Document ID: EPA-HQ-OPP-2003-0136-0001
Agency: epa
Document Type: Rule
Title: Buprofezin; Pesticide Tolerance
Posted Date: 2003-06-25T04:00Z

37765
Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Rules
and
Regulations
§
180.474
[
Amended]


8.
In
§
180.474,
in
the
table
to
paragraph
(
b),
amend
the
entries
for
barley,
grain;
barley,
hay;
barley,
straw;
wheat,
hay;
and
wheat,
straw
by
revising
the
expiration/
revocation
date
``
12/
31/
03''
to
read
``
6/
30/
05''
and
amend
the
entry
for
garlic
by
revising
the
expiration/
revocation
date
``
12/
31/
03''
to
read.
``
12/
31/
05''

§
180.475
[
Amended]


9.
In
§
180.475,
in
the
table
to
paragraph
(
b),
amend
the
entry
for
corn,
sweet,
kernel
plus
cob
with
husks
removed;
corn,
sweet,
forage;
and,
corn,
sweet,
stover
by
revising
the
expiration/
revocation
date
``
12/
31/
03''
to
read
``
12/
31/
05.''

§
180.480
[
Amended]


10.
In
§
180.480,
in
the
table
to
paragraph
(
b),
amend
the
entries
for
cattle,
fat;
cattle,
meat
byproducts;
cattle,
meat;
goat,
fat;
goat,
meat
byproducts;
goat,
meat;
grapefruit;
grapefruit,
dried
pulp;
grapefruit,
oil;
hog,
fat;
hog,
meat
byproducts;
hog,
meat;
horse,
fat;
horse,
meat
byproducts;
horse,
meat;
sheep,
fat;
sheep,
meat
byproducts;
sheep,
meat
by
revising
the
expiration/
revocation
date
``
12/
31/
03''
to
read.
``
12/
31/
05.''

§
180.510
[
Amended]


11.
In
§
180.510,
in
the
table
to
paragraph
(
b),
amend
the
entry
for
bean,
succulent
by
revising
the
expiration/
revocation
date
``
6/
30/
03''
to
read
``
6/
30/
05.''

§
180.515
[
Amended]


12.
In
§
180.515,
in
the
table
to
paragraph
(
b),
amend
the
entry
for
hop,
dried
cone
by
revising
the
expiration/
revocation
date
``
6/
30/
03''
to
read
``
6/
30/
05.''

§
180.516
[
Amended]


12.
In
§
180.516,
in
the
table
to
paragraph
(
b),
amend
the
entry
for
pomegrante
by
revising
the
expiration/
revocation
date
``
6/
30/
03''
to
read
``
6/
30/
06.''

§
180.544
[
Amended]


13.
In
§
180.544,
in
the
table
to
paragraph
(
b),
amend
the
entries
for
soybean,
aspirated
grain
fractions;
soybean,
forage;
soybean,
hay;
soybean,
refined
oil;
soybean,
seed
by
revising
the
expiration/
revocation
date
``
12/
31/
03''
to
read
``
12/
31/
05.''

§
180.557
[
Amended]


14.
In
§
180.515,
in
the
table
to
paragraph
(
b),
amend
the
entries
for
beet,
sugar,
dried
pulp;
beet,
sugar,
molasses;
beet,
sugar,
roots;
beet,
sugar,
tops;
cattle,
fat;
cattle,
kidney;
cattle,
liver;
cattle,
meat;
cattle,
meat
byproducts,
except
kidney
and
liver;
and
milk
by
revising
the
expiration/
revocation
date
``
12/
31/
03''
to
read
``
12/
31/
05.''
[
FR
Doc.
03
 
15906
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0136;
FRL
 
7310
 
7]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
buprofezin
in
or
on
bean,
snap,
succulent;
logan;
lychee;
pistachio;
pulasan;
rambutan;,
and
spanish
lime.
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
June
25,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0136,
must
be
received
on
or
before
August
25,
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:
By
mail:
Shaja
R.
Brothers,
Registration
Division
(
7050C),
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@
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,
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
 
0136.
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
March
26,
2003
(
68
FR
14619)
(
FRL
 
7295
 
8),
EPA
issued
a
notice
pursuant
to
section
408
VerDate
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15:
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24,
2003
Jkt
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E:\
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37766
Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Rules
and
Regulations
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
2E6369,
2E6455,
and
2E6493)
by
IR­
4,
681
U.
S.
Highway
#
1
South,
New
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petition
prepared
by
Nichino
American
Inc.,
the
registrant.
The
petition
requested
that
40
CFR
180.511
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
buprofezin,
buprofezin
(
2­[(
1,1­
dimethylethyl)
imino]
tetrahydro­
3(
1­
methylethyl)­
5­
phenyl­
4H­
1,3,5­
thiadiazin­
4­
one),
in
or
on
bean,
snap,
succulent
at
0.02
parts
per
million
(
ppm);
logan
at
0.30
ppm;
lychee
at
0.30
ppm;
pistachio
at
0.05
ppm;
pulasan
at
0.30
ppm;
rambutan
at
0.30
ppm;
and
spanish
lime
at
0.30
ppm.
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
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
November
26,
1997
(
62
FR
62961)
(
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
buprofezin
on
bean,
snap,
succulent
at
0.02
ppm;
logan
at
0.30
ppm;
lychee
at
0.30
ppm;
pistachio
at
0.05
ppm;
pulasan
at
0.30
ppm;
rambutan
at
0.30
ppm;,
and
spanish
lime
at
0.30
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
these
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
buprofezin
is
discussed
in
Unit
III.
A.
of
the
Final
Rule
on
Buprofezin
Pesticide
Tolerance
published
in
the
Federal
Register
on
September
5,
2001
(
66
FR
46381)
(
FRL
 
6796
 
6).

B.
Toxicological
Endpoints
The
dose
at
which
no
observed
adverse
effects
(
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
observed
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
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
(
aRfD
or
cRfD)
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
(
MOE
cancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
buprofezin
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BUPROFEZIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
females
13
 
50
years
of
age)
NOAEL
=
200
milligrams
kilogram/
day
(
mg/
kg/
day)
UF
=
100
aRfD
=
2.0
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
aRfD
FQPA
SF
=
2.0
mg/
kg/
day
Developmental
toxicity
study­
rats
LOAEL
=
800
mg/
kg/
day
based
on
incomplete
ossification
and
reduced
pup
weight
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25,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BUPROFEZIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
general
population
including
infants
and
children)
N/
A
N/
A
N/
A
Chronic
dietary
(
all
populations)
NOAEL=
1.0
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.01
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.01
mg/
kg/
day
2
 
year
chronic/
feeding
study
­
rat
LOAEL
=
8.7
mg/
kg/
day
based
on
increased
incidence
of
follicular
cell
hyperplasia
and
hypertrophy
in
the
thyroid
in
males
Short­
term
dermal
(
1
to
30
days)
(
Residential)
Dermal
study
NOAEL
=
300
mg/
kg/
day
LOC
for
MOE
=
<
100
(
Residential)
Adults
<
1,000
(
Residential)
Infants/
children
24
 
day
dermal
toxicity
study
­
rat
LOAEL
=
1,000
mg/
kg/
day
based
on
inflammatory
infiltrate
of
the
liver
in
females
and
an
increase
in
acanthosis
and
hyperkeratosis
of
the
skin
in
females
Intermediate­
term
dermal
(
1
week
to
6
months)
(
Residential)
Dermal
study
NOAEL
=
300
mg/
kg/
day
LOC
for
MOE
=
<
100
(
Residential)
Adults
<
1,000
(
Residential)
Infants/
children
24
 
day
dermal
toxicity
study
­
rat
LOAEL
=
1,000
mg/
kg/
day
based
on
inflammatory
infiltrate
of
the
liver
in
females
and
an
increase
in
acanthosis
and
hyperkeratosis
of
the
skin
in
females
Long­
term
dermal
(
several
months
to
lifetime)
(
Residential)
Oral
study
NOAEL
=
1.0
mg/
kg/
day
LOC
for
MOE
=
<
100
(
Residential)
Adults
<
1,000
(
Residential)
Infants/
children
2
 
year
chronic/
feeding
study
­
rat
LOAEL
=
8.7
mg/
kg/
day
based
on
increased
incidence
of
follicular
cell
hyperplasia
and
hypertrophy
in
the
thyroid
in
males
Short­
term
inhalation
(
1
to
30
days)
(
Residential)
Oral
study
NOAEL
=
13.0
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
<
100
(
Residential)
Adults
<
1,000
(
Residential)
Infants/
children
90
 
day
oral
toxicity
study
­
rat
LOAEL
=
68.6
mg/
kg/
day
based
on
organ
weight
changes
and
microscopic
findings
in
the
liver
and
thyroid
of
both
males
and
females
and
in
the
kidney
of
males
Intermediate­
term
inhalation
(
1
week
to
6
months)
(
Residential)
Oral
study
NOAEL
=
13.0
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
<
100
(
Residential)
Adults
<
1,000
(
Residential)
Infants/
children
90
 
day
oral
toxicity
study
­
rat
LOAEL
=
68.6
mg/
kg/
day
based
on
organ
weight
changes
and
microscopic
findings
in
the
liver
and
thyroid
of
both
males
and
females
and
in
the
kidney
of
males
Cancer
(
oral,
dermal,
inhalation)
N/
A
2
 
year
carcinogenicity
study
in
mice
Liver
tumors
observed
in
female
mice
The
Agency
Cancer
Assessment
Review
Committee
recommends
that
no
quantification
of
cancer
risk
is
required.

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.511
for
the
residues
of
buprofezin,
in
or
on
the
following
raw
agricultural
commodities:
Almond,
banana,
citrus
fruits,
cotton,
cucumber,
grape,
lettuce
(
head
and
leaf),
tomato,
melon
(
cantaloupe,
honeydew,
watermelon,
muskmelon),
pumpkin,
and
squash
with
tolerances
for
residues
of
buprofezin
ranging
from
0.05
to
60
ppm.
Tolerances
have
also
been
established
for
residues
of
buprofezin
in/
on
ruminant
fat,
liver,
and
meat
byproducts
at
0.05
ppm.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
buprofezin
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(
USDA)
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
The
acute
dietary
analysis
assumed
tolerance
level
residues,
DEEMTM
(
ver.
7.76)
default
processing
factors,
and
100%
crop
treated
for
all
registered
and
proposed
commodities
(
Tier
I).

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2003
/
Rules
and
Regulations
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment,
the
(
DEEMTM­
FCID)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996,
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
The
chronic
dietary
exposure
assumed
100%
crop
treated
and
DEEMTM­
FCID
(
ver.
1.30)
default
processing
factors
for
all
registered/
proposed
commodities
and
tolerance
level
residues
for
all
registered/
proposed
commodities
excluding
banana,
orange,
and
tomato
processed
and
unprocessed
commodities
where
average
field
trial
residues
were
assumed
(
Tier
II).
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
buprofezin
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
buprofezin.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
Screening
Concentration
in
Ground
Water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screening­
level
assessment
for
surface
water,
EPA
will
use
FIRST
(
a
Tier
I
model)
before
using
PRZM/
EXAMS
(
a
Tier
II
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
and
include
a
percent
crop
(
PC)
area
factor
as
an
adjustment
to
account
for
the
maximum
PC
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
population
adjusted
dose
(%
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
buprofezin,
they
are
further
discussed
in
the
aggregate
risk
section
under
Unit
III.
E.
Based
on
the
FIRST
and
SCI­
GROW
models,
the
EECs
of
buprofezin
for
acute
exposures
are
estimated
to
be
102
parts
per
billion
(
ppb)
for
surface
water
and
0.08
ppb
for
ground
water.
The
EECs
for
chronic
surface
water
and
ground
water
exposures
are
estimated
to
be
34
ppb,
and
0.08
ppb,
respectively.
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).
Buprofezin
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
exposure
to
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
buprofezin
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
buprofezin
and
any
other
substances
and
buprofezin
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
buprofezin
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
MOS
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
MOS
will
be
safe
for
infants
and
children.
MOS
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
UF
(
safety)
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
Agency
concluded
that
the
available
studies
provided
no
indication
of
increased
susceptibility
of
rats
or
rabbits
following
in
utero
exposure
or
of
rats
following
prenatal/
postnatal
exposure
to
buprofezin.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
buprofezin
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.
The
FQPA
factor
is
reduced
to
1X
based
on
toxicological
considerations
and
based
on
the
conservative
residue
assumptions
used
in
the
dietary
risk
assessment
(
currently
no
residential
exposures)
and
the
completeness
of
the
toxicity,
residue
chemistry
and
environmental
fate
data
base
(
evaluated
by
EPA).

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
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/
Rules
and
Regulations
available
for
exposure
through
drinking
water
e.
g.,
allowable
water
exposure
(
mg/
kg/
day)
=
PAD
­
(
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
EPA's
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female
and
youth),
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
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,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
buprofezin
will
occupy
1%
of
the
aPAD
for
the
females
13
 
49
years
old.
No
effect
that
could
be
attributed
to
a
single
exposure
was
observed,
(
no
endpoint
was
chosen)
for
the
general
U.
S.
population
(
including
infants
and
children).
In
addition,
there
is
potential
for
acute
dietary
exposure
to
buprofezin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
the
following
Table
2:

TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
BUPROFEZIN
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females
(
13
 
49
years
old)
2.0
1
102
0.08
59,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
buprofezin
from
food
will
utilize
32%
of
the
cPAD
for
the
U.
S.
population,
18%
of
the
cPAD
for
infants
<
1
year
old,
and
63%
of
the
cPAD
for
children
1
 
2
years
old.
There
are
no
residential
uses
for
buprofezin
that
result
in
chronic
residential
exposure
to
buprofezin.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
buprofezin
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
3:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
BUPROFEZIN
Population
Subgroup
cPAD
mg/
kg/
day
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
population
0.01
32
34
0.08
240
All
infants
(<
1
year
old)
0.01
18
34
0.08
83
Children
(
1
 
2
years
old)
0.01
63
34
0.08
37
Females
(
13
 
years
old)
0.01
30
34
0.08
210
3.
Aggregate
cancer
risk
for
U.
S.
population.
In
accordance
with
the
EPA
Guidelines
for
Carcinogen
Risk
Assessment,
the
Carcinogen
Assessment
Review
Commission
classified
buprofezin
as
having
``
suggestive
evidence
of
carcinogenicity,
but
not
sufficient
to
assess
human
carcinogenic
potential''
based
on
liver
tumors
in
female
mice.
The
Committee
further
recommended
no
quantification
of
cancer
risk.
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
buprofezin
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
gas
chromotography
using
nitrogen
phosphorus
detection
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;
email
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
Canada,
Codex,
and
Mexico
do
not
have
maximum
residue
limits
for
residues
of
buprofezin
in/
on
the
proposed
crops.
Therefore,
harmonization
is
not
an
issue.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
buprofezin,
[(
2­[(
1,1­
dimethylethyl)
imino]
tetrahydro­
3(
1­
methylethyl)­
5­
phenyl­
4H­
1,3,5­

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25,
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and
Regulations
thiadiazin­
4­
one)],
in
or
on
bean,
snap,
succulent
at
0.02
ppm;
logan
at
0.30
ppm;
lychee
at
0.30
ppm;
pistachio
at
0.05
ppm;
pulasan
at
0.30
ppm;
rambutan
at
0.30
ppm;
spanish
lime
at
0.30
ppm
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
to
``
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
 
0136
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
August
25,
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
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
 
0136,
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.
Statuatory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
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
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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
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.''
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.

Dated:
June
6,
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
180.511
is
amended
by
alphabetically
adding
the
following
commodities
to
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.511
Tolerances
are
established
for
residues
of
buprofezin
in
or
on
the
following
food
commodities.

(
a)
*
*
*

Commodity
Parts
per
million
Expiration/
Revocation
Date
*
*
*
*
*
*
*
Bean,
snap,
succulent
.............................................................................................................
0.02
None
*
*
*
*
*
*
*
Logan
.......................................................................................................................................
0.30
None
Lychee
.....................................................................................................................................
0.30
None
*
*
*
*
*
*
*
Pistachio
..................................................................................................................................
0.05
None
Pulasan
....................................................................................................................................
0.30
None
Rambutan
................................................................................................................................
0.30
None
*
*
*
*
*
*
*
Spanish
lime
............................................................................................................................
0.30
None
*
*
*
*
*
*
*

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Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Rules
and
Regulations
*
*
*
*
*
[
FR
Doc.
03
 
15767
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
25
[
IB
Docket
98
 
21;
FCC
02
 
110]

Policies
and
Rules
for
the
Direct
Broadcast
Satellite
Service;
Correction
AGENCY:
Federal
Communications
Commission.
ACTION:
Correcting
amendments.

SUMMARY:
This
document
contains
a
correction
to
final
regulations
which
were
published
Wednesday,
August
7,
2002
(
67
FR
51110).
The
regulations
relates
to
Policy
and
Rules
for
the
Direct
Broadcast
Satellite
Service.
DATES:
Effective
June
25,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Selina
Y.
Khan,
Attorney
Advisor,
Satellite
Division,
International
Bureau,
telephone
(
202)
418
 
7282
or
via
the
Internet
at
skhan@
fcc.
gov.
SUPPLEMENTARY
INFORMATION:

Background
The
final
rule
document
published
on
Wednesday,
August
7,
2002
publishes
47
CFR
25.114
by
adding
paragraph
(
c)(
22)
instead
of
paragraph
(
c)(
23).

Need
for
Correction
As
published,
the
final
regulations
contain
an
error
which
may
prove
to
be
misleading
and
are
in
need
of
clarification.

List
of
Subjects
in
47
CFR
Part
25
Satellites.

Federal
Communications
Commission.
Marlene
H.
Dortch,
Secretary.


Accordingly,
47
CFR
part
25
is
corrected
by
making
the
following
correcting
amendments:

PART
25
 
SATELLITE
COMMUNICATIONS

1.
The
authority
citation
for
part
25
continues
to
read
as
follows:

Authority:
U.
S.
C.
701744.
Interprets
or
applies
47
U.
S.
C.
51,
154,
302,
303,
and
307,
unless
otherwise
noted.

§
25.114
[
Amended]


2.
Amend
§
25.114
by
redesignating
the
second
paragraph
(
c)(
22)
as
paragraph
(
c)(
23).

[
FR
Doc.
03
 
15963
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
6712
 
01
 
P
DEPARTMENT
OF
COMMERCE
National
Oceanic
and
Atmospheric
Administration
50
CFR
Part
635
[
Docket
No.
030617153
 
3153
 
01;
I.
D.
061203E]

RIN
0648
 
AR29
Atlantic
Highly
Migratory
Species
(
HMS)
Fisheries;
Vessel
Monitoring
Systems
(
VMS)

AGENCY:
National
Marine
Fisheries
Service
(
NMFS),
National
Oceanic
and
Atmospheric
Administration
(
NOAA),
Department
of
Commerce.
ACTION:
Final
rule;
amendment
of
effective
date.

SUMMARY:
This
document
amends
the
effective
date
for
the
requirement
to
have
a
NOAA­
approved,
VMS
unit
installed
and
operating
on
any
vessel
leaving
port
to
fish
for
HMS
with
pelagic
longline
gear
on
board
to
September
1,
2003.
DATES:
Effective
September
1,
2003.
ADDRESSES:
To
obtain
copies
of
the
list
of
NOAA­
approved
VMS
mobile
transmitting
units
and
NOAA­
approved
VMS
communications
service
providers,
write
to
NMFS
Office
for
Law
Enforcement
(
OLE),
8484
Georgia
Avenue,
Suite
415,
Silver
Spring,
MD
20910.

FOR
FURTHER
INFORMATION
CONTACT:
For
information
regarding
the
requirement
contact
Chris
Rilling,
Highly
Migratory
Species
Management
Division
(
F/
SF1),
Office
of
Sustainable
Fisheries,
National
Marine
Fisheries
Service,
1315
East­
West
Highway,
Silver
Spring,
MD
20910,
phone
301
 
713
 
2347.
For
current
listing
of
approved
VMS
units
contact
Mark
Oswell,
Outreach
Specialist,
phone
301
 
427
 
2300,
fax
301
 
427
 
2055.
For
questions
regarding
VMS
installation
and
activation
checklists,
contact
Jonathan
Pinkerton,
National
VMS
Program
Manager,
phone
301
 
427
 
2300,
fax
301
 
427
 
2055.
The
public
may
acquire
this
notice,
installation
checklist,
and
relevant
updates
via
the
``
fax­
back''
service,
or
at
the
OLE
website
http://
www.
nmfs.
noaa.
gov/
ole/
vms.
html.

SUPPLEMENTARY
INFORMATION:
On
May
28,
1999,
NMFS
issued
a
regulation
(
64
FR
29090)
codified
at
50
CFR
635.69(
a),
requiring
all
commercial
pelagic
longline
vessels
fishing
for
Atlantic
HMS
to
install
a
NMFS­
approved
VMS
unit.
Due
to
litigation,
the
requirement
was
stayed
indefinitely
on
October
1,
2000
(
66
FR
1907,
January
10,
2001).
On
October
15,
2002,
the
U.
S.
District
Court
for
the
District
of
Columbia
issued
a
final
order
upholding
the
VMS
regulation.
Following
the
favorable
court
ruling,
NMFS
began
working
to
reinstate
the
VMS
requirement.
On
March
11,
2003,
NMFS
published
a
notice
in
the
Federal
Register
(
68
FR
11534)
and
corrected
it
on
March
27,
2003
(
68
FR
14949),
to
provide
a
list
of
the
NMFS­
approved
VMS
units
for
use
by
pelagic
longline
vessels
in
the
Atlantic
Highly
Migratory
Species
(
HMS)
Fisheries
and
set
forth
relevant
features
of
each
VMS.
The
notification
was
issued
to
update
and
replace
the
approval
notice
published
on
September
9,
1999.
An
additional
type
approval
notice
was
published
on
May
1,
2003
(
68
FR
23285).
NMFS
also
submitted
a
request
to
the
Office
of
Management
and
Budget
(
OMB)
to
reinstate
approval
for
VMS
information
collection
under
the
provisions
of
the
Paperwork
Reduction
Act.
A
notice
regarding
this
collection
was
published
in
the
Federal
Register
on
November
18,
2002
(
67
FR
69506).
The
second
notice
of
OMB
review
was
published
in
the
Federal
Register
on
March
19,
2003
(
68
FR
13280).
OMB
approved
the
VMS
information
collection
request
on
May
10,
2003.
The
placement
of
VMS
units
on
fishing
vessels
in
this
fishery
will
enable
NMFS
to
determine
vessel
locations
and
will
complement
the
Agency's
efforts
to
monitor
and
enforce
compliance
with
applicable
regulations.
Because
fishermen
need
time
to
purchase
and
install
VMS,
the
VMS
rule
will
be
effective
September
1,
2003,
which
provides
approximately
60
days
for
affected
fishermen
to
come
into
compliance.

Classification
This
action
is
published
under
the
authority
of
the
Magnuson­
Stevens
Fishery
Conservation
and
Management
Act.
The
Assistant
Administrator
(
AA)
has
determined
that
implementation
of
a
VMS
program
in
the
pelagic
longline
fishery
is
necessary
to
monitor
and
enforce
closed
areas
implemented
to
reduce
bycatch.
The
AA
finds
that
good
cause
exists
to
waive
the
requirement
to
provide
prior
notice
and
the
opportunity
for
comment,
pursuant
to
authority
set
forth
at
5
U.
S.
C.
553(
b)(
B),
as
such
procedures
would
be
unnecessary
and
contrary
to
the
public
interest.
This
amendment
establishes
a
new
effective
date
for
the
HMS
VMS
rule,
which
had
been
suspended
due
to
litigation.
NMFS
provided
for
prior
notice
and
comment
before
promulgating
the
HMS
VMS
rule
in
1999,
then
provided
for
additional
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