55826
Federal
Register
/
Vol.
68,
No.
188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
nor
an
environmental
impact
statement
is
required.
This
rule
does
not
meet
the
definition
of
``
rule''
in
5
U.
S.
C.
804(
3)(
A)
because
it
is
a
rule
of
``
particular
applicability.''
Therefore,
it
is
not
subject
to
the
congressional
review
requirements
in
5
U.
S.
C.
801
 
808.

List
of
Subjects
in
21
CFR
Part
558
Animal
drugs,
Animal
feeds.


Therefore,
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
and
under
authority
delegated
to
the
Commissioner
of
Food
and
Drugs
and
redelegated
to
the
Center
for
Veterinary
Medicine,
21
CFR
part
558
is
amended
as
follows:

PART
558
 
NEW
ANIMAL
DRUGS
FOR
USE
IN
ANIMAL
FEEDS

1.
The
authority
citation
for
21
CFR
part
558
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
360b,
371.

§
558.355
[
Amended]


2.
Section
558.355
Monensin
is
amended
in
paragraph
(
f)(
1)(
xiv)(
b)
after
``
046573''
by
adding
``
and
053389''.

Dated:
September
11,
2003.
Linda
Tollefson,
Deputy
Director,
Center
for
Veterinary
Medicine.
[
FR
Doc.
03
 
24436
Filed
9
 
26
 
03;
8:
45
am]

BILLING
CODE
4160
 
01
 
S
DEPARTMENT
OF
HOMELAND
SECURITY
Coast
Guard
33
CFR
Parts
26,
161,
164,
and
165
[
USCG
 
2003
 
14757]

RIN
1625
 
AA67
Automatic
Identification
System;
Vessel
Carriage
Requirement
AGENCY:
Coast
Guard,
DHS.
ACTION:
Policy
statement.

SUMMARY:
The
Coast
Guard
is
announcing
its
policy
and
intent
to
establish
one
uniform
compliance
date
for
U.
S.
domestic
vessels
subject
to
Automatic
Identification
System
carriage
regulations
while
transiting
a
Vessel
Traffic
Service
(
VTS)
area.
On
July
1,
2003,
the
Coast
Guard
published
a
temporary
interim
rule
that
established
3
different
compliance
dates,
depending
on
particular
VTS
areas.
This
policy
statement
aligns
these
dates
with
the
deadline
date
of
the
Maritime
Transportation
Security
Act
of
2002.
DATES:
This
policy
is
effective
on
September
29,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
If
you
have
questions
on
this
Policy
Statement,
contact
Mr.
Jorge
Arroyo,
U.
S.
Coast
Guard
Office
of
Vessel
Traffic
Management
(
G
 
MWV),
by
telephone
202
 
267
 
6277,
toll­
free
telephone
1
 
800
 
842
 
8740
ext.
7
 
6277,
or
electronic
mail
JArroyo@
comdt.
uscg.
mil.

SUPPLEMENTARY
INFORMATION:

Background
On
July
1,
2003,
we
published
a
temporary
interim
rule
with
request
for
comments
and
notice
of
public
meeting
titled
``
Automatic
Identification
System;
Vessel
Carriage
Requirement''
in
the
Federal
Register
(
68
FR
39353).
This
temporary
interim
rule
was
one
of
a
series
of
temporary
interim
rules
on
maritime
security
published
in
the
July
1,
2003,
issue
of
the
Federal
Register.
On
July
16,
2003,
we
published
a
document
correcting
typographical
errors
and
omissions
in
that
rule
(
68
FR
41913).
The
temporary
interim
rule
established
an
Automatic
Identification
System
(
AIS)
compliance
date
that
varies
depending
upon
VTS
area.
They
are
as
follows:
(
1)
For
VTS
St.
Marys
River,
not
later
than
December
31,
2003;
(
2)
For
VTS
Berwick
Bay,
VMRS
Los
Angeles/
Long
Beach,
VTS
Lower
Mississippi
River,
VTS
Port
Arthur
and
VTS
Prince
William
Sound,
not
later
than
July
1,
2004;
and
(
3)
For
VTS
Houston­
Galveston,
VTS
New
York,
VTS
Puget
Sound,
and
VTS
San
Francisco,
not
later
than
December
31,
2004.
These
deadline
dates
were
established
to
coincide
with
anticipated
AIScapability
at
each
of
these
respective
ports
via
our
Ports
and
Waterways
Safety
System
(
PAWSS)
upgrades.
PAWSS
is
an
effort
to
establish
a
national
transportation
system
that
collects,
processes,
and
disseminates
information
on
the
marine
operating
environment
and
maritime
vessel
traffic
in
major
U.
S.
ports
and
waterways.
Work
continues
on
schedule
in
our
PAWSS
process;
however,
we
recognize
that
having
differing
deadline
dates
has
caused
unwarranted
confusion
and
may
place
certain
vessels
at
a
disadvantage
of
reaping
market
benefits.
Therefore,
the
Coast
Guard
will
amend
its
temporary
interim
rule,
by
a
forthcoming
final
rule,
that
will
adopt
December
31,
2004,
as
the
compliance
date
for
all
VTS
users,
not
on
international
voyage,
that
are
subject
to
the
provisions
of
33
CFR
164.46(
b).
Policy
Statement
Until
the
Coast
Guard
publishes
its
final
rule
regarding
AIS
carriage
requirements,
the
following
policy
applies:
The
Coast
Guard
will
not
enforce
the
deadline
dates
as
stated
in
33
CFR
164.46(
c)(
1)
through
(
4).

How
Long
Will
This
Policy
Remain
in
Effect?
This
policy
will
remain
in
effect
until
publication
of
the
final
rule
regarding
AIS
carriage
[
USCG
2003
 
14757],
that
we
anticipate
publishing
prior
to
October
25,
2003.
In
the
final
rule
we
intend
to
adopt
December
31,
2004,
as
the
deadline
date
for
domestic
AIS
carriage
for
those
vessels
denoted
in
33
CFR
164.46(
b).

Dated:
September,
22
2003.
T.
H.
Gilmour,
Rear
Admiral,
Coast
Guard,
Assistant
Commandant
for
Marine
Safety,
Security
and
Environmental
Protection.
[
FR
Doc.
03
 
24571
Filed
9
 
26
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0303;
FRL
 
7327
 
3]

Dimethomorph;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
dimethomorph
in
or
on
brassica,
leafy
greens,
subgroup
5B;
taro,
corm;
taro,
leaves;
and
vegetable,
fruiting,
group
8.
EPA
is
also
deleting
certain
dimethomorph
tolerances
that
are
no
longer
needed
as
a
result
of
this
action.
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
29,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0303,
must
be
received
on
or
before
November
28,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
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Federal
Register
/
Vol.
68,
No.
188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
(
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
an
are
agricultural
producer,
food
manufacturer,
and
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
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
 
2003
 
0303.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
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.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
20,
2003
(
68
FR
50138)
(
FRL
 
7321
 
7),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP
2E6483
and
3E6558)
by
IR­
4,
681
US
Highway
#
1
South,
New
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
BASF
Corporation,
the
registrant.
The
petitions
requested
that
40
CFR
180.493
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide,
dimethomorph,(
E,
Z)
4­[
3­(
4­
chlorophenyl)­
3­(
3,4­
dimethoxyphenyl)­
1­
oxo­
2­
propenyl]
morpholine
in
or
on
the
following
commodities:
Brassica,
leafy
greens,
subgroup
5B
at
20.0
part
per
million
(
ppm);
taro,
corm
at
0.5
ppm;
taro,
leaves
at
6.0
ppm;
and
vegetable,
fruiting,
group
8
at
2.0
ppm.
The
tolerance
petition
for
vegetable,
fruiting,
group
8
was
subsequently
amended
to
propose
the
tolerance
at
1.5
ppm.
EPA
is
also
deleting
tolerances
for
tomato,
fruit
at
0.5
ppm,
and
tomato,
paste
at
1.0
ppm
established
under
section
180.493
(
a).
These
commodities
will
be
covered
by
the
tolerance
for
vegetable,
fruiting,
group
8
at
1.5
ppm.
There
were
no
comments
received
on
these
petitions.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
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
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
rasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
tolerances
for
residues
of
dimethomorph
on
brassica,
leafy
greens,
subgroup
5B
at
20.0
ppm;
taro,
corm
at
0.5
ppm;
taro,
leaves
at
6.0
ppm;
and
vegetable,
fruiting,
group
8
at
1.5
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
follow.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
dimethomorph
are
discussed
in
the
Federal
Register
of
September
27,
2002
(
67
FR
60916)
(
FRL
 
7199
 
2).

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
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/
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68,
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188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factors
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
dimethomorph
used
for
human
risk
assessment
is
shown
is
shown
in
Table
1
of
this
unit:

TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
DIMETHOMORPH
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
females
13­
50
years
of
age
Not
applicable
Not
applicable
No
endpoint
attributable
to
a
single
dose
was
identified.

Acute
dietary
general
population
including
infants
and
children
Not
applicable
Not
applicable
No
endpoint
attributable
to
a
single
dose
was
identified
Chronic
dietary
all
populations
NOAEL=
11
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.1
mg/
kg/
day
Special
FQPA
SF
=
1
cPAD
=
chronic
RfD/
Special
FQPA
SF
=
0.1
mg/
kg/
day
Carcinogenicity
study
in
the
rat
LOAEL
=
46.3
mg/
kg/
day
based
on
decreased
body
weight
and
statistically
significant
increases
in
liver
lesions
in
female
rats
Short­
term
dermal
(
1
to
7
days)
Oral
study
NOAEL=
60
mg/
kg/
day
(
dermal
absorption
factor
=
5
%)
LOC
for
MOE
=
100
Developmental
toxicity
study
in
the
rat
LOAEL
=
160
mg/
kg/
day
based
on
decreased
body
weight,
decreased
body
weight
gain,
and
decreased
food
consumption
Intermediate­
term
dermal
(
1
week
to
several
months)
Oral
study
NOAEL=
15
mg/
kg/
day
(
dermal
absorption
factor
=
5
%
LOC
for
MOE
=
100
Subchronic
feeding
study
in
dogs
LOAEL
=
43
mg/
kg/
day
based
on
decreased
absolute
and
relative
prostate
weight
and
possible
threshold
liver
effects
Long­
term
dermal
(
several
months
to
lifetime)
Not
applicable
Not
applicable
The
current
use
pattern
does
not
indicate
a
concern
for
long­
term
exposure
risk
Short­
term
inhalation
(
1
to
7
days)
Oral
study
NOAEL=
60
mg/
kg/
day
(
inhalation
absorption
factor
=
100
%)
LOC
for
MOE
=
100
Developmental
toxicity
study
in
the
rat
LOAEL
=
160
mg/
kg/
day
based
on
decreased
body
weight,
decreased
body
weight
gain,
and
decreased
food
consumption
Intermediate­
term
nhalation
(
1
week
to
several
months)
Oral
study
NOAEL=
15
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
Subchronic
feeding
study
in
dogs
LOAEL
=
43
mg/
kg/
day
based
on
decreased
absolute
and
relative
prostate
weight
and
possible
threshold
liver
effects
Long­
term
inhalation
(
several
months
to
lifetime)
Not
applicable
Not
applicable
The
current
use
pattern
does
not
indicate
a
concern
for
long­
term
exposure
risk
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Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
DIMETHOMORPH
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
oral,
dermal,
inhalation
Not
applicable
Not
applicable
This
chemical
is
classified
as
``
not
likely
to
be
a
human
carcinogen
C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.493)
for
the
residues
of
dimethomorph,
in
or
on
[
grape;
grape,
raisin;
hop,
dried
cones;
lettuce,
head;
lettuce,
leaf;
potato,
wet
peel;
tomato;
tomato,
paste;
vegetable,
bulb,
group
3;
and
vegetable,
cucurbit,
group
9.
Time­
limited
tolerances
are
also
established
for
residues
of
dimethomorph
in
connection
with
use
of
the
pesticide
under
emergency
exemptions
pursuant
to
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
for
cantaloupe,
cucumber,
squash,
and
watermelon
at
1.0
ppm
set
to
expire
on
December
31,
2003.
Additionally,
time­
limited
tolerances
are
established
for
inadvertent
or
indirect
residues
of
dimethomorph
in
or
on
the
following
raw
agricultural
commodities
when
present
therein
as
a
result
of
the
application
of
dimethomorph
to
growing
crops:
grain,
cereal
group,
fodder;
grain,
cereal
group,
forage;
grain,
cereal
group,
grain;
grain,
cereal
group,
hay;
and
grain,
cereal
group,
straw
at
0.15
ppm,
set
to
expire
on
May
12,
2004.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
dimethomorph
in
food
as
follows:
i.
Acute
exposure.
A
quantitative
acute
dietary
exposure
and
risk
assessment
was
not
conducted
for
dimethomorph
since
an
acute
oral
endpoint
attributed
to
a
single­
dose
exposure
could
not
be
identified
in
any
of
the
toxicology
studies,
including
developmental
and
maternal
toxicity
in
the
developmental
toxicity
studies.
No
acute
risk
is
expected
from
exposure
to
dimethomorph.
ii.
Chronic
exposure.
In
conducting
this
acute
dietary
risk
assessment
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMTM/
FCID)
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(
USDA)
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
was
made
for
the
chronic
exposure
assessment:
The
chronic
dietary
risk
assessment
for
dimethomorph
assumed
tolerance
level
residues
and
100%
crop
treated
(
Tier
1)
for
all
registered
and
proposed
crops.
iii.
Cancer.
EPA
has
classified
dimethomorph
as
a
``
not
likely''
human
carcinogen.
Therefore,
a
quantitative
cancer
dietary
exposure
and
risk
assessment
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
dimethomorph
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
dimethomorph.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
Screening
Concentrations
in
Ground
Water
(
SCI­
GROW),
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
GENEEC
(
a
Tier
1
model)
before
using
PRZM/
EXAMS
(
a
Tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
The
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
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
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
ince
DWLOCs
address
total
aggregate
exposure
to
dimethomorph
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
E.
Based
on
the
GENEEC
and
SCI­
GROW
models
the
EECs
of
dimethomorph
for
acute
exposures
are
estimated
to
be
79.8
parts
per
billion
(
ppb)
for
surface
water
and
0.30
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
28.5
ppb
for
surface
water
and
0.30
ppb
for
ground
water.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
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
screen
for
sorting
out
pesticides
for
which
it
is
unlikely
that
drinking
water
concentrations
would
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
EECs
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
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29,
2003
/
Rules
and
Regulations
dimethomorph
they
are
further
discussed
in
the
aggregate
risk
Unit
E.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Dimethomorph
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
dimethomorph
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
dimethomorph
and
any
other
substances
and
dimethomorph
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
dimethomorph
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
developmental
and
reproductive
toxicity
data
did
not
indicate
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
dimethomorph
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X.
The
FQPA
SF
is
removed
because:
Acceptable
developmental
toxicity
studies
in
the
rat
and
the
rabbit
are
available,
as
is
an
acceptable
2
 
generation
reproduction
study
in
the
rat
and
there
is
no
indication
of
qualitative
or
quantitative
increased
susceptibility
of
rats
and
rabbits
to
in
utero
or
postnatal
exposure.
A
developmental
neurotoxicity
study
is
not
required
for
dimethomorph.
The
dietary
(
food
and
water)
exposure
assessments
are
not
expected
to
underestimate
the
potential
exposures
for
infants
and
children
from
the
use
of
dimethomorph.
Residential
exposure
to
dimethomorph
is
not
expected
since
there
are
no
registered
residential
uses
for
the
pesticide.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
dimethomorph
from
food
will
utilize
7%
of
the
cPAD
for
the
U.
S.
population,
0.8%
of
the
cPAD
for
all
infants
<
1
year
old,
16%
of
the
cPAD
for
children
1
 
2
years
old
(
the
most
highly
exposed
population
subgroup),
and
6%
of
the
cPAD
for
females
13­
49
years
old.
Based
on
the
lack
of
residential
uses,
chronic
residential
exposure
to
residues
of
dimethomorph
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
dimethomorph
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
2
of
this
unit:

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Rules
and
Regulations
TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
DIMETHOMORPH
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.10
7
28.50
0.30
3,253
All
infants
(<
1
year
old)
0.10
0.8
28.50
0.30
960
Children
(
1­
2
years
old)
0.10
16
28.50
0.30
842
Females
(
13­
49
years
old)
0.10
6
28.50
0.30
2,812
2.
Short­
and
intermediate­
term
risk.
Short­
and
intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Dimethomorph
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
3.
Aggregate
cancer
risk
for
U.
S.
population.
Dimethomorph
is
no
carcinogenic.
This
classification
was
based
upon
lack
of
evidence
of
carcinogenicity
in
rats
and
mice.
The
Agency
concludes
that
the
pesticidal
uses
of
dimethomorph
are
not
likely
to
pose
a
cancer
risk
to
humans.
4.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
dimethomorph
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
A
reliable
method
for
the
determination
of
dimethomorph
residues
in
fruiting
vegetables
crop
group
8,
leafy
brassica
greens
subgroup
5B,
taro
leaves
and
roots
exists;
this
method
is
the
FDA
Multi­
Residue
Method,
Protocol
D,
as
published
in
the
Pesticide
Analytical
Manual
I.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
email
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
established
or
proposed
Codex,
Canadian
or
Mexican
maximum
residue
limits
or
tolerances
for
dimethomorph
in
or
on
taro,
corm;
taro,
leaves;
brassica,
leafy
greens,
subgroup
5B;
or
vegetable,
fruiting,
group
8.
V.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
dimethomorph,
in
or
on
brassica,
leafy
greens,
subgroup
5B;
taro,
corm;
taro,
leaves;
and
vegetable,
fruiting,
group
8.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
o
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0303
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
28,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
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68,
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188
/
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September
29,
2003
/
Rules
and
Regulations
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0303,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
tolerances
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerances
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

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Federal
Register
/
Vol.
68,
No.
188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
Dated:
September
22,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.493
is
amended
by
removing
the
entries
``
tomato''
and
``
tomato,
paste''
and
by
alphabetically
adding
the
following
commodities
to
the
table
in
paragraph
(
a)
to
read
follows:

§
180.493
Dimethomorph;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
Brassica,
leafy
greens,
subgroup
5B
...............................
20.0
*
*
*
*
*

Taro,
corm
................................
0.5
Taro,
leaves
..............................
6.0
*
*
*
*
*

Vegetable,
fruiting,
group
8
......
1.5
*
*
*
*
*
[
FR
Doc.
03
 
24564
Filed
9
 
26
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0058;
FRL
 
7327
 
9]

Glufosinate
Ammonium;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
glufosinate
ammonium
and
its
metabolites
in
or
on
certain
raw
agricultural
commodities.
Aventis
CropScience
USA,
now
Bayer
CropScience,
and
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
29,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0058,
must
be
received
on
or
before
November
28,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Joanne
I.
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
703
 
305
 
6224;
e­
mail
address:
miller.
joanne@
epamail.
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
categories
and
entities
may
include,
but
are
not
limited
to:

 
Crop
production
(
NAICS
111)

 
Animal
production
(
NAICS
112)

 
Food
manufacturing
(
NAICS
311)

 
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
 
2003
 
0058.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html/,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
May
19,
2000
(
65
FR
31904)
(
FRL
 
6558
 
2),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
0F6140)
by
Aventis
CropScience
USA,
now
Bayer
CropScience,
PO
Box
12014,
2
T.
W.
Alexander
Drive,
Research
Triangle
Park,
NC
27709.
That
notice
included
a
summary
of
the
petition
prepared
by
Bayer
CropScience,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
In
the
Federal
Register
of
July
24,
2002
(
67
FR
48465)
(
FRL
 
7184
 
6),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
OF6210)
by
Aventis
CropScience
USA,
now
Bayer
CropScience,
PO
Box
12014,
2
T.
W.
Alexander
Drive,
Research
Triangle
Park,
NC
27709.
That
notice
included
a
summary
of
the
petition
prepared
by
Bayer
CropScience,
the
registrant.
Comments
on
the
petition
were
filed
by
Neil
J.
Carman,
Ph.
D.
of
the
Sierra
Club
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