1
FILE
NAME:
BASF
Corporation
(
1//
1/
2006)
(
xml)
Template
Number
P25
COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2006)

EPA
Registration
Division
contact:
Bipin
Gandhi,
703­
308­
8380
TEMPLATE:

BASF
Corporation
requests
that
the
material
composition
contained
in
the
documents
filed
with
the
USEPA
be
maintained
as
Confidential
Business
Information.

[
6E7063]

EPA
has
received
a
pesticide
petition
([
6E7063])
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
180.960
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
acetic
acid
ethenyl
ester,
polymer
with
1­
ethenyl­
2­
pyrrolidinone
or
vinylpyrrolidone/
vinyl
acetate
copolymer
(
CASRN
(
25086­
89­
9),
here
after
referred
as
vinylpyrrolidone/
vinyl
acetate
copolymer,
in
a
pesticide
in
parts
per
million.
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.
BASF
Corporation
is
petitioning
that
vinylpyrrolidone/
vinyl
acetate
copolymer
be
exempt
from
the
requirement
of
a
tolerance
based
upon
the
definition
of
a
low
risk
polymer
under
40
CFR
723.250(
e).

B.
Toxicological
Profile
1.
Vinylpyrrolidone/
vinyl
acetate
copolymer
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.
This
compound
is
on
the
USEPA
TSCA
Inventory
and
it
is
used
in
cosmetic
formulations.

2.
Vinylpyrrolidone/
vinyl
acetate
copolymer
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.
2
3.
Vinylpyrrolidone/
vinyl
acetate
copolymer
consists
of
a
number
average
molecular
weight
greater
than
10,000
daltons,
with
less
than
1.1%
of
its
oligomeric
material
weighing
below
500
daltons
and
less
than
1.1%
of
its
oligomeric
material
weighing
less
than
1,000
daltons.

4.
Vinylpyrrolidone/
vinyl
acetate
copolymer
will
not
become
cationic
in
an
aquatic
environment.
It
contains
no
moieties
capable
of
obtaining
a
cationic
charge.

5.
Vinylpyrrolidone/
vinyl
acetate
copolymer
is
composed
of
carbon,
hydrogen,
nitrogen
and
oxygen;
and
no
other
elements
therefore,
it
meets
the
criteria
of
elemental
composition.

6.
Vinylpyrrolidone/
vinyl
acetate
copolymer
is
not
designed
nor
reasonably
expected
to
degrade,
decompose,
or
depolymerize
under
normal
use
conditions.

7.
Vinylpyrrolidone/
vinyl
acetate
copolymer
is
composed
of
molecules
that
are
listed
on
the
TSCA
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.

8.
Vinylpyrrolidone/
vinyl
acetate
copolymer
is
not
a
water­
absorbing
polymer,
i.
e.,
it
does
not
absorb
its
weight
in
water.
It
is
a
water
soluble
compound.

C.
Aggregate
Exposure
1.
Dietary
exposure.
The
physical­
chemical
characteristics
of
Vinylpyrrolidone/
vinyl
acetate
copolymer
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.

2.
Non­
dietary
exposure.
The
physical­
chemical
characteristics
of
Vinylpyrrolidone/
vinyl
acetate
copolymer
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
Vinylpyrrolidone/
vinyl
acetate
copolymer
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.
3
2.
Infants
and
children.
Based
on
the
polymer's
physical­
chemical
properties,
and
that
is
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
Vinylpyrrolidone/
vinyl
acetate
copolymer
in
or
on
crops
or
commodities
at
this
time.
