43465
Federal
Register
/
Vol.
68,
No.
141
/
Wednesday,
July
23,
2003
/
Rules
and
Regulations
Implementation
Plan
revision
have
been
approved.
(
4)
The
revised
commitment
to
perform
a
mid­
course
review
and
submit
the
results
by
December
31,
2004
included
in
the
April
8,
2003
SIP
revision
is
approved.
[
FR
Doc.
03
 
18853
Filed
7
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0242;
FRL
 
7317
 
5]

Thiophanate
Methyl;
Pesticide
Tolerance
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
residues
of
thiophanate
methyl
and
its
metabolite
methyl
2­
benzimidazoyl
carbamate
(
MBC)
in
or
on
fruiting
vegetables.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
the
pesticide
on
fruiting
vegetables.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
thiophanate
methyl
in
this
food
commodity.
The
tolerance
will
expire
and
is
revoked
on
December
31,
2005.
DATES:
This
regulation
is
effective
July
23,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0242,
must
be
received
on
or
before
September
22,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Andrea
Conrath,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9356;
e­
mail
address:
conrath.
andrea@
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:
 
Crop
producers
(
NAICS
111)
 
Animal
producers
(
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
 
0242.
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
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408
(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
is
establishing
a
tolerance
for
residues
of
the
fungicide
thiophanate
methyl
and
its
metabolite
methyl
2­
benzimidazoyl
carbamate,
in
or
on
vegetables,
fruiting,
group
8
at
0.5
parts
per
million
(
ppm).
This
tolerance
will
expire
and
is
revoked
on
December
31,
2005.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerance
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
of
the
FFDCA
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
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
reasonable
certainty
that
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14:
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43466
Federal
Register
/
Vol.
68,
No.
141
/
Wednesday,
July
23,
2003
/
Rules
and
Regulations
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Section
18
of
the
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
Agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.

III.
Emergency
Exemptions
for
Thiophanate
Methyl
on
Fruiting
Vegetables
and
FFDCA
Tolerances
Benomyl
has
historically
been
used
to
control
the
disease
caused
by
sclerotinia
sclerotiorum,
more
commonly
known
as
white
mold,
timber
rot,
or
sclerotinia
stem
rot,
in
fruiting
vegetables,
including
tomatoes.
The
recent
cancellation
of
benomyl
has
left
fruiting
vegetable
producers
in
Florida,
and
tomato
producers
in
New
Jersey
and
Virginia
without
sufficient
means
to
control
this
disease,
and
the
applicants
claim
that
there
are
no
other
registered
fungicides
or
alternative
control
practices
which
are
effective
to
control
this
disease.
Thiophanate
methyl
is
related
to
benomyl,
and
degrades
to
the
same
active
compound
as
benomyl.
Field
trial
data
also
shows
thiophanate
methyl
to
be
significantly
effective
at
controlling
white
mold.
It
is
expected
that
a
similar
level
of
control
would
be
achieved
with
thiophanate
methyl
as
that
achieved
in
the
past
with
benomyl.
Significant
economic
losses
are
expected
without
the
requested
use
of
thiophanate
methyl.
EPA
has
authorized
under
FIFRA
section
18
the
use
of
thiophanate
methyl
on
fruiting
vegetables
in
Florida,
and
tomatoes
only
in
New
Jersey
and
Virginia,
for
control
of
white
mold,
also
known
as
timber
rot,
or
sclerotinia
stem
rot
(
sclerotinia
sclerotiorum).
After
having
reviewed
the
submissions,
EPA
concurs
that
emergency
conditions
exist
for
these
States.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
thiophanate
methyl
in
or
on
fruiting
vegetables.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
tolerance
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
FIFRA
section
18.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non­
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
issuing
this
tolerance
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6)
of
the
FFDCA.
Although
this
tolerance
will
expire
and
is
revoked
on
December
31,
2005,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
not
in
excess
of
the
amounts
specified
in
the
tolerance
remaining
in
or
on
fruiting
vegetables
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA,
and
the
residues
do
not
exceed
a
level
that
was
authorized
by
this
tolerance
at
the
time
of
that
application.
EPA
will
take
action
to
revoke
this
tolerance
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
this
pesticide
indicate
that
the
residues
are
not
safe.
Because
this
tolerance
is
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
thiophanate
methyl
meets
EPA's
registration
requirements
for
use
on
fruiting
vegetables
or
whether
a
permanent
tolerance
for
this
use
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
this
tolerance
serves
as
a
basis
for
registration
of
thiophanate
methyl
by
a
State
for
special
local
needs
under
FIFRA
section
24(
c).
Nor
does
this
tolerance
serve
as
the
basis
for
any
States
other
than
Florida,
New
Jersey,
or
Virginia
to
use
this
pesticide
on
this
crop
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
FIFRA
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemption
for
thiophanate
methyl,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.

IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
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
November
26,
1997
(
62
FR
62961)
(
FRL
 
5754
 
7).
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
thiophanate
methyl
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
timelimited
tolerance
for
residues
of
thiophanate
methyl
in
or
on
fruiting
vegetables
at
0.5
ppm.
The
most
recent
estimated
aggregate
risks
resulting
from
the
use
of
thiophanate
methyl,
are
discussed
in
the
Federal
Register
ofAugust
28,
2002
(
67
FR
55137)
(
FRL
 
7192
 
1),
final
rule
establishing
tolerances
for
residues
of
thiophanate
methyl
in/
on
grapes,
pears,
potatoes,
canola,
and
pistachios.
In
that
prior
action,
risk
was
estimated
assuming
tolerance
level
residues
in
all
commodities
for
established
and
proposed
tolerances.
Available
residue
data
indicate
that
the
use
pattern
for
these
emergency
exemptions
will
not
result
in
residues
of
thiophanate
methyl
in
fruiting
vegetables
over
0.5
ppm.
Therefore,
a
tolerance
is
being
established
for
this
crop
group
at
this
level.
The
risk
assessment
related
to
incremental
addition
of
these
items
at
this
level
to
dietary
exposure
is
discussed
below.
Refer
also
to
the
August
28,
2002
Federal
Register
document
for
a
detailed
discussion
of
the
aggregate
risk
assessments
and
determination
of
safety.
EPA
relies
in
part
upon
that
risk
assessment
and
the
findings
made
in
the
Federal
Register
document
in
support
of
this
action.
Below
is
a
brief
summary
of
the
aggregate
risk
assessment.
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.
A
summary
of
the
toxicological
dose
and
endpoints
for
thiophanate
methyl
for
use
in
human
risk
assessment
is
discussed
in
the
final
rule
published
in
the
Federal
Register
of
August
28,
2002
(
67
FR
55137)
(
FRL
 
7192
 
1).
For
thiophanate
methyl,
the
Agency
recently
modified
the
tolerance
expression,
so
that
the
residues
to
be
regulated
in
plant
and
animal
commodities
for
purposes
of
tolerance
enforcement
will
consist
of
the
residues
of
thiophanate
methyl
and
its
metabolite
methyl
2­
benzimidazolyl
carbamate,
expressed
as
thiophanate
methyl.
Exposure
from
the
use
of
benomyl,
another
pesticide
which
degrades
under
environmental
conditions
to
MBC
was
not
included
in
this
assessment
because
the
only
basic
registrant
of
benomyl
requested
voluntary
cancellation
of
all
benomyl­
containing
products
in
April
2001.
Product
cancellations
were
effective
in
early
2001
with
sales
and
distribution
of
benomyl
containing
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23,
2003
/
Rules
and
Regulations
products
ending
by
December
31,
2001.
However,
the
Agency
conducted
a
dietary
assessment
using
United
States
Department
of
Agriculture
(
USDA)
Pesticide
Data
Program
(
PDP)
monitoring
data
for
benomyl,
measured
as
MBC
to
estimate
residues
of
thiophanate
methyl
because
MBC
is
a
common
metabolite
of
both
benomyl
and
thiophanate
methyl.
PDP
data
were
available
for
apples,
bananas,
beans,
cucurbits,
peaches
and
strawberries.
The
PDP
analytical
method
employs
a
hydrolysis
step
that
converts
any
benomyl
present
to
MBC.
MBC
is
then
quantitated
and
corrected
for
molecular
weight,
and
results
are
measured
as
the
sum
of
benomyl
and
MBC.
Therefore,
using
MBC
data
to
estimate
thiophanate
methyl
residues
may
be
a
conservative
approach
in
that
it
may
overestimate
thiophanate
methyl
residues.
Monitoring
data
on
benomyl
from
the
PDP
were
used
to
estimate
dietary
exposure
to
MBC,
for
apples,
apple
juice,
bananas,
succulent
beans,
cantaloupes,
cucumbers,
peaches,
strawberries,
citrus,
and
fruiting
vegetables.
EPA
assessed
risk
scenarios
for
thiophanate
methyl
under
acute,
chronic,
and
short­
term
and
intermediate­
term
exposures.
Risk
estimates
were
calculated
for
the
residues
of
toxicological
concern,
the
parent
compound
thiophanate
methyl,
and
its
metabolites
methyl
2­
benzimidazolyl
carbamate
plus
2­
amine­
1­
H­
benzimidazole
(
MBC+
2­
AB).
To
update
the
previous
risk
assessment,
thiophanate­
methyl
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
most
current
version
of
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMTM­
FCID),
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994
 
1996/
98.
The
1998
CSFII
survey
focused
on
children
from
birth
to
9
years
old
and
greatly
expanded
(
by
several
fold)
the
number
of
children
aged
birth
to
4
years.
Importantly,
the
supplemental
survey
was
designed
in
a
manner
such
that
the
results
from
the
1998
CSFII
survey
could
be
combined
with
the
1994
 
96
survey.
The
data
in
this
newer
CSFII
survey
(
termed
the
1994
 
1996/
98
CSFII)
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
nonconsecutive
survey
days
and
is
considered
to
be
a
more
appropriate
and
more
robust
data
set
than
the
1989
 
91
CSFII
survey,
which
was
used
in
the
previous
assessment.
The
most
current
version
of
DEEMTMFCID
was
used
for
all
dietary
risk
estimates
calculated,
and
existing
uses,
as
well
as
the
proposed
section
18
uses
(
blackberries,
tomatoes
and
fruiting
vegetables)
were
included.
When
calculating
risk
estimates
from
MBC+
2­
AB,
an
FQPA
safety
factor
of
10
was
applied
for
all
infant
and
children
population
subgroups.
Percent
of
crop
treated
information
was
also
incorporated
for
most
established
uses
and
for
all
of
the
section
18
uses.
The
acute
and
chronic
dietary
risk
estimates
for
thiophanate
methyl
were
<
100%
of
the
acute
and
chronic
Population
Adjusted
Doses
(
aPAD
and
cPAD)
at
the
99.9th
exposure
percentile
for
the
general
U.
S.
population
and
all
population
subgroups.
The
acute
and
chronic
dietary
risk
estimates
for
MBC
+
2­
AB
were
also
<
100%
of
the
aPAD
and
cPAD
at
the
99.9th
exposure
percentile
for
the
general
U.
S.
population
and
all
population
subgroups.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
PADs,
because
the
PADs
represent
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
The
most
highly
exposed
subgroup
for
all
risk
estimates
calculated
was
children
1
 
2
years.
Table
1
summarizes
the
percentages
of
aPADs
and
cPADs
for
all
scenarios
for
the
overall
U.
S.
population
and
for
the
most
highly
exposed
population
subgroup
(
children
1
 
2
years).

TABLE
1.
 
ACUTE
AND
CHRONIC
DIETARY
RISK
ESTIMATES
FOR
THIOPHANATE
METHYL
EXISTING
AND
PROPOSED
USES
Population
Subgroup
aPAD
Utilized
cPAD
Utilized
TM
MBC
+
2­
AB
TM
MBC
+
2­
AB
U.
S.
population
6%
2%
<
1%
<
1%

Children
(
1
 
2
years)
22%
58%
2%
10%

The
acute
drinking
water
assessment,
based
on
simultaneous
dietary
exposure
to
both
MBC
and
thiophanate
methyl
(
which
was
converted
to
MBC
equivalents)
resulted
in
Drinking
Water
Levels
of
Comparison
(
DWLOCs)
for
the
overall
U.
S.
population
of
5,833
parts
per
billion
(
ppb),
and
for
children
(
1
 
2
years)
of
72
ppb
(
the
population
subgroup
with
the
lowest
DWLOC).
All
acute
DWLOCs
were
well
above
the
acute
Estimated
Environmental
Concentrations
(
EECs)
for
ground
water
and
surface
water,
at
3
and
44
ppb,
respectively
The
chronic
drinking
water
assessment,
based
on
simultaneous
dietary
exposure
to
both
MBC
and
thiophanate
methyl
(
which
was
converted
to
MBC
equivalents)
resulted
in
chronic
DWLOCs
for
the
overall
U.
S.
population
of
870
ppb,
and
for
children
(
1
 
2
years)
of
22
ppb
(
the
population
subgroup
with
the
lowest
DWLOC).
All
chronic
DWLOCs
were
well
above
the
chronic
EEC
for
ground
water
of
3
ppb.
The
chronic
DWLOCs
were
also
above
the
chronic
EEC
for
surface
water
of
23
 
24
ppb,
except
for
that
of
the
most
highly
exposed
subgroup,
children
(
1
 
2
years),
which
is
slightly
below
the
EEC
with
a
chronic
DWLOC
of
22
ppb.
However,
given
the
conservative
nature
of
the
screening­
level
approach
to
estimated
drinking
water
risks,
and
the
equivalent
levels
of
the
chronic
DWLOC
and
EEC
(
22
 
23
 
24
ppb),
the
Agency
does
not
believe
this
represents
a
significant
risk
or
concern
for
chronic
aggregate
exposures.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Thiophanate
methyl
and
MBC
are
currently
registered
for
uses
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
thiophanate
methyl
and
MBC.
All
residential
exposures
are
considered
to
be
short­
term.
The
Margins
of
Exposure
(
MOEs)
(
converted
to
MBC
equivalents)
for
aggregate
shortterm
exposure
to
thiophanate
methyl
are
as
follows:
Oral
exposure
of
children
(
1
 
6
years)
is
670;
dermal
exposure
of
children
(
1
 
6
years)
is
1,000;
and
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23,
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/
Rules
and
Regulations
dermal
exposure
of
females
(
13
 
50
years)
is
1,315.
Prior
to
the
application
rate
change
agreed
to
by
the
registrants
in
connection
with
the
Agency's
reregistration
process
evaluation
of
thiophanate
methyl,
MOEs
for
aggregate
exposure
to
MBC
from
the
use
of
MBC
as
an
in­
can
paint
preservative
were
670
for
dermal
exposure
and
770
for
exposure
via
inhalation.
As
a
result
of
negotiated
mitigation
measures
related
to
the
reregistration
review
of
this
chemical,
the
registrant
has
now
lowered
the
application
rate
for
the
incan
paint
uses
to
the
extent
that
the
MOEs
are
now
acceptable
(>
1,000).
The
MOEs
(
converted
to
MBC
equivalents)
for
the
total
thiophanate
methyl
and
MBC
aggregate
exposure
are
as
follows:
630
for
oral
and
dermal
exposure
of
children
(
1
 
6
years);
770
for
exposure
via
inhalation
for
females
(
13
 
50
years);
and
620
for
oral
and
dermal
exposure
for
females
(
13
 
50
years).
The
aggregate
short­
term
exposure
to
MBC
and
thiophanate
methyl
resulting
from
food,
water
and
residential
use
exceeds
the
Agency's
level
of
concern
for
children
(
infants,
and
1
 
6
years),
and
females
13
 
50
years,
due
primarily
to
postapplication
exposures
on
turf.
Registrants
are
performing
a
hand
press
study
and
have
submitted
a
5
 
day
inhalation
study
to
help
refine
this
assessment.
Based
on
these
mitigation
measures,
and
the
conservative
method
of
exposure
estimation,
the
risks
do
not
exceed
the
Agency's
level
of
concern.
Aggregate
cancer
risk
for
U.
S.
population.
The
total
thiophanate
methyl
and
MBC+
2­
AB
dietary
cancer
risk
is
1.1
x
10­
6
for
existing
and
proposed
new
uses
(
incorporating
the
refinements
and
amortizations
as
previously
described).
The
cancer
risk
from
non­
occupational
residential
exposure
is
1.1
x
10­
6.
Therefore,
aggregate
cancer
risk
is
2.2
x
10­
6.
This
risk
estimate
includes
cancer
risk
from
both
thiophanate
methyl
and
MBC+
2­
AB
on
food
including
all
pending
uses
and
section
18
uses,
thiophanate
methyl
exposure
from
treating
ornamentals,
thiophanate
methyl
exposure
from
performing
post­
application
lawn
activities,
and
exposure
from
applying
paint
containing
MBC.
This
is
considered
to
be
a
high­
end
risk
scenario
since
it
is
not
expected
that
someone
would
treat
ornamentals,
perform
high
exposure
post­
application
activities,
and
apply
paint
containing
MBC
every
year
for
70
years.
Therefore,
this
estimate
is
considered
to
be
a
conservative
estimate.
Additionally,
the
cancer
risk
estimate
for
drinking
water
is
based
on
the
highest
EEC,
which
is
also
a
very
high­
end
risk
estimate
since
it
is
based
on
the
maximum
rate
being
applied
every
season
for
70
years.
The
risk
estimate
calculations
also
assumed
that
the
modeled
surface
water
EEC
is
equivalent
to
concentrations
in
finished
drinking
water.
Thus,
food
plus
water
plus
non­
occupational
residential
cancer
risk
is
2.2
x
10­
6
which
is
within
the
range
considered
as
negligible.
Therefore,
the
risks
do
not
exceed
the
Agency's
level
of
concern.
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
thiophanate
methyl
and
MBC+
2­
AB
residues.

V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
is
available
to
enforce
the
tolerance
expression.
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;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
The
Codex
Alimentarius
Commission
has
established
maximum
residue
limits
(
MRLs)
for
thiophanate
methyl
residues
in/
on
various
plant
and
animal
commodities.
Codex
MRLs
for
thiophanate
methyl
are
currently
expressed
as
MBC.
The
Codex
MRL
residue
definition
and
the
U.
S.
tolerance
definition,
previously
expressed
as
only
thiophanate
methyl,
have
been
incompatible
and
will
remain
incompatible
even
with
the
recent
revision
of
the
U.
S.
tolerance
definition,
since
the
revised
tolerance
definition
includes
both
thiophanate
methyl
and
MBC.
Additionally,
there
is
a
5.0
ppm
Codex
MRL
for
thiophanate
methyl
on
tomatoes.
The
0.5
ppm
tolerance
for
fruiting
vegetables,
including
tomatoes,
being
established
by
this
document
will
not
harmonize
with
Codex.

C.
Conditions
The
pesticide,
thiophanate
methyl
may
be
applied
using
ground
equipment,
at
a
rate
of
1
lb.
of
formulated
product
(
0.7
lb.
active
ingredient
(
a.
i.))
per
acre,
not
to
exceed
4
lbs.
(
2.8
lbs.
a.
i.)
per
acre
per
crop.
A
maximum
of
four
applications
per
crop
may
be
made
at
7
to
14
day
intervals,
and
a
2
 
day
pre­
harvest
interval
must
be
observed.
Applications
may
not
be
made
through
any
type
of
irrigation
system.
VI.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
thiophanate
methyl
and
its
metabolite,
MBC,
expressed
as
thiophanate
methyl,
in
or
on
vegetables,
fruiting,
group
8
at
0.5
ppm.

VII.
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
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
the
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
 
0242
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
September
22,
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
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68,
No.
141
/
Wednesday,
July
23,
2003
/
Rules
and
Regulations
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
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
VII.
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
the
docket
ID
number
OPP
 
2003
 
0242,
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:
opp­
docket@
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).

VIII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
timelimited
tolerance
under
section
408
of
the
FFDCA.
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
FIFRA
section
18
exemption
under
section
408
of
the
FFDCA,
such
as
the
tolerance
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.''
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Federal
Register
/
Vol.
68,
No.
141
/
Wednesday,
July
23,
2003
/
Rules
and
Regulations
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.

IX.
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.

Dated:
July
10,
2003.
Deborah
McCall,
Acting
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
180.371
is
amended
by
alphabetically
adding
the
following
commodity
to
the
table
in
paragraph
(
b)
to
read
as
follows:

§
180.371
Thiophanate
methyl;
tolerances
for
residues.

*
*
*
*
*
(
b)
*
*
*

Commodity
Parts
per
million
Expiration/
revocation
date
*
*
*
*
*
*
*
Vegetable,
fruiting,
group
8
.........................................................................................................................
0.5
12/
31/
05
*
*
*
*
*
[
FR
Doc.
03
 
18499
Filed
7
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
HOMELAND
SECURITY
Coast
Guard
46
CFR
Part
401
[
USCG
 
2002
 
12840]

RIN
1625
 
AA74
(
Formerly
2115
 
AG46)

Basic
Rates
and
Charges
on
Lake
Erie
and
the
Navigable
Waters
From
Southwest
Shoal
to
Port
Huron,
MI
AGENCY:
Coast
Guard,
DHS.
ACTION:
Temporary
final
rule;
change
of
effective
period.

SUMMARY:
The
Coast
Guard
is
extending
the
effective
period
for
the
temporary
final
rule
on
basic
rates
and
charges
on
Lake
Erie
and
the
navigable
waters
from
Southwest
Shoal
to
Port
Huron,
MI
(
District
Two,
Area
5),
to
December
24,
2003.
Extension
of
the
effective
period
ensures
that
the
pilotage
rates
in
District
Two,
Area
5,
remain
at
the
current
rate
while
the
Coast
Guard
completes
its
pending
ratemaking
project.
DATES:
Effective
July
18,
2003,
§
401.407(
b),
suspended
at
67
FR
47466,
July
19,
2002,
effective
July
19,
2002,
until
July
21,
2003,
will
continue
to
be
suspended
through
December
24,
2003;
and
§
401.407(
c),
temporarily
added
at
67
FR
47466,
July
19,
2002,
effective
July
19,
2002,
until
July
21,
2003,
will
continue
to
be
extended
through
December
24,
2003.
ADDRESSES:
The
Docket
Management
Facility
maintains
the
public
docket
for
this
rulemaking.
Comments
and
material
received
from
the
public,
as
well
as
documents
mentioned
in
this
preamble
as
being
available
in
the
docket,
will
become
part
of
this
docket
and
will
be
available
for
inspection
or
copying
at
room
PL
 
401
on
the
Plaza
level
of
the
Nassif
Building,
400
Seventh
Street,
SW.,
Washington,
DC,
between
9
a.
m.
and
5
p.
m.,
Monday
through
Friday,
except
Federal
holidays.
You
may
also
find
this
docket
on
the
Internet
at
http://
dms.
dot.
gov.

FOR
FURTHER
INFORMATION
CONTACT:
If
you
have
questions
on
this
rule,
call
Tom
Lawler,
Project
Manager,
Office
of
Great
Lakes
Pilotage,
Coast
Guard,
Commandant
(
G
 
MW
 
1),
at
202
 
267
 
1241.
If
you
have
questions
on
viewing
to
the
docket,
call
Dorothy
Beard,
Chief,
Dockets,
Department
of
Transportation,
at
202
 
366
 
5149.

SUPPLEMENTARY
INFORMATION:

Regulatory
History
On
July
19,
2002,
we
published
a
temporary
final
rule
entitled
``
Basic
Rates
and
Charges
on
Lake
Erie
and
the
Navigable
Waters
From
Southeast
Shoal
to
Port
Huron,
MI''
in
the
Federal
Register
[
67
FR
47464].
Background
and
Purpose
On
July
12,
2001,
the
Coast
Guard
published
a
final
rule
in
the
Federal
Register
[
66
FR
36484]
amending
the
ratemaking
for
the
Great
Lakes
Pilotage.
The
new
rates
became
effective
August
13,
2001.
Those
rates
were
challenged
in
District
Court
by
the
Lake
Pilots
Association,
representing
the
pilots
in
District
Two.
While
preparing
our
defense,
we
discovered
that
we
had
inadvertently
accounted
for
delay
and
detention
hours
in
District
Two
differently
from
how
we
had
in
Districts
One
and
Three.
We
also
noticed
minor
errors
in
computing
the
rates
in
District
Two.
The
Coast
Guard
has
recently
completed
a
study
that
addresses,
among
other
things,
the
issue
of
how
we
should
count
hours
of
delay
and
detention
when
computing
bridge­
hours
in
all
three
Districts.
Also
the
Coast
Guard
is
currently
in
the
process
of
adjusting
the
pilotage
rates
in
all
three
Districts.
See
[
USCG
 
2002
 
11288].

Discussion
of
Temporary
Rule
We
did
not
publish
a
notice
of
proposed
rulemaking
(
NPRM)
in
order
to
extend
this
temporary
final
rule,
and
it
takes
effect
immediately.
Delay
in
implementing
this
rule
would
be
contrary
to
the
public
interest.
This
rulemaking
will
maintain
the
status
quo
allowing
litigation
and
associated
rulemaking
to
be
completed.
While
not
agreeing
with
the
allegations
contained
in
the
complaint
of
the
Lakes
Pilots'
Association,
for
the
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