Document ID: EPA-HQ-OPP-2002-0350-0001
Agency: epa
Document Type: Notice
Title: Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-07T05:00Z

11100
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
mg/
kg/
day
for
female
dogs
in
the
control
through
high­
dose
groups,
respectively,
with
a
NOAEL
of
24.9
mg/
kg/
day
for
males
and
29.6
mg/
kg/
day
for
females
based
on
hematology
effects
and
microscopic
liver
changes.
An
18
 
month
feeding/
carcinogenicity
study
in
mice
was
conducted
with
dietary
intake
of
0,
46.6,
93.9,
160.5,
or
337.6
mg/
kg/
day
for
males
and
0,
58.0,
116.9,
198.0,
or
407.1
mg/
kg/
day
for
females.
A
NOAEL
of
93.9
mg/
kg/
day
in
males
and
116.9
mg/
kg/
day
in
females
was
based
on
decreases
in
Hgb
and
HCT.
There
were
no
treatment­
related
increases
in
tumors
of
any
kind
observed
at
any
dose
level.
In
a
24
 
month
chronic
feeding/
carcinogenicity
study
in
rats
at
dietary
doses
of
0,
24.3,
40.0,
82.8,
or
123.5
mg/
kg/
day
for
males
and
20.0,
36.4,
67.0,
or
124.7
mg/
kg/
day
for
females,
an
overall
NOAEL
of
40.0
mg/
kg/
day
in
males
and
36.4
mg/
kg/
day
in
females
was
based
on
hematology
effects
and
reduced
body
weights.
There
was
no
evidence
of
a
carcinogenic
response.
6.
Animal
metabolism.
A
metabolism
study
in
rats
indicated
that
approximately
84
to
104%
of
the
orally
administered
dose
of
sulfentrazone
was
excreted
in
the
urine,
and
that
the
pooled
urinary
radioactivity
consisted
almost
entirely
of
3­
hydroxymethyl
sulfentrazone.
Pooled
fecal
radioactivity
showed
that
the
major
metabolite
consisted
of
3­
hydroxymethylsulfentrazone
(
1.26
to
2.55%
of
the
administered
dose).
The
proposed
metabolic
pathway
appeared
to
be
conversion
of
the
parent
compound
mainly
to
3­
hydroxymethylsulfentrazone
(
excreted
in
urine
and
feces).
7.
Endocrine
disruption.
An
evaluation
of
the
potential
effects
on
the
endocrine
systems
of
mammals
has
not
been
determined;
however,
no
evidence
of
such
effects
were
reported
in
the
chronic
or
reproductive
toxicology
studies
described
above.
There
was
no
observed
pathology
of
the
endocrine
organs
in
these
studies.
There
is
no
evidence
at
this
time
that
sulfentrazone
causes
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
A
Tier
3
short­
term
exposure
analysis
has
been
performed
to
estimate
the
exposure
for
all
adults,
adult
females,
and
toddlers
(
3
to
4
years
of
age)
in
the
U.
S.
population
for
these
raw
commodities
and
processed
commodities.
This
analysis
utilized
Novigen's
(
Novigen
Sciences,
Inc.)
Dietary
Exposure
Evaluation
Model
(
DEEM)
software;
field
trial
data
for
registered
and
pending
crop
uses;
percent
crop
treated
information;
and
consumption
data
from
the
United
States
Department
of
Agriculture
(
USDA)
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFIIs),
conducted
from
1994
 
1996.
ii.
Drinking
water.
A
Tier
1
short­
term
drinking
water
exposure
assessment
was
conducted
to
determine
exposure
risk
of
sulfentrazone
residues
from
consumption
of
water.
This
analysis
was
performed
utilizing
EPA's
Standard
Operating
Procedure
(
SOP)
for
Drinking
Water
Exposure
Risk
Assessments
(
DUS
EPA,
1997b),
the
absorbed
(
systemic)
aggregate
exposure
estimates,
and
water
data
from
FMC
Corporation
ground
water
study
conducted
in
North
Carolina.
2.
Non­
dietary
exposure.
The
primary
source
for
human
non­
dietary
exposure
to
sulfentrazone
will
be
from
postapplication
exposure
to
treated
residential
turf
grass.
The
routes
of
sulfentrazone
exposure
were
dermal
post­
application
exposure
for
adults
and
toddlers,
and
post­
application
incidental
ingestion
of
sulfentrazone
due
to
the
hand­
to­
mouth
behavior
of
toddlers.
A
worst
case
short­
term
nondietary
exposure
analysis
was
conducted
using
algorithms
and
default
factors
published
in
EPA's
SOPs
for
Residential
Exposure
Assessments.

D.
Cumulative
Effects
Cumulative
exposure
to
substances
with
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
considers
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide
residue
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
In
the
case
of
sulfentrazone,
EPA
has
determined
that
it
does
not
have
the
capability
to
apply
the
information
in
its
files
to
a
resolution
of
common
mechanism
issues
in
a
manner
that
would
be
useful
in
a
risk
assessment.
This
tolerance
determination
therefore
does
not
take
into
account
common
mechanism
issues.
The
Agency
will
reexamine
the
tolerances
for
sulfentrazone,
if
reexamination
is
appropriate,
after
the
Agency
has
determined
how
to
apply
common
mechanism
issues
to
its
pesticide
risk
assessments.

E.
Safety
Determination
1.
U.
S.
population.
The
absorbed
(
systemic)
aggregate
exposure
estimates
for
all
adults,
and
adult
females
were
found
to
be
0.0015
mg/
kg/
day
and
0.0017
mg/
kg/
day,
respectively.
The
acute
dietary
(
99.9%),
non­
dietary,
and
aggregate
margin
of
exposure
(
MOE)
for
all
adults
were
found
to
be
12,353,
7,571,
and
6,726
respectively.
The
acute
dietary
(
99.9%),
non­
dietary
and
aggregate
MOE
for
adult
females
were
22,857,
6,327,
and
5,717
respectively.
The
MOE
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
the
U.
S.
population
from
exposure
to
sulfentrazone.
2.
Infants
and
children.
The
absorbed
(
systemic)
aggregate
exposure
estimates
for
toddlers
were
found
to
be
0.0054
mg/
kg/
day.
The
acute
dietary
(
99.9%),
non­
dietary,
and
aggregate
MOE
for
toddlers
were
found
to
be
6,721,
2,048,
and
1,869
respectively.
The
MOE
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
infants
and
children
from
exposure
to
sulfentrazone.
The
calculated
drinking
water
levels
of
concern
for
all
adults,
and
adult
females
were
estimated
to
be
298
parts
per
billion
(
ppb),
250
ppb,
respectively.
These
values
exceed
the
maximum
water­
monitoring
residue
of
42
ppb
(
from
the
North
Carolina
study).
Therefore,
the
data
indicate
a
low
risk
potential
due
to
the
aggregate
(
food,
water
and
residential)
exposures
to
sulfentrazone
residues.

F.
International
Tolerances
There
are
no
Codex
Alimentarius
Commission
(
Codex)
maximum
residue
levels
for
sulfentrazone.
[
FR
Doc.
03
 
5319
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0350;
FRL
 
7285
 
8]

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
 
2002
 
0350,
must
be
received
on
or
before
April
7,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00070
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1
11101
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Mike
Mendelsohn,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8715;
e­
mail
address:
mendelsohn.
mike@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
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
(
ID)
number
OPP
 
2002
 
0350.
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
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
VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00071
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1
11102
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
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
 
2002
 
0350.
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
 
2002
 
0350.
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
 
2002
 
0350.
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
 
2002
 
0350.
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.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
February
28,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
Mycogen/
Dow
AgroSciences
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.

Mycogen/
Dow
AgroSciences
PP
0G6112
This
notice
of
filing
summarizes
information
submitted
and
cited
by
Mycogen/
Dow
AgroSciences
in
support
of
a
request
for
a
temporary
exemption
from
tolerance
residues
of
the
plantincorporated
protectant
Bacillus
thuringiensis
(
B.
t.
Cry34/
35Ab1
Insecticidal
Crystal
Protein
(
ICP),
and
the
genetic
material
necessary
for
its
production
in
corn
(
formerly
known
as
Bacillus
thuringiensis
(
B.
t.))
149B1
protein
and
the
genetic
material
necessary
for
its
production
in
corn).
The
Mycogen/
Dow
AgroSciences
and
Pioneer
Hi­
Bred
experimental
use
permits
associated
with
the
petition
are
68467
 
EUP
 
3,
68467
 
EUP
 
5,
68467
 
EUP
 
T,
68467
 
EUP
 
I,
29964
 
EUP
 
1,
29964
 
EUP
 
3,
29964
 
EUP
 
U,
and
29964
 
EUP
 
L.

A.
Petition
Summary
for
B.
t.
Cry34/
35Ab1
ICP
Uses
B.
t.
Cry34/
35Ab1
ICP
is
expressed
in
corn
plants
to
provide
protection
from
key
coleopteran
insect
pests
such
as
the
western
corn
rootworm.
B.
t.
Cry34/
35Ab1
transgenic
plants
are
derived
from
transformation
events
that
contain
the
insecticidal
genes
via
a
plasmid
insert.
The
B.
t.
Cry34/
35Ab1
ICP
poses
no
foreseeable
risks
to
non­
target
organisms
including
mammals,
birds,
fish,
beneficial
insects,
and
earthworms.
B.
t.
Cry34/
35Ab1­
protected
field
corn
provides
growers
with
a
highly
efficacious
tool
for
controlling
important
insect
pests
in
corn
in
a
manner
that
is
fully
compatible
with
integrated
pest
management
practices.

VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00072
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1
11103
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
B.
Product
Identity
and
Chemistry
The
Cry34Ab1
and
Cry35Ab1
genes
were
isolated
from
Bacillus
thuringiensis
strain
PS149B1
and
modified
before
insertion
into
corn
plants.
The
Cry34/
35Ab1
ICP
has
been
adequately
characterized.
Several
safety
studies
were
conducted
using
microbially
produced
test
substances
that
contained
54%
of
the
Cry34Ab1
(
14
kDa)
protein
and
37%
of
the
Cry35Ab1
(
44
kDa)
protein.
Studies
conducted
to
establish
the
equivalence
of
the
Cry34/
35Ab1
ICP
obtained
from
corn
or
from
a
microbial
source
demonstrate
that
the
materials
are
similar
with
respect
to
molecular
weight,
immunoreactivity,
lack
of
post­
translational
modification
(
glycosylation)
N­
terminal
amino
acid
sequence,
and
spectrum
of
bioactivity.
A
qualitative
analytical
method
(
lateral
flow
immunoassay)
for
the
detection
of
the
Cry34Ab1
(
14
kDa)
protein
has
been
submitted
(
MRID
#
45383401).

C.
Mammalian
Toxicity
Profile
Cry
proteins
have
been
deployed
as
safe
and
effective
pest
control
agents
in
microbial
Bacillus
thuringiensis
formulations
for
almost
40
years.
There
are
currently
180
registered
microbial
Bacillus
thuringiensis
products
in
the
United
States
for
use
in
agriculture,
forestry,
and
vector
control.
The
numerous
toxicology
studies
conducted
with
these
microbial
products
show
no
significant
adverse
effects,
and
demonstrate
that
the
products
are
practically
non­
toxic
to
mammals.
An
exemption
from
the
requirement
of
a
tolerance
has
been
in
place
for
these
products
since
at
least
1971
(
40
CFR
180.1011).
Toxicology
studies
conducted
to
determine
the
toxicity
of
Cry34/
35Ab1
ICP
demonstrated
that
the
proteins
have
very
low
toxicity.
The
acute
oral
LD50
of
Cry34Ab1
(
14
kDa)
is
greater
than
5,000
milligrams/
kilogram
(
mg/
kg),
and
at
54%
purity,
the
acute
LD50
for
pure
protein
is
greater
than
2,700
mg/
kg.
The
acute
oral
LD50
of
Cry35Ab1
(
44
kDa)
is
greater
than
5,000
mg/
kg,
and
at
37%
purity,
the
acute
LD50
for
pure
protein
is
greater
than
1,850
mg/
kg
in
male
mice
when
the
proteins
were
tested
individually.
When
tested
as
a
mixture
(
1:
3
molar
ratio
of
Cry34Ab1:
Cry35Ab1
proteins),
the
acute
oral
LD50
of
PS149B1
Cry34/
35Ab1
proteins
in
male
and
female
mice
is
greater
than
5,000
mg/
kg,
and
greater
than
2,000
mg/
kg
of
an
equimolar
(
1:
3)
mixture
of
pure
proteins.
In
in
vitro
studies,
Cry34/
35Ab1
ICP
exhibited
a
high
rate
of
digestibility
under
simulated
gastric
conditions
(
referred
to
as
SGF)
in
the
presence
of
pepsin.
The
Cry34Ab1(
14
kDa
protein)
was
greater
than
90%
digested
in
SGF
6.2
minutes.
The
Cry35Ab1
(
44
kDa
protein)
was
greater
than
97%
digested
in
less
than
5
minutes.
Also,
thermolability
testing
results
showed
that
the
ICP
was
deactivated
following
exposure
to
60
°
C,
75
°
C,
and
90
°
C
for
30
minutes.
A
search
of
relevant
data
bases
indicated
that
the
amino
acid
sequences
of
the
Cry34/
35Ab1
ICP
exhibit
no
significant
homology
to
the
sequences
of
known
protein
allergens.
Thus,
Cry34/
35Ab1
ICP
is
highly
unlikely
to
exhibit
an
allergic
response.
The
genetic
material
necessary
for
the
production
of
the
Cry34/
35Ab1
ICP
is
nucleic
acid
(
DNA)
which
is
common
to
all
forms
of
plant
and
animal
life.
There
are
no
known
instances
where
nucleic
acids
have
caused
toxic
effects
as
a
result
of
dietary
exposure.
Collectively,
the
available
data
on
Cry34/
35Ab1
ICP
along
with
the
safe
use
history
of
microbial
Bacillus
thuringiensis
products
establishes
the
safety
of
the
plant­
incorporated
protectant
B.
t.
Cry34/
35Ab1
ICP
and
the
genetic
material
necessary
for
its
production
in
all
raw
agricultural
commodities.

D.
Aggregate
Exposure
Because
B.
t.
Cry34/
35Ab1
ICP
is
expressed
in
minute
quantities
and
is
retained
within
the
plant,
there
is
virtually
no
potential
for
dermal
or
inhalation
exposure
to
the
protein.
Significant
dietary
exposure
to
Cry34/
35Ab1
ICP
is
unlikely
to
occur.
Dietary
exposures
at
very
low
levels,
via
ingestion
of
processed
commodities,
although,
they
may
occur,
are
unlikely
to
be
problematic
because
of
the
low
toxicity
and
the
high
degree
of
digestibility
of
the
protein.
In
addition,
the
protein
is
not
likely
to
be
present
in
drinking
water
because
the
protein
is
deployed
in
minute
quantities
within
the
plant,
and
studies
demonstrate
that
Cry34/
35Ab1
ICP
is
rapidly
degraded
in
soil.
In
summary,
the
potential
for
significant
aggregate
exposure
to
Cry34/
35Ab1
is
highly
unlikely.

E.
Cumulative
Exposure
Common
modes
of
toxicity
are
not
relevant
to
consideration
of
the
cumulative
exposure
to
B.
t.
Cry34/
35Ab1
ICP.
The
product
has
demonstrated
low
toxicity,
and
these
effects
do
not
appear
to
be
cumulative
with
any
other
known
compounds.

F.
Safety
Determination
1.
U.
S.
population.
The
deployment
of
the
product
in
minute
quantities
within
the
plant,
the
very
low
toxicity
of
the
product,
the
lack
of
allergenic
potential,
and
the
high
degree
of
digestibility
of
the
proteins,
are
all
factors
in
support
of
Mycogen/
Dow
AgroSciences'
assertion
that
no
significant
risk
is
posed
by
exposure
of
the
U.
S.
population
to
B.
t.
Cry34/
35Ab1
ICP.
2.
Infants
and
children.
Non­
dietary
exposure
to
infants
and
children
is
not
anticipated,
due
to
the
proposed
use
pattern
of
the
product.
Due
to
the
very
low
toxicity
of
the
product,
the
lack
of
allergenic
potential,
and
the
high
degree
of
digestibility
of
the
proteins,
dietary
exposure
is
anticipated
to
be
at
very
low
levels
and
is
not
anticipated
to
pose
any
harm
to
infants
and
children.

G.
Effects
on
the
Immune
and
Endocrine
System
Given
the
high
degree
of
digestibility
of
the
Cry34/
35Ab1
ICP,
no
chronic
effects
are
expected.
Cry34/
35Ab1
ICP,
or
metabolites
of
the
ICP
are
not
known
to,
or
are
expected
to
have
any
effect
on
the
immune
or
endocrine
systems.
Proteins
in
general
are
not
carcinogenic,
therefore,
no
carcinogenic
risk
is
associated
with
the
Cry34/
35Ab1
ICP.

H.
Existing
Tolerances
or
Exemptions
from
Tolerance
There
are
no
existing
tolerances
or
exemptions
from
tolerance
for
B.
t.
Cry34/
35Ab1
ICP.
[
FR
Doc.
03
 
5620
Filed
3
 
7
 
03;
2:
17
pm]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0016;
FRL
 
7289
 
3]

Experimental
Use
Permit;
Receipt
of
Application
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
receipt
of
an
application
68467
 
EUP
 
4
from
Mycogen
Seeds/
Dow
Agrosciences
LLC
requesting
an
experimental
use
permit
(
EUP)
amendment/
extension
for
Bacillus
thuringiensis
moCry1F
protein
and
the
genetic
material
necessary
for
its
production
(
plasmid
insert
PHP
12537)
in
corn.
The
Agency
has
determined
that
the
application
may
be
of
regional
and
national
significance.
Therefore,
in
accordance
with
40
CFR
172.11(
a),
the
Agency
is
soliciting
comments
on
this
application.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0016,
must
be
received
on
or
before
April
7,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
VerDate
Jan<
31>
2003
20:
00
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00073
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1