Document ID: EPA-HQ-OPP-2002-0328-0001
Agency: epa
Document Type: Rule
Title: Bacillus Pumilus GB 34; Exemption from the Requirement of a Tolerance
Posted Date: 2003-04-02T05:00Z

15958
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Beet,
sugar,
molasses
..............
2.0
Beet,
sugar,
roots
.....................
0.5
Beet,
sugar,
tops
......................
15.0
Grass,
forage
............................
10.0
Grass,
hay
................................
0.2
Spinach
.....................................
0.5
Sunflower,
seed
........................
0.5
Sunflower,
meal
........................
1.0
Tomato
......................................
0.1
*
*
*
*
*
[
FR
Doc.
03
 
7800
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0328;
FRL
 
7286
 
9]

Bacillus
pumilus
GB
34;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
pumilus
GB
34
when
used
as
a
seed
treatment
in
or
on
soybeans
and
soybeans
after
harvest.
Gustafson
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
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
pumilus
GB
34.

DATES:
This
regulation
is
effective
April
2,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0328,
must
be
received
on
or
before
June
2,
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
IX.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Anne
Ball,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8717;
e­
mail
address:
ball.
anne@
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
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111),
e.
g.,
crop
production
 
Industry
(
NAICS
112),
e.
g.,
animal
production
 
Industry
(
NAICS
311),
e.
g.,
food
manufacturing
 
Industry
(
NAICS
32532,
e.
g.,
pesticide
manufacturing
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
 
2002
 
0328.
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.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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.
Once
in
the
system,
select
``
search''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
December
31,
2001
(
66
FR
67522)
(
FRL
 
6813
 
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a(
e),
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
1F6344)
by
Gustafson
LLC,
1400
Preston
Road,
Suite
400,
Plano,
TX
75093.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Gustafson
LLC.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
B.
Pumilus
GB
34.

III.
Risk
Assessment
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
tolerance
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''

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15959
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
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.

IV.
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.
The
Bacillus
pumilus
species
was
first
described
by
Meyer
and
Gottheil
in
1901.
This
naturally
occurring
species
is
one
of
the
most
numerous
Bacillus
sp.
found
on
plant
surfaces.
The
strain
Bacillus
pumilus
GB
34
is
a
naturally
occurring
soil
colonizer.
The
mode
of
action
of
the
strain,
an
anti
fungal
agent,
is
to
colonize
the
developing
root
system
of
the
plant
it
is
to
protect,
in
this
case
the
developing
root
system
of
the
soybean
plant.
The
organism
Bacillus
pumilus
GB
34
then
suppresses
by
competition,
by
the
formation
of
a
physical
barrier,
the
continued
formation
of
spores
of
the
fungal
diseases
such
as
Rhizoctonia
and
Fusarium.
Subsequently
GB
34
colonizes
the
remaining
fungal
disease
spores
themselves,
thereby
destroying
them.
On
the
basis
of
Acute
injection
toxicity/
Pathogenicity
tests
on
rats,
Bacillus
pumilus
GB
34
does
not
appear
to
be
toxic,
infective,
and/
or
pathogenic
in
those
mammals.
Toxicity
studies
submitted
in
support
of
this
tolerance
petition
are
summarized
below.
More
detailed
analyses
of
these
studies
may
be
found
in
the
specific
Agency
reviews
of
the
studies.
Waivers
requested
and
granted
are,
as
well,
noted.
Toxicity
studies
relating
to
the
GB
34
Concentrate
(
End
Use
Product)
and
GB
34
Technical
(
Technical
Grade
Active
Ingredient)
are
as
follows:
1.
Acute
oral
toxicity
 
i.
GB
34
Concentrate.
(
Submitted
to
determine
the
adequacy
of
data
to
support
an
EUP,
GB
34
Concentrate,
and
here,
bridged
to
support
a
section
3
registration
of
the
microbial
product)
(
OPPTS
870.1100;
OPP
152.30;
Master
record
identification
number
(
MRID)
452940
 
01).
Five
male
and
five
female
young
adult
Sprague­
Dawley
rats
each
received
a
single
5,000
milligrams/
kilogram
(
mg/
kg)
gavage
dose
of
GB
34
Concentrate,
previously
diluted
to
a
40%
weight/
weight
(
w/
w)
solution
with
distilled
water
at
a
dosing
volume
of
1
milliliter
(
mL)/
100
grams
(
g).
The
rats
were
observed
for
morbidity,
moribundity,
and
behavioral
changes
1
and
3
hours
after
dosing
and
at
least
daily
thereafter
for
14
days.
They
were
weighed
on
days
0,
7,
and
14.
At
the
end
of
the
study,
the
rats
were
euthanized
by
CO2
inhalation
and
necropsied.
No
morbidity,
moribundity,
or
effects
on
body
weight
were
found
following
treatment
of
rats
with
5,000
mg/
kg
test
material.
Therefore,
the
Sprague
Dawley
rat
oral
lethal
dose
(
LD)
50
of
GB
34
Concentrate
for
male,
female,
and
male
and
female
combined
is
>
5,000
mg/
kg,
placing
the
test
material
in
Toxicity
Category
IV.
ii.
Acute
oral
toxicity
 
GB
34
Technical.
(
OPPTS
870.1100;
OPP
152.30;
MRID
454335
 
01
corrected
as
MRID
457225
 
01).
Five
male
and
five
female
Sprague­
Dawley
rats
each
received
a
single
5,000
mg/
kg
gavage
dose
of
the
GB
34
Technical,
previously
diluted
to
a
40%
w/
w
solution
with
distilled
water,
at
a
dosing
volume
of
1
mL/
100
g.
The
rats
were
observed
for
morbidity,
moribundity,
and
behavioral
changes
1
and
3
hours
after
dosing
and
at
least
daily
thereafter
for
14
days.
They
were
weighed
on
days
0,
7,
and
14.
At
the
end
of
the
study,
the
rats
were
euthanized
by
CO2
inhalation
and
necropsied.
No
morbidity,
moribundity,
or
effects
on
body
weight
were
found
following
treatment
of
rats
with
5,000
mg/
kg
test
material.
Therefore,
the
Sprague
Dawley
rat
oral
LD
50
of
GB
34
Technical
for
male,
female,
and
male
and
female
combined
is
>
5000
mg/
kg,
placing
the
test
material
in
Toxicity
Category
IV.
2.
Acute
dermal
toxicity
 
GB
34
Concentrate
and
GB
34
Technical.
((
OPPTS
870.1200
and
OPPTS
885.
3100
(
Acute
dermal
toxicity/
Pathogenicity);
OPP
152.31;
waiver
request,
no
MRID)).
A
waiver
was
requested
and
granted
for
a
seed
treatment
use.
The
rationale
for
the
waiver
is
that
the
rate
of
application
of
the
product
is
0.1
ounce
(
oz.)
per
100
pounds
(
lbs.)
of
seed.
The
seed
treatment
is
to
take
place
in
a
commercial
seed
treatment
facility
in
which
there
is
no
exposure
to
the
general
population.
After
germination
of
the
treated
seed,
the
habit
of
the
bacterium
is
to
inhabit
the
root
system
of
the
plant.
There
is
expected
to
be
minimal,
if
any,
dermal
exposure
for
the
general
population
in
a
seed
treatment
use
of
the
microbial
pesticide.
3.
Acute
inhalation
toxicity
 
GB
34
Concentrate
and
GB
34
Technical.
((
OPPTS
870.1300
and
OPPTS
885.
3150
(
Acute
pulmonary
toxicity/
Pathogenicity);
OPP
152.32;
waiver
request,
no
MRID)).
A
waiver
was
requested
and
granted
for
a
seed
treatment
use.
The
use
of
GB
34
is
to
be
limited
to
that
of
a
seed
treatment
which
is
to
take
place
in
a
commercial
seed
treatment
facility
in
which
there
is
no
potential
inhalation
exposure
to
the
general
population.
The
rate
of
application
of
the
pesticide
is
0.1
oz.
per
100
lbs.
of
seed.
The
habit
of
the
bacterium
is
to
gravitate
to
the
root
system
of
the
developing
plant.
For
a
seed
treatment
use
of
GB
34
there
will
most
likely
be
a
negligible,
if
any
inhalation
exposure.
4.
Acute
oral
toxicity/
Pathgenicity
 
GB
34
Technical
and
GB
34
Concentrate.
(
OPPTS
885.3050).
A
waiver
was
requested
and
granted
for
a
seed
treatment
use.
The
rationales
such
as
are
the
minimal
increase
of
human
oral
exposure
expected
due
to
the
low
rate
of
application
(
0.1
oz.
per
100
lbs.
of
seed),
the
minimal
exposure
to
the
general
population
since
the
seed
treatment
will
take
place
in
a
commercial
seed
treating
facility
with
mechanical
treating
equipment,
and
the
results
of
the
toxicity
tests
submitted
to
date
(
see
item
1.
ii.)
which
do
not
indicate
that
this
strain
is
toxic
or
infective.
Moreover
the
results
would
suggest
that
the
GB
34
strain
does
not
express
the
6,500
molecular
weight
toxin
discussed
in
two
papers.
See
item
7
below.
In
addition,
the
habit
of
the
bacterium
to
gravitate
to
the
root
system
of
the
developing
plant
makes
it
unlikely
that
any
would
be
present
in
the
above
ground
parts
of
the
mature
plant,
thus
minimizingthe
potential
for
oral
exposure
for
humans.
5.
Primary
eye
irritation
 
i.
GB
34
Concentrate.
((
Submitted
to
determine
the
adequacy
of
data
to
support
an
EUP,
GB
34
Concentrate,
and
here,
bridged
to
support
a
section
3
registration
of
the
microbial
product)
(
OPPTS
870.2400;
OPP
152.35;
MRID
452940
 
02)).
Three
male
and
three
female
young
adult
New
Zealand
white
rabbits
were
used
in
the
experiment.
Prior
to
test
material
instillation,
both
eyes
were
treated
with
2%
fluorescein
and
examined
under
ultraviolet
(
UV)
light
for
ocular
abnormalities.
The
test
material,
0.1
mL
(
equivalent
to
0.05
 
0.07
g),
was
instilled
into
the
everted
lower
lid
of
the
right
eye
and
the
upper
and
lower
lids
held
closed
for
1
second.
The
contralateral
eye
served
as
control.
The
eyes
were
examined
and
scored
acording
to
the
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/
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April
2,
2003
/
Rules
and
Regulations
Draize
method
1,
24,
48
and
72
hours
after
test
material
instillation.
The
24
hour
examination
also
included
a
fluorescein
staining
examination
for
corneal
effects.
All
rabbits
survived
the
study.
All
rabbits
developed
slight
conjunctival
irritation
that
cleared
within
48
hours
of
treatment.
No
corneal
opacity
or
iritis
were
noted.
GB
34
Concentrate
was
minimally
irritating
to
the
eye
and
is
placed
in
Toxicity
Category
IV.
ii.
Primary
eye
irritation
 
GB
34
Technical.
(
OPPTS
870.2400;
OPP
152.35;
MRID
454335
 
02,
corrected
as
457225
 
02).
Three
male
and
three
female
young
adult
New
Zealand
white
rabbits
were,
prior
to
test,
treated
in
both
eyes
with
2%
fluorescein
and
then
examined
under
UV
light
for
ocular
abnormalities.
The
test
material,
in
the
amount
of
0.1
mL,
was
instilled
into
the
everted
lower
lid
of
the
right
eye
and
the
upper
and
lower
lids
were
held
closed
for
1
second.
The
contralateral
eye
served
as
control.
The
eyes
were
examined
and
scored
according
to
the
Draize
method
1,
24,
48
and
72
hours
after
test
material
instillation.
The
24
hour
examination
also
included
a
fluorescein
staining
examination
for
corneal
effects.
All
rabbits
developed
moderate
conjunctival
irritation
that
cleared
up
within
72
hours
of
treatment.
No
corneal
opacity
or
iritis
or
nonocular
effects
were
noted.
The
GB
technical
test
substance
was
mildly
irritating
to
the
eye
and
is
placed
in
Toxicity
Category
III.
6.
Primary
dermal
irritation
 
i.
GB
34
Concentrate.
(
Submitted
to
determine
the
adequacy
of
data
to
support
an
EUP
for
GB
34
Concentrate,
and
here,
bridged
to
support
a
section
3
registration
of
the
microbial
product)
(
OPPTS
870.2500;
OPP
152.34;
MRID
452940
 
03).
Three
male
and
three
female
young
adult
New
Zealand
white
rabbits
were
received
for
the
study.
The
fur
on
the
dorso­
lumbar
area
of
each
rabbit
was
clipped.
The
rabbits
were
given
a
single
0.5
g
dose
of
test
material
applied
under
a
under
a
1
inch
x
1
inch
4­
ply
gauze
pad
on
a
6
cm2
clipped
site.
The
gauze
pad
is
then
secured
and
Elizabethan
collars
were
placed
on
the
animals.
Four
hours
later
these
were
removed
and
the
sites
wiped
with
a
moistened
towel.
The
application
sites
were
observed
for
dermal
irritation
1,
24,
48,
and
72
hours
after
patch
removal.
In
addition
the
rabbits
were
observed
at
least
daily
for
clinical
signs
of
toxicity
during
the
72
 
hour
study
period.
All
rabbits
survived
the
study.
No
dermal
irritation
was
observed
on
any
rabbit
at
any
site.
Based
on
the
study
GB
34
Concentrate
is
nonirritating
to
the
New
Zealand
white
rabbit
and
is
placed
in
Toxicity
Category
IV.
ii.
Primary
dermal
irritation
 
GB
34
Technical.
(
OPPTS
870.2500;
OPP
152.34;
MRID
454335
 
03
corrected
as
MRID
457225
 
03).
Three
male
and
three
female
New
Zealand
albino
rabbits
were
prepared
by
clipping
the
dorsal
area
and
the
trunk.
Only
healthy
animals
without
preexisting
skin
irritation
had
been
selected
for
the
test.
The
test
substance
in
the
amount
of
0.5
g
was
placed
on
a
1
inch
x
1
inch,
4­
ply
gauze
pad
which
was
applied
and
secured
on
each
rabbit.
After
4
hours
exposure
to
the
test
substance,
the
pads
were
removed
and
the
test
sites
gently
wiped
with
water
and
towel
to
remove
any
residual
test
substance.
Individual
dose
sites
were
scored
according
to
the
Draize
scoring
system
at
approximately
1,
24,
48
and
72
hours
after
patch
removal.
The
animals
were
observed
for
signs
of
gross
toxicity
and
behavioral
changes
at
least
once
daily
during
the
test
period.
All
animals
appeared
active
and
healthy.
There
were
no
signs
of
gross
toxicity,
adverse
pharmacologic
effects
or
abnormal
behavior.
No
dermal
irritation
was
noted
at
any
test
site
during
the
study.
Under
the
conditions
of
the
study,
the
GB
34
Technical
is
classified
as
non­
irritating
to
the
skin
and
placed
in
Toxicity
Category
IV.
7.
Acute
injection
toxicity/
Pathogenicity
 
GB
34
Technical.
(
Submitted
to
determine
the
adequacy
of
data
to
support
an
EUP
for
GB
34,
and
here,
bridged
to
support
a
section
3
registration
of
the
microbial
product)
(
OPPTS
885.3200;
OPP
152.33;
MRID
453416
 
01).
A
total
of
39
male
and
39
female
rats
were
used
in
the
tests.
The
results
showed:
i.
Mortality.
No
deaths
were
observed
in
any
of
the
dosed
or
control
groups
prior
to
scheduled
sacrifice.
ii.
Body
and
organ
weights.
Overall,
both
male
and
female
rats
gained
weight
for
the
duration
of
the
study,
demonstrating
the
continued
health
of
the
animals.
iii.
Clinical
Observation.
Overall,
both
male
and
female
rats
showed
no
abnormal
clinical
signs.
iv.
Gross
necropsy.
No
significant
signs
of
abnormalities
were
seen
except
for
a
laceration
on
the
left
shoulder
of
a
test
substance
treated
male
rat.
An
enlarged
spleen
was
seen
in
one
test
substance
treated
male
rat
on
day
The
conclusion
in
the
Data
Evaluation
report
was
that
Bacillus
pumilus
GB
34
does
not
appear
to
be
toxic,
infective,
and/
or
pathogenic
in
rats,
when
dosed
at
1
x
107
cfu/
animal.
This
test
supports
the
requirements
for
both
the
TGAI
(
the
technical)
and
the
end
use
product
(
the
concentrate).
A
hypersensitivity
study,
or
dermal
sensitization
study
(
OPP
152.36)
is
not
required
for
registration
of
this
product
since
the
routes
of
use
will
not
result
``
in
repeated
human
contact
by
inhalation
or
dermal
routes''
as
specified
in
footnote
iii
of
the
table
in
40
CFR
158.740(
c).
Use
of
the
product
is
limited
to
that
of
a
seed
treatment
which
takes
place
in
a
commercial
facility
using
mechanical
seed
treatment
equipment.
An
Immune
response
study
is
not
required
for
registration
of
this
product
because
the
Acute
I.
V.,
I.
C.,
or
I.
P.
Injection
toxicity/
Pathogenicity
study,
(
OPPTS
guideline
885.3200/
OPP
153.33)
submitted
to
determine
the
adequacy
of
data
to
support
an
EUP
for
GB
34,
and
here
bridged
support
a
section
3
registration
of
the
microbial
product,
serves
to
address
the
endpoint
of
immune
response.
This
injection
study
examines
the
normal
functioning
of
the
immune
system
when
faced
with
the
potentially
most
challenging
exposure
to
this
microbial
pesticide
active
ingredient:
Direct
injection
into
the
bloodstream.
If
the
test
animal
is
able
to
withstand
and
survive
the
introduction
of
such
a
large
number
of
microbes,
bypassing
the
normal
protective
barriers
of
the
skin,
the
pulmonary
macrophages
and
the
gastrointestinal
lymphoid
tissues,
then
the
immune
system
is
functioning
normally.
The
normal
functioning
of
the
immune
system
implies
that
it
can
recognize
the
introduced
microbes
as
foreign
and
can
clear
them
from
the
blood
and
other
exposed
organs.
After
the
active
ingredient,
Bacillus
pumilus
GB
34
was
intravenously
injected
into
the
test
animals
(
rats),
no
deaths,
adverse
clinical
signs
or
significant
findings
upon
necropsy
were
seen
35
days
after
the
injection.
(
See
item
7).
The
requirement
for
Tier
II
and
Tier
III
data
was
not
triggered
because
of
the
results
of
Tier
I
data
which
had
been
submitted
or
waived.

V.
Aggregate
Exposures
Section
408(
b)(
2)(
D)(
vi)
of
the
FFDCA
directs
EPA
to
consider
available
information
concerning
aggregate
exposures
to
consumers
(
and
major
identifiable
subgroups
of
consumers)
from
the
pesticide
residue
in
food
and
all
other
non­
occupational
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).

A.
Dietary
Exposure
Bacillus
pumilus
GB
34
is
a
naturally
occurring
soil
microorganism
which
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Vol.
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63
/
Wednesday,
April
2,
2003
/
Rules
and
Regulations
inhabits
the
root
system
of
plants
and
acts
as
an
antifungal
agent.
Review
of
the
available
toxicology
data
submitted
in
support
of
registration
indicate
that
it
is
non­
toxic
and
non­
pathogenic
to
animals
and
humans.
In
its
proposed
use
as
a
soybean
seed
treatment,
it
is
not
foreseen
to
contribute
any
or
more
than
a
negligible
amount
of
dietary
exposure.
1.
Food.
The
product
is
used
only
as
a
seed
treatment
and
the
organism
inhabits
the
roots
of
the
plants,
in
this
case
the
soybean
plant
roots.
The
use
of
products
which
contain
B.
pumilus
GB
34
is
not
anticipated
to
result
in
more
than
negligible,
if
any,
any
dietary
exposure
from
food
for
humans.
To
date
there
have
been
no
reports
of
any
hypersensitivity
incidents
or
reports
of
any
known
adverse
reactions
in
humans
resulting
from
exposure
to
B.
pumilus
GB
34.
2.
Drinking
water
exposure.
There
is
expected
to
be
only
insignificant
or
minimal
human
exposure
to
the
organism
in
drinking
water
from
its
use
in
the
treatment
of
seeds,
its
only
use
proposed.
The
treatment
of
seeds
is
expected
to
take
place
in
a
commercial
seed
treatment
facility.
The
farmer
then
plants
the
seeds
in
the
soil.
Since
the
organism
is
non­
toxic
and
nonpathogenic
to
humans,
even
if
small
amounts
would
seep
into
the
ground
water,
there
is
expected
to
be
no
adverse
effect
on
humans.

B.
Other
Non­
Occupational
Exposure
The
possibility
for
non­
dietary
exposure
to
residues
of
this
B.
pumilus
pesticide
for
the
general
population,
including
infants
and
children,
is
unlikely
because
the
only
proposed
use
site
is
in
an
agricultural
setting,
as
a
treatment
on
soybean
seeds.
Since
the
seed
treatment
is
to
take
place
in
a
commercial
seed
treating
facility
where
mechanical
treating
equipment
is
used,
it
is
not
expected
that
dermal
or
inhalation
exposure
to
residues
will
occur
in
the
general
population,
including
infants
and
children.
Bacillus
pumilus
GB
34
is
a
ubiqutous
bacterium
commonly
found
in
soil,
water,
air
and
decomposing
plant
tissue
and
which
acts
as
an
antifungal
agent.
The
bacteria
typically
occur
at
106
to
107
colony
forming
units
(
CFU's)
per
gram
of
soil.
It
is
not
known
to
be
pathogenic
or
toxic
to
any
animal
or
plant
species.
The
added
soil
density
from
the
proposed
seed
treatment
use
rates
represents
a
very
small
proportion
of
the
naturally
occurring
bacilli
in
the
soil
and
therefore
is
not
expected
to
add
substantially
to
the
effects
of
the
naturally
occurring
Bacillus.
VI.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
the
Agency
to
considered
the
cumulative
effect
of
exposure
to
B.
pumilus
GB
34
and
to
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
include
the
possible
cumulative
effects
of
such
residues
on
infants
and
children.
B.
pumilus
does
not
appear
to
be
toxic
or
pathogenic
to
humans.
Thus,
there
is
no
indication
that
the
bacteria
we
consider
here
share
any
common
mechanisms
of
toxicity
(
metabolic
mechanisms)
with
other
substances.

VII.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
There
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposures
to
residues
of
B.
pumilus
GB
34,
in
its
use
as
a
seed
treatment,
to
the
U.
S.
population,
including
infants
and
children.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
As
discussed
previously,
there
is
probably
no
potential
for
harm,
from
this
bacterium
in
its
use
as
a
seed
treatment
via
dietary
exposure
since
the
organism
is
non­
toxic
and
nonpathogenic
to
animals
and
humans.
The
Agency
has
arrived
at
this
conclusion
based
on
the
very
low
levels
of
mammalian
toxicity
(
no
toxicity
at
the
maximum
doses
tested,
Toxicity
Categories
III
and
IV).
Moreover
no
inhalation
or
dermal
exposure
is
expected.
FFDCA
section
408(
b)(
2)(
C)
provides
that
EPA
shall
apply
an
additional
ten­
fold
margin
of
exposure
(
safety)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
often
referred
to
as
uncertainty
(
safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
the
bacterium,
B.
pumilus
GB34,
is
nontoxic
to
mammals,
including
infants
and
children.
Because
there
are
no
threshold
effects
of
concern,
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
As
a
result,
EPA
has
not
used
a
margin
of
exposure
(
safety)
approach
to
assess
the
safety
of
B.
pumilus
GB
34.

VIII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
FFDCA
section
408(
p)
to
develop
a
screening
process
to
determine
whether
pesticide
chemicals
(
and
any
other
substance
that
may
have
an
effect
that
is
cummulative
to
an
effect
of
a
pesticide
chemical)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effects
effect
as
the
Administrator
may
designate.''
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen­
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruptor
Screening
Program
have
been
determined,
B.
pumilus
GB
34
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
any
effects
related
to
endocrine
disruption.
Based
on
the
weight
of
the
evidence
of
available
data,
no
endocrine
systemrelated
effects
have
been
identified
for
B.
pumilus
GB
34.

B.
Analytical
Method(
s)
The
Agency
proposes
to
establish
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.
Accordingly,
the
Agency
has
concluded
that
analytical
methods
are
not
needed
for
enforcement
purposes
related
to
B.
pumilus
GB
34.

C.
Codex
Maximum
Residue
Level
There
are
no
Codex
Maximum
Residue
Levels
nor
any
tolerances
or
exemptions
issued
for
B.
pumilus
GB
34
outside
the
United
States.

IX.
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
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and
Regulations
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)
of
the
FFDCA,
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
 
2002
 
0328
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
June
2,
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
judgment
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
FFDCA
section
408(
m).''
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
IX.
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
 
2002
 
0328,
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).

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
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/
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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.
Congressonial
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:
March
12,
2003.
James
Jones,
Acting
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
180.1224
is
added
to
subpart
D
to
read
as
follows:

§
180.1224
Bacillus
pumilus
GB
34;
exemption
from
the
requirement
of
a
tolerance.
An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
the
microbial
pesticide
Bacillus
pumilus
GB
34
when
used
as
a
seed
treatment
in
or
on
soybeans
and
soybeans
after
harvest.
[
FR
Doc.
03
 
7638
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0079;
FRL
 
7297
 
8]

Modified
Acrylic
Polymers;
Revision
of
Tolerance
Exemption
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
revises
an
existing
exemption
from
the
requirement
of
a
tolerance
for
modified
acrylic
polymers
when
used
as
an
inert
ingredient
in
a
pesticide
chemical
formulation,
including
antimicrobial
pesticide
chemical
formulations
if
such
is
used
in
accordance
with
good
agricultural
or
manufacturing
practices.
Alco
Chemical
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
revisions
to
the
existing
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
modified
acrylic
polymers.

DATES:
This
regulation
is
effective
April
2,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0079,
must
be
received
on
or
before
June
2,
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
XI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Treva
Alston,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8373;
e­
mail
address:
alston.
treva@
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
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
25532)
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
VerDate
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31>
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14:
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01,
2003
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