Document ID: EPA-HQ-OPP-2003-0154-0001
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 Proteins and the Genetic Material Necessary for their Production in Corn; Temporary Exemption from the Requirement of a Tolerance
Posted Date: 2003-07-07T04:00Z

40178
Federal
Register
/
Vol.
68,
No.
129
/
Monday,
July
7,
2003
/
Rules
and
Regulations
N,
079
°
55.25 
W;
32
°
48.2 
N,
079
°
54.35 
W.
(
2)
Another
temporary
fixed
security
zone
is
established
for
the
waters
around
the
Interstate
526
Bridge
spans
(
Don
Holt
Bridge)
in
Charleston
Harbor
and
on
the
Cooper
River
and
will
encompass
all
waters
within
a
line
connecting
the
following
points:
32
°
53.49 
N,
079
°
58.05 
W;
32
°
53.42 
N,
079
°
57.48 
W;
32
°
53.53 
N,
079
°
58.05 
W;
32
°
53.47 
N,
079
°
57.47 
W.
(
b)
Regulations.
In
accordance
with
the
general
regulations
in
§
165.33
of
this
part,
vessels
are
allowed
to
transit
through
these
zones
but
are
prohibited
from
mooring,
anchoring,
or
loitering
within
these
zones
unless
specifically
authorized
by
the
Captain
of
the
Port.
(
c)
Authority.
In
addition
to
33
U.
S.
C.
1321,
the
authority
for
this
section
includes
33
U.
S.
C.
1226.
(
d)
Effective
period.
This
section
is
effective
from
12
midnight
on
July
15,
2003,
until
11:
59
p.
m.
January
15,
2004.

Dated:
June
16,
2003.
Gary
W.
Merrick,
Commander,
Coast
Guard,
Captain
of
the
Port.
[
FR
Doc.
03
 
16969
Filed
7
 
3
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0154;
FRL
 
7310
 
1]

Bacillus
thuringiensis
Cry34Ab1
and
Cry35Ab1
Proteins
and
the
Genetic
Material
Necessary
for
their
Production
in
Corn;
Temporary
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
thuringiensis
Cry34Ab1
and
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production
in
corn
on
corn
when
applied/
used
as
a
plant­
incorporated
protectant.
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
the
temporary
tolerance
exemption.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
thuringiensis
Cry34Ab1
and
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production
in
corn.
The
temporary
tolerance
exemption
will
expire
on
April
30,
2006.
DATES:
This
regulation
is
effective
July
7,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0154,
must
be
received
by
EPA
on
or
before
September
5,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.

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

SUPPLEMENTARY
INFORMATION:

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

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

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0154.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
March
7,
2003
(
68
FR
11100)
(
FRL
 
7285
 
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
0G6112)
by
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC,
9330
Zionsville
Road,
Indianapolis,
IN
46268
 
1054.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC.
The
docket,
OPP
 
2002
 
0350,
cited
in
the
notice
contained
the
petition.
However,
the
administrative
pesticide
petition
number
cited
in
the
notice
(
PP
0G6112)
was
incorrect.
The
correct
number
is
PP
1G6279.
There
was
one
comment
received
in
response
to
the
notice
of
filing
by
the
Center
for
Science
in
the
Public
Interest
(
CSPI).

Summary
of
Comment
The
major
focus
of
the
comments
from
CSPI
is
on
the
results
of
tests
done
to
establish
the
sensitivity
of
the
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2003
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40179
Federal
Register
/
Vol.
68,
No.
129
/
Monday,
July
7,
2003
/
Rules
and
Regulations
Cry34Ab1
protein
to
pepsin
degradation.
CSPI
contests
the
interpretation
of
the
results
provided
by
Dow
AgroSciences
that
indicate
the
Cry34Ab1
degrades
under
the
influence
of
pepsin.
CSPI
asserts
that
EPA
cannot
make
a
safety
determination
in
light
of
these
results
and
international
consensus
on
how
to
address
allergenicity
as
stated
in
the
Food
and
Agricultural
Organization/
World
Health
Organization
(
FAO/
WHO)
expert
consultation.
Specifically,
CSPI
claims
use
of
a
less
sensitive
protein
detection
method,
a
pH
of
1.2
instead
of
2.0
for
the
pepsin
buffer
solution
and
a
low
concentration
of
the
Cry34Ab1
protein
in
the
assays
were
all
utilized
to
achieve
the
results.
CSPI
suggests
that
all
these
features
combine
to
artificially
skew
the
results
of
the
pepsin
assay
to
show
that
Cry
34Ab1
is
readily
broken
down
by
pepsin.
CSPI
suggests
that
the
Cry34Ab1
protein
is
stable
to
gastric
fluid
breakdown
since
it
is
visible
on
Coomassie
blue
stained
gels
at
7
to
10
minutes
of
pepsin
incubation.
CSPI
also
claims
that
the
initial
Dow
AgroScience
data
using
a
more
sensitive
Western
blot
assay
clearly
show
the
protein
present
at
the
20
to
30
minute
sample
and
that
this
endpoint
is
scientifically
agreed
upon
to
indicate
resistance
to
pepsin
degradation.
CSPI
recognizes
that
the
total
dietary
exposure
to
the
Cry34Ab1
protein
likely
to
occur
during
an
experimental
use
permit
would
not
be
expected
to
induce
an
allergic
reaction
and
that
there
is
still
considerable
scientific
controversy
around
the
determination
of
potential
allergenicity
of
a
protein
new
to
the
food
supply.
Finally,
CSPI
states
that
a
test
to
determine
potential
allergenicity
is
still
needed
and,
in
the
interim,
acceptable
standards
for
performing
the
currently
available
tests
are
provided
by
the
FAO/
WHO
report
on
Evaluation
of
Allergenicity
of
Genetically
Modified
Foods
(
Rome,
2001).

EPA
Response
EPA
agrees
that
there
is
still
the
need
to
develop
definitive
tests
to
assess
potential
allergenicity
and
that
the
currently
employed
tests
need
to
follow
standardized
procedures.
EPA
also
agrees
that
no
single
criterion
of
those
currently
utilized
can
alone
be
an
indication
of
potential
allergenicity.
However,
EPA
would
suggest
that,
while
the
guidance
given
by
the
2001
FAO/
WHO
report
is
invaluable,
there
is
still
no
consensus
on
how
to
implement
several
of
the
tests
suggested
in
the
FAO/
WHO
guidance
nor
any
direction
given
as
to
critical
endpoints
for
the
tests
suggested.
This
lack
of
consensus
was
confirmed
by
a
CODEX
ad
hoc
working
group
on
allergenicity
which
met
in
Vancouver,
Canada
in
September
2001,
to
consider
the
advice
of
the
FAO/
WHO
expert
consultation
report
from
Rome
2001.
This
CODEX
group
found
that,
without
development
and
implementation
of
the
new
tests
suggested
by
FAO/
WHO
expert
consultation,
the
current
weight
of
evidence
approach
provides
essentially
the
same
information
for
judging
allergenicity
as
that
suggested
by
the
2001
FAO/
WHO
report.
This
advice
has
been
incorporated
into
the
latest
version
of
the
CODEX
food
safety
assessment
for
genetically
engineered
foods.
(
CODEX,
ftp://
ftp.
fao.
org/
codex/
alinorm03/
Al03
l
34e.
pdf)
The
current
criteria
used
by
EPA
to
judge
allergenicity
include
amino
acid
sequence
similarity
analyses,
stability
to
heat,
and
enzymatic
degradation.
The
Cry34Ab1
protein
does
not
share
significant
amino
acid
similarity
with
known
allergens
either
on
a
whole
sequence
level
or
on
the
eight
amino
acid
stepwise
comparisons,
nor
does
the
Cry34Ab1
protein
appear
to
be
stable
to
temperatures
above
90
°
C.
The
initial
data
reported
from
the
company
indicated
that
one
of
the
two
proteins,
Cry34Ab1,
was
moderately
resistant
to
the
action
of
pepsin
by
still
being
detectable
on
an
SDS­
PAGE
western
blot
at
20
 
30
minutes.
EPA
questioned
the
results
found
in
the
initial
submission
on
pepsin
degradation
and
requested
more
information.
In
the
absence
of
a
definitive
endpoint
for
determining
the
pepsin
resistance
of
a
given
protein,
the
initial
results
reported
by
Dow
were
not
conclusive.
The
2001
Rome
FAO/
WHO
expert
consultation
report
specifically
does
not
mention
a
time
endpoint
for
pepsin
degradation
of
a
protein
other
than
the
protein
or
a
significant
sized
fragment
being
present
at
the
final
endpoint
of
60
minutes.
The
literature
references
CSPI
itself
provided
cite
a
range
of
values
for
pepsin
stability
ranging
from
8
minutes
to
2
hours
and
demonstrate
a
lack
of
consensus
on
pepsin
resistance.
EPA
would
therefore
disagree
with
CSPI
that
there
is
a
scientific
consensus
on
visible
protein
bands
in
an
SDS
PAGE
assay
at
20
to
30
minutes
indicating
pepsin
stability.
Dow
AgroScience's
second
submission
presents
results
that
indicate
more
rapid
breakdown
than
the
initial
data.
Dow
AgroScience's
approach
where
enzymatic
degradation
is
expressed
as
a
kinetic
rate
instead
of
a
definitive
substrate
disappearance
endpoint
makes
the
results
less
variable
since
the
sensitivity
of
the
detection
system
does
not
affect
the
final
result.
This
is
because
the
pepsin
activity
can
be
expressed
as
a
rate
constant,
an
endpoint
that
is
not
dependent
on
the
sensitivity
of
the
detection
system,
is
substrate
concentration
independent
and
is
the
classical
method
used
by
protein
chemists
to
determine
enzyme
activity
or
in
this
case
substrate
disappearance.
While
this
method
may
not
be
the
final
iteration
of
the
pepsin
degradation
assay,
EPA
believes
that
an
analysis
that
lessens
assay
variability
and
makes
the
results
independent
of
the
sensitivity
of
the
detection
method
is
an
improvement.
EPA
finds
that
the
literature
references
CPSI
cited
are
diametrically
opposed
in
their
view
of
the
usefulness
of
the
pepsin
degradation
assay
for
prediction
of
allergenicity
(
Ref.
1).
The
Astwood
et
al.
paper
shows
that,
while
lowering
the
pepsin
concentration
can
lead
to
the
appearance
of
fragments
in
an
otherwise
rapidly
degraded
protein,
the
pepsin
assay
is
a
good
predictor
of
allergenicity
(
Ref.
1).
The
Fu
et
al.
paper
indicates
that
both
allergens
and
nonallergens
can
be
stable
to
pepsin
activity
so
the
assay
is
not
predictive
(
Ref.
2).
Both
papers
emphasize
that
protein
doses,
pepsin
concentrations,
and
assay
conditions
should
be
equivalent
when
comparing
proteins.
Neither
paper
suggests
a
definitive
timepoint
that
could
be
interpreted
as
indicating
protein
stability
to
pepsin.
The
Fu
et
al.
paper
in
fact
suggests
that
allergens
and
non­
allergens
can
both
be
either
resistant
to
or
degraded
by
pepsin.
The
final
conclusion
in
the
Fu
paper
is
that
the
pepsin
sensitivity
assay
alone
has
no
predictive
value
for
allergenicity.
EPA
does
not
agree
with
this
position
but
does
agree
that
pepsin
stability
alone
is
not
a
sole
criterion
to
be
used
for
an
allergenicity
assessment.
EPA
agrees
with
CSPI
that
the
tests
used
to
determine
potential
allergenicity
need
standardization
and
supports
efforts
in
that
area.
EPA
believes
that
there
is
sufficient
data
available,
considering
all
information
on
the
Cry34Ab1
protein,
to
make
a
finding
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
to
the
Cry34Ab1
and
Cry35
Ab1
proteins
as
expressed
in
corn.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
plant­
incorporated
protectants
Bacillus
thuringiensis
Cry34Ab1/
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production
in
corn
in
or
on
corn.
The
Mycogen/
Dow
AgroSciences
and
Pioneer
Hi­
Bred
experimental
use
permits
associated
with
the
petition
are
68467
 
EUP
 
3,
68467
 
EUP
 
5,
68467
 
EUP
 
T(
7),
68467
 
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No.
129
/
Monday,
July
7,
2003
/
Rules
and
Regulations
EUP
 
I(
8),
29964
 
EUP
 
1,
29964
 
EUP
 
3,
29964
 
EUP
 
U(
4),
and
29964
 
EUP
 
L(
5)
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
exemption
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Additionally,
section
408(
b)(
2)(
D)
of
the
FFDCA
requires
that
the
Agency
consider
``
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.

III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness
and
reliability
and
the
relationship
of
this
information
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
Data
have
been
submitted
demonstrating
the
lack
of
mammalian
toxicity
at
high
levels
of
exposure
to
pure
Cry34Ab1/
Cry35Ab1
proteins.
These
data
demonstrate
the
safety
of
the
products
at
levels
well
above
maximum
possible
exposure
levels
that
are
reasonably
anticipated
in
the
crops.
This
is
similar
to
the
Agency
position
regarding
toxicity
and
the
requirement
of
residue
data
for
microbial
pesticides.
See
40
CFR
158.740(
b)(
2)(
i).
For
microbial
products,
further
toxicity
testing
and
residue
data
are
triggered
by
significant
acute
effects
in
studies
such
as
the
mouse
oral
toxicity
study,
to
verify
the
observed
effects
and
clarify
the
source
of
these
effects
(
Tiers
II
and
III).
The
acute
oral
toxicity
data
submitted
support
the
prediction
that
the
Cry34Ab1
and
Cry35Ab1
proteins
would
be
non­
toxic
to
humans.
The
test
substance
was
administered
to
five
female
and
five
male
mice
(
5,000
milligrams/
kilogram
(
mg/
kg)
body
weight))
in
a
1:
4.6
mixture
of
the
two
proteins,
14
kDa
and
44
kDa.
A
single
dose
gavage
(
25
milliliter/
kilogram
(
mL/
kg))
delivered
as
a
20%
mixture
in
0.5%
methycellulose.
All
animals
survived
the
2
 
week
study.
One
female
mouse
exhibited
protruding
or
bulging
eyes
on
days
6
and
7,
but
this
resolved
thereafter.
This
observation
was
not
attributed
to
the
treatment
as
it
was
an
isolated
observation
(
i.
e.,
no
other
animals
exhibited
this).
No
other
clinical
signs
were
noted
for
any
animals
during
the
study.
An
initial
weight
loss
was
observed
in
two
mice
at
test
days
1
and
2,
but
both
gained
weight
for
the
remainder
of
the
study.
All
other
animals
gained
weight
throughout
the
study.
No
gross
treatment
related
observations
were
recorded
during
the
study
as
represented
by
gross
pathologic
observations.
An
acute
oral
LD50
was
calculated
for
this
study
based
upon
a
dosage
of
a
1:
4.6
ratio
mixture
of
Cry34Ab1
(
54%
pure)
and
Cry35Ab1
(
37%
pure)
proteins
at
greater
than
5,000
mg/
kg,
and
greater
than
2,000
mg/
kg
for
an
equimolar
mixture
(
1:
3)
of
the
pure
proteins.
When
proteins
are
toxic,
they
are
known
to
act
via
acute
mechanisms
and
at
very
low
dose
levels
(
Ref.
3).
Therefore,
since
no
acute
effects
were
shown
to
be
caused
by
the
plantincorporated
protectants,
even
at
relatively
high
dose
levels,
the
Cry34Ab1
and
Cry35Ab1
proteins
are
not
considered
toxic.
Since
Cry34Ab1
and
Cry35Ab1
are
proteins,
allergenic
sensitivities
were
considered.
Current
scientific
knowledge
suggests
that
common
food
allergens
tend
to
be
resistant
to
degradation
by
heat,
acid,
and
proteases,
may
be
glycosylated
and
present
at
high
concentrations
in
the
food.
Data
have
been
submitted
that
demonstrate
that
the
Cry34Ab1
and
Cry35Ab1
proteins
are
rapidly
degraded
by
gastric
fluid
in
vitro
and
are
non­
glycosylated.
Two
in
vitro
digestibility
studies
were
conducted
to
determine
the
lability
of
the
Cry34Ab1
and
Cry35Ab1
proteins
in
an
acid
environment
containing
pepsin.
In
the
first
in
vitro
digestibility
study,
1
microgram
(
µ
g)
of
the
14
kDa
protein
(
Cry34Ab1)
were
loaded
and
was
visible
on
the
SDS­
PAGE
gel
up
to
the
15
minute
sample
point
and
on
the
Western
blot,
which
has
greater
sensitivity,
up
to
the
20
minute
time
point.
Two
micrograms
of
the
44
kDa
protein
(
Cry35Ab1)
was
loaded
on
the
SDS
gel.
A
single
band
was
observed
on
the
44
kDa
SDS­
PAGE
at
approximately
15
to
16
kDa.
Western
blot
bands
were
observed
at
approximately
42
kDa
and
14
kDa.
These
bands
were
only
observed
at
the
one
minute
time
point,
but
not
afterwards.
It
was
concluded
that
both
proteins
are
susceptible
to
degradation
in
the
simulated
gastric
environment,
but
that
the
Cry35Ab1
was
more
rapidly
degraded.
In
the
second
in
vitro
digestibility
study,
the
digestibility
of
Cry34Ab1
was
further
investigated
and
enzyme
kinetics
were
used
in
evaluating
the
data.
In
this
study,
0.36
µ
g
of
the
protein
was
loaded
in
the
SDS
gel.
The
protein
appears
to
have
approached
full
degradation
by
7.5
minutes.
Volumes
remaining
at
the
10
and
15
minute
time
points
were
excluded
from
the
calculations
since
they
were
below
background
levels.
Using
this
first
order
decay
model,
the
DT50
and
DT90
for
this
protein
in
the
simulated
gastric
fluid
GF
were
estimated
to
be
1.9
and
6.2
minutes,
respectively.
The
Cry34Ab1
protein
is
rapidly
degraded
in
the
simulated
gastric
fluid
using
this
assay
and
detection
methodology.
The
conditions
of
the
assay
are
biologically
appropriate
in
temperature,
pH,
and
chemical
makeup
of
the
digestive
solution.
The
first
order
decay
rate
kinetics
accurately
portray
the
digestion
of
Cry34Ab1.
Submitted
studies
regarding
heat
stability
of
the
Cry34Ab1
and
Cry35Ab1
proteins
demonstrate
that
these
proteins
are
inactivated
at
 
90
°
C
and
 
60
°
C,
respectively.
A
comparison
of
amino
acid
sequences
of
known
allergens
uncovered
no
evidence
of
any
homology
with
Cry34Ab1
or
Cry35Ab1,
even
at
the
level
of
8
contiguous
amino
acids
residues.
The
potential
for
the
Cry34Ab1
and
Cry35Ab1
proteins
to
be
food
allergens
is
minimal.
Regarding
toxicity
to
the
immune
system,
the
acute
oral
toxicity
data
submitted
support
the
prediction
that
the
Cry34Ab1
and
Cry35Ab1
proteins
would
be
non­
toxic
to
humans.
When
proteins
are
toxic,
they
are
known
to
act
via
acute
mechanisms
and
at
very
low
dose
levels
(
Ref.
3).
Therefore,
since
no
effects
were
shown
to
be
caused
by
the
plant­
incorporated
protectants,
even
at
relatively
high
dose
levels,
the
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Vol.
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129
/
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7,
2003
/
Rules
and
Regulations
Cry34Ab1
and
Cry35Ab1
proteins
are
not
considered
toxic.

IV.
Aggregate
Exposures
In
examining
aggregate
exposure,
section
408
of
the
FFDCA
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).

Dietary
Exposure
Exposure
via
the
skin
or
inhalation
is
not
likely
since
the
plant­
incorporated
protectant
is
contained
within
plant
cells,
which
essentially
eliminates
these
exposure
routes
or
reduces
these
exposure
routes
to
negligible.
Oral
exposure,
at
very
low
levels,
may
occur
from
ingestion
of
processed
corn
products
and,
potentially,
drinking
water.
However
a
lack
of
mammalian
toxicity
and
the
digestibility
of
the
plant­
incorporated
protectants
have
been
demonstrated.
The
use
sites
for
the
Cry34Ab1
and
Cry35Ab1
proteins
are
all
agricultural
for
control
of
insects.
Therefore,
exposure
via
residential
or
lawn
use
to
infants
and
children
is
not
expected.
Even
if
negligible
exposure
should
occur,
the
Agency
concludes
that
such
exposure
would
present
no
risk
due
to
the
lack
of
toxicity
demonstrated
for
the
Cry34Ab1
and
Cry35Ab1
proteins.

V.
Cumulative
Effects
Pursuant
to
FFDCA
section
408(
b)(
2)(
D)(
v),
EPA
has
considered
available
information
on
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
included
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
with
a
common
mechanism
of
toxicity.
Because
there
is
no
indication
of
mammalian
toxicity
to
these
plantincorporated
protectants,
we
conclude
that
there
are
no
cumulative
effects
for
the
Cry34Ab1
and
Cry35Ab1
proteins.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
A.
Toxicity
and
Allergenicity
Conclusions
The
data
submitted
and
cited
regarding
potential
health
effects
for
the
Cry34Ab1
and
Cry35Ab1
proteins
include
the
characterization
of
the
expressed
Cry34Ab1
and
Cry35Ab1
proteins
in
corn,
as
well
as
the
acute
oral
toxicity,
heat
stability,
and
in
vitro
digestibility
of
the
proteins.
The
results
of
these
studies
were
determined
applicable
to
evaluate
human
risk
and
the
validity,
completeness,
and
reliability
of
the
available
data
from
the
studies
were
considered.
Adequate
information
was
submitted
to
show
that
the
Cry34Ab1
and
Cry35Ab1
test
materials
derived
from
microbial
cultures
were
biochemically
and
functionally
similar
to
the
protein
produced
by
the
plant­
incorporated
protectant
ingredients
in
corn.
Production
of
microbially
produced
protein
was
chosen
in
order
to
obtain
sufficient
material
for
testing.
The
acute
oral
toxicity
data
submitted
support
the
prediction
that
the
Cry34Ab1
and
Cry35Ab1
proteins
would
be
non­
toxic
to
humans.
When
proteins
are
toxic,
they
are
known
to
act
via
acute
mechanisms
and
at
very
low
dose
levels
(
Ref.
3).
Since
no
treatmentrelated
adverse
effects
were
shown
to
be
caused
by
Cry34Ab1
and
Cry35Ab1
proteins,
even
at
relatively
high
dose
levels
(
greater
than
5,000
mg/
kg
based
upon
a
dosage
of
a
1:
4.6
ratio
mixture
of
(
54%
pure)
Cry34Ab1
and
(
37%
pure)
Cry35Ab1
proteins
and
greater
than
2,000
mg/
kg
for
an
equimolar
mixture
(
1:
3)
of
the
pure
proteins),
the
Cry34Ab1
and
Cry35Ab1
proteins
are
not
considered
toxic.
This
is
similar
to
the
Agency
position
regarding
toxicity
and
the
requirement
of
residue
data
for
the
microbial
Bacillus
thuringiensis
products
from
which
this
plantincorporated
protectant
was
derived.
See
40
CFR
158.740(
b)(
2)(
i).
For
microbial
products,
further
toxicity
testing
and
residue
data
are
triggered
by
significant
acute
effects
in
studies
such
as
the
mouse
oral
toxicity
study
to
verify
the
observed
effects
and
clarify
the
source
of
these
effects
(
Tiers
II
and
III).
Although
Cry34Ab1
and
Cry35Ab1
expression
level
data
were
submitted,
residue
chemistry
data
were
not
required
for
a
human
health
effects
assessment
of
the
subject
plantincorporated
protectant
ingredients
because
of
the
lack
of
mammalian
toxicity.
Both:
(
1)
Available
information
concerning
the
dietary
consumption
patterns
of
consumers
(
and
major
identifiable
subgroups
of
consumers
including
infants
and
children);
and
(
2)
safety
factors
which,
in
the
opinion
of
experts
qualified
by
scientific
training
and
experience
to
evaluate
the
safety
of
food
additives,
are
generally
recognized
as
appropriate
for
the
use
of
animal
experimentation
data
were
not
evaluated.
The
lack
of
mammalian
toxicity
at
high
levels
of
exposure
to
the
Cry34Ab1
and
Cry35Ab1
proteins
demonstrates
the
safety
of
the
product
at
levels
well
above
possible
maximum
exposure
levels
anticipated
in
the
crop.
The
genetic
material
necessary
for
the
production
of
the
plant­
incorporated
protectant
active
ingredients
are
the
nucleic
acids
(
DNA,
RNA)
which
comprise
genetic
material
encoding
these
proteins
and
their
regulatory
regions.
The
genetic
material
(
DNA,
RNA)
necessary
for
the
production
of
Cry34Ab1
and
Cry35Ab1
proteins
in
corn
have
been
exempted
under
the
blanket
exemption
for
all
nucleic
acids
(
40
CFR
174.175).

B.
Infants
and
Children
Risk
Conclusions
FFDCA
section
408(
b)(
2)(
C)
provides
that
EPA
shall
assess
the
available
information
about
consumption
patterns
among
infants
and
children,
special
susceptibility
of
infants
and
children
to
pesticide
chemical
residues
and
the
cumulative
effects
on
infants
and
children
of
the
residues
and
other
substances
with
a
common
mechanism
of
toxicity.
In
addition,
FFDCA
section
408(
B)(
2)(
C)
also
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
database
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
there
is
a
finding
of
no
toxicity
for
the
Cry34Ab1
and
Cry35Ab1
protein
and
the
genetic
material
necessary
for
their
production.
Thus,
there
are
no
threshold
effects
of
concern
and,
as
a
result,
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
Further,
the
provisions
of
consumption
patterns,
special
susceptibility,
and
cumulative
effects
do
not
apply.

C.
Overall
Safety
Conclusion
There
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population,
including
infants
and
children,
to
the
Cry34Ab1
and
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
because,
as
discussed
above,
no
toxicity
to
mammals
has
been
observed
for
the
plant­
incorporated
protectants.

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/
Rules
and
Regulations
VII.
Other
Considerations
A.
Endocrine
Disruptors
The
pesticidal
active
ingredients
are
proteins,
derived
from
sources
that
are
not
known
to
exert
an
influence
on
the
endocrine
system.
Therefore,
the
Agency
is
not
requiring
information
on
the
endocrine
effects
of
these
plantincorporated
protectants
at
this
time.

B.
Analytical
Method
A
validated
method
for
extraction
and
direct
enzyme
linked
immunosorbent
assay
analysis
of
Cry34Ab1
in
corn
grain
has
been
submitted
and
found
acceptable
by
the
Agency.

C.
Codex
Maximum
Residue
Level
No
Codex
maximum
residue
levels
exists
for
the
plant­
incorporated
protectants
Bacillus
thuringiensis
Cry34Ab1
and
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production
in
corn.

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

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0154
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
September
5,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VIII.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0154,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?

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

IX.
References
1.
Astwood
J.
D.,
Leach,
J.
N.
and
Fuch,
R.
L.
(
1996)
``
Stability
of
Food
Allergens
to
Digestion
In
Vitro.''
Nature
Biotech.
14:
1269
 
1273.
2.
Fu,
T­
J,
Abbott,
U.
R.,
Hatzos,
C.
(
2002)
``
Digestibility
of
Food
Allergens
and
Nonallergenic
Proteins
in
Simulated
Gastric
Fluid
and
Simulated
Intestinal
Fluid
­
A
Comparative
Study.''
J.
Agric.
Food
Chem.
50:
7154
 
7160.
3.
Sjoblad,
Roy
D.,
et
al.
(
1992)
``
Toxicological
Considerations
for
Protein
Components
of
Biological
Pesticide
Products.''
Regulatory
Toxicology
and
Pharmacology
15L,
3
 
9.

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/
Rules
and
Regulations
X.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
June
23,
2003.

James
Jones,

Director,
Office
of
Pesticide
Programs.

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

PART
180
 
[
AMENDED]

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

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


2.
Section
180.1242
is
added
to
subpart
D
to
read
as
follows:

§
180.1242
Bacillus
thuringiensis
Cry34Ab1
and
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production
in
corn;
temporary
exemption
from
the
requirement
of
a
tolerance.

Bacillus
thuringiensis
Cry34Ab1
and
Cry35Ab1
proteins
and
the
genetic
material
necessary
for
their
production
in
corn
are
temporarily
exempted
from
the
requirement
of
a
tolerance
when
used
as
plant­
incorporated
protectants
in
the
food
and
feed
commodities
of
field
corn,
sweet
corn
and
popcorn.
This
temporary
exemption
from
the
requirement
of
a
tolerance
will
permit
the
use
of
the
food
commodities
in
this
paragraph
when
treated
in
accordance
with
the
provisions
of
the
experimental
use
permits
68467
 
EUP
 
3,
68467
 
EUP
 
5,
68467
 
EUP
 
T(
7),
68467
 
EUP
 
I(
8),
29964
 
EUP
 
1,
29964
 
EUP
 
3,
29964
 
EUP
 
U(
4),
and
29964
 
EUP
 
L(
5)
which
may
be
issued
and
amended/
extended
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended
(
7
U.
S.
C.
136).
This
temporary
exemption
from
the
requirement
of
a
tolerance
expires
and
is
revoked
April
30,
2006.
This
temporary
exemption
from
the
requirement
of
a
tolerance
may
be
revoked
at
any
time
if
the
experimental
use
permit
is
revoked
or
if
any
experience
with
or
scientific
data
on
this
pesticide
indicate
that
the
tolerance
is
not
safe.

[
FR
Doc.
03
 
17105
Filed
7
 
3
 
03;
8:
45
am]

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