
Generation
Reproduction
­
Rat
00155075,
92188019,
92188020
The
reproductive
study
in
the
rat
is
acceptable/
nonguideline
in
conjunction
with
the
3­
generation
study
(
MRID
00032541)

870.3800
83­
4
Reproduction
and
fertility
effects
(
3­
Gen)­
Rat
00032541
The
reproductive
study
in
the
rat
is
acceptable/
nonguideline
in
conjunction
with
the
multi­
generation
reproduction
study
(
MRID
00155075)

870.4100
83­
1B
Chronic
Toxicity
­
Dog
00032539,
00126261
870.4200
83­
2B
Carcinogenicity­
Mice
40752101,
40865101
870.4300
83­
5
2­
year
Combined
Chronic/
Oncogenicty­
Rat
42153901
870.5100
84­
2
Mutagenicity­
Gene
Mutation­
bacterial
00126264,
00099413
870.5395
84­
2
Micronuleus
Assay
00048637
870.5450
84­
2
Cytogenetics
Dominant
Lethal
Assay
00048628
870.5550
84­
2
Unscheduled
DNA
Synthesis
Assay
00159343
870.6200
81­
8
Acute
Neurotoxicity
Screening
Battery­
Rat
43495509,
43936101
870.6200
82­
7
Subchronic
Neurotoxicity
Screening
Battery­
Rat
44153501
870.7485
85­
1
General
Metabolism­
Rat
00033057,
42409101
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2400
133­
3
Dermal
Passive
Dosimetry
Exposure
43125401
875.2500
133­
4
Inhalation
Passive
Dosimetry
Exposure
43125401
None
231
Estimation
of
Dermal
Exposure
at
Outdoor
Sites
45654503
88
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimefon
REQUIREMENT
USE
PATTERN
CITATION(
S)

None
232
Estimation
of
Inhalation
Exposure
at
Outdoor
Sites
45654503
ENVIRONMENTAL
FATE
None
160­
5
Chemical
Identity
N/
A
835.2120
161­
1
Hydrolysis
41922101
835.2240
161­
2
Photodegradation
­
Water
42112901
835.2410
161­
3
Photodegradation
­
Soil
00044169,
42820401
835.2370
161­
4
Photodegradation
­
Air
N/
A
835.4100
162­
1
Aerobic
Soil
Metabolism
42242701,
42224104,
41686102,

835.4200
162­
2
Anaerobic
Soil
Metabolism
41686101,
42401201
835.4400
162­
3
Anaerobic
Aquatic
Metabolism
41686101,
42401201
835.4300
162­
4
Aerobic
Aquatic
Metabolism
42224104
835.1240
163­
1
Leaching/
Adsorption/
Desorption
41616008,
42356601
835.1410
163­
2
Laboratory
Volatilization
N/
A
835.8100
163­
3
Volatility­
Field
N/
A
835.6100
164­
1
Terrestrial
Field
Dissipation
42242701,
41686103,
41686104
835.6200
164­
2
Aquatic
Field
Dissipation
N/
A
835.6300
164­
3
Forestry
Dissipation
N/
A
860.1950
165­
4
Bioaccumulation
in
Fish
41619901
None
165­
5
Bioaccumulation­
Aquatic
Nontarget
41619901
835­
7100
166­
1
Ground
Water­
Small
Scale
Prospective
N/
A
840.1100
201­
1
Spray
Droplet
Size
Spectrum
N/
A
840.1000
201­
4
Background
for
Pesticide
Aerial
Drift
(
Evaluation)
N/
A
840.1200
202­
1
Spray
Drift
Field
Deposition
(
Evaluation)
N/
A
RESIDUE
CHEMISTRY
89
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimefon
REQUIREMENT
USE
PATTERN
CITATION(
S)

860.1200
171­
3
Directions
for
Use
N/
A
860.1300
171­
4A
Nature
of
Residue
­
Plants
42123401,
42123402,
42123403,
42798901,
42853401,
92188025­
33
860.1300
171­
4B
Nature
of
Residue
­
Livestock
42123404,
42856801,
42864901,
43418301­
02,
92188034­
39
860.1340
171­
4C
Residue
Analytical
Method
­
Plants
43870101,
44041002,
92188040­
43
860.1340
171­
4D
Residue
Analytical
Method
­
Livestock
43418303,
92188044­
48
860.1360
171­
4M
Multiresidue
Methods
41976601,
43705401
860.1380
171­
4E
Storage
Stability
Data­
Plant
and
Livestock
41976602,
42857401,
44038901,
44041001,
92188051­
53,
43462401
860.1480
171­
4J
Magnitude
of
Residues
­
Meat/
Milk/
Poultry
/
Egg
92188054­
57
860.1500
171­
4K
Crop
Field
Trials
92188060­
65,
92188070,
92188073­
75,
42342303­
08,
41809401
860.1520
171­
4L
Magnitude
of
Residue
in
Processed
Food/
Feed
42346601,
43948601,
92188064­
65,
92188069,
43284401,
42013201,
92188074
860.1850
165­
1
Confined
Accumulation
in
Rotational
Crops
Study
42613301
860.1900
165­
2
Field
Accumulation
in
Rotational
Crops
Study
N/
A
90
APPENDIX
B­
2
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimenol
REQUIREMENT
USE
PATTERN
CITATION(
S)

PRODUCT
CHEMISTRY
New
Guideline
Number
Old
Guideline
Number
830.1550
61­
1
Product
Identity
and
Composition
All
N/
A
830.1600
61­
2A
Start.
Mat.
&
Mnfg.
Process
All
N/
A
830.1620
61­
2B
Description
of
Production
Process
All
N/
A
830.1650
61­
2B
Description
of
Formulation
Process
All
N/
A
830.1670
61­
2B
Formation
of
Impurities
All
N/
A
830.1700
62­
1
Preliminary
Analysis
All
N/
A
830.1750
62­
2
Certification
of
limits
All
N/
A
830.1800
62­
3
Enforcement
Analytical
Method
All
N/
A
830.6302
63­
2
Color
All
N/
A
830.6303
63­
3
Physical
State
All
N/
A
830.6304
63­
4
Odor
All
N/
A
830.6313
63­
13
Stability
to
Normal
and
Elevated
Temperatures,
Metals
and
Metal
Ions
All
Data
Gap
830.6314
63­
14
Oxidation/
Reduction:
Chemical
Incompatibility
All
N/
A
830.6315
63­
15
Flammability
All
N/
A
830.6316
63­
16
Explodability
All
N/
A
830.6317
63­
17
Storage
Stability
All
N/
A
830.6319
63­
19
Miscibility
All
N/
A
830.6320
63­
20
Corrosion
Characteristics
All
N/
A
830.7000
63­
12
pH
All
Not
available;
Data
Gap
830.7050
None
UV/
Visable
Absorption
All
Not
Available;
Data
Gap
830.7100
63­
18
Viscosity
All
N/
A
91
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimenol
REQUIREMENT
USE
PATTERN
CITATION(
S)

830.7200
63­
5
Melting
Point
All
00125399
830.7220
63­
6
Boiling
Point
All
N/
A
830.7300
63­
7
Relative
Density
All
00125399
830.7370
63­
10
Dissociation
Constants
in
Water
All
Not
available
830.7550
830.7560
or
830.7570
63­
11
Octanol/
Water
Partition
Coefficient
All
Not
available;
Data
Gap
830.7840
or
830.7860
63­
8
Water
solubility:
column
elution
method;
shake
flask
method
All
00125399;
Data
Gap
830.7950
63­
9
Vapor
Pressure
All
00125399
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity
00125411
870.1200
81­
2
Acute
Dermal
Toxicity­
Rat
00145086
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
00145087
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
00145088
870.2500
81­
5
Primary
Skin
Irritation­
Rabbit
00145088
870.2600
81­
6
Dermal
Sensitization­
Guinea
pig
00125413
870.3100
82­
1A
90­
Day
Oral
Toxicity­
Rat
00127769,
42192701
870.3150
82­
1B
90­
Day
Oral
Toxicity
(
Non­
rodent
)­
Dog
00125420
870.3150
82­
1B
6
months
oral
toxicity
(
Non­
rodent)­
Dog
00151247
870.3200
82­
2
15­
Day
Dermal
Toxicity­
Rabbit
00151246
870.3465
82­
4
21­
Day
Inhalation
Toxicity­
Rat
00125421
870.3700
83­
3A
Prenatal
Developmental
Toxicity
­
Rat
40307804,
40887702,
41498401
870.3700
83­
3B
Developmental
Toxicity
­
Rabbit
40307805,
40887703,
42365001
92
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimenol
REQUIREMENT
USE
PATTERN
CITATION(
S)

870.3800
83­
4
2­
Gen.
reproduction
and
fertility
effects
­
Rat
00151248
870.4100
83­
1B
Chronic
Toxicity
­
Dog
00150484,
00159012
870.4200
83­
2B
Carcinogenicity­
Mice
00126259,
44740901
870.4300
83­
5
Combined
Chronic/
Carcinogenicity­
Rat
00126260
870.5100
84­
2
Bacterial
system,
mammalian
activation­
Gene
Mutation
00126264
870.5300
84­
2
In
Vitro
Mammalian
Cell
Gene
Mutation
00126269
870.5450
84­
2
Cytogenetics
Dominant
Lethal
Assay
00126266
870.5500
84­
2
Other
Genotoxicity
DNA
Damage
00126271
870.5550
84­
2
Other
Genotoxicity
Unscheduled
DNA
Synthesis
00126271
870.5900
84­
2
Other
Effects
In
Vitro
Sister
Chromatid
Exchange
Assay
40815901
870.6100
81­
7
Acute
Neurotoxicity
Study
Data
Gap
870.6200
82­
7
Subchronic
Neurotoxicity
Study
Data
Gap
Other
none
Other
Studies;
Central
Nervous
Effects­
Mice
00145083
RESIDUE
CHEMISTRY
860.1200
171­
3
Directions
for
Use
N/
A
860.1300
171­
4A
Nature
of
Residue
­
Plants
42123401­
03,
42798901,
42853401,
92188025­
33
860.1300
171­
4B
Nature
of
Residue
­
Livestock
42123404,
42856801,
42864901,
43418301­
02,
92188034­
39
860.1340
171­
4C
Residue
Analytical
Method
­
Plants
43870101,
44041002,
92188040­
43
860.1340
171­
4D
Residue
Analytical
Method
­
Livestock
43418303,
92188044­
48
860.1360
171­
4M
Multiresidue
Methods
40969801,
41976601,
43705401
93
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Triadimenol
REQUIREMENT
USE
PATTERN
CITATION(
S)

860.1380
171­
4E
Storage
Stability
Data­
Plant
and
Livestock
41976602,
42857401,
44038901,
44041001,
92188051­
53,
43462401
860.1480
171­
4J
Magnitude
of
Residues
­
Meat/
Milk/
Poultry
/
Egg
92188054­
57
860.1500
171­
4K
Crop
Field
Trials
00125407­
09,
40615201,
41051401,
41242801,
42696308­
09,
42712101
860.1520
171­
4L
Magnitude
of
Residue
in
Processed
Food/
Feed
44519801­
03
860.1850
165­
1
Confined
Accumulation
in
Rotational
Crops
Study
42613301
860.1900
165­
2
Field
Accumulation
in
Rotational
Crops
Study
N/
A
94
Appendix
C.
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
Room
119,
Crystal
Mall
#
2,
1801
South
Bell
Street,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
Federal
Holidays,
from
8:
30
am
to
4
pm.

The
docket
contains
the
risk
assessments
and
related
documents
as
of
August
30,
2006.
The
availability
announcement
will
be
published
in
the
Federal
Register.
All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
internet
at
the
following
site:
www.
epa.
gov/
pesticides/
reregistration.
The
following
list
details
all
documents
related
to
the
Triadimefon/
Triadimenol
(
RED/
TRED).

Health
Effects
Documents:

1.
DP
Barcode
329823
and
D328572.
Jin
Kim,
Tara
Chandgoyal
and
Jonathan
Becker.
July
18,
2006.
Characterization
of
Triadimefon
Use
on
Golf
Courses,
Turf,
Pine
Seed
and
Seedling
Treatment,
and
Pineapple.

2.
DP
Barcode
D314778.
Yvonne
Barnes
and
Sheila
Piper.
July
6,
2006.
Triadimefon:
Revised
Acute,
Probabilistic
and
Chronic
Dietary
(
Food
+
Drinking
Water)
Exposure
and
Risk
Assessments
for
the
Triadimefon
Reregistration.

3.
DP
Barcode
D331455.
Yvonne
Barnes
and
Sheila
Piper.
August
1,
2006.
Triadimefon
+
Triadimenol:
Aggregate
Acute,
Chronic,
and
Short­
Term
Risk
Assessments
Reflecting
July,
2006
Risk
Mitigation
in
Response
to
the
Phase
4
Triadimefon
RED.

5.
DP
Barcode
D328262.
Rich
Griffin.
June
20,
2006.
Triadimefon:
HED
Response
to
Comments
Received
During
the
Public
Comment
Phase.

6.
DP
Barcode
D330611.
Rich
Griffin.
July
10,
2006.
Triadimefon/
Triadimenol:
Summary
of
Refinements
and
Revisions
to
the
Human
Health
Risk
Assessment.

7.
DP
Barcode
D314814
and
D315040.
Shanna
Recore.
June
30,
2006.
Triadimefon:
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document.

8.
Meeting
Summary.
Kimberly
Nesci.
EPA/
FDA
Joint
Teleconfernce
on
July
11,
2006
to
Discuss
1,2,4
Triazole
(
Free
Triazole)
as
a
Common
Metabolite
of
Triazole
Derivative
Fungicides
and
Anastrozole,
a
Drug.

9.
Sam
Ary.
Triadimefon.
Acute
and
Chronic
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
95
10.
DP
Barcode
D321636.
Sam
Ary.
August
31,
2005.
Triadimefon.
Registrants
Response
to
Residue
Chemistry
Data
Requirements.
Magnitude
of
Triadimefon
Residues
of
Concern
in
Apple
Processed
Commodities.

11.
DP
Barcode
D314778.
Sam
Ary.
November
23,
2005.
Triadimefon.
Acute
and
Chronic
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.

12.
DP
Barcode
D315115.
Yvonne
Barnes.
November
22,
2005.
Triadimefon:
Summary
of
Product
Chemistry
Data
for
Reregistration
Eligibility
Decision
(
RED)
Document.

13.
DP
Barcode
D
326678.
Rich
Griffin.
February
9,
2006.
Triadimefon.
Preliminary
Human
Health
Risk
Assessment
(
Revised).

14.
DP
Barcode
D314742.
Sam
Ary.
November
23,
2005.
Triadimefon.
Summary
of
Analytical
Chemistry
and
Residue
Data
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.

15.
DP
Barcode
D314928.
Sam
Ary.
November
18,
2005.
Triadimenol
Acute
and
Chronic
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Eligibility
Decision
Document.

16.
DP
Barcode
D314891.
Sam
Ary.
November
17,
2005.
Triadimenol.
Summary
of
Analytical
Chemistry
and
Residue
Data
for
the
Tolerance
Reassessment
Eligibility
Decision
Document.

17.
DP
Barcode
D326716.
Christina
Jarvis.
January
24,
2006.
Triadimenol
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
(
Revised).

18.
DP
Barcode
D322336.
Sam
Ary.
October
14,
2005.
Triadimenol.
Registrants
Response
to
Residue
Chemistry
Data
Requirements.

19.
DP
Barcode
D315152.
Yvonne
Barnes.
November
22,
2005.
Summary
of
Product
Chemistry
Data
for
Tolerance
Reassessment
Document.

20.
DP
Barcode
D322240.
Jack
Arthur.
December
9,
2005.
Occupational
and
Residential
Exposure/
Risk
Assessment
of
1,2,4­
Triazole.

21.
DP
Barcode
D
322238.
Michael
Doherty.
November
1,
2005.
1,2,4­
Triazole.
Acute
and
Chronic
Dietary
Exposure
Assessments
to
Support
Reregistration
and
Registration
Actions
for
Triazole­
derivative
Fungicides.
96
22.
DP
Barcode
D322239.
Michael
Doherty.
December
20,
2005.
Triazole
Alanine
and
Triazole
Acetic
Acid.
Acute
and
Chronic
Dietary
Exposure
Assessments
to
Support
Reregistration
and
Registration
Actions
for
Triazolederivative
Fungicides.

23.
DP
Barcode
D322215.
Michael
Doherty.
February
7,
2006.
1,2,4­
Triazole,
Triazole
Alanine,
triazole
Acetic
Acid:
Human
Health
Aggregate
Risk
Assessment
in
Support
of
Reregistration
and
Registration
Actions
for
Triazole­
derivative
Fungicide
Compounds.

24.
Kathleen
Raffaele.
Triazoles­
2nd
Report
of
the
Ad
Hoc
HED
Peer
Review
Committee.

Ecological
Fate
and
Effects
Documents:

1.
DP
Barcode
D328531.
Fred
Jenkins
and
Jonathan
Angier.
June
1,
2006.
Response
to
Bayer
Public
Comments
Regarding
the
Environmental
Fate
and
Effects
Division
Triadimefon
Risk
Assessment.

2.
DP
Barcode
D
331725.
Fred
Jenkins
and
Jonathan
Angier.
August
3,
2006.
EFED
Revisions
to
the
Ecological
Risk
Assessment
(
dated
Aug.
30,
2005)
and
the
Drinking
Water
Exposure
Assessment
(
dated
Aug.
31,
2005)
in
Support
of
the
Triadimefon
Reregistration
Eligibility
Decision
Document.

3.
DP
Barcode
D316941.
Jonathan
Angier.
August
31,
2005.
Tier
2
Drinking
Water
Assessment
for
Triadimefon
and
its
Major
Degradate
Triadimenol.

4.
Jonathan
Angier
and
Michelle
Embry.
January
19,
2006.
Environmental
Fate
and
Ecological
Risk
Assessment
for
Triadimefon.

5.
DP
Barcode
D312519.
James
Breithaupt.
February
9,
2005.
TRED
for
Triadimenol;
Drinking
Water
Assessment.

6.
DP
Barcode
D329271.
James
Hetrick.
June
15,
2006.
Response
to
Triazole
Task
Force
Comments
on
the
FQPA
Drinking
Water
Assessment
for
1,2,4­
Triazole
(
1,2,4­
T),
Triazole
alanine
(
TA),
and
Triazole
acetic
acid
(
TAA).

Other
Documents:

1.
Memorandum.
John
A.
Lazor.
EPA
1,2,4
Triazole
Consult
Response.
97
Appendix
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
Reregistration
Eligibility
Decision
(
Bibliography)
for
Triadimefon
and
Triadimenol
Bibliography
MRID
Citation
Reference
32539
Hoffman,
K.;
Groning,
P.
(
1978)
Meb
6447
Long­
Term
Toxicity
Study
on
Dogs
(
Two­
Year
Feeding
Study):
Report
No.
7882;
Report
No.
66656.
(
Unpublished
study
received
Apr
28,
1980
under
3125­
318;
prepared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
099413­
D)

32541
Loser,
E.;
Lorke,
D.
(
1979)
Meb
6447
Multigeneration
Reproduction
Study
on
Rats:
Report
No.
8297;
Report
No.
67752.
(
Unpublished
study
received
Apr
28,
1980
under
3125­
318;
prepared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
099413­
F)

33057
Fredrickson,
D.
R.
(
1978)
Metabolism
of
Bayleton^(
TM)
I
in
Rats:
Re­
port
No.
66201.
(
Unpublished
study
received
Apr
28,
1980
under
3125­
318;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
099415­
F)

48624
Mohr,
U.
(
1976)
Meb
6447:
Subchronic
Toxicity
Study
on
Rats
(
Twelve
­
Week
Feeding
Experiment):
Report
No.
R
840
a;
Report
No.
44300.
(
Unpublished
study
received
Aug
15,
1977
under
3125­
318;
pre­
pared
by
Medizinische
Hochschule
Hannover,
Abteilung
fur
Experi­
mentelle
Pathologie,
West
Germany,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
231312­
C)

48625
Hoffman,
K.;
Luckhaus,
G.
(
1974)
Meb
6447:
Subchronic
Toxicity
Study
on
Dogs
(
Thirteen­
Week
Feeding
Experiment):
Report
No.
5071;
Report
No.
44737.
(
Unpublished
study
received
Aug
15,
1977
under
3125­
318;
prepared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
231312­
D)

48627
Thyssen,
J.;
Kimmerle,
G.;
Luckhaus,
G.
(
1974)
Meb
6447:
Subacute
Toxicity
Studies:
Report
No.
4464;
Report
No.
46338.
(
Unpub­
lished
study
received
Aug
15,
1977
under
3125­
318;
prepared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.;
Kansas
City,
Mo.;
CDL:
231312­
F)

48628
Machemer,
L.
(
1976)
Meb
6447:
Dominant
Lethal
Study
on
Male
Mice
to
Test
for
Mutagenic
Effects:
Report
No.
5837;
Report
No.
47929.
(
Unpublished
study
received
Aug
15,
1977
under
3125­
318;
pre­
pared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
231312­
G)

48637
Machemer,
L.
(
1977)
MEB
6447
(
Triadimefon,
Bayleton
Active
Ingre­
dient):
Micronucleus
Test
on
Mice
to
Evaluate
Meb
6447
for
Muta­
genic
Effects:
Report
No.
6622;
Report
No.
52724.
(
Unpublished
study
received
Aug
15,
1977
under
3125­
318;
prepared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
231312­
P)

50066
Fink,
R.;
Beavers,
J.
B.
(
1977)
Final
Report:
Eight­
Day
Dietary
LC50­­
Bobwhite
Quail:
Project
No.
149­
105;
Report
No.
527773.
(
Unpublished
study
received
Aug
15,
1977
under
3125­
318;
pre­
pared
by
Wildlife
International,
Ltd.,
submitted
by
Mobay
Chemi­
cal
Corp.,
Kansas
City,
Mo.;
CDL:
231311­
K)
98
MRID
Citation
Reference
60226
Hoffmann,
K.;
Luckhaus,
G.;
Lorke,
D.
(
1974)
Meb
6447:
Subchronic
Toxicity
Study
on
Dogs
(
Thirteen­
Week
Feeding
Experiment):
Re­
port
No.
5071;
Report
No.
44737.
(
Unpublished
study
received
Dec
15,
1977
under
3125­
EX­
149;
prepared
by
Bayer,
AG,
W.
Germany,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
232490­
D)

71469
Mobay
Chemical
Corporation
Agricultural
Chemicals
Division;
Environmental
Toxicology
of
Baytan
(
Triadimenol);
KWG
0519;
October
29,
1982.

89023
Nagumo,
K.;
Teraki,
Y.;
Chiba,
T.;
et
al.
(
1981)
Teratogenicity
Test
of
MEB
6447
in
Pregnant
Rats:
?
Submitter|
80257.
(
Unpub­
lished
study
received
Jan
5,
1982
under
1F2474;
prepared
by
St.
Marianna
Univ.,
First
Dept.
of
Anatomy,
Laboratory
of
Embry­
ology,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
070570­
A)

98119
Smith,
D.
N.
(
1981)
Bayleton
Manufacture.
(
Unpublished
study
re­
ceived
Mar
30,
1982
under
2F2665;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
070747­
A)

98120
Harbin,
D.
N.;
Slahck,
S.
C.;
Westphal,
C.
(
1982)
The
Composition
of
Technical
^(
R)
IBayleton:
Report
No.
80605.
(
Unpublished
study
received
Mar
30,
1982
under
2F2665;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
070747­
B)

110430
Mobay
Chemical
Corp.
(
1982)
Synopsis
of
Environmental
Toxicology
of
Bayleton.
Summary
of
studies
248117­
B
through
248117­
E.
(
Unpublished
study
received
Aug
17,
1982
under
3125­
318;
CDL:
248117­
A)

110431
Lamb,
D.;
Carsel,
M.;
Mallicoat,
D.;
et
al.
(
1982)
Triadimefon
(
Bayleton)
Reproduction
Study
with
Bobwhite
Quail:
Study
No.
81­
675­
03;
80753.
(
Unpublished
study
received
Aug
17,
1982
under
3125­
318;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
248117­
B)

125399
Mobay
Chemical
Corp.
(
1983)
Product
Chemistry
of
Baytan.
(
Compi­
lation;
unpublished
study
received
Mar
11,
1983
under
3125­
346;
CDL:
071461­
A)

125411
Mihail,
F.;
Thyssen,
J.;
Lorke,
D.
(
1980)
KWG
0519
(
Triadimenol):
Acute
Toxicity
Studies­
­(
Isomer
Ratio
80:
20):
Bayer
Report
No.
9451;
69378.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Farbenfabriken
Bayer,
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071466­
B)

125421
Kimmerle,
G.;
Lorke,
D.
(
1976)
KWG
0519:
Subacute
Inhalation
Toxicity
Study
on
Rats:
Report
No.
6321;
51130.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Farben­
fabriken
Bayer,
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071466­
M)

126259
Bomhard,
E.;
Loser,
E.;
Frank;
et
al.
(
1982)
KWG
0519
(
Triadimenol,
Baytan
Active
Ingredient):
Chronic
Toxicological
Study
on
Mice
(
Feeding
Experiment
over
Two
Years):
Report
No.
10855­
82291.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Farbenfabriken
Bayer,
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071467­
A)

126260
Kroetlinger,
F.;
Loeser,
E.;
Schilde,
B.;
et
al.
(
1982)
KWG
0519:
(
Triadimenol,
the
Active
Ingredient
of
Baytan):
Chronic
Toxicity
Study
on
Rats
(
2­
year
Feeding
Experiment):
Bayer
Report
No.
11009;
82358.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
99
MRID
Citation
Reference
prepared
by
Bayer
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071468­
A)

126261
Hoffmann,
K.;
Groning,
P.;
Lorke,
D.
(
1978)
MEB
6447:
Long­
term
Toxicity
Study
on
Dogs
(
Two­
year
Feeding
Study):
Report
No.
7882;
66656.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Bayer
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071468­
B)

126264
Herbold,
B.;
Lorke,
D.
(
1979)
KWG
0519:
Salmonella/
Microsome
Test
for
Detection
of
Point­
mutagenic
Effects:
Report
No.
8189;
67595.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Bayer
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071468­
F)

126266
Herbold,
B.;
Lorke,
D.
(
1978)
KWG
0519:
Dominant
Lethal
Study
on
Male
Mouse
to
Test
for
Mutagenic
Effects:
Report
No.
7900;
66746.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Bayer
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071468­
H)

126269
Cifone,
M.;
Balinas,
V.
(
1982)
Mutagenicity
Evaluation
of
KWG
0519
in
the
Mouse
Lymphoma
Forward­
mutation
Assay:
LBI
Safety
No.
7607;
82353.
Final
rept.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Litton
Bionetics,
Inc.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071468­
K)

126271
Herbold,
B.;
Lorke,
D.
(
1981)
KWG
0519:
Triadimenol,
the
Active
Ingredient
of
Baytan:
Study
of
DNA
Damage
Using
the
E.
coli
Pol
Al­
Test:
Bayer
Report
No.
10265;
80212.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
prepared
by
Bayer
AG,
W.
Ger.,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071468­
M)

126277
Lamb,
D.;
Toll,
P.;
Mallicoat,
D.;
et
al.
(
1981)
Acute
Dietary
LC50
of
Technical
Triadimenol
(
Baytan)
to
Mallard
Ducks
and
Bobwhite
Quail:
Study
No.
80­
175­
09
and
80­
175­
05.
(
Unpublished
study
received
Mar
11,
1983
under
3125­
346;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
MO;
CDL:
071469­
F)

145083
Polacek,
I.
(
1983)
Central
Nervous
Effects
of
KWG
0519
(
Pilot
Study):
Study
No.
03018.
Unpublished
study
prepared
by
Toxicol­
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Institute
Regensburg.
17
p.

145086
Hixson,
E.
(
1983)
Acute
Dermal
Toxicity
of
Baytan
25%
Dry
Flowable
in
Rabbits:
Study
Number
83­
023­
05.
Unpublished
study
prepared
by
Mobay
Chemical
Corporation.
11
p.

145087
Sangha,
G.
(
1983)
Acute
Inhalation
Toxicity
Study
with
Baytan
25%
Dry
Flowable
in
Rats:
Study
Number
83­
041­
08.
Unpublished
study
prepared
by
Mobay
Chemical
Corporation.
16
p.

145088
Hixson,
E.
(
1984)
Eye
and
Dermal
Irritation
of
Baytan
25%
Dry
Flowable
in
Rabbits:
Study
Numbers
83­
323­
06
and
83­
333­
06.
Unpublished
study
prepared
by
Mobay
Chemical
Corporation.
16
p.

149331
Mihail,
F.
(
1980)
MEB
6447:
Acute
Toxicity
Studies:
Report
No.
9277.
Unpublished
study
prepared
by
Bayer
AG.
10
p.
100
MRID
Citation
Reference
149336
Unger,
T.;
Van
Goethem,
D.;
Shellenberger,
T.
(
1982)
A
Terato­
logical
Evaluation
of
Bayleton
in
Mated
Female
Rats:
MRI
Project
No.
7272­
B.
Unpublished
study
prepared
by
Midwest
Research
Institute.
52
p.

150484
Hoffmann,
K.;
Vogel,
O.
(
1984)
KWG
0519
(
C.
N.
Triadimenol)
First
Chronic
Study
of
Toxicity
to
Dogs
on
Oral
Administration
(
Two­
year
Feeding
Study):
KWG
0519/
005.
Unpublished
study
prepared
by
Bayer
AG.
254
p.

151246
Heimann,
K.;
Schilde,
B.
(
1984)
KWG
0519
(
Suggested
Common
Name:
Triadimenol,
the
Active
Ingredient
of
BAYTAN):
Subacute
Dermal
Toxicity
Study
on
Rabbits:
Bayer
Report
No.:
12496.
Unpublished
study
prepared
by
Bayer
AG.
66
p.

151247
Hoffmann,
K.
(
1984)
KWG
0519
(
c.
n.
Triadimenol):
Second
Chronic
Study
of
Toxicity
to
Dogs
on
Oral
Administration
(
Six­
month
Feeding
Study):
Report
No.:
12971.
Unpublished
study
prepared
by
Bayer
AG.
127
p.

151248
Loeser,
E.;
Eiben,
R.
(
1984)
KWG
0519
(
Proposed
c.
n.
Triadimenol):
Generation
Study
on
Rats:
Report
No.:
12390.
Unpublished
study
prepared
by
Bayer
AG.
250
p.

155075
Eiben,
R.
(
1984)
MEB
6447
(
Triadimefon):
Two­
generation
Study
with
Rats:
Supplementary
Study:
Report
No.
12712.
Unpublished
study
prepared
by
Bayer
AG,
Institute
of
Toxicology.
168
p.

159012
Hoffmann,
K.
(
1984)
Investigation
of
the
Body
Weight
Development
of
Beagle
Dogs
in
Chronic
Toxicity
Studies
(
Survey,
1973­
1983):
Pharma
Report
No.
12385.
Unpublished
study
prepared
by
Bayer
Pharmaceuticals
Div.
14
p.

159343
Herbold,
B.
(
1985)
MEB
6447
C.
N.
Triadimefon:
Pol
Test
on
E.
coli
To
Evaluate
for
Potential
DNA
Damage:
Revised
Report:
Report
No.
12780.
Unpublished
translation,
Mobay
report
no.
86793,
of
study
prepared
by
Bayer
AG.
16
p.

159558
Heimbach,
F.
(
1985)
Growth
Inhibition
of
Green
Algae
(
Scenedesmus
subspicatus)
by
Triadimefon
(
Technical):
Test
Report:
Report
HBF/
A112:
Study
No.
A105/
85.
Unpublished
study
prepared
by
Bayer
AG.
18
p.

231311
Chemagro
Agricultural
Division,
Bayleton
Fish
and
Wildlife
Safety,
June,
18
1977.

246736
Mobay
Chemical
Corporation,
Corporate
Toxicology
Department,
Stanley
Life
Cycle
Study
of
Triadimefon
to
Daphnia
Magna;
Research
Center;
Study
Number
81­­
667­
01
Author:
D.
W.
Lang.

251243
Mobay
Chemical
Corporation,
Toxicity
of
Triadimefon
(
Bayleton)
To
Rainbow
Trout
Early
Life
Stages;
Report
No.
85939
September
9,
1983.

254693
Mobay
Chemical
Corporation,
Bayleton
Fish
and
Wildlife
Data,
Brochure,
confidential
document
number
AS
84­
2461;
September,
1984.

264276
Mobay
Corporation
Environmental
Health
Research;
Toxicology
of
Bayleton;
Supplement
No.
5
to
Original
Brochure
Date
June
6,
1977;
Brochure
No.
1441;
February
21,
1986.

5001991
Stevenson,
J.
H.;
The
Acute
Toxicity
of
Unformulated
Pesticides
to
Worker
Honey
Bees;
Rothamsted
Experimental
Station
Harpenden
New
Hampshire.
101
MRID
Citation
Reference
40283102
Mobay
Corporation
Coroporate
Toxicology
Department;
Effect
of
Triadimenol
(
Baytan)
of
Mallard
Duck
Reproduction;
Report
No.
86385;
February
28,
1984;
Report
Author:
J.
C.
Carlisle.

40307804
Becker,
H.
(
1987)
Embryotoxicity
(
including
Teratogenicity)
Study
with
KWG
0519
in
the
Rat:
Report
No.
94463.
Unpublished
compil­
ation
prepared
by
Research
and
Consulting
Co.
AG.
494
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40307805
Becker,
H.;
Mueller,
E.;
Vogel,
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al.
(
1987)
Embryotoxicity
(
including
Teratoegenicity)
Study
with
KWG
0519
in
the
Rabbit:
Project
065248:
Report
No.
94762.
Unpublished
compilation
pre­
pared
by
Research
and
Consulting
Co.
AG.
318
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40477401
Talbott,
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(
1987)
Supplement
1:
Product
Chemistry
of
Bayleton
Technical:
Laboratory
Project
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ANR­
00587.
Unpublished
study
prepared
by
Mobay
Corporation.
55
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40615201
Pither,
K.
(
1988)
Triadimenol­­
Magnitude
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Residues
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Bananas:
Baytan
Objective
No.
5781.
Unpublished
study
prepared
by
PTRL.
86
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40752101
Bomhard,
E.
(
1986)
MEB
6447:
Carcinogenicity
Study
on
NMRI
Mice
(
21­
Month
Administration
in
the
Feed):
Report
No.
87287.
Unpu­
blished
study
prepared
by
Bayer
AG.
1190
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40819101
Nagata,
T.
(
1981)
Triadimefon
Subacute
Toxicity
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Rats:
3­
Month
Feeding
Study:
Report
No.
69700.
Unpublished
study
prepared
by
Shin
Nippon
Kagaku
Co.,
Ltd.
229
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40865101
Bombard,
E.;
Hahnemann,
S.
(
1986)
MEB
6447:
Common
Name:
Triadime­
fon,
the
Active
Ingredient
of
Bayleton:
Carcinogenicity
Study
on
NMRI
Mice:
Project
ID
87287.
Unpublished
study
prepared
by
Bayer
Ag.
5
p.

40887702
Becker,
H.
(
1987)
Embryotoxicity
(
Including
Teratogenicity)
Study
with
KWG
0519
in
the
Rat:
Project
ID
94463.
Unpublished
study
prepared
by
Research
and
Consulting
Co.
13
p.

40887703
Becker,
H.
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Talbot,
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41616002
Warren,
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Acute
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042­
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Un­
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41616004
Sheets,
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Primary
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90­
325­
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Daly,
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50
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41619901
Grau,
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Triadimefon:
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55
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41686101
Leimkuehler,
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The
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?
Triazole­
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41686102
Leimkuehler,
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carbon
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42
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41686103
Carey,
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44
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41686104
Carey,
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Subsurface
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72
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41782501
Sheets,
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1990)
Primary
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50%
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Lab
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335­
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41809401
Williams,
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Technical
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41922101
Cain,
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Gagliano,
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Chronic
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Cohle,
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Early
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Fathead
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promelas)
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Flow­
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Ver
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Clemens,
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Teratology
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Krolski,
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carbon
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Minor,
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Duah,
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The
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BL830089R0A:
892010.1­
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Fontaine,
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Supplemental
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Fontaine,
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Hoxter,
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Technical
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168B:
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Sheets,
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A
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122­
LE;
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215
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42342301
Stafford,
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Technical
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106
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42342303
Burger,
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Triadimefon
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Magnitude
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Lab
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Miles,
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386
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42342304
Burger,
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Triadimefon
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Magnitude
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Lab
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BL
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Miles,
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319
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42342305
Burger,
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1992)
Triadimefon
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Magnitude
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Lab
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BL
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Unpublished
study
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Miles,
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409
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42342306
Burger,
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Triadimefon
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Magnitude
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Lab
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BL
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Miles,
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303
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42342307
Burger,
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Triadimefon
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Magnitude
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Lab
Project
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BL
19PN02:
39256:
102649.
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Miles,
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ABC
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Dole
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416
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42342308
Burger,
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Triadimefon
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Magnitude
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Lab
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BL
19SQ01:
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102629.
Unpublished
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prepared
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Miles,
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420
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Burger,
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1992)
Triadimefon
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Magnitude
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Processed
Apple
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Lab
Project
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BL­
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39591:
102636.
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study
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Miles
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233
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Cain,
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Leaching
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Lab
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BL092101:
102631.
Unpublished
study
prepared
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Miles
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33
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Clemens,
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1992)
A
Developmental
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Lab
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Schmidt,
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Head,
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1992)
Anaerobic
Aquatic
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?
carbon­
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Triadimefon:
Lab
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103207:
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42409101
Chopade,
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Disposition
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Phenyl­
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carbon
14|
Triadimefon
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BLO41801:
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251
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Mattern,
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Confined
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Phenyl­
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carbon
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Triadimefon
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Lab
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BL051601:
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P309W:
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Williams,
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Triadimenol­­
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42696309
Williams,
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Triadimenol­­
Magnitude
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Lab
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BT19OA01:
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Williams,
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Triadimenol­­
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Krolski,
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Fate
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carbon
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25
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Mass
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carbon
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42853401
Chopade,
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Metabolism
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Phenyl­
UL­(
carbon
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Triadimefon
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Lab
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Hall,
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The
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carbon
14)
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Lab
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BL041001:
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160
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42857401
Williams,
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Triadimefon
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Metabolites­­
Freezer
Storage
Stability
Study
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Raw
Agricultural
Commodities
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Processed
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Lab
Project
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396832:
BL131601:
102641­
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Unpublished
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ABC
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150
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Duah,
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Metabolism
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Lab
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Unpublished
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129
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Eberhart,
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Evaluation
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Lab
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432
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Bowers,
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Acute
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Technical
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Rainbow
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mykiss)
Under
Static
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BL812201:
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Burger,
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Triadimefon
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Magnitude
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Lab
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BL19GR03:
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Unpublished
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Toxicity
of
BAYLETON
Technical
to
the
Bluegill
(
Lepomis
macrochirus)
under
Static­
Renewal
Conditions:
Lab
Project
Number:
BL810301:
106758.
Unpublished
study
prepared
by
Miles
Environmental
Research
Section.
27
p.

43418301
Hall,
L.;
Hartz,
A.
(
1994)
The
Metabolism
of
(
carbon
14)
Triadimefon
in
the
Lactating
Goat:
Addendum
1:
Additional
Data
as
Requested
by
the
EPA:
Lab
Project
Number:
BL041001:
105161­
1.
Unpublished
study
prepared
by
Miles,
Inc.
12
p.

43418302
Duah,
F.;
Myers,
T.
(
1994)
Metabolism
of
Triadimefon
in
Laying
Hens:
Addendum
1:
Additional
Data
as
Requested
by
EPA:
Lab
Project
Number:
BL040501:
105183­
1.
Unpublished
study
prepared
by
Miles,
Inc.
17
p.

43418303
Duah,
F.;
Myers,
T.;
Freeseman,
P.
(
1994)
Extraction
Efficiency
of
the
Analytical
Method
for
Triadimefon
Residues
in
Meat,
Milk,
and
Eggs:
Lab
Project
Numbers:
BL200201:
106449.
Unpublished
study
prepared
by
Miles,
Inc.
44
p.

43462401
Duah,
F.
(
1994)
Storage
Stability
of
Triadimefon
Residues
in
Animal
Tissues,
Milk,
and
Eggs:
Lab
Project
Number:
BL130201:
106638.
Unpublished
study
prepared
by
Miles
Inc.
37
p.

43495509
Beyrouty,
P.
(
1992)
An
Acute
Study
of
the
Potential
Effects
of
Orally
Administered
Triadimefon
on
Behavior
in
Rats:
Lab
Project
Number:
97132.
Unpublished
study
prepared
by
Bio­
Research
Lab.
Ltd.
276
p.

43705401
Fomenko,
J.
(
1995)
Evaluation
of
KWG
1732
(
a
Tridimefon
Metabolite)
Through
the
FDA
Multiresidue
Methods:
Lab
Project
Numbers:
K2162301:
106963:
A012.009.
Unpublished
study
prepared
by
Huntingdon
Analytical
Services.
97
p.

43870101
Bajzik,
M.
(
1995)
Independent
Laboratory
Validation
of
the
Analytical
Residue
Method
for
Triadimefon
and
Metabolites
in
Plant
Matrices
(
Report
No.
106549):
Lab
Project
Number:
A012.014:
BL111601:
107141.
Unpublished
study
prepared
by
Huntingdon
Analytical
Services.
121
p.

43936101
Dreist,
M.;
Popp,
A.
(
1996)
MEB
6447
(
Common
Name:
Triadimefon):
Acute
Oral
Neurotoxicity
Screening
Study
in
Wistar
Rats:
Lab
Project
Number:
24636:
1058215:
107154.
Unpublished
study
prepared
by
Bayer
AG.
468
p.

43948601
Murphy,
J.
(
1996)
Triadimefon
(
50DF)­­
Magnitude
of
the
Residue
on
Processed
Apple
Commodities:
Addendum
1:
Additional
Information
Requested
by
EPA:
Lab
Project
Number:
BL19AP02:
102636­
1:
39591.
Unpublished
study
prepared
by
Bayer
Corp.
8
p.
107
MRID
Citation
Reference
44038901
Lenz,
C.
(
1996)
Triadimefon
and
Metabolites­­
Freezer
Storage
Stability
Study
in
Raw
Agricultural
Commodities
and
Processed
Commodities:
Addendum
2:
Lab
Project
Number:
BL131601:
102641­
2:
39683.
Unpublished
study
prepared
by
ABC
Laboratories,
Inc.
586
p.

44041001
Chopade,
H.
(
1996)
Metabolism
of
(
Phenyl­
UL­(
carbon
14))
Triadimefon
in
Wheat:
Addendum
1­­
Storage
Stability
of
(
carbon
14)
KWG
1732
in
Wheat
Grain:
Lab
Project
Number:
BL221601:
105162­
1.
Unpublished
study
prepared
by
Bayer
Corp.
30
p.

44041002
Chopade,
H.
(
1996)
Extraction
Efficiency
of
the
Analytical
Residue
Method
for
the
Determination
of
Triadimefon
and
Metabolite
Residues
in
Plant
Matrices:
Determination
of
Aged
(
carbon
14)
Triadimefon
Residues
in
Wheat
Grain:
Lab
Project
Number:
BL221601:
107343.
Unpublished
study
prepared
by
Bayer
Corp.
35
p.

44153501
Dreist,
M.;
Popp,
A.
(
1996)
MEB
6447
(
Common
Name:
Triadimefon):
Subchronic
Neurotoxicity
Screening
Study
in
Wistar
Rats:
(
Thirteen­
Week
Administration
in
the
Diet
with
a
Four­
Week
Recovery
Period
in
Males
and
a
Ten­
Week
Recovery
Period
in
Females):
Lab
Project
Number:
25315:
T
6058265:
107477.
Unpublished
study
prepared
by
Bayer
AG.
786
p.

44166001
Fontaine,
L.
(
1996)
Product
Chemistry
of
Bayleton
Technical:
Lab
Project
Number:
107296:
107241:
99642.
Unpublished
study
prepared
by
Bayer
Corp.
173
p.

44519801
Shen,
S.
(
1998)
Determination
of
Residues
of
Baytan
30
in
Processed
Field
Corn
Fractions:
Lab
Project
Number:
96­
003:
963HI:
43514.
Unpublished
study
prepared
by
ABC
Labs.,
Inc.
and
Gustafson
Research
and
Development
Center.
458
p.
{
OPPTS
860.1520}

44519802
Shen,
S.
(
1998)
Determination
of
Residues
of
Baytan
30
in
Processed
Cotton
Fractions:
Lab
Project
Number:
96­
001:
963HG:
43516.
Unpublished
study
prepared
by
ABC
Labs.,
Inc.
and
Gustafson
Research
and
Development
Center.
452
p.
{
OPPTS
860.1520}

44519803
Shen,
S.
(
1998)
Determination
of
Residues
of
Baytan
30
in
Processed
Wheat
Fractions:
Lab
Project
Number:
96­
002:
963HH:
43513.
Unpublished
study
prepared
by
ABC
Labs.,
Inc.
and
Gustafson
Research
and
Development
Center.
462
p.
{
OPPTS
860.1520}

44740901
Schaldt,
L.
(
1998)
KWG
0519
Oncogenicity
Study
in
CD­
1
Mice
(
Dietary
Administration
over
18
Months):
Lab
Project
Number:
28299:
T4060738:
108689.
Unpublished
study
prepared
by
Bayer
AG.
1854
p.

45654503
Findlay,
M.;
Chester,
G.
(
1995)
Seed
Treated
Products:
Worker
Exposure
During
Sowing
of
Treated
Seed
with
"
Baytan":
Lab
Project
Number:
N(
DEGREES)
WER002.
Unpublished
study
prepared
by
ZENECA
Agrochemicals.
107
p.

46576207
Mithcell,
H.
(
2005)
Product
Chemistry
of
Bayleton
FLO
Fungicide.
Project
Number:
BR/
2392,
ANR/
06605,
3414519/
1.
Unpublished
study
prepared
by
Bayer
Corp.
134
p.

46578707
Mitchell,
H.
(
2005)
Product
Chemistry
of
Tartan
Flo
Fungicide.
Project
Number:
BR/
2390,
ANR/
04605,
ANR/
04705.
Unpublished
study
prepared
by
Bayer
Corp.
205
p.

46836301
Mitchell,
H.
(
2006)
Product
Chemistry
of
Bayleton
3.62%
SC
Systemic
Fungicide.
Project
Number:
BR/
2462,
201435,
ANR/
03006.
Unpublished
study
prepared
by
Bayer
Corp.
180
p.
108
MRID
Citation
Reference
92188018
Eigenberg,
D.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00149336.
A
Teratological
Evaluation
of
Bayleton
(
Triadimefon)
in
Mated
Female
Rats:
Project
7272­
B
(
Mobay
Report
82270).
Prepared
by
MIDWEST
RESEARCH
INSTITUTE.
22
p.

92188019
Eigenberg,
D.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00155075
and
Related
MRIDs
00032541.
MEB
6447
(
Triadimefon)
Multigeneration
Reproduction
Study
on
Rats;
(
Triadimefon)
Two­
generation
Study
with
Rats
(
Bayleton):
Projects
8297
and
12712
(
Mobay
Reports
67752
and
82270).
Prepared
by
BAYER
AG.
38
p.

92188020
Loser,
E.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00032541
and
Related
MRIDs
00155075.
MEB
6447
(
Triadimefon)
Multigeneration
Reproduction
Study
on
Rats:
Project
Number
67752;
Report
No.
8297.
Prepared
by
BAYER
AG.
173
p.

92188025
Chopade,
H.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00025540.
The
Metabolism
of
BAYLETON
in
Apples:
Project
Report
No.
53621.
Prepared
by
MOBAY
CORPORATION.
14
p.

92188026
Mango,
R.;
Puhl,
R.;
Thornton,
J.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00025540.
The
Metabolism
of
BAYLETON
in
Apples:
Project
No.
53621.
Prepared
by
MOBAY
CORPORATION.
26
p.

92188027
Chopade,
H.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00031440
and
Related
MRIDs
00031441.
Fate
of
BAYLETON­
Carbon­
14
as
a
25%
Wettable
Powder
on
Tomatoes
and
Cucumbers:
Project
Report
Nos.
68593
and
68594.
Prepared
by
MOBAY
CORPORATION.
13
p.

92188028
Nye,
D.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00031440.
Fate
of
BAYLETON­
Carbon­
14
as
a
25
Percent
Wettable
Powder
on
Tomatoes
and
Cucumbers:
Project
Report
68593.
Prepared
by
STONER
LABORATORIES,
INC.
33
p.

92188029
Puhl,
R.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00031441.
Further
Identification
of
Polar
Activity
from
BAYLETON
Cucumber
and
Tomato
Metabolism
Samples:
Project
Report
No.
68594.
Prepared
by
MOBAY
CORPORATION.
10
p.

92188030
Chopade,
H.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00098115.
Metabolism
of
BAYLETON
in
Wheat:
Project
Report
No.
80293.
Prepared
by
MOBAY
CORPORATION.
14
p.

92188031
Morgan,
J.;
Lenz,
M.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00098115.
Metabolism
of
BAYLETON
in
Wheat:
Project
Report
No.
80293.
Prepared
by
MOBAY
CORPORATION.
29
p.

92188032
Chopade,
H.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00150893.
Metabolism
of
BAYLETON
on
Grapes:
Project
Report
No.
88790.
Prepared
by
MOBAY
CORPORATION.
12
p.

92188033
Fredrickson,
R.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00150893.
Metabolism
of
BAYLETON
on
Grapes:
Project
Report
No.
88790.
Prepared
by
MOBAY
CORPORATION.
21
p.

92188034
Chopade,
H.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00025543.
Metabolism
of
BAYLETON
in
the
Cow:
Project
Report
No.
66202.
Prepared
by
MOBAY
CORPORATION.
11
p.
109
MRID
Citation
Reference
92188035
Fredrickson,
D.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00025543.
Metabolism
of
BAYLETON
in
the
Cow:
Project
Report
No.
66202.
Prepared
by
MOBAY
CORPORATION.
19
p.

92188036
Premkumar,
N.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00033058.
Metabolism
of
BAYLETON
in
Male
and
Female
Pigs:
Project
No.
66509.
Prepared
by
MOBAY
CORPORATION.
16
p.

92188037
Pither,
K.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00033058.
Metabolism
of
BAYLETON
in
Male
and
Female
Pigs:
Project
Report
No.
66509.
Prepared
by
MOBAY
CORPORATION.
25
p.

92188038
Mathew,
A.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00033070.
The
Fate
of
BAYLETON­
Carbon­
14
in
Poultry:
Project
Report
No.
67482.
Prepared
by
MOBAY
CORPORATION.
16
p.

92188039
Nye,
D.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00033070.
The
Fate
of
BAYLETON­
Carbon­
14
in
Poultry:
Project
Report
No.
67482.
Prepared
by
STONER
LABORATORIES,
INC.
67
p.

92188040
Obrist,
J.;
Nichols,
S.;
Leimkuehler,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00025546.
An
Interference
Study
for
the
BAYLETON
and
KWG
0519
Residue
Method
for
Crops:
Project
Report
No.
68006.
Prepared
by
MOBAY
CORPORATION.
208
p.

92188041
Leimkuehler,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00125782.
An
Interference
Study
for
BAYLETON
Residue
Method
for
Crops
­
Resolution
of
Interference
for
KWG
1342
and
KWG
1323:
Project
Report
No.
80567.
Prepared
by
MOBAY
CORPORATION.
225
p.

92188042
Chopade,
H.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00149163
and
Related
MRIDs
00025546,
00125782.
Residue
Analysis
Procedure
for
BAYLETON
and
Metabolites
in
Plants:
Project
Report
Nos.
80488,
68006
and
80567.
Prepared
by
MOBAY
CORPORATION.
16
p.

92188043
Obrist,
J.;
Leimkuehler,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00149163.
Residue
Analysis
Procedure
for
BAYLETON
and
Metabolites
in
Barley
and
Wheat:
Project
Report
No.
80488.
Prepared
by
MOBAY
CORPORATION.
28
p.

92188044
Minor,
R.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00090019
and
Related
MRIDs
00090020,
00063837,
00072538,
00149342,
00063835.
Analytical
Methods
for
BAYLETON
in
Various
Animal
Tissues:
Project
Report
Nos.
69531,
80265,
68705,
68798,
69028
and
68887.
Prepared
by
ANALYTICAL
DEVELOPMENT
CORP.
21
p.

92188045
Kruplak,
J.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00090019.
BAYLETON
Total
Residue
Method
Verification
(
Bovine):
Project
Report
No.
69531.
Prepared
by
ANALYTICAL
DEVELOPMENT
CORP.
158
p.

92188046
Obrist,
J.;
Nichols,
S.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00063835.
An
Interference
Study
for
the
BAYLETON
and
KWG
0519
Residue
Method
for
Bovine
Tissues
and
Milk:
Project
report
No.
68887.
Prepared
by
MOBAY
CORPORATION.
67
p.
110
MRID
Citation
Reference
92188047
Kruplak,
J.;
Weissenburger,
B.;
Bache
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00063837.
Determination
of
BAYLETON
and
KWG
0519
in
Cattle
Tissues:
Project
Report
No.
68705.
Prepared
by
ANALYTICAL
DEVELOPMENT
CORP.
31
p.

92188048
Kruplak,
J.;
Bache,
B.;
Breault,
G.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00072538.
Residue
Analysis
Procedure
for
the
Determination
of
BAYLETON
and
KWG
0519
in
Bovine
Milk:
Project
Report
No.
68798.
Prepared
by
ANALYTICAL
DEVELOPMENT
CORP.
19
p.

92188051
Premkumar,
N.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00025541
and
Related
MRIDs
00098117,
41027902.
Storage
Stability
of
BAYLETON,
BAYTAN,
KWG
1323
and
KWG
1342
in
Apple
Peel,
Potatoes,
Grapes
and
Wheat
Green
Forage;
and
Storage
Stability
of
KWG
1323
and
KWG
1342
in
Wheat
Grain:
Project
Report
Nos.
54192,
80338
and
98432.
Prepared
by
MOBAY
CORPORATION.
11
p.

92188052
Thornton,
J.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00025541.
The
Stability
of
BAYLETON
and
KWG
0519
Residues
in
Apple
Peel
During
Frozen
Storage:
Project
Report
No.
54192.
Prepared
by
MOBAY
CORPORATION.
8
p.

92188053
Fredrickson,
D.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00098117.
The
Stability
of
BAYLETON
and
BAYTAN
Residues
in
Wheat
Forage
During
Storage:
Project
Report
No.
80338.
Prepared
by
MOBAY
CORPORATION.
7
p.

92188054
Bornatsch,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00090021.
Effect
of
Feeding
BAYLETON
and
the
Metabolite
KWG
0519
(
BAYTAN)
to
Dairy
Cattle
­­
Total
Residue:
Project
Report
No.
69930.
Prepared
by
MOBAY
CORPORATION.
9
p.

92188055
Kruplak,
J.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00090021.
Effect
of
Feeding
BAYLETON
and
the
Metabolite
KWG
0519
(
BAYTAN)
to
Dairy
Cattle
­­
Total
Residues:
Project
Report
No.
69930.
Prepared
by
ANALYTICAL
DEVELOPMENT
CORP.
247
p.

92188056
Mathew,
A.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00090022.
Effect
of
Feeding
BAYLETON
and
the
Metabolite
KWG
0519
(
BAYTAN)
to
Poultry
­
Total
Residue:
Project
No.
80281.
Prepared
by
MOBAY
CORPORATION.
12
p.

92188057
Kruplak,
J.;
Weissenburger,
B.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00090022.
Effect
of
Feeding
BAYLETON
and
the
Metabolite
KWG
0519
(
BAYTAN)
to
Poultry
­
Total
Residues:
Project
Report
No.
80281.
Prepared
by
ANALYTICAL
DEVELOPMENT
CORP.
174
p.

92188060
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00067381
and
Related
MRIDs
00109463.
Triadimefon
(
BAYLETON
25WP
Formulation)
­
Magnitude
of
the
Residues
on
Chick
Peas:
Project
Report
Nos.
68905,
68906,
68907,
68908,
68909,
80723,
80930
and
80931;
Mobay
Report
No.
100117­
1.
Prepared
by
MOBAY
CORPORATION.
13
p.

92188061
Biehn,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00143953
and
Related
MRIDs
00153279.
Triadimefon:
Magnitude
of
the
Residue
on
Raspberries:
IR­
4
No.
2552.
Prepared
by
ICI
Americas
Inc.
20
p.
111
MRID
Citation
Reference
92188062
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00072532
and
Related
MRIDs
00149342.
Triadimefon
(
BAYLETON
50WP
Formulation)
­
Magnitude
of
the
Residues
on
Seed
Grass:
Project
Report
Nos.
80670,
80673,
80674,
80675
and
80676;
Mobay
Report
No.
100114­
1.
Prepared
by
MOBAY
CORPORATION.
12
p.

92188063
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00128337.
Triadimefon
(
BAYLETON
50WP
Formulation)
Magnitude
of
the
Residues
on
Sugar
Beets:
Project
Report
Nos.
81198,
81199,
82800,
82801,
82802,
82803,
82804,
82805,
82806,
82807,
82808,
82809,
82811,
82814,
82815,
82816,
82817
and
82818;
Mobay
Report
100115­
1.
Prepared
by
MOBAY
CORPORATION.
17
p.

92188064
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00098114
and
Related
MRIDs
00149329,
00061736.
Magnitude
of
the
Residues
on
Wheat:
Objective
No.
(
3012):
Report
Nos.
80494,
80495,
80530,
80542,
80545,
80546,
80547,
80550,
80551,
80552,
80553,
82821,
82874,
84208,
82822
and
82824;
Mobay
Report
No.
100111­
1.
Prepared
by
MOBAY
CORPORATION.
14
p.

92188065
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Summary
of
MRID
00128337.
Triadimefon
(
BAYLETON
50WP
Formulation)
­
Magnitude
of
the
Residue
in
Unprocessed
Sugar
Beets
and
Sugar
Beet
Processed
Products:
Project
Report
Nos.
84211,
84212
and
82811;
Mobay
Report
No.
100116­
1.
Prepared
by
MOBAY
CORPORATION.
12
p.

92188069
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00128337.
Triadimefon
(
BAYLETON
50WP
Formulation)
­
Magnitude
of
the
residues
in
Unprocessed
Sugar
Beets
and
Sugar
Beet
processed
Products:
Project
Nos.
(
82811,
84211,
84212);
Mobay
Report
No.
100116.
Prepared
by
MOBAY
CORPORATION.
56
p.

92188070
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00067381
and
Related
MRIDs
00109463.
Triadimefon
(
BAYLETON
25WP
Formulation)
­
Magnitude
of
the
Residues
on
Chick
Peas
(
Project
Nos.
68905,
68906,
68907,
68908,
68909,
80723,
80930,
80931);
Mobay
Report
No.
100117.
Prepared
by
MOBAY
CORPORATION.
55
p.

92188073
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00128337.
Triadimefon
(
BALETON
50WP)
­
Magnitude
of
the
Residues
on
Sugar
Beets:
(
Project
Nos.
81198,
81199,
82205,
82206,
82207,
82800,
82801,
82802,
82812,
82813,
82814,
82815,
82816,
82817,
82818);
Mobay
Report
No.
10115.
Prepared
by
MOBAY
CORPORATION.
204
p.

92188074
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00098114
and
Related
MRIDs
00149329,
00061736.
Triadimefon
(
BAYLETON
50WP
Formulation)
­
Magnitude
of
the
Residues
on
Wheat:
(
Report
Nos.
80494,
80495,
80530,
80542,
80545,
80546,
80547,
80550,
80551,
80552,
80553,
82821,
82874,
84208,
82822,
82824);
Mobay
Report
No.
100111.
Prepared
by
MOBAY
CORPORATION.
219
p.

92188075
Leslie,
W.
(
1990)
Mobay
Corporation
Phase
3
Reformat
of
MRID
00072532
and
Related
MRIDs
00149342.
Triadimefon
(
BAYLETON
50WP
Formulation)
­
Magnitude
of
the
Residues
on
Seed
Grass:
Project
Report
Nos.
(
80670,
80673,
80674,
80675,
80676,
82848,
82854,
82855,
82856,
82857,
82858);
Mobay
Report
100114.
Prepared
by
MOBAY
CORPORATION.
121
p.

92188320
Bayer
Ag
Institute
of
Toxicology;
Two
Generation
Study
with
Rats;
Report
No.:
12712,
Report
Author:
Dr.
R.
Eiben
(
Also
under
MRIDs
00155075,
92188019
and
TRID
Number
470102­
011).
112
MRID
Citation
Reference
Allen,
J.,
Wolf,
D.,
George,
M.
Hester,
S.,
Sun
G.,
Thai,
S­
F.,
Delker,
D.,
Nelson,
G.,
Winkfield,
E.
Roop,
B.,
Leavitt,
S.,
Ward,
W.,
and
Nesnow,
S.
(
2005)
Comparable
Liver
P450
Enzyme
Activity
and
Histopathology
in
Mice
Treated
With
the
Conazole
Fungicides:
Myclobutanil,
Propiconazole
and
Triadimefon.
The
Toxicologist.
Abstract.
No,
2146.

Crofton,
KM.
1996.
A
structure­
activity
relationship
for
the
neurotoxicity
of
triazole
fungicites.
Toxicol.
Lett
84
(
3):
155­
159.

Crofton,
KM.,
Boneck,
VM.,
and
Reiter,
LW.
1988.
Hyperactivity
induced
by
triaedimefon,
a
triazole
fungicide.
Fundam.
Appl.
Toxicol.
10,
459­
465.

Crofton,
KM.,
Boneck,
VM.,
and
MacPhail,
RC.
1989.
Evidence
for
monoaminergic
involvement
in
triadimefon­
induced
hyperactivity,
Psychopharmacology
97,
326­
330.

Crofton,
KM.,
Howard,
JL.,
Moser,
VC.,
Gill,
MW.,
et
al.
1991.
Interlaboratory
comparison
of
motor
activity
experiments:
implications
for
neurotoxicological
assessments.
Neurotoxicol.
Teratol.
13
(
6):
599­
609.

Crofton,
KM.,
Makris,
SL.,
Sette,
WF.,
Mendez,
E.,
and
Raffaele,
KC.
2004.
A
qualitative
retrospective
analysis
of
positive
control
data
in
developmental
neurotoxicity
studies.
Neurotoxicology
and
Teratology
26;
345­
352.352.

Goetz,
A.
K.,
Blystone,
C.,
Ren,
H.,
Schmid,
J.
E.,
Nichols,
H.
P.,
Bao,
W.,
Best,
D.
S.,
Narotsky,
M.
G.,
Wolf,
D.
C.,
Rockett,
J.
C.,
and
Dix,
D.
J.
(
2005)
Reproductive
Effects
of
Exposure
to
Conazole
Fungicides
in
the
Male
Rat.
The
Toxicologist.
Abstract
No
2148.

Golub,
M.,
Costa,
L.,
Crofton,
K.,
Frank,
D.,
Fried,
P.,
Gladen,
B.,
Henderson,
R.,
Liebelt,
E.,
Lusskin,
S.,
Marty,
S.,
Rowland,
A.,
Scialli,
J.,
and
Vore,
M.
2005.
NTP­
CERHR
expert
panel
report
on
the
reproductive
and
developmental
toxicity
of
methylphenidate.
Birth
Defects
Research
(
part
B)
74:
300­
381.

Hester,
S.,
Thai,
S.­
F.,
Wolf,
D.,
Ward,
W.,
and
Nesnow,
S.
(
2005)
Comparison
of
Gene
Expression
Profiles
from
Rats
Fed
Acute
Levels
of
Three
Toxicologically
Different
Conazoles.
The
Toxicologist.
Abstract
No.
2149.

Ikaiddi,
MU.,
Akunne,
HC.,
and
Soliman,
KE.
1997.
Behavioral
and
neurochemical
effects
of
acute
and
repeated
administration
of
triadimefon
in
the
male
rat.
Neurotoxicology
18(
3):
771­
80.

Moser,
VC
and
MacPhail,
RC.
1989.
Neurobehavioral
effects
of
triadimefon,
a
triazole
fungicide,
in
male
and
female
rats.
Neurotoxicol.
Teratol.
11,
285­
293.

Moser,
VC
and
MacPhail,
RC.
1992.
International
validation
of
the
neurobehavioral
screening
battery:
The
IPCS/
WHO
collaborative
study.
Toxicol.
Lett.
64­
65
Spec.
No.,
217­
223.

Moser,
VC.,
Cheek,
BM.,
and
MacPhail,
RC.
1995.
A
multidisciplinary
approach
to
toxicological
screenings:
III.
Neurobehavioral
toxicity.
Journal
Toxicol
Environ
Health
Jun
45(
2):
173­
210.
None
None
None
None
None
None
None
None
None
None
None
None
None
None
Ren,
H.,
Schmid,
J.
E.,
Retief,
J.,
Turpaz,
Y.,
Zhang,
X.,
Jones,
P.
D.,
Newsted,
J.
L.,
Giesy,
J.
P.,
Wolf,
D.
C.,
Wood,
C.
R.,
Bao,
W.,
and
Dix,
D.
J.
(
2005)
Profiling
Gene
Expression
in
Human
H295R
Adrenocortical
Carcinoma
Cells
and
Rat
Testes
to
Identify
Pathways
of
113
MRID
Citation
Reference
Toxicity
for
Conazole
Fungicides.
The
Toxicologist.
Abstract
No.
2150.

Sun
G,
Thai
SF,
Tully
DB,
Lambert
GR,
Goetz
AK,
Wolf
DC,
Dix
DJ,
Nesnow
S:
Propiconazole­
induced
cytochrome
P450
gene
expression
and
enzymatic
activities
in
rat
and
mouse
liver.
Tox
Lett
155:
277­
287,
2004;
and
abstracts
from
the
2005
SOT
meeting,

Walker,
QD
and
Mailman,
RB.
1996.
Triadimefon
and
triadimenol:
effects
on
monoamine
uptake
and
release.
Toxicol.
Appl.
Pharmacol.
139
(
2):
227­
233.

Ward,
W.,
Delker,
D.,
Hester,
S.,
Thai,
S­
F.,
Allen,
J.,
Jones,
C.,
Wolf,
D.,
and
Nesnow,
S.
(
2005)
Comparison
of
Hepatic
Gene
Expression
Profiles
from
Mice
Exposed
to
Three
Toxicologically
Different
Conazoles.
The
Toxicologist.
Abstract
No.
2147.
None
None
None
None
Wolf,
D.
C.,
Allen,
J.,
Sun,
G.,
Thibodeaux,
J.,
George,
M.,
Hester,
S.
D.,
Thai,
S.­
F.,
Delker,
D.,
Nelson,
G.,
Winkfield,
E.,
Roop,
B.,
Leavitt,
S.,
Ward,
W.,
and
Nesnow,
S.
(
2005)
Triadimefon
Induces
Rat
Thyroid
Tumors
Through
a
Non­
TSH
Mediated
Mode
of
Action.
The
Toxicologist.
Abstract
No.
2144.
114
Appendix
E.
Generic
Data
Call­
In
115
Appendix
E.
The
generic
data
call­
in
will
be
posted
at
a
later
date.
116
Appendix
F.
Product
Specific
Data
Call­
In
117
Appendix
F.
The
product
specific
data
call­
in
will
be
posted
at
a
later
date.
118
Appendix
G:
Batching
of
Triadimenol/
Triadimefon
Products
EPA'S
BATCHING
OF
TRIADIMENOL/
TRIADIMEFON
PRODUCTS
FOR
MEETING
ACUTE
TOXICITY
DATA
REQUIREMENTS
FOR
REREGISTRATION
In
an
effort
to
reduce
the
time,
resources
and
number
of
animals
needed
to
fulfill
the
acute
toxicity
data
requirements
for
reregistration
of
products
containing
TRIADIMENOL
or
TRIADIMEFON
as
the
active
ingredient,
the
Agency
has
batched
products
which
can
be
considered
similar
for
purposes
of
acute
toxicity.
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(
identity,
percent
composition
and
biological
activity),
type
of
formulation
(
e.
g.,
emulsifiable
concentrate,
aerosol,
wettable
powder,
granular,
etc.),
and
labeling
(
e.
g.,
signal
word,
use
classification,
precautionary
labeling,
etc.).
Note
that
the
Agency
is
not
describing
batched
products
as
"
substantially
similar"
since
some
products
within
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.

Using
available
information,
batching
has
been
accomplished
by
the
process
described
in
the
preceding
paragraph.
Notwithstanding
the
batching
process,
the
Agency
reserves
the
right
to
require,
at
any
time,
acute
toxicity
data
for
an
individual
product
should
the
need
arise.

Registrants
of
products
within
a
batch
may
choose
to
cooperatively
generate,
submit
or
cite
a
single
battery
of
six
acute
toxicological
studies
to
represent
all
the
products
within
that
batch.
It
is
the
registrants'
option
to
participate
in
the
process
with
all
other
registrants,
only
some
of
the
other
registrants,
or
only
their
own
products
within
a
batch,
or
to
generate
all
the
required
acute
toxicological
studies
for
each
of
their
own
products.
If
a
registrant
chooses
to
generate
the
data
for
a
batch,
he/
she
must
use
one
of
the
products
within
the
batch
as
the
test
material.
If
a
registrant
chooses
to
rely
upon
previously
submitted
acute
toxicity
data,
he/
she
may
do
so
provided
that
the
data
base
is
complete
and
valid
by
today's
standards
(
see
acceptance
criteria
attached),
the
formulation
tested
is
considered
by
EPA
to
be
similar
for
acute
toxicity,
and
the
formulation
has
not
been
significantly
altered
since
submission
and
acceptance
of
the
acute
toxicity
data.
Regardless
of
whether
new
data
is
generated
or
existing
data
is
referenced,
registrants
must
clearly
identify
the
test
material
by
EPA
Registration
Number.
If
more
than
one
confidential
statement
of
formula
(
CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
actually
tested
by
identifying
the
corresponding
CSF.

In
deciding
how
to
meet
the
product
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call­
In
Notice
and
its
attachments
appended
to
the
RED.
The
DCI
Notice
contains
two
response
forms
which
are
to
be
completed
and
submitted
to
the
Agency
within
90
days
of
receipt.
The
first
form,
"
Data
Call­
In
Response,"
asks
whether
the
registrant
will
meet
the
data
requirements
for
each
product.
The
second
form,
"
Requirements
Status
and
Registrant's
Response,"
lists
the
product
specific
data
required
for
each
product,
including
the
standard
six
acute
toxicity
tests.
A
registrant
who
wishes
to
participate
in
a
batch
must
decide
whether
he/
she
will
provide
the
data
or
depend
on
someone
else
to
do
so.
If
a
registrant
supplies
the
data
to
support
a
batch
of
products,
he/
she
must
119
select
one
of
the
following
options:
Developing
Data
(
Option
1),
Submitting
an
Existing
Study
(
Option
4),
Upgrading
an
Existing
Study
(
Option
5)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
depends
on
another's
data,
he/
she
must
choose
among:
Cost
Sharing
(
Option
2),
Offers
to
Cost
Share
(
Option
3)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
does
not
want
to
participate
in
a
batch,
the
choices
are
Options
1,
4,
5
or
6.
However,
a
registrant
should
know
that
choosing
not
to
participate
in
a
batch
does
not
preclude
other
registrants
in
the
batch
from
citing
his/
her
studies
and
offering
to
cost
share
(
Option
3)
those
studies.

Seven
products
were
found
which
contain
Triadimenol
as
the
active
ingredient.
These
products
have
been
placed
in
a
no
batch
group
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation
Batching
Instructions
for
Triadimenol:

No
Batch:
Each
product
in
this
Batch
should
generate
their
own
data.

NOTE:
The
technical
acute
toxicity
values
included
in
this
document
are
for
informational
purposes
only.
The
data
supporting
these
values
may
or
may
not
meet
the
current
acceptance
criteria.

No
Batch
EPA
Reg.
No.
Percent
Active
Ingredient
264­
742
25.00
264­
743
98.30
264­
760
28.30
264­
939
Triademinol:
5.00
Tetramethylthiuram
disulfide:
15.30
264­
941
30.00
264­
980
Triademinol:
13.33
Azoxystrobin:
8.00
Metalaxyl:
40.00
2935­
459
30.00
Fifty
one
products
were
found
which
contain
Triadimefon
as
the
active
ingredient.
These
products
have
been
placed
in
seven
batches
and
a
no
batch
group
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.

Batching
Instructions
for
Triadimefon:

Batch
3A:
Products
in
this
Batch
may
cite
studies
conducted
on
products
in
Batch
3.

Batch
6:
Each
product
in
this
Batch
must
conduct
a
primary
eye
irritation
study
using
the
fertilizer
with
the
highest
percentage
of
nitrogen.
120
No
Batch:
Each
product
in
this
Batch
should
generate
their
own
data.

NOTE:
The
technical
acute
toxicity
values
included
in
this
document
are
for
informational
purposes
only.
The
data
supporting
these
values
may
or
may
not
meet
the
current
acceptance
criteria.

Batch
1
EPA
Reg.
No.
Percent
Active
Ingredient
264­
737
50.0
264­
740
50.0
432­
1294
50.0
432­
1360
50.0
432­
1367
50.0
Batch
2
EPA
Reg.
No.
Percent
Active
Ingredient
432­
1293
25.0
432­
1309
25.0
432­
1316
25.0
432­
1317
25.0
Batch
3
EPA
Reg.
No.
Percent
Active
Ingredient
4­
342
1.0
432­
1295
1.0
432­
1336
1.0
961­
354
1.0
8378­
55
1.0
9198­
111
1.0
10404­
58
1.0
28293­
278
1.0
32802­
41
1.0
34704­
802
1.0
Batch
3A
EPA
Reg.
No.
Percent
Active
Ingredient
4­
362
0.50
432­
1296
0.50
869­
224
0.50
829­
288
0.50
961­
353
0.50
7401­
432
0.50
8378­
54
0.50
8660­
199
0.78
121
9198­
112
0.50
9198­
187
0.59
28293­
280
0.50
32802­
42
0.50
72155­
47
0.50
Batch
4
EPA
Reg.
No.
Percent
Active
Ingredient
432­
1297
0.88
829­
289
0.88
72155­
48
0.88
Batch
5
EPA
Reg.
No.
Percent
Active
Ingredient
869­
222
0.88
2724­
691
0.88
Batch
6
EPA
Reg.
No.
Percent
Active
Ingredient
961­
388
0.10
961­
389
0.05
9198­
190
0.62
10404­
65
0.50
No
Batch
EPA
Reg.
No.
Percent
Active
Ingredient
264­
736
97.70
264­
757
Triadimefon:
2.10
Sulfur:
53.70
432­
1300
22.00
432­
1412
Triadimefon:
8.33
Trifloxystrobin:
41.67
432­
1445
43.00
432­
1446
Triadimefon:
20.86
Trifloxystrobin:
4.17
9198­
169
Triadimefon:
16.00
Metalaxyl:
16.00
9198­
197
Triadimefon:
1.59
Thiram:
40.76
64014­
3
0.88
72155­
46
1.00
122
H.
List
of
Registrants
Sent
this
Data
Call­
In
United
States
Environmental
Protection
Agency
Washington,
D.
C.
20460
LIST
OF
ALL
REGISTRANTS
SENT
THIS
DATA
CALL­
IN
NOTICE
Case
#
and
Name:
2700,
Triadimefon
Co.
Number
Company
Name
Agent
for
Address
City
and
State
Zip
264
BAYER
CROPSCIECNCE
2
T.
W.
Alexander
Drive
Research
Triangle
Park
NC
27709
123
Appendix
I.
List
of
Available
Related
Documents
and
Electronically
Available
Forms
Pesticide
Registration
Forms
are
available
at
the
following
EPA
internet
site:

http://
www.
epa.
gov/
opprd001/
forms/.

Pesticide
Registration
Forms
(
These
forms
are
in
PDF
format
and
require
the
Acrobat
reader)

Instructions
1.
Print
out
and
complete
the
forms.
(
Note:
Form
numbers
that
are
bolded
can
be
filled
out
on
your
computer
then
printed.)

2.
The
completed
form(
s)
should
be
submitted
in
hardcopy
in
accord
with
the
existing
policy.

3.
Mail
the
forms,
along
with
any
additional
documents
necessary
to
comply
with
EPA
regulations
covering
your
request,
to
the
address
below
for
the
Document
Processing
Desk.

DO
NOT
fax
or
e­
mail
any
form
containing
'
Confidential
Business
Information'
or
'
Sensitive
Information.'

If
you
have
any
problems
accessing
these
forms,
please
contact
Nicole
Williams
at
(
703)
308­
5551
or
by
e­
mail
at
williams.
nicole@
epamail.
epa.
gov.

The
following
Agency
Pesticide
Registration
Forms
are
currently
available
via
the
internet:
at
the
following
locations:

8570­
1
Application
for
Pesticide
Registration/
Amendment
http://
www.
epa.
gov/
opprd001/
forms/
8570­
1.
pdf.

8570­
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf.

8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
8570­
5.
pdf.

8570­
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
8570­
17.
pdf.

8570­
25
Application
for/
Notification
of
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
http://
www.
epa.
gov/
opprd001/
forms/
8570­
25.
pdf.

8570­
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
8570­
27.
pdf.

8570­
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
8570­
28.
pdf.

8570­
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
8570­
30.
pdf.

8570­
32
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
8570­
32.
pdf.
124
8570­
34
Certification
with
Respect
to
Citations
of
Data
(
in
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf.

8570­
35
Data
Matrix
(
in
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf.

8570­
36
Summary
of
the
Physical/
Chemical
Properties
(
in
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf.

8570­
37
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
in
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf.

Pesticide
Registration
Kit
www.
epa.
gov/
pesticides/
registrationkit/.

Dear
Registrant:

For
your
convenience,
we
have
assembled
an
online
registration
kit
which
contains
the
following
pertinent
forms
and
information
needed
to
register
a
pesticide
product
with
the
U.
S.
Environmental
Protection
Agency's
Office
of
Pesticide
Programs
(
OPP):

1.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
as
Amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

2.
Pesticide
Registration
(
PR)
Notices
a.
83­
3
Label
Improvement
Program­­
Storage
and
Disposal
Statements
b.
84­
1
Clarification
of
Label
Improvement
Program
c.
86­
5
Standard
Format
for
Data
Submitted
under
FIFRA
d.
87­
1
Label
Improvement
Program
for
Pesticides
Applied
through
Irrigation
Systems
(
Chemigation)

e.
87­
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90­
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95­
2
Notifications,
Non­
notifications,
and
Minor
Formulation
Amendments
h.
98­
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(
This
document
is
in
PDF
format
and
requires
the
Acrobat
reader.)

Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices.

3.
Pesticide
Product
Registration
Application
Forms
(
These
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader.)

a.
EPA
Form
No.
8570­
1,
Application
for
Pesticide
Registration/
Amendment
b.
EPA
Form
No.
8570­
4,
Confidential
Statement
of
Formula
125
c.
EPA
Form
No.
8570­
27,
Formulator's
Exemption
Statement
d.
EPA
Form
No.
8570­
34,
Certification
with
Respect
to
Citations
of
Data
e.
EPA
Form
No.
8570­
35,
Data
Matrix
4.
General
Pesticide
Information
(
Some
of
these
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader.)

a.
Registration
Division
Personnel
Contact
List
I.
b.
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
Contacts
c.
Antimicrobials
Division
Organizational
Structure/
Contact
List
d.
53
F.
R.
15952,
Pesticide
Registration
Procedures;
Pesticide
Data
Requirements
(
PDF
format)

e.
40
CFR
Part
156,
Labeling
Requirements
for
Pesticides
and
Devices
(
PDF
format)

f..
40
CFR
Part
158,
Data
Requirements
for
Registration
(
PDF
format)

g..
50
F.
R.
48833,
Disclosure
of
Reviews
of
Pesticide
Data
(
November
27,
1985)

Before
submitting
your
application
for
registration,
you
may
wish
to
consult
some
additional
sources
of
information.
These
include:

1.
The
Office
of
Pesticide
Programs'
Web
Site
2.
The
booklet
"
General
Information
on
Applying
for
Registration
of
Pesticides
in
the
United
States",
PB92­
221811,
available
through
the
National
Technical
Information
Service
(
NTIS)
at
the
following
address:

National
Technical
Information
Service
(
NTIS)
5285
Port
Royal
Road
Springfield,
VA
22161
The
telephone
number
for
NTIS
is
(
703)
605­
6000.

3.
The
National
Pesticide
Information
Retrieval
System
(
NPIRS)
of
Purdue
University's
Center
for
Environmental
and
Regulatory
Information
Systems.
This
service
does
charge
a
fee
for
subscriptions
and
custom
searches.
You
can
contact
NPIRS
by
telephone
at
(
765)
494­
6614
or
through
their
Web
site.

4.
The
National
Pesticide
Telecommunications
Network
(
NPTN)
can
provide
information
on
active
ingredients,
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPTN
by
telephone
at
(
800)
858­
7378
or
through
their
Web
site:
ace.
orst.
edu/
info/
nptn.
126
The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,
or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
selfaddressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

 
Date
of
receipt;
 
EPA
identifying
number;
and
 
Product
Manager
assignment.

Other
identifying
information
may
be
included
by
the
applicant
to
link
the
acknowledgment
of
receipt
to
the
specific
application
submitted.
EPA
will
stamp
the
date
of
receipt
and
provide
the
EPA
identifying
File
Symbol
or
petition
number
for
the
new
submission.
The
identifying
number
should
be
used
whenever
you
contact
the
Agency
concerning
an
application
for
registration,
experimental
use
permit,
or
tolerance
petition.

To
assist
us
in
ensuring
that
all
data
you
have
submitted
for
the
chemical
are
properly
coded
and
assigned
to
your
company,
please
include
a
list
of
all
synonyms,
common
and
trade
names,
company
experimental
codes,
and
other
names
which
identify
the
chemical
(
including
"
blind"
codes
used
when
a
sample
was
submitted
for
testing
by
commercial
or
academic
facilities).
Please
provide
a
chemical
abstract
system
(
CAS)
number
if
one
has
been
assigned.

Documents
Associated
with
this
RED
The
following
documents
are
part
of
the
Administrative
Record
for
this
RED
document
and
may
be
included
in
the
EPA's
Office
of
Pesticide
Programs
Public
Docket.
Copies
of
these
documents
are
not
available
electronically,
but
may
be
obtained
by
contacting
the
person
listed
on
the
respective
Chemical
Status
Sheet.

1.
Health
Effects
Division
and
Environmental
Fate
and
Effects
Division
Science
Chapters,
which
include
the
complete
risk
assessments
and
supporting
documents.

2.
Detailed
Label
Usage
Information
System
(
LUIS)
Report.
