Document ID: EPA-HQ-OPPT-2003-0012-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-04T05:00Z

4
The
Plastics
Indtistry
Ic
I(
Ic
Associd
lion
Donald
K.
Duncan
President
March
14,
2003
The
Honorable
Stephen
L.
Johnson
Assistant
Administrator
The
United
States
Environmental
Protection
Agency,
Headquarters
Office
of
Prevention,
Pesticides
and
Toxic
Substances
1200
Pennsylvania
Avenue
Room
7101M
Washington,
DC
20460
Dear
Mr.
Johnson:

On
behalf
of
the
Asahi
Glass
Fluoropolymers
USA,
Inc.;
Daikin
America,
Inc.;
Dyneon
LLC;
and
E.
I.
du
Pont
de
Nemours
and
Company,
we
are
transmitting
a
Letter
of
Intent
describing
the
initiatives
that
these
companies
have
taken
to
assist
EPA
in
its
assessment
of
perfluorooctanoic
acid
and
its
salts.
This
Letter
describes
in
some
detail
the
activities
underway
to
develop
information
and
data
needed
to
assure
the
continued
safe
use
of
ammonium
perfluorooctanoate
in
the
manufacture,
processing,
and
use
of
fluoropolymers
If
you
have
any
questions
about
the
Letter
of
Intent,
please
contact
Lynne
R.
Harris,
of
The
Society
of
the
Plastics
Industry,
Inc.
(
SPI)
at
202­
974­
5233.

Enclosure
cc:
Charles
M.
Auer
Margaret
N.
Schneider
The
Society
of
the
P~
asticslndus&
y,
tnc.
1801
K
Street,
NW,
Suite
600K
Washington,
DC
20006­
1
301
tel
202.974.5222
°
fax
202.293.0309
dduncan@
socpias.
org
http://
www.
plasticsindustry.
org
Res
ctfu
fltm:,

Don
Duncan
March
14,
2003
Regular
Mail
The
Honorable
Stephen
L.
Johnson
Assistant
Administrator
The
United
States
Environmental
Protection
Agency,
Headquarters
Office
of
Prevention,
Pesticides
and
Toxic
Substances
1200
Pennsylvania
Avenue
Room
7101M
Washington,
DC
20460
Re:
Voluntary
Actions
to
Evaluate
and
Control
Emissions
of
Ammonium
Perfluorooctanoate
(
APFO)

Dear
Mr.
Johnson:

Asahi
Glass
Fluoropolymers
USA,
Inc.;
Daikin
America,
Inc.
(
Daikin);
E.
I.
du
Pont
de
Nemours
and
Company
(
du
Pont),
and
Dyneon
LLC
(
Dyneon)
(
the
"
APFO
Users")
each
use
ammonium
perfluorooctanoate
(
APFO)'
to
produce
fluoropolymers
and
fluoroelastomers
in
the
U.
S.
Fluoropolymers
are
plastic
products
while
fluoroelastomers
are
rubber­
like
products,
both
ofwhich
provide
highly
desirable
and
unique
properties
that
make
the
end­
use
products
created
from
them
useful.
All
ofthese
companies
are
members
of
The
Society
of
the
Plastics
Industry,
Inc.
(
SPI)
Fluoropolymers
Manufacturers
Group
(
FMG)
and
its
Fluoropolymers
Division
(
FPD).
Together,
they
and/
or
their
parent
companies
represent,
both
globally
and
in
the
U.
S.,
most
of
known
use
ofAPFO
for
production
offluoropolymers.

APFO
is
essential
in
making
certain
fluoropolymers,­
2
which,
in
turn,
are
used
in
many
high­
performance
applications
in
critical
industries
such
as
defense,
aerospace,
semiconductors,
telecommunications,
and
pollution
control.
A
list
ofcommercial
fluoropolymers
is
provided
in
Addendum
Ito
this
document.
Many
grades
of
these
fluoropolymers
can
be
made
only
with
APFO.

The
APFO
Users
share
the
goal
of
the
U.
S.
Environmental
Protection
Agency
(
EPA)
to
understand
and
assess
the
toxicity
ofand
exposures
to
the
APFO
usedby
the
fluoropolymer
industry,
and
to
safeguard
human
health
and
the
environment.
To
that
end,
the
APFO
Users
have
made
specific
commitments
to
provide
additional
information
and
research
to
EPA.
These
The
APFO
Users
use
a
commercially
available
form
ofthe
compound,
technically
known
as
octanoic
acid,
pentadecafluoro­,
ammonium
salt,
CAS
3825­
26­
1.

For
purposes
of
this
letter,
we
will
use
fluoropolymers
to
include
fluoroelastomers,
unless
there
is
a
distinction
that
needs
to
be
made.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
2
of
15
commitments
are:
(
1)
to
reduce
emissions
of
APFO
from
fluoropolymer
and
APFO
manufacturing
facilities;
(
2)
to
conduct
studies
on
both
finished
resins
and
finished
products
made
from
these
resins
to
determine
if
any
exposure
to
the
general
population
can
be
related
to
the
fluoropolymer
industry;
(
3)
to
conduct
studies
on
emissions
from
fluoropolymer
processing
facilities
to
determine
the
level
ofcurrent
emissions;
and
(
4)
to
develop
additional
toxicological
data
on
APFO.

This
Letter
of
Intent
includes
timetables
for
completion
of
various
studies
and
research,
including
additional
studies
on
the
toxicity
and
environmental
fate
ofthe
substance.
The
timetables
are
the
best
estimates
available
at
this
time.
The
APFO
Users
will
promptly
provide
EPA
with
the
information
as
it
is
developed
so
that
it
can
be
made
available
to
the
public
generally.

Addendum
II
describes
the
history
ofAPFO
use
in
the
fluoropolymer
industry,
the
reasons
for
the
recent
interest
in
APFO,
and
the
extensive
activities
that
the
APFO
Users
in
the
industry
have
completed,
and
continue
to
conduct,
to
protect
human
health
and
the
environment
while
society
retains
the
substantial
benefits
of
fluoropolymers.

Current
Activities
of
Fluoropolymer
Manufacturers
The
APFO
Users
believe
that
fluoropolymers
and
products
made
from
them
are
safe
for
their
intended
use.
Nevertheless,
the
companies
are
examining
the
use
ofAPFO
more
closely.
Initially,
the
APFO
Users,
in
conjunction
with
the
FMG,
determined
that
they
needed
to
find
out
how
much
APFO
was
used
and
how
much
was
emitted
to
the
environment,
as
well
as
to
reexamine
work
practices
in
their
own
plants.
Thus,
the
FMG
prepared
a
global
materials
balance
including
APPO
used
in
manufacturing
fluoropolymers.

The
information
developed
from
the
materials
balance
was
provided
to
EPA
in
2001;
it
was
updated
in
2002,
and
will
be
revised
in
the
future
as
described
below.
The
global
materials
balance
was
and
is
based
on
the
best
available
evidence
that
the
companies
have
regarding
the
use
ofAPFO
in
making
fluoropolymers
and
the
fate
ofthese
substances
in
the
fluoropolymer
industry.

Based
on
these
estimates
and
the
method
used,
the
companies
have
accounted
for
essentially
all
the
APFO
used
in
the
fluoropolymer
manufacturing
industry.

As
responsible
manufacturers,
the
APFO
Users
are
committed
to
reducing
APFO
emissions.
Based
on
that
global
materials
balance,
and
as
described
below,
FMG
members
have
voluntarily
begun
to
modify
their
processes
to
reduce
AFPO
emissions,
on
a
global,
individual
company­
wide
basis,
by
a
minimum
of50%
for
calendar
year
2006.
This
reduction
will
be
compared
to
baseline
data
submitted
to
EPA
in
September
2002.
This
initial
commitment
was
based
on
the
best
information
available
to
the
companies
at
the
time
of
the
decision
and
what
the
companies
believed
could
be
achieved,
even
with
some
difficulty,
given
the
available
technology,
the
characteristics
and
uses
of
the
surfactants
and
the
nature
ofprocesses
involved.
The
Honorable
Stephen
L.
Johnson
March
14,2003
Page
3
oflS
Using
data
collected
from
the
materials
balance
and
such
environmental
monitoring
and
other
studies
as
they
become
available,
the
companies
will
continue
to
use
appropriate
criteria,
including
such
standards,
limits
or
parameters
as
the
West
Virginia
air
and
water
screening
levels
and
water
quality
guidelines,
to
evaluate
operations
and
emissions.~

To
facilitate
the
commitment
to
reduce
emissions,
du
Pont
has
provided,
and
will
continue
to
provide
to
FMG
companies
where
needed,
its
"
capture
for
destruction"
technology,
license­
free.
In
addition,
Dyneon
and
du
Pont
each
have
offered
to
license
their
respective
company's
"
capture
for
recycle"
technologies.
All
ofthe
companies
are
evaluating
the
applicability
ofavailable
technologies
to
their
processes
and
continue
to
track
APFO
emissions.
Because
ofthe
differences
in
the
manufacturing
processes
and
the
kinds
ofproducts
manufactured,
it
is
not
possible
to
know
whether
these
technologies
will
be
effective,
or
if
they
are,
what
the
final
reductions
will
be.
Nevertheless,
the
companies
are
committed
to
the
minimum
50%
reduction
and
to
taking
additional
steps
as
describedbelow.

The
APFO
Users,
through
the
FMG,
also
continue
to
support
research
on
the
toxicology,
ecotoxicology,
and
environmental
fate
of
APFO,
as
suchresearch
relates
to
the
safe
use
ofAPFO
as
surfactants
in
the
manufacture
and
use
of
fluoropolymers.
Collectively
and
individually,
the
FMG
members
have
worked
with
customers
to
help
them
safely
manage
the
processing
of
fluoropolymer
products,
and
to
help
them
adopt
practices
and
procedures
to
control
employee
exposures.
These
activities
are
essential
parts
of
long­
standing
product
stewardship
programs
and
are
ongoing,
as
described
below.

In
addition,
the
APFO
Users
have,
and
are,
committed
to
working
to
identify
the
possible
routes,
related
to
the
manufacture,
processing,
and
use
of
fluoropolymers,
by
which
the
general
population
could
be
exposed
to
APFO.
The
APFO
Users
have
begun
to
examine
their
products,
embarking
on
the
difficult
analytical
process
of
determining
any
residual
levels.
The
first
step
in
this
effort
was
to
evaluate
methods
for
analysis
ofAPFO.
The
method
evaluation
work
is
under
way,
which
is
necessary
to
meet
EPA's
QAJQC
criteria
and
is
difficult
and
time­
consuming.
As
part
of
that
effort,
the
FMG
published
in
January
2003
Detecting
and
Quan4}
5'
ing
Low
Levels
of
Fluoropolymer
Polymerization
Aids
 
A
Guidance
Document.
A
copy
ofthis
document
was
provided
to
EPA's
technical
staff
for
inclusion
in
the
docket
under
separate
cover.

The
toxicologists
and
scientists
who
participated
in
the
assessment
included
representatives
from
government,
independent
third
party
experts,
and
industry.
The
organizations
represented
included:
West
Virginia
Department
of
Environmental
Protection;
Toxicology
Excellence
for
Risk
Assessment,
Cincinnati,
Ohio;
U.
S.
Environmental
Protection
Agency,
Region
III;
U.
S.
Agency
for
Toxic
Substances
and
Disease
Registry;
EPA
National
office
in
Washington;
and
EPA's
Cincinnati
Laboratory.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
4
of
15
Further
Industry
Commitments
A.
General
Commitment
to
Product
Stewardship
Principles
and
Practices
The
APFO
Users
will
continue
to
follow
the
principles
of
product
stewardship
similar
to
those
described
by
American
Chemistry
Council's
(
ACC)
or
Synthetic
Organic
Chemical
Manufacturers
Assodiation's
(
SOCMA)
Responsible
Care
®
programs
in
their
efforts
to
support
the
toxicological
research,
control
occupational
exposures
in
their
own
facilities,
monitor
employee
health,
assist
customers
in
protecting
their
employees,
and
meet
the
general
commitment
to
reduce
emissions
to
the
environment.

For
example,
as
has
been
done
in
the
past,
through
the
semi­
annual
SPI
FPD
meetings,
an
update
on
information
about
AYFO,
including
the
results
oftoxicology
studies,
coordination
efforts
with
EPA,
and
other
activities,
will
be
provided
to
processormembers
ofthe
fluoropolymer
industry.
High
on
the
list
oftopics
will
be
an
emphasis
for
fluoropolymer
users
on
the
need
for
care
in
handling
and
processing
the
raw
fluoropolymer
products,
and
the
need
to
follow
recommended
procedures
to
protect
their
employees.
Special
attention
will
be
given
to
address
the
practices
and
procedures
ofthose
who
use
dispersions
and
coatings
made
from
dispersions
on
the
safe
handling
ofproducts
that
contain
APFO.
In
addition,
as
part
oftheir
workplace
product
stewardship
efforts
described
below,
the
APPO
Users,
working
with
the
FMG,
will
continue
to
update
and
distribute
the
manuals
and
information
documents
described.

Further
industry
efforts
on
product
stewardship
programs
directed
to
customers
will
focus
on
technical
support
and
assistance
to
fluoropolymer
processors
to
help
them
keep
their
occupational
safety
and
health
programs
current.
While
APFO
Users
recognize
their
responsibilities
as
suppliers
offluoropolymers,
each
processor
and
customer,
as
an
employer,
has
an
independent
and
non­
delegable
duty
to
take
reasonable
steps
to
comply
with
OSHA
standards,
and
where
there
is
a
recognized
hazard
that
is
not
addressed
by
specific
OSHA
standards,
to
assurethat
their
employees
are
protected
from
safety
and
health
hazards.
Accordingly,
the
fluoropolymer
manufacturer's
product
stewardship
role
is
to
provide
the
necessary
information,
assist
in
the
understanding
of
it
and
provide
support
to
processors
using
the
fluoropolymers
so
they
can
meet
their
statutory
obligations.
Specific
steps
and
studies
are
described
below
that
demonstrate
how
the
APFO
Users
will
meet
their
obligations
under
product
stewardship
principles.

The
APFO
Users
generally
will
submit
information
to
and
work
with
EPA
through
the
SPI
FMG.
Such
information
and
studies
may
be
conducted
under
the
auspices
ofindustry
groups
such
as
the
Association
of
Plastics
Manufacturers
in
Europe
(
APME).
The
APFO
Users
will
share
the
information
we
develop
with
EPA.
As
described
below,
the
FMG
continues
to
work
on
additional
studies
that
will
provide
useful
information
to
assess
any
potential
environmental
and
health
effects
ofAPFO
used
in
fluoropolymers.
APFO
Users
are
supportive
of
EPA's
efforts
and
intend
to
assure
that
EPA
has
adequate
information
to
understand
the
benefits,
and
any
risks,
ofAPFO
use
in
fluoropolymers.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
5
of
15
B.
Data
Quality
APFO
Users
recognize
the
importance
of
assuring
good
data
quality.
EPA's
recently
issued
QAIQC
Guidelines4
describe
EPA's
efforts
to
maximize
the
quality
of
environmental
information
made
available
to
the
public
in
terms
ofquality,
integrity,
reliability
and
validity
of
the
data
disseminated.
APFO
Users
will
incorporate
the
guidance
contained
in
EPA's
QA/
QC
guidelines
into
their
research
and
monitoring
programs
to
assure
that
sound
scientific
information
is
available
to
EPA
and
the
public.

C.
Specific
Commitments
I.
Supporting
EPA
Efforts
to
Involve
CDC
in
Testing
Programs
The
APFO
Users
support
adding
APFO
to
the
CDC
N}
IANES
process.
To
facilitate
that
step,
work
is
underway
to
confirm
the
validity
ofthe
analytical
method
and
sampling
protocol
for
analyzing
human
blood
for
the
presence
ofAPFO,
and
the
results
will
be
shared
with
CDC.
Efforts
will
be
made
to
have
the
analytical
methodology
published
in
a
peer­
reviewed
journal
so
it
will
be
widely
available.
In
addition,
and
in
the
further
interest
of
adding
transparency
to
the
process,
there
will
be
support
and
assistance
for
one
or
more
independent
laboratories
to
become
qualified
to
perform
the
validated
method.

2.
Toxicology
Research
Under
the
auspices
ofthe
APME,
the
following
additional
studies
will
be
completed
on
the
schedule
noted:

Study
Description
Anticipated
Report
Date~
Acute
toxicity
in
daphnia
May2003
Acute
toxicity
in
trout
May
2003
Algal
growth
July
2003
Chronic
toxicity
in
daphnia
June
2003
Chronic
toxicity
in
trout
November
2003
Adsorptionldesorption
soil
studies
June
2003
ADE
mass
balance
in
rats
June
2003
Protein
binding;
rat/
human
August
2003
"
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency,"
announced
in
67
F.
R.
63657,
October
15,
2002.
Quality
Assurance
for
Data
Collection;
5360.1/
A2
May
2000.
Based
on
commitments
from
contracting
laboratories,
we
believe
these
dates
can
be
met.
EPA
will
be
advised
of
any
changes
in
the
reporting
schedule.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
6
of
15
Study
Description
Anticipated
Report
Dates
Physiologically
based
kinetic
modeling
October
2003
Mechanistic
studies
ofpancreatic
tumor
October
2003
induction
in
rats.

Industry
plans
to
conduct
an
additional
study
to
determine
parameters
forroute­
to­
route
extrapolation
(
oral
to
inhalation),
and
the
protocol
was
discussed
with
EPA
scientists.
Timing
for
the
anticipated
report
date
will
be
communicated
when
the
final
bid
for
the
project
is
accepted.

Copies
ofthe
final
reports
for
these
studies
will
be
submitted
to
EPA
promptly
upon
receipt.
EPA
will
be
apprised
immediately
if
any
substantially
new
and
unanticipated
information
develops
as
a
result
of
the
research
programs
consistent
with
current
requirements;
the
above
schedule
does
not,
of
course,
supersede
any
statutory
reporting
obligations.

Following
EPA's
QA/
QC
guidelines,
the
reports
will
include
documentation
to
allow
EPA
to
evaluate
the
validity
of
the
studies.
This
validation
will
enable
EPA
to
assure
that
the
information
provided
by
the
companies
can
be
disseminated
to
the
public
consistent
with
EPA's
data
quality
guidelines.
Through
the
FMG,
the
APFO
Users
will
promptly
submit
final
reports
of
these
studies
to
EPA
and
consult
with
EPA
on
what
additional
studies
would
be
beneficial.

3.
Understanding
Routes
ofExposure
Although
there
is
no
known
evidence
of
adverse
human
health
or
environmental
effects
to
date
related
to
APFO,
the
APFO
Users
agree
with
EPA
that
it
is
useful
to
examine
the
potential
for
human
and
environmental
exposure
to
APFO
to
determine
where
potential
exposures
may
have
occurred
or
currently
occur.
Such
research
will
include,
but
may
not
be
limited
to
(
a)
sites
where
APFO
is
manufactured;
(
b)
sites
that
use
APFO
to
make
fluoropolymers;
(
c)
sites
that
use
fluoropolymer
dispersions
containing
APFO;
and
(
d)
articles
of
commerce
containing
fluoropolymers,
including
dry
fluoropolymer
products
and
dispersion
coated
products,
that
might
lead
to
general
population
exposure
related
to
the
fluoropolymer
industry.

D.
Specific
Product
Stewardship
Activities
by
Site
1.
Product
Stewardship
at
Sites
Where
APFO
Is
Manufactured
in
the
U.
S.

Consistent
with
the
principles
ofResponsible
Care
®
,
any
APFO
User
who
decides
to
manufacture
APFO
for
commercial
use
in
the
United
States
(
including
current
manufacturers)
will
first
notify
EPA
and
will
review
its
product
stewardship
program
with
EPA
covering
the
provisions
listed
in
Addendum
III
to
this
letter,
which
applies
only
to
APFO
manufacturing.

As
ofthe
date
ofthis
letter,
only
one
company
has
decided
to
manufacture
APFO
in
the
United
States
for
use
in
fluoropolymer
manufacturing.
That
company
is
du
Pont,
which
already
has
committed
to
adopting
the
steps
in
Addendum
III
as
part
of
its
operating
practices.
Because
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
7
of
15
of
antitrust
considerations,
APFO
Users
are
legally
barred
from
seeking
to
enforce
any
kind
of
group
sanction
against
a
future
U.
S.
manufacturer
that
does
not
adopt
Addendum
III
as
part
of
its
operating
practices.
They
also
cannot
take
any
steps
that
might
be
construed
by
the
U.
S.
antitrust
enforcement
agencies
as
anti­
competitive.
However,
EPA
would
appear
to
have
adequate
authority
to
assure
that
future
U.
S.
manufacturers
of
APFO,
if
any,
follow
the
provisions
outlined
in
Addendum
III
and
commit
to
adequate
product
stewardship.

2.
Product
Stewardship
at
Sites
in
the
U.
S.
That
Use
APFO
To
Make
Fluoropolymers
As
noted
above,
the
APFO
Users
earlyon
made
a
specific
and
substantial
voluntary
Emissions
Reduction
Commitment
regarding
the
amounts
ofAPFO
emitted
from
their
manufacturing
facilities.
Based
on
the
baseline
data
from
global
materials
balance
submitted
to
EPA
in
September
2002,
as
described
above,
APFO
Users,
as
FMG
members,
have
committed
to
modifying
their
processes
to
reduce
AFPO
emissions,
on
a
global,
individual
company­
wide
basis,
by
a
minimum
of
50%
for
calendar
year
2006.
This
reduction
will
be
achieved
by
reducing
the
use,
recycling
a
greater
proportion,
or
by
capturing
and
destroying
it.
In
addition,
at
each
ofthe
fluoropolymer
manufacturing
sites
listed
below,
the
APFO
Users
will:

1)
Develop
site­
specific
plans
to
assess
or
model
levels
of
APFO
in
air
and
water
around
theirmanufacturing
sites;
development
ofthe
plans
will
begin
not
later
than
30
days
after
the
date
of
this
letter;
2)
Conduct
site­
specific
air
dispersion
modeling,
using
the
EPA
approved
Industrial
Source
Complex
Short
Term
3
(
ISCSTS)
model,
as
described
in
EPA's
Guideline
on
Air
Ouality
Models
(
40
C.
F.
R.
Part
51,
Appendix
W),
0
and
assess
the
results
using
the
air
screening
levels
established
in
West
Virginia;
3)
As
necessary
to
implement
a
site­
specific
plan,
conduct
ground
and
surface
water
analysis,
and
assess
the
results
using
the
water
screening
levels
established
in
West
Virginia;
and
4)
Use
the
West
Virginia
screening
levels
to
determine
what
additional
actions,
if
any,
may
need
to
be
taken,
after
reviewing
the
information
with
EPA.

These
commitments
will
be
undertaken
at
the
following
sites:

http://
www.
epa.
gov/
scramo0
l/
guidance/
guide/
ayyw
01
.
pdf
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
8
of
15
a)
duPont
Washington
Works
Plant
Rt.
892
South
Washington,
WV
26181
b)
Dyneon
1400
State
Docks
Road
Decatur
Alabama
3
5609­
2206
c)
Daikin
905
State
Docks
Road
Decatur,
AL
35601
Six
months
afler
this
Letter
is
signed,
reports
will
be
submitted
by
each
company
for
each
site
on
progress
made
with
regard
to
environmental
assessments.

In
addition,
the
APFO
Users
will:

1)
Within
30
days
ofthis
letter,
provide
a
list
of
each
site
in
the
United
States
where
APFO
is
used
to
make
fluoropolymers
and
which
fluoropolymers,
including
CAS
numbers,
are
produced
at
that
site;
2)
For
each
listed
site,
beginning
in
2004
for
the
2003
calendar
year
and
continuing
through
the
2008
calendar
year,
provide
EPA
with
a
biennial
report,
describing
total
emissions
ofAPFO
at
each
site,
on
a
calendar
year
basis.
The
reports
will
be
submitted
to
EPA
within
180
days
of
the
end
of
each
reporting
period
and
will
include
CAS
numbers
for
the
substances
reported;
3)
For
each
listed
site
that
uses
APFO,
continue
to
conduct
industrial
hygiene
monitoring
in
the
workplace
of
their
employees,
measuring
exposure
to
APFO
and
providing
results
to
exposed
employees.
The
results
will
be
used
to
assure
that
employee
exposures
are
controlled
and
to
protect
employees'
health.
The
companies,
as
they
have
in
the
past,
will
assure
that
appropriate
protective
equipment
and
proper
handling
practices
are
used.
They
also
will
continue
to
provide
employees
with
training
on
any
hazards
to
which
they
are
exposed,
the
signs
and
symptoms
ofoverexposure
and
methods
of
proper
handling,
updating
as
new
information
becomes
available,
as
part
oftheir
ongoing
employee
Occupational
Safety
and
Health
Administration
Hazard
Communication
Standard
programs.

As
further
evidence
oftheir
ongoing
commitment,
the
APFO
Users
will
provide
EPA
with
timely
reports
of
their
collective
progress
in
reducing
emissions
and
meeting
the
target
goals
so
that
the
information
can
be
made
part
of
the
public
record.
The
reports
will
be
based
on
estimates
of
annual
emissions,
derived
from
available
sampling
data
and
supplemented
by
best
estimates
when
actual
data
are
not
available,
compared
to
the
original
estimates
provided
to
EPA.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
9
of
15
The
APFO
Users
long
have
followed
American
Conference
of
Governmental
h~
dustrial
Hygienists
(
ACGIIH)
Threshold
Limit
Value
(
TLV)
recommendations
in
assessing
their
occupational
exposures
to
APFO,
and
they
will
continue
to
do
so.
As
other
recommendations
become
available,
the
APFO
Users
will
incorporate
them
into
theirprograms
and,
as
they
have
in
the
past,
work
to
ensure
that
their
employees
are
adequately
protected
based
on
the
best
available
scientific
evidence.

The
APFO
Users
can
provide
EPA
with
details
about
their
individual
occupational
safety
and
health
and
environmental
compliance
programs.
If
asked,
each
APFO
User
will
review
its
environmental
and
occupational
health
data
and
will
describe
and
provide
the
rationale
ofits
monitoring
programs
going
forward.

3.
Product
Stewardship
at
Sites
in
the
U.
S.
That
Use
Fluoropolymer
Dispersions
Containing
APFO
The
APFO
Users
are
committed
to
continuing
their
Product
Stewardship
programs
for
their
customers.
To
assist
in
assessing
the
potential
routes
ofexposure
at
selected
sites
oftheir
customers,
the
APFO
Users,
under
the
auspices
ofthe
FMG,
will:

1)
Engage
a
third­
party
consultant
to
develop
a
representative
material
balance
for
the
fate
of
APFO
contained
in
these
dispersions.
Similar
to
the
information
provided
to
EPA
on
fluoropolymer
manufacturing,
address
in
the
representative
material
balance
how
the
dispersion
is
used
at
the
customer
site
and
potential
emissions
ofAPFO
to
the
environment;
2)
Submit
the
material
balance
to
EPA
and
work
cooperatively
to
identify
and
recommend
appropriate
product
stewardship
elements
to
control
emissions
at
customer
sites.
3)
Target
completion
of
the
material
balance
by
the
end
of2003.

This
project
is
under
way
and
the
contractor
is
being
selected.
We
expect
that
the
results
of
the
materials
balance
will
suggest
what
actual
monitoring
maybe
necessary.
After
the
initial
survey
is
complete,
the
companies
will
review
the
information
to
determine
if
further
research
or
monitoring
is
required,
and,
if
so,
will
work
through
SPI
to
help
customers
conduct
their
necessary
studies.
Among
the
tasks
that
need
to
be
completed
are:
validating
air
sampling
methods
applied
to
customer
sites;
providing
analytical
methods;
and
identifying
consultants
and
laboratories
with
experience
in
collecting
and
analyzing
workplace
air
samples
for
APFO.
The
APFO
Users
will
discuss
plans
for
additional
work
in
this
area
with
EPA.

Finally,
consistent
with
the
product
stewardship
principles
to
which
APFO
Users
firmly
adhere
and
which
are
discussed
above,
the
APFO
Users
will
continue
to
update
information
provided
to
customers
and
users
of
fluoropolymers,
make
the
information
widely
available
and
work
with
customers
to
assure
that
the
information
is
disseminated
downstream
as
appropriate.
Industry
meetings
such
as
the
semi­
annual
FPD
meeting
and
other
venues
where
fluoropolymer
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
10
of
15
users
participate
will
be
used
to
communicate
the
need
to
be
knowledgeable
about
fluoropolymers
and
APFO,
and
the
need
to
take
the
recommended
steps
to
reduce
emissions
from
processor
facilities
and
minimize
potential
processor
employee
exposures.

4.
Product
Stewardship
for
Articles
of
Commerce
Made
with
Fluoropolymers
Fluoropolymer
products
made
with
APFO
are
sold
in
either
a
dry
resin
form
or
as
a
liquid
dispersion.
It
is
the
intent
of
the
APFO
Users
that
APFO
not
be
carried
through
the
manufacturing
and
processing
of
articles
ofcommerce.
To
document
that
this
is
the
case,
the
APFO
Users,
under
the
auspices
ofthe
FMG,
will:

1)
Analyze
representative
articles
ofcommerce
containing
or
made
with
dry
fluoropolymer
resins
for
the
presence
ofAPFO
and
report
the
results
to
EPA.
2)
For
products
coated
or
manufactured
with
liquid
dispersions,
analyze
representative
articles
ofcommerce
for
the
presence
ofAPFO
and
report
the
results
to
EPA.
3)
As
appropriate,
develop
and
disseminate
information
along
with
recommendations
to
processors
for
reducing
the
potential
for
exposure
to
APFO
from
articles
ofcommerce.
4)
Target
completion
ofthe
analysis
of
articles
ofcommerce
by
the
end
of2003.

These
studies
will
be
conducted
by
contract
laboratories
or
in
company
laboratories
using
validated
methods.
The
products
selected
for
analysis
will
be:
(
1)
those
most
likely
to
have
widespread
consumer
use;
and
(
2)
a
representative
sampling
of
industrial
and
commercial
products.

The
articles
ofcommerce
being
tested
will
be
selected
from
products
made
with
fluoropolymers
supplied
by
APFO
Users.
There
are
some
articles
of
commerce
made
from
imported
fluoropolymers
that
are
not
produced
by
APFO
Users
and
also
some
articles
of
commerce
made
outside
the
U.
S.
from
fluoropolymers
not
supplied
by
APFO
Users.

Based
on
preliminary
data
obtained
using
preliminary
methods,
it
is
our
expectation
that
articles
ofcommerce
made
from
dry
fluoropolymers
will
have
no
significant
amounts
of
APFO
present,
and
that
most
coated
products
will
show
similar
results.
An
example
can
be
found
in
the
recent
submission
by
du
Pont
to
EPA
showing
that
cookware
coated
with
products
made
with
fluoropolymer
resins
demonstrated
no
detectable
level
of
APFO
with
current
methods
accepted
by
the
U.
S.
Food
and
Drug
Administration
for
analysis
of
food
contact
products.

Based
on
these
analyses,
the
APFO
Users
will
provide
EPA
with
potential
exposure
source
and
route
information
for
public
dissemination
as
it
is
developed.
These
data
will
be
used
to
determine
whether
those
sources
contribute
to
potential
exposure
to
the
general
population
and
to
develop
appropriate
practices,
methods,
and
measures
to
reduce
and
control
the
emissions
of
APFO.
Again,
these
will
be
discussed
with
EPA
as
they
are
being
developed.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
11
of
15
*
*
*
*
*

The
APFO
Users
appreciate
the
opportunity
to
work
with
EPA
on
this
matter
and
agree
that
close
coordination
ofour
efforts
and
sharing
of
information
is
important.
Accordingly,
we
will
continue
to
communicate
with
EPA
as
important
relevant
information
arises
and
would
appreciate
similar
consideration.
As
new
information
becomes
available,
the
APFO
Users
are
committed
to
work
with
EPA
to
take
appropriate
further
actions
in
light
ofthe
information
that
is
developed.

In
closing,
we
would
like
to
emphasize
that
the
fluoropolymer
industry
is
committed
to
the
continued
safe
manufacture,
processing
and
use
of
fluoropolymers
and
to
working
withEPA.

Respectfully
Submitted,

APFO
Users,
attached
Attachments
Addendum
I:
Fluoropolymers
and
Fluoroelastomers
That
MayBe
Made
With
APFO
Addendum
II:
Background
and
Voluntary
Activities
Appendix
I:
Partial
List
of
Studies
on
APFO
in
EPA's
Docket
Addendum
III:
Manufacture
ofAPFO
The
Honorable
StephenL.
Johnson
March
14,
2003
Page
12
of
15
Name:
`
Charles
D.
Allen
Title:
President
Asahi
Ola~
sFluoropolymers
USA,
inc,
The
Honorable
Stephen
L.
Johnson
March
14,2003
~
a.
ge13
o15
7
_____
NameT~
~
Title:
FL~
4t4
Daikin
America,
Inc.
The
Honorable
Stephen
L.
Johnson
March
14,
2003
Page
14
of
15
4~
7
Nan~
amesE.
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D
nLLC
The
Honorable
Stephen
L
Johnson
March
14,
2003
Page
15
oflS
Name:
Ric~
J.
Ang4o
Title:
ViccPresident
~`
Genera1Manager
E.
I.
dii
Pont
de
Nemours
and
Company
Addendum
I
March
14,
2003
Page
1
of
I
Addendum
I
fiiii~
opolymersand
Fluoroelasfomers
Which
May
Be
Made
With
APFO
Polymer
family
CAS
Number
Monomers
FhuoropolynTlers
~
TFE
9002­
84­
0
TFE
FE!'
25067­
11­
2
ft1F1~~
~
FA
26655­
00­
5
TFE,
PPVE
THV
25
190­
89­
0
TFE,
HFP,
VDF
~
TFE
68258­
85­
5
TFE,.
E___________________
THE
35560­
16­
8
TFE,
HFP,
E
Pluoroelastomers
Copolymers
ferpolymers___________
tBase
resistant
elastomers
Perfluoroelastomers
9011­
i~
r9
VDF,
HFP
25190­
89~
0t~
FE,
1iPP,`
VDF
54675­
89­
7,
TTFE,
VDF,
~
27029­
05­
6
JTf~
L__________________
26425­
79­
6
J~~
y_
PVE
CTFE
elastomers
90
10­
75­
7
CTFE,
VFD
~!~`_
temperature
elastomers
26425­
79­
6
TFE,
PMVE
Monomers
Used
in
Fluorop~
y~
rs
Acronym
Monomer
name
CAS
Number
Chlorotrifluoroethylene
79­
38­
9
CTFE______
TFE
HFP
Tetrafluoroethylene
116­
14­
3
Hexafluoropropylene
116­
15­
4
VDF
Vinylidene
fluoride
75­
38­
7
PMVE
Periluoromethyl
vinyl
ether
1187­
93­
5
Perfluoropropyl
vinyl
ether
1623­
05­
8
Ethylene
74­
85­
1
Propylene
115­
07­
1
PPVE
P
Addendum
H
Background
and
Voluntary
Activities
Background
A.
APFO
Use
in
Fluoropolymers
Ammonium
perfluorooctanoate,
orAPFO,
is
a
surfactant
that
acts
as
a
polymerization
aid
to
make
certain
base
fluoropolymer
resins.
APFO
is
currently
the
most
widely
used
surfactant
for
fluoropolymer
manufacture
and
is
essential
in
these
processes.
APFO
typically
is
used
in
low
concentrations
(
less
than
1%)
in
the
fluoropolymer
manufacturing
process
and
in
a
few,
very
limited
industrial
applications.
Because
of
its
use
as
a
polymerization
aid,
it
is
substantially
removed
in
finishing
steps
in
dry
fluoropolymer
manufacturing.
In
water­
borne
dispersions,
which
are
used
to
make
various
coatings,
it
allows
application
ofthe
dispersion,
but
it
is
not
intended
to
be
part
of
the
fluoropolymer
or
the
finished,
end­
use
product.

It
is
critical
to
understand
the
role
ofAPFO
in
the
fluoropolymer
industry.
The
surfactant
properties
ofAYFO
facilitate
the
manufacture
offluoropolymers
and
fluoroelastomers,
but
it
does
not
contribute
to
the
performance
of
the
end­
use
product.
Therefore,
it
is
not
intended
to
be
 
or
needed
 
in
the
end­
use
products
made
with
it.

In
fact,
most
of
the
products
made
from
fluoropolymers
require
heat
treatment
that
removes
or
destroys
the
majority
ofthe
APFO
in
the
fluoropolymer
resin
before
the
products
made
with
fluoropolymers
leave
the
manufacturing
facility
or
are
used.
Therefore,
fluoropolymer
products
do
not
normally
present
a
route
of
exposure
to
APFO
once­
they­­
leave­
the
hands
ofthe
end­
use
product
manufacturer.

Further,
APFO
Users
have
long
recognized
their
obligation
to
responsible
use
of
chemicals
such
as
APFO
in
their
processes
and
products
and
long
ago
voluntarily
committed
themselves
to
establishing
and
supporting
responsible
health
and
environmental
practices
in
the
manufacture
and
use
offluoropolymers.
This
has
been
done
to
minimize
the
potential
effect,
if
any,
these
activities
have
on
human
health
and
the
environment,
and
to
support
the
continued
safe
manufacture
and
use
offluoropolymers
made
using
APFO.
Those
commitments
continue
today,
and
are
exemplified
by
the
additional
commitments
the
APFO
Users
describe
in
this
letter.

Also
important
to
understand
is
that,
despite
more
than
30
years
of
intensive
research
into
alternatives,
none
has
been
found,
as
was
presented
by
du
Pont
representatives
on
behalf
ofThe
Society
ofthe
Plastics
Industry,
Inc.
(
SPI)
Fluoropolymers
Manufacturing
Group
to
the
U.
S.
Environmental
Protection
Agency
(
EPA)
on
April.
23,
2001.
Driving
the
research
were
considerations
regarding
persistence,
the
existence
of
only
one
supplier,
and
the
need
formore
effective,
cheaper
alternatives.
Indeed,
fluoropolymer
manufacturers
have
tested
literally
dozens
of
compounds,
and
all
have
been
rejected
due
to
technical
problems
or
potential
safety
concerns
that
made
them
unsuitable
for
such
use.
Addendum
II
March
14,
2003
Background
and
Voluntary
Activities
Page
2
of8
B.
The
Role
ofFluoropolymers
in
Society
Fluoropolymers
are
essential
to
a
variety
oftechnologies
and
products
that
enhance
human
life
and
promote
environmental
improvements.
Ranging
from
power
generation
to
emission
controls
on
vehicles,
to
semiconductor
chip
manufacturing
and
aerospace
applications,
fluoropolymers
provide
superior
performance
in
products
that
contribute
to
increased
safety
in
our
offices,
homes,
businesses,
and
communities.

Fluoropolymers
provide
unique
and
critical
performance
properties
in
"
system
critical"
applications
that
protect
and
benefit
people
and
the
environment.
Fluoropolymers
a~
eamong
the
few
plastic
materials
that
can
withstand
the
temperatures
inside
the
engine
compartments
of
aircraft.
They
also
have
high
resistance
to
a
broad
range
offuels,
solvents
and
corrosive
chemicals,
as
well
as
excellent
electrical
insulating
properties.
These
unique
properties
provide
critical
performance
characteristics
needed
to
prevent
fire,
fluid
emission,
electrical
overloading
or
similar
emergencies
in
many
high­
performance
applications.
And,
for
virtually
all
these
applications,
fluoropolymers
are
the
only
materials
that
meet
system
performance
needs
in
high
temperatures
and
harsh
chemical
environments.

C.
50
Years
ofExperience
of
Safe
APFO
Use
APFO
has
been
used
safely
and
without
apparent
adverse
effects
on
human
health
for
more
than
50
years,
in
part
because
ofthe
workplace
safety
programs
the
APFO
Users
had
in
place.
This
conclusion
is
supported
by
epidemiology
and
other
human
health
studies
(
contained
in
EPA's
public
record
and
published
in
the
scientific
literature)
on
employees
both
at
APFO
production
and
fluoropolymer
manufacturing
facilities.

Multiple
studies,
the
first
ofwhich
was
published
in
1980,
have
examined
the
healthrelated
experience
of
employees
in
the
APFO
manufacturing
process.
These
studies
looked
for
health
effects
similar
to
the
effects
observed
in
animal
studies.
This
effort
continues
even
now.
No
studies
of
the
employees
who
have
direct
exposure
showed
any
unusual
or
unexpected
pattern
ofillnesses
or
deaths
from
any
disease,
including
cancer.

Based
on
this
experience,
and
the
ongoing
health
and
safety
research
theyhave
supported
and
that
has
been
published
over
the
years,
APFO
Users
do
not
believe
that
current
levels
of
exposure
to
APFO
cause
adverse
effects
to
human
health
or
the
environment.

D.
Recent
Events
Triggering
Interest
in
APFO
In
May
2000,
3M
announced
that
it
would
be
"
phasing
out
of
the
perfluorooctanyl
chemistry
used
to
produce
certain
repeflents
and
surfactant
products."
Subsequent
to
the
3M
announcement,
EPA
broadened
their
interest
in
a
series
of
fluorochemicals
that
they
considered
to
be
persistent
in
the
environment.
This
interest
has
been
heightened
recently
by
the
discovery
that
certain
of
these
fluorochemicals
are
found
at
trace
levels
in
the
blood
ofthe
US
population.
Addendum
II
March
14,
2003
Background
and
Voluntary
Activities
Page
3
of
8
Voluntary
Activities
ofAPFO
Users
and
Manufacturers
The
users
and
manufacturers
ofAPFO
have,
both
individually
and
collectively,
supported
research
into
the
potential
effects
on
human
health
and
the
environment,
and
have
adopted
in
their
own
workplaces
health
and
safety
practices
to
minimize
employee
exposure.
They
have
funded
research
on
the
toxicology,
both
for
animal
and
environmental
effects
and,
as
noted
above,
conducted
epidemiology
studies
to
be
sure
that
human
health
has
not
been
affected
by
the
use
ofAPFO.
In
addition,
they
have
developed
control
recommendations
for
the
safe
use
and
handling
of
fluoropolymers
and,
specifically,
for
dispersions
containing
APFO.
These
recommendations
have
been
disseminated
to
customers
through
publications
and
meetings
of
the
SPI
Fluoropolymers
Division
and
the
Association
ofPlastics
Manufacturers
in
Europe
(
APME),
in
addition
to
the
information
provided
individually
by
the
APFO
Users
through
Material
Safety
Data
Sheets
(
MSDS)
and
other
technical
information
sources.

The
studies
the
APFO
Users
and
manufacturers
have
funded
were
conducted
on
APFO
and
a
related
chemical,
perfluorooctanoic
acid
(
PFOA).
2
These
studies
are
among
those
that
3M
and
du
Pont
have
submitted
to
EPA.
The
number
of
research
studies
on
APFO
included
in
EPA's
docket
is
large.
A
brief
list
of
some
ofthe
studies,
including
studies
on
human
health
assessments,
is
included
in
Appendix
1
of
this
Addendum.

To
coordinate
their
efforts
to
assess
and
respond
to
EPA's
concerns,
the
manufacturers
of
fluoropolymer
resins,
who
are
also
members
of
SPI's
Fluoropolymers
Division,
formed
the
FMG.
The
mission
ofthe
FMG
is
to
promote
the
continued
safe
manufacture
and
use
of
fluoropolymers
made
using
fluoropolymer
polymerization
aids
such
as
APFO
while
establishing
and
supporting
responsible
use
offluoropolymer
products
and
promoting
environmental
stewardship.
The
APFO
Users,
working
with
others
in
the
FMG,
will
continue
to
support
the
safe
use
ofAPFO,
will
work
with
EPA
to
understand
the
information
that
exists
and
to
develop
research
programs
to
fill
in
the
gaps.

The
APFO
Users,
as
members
ofthe
FMG,
first
presented
information
about
the
FMG's
work
to
EPA
in
September
2000.
Since
then,
the
APFO
Users,
through
the
FMG
and
the
APME,
have
continued
to
provide
information
on
manufacturing,
distribution
and
use
ofAPFO,
as
well
as
the
available
data
on
systemic
toxicity
and
environmental
fate
ofAPFO.
APFO
Users
have
reviewed
EPA's
preliminary
assessment
of
the
potential
hazards
to
human
health
and
the
environment
associated
with
exposure
to
APFO,
entitled
"
Revised
Draft
Hazard
Assessment
of
Perfluorooctanoic
Acid
and
its
Salts,"
dated
November
4,
2002.
The
FMG
has
also
provided
I
While
APFO
is
the
product
used
in
fluoropolymers,
PFOA
is
the
substance
that
has
been
found
in
some,

but
not
all,
the
environmental
andblood
samples
that
have
been
tested.
PFOA
is
also
the
chemical
that
has
usually
been
tested
in
animal
studies,
because
APFO
dissociates
in
water
into
PFOA
and
ammonium
ions.
EPA
has
assigned
OPPTS
DocketNumber
AR226
for
all
submissions
on
perfluorinated
substances.
AR226
also
contains
documents
pertaining
to
other
perfluorinated
chemical
substances.
The
APFO
Users
believe
that
the
matters
concerning
APFO
are
different
from
those
associated
with
the
other
chemical
substances
included
inEPA
OPPTS
Docket
Number
AR226.
Addendum
II
March
14,
2003
Background
and
Voluntary
Activities
Page
4
of
8
EPA
with
a
number
of
new
documents
and
information
about
the
use
ofAPFO
in
fluoropolymers.

A.
Fluoropolymer
Manufacturers'
Product
Stewardship
Commitment
The
APFO
Users
specifically
concur
with
and
subscribe
to
the
product
stewardship
principles
similar
to
those
described
by
American
Chemistry
Council's
(
ACC)
and
Synthetic
Organic
Chemical
Manufacturers
Association's
(
SOCMA)
Responsible
Care
®
programs.
The
APFO
Users'
product
stewardship
programs
incorporate
provisions
(
1)
addressing
the
development
and
dissemination
ofhealth,
safety,
and
environmental
information;
(
2)
adopting
safe
practices
to
limit
risks
to
the
community,
customers,
and
employees
from
manufacturing
and
processing
of
fluoropolymer­
based
products;
(
3)
establishing
proper
practices
for
effective
health
and
safety
management;
and
(
4)
instituting
risk
management
approaches.
These
ongoing
programs
represent
a
substantial
commitment
of
resources
and
efforts,
and
the
activities
described
below
are
evidence
ofthat
commitment.

B.
Toxicology
Research
A
number
of
the
toxicology
studies
relevant
to
APFO
that
have
been
submitted
to
EPA,
some
ofwhich
were
conducted
in
the
early
1970s,
were
funded
by
fluoropolymer
industry
members,
including
the
users
and
manufacturers
of
APFO.
More
recently,
the
studies
conducted
were
organized
and
coordinated
by
the
Toxicology
Working
Group
ofthe
Fluoropolymer
Committee
of
APME.
These
studies,
contained
in
AR226,
examine
acute
and
chronic
health
effects
and
include
two
carcinogenicity
studies,
a
two­
generation
developmental
and
reproductive
study,
and
studies
of
effects
on
tissues
and
organs,
including
in
the
liver,
pancreas
and
reproductive
organs,
in
laboratory
animals.

Other
studies
have
provided
information
on
the
physical
and
chemical
characteristics
of
APFO
and
its
potential
effects
in
a
variety
of
species,
including
fish,
microorganisms
and
other
species.
The
APFO
Users'
commitment
to
support
EPA's
efforts
is
demonstrated
through
the
FMG
and
the
APME
research
programs.

C.
Workplace
Product
Stewardship
Activities
Directed
Toward
Protecting
Fluoropolymer
Manufacturing
Employees
As
a
matter
of
good
industrial
hygiene
practice,
the
APFO
Users
have
occupational
health
and
safety
programs
to
protect
their
employees,
including
those
who
handle
APFO
in
fluoropolymer
manufacturing.
Over
the
years,
as
more
information
has
become
available,
3M
has
provided
information
on
APFO
to
the
fluoropolymer
manufacturers,
along
with
recommendations
for
proper
handling
and
use.
Among
the
most
significant
changes
in
handling
was
the
decision
to
sell
the
substance
in
a
wet
form
to
reduce
dusting
and
thereby
employee
exposure.
Additional
precautions
to
prevent
skin
contact
and
otherwise
limit
exposure
include
the
use
ofprotective
clothing,
gloves,
face
shields,
and
respirators,
disposable
garments,
installation
of
general
mechanical
and
local
exhaust
ventilation
systems,
and
other
handling
practices
as
recommended
in
the
manufacturer's
MSDS.
These
precautions,
the
effects
of
Addendum
II
March
14,
2003
Background
and
Voluntary
Activities
Page
5
of
8
APFO,
and
other
important
information
are
discussed
with
employees
as
part
of
ongoing
Occupational
Safety
and
Health
Administration
(
OSHA)
Hazard
Communication
Standard
(
HCS)
programs
and
on
MSDS
and
product
labels.

All
the
companies
adopted
these
various
practices
to
keep
employee
exposures
below
the
current
American
Conference
of
Governmental
Industrial
Hygienists
(
ACGIH)
Threshold
Limit
Value
(
TLV)
ofan
eight­
hour
time­
weighted­
average
(
TWA)
of
0.01
milligram
per
cubic
meter
(
mg/
rn3).
The
companies
have
used
industrial
hygiene
monitoring
to
document
the
efficacy
of
control
measures
and
employee
exposures
as
needed.
The
companies
remain
committed
to
meeting
the
occupational
standards
and
guidelines
recommended
by
organizations
such
as
ACGIH
as
they
are
updated.

D.
Existing
Product
Stewardship
Activities
Directed
Toward
Customers
APFO
Users
have
long­
standing
product
stewardship
programs
that
incorporate
the
principles
and
practices
similar
to
those
of
the
Responsible
Care
®
program
as
it
applies
to
obligations
to
customers.
They
have
worked
collectively
and
individually
to
provide
health,
safety
and
environmental
information
to
customers
and
distributors.
Commensurate
with
product
risk,
they
select
and
periodically
review
customers
and
distributors
to
foster
proper
use,
handling,
recycling
and
disposal
as
well
as
the
transmittal
of
appropriate
information
to
downstream
users.
If
improper
practices
involving
a
product
are
identified,
the
APFO
Users
work
with
the
customer
or
distributor
to
improve
those
practices.
Each
of
the
companies
evaluates
its
business
relationships
in
light
ofthese
principles.

The
AFFO
Users,
with
other
FMG
members,
have
worked
for
many
years
to
assure
that
people
who
work
with
fluoropolymers
have
sufficient
information
to
use
them
safely.
As
required
under
the
OSHA
HCS,
the
FMG
companies
have
routinely
included
information
about
safe
handling
oftheir
products
on
MSDS,
including
information
about
toxicity,
protective
equipment,
and
safe
methods
and
practices.
In
addition,
the
companies
have
collectively
worked
to
disseminate
widely
safety
and
health
information
using
additional
methods
and
documents,
going
beyond
what
current
law
requires.

One
of
the
first
collective
efforts
in
this
regard
was
the
creation
of
a
Guide
to
the
Safe
Handling
ofFluoropolymer
Resins
(
Safe
Handling
Guide)
in
1992.
A
3~
Edition
was
published
in
1998,
incorporating
the
recommendations
from
all
the
manufacturers
of
fluoropolymer
resins,
and
a
copy
already
has
been
provided
to
EPA.
Those
recommendations
included
chapters
on
Potential
Health
Effects,
Regulations,
Safety
Measures,
Waste
Disposal,
and
Emergency
Measures.
Although
focused
on
fluoropolymer
resins,
the
Guide
includes
information
on
some
ingredients,
including
surfactants,
used
in
fluoropolymer
resins.
Health
effects
of
some
byproducts
also
were
included.

The
Chapter
on
Safety
Measures
has
extensive
discussions
of
steps
to
take
to
avoid
exposure
to
hazardous
chemicals
that
might
be
present
when
processing
fluoropolymers.
Specific
emphasis
was
placed
on
using
local
exhaust
ventilation
because
ofthe
by­
products
of
thermal
degradation,
and
information
was
provided
on
specific
processing
activities
and
their
Addendum
II
March
14,
2003
Background
and
Voluntary
Activities
Page
6
of
8
unique
associated
hazards.
Recommendations
included
required
protective
clothing
and
equipment,
such
as
respirators
and
gloves,
as
well
as
other
garments
to
prevent
skin
contact.
Finally,
an
extensive
education
effort
was
conducted
through
SPI
FPD's
semi­
annual
meetings
and
seminars
on
the
Safe
Handling
Guide
and
its
updates.

The
effort
to
update
the
Safe
Handling
Guide,
now
in
its
3rd
Edition,
and
other
documents
is
an
ongoing
process
that
normally
involves
processor
members
of
the
FPD.
Information
on
APFO
will
be
included
and
highlighted.

In
addition,
the
FMG
prepared
and
published
its
Guide
to
the
SafeHandling
of
Fluoropolymer
Dispersions
in
October
2001
that
describes
APFO
and
related
compounds
and
their
use
in
fluoropolymer
dispersions
in
detail.
This
document
is
currently
being
updated
and
a
revised
copy
will
be
provided
as
soon
as
it
is
available.
Addendum
II
March
14,
2003
Background
and
Voluntary
Activities
Page
7
of
8
Appendix
1
Partial
List
of
Studies
on
APFO
in
EPA's
Docket
Studies
funded
by
APFO
Users
and
manufacturers:

1)
Fayerweather,
"
Liver
Study
ofWashington
Works
Employees
Exposed
to
CS:
Results
ofBlood
Biochemistry
Testing,"
January
15,
1981;
2)
Gortner,
E.
G.
(
1981).
"
Oral
Teratology
Study
of
T­
2998CoC
in
Rats."
Safety
Evaluation
Laboratory
and
Riker
Laboratories,
Inc.
Experiment
No.
0681
TRO
110,
December
1981;
3)
Gortner,
E.
G.
(
1982).
"
Oral
Teratology
Study
ofT­
3l4lCoC
in
Rabbits."
Safety
Evaluation
Laboratory
and
Riker
Laboratories,
Inc.
Experiment
No.
068
1TB0398,
February
1982;
4)
Biker
(
1983).
"
Two­
Year
Oral
(
Diet)
Toxicity/
carcinogenicity
Study
of
Fluorochemical
FC­
l43
in
Rats."
Riker
Laboratories,
Inc.,
ExperimentNo.
0281CR0012,
May
1983;
5)
Staples,
R.
E.,
Burgess,
B.
A.,
and
Kerns,
W.
D.
(
1984).
"
The
embryo­
fetal
toxicity
and
teratogenic
potential
ofammonium
perfluorooctanoate
(
PFOA)
in
the
rat."
Fundamental
and
Applied
Toxicology,
vol.
4,
pp.
429­
440;
6)
York,
R.
G.
(
2002).
"
Oral
(
Gavage)
Two­
generation
(
One
Litter
per
Generation)
Reproduction
Study
of
Ammonium
Perfluorooctanoic
Acid
(
PFOA)
in
Rats."
Argus
Research
laboratories,
Inc.
Protocol
Number
418­
020,
March
26,
2002;

Studies
funded
by
APFO
Manufacturers:

7)
Gilliland,
F.
D.
(
1992).
"
Fluorocarbons
and
Human
Health:
Studies
in
an
Occupational
Cohort."
Doctoral
dissertation.
Minneapolis
(
MN),
University
ofMinnesota;
8)
Gilliland,
F.
D.
and
Mandel,
J.
S.
(
1993).
"
Mortality
among
employees
ofa
perfluorooctanoic
acid
production
plant."
Journal
of
Occupational
Medicine,
vol.
35,
pp.
950­
954;
9)
Gilliland,
F.
D.
and
Mandel,
J.
S.
(
1996).
"
Serum
perfluorooctanoic
acid
and
hepatic
enzymes,
lipoproteins
and
cholesterol:
a
study
of
occupationally
exposed
men."
American
Journal
of
Industrial
Medicine,
vol.
29,
pp.
560­
568;
10)
Olsen,
G.
W.,
Gilliland,
F.
D.,
Burlew,
M.
M.,
Burris,
J.
M.,
Mandel,
J.
S.
and
Mandel,
J.
H.
(
1998).
"
An
epidemiologic
investigation
ofreproductive
hormones
in
men
with
occupational
exposure
to
perfluorooctanoic
acid."
Journal
ofOccupational
and
Environmental
Medicine,
vol.
40,
pp.
614­
622;
11)
Olsen,
G.
W.,
Burr,
J.
M.,
Burlew,
M.
M.,
and
Mandel,
J.
H.
(
2000).
"
Plasma
cholecystokinin
and
hepatic
enzymes,
cholesterol
and
lipoproteins
in
ammonium
perfluorooctanoate
production
workers."
Drug
and
Chemical
Toxicology,
vol.
23,
pp.
603­
620;
12)
Alexander,
B.
H.
(
2001
a).
"
Mortality
Study
of
Workers
Employed
at
the
3M
Cottage
Grove
Facility."
Minneapolis
(
MN),
University
of
Minnesota;
13)
Alexander,
B.
H.
(
2001b).
"
Mortality
Study
of
Workers
Employed
at
the
3M
Decatur
Facility."
Minneapolis
(
MN),
University
ofMinnesota;
Addendum
II
March
14,2003
Background
and
Voluntary
Activities
Page
8
of
8
14)
Olsen,
G.
W.,
Logan,
P.
W.,
Simpson,
C.
A.,
Burris
J.
M.,
Burlew,
M.
M.,
Lundberg,
J.
K.,
and
Mandel,
J.
H.
(
2001a).
"
Descriptive
Summary
of
Serum
Fluorochemical
Levels
among
Employee
Participants
ofthe
Year
2000
Decatur
Fluorochemical
Medical
Surveillance
Program."
St.
Paul
(
MN),
3M
Company.
U.
S.
EPA
Docket
AR­
226­
1030a020a;
15)
Olsen,
G.
W.,
Burlew,
M.
M.,
Hocking,
B.
B.,
Skratt,
J.
C.,
Burns
J.
M.,
and
Mandel,
J.
H.
(
2001b).
"
An
Epidemiologic
Analysis
of
Episodes
of
Care
of3M
Decatur
Chemical
and
Film
Plant
Employees,"
1993­
1998.
St.
Paul
(
MN),
3M
Company.
U.
S.
EPA
Docket
AR­
226­
1030a02;
16)
Olsen,
G.
W.,
Burns,
J.
M.,
Burlew,
M.
M.,
and
Mandel,
J.
H.
(
2003).
"
Epidemiologic
assessment
of
worker
serum
perfluorooctanesulfonate
(
PFOS)
and
perfluorooctanoic
acid
(
PFOA)
concentrations
and
medical
surveillance
examinations."
Journal
of
Occupational
and
Environmental
Medicine,
in
press;

Recent
toxicological
reviews
funded
by
APFO
Users
and
APME:

17)
An
assessment
prepared
forthe
Association
ofPlastics
Manufacturers
in
Europe
and
SPI
entitled
"
Genotoxicity,
Carcinogenicity,
Developmental
Effects
and
Reproductive
Effects
ofPerfluorooctanoate:
A
Perspective
from
Available
Animal
and
Human
Studies,"
December
19,
2002;
and
18)
Environmental
Health
Research
Foundation,
"
Summary
and
Analysis
ofHealth
Data
on
Perfluorooctanoic
Acid
(
PFOA),"
March
5,
2003.
Addendum
III
Manufacture
ofAFFO
Responsible
manufabtuning
ofAPFO
requires
that
the
parties
undertaking
that
manufacture
meet
certain
environmental,
health
and
safety
standards.
Accordingly,
when
manufacturing
APFO
for
a
commercial
use
in
the
United
States,
a
responsible
manufacturer
will
first
notify
EPA,
and
will
review
their
product
stewardship
program
with
EPA
covering
the
provisions
listed
below.
For
purposes
ofthis
addendum,
manufacture
means
to
make
or
produce
for
commercial
use
at
a
facility
in
the
United
States;
importation
ofAPFO
for
use
in
manufacturing
or
processing
fluoropolymers
is
not
included.

1)
Limit
total
annual
emissions
in
the
US
from
each
site
where
manufacturing
of
APFO
occurs,
using
technology
reasonably
available
that
reduces
APFO
emissions
to
less
than
500
pounds
per
year
(
a
99%
reduction
compared
to
prior
manufacturing
technology
as
reported
in
the
documents
contained
in
EPA's
docket);
and
2)
Sell
or
resell
APFO
in
accordance
with
ACC
or
SOCMA
good
product
stewardship
codes;
and
3)
Offer
voluntary
blood
testing
for
employees,
conduct
industrial
hygiene
monitoring
in
the
work
areas
where
APFO
is
made
or
processed,
and,
based
on
the
results,
take
steps
to
control
the
exposures
to
levels
at
least
as
low
as
the
ACGIH
TLV,
by
assuring
that
appropriate
protective
equipment
and
safe
handling
practices
are
used,
and
continue
to
provide
and
update
employee
training
on
safe
handling;
and
4)
Monitor
groundwater
and
surface
water
for
APFO
in
the
vicinity
ofthe
facility,
conduct
air
modeling
studies
based
on
available
technology
for
air
monitoringfbr
APFO
at
the
facility;
maintain
off­
site
exposure
below
the
West
Virginia
screening
levels;
and
5)
Beginning
in
the
year
after
production
commences,
and
continuing
for
five
consecutive
years
following,
for
the
prior
calendar
year,
report
to
EPA
biennially,
on
a
calendar
year
basis
(
unless
otherwise
provided
in
individual
agreements
with
EPA
and
state
regulatory
agencies),
within
180
days
ofthe
end
ofthe
reporting
period,
annual
production
volume
ofAPFO,
their
emissions
per
facility
(
air,
water,
waste),
summary
reports
on
groundwater
and
surface
water
monitoring
results,
workplace
industrial
hygiene
monitoring,
and
summary
data
on
employee
blood
monitoring
results
(
taking
steps
to
preserve
employee
confidentiality).

Page
1
of
1
March
14.
2003