Document ID: EPA-HQ-OPP-2003-0273-0001
Agency: epa
Document Type: Notice
Title: Dimethomorph; Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemical in or on Food
Posted Date: 2003-08-20T04:00Z

50138
Federal
Register
/
Vol.
68,
No.
161
/
Wednesday,
August
20,
2003
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0262;
FRL
 
7321
 
7]

Dimethomorph;
Notice
of
Filing
Pesticide
Petitions
to
Establish
Tolerances
for
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
pesticide
petitions
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0262,
must
be
received
on
or
before
September
19,
2003.

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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
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:
 
Industry
(
NAICS
111)
 
Crop
production
(
NAICS
112)
 
Animal
production
(
NAICS
311)
 
Food
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
ID
number
OPP
 
2003
 
0262.
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
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.
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
on
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
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also,
include
this
contact
information
on
the
outside
of
any
disk
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Register
/
Vol.
68,
No.
161
/
Wednesday,
August
20,
2003
/
Notices
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
 
2003
 
0262.
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
 
2003
 
0262.
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
 
2003
 
0262.
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
 
2003
 
0262.
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
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
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
this
petition
contains
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
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

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

Dated:
August
11,
2003.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
were
prepared
by
BASF
Corporation
and
represents
the
view
of
BASF
Corporation.
The
petition
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.

Interregional
Research
Project
Number
4
(
IR­
4)

PP
2E6483
and
PP
3E6558
EPA
has
received
pesticide
petitions
(
2E6483
and
3E6558)
from
Interregional
Research
Project
Number
4
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.493
by
establishing
tolerances
for
residues
of
dimethomorph,
(
E,
Z)
4­[
3­(
4­
chlorophenyl)­
3­(
3,4­
dimethoxyphenyl)­
1­
oxo­
2­
propenyl
morpholine
in
or
on
the
following
raw
agricultural
commodities:
Vegetable,
fruiting,
group
8
at
2.0
parts
per
million
(
ppm)
(
2E6483),
brassica,
leafy,
greens,

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Register
/
Vol.
68,
No.
161
/
Wednesday,
August
20,
2003
/
Notices
(
subgroup
5B),
and
turnip,
tops
at
20
ppm
(
PP
3E6558),
taro,
leaves
at
6.0
ppm
(
3E6558),
and
taro,
roots
at
0.5
ppm
(
3E6558).
IR­
4
also
proposes
to
delete
the
existing
tolerance
for
tomato,
fruit
at
0.5
ppm.
Tomato
is
included
in
the
proposed
tolerance
for
the
fruiting
vegetable
group
8
at
2.0
ppm.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
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.
This
summary
has
been
prepared
by
BASF
Corporation,
Research
Triangle
Park,
NC
27709.

A.
Residue
Chemistry
1.
Plant
metabolism.
Based
upon
the
results
of
metabolism
studies
conducted
on
potato,
grape,
and
lettuce,
the
nature
of
the
residues
in
plants
is
considered
to
be
understood.
2.
Analytical
method.
A
reliable
method
for
the
determination
of
dimethomorph
residues
in
fruiting
vegetables
(
except
cucurbits)
(
crop
group
8),
leafy
brassica
greens
(
subgroup
5B),
turnip
greens,
taro
leaves
and
roots
exists;
this
method
is
the
FDA
Multi­
Residue
Method,
Protocol
D,
as
published
in
the
Pesticide
Analytical
Manual
I.
3.
Magnitude
of
residues.
The
magnitude
of
residues
for
the
proposed
tolerances
are
adequately
understood.

B.
Toxicological
Profile
1.
Acute
toxicity
 
i.
Oral
lethal
dose
LD50
studies
were
conducted
on
dimethomorph
technical:
a.
An
acute
oral
toxicity
study
in
the
Sprague­
Dawley
rat
for
dimethomorph
technical
with
a
LD50
of
4,300
milligrams/
kilogram
body
weight
(
mg/
kg
bwt)
for
males
and
3,500
mg/
kg
bwt
for
females.
Based
upon
EPA
toxicity
criteria,
the
acute
oral
toxicity
category
for
dimethomorph
technical
is
Category
III
or
slightly
toxic.
b.
An
acute
toxicity
study
in
the
CD­
1
mouse
for
dimethomorph
technical
with
a
LD50
of
greater
than
5,000
mg/
kg
bwt
for
males
and
3,699
mg/
kg/
bwt
for
females.
Based
on
the
EPA
toxicity
category
criteria,
the
acute
oral
toxicity
category
for
dimethomorph
technical
is
Category
III
or
slightly
toxic.
ii.
Oral
LD50
studies
were
conducted
on
the
two
isomers
(
E
and
Z)
alone:
a.
An
acute
oral
toxicity
study
in
the
Wistar
rat
for
the
E­
isomer
with
a
LD50
greater
than
5,000
mg/
kg
bwt
for
males
and
approximately
5,000
mg/
kg
bwt
for
females.
b.
An
acute
oral
toxicity
study
in
the
Wistar
rat
for
the
Z­
isomer
with
a
LD50
greater
than
5,000
mg/
kg
bwt
for
both
males
and
females.
iii.
An
acute
dermal
toxicity
study
in
the
Wistar
rat
for
dimethomorph
technical
with
a
dermal
LD50
greater
than
5,000
mg/
kg
bwt
for
both
males
and
females.
Based
on
the
EPA
toxicity
category
criteria,
the
acute
dermal
toxicity
category
for
dimethomorph
is
Category
IV
or
relatively
non­
toxic.
iv.
A
4
 
hour
inhalation
study
in
Wistar
rats
for
dimethomorph
technical
with
a
lethal
concentration
LC50
greater
than
4.2
milligram
per
liter
(
mg/
L)
for
both
males
and
females.
Based
on
the
EPA
toxicity
category
criteria,
the
acute
inhalation
toxicity
category
for
dimethomorph
technical
is
Category
IV
or
relatively
non­
toxic.
v.
A
skin
irritation
study
was
performed
using
New
Zealand
White
rabbits.
Based
on
EPA's
toxicity
criteria,
the
skin
irritation
toxicity
category
for
dimethomorph
technical
in
this
study
is
Category
IV
or
non­
to­
slightly
irritating.
vi.
An
eye
irritation
study
using
New
Zealand
white
rabbits
demonstrated
dimethomorph
technical
produced
moderate
conjunctival
redness,
slight
to
moderate
chemosis
and
slight
discharge
3
hours
after
treatment.
Based
on
EPA's
toxicity
criteria,
the
eye
toxicity
category
for
dimethomorph
technical
is
Category
III
(
slightly
to
moderately
irritating).
2.
Genotoxicity.
 
i.
Salmonella
reverse
gene
mutation
assays
(
2
studies)
were
negative
up
to
a
limit
dose
of
5,000
g/
plate.
Chinese
hamster
lung
V79
cells
were
negative
for
mutations
at
the
HGPRT
locus
at
up
to
toxic
doses
in
two
studies.
ii.
Two
Chinese
hamster
lung
(
V79
cells)
structural
chromosomal
studies
were
reportedly
positive
for
chromosomal
aberrations
at
the
highest
dose
tested
(
HDT)
(
160
g/
ml/­
S9;
170
g/
ml/+
S9).
However,
dimethomorph
induced
only
a
weak
response
in
increasing
chromosome
aberrations
in
this
test
system.
In
addition,
these
results
were
not
confirmed
in
two
micronucleus
tests
under
in
vivo
conditions.
iii.
Structural
chromosomal
aberration
studies
were
weakly
positive
in
human
lymphocytic
cultures,
but
only
in
S9
activated
cultures
treated
at
422
g/
mL,
the
HDT,
which
was
strongly
cytotoxic.
No
increase
in
chromosomal
aberrations
was
observed
in
the
absence
of
S9
activation
at
all
doses.
Furthermore,
the
positive
clastogenic
response
observed
under
the
in
vitro
conditions
was
not
confirmed
in
two
in
vivo
micronucleus
assays.
iv.
Micronucleus
assay
(
2
studies)
indicated
that
dimethomorph
was
negative
for
inducing
micronuclei
in
bone
marrow
cells
of
mice
following
i.
p.
administration
of
doses
up
to
200
mg/
kg
or
oral
doses
up
to
the
limit
dose
of
5,000
mg/
kg.
Thus,
dimethomorph
was
found
to
be
negative
in
these
studies
for
causing
cytogenic
damage
in
vivo.
v.
Dimethomorph
was
negative
for
inducing
unscheduled
DNA
synthesis,
in
cultured
rat
liver
cells,
at
doses
up
to
250
grams
per
milliliter
(
g/
ml),
a
weakly
cytotoxic
level.
vi.
Dimethomorph
was
negative
for
transformation
in
Syrian
hamster
embryo
cells
treated,
in
the
presence
and
absence
of
activation,
up
to
cytotoxic
concentrations
(
265
g/
mL/+
S9;
50
g/
mL/­
S9).
3.
Reproductive
and
developmental
toxicity
 
i.
A
rat
developmental
toxicity
study
with
a
lowest
observed
adverse
effect
level
(
LOAEL)
for
maternal
toxicity
of
160
mg/
kg/
day
and
a
NOAEL
for
maternal
toxicity
of
60
mg/
kg/
day.
The
NOAEL
for
developmental
toxicity
is
60
mg/
kg/
day.
Dimethomorph
is
not
teratogenic
in
the
Sprague­
Dawley
rat.
ii.
A
rabbit
development
toxicity
study
with
a
LOAEL
for
maternal
toxicity
of
650
mg/
kg/
day
and
a
NOAEL
for
maternal
toxicity
of
300
mg/
kg/
day.
The
NOAEL
for
developmental
toxicity
is
650
mg/
kg/
day,
the
HDT.
Dimethomorph
is
not
teratogenic
in
the
New
Zealand
white
rabbit.
iii.
A
two­
generation
rat
reproduction
study
with
a
LOAEL
for
parental
systemic
toxicity
of
1,000
ppm,
or
approximately
80
mg/
kg/
day,
and
a
NOAEL
for
parental
systemic
toxicity
of
300
ppm,
or
approximately
24
mg/
kg/
day.
The
NOAEL
for
fertility
and
reproductive
function
was
1,000
ppm,
the
highest
concentration
tested
(
HCT),
or
approximately
80
mg/
kg
bwt/
day.
4.
Subchronic
toxicity
 
i.
A
90
 
day
dietary
study
in
Sprague­
Dawley
rats
with
a
NOAEL
of
greater
than
or
equal
to
1,000
ppm,
the
HCT
tested,
or
approximately
73
mg/
kg/
day
for
males
and
82
mg/
kg/
day
for
females.
ii.
A
90
 
day
dog
dietary
study
with
a
NOAEL
of
450
ppm,
or
approximately
15
mg/
kg/
day,
and
a
LOAEL
of
1,350
ppm,
or
approximately
43
mg/
kg/
day.
5.
Chronic
toxicity
 
i.
A
2
 
year
chronic
toxicity
study
in
Sprague­
Dawley
rats
with
a
NOAEL
of
200
ppm
or
approximately
9
mg/
kg/
day
for
males
and
12
mg/
kg/
day
for
females.
The
LOAEL
for
systemic
toxicity
is
750
ppm,
or
approximately
36
mg/
kg/
day
for
males
and
58
mg/
kg/
day
for
females.
ii.
A
1
 
year
chronic
toxicity
study
in
dogs
with
a
NOAEL
of
450
ppm,
or
approximately
14.7
mg/
kg/
day
and
a
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20,
2003
/
Notices
LOAEL
of
1,350,
or
approximately
44.6
mg/
kg/
day.
iii.
A
2
 
year
oncogenicity
study
in
Sprague­
Dawley
rats
with
a
NOAEL
for
systemic
toxicity
of
200
ppm,
or
approximately
9
mg/
kg/
day
for
males
and
11
mg/
kg/
day
for
females.
The
LOAEL
for
systemic
toxicity
was
750
ppm,
or
approximately
34
mg/
kg/
day
for
males
and
46
mg/
kg/
day
for
females.
There
was
no
evidence
of
increased
incidence
of
neoplastic
lesions
in
treated
animals.
The
NOAEL
for
oncogenicity
is
2,000
ppm,
the
Highest
Concentration
Tested
(
HCT),
or
approximately
95
mg/
kg/
day
for
males
and
132
mg/
kg/
day
for
females.
iv.
A
2
 
year
oncogenicity
study
in
CD­
1
mice
with
a
NOAEL
for
systemic
toxicity
of
100
mg/
kg/
day
and
a
LOAEL
of
1,000
mg/
kg/
day.
There
was
no
evidence
of
increased
incidence
of
neoplastic
lesions
in
treated
animals.
The
NOAEL
for
oncogenicity
is
1,000
mg/
kg/
day,
the
HDT.
6.
Animal
metabolism.
Results
from
the
livestock
and
rat
metabolism
studies
show
that
orally
administered
dimethomorph
was
rapidly
excreted
by
the
animals.
The
principal
route
of
elimination
is
the
feces.
7.
Metabolite
toxicology.
There
were
no
metabolites
identified
in
plant
or
animal
commodities
which
require
regulation.
8.
Endocrine
disruption.
Collective
organ
weights
and
histopathological
findings
from
the
two­
generation
reproduction
study
in
rats,
as
well
as
from
the
subchronic
and
chronic
toxicity
studies
in
two
or
more
animal
species,
demonstrate
no
apparent
estrogenic
effects
or
effects
on
the
endocrine
system.
There
is
no
information
available
which
suggests
that
dimethomorph
technical
would
be
associated
with
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure.
The
CARES
1.1
model
with
the
CSFII/
FCID
consumption
data
were
used
to
calculate
chronic
and
acute
exposure
estimates.
Result
exposure
estimates
99.9th
percentile
were
compared
against
the
dimethomorph
reference
dose
(
RfD)
and
chronic
population
adjusted
dose
(
cPAD).
i.
Food.
The
dietary
assessment
analysis
followed
an
initial
tier
approach
with
only
one
minor
refinement.
Tolerance
values,
default
processing
factors,
and
100%
crop
treated
(
CT)
values
were
assumed
in
the
assessment.
The
only
minor
refinement
was
including
percent
crop
treated
values
for
potatoes
(
2.2%),
tomatoes
(
0.1%),
cucumbers
(
2.9%),
and
pumpkin
(
13.6%).
Vegetables
(
fruiting,
bulb,
cucurbit),
lettuce
(
leaf,
head),
grapes
(
including
raisins),
potatoes,
hops,
grain,
brassica
(
leafy
greens),
leaves
of
root
and
tuber
vegetables,
and
taro
roots
as
the
target
crops
were
also
considered
for
this
analysis.
a.
Chronic.
Results
of
the
chronic
dietary
exposure
assessment
for
dimethomorph
(
BAS
550
F)
are
listed
in
Table
1.
The
estimated
chronic
dietary
exposure
for
all
current
and
pending
commodities
ranged
from
7.5%
to
15.2%
of
the
%
cPAD
(
0.1
mg/
kg
bwt/
day)
for
all
subpopulations.

TABLE
1.
 
CHRONIC
DIETARY
EXPOSURE
ASSESSMENT
FOR
DIMETHOMORPH
(
BAS
550
F)

Population
Exposure
Estimate
(
mg/
kg
bwt/
day)
%
cRfD
%
cPAD
Birth
to
1
 
year
0.007972
7.97
7.97
1
 
2
years
0.01513
15.13
15.13
3
 
5
years
0.01331
13.31
13.31
1
 
6
years
0.01512
15.12
15.12
6
 
12
years
0.007794
7.79
7.79
Teens
13
 
19
years
0.007482
7.48
7.48
Females
13
 
49
years
0.007771
7.77
7.77
Males
20
 
49
years
0.006853
6.85
6.85
Adults
50+
years
0.007548
7.55
7.55
b.
Acute.
Exposure
estimates
for
the
dimethomorph
acute
dietary
assessment
ranged
from
0.064
to
0.174
mg/
kg
bwt/
day
for
all
subpopulations
(
Table
2).
The
%
aRfd
and
%
aPAD
were
not
applicable
for
the
acute
dietary
assessment
since
toxicology
studies
have
shown
that
dimethomorph
poses
no
acute
dietary
risk.

TABLE
2.
 
ACUTE
DIETARY
EXPOSURE
ASSESSMENT
FOR
DIMETHOMORPH
(
BAS
550
F)

Population
Exposure
Estimate
(
mg/
kg
bwt/
day)
%
aRfD
%
aPAD
Birth
to
1
 
year
0.1736
NA
NA
1
 
2
years
0.1742
NA
NA
3
 
5
years
0.1584
NA
NA
1
 
6
years
0.1654
NA
NA
6
 
12
years
0.09621
NA
NA
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161
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Wednesday,
August
20,
2003
/
Notices
TABLE
2.
 
ACUTE
DIETARY
EXPOSURE
ASSESSMENT
FOR
DIMETHOMORPH
(
BAS
550
F)
 
Continued
Population
Exposure
Estimate
(
mg/
kg
bwt/
day)
%
aRfD
%
aPAD
Teens
13
 
19
years
0.07855
NA
NA
Females
13
 
49
years
0.07306
NA
NA
Males
20
 
49
years
0.06386
NA
NA
Adults
50
+
years
0.07058
NA
NA
Results
of
the
chronic
and
acute
dietary
exposure
analysis
demonstrate
a
reasonable
certainty
that
no
harm
to
the
general
U.
S.
population
or
any
subpopulation
would
results
from
the
use
of
dimethomorph
on
vegetables
(
fruiting,
bulb,
cucurbit),
lettuce
(
leaf,
head),
grapes
(
including
raisins),
potatoes,
hops,
grain,
brassica
(
leafy
greens),
leaves
of
root
and
tuber
vegetables,
and
taro
root.
ii.
Drinking
water.
EPA's
Pesticide
Root
Zone
Model/
Exposed
Analysis
Modeling
System
(
PRZM/
EXAMS)
and
Screening
Concentration
in
Groundwater
(
SCI­
GROW)
models
were
used
to
estimate
the
maximum
dimethomorph
concentrations
in
surface
water
and
ground
water,
respectively.
Results
for
the
chronic
drinking
water
assessment
are
listed
in
Table
3.

TABLE
3.
 
CHRONIC
DRINKING
WATER
ASSESSMENT
FOR
DIMETHOMORPH
DWLOC
chronic
Adult
males
20
 
49
Adult
females
13
 
49
Children
1
 
6
years
Children
birth
to
1
No
effect
level
9
9
9
9
Safety
factor
100
100
100
100
RfD=
0.09
0.09
0.09
0.09
cPAD
0.09
0.09
0.09
0.09
A)
Chronic
food
(
mg/
kg/
day)
0.006853
0.007771
0.01512
0.007972
B)
Residential
(
mg/
kg/
day)
0
0
0
0
water
cPAD­(
A+
B)
0.08314700
0.10222900
0.07488000
0.08202800
DWLOC
chronic
µ
g/
L
2910
3067
749
820
DEC's
PRZM/
EXAMS
(
EFED)
surface
water
(
µ
g/
L)
12.65
12.65
12.65
12.65
Sci­
Grow
(
EFED)
ground
water
0.26
0.26
0.26
0.26
2.
Aggregate
exposure
(
diet
+
water).
The
aggregate
exposure
of
dimethomorph
residues
for
food
and
drinking
water
is
summarized
in
Table
4
below.
Currently
dimethomorph
(
BAS
550
F)
is
not
considered
for
residential
use
and
therefore
residential
exposure
was
not
included
in
the
aggregate
exposure
assessment.

TABLE
4.
 
AGGREGATE
EXPOSURE
OF
DIMETHOMORPH
(
BAS
550
F)

Exposure
Infants
(
0
 
1
years)
Children
(
1
 
6
years)
Males
(
20
 
49
years)
Females
(
13
 
49
years)

FOOD
Acute
exposure
(
mg/
kg
bwt/
day)
0.1736
0.1654
0.06386
0.07306
Chronic
exposure
(
mg/
kg
bwt/
day)
0.007972
0.01512
0.006853
0.007771
%
aRfD
and
%
aPAD
NA
NA
NA
NA
%
cRfD
and
%
cPAD
7.97
15.12
6.85
7.77
WATER
Acute
exposure
(
mg/
kg/
bwt)
0.001265
0.000843
0.000361
0.000402
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Vol.
68,
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161
/
Wednesday,
August
20,
2003
/
Notices
TABLE
4.
 
AGGREGATE
EXPOSURE
OF
DIMETHOMORPH
(
BAS
550
F)
 
Continued
Exposure
Infants
(
0
 
1
years)
Children
(
1
 
6
years)
Males
(
20
 
49
years)
Females
(
13
 
49
years)

Chronic
exposure
(
mg/
kg
bwt/
day)
0.001265
0.000843
0.000361
0.000402
%
aRfD
and
%
aPAD
NA
NA
NA
NA
%
cRfD
and
%
cPAD
25.30
16.87
7.23
8.03
AGGREGATE
Acute
exposure
(
mg/
kg
bwt/
day)
0.174865
0.166243
0.064221
0.073462
Chronic
exposure
(
mg/
kg
bwt/
day)
0.009237
0.015963
0.007214
0.008173
%
aRfD
and
%
aPAD
NA
NA
NA
NA
%
cRfD
and
%
cPAD
33.27
31.99
14.08
15.80
These
results
indicate
the
aggregate
exposure
of
dimethomorph
(
BAS
550
F),
from
potential
residues
in
food
and
drinking
water,
will
not
exceed
EPA's
level
of
concern
(
100%
of
RfD).
Overall,
considering
a
``
worst­
case''
scenario,
we
can
conclude
with
reasonable
certainty
that
no
harm
will
occur
from
either
acute
or
chronic
aggregate
exposure
of
dimethomorph
residues
in
the
current
and
pending
commodities.
3.
Non­
dietary
exposure.
Currently,
there
are
no
registered
residential
uses
for
dimethomorph
in
the
United
States.
Thus,
an
assessment
of
non­
dietary
exposure
is
not
relevant
to
this
petition.

D.
Cumulative
Effects
There
is
no
information
to
indicate
that
any
toxic
effects
produced
by
dimethomorph
would
be
cumulative
with
those
of
any
other
chemical.
The
fungicidal
mode
of
action
of
dimethomorph
is
unique;
dimethomorph
inhibits
cell
wall
formation
only
in
Oomycete
fungi.
The
result
is
lysis
of
the
cell
wall
that
kills
growing
cells
and
inhibits
spore
formation
in
mature
hyphae.
This
unique
mode
of
action
and
limited
pest
spectrum
suggest
that
there
is
little
or
no
potential
for
cumulative
toxic
effects
in
mammals.
In
addition,
the
toxicity
studies
submitted
to
support
this
petition
do
not
indicate
that
dimethomorph
is
a
particularly
toxic
compound.
No
toxic
end­
points
of
potential
concern
were
identified.

E.
Safety
Determination
1.
U.
S.
population.
Based
on
the
acute
toxicity
data,
BASF
believes
that
dimethomorph
does
not
pose
any
acute
dietary
risks.
Therefore,
a
calculation
of
an
acute
RfD
is
not
needed.
The
cPAD
is
0.1
mg/
kg
bwt/
day,
based
on
a
NOAEL
of
approximately
10
mg/
kg
bwt/
day
(
200
ppm)
from
a
2
 
year
dietary
toxicity
study
in
rats
that
demonstrated
decreased
body
weight
and
liver
foci
in
females
at
750
ppm.
The
cPAD
is
calculated
using
an
uncertainty
factor
of
100.
The
theoretical
maximum
residue
concentration
(
TMRC)
for
all
commodities
covered
in
this
petition
is
estimated
at
0.003
mg/
kg
bwt/
day
for
the
general
population.
This
represents
a
dietary
exposure
to
the
general
population
of
the
United
States
that
is
3.0%
of
the
cPAD.
The
combined
TMRC
for
all
current
and
pending
dimethomorph
tolerances
in
potatoes,
tomatoes,
grapes,
hops,
cereal
grain
commodities,
lettuce
(
head
and
leaf),
endive
(
escarole),
radichio,
cucurbit
vegetables
(
crop
group
9),
bulb
vegetables
(
crop
group
3),
and
fruiting
vegetables
(
except
cucurbits)
(
crop
group
8)
will
utilize
less
than
10%
of
the
cPAD
for
the
general
U.
S.
population.
Since
EPA
generally
has
no
concern
for
exposures
below
100
percent
of
the
cPAD,
EPA
should
conclude
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
dimethomorph
residues
in
or
on
commodities
of
the
cited
crops.
2.
Infants
and
children.
The
TMRC
for
all
commodities
covered
in
this
petition
is
minimal.
The
consumption
of
residues
of
dimethomorph
on
commodities
associated
with
this
request
will
use
approximately
7.0%
of
the
cPAD
for
children
ages
1
 
6.
Moreover,
the
combined
TMRC
values
for
all
current
and
pending
dimethomorph
tolerances
will
utilize
less
than
10%
of
the
cPAD
for
each
of
the
subgroups.
The
results
of
the
studies
submitted
to
support
this
package
provide
no
evidence
that
dimethomorph
caused
reproductive,
developmental
or
fetotoxic
effects.
No
such
effects
were
noted
at
dose
levels
that
were
not
maternally
toxic.
The
NOAELs
observed
in
the
developmental
and
reproductive
studies
were
6
to
65
times
higher
than
the
NOAEL
used
to
establish
the
cPAD.
There
is
no
evidence
to
indicate
that
children
or
infants
would
be
more
sensitive
than
adults
to
toxic
effects
caused
by
exposure
to
dimethomorph.
Therefore,
the
registrant
believes
that
the
results
of
the
toxicology
and
metabolism
studies
support
both
the
safety
of
dimethomorph
to
humans
based
on
the
intended
use
as
a
fungicide
on
domestically
produced
fruiting
vegetables
(
except
cucurbits)
(
crop
group
8)
and
the
granting
of
the
requested
tolerances.

F.
International
Tolerances.

There
are
no
Canadian,
Mexican,
or
Codex
maximum
residue
levels
established
for
dimethomorph
for
the
commodities
associated
with
this
request;
consequently,
a
discussion
of
international
harmonization
is
not
relevant.
[
FR
Doc.
03
 
20899
Filed
8
 
19
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0222;
FRL
 
7316
 
3]

Issuance
of
Experimental
Use
Permits
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMMARY:
EPA
has
granted
experimental
use
permits
(
EUP)
to
the
following
pesticide
applicants.
An
EUP
permits
use
of
a
pesticide
for
experimental
or
research
purposes
only
in
accordance
with
the
limitations
in
the
permit.

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