U.
S.
Environmental
Protection
Agency
July
8,
2003
Draft
Agenda
Fluoropolymer
Technical
ECA
Workgroup
Meeting
Wednesday,
July
9,
2003
9:
00­
12:
00
PM
Mission
Statement:
The
Fluoropolymer
Workgroup
will
develop
ECA
proposal(
s)
for
data
needs
identified
in
items
2,
7,
8,
9
and
11
of
Table
II
in
the
EPA
Preliminary
Framework
document,
specifically
addressing:
(
a)
the
physical/
chemical
(
p­
chem)
properties
of
the
fluoropolymers;
(
b)
the
presence
of
PFOA
emitted
from
fluoropolymer­
treated
products
and
articles
as
they
age
during
use
for
those
products
and
articles
not
included
in
the
Letter
of
Intent
(
LOI)
commitments;
(
c)
determining
the
incineration
byproducts
of
fluoropolymers
and
fluoropolymer­
treated
articles
and
determining
the
p­
chem,
fate,
and
transport
properties
of
those
byproducts;
and
(
d)
product
stewardship
information.

Meeting
Objective:
Development
meeting
to:
1.
Comment
on
information
received
following
the
previous
workgroup
meeting.
2.
Clarify
the
industry
LOI
and
identify
further
topics
for
ECA
development.
3.
Discuss
and
develop
an
ECA
proposal
for
incineration
testing.
4.
Discuss
additional
ECA
candidate
topics
and
develop
initial
proposals.
5.
Prepare
workgroup
presentation
to
plenary
session
and
select
spokesperson.
6.
Identify
workgroup
next
steps
and
assignments.

Workgroup
Participants:
3M;
Bennett
&
Williams;
CPSC;
EPA;
EWG;
FMG
Order
of
Meeting:
°
Introductions:
Chair,
Phil
Oshida,
Director,
Chemical
Control
Division,
U.
S.
EPA
EPA
Technical
Lead:
Greg
Fritz,
acting
for
John
Blouin,
Economics,
Exposure
&
Technology
Division
°
Review
and
comment
on
information
circulated
after
June
23,
2003
meeting
°
EPA
presentation
comparing
LOI
commitments
with
EPA
data
needs
and
identifying
potential
topics
for
ECA
development
°
Discussion
of
proposed
ECA
for
incineration
testing;
identification
and
discussion
of
additional
candidate
ECA
topics
°
Preparation
of
workgroup
report
to
plenary
session
and
identification
of
spokesperson
°
Identification
of
workgroup
next
steps;
determination
of
workgroup
assignments
PFOA
ECA
Fluoropolymer
Technical
Workgroup
Meeting
July
9,
2003
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ECA
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ECA
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2003
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1
FMG
ECA
Workgroup
Summary
USEPA
Dr.
Greg
Fritz
July
9,
2003
Summary
FMG
LOI
Commitments
°
Product
Stewardship
°
P­
Chem
Properties
(
Handout)

°
Testing
Articles
of
Commerce
 
New
vs
Aged
 
Proposed
15
candidates
°
Incineration
(
not
mentioned)
EPA
Data
Need:
P­
Chem
Fate
°
Data
provided
in
handout
°
Low
VP
and
Sol­
H2O
for
certain
polymers
­
>
1000
MW
and
low
oligomeric
content
°
No
hydrolysis
expected
°
Weathering
/
Exposure
studies
provided
evidence
of
stability
(
prop.
retention)

°
Phototransparency
(
light
stable)
Fate
Issues
to
Address
°
Given
transparency
and
weathering
data:

 
Are
long
term
photolysis
studies
warranted?

 
Are
long
term
soil
sorption
and
biodegradation
tests
warranted
w/
o
usual
P­
Chem
info?

°
Identification
of
degradants
(
tiered)

 
Chem
ID
and
properties
PFOA
Contamination
­­
LOI
°
Both
Dry
and
Liquid
Resin
Testing
°
Emulsion
Polymerization
(
no
APFO)

°
Most
Dry
Resins
are
PFOA
free
°
FMG
Proposed
Selection
Criteria
°
FMG
proposed
Testing
Protocols
°
Aged
Articles
tiered
to
current
results
 
No
PFOA
from
new
products
exonerates
aging
FMG
Selection
Criteria
°
Low
/
High
Heat
Processing
°
Resin
(
solid)
/
Dispersion
°
Consumer
/
Industrial
Application
°
12
Different
Use
Applications
°
PTFE
/
Fluoroelastomer
/
Fluoroplastic
 
missing
chemical
breakout
°
PV
/
Exposure
Potential
EPA
Data
Needs
°
Sampling
Adequacy
/
Product
Coverage
 
4
plus
pages
of
product
information
 
Complete
coverage
based
on
chemical
°
Tiering
Aged
Products
Currently
In
Use
 
Determine
Product
Lifetimes
 
Simultaneous
testing
w/
LOI
plan
°
Adequacy
/
Validation
Methodology
EPA
Proposed
Incineration
ECA
°
Testing
Resins
/
Dispersions
/
Articles
 
Initial
Sample
Use
Article
Plan
 
Unlike
PFOA
contamination:
Incineration
products
should
be
universal
for
FMG
products
and
anticipate
independent
of
sample
 
Simple
endpoint:
Do
high
C
chain
acids
form?

 
Variable
T
range
and
documented
conditions
 
May
contribute
to
monitoring
concerns
July
8,
2003
EPA
ECA
Proposal
for
Fluoropolymer
Incineration
Testing
Rationale
Incineration
testing
of
fluoropolymers
and
fluoropolymer
treated
articles
was
not
included
in
the
FMG
LOI
commitments.
The
degradents
of
perfluorinated
materials
vary
greatly
as
a
function
of
incineration
temperature
and
residence
time.
Thermodynamically,
at
a
temperature
of
about
1200
°
C
a
destruction
efficiency
of
99.99%
for
a
C­
F
chemical
bond
can
be
obtained.
Information
on
the
extent
of
destruction
and
full
characterization
of
the
types
of
degradents
formed
at
lower
incineration
temperatures
is
unknown.
This
is
further
confounded
because,
based
on
US
information,
there
are
three
types
of
incinerators
in
operation
across
the
US:
1)
medical
waste
incinerators
operating
around
650
°
C;
2)
municipal
waste
incinerators
(
static
grate)
operating
between
400­
600
°
C;
and
3)
chemical
(
hazardous
waste)
incinerators
operating
up
to
1300
°
C;
and
it
is
expected
that
the
extent
of
destruction
and
types
of
degradents
will
vary
across
each
incinerator
type.

ECA
Proposal
It
is
proposed
that
incineration
testing
be
conducted
to
meet
the
following
data
needs:
<
Define
by
test,
the
temperature
needed
to
provide
99.99%
destruction
of
each
perfluorinated
test
substance/
material,
both
as
the
manufactured
perfluoro
compound
and
the
article
employing
the
perfluoro
compound.
<
Create
an
incineration
temperature
profile
versus
characterized
degradants
Test
substances:
<
Tier
1:
EPA
recommends,
as
a
starting
point,
that
testing
be
conducted
for
each
of
the
12
fluoropolymer
products
identified
by
FMG.
<
Tier
2:
Depending
on
test
results,
an
additional
representative
number
of
product
formulations
and
articles
in
commerce
may
need
to
be
tested.
EPA
recommends
that
the
formulations
and
articles
be
determined
by
members
of
a
technical
subgroup
on
Incineration
Testing.

Test
Method:
Testing
is
to
be
conducted
using
methods
equivalent
to
those
described
or
reviewed
in
"
Guidelines
for
Determination
of
Poly­
halogenated
Dibenzo­
p­
dioxins
and
Dibenzofurans
in
Commercial
Products"
(
see
40CFR,
section
766.1
through
766.18)
and/
or
the
3M
protocol.

Although
the
average
residence
time
may
vary
across
incinerators,
testing
under
this
ECA
proposal
should
satisfy
a
2
second
residence
time.
Incineration
testing
within
these
three
(
3)
temperature
ranges
will
provide
data
that
is
crucial
in
determining
potential
pathways
into
the
environment
of
perfluoro
compounds
and
their
degradants
which
may
be
precursors
to
PFOA.
July
8,
2003
2
The
laboratory
equipment
needed
to
define
temperatures,
residence
times
and
byproducts
produced
includes
a
high
temperature
tubular
furnace
with
carrier
gas
connected
to
a
gas
chromatograph
followed
by
a
mass
spectrometer.
Note:
a
GC­
GC­
MS
arrangement
will
likely
be
necessary
for
sub­
ppm
data
generation.
Thermogravimetric
analysis
will
be
used
before
initiating
the
laboratory
incineration
testing
to
document
the
low
temperature
(<
500
°
C)
behavior
of
the
test
compounds
(
or
articles)
and
to
verify
gasification
of
material
following
ASTM
E1641,
Decomposition
Kinetics
by
Thermogravimetric
Analysis.

EPA
GLP
Data
Quality
and
Quality
Assurance
Requirements:
All
testing
must
conform
with
EPA
GLP
Data
Quality
and
Quality
Assurance
requirements.

Data
Reporting:
The
final
report
on
each
test
substance
tested
must
include
a
detailed
description
of
the
specific
test
conditions
used,
the
test
data
including
any
associated
calculations,
spectra
and
curves.
Details
of
specific
data
to
be
reported
shall,
at
a
minimum,
include
information
similar
to
those
outlined
under
40
CFR,
section
761.70
for
Incineration.
FMG
Presentation
to
Fluoropolymer
Technical
Workgroup
1
ECA
Framework
Item
1
°
Objective:
Obtain
comprehensive
fluoropolymer
market
information
°
PTFE
example
input
form
°
Input
forms
for
remaining
fluoropolymers
will
be
submitted
by
August
1
°
Each
LOI
company
submits
to
EPA
2002
import
and
production
data
for
each
CAS
and
percentages
for
each
of
the
applications
by
August
15,
2003
°
Data
submitted
will
be
CBI
°
EPA
to
aggregate
and
disseminate
consistent
with
CBI
guidelines
°
Industry
recommendation:
after
submittal
and
EPA
review,

Framework
Item
1
complete
2
TOTAL
Others
Rail
car/
tank
trailers
Oil
Additives
&
Lubricants;
Toners
&
inks;
Clay
Absorbent
Bag
Filters;

Thread
Sealant
Tape
Labware;
Wafer
Carrier
Baskets
Fibrous
Gasketing
Barrier
creams;
cosmetics;
dental
floss
Batteries
Hose
And
Tubing:
Fuel
Lines;
Hydraulic
Hose
And
Tubing;
Control
cables;
Bellows
Heat
Resistant/
Low
Friction
metal
coatings;
equipment/
instruments;
surface
coatings
Cookware
Films;
release
films
office
equipment;

Ordnance
&
Pyrotechnics
Weather­
resistant
fabric
coating;
conveyor
belts
Plastic
Processing
Additives;

Bearing
pads;
expansion
joints;
antifriction
pads
&
bushings
Wire
&
cable
insulation;
nuclear
plant
wire
&
cable;
pacemakers
wire
&
cable
insulation
Membranes
for
apparel
O­
rings
&
shaft
seals;
gaskets
and
packings;
pipes,
vessels
and
linings;
valve,
pump,
and
pipe
fittings
Estimated
%
of
Volume
Application
CONTAINS
CONFIDENTIAL
BUSINESS
INFORMATION
AND
TRADE
SECRETS:

NOT
SUBJECT
TO
DISCLOSURE
UNDER
FREEDOM
OF
INFORMATION
ACT.

DOES
NOT
CONTAIN
NATIONAL
SECURITY
INFORMATION
FLUOROPOLYMER/
FLUOROELASTOMER
PRODUCTION
REPORT
Fluoropolymer
Family:
Polytetrafluoroethylene
(
PTFE)
CASRN:
9002­
84­
0
Reporting
Company:
_______________________
Date:__________________

Year
2002
Production
and
Import
volume
(
Metric
Tons)
_________________

User
Industries:
Aerospace,
Architectural,
Automotive,
Chemical/
Petrochemical,
Commercial
Food
Preparation,

Consumer
Products,
Electronics/
Semiconductor,
Medical/
Pharmaceutical
Applications,
Military,
Misc.,

Commercial
Power
Generation/
Pollution
Control,
Telecommunications
End
Use
Applications
3
ECA
Framework
Item
6
°
Objective:
Presence
of
PFOA
in
fluoropolymer
articles
°
Process
Overview
°
Applications
List
°
Selection
Criteria
°
Quadrant
Diagram
°
Testing
Methodology
4
Polymerization
Isolation/
Drying
Extrusion
/
pelletization
Molding
process
Resin
Manufacturer
Resin
Processor
Tubing/
Hose
Films
Molded
Fittings/
valves
Wire
&
Cable
Insulation
Metal
liners
­

pumps,
pipes,
valves
Fibers
APFO
Monomers
Fluoropolymer
Industry
Overview
Stabilization
Concentration
Formulation/

Coating/
casting
/
process
Sintering/
baking
Un­
sintered
products
Aqueous
Dispersions
Cookware
Industrial
Filter
bags
Coated
parts
Fibrous
gaskets
Clay
absorbents
Dry
melt
resins
Isolation/

Drying
Molding/
sintering/

curing/
post
curing
process
W&
C
insulation
Hose/
Tubing
Pipe
liners
Membranes
O­
rings/
seals
Additives
Dry
­
non
melt
resins/
gums
Molding
unsintered
products
Thread
sealant
tapes
5
TYPICAL
FLUOROPOLYMER
END
USE
APPLICATIONS
User
Industries
End
Use
Application
Examples
Processing
Conditions
Product
Type
Aerospace
Membranes
for
apparel
H
R
O­
rings
&
shaft
seals
H
R
wire
&
cable
insulation
H
R
Architectural
bearing
pads
H
R
expansion
joints
H
R
weather­
resistant
fabric
coating;
H
D
Automotive
(
OEM)
control
cables
H
R
fuel
lines
H
R
gaskets
&
packings
H
R
heat
resistant/
low
friction
metal
coatings
H
D
hydraulic
hose
&
tubing
H
R
O­
rings
&
shaft
seals
H
R
valve,
pump
&
pipe
fittings
H
R
wire
&
cable
insulation
H
R
Chemical/
Petrochemical
barrier
creams
H
R
bellows
H
R
fiberous
gasketing
L
D
heat
resistant/
low
friction
metal
coatings
H
D
labware;
H
R
membranes
for
apparel
H
R
pipes,
vessels
&
linings
H
R
rail
cars/
tank
trailers
H
R
seals,
gaskets
&
packings
H
R
valve,
pump
&
pipe
fittings
H
R
Commercial
Food
Preparation
conveyor
belts
H
D
cookware
H
D
hose
&
tubing
H
R
surface
coatings
H
D
Consumer
Products
bicycle
control
cables
H
R
clay
absorbent
L
D
cookware
H
D
cosmetics;
H
R
dental
floss
H
R
heat
resistance/
low
friction
metal
coatings
H
D
membranes
for
apparel
H
R
oil
additives
&
lubricants
H
R
thread
sealant
tape
L
R
Electronics/
Semiconductor
batteries
H
R
hose
&
tubing
H
R
valve,
pump
&
pipe
linings
H
R
wafer
carrier
baskets
H
R
wire
&
cable
insulation
H
R
6
Selection
Criteria
°
Fluoropolymer
production
process
 
Melt/
Extrusion
­
polymer
is
melted
to
create
finished
polymer
 
Polymer
drying
­
polymer
is
dried
to
create
finished
polymer
 
Liquid
Dispersion
­
finished
polymer
is
an
aqueous
dispersion
°
Consumer
applications
­
applications
where
the
general
public
may
routinely
comes
in
contact
with
articles
containing
a
fluoropolymer
°
Industrial
applications
­
applications
that
are
used
in
an
industrial,

commercial,
or
occupational/
professional
setting
°
High
heat
processing
­
applications
where
the
article
during
manufacture
receives
thermal
exposure
(>
250C
and
5
minutes)
above
where
APFO
is
expected
to
be
driven
off
or
destroyed
°
Low
heat
processing
­
applications
where
the
article
during
manufacture
may
not
receive
such
thermal
exposure
°
Volume/
Exposure
Potential?
­
volume
and
exposure
potential
assessed
to
select
from
potential
applications
°
Supply
­
applications
supplied
by
one
or
more
of
the
four
LOI
signatories
7
Polymerization
Isolation/
Drying
Temp
=
160­
180C
Extrusion
/
pelletization
Temp
=
260­
380C
Molding
process
Resin
Manufacturer
Resin
Processor
Tubing/
Hose
Films
Molded
Fittings/
valves
Wire
&
Cable
Insulation
Metal
liners
­

pumps,
pipes,
valves
Fibers
APFO
Monomers
Fluoropolymer
Industry
Overview
Stabilization
Concentration
Formulation
/

Coating/
casting
/

process
Sintering/
baking
Un­
sintered
products
Aqueous
Dispersions
Cookware
Industrial
Filter
bags
Coated
parts
Fibrous
gaskets
Clay
absorbents
Dry
melt
resins
Isolation/

Drying
Temp
=
150­
230C
Molding/
sintering/

curing/
post
curing
process
W&
C
insulation
Hose/
Tubing
Pipe
liners
Membranes
Additives
O­
rings/
seals
Dry
­
non
melt
resins/
gums
Molding
unsintered
products
Thread
Sealant
Tapes
8
Selection
Criteria
°
Fluoropolymer
production
process
 
Melt/
Extrusion
­
polymer
is
melted
to
create
finished
polymer
 
Polymer
drying
­
polymer
is
dried
to
create
finished
polymer
 
Liquid
Dispersion
­
finished
polymer
is
an
aqueous
dispersion
°
Consumer
applications
­
applications
where
the
general
public
may
routinely
comes
in
contact
with
articles
containing
a
fluoropolymer
°
Industrial
applications
­
applications
that
are
used
in
an
industrial,

commercial,
or
occupational/
professional
setting
°
High
heat
processing
­
applications
where
the
article
during
manufacture
receives
thermal
exposure
(>
250C
and
5
minutes)
above
where
APFO
is
expected
to
be
driven
off
or
destroyed
°
Low
heat
processing
­
applications
where
the
article
during
manufacture
may
not
receive
such
thermal
exposure
°
Volume/
Exposure
Potential?
­
volume
and
exposure
potential
assessed
to
select
from
potential
applications
°
Supply
­
applications
supplied
by
one
or
more
of
the
four
LOI
signatories
9
Polymerization
Isolation/
Drying
Temp
=
160­
180C
Extrusion
/
pelletization
Temp
=
260­
380
Molding
process
Temp
=
260­
380C
Resin
Manufacturer
Resin
Processor
Tubing/
Hose
Films
Molded
Fittings/
valves
Wire
&
Cable
Insulation
Metal
liners
­

pumps,
pipes,
valves
Fibers
APFO
Monomers
Fluoropolymer
Industry
Overview
Stabilization
Concentration
Formulation
/

Coating/
casting
/

process
Sintering/
baking
Temp
=
380C
Un­
sintered
products
Aqueous
Dispersions
Cookware
Industrial
Filter
bags
Coated
parts
Fibrous
gaskets
Clay
absorbents
Dry
melt
resins
Isolation/

Drying
Temp
=
150­
230C
Molding/
sintering/

curing/
post
curing
process
Temp
=
180­
380C
W&
C
insulation
Hose/
Tubing
Pipe
liners
Membranes
O­
rings/
Seals
Additives
Dry
­
non
melt
resins/
gums
Molding
unsintered
Products
Thread
Sealant
Tapes
10
Selection
Criteria
°
Fluoropolymer
production
process
 
Melt/
Extrusion
­
polymer
is
melted
to
create
finished
polymer
 
Polymer
drying
­
polymer
is
dried
to
create
finished
polymer
 
Liquid
Dispersion
­
finished
polymer
is
an
aqueous
dispersion
°
Consumer
applications
­
applications
where
the
general
public
may
routinely
comes
in
contact
with
articles
containing
a
fluoropolymer
°
Industrial
applications
­
applications
that
are
used
in
an
industrial,

commercial,
or
occupational/
professional
setting
°
High
heat
processing
­
applications
where
the
article
during
manufacture
receives
thermal
exposure
(>
250C
and
5
minutes)
above
where
APFO
is
expected
to
be
driven
off
or
destroyed
°
Low
heat
processing
­
applications
where
the
article
during
manufacture
may
not
receive
such
thermal
exposure
°
Volume/
Exposure
Potential?
­
volume
and
exposure
potential
assessed
to
select
from
potential
applications
°
Supply
­
applications
supplied
by
one
or
more
of
the
four
LOI
signatories
11
Polymerization
Isolation/
Drying
Temp
=
160­
180C
Extrusion
/
pelletization
Temp
=
260­
380
Molding
process
Temp
=
260­
380C
Resin
Manufacturer
Resin
Processor
Tubing/
Hose
Films
Molded
Fittings/
valves
Wire
&
Cable
Insulation
Metal
liners
­

pumps,
pipes,
valves
Fibers
APFO
Monomers
Fluoropolymer
Industry
Overview
Stabilization
Concentration
Formulation
/

Coating/
casting
/

process
Sintering/
baking
Temp
=
380C
Un­
sintered
products
Aqueous
Dispersions
Cookware
Industrial
Filter
bags
Coated
parts
Fibrous
gaskets
Clay
absorbents
Dry
melt
resins
Isolation/

Drying
Temp
=
150­
230C
Molding/
sintering/

curing/
post
curing
process
Temp
=
180­
380C
W&
C
insulation
Hose/
Tubing
Pipe
liners
Membranes
O­
rings/
Seals
Additives
Dry
­
non
melt
resins/
gums
Molding
unsintered
Products
Thread
Sealant
Tapes
12
Selection
Criteria
Polymer
Process
Processing
Temperature
Consumer/
Industrial
Volume/
Exposure
Potential?

Representative
Product
Aqueous
Dispersion
High
Heat
Low
Heat
Consumer
Industrial
Consumer
Industrial
Exposure
Volume
Exposure
Exposure
Potential
Potential
Potential
Cookware
Commercial
Food
Preparation
Architectural
Fabrics
Clay
Absorbants
Fibrous
Gaskets
13
Polymerization
Isolation/
Drying
Temp
=
160­
180C
Extrusion
/
pelletization
Temp
=
260­
380
Molding
process
Temp
=
260­
380C
Resin
Manufacturer
Resin
Processor
Tubing/
Hose
Films
Molded
Fittings/
valves
Wire
&
Cable
Insulation
Metal
liners
­

pumps,
pipes,
valves
Fibers
APFO
Monomers
Fluoropolymer
Industry
Overview
Stabilization
Concentration
Formulation
/

Coating/
casting
/

process
Sintering/
baking
Temp
=
380C
Un­
sintered
products
Aqueous
Dispersions
Cookware
Industrial
Filter
bags
Coated
parts
Fibrous
gaskets
Clay
absorbents
Dry
melt
resins
Isolation/

Drying
Temp
=
150­
230C
Molding/
sintering/

curing/
post
curing
process
Temp
=
180­
380C
W&
C
insulation
Hose/
Tubing
Pipe
liners
Membranes
O­
rings/
Seals
Additives
Dry
­
non
melt
resins/
gums
Molding
unsintered
Products
Thread
Sealant
Tapes
14
Selection
Criteria
Polymer
Process
Processing
Temperature
Consumer/
Industrial
Volume/
Exposure
Potential?

Representative
Product
Non­
Melt
Resins/
Gums
High
Heat
Low
Heat
Consumer
Industrial
(
Both)

Exposure
Volume
Exposure
Potential
Potential
Dental
Floss
Fuel
Line
Hose
Thread
Sealant
Tape
15
Polymerization
Isolation/
Drying
Temp
=
160­
180C
Extrusion
/
pelletization
Temp
=
260­
380
Molding
process
Temp
=
260­
380C
Resin
Manufacturer
Resin
Processor
Tubing/
Hose
Films
Molded
Fittings/
valves
Wire
&
Cable
Insulation
Metal
liners
­

pumps,
pipes,
valves
Fibers
APFO
Monomers
Fluoropolymer
Industry
Overview
Stabilization
Concentration
Formulation
/

Coating/
casting
/

process
Sintering/
baking
Temp
=
380C
Un­
sintered
products
Aqueous
Dispersions
Cookware
Industrial
Filter
bags
Coated
parts
Fibrous
gaskets
Clay
absorbents
Dry
melt
resins
Isolation/

Drying
Temp
=
150­
230C
Molding/
sintering/

curing/
post
curing
process
Temp
=
180­
380C
W&
C
insulation
Hose/
Tubing
Pipe
liners
Membranes
O­
rings/
Seals
Additives
Dry
­
non
melt
resins/
gums
Molding
unsintered
Products
Thread
Sealant
Tapes
16
Selection
Criteria
Polymer
Process
Processing
Temperature
Consumer/
Industrial
Volume/
Exposure
Potential?

Representative
Product
Melt/
Extrusion
High
Heat
Low
Heat
(
None)

Consumer
Industrial
(
None)
High
Volume
Plenum
Cable
17
Articles
for
the
Article
Test
Plan
Low
Heat
High
Heat
C
ONS
U
ME
R
¨
Thread
sealant
tape
¨
Membranes
for
Apparel
Dental
Floss
Household
Cookware
Commercial
Food
Processing
I
NDUS
T
RI
AL
¨
Bag
filters
Fibrous
gasketing
¨
Thread
sealant
tape
¨
Hoses
and
Tubing
(
Automotive
Fuel
Lines)

¨
PTFE
Fluoroelastomer
¨
Fluoroplastic
(
melt
processible
or
copolymer)

¨
Wire
&
Cable
Insulation
¨
PTFE
¨
Fluoroelastomer
¨
Fluoroplastic
(
melt
processible
or
copolymer)

O­
rings
/
shaft
seals
¨
PTFE
¨
Fluoroelastomer
¨
Architectural
fabrics
18
Testing
Methodology
°
FDA
Guidance
for
Industry
 
Chemicals,
April
2002
°
Extraction
Solvents
 
Water
for
all
tested
articles
 
FDA
Condition
of
Use
­
B
 
Selected
other
solvents
as
appropriate
(
i.
e.,
corn
oil,

alcohol,
etc.)

°
Analytical
Method
 
LC/
MS/
MS
 
Exygen
Research
Analytical
Laboratory
Method
(
01M­

008­
046
revision
1)
19
ECA
Framework
Item
7
°
Objective:
Determine
if
PFOA
is
emitted
from
fluoropolymer­
containing
articles
as
they
age
during
use
°
Industry
group
believes
the
aged
testing
program
is
an
appropriate
candidate
for
ECA
negotiation
°
Necessary
steps
for
aged
testing
program
development
 
Proposed
test
protocol
(
FDA
Test
 
Guidance
for
Industry
dated
April
2002
for
aged
articles)

 
Review
AOC
test
results
 
Propose
selection
criteria
for
AOC
for
aged
testing
 
Review
with
the
interested
parties
 
Review
overall
program
and
articles
20
ECA
Framework
Item
8
°
Objective:
Determination
of
incineration
byproducts
of
fluoropolymer­
containing
articles
°
The
industry
group
recommends
that
incineration
testing
be
included
in
an
ECA
°
To
facilitate
the
creation
of
an
ECA
for
incineration
testing
the
industry
group
recommends
the
following;

 
Using
the
3M
incineration
protocol
as
a
model,
the
industry
group
will
develop
a
protocol
and
submit
it
for
review
by
the
interested
parties
 
The
interested
parties
will
review
the
protocol
and
submit
questions
 
The
protocol
will
be
finalized
in
a
technical
meeting
to
be
scheduled
21
ECA
Framework
Item
9
°
Objective:
Determination
of
P­
chem
fate
and
transport
properties
of
incineration
products
°
The
industry
group
suggests
that
Framework
Item
9
can
not
be
discussed
until
the
completion
of
incineration
testing
called
for
in
Framework
Item
8
22
ECA
Framework
Item
2
°
Objective:
P­
chem
properties
to
inform
fluoropolymer
fate
testing
°
Industry
submitted
a
document
for
PTFE,
FEP,
and
PFA
polymers
P­
chem
properties
on
June
20
The
industry
group
proposes
the
following
°
Similar
P­
chem
property
documents
will
be
prepared
for
remaining
Fluoropolymers
and
Fluoroelastomers
and
submitted
by
August
1
°
3M
to
submit
APFO
document
by
August
1
°
Based
on
the
data
submitted
for
PTFE,
FEP,
and
PFA,

Framework
Item
2
is
complete
for
those
materials
°
With
the
submittal
of
the
data
for
APFO
and
other
polymers,
and
subsequent
review
by
the
interested
parties,

Item
2
will
be
then
be
evaluated
for
completion
23
ECA
Framework
Item
3
°
Objective:
elucidation
of
degradation
pathways
and
identification
of
degradation
products
°
Based
on
the
data
submitted
for
PTFE,
FEP,
and
PFA
in
Framework
Item
2,
the
industry
group
suggests
that
Item
3
is
not
relevant
to
the
study
of
"
outstanding
PFOA
source
and
exposure
questions."

The
industry
group
proposes
the
following
°
Interested
parties
review
the
data
submitted
in
Item
2
and
the
suggestion
that,
based
on
the
data,
Item
3
is
not
relevant.

°
If
technically
based
questions
can
not
be
adequately
answered
by
technical
professionals,
then
additional
testing
would
be
considered
in
an
ECA.

°
If
it
is
concluded
that
the
industry
suggestion
is
valid,
then
Framework
Item
3
will
be
considered
complete
for
PTFE,
FEP,
and
PFA.

°
The
same
review
process
will
be
followed
for
the
remaining
fluoropolymers
and
fluoroelastomers
when
the
data
is
submitted
for
Framework
Item
2.
24
ECA
Framework
Item
4
°
Objective:
determination
of
p­
chem
fate
and
transport
properties
of
major
degradation
products
°
Based
on
the
data
submitted
for
PTFE,
FEP
and
PFA
in
Framework
Item
2,
the
industry
group
suggests
that
Item
4
is
not
relevant
since
these
polymers
are
stable
and
do
not
degrade
via
normal
degradation
pathways
25
ECA
Framework
Item
4
The
industry
group
proposes
the
following
°
Interested
parties
review
the
data
submitted
in
Item
2
and
the
suggestion
that,
based
on
the
data,
Item
4
is
not
relevant
via
normal
degradation
pathways
°
If
technically
based
questions
can
not
be
adequately
answered
by
technical
professionals,
then
additional
testing
would
be
considered
in
an
ECA
°
The
same
review
process
will
be
followed
for
the
remaining
fluoropolymers
and
fluoroelastomers
when
the
data
is
submitted
for
Framework
Item
3.
