Document ID: EPA-HQ-OPPT-2003-0012-0056
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-05-22T04:00Z

Charles
Auer
Sent
by:
Sharon
Clark
05/
21/
2003
04:
25
PM
To:
Mary
Dominiak/
DC/
USEPA/
US@
EPA
cc:
(
bcc:
Mary
Dominiak/
DC/
USEPA/
US)
Subject:
OPPT­
2003­
0012:
Materials
for
June
6,
2003
Meeting
May
21,
2003
To
Interested
Parties
and
Meeting
Attendees:

Please
find
attached
materials
related
to
the
upcoming
public
meeting,
to
be
held
June
6,
2003,
on
the
enforceable
consent
agreement
(
ECA)
development
process
for
perfluorooctanoic
acid
(
PFOA)
and
fluorinated
telomers.
These
materials
include:
Draft
Meeting
Agenda

Discussion
guide:
Preliminary
Framework
for
ECA
Data
Development
for
PFOA
and
Telomers

Background
materials
on
the
ECA
process
and
expected
outputs

List
of
Interested
Parties

Please
note
that
due
to
the
level
of
interest
expressed
by
the
public
and
interested
parties,
the
meeting
will
begin
one
hour
earlier
(
12:
00
PM)
than
indicated
in
the
Federal
Register
Notice
(
1:
00
PM).
The
meeting
will
take
place
at
EPA
Headquarters
in
Room
1153
of
the
EPA
East
Building,
1201
Constitution
Avenue,
NW,
Washington,
DC
20460.
For
security
purposes,
participants
will
be
required
to
pass
through
a
metal
detector,
pass
their
belongings
through
an
x­
ray
machine,
and
present
a
photo
ID
to
gain
entrance
into
the
EPA
building.
No
audio
or
video
recording
will
be
permitted.

The
objective
of
this
meeting
is
to
initiate
negotiations
to
develop
one
or
more
enforceable
consent
agreements.
These
agreements
will
identify
environmental
fate
and
transport
information,
as
well
as
other
relevant
information
to
better
understand
the
sources
of
PFOA
in
the
environment
and
the
pathways
by
which
human
exposure
to
PFOA
is
occurring.
At
this
initial
meeting,
technical
committees
may
be
formed
to
address
issues
specific
to
individual
ECAs,
and
the
parties
will
establish
the
process
and
schedule(
s)
for
further
negotiation
sessions
and
public
meetings.

A
verbatim
transcript
will
be
taken
at
the
meeting
and
entered
into
the
public
docket,
OPPT­
2003­
0012,
at
www.
epa.
gov/
edocket/.

With
respect
to
the
draft
meeting
agenda,
EPA
is
considering
whether
to
attempt
to
set
aside
time
at
the
beginning
of
the
meeting
to
allow
interested
parties
to
make
brief
opening
statements.
This
has
generally
been
EPA's
practice,
but
EPA
is
concerned
that
time
constraints,
combined
with
the
large
number
of
interested
parties
who
have
registered
for
this
meeting,
may
render
this
infeasible.
If
you
would
be
interested
in
making
a
brief
opening
statement,
please
notify
EPA
in
advance,
and
we
will
make
a
determination
as
to
the
practicality
of
providing
time
for
short
verbal
presentations
based
on
the
level
of
response
to
this
request.
Preferably,
you
could
submit
an
opening
statement
in
written
form
either
at
or
before
the
meeting.
EPA
will
make
available
at
the
meeting
hard
copies
of
written
opening
statements
provided
to
EPA
at
least
two
days
in
advance
of
the
meeting,
and
will
place
all
opening
statements
in
the
docket
along
with
the
transcript
of
the
meeting.

If
you
would
like
to
request
time
to
make
an
opening
statement,
or
if
you
have
questions
concerning
this
meeting
or
any
difficulty
in
opening
the
attached
files,
please
contact
Mary
Dominiak
by
phone
at
202/
564­
8104,
or
by
email
at
dominiak.
mary@
epa.
gov.

Sincerely,

Charles
M.
Auer
/
S/
Director
Office
of
Pollution
Prevention
and
Toxics
Preliminary
ECA
Framework.
fina
ECA_
Process5_
20_
03.
p
Initial
Interested
Parties
List.

6­
6­
2003
Draft
Agenda.
p
Charles
M.
Auer,
Director
Office
of
Pollution
Prevention
&
Toxics
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Ave,
NW
(
7401M)
Washington,
DC
20460
Phone
(
202)
564­
3810
Fax
(
202)
564­
0575
Deliveries:
EPA­
East
Building
1201
Constitution
Avenue,
NW
Room
3166A
(
7401M)
Washington,
DC
20004
PUBLIC
MEETING
Enforceable
Consent
Agreement
Development
for
Perfluorooctanoic
acid
(
PFOA)
and
Fluorinated
Telomers
Location:
Environmental
Protection
Agency
(
EPA),
East
Bldg.
Rm.
1153
1201
Constitution
Ave.,
NW,
Washington,
DC
20460
Date:
Friday,
June
6,
2003;
12:
00
PM
­
5:
00
PM
Draft
Agenda
12:
00
­
12:
30
Introduction
of
Participants
 
Opening
Remarks
and
ECA
Process
(
EPA)
 
Charles
M.
Auer,
Director
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)

12:
30
­
1:
00
Overview
of
EPA
Preliminary
Framework
Document
for
ECA
Data
Development
for
PFOA
and
Telomers
I.
Telomer
Data
Needs
II.
Fluoropolymer
Data
Needs
III.
Rationales
for
Proposed
Fate
Testing
and
Monitoring/
Sampling
1:
00
­
2:
00
General
Discussion
of
Testing
Needs
for
Identifying
Sources
of
PFOA
in
the
Environment
and
Pathways
of
Exposure
2:
00
­
2:
10
Break
2:
10
­
4:
00
Identification
and
Discussion
of
ECA
Opportunities
and
Approaches
I.
ECA
Topics
Amenable
to
Quick
Resolution
II.
Telomer
ECAs
III.
Fluoropolymer
ECAs
IV.
Other
Additional
ECA
Opportunities?

4:
00
­
4:
20
Next
Steps
4:
20
­
4:
50
Public
Comment
(
Open
mike:
maximum
time
3
minutes
per
speaker)

4:
50
­
5:
00
OPPT
Closing
Remarks
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
Preliminary
Framework
for
Enforceable
Consent
Agreement
Data
Development
for
PFOA
and
Telomers
Background
As
indicated
in
the
Agency's
Federal
Register
notice
(
68
FR
18626;
April
16,
2003)
on
perfluorooctanoic
acid
(
PFOA)
and
fluorinated
telomers,
EPA
is
interested
in
developing
enforceable
consent
agreements
(
ECAs)
under
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA)
to
identify
environmental
fate
and
transport
information,
as
well
as
other
relevant
information
to
enhance
understanding
of
the
sources
of
PFOA
in
the
environment
and
the
pathways
by
which
human
exposure
to
PFOA
is
occurring.

EPA
anticipates
that
the
ECA
process
will
focus
on
data
needs
issues
beyond
or
supplemental
to
those
contained
in
the
industry
letters
of
intent
(
LOIs)
(
3M,
OPPT­
2003­
0012­
0007;
Fluoropolymer
Manufacturers
Group
(
FMG),
OPPT­
2003­
0012­
0012;
Telomer
Research
Program
(
TRP),
OPPT­
2003­
0012­
0013;
and
all
three
groups
jointly,
OPPT­
2003­
0012­
0016).
All
documents
referenced
in
this
Framework
with
OPPT­
2003­
0012
designation
numbers
can
be
found
in
the
electronic
docket
on
EPA's
website
at
www.
epa.
gov/
edocket/
by
using
the
"
Quick
Search"
feature
to
locate
the
specific
document
number.

EPA
will
not
pursue
additional
health
effects
testing
of
PFOA
through
this
ECA
process.
At
this
time,
and
for
the
purpose
of
this
ECA
process,
EPA
considers
that
the
existing
database
of
hazard
information,
as
augmented
by
additional
studies
already
underway,
presents
an
adequate
understanding
of
PFOA
toxicity.

Independently
of
this
ECA
process,
EPA
has
nominated
a
number
of
fluorochemicals
for
inclusion
in
the
next
National
Health
and
Nutrition
Examination
Survey
(
NHANES)
conducted
by
the
Centers
for
Disease
Control
and
Prevention
(
CDC).
If
the
CDC
includes
these
chemicals
in
the
NHANES
survey,
the
NHANES
data
would
provide
a
national
baseline
for
current
general
population
exposures
to
these
chemicals
via
human
blood
samples.
If
blood
samples
are
analyzed
for
fluorochemicals
over
time,
this
would
allow
the
tracking
of
trends
to
determine
whether
exposures
are
increasing
or
decreasing
over
time.
Accordingly,
EPA
will
not
pursue
human
biomonitoring
through
these
ECAs,
although
targeted
sampling
might
be
considered
in
the
future
if
warranted
by
data
produced
through
ECAs,
voluntary
activities,
CDC
studies,
or
other
information
available
to
EPA..

EPA
anticipates
that
multiple
ECAs
may
result
from
this
process.
For
example,
separate
ECAs
may
be
negotiated
for
telomer
chemicals
and
products
and
for
fluoropolymer
chemicals
and
products,
where
the
issues
presented
by
these
chemicals
and
products
prove
to
be
different
and
where
test
batteries
differ.
In
addition,
it
may
be
possible
to
come
rapidly
to
agreement
and
closure
on
certain
data
needs
involving
standard
test
protocols
and
screening­
level
data.
In
that
instance,
an
ECA
for
the
generation
of
screening­
level
data
may
be
signed
while
negotiations
continue
on
the
need
for
other
data
to
be
developed
by
more
advanced
and/
or
new
protocols.
For
example,
biodegradation
testing
may
be
an
area
for
which
an
ECA
could
be
developed
rapidly.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
2
Similarly,
ECA
testing
requirements
may
be
tiered,
providing
that
subsequent
testing
in
certain
areas
would
depend
on
the
outcome
of
screening
studies.

All
data
to
be
developed
under
this
ECA
process
will
be
subject
to
the
requirements
of
EPA's
Quality
Assurance
Guidelines
(
EPA
Order
5360./
A2,
May
2000),
which
can
be
found
at
www.
epa.
gov/
quality/.
These
guidelines
may
require
the
preparation
of
a
written
Quality
Assurance
Project
Plan
(
QAPP)
describing
the
project
design,
the
methods
to
be
used,
the
project
organization
and
responsibilities,
and
specific
quality
assurance
and
quality
control
activities
that
will
be
implemented
to
achieve
specified
data
quality
goals
or
requirements.
Information
on
QAPPs
and
other
quality
management
and
quality
assurance
tools
are
available
on
EPA's
website
at
www.
epa.
gov/
quality/
qatools.
html.
In
addition,
all
testing
required
by
a
TSCA
Section
4
ECA
will
be
conducted
in
accordance
with
the
EPA
Good
Laboratory
Practice
Standards
(
GLPS)
found
at
40
CFR
part
792.

TSCA
includes
provisions
which
allow
manufacturers,
processors,
and
distributors
to
designate
data
which
they
believe
are
entitled
to
confidential
treatment,
making
them
exempt
from
public
disclosure,
and
to
submit
those
data
separately
from
information
which
will
be
publicly
accessible
(
15
USC
2613).
EPA's
regulations
regarding
confidential
business
information
(
CBI)
are
found
at
40
CFR
Part
2,
Subpart
B
(
see
also,
5
USC
552).
EPA
anticipates
that
certain
items
referenced
in
this
Preliminary
Framework
Document
may
be
claimed
as
CBI,
possibly
including
specific
chemical
identities,
product
formulations,
and
production
volumes.
No
CBI
information
will
be
discussed
or
disclosed
in
public
meetings
or
documents.
Where
CBI
information
is
involved
in
this
ECA
process,
EPA
will
work
directly
with
the
submitter
to
ensure
both
that
CBI
is
protected
and
that
the
goals
of
this
ECA
process
will
be
met.

Introduction
In
this
document,
EPA
presents
for
discussion
a
preliminary
framework
for
the
development
of
data
that
the
Agency
believes
would
be
appropriate
to
address
the
outstanding
PFOA
source
and
exposure
questions
identified
in
the
Federal
Register
notice.
This
document
is
intended
as
a
discussion
guide
for
the
June
6,
2003
meeting,
not
as
a
predetermined
list
of
information
needs
defining
the
outcome
of
the
ECA
process.

This
document
is
presented
in
two
parts,
accompanied
by
two
appendices.
The
two
document
sections,
Telomer
Data
Needs
and
Fluoropolymer
Data
Needs,
present
brief
identifications
of
overarching
needs,
with
tables
listing
possible
test
substances
and
study
protocols.
Appendix
A,
Rationales
for
Proposed
Fate
Testing
and
Monitoring
and
Sampling
Activities,
provides
more
detailed
explanations
of
and
rationales
for
the
specific
tests
and
protocols
identified
in
the
tables
in
the
first
two
sections.
Appendix
B,
Determination
of
Test
Substances,
provides
examples
and
explanations
of
how
specific
test
substances,
which
are
only
identified
generally
in
the
tables
in
the
Preliminary
Framework
Document,
may
be
determined
during
the
ECA
process.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
3
Telomer
Data
Needs
In
their
LOI
(
OPPT­
2003­
0012­
0013),
the
member
companies
of
the
Telomer
Research
Program
(
TRP)
announced
their
commitment
to
analyze
products
containing
telomer
chemicals
and
articles
treated
with
telomer
products,
including
"
aged"
products
and
"
in
use"
articles,
for
the
presence
of
PFOA;
to
characterize
potential
releases
of
PFOA
from
telomer­
based
product
and
article
manufacture;
to
analyze
possible
biodegradation
of
telomer­
based
polymeric
products;
and
to
evaluate
the
fate
and
disposal
routes
for
telomer­
treated
articles
in
the
United
States.
The
term
"
products"
in
this
context
generally
refers
to
chemical
formulations,
including
fire
fighting
foams
and
either
dry
or
liquid
coatings
for
factory
applications,
while
the
term
"
article"
refers
to
an
item
of
commerce
to
which
a
telomer
product
formulation
has
been
applied,
such
as
carpet
or
textiles.
As
described
in
the
LOI,
the
focus
of
the
TRP
product,
article,
and
manufacturing
analysis
is
on
the
presence
of
PFOA
in
products,
articles,
the
manufacturing
workplace,
and
in
manufacturing
releases
and
waste
streams.

EPA
requested
clarification
of
some
of
the
TRP
LOI
commitments
on
April
30,
2003
(
OPPT­
2003­
0012­
0030).
TRP
responded
on
May
9,
2003.
The
TRP
response
and
attachments
can
be
found
in
the
docket
at
OPPT­
2003­
0012­
0049
through
0054.

Fate,
Biodegradation,
and
Incineration
There
is
some
evidence
to
suggest
that
the
degradation
of
telomers
to
PFOA
in
the
environment
may
be
a
stepwise
process.
To
gain
a
better
understanding
of
possible
pathways,
EPA
believes
that
screening
for
the
presence
of
precursors
to
PFOA
formation,
as
well
as
for
PFOA
itself,
is
appropriate.
Such
precursors
could
include,
for
example,
residual
monomer
telomer
alcohols
present
in
polymeric
products.

The
TRP
LOI
commitments
include
biodegradation
studies
on
various
telomer
alcohols,
telomer
products,
and
telomer­
treated
articles.
These
biodegradation
studies
appear
to
be
screening­
level
studies,
predominantly
involving
28­
day
ready
or
inherent
biodegradation
studies.
The
final
report
for
a
ready
biodegradability
test
of
14C
labeled
8­
2
telomer
B
alcohol
is
expected
May/
June
2003.
Protocols
have
been
submitted
for
inherent
biodegradation
testing
of
telomer
based
polymeric
products
and
polymeric
products.
These
studies
are
expected
to
be
conducted
during
the
second
and
third
quarter
of
2003.
Results
indicating
that
these
substances
undergo
biodegradation
would
trigger
further
fate
testing
on
the
biodegradation
products.
Negative
results
from
these
studies
will
be
evaluated
in
the
context
of
the
study
design
and
test
conditions,
including
test
duration,
to
make
a
determination
as
to
how
widely
the
results
can
be
applied.
One
possible
result
is
that
EPA
may
request
that
the
test
duration
be
extended.
Regardless
of
the
outcome
of
these
tests,
EPA
believes
that
longer
term
biodegradation
studies,
conducted
under
environmentally
realistic
conditions,
may
be
necessary
to
provide
confirmation
that
the
data
from
the
shorter­
term
studies
accurately
characterize
the
true
long­
term
degradation
potential
of
these
chemicals.
For
the
purposes
of
the
ECA,
EPA
will
seek
to
incorporate
these
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
4
LOI
screening­
level
data
results
into
a
more
general
decision
process
for
testing
beyond
the
screening
level.

Many
telomer­
based
products
or
telomer­
treated
articles
may
be
subject
to
disposal
by
incineration,
particularly
in
municipal
incinerators,
which
operate
at
lower
temperatures
than
hazardous
waste
incinerators.
The
strength
of
the
carbon­
fluorine
bond
suggests
that
very
high
heat
would
be
needed
to
break
the
bond
and
destroy
the
fluorinated
compound,
and
that
lowertemperature
incineration
processes
might
instead
release
PFOA
or
PFOA
precursors
into
the
environment.
EPA
considers
it
important
to
develop
an
understanding
of
the
incineration
products
of
telomer
chemicals,
products,
and
treated
articles.

Monitoring
With
respect
to
characterizing
releases
from
telomer­
based
product
and
article
manufacture,
EPA
believes
that
screening­
level
environmental
monitoring
in
the
immediate
vicinity
of
all
telomer
manufacturing
facilities,
as
well
as
a
selection
of
facilities
from
different
industries
that
apply
telomer
products
to
end­
use
articles,
is
appropriate.
In
addition,
it
may
be
useful
to
characterize
releases
attributable
to
dispersive
uses
of
telomer
products
that
are
associated
with
direct
discharges
into
the
environment,
such
as
the
use
of
fire
fighting
foams
which
contain
telomer
chemicals
as
fluorosurfactants.
Accordingly,
EPA
is
suggesting
possible
sampling
and
monitoring
activities
addressing
the
potential
presence
of
PFOA
and
of
PFOA
precursors
in
air,
water,
soils,
sediments,
and
biota
at
telomer
manufacturing
and
use
facilities,
and
at
locations
where
fire
fighting
foams
may
be
discharged
into
the
environment.

Information
concerning
blood
levels
in
workers
may
help
to
identify
and
characterize
the
sources
and
pathways
of
exposure,
and
may
be
contemplated
in
the
future
depending
upon
the
results
of
monitoring
for
PFOA
and
PFOA
precursors
in
the
vicinity
of
telomer
manufacturing
and
use
facilities,
and
upon
other
information
available
to
EPA.
EPA
will
not
pursue
blood
monitoring
as
part
of
this
ECA
process.

Product
Stewardship
One
additional
area
of
information
which
EPA
believes
is
necessary
concerns
an
overall
improved
understanding
of
industry's
product
stewardship
efforts
with
respect
to
the
products
and
issues
for
which
PFOA
is
a
concern.
Accordingly,
EPA
considers
the
reporting
of
specific
product
stewardship
information
as
a
data
need
which
should
be
discussed
during
this
ECA
process.
Product
stewardship
information
may
include,
but
is
not
limited
to,
descriptions
of
worker
training
and
labeling
and
other
hazard
communication
tools,
descriptions
of
guidance
provided
to
downstream
users
of
products
and
articles
(
including,
for
example,
specific
processes
to
be
used
during
factory
applications
of
coatings),
and
steps
to
control
and
reduce
exposures,
releases,
and
wastes.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
5
EPA
has
identified
potential
data
needs
for
telomer
chemicals,
products,
and
treated
articles
in
Table
I.
Some
of
these
needs
appear
to
be
met
in
whole
or
in
part
under
the
TRP
LOI
commitments,
and
are
identified
in
the
following
table
with
an
asterisk
(*).
This
ECA
process
offers
the
opportunity
to
further
refine
and
develop
related
testing
and
approaches
to
address
needs
or
to
generate
data
that
go
beyond
those
expressed
in
the
existing
TRP
LOI
commitments.

EPA
recognizes
that
the
suggested
test
methods
identified
in
the
table
may
need
to
be
modified
in
light
of
the
unique
properties
of
these
fluorinated
chemicals.
EPA
requests
that
available
understanding
of
and
experience
with
these
chemicals
and
their
unique
properties
be
made
available
as
part
of
this
process
to
enable
the
identification
and
selection
of
appropriate
representative
test
substances.

Where
possible,
example
test
substances
or
chemicals
have
been
identified
in
the
table
or
suggested
in
Appendix
B,
but
the
actual
test
substances
will
be
determined
during
this
ECA
process.
Test
substances
should
be
representative
of
products
currently
in
commerce.

In
some
cases,
for
the
purpose
of
the
ECA
process,
telomer­
treated
or
telomer­
containing
products
are
of
interest,
and
general
types
of
products
have
been
identified
for
testing.
In
other
cases,
PFOA
precursors
in
telomer
chemical
products
have
been
identified
as
either
potential
test
substances
or
as
substances
which
should
be
the
subject
of
screening
and
detection
tests.
In
this
latter
case,
a
broad
scan
of
telomer
products,
accompanied
by
appropriate
speciation
and
quantitation,
could
assist
in
identifying
the
appropriate
precursors
for
testing
under
an
ECA.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
6
Table
I.
Telomer
Data
Needs
Item
Data
Need:
Telomers
Test
Substances
Suggested
Test
Methods
1.
*
Comprehensive
telomer
market
information:

CAS
numbers
Chemical
names
Synthetic
sequences
Production/
import
volumes
Uses/
applications
All
telomers
and
polymers
made
from
telomers.
None
required
2.
P­
chem
properties
to
inform
fate
testing.

This
information
should
be
obtained
prior
to
fate
testing
of
representative
test
substances.

Unnecessary
for
certain
polymeric
materials
Examples:

telomer
iodides
telomer
alcohols
telomer
esters
of
(
meth)
acrylates
telomer
sulfonates
The
following,
as
appropriate:

*
Water
solubility
OECD
105
*
Vapor
pressure
OECD
104
*
Soil
and
sludge
adsorption/
desorption
isotherm
OPPTS
835.1220
*
UV/
visible
absorption
OPPTS
830.7050
*
Hydrolysis
as
a
function
of
pH
OPPTS
835.2130
3.
Elucidation
of
degradation
pathways
and
identification
of
degradation
products
Telomer
products
will
be
specified,

and
should
be
individual
representative
test
substances
with
appropriate
chain
lengths
representative
of
desired
product
information,
and
different
classes
of
telomer­
based
polymers
such
as
polyethers,
polyurethanes,
and
polyacrylates
The
choice
of
testing
material
should
also
be
based
on
structure,
production
volume,
use,
and
environmental
exposures.
The
following,
as
appropriate:

*
Inherent
Biodegradability
Zahn­
Wellens/
EMPA
Test
835.3200
*
Activated
sludge
sorption
isotherm
OPPTS
835.1110
Aerobic
and
Anaerobic
Transformations
in
Soil
OECD
307
Aerobic
and
Anaerobic
Transformations
in
Aquatic
Sediment
systems
OECD
308
Direct
Photolysis
in
Water
OPPTS
835.2210
Indirect
Photolysis
Screening
Test
OPPTS
835.5270
*
Determination
of
air/
water
partition
coefficient/
Henry's
Law
Constant
(
method
to
be
determined)

Simulation
test­
Aerobic
Sewage
Treatment
(
Activated
Sludge
Units)
OECD
303A
Anaerobic
biodegradability
of
organic
compounds
in
digested
sludge:
measurement
of
gas
production,

OECD
311
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
7
4.
Determination
of
p­
chem,
fate
and
transport
properties
of
major
degradation
products
Synthesis
and
testing
of
standards
for
known
degradants
(
e.
g.,
Rf­
acetate
and
Rf­
acrylate)
P­
Chem
properties/
Fate/
Transport
in
2
&
3
above
Determination
of
air/
water
partition
coefficient/

Henry's
Law
Constant
(
method
to
be
determined).

UV/
visible
absorption
OPPTS
830.7050.

Direct
Photolysis
in
Water
OPPTS
835.2210.

Indirect
Photolysis
Screening
Test
OPPTS
835.5270.

5.
Determination
of
incineration
byproducts
of
telomers
and
telomer
treated
products
and
articles
Representative
telomers
and
telomer
treated
products
and
articles
(
paper,

textile
and
carpet
products,

firefighting
foams)
from
manufacturers
and
importers
"
Laboratory"
Burn
Test
Protocol:

1.
ASTM
E1641:
Decomposition
Kinetics
by
Thermogravimetry.

2.
Laboratory­
Scale
Thermal
Degradation
via
GC/
MS
yielding
the
temperature
for
99%
destruction
efficiency
@
2.0
second
residence
time
&
excess
oxygen.

6.
Determination
of
p­
chem,
fate
and
transport
properties
of
incineration
byproducts
Representative
telomer
incineration
byproducts
(
direct
release
of
PFAC
/

Rf
acetate)

Potential
olefins
from
incineration
oxidation
/
conversion
to
acids
To
be
determined
based
on
incineration
test
results.

[
half
life
gas
phase
HO.
Reactivity]

7.
*
Presence/
quantification
of
PFOA,
telomer
alcohol
or
other
PFOA
precursors
in
telomer
chemical
products
Representative
telomers
from
manufacturers
and
importers
Draft
Study
Plan
received
from
TRP;
however,
Plan
does
not
contemplate
identifying
PFOA
precursors.

Sampling
and
testing
standards
to
be
determined.

8.
*
Presence/
quantification
of
PFOA,
telomer
alcohol
or
other
PFOA
precursors
in
telomertreated
or
telomer­
containing
products
and
articles
Representative
telomer­
treated
or
telomer­
containing
products
and
articles
(
paper,
textile
and
carpet
products,
fire­
fighting
foams),
from
manufacturers
and
importers
Draft
Study
Plan
received
from
TRP;
however,
Plan
does
not
contemplate
identifying
PFOA
precursors
or
addressing
fire
fighting
foams.

Sampling
and
testing
standards
to
be
determined.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
8
9.
*
Presence
of
PFOA,
telomer
alcohol
or
other
PFOA
precursors
emitted
from
telomer
treated
products
and
articles
as
they
age
during
use
Representative
telomers
and
telomer
treated
products
and
articles
from
manufacturers
and
importers
in
indoor
air
adjacent
to
 
and
dust
from
or
adjacent
to
 
carpet,
textile,
and
paper
products.
Draft
Study
Plan
received
from
TRP;
however,
Plan
does
not
contemplate
identifying
PFOA
precursors
or
performing
air
or
dust
analysis.

Sample
before,
during,
and
after
such
activities
as
chemical
re­
treatment
of
carpet
and
apparel,
carpet
vacuuming,
steam
cleaning,
and
laundry
washing
and
drying
(
apparel).

The
range
of
chemical
emissions
from
these
products
and
articles
can
be
estimated
under
laboratory
conditions
such
as
in
test
chambers
or
test
houses.

10.
Release
and
exposure
assessments
for
PFOA
and
PFOA
precursors
adjacent
to
telomer
manufacturing
and
use
facilities;
also
of
control
areas
Representative
telomers
and
related
compounds
in
air,
stream
and
quiet
surface
waters
(
surface
film
and
subsurface),
groundwater,
sediment,

surface
soil,
and
biota.
Sampling
and
testing
standards
to
be
determined.
3M
(
OPPT­
2003­
0012­
0035)
and
DuPont
(
Exygen)

(
OPPT­
2003­
0012­
0040)
PFOA
methods
may
serve
as
initial
point
for
water,
but
they
lack
differentiation
for
surface
film.
Mabury
(
as
described
in
OPPT­
2003­

0012­
0010)
may
provide
air
starting
point.

11.
Release
and
exposure
assessment
for
PFOA
and
PFOA
precursors
from
use
of
fire­
fighting
foam
Representative
telomers
and
related
compounds
in
soil,
groundwater,

surface
water
runoff,
and
air
during
and
after
fire­
fighting
foam
use
Sampling
and
testing
standards
to
be
determined.
3M
(
OPPT­
2003­
0012­
0035)
and
DuPont
(
Exygen)

(
OPPT­
2003­
0012­
0040)
PFOA
methods
may
serve
as
initial
point
for
water,
but
they
lack
differentiation
for
surface
film.
Mabury
(
as
described
in
OPPT­
2003­

0012­
0010)
may
provide
air
starting
point.

12.
Product
stewardship
information
concerning
telomer
products
and
articles
Telomer
products
and
articles
None
required.

*
Denotes
that
the
TRP
has
committed
to
provide
some,
but
not
necessarily
all,
information
concerning
this
particular
data
need
or
endpoint
for
one
or
more
chemicals.
Analytical
methods
are
to
be
determined,
and
data
quality
requirements
need
to
be
reviewed
to
determine
appropriateness
and
acceptability
in
the
context
of
this
ECA.
To
the
extent
that
chemicals
beyond
those
being
covered
under
the
LOI
are
identified
as
possible
test
candidates,
the
need
for
such
testing
will
be
considered
in
the
context
of
the
ECA
process.

Test
methods
may
be
amended
and
adapted
through
the
ECA
process,
and
where
test
methods
have
not
been
identified,
they
may
be
developed
during
the
ECA
process.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
9
Fluoropolymer
Data
Needs
The
fluoropolymers
of
concern
to
the
Agency
are
those
for
which
PFOA
(
generally
in
the
form
of
ammonium
perfluorooctanoate,
APFO)
is
used
as
a
polymerization
aid.
Information
currently
available
suggests
that
these
fluoropolymers
would
not
break
down
to
form
PFOA
as
a
degradation
product.
The
industry
has
indicated
that
PFOA
is
not
expected
to
be
present
in
fluoropolymer
products
manufactured
using
PFOA
as
a
fluoropolymer
processing
aid,
and
has
proposed
in
their
LOI
(
OPPT­
2003­
0012­
0012)
to
test
products
for
the
presence
of
PFOA.
Such
information
may
be
helpful
in
constructing
an
understanding
of
PFOA's
mass
balance
in
these
processes.
Questions
remain
concerning
potential
releases
of
PFOA
from
the
incineration
of
fluoropolymer
products.
EPA's
concern
is
for
potential
releases
of
PFOA
from
fluoropolymer
and
PFOA
manufacturing
processes,
and
from
any
potential
presence
of
residual
PFOA
in
fluoropolymer
products
or
resulting
from
the
incineration
of
such
products.

EPA
requested
clarification
of
certain
of
3M's
and
FMG's
LOI
commitments
on
April
30,
2003
(
OPPT­
2003­
0012­
0028
and
0029,
respectively).
3M
responded
on
May
7,
2003
(
OPPT­
2003­
0012­
0035),
and
FMG
and
DuPont
responded
on
May
5
and
May
7,
2003
(
OPPT­
2003­
0012­
0036
through
0044).

Fate,
Biodegradation,
and
Incineration
EPA
has
identified
some
questions
with
respect
to
the
potential
for
fluoropolymer
degradation,
and
with
the
fate
and
degradation
of
the
products
of
fluoropolymer
incineration.
Accordingly,
EPA
is
suggesting
certain
physical/
chemical
property,
fate,
and
incineration
testing,
as
shown
on
the
following
table.

Monitoring
With
respect
to
characterizing
releases
from
PFOA
manufacture,
from
fluoropolymer
manufacture,
and
from
the
use
of
fluoropolymer
dispersions
in
treating
articles,
EPA
believes
that
screening­
level
environmental
monitoring
in
the
immediate
vicinity
of
all
PFOA
and
fluoropolymer
manufacturing
facilities,
as
well
as
a
selection
of
facilities
from
different
industries
that
utilize
fluoropolymer
dispersions
to
coat
or
treat
other
manufactured
articles,
are
appropriate.
Accordingly,
EPA
is
suggesting
potential
sampling
and
monitoring
activities
addressing
the
potential
presence
of
PFOA
in
air,
water,
soils,
sediments,
and
biota
at
PFOA
and
fluoropolymer
manufacturing
facilities,
and
at
facilities
utilizing
fluoropolymer
dispersions.
EPA
is
also
suggesting
the
sampling
and
testing
of
fluoropolymer
products
and
fluoropolymer­
treated
articles
to
determine
the
potential
residual
presence
of
PFOA
or
the
release
of
PFOA
during
use
and
aging.

Information
concerning
blood
levels
in
workers
may
further
help
to
identify
and
characterize
the
sources
and
pathways
of
exposure,
and
may
be
contemplated
in
the
future
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
10
depending
upon
the
results
of
monitoring
for
PFOA
in
the
vicinity
of
fluoropolymer
and
PFOA
manufacturing
and
use
facilities,
and
other
information
available
to
EPA.
EPA
will
not
pursue
blood
monitoring
as
part
of
this
ECA
process.

Product
Stewardship
One
additional
area
of
information
which
EPA
believes
is
necessary
concerns
an
overall
improved
understanding
of
industry's
product
stewardship
efforts
with
respect
to
the
products
and
issues
for
which
PFOA
is
a
concern.
Accordingly,
EPA
considers
the
reporting
of
specific
product
stewardship
information
as
a
data
need
which
should
be
discussed
during
this
ECA
process.
Product
stewardship
information
may
include,
but
is
not
limited
to,
descriptions
of
worker
training
and
labeling
and
other
hazard
communication
tools,
descriptions
of
guidance
provided
to
downstream
users
of
products
and
articles
(
including,
for
example,
specific
processes
to
be
used
during
factory
applications
of
coatings),
and
steps
to
control
and
reduce
exposures,
releases,
and
wastes.

EPA
has
identified
potential
data
needs
for
PFOA
and
fluoropolymers
in
Table
II.
Some
of
these
needs
appear
to
be
met
in
whole
or
in
part
under
the
3M
and
FMG
LOIs,
and
are
identified
in
the
following
table
with
an
asterisk
(*).
This
ECA
process
offers
the
opportunity
to
further
refine
and
develop
related
testing
and
approaches
to
address
needs
or
to
generate
data
that
go
beyond
those
expressed
in
the
existing
3M
and
FMG
LOI
commitments.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
11
Table
II.
Fluoropolymer
Data
Needs
Item
Data
Need
or
Issue:
Fluoropolymers
Test
Substances
Suggested
Test
Methods
1.
Comprehensive
fluoropolymer
market
information:

CAS
numbers
Chemical
names
Production/
import
volumes
Uses/
applications
All
fluoropolymers
made
using
PFOA
as
fluoropolymer
polymerization
aid
(
FPA).
None
required.

2.
P­
chem
properties
to
inform
fate
testing
Representative
fluoropolymers
The
following,
as
appropriate:

Soil
adsorption/
desorption
isotherm
OPPTS
835.1220
Hydrolysis
as
a
function
of
pH
OPPTS
835.2130
UV/
visible
absorption
OPPTS
830.7050
3.
Elucidation
of
degradation
pathways
and
identification
of
degradation
products
Representative
fluoropolymers
The
choice
of
testing
material
will
be
targeted
based
on
structure,

production
volume,
uses
and
environmental
exposures.
The
following,
as
appropriate:

Inherent
Biodegradability
Zahn­
Wellens/
EMPA
Test
835.3200
Activated
sludge
sorption
isotherm
OPPTS
835.1110
Aerobic
and
Anaerobic
Transformations
in
Soil
OECD
307
Aerobic
and
Anaerobic
Transformations
in
Aquatic
Sediment
systems
OECD
308
Direct
Photolysis
in
Water
OPPTS
835.2210
Indirect
Photolysis
Screening
Test
OPPTS
835.5270
Determination
of
air/
water
partition
coefficient/
Henry's
Law
Constant
(
method
to
be
determined)

Simulation
test­
Aerobic
Sewage
Treatment
(
Activated
Sludge
Units)
OECD
303A
Anaerobic
biodegradability
of
organic
compounds
in
digested
sludge:
measurement
of
gas
production,
OECD
311
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
12
4.
Determination
of
p­
chem,
fate
and
transport
properties
of
major
degradation
products
To
be
determined
based
on
test
results
P­
Chem
properties/
Fate/
Transport
in
2
&
3
above
Determination
of
air/
water
partition
coefficient/
Henry's
Law
Constant
(
method
to
be
determined)

UV/
visible
absorption
OPPTS
830.7050
Direct
Photolysis
in
Water
OPPTS
835.2210
Indirect
Photolysis
Screening
Test
OPPTS
835.5270
5.
Determination
of
PFOA
FPA
contamination
of
processed
fluoropolymer
(
solid),
including
a
detailed
material
balance
focusing
on
interstage
transfers
and
releases
to
environmental
compartments
Analysis
of
processed
fluoropolymer
products
:
PTFE
homopolymers,

copolymers,
fluoroelastomers.

Validation
of
engineering
models
with
analytical
data.
Documentation
of
PFOA
removal/
destruction
(
asserted
in
AR226­
1000).
To
be
determined
based
on
granular
vs
fine
powder
solids.

The
TRP
proposed
method
for
detecting
PFOA
impurity
in
carpet/
textile/
paper
may
serve
as
a
starting
point
6.
*
Presence
of
PFOA
in
fluoropolymer
and
fluoropolymer
treated
products
and
articles
Representative
fluoropolymers
and
representative
fluoropolymer
treated
products
and
articles
(
paper,
textile
and
carpet
products,
PTFE
cookware,

engine
oil
with
PTFE)
from
manufacturers
and
importers.
Sampling
and
testing
standards
to
be
determined
Stability
of
products
during
melt
processing
or
molding
/
extrusion
procedures.

7.
Presence
of
PFOA
emitted
from
fluoropolymer
treated
products
and
articles
as
they
age
during
use
Representative
fluoropolymers
from
manufacturers
and
importers
in
indoor
air
adjacent
to
 
and
dust
from
or
adjacent
to
 
carpet,
textile,
and
paper.
Sample
before,
during,
and
after
such
activities
as
chemical
re­
treatment
of
carpet
and
apparel,
carpet
vacuuming,
steam
cleaning,
and
laundry
washing
and
drying
(
apparel).

The
range
of
chemical
emissions
from
these
products
and
articles
can
be
estimated
under
laboratory
conditions
such
as
in
test
chambers
or
test
houses.

Sampling
and
testing
standards
to
be
determined.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
13
8.
Determination
of
incineration
byproducts
of
fluoropolymer
and
fluoropolymer
treated
products
and
articles
Representative
fluoropolymers
and
fluoropolymer
treated
products
and
articles
(
paper,
textile
and
carpet
products,
engine
oil
with
PTFE)
from
manufacturers
and
importers.
"
Laboratory"
Burn
Test
Protocol:

1.
ASTM
E1641:
Decomposition
Kinetics
by
Thermogravimetry.

2.
Laboratory­
Scale
Thermal
Degradation
via
GC/
MS
yielding
the
temperature
for
99%
destruction
efficiency
@
2.0
second
residence
time
&
excess
oxygen.

9.
Determination
of
p­
chem,
fate
and
transport
properties
of
incineration
products
Representative
incineration
products
from
8
above.
To
be
determined
based
on
incineration
test
results
10.
*
Release
and
exposure
assessments
adjacent
to
PFOA
and
fluoropolymer
manufacturing
and
use
facilities;
also
of
control
areas
Fluoropolymer
polymerization
aids
(
FPAs)
and
related
compounds
in
air,

stream
and
quiet
surface
waters
(
surface
film
and
subsurface),

groundwater,
sediments,
surface
soil,

and
biota.
Sampling
and
testing
standards
to
be
determined.
3M
(
OPPT­
2003­
0012­
0035)
and
DuPont
(
Exygen)
(
OPPT­

2003­
0012­
0040)
PFOA
methods
in
docket
may
serve
as
initial
point
for
water,
but
they
lack
differentiation
for
surface
film.
Mabury
(
as
described
in
OPPT­
2003­
0012­

0010)
may
provide
air
starting
point.

11.
Product
stewardship
information
concerning
PFOA
and
fluoropolymer
product
and
article
manufacturing,
use,
and
disposal
PFOA
and
fluoropolymer
products
and
articles
None
*
Denotes
that
3M
and/
or
FMG
have
committed
to
provide
some,
but
not
necessarily
all,
information
concerning
this
particular
data
need
or
endpoint
for
one
or
more
chemicals.
Analytical
methods
are
to
be
determined,
and
data
quality
requirements
need
to
be
reviewed
to
determine
appropriateness
and
acceptability
in
the
context
of
this
ECA.
To
the
extent
that
chemicals
beyond
those
being
covered
under
the
LOIs
are
identified
as
possible
test
candidates,
the
need
for
such
testing
will
be
considered
in
the
context
of
the
ECA
process.

Test
methods
may
be
amended
and
adapted
through
the
ECA
process,
and
where
test
methods
have
not
been
identified,
they
may
be
developed
during
the
ECA
process.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
14
APPENDIX
A
Rationales
For
Proposed
Fate
Testing
and
Monitoring
and
Sampling
Activities
This
Appendix
presents
additional
information
explaining
why
certain
testing
may
be
proposed,
and
discussing
proposed
test
standards
and
methodologies.
The
information
in
this
Appendix
applies
to
both
the
telomer
and
fluoropolymer
tables
in
the
Preliminary
Framework
Document.

Testing:
chemical
properties
Objective:
Obtain
fundamental
chemical
property
data
on
subject
telomers
and
fluoropolymers.
Tests:
Water
solubility;
vapor
pressure;
soil
adsorption/
desorption
isotherm;
UV­
Visible
absorption
spectrum;
hydrolysis.
Rationale:
These
data
are
prerequisites
to
and
inform
subsequent
fate
testing.
OECD
guidelines
307,
308,
and
303A
(
respectively
soil;
sediment;
activated
sludge
tests)
all
state
that
information
on
water
solubility,
vapor
pressure,
soil
adsorption/
desorption
isotherm
and
hydrolysis
should
be
available
before
additional
testing
is
done.
Information
on
these
endpoints
is
required
to
ensure
the
correct
design
of
fate
protocols
for
sediment,
soil
and
sludge,
so
that
they
accomplish
their
objectives.
UV­
Visible
absorption
spectrum
is
also
easily
determined
in
the
laboratory
and
indicates
whether
the
test
substance
absorbs
light
in
the
visible
range.
If
it
does,
the
possibility
exists
that
direct
photolysis
may
be
a
significant
fate
process,
and
a
more
definitive
test
to
quantify
this
process
should
then
be
performed.
In
addition,
water
solubility
and
vapor
pressure
together
(
as
the
vapor
pressure/
solubility
ratio)
provide
an
estimate
of
the
Henry's
Law
constant
(
Hc),
which
is
an
important
indicator
of
volatility
from
water.
If
a
test
substance
has
an
estimated
Henry's
Law
constant
within
a
certain
range
(
to
be
decided),
the
substance
should
then
be
subject
to
more
definitive
testing
to
determine
Hc
experimentally.

Testing:
environmental
transformation
Objective:
Identify
the
most
important
environmental
transformation
(
degradation)
processes
for
subject
telomers
and
fluoropolymers.
Elucidate
degradation
pathways
and
identify
and
quantify
major
degradation
products
to
the
extent
possible.
Tests:
Inherent
biodegradability:
Zahn/
Wellens/
EMPA
test
(
OPPTS
835.3200
or
OECD
302B);
Activated
Sludge
Sorption
Isotherm
(
OPPTS
835.1110);
Aerobic
and
anaerobic
transformation
in
aquatic
sediment,
OECD
308;
Aerobic
and
anaerobic
transformation
in
soil,
OECD
307;
Simulation
test­
aerobic
sewage
treatment,
OECD
303(
A:
Activated
sludge
test);
direct
and
indirect
photolysis
in
water;
Anaerobic
biodegradability
of
organic
compounds
in
digested
sludge:
measurement
of
gas
production,
OECD
311.
Because
of
the
unique
properties
of
these
perfluorinated
chemicals,
the
analytical
methods
themselves
may
need
to
be
tailored
to
attain
valid
results.
Rationale:
See
below.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
15
Zahn­
Wellens/
EMPA
test.
OPPTS
835.3200
The
inherent
biodegradability
of
a
test
substance
is
an
important
fundamental
characteristic.
In
concert
with
supplemental
analytical
techniques
the
Zahn­
Wellens
test
can
allow
the
identification
of
important
biodegradation
products
and
pathways
under
conditions
conducive
to
aerobic
biodegradation
in
an
activated
sludge
medium.
The
test
also
gives
an
indication
of
the
potential
for
removal
of
the
test
substance
via
sorption
to
the
activated
sludge
inoculum.

Aerobic
and
anaerobic
transformation
in
aquatic
sediment,
OECD
308.
Test
substances
may
enter
shallow
or
deep
surface
waters
by
a
variety
of
routes,
including
industrial
or
domestic
effluents,
waste
disposal
and
atmospheric
deposition.
The
subject
guideline
is
capable
of
yielding
quantitative
information
on
a
substance's
fate
in
aquatic
sediment
samples
collected
from
the
environment
and
brought
into
the
laboratory
for
study.
The
guideline
is
written
so
as
to
accommodate
a
variety
of
specific
objectives
which
include
multiple
sampling
locations
(
thus
sediments
with
a
variety
of
characteristics);
identification
and
quantification
of
major
degradation
products;
and
specification
of
test
conditions
(
e.
g.
duration,
temperature)
as
appropriate.
Transformation
rates
and
half­
lives
can
also
be
determined
for
subsequent
use
in
environmental
fate
and
exposure
modeling
(
e.
g.
EXAMS
II)
if
that
is
done.

Aerobic
and
anaerobic
transformation
in
soil,
OECD
307.
Test
substances
may
enter
soils
by
a
variety
of
routes,
including
land
application
of
biosolids,
waste
disposal
(
landfilling)
and
atmospheric
deposition.
The
subject
guideline
is
capable
of
yielding
quantitative
information
on
a
substance's
fate
in
soil
samples
collected
from
the
environment
and
brought
into
the
laboratory
for
study.
The
guideline
is
written
so
as
to
accommodate
a
variety
of
specific
objectives
which
include
multiple
sampling
locations
(
thus
soils
with
a
variety
of
characteristics);
identification
and
quantification
of
major
degradation
products;
and
specification
of
test
conditions
(
e.
g.
duration,
temperature,
pressure)
as
appropriate.
Transformation
rates
and
half­
lives
can
also
be
determined
for
subsequent
use
in
environmental
fate
and
exposure
modeling
if
that
is
done.

Simulation
test­
aerobic
sewage
treatment:
OECD
303A,
Activated
sludge
test.
Aqueous
wastes
from
manufacture,
processing
and
use
of
telomers
and
fluoropolymers
may
be
disposed
in
a
variety
of
ways.
Activated
sludge
secondary
treatment
is
the
chief
removal
process
in
publicly
owned
treatment
works
(
POTWs)
and
also
in
many
if
not
most
industrial
wastewater
treatment
systems.
OECD
303A
is
a
simulation
test
for
activated
sludge
treatment
and
as
such,
assuming
proper
conduct
of
the
test,
optimum
selection
of
test
conditions
,
etc.,
can
yield
information
on
removal
that
can
be
used
in
subsequent
modeling
and
exposure
assessment.
Primary
objectives
would
be
to:

(
1)
Identify
the
most
important
transformation
(
degradation)
processes
for
subject
telomers
and
fluoropolymers.
Elucidate
degradation
pathways
and
identify
and
quantify
major
degradation
products
(
if
any)
to
the
extent
possible;
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
16
(
2)
Obtain
measured
values
and
standard
deviations
for
overall
removal
rates
for
the
test
substances
and
any
degradation
products
that
are
also
determined
in
the
studies;

(
3)
Measure
and
quantify
test
substances
and
degradation
products
in
the
three
main
"
waste"
streams
from
such
treatment;
namely
effluent,
waste
sludge
and
aeration
offgases

If
such
testing
yields
negative
results,
defined
as
no
formation
of
biotransformation
products
greater
than
xx
%
relative
to
starting
material,
then
additional
testing
for
this
endpoint
may
be
unnecessary.
An
exception
may
occur
because
any
fate
test
can
only
yield
a
snapshot
of
likely
environmental
processes.
It
is
always
possible
that
the
snapshot
may
turn
out
to
be
unrepresentative
of
some
specific
treatment
plants(
s)
of
interest,
which
might
not
even
be
identified
at
the
time
the
test
is
done.
Positive
results
could
trigger
further
investigation
of
a
specific
removal
process
(
e.
g.,
volatilization,
sorption).

Anaerobic
biodegradability
of
organic
compounds
in
digested
sludge:
measurement
of
gas
production,
OECD
311.
In
wastewater
treatment
a
principal
disposition
of
many
chemical
substances
is
to
partition
to
the
solids
phase.
Chemical
properties
are
a
driving
force
in
this
process,
wherein
partitioning
to
solids
is
favored
for
the
less
water­
soluble
substances.
In
typical
treatment
plants,
especially
those
using
activated
sludge
secondary
treatment,
excess
sludge
is
generated
during
treatment
and
normally
is
sent
to
an
adjacent
anaerobic
digestor
to
reduce
volume
and
organic
load
prior
to
ultimate
disposal.
Conditions
are
not
identical
to
those
of
a
fullscale
digestor,
but
results
of
the
test
should
provide
a
good
indication
of
the
potential
for
degradation
at
full
scale.
Important
test
conditions­­
e.
g.
temperature,
duration,
etc.­­
can
be
selected
so
as
to
mimic
actual
digestors
(
although
the
test
is
not
regarded
as
a
simulation
test).
The
test
is
intended
to
measure
ultimate
anaerobic
degradation
via
total
gas
production
(
a
standard
method),
but
it
can
be
modified
to
incorporate
substance­
specific
analysis.

This
test
can
be
triggered
by
"
significant"
presence
of
test
substances
in
the
sludge,
as
determined
in
the
activated
sludge
simulation
test
(
OECD
303A),
above).
Assuming
optimum
selection
of
test
conditions,
test
duration,
analytical
methods,
etc.,
it
should
be
possible
to
obtain
sufficient
data
to
develop
a
picture
of
the
most
probable
anaerobic
biotransformation
pathway(
s)
and
products
(
if
any).
Quantitative
data
on
removal
of
test
substances
and
removal/
formation
of
degradation
products
(
if
any)
can
be
used
in
subsequent
exposure
modeling,
to
adjust
the
amount
of
the
given
substance
calculated
to
be
sent
later
to
landfill,
spread
on
land
surfaces,
etc.
If
such
testing
yields
negative
results,
defined
as
no
formation
of
biotransformation
products
greater
than
xx
%
relative
to
starting
material,
then
additional
testing
should
be
unnecessary.

Activated
Sludge
Sorption
Isotherm,
OPPTS
835.1110
.
The
sorption
of
chemical
compounds
to
activated
sludge
biomass
in
biological
wastewater
treatment
systems
is
an
important
process
that
affects
the
distribution
of
the
compounds
between
solid,
aqueous,
and
vapor
phases.
If
a
chemical
compound
is
sorbed
to
sludge
biomass,
it
may
be
removed
from
the
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
17
system
along
with
other
solids
by
clarification.
If
a
compound
is
not
sorbed,
it
will
remain
in
the
aqueous
phase
where
it
is
subject
to
removal
via
biodegradation,
chemical
interactions,
and/
or
volatilization.
A
non­
sorbing,
non­
biodegradable,
non­
interacting,
nonvolatile
compound
will
pass
through
a
biological
treatment
system
unaffected.
Information
on
sorption
potential
is
needed
to
assess
the
possibility
for
the
removal
of
chemical
compounds
in
biological
wastewater
treatment
systems.
While
the
focus
of
the
Activated
Sludge
Sorption
Isotherm
test
is
the
measurement
of
sorption
of
the
test
chemical
to
sludge,
it
can
be
modified
to
assess
the
potential
for
desorption
of
the
test
chemical
as
well.
This
modification
would
permit
the
assessment
of
the
potential
for
a
chemical
sorbed
to
sludge
to
be
leached
from
sludge
The
additional
information
would
be
useful
in
examining
the
potential
for
migration
of
the
test
chemical
from
sludge
as
a
result
of
sludge
land
application.

Exposure
Monitoring
and
Modeling
Accurate
estimation
of
total
human
and
environmental
exposures
requires
extensive
knowledge
of
chemical
behavior
(
fate),
routes
and
location
of
exposure,
and
human
activity
patterns
that
lead
to
exposure.
For
a
diverse
set
of
chemicals
in
widespread
use,
a
complex
mix
of
information
must
be
tailored
for
well­
designed
monitoring
tests
or
meaningful
modeling.
Insufficient
information,
poorly
designed
and/
or
incomplete
tests
or
models
will
defeat
the
reasonable
estimation
of
exposures.

Testing:
Monitoring
of
environmental,
general
population
and
consumer
exposure
Chemical
monitoring
in
the
outdoor
environment
is
usually
tailored
to
the
known
or
estimated
behavior
(
fate)
of
the
chemical(
s),
e.
g.,
if
it
is
known
that
a
chemical
partitions
to
water,
monitoring
can
focus
on
the
water
pathway.
Because
neither
all
the
chemicals'
identities
nor
their
fate
are
known,
the
monitoring
suggested
here
must
be
considered
as
subject
to
change
as
more
information
becomes
available.
Given
these
limitations,
the
initial
monitoring
proposal
is
based
on
the
fate
known
for
PFOA,
as
follows:

For
facilities
that
have
manufactured
or
used
the
chemical(
s),
measure
appropriate
chemicals
in
air,
water,
soil,
sediments,
and
biota.
Similar
facility
samplings
should
be
done
at
sites
with
no
expected
sources
of
exposure
 
control
sites.
All
samplings
should
be
designed
to
find
significant
differences
between
sampling
locations
(
control
and
expected),
and
sampling
times,
e.
g.,
before,
during,
and
after
emissions.

Facility
air,
water,
soil,
sediments,
and
biota
samples
should
be
taken
before,
during,
and
after
emissions
to
those
respective
media.
Since
PFOA
may
partition
to
water
surfaces,
both
surface
and
subsurface
water
samples
should
be
gathered,
from
appropriate
stream
and
quiet
water
sites.
Since
PFOA
may
partition
to
airborne
particulates,
surface
soil
samples
should
be
gathered,
from
areas
that
air
monitoring
or
modeling
indicate
are
probable
for
particulate
deposition.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
18
Exposures
to
chemical
emissions
from
products
should
be
estimated
from
appropriate
studies
of
product
use/
activities
in
chamber
or
test
houses.
These
should
include
testing
the
indoor
air
and
dust
on
samples
before,
during,
and
after
such
activities
as
chemical
re­
treatment
of
carpet
and
apparel,
carpet
vacuuming,
steam
cleaning,
and
laundry
washing
and
drying
(
apparel).

Monitoring
Uncertainties
As
in
the
fate
rationale
presented
above,
exposure
monitoring
may
constitute
no
more
than
a
snapshot
of
a
rapidly
changing
situation
and
so
not
be
adequately
representative.
This
is
especially
true
for
media
that
the
chemical
moves
through
but
doesn't
partition
to.
Conversely,
media
that
act
as
sinks
where
the
chemical
can
accumulate
can
obscure
the
source(
s)
and
pathway(
s)
of
exposure,
e.
g.,
PFOA
in
biota.
Repeating
samplings
over
time
may
address
these
concerns,
as
changes
measured
over
time
in
the
pathways
and
in
biota
may
correlate
with
observed
changes
in
environmental
concentrations.
More
certain
correlation
of
pathway
exposure
and
corresponding
environmental
levels
can
be
investigated
with
carefully
planned
radioisotope
studies,
which,
if
in
sufficient
concentration
to
be
detected,
can
be
tracked
from
release
through
exposure.

Testing:
Modeling
of
environmental,
general
population
and
consumer
exposure
An
attempt
to
model
correlations
between
environmental
concentrations
and
human
blood
levels
of
PFOA
was
made
by
DuPont
(
Hinderliter
and
Jepson,
2001).
More
chemical
fate
and
PBPK
information
would
be
needed
to
validate/
improve
this
model.
EPA
is
aware
that
additional
PBPK
studies
in
rats
are
underway
in
Europe.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
19
APPENDIX
B
Determination
of
Test
Substances
This
Appendix
provides
examples
and
explanations
of
how
specific
test
substances,
which
are
only
identified
generally
in
the
tables
in
the
Preliminary
Framework
Document,
may
be
determined
during
the
ECA
process.

Telomers
The
telomer
chemicals
of
greatest
interest
to
the
EPA
are
those
currently
in
commerce.
EPA
is
aware
that
the
specific
identities
of
many
of
the
telomer
chemicals
currently
produced
are
claimed
as
confidential
business
information
(
CBI)
under
the
Toxic
Substances
Control
Act
(
TSCA),
and
are
thus
not
subject
to
public
disclosure.
Accordingly,
EPA
would
expect
that
certain
of
the
identities
of
specific
telomer
test
substances
to
be
used
in
this
ECA
process
would
also
be
claimed
as
CBI,
although
the
test
results
would
be
publicly
available.

For
the
purpose
of
defining
the
types
of
telomer
chemicals
which
would
be
of
interest
to
the
EPA
in
the
context
of
this
ECA
process,
EPA
conducted
a
search
of
the
public
TSCA
Inventory
to
identify
telomer
chemicals
that
reflect
the
scope
of
the
Agency's
interest.
These
chemicals
are
listed
below.
This
list
is
not
comprehensive,
nor
do
the
chemicals
on
this
list
necessarily
represent
chemicals
that
the
Agency
would
propose
as
test
substances
for
this
ECA
process.
This
list
is
offered
to
illustrate
and
provide
examples
of
the
generic
descriptive
terms
used
in
the
tables
in
this
preliminary
framework
document.
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
20
Example
Telomer
Chemicals
and
Polymers
C4­
C18
alcohols,
.
gamma.­.
omega.

CAS
54949­
76­
5:
1­
Butanol,
3,3,4,4,4­
pentafluoro­

CAS
2043­
47­
2:
1­
Hexanol,
3,3,4,4,5,5,6,6,6­
nonafluoro­

CAS
647­
42­
7:
1­
Octanol,
3,3,4,4,5,5,6,6,7,7,8,8,8­
tridecafluoro­

CAS
678­
39­
7:
1­
Decanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10­
heptadecafluoro­

CAS
865­
86­
1:
1­
Dodecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12­
heneicosafluoro­

CAS
39239­
77­
5:
1­
Tetradecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14­
pentacosafluoro­

CAS
60699­
51­
6:
1­
Hexadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16­
nonacosafluoro­

CAS
65104­
67­
8:
1­
Octadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,17,17,18,18,18­
tritriacontafluoro­

C4­
C20
alcohols,
.
gamma.­.
omega.­
perfluoro
(
meth)
acrylates
CAS
52591­
27­
2:
2­
Propenoic
acid,
3,3,4,4,5,5,6,6,6­
nonafluorohexyl
ester
CAS
17527­
29­
6:
2­
Propenoic
acid,
3,3,4,4,5,5,6,6,7,7,8,8,8­
tridecafluorooctyl
ester
CAS
27905­
45­
9:
2­
Propenoic
acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10­
heptadecafluorodecyl
ester
CAS
17741­
60­
5:
2­
Propenoic
acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12­
heneicosafluorododecyl
ester
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
21
CAS
34395­
24­
9:
2­
Propenoic
acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14­
pentacosafluorotetradecyl
ester
CAS
34362­
49­
7:
2­
Propenoic
acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16­
nonacosafluorohexadecyl
ester
CAS
2144­
53­
8:
2­
Propenoic
acid,
2­
methyl­,
3,3,4,4,5,5,6,6,7,7,8,8,8­
tridecafluorooctyl
ester
CAS
2144­
54­
9:
2­
Propenoic
acid,
2­
methyl­,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12­
heneicosafluorododecyl
ester
CAS
6014­
75­
1:
2­
Propenoic
acid,
2­
methyl­,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14­
pentacosafluorotetradecyl
ester
CAS
4980­
53­
4:
2­
Propenoic
acid,
2­
methyl­,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16­
nonacosafluorohexadecyl
ester
CAS
59778­
97­
1:
2­
Propenoic
acid,
2­
methyl­,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,17,17,18,18,18­
tritriacontafluorooctadecy
l
ester
CAS
65104­
66­
7:
2­
Propenoic
acid,
2­
methyl­,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,17,17,18,18,19,19,20,20,20­
heptatriacont
afluoroeicosyl
ester
Other
(
meth)
acrylates
CAS
49859­
70­
3:
2­
Propenoic
acid,
2­[
methyl[(
3,3,4,4,5,5,6,6,7,7,8,8,8­
tridecafluorooctyl)
sulfonyl]
amino]
ethyl
ester
CAS
48077­
95­
8:
2­
Propenoic
acid,
2­[[(
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10­
heptadecafluorodecyl)
sulfonyl]
methylamino]
ethyl
ester
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
22
Phosphates
CAS
148240­
85­
1:
1,3­
Propanediol,
2,2­
bis[[(
g­
w­
perfluoro­
C4­
10­
alkyl)
thio]
methyl]
derivs.,
phosphates,
ammonium
salts
CAS
148240­
87­
3:
1,3­
Propanediol,
2,2­
bis[[(
g­
w­
perfluoro­
C6­
12­
alkyl)
thio]
methyl]
derivs.,
phosphates,
ammonium
salts
CAS
148240­
89­
5:
1,3­
Propanediol,
2,2­
bis[[(
g­
w­
perfluoro­
C10­
20­
alkyl)
thio]
methyl]
derivs.,
phosphates,
ammonium
salts
Other
Class
1/
2
Compounds
CAS
54950­
05­
9:
Butanedioic
acid,
sulfo­,
1,4­
bis(
3,3,4,4,5,5,6,6,7,7,8,8,8­
tridecafluorooctyl)
ester,
sodium
salt
CAS
70983­
60­
7:
1­
Propanaminium,
2­
hydroxy­
N,
N,
N­
trimethyl­,
3­[(
g­
w­
perfluoro­
C6­
20­
alkyl)
thio]
derivs.,
chlorides
CAS
71608­
61­
2:
Pentanoic
acid,
4,4­
bis[(
g­
w­
perfluoro­
C8­
20­
alkyl)
thio]
derivs.,
compds.
with
diethanolamine
CAS
82199­
07­
3:
Carbamic
acid,
[
2­(
sulfothio)
ethyl]­,
C­(
3,3,4,4,5,5,6,6,7,7,8,8,8­
tridecafluorooctyl)
ester,
monosodium
salt
POLYMERS
Polyethers
CAS
68784­
73­
6:
2­
Propenoic
acid,
2­
methyl­,
2­[
methyl[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
amino]
ethyl
esters,
reaction
products
with
polyethylene
glycol
bis(
mercaptoacetate)

CAS
72480­
32­
1:
2­
Propenoic
acid,
2­(
methylamino)
ethyl
ester,
N­[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
derivs.,
reaction
products
with
polyethylene
glycol
bis(
thioglycolate)

CAS
183146­
60­
3:
Oxirane,
methyl­,
polymer
with
oxirane,
mono[
2­
hydroxy­
3­[(
g­
w­
perfluoro­
C8­
20­
alkyl)
thio]
propyl]
ethers
CAS
70983­
59­
4:
Poly(
oxy­
1,2­
ethanediyl),
a­
methyl­
w­
hydroxy­,
2­
hydroxy­
3­[(
g­
w­
perfluoro­
C6­
20­
alkyl)
thio]
propyl
ethers
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
23
CAS
68784­
73­
6:
2­
Propenoic
acid,
2­
methyl­,
2­[
methyl[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
amino]
ethyl
esters,
reaction
products
with
polyethylene
glycol
bis(
mercaptoacetate)

CAS
72480­
32­
1:
2­
Propenoic
acid,
2­(
methylamino)
ethyl
ester,
N­[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
derivs.,
reaction
products
with
polyethylene
glycol
bis(
thioglycolate)

Poly(
meth)
acryate
(
meth)
acrylamide
CAS
70969­
47­
0:
Thiols,
C8­
20,
g­
w­
perfluoro,
telomers
with
acrylamide
CAS
65636­
35­
3:
Ethanaminium,
N,
N­
diethyl­
N­
methyl­
2­[(
2­
methyl­
1­
oxo­
2­
propenyl)
oxy]­,
methyl
sulfate,
polymer
with
2­
ethylhexyl
2­
methyl­
2­
propenoate,

a­
fluoro­
w­[
2­[(
2­
methyl­
1­
oxo­
2­
propenyl)
oxy]
ethyl]
poly(
difluoromethylene),
2­
hydroxyethyl
2­
methyl­
2­
propenoate
and
N­(
hydroxymethyl)­
2­
propenamide
CAS
68239­
43­
0:
2­
Propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester,
polymer
with
a­
fluoro­
w­[
2­[(
2­
methyl­
1­
oxo­
2­
propenyl)
oxy]
ethyl]
poly(
difluoromethylene),
2­
hydroxyethyl
2­
methyl­
2­
propenoate
and
N­(
hydroxymethyl)­
2­
propenamide
CAS
196316­
34­
4:
2­
Propenoic
acid,
2­
methyl­,
2­(
dimethylamino)
ethyl
ester,
polymers
with
g­
w­
perfluoro­
C10­
16­
alkyl
acrylate
and
vinyl
acetate,
acetates
CAS
186397­
57­
9:
2­
Propenoic
acid,
2­
methyl­,
2­(
dimethylamino)
ethyl
ester,
polymers
with
g­
w­
perfluoro­
C10­
16­
alkyl
acrylate
and
vinyl
acetate
CAS
174125­
96­
3:
2­
Propenoic
acid,
2­
methyl­,
2­(
dimethylamino)
ethyl
ester,
polymers
with
d­
w­
perfluoro­
C10­
16­
alkyl
acrylate
and
vinyl
acetate
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
24
CAS
150135­
57­
2:
2­
Propenoic
acid,
2­
methyl­,
2­(
dimethylamino)
ethyl
ester,
polymers
with
Bu
acrylate,

g­
w­
perfluoro­
C8­
14­
alkyl
acrylate
and
polyethylene
glycol
monomethacrylate,
2,2'­
azobis[
2,4­
dimethylpentanenitrile]­
initiate
CAS
68988­
55­
6:
2­
Propenoic
acid,
2­
methyl­,
C7­
18­
alkyl
esters,
polymers
with
2­[
methyl[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
amino]
ethyl
acrylate
CAS
68988­
54­
5:
2­
Propenoic
acid,
2­
methyl­,
C7­
8­
alkyl
esters,
polymers
with
2­[
methyl[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
amino]
ethyl
acrylate
CAS
68988­
53­
4:
2­
Propenoic
acid,
2­
methyl­,
C4­
18­
alkyl
esters,
polymers
with
2­[
methyl[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
amino]
ethyl
acrylate
CAS
68988­
52­
3:
2­
Propenoic
acid,
2­
methyl­,
C4­
8­
alkyl
esters,
polymers
with
2­[
methyl[(
g­
w­
perfluoro­
C8­
14­
alkyl)
sulfonyl]
amino]
ethyl
acrylate
Other
Polymeric
Compounds
CAS
68988­
25­
0:
1,4­
Butanediol,
2,3­
bis[(
g­
w­
perfluoro­
C4­
18­
alkyl)
thio]
derivs.,
polymers
with
1,6­
diisocyanato­
2,2,4(
or
2,4,4)­
trimethylhexane
and
polyethylene­
polypropylene
glycol
bis(
2­
aminomethylethyl)
ether
CAS
68037­
23­
0:
1,4­
Butanediol,
2,3­
bis[(
g­
w­
perfluoro­
C6­
20­
alkyl)
thio]
derivs.,
polymers
with
1,6­
diisocyanatotrimethylhexane
and
2,2'­(
methylimino)
bis[
ethanol]

CAS
135228­
60­
3:
Hexane,
1,6­
diisocyanato­,
homopolymer,
g­
w­
perfluoro­
C6­
20­
alc.­
blocked
CAS
71205­
28­
2:
1,4­
Butanediol,
polymers
with
2,3­
bis[(
g­
w­
perfluoro­
C6­
20­
alkyl)
thio]­
1,4­
butanediol,
C36­
alkylene
diisocyanate
and
1,6­
diisocyanato­
2,2,4(
or
2,4,4)­
trimethylhexane
CAS
68990­
40­
9:
Fatty
acids,
C18­
unsatd.,
dimers,
diisocyanates,
polymers
with
2,3­
bis(
g­
w­
perfluoro­
C4­
18­
alkyl)­
1,4­
butanediol,
1,6­
diisocyanato­
2,2,4(
or
2,4,4)­
trimethylhexane
and
2,2'­(
methylimino)
bis[
ethanol]
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
25
CAS
68037­
22­
9:
2­
Butenedioic
acid
(
2E)­,
bis(
g­
w­
perfluoro­
C4­
20­
alkyl)
esters,
polymers
with
1­(
ethenyloxy)
butanol,

ethylene,
1,4­
hexadiene
and
propene
CAS
170424­
64­
3:
Siloxanes
and
Silicones,
hydroxy
Me,
Me
octyl,
Me
(
g­
w­
perfluoro
C8­
14­
alkyl)
oxy,
ethers
with
polyethylene
glycol
mono­
Me
ether
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
26
Fluoropolymers
The
Fluoropolymer
Manufacturers
Group
(
FMG)
identified
in
their
LOI
a
list
of
fluoropolymers
and
fluoroelastomers
which
may
be
made
with
PFOA,
and
also
identified
monomers
which
are
used
in
fluoropolymer
manufacture.
FMG
subsequently
submitted
a
slightly
revised
list
correcting
typographical
errors
(
OPPT­
2003­
0012­
0034).
EPA
anticipates
that
the
fluoropolymer
and
fluoroelastomer
test
substances
to
be
used
for
the
purposes
of
this
ECA
process
would
be
drawn
from
this
list.

Fluoropolymers
and
Fluoroelastomers
Which
May
Be
Made
With
APFO
Polymer
family
CAS
Number
Monomers
Fluoropolymers
PTFE
9002­
84­
0
TFE
FEP
25067­
11­
2
TFE,
HFP
PFA
26655­
00­
5
TFE,
PMVE
THV
25190­
89­
0
TFE,
HFP,
VDF
ETFE
68258­
85­
5
TFE,
E
HTE
35560­
16­
8
TFE,
HFP,
E
Fluoroelastomers
Copolymers
9011­
17­
0
VDF,
HFP
Terpolymers
25190­
89­
0
TFE,
HFP,
VDF
Base
resistant
elastomers
54675­
89­
7,
27029­
05­
6
TFE,
VDF,
P
TFE,
P
CTFE
elastomers
9010­
75­
7
CTFE,
VFD
Low
temperature
elastomers
TFE,
VDF
U.
S.
EPA
Preliminary
PFOA
ECA
Framework
for
June
6,
2003
Meeting
May
20,
2003
27
Monomers
Used
in
Fluoropolymers
Acronym
Monomer
name
CAS
Number
CTFE
Chlorotrifluoroethylene
79­
38­
9
TFE
Tetrafluoroethylene
116­
14­
3
HFP
Hexafluoropropylene
116­
15­
4
VDF
Vinylidine
fluoride
75­
38­
7
PMVE
Perfluoromethyl
vinyl
ether
1187­
93­
5
PPVE
Perfluoropropyl
vinyl
ether
1623­
05­
8
E
Ethylene
74­
85­
1
P
Propylene
115­
07­
1
U.
S.
EPA
ECA
Process
Background
Document
for
June
6,
2003
Meeting
May
20,
2003
DEVELOPMENT
OF
ENFORCEABLE
CONSENT
AGREEMENTS
(
ECAs)
UNDER
SECTION
4
OF
THE
TOXIC
SUBSTANCES
CONTROL
ACT
(
TSCA)

I.
Intent
The
intent
of
an
ECA
process
under
Section
4
of
TSCA
is
to
develop,
using
a
voluntary
and
public
procedure,
a
legally
enforceable
consent
agreement
to
develop
information
needed
to
provide
an
adequate
understanding
of
relevant
aspects
of
the
impact
of
the
subject
chemical(
s)
on
health
and
the
environment
II.
Objective
The
objective
of
the
ECA
process
is
to
conclude
ECAs
that
will
set
in
place
an
industrysponsored
program
to
develop
the
data
EPA
needs,
usually
through
the
conduct
of
specific
tests.
ECAs
are
an
alternate
vehicle
for
EPA
to
implement
TSCA
Section
4
authority.

III.
Background
Subsequent
to
identifying
testing
needs
for
TSCA­
subject
chemicals,
EPA
may
invite
the
submission
of
proposals
for
conducting
the
needed
testing
via
an
ECA
process.
In
the
case
of
perfluorooctanoic
acid
(
PFOA)
and
fluorinated
telomers,
EPA
determined
that
an
ECA
Process
could
effectively
develop
other
data
needs
for
these
chemicals
that
are
not
covered
under
existing
industry­
sponsored
Letter
of
Intent
(
LOI)
commitments.

The
procedures
for
ECA
negotiations
are
described
at
40
CFR
790.22(
b).
These
procedures
provide
the
basis
for
EPA
to:
a)
enter
into
a
public
process
to
negotiate
testing
programs
to
develop
data
on
chemicals
for
which
data
needs
have
been
identified;
b)
solicit
interested
parties
to
participate
in
the
process;
c)
announce
public
meetings;
and
d)
make
negotiated
products
available
for
public
comment
prior
to
implementation
by
the
Agency.
EPA
may
enter
into
an
ECA
process
for
developing
data
for
its
own
needs
or
in
conjunction
with
other
Federal
Agencies
(
e.
g.,
Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR);
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH);
Occupational
Safety
and
Health
Administration
(
OSHA);
Consumer
Product
Safety
Commission
(
CPSC))
that
express
or
share
the
need
for
data
that
are
critical
for
assessing
chemical
risks
and
for
taking
appropriate
actions
within
their
respective
programs.

It
is
the
goal
of
EPA
to
develop
ECAs
that
would
fulfill
the
identified
data
needs.
While
the
Agency's
objective
of
obtaining
needed
data
could
be
accomplished
by
either
rulemaking
or
establishing
ECAs,
EPA
recognizes
that
the
final
testing
program
performed
by
test
sponsors
may
differ
depending
on
whether
it
is
accomplished
under
a
final
TSCA
Section
4
test
rule
or
via
the
ECA
process.
This
is
because
during
the
course
of
ECA
negotiations,
additional
information
U.
S.
EPA
ECA
Process
Background
Document
for
June
6,
2003
Meeting
May
20,
2003
2
may
be
brought
forward
that
could
cause
the
Agency
to
reevaluate
the
nature
of
the
testing
requirements
that
need
to
be
met.
ECAs
provide
greater
flexibility
for
the
Agency
to
pursue
state­
of­
the­
science
testing
programs
developed
through
iterative
scientist­
to­
scientist
discussions
in
developing
the
ECA.
The
resultant
testing
programs
benefit
EPA
and
the
public
by
providing
reliable
test
data
relevant
to
the
Agency's
data
needs
for
developing
scientifically
defensible
environmental
policies.

IV.
ECA
Process
for
Developing
ECA(
s)
for
Perfluorooctanoic
Acid
and
Fluorinated
Telomers
Although
the
ECA
process
may
vary
slightly
from
one
negotiation
to
another
depending
on
the
issues
under
discussion
and
the
need
for
technical
oversight,
there
are
six
(
6)
overarching
steps
in
the
development
of
an
ECA.

Step
1:
EPA
identifies
data
needs
and
is
receptive
to
obtaining
these
data
via
an
ECA
process.

Step
2:
EPA
initiates
a
notice
in
the
Federal
Register
explaining
the
nature
of
the
topic(
s)
and
focus
of
the
ECA
discussions;
solicits
"
interested
parties"
to
participate
in
discussions
to
develop
an
ECA(
s);
and
announces
the
date,
time,
and
location
for
a
public
meeting.

Step
3
A
public
meeting
is
held
to
identify
the
topics
to
include
for
ECA(
s)
development,
to
establish
the
structure
for
discussions
to
develop
ECA(
s)
for
the
topics
identified,
and
to
establish
a
reasonable
schedule
to
reach
agreement
in
principle
for
the
ECA(
s).

Step
4
After
reaching
agreement
in
principle
for
the
ECA(
s),
EPA,
potential
test
sponsors,
and
interested
parties
enter
into
"
Technical
Discussions"
to
develop
the
details
of
an
acceptable
testing
program
to
meet
EPA's
data
needs.

Step
5
The
acceptable
testing
program
is
incorporated
into
a
draft
ECA(
s).
The
draft
ECA
is
then
distributed
to
interested
parties
for
comment.

Step
6
EPA
considers
comments
and
finalizes
the
ECA,
which
is
announced
in
the
Federal
Register.
The
Federal
Register
notice
establishes
the
schedule
for
testing
and
data
reporting.
U.
S.
EPA
ECA
Process
Background
Document
for
June
6,
2003
Meeting
May
20,
2003
3
V.
Identification
of
Interested
Parties
It
is
essential
for
all
interested
parties
to
recognize
their
responsibilities
in
the
ECA
development
process.
EPA
solicits
interested
parties
to
monitor
or
participate
in
testing
negotiations
on
all
ECAs.
To
be
designated
an
"
interested
party"
for
an
ECA,
one
must
respond
in
writing
to
EPA's
solicitations
in
the
Federal
Register.
The
address
for
this
is
specified
in
the
Federal
Register
solicitation
document.
Individuals
and
groups
who
respond
appropriately
to
the
Federal
Register
solicitation
will
have
the
status
of
interested
parties.
Interested
parties
do
not
incur
any
obligations
by
being
so
designated.
EPA
will
not
reimburse
costs
incurred
by
non­
EPA
participants
in
this
ECA
negotiation
process.
The
official
notice
soliciting
for
interested
parties
to
participate
in
the
development
of
ECA(
s)
for
perfluorooctanoic
acid
(
PFOA)
and
fluorinated
telomers
was
published
in
the
Federal
Register
of
April
16,
2003
(
68
FR18626).

VI.
Public
Participation
in
Negotiations
The
procedural
rule
for
ECAs
(
40
CFR
Part
790)
contains
provisions
to
ensure
that
the
views
of
interested
parties
are
taken
into
account
during
the
ECA
process.
The
public
is
provided
with
an
opportunity
to
comment
on
and
participate
in
the
development
of
ECAs.

All
negotiation
meetings
for
the
development
of
ECAs
will
be
open
to
the
public
and
a
report
on
each
meeting
will
be
prepared
by
EPA
and
placed
in
the
public
docket.
The
Agency
will
advise
interested
parties
of
meeting
dates
and
make
available
meeting
minutes,
testing
proposals,
background
documents,
and
other
materials
exchanged
at
or
prepared
for
the
negotiation
meetings.
Where
tentative
agreement
is
reached
on
an
acceptable
testing
program
("
agreement
in
principle"),
a
draft
ECA
will
be
made
available
for
comment
by
interested
parties
and,
if
necessary,
EPA
will
hold
a
public
meeting
to
discuss
any
comments
that
have
been
received
and
determine
whether
revisions
to
the
draft
ECA
are
appropriate.

VII.
ECA
Negotiation
Outcomes
ECA
negotiations
will
be
conducted
in
one
or
more
meetings
open
to
the
public.
The
negotiation
time
schedule
will
be
established
at
the
first
negotiation
meeting.
It
is
EPA's
goal
that
negotiations
not
last
longer
than
4
months.
ECAs
will
only
be
concluded
where
an
agreement
can
be
obtained
which
is
satisfactory
to
the
Agency,
to
manufacturers
or
processors
who
are
potential
test
sponsors,
and
to
other
interested
parties,
concerning
the
need
for
and
scope
of
testing.
If
an
ECA
is
not
established
in
principle
within
this
time
frame
and
EPA
does
not
choose
to
extend
the
negotiation
time
period,
negotiations
will
be
terminated.
In
the
absence
of
an
ECA,
EPA
reserves
the
right
to
proceed
with
rulemaking
under
section
4
of
TSCA.
Furthermore,
if
the
testing
from
the
ECA
does
not
meet
the
Agency's
needs,
EPA
reserves
the
right
to
enter
into
rulemaking
to
obtain
the
needed
data.
U.
S.
EPA
ECA
Process
Background
Document
for
June
6,
2003
Meeting
May
20,
2003
4
The
Agency
will
not
enter
into
an
ECA
if
either:
1)
EPA
and
affected
manufacturers
or
processors
cannot
reach
an
agreement
on
the
provisions
of
the
ECA;
or
2)
The
draft
ECA
is
considered
inadequate
by
other
interested
parties
who
have
submitted
timely
written
objections
to
the
draft
ECA.

EPA
may
reject
these
objections
if
the
Agency
concludes
either
that:
1)
They
are
not
made
in
good
faith;
2)
They
are
untimely;
3)
They
are
not
related
to
the
adequacy
of
the
proposed
testing
program
or
other
features
of
the
agreement
that
may
affect
EPA's
ability
to
fulfill
the
goals
and
purposes
of
TSCA;
or
4)
They
are
not
accompanied
by
a
specific
explanation
of
the
grounds
on
which
the
draft
agreement
is
considered
objectionable.

EPA
will
prepare
an
explanation
of
the
basis
for
each
ECA
developed.
The
explanatory
document
will
summarize
the
final
agreement
(
including
the
required
testing),
explain
the
objectives
of
the
testing,
and
outline
the
chemical's
use
and
exposure
characteristics.
The
document,
which
also
announces
the
public
availability
of
the
ECA,
will
be
published
in
the
Federal
Register
and
the
FR
publication
date
will
establish
the
effective
date
for
the
ECA,
which
is
the
official
starting
date
for
the
ECA
Testing
Program.
U.
S.
EPA
ECA
Process
Background
Document
for
June
6,
2003
Meeting
May
20,
2003
5
OUTLINE
FOR
AN
ENFORCEABLE
CONSENT
AGREEMENT
Docket
No.
OPPT
­
2003­????

TABLE
OF
CONTENTS
I.
Introduction
II.
Chemical
Subject
to
the
ECA
III.
Obligation
of
Companies
and
Role
of
the
Test
Sponsor(
s)
IV.
Purpose
of
the
Testing
Program
V.
Scope
of
the
Testing
Program
VI.
Description
of
the
Testing
Program
VII.
Standards
for
Conducting
Testing
VIII.
Submission
of
Study
Plans
IX.
Modifications
to
the
Enforceable
Consent
Agreement
X.
Failure
to
Comply
with
the
Enforceable
Consent
Agreement
XI.
EPA
Monitoring
of
Enforceable
Consent
Agreement
Testing
XII.
Submission
of
Data
XIII.
Publication
and
Disclosure
of
Test
Results
XIV.
Confidentiality
of
Information
XV.
Responsibilities
of
the
Companies
XVI.
Severability
of
Enforceable
Consent
Agreement
Provisions
XVII.
Final
Agency
Action
XVIII.
Public
Record
XIX.
Effectiveness
XX.
Rights
of
the
Companies
XXI.
Identity
of
the
Companies
XXII.
Signatures
TABLE
1:
Required
Testing,
Test
Standards,
Reporting
and
Other
Requirements
APPENDICES
A.
Flow
Chart
of
Testing
Program
B.
Guidelines
with
Annotations
as
Appropriate:
(
for
each
test)
C.
Other
(
as
needed)
U.
S.
EPA
Initial
"
Interested
Parties"
List
for
June
6,
2003
Meeting
May
20,
2003
List
of
"
Interested
Parties"
for
PFOA
and
Telomer
ECA
Negotiations
As
of
this
date,
the
following
groups
and/
or
individuals
have
requested
status
as
"
interested
parties"
for
the
purpose
of
monitoring
or
participating
in
ECA
negotiations
on
PFOA
and
fluorinated
telomers.
Please
be
advised
that,
due
to
security
delays
in
the
processing
of
mail
to
Federal
facilities,
additional
"
interested
party"
registrations
may
be
received
between
this
date
and
the
June
6,
2003
meeting.
Updated
lists
will
be
provided
as
needed
before
the
meeting.
Additional
parties
may
attend
as
observers
without
providing
prior
notice
to
the
Agency.

3M
Advanced
Polymer,
Inc.
AGA
Chemicals
American
Council
on
Science
and
Health
American
Chemistry
Council
American
Fiber
Manufacturers
Association,
Inc.
Asahi
Glass
Co.,
Ltd.
Asahi
Glass
Fluoropolymers
USA,
Inc.
ATOFINA
Chemicals,
Inc.
Bennett
&
Williams
(
Environmental
Consultants)
Chamber
of
Commerce
of
the
Mid­
Ohio
Valley
Ciba
Specialty
Chemicals
Corporation
Clariant
GmbH
Daikin
America
Department
of
the
Navy
DuPont
DuPont
Textiles
and
Interiors,
Inc.
Dyneon
Fire
Fighting
Foam
Coalition
Hughes
Associates,
Inc.
International
Imaging
Association
Little
Hocking
Water
Association,
Inc.
Miteni
S.
p.
A.
Mitsubishi
International
Corporation
Ohio
Environmental
Protection
Agency
Ohio
River
Valley
Water
Sanitation
Commission
OMNOVA
Solutions
Parkersburg­
Wood
County
Area
Development
Corporation
Rich
Purdy
Regenerative
Products
Solvay
Solexis,
Inc.
Society
of
the
Plastics
Industry/
Fluoropolymer
Manufacturers
Group
Telomer
Research
Program
The
Carpet
and
Rug
Institute
The
Center
for
Regulatory
Effectiveness
Tuppers
Plains­
Chester
Water
District
United
Bank,
West
Virginia
University
of
Pennsylvania
Medical
Center
W.
L.
Gore
&
Associates,
Inc.
Walki
Wisa
Ltd.
West
Virginia
Class
Action
Plaintiffs