Document ID: EPA-HQ-OPP-2005-0497-0034
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-23T16:58:07Z

United
States
Prevention,
Pesticides
EPA
738R­
06­
027
Environmental
Protection
and
Toxic
Substances
July
2006
Agency
(
7508P)

Reregistration
Eligibility
Decision
(
RED)
for
Propiconazole
REREGISTRATION
ELIGIBILITY
DECISION
for
Propiconazole
Case
No.
3125
List
C
Approved
by:

/
S/

______________________
Debra
Edwards,
Ph.
D.
Director,
Special
Review
and
Reregistration
Division
July
18,
2006
________________________
Date
TABLE
OF
CONTENTS
Propiconazole
Reregistration
Eligibility
Decision
Team....................................................................
i
Glossary
of
Terms
and
Abbreviations................................................................................................
ii
ABSTRACT..........................................................................................................................................
1
I.
Introduction..................................................................................................................................
1
II.
Chemical
Overview......................................................................................................................
2
A.
Regulatory
History
..................................................................................................................
2
B.
Chemical
Identification
...........................................................................................................
3
1.
Propiconazole
.......................................................................................................................
3
2.
Free
Triazole
Metabolites
...................................................................................................
4
C.
Use
Profile.................................................................................................................................
5
D.
Estimated
Usage
of
Propiconazole..........................................................................................
6
III.
Summary
of
Propiconazole
Risk
Assessments
......................................................................
7
A.
Human
Health
Risk
Assessment.............................................................................................
8
1.
Toxicity
of
Propiconazole
and
the
Free
Triazoles.............................................................
9
2.
Carcinogenicity
..................................................................................................................
16
3.
Endocrine
Effects...............................................................................................................
17
4.
Factors
Considered
in
EPA's
Aggregate
Assessment.....................................................
17
5.
Aggregate
Risk
Assessment
for
Propiconazole
and
Free
Triazoles...............................
21
6.
Occupational
Exposure
and
Risk.....................................................................................
26
B.
Environmental
Fate
and
Effects
Risk
Assessment..............................................................
39
1.
Environmental
Fate
and
Transport
.................................................................................
40
2.
Ecological
Exposure
and
Risk
..........................................................................................
40
3.
Endangered
Species...........................................................................................................
53
4.
Ecological
Incidents
...........................................................................................................
54
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
.....................................
55
A.
Determination
of
Reregistration
Eligibility
.........................................................................
55
B.
Public
Comments
and
Responses
.........................................................................................
55
C.
Regulatory
Position................................................................................................................
56
1.
Food
Quality
Protection
Act
Findings
.............................................................................
56
2.
Endocrine
Disruptor
Effects
.............................................................................................
57
3.
Cumulative
Risks...............................................................................................................
58
D.
Tolerance
Reassessment
Summary
......................................................................................
58
1.
Tolerance
Definition..........................................................................................................
58
2.
Tolerance
Reassessment
Summary..................................................................................
59
3.
Codex
Harmonization
.......................................................................................................
65
4.
Residue
Analytical
Method...............................................................................................
66
E.
Regulatory
Rationale.............................................................................................................
66
1.
Human
Health
Risk
Management
...................................................................................
67
2.
Non­
Target
Organism
(
Ecological)
Risk
Management..................................................
70
3.
Summary
of
Mitigation
Measures....................................................................................
74
F.
Other
Labeling
Requirements
..............................................................................................
75
1.
Endangered
Species
Considerations
................................................................................
75
2.
Spray
Drift
Management..................................................................................................
76
A.
Manufacturing
Use
Products................................................................................................
77
1.
Generic
Data
Requirements..............................................................................................
77
2.
Labeling
for
Manufacturing
Use
Products......................................................................
78
B.
End­
Use
Products
..................................................................................................................
79
1.
Additional
Product­
Specific
Data
Requirements............................................................
79
2.
Labeling
for
End­
Use
Products
........................................................................................
79
C.
Labeling
Changes
Summary
Table......................................................................................
79
D.
Existing
Stocks
.......................................................................................................................
79
VI.
APPENDICES........................................................................................................................
88
i
Propiconazole
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs
Biological
and
Economic
Analysis
Assessment
Jenna
Carter
Tara
Chan­
Goyal
Environmental
Fate
and
Effects
Risk
Assessment
Ed
Odenkirchen
Bill
Evans
James
Lin
Thuy
Nguyen
Health
Effects
Risk
Assessment
Mike
Doherty
Yan
Donovan
Monica
Hawkins
David
Hrdy
Abdallah
Khasawinah
James
Scott
Miller
Antimicrobial
Team
Support
Tim
Leighton
Cassi
Walls
Stacey
Grigsby
Diane
Isbell
Registration
Support
Robert
Tomerlin
Tamue
Gibson
Mary
Waller
Risk
Management
Christina
Scheltema
Kimberly
Nesci
Kevin
Costello
Office
of
General
Counsel
Erin
Koch
ii
Glossary
of
Terms
and
Abbreviations
a.
i.
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
APHIS
Animal
and
Plant
Health
Inspection
Service
ARTF
Agricultural
Re­
entry
Task
Force
BCF
Bioconcentration
Factor
CDC
Centers
for
Disease
Control
CDPR
California
Department
of
Pesticide
Regulation
CFR
Code
of
Federal
Regulations
ChEI
Cholinesterase
Inhibition
CMBS
Carbamate
Market
Basket
Survey
cPAD
Chronic
Population
Adjusted
Dose
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
CWS
Community
Water
System
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DL
Double
layer
clothing
{
i.
e.,
coveralls
over
SL}
DWLOC
Drinking
Water
Level
of
Comparison
EC
Emulsifiable
Concentrate
Formulation
EDSP
Endocrine
Disruptor
Screening
Program
EDSTAC
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
EEC
Estimated
Environmental
Concentration.
The
estimated
pesticide
concentration
in
an
environment,
such
as
a
terrestrial
ecosystem.
EP
End­
Use
Product
EPA
U.
S.
Environmental
Protection
Agency
EXAMS
Tier
II
Surface
Water
Computer
Model
FDA
Food
and
Drug
Administration
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FOB
Functional
Observation
Battery
FQPA
Food
Quality
Protection
Act
FR
Federal
Register
GL
With
gloves
GPS
Global
Positioning
System
HIARC
Hazard
Identification
Assessment
Review
Committee
IDFS
Incident
Data
System
IGR
Insect
Growth
Regulator
IPM
Integrated
Pest
Management
RED
Reregistration
Eligibility
Decision
LADD
Lifetime
Average
Daily
Dose
LC50
Median
Lethal
Concentration.
Statistically
derived
concentration
of
a
substance
expected
to
cause
death
in
50%
of
test
animals,
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LCO
Lawn
Care
Operator
LD50
Median
Lethal
Dose.
Statistically
derived
single
dose
causing
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation),
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOAEC
Lowest
Observed
Adverse
Effect
Concentration
LOAEL
Lowest
Observed
Adverse
Effect
Level
LOC
Level
of
Concern
LOEC
Lowest
Observed
Effect
Concentration
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
MOE
Margin
of
Exposure
MP
Manufacturing­
Use
Product
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
iii
N/
A
Not
Applicable
NASS
National
Agricultural
Statistical
Service
NAWQA
USGS
National
Water
Quality
Assessment
NMFS
National
Marine
Fisheries
Service
NOAEC
No
Observed
Adverse
Effect
Concentration
NOAEL
No
Observed
Adverse
Effect
Level
NPIC
National
Pesticide
Information
Center
OPP
EPA
Office
of
Pesticide
Programs
ORETF
Outdoor
Residential
Exposure
Task
Force
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDCI
Product
Specific
Data
Call­
In
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
PRZM
Pesticide
Root
Zone
Model
RBC
Red
Blood
Cell
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RPA
Reasonable
and
Prudent
Alternatives
RPM
Reasonable
and
Prudent
Measures
RQ
Risk
Quotient
RTU
(
Ready­
to­
use)
RUP
Restricted
Use
Pesticide
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SL
Single
layer
clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
STORET
Storage
and
Retrieval
TEP
Typical
End­
Use
Product
TGAI
Technical
Grade
Active
Ingredient
TRAC
Tolerance
Reassessment
Advisory
Committee
TTRs
Transferable
Turf
Residues
UF
Uncertainty
Factor
USDA
United
States
Department
of
Agriculture
USFWS
United
States
Fish
and
Wildlife
Service
USGS
United
States
Geological
Survey
WPS
Worker
Protection
Standard
1
ABSTRACT
The
Environmental
Protection
Agency
(
EPA
or
the
Agency)
has
completed
the
human
health
and
environmental
risk
assessments
for
propiconazole
and
is
issuing
its
risk
management
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
registered
products
and
additional
information
received
through
the
public
docket.
After
considering
the
risks
identified
in
the
revised
risk
assessments,
comments
received,
and
mitigation
suggestions
from
interested
parties,
the
Agency
developed
its
risk
management
decision
for
uses
of
propiconazole
that
pose
risks
of
concern.
As
a
result
of
this
review,
EPA
has
determined
that
propiconazole­
containing
products
are
eligible
for
reregistration,
provided
that
risk
mitigation
measures
are
adopted
and
labels
are
amended
accordingly.
That
decision
is
discussed
fully
in
this
document.

I.
Introduction
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
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
U.
S.
Environmental
Protection
Agency
(
referred
to
as
EPA
or
"
the
Agency").
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
hazards
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
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
and
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
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
of
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
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,
FQPA
requires
EPA
to
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
chemicals
causing
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
one
of
these
individual
chemicals.
Propiconazole
belongs
to
a
group
of
pesticides
called
triazoles
(
or
conazoles),
which
also
includes
the
triazole
fungicides
subject
to
reregistration,
triadimefon
and
triadimenol.
For
the
purpose
of
this
reregistration
eligibility
decision
(
RED),
EPA
has
concluded
that
propiconazole
does
not
share
a
common
mechanism
of
toxicity
with
other
substances.
However,
the
triazole
fungicides
share
common
metabolites,
the
free
triazole
compounds
1,2,4­
triazole,
triazole
2
alanine,
and
triazole
acetic
acid,
which
are
considered
in
this
RED.
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
(
OPP)
concerning
common
mechanism
determinations
and
procedures
for
evaluating
cumulative
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

Propiconazole
also
shares
a
common
metabolite,
1,2,4­
triazole,
with
several
triazolederivative
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
is
working
with
the
U.
S.
Food
and
Drug
Administration
(
FDA),
which
has
regulatory
authority
for
drug
products,
to
assess
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
exposures
from
one
or
both
sources
of
1,2,4­
triazole
residues.

This
document
presents
EPA's
revised
human
health
and
ecological
risk
assessments,
its
progress
toward
tolerance
reassessment,
and
the
reregistration
eligibility
decision
for
propiconazole.
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
chemical;
Section
III
gives
an
overview
of
the
human
health
and
environmental
effects
risk
assessments;
Section
IV
presents
the
Agency's
decision
on
reregistration
eligibility
and
risk
management;
and
Section
V
summarizes
the
label
changes
necessary
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV.
Finally,
the
Appendices
list
related
information,
supporting
documents,
and
studies
evaluated
for
the
reregistration
decision.
The
revised
risk
assessments
for
propiconazole
are
available
in
the
OPP
docket
and
in
the
Agency's
electronic
docket
on
the
internet
at
http://
www.
regulations.
gov
under
docket
number
EPA­
HQ­
OPP­
2005­
0497.

II.
Chemical
Overview
A.
Regulatory
History
Propiconazole
was
first
registered
in
1981
by
Ciba
Geigy
for
use
on
grass
grown
for
seed.
The
Agency
approved
additional
uses
on
sugarcane,
pecan,
cereal
grains,
rice,
and
bananas
(
import
only)
in
1987
and
tolerances
were
established
for
these
commodities.
Additional
food
uses
on
celery,
stone
fruit,
and
wild
rice
were
approved
by
EPA
in
1993,
and
uses
on
corn,
pineapple
and
peanuts
were
approved
in
1994.
Novartis
became
the
technical
registrant
for
propiconazole
in
1996,
after
the
merger
of
Ciba
Geigy
and
Sandoz.
Syngenta,
one
of
the
current
technical
registrants,
acquired
propiconazole
in
2000
as
the
result
of
a
merger
of
Novartis
and
Zeneca.

Today,
propiconazole
is
registered
for
use
on
numerous
food
and
feed
crops;
55
permanent
and
15
temporary
tolerances
have
been
established.
Propiconazole
is
also
registered
for
use
on
turf
and
ornamentals
and
for
use
as
a
wood
preservative.
The
Agency
has
approved
FIFRA
Section
24c
Special
Local
Need
registrations
for
propiconazole
on
mint,
sunflower
grown
for
seed,
nonbearing
blueberries,
sugarcane
seed
pieces,
wheat,
corn,
bananas,
and
nonbearing
hazelnuts.
EPA
has
also
approved
FIFRA
Section
18
Emergency
Exemptions
for
propiconazole
on
dry
bean,
sorghum,
3
blueberries,
cranberries,
and
raspberries.
Although
the
registrant
has
submitted
petitions
to
the
Agency
for
additional
food
uses,
these
have
not
been
considered
as
part
of
this
reregistration
eligibility
decision
(
RED)
and
will
be
addressed
by
the
Agency
at
a
later
time
as
a
separate
decision.

Propiconazole
is
also
registered
for
use
as
an
antimicrobial
pesticide
by
Janssen
Pharmaceutica;
the
first
antimicrobial
product
was
registered
in
1996.
Today
propiconazole
is
used
in
material
preservation
and
wood
preservation
products.
As
a
materials
preservative,
propiconazole
is
used
in
items
such
as
metalworking
fluids,
adhesives,
caulks,
coatings,
stains,
paints,
inks,
paper,
textiles,
canvas,
cordage,
leather,
and
leather
finishing
pastes,
fat
liquors,
or
finishes.
The
two
major
registrants,
Syngenta
and
Janssen,
have
requested
amendments
to
their
propiconazole
registrations
deleting
use
for
treatment
of
carpet
fibers,
apparel,
and
furnishings1.
The
primary
textile
use
includes
"
canvas"
(
i.
e.,
awnings,
boat
covers,
carpet
backing,
cordage,
tents,
tarpaulins,
and
wall
coverings).
As
a
wood
preservative,
the
products
can
be
used
on
green
or
fresh
cut
lumber,
poles,
posts,
and
timbers;
manufactured
wood
products
such
as
logs
(
such
as
those
used
in
the
construction
of
log
homes),
wood
chips/
sawdust,
plywood
veneer,
and
particle
board;
dry
lumber;
and
finished
wood
products
such
as
millwork,
shingles,
shakes,
siding,
plywood,
and
structural
lumber
and
composites.
The
majority
of
the
products
are
intended
for
use
at
wood
treatment
facilities;
however,
propiconazole
is
also
formulated
for
use
in
mushroom
houses,
to
protect
timber
trays
and
benches,
and
for
use
on
wood
in
cooling
towers.

Because
propiconazole
is
on
List
C
of
Reregistration
Priorities,
EPA
did
not
complete
a
Registration
Standard.
However,
two
Data
Call­
Ins
(
DCIs)
were
issued
for
propiconazole
on
September
30,
1993
and
January
4,
1994.
Generic
data
requirements
necessary
to
complete
reregistration
included
environmental
fate
and
effects
studies,
product
and
residue
chemistry
studies,
and
avian,
fish,
invertebrate,
and
mammalian
toxicity
studies.
Propiconazole
was
also
included
in
the
Agricultural
Re­
entry
DCI
issued
on
October
6,
1995
for
worker
dermal
and
inhalation
exposure
monitoring
and
foliar
residue
dissipation
studies.

B.
Chemical
Identification
1.
Propiconazole
Chemical
Structure:

Cl
Cl
O
O
N
N
N
CH
3
Common
Name:
Propiconazole
Chemical
Name:
1­((
2­(
2,4­
Dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl)
methyl)­
1H­
1,2,4­

1
EPA
published
a
Notice
of
this
request
in
the
Federal
Register
on
March
8,
2006
(
71FR11622)
and
issued
an
order
amending
propiconazole
registrations
on
May
26,
2006.
4
triazole
Trade
Name:
Tilt,
Alamo
®
,
Banner
®
,
Orbit
®
,
and
Quilt
 
Chemical
Family:
Triazole,
Conazole
Case
Number:
3125
CAS
Number:
60207­
90­
1
PC
Code:
122101
Molecular
Weight:
342.23
Empirical
Formula:
C15H17Cl2N3O2
Basic
Manufacturer:
Janssen
Pharmaceutica,
Inc.;
Syngenta
Crop
Protection
Other
Technical
Registrants:
Dow
AgroSciences;
Irvita
Plant
Protection;
Makteshim­
Agan
2.
Free
Triazole
Metabolites
Propiconazole
and
other
triazole
fungicides
are
metabolized
in
animals
and
plants
to
form
compounds
containing
the
triazole
moiety
(
free
triazole
metabolites),
including
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid,
which
are
also
considered
in
this
decision.
Because
triazole
alanine
and
triazole
acetic
acid
are
formed
by
conjugation
with
an
amino
acid,
they
are
referred
to
as
triazole
conjugates
throughout
this
document.
Chemical
information
for
these
triazole
metabolites
is
provided
below.

a.
1,2,4­
Triazole
NH
N
N
Chemical
Name:
1,2,4­
Triazole
Common
Names:
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
5
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
C.
Use
Profile
The
following
is
information
on
the
currently
registered
uses
of
propiconazole,
including
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
propiconazole
eligible
for
reregistration
is
available
in
Appendix
A.

Type
of
Pesticide:
Fungicide,
Antimicrobial
Target
Pest:
Bacteria,
fungi,
viruses
(
plant
pathogens
and
spoilage
agents)

Mode
of
Action:
Inhibits
an
enzyme
involved
in
ergosterol
biosynthesis,
which
is
critical
to
the
formation
of
the
cell
walls
in
fungi,
thereby
slowing
or
stopping
fungal
growth.

Use
Sites:
Propiconazole
is
used
on
a
number
of
agricultural
crops,
fruit
and
nut
trees,
ornamentals,
and
turf.
Propiconzole
is
also
used
as
a
wood
preservative
and
as
an
antimicrobial/
material
preservative
in
adhesives,
paints,
coatings,
leather,
paper;
textiles,
and
specialty
industrial
products.

Terrestrial
Food
and
Feed
Uses:
Banana;
Barley;
Celery;
Dry
beans
and
peas;
Field
corn,
Sweet
corn,
and
Popcorn;
Filbert;
Pecan;
Plantain;
Stone
fruits;
Sunflower;
Wheat;
Barley;
Cereal
grains;
Citrus;
Kumquat;
Lemon;
Lime;
Mint;
Oats;
Orange;
Peanuts,
Pineapple
(
seed
piece
treatment);
Rice
and
Wild
rice;
Rye;
Sugarcane;
Tangerine;
Tree
nuts;
Triticale;
Wheat
Terrestrial
NonFood
Uses:
Turf,
including
golf
courses
and
sod
farms;
Ornamentals;
Nonbearing
citrus,
fruit,
and
nut
trees
Antimicrobial
Uses:
Adhesives,
Coatings,
Paints,
Wood
preservative
Use
Classification:
General
Use
6
Formulation
Types:
Emulsifiable
concentrate,
Flowable
concentrate,
Liquid
ready­
to­
use,
Liquid
soluble
concentrate,
Wettable
powder,
Dust
Application
Methods:
Band
treatment;
Chemigation;
Dip
treatment;
Directed
spray;
Ground
spray;
Hides
and
skins
treatment;
High
volume
spray
(
dilute);
Industrial
preservative
treatment;
Injection
treatment;
Low
volume
spray
(
concentrate);
Soak;
Spray;
Tree
injection
treatment;
Wood
protection
treatment
by
pressure;
Wood
surface
treatment
Application
Rates:
Propiconazole
application
rates
vary
by
use.
For
most
agricultural
uses,
propiconazole
is
applied
at
less
than
1
pound
active
ingredient
per
acre
(
lb
ai/
A)
for
crops,
but
it
may
be
applied
at
up
to
1.8
lb
ai/
A
for
turf
and
ornamentals.
Antimicrobial
end­
use
products
contain
propiconazole
at
concentrations
ranging
from
0.1
to
50%
ai.
Maximum
concentrations
for
various
antimicrobial
uses
are
0.65%
ai
solution
for
an
open
dip
tank,
0.8%
ai
solution
for
conventional
spray,
and
50%
ai
solution
for
electrostatic
spray.

Application
Timing:
At
bud
break;
At
emergence;
At
pegging;
Bloom;
Boot;
Crown;
Delayed
dormant;
Dormant;
Early
bloom;
Early
fall;
Early
spring;
Early
summer;
Fall;
Foliar;
Internode
elongation;
Late
fall;
Late
spring;
Late
winter;
May;
Nonbearing;
Nonbearing
nurserystock;
Not
on
label;
Nurserystock;
Petal
fall;
Petal
fall
through
foliar;
Pink;
Popcorn;
Postplant;
Prebloom;
Precutting;
Preharvest;
Preplant;
Seed
piece;
Seedling
stage;
Shock/
slug;
Spring;
Summer;
Tillering;
When
needed;
Winter
D.
Estimated
Usage
of
Propiconazole
A
screening­
level
estimate
of
the
usage
of
propiconazole
indicates
that
approximately
345,000
pounds
of
propiconazole
active
ingredient
(
ai)
were
used
annually
from
1999
to
2004.
A
five
year
average
was
calculated
using
EPA
source
data
and
data
from
the
US
Department
of
Agriculture's
(
USDA)
National
Agricultural
Statistics
Service
(
NASS)
for
the
years
2000
to
2004.
These
data
are
presented
in
Table
1
below.

Table
1.
National
Agricultural
Usage
of
Propiconazole
 
Highest
Use
Sites
Crop
Average
Annual
Amount
Used
(
lbs.
a.
i.)
Average
Annual
Total
Area
Treated
(
A)
Average
Annual
Percent
Crop
Treated
Almonds
830
8,000
>
5
Apples
33
300
>
1
Apricots
840
8,100
29
Barley
11,000
150,000
3
Celery
2,500
23,000
49
Cherries
3,900
36,000
18
7
Table
1.
National
Agricultural
Usage
of
Propiconazole
 
Highest
Use
Sites
Crop
Average
Annual
Amount
Used
(
lbs.
a.
i.)
Average
Annual
Total
Area
Treated
(
A)
Average
Annual
Percent
Crop
Treated
Dry
Beans/
Peas
560
5,300
51
Filberts
1,500
8,500
19
Peaches
12,000
110,000
31
Peanuts
48,000
810,000
73
Pecans
38,000
410,000
18
Prunes
4,400
40,000
18
Rice
58,000
420,000
55
Sweet
Corn
15,000
140,000
11
Wheat,
Spring
57,000
780,000
56
Wheat,
Winter
91,000
940,000
62
EPA
Source
Data
and
USDA
NASS
(
2000­
2004)

III.
Summary
of
Propiconazole
Risk
Assessments
The
following
is
a
summary
of
EPA's
human
health
and
ecological
effects
risk
assessments
for
propiconazole,
as
presented
fully
in
the
following
documents:

 
Propiconazole:
Phase
4,
HED
Chapter
of
the
Re­
registration
Eligibility
Decision
Document
(
RED).
June
28,
2006
 
Revised
Drinking
Water
Assessment
of
Propiconazole.
June
7,
2006
 
Propiconazole:
Revised
Occupational
and
Residential
Exposure
Assessment
of
the
Antimicrobial
Uses
to
Support
the
Reregistration
Eligibility
Decision
(
RED)
Document.
February
1,
2006.
 
Propiconazole:
Amendment
to
the
Propiconazole
Reregistration
Eligibility
Decision
(
RED)
Document
for
Children's
Postapplication
Exposure
Treated
Structures.
June
20,
2006
 
Environmental
Fate
and
Effects
Division
Revised
RED
for
the
Reregistration
of
Propiconazole.
June
30,
2006
Risks
for
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid
are
considered
in
this
RED
because
they
are
common
metabolites
of
propiconazole
and
other
triazole
fungicides.
The
purpose
if
this
summary
is
to
assist
the
reader
by
identifying
the
key
features
and
findings
of
these
risk
assessments,
and
to
help
the
reader
better
understand
the
conclusions
reached
in
the
assessments.

The
human
health
and
ecological
risk
assessment
documents
and
supporting
information
listed
in
Appendix
C
were
used
to
reach
the
safety
finding
and
regulatory
decision
for
propiconazole.
Although
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
from
the
OPP
Public
Docket
OPP­
2005­
0497
and
may
also
be
accessed
on
the
website
www.
regulations.
gov.
Hard
copies
of
these
documents
may
be
found
in
the
OPP
public
docket
under
this
same
docket
number.
8
A.
Human
Health
Risk
Assessment
EPA
released
its
preliminary
risk
assessments
for
propiconazole,
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid
for
public
comment
on
February
15,
2006
for
a
60­
day
public
comment
period
(
Phase
3
of
the
public
participation
process).
The
preliminary
risk
assessments
may
be
found
in
the
OPP
public
docket
at
the
address
given
above
and
on
the
website
www.
regulations.
gov.
In
response
to
comments
received
and
new
studies
submitted
during
Phase
3,
the
risk
assessments
were
updated
and
refined.
The
human
health
risk
assessment
for
propiconazole
was
revised
on
June
28,
2006,
to
incorporate
comments
and
additional
studies
submitted
by
the
registrant.
In
addition,
the
Agency
is
considering
late
comments
on
the
1,2,4­
triazole
risk
assessment
which
may
allow
EPA
to
refine
the
risk
assessments
for
the
free
triazoles.
However,
because
these
risk
assessment
refinements
are
not
expected
to
alter
the
conclusions
of
the
propiconazole
RED,
they
are
not
incorporated
into
this
decision
document.
The
Agency's
use
of
human
studies
in
the
propiconazole
risk
assessment
is
in
accordance
with
the
Agency's
Final
Rule
promulgated
on
January
26,
2006,
related
to
Protections
for
Subjects
in
Human
Research,
which
is
codified
in
40
CFR
Part
26.

Revised
risk
assessments
for
propiconazole
may
be
found
in
the
OPP
dockets
under
docket
number
OPP­
2005­
0497.
Major
revisions
to
the
risk
assessment
include
the
following:

 
Revision
of
estimated
drinking
water
concentrations
(
EDWCs)
used
in
the
dietary
risk
assessment;
 
Incorporation
of
new
drinking
estimates,
new
food
residue
estimates
for
rice
and
processed
commodities,
and
the
revised
FQPA
safety
factor
into
the
dietary
risk
assessment;
and
 
Consideration
of
post­
application
residential
risk
associated
with
use
of
propiconazole
as
a
wood
preservative
on
dimensional
lumber.

The
human
health
risk
assessment
incorporates
potential
exposure
from
all
sources,
which
include
food,
drinking
water,
residential
(
if
applicable),
and
occupational
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.
The
Agency's
human
health
assessment
is
protective
of
all
U.
S.
populations,
including
infants
and
young
children.

This
document
summarizes
risk
estimates
for
both
propiconazole
and
its
free
triazole
metabolites
1,2,4­
triazole,
triazole
alanline,
and
triazole
acetic
acid.
Propiconazole
and
the
other
triazole
fungicides
metabolize
to
these
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
aggregate
or
combined
risks
from
food,
drinking
water
and
non­
occupational
exposure
resulting
from
propiconazole
alone
and
from
the
free
triazoles
from
all
sources.
In
addition,
EPA
has
also
considered
potential
co­
exposure
to
free
triazoles
resulting
from
pharmaceutical
uses
of
triazole
compounds.
The
aggregate
risk
from
all
sources
of
the
free
triazoles
must
be
considered
to
reassess
the
tolerances
for
propiconazole
in
accordance
with
FQPA.
Because
the
risks
associated
with
the
free
triazoles
are
all
below
the
Agency's
level
of
concern,
they
are
not
addressed
in
as
much
detail
as
the
risks
from
propiconazole.
Additional
details
regarding
the
risks
associated
with
the
free
triazoles
may
be
found
in
the
February
3,
2006
document,
1,2,4­
Triazole,
Triazole
Alanine,
Triazole
Acetic
Acid:
9
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
0497).

1.
Toxicity
of
Propiconazole
and
the
Free
Triazoles
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
effects,
or
reproductive
effects),
and
the
level
or
dose
at
which
such
effects
might
occur.
The
Agency
has
reviewed
all
toxicity
studies
submitted
for
propiconazole
and
has
determined
that
the
toxicological
database
is
complete,
reliable,
and
sufficient
for
reregistration.
For
more
details
on
the
toxicity
of
propiconazole,
see
the
January
27,
2006
document,
Propiconazole
 
Hazard
Characterization
Assessment
for
the
Reregistration
Eligibility
Decision,
which
is
available
under
docket
number
EPA­
HQ­
OPP­
2005­
0497.

As
previously
mentioned,
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
propiconazole.
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
and
TRIAZOLES
 
2nd
Report
of
the
Ad
Hoc
HED
Peer
Review
Committee,
which
is
available
under
docket
number
EPA­
HQ­
OPP­
2005­
0497.

a.
Acute
Toxicity
Profile
for
Propiconazole
Propiconazole
is
classified
as
category
III
for
acute
oral
and
dermal
toxicity
and
as
category
IV
for
acute
inhalation
toxicity.
It
is
classified
as
category
III
for
eye
irritation
potential
and
category
IV
for
skin
irritation
potential.
Propiconazole
caused
dermal
sensitization
in
guinea
pigs.
The
acute
toxicity
profile
for
technical
grade
propiconazole
is
summarized
in
Table
2
below.
These
data
are
presented
only
to
provide
background
information
on
the
active
ingredient
and
may
not
be
appropriate
for
product
reregistration.
Additional
acute
toxicity
data
may
be
required
to
determine
appropriate
cautionary
label
language
for
products
containing
propiconazole.
Acute
toxicity
data
are
not
presented
for
the
free
triazoles
because
they
do
not
occur
in
pesticide
products,
and
thus
are
not
considered
in
product
labeling.
10
Table
2.
Acute
Toxicity
Profile
for
Propiconazole
Guideline
Study
Type
MRID
Results
Toxicity
Category
870.1100
Acute
Oral
 
Rat
00058591
LD50
=
1517
mg/
kg
III
870.1200
Acute
Dermal
­
Rabbit
0058596
LD50
 
4000
mg/
kg
III
870.1300
Acute
Inhalation
41594801
LC50
 
5.84
mg/
L
IV
870.2400
Primary
Eye
Irritation
00058598
Corneal
Opacity
reversed
in
72
hours
III
870.2500
Primary
Skin
Irritation
00058598
Non­
irritant
IV
870.2600
Dermal
Sensitization
44949501
Sensitizer
N/
A
LD50
or
LC50
­
Median
Lethal
Dose
or
Concentration,
statistically
derived
single
dose
or
concentration
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
N/
A
­
not
applicable.

b.
FQPA
Safety
Factor
Considerations
The
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA),
directs
the
Agency
to
use
an
additional
ten
fold
(
10X)
safety
factor
(
SF)
to
account
for
potential
pre­
and
postnatal
toxicity
and
completeness
of
the
data
with
respect
to
exposure
and
toxicity
to
infants
and
children.
FQPA
authorizes
the
Agency
to
modify
the
10X
FQPA
SF
only
if
reliable
data
demonstrate
that
the
resulting
level
of
exposure
would
be
safe
for
infants
and
children.

Propiconazole
The
Agency
has
reviewed
the
toxicology
database
for
propiconazole
and
concluded
that
it
is
adequate
to
characterize
any
potential
for
prenatal
or
postnatal
risk
for
infants
and
children.
The
requirement
for
a
developmental
neurotoxicity
study
in
propiconazole
was
waived
because
no
effects
were
seen
in
a
submitted
acute
neurotoxicity
study.
In
light
of
the
existing
toxicology
database
for
propiconazole,
EPA
concluded
that
there
is
low
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
propiconazole
and
that
there
are
no
residual
uncertainties.
Because
there
was
no
evidence
of
increased
susceptibility,
the
FQPA
SF
for
propiconazole
per
se
was
reduced
to
1X.
This
SF
also
considers
the
completeness
of
the
exposure
database
for
food,
drinking
water,
and
residential
exposure.
The
FQPA
SF
reflects
the
Agency's
confidence
that
the
risk
assessment
for
each
potential
exposure
scenario
includes
all
metabolites
and
degradates
of
concern
and
will
not
result
in
an
underestimate
of
dietary
or
residential
risks
to
infants
and
children.

Free
Triazoles
1,2,4­
Triazole.
EPA
has
reviewed
the
available
toxicology
studies
for
1,2,4­
triazole
and
determined
that
the
database
is
sufficient
to
conduct
an
FQPA
assessment
and
adequate
to
characterize
prenatal
and
postnatal
effects.
From
the
existing
toxicity
data,
the
Agency
has
concluded
that
there
are
low
residual
concerns
and
no
residual
uncertainties
with
regard
to
pre­
and/
or
postnatal
toxicity
of
11
1,2,4­
triazole.
However,
EPA
has
retained
a
10X
FQPA
SF
based
on
nervous
system
effects
and
database
uncertainties,
including
data
gaps
for
the
acute
and
developmental
neurotoxicity
studies.
(
A
developmental
neurotoxicity
study
is
required
for
1,2,4­
triazole.)
The
Agency
believes
that
the
exposure
estimates
for
1,2,4­
triazole
will
not
result
in
an
underestimation
of
either
dietary
or
residential
risks
to
infants
and
children.

Triazole
Conjugates
(
Triazole
Alanine
and
Triazole
Acetic
Acid).
For
the
triazole
conjugates,
triazole
alanine
and
triazole
acetic
acid,
the
toxicology
database
is
incomplete
to
characterize
increased
potential
increased
susceptibility
to
pre­
and
postnatal
effects.
However,
the
available
rat
developmental
toxicity
and
two­
generation
reproduction
studies
for
these
conjugates
showed
increased
qualitative
and
quantitative
susceptibility
of
the
offspring.
Therefore,
the
10X
FQPA
SF
is
retained
for
increased
susceptibility
and
database
uncertainties
(
data
gaps
for
rabbit
developmental
toxicity
studies
with
triazole
alanine
and
triazole
acetic
acid,
a
chronic
rat
study
with
triazole
alanine,
and
a
combined
90­
day/
subchronic
neurotoxicity
rat
study
for
triazole
acetic
acid).
Although
increased
qualitative
and
quantitative
susceptibility
of
the
offspring
was
seen
in
the
developmental
toxicity
and
two­
generation
reproduction
studies
in
rats,
the
currently
selected
dietary,
residential,
and
occupational
endpoints
are
all
based
on
no
observed
adverse
effects
levels
(
NOAELs)
that
are
protective
of
these
adverse
effects.
Additionally,
no
evidence
of
neurotoxicity
was
seen
in
the
available
toxicology
database,
so
a
developmental
neurotoxicity
study
is
not
being
required
at
this
time.
The
Agency
believes
that
the
exposure
estimates
for
the
triazole
conjugates
will
not
result
in
an
underestimation
of
either
dietary
or
residential
risks
to
infants
and
children.

c.
Toxicological
Endpoints
Propiconazole.
The
toxicological
endpoints
used
in
the
human
health
risk
assessment
for
propiconazole
are
listed
in
Table
3
below,
as
well
as
the
estimated
dermal
and
inhalation
absorption
factors
used
in
the
risk
assessment.
The
Agency
estimated
that
40%
of
an
applied
dose
of
propiconazole
is
absorbed
through
the
skin,
based
on
a
rat
dermal
absorption
study.
For
inhalation
exposure,
EPA
used
a
default
factor
of
100%
absorption.
The
uncertainty
factors
(
UF)
and
safety
factors
used
to
account
for
interspecies
extrapolation,
intraspecies
variability,
and
special
susceptibility
of
infants
and
children
(
FQPA
SF)
are
also
described
in
Table
3.

Table
3.
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Acute
Dietary
(
Females
age
13­
50)
NOAEL
=
30
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
Developmental
Toxicity
Study
­
Rats.
Increased
incidence
of
rudimentary
ribs,
cleft
palate
malformations
(
0.3%)
unossified
sternebrae,
as
well
as
increased
incidence
of
shortened
and
absent
renal
papillae
at
LOAEL
of
90
mg/
kg/
day.
12
Table
3.
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Acute
Dietary
(
General
Population
including
infants
and
children)
NOAEL
=
30
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
gait
at
LOAEL
of
100
mg/
kg/
day.

Chronic
Dietary
(
All
populations)
NOAEL
=
10
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.1
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.1
mg/
kg/
day
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity;
increased
liver
weight
in
males,
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas).
LOAEL
is
50
mg/
kg/
day.

Short­
Term
Incidental
Oral
(
1­
30
days)
NOAEL=
30
mg/
kg/
day
UF
=
100
FQPA
SF
=
1
Residential
LOC
for
MOE
is
100.
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
gait
at
LOAEL
is
100
mg/
kg/
day.

Intermediate­
Term
Incidental
Oral
(
1
­
6
months)
NOAEL=
10
mg/
kg/
day
UF
=
100
FQPA
SF
=
1
Residential
LOC
for
MOE
is
100.
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity;
increased
liver
weight
in
males,
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas)
).
LOAEL
is
50
mg/
kg/
day.

Short­
Term
Dermal
(
1
­
30
days)
(
general
population
including
infants
and
children)
Oral
NOAEL=
30
mg/
kg/
day
UF
=
100
(
Dermal
absorption
rate
=
40%)
FQPA
SF
=
1
Residential
LOC
for
MOE
is
100.

Occupational
LOC
for
MOE
is
100.
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
gait
at
LOAEL
of
100
mg/
kg/
day.

Intermediate­
(
1
­
6
months)
and
Long­
Term
Dermal
(>
6
months)
Oral
NOAEL=
10
mg/
kg/
day
UF
=
100
(
Dermal
absorption
rate
=
40%)
FQPA
SF
=
1
Residential
LOC
for
MOE
is
100.

Occupational
LOC
for
MOE
is
100.
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity;
ncreased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas).
13
Table
3.
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Short­
Term
Inhalation
(
1
­
30
days)
Oral
NOAEL=
30
mg/
kg/
day
UF
=
100
(
Inhalation
absorption
rate
=
100%)
FQPA
SF
=
1
Residential
LOC
for
MOE
is
100.

Occupational
LOC
for
MOE
is
100.
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
gait
at
LOAEL
of
100
mg/
kg/
day.
LOAEL
is
50
mg/
kg/
day.

Intermediate­
Term
(
1
­
6
months)
and
Long­
Term
Inhalation
(>
6
months)
Oral
NOAEL=
10
mg/
kg/
day
UF
=
100
(
Inhalation
absorption
rate
=
100%)
FQPA
SF
=
1
Residential
LOC
for
MOE
is
100;

Occupational
LOC
for
MOE
is
100.
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas)).
LOAEL
is
50
mg/
kg/
day.

Cancer
(
Oral,
dermal,
inhalation)
Classified
as
a
Group
C,
possible
human
carcinogen,
RfD
used
for
risk
characterization
because
the
chronic
RfD
is
protective
of
any
potential
carcinogenic
effects.

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.

Free
Triazoles.
The
toxicological
endpoints
used
in
the
assessment
for
the
free
triazoles
are
presented
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
docket
EPA­
HQ­
OPP­
2005­
0497.
The
toxicological
endpoints
used
in
the
human
health
risk
assessments
for
1,2,4­
triazole
and
the
conjugates
triazole
alanine
and
triazole
acetic
acid
are
summarized
in
Tables
4
and
5,
respectively.
Because
the
available
data
on
the
conjugates
are
limited,
the
Agency
has
assumed
that
all
conjugates
(
i.
e.,
triazole
alanine
and
trizole
acetic
acid)
are
toxicologically
equivalent.
For
both
dermal
and
inhalation
exposure,
EPA
assumed
that
100%
of
applied
dose
is
absorbed.
14
Table
4.
Toxicological
Doses
and
Endpoints
for
1,2,4­
Triazole
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Acute
Dietary
(
females
age
13­
49)
NOAEL
=
30
mg/
kg/
day
UF=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
10
aPAD
=
acute
RfD
FQPA
SF
=
0.03
mg/
kg/
day
Developmental
Toxicity
study
 
rabbits.
LOAEL
is
45
mg/
kg
based
on
urinary
tract
malformations
in
fetuses
Acute
Dietary
(
general
population
including
infants
and
children)
NOAEL
=
30
mg/
kg
UF=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
10
aPAD
=
acute
RfD
FQPA
SF
=
0.03
mg/
kg/
day
Developmental
Toxicity
study
 
rabbits.
LOAEL
is
45
mg/
kg
based
on
clinical
signs
and
mortality
in
does
starting
on
Gestation
Day
6
or
7
Chronic
Dietary
(
all
populations)
LOAEL
=
15
mg/
kg/
day
UF
=
300
Chronic
RfD
=
0.05
mg/
kg/
day
FQPA
SF
=
10
cPAD
=
chronic
RfD
FQPA
SF
=
0.005
mg/
kg/
day
Reproductive
Toxicity
study
 
rats.
LOAEL
is
15
mg/
kg/
day
based
on
decreased
body
weight
in
adult
males,
decreased
body
weight
and
brain
weight
in
offspring;
no
NOAEL
established
for
this
study
(
hence
additional
3X
UF).
Incidental
Oral
Shortterm
(
1­
30
days)
NOAEL
=
30
mg/
kg/
day
UF=
100
FQPA
SF
=
10
Residential
LOC
for
MOE
is
1000.
Developmental
Toxicity
study
 
rabbits.
LOAEL
is
45
mg/
kg/
day
based
on
clinical
signs
and
mortality
in
does
starting
on
Gestation
Day
6
or
7.
Incidental
Oral
Intermediate­
or
Long­
term
(
30
days
to
6
months)
LOAEL
=
15
mg/
kg/
day
UF
=
300
FQPA
SF
=
10
Residential
LOC
for
MOE
is
3000.
Reproductive
Toxicity
study
 
rats.
LOAEL
is
15
mg/
kg/
day
based
on
decreased
body
weight
in
adult
males,
decreased
body
weight
and
brain
weight
in
offspring;
no
NOAEL
established
for
this
study
(
hence
additional
3X
UF)..
Dermal
Short­
term
(
1­
30
days)
NOAEL
=
30
mg/
kg/
day
UF
=
100
FQPA
SF
=
10
Residential
LOC
for
MOE
is
1000.
Developmental
Toxicity
study
 
rabbits.
LOAEL
is
45
mg/
kg/
day
based
on
clinical
signs
and
mortality
in
does
starting
on
Gestation
Day
6
or
7.
Dermal
Intermediate­
or
Long­
term
(
30
days
to
6
months)
LOAEL
=
15
mg/
kg/
day
UF
=
300
FQPA
SF
=
10
Residential
LOC
for
MOE
is
3000.
Reproductive
Toxicity
study
­
rats.
LOAEL
is
15
mg/
kg/
day
based
on
decreased
body
weight
in
adult
males,
decreased
body
weight
and
brain
weight
in
offspring;
no
NOAEL
established
for
this
study
(
hence
additional
3X
UF).
15
Table
4.
Toxicological
Doses
and
Endpoints
for
1,2,4­
Triazole
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Inhalation
Short­
term
(
1
­
30
days)
NOAEL
=
30
mg/
kg/
day
UF
=
100
FQPA
SF
=
10
Residential
LOC
for
MOE
is
1000
Developmental
Toxicity
study
 
rabbits.
LOAEL
is
45
mg/
kg/
day
based
on
clinical
signs
and
mortality
in
does
starting
on
Gestation
Day
6
or
7
Inhalation
Intermediate­
or
Long­
term
(
30
days
to
6
months)
LOAEL
=
15
mg/
kg/
day
UF
=
300
FQPA
SF
=
10
Residential
LOC
for
MOE
is
3000.
Reproductive
Toxicity
study
­
rats.
LOAEL
is
15
mg/
kg/
day
based
on
decreased
body
weight
in
adult
males,
decreased
body
weight
and
brain
weight
in
offspring;
no
NOAEL
established
for
this
study
(
hence
additional
3X
UF).
Cancer
(
oral,
dermal,
inhalation)
Not
Classified
for
potential
carcinogenicity.
Any
potential
cancer
effects
would
be
covered
using
the
chronic
RfD.
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.

Table
5.
Toxicological
Doses
and
Endpoints
for
the
Triazole
Conjugates
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Acute
Dietary
(
females
13­
49)
NOAEL
=
100
mg/
kg/
day
UF
=
100
Acute
RfD
=
1
mg/
kg/
day
FQPA
SF
=
10
aPAD
=
acute
RfD
FQPA
SF
=
0.1
mg/
kg/
day
Prenatal
Developmental
Toxicity
 
rat
LOAEL
is
300
mg/
kg/
day
based
on
increased
incidence
of
skeletal
findings
(
unossified
odontoid
process).
Acute
Dietary
(
general
population,
including
infants
and
children)
None
None
No
appropriate
dose
and
endpoint
could
be
identified
for
these
population
groups.
Chronic
Dietary
(
all
populations)
NOAEL
=
90
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.9
mg/
kg/
day
FQPA
SF
=
10
cPAD
=
chronic
RfD
FQPA
SF
=
0.09
mg/
kg/
day
90­
Day
Oral
Toxicity
 
rat
LOAEL
is
370/
400
mg/
kg/
day
(
M/
F)
based
on
decreased
leukocyte
counts
in
males
and
decreased
triglycerides
in
females.

Incidental
Oral
(
all
durations)
NOAEL
=
90
mg/
kg/
day
UF
=
100
FQPA
SF
=
10
Residential
LOC
for
MOE
is
1000.
90­
Day
Oral
Toxicity
 
rat
LOAEL
is
370/
400
mg/
kg/
day
(
M/
F)
based
on
decreased
leukocyte
counts
in
males
and
decreased
triglycerides
in
females.
16
Table
5.
Toxicological
Doses
and
Endpoints
for
the
Triazole
Conjugates
for
Use
in
Human
Health
Risk
Assessments
Exposure
Scenario
Dose,
Uncertainty
Factors
(
UF)
FQPA
Safety
Factor
(
SF)
and
Level
of
Concern
Study
and
Toxicological
Endpoint
for
Risk
Assessment
Dermal
(
all
durations)
NOAEL
=
90
mg/
kg/
day
UF
=
100
(
dermal
absorption
rate
=
100%)
FQPA
SF
=
10
Residential
LOC
for
MOE
is
1000.

Occupational
LOC
for
MOE
is
100.
90­
Day
Oral
Toxicity
 
rat
LOAEL
is
370/
400
mg/
kg/
day
(
M/
F)
based
on
decreased
leukocyte
counts
in
males
and
decreased
triglycerides
in
females.

Inhalation
(
all
durations)
NOAEL
=
90
mg/
kg/
day
UF
=
100
(
inhal.
absorption
rate
=
100%)
FQPA
SF
=
10
Residential
LOC
for
MOE
is
1000.

Occupational
LOC
for
MOE
is
100.
90­
Day
Oral
Toxicity
 
rat
LOAEL
is
370/
400
mg/
kg/
day
(
M/
F)
based
on
decreased
leukocyte
counts
in
males
and
decreased
triglycerides
in
females.

Cancer
(
oral,
dermal,
inhalation)
Not
Classified
for
potential
carcinogenicity.
Any
potential
cancer
effects
would
be
covered
using
the
chronic
RfD.
UF,
uncertainty
factor;
FQPA
SF,
FQPA
safety
factor;
NOAEL,
no
observed
adverse
effect
level;
LOAEL,
lowest
observed
adverse
effect
level;
RfD,
reference
dose;
PAD,
population
adjusted
dose
(
a
=
acute,
c
=
chronic);
MOE,
margin
of
exposure;
LOC,
level
of
concern;
NA,
Not
Applicable.

2.
Carcinogenicity
Propiconazole.
The
Agency
classified
propiconazole
as
a
Group
C,
possible
human
carcinogen,
based
on
increased
hepatocellular
adenomas,
combined
adenomas/
carcinomas,
and
hepatocellular
carcinomas
in
male
mice
in
a
chronic
oral
feeding
study.
However,
animals
in
the
high
dose
group
for
this
study
showed
excessive
toxicity;
furthermore,
the
high
dose
exceeded
the
Maximum
Tolerated
Dose
determined
in
the
90­
day
range
finding
study.
No
treatment­
related
tumors
were
seen
in
female
mice
in
this
mouse
chronic
feeding
study.
No
tumors
were
noted
in
a
chronic
rat
study.
Therefore,
the
Reference
Dose
(
RfD)
approach
is
considered
to
be
protective
of
any
carcinogenic
effects
and
is
recommended
for
use
in
cancer
risk
assessment
for
propiconazole.
This
approach
is
also
consistent
with
results
of
voluntary
nonguideline
mechanism
of
action
studies
conducted
by
the
propiconazole
technical
registrant.

Mode
of
Action
for
Triazole
Compounds.
Research
by
the
U.
S.
Triazole
Task
Force
and
by
EPA's
National
Health
and
Environmental
Effects
Research
Laboratory
(
NHEERL)
indicates
that
the
hepatic
tumors
associated
with
parent
triazole
compounds
occur
as
a
result
in
changes
in
liver
metabolism
rather
than
by
a
genetic
response
to
the
compound.
The
triazole
compounds
do
not
appear
to
be
carcinogenic
by
a
genotoxic
mode
of
action,
but
rather
by
a
threshold
mechanism.
Therefore,
a
Reference
Dose
(
RfD)
approach
is
considered
appropriate
for
evaluating
the
hepatic
cancer
risk
associated
with
these
compounds.

Free
Triazoles.
No
chronic
toxicity
or
cancer
studies
are
available
for
1,2,4­
triazole,
triazole
alanine,
or
tirazole
acetic
acid.
However,
1,2,4­
triazole
and
triazole
alanine
are
not
mutagenic.
Because
a
chronic
cancer
study
is
not
available,
the
Agency
used
an
RfD
approach
to
assess
cancer
risks,
using
the
most
sensitive
toxicity
endpoint
and
an
additional
10X
uncertainty
factor
to
account
17
for
the
absence
of
chronic
toxicity
studies.
The
Agency
believes
that
this
approach
and
the
current
chronic
dietary
exposure
assessment
are
sufficiently
protective
of
any
cancer­
related
effects
and
is
consistent
with
the
approach
for
propiconazole.

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).
When
additional
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
propiconazole
and
the
free
triazole
metabolites
may
be
subjected
to
further
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

Propiconazole.
The
toxicology
database
for
propiconazole
did
not
show
any
estrogen,
androgen,
or
thyroid
mediated
toxicity.

Free
Triazoles.
The
toxicology
database
for
1,2,4­
triazole
showed
potential
estrogen,
androgen,
and/
or
thyroid
mediated
toxicity,
including
testicular
changes
and
sperm
abnormalities,
ovarian
changes,
delays
in
sexual
maturation,
and
dose­
related
decreases
in
thyroid
stimulating
hormone.
The
Agency's
risk
assessment
for
1,2,4­
triazole
is
protective
of
these
effects.
However,
none
of
the
available
toxicity
studies
for
triazole
alanine
and
triazole
acetic
acid
showed
any
estrogen,
androgen,
or
thyroid
toxicity.

4.
Factors
Considered
in
EPA's
Aggregate
Assessment
The
FQPA
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
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
nonoccupational
sources
of
exposure.
When
aggregating
exposure
and
risk
from
various
sources,
the
Agency
considers
the
route
and
duration
of
exposure.
Because
propiconazole
and
the
other
triazole
fungicides,
and
other
compounds
may
metabolize
to
the
free
triazoles
in
animals
and
plants,
EPA
has
considered
exposure
both
to
propiconazole
and
to
all
sources
of
the
free
triazoles
in
the
aggregate
risk
assessment.
The
components
and
basic
assumptions
of
EPA's
exposure
and
risk
assessments
for
food,
drinking
water,
and
residential
exposure
to
propiconazole
and
the
free
triazoles
are
explained
below.
18
a.
Dietary
Exposure
and
Risk
Dietary
risk
assessments
consider
exposure
to
pesticide
residues
from
both
food
and
drinking
water.
To
estimate
dietary
risks
from
food
and
drinking
water,
EPA
compares
the
estimated
amount
of
potential
exposure
to
pesticide
residues
in
food
and
drinking
water
to
the
acute
or
chronic
population
adjusted
dose,
or
PAD.
The
PAD
is
the
dose
at
which
an
individual
could
be
exposed
without
adverse
health
effects.
The
PAD
is
derived
from
the
reference
dose
(
RfD),
which
is
adjusted
for
the
FQPA
SF.
Both
acute
and
chronic
dietary
risk
assessments
were
conducted
for
propiconazole.
For
risks
resulting
from
exposure
in
food
and
drinking
water,
a
risk
estimate
that
is
less
than
100%
of
the
acute
or
chronic
PAD
(
aPAD
or
cPAD)
does
not
exceed
EPA's
level
of
concern.
For
propiconazole,
the
aPAD
is
0.3
mg/
kg/
day
for
all
population
subgroups,
and
the
cPAD
is
0.1
mg/
kg/
day.

Although
propiconazole
is
classified
as
a
group
C,
possible
human
carcinogen,
the
Agency
believes
that
the
chronic
dietary
risk
assessment
will
be
protective
of
any
potential
cancer
effects.
Therefore
an
RfD
approach
was
utilized
for
cancer
risk
assessment.
Acute
and
chronic
dietary
risk
assessments
were
conducted
for
the
general
US
population
and
several
population
subgroups,
including
females
age
13­
49
and
infants
<
1
year
old.
Additional
details
about
the
dietary
risk
assessment
for
propiconazole
are
described
in
the
August
18,
2005,
document,
Propiconazole
Acute
and
Chronic
Dietary
Exposure
Assessment
for
Reregistration
Eligibility
Decision
(
RED)
and
in
the
June
15,
2006
document,
Propiconazole
Revised
Acute
and
Chronic
Dietary
Exposure
Assessments
for
Reregistration
Evaluation
Decision
(
RED)­
Phase
4.

Food.
For
propiconazole,
EPA
assumes
that
residues
are
present,
at
the
tolerance
level,
in
all
commodities
with
existing
and
proposed
tolerances.
To
evaluate
dietary
exposure
to
the
free
triazoles
in
food,
EPA
considered
all
commodities
with
existing
tolerances
for
parent
triazole
fungicides
as
of
September
1,
2005.
EPA
assumed
that
100%
of
the
food
or
feed
crops
with
tolerances
for
propiconazole
or
other
triazole
fungicides
are
treated.
For
a
comprehensive
list
of
the
parent
triazole
fungicides
and
their
existing
tolerances,
please
see
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.

Residue
monitoring
data
for
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid
are
available
for
several
commodities;
these
monitoring
data
were
used
to
estimate
anticipated
residues
for
1,2,4­
triazole
in
food.
For
all
other
commodities,
EPA
estimated
indirect
residues
of
the
free
triazoles
by
multiplying
the
tolerance
of
the
parent
triazole
compound
by
a
metabolic
conversion
factor
and
a
molecular
weight
conversion
factor.

Dietary
exposure
was
estimated
using
food
consumption
data
from
USDA's
Continuing
Surveys
of
food
Intake
by
Individuals
(
CSFII)
from
1994
to
1996
and
1998
and
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID
 
)
.
For
processed
commodities
without
individual
tolerances,
EPA
used
default
processing
factors
from
DEEM.

Drinking
Water.
EPA
has
evaluated
potential
drinking
water
exposure
to
propiconazole
because
environmental
fate
data
for
propiconazole
indicate
it
is
persistent
and
moderately
mobile
in
soil,
with
mobility
depending
on
soil
organic
content.
This
evaluation
includes
a
review
of
the
19
existing
water
monitoring
and
environmental
fate
data
for
propiconazole.
To
date,
EPA
has
not
established
health
advisory
or
maximum
contaminant
levels
(
MCLs)
for
residues
of
propiconazole
in
drinking
water.

Because
water
monitoring
data
for
propiconazole
are
limited,
the
Agency
used
screening­
level
models
to
estimate
drinking
water
concentrations
of
propiconazole
from
surface
and
groundwater.
To
estimate
propiconazole
concentrations
in
surface
water,
EPA
used
the
PRZM­
EXAMS
screening
models,
with
an
adjustment
for
the
percent
crop
area
treated
in
an
index
reservoir,
for
all
crops
except
rice.
The
Agency
modeled
representative
scenarios
to
estimate
levels
of
propiconazole
in
surface
water
from
runoff
after
application
to
agricultural
crops,
fruit
and
nut
trees,
and
turf.
To
estimate
drinking
water
concentrations
of
propiconazole
following
application
to
rice,
the
Agency
used
a
modification
of
the
conservative
rice
paddy
model,
which
estimates
concentrations
of
a
chemical
in
the
water
column
and
in
the
undiluted
water
released
from
the
rice
paddy,
accounting
for
some
pesticide
degradation,
but
does
not
consider
movement
of
pesticide
on
suspended
sediment.
EPA's
rice
paddy
scenario
is
based
on
high
clay
soils
in
the
Mississippi
Valley
or
Gulf
Coast
regions.
To
estimate
propiconazole
concentrations
in
groundwater
sources
of
drinking
water,
EPA
used
the
Tier
I
SCI­
GROW
model,
which
is
based
on
the
results
of
several
prospective
groundwater
monitoring
studies.
Estimated
Drinking
Water
Concentrations
of
Propiconazole
(
EDWCs)
are
presented
in
Table
6.
Additional
details
regarding
the
drinking
water
exposure
assessment
for
propiconazole
may
be
found
in
the
June
29,
2005,
document,
Drinking
Water
Assessment
of
Propiconazole
and
the
June
7,
2006
document,
Revised
Drinking
Water
Assessment
of
Propiconazole.

Table
6.
Estimated
Drinking
Water
Concentrations
of
Propiconazole
Estimated
Drinking
Water
Concentration
(
EDWC),
ppm
Crop
Scenario
Region
Modeled
PCA
Acute
Chronic
Screening­
Level
Model
Used
in
Assessment
Surface
Water
York
County
PA
76.46
37.53
Turf
Osceola
County,
FL
0.87
65.28
26.54
PRZM­
EXAMS
Rice
Mississippi
Valley
Gulf
Coast
N/
A
86.4
2.92
2002
Rice
Paddy
Model
Groundwater
Turf
&
Ornamentals
Not
applicable
N/
A
0.72
0.72
SCI­
GROW
Because
very
limited
water
monitoring
data
are
available
for
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid,
the
Agency
used
screening­
level
models
to
estimate
drinking
water
concentrations
of
the
triazole
metabolites
in
surface
and
groundwater.
As
for
propiconazole,
EPA
used
the
PRZM­
EXAMS
and
SCI­
GROW
screening­
level
models
to
derive
EDWCs
for
surface
and
groundwater,
respectively.
These
values
are
presented
in
Table
7.
The
Agency
does
not
have
sufficient
information
to
model
potential
residues
of
the
triazole
conjugates
in
drinking
water;
therefore,
EPA
has
used
the
modeled
estimates
for
1,2,4­
triazole,
multiplied
by
a
factor
to
correct
for
differences
in
molecular
weight,
in
the
dietary
assessment
for
the
conjugates.
The
use
of
modeled
residue
values
for
1,2,4­
triazole
as
a
surrogate
for
residues
of
the
triazole
conjugates
in
drinking
water
is
highly
conservative.
Additional
details
regarding
the
drinking
water
assessment
for
the
free
20
triazoles
may
be
found
in
the
February
28,
2006
document,
1,2,4­
Triazole,
Triazole
Alanine,
Triazole
Acetic
Acid:
Drinking
Water
Assessment
in
Support
of
Reregistration
and
Registraiton
Actions
for
Triazole­
derivative
Fungicide
Compounds,
which
is
in
docket
EPA­
HQ­
OPP­
2005­
0497.

Table
7.
Estimated
Drinking
Water
Concentrations
of
Free
Triazoles
Estimated
Drinking
Water
Concentration
(
EDWC),
ppm
Crop
Scenario
Region
Modeled
PCA
Acute
Chronic
Screening­
Level
Model
Used
in
Assessment
Surface
Water
Turf
Pennsylvania
golf
course
N/
A
0.041
0.011
PRZM­
EXAMS
Groundwater
Turf
Pennsylvania
golf
course
N/
A
0.001
0.001
SCI­
GROW
b.
Residential
Exposure
and
Risk
Residential
risk
assessments
consider
all
potential
nonoccupational
exposures
other
than
exposures
from
residues
in
food
or
drinking
water.
For
propiconazole,
EPA
evaluated
potential
exposure
and
risk
to
residential
handlers
who
are
mixing,
loading,
or
applying
lawn
and
garden
products
or
applying
paint
containing
propiconazole
with
a
paint
brush,
paint
roller,
or
airless
sprayer
in
and
around
the
home.
The
Agency
also
evaluated
potential
post­
application
exposure
and
risk
from
adults
re­
entering
treated
areas,
such
as
lawns
or
home
gardens
to
do
yard
work
and
from
children
who
may
be
either
touching
treated
wood
in
decks
or
playsets,
mouthing
their
hands
or
various
objects
that
have
contacted
treated
turf
or
wood,
or
eating
soil
containing
pesticide
residues.
Most
residential
exposures,
including
toddler
dermal
and
incidental
oral
exposure,
are
considered
to
be
short­
term
in
duration
because
of
the
infrequent,
episodic
use
associated
with
homeowner
products.
However,
for
propiconazole,
post­
application
exposure
to
treated
decks
and
playsets
is
considered
to
be
both
shortand
intermediate­
term
in
duration
because
wood
preservatives
must
remain
on
treated
wood
for
efficacy.
In
addition,
for
1,2,4­
triazole,
post­
application
exposure
to
toddlers
ingesting
soil
containing
pesticide
residues
is
considered
to
be
intermediate­
term
exposure
because
of
this
degradate's
long
half­
life
in
soil
(~
500
days).

To
estimate
risk
from
residential
use
of
a
pesticide,
the
Agency
calculates
a
margin
of
exposure
(
MOE),
which
is
the
ratio
of
the
NOAEL
selected
for
risk
assessment
to
the
exposure.
This
MOE
is
compared
to
a
level
of
concern,
which
is
the
same
value
as
the
uncertainty
factor
(
UF)
applied
to
a
particular
toxicity
study.
The
standard
UF
is
100X
(
10X
for
interspecies
extrapolation
and
10X
intraspecies
variation),
plus
any
additional
safety
factors,
such
as
an
FQPA
SF.
An
MOE
less
than
the
target
MOE,
or
level
of
concern,
is
generally
a
risk
concern
to
the
Agency.
As
previously
mentioned
in
this
document,
the
FQPA
SF
for
propiconazole
has
been
reduced
to
1X;
therefore,
the
Agency's
level
of
concern
is
an
MOE
of
100
for
propiconazole.
The
FQPA
SF
for
the
free
triazoles,
however,
is
10X;
therefore,
the
Agency's
level
of
concern
is
an
MOE
of
1000
for
the
free
triazoles.
Further,
for
the
free
triazoles,
some
exposure
scenarios
bear
an
additional
3X
uncertainty
factor
for
the
lack
of
a
NOAEL;
in
these
cases,
the
Agency's
level
of
concern
is
an
MOE
of
3000.
21
Although
propiconazole
is
registered
as
a
wood
preservative
for
dimensional
lumber,
it
is
not
currently
marketed
for
use.
To
complete
reregistration,
EPA
must
evaluate
potential
exposure
and
risk
from
all
registered
uses,
including
short­
and
intermediate­
term
post­
application
exposure
to
children
playing
on
decks
and
play
sets
built
from
dimensional
lumber
treated
with
propiconazole.
However,
the
Agency
does
not
have
adequate
wood
surface
residue
(
i.
e.,
wood
wipe)
data
necessary
to
conduct
a
chemical­
specific
post­
application
exposure
assessment.
Therefore,
EPA
conducted
a
high­
end
deterministic
screening­
level
assessment
to
estimate
potential
post­
application
exposure
to
children.
The
Agency
is
also
requiring
a
confirmatory
wood
surface
wipe
study
as
part
of
this
RED.

No
other
residential
post­
application
exposure
scenarios
were
evaluated
because
use
of
propiconazole
in
paint
or
caulk
is
not
expected
to
result
in
exposure
after
the
caulk
and
paint
have
dried.
Although
additional
homeowner
exposure
could
occur
from
use
of
propiconazole
as
a
material
preservative
in
a
variety
of
consumer
products,
the
technical
registrants
Syngenta
and
Janssen,
have
requested
that
propiconazole
use
on
carpet
fibers,
apparel,
and
furnishings
be
deleted
from
product
labels.
The
Agency
published
a
Federal
Register
Notice
on
March
8,
2006,
announcing
receipt
of
this
request.
Because
no
comments
were
received
in
response
to
this
Notice,
EPA
issued
cancellation
orders
for
these
uses
on
May
26,
2006.
Therefore,
these
uses
have
not
been
included
in
the
risk
assessment
for
this
RED.

The
Agency
has
evaluated
residential
exposure
and
risk
associated
with
the
free
triazoles
because
other
triazole
fungicides,
in
addition
to
propiconazole,
are
used
on
residential
lawns.
EPA
has
based
the
exposure
assessment
for
the
free
triazoles
on
the
use
of
triademifon
on
residential
turf
because
triademifon
is
the
greatest
source
of
residential
exposure
of
any
of
the
triazole
fungicides.
The
Agency
has
evaluated
dermal
and
inhalation
exposure
to
residential
handlers,
dermal
postapplication
exposure
to
adults
doing
yardwork
and
to
children
who
may
be
mouthing
their
hands
or
various
objects
that
have
contacted
treated
or
who
may
be
eating
soil
containing
pesticide
residues.
As
a
result
of
its
review,
the
Agency
has
determined
that
there
is
potential
residential
exposure
to
1,2,4­
triazole,
but
no
potential
exposure
to
the
triazole
conjugates
(
TA
and
TAA),
because
these
compounds
are
formed
within
the
plant
and
residues
are
not
available
on
the
leaf
surface.
As
previously
mentioned,
residential
exposure
to
toddlers
from
soil
ingestion
is
considered
to
be
intermediate­
term
in
duration
because
1,2,4­
triazole
has
a
long
half­
life
in
soil.

Additional
details
regarding
the
residential
exposure
and
risk
assessments
for
propiconazole
may
be
found
in
the
following
documents:
Propiconazole
Occupational
and
Residential
Exposure
Assessment,
dated
January
31,
2006;
Propiconazole
Occupational
and
Residential
Exposure
Assessment
of
Antimicrobial
Uses,
dated
February
1,
2006;
Amendment
to
the
Propiconazole
Reregistration
Eligibility
Decision
(
RED)
Document
for
Children's
Postapplication
Exposure
to
Treated
Structures,
dated
June
20,
2006;
and
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,
dated
February
7,
2006.

5.
Aggregate
Risk
Assessment
for
Propiconazole
and
Free
Triazoles
Propiconazole,
the
other
triazole
fungicides,
and
other
compounds
may
be
metabolized
to
the
free
triazoles
in
animals
and
plants.
Therefore,
EPA
has
conducted
aggregate
risk
assessments
for
potential
food,
drinking
water,
and
residential
exposure
resulting
from
exposure
to
propiconazole
22
parent
and
from
exposure
to
all
sources
of
the
free
triazoles.
Table
8
lists
the
aggregate
risk
assessments
that
the
Agency
has
conducted
for
propiconazole
and
for
the
free
triazoles
(
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid).
As
previously
mentioned,
EPA
only
evaluated
two
intermediate­
term
exposure
scenarios
for
residential
use:
toddlers
ingesting
soil
containing
residues
of
1,2,4­
triazole
and
toddlers
playing
on
decks
or
play
sets
made
from
wood
treated
with
propiconazole.

Table
8.
Summary
of
Aggregate
Risk
Assessments
Conducted
for
Propionazole
and
its
Degradates
Residues
Considered
Exposure
Duration
Propiconazole
1,2,4­
Triazole
Triazole
Alanine
&
Triazole
Acetic
Acid
Acute
food
+
drinking
water
food
+
drinking
water
food
+
drinking
water
Short­
Term
food
+
drinking
water
+
residential*,*
food
+
drinking
water
+
residential*

Intermediate­
Term
food
+
drinking
water
+
residential*
food
+
drinking
water
+
residential**
Not
assessed,
1,2,4­
triazole
assessment
is
protective*

Chronic
food
+
drinking
water
food
+
drinking
water
food
+
drinking
water
*
Residential
exposure
to
children
playing
on
decks
and
play
sets
constructed
of
propiconazole
treated
wood.
*
Residential
exposure
to
adults
from
yard
work
and
to
children
from
dermal
exposure
or
from
hand­
to­
mouth
or
object­
to
mouth
incidental
oral
exposure.
**
Residential
exposure
to
toddlers
via
soil
ingestion.
*
Residues
of
the
conjugates
are
not
found
on
the
leaf
surface
and
are
therefore
not
available
for
dermal
exposure
or
hand­
to­
mouth
or
object­
to­
mouth
incidental
oral
exposure.
Because
1,2,4­
triazole
is
more
toxic
than
the
conjugates
the
risk
assessment
for
1,2,4­
triazole
is
protective
of
the
conjugates.

a.
Aggregate
Risk
from
Propiconazole
Acute
Aggregate
Risk.
The
acute
aggregate
risk
assessment
for
propiconazole
considers
exposure
from
food
and
drinking
water
only
because
there
are
no
other
pathways
of
acute
exposure.
The
Agency
incorporated
the
peak
estimated
drinking
water
concentations
(
EDWCs)
for
propiconazole
into
the
dietary
exposure,
using
the
DEEM
software.
Total
dietary
exposure
from
food
and
water
was
then
compared
to
the
aPAD
for
propiconazole.
At
the
95th
percentile,
dietary
exposure
to
the
US
population
comprised
3%
of
the
aPAD;
exposure
to
infants
<
1
year
old
(
the
most
highly
exposed
subgroup)
comprised
8%
of
the
aPAD,
and
exposure
to
females
age
13­
49
comprised
2%
of
the
aPAD.
Because
total
dietary
exposure
from
propiconazole
is
less
than
100%
aPAD,
acute
aggregate
exposure
from
propiconazole
is
below
the
Agency's
level
of
concern.

Short­
Term
Aggregate
Risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
average
exposure
levels
to
food
and
drinking
water
(
considered
to
be
a
background
exposure
level).
The
highest
residential
handler
exposure
scenarios
for
agricultural
(
hose­
end
sprayer)
and
antimicrobial
use
(
paint
brush/
roller)
are
used
for
the
aggregate
exposure
assessment.
Based
on
the
residential
use
pattern,
post­
application
exposure
to
propiconazole
for
adults
are
from
dermal
exposure
only.
Infants
and
children
are
expected
to
be
exposed
by
both
the
dermal
and
oral
routes
(
incidental
exposure).
This
aggregate
exposure
assessment
is
considered
highly
conservative.
As
shown
in
Table
9,
MOEs
for
aggregate
short­
term
risk
from
food,
drinking
water,
and
residential
use
range
from
120
to
500,
and
are
all
below
the
Agency's
level
of
concern.
23
The
Agency
considered
short­
term
risk
for
residential
handlers
using
propiconazole
in
home
gardens
and
for
residential
handlers
using
paint
containing
propiconazole,
as
well
as
risk
for
adults
and
children
receiving
post­
application
exposure.
Short­
term
MOEs
for
residential
handlers
and
postapplication
exposure
to
adults
and
children
(
toddlers)
are
all
greater
than
100
and
below
EPA's
level
of
concern
and
are
therefore
not
presented
in
Table
9.
Combined
short­
term
inhalation
and
dermal
MOEs
for
residential
handlers
range
from
120
to
40,000.
Short­
term
post­
application
dermal
MOEs
range
from
210
to
410
for
toddlers
and
350
to
50,000
for
adults;
post­
application
incidental
oral
MOEs
range
from
1,100
to
330,000
(
children
only).
The
combined
short­
term
dermal
and
incidental
oral
MOE
is
170
for
children
playing
on
treated
lawns
and
410
for
children
playing
on
decks
or
play
sets
built
with
lumber
treated
with
propiconazole
Intermediate­
Term
Aggregate
Risk.
EPA
considered
intermediate­
term
aggregate
risk
for
propiconazole
for
toddlers
playing
on
decks
or
play
sets
built
with
lumber
treated
with
propiconazole
who
are
also
receiving
background
exposure
to
residues
in
food
and
drinking
water.
The
intermediate­
term
aggregate
risk,
which
includes
post­
application
exposure
children
and
background
exposure
from
food
and
drinking
water,
is
an
MOE
of
130,
as
shown
in
Table
9
below.

Table
9.
Short­
and
Intermediate­
Term
Aggregate
Risk
Estimates
for
Residential
Exposure
to
Propiconazole
Exposure
Scenario
Level
of
Concern
MOE
Food
+
Drinking
Water
Combined
Dermal
and
Inhalation
MOE
Oral
MOE
(
Incidental
Ingestion)
Aggregate
MOE
Residential
Handler
(
Use
on
Turf
and
in
Paint)

Hose­
end
sprayer
100
9700
530
N/
A
500
Paint
Airless
Sprayer
100
9700
120
N/
A
120
Residential
Post­
Application
(
Residential
Turf)

Adult
­
General
high
contact
activities
100
9700
350
N/
A
340
Toddler
 
General
high
contact
activities*
100
3800
450
4,500
160
Residential
Post­
Application
(
Treated
Decks
and
Play
sets)

Toddler
­
General
high
contact
activities**
100
3800
450
(
short­
term)

150
(
int.­
term)
5,300
(
short­
term)

1,800
(
int.­
term)
288
130
*
Toddler
general
high­
contact
activities
include
dermal
exposure
from
playing
on
treated
turf
as
well
as
incidental
oral
exposure
from
toddlers
mouthing
their
hands,
objects
that
have
come
in
contact
with
turf,
or
ingesting
soil
containing
residues.
**
Post
application
exposure
to
toddlers
playing
on
decks
&
play
sets
is
considered
to
be
both
short­
and
intermediate­
term
in
duration.

Chronic
Aggregate
Risk.
Because
the
existing
residential
uses
of
propiconazole
are
not
likely
to
result
in
chronic
exposure
to
propiconazole,
chronic
aggregate
includes
food
and
drinking
water
only.
The
dietary
exposure
from
drinking
water
(
derived
from
screening­
level
models)
has
been
included
in
the
DEEM
analysis.
Because
the
RfD
approach
used
to
evaluate
chronic
dietary
risk
is
considered
protective
of
any
cancer
risk
concern,
only
the
results
of
the
chronic
analysis
is
given.
Chronic
dietary
exposure
to
the
US
population
comprised
3%
of
the
cPAD,
and
exposure
to
infants
<
1
year
old
(
the
most
highly
exposed
subgroup)
comprised
8%
of
the
cPAD,
which
is
below
the
24
Agency's
level
of
concern.

b.
Aggregate
Risk
from
Free
Triazoles
Acute
Aggregate
Risk.
The
acute
aggregate
risk
assessments
for
1,2,4­
triazole
and
for
the
triazole
conjugates
triazole
alanine
and
triazole
acetic
acid
only
consider
exposure
from
food
and
drinking
water
because
there
are
no
other
pathways
of
acute
exposure.
The
Agency
incorporated
the
peak
EDWCs
for
1,2,4­
triazole
and
for
the
triazole
conjugates
into
the
dietary
exposure,
using
the
DEEM
software.
Total
dietary
exposure
from
food
and
drinking
water
was
then
compared
to
the
appropriate
aPAD.
At
the
95th
percentile
of
exposure,
acute
dietary
exposure
for
children
age
1­
2
years
(
the
most
highly
exposed
population)
comprised
32%
of
the
aPAD
for
1,2,4­
triazole.
For
the
triazole
conjugates,
the
toxicological
endpoint
is
only
relevant
to
females
of
childbearing
age.
The
DEEM
results
for
the
triazole
conjugates
showed
that
females
age
13­
49
years
had
dietary
exposure
at
the
95th
percentile
comprising
27%
of
the
aPAD.
Therefore,
acute
aggregate
risk
for
the
free
triazoles
is
below
EPA's
level
of
concern.

Short­
Term
Aggregate
Risk.
For
1,2,4­
triazole,
the
short­
term
aggregate
risk
assessment
considers
worst­
case
residential
exposure
from
triademifon,
the
triazole
fungicide
with
the
highest
application
rate
on
residential
lawns,
combined
with
background
exposure
from
food
and
drinking
water.
The
residential
risk
assessment
for
the
triazoles
includes
the
following
exposure
scenarios:
adult
handlers
applying
pesticide
with
a
hose
end
sprayer
or
low­
pressure
hand
wand,
post­
application
exposure
to
adults
and
toddlers
from
dermal
contact
or
incidental
oral
exposure
from
soil
ingestion
or
from
mouthing
hands
or
objects
that
have
contacted
treated
turf.
Short­
term
dermal
MOEs
for
residential
handlers
exposed
to
1,2,4­
triazole
(
from
use
of
triademifon)
range
from
3,500
for
children
to
3,900
for
adults.
Short­
term
incidental
oral
MOEs
for
children
are
7,300
for
hand­
to­
mouth
exposure
and
30,000
for
object­
to­
mouth
exposure.
Because
all
of
these
MOE
values
are
above
1000,
residential
risks
for
1,2,4­
triazole
are
below
the
Agency's
level
of
concern.

Short­
term
aggregate
MOEs
for
1,2,4­
triazole
range
from
1,900
to
4,000
for
all
population
subgroups.
These
MOEs,
which
consider
potential
residential
exposure
with
background
exposure
from
food
and
drinking
water,
are
all
greater
than
the
target
MOE
of
1,000,
and
below
the
Agency's
level
of
concern.
The
Agency
believes
that
there
is
no
potential
residential
exposure
to
the
triazole
conjugates
(
TA
and
TAA)
because
these
compounds
are
formed
within
the
plant
and
residues
are
not
available
on
the
leaf
surface.
Although
residues
of
the
triazole
conjugates
may
also
be
available
in
soil,
the
risk
assessment
for
soil
ingestion
of
1,2,4­
triazole
is
believed
to
be
protective
because
1,2,4­
triazole
is
more
toxic
than
the
triazole
conjugates.
Therefore,
short­
term
aggregate
risks
for
the
free
triazoles
are
below
EPA's
level
of
concern.

Intermediate­
Term
Aggregate
Risk.
For
1,2,4­
triazole,
the
intermediate­
term
aggregate
risk
assessment
considers
potential
exposure
to
children
via
soil
ingestion
combined
with
background
exposure
from
food
and
drinking
water.
The
intermediate­
term
MOE
for
children
receiving
incidental
oral
exposure
via
soil
ingestion
is
1,600,000,
which
is
below
the
Agency's
level
of
concern.
Intermediate­
term
aggregate
MOEs
range
from
7,600
to
28,000
for
all
population
subgroups,
and
are
all
greater
than
3000,
the
Agency's
level
of
concern
for
intermediate­
term
MOEs.
Because
the
risk
assessment
for
soil
ingestion
of
1,2,4­
triazole
is
believed
to
be
protective
of
the
triazole
conjugates,
the
intermediate­
term
aggregate
risks
for
the
free
triazoles
are
all
below
the
Agency's
level
of
concern.
25
Chronic
Aggregate
Risk.
As
with
the
acute
aggregate
risk
assessments,
the
chronic
aggregate
risk
assessments
for
1,2,4­
triazole
and
for
the
triazole
conjugates
only
consider
exposure
from
food
and
drinking
water
because
there
are
no
other
pathways
of
chronic
exposure.
Chronic
dietary
exposure
from
food
and
drinking
water
for
the
most
highly
exposed
subpopulation,
children
age
1­
2
years
comprised
39%
of
the
cPAD
for
1,2,4­
triazole
and
27%
of
the
cPAD
for
the
triazole
conjugates.
Therefore,
chronic
aggregate
risks
for
the
free
triazoles
are
below
EPA's
level
of
concern.

c.
Pesticide
and
Pharmaceutical
Assessment
for
Free
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
Food
and
Drug
Administration
(
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,
propiconazole
shares
a
common
metabolite,
1,2,4­
triazole,
with
several
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
pharmaceutical
uses
as
described
above.
Therefore,
EPA
concludes
that
the
potential
dietary
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
26
summarizing
EPA
and
FDA
discussions
on
potential
free
triazole
metabolites
of
traizole
derivative
drugs,
(
both
available
in
the
public
docket
for
propiconazole,
EPA­
HQ­
OPP­
2005­
0497)
for
additional
information.

6.
Occupational
Exposure
and
Risk
Workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
the
pesticide;
these
workers
are
called
pesticide
"
handlers."
Workers
can
also
be
exposed
to
residues
of
a
pesticide
when
re­
entering
treated
areas.
For
dermal
and
inhalation
exposures,
worker
risk
is
estimated
by
a
Margin
of
Exposure
(
MOE)
which
determines
how
close
the
occupational
exposure
comes
to
the
No
Observed
Adverse
Effect
Level
(
NOAEL)
selected
from
animal
studies.
Based
on
the
use
pattern
for
propiconazole
and
the
toxicological
database
for
propiconazole,
the
Agency
has
determined
that
short­
and
intermediate­
term
(
but
not
lifetime)
exposures
should
be
included
in
the
risk
assessment.
The
toxicological
endpoints
used
in
the
occupational
risk
assessment
are
presented
in
Table
3
of
this
document,
and
EPA
assumed
40%
dermal
absorption
based
on
an
animal
study.

The
Agency
typically
evaluates
exposure
to
pesticide
handlers
using
different
levels
of
personal
protective
equipment
(
PPE).
EPA
typically
conducts
an
initial
exposure
assessment
assuming
baseline
clothing,
and
then
adds
PPE
in
a
tiered
approach
to
determine
the
level
of
additional
PPE
necessary
to
obtain
appropriate
MOEs.
This
approach
is
allows
the
Agency
to
determine
the
appropriate
PPE
and
other
label
language
using
a
risk­
based
approach.

In
the
handler
exposure
assessments
for
propiconazole,
EPA
evaluated
the
following
clothing
scenarios:
 
baseline,
which
consists
of
long­
sleeve
shirt,
and
long
pants
but
no
gloves
or
respirator,
 
baseline
plus
chemical­
resistant
gloves,
and
 
engineering
controls
(
for
antimicrobial
uses
only).

All
current
propiconazole
labels
for
agricultural
use
require
baseline
PPE
plus
chemical­
resistant
gloves;
labels
registered
for
antimicrobial
use
products
also
require
baseline
PPE,
chemical­
resistant
gloves,
and
protective
eyewear.

Because
propiconazole
is
used
both
in
agricultural
and
antimicrobial
sites,
the
Agency
conducted
separate
assessments
for
these
sites.
Additional
details
regarding
the
occupational
exposure
and
risk
assessments
for
propiconazole
may
be
found
in
the
following
documents:
Propiconazole
Occupational
and
Residential
Exposure
Assessment,
dated
January
31,
2006
and
Propiconazole
Occupational
and
Residential
Exposure
Assessment
of
Antimicrobial
Uses,
dated
February
1,
2006.

a.
Handler
Exposure
and
Risk
Agricultural
Uses
of
Propiconazole.
The
exposure
and
risk
assessment
for
occupational
handlers
addressed
the
following
scenarios:
mixer/
loader,
applicator,
and
flagger.
These
scenarios
were
used
to
estimate
exposures
based
on
application
of
the
formulations
of
propiconazole
currently
registered
for
use
in
agriculture
(
i.
e.,
wettable
powder
(
water
soluble
packs)
and
liquid).
As
previously
mentioned,
EPA
evaluated
both
short­
and
intermediate­
term
occupational
exposures
and
risks.
27
For
agricultural
scenarios,
no
chemical­
specific
handler
data
were
available
for
propiconazole,
so
EPA
used
unit
exposure
values
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
to
estimate
handler
exposures.
The
Agency
used
standard
default
assumptions
for
the
number
of
acres
treated
per
day,
worker
body
weight,
hours
worked,
etc.,
for
most
handler
scenarios.

For
liquid
formulations,
handler
risks
for
most
scenarios
were
above
EPA's
level
of
concern
(
i.
e.,
MOEs
<
100)
for
mixer/
loaders,
both
short­
and
intermediate­
term
exposure,
with
baseline
clothing
(
long
sleeve
shirt,
long
pants,
shoes
and
socks,
but
no
gloves).
However,
these
same
handler
risks
were
below
the
Agency's
level
of
concern
(
MOEs
>
100)
with
the
addition
of
chemical­
resistant
gloves.

For
wettable
powders
formulated
in
water­
soluble
packs
(
an
engineering
control),
handler
risks
were
below
the
Agency's
level
of
concern
(
i.
e.,
MOEs
>
100)
for
all
scenarios
with
baseline
clothing.
Also,
handler
risks
for
mixer/
loader/
applicators
using
liquid
formulations
and
high­
or
lowpressure
handwand,
handgun
sprayer,
or
seed
piece
dip
were
below
the
Agency's
level
of
concern
both
at
baseline
and
with
gloves.
Applicator
and
flagger
risks
were
below
EPA's
level
of
concern
(
i.
e.,
MOEs
>
100)
for
all
formulations
with
baseline
clothing.
Handler
risk
estimates
for
the
agricultural
uses
of
propiconazole
are
presented
in
Table
10.
29
Table
10.
Short­
and
Intermediate­
Term
Handler
Risk
Estimates
for
Agricultural
Uses
of
Propiconazole
Margin
of
Exposure
(
MOE)

Short­
Term
Exposure
Intermediate­
Term
Exposure
Exposure
Scenario
Crops
Appl.
Rate
(
lb
ai/
acre
or
lb
ai/
gallon)
Area
Treated
(
acre/
day)
Baseline*
Baseline
+
Gloves
Baseline*
Baseline
+
Gloves
Mixer/
Loader
 
Liquid
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
0.1125
1200
13
1500
4.5
500
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
350
46
5100
15
1700
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
0.225
350
23
2600
7.7
850
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
Rice
0.225
350
23
2600
7.7
850
Sod­
farm
turf
1.8
350
2.9
320
1.0
110
Wheat
0.08
1200
19
2100
6.3
700
Aerial
Rice
0.28
1200
5.4
600
1.8
200
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
0.1125
200
80
9000
27
3000
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
80
200
22000
67
7500
Non­
bearing
Citrus,
Non­
bearing
Hazelnuts,
Pecans,
Peanuts
0.225
80
100
11000
33
3700
Grasses
grown
for
seed
(
forage
and
fodder
grasses)
0.225
80
100
11000
33
3700
Sod
farm
turf
80
13
1400
4.2
470
Golf
Course
turf
1.8
40
25
2800
8.4
930
Groundboom
Wheat
0.08
200
110
13000
38
4200
Pecans,
Non­
bearing
Citrus
0.225
40
200
22000
67
7500
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum)
0.1125
40
400
45000
130
15000
Ornamental
(
Flowering
and
Woody
plants)
0.37
40
120
14000
41
4500
Airblast
Bananas
and
Plantains
0.084
40
540
60000
180
20000
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower,
Celery
0.1125
350
46
5100
15
1700
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Non­
bearing
citrus,

Peanut
0.225
350
23
2600
7.7
850
Wheat
0.08
350
65
7200
22
2400
Chemigation
Rice
0.28
350
18
2100
6.2
690
Handgun
Sprayer
Turf
1.8
100
10
1100
3.3
370
30
Table
10.
Short­
and
Intermediate­
Term
Handler
Risk
Estimates
for
Agricultural
Uses
of
Propiconazole
Margin
of
Exposure
(
MOE)

Short­
Term
Exposure
Intermediate­
Term
Exposure
Exposure
Scenario
Crops
Appl.
Rate
(
lb
ai/
acre
or
lb
ai/
gallon)
Area
Treated
(
acre/
day)
Baseline*
Baseline
+
Gloves
Baseline*
Baseline
+
Gloves
Mixer/
Loader
­
Wettable
Powder
in
Water
Soluble
Packets
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
0.1125
1200
1800
N/
A**
600
N/
A
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
350
6200
N/
A
2100
N/
A
Aerial
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
0.225
350
3100
N/
A
100
N/
A
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
rice
0.225
350
3100
N/
A
100
N/
A
Sod­
farm
turf
1.8
350
390
N/
A
130
N/
A
Wheat
0.08
1200
2500
N/
A
840
N/
A
Aerial
Rice
0.28
1200
720
N/
A
240
N/
A
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
0.1125
200
11000
N/
A
3600
N/
A
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
80
27000
N/
A
9000
N/
A
Non­
bearing
Citrus,
Non­
bearing
Hazelnuts,
Pecans,
Peanuts
0.225
80
14000
N/
A
4500
N/
A
Grasses
grown
for
seed
(
forage
and
fodder
grasses)
0.225
80
14000
N/
A
4500
N/
A
Sod
Farm
turf
80
1700
N/
A
560
N/
A
Golf
Course
turf
1.8
40
3400
N/
A
110
N/
A
Groundboom
Wheat
0.08
200
15000
N/
A
5100
N/
A
Pecans,
Non­
bearing
Citrus
0.225
40
27000
N/
A
9000
N/
A
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum)
0.1125
40
54000
N/
A
18000
N/
A
Ornamental
(
Flowering
and
Woody
plants)
0.37
40
16000
N/
A
5500
N/
A
Airblast
Bananas
and
Plantains
0.084
40
72000
N/
A
24000
N/
A
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower,
Celery
0.1125
350
6200
N/
A
2100
N/
A
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Non­
bearing
citrus,

Peanut
0.225
350
3100
N/
A
1000
N/
A
Wheat
0.08
200
8700
N/
A
2900
N/
A
Chemigation
Rice
0.28
350
2500
N/
A
830
N/
A
Handgun
Sprayers
Turf
1.8
100
1400
N/
A
450
N/
A
31
Table
10.
Short­
and
Intermediate­
Term
Handler
Risk
Estimates
for
Agricultural
Uses
of
Propiconazole
Margin
of
Exposure
(
MOE)

Short­
Term
Exposure
Intermediate­
Term
Exposure
Exposure
Scenario
Crops
Appl.
Rate
(
lb
ai/
acre
or
lb
ai/
gallon)
Area
Treated
(
acre/
day)
Baseline*
Baseline
+
Gloves
Baseline*
Baseline
+
Gloves
Applicator
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
0.1125
1200
7500
16000
2500
5500
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
350
26000
56000
8600
19000
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
0.225
350
31000
28000
4300
9400
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
rice
0.225
350
31000
28000
4300
9400
Sod­
farm
turf
1.8
350
1600
3500
540
1200
Wheat
0.08
1200
11000
23000
3500
7700
Aerial
Rice
0.28
1200
3000
6600
1000
2200
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
0.1125
200
15000
15000
4900
4900
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
80
37000
37000
12000
12000
Non­
bearing
Citrus,
Non­
bearing
Hazelnuts,
Pecans,
Peanuts
0.225
80
18000
18000
6100
6100
Grasses
grown
for
seed
(
forage
and
fodder
grasses)
0.225
80
18000
18000
6100
6100
Sod
Farm
turf
1.8
80
2300
2300
770
770
Groundboom
(
Open
Cab)
Wheat
0.08
200
21000
21000
6900
6900
Pecans,
Non­
bearing
Citrus
0.225
40
1600
2300
520
770
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum)
0.1125
40
3100
4600
1000
1500
Ornamental
(
Flowering
and
Woody
plants)
0.37
40
960
1400
320
470
Airblast
Bananas
and
Plantains
0.084
40
4200
6200
1400
2100
32
Table
10.
Short­
and
Intermediate­
Term
Handler
Risk
Estimates
for
Agricultural
Uses
of
Propiconazole
Margin
of
Exposure
(
MOE)

Short­
Term
Exposure
Intermediate­
Term
Exposure
Exposure
Scenario
Crops
Appl.
Rate
(
lb
ai/
acre
or
lb
ai/
gallon)
Area
Treated
(
acre/
day)
Baseline*
Baseline
+
Gloves
Baseline*
Baseline
+
Gloves
Flagger
Barley,
Rye,
Oats,
Wheat,
Corn,
Sunflower
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,

Triticale
0.1125
350
11000
N/
A
3700
N/
A
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
rice
0.225
350
5600
N/
A
1900
N/
A
Sod­
farm
turf
1.8
350
700
N/
A
230
N/
A
Wheat
0.08
350
16000
N/
A
5300
N/
A
Aerial
applications
Rice
0.28
350
4500
N/
A
1500
N/
A
Mixer/
Loader/
Applicator
(
Liquid
formulations)

High
Pressure
Handwand
Non­
bearing
Fruits
and
Nuts,
Ornamental
Woody
and
Flowering
plants
1000
gal
handled/
day
*
N/
A
780
N/
A
260
Low
Pressure
Handwand
Non­
bearing
Fruits
and
Nuts,
Ornamental
Woody
and
Flowering
plants
0.0024
40
gal
handled/
day
550
110000
180
36000
Handgun
Sprayer
Turf
1.8
5
N/
A
12000
N/
A
390
Seed
Piece
Dip
Sugarcane
(
HI
only)
0.00021
1000
gal
handled/
day
8600
960000
2900
320000
MOE
=
NOAEL/
Daily
Dose
where
the
NOAEL
for
both
dermal
and
inhalation
is
30.0
mg/
kg/
day
for
Short­
term
and
10.0
mg/
kg/
day
for
Intermediate­
term
exposures.

The
target
MOE
is
100
for
both
short­
and
intermediate­
term
occupational
exposures.
*
Baseline
clothing
consists
of
long
sleeve
shirt,
long
pants,
shoes
and
socks
but
no
gloves
or
respirator.
N/
A
 
not
applicable.
**
Gloves
are
not
considered
for
scenarios
with
engineering
controls,
such
as
wettable
powders
with
water
soluble
bags
or
aerial
application
with
closed
cockpit.
*
Amount
handled
is
described
as
gal/
day
rather
than
area
treated
for
high
and
low
pressure
handwand
and
seed
piece
treatment
MOEs
in
bold
are
above
EPA's
level
of
concern.
33
Antimicrobial
Uses
of
Propiconazole.
As
previously
mentioned,
propiconazole
is
registered
for
use
as
both
a
material
preservative
(
in
adhesives,
caulk,
paints,
textiles,
and
metalworking
fluid),
and
as
a
wood
preservative.
Occupational
handler
exposure
can
occur
when
a
worker
is
adding
preservative
to
treated
materials.
The
exposure
and
risk
assessment
for
occupational
handlers
addressed
the
following
scenarios:
(
1)
Material
Preservative
 
Liquid
pour
(
transfer
of
antimicrobial
from
a
small
container
to
an
open
vat),
 
Liquid
pump
(
transfer
of
antimicrobial
to
a
closed
tote
via
a
chemical
metering
pump
or
gravity
flow),
 
Paint
application
by
brush,
roller,
or
airless
sprayer;
and
(
2)
Wood
Preservative
 
Blender
spray
operators
 
Chemical
operators
 
Diptank
operators
 
High
pressure/
high
volume
spray
o
Wood
treatment
o
Mushroom
houses
o
Cooling
towers
 
Pressure
treatment
of
wood
These
scenarios
were
used
to
estimate
exposures
based
on
application
of
the
formulations
of
propiconazole
currently
registered
for
antimicrobial
use.
The
Agency
evaluated
both
short­
and
intermediate­
term
occupational
exposures
and
risks
for
these
use
scenarios.
Table
11
provides
a
summary
of
short­
and
intermediate­
term
handler
MOEs
for
antimicrobial
uses.

Material
Preservative.
For
use
of
propiconazole
as
a
material
preservative,
combined
inhalation
and
dermal
total
short­
term
handler
MOEs
range
from
<
1
to
6,500
at
baseline
(
longsleeved
shirt,
long
pants,
shoes
and
socks)
and
from
300
to
26,000
with
the
addition
of
chemicalresistant
gloves.
Likewise,
intermediate­
term
handler
MOEs
range
from
<
1
to
2,200
at
baseline
and
100
to
8,600
with
chemical­
resistant
gloves.
Worker
risks
are
of
concern
for
workers
applying
paint
containing
propiconazole
as
an
in­
can
preservative
under
the
following
scenarios:
 
Painting
with
brush/
roller
or
airless
sprayer
 
combined
intermediate­
term
MOE
of
55,
at
baseline,
and
 
Painting
with
airless
sprayer
­
combined
short­
term
MOE
of
75
and
intermediate­
term
MOE
of
25,
at
baseline.

Wood
Preservative.
For
blender/
spray
operators,
chemical
operators,
and
diptank
operators
wearing
gloves,
short­
term
combined
MOEs
range
from
400
to
850
and
intermediate­
term
MOEs
range
from
130
to
280.
Handler
MOEs
for
high­
pressure/
high
volume
spray
treatment
range
from
150
to
1,500
for
short­
term
exposure
and
from
50
to
500
for
intermediate­
term
exposure;
again,
these
MOEs
assume
that
chemical­
resistant
gloves
are
worn.
The
MOE
of
50
is
for
application
of
propiconazole
to
mushroom
houses
in
a
high
volume
spray
of
1000
gallons
per
day.
For
workers
pressure
treating
wood,
the
combined
short­
term
MOE
ranges
from
260
to
2,200
and
the
intermediateterm
MOE
ranges
from
86
to
730
with
gloves.
34
Table
11.
Short­
and
Intermediate­
Term
Handler
Risk
Estimates
for
Antimicrobial
Uses
of
Propiconazole
MOEs
for
Short­
Term
Exposure
MOEs
for
Intermediate­
Term
Exposure
Dermal
Total
Dermal
Total
Use
Site
Application
Method
Appl.

Rate
(%

ai
by
wt)
Amount
Handled
or
Treated
per
Day
Baseline
Gloves
Inhal.
Baseline
Gloves
Baseline
Gloves
Inhal.
Baseline
Gloves
MATERIAL
PRESERVATIVE
Liquid
Pour
<
1
320
4,300
<
1
300
<
1
110
1,700
<
1
100
Adhesives
Liquid
Pump
1.21
10,000
lbs
95
6,900
37,000
95
5,900
32
2,200
14,000
32
2,000
Liquid
Pour
60
16,000
120,000
60
15,000
20
5,400
47,000
20
4,900
Metal
Working
Fluids
Liquid
Pump
0.07
2,500
lbs
6,600
9,600
300,000
6,500
9,300
2,200
3,200
110,000
2,200
3,100
Liquid
Pour
0.35
2,000
lbs
15
5,600
74,000
15
5,200
5
1,900
29,000
5
1,700
Paint
Liquid
Pump
0.35
10,000
lbs
330
24,000
130,000
330
21,000
110
7,900
50,000
110
6,900
Liquid
Pour
4
1,400
19,000
4
1,300
1
460
7,200
1
440
Textiles
Liquid
Pump
0.28
10,000
lbs
410
30,000
160,000
410
26,000
140
9,900
62,000
140
8,600
Professional
Application
of
Paint
Brush/

Roller
0.35
50
lbs
170
N/
A*
37,000
170
N/
A*
56
N/
A*
14,000
55
N/
A*

Paint
Airless
Sprayer
0.35
500
lbs
79
N/
A*
1,200
75
N/
A*
26
N/
A*
480
25
N/
A*

WOOD
PRESERVATIVE
0.5
178,000
N/
A
940
5,900
N/
A
810
N/
A
310
2,000
N/
A
270
Blender/

Spray
Operator
1.0
178,000
N/
A
470
2,900
N/
A
400
N/
A
160
980
N/
A
130
Chemical
Operator
N/
A
N/
A
860
120,000
N/
A
850
N/
A
290
40,000
N/
A
280
0.5
N/
A
3,500
N/
A
91,000
3,400
N/
A
1,200
N/
A
30,000
1,100
N/
A
Diptank
Operator
1.0
N/
A
1,800
N/
A
46,000
1,700
N/
A
580
N/
A
15,000
560
N/
A
High
Pressure/
High
Volume
Spray
Treatment
25
gal/
day
N/
A
580
4,800
N/
A
510
N/
A
190
1,600
N/
A
170
Wood
Treatment
50
gal/
day
N/
A
290
2,400
N/
A
260
N/
A
96
800
N/
A
86
100
gal/
day
N/
A
1,700
14,000
N/
A
1,500
N/
A
560
4,700
N/
A
500
Mushroom
House
1000
gal/
day
N/
A
170
1,400
N/
A
150
N/
A
56
470
N/
A
50
35
Table
11.
Short­
and
Intermediate­
Term
Handler
Risk
Estimates
for
Antimicrobial
Uses
of
Propiconazole
MOEs
for
Short­
Term
Exposure
MOEs
for
Intermediate­
Term
Exposure
Dermal
Total
Dermal
Total
Use
Site
Application
Method
Appl.

Rate
(%

ai
by
wt)
Amount
Handled
or
Treated
per
Day
Baseline
Gloves
Inhal.
Baseline
Gloves
Baseline
Gloves
Inhal.
Baseline
Gloves
100
gal/
day
N/
A
970
8,100
N/
A
870
N/
A
520
2,700
N/
A
290
Cooling
Tower
200
gal/
day
N/
A
490
4,100
N/
A
430
N/
A
160
1,400
N/
A
140
Pressure
Treatment
Treatment
Operator
1
N/
A
N/
A
260
82,000
N/
A
260
N/
A
86
27,000
N/
A
86
Treatment
Assistant
1
N/
A
N/
A
2,200
260,000
N/
A
2,200
N/
A
730
87,000
N/
A
730
N/
A­
not
applicable.
*
Gloves
are
not
applicable
to
painters
because
paint
products
containing
propiconazole
are
not
labeled
as
pesticides
(
i.
e.,
propiconazole
is
used
as
an
in­
can
preservative).
MOEs
in
bold
are
above
EPA's
level
of
concern.
36
b.
Post­
Application
Exposure
and
Risk
The
post­
application
occupational
risk
assessment
for
propiconazole
considers
exposure
to
agricultural
workers
re­
entering
areas
previously
treated
with
propiconazole
as
well
as
postapplication
exposure
from
use
of
propiconazole
as
a
wood
preservative.
EPA
identified
a
variety
of
post­
application
exposure
scenarios
by
the
type
of
activity
(
i.
e.,
weeding,
scouting,
or
hand
harvesting
crops;
grading
or
stacking
treated
lumber;
operating
chemical
equipment,
trim
saws,
etc.)
and
the
expected
level
of
contact.
Post­
application
exposure
levels
can
vary
over
time
according
to
the
type
of
worker
activity,
the
dissipation
of
chemical
residues
over
time,
and
the
nature
of
the
crop
or
item
that
was
treated.
The
Agency
estimated
post­
application
exposure
and
risk
using
dislodgeable
foliar
residue
(
DFR),
turf
transferable
residue
(
TTR),
and/
or
other
dissipation
or
postapplication
monitoring
data,
as
appropriate.

Agricultural
Uses.
Post­
application
exposure
for
agricultural
uses
of
propiconazole
was
evaluated
using
chemical­
specific
DFR/
TTR
data.
A
total
of
six
residue
dissipation
studies
are
available
for
corn,
peaches,
rice,
pecans,
ornamentals
and
turf.
The
DFR
data
have
been
extrapolated
to
similar
crops.
The
turf
TTR
data
have
been
used
to
complete
all
assessments
for
turf:
sod­
farm,
recreational
areas
and
golf
courses.
EPA
used
interim
transfer
coefficients
derived
from
Agricultural
Re­
entry
Task
Force
(
ARTF)
data
according
to
current
Agency
policy.

Worker
post­
application
risks
for
agricultural
uses
are
summarized
in
Table
12.
All
occupational
post­
application
short­
and
intermediate­
term
risks
are
below
the
Agency's
level
of
concern
on
the
day
of
pesticide
application
(
i.
e.,
MOEs
>
100
on
day
0)
except
for
hand­
harvesting
cut
flowers
on
day
0.
The
MOE
for
hand­
harvesting
cut
flowers
is
97
on
day
0
but
is
104
one
day
after
treatment.
Although
the
MOE
on
is
slightly
less
than
100
on
day
0,
the
MOE
of
97
is
within
the
negligible
risk
range,
and
thus
below
EPA's
level
of
concern.
The
current
restricted­
entry
interval
(
REI)
for
propiconazole
is
12
hours
on
some
labels;
which
is
consistent
with
the
Worker
Protection
Standard
(
WPS)
requirement
based
on
the
acute
toxicity
of
technical
propiconazole
(
Toxicity
Category
III).
The
propiconazole
REI
will
remain
12
hours
unless
otherwise
indicated
by
product­
specific
toxicity
data.

Table
12.
Summary
of
Post­
application
Worker
Risk
Estimates
for
Agricultural
Uses
of
Propiconazole
MOE
on
Day
of
Application
(
Day
0)

Crop
Activity
Transfer
Coefficient
(
cm2/
hr)
Maximum
Application
Rate
(
lb
ai/
A)
Short­
Term
Exposure
Intermediate
 
Term
Exposure
irrigating,
scouting,
handweeding
100
36000
12000
irrigating,
scouting
1500
2400
800
Celery,
Mint,
Wild
rice,
(
MN
only),
Barley,
Oats,
Rye,
Wheat,
Rice,
Peanuts
hand­
harvesting
2500
0.28
1400
500
37
Table
12.
Summary
of
Post­
application
Worker
Risk
Estimates
for
Agricultural
Uses
of
Propiconazole
MOE
on
Day
of
Application
(
Day
0)

Crop
Activity
Transfer
Coefficient
(
cm2/
hr)
Maximum
Application
Rate
(
lb
ai/
A)
Short­
Term
Exposure
Intermediate
 
Term
Exposure
hand­
weeding
100
110000
37000
irrigating,
scouting
1000
1100
3700
Corn
(
field,
pop,
sweet),
Sunflower
De­
tasseling,
handharvesting
17000
0.1125
700
220
irrigating,
scouting
1000
2600
860
hand­
weeding,
hand
harvesting,
hand­
pruning,
1500
1700
570
Stone
Fruits,
Peaches,
Non­
bearing
Apples,

Thinning
3000
0.1125
860
290
irrigation,
scouting,
handweeding
1000
1300
430
Non­
bearing
Citrus
hand­
pruning,
thinning
3000
0.225
430
140
irrigation,
hand­
weeding
100
35000
12000
scouting,
irrigation
1300
2700
900
Bananas,
Plantains
hand­
harvesting,,
thinning,
hand­
weeding/
pruning
2000
0.084
1700
600
scouting,
hand­
weeding/
pruning,
irrigation,
thinning
400
4300
1400
Non­
bearing
Blueberries
hand­
pruning
1500
0.169
1200
380
pruning,
tying
110
7100
2040
transporting,
moving
potted
plants
400
2000
560
150
97
Ornamentals
(
Woody
and
Herbaceous)
plants
hand­
harvesting
(
cut
flowers)
Short­
term
5100
Intermediateterm
2700
0.37
170
104
hand­
weeding,
thinning,
irrigating,
scouting
500
5200
1700
Pecans,
Non­
bearing
Hazelnuts
Hand­
pruning,
thinning
2500
0.225
1000
340
Turf
maintenance
3400
1.8
1800
600
Turf
(
grasses
grown
for
seed,
golf
courses,
sod
farms)
hand­
weeding/
harvesting
transplanting,
hand­
harvest
mechanical
harvesting
6800
1.8
900
300
38
Antimicrobial
Uses.
EPA
evaluated
post­
application
to
machinists
using
metalworking
fluids
containing
propiconazole
and
to
sawmill
workers
handling
lumber
treated
with
propiconazole.
Exposure
to
machinists
was
estimated
using
the
best
available
information.
Dermal
exposure
was
simulated
using
the
hand­
immersion
model
ChemSTEER,
which
considers
percent
active
ingredient
and
film
thickness.
Inhalation
exposure
was
estimated
using
the
Occupational
Safety
and
Health
Administration
(
OSHA)
permissible
exposure
limit
(
PEL)
for
oil
mist.
Postapplication
worker
exposure
for
antimicrobial
use
of
propiconazole
as
a
wood
preservative
was
evaluated
using
surrogate
data
from
a
study
based
on
another
wood
preservative,
DDAC,
which
measured
worker
exposure
performing
routine
tasks
at
several
sawmills/
planar
mills
in
Canada.
The
DDAC
study
monitored
both
inhalation
and
dermal
exposure.
EPA
also
used
surrogate
data
from
a
study
on
chromated
copper
arsenic
(
CCA)
conducted
by
the
American
Chemistry
Council.
This
study
monitored
both
inhalation
and
dermal
exposure
during
post­
application
activities
such
as
stacker
operator
and
loader
operator.
MOEs
for
post­
application
worker
exposure
to
metalworking
fluids
and
wood
preservatives
are
summarized
in
Table
13.

Table
13.
Summary
of
Post­
application
Worker
Risk
Estimates
for
Propiconazole
Used
in
Metalworking
Fluids
and
Wood
Preservative
MOE
for
Short­
Term
Exposure
on
Day
of
Application
(
Day
0)
MOE
for
Intermediate­/
Long­
Term
Exposure
on
Day
of
Application
(
Day
0)
Worker
Activity
Dermal
Inhalation
Total
Dermal
Inhalation
Total
Metalworking
Fluid
Machinist
5,100
75,000
4,800
1,700
25,000
1,600
Wood
Preservative
Grader
2,700
110,000
2,600
890
38,000
870
Trim
Saw
Operator
6,100
56,000
5,500
2,000
19,000
1,800
Millwright
660
59,000
650
220
20,00
220
Clean
Up
Crew
150
5,600
150
51
1,900
49
Pressure
Treatment
 
all
scenarios
710
130,000
710
240
44,000
240
MOEs
in
bold
are
above
EPA's
level
of
concern.

c.
Incident
Reports
The
Agency
reviewed
available
sources
of
human
incident
data
for
incidents
relevant
to
propiconazole.
The
following
sources
were
used:
1)
The
Office
of
Pesticide
Programs'
(
OPP)
Incident
Data
System
(
IDS)
consisting
of
reports
submitted
to
EPA
by
registrants,
other
federal
and
state
health
and
environmental
agencies
and
the
public
since
1992;
2)
Poison
Control
Center
Data
covering
the
years
1993
through
2003
for
all
pesticides;
3)
California
Department
of
Pesticide
Regulation's
pesticide
poisoning
surveillance
program
consisting
of
reports
from
physicians
of
39
illness
suspected
of
being
related
to
pesticide
exposure
since
1982;
4)
National
Pesticide
Information
Center
(
NPIC)
data
that
provides
a
ranking
of
the
top
200
active
ingredients
for
which
telephone
calls
were
received
between
1984
and
1991;
and
5)
National
Institutes
of
Occupational
Safety
and
Health
(
NIOSH)
Sentinal
Event
Notification
System
for
Occupational
Risks
(
SENSOR)
that
provides
surveillance
in
seven
states
from
1998
through
2002.
EPA's
review
of
the
human
incident
data
for
propiconazole
can
be
found
in
the
July
26,
2005
document,
Review
of
Propiconazole
Incident
Reports.

All
of
the
sources
listed
above,
except
for
NPIC,
contained
information
relevant
to
propiconazole.
The
IDS
contained
numerous
incidents,
most
of
which
involved
symptoms
such
as
skin
rash,
itching,
and
irritation
and
respiratory
effects
such
as
difficulty
breathing.
However,
this
database
contained
little
information
about
the
disposition
of
the
reported
cases.
Reports
submitted
to
the
IDS
represent
anecdotal
reports
or
allegations.
Poison
Control
Center
Data
listed
13
occupational
exposure
incidents
among
adults
and
older
children,
63
nonoccupational
exposure
incidents
among
adults
and
older
children,
and
13
exposures
to
children
under
6
years
old.
Only
a
small
number
of
these
incidents
required
treatment
in
a
health
care
facility,
and
none
were
considered
life
threatening
or
required
hospitalization.
The
most
common
symptoms
reported
were
headache,
skin
irritation,
erythema,
vomiting,
ataxia,
dizziness,
coughing,
and
difficulty
breathing.
In
general,
in
comparison
to
other
pesticides
for
which
Poison
Control
Center
Data
are
available,
propiconazole
appears
to
be
less
hazardous
with
less
than
one
percent
of
reported
propiconazole
cases
being
symptomatic,
compared
to
approximately
70%
of
all
pesticide
cases.
The
Agency
also
reviewed
detailed
descriptions
of
13
cases
submitted
to
the
California
Pesticide
Illness
Surveillance
Program,
and
propiconazole
was
deemed
to
be
the
responsible
for
health
effects
in
8
of
these
cases.
Reported
symptoms
included
difficulty
breathing,
eye
and
skin
irritation,
headache
and
vomiting.
Propiconazole
was
not
reported
on
the
list
of
the
top
200
chemicals
with
incidents
reported
to
NPIC.
Propiconazole
was
associated
with
two
cases
out
of
a
total
of
4,221
cases
reported
to
NIOSH
SENSOR
between
1998
and
2002.
Both
cases
were
as
a
result
of
drift;
symptoms
included
nausea,
vomiting,
gastrointestinal
pain,
difficulty
breathing,
and
throat
irritation.

In
general,
in
conclusion
from
the
review
of
the
IDS,
it
appears
that
a
majority
of
cases
involved
skin
symptoms
such
as
rash,
itching,
skin
irritation
and
respiratory
effects.
Poison
Control
Center
Data
tends
to
support
the
IDS
results
with
dermal
irritation,
erythema,
and
difficulty
breathing
being
among
the
most
common
effects
reported.

B.
Environmental
Fate
and
Effects
Risk
Assessment
A
summary
of
the
Agency's
environmental
fate
and
effects
risk
assessment
is
presented
below.
For
detailed
discussion
of
all
aspects
of
the
environmental
risk
assessment,
please
see
the
documents,
Environmental
Fate
and
Effects
Division
Risk
Assessment
for
the
Reregistration
of
Propiconazole,
dated
November
29,
2005,
Environmental
Fate
and
Effects
Division
Revised
RED
for
the
Reregistration
of
Propiconazole,
dated
June
30,
2006,
and
Terrestrial
Plant
Runoff
Risk
Assessment
for
Propiconazole
on
Turf
Using
PRZM,
dated
July
14,
2006.
These
documents
are
available
on
the
internet
(
www.
regulations.
gov)
and
in
the
public
docket
under
docket
number
EPA­
HQ­
OPP­
2005­
0497.
This
risk
assessment
was
refined
and
updated
to
incorporate
public
comments
submitted
during
Phase
3
of
the
public
participation
process
and
additional
studies
submitted
by
the
registrant.
Major
changes
to
the
risk
assessment
include
the
following:
40
 
Incorporation
of
information
on
dissipation
and
degradation
of
propiconazole
in
the
environment,
 
Revision
of
estimated
environmental
concentrations
(
EECs)
for
propiconazole
in
water
for
wheat
and
rice
and
in
various
food
items
for
turf
and
rice,
 
Use
of
EPA's
T­
REX
Model
to
estimate
risk
quotients
(
RQs)
for
birds
and
mammals;
and
 
Revision
of
Risk
Quotients
(
RQs)
for
aquatic
and
terrestrial
organisms.

1.
Environmental
Fate
and
Transport
Propiconazole
appears
to
be
persistent
and
moderately
mobile
to
relatively
immobile
in
most
soil
and
aqueous
environments.
Propiconazole
degradation
in
the
aquatic
environment
appears
to
be
dependent
solely
on
aqueous
photolysis
in
the
presence
of
photo
sensitizers
that
are
quite
common
in
photolysis
studies.
In
soil
environments,
propiconazole
dissipation
appears
to
be
dependent
on
incorporation
or
binding
to
soil
organic
matter
content.

Laboratory
and
terrestrial
field
dissipation
data
indicate
that
propiconazole
is
stable
in
soil
and
aqueous
environments.
Propiconazole
was
stable
to
hydrolysis;
aqueous
photolysis;
soil
photolysis;
aerobic
aquatic
metabolism,
aerobic
soil
metabolism,
and
anaerobic
aquatic
metabolism.
The
terrestrial
field
dissipation
data
were
consistent
with
laboratory
data
with
reported
half­
lives
of
greater
than
100
days
for
four
soil
textures.
However,
in
supplemental
aquatic
dissipation
studies
using
basin
irrigation
and
flow­
through
irrigation
systems
in
rice
fields,
propiconazole
was
found
to
dissipate
rapidly
with
a
half­
life
of
less
than
5
days.
Aqueous
photolysis
studies
using
sensitizers
indicated
rapid
degradation
with
a
half­
life
of
less
than
1
day
for
propiconazole,
which
appears
to
also
be
the
case
in
rice
fields.
Furthermore,
aquatic
metabolism
and
dissipation
studies
indicate
propiconazole
dissipates
by
incorporation
of
binding
to
the
organic
matter
content
of
soil/
sediment.

Propiconazole
mobility
in
soil
appears
to
be
dependent
on
the
soil's
organic
matter
content.
In
general,
propiconazole
appears
to
be
moderately
mobile
in
soils
with
low
organic
matter
content
and
relatively
immobile
in
soils
with
high
organic
matter
content.
Therefore,
propiconazole
may
reach
groundwater
in
soils
with
low
organic
content.
More
importantly,
propiconazole
may
contaminate
surface
water
through
off­
site
runoff
and
spray
drift.

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
acute
and
chronic
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
14
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
41
potential
for
adverse
effects
to
non­
target
organisms.
For
a
more
detailed
explanation
of
the
ecological
risks
posed
by
the
use
of
propiconazole,
refer
to
the
document,
Environmental
Fate
and
Effects
Division
Revised
RED
for
the
Reregistration
of
Propiconazole,
dated
June
30,
2006.

Table
14.
EPA's
Levels
of
Concern
(
LOCs)
and
Risk
Presumptions
If
a
calculated
RQ
is
greater
than
the
LOC
presented,
then
the
Agency
presumes
that 
LOC
terrestrial
animals
LOC
aquatic
animals
LOC
Plants
Acute
Risk
 
there
is
potential
for
acute
risk;
regulatory
action
may
be
warranted
0.5
0.5
1.0
Acute
Listed
(
Endangered
and
Threatened)
Species
 
listed
species
may
be
adversely
affected
0.1
0.05
1.0
Chronic
Risk
 
there
is
potential
for
chronic
risk
1
1
NA
a.
Terrestrial
Organisms
Exposure
to
Birds
and
Mammals.
The
Agency
assessed
exposure
to
terrestrial
organisms
by
first
predicting
the
amount
of
propiconazole
residues
found
on
animal
food
items
and
then
by
estimating
the
amount
of
pesticide
consumed
by
using
information
on
typical
food
consumption
by
various
species
of
birds
and
mammals.
The
amount
of
residues
on
animal
feed
items
are
based
on
the
Fletcher
nomogram
(
a
model
developed
by
Fletcher,
Hoerger,
Kenaga,
et
al.),
a
default
half­
life
of
35
days
and/
or
a
chemical­
specific
foliar
dissipation
half­
life,
the
current
maximum
application
rate
for
propiconazole,
the
maximum
number
of
applications
per
year
(
when
specified),
and
the
minimum
interval
between
applications.
For
crops
with
more
than
one
application,
EPA
used
the
T­
REX
computer
model
to
account
for
residue
dissipation
between
pesticide
applications.
EPA
modeled
the
mean
and
maximum
residues
of
propiconazole
in
various
food
items
immediately
after
application
of
propiconazole
to
representative
crops.
EPA
used
the
maximum
EECs
and
standard
food
consumption
values
to
estimate
dietary
exposure
levels
for
birds
and
mammals.
EECs
were
determined
for
the
following
food
categories:
short
grass,
tall
grass,
broadleaf
forage/
small
insects,
and
fruit,
pods,
seeds/
large
insects.
The
EEC
values
on
these
food
items
may
be
found
in
the
June
30,
2006
document,
Environmental
Fate
and
Effects
Division
Revised
RED
for
the
Reregistration
of
Propiconazole.

As
mentioned
above,
EPA
used
a
default
35­
day
foliar
dissipation
half­
life
to
derive
EECs.
EPA
has
limited
chemical­
specific
data
for
foliar
dissipation
in
wheat,
from
field
trials
for
propiconazole.
These
data
were
used
as
a
surrogate
for
all
potential
vegetative
feed
forms
for
birds
and
mammals.
However,
there
are
key
uncertainties
in
these
data.
In
the
propiconazole
field
trials
for
wheat,
only
a
few
samples
were
taken
at
the
time
of
propiconazole
application
allowing
residue
dissipation
could
be
determined
over
time.
Further,
these
field
trials
did
not
record
local
weather
data,
which
can
affect
dissipation.
EPA
took
the
95th
percentile
upper
confidence
limit
on
the
mean
foliar
dissipation
half­
life
to
derive
a
14.4
day
foliar
dissipation
half­
life.
This
value
was
used
to
give
a
lower
range
for
EECs
for
certain
crops.
The
Agency
is
requiring
a
confirmatory
foliar
dissipation
study
as
part
of
this
RED.
This
study
would
measure
dissipation
of
propiconazole
over
time
from
foliage
of
several
representative
crop
groups.

Toxicity
to
Birds
and
Mammals.
EPA
determines
the
potential
effects
a
pesticide
can
42
produce
in
a
terrestrial
organism
by
reviewing
guideline
toxicity
studies
that
describe
acute
and
chronic
effects
of
the
chemical
on
birds
and
mammals.
Table
15
summarizes
the
toxicity
effects
and
reference
values
used
to
assess
potential
risks
to
mammals
and
birds
from
unintentional
exposure
to
propiconazole.
These
toxicity
values
were
used
to
calculate
RQs
based
both
on
the
dose
(
in
terms
of
mg/
kg/
body
weight
given
in
a
gavage
study)
and
diet
(
in
terms
of
mg/
kg
of
food
consumed).
Dose­
based
RQs
assumes
that
the
uptake
and
absorption
of
a
compound
from
a
dose
given
by
oral
gavage
is
similar
to
the
dose
the
organism
receives
in
the
field
from
eating
food
items
containing
residues
of
the
compound.
However,
a
gavage
dose
represents
a
short­
term
highintensity
exposure,
which
is
likely
to
be
different
from
a
typical
dose
level
and
duration
in
the
field.
Dietary­
based
RQs
assume
that
the
dose
of
a
compound
administered
in
a
laboratory
feeding
study
is
similar
to
the
level
of
residues
the
organism
consumes
in
the
field.
However,
the
diet
in
a
laboratory
feeding
study
differs
significantly
from
the
diet
of
an
animal
foraging
in
for
food
the
field.

Table
15.
Toxicity
Reference
Values
for
Mammals
and
Birds
for
Propiconazole.

Exposure
Scenario
Species
Toxicity
Reference
Value
Toxicity
Category
or
Effect
Mammals
Acute
Mouse
LD50
=
729
mg
ai/
kg
bwt
Category
III
Chronic
Rat
NOAEL
=
43
mg/
kg
bwt
Reduced
body
weight
gain,
liver
changes
in
F0
generation,
decreased
offspring
survival
&
body
weight,
hepatic
lesions
Birds
Acute
LD50
=
2825
mg
ai/
kg
bwt
Practically
non­
toxic
Chronic
Bobwhite
quail
NOAEC
=
1000
mg/
kg
diet
No
treatment­
related
effects
LD50
­
Median
Lethal
Dose
or
Concentration,
statistically
derived
single
dose
or
concentration
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
NOAEL
 
no
observed
adverse
effect
level,
dose
of
compound
in
mg
ai/
kg
body
weight/
day;
NOAEC
 
lowest
observed
adverse
effect
concentration
or
concentration
of
compound
in
food
associated
with
adverse
effects,
dose
in
mg
ai/
kg
food
consumed.

Acute
mammalian
RQs
for
herbivores/
insectivores
were
calculated
on
the
basis
of
dose
(
mg/
kg
body
weight/
day
by
gavage).
Acute
dose­
based
RQs
assuming
a
default
35
day
half­
life
are
below
the
LOC
for
all
propiconazole
uses
except
RQs
for
turf
(
Table
16a).
The
RQs
for
turf
exceeded
the
listed
species
LOC
for
mammals
in
all
food
categories
except
for
fruits/
pods/
large
insects
and
grain
(
represented
by
the
lower
end
of
range
of
RQs
presented).
However,
RQs
based
on
multiple
applications
of
propiconazole
to
turf
exceeded
the
acute
LOC
of
0.5
only
for
15
g
and
35
g
smaller
mammals
in
the
short
grass
food
category.
Remaining
RQs
did
not
exceed
any
levels
of
concern.
43
Table
16a.
Acute
RQs
for
Terrestrial
Mammals
Exposed
to
Propiconazole
(
35
day
half­
life).*

Ranges
of
Acute
RQs**
by
Body
Weight
Exposure
Scenario
(
Crop)
15
g
35
g
1000
g
Barley,
Rye,
Triticale
0.0003
 
0.02
0.00017
 
0.01
0.000036
 
0.003
Wheat
0.00
 
0.024
0.00
 
0.017
0.00
 
0.0038
Pecan,
Grasses
grown
for
seed
0.00
 
0.09
0.00
 
0.08
0.00
 
0.04
Corn,
Celery
0.00
 
0.08
0.00
 
0.053
0.00
 
0.012
Peanut
0.00
 
0.06
0.00
 
0.05
0.00
 
0.03
Rice,
Wild
Rice
0.00
 
0.04
0.00
 
0.04
0.00
 
0.02
Stone
Fruits
0.00
 
0.07
0.00
 
0.06
0.00
 
0.03
Turf
and
Ornamentals,
ground
cover
0.01
 
0.77
0.01
 
0.66
0.00
 
0.35
Turf
and
Ornamentals,
lawns,
turf,
golf
courses
0.01
 
0.7
0.01
 
0.6
0.00
 
0.32
Turf
and
Ornamentals,
sod
farm
0.01
 
0.61
0.01
 
0.52
0.00
 
0.28
*
Acute
RQs
are
based
on
an
EPA
default
35
foliar
dissipation
half­
life.
**
Ranges
of
acute
RQs
are
based
on
a
variety
of
food
items,
including
short
grass;
tall
grass;
broadleaf
plants
and
small
insects;
and
fruits,
pods,
seeds,
and
large
insects.
RQs
in
bold
are
above
EPA's
level
of
concern
(
LOC).

For
crops
where
RQs
exceeded
the
Agency's
LOC
(
Table
16a),
EPA
revised
the
dosebased
RQs
by
using
the
limited
chemical­
specific
data
on
foliar
dissipation
half­
life
previously
described.
EPA
ran
the
T­
REX
model
using
a
14.4
day
foliar
dissipation
half­
life
derived
from
propiconazole
specific
data,
rather
than
the
default
foliar
dissipation
half­
life
of
35
days
used
in
the
original
screening­
level
assessment.
Revised
RQs
are
presented
in
Table
16b
below
and
show
no
acute
risks
of
concern
for
mammals
except
for
the
smallest
mammals
feeding
on
short
grass.
In
addition,
there
are
no
listed
species
risks
of
concern
for
all
weight
classes
of
mammals
feeding
on
fruits,
pods,
seeds/
large
insects.
However,
the
listed
species
LOC
of
0.1
is
exceeded
for
all
weight
classes
of
mammals
feeding
on
short
grass,
tall
grass,
and
broadleaf
plants
and
small
insects.

Table
16b.
Revised
Acute
RQs
for
Terrestrial
Mammals
Exposed
to
Propiconazole
(
14.4
day
half­
life).*

Ranges
of
Acute
RQs**
by
Body
Weight
Exposure
Scenario
(
Crop)
15
g
35
g
1000
g
Turf
and
Ornamentals,
ground
cover
0.01
 
0.57
0.01
 
0.49
0.00
 
0.26
Turf
and
Ornamentals,
lawns,
turf,
golf
courses
0.01
 
0.48
0.01
 
0.41
0.00
 
0.22
Turf
and
Ornamentals,
sod
farm
0.01
 
0.39
0.00
 
0.34
0.00
 
0.18
*
Based
on
chemical­
specific
14.4
day
foliar
dissipation
half­
life.
**
Represent
variety
of
food
items,
including
short
grass;
tall
grass;
broadleaf
plants
and
small
insects;
and
fruits,
pods,
seeds,
and
large
insects
RQs
in
bold
>
LOC.
44
Chronic
risks
to
mammals
based
on
the
default
35­
day
half­
life
were
calculated
using
both
the
dietary­
and
dose­
based
RQs.
Dietary­
based
RQs,
not
presented
in
the
table
below,
only
exceeded
the
chronic
LOCs
for
multiple
applications
to
turf
and
ranged
from
1.1
to
2.6.
However,
dose­
based
chronic
RQs
(
Table
17a)
were
as
high
as
13
for
mammals
foraging
in
short
grass
when
EPA
assumed
multiple
applications
of
propiconazole
to
the
crops
listed
below.
Chronic
RQs
only
begin
to
exceed
LOCs
after
the
3rd
application
and
no
chronic
LOCs
are
exceeded
after
2
applications.
Acute
risks
would
also
be
lower
based
on
fewer
applications.
All
other
exposure
scenarios
resulted
in
RQs
below
the
Agency's
LOC
and
are
therefore
not
presented
in
Table
17a.

Table
17a.
Chronic
Dose­
Based
RQs
for
Terrestrial
Mammals
Exposed
to
Propiconazole
(
35
day
half­
life)*

Ranges
of
Chronic
RQs
**
by
Body
Weight
Exposure
Scenario
(
Crop)
15
g
35
g
1000
g
Pecan,
Grasses
grown
for
seed
0.02
­
1.51
0.02
 
1.29
0.0
 
0.69
Stone
Fruits
0.02
 
1.13
0.01
 
0.96
0.01
 
0.52
Turf
and
Ornamentals,
ground
cover
0.18
 
13
0.16
 
11
0.08
 
6
*
Based
on
an
EPA
default
35
foliar
dissipation
half­
life.
**
Represent
a
variety
of
food
items,
including
short
grass;
tall
grass;
broadleaf
plants
and
small
insects;
and
fruits,
pods,
seeds,
and
large
insects.
RQs
in
bold
are
above
EPA's
level
of
concern
(
LOC).

When
the
Agency
revised
the
chronic
dose­
based
RQs
using
chemical­
specific
foliar
dissipation
half­
life
data,
almost
all
pecan,
stone
fruit,
and
grasses
grown
for
seed
chronic
RQs
do
not
exceed
the
Agency's
chronic
LOC
of
1
except
for
the
smallest
weight
class
of
mammal
feeding
on
short
grass
in
pecans
(
the
RQ
only
barely
exceeds
at
1.04).
For
turf,
chronic
RQs
do
not
exceed
the
Agency's
chronic
LOC
for
all
weight
classes
of
mammals
feeding
on
fruits,
pods,
large
insects/
seeds;
however,
turf
RQs
exceed
the
Agency's
chronic
LOC
for
mammals
feeding
on
short
and
tall
grass,
and
broadleaf
plants
and
small
insects.

Table
17b.
Revised
Chronic
Dose­
Based
RQs
for
Terrestrial
Mammals
Exposed
to
Propiconazole
(
14.4
day
half­
life)
*
Ranges
of
Chronic
RQs**
by
Body
Weight
Exposure
Scenario
(
Crop)
15
g
35
g
1000
g
Pecan,
Grasses
grown
for
seed
0.01
 
1.04
0.01
 
0.89
0.01
 
0.47
Stone
Fruits
0.00
 
0.89
0.01
 
0.76
0.01
 
0.41
Turf
and
Ornamentals,
ground
cover
0.13
 
9.64
0.11
 
8.23
0.06
 
4.41
*
Based
on
a
chemical­
specific
14.4
day
foliar
dissipation
half­
life.
**
Represent
a
variety
of
food
items,
including
short
grass;
tall
grass;
broadleaf
plants
and
small
insects;
and
fruits,
pods,
seeds,
and
large
insects.
RQs
in
bold
are
above
EPA's
level
of
concern
(
LOC).

Avian
acute
RQs
based
on
the
default
35­
day
foliar
dissipation
half­
life
do
not
exceed
the
Agency's
LOC
of
0.5
except
RQs
for
the
smallest
weight
class
of
birds
feeding
on
short
grass
45
derived
from
maximum
residues
from
multiple
applications
to
turf
and
ornamental
uses
(
see
bolded
numbers
in
Table
18a).
When
these
RQs
were
revised
using
chemical­
specific
foliar
dissipation
half­
life
data,
only
the
RQ
of
0.53
for
smallest
weight
class
of
bird
feeding
on
short
grass
exceeds
the
LOC
of
0.5
(
Table
18b).
However,
RQs
based
on
predicted
maximum
residues
and
multiple
applications
to
turf
and
ornamentals
exceed
the
listed
species
LOC
of
0.1
for
all
weight
classes
of
birds
feeding
on
short
grass
and
tall
grass
and
for
smaller
birds
feeding
on
broadleaf
forage
and
small
insects
based.
For
RQs
based
on
predicted,
mean
residues
resulting
from
multiple
applications
to
turf
and
ornamentals,
only
birds
feeding
on
short
grass
exceed
the
endangered
species
LOC.
No
other
exposure
scenarios
result
in
RQs
that
exceed
the
Agency's
LOCs.
Acute
RQs
are
summarized
in
Tables
18a
and
b
below;
ranges
are
based
on
a
variety
of
food
items,
weight
classes
of
birds,
and
number
of
applications.

Dietary­
based
avian
chronic
RQs
presented
in
Table
18a
show
that
the
chronic
LOC
is
slightly
exceeded
for
use
of
propiconazole
on
turf.
However,
chronic
data
for
birds
showed
no
treatment­
related
effects
at
any
of
the
test
levels
up
to
1000
mg/
kg
diet
and,
as
such,
a
LOAEC
could
not
be
determined.
Consequently,
the
actual
NOAEC
could
be
much
greater
than
that
observed
in
the
study
used
to
assess
chronic
avian
risk
and
the
RQs
could
be
lower.
Dietary­
based
chronic
avian
RQs
only
exceeded
the
LOC
for
multiple
applications
to
turf
and
the
highest
RQ
was
1.3
(
Chronic
LOC
is
1).
In
addition,
these
RQs
have
been
further
refined
by
using
chemicalspecific
foliar
dissipation
half­
life
data
resulting
in
a
maximum
RQ
of
only
1.02
(
Table
18a).
Based
on
the
lack
of
observed
effects
in
the
chronic
study,
and
the
fact
that
RQs
based
on
this
study
only
slightly
exceed
the
LOC,
the
Agency
does
not
consider
there
to
be
chronic
avian
risks
of
concern
for
propiconazole.

Table
18a.
Acute
and
Chronic
RQs
for
Birds
Exposed
to
Propiconazole
(
35
day
half­
life).*

Ranges
of
Acute
RQs**
Ranges
of
Chronic
RQs**
Exposure
Scenario
(
Crop)
Based
on
Maximum
Residues
Based
on
Mean
Residues
Based
on
Single
Application
Based
on
Multiple
Applications
Barley,
Rye,
Triticale
0.00
 
0.02
0.00
 
0.01
0.0016
 
0.027
NA
Wheat
0.00
 
0.02
0.00
 
0.00
0.0021
 
0.034
0.0011
 
0.02
Pecan,
Grasses
grown
for
seed
0.00
 
0.08
0.00
 
0.03
0.0034
 
0.054
0.009
 
0.149
Corn,
Celery
0.00
 
0.03
0.00
 
0.01
0.0
 
0.03
0.0
 
0.05
Peanut
0.00
 
0.06
0.00
 
0.02
0.00
 
0.05
0.01
 
0.1
Rice,
Wild
Rice
0.00
 
0.1
0.00
 
0.03
0.0034
 
0.054
0.004
 
0.08
Stone
Fruits
0.00
 
0.061
0.00
 
0.02
0.0017
 
0.027
0.007
 
0.112
Turf
and
Ornamentals,
ground
cover
0.00
 
0.70
0.00
 
0.25
0.027
 
0.427
0.08
 
1.3
Turf
and
Ornamentals,
lawns,
turf,
golf
courses
0.00
 
0.63
0.00
 
0.22
0.027
 
0.427
0.074
 
1.18
46
Table
18a.
Acute
and
Chronic
RQs
for
Birds
Exposed
to
Propiconazole
(
35
day
half­
life).*

Ranges
of
Acute
RQs**
Ranges
of
Chronic
RQs**
Exposure
Scenario
(
Crop)
Based
on
Maximum
Residues
Based
on
Mean
Residues
Based
on
Single
Application
Based
on
Multiple
Applications
Turf
and
Ornamentals,
sod
farm
0.00
 
0.54
0.00
 
0.19
0.027
 
0.427
0.06
 
1.02
*
Based
on
an
EPA
default
35
foliar
dissipation
half­
life.
**
Represent
a
variety
of
food
items,
including
short
grass;
tall
grass;
broadleaf
plants
and
small
insects;
and
fruits,
pods,
seeds,
and
large
insects.
RQs
are
also
based
on
different
weight
classes
of
birds
and
single
and
multiple
applications.
RQs
in
bold
are
above
EPA's
level
of
concern
(
LOC).

Table
18b.
Revised
Acute
and
Chronic
RQs
for
Birds
Exposed
to
Propiconazole
(
14.4
day
half­
life).*

Exposure
Scenario
(
Crop)
Ranges
of
Acute
RQs
(
based
on
multiple
applications)
Ranges
of
Chronic
RQs
(
based
on
multiple
applications)

Turf
and
Ornamentals,
ground
cover
0.00
 
0.53
0.06
 
0.96
Turf
and
Ornamentals,
lawns,
turf,
golf
courses
0.00
 
0.45
0.05
 
0.81
Turf
and
Ornamentals,
sod
farm
0.00
 
0.37
0.04
 
0.66
*
Based
on
a
chemical­
specific
14.4
day
foliar
dissipation
half­
life.
**
Represent
a
variety
of
food
items,
including
short
grass;
tall
grass;
broadleaf
plants
and
small
insects;
and
fruits,
pods,
seeds,
and
large
insects.
RQs
are
also
based
on
different
weight
classess
of
birds
and
single
and
multiple
applications.
RQs
in
bold
are
above
EPA's
level
of
concern
(
LOC).

Non­
Target
Insects
&
Other
Terrestrial
Organisms.
EPA
currently
does
not
estimate
RQs
for
terrestrial
non­
target
insects.
In
addition,
there
were
no
data
on
non­
target
terrestrial
insects,
such
as
honeybees.
Propiconazole
does
not
appear
to
have
any
adverse
effects
on
soil
microbes
as
evidenced
by
soil
biochemical
analysis.
Also,
propiconazole
showed
no
toxicity
to
earthworms.

Non­
Target
Terrestrial
Plants.
Terrestrial
plants
inhabiting
dry
and
semi­
aquatic
(
wetland)
areas
may
be
exposed
to
pesticides
from
runoff
and/
or
spray
drift.
Therefore,
EPA
estimated
exposure
to
terrestrial
plants
using
the
Terr­
PLANT
model
based
on
the
maximum
label
application
rate,
a
default
amount
of
runoff
based
on
solubility,
and
default
assumptions
regarding
drift.
EECs
for
non­
target
plants
resulting
from
a
single
application
of
propiconazole
are
presented
in
Table
19.
47
Table
19.
Propiconazole
EECs
derived
from
the
Terr­
PLANT
screening
model
(
and
based
on
a
single
application)

Crop
Application
Rate
(
lbs
ai/
A)
Application
Method
Total
loading
to
adjacent
areas
(
lb
ai/
A)
Total
loading
to
semi­
aquatic
areas
(
lb
ai/
A)
Drift
EEC
(
lb
ai/
A)

Ground
spray
0.0034
0.0236
0.0011
Stone
fruit
0.1125
Aerial
spray
0.0079
0.0281
0.0056
Ground
spray
0.0024
0.0168
0.008
Wheat
0.08
Aerial
spray
0.0056
0.020
0.004
Ground
spray
0.0068
0.0473
0.0023
Grasses
grown
for
seed,
forage,
fodder
grasses
0.225
Aerial
spray
0.0158
0.0563
0.0113
Ground
spray
0.0534
0.3738
0.178
Turf
and
ornamentals
 
ground
cover
1.78
Chemigation
0.12446
0.4450
0.089
EPA
determines
the
potential
effects
a
pesticide
can
produce
in
nontarget
plants
by
reviewing
guideline
toxicity
studies
that
describe
acute
effects
toxicity
information
for
various
terrestrial
plants.
Tier
2
terrestrial
plant
data
are
available
to
show
effect
of
technical
propiconazole
on
both
seedling
emergence
and
vegetative
vigor.
The
seedling
emergence
study
considered
percent
emergence,
plant
height,
and
plant
dry
weight
to
determine
the
EC25
and
NOAEC
for
each
of
the
species
tested
at
use
rates
of
0.0185,
0.056,
0.167,
0.5,
and
1.5
lb
ai/
A.
The
monocots
tested
included
onion,
corn,
oats,
and
ryegrass.
Although
the
dicot
species
included
carrot,
soybean,
lettuce,
cucumber,
tomato,
and
cabbage,
only
cabbage
showed
a
dose
response
sufficient
to
derive
an
EC25.
The
other
dicot
species
appeared
to
be
unaffected
by
the
treatments.
Therefore,
for
the
purposes
of
risk
assessment,
the
EC25
is
assumed
to
be
>
1.5
lb
ai/
A
for
all
of
these
species
except
cabbage.
The
EC25
for
cabbage
is
0.18
lb
ai/
A,
and
the
NOAEC
is
0.056
lb
ai/
A
based
on
plant
dry
weight.
The
vegetative
vigor
study
was
performed
using
the
same
species
and
application
rates
as
the
seedling
emergence
studies.
Plant
height
and
plant
dry
weight
were
the
parameters
measured
to
determine
a
dose­
response.
Ryegrass
was
determined
to
be
the
most
sensitive
monocot
based
on
plant
height,
with
an
EC25
of
0.315
lb
ai/
A
and
a
NOAEC
of
0.0185
lb
ai/
A.
As
with
the
seedling
emergence
study,
cabbage
was
the
most
sensitive
dicot
based
on
plant
dry
weight,
with
an
EC25
of
0.039
lb
ai/
A
and
a
NOAEC
of
0.056
lb
ai/
A.
These
data
are
summarized
in
Table
20
below.

Table
20.
Acute
Toxicity
of
Propiconazole
to
Terrestrial
Plants
Species
EC25
(
lb
ai/
A)
NOAEC/
EC05
(
lb
ai/
A)
Effect
Monocot
Onion,
corn,
oat,
rygrass
>
1.5
1.5
Seedling
emergence:
emergence,
shoot
length,
dry
weight
Ryegrass
0.315
0.0185
Vegetative
vigor:
plant
height
48
Table
20.
Acute
Toxicity
of
Propiconazole
to
Terrestrial
Plants
Species
EC25
(
lb
ai/
A)
NOAEC/
EC05
(
lb
ai/
A)
Effect
Dicot
0.18
0.056
Seedling
emergence:
plant
dry
weight
Cabbage
0.039
0.056
Vegetative
vigor:
plant
dry
weight
EC25
 
25%
Effect
Concentration,
statistically
derived
single
dose
or
concentration
that
can
be
expected
to
cause
effects
in
25%
of
the
test
organisms;
EC
05
 
5%
Effect
Concentration,
statistically
derived
single
dose
or
concentration
that
can
be
expected
to
cause
effects
in
5%
of
the
test
organisms;
NOAEC
 
No
adverse
effects
concentration.

Although
propiconazole
is
a
fungicide,
it
poses
a
potential
risk
to
terrestrial
plants
for
some
uses.
The
Agency
calculated
RQs
for
seedling
emergence
effects
(
using
total
exposure
from
drift
and
runoff)
and
RQs
for
vegetative
vigor
for
exposure
via
spray
drift.
RQs
for
nonlisted
and
listed
plant
species
are
presented
in
Table
21
below.
This
screening­
level
risk
assessment
for
nontarget
terrestrial
plants
suggests
potential
adverse
effects
on
seedling
emergence
from
runoff
and
spray
drift
to
adjacent
fields
and
potential
risk
of
adverse
effects
on
vegetative
vigor
from
spray
drift
alone.
RQs
are
below
the
LOC
except
for
nonlisted
dicots
based
on
use
on
turf
and
listed
dicots
based
on
use
in
grasses
grown
for
seed,
rice,
wild
rice,
peanut,
and
turf
use.
The
RQs
for
terrestrial
dicots
(
2.1­
2.5)
exceed
the
acute
LOC
of
1.0
for
terrestrial
plants
in
semi­
aquatic
areas
at
the
maximum
application
rate
for
turf.
The
RQs
for
listed
terrestrial
dicots
in
semi­
aquatic
areas
is
greater
than
the
LOC
for
use
on
turf
and
ornamentals
and
equal
to
the
LOC
for
use
on
grass
grown
for
seed,
rice,
wild
rice,
peanut,
and
turf
use.
For
monocots,
RQs
for
listed
species
exceed
the
LOC
for
spray
drift
from
propiconazole
use
on
turf
and
ornamentals.

Table
21.
Acute
Risk
Quotients
for
Terrestrial
and
Semi­
Aquatic
Plants
Exposed
to
Propiconazole
Scenario
RQs
for
Nonlisted
Species*
RQs
for
Listed
Species**

adjacent
to
treated
sites
in
semiaquatic
areas
adjacent
to
treated
sites
in
semiaquatic
areas
Use
Sites
Application
Method
Total
Exposure
Drift
Total
Drift
Total
Drift
Total
Drift
Nontarget
Dicots
Aerial
0.09
0.30
<
0/
31
0.30
0.04
0.20
1.01
0.20
Grasses
grown
for
seed,
Rice,
Wild
rice,
Peanut
Ground
0.04
0.06
0.26
0.06
0.12
0.04
0.84
0.04
Ground
0.03
0.46
2.1
0.46
0.95
0.32
6.68
0.32
Turf
and
ornamentals
 
ground
cover
Chemigation
0.7
2.28
2.47
2.28
2.23
1.59
7.95
1.59
Nontarget
Monocots
Aerial
<
0.01
0.036
<
0.06
<
0.04
0.01
0.61
0.04
0.61
Grasses
grown
for
seed,
Rice,
Wild
rice,
Peanut
Ground
<
0.005
0.007
<
0.03
0.007
0.005
0.12
0.03
0.12
Ground
<
0.04
0.06
<
0.25
0.06
0.036
0.96
0.25
0.96
Turf
and
ornamentals
 
ground
cover
Chemigation
<
0.08
0.28
<
0.3
0.28
0.083
4.81
0.30
4.81
*
RQs
for
nonlisted
species
are
based
on
EC25
;
**
RQs
for
listed
species
based
on
NOAEC
or
EC05.
Total
exposure
includes
runoff
and
drift
;
drift
is
from
spray
drift
alone.
RQs
for
total
exposure
based
on
seedling
emergence
endpoint;
RQs
for
spray
drift
are
based
on
vegetative
vigor
endpoint.
49
EPA's
screening­
level
model
Terr­
PLANT
assumes
that
a
certain
default
fraction
of
total
pesticide
applied
will
be
transported
to
adjacent
fields
via
surface
runoff
and
spray
drift.
For
propiconazole,
Terr­
PLANT
assumes
that
a
default
value
of
2%
propiconazole
applied
is
available
to
nontarget
plants
in
adjacent
fields.
Terr­
PLANT
calculates
exposure
based
only
on
a
single
application,
whereas
propiconazole
labels
allow
for
multiple
applications
of
propiconazole
(
i.
e.,
as
many
as
5
applications
to
stone
fruit).
Therefore,
Terr­
PLANT
may
potentially
underestimate
exposure
and
risk
to
plants.
However,
the
effects
of
multiple
applications
would
only
be
additive
if
the
affected
plants
could
not
recover
from
the
effects
of
successive
applications.
Furthermore,
there
is
uncertainty
in
the
likelihood
of
co­
exposure
of
spray
drift
and
runoff,
particularly
after
subsequent
applications.

To
address
uncertainties
in
the
Terr­
PLANT
model
and
further
characterize
the
risk
to
nontarget
terrestrial
plants
from
runoff,
EPA
compared
the
EEC
of
0.37
lb
ai/
A
from
a
single
application
of
1.78
lb
ai/
A
of
propiconazole
to
turf,
with
peak
runoff
EECs
simulated
by
PRIZM
over
30
years.
The
transport
of
propiconazole
from
the
peak
runoff
event
for
each
of
30
years
simulated
by
PRZM
ranged
from
0.009
lb
ai/
A
to
0.245
lb
ai/
A.
These
EECs,
which
reflect
4
applications
of
propiconazole
at
1.78
lb
ai/
A,
would
result
in
acute
RQs
ranging
from
0.05
to
1.4
if
used
in
the
risk
assessment.
Peak
storm
events
simulated
by
PRZM
would
result
in
RQs
at
or
above
the
LOC
of
1.0
in
6
of
the
30
years
simulated,
indicating
a
potential
risk
to
plants
adjacent
to
treated
fields
under
certain
conditions
if
the
maximum
rate
and
number
of
applications
are
applied.
Additional
details
of
this
assessment
may
be
found
in
the
July
18,
2006
document,
Terrestrial
Plant
Runoff
Risk
Assessment
for
Propiconazole
on
Turf
Using
PRZM.
Use
data
indicate
that
typical
rates
in
the
states
with
the
greatest
use
range
from
0.7
to
1.2
lbs
ai/
A.
Since
these
typical
rates
are
at
least
1/
3
less
than
the
maximum
rate,
the
25%
effect
on
seedling
emergence
represented
by
the
toxicity
endpoint
might
occur
even
less
frequently
than
suggested
by
the
PRZM
model
output.

EPA
also
used
the
AG­
DRIFT
model,
which
simulates
spray
drift
at
various
distances
from
the
site
of
application,
to
further
characterize
exposure
and
risk
to
nontarget
terrestrial
plants.
Pesticide
application
was
simulated
using
low­
boom
ground
spray
equipment
to
turf,
using
nozzles
which
produce
a
very
fine
to
fine
droplet
size
spectrum.
Using
the
90th
percentile
drift
data
generated
by
the
Spray
Drift
Task
Force
on
which
AgDrift
is
based,
the
model
predicted
the
distances
to
which
point
exposure
would
be
equivalent
to
the
EC25
values
for
various
crops
tested
in
the
propiconazole
vegetative
vigor
studies.
As
shown
in
Table
22
below,
an
AgDRIFT
simulation
for
the
four
most
sensitive
plants
in
a
vegetative
vigor
study
showed
that
spray
drift
RQs
from
ground
application
of
propiconazole
to
turf
would
exceed
the
LOC
to
distances
of
3
ft,
7
ft,
13
ft
and
43
ft,
assuming
10
mph
wind
perpendicular
to
the
spray
path.

Table
22.
Distance
Where
Spray
Drift
Deposition
Equals
EC25
Following
Spray
Application
to
Turf
Vegetative
Vigor
EC25
for
Sensitive
Test
Crops
Corn
0.968
lb
ai/
A
Onion
0.334
lb
ai/
A
Soybean
0.16
lb
ai/
A
Cabbage
0.039
lb
ai/
A
Distance
of
Spray
Drift
Deposition
with
Ag­
DRIFT
following
application
of
1.78
lb
ai/
A
to
Turf
3.3
ft
6.6
ft
13.1
ft
42.7
ft
The
results
indicate
that
exposure
that
would
result
in
risk
quotients
at
the
acute
LOC
would
be
expected
to
occur
within
50
feet
of
turf
treated
with
propiconazole.
An
additional
calculation
was
50
done
to
determine
the
distance
at
which
point
deposition
would
be
equivalent
to
the
lowest
NOAEC
in
the
vegetative
vigor
test
(
0.0185
lb
ai/
A
for
ryegrass).
The
calculated
distance
of
91.86
feet
suggests
that
listed
plants
more
than
100
feet
of
a
treated
field
may
be
at
less
risk.

The
next
highest
application
rate
for
propiconazole
after
turf
is
0.225
lb
ai/
acre
for
grasses
grown
for
seed,
pecan,
and
rice,
which
is
lower
than
the
EC25
for
all
but
soybeans
and
cabbage
in
the
vegetative
vigor
test.
However,
drift
from
aerial
application
of
0.225
lb
ai/
acre
could
result
in
point
deposition
equal
to
the
cabbage
vegetative
vigor
EC25
of
0.039
lb
ai/
A
up
to
a
distance
of
49
feet,
assuming
a
default
fine
to
medium
droplet
size
spectrum.
Drift
from
aerial
application
of
0.225
lb
ai/
acre
could
result
in
point
deposition
equal
to
the
ryegrass
vegetative
vigor
NOAEC
of
0.0185
lb
ai/
A
up
to
a
distance
of
118
feet,
assuming
the
same
fine
to
medium
droplet
size
spectrum.

b.
Aquatic
Organisms
Freshwater
and
Estuarine/
Marine
Fish
and
Invertebrates.
To
assess
potential
risks
to
aquatic
animals,
the
Agency
considers
predicted
estimated
environmental
concentrations
(
EECs)
in
surface
water
using
the
Tier
II
model
PRZM/
EXAMS.
Unlike
the
drinking
water
assessment
described
in
the
human
health
risk
assessment
section
of
this
document,
the
exposure
values
used
in
the
ecological
risk
assessment
consider
pesticide
transport
as
a
result
of
runoff,
erosion,
off­
target
spray
drift,
and
environmental
fate
of
pesticides
in
surface
water
but
do
not
include
the
Index
Reservoir
(
IR)
and
Percent
Cropped
Area
(
PCA)
factor
refinements.
These
factors
represent
a
drinking
water
reservoir,
not
the
variety
of
aquatic
habitats
relevant
to
a
risk
assessment
for
aquatic
animals,
such
as
ponds
adjacent
to
treated
fields.
Therefore,
the
EEC
values
used
to
assess
exposure
and
risk
to
aquatic
animals
are
not
the
same
as
those
used
to
assess
exposure
and
risk
to
humans
from
pesticides
in
drinking
water.

The
EECs
of
propiconazole
used
in
the
ecological
risk
assessment
are
summarized
in
Table
23
below.
The
highest
EEC
is
86.5
and
is
associated
with
the
use
of
propiconazole
on
rice.
The
rice
scenario
represents
the
most
conservative
aquatic
exposure
estimate
of
the
potential
exposure
scenarios
for
propiconazole;
the
rice
EEC
value
of
86.5
ppb
represents
paddy
discharge
water
with
consideration
of
adsorption,
degradation,
and
dilution
but
does
not
account
for
degradation
after
discharge.
The
turf
scenario
represents
the
next
highest
EECs;
this
scenario
assumes
use
at
the
maximum
rate,
maximum
number
of
applications,
and
minimum
time
interval
between
applications.

Table
23.
Estimated
Environmental
Concentrations
of
Propiconazole
in
Surface
Water
Use
Scenario
and
State
Peak
(
µ
g/
L)
96­
hour
average
(
µ
g/
L)
21­
day
average
(
µ
g/
L)
60­
day
average
(
µ
g/
L)
90­
day
average
(
µ
g/
L)

Wheat
ND
3.70
3.64
3.41
3.12
3.08
Grass
Seed
OR
5.69
5.63
5.41
5.06
4.95
Rice
86.5
71.1
34.2
17.8
11.9
Pecans
GA
12.15
11.93
11.21
10.15
9.49
51
Table
23.
Estimated
Environmental
Concentrations
of
Propiconazole
in
Surface
Water
Use
Scenario
and
State
Peak
(
µ
g/
L)
96­
hour
average
(
µ
g/
L)
21­
day
average
(
µ
g/
L)
60­
day
average
(
µ
g/
L)
90­
day
average
(
µ
g/
L)

Peaches
GA
3.35
3.28
3.01
2.55
2.35
Sweet
Corn
FL
13.28
13.00
12.32
10.70
9.77
Sweet
Corn
OR
4.49
4.46
4.30
4.09
4.06
Dry
Beans
MI
6.49
6.41
6.17
5.83
5.64
Peanuts
NC
7.00
6.89
6.49
6.16
5.75
Barley
(
based
on
ND
Wheat)
1.92
1.89
1.79
1.66
1.61
Celery
(
based
on
FL
Carrots)
9.83
9.68
9.12
7.07
5.97
Turf
PA
40.35
39.59
37.28
34.83
33.98
Turf
FL
34.77
34.09
31.14
27.93
27.04
EPA
determines
the
potential
effects
a
pesticide
can
produce
in
an
aquatic
organism
by
reviewing
guideline
toxicity
studies
that
describe
acute
and
chronic
effects
for
various
aquatic
animals.
Table
24
below
summarizes
the
toxicity
effects
and
reference
values
used
to
assess
risk
of
propiconazole
to
aquatic
organisms.
No
acceptable
guideline
chronic
toxicity
studies
were
available
for
propiconazole
in
estuarine/
marine
fish;
however,
the
LC50
for
spot
was
2244
ug/
L,
compared
with
an
LC50
of
850
ug/
L
for
rainbow
trout.

Table
24.
Propiconazole
Toxicity
Reference
Values
for
Aquatic
Organisms.

Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
ppb)
Toxicity
Category
or
Effect
Acute
rainbow
trout
96
hours
LC50
=
850
Highly
toxic
Freshwater
Fish
Chronic
Fathead
minnow
Early
life
stage
NOAEC
=
95
Mortality,
length,
weight
Acute
Daphnia
magna
96
hours
LC50
=
4800
Slightly
toxic
Freshwater
Invertebrate
Chronic
Daphnia
magna
Study
not
suitable
for
use
in
risk
assessment
Acute
Spot
96
hours
LC50
=
2244
Moderately
toxic
Estuarine/
Marine
Fish
Chronic
No
acceptable
guideline
studies
were
available
Acute
Mysid
shrimp
96
hours
LC50
=
510
Highly
toxic
Estuarine/
Marine
Invertebrates
Chronic
Mysid
shrimp
Life
cycle
NOAEC
=
205
Mortality
and
number
of
offspring
52
Table
25
presents
acute
and
chronic
RQs
for
both
estuarine/
marine
and
freshwater
fish
and
invertebrates.
Based
on
the
maximum
1­
in­
10
year
peak
surface
water
concentrations
and
the
most
sensitive
96­
hour
LC50
values
for
fish
and
aquatic
invertebrates,
all
propiconazole
RQs
are
less
than
the
Agency's
LOC
for
acute
risk
(
0.5).
However,
the
freshwater
fish
RQ
is
equal
to
the
acute
listed
species
LOC
of
0.05
based
on
EECs
in
surface
water
from
turf
use
in
Pennsylvania,
but
does
not
exceed
based
on
EECs
in
surface
water
from
turf
use
in
Florida.
In
addition,
the
estuarine/
marine
fish
acute
RQ
exceeds
the
listed
species
LOC
based
on
rice
use.
And
finally,
the
estuarine/
marine
invertebrate
acute
RQs
exceed
the
acute
listed
species
LOC
(
0.05)
for
both
the
turf
and
rice
uses.
No
LOCs
were
exceeded
for
any
other
crop
to
which
propiconazole
is
applied;
RQs
for
the
other
crops
are
significantly
less
than
the
turf
RQ
and
the
LOC
and
therefore
were
not
included
in
Table
25.

Chronic
RQs
that
for
freshwater
fish
and
for
estuarine/
marine
invertebrates
do
not
exceed
the
Agency's
chronic
LOC
of
1
based
on
average
surface
water
concentrations
of
propiconazole
resulting
from
both
the
turf
and
rice
scenarios
and
available
toxicity
data.
These
RQs
are
presented
in
Table
25
below.
As
previously
mentioned,
the
Agency
does
not
have
adequate
chronic
toxicity
data
to
assess
chronic
risks
from
propiconazole
uses
to
estuarine/
marine
fish
or
freshwater
invertebrates.
There
is
a
data
gap
for
these
studies;
however,
the
existing
data
may
be
upgraded.

Table
25.
Summary
of
Acute
and
Chronic
Risk
Quotients
for
Aquatic
Organisms
Exposed
to
Propiconazole.

Freshwater
RQs
Estuarine/
Marine
RQs
Crop
Scenario
EECs
(
ppb)
Fish
Invertebrates
Fish
Invertebrates
Acute
Risks
Turf
40.35
(
peak)
0.05
0.008
0.02
0.08
Rice
86.5
0.1
0.02
0.04
0.17
Chronic
Risks
Turf
34.8
(
fish
 
60
day
average)
37.3
(
invertebrate
 
21
day
average)
0.36
No
data
No
data
0.18
Rice
17.81
(
fish
 
60
day
average)
34.24
(
invertebrates
 
60
day
average)
0.19
No
data
No
data
0.17
Aquatic
Plants.
EPA
determines
the
potential
effects
a
pesticide
can
produce
in
aquatic
plants
by
reviewing
guideline
toxicity
studies
that
describe
acute
and
chronic
effects
for
various
aquatic
plants.
Table
25
summarizes
the
toxicity
data
used
to
assess
risk
of
propiconazole
to
aquatic
plants.
These
studies
showed
that
the
marine
diatom,
Skeletonema
costatum,
is
the
most
senstive
aquatic
plants
species
of
those
tested
with
a
NOAEC
of
18
ug/
L.
The
NOAEC
is
used
to
calculate
acute
listed
species
RQs
and
the
EC50
is
used
to
calculate
acute
RQs
for
aquatic
plants.
53
Table
26.
Acute
Toxicity
of
Propiconazole
to
Aquatic
Plants
Species
EC50
(
ug
ai/
L)
NOAEC/
EC05
(
ug
ai/
L)
Effect
Vascular
Plants
Duckweed
(
Lemna
gibba)
4828
<
2540
Frond
count
Non­
Vascular
Plants
Freshwater
diatom
(
Navicula
pelliculosa)
93
51
Dry
cell
weight
Blue
green
algae
(
Skeletonema
costatum)
21
<
18
Dry
cell
weight
As
shown
in
Table
27
below,
the
use
of
propiconazole
on
rice
and
turf
may
present
risk
to
non­
vascular
estuarine/
marine
plants;
both
the
acute
and
listed
species
RQs
exceed
the
LOC
of
1.
In
addition,
the
use
of
propiconazole
on
rice
may
present
an
acute
risk
to
listed
freshwater
non­
vascular
plants;
the
listed
species
RQs
exceed
the
LOC
of
1.

The
RQs
for
freshwater
vascular
plants
based
on
both
turf
and
rice
use
and
the
RQs
for
freshwater
non­
vascular
plants
based
on
turf
use
do
not
exceed
the
LOC.
In
addition,
RQs
based
on
EECs
for
other
crops
do
not
exceed
the
Agency's
LOC
and
are
therefore
not
presented
in
Table
27
below.
As
previously
mentioned,
the
highest
modeled
EECs
are
for
the
use
of
propiconazole
on
rice.

Table
27.
Risk
Quotients
for
Aquatic
Plants
Exposed
to
Propiconazole.

Freshwater
Vascular
Plants
Freshwater
Non­
Vascular
Plants
Estuarine/
Marine
Non­
Vascular
Plants
Crop
EECs
(
ppb)
Listed
Acute
Listed
Acute
Listed
Acute
Turf
 
Florida
34.88
Not
calculated,
less
than
PA
turf
and
not
of
concern
>
1.93
1.66
Turf
 
Pennsylvania
40.35
>
0.016
0.008
0.79
0.43
>
2.24
1.92
Rice
86.5
>
0.03
0.02
1.7
0.93
>
4.81
4.12
RQs
in
bold
are
above
EPA's
level
of
concern
(
LOC).

3.
Endangered
Species
The
screening­
level
risk
assessment
for
propiconazole
indicates
a
potential
for
adverse
effects
on
listed
species
as
noted
below,
should
exposure
actually
occur
at
modeled
levels:

Terrestrial
organisms
 
Mammals
o
Acute
RQs
for
turf
and
ornamentals
exceed
LOCs
for
small
mammals
feeding
on
short
grass,
tall
grass,
broadleaf
forage
and
small
insects;
54
o
Chronic
RQs
for
turf
and
ornamentals
exceed
LOC
for
all
mammals
feeding
on
short
grass,
tall
grass,
broadleaf
forage
and
small
insects;
 
Birds
o
Acute
RQs
for
turf
and
ornamentals
exceed
LOCs
for
all
birds
feeding
on
short
grass
and
tall
grass
and
for
smaller
birds
feeding
on
broadleaf
forage
and
small
insects;
o
Chronic
RQs
for
turf
and
ornamentals
barely
exceed
the
LOC.
Although
these
RQs
were
based
on
a
study
that
showed
no
effects
at
the
highest
dose
tested;
EPA
cannot
preclude
potential
adverse
effects
to
listed
species;
 
Plants
o
Acute
RQs
for
turf
and
ornamentals
exceed
LOCs
for
listed
terrestrial
plants
(
monocots
and
dicots)
adjacent
to
treated
sites
and
in
semiaquatic
areas;
o
Acute
RQs
for
grasses
grown
for
seed,
rice,
and
peanuts
are
equal
to
the
LOC
for
dicots
in
semi­
aquatic
areas.

Aquatic
Organisms
 
Freshwater
o
Acute
fish
RQ
for
Pennsylvania
turf
is
equal
to
LOC
for
listed
species;
Florida
turf
scenario
does
not
exceed
LOC;
o
Acute
fish
RQ
for
rice
exceeds
LOC
for
listed
species;
o
Because
no
data
are
available
to
evaluate
chronic
risks
to
freshwater
invertebrates,
EPA
has
a
potential
concern
for
listed
species;
 
Estuarine/
Marine
o
Acute
invertebrate
RQs
for
turf
and
rice
exceed
LOC
for
listed
species;
o
Because
no
data
are
available
to
evaluate
chronic
risks
to
estuarine/
marine
fish,
EPA
has
a
potential
concern
for
listed
species;
 
Plants
o
Acute
RQs
for
turf
exceed
LOCs
for
listed
estuarine/
marine
nonvascular
plants;
and
o
Acute
RQs
for
rice
exceed
LOCs
for
listed
freshwater
and
estuarine/
marine
nonvascular
plants.

These
conclusions
are
based
solely
on
EPA's
screening­
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act
for
any
listed
species.

4.
Ecological
Incidents
EPA
completed
a
review
of
the
Ecological
Incident
Information
System
(
EIIS)
database
for
ecological
incidents
involving
propiconazole
in
November
2005.
This
database
reported
a
total
of
six
incidents
associated
with
the
use
of
propiconazole:
four
involving
damage
to
terrestrial
plants,
and
the
remaining
two
involving
damage
to
fish
and
shrimp.
However,
because
no
environmental
sampling
was
conducted
to
evaluate
pesticide
residues,
there
is
considerable
uncertainty
about
the
credibility
of
these
incidents.
Therefore,
all
of
the
propiconazole
incidents
were
classified
as
having
a
"
possible"
rather
than
a
"
probable"
or
55
"
highly
probable:
association
with
propiconazole.
No
detailed
information
was
available
for
the
terrestrial
plant
incidents;
therefore,
the
extent
of
damage
and
recovery
is
not
known.
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
A.
Determination
of
Reregistration
Eligibility
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
propiconazole
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
propiconazole.

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
propiconazole.
Based
on
a
review
of
these
data
and
on
public
comments
on
the
Agency's
assessments
for
the
active
ingredient
propiconazole,
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
the
active
ingredient
propiconazole
are
eligible
for
reregistration
provided
that:
(
i)
required
product­
specific
data
are
submitted,
(
ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
(
ii)
label
amendments
are
made
to
reflect
these
measures.
Necessary
label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
propiconazole
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
propiconazole,
and
lists
the
submitted
guideline
studies
that
the
Agency
found
acceptable.
Data
gaps
are
identified
as
generic
data
requirements
that
have
not
been
satisfied
with
acceptable
data.

Based
on
its
evaluation
of
propiconazole,
the
Agency
has
determined
that
propiconazole
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
propiconazole.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
propiconazole
will
be
adequately
mitigated
for
the
purposes
of
this
determination
under
FIFRA.
Once
an
Endangered
Species
assessment
is
completed,
further
changes
to
these
registrations
may
be
necessary
as
explained
in
Section
III.
B.
3.
of
this
document.

B.
Public
Comments
and
Responses
Through
the
Agency's
public
participation
process,
EPA
worked
with
stakeholders
and
the
public
to
reach
the
regulatory
decisions
for
propiconazole.
EPA
released
its
preliminary
risk
assessments
for
propiconazole
for
public
comment
on
February
15,
2006,
for
a
60­
day
public
comment
period
(
Phase
3
of
the
public
participation
process).
During
the
public
56
comment
period
on
the
risk
assessments,
which
closed
on
April
17,
2006,
the
Agency
received
comments
from
the
American
Mushroom
Institute,
the
University
of
Georgia,
the
University
of
Hawaii,
the
US
Triazole
Task
Force,
and
the
major
technical
registrants,
Janssen
Pharmaceutica
Inc.
and
Syngenta
Crop
Protection.
These
comments
in
their
entirety,
responses
to
the
comments,
as
well
as
the
preliminary
and
revised
risk
assessments,
are
available
in
the
public
docket
(
EPA­
HQ­
OPP­
2005­
0497)
at
the
address
given
above
and
in
the
EPA's
electronic
docket
at
http://
www.
regulations.
gov.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
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
propiconazole
are
within
acceptable
levels.
In
other
words,
EPA
has
concluded
that
the
tolerances
for
propiconazole
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
propiconazole
from
all
possible
sources.

b.
Determination
of
Safety
to
U.
S.
Population
The
Agency
has
determined
that
the
established
tolerances
for
propiconazole,
with
amendments
and
changes
as
specified
in
this
document,
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
propiconazole.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
propiconazole
and
its
free
triazole
degradates.

As
discussed
in
Section
III,
the
aggregate
risks
from
propiconazole
from
food,
drinking
water,
and
residential
exposure
are
not
of
concern.
Furthermore,
aggregate
risks
from
the
free
triazoles
(
1,2,4­
triazole,
traizole
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
propiconazole,
with
amendments
and
changes
as
specified
in
this
document,
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
57
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
propiconazole
residues
in
this
population
subgroup.

In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
exposure
to
residues
of
propiconazole,
the
Agency
considered
the
completeness
of
the
hazard
database
for
developmental
and
reproductive
effects,
the
nature
of
the
effects
observed,
and
other
information.
On
the
basis
of
this
information,
the
FQPA
SF
has
been
removed
(
i.
e.,
reduced
to
1X)
for
propiconazole.
In
addition,
the
Agency
determined
whether
infants
and
children
show
potential
susceptibility
from
exposure
to
residues
of
the
free
triazole
degradates
1,2,4­
triazole,
triazole
acetic
acid,
and
triazole
alanine.
EPA
retained
a
10X
FQPA
SF
for
1,2,4­
triazole
based
on
nervous
system
effects
and
database
uncertainties,
including
a
data
gap
for
acute
and
developmental
neurotoxicity
studies.
(
A
developmental
neurotoxicity
study
is
required
for
1,2,4­
triazole.)
The
Agency
also
retained
a
10X
FQPA
SF
for
the
triazole
conjugates
to
address
concerns
for
increased
susceptibility
seen
in
the
available
rat
developmental
toxicity
and
two­
generation
reproduction
and
to
address
uncertainties
associated
with
an
incomplete
database.
There
are
data
gaps
for
rabbit
developmental
toxicity
studies
with
triazole
alanine
and
triazole
acetic
acid,
a
chronic
rat
study
with
triazole
alanine,
and
a
combined
90­
day/
subchronic
neurotoxicity
rat
study
for
triazole
acetic
acid.
The
rationale
for
the
decisions
on
the
FQPA
SF
for
both
propiconazole
and
the
free
triazoles
can
be
found
in
Section
III
and
in
the
documents,
Propiconazole
 
3X
database
uncertainty
factor
used
in
risk
assessment,
dated
December
29,
2005
and
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,
dated
February
7,
2006,
both
of
which
may
be
found
in
the
docket
EPA­
HQ­
OPP­
2005­
0497.

2.
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
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
that
EPA
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).
In
the
available
toxicity
studies
on
propiconazole,
there
was
no
evidence
of
estrogen,
androgen,
and/
or
thyroid­
mediated
toxicity.
Although
the
available
toxicity
data
for
1,2,4­
triazole
indicate
potential
estrogen,
androgen,
and
thyroid
effects,
the
Agency
believes
that
the
current
risk
assessment
is
protective
of
these
effects.
When
additional
appropriate
screening
and/
or
testing
protocols
being
considered
by
the
Agency's
EDSP
have
been
developed,
propiconazole
may
be
subjected
to
further
screening
and/
or
testing
to
better
58
characterize
effects
related
to
endocrine
disruption.

3.
Cumulative
Risks
Section
408(
b)(
2)(
D)(
v)
of
FIFRA
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
propiconazole
does
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.
Propiconazole
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.

D.
Tolerance
Reassessment
Summary
1.
Tolerance
Definition
EPA
has
established
tolerances
for
propiconazole
in/
on
animal
and
plant
commodities
under
40
CFR
§
180.434.
These
tolerances
are
currently
expressed
in
terms
of
the
combined
residues
of
propiconazole
(
1­[[
2­(
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole)
and
its
metabolites
determined
as
residues
converted
to
2,4­
dichlorobenzoic
acid
(
DCBA)
and
expressed
as
parent
compound.
As
part
of
the
tolerance
reassessment
for
propiconazole,
the
tolerance
expression
should
be
revised
to
parent
propiconazole
per
se,
(
1­
[[
2­(
2,4­
dichlorophenyl)­
4propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole).
Because
the
analytical
method
is
a
common
moiety
method
detecting
all
residues
(
parent
and
metabolites)
that
are
converted
to
DCBA,
the
field
trial
studies
reported
total
residues,
and
tolerance
levels
based
on
these
data
may
be
overestimated.
(
Future
field
trial
studies
should
use
a
method
that
analyzes
for
both
parent
and
metabolites.)
Although
the
free
triazoles
are
not
included
in
tolerance
expression;
they
are
considered
in
the
risk
assessment
supporting
tolerance
reassessment.
A
summary
of
the
residues
considered
in
the
risk
assessment
and
in
the
tolerance
expression
for
propiconazole
is
given
in
Table
28.

Table
28.
Summary
of
Propiconazole
Residues
of
Concern
for
Tolerance
Expression
and
Risk
Assessment
For
Risk
Assessment1
Matrix
Propiconazole
Free
Triazoles
For
Tolerance
Expression
Plants,
rotational
crops,
livestock
Parent
plus
all
metabolites
convertible
to
2,4­
DCBA
1,2,4­
triazole,
triazole
alanine,
triazole
acetic
acid
Parent
only
Water
Parent
only
1,2,4­
triazole
Not
applicable
59
Table
28.
Summary
of
Propiconazole
Residues
of
Concern
for
Tolerance
Expression
and
Risk
Assessment
For
Risk
Assessment1
Matrix
Propiconazole
Free
Triazoles
For
Tolerance
Expression
1Three
risk
assessments
were
conducted,
one
for
propiconazole
parent,
one
for
1,24,­
triazole,
and
a
combined
assessment
for
the
triazole
conjugates,
triazole
alanine
and
triazole
acetic
acid.

2.
Tolerance
Reassessment
Summary
The
reassessments
of
tolerances
for
some
commodities
are
contingent
upon
the
implementation
of
requested
label
revision(
s).
The
propiconazole
tolerance
reassessment
is
summarized
in
Table
29.

Table
29.
Tolerance
Reassessment
Summary
for
Propiconazole
Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Tolerances
Established
Under
40
CFR
§
180.434(
a)

for
Raw
Agricultural
Commodities
(
RACs)

Banana
0.2
0.2
[
Banana]

Barley,
grain
0.1
0.3
Available
residue
data
for
wheat
support
raising
barley
tolerance.

Barley,
straw
1.5
15.0
Available
residue
data
for
wheat
support
raising
the
barley
tolerance.

Cattle,
fat
0.1
0.1
Maximum
theoretical
dietary
burden
(
MTDB)
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Cattle,
kidney
2.0
2.0
MTDB
of
1.01
ppm
supports
maintaining
tolerance
at
current
level.

Cattle,
liver
2.0
2.0
MTDB
of
1.33
ppm
supports
maintaining
tolerance
at
current
level.

Cattle,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Cattle,
meat
0.1
0.1
MTDB
of
0.04
ppm
supports
maintaining
tolerance
at
current
level.

Celery
5.0
5.0
Available
residue
data
support
maintaining
tolerance
at
current
level.

Corn,
field,
grain
0.1
0.1
Tolerance
expires
on
November
30,
2008.

Corn,
field,
stover
12
12
Tolerance
expires
on
November
30,
2008.

Corn,
field,
forage
12
12
Tolerance
expires
on
November
30,
2008.
60
Table
29.
Tolerance
Reassessment
Summary
for
Propiconazole
Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Corn,
sweet,
kernel
plus
cob
with
husks
removed
0.1
0.1
Tolerance
expires
on
November
30,
2008.

Fruit,
stone,
group
12
1.0
1.0
Available
residue
data
support
maintaining
tolerance
at
current
level.

Goat,
fat
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Goat,
kidney
2.0
2.0
MTDB
of
1.01
ppm
supports
maintaining
tolerance
at
current
level.

Goat,
liver
2.0
2.0
MTDB
of
1.33
ppm
supports
maintaining
tolerance
at
current
level.

Goat,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Goat,
meat
0.1
0.1
MTDB
of
0.04
ppm
supports
maintaining
tolerance
at
current
level.

Grass,
forage
0.5
0.5
Available
residue
data
support
maintaining
tolerance
at
current
level.

Grass,
hay
40
40
Available
residue
data
support
maintaining
tolerance
at
current
level.

Grass,
straw
40
40
Available
residue
data
support
maintaining
tolerance
at
current
level.

Hog,
fat
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Hog,
kidney
2.0
2.0
MTDB
of
1.01
ppm
supports
maintaining
tolerance
at
current
level.

Hog,
liver
2.0
2.0
MTDB
of
1.33
ppm
supports
maintaining
tolerance
at
current
level.

Hog,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Hog,
meat
0.1
0.1
MTDB
of
0.04
ppm
supports
maintaining
tolerance
at
current
level.

Horse,
fat
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Horse,
kidney
2.0
2.0
MTDB
of
1.01
ppm
supports
maintaining
tolerance
at
current
level.

Horse,
liver
2.0
2.0
MTDB
of
1.33
ppm
supports
maintaining
tolerance
at
current
level.

Horse,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Horse,
meat
0.1
0.1
MTDB
of
0.04
ppm
supports
maintaining
tolerance
at
current
level.
61
Table
29.
Tolerance
Reassessment
Summary
for
Propiconazole
Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Milk
0.05
0.05
MTDB
of
0.03
ppm
supports
maintaining
tolerance
at
current
level.

Mushroom
0.1
0.1
Pending
approval
of
a
label
use
on
mushrooms
and
submission
of
directions
for
use
(
OPPTS
860.1200).
Use
supported
by
IR­
4.

Oat,
forage
10.0
10.0
[
Oat,
forage]

Oat,
grain
0.1
0.1
[
Oat,
grain]

Oat,
hay
30.0
2.0
Available
data
for
wheat
support
lowering
tolerance
for
oat
hay.

Oat,
straw
1.0
1.0
Available
residue
data
support
maintaining
tolerance
at
current
level.

Peanut
0.2
0.2
Tolerance
expires
November
30,
2008.

Peanut,
hay
20.0
20.0
Tolerance
expires
November
30,
2008.

Pecans
0.1
Reassign
Tolerance
should
be
reassigned
concomitant
with
establishing
a
tolerance
of
0.1
ppm
for
Nut,
tree,
Group
14
Pineapple
0.1
0.1
Tolerance
expires
November
30,
2008.
Pineapple
processing
study
required.

Pineapple,
fodder
0.1
Revoke
No
longer
considered
a
significant
livestock
feed
item,
revoke.
Tolerance
expires
November
30,
2008.

Plum,
prune,
fresh
1.0
Revoke
Tolerance
should
be
revoked
because
a
crop
group
tolerance
has
been
established
for
Fruit,
stone,
Group
12.

Rice,
grain
0.1
0.3
Available
residue
data
support
raising
tolerance.

Rice,
straw
3.0
3.0
Available
residue
data
support
maintaining
tolerance
at
current
level.

Rye,
grain
0.1
0.3
Available
residue
data
support
raising
tolerance.

Rye,
straw
1.5
15.0
Available
residue
data
for
wheat
straw
support
raising
the
tolerance.

Sheep,
fat
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level.

Sheep,
kidney
2.0
2.0
MTDB
of
1.01
ppm
supports
maintaining
tolerance
at
current
level.
62
Table
29.
Tolerance
Reassessment
Summary
for
Propiconazole
Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Sheep,
liver
2.0
2.0
MTDB
of
1.33
ppm
supports
maintaining
tolerance
at
current
level.

Sheep,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
MTDB
of
0.08
ppm
supports
maintaining
tolerance
at
current
level
Sheep,
meat
0.1
0.1
MTDB
of
0.04
ppm
supports
maintaining
tolerance
at
current
level.

Wheat,
grain
0.1
0.30
Available
residue
data
support
raising
tolerance.

Wheat,
straw
1.5
15.0
Available
residue
data
support
raising
tolerance.

Tolerances
To
Be
Proposed
Under
40
CFR
§
180.434(
a)

for
Raw
Agricultural
Commodities
Grain,
aspirated
grain
fractions
20
(
sorghum)
5.0
Available
residue
data
support
lowering
tolerance.
Time­
limited
tolerance
for
sorghum
Section
18
registration
expires
June
30,
2008.

Barley,
hay
None
established
2.0
Translate
from
wheat
hay
Corn,
pop,
grain
None
established
0.1
Translate
from
field
corn
Corn,
pop,
stover
None
established
12
Translate
from
field
corn
Corn,
sweet,
forage
None
established
12
Translate
from
field
corn
Corn,
sweet,
stover
None
established
12
Translate
from
field
corn
Nut,
tree,
group
14
None
established
0.1
[
Nut,
tree.
Group
14]

Rice,
bran
None
established
1.0
Rice
processing
study
shows
2.9x
concentration
factor
for
rice
bran.

Rice,
hulls
None
established
1.2
Rice
processing
study
shows
3.8x
processing
factor
for
rice
hulls.

Rye,
forage
None
established
2.0
Available
residue
data
support
tolerance.

Wheat,
forage
None
established
2.0
Available
residue
data
support
tolerance.

Wheat,
hay
None
established
2.0
Available
residue
data
support
tolerance.

Wheat,
bran
None
established
1.0
Available
residue
data
support
tolerance.

Time­
limited
Tolerances
Established
Under
40
CFR
§
180.434(
b)

for
FIFRA
§
18
Emergency
Exemptions
Blueberry
1.0
N/
A
T
olerance
expires
December
31,
2007.

Cranberry
1.0
N/
A
T
olerance
expires
December
31,
2007.
63
Table
29.
Tolerance
Reassessment
Summary
for
Propiconazole
Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Dry
bean
0.5
N/
A
Tolerance
expired
December
31,
2005.
[
Bean,
dry]

Dry
bean
forage
8.0
N/
A
Tolerance
expired
December
31,
2005.
[
Bean,
dry,
forage]

Dry
bean
hay
8.0
N/
A
Tolerance
expired
December
31,
2005.
[
Bean,
dry,
hay]

Grain,
aspirated
grain
fractions
20
(
sorghum)
5.0
Available
residue
data
support
lowering
tolerance.
Tolerance
expires
June
30,
2008.

Sorghum,
grain,
grain
0.2
N/
A
Tolerance
expires
June
30,
2008.

Sorghum,
grain,
stover
1.5
N/
A
Tolerance
expires
June
30,
2008.

Soybean
2.0
N/
A
Tolerance
expires
December
31,
2009.

Soybean,
forage
10.0
27N/
A
Tolerance
expires
December
31,
2009.

Soybean,
hay
25.0
N/
A
Tolerance
expires
December
31,
2009.

Tolerances
Established
Under
40
CFR
§
180.434(
c)
for
Regional
Registrations
Sunflower
None
established
TBD
T
o
be
determined
pending
submission
of
field
trial
data.

Mint,
tops
(
leaves
and
stems)
0.3
0.3
Regional
registration
for
use
west
of
the
Cascade
Mountains
only.
[
Peppermint,
tops]
[
Spearmint,
tops]

Wild
rice
0.5
0.5
Regional
registration
for
use
only
in
Minnesota.
[
Rice,
wild]

a.
Tolerances
for
Raw
Agricultural
Commodities
(
RACs)
Established
Under
40
CFR
§
180.434(
a)

The
Agency
has
recently
updated
the
list
of
raw
agricultural
and
processed
commodities
and
feedstuffs
derived
from
crops
(
Table
1,
OPPTS
GLN
860.1000).
As
a
result
of
these
changes,
tolerances
must
be
established
for
raw
agricultural
commodities
recently
added
to
the
list
in
Table
1,
OPPTS
GLN
860.1000
and
certain
tolerances
for
crops
in
a
crop
group
should
be
reassigned.
The
established
tolerance
for
plums
should
be
revoked
because
a
stone
fruit
group
tolerance
has
been
established.
The
established
tolerance
for
pineapple
fodder
should
be
revoked
because
this
commodity
is
no
longer
considered
a
significant
livestock
feed
item.
The
established
tolerances
for
RACs
listed
under
40
CFR
§
180.434(
a)
are
reassessed
at
the
same
levels
except
those
listed
for
barley,
rice,
rye,
and
wheat;
higher
tolerances
are
required
for
these
crops
to
reflect
the
results
of
recent
field
trials.
The
established
tolerances
for
cattle,
goat,
hog,
horse,
and
sheep
commodities
listed
under
40
CFR
§
180.434(
a)
are
reassessed
at
the
same
levels
as
well,
because
EPA
is
unable
to
separate
the
parent
residues
from
the
metabolites,
and
because
the
pending
petitions
for
new
uses
are
likely
to
result
in
an
increased
dietary
burden.
64
b.
Tolerances
for
RACs
to
be
Proposed
under
40
CFR
§
180.434(
a)

Because
of
changes
to
Table
1
in
OPPTS
GDLN
860.1000,
new
tolerances
must
be
proposed
for
barley
hay,
rye
forage,
and
wheat
forage
and
hay.
The
required
data
for
wheat
hay
and
forage
will
be
translated
to
barley
hay
and
rye
forage.
Because
the
tolerance
level
for
oat
hay
was
not
determined
from
residue
data
but
was
calculated
from
the
oat
forage
level
using
a
3x
dry­
down
factor,
the
required
data
for
wheat
hay
should
be
translated
to
oat
hay
to
provide
a
more
realistic
level
for
this
tolerance.
Based
on
the
cited
field
trials
with
Stratego
 
Twin­
Pak
 
and
Stratego
 
,
the
Agency
proposes
new
tolerances
on
wheat
hay
and
forage
at
2.0
ppm.
The
Agency
now
recommends
that
wheat
hay
data
be
translated
to
oats
to
establish
a
more
appropriate
level
for
the
oat
hay
tolerance
at
2.0
ppm.

The
Agency
is
translating
the
wheat
grain,
wheat
straw,
wheat
hay,
and
wheat
forage
data
to
barley
and
rye
grain,
straw,
hay
and
forage.
Therefore,
the
reassessed
tolerances
for
barley
grain
and
rye
grain
should
be
0.3
ppm,
for
barley
and
rye
straw
should
be
15.0
ppm.
New
tolerances
for
barley
hay
and
rye
forage
should
be
established
at
2.0
ppm.
Data
from
a
wheat
processing
study
indicate
the
need
for
1.0
ppm
tolerance
for
wheat
bran
and
a
5.0
ppm
tolerance
for
aspirated
grain
fractions.
The
available
rice
processing
data
indicate
that
residues
of
propiconazole
may
concentrate
in
rice
bran
at
2.9x,
in
rice
hulls
at
3.8x,
and
in
polished
rice
at
0.12x.
Based
on
a
highest
average
field
trial
(
HAFT)
residue
value
of
0.28
ppm,
new
tolerances
of
1.0
and
1.2
ppm
must
be
proposed
for
rice
bran
and
hull,
respectively.

The
commodity
definitions
for
the
corn
RAC
tolerances
are
currently
expressed
as
corn
per
se.
When
the
definition
is
revised
to
"
corn,
field,"
tolerances
for
popcorn
grain
and
stover,
expressed
in
terms
of
"
corn,
pop,"
will
need
to
be
established
at
levels
of
0.1
ppm
and
12
ppm,
respectively.
In
addition,
tolerances
for
"
corn,
sweet,
forage"
and
"
corn,
sweet,
stover"
will
need
to
be
established
at
12
ppm.
Processing
data
are
required
for
pineapple
juice.

c.
Time­
Limited
Tolerances
Established
Under
40
CFR
§
180.434(
b)

Time­
limited
tolerances
have
been
established
for
blueberry;
cranberry;
grain,
aspirated
fractions;
sorghum
grain,
grain;
sorghum
grain,
stover;
soybean;
soybean
forage;
and
soybean
hay
to
support
FIFRA
Section
18
registrations
for
these
commodities.
These
timelimited
tolerances
have
expiration
dates
ranging
from
December
31,
2007
to
December
31,
2009.
Where
appropriate,
FIFRA
Section
3
tolerances
will
be
established
for
these
crops;
e.
g.,
permanent
tolerance
for
aspirated
grain
fractions.
Although
time­
limited
tolerances
were
established
in
the
past
for
dry
bean,
dry
bean
forage,
and
dry
bean
hay,
these
tolerances
expired
on
December
31,
2005.

d.
Tolerances
with
Regional
Registrations
Established
Under
40
CFR
§
180.434(
c)

Tolerances
with
regional
registrations
have
been
established
for
the
following
RACs
as
defined:
mint,
tops
(
leaves
and
stems)
and
wild
rice.
The
tolerance
for
mint
is
restricted
to
use
65
west
of
the
Cascade
Mountains
only,
and
the
tolerance
for
wild
rice
is
restricted
to
Minnesota.
Sufficient
field
trial
data
are
available
to
reassess
the
established
tolerances
with
regional
registrations
for
mint
and
wild
rice
at
the
same
levels.

3.
Codex
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
propiconazole
in/
on
various
raw
agricultural
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
propiconazole
per
se,
which
is
harmonized
with
the
US
tolerance
expression.
EPA
has
harmonized
tolerance
levels
on
most
commodities
with
Codex
MRLs
to
the
extent
possible.
A
comparison
of
the
Codex
MRLs
and
corresponding
reassessed
U.
S.
tolerances
is
presented
in
Table
30.

Table
30.
Codex
MRLs
for
Propiconazole
and
Applicable
U.
S.
Tolerances.
Current
Codex
MRLs
Commodity
(
As
Defined
by
Codex)
MRL
(
mg/
kg)
Step
Reassessed
U.
S.
Tolerance
(
ppm)
Recommendation
and
Comments
Almonds
0.05
CXL
N/
A
No
current
U.
S.
registration.

Banana
0.1
CXL
0.2*
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.

Barley
(
grain)
0.05
CXL
0.3*
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.
Coffee
beans
0.1
CXL
N/
A
No
current
U.
S.
registration.
Edible
offal
(
mammalian)
0.05
CXL
N/
A
No
current
U.
S.
registration.

Eggs
0.05
CXL
N/
A
MRL
set
at
limit
of
quantification
(
LOQ).
Current
U.
S.
tolerance
of
0.1
will
be
revoked
because
poultry
metabolism
data
show
no
finite
residues
in
eggs.
Grapes
0.5
CXL
N/
A
No
current
U.
S.
registration
Mango
0.05
CXL
N/
A
No
current
U.
S.
registration.
Meat
(
from
mammals
other
than
marine)
0.05
CXL
0.1*
MRL
set
at
LOQ.
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.

Milks
0.01
CXL
0.05*
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.
MRL
set
at
LOQ.
Oat
(
grain)
0.05
CXL
0.1
MRL
set
at
LOQ.

Peanut
0.05
CXL
0.1*
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.
Peanut,
whole
0.1
CXL
N/
A
Not
currently
regulated
by
U.
S.
EPA.

Pecan
0.05
CXL
0.1*
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.

Poultry
meat
0.05
CXL
N/
A
No
current
U.
S.
registration.
MRL
set
at
LOQ.
Rape
seed
0.05
CXL
N/
A
No
current
U.
S.
registration.

Rye
0.05
CXL
0.3*
MRL
set
at
LOQ.
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.

Stone
fruits
1.0
CXL
1.0
U.
S.
established
crop
group
tolerance
for
stone
fruits.
Sugar
beet
0.05
CXL
N/
A
No
current
U.
S.
registration.
Sugar
beet
leaves
or
tops
0.5
CXL
N/
A
No
current
U.
S.
registration.
66
Table
30.
Codex
MRLs
for
Propiconazole
and
Applicable
U.
S.
Tolerances.
Current
Codex
MRLs
Commodity
(
As
Defined
by
Codex)
MRL
(
mg/
kg)
Step
Reassessed
U.
S.
Tolerance
(
ppm)
Recommendation
and
Comments
Sugar
cane
0.05
CXL
N/
A
Registered
in
U.
S.
for
use
as
seed
piece
treatment,
which
is
considered
a
non
food
use.

Wheat
0.05
CXL
0.30*
Unable
to
harmonize
due
to
higher
U.
S.
use
rate.
MRL
set
at
LOQ.
*
US
Tolerance
cannot
be
harmonized
with
Codex
MRLs
because
US
GAP
requires
higher
tolerances
than
Codex
MRL.

4.
Residue
Analytical
Method
Plant
commodities.
Residue
methods
AG­
454,
AG­
454B
and
AG­
626
(
both
are
modification
of
method
AG­
454)
were
used
to
determine
residues
of
propiconazole
and
its
metabolites
on
samples
of
raw
agricultural
and
processed
commodities
from
field
trials
and
processing
studies.
The
methods
use
a
single
moiety
detection
in
which
residues
are
converted
to
2,4­
DCBA,
determined
as
the
2,4­
DCBA
methyl
ester,
and
reported
as
propiconazole
equivalents
using
a
conversion
factor
of
1.79.
The
reported
level
of
quantification
(
LOQ)
for
this
method
is
0.05
ppm.
Concurrent
method
recoveries
were
acceptable.
Previously,
EPA
required
enforcement
method
validation
for
Method
AG­
454A
using
bananas.
These
data
are
no
longer
needed.

For
enforcement
purposes,
residue
method
AG­
354
is
available
for
the
determination
of
propiconazole
per
se
in/
on
plant
commodities
using
gas
chromatography
and
flame
ionization
detection,
and
the
reported
LOQ
is
0.05
ppm.
The
Multiresidue
Methods
Section
302
(
Luke
Method;
Protocol
D)
also
picks
up
parent
propiconazole.

Animal
commodities.
Residue
methods
AG­
517
and
AG­
629
(
a
modification
of
method
AG­
517)
were
used
for
determination
of
propiconazole
and
its
metabolites
in
animal
commodities.
The
methods
use
a
single
moiety
detection
in
which
residues
are
converted
to
2,4­
DCBA,
determined
as
the
2,4­
DCBA
methyl
ester,
and
reported
as
propiconazole
equivalents
using
a
conversion
factor
of
1.79.
The
method
LOQ
is
0.05
ppm
for
residues
in
meat,
poultry,
and
eggs
and
0.02
ppm
for
residues
in
milk.
Samples
from
the
ruminant
and
poultry
feeding
studies
were
analyzed
using
method
AG­
359
(
an
early
version
of
method
AG­
517)
and
method
AG­
517.
For
enforcement
purpose,
the
Multiresidue
Methods
Section
302
(
Luke
Method;
Protocol
D)
picks
up
parent
propiconazole.

Multiresidue
methods.
The
October
1999
FDA
PESTDATA
database
(
PAM
Volume
I,
Appendix
I)
indicates
that
propiconazole
is
completely
recovered
(>
80%)
using
Multiresidue
Methods
Section
302
(
Luke
Method;
Protocol
D).
The
recovery
of
propiconazole
metabolites
CGA­
91305,
CGA­
118244,
and
1,2,4­
triazole
is
variable
using
Section
302.
Propiconazole
and
metabolites
CGA­
91305,
CGA­
118244,
and
1,2,4­
triazole
are
not
recovered
using
Multiresidue
Methods
Sections
303
(
Mills,
Onley,
and
Gaither;
Protocol
E,
nonfatty)
and
304
(
Mills,
fatty
food).
E.
Regulatory
Rationale
67
The
following
is
a
summary
of
the
rationale
for
mitigation
measures
necessary
for
managing
risks
associated
with
the
use
of
propiconazole
and
for
products
containing
propiconazole
to
be
eligible
for
reregistration.
Where
labelling
revisions
are
warranted,
specific
language
is
set
forth
in
Table
31
of
this
document.

1.
Human
Health
Risk
Management
a.
Aggregate
Risk
Mitigation
for
Propiconazole
Acute,
short­
term,
and
chronic
aggregate
risks
for
propiconazole
are
below
the
Agency's
level
of
concern.
EPA
has
considered
the
contribution
of
acute
and
chronic
dietary
exposure
from
food
and
drinking
water
as
well
as
exposures
to
residential
handlers
and
postapplication
residential
exposures
in
the
aggregate
risk
assessment
for
propiconazole.
Therefore,
no
mitigation
is
necessary
at
this
time.
However,
a
wood
wipe
study
is
required
for
propiconazole
to
confirm
EPA's
conclusions
on
post­
application
residential
exposure
to
treated
wood.

b.
Aggregate
Risk
Mitigation
for
Free
Triazoles
Acute,
short­
and
intermediate­
term,
and
chronic
aggregate
risks
for
the
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
mitigation
is
necessary
at
this
time.

c.
Occupational
Risk
Mitigation
A
wide
range
of
factors
is
considered
in
making
risk
management
decisions
for
worker
risks.
These
factors
include,
in
addition
to
the
estimated
MOEs,
incident
data,
the
nature
and
severity
of
adverse
effects
observed
in
the
animal
studies,
uncertainties
in
the
risk
assessment,
alternative
registered
pesticides,
the
importance
of
the
chemical
in
integrated
pest
management
(
IPM)
programs,
and
other
factors.
Mitigation
measures
may
include
reducing
application
rates,
adding
personal
protective
equipment
(
PPE)
to
end­
product
labels,
requiring
the
use
of
engineering
controls,
and
other
measures.

Occupational
exposure
assessments
are
completed
by
the
Agency
considering
the
use
of
baseline
PPE
and,
if
warranted,
for
handlers,
increasing
levels
of
PPE
and
engineering
controls
in
order
to
estimate
the
potential
impact
on
exposure
and
risk.
The
target
MOE
for
propiconazole
is
100,
based
on
information
provided
in
Section
III
of
this
document.
When
MOEs
for
occupational
risk
are
less
than
100,
EPA
strives
to
reduce
worker
risks
through
the
use
of
PPE
and
engineering
controls
or
other
mitigation
measures.
In
some
cases,
the
Agency
may
accept
MOEs
less
than
100
when
all
mitigation
measures
that
are
feasible
and
practical
have
been
applied,
particularly
when
there
are
critical
pest
management
needs
associated
with
the
use
of
the
pesticide.
68
Handler
Risk
Mitigation
Agricultural
Uses.
The
Agency
evaluated
handler
risks
for
both
liquid
and
wettable
powder
formulations
of
propiconazole.
For
liquid
formulations,
handler
risks
for
most
scenarios
were
of
concern
for
mixer/
loaders
wearing
baseline
clothing
(
long
sleeve
shirt,
long
pants,
shoes,
and
socks),
but
these
risks
can
be
mitigated
with
the
addition
of
chemicalresistant
gloves
(
i.
e.,
MOEs
with
gloves
are
>
100).
Therefore
all
handlers
using
liquid
formulations
of
propiconazole
must
wear
chemical­
resistant
gloves
and
all
labels
must
reflect
this
requirement.
For
wettable
powders,
which
are
all
formulated
in
water­
soluble
packs,
handler
risks
were
below
the
Agency's
level
of
concern
(
MOEs
are
>
100)
with
baseline
clothing.
Provided
that
all
wettable
powder
formulations
are
in
water­
soluble
packs,
no
additional
mitigation
is
necessary.
In
addition,
gloves
are
required
for
all
handlers
involved
in
seed
piece
treatments
or
dips
because
seed
piece
treatment
is
a
potentially
messy
operation.
All
current
propiconazole
labels
require
gloves
for
this
use.

Antimicrobial
Uses.
Material
Preservative.
The
Agency
evaluated
handler
risks
associated
with
use
of
propiconazole
as
a
material
preservative
in
paints,
caulks,
textiles,
and
as
a
wood
preservative.
When
propiconazole
is
used
as
a
material
preservative,
short­
term
handler
MOEs
range
from
<
1
to
6,500
at
baseline
(
long­
sleeved
shirt,
long
pants,
shoes
and
socks)
and
from
300
to
26,000
with
the
addition
of
chemical­
resistant
gloves.
Likewise,
intermediate­
term
handler
MOEs
range
from
<
1
to
2,200
at
baseline
and
100
to
8,600
with
chemical­
resistant
gloves.
Workers
applying
paint
containing
propiconazole
as
an
in­
can
preservative
have
a
combined
short­
term
MOE
of
75
for
airless
sprayer
and
intermediate­
term
MOEs
of
55
and
25,
for
brush/
roller
or
airless
sprayer,
respectively,
at
baseline.
Although
the
use
of
chemical­
resistant
gloves
improves
the
MOEs
for
painting,
EPA
cannot
require
workers
using
paint
containing
propiconazole
to
wear
gloves
because
paint
is
considered
a
treated
article
when
it
contains
propiconazole
as
an
in­
can
preservative.
Treated
articles
are
exempt
from
FIFRA
labeling
requirements.

To
mitigate
risk
to
painters,
the
registrant
has
agreed
to
decrease
the
amount
of
propiconazole
that
may
be
used
as
a
preservative
in
paint
from
0.35%
to
0.125%
a.
i.
When
paint
contains
0.125%
propiconazole,
MOEs
are
expected
to
increase
about
threefold,
resulting
in
short­
and
intermediate­
term
MOEs
for
painters
using
brush/
roller
>
100;
and
MOEs
for
painters
using
an
airless
sprayer
>
100
for
short­
term
exposure
and
~
75
for
intermediate­
term
exposure.
However,
there
is
some
uncertainty
in
the
dermal
component
of
these
MOEs
because
the
underlying
exposure
monitoring
data
is
from
cooling
tower
workers
(
no
gloves)
rather
than
from
painters,
and
only
two
replicates
are
available
for
cooling
tower
exposure.
Because
of
these
uncertainties,
the
Agency
is
requiring
additional
worker
exposure
monitoring
studies
for
painters
using
brush
rollers
and
airless
sprayers
as
confirmatory
data.
The
propiconazole
registrants
are
members
of
the
Antimicrobial
Exposure
Assessment
Task
Force
II
(
AEATF
II),
which
will
be
conducting
these
studies.
In
addition,
EPA
is
assuming
that
40%
of
propiconazole
in
paint
is
biologically
available
and
absorbed
through
the
skin,
based
on
a
rat
dermal
penetration
study
with
technical
grade
propiconazole.
However,
this
may
differ
from
the
absorption
of
propiconazole
in
paint
because
the
paint
matrix
may
limit
dermal
absorption.
Registrants
have
agreed
to
conduct
a
dermal
absorption
study
to
determine
how
much
propiconazole
is
absorbed
through
the
skin
when
this
chemical
is
suspended
in
a
69
paint
matrix.
EPA
is
requiring
a
dermal
absorption
study
for
a
paint
product
containing
propiconazole
as
part
of
this
RED.
At
this
time,
the
Agency
believes
that
reducing
the
percent
active
ingredient
in
paint
is
sufficient
to
mitigate
risk
concerns
for
painters,
given
the
uncertainties
in
underlying
exposure
monitoring
data
and
dermal
absorption
of
propiconazole
in
paint.

Wood
Preservative.
For
blender/
spray
operators,
chemical
operators,
and
diptank
operators,
short­
term
combined
MOEs
range
from
400
to
850
with
gloves,
and
intermediate­
term
MOEs
range
from
130
to
280
with
gloves.
Handler
MOEs
for
high­
pressure/
high
volume
spray
treatment
range
from
150
to
1,500
for
short­
term
exposure
and
from
50
to
500
for
intermediate­
term
exposure;
these
MOEs
assume
the
use
of
chemical­
resistant
gloves.
The
MOE
of
50
is
for
application
of
propiconazole
to
mushroom
houses
in
a
high
volume
spray
of
1000
gallons
per
day.
However,
according
to
Phase
3
comments
from
the
American
Mushroom
Institute,
no
more
than
100
gallons
are
applied
in
a
mushroom
house
in
a
given
day
(
MOE
is
500),
thus
addressing
the
risk
concern.
For
workers
pressure
treating
wood,
the
combined
short­
term
MOE
ranges
from
260
to
2,200
and
the
intermediate­
term
MOE
ranges
from
86
to
730
with
gloves.
For
workers
pressure
treating
wood,
the
combined
intermediate­
term
dermal
and
inhalation
MOE
is
86
with
gloves,
which
falls
within
the
negligible
risk
range.
Also,
EPA
used
monitoring
data
for
other
wood
preservatives
to
estimate
handler
exposure
to
propiconazole
used
as
a
wood
preservative.
This
assumes
that
the
exposure
patterns
at
treatment
facilities
using
other
wood
preservatives
would
be
the
same
as
for
propiconazole.
Given
this
uncertainty,
no
mitigation
is
warranted
at
this
time,
but
a
confirmatory
worker
monitoring
study
for
pressure
treatment
of
wood
will
be
required
as
part
of
this
RED.
Registrants
have
agreed
to
conduct
this
additional
worker
exposure
monitoring
study.

Post­
Application
Worker
Risk
Mitigation
Agricultural
Uses.
Agricultural
workers
re­
entering
sites
previously
treated
with
propiconazole
have
short­
term
MOEs
ranging
from
150
to
36,000
on
the
day
of
pesticide
application.
Because
these
MOEs
are
all
below
the
Agency's
level
of
risk
concern,
no
mitigation
is
necessary.
Intermediate­
term
MOEs
for
re­
entry
workers
range
from
97
(
for
cut
flowers)
to
37,000.
However,
all
MOES
are
>
100
on
the
day
after
pesticide
application;
including
the
MOE
for
cut
flowers,
which
is
104.
Although
the
MOE
on
is
slightly
less
than
100
on
day
0,
EPA
considers
this
MOE
of
97
to
be
within
the
same
negligible
risk
range
as
the
MOE
of
104
on
day
1.
Therefore,
the
Agency
does
not
believe
that
the
risk
reduction
justifies
a
24
hour
REI
for
propiconazole.
The
current
restricted­
entry
interval
(
REI)
for
propiconazole
is
12
hours
on
some
labels;
which
is
consistent
with
the
Worker
Protection
Standard
(
WPS)
requirement
based
on
the
acute
toxicity
of
technical
propiconazole
(
Toxicity
Category
III).
The
REI
may
increase
depending
on
the
toxicity
of
propiconazole
end­
use
products;
this
will
be
determined
during
product
reregistration.

Antimicrobial
Uses.
Machinists
who
are
exposed
to
propiconazole
in
metal
working
fluids
have
a
combined
short­
term
inhalation
and
dermal
MOE
of
4,800
and
a
combined
intermediate­
term
MOE
of
1,600.
Because
these
MOEs
are
>
100,
and
below
the
Agency's
level
of
concern,
no
mitigation
is
needed
for
post­
application
risk
from
metalworking
fluids.
Saw
mill
workers
who
are
exposed
to
wood
after
it
is
treated
have
short­
term
dermal
MOEs
70
ranging
from
150
to
2,700
and
inhalation
MOEs
ranging
from
150
to
5,500.
Intermediateterm
MOEs
(
for
workers
exposed
for
a
longer
duration)
range
from
51
to
2000
for
dermal
exposure
and
1,900
to
44,000
for
inhalation
exposure.
Intermediate­
term
dermal
MOEs
are
of
concern
only
for
one
scenario:
workers
performing
clean
up
activities.
However,
these
MOEs
are
based
on
data
for
a
surrogate
chemical,
which
is
also
used
as
a
wood
preservative
in
saw
mills,
but
with
a
different
percent
active
ingredient,
application
rates,
etc.
As
previously
mentioned,
there
are
no
adequate
data
showing
how
much
propiconazole
residue
is
dislodged
from
treated
wood.
As
a
result,
EPA
believes
that
the
risk
to
clean
up
crew
workers
is
an
overestimate
and
risks
are
not
of
concern.
Moreover,
all
other
exposure
scenarios
for
this
industry
are
low
and
not
of
concern,
and
it
is
not
practical
to
impose
restrictions.
To
address
these
uncertainties
EPA
is
requiring
confirmatory
exposure
monitoring
data
for
postapplication
workers
handling
wood
treated
with
propiconazole
as
well
as
the
confirmatory
wood
wipe
study
previously
mentioned.

2.
Non­
Target
Organism
(
Ecological)
Risk
Management
Ecological
risk
mitigation
measures
may
include
lowering
application
rates,
reducing
the
number
of
applications
allowed
in
a
year,
restricting
the
timing
of
applications,
extending
the
time
between
applications,
and
changing
pesticide
use
to
minimize
runoff
or
spray
drift.
In
some
situations,
certain
uses
or
application
methods
may
need
to
be
deleted
to
address
ecological
risk
concerns.

The
screening­
level
risk
assessment
for
propiconazole
suggests
that
exposure
to
propiconazole
is
likely
to
result
in
some
exceedance
of
EPA's
acute
or
endangered
species
LOC
for
birds,
mammals,
terrestrial
and
aquatic
plants,
and
chronic
LOC
for
mammals.
However,
for
birds,
the
acute
RQ
of
0.53
is
very
close
to
the
LOC
of
0.5.
The
Agency
has
addressed
these
risk
concerns
to
the
extent
feasible
while
considering
some
of
the
factors
listed
above.
Specific
risk
mitigation
measures
are
described
in
the
following
sections.

EPA
does
not
currently
have
enough
chronic
toxicity
data
to
quantify
risks
for
propiconazole
for
freshwater
invertebrates
(
Daphnia)
and
estuarine/
marine
fish,
because
of
outstanding
data
requirements
from
a
previous
DCI.
Chronic
toxicity
data
must
be
submitted
to
support
the
continued
registration
of
propiconazole.

a.
Terrestrial
Organisms
Birds
and
Mammals
Mammals.
Acute
mammalian
RQs
for
propiconazole
are
below
the
LOC
for
all
propiconazole
uses
except
turf.
The
acute
mammalian
RQs
for
turf
exceeded
the
listed
species
LOC
for
mammals
feeding
on
short
grass,
tall
grass,
or
broadleaf
forage
and
small
insects.
Acute
RQs
for
multiple
applications
of
propiconazole
to
turf
exceeded
the
acute
LOC
of
0.5
for
15
g
and
35
g
smaller
mammals
in
the
short
grass
food
category
only.
When
the
Agency
revised
the
RQs
for
turf
using
chemical­
specific
data
on
foliar
dissipation
half­
life,
rather
than
the
35
day
default
used
in
the
original
screening­
level
risk
assessment,
only
acute
RQs
for
small
mammals
feeding
on
short
grass
exceeded
the
LOC.
However,
with
the
revised
RQs,
the
listed
species
LOC
of
0.1
is
71
exceeded
for
all
weight
classes
of
mammals
feeding
on
short
grass,
tall
grass,
and
broadleaf
plants
and
small
insects.
In
the
screening­
level
risk
assessment
for
propiconazole,
EPA
used
the
labeled
turf
application
rate
of
1.78
lbs
ai/
A
with
2­
4
applications
per
year.
Actual
use
data
show
that
much
lower
rates
and
fewer
applications
are
used,
even
in
the
states
with
the
greatest
use.

Although
the
revised
RQs
were
calculated
with
propiconazole­
specific
foliar
dissipation
data,
the
data
set
was
small.
The
resulting
RQs
could
overestimate
or
underestimate
potential
risk
to
mammals.
Therefore,
a
confirmatory
foliar
dissipation
study
is
required
as
part
of
this
RED.
This
study
would
measure
dissipation
of
propiconazole
over
time
from
foliage
of
several
representative
crop
groups.

Chronic
risks
to
mammals
were
calculated
using
both
the
dietary
and
dose­
based
RQs.
Dietary
based
mammalian
RQs
based
on
maximum
residues
ranged
from
1.1
to
2.6
and
exceeded
the
chronic
LOC
for
multiple
applications
to
turf.
However,
dose­
based
chronic
RQs
were
as
high
as
13
for
mammals
foraging
in
short
grass
following
multiple
applications
of
propiconazole
to
turf.
For
turf,
chronic
RQs
only
begin
to
exceed
LOCs
after
the
3rd
application
and
no
chronic
LOCs
are
exceeded
after
2
applications.
RQs
based
on
mean
residues
would
be
lower.
Acute
risks
would
also
be
lower
based
on
fewer
applications.
All
other
exposure
scenarios
resulted
in
RQs
below
the
Agency's
LOC.
When
EPA
refined
the
chronic
dose­
based
RQs
as
mentioned
above,
the
only
chronic
RQs
exceeding
the
LOC
are
for
small
mammal
feeding
on
short
grass
following
application
of
propiconazole
to
pecans
(
the
RQ
of
1.04
only
barely
exceeds
the
LOC
of
1).
For
turf,
chronic
RQs
exceed
the
Agency's
chronic
LOC
for
mammals
feeding
on
grasses,
broadleaf
plants,
and
small
insects.

The
greatest
use
of
propiconazole
on
turf
occurs
in
the
Midwestern
United
States,
New
York,
and
Pennsylvania.
EPA
proprietary
data
show
that
lawn
care
operators
applied
15,000
lbs
annually,
and
turf
management
and
nursery
and
greenhouse
operations
applied
75,000
lbs
annually
from
1998
to
2001.
Average
annual
application
rates
to
golf
course
turf
range
from
0.2
to
1.3
lbs
ai/
A,
with
17
states
reporting
annual
use
propiconazole
at
an
average
annual
rate
of
0.5
lb
ai/
A
or
less.
In
states
with
the
greatest
use,
the
average
annual
application
rate
ranged
from
0.7
to
1.2
lbs
ai/
A.
The
mammalian
RQs
presented
above
are
based
on
multiple
applications
at
the
labelled
application
rate
of
1.78
lbs
ai/
A,
and
are
therefore
believed
to
overstate
risk
to
mammals
from
typical
use.

Birds.
Avian
acute
RQs
only
exceed
the
Agency's
LOC
of
0.5
for
turf
and
ornamental
uses,
when
the
smallest
weight
class
of
birds
feeding
on
short
grass
following
multiple
propiconazole
applications;
for
this
scenario
acute
RQs
range
from
0
to
0.7.
When
these
RQs
were
refined
by
using
chemical­
specific
foliar
dissipation
half­
life
data,
only
the
RQ
of
0.53
for
the
smallest
weight
class
of
birds
feeding
on
short
grass
exceeded
the
LOC
of
0.5.
Also,
based
on
predicted
maximum
residues
and
multiple
applications
to
turf
and
ornamentals,
acute
RQs
exceed
the
listed
species
LOC
of
0.1
for
all
weight
classes
of
birds
feeding
on
short
grass
and
tall
grass
and
for
smaller
birds
feeding
on
broadleaf
forage
and
small
insects.
Based
on
predicted,
mean
residues
resulting
from
multiple
applications
to
turf
and
ornamentals,
only
birds
feeding
on
short
grass
exceed
the
endangered
species
LOC.
Avian
RQs
did
not
exceed
LOCs
for
any
other
uses.

Dietary­
based
chronic
avian
RQs
slightly
exceed
the
LOC
for
the
turf
use.
However,
the
72
chronic
toxicity
study
for
birds
showed
no
treatment­
related
effects
at
any
of
the
test
levels
up
to
1000
mg/
kg
diet
and,
as
such,
a
LOAEC
could
not
be
determined.
Consequently,
the
actual
NOAEC
could
be
much
greater
than
that
observed
in
the
study
used
to
assess
chronic
avian
risk
and
the
RQs
could
be
lower.
Dietary­
based
chronic
avian
RQs
only
slightly
exceeded
the
LOC
of
1
for
multiple
applications
to
turf;
the
highest
RQ
was
1.3.
In
addition,
when
these
RQs
were
further
refined
by
using
chemical­
specific
foliar
dissipation
half­
life
data,
the
maximum
RQ
is
1.02
and
equivalent
to
the
chronic
LOC
of
1.
Therefore,
at
this
time,
EPA
does
not
have
a
concern
for
chronic
risks
to
birds
and
no
mitigation
is
necessary.

Non­
Target
Insects
EPA
does
not
have
sufficient
data
to
determine
whether
propiconazole
use
poses
potential
risks
to
non­
target
insects.
However,
the
Agency
does
not
expect
adverse
effects
to
insects
because
propiconazole
does
not
cause
adverse
effects
to
soil
microbes
or
earthworms.

Plants
Propiconazole
poses
a
potential
risk
to
terrestrial
plants
for
some
uses.
Non­
listed
and
listed
species
RQs
resulting
from
single
applications
of
propiconazole
range
from
<
1
to
7.95.
RQs
exceed
the
LOC
for
nonlisted
dicots
based
on
use
on
turf
and
listed
dicots
based
on
use
in
grasses
grown
for
seed,
rice,
wild
rice,
peanut,
and
turf
use.
Dicot
RQs
for
a
single
application
of
propiconazole
to
turf
and
ornamentals
range
from
0.59
to
2.47
for
non­
listed
species
and
0.32
to
7.95
for
listed
species.
Monocot
RQs
exceed
only
the
LOC
for
listed
species
following
a
single
application
to
turf
and
ornamentals;
no
other
RQs
exceed
the
LOC.
As
previously
mentioned,
the
RQ
for
turf
and
ornamentals
assumes
application
to
turf
at
the
maximum
label
rate
1.78
lb
ai/
A;
which
is
greater
than
the
actual
rates
used
on
turf
(
maximum
of
0.7
to
1.2
lbs
ai/
A).

As
previously
mentioned,
underlying
assumptions
used
to
derive
plant
RQs
introduce
some
uncertainty
into
the
conclusions
of
the
screening­
level
risk
assessment.
For
example,
the
Terr­
PLANT
model
assumes
that
2%
for
propiconazole
is
lost
to
runoff
from
each
of
ten
acres
of
a
treated
field
to
non­
target
plants
adjacent
to
the
treated
field.
The
Agency
is
currently
developing
a
plant
exposure
model
which,
among
other
things,
will
use
PRZM
to
estimate
the
amount
of
pesticide
in
runoff
based
on
the
persistence
and
mobility
of
the
chemical,
and
soil
and
weather
data
in
specific
crop
scenarios.
Although
this
refined
exposure
model
is
not
yet
available,
the
transport
of
propiconazole
in
runoff
from
use
on
turf
was
estimated
by
PRZM
as
part
of
the
aquatic
risk
assessment,
and
can
be
used
to
further
characterize
the
potential
for
risk
to
terrestrial
dicots.

The
TERR­
PLANT
model
assumed
an
EEC
of
0.36
lb
ai/
A
from
a
single
application
of
1.78
lb
ai/
A
on
turf.
The
transport
of
propiconazole
from
the
peak
runoff
event
for
each
of
30
years
simulated
by
PRZM
ranged
from
0.009
lb
ai/
A
to
0.245
lb
ai/
A.
These
EECs,
which
reflect
4
applications
of
propiconazole
at
1.78
lb
ai/
A,
would
result
in
acute
RQs
ranging
from
0.05
to
1.4
if
used
in
the
risk
assessment.
Peak
storm
events
simulated
by
PRZM
would
result
in
RQs
at
or
above
the
LOC
of
1.0
in
7
of
the
30
years
simulated,
indicating
a
potential
risk
to
plants
adjacent
to
treated
fields
under
certain
conditions
if
the
maximum
rate
and
number
of
applications
are
applied.
Use
data
indicate
that
typical
rates
in
the
states
with
the
greatest
use
range
from
0.7
to
1.2
lbs
ai/
A
73
per
year.
Since
these
typical
rates
are
at
least
one­
third
less
than
the
maximum
rate,
the
25%
effect
on
seedling
emergence
represented
by
the
toxicity
endpoint
might
occur
even
less
frequently
than
suggested
by
the
PRZM
model
output.

The
Agency
believes
that
the
label
changes
to
address
spray
drift
will
also
reduce
potential
risks
to
terrestrial
plants.
The
Ag­
DRIFT
model
shows
deposition
of
fine
to
medium
size
spray
droplets
at
levels
equal
to
the
vegetative
vigor
EC25
at
distances
ranging
from
3
to
43
feet
from
the
treated
field.
The
spray
drift
mitigation
will
require
use
of
medium
coarse
to
coarse
spray
droplets
to
minimize
drift.
This
larger
droplet
size
is
expected
to
reduce
the
distance
from
the
treated
field
at
which
nontarget
plants
would
be
at
risk
for
adverse
effects
(
vegetative
vigor).
If
one
runs
an
Ag­
DRIFT
simulation
using
this
larger
droplet
size
spectrum,
RQs
for
the
three
less
sensitive
plants
would
be
below
the
the
LOC
at
distances
beyond
3
feet
from
the
treated
field;
and
the
RQ
for
the
most
sensitive
plant
would
be
below
the
LOC
at
distances
beyond
13
feet
from
the
field.
The
distance
to
which
deposition
is
at
or
above
the
LOC
for
the
aerial
application
to
grass
grown
for
seed,
pecans,
rice,
wild
rice
and
peanuts
is
reduced
from
49
feet
to
26
feet,
based
on
the
most
sensitive
plant
tested.
As
with
seedling
emergence,
the
vegetative
vigor
LOC
represents
an
effect
(
mainly
plant
height
here,
or
dry
weight)
to
25%
of
test
plants.
The
distance
to
which
the
endangered
species
LOC
(
based
on
the
no
observed
adverse
effect
level)
is
met
is
reduced
by
spray
drift
mitigation
from
92
feet
to
33
feet
for
the
turf
use,
and
from
118
feet
to
75
feet
for
the
aerial
uses
at
0.225
lb
ai/
A,
based
on
the
most
sensitive
plant
tested.

b.
Aquatic
Organisms
Freshwater
Fish
and
Invertebrates
All
RQs
for
freshwater
fish
and
invertebrates
are
less
than
the
Agency's
LOC
of
0.5
for
acute
risk.
These
RQs
are
considered
to
be
conservative
because
they
are
based
on
the
maximum
1
in
10
year
peak
surface
water
concentrations
and
the
most
sensitive
96­
hour
LC50
values
for
fish
and
aquatic
invertebrates.
For
endangered
species,
however,
the
freshwater
fish
RQ
is
equal
to
the
acute
listed
species
LOC
of
0.05
based
on
EECs
in
surface
water
from
turf
use
in
Pennsylvania,
but
does
not
exceed
based
on
EECs
in
surface
water
from
turf
use
in
Florida.

Chronic
RQs
for
freshwater
fish
do
not
exceed
the
Agency's
chronic
LOC
of
1
based
on
average
surface
water
concentrations
of
propiconazole
resulting
from
the
highest
exposure
scenarios,
for
use
on
turf
and
rice,
and
available
toxicity
data.
As
previously
mentioned,
the
Agency
does
not
have
sufficient
data
to
assess
chronic
risks
from
propiconazole
uses
to
estuarine/
marine
fish
or
freshwater
invertebrates.

Estuarine/
Marine
Fish
and
Invertebrates
The
Agency's
screening­
level
risk
assessment
shows
that
RQs
for
estuarine/
marine
fish
do
not
exceed
the
acute
LOC
for
any
use,
but
exceed
the
listed
species
LOC
for
the
rice
use.
The
estuarine/
marine
invertebrate
acute
RQs
exceed
the
acute
listed
species
LOC
(
0.05)
from
the
highest
exposure
scenarios,
for
use
on
turf
and
rice.
The
risk
assessments
must
be
further
refined
to
determine
whether
propiconazole
use
on
turf
or
rice
is
likely
to
occur
in
areas
inhabited
by
74
endangered
species.
As
previously
mentioned,
the
acute
RQs
are
based
on
conservative
inputs,
including
the
maximum
1­
in­
10
year
peak
EEC
and
the
most
sensitive
90­
hour
LC50
value.
In
addition,
the
modeled
application
rate
for
turf
is
higher
than
what
is
actually
used,
even
in
the
areas
of
greatest
use.
Furthermore,
only
one
application
of
propiconazole
is
made
to
rice
in
most
states,
but
two
applications
were
modeled.
No
levels
of
concern
were
exceeded
for
any
other
crops.

Chronic
RQs
for
estuarine/
marine
invertebrates
do
not
exceed
the
Agency's
chronic
LOC
of
1
based
on
average
surface
water
concentrations
of
propiconazole
resulting
from
both
the
turf
and
rice
scenarios
and
available
toxicity
data.
As
previously
mentioned,
EPA
does
not
have
sufficient
data
to
assess
chronic
risks
from
propiconazole
uses
to
estuarine/
marine
fish.

Plants
RQs
for
freshwater
vascular
plants
based
on
both
turf
and
rice
use
and
the
RQs
for
freshwater
non­
vascular
plants
based
on
turf
use
do
not
exceed
the
LOC.
The
use
of
propiconazole
on
rice
and
turf
may
present
risk
to
non­
vascular
estuarine/
marine
plants;
both
the
acute
and
listed
species
RQs
exceed
the
LOC
of
1.
In
addition,
the
use
of
propiconazole
on
rice
may
present
an
acute
risk
to
freshwater
non­
vascular
plants;
the
listed
species
RQs
exceed
the
LOC
of
1.
However,
as
previously
stated,
the
RQs
are
based
on
higher
than
typical
application
rates
for
turf,
and
the
RQs
for
rice
are
based
on
two
applications,
where
one
application
is
commonly
used.

3.
Summary
of
Mitigation
Measures
The
following
mitigation
measures
are
necessary
for
the
active
ingredient
propiconazole
and
for
end­
use
products
containing
propiconazole
to
be
eligible
for
reregistration.
These
include
use
restrictions,
voluntary
cancellations
and/
or
use
deletions,
and
personal
protective
equipment.

 
Handlers
using
liquid
formulations
of
propiconazole
for
agricultural
use
must
wear
chemical­
resistant
gloves;
 
Handlers
using
propiconazole
for
seed
piece
treatment
or
dips
must
wear
chemicalresistant
gloves;
 
Wettable
powder
formulations
of
propiconazole
must
be
packaged
in
water­
soluble
bags;
 
Decrease
the
amount
of
propiconazole
that
may
be
used
as
a
preservative
in
paint
from
0.35%
to
0.125%
a.
i.;
and
 
Label
restrictions
to
minimize
spray
drift,
including
restrictions
on
droplet
size
and
application
height.

Because
the
technical
registrants
have
requested
that
the
following
uses
be
deleted
from
all
labels,
they
are
not
eligible
for
reregistration:

 
Use
of
propiconazole
on
apparel,
carpet
fibers,
and
home
furnishings
Registrants
have
requested
that
their
registration
be
amended
to
delete
these
uses;
and
EPA
issued
a
formal
order
deleting
these
uses
on
May
26,
2006.
Therefore,
these
uses
are
not
being
75
considered
for
reregistration.

F.
Other
Labeling
Requirements
To
be
eligible
for
reregistration,
various
use
and
safety
information
will
be
included
in
the
labeling
of
all
end­
use
products
containing
propiconazole.
For
the
specific
labeling
statements
and
a
list
of
outstanding
data,
refer
to
Section
V
of
this
RED
document.

1.
Endangered
Species
Considerations
As
stated
in
Chapter
III
of
this
document,
the
Agency's
screening­
level
assessment
preliminary
risk
assessment
for
propiconazole
indicates
a
potential
for
adverse
effects
on
listed
species
as
noted
below,
should
exposure
actually
occur
at
modeled
levels:

Terrestrial
organisms
 
Mammals
o
Acute
RQs
for
turf
and
ornamentals
exceed
LOCs
for
small
mammals
feeding
on
short
grass,
tall
grass,
broadleaf
forage
and
small
insects;
o
Chronic
RQs
for
turf
and
ornamentals
exceed
LOC
for
all
mammals
feeding
on
short
grass,
tall
grass,
broadleaf
forage
and
small
insects;
 
Birds
o
Acute
RQs
for
turf
and
ornamentals
exceed
LOCs
for
all
birds
feeding
on
short
grass
and
tall
grass
and
for
smaller
birds
feeding
on
broadleaf
forage
and
small
insects;
o
Chronic
RQs
for
turf
and
ornamentals
barely
exceed
the
LOC.
Although
these
RQs
were
based
on
a
study
that
showed
no
effects
at
the
highest
dose
tested;
EPA
cannot
preclude
potential
adverse
effects
to
listed
species;
 
Plants
o
Acute
RQs
for
turf
and
ornamentals
exceed
LOCs
for
listed
terrestrial
plants
(
monocots
and
dicots)
adjacent
to
treated
sites
and
in
semiaquatic
areas;
o
Acute
RQs
for
grasses
grown
for
seed,
rice,
and
peanuts
are
equal
to
the
LOC
for
dicots
in
semi­
aquatic
areas;
Aquatic
Organisms
 
Freshwater
o
Acute
fish
RQ
for
Pennsylvania
turf
is
equal
to
LOC
for
listed
species;
Florida
turf
scenario
does
not
exceed
LOC;
o
Acute
fish
RQ
for
rice
exceeds
LOC
for
listed
species;
o
Because
no
data
are
available
to
evaluate
chronic
risks
to
freshwater
invertebrates,
EPA
has
a
potential
concern
for
listed
species;
 
Estuarine/
Marine
o
Acute
invertebrate
RQs
for
turf
and
rice
exceed
LOC
for
listed
species;
o
Because
no
data
are
available
to
evaluate
chronic
risks
to
estuarine/
marine
fish,
EPA
has
a
potential
concern
for
listed
species;
 
Plants
76
o
Acute
RQs
for
turf
exceed
LOCs
for
listed
estuarine/
marine
nonvascular
plants;
and
o
Acute
RQs
for
rice
exceed
LOCs
for
listed
freshwater
and
estuarine/
marine
nonvascular
plants.

Further,
potential
indirect
effects
to
any
species
dependent
upon
a
species
that
experiences
effects
from
use
of
propiconazole
cannot
be
precluded
based
on
the
screening­
level
ecological
risk
assessment.
These
findings
are
based
solely
on
EPA's
screening­
level
assessment
and
do
not
constitute
"
may
affect"
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
(
ESA)
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
it
in
relation
to
individual
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species,
as
part
of
a
refined
species­
specific
analysis.
When
conducted,
this
species­
specific
analysis
will
take
into
consideration
any
regulatory
changes
recommended
in
this
RED
being
implemented
at
that
time.

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
propiconazole;
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
propiconazole
"
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
propiconazole
at
levels
of
concern.
EPA
is
not
requiring
specific
propiconazole
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.

2.
Spray
Drift
Management
The
Agency
has
been
working
closely
with
stakeholders
to
develop
improved
approaches
for
mitigating
risks
to
human
health
and
the
environment
from
pesticide
spray
and
dust
drift.
As
part
of
the
reregistration
process,
EPA
will
continue
to
work
with
all
interested
parties
on
this
important
issue.

From
its
assessment
of
propiconazole,
as
summarized
in
this
document,
the
Agency
concludes
that
certain
drift
mitigation
measures
are
needed
to
address
the
risks
from
off­
target
drift
for
propiconazole,
including
a
requirement
for
medium
to
coarse
droplet
size.
Label
77
statements
implementing
these
measures
are
listed
in
the
"
spray
drift
management"
section
of
the
label
table
(
Table
31)
in
Section
V
of
this
RED
document.
In
the
future,
propiconazole
product
labels
may
need
to
be
revised
to
include
additional
or
different
drift
label
statements.

V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
propiconazole
is
eligible
for
reregistration,
provided
that
the
risk
mitigation
measures
outlined
in
this
document
are
adopted
and
label
amendments
are
made
to
reflect
these
measures.
To
implement
the
risk
mitigation
measures,
the
registrants
will
be
required
to
amend
their
product
labeling
to
incorporate
the
label
statements
set
forth
in
the
Label
Summary
Table
(
Table
31).
In
the
near
future,
the
Agency
intends
to
issue
Data
Call­
In
Notices
(
DCIs)
requiring
label
amendments,
product
specific
data
and
additional
generic
(
technical
grade)
data.
Generally,
registrants
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
request
time
extension
and/
or
waiver
requests
with
a
full
written
justification.
For
product­
specific
data,
the
registrant
will
have
eight
months
to
submit
data
and
amended
labels.
For
generic
data,
due
dates
can
vary
depending
on
the
specific
studies
being
required.
Below
are
tables
of
additional
generic
data
and
label
amendments
that
the
Agency
intends
to
require
for
propiconazole
to
be
eligible
for
reregistration.

A.
Manufacturing
Use
Products
1.
Generic
Data
Requirements
The
generic
database
supporting
the
reregistration
of
propiconazole
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
there
are
a
few
outstanding
generic
data
requirements
for
residue
chemistry,
aquatic
toxicity,
and
environmental
fate
remaining,
which
must
fulfilled
to
support
the
continued
registration
of
propiconazole.
(
See
Data
Gaps
listed
in
Appendix
B.)
These
outstanding
data
requirements,
were
included
in
previous
DCIs
and
therefore
will
not
be
included
in
the
generic
DCI
for
this
RED.

In
addition,
the
Agency
has
identified
data
necessary
to
confirm
the
registration
eligibility
decision
for
propiconazole.
These
studies
are
listed
herein
and
will
be
included
in
the
generic
DCI
for
this
RED,
which
the
Agency
intends
to
issue
at
a
future
date.
78
Human
Health
OPPTS
860.1200
Directions
for
Use
for
Sunflower
Breeder's
Seed
OPPTS
860.1500
Crop
Field
Trials
for
Sunflower
Breeder's
Seed
OPPTS
GDLN
870.7600
Dermal
Penetration
(
for
Paint
Containing
Propiconazole)

OPPTS
GDLN
875.1200
Dermal
Exposure
 
Indoor,
for
the
following
scenarios:
o
Painters
using
brush/
roller
o
Painters
using
airless
sprayer
o
Workers
pressure
treating
wood
o
Workers
handling
treated
wood
OPPTS
GDLN
875.1400
Inhalation
Exposure
 
Indoor,
for
the
following
scenarios:
o
Painters
using
brush/
roller
o
Painters
using
airless
sprayer
o
Workers
pressure
treating
wood
o
Workers
handling
treated
wood
OPPTS
GDLN
875.1100
Dermal
Exposure
 
Outdoor,
for
painters
using
brush
roller
and
airless
sprayer
OPPTS
GDLN
875.1300
Inhalation
Exposure
 
Outdoor,
Outdoor,
for
painters
using
brush
roller
and
airless
sprayer
Ecological
Effects
OPPTS
GDLN
876.7200
Soil
Residue
Dissipation
 
modified
for
foliage
dissipation
Special
Studies
Dislodgeable
Residues
of
Propiconzole
from
treated
Wood
(
wood
wipe
study
for
dimensional
lumber)

Data
Requirements
for
Free
Triazoles
The
Agency
is
also
requiring
additional
data
for
the
free
triazoles,
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid.
However,
any
DCIs
for
the
free
triazoles
will
be
issued
separately
from
the
DCI
for
propiconazole.

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
Table
31.
79
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.
The
Agency
intends
to
issue
a
separate
productspecific
data
call­
in
(
PDCI)
outlining
specific
data
requirements.

2.
Labeling
for
End­
Use
Products
To
be
eligible
for
reregistration,
labeling
changes
are
necessary
to
implement
measures
outlined
in
Section
IV
above.
Revised
labels
are
due
8
months
from
the
date
of
receipt
of
the
PDCI
mentioned
above.
Specific
language
to
incorporate
these
changes
is
provided
in
Table
31.
Generally,
conditions
for
the
distribution
and
sale
of
products
bearing
old
labels/
labeling
will
be
established
when
the
label
changes
are
approved.
However,
specific
existing
stocks
time
frames
will
be
established
case­
by­
case,
depending
on
the
number
of
products
involved,
the
number
of
label
changes,
and
other
factors.

C.
Labeling
Changes
Summary
Table
For
propiconazole
to
be
eligible
for
reregistration,
all
propiconazole
labels
must
be
amended
to
incorporate
the
risk
mitigation
measures
outlined
in
Section
IV.
Table
31
describes
how
language
on
the
labels
should
be
amended.

D.
Existing
Stocks
Registrants
may
generally
distribute
and
sell
products
bearing
old
labels/
labeling
for
18
months
after
the
date
of
approval
of
revised
labels
implementing
the
changes
described
in
this
RED.
Others,
including
end­
use
registrants,
may
generally
sell,
distribute,
and
use
existing
stocks
bearing
previously
approved
labeling
until
these
existing
stocks
have
been
exhausted,
provided
such
sale,
distribution,
and
use
are
in
accordance
with
previously
approved
labeling.
Existing
stocks
are
defined
as
stocks
of
registered
pesticide
products
currently
in
the
United
States,
which
have
been
packaged,
labeled,
and
released
for
shipment.
EPA's
existing
stocks
policy
is
described
in
the
Federal
Register
of
June
26,
1991
(
56
FR
29362;
FRL­
3846­
4).
80
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
Manufacturing
Use
Products
For
all
Manufacturing
Use
Products
"
Only
for
formulation
into
a
fungicide/
material
preservative/
wood
preservative
for
the
following
uses:
­

[
Registrant,
please
insert]."

"
Unless
packaged
in
water­
soluble
packaging,
this
product
may
not
be
formulated
into
wettable
powder
end­
use
products."

"
This
product
may
not
be
formulated
into
end­
use
products
for
use
in
carpet
fibers,
apparel,
and
furnishings
(
except
shower
curtains)."

"
This
product
may
not
be
formulated
into
paints
and
stains
unless
the
maximum
concentration
of
propiconazole
is
less
than
or
equal
to
0.125%
by
weight."
Directions
for
Use
Environmental
Hazards
Statements
"
ENVIRONMENTAL
HAZARDS"

"
This
product
is
toxic
to
fish
and
shrimp.
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
Eliminations
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
Environmental
Protection
Agency."
Precautionary
Statements:

Environmental
Hazards
81
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
End­
Use
Products
Intended
for
Occupational
Use
(
WPS
and
Non­
WPS)

PPE
Requirements*
for
Wettable
Powder
(
WP)

Formulations.

Wettable
Powder
products
labeled
for
use
on
agricultural
or
ornamental
crops
must
be
packaged
in
water
soluble
packaging
to
be
eligible
for
reregistration.
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
[
Registrant,
please
insert
correct
material(
s).]
Follow
the
instructions
for
category
[
insert
A,
B,
C,
D,
E,
F,
G,
or
H]
on
the
chemicalresistance
category
selection
chart
in
the
EPA
Label
Review
Manual,
3rd
Edition
(
EPA­
735­
B­
03­
001,

August
2003).

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

­
long­
sleeved
shirt
and
long
pants,

­
shoes
and
socks."

"
In
addition.
mixers/
loader
must
wear
­
chemical­
resistant
gloves
and
­
a
chemical­
resistant
apron."

"
All
handlers
using
propiconazole
as
a
seed
piece
treatment
must
wear
­
chemical­
resistant
gloves
and
­
a
chemical­
resistant
apron."

"
See
Engineering
Controls
for
additional
requirements."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
82
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
PPE
Requirements*
for
Liquid
Concentrate
Formulations
For
all
liquid
formulations
labeled
for
use
on
agricultural
or
ornamental
crops,
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
[
registrant
inserts
correct
material(
s)]."

For
more
options,
follow
the
instructions
for
category
[
insert
A,
B,
C,
D,
E,
F,
G
or
H]
on
the
chemicalresistance
category
selection
chart
in
the
EPA
Label
Review
Manual,
3rd
Edition
(
EPA­
735­
B­
03­
001,

August
2003).

"
All
handlers
must
wear:

­
long­
sleeved
shirt
and
long
pants,

­
shoes
and
socks,
and
­
chemical­
resistant
gloves."

"
In
addition,
all
handlers
(
mixers,
loaders,
and
applicators,
or
individuals
performing
one
or
more
of
these
tasks),
who
are
applying
this
pesticide
using
hand­
held
equipment
must
wear
­
long­
sleeved
shirt
and
long
pants,

­
shoes
and
socks,
and
­
chemical­
resistant
gloves."

"
All
handlers
using
propiconazole
as
a
seed
piece
treatment
must
wear
­
chemical­
resistant
gloves
and
­
a
chemical­
resistant
apron.
"
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
83
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
PPE
Requirements*
for
Liquid
Concentrate
Formulations
For
all
liquid
formulations
labeled
for
use
as
a
material
preservative
or
wood
preservative.
"
Personal
Protective
Equipment
(
PPE)"

"
Some
materials
that
are
chemical­
resistant
to
this
product
are
[
registrant
inserts
correct
material(
s)]."

For
more
options,
follow
the
instructions
for
category
[
insert
A,
B,
C,
D,
E,
F,
G
or
H]
on
the
chemicalresistance
category
selection
chart
in
the
EPA
Label
Review
Manual,
3rd
Edition
(
EPA­
735­
B­
03­
001,

August
2003).

"
Mixers
and
loaders
using
liquid
formulations
must
wear:

­
long­
sleeved
shirt
and
long
pants,

­
shoes
and
socks,
and
­
chemical­
resistant
gloves."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
Engineering
Controls
For
all
formulations
labeled
for
use
on
agricultural
or
ornamental
crops,
aerial
applicators
must
use
enclosed
cockpits.
Enclosed
Cockpits
"
Pilots
must
use
an
enclosed
cockpit
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
agricultural
pesticides
[
40
CFR
170.240(
d)(
6)]."
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
84
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
Engineering
Controls:

Wettable
Powder
formulations
must
be
packaged
in
water
soluble
packaging
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
watersoluble
packets
must:

­
wear
the
personal
protective
equipment
required
in
the
PPE
section
of
this
labeling
for
mixers
and
loaders
­
be
provided,
and
must
have
immediately
available
for
use
in
an
emergency,
such
as
a
broken
package,
spill,
or
equipment
breakdown,
chemical­
resistant
gloves,
chemical­
resistant
footwear,

and
a
PF
5
dust­
mist
respirator."
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
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
or
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
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
(
Must
be
placed
in
a
box.)

Environmental
Hazards
Statements
"
ENVIRONMENTAL
HAZARDS"

For
end
use
products
containing
directions
for
use
on
agricultural
crops
and
ornamentals:
"
This
product
is
toxic
to
fish
and
shrimp.
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present,
or
to
inter­
tidal
areas
below
the
mean
high
water
mark.
Do
not
contaminate
water
when
cleaning
equipment
or
disposing
of
equipment
washwater
or
rinsate."

For
end­
use
products
intended
for
use
as
either
a
material
preservative
or
wood
preservative:
"
This
product
is
toxic
to
fish
and
shrimp.
Do
not
apply
directly
to
water.
Do
not
contaminate
water
when
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
85
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
disposing
of
equipment
wastewaters.
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
Eliminations
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
Environmental
Protection
Agency."

Restricted­
Entry
Interval
For
products
labeled
for
use
on
agricultural
or
ornamental
crops.
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI)
of
12
hours."
Directions
for
Use,
in
Agricultural
Use
Requirements
box
Early
Reentry
Personal
Protective
Equipment
For
Products
Subject
to
WPS
as
required
by
Supplement
3
of
PR
Notice
93­
7
"
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
soil
or
water,
is
­
coveralls,

­
shoes
and
socks,
and
­
chemical­
resistant
gloves
made
of
any
waterproof
material."
Directions
for
Use,
in
Agricultural
Use
Requirements
Box
General
Application
Restrictions
"
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
Application
Restrictions
For
products
labeled
for
use
as
material
preservatives
"
Do
not
apply
more
than
[
Registrant,
insert
amount
equal
to
0.125%
by
weight]
per
gallon
as
a
preservative
for
paints
and
stains."
Directions
for
Use
Use
Restrictions
For
products
labeled
for
use
on
agricultural
or
ornamental
crops
Do
not
harvest
rice
until
45
days
after
last
application
of
propiconazole.
The
preharvest
interval
(
PHI)
for
rice
is
45
days.

Note:
The
maximum
allowable
application
rate
and
maximum
allowable
rate
per
year
must
be
listed
as
pounds
or
gallons
of
formulated
product
per
acre,
not
just
as
lbs
ai/
A.
Directions
for
Use
86
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
Spray
Drift
Label
Language
for
Products
Applied
as
a
Spray
"
Spray
Drift
Management"

"
A
variety
of
factors
including
weather
conditions
(
e.
g.,
wind
direction,
wind
speed,
temperature,
relative
humidity)
and
method
of
application
can
influence
pesticide
drift.
The
applicator
must
evaluate
all
factors
and
make
appropriate
adjustments
when
applying
this
product."

Wind
Speed
"
Do
not
apply
at
wind
speeds
greater
than
15
mph."

Droplet
Size
"
Apply
as
a
medium
or
coarser
spray
(
ASAE
Standard
572)"

Temperature
Inversions
"
If
applying
at
wind
speeds
less
than
3
mph,
the
applicator
must
determine
if
a)
conditions
of
temperature
inversion
exist,
or
b)
stable
atmospheric
conditions
exist
at
or
below
nozzle
height.
Do
not
make
applications
into
areas
of
temperature
inversions
or
stable
atmospheric
conditions."

Other
State
and
Local
Requirements
"
Applicators
must
follow
all
state
and
local
pesticide
drift
requirements
regarding
application
of
propiconazole.
Where
states
have
more
stringent
regulations,
they
must
be
observed."

Equipment
"
All
application
equipment
must
be
properly
maintained
and
calibrated
using
appropriate
carriers
or
surrogates."

Additional
requirements
for
aerial
applications:

1.
"
The
boom
length
must
not
exceed
75%
of
the
wingspan
or
90%
of
the
rotor
blade
diameter."

2.
"
Release
spray
at
the
lowest
height
consistent
with
efficacy
and
flight
safety.
Do
not
release
spray
at
a
height
greater
than
10
feet
above
the
crop
canopy
unless
a
greater
height
is
required
for
aircraft
safety."

3.
"
When
applications
are
made
with
a
crosswind,
the
swath
must
be
displaced
downwind.
The
applicator
must
compensate
for
this
displacement
at
the
up
and
downwind
edge
of
the
application
area
by
adjusting
the
path
of
the
aircraft
upwind."
Directions
for
Use
under
General
Precautions
or
Restrictions
and/
or
Application
Instructions
87
Table
31.
Summary
of
Labeling
Changes
for
Propiconazole
Description
Amended
Labeling
Language
Placement
on
Label
Additional
requirement
for
groundboom
application:

1.
"
Do
not
apply
with
a
nozzle
height
greater
than
4
feet
above
the
crop
canopy."

End
Use
Products
Primarily
Used
by
Consumers/
Homeowners
Environmental
Hazards
Statement
"
ENVIRONMENTAL
HAZARDS"

"
This
product
is
toxic
to
fish
and
shrimp.
Do
not
apply
directly
to
water.
Do
not
contaminate
water
when
cleaning
equipment
or
disposing
of
equipment
washwaters
or
rinsate."
"
Drift
and
runoff
may
be
hazardous
to
aquatic
organisms
in
water
adjacent
to
treated
areas."
Precautionary
Statements
under
Environmental
Hazards
Entry
Restrictions
Products
applied
as
a
spray:

"
Do
not
allow
adults,
children,
or
pets
to
enter
the
treated
area
until
sprays
have
dried."

Products
applied
dry:

"
Do
not
allow
adults,
children,
or
pets
to
enter
the
treated
area
until
dusts
have
settled."
Directions
for
use
under
General
Precautions
and
Restrictions
General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
adults,
children,
or
pets,
either
directly
or
through
drift."
Place
in
the
Direction
for
Use
*
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.
In
the
case
of
multiple
active
ingredients,
the
more
protective
PPE
must
be
placed
on
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.
88
VI.
APPENDICES
APPENDIX
A1.
Propiconazole
Food/
Feed
Use
Patterns
Eligible
for
Reregistration
(
Case
3125)

Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Bananas
and
Plantains
Preharvest
foliar
Ground
Airblast,

highpressure
handwand,

backpack
sprayer
41.8%
EC
[
PR­
040005]
0.086
8
for
mist
sprayer
4
for
all
other
application
methods
0.675
21
N/
A
Apply
before
disease
symptoms
appear
at
the
onset
of
the
rainy
season.
Applications
should
be
made
using
orchard
oil
and
an
emulsifier.
Do
not
apply
within
100
yards
of
non­
bagged
bananas
or
directly
to
nonbagged
bananas.

Celery
Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
617]

[
100­
737]

45%
WP
[
100­
780]
0.1125
4
0.45
7
14
Foliar
Aerial,
ground,

and
sprinkler
irrigation
Quilt
®

11.7%
ai
[
100­
1178]
0.1138
4
0.45
7
7
89
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Cereals
(
Including
Wheat,
Barley,
Triticale,
and
Rye)

Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
617]

[
100­
737]

45%
WP
[
100­
780]
0.1125
2
0.167
NS
For
barley,
oats,
ryle,
and
triticales,
apply
to
the
emerging
flag
leaf;
but
do
not
apply
after
the
ligule
of
the
flag
leaf
emerges
(
Feekes
growth
stage
9).
For
wheat
only,
apply
until
full
head
emergence
(
Feekes
growth
stage
10.5).

Corn
(
Including
Field
Corn,
Field
Corn
Grown
for
Seed,
Sweet
Corn,
and
Popcorn)

Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
617]

[
100­
737]

45%
WP
[
100­
780]
0.1125
2
0.45
7
14
(
sweet
corn)
Start
treatment
when
disease
appears
and
repeated
on
a
7­
to
14­
day
schedule.
Do
not
apply
to
field
corn
or
field
corn
grown
for
seed
after
silking.
Do
not
harvest
forage
from
field
corn,

field
corn
grown
for
seed,
and
popcorn
within
30
days
of
application.
Do
not
harvest
sweet
corn
forage
within
14
days
of
application.

Preharvest
foliar
Ground
or
aerial
(
post
silk)
41.8%
EC
[
LA­
020003]

[
KS­
030002]

[
MN­
990014]

[
NE­
990006]

[
IL­
040004]
0.1125
2
0.45
7
14
(
sweet
corn)

30
(
seed,
field,

and
popcorn)
Treatment
should
be
started
when
disease
appears
and
repeated
on
a
7­
to
14­
day
schedule.
Do
not
feed
livestock
treated
forage
or
fodder
and
harvest
of
sweet
corn
forage
within
14
days
of
application
are
prohibited.
90
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Between
V4
to
after
silking
Stratego
®

11.4%
ai
[
264­
779]
0.1125
2
0.29
7
30
(
forage)

before
silking
Corn
Grown
for
Seed
(
See
Also
"
Corn")

Preharvest
foliar
Ground
or
aerial,

and
sprinkler
irrigation
41.8%
EC
[
100­
617]

[
IN­
990003]
0.1125
2
0.45
7
30
Treatment
should
be
started
when
disease
appears
and
repeated
on
a
7­
to
14­
day
schedule.
Making
more
than
two
applications
after
50%
silk
and
feeding
livestock
treated
forage
or
fodder
are
prohibited.

Applications
should
be
made
in
a
minimum
of
10
(
ground)
or
5
(
aerial)
gal
of
water/
A.

Preharvest
Aerial,

ground,
and
sprinkler
irrigation
41.8%
EC
0.1125
2
0.45
7
7
When
disease
first
appears.
91
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Grasses
Grown
for
Seed
Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
617]

[
100­
737]

45%
WP
[
100­
780]
0.225
(
0.1125­
bluegrass)
4
0.9
14
20
Use
is
limited
to
ID,
MN,
NE,

OR,
and
WA.
Apply
multiple
treatments
on
a
14­
to
21­
day
schedule.
The
feeding
of
treated
hay
is
prohibited
within
20
days
of
the
last
application,

and
the
grazing
of
treated
areas
is
prohibited
within
140
days.

Applications
should
be
made
in
a
minimum
of
20
(
ground)
or
10
(
aerial)
gal
of
water/
A.

Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
ID­
950012]

[
OR­
050012]

[
WA­
950033]

[
IN­
990003]

[
NV­
010004]

[
MT­
030004]
0.225
2
0.45
14
20
Apply
just
prior
to
anthesis.

Make
second
application
7­
10
days
later.
Should
be
tank
mixed
with
an
appropriate
surfactant.
The
feeding
of
treated
hay
is
prohibited
within
20
days
of
the
last
application,

and
the
grazing
of
treated
areas
is
prohibited
within
140
days.

Applications
should
be
made
in
a
minimum
of
20
(
ground)
or
10
(
aerial)
gal
of
water/
A.
92
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Mint
Preharvest
foliar
Ground
41.8%
EC
[
OR­
050011]
0.1125
2
0.225
10
90
Apply
when
plants
are
2­
4"

high.
Make
second
application
10­
14
days
later.
Applications
should
be
made
in
a
minimum
of
20
gal
of
water/
A.

Nectarines
(
See
"
Stone
fruits")

Oats
Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
617]
0.1125
1
0.1125
N/
A
40
Highest
yields
when
applied
to
the
emerging
flag
leaf;
do
not
apply
after
the
ligule
of
the
flag
leaf
emerges
(
Feekes
growth
stage
8).
Applications
should
be
made
in
a
minimum
of
10
(
ground)
or
5
(
aerial)
gal
of
water/
A.

Peaches
(
See
"
Stone
fruits")

Peanuts
Preharvest
foliar
Chemigation
or
directed
ground
41.8%
EC
[
100­
617]

45%
WP
[
100­
780]
0.225
2
0.45
14
21
Apply
to
crown
and
pegging
zones.
Begin
applications
45
or
60
days
after
planting
or
at
the
first
appearance
of
disease;

make
second
application
14
days
or
3­
4
weeks
later.

Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
617]

41.8%
EC
[
100­
737]

45%
WP
[
100­
780]
0.1125
4
0.45
10
14
Begin
applications
35­
40
days
after
planting
and
repeat
on
a
10­
to
14­
day
schedule.
93
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Preharvest
foliar
Ground
or
aerial
11.4%
ai
Stratego
®

[
264­
779]
0.1134
6
0.68
14
14
Pecans
Preharvest
foliar
Ground
or
aerial
Stratego
®

11.4%
ai
[
264­
779]

Tilt
®

41.8%
EC
[
100­
617]

Tilt
Bravo
SE
®

2.9
%
ai
[
100­
1192]
0.081
3
0.24
14
30
Apply
on
a
14­
day
schedule
during
bud
break,
prepollination
sprays,
or
during
nut
formation
and
cover
sprays.
Use
higher
rates
when
disease
pressure
is
heavier.
Do
not
apply
after
shuck
split.

Pineapple
Seed
Piece
Treatment
Postharvest
Cold
or
hot
water
dip
(
Seed
treatment)
45%
WP
[
100­
780]
0.1125
lb
ai/
500
gal
water
1
0.1125
lb
ai/
500
gal
water
N/
A
N/
A
Use
is
limited
to
Hawaii;

immerse
or
soak
crowns
(
seed
pieces)
for
control
of
disease.

Plantains
(
See
"
Bananas
and
Plantains")

Plums
(
See
"
Stone
fruits")
94
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Rice
Preharvest
foliar
Aerial
41.8%
EC
[
100­
617]

[
100­
737]

Stratego
®
11.4%

ai
[
264­
779]
0.2813
or
0.16
2@
0.1688
lb
ai/
A
or
1@
0.2813
lb
ai/
A
0.34
10
35
If
 
5%
of
tillers
are
infected,
2
appls.
should
be
made,
one
at
1rst
internode
elongation
(
up
to
2­
inch
panicle)
and
one
at
swollen
boot
(
10­
14
days
after
1rst
appl.
but
before
the
boot
splits
and
head
emerges).
If
>
10%
of
tillers
are
infected,
the
higher
single
application
rate
should
be
made
at
first
internode
elongation.
Do
not
use
in
California.
In
Arkansas,

do
not
use
in
areas
of
the
following
counties:

Mississippi,
Poinsett,
Cross,
St.

Francis,
and
Lee.
Do
not
use
in
rice
fields
where
crayfish
are
commercially
farmed.
Do
not
drain
water
from
treated
rice
fields
into
ponds
used
for
commercial
catfish
farming.

Do
not
apply
to
stubble
or
ratoon
crop
rice.
Do
not
use
water
drained
from
treated
fields
to
irrigate
other
crops.

Wild
Rice
Preharvest
foliar
Aerial
41.8%
EC
[
100­
617]

[
100­
737]

45%
WP
[
100­
780]
0.225
2@
0.1688
lb
ai/
A
or
1@
0.225
lb
ai/
A
0.34
10
NS
Use
is
limited
to
Minnesota.

Apply
at
lower
rate
at
both
booting
and
heading,
OR
make
one
application
at
the
higher
rate
at
booting.
Do
not
use
water
from
treated
fields
to
95
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
irrigate
other
crops.

Rye
(
See
"
Cereals")

Stone
Fruits
(
Sweet
or
tart
Cherry,
Apricots,
Nectarines,
Peaches,
and
Plums
or
Prune)

Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
100­
702]

45%
WP
[
100­
781]
0.1125
2
0.225
10
Two
applications
may
be
made
during
the
period
beginning
10­

14
days
before
harvest
through
the
day
of
harvest.

Alternatively,
the
first
application
may
be
made
at
early
bloom
stage
and
the
second
application
may
be
made
as
needed
through
petal
fall.

Sugarcane
Seed
Piece
Treatment
Postharvest
Cold
or
hot
water
dip
45%
WP
[
100­
780]
0.1125
lb
ai/
500
gal
water
1
0.1125
lb
ai/
500
gal
water
N/
A
N/
A
Use
is
limited
to
Hawaii.

Immerse
or
soak
cut
seed
pieces
for
control
of
disease.

Sunflower
(
Breeder's
seed)

Foliar
spray
41.8%
EC
[
IL­
050002]

[
TX­
000006]
0.1125
4
0.45
7
N/
A
Apply
foliar
spray,
when
disease
first
appears.
96
Application
Type
Application
Equipment
Formulation
1
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Apps.
per
Season
Maximum
Seasonal
Rate
(
lb
ai/
A)
Minimum
Application
Interval
(
days)
Preharvest
Interval
(
PHI)

(
days)
Use
Directions
and
Limitations
2
Wheat
(
See
also
"
Cereals")

Preharvest
foliar
Ground
or
aerial
41.8%
EC
[
GA­
980003]

[
IN­
980003]

[
MI­
980001]

[
MN­
980003]

[
MS­
980004]

[
VA­
980003]

[
WA­
980018]

[
AR­
030008]

[
MO­
980003]

[
KS­
030001]

[
TN­
030002]

[
OH­
040002]

[
KY­
050002]
0.1125
1
0.1125
N/
A
40
Apply
to
the
emerging
flag
leaf.

Do
not
apply
after
full
head
emergence
(
Feekes
growth
stage
10.5).

1
The
41.8%
EC
formulations
have
been
determined
to
contain
3.6
lb
ai/
gal
of
propiconazole
based
on
historical
data.

2
Propiconazole
may
be
tank
mixed
with
other
fungicides;
however
labels
for
EPA
Reg.
Nos.
100­
702
and
100­
781
state
that
tank
mixing
with
Cyprex
®
may
cause
crop
injury.

Note:
The
41.8%
EC
[
EPA
Reg.
Nos.
100­
617
and
100­
737]
and
the
45%
WP
[
EPA
Reg.
No.
100­
780]
are
the
only
products
currently
registered
for
use
on
rotatable
crops.
The
labels
for
these
formulations
state
that
soybeans
may
be
planted
as
a
double
crop
following
a
cereal
crop
which
has
been
treated
with
the
product,
but
soybean
hay,
forage,
and
fodder
may
not
be
used
as
any
component
of
animal
feed
or
bedding.
The
labels
specify
that
any
food/
feed
crops
not
listed
on
the
label
should
not
be
planted
within
105
days
of
treatment.
97
APPENDIX
A2:
Maximum
Rates
and
Applications
for
Nonfood
Uses
of
Propiconazole
Eligible
for
Reregistration
Application
Type
and/
or
Timing
Application
Equipment
Typical
Formulation
[
EPA
Reg.
No.]
Maximum
Application
Rate
Maximum
Number
of
Applications
Per
Crop
Cycle
Maximum
Annual
Application
Rate
(
lb
ai/
A/
year)
Minimum
Retreatment
Interval
NONBEARING
FRUIT
AND
NUT
TREES
Non­
bearing
Apple
Foliar
Hose­
end
and
pump­
up
sprayer
Alamo
®
14.3%
ai
[
100­
741]

Tilt
41.8
%
EC
[
100­
617]
0.08
lb
ai/
A
Not
Specified
7.2
lb
ai/
A/
year
14
days
Non­
bearing
Nectarine,
Peach
Plum,
Cherry
Foliar
Hose­
end
and
pump­
up
sprayer
Tilt
®
41.8%
EC
[
100­
617]
0.04
lb
ai/
100
gal
Not
Specified
7.2
lb
ai/
A/
year
14
days
Non­
bearing
Pecan
Non­
bearing
Aerial,
ground,
hose­
end
and
pump­
up
sprayer
Tilt
®
41.8%
EC
[
100­
617]
0.12
lb
ai/
100
gal
3
7.2
lb
ai/
A/
yr
14
days
Non­
bearing
Citrus
June,
July,
August
Aerial,
ground,
hose­
end
and
pump­
up
sprayer
Orbit
®

41.8%
EC
[
100­
702]

Banner
GL
®

41.8%
EC
[
100­
736]
0.225
lb
ai/
A
Not
Specified
7.2
lb
ai/
A/
yr
14
days
Non­
bearing
Walnut
Foliar
Spray
Tilt
®
41.8%
EC
[
100­
617]
0.08
lb
ai/
100
gal.
Not
Specified
7.2
lb
ai/
A/
yr
14
days
98
Application
Type
and/
or
Timing
Application
Equipment
Typical
Formulation
[
EPA
Reg.
No.]
Maximum
Application
Rate
Maximum
Number
of
Applications
Per
Crop
Cycle
Maximum
Annual
Application
Rate
(
lb
ai/
A/
year)
Minimum
Retreatment
Interval
TURF
AND
ORNAMENTALS
Ground
Cover
Foliar
Hose­
end
and
pump­
up
sprayer
Banner
GL
®

41.8%
EC
[
100­
736]
0.7524
lb
ai/
A
Not
Specified
37
packets
14
days
Lawns,
Turf,
and
Golf
Courses
Foliar
Hose­
end
and
pump­
up
sprayer
Ground
boom
sprayer
Banner
GL
®

41.8%
EC
[
100­
736]

Tilt
®
41.8%
EC
[
100­
617]
1.79
lb
ai/
A
Not
Specified
7.2
lb
ai/
A/
yr
14
days
Industrial/
Commercial
Lawns
and
Turf
When
needed
Ground
spray
Banner
GL
®

41.8%
ai
[
100­
736]

Tilt
Bravo
®
SE
2.9%
[
100­
1192]
0.02
lb/
1K
sq.
ft.
2
Not
Specified
14
days
Shade
Trees
(
injection)

Root
Injection
Alamo
®

14.3%
liquid
[
100­
741]
0.0069
lb
ai/
DBH
1
Not
Specified
Not
Applicable
Shade
Trees
(
outdoor
spray),
Herbaceous
Plants,
Ornamental
Woody
Shrubs
and
Vines
Hose­
end
and
pump­
up
sprayer
Banner
GL
®

41.8%
ai
[
100­
736]

Tilt
®
41.8%
EC
[
100­
617]
0.24
lb
ai/
100
gal
Not
Specified
7.2
lb
ai/
A/
yr
Not
Specified
Sod
Farm
Turf
Ground
bloom
Sprayer
Alamo
®
1.79
lb
ai/
A
Not
Specified
7.2
lb
ai/
A/
yr
7
99
Application
Type
and/
or
Timing
Application
Equipment
Typical
Formulation
[
EPA
Reg.
No.]
Maximum
Application
Rate
Maximum
Number
of
Applications
Per
Crop
Cycle
Maximum
Annual
Application
Rate
(
lb
ai/
A/
year)
Minimum
Retreatment
Interval
14.3%
ai
liquid
[
100­
741]

Banner
GL
41.8%
ai
[
100­
736]

Tilt
®
41.8%
EC
[
100­
617]
Non­
bearing
Blueberries
Non­
bearing
Spray
41.8%
EC
[
FL­
940005]
0.169
lb
ai/
A
5
0.85
lb
ai/
A/
yr
28
days
(
June­
October)

Non­
bearing
Hazelnuts
At
emergence
Aerial
and
ground
41.8%
EC
[
OR­
040003]
0.225
lb
ai/
A
No
more
than
32
oz
of
Orbit
®
/
A/
season
0.90
14
days
Note:
PPZ
1.55%
HG
[
EPA
Reg.
No.
100­
773]
and
PPZ
1.55%
Multi­
purpose
fungicide
[
Reg.
No.
100­
952]
are
also
used
in
residential
consumer
market.
These
labels
have
lower
application
rates
than
Alamo/
Banner
MAXX
[
EPA
Reg
No.
100­
741].
100
APPENDIX
A3
Propiconazole
Antimicrobial
Uses
Eligible
for
Reregistration
Use
Site
Typical
Formulation
[
EPA
Reg.
No.]

%
ai
Maximum
Application
Rate
Maximum
Number
of
Applications/

Minimum
Retreatment
Interval
Use
Directions
and
Limitations
Application
Method
from
Labels
Antimicrobial
Uses
 
Material
Preservative
50%
SL
[
43813­
37]

9.7%
ai
[
43813­
19]
1.213%
ai
by
weight
of
material
NS
For
Commercial
or
Industrial
Use
Only
7%
Liquid
Concentrate
[
5383­
114]
0.125­
5.0%
NS
For
Commerical
or
Industrial
Use
Only
8%
Liquid
[
1448­
394]
0.6
­
10
%
NS
Adhesives,
coatings,
caulks,

sealants,
and
inks
23.6%
EC
[
43813­
16]
0.2
 
5%
based
on
total
weight
of
material
NS
For
Commercial
or
Industrial
Use
Only
Do
not
use
on
products
that
will
contact
food
50%
SL
[
43813­
37]
0.1­
2.4%
based
on
total
weight
of
material
NS
For
Commercial
or
Industrial
Use
Only
Industrial
Coatings,
Industrial
Specialty
Industrial
Products
7%
Liquid
Concentrate
[
5383­
114]
0.125­
5%
For
Commercial
or
Industrial
Use
Only
Material
Preservative
for
Paints
and
Stains
10%
Liquid
Concentrate
[
5383­
114]
0.125
%
ai
by
weight
of
material
to
be
preserved
For
Commercial
or
Industrial
Use
Only
Leather
Processing,
Material
Preservative
for
Leather
Finishing
Pastes
etc
4.5%
ai
[
71406­
1]

[
70227­
6]
0.05
to
0.4%
by
weight
of
tanned
leather
;
0.01
to
0.25%
by
weight
of
leather
finishing
pastes,
fatliquors,

or
finishes
NS
For
Commercial
or
Industrial
Use
Only
Add
to
tanning
solution
or
finishing
solution
OR
Add
to
leather
finishing
pastes,

fatliquors,
or
finish
23.6%
EC
[
43813­
16]
50
­
700
ppm
ai
in
diluted
fluid
NS
For
Commercial
or
Industrial
Use
Only
Metal
working/
Cutting
Fluids
50%
SL
[
43813­
37]
50­
700
ppm
ai
in
diluted
fluid
Not
Specified
For
Commercial
or
Industrial
Use
Only
Added
to
Metalworking
Fluids
using
Liquid
Pump
or
Liquid
Pour
101
Use
Site
Typical
Formulation
[
EPA
Reg.
No.]

%
ai
Maximum
Application
Rate
Maximum
Number
of
Applications/

Minimum
Retreatment
Interval
Use
Directions
and
Limitations
Application
Method
from
Labels
7%
ai
[
5383­
114]
0.5­
2.5
Not
Specified
50%
SL[

43813­
37]
0.28%
ai
by
weight
of
material
to
be
preserved
Not
Specified
23.6%
EC
[
43813­
16]
2000
ppm
ai
in
treatment
solution
Not
Specified
Dye
Incorporation,
Pad,

Exhaust,
or
Spray
Application
Textiles/
Canvas
50%
SL
[
43813­
37]
2000
ppm
in
treatment
solution
(
0.4%
product)
Not
Specified
Not
for
use
on
carpet
fibers,

home
furnishings
(
except
shower
curtains),
or
apparel
Dye
Incorporation,
Pad,

Exhaust,
or
Spray
Application
Antimicrobial
Uses
 
Wood
Preservative
Wood
in
Commercial/
Industrial
Water
Cooling
Systems
23.6%
EC
[
43813­
16]
0.5
 
1.1%
ai
solution
(
0.23
 
0.46
lbs
ai/
1000
sq.
ft
wood
When
Needed,
Repeat
Shock
Treatement
every
4­
6
months
Not
Specified
High
volume
spray
Mushroom
Houses­
Empty
Premises/
Equipment
23.6%
EC
[
43813­
15]

[
43813­
16]
0.31
lb/
25
gal
0.06
lb/
1000
sq.
ft.

0.0125
lb
ai/
gal;
1
gal/
200
sq
ft
wood
13
week
application
interval
For
spray
treatment,
apply
25
gallons
of
treatment
solution
per
5000
square
feet
of
surface
For
dip
treatment,
submerge
trays
or
boards
for
no
more
than
30
seconds
Spray
and
dip
tank
Wood
Protection
Treatment
to
Buildings
(
Indoor)
30
l
cu.
m
(
L)
Typically
1
Not
Specified
Conventional
or
electrostatic
spray
and
dip
tank
Wood
Protection
Treatment
to
Buildings
(
Outdoor)
0.3532
lb
ai/
iK
sq.
ft.
Typically
1
Not
Specified
Conventional
or
electrostatic
spray
and
dip
tank
Wood
Protection
Treatment
to
Forest
Products
(
Seasoned)
6.8
lb/
90
gal
Typically
1
Not
Specified
Pressure
treatment
(
double
vacuum,
full­
cell
or
modified
full­
cell)
and
brush
applied
Wood
Protection
Treatment
to
Forest
Products
(
Unseasoned)
23.6%
EC
[
43813­
16]

9.7%
SL
[
43813­
19]

[
75506­
3]

20%
ai
[
70227­
4]

50%
ai
[
43813­
21]

[
43813­
37]
41.7
lb/
90
gal
Typically
1
Not
Specified
102
Use
Site
Typical
Formulation
[
EPA
Reg.
No.]

%
ai
Maximum
Application
Rate
Maximum
Number
of
Applications/

Minimum
Retreatment
Interval
Use
Directions
and
Limitations
Application
Method
from
Labels
Non­
pressure
Treatment
of
Wood
&
Wood
Products
1%
Liquid
Readyto
Use
[
1448­
414]
0.02%
ai
solution
(
0.5
to
2.0
gallons
per
100
gallons
of
water)
Not
Specified
Not
Specified
Immersion,
Dip
treatment,

Conventional
Spray,

Electrostatic
Spray
3%
Liquid
[
1022­
585]
0.06
%
ai
solution
(
1
gallon
per
50
to
75
gallons
of
dip
vat
solution)
Not
Specified
For
Commerical
or
Industrial
Use
Only
Immersion,
Dip
Treatment
3.5%
Liquid
[
60061­
112]
For
high­
pressure
spray
application,
mix
1
gallon
per
2
to
500
gallons
water
For
dip
application,
mix
1
gallon
per
20
to
1,000
gallons
water
Not
Specified
For
Commercial
or
Industrial
Use
Only
Immersion,
Dip
Treatment,

High­
pressure
Application
4.5%
Liquid
[
71406­
1]

[
70227­
6]

[
60061­
114]
Deposit
rate
of
0­
20
ug
ai/
cm
2
wood
surface
Not
Specified
For
Commercial
or
Industrial
Use
Only
Bulk
Dip
Tanks,
Conventional
Spray
Systems,
Low
volume
spray
systems
5%
Liquid
[
72616­
1]

[
60061­
107]
0.1­
0.2%
ai
solution
(
1
gallon
with
25­
300
gallons
of
water)
Not
Specified
For
Commercial
or
Industrial
Use
Only
Dip
Tank,
Immersion,

Conventional
Spray,
High­

Pressure
Spray
Anti­
Sapstain
50%
SL
[
43813­
37]
0.5­
1.0%
ai
solution
Not
Specified
For
Commercial
or
Industrial
Use
Only
Immersion,
roller
coater,

flood,
spray,
brush
treatment
7%
Liquid
Concentrate
[
5383­
114]
0.5
to
5%
ai
solution
Not
Specified
For
Comemrcial
or
Industrial
Use
Only
Dip
Tank,
Immersion,

Conventional
Spray,
High­

Pressure
Spray
8%
Liquid
Concentrate
[
1448­
394]
0.5­
5%
ai
solution
Not
Specified
For
Commercial
or
Industrial
Use
Only
Dip
Tanks,
Conventional
Spray
Systems
9.7%
Liquid
Concentrate
[
43813­
19]
0.5
­
1%
ai
solution
Not
Specified
Not
Specified
Immersion,
Roller
Coater,

Flood
Spray,
Brush
Anti­
Saptain
10%
Liquid
0.04
to
1.7%
ai
solution
Not
Specified
For
Commercial
or
Industrial
Dip
Tanks,
Conventional
103
Use
Site
Typical
Formulation
[
EPA
Reg.
No.]

%
ai
Maximum
Application
Rate
Maximum
Number
of
Applications/

Minimum
Retreatment
Interval
Use
Directions
and
Limitations
Application
Method
from
Labels
Concentrate
[
60061­
102]
(
1
gallon
with
50
to
2000
gallons
water)
Use
Only
Spray
Systems
Anti­
Sapstain
for
fresh
sawn
lumber
20%
Liquid
Concentrate
[
70227­
4]
0.05
 
0.5%
ai
solution
Not
Specified
Not
Specified
Dip
Tank,
Spray
Box
9.7%
Liquid
Concentrate
[
43813­
19]

[
62190­
17]
0.5%­
5%
ai
solution
Not
Specified
For
Commercial
or
Industrial
Use
Only
Immersion,
Roller
Coater,

Flood
Spray,
Brush
onventional
Spray,

Electrostatic
Spray
0.1%
Liquid
Readyto
Use
[
60061­
109]
0.1%
Ready­
to
Use,
5
to
10
gallons
per
1000
board
feet
for
diptank;
1
gallon
per
200
square
feet
for
brush
application
Not
Specified
For
Commercial
or
Industrial
Use
Only
Diptank
or
Brush
Application
Wood
preservative/
Decay
Control
[
60061­
115]

0.997%
ai
Dilute
one
part
product
with
4
parts
petroleum
solvent
Not
Specified
Dilute
one
part
product
with
1.5
to
4
parts
petroleum
solvent
Immersion,
pressure
treatment
23.6%
EC
[
43813­
16]
0.5
 
1
%
ai
solution
Not
Specified
For
Cmmercial
or
Industrial
Use
Only
Do
not
use
on
wood
that
will
contact
food
Immersion,
roller
coating,
or
flood
coating
Wood
Preservative
50%
SL
[
43813­
37]
0.5­
1.0%
ai
solution
Not
Specified
For
Commerical
or
Industrial
Use
Only
Immersion,
roller
coater,

flood,
spray,
brush,
or
pressure
treatment
Pressure
Treatment
of
Wood
Wood
preservative
0.4%
ai
[
62190­
12]
0.5
to
7%
aqueous
solution
by
weight
Not
Specified
For
Commercial
or
Industrial
Use
Only
Use
only
in
vacuum
pressure
impregnation
systems
0.5%
Liquid
Readyto
Use
[
75101­
1]
30
L/
meter
3
Not
Specified
Wood
must
be
clean
and
dry
before
treatment.
Pressure
treatment
(
double
vacuum
process)

Wood
Preservative
 

machined
and
manufactured
wood
products
0.997%
ai
Liquid
[
60061­
115]
0.5
%
ai
solution
Not
Specified
Dilute
product
with
petroleum
solvent
Immersion,
pressure
treatment
104
Use
Site
Typical
Formulation
[
EPA
Reg.
No.]

%
ai
Maximum
Application
Rate
Maximum
Number
of
Applications/

Minimum
Retreatment
Interval
Use
Directions
and
Limitations
Application
Method
from
Labels
Wood
preservative
50%
SL
[
43813­
37]
0.5­
1.0%
ai
solution
Not
Specified
For
Commercial
or
Industrial
Use
Only
Double
vacuum,
full
cell,
or
modified
full
cell
pressure
treatment
105
APPENDIX
B:
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Propiconazole
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

PRODUCT
CHEMISTRY
830.1550
61­
1
Product
Identity
and
Composition
All
40583701,
43764401
830.1600
61­
2A
Start.
Mat.
&
Mnfg.
Process
All
40583701,
43420701
830.1670
61­
2B
Formation
of
Impurities
All
40583701,
43764401
830.1700
62­
1
Preliminary
Analysis
All
40583702,
43764402
830.1750
62­
2
Certification
of
limits
All
40583702,
43764401
830.1800
62­
3
Analytical
Method
All
40583702,
43764402
830.6302
63­
2
Color
All
40583703,
42030201,

43698701
830.6303
63­
3
Physical
State
All
40583703,
42030201,

43698701
830.6304
63­
4
Odor
All
40583703,
42030201,

43698701
830.7220
63­
6
Boiling
Point
All
40583703,
42030201,

43698701
830.7300
63­
7
Density
All
40583703,
42030201,

43698701
830.7840
830.7860
63­
8
Solubility
All
40583703,
42030201
830.7950
63­
9
Vapor
Pressure
All
40583703,
42030201
830.7370
63­
10
Dissociation
Constant
All
40583703,
42030201,

43698701
830.7550
63­
11
Octanol/
Water
Partition
Coefficient
All
42030201,
43698701
830.7000
63­
12
pH
All
42030201,
43698701
830.6313
63­
13
Stability
All
43698701,
00067961
ECOLOGICAL
EFFECTS
850.2100
71­
1
Avian
Acute
Oral
Toxicity
00079689,
00067926
106
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

850.2200
71­
2A
Avian
Dietary
Toxicity
­
Quail
00072210,
00133366
850.2200
71­
2B
Avian
Dietary
Toxicity
­
Duck
00067927,
00072210,

00133367
850.2300
71­
4A
Avian
Reproduction
­
Quail
00133369
850.1075
72­
1A
Fish
Toxicity
Bluegill
0067922
850.1075
72­
1B
Fish
Toxicity
Bluegill
­
TEP
00132922,
00072209
850.1075
72­
1C
Fish
Toxicity
Rainbow
Trout
00067921
(
0072209),

0067923,
00132926
None
72­
3D
Fish
Toxicity
Rainbow
Trout
TEP
00132927
850.1010
72­
2A
Invertebrate
Toxicity
00067925,
00244273
850.1010
72­
2B
Invertebrate
Toxicity
­
TEP
00132932,
00072209
850.1075
72­
3A
Estuarine/
Marine
Toxicity
­
Fish
00132921
850.1025
72­
3B
Estuarine/
Marine
Toxicity
­
Mollusk
00260201
850.1035
850.1045
72­
3C
Estuarine/
Marine
Toxicity
­
Shrimp
00260201
None
72­
3D
Estuarine/
marine
Fish
Acute
Toxicity
Test
(
TEP)
00132924
None
72­
3E
Estuarine/
marine
Mollusk
(
Oyster)

Acute
Toxicity
Test
(
Shell
Deposition)

(
TEP)
00132933,
0072209
None
72­
3F
Estuarine/
marine
Mysid
(
Shrimp)
Acute
Toxicity
Test
(
TEP)
00132934,
0072209
850.1400
72­
4A
Fish­
Early
Life
Stage
00072210
850.1300
850.1350
72­
4B
Estuarine/
Marine
Invertebrate
Life
Cycle
Data
Gap
850.4225
123­
1A
Seed
Germ./
Seedling
Emergence
41673203
850.4250
123­
1B
Vegetative
Vigor
41673201
107
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

850.4400
123­
2
Aquatic
Plant
Growth
00132937,
00132938,

00132939,
00133362
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity­
Rat
00058591
870.1200
81­
2
Acute
Dermal
Toxicity­
Rabbit/
Rat
00058596
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
41594801
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
00058597
870.2500
81­
5
Primary
Skin
Irritation
00058598
870.2600
81­
6
Dermal
Sensitization
00058600
870.6200
81­
8
Acute
Neurotoxicity
Screen
 
Rats
46604601
870.3100
82­
1A
90­
Day
Feeding
­
Rodent
00058606,
42050501,

42050502,
45215801
870.3150
82­
1B
90­
Day
Feeding
­
Non­
rodent
00058607
870.3200
82­
2
21­
Day
Dermal
­
Rabbit/
Rat
00116591
870.4100
83­
1B
Chronic
Feeding
Toxicity
­
Non­
Rodent
00151515
870.4200
83­
2A
Oncogenicity
­
Rat
00129918
870.4200
83­
2B
Oncogenicity
­
Mouse
00129570,
44381401
870.3700
83­
3A
Developmental
Toxicity
­
Rat
40425001
870.3700
83­
3B
Developmental
Toxicity
­
Rabbit
40425004
870.3800
83­
4
2­
Generation
Reproduction
­
Rat
00151514
870.4100
83­
1A
Chronic
Dietary
­
Rodent
00129918
870.4100
83­
1B
Chronic
Dietary
 
Non­
rodent
00151515
870.5300
84­
2
In
Vitro
Cell
Transformation
00133349
870.5385
84­
2B
Structural
Chromosomal
Aberration
00058603
870.5450
84­
2
Rodent
Dominant
Lethal
Assay
00058602
108
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

870.5550
84­
2
Unscheduled
DNA
Synthesis
in
Mammalian
Cells
00133347,
00133348
870.5575
84­
2
Mitotic
Gene
Conversion
in
Saccharomyces
Cerevisiae
00133343
870.7485
85­
1
General
Metabolism
42403901,
41326701,

00074506,
00074507,

00164795
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.1100
231
Estimation
of
Dermal
Exposure,

Outdoor
Sites
45524304,
45469501,

ORTF#
OMA002,

ORTF#
OMA004,
New
Data
Requirement
(
Paint
Use)

875.1200
233
Estimation
of
Dermal
Exposure,
Indoor
Sites
45524304,
ORTF#

OMA004,
New
Data
Requirement
(
Paint,

Wood
Preservative
Uses)

875.1300
232
Estimation
of
Inhalation
Exposure,

Outdoor
Sites
45524304,
45469502,

New
Data
Requirement
(
Paint
Use)

875.1400
234
Estimation
of
Inhalation
Exposure,

Indoor
Sites
45524304,
46513901,

New
Data
Requirement
(
Paint,
Wood
Preservative
Uses)

875.1200
132­
1A
Foliar
(
Dislodgeable)
Residue
Dissipation
00133390,
42564003,

44959701,
44959702,

45288601
109
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
0067901,
0067911,

133409,
93194052
835.2240
161­
2
Photodegradation
­
Water
41811901,
0067911,

133409
835.2410
161­
3
Photodegradation
­
Soil
41811902,
0067911,

133409
835.4100
162­
1
Aerobic
Soil
Metabolism
00129912,
00129914,

00133375
835.4400
162­
3
Anaerobic
Aquatic
Metabolism
42415702
835.4300
162­
4
Aerobic
Aquatic
Metabolism
42347901
835.1240
163­
1
Leaching/
Adsorption/
Desorption
Data
Gap
(
MRIDs
41727001,
44701801
are
both
supplemental)

835.6100
164­
1
Terrestrial
Field
Dissipation
00155642,
00159691,

45528702,
45528703
835.6200
164­
2
Aquatic
Field
Dissipation
452560501,
452560502
RESIDUE
CHEMISTRY
860.1300
171­
4A
Nature
of
Residue
­
Plants
A,
B
00074496,
00074498
,

00074499,
00074500
,

00074501,
00074502,

00129915
,
00155645
,

44049601,
44381402,

93194062
110
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

860.1300
171­
4B
Nature
of
Residue
­
Livestock
A,
B
00067905,
00074503,

00074504,
41823301,

41823302,
41823304
,

42564006,
42983001,

93194085
860.1340
171­
4C
Residue
Analytical
Method
­
Plants
A,
B
00137150,
40154501,

40180701,
40692203,

40692204,
40692206,

40783306,
41063801,

41063802,
41486801,

41823305,
42061301,

42182901,
42564005,

42605801,
42634101,

43424601,
43434201,

43825401,
44411201,

44411206,
44411207,

44411208,
93194064
860.1340
171­
4D
Residue
Analytical
Method
­
Animals
A,
B
40150701,
40154501,

40180702,
41823304,

44411204,
93194067
860.1380
171­
4E
Storage
Stability
A,
B
00074510,
00074511,

00133385,
40692201,

41063801,
41063802,

41486802,
42605801,

43314201,
43825402,

44411205,
93194068,

40150701
,
42983001
860.1650
171­
13
Analytical
Reference
Standards
A,
B
Data
Gap
860.1480
171­
4J
Magnitude
of
Residues
­
Meat/
Milk/
Poultry/
Egg
111
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

­
Milk
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Cattle,
Goats,
Hogs,

Horses,
and
Sheep
A,
B
00137861,
40150701
,

93194070
­
Eggs
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Poultry
A,
B
00137861,
40150701
,

93194070
860.1500
171­
4K
Crop
Field
Trials
(
Stone
Fruits
Group)

­
Apricots
A,
B
41063802
­
Cherries
A,
B
43655609
­
Nectarines
A,
B
41063802
­
Peaches
A,
B
41063802
­
Plums
A,
B
41063802
­
Prunes,
fresh
A,
B
41063802
860.1500
171­
4K
Crop
Field
Trials
(
Tree
Nuts
Group)

­
Pecans
A,
B
00074495
,
00074508
,

00074509
,
00153327
860.1500
171­
4K
Crop
Field
Trials
(
Cerial
Grains
Group)

­
Barley,
grain
A,
B
93194072
­
Corn,
field,
grain
and
aspirated
grain
fractions
A,
B
40783303,
42564004,

42564005
­
Corn,
sweet
(
kernels
plus
cobs
with
husks
removed)
A,
B
40783303,
42564004,

42564005
­
Oats,
grain
A,
B
42182901,
43314202
­
Rice,
grain
A,
B
00137861,
42915601,

44411208,
93194075
­
Wheat,
grain
and
aspirated
grain
fractions
A,
B
44411206,
44411207,

93194072
­
Wild
rice
A,
B
41063801,
42511401
860.1500
171­
4K
Crop
Field
Trials
(
Fodder,
Forage,
Hay,
and
Straw
of
Cereal
Grains
Group)
112
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

­
Barley,
hay
and
straw
A,
B
93194072
­
Corn,
field,
forage
and
stover
A,
B
40783303,
42564004,

42564005
­
Corn,
sweet,
forage
and
stover
A,
B
40783303,
42564004,

42564005
­
Oats,
forage,
hay,
and
straw
A,
B
42182901,
43314202
­
Rice,
straw
A,
B
00137861,
44411208,

93194075
­
Wheat,
forage,
hay,
and
straw
A,
B
44411206,
44411207,

93194072
860.1500
171­
4K
Crop
Field
Trials
(
Grass
Forage,
Fodder,
and
Hay
Group)

­
Grass,
seed
screenings,
forage,

hay,
and
straw
A,
B
40890701,
41823305,

42634101,
42634102,

93194073
860.1500
171­
4K
Crop
Field
Trials
(
Miscellaneous
Commodities)

­
Bananas
A,
B
00137150,
93194071
­
Mint
A,
B
42061301,
43424601
­
Mushrooms
A,
B
43434201
­
Peanut,
nutmeat
and
hay
A,
B
40692201
­
Pineapple
A,
B
40783305
­
Sugarcane
A,
B
44142401,
93194077
860.1520
171­
4L
Magnitude
of
Residue
in
Processed
Food/
feed
­
Corn,
field
A,
B
40783303,
42564005
­
Mint
A,
B
42061301,
43424601
­
Oat
A,
B
42182901
­
Peanut
A,
B
40692201,
42605801
­
Pineapple
A,
B
40783305,
Data
Gap
113
Requirement
New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Citation(
s)

­
Plum
A,
B
41063802
­
Rice
A,
B
00137861,
42915601,

93194079
­
Wheat
A,
B
44411206,
44411207,

44757208,
93194080
835.1850
165­
1
Confined
Rotational
Crop
A,
B
00074498,
00129915,

00138266,
00155644,

00155645,
00164802,

41102001
860.1950
165­
4
Bioaccumulation
in
Fish
A,
B
44411206
OTHER
Non­
Guideline
Rat
developmental
Toxicicty
40425002
Non­
Guideline
Tumor
Promotion
 
rat
2000
ppm
dietary
up
to
8
weeks
00151517
Non­
Guideline
Mechanistic
studies:
Hepatic
Biochemical
Parameters
 
Male
CD­
1
mice
45215803
Non­
Guideline
Mechanistic
studies:
Hepatocellular
Proliferation
­
Mouse
45215802
Non­
Guideline
Catfish
Acute
Toxicity
00132930,
00067924,

00244273
114
Appendix
C:
Bibliography
of
Studies
Considered
in
the
Propiconazole
RED
GUIDE
TO
APPENDIX
C
1.
CONTENTS
OF
BIBLIOGRAPHY.
This
bibliography
contains
citations
of
all
studies
considered
relevant
by
EPA
in
arriving
at
the
positions
and
conclusions
stated
elsewhere
in
the
Reregistration
Eligibility
Document.
Primary
sources
for
studies
in
this
bibliography
have
been
the
body
of
data
submitted
to
EPA
and
its
predecessor
agencies
in
support
of
past
regulatory
decisions.

Selections
from
other
sources
including
the
published
literature,
in
those
instances
where
they
have
been
considered,
are
included.

2.
UNITS
OF
ENTRY.
The
unit
of
entry
in
this
bibliography
is
called
a
"
study".
In
the
case
of
published
materials,
this
corresponds
closely
to
an
article.
In
the
case
of
unpublished
materials
submitted
to
the
Agency,
the
Agency
has
sought
to
identify
documents
at
a
level
parallel
to
the
published
article
from
within
the
typically
larger
volumes
in
which
they
were
submitted.
The
resulting
"
studies"

generally
have
a
distinct
title
(
or
at
least
a
single
subject),
can
stand
alone
for
purposes
of
review
and
can
be
described
with
a
conventional
bibliographic
citation.
The
Agency
has
also
attempted
to
unite
basic
documents
and
commentaries
upon
them,
treating
them
as
a
single
study.

3.
IDENTIFICATION
OF
ENTRIES.
The
entries
in
this
bibliography
are
sorted
numerically
by
Master
Record
Identifier,
or
"
MRID
number".
This
number
is
unique
to
the
citation,
and
should
be
used
whenever
a
specific
reference
is
required.
It
is
not
related
to
the
six­
digit
"
Accession
Number"
which
has
been
used
to
identify
volumes
of
submitted
studies
(
see
paragraph
4(
d)(
4)
below
for
further
explanation).
In
a
few
cases,
entries
added
to
the
bibliography
late
in
the
review
may
be
preceded
by
a
nine
character
temporary
identifier.
These
entries
are
listed
after
all
MRID
entries.
This
temporary
identifying
number
is
also
to
be
used
whenever
specific
reference
is
needed.

4.
FORM
OF
ENTRY.
In
addition
to
the
Master
Record
Identifier
(
MRID),
each
entry
consists
of
a
citation
containing
standard
elements
followed,
in
the
case
of
material
submitted
to
EPA,
by
a
description
of
the
earliest
known
submission.
Bibliographic
conventions
used
reflect
the
standard
of
the
American
National
Standards
Institute
(
ANSI),
expanded
to
provide
for
certain
special
needs.

a
Author.
Whenever
the
author
could
confidently
be
identified,
the
Agency
has
chosen
to
show
a
personal
author.
When
no
individual
was
identified,
the
Agency
has
shown
an
identifiable
laboratory
or
testing
facility
as
the
author.
When
no
author
or
laboratory
could
be
identified,
the
Agency
has
shown
the
first
submitter
as
the
author.

b.
Document
date.
The
date
of
the
study
is
taken
directly
from
the
document.
When
the
date
is
followed
by
a
question
mark,
115
the
bibliographer
has
deduced
the
date
from
the
evidence
contained
in
the
document.
When
the
date
appears
as
(
19??),
the
Agency
was
unable
to
determine
or
estimate
the
date
of
the
document.

c.
Title.
In
some
cases,
it
has
been
necessary
for
the
Agency
bibliographers
to
create
or
enhance
a
document
title.
Any
such
editorial
insertions
are
contained
between
square
brackets.

d.
Trailing
parentheses.
For
studies
submitted
to
the
Agency
in
the
past,
the
trailing
parentheses
include
(
in
addition
to
any
selfexplanatory
text)
the
following
elements
describing
the
earliest
known
submission:

(
1)
Submission
date.
The
date
of
the
earliest
known
submission
appears
immediately
following
the
word
"
received."

(
2)
Administrative
number.
The
next
element
immediately
following
the
word
"
under"
is
the
registration
number,

experimental
use
permit
number,
petition
number,
or
other
administrative
number
associated
with
the
earliest
known
submission.

(
3)
Submitter.
The
third
element
is
the
submitter.
When
authorship
is
defaulted
to
the
submitter,
this
element
is
omitted.

(
4)
Volume
Identification
(
Accession
Numbers).
The
final
element
in
the
trailing
parentheses
identifies
the
EPA
accession
number
of
the
volume
in
which
the
original
submission
of
the
study
appears.
The
six­
digit
accession
number
follows
the
symbol
"
CDL,"
which
stands
for
"
Company
Data
Library."
This
accession
number
is
in
turn
followed
by
an
alphabetic
suffix
which
shows
the
relative
position
of
the
study
within
the
volume.
116
Product
Chemistry
00067961
Heinrichs,
L.
(
1981)
Complete
Analysis
of
CGA­
64250
Technical
by
Liquid
Chromatography,
Gas
Chromatography,
and
Thin
Layer
Chromatography.
Method
no.
PA­
227R
dated
Jan
20,
1981.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244267­
B)

40583701
Brown,
R.;
Lail,
L.
(
1988)
Product
Chemistry:
CGA­
64250
Technical:
Study
No.
PC­
87­
026.
Unpublished
compilation
prepared
by
Ciba­
Geigy
Corp.
81
p.

40583702
Brown,
R.;
Lail,
L.
(
1988)
Product
Chemistry:
CGA­
64250
Technical:
Study
No.
PC­
87­
026.
Unpublished
compilation
prepared
by
Ciba­
Geigy
Corp.
98
p.

40583703
Brown,
R.;
Lail,
L.
(
1988)
Product
Chemistry:
CGA­
64250
Technical:
Study
No.
PC­
87­
026.
Unpublished
compilation
prepared
by
Ciba­
Geigy
Corp.
81
p.

42030201
Lail,
L.
(
1991)
Product
Chemistry
of
CGA­
64250
Technical:
Lab
Proj­
ect
Number:
PC­
91­
024.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
5
p.

43420701
McCain,
P.
(
1994)
CGA­
64250
Technical:
Supplement
to
Product
Chemistry:
(
Manufacturing
Process).
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
70
p.

43698701
McCain,
P.
(
1994)
CGA­
64250
Technical:
Supplement
to
Product
Chemistry:
Lab
Project
Number:
AG­
87/
22P.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
12
p.

43764401
McCain,
P.
(
1995)
CGA­
64250
Technical:
Product
Chemistry:
Supplement:
Lab
Project
Number:
Z:\
CC­
DOC\
PRODCHEM\
405­
A.
DOC.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
14
p.

43764402
McCain,
P.
(
1995)
CGA­
64250
Technical:
Product
Chemistry:
(
Analysis
and
Certification
of
Product
Ingredients):
Lab
Project
Number:
Z:\
CCDOC
PRODCHEM\
40583702.
DOC:
13­
02­
1995.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
68
p.

Ecological
Effects
00067921
(
00072209,
00244273)
Ballantine,
L.
G.;
Nixon,
W.
B.
(
1980)
Environmental
Safety
of
Technical
CGA­
64250
to
Representative
Wildlife
Species:
Report
No.
ABR­
80049.
Summary
of
studies
244273­
B
through
244273­
I.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
A)

00067922
Thompson,
C.
M.;
Griffen,
J.;
Cranor,
W.
(
1980)
Acute
Toxicity
of
CGA­
64250
to
Bluegill
Sunfish
(
Lepomis
macrochirus):
Static
Acute
Bioassay
Report
#
26037.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Analytical
Bio
Chemistry
Laboratories,
Inc.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
B)

00067923
Thompson,
C.
M.;
Griffen,
J.;
Cranor,
W.
(
1980)
Acute
Toxicity
of
CGA­
64250
to
Rainbow
Trout
(
Salmo
gairdneri):
Static
Acute
Bioassay
Report
#
26038.
117
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Analytical
Bio
Chemistry
Laboratories,
Inc.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
C)

00067925
Forbis,
A.
D.;
Boudreau,
P.;
Cranor,
W.
(
1980)
Acute
Toxicity
of
CGA­
64250
to
Daphnia
magna:
Static
Acute
Bioassay
Report
#
26040.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Analytical
Bio
Chemistry
Laboratories,
Inc.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
E)

00067926
Fink,
R.;
Beavers,
J.
B.;
Joiner,
G.;
et
al.
(
1980)
Final
Report:
Acute
Oral
LD50­­
Mallard
Duck:
Project
No.
108­
194.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Wildlife
International,
Ltd.
and
Washington
College,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
G)

00067927
Fink,
R.;
Beavers,
J.
B.;
Joiner,
G.;
et
al.
(
1980)
Final
Report:
Eight­
day
Dietary
LC50­­
Mallard
Duck:
Project
No.
108­
192.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Wildlife
International,
Ltd.
and
Washington
College,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
I)

00079689
Fink,
R.;
Beavers,
J.
B.;
Joiner,
G.;
et
al.
(
1980)
Final
Report:
Acute
Oral
LD50­­
Bobwhite
Quail:
Project
No.
108­
193.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Wildlife
International,
Ltd.
and
Washington
College,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
F)

00084008
(
00072210)
Reinert,
J.
C.
(
1980)
Estimating
the
Maximum
Concentration
of
Pesticides
in
the
Environment
as
a
Consequence
of
Specific
Events.
(
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Pro­
grams,
Hazard
Evaluation
Div.,
Environmental
Fate
Branch;
unpublished
study;
CDL:
246167­
B)

00132921
Ward,
G.
(
1981)
Acute
Toxicity
of
CGA­
64250
to
Spot
...:
Report
No.
BP­
81­
7­
123R.
Rev.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
C)

00132922
Hitz,
H.;
Kurmann,
F.;
Mendezu,
C.;
et
al.
(
1981)
Report
on
the
Acute
Toxicity
of
CGA
64250
to
Bluegill
...:
Test
No.
81
03
03.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
D)

00132924
Ward,
G.
(
1983)
Acute
Toxicity
of
Tilt
3.6E
to
Spot
...:
Report
No.
BP­
83­
4­
48.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
F)

00132926
Hitz,
H.;
Kurmann,
F.;
Mendezu,
C.;
et
al.
(
1981)
Report
on
the
Test
for
Acute
Toxicity
of
CGA
64
250
to
Rainbow
Trout:
Project
No.
81
03
01.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
H)

00132927
Buchanan,
J.;
Pell,
I.
(
1980)
The
Acute
Toxicity
of
2
Formulations
of
CGA
118
64,250
to
the
Carp
and
the
Rainbow
Trout:
CBG
276/
80961.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Huntingdon
Research
Centre,
Eng.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
I)

00132932
LeBlanc,
G.;
Surprenant,
D.
(
1983)
Acute
Toxicity
of
Tilt
3.6E
to
the
Water
Flea.
Report
#
BW­
83­
2­
1367.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G,
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
N)

00132933
Ward,
G.
(
1983)
Acute
Toxicity
of
Tilt
3.6E
to
Eastern
Oysters
...:
Report
No.
BP­
83­
3­
42.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
O)

00132934
Ward,
G.
(
1983)
Acute
Toxicity
of
Tilt
3.6E
to
Mysid
Shrimp
...:
Report
No.
BP­
83­
4­
50.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
P)

00132937
Hollister,
T.
(
1981)
The
Effect
of
CGA­
64250
to
the
Freshwater
Alga
Selenastrum
capricornutum:
Report
No.
BP­
81­
7­
129­
R.
Rev.
(
Un­
published
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
S)

00132938
Hollister,
T.
(
1981)
The
Effect
of
CGA­
64250
to
the
Freshwater
Diatom
Navicula
seminulum:
Report
No.
BP­
81­
8­
134R.
Rev.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
T)

00132939
Hollister,
T.
(
1981)
The
Effect
of
CGA­
64250
to
the
Marine
Alga
Skeletonema
costatum:
Report
No.
BP­
81­
8­
136­
R.
Rev.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG
&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
U)

00133362
Hollister,
T.
(
1981)
The
Effect
of
CGA­
64250
to
the
Blue­
green
Alga.
Project
No.
R26;
Report
No.
BP­
81­
8­
137­
R.
Rev.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
EG&
G
Bionomics,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072210­
A)

00133366
Ullmann,
L.
(
1978)
Report
on
8­
day­
feeding
Toxicity
in
the
Adult
Japanese
Quail
of
Technical
CGA
64250:
Project
No.
785254.
(
Un­
published
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072210­
I)

00133367
Ullmann,
L.
(
1978)
Report
on
8­
day­
feeding
Toxicity
in
the
3­
day
Old
Peking
Duck
of
Technical
CGA
64250:
Project
#
785255.
(
Un­
published
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
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Geigy
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NC;
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One­
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119
Bobwhite
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108­
202.
Final
rept.
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Tier
2
Vegetative
Vigor
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Phytotoxicity
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Propiconazole:
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418.
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Geigy
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141
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Maggio,
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2
Seedling
Emergence
Nontarget
Phytotoxicity
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Using
Propiconazole:
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Project
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LR90­
420.
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Geigy
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149
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Bathe,
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Acute
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LD50
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Rat
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CGA
64250:
Project
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785244.
(
Unpublished
study
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28,
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100­
618;
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Geigy
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Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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00058596
Bathe,
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Dermal
LD50
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64250:
Project
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785245.
(
Unpublished
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Jan
28,
1981
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100­
618;
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Geigy
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Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244271­
G)

00058597
Sachsse,
K.;
Ullmann,
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1978)
Eye
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in
the
Rabbit
after
Single
Application
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CGA
64250:
Project
No.
785248.
(
Unpublished
study
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Jan
28,
1981
under
100­
618;
prepared
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Ciba­
Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244271­
H)

00058598
Sachsse,
K.;
Ullmann,
L.
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1978)
Skin
Irritation
in
the
Rabbit
after
Single
Application
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Technical
CGA
64250:
Project
No.
785249.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
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Geigy
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Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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244271­
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00058600
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1979)
Report
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Skin
Sensitizing
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Contact
Allergenic)
Effect
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Guinea
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Technical
CGA
64250:
Project
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785250.
(
Unpublished
study
received
Jan
28,
1981
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100­
618;
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Geigy
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Switzerland,
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by
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Geigy
Corp.,
Greensboro,
N.
C.;
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244271­
K)

00058602
Hool,
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1979)
Dominant
Lethal
Study:
CGA
64
250:
Mouse:
No.
of
Experiment:
790034.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Ciba­
Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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244271­
M)

00058603
Hool,
G.;
Langauer,
M.
(
1979)
Nucleus
Anomaly
Test
in
Somatic
Interphase
Nuclei:
CGA
64
250:
Chinese
Hamster:
No.
of
Experiment:
79­
0805.
120
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Ciba­
Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244271­
N)

00058606
Sachsse,
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Suter,
P.;
Luetkemeier,
H.;
et
al.
(
1979)
CGA
64'
250
Techn.
Three
Months
Toxicity
Study
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Project
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Final
rept.
(
Unpublished
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28,
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100­
618;
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Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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Q)

00058607
Sachsse,
K.;
Bathe,
R.;
Luetkemeier,
H.;
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1979)
CGA
64'
250
3­
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Toxicity
Study
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Dogs.
Final
rept.
(
Unpublished
study
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28,
1981
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100­
618;
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Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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244271­
R)

00074506
Muecke,
W.
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1979)
Characterization
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Urinary
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Faecal
Metabolites
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Rats
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Oral
Application
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CGA
64
250:
Project
Report
35/
79.
(
Unpublished
study
received
Jun
8,
1981
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100­
EX­
69;
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Geigy
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Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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070164­
L)

00074507
Mucke,
W.
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1981)
The
Major
Metabolic
Pathways
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CGA
64
250
in
the
Rat:
Project
Report
9/
81.
(
Unpublished
study
received
Jun
8,
1981
under
100­
EX­
69;
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Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
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070164­
M)

00116591
Larson,
E.;
Matthews,
R.;
Naismith,
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1982)
21
Day
Dermal
Toxicity
Study
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Rabbits:
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CGA­
64250
Technical):
PH
430­
CG­
001­
82.
Rev.
(
Unpublished
study
received
Oct
4,
1982
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100­
641;
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Pharmakon
Research
International,
Inc.,
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by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
248442­
E)

00129570
Hunter,
B.;
Scholey,
D.;
Haywood,
R.;
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1982)
CGA
64
250:
Long­
term
Feeding
Study
in
Mice:
CBG/
196/
81827.
Final
rept.
(
Unpublished
study
received
Jul
21,
1983
under
100­
641;
prepared
by
Huntingdon
Research
Centre,
Eng.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
250784­
A;
250785;
250786)

00129918
Hunter,
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Slater,
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Heywood,
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1982)
CGA
64
250:
Potential
Tumorigenic
and
Toxic
Effects
in
Prolonged
Dietary
Administration
to
Rats:
CBG
193/
8284
(
Test
No.
789023).
Final
rept.
(
Unpublished
study
received
Jul
21,
1983
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100­
641;
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by
Huntingdon
Research
Centre,
Eng.,
submitted
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Ciba­
Geigy
Corp.,
Greensboro,
NC;
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250787­
A;
250788;
250789;
250790)

00133343
Arni,
P.
(
1982)
Saccharomyces
cerevisiae
D7/
Mammalian­
microsome
Mutagenicity
Test
in
vitro
with
CGA
64
250
(
Test
for
Mutagenic
Properties
in
Yeast
Cells):
Experiment
No.
811558.
(
Unpublished
study
received
Dec
12,
1983
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100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072206­
C)

00133347
Puri,
E.
(
1982)
Autoradiographic
DNA
Repair
Test
on
Human
Fibro­
blasts:
CGA
121
64
250
(
in
vitro
Test
for
DNA­
damaging
Properties):
Experiment
No.
811655.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072206­
G)

00133348
Puri,
E.
(
1982)
Autoradiographic
DNA
Repair
Test
on
Rat
Hepatocytes:
CGA
64
250
(
in
vitro
Test
for
DNA­
damaging
Properties):
Experiment
No.
811514.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072206­
H)

00133349
Strasser,
F.
(
1982)
BALB/
3T3
Cell
Transformation
Assay:
CGA
64
250
(
in
vitro
Test
for
Transformation­
inducing
Properties
in
Mammalian
Fibroblasts):
Experiment
No.
790806.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL
072206­
J)

00151514
Borders,
C.;
Salamon,
C.
(
1985)
Two­
Generation
Reproduction
Study
in
Albino
Rats
with
CGA­
64250
Technical:
Toxigenics
Study
450­
1202.
Unpublished
study
prepared
by
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Inc.
1886
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00151515
Johnson,
W.;
Thompson,
S.
(
1985)
One­
year
Subchronic
Oral
Toxicity
Study
in
Beagle
Dogs
with
CGA­
64250
Technical:
(
Final
Report):
FDRL
Study
No.
7737.
Unpublished
study
prepared
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570
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The
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[
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Carbon
14]­
phenyl­
CGA
64
250
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Mice
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Unlabelled
CGA
64
250:
Project
Report
6/
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Unpublished
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Geigy
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52
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Giknis,
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CGA­
Technical:
Teratology
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Segment
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Study
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Project
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86004.
Unpublished
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performed
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Ciba­
Geigy
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425
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40425004
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Cresswell,
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carbon­
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520
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Hartmann,
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64250
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Acute
Aerosol
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Study
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Subchronic
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64250
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F­
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Geigy
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302
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Potrepka,
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13­
Week
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64250
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Male
Mice:
Lab
Project
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F­
00107.
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study
prepared
122
by
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Geigy
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226
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64250
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Geigy
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Dermal
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?
carbon
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Propiconazole:
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ABR­
86053:
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64250
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MRID
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42050502):
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64250
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28,
1981
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100­
618;
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Geigy,
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Switzerland,
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Ciba­
Geigy
Corp.,
Greensboro,
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C.;
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1980)
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28,
1981
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100­
618;
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Univ.
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Entomology,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244269­
M)

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Keller,
A.
(
1980)
Degradation
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CGA
64
250
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Project
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80.
(
Unpublished
study
received
Jul
21,
1983
under
100­
641;
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by
Ciba­
Geigy,
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
250783­
D)

00129914
Keller,
A.
(
1982)
Degradation
of
Carbon
14­
dioxolane­
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14­
phenylring
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CGA
64
250
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TILT)
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Project
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08/
82.
(
Unpublished
study
received
Jul
21,
1983
under
100­
641;
prepared
by
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Geigy,
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
250783­
F)

00133375
Keller,
A.
(
1982)
Degradation
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CGA
64250
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Aerobic
Soil:
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the
Major,
Polar
Soil
Metabolite:
Project
Report
45/
82.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switzerland,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
123
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W.;
Bruns,
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1982)
Isolation
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Identification
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Photolysis
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CGA­
64250:
Project
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1127.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
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Rhoads
Scientific
Co.,
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by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
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072220­
C)

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Ciba­
Geigy
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(
1985)
[
Field
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1170
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Honeycutt,
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Field
Dissipation
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CGA­
64250
(
Tilt):
Report
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EIR­
85028:
Field
Test
No.
5­
FR­
4­
84.
Unpublished
study
prepared
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Geigy
Corp.
446
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41727001
Saxena,
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The
Adsorption
and
Desorption
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Carbon
14
labeled
Propiconazole
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Representative
Agricultural
Soils:
Lab
Project
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HLA
6117­
140.
Unpublished
study
prepared
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73
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Das,
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Photodegradation
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Phenyl(
U)­
Carbon14
Propiconazole
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Aqueous
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Buffered
at
Ph
7
Under
Artificial
Sun­
light:
Lab
Project
Number:
90070:
85­
90.
Unpublished
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Spare,
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Soil
Photolysis
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Lab
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113­
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85
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Das,
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(
1992)
Metabolism
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U)­
carbon
14
Propiconazole
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Aerobic
Aquatic
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Lab
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90071:
86­
90.
Unpublished
study
prepared
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Innovative
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122
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Das,
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1992)
Metabolism
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Phenyl
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U)­
carbon
14|
Propiconazole
Under
Anaerobic
Aquatic
Soil
Conditions:
Lab
Project
Number:
90072:
87­
90.
Unpublished
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prepared
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Innovative
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164
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1998)
Aged
Leaching
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carbon­
14)
Propiconazole
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Four
Soil
Types:
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ORETF
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40180702
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Determination
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517.
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4
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40692201
Cheung,
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Propiconazole­­
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Geigy
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128
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40692203
Perez,
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Determination
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dichlorobenzoic
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31
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Perez,
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454
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dichlorobenzoic
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Unpublished
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11
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Nixon,
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Validation
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448
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454
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64250
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2,4­
dichlorobenzoic
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14
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Geigy
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70
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Geigy
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30
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40890701
Cheung,
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Propiconazole­­
Grasses
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83
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Propiconazole­­
Wild
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99
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Propiconazole­
Stoned
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Propiconazole
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Double­
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behind
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Unpublished
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Geigy
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127
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celery
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88057,
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Lab
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1990)
Propiconazole:
Determination
of
Extract
Storage
Stability
for
Total
Propiconazole
Residues
in
Weathered
Crops:
Lab
Project
I.
D.:
ABR­
90017.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.,
Agricultural
Div.
56
p.

41823301
Doweyko,
A.
(
1990)
Metabolism
of
Phenyl
carbon
14
Propiconazole
in
Goats:
Lab
Project
Number:
F­
00052.
Unpublished
study
pre­
pared
by
Ciba­
Geigy
Corp.
66
p.

41823302
Doweyko,
A.
(
1990)
Metabolism
of
Phenyl
carbon
14|
Propiconazole
in
Chickens:
Lab
Project
Number:
F­
00051.
Unpublished
study
pre­
pared
by
Ciba­
Geigy
Corp.
71
p.

41823304
Yokley,
R.
(
1990)
Validation
of
Analytical
Method
AG­
517
for
the
Determination
of
Total
Residues
of
Propiconazole
in
Goat
Tissues,
Milk,
and
Blood
and
Poultry
Tissues:
Lab
Project
Number:
abr­
90067.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
54
p.

41823305
Beidler,
W.
(
1991)
Propiconazole:
Magnitude
of
Residues
of
Propiconazole
in
Grasses
Grown
for
Seed
Following
Application
of
Tilt
3.6E:
Lab
Project
Number:
ANR­
90101.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
155
p.

42061301
Biehn,
W.
(
1991)
Propiconazole­­
Magnitude
of
Residue
on
Mint:
Lab
Project
Number:
IR­
4
PR
4127.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
101
p.

42182901
Cheung,
M.
(
1991)
Propiconazole
Residues
in
Oat
Forage,
Straw,
Grain
and
Oat
Grain
Processed
Fractions
Resulting
from
Application
of
Tilt:
Residue
Summary
129
with
Amendment
1:
Lab
Project
Number:
ABR­
89102.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
214
p.

42511401
Smith,
J.
(
1991)
Propiconazole:
Response
to
EPA
Review
of
Propiconazole
(
TILT
3.6E)
on
Wild
Rice
Including
Results
of
Additional
Field
Trials:
Lab
Project
Number:
ABR­
90091.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
74
p.

42564004
Cheung,
M.
(
1992)
Responses
to
EPA
Review
of
Residue
Data
for
Propiconazole
on
Corn:
Lab
Project
Number:
ABR­
92064.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
91
p.

42564005
Manuli,
P.
(
1992)
Magnitude
of
Residues
of
Propiconazole
in
Field
Corn
Forage
and
Grain
and
Processed
Fractions
following
Application
of
Tilt
3.6E
Formulation
to
Field
Corn:
Lab
Project
Number:
ABR­
92047.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
161
p.

42564006
Doweyko,
A.
(
1992)
F­
00052:
Metabolism
of
Phenyl­
carbon
14
Propiconazole
in
Goats:
Addendum
1
to
Final
Report.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
9
p.

42605801
Cheung,
M.
(
1992)
Propiconazole:
Responses
to
EPA
Review
of
Residue
Data
for
Propiconazole
on
Peanuts
Reported
in
ABR­
88068
MRID
Number
40692201:
Lab
Project
Number:
ABR­
92066.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
26
p.

42634101
Smith,
J.
(
1992)
Magnitude
of
Residues
of
Propiconazole
in
or
on
Grasses
Grown
for
Seed
following
Application
of
Tilt
3.6E:
Lab
Project
Number:
ABR­
92070.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
165
p.

42634102
Wurz,
R.
(
1993)
Propiconazole:
Magnitude
of
the
Residue
in
or
on
Grass
Seed
Screening
Pellets
Obtained
from
Market
Basket
Samplings:
Lab
Project
Number:
ABR­
92071.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
83
p.

42915601
Watson,
G.
(
1993)
Letter
sent
to
C.
Lewis
dated
September
3,
1993
concerning
a
report
of
Propiconazole
residues
above
current
tolerance
in
rice
commodities.
Prepared
by
Ciba­
Geigy
Corp.
10
p.

42983001
Doweyko,
A.
(
1990)
Metabolism
of
(
Phenyl­(
carbon
14))
­
Propiconazole
in
Chickens:
Addendum
I:
Lab
Project
Number:
F­
00051.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
11
p.

43314201
Wurz,
R.
(
1994)
Stability
of
Total
Residues
of
Propiconazole
in
Weathered
Grass
Straw,
Forage
and
Seed
Samples
under
Freezer
Storage
Conditions:
Lab
Project
Number:
ABR/
94008.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.,
Biochemistry
Dept.
62
p.

43314202
Beidler,
W.
(
1994)
Response
to
EPA
Review
of
Petition
for
Tolerances
of
Propiconazole
in
Oat
Grain
and
Straw:
Lab
Project
Number:
ABR/
93068.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
Biochemistry
Dept.
11
p.
130
43424601
Thompson,
D.
(
1994)
Propiconazole:
Magnitude
of
Residue
on
Mint­­
Amendment:
Lab
Project
Numbers:
A4127:
4127:
A4127.93­
CIR01.
Unpublished
study
prepared
by
EPL
Bioanalytical
Services,
Inc.;
and
Ciba
Plant
Protection.
402
p.

43434201
Biehn,
W.
(
1994)
Propiconazole:
Magnitude
of
Residue
on
Mushroom:
Lab
Project
Number:
5056:
207S01:
5056.92­
PA05.
Unpublished
study
prepared
by
EPL
Bio­
Analytical
Services,
Inc.;
and
Lehigh
Agricultural
&
Biological
Services,
Inc.
291
p.

43655609
Selman,
F.
(
1995)
Propiconazole­­
Magnitude
of
the
Residues
in
or
on
Cherries
Following
Post
Foliar
Applications
of
Orbit:
Lab
Project
Number:
ABR/
95004.
Unpublished
study
prepared
by
Ciba
Plant
Protection.
225
p.

43825401
Lin,
K.
(
1995)
Propiconazole:
Investigations
into
the
Methylation
of
2,4­
Dichlorobenzoic
Acid
as
a
Part
of
Analytical
Methods
AG­
517
and
AG­
454B:
Lab
Project
Number:
ABR­
94065:
411925:
280­
94.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
141
p.

43825402
Eudy,
L.
(
1995)
Propiconazole:
Stability
of
Propiconazole
Fortified
into
Crops
and
Processed
Fractions
Under
Freezer
Storage
Conditions:
Interim
Report:
Lab
Project
Number:
ABR­
95092:
411925:
207­
94.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
113
p.

44049601
Simoneaux,
B.
(
1996)
Uptake
and
Metabolism
of
CGA­
64250
in
Greenhouse
Grown
Celery
after
Spray
Treatment
with
Phenyl­(
carbon
14)­
CGA­
64250:
Lab
Project
Number:
ABR­
95100:
271­
94:
BIOL­
94015.
Unpublished
study
prepared
by
Ciba
Crop
Protection.
144
p.

44142401
Close,
C.
(
1996)
(
Carbon
14)­
Propiconazole:
Uptake
and
Metabolism
in
Seed
Piece
Dipped
Sugarcane:
(
Final
Report):
Lab
Project
Number:
ABR­
96097:
73­
95:
ANPHI­
96005.
Unpublished
study
prepared
by
Ciba­
Geigy
Corp.
56
p.

44381402
Swain,
W.
(
1997)
Uptake
and
Metabolism
of
CGA­
64250
in
Greenhouse
Grown
Spring
Wheat
after
Spray
Treatment
with
Phenyl­­(
carbon
14)­
CGA­­
64250:
Lab
Project
Number:
ABR­
97039:
502­
95:
BIOL­
95018.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
170
p.

44411201
Lin,
K.
(
1997)
Determination
of
Total
Residues
of
Propiconazole
in
Crops
as
2,4­
Dichlorobenzoic
Acid
Methyl
Ester
by
Capillary
Gas
Chromatography:
Lab
Project
Number:
AG­
626:
571­
97:
411925.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
45
p.
{
OPPTS
860.1340}

44411204
Lin,
K.
(
1997)
Determination
of
Total
Residues
of
Propiconazole
in
Meat,
Milk
and
Eggs
as
2,4­
Dichlorobenzoic
Acid
Methyl
Ester
by
Capillary
Gas
Chromatography:
Lab
Project
Number:
AG­
629:
572­
97:
411925.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
44
p.
{
OPPTS
860.1340}

44411205
Eudy,
L.
(
1997)
Stability
of
Propiconazole
Fortified
into
Crops
and
processed
Fractions
Under
Freezer
Storage
Conditions:
Lab
Project
Number:
ABR­
97085:
131
207­
94:
477925.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
84
p.
{
OPPTS
860.1380}

44411206
Vincent,
T.
(
1997)
Propiconazole­­
Magnitude
of
the
Residues
in
or
on
Wheat,
Including
Processed
Fractions
and
Rotational
Lentils
and
Peas,
Following
Post
Foliar
Applications
of
Tilt:
Lab
Project
Number:
ABR­
95062:
29­
92:
411124.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
506
p.

44411207
Vincent,
T.
(
1997)
Propiconazole­­
Magnitude
of
the
Residues
in
or
on
Wheat,
Including
Processed
Fractions,
Following
an
Application
of
Tilt:
Lab
Project
Number:
ABR­
97101:
94­
95:
411926.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
314
p.
Relates
to
L0000296.

44411208
Vincent,
T.
(
1997)
Propiconazole­­
Magnitude
of
the
Residues
in
or
on
Rice
Following
Application
of
Tilt:
Lab
Project
Number:
ABR­
97110:
49­
96:
411927.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
120
p.

44757208
Vincent,
T.;
Ediger,
K.
(
1999)
Propiconazole
and
CGA­
279202­­
Magnitude
of
the
Residues
in
or
on
Wheat:
Final
Report:
Lab
Project
Number:
43­
97:
0S­
FR­
103­
97:
02­
FR­
002­
97.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
1304
p.
{
OPPTS
860.1000,
860.1500,
860.1520}

93194062
Swidersky,
P.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00155644
and
Related
MRIDs
00074496,
00074499,
00074497,
00155646.
Metabolism
Data
and
Correlation
of
Metabolites
in
Target
and
Rotation
Crop
of
Propiconazole:
Report
No.
ABR­
85056.
Prepared
by
CIBA­
GEIGY
CORP.
17
p.

93194064
Wurz,
R.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
40180701
and
Related
MRIDs
40022401,
40154501,
40692204.
Analytical
Method
for
the
Determination
of
Total
Residues
of
Propiconazole
in
Crops
as
2,4­
Dichlorobenzoic
Acid:
AG­
454A.
Prepared
by
CIBA­
GEIGY
CORP.
14
p.

93194067
Wurz,
R.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
40180702
and
Related
MRIDs
40145401.
Analytical
Method
for
the
Determination
of
Total
Residues
of
Propiconazole
in
Meat,
Milk,
and
Eggs
as
2,4­
Dichlorobenzoic
Acid:
AG­
517.
Prepared
by
CIBA­
GEIGY
CORP.
13
p.

93194068
Beidler,
W.;
Senzel,
A.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00133385
and
Related
MRIDs
00074510,
00074511.
Stability
of
Propiconazole
Residues
in
Crops
Under
Freezer
Storage
Conditions:
Projects
ABR­
83086
and
ABR­
81018.
Prepared
by
CIBA­
GEIGY
CORP.
11
p.

93194070
Senzel,
A.;
Ross,
J.;
Clear,
C.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00137861.
Cow
Meat
and
Milk­­
Feeding:
Propiconazole
Residues:
Projects
ABR­
84022
and
83091;
and
Poultry
Meat
and
Eggs:
Feeding:
Propiconazole
Residues:
Projects
ABR­
84022
and
83092.
Prepared
by
Ciba­
Geigy
Corporation.
36
p.

93194071
Senzel,
A.;
Ross,
J.;
Clear,
C.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00137150.
Magnitude
of
the
Residues
of
Propiconazole
in
Bananas:
ABR
132
83100.
Prepared
by
CIBA­
GEIGY
CORP.
19
p.

93194072
Senzel,
A.;
Ross,
J.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00163643.
Magnitude
of
the
Residues
of
Propiconazole
in
Wheat,
Barley,
and
Rye:
Project
ABR­
84018.
Prepared
by
CIBA­
GEIGY
CORP.
16
p.

93194073
Senzel,
A.;
Ross,
J.;
Clear,
C.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
40890701.
Magnitude
of
the
Residues
of
Propiconazole
in
Grasses
for
Seed:
Project
ABR­
83100.
Prepared
by
CIBA­
GEIGY
CORP.
17
p.

93194075
Senzel,
A.;
Ross,
J.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00163687
and
Related
MRIDs
00074508,
00074509,
00074495,
00137861,
00163643,
41063801.
Magnitude
of
the
Residues
of
Propiconazole
in
Rice:
Project
ABR­
84022.
Prepared
by
CIBA­
GEIGY
CORP.
15
p.

93194077
Senzel,
A.;
Ross,
J.;
Clear,
C.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00131090.
Magnitude
of
the
Residues
of
Propiconazole
in
Sugarcane:
Project
ABR­
83065.
Prepared
by
CIBA­
GEIGY
CORP.
28
p.

93194079
Senzel,
A.;
Ross,
J.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00163687
and
Related
MRIDs
00074495,
00074508.
Magnitude
of
the
Residues
of
Propiconazole
in
Processed
Food/
Feed
from
Rice:
Project
ABR­
84022.
Prepared
by
CIBA­
GEIGY
CORP.
20
p.

93194080
Senzel,
A.;
Ross,
J.;
Clear,
C.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Summary
of
MRID
00163643.
Magnitude
of
the
Residues
of
Propiconazole
in
Processed
Food/
Feed
from
Wheat:
Project
ABR­
84018.
Prepared
by
CIBA­
GEIGY
CORP.
18
p.

93194085
Madrid,
V.;
Cassidy,
J.
(
1990)
Ciba­
Geigy
Corp.
Phase
3
Reformat
of
MRID
00074503
and
Related
MRIDs
00067905,
00074504.
Characterization
of
Metabolites
in
Urine,
Milk
and
Liver
of
a
Goat
Treated
with
Triazole­(
Carbon
14)­
CGA­
64250:
Propiconazole.
Prepared
by
CIBA­
GEIGY
CORP.
54
p.

Other
Studies
00067924
Thompson,
C.
M.;
Griffen,
J.;
Cranor,
W.
(
1980)
Acute
Toxicity
of
CGA­
64250
to
Channel
Catfish
(
Ictalurus
punctatus):
Static
Acute
Bioassay
Report
#
26039.
(
Unpublished
study
received
Jan
28,
1981
under
100­
618;
prepared
by
Analytical
Bio
Chemistry
Laboratories,
Inc.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
N.
C.;
CDL:
244273­
D)

00132930
De
Morsier,
A.;
Kurmann,
F.;
Mendezu,
C.;
et
al.
(
1982).
Report
on
the
Test
for
Acute
Toxicity
of
CGA
64
250
to
Cat
Fish:
Project
No.
81
03
04.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
prepared
by
Ciba­
Geigy
Ltd.,
Switz.,
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
072209­
L)

00151517
Froehlich,
E.;
Bentley,
P.;
Staeubli,
W.;
et
al.
(
1984)
Promotion
Study
with
CGA
64250:
[
Study
on
the
Influence
of
CGA
64250
in
the
Formation
of
Focal
Proliferative
Changes
in
the
Rat
Liver]:
GU
Exploratory
Research
Project
No.
133
834015.
Unpublished
study
prepared
by
Ciba­
Geigy
Ltd.
553
p.

40425002
Mallows,
S.;
Levy,
E.;
Goknis,
M.;
et
al.
(
1987)
CGA­
64250:
A
Modified
Teratology
(
Segment
II)
Study
in
Albino
Rats
...:
Laboratory
Project
ID
86189.
Unpublished
study
prepared
by
Ciba­
Geigy
Corporation.
408
p.

45215802
Weber,
E.
(
1999)
Assessment
of
Hepatic
Cell
Proliferation
in
Male
Mice
(
Propiconazole):
Final
Report:
Lab
Project
Number:
CB
97/
23:
539­
98.
Unpublished
study
prepared
by
Novartis
Crop
Protection
AG.
59
p.

45215803
Beilstein,
P.
(
1998)
Effects
on
Biochemical
Parameters
in
the
Liver
Following
Administration
to
Male
Mice:
Final
Report
(
Propiconazole):
Lab
Project
Number:
CB
97/
22:
798­
97.
Unpublished
study
prepared
by
Novartis
Crop
Protection
AG.
68
p.
134
APPENDIX
D:
Technical
Support
Documents
for
Propiconazole
Additional
documentation
in
support
of
this
RED
is
maintained
in
EPA's
Pesticide
Docket
under
docket
number
EPA­
HQ­
OPP­
2005­
0497.
This
docket
may
be
viewed,
in
paper
form,
in
the
OPP
docket
room
located
at
Room
S­
4900,
One
Potomac
Yard,
2777
South
Crystal
Drive,
Arlington,
VA.
The
docket
is
open
Monday
through
Friday,
excluding
Federal
holidays,
from
8:
30
a.
m.
to
4:
00
p.
m.
All
documents
in
this
docket
may
also
be
viewed
or
downloaded
via
the
Internet
at
http://
www.
regulations.
gov,
under
the
docket
number
listed
above.

The
Preliminary
Risk
Assessments
for
Propiconazole,
which
were
made
publicly
available
on
February
15,
2006,
and
public
comments
on
these
risk
assessments,
are
also
available
under
docket
number
EPA­
HQ­
OPP­
2005­
0497.
Registrant
requests
to
amend
their
propiconazole
registrations
to
delete
certain
uses,
and
the
March
8,
2006
Federal
Register
Notice
announcing
receipt
of
this
are
also
available
under
this
docket
number.

Final
revised
risk
assessment
documents
supporting
the
reregistration
eligibility
decision
for
propiconazole
are
listed
below.
These
documents
may
also
be
viewed
in
the
Pesticide
docket,
or
viewed
or
downloaded
from
the
Internet
as
described
above.

Human
Health
Risk
Assessment
Documents
1.
Propiconazole:
Phase4,
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED).
June
28,
2006.
2.
Propiconazole:
Phase
IV,
revised
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document
(
RED).
June
15,
2006.
3.
Propiconazole:
Amendment
to
the
Propiconazole
Reregistration
Eligibility
Decision
(
RED)
Document
for
Children's
Postapplication
Exposure
Treated
Structures.
June
20,
2006.
4.
Propiconazole
Revised
Acute
and
Chronic
Dietary
Exposure
Assessments
for
Reregistration
Evaluation
[
sic]
Decision
(
RED)
 
Phase
4.
June
7,
2006.
5.
Propiconazole
(
122101):
Reregistration
Eligibility
Decision
(
RED)
Document;
Revised
Residue
Chemistry
Considerations.
June
15,
2006.

Environmental
Fate
and
Ecological
Effects
Documents
6.
Environmental
Fate
and
Effects
Division
Revised
RED
for
the
Reregistration
of
Propicnazole.
June
29,
2006.
7.
Terrestrial
Plant
Runoff
Risk
Assessment
for
Propiconazole
on
Turf
Using
PRZM.
July
14,
2006.
8.
Revised
Drinking
Water
Assessment
of
Propiconazole.
June
7,
2006.

Risk
Assessments
and
Related
Documents
for
the
Free
Triazoles
9.
Meeting
Summary:
EPA/
FDA
Joint
Teleconference
on
July
11,
2006
to
Discuss
1,2,4­
Triazole
(
Free
TRiazole)
as
a
Common
Metabolite
of
Triazole
Derivative
Fungicides
and
Anastrozole,
a
Drug.
July
18,
2006.
10.
EPA
1,2,4­
Triazole
Consult
Response.
Memo
from
John
Lazor,
Director,
FDA
Division
of
Clinical
Pharmacology
4,
to
Debra
Edwards,
Director,
Special
Review
and
Reregistration
Division.
May
19,
2006.
135
11.
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.
Michael
Doherty
et
al.
February
7,
2006.
12.
Response
to
Triazole
Task
Force
Comments
on
the
FQPA
Drinking
Water
Assessment
for
1,2,4­
Triazole
(!,
2,4­
T),
Triazole
alanine
(
TA),
and
Triazole
Acetic
Acid
(
TAA).
June
15,
2006.

Documents
on
Propiconazole
Use
and
Usage
13.
Usage
Report
Package
in
Support
of
Reregistration
for
the
Fungicide
Propiconazole
(
122101).
April
26,
2006.
136
APPENDIX
E:
Generic
Data
Call­
In
(
DCI)
for
Propiconazole
This
is
a
placeholder
for
the
Generic
DCI
for
the
pesticide
active
ingredient
propiconazole.
The
Generic
DCI
has
not
yet
been
issued
and
will
be
issued
at
a
future
date.
Generic
data
requirements
for
propiconazole
are
listed
in
the
RED
document.
137
APPENDIX
F:
Product­
specific
Data
Call­
In
(
DCI)
for
Propiconazole
This
is
a
placeholder
for
the
Product
DCI
for
all
pesticide
products
containing
the
pesticide
active
ingredient
propiconazole.
The
Product
DCI
has
not
yet
been
issued
and
will
be
issued
at
a
future
date.
138
APPENDIX
G:
Batching
of
Propiconazole
Products
for
Meeting
Acute
Toxicity
Testing
Data
Requirements
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
PROPICONAZOLE
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.
Notwith­
standing
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
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.
139
Seventy
nine
products
were
found
which
contain
Propiconazole
as
the
active
ingredient.
These
products
have
been
placed
in
fourteen
batches
and
a
no
batch
group
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.

Batching
Instructions:

Batch
13:
Studies
should
be
conducted
on
EPA
Reg.
No.
60061­
119
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
100­
618
95.0
43813­
13
95.0
62719­
347
93.8
66222­
59
93.0
74054­
2
93.0
74054­
3
93.0
Batch
2
EPA
Reg.
No.
Percent
Active
Ingredient
43813­
21
50.0
43813­
37
50.0
Batch
3
EPA
Reg.
No.
Percent
Active
Ingredient
100­
780
45.0
100­
781
45.0
100­
1153
45.0
Batch
4
EPA
Reg.
No.
Percent
Active
Ingredient
100­
736
41.8
100­
737
41.8
Batch
5
EPA
Reg.
No.
Percent
Active
Ingredient
100­
617
41.8
100­
702
41.8
100­
1233
41.8
62719­
346
41.8
66222­
42
41.8
66222­
118
41.8
Batch
6
EPA
Reg.
No.
Percent
Active
Ingredient
43813­
15
23.6
43813­
16
23.6
140
Batch
7
EPA
Reg.
No.
Percent
Active
Ingredient
43813­
41
15.0
43813­
42
15.0
Batch
7
EPA
Reg.
No.
Percent
Active
Ingredient
53883­
174
14.3
66222­
41
14.3
Batch
8
EPA
Reg.
No.
Percent
Active
Ingredient
100­
741
14.3
100­
772
14.3
228­
396
14.3
34704­
879
14.3
53883­
129
14.3
60063­
27
14.3
66330­
325
14.3
69117­
3
14.3
72112­
3
14.3
79676­
8
14.3
Batch
9
EPA
Reg.
No.
Percent
Active
Ingredient
43813­
19
9.7
75506­
3
9.7
Batch
10
EPA
Reg.
No.
Percent
Active
Ingredient
70227­
6
4.5
71406­
1
4.5
Batch
11
EPA
Reg.
No.
Percent
Active
Ingredient
100­
773
1.55
100­
952
1.55
53883­
128
1.55
53883­
184
1.55
Batch
12
EPA
Reg.
No.
Percent
Active
Ingredient
43813­
43
Propiconazole:
34.0
IPBC:
16.0
43813­
44
Propiconazole:
34.0
IPBC:
16.0
141
Batch
13
EPA
Reg.
No.
Percent
Active
Ingredient
60061­
103
Propiconazole:
0.21
IPBC:
0.21
Tebuconazole:
0.21
60061­
109
Propiconazole:
0.10
IPBC:
0.10
Tebuconazole:
0.10
60061­
119
Propiconazole:
0.98
IPBC:
0.98;
Tebuconazole:
0.98
Batch
14
EPA
Reg.
No.
Percent
Active
Ingredient
74405­
1
Propiconazole:
0.70
Permethrin:
0.35
Tebuconazole:
0.70
75101­
1
Propiconazole:
0.50
Permethrin:
0.43
Tebuconazole:
0.51
No
Batch
EPA
Reg.
No.
Percent
Active
Ingredient
100­
641
14.30
100­
1178
Propiconazole:
11.70
Azoxystrobin:
7.00
100­
1192
Propiconazole:
2.90
Chlorothalonil:
38.50
100­
1216
Propiconazole:
9.54
Azoxystrobin:
5.73
100­
1231
Propiconazole:
4.70
Chlorothalonil:
29.90
Fludioxonil:
1.20
100­
1244
32.40
264­
778
Propiconazole:
20.90
Trifloxystrobin:
25.00
264­
779
Propiconazole:
11.40
Trifloxystrobin:
11.40
352­
699
Propiconazole:
45.00
Fentin
Hydroxide:
40.00
1022­
585
Propiconazole:
3.00
IPBC:
6.00
1448­
394
8.00
1448­
414
Propiconazole:
5.00
Bardac
2280:
25.00
5383­
114
Propiconazole:
7.00
IPBC:
21.60
5383­
120
Propiconazole:
6.00
IPBC:
17.40
142
No
Batch
EPA
Reg.
No.
Percent
Active
Ingredient
9198­
227
Propiconazole:
0.62
Chlorothalonil:
3.90
PCNB:
7.50
57227­
3
Propiconazole:
4.94
Bardac
2280:
46.25
57227­
6
40.00
60061­
102
10.00
60061­
107
Propiconazole:
5.00
Bardac
2280:
46.25
60061­
112
Propiconazole:
3.50
Diiodomethyl­
p­
tolyl
sulfone:
0.95
IPBC:
3.50
60061­
114
4.50
60061­
115
Propiconazole:
0.977
IPBC:
0.979
Tebuconazole:
0.979
60061­
121
Propiconazole:
5.00
IPBC:
5.00
70227­
4
20.00
71711­
17
Propiconazole:
6.00
Flutolanil:
32.00
71711­
24
Propiconazole:
1.80
Chlorothalonil:
21.65
Flutolanil:
17.20
72616­
1
Propiconazole:
5.00
IPBC:
5.00
Maquat:
50.00
75506­
1
Propiconazole:
0.40
Boric
Acid:
9.74
Copper
Carbonate:
18.18
75506­
7
Propiconazole:
5.00
Imidacloprid:
0.50
Tebuconazole:
5.00
143
APPENDIX
H:
List
of
Registrants
Sent
the
Generic
and
Product­
Specific
DCIs
for
Propiconazole
This
is
a
placeholder
for
the
list
of
registrants
sent
the
generic
and
product
DCIs
for
propiconazole.
The
final
list
of
registrants
will
be
compiled
when
the
DCIs
are
issued
(
at
a
future
date).
144
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
following
address
for
the
Document
Processing
Desk.:

Document
Processing
Desk
(
distribution
code)*
Office
of
Pesticide
Programs
(
7504P)
Environmental
Protection
Agency
1200
Pennsylvania
Ave,
NW
Washington,
DC
20460­
0001
*
Distribution
Codes
are
as
follows:
(
APPL)
Application
for
product
registration
(
AMEND)
Amendment
to
existing
registration
(
CAN)
Voluntary
Cancellation
(
EUP)
Experimental
Use
Permit
(
DIST)
Supplemental
Distributor
Registration
(
SLN)
Special
Local
Need
(
NEWCO)
Request
for
new
company
number
(
NOTIF)
Notification
(
PETN)
Petition
for
Tolerance
(
XFER)
Product
Transfer
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.
If
you
want
these
forms
mailed
or
faxed
to
you,
please
contact
Lois
White,
white.
lois@
epa.
gov
or
Floyd
Gayles,
gayles.
floyd@
epa.
gov.

If
you
have
any
questions
concerning
how
to
complete
these
forms,
please
contact
OPP's
ombudsperson
for
conventional
pesticide
products:
Linda
Arrington,
(
703)
305­
5446
The
following
Agency
Pesticide
Registration
Forms
are
currently
available
via
the
Internet
at
the
following
locations:
145
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
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
http://
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.
146
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
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
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.
147
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
website.

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
website:
http://
npic.
orst.
edu
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,
self­
addressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

 
Date
of
receipt
 
EPA
identifying
number
 
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
CAS
number
if
one
has
been
assigned.