Document ID: EPA-HQ-OPPT-2003-0012-0134
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-03T04:00Z

U.
S.
Environmental
Protection
Agency
Meeting
Summary
July
2,
2003
PFOA
ECA
Communications
Workgroup
Meeting
Summary,
6/
24/
03
46
participants;
Attendance
list
in
docket
at
OPPT­
2003­
0012­
0127
The
meeting
included
three
sections:
I.
Presentation
on
CBI
Issues
by:
a.
EPA
b.
Public
Interest
Groups
c.
Industry
II.
Discussion/
Questions
III.
Identification
of
workgroup
next
steps;
determination
of
workgroup
assignments
for
workgroup
and
plenary
meetings
on
July
9
and
10,
2003.

I.
CBI
Issues
Summary
EPA
Harry
Lewis
of
the
Information
Management
Division
of
EPA
began
with
a
discussion
on
Confidential
Business
Information
(
CBI).
He
noted
that
the
TSCA
CBI
security
structure
is
considered
one
of
the
most
advanced
and
onerous
protection
schemes
for
CBI
in
the
Agency.
CBI
is
defined
as
any
information
that
can
provide
a
commercial
advantage
and
which
meets
the
regulatory
criteria.
Some
examples
are
trade
secret
information,
chemical
identity,
name,
company
facility,
processes,
and
intellectual
property.
Often
CBI
claims
are
misunderstood.
A
company
cannot
claim
non­
commercial
information
for
protection
from
public
scrutiny.
The
TSCA
CBI
program
will
protect
any
claimed
information
until
such
time
as
a
challenge
is
presented,
or
the
Agency
decides,
on
its
own
initiative,
to
review
the
claim.
All
CBI
is
treated
as
such
until
a
final
determination
of
CBI
claims
is
made
by
the
Office
of
the
General
Counsel.

Any
health
and
safety
information
that
indicates
a
risk
to
human
health
and
the
environment,
including
any
TSCA
8(
e)
notice
of
substantial
risk,
would
be
closely
reviewed
for
its
CBI
claims
because
of
the
restrictions
in
section
14(
b)
on
claiming
health
and
safety
information
as
CBI
and
the
great
importance
of
protecting
the
public.
Often
the
company
identity
and
chemical
identity
are
declared
as
confidential.
The
Agency
negotiates
with
submitters
to
release
pieces
of
information
for
the
public
good.
Regulatory
criteria
for
justification
of
CBI
are
found
under
40
CFR
2.208.
Submitters
should
carefully
consider
these
criteria
before
submitting
any
claim
of
CBI
to
the
Agency.
The
company
has
to
satisfactorily
show
that
the
disclosure
of
CBI
is
likely
to
cause
"
substantial
harm"
to
its
competitive
position.

Consideration
of
how
to
present
data
so
it
is
useful
is
very
important.
When
negotiating
with
the
submitter
of
CBI,
it
may
be
necessary
to
discuss
what
information
is
necessary
versus
what
information
is
desired.
All
non­
CBI
information
goes
into
public
files
in
consideration
of
the
public's
right
to
know.
For
the
purpose
of
identification
of
chemicals
for
public
information,
a
generic
form
of
the
information
may
be
appropriate
(
e.
g.,
family
of
chemicals).
The
Agency
must
balance
the
need
of
the
public
for
information
with
the
need
of
industry
to
maintain
proprietary
data,
and
answer
the
question
of
what
information
is
crucial
for
protection
of
both
the
public
and
the
industry.
U.
S.
Environmental
Protection
Agency
Meeting
Summary
July
2,
2003
2
Public
Interest
Groups
EWG
indicated
that
its
primary
concerns
are
for
how
much
CBI
claims
may
interfere
with
the
public's
ability
to
evaluate
the
products
proposed
for
testing
in
the
LOI
and
through
any
ECA.
EWG
questioned
whether
general
categories
of
use
would
provide
a
sufficient
level
of
information
to
allow
parties
to
judge
the
representativeness
of
the
samples
and
to
know
which
products
consumers
may
encounter.
EWG
questioned
whether
sufficient
information
would
be
provided
to
allow
the
public
to
make
purchasing
and
use
decisions
that
would
allow
informed
consumer
choice
to
limit
exposures
to
these
chemicals.

Industry
Representatives
from
industry
summarized
the
importance
of
CBI
and
the
approaches
they
use
to
provide
information
to
the
public.
The
most
important
consideration
from
the
industry
perspective
is
competitive
advantage.
The
competitive
nature
of
the
market
is
such
that
information
on
strategic
decisions
about
the
market
or
a
direction
a
company
takes
in
product
development
is
extremely
sensitive
and
considered
CBI.
Industry
expressed
their
understanding
of
the
need
to
provide
the
government
and
the
public
with
health
and
safety
and
environmental
impact
information;
however,
they
stated
that
it
must
be
presented
in
a
way
that
balances
private
and
public
interest.
The
industry
indicated
that
it
is
prepared
to
validate
any
and
all
CBI
claims
as
deemed
necessary,
and
that
all
available
information
will
be
provided
in
forms
 
including
aggregated
data
 
where
no
CBI
is
compromised.
It
was
noted
that
trade
names
and
CBI
are
not
necessarily
the
same.
TRP
noted
that
the
telomers
industry
and
telomer
products
are
unique
by
company
and
by
end
use,
and
that
the
products
are
sold
for
what
they
do
(
performance),
not
for
what
they
contain.
These
are
important
considerations
when
providing
information
and
maintaining
confidentiality.

II.
Discussion/
Questions
Interested
parties
asked
how
the
public
could
challenge
a
confidentiality
claim.
EPA
responded
that
the
public
may
petition
EPA
under
the
Freedom
of
Information
Act
(
FOIA)
for
review
of
the
confidential
claims
of
the
submitter.
The
EPA
would
make
a
determination
of
confidentiality
claims.
Should
the
claims
be
validated,
the
public
can
submit
an
appeal.
Should
the
claims
not
be
validated,
then
the
submitter
would
be
notified
and
would
have
30
days
to
challenge
the
determination
prior
to
release
of
the
information.

One
unresolved
question
involved
the
definition
of
health
and
safety
information
that
could
not
properly
be
claimed
as
CBI.
Parties
noted
that
exposure
information
could
be
considered
within
the
scope
of
health
and
safety
data
and
thus
should
not
be
claimed
as
CBI.
Meeting
attendees
questioned
how
CBI
claims
would
affect
their
ability
to
evaluate
the
context
and
meaning
of
information,
as
well
as
the
level
of
data
revealed
and
the
communication
of
study
results.

Parties
raised
concerns
about
the
way
EPA
would
judge
whether
test
substances
would
be
representative,
and
expressed
hesitation
at
having
EPA
as
the
exclusive
filter
of
CBI
data
because
U.
S.
Environmental
Protection
Agency
Meeting
Summary
July
2,
2003
3
of
the
volume
of
potential
claims
and
the
time
and
effort
that
would
be
required
to
review
all
claims
and
make
determinations.
One
participant
indicated,
as
an
illustration,
that
approximately
40
studies
on
PFBS
(
perfluorobutane
sulfonate)
had
been
submitted
to
the
Agency
under
CBI
claims
and
were
not
available
to
the
public.
Parties
questioned
whether
there
was
a
better
and
faster
way
to
make
data
available,
given
that
the
process
to
sort
out
CBI
claims
on
individual
studies
could
take
years.
One
suggestion
was
for
the
companies
to
provide
a
sanitized
public
version
of
all
study
results
to
allow
the
information
to
be
made
more
readily
available,
as
is
generally
required
in
certain
cases
under
the
existing
regulations.

One
suggestion
of
the
group
was
to
identify
necessary
data
elements
and
try
to
come
up
with
agreement
on
how
that
information
would
be
provided.
Most
of
the
discussion
on
this
point
addressed
specific
chemical
identities
as
indicated
by
CAS
number
or
chemical
structure,
and
no
agreement
was
reached.
Although
FMG
noted
that
the
CAS
numbers
already
provided
in
its
LOI
represented
about
95%
of
the
polymers
in
their
markets,
the
TRP
noted
that
the
specific
composition
of
many
telomer
chemical
products
is
CBI
with
great
commercial
value,
and
the
CAS
numbers
and
structures
could
thus
not
be
made
public.
Participants
from
the
public
interest
sector,
on
the
other
hand,
indicated
that
CAS
numbers
and/
or
chemical
structures
were
critical
for
their
analysis
of
substances,
citing
the
examples
that
a
CAS
number
could
be
used
to
search
the
Internet
and
identify
potential
consumer
products
of
concern,
while
chemical
structure
would
be
necessary
to
determine
the
mechanisms
of
toxicity
and
to
identify
potential
breakdown
products.
An
EPA
representative
provided
a
guideline
used
by
the
Agency
in
developing
generic
names
for
confidential
chemicals
as
one
suggestion
of
an
approach
to
address
providing
information
without
compromising
legitimate
CBI
claims.
This
document
is
in
the
docket
at
OPPT­
2003­
0012­
0127.

The
group
encountered
substantial
difficulty
in
discussing
the
issues
generically,
given
that
the
parties
had
very
specific
questions
about
how
various
chemicals
are
used
and
whether
their
use
in
various
products
might
present
exposure
issues.
The
group
concluded
that
the
discussion
of
how
to
communicate
essential
information
should
focus
on
what
information
is
necessary
to
develop
an
ECA,
and
should
be
addressed
in
the
other
technical
workgroups
specifically
with
reference
to
what
information
is
needed
and
what
information
is
claimed
CBI
in
the
context
of
the
testing
proposals
under
development
in
those
technical
workgroups.
Another
suggestion
was
that
an
ombudsman
could
be
named
to
bring
groups
and
individuals
together
if
necessary
to
discuss
and
resolve
issues
as
they
develop.

The
group
determined
that
progress
in
the
other
workgroups
may
change
the
focus
of
discussions
and
clarify
what
data
elements
are
necessary
and
how
to
agree
upon
sharing
that
information.
The
workgroup
will
not
reconvene
unless
and
until
participants
feel
that
there
are
issues
that
the
group
needs
to
resolve.
The
group
nominated
Harry
Lewis
to
be
the
Communications
Workgroup
spokesperson
at
the
plenary
meeting
on
July
10,
2003.

III.
Next
Steps
°
No
action
items
at
this
time.