FILE
NAME:
biopetit.
wpt
(
7/
1/
2005)
(
xml)

Number:
P4
EPA
BIOPESTICIDES
AND
POLLUTION
PREVENTION
DIVISION
COMPANY
NOTICE
OF
FILING
TEMPLATE
FOR
PESTICIDE
PETITIONS
PUBLISHED
IN
THE
FEDERAL
REGISTER
(
7/
1/
2005)

EPA
Biopesticides
and
Pollution
Prevention
Division
contact:
Anne
Ball,
703
308
8717
TEMPLATE:

Montana
Microbial
Products
82761­
EUP­
R
EPA
has
received
a
pesticide
petition
82761­
EUP­
R
from
Montana
Microbial
Products,
510
East
Kent
Ave.,
Missoula
MT
59801,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
2.
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
1.
microbial
pesticide
Bacillus
mycoides
isolate
J
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Montana
Microbial
Products
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Montana
Microbial
Products
and
EPA
has
not
fully
evaluated
the
merits
of
the
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.

I.
Montana
Microbial
Products
Petition
Summary
82761­
EUP­
R
A.
Product
name
and
Proposed
Use
Practices
Bacillus
mycoides
isolate
J,
BmJ.
Microbial
Pest
Control
Agent
for
control
of
fungal
and
bacterial
diseases
in
food
crops.
The
proposed
Experimental
Use
Permit
will
evaluate
BmJ
for
diseases
control
in
sugar
beets.
2
B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
B.
Mycoides
isolate
J,
BmJ.
The
"
J"
strain
was
isolated
from
sugar
beets
and
identified
as
B.
mycoides
by
morphology,
and
by
DNA
sequence
analysis.
B.
mycoides
is
a
ubiquitous
soil
organism.
Active
ingredient
in
BmJ
is
spores
and
the
formulation
is
applied
as
a
spray
to
foliage.
Residue
on
foliage
is
spores.

2.
Magnitude
of
residue
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
Studies
of
persistence
of
applied
BmJ
spores
showed
a
rapid
decline
in
spore
recovery
from
treated
sugar
beet
foliage
over
a
two­
week
period.
BmJ
applied
at
106
spores
per
square
centimeter
of
sugar
beet
leaf
surface
declined
to
between
100
and
1000
spores
per
square
centimeter
of
leaf
surface
at
two
weeks
after
application.
These
results
indicate
that
the
level
of
applied
BmJ
spores
will
decline
rapidly
after
completion
of
the
experimental
program.
Given
the
ubiquitous
occurrence
of
B.
mycoides
in
soil
as
described
in
MMP
document
3
(
Garbeva
2003),
the
application
of
BmJ
to
sugar
beet
foliage
would
have
little
effect
on
the
total
level
of
naturally
occurring
B.
mycoides.

Analytical
methods
employed
in
this
study
used
dilution
plating
on
selective
agar
with
B.
mycoides
distinguished
by
its
distinctive
colony
morphology.

3.
A
statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
MMP
would
not
expect
any
residue
of
BmJ
applied
to
sugar
beet
foliage
to
carry
through
sugar
beet
processing
to
create
a
residue
in
refined
sugar
for
human
consumption.
Given
the
rapid
decline
in
recoverable
spores
from
BmJ
treated
foliage,
BmJ
application
will
create
minimal
residues
on
sugar
beet
foliage.
Cattle
fed
sugar
beet
tops
treated
with
BmJ
may
have
an
exposure
to
a
low
level
of
BmJ
spores
or
vegetative
cells.
Given
the
natural
occurrence
of
B.
mycoides,
MMP
does
not
expect
that
exposure
to
applied
BmJ
on
sugar
beet
tops
would
represent
a
significant
increase
in
natural
exposure
of
cattle
to
B.
mycoides.
MMP
would
also
not
expect
any
human
exposure
to
BmJ
spores
in
meat
or
milk
as
a
result
of
feeding
sugar
beet
tops
with
BmJ
residue
to
cattle.

C.
Mammalian
Toxicological
Profile
An
acute
pulmonary
toxicity
pathogenicity
study
showed
no
adverse
effects
from
acute
intratracheal
exposure
to
BmJ
spores.
Inhalation
of
spore
containing
spray
mist
represents
the
most
likely
route
of
human
exposure
to
BmJ
spores
during
the
proposed
experimental
program.
B.
mycoides
is
not
reported
as
a
human
pathogen.
Because
of
the
ubiquitous
level
of
B.
mycoides
in
agricultural
soils,
there
has
been
a
long
term
human
exposure
to
B.
mycoides
in
crops
and
to
any
residual
B.
mycoides
cells
or
spores
in
food
crops.
Comprehensive
searches
of
research
and
3
medical
literature
did
not
identify
any
reference
to
toxicity
or
pathogenicity
of
B.
mycoides
in
humans;
did
not
identify
any
known
metabolites
of
B.
mycoides
fermentation
of
toxicological
significance;
and
did
not
identify
references
to
B.
mycoides
as
producing
toxins
in
food
stuffs
or
implicated
in
food
borne
toxicity.

D.
Aggregate
Exposure
1.
Dietary
exposure.

i.
Food.
MMP
does
not
expect
any
dietary
exposure
to
BmJ
spores
applied
to
sugar
beets.
Spores
applied
to
foliage
would
not
be
expected
to
carry
through
in
processing
into
refined
sugar
and
would
not
be
expected
in
meat
or
milk
from
livestock
fed
on
treated
sugar
beet
tops.

ii.
Drinking
water.
MMP
does
not
foresee
any
dietary
exposure
in
drinking
water
as
a
result
of
applying
to
BmJ
spores
to
sugar
beets
in
the
proposed
experimental
program.
The
proposed
experimental
program
will
not
apply
BmJ
within
½
mile
of
surface
water.

2.
Non­
dietary
exposure.
Non
dietary
exposure
to
BmJ
as
a
result
of
the
proposed
experimental
program
will
be
limited
to
personnel
involved
in
application
and
monitoring
of
the
trial
program.
Personal
protective
equipment
required
for
will
limit
nondietary
exposure.
The
proposed
experimental
program
will
not
apply
BmJ
near
human
habitation,
MMP
will
restrict
public
access
to
test
sites
and
does
not
expect
any
exposure
of
the
general
public
to
BmJ.

E.
Cumulative
Exposure
The
experimental
program
is
for
a
four
month
period
during
one
growing
season
in
one
year.
Cumulative
exposure
will
be
limited.

F.
Safety
Determination
1.
U.
S.
population.
Based
on
the
toxicology
profile,
limited
use
pattern
and
absence
of
food
residues,
BmJ
poses
minimal
safety
risk
to
the
US
population.

2.
Infants
and
children.
Based
on
the
toxicology
profile,
limited
use
pattern
and
absence
of
food
residues,
BmJ
poses
minimal
safety
risk
to
the
US
population.

G.
Effects
on
the
Immune
and
Endocrine
Systems
The
pulmonary
toxicity
pathogenicity
study
conducted
with
BmJ
did
not
show
any
adverse
immune
response
in
treated
animals.
B.
mycoides
is
not
reported
as
a
human
pathogen
and
literature
searches
did
not
identify
any
reports
of
adverse
effects
of
B.
mycoides
on
the
immune
or
endocrine
systems.

H.
Existing
Tolerances
There
are
no
existing
tolerances
established
for
B.
Mycoides
isolate
J.
4
I.
International
Tolerances
There
are
no
existing
international
tolerances
established
for
B.
Mycoides
isolate
J
[
FR
Doc.
05­?????
Filed
??­??­
05;
8:
45
am]
[
BILLING
CODE
6560­
50­
S]
