Document ID: EPA-HQ-OPPT-2003-0012-0036
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-05-14T04:00Z

May
5,
2003
Wardner
G.
Penberthy
Director,
Chemical
Control
Division
Office
of
Pollution,
Prevention
&
Toxics
U.
S.
Environmental
Protection
Agency
Ariel
Rios
Building,
7405M
1200
Pennsylvania
Avenue,
N.
W.
Washington,
DC
20460
Dear
Mr.
Penberthy:

Re:
Follow­
up
Questions
Regarding
APFO
Users'
LOI
Commitments
This
letter
is
in
response
to
your
e­
mail
dated
April
30,
2003,
requesting
more
detail
on
certain
aspects
of
the
APFO
Users'
Letter
of
Intent
(
LOI)
dated
March
13,
2003.
Specifically,
you
requested
detailed
descriptions
of
the
plant
site
environmental
monitoring
studies
and
Articles
of
Commerce
Test
Program
described
in
the
LOI,
as
well
as
clarification
of
plans
for
environmental
monitoring
at
the
site
of
APFO
manufacture.

This
letter
will
address
the
general
questions
concerning
the
environmental
studies
at
fluoropolymer
manufacturing
sites
and
the
questions
concerning
the
Articles
of
Commerce
Test
Program.
The
questions
will
be
answered
in
a
point­
by­
point
format.

Separate
letters
from
the
individual
APFO
Users
whose
plant
sites
are
listed
in
our
LOI
will
address
the
questions
concerning
specific
details
of
the
environmental
studies
at
the
fluoropolymer
manufacturing
facilities.

The
current
APFO
manufacturer
will
address
the
questions
concerning
the
plans
for
environmental
monitoring
at
the
site
of
APFO
manufacture.

Follow­
up
Questions
Regarding
APFO
Users'
LOI
Commitments
LOI
page
7
item
2
3)
"
as
necessary
....
conduct
ground
and
surface
water
analysis
and
assess
results
using
the
water
screening
levels..."

Site­
specific
studies
will
be
developed
to
evaluate
potential
PFOA
levels
in
water
within
the
site
boundaries.
Each
participant
will
use
an
air
dispersion
model,
initial
site
water
monitoring
data
and
the
screening
levels
established
in
the
DuPont/
West
Virginia
consent
order
to
determine
any
additional
sampling
locations
outside
the
site
boundaries.
If
the
initial
results
indicate
the
need
for
expanded
sampling,
a
phased
sampling
plan,
based
on
distance
from
the
source,
will
be
developed.
Each
participant
will
independently
submit
site­
specific
plans,
including
testing
frequency.
 
What
criteria
will
be
used
to
determine
if
it
is
"
necessary"
to
collect
water
samples?
o
Each
participant
will
collect
preliminary
water
samples
to
develop
a
sitespecific
assessment
of
potential
PFOA
levels
in
water
around
each
site.

 
How
many
samples
will
be
analyzed
from
each
location
and
what
is
the
sampling
strategy?
o
Each
participant
will
submit
site­
specific
plans
that
will
include
sampling
of
on­
site
wells,
discharge
streams,
outfalls
and
downstream/
upstream
locations.

 
What
test
method
(
standard)
will
be
used
to
analyze
the
samples
(
e.
g.,
ASTM,
EPA,
OECD,
other
specify)?
o
The
validated
Exygen
Research
analytical
laboratory
method
(
01M­
008­
046
revision
1)
will
be
used.
DuPont
will
submit
a
copy
of
the
method
by
May
12,
2003.

 
Will
PFOA
precursors
and/
or
other
constituent
components
of
the
product
mixtures
be
analyzed
for
in
addition
to
APFO/
PFOA?
If
so
which
ones?
o
Each
participant
will
analyze
for
PFOA
anion
species,
all
of
which
are
detected
by
the
validated
method.

 
What
is
the
accuracy
and
precision
of
the
test
method?
o
The
test
method
as
submitted
by
DuPont
describes
the
accuracy
and
precision.

 
Has
the
test
method
been
validated?
o
Yes.

 
Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
If
so,
please
provide
a
copy.
o
Yes.
DuPont
will
submit
analytical
methods
and
sample
handling
procedures.
o
Copies
will
be
provided
by
May
12,
2003.
 
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
i.
e.
to
AR226
or
8(
e)),
please
identify
the
submission.
o
Copies
will
be
provided
by
May
12,
2003.

 
What
is
the
timing
of
this
work?
o
Preliminary
reports
will
be
submitted
by
September
15,
2003,
by
each
participant.

LOI
page
10
item
4
1)
and
2)
"
analyze
representative
articles
of
commerce
containing
or
made
with
dry
fluoropolymer
resins
for
the
presence
of
APFO"
and
"
for
products
coated
or
manufactured
with
liquid
dispersions,
analyze
representative
articles
of
commerce
for
presence
of
APFO"

 
How
will
representative
products
be
selected?
o
The
intent
of
this
study
is
to
document
and
confirm
that
fluoropolymer
articles
of
commerce
are
not
a
likely
source
of
PFOA.
The
articles
of
commerce
are
chosen
using
the
following
criteria:

Each
representative
article
of
commerce
will
contain
a
fluoropolymer
made
using
PFOA.

Representative
articles
will
be
selected
to
represent
a
cross
section
of
article
manufacturing
processes
and
end­
use
markets.

Articles
selected
will
encompass
widely
recognized
consumer
applications
and
high­
volume
industrial
applications.
 
What
criteria
will
be
used
to
determine
which
products
are
"
representative"?
o
See
above
response.
 
How
many
samples
of
each
representative
product
will
be
analyzed
and
what
is
the
sampling
strategy?
o
It
is
our
intent,
within
the
bounds
of
anti­
trust
restraints,
to
sample
approximately15
different
application
categories
by
the
following:

Identify
two
customers
for
each
application,

Obtain
two
article
samples
from
each
customer,
for
each
application,

Conduct
triplicate
analyses
per
sample.
 
Will
the
number
of
articles
analyzed
be
sufficient
to
make
a
judgment
about
the
overall
contribution
of
fluoropolymer
treated
articles
to
PFOA
in
the
environment?
o
Yes.
Based
on
our
industry
experience,
the
number
of
articles
analyzed
will
be
sufficient.
 
What
test
method
(
standard)
will
be
used
to
analyze
the
samples
(
e.
g.,
ASTM,
EPA,
OECD,
other
specify)?
o
A
method
that
determines
migration
using
the
water­
based
extraction
protocol:
FDA
21
CFR
175.300
(
d)
Table
2
Condition
of
Use
"
B"
o
The
validated
Exygen
Research
analytical
laboratory
method
(
01M­
008­
046
revision
1)
will
be
used.
DuPont
will
submit
a
copy
of
the
method
by
May
12,
2003.
 
Will
PFOA
precursors
and/
or
other
constituent
components
of
the
product
mixtures
be
analyzed
for
in
addition
to
APFO/
PFOA?
If
so
which
ones?
o
The
participants
will
analyze
for
PFOA
anion
species,
all
of
which
are
detected
by
the
validated
method.
 
What
is
the
accuracy
and
precision
of
the
test
method?
o
The
test
method
as
submitted
by
DuPont
describes
the
accuracy
and
precision.
 
Has
the
test
method
been
validated?
o
Yes.
 
What
is
the
reporting
criteria
for
the
constituent
components
that
will
be
reported?
o
Only
PFOA
will
be
reported
 
Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
o
The
collection
logistics
and
chain
of
custody
procedure
is
being
developed
and
documented.
o
The
extraction
and
analytical
procedures
are
already
completed
(
FDA
21
CFR
175.300
(
d)
Table
2
Condition
of
Use
"
B"
and
Exygen
Research
analytical
laboratory
method
[
01M­
008­
046
revision
1]).
 
If
so,
please
provide
a
copy.
o
Procedures
under
development
will
be
submitted
when
available.
DuPont
will
submit
the
extraction
protocol
and
analytical
procedure
by
May
12,
2003.
 
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
i.
e.
to
AR226
or
8(
e)),
please
identify
the
submission.
o
Not
as
of
this
date.
 
What
is
the
timing
of
this
work?
o
A
final
report
will
be
submitted
by
the
end
of
2003,
per
the
LOI
LOI
Addendum
III
item
4)
"
monitor
groundwater
and
surface
water
for
APFO
in
the
vicinity
of
the
facility"
The
answers
to
these
questions
will
be
submitted
by
the
APFO
manufacturer
under
separate
cover.

The
APFO
Users
appreciate
this
opportunity
to
work
with
the
EPA
on
this
LOI
and
on
our
prior,
ongoing
and
future
product
stewardship
measures
for
PFOA
used
in
the
manufacture
of
fluoropolymers.
We
look
forward
to
dialogue
with
the
EPA
regarding
the
content
of
this
letter.

Please
contact
me
if
you
have
any
questions.

Sincerely,

Don
Duncan,
President
The
Society
of
the
Plastics
Industry,
Inc.