Document ID: EPA-HQ-OPP-2002-0224-0001
Agency: epa
Document Type: Rule
Title: Diflubenzuron; Pesticide Tolerance
Posted Date: 2002-09-19T04:00Z

59006
Federal
Register
/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
now
state:
``
Clean
Air
Act
Redesignation
and
Reclassification,
Searles
Valley
Nonattainment
Area;
Designation
of
Coso
Junction,
Indian
Wells
Valley,
and
Trona
Nonattainment
Areas;
California;
Determination
of
Attainment
of
the
PM
 
10
Standards
for
the
Trona
Area;
Particulate
Matter
of
10
microns
or
less
(
PM
 
10).''
Under
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
and
is
therefore
not
subject
to
review
by
the
Office
of
Management
and
Budget.
In
addition,
this
action
does
not
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Public
Law
104
 
4),
or
require
prior
consultation
with
State
officials
as
specified
by
Executive
Order
12875
(
58
FR
58093,
October
28,
1993),
or
involve
special
consideration
of
environmental
justice
related
issues
as
required
by
Executive
Order
12898
(
59
FR
7629,
February
16,
1994).
Because
this
action
is
not
subject
to
notice­
and­
comment
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute,
it
is
not
subject
to
the
provisions
of
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.).
Under
5
U.
S.
C.
801(
a)(
1)(
A)
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
EPA
submitted
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
General
Accounting
Office
prior
to
publication
of
this
rule
in
today's
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
81
Environmental
protection,
Air
pollution
control,
National
parks,
Wilderness
areas.

Dated:
September
9,
2002.
Wayne
Nastri,
Regional
Administrator,
Region
IX.
[
FR
Doc.
02
 
23730
Filed
9
 
18
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0224;
FRL
 
7200
 
4]

Diflubenzuron;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
tolerances
for
the
combined
residues
of
the
insecticide
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide)
and
its
metabolites,
4­
chlorophenylurea
(
CPU)
and
4­
chloroaniline
(
PCA)
in
or
on
the
following
raw
agricultural
commodities:
Grass,
forage,
fodder,
and
hay
group
17
at
6.0
ppm;
pepper
at
1.0
ppm;
stone
fruit
group
12
(
except
cherries)
at
0.07
ppm;
nut,
tree,
group
14
at
0.06
ppm;
almond,
hulls
at
6.0
ppm;
pistachio
at
0.06
ppm;
cattle,
meat
byproducts
at
0.15
ppm;
goat,
meat
byproducts
at
0.15
ppm;
hog,
meat
byproducts
at
0.15
ppm;
horse,
meat
byproducts
at
0.15
ppm;
sheep,
meat
byproducts
at
0.15
ppm.
This
regulation
is
increasing
the
tolerance
level
for
meat
byproducts
of
cattle,
goat,
hog,
horse,
and
sheep.
This
regulation
is
also
changing
the
tolerance
on
pasture
grass
to
grass,
forage,
fodder,
and
hay
group
17.
Interregional
Research
Project
Number
4
(
IR­
4),
and
Uniroyal
Chemical
Company
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.

DATES:
This
regulation
is
effective
September
19,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP
 
2002
 
0224,
must
be
received
on
or
before
November
18,
2002.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP
 
2002
 
0224
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Rita
Kumar,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
 
8291;
e­
mail
address:
kumar.
rita@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations'',
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP
 
2002
 
0224.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
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Register
/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
December
14,
2001
(
66
FR
64823)
(
6813
 
2),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP
1E6347
and
1F6235)
by
Interregional
Research
Project
Number
4
(
IR­
4),
and
Uniroyal
Chemical
Company
Inc.,
681
US
Highway
1
South,
North
Brunswick,
NJ
08902,
and
Middlebury,
CT
06749.
This
notice
included
a
summary
of
the
petitions
prepared
by
IR­
4
and
Uniroyal
Chemical
Company,
the
registrants.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.377
be
amended
by
establishing
a
tolerance
for
the
combined
residues
of
the
insecticide
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide)
and
its
metabolites,
4­
chlorophenylurea
(
CPU)
and
4­
chloroaniline
(
PCA),
in
or
on
grass,
forage,
fodder,
and
hay,
group
17
at
6.0
part
per
million
(
ppm);
pepper
at
1.0
ppm;
stone
fruit
group
(
except
cherries)
at
0.05
ppm;
tree
nut
group
at
0.05
ppm;
almond,
hulls
at
5.0
ppm;
pistachio
at
0.05
ppm;
and
meat
byproducts
at
0.15
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)
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)
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
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D),
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),
for
a
tolerance
for
residues
of
the
insecticide
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide)
and
its
metabolites,
4­
chlorophenylurea
(
CPU)
and
4­
chloroaniline
(
PCA)
on
grass,
forage,
fodder,
and
hay
group
at
6.0
ppm;
pepper
at
1.0
ppm;
stone
fruit
group
(
except
cherries)
at
0.07
ppm;
tree
nut
group
at
0.06
ppm;
almond
hulls
at
6.0
ppm;
pistachio
at
0.06
ppm;
cattle,
meat
byproducts
at
0.15
ppm;
goat,
meat
byproducts
at
0.15
ppm;
hog,
meat
byproducts
at
0.15
ppm;
horse,
meat
byproducts
at
0.15
ppm;
sheep,
meat
byproducts
at
0.15
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
follows.

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
diflubenzuron
are
discussed
in
the
following
Table
1
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
NOAEL
<
8
mg/
kg/
day
LOAEL
=
8
mg/
kg/
day
based
on
increased
methemoglobinemia,
and
signs
of
hemolytic
anemia,
erythrocyte
destruction
in
the
spleen
and
liver
and
regeneration
of
erythrocytes
in
the
bone
marrow.

870.3150
90
 
Day
oral
toxicity
in
nonrodents
NOAEL
=
2
mg/
kg/
day
LOAEL
=
6.24
mg/
kg/
day
based
on
methemoglobinemia.

870.3200
21/
28
 
Day
dermal
toxicity
NOAEL
=
500
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
methemoglobinemia
(
limit
dose).

870.3465
28
 
Day
inhalation
toxicity
NOAEL
=
20.3
mg/
kg/
day
highest
dose
tested
(
HDT)
LOAEL
was
not
established.

870.3700
Prenatal
developmental
in
rodents
Maternal
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.
Developmental
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.

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Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3700
Prenatal
developmental
in
nonrodents
Maternal
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.
Developmental
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.

870.3800
Reproduction
and
fertility
effects
Parental/
Systemic
NOAEL
<
36
mg/
kg/
day
(
LDT)
LOAEL
=
36
mg/
kg/
day
based
on
dose­
related
decreased
hematocrit,
hemoglobin
concentration,
red
blood
cell
count
and
an
increase
in
percent
methemoglobin,
changes
in
cell
morphology
and
brown
pigment
in
Kupffer
cells.
Reproductive
NOAEL>
4254
mg/
kg/
day
(
HDT)
LOAEL
was
not
established.
Offspring
NOAEL
=
427
mg/
kg/
day
LOAEL
=
4254
mg/
kg/
day
based
on
Significant
decrease
in
F­
1
pup
weights
on
day
4,
8
and
21
of
lactation.

870.4100
Chronic
toxicity
dogs
NOAEL
=
2
mg/
kg/
day
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia.

870.4200
Carcinogenicity
rats
NOAEL
was
not
established
LOAEL
=
7.8
mg/
kg/
day
based
on
histological
evidence
of
erythrocyte
destruction
and
compensatory
regeneration.
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
mice
NOAEL
=
2.4
mg/
kg/
day
LOAEL
=
12
mg/
kg/
day
based
on
increased
methemoglobin
and
sulfhemoglobin
levels.
No
evidence
of
carcinogenicity
870.5100
Gene
Mutation
Salmonella
strains
TA98,
TA100,
TA1535,
TA1537
and
TA1538
exposed
to
diflubenzuron
in
DMSO
at
doses
of
0
to
1,000
µ
g/
plate
both
in
the
presence
and
absence
of
S9
did
not
induce
mutations.

870.5375
Cytogenetics
Chinese
hamster
ovary
cells
in
vitro
exposure
to
diflubenzuron
in
DMSO
at
dose
levels
of
200
to
250
µ
g/
mL
both
in
the
presence
and
absence
of
S9
did
not
induce
an
increase
in
chromosomal
aberrations.

870.5550
Other
Effects
In
the
UDS
assay
primary
rat
hepatocytes
exposed
to
diflubenzuron
in
DMSO
at
dose
levels
of
0.1
to
333
µ
g/
mL
did
not
induce
unscheduled
DNA
syntheses.

870.7485
Metabolism
and
pharmacokinetics
[
14C­
anilino]­
diflubenzuron
was
completely
absorbed
and
87%
of
radioactivity
was
recovered
in
the
urine
and
feces
as
parent,
diflubenzuron
by
96
hours
post­
dosing.
Diflubenzuron
did
not
metabolize
to
4­
chloroaniline
(
CPA),
or
chlorophenylurea
(
CPU);
the
former
was
associated
with
methemoglobin
formation
and
tumor
formation
in
rats
and
mice
in
the
NTP
study.
[
U­
14C­
phenyl]­
chlorophenylurea
(
CPU)
was
completely
absorbed
and
91%
of
the
dose
was
eliminated
in
urine
and
feces
by
144
hours.
Unmetabolized
CPU
was
not
identified
in
urine
or
feces.
Most
of
urinary/
fecal
metabolites
were
sulfate
or
glucuronide
conjugates
of
CPU.

870.7600
Dermal
penetration
Dermal
application
of
14C)
diflubenzuron
at
either
0.005
or
0.05
mg/
cm.
sq.
resulted
in
less
than
0.5%
absorption
at
any
dose
level
after
1,
4
or
10
hours
of
exposure.

N/
A
Special
studies
In
acute
oral
toxicity
study
in
rats
CPA
at
62
mg/
kg
caused
significant
increase
in
methemoglobinemia
while
CPU
at
200
mg/
kg
did
not
cause
methemoglobinemia.

B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
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
intra
species
differences.
The
FQPA
Safety
Factor
Committee
(
SFC)
recommended
that
the
FQPA
safety
factor
used
in
human
health
risk
assessments
(
as
required
by
FQPA
of
August
3,
1996)
be
removed
(
reduced
to
1x)
in
assessing
the
risk
posed
by
this
chemical.
Consequently,
the
current
cRfD
and
cPAD
values
are
equivalent
(
0.02
mg/
kg/
day).
This
decision
was
based
on
the
following:
1.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
2.
A
developmental
neurotoxicity
study
(
DNT)
with
diflubenzuron
is
not
required;
3.
Food
and
drinking
water
exposure
assessments
will
not
underestimate
the
potential
exposure
for
infants
and
children;
and
4.
There
are
currently
no
registered
or
proposed
residential
(
non­
occupational)
uses
of
diflubenzuron.
Although
there
are
no
registered
homeowner
uses,
there
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is
potential
for
professional
applications
to
outdoor
residential
and
recreational
areas
to
control
mosquitos,
moths,
and
other
insects.
However,
the
potential
for
post­
application
residential
exposures
are
expected
to
be
limited.
Due
to
the
low
dermal
absorption
rate
(
0.5%)
of
diflubenzuron,
and
since
it
is
only
applied
to
the
tree
canopy,
minimal
bystander
contact
is
expected.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
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
Safety
Factor.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
diflubenzuron
and
its
metabolites
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
DIFLUBENZURON
AND
ITS
METABOLITES
FOR
USE
IN
HUMAN
RISK
ASSESSMENT1.

Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF**
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
all
populations
Not
Applicable
Not
Applicable
No
appropriate
endpoint
attributable
to
single
exposure
was
available
in
oral
studies.
Therefore
a
risk
assessment
is
not
required.

Chronic
Dietary
(
All
populations)
NOAEL=
2
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.02
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD/
FQPA
SF
=
0.02
mg/
kg/
day
Chronic
Toxicity
Study
­
Dog
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia
Short­
and
Intermediate­
Term
Incidental
Oral
(
1
day
 
6
months)
(
Residential)
Not
applicable
Not
applicable
These
endpoints
were
not
evaluated.
There
are
no
registered
uses
of
diflubenzuron
which
result
in
significant
residential
exposure.

Short­
Term
Dermal
(
1
 
30
days)
(
Occupational)
NOAEL
=
500
mg/
kg/
day
LOC
for
MOE
=
100
21­
Day
dermal
rat
LOAEL
=
1,000
mg/
kg/
day
based
on
methemoglobinemia
Intermediate­
Term
Dermal
(
1
 
6
months)
(
Occupational)
NOAEL
=
2
mg/
kg/
day
LOC
for
MOE
=
100
13
­
week
oral
dog
LOAEL
=
6.4
mg/
kg/
day
based
on
methemoglobinemia
Long­
Term
Dermal
(
Longer
than
6
months)
(
Occupational)
NOAEL
=
2
mg/
kg/
day
LOC
for
MOE
=
100
Chronic
Toxicity
Study
­
Dog
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia
Short­
Term
Inhalation
(
1
 
30
days)
(
Occupational)
NOAEL
=
20.302
mg/
kg/
day
LOC
for
MOE
=
100
28
 
day
Inhalation
Toxicity
Study
­
Rat/
21
 
day
Inhalation
Toxicity
Study
­
Rat
LOAEL
=
0.12
mg/
L
based
on
methemoglobinemia
(
21
 
day
study)

Intermediate­
Term
Inhalation
(
1
 
6
months)
(
Occupational)
NOAEL
=
20.302
mg/
kg/
day
LOC
for
MOE
=
100
28
 
day
Inhalation
Toxicity
Study
­
Rat/
21
 
day
Inhalation
Toxicity
Study
­
Rat
LOAEL
=
0.12
mg/
L
based
on
methemoglobinemia
(
21
 
day
study)

Long
­
Term
Inhalation
(
Longer
than
6
months)
(
Occupational)
NOAEL
=
2
mg/
kg/
day
LOC
for
MOE
=
100
(
Occupational
Chronic
Toxicity
Study
­
Dog
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia
Cancer
(
Oral,
dermal,
inhalation)
Diflubenzuron
Not
Required
Not
Applicable
Acceptable
oral
rat
and
mouse
carcinogenicity
studies;
no
evidence
of
carcinogenic
or
mutagenic
potential.
Group
E
evidence
of
non­
carcinogenicity
for
humans.

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and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
DIFLUBENZURON
AND
ITS
METABOLITES
FOR
USE
IN
HUMAN
RISK
ASSESSMENT1.
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF**
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
Oral,
dermal,
inhalation)
PCA
Group
B2
probably
human
carcinogen
Q1*
1.12
x
1­
1
(
mg/
kg/
day)­
1
Not
Applicable
NTP
Oral
mouse
study
Cancer
(
Oral,
dermal,
inhalation)
CPU
Q1*
based
on
monuron
a
structural
analog
and
the
Q1*
1.52
x
10­
2
Not
Applicable
NTP
Oral
rat
study
1UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
cPAD
=
chronic
population
adjusted
dose,
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern.
2Conversion
from
mg/
L
to
oral
dose
(
mg/
kg/
day)
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
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
180.377)
for
the
combined
residues
of
the
insecticide
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide
and
its
metabolites,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
diflubenzuron
and
its
metabolites
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
one
day
or
single
exposure.
Acute
doses
and
endpoints
were
not
selected
for
the
general
U.
S.
population
(
including
infants
and
children)
or
the
females
13
 
50
years
old
population
subgroup
for
diflubenzuron;
therefore,
an
acute
dietary
exposure
analysis
was
not
performed.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
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
chronic
exposure
assessments:
For
the
chronic
analysis,
anticipated
residue
(
AR)
information
based
on
field
trial
data
and
percent
crop
treated
(%
CT)
information
for
some
commodities
were
used.
Dietary
exposure
estimates
for
representative
population
subgroups
are
presented
in
Table
3.
Chronic
exposure
estimates
are
expressed
in
mg/
kg
bw/
day
and
as
a
percent
of
the
cPAD.
The
chronic
dietary
risk
assessment
also
indicates
that
for
all
included
commodities,
the
chronic
dietary
risk
estimates
are
below
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(<
1.0%
of
the
cPAD)
and
all
population
subgroups.
The
chronic
dietary
exposure
estimate
for
the
highest
exposed
population
subgroup
(
all
infants
(<
1
year
old))
is
5.5%
of
the
cPAD.

TABLE
3.
 
RESULTS
OF
CHRONIC
DIETARY
EXPOSURE
ANALYSIS.

Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
Total)
0.02
0.000153
<
1.0
All
Infants
(>
1
year
old)
0.02
0.001109
5.5
Children
1
 
6
years
old
0.02
0.000248
1.2
Children
7
 
12
years
old
0.02
0.000199
1.0
Females
13
 
50
years
old
0.02
0.000112
<
1.0
Males
13
 
19
years
old
0.02
0.000065
<
1.0
Males
20+
years
old
0.02
0.000124
<
1.0
Seniors
55+
years
old
0.02
0.000144
<
1.0
iii.
Cancer.
In
1995,
based
on
the
available
evidence,
which
included
carcinogenicity
studies
in
rats
and
mice,
and
battery
of
negative
mutagenicity
studies,
diflubenzuron
was
classified
as
Group
E,
evidence
of
noncarcinogenicity
for
humans.
Rat
metabolism
data
generated
at
this
time
also
indicated
that
diflubenzuron
was
metabolized
to
PCA
and
CPU
and
estimated
to
be
about
2%
of
in
vivo
conversion.
At
that
time,
EPA
also
considered
the
carcinogenicity
of
PCA,
a
known
diflubenzuron
metabolite,
that
was
tested
by
the
NTP
in
1989
for
carcinogenicity
in
rats
and
mice
as
a
hydrochloride
form.
In
rats
treated
with
PCA,
a
treatment­
related
increased
incidence
of
uncommon
sarcomas
of
the
spleen
was
observed
in
males
and
included
fibrosarcomas,
hemangiosarcomas,
and
osteosarcomas,
many
of
which
metastasized
to
other
sites.
In
addition,
in
treated
females,
one
fibrosarcoma
and
one
osteosarcoma
were
also
observed.
Furthermore,
there
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/
Thursday,
September
19,
2002
/
Rules
and
Regulations
was
a
marginally­
increased
incidence
of
pheochromocytomas
in
the
adrenal
glands
in
both
males
and
females
at
the
HDT.
In
mice
treated
with
PCA,
a
treatment­
related
increased
incidence
of
combined
hepatocellular
adenomas/
carcinomas
was
observed
in
males.
The
increase
in
combined
tumors
was
primarily
due
to
a
dose­
related
increase
in
hepatocellular
carcinomas.
Many
of
these
tumors
metastasized
to
the
lungs.
An
increased
incidence
of
hemangiosarcomas
in
the
spleen
and/
or
liver
of
the
male
mice
was
also
observed
at
the
HDT.
The
incidence
was
higher
than
the
historical
control
mean
for
male
mice.
There
was
no
evidence
of
a
carcinogenic
response
in
female
mice.
On
this
basis
PCA
was
classified
as
a
Group
B2,
probable
human
carcinogen.
Recently
submitted
tier
2
rat
metabolism
data
indicate
that
diflubenzuron
does
not
metabolize
to
PCA
or
CPU
nor
is
CPU
converted
to
PCA.
The
Agency
concluded
that
a
2%
in
vivo
conversion
factor
for
diflubenzuron
to
PCA
or
CPU
should
be
dropped.
It
was
recommended
that
noncarcinogenic
risk
assessment
should
include
parent,
CPU
and
PCA;
and
cancer
risk
for
CPU
and
PCA
should
be
assessed
individually.
The
Q1*
(
estimated
unit
risk)
for
PCA,
based
on
male
mouse
liver
adenoma
and/
or
carcinoma
combined
tumor
rates
was
calculated
to
be
1.12
x
10­
1
(
mg/
kg/
day)­
1
in
human
equivalents.
CPU
is
structurally
related
to
monuron
(
N,
N­
dimethyl­
CPU),
a
compound
producing
tumors
of
the
kidney
and
liver
in
male
rats.
Given
that
there
is
no
accepted
mechanism
of
carcinogenicity
for
monuron
and
that
CPU
is
major
metabolite
of
monuron
in
rats,
a
Q1*
was
calculated
for
monuron
and
applied
to
CPU.
The
most
potent
Q1*
for
monuron,
based
on
male
rat
liver
neoplastic
nodule
and/
or
carcinoma
combined
tumor
rats,
was
calculated
to
be
1.52
x
10­
2
(
mg/
kg/
day)­
1
in
human
equivalents.
Although
CPU
is
structurally
related
to
monuron,
there
is
no
need
to
assess
aggregate
or
cumulative
risk
scenarios
using
monuron
because
monuron
is
no
longer
a
registered
pesticide
active
ingredient.
a.
Cancer
risk
from
consumption
of
PCA
and
CPU.
Based
on
the
submitted
metabolism
studies,
there
are
two
possible
sources
for
dietary
exposure
to
PCA
and
CPU:
Residues
in
plants/
fungi
(
mushrooms)
and
residues
in
animal
commodities
(
milk
and
liver).
b.
Mushrooms/
Milk/
Liver.
EPA
used
results
from
metabolism
studies
to
determine
the
percent
of
the
total
radioactive
residue
(
TRR)
present
as
PCA+
CPU
in
mushrooms,
milk
and
liver.
For
milk
and
liver,
ARs
were
calculated
from
the
results
of
the
ruminant
feeding
study
using
tolerance
level
residues
in
livestock
feed
items
and
adjusting
for
percent
crop
treated.
The
total
levels
of
PCA+
CPU
were
estimated
by
multiplying
the
ratio
of
(
PCA+
CPU)/
Diflubenzuron
by
the
diflubenzuron
consumption
(
from
DEEM).
The
U.
S.
population
exposure
to
PCA
and
CPU
is
given
in
Table
4
as
follows.

TABLE
4.
 
DIETARY
CANCER
EXPOSURE
(
TO
PCA
AND
CPU).

Commodity
(
PCA+
CPU)/
Diflubenzuron
Ratio
Diflubenzuron
Consumption
mg/
kg/
day
PCA+
CPU
Consumption
mg/
kg/
day
CPU/(
PCA+
CPU)
Ratio
PCA
Consumption
mg/
kg/
day
CPU
Consumption
mg/
kg/
day
Mushrooms
3.45
0.0000018
0.0000062
0.331
0.0000042
0.00000205
Milk
1.33
0.0000003
0.0000004
1.02
0
0.0000004
Liver
0.21
0.0000008
0.00000017
0.97
5
x
10­
9
0.00000016
Total
0.0000068
0.0000042
0.0000026
1Worst
case
ratio.
Overall
U.
S.
exposure
to
PCA
(
Table
4):
0.0000042
mg/
kg/
day
Carcinogenic
Risk:
4.7
x
10­
7
(
0.0000042
mg/
kg/
day
x
0.112
(
mg/
kg/
day)­
1)
Overall
U.
S.
exposure
to
CPU
(
Table
4):
0.0000026
mg/
kg/
day
Carcinogenic
Risk:
3.9
x
10­
87
(
0.0000026
mg/
kg/
day
x
0.0152
(
mg/
kg/
day)­
1)

The
Agency
does
not
consider
the
cancer
dietary
risk
from
either
PCA
or
CPU
to
exceed
the
Agency's
level
of
concern
(
generally,
in
the
range
of
10­
6).
iv.
Anticipated
residue
and
percent
crop
treated
information.
Section
408(
b)(
2)(
E)
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E),
EPA
will
issue
a
data
callin
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
percent
crop
treated
(
PCT)
as
required
by
section
408(
b)(
2)(
F),
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
percent
crop
treated
(
PCT)
information
as
follows.
Dietary
exposure
estimates
were
based
on
the
following
percent
crop
treated
(
PCT)
estimates:
Grass,
1%;
grapefruit,
8%;
mushrooms,
31%;
oranges,
2%;
tangerines,
4%;
cottonseed
oil
and
meal,
2%;
soybean,
1%;
cattle
bolus,
5%,
walnuts
50%.
Other
commodities
were
assumed
to
be
100
percent
treated.
Anticipated
residue
levels
for
diflubenzuron
were
calculated
in
livestock,
citrus
and
mushroom
commodities.
Anticipated
residue
estimates
for
diflubenzuron
were
not
calculated
for
other
raw
agricultural
commodities.
Percent
crop
treated
data
were
utilized
where
available.

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Federal
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/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
The
Agency
believes
that
the
three
conditions
listed
above
regarding
percent
crop
treated
information
have
been
met.
With
respect
to
Condition
1,
PCT
estimates
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
EPA
uses
a
weighted
average
PCT
for
chronic
dietary
exposure
estimates.
This
weighted
average
PCT
figure
is
derived
by
averaging
State­
level
data
for
a
period
of
up
to
10
years,
and
weighting
for
the
more
robust
and
recent
data.
A
weighted
average
of
the
PCT
reasonably
represents
a
person's
dietary
exposure
over
a
lifetime,
and
is
unlikely
to
underestimate
exposure
to
an
individual
because
of
the
fact
that
pesticide
use
patterns
(
both
regionally
and
nationally)
tend
to
change
continuously
over
time,
such
that
an
individual
is
unlikely
to
be
exposed
to
more
than
the
average
PCT
over
a
lifetime.
For
acute
dietary
exposure
estimates,
EPA
uses
an
estimated
maximum
PCT.
The
exposure
estimates
resulting
from
this
approach
reasonably
represent
the
highest
levels
to
which
an
individual
could
be
exposed,
and
are
unlikely
to
underestimate
an
individual's
acute
dietary
exposure.
The
Agency
is
reasonably
certain
that
the
percentage
of
the
food
treated
is
not
likely
to
be
an
underestimation.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
diflubenzuron
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide)
and
its
metabolites,
4­
chlorophenylurea
(
CPU)
and
4­
chloroaniline
(
PCA)
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
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide)
and
its
metabolites,
4­
chlorophenylurea
(
CPU)
and
4­
chloroaniline
(
PCA).
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screeninglevel
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
diflubenzuron
they
are
further
discussed
in
the
aggregate
risk
sections.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
diflubenzuron
and
CPU
are
estimated
to
be
0.99
ppb
(
diflubenzuron)
and
8.81
ppb
(
CPU)
for
surface
water
and
0.0023
ppb
(
diflubenzuron)
and
0.065
ppb
(
CPU)
for
ground
water.
PCA
is
not
a
significant
metabolite
in
the
environment.
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).
Although
there
are
no
registered
homeowner
uses
for
diflubenzuron,
there
is
potential
for
professional
applications
to
outdoor
residential
and
recreational
areas
to
control
mosquitos,
moths,
and
other
insects.
However,
due
to
the
low
dermal
absorption
rate
(
0.05%)
and
extremely
low
dermal
and
inhalation
toxicity,
exposure
through
these
uses
is
expected
to
be
insignificant,
and
residential
postapplication
exposure
was
not
quantitatively
evaluated.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
diflubenzuron
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
diflubenzuron
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
diflubenzuron
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
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
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Federal
Register
/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
Based
on
the
developmental
and
reproductive
toxicity
studies
summarized
in
Table
1,
there
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
diflubenzuron
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Based
on
the
developmental
and
reproductive
data
available,
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
(
as
required
by
FQPA)
should
be
removed.
This
decision
was
based
on
the
following:
i.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
ii.
A
developmental
neurotoxicity
study
(
DNT)
with
diflubenzuron
is
not
required;
iii.
Food
and
drinking
water
exposure
assessments
will
not
underestimate
the
potential
exposure
for
infants
and
children;
and
iv.
There
are
currently
no
registered
or
proposed
residential
(
nonoccupational
uses
of
diflubenzuron
for
homeowners.
Although
there
are
no
registered
homeowner
uses,
there
is
potential
for
professional
applications
to
outdoor
residential
and
recreational
areas
to
control
mosquitos,
moths,
and
other
insects.
However,
the
potential
for
post­
application
residential
exposures
are
expected
to
be
limited.
Due
to
the
low
dermal
absorption
rate
(
0.5%)
of
diflubenzuron,
and
since
it
is
only
applied
to
the
tree
canopy
to
control
gypsy
moths
and
mosquitoes,
minimal
bystander
contact
is
expected.
Recently,
EPA
has
received
objections
to
a
tolerance
it
established
for
residues
of
diflubenzuron
in
or
on
pears.
The
objections
were
filed
by
the
Natural
Resources
Defense
Council
(
NRDC)
and
raised
several
issues
regarding
aggregate
exposure
estimates
and
the
additional
safety
factor
for
the
protection
of
infants
and
children.
NRDC's
objections
raise
complex
legal,
scientific,
policy,
and
factual
matters
and
EPA
has
initiated
a
public
comment
period
on
them
in
the
Federal
Register
of
June
19,
2002
(
67
FR
41628)
(
FRL
 
7167
 
7),
which
ends
on
September
17,
2002.
Although
that
proceeding
remains
ongoing,
prior
to
acting
on
this
current
tolerance
action,
EPA
reviewed
the
diflubenzuronspecific
objections
raised
by
NRDC
and
has
addressed
them
below.
NRDC
claims
datagaps
include
missing
residue
chemistry
and
toxicology
data
for
two
diflubenzuron
metabolites,
deemed
necessary
by
EPA
to
justify
an
unconditional
registration.
EPA
determined
that
the
toxicology
database
for
diflubenzuron
is
complete
for
assessment
of
increased
susceptibility
to
infants
and
children
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
.
There
are
no
data
gaps
for
the
assessment
of
the
effects
of
diflubenzuron
following
in
utero
and/
or
postnatal
exposure.
There
was
no
evidence
that
diflubenzuron
targets
the
nervous
system;
neither
clinical
signs
indicative
of
neurotoxicity
nor
neuropathology
were
seen
in
any
of
the
acute,
subchronic
or
chronic
studies.
There
are
reliable
data
that
indicate
there
are
(
residual)
concerns
for
preand
or
post­
natal
toxicity.
There
was
no
evidence
(
quantitative
or
qualitative)
of
increased
susceptibility
following
in
utero
exposure
to
rats
or
rabbits
or
to
postnatal
exposure
to
rats.
In
the
prenatal
developmental
toxicity
studies
in
rats
and
rabbits,
no
developmental
toxicity
was
seen
at
the
Limit
Dose
(
1,000
mg/
kg/
day)
and
in
the
twogeneration
reproduction
study
in
rats
toxicity
in
the
offspring
was
manifested
as
decreased
body
weight
at
approximately
4,000
mg/
kg/
day
(
4
times
the
Limit
Dose).
Based
on
the
lack
of
evidence
of
neurotoxic
potential
and
increased
susceptibility,
EPA
determined
that
a
developmental
neurotoxicity
study
in
rats
was
not
required.
The
Agency
believes
that
it
has
sufficient
data
for
the
metabolites,
PCA
and
CPU
because
the
rate
of
metabolism
of
diflubenzuron
to
PCA
or
CPU
in
plants,
ruminants,
and
the
environment
is
low
and,
thus,
exposure
to
these
metabolites
will
be
minimal.
Adequate
data
are
available
to
assess
the
cancer
risks
for
both
PCA
and
CPU.
Even
using
the
most
conservative
cancer
risk
assessment
model,
which
is
the
low
dose
linear
model,
risk
is
negligible.
EPA's
experience
is
that
a
risk
assessment
using
a
low
dose
linear
cancer
assessment
will
be
the
most
sensitive
risk
endpoint
indicating
that
additional
hazard
testing
for
these
metabolites
will
not
lead
to
a
more
protective
regulatory
decision.
NRDC
also
claims
that
by
relying
on
anticipated
residue
estimates
for
diflubenzuron
on
certain
crops
EPA
vastly
underestimates
dietary
exposure.
This
underestimation
occurs,
according
to
NRDC
because
EPA
does
not
take
into
account
that
a
significant
number
of
consumers
buy
produce
at
farm
stands.
Even
assuming
that
exposure
as
a
result
of
purchases
at
farm
stands
constitute
more
than
a
negligible
exposure,
NRDC's
claims
here
are
inaccurate.
Anticipated
residues
are
based
on
data
from
crop
field
trials
using
application
rates
and
procedures
that
will
produce
maximum
residues
under
the
currentlyapproved
pesticide
label
at
the
time
of
harvest.
As
such,
they
are
likely
to
overstate
not
understate
residue
levels
of
crops
at
farm
stands.
Finally,
NRDC
asserts
that
EPA
has
underestimated
aggregate
exposure
to
diflubenzuron
because
EPA
concluded
that
application
of
diflubenzuron
to
tree
canopies
would
result
in
negligible
residential
exposure
to
diflubenzuron.
After
review,
however,
EPA
reaffirms
that
these
potential
exposures
are
expected
to
be
limited.
The
label
states
that
``
applications
should
be
made
during
periods
of
minimal
use.''
and
requires
users
to
``
Notify
persons
using
recreational
facilities
or
living
in
the
area
to
be
sprayed
before
application.''
Diflubenzuron
is
only
applied
by
commercial
applicators
to
the
tree
canopy
for
control
of
gypsy
moths
and
mosquitoes.
Generally
applied
by
helicopter,
these
sprays
are
not
aerosols
or
ultra
low
volume
sprays
designed
as
space
sprays,
but
are
rather
directed
to
the
tree
canopy
and
designed
to
impinge
on
the
tree
tops
where
they
would
be
effective
in
pest
control.
The
sprays
designed
for
application
to
tree
canopies
utilize
much
larger
droplet
sizes
which
are
essentially
nonrespirable;
therefore,
minimal
inhalation
exposure
to
bystanders
is
expected.
Additionally,
due
to
a
low
dermal
absorption
rate
(
0.5%),
the
potential
for
dermal
exposure
to
bystanders
is
expected
to
be
minimal.
In
any
event,
EPA
would
note
that
the
results
of
the
chronic
dietary
analysis
indicated
that
the
estimated
chronic
dietary
risk
associated
with
the
proposed
use
of
diflubenzuron
was
well
below
the
Agency's
level
of
concern
for
the
general
U.
S.
population.
In
fact,
the
highest
exposed
population
subgroup
(
all
infants
<
1
years
of
age)
is
5.5%
of
the
PAD.
The
PAD
is
the
Population
Adjusted
Dose,
which
is
the
Reference
Dose
(
RfD)
divided
by
the
FQPA
Safety
Factor.
The
Agency's
level
of
concern
is
for
exposures
in
excess
of
100%
of
the
PAD.
An
acute
dietary
exposure
risk
assessment
was
not
conducted
since
no
hazard
was
identified
for
any
population,
including
infants
and
children,
following
a
single
exposure
to
diflubenzuron
(
i.
e.,
no
hazard
was
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/
Rules
and
Regulations
identified,
therefore,
quantification
of
risk
is
not
required).

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2L/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
There
is
no
risk
from
acute
dietary
exposure
(
1
day)
to
diflubenzuron
as
there
is
no
toxic
endpoint
identified.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
diflubenzuron
and
its
metabolite
CPU
from
food
will
utilize
1%
of
the
cPAD
for
the
U.
S.
population,
5.5%
of
the
cPAD
for
infants
and
1.2%
of
the
cPAD
for
children
1
 
6
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
diflubenzuron
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
diflubenzuron
and
its
metabolite
CPU
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
5
below.
For
the
chronic
analysis,
ARs
and
%
CT
information
for
some
commodities
were
used
(
Tier
3).
The
results
of
the
chronic
analysis
for
diflubenzuron
indicate
that
the
estimated
chronic
dietary
risk
associated
with
the
proposed
use
of
diflubenzuron
is
below
HED's
level
of
concern.
The
EECs
generated
by
EFED
are
less
than
HED's
DWLOCs.
Thus,
chronic
non­
cancer
aggregate
risk
estimates
are
below
HED's
level
of
concern.
Table
5
summarizes
the
chronic
non­
cancer
aggregate
exposure
to
diflubenzuron
residues.

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
DIFLUBENZURON
AND
CPU
Scenario/
Population
Subgroup
cPAD,
mg/
kg/
day
%
cPAD
(
Food)
Ground
Water
EEC,
ppb
Surface
Water
EEC1,
ppb
Chronic
DWLOC2,
ppb
U.
S.
population
0.02
<
1.0
0.067
9.8
700
All
infants
(<
1
year
old)
0.02
5.5
0.067
9.8
190
Children
(
1
 
6
years
old)
0.02
1.2
0.067
9.8
200
Children
(
7
 
1
2
years
old)
0.02
1.0
0.067
9.8
200
Females
(
13
 
50
years
old)
0.02
<
1.0
0.067
9.8
700
Males
(
13
 
19
years
old)
0.02
<
1.0
0.067
9.8
700
Males
(
20+
years
old)
0.02
<
1.0
0.067
9.8
700
Seniors
(
55+
years
old)
0.02
<
1.0
0.067
9.8
700
1
EECs
for
diflubenzuron
+
CPU
resulting
from
the
worst­
case
water
exposure
estimate
scenario
(
peppers).
2
The
chronic
DWLOCs
were
calculated
as
follows:
DWLOC
(
µ
g/
L)
=
maximumwater
exposure
(
mg/
kg/
day)/
consumption
(
L/
day)
x
0.001
mg/
µ
g
x
body
weight(
kg)

3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Diflubenzuron
is
not
registered
for
use
on
any
sites
that
would
result
in
substantial
residential
exposure.
Therefore,
a
short­
term
aggregate
risk
assessment
was
not
performed.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Based
on
the
use
pattern,
intermediate­
term
exposure
to
diflubenzuron
would
not
be
expected.
Therefore,
an
intermediate­
term
aggregate
risk
assessment
was
not
performed.
5.
Aggregate
cancer
risk
for
U.
S.
population.
As
discussed
in
the
Exposure
Assessment
in
Unit.
III.
C.
of
this
document,
CPU
is
the
only
metabolite
of
concern
for
aggregate
cancer
risk
that
is
likely
to
be
found
in
drinking
water.
For
the
chronic
analysis,
ARs
and
%
CT
information
for
some
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/
Rules
and
Regulations
commodities
were
used
(
Tier
3).
The
results
of
the
cancer
analysis
indicate
that
the
estimated
cancer
dietary
risk
from
CPU
associated
with
the
proposed
use
of
diflubenzuron
is
below
the
Agency's
level
of
concern.
Based
on
a
negligible
risk
in
the
range
of
1­
3
x
10­
6,
the
DWLOCs
were
calculated
to
be
in
the
range
of
2.2­
6.8
µ
g/
L.
The
EECs
for
surface
water
(
8.81
µ
g/
L)
slightly
exceed
the
DWLOCs.
Since
PCA
is
not
found
in
drinking
water,
the
aggregate
cancer
risk
for
PCA
is
the
risk
calculated
for
food
only
(
4.7
x
10­
7).
The
Agency
used
a
screening
level
model
designed
to
estimate
pesticide
concentrations
in
surface
water.
Although
the
cancer
DWLOC
is
exceeded
by
the
EEC
for
CPU
on
peppers,
a
number
of
factors
lead
the
Agency
to
believe
that
the
actual
lifetime
exposure
through
drinking
water
from
the
metabolite
CPU
will
be
less
than
the
cancer
DWLOC.
An
explanation
is
provided
below:
i.
The
dietary
risk
for
CPU
is
minimal
from
mushrooms,
milk,
and
liver.
Therefore,
the
dietary
risk
from
CPU
occurs
mostly
from
exposure
that
results
from
its
formation
in
the
environment
and
leaching
into
the
surface
water
as
a
result
of
field
application.
ii.
The
PRZM/
EXAMS
model
does
not
consider
the
impact
of
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
of
drinking
water
and
removal
of
pesticides
from
source
water.
iii.
In
the
absence
of
reliable
monitoring
data,
a
default
percent
crop
area
(
PCA)
factor
is
applied
to
the
PRZM/
EXAMS
modeling.
Although
the
DWLOC
is
exceeded
for
peppers,
the
PCA
factor
of
87%
that
was
used
in
the
assessment
is
likely
to
be
higher
than
the
actual
factor
that
would
be
appropriate
for
peppers
in
an
agricultural
watershed.
iv.
To
address
the
uncertainties
caused
by
the
absence
of
reliable
monitoring
data,
the
applicant
has
agreed
to
conduct
edge­
of­
field
runoff
studies
for
peppers
to
monitor
the
actual
concentrations
of
CPU
in
surface
water.
These
data,
albeit
still
relevant
solely
for
estimation
of
residues
in
raw
water
and
thus
still
likely
to
overestimate
residues
in
actual
drinking
water,
are
likely
to
lower
the
upper
bound
risk
estimate
considerably.
6.
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
diflubenzuron
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
methods
are
available
for
the
analysis
of
diflubenzuron,
PCA,
and
CPU
in
crops.
Three
enforcement
methods
for
diflubenzuron
are
published
in
the
Pesticide
Analytical
Method
Volume
II
(
PAM
II)
as
Methods
I,
II,
and
III.
Method
II
is
a
GC/
ECD
method
that
can
separately
determine
residues
of
diflubenzuron,
CPU,
and
PCA
in
eggs,
milk,
and
livestock
tissues.
All
three
methods
have
undergone
a
successful
petition
method
validation
(
PMV)
and
are
acceptable
for
enforcement
purposes.
Individual
analyte
methods
for
CPU
(
limit
of
quantitation
(
LOQ)
of
0.001
ppm)
and
PCA
(
LOQ
of
0.005
ppm)
have
been
successfully
validated
by
the
Analytical
Chemistry
Branch
(
ACB).
Multiresidue
Method
(
MRM).
The
FDA
PESTDATA
database
dated
1/
94
(
PAM
Vol.
I,
Appendix
II)
contains
no
information
on
diflubenzuron
recovery
using
MRM
PAM,
Vol.
I
Sections
302,
303,
and
304.
However,
the
registrant
has
submitted
Multiresidue
testing
data
that
the
Agency
has
forwarded
to
the
FDA.
Also,
the
results
of
MRM
testing
of
PCA
and
CPU
have
been
submitted
and
forwarded
to
FDA.
Neither
PCA
nor
CPU
were
adequately
recovered
by
any
protocols.

B.
International
Residue
Limits
There
are
no
Codex
proposals,
Canadian,
or
Mexican
limits
for
residues
of
diflubenzuron
on
rice.
A
compatibility
issue
is
not
relevant
to
the
proposed
tolerances.

C.
Conditions
Environmental
fate.
Edge
of
field
monitoring
study
for
peppers.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
of
the
insecticide
diflubenzuron
(
N­[[
4­
chlorophenyl)
amino]­
carbonyl]­
2,6­
difluorobenzamide)
and
its
metabolites,
4­
chlorophenylurea
(
CPU)
and
4­
chloroaniline
(
PCA),
in
or
on
the
following
raw
agricultural
commodities:
Grass,
forage,
fodder,
and
hay
group
at
6.0
ppm;
pepper
at
1.0
ppm;
stone
fruit
group
(
except
cherries)
at
0.07
ppm;
tree
nut
group
at
0.06
ppm;
almond
hulls
at
6.0
ppm;
pistachio
at
0.06
ppm;
cattle,
meat
byproducts
at
0.15
ppm;
goat,
meat
byproducts
at
0.15
ppm;
hog,
meat
byproducts
at
0.15
ppm;
horse,
meat
byproducts
at
0.15
ppm;
sheep,
meat
byproducts
at
0.15
ppm.
The
tolerances
for
pasture
grass
and
walnut
will
be
deleted,
concomitant
with
the
establishment
of
the
tree
nut
group
and
grass,
forage,
fodder,
and
hay
group
tolerances.

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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
control
number
OPP
 
2002
 
0224
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
18,
2002.
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
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Rules
and
Regulations
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
control
number
OPP
 
2002
 
0224,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
tolerance
under
FFDCA
section
408(
d)
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
FFDCA
section
408(
d),
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
FFDCA
section
408(
n)(
4).
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
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Thursday,
September
19,
2002
/
Rules
and
Regulations
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
Submission
to
Congress
and
the
Comptroller
General
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:
September
11,
2002.
Peter
Caulkins,
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
374.
2.
Section
180.377
is
amended
as
follows:
i.
By
removing
the
entries
for
``
Cattle,
meat
byproducts'';
``
Goat,
meat
byproducts'';
``
Hog,
meat
byproducts'';
``
Horse,
meat
byproducts'';
``
Sheep,
meat
byproducts'';
and
``
Walnut''
from
the
table
in
paragraph
(
a)(
1);
ii.
By
alphabetically
adding
the
entries
for
``
Almond,
hulls'';
``
Cattle,
meat
byproducts'';
``
Fruit,
stone,
group
12,
except
cherries'';
``
Goat,
meat
byproducts'';
``
Grass,
fodder,
forage,
and
hay,
group
17'';
``
Hog,
meat
byproducts'';
``
Horse,
meat
byproducts'';
``
Nut,
tree,
group
14'';
``
Pepper'';
``
Pistachio'';
and
``
Sheep,
meat
byproducts''
to
the
table
in
paragraph
(
a)(
2);
and
iii.
By
removing
the
text
from
paragraph
(
c)
and
reserving
paragraph
(
c)
with
the
heading.
The
additions
and
revisions
read
as
follows:
§
180.377
Diflubenzuron;
tolerances
for
residues.
(
a)
General.
(
1)
*
*
*
(
2)
*
*
*

Commodity
Parts
per
million
Almond
,
hulls
6.0
Cattle,
meat
byproducts
0.15
Fruit,
stone,
group
12,
except
cherries
0.07
Goat,
meat
byproducts
0.15
Grass,
forage,
fodder,
and
hay,
group
17
6.0
Hog,
meat
byproducts
0.15
Horse,
meat
byproducts
0.15
Nut,
tree,
group
14
0.06
*
*
*
*
*
Pepper
1.0
Pistachio
0.06
*
*
*
*
*
Sheep,
meat
byproducts
0.15
*
*
*
*
*

[
FR
Doc.
02
 
23818
Filed
9
 
18
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
300
[
FRL
 
7377
 
4]

National
Oil
and
Hazardous
Substance
Pollution
Contingency
Plan;
National
Priorities
List
AGENCY:
Environmental
Protection
Agency.
ACTION:
Direct
final
notice
of
deletion
of
the
Basic
Microelectronics,
Incorporated
(
BMI)­
Textron
Superfund
Site
from
the
National
Priorities
List.

SUMMARY:
The
Environmental
Protection
Agency
(
EPA)
Region
4
is
publishing
a
direct
final
notice
of
deletion
of
the
BMI­
Textron
Superfund
Site
(
Site),
located
in
Lake
Park,
West
Palm
Beach
County,
Florida,
from
the
National
Priorities
List
(
NPL).
The
NPL,
promulgated
pursuant
to
section
105
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
(
CERCLA)
of
1980,
as
amended,
is
appendix
B
of
40
CFR
part
300,
which
is
the
National
Oil
and
Hazardous
Substances
Pollution
Contingency
Plan
(
NCP).
This
direct
final
deletion
is
being
published
by
EPA
with
the
concurrence
of
the
State
of
Florida,
through
the
Florida
Department
of
Environmental
Protection
(
FDEP
(
formerly
FDER))
because
EPA
has
determined
all
appropriate
response
actions
under
CERCLA
have
been
completed
and,
therefore,
further
remedial
action
pursuant
to
CERCLA
is
not
appropriate.
DATES:
This
direct
final
deletion
will
be
effective
November
18,
2002,
unless
EPA
receives
adverse
comments
by
October
21,
2002.
If
adverse
comments
are
received,
EPA
will
publish
a
timely
withdrawal
of
the
direct
final
deletion
in
the
Federal
Register
informing
the
public
the
deletion
will
not
take
effect.
ADDRESSES:
Comments
may
be
mailed
to:
Jan
Martin,
Remedial
Project
Manager
(
RPM),
U.
S.
EPA,
Region
4
(
4WD
 
SSMB),
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30303,
(
404)
562
 
8593,
martin.
jan@
epa.
gov.
Information
Repositories:
Comprehensive
information
about
the
Site
is
available
for
viewing
and
copying
at
the
Site
information
repositories
located
at:
U.
S.
EPA
Record
Center,
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30365,
Phone:
(
404)
562
 
8190,
Hours:
8
a.
m.
to
5
p.
m.,
Monday
through
Friday
(
By
Appointment
Only).
Lake
Park
Library,
529
Park
Avenue,
Lake
Park,
Florida
30403,
Phone:
(
561)
881
 
3330,
Hours:
9
a.
m.
to
8:
30
p.
m.,
Monday
and
Tuesday,
9
a.
m.
to
5:
30
p.
m.,
Wednesday
through
Friday,
9:
30
a.
m.
to
2
p.
m.,
Saturday.

FOR
FURTHER
INFORMATION
CONTACT:
Jan
Martin,
Remedial
Project
Manager
(
RPM),
U.
S.
EPA,
Region
4
(
4WD
 
SSMB),
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30303,
(
404)
562
 
8593,
martin.
jan@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Table
of
Contents
I.
Introduction
II.
NPL
Deletion
Criteria
III.
Deletion
Procedures
IV.
Basis
for
Site
Deletion
V.
Deletion
Action
I.
Introduction
EPA
Region
4
is
publishing
this
direct
final
notice
of
deletion
of
the
BMITextron
Superfund
Site
(
Site)
from
the
NPL.
The
EPA
identifies
sites
that
appear
to
present
a
significant
risk
to
public
health
or
the
environment
and
maintains
the
NPL
as
the
list
of
those
sites.
As
described
in
the
§
300.425(
e)(
3)
of
the
NCP,
sites
deleted
from
the
NPL
remain
eligible
for
remedial
actions
if
conditions
at
a
deleted
site
warrant
such
action.
Because
EPA
considers
this
action
to
be
noncontroversial
and
routine,
EPA
is
taking
it
without
prior
publication
of
a
notice
of
intent
to
delete.
This
action
will
be
effective
November
18,
2002,
unless
EPA
receives
adverse
comments
by
October
21,
2002,
on
this
document.

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