Document ID: EPA-HQ-OPPT-2003-0012-0160
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-08-06T04:00Z

U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
Enforceable
Consent
Agreement
Development
for
Perfluorooctanoic
Acid
(
PFOA)
and
Fluorinated
Telomers
Summary
of
July
10,
2003
Public
Plenary
Meeting
Ninety­
nine
people
attended
the
second
public
enforceable
consent
agreement
(
ECA)
Plenary
session
meeting
on
PFOA
and
fluorinated
telomers
at
EPA
Headquarters
in
Washington,
DC
on
Thursday
July
10,
2003
from
noon
to
3:
30
PM.
The
meeting
participants
represented
registered
interested
parties,
observers,
and
EPA
staff.
Copies
of
the
attendance
list,
the
meeting
agenda,
and
the
four
summary
presentations
made
by
the
PFOA
ECA
Technical
Workgroups
can
be
found
in
the
electronic
docket
at
OPPT­
2003­
0012­
0148.
The
next
plenary
meeting
was
tentatively
scheduled
for
the
week
of
October
20,
2003,
in
Washington,
DC.

I.
Introduction
EPA
welcomed
the
participants
to
the
plenary
session
and
presented
a
brief
review
of
the
current
state
of
affairs.
EPA
summarized
the
agreements
reached
at
the
June
6,
2003
plenary
meeting,
and
described
the
subsequent
technical
workgroup
meetings
held
on
June
23,
June
24,
July
9,
and
July
10,
2003.

A
general
overview
of
the
tasks
assigned
by
the
June
6,
2003
Plenary
to
the
4
workgroups
was
stated
as
follows:
°
The
Communications
Workgroup
was
tasked
with
focusing
on
CBI
issues
and
working
toward
obtaining
a
means
for
industry
to
make
publicly
available
non­
CBI
market
and
production
volume
information
that
would
meet
the
needs
of
interested
parties.
°
The
Monitoring
Technical
Workgroup
was
to
address
technical
details
of
data
needs
involving
environmental
sampling
and
monitoring
in
the
vicinity
of
fluoropolymer
and
telomer
manufacturing
and
use
facilities,
the
selection
and
adaptation
of
monitoring
protocols,
and
the
development
of
sampling
methodologies.
°
The
Fluoropolymer
Technical
Workgroup
was
to
investigate
physical/
chemical
properties,
the
presence
of
PFOA
in
fluoropolymer
treated
articles
during
both
normal
use
and
aged
conditions,
and
incineration
analysis.
°
The
Telomer
Technical
Workgroup
was
to
assess
the
full
set
of
data
needs
expressed
in
the
EPA
Framework
with
regard
to
telomers
and
telomer­
related
products,
with
the
exception
of
PFOA
and
PFOA
precursors
as
related
to
fire
fighting
foam.

Issues
identified
at
the
outset
that
remained
to
be
addressed
by
the
Plenary
due
to
lack
of
agreement
at
the
previous
Plenary
included
fluoropolymer
biodegradation
and
the
potential
for
release
of
and
exposure
to
PFOA
and
PFOA
precursors
from
fire
fighting
foam.
U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
2
Copies
of
the
workgroup
summaries
from
the
June
23
and
June
24
meetings
were
available
at
the
meeting
and
in
the
public
docket
at
OPPT­
2003­
0012­
0132
through
0135.

II.
Summary
of
Workgroup
Activities
Fluoropolymers
Workgroup
Greg
Fritz
of
EPA
presented
a
summary
of
events
from
the
Fluoropolymer
Technical
Workgroup
session.
The
presentation
began
with
a
summary
of
Fluoropolymer
Manufacturers
Group
(
FMG)
commitments
under
the
LOI,
including
Product
Stewardship,
physical
chemical
properties,
and
articles
of
commerce
testing.
FMG
committed
to
providing
information
on
specific
chemical
use
and
production
volume;
submitting
additional
physical
chemical
properties
data
on
selected
polymers;
continuing
to
discuss
fate
and
biodegradation
information;
and
developing
a
timeline
for
ECA
developments
in
two
technical
expert
subgroups.
EPA
agreed
to
review
FMG's
product
selection
criteria
and
to
determine
whether
additional
applications
would
need
to
be
tested.
EPA
indicated
that
the
analysis
of
aged
products
was
an
area
where
additional
work
would
be
needed,
including
the
selection
of
articles
for
testing;
simulation
of
aging
process;
determining
sampling
adequacy
and
product
coverage;
and
adequacy
and
validation
of
testing
methodologies.
EPA
provided
an
ECA
incineration
proposal
for
consideration
by
the
group
which
discussed
selecting
potential
test
substances,
establishing
appropriate
test
conditions,
and
analyzing
for
the
C8
acid
as
well
as
possible
analogs.
The
EPA
proposal
contemplated
a
tiered
approach
for
additional
testing.
The
Workgroup
concluded
that
many
items
from
the
ECA
Preliminary
Framework
document
have
been
addressed
through
the
LOI
commitments.
The
Workgroup
formed
two
technical
expert
subgroups
to
develop
ECA
proposals
for
incineration
and
aged
articles
testing.

Discussion/
Questions:
None
Conclusions:

°
Certain
items
from
the
EPA
Preliminary
Framework
have
been
or
may
be
adequately
met
by
the
LOI
commitments,
including
items
1
(
product
characterization
and
market
information);
2
(
p­
chem
data);
and
6
(
articles
analysis).
°
Recommendation
for
formation
of
expert
technical
subgroups
in
the
areas
of
aged
articles
and
incineration
for
identification
of
LOI
commitments,
testing
protocols,
and
ECA
development.
°
Additional
degradation
information
is
expected
in
the
future.
This
issue
will
remain
in
the
large
Technical
Workgroup
until
a
later
date.
°
Additional
material
balance
information
is
forthcoming.
°
Agreement
on
adequacy
of
Product
Stewardship
efforts.
°
The
Plenary
group
agreed
in
principal
with
the
Workgroup's
conclusions
and
proposed
path
forward.
U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
3
Communications
Workgroup
Harry
Lewis
of
EPA
presented
a
summary
of
events
from
the
Communication
Workgroup.
The
goal
of
the
Communication
Workgroup
was
to
develop
a
roadmap
to
meaningfully
communicate,
within
the
PFOA
ECA
process,
information
regarding
marketing
data,
test
substance(
s),
and
article
identity
in
a
way
that
preserves
proprietary
information
(
CBI)
and
satisfies
the
needs
of
EPA
and
the
interested
parties.
CBI
was
defined
as
any
information
that
can
provide
a
commercial
advantage
and
which
meets
the
regulatory
criteria.
CBI
claims
must
be
based
on
regulatory
criteria
and
involve
commercial
advantage,
with
an
emphasis
on
demonstrating
that
public
disclosure
is
likely
to
cause
"
substantial
harm"
to
competitive
position.
TSCA
Section
14(
b)
was
referenced,
stating
that
health
and
safety
information
can
only
be
claimed
CBI
for
process
and
mixture
proportion
information,
and
that
all
CBI
claims
are
closely
reviewed.
EPA's
task
is
to
balance
the
need
of
the
industry
to
maintain
legitimate
proprietary
information
with
the
need
of
the
public
for
protection.
Public
interest
groups
expressed
an
interest
in
obtaining
CAS
number
and
chemical
structure
information
in
order
to
be
able
to
identify
consumer
products
of
concern.
Groups
questioned
whether
generic
information
would
be
sufficient
for
determining
representative
test
samples
and
which
products
consumers
may
encounter.
Industry
emphasized
that
strategic
decisions
regarding
market
and
product
development
are
very
sensitive
and
must
be
treated
as
confidential,
and
that
they
are
prepared
to
validate
all
CBI
claims
as
necessary.
TRP
stated
that
telomer
products
are
unique
by
end
use
and
by
company.
FMG
noted
that
it
has
provided
the
CAS
numbers
of
approximately
95%
of
the
products
representing
FMG's
markets.
The
Workgroup
concluded
that
in
a
generic
setting,
parties
were
unable
to
agree
about
specific
information
that
would
be
necessary
for
determining
exposure.
The
parties
remanded
specific
determinations
of
information
needed
for
ECAs
to
the
individual
technical
workgroups.
The
Communications
Workgroup
will
reconvene
if
specific
CBI
issues
raised
within
other
workgroups
are
not
resolved
there.
The
Workgroup
noted
that
an
ombudsman
may
be
requested
to
mediate
should
that
be
necessary.

Discussion/
Questions:
None
Conclusions:

°
Suggestion
to
hold
off
meeting
again
until
such
time
as
issues
or
needs
emerge
for
broader
discussion.
Discussion
of
CBI
issues
will
take
place
within
the
Technical
Fluoropolymer
and
Telomer
Workgroups.
°
The
Plenary
group
agreed
in
principal
with
the
Workgroup's
conclusions
and
proposed
path
forward.

Telomers
Workgroup
David
Lynch
of
EPA
reported
on
the
progress
made
in
the
Telomer
Workgroup.
The
Workgroup
noted
that
the
industry
effort
to
gather
marketing
information
is
largely
complete
and
will
be
used
by
EPA
to
inform
the
selection
of
representative
test
chemicals.
Because
much
of
U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
4
this
information
is
claimed
as
CBI,
it
is
not
available
to
the
public,
although
other
federal
agencies,
including
CPSC
and
FDA,
may
have
access
to
it.
The
Workgroup
suggested
the
formation
of
a
technical
subcommittee
where
experts
will
convene
to
develop
an
approach
for
biodegradation
testing
of
representative
telomers
and
telomer­
based
products.
Group
discussions
included
information
being
developed
by
the
Telomer
Research
Program
(
TRP)
under
the
LOI
in
the
areas
of
fate
and
exposures.
EPA
presented
views
on
additional
data
that
may
be
considered
for
ECA
development
beyond
the
LOI
commitments
of
TRP.
The
Workgroup
suggested
the
formation
of
another
technical
subcommittee
to
work
on
further
development
of
a
proposed
incineration
ECA
for
telomers
and
telomer­
based
products
and
articles.
TRP
committed
to
document
their
product
stewardship
activities.

Discussion/
Questions:
None
Conclusions:

°
According
to
EPA,
the
market
information
submitted
under
the
LOI
is
largely
complete.
Because
this
information
is
claimed
as
CBI,
it
is
not
available
to
the
public,
although
other
federal
agencies,
including
CPSC
and
FDA,
may
have
access
to
it.
°
Recommendation
for
formation
of
expert
technical
subgroups
in
the
areas
of
degradation
and
incineration
for
identification
of
LOI
commitments,
testing
protocols,
and
ECA
development.
°
Other
items
identified
for
more
discussion
include
information
soon
to
be
provided
by
companies
on
physical/
chemical
properties,
the
presence
of
PFOA
and
PFOA
precursors
in
products
and
articles,
aging
studies
and
product
stewardship.
°
The
Plenary
group
agreed
in
principal
with
the
Workgroup's
conclusions
and
proposed
path
forward.

Monitoring
Workgroup
Phil
Oshida
of
EPA
reported
on
the
progress
made
in
the
Monitoring
Workgroup.
The
Workgroup
activities
included
EPA
and
industry
presentations
characterizing
and
clarifying
FMG,
3M,
and
TRP
environmental
monitoring
programs
under
the
LOI.
Workgroup
participants
raised
many
questions
and
were
involved
in
much
discussion
on
the
need
for
a
mutual
understanding
and
a
better
focus.
EPA
defined
the
overall
objective
of
the
ECA
activity
as
the
determination
of
how
PFOA
and
PFOA
precursors
are
released
into
the
environment,
their
fate
and
transport
upon
release,
and
the
routes
and
levels
of
human
and
environmental
exposure.
Within
this
overall
objective,
the
objective
of
the
monitoring
program
and
the
role
of
environmental
monitoring
must
be
decided,
including
what
questions
must
be
answered
by
monitoring.
The
Workgroup
participants
concluded
a
technical
subgroup
was
necessary
to
consider
telomer
and
fluoropolymer
monitoring
issues
separately;
to
review
all
data
submitted
to
date;
to
arrive
at
a
common
understanding
of
the
goal
and
objective
of
environmental
monitoring
within
the
context
of
the
overall
investigation
of
PFOA;
to
formulate
questions
specifically
to
be
answered
by
monitoring;
and
to
bring
those
goals
and
questions
back
to
the
main
Workgroup.
U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
5
EPA
committed
to
the
development
of
a
timeline
for
the
subgroup
activities
to
be
circulated
to
interested
parties.
Interested
parties
wishing
to
participate
will
identify
themselves
to
EPA.
The
subgroup(
s)
will
convene
at
least
once
prior
to
the
next
Workgroup
meeting
in
September.
The
Workgroup
participants
suggested
that
the
next
full
Workgroup
meeting
be
scheduled
for
an
entire
day
as
many
issues
need
discussion
and
the
previous
Workgroup
meetings
were
not
adequate
to
accomplish
significant
progress.
One
additional
issue
identified
by
interested
parties
but
not
addressed
by
the
Workgroup
was
the
expressed
need
for
human
blood
sampling
in
the
vicinity
of
manufacturing
facilities
to
determine
the
existence
of
"
hot
spots"
with
higher
blood
levels
than
those
found
in
the
general
population.
EPA
noted
that
blood
sampling
was
not
within
the
purview
of
this
current
ECA
process.

Discussion/
Questions:

Interested
parties
expressed
concerns
regarding
the
absence
of
human
biomonitoring
in
the
ECA
process.
These
parties
stated
their
belief
that
EPA
is
not
making
this
a
major
goal
of
the
ECA
process
and
wanted
clarification
of
this
issue.
EPA
stated
that
the
current
ECA
framework
is
to
understand
areas
of
exposure
in
the
environment
and
that
it
does
not
intend
to
pursue
this
issue
under
the
current
framework.
EPA
recognized
the
importance
of
the
PFOA
levels
in
human
blood,
but
observed
that
the
approach
is
to
gather
information
from
other
sources
prior
to
seeking
any
ECA
commitment
for
blood
monitoring.

One
party
asked
who
would
handle
human
biomonitoring.
EPA
responded
that
it
has
proposed
that
the
Centers
for
Disease
Control
and
Prevention
(
CDC)
undertake
biomonitoring
for
PFOS/
PFOA
materials
via
the
National
Health
and
Nutrition
Examination
Survey
(
NHANES).
EPA
indicated
that,
although
no
final
decision
has
yet
been
made,
EPA
anticipates
that
CDC
will
agree.

One
area
of
particular
concern
to
interested
parties
was
the
possible
transfer
of
PFOA
to
humans.
Parties
questioned
whether
EPA
should
explore
the
penetration
and
skin
migration
of
PFOA
through
contact
with
articles
such
as
carpet
and
clothing.
EPA
stated
that
the
industry
has
responded
to
that
question
in
part
through
the
submission
of
pharmacokinetic
research.
FMG
specifically
expressed
their
willingness
to
share
information
that
they
believe
will
clarify
this
issue.
DuPont
also
expressed
knowledge
of
testing
that
shows
no
skin
migration
of
TRP
products.
EPA
requested
that
the
specific
docket
submission
information
in
the
Administrative
Record
be
provided
for
interested
party
review.

Public
interest
groups
expressed
concerns
regarding
the
formation
of
technical
subgroups
due
to
the
difficulty
in
interested
party
participation
and
lack
of
access
to
the
discussions.
EPA
responded
that
the
ECA
structure
is
designed
to
funnel
detailed
work
into
smaller
technical
subgroups,
but
that
those
subgroups
report
back
to
the
Technical
Workgroups
and
to
the
Plenary
at
a
level
where
all
interested
parties
can
appreciate
and
comment
on
what
was
discussed.
U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
6
Conclusions:

°
Recognize
the
strong
positions
regarding
human
blood
monitoring
to
understand
PFOA
issues.
EPA
is
not
prepared
to
address
at
this
time,
but
is
open
to
addressing
in
the
future.
°
Recommendation
for
formation
of
expert
technical
subgroup(
s)
to
formulate
goals
and
key
questions
on
the
objective
of
the
monitoring
work
under
the
ECA.
°
The
Plenary
group
agreed
in
principal
with
the
Workgroup's
conclusions
and
proposed
path
forward.

III.
Discussion
of
Topics
Remaining
in
Plenary
Session
Two
issues
identified
in
the
previous
Plenary
session
that
required
further
discussion
were
fluoropolymer
fate
data
and
fire
fighting
foam
data.
EPA
noted
that
it
has
come
to
understand
that
fire
fighting
foam
is
principally
C6,
not
C8,
but
the
interest
is
clear
and
there
is
a
continued
desire
for
information.

Representatives
from
FMG
announced
that
additional
fate
data
for
fluoropolymers
had
been
submitted
for
review
on
July
3,
2003.
FMG
requested
that
the
information
be
reviewed
by
the
Agency
and
moved
into
the
fluoropolymer
workgroup
as
an
item
for
further
discussion.
The
group
agreed
with
the
proposal.

A
Fire
Fighting
Foam
Coalition
(
FFFC)
representative
spoke
regarding
the
issue
of
fire
fighting
foam
data.
He
stated
that
an
unpublished
report
of
groundwater
analysis
of
3
Department
of
Defense
fire
fighting
sites
had
been
submitted
to
EPA
on
July
3,
2003
for
review
(
OPPT­
2003­
0012­
0143
and
0144).
The
information
cannot
be
distributed
to
the
public
due
to
pending
publication
in
a
scientific
journal,
but
a
copy
is
available
in
the
reading
room
for
interested
parties
to
review.
The
FFFC
representative
suggested
the
information
be
reviewed
by
the
Agency
and
discussed
at
the
next
Telomer
Workgroup
meeting.
The
FFFC
would
participate
in
the
discussion
and
return
the
issue
to
the
next
Plenary
meeting
for
further
discussion.
The
group
agreed
with
this
proposal.

One
commenter
suggested
that
EPA
enter
into
an
ECA
with
Department
of
Defense,
Department
of
Transportation/
Federal
Aviation
Administration
and
the
Department
of
Homeland
Security
since
those
are
the
agencies
that
mandate
the
use
of
fire
fighting
foams.
A
copy
of
a
1974­
1976
bioassay
of
Air
Force
FC­
206
was
submitted
to
the
public
record
(
OPPT­
2003­
0012­
0152).
EPA
responded
that
an
ECA
is
not
the
appropriate
legal
tool
for
an
agreement
between
agencies,
but
EPA
noted
that
it
has
been
in
contact
with
these
agencies
to
coordinate
with
them
as
the
ECA
activities
progress.
The
Agency
is
open
to
inviting
other
agencies
to
the
technical
discussions.
U.
S.
Environmental
Protection
Agency
Meeting
Summary
August
1,
2003
7
IV.
Next
Steps
Fluoropolymers
Workgroup
°
Development
of
separate
aged
products
and
incineration
technical
expert
subgroups
to
meet
at
least
once
prior
to
the
full
Workgroup
meeting
in
mid­
September.
FMG
will
provide
a
timeline
within
two
weeks.
°
The
Fluoropolymers
Technical
Workgroup
will
convene
during
the
week
of
Sept
15,
2003.

Monitoring
Workgroup
°
Development
of
separate
technical
subgroups
for
fluoropolymers
and
telomers
to
meet
at
least
once
before
the
full
Monitoring
Workgroup
meets
in
mid­
September.
EPA
will
provide
a
timeline
for
subgroup
activities
within
two
weeks.
°
The
Monitoring
Technical
Workgroup
will
convene
during
the
week
of
Sept
15,
2003.

Telomers
Workgroup
°
Development
of
separate
degradation
and
incineration
technical
expert
subgroups
to
meet
at
least
once
before
the
full
Telomer
Workgroup
meets
in
mid­
September.
EPA
will
provide
a
timeline
for
subgroup
activities
within
two
weeks.
°
Suggestion
that
the
information
provided
by
the
FFFC
be
reviewed
by
the
Agency
and
discussed
at
the
next
Telomer
Workgroup
meeting.
The
FFFC
would
participate
in
the
discussion
and
return
the
issue
to
the
next
Plenary
meeting
for
further
discussion.
°
The
Telomer
Technical
Workgroup
will
convene
during
the
week
of
Sept
15,
2003.

Plenary
Session
°
The
next
Plenary
meeting
will
tentatively
convene
the
week
of
Oct
20,
2003.
°
The
Workgroups
will
have
the
option
of
convening
prior
to
the
Plenary
session.

V.
Public
Comments
None
at
this
time.

VI.
Closing
Remarks
EPA
thanked
the
members
of
the
plenary
session
for
their
participation
and
attendance.