Document ID: EPA-HQ-OPP-2003-0172-0001
Agency: epa
Document Type: Notice
Title: Flonicamid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain               Pesticide Chemical in or on Food
Posted Date: 2003-05-23T04:00Z

28218
Federal
Register
/
Vol.
68,
No.
100
/
Friday,
May
23,
2003
/
Notices
EPA
is
providing
an
opportunity,
through
this
notice,
for
interested
parties
to
provide
written
comments
and
input
to
the
Agency
on
the
risk
assessments
or
risk
mitigation
proposals
for
the
pesticide
specified
in
this
notice.
Such
comments
and
proposals
could
address
ideas
on
how
to
manage
potential
residential
cancer
risks
from
the
use
of
MGK
 
Repellent
326
as
an
insect
repellent,
for
example,
the
feasibility
of
using
a
lower
percent
active
ingredient
in
final
products
containing
MGK
 
Repellent
326.
Comments
could
also
address
the
availability
of
additional
data
to
further
refine
the
risk
assessments,
such
as
information
on
the
extent
and
duration
of
use
of
products
containing
MGK
 
Repellent
326.
Last,
comments
could
address
the
Agency's
risk
assessment
methodologies
and
assumptions
applied
to
this
specific
chemical.
Comments
should
be
limited
to
issues
raised
within
the
risk
assessment
and
associated
documents.
All
comments
should
be
submitted
by
[
insert
date
60
days
after
date
of
publication
in
theFederal
Register]
using
the
methods
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
Comments
will
become
part
of
the
Agency
record
for
MGK
 
Repellent
326.

List
of
Subjects
Environmental
protection,
Chemicals,
MGK
 
Repellent
326,
Pesticides
and
pest.

Dated:
May
14,
2003.
Lois
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
13006
Filed
5
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0172;
FRL
 
7307
 
5]

Flonicamid;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0172,
must
be
received
on
or
before
June
23,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Ann
Sibold,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6502];
e­
mail
address:
sibold.
ann@
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
a
commercial
grower
of
food
or
feed
crops.
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.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0172.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket,
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
on
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
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18:
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28219
Federal
Register
/
Vol.
68,
No.
100
/
Friday,
May
23,
2003
/
Notices
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also,
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties,
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment,
will
be
included,
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0172.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
number
OPP
 
2003
 
0172.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
number
OPP
 
2003
 
0172.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
number
OPP
 
2003
 
0172.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed,
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

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Federal
Register
/
Vol.
68,
No.
100
/
Friday,
May
23,
2003
/
Notices
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
May
13,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
ISK
Bioscience
Corporation,
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

ISK
Biosciences
Corporation
PP
3F6552
EPA
has
received
a
pesticide
petition
[
3F6552]
from
ISK
Biosciences
Corporation,
7470
Auburn
Road,
Suite
A,
Concord,
Ohio,
44077,
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
tolerances
for
the
combined
residues
of
the
insecticide
flonicamid,
(
N­
cyanomethyl­
4­
trifluoromethylnicotinamide)
and
its
metabolites,
TFNA,
(
4­
trifluoromethylnicotinic
acid),
TFNAAM
(
4­
trifluoromethylnicotinamide)
and
TFNG,
(
N­(
4­
trifluoromethylnicotinoyl)­
glycine)
in
or
on
the
raw
agricultural
commodities:
Celery,
at
1.2
parts
per
million
(
ppm);
cotton,
at
0.5
ppm;
cotton,
gin
trash,
at
6.0
ppm;
cotton,
hulls,
at
1.0
ppm;
cotton,
meal,
at
1.0
ppm;
fruit,
pome,
group
11,
at
0.2
ppm;
fruit,
stone,
group
12,
except
plum
and
fresh
prune
plum,
at
0.7
ppm;
lettuce,
head,
at
1.0
ppm;
lettuce,
leaf,
at
4.0
ppm;
plum,
at
0.1
ppm;
potato,
at
0.2
ppm;
potato,
flakes,
at
0.4
ppm;
prune,
fresh,
at
0.1;
spinach,
at
9.0
ppm;
tomato,
paste,
at
2.0
ppm;
tomato,
puree,
at
0.5
ppm;
vegetable,
cucurbit,
group
9,
at
0.4
ppm;
vegetable,
fruiting,
group
8,
at
0.4
ppm;
by
establishing
tolerances
for
the
combined
residues
of
the
insecticide
flonicamid,
(
N­
cyanomethyl­
4­
trifluoromethylnicotinamide)
and
its
metabolite
TFNA­
AM,
(
4­
trifluoromethylnicotinamide)
in
animal
tissues
and
poultry
meat
byproducts:
Cattle,
fat,
at
0.01
ppm;
cattle,
meat,
at
0.04
ppm;
eggs,
at
0.02
ppm;
goat,
fat,
at
0.01
ppm;
goat,
meat,
at
0.04
ppm;
hog,
fat,
at
0.01;
hog,
meat,
at
0.01
ppm;
horse,
fat,
at
0.01
ppm;
horse,
meat,
at
0.04
ppm;
milk,
at
0.02
ppm;
poultry,
fat,
at
0.01
ppm;
poultry,
meat,
at
0.01
ppm;
poultry,
meat
byproducts,
at
0.01
ppm;
sheep,
fat,
at
0.01
ppm;
sheep,
meat,
at
0.04
ppm;
by
establishing
tolerances
for
the
combined
residues
of
the
insecticide
flonicamid,
(
Ncyanomethyl
4­
trifluoromethylnicotinamide)
and
its
metabolites
TFNA,
(
4­
trifluoromethylnicotinic
acid)
and
TFNA­
AM,
(
4­
trifluoromethylnicotinamide)
in
the
animal
meat
byproducts:
cattle,
meat
byproducts,
at
0.06
ppm;
goat,
meat
byproducts,
at
0.06
ppm;
hog,
meat
byproducts,
at
0.01
ppm;
horse,
meat
byproducts,
at
0.06
ppm;
and
sheep,
meat
byproducts,
at
0.06
ppm.

A.
Residue
Chemistry
1.
Plant
metabolism.
Wheat,
potato
and
peach
metabolism
studies
were
conducted
using
[
14C]­
pyridylflonicamid
The
metabolic
profile
was
similar
for
all
three
matrices.
The
major
metabolites
for
the
various
crops
were:
TFNA
in
peach,
TFNA
and
TFNG
in
potato,
and
TFNG
in
wheat.
The
metabolism
of
flonicamid
in
plants
shows,
the
main
pathway
of
metabolism
involves
hydrolysis
of
­
CN
and
CONH2
functional
groups
in
the
molecule.
The
metabolism
of
flonicamid
in
plants
is
well
understood.
2.
Analytical
method.
Analytical
methodology
has
been
developed
to
determine
the
residues
of
flonicamid
and
its
three
major
plant
metabolites,
TFNA,
TFNG,
and
TFNA­
AM
in
various
crops.
The
residue
analytical
method
for
the
majority
of
crops
includes
an
initial
extraction
with
acetonitrile
(
ACN)/
deionized
(
DI)
water,
followed
by
a
liquid­
liquid
partition
with
ethyl
acetate.
The
residue
method
for
wheat
straw
is
similar,
except
that
a
C18
solid
phase
extraction
(
SPE)
is
added
prior
to
the
liquid­
liquid
partition.
The
final
sample
solution
is
quantitated
using
a
liquid
chromatograph
(
LC)
equipped
with
a
reverse
phase
column
and
a
triple
quadruple
mass
spectrometer
(
MS/
MS).
3.
Magnitude
of
residues.
Residue
data
were
collected
on
various
crops
and
crop
groups
during
field
trials.
Maximum
total
residues
for
cucurbits
(
total
of
17
field
trials)
ranged
from
0.164
(
summer
squash)
to
0.333
ppm
(
cucumber).
Maximum
total
residues
for
stone
fruits
(
total
of
21
field
trials)
ranged
from
0.092
(
plum)
to
0.520
ppm
(
cherry).
Maximum
total
residues
for
pome
fruits
(
total
of
18
field
trials)
ranged
from
0.054
(
pears)
to
0.169
ppm
(
apples).
Maximum
total
residues
for
fruiting
vegetables
(
total
of
21
field
trials)
ranged
from
0.195
(
bell
pepper)
to
0.290
ppm
(
non­
bell
pepper).
Maximum
total
residues
for
leafy
vegetables
(
total
of
24
field
trials)
ranged
from
0.049
(
head
lettuce
without
wrappers)
to
7.978
ppm
(
spinach).
Maximum
total
residues
for
cottonseed
with
linters
(
12
field
trials)
were
0.343
and
for
gin
trash
were
5.001
ppm.
Maximum
total
residues
for
potatoes
(
total
of
17
field
trials)
were
0.119
ppm.

B.
Toxicological
Profile
1.
Acute
toxicity.
A
battery
of
acute
toxicity
studies
was
conducted
which
placed
flonicamid
technical
in
Toxicity
Category
III
for
oral
lethal
dose
(
LD)
50,
Category
IV
for
dermal
LD50,
inhalation
LC50,
dermal
irritation,
and
eye
irritation.
Flonicamid
technical
is
not
a
dermal
sensitizer.
In
an
acute
neurotoxicity
study,
the
no
observed
adverse
effect
levels
(
NOAELs)
for
neurotoxicity
were
600
milligrams/
kilogram
(
mg/
kg)
in
males
and
1,000
mg/
kg
in
female
(
highest
doses
tested).
The
systemic
NOAELs
were
600
mg/
kg
in
males
and
300
mg/
kg
in
females.
2.
Genotoxicty.
Flonicamid
technical
did
not
cause
mutations
in
the
bacterial
reverse
mutation
or
mouse
lymphoma
tests
with
or
without
metabolic
activation,
chromosome
damage
in
the
mouse
micronucleus
or
cytogenetics
tests
with
and
without
metabolic
activation,
an
increase
in
DNA
damage
in
the
comet
assay
or
in
an
in
vivo
rat
unscheduled
DNA
synthesis
(
UDS)
study.
Based
on
the
weight
of
evidence,
it
is
concluded
that,
flonicamid
technical
is
not
genotoxic.
3.
Reproductive
and
developmental
toxicity.
A
developmental
toxicity
study
in
rats
resulted
in
the
maternal
and
developmental
no
observed
adverse
effect
levels
(
NOAELs)
of
100
mg/
kg/
day.
The
maternal
lowest
observed
adverse
effect
level
(
LOAEL)
was
500
mg/
kg/
day
based
on
the
treatmentrelated
effects
observed
on
the
liver
and
kidney
of
the
dams
in
the
highest
dose
group.
The
developmental
LOAEL
was
500
mg/
kg/
day
based
on
the
increases
in
placental
weights
and
incidences
of
fetal
skeletal
variations
seen
only
at
maternally
toxic
doses
of
500
mg/
kg/
day.
In
the
rabbit
developmental
toxicity
study,
the
maternal
and
developmental
NOAELs
were
7.5
mg/
kg/
day
and
25
mg/
kg/
day
highest
dose
tested
(
HDT),
respectively.
The
maternal
LOAEL
was
25
mg/
kg/
day
based
on
decreased
body
weights
and
food
consumption.
No
adverse
effects
on
the
fetuses
were
observed
at
the
highest
dose.

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18:
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Federal
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/
Vol.
68,
No.
100
/
Friday,
May
23,
2003
/
Notices
In
the
multi­
generation
rat
reproduction
study,
the
NOAEL
was
300
ppm
for
both
parental
animals
(
13.5
 
32.8
and
16.3
 
67.0
mg/
kg/
day,
respectively,
for
males
and
females)
and
their
offspring.
The
effects
at
the
highest
dose
of
1,800
ppm
included
the
following:
increased
kidney
weights
and
gross
and
histopathological
alterations
in
the
kidney.
Findings
noted
in
the
top
dose
females
included
delayed
vaginal
opening
and
increased
liver,
kidney
and
spleen
weights
in
the
F1
generation
and
reduced
ovary
and
adrenal
weights
in
the
parental
generation
and
decreased
uterine
weights
in
the
F1
female
weanlings.
There
was
an
increase
in
the
FSH
and
LH
levels
in
F1
females
tested
for
these
endpoints.
These
findings
did
not
affect
the
reproductive
performance
or
survival
of
offspring
in
the
study.
4.
Subchronic
toxicity.
The
NOAEL
for
flonicamid
technical
in
the
rat
28
 
day
dermal
toxicity
study
was
1,000
mg/
kg/
day,
which
was
the
highest
dose
tested.
In
a
90
 
day
rat
feeding
study
the
NOAEL
was
established
at
200
ppm
(
12.11
mg/
kg/
day)
for
males
and
1,000
ppm
(
72.3
mg/
kg/
day)
for
females.
The
NOAELs
were
based
on
effects
on
hematology,
triglycerides,
and
pathology
in
the
liver
and
kidney.
In
a
13
 
week
mouse
study,
the
NOAEL
was
100
ppm
(
15.25
mg/
kg/
day
in
males
and
20.1
mg/
kg/
day
in
females).
The
LOAEL
is
1,000
ppm
(
153.9
mg/
kg/
day
in
males
and
191.5
mg/
kg/
day
in
females)
based
on
hematology
effects
and
changes
in
glucose,
creatinine,
bilirubin,
sodium,
chloride
and
potassium
levels,
increased
liver
and
spleen
weights
and
histopathology
findings
in
the
bone
marrow,
spleen
and
kidney.
In
a
subchronic
toxicity
study
in
dogs
with
capsule
administration,
the
NOAEL
was
20
mg/
kg/
day
based
on
findings
of
severe
toxicity
at
a
dose
exceeding
the
maximum
tolerated
dose;
symptoms
included
collapse,
prostration
and
convulsions
leading
to
early
sacrifice
at
the
LOAEL
of
50
mg/
kg/
day.
In
a
subchronic
neurotoxicity
study
in
rats,
the
NOAEL
for
dietary
administration
was
1,000
ppm
(
67
mg/
kg/
day
in
males
and
81
mg/
kg/
day
in
females)
for
systemic
toxicity
based
on
body
weight
and
food
consumption
effects.
The
NOAEL
for
neurotoxicity
was
10,000
ppm
(
625
and
722
mg/
kg/
day
in
males
and
females,
respectively
(
highest
dose
tested).
5.
Chronic
toxicity.
In
the
chronic
dog
study
with
administration
via
using
capsules,
the
NOAEL
was
8
mg/
kg/
day.
The
LOAEL
was
20
mg/
kg/
day
based
on
reduced
body
weights
in
females
and
effects
on
the
circulating
red
blood
cells.
In
a
rat
24
 
month
combined
chronic
and
oncogenicity
study,
flonicamid
technical
was
not
carcinogenic
in
rats.
The
NOAEL
was
200
ppm
(
7.32
mg/
kg/
day)
for
males
and
1,000
ppm
(
44.1
mg/
kg/
day)
for
females.
The
LOAEL
was
1,000
ppm
for
males
and
5,000
ppm
for
females
based
on
histopathology
in
the
kidney,
hematology
effects,
hepatic
effects
including
changes
in
biochemical
parameters,
increased
organ
weights,
and
histopathological
changes.
Atrophy
of
striated
muscle
fibers,
cataract
and
retinal
atrophy
observed
in
the
high
dose
females
were
considered
to
be
due
to
acceleration
of
spontaneous
age­
related
lesions.
In
the
18
 
month
mouse
study,
effects
were
observed
in
the
lung,
liver,
spleen
and
bone
marrow
at
250
ppm
or
higher.
Findings
included,
centrilobular
hepatocellular
hypertrophy,
extramedullary
hematopoiesis
and
pigment
deposition
in
the
spleen
and
decreased
cellularity
(
hypocellularity)
in
the
bone
marrow.
There
were
statistically
significant
increases
in
the
incidence
of
alveolar/
bronchiolar
adenomas
in
both
sexes
of
treated
groups
with
hyperplasia/
hypertrophy
of
epithelial
cells
in
terminal
bronchioles.
There
was
a
statistically
significant
increase
in
the
incidence
of
alveolar/
bronchiolar
carcinomas
in
males
at
750
ppm
and
2,250
ppm
and
in
females
at
2,250
ppm
only.
These
effects
in
the
lungs
of
mice
were
not
life
threatening
as
most
of
effects
were
observed
at
the
terminal
sacrifice
and
there
was
no
effect
of
treatment
on
mortality
in
the
study.
A
NOAEL
could
not
be
determined
from
the
dose
levels
administered.
Mechanism­
of­
action
studies
have
indicated
that
the
lung
effects
are
unique
to
the
mouse
and
are
not
likely
to
translate
to
other
species
including
the
rat.
Flonicamid
technical
was
not
carcinogenic
in
the
rat.
6.
Animal
metabolism.
Rat,
goat
and
poultry
metabolism
studies
were
conducted
using
[
14C]­
pyridylflonicamid
The
majority
of
the
dose
was
rapidly
excreted.
Flonicamid
was
a
major
component
of
rat
urine
48
hours
after
dosing.
TFNA­
AM
was
the
major
metabolite
found
in
rats
(
urine),
goats
(
milk
and
tissues),
and
in
laying
hens
(
tissues
and
eggs).
TFNG
was
found
between
8
 
24%
of
the
total
radioactive
residue
(
TRR)
in
the
livers
of
rats
sacrificed
at
intervals
between
0.5
 
6
hours
after
dosing.
The
liver
samples
at
these
time
intervals
had
14C­
residues
of
2.3%
 
4.6%
of
the
dose.
TFNA
was
not
a
major
component
in
animal
tissues.
The
metabolism
of
flonicamid
in
animals
shows
the
main
pathway
of
metabolism
involves
hydrolysis
of
­
CN
and
­
CONH2
functional
groups
in
the
molecule,
identical
to
plant
metabolism.
The
main
metabolic
reactions
were
hydrolysis
of
cyano
to
the
amide
function
and
ring
hydroxylation.
In
rats,
flonicamid
was
further
metabolized
by
several
routes,
including
nitrile
hydrolysis,
amide
hydrolysis,
Noxidation
and
hydroxylation
of
the
pyridine
ring,
leading
to
multiple
metabolites.
The
metabolism
of
flonicamid
in
animals
is
well
understood.
7.
Metabolite
toxicology.
The
main
metabolites
of
flonicamid
were
examined
in
acute
oral
toxicity
studies
in
rats
and
bacterial
reverse
mutation
tests.
All
the
metabolites
were
less
toxic
than
flonicamid
and
not
mutagenic.
8.
Endocrine
disruption.
No
special
studies
investigating
potential
estrogenic
or
other
endocrine
effects
of
flonicamid
have
been
conducted.
Some
suggestions
of
possible
endocrine
effects
were
reported
at
the
highest
dose
tested
(
1,800
ppm)
in
the
multi­
generation
reproduction
study
which
showed
increased
FSH
and
LH
levels,
a
delay
in
the
time
to
vaginal
opening
in
the
F1
generation,
and
reduced
ovary
and
adrenal
weights
in
the
parental
generation.
However,
there
were
no
effects
on
reproductive
performance
or
survival
of
the
offspring
in
the
study.
At
levels
that
are
expected
to
be
found
in
the
environment,
flonicamid
will
not
cause
any
endocrine­
related
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Potential
dietary
exposures
from
food
were
estimated
using
the
proposed
tolerances
for
all
crops
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM)
for
acute
and
chronic
exposure
based
on
U.
S.
Department
of
Agriculture's
(
USDA)
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
conducted
in
1994
 
1998,
and
percent
crop
treated
of
100%.
The
following
raw
agricultural
commodities
were
included:
Leaf
lettuce,
head
lettuce,
celery,
spinach,
cotton,
potatoes,
fruiting
vegetables,
cucurbits,
stone
fruits,
pome
fruits
and
resulting
secondary
residues
in
meat,
milk,
poultry
and
eggs.
i.
Food.
Acute
dietary
exposure
was
compared
to
the
acute
population
adjusted
dose
(
aPAD)
of
3.0
mg/
kg/
day
based
on
the
NOAEL
of
300
mg/
kg
from
the
acute
neurotoxicity
study
in
rats
and
a
100
 
fold
uncertainty
factor.
The
U.
S.
population
exposure
is
0.26%
of
the
aPAD
and
the
most
highly
exposed
subpopulation
is
children
1
 
2
with
0.56%
of
the
aPAD
(
95th
percentile).
Based
on
the
available
data,
an
appropriate
cPAD
is
0.073
mg/
kg/
day
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Federal
Register
/
Vol.
68,
No.
100
/
Friday,
May
23,
2003
/
Notices
based
on
the
NOEL
of
7.32
mg/
kg/
day
from
the
chronic
toxicity
study
in
rats
and
a
100­
fold
uncertainty
factor.
The
U.
S.
population
exposure
is
3.2%
of
the
cPAD
and
the
most
highly
exposed
subpopulation
exposure
is
children
1
 
6
with
7.4%
of
the
cPAD.
ii.
Drinking
water.
A
drinking
water
level
of
comparison
(
DWLOC)
was
calculated
by
subtracting
the
chronic/
acute
food
exposures
calculated
using
DEEMTM
from
the
cPAD/
aPAD
to
obtain
the
acceptable
chronic/
acute
exposure
to
flonicamid
in
drinking
water.
The
estimated
average
and
maximum
concentration
of
flonicamid
in
surface
water
is
1.20
ppb
and
1.64
ppb,
respectively.
These
are
both
well
below
the
lowest
chronic
(
676
ppb)
and
acute
(
29,831
ppb)
DWLOC
values
for
flonicamid.
Therefore,
taking
into
account
all
proposed
uses,
it
can
be
concluded
with
reasonable
certainty
that
residues
of
flonicamid
in
food
and
drinking
water
will
not
result
in
unacceptable
levels
of
human
health
risk.
2.
Non­
dietary
exposure.
There
are
currently
no
residential
uses
of
flonicamid
registered
or
pending
action
that
need
to
be
added
to
the
total
risk
from
exposure.

D.
Cumulative
Effects
In
consideration
of
potential
cumulative
effects
of
flonicamid
and
other
substances
that
may
have
a
common
mechanism
of
toxicity,
to
our
knowledge
there
are
currently
no
available
data
or
other
reliable
information
indicating
that
any
toxic
effects
produced
by
flonicamid
would
be
cumulative
with
those
of
other
chemical
compounds;
thus
only
the
potential
risks
of
flonicamid
have
been
considered
in
this
assessment
of
its
aggregate
exposure.
If
ISK
Biosciences
Corporation
learns
of
any
other
compound
with
the
same
mechanism
of
toxicity
they
will
submit
information
for
EPA
to
consider
concerning
potential
cumulative
effects
of
flonicamid
consistent
with
the
schedule
established
by
EPA
in
the
Federal
Register
of
August
4,
1997
(
62
FR
42020)
(
FRL
 
5734
 
6),
and
other
EPA
publications
pursuant
to
the
Food
Quality
Protection
Act
(
FQPA).

E.
Safety
Determination
1.
U.
S.
population.
Using
conservative
exposure
assessment
analyses,
the
acute
dietary
exposure
estimates
are
well
below
the
aPAD
of
3
milligrams/
kilogram
body
weight/
day
(
mg/
kg
bwt/
day)
for
all
population
subgroups.
In
addition,
the
chronic
dietary
exposure
estimates
for
the
various
population
groups
are
well
below
the
cPAD
of
0.073
mg/
kg
bwt/
day.
Based
on
this
information,
ISK
Biosciences
Corporation
concludes
that
there
is
reasonable
certainty
that
no
harm
will
result
from
acute
or
chronic
exposure
to
flonicamid.
2.
Infants
and
children.
Based
on
the
available
developmental
and
reproductive
data
on
flonicamid,
ISK
Biosciences
Corporation,
concludes
that,
reliable
data
support
use
of
the
standard
100
 
fold
uncertainty
factor,
and
that
an
additional
uncertainty
factor
is
not
needed
to
protect
the
safety
of
infants
and
children
under
the
FQPA.
Although,
the
reproduction
study
indicated
signs
of
toxicity
to
some
reproductive
organs/
systems
at
the
high
dose
of
1,800
ppm
in
the
diet,
other
signs
of
toxicity
such
as
effects
on
the
kidney
accompanied
these;
there
were
no
effects
observed
at
a
dose
level
of
300
ppm.
There
were
no
effects
on
reproduction
or
survival
at
any
dose
level.
Since
acute
and
chronic
aggregate
exposure
assessments
are
well
below
the
aPAD
and
cPAD
respectively,
there
is
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
flonicamid
residues.

F.
International
Tolerances
There
are
no
Canadian
or
Mexican
residue
limits
or
codex
MRLs
for
the
insecticide
flonicamid
and
its
metabolites
TFNA,
TFNA­
AM,
and
TFNG.
[
FR
Doc.
03
 
13005
Filed
5
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7502
 
9]

Proposed
Administrative
Settlement
Under
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980
Regarding
the
Central
Steel
Drum
Superfund
Site,
Newark,
NJ
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
proposed
administrative
settlement
and
opportunity
for
public
comment.

SUMMARY:
The
United
States
Environmental
Protection
Agency
(``
EPA'')
is
proposing
to
enter
into
an
administrative
settlement
to
resolve
claims
under
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980,
as
amended
(``
CERCLA''),
42
U.
S.
C.
9601
et
seq.
In
accordance
with
EPA
guidance,
notice
is
hereby
given
of
a
proposed
administrative
settlement
pursuant
to
section
122(
h)(
1)
of
CERCLA
concerning
the
Central
Steel
Drum
Superfund
Site,
located
in
Newark,
New
Jersey.
This
notice
is
being
published
to
inform
the
public
of
the
proposed
settlement
and
to
provide
the
public
with
an
opportunity
to
comment
on
the
proposed
settlement.
This
settlement
is
intended
to
resolve
the
civil
liability
of
certain
responsible
parties
for
response
costs
incurred
by
EPA
at
the
Central
Steel
Drum
Superfund
Site.
CERCLA
provides
EPA
the
authority
to
settle
certain
claims
for
response
costs
incurred
by
the
United
States
with
the
approval
of
the
Attorney
General
of
the
United
States.
The
proposed
settlement
provides
that
the
potentially
responsible
parties,
Marian
Abrams
and
Jane
Mattson,
will
pay
$
18,000.00
in
reimbursement
of
response
costs
incurred
by
EPA
in
performing
a
removal
action
to
remove
the
contaminants
and
hazardous
substances
from
the
Central
Steel
Drum
Superfund
Site
in
return
for
a
covenant
not
to
sue
under
sections
106
and
107
of
CERCLA
from
the
United
States.

DATES:
Comments
must
be
provided
on
or
before
June
23,
2003.

ADDRESSES:
Comments
should
be
addressed
to
the
U.
S.
Environmental
Protection
Agency,
Office
of
Regional
Counsel,
290
Broadway
 
17th
Floor,
New
York,
New
York
10007
 
1866
and
should
refer
to:
In
the
Matter
of
Central
Steel
Drum
Superfund
Site,
Marian
Abrams
and
Jane
Mattson,
Settling
Parties,
U.
S.
EPA
Region
II
Docket
No.
CERCLA
 
02
 
2003
 
2001.

FOR
FURTHER
INFORMATION
CONTACT:
U.
S.
Environmental
Protection
Agency,
Office
of
Regional
Counsel,
290
Broadway
 
17th
Floor,
New
York,
New
York
10007
 
1866,
Attention:
Muthu
S.
Sundram,
Esq.
(
212)
637
 
3148.

SUPPLEMENTARY
INFORMATION:
A
copy
of
the
proposed
administrative
settlement
agreement,
as
well
as
background
information
relating
to
the
settlement,
may
be
obtained
in
person
or
by
mail
from
EPA's
Region
II
Office
of
Regional
Counsel,
290
Broadway
 
17th
Floor,
New
York,
New
York
10007
 
1866.

Dated:
May
14,
2003.

George
Pavlou,

Director,
Emergency
&
Remedial
Response
Division.
[
FR
Doc.
03
 
13002
Filed
5
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
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