Document ID: EPA-HQ-OPP-2002-0253-0001
Agency: epa
Document Type: Rule
Title: Diflubenzuron; Pesticide Tolerances for Emergency Exemption.
Posted Date: 2002-09-20T04:00Z

59177
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
commodities
to
the
table
in
paragraph
(a)
to
read
as
follows:

§
180.507
Azoxystrobin;
tolerances
for
residues.

(a)
General.
***

Commodity
Parts
per
million
*****
Caneberry
subgroup
.................
5.0
Cranberry
..............
0.50
*****
Hops,
dried
cones
20.0
*****
Pea
and
bean,
dried
shelled,
except
soybean,
subgroup,
except
cowpea,
and
field
pea
............
0.50
Pea
and
bean,
succulent
shelled,
subgroup
except
cowpea
..............
0.50
Pistachio
...............
0.50
*****
Vegetable,
legume,
edible
podded,
subgroup,
except
soybean
.............
3.0
*****

*
*
*
*
*

[FR
Doc.
02–
23808
Filed
9–
19–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0253;
FRL–
7273–
7]

Diflubenzuron;
Pesticide
Tolerances
for
Emergency
Exemption
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
time­
limited
tolerances
for
residues
of
diflubenzuron
in
or
on
forage
and
hay
of
alfalfa.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
authorizing
use
of
the
pesticide
on
alfalfa.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
diflubenzuron
in
these
feed
commodities.
The
tolerances
will
expire
and
are
revoked
on
June
30,
2004.

DATES:
This
regulation
is
effective
September
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP–
2002–
0253,
must
be
received
on
or
before
November
19,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP–
2002–
0253
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Andrea
Conrath,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
308–
9356;
e­
mail
address:
conrath.
andrea@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
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–
0253.
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
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,
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
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408
(l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
is
establishing
tolerances
for
residues
of
the
insecticide
diflubenzuron,
[N­[[(
4­
chlorophenyl)
amino]
carbonyl]­
2,6­
difluorobenzamide],
in
or
on
alfalfa,
forage
and
alfalfa,
hay
at
6.0
parts
per
million
(ppm).
These
tolerances
will
expire
and
are
revoked
on
June
30,
2004.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerances
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
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/
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No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.
''
Section
408(
b)(
2)(
A)(
ii)
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.
.
.
.''
Section
18
of
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.
''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
(FQPA).
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.
Recently,
EPA
has
received
objections
to
a
tolerance
it
established
for
diflubenzuron
on
a
different
food
commodity.
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.
Although
these
objections
concern
separate
rulemaking
proceedings
under
the
FFDCA,
EPA
has
considered
whether
it
is
appropriate
to
establish
the
emergency
exemption
tolerances
for
diflubenzuron
while
the
objections
are
still
pending.
Factors
taken
into
account
by
EPA
included
how
close
the
Agency
is
to
concluding
the
proceedings
on
the
objections,
the
nature
of
the
current
action,
whether
NRDC's
objections
raised
frivolous
issues,
and
extent
to
which
the
issues
raised
by
NRDC
had
already
been
considered
by
EPA.
Although
NRDC's
objections
are
not
frivolous,
the
other
factors
all
support
establishing
these
tolerances
at
this
time.
First,
the
objections
proceeding
is
not
near
to
conclusion.
NRDC's
objections
raise
complex
legal,
scientific,
policy,
and
factual
matters
and
on
August
16,
2002,
EPA
extended
(for
an
additional
30
days)
the
public
comment
period
on
these
objections,
first
initiated
for
60
days
in
the
Federal
Register
of
June
19,
2002
(67
FR
41628)
(FRL–
7167–
7)
and
on
August
16,
2002
(67
FR
53505)
(FRL–
7193–
6).
Second,
the
nature
of
the
current
action
is
extremely
time
sensitive
as
it
addresses
an
emergency
situation.
Third,
the
issues
raised
by
NRDC
are
not
new
matters
but
questions
that
have
been
the
subject
of
considerable
study
by
EPA
and
comment
by
stakeholders.
Accordingly,
EPA
is
proceeding
with
establishing
these
tolerances
for
diflubenzuron.

III.
Emergency
Exemption
for
Diflubenzuron
on
Alfalfa
and
FFDCA
Tolerances
The
Applicant
(Utah
Department
of
Agriculture
and
Food)
states
that
outbreaks
of
the
Mormon
cricket
and
various
grasshopper
species
have
increased
in
Utah's
alfalfa
fields
this
season,
due
in
large
part
to
the
drought
being
experienced.
Because
of
the
drought
conditions,
there
is
no
feed
on
public
lands
for
the
insects,
and
the
insects
are
moving
faster
to
the
private
farmland
in
Utah.
Historically,
grasshoppers
and
crickets
have
posed
a
threat
to
all
crops,
even
plaguing
pioneers
150
years
ago.
The
Mormon
cricket
can
be
economically
devastating,
and
destroys
sagebrush,
alfalfa,
small
grains,
seed,
grasses,
and
vegetable
crops.
Grasshoppers
have
also
been
increasing
in
localized
areas
during
the
past
four
years,
and
in
2001,
the
Applicant
states
that
crop
production
was
hit
hard
from
the
heavily
infested
spots
from
both
the
grasshoppers
and
the
Mormon
cricket.
Many
fields
left
untreated
in
2001
experienced
a
100%
reduction
in
yield,
and
the
Applicant
states
that
the
infestation
levels
for
2002
are
even
greater
than
estimated.
While
there
are
several
chemical
controls
registered
for
use
in
Utah
for
crickets
and
grasshoppers,
regulations
prohibiting
more
than
one
application
combined
with
prohibitive
costs
make
multiple
applications
an
ineffective
solution.
The
Applicant
states
that
diflubenzuron
is
the
only
pesticide
that
has
been
proven
effective
for
full­
season
control
of
grasshopper
and
cricket
outbreaks.
Diflubenzuron
has
a
longer
period
of
residual
activity
than
the
registered
alternatives,
which
allows
for
control
of
delayed
hatching
nymphs,
later
hatching
grasshopper
species,
and
secondary
infestations,
which
precludes
the
need
for
additional
applications.
The
Applicant
asserts
that
the
registered
alternative
have
very
short
residual
activity
and/
or
are
prohibitively
expensive
for
use
in
this
situation.
Significant
economic
losses
were
expected
to
occur
this
year
for
alfalfa
producers,
without
the
use
of
diflubenzuron
to
control
these
pests.
EPA
has
authorized
under
section
18
of
FIFRA
the
use
of
diflubenzuron
on
alfalfa
for
control
of
the
Mormon
cricket
and
various
grasshopper
species
in
Utah.
After
having
reviewed
the
submission,
EPA
concurs
that
emergency
conditions
exist
for
this
State.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
diflubenzuron
in
or
on
alfalfa
forage
and
hay.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
tolerances
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
section
18
of
FIFRA.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non­
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
establishing
these
tolerances
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6).
Although
these
tolerances
will
expire
and
are
revoked
on
June
30,
2004,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
not
in
excess
of
the
amounts
specified
in
the
tolerances
remaining
in
or
on
alfalfa
forage
and
hay
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA,
and
the
residues
do
not
exceed
the
level
that
was
authorized
by
these
tolerances
at
the
time
of
that
application.
EPA
will
take
action
to
revoke
these
tolerances
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
this
pesticide
indicate
that
the
residues
are
not
safe.
Because
these
tolerances
are
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
diflubenzuron
meets
EPA's
registration
requirements
for
use
on
alfalfa
or
whether
permanent
tolerances
for
this
use
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
these
tolerances
serve
as
a
basis
for
registration
of
diflubenzuron
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Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
by
a
State
for
special
local
needs
under
section
24(
c)
of
FIFRA.
Nor
do
these
tolerances
serve
as
the
basis
for
any
State
other
than
Utah
to
use
this
pesticide
on
this
crop
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemption
for
diflubenzuron,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.

IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
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)
.
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
diflubenzuron
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2),
for
time­
limited
tolerances
for
residues
of
diflubenzuron
in
or
on
alfalfa
hay
and
forage
at
6.0
ppm.
No
alfalfa
residue
data
were
submitted
for
this
request.
The
proposed
use
rate
of
diflubenzuron
for
alfalfa
is
the
same
as
that
registered
for
use
on
grass.
Therefore,
the
data
from
grass
was
translated
to
alfalfa
for
this
section
18
use.
The
established
tolerances
for
meat
and
milk
commodities
are
adequate
to
cover
any
residues
which
may
result
from
this
section
18
use.
Based
upon
previous
feeding
studies,
the
secondary
residues
in
meat
and
milk
will
not
exceed
the
established
tolerances
as
a
result
of
this
section
18
use.
Residues
of
diflubenzuron
in/
on
alfalfa
are
not
expected
to
increase
dietary
exposure.
Since
alfalfa
is
not
consumed
by
humans,
any
exposure
to
residues
of
diflubenzuron
from
this
emergency
exemption
use
will
result
from
the
consumption
of
meat
or
milk.
The
use
of
diflubenzuron
in
alfalfa
is
not
expected
to
result
in
exceedances
of
the
tolerances
that
already
exist
for
meat
and
milk.
Therefore,
establishing
the
alfalfa
tolerances
will
not
increase
the
most
recent
estimated
aggregate
risks
resulting
from
the
use
of
diflubenzuron,
as
discussed
in
the
Federal
Register
for
February
15,
2002
(67
FR
7085)
(FRL–
6821–
7)
final
rule
establishing
a
tolerance
for
residues
of
diflubenzuron
in/
on
pears,
because
in
that
prior
action,
risk
was
estimated
assuming
all
meat
and
milk
commodities
contained
tolerance
level
residues.
Refer
to
the
February
15,
2002
Federal
Register
document
for
a
detailed
discussion
of
the
aggregate
risk
assessments
and
determination
of
safety.
EPA
relies
upon
that
risk
assessment
and
the
findings
made
in
the
Federal
Register
document
in
support
of
this
action.
Below
is
a
brief
summary
of
the
aggregate
risk
assessment.
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
A
summary
of
the
toxicological
dose
and
endpoints
for
diflubenzuron
for
use
in
human
risk
assessment
is
discussed
in
final
rule
mentioned
above,
published
in
the
Federal
Register
of
February
15,
2002.
EPA
assessed
risk
scenarios
for
diflubenzuron
under
chronic
exposures
only.
Acute
toxicological
endpoints
have
not
been
identified
for
diflubenzuron,
and
there
are
no
registered
or
proposed
uses
which
would
result
in
short­
and
intermediateterm
exposure;
thus
these
exposure
analyses
were
not
necessary.
Although
diflubenzuron
itself
is
not
classified
as
a
carcinogen,
two
of
its
metabolites,
PCA
(p­
chloroaniline)
and
CPU
pchlorophenylurea
are
probable
human
carcinogens
and
have
been
assigned
Q1*
s.
Since
these
degradates
are
found
in
mushrooms,
milk,
and
liver,
as
a
result
of
diflubenzuron
use,
EPA
has
concluded
that
the
residues
of
concern
are
diflubenzuron
and
its
metabolites
PCA
and
CPU.
The
Dietary
Exposure
Evaluation
Model
(DEEM
TM
)
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:
Anticipated
residue
information
based
on
field
trial
data,
and
percent
of
crop
treated
(%
CT)
information
for
some
commodities
were
used
(Tier
3).
A
value
of
1%
was
used
for
%CT
values
<
1%.
Using
these
exposure
assessments,
the
EPA
concluded
that
exposure
to
diflubenzuron
from
food
will
utilize
<
1%
of
the
chronic
population
adjusted
dose
(cPAD)
for
the
US
Population,
5%
for
Infants
(
1
yr
old),
and
<
1%
for
Children
(1
to
6
years
old).
In
addition,
despite
the
potential
for
dietary
exposure
to
diflubenzuron
in
drinking
water,
after
calculating
drinking
water
levels
of
concern
(DWLOCs)
and
comparing
them
to
conservative
model
estimated
environmental
concentrations
(EECs)
of
diflubenzuron
in
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
1.

TABLE
1.—
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
DIFLUBENZURON
Population
Subgroup
cPAD
(mg/
kg)
%
cPAD
(Food)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Chronic
DWLOC
(ppb)

U.
S.
Population
0.02
<
1
0.09
0.0023
700
All
Infants
(
1
yr)
0.02
5
0.09
0.0023
190
Children
(1­
6
yr)
0.02
<
1
0.09
0.0023
200
Cancer
aggregate
risk
assessments
were
not
performed
for
diflubenzuron
and
PCA,
since
diflubenzuron
is
not
a
carcinogen
and
PCA
is
not
a
significant
degradate
in
drinking
water.
The
potential
cancer
risk
from
dietary
(food
only),
exposure
to
residues
of
PCA
is
4.7
x
10
­7
,
which
is
negligible.
The
results
of
the
cancer
analysis
for
CPU
indicate
that
the
estimated
cancer
dietary
(food
only)
risk
from
CPU
3.8
x
10
­8
associated
with
the
proposed
use
of
diflubenzuron
is
below
the
Agency's
level
of
concern.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
CPU
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
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and
Regulations
does
not
expect
the
aggregate
cancer
risk
to
exceed
EPA's
level
of
concern,
as
shown
in
the
following
Table
2:

TABLE
2.—
AGGREGATE
CANCER
RISK
ASSESSMENT
FOR
EXPOSURE
TO
DIFLUBENZURON
Population
Subgroup
Residential
Exposure
Aggregate
Cancer
Risk
(food
and
residential)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Cancer
DWLOC
(ppb)

U.
S.
population
0
3.8
x
10
­8
0.23
0.065
2.2
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.

V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Calvin
Furlow,
PRRIB,
IRSD
(7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(703)
305–
5229;
e­
mail
address:
furlow.
calvin@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Codex
maximum
residue
limits
(MRLs)
established
for
diflubenzuron
on
alfalfa
forage
and
hay.
Therefore,
no
compatibility
problems
exist
for
the
proposed
tolerances.

C.
Conditions
One
application
may
be
made
using
ground
or
aerial
equipment,
at
a
rate
of
2
fl.
oz.
of
product
(0.0325
lb.
active
ingredient)
per
acre.
A
14­
day
preharvest
interval
and
a
12­
hour
re­
entry
interval
must
be
observed.

VI.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
diflubenzuron,
[N­[[(
4­
chlorophenyl)
amino]
carbonyl]­
2,6­
difluorobenzamide],
in
or
on
alfalfa
forage,
and
alfalfa
hay
at
6.0
ppm.

VII.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA
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
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
control
number
OPP–
2002–
0253
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
19,
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
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
VII.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
2.
Mail
your
copies,
identified
by
the
docket
control
number
OPP–
2002–
0253,
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
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20,
2002
/
Rules
and
Regulations
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).

VIII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
time
limited
tolerances
under
section
408
of
the
FFDCA.
The
Office
of
Management
and
Budget
(OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(UMRA)
(Public
Law
104–
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(NTTAA),
Public
Law
104–
113,
section
12(
d)
(15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
section
18
FIFRA
exemption
under
section
408
of
the
FFDCA,
such
as
the
tolerances
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(RFA)
(5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.
''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.
''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers,
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.
''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.
''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

IX.
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
by
adding
the
following
language
and
table
under
paragraph
(b)
to
read
as
follows:

§
180.377
Diflubenzuron;
tolerances
for
residues.

*
*
*
*
*
(b)
Section
18
emergency
exemptions.
Time­
limited
tolerances
are
established
for
the
residues
of
diflubenzuron
and
its
metabolites
PCA
(p­
chloroaniline)
and
CPU
(p­
chlorophenylurea),
expressed
as
the
parent
diflubenzuron,
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
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Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
EPA.
The
tolerances
are
specified
in
the
following
table,
and
will
expire
and
are
revoked
on
the
dates
specified.

Commodity
Parts
per
million
Expiration/
revocation
date
Alfalfa,
forage
...............................................................................................................................................
6.0
6/
30/
2004
Alfalfa,
hay
...................................................................................................................................................
6.0
6/
30/
2004
*
*
*
*
*

[FR
Doc.
02–
23819
Filed
9–
19–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0243;
FRL–
7200–
8]

Halosulfuron­
methyl;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
halosulfuronmethyl
methyl
5­[(
4,6­
dimethoxy­
2­
pyrimidinyl)
amino]
carbonyaminosulfonyl­
3­
chloro­
1­
methyl­
1H­
pyrazole­
4­
carboxylate
in
or
on
asparagus;
vegetables,
fruiting
(except
cucurbits),
group;
bean,
dry,
seed
and
bean,
snap,
succulent.
Gowan
Company
and
Interregional
Research
Project
Number
4
(IR–
4)
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
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0243,
must
be
received
on
or
before
November
19,
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
ID
number
OPP–
2002–
0243
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Tompkins
and
Hoyt
Jamerson,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
5687
and
(703)
308–
9368,
respectively;
e­
mail
address:
tompkins.
jim@
epa.
gov
and
jamerson.
hoyt@
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
theFederal
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0243.
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
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
June
3,
2002
(67
FR
38276)
(FRL–
7179–
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
a
pesticide
petition
(PP
1E6322)
by
Interregional
Research
Project
Number
4(
IR–
4),
681
U.
S.
Highway
1
South,
North
Brunswick,
New
Jersey
08902–
3390.
In
addition
to
the
Federal
Register
of
August
31,
2001
(66
FR
45993)
(FRL–
6796–
1),
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
FQPA
announcing
the
filing
of
pesticide
petitions
0F6169
and
1F6229)
by
Gowan
Company,
P.
O.
Box
5569;
Yuma,
AZ
85366.
These
notices
included
a
summary
of
the
petitions
prepared
by
Gowan
Company,
the
registrant.
There
were
no
comments
received
in
response
to
these
notices
of
filing.

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