Document ID: EPA-HQ-OPPT-2003-0012-0001
Agency: epa
Document Type: Notice
Title: Perfluorooctanoic Acid (PFOA), Fluorinated Telomers; Request For Comment, Solicitation of Interested Parties for Enforceable Consent Agreement Development, and Notice of Public Meeting
Posted Date: 2003-04-16T04:00Z

18626
Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Notices
categorically
excluded
from
the
preparation
of
an
environmental
assessment
or
an
environmental
impact
statement.

Determination
Under
Executive
Order
12866
Western
has
an
exemption
from
centralized
regulatory
review
under
Executive
Order
12866.
This
notice
is
not
required
to
be
cleared
by
the
Office
of
Management
and
Budget.

Dated:
March
27,
2003.
Michael
S.
Hacskaylo,
Administrator.
[
FR
Doc.
03
 
9325
Filed
4
 
15
 
03;
8:
45
am]

BILLING
CODE
6450
 
01
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0012;
FRL
 
7303
 
8]

Perfluorooctanoic
Acid
(
PFOA),
Fluorinated
Telomers;
Request
for
Comment,
Solicitation
of
Interested
Parties
for
Enforceable
Consent
Agreement
Development,
and
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
EPA
has
identified
potential
human
health
concerns
from
exposure
to
perfluorooctanoic
acid
(
PFOA)
and
its
salts,
although
there
remains
considerable
scientific
uncertainty
regarding
potential
risks.
EPA
is
requesting
public
comment
on
pertinent
topics
of
interest,
as
discussed
in
this
document,
and
the
submission
of
additional
data
concerning
these
chemicals.
EPA
is
also
soliciting
the
identification
of
interested
parties
who
want
to
monitor
or
participate
in
negotiations
on
one
or
more
enforceable
consent
agreements
(
ECAs)
under
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA)
concerning
PFOA
and
fluorinated
telomers
which
may
metabolize
or
degrade
to
PFOA,
and
is
announcing
the
first
public
meeting
for
these
ECA
negotiations.
DATES:
Comments
on
this
notice
must
be
received
on
or
before
May
16,
2003.
Notify
EPA
in
writing
on
or
before
May
16,
2003
of
your
desire
to
be
accorded
``
interested
party''
status
for
the
purpose
of
participating
in
or
monitoring
the
negotiations
for
development
of
ECAs
concerning
PFOA
and
telomers.
A
public
meeting
has
been
scheduled
to
initiate
negotiations
on
an
ECA
for
PFOA
and
telomers,
from
1
p.
m.
to
5
p.
m.,
on
Friday,
June
6,
2003.
ADDRESSES:
Submit
your
comments,
identified
by
docket
ID
number
OPPT
 
2003
 
0012,
online
at
http://
www.
epa.
gov/
edocket/
(
EPA's
preferred
method),
or
by
mail
to
EPA
Docket
Center
(
7407),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
For
additional
comment
submission
methods
and
detailed
instructions,
go
to
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
Submit
your
notification
for
``
interested
party''
status
separately
from
any
comments
submitted,
identified
``
Attention:
PFOA
ECA
Notification''
by
mail
to
Brigitte
Farren,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
To
protect
personal
information
from
disclosure
to
the
public,
please
submit
these
notifications
separately
from
your
comments
and
do
not
use
any
online
electronic
commenting
system
to
submit
this
notification.
The
public
meeting
to
initiate
negotiations
on
ECAs
for
PFOA
and
telomers
will
be
held
at
the
Environmental
Protection
Agency,
EPA
East
Bldg.,
Rm.
1153,
1201
Constitution
Ave.,
NW.,
Washington,
DC.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Mary
Dominiak,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8104;
e­
mail
address:
dominiak.
mary@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
and
may
be
of
particular
interest
to
manufacturers,
importers,
processors,
exporters,
distributors,
and
users
of
PFOA,
fluoropolymers,
fluoroelastomers,
and
telomer
chemicals.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2003
 
0012.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102
 
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
Additional
information
concerning
the
topics
discussed
in
this
notice
can
be
found
in
Administrative
Record
(
AR)
 
226:
PFOS,
PFOA,
Telomers,
and
Related
Chemicals,
which
was
established
by
the
Agency
in
2000
to
receive
information
on
various
fluorinated
chemicals,
including
PFOA.
These
materials
are
also
available
in
the
EPA
Docket
Center.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
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2003­
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0001
RECEIVED
OPPT
NCIC
2003
APR16
7:
28AM
18627
Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Notices
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
(
Please
note,
however,
that
to
protect
personal
information
from
disclosure
to
the
public,
you
should
not
follow
the
instructions
in
this
section
to
submit
your
notification
for
``
interested
party''
status.
Such
notification
should
be
submitted
separately
from
any
comments
on
this
document
using
the
specific
instructions
provided
under
ADDRESSES.
Do
not
use
any
online
electronic
commenting
system
to
submit
this
notification.)
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPPT
 
2003
 
0012.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
oppt.
ncic@
epa.
gov,
Attention:
Docket
ID
Number
OPPT
 
2003
 
0012.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
email
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Document
Control
Office
(
7407M),
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
OPPT
Document
Control
Office
(
DCO)
in
EPA
East
Bldg.,
Rm.
6428,
1201
Constitution
Ave.,
NW.,
Washington,
DC.
Attention:
Docket
ID
Number
OPPT
 
2003
 
0012.
The
DCO
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
DCO
is
(
202)
564
 
8930.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,

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Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Notices
please
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

We
invite
you
to
provide
your
views
on
the
various
options
we
propose,
new
approaches
we
have
not
considered,
the
potential
impacts
of
the
various
options
(
including
possible
unintended
consequences),
and
any
data
or
information
that
you
would
like
the
Agency
to
consider
during
the
development
of
the
final
action.
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
prepared
a
preliminary
risk
assessment
(
Ref.
1)
on
perfluorooctanoic
acid
(
PFOA)
(
Octanoic
acid,
pentadecafluoro­;
Chemical
Abstracts
Service
Registry
Number
(
CAS
No.)
335
 
67
 
1)
and
its
salts,
predominantly
ammonium
perfluorooctanoate
(
APFO)
(
Octanoic
acid,
pentadecafluoro­,
ammonium
salt
(
CAS
No.
3825
 
26
 
1)).
This
preliminary
assessment
indicates
potential
nationwide
human
exposure
to
low
levels
of
PFOA.
Based
on
certain
animal
studies,
there
could
be
a
potential
risk
of
developmental
and
other
adverse
effects
associated
with
these
exposures
in
humans.
However,
this
assessment
also
reflects
substantial
uncertainty
about
the
interpretation
of
the
risk.
EPA
has
identified
areas
where
additional
information
could
be
very
helpful
in
allowing
the
Agency
to
develop
a
more
accurate
assessment
of
the
potential
risks
posed
by
PFOA
and
the
other
compounds
addressed
in
this
notice,
and
to
identify
what
voluntary
or
regulatory
mitigation
or
other
actions,
if
any,
would
be
appropriate.
EPA
is
making
this
preliminary
assessment
public
in
order
to
identify
the
Agency's
concerns,
to
indicate
areas
where
additional
information
or
investigation
would
be
useful,
and
to
request
the
submission
of
data
addressing
these
issues.
EPA
is
also
soliciting
the
identification
of
parties
who
would
be
interested
in
monitoring
or
participating
in
negotiations
for
the
development
of
one
or
more
ECAs
under
section
4
of
TSCA
on
PFOA
and
on
fluorinated
telomers
(
hereafter
``
telomers'')
which
may
metabolize
or
degrade
to
PFOA.
The
intent
of
the
ECAs
would
be
to
develop
additional
information,
particularly
environmental
fate
and
transport
information,
to
enhance
understanding
of
the
sources
of
PFOA
in
the
environment
and
the
pathways
by
which
human
exposure
to
PFOA
is
occurring.

III.
Background
In
1999,
EPA
began
an
investigation
after
receiving
data
on
perfluorooctyl
sulfonate
(
PFOS)
indicating
that
PFOS
was
persistent,
unexpectedly
toxic,
and
bioaccumulative.
These
data
also
showed
that
PFOS
had
been
found
in
very
low
concentrations
in
the
blood
of
the
general
population
and
in
wildlife
around
the
world.
3M
Company
(
3M),
the
sole
manufacturer
of
PFOS
in
the
United
States
and
the
principal
manufacturer
worldwide,
announced
in
May
2000
that
it
was
discontinuing
its
perfluorooctanyl
chemistries,
including
PFOS.
EPA
followed
the
voluntary
3M
phaseout
with
regulatory
action
under
TSCA
section
5
to
limit
any
future
manufacture
or
importation
of
PFOS
before
EPA
has
had
an
opportunity
to
review
activities
and
risks
associated
with
the
proposed
manufacture
or
importation
(
Ref.
2).
In
June
2000,
EPA
indicated
that
it
was
expanding
its
investigation
of
PFOS
to
encompass
other
fluorochemicals,
including
PFOA,
in
order
to
determine
whether
these
other
fluorochemicals
might
present
concerns
similar
to
those
found
with
PFOS.
EPA
was
concerned
in
part
because
3M
had
also
found
PFOA
in
human
blood
during
the
studies
on
PFOS
(
Ref.
3).
In
September
2002,
the
Director
of
OPPT
initiated
a
priority
review
on
PFOA
because
the
developmental
toxicity
data,
the
carcinogenicity
data,
and
the
blood
monitoring
data
presented
in
an
interim
revised
hazard
assessment
raised
the
possibility
that
PFOA
might
meet
the
criteria
for
consideration
under
TSCA
section
4(
f)
(
Refs.
4
and
5).
When
the
priority
review
commenced,
EPA
anticipated
completing
the
review
within
a
few
months.
However,
as
explained
in
this
notice,
there
remain
substantial
uncertainties
associated
with
the
preliminary
risk
assessment.
EPA
believes
these
uncertainties
may
be
reduced
through
acquisition
of
the
information
described
in
this
notice.
EPA
is
therefore
continuing
the
priority
review
in
order
to
acquire
this
information
and
better
inform
the
Agency's
decisionmaking.

A.
PFOA
Sources
and
Uses
PFOA
and
its
salts
are
fully
fluorinated
organic
compounds
that
can
be
produced
synthetically
and
formed
through
the
degradation
or
metabolism
of
certain
other
manmade
fluorochemical
products.
PFOA
is
a
synthetic
chemical
and
is
not
naturally
occurring.
Consequently,
all
PFOA
in
the
environment
is
attributable
to
human
activity.
PFOA
is
used
primarily
to
produce
its
salts,
which
are
used
as
essential
processing
aids
in
the
production
of
fluoropolymers
and
fluoroelastomers.
Although
they
are
made
using
PFOA,
finished
fluoropolymer
and
fluoroelastomer
products
are
not
expected
to
contain
PFOA.
In
recent
years,
less
than
600
metric
tons
per
year
of
PFOA
and
its
salts
have
been
manufactured
or
imported
in
the
United
States
(
Ref.
6).
The
major
fluoropolymers
manufactured
using
PFOA
salts
are
polytetrafluoroethylene
(
PTFE)
and
polyvinylidine
fluoride
(
PVDF).
PTFE
has
hundreds
of
uses
in
many
industrial
and
consumer
products,
including
soil,
stain,
grease,
and
water
resistant
coatings
on
textiles
and
carpet;
uses
in
the
automotive,
mechanical,
aerospace,
chemical,
electrical,
medical,
and
building/
construction
industries;
personal
care
products;
and
non­
stick
coatings
on
cookware.
PVDF
is
used
primarily
in
three
major
industrial
sectors:
Electrical/
electronics,
building/
construction,
and
chemical
processing.
PFOA
can
be
commercially
manufactured
by
two
major
alternative
processes:
The
Simons
Electro­
Chemical
Fluorination
(
ECF)
process,
and
a
telomerization
process.
Releases
from
manufacturing
processes
are
one
source
of
PFOA
in
the
environment.
Historically,
most
U.
S.
production
was
by
3M
using
the
ECF
process.
3M
discontinued
its
manufacture
of
PFOA
between
2000
and
2002,
and
other
domestic
producers
are
using
the
telomerization
process
exclusively.
In
the
ECF
process,
an
electric
current
is
passed
through
a
solution
of
anhydrous
hydrogen
fluoride
and
an
organic
feedstock
of
octanoic
acid
or
a
derivative.
The
ECF
process
replaces
the
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16,
2003
/
Notices
carbon­
hydrogen
bonds
on
molecules
of
the
organic
feedstock
with
carbonfluorine
bonds.
Perfluorination
occurs
when
all
the
carbon­
hydrogen
bonds
are
replaced
with
carbon­
fluorine
ones.
The
ECF
process
yields
between
30
 
45%
straight
chain
(
normal)
perfluorooctanonyl
fluoride
(
PFOF),
along
with
a
variable
mixture
of
byproducts
and
impurities.
The
output
of
the
ECF
process
consists
of
a
complex
combination
of
chemical
substances
with
varying
molecular
weights,
including
higher
and
lower
straightchain
homologues;
branched­
chain
perfluoroalkyl
fluorides
of
various
chain
lengths;
straight­
chain,
branched,
and
cyclic
perfluoroalkanes
and
ethers;
and
other
byproducts.
After
disposal
or
recovery
of
some
of
the
byproducts
and
impurities,
the
acid
fluoride
is
base
hydrolyzed
in
batch
reactors
to
yield
PFOA.
The
PFOA
salts
are
synthesized
by
base
neutralization
of
the
acid
to
the
salt
in
a
separate
reactor.
In
the
telomerization
process,
tetrafluoroethylene
is
reacted
with
other
fluorine­
bearing
chemicals
to
yield
fluorinated
intermediates
which
are
readily
converted
into
PFOA.
This
process
yields
predominantly
straightchain
acids
with
an
even
number
of
carbon
atoms.
Distillation
can
be
used
to
obtain
pure
components.
Commercial
products
manufactured
through
the
telomerization
process,
sometimes
known
as
telomers,
are
generally
mixtures
of
perfluorinated
compounds
with
even
carbon
numbers,
although
the
process
can
also
produce
compounds
with
odd
carbon
numbers.
In
addition
to
releases
from
the
deliberate
manufacture
of
PFOA
through
either
the
ECF
or
telomerization
processes,
and
from
the
use
of
PFOA
and
its
salts
in
the
manufacture
and
processing
of
fluoropolymers
and
fluoroelastomers,
PFOA
may
have
entered
the
environment
through
other
sources.
3M
has
indicated
that
PFOA
may
have
been
present
as
a
trace
contaminant
in
some
of
the
fluorochemical
products
which
it
discontinued
manufacturing
between
2000
and
2002
(
Ref.
7).
Because
these
products
are
no
longer
being
manufactured,
they
will
likely
not
be
a
significant
potential
future
source
of
PFOA.
EPA
has
also
received
data
which
indicate
that
the
8
 
2
telomer
alcohol
(
1­
Decanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10­
heptadecafluoro­
(
CAS
No.
678
 
39
 
7))
although
not
itself
made
with
PFOA,
can
be
metabolized
by
living
organisms
or
biodegrade
under
environmental
conditions
to
produce
PFOA
(
Refs.
8
and
9).
Other
telomer
chemicals
have
not
been
tested
to
determine
whether
they
may
also
metabolize
or
degrade
to
form
PFOA.
Telomers
are
used
widely
in
a
range
of
commercial
products,
including
some
that
are
directly
released
into
the
environment,
such
as
fire
fighting
foams,
as
well
as
soil,
stain,
and
grease
resistant
coatings
on
carpets,
textiles,
paper,
and
leather.
The
extent
to
which
these
telomer­
containing
products
might
degrade
to
release
PFOA
is
unknown.
However,
anecdotal
evidence
of
the
atmospheric
presence
of
telomer
alcohols
in
a
multi­
city
North
American
survey
suggests
that
telomers
may
be
one
source
of
environmental
PFOA
(
Ref.
10).
Additional
fate
information
is
necessary
to
determine
whether
and
the
extent
to
which
telomer
product
degradation
may
be
a
source
of
PFOA.
EPA
is
not
currently
aware
of
any
other
potential
sources
of
PFOA
in
the
environment.
EPA
specifically
requests
comment
on
this
issue,
and
the
submission
of
any
data
identifying
or
characterizing
PFOA
sources.
EPA
is
especially
interested
in
the
thermal
stability
and
oxidative
degradation
products
of
materials
containing
PFOA
or
telomer
chemicals
which
are
incinerated.

B.
Hazard
and
Exposure
EPA
has
conducted
a
detailed
review
of
all
available
hazard
and
exposure
information
on
PFOA.
This
review
is
available
in
the
Agency's
Revised
Draft
Hazard
Assessment
on
PFOA
and
Its
Salts
(
Ref.
11).
This
draft
hazard
assessment
has
not
been
formally
peer
reviewed,
but
has
been
reviewed
internally
by
the
EPA
Office
of
Research
and
Development
(
ORD).
PFOA
is
persistent
in
the
environment.
It
does
not
hydrolyze,
photolyze,
or
biodegrade
under
environmental
conditions.
Based
on
recent
human
biomonitoring
data
provided
by
industry,
which
found
PFOA
in
the
blood
of
workers
and
the
general
population
in
all
geographic
regions
of
the
United
States,
exposure
to
PFOA
is
potentially
nationwide,
although
the
routes
of
exposure
for
the
general
population
are
unknown.
Several
epidemiological
studies
on
the
effects
of
PFOA
in
humans
have
been
conducted
on
workers.
An
association
with
PFOA
exposure
and
prostate
cancer
was
reported
in
one
study;
however,
this
result
was
not
observed
in
an
update
to
the
study
in
which
the
exposure
categories
were
modified.
A
non­
statistically
significant
increase
in
the
levels
of
the
hormone
estradiol
in
workers
with
high
serum
PFOA
levels
(>
30
parts
per
million
(
ppm))
was
also
reported,
but
none
of
the
other
hormone
levels
analyzed
indicated
any
adverse
effects.
APFO
is
the
most
widely
used
salt
of
PFOA,
and
most
animal
toxicity
studies
have
been
conducted
with
APFO.
An
extensive
array
of
animal
toxicity
studies
have
been
conducted
in
rodents
and
monkeys.
These
studies
have
shown
that
APFO
exposure
can
result
in
a
variety
of
toxic
effects
in
animals
including
liver
toxicity,
developmental
toxicity,
and
immunotoxicity.
In
addition,
rodent
bioassays
have
shown
that
chronic
APFO
exposure
is
associated
with
a
variety
of
tumor
types.
The
mechanisms
of
APFO
tumorigenesis
are
not
clearly
understood.
At
this
time,
EPA
is
evaluating
the
scientific
evidence
and
has
not
reached
any
conclusions
on
the
potential
significance
to
humans
of
the
rodent
cancer
data.
There
are
marked
gender
differences
in
the
elimination
of
PFOA
in
rats.
In
addition,
there
are
substantial
differences
in
the
half­
life
of
PFOA
in
rats,
monkeys,
and
humans.
The
gender
and
species
differences
are
not
completely
understood
and
therefore
the
extent
of
potential
risks
to
humans
is
uncertain.

C.
Preliminary
Risk
Assessment
Because
TSCA
section
4(
f)
is
focused
narrowly
on
the
specific
toxicity
endpoints
of
cancer,
birth
defects,
and
gene
mutation,
the
preliminary
risk
assessment
prepared
as
part
of
this
priority
review
focused
on
the
potential
risks
for
developmental
toxicity
in
humans.
EPA
did
not
include
cancer
risk
in
this
preliminary
assessment
due
to
questions
concerning
the
potential
significance
to
humans
of
the
rodent
cancer
data.
Because
data
indicate
that
PFOA
is
not
mutagenic,
concern
for
gene
mutation
was
not
an
issue
for
this
preliminary
assessment.
The
preliminary
risk
assessment
used
a
margin
of
exposure
(
MOE)
approach
(
Ref.
1).
For
many
risk
assessments,
the
MOE
is
calculated
as
the
ratio
of
the
administered
dose
from
the
animal
toxicology
study
to
the
estimated
human
exposure
level.
The
human
exposure
is
estimated
from
a
variety
of
potential
exposure
scenarios,
each
of
which
requires
a
variety
of
assumptions.
A
more
accurate
estimate
of
the
MOE
can
be
derived
if
measures
of
internal
dose
are
available
for
humans
and
the
animal
model.
In
this
preliminary
risk
assessment,
serum
levels
of
PFOA,
which
are
a
measure
of
internal
dose,
were
available
for
some
administered
dose
levels
in
the
rat
2­
generation
reproductive
toxicology
study
and
from
human
biomonitoring
studies.
Thus,
internal
dose
was
used
for
the
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Notices
calculation
of
MOEs
in
this
assessment.
The
actual
values
of
the
MOEs
derived
must
be
viewed
with
caution,
however,
due
to
the
differences
in
kinetics
between
humans
and
rodents.
The
range
of
MOEs
in
the
preliminary
assessment
encompasses
some
values
that
would
indicate
potential
concern
and
other
values
that
would
indicate
a
low
level
of
concern.
Due
to
the
uncertainties
in
the
assessment,
and
the
possibility
that
the
additional
information
discussed
in
this
notice
might
reduce
those
uncertainties,
the
Agency
has
not
attempted
further
interpretation
of
these
MOEs
at
this
time.
The
interpretation
of
the
significance
of
the
MOEs
for
ascertaining
potential
levels
of
concern
will
necessitate
a
better
understanding
of
the
appropriate
dose
metric
in
rats,
and
the
relationship
of
the
dose
metric
to
the
human
serum
levels.
As
this
priority
review
of
PFOA
progresses,
EPA
will
continue
to
develop
the
characterization
of
hazard
and
potential
risk
associated
with
exposure
to
PFOA.
Because
the
scientific
interpretation
issues
in
this
case
are
particularly
complex,
given
the
unusual
properties
and
behavior
of
PFOA
and
the
absence
of
data
on
exposure
pathways
and
levels,
EPA
anticipates
that
a
more
comprehensive
risk
analysis
will
be
taken
to
the
Agency's
Science
Advisory
Board
for
review
and
comment
in
fall
2003.
The
preliminary
risk
assessment
described
in
this
notice
has
not
been
formally
peer
reviewed,
but
has
gone
through
internal
review
by
multiple
EPA
offices,
including
ORD,
the
Office
of
Science
Coordination
and
Policy
(
OSCP),
the
Office
of
Pesticide
Programs
(
OPP),
and
the
Office
of
Policy,
Economics,
and
Innovation
(
OPEI).
The
preliminary
risk
assessment
has
also
been
the
subject
of
an
external
letter
peer
review.

D.
Uncertainties
and
Data
Needs
Although
EPA
has
concerns
with
respect
to
the
potential
nationwide
presence
of
PFOA
in
blood
and
with
the
potential
for
developmental
and
other
effects
suggested
by
animal
studies,
there
are
significant
uncertainties
in
the
Agency's
quantitative
assessment
of
the
risks
of
PFOA.
In
addition,
the
uncertainties
discussed
in
this
unit
with
respect
to
the
identification
of
the
pathway
or
pathways
that
result
in
human
exposure
to
PFOA
(
air,
water,
food,
etc.),
and
the
uncertainties
associated
with
how
PFOA
gets
into
those
pathways
(
including
the
products
or
processes
that
are
responsible
for
the
presence
of
PFOA
in
the
environment)
make
it
difficult
to
determine
what,
if
any,
particular
risk
mitigation
measures
would
be
appropriate.
The
Agency
believes
that
the
additional
information
identified
in
this
notice
would
better
inform
this
priority
review
and
Agency
decisionmaking
with
respect
to
PFOA.
The
sources
of
PFOA
in
the
environment,
as
described
in
Unit
II.
A.,
are
not
fully
defined
or
understood.
Historically,
direct
PFOA
releases
during
the
manufacture
of
PFOA
and
its
use
in
the
manufacture
and
processing
of
fluoropolymers
and
fluoroelastomers
have
been
quantified
at
some
sites.
Industry
has
identified
and
implemented
voluntary
control
technologies
to
reduce
releases,
as
well
as
to
improve
PFOA
recovery
for
recycling
or
destruction,
as
described
in
Unit
II.
E.
The
effectiveness
of
these
programs
could
be
assessed,
possibly
through
the
ECA
process
described
in
Unit
V.,
by
monitoring
PFOA
levels
at
the
respective
facilities
and
determining
if
the
release
reduction
and
waste
management
programs
are
reducing
the
PFOA
levels
in
the
media
surrounding
the
affected
facilities.
PFOA
exposures
and
releases
to
the
environment
may
also
come
from
the
distribution
of
PFOA
in
aqueous
dispersions
of
fluoropolymers
used
by
processors
to
apply
coatings
to
metals
and
textiles,
a
topic
which
industry
is
also
attempting
to
resolve.
In
addition,
the
question
of
the
potential
contribution
to
PFOA
levels
from
telomer
manufacture
and
from
telomer
product
degradation
remains.
The
universe
of
specific
telomer
chemicals
that
may
ultimately
degrade
or
metabolize
to
PFOA
has
not
been
fully
defined.
Preliminary
data
suggest
that
only
higher
perfluorinated
homologues
(
chemicals
with
carbon
chain
lengths
of
eight
and
higher)
would
be
converted
into
PFOA
via
normal
environmental
pathways.
The
8
 
2
telomer
alcohol
has
been
shown
to
biodegrade
and
metabolize
to
form
PFOA,
but
other
telomer
chemicals,
including
telomer
iodides
and
telomerderived
polymers,
have
not
yet
been
tested.
Determining
possible
telomer
product
sources
of
PFOA
may
be
particularly
difficult
because
these
fluorochemicals
are
typically
used
in
products
in
very
low
concentrations,
indicating
that
any
individual
source
contribution
by
specific
products
could
be
very
small,
widely
distributed,
and
difficult
to
detect.
For
example,
products
contaminated
with
volatile,
unreacted
telomer
alcohol
residuals
could
potentially
release
those
residuals
into
the
environment
where
they
could
be
subject
to
biodegradation.
The
exposure
routes
leading
to
the
presence
of
PFOA
in
human
blood
are
not
known.
The
nationwide
presence
of
PFOA
in
human
blood,
contrasted
with
the
limited
geographic
locations
of
fluorochemical
plants
making
or
using
the
chemical,
suggests
that
there
must
be
additional
sources
of
PFOA
in
the
environment,
and
exposures
beyond
those
attributable
to
direct
releases
from
industrial
facilities.
But
whether
these
exposures
are
due
to
PFOA
in
the
air,
the
water,
on
dusts
or
sediments,
in
dietary
sources,
or
through
some
combination
of
routes
is
currently
unknown.
Data
evaluating
the
environmental
presence
of
PFOA
in
water
are
very
limited
and
site­
specific.
Data
on
the
presence
of
PFOA
in
air
or
soil
are
not
currently
available.
Data
on
the
presence
of
PFOA
in
wildlife
suggest
that
animals
are
not
as
likely
as
humans
to
have
PFOA
in
their
blood,
and
that
PFOA
is
not
found
as
widely
in
animals
as
PFOS.
Whether
these
differences
may
be
due
to
different
exposure
pathways
or
to
differences
in
how
the
chemicals
are
processed
or
retained
by
animals
and
humans
is
unknown.
The
technical
difficulties
of
detecting
and
accurately
measuring
the
chemical
in
all
these
various
media,
particularly
in
the
low
concentrations
that
EPA
would
anticipate,
are
considerable.
The
preliminary
risk
assessment
on
potential
developmental
toxicity
was
based
on
a
comparison
of
serum
levels
in
the
2­
generation
rat
reproductive
study
with
those
found
in
the
human
population.
However,
there
are
considerable
species
differences
in
the
kinetics
of
PFOA.
Interpretation
of
the
significance
of
the
MOEs
for
ascertaining
potential
levels
of
concern
will
necessitate
a
better
understanding
of
the
appropriate
dose
metric
in
rats,
and
the
relationship
of
the
dose
metric
to
the
human
serum
levels.
Finally,
there
are
some
uncertainties
regarding
the
use
of
the
human
biomonitoring
data.
Although
the
available
data
include
a
range
of
populations
with
various
demographics
in
many
States
and
all
geographic
areas
of
the
country,
there
may
be
some
populations
that
are
not
represented.
Because
it
is
unknown
how
the
human
exposures
are
occurring,
proximity
to
a
manufacturing
facility
may
or
may
not
be
a
factor
in
exposure.
However,
populations
living
near
these
facilities
were
not
sampled.
Therefore,
it
is
possible
that
PFOA
serum
levels
may
be
underestimated
for
certain
portions
of
the
U.
S.
population.
The
children's
sample
was
derived
from
blood
collected
in
1994/
1995;
therefore,
it
may
not
reflect
the
current
status
of
PFOA
in
children's
blood.
Voluntary
activities
by
industry
are
underway
as
described
in
Unit
II.
E.
to
help
address
some
of
these
uncertainties
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Notices
and
data
gaps.
For
example,
pharmacokinetics
studies
examining
the
biological
processing
of
PFOA
in
rats
are
expected
to
be
completed
in
the
summer
and
fall
of
2003.
These
studies
may
help
to
reduce
the
uncertainty
in
the
estimation
of
risk
to
humans.
In
addition,
EPA
has
submitted
a
nomination
to
the
Centers
for
Disease
Control
and
Prevention
(
CDC)
to
include
PFOS,
PFOA,
and
certain
related
fluorochemicals
in
the
next
National
Health
and
Nutrition
Examination
Survey
(
NHANES).
This
would
provide
a
national
baseline
of
PFOA
exposure,
both
to
indicate
whether
current
data
are
representative
of
the
U.
S.
population
and
to
offer
a
gauge
with
which
to
measure
the
effectiveness
of
actions
to
reduce
exposures.
EPA
will
continue
to
develop
and
clarify
issues
relating
to
hazard,
exposure,
and
risk
as
the
priority
review
continues
and
the
Agency
receives
additional
information
that
allows
further
resolution
of
the
uncertainties
identified
in
this
unit.
Additional
data
beyond
EPA's
current
activities
and
the
voluntary
efforts
undertaken
by
the
industry
may
be
necessary
to
resolve
the
existing
uncertainties
and
fill
remaining
data
gaps,
including
gaps
not
yet
identified.
EPA
requests
comment
on
these
issues,
and
particularly
requests
that
comments
include
the
submission
of
any
additional
data
that
may
help
to
fill
these
gaps.
Certain
specific
information
requests
are
identified
in
Unit
IV.

E.
Ongoing
Voluntary
Activities
In
2000,
EPA
opened
a
non­
regulatory
public
docket
file,
Administrative
Record
AR
 
226,
for
information
on
PFOS,
PFOA,
telomers,
and
related
fluorinated
chemicals,
and
began
to
express
its
concerns
to
the
global
fluorochemical
industry
(
Ref.
3).
In
response,
the
industry
began
providing
information
to
the
Agency,
all
of
which
has
been
placed
into
AR
 
226.
Two
industry
groups,
the
Fluoropolymer
Manufacturing
Group
(
FMG)
and
the
Telomer
Research
Program
(
TRP),
formed
and
began
pursuing
voluntary
collective
actions
to
address
issues
associated
with
PFOA
and
the
telomers.
3M
continued
its
ongoing
research
efforts
despite
having
discontinued
the
manufacture
of
both
PFOS
and
PFOA.
Much
of
the
information
reflected
in
the
EPA's
revised
draft
hazard
assessment
and
preliminary
risk
assessment
on
PFOA
was
provided
through
these
voluntary
activities
on
the
part
of
industry.
In
March
2003,
EPA
received
letters
from
3M,
FMG,
and
TRP
documenting
their
ongoing
voluntary
programs
and
outlining
their
plans
for
continuing
research
and
product
stewardship
activities
(
Refs.
7,
12,
and
13).
These
letters
have
been
placed
in
the
public
docket
for
this
notice
and
can
be
accessed
as
described
in
Unit
I.
B.
2.
The
letters
contain
substantial
additional
information
concerning
the
specifics
of
the
voluntary
industry
actions
beyond
what
is
presented
in
this
notice.
In
its
letter,
3M
indicated
that
it
would
not
resume
the
manufacture
of
PFOA
for
commercial
sale;
that
it
would
continue
its
medical
monitoring
efforts
for
workers
and
provide
biannual
reports
to
EPA
and
update
its
epidemiological
study
reports
to
EPA
every
5
years;
and
that
it
will
continue
monitoring
groundwater,
surface
water,
and
other
environmental
media
and
provide
a
summary
report
to
EPA
within
2
years.
3M
also
stated
that
it
would
work
with
other
members
of
industry
to
conduct
additional
validation
of
PFOA
analytical
methods
and
sampling
protocols
and
to
participate
in
human
health
and
environmental
fate
and
effects
studies
of
PFOA.
3M
also
indicated
that
the
facilities
and
employees
of
its
subsidiary,
Dyneon
LLC,
would
continue
to
be
part
of
the
3M
monitoring
program.
The
members
of
the
FMG
 
Asahi
Glass
Fluoropolymers
USA,
Inc.;
Daikin
America,
Inc.;
E.
I.
duPont
de
Nemours
&
Company;
and
Dyneon
LLC
 
indicated
that
they
and
their
parent
companies
represent
most
of
the
known
use
of
APFO
for
the
production
of
fluoropolymers
both
in
the
United
States
and
worldwide.
Their
letter
includes
commitments
to
reduce
emissions
of
APFO
from
fluoropolymer
and
APFO
manufacturing
facilities
on
a
global,
individual
company­
wide
basis
by
a
minimum
of
50%
by
2006;
to
conduct
studies
on
both
finished
polymers
and
finished
products
from
these
polymers
to
determine
if
any
exposure
to
the
general
population
can
be
related
to
the
fluoropolymer
industry;
to
conduct
studies
on
emissions
from
fluoropolymer
processing
facilities
to
determine
the
level
of
current
emissions;
and
to
develop
additional
toxicological
data
on
APFO.
The
companies
noted
that
they
are
participating
in
activities
through
the
Association
of
Plastics
Manufacturers
in
Europe
(
APME)
to
conduct
pharmacokinetics
studies
in
rats
and
develop
a
pharmacokinetic
model,
and
would
share
those
data
with
EPA
as
they
are
developed,
beginning
in
spring
2003.
The
companies
indicated
that
they
would
continue
to
follow
principles
of
product
stewardship
similar
to
those
described
in
the
Responsible
Care
 
programs
of
the
American
Chemistry
Council
and
the
Synthetic
Organic
Chemical
Manufacturers
Association
in
their
efforts
to
support
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.
The
companies
stated
that
they
will
continue
to
use
appropriate
criteria,
including
such
standards
as
the
interim
air
and
water
screening
levels
and
water
quality
guidelines
recently
adopted
in
West
Virginia,
to
evaluate
operations
and
emissions
(
Refs.
14
and
15).
The
letter
includes
a
schedule
for
the
completion
of
various
studies
already
underway.
The
members
of
the
TRP
 
AGA
Chemicals
(
Asahi
Glass);
Clariant
GmbH;
Daikin
America,
Inc.;
and
E.
I.
duPont
de
Nemours
&
Company
 
indicated
that
they
comprise
the
major
telomer
producers,
and
that
they
are
evaluating
telomer
products
sold
in
the
United
States
to
determine
whether
they
contribute
to
significant
human
or
environmental
exposure
to
PFOA.
They
noted
that
their
evaluation
has
six
key
components:
Analysis
of
products
and
articles;
analysis
of
``
aged''
products
and
``
in
use''
articles;
characterization
of
potential
release
of
PFOA
from
telomerbased
product
manufacture;
characterization
of
potential
release
of
PFOA
from
telomer­
treated
article
manufacture;
analysis
of
possible
biodegradation
of
telomer­
based
polymeric
products;
and
evaluation
of
the
ultimate
fate
and
disposal
routes
for
telomer­
treated
articles
in
the
United
States.
The
letter
includes
lists
and
schedules
for
these
various
evaluation
components,
as
well
as
for
the
submission
of
additional
information
to
the
Agency.
EPA
appreciates
the
industry
response
to
the
Agency's
concerns
regarding
PFOA
and
the
telomers,
and
looks
forward
to
continued
cooperation
on
assessment
and
management
activities.
EPA
invites
the
participation
of
additional
interested
persons
in
these
efforts.
EPA
considers
that
the
timely
submission
of
the
information
which
industry
has
already
committed
to
provide
will
be
essential
to
developing
a
better
and
more
complete
understanding
of
the
potential
risks
of
PFOA.
However,
in
light
of
the
concerns
identified
to
date,
the
Agency
will
continue
its
ongoing
expeditious
review.
While
the
voluntary
industry
activities
as
described
in
the
letters
will
provide
substantial
additional
information,
EPA
considers
it
likely
that
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2003
/
Notices
issues
will
remain
even
after
these
activities
are
complete,
and
that
the
results
of
some
of
these
programs
may
well
identify
additional
questions
that
will
need
to
be
answered.
EPA
requests
comment
on
these
issues.

IV.
Specific
Requests
for
Comments,
Data,
and
Information
EPA
specifically
requests
comments,
data,
and
information
on
the
following
topics.

A.
Use
and
Production
Volume
Information
What
are
the
specific
chemical
identities
(
by
Ninth
Collective
Index
name
and
CAS
No.,
if
available)
of
the
telomer
chemicals,
including
polymers
derived
from
these
telomers,
and
of
the
fluoropolymers
and
fluoroelastomers
made
with
PFOA
or
related
chemicals,
currently
in
commerce?
In
what
volumes
and
at
what
locations
are
these
chemicals
manufactured
or
imported?
How
and
in
what
volumes
are
these
chemicals
used?
What
are
the
benefits
of
these
chemicals
and
products
in
their
specific
uses,
and
what
alternatives
to
these
chemicals
may
be
available
for
specific
uses?

B.
Exposure
Information
How
are
products
containing
the
chemicals
identified
in
Unit
IV.
A.
used?
How
are
these
products
disposed
of?
What
environmental
releases
occur
at
manufacturing
and
processing
facilities
where
these
chemicals
are
used?
What
data
are
available
on
worker
exposures
to
these
chemicals?
What
data
are
available
on
exposures
to
the
general
population?
What
data
are
available
on
measured
levels
of
these
chemicals
in
humans
and
the
environment,
in
all
environmental
media?
What
data
are
available
on
the
biodegradation
of
these
chemicals,
on
releases
of
these
chemicals
from
consumer
and
industrial
products,
and
on
their
breakdown
during
product
biodegradation,
incineration,
and
other
disposal
practices?

C.
Monitoring
and
Related
Information
EPA
specifically
requests
that
any
persons
who
have
in
their
possession
existing
human
or
environmental
monitoring
data
indicating
or
assessing
the
presence
of
PFOA
and
related
fluorochemicals
in
humans,
in
wildlife,
or
in
any
environmental
media,
including
studies
conducted
in
other
countries,
provide
those
data
to
the
Agency
in
response
to
the
publication
of
this
notice
to
enhance
the
understanding
of
PFOA
presence
in
the
environment
and
of
the
pathways
leading
to
exposures.
EPA
includes
in
this
request
any
existing
data
not
otherwise
provided
to
EPA
concerning
the
toxicity,
pharmacokinetics,
and
halflife
of
PFOA
in
organisms.

D.
Additional
Data
Are
there
other
pieces
of
information
not
addressed
in
Unit
IV.
A.,
B.,
and
C.,
that
would
help
EPA
more
accurately
assess
the
risks
of
these
chemicals
and
determine
appropriate
further
action,
if
warranted?

V.
Enforceable
Consent
Agreement
Development
EPA
is
interested
in
developing
one
or
more
ECAs
under
TSCA
section
4
and
40
CFR
part
790
for
PFOA
and
telomers
that
focus
on
identifying
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.
The
objective
of
the
ECA
process
is
to
conclude
one
or
more
ECAs
that
will
set
in
place
an
industrysponsored
testing
program
that
will
address
a
number
of
EPA's
current
data
needs
for
PFOA
and
telomers.
EPA
expects
that
industry
will
meet
the
voluntary
testing
commitments
made
in
their
letters
of
intent,
as
discussed
in
Unit
III.
E.
Therefore,
EPA
anticipates
that
the
ECA
process
will
focus
generally
on
testing
issues
beyond
or
supplemental
to
those
contained
in
the
industry
letters
of
intent.

A.
Solicitation
of
Interested
Parties
EPA
is
soliciting
interested
parties
to
monitor
or
participate
in
negotiations
on
ECAs
for
PFOA
and
telomers.
As
discussed
in
Unit
III.
E.,
3M;
AGA
Chemicals;
Asahi
Glass
Fluoropolymers
USA,
Inc.;
Clariant
GmbH;
Daikin
America,
Inc.;
Dyneon
LLC;
and
E.
I.
duPont
de
Nemours
&
Company,
have
been
pursuing
voluntary
collective
actions
to
address
issues
associated
with
PFOA
and
telomers
and
have
been
keeping
EPA
informed
of
these
activities.
Any
person
who
desires
treatment
as
an
``
interested
party''
during
the
development
of
the
ECAs
must
respond
in
writing
to
this
notice
on
or
before
May
16,
2003
following
the
instructions
in
Unit
I.,
and
must
specifically
request
that
they
be
given
``
interested
party''
status.
These
interested
parties
will
not
incur
any
obligations
by
being
so
designated.
Negotiations
will
be
conducted
in
one
or
more
meetings,
all
of
which
will
be
open
to
the
public.
EPA
will
contact
all
interested
parties
who
have
expressed
a
desire
to
participate
in
or
monitor
the
ECA
negotiations
and
advise
them
of
all
meeting
dates.
EPA
will
also
notify
the
public
of
such
meeting
dates
in
the
electronic
public
docket
for
this
action.
The
negotiation
time
schedule
for
PFOA
and
telomers
will
be
established
at
the
first
negotiation
meeting.
It
is
EPA's
current
intent
to
move
quickly
to
attempt
to
finalize
any
ECAs,
if
possible.
If
an
ECA
is
not
established
in
principle
within
a
reasonable
time­
frame,
negotiations
will
be
terminated,
and
any
unmet
data
needs
may
be
pursued
via
a
test
rule
promulgated
under
TSCA
section
4.
If
the
data
generated
from
the
ECA
do
not
meet
the
Agency's
needs,
EPA
reserves
the
right
to
proceed
with
rulemaking
to
obtain
the
needed
data.
EPA
also
reserves
the
right
to
announce
and
convene
subsequent
ECA
negotiations
for
additional
data,
if
the
testing
from
voluntary
activities,
the
initial
ECA,
or
from
a
test
rule
identify
additional
data
gaps
which
must
be
filled.

B.
ECA
Process
and
Public
Participation
in
Negotiations
EPA
will
provide
the
public
with
an
opportunity
to
comment
on
and
participate
in
the
development
of
any
ECAs
on
PFOA
and
telomers
to
ensure
that
the
views
of
interested
parties
are
taken
into
account
during
the
ECA
process.
This
process
is
described
generally
in
this
unit,
and
is
more
fully
addressed
in
40
CFR
part
790.
Individuals
and
groups
who
respond
to
this
notice
by
May
16,
2003
and
request
treatment
as
interested
parties
will
have
the
status
of
interested
parties.
All
negotiating
meetings
for
the
development
of
this
ECA
will
be
open
to
the
public
and
minutes
of
each
meeting
will
be
prepared
by
EPA
and
placed
in
the
official
public
docket
for
this
action.
The
Agency
will
advise
interested
parties
and
the
public
of
meeting
dates
and
make
available
meeting
minutes,
testing
proposals,
background
documents,
and
other
relevant
materials
exchanged
at
or
prepared
for
negotiating
meetings.
Where
tentative
agreement
is
reached
on
an
acceptable
testing
program,
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
ECA
are
appropriate.
EPA
will
not
reimburse
costs
incurred
by
non­
EPA
participants
in
this
ECA
negotiation
process.
Enforceable
consent
agreements
will
only
be
concluded
where
an
agreement
can
be
obtained,
which
is
satisfactory
to
the
Agency,
manufacturers
or
processors
who
are
potential
test
sponsors,
and
other
interested
parties,
concerning
the
need
for
and
scope
of
testing.
In
the
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Federal
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/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Notices
absence
of
an
ECA,
EPA
reserves
the
right
to
proceed
with
rulemaking.
More
specifically,
EPA
will
not
enter
into
an
ECA
if
either
the
Agency
and
affected
manufacturers
or
processors
cannot
reach
an
agreement
on
the
provisions
of
the
ECA,
or
the
draft
ECA
is
considered
inadequate
by
other
interested
parties
who
have
submitted
timely
objections
to
the
draft
ECA.
However,
EPA
may
reject
these
objections
if
the
Agency
concludes
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
ECA
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
ECA
is
considered
objectionable.
EPA
will
prepare
an
explanation
of
the
basis
for
each
ECA.
That
document
will
summarize
the
agreement
(
including
the
needed
data
development),
explain
the
objectives
of
the
data
collection/
development
activity,
and
outline
the
chemicals'
use
and
exposure
characteristics.
That
document,
which
will
also
announce
the
availability
of
the
final
ECA,
will
be
published
in
the
Federal
Register.
Upon
the
successful
completion
of
an
ECA,
export
notification
under
TSCA
section
12(
b)
would
be
required
for
all
signatories
to
the
ECA
who
export
or
intend
to
export
the
chemicals
subject
to
the
ECA.
A
separate
action
would
be
published
in
the
Federal
Register
following
the
announcement
of
the
ECA
to
apply
the
export
notification
requirement
to
others
by
adding
the
ECA
chemicals
to
the
list
of
chemicals
subject
to
testing
consent
orders
at
40
CFR
799.5000.

VI.
References
These
references
have
been
placed
in
the
official
docket
that
was
established
under
docket
ID
number
OPPT
 
2003
 
0012
for
this
action
as
indicated
in
Unit
I.
B.
2.
Reference
documents
identified
with
an
Administrative
Record
number
(
AR226
 
XXXX)
are
available
in
the
public
version
of
the
official
docket
maintained
in
the
OPPT
Docket.
Copies
of
these
documents
may
be
obtained
as
described
in
Unit
I.
B.
2.
1.
USEPA.
Preliminary
Risk
Assessment
of
the
Developmental
Toxicity
Associated
with
Exposure
to
Perfluorooctanoic
Acid
(
PFOA)
and
its
Salts.
OPPT,
Risk
Assessment
Division.
Washington,
DC.
April
10,
2003.
2.
Federal
Register.
(
65
FR
62319,
October
18,
2000)
(
FRL
 
6745
 
5);
(
67
FR
11008;
March
11,
2002)
(
FRL
 
6823
 
6);
(
67
FR
11014,
March
11,
2002)
(
FRL
 
6823
 
7);
(
67
FR
72854,
December
9,
2002)
(
FRL
 
7279
 
1).
3.
(
AR226
 
0639)
PFOS
Presentation
to
CMA.
Auer,
Charles
M.,
USEPA.
Washington,
DC.
June
19,
2000.
4.
(
AR226
 
1127)
Revision
of
PFOA
Hazard
Assessment
and
Next
Steps.
Memorandum
from
Charles
M.
Auer
to
Oscar
Hernandez,
Mary
Ellen
Weber,
and
Ward
Penberthy.
USEPA.
Washington,
DC.
September
27,
2002.
5.
Section
4(
f)
of
TSCA
(
15
U.
S.
C.
2603
(
4)).
6.
(
AR226
 
0620)
Sulfonated
Perfluorochemicals
in
the
Environment:
Sources,
Dispersion,
Fate,
and
Effects.
3M.
St.
Paul,
MN.
March
1,
2000.
7.
Environmental,
Health
And
Safety
Measures
Relating
to
Perfluorooctanoic
Acid
and
Its
Salts
(
PFOA).
Letter
from
Dr.
Larry
Wendling,
3M,
to
Stephen
L.
Johnson,
USEPA.
3M.
St.
Paul,
MN.
March
13,
2003.
8.
Characterization
of
Fluorinated
Metabolites
by
a
Gas
Chromatographic­
Helium
Microwave
Plasma
Detector;
The
Biotransformation
of
1H,
1H,
2H,
2H­
Perfluorodecanol
to
Perfluorooctanoate.
Hagen,
Donald
F.;
Belisle,
John;
Johnson,
James
D.;
and
Venkateswarlu,
P.
Analytical
Biochemistry.
118,
336
 
343
(
1981).
9.
(
AR226
 
1149).
Revision
1,
Biodegradation
Screen
Study
for
Telomer­
Type
Alcohols.
Lange,
Cleston
C.
Pace
Analytical
Services,
Minneapolis,
MN.
November
6,
2002.
10.
Mabury,
Scott.
Annual
Report
of
Activities
for
Telomer
Research
Program
Grant
to
University
of
Toronto.
University
of
Toronto,
Toronto,
Canada.
September
2002.
11.
(
AR226
 
1136)
Revised
Draft
Hazard
Assessment
of
Perfluorooctanoic
Acid
and
Its
Salts.
USEPA,
OPPT,
Risk
Assessment
Division.
Washington,
DC.
November
4,
2002.
12.
Voluntary
Actions
to
Evaluate
and
Control
Emissions
of
Ammonium
Perfluorooctanoate
(
APFO).
Letter
from
Charles
D.
Allen,
Asahi
Glass
Fluoropolymers
USA,
Inc.;
Takahiko
Sakanoue,
Daikin
America,
Inc.;
James
E.
Gregory,
Dyneon
LLC.;
and
Richard
J.
Angiullo,
E.
I.
duPont
de
Nemours
&
Company,
to
Stephen
L.
Johnson,
USEPA.
March
14,
2003.
13.
Letter
of
Intent
for
the
Telomer
Research
Program
from
H.
Okuno,
AGA
Chemicals,
Inc.;
Hans
Ludwig
Panke
and
Reinhard
Jung,
Clariant
GmbH;
Takahiko
Sakanoue,
Daikin
America,
Inc.;
and
Stephen
H.
Korzeniowski,
E.
I.
duPont
de
Nemours
&
Company,
to
Stephen
L.
Johnson,
USEPA.
March
14,
2003.
14.
Order
on
Consent
between
E.
I.
duPont
de
Nemours
&
Company
and
USEPA,
Region
III
and
Region
V.
Philadelphia,
PA.
March
12,
2002.
15.
West
Virginia
Department
of
Environmental
Protection.
Final
Ammonium
Perfluorooctanoate
(
C8)
Assessment
of
Toxicity
Team
(
CATT)
Report.
Charleston,
WV.
August
2002.

List
of
Subjects
Environmental
protection,
Chemicals,
Hazardous
substances.

Dated:
April
14,
2003.
Stephen
L.
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
9418
Filed
4
 
14
 
03;
1:
26
pm]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0078;
FRL
 
7299
 
2]

Kansas
State
Plan
for
Certification
of
Applicators
of
Restricted
Use
Pesticides;
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Notice
of
intent.

SUMMARY:
The
State
of
Kansas
has
submitted
to
EPA
programmatic
amendments
to
its
State
Plan
for
Certification
and
Training
of
Applicators
of
Restricted
Use
Pesticides.
The
proposed
amendment
establishes
new
requirements
for
the
recertification
of
pesticide
applicators.
Notice
is
hereby
given
of
the
intention
of
the
Regional
Administrator,
Region
VII,
to
approve
the
revised
Plan
for
the
Certification
of
Applicators
of
Restricted
Use
Pesticides.
EPA
is
soliciting
comments
on
the
proposed
amendments.

DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0078,
must
be
received
on
or
before
May
16,
2003.

ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
John
T.
Tice,
Water,
Wetlands
and
Pesticides
Division,
WWPD­
PEST,
100
Centennial
Mall
N.,
Room
289,
Lincoln,
NE
68508;
telephone
number:
(
402)
437
 
5080;
email
address:
Tice.
john@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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