Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
BIOPESTICIDES
REGISTRATION
ACTION
DOCUMENT
Bacillus
thuringiensis
(
Bt)
Plant­
Incorporated
Protectants
This
version
of
the
Biopesticides
Registration
Action
Document
for
the
Bacillus
thuringiensis
(
Bt)
Plant­
Incorporated
Protectants
is
dated
October
15,
2001.
This
version
corresponds
to
the
version
issued
on
September
29,
2001,
with
the
following
changes.
The
Agency
has
revised
portions
of
Section
I.
Overview
and
Section
II.
Science
Assessment
relating
to
Cry1Ab
and
Cry1F
proteins
expressed
in
corn
(
Bt
corn),
in
light
of
public
comments
received
as
of
September
21,
2001.
The
Agency
has
also
added
two
new
sections
entitled:
"
V.
Bt
Corn
Confirmatory
Data
and
Terms
and
Conditions
of
Amended
Registration"
and
"
VI.
Regulatory
Position
on
Bt
Corn."

U.
S.
Environmental
Protection
Agency
Office
of
Pesticide
Programs
Biopesticides
and
Pollution
Prevention
Division
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
i
Table
of
Contents
I.
Overview
.....................................................................................................................
I1
A.
Executive
Summary
B.
Corn
C.
Cotton
D.
Potatoes
E.
Bt
Plant­
incorporated
protectants
Use,
Registration
Approval
History,
and
Tolerance
Listing
.

II.
Science
Assessment
.....................................................................................................
IIA1
A.
Product
Characterization
........................................................................................
IIA1
1.
Corn
2.
Cotton
3.
Potatoes
B.
Human
Health
Assessment
......................................................................................
IIB1
1.
Cry1Ab
Corn
2.
Cry1Ac
Cotton
3.
Cry3A
Potato
C.
Environmental
Assessment
......................................................................................
IIC1
1.
Gene
Flow
and
Weediness
2.
Horizontal
Transfer
of
Transgenes
from
Bt
Crops
to
Soil
Organisms
3.
Ecological
Exposure
4.
Ecological
Effects
Testing
5.
Environmental
Reassessment
Summary
D.
Insect
Resistance
Management
.................................................................................
IID1
E.
Benefits
.....................................................................................................................
IIE1
III.
Bt
Cotton
Confirmatory
Data
and
Terms
and
Conditions
of
the
Amendment
........
III1
IV.
Regulatory
Position
on
Bt
Cotton
.................................................................................
IV1
V.
Bt
Corn
Confirmatory
Data
and
Terms
and
Conditions
of
the
Amendment
............
V1
VI.
Regulatory
Position
on
Bt
Corn
....................................................................................
VI1
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
ii
BACILLUS
THURINGIENSIS
PLANT­
INCORPORATED
PROTECTANTS
REGISTRATION
ACTION
TEAM
Benefits
Assessment
Edward
Brandt,
M.
A.
Robert
Torla,
Ph.
D.
Felicia
Wu
Morris,
M.
A.,
M.
S.

Environmental
Fate
and
Effects
Risk
Assessment
Zigfridas
Vaituzis,
Ph.
D.
Chris
Wozniak,
Ph.
D.
Robyn
Rose,
M.
S.
Gail
Tomimatsu,
Ph.
D.

Health
Effects
Risk
Assessment
John
Kough,
Ph.
D.
Michael
T.
Watson,
Ph.
D.

Insect
Resistance
Management
Assessment
Sharlene
Matten,
Ph.
D.
Alan
Reynolds,
M.
S.
Robyn
Rose,
M.
S.

Registration
Support
Willie
Nelson,
M.
S.
Mike
Mendelsohn
Communications
Support
Brian
Steinwand
Toby
Tiktinski
Biopesticides
Registration
Action
Document
Team
Leader
Mike
Mendelsohn
Office
of
Pesticide
Programs
William
Jordan
Office
of
General
Counsel
Keith
A.
Matthews
Suzanne
Krolikowski
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I1
I.
Overview
This
version
of
the
Biopesticides
Registration
Action
Document
for
the
Bacillus
thuringiensis
(
Bt)
Plant­
Incorporated
Protectants
is
dated
October
15,
2001.
This
version
corresponds
to
the
version
issued
on
September
29,
2001,
with
the
following
changes.
The
Agency
has
revised
portions
of
Section
I.
Overview
and
Section
II.
Science
Assessment
relating
to
Cry1Ab
and
Cry1F
proteins
expressed
in
corn
(
Bt
corn),
in
light
of
public
comments
received
as
of
September
21,
2001.
The
Agency
has
also
added
two
new
sections
entitled:
"
V.
Bt
Corn
Confirmatory
Data
and
Terms
and
Conditions
of
Amended
Registration"
and
"
VI.
Regulatory
Position
on
Bt
Corn."

Syngenta
Seeds,
Inc.
(
formerly
Novartis
Seeds,
Inc.)
and
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC
came
to
the
Agency
indicating
that
as
part
of
their
business
plans
they
would
be
phasing
out
their
Event
176
corn
products.
Syngenta
Seeds
and
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC
Event
176
Cry1Ab
corn
registrations
expired
on
April
1,
2001
and
on
June
30,
2001,
respectively.
Existing
stocks
for
these
products
must
be
used
before
or
during
the
2003
growing
season.
EPA
has
determined
that
allowing
use
of
existing
stocks
for
Event
176
Bt
corn
products
through
the
2003
growing
season
will
not
result
in
unreasonable
adverse
effects
on
the
environment
and
the
plantincorporated
protectants
will
be
gone
from
the
environment
long
before
resistance
would
have
been
predicted
to
develop.
Both
former
registrants
have
agreed
to
comply
with
any
increased
IRM
requirements
that
may
result
from
this
reassessment
for
any
existing
stocks.

Aventis
requested
voluntary
cancellation
of
their
Cry9C
StarLink
corn
registration
and
this
cancellation
became
effective
on
February
20,
2001.

The
Event
176
and
Cry9C
products
are
not
being
considered
for
extensions.
They
will
generally
not
be
discussed
in
this
reassessment
document.

No
regulatory
changes
are
being
required
for
Bt
potato
products.

A.
Executive
Summary
EPA
has
completed
a
comprehensive
reassessment
of
the
time­
limited
registrations
for
all
existing
Bt
corn
and
cotton
plant­
incorporated
protectants.
As
part
of
EPA's
reassessment,
the
Agency
has
decided
to
extend
the
registrations
with
additional
terms
and
conditions
for
the
Bt
corn
and
cotton
plant­
incorporated
protectants
including
requiring
confirmatory
data
to
ensure
protection
of
non­
target
organisms
and
lack
of
accumulation
of
Bt
proteins
in
soils,
measures
to
limit
gene
flow
from
Bt
cotton
to
wild
(
or
weedy)
relatives,
and
a
strengthened
IRM
program,
especially
related
to
compliance.
Although
the
Bt
potato
product
does
not
have
an
expiring
registration,
EPA
has
also
included
information
on
this
plant­
incorporated
protectant
in
Section
II.
Science
Assessment
section
of
the
document.
This
reassessment
has
been
designed
to
assure
that
the
decisions
on
the
renewal
of
these
registrations
are
based
on
the
most
current
health
and
ecological
data.
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I2
The
Bt
cotton
comprehensive
reassessment
has
been
completed
and
the
Bt
cotton
registration
is
now
set
to
automatically
expire
on
September
30,
2006
except
for
the
external,
unsprayed
refuge
option
which
will
expire
September
30,
2004.

The
Bt
corn
comprehensive
reassessment
has
been
completed
and
the
Bt
corn
registrations
are
now
set
to
automatically
expire
on
October
15,
2008.

During
this
reassessment,
EPA
has
conducted
an
open
and
transparent
public
process
that
incorporated
sound
and
current
science,
and
substantial
public
involvement.

The
complete
reassessment
document
is
fashioned
after
the
Agency's
traditional
Reregistration
Eligibility
Document
(
RED).
This
format
was
selected
to
present
the
data
and
findings
in
a
format
that
is
familiar
to
the
registrants,
the
users
and
the
general
public.
The
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
has
nine
major
sections:

1.
Product
Characterization
2.
Human
Health
Assessment
3.
Ecological
Assessment
4.
Insect
Resistance
Management
5.
Benefits.
6.
Bt
Cotton
Confirmatory
Data
and
Terms
and
Conditions
of
the
Amendment
7.
Regulatory
Position
on
Bt
Cotton.
8.
Bt
Corn
Confirmatory
Data
and
Terms
and
Conditions
of
the
Amendment
9.
Regulatory
Position
on
Bt
Corn.

1.
Product
Characterization
and
Human
Health
Assessment
This
section
provides
information
on
the
specific
transformation
systems
that
were
used
for
each
product,
the
characterization
of
the
DNA
insert,
the
inheritance
and
stability
characteristics
of
the
product
line,
and
the
protein
characterization
and
levels
of
Bt
protein
expression
for
the
various
plant
tissues.
Specific
information
and
data
for
each
of
the
registrations
seeking
renewal
are
included
in
tabular
and
descriptive
formats.

The
health
effects
assessment
confirms
EPA's
original
findings
that
there
are
no
unreasonable
adverse
health
effects
from
these
products.
The
human
health
assessment
for
the
Bt
plant­
incorporated
protectants
draws
heavily
on
the
science
and
toxicology
of
proteins.
All
the
currently
registered
Bt
plant­
incorporated
protectants
are
proteins.
The
source
bacterium
has
been
a
registered
microbial
pesticide
which
has
been
approved
for
use
on
food
crops.
The
Bt
proteins
approved
for
use
in
food
are
expected
to
behave
as
would
be
expected
of
a
dietary
protein.
The
Bt
microbial
pesticides
have
a
long
history
of
safe
use
without
adverse
health
or
environmental
effects.
Several
types
of
data
are
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I3
required
for
the
Bt
plant­
incorporated
protectants
in
order
for
the
Agency
to
make
the
"
reasonable
certainty
of
no
harm"
finding
that
is
required
by
the
Federal
Food,
Drug,
and
Cosmetic
Act.
The
data
are
evaluated
in
order
to
determine
that
(
1)
the
protein
behaves
as
would
be
expected
of
a
dietary
protein
breaking
down
rapidly
in
digestive
fluids;
(
2)
the
protein
is
not
structurally
related
to
any
known
food
allergen
or
protein
toxin;
and
(
3)
the
protein
does
not
display
any
oral
toxicity
when
administered
at
high
doses.
In
this
section
of
the
assessment,
product
specific
data
are
addressed
for
each
of
the
following
areas:
in
vitro
digestion
assay,
heat
stability
and
amino
acid
sequence
homology
comparisons,
and
acute
oral
toxicity,
including
mutagenicity
and
developmental
toxicity,
subchronic
toxicity
and
chronic
exposure
and
oncogenicity.
Product
specific
information
is
also
addressed
for
immune
system
effects,
endocrine
effects,
dose
response
and
dietary
risk
characterizations.
The
rationale
is
presented
for
why
any
dietary
protein,
including
the
Bt
proteins,
would
not
be
expected
to
raise
concerns
for
subchronic
and
chronic
effects
such
as
mutagenicity,
oncogenicity
and
developmental
toxicity.
A
discussion
of
immune
system
effects,
endocrine
effects
and
dietary
and
non­
dietary
risk
characterization
is
included
for
each
product
as
would
be
found
in
any
assessment
for
a
pesticide
chemical's
food
tolerance
determination
since
implementation
of
the
FQPA
amendments
to
the
FFDCA.

This
document
will
also
serve
as
EPA's
review
of
the
associated
tolerance
exemptions
(
i.
e.,
tolerance
exemption
reassessments)
under
408(
q)
of
the
FFDCA.
By
this
reassessment,
EPA
has
completed
its
tolerance
reassessment
for
Cry1Ab
(
180.1173)
and
for
Cry3A
(
180.1147).
The
tolerance
exemptions
for
Cry1Ac
(
180.1155)
and
Cry1F
(
180.1217)
do
not
require
reassessment
at
this
time.

Since
the
September
2000
version
of
the
risk
and
benefits
assessments
and
the
October
2000
SAP
meeting,
these
sections
have
been
updated
by
indicating
additional
data
which
might
be
needed.
Product
characterization
data
supporting
currently
registered
products
is
adequate,
but
would
be
improved
with
more
information.
This
information
includes:
analytical
methods
and
method
validation
for
the
currently
registered
Cry
proteins
following
OPPTS
guidelines,
heat
stability
and/
or
processing
data,
amino
acid
sequencing
data
comparing
to
known
toxins,
stepwise
8
amino
acid
fragment
comparisons
to
known
allergens,
post­
translational
modifications
(
i.
e.
potential
glycosylation
sites),
and
as
valid
methods
become
available,
more
complete
analysis
of
the
amino
acid
sequence
expressed
in
the
plant
(
known
as
the
MALDI­
TOF).

a.
Bt
Corn
Tests
have
shown
no
toxicity
to
mammals
from
the
Cry1Ab
and
Cry1F
proteins;
the
proteins
are
readily
digestible
in
gastric
fluids
and
are
non­
glycosylated,
the
proteins
are
inactivated
by
typical
food
processing,
and
anticipated
exposure
of
farm
workers
to
the
proteins
is
negligible.
The
Cry1Ab
protein
acute
oral
toxicity
data
submitted
demonstrated
no
effects
at
the
relatively
high
dose
level
of
4,000
mg/
kg.
The
Cry1F
protein
acute
oral
toxicity
data
submitted
demonstrated
no
effects
at
the
relatively
high
dose
level
of
5,050
mg/
kg.
The
Cry1Ab
and
Cry1F
proteins
were
readily
degraded
in
gastric
fluid
in
vitro.
Exposure
via
the
skin
or
inhalation
is
not
likely
since
the
Cry1Ab
and
Cry1F
proteins
are
contained
within
corn
plant
cells
which
essentially
eliminates
or
reduces
exposure
routes
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I4
to
negligible.
Oral
exposure,
at
very
low
levels,
may
occur
from
ingestion
of
processed
products
and
drinking
water.
Worker
exposure
to
the
Cry
protein
via
seed
dust
is
also
expected
to
be
negligible
because
of
the
low
amount
of
protein
expressed
in
seeds
of
the
transformed
plants.
Taken
in
total,
these
data
allow
the
Agency
to
make
a
determination
that
for
human
health,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population,
including
infants
and
children,
to
the
Cry1Ab
and
Cry1F
proteins
and
the
genetic
material
necessary
for
their
production.
Thus,
EPA
concludes
that
there
are
no
adverse
effects
on
human
health
from
the
use
of
Cry1Ab
or
Cry1F
proteins
expressed
in
corn.

b.
Bt
Cotton
Tests
have
shown
no
toxicity
to
mammals
from
the
Cry1Ac
protein;
the
protein
is
readily
digestible
in
gastric
fluids
and
are
non­
glycosylated,
the
protein
is
inactivated
by
typical
food
processing,
and
anticipated
exposure
to
the
protein
from
farm
workers
are
negligible.
The
Cry1Ac
protein
acute
oral
toxicity
data
submitted
demonstrated
no
effects
at
the
relatively
high
dose
level
of
5,000
mg/
kg.
Cry1Ac
protein
is
degraded
between
two
minutes
and
seven
minutes
by
gastric
fluid
in
vitro.
Exposure
via
the
skin
or
inhalation
is
not
likely
since
the
Cry1Ac
protein
is
contained
within
cotton
plant
cells
which
essentially
eliminates
or
reduces
exposure
routes
to
negligible.
Oral
exposure,
at
very
low
levels,
may
occur
from
ingestion
of
processed
products
and
drinking
water.
Worker
exposure
to
the
Cry
protein
via
seed
dust
is
also
expected
to
be
negligible
because
of
the
low
amount
of
protein
expressed
in
seeds
of
the
transformed
plants.
Taken
in
total,
these
data
allow
the
Agency
to
make
a
determination
that
for
human
health,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population,
including
infants
and
children,
to
the
Cry1Ac
protein
and
the
genetic
material
necessary
for
its
production.
Thus,
EPA
concludes
that
there
are
no
adverse
effects
on
human
health
from
the
use
of
Cry1Ac
protein
expressed
in
cotton.

2.
Ecological
Assessment
The
ecological
assessment
section
of
this
document
focuses
heavily
on
evaluating
the
impacts
of
Bt
plant­
incorporated
protectants
on
non­
target
species.
EPA
recognizes
that
there
has
been
considerable
public
concern
about
the
potential
for
these
products
to
have
significant
and
unintended
consequences
for
non­
target
species
such
as
the
monarch
butterfly.
This
assessment
relies
not
only
on
the
original
data
developed
in
support
of
the
Bt
registrations,
but
additionally,
on
data
developed
and
submitted
to
EPA
under
a
Data
Call­
In
(
DCI)
requirement
as
well
as
recently
published
literature.
Specific
data
is
cited
for
concerns
related
to
gene
outcrossing
and
weediness,
fate
in
soils
and
potential
indirect
effects
on
soil
biota,
direct
effects
on
non­
target
species
including
mammals,
avian
and
aquatic
species,
insects,
lepidoptera,
and
endangered
or
threatened
species.

Since
the
September
2000
version
of
the
risk
and
benefits
assessments
and
the
October
2000
SAP
meeting,
this
section
has
been
updated
to
indicate
1)
Collembola
and
earthworm
tests
are
no
longer
necessary
to
evaluate
risk
to
soil
non­
target
organisms
from
Bt
crops,
2)
additional
Bt
corn
avian
data
with
a
higher
percentage
of
Bt
corn
in
the
diet
may
be
needed
for
a
more
thorough
assessment
of
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I5
chronic
risk,
3)
if
continuing
non­
target
insect
census
data
was
available,
long­
range
risk
characterization
might
be
improved,
4)
additional
Cry
protein
soil
accumulation
data
is
being
considered
to
provide
a
more
complete
exposure
characterization,
5)
Bt
cotton
isolation
distances
may
need
revision
in
Hawaii,
Puerto
Rico,
and
the
Virgin
Islands
due
to
gene
flow
concerns,
and
6)
informal
consultation
with
the
Fish
and
Wildlife
Service
wad
initiated
regarding
the
Karner
Blue
Butterfly.

a.
Bt
Corn
EPA
has
also
reviewed
the
original
data
base
and
the
new
data,
information,
and
comments
regarding
ecological
effects
for
Bt
corn.
EPA
has
reviewed
the
potential
for
gene
capture
and
expression
of
the
Cry1Ab/
Cry1F
endotoxin
in
corn
by
wild
or
weedy
relatives
of
corn
in
the
United
States,
its
possessions
or
territories.
The
Agency
has
determined
that
there
is
no
significant
risk
of
gene
capture
and
expression
of
any
B.
t.
endotoxin
by
wild
or
weedy
relatives
of
corn
product
registrations
in
the
U.
S.,
its
possessions
or
territories.
In
addition,
the
USDA/
APHIS
has
made
this
same
determination
under
its
statutory
authority
under
the
Plant
Pest
Act.

The
Agency
has
concluded
that
based
on
the
weight
of
evidence
there
are
no
unreasonable
adverse
effects
of
Cry1Ab
or
Cry1F
protein
expressed
in
corn
to
non­
target
wildlife
or
beneficial
invertebrates.
However,
EPA
is
requiring
insect
census
estimates
from
representative
fields
to
determine
if
there
are
long­
term
adverse
impacts
from
the
use
of
Bt
corn,
field
tests
of
Cry1Ab
and
Cry1F
protein
accumulation
and/
or
persistence
in
soil
under
a
range
of
conditions
typical
of
Bt
crop
cultivation
as
confirmatory
data,
and
chronic
avian
data.

In
the
Cry1Ab
ecological
effects
testing
done,
no
treatment
related
effects
were
observed
in
Bobwhite
quail
or
catfish
fed
Cry1Ab
corn
as
part
of
their
diet.
No
measurable
deleterious
effects
from
the
Cry1Ab
protein
on
honey
bee
larvae,
honey
bee
adults,
parasitic
wasps,
Ladybird
beetles,
green
lacewings,
Collembola
(
springtails),
and
Daphnia
were
observed
in
submitted
studies.

In
the
Cry1F
ecological
effects
testing
done,
no
treatment
related
effects
were
observed
in
Bobwhite
quail
fed
Cry1Ab
corn
as
part
of
their
diet.
No
measurable
deleterious
effects
from
the
Cry1F
protein
on
honey
bees,
parasitic
wasps,
Ladybird
beetles,
green
lacewings,
Collembola
(
springtails),
earthworms,
Daphnia,
and
Monarch
butterflies
were
observed
in
submitted
studies.

MON
810
and
Bt11
show
relatively
low
toxicity
to
monarch
larvae
and
the
Cry1F
protein
has
no
detectable
impact
on
monarch
larvae.
Overall,
the
available
information
indicates
a
very
low
probability
of
risk
to
monarchs
in
areas
beyond
the
near
edge
of
corn
fields.
Inside
corn
fields
and
at
the
near
edge
of
corn
fields
there
is
low
probability
of
monarch
larvae
encountering
a
toxic
level
of
pollen
for
the
Bt
corn
products
covered
by
this
risk
assessment.

Limited
data
do
not
indicate
that
Cry
proteins
have
any
measurable
effect
on
microbial
populations
in
the
soil.
Horizontal
transfer
from
transgenic
plants
to
soil
bacteria
has
not
been
demonstrated.
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I6
Cry1Ab
protein
bioactivity
from
Cry1Ab
corn
tissue
added
to
the
soil
decreased
with
an
estimated
DT
50
(
Degradation
Time)
of
1.6
days
and
an
estimated
DT
90
of
15
days.
The
bioactivity
of
purified
Cry1Ab
protein
in
soil
decreased
with
an
estimated
DT
50
of
8.3
days
and
a
an
estimated
DT
90
of
32.5
days.
The
bioactivity
of
purified
Cry1F
protein
in
soil
decreased
with
an
estimated
DT
50
of
3.13
days.

b.
Bt
Cotton
EPA
has
also
reviewed
the
original
data
base
and
the
new
data,
information,
and
comments
regarding
ecological
effects
for
Bt
cotton.
EPA
has
reviewed
the
potential
for
gene
capture
and
expression
of
the
Cry1Ac
endotoxin
in
cotton
by
wild
or
weedy
relatives
of
cotton
in
the
United
States,
its
possessions
or
territories.
EPA
has
concluded
that
there
is
a
possibility
for
gene
transfer
in
limited
geographic
locations
where
wild
or
feral
cotton
relatives
exist.
This
transfer
is
of
concern
because
1)
traits
which
enhance
the
survival,
invasiveness
or
adaptability
of
a
plant
have
the
potential
to
increase
the
frequency
of
that
trait
(
allele)
in
the
recipient
population
and
result
in
a
shift
in
community
dynamics
(
e.
g.,
species
abundance,
distribution)
for
multiple
species,
2)
the
native
genome
of
any
wild
species
is
effectively
altered
by
the
introduction
of
an
adaptive
trait
(
e.
g.,
resistance
to
insects,
diseases,
stress)
and
a
net
loss
in
the
biodiversity
of
the
recipient
species
may
occur
as
alleles
or
even
biotypes
of
the
species
are
lost
through
this
genetic
introduction
and
selection,
and
3)
wild
or
feral
species
which
are
genetically
compatible
with
crop
plants
and
other
non­
domesticated
plant
species,
and
are
recipients
of
novel
traits,
may
transfer
these
traits
in
a
reciprocal
fashion
to
these
related
species
in
subsequent
generations.
Therefore,
EPA
has
imposed
restrictions
on
the
planting
of
commercial
cotton
in
southern
Florida,
Hawaii,
Puerto
Rico,
and
the
U.
S.
Virgin
Islands.
In
addition,
restrictions
to
prevent
gene
flow
have
been
imposed
for
test
plots
and
breeding
nurseries
in
Hawaii
and
Puerto
Rico
although
the
registrant
may
provide
data
which
will
allow
EPA
to
ease
or
remove
these
restrictions
in
the
future.

The
Agency
has
concluded
that
the
weight
of
evidence
indicates
no
unreasonable
adverse
effects
of
Cry1Ac
protein
expressed
in
cotton
to
non­
target
wildlife
or
beneficial
invertebrates.
EPA
further
believes
that
cultivation
of
Cry1Ac
cotton
may
result
in
fewer
adverse
impacts
to
non­
target
organisms
than
result
from
the
use
of
chemical
pesticides.
However,
EPA
is
requiring
insect
census
estimates
from
representative
fields
to
determine
if
there
are
long­
term
adverse
impacts
from
the
use
of
Bt
cotton
and
field
tests
of
Cry1Ac
protein
accumulation
and/
or
persistence
in
soil
under
a
range
of
conditions
typical
of
Bt
crop
cultivation
as
confirmatory
data.

In
the
ecological
effects
testing
done,
no
treatment
related
effects
were
observed
in
Bobwhite
quail
fed
Cry1Ac
cottonseed
meal
as
part
of
their
diet.
No
measurable
deleterious
effects
from
the
Cry1Ac
protein
on
honey
bee
larvae,
honey
bee
adults,
parasitic
wasps,
Ladybird
beetles,
green
lacewings
and
Collembola
(
springtails)
were
observed
in
submitted
studies.
The
larvae
of
endangered
Lepidoptera
species
in
cotton
growing
counties
(
Quino
Checkerspot
butterfly,
Saint
Francis'
Satyr
butterfly
and
Kern
Primrose
Sphinx
moth)
are
not
going
to
be
exposed
to
Cry1Ac
protein
because
their
habitats
do
not
overlap
with
cotton
fields.
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I7
Limited
data
do
not
indicate
that
Cry
proteins
have
any
measurable
effect
on
microbial
populations
in
the
soil.
Horizontal
transfer
from
transgenic
plants
to
soil
bacteria
has
not
been
demonstrated.
Purified
microbially
produced
Cry1Ac
protein
produced
a
DT
50
(
Degradation
Time)
of
9.3­
20.2
days.
Ground,
lyophilized
Cry1A(
c)
cotton
line
931tissue
produced
a
DT
50
of
41
days.
Based
upon
estimates
of
60,000
plants
per
acre,
a
total
of
1.44
grams
of
Cry
protein
per
acre
would
enter
the
soil
when
the
cotton
plants
are
incorporated
after
harvest.

3.
Insect
Resistance
Management
Available
data
indicate
that
after
six
years
of
commercialization,
no
reported
insect
resistance
has
occurred
to
the
Bt
toxins
expressed
either
in
Bt
potato,
Bt
corn,
or
Bt
cotton
products.
The
Agency
believes
that
the
existing
IRM
plan
for
Bt
potato
is
adequate
to
mitigate
Colorado
potato
beetle
resistance.
The
existing
IRM
plan
for
Bt
corn
which
had
been
strengthened
for
the
2000
growing
season)
was
strengthened
to
further
mitigate
European
corn
borer,
corn
earworm,
and
southwestern
corn
borer.
The
existing
IRM
plan
for
Bt
cotton
(
already
strengthened
for
the
2001
growing
season)
was
further
strengthened
to
mitigate
tobacco
budworm,
cotton
bollworm,
and
pink
bollworm
resistance
including
requiring
additional
data
to
more
closely
examine
the
effectiveness
of
the
5%
external,
unsprayed
refuge
option.

The
issue
of
insect
resistance
management
has
generated
more
data,
meetings,
and
public
comments
than
all
of
the
other
sections
covered
in
this
BRAD.
Insect
resistance
management
(
IRM)
is
the
set
of
practices
aimed
at
reducing
the
potential
for
insect
pests
to
become
resistant
to
a
pesticide.
Bt
IRM
is
of
great
importance
because
of
the
threat
insect
resistance
poses
to
the
future
use
of
Bt
plantincorporated
protectants
and
Bt
technology
as
a
whole.
EPA
considers
protection
of
insect
(
pest)
susceptibility
of
Bt
to
be
in
the
"
public
good."
EPA
has
determined
that
development
of
resistant
insects
would
constitute
an
adverse
environmental
effect.
In
order
to
delay
the
development
of
insect
resistance
to
Bt
corn
and
cotton
plant­
incorporated
protectants,
EPA
has
mandated
specific
IRM
requirements
to
strengthen
the
existing
IRM
programs
as
part
of
the
terms
and
conditions
of
the
registrations.

a.
Bt
Corn
The
Agency
has
determined
that
the
20%
non­
Bt
field
corn
refuge
requirements
for
Bt
corn
grown
in
the
Corn­
Belt
and
the
50%
non­
Bt
corn
refuge
requirements
for
Bt
corn
grown
in
cotton­
growing
areas
are
scientifically­
sound,
protective,
feasible,
sustainable,
and
practical
to
growers.
Models
have
been
developed
by
scientists
in
academia
to
predict
the
estimated
time
that
insect
resistance
would
develop
to
compare
IRM
strategies
for
Bt
field
corn.
For
example,
if
a
high
dose
is
achieved
to
control
ECB
(
as
it
is
for
the
currently
registered
Bt
corn
products),
then
these
models
predict
that
ECB
will
not
evolve
resistance
for
at
least
99
years
if
a
20%
refuge
is
implemented
in
the
Corn
Belt.
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I8
Models
are
also
used
to
predict
the
evolution
of
CEW
resistance.
These
models
indicate
that
50%
non­
Bt
field
corn
refuge
in
cotton­
growing
areas
is
sufficient
to
delay
CEW
resistance
for
at
least
the
time
frame
of
the
registrations.
A
20%
non­
Bt
field
corn
refuge
in
the
Corn
Belt
is
sufficient
to
delay
CEW
resistance
because
CEW
do
not
overwinter
in
the
Corn
Belt.
EPA
believes
that
the
use
of
these
models
provides
confidence
that
resistance
will
not
evolve
under
the
time
frame
of
the
registrations.

For
Bt
sweet
corn,
no
specific
refuge
requirements
are
necessary
because
sweet
corn
is
typically
harvested
much
earlier
than
field
corn,
18­
21
days
after
silking,
and
before
most
lepidopteran
larvae
complete
development.
However,
to
mitigate
the
development
of
resistance,
EPA
has
determined
that
crop
residue
destruction
is
necessary
within
30
days.
This
practice
will
likely
destroy
any
live
larvae
left
in
Bt
sweet
corn
stalks
and
prevent
overwintering
of
any
resistant
insects.

The
IRM
program
for
Bt
field
and
sweet
corn
also
require:
1)
anyone
purchasing
Bt
corn
to
sign
a
grower
agreement
which
contractually
binds
the
grower
to
comply
with
the
IRM
program
and
that
there
will
be
a
mechanism
by
the
year
2003
by
which
every
grower
affirms,
annually,
their
contractual
obligations
to
comply
with
the
IRM
program,
2)
an
IRM
education
program,
3)
an
IRM
compliance
monitoring
program
including
a
third
party
compliance
survey
and
mechanisms
to
address
noncompliance
4)
an
insect
resistance
monitoring
program
for
each
target
insect
pest,
5)
remedial
action
plans
to
be
implemented
if
resistance
does
develop,
and
6)
annual
reporting
of
the
IRM
(
and
other)
activities.
No
other
pesticide
products
than
the
Bt
crop
products
have
such
extensive
IRM
requirements.

b.
Bt
Cotton
At
this
time,
the
Agency
believes
that
available
empirical
data
substantiate
the
success
of
the
5%
external
unsprayed,
20%
external
sprayed,
and
5%
embedded
structured
refuge
options
to
delay
resistance.
However,
EPA
believes
that
it
is
imprudent
to
allow
the
5%
external,
unsprayed
refuge
option
for
more
than
a
limited
period
of
time
because
current
data
indicates
that
this
option
has
a
significantly
greater
likelihood
of
insect
resistance
than
either
of
the
other
refuge
options.
The
2000
SAP
stated
that
the
external,
unsprayed
option
poses
the
highest
risk
to
resistance
evolution
especially
for
cotton
bollworm.
Therefore,
the
external,
unsprayed
option
expires
after
three
growing
seasons
(
September
30,
2004).
During
the
next
two
years,
the
registrant
is
required
to
develop
considerable
new
data
on
alternative
host
plants
as
possible
effective
refuges.
In
addition,
the
registrant
is
required
to
submit
protocols
by
December
1,
2001,
to
begin
field
tests
on
alternative
hosts
and
chemical
insecticide
sprays
on
Bt
cotton,
and
to
provide
annual
reports
each
January
31st.
If
any
of
these
terms
and
conditions
are
not
met,
the
external,
unsprayed
refuge
option
will
be
eliminated.
If,
based
upon
these,
and
any
other
pertinent
data,
the
registrant
requests
an
amendment
to
the
registration
extending
the
expiration
date
of
the
external,
unsprayed
option,
EPA
will
conduct
a
comprehensive
assessment
of
whether
all
relevant
data
support
such
regulatory
action,
as
part
of
a
larger
requirement
that
would
also
likely
involve
alternative
host
plants.
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I9
In
addition,
the
Agency
is
mandating
additional
improvements
to
the
current
IRM
programs
that
will
require:
1)
anyone
purchasing
Bt
cotton
to
sign
a
grower
agreement
which
contractually
binds
the
grower
to
comply
with
the
IRM
program
and
that
there
will
be
a
mechanism
by
the
year
2003
by
which
every
grower
affirms
their
contractual
obligations
to
comply
with
the
IRM
program,
2)
an
ongoing
IRM
education
program,
3)
an
ongoing
IRM
compliance
monitoring
program
including
a
third
party
compliance
survey
and
mechanisms
to
address
non­
compliance,
4)
and
ongoing
insect
resistance
monitoring
program
for
each
target
insect
pest,
5)
remedial
action
plans
to
be
implemented
if
resistance
does
develop,
and
6)
annual
reporting
of
the
IRM
(
and
other)
activities.
No
other
pesticide
products
than
the
Bt
crop
products
have
such
extensive
IRM
requirements.

4.
Benefits
EPA
believes
that
significant
benefits
accrue
to
growers,
the
public,
and
the
environment
from
the
availability
and
use
of
certain
Bt
plant­
incorporated
protectants.
This
section
outlines
how
those
benefits
are
defined
and
evaluated.
Specific
information
on
grower
cost
savings,
increased
yields,
reduced
conventional
pesticide
use,
benefits
to
wildlife,
etc.
is
presented
by
product.
Direct
benefits
to
growers
for
all
Bt
products
is
estimated
to
be
less
than
$
350
million
in
2000.
Major
environmental
benefits
occur
through
less
insecticide
use
and
improved
product
quality.

a.
Bt
Corn
In
addition
to
assessing
the
risks
from
the
use
of
Cry1Ab
and
Cry1F
expressed
in
corn,
EPA
has
evaluated
the
benefits
from
the
use
of
these
products.
Direct
grower
benefits
include
improved
yield
and
profitability,
improved
crop
management
effectiveness,
reduction
in
farming
risk,
and
improved
opportunity
to
grow
field
corn
in
case
of
severe
pest
infestation.
Total
annual
monetary
grower
benefits
from
the
use
of
Bt
field
corn
are
less
than
$
219
million
annually.
The
magnitude
of
benefits
for
any
year
is
largely
a
function
of
the
level
of
lepidopteran
insect
pressure
in
that
year.
That
is,
other
things
being
equal,
the
higher
the
insect
pressure,
the
higher
the
benefits.
The
major
environmental
benefit
is
potential
reduction
in
mycotoxins.
EPA
believes
that
use
of
Bt
sweet
corn
would
result
in
significant
reductions
in
the
use
of
chemical
pesticides.
However,
the
current
use
of
Bt
sweet
corn
is
very
low.

b.
Bt
Cotton
In
addition
to
assessing
the
risks
from
the
use
of
Cry1Ac
expressed
in
cotton,
EPA
has
evaluated
the
benefits
from
the
use
of
this
product.
Direct
grower
benefits
include
reduced
pesticide
use,
improved
crop
management
effectiveness,
reduced
production
costs,
improved
yield
and
profitability,
reduction
in
farming
risk,
and
improved
opportunity
to
grow
cotton
in
areas
of
severe
pest
infestation.
Total
monetary
grower
benefits
from
the
use
of
Bt
cotton
are
between
$
60
million
and
$
126
million.
Indirect
benefits
may
include
improved
populations
of
beneficial
insects
and
wildlife
in
cotton
fields,
reduced
pesticides
runoff,
reduced
air
pollution
and
waste
from
the
use
of
chemical
insecticides,
improved
farm
worker
and
neighbor
safety,
and
reduction
of
fossil
fuel
use.
EPA
believes
that
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I10
cultivation
of
Cry1Ac
cotton
may
result
in
fewer
adverse
impacts
to
non­
target
organisms
than
result
from
the
use
of
chemical
pesticides.

5.
Confirmatory
Data
and
Terms
and
Conditions
of
the
Amendment
a.
Confirmatory
Data
i.
Bt
Corn
The
following
table
outlines
the
confirmatory
data
that
must
be
provided
to
EPA
as
a
condition
of
the
amendment
to
the
Cry1Ab
and
Cry1F
corn
product
registrations
including
the
due
dates
for
the
protocols
and
the
data.

Data
Description
Due
Date
Residue
Analytical
Methods
Analytical
method
including
characterization
of
the
antisera
and
independent
laboratory
validation
required
June
1,
2002
Protein
Expression
Expression
data
provided
for
initial
registration;
confirmatory
data
required
to
provide
consistency
across
Bt
crops
March
15,
2003
For
Bt11:
Amino
Acid
Sequencing
Comparison
of
AA
sequence
to
known
toxins
and
allergens
Stepwise
8
amino
acid
analysis
March
15,
2003
For
MON810:
Amino
Acid
Sequencing
and
heat
stability
Stepwise
8
amino
acid
analysis
and
processing
and/
or
heat
stability
study
March
15,
2003
Cry1Ab
Protein
Levels
in
Soil
Supplemental
studies;
protocol
to
be
submitted
before
studies
are
initiated
Protocol
by
March
15,
2002;
interim
report
12
months
after
protocol
approved;
final
report
24
months
after
protocol
approved
Cry1F
Protein
Levels
in
Soil
Supplemental
studies;
protocol
to
be
submitted
before
studies
are
initiated
Protocol
by
March
15,
2002;
final
report
due
no
later
than
March
15,
2008
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I11
Non­
target
Insects
Either
existing
studies
or
protocol
and
studies
Existing
studies
or
protocol
by
March
15,
2002;
interim
report
12
months
after
protocol
approved;
final
report
36
months
after
protocol
approved
Monarch
Long­
Term
Exposure
for
Cry1Ab
Examine
fitness
and
reproductive
costs
to
monarchs
from
subchronic
exposure
to
Bt
corn
January
31,
2003
or
earlier.

Chronic
Avian
Study
Test
a
diet
for
chronic
exposure
to
high
levels
of
Bt
corn
that
may
occur
in
the
field
Existing
studies
or
protocol
by
March
15,
2003;
final
report
18
months
after
approval
of
protocol.

IRM
 
North/
South
Movement
of
Corn
Earworm
Potential
for
north
to
south
movement
of
corn
earworm
Protocol
by
March
15
2002;
interim
report
12
months
after
protocol
approved;
final
report
24
months
after
protocol
approved
IRM
 
Insecticide
Impact
on
Effectiveness
of
Refuge
Studies
in
areas
where
the
refuge
is
commonly
treated
with
insecticides
Protocol
March
15,
2002;
interim
report
in
12
months;
final
report
in
24
months
after
protocol
submitted
or
approved
IRM
 
Discriminating
Concentration
for
Cry1F
Development
of
discriminating
concentration
for
ECB,
CEW,
SWCB
Studies
must
be
submitted
on
or
before
March
15,
2003
ii.
Bt
Cotton
The
following
table
outlines
the
confirmatory
data
that
must
be
provided
to
EPA
as
a
condition
of
the
amendment
to
the
Cry1Ac
cotton
product
registration
including
the
due
dates
for
the
protocols
and
the
data.

Data
Description
Due
Date
Residue
Analytical
Methods
Method
submitted,
but
independent
laboratory
validation
required
June
1,
2002
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I12
Protein
Expression
Expression
data
provided
for
initial
registration;
confirmatory
data
required
to
provide
consistency
across
Bt
crops
March
15,
2003
Amino
Acid
and
DNA
Sequence
Stepwise
8
amino
acid
analysis
March
15,
2003
Cry
Protein
Levels
in
Soil
Supplemental
studies;
protocol
to
be
submitted
before
studies
are
initiated
Protocol
March
15,
2002;
interim
report
January
31,
2003;
final
report
January
31,
2004
Non­
target
Insects
Either
existing
studies
or
protocol
and
studies
Existing
studies
or
protocol
March
15,
2002;
studies
due
January
31,
2005
IRM
 
north/
south
movement
of
cotton
bollworm
Potential
for
north
to
south
movement
of
cotton
bollworm
January
31,
2004
IRM
 
Alternate
Hosts/
Insecticide
sprays
Alternate
host
data
as
an
effective
refuge
and
sprays
with
chemical
insecticides
to
enhance
Bt
cotton
IRM
effectiveness
Protocol
December
1,
2001;
final
protocol
March
15,
2002;
interim
report
March
15,
2003
and
final
March
15,
2004
b.
Gene
Flow
Containment
Provisions
i.
Bt
Corn
No
provisions.

ii.
Bt
Cotton
Until
thorough
research
on
the
impacts
of
gene
flow
can
be
completed,
restriction
on
where
Bt
cotton
can
be
planted
are
being
implemented.
The
following
terms
and
conditions
must
be
instituted
to
mitigate
gene
flow
concerns:

a.
No
planting
of
Bt­
cotton
south
of
Route
60
(
near
Tampa)
in
Florida,
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I13
b.
Commercial
culture
of
Bt­
cotton
is
prohibited
in
the
state
of
Hawaii,
c.
Test
plots
or
breeding
nurseries
established
in
Hawaii
must
be
surrounded
by
24
border
rows
of
a
suitable
pollinator
trap
crop
regardless
of
the
plot
size
and
must
not
be
planted
within
3
miles
of
Gossypium
tomentosum,
d.
Commercial
culture,
experimental
plots
and
breeding
nurseries
of
Bt.­
cotton
are
prohibited
in
the
U.
S.
Virgin
Islands,
and
e.
Commercial
culture
of
Bollgard
 
cotton
is
prohibited
in
Puerto
Rico.
Test
plots
or
breeding
nurseries
established
on
the
island
of
Puerto
Rico
must
be
surrounded
by
24
border
rows
of
a
suitable
pollinator
trap
crop
regardless
of
the
plot
size
and
must
not
be
planted
within
3
miles
of
feral
cotton
plants.

Upon
approval
by
EPA,
test
plots
and/
or
breeding
nurseries
in
Hawaii,
the
U.
S.
Virgin
Islands,
and
Puerto
Rico
may
be
established
without
restrictions
if
alternative
measures,
such
as
insecticide
applications,
are
shown
to
effectively
mitigate
gene
flow.

c.
Insect
Resistance
Management
(
IRM)
Program
i.
Bt
Corn
The
Agency
has
determined
that
the
unrestricted
use
of
Cry1Ab
and/
or
Cry1F
in
corn
is
likely
to
lead
to
the
emergence
of
resistance
in
one
or
more
of
the
target
insect
pests
unless
measures
are
used
to
delay
or
halt
the
development
of
resistant
insects.
Because
some
corn
pests
also
attack
other
crops,
not
only
would
the
emergence
of
resistance
affect
the
benefits
of
Bt
corn,
such
insect
resistance
could
also
affect
the
efficacy
of
Bt
cotton
products
and
microbial
formulations
of
Bt.
The
loss
of
Bt
as
an
effective
pest
management
tool
 
in
field
corn,
sweet
corn,
or
other
crops
 
could
potentially
have
serious
adverse
consequences
for
the
environment
to
the
extent
that
growers
might
shift
to
the
use
of
more
toxic
pesticides
and
a
valuable
tool
for
organic
farmers
might
be
lost.
The
emergence
of
resistance
in
corn
pests
could
also
have
significant
economic
consequences
for
corn
growers.
Therefore,
EPA
continues
to
require
the
registrants
to
implement
an
Insect
Resistance
Management
(
IRM)
program
to
mitigate
the
possibility
that
pest
resistance
will
occur.

The
required
IRM
program
for
Bt
corn
has
the
following
elements:

1]
Requirements
relating
to
creation
of
a
non­
Bt
corn
refuge
in
conjunction
with
the
planting
of
any
acreage
of
Bt
field
corn;

2]
Requirements
for
the
registrants
to
prepare
and
require
Bt
corn
users
to
sign
"
grower
agreements"
which
impose
binding
contractual
obligations
on
the
grower
to
comply
with
the
refuge
requirements;

3]
Requirements
for
the
registrants
to
develop,
implement,
and
report
to
EPA
on
programs
to
educate
growers
about
IRM
requirements;
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I14
4]
Requirements
for
the
registrants
to
develop,
implement,
and
report
to
EPA
on
programs
to
evaluate
and
promote
growers'
compliance
with
IRM
requirements;

5]
Requirements
for
the
registrants
to
develop,
implement,
and
report
to
EPA
on
programs
to
evaluate
whether
there
are
statistically
significant
and
biologically
relevant
changes
in
target
insect
susceptibility
to
Cry1Ab
protein
and/
or
Cry1F
in
the
target
insects;

6]
Requirements
for
the
registrants
to
develop,
and
if
triggered,
to
implement
a
"
remedial
action
plan"
which
would
contain
measures
the
registrants
would
take
in
the
event
that
any
insect
resistance
was
detected
as
well
as
to
report
on
activity
under
the
plan
to
EPA;

7]
Submit
annual
reports
on
sales,
IRM
grower
agreements
results,
compliance,
and
educational
program
on
or
before
January
31st
each
year.

a.
Refuge
Requirements
1)
Field
Corn
a)
Corn­
Belt
Refuge
Requirements
For
Cry1Ab
and
Cry1F
Bt
field
corn
grown
outside
cotton­
growing
areas
(
e.
g.,
the
Corn
Belt),
grower
agreements
(
also
known
as
stewardship
agreements)
will
specify
that
growers
must
adhere
to
the
refuge
requirements
as
described
in
the
grower
guide/
product
use
guide
and/
or
in
supplements
to
the
grower
guide/
product
use
guide.

!
Specifically,
growers
must
plant
a
structured
refuge
of
at
least
20%
non­
Bt
corn
that
may
be
treated
with
insecticides
as
needed
to
control
lepidopteran
stalk­
boring
and
other
pests.

!
Refuge
planting
options
include:
separate
fields,
blocks
within
fields
(
e.
g.,
along
the
edges
or
headlands),
and
strips
across
the
field.

!
External
refuges
must
be
planted
within
½
mile
(
1/
4
mile
or
closer
preferred).

!
When
planting
the
refuge
in
strips
across
the
field,
refuges
must
be
at
least
4
rows
wide,
preferably
6
rows
wide.

!
Insecticide
treatments
for
control
of
ECB,
CEW
and
Southwestern
corn
borer
(
SWCB)
[
Cry1Ab
or
Cry1F
corn
hybrids]
and/
or
fall
armyworm
(
FAW)
and
black
cutworm
(
BCW)
[
Cry1F
corn
hybrids
only]
may
be
applied
only
if
economic
thresholds
are
reached
for
one
or
more
of
these
target
pests.
Economic
thresholds
will
be
determined
using
methods
recommended
by
local
or
regional
professionals
(
e.
g.,
Extension
Service
agents,
crop
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
1Counties
selected
based
on
approximately
1000
A
Bt
cotton/
5000
A
total
cotton
using
1999­
2001
cotton
acreage
reports
from
Monsanto
and
USDA/
NASS.

I15
consultants).
Instructions
to
growers
will
specify
that
microbial
Bt
insecticides
must
not
be
applied
to
non­
Bt
corn
refuges.

b)
Cotton­
Growing
Area
Refuge
Requirements
for
Bt
Corn
For
Cry
1Ab
and
Cry1F
Bt
field
corn
grown
in
cotton­
growing
areas,
grower
agreements
(
also
known
as
stewardship
agreements)
will
specify
that
growers
must
adhere
to
the
refuge
requirements
as
described
in
the
grower
guide/
product
use
guide
and/
or
in
supplements
to
the
grower
guide/
product
use
guide.

!
Specifically,
growers
in
these
areas
must
plant
a
structured
refuge
of
at
least
50%
non­
Bt
corn
that
may
be
treated
with
insecticides
as
needed
to
control
lepidopteran
stalk­
boring
and
other
pests.

!
Refuge
planting
options
include:
separate
fields,
blocks
within
fields
(
e.
g.,
along
the
edges
or
headlands),
and
strips
across
the
field.

!
External
refuges
must
be
planted
within
½
mile
(
1/
4
mile
or
closer
preferred).

!
When
planting
the
refuge
in
strips
across
the
field,
refuges
must
be
at
least
4
rows
wide,
preferably
6
rows
wide.

!
Insecticide
treatments
for
control
of
ECB,
CEW
and
Southwestern
corn
borer
(
SWCB)
[
Cry1Ab
or
Cry1F
corn
hybrids]
and/
or
fall
armyworm
(
FAW)
and
black
cutworm
(
BCW)
[
Cry1F
corn
hybrids
only]
may
be
applied
only
if
economic
thresholds
are
reached
for
one
or
more
of
these
target
pests.
Economic
thresholds
will
be
determined
using
methods
recommended
by
local
or
regional
professionals
(
e.
g.,
Extension
Service
agents,
crop
consultants).
Instructions
to
growers
will
specify
that
microbial
Bt
insecticides
must
not
be
applied
to
non­
Bt
corn
refuges.

!
Cotton­
growing
areas1
include
the
following
states:
Alabama,
Arkansas,
Georgia,
Florida,
Louisiana,
North
Carolina,
Mississippi,
South
Carolina,
Oklahoma
(
only
the
counties
of
Beckham,
Caddo,
Comanche,
Custer,
Greer,
Harmon,
Jackson,
Kay,
Kiowa,
Tillman,
Washita),
Tennessee
(
only
the
counties
of
Carroll,
Chester,
Crockett,
Dyer,
Fayette,
Franklin,
Gibson,
Hardeman,
Hardin,
Haywood,
Lake,
Lauderdale,
Lincoln,
Madison,
Obion,
Rutherford,
Shelby,
and
Tipton),
Texas
(
except
the
counties
of
Carson,
Dallam,
Hansford,
Hartley,
Hutchinson,
Lipscomb,
Moore,
Ochiltree,
Roberts,
and
Sherman),
Virginia
(
only
the
counties
of
Dinwiddie,
Franklin
City,
Greensville,
Isle
of
Wight,
Northampton,
Southampton,
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I16
Suffolk
City,
Surrey,
Sussex)
and
Missouri
(
only
the
counties
of
Dunkin,
New
Madrid,
Pemiscot,
Scott,
Stoddard).
The
correct
list
of
counties
must
be
in
the
2003
grower
guide
and
may
be
provided
as
a
supplement
for
the
2002
growing
season.

b.
Sweet
Corn
Post­
Harvest
Requirements
Sweet
corn
is
harvested
long
before
field
corn.
Therefore,
if
the
sweet
corn
stalks
remaining
in
the
field
and
any
insects
remaining
in
the
stalks
are
destroyed
shortly
after
harvest,
a
refuge
is
not
needed
as
a
part
of
the
IRM
program
for
sweet
corn.
Growers
must
adhere
to
the
following
types
of
crop
destruction
requirements
as
described
in
the
grower
guide/
product
use
guide
and/
or
in
supplements
to
the
grower
guide/
product
use
guide.

!
Crop
destruction
must
occur
no
later
than
30
days
following
harvest,
but
preferably
within
14
days.

!
The
allowed
crops
destruction
methods
are:
rotary,
mowing,
discing,
or
plow­
down.
Crop
destruction
methods
should
destroy
any
surviving
resistant
insects.

ii.
Bt
Cotton
The
Agency
has
determined
that
the
unrestricted
use
of
Cry1Ac
as
expressed
in
cotton
is
likely
to
lead
to
the
emergence
of
resistance
in
one
or
more
of
the
target
insect
pests
unless
measures
are
used
to
delay
or
halt
the
development
of
resistant
insects.
EPA
is
requiring
the
registrant
to
implement
an
Insect
Resistance
Management
(
IRM)
program
to
mitigate
the
possibility
that
pest
resistance
will
occur.
The
required
IRM
program
for
Bt
cotton
has
the
following
elements:

1]
Requirements
relating
to
creation
of
a
non­
Bt
cotton
refuge
in
conjunction
with
the
planting
of
any
acreage
of
Bt
cotton;

2]
Requirements
for
the
registrant
to
prepare
and
require
Bt
cotton
users
to
sign
"
grower
agreements"
which
impose
binding
contractual
obligations
on
the
grower
to
comply
with
the
refuge
requirements;

3]
Requirements
for
the
registrant
to
develop,
implement,
and
report
to
EPA
on
programs
to
educate
growers
about
IRM
requirements;

4]
Requirements
for
the
registrant
to
develop,
implement,
and
report
to
EPA
on
programs
to
evaluate
and
promote
growers'
compliance
with
IRM
requirements;

5]
Requirements
for
the
registrant
to
develop,
implement,
and
report
to
EPA
on
programs
to
evaluate
whether
there
are
statistically
significant
and
biologically
relevant
changes
in
susceptibility
to
Cry1Ac
protein
in
the
target
insects;
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I17
6]
Requirements
for
the
registrant
to
develop,
and
if
triggered,
to
implement
a
"
remedial
action
plan"
which
would
contain
measures
the
registrant
would
take
in
the
event
that
any
insect
resistance
was
detected
as
well
as
to
report
on
activity
under
the
plan
to
EPA;

7]
Submit
annual
reports
on
or
before
January
31st
each
year.

All
growers
of
Bt
cotton
must
employ
one
of
the
following
structured
refuge
options:

External,
Unsprayed
Refuge
Ensure
that
at
least
5
acres
of
non­
Bt
cotton
(
refuge
cotton)
is
planted
for
every
95
acres
of
Bt
cotton.
The
size
of
the
refuge
must
be
at
least
150
feet
wide,
but
preferably
300
feet
wide.
This
refuge
may
not
be
treated
with
sterile
insects,
pheromones,
or
any
insecticide
(
except
listed
below)
labeled
for
the
control
of
tobacco
budworm,
cotton
bollworm,
or
pink
bollworm.
The
refuge
may
be
treated
with
acephate
or
methyl
parathion
at
rates
which
will
not
control
tobacco
budworm
or
the
cotton
bollworm
(
equal
to
or
less
than
0.5
lbs
active
ingredient
per
acre).
The
variety
of
cotton
planted
in
the
refuge
must
be
comparable
to
Bt
cotton,
especially
in
the
maturity
date,
and
the
refuge
must
be
managed
(
e.
g.,
planting
time,
use
of
fertilizer,
weed
control,
irrigation,
termination,
and
management
of
other
pests)
similarly
to
Bt
cotton.
Ensure
that
a
non­
Bt
cotton
refuge
is
maintained
within
at
least
½
linear
mile
(
preferably
adjacent
to
or
within
1/
4
mile
or
closer)
from
the
Bt
cotton
fields.
This
option
expires
after
the
2004
growing
season
unless
extended
by
amendment
as
described
below.
EPA
intends
to
review
the
data
specified
in
the
data
requirements
concerning
alternate
hosts
and
chemical
insecticide
sprays
applied
to
Bt
cotton,
and
decide
in
2004
whether
the
new
data
support
continuation
of
an
external,
unsprayed
refuge
as
part
of
a
larger
requirement
that
would
also
likely
involve
alternative
host
plants.
If
these
data
support
the
continued
availability
of
the
external,
unsprayed
refuge
option,
EPA
may
approve
an
amendment
to
this
registration
to
maintain
the
availability
of
this
option.

External
Sprayed
Refuge
Ensure
that
at
least
20
acres
of
non­
Bt
cotton
are
planted
as
a
refuge
for
every
80
acres
of
Bt
cotton
(
total
of
100A)
.
The
variety
of
cotton
planted
in
the
refuge
must
be
comparable
to
Bt
cotton,
especially
in
the
maturity
date,
and
the
refuge
must
be
managed
(
e.
g.,
planting
time,
use
of
fertilizer,
weed
control,
irrigation,
termination,
and
management
of
other
pests)
similarly
to
Bt
cotton.
The
non­
Bt
cotton
may
be
treated
with
sterile
insects,
insecticides
(
excluding
foliar
Btk
products),
or
pheromones
labeled
for
control
of
the
tobacco
budworm,
cotton
bollworm,
or
pink
bollworm.
Ensure
that
a
non­
Bt
refuge
is
maintained
within
at
least
1
linear
mile
(
preferably
within
½
mile
or
closer)
from
the
Bt
cotton
fields.

Embedded
Refuge
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I18
Plant
at
least
5
acres
of
non­
Bt
cotton
(
refuge
cotton)
for
every
95
acres
of
Bt
cotton.
The
refuge
cotton
must
be
embedded
as
a
contiguous
block
within
the
Bt
cotton
field,
but
not
at
one
edge
of
the
field
(
i.
e.,
refuge
block(
s)
surrounded
by
Bt
cotton).
For
very
large
fields,
multiple
blocks
across
the
field
may
be
used.
For
small
or
irregularly
shaped
fields,
neighboring
fields
farmed
by
the
same
grower
can
be
grouped
into
blocks
to
represent
a
larger
field
unit,
provided
the
block
exists
within
one
mile
squared
of
the
Bt
cotton
and
the
block
is
at
least
150
feet
wide,
but
preferably
300
feet
wide.
Within
the
larger
field
unit,
one
of
the
smaller
fields
planted
to
non­
Bt
cotton
may
be
utilized
as
the
embedded
refuge.
The
variety
of
cotton
planted
in
the
refuge
must
be
comparable
to
Bt
cotton,
especially
in
the
maturity
date,
and
the
refuge
must
be
managed
(
e.
g.,
planting
time,
use
of
fertilizer,
weed
control,
irrigation,
and
management
of
other
pests)
similarly
to
Bt
cotton.
This
refuge
may
be
treated
with
sterile
insects,
any
insecticide
(
excluding
foliar
Btk
products),
or
pheromones
labeled
for
the
control
of
tobacco
budworm,
cotton
bollworm,
or
pink
bollworm
whenever
the
entire
field
is
treated.
The
refuge
may
not
be
treated
independently
of
the
surrounding
Bt
cotton
field
in
which
it
is
embedded
(
or
fields
within
a
field
unit).

Embedded
Refuge
for
Pink
Bollworm
Only
Plant
the
refuge
cotton
as
at
least
one
single
non­
Bt
cotton
row
for
every
six
to
ten
rows
of
Bt
cotton.
The
refuge
may
be
treated
with
sterile
insects,
any
insecticide
(
excluding
foliar
Btk
products),
or
pheromones
labeled
for
the
control
of
pink
bollworm
whenever
the
entire
field
is
treated.
The
in­
field
refuge
rows
may
not
be
treated
independently
of
the
surrounding
Bt
cotton
field
in
which
it
is
embedded.
The
refuge
must
be
managed
(
fertilizer,
weed
control,
etc.)
identically
to
the
Bt
cotton.
There
is
no
field
unit
option.

Optional
Community
Refuge
Pilot
This
option
allows
multiple
growers
to
manage
refuge
for
external,
unsprayed
and
external,
sprayed
refuge
options
or
both.
This
option
is
not
allowed
for
the
embedded/
in­
field
options.
A
community
refuge
program
will
be
allowed
as
a
continuing
pilot
for
the
2002
growing
season.
The
community
refuge
for
insect
resistance
management
must
meet
the
requirements
of
either
the
5%
external
unsprayed
refuge
and/
or
the
20%
sprayed
option,
or
an
appropriate
combination
of
the
two
options.
The
registrant
must
implement
the
2002
community
refuge
pilot
program
as
described
in
the
Bollgard
®
Cotton
2002
Refuge
Guide.

6.
Regulatory
Position
on
Bt
Corn
EPA's
finding
that
Cry1Ab
or
Cry1F
protein
expressed
in
corn
will
not
significantly
increase
the
risk
of
unreasonable
adverse
effects
on
the
environment
is
based
on
the
analysis
contained
in
the
succeeding
sections
of
this
BRAD
and
the
specific
terms
and
conditions
that
are
imposed
upon
this
registration,
as
set
forth
in
Section
V.
In
general
terms,
EPA
concludes
that
use
of
Cry1Ab
or
Cry1F
as
expressed
in
corn
is
effective
at
controlling
significant
lepidopteran
pests
of
corn
including
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I19
European
corn
borer,
corn
earworm,
and
southwestern
corn
borer.
Therefore,
these
products
have
clear
benefits
for
users.
Beyond
these
economic
benefits,
EPA
determines
that
Cry1Ab
and
Cry1F
corn
hybrids,
to
the
extent
they
are
an
alternative
to
the
use
of
other
corn
insecticides,
will
provide
benefits
in
that
use
of
Cry1Ab
or
Cry1F
protein
expressed
in
corn
results
in
less
human
and
environmental
risk
than
chemical
alternatives.
In
addition,
EPA
finds
that
the
use
of
these
products,
subject
to
the
specific
terms
and
conditions
set
forth
below,
would
not
pose
risks
to
human
health
or
to
non­
target
species.
EPA
also
concludes
that
the
use
of
Cry1Ab
or
Cry1F
corn
hybrids
expressed
in
corn
raises
concerns
with
respect
to:
insect
resistance
management.
As
discussed
below,
the
registrations
for
Cry1Ab
and
Cry1F
proteins
expressed
in
corn
is
subject
to
specific
terms
and
conditions
that
effectively
restrict
the
use
of
the
product
in
ways
that
EPA
determines
will
adequately
mitigate
these
concerns.
Therefore,
EPA
determines
that
the
allowed
use
will
not
significantly
increase
the
risk
of
unreasonable
adverse
effects
on
the
environment.
Finally,
EPA
has
identified
the
need
for
certain
confirmatory
data
on
potential
accumulation
of
Cry1Ab
and
Cry1F
proteins
in
soil
and
field
impacts
of
Cry1Ab
and
Cry1F
proteins
on
non­
target
species.
The
registration
of
these
products
is
specifically
conditioned
on
submission
of
these
data
7.
Regulatory
Position
on
Bt
Cotton
The
Bt
cotton
product
was
registered
for
commercial
use
in
October
1995
as
a
conditional
registration
under
FIFRA
Section
3(
c)(
7)(
B).
The
data
reviewed
for
the
initial
registration
as
well
as
new
data
and
reports
received,
results
of
public
meeting,
hearings,
workshops,
forums,
and
Scientific
Advisory
Panel
meetings,
and
public
comments
received
regarding
the
Bt
crops
reassessment
have
been
taken
into
consideration.
The
scientific
assessment
has
included
product
characterization,
human
health
effects,
gene
flow,
effects
on
non­
target
organisms,
ecological
exposure,
insect
resistance
management,
and
benefits.
Over
the
last
six
years,
new
data
and
information
have
been
provided
to
the
Agency
in
each
of
these
areas
and
these
data
have
been
incorporated
into
the
science
assessment
and
been
taken
into
account
in
making
regulatory
decisions.

The
Cry1Ac
product
registration
will
automatically
expire
on
midnight
September
30,
2006
except
for
the
external,
unsprayed
refuge
option
which
will
expire
September
30,
2004.
EPA
intends
to
review
the
data
specified
in
the
data
requirements
concerning
alternate
hosts
and
chemical
insecticide
sprays
on
Bt
cotton,
and
decide
in
2004
whether
the
new
data
support
continuation
of
an
external,
unsprayed
refuge
as
part
of
a
larger
requirement
that
would
also
likely
involve
alternative
host
plants.
If
these
data
support
the
continued
availability
of
the
external,
unsprayed
refuge
option,
EPA
may
approve
an
amendment
to
this
registration
to
maintain
the
availability
of
this
option.

EPA's
finding
that
Cry1Ac
protein
expressed
in
cotton
will
not
significantly
increase
the
risk
of
unreasonable
adverse
effects
on
the
environment
is
based
on
the
analysis
contained
in
the
preceding
sections
of
this
BRAD
and
the
specific
terms
and
conditions
that
are
imposed
upon
this
registration,
as
set
forth
in
Section
III.
In
general
terms,
EPA
concludes
that
use
of
Cry1Ac
expressed
in
cotton
is
effective
at
controlling
significant
lepidopteran
pests
of
cotton,
including
tobacco
budworm,
cotton
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I20
bollworm,
and
pink
bollworm.
Therefore,
this
product
has
clear
benefits
for
users.
Beyond
these
economic
benefits,
EPA
determines
that
Cry1Ac
provides
benefits
as
an
alternative
to
the
use
of
other
cotton
insecticides
in
that
use
of
Cry1Ac
protein
expressed
in
cotton
results
in
less
human
and
environmental
risk.
In
addition,
EPA
finds
that
the
use
of
this
product,
subject
to
the
specific
terms
and
conditions
set
forth
below,
would
not
pose
risks
to
human
health
or
to
non­
target
species.
EPA
also
concludes
that
the
use
of
Cry1Ac
expressed
in
cotton
raises
concerns
with
respect
to:
1)
the
risk
of
gene
flow
to
feral
cotton
species;
and
2)
insect
resistance
management.
As
discussed
below,
the
registration
for
Cry1Ac
protein
expressed
in
cotton
is
subject
to
specific
terms
and
conditions
that
effectively
restrict
the
use
of
the
product
in
ways
that
EPA
determines
will
adequately
mitigate
these
concerns.
Therefore,
EPA
determines
that
the
allowed
use
will
not
significantly
increase
the
risk
of
unreasonable
adverse
effects
on
the
environment.
Finally,
EPA
has
identified
the
need
for
certain
confirmatory
data
on
potential
accumulation
of
Cry1Ac
protein
in
soil
and
field
impacts
of
Cry1Ac
protein
on
non­
target
species.

B.
Bt
Corn
Plant­
incorporated
protectants
1.
Bt11,
Cry1Ab
Bt
Corn
OPP
Chemical
Code:
006444
Pesticide
Name:
Bacillus
thuringiensis
Cry1Ab
Delta­
Endotoxin
and
the
Genetic
Material
Necessary
for
Its
Production
(
Plasmid
Vector
pZ01502)
in
Corn
Trade
and
Other
Names:
Bt11,
YieldGard
®
,
AttributeJ
Uses:
Full
Commercial
Use
in
Field
Corn
and
Sweet
Corn
Registrants:

Syngenta
Seeds,
Inc.
­
Field
Crops
­
NAFTA
Syngenta
Seeds,
Inc.
­
Vegetables
­
NAFTA
P.
O.
Box
12257
600
N.
Armstrong
Place
Research
Triangle
Park,
NC
27709­
2257
Boise,
Idaho
83704
2.
MON810,
Cry1Ab
Bt
Corn
OPP
Chemical
Code:
006430
Pesticide
Name:
Bacillus
thuringiensis
Cry1Ab
Delta­
Endotoxin
and
the
Genetic
Material
Necessary
for
Its
Production
in
Corn
Trade
and
Other
Names:
MON
810,
Yieldgard
®
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I21
Uses:
Full
Commercial
Use
in
Field
Corn
Registrant:
Monsanto
Company
700
Chesterfield
Parkway
North
St.
Louis,
MO
63198
3.
TC1507,
Cry1F
Bt
corn
OPP
Chemical
Code:
006481
Pesticide
Name:
Bacillus
thuringiensis
subspecies
Cry1F
Protein
and
the
Genetic
Material
Necessary
for
Its
Production
(
Plasmid
Insert
PHI
8999)
in
Corn
Trade
and
Other
Names:
Herculex
 
I
Insect
Protection,
Pioneer
Brand
Seed
Corn
with
Herculex
 
I
Applicants:
Mycogen
Seeds
c/
o
Dow
Agrosciences
LLC
9330
Zionsville
Road
Indianapolis,
IN
46268­
1054
Pioneer
Hi­
Bred
International,
Inc.
7250
NW
62nd
Avenue
P.
O.
Box
552
Johnston,
Iowa
50131­
0552
Uses:
Full
Commercial
Use
in
Field
Corn
C.
Bt
Cotton
Plant­
incorporated
protectants
Cry1Ac
Bt
Cotton
OPP
Chemical
Code:
006445
Pesticide
Name:
Bacillus
thuringiensis
kurstaki
Delta­
Endotoxin
as
Produced
by
the
Cry1Ac
Gene
and
Its
Controlling
Sequences
as
Expressed
in
Cotton.

Trade
and
Other
Names:
BollGard
®
Uses:
Full
Commercial
Use
in
Cotton
with
Geographic
Limitations
Due
to
Weedy
Relatives
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I22
Target
Pest(
s):
Cotton
bollworm,
tobacco
budworm
&
pink
bollworm
Registrant:
Monsanto
Company
700
Chesterfield
Parkway
North
Saint
Louis,
Missouri
63198
D.
Bt
Potato
Plant­
incorporated
protectants
Cry3A
Bt
Potato
OPP
Chemical
Code:
006432
Pesticide
Name:
Bacillus
thuringiensis
Cry3A
Delta­
Endotoxin
and
the
Genetic
Material
Necessary
for
its
Production
in
Potato
Trade
and
Other
Names:
NewLeaf
®
Uses:
Full
Commercial
Use
in
Potatoes
Target
Pest(
s):
Colorado
Potato
Beetle
Registrant:
Monsanto
Company
700
Chesterfield
Parkway
North
Saint
Louis,
Missouri
63198
E.
Bt
Plant­
incorporated
protectants
Use,
Registration
Approval
History,
and
Tolerance
Listings
1.
Use
History
a)
Bt
Corn
EPA
estimates
adoption
of
Bt
field
corn
was
0.4
million
acres
(
1%)
in
1996,
4.4
million
acres
(
6%)
in
1997,
14.5
million
acres
(
18%)
in
1998,
19.8
million
acres
(
26%)
in
1999,
and
19.5
million
acres
(
25%)
in
2000,
the
last
year
for
which
EPA
has
firm
data.

The
following
map
was
provided
to
the
Agency
by
the
Agricultural
Biotechnology
Stewardship
Technical
Committee
(
2000),
from
data
compiled
by
FSI,
Inc.
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I23
b)
Bt
Cotton
The
Bollgard
acreage
and
percent
of
cotton
acreage
planted
to
Bollgard
(
provided
by
Monsanto
in
its
annual
sales
reports)
from
1996­
2000
is
summarized
on
a
state­
by­
state
level
below.
The
1996­
2001
Beltwide
Cotton
Insect
Loss
Reports
produced
by
Mississippi
State
provide
additional
detailed
use
data
and
are
found
at
http://
www.
msstate.
edu/
Entomology/
Cotton.
html.

Bollgard
acreage
in
each
state
1996­
2000
State
Bollgard
®
Acreage
1996
1997
1998
1999
2000
Alabama
348,810
251,784
306,535
398,683
314,500
Arizona
53,290
175,537
207,713
197,911
210,245
Arkansas
166,881
113,490
111,818
173,652
294,364
California
618
9,868
29,129
91,705
54,584
Florida
52,836
55,030
53,377
45,249
48,974
Georgia
375,744
533,340
508,842
693,288
580,908
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
State
Bollgard
®
Acreage
1996
1997
1998
1999
2000
I24
Kansas
­
­
­
­
1,056
Louisiana
157,411
202,080
244,616
382,839
450,076
Mississippi
443,986
410,333
506,149
746,163
800,775
Missouri
498
592
519
6,254
21,415
New
Mexico
393
2,693
20,869
12,263
12,242
North
Carolina
20,519
21,027
77,490
274,312
424,880
Oklahoma
11,772
7,103
11,459
69,545
90,925
South
Carolina
53,864
91,891
71,894
176,149
128,684
Tennessee
10,833
17,431
57,649
390,245
380,453
Texas
98,819
186,654
276,520
458,694
570,410
Virginia
86
37
1,876
6,300
24,857
U.
S.
Total
1,796,390
2,078,890
2,486,493
3,585,437
4,409,348
c.
Bt
Potato
Although
no
specific
reporting
requirements
were
required
as
part
of
this
registration
in
1995,
EPA
recommended
the
continued
development
of
a
data
base
to
monitor
the
use
of
the
genetically
modified
potatoes
and
correlate
possible
resistant
reports
with
the
use
sites.
Based
on
three­
year
averages,
about
1
million
acres
of
fall
potatoes
are
planted
in
the
U.
S.
annually.
According
to
information
provided
in
Monsanto/
NatureMark's
annual
status
reports
and
meetings
with
the
Agency,
about
10,000
A
(
or
1%
of
the
total)
in
1996
and
25,000
A
(
or
2.5%
of
the
total)
in
1997
were
planted
in
Bt
potatoes
(
marketed
as
NewLeaf
®
Russet
Burbank
and
NewLeaf
®
Superior
and
NewLeaf
®
Atlantic
varieties)
in
the
U.
S.

Acreage
information
was
gathered
from
94
of
112
total
customers
in
1996.
The
proportion
of
NewLeaf
®
potatoes
on
these
farms
ranged
from
0.1%
to
69%
of
total
potato
acreage.
Farm
size
ranged
from
less
than
500
to
5000
acres.
About
50,000
acres
(<
4%)
of
Bt
potatoes
were
planted
in
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I25
1998
and
1999.
Bt
potatoes
were
marketed
as
NewLeaf
®
Russet
Burbank,
Superior,
Atlantic,
and
Shepody
varieties.
About
5,000
acres
(<
0.4%)
of
NewLeaf
®
Bt
potatoes
were
planted
in
2000.

2.
Registration
and
New
Use
Approval
History
Date
Bt
Crop
Company
EPA
Reg.
No(
s)

March
1995
­
Seed
Increase
May
1995
­
Full
Commercial
(
No
expiration
date)
Cry3A
Potatoes
Monsanto
524­
474
March
1995
­
Seed
Increase
August
1995
­
Full
Commercial
Note:
Registration
Expired
4/
1/
01.
Event
176
Cry1Ab
Field
Corn
Syngenta
66736­
1
March
1995
­
Seed
Increase
August
1995
­
Full
Commercial
Note:
Registration
Expired
6/
30/
01.
Event
176
Cry1Ab
Field
Corn
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC
68467­
1
March
1998
­
Full
Commercial
Note:
Registration
Expired
4/
1/
01.
Event
176
Cry1Ab
Popcorn
Syngenta
66736­
1
May
1995
­
Seed
Increase
October
1995
­
Full
Commercial
September
2001
­
Reassessed
Full
Commercial
Cry1Ac
Cotton
Monsanto
524­
478
May
1996
­
Seed
Increase
August
1996
­
Full
Commercial
October
2001
­
Reassessed
Full
Commercial
Bt
11
Cry1Ab
Field
Corn
Syngenta
67979­
1
February
1998
­
Full
Commercial
October
2001
­
Reassessed
Full
Commercial
Bt
11
Cry1Ab
Sweet
Corn
Syngenta
65269­
1
May
1996
­
Seed
Increase
December
1996
­
Full
Commercial
October
2001
­
Reassessed
Full
Commercial
MON810
Cry1Ab
Corn
Monsanto
524­
489
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I26
May
1996
­
Seed
Increase
Note:
MON
801
Registration
Voluntarily
Cancelled
May
1998
MON
801
Cry1Ab
Corn
Monsanto
524­
492
March
1997
­
Full
Commercial
Note:
Registration
Voluntarily
Cancelled
12/
20/
2000.
Cry1Ac
Corn
DeKalb/
Monsanto
69575­
2
May
1998
­
Full
Commercial
for
feed
use
only.
Note:
Registration
Voluntarily
Cancelled
2/
20/
01.
Cry9C
Corn
Aventis
CropScience
USA
LP
264­
669
May
2001
­
Full
Commercial
October
2001
­
Reassessed
Full
Commercial
Cry1F
Corn
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC
68467­
2
May
2001
­
Full
Commercial
October
2001
­
Reassessed
Full
Commercial
Cry1F
Corn
Pioneer
Hi­
Bred
International
Inc./
DuPont
29964­
3
3.
Food
Clearances/
Tolerance
Exemptions
By
this
reassessment,
EPA
has
completed
its
tolerance
reassessment
for
Cry1Ab
(
180.1173)
and
for
Cry3A
(
180.1147)
under
408(
q)
of
the
FFDCA.
The
tolerance
exemptions
for
Cry1Ac
(
180.1155)
and
Cry1F
(
180.1217)
do
not
require
reassessment
at
this
time.
The
following
tolerance
exemptions
allow
the
use
of
the
listed
plant­
incorporated
protectants
in
food
and/
or
feed.

a)
Bacillus
thuringiensis
Cry3A
delta­
endotoxin
and
the
genetic
material
necessary
for
its
production
are
exempted
from
the
requirement
of
a
tolerance
when
used
as
a
plantincorporated
protectant
in
potatoes.
[
40
CFR
180.1147;
60
FR
21728,
May
3,
1995]

b)
Bacillus
thuringiensis
subspecies
kurstaki
Cry1Ac
delta­
endotoxin
and
the
genetic
material
necessary
for
its
production
in
all
plants
are
exempt
from
the
requirement
of
a
tolerance
when
used
as
plant­
incorporated
protectants
in
all
plant
raw
agricultural
commodities.[
40
CFR
180.1155;
62
FR
17722,
Apr.
11,
1997]

c)
Bacillus
thuringiensis
Cry1Ab
delta­
endotoxin
and
the
genetic
material
necessary
for
its
production
in
all
plants
are
exempt
from
the
requirement
of
a
tolerance
when
used
as
plantincorporated
protectants
in
all
plant
raw
agricultural
commodities.
[
40
CFR
180.1173;
61
FR
40343,
Aug
2,
1996]
Bt
Plant­
Incorporated
Protectants
October
15,
2001
Biopesticides
Registration
Action
Document
I27
The
following
tolerance
exemption
is
also
considered
reassessed
because
it
is
included
in
the
more
broad
tolerance
exemption
described
in
(
c)
above.
The
Agency
plans
on
revoking
this
more
narrow
tolerance
exemption
in
the
near
future
in
order
to
reduce
confusion.

Bacillus
thuringiensis
Cry1Ab
delta­
endotoxin
and
the
genetic
material
necessary
for
its
production
(
plasmid
vector
pCIB4431)
in
corn
is
exempt
from
the
requirement
of
a
tolerance
when
used
as
a
plant­
incorporated
protectant
in
the
raw
agricultural
commodities
of
field
corn,
sweet
corn,
and
popcorn.
[
40
CFR
180.1152;
60
FR
42446,
Aug.
16,
1995]

d)
Bacillus
thuringiensis
Cry1F
protein
and
the
genetic
material
necessary
for
its
production
in
corn
is
exempt
from
the
requirement
of
a
tolerance
when
used
as
a
plant­
incorporated
protectant
in
the
food
or
feed
commodities
of
field
corn,
sweet
corn,
and
popcorn.
[
40
CFR
180.1217;
66
FR
30321,
June
6,
2001]
