Document ID: EPA-HQ-OPPT-2003-0012-0119
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-06-18T04:00Z

The
Society
of
the
Plastics
Industry,
Inc.
Fluoropolymer
Manufacturers
Group
Response
to
EPA
Preliminary
Framework
for
ECAs
on
PFOA
June
6,
2003
On
behalf
of
SPI's
Fluoropolymer
Manufacturers
Group,
I
would
like
to
make
a
few
brief
comments
regarding
the
s
preliminary
framework
for
ECAs
involving
PFOA.

After
receiving
this
information
over
a
week
ago,
the
FMG
assembled
a
team
oftechnical
professionals
from
their
member
companies
to
evaluate
and
comment
on
the
information
and
concepts
that
were
presented
by
the
EPA.
The
detailed
results
of
that
effort
have
been
submitted
to
the
EPA
in
written
form.

For
purposes
of
this
meeting,
I
would
like
to
summarize
our
findings
and
commitment:

°
First:
I
think
it
is
important
to
say
that
we
believe
we
understand
the
content,
specifics
and
reasoning
behind
the
11
items
that
were
requested
ofthe
fluoropolymer
industry.
°
Second:
The
FMG
supports
the
need
for
data
in
each
ofthe
broad
categories
in
the
framework
document.
°
Third:
There
are
no
issues
raised
in
the
framework
that
the
FMG
categorically
rejects.
°
Fourth:
The
FMG
is
encouraged
by
its
belief
that
much
of
what
is
being
requested
is
either
already
available
within
the
tremendous
amounts
of
existing
information
developed
around
PFOA,
or
will
be
provided
as
a
result
of
the
commitments
made
in
the
LOT
signed
by
the
FMG.
°
Fifth:
The
FMG
believes
that
the
key
to
meeting
the
data
needs
of
all
interested
parties
is
identical
to
the
process
used
earlier
this
year
to
develop
its
LOl
 
specifically,
close
cooperation
between
the
senior
technical
professionals
in
the
EPA
and
the
fluoropolymer
industry,
as
well
as
other
stakeholder
groups.

In
summary,
the
FMG
supports
the
ECA
process
for
completing
the
development
and
analysis
of
critical
data
needed
to
assess
the
regulatory
implications
for
PFOA.
The
FMG
is
committed
to
cooperating
with
the
EPA
and
other
stakeholders
in
creating
ECAs
to
help
understand
the
routes
of
exposure
to
PFOA.

Thank
you
for
the
opportunity
to
share
these
comments.
FLUOROPOLYMER
MANUFACTURERS
GROUP
RESPONSE
TO
EPA
PRELIMINARYFRAMEWORK
FOR
JUNE
6,
2003
MEETING
°
Introduction
In
preparation
for
the
June
6,
2003
public
meeting
for
developing
enforceable
consent
agreements
(
ECAs)
on
perfluorooctanoic
acid
(
PFOA)
and
fluorinated
telomers,
EPA
issued
a
document
dated
May20,
2003
and
entitled
Preliminary
Framework
for
Enforceable
Consent
Agreement
Data
Development
for
PFOA
and
Telomers
(
referred
to
below
as
the
EPA
preliminary
framework).
The
Fluoropolymers
Manufacturing
Group
(
FMG)
has
reviewed
this
document
with
respect
to
the
fluoropolymer
data
needs
outlined
in
Table
II
of
the
EPA
preliminary
framework
and
offers
the
comments
below
as
a
means
to
facilitate
development
of
consensus
fluoropolymers
ECAs.

Note
that
in
the
discussion
below,
Item
Numberpertains
to
the
Item
Number
listed
in
Table
IIof
the
EPApreliminary
framework.

°
Summary
For
the
most
part,
the
FMG
is
supportive
ofthe
work
detailed
in
the
EPA
preliminary
framework
for
fluoropolymers.
Our
level
of
support
is
demonstrated
by
inclusion
of
most
ofthese
items
in
the
LOIs
already
submitted
to
the
EPA,
along
with
many
other
supportive
documents
given
to
the
EPA
over
the
past
couple
of
years.
Our
detailed
response
to
each
individual
item
number
is
provided
below.

°
FMG
Response
to
Individual
Items
Item
1
Item
1
calls
for
"
comprehensive
fluoropolymer
market
information,
including
CAS
numbers,
chemical
names,
production
volumes/
import
volumes,
and
uses/
applications."
We
agree
that
this
type
ofinformation
is
needed
to
enhance
the
understanding
of
potential
sources
ofPFOA
in
the
environment
and
pathways
by
which
human
exposure
to
PFOA
may
be
occurring.

The
CAS
numbers
and
chemical
names
for
the
relevant
fluoropolymers
made
by
the
FMG
companies
are
included
in
Addendum
1
of
the
FMG
LOT.
1
The
uses,
applications,
and
benefits
of
fluoropolymers
are
covered
in
a
document2
submitted
to
this
docket
by
I
OPPT­
2003­
0012­
0012,
FMG
(
PFOA
Users)
Letter
of
Intent,
as
corrected
by
OPPT­
2003­
0012­
0034
2
OPPT­
2003­
OO
12­
0059
Benefits
of
Fluoropolymers
Manufactured
Using
PFOA
FMG
Response
June
5,
2003
Preliminary
ECA
Framework
Page
2
the
Society
ofthe
Plastics
Industry,
Inc.
(
SPI)
forthe
FMG
and
have
also
been
covered
in
other
informal
communications
to
EPA
on
end
use
applications.
3
EachFMG
member
company
will
provide
under
CBI
production
and
import
volumes
by
CAS
numbers
and
plant
locations.
Other
supporting
information
canbe
found
in
SRI
CEH
Marketing
Research
Reports
as
well
as
CEFIC
fluoropolymer
industry
sales
reports.
Copies
ofthe
latter
document
will
be
provided
by
the
FMG.

The
FMG
understands
the
need
for
information
covered
by
Item
1,
and
we
believe
we
have
already
provided
the
majority
ofthe
requested
information
in
Item
1.
Given
that
the
industry
group
volunteers
to
supply
the
remaining
information,
we
suggest
Item
1
may
not
need
to
be
included
in
an
ECA
for
the
FMG
companies.

Items
2,
3
and
4
Item
2
calls
for
"
P­
chem
properties
to
inform
fate
testing"
of
representative
fluoropolymers.
Item
3
calls
for
"
elucidation
of
degradation
pathways
and
identification
of
degradation
products"
for
representative
fluoropolymers.
Item
4
calls
for
the
"
determination
ofp­
chem,
fate
and
transport
properties
of
major
degradation
products,"
to
be
determined
based
on
test
results.
We
agree
that
this
type
ofinformation
would
be
called
for
in
any
generic
study
to
understand
potential
sources
of
a
particular
material
in
the
environment.

In
addition
to
the
information
already
provided
to
EPA,
additional
sources
are
provided
in
Appendix
A.

Given
the
public
availability
ofthe
information
requested
and
the
fact
that
the
information
does
not
support
degradation
offluoropolymers
as
a
potential
route
ofPFOA
exposure,
the
FMG
questions
whether
generation
of
the
requested
information
would
be
additive
to
understanding
potential
PFOA
exposure
routes.
The
FMG
member
companies
would
be
interested
in
further
discussing
this
activity
with
the
EPA.

Item
5
Item
5
calls
for
the
"
determination
ofPFOA
FPA
contamination
ofprocessed
fluoropolymer
(
solid),
including
a
detailed
material
balance
focusing
on
interstage
transfers
and
releases
to
environmental
compartments."
The
industry
group
agrees
that
this
determination
needs
to
take
place
and
as
such,
has
included
a
plan
to
do
so
in
the
LOl
submittals.

The
results
ofFMG
LOl
section
D­
2
for
polymer
resins
will
determine
if
any
PFOA
can
migrate
from
the
resin
and
quantify
the
amount.
Ifa
significant
quantity
were
found
to
migrate
from
the
dry
resin,
a
discussion
would
be
relevant
to
determine
the
fate
ofthe
material
in
polymer
processing.

3OPPT­
2003­
0012­
00109,
Fluoropolymer
End
Use
Applications
The
Society
ofthe
Plastics
Industry,
Inc.
Fluoropolymer
Manufacturers
Group
FMG
Response
June
5,
2003
Preliminary
ECA
Framework
Page
3
FMG
LOT
section
D­
4
signifies
the
FMG's
intent
to
conduct
article
of
commercetesting
to
determine
if
APFO
can
migrate
from
a
representative
sample
ofconsumer
and
industrial
articles
ofcommerce.
This
testing
will
be
conducted
using
approved
FDA
migration
testing
protocols,
with
the
FDA
recommended
solvents
as
judged
to
be
relevant
for
the
particular
application.
Since
water
is
the
only
FDA
recommended
solvent
that
has
an
analytical
protocol
with
the
required
QAIQC
capability,
a
significant
element
ofthis
effort
will
be
developing
validated
analytical
procedures.

FMG
LOI
section
D­
3
provides
forperforming
a
material
balance
for
fluoropolymer
dispersion
customers.
Since
PFOA
is
known
to
be
present
in
fluoropolymer
dispersions,
the
study
ofthe
fate
in
fluoropolymer
dispersion
processing
is
justified
at
this
time.

FMG
LOT
section
D­
2
calls
forwater
monitoring
and
air
modeling
at
a
representative
sample
ofthe
US
fluoropolymer
manufacturing
locations.
The
protocol
for
conducting
this
effort
will
be
based
on
the
work
conducted
by
DuPont
with
the
State
ofWest
Virginia.
This
protocol
was
developed
and
approvedby
the
States
of
West
Virginia
and
Ohio
and
EPA
Regions
3
and
5.

Since
the
FMG
believes
the
intent
ofItem
5
is
fully
met
in
the
LOI,
the
FMG
does
not
see
the
need
to
include
Item
5
in
an
ECA
at
this
time.
We
believe
it
would
be
more
appropriate
to
consider
inclusion
of
additional
work
in
this
area
in
an
ECA
once
the
results
ofthe
LOl
investigations
are
completed.

Item
6
Item
6
calls
for
determination
ofthe
"
presence
ofPFOA
in
fluoropolymer
and
fluoropolymer
treated
products
and
articles."
The
industry
group
supports
the
need
for
the
determination
for
the
presence
ofPFOA
in
fluoropolymer
articles
ofcommerce.

The
industry
group
has
identified
a
list
of
representative
products
and
has
committed
to
doing
this
analysis
in
FMG
LOT
section
D­
4.
We
fully
support
the
need
to
discuss
what
are
representative
articles
ofcommerce
and
include
those
articles
in
the
study
committed
to
under
section
D­
4
ofthe
FMG
LOT.
However,
as
a
whole,
the
list
suggested
in
Item
6
of
Table
II
is
not
considered
appropriate
since
fluoropolymers
are
not
used
in
most
ofthe
suggested
applications.
For
example,
FMG's
fluoropolymers
are
not
used
in
paper
and
carpet
products.

The
industry
group
does
fully
support
the
intent
of
Item
6,
but
does
not
understand
the
need
to
include
Item
6
in
the
ECA
process
since
our
understanding
is
that
the
intent
of
Item
6
is
fully
covered
in
the
FMG
LOT.

Item
7
Item
7
calls
for
determination
of
the
"
presence
of
PFOA
emitted
from
fluoropolymer
treated
products
and
articles
as
they
age
during
use."
The
test
substances
are
to
be
"
representative
fluoropolymers
from
manufacturers
and
importers
in
indoor
air
adjacent
The
Society
of
the
Plastics
Industry,
liw.
Fluoropolymer
Manufacturers
Group
FMG
Response
June
5,
2003
Preliminary
ECA
Framework
Page
4
to
 
and
dust
from
or
adjacent
to
 
carpet,
textile,
and
paper."
The
FMG
understands
that
fluoropolymers
are
generally
not
used
in
carpet
and
paper
applications.
However,
we
are
willing
to
discuss
this
with
EPA
to
discover
if
there
are
any
relevant
materials
to
test.

Item
8
Item
8
calls
for
"
determination
ofincineration
byproducts
offluoropolymer
and
fluoropolymer
treated
products
and
articles."
Although
some
information
is
available
on
incineration
offluoropolymers
and
this
information
is
publicly
available
in
the
SPI'
s
"
Guide
to
Safe
Handling
ofFluoropolymer
Resins,"
4
the
industry
group
supports
the
need
for
incineration
testing
to
better
characterize
potential
byproducts
from
fluoropolymer
incineration.
However,
discussion
to
gain
agreement
on
the
appropriate
materials
and
protocols
for
testing
needs
to
take
place
since
most
ofthe
applications
(
i.
e.,
paper
and
carpet)
suggested
in
the
EPA
preliminary
framework
document
do
not
contain
fluoropolymers.

Item
9
Item
9
calls
for
"
determination
ofp­
chem,
fate
and
transport
properties
of
incineration
products",
Industry
supports
a
commitment
to
study
the
results
ofincineration
testing
called
for
in
Item
8
and
to
determine
p­
chem,
fate
and
transport
of
any
incineration
products
that
can
reasonably
be
considered
a
precursor
to
APFO.

The
FMG
is
willing
to
consider
Item
9
in
an
ECA,
but
also
believes
that
the
need
for
Item
9
is
premature
and
speculative
at
this
time.
Once
the
results
of
Item
8
are
obtained,
the
FMG
is
willing
to
meet
with
the
EPA
and
assess
on
a
scientific
basis
whether
there
are
any
relevant
byproducts
that
need
p­
chem,
fate
and
transport
data
developed
and
are
generated
in
any
significant
quantity
to
justify
the
required
effort.

Item
10
Item
10
calls
for
"
release
and
exposure
assessments
adjacent
to
PFOA
and
fluoropolymer
manufacturing
and
use
facilities;
also
ofcontrol
areas".
The
FMG
fully
supports
the
need
for
release
and
exposure
assessments
adjacent
to
PFOA
and
fluoropolymer
manufacturing
and
use
facilities.

As
such,
per
Appendix
3
ofthe
FMG
LOT,
Dupont
has
committed
to
conduct
an
exposure
assessment
adjacent
to
its
APFO
manufacturing.
DuPont
has
also
submitted
a
complete
work
plan
for
this
effort
to
the
EPA
record
based
on
the
above­
referenced
work
plan
developed
in
West
Virginia.
5
Similarly,
in
FMG
LOI
section
D­
2,
the
FMG
has
committed
to
conduct
exposure
assessments
adjacent
to
a
representative
sample
of
fluoropolymer
manufacturing
facilities
in
the
US.
The
protocol
for
these
assessments
will
be
based
on
the
protocol
developed
~
AR226­
1064
~
Documents
previously
submitted
to
the
EPA.

The
Society
ofthe
Plastics
Industry,
Inc.
Fluoropolymer
Manufacturers
Group
FMG
Response
June
5,
2003
Preliminary
ECA
Framework
Page
5
and
approved
by
DuPont,
the
states
of
West
Virginia
and
Ohio,
along
with
Regions
3
and
5
of
the
US
EPA.
The
entire
work
plan,
quality
assurance
plan,
and
results
from
the
study
in
the
area
of
DuPont's
Washington
Works
have
been
submitted
to
the
EPA
record.
6
This
work
plan
includes
sampling
ofsurface
water,
as
well
as
groundwater
and
soil
sampling.

Finally,
in
FMG
LOT
section
D­
3,
the
FMG
has
committed
to
conduct
a
material
balance
assessment
at
representative
fluoropolymer
dispersion
processing
customers.
The
fluoropolymer
dispersion
customers'
assessment
will
be
based
on
an
industry­
developed
protocol
using
appropriate
methods
and
protocols.
For
example,
see
reference
OPPT­
2003­
0012­
0040.
Since
dry
resin
is
not
expected
to
contain
any
significant
amount
of
PFOA,
the
FMG
does
not
feel
it
would
be
appropriate
to
include
dry
resin
processors
at
this
time.
However,
the
FMGwould
be
willing
to
have
a
discussion
with
EPA,
to
review
the
final
reports
from
the
fluoropolymer
dispersion
processors
material
balance
and
the
articles
ofcommerce
testing
to
determine
if
this
perspective
needs
to
be
reconsidered.

The
FMG
supports
the
overall
intent
ofItem
10
and
believes
the
critical
elements
ofItem
10
are
included
in
the
LOT.
DuPont
has
also
provided
a
detailed
example
protocol
in
its
submittal
to
the
ECA
record.
By
reviewing
the
data
collected
in
the
area
ofDuPont's
Washington
Works
submittal
(
in
cooperation
with
the
states
ofWest
Virginia
and
Ohio,
and
the
US
EPA
Regions
3
and
5)
and
data
from
other
sites
currently
being
investigated,
the
FMG
is
of
the
opinion
that
Item
10
is
covered
in
the
FMG
LOT.
Nevertheless,
the
FMG
is
willing
to
discuss
those
results
when
available
with
a
view
towards
determining
what
additional
work,
if
any,
is
warranted.

Item
11
Item
11
calls
for
"
product
stewardship
information
concerning
PFOA
and
fluoropolymer
products
and
article
manufacture,
use,
and
disposal."
The
FMG
is
committed
to
providing
appropriate
product
stewardship
information
to
fluoropolymer
processors.

The
FMG
believes
our
LOI
provides
a
good
example
of
the
commitment
of
the
FMG
companies
to
assure
thorough
understanding
ofany
potential
product
stewardship
issues.
Additional
examples
ofthe
industry's
commitment
to
product
stewardship
are
evidenced
by
the
Guide
to
Safe
Handling
of
Fluoropolymer
Resins
and
the
Guide
to
the
Safe
Handling
ofFluoropolymer
Dispersions;
they
are
currently
in
AR226­
1064
and
AR226­
1063.
Along
with
the
above,
each
company
also
has
company
specific
MSDS
forms
that
further
cover
the
handling
and
use
of
fluoropolymers.
In
addition,
we
will
provide
the
Association
ofPlastics
Manufacturers
in
Europe
(
APME)
"
Guide
for
the
Safe
Handling
ofFluoropolymer
Resins"
2nd
edition:
January
2003.

The
FMG
believes
that
the
industry's
product
stewardship
programs
are
consistent
with
the
principles
ofResponsible
Care7
®
but
are
willing
to
meet
with
the
EPA
to
discuss
the
adequacy
of
its
efforts.

~
Documents
previously
submitted
to
the
EPA.
~
American
Chemistry
Council
"
Responsible
Care
®
Code
Book"

The
Society
ofthe
Plastics
Industry,
Inc.
Fluoropolymer
Manufacturers
Group
FMG
Response
Preliminary
ECA
Framework
June
5,
2003
Page
6
Appendix
A
1)
"
Modem
Fluoropolymers"
by
John
Scheirs
(
John
Wiley
&
Sons,
2002)
ISBN
0­
471­
97055­
7
2)
"
Technology
ofFluoropolymers"
by
Jiri
George
Drobny,
(
CRC
Press,
2001)
ISBN
0­
8493­
0246­
3
3)
"
Fluoroplastics:
vol.
1
&
2",
Sina
Ebnesajjad,
(
Plastic
Design
Library,
2000
&
2003)
ISBN
1­
884207­
84­
7
&
ISBN
1­
884207­
96­
0
4)
"
Encyclopedia
ofPolymer
Science
&
Engineering",
2nd
ed.,
(
John
Wiley
&
Sons,
1989)
5)
"
Kirk­
Othmer
Encyclopedia
of
Chemical
Technology"
4th
ed.,
(
John
Wiley
&
Sons,
1994)
6)
"
The
Guide
to
the
Safe
Handling
of
Fluoropolymer
Resins"
3
rd
ed.,
(
Fluoropolymers
Division,
The
Society
of
the
Plastics
Industry,
Inc.,
1998)

The
Society
ofthe
Plastics
Industry,
Inc.
Fluoropolymer
Manufacturers
Group