Document ID: EPA-HQ-OPP-2006-0480-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-07T04:00Z

FILE
NAME:
company.
wpt
(
7/
1/
2005)
(
xml)
Template
Number
P25
COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2005)

EPA
Registration
Division
contact:
Bipin
Gandhi
703­
308­
8811]

TEMPLATE:

[
Cognis
Corporation]

[
6E7067]

EPA
has
received
a
pesticide
petition
([
6E7067])
from
[
Cognis
Corporation],
[
4900
Este
Avenue,
Cincinnati,
OH
45232]
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
[
Soybean
Oil
,
Polyethoxylated;
the
Poly(
oxyethylene)
Content
Averages
10
moles
or
Greater]
in
or
on
[
all]
the
raw
agricultural
commodity]
[
when
used
as
an
inert
ingredient
in
pesticide
formulations
under
40
CFR
§
180.960
(
polymers).]
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
1.
Plant
metabolism.
[
Cognis
Corporation
is
petitioning
EPA
to
Exempt
Soybean
Oil,
Polyethoxylated
(
Trade
Name
Agnique
SBO­
10)
from
the
requirement
of
a
tolerance
since
this
inert
ingredient
qualifies
under
the
polymer
exemption
criteria
(
low­
risk
polymer)
of
40
CFR
§
723.250(
e).
Consequently,
plant
metabolism
data
is
not
necessary.]

2.
Analytical
method.
[
Since
the
petitioner
is
requesting
a
tolerance
exemption
an
analytical
method
for
residues
of
the
polymer
in
food
crops
is
not
required.]

B.
Toxicological
Profile
2
[
Where
it
can
be
determined
that
an
inert
ingredient
meets
the
definition
of
an
exempt
or
low­
risk
polymer
(
40
CFR
§
723.250)
then
the
production
of
data
is
generally
not
required
by
EPA
to
establish
a
tolerance
or
the
exemption
from
a
tolerance.
Cognis
Corporation
asserts
that
the
data
and
information
provided
below
are
sufficient
to
establish
the
potential
activity,
toxicity,
and
risks
associated
with
Agnique
SBO­
10
as
an
inert
ingredient
when
applied
to
growing
crops
or
raw
agricultural
commodities.
Further,
in
the
case
of
chemical
substances
described
as
polymers,
EPA
has
established
criteria,
which
when
they
are
met
or
exceeded,
are
considered
low­
risk.
These
criteria
are
described
in
40
CFR
§
723.250,
and
identify
polymers
that
are
relatively
unreactive,
stable,
and
typically
are
not
absorbed
when
compared
to
other
chemical
substances
including
some
polymers.
The
criteria
described
in
40
CFR
§
723.250,
and
addressed
below,
will
generally
exclude
polymer
chemicals
that
are
not
well­
known
and
understood,
and
potentially
present
a
significant
risk
of
adverse
effects.
Therefore,
the
polymers
that
meet
or
exceed
these
criteria
can
be
considered
minimal
or
negligible
risk.
As
present
below,
Soybean
Oil,
Polyethoxylated
conforms
to
the
definition
of
a
low­
risk
polymer
as
described
in
40
CFR
§
723.250.
a.
Agnique
SBO­
10
is
not
a
cationic
polymer,
nor
is
it
reasonably
anticipated
to
become
a
cationic
polymer
in
a
natural
aquatic
environment.
b.
Agnique
SBO­
10
contains
as
the
integral
part
of
its
composition
the
atomic
elements
hydrogen,
carbon,
and
oxygen.
c.
Agnique
SBO­
10
does
not
contain
as
an
integral
part
of
its
composition,
except
as
impurities,
any
elements
other
than
those
listed
in
40
CFR
723.250(
d)(
2)(
ii).
d.
Agnique
SBO­
10
is
not
designed
nor
reasonably
anticipated
to
substantially
depolymerize,
degrade,
or
decompose.
e.
Agnique
SBO­
10
is
manufactured
from
monomers
that
are
listed
in
the
Toxic
Substances
Control
Act
(
TSCA)
Chemical
Substance
Inventory
or
manufactured
under
an
applicable
TSCA
Section
5
exemption.
f.
Agnique
SBO­
10
is
not
a
water
absorbing
polymer.
g.
Agnique
SBO­
10
does
not
contain
any
reactive
functional
groups.
h.
The
number­
average
molecular
weight
of
Agnique
SBO­
10
is
approximately
1,900
daltons.
Substances
with
molecular
weights
greater
than
400
daltons
are
generally
not
absorbed
through
the
intact
skin,
and
substances
with
molecular
weights
greater
than
1,000
daltons
are
generally
not
absorbed
through
the
intact
gastrointestinal
(
GI)
tract.
Chemicals
not
absorbed
through
the
skin
or
GU
tract
are
incapable
of
eliciting
a
toxic
response
via
these
routes
of
exposures.
i.
Agnique
SBO­
10
contains
less
than
2%
oligomeric
material
below
molecular
weight
of
500
daltons
and
25%
oligomeric
material
below
1,000
daltons.]
3
1.
Dietary
exposure.
[
Since
Agnique
SBO­
10
is
considered
a
low­
risk
polymer
there
is
a
reasonable
certainty
of
no
harm
from
exposure
to
this
polymer
from
food
or
drinking
water
or
from
aggregate
exposure.]

2.
Non­
dietary
exposure.
[
Since
Agnique
SBO­
10
is
considered
a
low­
risk
polymer
there
is
a
reasonable
certainty
of
no
harm
from
exposure
to
this
polymer
from
non­
dietary
means.]

D.
Cumulative
Effects
[
At
this
time,
there
is
no
information
to
indicate
that
any
toxic
effects
produced
by
Agnique
SBO­
10
are
cumulative
with
those
of
any
other
chemical.
Given
the
compound's
categorization
as
a
low­
risk
polymer,
and
its
proposed
use
in
pesticide
formulation,
there
is
no
expectation
of
increased
risk
due
to
cumulative
exposure.]

E.
Safety
Determination
1.
U.
S.
population.
[
Since
Agnique
SBO­
10
is
considered
a
low­
risk
polymer,
no
adverse
effects
are
expected.]

2.
Infants
and
children.
[
Since
Agnique
SBO­
10
is
considered
a
low­
risk
polymer,
no
adverse
effects
are
expected.]

F.
International
Tolerances
[
There
are
no
CODEX
maximum
residue
levels
(
MRLs)
established
for
residues
of
Agnique
SBO­
10
in
or
on
crops
or
commodities
at
this
time.]