Document ID: EPA-HQ-OPP-2006-0556-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-26T04:00Z

FILE
NAME:
company.
wpt
(
1/
1/
2006)
(
xml)
Template
Number
P25
COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2006)

EPA
Registration
Division
contact:
Bipin
Gandhi,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460­
0001;
telephone
number:
(
703)
308­
8380
TEMPLATE:

[
E.
I.
du
Pont
de
Nemours
&
Company,
Inc.,
1007
Market
Street,
Wilmington,
DE
19898]

[
PP
XXXXXX]

EPA
has
received
a
pesticide
petition
([
PP
XXXXXX])
from
[
E.
I.
du
Pont
de
Nemours
&
Company,
Inc.],
[
1007
Market
Street,
Wilmington,
DE
19898]
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
[
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt]
in
or
on
the
raw
agricultural
commodity
[
NA­
Remove]
at
[
NA­
Remove]
parts
per
million
(
ppm).
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.
[
NA­
Remove]

2.
Analytical
method.
[
NA­
Remove]

3.
Magnitude
of
residues.
[
2
E.
I.
du
Pont
de
Nemours
&
Company,
Inc.
is
petitioning
that
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
be
exempt
from
the
requirement
of
a
tolerance
based
upon
the
definition
of
a
low
risk
polymer
under
40
CFR
723.250(
e).
Consequently,
E.
I.
du
Pont
de
Nemours
&
Company,
Inc.
believes
that
the
analytical
method
to
determine
residues,
the
residues
present
in
plant
material,
and
the
magnitude
of
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
in
raw
agricultural
commodities,
is
not
relevant]

B.
Toxicological
Profile
1.
Acute
toxicity.
[
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
is
a
polymer
as
defined
40
CFR
723.250(
2)(
b).
It
is
composed
of
at
least
3
monomer
units
and
1
other
reactant.
The
neutralized
polymer
is
described
by
CAS
No.
146753­
99­
3.
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
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.
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
consists
of
a
number
average
molecular
weight
of
23,745
to
34,847
daltons
with
0%
of
its
oligomeric
material
weighing
below
500
daltons
and
0%
of
its
oligomeric
material
weighing
less
than
1,000
daltons.
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
will
not
become
cationic
in
an
aquatic
environment.
It
contains
no
moieties
capable
of
obtaining
a
cationic
charge.
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
is
composed
of
carbon,
hydrogen,
nitrogen
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.
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
is
not
designed
nor
reasonably
expected
to
degrade,
decompose,
or
depolymerize
under
normal
use
conditions.
3
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
is
composed
of
molecules
that
are
listed
on
the
TSCA
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.
The
molecular
weight
of
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­
(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
does
exceed
the
number
average
molecular
weight
of
10,000
and
therefore
is
subject
to
the
water
absorption
limitation,
however,
it
is
a
non­
water
absorbing
species.
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
is
an
acrylic
polymer
that
is
partially
described
by
the
existing
acrylic
polymer
descriptions
currently
listed
in
40
CFR
180.960,
with
the
exception
the
monomer,
N­(
hydroxymethyl)­
2­
methylacrylamide
(
CAS#
923­
02­
4),
has
not
been
previously
listed
as
a
monomer
in
this
class
of
polymers.
Hence,
the
only
difference
in
this
polymer
and
those
acrylic
polymers
currently
exempt
from
the
requirement
of
a
tolerance
is
the
presence
of
the
novel
monomer
in
this
polymer.]

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.
[
4
The
physical­
chemical
characteristics
of
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
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
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
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
[
At
this
time
there
is
no
information
to
indicate
that
any
toxic
effects
produced
by
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
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
Poly(
2­
Ethylhexyl
Acrylate/
2­
Hydroxyethyl
Acrylate/
N­(
Hydroxymethyl)­
2­
Methylacrylamide/
Methacrylic
5
Acid/
Methyl
Methacrylate/
Styrene),
Ammonium
Salt
in
or
on
crops
or
commodities
at
this
time.]