FILE
NAME:
Polyisobutylene.
wpd
(
06/
15/
2005)

ATTENTION:

All
commodity
terms
must
comply
with
the
Food
and
Feed
Commodity
Vocabulary
database
(
http://
www.
epa.
gov/
pesticides/
foodfeed/).

All
text
in
blue
font
(
instructions
for
preparing
the
document),
should
be
removed
prior
to
sending
the
document
to
the
Federal
Register
Staff.
Instructional
text
and
prompts
in
green
font
should
also
be
removed.

COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2005)

EPA
Registration
Division
contact:
[
Name:
Bipin
Gandhi;
Telephone
Number:
(
703)
308­
8380
]

INSTRUCTIONS:
Please
utilize
this
outline
in
preparing
tolerance
petition
documents.
In
cases
where
the
outline
element
does
not
apply
please
insert
"
NA­
Remove"
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that
appear
in
italics
and
brackets,
i.
e.,
"[
insert
company
name],"
with
the
information
specific
to
your
action.

TEMPLATE:

[
Miller
Chemical
and
Fertilizer
Corporation]

[
Insert
petition
number]

EPA
has
received
a
pesticide
petition
([
insert
petition
number])
from
[
Miller
Chemical
and
Fertilizer
Corporation],
[
P.
O.
Box
333,
120
Radio
Road,
Hanover,
PA
17331]
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.

Option
2
(
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for)

1.
by
establishing
a
tolerance
for
residues
of
2.
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
2
[
polybutylene
as
a
pesticide
inert
ingredient]
in
or
on
the
raw
agricultural
commodities..
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.
Toxicological
Profile
[
As
part
of
the
EPA
policy
statement
on
inert
ingredients
published
in
the
Federal
Register
(
52
FR
13305,
April
22,
1987),
the
Agency
set
forth
a
list
of
studies
which
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.
Miller
Chemical
and
Fertilizer
Corporation
believes
that
the
data
and
the
information
described
below
are
adequate
to
ascertain
the
toxicology
and
characterize
the
risk
associated
with
the
use
of
butene,
homopolymer
(
CAS
Reg.
No.:
9003­
29­
6)
as
an
inert
ingredient
in
pesticide
formulations
applied
to
growing
crops
and
raw
agricultural
commodities
after
harvest.

In
the
case
of
certain
chemical
substances
that
are
defined
as
"
polymers"
the
EPA
has
established
a
set
of
criteria
which
identify
categories
of
polymers
that
present
low
risk.
These
criteria
(
codified
in
40
CFR
723.250)
identify
polymers
that
are
relatively
unreactive
and
stable
compared
to
other
chemical
substances
as
well
as
polymers
thta
rae
not
readily
absorbed.
These
properties
generally
limit
a
polymer's
ability
to
cause
adverse
effects.
In
addition,
these
criteria
exclude
polymers
about
which
little
is
known.
The
EPA
believes
that
polymers
meeting
the
criterai
noted
beloe
will
present
minimal
or
no
risk.

Butene,
homopolymer
(
synonyms:
polybutene,
polyisobutylene,
butene­
isobutylene
copolymer)
conforms
to
the
definition
of
polymer
given
in
40
CFR
723.250(
b)
and
meets
the
following
criteria
that
are
used
to
identify
low
risk
polymers.

1.
Polyisobutylene
is
not
a
cationic
polymer,
nor
is
it
reasonably
anticipated
to
become
a
cationic
polymer
in
a
natural
acquatic
environment.

2.
Polyisobutylene
contains
as
an
integral
part
of
its
composition
the
atomic
elements
carbon
and
hydrogen.

3.
Polyisobutylene
does
not
contain
as
an
integral
part
of
its
composition
any
elements
other
those
listed
in
40
CFR
723.250(
d)(
2)(
ii).

4.
Polyisobutylene
is
not
designed,
nor
is
it
reasonably
anticipated
to
substantially
degrade,
decompose,
or
depolymerize.
3
5.
Polyisobutylene
is
not
manufactured
or
imported
from
monomers
and/
or
other
reactants
that
are
not
already
included
on
the
Toxic
Substances
Control
Act
(
TSCA)
Chemical
Substance
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.

6.
Polyisobutylene
is
not
a
water
absorbing
polymer.

7.
Polyisobutylene
does
not
contain
any
group
as
reactive
functional
groups.

8.
The
minimum
number­
average
molecular
weight
of
polyisobutylene
is
listed
as
1100
daltons.
Substances
with
molecular
weights
grater
than
400
generally
are
not
absorbed
through
the
intact
skin,
and
substances
with
molecular
weights
greater
than
1,000
generally
are
not
absorbed
through
the
intact
gastrointestinal
(
GI)
tract.
Chemicals
not
absorbed
through
the
skin
or
GI
tract
generally
are
incapable
of
of
eliciting
a
toxic
response.

9.
Polyisobutylene
has
a
number­
average
molecular
weight
of
1100
and
contains
less
than
2.5%
oligomeric
material
below
molecular
weight
of
500
and
less
than
24%
oligomeric
material
below
1,000
molecular
weight.

In
addition,
polybutylene
(
synonyms:
polyisobutylene;
butene,
homopolyemr
and
butene­
isobutylene
copolymer)
is
approved
by
the
Food
and
Drug
Administration
(
FDA)
under
21
CFR
for
following
food
contact
applications:

a)
Polybutylene,
also
known
as
isobutylene­
butene
copolymers,
is
cleared
for
use
in
contact
with
food
under
21
CFR
177.1430.
The
specifications
set
forth
in
this
regulation
for
isobutylene­
butene
copolymers
include
molecular
weight
range
(
150­
5000),
viscosity
range
and
maximum
bromine
values.

b)
Polybutylene
is
approved
under
21
CFR
175.125
for
use
as
a
component
of
release
coatings
on
backings
or
linings
for
pressure
sensitive
adhesive
labels
for
food
contact
applications.

c)
Polybutylene
is
approved
under
21
CFR
175.300
for
use
as
a
component
of
resinous
and
polymeric
coatings
for
food
contact
surfaces.

d)
Polybutylene
is
approved
under
21
CFR
176.170
for
use
as
a
component
of
paper
and
paperboard
in
contact
with
aqueous
and
fatty
foods.

e)
Polybutylene
is
approved
under
21
CFR
176.180
for
use
as
a
component
of
paper
and
paperboard
in
contact
with
dry
foods.

f)
Polybutylene
is
approved
under
21
CFR
176.210
for
use
as
a
defoaming
agent
in
the
manufacture
of
paper
and
paperboard
that
come
in
contact
with
food.
4
g)
Polybutylene
is
approved
under
21
CFR
177.1520
for
use
as
a
plasticizer
in
polyethylene
used
in
the
manufacture
of
articles
for
food
contact
applications.

h)
Polybutylene
is
approved
under
21
CFR
177.1640
for
use
as
a
plasticizer
in
polystyrene
used
in
the
manufacture
of
articles
for
food
contact
applications.

i)
Polybutylene
is
approved
under
21
CFR
177.2800
for
use
as
a
component
of
textiles
and
textile
fibers
used
in
the
manufacture
of
articles
for
food
contact
applications.

j)
Polybutylene
is
approved
for
use
in
lubricants
with
incidental
food
contact
under
21
CFR
178.3570.

k)
Polybutylene
is
approved
under
21
CFR
178.3710
for
use
as
a
component
of
articles
that
come
in
contact
with
food.

l)
Polybutylene
is
approved
under
21
CFR
178.3740
for
use
as
a
component
of
articles
that
come
in
contact
with
food.

The
above
regulations
are
applicable
to
polybutylenes
manufactured
from
isobutylene
and
n­
butene
as
monomers
(
complying
with
21
CFR
177.1430).
The
FDA
has
also
approved
polybutylene
for
other
food
contact
applications
under
21
CFR
175.105
,
21
CFR
177.1420,
177.1520,
177.2260,
and
178.3910.
In
other
words,
the
FDA
has
determined
that
polybutylenes
are
safe
to
use
in
articles
that
come
in
contact
with
food.

Polybutylene
is
widely
used
as
a
cosmetic
ingredient
in
personal
care
products.
The
Cosmetic
Toiletry
and
Fragrance
Association
(
CTFA)
evaluated
the
safety
of
polybutene
for
use
in
personal
care
products
and
found
that
it
is
safe
to
use
in
cosmetic
products.

Polybutylene
(
CAS
Reg.
No.:
9003­
29­
6)
and
all
components
of
polybutylene
are
listed
on
the
TSCA
Chemical
Substances
Inventory.

Polybutenes
are
exempt
from
the
requirement
of
a
tolerance
under
40
CFR
180.1037
for
residues
in
or
on
the
raw
agricultural
commodity:

a)
Cottonseed
when
used
as
a
sticker
agent
for
formulations
of
the
attractant
gossyplure
[
1:
1
mixture
of
(
Z,
Z)­
and
(
Z,
E)­
7,11­
hexadecadien­
1­
ol
acetate]
to
disrupt
the
mating
of
the
pink
bollworm.

b)
Artichokes
when
used
as
a
sticker
agent
in
multi­
layered
laminated
controlled­
release
dispensers
of
(
Z)­
11­
hexadecenal
to
disrupt
the
mating
of
the
artichoke
plume
moth.]
5
B.
Aggregate
Exposure:

[
Polybutylene
and
its
formulations
have
been
in
commerce
for
more
than
30
years.
The
copolymer
is
ubiquitous
in
our
every
day
environment
and
it
is
commonly
used
in
cosmetic
formulations
(
concentrations
ranging
from
1
to
>
50%),
adhesives,
caulks,
sealants,
glazing
compounds,
coatings,
lubricants,
stretch
wrap
film
and
electrical
cable
insulation.

Although
exposure
to
polybutylene
may
occur
through
dietary
(
e.
g.,
adhesives,
lubricants
and
food
wrappings)
and
non­
occupational
(
e.
g.,
electrical
cable
insulation)
sources,
the
chemical
characteristics
of
polybutylene
lead
to
the
conclusion
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
this
polymer.

The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
(
as
described
previously
for
polybutylene)
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
products
applied
to
food
crops.
EPA
has
also
established
exemptions
from
tolerance
for
polymeric
materials
used
as
pesticide
inert
ingredients
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
and
are
thereby
not
subject
to
the
requirements
of
the
premanufacturing
notification.

Given
the
existing
widespread
and
historic
use
of
polybutylene,
any
additional
exposure
resulting
from
the
approval
of
polybutylene
as
an
inert
ingredient
in
pesticide
formulations
for
use
on
growing
crops
or
to
raw
agricultural
commodities
after
harvest
is
not
warranted.]

C.
Cumulative
Effects
[
At
this
time
there
is
no
information
to
indicate
that
any
toxic
effects
produced
by
polybutylene
having
a
number
average
molecular
weight
of
1110
would
be
cumulative
with
those
of
any
other
chemical
substance(
s).
Given
the
categorization
of
polybutylene
as
a
"
low
risk
polymer"
(
40
CFR
723.250)
and
its
proposed
use
as
an
inert
ingredient
in
pesticide
formulations,
there
is
no
reasonable
expectation
of
increased
risk
due
to
cumulative
exposure]

D.
Safety
Determination
1.
U.
S.
population.
[
As
a
matter
of
policy,
EPA
has
in
the
past
established
exemptions
from
tolerance
for
polymeric
substances
used
as
pesticide
inert
ingredients
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
and
are
thereby
not
subject
to
the
requirements
of
premanufacture
notice
(
PMN).
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
raw
agricultural
commodities.]
6
2.
Infants
and
children.
[
FFDCA
section
408
provides
that
EPA
shall
supply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
where
pre­
and/
or
postnatal
toxicity
are
found
or
there
is
incompleteness
of
the
database
,
unless
EPA
concludes
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
the
use
of
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.

Due
to
the
low
expected
toxicity
of
polybutylene,
a
safety
factor
analysis
is
not
required
for
assessing
the
risk.
For
the
same
reasons
the
additional
safety
factor
is
unnecessary.]

F.
International
Tolerances
[
Miller
Chemical
and
Fertilizer
Corporation
is
not
aware
of
any
country
requiring
a
tolerance
for
polybutylene
having
a
number
average
molecular
weight
of
1100.
Nor
have
there
been
any
CODEX
Maximum
Residue
Levels
(
MRLs)
established
for
any
food
crops
at
this
time.
]
