Document ID: EPA-HQ-OPPT-2003-0012-0049
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-05-14T04:00Z

TRP
(
9­
May­
03)

TELOMER
RESEARCH
PROGRAM
Response
to
EPA
Follow­
up
Questions
Regarding
TRP
LOI
Commitments
The
members
of
the
Telomer
Research
Program
(
TRP)
1
submitted
a
Letter
of
Intent
(
LOI)
2
to
EPA
dated
March
14,
2003
that
outlined
our
voluntary
commitment
to
investigate
whether
and
how
telomer­
based
products
can
transform
or
break
down
into
perfluorooctanoic
acid
(
PFOA)
or
its
salts,
and
whether
articles
treated
with
such
products
contribute
to
significant
human
or
environmental
exposure
to
PFOA.
The
focus
of
the
LOI
is
on
research,
analysis
and
product
stewardship
activities
that
can
be
conducted
in
the
near
term
with
expected
results
in
2003
and
2004.

In
a
letter
dated
April
30,
2003,
EPA
requested
the
TRP
to
provide
a
detailed
description
of
the
various
testing
activities
that
are
described
in
the
LOI.
In
particular,
EPA
requested
clarification
on
the
items
listed
below
(
EPA
questions
are
in
italics).
The
TRP
is
providing
responses
to
each
of
the
follow­
up
questions
in
addition
to
reference
documents
that
provide
additional
detail.

Product
and
Article
Analysis
(
LOI
Item
1,
page
3)

The
TRP
is
conducting
a
study
to
analyze
for
the
presence
of
PFOA
in
representative,
major
end­
use
telomer­
based
polymeric
products
in
commerce
and
articles
treated
with
those
products.
We
have
contracted
with
an
outside
research
laboratory
to
perform
this
work.
This
screening
study
will
investigate
levels
of
PFOA
in
articles
for
three
major
end­
use
categories:
carpets,
textiles
and
paper.
The
primary
products
that
TRP
members
market
for
these
applications
are
polymers,
which
represent
approximately
85%
of
the
telomer­
based
products
that
the
TRP
members
manufacture
and
sell.
The
product
types
to
be
tested
are
those
that
the
TRP
member
companies
manufacture
as
actual
items
of
commerce.
The
treated
articles
to
be
tested
are
actual
carpet,
textile,
and
paper
substrates
treated
under
representative
mill
conditions
with
the
subject
telomer­
based
polymeric
products.

Product
Types:
acrylate
and
urethane
polymers
(
12
representative
products)

The
TRP
prepared
a
study
plan
describing
the
scope
and
rationale
for
the
"
Analysis
of
Telomer­
Based
Products
and
Telomer­
Treated
Articles."
The
study
plan
was
submitted
to
EPA
on
March
31,
2003.
The
TRP
also
developed
a
document
on
"
LC/
MS/
MS
Analysis
of
Articles
and
Products:
Samples
and
Suggested
Sampling
Procedures"
(
submitted
to
EPA
on
February
14,
2003).
Much
of
the
information
provided
below
is
drawn
from
these
two
reference
documents
with
further
elaboration
as
appropriate
to
incorporate
new
developments
in
the
study
and
modifications
to
the
study
plan
as
the
work
progresses.
A
more
detailed
description
or
explana­
tion
can
be
provided
to
EPA
staff
if
desired.

1
The
companies
participating
in
the
TRP
include
Asahi
Glass,
Clariant
GmbH,
Daikin
Industries,
and
E.
I.
duPont
de
Nemours
&
Company.
These
companies
produce
or
import
fluorotelomer­
based
products,
which
are
used
as
fluorosurfactants
and
surface
protection
chemicals.
Telomers
are
not
made
from
PFOA,
nor
is
PFOA
added
during
the
manufacture
or
use
of
telomer
products.

2
TRP
Letter
of
Intent
 
EPA
Docket
#
OPPT­
2003­
0012­
0013.

1
TRP
(
9­
May­
03)

Significance
/
Expected
Outcome:
The
results
from
this
screening
study
will
provide
a
compre­
hensive
initial
picture
of
exposure
potential
by
focusing
on
these
major
end­
use
telomer­
based
polymeric
products
and
the
corresponding
articles
of
commerce.

How
will
representative
products
and
articles
be
selected?
What
criteria
will
determine
which
products
and
articles
are
"
representative"?

Representative
major
telomer­
based
polymeric
products
in
commerce
and
articles
treated
with
those
products
will
be
tested.
Investigations
will
be
conducted
on
12
telomer­
based
polymeric
end­
use
products
used
to
treat
three
major
end­
use
product
categories:
carpet,
textile
and
paper.
Four
of
the
12
telomer­
based
polymeric
products
will
be
used
to
treat
carpet;
six
of
the
12
telomer­
based
products
will
be
used
to
treat
textiles
and
two
of
the
12
telomer­
based
products
will
be
used
to
treat
paper.
Six
sub­
samples
from
each
of
the
12
treated
articles
will
be
prepared
using
a
random­
block
approach
or
alternatively
six
individual
samples
will
be
prepared
using
identical
lots
of
telomer­
based
polymeric
products
and
articles
of
commerce.

While
there
are
many
potential
telomer­
based
polymeric
products,
a
relatively
small
number
represent
the
primary
product
classes
in
commerce
(
12
representative
products).
The
selected
12
products
represent
the
product
types
used
to
serve
the
designated
market
end
uses
of
carpet,
textile
and
paper.
The
treated
articles
to
be
tested
are
actual
carpet,
textile,
and
paper
substrates
treated
under
representative
or
actual
mill
conditions
with
the
subject
telomer­
based
polymeric
products.

Will
the
number
of
products
and
articles
analyzed
be
sufficient
to
make
a
judgment
about
the
overall
contribution
of
telomer
products
and
articles
to
PFOA
in
the
environment?

The
number
of
products
and
articles
chosen
to
be
analyzed
will
provide
an
important
basis
for
evaluating
the
level
of
PFOA
in
products
and
articles.
If
the
results
of
these
tests
show
no
significant
level
of
PFOA,
then
it
is
a
reasonable
assumption
that
neither
products
nor
articles
are
contributing
PFOA
to
the
environment.
However,
when
the
accuracy
and
variability
of
the
method
is
established
and
actual
levels
of
PFOA
are
quantified,
then
the
TRP
data
will
be
sufficient
to
make
a
judgment
about
the
overall
contribution
of
telomer­
based
product
and
articles
to
PFOA
in
the
environment.

What
are
the
chemical
identities
of
the
products?

The
chemical
identities
of
the
selected
representative
polymers,
volumes,
and
their
relative
market
share
are
consistent
with
information
provided
to
EPA
in
the
submissions
from
TRP
member
companies
in
March
2003.
TRP
companies
will
also
provide
EPA
(
under
CBI)
specific
information
­­
such
as
structures,
CAS
numbers,
chemical
names,
2002
uses
and
volumes
in
commerce
­­
on
other
telomer
products
used
in
the
United
States
(
including
non­
polymeric
products)
by
the
end
of
May
2003.

We
have
received
test
methods
from
TRP
for
both
products
(
chemicals)
and
articles.
Has
either
method
ever
been
used
before?

2
TRP
(
9­
May­
03)

The
TRP
developed
a
document
on
"
LC/
MS/
MS
Analysis
of
Articles
and
Products:
Samples
and
Suggested
Sampling
Procedures"
(
submitted
to
EPA
on
February
14,
2003).
This
document
is
an
outline
for
the
development
of
test
methods
for
PFOA
for
both
products
and
articles.

The
test
method
for
PFOA
in
articles
is
under
development
and
should
be
completed
by
June
2003.
The
test
method
development
for
PFOA
in
telomer­
based
polymeric
products
will
be
initiated
after
completion
of
the
method
for
telomer­
treated
articles.
Neither
method
has
been
used
before
for
the
analysis
of
PFOA
in
treated
articles
and
telomer­
based
polymeric
product.

Can
you
update
us
on
the
validation
status
and
accuracy
and
precision
of
each
test
method?

Our
current
target
is
recovery
of
PFOA
from
actual
article
samples
at
the
1
ppb
level
of
quantitation
(
LOQ).
This
quantitation
level
has
not
yet
been
achieved
due
to
problems
encountered
with
contamination,
the
requirement
to
include
differentiation
of
linear
and
branched
PFOA
in
the
quantitation,
and
refinement
of
overall
chromatographic
conditions.
Given
the
difficulties
encountered,
we
are
contacting
other
laboratories
for
potential
involvement
in
this
work.

Method
development
for
products
will
be
initiated
as
soon
as
the
issues
for
articles
have
been
resolved.
The
learnings
from
the
method
development
for
articles
are
expected
to
be
applicable
for
product
analysis.

Will
PFOA
precursors
such
as
free
telomer
alcohols
be
analyzed
for
in
addition
to
PFOA?
If
so,
which
ones?

At
this
time,
our
current
focus
is
on
determining
if
PFOA
is
present
in
telomer­
based
polymeric
products
and
articles
treated
with
those
products.

Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
If
so,
please
provide
a
copy.
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
ie.
to
AR226
or
8(
e)),
please
identify
the
submission.

The
TRP
developed
a
document
on
"
LC/
MS/
MS
Analysis
of
Articles
and
Products:
Samples
and
Suggested
Sampling
Procedures"
(
submitted
to
EPA
on
February
14,
2003).
This
document
provides
guidance
for
the
sampling
and
analysis
of
samples.

What
is
the
timing
of
this
work?

During
the
months
of
January
and
February
2003,
appropriate
sampling
shipment
and
analysis
procedures
as
well
as
primary
and
internal
standards
for
this
work
were
prepared
while
contract
laboratory
selection
made.
After
characterization
of
the
internal
standard
and
arrival
of
the
samples,
method
development
was
initiated
in
March
2003.
Method
development
efforts
were
unexpectedly
diverted
to
address
apparent
PFOA
contamination
which
prohibited
achieving
low
level
LOQ
for
PFOA
in
untreated
articles.
Additional
samples
of
untreated
articles
needed
to
be
prepared
and
shipped.
Subsequently,
efforts
focused
on
separating
branched
from
linear
PFOA
as
well
as
optimizing
chromatographic
conditions
for
1
ppb
LOQ.
New
sets
of
untreated
articles
(
controls)
are
scheduled
to
arrive
early
May
2003.

3
TRP
(
9­
May­
03)

By
June
2003,
method
development
and
method
validation
on
articles
will
be
completed.
Article
analysis
will
be
completed
in
early
July
2003.
Method
evaluation
on
products
and
actual
product
analyses
will
be
conducted
in
early
August
2003.
Final
reports
for
these
projects
will
be
available
in
September
2003.

Analysis
of
"
Aged"
Products
and
"
In
Use"
Articles
(
LOI
Item
2,
page
3)

The
TRP
will
commission
a
study
in
May
/
June
2003
to
examine
transformation
of
end­
use
telomer­
based
polymeric
products
for
potential
PFOA
generation
that
might
occur
through
storage
of
the
product
over
time
or
through
normal
use
of
treated
articles.
TRP
has
developed
a
draft
work
plan
for
conducting
PFOA
"
aging"
and
"
in
use"
analyses
of
the
specific
products
and
treated
articles
that
are
the
subject
of
the
TRP­
sponsored
work
in
LOI
Item
1
above
(
submitted
separately
to
EPA
for
review
and
comment
on
May
9,
2003).
For
these
analyses,
"
aged"
means
the
likely
conditions
our
products
will
see
under
normal
storage
and
distribution.
"
In­
use"
means
the
conditions
treated
articles
will
see
under
normal
distribution
and
use.
Potential
contract
labs
with
processing
capabilities
and
relevant
experience
are
being
investigated.
Study
protocols,
analytical
methods
and
appropriate
test
conditions
still
need
to
be
developed
for
this
work
Significance
/
Expected
Outcome:
This
work
is
expected
to
give
a
further
understanding
of
potential
changes
in
PFOA
levels
in
both:
 
Telomer­
based
polymeric
products
while
stored
prior
to
application
on
articles,
and
 
Treated
articles
under
normal
use
conditions.

How
many
products
and
articles
will
be
analyzed?

Following
the
rationale
developed
for
Product
and
Article
Analysis
(
LOI
Item
1),
twelve
(
12)
telomer­
based
polymeric
products
will
be
tested.
These
12
products
are
those
marketed
and
sold
for
use
in
three
major
end­
use
article
categories:
carpets,
textiles,
and
paper.
The
telomer­
based
polymeric
product
classes
to
be
tested
are
those
that
the
respective
TRP
member
companies
manufacture
as
actual
items
of
commerce.

The
current
work
plan
calls
for
"
in
use"
articles
representative
of
the
12
telomer­
based
polymeric
products
to
be
initially
evaluated
by
elevated
temperature
and
photolysis.
This
representation
consists
of
12
different
article
samples:
carpet
(
4
articles),
textiles
(
6
articles)
and
paper
(
2
articles).
The
current
work
plan
also
calls
for
triplicate
analyses
of
each
article
sample.

How
will
representative
products
and
articles
be
selected?

This
LOI
item
uses
the
same
rationale
for
selection
of
representative
telomer­
based
polymeric
products
and
treated
articles
as
for
LOI
Item
1.
That
is,
at
the
respective
TRP
member
manufacturing
sites,
representative
telomer­
based
polymeric
product
samples
will
be
collected
and
sealed
immediately
and
sent
to
the
selected
contractor
for
laboratory
analysis.

Samples
of
the
12
telomer­
treated
articles
will
be
collected
from
pilot
plant
facilities
or
from
commercial
manufacturing
facilities.

4
TRP
(
9­
May­
03)

Will
the
number
of
products
and
articles
analyzed
be
sufficient
to
make
a
judgment
about
the
overall
contribution
of
telomer
products
and
articles
to
PFOA
in
the
environment
through
this
pathway?

The
number
of
products
and
articles
chosen
to
be
analyzed
will
provide
an
important
basis
for
evaluating
the
level
of
PFOA
in
products
and
articles.
If
the
results
of
these
tests
show
no
significant
level
of
PFOA,
then
it
is
a
reasonable
assumption
that
neither
products
nor
articles
are
contributing
PFOA
to
the
environment.
However,
when
the
accuracy
and
variability
of
the
method
is
established
and
actual
levels
of
PFOA
are
quantified,
then
the
TRP
data
will
be
sufficient
to
make
a
judgment
about
the
overall
contribution
of
telomer­
based
products
and
articles
to
PFOA
in
the
environment.

What
are
the
chemical
identities
of
the
products?

The
telomer­
based
polymeric
products
being
tested
in
the
"
Aging
and
In
Use
Study"
are
the
same
as
in
the
"
Product
and
Article
Analysis"
under
LOI
Item
1.
Information
on
the
chemical
identities
of
the
products
has
been
provided
to
EPA
by
the
TRP
member
companies
(
under
CBI);
completed
in
March
2003.

How
will
products
and
articles
be
"
aged"?

The
selected
telomer­
based
polymeric
products
will
be
"
aged"
by
storage
at
45
°
C
and
triplicate
samples
will
be
analyzed
at
the
following
time
intervals:
0
day,
2
weeks,
6
weeks,
and
12
weeks.

The
temperature
of
45
°
C
was
selected
to
accelerate
the
aging
process
by
simulating
12
months
of
room
temperature
shelf
conditions
using
higher
temperatures
for
a
shorter
period
of
time.
The
assumption
is
that
the
fairly
moderate
temperature
of
45
°
C
will
create
degradation
patterns
similar
to
those
typical
at
room
temperature.
Samples
of
each
product
will
be
held
at
ambient
temperature
and/
or
at
4
°
C
as
a
potential
reference
points
should
they
be
required.

As
telomer­
based
polymeric
products
are
typically
stored
in
drums
which
allow
no
exposure
to
light,
photolytic
degradation
of
sales
products
will
not
be
tested.

In
order
to
simulate
"
use"
in
treated
articles,
a
variety
of
tests
will
be
conducted.

1.
Temperature
aging
on
treated
carpet,
textiles
and
paper
(
see
below
and
Section
3.4
of
the
work
plan
for
more
detail)
2.
Photolytic
aging
on
treated
carpet,
textiles
and
paper
(
see
below
and
Section
3.5
of
the
work
plan
for
more
detail)
3.
Abrasion
on
treated
carpet
and
textiles
(
see
below
and
Section
3.6
of
the
work
plan
for
more
detail)
4.
Washing
on
treated
textiles
(
see
below
and
Section
3.7
of
the
work
plan
for
more
detail)
5.
Dry
cleaning
on
treated
textiles
(
see
below
and
Section
3.8
of
the
work
plan
for
more
detail)
6.
Hot
water
extraction
cleaning
on
treated
carpet
(
see
below
and
Section
3.9
of
the
work
plan
for
more
detail)

5
TRP
(
9­
May­
03)

What
test
method
will
be
used
to
analyze
the
samples?
(
Will
it
be
the
same
test
method
as
in
item
1?)

The
same
PFOA
test
methods
developed
and
validated
under
Product
and
Article
Analysis
(
LOI
Item
1)
will
be
used
for
these
studies.

What
is
the
test
method's
validation
status
and
its
accuracy
and
precision?

Our
current
target
is
recovery
of
PFOA
from
actual
article
samples
at
the
1
ppb
level
of
quantita­
tion
(
LOQ).
This
quantitation
level
has
not
yet
been
achieved
due
to
problems
encountered
with
contamination,
the
requirement
to
include
differentiation
of
linear
and
branched
PFOA
in
the
quantitation,
and
refining
overall
chromatographic
conditions.
Given
the
difficulties
encountered,
we
are
contacting
other
laboratories
for
potential
involvement
with
this
work.

Method
development
for
products
will
be
initiated
as
soon
as
the
issues
for
articles
have
been
resolved.
The
learnings
from
the
method
development
for
articles
are
expected
to
be
applicable.
for
products.

Will
PFOA
precursors
such
as
free
telomer
alcohols
be
analyzed
for
in
addition
to
PFOA?
If
so,
which
ones?

At
this
time,
our
current
focus
is
to
determine
if
PFOA
is
present
in
telomer­
based
polymeric
product
and
articles
treated
with
those
products.

Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
If
so,
please
provide
a
copy.
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
ie.
to
AR226
or
8(
e)),
please
identify
the
submission.

A
consolidated
overview
of
the
procedures
is
given
in
the
proposed
work
plan,
"
Analysis
of
"
Aged"
Telomer­
Based
Polymeric
Products
and
"
In
Use"
Treated
Articles"
(
submitted
to
EPA
on
May
9,
2003).
The
detailed
descriptions
of
each
of
the
eight
proposed
procedures
will
be
submitted
separately
as
the
work
progresses.
Briefly,
the
basic
procedures
are
as
follows.

1.
PFOA
analysis
in
telomer­
based
polymeric
products
before
and
after
accelerated
aging
via
elevated
temperature
will
be
conducted.
(
See
Section
2.3
of
the
work
plan
for
more
detail)
2.
PFOA
analysis
before
and
after
temperature
aging
on
treated
carpet,
textiles
and
paper
will
be
conducted.
Treated
samples
of
carpet,
textiles
and
paper
will
be
analyzed
for
detectable
levels
of
PFOA.
Samples
will
then
be
subject
to
accelerated
aging
in
closed
containers
at
45
°
C
with
periodic
"
whole
container"
analysis
for
PFOA
over
a
time
period
of
12
weeks
(
equivalent
to
approximately
1
year
at
25
°
C).
The
use
of
closed,
whole
container
analysis
should
represent
the
cumulative
effect
of
aging
over
time.
At
each
sampling
interval,
control
samples
stored
at
ambient
temperature,
will
be
fortified
with
PFOA;
both
control
samples
and
fortified
samples
will
be
analyzed
to
demonstrate
that
acceptable
recoveries
are
obtained,
proving
the
method
is
working
correctly.
(
See
Section
3.4
of
the
work
plan
for
more
detail)

6
TRP
(
9­
May­
03)

3.
PFOA
analysis
before
and
after
photolytic
aging
on
treated
carpet,
textiles
and
paper
will
be
conducted.
Treated
samples
of
carpet,
textiles
and
paper
will
be
analyzed
for
detectable
levels
of
PFOA.
Samples
will
then
be
subject
to
Xenon
lamp
irradiation
in
closed
containers
at
25
°
C
with
whole
container
analysis
for
PFOA.
Non­
irradiated
untreated
samples
will
be
fortified
with
PFOA;
these
fortifications
along
with
the
non­
irradiated,
untreated
controls
will
be
analyzed
simultaneously
with
the
samples
(
both
non­
irradiated
and
irradiated)
to
demonstrate
that
acceptable
recoveries
are
obtained.
The
"
ASTM's
Paper
Aging
Research
Program"
(
report
March
12,
2002
version)
found
that
natural
sunlight
paper
brightness
loss
(
yellowing)
could
be
correlated
with
that
of
the
Xenon
lamp
when
the
Xenon
lamp
time
scale
was
multiplied
by
300.
Therefore
one
Xenon
lamp
irradiation
day
is
equivalent
to
about
1
year
of
natural
sunlight.
(
See
Section
3.5
of
the
work
plan
for
more
detail)
4.
PFOA
analysis
before
and
after
abrasion
on
treated
carpet
and
textiles
will
be
conducted
if
sufficiently
quantifiable
levels
of
PFOA
are
present.
The
AATCC
Test
Method
119­
1994
using
the
Screen
Wire
method
is
currently
proposed
to
simulate
abrasion
on
textiles.
The
Vetterman
Drum
test
is
currently
proposed
for
simulating
abrasion
on
carpet.
(
See
Section
3.6
of
the
work
plan
for
more
detail)
(
Note:
AATCC
=
American
Association
of
Textile
Chemists
and
Colorists)
5.
PFOA
analysis
before
and
after
washing
of
treated
textiles
will
be
conducted
using
one
set
of
conditions
described
in
the
AATCC
Test
Method
135­
1995,
"
Dimensional
Changes
in
Automatic
Home
Laundering
of
Woven
and
Knit
Fabrics",
if
sufficiently
quantifiable
levels
of
PFOA
are
present.
(
See
Section
3.7
of
the
work
plan
for
more
detail)
6.
PFOA
analysis
before
and
after
dry
cleaning
of
treated
textiles
will
be
conducted
using
conditions
described
in
the
AATCC
Test
Method
132­
1995
if
sufficiently
quantifiable
levels
of
PFOA
are
present.
(
See
Section
3.8
of
the
work
plan
for
more
detail)
7.
PFOA
analysis
before
and
after
hot
water
extraction
cleaning
on
treated
carpet
will
be
conducted
using
conditions
described
in
the
AATCC
Test
Method
171­
1995
if
sufficiently
quantifiable
levels
of
PFOA
are
present.
(
See
Section
3.9
of
the
work
plan
for
more
detail)
8.
PFOA
volatility
will
not
be
specifically
tested
as
part
of
this
LOI
Item
unless
dramatic
unexplained
PFOA
losses
are
observed;
other
sections
of
the
LOI
are
designed
to
explore
volatility
further.

What
is
the
timing
of
this
work?

April
 
May
2003
 
Developed
draft
work
plan
for
telomer­
based
polymeric
product
aging
and
treated
article
"
in­
use"
simulation
May
 
June
2003
 
Prepare
individual
draft
protocols
for
PFOA
analysis
on
aged
telomer­
based
polymeric
products
and
treated
article
"
in­
use"
and
locate
suitable
laboratories
July
 
August
2003
 
Initiate
elevated­
temperature
studies
on
telomer­
based
polymeric
products
and
treated
articles
7
TRP
(
9­
May­
03)

 
Review
data
on
PFOA
in
treated
articles
prior
to
in­
use
simulation
and
assess
the
need
and
viability
of
conducting
abrasion,
dry
cleaning,
washing,
steam
cleaning,
and
volatility
studies,
 
Initiate
article
"
in­
use"
studies
if
appropriate
September
2003
 
Initiate
photolysis
study
on
treated
articles.
 
Complete
validation
of
procedures
to
be
used
at
the
"
in­
use"
laboratories
November
2003
 
Submit
Photolysis
report
January
2004
 
Submit
Elevated­
Temperature
reports
 
Submit
"
in­
use"
reports
Characterizing
Potential
Releases
of
PFOA
from
Telomer­
Treated
Article
Manufacture
(
LOI
Item
4,
page
4)

The
TRP
members
will
examine
the
potential
for
PFOA
releases
and/
or
occupational
exposures
at
US
facilities
that
manufacture
telomer­
treated
articles.
This
information
will
be
assembled
through
a
release
estimate
model
analysis
directed
at
manufacture
of
the
three
primary
telomer­
treated
article
types
 
carpet,
textiles
and
paper
 
that
are
addressed
in
other
TRP
workstreams.

Work
is
underway
to
develop
estimates
of
potential
release
of
PFOA
related
to
manufacture
of
the
primary
article
types
(
carpet,
textiles
and
paper).
In
this
analysis
we
will
attempt
to
identify
potential
release
points,
exposure
pathways,
and
ultimate
environmental
compartments
(
air,
land,
water)
for
potential
PFOA
emissions
from
telomer­
treated
article
manufacturing
processes.
The
TRP
is
using
the
3M
product
use
/
exposure
template
(
Ref.
AR226­
0554).
Release
scenarios
will
be
developed
based
on
these
results.

The
release
estimate
analysis
will
be
used
to
first
design
and
then
conduct
mill
simulations
of
the
potential
release
of
PFOA
from
telomer­
treated
article
manufacturing
operations.
The
required
sampling
and
analytical
methods
for
PFOA
in
the
mill
simulations
must
first
be
developed
and
demonstrated.
A
contract
laboratory
capable
of
simulating
the
actual
mill
environment
under
defined
and
known
conditions
will
be
used
to
verify
the
data
generated
in
the
above
release
estimate
study.
The
results
from
the
analysis
and
simulations
will
be
used
to
estimate
the
potential
occupational
and
environmental
exposure
to
PFOA
from
the
specified
telomer­
treated
article
manufacturing
processes.

Significance
/
Expected
Outcome:
Together
with
the
Product
and
Article
Analysis
(
Item
1),
this
work
is
expected
to
provide
a
more
comprehensive
picture
to
aid
in
the
understanding
of
the
potential
occupational
and
environmental
exposure
to
PFOA
from
telomer­
treated
article
manufacturing
processes.

How
many
samples
will
be
analyzed?

8
TRP
(
9­
May­
03)

Following
the
rationale
developed
for
LOI
Item
1,
the
TRP
is
currently
considering
testing
the
twelve
(
12)
telomer­
based
polymeric
products.
These
12
product
types
are
those
marketed
and
sold
for
use
in
three
major
end­
use
article
categories:
carpets,
textiles,
and
paper.
The
product
types
to
be
tested
are
those
that
the
respective
TRP
member
companies
manufacture
as
actual
items
of
commerce.

How
will
representative
articles
be
selected?

Under
this
LOI
item,
the
same
rationale
is
used
for
selection
of
representative
sales
products
and
treated
articles
as
for
Product
and
Article
Analysis
(
LOI
Item
1).
That
is,
at
the
respective
TRP
member
manufacturing
sites,
representative
telomer­
based
polymeric
product
samples
will
be
collected
and
sealed
immediately,
and
then
shipped
to
the
designated
contractor
for
laboratory
analysis.

Will
the
number
of
articles
analyzed
be
sufficient
to
make
a
judgment
about
the
overall
contribution
of
telomer
treated
articles
to
PFOA
in
the
environment?

The
number
of
articles
chosen
to
be
analyzed
will
provide
important
base
values
for
the
level
of
PFOA
in
the
articles,
and
their
contribution,
if
any,
to
the
PFOA
levels
in
the
environment.
If
the
results
of
these
tests
show
no
significant
level
of
PFOA,
then
it
is
a
reasonable
assumption
that
these
articles
are
contributing
PFOA
to
the
environment.
The
TRP
expects
that
this
initial
set
of
tests
will
indeed
allow
us
to
make
an
initial
judgment
about
the
overall
contribution
from
the
treated
articles.
However,
until
actual
levels
of
PFOA
can
be
quantified
and
until
the
accuracy
and
variability
of
the
method
can
be
established,
no
"
certified"
judgment
can
be
rendered.

What
test
method
will
be
used
to
analyze
the
samples?
(
Will
it
be
the
same
test
method
as
in
item
1?)

Test
methods
to
conduct
these
mill
analyses
have
not
yet
been
developed.
The
TRP
is
working
to
develop
the
appropriate
validated
methods
to
conduct
these
studies.

What
is
the
accuracy
and
precision
of
the
test
method?

The
accuracy
and
precision
of
the
test
method
will
be
determined
once
the
subject
test
methods
are
developed
and
validated.

Will
PFOA
precursors
such
as
free
telomer
alcohols
be
analyzed
for
in
addition
to
PFOA?
If
so,
which
ones?

No.
At
this
time,
our
current
focus
is
to
determine
if
PFOA
is
present
in
telomer­
based
polymeric
products
and
articles
treated
with
those
products.

Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
If
so,
please
provide
a
copy.
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
i.
e.,
to
AR226
or
8(
e)),
please
identify
the
submission.

This
plan
is
under
development
and
will
be
submitted
to
the
Agency
as
soon
as
it
is
available.

9
TRP
(
9­
May­
03)

What
is
the
timing
of
this
work?

March
/
April
2003:
Preliminary
study
design
for
release
estimate
analysis
May
 
July
2003:
Release
estimate
analysis;
develop
release
scenarios
May
 
July
2003:
Method
development
/
demonstration
for
PFOA
determination
in
mill
simulations
August
2003:
Results
expected
from
release
estimate
analysis;
identify
and
solicit
bids
from
potential
contract
labs
to
conduct
mill
simulations
September
 
December
2003:
Conduct
mill
simulations
and
report
results
to
EPA
Biodegradation
Analysis
(
LOI
Item
5,
page
5)

8­
2
Telomer
Alcohol
Method
development
work
has
been
conducted
with
8­
2
Telomer
Alcohol
(
C8
F17
CH2
CH2
OH)
to
be
able
conduct
biodegradation
studies
and
investigate
the
potential
for
generation
of
PFOA
under
biodegradation
study
conditions.
A
preliminary
screening
study
with
cold
test
material
conducted
by
DuPont
used
the
concept
of
OECD
Guideline
for
Testing
of
Chemicals;
Section
3:
Inherent
Biodegradability
(
1992).
This
test
generates
environmental
fate
information
potentially
relevant
to
the
persistence
of
the
test
substance.
The
final
report
from
this
accelerated
biodegra­
daion
study
was
submitted
by
DuPont
to
EPA
on
March
21,
2003
(
DuPont
Report
#
EMSER
15­
03).
A
follow­
on
study
sponsored
by
the
TRP
using
14
C­
labeled
test
material
is
underway.
This
is
a
28­
day
OECD
301D,
Closed­
bottle,
Ready
Biodegradation
study
(
under
Good
Laboratory
Practices)
utilizing
unacclimated
municipal
sludge
with
[
3­
14
C]
8­
2
Telomer
B
Alcohol.
In
addition,
a
study
has
been
initiated
by
the
TRP
to
determine
the
adsorption­
desorption
behavior
of
14
C­
labeled
8­
2
Telomer
B
Alcohol
for
a
range
of
solids
and
sediments.
These
two
studies
will
provide
essential
data
for
design
and
protocol
development
for
long­
term,
higher
tier
studies
on
8­
2
Telomer
B
Alcohol.
The
scope
and
rationale
for
the
8­
2
Telomer
B
Alcohol
Biodegradation
Research
under
the
TRP,
which
was
provided
to
EPA
on
March
31,
2003,
contains
more
details
on
the
completed
and
planned
biodegradation
work.

Telomer­
Based
Polymeric
Products
The
TRP
proposes
to
conduct
further
studies
to
determine
whether
telomer­
based
polymeric
products
might
transform
to
perfluorooctanoic
acid
(
PFOA)
or
its
salts
under
environmentally
relevant
laboratory
study
conditions.

The
telomer­
based
polymeric
products
are
generally
20%
aqueous
dispersions
of
telomer­
containing
polymeric
particles.
The
telomer
functionality
F(
CF2
CF2
)
n
CH2
CH2
­
is
covalently
bound
to
the
polymer
backbone.

This
proposal
considers
both
biotic
and
abiotic
transformation
processes
that
may
be
relevant.
It
is
expected
that
results
from
ongoing
Telomer
Research
Program
(
TRP)
studies
on
8­
2
Telomer
B
Alcohol
(
C8
F17
CH2
CH2
OH)
will
provide
helpful
information
to
enable
this
work
to
be
accomplished,
specifically,
sampling
and
analysis
methods.
However,
as
the
polymeric
products
are
substantially
more
complex,
it
is
possible
that
difficulties
may
be
encountered
in
developing
and
validating
an
analytical
method
or
methods
to
sufficiently
recover
and
thereby
quantitatively
determine
PFOA
in
these
complex
matrices.

10
TRP
(
9­
May­
03)

Significance
/
Expected
Outcome:
This
study
work
will
provide
important
information
regarding
whether
telomer­
based
polymer
products
may
transform
or
break
down
into
PFOA
or
its
salts.

How
many
products
will
be
studied
and
how
will
they
be
selected?

The
TRP
proposes
to
conduct
initial
biodegradation
screening
studies
on
the
12
telomer­
based
polymeric
products
which
are
part
of
the
Product
and
Article
Analysis
studies
(
LOI
Item
1)
previously
submitted
to
EPA.
The
selected
products
represent
the
majority
of
global
product
types
used
for
textile,
carpet
and
paper
treatment.
The
TRP
proposes
to
conduct
studies
on
these
substances
following
a
modified
OECD
302
28­
day
Inherent
Biodegradation
protocol
(
a
draft
outline
of
the
protocol
is
attached
to
the
work
plan).
The
quantitative
determination
of
PFOA
is
the
key
study
endpoint.
Additional
proposed
endpoints
to
be
monitored
include
measurement
of
dissolved
organic
carbon
(
DOC)
or
carbon
dioxide
(
CO2
)
evolution
and
fluoride
(
F­
).
The
OECD
302
inherent
studies
are
proposed
because
the
study
design
would
represent
the
"
most
favorable"
conditions
under
which
biotransformation
may
occur.
The
innoculum
to
be
used
for
the
study
will
be
municipal
sludge.

The
polymers
(
acrylates
and
urethanes),
which
are
the
major
component
of
the
products,
have
molecular
weights
above
1000
ranging
to
well
above
100,000
daltons,
are
non­
polar
and
of
no
 
low
water
solubility.
It
is
widely
reported
in
the
literature
that
polymers
of
this
type
are
not
bioavailable
to
microorganisms
and
would
not
be
expected
to
undergo
transformation.
Should
a
significant
amount
of
PFOA
be
generated
as
a
result
of
biotransformation
in
these
initial
studies
on
the
product
in
its
entirely,
TRP
will
consider
disaggregating
the
polymeric
product
to
explore
and
identify
specific
components
from
which
PFOA
may
originate
Abiotic
Degradation
Three
predominant
abiotic
degradation
pathways
are
expected
for
telomer­
based
polymeric
products:
(
1)
photolytic,
(
2)
thermal
and
(
3)
incineration.
Studies
to
explore
these
potential
pathways
are
already
included
in
the
TRP
Letter
of
Intent.
Photolytic
and
thermal
degradation
of
polymeric
products
and
articles
treated
with
them
is
described
in
LOI
Appendix
4,
Item
2.
Incineration
is
described
in
Appendix
4,
Item
6.
These
studies
will
provide
information
relevant
to
these
abiotic
transformation
processes.
Pending
the
results
of
these
studies,
additional
work
may
be
planned
to
explore
these
pathways
by
other
study
methodologies.

What
are
the
chemical
identities
of
the
products?

The
TRP
member
companies
have
individually
submitted
the
chemical
identity
of
the
polymeric
products
to
be
tested
as
confidential
business
information
to
the
agency.

What
test
method
will
be
used?

8­
2
Telomer
B
Alcohol
Studies:
 
Accelerated
Biodegradation
Test
/
Preliminary
Screening
Study:
Modified
OECD
302
Guidelines
 
Aerobic
Biodegradation:
28­
day
OECD
301D,
Closed­
bottle,
Ready
Biodegradation
study
(
under
Good
Laboratory
Practices)
with
[
3­
14
C]
8­
2
Telomer
B
Alcohol
11
TRP
(
9­
May­
03)

 
Adsorption
/
Desorption
Using
a
Batch
Equilibrium
Method:
Soils
 
OECD
Guideline
106;
Activated
Sludge
Sorption
Isotherm
 
OPPTS
835.1110
Telomer­
Based
Polymeric
Products:
Modified
OECD
302
B:
Zahn­
Wellens/
EMPA
Test
What
is
the
accuracy
and
precision
of
the
test
method?

The
study
test
method,
OECD
302B
is
well
known.
The
specific
study
protocol
was
provided
separately
to
EPA
on
May
9,
2003
for
review
and
comment.
The
analytical
method
for
determination
of
PFOA
has
been
described
in
the
DuPont
report
above.
The
specific
method,
its
accuracy
and
precision
for
the
proposed
studies
will
need
to
be
demonstrated
and
validated
as
part
of
the
study
work.

Will
PFOA
precursors
such
as
free
telomer
alcohols
be
analyzed
for
in
addition
to
PFOA?
If
so,
which
ones?

The
TRP
studies
are
focused
on
identification
and
quantitation
of
PFOA.
The
results
of
these
studies
will
be
reviewed
to
determine
what,
if
any,
additional
study
work
to
pursue.

Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
If
so,
please
provide
a
copy.
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
i.
e.,.
to
AR226
or
8(
e)),
please
identify
the
submission.

A
draft
study
protocol
was
submitted
to
EPA
along
with
the
rationale
for
the
biodegradation
studies
on
telomer­
based
polymeric
products
(
submitted
May
9,
2003).

What
is
the
timing
of
this
work?

May
2003
 
Finalize
study
protocols
June
2003
 
Review
study
rationale
and
protocols
with
EPA
June­
Sept
2003
 
Conduct
studies
Submit
study
reports
as
they
become
available.

Incineration
Analysis
(
LOI
Item
6,
page
5)

The
TRP
is
planning
to
conduct
a
desk
study
on
the
ultimate
fate
and
disposal
routes
(
incineration
versus
landfill)
of
the
telomer­
based
polymeric
products
and
articles
treated
in
the
United
States.
Available
information
will
be
compiled
and
reviewed;
the
results
will
be
provided
to
EPA.
Concurrently,
TRP
will
examine
information
available
on
types
of
incineration
tests
that
may
be
applicable.
An
independent
consultant
will
be
retained
to
review
and
analyze
such
tests.
EPA
may
also
have
some
information
that
is
relevant.

In
addition,
the
TRP
has
identified
and
initiated
discussions
with
a
research
laboratory
known
for
their
capability
to
conduct
studies
to
determine
the
outcome
from
incineration.

Significance
/
Expected
Outcome:
Prior
to
conducting
analysis
of
incineration
methods
and
actual
incineration
tests,
information
is
need
to
determine
if
incineration
is
a
significant
disposal
12
TRP
(
9­
May­
03)

13
route
for
telomer­
based
polymeric
products
and
articles
treated
in
the
United
States.
The
out­
come
of
the
"
Incineration
versus
Landfill
Study"
will
provide
critical
information
on
whether
to
pursue
incineration
tests.

Note:
Most
of
the
questions
posed
by
EPA
in
the
April
30
letter
regarding
incineration
are
not
relevant
to
TRP's
current
research
plans
as
described
in
the
LOI.
EPA's
questions
follow.

How
many
products
and
articles
will
be
analyzed?

How
will
representative
products
and
articles
be
selected?

What
are
the
chemical
identities
of
the
products?

What
test
method
will
be
used
to
analyze
the
samples?

Has
the
test
method
ever
been
validated?

What
is
the
accuracy
and
precision
of
the
test
method?

Will
PFOA
precursors
such
as
free
telomer
alcohols
be
analyzed
for
in
addition
to
PFOA?
If
so,
which
ones?

Do
you
have
a
consolidated
written
description
of
the
procedures
that
will
be
followed
with
this
testing?
If
so,
please
provide
a
copy.
If
these
procedures
have
already
been
identified
in
a
submission
to
the
Agency
(
ie.
to
AR226
or
8(
e)),
please
identify
the
submission.

What
is
the
timing
of
this
work?

May
 
July
2003
 
Compile
information
on
telomer­
based
polymeric
products
and
uses
to
understand
the
ultimate
fate
and
disposal
routes
(
landfill
versus
incineration)
for
telomer­
treated
articles
in
the
United
States.

 
Review
information
on
types
of
incineration
tests
that
may
be
applicable
and
provide
this
information
to
EPA.