Document ID: EPA-HQ-OPP-2003-0164-0001
Agency: epa
Document Type: Notice
Title: Bacillus Thuringiensis VIP3A Insect Control Protein; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-06-06T04:00Z

33942
Federal
Register
/
Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Notices
4.
Identifying
activities
that
resulted
in
the
improvement
of
the
community's
environmental
and/
or
public
health
concerns;.
5.
Stating
how
funding
resources
were
committed;
and,
6.
Identifying
any
issues/
problems
encountered
and
the
methods
for
resolution.
B.
Monthly
Conference
Calls
 
Moreover,
the
grantee
will
confer
on
a
monthly
basis
with
the
OEJ
staff
person
identified
as
the
technical
contact.
A
template
will
be
furnished
on
those
items
to
be
discussed.
In
general,
every
call
and
report
will
follow
the
evaluation
criteria
described
in
section
IV.
C.
Development
of
Performance
Measures
for
Grant
 
As
a
condition
to
receiving
Environmental
Justice
CPS
grants,
grantees
are
required
to
develop
measurable
outcomes
to
be
achieved
through
the
activities
for
which
these
grant
funds
were
awarded.
The
performance
measures
(
evaluation
criteria)
should
focus
on
solid,
qualitative
activities
related
to
the
grantee's
activities,
outputs,
and
outcomes.
These
performance
measures
will
help
gather
insights
concerning
successful
implementation
strategies
and
generate
lessons
learned
that
may
be
applicable
to
future
projects
under
this
grant
program.
The
success
of
this
grant
program
will
be
entirely
dependent
on
the
work
of
the
grantees.
Therefore,
EPA
and
the
grantee
will
examine
whether,
as
a
result
of
the
grantee's
activities
and
outputs,
there
has
been:
 
Better
overall
environmental
and/
or
public
health
protection
for
community
residents;
 
Significant
improvement
in
the
quality­
of­
life
of
community
residents;
 
Significant
increase
in
the
community's
capacity
as
it
relates
to
understanding
the
environmental
and/
or
public
health
issues
affecting
the
community;
a
better
understanding
of
the
permitting
processes;
a
better
understanding
of
the
use
of
environmental
laws
and
their
implementing
regulations
to
address
environmental
justice
concerns;
and
a
better
understanding
of
alternative
dispute
resolution
and
negotiation
techniques;
 
Effective
use
of
the
collaborative
problem­
solving
processes;
 
Transferability
of
the
lessons
learned
to
other
communities
similarly
situated;
and,
 
Effective
community
revitalization.
D.
Final
Report
Requirement
 
All
grant
recipients
must
submit
a
Final
Technical
Report
for
EPA
approval
within
ninety
(
90)
days
of
the
end
of
the
project
period.
A
draft
of
this
report
should
be
submitted
within
60
days
of
the
end
of
the
project
period.
A
Financial
Status
Report
is
also
required
and
is
described
in
the
award
agreement
document.
The
EPA
will
collect,
review,
and
disseminate
those
final
reports
which
can
serve
as
models
for
future
projects.
E.
Change
in
Project
Requiring
Project
Officer
Approval
 
The
grant
recipient
is
responsible
for
the
successful
completion
of
the
project.
However,
any
change
in
the
Project
Manager
or
Principal
Investigator
is
subject
to
approval
by
the
EPA
Project
Officer.
You
must
immediately
submit
the
reason
for
the
change
and
the
qualifications
of
the
new
Project
Manager
or
Principal
Investigator
to
the
Project
Officer
in
writing.
This
can
be
sent
by
e­
mail
to
smith.
linda@
epa.
gov
or
by
fax
to
(
202)
501
 
1162.
For
further
information
about
this
Environmental
Justice
CPS
grant
program,
please
visit
the
EPA's
Web
site
at:
http://
www.
epa.
gov/
compliance/
environmentaljustice/
grants/
index.
html
or
call
our
hotline
at
1
 
800
 
962
 
6215
(
available
in
Spanish).

Dated:
May
30,
2003.
Barry
E.
Hill,
Director,
Office
of
Environmental
Justice.
[
FR
Doc.
03
 
14324
Filed
6
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0164;
FRL
 
7306
 
5]

Bacillus
Thuringiensis
VIP3A
Insect
Control
Protein;
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
 
0164,
must
be
received
on
or
before
July
7,
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:
Leonard
Cole,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5412;
e­
mail
address:
cole.
leonard@
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
productiom
(
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
 
0164.
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
are
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
VerDate
Jan<
31>
2003
15:
26
Jun
05,
2003
Jkt
200001
PO
00000
Frm
00040
Fmt
4703
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4703
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FR\
FM\
06JNN1.
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06JNN1
33943
Federal
Register
/
Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Notices
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.
1.
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
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
 
0164.
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
 
0164.
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
 
0164.
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
 
0164.
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
VerDate
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Federal
Register
/
Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Notices
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:
May
29,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
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
the
Syngenta
Seeds,
Inc.
petitioner
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.

Syngenta
Seeds,
Inc.

PP
3G6547
EPA
has
received
a
pesticide
petition
(
PP
3G6547)
from
Syngenta
Seeds,
Inc.,
P.
O.
Box
12257,
3054
Cornwallis
Road,
Research
Triangle
Park,
NC
27709
 
2257,
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
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
pesticide
Bacillus
thuringiensis
VIP3A
insect
control
protein,
as
expressed
in
event
COT102,
and
the
genetic
material
necessary
for
its
production
in
or
on
cotton.
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Syngenta
Seeds,
Inc.
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Syngenta
Seeds,
Inc.,
and
EPA
has
not
fully
evaluated
the
merits
of
the
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.

A.
Product
Name
and
Proposed
Use
Practices
Syngenta
has
developed
a
new
cotton
line
that
expresses
an
insect
control
protein
designated
VIP3A.
It
has
been
genetically
incorporated
into
a
cotton
plant
product
identified
as
Bacillus
thuringiensis
(
Bt)
VIP3A
insect
control
protein
as
expressed
in
event
COT102.
VIP3A
is
one
of
a
novel
class
of
recently
discovered
insecticidal
proteins
that
occur
naturally
in
Bacillus
thuringiensis.
The
VIPs
(
vegetative
insecticidal
proteins)
are
produced
during
vegetative
bacterial
growth.
Other
than
its
demonstrated
insecticidal
activity,
VIP3A
is
not
known
to
have
any
other
biological
or
catalytic
function.
Although,
VIP3A
protein
shares
no
homology
with
known
Cry
proteins,
extensive
testing
has
established
that
VIP3A
is
similarly
very
specific
in
its
activity,
and
has
demonstrated
toxicity
only
to
the
larvae
of
certain
lepidopteran
species,
including
key
pests
of
cotton.
Further,
because
VIP3A
appears
to
target
a
different
receptor
than
Cry
proteins
in
sensitive
species,
it
represents
a
potentially
useful
tool
in
the
prevention
or
management
of
pest
resistance
to
Cry
proteins.
Upon
commercial
introduction,
the
use
of
transgenic
VIP3A
cotton
plants
is
expected
to
offer
an
important
new
option
in
lepidopteran
pest
control
and
integrated
pest
management
programs.
Moreover,
VIP3A
cotton
will
be
an
attractive,
biologically
based
alternative
to
the
use
of
foliar
insecticides.
The
use
of
VIP3A
cotton
plants
is
expected
to
offer
substantial
environmental
and
worker
safety
benefits
associated
with
the
reduced
need
for
broad­
spectrum
insecticides.
Additionally,
benefits
to
cotton
growers
will
likely
include
greater
profitability,
convenience
and
predictability
in
producing
a
highyielding
cotton
crop.
VIP3A­
expressing
cotton
plants
derived
from
transformation
event
COT102
have
been
field
tested
under
U.
S.
Department
of
Agriculture
(
USDA)
notifications
and
in
compliance
with
the
guidelines
for
USDA­
regulated
plantings
in
2000,
2001,
and
2002.
The
overall
results
of
those
trials
have
indicated
that
cotton
plants
derived
from
event
COT102
have
significant
and
specific
insecticidal
activity
against
several
lepidopteran
pests
including,
but
not
limited
to,
Helicoverpa
zea
(
cotton
bollworm),
Heliothis
virescens
(
tobacco
budworm),
and
Pectinophora
gossypiella
(
pink
bollworm)

B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
Cotton,
Gossypium
hirsutum,
has
been
genetically
modified
to
be
resistant
to
selected
lepidopteran
insect
pests.
Insect
protection
was
accomplished
by
the
insertion
of
the
VIP3A(
a)
gene,
which
was
cloned
from
Bacillus
thuringiensis
strain
AB88.
The
identity
of
the
active
pesticidal
ingredient
in
cotton
plants
derived
from
transformation
event
COT102
includes
the
protein
VIP3A
and
the
genetic
material
necessary
for
its
production
in
cotton.
Research
has
demonstrated
the
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specific
insecticidal
properties
of
VIP3A
to
certain
lepidopteran
insects
in
cotton
as
well
as
its
lack
of
effects
on
nontarget
organisms
such
as
mammals,
birds,
fish,
and
beneficial
insects.
2.
Magnitude
of
residue.
A
determination
of
the
magnitude
of
residue
at
harvest
is
not
required
for
residues
exempt
from
tolerances.
However,
the
petitioner
has
provided
data
on
the
quantity
of
VIP3A
protein
measured
in
various
plant
parts
including
seeds
of
VIP3A
cotton,
as
measured
by
enzyme
linked
immunosorbent
assay
(
ELISA).
Additionally,
the
petitioner
has
provided
data
on
the
quantity
or
presence
of
VIP3A
protein
in
processed
cottonseed
products.
3.
A
statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
An
analytical
method
is
not
required
because
this
petition
requests
an
exemption
from
tolerances.
However,
the
petitioner
has
submitted
an
analytical
method
for
detection
of
the
VIP3A
protein
in
cottonseed
by
ELISA
analysis.

C.
Mammalian
Toxicological
Profile
The
VIP3A(
a)
gene
expressed
in
event
COT102
cotton
is
very
similar
(
ca.
99%
homology)
to
VIP3A
or
VIP3A­­
like
genes
that
appear
to
occur
commonly
in
Bt
strains
from
a
variety
of
sources.
In
addition,
it
has
been
determined
that
the
VIP3A
protein
demonstrates
insect
specific
toxicity
and
must
be
ingested
to
be
active.
Once
in
the
insect
gut,
the
VIP3A
protein
binds
to
specific
receptors
(
different
from
those
bound
by
Cry1A
proteins),
inserts
into
the
membrane
and
forms
ion­
specific
pores.
These
events
disrupt
the
digestive
processes
and
cause
death
of
the
insect.
The
lack
of
mammalian
toxicity
has
been
confirmed
in
numerous
safety
studies
conducted
in
laboratory
animals,
which
are
traditional
experimental
surrogates
for
humans.
These
studies,
summarized
herein,
demonstrate
the
lack
of
toxicity
of
the
VIP3A
protein
following
high­
dose
acute
oral
exposures
to
mice,
rapid
degradation
of
VIP3A
upon
exposure
to
simulated
gastric
fluid,
and
the
lack
of
amino
acid
sequence
similarity
of
the
VIP3A
protein
to
proteins
known
to
be
mammalian
toxins
or
human
allergens.
It
can
be
concluded
from
these
studies
that
the
VIP3A
protein
will
be
non­
toxic
to
humans.
When
proteins
are
toxic,
they
are
known
to
act
via
acute
mechanisms
and
at
very
low
doses
(
Ref.
1).
Therefore,
when
a
protein
demonstrates
no
acute
oral
toxicity
in
high­
dose
testing
using
a
standard
laboratory
mammalian
test
species,
this
supports
the
determination
that
the
protein
will
be
non­
toxic
to
humans
and
other
mammals,
and
will
not
present
a
hazard
under
any
realistic
exposure
scenario,
including
long­
term
exposures.
Studies
conducted
to
assess
the
mammalian
safety
of
VIP3A
protein
have
demonstrated
no
toxicity.
Four
acute
oral
toxicity
studies
in
mice
have
been
completed.
Three
of
the
VIP3A
test
substances
used
were
produced
via
microbial
expression
systems
and
one
prepared
by
extracting
protein
from
leaves
of
VIP3A
event
Pacha­
derived
corn
plants.
The
four
test
substances
contained
VIP3A
protein
that
differed
from
the
VIP3A
protein
expressed
in
event
COT102
by
zero
to
two
amino
acids.
At
maximum
dosage
the
microbially
expressed
test
substance
was
administered
at
a
level
of
5,000
milligrams/
kilogram
(
mg/
kg)
with
an
estimated
acute
lethal
dose
(
LD)
50
by
gavage
determined
to
be
>
3,675
mg
VIP3A/
kg
mg/
kg/
bwt/
wt.
Because
toxicity
was
not
observed
at
this
dose,
it
can
be
concluded
that
the
LD50
for
pure
VIP3A
protein
is
>
3,675
mg/
kg
body
weight.
The
VIP3A
protein
in
both
the
microbial
and
plant
derived
test
substance
was
determined
to
be
substantially
equivalent
to
VIP3A
produced
in
event
COT102
derived
cotton
plants,
as
measured
by
biological
activity,
protein
size,
immunreactivity,
mass
spectral
analysis
of
amino
acid
sequence,
and
apparent
lack
of
posttranslational
modifications.
The
amino
acid
sequence
of
VIP3A
is
not
homologous
to
that
of
any
known
or
putative
allergens
described
in
public
data
bases.
The
VIP3A
protein
is
not
derived
from
a
known
source
of
allergens
and
does
not
display
characteristics
commonly
associated
with
allergens,
including
glycosylation
or
stability
to
heat
and
food
processing.
Additionally,
VIP3A
is
susceptible
to
gastric
digestion
by
pepsin
and
did
not
provoke
an
allergic
response
in
an
experimental
atopic
dog
model
of
human
food
allergy.
VIP3A
protein
appears
to
be
present
in
multiple
commercial
formulations
of
Bacillus
thuringiensis
microbial
insecticides
at
concentrations
estimated
to
be
ca.
0.4
32
parts
per
million
(
ppm).
This
conclusion
is
based
on
the
presence
of
proteins
of
the
appropriate
molecular
weight
and
immunoreactivity
(
by
SDS­
PAGE
and
western
blot),
and
quantitation
by
ELISA.
Therefore,
it
is
conceivable
that
small
quantities
of
VIP3A
protein
are
present
in
the
food
supply
because
VIP3A
or
a
very
similar
protein,
based
on
size
and
immunoreactivity
appears
to
be
present
in
currently
registered
insecticide
products
used
on
food
crops,
including
fresh
market
produce.
These
commercial
Bacillus
thuringiensis
products
are
all
exempt
from
food
and
feed
tolerances.

D.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Food
products
derived
from
cotton
(
refined
cottonseed
oil
and
cellulose
linters
fiber)
are
highly
processed
and
are
essentially
devoid
of
any
proteins.
Moreover,
no
VIP3A
protein
was
detected
in
refined
cottonseed
oil
or
cotton
fiber
produced
from
event
COT102­
derived
VIP3A
cotton
plants.
Therefore,
no
human
dietary
exposure
to
VIP3A
protein
is
expected
to
occur
via
VIP3A
cotton.
Even
if
dietary
exposure
to
VIP3A
protein
were
to
occur,
data
derived
from
bioinformatic
analyses
as
well
as
direct
in
vitro
and
in
vivo
testing
collectively
indicate
that
the
VIP3A
protein
is
unlikely
to
have
allergenic
potential.
The
amino
acid
sequence
of
VIP3A
is
not
homologous
to
that
of
any
known
or
putative
allergens
described
in
public
data
bases.
The
VIP3A
protein
is
not
derived
from
a
known
source
of
allergens
and
does
not
display
characteristics
commonly
associated
with
allergens,
including
glycosylation
or
stability
to
heat
and
food
processing.
Additionally,
VIP3A
is
susceptible
to
gastric
digestion
by
pepsin
and
did
not
provoke
an
allergic
response
in
an
experimental
atopic
dog
model
of
human
food
allergy.
ii.
Drinking
water.
No
exposure
to
VIP3A
and
the
genetic
material
necessary
for
its
production
in
cotton
via
drinking
water
is
expected.
The
proteins
are
incorporated
into
the
plant
and
will
not
be
available.
However,
if
exposure
were
to
occur
by
this
route,
no
risk
would
be
expected
because
the
VIP3A
protein
is
not
toxic
to
mammals.
2.
Non­
dietary
exposure.
Non­
dietary
exposure
is
not
anticipated,
due
to
the
proposed
use
pattern
of
the
product.
Exposure
via
dermal
or
inhalation
routes
is
unlikely
because
the
plantincorporated
protectant
is
contained
within
plant
cells.
However,
if
exposure
were
to
occur
by
non­
dietary
routes,
no
risk
would
be
expected
because
the
VIP3A
protein
is
not
toxic
to
mammals.

E.
Cumulative
Exposure
Because
there
is
no
indication
of
mammalian
toxicity
to
the
VIP3A
protein,
it
is
reasonable
to
conclude
that
there
are
no
cumulative
effects
for
this
plant­
incorporated
protectant.

F.
Safety
Determination
1.
U.
S.
population.
The
lack
of
mammalian
toxicity
at
high
levels
of
exposure
to
the
VIP3A
protein
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demonstrates
the
safety
of
the
product
at
levels
well
above
possible
maximum
exposure
levels
anticipated
via
consumption
of
processed
food
products
produced
from
VIP3A
cotton.
Moreover,
little
to
no
human
dietary
exposure
to
VIP3A
protein
is
expected
to
occur
via
VIP3A
cotton.
Due
to
the
lack
of
toxicity
of
the
VIP3A
protein
and
its
very
low
potential
for
allergenicity,
dietary
exposure
is
not
anticipated
to
pose
any
harm
for
the
U.
S.
population.
No
special
safety
provisions
are
applicable
for
consumption
patterns
or
for
any
population
sub­
groups.
2.
Infants
and
children.
The
plantincorporated
protectant
active
ingredient,
Bacillus
thuringiensis
VIP3A
insect
control
protein
and
the
genetic
material
necessary
for
its
production
in
cotton,
demonstrates
no
mammalian
toxicity.
Thus,
there
are
no
threshold
effects
of
concern
and,
consequently,
there
is
no
need
to
apply
an
additional
margin
of
safety.

G.
Effects
on
the
Immune
and
Endocrine
Systems
The
safety
data
submitted
show
no
adverse
effects
in
mammals,
even
at
very
high
dose
levels,
and
support
the
prediction
that
the
VIP3A
protein
would
be
non­
toxic
to
humans.
Therefore,
no
effects
on
the
immune
or
endocrine
systems
are
predicted.
When
proteins
are
toxic,
they
are
known
to
act
via
acute
mechanisms
and
at
very
low
dose
levels
(
Ref.
1).
Further,
the
VIP3A
protein
is
derived
from
a
source
that
is
not
known
to
exert
an
influence
on
the
endocrine
system.

H.
Existing
Tolerances
There
are
no
existing
tolerances
for
the
Bacillus
thuringiensis
VIP3A
protein
and
the
genetic
material
necessary
for
its
production.
Other
Bacillus
thuringiensis
based
pesticide
products
are
exempt
from
tolerances.

I.
International
Tolerances
There
are
no
existing
international
tolerances
or
exemptions
from
tolerance
for
the
Bacillus
thuringiensis
VIP3A
protein
and
the
genetic
material
necessary
for
its
production.

J.
Reference
1.
Sjoblad,
R.
D.,
J.
T.
McClintock
and
R.
Engler,
(
1992)
Toxicological
Consideration
for
Protein
Components
of
Biological
Pesticide
Products.
Regulatory
toxicol
Pharmacol
15:
3­
9
[
FR
Doc.
03
 
14199
Filed
6
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OA
 
2003
 
0005:
FRL
 
7508
 
7]

Public
Involvement
Policy
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
New
Public
Involvement
Policy.

SUMMARY:
The
EPA
is
issuing
its
new
Public
Involvement
Policy.
The
purpose
of
today's
Notice
is
to
advise
the
public
and
present
the
Policy.
The
new
Policy
provides
guidance
to
EPA
staff
on
effective
and
reasonable
means
to
involve
the
public
in
EPA's
regulatory
and
program
implementation
decisions.
The
core
of
the
Policy
is
the
recommended
seven
basic
steps
for
effective
public
involvement,
which
the
Agency
should
consider
when
making
major
decisions
on
rules,
policies
and
program
implementation
activities.
The
Policy
is
directed
internally,
but
EPA's
partners
in
states,
tribes
or
local
governments
may
also
find
it
to
be
a
useful
tool
for
them.

FOR
FURTHER
INFORMATION
CONTACT:
Patricia
Bonner,
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460
 
0001;
202
 
566
 
2204;
bonner.
patricia@
epa.
gov.
For
printed
copies,
telephone
202
 
566
 
2216.

SUPPLEMENTARY
INFORMATION:
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
OA
 
2003
 
0005.
The
official
public
docket
consists
of
the
complete
Public
Involvement
Policy
with
its
appendices
and
addenda,
public
comments
on
the
1981
and
draft
2000
Policy,
the
Agency's
Response
to
Comments
and
the
Framework
for
Implementing
EPA's
Public
Involvement
Policy.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Office
of
Environmental
Information
Docket,
EPA
Docket
Center,
(
EPA/
DC)
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566
 
1744.
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/
or
use
http://
www.
epa.
gov/
publicinvolvement
to
access
the
Policy
and
all
its
attachments.
Electronic
versions
of
items
in
the
public
docket
are
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets
(
EDOCKET).
You
may
use
EDOCKET
at
http://
www.
epa.
gov/
edocket/
to
access
the
index
listing
of
the
contents
of
the
official
public
docket
and
documents
that
are
available
electronically.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
You
may
still
access
any
of
the
publicly
available
docket
materials
through
the
EPA
Docket
Center.

Background
On
January
19,
1981,
the
Environmental
Protection
Agency
(
EPA)
published
its
first
Agency­
wide
Public
Participation
Policy
(
46
FR
5736,
Jan.
19,
1981).
In
November
1999,
the
EPA
requested
public
comment
on
whether
and
how
to
change
that
Policy,
and
subsequently
began
a
process
to
revise
the
policy
and
create
a
plan
to
implement
it
across
the
Agency.
In
December
2000,
EPA
released
a
draft
revised
Public
Involvement
Policy
for
public
comment
(
65
FR
82335,
Dec.
28,
2000).
The
comment
period
closed
on
July
31,
2001,
following
a
two­
week
internet­
based
dialogue
on
``
Public
Involvement
in
EPA
Decisions,''
which
included
1,144
participants
from
all
50
states.

Overview
of
EPA's
New
Public
Involvement
Policy
The
Policy's
core
elements
are
the
following
seven
basic
steps
for
effective
public
involvement:
1.
Plan
and
budget
for
public
involvement
activities.
2.
Identify
the
interested
and
affected
public.
3.
Consider
providing
technical
or
financial
assistance
to
the
public
to
facilitate
involvement.
4.
Provide
information
and
outreach
to
the
public.
5.
Conduct
public
consultation
and
involvement
activities.
6.
Review
and
use
input,
and
provide
feedback
to
the
public.
7.
Evaluate
public
involvement
activities.
This
Policy
is
meant
to
encourage
development
of
new
tools
for
public
involvement
and
should
not
limit
the
degree
or
types
of
public
involvement
already
in
use
at
EPA.
Agency
guidance,
which
EPA
is
issuing
simultaneously
with
this
Policy,
provides
specific
recommendations
for
accomplishing
each
of
these
seven
steps,
while
also
acknowledging
the
need
for
EPA
officials
to
use
discretion
when
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