Document ID: EPA-HQ-OPP-2006-0588-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-26T04:00Z

FILE
NAME:
company.
wpt
(
1/
1/
2005)
(
xml)
Template
Number
P25
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.

COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2005)

EPA
Registration
Division
contact:
Kathryn
Boyle,
703­
305­
6304
TEMPLATE:

[
Insert
company
name]

[
Insert
petition
number]

EPA
has
received
a
pesticide
petition
([
insert
petition
number])
from
BASF
Corporation,
100
Campus
Drive,
Florham
Park,
NJ
07932,
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
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
when
used
in
a
pesticide.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
BASF
Corporation
is
petitioning
that
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
be
exempt
from
the
requirement
of
a
tolerance
based
upon
the
definition
of
a
low
risk
polymer
under
40
CFR
723.250(
e).
Consequently,
BASF
Corporation
believes
that
the
analytical
method
to
determine
residues,
2
the
residues
present
in
plant
material,
and
the
magnitude
of
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
in
raw
agricultural
commodities,
is
not
relevant.

1.
Plant
metabolism.
NA­
Remove
2.
Analytical
method.
NA­
Remove
3.
Magnitude
of
residues.
NA­
Remove
B.
Toxicological
Profile
1.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
is
a
polymer
as
defined
by
40
CFR
723.250(
2)(
b).
It
is
composed
of
at
least
3
monomer
units
and
1
other
reactant.
2.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
consists
of
a
simple
weight
majority
of
the
polymer
molecules.
The
monomer
sequences
form
uninterrupted
strings
in
the
polymer
and
distribution
of
the
molecular
weight
of
the
polymer
is
due
largely
to
the
number
of
monomer
units
in
the
individual
molecules.
3.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
consists
of
a
number
average
molecular
weight
of
4,000
with
0%
of
its
oligomeric
material
weighing
below
500
daltons
and
0%
of
its
oligomeric
material
weighing
less
than
1,000
daltons.
4.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
will
not
become
cationic
in
an
aquatic
environment.
It
contains
no
moieties
capable
of
obtaining
a
cationic
charge.
5.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
is
composed
of
carbon,
hydrogen,
and
oxygen;
therefore,
it
meets
the
criteria
of
elemental
composition.
Namely
it
must
be
composed
of
at
least
two
of
the
following
elements
(
and
no
other
elements
than
those
listed):
carbon,
hydrogen,
nitrogen,
oxygen,
silicon,
and
sulfur.
6.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
is
not
designed
nor
reasonably
expected
to
degrade,
decompose,
or
depolymerize
under
normal
use
conditions.
7.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
is
composed
of
molecules
that
are
listed
on
the
TSCA
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.
8.
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
does
not
exceed
the
number
average
molecular
weight
of
10,000
and
therefore
is
not
subject
to
the
water
absorption
limitation.
3
1.
Acute
toxicity.
NA­
Remove
2.
Genotoxicty.
NA­
Remove
3.
Reproductive
and
developmental
toxicity.
NA­
Remove
4.
Subchronic
toxicity.
NA­
Remove
5.
Chronic
toxicity.
NA­
Remove
6.
Animal
metabolism.
NA­
Remove
7.
Metabolite
toxicology.
NA­
Remove
8.
Endocrine
disruption.
NA­
Remove
C.
Aggregate
Exposure
1.
Dietary
exposure.
The
physical­
chemical
characteristics
of
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
leads
to
the
conclusion
that
there
is
a
reasonable
certainty
of
no
harm
from
exposure
to
the
polymer
from
food
or
drinking
water
nor
from
an
aggregate
exposure.

i.
Food.
NA­
Remove
ii.
Drinking
water.
NA­
Remove
2.
Non­
dietary
exposure.
The
physical­
chemical
characteristics
of
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
lead
to
the
conclusion
that
there
is
a
reasonable
certainty
of
no
harm
from
exposure
to
the
polymer
from
non­
dietary
means.

D.
Cumulative
Effects
4
At
this
time
there
is
no
information
to
indicate
that
any
toxic
effects
produced
by
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
would
be
cumulative
with
any
other
chemical.
Given
the
compound's
categorization
as
a
low
risk
polymer,
and
its
proposed
use
in
pesticide
formulations,
there
is
no
expectation
of
increased
risk
due
to
cumulative
exposure.

E.
Safety
Determination
1.
U.
S.
population.
Based
on
the
polymer's
physical­
chemical
properties,
and
that
it
meets
or
exceeds
the
polymer
exemption
criteria
at
40
CFR
723.250
for
low­
risk
polymers,
adverse
effects
are
not
expected.

2.
Infants
and
children.
Based
on
the
polymer's
physical­
chemical
properties,
and
that
it
meets
or
exceeds
the
polymer
exemption
criteria
at
40
CFR
723.250
for
low­
risk
polymers,
adverse
effects
are
not
expected.

F.
International
Tolerances
There
are
no
CODEX
maximum
residue
limits
established
for
[
alpha]­
Butyl­[
omega]­
hydroxypoly(
oxypropylene)
block
polymer
with
poly(
oxyethylene)
in
or
on
crops
or
commodities
at
this
time.