Document ID: EPA-HQ-OPP-2006-0550-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-26T04:00Z

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
8380]

TEMPLATE:

[
The
Lubrizol
Corporation]

[
5E6990]

EPA
has
received
a
pesticide
petition
([
5E6990])
from
[
The
Lubrizol
Corporation],
[
29400
Lakeland
Blvd.,
Wickliffe,
Ohio
44092]
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
180.960
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
[
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
(
No
CASRN;
EPA
Accession
No.
251695)]
in
or
on
the
raw
agricultural
commodity
[
seeds].
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
a.
Analytical
chemistry:
Lubrizol
is
petitioning
that
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
(
No
CASRN;
EPA
Accession
No.
251695)
be
exempt
from
the
requirement
of
a
tolerance
based
on
the
definition
of
a
low
risk
polymer
under
40
CFR
723.250(
e).
Therefore,
the
analytical
method
to
determine
residues
of
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
in
raw
agricultural
commodities
is
not
required.
b.
The
polymeric
substance
is
an
acrylic
copolymer
latex,
the
product
of
the
polymerization
of
methacrylic
acid,
ethyl
acrylate
and
PEG
behenyl
ether
methacrylate.
The
polymer
is
supplied
as
an
aqueous
dispersion
of
approximately
30
wt%
latex
solids
in
water
containing
sodium
lauryl
sulfate
(
0.4
wt%)
as
a
surface­
active
agent.
c.
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
will
be
used
in
accordance
with
good
agricultural
practices
and
no
residues
are
expected.]
2
B.
Toxicological
Profile
1.
Acute
toxicity.
[
As
part
of
the
EPA
policy
statement
on
inert
ingredients
published
in
the
Federal
Register
of
April
22,
1987
(
52
FR
13305),
the
Agency
set
forth
a
list
of
studies
that
would
generally
be
used
to
evaluate
the
risks
posed
by
the
presence
of
an
inert
ingredient
in
a
pesticide
formulation.
However,
where
it
can
be
determined
without
the
data
that
the
inert
ingredient
will
present
minimal
or
no
risk,
the
Agency
generally
does
not
require
some
or
all
of
the
listed
studies
to
rule
on
the
proposed
tolerance,
or
exemption
from
the
requirement
of
a
tolerance,
for
an
inert
ingredient.
The
established
set
of
criteria
for
polymers
of
low
concern
is
described
in
40
CFR
723.250
for
polymers
that
are
relatively
unreactive
and
stable
compared
to
other
chemical
substances.
These
properties
generally
limit
the
ability
of
a
polymer
to
cause
adverse
effects.
Lubrizol
believes
that
the
data
and
information
described
below
is
adequate
to
ascertain
the
toxicology
and
characterize
the
risk
associated
with
the
use
of
the
polymer
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
as
an
inert
ingredient
in
pesticide
formulations
applied
to
raw
agricultural
commodities
(
seeds).
a)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
has
been
notified
to
the
TSCA
Inventory
and
is
listed
as
polymer
exempt
(
XU)
(
EPA
PMN
No.
P­
03­
216;
Accession
No.
251695).
b)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
not
cationic.
c)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
contains
as
an
integral
part
of
its
composition
the
atomic
elements
carbon,
oxygen
and
hydrogen.
d)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
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).
e)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
not
designed,
nor
is
it
reasonably
anticipated,
to
substantially
degrade,
decompose
or
depolymerize.
f)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
not
manufactured
or
imported
from
monomers
and/
or
other
reactants
that
are
not
already
on
the
TSCA
chemical
substance
inventory
g)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
a
water
absorbing
polymer.
However,
this
property
was
not
considered
a
concern
by
the
Agency.
1.
The
acrylic
copolymer
is
a
rheology
modifier
for
use
in
aqueous
compositions.
The
polymer
is
manufactured
using
a
water
soluble
initiator
in
the
emulsion
polymerization
reaction
that
yields
an
aqueous
latex
dispersion
at
an
approximate
30
wt%
solids
content.
The
polymer
is
manufactured
and
only
intended
for
commerce
as
an
aqueous
latex
dispersion.
The
manufactured
polymer
can
not
readily
be
rendered,
or
used,
in
the
form
of
a
solid.
Therefore,
water
swelling
is
not
a
concern
for
the
Agency.
3
h)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
does
not
contain
reactive
functional
groups.
i)
The
polymer
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
has
a
number­
average
molecular
weight
of
94,600
Daltons
(
molecular
weight
distribution
8,100
 
6,421,000
Daltons).
Substances
with
molecular
weight
greater
than
400
generally
are
not
absorbed
through
the
intact
skin,
and
substances
with
molecular
weights
greater
than
1000
generally
are
not
absorbed
through
the
intact
gastrointestinal
tract.
Chemicals
not
absorbed
through
the
skin
or
GI
tract
generally
are
incapable
of
eliciting
a
toxic
response.
j)
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
esters
contains
<
0.01
wt%
oligomeric
material
below
molecular
weight
500,
and
<
0.01
wt%
oligomeric
material
below
1000
molecular
weight.
k)
While
not
expected
to
be
elicit
systemic
toxicity,
the
acrylic
copolymer
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
known
to
be
a
mild
dermal
and
ocular
irritant.
Studies
in
rabbits
resulted
in
a
dermal
Primary
Irritant
Index
score
=
0.5
(
mild
irritant)
and
a
maximum
mean
ocular
irritation
score
=
10.0
(
scale
0
 
110;
mild
irritant).
The
irritation
study
reports
are
submitted
as
a
separate
attachment
to
this
submission.
This
polymer
would
not
contribute
significantly
to
the
irritation
potential
of
the
end­
use
formulation.
l)
It
should
be
noted
that
many
similar
acrylic
copolymers
have
been
found
to
be
polymers
of
low
concern
and
ruled
to
be
low
risk
polymers
by
the
Agency.
2.
Sodium
lauryl
sulfate
(
CASRN
151­
21­
3)
is
present
in
the
commercial
mixture
as
a
surface­
active
agent
to
a
concentration
of
0.4
wt%.
The
surfactant
(
sodium
lauryl
sulfate)
does
not
become
an
intrinsic
part
of
the
polymer,
rather
it
is
absorbed
onto
the
surface
of
the
polymer
particles.
a)
Sodium
lauryl
sulfate
(
CASRN
151­
21­
3)
is
listed
as
a
food
additive
permitted
for
direct
addition
to
food
for
human
consumption
(
21
CFR
172.822)
and
as
a
surface­
active
agent
that
may
be
safely
used
in
the
manufacture
of
articles,
or
components
of
articles
intended
for
use
in
producing,
manufacturing,
packing,
processing,
preparing,
treating,
packaging,
transporting
or
holding
food
(
21
CFR
178.3400).
b)
Sodium
lauryl
sulfate
is
listed
under
a
larger
grouping
of
inert
ingredients
(
alkyl
[
C8­
C18]
sulfate
and
its
ammonium,
calcium,
isopropylamine,
magnesium,
potassium,
sodium
and
zinc
salts)
that
are
exempted
from
the
requirement
of
a
tolerance
when
used
in
accordance
with
good
agricultural
practice
in
pesticide
formulations
when
applied
to
growing
crops
or
to
raw
agricultural
commodities
after
harvest
(
40
CFR
180.910).]
4
2.
Endocrine
disruption.
[
The
is
no
evidence
that
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
an
endocrine
disruptor,
individually
or
in
combination
with
any
other
chemical.
Further,
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
not
part
of
a
class
of
chemicals
that
have
been
previously
alleged
to
cause
adverse
endocrine
effects.]

C.
Aggregate
Exposure
1.
Dietary
exposure.
[
Exposure
to
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
expected
to
be
minimal
based
upon
intended
use
as
a
agricultural
seed
coating
rheology
modifier.
In
light
of
the
high
molecular
weight
polymeric
nature
of
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers,
this
material
is
not
expected
to
be
absorbed
through
the
intact
gastrointestinal
tract
and
is
therefore
considered
incapable
of
eliciting
a
toxic
response.
The
chemical
characteristics
of
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
leads
to
the
conclusion
the
there
is
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
the
polymer.]

i.
Food.
[
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
formulations
applied
to
food
crops.
EPA
has
also
established
exemptions
from
tolerance
for
polymeric
materials
used
as
pesticide
inerts
that
it
considers
to
be
intrinsically
safe
based
on
the
fact
that
they
are
listed
on
the
TSCA
Inventory
or
meet
the
requirements
of
the
amended
TSCA
polymer
exemption.
Exposure
to
the
final
use
dilution
of
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
when
used
as
an
inert
ingredient
in
pesticide
formulations
is
believed
to
be
inconsequential.
]

ii.
Drinking
water.
[
Based
on
the
aqueous
insolubility
of
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers,
there
is
no
reason
to
expect
human
exposure
to
residues
in
drinking
water.]

2.
Non­
dietary
exposure.
[
Based
upon
the
intended
use
of
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
as
a
agricultural
seed
coating
rheology
modifier,
the
primary
route
of
exposure
would
be
dermal.
However,
with
a
molecular
weight
of
the
polymer
is
orders­
of­
magnitude
greater
than
400,
indicating
that
this
polymer
is
not
expected
to
be
absorbed
through
intact
skin.]

D.
Cumulative
Effects
[
At
this
time
there
is
no
indication
that
adverse
effects
produced
by
2­
propenoic,
2­
methyl­,
polymers
5
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
would
be
cumulative
with
those
of
any
other
chemical.
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
is
categorized
as
a
low
risk
polymer
(
40
CFR
723.250).
Polymeric
chemicals
with
molecular
weights
greater
than
1000
are
not
absorbed
through
intact
gastrointestinal
tract
or
skin,
and
therefore
are
generally
regarded
as
incapable
of
eliciting
a
toxic
response.
For
the
proposed
use
as
an
inert
ingredient
in
per­
emerge
pesticide
formulations,
there
is
no
reasonable
expectation
of
increased
risk
due
to
cumulative
exposure.]

E.
Safety
Determination
1.
U.
S.
population.
[
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
causes
no
safety
concerns
because
it
conforms
to
the
definition
of
a
low­
risk
polymer
given
in
40
CFR
723.250,
and
as
such
is
considered
incapable
of
eliciting
a
toxic
response.
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
formulations.
Also,
there
are
no
additional
pathways
of
exposure
(
non­
occupational,
drinking
water,
etc.)
where
there
would
be
additional
risk.]

2.
Infants
and
children.
[
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers
causes
no
additional
concerns
to
infants
and
children
because
it
conforms
to
the
definition
of
a
low
risk
polymer
given
in
40
CFR
723.250,
and
as
such
is
considered
incapable
of
eliciting
a
toxic
response.
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
formulations.
Also
there
are
no
additional
pathways
of
exposure.]

F.
International
Tolerances
[
No
international
tolerances
have
been
established
for
2­
propenoic,
2­
methyl­,
polymers
with
ethyl
acrylate
and
polyethylene
glycol
methylacrylate
C18­
22
alkyl
ethers.]