ftR0?~
26_
O&
39'

PFOS
Presentation
to
CMA,
June
19,
2000
Charles
M.
Aner,
Director
Chemical
Control
Division
2000
SEP
6
PH
(
2:
58
U.
S.
Environmental
Protection
Agency
BACKGROUND
PFOS
(
perfluorooctane
sulfonic
acid)
is
a
member
of
a
large
family
ofsulfonated
perfluorochemicals
(~~
jannual
production
of
the
PFOS
family
is
<
10
million
ibs)
which
are
used
for
a
wide
variety
ofindustrial,
commercial,
and
consumerapplications
(
including
use
as
a
component
of
soil
and
stain­
resistant
coatings
for
fabrics,
leather,
furniture,
and
carpets,
In
fire­
fighting
foams,
commercial
and
consumer
floor
polishes,
cleaning
products,
and
as
a
surfactant
in
other
specialty
applications).
Pesticidal
and
indirect
food
use
products
are
also
made
from
this
technology.

611
ofthese
chemicals
have
the
potential
to
degrade
back
to
PFOS
which
does
not
appear
to
degrade
further
(
it
is
thus
highly
persistent).
3M
Corporation
is
the
sole
US
manufacturer
ofthe
PFOS
family
of
chemicals.

PFOS
has
been
found
widely
in
human
blood
samples
(
ppm
levels
in
manufacturing
workers,
ppb
levels
in
non­
exposed
workers
and
in
blood
bank
samples)
based
on
3M
research.
PFOS
has
also
been
found
in
wildlife
species
across
the
US
(
especially
in
fish
eating
birds)
and
was
detected
in
naive
(
unexposed)
laboratory
rats
(
the
PFOS
contamination
was
traced
back
to
fish
meal
used
in
the
rat
chow).

PFOS
caused
postnatal
deaths
(
and
other
developmental
effects)
in
offspiIng
in
a
2­
generation
reproductive
effects
rat
study
(
NOAEL
of
0.1
mg/
kg/
day
and
LOAEL
of
0.4
mg/
kg/
day).
At
higher
doses
in
this
study,
progeny
in
the
first
generation
died,
while
at
the
LOAEL
reducedpup
weight
gain
was
observed.

PFOS
accumulates
to
a
high
degree
in
humans
and
animals.
It
has
an
estimated
half­
life
of
4
years
in
humans.
It
thus
appears
to
combine
Persistence,
Bioaccumulation,
and
Toxicity
properties
to
a
high
degree.

3M
had
previously
launched
a
major
research
effort
on
PFOS
to
characterize
its
environmental
presence,
environmental
and
human
effects,
and
environmental
fate.
EPA
continues
to
receive
the
results
ofthis
work
and
will
make
it
available
as
it
comes
in.

EPA
REVIEW
Preliminary
data
indicated
to
EPA
that
PFOS
is
of
significant
concern
on
the
basis
ofevidence
of
widespreadhuman
exposure
and
indications
of
toxicity
in
the
2­
generation
rat
study.
In
addition,
EPA's
preliminary
risk
assessment
indicated
potentially
unacceptable
margins
of
exposure
(
MOBs)
for
workers
and
possibly
the
general
population.

I
There
are
many
assumptions
and
considerable
uncertainty
in
these
arguments
and
analyses.
It
is
not
possible
at
present
to
judge
the
adequacy
or
accuracy
ofthe
MOE
analyses
or
whether
the
exposure
levels
used
in
the
above
estimations
may
be
considered
representative
ofthe
affected
populations
at
large.

EPA
has
requested
detailed
information
from
3M
and
a
large
body
of
information
has
been
received
but
not
fully
reviewed.
Review
ofsubchronic
studies
provided
by
3M
on
monkeys
and
rats
also
show
deaths
at
doses
similar
to
those
reported
in
the
2­
generation
study.

3M
has
raised
questions
regarding
the
possible
relevance
to
humans
of
a
proposed
mechanism
(
effects
on
cholesterol
biosynthesis)
for
PFOS's
lethal
effect
in
the
2­
generation
study.
The
proposed
mechanism,
the
company
argues,
affects
reproductive
outcomes
in
litter
bearing
animals
due
to
its
inhibitory
effect
on
a
burst
of
cholesterol
biosynthesis
in
the
critical
period
just
before
birth.

The
proposed
mechanism
would,
if
demonstrated,
have
broad
implications
for
and
present
significant
potential
concerns
for
humans
and
environmental
organisms.
At
this
time
it
is
not
clear
what
is
going
on
in
PFOS
toxicology
 
nonetheless,
the
persistent
presence
ofdeaths
in
multiple
studies
involving
multiple
species
at
roughly
equivalent
doses
raises
flags.

PHASE
OUT
DECISION
BY3M
Following
a
series
ofdiscussions
with
EPA,
and
based
on
concerns
about
the
widespread
presence
and
longer
term
risks
presented
by
PFOS,
3M
announced
that
it
would
exit
worldwide
from
this
market
by
about
the
end
ofthe
year,
although
itmay
need
to
extend
the
time
period
for
some
critical
uses
(
e.
g.,
fire
fighting
foam).

EPA
agrees
that
continued
manufacture
and
use
of
PFOS
represents
an
unacceptable
technology
that
should
be
eliminated
to
protect
human
health
and
the
environment
from
potentially
severe
long
term
consequences.
The
company
has
committed
to
continue
its
research
effort
despitethe
commercial
decision.
3M
has
expressed
interest
in
collaborative
efforts
withEPA
as
they
withdraw
from
the
market
and
in
the
development
of
safer
substitutes.

EPA
is
currently
exwnining
appropriate
regulatory
alternatives
necessary
to
protect
human
health
and
environment
in
light
of3M's
phaseout
decision
on
PFOS.
More
information
will
be
made
available
as
our
strategy
becomes
clarified.

EPA
strongly
supports
continued
research
on
PFOS
to
improve
our
understanding
ofit
fate
and
effects
to
humans
and
the
environment.
A
more
complete
understanding
of
the
environmental
fate
ofPFOS
derivatives,
including
polymers,
is
particularly
important
to
allow
an
assessment
of
the
longer
term
consequences
of
the
PFOS
which
has
been
released
into
the
environment.

EPA
is
prepared
to
workwith
industry,
both
manufacturers
and
users,
to
assist
in
review
of
critical
uses
of
PFOS
to
ensure
that
good
decisions
are
made
in
those
cases
where
risk/
risk
2
tradeoff
issues
are
presented
by
the
phaseout
decision.
These
uses
include
fire
fighting
foam
and
acid
mist
suppression.

PFOS
ALTERNATIVES
AND
RELATED
SUBSTANCES
Users
ofPFOS­
based
products
are
confrontingthe
need
to
replace
PFOS.
Various
materials
have
been
identified
as
substitutes
for
these
uses.
EPA
recommends
that
alternatives
be
carefUlly
evaluated
to
identi~'
possible
hazard
or
risk
issues.
EPA
is
prepared
to
work
with
individual
manufacturers
ofalternatives
which
are
available
or
under
development
as
substitutes
for
PFOS
to
ensure
that
good
decisions
are
made.

As
the
work
on
PFOS
progresses,
EPAplans
to
broaden
its
review
to
encompass
other
highly
fluorinated
acids,
including
PFOA
and
other
materials,
including
the
telomers.

PFOA
PFOA
(
perfluorooctanoic
acid)
is
closely
related
structurally
to
PFOS
and
is
used
a's
a
solvent
for
certain
polymerization
reactions.
EPA
has
requested
information
from
producers
and
will
be
preparing
an
assessment.
Based
on
preliminary
information,
PFOA
presents
a
different
hazard,
exposure,
and
risk
picture
compared
to
PEOS.
3M
has
also
committed
to
endingproduction
of
PFOA.
There
are
other
producers
in
the
US
and
EPA
is
examining
its
options
regarding
action
on
PFOA.
We
are
aware
ofindustry
concerns
regarding
the
availability
ofsubstitutes
for
PFOA
in
its
fluoropolymer
reaction
solvent
application.

TELOMERS
AND
OTHER
PERFLUORO
CHEMISTRIES
EPA
has
not
yet
looked
into
the
telomers
and
other
perfluoro
chemistries.
The
ITC
will
be
requesting
information
on
a
broad
array
of
fluorinated
derivatives
and
we
will
be
working
with
them
aspart
of
our
assessment
effort.
The
telomers
represent
an
interesting
alternative
to
PFOS
and
we
encourage
industry
efforts
to
inform
EPA
and
others
regarding
the
fate
and
effects
of
these
materials.
Ofparticular
interest
to
EPA
in
this
regard
is
to
understand
the
environmental
fate
ofthese
materials,
including
to
what
extent
do
the
various
derivatives
degrade
to
PFOA
and
what
are
the
rates
and
extent
ofthis
degradation
under
various
environmental
conditions.

3
