Document ID: EPA-HQ-OPP-2003-0103-0001
Agency: epa
Document Type: Rule
Title: Imidacloprid; Pesticide Tolerances
Posted Date: 2003-06-13T04:00Z

35303
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
Subpart
LL
 
Oklahoma

4.
Subpart
LL
is
amended
by
adding
a
new
undesignated
center
heading
and
a
new
§
62.9180
to
read
as
follows:

Emissions
From
Existing
Small
Municipal
Waste
Combustion
Units
§
62.9180
Identification
of
sources
 
negative
declaration.

Letter
from
the
Oklahoma
Department
of
Environmental
Quality
dated
October
2,
2001,
certifying
that
there
are
no
existing
small
municipal
waste
combustion
units
subject
to
40
CFR
part
60,
subpart
BBBB,
under
its
jurisdiction
in
the
State
of
Oklahoma.

[
FR
Doc.
03
 
15007
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0103;
FRL
 
7310
 
8]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
imidacloprid
and
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
the
parent
in
or
on
acerola;
artichoke,
globe;
avocado;
banana
(
import);
canistel;
corn,
pop,
grain;
corn,
pop,
stover;
cranberry;
currant;
elderberry;
feijoa;
fruit,
stone,
group
12;
gooseberry;
huckleberry;
guava;
jaboticaba;
juneberry;
lingonberry;
longan;
lychee;
mango;
mustard,
seed;
okra;
papaya;
passionfruit;
persimmon;
pulasan;
rambutan;
salal;
sapodilla;
sapote,
black;
sapote,
mamey;
Spanish
lime;
star
apple;
starfruit;
strawberry;
vegetable,
leaves
of
root
and
tuber,
group
2;
vegetable,
legume,
group
6,
except
soybean;
vegetable,
root
and
tuber,
group
1,
except
sugar
beet;
watercress;
wax
jambu.
EPA
is
also
deleting
certain
imidacloprid
tolerances
that
are
no
longer
needed
as
result
of
this
action.
The
Interregional
Research
Project
Number
4
(
IR
 
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
June
13,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0103,
must
be
received
on
or
before
August
12,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0103.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
February
5,
2003
(
68
FR
5880)
(
FRL
 
7287
 
5)
and
March
5,
2003
(
68
FR
10464)
(
FRL
 
7291
 
1)
EPA
issued
notices
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP1E6268,
1E6254,
1E6237,
1E6225,
0E6203,
2E6403,
2E6406,
2E6409,
2E6417,
2E6421,
2E6435,
2E6414,
2E6458,
and
2E6506)
by
IR
 
4,
681
U.
S.
Highway
1
South,
North
Brunswick,
NJ
08902
 
3390
and
PP
0E6074
Bayer
CropScience,
2
T.
W.
Alexander
Drive,
P.
O.
Box
12014,
Research
Triangle
Park,
NC
27709.
Those
notices
included
summaries
of
the
petitions
prepared
by
Bayer
CropScience,
the
registrant.
One
comment
was
received
in
response
to
the
notice
of
filing
of
February
5,
2003,
from
an
individual
who
requested
that
information
about
pesticide
tolerances
be
available
in
grocery
stores
next
to
the
food
labels.
The
petitions
requested
that
40
CFR
180.472
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
imidacloprid,
1­[(
6­
chloro­
3­
pyridinyl)
methyl]­
N­
nitro­
2­
imidazolidinimine,
and
its
metabolites
containing
the
6­
chloropyridinyl
VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00039
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35304
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
moiety,
all
expressed
as
imidacloprid
in
or
on
the
raw
agricultural
commodities
as
follows:
Bushberry
subgroup
13B,
lingonberry,
juneberry
and
salal
at
3.5
parts
per
million
(
ppm)
(
PP
1E6268),
okra
at
1.0
ppm
(
PP
1E6254),
watercress
at
3.5
ppm
(
PP
1E6237),
artichoke
at
2.5
ppm
(
PP
1E6225),
cranberry
at
0.05
ppm
(
PP
0E6203),
vegetable,
legume,
except
soybean,
group
6
at
4.0
ppm
(
PP
2E6403),
avocado,
papaya,
star
apple,
black
sapote,
mango,
sapodilla,
canistel,
and
mamey
sapote
at
1.0
ppm,
and
lychee,
longan,
Spanish
lime,
rambutan,
pulasan
and
persimmon
at
3.0
ppm
(
PP
2E6406),
vegetable,
leaves
of
root
and
tuber,
group
2
at
4.0
ppm
(
PP
2E6409),
strawberry
at
0.5
ppm
(
PP
2E6417),
fruit,
stone,
group
12
at
3.0
ppm
(
PP
2E6421),
guava,
feijoa,
jaboticaba,
wax
jambu,
starfruit,
passionfruit,
and
acerola
at
1.0
ppm
(
PP
2E6435),
corn,
pop,
grain
at
0.05
ppm
and
corn,
pop,
stover
at
0.2
ppm
(
PP
2E6414),
mustard
seed
at
0.05
ppm
(
PP
2E6458),
and
vegetable,
root
and
tuber,
except
sugar
beet,
group
1,
except
sugar
beet,
at
0.4
ppm
(
PP
2E6506);
imported
banana
at
0.01
ppm
(
0E6074).
The
petition
for
imported
banana
was
subsequently
amended
to
propose
a
tolerance
at
0.02
ppm.
EPA
is
also
deleting
several
established
tolerances
in
§
180.472(
a)
and
§
180.472(
b)
that
are
no
longer
needed,
as
a
result
of
this
action.
The
tolerance
deletions
under
§
180.472(
b)
are
time­
limited
tolerances
established
under
section
18
emergency
exemptions
that
are
superceded
by
the
establishment
of
general
tolerances
for
imidacloprid
and
its
metabolites
under
§
180.472(
a).
The
revisions
to
§
180.472(
a)
are
as
follows:
1.
Delete
bean,
edible,
podded
at
1.0
ppm
and
bean,
succulent,
shelled
at
1.0
ppm.
Replaced
with
vegetable,
legume,
group
6,
except
soybean
at
4.0
ppm.
2.
Delete
dasheen,
leaves
at
3.5
ppm
and
turnip
greens
at
3.5
ppm.
Replaced
with
vegetable,
leaves
of
root
and
tuber,
group
2
at
4.0
ppm.
3.
Delete
mango
at
0.2
ppm.
Replaced
with
mango
at
1.0
ppm.
4.
Delete
potato
at
0.3
ppm
and
vegetable,
tuberous
and
corm,
subgroup
at
0.3
ppm.
Replaced
with
vegetable,
root
and
tuber,
group
1,
except
sugar
beet
at
0.4
ppm.
The
revisions
to
§
180.472(
b)
are
as
follows:
1.
Delete
the
time­
limited
tolerance
for
fruit,
stone
at
3.0
ppm.
Tolerance
for
fruit,
stone,
group
12
at
3.0
ppm
is
established
by
this
action
under
180.472(
a).
2.
Delete
the
time­
limited
tolerance
for
strawberry
at
0.1
ppm.
Tolerance
for
strawberry
at
0.5
ppm
is
established
by
this
action
under
180.472(
a).
3.
Delete
the
time­
limited
tolerance
for
turnip,
roots
at
0.3
ppm.
Tolerance
for
vegetable,
root
and
tuber,
group
1,
except
sugar
beet
at
0.4
ppm
is
established
by
this
action
under
180.472(
a).
4.
Delete
the
time­
limited
tolerance
for
turnip,
tops
at
3.5
ppm.
Tolerance
for
vegetable,
leaves
of
root
and
tuber,
group
2
at
4.0
ppm
is
established
by
this
action
under
180.472(
a).
EPA
has
received
objections
to
a
timelimited
tolerance
it
established
for
residues
of
imidacloprid
on
blueberries
in
connection
with
an
emergency
exemption
for
such
use
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
7
U.
S.
C.
136
et
seq.
published
in
the
Federal
Register
of
January
18,
2002
(
67
FR
2580)(
FRL
 
6817
 
6).
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
ended
on
October
16,
2002.
Although
that
proceeding
remains
ongoing,
prior
to
acting
on
this
current
tolerance
action,
EPA
reviewed
the
imidacloprid­
specific
objections
raised
by
NRDC
and
has
addressed
them
at
relevant
points
throughout
this
preamble.
Since
EPA
review
of
the
objections
to
the
time­
limited
tolerance
for
blueberry
is
ongoing,
EPA
is
not
establishing
the
proposed
tolerance
for
blueberry
at
this
time.
Individual
commodity
tolerances
for
the
other
members
of
the
bushberry
subgroup
(
currant,
elderberry,
gooseberry
and
huckleberry)
are
established
by
this
action.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
tolerances
for
combined
residues
of
imidacloprid
on
banana
(
import)
at
0.02
ppm;
cranberry;
mustard,
seed;
corn,
pop,
grain
at
0.05
ppm;
corn,
pop,
stover
at
0.20
ppm;
vegetable,
root
and
tuber,
group
1,
except
sugar
beet
at
0.40
ppm;
strawberry
at
0.50
ppm;
acerola;
avocado;
canistel;
feijoa;
guava;
jaboticaba;
mango;
okra;
papaya;
passionfruit;
sapodilla;
sapote,
black;
sapote,
mamey;
star
apple;
starfruit;
wax
jambu
at
1.0
ppm;
artichoke,
globe
at
2.5
ppm;
fruit,
stone,
group
12;
lychee;
longan;
Spanish
lime;
rambutan;
pulasan;
persimmon
at
3.0
ppm;
currant;
elderberry;
gooseberry;
huckleberry;
juneberry;
lingonberry;
salal;
watercress
at
3.5
ppm;
vegetable,
leaves
of
root
and
tuber,
group
2;
vegetable,
legume,
group
6,
except
soybean
at
4.0
ppm.

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
imidacloprid
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00040
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35305
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3200
21/
28­
Day
dermal
toxicity
(
rabbits)
NOAEL
=
1,000
mg/
kg/
day
(
highest
dose
tested
(
HDT))
LOAEL
=
Not
identified
870.3465
4
Week
inhalation
toxicity
(
rat)
NOAEL
=
0.191
mg/
liter/
day
(
HDT)
LOAEL
=
Not
identified
870.3700
Prenatal
developmental
toxicity
(
rats)
Maternal
NOAEL
=
10
mg/
kg/
day
LOAEL
=
30
mg/
kg/
day
based
on
decreased
body
weight
gain
and
decreased
corrected
body
weight
gain.
Developmental
NOAEL
=
30
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
a
slight
increase
in
the
incidence
of
wavy
ribs.

870.3700
Prenatal
developmental
toxicity
(
rabbits)
Maternal
NOAEL
=
24
mg/
kg/
day
LOAEL
=
72
mg/
kg/
day
based
on
maternal
deaths
and
decreased
maternal
absolute
body
weights,
body
weight
gains,
and
food
consumption.
Developmental
NOAEL
=
24
mg/
kg/
day
LOAEL
=
72
mg/
kg/
day
based
on
abortion,
total
litter
resorptions,
increased
postimplantation
loss
due
to
increased
late
resorptions,
decreased
fetal
weights,
and
very
low
incidences
of
skeletal
alterations.

870.3800
Reproduction
and
fertility
effects
(
rats)
Parental/
Systemic
NOAEL
=
16.5
mg/
kg/
day
LOAEL
=
47.3
mg/
kg/
day
based
on
decreased
premating
weight
gain
by
F0
males
and
females
and
F1
females
and
decreased
gestational
weight
gain
by
F1
females.
Reproductive
NOAEL
=
47.3
mg/
kg/
day
(
HDT)
LOAEL
=
not
identified
Offspring
NOAEL
=
16.5
mg/
kg/
day
LOAEL
=
47.3
mg/
kg/
day
based
on
decreased
pup
body
weights
in
both
litters
of
both
generations.

870.4100
Chronic
toxicity
(
dogs)
NOAEL
=
72
mg/
kg/
day
(
HDT)
LOAEL
=
Not
identified
870.4200
Carcinogenicity
(
mice)
NOAEL
=
Males:
208
mg/
kg/
day;
Females:
274
mg/
kg/
day
LOAEL
=
Males:
414
mg/
kg/
day;
Females:
424
mg/
kg/
day
based
on
decreased
body
weights,
food
consumption
and
water
intake.
No
evidence
of
carcinogenicity.

870.4300
Combined
Chronic/
Carcinogenicity
(
rats)
NOAEL
=
Males:
5.7
mg/
kg/
day;
Females:
7.6
mg/
kg/
day
LOAEL
=
Males:
16.9
mg/
kg/
day;
Females:
24.9
mg/
kg/
day
based
on
thyroid
toxicity
(
increased
incidence
of
mineralized
particles
in
thyroid
colloid)
in
males.
No
evidence
of
carcinogenicity.

870.5100
Gene
Mutation
Negative
in
a
battery
of
test.
870.5300
870.5375
Chromosome
aberrations
Negative
in
battery
of
tests,
except
at
cytoxic
doses
in
an
in
vitro
mammalian
chromosome
aberration
test
and
an
in
vitro
sister
chromatid
exchange
test.
870.5380
870.5385
870.5395
870.5900
870.5550
Other
genotoxic
effects
Negative
in
a
battery
of
tests
870.5575
870.6200
Acute
neurotoxicity
screening
battery
rat
NOAEL
=
not
identified.
LOAEL
=
42
mg/
kg
based
on
decreased
motor
and
locomotor
activities
observed
in
females.

870.6200
Subchronic
neurotoxicity
screening
battery
rat
NOAEL
=
9.3
mg/
kg/
day.
LOAEL
=
63.3
mg/
kg/
day
based
on
decreased
body
weight
gain.

870.6300
Developmental
neurotoxicity
(
rat)
Maternal
NOAEL
=
20
mg/
kg/
day.
LOAEL
=
55
mg/
kg/
day
based
on
decreased
food
consumption
and
body
weight
gain
during
lactation.
Offspring
NOAEL
=
20
mg/
kg/
day.
LOAEL
=
55
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain,
decreased
motor
activity
and
decreased
caudate/
putamen
width
in
females.

VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00041
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35306
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.7485
Metabolism
and
pharmacokinetics
rat
Methylene­
labeled
imidacloprid
was
rapidly
absorbed.
There
were
no
biologically
significant
differences
between
sexes,
dose
levels,
or
route
of
administration.
Urinary
excretion
was
the
major
route
of
elimination,
with
a
lesser
amount
eliminated
in
feces.
Total
tissue
burden
after
48
hours
accounted
for
only
approximately
0.5%
of
the
recovered
radioactivity,
with
major
sites
of
accumulation
being
the
liver,
kidney
lung,
skin,
and
plasma
and
minor
sites
being
the
brain
and
testes.
There
were
two
major
evident
routes
of
biotransformation.
The
first
included
an
oxidative
cleavage
of
the
parent
compound
to
give
6­
CNA
and
its
glycine
conjugate.
Dechlorination
of
this
metabolite
formed
the
6­
hydroxynicotinic
acid
and
its
mercapturic
acid
derivative.
The
second
included
the
hydroxylation
of
imidazolidine
followed
by
elimination
of
water
of
the
parent
compound
to
give
NTN
35884.
In
a
comparison
between
[
Methylene­
14C]
Imidacloprid
and
[
Imidazolidine­
4,5­
14C]
Imidacloprid,
the
rates
of
excretion
were
similar;
however,
the
renal
portion
was
higher
with
the
imidazolidine­
labeled
test
material.
The
imidazolidine­
labeled
test
material
also
demonstrated
higher
accumulation
in
the
tissues,
with
the
major
sites
of
accumulation
being
the
liver,
kidney,
lung,
and
skin,
and
the
minor
sites
being
brain
and
muscle.

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
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.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factors
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
imidacloprid
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
IMIDACLOPRID
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
*
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
all
populations
LOAEL
=
42
mg/
kg/
day
UF
=
300
Acute
RfD
=
0.14
mg/
kg
FQPA
SF
=
1X
aPAD
=
aRfD/
FQPA
SF
=
0.14
mg/
kg
Acute
neurotoxicity
­
rat
LOAEL
=
42
mg/
kg,
based
upon
the
decrease
in
motor
and
locomotor
activities
observed
in
females.

Chronic
Dietary
all
populations
NOAEL=
5.7
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.057
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
cRfD/
FQPA
SF
=
0.057
mg/
kg/
day
Combined
chronic
tox/
carcinogenicity
­
rat
LOAEL
=
16.9
mg/
kg/
day,
based
upon
increased
incidence
of
mineralized
particles
in
thyroid
colloid
in
males.

Short­
Term
Oral
(
1
 
30
days)
oral
study
NOAEL=
10
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
­
rat
Maternal
LOAEL
=
30
mg/
kg/
day,
based
upon
decreased
body
weight
gain
and
corrected
body
weight
gain.

VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00042
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35307
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
IMIDACLOPRID
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
*
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Intermediate­
Term
Oral
(
1
 
6
months)
oral
study
NOAEL=
9.3
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Subchronic
neurotoxicity
­
rat
LOAEL
=
63.3
mg/
kg/
day,
based
upon
decreased
body
weight
gain.

Short­
Term
Dermal
(
1
 
30
days)
oral
study
NOAEL=
10
mg/
kg/
day
(
dermal
absorption
rate
=
7.2%)
2
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
­
rat
Maternal
LOAEL
=
30
mg/
kg/
day,
based
upon
decreased
body
weight
gain
and
corrected
body
weight
gain.

Intermediate­
Term
Dermal
(
1
 
6
months)
oral
study
NOAEL=
9.3
mg/
kg/
day
(
dermal
absorption
rate
=
7.2%)
2
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Subchronic
neurotoxicity
­
rat
LOAEL
=
63.3
mg/
kg/
day,
based
upon
decreased
body
weight
gain.

Long­
Term
Dermal
(>
6
months)
oral
study
NOAEL=
5.7
mg/
kg/
day
(
dermal
absorption
rate
=
7.2%)
2
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
Combined
chronic
tox/
carcinogenicity
­
rat
LOAEL
=
16.9
mg/
kg/
day,
based
upon
increased
incidence
of
mineralized
particles
in
thyroid
colloid
in
males.

Short­
Term
Inhalation
(
1
 
30
days)
oral
study
NOAEL=
10
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
­
rat
Maternal
LOAEL
=
30
mg/
kg/
day,
based
upon
decreased
body
weight
gain
and
corrected
body
weight
gain.

Intermediate­
Term
Inhalation
(
1
 
6
months)
oral
study
NOAEL=
9.3
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Subchronic
neurotoxicity
­
rat
LOAEL
=
63.3
mg/
kg/
day,
based
upon
decreased
body
weight
gain.

Long­
Term
Inhalation
(>
6
months)
oral
study
NOAEL=
5.7
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Combined
chronic
tox/
carcinogenicity
­
rat
LOAEL
=
16.9
mg/
kg/
day,
based
upon
increased
incidence
of
mineralized
particles
in
thyroid
colloid
in
males.

Cancer
(
oral,
dermal,
inhalation)
no
evidence
of
carcinogenicity
for
humans
Not
applicable
No
evidence
of
carcinogenicity
in
rats
and
mice.

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

In
its
objections
to
a
separate
imidacloprid
tolerance
action,
NRDC
claims
that
EPA
erred
by
regulating
on
the
basis
of
a
LOAEL
for
acute
and
chronic
toxicity.
As
can
be
seen
from
the
above
table,
NRDC
is
mistaken
with
regard
to
use
of
a
LOAEL
for
estimating
the
RfD
for
chronic
risk.
The
acute
toxicity
endpoint
was
based
upon
a
LOAEL
of
42
mg/
kg/
day
from
an
acute
neurotoxicity
study
in
rats.
This
value
was
adjusted
with
a
safety
factor
of
3X
to
approximate
the
value
of
a
NOAEL.
EPA
has
high
confidence
that
this
value
of
3x
is
sufficient
for
several
reasons.
The
effect
seen
at
the
LOAEL
in
the
acute
neurotoxicity
study
(
decreased
motor
activity),
occurred
only
in
one
sex
of
the
rat
(
females),
was
characterized
as
minimal,
and
may
have
been
a
result
of
the
use
of
the
gavage
dosing
in
the
study.
The
decreased
motor
activity
was
not
replicated
following
repeated
dietary
administration
(
non­
gavage)
at
lower
and
higher
doses
(
10,
70
or
200
mg/
kg/
day)
in
the
subchronic
neurotoxicity
study
in
the
same
species
(
rats).
Further,
using
a
safety
factor
of
3X
produces
a
regulatory
endpoint
lower
than
the
acute
effect
levels
in
other
standard
studies
for
determining
an
acute
endpoint,
developmental
toxicity
studies
in
two
species,
and
in
another
study
that
is
on
occasion
used
for
such
a
purpose,
the
developmental
neurotoxicity
study
in
rats.
Also
in
these
objections,
NRDC
claims
that
EPA
failed
to
calculate
residential
risks
for
some
scenarios,
based
on
low
toxicity
(
no
endpoints
were
chosen).
On
October
8,
2002,
the
Health
Effects
Division
(
HED),
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
reviewed
the
hazard
database
for
imidacloprid
and
established
additional
endpoints.
Endpoints
were
chosen
for
each
of
the
following
exposure
scenarios:
acute
dietary,
chronic
dietary,
short­
term
oral,
intermediate­
term
oral,
short­
term
dermal,
intermediate­
term
dermal,
long­
term
dermal,
short­
term
inhalation,
intermediate­
term
inhalation,
and
long­
term
inhalation.
In
the
current
risk
assessment
(
Unit
E
of
this
document),
EPA
calculated
shortterm
residential
risks
(
oral,
dermal,
and
inhalation)
for
both
adults
and
children
for
a
wide­
range
of
representative
scenarios,
including
applications
to
lawns,
ornamental
plantings,
indoor
and
outdoor
potted
plants,
and
dogs
and
cats.
Based
on
current
residential
use
patterns
for
imidacloprid,
EPA
expects
the
duration
of
exposure
to
be
shortterm
(
1­
30
days),
and
would
not
result
in
intermediate
or
long­
term
exposure.
EPA
also
conducted
human
health
aggregate
risk
assessments
for
the
following
exposure
scenarios:
acute
aggregate
(
food
+
drinking
water),
shortterm
aggregate
exposure
(
food
+
drinking
water
+
residential),
and
chronic
aggregate
exposure
(
food
+
drinking
water).

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00043
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35308
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
established
(
40
CFR
180.472)
for
the
combined
residues
of
imidacloprid,
in
or
on
a
variety
of
raw
agricultural
commodities.
Meat,
milk,
poultry
and
egg
tolerances
have
also
been
established
for
the
combined
residues
of
imidacloprid.
In
conducting
dietary
exposure
assessments
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDT)
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
[
1994­
1996
and
1998]
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
1994­
96
and
1998
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
imidacloprid
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.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
[
1994
 
1996/
1998]
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
A
Tier
1,
deterministic
acute
dietary
exposure
assessment
was
conducted
using
tolerance­
level
residues,
100%
crop
treated
(
CT)
information
for
registered
and
proposed
commodities;
and
modified
DEEMTM
(
version
7.76)
processing
factors
for
some
commodities
based
on
guideline
processing
studies.
EPA
estimated
exposure
based
on
the
95th
percentile
value
from
this
deterministic
exposure
assessment.
In
its
objections
to
a
separate
imidacloprid
tolerance
action,
NRDC
asserts
that
EPA
erred
by
relying
on
the
exposure
value
for
the
95th
percentile
of
the
population
in
estimating
exposure.
NRDC
claims
that
this
approach
leaves
5
percent
of
the
population
unprotected.
These
comments
by
NRDC
represent
a
misunderstanding
of
EPA's
exposure
assessments.
Although
EPA
estimated
exposure
using
the
95th
percentile,
EPA
most
definitely
was
not,
however,
acting
in
a
manner
designed
to
protect
only
95
percent
of
the
population.
To
the
contrary,
EPA's
exposure
estimates
were
designed
to
reasonably
capture
the
full
range
of
exposures
in
each
population
subgroup.
As
explained
in
its
science
policy
paper
on
this
subject,
EPA,
in
estimating
exposure
for
population
subgroups,
generally
considers
various
population
percentiles
of
exposure
between
95
and
99.99,
depending
on
the
extent
of
overestimation
in
the
residue
data
used
in
the
assessment.
In
each
exposure
assessment
EPA
is
attempting
to
reasonably
estimate
the
full
range
of
exposures
in
a
subgroup.
Accordingly,
as
EPA
noted
in
its
policy
paper,
just
as
when
OPP
uses
the
95th
percentile
with
non­
probabilistic
exposure
assessments
OPP
is
not
suggesting
that
OPP
is
leaving
5
percent
of
the
population
unprotected,
OPP
is
not
by
choosing
the
99.9th
percentile
for
probabilistic
exposure
assessments
concluding
that
only
99.9
percent
of
the
population
deserves
protection.
Rather,
it
is
OPP's
view
that,
with
probabilistic
assessments,
the
use
of
the
99.9th
percentile
generally
produces
a
reasonable
high­
end
exposure
such
that
if
that
exposure
does
not
exceed
the
safe
level,
OPP
can
conclude
there
is
a
reasonable
certainty
of
no
harm
to
the
general
population
and
all
significant
population
groups.
(
Office
of
Pesticide
Programs,
EPA,
Choosing
a
Percentile
of
Acute
Dietary
Exposure
as
a
Threshold
of
Regulatory
Concern
31
(
March
22,
2000)).
Importantly,
EPA
generally
uses
a
population
percentile
of
95
when
EPA
relies
on
worst
case
residue
values
­
i.
e.,
all
crops
covered
by
the
tolerance
contain
residues
at
the
tolerance
value.
Even
at
the
95th
percentile
of
estimated
exposure,
actual
exposure,
when
based
on
this
assumption
tends
to
be
significantly
overstated.
For
example,
EPA
has
found
that
when
it
uses
realistic
residue
information
(
e.
g.,
data
from
monitoring
of
the
food
supply),
that
exposure
estimates
are
generally
substantially
lower
even
at
the
99.99th
percentile.
As
noted
above,
EPA
did
use
the
worst
case
assumption
that
all
food
covered
by
imidacloprid
tolerances
would
bear
residues
at
the
tolerance
level.
Hence,
EPA
believes
its
exposure
estimate
is
unlikely
to
understate
exposure;
rather,
in
all
likelihood,
the
estimate
probably
substantially
overstates
exposure.
ii.
Chronic
exposure.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
The
chronic
dietary
exposure
assessment
was
performed
using
published
and
proposed
tolerance
levels,
DEEM
default
processing
factors,
and
percent
crop
treated
information
on
some
commodities.
iii.
Cancer.
A
quantitative
cancer
aggregate
risk
assessment
was
not
performed
because
imidacloprid
is
not
carcinogenic.
Section
408(
b)(
2)(
F)
of
the
FFDCA
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
CT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
percent
CT.
The
Agency
used
CT
information
as
follows:
For
the
acute
assessment,
100%
CT
was
assumed
for
all
registered
and
proposed
commodities.
For
the
chronic
assessment,
average
weighted
percent
CT
information
was
used
for
the
following
commodities:
Apple
34%;
brussels
sprouts
56%;
broccoli
35%;
cabbage
14%;
cantaloupe
31%;
cauliflower
52%;
collards
10%;
corn,
field
1%;
cotton
3%;
cucumber
2%;
eggplant
36%;
grapefruit
3%;
grape
32%;
mustard
greens16%;
honeydew
26%;
kale
30%;
lemon
1%;
lettuce,
head
49%;
lime
5%;
orange
1%;
pear
16%;
pepper
62%;
pumpkin
7%;
spinach
15%;
squash
7%;
sugarbeet
1%;
tangerine
9%;
tomato
9%;
watermelon
6%;
wheat
1%.
A
default
value
of
1%
was
used
for
all
commodities
which
were
reported
as
having
<
1%
CT.
The
Agency
believes
that
the
three
conditions
listed
in
Unit.
III.
E.
have
been
met.
With
respect
to
Condition
1,
percent
CT
estimates
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
EPA
uses
a
weighted
average
percent
CT
for
chronic
dietary
exposure
estimates.
This
weighted
average
percent
CT
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
percent
CT
reasonably
represents
a
person's
dietary
exposure
VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00044
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35309
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
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
percent
CT
over
a
lifetime.
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
imidacloprid
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
imidacloprid
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
imidacloprid.
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.
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
and
include
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
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
imidacloprid
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit.
III.
E.
Analysis
of
monitoring
data
for
degradates
(
ground
water
only)
shows
that
imidacloprid
parent
is
the
dominant
residue
with
imidacloprid
urea
the
most
likely
degradate.
Based
on
the
available
information,
modeling
of
total
residue
results
in
only
modest
increases
over
the
exposure
estimates
with
parent
alone.
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
imidacloprid
(
total
residue)
for
acute
exposures
are
estimated
to
be
36.04
parts
per
billion
(
ppb)
for
surface
water
and
2.09
ppb
for
ground
water.
The
EECs
for
imidacloprid
(
parent
only)
for
acute
exposures
are
estimated
to
be
35.89
parts
per
billion
(
ppb)
for
surface
water
and
1.43
ppb
for
ground
water.
The
EECs
for
imidacloprid
(
total
residue)
for
chronic
exposures
are
estimated
to
be
17.24
ppb
for
surface
water
and
2.09
ppb
for
ground
water.
The
EECs
for
imidacloprid
(
parent
only)
for
chronic
exposures
are
estimated
to
be
16.52
ppb
for
surface
water
and
1.43
ppb
for
ground
water.
The
New
York
State
Department
of
Environmental
Conservation,
Division
of
Solid
and
Hazardous
Materials
has
submitted
extensive
water
monitoring
information
from
Nassau
and
Suffolk
Counties
of
New
York.
Nassau
and
Suffolk
counties
have
ground
water
that
is
exceptionally
vulnerable
to
pesticide
contamination
and
have
a
long
history
of
a
number
of
pesticides
being
banned
from
use
in
these
counties
over
the
years.
In
general,
the
kinds
of
concentrations
of
imidacloprid
(
parent
only)
found
in
the
monitoring/
observation
and
private
drinking
water
wells
are
in
the
range
expected
in
highly
vulnerable
ground
water.
Imidacloprid
has
been
detected
in
approximately
20
(
including
some
clusters
of
wells
in
the
same
immediate
area)
out
of
about
2,000
public
and
private
water
supply
and
monitoring
wells.
Imidacloprid
was
detected
in
24
of
the
approximately
3,500
well
samples
analyzed
for
imidacloprid
in
Nassau
and
Suffolk
Counties.
Although
detection
of
imidacloprid
in
about
20
of
2,000
wells
in
an
area
with
highly
vulnerable
ground
water
does
not
demonstrate
particularly
widespread
ground
water
contamination,
3
of
2000
wells
in
this
highly
vulnerable
ground
water
have
at
least
one
detection
greater
than
the
SCIGROW
groundwater
screening
concentration
for
imidacloprid
(
parent
only)
at
1.43
ppb.
The
three
samples
that
exceed
the
SCI­
GROW
groundwater
ECs
are
reported
at
2.06
ppb,
5.98,
ppb
and
6.69
ppb.
Since
the
surface
water
model
screening
levels
are
greater
than
the
ground
water
model
screening
levels
and
the
detection
levels
reported
from
the
water
monitoring
from
Nassau
and
Suffolk
Counties,
New
York,
the
Agency
will
use
the
surface
water
ECs
for
imidacloprid
total
residue
as
a
worse
case
estimate
for
drinking
water
in
the
aggregate
risk
assessment.
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).
Imidacloprid
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Granular
products
for
application
to
lawns
and
ornamental
plants;
ready­
to­
use
spray
for
application
to
flowers,
shrubs
and
house
plants;
plant
spikes
for
application
to
indoor
and
outdoor
residential
potted
plants;
ready­
to­
use
potting
medium
for
indoor
and
outdoor
plant
containers;
liquid
concentrate
for
application
to
lawns,
trees,
shrubs
and
flowers;
readyto
use
liquid
for
directed
spot
application
to
cats
and
dogs.
In
addition,
there
are
numerous
registered
products
intended
for
use
by
commercial
applicators
to
residential
sites.
These
include
gel
baits
for
cockroach
control;
products
intended
for
commercial
ornamental,
lawn
and
turf
pest
control;
products
for
ant
control;
and
products
used
as
preservatives
for
wood
products,
building
materials,
textiles
and
plastics.

VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00045
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35310
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
As
these
products
are
intended
for
use
by
commercial
applicators
only,
they
are
not
be
addressed
in
terms
of
residential
pesticide
handler.
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
EPA
has
determined
that
residential
handlers
are
likely
to
be
exposed
to
imidacloprid
residues
via
dermal
and
inhalation
routes
during
handling,
mixing,
loading,
and
applying
activities.
Based
on
the
current
use
patterns,
EPA
expects
duration
of
exposure
to
be
short­
term
(
1­
30
days).
EPA
does
not
expect
imidacloprid
to
result
in
exposure
durations
that
would
result
in
intermediate­
or
long­
term
exposure.
The
scenarios
likely
to
result
in
adult
dermal
and/
or
inhalation
residential
handler
exposures
are
as
follows:
Dermal
and
inhalation
exposure
from
using
a
granular
push­
type
spreader.
Dermal
exposure
from
using
potted
plant
spikes.
Dermal
exposure
from
using
a
plant
potting
medium.
Dermal
and
inhalation
exposure
from
using
a
garden
hose­
end
sprayer
(
dermal
and
inhalation
exposure
from
using
a
RTU
trigger
pump
spray
is
expected
to
be
negligible).
Dermal
and
inhalation
exposure
from
using
a
water
can/
bucket
for
soil
drench
applications.
Dermal
exposure
from
using
pet
spoton
EPA
has
also
determined
that
there
is
potential
for
short­
term
(
1
to
30
days),
post­
application
exposure
to
adults
and
children/
toddlers
from
the
many
residential
uses
of
imidacloprid.
Due
to
residential
application
practices
and
the
half­
lives
observed
in
the
turf
transferable
residue
study,
intermediate­
and
long­
term
post­
application
exposures
are
not
expected.
The
scenarios
likely
to
result
in
dermal
(
adult
and
child/
toddler),
and
incidental
non­
dietary
(
child/
toddler)
short­
term
post­
application
exposures
are
as
follows:
Toddler
oral
hand­
to­
mouth
exposure
from
contacting
treated
turf.
Toddler
incidental
oral
ingestion
of
granules.
Toddler
incidental
oral
ingestion
of
pesticide­
treated
soil.
Toddler
incidental
oral
exposure
from
contacting
treated
pet.
Toddler
dermal
exposure
from
contacting
treated
turf.
Toddler
dermal
exposure
from
hugging
treated
pet/
contacting
treated
pet.
Adult
dermal
exposure
from
contacting
treated
turf.
Adult
golfer
dermal
exposure
from
contacting
treated
turf.
Adolescent
golfer
dermal
exposure
from
contacting
treated
turf.
Adult
dermal
exposure
from
contacting
treated
pet]
4.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
imidacloprid
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
imidacloprid
and
any
other
substances
and
imidacloprid
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
imidacloprid
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
and
rabbit
fetuses
to
in
utero
exposure
in
developmental
studies.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
offspring
in
the
multi­
generation
reproduction
study.
There
is
evidence
of
increased
qualitative
susceptibility
in
the
rat
developmental
neurotoxicity
study,
but
the
concern
is
low
since:
i.
The
effects
in
pups
are
wellcharacterized
with
a
clear
NOAEL;
ii.
The
pup
effects
occur
in
the
presence
of
maternal
toxicity
with
the
same
NOAEL
for
effects
in
pups
and
dams;
and,
iii.
The
doses
and
endpoints
selected
for
regulatory
purposes
are
protective
of
the
pup
effects
noted
at
higher
doses
in
the
developmental
neurotoxicity
study.
Therefore,
there
are
no
residual
uncertainties
for
pre­/
post­
natal
toxicity
in
this
study.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
imidacloprid
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X
for
the
following
reasons:
The
toxicological
database
is
complete
for
FQPA
assessment.
The
acute
dietary
food
exposure
assessment
utilizes
existing
and
proposed
tolerance
level
residues
and
100%
CT
information
for
all
commodities.
By
using
these
screeninglevel
assessments,
actual
exposures/
risks
will
not
be
underestimated.
The
chronic
dietary
food
exposure
assessment
utilizes
existing
and
proposed
tolerance
level
residues
and
%
CT
data
verified
by
the
Agency
for
several
existing
uses.
For
all
proposed
uses,
100%
CT
is
assumed.
The
chronic
assessment
is
somewhat
refined
and
based
on
reliable
data
and
will
not
underestimate
exposure/
risk.
The
dietary
drinking
water
assessment
utilizes
water
concentration
values
generated
by
model
and
associated
modeling
parameters
which
are
designed
to
provide
conservative,
health
protective,
high­
end
estimates
of
water
concentrations
which
will
not
likely
be
exceeded.
The
residential
handler
assessment
is
based
upon
the
residential
standard
operating
procedures
(
SOPs)
in
conjunction
with
chemical­
specific
study
data
in
some
cases
and
the
Pesticide
Handlers
Exposure
Database
(
PHED)
unit
exposures
in
other
cases.
The
majority
of
the
residential
postapplication
assessment
is
based
upon
chemical­
specific
turf
transferrable
residue
data
or
other
chemical­
specific
post­
application
exposure
study
data.
The
chemical­
specific
study
data
as
well
as
the
surrogate
study
data
used
are
reliable
and
also
are
not
expected
to
VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00046
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35311
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
underestimate
risk
to
adults
as
well
as
to
children.
In
a
few
cases
where
chemical­
specific
data
were
not
available,
the
SOPs
were
used
alone.
The
residential
SOPs
are
based
upon
reasonable
worst­
case
assumptions
and
are
not
expected
to
underestimate
risk.
These
assessments
of
exposure
are
not
likely
to
underestimate
the
resulting
estimates
of
risk
from
exposure
to
imidacloprid.
In
its
objections
to
a
separate
imidacloprid
tolerance
action,
NRDC
argues
that
in
light
of
the
outstanding
data
requirement
for
prospective
groundwater
monitoring
studies,
EPA
should
have
retained
a
10X
FQPA
factor
for
imidacloprid.
EPA
disagrees.
Two
small­
scale
prospective
ground­
water
monitoring
studies
were
originally
requested
by
the
Agency
in
1994.
This
request
predates
the
development
of
the
Tier
1
ground­
water
screening
model
in
1997
and
the
Food
Quality
Protection
Act
of
1996.
The
field
phase
of
these
prospective
ground­
water
monitoring
studies
commenced
in
1996.
Results
from
these
studies
have
now
been
received
and
the
levels
of
imidacloprid
observed
(
0.1
ppb)
are
below
the
screening
concentration
of
2.09
ppb
calculated
on
the
basis
of
the
SCIGROW
the
Tier
1
ground­
water
screening
model.
In
any
event,
as
noted
above,
since
higher
values
are
predicted
for
imidacloprid
residues
in
surface
water,
these
higher
values
were
used
in
conducting
the
risk
assessment.
E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
imidacloprid
will
occupy
25%
of
the
aPAD
for
the
U.
S.
population,
17%
of
the
aPAD
for
females
13
to
49
years,
54%
of
the
aPAD
for
infants
<
1
year
old
and
64%
of
the
aPAD
for
children
1­
2
years.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
imidacloprid
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
aPAD,
as
shown
in
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
IMIDACLOPRID
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
Population
0.14
25
36.04
2.09
3,700
Females
13
 
49
years
0.14
17
36.04
2.09
3,500
Infants
<
1
year
0.14
54
36.04
2.09
650
Children
1
 
2
years
0.14
64
36.04
2.09
510
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
imidacloprid
from
food
will
utilize
11%
of
the
cPAD
for
the
U.
S.
population,
26%
of
the
cPAD
for
infants
<
1
year
and
35%
of
the
cPAD
for
children
1­
2
years.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
imidacloprid
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
imidacloprid
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
4
of
this
unit:

VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00047
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35312
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
IMIDACLOPRID
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.057
11
17.24
2.09
1,800
Infants
<
1
year
0.057
26
17.24
2.09
420
Children
1­
2
years
0.057
35
17.24
2.09
370
Females
13­
49
years
0.057
8.3
17.24
20.9
1,600
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).
Short­
term
aggregate
risk
assessments
are
needed
for
adults
as
there
is
potential
for
both
dermal
and
inhalation
handler
exposure,
and
dermal
postapplication
exposure
from
the
residential
uses
of
imidacloprid
on
turf
and
pets.
In
addition,
short­
term
aggregate
risk
assessments
are
needed
for
children/
toddlers
because
there
is
a
potential
for
oral
and
dermal,
postapplication
exposure
resulting
from
the
residential
uses
of
imidacloprid
on
turf
and
pets.
The
pet­
treatment
scenario
resulted
in
the
lowest
combined
MOE
for
adults
(
MOE
=
400;
handler
and
post­
application)
and
children
(
MOE
=
260;
post­
application).
The
turftreatment
resulted
in
much
lower
exposures
for
both
adults
(
MOE
=
15,000;
handler
and
post­
application)
and
children
(
MOE
=
1,500;
postapplication
Therefore,
the
pettreatment
exposure
estimates
were
aggregated
with
the
chronic
dietary
(
food)
to
provide
a
worst­
case
estimate
of
short­
term
aggregate
risk
for
the
U.
S.
population
and
children
1­
2
years
old
(
the
child
population
subgroup
with
the
highest
estimated
chronic
dietary
food
exposure).
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
320
for
the
U.
S.
population,
and
170
for
children
1­
2
years.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
imidacloprid
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
IMIDACLOPRID
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

U.
S.
Population
320
100
17.24
2.09
2,400
Children
1­
2
years
old
170
100
17.24
2.09
410
4.
Aggregate
cancer
risk
for
U.
S.
population.
There
is
no
evidence
of
carcinogenicity
to
humans
based
on
carcinogenicity
studies
in
male
and
female
rats
and
mice.
The
Agency
concludes
that
pesticidal
uses
of
imidacloprid
are
not
likely
to
pose
a
cancer
risk
to
humans.
5.
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
imidacloprid
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methods
are
available
for
determination
of
imidacloprid
residues
of
concern
in
plant
(
Bayer
Gas
Chromatography/
Mass
Spectrometry
(
GC/
MS)
Method
00200)
and
livestock
commodities
(
Bayer
GC/
MS
Method
00191).
These
methods
have
undergone
successful
EPA
petition
method
validations
(
PMVs),
and
the
registrant
has
fulfilled
the
remaining
requirements
for
additional
raw
data,
method
validation,
independent
laboratory
validation
(
ILV),
and
an
acceptable
confirmatory
method
(
high
performance
liquid
chromatography/
ultraviolet
(
HPLC/
UV)
Method
00357).
The
methods
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
email
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
established
Codex
maximum
residue
limits
(
MRLs)
for
imidacloprid
in/
on
the
commodities
in
the
subject
petitions.
There
are
currently
Canadian
and
Mexican
MRLs
for
imidacloprid
and
metabolites
containing
the
6­
chloropicolyl
moiety
in
potatoes
at
0.3
ppm.
The
Mexican
and
Canadian
MRLs
are
not
equivalent
to
the
US­
recommended
tolerance
level.
Therefore,
harmonization
is
not
possible
at
this
time.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
combined
residues
of
imidacloprid,
its
metabolites
containing
the
6­
chloropyridinyl
moiety,
all
expressed
as
the
parent,
in
or
on
banana
(
import)
at
0.02
ppm;
cranberry;
mustard,
seed;
corn,
pop,
grain
at
0.05
ppm;
corn,
pop,
stover
at
0.20
ppm;
vegetable,
root
and
tuber,
group
1,
except
sugar
beet
at
0.40
ppm;
strawberry
at
0.50
ppm;
acerola;
avocado;
canistel;
feijoa;
guava;
jaboticaba;
mango;
okra;
papaya;
passionfruit;
sapodilla;
sapote,
black;
sapote,
mamey;
star
apple;
starfruit;
wax
VerDate
Jan<
31>
2003
17:
32
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00048
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35313
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
jambu
at
1.0
ppm;
artichoke,
globe
at
2.5
ppm;
fruit,
stone,
group
12;
lychee;
longan;
Spanish
lime;
rambutan;
pulasan;
persimmon
at
3.0
ppm;
currant;
elderberry;
gooseberry;
huckleberry;
juneberry;
lingonberry;
salal;
watercress
at
3.5
ppm;
vegetable,
leaves
of
root
and
tuber,
group
2;
vegetable,
legume,
group
6,
except
soybean
at
4.0
ppm.

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

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0103
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
August
12,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA
 
.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0103,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00049
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35314
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
June
2,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

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

PART
180
 
[
AMENDED]

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

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


2.
Section
180.472
is
amended:
i.
In
paragraph
(
a),
in
the
table,
by
removing
the
commodities,
``
bean,
edible,
podded,''
``
bean,
succulent,
shelled,''
``
dasheen,
leaves,''
``
mango,''
``
potato,''
``
turnip,
greens,''
and
``
vegetable,
tuberous
and
corm,
subgroup;''
and
by
alphabetically
adding
the
following
commodities.
ii.
In
paragraph
(
b),
in
the
table,
by
removing
the
commodities,
``
fruit,
stone,''
``
strawberry,''
``
turnip,
roots,''
and
``
turnip,
tops.''
The
additions
read
as
follows:
§
180.472
Imidacloprid;
tolerances
for
residues.
(
a)
*
*
*

Commodity
Parts
per
million
Acerola
............................
1.0
*
*
*
*
*

Artichoke,
globe
..............
2.5
Avocado
..........................
1.0
Bananna1
........................
0.02
*
*
*
*
*

Canistel
...........................
1.0
*
*
*
*
*

Corn,
pop,
grain
..............
0.05
Corn,
pop,
stover
............
0.20
*
*
*
*
*

Cranberry
........................
0.05
Currant
............................
3.5
*
*
*
*
*

Elderberry
.......................
3.5
*
*
*
*
*

Feijoa
..............................
1.0
*
*
*
*
*

Fruit,
stone,
group
12
.....
3.0
Gooseberry
.....................
3.5
*
*
*
*
*

Guava
.............................
1.0
*
*
*
*
*

Huckleberry
.....................
3.5
Jaboticaba
......................
1.0
Juneberry
........................
3.5
*
*
*
*
*

Lingonberry
.....................
3.5
Longan
............................
3.0
Lychee
............................
3.0
Mango
.............................
1.0
*
*
*
*
*

Mustard,
seed
.................
0.05
Okra
................................
1.0
Passionfruit
.....................
1.0
Papaya
............................
1.0
*
*
*
*
*

Persimmon
......................
3.0
*
*
*
*
*

Pulasan
...........................
3.0
Rambutan
.......................
3.0
Salal
................................
3.5
Sapodilla
.........................
1.0
Sapote,
black
..................
1.0
Sapote,
mamey
..............
1.0
*
*
*
*
*

Spanish
lime
...................
3.0
Star
apple
.......................
1.0
Starfruit
...........................
1.0
Strawberry
......................
0.50
*
*
*
*
*

Vegetable,
leaves
of
root
and
tuber,
group
2
......
4.0
Vegetable,
legume,
except
soybean,
group
6
4.0
VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00050
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1
35315
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Vegetable,
root
and
tuber,
group
1,
except
sugar
beet
...................
0.40
*
*
*
*
*

Watercress
......................
3.5
Wax
jambu
......................
1.0
*
*
*
*
*

1
There
are
no
U.
S.
registration
as
of
June
13,
2003
for
use
on
banana.

*
*
*
*
*
[
FR
Doc.
03
 
14880
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
725
[
OPPT
 
2002
 
0041;
FRL
 
7200
 
3]

RIN
2070
 
AD43
Burkholderia
Cepacia
Complex;
Significant
New
Use
Rule
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
EPA
is
issuing
a
significant
new
use
rule
(
SNUR)
under
section
5(
a)(
2)
of
the
Toxic
Substances
Control
Act
(
TSCA)
for
Burkholderia
cepacia
complex
(
Bcc),
a
group
of
naturallyoccurring
microorganisms.
Bcc
microorganisms,
when
encountered
in
sufficient
numbers
through
an
appropriate
route
of
exposure
by
a
member
of
a
sensitive
population,
such
as
a
cystic
fibrosis
(
CF)
patient,
have
the
potential
to
cause
a
severe
infection,
resulting
in
significantly
increased
rates
of
mortality.
This
rule
would
require
persons
who
intend
to
manufacture,
import,
or
process
any
individual
member
of
Bcc
for
a
significant
new
use
to
notify
EPA
at
least
90
days
before
commencing
the
manufacturing
(
including
import)
or
processing
of
Bcc
for
a
use
designated
by
this
SNUR
as
a
significant
new
use.
The
required
notice
would
provide
EPA
with
the
opportunity
to
evaluate
the
intended
new
use
and
associated
activities
and,
if
necessary,
to
prohibit
or
limit
that
activity
before
it
occurs.
DATES:
This
final
rule
is
effective
on
August
12,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
James
Alwood,
Chemical
Control
Division,
Office
of
Pollution
Prevention
and
Toxics
(
7405M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8974;
e­
mail
address:
alwood.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
manufacture
(
including
import),
process,
or
use
products
that
contain
living
microorganisms
subject
to
jurisdiction
under
TSCA,
especially
if
you
know
that
your
products
contain
or
may
contain
members
of
Bcc.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Chemical
manufacturers
(
NAICS
325),
e.
g.,
Persons
manufacturing,
importing,
or
processing
products
for
commercial
purposes
containing
Bcc
for
biofertilizers;
biosensors;
biotechnology
reagents;
commodity
or
specialty
chemical
production;
energy
applications;
and
other
TSCA
uses.
 
Waste
management
and
remediation
(
NAICS
562),
e.
g.,
Waste
treatment
or
pollutant
degradation.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
list
of
substances
excluded
by
TSCA
section
(
3)(
2)(
B),
and
the
applicability
provisions
in
40
CFR
725.105(
c)
for
SNUR
related
obligations.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2002
 
0041.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102­
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
The
OPPTS
harmonized
test
guideline
referenced
in
this
document
is
available
at
http:/
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
A
frequently
updated
electronic
version
of
40
CFR
part
725
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr725_
00.
html,
a
beta
site
currently
under
development.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
identification
number.

II.
Background
A.
What
Action
is
the
Agency
Taking?

This
SNUR
will
require
persons
to
notify
EPA
at
least
90
days
before
commencing
the
manufacture,
import,
or
processing
of
any
member
of
Bcc,
a
group
of
naturally
occurring
microorganisms,
for
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.

VerDate
Jan<
31>
2003
16:
29
Jun
12,
2003
Jkt
200001
PO
00000
Frm
00051
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
13JNR1.
SGM
13JNR1