Document ID: EPA-HQ-OPP-2005-0497-0035
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-23T04:00Z

RED
FACTS;
Propiconazole
EPA
738R­
06­
027
Pesticide
Reregistration
July
18,
2006
The
Environmental
Protection
Agency
(
EPA)
has
completed
a
reregistration
eligibility
decision
(
RED)
for
the
pesticide
active
ingredient
propiconazole.
When
a
pesticide
is
eligible
for
reregistration,
EPA
explains
the
basis
for
its
decision
in
a
RED
document.
This
fact
sheet
summarizes
the
information
in
the
RED
document
for
the
pesticide
propiconazole,
case
number
3125.

All
pesticides
sold
or
distributed
in
the
United
States
must
be
registered
by
EPA,
based
on
scientific
studies
showing
that
they
can
be
used
without
posing
unreasonable
risks
to
people
or
the
environment.
Because
of
advances
in
scientific
knowledge,
the
law
requires
that
pesticides
first
registered
before
November
1,
1984,
be
reregistered
to
ensure
that
they
meet
today's
more
stringent
standards.

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

Regulatory
History
and
Background
 
Propiconazole
was
first
registered
in
1981.
 
Propiconazole
belongs
to
a
group
of
pesticides
called
triazoles
(
or
conazoles),
which
also
includes
the
triazole
fungicides
subject
to
reregistration,
triadimefon,
and
triadimenol.
The
triazole
fungicides
share
common
metabolites,
the
free
triazole
compounds
1,2,4­
triazole,
triazole
alanine,
and
triazole
acetic
acid,
which
are
considered
in
the
Agency's
assessments.
 
EPA
has
concluded
that
propiconazole
does
not
share
a
common
mechanism
of
toxicity
with
other
substances.

Uses
 
Propiconazole
is
a
fungicide
and
antimicrobial
used
to
control
various
bacteria,
fungi,
and
viruses,
including
plant
pathogens
and
spoilage
agents.
 
Propiconazole
is
used
on
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.
2
 
Approximately
345,000
pounds
of
propiconazole
active
ingredient
(
ai)
were
used
annually
from
1999
to
2004.
 
Propiconazole
is
not
a
Restricted
Use
Pesticide
Health
Effects
 
The
liver
is
the
target
organ
for
propiconazole.
Effects
observed
in
multiple
studies
across
species
include
liver
lesions,
increased
liver
weight,
ballooned
liver
cells,
and
foci
of
enlarged
hepatocytes.
There
were
also
increased
incidences
of
rudimentary
ribs
and
cleft
palate
malformations
noted
in
rat
and
rabbit
studies.
 
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.

Ecological
Effects
 
Propiconazole
is
classified
as
practically
non­
toxic
to
birds
and
mammals
on
an
acute
basis.
 
On
an
acute
basis,
propiconazole
is
classified
as
highly
toxic
to
freshwater
fish
and
classified
as
slightly
toxic
to
freshwater
invertebrate.
 
On
an
acute
basis,
propiconazole
is
classified
as
moderately
toxic
to
estuarine/
marine
fish
and
classified
as
highly
toxic
to
estuarine/
marine
invertebrate.
 
Propiconazole
showed
low
toxicity
to
plants.
Athough
several
species
of
monocots
and
dicots
were
tested
for
effects
of
propiconazole
on
seedling
emergence
and
vegetative
vigor,
effects
were
noted
in
only
a
few
species.

Risk
Summary
Human
Health
Risks­
 
Human
health
acute,
short­
term,
and
chronic
aggregate
risks
for
propiconazole
are
below
the
Agency's
level
of
concern.
This
includes
risks
from
dietary
exposure
to
residues
in
food
and
water,
as
well
as
residential
risks.

Occupational
Risks­
 
For
liquid
formulations,
handler
risks
for
most
scenarios
are
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
chemical­
resistant
gloves.
 
For
wettable
powder
formulations,
handler
risks
are
not
of
concern
provided
that
all
products
are
packaged
in
water­
soluble
bags.
 
Worker
risks
are
of
concern
for
workers
applying
paint
containing
propiconazole
as
an
incan
preservative;
however,
these
risks
are
mitigated
if
the
percent
active
ingredient
is
reduced.
 
There
are
no
re­
entry
risk
of
concern,
provided
workers
comply
with
a
12
hour
restricted
entry
interval
(
REI).
3
Ecological
Risks­
 
Acute
and
chronic
mammalian
risk
quotients
(
RQs)
for
propiconazole
are
below
the
Agency's
level
of
concern
(
LOC)
for
all
propiconazole
uses
except
turf.
 
Avian
acute
RQs
only
exceed
the
Agency's
LOC
of
0.5
for
turf
and
ornamental
uses,
when
the
smallest
weight
class
of
birds
feed
on
short
grass
following
multiple
propiconazole
applications.
Avian
chronic
RQs
exceed
the
LOC
for
turf
and
groundcover
for
all
weight
classes
of
birds
feeding
on
short
grass.
 
Propiconazole
poses
a
potential
risk
to
terrestrial
plants
for
some
uses.
 
The
Agency's
screening­
level
risk
assessment
shows
that
RQs
for
both
freshwater
and
estuarine/
marine
fish
do
not
exceed
the
acute
LOC
for
any
use,
but
exceed
the
listed
species
LOC
for
the
rice
use.
 
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
nonvascular
plants;
the
listed
species
RQs
exceed
the
LOC
of
1.

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

 
Handlers
mixing
and
loading
liquid
formulations
of
propiconazole
for
agricultural
use
must
wear
chemical­
resistant
gloves;
 
Handlers
applying
liquid
formulations
of
propiconazole
using
hand­
held
equipment
must
wear
chemical­
resistant
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%
ai;
and
 
Label
restrictions
to
minimize
spray
drift,
including
restrictions
on
droplet
size
and
application
height.

Regulatory
Conclusion
EPA
has
determined
that
all
supported
uses
of
propiconazole
are
eligible
for
reregistration,
provided
that
registrants
implement
risk
mitigation
measures
described
in
the
RED
and
make
required
changes
to
product
labeling.

Because
the
technical
registrants
have
requested
that
their
registration
be
amended
to
delete
use
of
propiconazole
on
apparel,
carpet
fibers,
and
home
furnishings
following
uses,
these
uses
were
not
considered,
and
are
not
eligible
for
reregistration:
EPA
issued
a
formal
order
deleting
these
uses
on
May
26,
2006.
4
Additional
Data
Requirements
EPA
is
requiring
the
following
additional
generic
studies
for
propiconazole
to
confirm
the
conclusions
of
this
propiconazole
RED
decision:

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)
5
For
More
Information
Electronic
copies
of
the
Propiconazole
RED
and
all
supporting
documents
are
available
in
Docket
#
EPA­
HQ­
OPP­
2005­
0497
at
http://
www.
regulations.
gov.
For
more
information
about
EPA's
pesticide
reregistration
program,
the
Propiconazole
RED,
or
reregistration
of
individual
products
containing
propiconazole,
please
contact
the
Special
Review
and
Reregistration
Division
(
7508P),
Office
of
Pesticide
Programs,
US
EPA,
Washington,
DC
20460,
telephone
703­
308­
8000.

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