Document ID: EPA-HQ-OPPT-2003-0012-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-03T05:00Z

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UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
C,

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44
L
PRO~
0
SEP
272002
OFFICE
OF
PREVENTION.
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
SUBJECT:
Revision
ofPFOA
Hazard
Assessment
and
Next
Steps
FROM:
Charles
M.
Auer,
DirectoC&~
t
/~
CLk_­
Office
of
Pollution
Prevention
and
Toxics
TO:
Oscar
Hernandez,
Director
Risk
Assessment
Division
Mary
Ellen
Weber,
Director
Economics,
Exposure,
and
Technology
Division
Ward
Penberthy,
Acting
Director
Chemical
Control
Division
As
part
ofthe
effort
by
the
Office
ofPollution
Prevention
and
Toxics
(
OPPT)
to
understand
health
and
environmental
issues
presented
by
fluorochemicals
in
the
wakenf
unexpected
toxicological
and
bioaccumulation
discoveries
with
respect
to
perfluorooctyl
sulfonates
(
PFOS),
OPPT
has
been
investigating
perfluorooctanoic
acid
and
its
saItsJfFOA~
OPPT
released
a
preliminary
Draft
Hazard
Assessment
ofPerfluorooctanoic
Acidxzn.
dits
Salts,
dated
February
20,
2002,
on
March
28,
2002,
and
issued
a
minorcorrection
to
that
document
on
April
15,
2002.
That
draft
assessment
indicated
potential
systemic
toxicity
and
carcinogenicity,
and
observed
that
blood
monitoring
data
suggested
widespread
exposure
to
the
general
population,
albeit
at
low
levels.
It
also
noted,
however,
that
additional
toxicity
studies
were
underway
on
other
endpoints
and
that
further
data
would
be
available
within
amatter
ofmonths.

The
Agency
has
since
received
considerable
additional
data.
The
additional
toxicology
data
submitted
to
the
Agency
suggest
a
potential
for
reproductive/
developmentattoxicity,
and
additional
blood
sample
analysis
data
indicate
low
level
exposures
to
the
general
population
that
are
unexplained
at
this
time.

Stephen
Johnson,
Assistant
Administrator
ofthe
Office
ofPrevention,
Pesticides,
and
Toxic
Substances
(
OPPTS),
met
with
representatives
from
the
manufacturers
and
users
of
PFOA
and
related
chemicals
on
August
13,
2002.
He
requested
continued
discussion
with
Internet
Address
(
URL)
°
http:
f/~
w.
epa.
gov
RecycledlRecyclable
.
Printed
with
Vegetable
Oil
Based
Inks
on
Recycled
Paper
(
Minimum
50%
Postconsumer
conten*
2
manufacturers
and
users
ofPFOA
and
related
chemicals
to
further
investigate
theseissues,
Mad
raised
the
importance
of
and
need
for
communicating
with
the
public.
Following
that
meeting,
OPPTS
met
with
toxicologists
from
industry
on
August
30,
2002,
to
discuss
the
recentstudy
submissions
and
any
additional
anticipated
work.
OPPT
also
met
by
conference
call
with
manufacturer
representatives
on
September
12,
2002
to
explore
existing
exposure
information
and
identif~'
gaps
in
those
data
that
may
help
to
explain
the
presence
ofPFOA
in
the
blood
ofthe
general
population.
Summaries
ofthese
meetings
are
being
placed
in
the
public
administrative
record
for
this
investigation,
AR­
226:
PFOS,
PFAS,
PFOA,
Telomers,
and
Related
Chemicals.

An
interim
revised
hazard
assessment
updating
the
original
Draft
HazardAssessment
to
incorporate
OPPT's
reviews
ofthese
data
has
been
prepared.
As
soon
as
this
document
completes
internal
review
procedures,
it
should
be
placed
in
AR­
226.
Please
proceed
to
finalize
this
interim
revised
hazard
assessment
within
the
next
four
to
six
weeks,
at
which
time
wrwili
place
the
document
in
the
public
file.

The
reproductive/
developmental
toxicity
data,
the
carcinogenicity
data,
and
the
blood
monitoring
data
reviewed
in
the
interim
revised
hazard
assessment
raise
the
possibiitythatPF&
A
might
meet
the
criteria
for
action
under
section
4(
f)
ofthe
Toxic
Substances
Control
Act.

The
Agency
established
a
process
in
1991
for
determining
whether
the
TSCA
§
4(
t)
criteria
are
met,
and
published
that
process
in
a
Federal
Register
notice
concerning
refractory
ceramic
fibers
(
RCF)
(
56
FR
58693;
November
21,
1991).
With
this
memo,
I
am
requesting
That
you
now
initiate
a
priority
review,
as
described
in
that
notice,
to
determine
the
significance
ofthe
risks
presented
by
PFOA
and
its
salts.
This
priority
review
should
begin
while
you
proceed
with
the
finalization
ofthe
interim
revised
hazard
assessment.
It
is
my
understandingthat
you
have
also
initiated
a
request
with
the
Science
Advisory
Board
(
SAB)
for
a
peer
review
ofthe­
preliminary
risk
assessment
focused
on
developmentaL'reproductive
­
toxicity
that
will
be
developecLbase4
on
this
priority
review.

It
is
my
expectation
that
the
hazard
assessment
priority
review
will
be
completed
in
the
next
four
to
six
weeks.
Please
be
prepared
to
discuss
these
issues
when
we
meet
with
the
Assistant
Administrator
on
next
steps
cc:
S.
Johnson
S.
Hazen
M.
Schneider
Administrative
Record
AR­
226:
PEOS,
PFAS,
PFOA,
Telomers,
and
Related
Chemicals