Document ID: EPA-HQ-OPP-2006-0313-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-07T04:00Z

FILE
NAME:
biopetit.
wpt
(
1/
1/
2006)
(
xml)

Number:
P4
ATTENTION:

All
commodity
terms
must
comply
with
the
Food
and
Feed
Commodity
Vocabulary
database
(
http://
www.
epa.
gov/
pesticides/
foodfeed/).

All
text
in
blue
font
(
instructions
for
preparing
the
document),
should
be
removed
prior
to
sending
the
document
to
the
Federal
Register
Staff.
Instructional
text
and
prompts
in
green
font
should
also
be
removed.

EPA
BIOPESTICIDES
AND
POLLUTION
PREVENTION
DIVISION
COMPANY
NOTICE
OF
FILING
TEMPLATE
FOR
PESTICIDE
PETITIONS
PUBLISHED
IN
THE
FEDERAL
REGISTER
(
1/
1/
2006)

EPA
Biopesticides
and
Pollution
Prevention
Division
contact:
[
Rebecca
Edelstein
703
605­
0513]

INSTRUCTIONS:
Use
this
template
in
preparing
your
notice
of
filing
for
your
company's
pesticide
petition.
In
cases
where
the
outline
element
does
not
apply,
insert
"
NA­
Remove"
and
maintain
the
outline.
The
comment
balloons
appearing
in
the
left
margin
contain
Government
Printing
Office
(
GPO)
typesetting
codes
which
expedite
the
Federal
Register
(
FR)
publication
process
at
EPA
for
the
FR
document
containing
your
company's
pesticide
petition.
In
the
template,
do
not
remove
or
alter
the
comment
balloons;
change
the
margins,
font,
or
format;
or
use
the
WordPerfect
comment
function.
Follow
the
instructions
that
appear
italicized,
color
coded,
and
bracketed.

SUBMISSION:
E­
mail
the
completed
template
to:
hollis.
linda@
epa.
gov.

TEMPLATE:

[
BioProdex]

[
Insert
petition
number]

EPA
has
received
a
pesticide
petition
[
insert
petition
number]
from
[
Interregional
Research
Project
Number
4
(
IR­
4),
Rutgers
University]
,
[
Technology
Center
of
New
Jersey,
681
US
Highway
1,
South,
North
Brunswick,
New
Jersey
08902­
3390
on
behalf
of
BioProdex,
Inc.,
Gainesville
Technology
Enterprise
Center
(
GTEC)
,
Box
5,
Suite
205,
2153
2
SE
Hawthorne
Road,
Gainesville,
FL
32641
],
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
Options
(
pick
one)

1.
by
establishing
a
tolerance
for
residues
of
the
2.
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
3.
to
establish
an
amendment/
expansion
of
an
existing
tolerance
exemption
for
the
Options
(
pick
one)

1.
microbial
pesticide
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
,
ATCC
number
PV­
1200]

2.
biochemical
pesticide
[
insert
name
of
active
ingredient]

3.
plant­
pesticide
[
insert
name
of
active
ingredient]
in
or
on
[
insert
commodity].

Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
[
Interregional
Research
Project
Number
4
(
IR­
4),
Rutgers
University]
,
[
Technology
Center
of
New
Jersey,
681
US
Highway
1,
South,
North
Brunswick,
New
Jersey
08902­
3390
on
behalf
of
BioProdex,
Inc.,
Gainesville
Technology
Enterprise
Center
(
GTEC)
,
Box
5,
Suite
205,
2153
SE
Hawthorne
Road,
Gainesville,
FL
32641]
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
[
Interregional
Research
Project
Number
4
(
IR­
4),
Rutgers
University]
,
[
Technology
Center
of
New
Jersey,
681
US
Highway
1,
South,
North
Brunswick,
New
Jersey
08902­
3390
on
behalf
of
BioProdex,
Inc.,
Gainesville
Technology
Enterprise
Center
(
GTEC)
,
Box
5,
Suite
205,
2153
SE
Hawthorne
Road,
Gainesville,
FL
32641]
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.
[
Interregional
Research
Project
Number
4
(
IR­
4),
Rutgers
University]
,
[
Technology
Center
of
New
Jersey,
681
US
Highway
1,
South,
North
Brunswick,
New
Jersey
08902­
3390
on
behalf
of
BioProdex,
Inc.,
Gainesville
Technology
Enterprise
Center
(
GTEC)
,
Box
5,
Suite
205,
2153
SE
Hawthorne
Road,
Gainesville,
FL
32641
]
Petition
Summary
[
Insert
petition
number]

A.
Product
name
and
Proposed
Use
Practices
3
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
,
ATCC
number
PV­
1200
is
the
active
ingredient
in
the
end
use
product
Solvinix.
Solvinix
is
a
postemergence
bioherbicide
for
the
control
of
the
weed
Tropical
Soda
Apple
(
Solanum
viarum).
Ten
grams
of
the
end
use
product
are
diluted
with
10
gallons
of
water
and
applied
with
a
wiper
applicator
at
1
gallon
per
acre
or
spot
sprayed
with
2
gallons
of
water
per
acre.
This
Experimental
Use
Permit
is
for
10,000
acres
in
the
state
of
Florida.
These
include
the
Florida
counties
Alachua,
Bradford,
Brevard,
Calhoun,
Charlotte,
Collier,
Columbia,
Glades,
Hardee,
Hendry,
Hernando,
Highlands,
Hillsborough,
Holmes,
Indian
River,
Jackson,
Manatee,
Marion,
Okeechobee,
Orange,
Osceola,
Polk,
Seminole,
Sumter,
Walton,
Gadsden,
Putnam,
Clay,
Baker,
Hamilton,
Madison,
Washington,
Liberty,
Leon,
Wakulla,
Taylor,
Jefferson,
Suwannee,
Lafayette,
Dixie,
Levy,
Gilchrist,
Lake,
Citrus,
Pasco,
St.
Lucie,
Desoto,
Dade
and
Monroe
for
a
total
of
10,000
acres.
The
total
amount
of
Solvinix
under
this
Experimental
Use
Permit
would
be
50
pounds
of
formulated
material
or
10
pounds
of
active
ingredient.
]

B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
,
ATCC
number
PV­
1200
is
the
active
ingredient
in
the
end
use
product
Solvinix.]

2.
Magnitude
of
residue
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
The
intended
use
of
the
product
is
on
the
weed
Tropical
Soda
Apple.
It
is
not
intended
for
direct
application
on
food
crops.
Tobacco
Mild
Green
Mosaic
Tobamovirus
normally
occurs
in
many
fruiting
vegetables,
cucurbits,
tobacco
and
many
other
crops.
Label
directions
specifically
state
not
to
apply
the
product
within
300
feet
of
eggplant,
pepper,
tomatillo
and
tobacco
crops
therefore
the
use
of
this
product
is
not
expected
to
impact
the
residues
of
Tobacco
Mild
Green
Mosaic
Tobamovirus
on
these
or
other
crops.]

3.
A
statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
An
exemption
from
the
requirement
of
a
tolerance
is
being
requested.
Tobacco
Mild
Green
Mosaic
Tobamovirus
normally
occurs
in
many
fruiting
vegetables,
cucurbits,
tobacco
and
many
other
crops.
Since
it
may
already
be
present
in
crops
it
is
indistinguishable
from
that
which
is
normally
present.
In
addition
since
an
exemption
from
tolerance
is
being
requested
there
is
no
need
to
analyze
for
residues.]

C.
Mammalian
Toxicological
Profile
4
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
It
is
a
plant
Tobamovirus
that
does
not
infect
nor
is
toxic
or
pathogenic
to
insects,
invertebrates,
vertebrates,
mammals
or
humans.
This
is
due
to
the
fact
that
the
cell
surface
plays
an
important
role
in
the
early
stages
of
infection
of
eukaryote,
especially
animal
cells.
Animal
viruses
interact
specifically
with
surface
components
and
plant
viruses
such
as
Tobacco
Mild
Green
Mosaic
Tobamovirus
lack
the
cell
surface
receptors
and
can
only
enter
plants
through
plant
wounds.]

D.
Aggregate
Exposure
1.
Dietary
exposure.

i.
Food.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
The
intended
use
of
the
product
is
on
the
weed
Tropical
Soda
Apple.
It
is
not
intended
for
direct
application
on
food
crops.
Tobacco
Mild
Green
Mosaic
Tobamovirus
normally
occurs
in
many
fruiting
vegetables,
cucurbits,
tobacco
and
many
other
crops
therefore
man
and
animals
are
routinely
exposed
to
Tobacco
Mild
Green
Mosaic
Tobamovirus]

ii.
Drinking
water.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
The
intended
use
of
the
product
is
on
the
weed
Tropical
Soda
Apple.
It
is
not
intended
for
direct
application
in
aquatic
sites
and
tropical
soda
apple
does
not
grow
in
flooded
areas]

2.
Non­
dietary
exposure.
[
The
potential
for
non­
occupational
,
non­
dietary
exposure
to
the
general
population
is
not
expected
to
be
significant.
The
product
use
rate
is
2
grams
per
acre
or
less
and
is
not
expected
to
present
any
risk
of
adverse
health
effects.]

E.
Cumulative
Exposure
[
There
are
no
other
registered
products
containing
Tobacco
Mild
Green
Mosaic
Tobamovirus
the
Tobamovirus
and
does
not
produce
any
toxins.
There
are
no
expected
cummulative
effects
with
other
pesticides.]

F.
Safety
Determination
1.
U.
S.
population.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
The
intended
use
of
the
product
is
on
the
weed
Tropical
Soda
Apple.
It
is
not
intended
for
direct
application
on
food
crops.
Tobacco
Mild
Green
Mosaic
Tobamovirus
normally
occurs
in
many
fruiting
vegetables,
cucurbits,
tobacco
and
many
other
crops.
Label
directions
specifically
state
not
to
apply
the
product
within
300
feet
of
eggplant,
pepper,
tomatillo
and
tobacco
crops
therefore
the
use
of
this
product
is
not
expected
to
impact
the
residues
of
Tobacco
Mild
Green
Mosaic
5
Tobamovirus
on
these
or
other
crops.
It
is
a
plant
Tobamovirus
that
does
not
infect
nor
is
toxic
or
pathogenic
to
insects,
invertebrates,
vertebrates,
mammals
or
humans.]

2.
Infants
and
children.
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
is
a
naturally
occurring
Tobamovirus
which
is
found
worldwide.
The
intended
use
of
the
product
is
on
the
weed
Tropical
Soda
Apple.
It
is
not
intended
for
direct
application
on
food
crops.
Tobacco
Mild
Green
Mosaic
Tobamovirus
normally
occurs
in
many
fruiting
vegetables,
cucurbits,
tobacco
and
many
other
crops.
Label
directions
specifically
state
not
to
apply
the
product
within
300
feet
of
eggplant,
pepper,
tomatillo
and
tobacco
crops
therefore
the
use
of
this
product
is
not
expected
to
impact
the
residues
of
Tobacco
Mild
Green
Mosaic
Tobamovirus
on
these
or
other
crops.
It
is
a
plant
Tobamovirus
that
does
not
infect
nor
is
toxic
or
pathogenic
to
insects,
invertebrates,
vertebrates,
mammals
or
humans.]

G.
Effects
on
the
Immune
and
Endocrine
Systems
[
Tobacco
Mild
Green
Mosaic
Tobamovirus
normally
occurs
in
many
fruiting
vegetables,
cucurbits,
tobacco
and
many
other
crops,
therefore
man
is
routinely
exposed
to
this
plant
Tobamovirus.
There
is
no
known
evidence
that
Tobacco
Mild
Green
Mosaic
Tobamovirus
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disruptor.]

H.
Existing
Tolerances
[
There
are
no
known
existing
tolerances
or
tolerance
exemptions
for
Tobacco
Mild
Green
Mosaic
Tobamovirus.
Since
it
may
already
be
present
in
crops
it
is
indistinguishable
from
that
which
is
normally
present.
An
exemption
from
the
requirement
of
a
tolerance
is
being
requested
.

I.
International
Tolerances
[
There
are
no
known
existing
CODEX
maximum
residue
levels
or
tolerance
exemptions
for
Tobacco
Mild
Green
Mosaic
Tobamovirus.]

[
FR
Doc.
06­?????
Filed
??­??­
06;
8:
45
am]
[
BILLING
CODE
6560­
50­
S]