[
Federal
Register:
February
27,
2004
(
Volume
69,
Number
39)]
[
Page
9315­
9320]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr27fe04­
51]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP­
2004­
0053;
FRL­
7346­
7]

Propiconazole;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Notice.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
This
notice
announces
the
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
to
extend
the
tolerances
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.

DATES:
Comments,
identified
by
docket
ID
number
OPP­
2004­
0053,
must
be
received
on
or
before
March
29,
2004.

ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Mary
L.
Waller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460­
0001;
telephone
number:
(
703)
308­
9354;
e­
mail
address:
waller.
mary@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
<
BULLET
Crop
production
(
NAICS
111)
<
BULLET
Animal
production
(
NAICS
112)
<
BULLET
Food
manufacturing
(
NAICS
311)
<
BULLET
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP­
2004­
0053.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305­
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
  
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.

An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
  
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.

[[
Page
9316]]

Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
to
Whom
Do
I
Submit
Comments?

You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
  
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­
mail
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD­
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD­
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
,
and
follow
the
online
instructions
for
submitting
comments.

Once
in
the
system,
select
  
search,''
and
then
key
in
docket
ID
number
OPP­
2004­
0053.
The
system
is
an
  
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP­
2004­
0053.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
  
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD­
ROM.
You
may
submit
comments
on
a
disk
or
CD­
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460­
0001,
Attention:
Docket
ID
Number
OPP­
2004­
0053.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP­
2004­
0053.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?

Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD­
ROM,
mark
the
outside
of
the
disk
or
CD­
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD­
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD­
ROM,
mark
the
outside
of
the
disk
or
CD­
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
[[
Page
9317]]

assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
pesticide
petitions
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
February
20,
2004.
Kathy
S.
Monk,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petitions
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Syngenta
Crop
Protection,
Inc.

PP
8F3654
and
PP
8F3674
EPA
has
received
pesticide
petitions
(
PP
8F3654
and
PP
8F3674)
from
Syngenta
Crop
Protection,
Inc.,
P.
O.
Box
18300,
Greensboro,
NC
27419­
8300
proposing,
pursuant
to
section
408(
d)
of
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.434
by
extending
the
time­
limited
tolerances
for
residues
of
propiconazole
(
1­[[
2­(
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole)
in
or
on
corn,
field,
forage
at
12
parts
per
million
(
ppm);
corn,
field,
grain
at
0.1
ppm;
corn,
field,
stover
at
12
ppm;
corn,
sweet,
kernel
plus
cob
with
husks
removed
at
0.1
ppm;
pineapple
at
0.1
ppm;
pineapple,
fodder
at
0.1
ppm
(
8F3674);
peanuts
at
0.2
ppm;
and
peanuts,
hay
at
20
ppm
(
8F3654).

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
propiconazole
as
well
as
the
nature
of
the
residues
is
adequately
understood
for
purposes
of
the
tolerances.
Plant
metabolism
has
been
evaluated
in
five
diverse
crops,
wheat,
grapes,
celery,
peanuts
and
carrots
which
should
serve
to
define
the
similar
metabolism
of
propiconazole
in
a
wide
range
of
crops.
The
plant
metabolism
pathway
for
propiconazole
is
well
understood.
Parent
metabolite
CGA­
64250
is
the
major
compound
found
in
crops.
Comparison
of
the
metabolism
of
propiconazole
in
different
plant
species
shows
that
the
differences
between
the
respective
metabolic
pathways
to
be
quantitative
in
nature.
2.
Analytical
method.
The
metabolism
data
in
plants
and
animals
suggest
that
analytical
methods
to
detect
either
the
phenyl
or
the
triazole
ring
would
be
appropriate
for
the
measurement
of
residues.
However,
because
of
the
natural
occurrence
of
compounds
that
interfere
with
the
measurement
of
triazoles,
methods
designed
to
detect
this
moiety
have
been
proven
unreliable
and
unacceptable.
Conversely,
conversion
of
phenyl
moiety
to
2,4­
dichlorobenzoic
acid
(
DCBA)
has
proven
to
be
satisfactory
for
all
agricultural
products
analyzed
to
date.
Analytical
method
AG­
454A
was
developed
for
the
determination
of
residues
of
propiconazole
and
its
metabolites
containing
the
DCBA
moiety.
This
method
has
been
accepted
and
published
by
EPA
as
the
tolerance
enforcement
method
for
crops.
The
limit
of
quantitation
(
LOQ)
for
the
method
is
0.05
ppm.
3.
Magnitude
of
residues.
Field
residue
trials
have
been
conducted
at
various
rates,
timing
intervals,
and
applications
methods
to
represent
the
use
patterns
which
would
most
likely
result
in
the
highest
residues.
For
all
samples,
the
total
residue
method
was
used
for
determination
of
the
combined
residues
of
parent
and
its
metabolites
which
contain
the
DCBA
moiety.

B.
Toxicological
Profile
1.
Acute
toxicity.
Propiconazole
exhibits
low
toxicity.
Data
indicated
the
following:
A
rat
acute
oral
lethal
dose
(
LD)
50
of
1,517
milligrams/
kilogram
(
mg/
kg);
a
rabbit
acute
dermal
LD50
>
6,000
mg/
kg;
a
rat
inhalation
lethal
concentration
(
LC)
50
>
5.8
mg/
liter
air;
minimal
skin
and
slight
eye
irritation;
and
nonsensitization.
2.
Genotoxicty.
Propiconazole
exhibits
no
mutagenic
potential
based
on
the
following
data:
In
vitro
gene
mutation
test
(
Ames
assay,
rat
hepatocyte
DNA
repair
test,
(
human
fibroblast
DNA
repair
test);
in
vitro
chromosome
test,
(
human
lymphocyte
cytogenetic
test);
in
vivo
mutagenicity
test,
(
Chinese
hamster
bone
marrow
cell
nucleus
anomaly
test,
Chinese
hamster
bone
marrow
cell
micronucleus
test,
mouse
dominant
lethal
test);
and
other
mutagenicity
test
(
BALB/
3T3
cell
transformation
assay).
3.
Reproductive
and
developmental
toxicity.
In
an
oral
teratology
study
in
the
rabbit,
a
maternal
no
observed
adverse
effect
level
(
NOAEL)
of
30
mg/
kg
was
based
on
reduced
food
intake
but
without
any
fetotoxicity
even
at
the
top
dose
of
180
mg/
kg.
In
an
oral
teratology
study
in
the
rabbit,
a
maternal
NOAEL
of
100
mg/
kg
was
based
on
reductions
in
body
weight
gain
and
food
consumption
and
a
fetal
NOAEL
of
250
mg/
kg
was
based
on
increased
skeletal
variations
at
400
mg/
kg.
In
an
oral
teratology
study
in
the
rat,
a
maternal
and
fetal
NOAEL
of
100
mg/
kg
was
based
on
decreased
survival,
body
weight
gain,
and
food
consumption
in
the
dams
and
delayed
ossification
in
the
fetuses
at
300
mg/
kg.
In
a
second
teratology
study
in
the
rat,
a
maternal
and
fetal
NOAEL
of
30
mg/
kg
was
based
on
reductions
in
body
weight
gain
and
food
consumption
in
the
dams
and
delayed
development
in
the
fetuses
at
90
and
360/
300
mg/
kg.
A
supplemental
teratology
study
in
the
rat
involving
eight
times
as
many
animals
per
group
as
usually
required
showed
no
teratogenic
potential
for
the
compound.
A
2­
generation
reproduction
study
in
the
rat
showed
excessive
toxicity
at
5,000
ppm
without
any
teratogenic
effects.
A
2­
generation
reproduction
study
in
the
rat
showed
no
effects
on
reproductive
or
fetal
parameters
at
any
dose
level.
Postnatal
growth
and
survival
were
affected
at
the
top
dose
of
2,500
ppm,
and
parental
toxicity
was
also
evident.
The
NOAEL
for
development
toxicity
is
500
ppm.
4.
Subchronic
toxicity.
In
a
21­
day
dermal
study
in
the
rabbit,
a
NOAEL
of
200
mg/
kg
was
based
on
clinical
signs
of
systemic
toxicity.
In
a
28­
day
oral
toxicity
study
in
the
rat,
a
NOAEL
of
50
mg/
kg
was
based
on
increased
liver
weight.
In
a
subchronic
feeding
study
in
the
mouse,
a
NOAEL
of
20
ppm
(
3
mg/
kg)
was
based
on
liver
pathologic
changes.
In
a
13­
week
feeding
study
in
the
male
mouse,
a
NOAEL
of
20
ppm
(
3
mg/
kg)
was
based
on
liver
pathologic
changes.
In
a
90­
day
feeding
study
in
rats,
the
NOAEL
was
240
ppm
(
24
mg/
kg)
based
on
a
reduction
in
body
weight
gain.
In
a
90­
day
feeding
study
in
dogs,

[[
Page
9318]]
the
NOAEL
was
250
ppm
(
6.25
mg/
kg)
based
on
reduced
food
intake
and
stomach
histologic
changes.
5.
Chronic
feeding
toxicity
and
carcinogenicity.
In
a
12­
month
feeding
study
in
the
dog,
a
NOAEL
of
50
ppm
(
1.25
mg/
kg)
was
based
on
stomach
histologic
changes.
In
a
24­
month
oncogenicity
feeding
study
in
the
mouse,
the
NOAEL
was
100
ppm
(
15
mg/
kg).
The
maximum
tolerated
dose
(
MTD)
was
exceeded
at
2,500
ppm
in
males
based
on
decreased
survival
and
body
weight.
Increased
incidence
of
liver
tumor
was
seen
in
these
males
but
no
evidence
of
carcinogenicity
was
seen
at
the
next
lower
dose
of
500
ppm
in
either
sex.
In
a
24­
month
chronic
feeding/
oncogenicity
study
in
the
rat,
a
NOAEL
of
100
ppm
(
5
mg/
kg)
was
based
on
body
weight
and
blood
chemistry.
The
MTD
was
2,500
ppm
based
on
reduction
in
body
weight
gain
and
no
evidence
of
oncogenicity
was
seen.
Based
on
the
available
chronic
toxicity
data,
Syngenta
believes
the
reference
dose
(
RfD)
for
propiconazole
is
0.0125
mg/
kg/
day.
This
RfD
is
based
on
a
1
year
feeding
study
in
dogs
with
a
NOAEL
of
1.25
mg/
kg/
day
(
50
ppm)
and
an
uncertainly
factor
of
100.
No
additional
modifying
factor
for
the
nature
of
effects
was
judged
to
be
necessary
as
stomach
mucous
hyperemia
was
the
most
sensitive
indicator
of
toxicity
in
that
study.
Using
the
  
Guidelines
for
Carcinogenic
Risk
Assessment''
published
on
September
24,
1986
(
51
FR
33992),
EPA
has
classified
propiconazole
in
Group
C
for
carcinogenicity
(
evidence
of
possible
carcinogenicity
for
humans).
The
compound
was
tested
in
24­
month
studies
with
both
rats
and
mice.
The
only
evidence
of
carcinogenicity
was
an
increase
in
liver
tumor
incidence
in
male
mice
at
a
dose
level
that
exceeded
the
MTD.
Dosage
levels
in
the
rat
study
were
appropriate
for
identifying
a
cancer
risk.
The
Cancer
Peer
Review
Committee
recommended
the
RfD
approach
for
quantitation
of
human
risk.
Therefore,
the
RfD
is
deemed
protective
of
all
chronic
human
health
effects,
including
cancer.
6.
Animal
metabolism.
Metabolism
in
animals
is
similar
to
plant
metabolism.
In
animals
both
the
rat
and
the
goat
rapidly
metabolize
and
excrete
propiconazole.
Neither
animal
retains
significant
amounts
of
propiconazole
or
its
metabolites
in
tissues.
Significant
quantities
of
parent
or
metabolites
do
not
appear
in
goat's
milk.
Similar
metabolites
are
produced
by
both
species,
and
unconjugated
(
Phase
I)
metabolites
are
similar
in
plants
and
animals.
The
metabolism
profile
supports
the
use
of
an
analytical
enforcement
method
that
accounts
for
combined
residues
of
propiconazole
and
its
metabolites
that
contain
the
DCBA
moiety.
7.
Metabolite
toxicology.
There
are
no
metabolites
of
concern
based
on
a
differential
metabolism
between
plants
and
animals.
8.
Endocrine
disruption.
Developmental
toxicity
studies
in
rats
and
rabbits
and
reproduction
studies
in
rats
gave
no
indication
that
propiconazole
might
have
any
effects
on
endocrine
function
related
to
development
and
reproduction.
The
subchronic
and
chronic
studies
also
showed
no
evidence
of
a
long­
term
effect
related
to
the
endocrine
system.
Further,
due
to
the
moderate
rate
of
degradation
of
the
product,
there
is
no
risk
that
propiconazole
may
accumulate
in
the
environment.
In
animals,
propiconazole
is
quickly
excreted
and
has
no
tendency
for
accumulation
in
the
body.
Based
on
these
results,
it
is
very
likely
that
propiconazole
has
no
potential
to
interfere
specifically
with
the
endocrine
system.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Tier
III/
IV
acute
and
chronic
dietary
exposure
evaluations
were
completed
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM\
TM\),
version
7.87
from
Exponent.
All
consumption
data
for
these
assessments
was
taken
from
the
U.
S.
Department
of
Agriculture's
Continuing
Survey
of
Food
Intake
by
Individuals
(
CSFII)
with
the
1994­
1996
consumption
data
base
and
the
Supplemental
CSFII
Children's
Survey
(
1998)
consumption
data
base.
These
exposure
assessments
included
all
registered
crop
uses
(
almonds,
apricots,
bananas,
barley,
blueberries,
celery,
cherries,
corn
(
field),
corn
(
sweet),
cranberries,
dry
beans
and
peas,
filberts
(
hazelnuts),
grasses
grown
for
seed,
nectarines,
oats,
peaches,
peanuts,
pecans,
peppermint,
pineapples,
plums,
prunes,
raspberries,
rice,
rye,
spearmint,
sorghum,
sugar
cane,
wheat
and
wild
rice).
Empirically
derived
processing
studies
for
peanut
oil
(
0.37X),
sorghum
aspirated
grain
fractions
(
5.21X),
spearmint
oil
(
0.66X),
and
sorghum
flour
(
0.23X)
were
used
in
these
assessments.
All
other
processing
factors
used
DEEM\
TM\
defaults.
Secondary
residues
in
animal
commodities
were
estimated
based
on
theoretical
worst­
case,
yet
nutritionally
adequate
animal
diets
and
residue
transfer
factors
calculated
from
feeding
studies.
a.
Food.
For
the
purposes
of
assessing
the
potential
dietary
exposures
under
the
current
tolerances,
Syngenta
estimated
aggregate
exposures
from
all
crops
for
which
tolerances
are
established.
These
assessments
utilized
residue
data
from
field
trials
where
propiconazole
was
applied
at
the
maximum
intended
use
rate
and
samples
were
harvested
at
the
minimum
pre­
harvest
interval
(
PHI)
to
obtain
maximum
residues.
In
these
Tier
III/
IV
dietary
exposure
assessments,
Syngenta
Market
Basket
Survey
residue
data
was
used
for
the
following
commodities:
Bananas,
celery,
sweet
corn,
cherries,
peaches,
peanut
butter
and
wheat
flour.
Percent
of
crop
treated
(%
CT)
values
were
based
on
Doane's
2001
data
base.
Since
percent
crop
treated
is
inherent
in
the
market
basket
data,
no
percent
crop
treated
correction
was
used
for
commodities
analyzed
in
the
Syngenta
Market
Basket
Survey.
i.
Acute
exposure.
An
acute
reference
dose
of
0.30
mg/
kg
bwt/
day
for
the
females
13­
50
years
subpopulation
only
was
based
on
a
NOAEL
of
30
mg/
kg
bwt/
day
from
a
rat
developmental
toxicity
study
and
an
uncertainly
factor
of
100X.
The
100­
fold
safety
factor
includes
intraspecies
and
interspecies
variations.
No
additional
FQPA
safety
factor
was
applied.
Acute
exposure
to
the
females
13­
50
years
subpopulation
was
expressed
as
a
percent
of
the
acute
RfD.
Acute
dietary
exposure
to
females
13­
50
years
old
at
the
99.9th
percentile
of
exposures
was
negligible
(
0.3%
of
the
acute
RfD
of
0.30
mg/
kg
body
weight/
day).
Since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
dietary
(
food)
exposure
to
residues
arising
from
the
current
uses
of
propiconazole.
ii.
Chronic
exposure.
The
chronic
reference
dose
(
RfD)
of
propiconazole
is
0.0125
mg/
kg
bwt/
day
and
is
based
on
a
chronic
dog
feeding
study
with
a
NOAEL
of
1.25
mg/
kg
bwt/
day
and
an
uncertainly
factor
of
100X.
The
100­
fold
safety
factor
includes
intraspecies
and
interspecies
variations.
No
additional
FQPA
safety
factor
was
applied.
Exposures
were
expressed
as
a
percent
of
the
chronic
RfD.
Chronic
exposure
to
the
most
exposed
subpopulation
(
children
1
and
2
years
old)
was
0.5%
of
the
chronic
RfD
of
0.0125
mg/
kg
bwt/
day.
Since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
dietary
(
food)
exposure
to
residues
arising
from
the
current
uses
of
propiconazole.
b.
Drinking
water.
EPA
uses
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
[[
Page
9319]]

estimate
pesticide
concentrations
in
surface
water
and
Screening
Concentration
in
Ground
Water
(
SCI­
GROW)
to
predict
pesticide
concentrations
in
ground
water.
None
of
these
models
include
consideration
of
the
impact
processing
of
raw
water
(
mixing,
dilution,
or
treatment)
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
conservative
approximation
of
the
estimated
environmental
concentration
(
EEC)
of
specific
pesticides
in
drinking
water.
The
highest
use
rate
for
propiconazole
is
on
turf;
therefore,
this
use
was
evaluated
to
assess
the
potential
environmental
exposure
to
drinking
water.
For
ground
water
(
SCI­
GROW)
modeling,
Syngenta
has
determined
that
EECs
of
propiconazole
at
the
highest
use
rate
(
1.77
pound/
active
ingredient/
acre
x
4
applications,
turf
use)
are
1.48
parts
per
billion
(
ppb)
for
both
acute
and
chronic
exposure.
Using
the
same
propiconazole
use
rate
for
surface
water
(
PRZM/
EXAMS)
modeling,
acute
and
chronic
EECs
were
4.69
ppb
and
2.99
ppb,
respectively.
EECs
of
propiconazole
are
compared
to
the
acute
and
chronic
Drinking
Water
Levels
of
Comparison
(
DWLOC).
Since
the
surface
water
EECs
exceed
the
ground
water
EECs,
the
surface
water
values
will
be
used
for
comparison
purposes
and
will
be
considered
protective
for
any
ground
water
concentration
concerns.
i.
Chronic
risk.
DWLOCs
were
calculated
based
on
a
chronic
Population
Adjusted
Dose
(
PAD)
of
0.013
mg/
kg/
day.
Chronic
drinking
water
exposure
represents
2.3%
of
the
chronic
PAD
for
a
10
kg
child
consuming
1
L
water/
day.
The
children
1
to
2
years
subpopulation
generated
the
lowest
chronic
DWLOC
of
129
ppb.
Since
the
chronic
DWLOC
of
129
ppb
is
considerably
higher
than
the
chronic
EEC
of
2.99
ppb,
EPA
should
not
have
a
concern
for
chronic
risk
to
either
surface
water
or
ground
water.
ii.
Acute
risk.
The
acute
DWLOC
was
calculated
based
on
an
acute
PAD
of
0.30
mg/
kg/
day.
Acute
drinking
water
exposure
represents
0.05%
of
the
acute
PAD
for
a
60
kg
female
consuming
2
L
water/
day.
The
females
13
years
and
older
subpopulation
is
the
only
subgroup
of
concern
and
generated
an
acute
DWLOC
of
8,972
ppb.
Since
the
acute
DWLOC
of
8,972
ppb
is
considerably
higher
than
the
acute
EEC
of
4.69
ppb,
EPA
should
not
have
a
concern
for
acute
risk
to
either
surface
water
or
ground
water.
2.
Non­
dietary
exposure.
Propiconazole
is
registered
for
residential
use
as
a
preservative
treatment
for
wood
and
for
lawn
and
ornamental
uses.
At
this
time,
no
reliable
data
exist
which
would
allow
quantitative
incorporation
of
risk
from
these
uses
into
a
human
health
risk
assessment.
The
exposure
to
propiconazole
from
contacting
treated
wood
products
is
anticipated
to
be
very
low
since
the
surface
of
wood
is
usually
coated
with
paint
or
sealant
when
used
in
or
around
the
house.
The
non­
occupational
exposure
from
lawn
and
ornamental
applications
is
also
considered
to
be
minor.
It
is
estimated
that
less
than
0.01%
of
all
households
nationally
use
propiconazole
in
a
residential
setting.
3.
Aggregate
exposure.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
supporting
these
petitions,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
residues
arising
from
current
propiconazole
uses,
including
anticipated
dietary
exposure
from
food,
water,
and
all
other
types
of
non­
occupational
exposures.

D.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
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.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
propiconazole
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
For
the
purposes
of
this
tolerance
action,
EPA
has
not
assumed
that
propiconazole
has
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
The
dietary
exposure
assessment
for
propiconazole
showed
that
there
were
acceptable
safety
margins
with
respect
to
both
chronic
and
acute
exposure
through
the
dietary
consumption
of
propiconazole­
treated
commodities.
The
most
sensitive
subpopulation
was
children
(
1­
2
years
old)
with
a
chronic
exposure
of
0.5%
of
the
chronic
reference
dose
of
0.0125
mg/
kg
bwt/
day.
Females
13
years
and
older
is
the
only
population
subgroup
of
concern
for
the
acute
dietary
exposure
assessment.
Dietary
exposure
to
females
(
13­
50
years
old)
at
the
99.9th
percentile
of
exposure
was
negligible
(
0.3%
of
the
acute
RfD
of
0.30
mg/
kg
bwt/
day).
EPA
has
determined
that
reliable
data
support
using
the
standard
MOE
and
uncertainty
factor
(
100
for
combined
interspecies
and
intraspecies
variability)
for
propiconazole
and
that
an
additional
safety
of
10
is
not
necessary
to
be
protective
of
infants
and
children.
For
the
drinking
water
portion
of
the
aggregate
assessment,
the
EECs
of
propiconazole
in
surface
water
were
greater
than
those
for
ground
water.
Surface
water
EECs
were
4.69
ppb
and
2.99
ppb
for
acute
and
chronic
exposure,
respectively.
The
chronic
DWLOC
was
calculated
as
129
ppb
for
the
most
sensitive
subgroup,
children
(
1­
2
years
old).
For
the
acute
assessment,
the
females
13
years
and
older
subpopulation
is
the
only
subgroup
of
concern
and
provided
an
acute
DWLOC
of
8,972
ppb.
Since
both
chronic
and
acute
EECs
were
well
below
the
chronic
and
acute
DWLOCs,
there
should
be
no
concern
for
acute
risk
from
either
surface
water
or
ground
water.
Exposure
from
non­
food
sources,
residential
and
lawn
applications
of
propiconazole
products,
is
considered
to
be
negligible.
Based
upon
the
current
chronic
and
acute
aggregate
exposure
analysis,
aggregate
exposures
are
below
100%
of
the
chronic
and
acute
reference
doses.
The
worst­
case
chronic
food
exposure
for
children
1­
2
years
old
represents
0.5%
of
the
chronic
RfD
of
0.0125
mg/
kg
bwt/
day.
The
worst­
case
chronic
drinking
water
exposure
for
children
1­
2
years
old
(
based
upon
surface
water
modeling)
represents
2.3%
of
the
chronic
reference
dose.
Since
the
residential
exposure
for
propiconazole
is
negligible,
the
worstcase
aggregate
chronic
risk
(
food
plus
drinking
water)
is
approximately
3%.
The
worst­
case
aggregate
acute
risk
(
food
plus
drinking
water)
to
females
(
13­
50
years
old)
at
the
99.9th
percentile
of
exposure
is
negligible
(
0.3%
of
the
acute
RfD
of
0.30
mg/
kg
bwt/
day).
Syngenta
has
considered
the
potential
aggregate
exposure
from
food,
water
and
non­
occupational
exposure
routes
and
concluded
that
aggregate
exposure
is
not
expected
to
exceed
100%
of
the
chronic
and
acute
RfDs
and
there
is
a
reasonable
certainty
that
no
harm
will
result
to
any
populations
subgroups,
including
infants
and
children,
from
the
aggregate
exposure
to
propiconazole.

F.
International
Tolerances
International
CODEX
values
are
established
for
almond,
animal
products,
bananas,
barley,
coffee,
eggs,
grapes,
mango,
meat,
milk,
oat,
peanut­
whole,
peanut
grains,
pecans,
rape,
rye,
stone
fruit,
sugar
cane,
sugar
beets,
sugar
beet
tops,
and
wheat.
The
U.
S.

[[
Page
9320]]
residue
definition
includes
both
propiconazole
and
metabolites
determined
as
2,4­
dichlorobenzoic
acid
(
DCBA),
while
the
CODEX
definition
is
for
propiconazole,
per
se,
i.
e.
parent
only.
This
difference
results
in
unique
tolerance
expressions
with
the
U.
S.
definition
resulting
in
the
higher
tolerance
levels.
[
FR
Doc.
E4­
416
Filed
2­
26­
04;
8:
45
am]

BILLING
CODE
6560­
50­
S
