Document ID: EPA-HQ-OPP-2006-0603-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-26T04:00Z

COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2006)

EPA
Registration
Division
contact:
[
Dr.
Bipin
Gandhi
(
703)
308­
8380]

]

TEMPLATE:

[
MonoSol,
LLC]

[
Insert
petition
number]

EPA
has
received
a
pesticide
petition
([
insert
petition
number])
from
[
MonoSol,
LLC],
[
1701
County
Line
Road,
Portage,
IN
46368
]
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
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts]
in
or
on
the
raw
agricultural
commodity
[
all
food
commodities]
at
[
without
numerical
limitations]
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
FDDCA;
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
MonoSol,
LLC
is
petitioning
that
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
be
exempt
from
the
requirement
of
a
tolerance
based
upon
the
definition
of
a
low
risk
polymer
under
40
CFR
723.250(
e).
Consequently,
MonoSol,
LLC
believes
that
the
analytical
method
to
determine
residues,
the
residues
present
in
plant
material,
and
the
magnitude
of
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
in
raw
agricultural
commodities,
is
not
relevant.

1.
Plant
metabolism.

2.
Analytical
method.
[
NA
 
Please
Remove]

3.
Magnitude
of
residues.
[
NA
 
Please
Remove]

B.
Toxicological
Profile
1.
Acute
toxicity.
[
POLYMER
EXEMPTION
LANGUAGE
­
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
is
composed
of
at
least
3
monomer
units
and
1
other
reactant.

­
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
consists
of
a
simple
weight
majority
of
the
polymer
molecules.
The
monomer
distribution
in
the
polymer
is
completely
random
and
the
distribution
of
the
molecular
weight
of
the
polymer
is
due
largely
to
the
number
of
monomer
units
in
the
individual
molecules.

­
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
will
not
become
cationic
in
an
aquatic
environment,
and
it
contains
no
moieties
capable
of
obtaining
a
cationic
charge.

­
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
is
composed
of
carbon,
hydrogen
and
oxygen,
and
therefore
meets
the
criteria
of
elemental
composition.
Sodium
exists
as
a
monatomic
counterion.

­
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
will
not
degrade,
decompose
or
depolymerize.

­
All
materials
used
to
prepare
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
are
on
the
TSCA
Chemical
Substance
Inventory
or
are
manufactured
under
an
applicable
TSCA
section
5
exemption.

­
Although
the
number
average
molecular
weight
of
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
exceeds
10,000
and
is
hydrophilic,
it
does
not
fit
the
definition
of
a
water­
absorbing
polymer
in
that
it
does
not
absorb
its
weight
of
water.

­
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
consists
of
a
number
average
molecular
weight
of
36,272
with
zero
percent
of
its
oligomeric
material
weighing
below
500
daltons
and
zero
percent
of
its
oligomeric
material
weighing
less
than
1,000
daltons.]

2.
Genotoxicty.
[
NA
 
Please
Remove.]

3.
Reproductive
and
developmental
toxicity.
[
NA
 
Please
Remove.]

4.
Subchronic
toxicity.
[
NA
 
Please
Remove.]

5.
Chronic
toxicity.
[
NA
 
Please
Remove.]

6.
Animal
metabolism.
[
NA
 
Please
Remove.]

7.
Metabolite
toxicology.
[
NA
 
Please
Remove.]
8.
Endocrine
disruption.
[
NA
 
Please
Remove.]

C.
Aggregate
Exposure
1.
Dietary
exposure.
[
The
physical
and
chemical
characteristics
of
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
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
 
Please
Remove.]

ii.
Drinking
Food.
[
NA
 
Please
Remove.]

2.
Non­
dietary
exposure.
[
The
physical
and
chemical
characteristics
of
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
leads
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
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salts
would
be
cumulative
with
any
other
chemical.
Given
the
compound's
categorization
as
a
low
risk
polymer,
and
its
proposed
use
in
pesticide
and
anti­
microbial
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
and
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
and
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
2­
Propenoic
acid,
methyl
ester,
polymer
with
ethenyl
acetate,
hydrolyzed,
sodium
salt
in
or
on
crops
or
commodities
at
this
time.]