Document ID: EPA-HQ-OEI-2003-0001-0253
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-09-20T04:00Z

RESOLVE
Establishment
of
Electronic
Reporting;
Electronic
Records
October
29,
2001
Tapes
1
through
5
[
To
improve
the
succinctness
of
these
transcripts,
the
facilitator's
comments
have
been
minimized
or
deleted.

Comments
by
hearing
participants
that
were
inaudible
or
not
specifically
about
the
subject
matter
have
also
been
deleted.

Minor
edits
have
been
made
to
improve
readability.
Raw
transcripts
are
available
from
RESOLVE
upon
request.]

Robin
Roberts:
Welcome
to
this
informal
public
hearing
on
the
proposed
establishment
of
the
Electronic
Reporting
and
Recordkeeping
Rule.
I'm
Robin
Roberts,
a
mediator
with
RESOLVE.
I'm
not
an
employee
of
EPA
nor
do
I
advocate
for
any
of
their
policies.
I'm
here
to
ensure
that
the
agenda
is
honored
and
that
we
keep
to
the
times
of
the
topics
indicated
on
the
agenda 

The
purpose
of
this
informal
public
hearing
is
to
provide
you,
the
interested
public,
with
an
opportunity
to
supplement
your
formal
written
comments
to
EPA
with
oral
comments
and
to
seek
clarification
where
needed
on
the
rule.
The
proposed
electronic
reporting
and
records
rule
was
published
on
August
2
31.
The
formal
public
comment
period
ends
November
29
and
written
comments
must
be
submitted
to
the
docket
by
that
time.

Instructions
for
submitting
comments
are
included
in
the
preamble
of
the
rule.
The
informal
hearing
is
not
intended
in
lieu
of
submitting
formal
written
comments.
Nonetheless,
this
hearing
is
being
recorded
and
a
transcript
of
this
hearing
will
be
added
to
the
docket.

Just
as
a
point
of
logistics 

On
the
panel,
I'd
like
to
introduce
Joe
Retzer,
Director
of
the
Collections
Services
Division,
Michael
LeDesma
of
the
Office
of
General
Counsel
and
also
part
of
the
Electronic
Reporting
and
Recordkeeping
Rule
Workgroup
at
EPA,
and
David
Schwarz,
co­
chair
for
the
workgroup,
and
Evi
Huffer,
also
cochair
of
the
workgroup.

Before
we
head
into
this,
I'd
just
like
to
have
you
all
pull
out
your
agendas
and
take
a
look 
Female
Participant:

The
preamble
areas
that
we've
listed
are
basically
the
main
areas
where
you'll
find
that
topic.
However,
we'll
take
any
questions,
any
comments
that
you
have
on
anything.

If
you
do
have
a
comment,
I'll
have
to
ask
that
you
come
down
here 

Ground
rules 

So,
with
no
further
ado,
I'd
like
to
kick
off
part
one
of
the
agenda,
where
we'll
go
into
EPA's
electronic
reporting
rule
3
and
its
electronic
signature
requirements.
This
is
Preamble
Part
IV.
A.,
Subpart
A
and
B.
Are
there
any
comments
on
the
preamble?

Kathleen
Barrowclough:
No
comments
on
electronic
reporting
in
that
area?

Robin
Roberts:
Well,
let's
take
this
by
preamble.
Preamble,

Part
IV,
section
A,
the
general
requirements
section.

Evi
Huffer:
We
were
not
planning
on
giving
a
presentation.

This
is
basically
a
commentary
for
the
public
on
the
proposed
rule.
And
this
first
section
deals
with
electronic
reporting
directly
to
USEPA
(
inaudible).
Electronic
reporting
directly
to
EPA,
including
the
electronic
signature
certification
scenario
that's
discussed
in
the
preamble
to
the
rule.
I
mean,

if
everyone
is
happy
with
it,
we're
happy.

Kathleen
Barrowclough:
Kathy
Barrowclough,
DuPont,
I'm
representing
the
SQA
here.
And
I
believe
that
if
you're
talking
about
the
area
where
you're
discussing
electronic
reporting
that
we
have
a
question
related
to
that.
And
it's
around
the
basis
that
EPA
may
have
had
for
choosing
a
complex
submit
a
registration
and
electronic
signature
certification
process
over
a
system
similar
to
that
used
by
OPP
for
FIFRA'S
GLP
submissions
whereby
the
submission
is
provided
on
a
CD
along
with
a
signed
hard
copy
of
a
document
called
a
certification
in
lieu
of
electronic
signature
with
respect
to
4
data
integrity.

We
would
like
to
know
the
rationale
for
the
increased
complexity
in
CROMERRR
considering
that
FIFRA
has
significant
legal
penalties
anyway
for
providing
false
information
to
the
agency.
Additionally,
the
FDA
procedure
for
certification
of
electronic
signatures
is
a
much
less
burdensome
process
whereby
companies
submit
a
letter
to
FDA
signifying
that
they're
holding
their
people
accountable
for
their
electronic
signatures.

David
Schwarz:
Let
me
see
if
I
can
answer
at
least
some
of
the
question.
Probably
in
answer
to
the
CD
and
signature
page,

there's
nothing
in
the
rule
that
prohibits
that.
I
forget
exactly
where
in
the
rule
that
we
say
it,
but
we
say
it
quite
clearly
in
the
preamble
that
the
rule
does
not
apply
to
submission
on
CD.
So
in
the
case
of
the
reporting
that
you're
referring
to,
the
final
rule
would
not
in
any
way
interfere
with
that
process.
What
the
rule
does
attempt
to
address
is
signature
and
certification
where
there
is
no
paper
at
all.

And
in
fact,
where
the
submission
comes
in,
not
on
a
physical
object
that
you
handle,
but
comes
in
in
some
way
over
the
wires.
And
that's
really
the
focus
of
the
rule.

So
that,
I
think
that
may
explain
the
difference
in
procedure.
Where
things
do
come
in
on
some
kind
of
magnetic
media,
whether
it's
a
CD
or
a
diskette
or
tape
or
whatever,
the
5
rule
is
simply
silent
on
that.
And
that
was
my
intention.

Does
that
address
your
question?
Okay.

Pat
Woods:
I'm
Pat
Woods
with
Georgia
Pacific.
And
I'm
also
here
representing
CEEI,
the
Council
for
Executive
and
Environmental
Information.
I
don't
have
any
written
comments
at
this
point
on
the
recording
portion
of
it,
other
than
I
feel
I
can't
sit
silently,
which
might
imply
that
we're
supportive
of
it.
We
have
spent
so
much
time
trying
to
understand
the
record­
keeping
portion
of
it,
and
have
such
concerns
there,

that
we
have
really
not
yet
fully
worked
our
way
through
understanding
what
you're
asking
for
with
reporting.

I
want
it
to
be
known
that
we're
certainly
supportive
of
the
concept
of
this,
and
have
been
supportive
of
it
for
some
time.
But
what
seems
to
be
there
seems
to
be
unnecessarily
complex.
And
I
say,
we
have
not
really
begun
to
focus
on
(
inaudible)
on
the
second
portion.
So
I
expect
we
will
have
more
comments,
but
I
wanted
to
at
least
go
on
record
and
say
it
looks
as
though
there's
more
there
than
needs
to
be
there.

Howard
Kruger:
Good
morning.
I'm
Howard
Kruger
from
Proctor
and
Gamble,
Cincinnati,
Ohio.
Regrettably,
I
have
prepared
comments,
but
I
prepared
them
in
the
context
of
the
holistic
rule
in
and
of
itself.
And
it's
not
conveniently
broken
down.

What
I
had
assumed,
having
looked
at
your
agenda
in
advance,
I
thought
you
would
probably
just
be
making
a
couple
of
key
6
points
under
each
one,
but
you
would
not
ask
people
to
break
down
their
points
item
by
item.
But
I
actually
went
through
here
and
just
grabbed
a
couple
of
things,
so
I
can
make
a
few
comments
to
you.

First
of
all,
it
actually
states
in
the
rule
"
that
the
rule
would
allow
electronic
reporting
by
regulated
entities."

I'm
on
the
first
page
of
my
document.
"
Would
allow
electronic
reporting
by
regulated
entities
to
the
EPA"
and
would
further
"
allow
these
regulated
entities
to
keep
mandated
records
electronically."

Well,
this
actually
creates
a
false
impression.
If
you
really
didn't
know
better,
you
would
conclude
that
there
is
no
electronic
reporting
going
on
in
the
United
States
of
America
right
now,
and
yet
this
is
pervasively
embedded
into
the
structure
of
our
normal
business
operations
throughout
the
country
right
now.
I
think
we
all
understand.
So
if
you
really
didn't
know
any
better,
you'd
say
that,
you
know,
this
is
not
now
a
common
occurrence.
Which
of
course
it
is.
And
so
herein
lies
some
significant
problems.
How
do
you
reconcile
the
ongoing
status
of
existing
technology
and
existing
systems
and
the
current
electronic
reporting
with
the
new
requirements
in
the
rule?

And
I
guess
really
then,
first
and
foremost,
the
rule
really
is
not
voluntary.
And
although
the
proposal
itself
7
gives
you
the
impression
that
it's
voluntary,
its
requirements
would
be
mandatory
for
all
use
of
computers
to
meet
any
EPA
or
record­
keeping
requirements.
And
as
I
said
before,
computers
are
pervasively
embedded
into
the
U.
S.
economy
with
the
full
range
of
business
communications,
reporting
and
record­
keeping.

And
this
just
isn't
going
to
change;
certainly
it
isn't
going
to
change
any
time
soon.
So
as
a
practical
matter,
for
all
reporting
entities,
you
would
have
to
comply
with
the
CROMERRR
rules.
I
mean,
there's
no
way
that
we
can
go
back
to
the
days
where
we
tried
to
manage
our
businesses
with
paper.
It's
just
economically
no
longer
feasible.
So
that
means
that
somehow
you'd
have
to
adapt
your
existing
computer
systems
and
your
reporting
schemes
...
to
me,
CROMERRR
rules,
or
you
would
somehow
have
to
go
out
of
business.
I
have
no
answer.

I
would
also
point
out
that
on
page
46164,
column
one
at
the
bottom,
the
statement
is
provided
that
"
many
facilities
do
not
submit
documents
directly
to
EPA
but
rather
to
states,

tribes
or
local
governments."
Well
we're
all
aware
of
that.

And
that
these
groups
"
authorized
to
delegate
to
administer
a
federal
environmental
program
on
EPA's
behalf
in
lieu
of
the
federal
regulatory
program."

Now,
nowhere
does
the
proposal
recognize
that
in
many
instances,
under
such
states,
environmental
programs
where
you've
delegated
to
the
states
to
help
you
out,
that
electronic
8
reporting
is
actually
required.
It's
not
an
option.
Some
of
the
states
actually
require
it.

In
one
instance,
it's
been
reported,
and
I'm
still
trying
to
track
all
of
the
details
on
this
down
...
I'll
have
them
down
by
the
28th
of
November,
but
in
one
case
it's
been
reported,
under
Section
311
and
312,
that
if
you
do
not
report
electronically,
that
you
will
actually
incur
a
fine.
Also,

electronic
reporting
is
encouraged
if
not,
in
some
cases,

mandated
under
Title
V.
So
you
have
these
two
juxtapositions,

voluntary
and
yet
some
of
the
exact
ways
in
which
you
would
have
to
report,
there's
actually
mandatory
electronic
reporting.
So
to
me
this
invalidates
the
concept
of
voluntary.

Those
are
the
only
things
I
could
pull
out
of
my
comments
right
now.

Joe
Retzer:
Could
I
ask
you
a
question?

Howard
Kruger:
Sure.

Joe
Retzer:
The
electronic
reporting
that
you
refer
to,
is
this
reporting
over
a
network,
or
is
this
reporting
by
submitting
a
CD
or
a
diskette.
The
distinction's
important.

Howard
Kruger:
I
honestly
can't
tell
you.

Joe
Retzer:
Okay,
because
...

Howard
Kruger:
It's
just
been
so
short
a
period
of
time.
I've
tried
to
contact
all
my
plants
and
so
forth.
I
started
out,
in
my
thing
here,
to
give
you
an
idea
of
how
complex
this
is,
we
9
have
37
manufacturing
plants
in
24
states.
And
they're
all
subject
to
EPA
environmental
reporting
requirements.
And
they
vary
all
over
the
place.
And
the
states
do
not
...
it's
not
like
there's
a
uniform
program,
every
state
administers
the
same
...
it's
just
all
over
the
map.
So
we've
got
24,
really,

24
different
ways,
and
many
of
the
states
will
allow,
but
some
actually
require
electronic
reporting.
And
if
you
don't
report
electronically,
you
get
fined.

David
Schwarz:
We
are
certainly
aware
that
there
are
many
states
that
have
EPA
programs
that
have
been
taking
submissions
on
diskette
or
CD.
And
again,
let
me
stress
that
the
proposed
rule
does
not
apply
to
those
cases.
It
does
not
apply
to
the
submission
on
some
kind
of
mag
medium.
So
I
guess
we
would
be
interested
in
hearing
about
the
cases
you're
aware
of
where
there
is
actual
submission
over
some
kind
of
telecommunications
network.
Because
that's
really
what
the
rule
was
designed
for.

Howard
Kruger:
I
understand
now.

Kathy
Barrowclough:
Kathy
Barrowclough
from
DuPont.
And
this
time
I'm
representing
DuPont
on
this
question,
because
it's
a
follow­
up
to
what
Mr.
Kruger
was
just
talking
about.
The
GPA,

deriving
its
jurisdiction
from
Congress,
mandates
that
EPA
provide
an
option
for
reporting
electronically.
Since
the
intricacies
of
monitoring
the
environment
to
comply
with
Title
V
requirements
are
such
that
this
monitoring
cannot
10
logistically
be
done
manually,
electronic
record­
keeping
and
reporting
in
some
cases
is
not
voluntary.

Officially
some
states,
such
as
Louisiana,
there
was
a
new
proposal
coming
out
in
Louisiana,
where
they're
promulgating
laws
requiring
electronic
reporting,
such
as
Mr.
Kruger
was
speaking
of.
Other
states
such
as
New
Jersey
have
been
accepting
electronic
reporting
for
some
time
now.
Add
to
that
the
nearly
universal
electronic
monitoring
and
record­
keeping
practices
existing
in
the
regulated
environmental
community,

and
the
voluntary
aspect
of
this
proposed
rule
exists
only
in
theory.
And
that's
the
way
we
feel
about
this.
That
it's
not
really
going
to
be
voluntary
for
us
because
we're
already
reporting
electronically
in
many
cases,
and
in
most
cases
keeping
records
electronically.

Once
it's
established
that
the
proposed
rule
is
really
not
voluntary,
then
the
cost
for
purchasing
and
upgrading
systems
to
meet
the
criteria
established
in
CROMERRR
become
a
nonvoluntary
financial
burden
to
regulated
entities.
Therefore,

the
proposed
rule
should
be
evaluated
as
a
requirement
rather
than
a
voluntary
program.

What
plans
does
the
agency
have
for
reevaluating
the
scope
and
burden
of
what
appears
to
the
industry
to
be
a
nonvoluntary
kind
of
rule?

Evi
Huffer:
Just
one
comment,
Kathy,
in
respect
to
the
states.
11
We
do
understand
that
this
could
be
a
potential
problem
for
companies
if
you
have
50
states
doing
one
thing
and
the
federal
government
doing
another.

We
have
over
the
years
worked
extensively
with
the
states,

first
through
a
work
group
called
SEES
and
now
through
ECOS,

which
is
the
Environmental
Council
of
States,
and
also
the
National
Governors
Association.
One
of
the
reasons
behind
this
rule,
one
of
the
purposes
behind
this
rule,
was
to
put
together
some
uniform
framework
that
could
be
used,
not
just
by
EPA,
but
also
the
states
as
we
move
forward
with
electronic
reporting
and
record­
keeping
for
environmental
regulation.

We
are
doing
some
additional
analysis
now
in
light
of
the
comments
we've
received
to
date.
We're
going
back
and
we
will
reevaluate
the
costs.
We're
particularly
interested
in
the
issue
that's
been
brought
up
by
the
industry
about
the
voluntary
nature
of
the
rule.
We
were
unaware
of
extensive
electronic
reporting
going
on
in
the
environmental
community.

And
again,
what
we're
talking
about
are
submissions
over
a
telecommunications
network.
We're
not
talking
about
mag
media
such
as
CDs
or
diskettes.
But
if
in
fact
there
is
extensive
electronic
reporting
going
on
at
the
state
level,
then
we'll
need
to
go
back
and
reevaluate.

Lauren
Freeman:
I
have
a
question
and
then,
I
guess,
a
followup
comment.
12
Evi
Huffer:
Could
you
please
state
your
name?

Lauren
Freeman:
Yes,
my
name
is
Lauren
Freeman,
I'm
with
Hunton
&
Williams
and
I'm
here
representing
utility
regulatory
groups.
And
this
is
on
the
issue
of
the
voluntariness,
and
examples
of
existing
electronic
submission
requirements.
The
utility
industry
is
subject
to
fairly
sophisticated
electronic
submission
requirements
under
40C
of
(
inaudible)
part
75,
the
acid
rain
program.
And
that
is
now
being
extended
under
all
market­
based
trading
programs,
budget
program
(
inaudible).

Those,
that
is
a
mandatory
submission
requirement
for
utilities
and
it's
done
using
actual
EPA
software.

It's
my
understanding
that
this
proposed
rule,
that
Subpart
or
Part
3
would
not
apply
to
programs
like
that
unless
the
rules,
in
this
case
Part
75,
were
actually
revised
to
require
compliance
with
Part
3.
So
if
that
is
not
the
case,

then
I
think
that
needs
to
be
made
clear.
For
example,
you
have
revised
Part
70
to
explicitly
reference
Part
3.
But
other
existing
programs
that
have
electronic
submission
requirements,

that
do
not
currently
reference
Part
3,
it's
my
understanding
that
this
will
now
apply.

Michael
LeDesma:
Well,
when
we
were
drafting
it,
we
intended
to
go
through
and
identify
all
of
the
programs
that
we,

basically
all
of
the
state
programs
where
we
wanted
to
look
for
purpose
and
clarity,
and
for
purposes
of
making
it
explicit,
we
13
wanted
to
make
references
to
Part
3.
We
may
have
forgotten
some
programs.
We
have
a
great
many
programs
out
there
...
in
a
short
period
of
time,
did
our
best
in
terms
of
identifying
the
programs
that
we
thought
would
be
...
we
wanted
to
have
subject
to
the
rule.

If
it
is
generally
true,
however,
that
our
intent
in
structuring
the
rule
was
that
if
there
is
an
ongoing
electronic
reporting
program
in
the
agency,
that
there
is
a
provision
that
it
can
be
carved
out
of
the
scope
of
the
rule.
So
that
we're
not
kind
of
stepping
on
ourselves
in
terms
of
the
electronic
reporting
methods
that
we
plan
to
employ
here.
So
it
may
be
that
this
particular
provision
that
you're
concerned
with,
that
the
particular
program
that
you're
concerned
about,
was
inadvertently
left
out
of
the
rule.
But
if
that's
not
the
case,
and
it
strikes
me
that
it's
probably
likely
that
we
didn't
inadvertently
leave
it
out,
then
it's
certainly
something
...
I
think
it's
certainly
something
that
we
would
want
to
leave
out,
that
we
would
want
to
carve
it
out.
So
I
think
that
in
the
preamble
we've
asked
for
comments
about
provisions
where
it's
currently
unclear
whether
or
not
a
program
is
going
to
be
subject
to
the
rule,
especially
if
there's
already
ongoing
electronic
reporting,
to
make
that
clear
to
us,
so
that
we
make
sure
that
it
gets
in
there,
that
it
does
get
carved
out.
And
we'll
talk
to
the
program,
the
14
folks
that
run
that,
administer
that
program
within
the
agency
to
make
sure
they
do
intend
it
to
be
carved
out.
Have
I
made
myself
clear?

Lauren
Freeman:
I
guess
my
question
then
goes
to,
what
is
the
default?
It's
my
understanding
in
the
reading
of
the
rule
that
unless
Subpart
3
is
specifically
adopted
in
a
rule,
it
would
not
apply.
The
default
would
be
it
would
not
apply
unless
they
were
specifically
adopted
in
a
rule.
Assuming
we're
talking
about
electronic
submission
that
is
required
under
a
rule,
as
opposed
to
somebody
adopting
voluntarily.

Michael
LeDesma:
Are
you
talking
about
adoption
of
a
rule
in
the
future?

Lauren
Freeman:
No,
I'm
talking
about
existing
rules,
existing
rules,
existing
final
rules.
Unless
this
proposal,
or
a
future
proposal,
actually
revises
that
rule
to
incorporate
Part
3,

Part
3
would
not
be
required.
That
is
my
understanding.
And
if
that's
not
clear,
if
that's
not
the
case,
then
I
think
your
proposal
is
unclear.

Michael
LeDesma:
Well
it
may
be
...

Lauren
Freeman:
I
think
the
default
should
be
that
it
does
not
apply
unless
the
agency
or
a
state
or
somebody
specifically
adopts
it.
I
will
submit
written
comments
on
this,
but
I
think
some
of
the
concern
here
in
the
room
may
be
based
on
a
concern
that
Part
3
is
going
to
apply
to
their
program
without
any
15
consideration
of
whether
it's
appropriate.
That
is,
for
the
case
of
required
electronic
submission,
where
you
are
currently
required
to
submit
that
way.

Michael
LeDesma:
When
you
say
program,
are
you
talking
about
a
state
program?
Are
you
talking
about
...

Lauren
Freeman:
Well
the
example
I
gave
was
...

Michael
LeDesma:...
just
a
general
...?

Lauren
Freeman:
The
example
I
gave
was
a
federal
program.
I
think
there
are
also
state
programs
that
do
require
electronic
submission.
Pennsylvania,
for
example,
requires
electronic
submission,
I
believe,
of
real­
time
data,
emissions
data.
And
it
would
be
my
understanding
that
unless
Pennsylvania
said
you
had
to
use
Part
3,
you
had
to
comply
with
that,
you
would
not
have
to.
So
that
...

Michael
LeDesma:
Yeah,
I
think
the
intent
anyway
...
and
if
it's
not
clear,
we'll
need
to
make
it
clear,
is
that
this
rule
would
apply
across
the
agency.
We
wouldn't
want
to
go
through
and
revise,
line
by
line,
every
single
reference
to
electronic
reporting
or
submission
across
several
volumes
of
40
CFR.
So
it
makes
what
is
a
fairly
sweeping
interpretation
of
our
regulations,
so
that
this
would
apply
generally
except
where
there's
an
exclusion.

Lauren
Freeman:
I
guess
that's
why
I'm
saying
that's
the
case
if
you
are
voluntarily
adopting
to
use
this
submission
program.
16
If
you're
not
currently
required
to
make
an
electronic
submission,
and
you're
opting
into
doing
it
voluntarily,
the
regulation
may
or
may
not
have
to
be
revised.
But
if
you
are
under
an
obligation,
under
a
rule
to
submit
electronically
because
a
program
office
or
a
state
has
decided
they
want
you
to
submit
electronically,
that
is
not
voluntary.
That
is
required.
And
it
is
my
understanding
that
in
order
to
apply
Part
3
to
that
required
submission,
it
would
have
to
be
adopted
specifically.

Kathleen
Barrowclough:
This
is
an
existing
electronic
reporting
program.
(
inaudible)

Male
Participant/
EPA:
I
think
we'll
need
to
sort
that
one
out,

but
you
know,
we'll
take
your
comment.

Male
Participant/
EPA:
To
be
clear,
though,
I
think
the
intent
is
that
where
we
have
an
existing
electronic
reporting
system
within
the
agency,
that
we
want
those
folks,
to
the
extent
they
don't
want
to
kind
of
shift
over
from
their
criteria,
we
want
those
folks
in
the
agency
to
tell
us
whether
or
not
they
want
to
be
included
within
the
scope
of
CROMERRR.
Whether
or
not
they
want
these
criteria
to
be
the
ones
that
govern
their
program.

The
difficulty
of
course
is
it's
a
very
large
agency;

there's
a
great
many
programs
and
there
are
programs
that
are
ahead
of
the
curve
in
terms
of
electronic
reporting.
And
if
17
they've
already
gone
forward,
again,
we
don't
want
to
be
stepping
over
their
program,
so
we've
written
provisions
in
here
so
that
they
can
carve
themselves
out.
And
if
they
haven't
done
that,
and
you're
aware
that
they
haven't
done
that,
and
think
that
they
probably
would
want
to,
certainly
it
would
be
good
to
raise
that
point
in
comments
so
that
we
can
go
back
to
those
folks
and
say,
hey,
don't
you
mean
for
yourselves
to
be
carved
out
of
this
rule?

Kathleen
Barrowclough:
As
a
follow­
up
to
that
question,
Kathy
Barrowclough,
DuPont,
one
of
the
concerns
we
have
around
that
particular
aspect
is
the
statement
in
the
preamble
that
until
some
future
date,
when
the
EPA
makes
an
announcement
in
the
Federal
Register
...
I
assume
it
was
the
Federal
Register
...

that
they
are
now
accepting
electronic
reports,
it
sort
of
excludes
you
from
sending
electronic
reports
whereby
they
might
already
be
doing
that.
And
I
think
that
industry's
concerned
you're
putting
a
halt
to
the
things
that
they're
already
doing
because
now
they're
going
to
no
longer
be
able
to
report
electronically.
That
applies
to
record­
keeping,
too,
that
we'll
get
into
later,
but
until
you
publish
in
the
Federal
Register
that
you
are
now
accepting
electronic
reporting,
the
industry
is
reading
that
as
though,
if
we
are
already
reporting
electronically,
we
can
no
longer
do
it
until
we
see
this
in
the
Federal
Register.
So
I
think
it's
a
little
bit
of
a
18
miscommunication,
the
same
way
as
the
previous
speaker.

Michael
LeDesma:
I
think
we
need
to
make
that
clear.
The
intent
is
not
to
stop
ongoing
electronic
reporting.
That
is
part
of
existing
agency
programs.
We
intended
to
have
those
programs
carved
out
of
the
scope
of
the
rule,
unless
that
program
office
decided
for
some
reason
that
they
wanted
to
shift
over
to
the
CROMERRR
approach.
So
to
the
extent
that
hasn't
happened,
and
you're
aware
of
it,
you
can
raise
that
in
your
written
comments
and
your
comments
here
so
that
you
can
make
sure
that
you
have
that
addressed.

Howard
Kruger:
Hi,
this
will
be
my
last
time
on
this
one.
I'm
Howard
Kruger
from
Proctor
and
Gamble.
I
tried
to
get
at
the
same
point
that
Ms.
Barrowclough
made,
although
she
did
it
much
more
eloquently
and
clearly
than
I
did.
I
tried
to
get
at
it
when
I
read
you
from
the
preamble
where
you
say
you
will
allow
it.
And
then
I
made
the
statement
that
this
is
confusing
because
there's
a
massive
electronic
reporting
that's
going
on.

So
I
just
wanted
to
second
her
comment,
and
the
clarity
that
she
brought
to
the
issue.

I
have
two
other
things
that
I
would
like
to
bring
to
your
attention.
This
gentleman
here
alerted
me
that
there
are
some
things
that
were
not
applicable,
reporting
on
CDs
and
mags.

The
thing
that
I
want
to
make
sure
that
you
understand
is
there
are,
and
I
will
use
advisedly
hundreds
of
thousands,
and
this
19
is
a
catch
22,
hundreds
of
thousands
of
companies
...
let's
say
reporting
entities
that
are
keeping
records
electronically
on
existing
equipment,
that
would
be
used
to
verify
that
you
had
not
met
a
threshold
for
reporting,
irrespective
of
whether
you're
reporting
telecommunications,
on
magnetic
tape
or
on
CD.

So
there
are
...
this
is
the
catch
22
where
regardless
of
exclusions
you
make,
you're
going
to
have
to
somehow
come
to
grips
with
this
reach
over
to
record­
keeping
that
people
are
now
using
in
current
systems.

And
then
the
other
question,
I
would
just
like
to
hear
you
talk
a
little
bit
about,
is
how
is
EPA
going
to,
with
all
the
huge
numbers
of
systems
that
you
have,
are
you
going
to
come
into
compliance
with
this
rule,
from
a
standpoint
of
these
requirements?

Joe
Retzer:
I'm
not
sure
I
quite
understand
that
last
qestion,

but
I
think
if
you
look
at
the
Central
Data
Exchange,
the
idea
is
that
EPA,
at
moving
towards
having
all
direct
reporting
coming
to
EPA,
come
through
one
place,
one
web
portal.
And
that
portal
will
be
designed
to
meet
the
reporting
requirements
that
are
in
this
rule.
And
that's
why,
for
example,
on
things
like
the
acid
rain
program,
for
awhile
that
program
may
continue
its
reporting
as
it
is.
But
it
may
eventually
shift
over
to
Central
Data
Exchange,
as
other
programs
are
doing,
as
well.
20
Howard
Kruger:
Even
though
you
have
CDX,
you're
going
to
still
have
states
to
whom
you
delegate
and
move
us?

Joe
Retzer:
That's
correct.

Howard
Kruger:
Okay,
well
how
will
...
I
mean,
I
consider
that
part
of
your
responsibility.

Joe
Retzer:
Right.

Howard
Kruger:
How
will
you
comply
with
the
rule?
How
will
your
delegated
entities
...
if
I
go
out
and
hire
a
contractor
for
an
...

Joe
Retzer:
Are
you
asking
how
will
the
states
comply
with
this?

Howard
Kruger:
No,
I'm
asking
how
will
you?
How
will
the
...

you're
delegating
the
states.
I
hold
you
accountable.
Not
the
states,
you.
The
EPA
of
the
United
States
of
America.

Joe
Retzer:
So
the
question
for
us
is
how
do
we
hold
the
states
accountable?

Howard
Kruger:
Yes.
When
they
don't
have
the
CDX
and
all
these
other
kinds
of
fancy
things.

Joe
Retzer:
Well,
we
will
...

Howard
Kruger:
I'm
saying
this
to
you
...

Joe
Retzer:
We
will
be
addressing,
we'll
be
talking
about
that,
I
think,
later
this
afternoon.
But
we
do
have
the
criteria
applied
to
states
and
EPA
needs
to
approve
the
state
systems.
21
Howard
Kruger:
Okay,
well
we
always
need
to
remember
that
in
order
for
a
compliance
system
to
be
in
existence
that
someone
has
to
budget
the
money,
collect
the
money,
dedicate
the
money,

spend
the
money,
actually
spend
it
on
equipment
that
will
allow
for
a
compliance.
These
are
real;
you
can't
just
do
it
theoretically.
It
has
to
be
real
life,
real
time.

David
Schwarz:
Yeah,
one
of
the
things
I
guess
to
kind
of
keep
in
mind
in
our
thinking
about
this
rule
is
that
EPA
is
designing
and
is
building
and
actually
has
started
receiving
reports
through
something
called
the
Central
Data
Exchange.

The
idea
here
is
that
direct
reports
to
EPA,
as
well
as
batches
of
files
from
states,
are
going
to
be
coming
through
one
portal
at
EPA.
And
since
we'll
be
having
one
face,
the
idea
is
that
we
need
a
sort
of
standard
set
of
approaches
or
standard
set
of
requirements
that
should
make
it
easier
on
companies
not
having
to
deal
with
ten
or
twelve
or
fifteen
different
programs
for
direct
reporting.

And
we've
already
started
a
couple
of
programs
now,
one
with
direct
reporting
from
laboratories
under
the
unregulated
contaminants
rule,
in
the
drinking
water
program.
We've
also
had
some
talks
with
release
inventory
reports,
come
directly
to
EPA
through
Central
Data
Exchange.
Now
we're
working
on
a
couple
of
areas
under
COSCO
(
phonetic)
like
health
and
safety
studies,
as
well.
22
So
the
idea
is,
we're
going
to
have
a
sort
of
standard
approach
to
electronic
reporting
and
registration
for
companies
doing
direct
reporting
to
EPA.
We've
got
this
underway
now;

we've
been
working
with
an
interim
facility
at
this
time.
And
we're
going
to
have
our
procurement
underway
to
have
a
fullfledged
fully
operational
Central
Data
Exchange
up
and
running
late
next
year.

And
part
of
the
idea
of
this
sort
of
announcing
that
we're
ready,
that
EPA
is
turning
on
electronic
reporting
program
by
program,
is
based
on
the
idea
that
we
have
to
get
ready,
have
to
do
the
work,
have
to
have
the
hardware
and
software
in
place
for
each
program
to
be
able
to
say,
okay,
we're
ready
to
receive
electronic
reporting.
The
idea
there
wasn't
to
prevent
or
stymie
electronic
reporting
that's
going
on
now.
The
idea
was
simply
to
say,
you
know,
we're
not
going
to
be
ready
to
receive
electronic
reporting
all
at
once.

We're
going
to
be
turning
on
programs
one
after
the
other
when
we're
ready
to
receive
them.
But
we
don't
want
people
willy­
nilly
sending
us
email
saying
here's
my
electronic
report
until
we're
really
ready
to
receive
them.

Evi
Huffer:
Are
there
any
questions
or
comments
on
the
Central
Data
Exchange?

Bill
Barta:
Bill
Barta
from
FMC
Corporation.
I
have
two
questions.
There's
a
revision
in
the
rule
about
upgrades
in
23
the
CDX
system,
major
and
minor.
And
I
have
two
comments
on
that.
First
of
all,
I
think
you
need
to
define
a
little
more
definitely
what
that
exactly
means
to
the
user
group.
And
secondly
was,
we
felt
within
our
IT
group
in
FMC
that
the
lead
time
for
the
major
was
probably
insufficient.
We
thought
maybe
another
six
months
or
a
year
because
of
the
budgeting
process
within
the
corporation.
We'd
need
some
extra
lead
time.
I
think
that
was
a
12­
month
target
to
meet
the
format.

And
the
reason
we
mention
that
is
that
typically
something
is
done
in
June,
for
example,
we
have
budget
process
...
October,

November
an
actual
(
inaudible)
probably
would
take
longer
than
that
because
of
our
cycle
within
the
company.
I
think
many
other
companies
would
be
in
that
same
situation.
So
I
think
maybe
you
might
want
to
consider
that
time
frame
to
discuss
with
the
clients.

The
second
feature
that
was
brought
to
my
attention
was
how
long
are
you
going
to
keep
records
electronically
on
CDX?

There
are
programs
that
might
have
a
pretty
long
retention
time
and
I
imagine
that
you
might
want
...
at
some
point
in
time,

when
something
is
out
there
five
to
seven
years,
you're
probably
going
to
have
to
migrate
to
another
system,
and
if
you
did
that,
how
would
you
coordinate
that
with
the
submitter
who
probably
would
be
in
the
same
situation.
And
if
the
agency
used
a
different
migration
path
than
the
submitter,
we
24
potentially
could
have
a
disparate
record
that
potentially
could
not
match,
depending
on
what
kind
of
software,
hardware.

David
Schwarz:
Can
I
ask
you
a
question?
Are
you
referring
specifically
to
what
we
call
a
copy
of
record?

Bill
Barta:
Yes.
Well,
could
you
explain
more
about
the
copy
of
record
because
I
had
some
uncertainty
about
what
that
means.

David
Schwarz:
Well
that
is
the
submission
with
the
electronic
signature,
signed
over
again
by
the
agent
...
well,
by
what
in
effect
would
be
an
agency
electronic
signature.
And
that
would
sort
of
serve
as
the
surrogate
for
the
paper,
originally,
which
of
course
we
won't
have
because
there
won't
be
any
paper.
And
in
the
rule,
we've
talked
about
making
that
available
to
the
submitter.
And
it
sounds
like
what
you're
saying
is
that
if
we
migrate
the
way
we
keep
our
copy
of
record,
we
might
want
to
make
the
migrated
version
available
to
the
submitter.

Bill
Barta:
Okay,
okay.

David
Schwarz:
That's
a
good
point.
I
hadn't
even
thought
about
that.

Evi
Huffer:
Were
you
through
with
your
comments?

Bill
Barta:
Oh,
sure.

George
Britton:
George
Britton
with
the
Aventis
Crop
Science.

It
is
very
likely
in
migration
scenarios
that
migrating
upward
may
not
generate
exactly
the
same
information
that
you
had
previously.
And
if
you
are
like
software
updates,
people
don't
25
always
upgrade
Windows
at
the
same
rate
as
everybody
else
...

there
are
things
and
features
in
the
new
version
that
will
not
be
available
backwards.
So
if
you're
submitting
backwards,

there's
a
problem
there
with
having
information
come
back
to
whoever
submitted
it,
if
you're
on
different
operating
systems,

for
example.
That's
where
the
migration
issues
...

David
Schwarz:
Right,
right.

George
Britton:
...
and
technology
has
changed
so
dramatically
in
the
last
five
years.
When
was
the
last
time
you
read
a
five­
and­
a­
quarter
floppy
or
eight­
inch
floppy?

David
Schwarz:
Right,
right.

George
Brittin:
Those
kinds
of
issues
in
migration.

David
Schwarz:
Yes.
We
would
welcome
any
suggestions
that
people
have
in
terms
of
how
best
to
handle
these
kinds
of
issues.

Mary
Catherine
Fish:
My
name
is
Mary
Catherine
Fish,
and
I'm
with
MCF
Consulting,
Inc.
and
I
had
a
question
that
went
back
to
some
of
the
earlier
discussion
about
the
lists
of
subjects
and
the
parts
that
are
affected.
You
mentioned
that,
in
terms
of
reports
that
are
already
beginning
to
come
through
CDX,
TRI
and
TSCA.
I
had
noticed
that
those
are
two
parts
that
are
not
listed
in
the
list
of
subjects
in
the
regulatory
language.

There's
not
a
listing
of
Part
370
or
Part
700.

So
I'm
confused
about
what
it
means,
what
is
the
26
difference
between
those
that
are
specifically
listed
and
Part
70,
etcetera,
and
those
that
are
not.
And
I
think
to
reiterate
the
previous
question,
if
they're
not
listed,
is
the
default
that
they
are
affected?
Or
that
Part
3
is
applicable?
And
why
were
some
listed
and
have
proposed
regulatory
language
and
others,
like
Part
700
or
Part
370,
not
included
in
the
list
of
subjects
for
the
proposed
rule?
It's
confusing
as
to
what
the
reporting
requirements
will
apply
to.

Evi
Huffer:
Right,
and
I
think
I
can
see
a
need
for
clarification
here.
And
this
follows
up
on
your
comment
earlier.
What
you
see
listed
in
the
Federal
Register,
it
says
40
CFR
Parts
3,
51,
60,
63
...
those
program
sites
refer
to
specific
provisions
for
the
state
privacy
regulations
and
they're
not
...

Evi
Huffer:
...
clarify
(
inaudible)

Male
Participant:
(
inaudible)

Evi
Huffer:
In
the
Federal
Register
notice,
at
the
top
of
the
notice,
it
says
"
What
parts
are
affected
by
the
proposed
rule?"

46162.
I
assume
when
people
are
stepping
to
the
mike
a
referencing
sections
that
aren't
being
referred
to
in
the
rule,

they're
referring
to
this,
to
parts
that
are
specifically
sited.
Again,
these
parts
are
specifically
sited
because
they're
regulatory
language
is
being
changed
under
their
state
program
positions.
27
Michael
LeDesma:
I
think
again
that
the
answer
is
that
unless
a
state
...
unless
one
of
our
programs
has
explicitly
opted
itself
out
of
CROMERRR,
the
default
is
that
a
program
would
be
affected
by
CROMERRR,
would
be
covered
by
CROMERRR.

Kathleen
Barrowclough:
Kathy
Barrowclough,
DuPont.
And
this
is
a
follow­
up,
when
you
were
talking
about
the
copy
of
record
and
it
being
maintained
by
EPA.
It
seems
to
me
that
I
at
least
interpreted
what
I
was
reading
to
mean
that
this
copy
of
record
would
be
sent
back
and
that
we,
as
the
industry,
who
had
submitted
it
originally
would
be
required
to
keep
the
one
that
we
sent
as
well
as
the
copy
of
record
that
was
returned
from
EPA
so
that
we
would
be
archiving
all
of
that.
It
didn't
sound
that
way
based
on
what
you
said
a
few
minutes
ago.
Could
you
sort
of
clarify
that?

David
Schwarz:
I'll
try.
There
is
no
requirement
in
CROMERRR
that
the
submitter
maintain
what
we're
calling
the
copy
of
record.
We're
not
adding
any
new
record­
keeping
requirements
in
that
area,
so
what
we
say
is
that
we
will
make
this
available
to
you.
You
can
take
it
or
not,
as
you
choose.

Kathleen
Barrowclough:
And
again,
on
one
of
the
other
areas
that
we've
just
talked
about,
where
the
certification
and
the
electronic
signature
certification
aspect
in
particular.
One
of
the
concerns
that
I
have
heard
raised
is
how
quickly
people
will
be
able
to
receive
that
certification.
For
example,
there
28
are
changes
in
personnel
that
occur
and
we
don't
want
to
impede
our
ability
to
report
electronically
because
of
those
sorts
of
things.
So
we
would
like
to
make
certain
that
it's
going
to
be
a
very
quick
turnaround
on
the
certification
scenario.

And
two,
in
I
believe
the
ICR
that
was
submitted
on
the
cost
benefit
analysis,
it
appeared
that
there
were
very
few,

maybe
like
two
people
per
facility
that
might
be
needing
to
get
this
certification.
And
it
is
our,
within
DuPont,
we
have
many
more
people
than
that
who
submit
electronically
and
would
need
to
be
registering.
So
that
number
is
greatly,
very
much
larger
than
what
we
read
in
the
ICR.
So
those
are
two
points,
if
you
would.

David
Schwarz:
Well,
the
second
point,
I
mean,
we'll
obviously
...
any
information
that
you
could
give
us
on
that
would
be
of
interest
and
we'll
take
it
into
account.

I
guess
with
regard
to
the
first,
by
the
certification,
I
assume
you're
talking
about
the
registration
with
CDX
and
the
assignment
provision
of
a
signature
mechanism.
Right?
Our
hope
is
that
that
can
be
fairly
quick.
It
can
be
done
pretty
much
online.
I
guess
in
our
current
prototype,
the
turnaround
is
less
than
a
week.
I'm
kind
of
looking
at
a
colleague
in
the
back.
Kim,
is
that
right?

Kim
Nelson:
(
inaudible)

David
Schwarz:
Three
or
four
days,
something
like
that.
So
29
hopefully
that
would
be
timely.

Lauren
Freeman:
Again
Lauren
Freeman
with
Hunton
and
Williams.

And
I
have
a
follow­
up
question
to
this
applicability
to
existing
programs
and
existing
electronic
submission
requirements,
for
example
Part
75,
you
explained
you
thought
that
this
program
would
apply
when
finalized
to
that,
unless
other
subparts
were
carved
out.
What
procedure
do
you
envision
that
carve­
out
to
be
accomplished
through?
And
did
you
account
in
your
ICR
and
other
burden
estimation
requirements,
did
you
take
into
account
the
burdens
associated
with
requiring
other
programs
to
convert
to
this
subpart?

David
Schwarz:
The
ICR
addresses
burden
on
the
public.
It
doesn't
address
...

Lauren
Freeman:
The
burden
of
the
regulated
entity
...

David
Schwarz:
I
see.

Lauren
Freeman:
...
that
is
making
a
submission
under
an
existing
program.
If
this
applies,
unless
that
is
then
separately
carved
out,
what
mechanism
would
you
carve
it
out
in,
and
did
you
consider
the
impact
of
hundreds
of
electrical
utilities,
for
example,
having
to
come
up
with
systems
that
meet
Part
3?

David
Schwarz:
I
guess
the
answer
to
the
burden
question
is
that
we
did
not
consider
that,
and
probably
ought
to.
But
I
guess
in
terms
of
carving
out,
again,
to
echo
what
Michael
30
LeDesma
said,
hopefully
in
your
comment,
you
will
be
able
to
alert
us
to
areas
that
we
missed.
We
may
need
to
go
back
to
our
programs
and
ask
them
if
they
wish
to
be
covered
or
not,

and
probably
in
a
number
of
cases,
at
least
in
the
short
term,

programs
would
wish
to
continue
under
their
existing
system.

And
we
can
reflect
that
in
final
rule.
There
is
a
place
for
a
list
of
exempted
programs
or
excluded
programs.
So
that
would
be
the
mechanism
there.

Joe
Retzer:
I
also
think
if
we
were
to
bring
in
a
program
like
the
acid
rain
program
that
the
only
really
change
for
the
company
...
you
wouldn't
be
changing
the
software
or
the
file
structure
or
anything
of
that
sort.
The
only
change
would
be
how
the
registration
would
work.
I
don't
know
exactly
how
that
program
works
now,
whether
you
dial
up,
whether
it's
an
FIFRA
(??)
or
whatever,
but
under
CDX
you
come
through
a
website
(
inaudible)
web­
based
(
inaudible)
system
or
not.
But
the
idea,

for
example,
what
we've
done
in
working
with
TRI,
our
TRI
reporters,
is
that
we
haven't
changed
the
TRI
software
at
all.

What
we
did
is
just
simply
provide
people
an
option
to
go
to
a
website
and
send
electronically
instead
of
either
printing
it
out
or
mailing
a
diskette.
And
what
we're
doing
with
the
new
to
try
the
TRI
version
that's
coming
out
next
year,
is
being
built
into
the
CDX
just
like
on
Turbo
Tax
you
can
say,
yeah,
I
want
to
send
this
electronically
and
follow
a
couple
of
31
instructions
and
send
it
electronically.
That's
what
will
happen
with
TRI.

So
what
we're
trying
to
do
is
we're
putting
in,

particularly,
you
know
we
haven't
worked
with
...
the
reason
we
haven't
done
acid
rain
yet
is
that
it's
already
going
electronic
and
we're
more
concerned
with
bringing
in
the
programs
that
are
not
electronic
now
to
provide
that
opportunity.
But
at
some
point,
if
we
decide
to
work
with
the
acid
rain
program,
and
they
say,
yeah,
great,
and
come
through
Central
Data
Exchange,
basically
the
idea
would
be
to
make
it
as
seamless
as
possible.
The
only
thing
that
would
probably
change
would
be
how
the
registration
would
work.

Lauren
Freeman:
Again,
Lauren
Freeman
with
Hunton
and
Williams.
Let
me
just
explain
why
I'm
so
concerned
about
the
applicability.
It's
not
necessarily
the
registration
process
or
whether
you're
doing
it
through
a
website
or
through
the
existing
software
that
EPA
provides
utilities.
My
concern
is
with
some
of
the
other
requirements.
For
example,
the
signature
verification
requirements,
the
requirement
that
the
report
actually
be
physically
submitted
by
the
person
who
signs
it,
which
in
many
cases
is
a
vice
president
or
somebody
who
is
not
...
and
also
the
requirement
that
you
re­
back
data.
We're
talking
about
three
months
of
hourly
data
for
dozens
of
parameters.
You
can't
physically
read
that
on
a
screen.
So
32
I'll
save
my
comments
for
later,
but
if
those
...

Male
Participant/
EPA:
So
one
thing
that
might
be
really
helpful
is
if
you
think
about
your
company
being
eventually
part
of
the
CDX
structure,
what
are
the
particular
requirements
like
that
one,
that
you
think
would
be
a
problem?

Lauren
Freeman:
Well,
we're
trying
to
decide
how
much
we
have
to
comment
on
this
program
by
determining
whether
or
not
we'll
be
affected
by
it,
and
whether
we'll
get
another
chance
to
comment
on
it.

Male
Participant/
EPA:
I
guess
eventually
the
agency
is
thinking
that
direct
...
all
the
direct
reporting
will
be
done
through
Central
Data
Exchange.
Simplify
security,
simplify
registration.
Should
eventually
simplify
for
companies
because
they'll
have
one
place,
one
system
on
the
(
inaudible)
to
send
data.
Since
that's
the
program
already
sending
stuff
electronically,
it's
not
on
the
top
of
our
list
of
programs
to
bring
in.
But
I
guess
I
would
say
yes,
you
should
pay
attention
to
it,
because
probably
eventually
you're
going
to
connect
with
CDX.
So
it
would
be
worthwhile
to
make
comments
on
the
reporting
aspects,
such
as
viewing
the
data
before
you
send
it
in.

Lauren
Freeman:
All
right.
Thank
you.

Kathleen
Barrowclough:
Kathy
Barrowclough,
DuPont.
And
following
up
what
Lauren
just
mentioned
about
the
person
who
is
33
submitting
not
always
being
the
person
...
we
delegate
authority
within
DuPont.
So
that
while
it
might
be
a
vice
president's
name,
it
might
be
delegated
for
someone
else
to
actually
be
doing
that
submission.
So
it
makes
us
believe
that
there's
going
to
be
a
more
complex
process
that's
going
to
be
associated
with
that
registration
...
submitter
registration
process.
Do
we
have
to
register
all
of
the
people
who
need,

who
touch
that
document,
or
do
we
need
to
just,
the
person
who
we
have
delegated
as
the
person
who
submits?

David
Schwarz:
I
think
our
intention
is
that
the
person
who
submits,
signs
and
certifies
is
the
person
who
gets
registered,

gets
the
electronic
signature
device.
If
there's
something
wrong
with
that
idea,
then
we
need
to
know
about
it.

Kathleen
Barrowclough:
Again,
you
answered
my
question.
Again,

one
of
the
concerns
that
I
might
have,
having
come
here
today
and
hearing
some
of
the
clarifications
you're
giving,
and
some
of
the
comments
you
would
like
to
see
around
certain
things,

such
as
when
we
say
we
see
this
part,
this
part
and
this
part
mentioned,
what
does
that
mean
for
the
others
...
is
that
the
people
who
are
not
aware
of
that
will
probably
submit
comments
just
saying
please
clarify
this.
And
once
you've
clarified
that,
then
they
may
have
those
other
comments
that
you're
asking
for
us
to
do,
to
give
to
you.
So
I
guess
I'm
concerned
that
the
entire
regulated
community
won't
be
aware
of
some
of
34
the
comments
that
they
need
to
submit,
based
on
what
we
just
have
heard
from
you.

David
Schwarz:
I
guess
to
the
extent
that
it
seems
that
that's
a
widespread
...
that
the
confusion
is
widespread,
we'll
need
to
consider
how
to
rectify
that.

Michael
LeDesma:
We
certainly
don't
want
to,
we
don't
want
people
not
to
be
commenting,
or
commenting
completely
that
they
misunderstand
the
language.
On
the
other
hand,
we
don't
want
to
get
into
this
endless
do­
loop,
where
we
get
questions,

comments,
that
we
need
to
clarify.
That
would
not
be
productive.

Howard
Kruger:
Hi,
Howard
Kruger
from
Proctor
and
Gamble.
I
would
just
like
to
second
...
sometimes
what
we're
doing
here
is
we're
saying
"
yes,
yes,
yes."
I
would
like
to
second
the
comment
that
was
just
made
by
Ms.
Fair
about
once
you
clarify
some
things
that
are
not
understood,
and
a
lot
is
not
understood
about
the
CDX.
When
you
start
to
read
through
the
proposal,
several
things
jump
out
like,
yes,
there's
going
to
be
signatures,
electronic
signatures.
Yes,
there's
electronic
reporting.
Yes,
there's
electronic
record­
keeping.
But
then
there's
this
mysterious
page
after
page
about
CDX,
and
I
would
just
volunteer
...
or
I'll
say,
from
my
standpoint,
that's
the
least
understood
part
of
the
proposal.
And
so
when
you
do
make
clarifications,
then
maybe
I
can
be
a
little
smarter
to
begin
35
to
make
some
comments
to
be
helpful.
But
right
now,
I
would
say
that's
sort
of
a
black
box,
and
that
if
you
don't
get
a
lot
of
comments,
I
think
you
should
not
assume
that
everything's
hunky­
dory,
but
that
people
are
really
confused
by
this
and
they
don't
understand
it.

(
BREAK)

Kathleen
Barrowclough:
Kathy
Barrowclough,
DuPont.
One
of
the
questions
that
we've
come
up
with
is
about,
will
the
Department
of
Energy
and
the
Department
of
Defense,
their
massive
remediation
sites
and
that
sort
of
thing
...
will
they
have
to
follow
this
requirement
for
either
reporting
or
record­
keeping?

David
Schwarz:
I
was
going
to
defer
to
my
colleague
as
general
counsel,
but
my
understanding
is
that,
to
the
extent
that
they
are
a
regulated
entity,
they
would
have
to
comply.
Yes.

George
Britton:
George
Britton
of
Aventis
Crop
Science.
In
terms
of
the
CDX,
I
represent
the
(
inaudible)
side
of
it
for
Venice
Crop
Science.
And
I
am
concerned
that
our
pesticide
registrations
are
generally
significantly
larger
than
a
few
pages
of
numbers.
And
how
is
the
CDX
planning
to
address
electronic
submissions
of
the
pesticide
registration
process?

Joe
Retzer:
We
may
not.
That
is,
to
the
extent
that
people
are
sending
basically
CDs
and
not
electronic
files
over
a
network.
And
Central
Data
Exchange
and
CROMERRR
don't
apply.

And
if,
you
know,
continuing
discussions
with
that
program,
if
36
that
seems
to
be
the
most
efficient
way
to
continue
doing
that
business,
then
...

George
Britton:
Are
you
saying
that
CROMERRR
does
not
apply?

Joe
Retzer:
CROMERRR
doesn't,
as
we
mentioned,
CROMERRR
does
not
apply
to
data
submitted
on
magnetic
media,
that
is
data
that
doesn't
come
over
a
network.
Data
submitted
on
a
CD
or
data
submitted
on
a
diskette,
or
something
of
that
sort,
or
a
tape
if
you
had
...
CROMERRR
does
not
apply.

Evi
Huffer:
Let
me
add
to
that.
One
thing
to
bear
in
mind
is
that
this
is
an
omnibus
rule.
CROMERRR,
in
itself,
when
promulgated,
does
not
turn
on
electronic
reporting
for
any
program
in
particular.
One
of
the
requirements
for
electronic
reporting
that's
stipulated
under
Subpart
A,
is
that
the
agency
has
to
announce
that
it's
ready
to
accept
electronic
reports
under
a
particular
program.

George
Britton:
Over
a
network.

Evi
Huffer:
Yes,
over
a
network.
So
the
issue
of
having
to
exempt
specific
programs
may
be
moot.
Basically
it
may
be
that,
for
programs
such
as
the
acid
rain
program
that
already
has
an
electronic
reporting
program
in
place,
the
program
will
just
continue
with
that
and
you'll
never
see
an
announcement
that
says
you
will
now
use
CDX.
I
mean,
the
way
the
rule
is
structured,
there
is
a
turn­
on
feature.

George
Britton:
This
may
be
the
follow­
up
to
that.
But
isn't
37
the
rule,
it
talks
about
things
being
modified,
maintained,

distributed
or
reported
electronically
...
like
all
the
businesses
are
in
fact
doing
various
phases
of
that
electronically
already.
And
doesn't
that
make
the
reporting
on
media
mute,
and
make
it
mandatory
at
that
point?

Male
Participant/
EPA:
It
may
...
this
is
actually
something
that
we'll
talk
about
under
the
electronic
recordkeeping
part
of
the
meeting.
But
it
may
bring
them
within
the
scope
of
the
electronic
record­
keeping
portion
of
CROMERRR.

But
it
would
not
necessarily
bring
it
under
the
scope
of
the
electronic
reporting
part
of
CROMERRR.

Evi
Huffer:
Something
that
has
been
brought
to
our
attention,

and
that
we
will
probably
have
to
deal
with
in
the
final
rule
...
it
was
not
intended
to
include
records
or
reports
under
the
definition
`
electronic'
just
because
they
were
created
on
a
PC.

For
instance,
the
FDA
rule
has
a
typewriter
exemption.
When
the
PC
is
used
as
a
typewriter
to
create
documents,
it's
not
intended
to
necessarily
fall
within
the
scope
of
the
electronic
record.

George
Britton:
There's
some
issues
in
that
vein
about
when
does
a
record
become
subject
to
that
rule?
It's
still
up
in
the
air
four
years
after
it's
propagated.

Bob
Bessette:
I'm
Bob
Bessette
with
the
Council
of
Industrial
Boiler
Owners.
We
represent
energy
and
environmental
issues
38
for
most
of
the
boiler
owners
in
the
country.
Are
you
guys
going
to
use
the
FDA
interpretation
of
electronic
recordkeeping
and
reporting
requirements.
Or
if
you're
not
going
to
do
that,
how
are
you
not
going
to
do
it?
It
puts
an
onerous
burden;
there's
not
one
...
I
don't
think
there's
one
industrial
boiler
in
the
country
that
goes
back
and
uses
paper
anymore
to
collect
data.
And
these
are
small
businesses.

These
go
from
little
bitty
boilers,
all
the
way
up.
And
they're
all
sources
that
are
regulated.
If
they're
forced
into
adding
your
implementation
requirements,
there
is
no
cost
benefit.

Right
now
they're
using
the
electronic
medium,
laptops,

they're
using
small
PCs
to
handle
a
lot
of
the
data.
If
they
have
to
go
to
major
record
tagging
stuff,
it's
going
to
raise
the
cost
so
much
that
they're
probably
going
to
want
to
go
back
to
paper.
But
if
they're
using
electronic
now,
they're
doing
...
because
it's
less
expensive
than
using
paper.
So
it's
going
to
add
a
significant
burden
to
22,000
potential
boilers.

If
you're
not
going
to
use
the
FDA's
interpretation,
and
we
can
keep
the
record­
keeping
and
reporting
just
the
way
it
is
today,

then
the
overall
attentiveness
is
very
very
good.
But
if
it's
going
to
go
to
that
next
step,
it's
a
killer.

Mark
Duvall:
My
name
is
Mark
Duvall.
I'm
with
the
Dow
Chemical
Company.
I
had
several
points
that
I
wanted
to
make
39
about
the
record­
keeping
proposal,
record­
keeping
aspects
of
CROMERRR.
The
first
and
the
most
important
one
of
which
is
that
record­
keeping
is
presented
in
the
preamble
as
voluntary,

but
our
analysis
is
that
it
would
be
mandatory
in
practical
effect.
The
reason
for
this
is
that
the
definition
of
an
electronic
record
is
very
encompassing.
It
captures
any
data
that
runs
through
a
computer
at
any
point
in
its
lifetime.
If
it
is
created
on
a
computer,
if
it
is
maintained
on
a
computer,

if
it
is
manipulated
on
a
computer,
if
it
is
stored
on
a
computer,
then
it's
an
electronic
record.
And
anything,

anytime
a
computer
is
involved
with
data,
it's
an
electronic
record.

Once
it
becomes
an
electronic
record,
then
it
is
subject
to
the
rule
if
that
data
is
used
in
connection
with
electronic
record­
keeping,
in
connection
with
record­
keeping
for
EPA
purposes.
And
today,
every
facility
in
the
United
States
that
is
regulated,
has
record­
keeping
responsibilities
under
EPA
requirements,
keeps
those
records
electronically
using
a
computer.
As
a
result,
there
is
no
choice
about
choosing
to
keep
records
electronically.
There
is
only
the
fact
that
everyone
does
and
everyone
must
keep
records
electronically.

So
the
fact
that
this
is
not
a
voluntary
provision
at
all
is
very
significant.
It's
the
most
significant
misperception
about
this
rule,
this
proposal.
40
There
are
a
number
of
consequences
that
come
from
the
fact
that
it
is
not
voluntary,
one
of
which
is
public
notice.
Under
the
Administrative
Procedure
Act,
there
is
a
requirement
that
EPA
give
public
notice
of
what
it
proposes
to
do.
The
public
notice
on
CROMERRR
announced
that
the
record­
keeping
provisions
were
voluntary.
If
you've
read
through
the
notice,
it
said
that
about
428
facilities
per
year
would
choose
to
subject
themselves
to
the
record­
keeping
provisions.
And
yet
approximately
1.2
million
facilities
in
the
United
States
would
be
subject
on
a
mandatory
basis
to
CROMERRR's
record­
keeping
provisions.
There's
a
world
of
difference.
The
public
notice
that
was
provided
to
the
public
by
EPA
is
terribly
deficient.

And
I
think
EPA
should
be
concerned
about
the
prospects
of
a
procedural
objection
on
judicial
review
that
the
public
has
not
had
an
adequate
opportunity
to
comment
because
of
the
way
the
record­
keeping
provisions
have
been
presented.

Third,
my
next
point
is
that
because
EPA
considered
the
record­
keeping
provisions
to
be
voluntary,
it
chose
not
to
conduct
a
regulatory
flexibility
analysis
to
discuss
the
impact
of
CROMERRR
on
small
businesses.
In
fact,
the
preamble
says
that
this
would
have
a
net
benefit
for
small
businesses.
And
yet,
small
businesses
would
be
affected
by
the
record­
keeping
provisions
just
as
big
ones
would
be.
And
they
would
have
to
go
out
and
they
would
have
to
buy
expensive
retro­
fitting
fixes
41
for
their
computer
systems.
Or
they
would
have
to
go
out
and
buy
new
computer
systems
that
would
meet
the
CROMERRR
requirements.
A
huge
impact
on
small
businesses
which
is
not
addressed
by
EPA
because
it
did
not
conduct
regulatory
flexibility
analysis.
So
I
would
strongly
encourage
EPA
to
go
do
one.

Next,
EPA
has
not
justified
the
costs
of
CROMERRR,
given
that
it
is,
in
fact,
a
mandatory
program.
The
regulatory,
I'm
sorry,
the
cost
benefit
analysis
conducted
for
EPA
and
discussed
in
the
preamble
indicates
the
costs
of
the
recordkeeping
provisions
exceed
the
benefits.
Now,
having
a
regulatory
proposal
where
the
costs
exceed
the
benefits
might
make
sense
if
it
were
a
voluntary
program.
But
it's
not.
And
accordingly,
EPA
has
not
justified
the
costs
of
the
recordkeeping
program.

Just
as
we
heard
some
concerns
already
about
how
currently
there
is
ongoing
reporting,
electronic
reporting,
obviously
there
is
ongoing
electronic
record­
keeping
today.
And
yet,

CROMERRR
says
that
there
would
be
no
allowable
electronic
record­
keeping
until
EPA
published
a
notice
in
the
Federal
Register
that
it
was
prepared
to
accept
electronic
recordkeeping
What
that
means
is
that
the
36
EPA
regulations
which
today
currently
allow
explicitly
electronic
record­
keeping,
and
the
many
more
EPA
record­
keeping
provisions
which
implicitly
42
allow
electronic
record­
keeping
by
being
media­
neutral,
would
be
suspended
and
instead
would
have
to
wait.
People
could
not
use
computers
until
EPA
published
a
notice
saying
that
they
could
begin
to
do
so.
The
reason
for
the
notice
that
EPA's
prepared
to
allow
electronic
record­
keeping
is
entirely
unclear,
since
EPA
itself
does
not
have
to
do
any
preparation
for
electronic
record­
keeping
by
the
regulated
entities.

Next,
CROMERRR's
record­
keeping
provisions
would
be
inconsistent
with
the
Government
Paperwork
Elimination
Act
because
they
would
treat
electronic
records
less
favorably
than
paper
records,
contrary
to
the
purposes
of
the
statute,
and
would
actually
discourage
electronic
record­
keeping.
EPA
adopted
CROMERRR,
or
proposed
CROMERRR,
in
large
part
because
of
the
Government
Paperwork
Elimination
Act
which,
among
other
things,
directs
agencies
to
make
available
electronic
reporting
and
electronic
record­
keeping
by
October
2003.
Electronic
reporting
is
not
currently
allowed
in
a
number
of
areas,
but
electronic
record­
keeping
is.
Electronic
record­
keeping
is
ongoing.
It
is
not
prohibited.
It
is
explicitly
allowed
in
some
regulations,
and
it
is
implicitly
allowed
in
others.

And
so
EPA
does
not
have
to
do
anything
under
CROMERRR
to
fulfill
the
GPEA's
requirement
that
they
make
electronic
record­
keeping
be
available
with
one
exception.
And
that
exception
would
be
that
certain
record­
keeping
requirements
43
have,
as
stated
in
the
regulations,
words
which
imply
paper,

whether
a
written
signature
or
other
kinds
of
words
which
suggest
that
electronic
record­
keeping
would
not
be
permissible.
All
EPA
has
to
do
under
CROMERRR
is
to
say
words
such
as
that
can
be
interpreted
to
allow
electronic
recordkeeping
plus
EPA
needs
to
adopt
an
electronic
signatures
rule
that
would
allow
rules
to
be
signed
electronically.
Other
than
that,
there
is
no
need
for
a
record­
keeping
provision
in
CROMERRR
in
order
to
effectuate
the
Government
Paperwork
Elimination
Act.

On
the
other
hand,
the
stated
purpose
in
the
preamble,
or
one
of
the
stated
purposes
of
the
record­
keeping
provisions
is
to
improve
...
that's
EPA's
words
...
the
reliability,
the
security,
the
anti­
fraud
aspects
of
records
that
are
now
kept
to
improve
the
level
of
security
above
that
of
paper.
What
EPA
is
doing
is
taking
an
opportunity
presented
by
the
Government
Paperwork
Elimination
Act
to
increase,
above
the
gold
standard
of
paper,
the
level
of
security
for
records
required
by
EPA.

And
that
is,
in
fact,
treating
electronic
records
less
favorably
than
written,
than
printed
records,
contrary
to
the
purposes
of
the
GPEA.

OMB
presented
guidance
to
executive
branch
agencies
on
how
to
implement
the
GPEA.
And
in
that
guidance,
OMB
directed
EPA
and
other
agencies
to
conduct
a
risk
analysis.
A
risk
analysis
44
on
the
need
for
security
provisions,
in
other
words,
what
is
needed
to
prevent
fraud
and
what
is
not
needed
to
prevent
fraud?
And
what
is
the
cost
of
provisions
to
deter
fraud
or
to
detect
fraud?

So
if
both
a
risk
analysis
and
a
cost
benefit
analysis
are
needed
to
address
the
security
aspects,
according
to
the
OMB
guidance.
The
OMB
guidance
says
do
not
do
a
one­
size­
fits­
all
approach
because
there
are
different
risks
and
different
costs
associated
with
different
kinds
of
situations.
And
in
CROMERRR,
it
certainly
appears
to
present
only
a
one­
size­

fitsall
approach.
The
least
significant
record­
keeping
requirement
in
all
of
EPA
requires
exactly
the
same
anti­
fraud
provisions
as
the
most
abused,
most
risky
record­
keeping
provision.
One
size
fits
all
for
the
CROMERRR,
contrary
to
what
OMB
has
recommended.

The
record­
keeping
rule
docket
has
very
little
in
it
to
support
or
even
discuss
record­
keeping
under
CROMERRR
by
regulated
entities.
There
is
some
information
there
on
CDX,
on
electronic
reporting,
a
certain
amount
on
electronic
signatures,
but
there
is
virtually
nothing
there
on
electronic
record­
keeping
by
regulated
entities.
The
problems
of
electronic
record­
keeping
under
CROMERRR
are
significant.

There
are
very
challenging
technical
requirements
there.
Their
cost,
their
difficulty,
their
solutions,
their
impact,
are
not
45
discussed
in
documents
which
currently
appear
in
rule­
making
docket.
The
EPA
does
not
substantiate
the
reasons
for
this
proposal
on
record­
keeping.
Better,
a
court
on
judicial
rEviw
would
have
to
conclude
that
the
proposal
was
arbitrary
and
capricious.

EPA
has
substantially
underestimated
both
the
costs
and
the
technical
challenges
associated
with
the
record­
keeping
provisions.
It
estimates
them
at
$
40,000
plus
an
annual
cost
of
$
17,000.
EPA's
own
cost
benefit
analysis
describes
those
costs
as
prohibitive
for
any
system
which
is
set
up
solely
to
comply
with
EPA
record­
keeping
requirements.
Since
people
who
are
required
to
keep
records
for
EPA
purposes
already
have
their
computer
systems,
any
changes
to
implement
CROMERRR
requirements
would
be
solely
for
purposes
of
meeting
EPA
CROMERRR
requirements.
And
yet
this
$
40,000
figure,

prohibitive
as
it
is,
is
considerably
underestimating
the
actual
costs.
For
example,
under
the
FDA
rule,
Part
11,

pharmaceutical
companies
have
found
that
their
costs
are
in
the
millions
of
dollars
to
comply
with
part
11.
They
have
been
trying
for
four
years
to
come
into
compliance.
Many
find
that
they
have
only
made
part
of
the
journey
and
there
are
millions
of
dollars
needed
to
continue
to
be
spent.
The
costs
are
very
large
here.

Just
an
example
is
Microsoft
Excel.
Excel
is
a
very
46
widely
used
software
program
for
collecting
data
that
is
required
for
EPA
purposes.
And
yet
no
company,
no
EPAregulated
facility
in
the
country
could
use
Excel
for
that
purpose
without
buying
a
fix,
because
Excel
does
not
have
an
auditrail
(
phonetic).
There
is
a
product
that's
being
marketed
on
a
website
and
being
presented
to
FDA
which
claims
to
provide
an
auditrail
to
Excel.
The
Dow
Chemical
Company
talked
to
them;
they
want
a
lot
of
money
for
this
system.
Every
facility
in
the
country
that
uses
Excel
would
need
to
buy
that
patch
or
a
similar
one,
or
a
comprehensive
system
to
provide
the
auditrail
capability
which
is
not
currently
in
use
in
almost
all
computer
systems
today.
The
costs
of
CROMERRR's
recordkeeping
provisions
are
more
or
less
on
the
same
order
of
magnitude
as
Y2K.
Huge
numbers,
and
yet
EPA
has
not
addressed
those
numbers
in
any
of
its
analyses
to
date.

In
summary,
there
are
many
problems
with
the
recordkeeping
provisions
in
CROMERRR.
And
EPA
simply
can't
fix
them
by,
for
example,
putting
out
a
supplemental
notice
of
rulemaking
or
hiring
another
contractor
to
do
another
report.

These
are
fatal
problems.
EPA
should
sever
the
record­
keeping
provisions
of
CROMERRR
from
the
rest
of
the
proposal,
allow
the
CDX,
the
electronic
signatures,
electronic
reporting
provisions,
to
go
forward.
It
should
withdraw
the
recordkeeping
provisions
and
return
them
for
further
analysis.
Thank
47
you.

Are
there
any
responses
to
what
I'm
saying?

Joe
Retzer:
(
inaudible)

Mark
Duvall:
However
you
want.

Joe
Retzer:
It's
just
a
question
of,
you
know
there
are
nine
criteria
that
are
listed
in
the
program
records.
Are
there
some
of
those
criteria
that
are
the
...
trigger
the
costs.
I
mean,
you
mentioned
particularly
the
audit
trail.
Another
way
of
looking
at
it
would
be
to
look
at
those
individual
criteria
and
comment
on
those
(
inaudible).

Mark
Duvall:
Well
certainly
the
audit
trail
requirement
is
an
important
one
because
most
systems
today
don't
have
audit
trail
capabilities.
Another
troublesome
requirement
is
the
requirement
to
maintain
electronic
records
for
the
entire
record
retention
period.

Joe
Retzer:
Can
I
ask
you
about
that
one?
Because
the
requirement
for
maintaining
records
for
the
entire
retention
period
isn't
a
CROMERRR
requirement.
It's
a
requirement
of
the
air
program
(
inaudible).
What
are
companies
doing
anyway?
So
if
the
company
has
decided,
or
finds
it
most
efficient
to
do
electronic
record­
keeping,
that
they're
under
provision
of
a
program
rule,
like
an
air
program
rule
that
requires
(
inaudible).
How
are
you
addressing
that
as
part
of
CROMERRR?

I
don't
see
that
CROMERRR
necessarily
adds
cost.
Isn't
it
48
really
the
program
rule
that's
...?

Mark
Duvall:
No,
the
CROMERRR
is
actually
adding
the
costs.

The
reason
being
that
under
today's
rules
it
is
acceptable
to
print
out
electronic
data
and
keep
the
paper
copy
as
the
retained
copy
for
the
retention
period.
But
CROMERRR
would
require
the
electronic
copy
to
be
migrated
from
generation
to
generation
of
hardware
and
software
for
the
entire
retention
period.
The
Dow
Chemical
Company's
internal
record
retention
policies
indicate
that
after
a
certain
number
of
years,
all
electronic
documents
must
be
reduced
to
paper
precisely
because
of
this
concern
as
data
is
migrated
across
hard
software
and
hardware,
data
is
lost.
It's
very
...
and
we're
faced,
under
the
CROMERRR
record­
keeping
requirements,
with
the
dilemma
of
either
maintaining
legacy
systems
solely
for
regulatory
compliance
purposes,
perhaps
for
decades,
or
else
migrating
across
different
hardware
and
software
and
doing
the
best
we
can
with
the
inevitable
data
losses
and
corruption
that
occur.

I
might
add
that
EPA
has
to
some
degree
the
same
record
retention
problems,
to
the
extent
that
under
the
FOYA
(
phonetic)
or
other
requirements
that
EPA
itself
must
keep
data
electronically
for
the
retention
period.
EPA
is
surely
finding
itself
in
a
dilemma
of
finding
a
cost­
effective
technical
solution.
EPA
with
all
of
its
resources
from
the
government,

supported
by
the
taxpayers,
is
finding
that
requirement
49
extremely
challenging.
And
yet
every
small
business,
every
large
plant,
every
one
of
1.2
million
regulated
facilities
that
keep
records
has
exactly
the
same
problems
under
the
CROMERRR
record­
keeping
provisions.

Kathleen
Barrowclough:
...
and
first
of
all,
I
think
I'd
like
to
support
the
comments
that
Mr.
Duvall
made
on
behalf
of
Dow
for
DuPont,
as
well
as
for
the
society
of
quality
assurance.

Many
of
our
comments
are
very
similar
in
nature
to
Mr.

Duvall's.
And
just
to
illustrate
one
particular
instance
around
the
cost
of
electronic
records,
DuPont,
at
just
one
of
our
GLP
(
phonetic)
facilities,
and
this
is
just
a
GLP
tox
lab,

we
are
implementing
just
two
of
our
systems,
upgrading
electronic
data
collection
systems
in
order
to
allow
for
appropriate
electronic
archival
for
next
year.
And
this
is
really
for
Part
11
compliance,
which
would
be
similar
to
what
we'd
have
to
do
for
CROMERRR.
And
that's
going
to
cost
us
1.2
million
dollars.
This
is
just
two
systems
in
our
tox
lab
in
order
to
make
them
acceptable
as
electronic
archiving
tools.

Along
with
that,
we
have
71
other
software
applications
in
that
same
laboratory
collecting
raw
data
for
GLP
purposes
that
will
have
to
go
through
some
sort
of
similar
gap
and
risk
analysis
and
put
into
place
some
of
the
things
that
are
necessary.

As
Mr.
Duvall
mentioned,
one
of
the
options
we
have
had
in
50
the
past
was
printing
out,
so
our
analytical
instruments
that
we've
had
in
the
past,
we
have
printed
out
hard
copies
and
called
that
our
raw
data.
That
will
no
longer
be
acceptable.

And
while
we
have
maintained
our
raw
data
anyway,
we
have
kept
that
electronically
while
we
still
have
called
the
printout,
we
will
actually
be
required
now
to
migrate
that
electronic
data
and
there's
a
phenomenal
cost
associated
with
that.

And
when
I
say
that
that's
just
our
tox
lab
for
GLP
purposes,
when
I
started
working
across
DuPont,
looking
at
the
other
programs
within
DuPont
that
will
be
similarly
impacted
by
CROMERRR,
it
was
phenomenal
the
response
I
got
from
our
environmental
areas
for
the
manufacturing
companies,
the
people
who
have
to
report
water
data,
air
data,
all
of
those
different
things
...
all
of
the
things
that
monitor
and
gather
that
data
are
electronically
computer
generated
type
pieces
of
equipment.

So
that
all
of
that
information,
all
of
those
systems
will
come
under
CROMERRR,
according
to
the
way
we
read
CROMERRR
as
far
as
record­
keeping.

And
if
that's
the
case,
the
cost
is
going
to
be
phenomenal
because,
while
at
our
GLP
facility,
we
already
had
the
systems
I
talked
about
upgrading
for
archival
purposes
already
had
auditrails
on
them.
They
already
had
a
lot
of
the
things
that
we
consider
necessary
for
the
validity
of
that
particular
data.

But
now
we're
talking
about
when
you
manipulate
that
data
51
in
some
other
fashion,
if
you
manipulate
it
electronically
with
some
other
system,
that
system
will
also
come
under
the
rule.

What
we
do
now
is
we
say,
if
you're
manipulating
it
electronically
elsewhere,
for
example,
we
collect
data
in
a
data
collection
system.
We
have
to
run
it
through
a
statistical
program.
Not
all
of
our
systems
are
connected.
So
therefore,
we
may
collect
that
data
in
one
data
capture
system,

report
it
out
to
a
file
which
is
not
protected
with
auditrails
and
that
sort
of
thing,
then
put
that
report
through
our
statistical
program
which
is
again
protected
through
auditrails
and
the
appropriate
things,
but
recognizing
that
we
can
always
go
back
to
that
original
data,
that
original
report.
You
can
run
it
again,
you
can
see
that
it's
the
same
thing.
If
all
of
those
systems
are
required
to
meet
CROMERRR,
then
you're
required
to
have
those
auditrails
all
along
that
whole
pathway.

And
it
really
increases
the
cost
associated
with
maintaining
electronic
records.

George
Britton:
George
Britton
of
Aventis
Crop
Science.
A
problem
with
the
record­
keeping,
and
a
long­
term
keeping
of
these
things.
Our
(
inaudible)
company
is
involved,
has
just
come
through
a
merger.
We're
fixing
to
be
bought
again
at
the
beginning
of
the
year.
As
you
brought
these
two
companies
together,
you
had
two
different
laboratory
electronic
data
collection
systems
functioning
within.
One
group
had
one,
the
52
other
group
had
the
other.
And
the
merging
process,
you've
got
these
two
systems
side­
by­
side,
neither
one
of
those
two
systems
will
talk
to
each
other.
And
if
I
had
to
keep
that
data
for
30
or
40
decades,
I
run
into
the
problem
if
I
cannot
do
this,
even
if
I
upgrade
the
software.

One
particular
case
is
the
water's
(
inaudible)
system,

version
two
or
version
three.
Same
company,
same
data,
it
will
be
read
forward.
But
that
nine
version
three,
if
I
am
to
take
that
information
and
reprocess
it
with
the
same
parameters
it
was
collected
with
and
printed
out
the
first
time,
I
will
not
get
back
exactly
the
same
information.
It
will
be
close,
off
a
few
significant
decimal
places,
because
the
peak
algorithms
have
evolved
over
time.
Keeping
a
system
for
a
few
years,
to
be
able
to
recreate
exactly
the
same
information
is
a
viable
thing
that
you
might
do.
But
keeping
it,
at
some
point
and
time
you're
going
to
need
to
print
it
out
and
go
forward
or
some
criteria
has
to
get
to
be
in
there
...
how
close
in
the
audit
process
does
it
have
to
be
to
be
considered
exact?
Just
simply
because
the
software
algorithms
have
evolved
over
time.

Even
though
I
keep
it,
got
all
the
measure
data
there,
tell
you
who's
collected
it,
da
da
da
da
da.
But
I
still
can't
produce
precisely
the
same
result
because
the
software
has
changed.
Do
I
have
to
keep
systems
for
years
just
to
be
able
to
go
back
and
do
this?
53
Normally
in
the
EPA's
process,
there's
usually
a
reasonable
period
of
review
for
the
data,
which
is
perfectly
fine
to
keep
that,
but
say
in
a
reasonable
period
of
time
that
you
could
allow
printing
out
of
that
information,
and
let
that
be
kept
long
term,
and
not
have
to
keep
the
functionality
of
that
electronic
record
within
20,
30,
40
years,
(
inaudible)

some
of
our
problems
in
the
industry
have
been.
This
is
where
the
record­
keeping
in
the
electronic
format
is
really
burdensome.

Charles
Reese:
Good
morning.
I'm
Charles
Reese
with
BASF
Crop
Science.
First
of
all,
I
want
to
say
that
BASF
agrees
with
Mr.

Duvall
of
Dow,
the
costs
associated
with
these
systems.
We
are
in
the
process
of
implementing
a
system
that
will
keep
our
data
electronically
and
the
cost
of
that
system;
the
price
tag
is
starting
to
go
up
the
scale
and
is
approaching
4
million
dollars
for
a
metabolism
chemistry
residue
data
collection
system.
And
these
costs
don't
even
include
the
costs
of
taking
individual
instrument
component
systems
and
capturing
the
electronic
data
on
those,
and
bringing
them
in
to
the
main
system.
There
are
going
to
be
more
costs
associated
with
that.

But
my
question
here
today
has
to
do
with
Subpart
C,
3.13.

We
talked
about
this
rule
increasing
costs,
and
it
says
you
must
produce
accurate
and
complete
copies
of
any
electronic
record
or
electronic
document
and
render
these
copies
readily
54
available
in
both
human
readable
and
electronic
form
for
onsite
inspection
and
offsite
review
for
the
entirety
of
the
required
period
of
record
retention.

Our
question
is,
what
does
this
exactly
mean,
specifically
referring
to
offsite
review
for
an
electronic
record
by
the
agency?
These
are
very
intricate
systems,
they
have
multiple
components.
What
does
the
agency
expect
when
it
comes
to
reviewing
an
electronic
record
in
an
offsite
review?
Are
we
supposed
to
provide
software
and/
or
hardware
to
the
agency
offsite
to
preview
these
records?

Evi
Huffer:
The
intention
wasn't
for
the
facility
to
provide
the
agency
with
software
and/
or
equipment.
There
are,
in
our
current
regulations,
a
requirement
for
offsite
review.
You'll
have
to
go
back
and
take
a
look
at
that.
I
would
assume
the
way
it's
being
carried
out
under
the
current
regulations
is
that
you're
giving
them
a
hard
copy
and
they're
walking
away
with
it.
I
don't
know
if
that
in
fact
is
the
case
though.

Charles
Reese:
Just
to
capitalize
on
what
you
said
there.
If
you're
able
to
take
a
hard
copy
review,
a
hard
copy
printout
and
walk
away
with
a
record
like
this,
it
can
be
argued
that,

here,
with
an
electronic
record
as
stated
that,
these
electronic
records,
the
printouts,
I
mean
the
records
themselves
have
meta
data
associated
with
those.
The
meta
data
include
the,
maybe
the
methods
or
the
sequences,
or
even
the
55
algorithms
of
the
computer
that
generated
the
data
in
the
first
place.
So
now
if
you
can
accept
a
hard
copy
printout
of
review
in
that
case,
why
must
the
meta
data
and
all
this
audit
trail
and
everything
also
transfer
with
the
electronic
record
when
it's
being
stored
electronically
if
the
hard
copy
printout
is
essentially
what
you
can
take
away?
Does
that
make
sense?

Evi
Huffer:
Yes,
it
does.
Before
you
walk
away,
can
I
ask
you
a
question?
In
the
cost
that
you
sited
for
building
your
system,
4
million,
was
that
a
system
to
comply
with
the
FDA
rule?

Charles
Reese:
No
ma'am.

Evi
Huffer:
No?

Charles
Reese:
No.
We
are
strictly
an
EPA
facility,
EPA
regulated
facility
under
FIFRA
and
this
is
strictly
to
capture
data.
In
a
sense
it's
an
electronic
notebook
system
where
the
lab
technicians
won't
be
able,
won't
have
to
write
down
anything
on
paper,
they
will
be
inputting
their
stuff
electronically,
and
storing
the
record
electronically.
And
it's
going
to
have
audit
trails
and
everything
as
part
of
that.

Evi
Huffer:
So
it's
basically
the
cost
associated
with
building
the
system
irregardless
of
CROMERRR?

Charles
Reese:
That
could
be,
yes.

Evi
Huffer:
All
right;
thanks.

Walter
Retzsch:
Good
morning.
I'm
Walter
Retzsch.
I'm
56
representing
the
American
Petroleum
Institute.
API
represents
over
400
oil
natural
gas
companies
in
the
United
States
whose
operations
extend
from
expiration
and
production
through
distribution,
refining
and
marketing.
A
large
number
of
oil
and
gas
industry
facilities
maintain
a
broad
range
of
environmental
records,
many
of
which
are
used
to
comply
with
EPA
reporting
requirements
and
we
are
very
concerned
with
this
proposed
rule.

API
supports
EPA's
efforts
to
establish
voluntary
electronic
reporting
mechanisms.
API
member
companies
welcome
the
opportunity
to
submit
reports
to
EPA
electronically,
as
long
as
the
systems
developed
are
cost­
effective
and
secure.

However,
the
usefulness
of
electronic
reporting
will
be
severely
undermined
if
EPA
proceeds
with
the
record­
keeping
provisions
in
the
proposed
rule.
Although
we
have
not
completed
our
analysis
of
the
rule,
I'd
like
to
just
share
some
of
our
(
inaudible)
concerns
in
five
areas:
the
mandatory,
not
voluntary
nature
of
the
proposed
record­
keeping
requirements,

the
increased
burden,
excessive
cost
and
no
identified
benefits,
the
lack
of
necessity
for
the
rule,
the
technical
infeasibility
of
the
proposed
record­
keeping
requirements
and
some
data
security
concerns.

Although
EPA
asserts
in
the
preamble
that
the
rule
is
voluntary,
there
is
nothing
voluntary
about
the
record­
keeping
57
provisions
in
this
proposal.
EPA
is
proposing
for
the
first
time
that
existing
records
which
may
meet
EPA's
broad
definition
of
electronic
records
do
not
satisfy
EPA's
recordkeeping
requirement.

With
this
rule,
EPA's
introducing
language
that
it
would
have
very
significant
financial
and
compliance
obligations
for
oil
natural
gas
companies.
The
proposed
rule
would
establish
mandatory
procedures
and
controls
for
all
electronic
records
related
to
any
data
used
for
complying
with
the
multitude
of
EPA
reporting
requirements.
For
example,
in
just
the
air
area
alone,
the
rule
would
apply
to
NSPS
(
phonetic)
(
inaudible)

records,
permeating
reporting
requirements
on
inspections,

accidental
release
information,
calibration
data
for
(
inaudible)
control
equipment,
(
inaudible)
any
readings,
just
to
name
a
few,
and
it
goes
on.

The
proposed
rule
states,
an
electronic
record
or
electronic
document
will
satisfy
a
record­
keeping
requirement
of
an
EPA
administered
federal
environmental
program
under
this
rule
only
if
it's
generated
and
maintained
and
find
acceptable
electronic
record
retention
system
as
specified
in
the
subsection.
The
definitions
provided
for
an
electronic
record,

and
electronic
record
retention
system,
would
capture
any
data
or
information
stored
on
computers
as
well
as
the
software,

records,
documentation,
used
to
retain
exact
copies
of
58
electronic
records
and
documents.

In
essence,
EPA
would
no
longer
recognize
electronic
records
unless
computer
systems
satisfy
the
complex
criteria
set
forth
in
the
rule.
EPA
contends
that
the
rule
is
purely
voluntary,
because
companies
have
the
option
of
paper
recordkeeping
However,
many
companies
have
already
invested
heavily
in
systems
for
electronic
record­
keeping.
And
the
proposed
rule
would
require
extensive
upgrades
to
existing
systems,
or
may
even
necessitate
entirely
new
systems
to
replace
the
existing
systems.

The
only
place
where
the
proposed
rule
would
have
no
impact
would
be
where
the
records
were
maintained
in
manual
logs.
In
all
other
cases
where
the
manual
data
were
copied
into
electronic
records
such
as
Excel
spreadsheets,
mentioned
earlier,
or
custom
electronic
management
information
systems,

or
entered
directly
from
electronic
logs
to
existing
information
systems,
the
implications
of
the
rule
are
very
significant.

Based
on
the
definition
for
an
acceptable
electronic
record
retention
system,
any
system
that
is
used
for
complying
with
the
environmental
record­
keeping
requirement
would
be
forced
to
comply
with
the
record­
keeping
provisions
of
this
rule.
This
is
clearly
not
voluntary.

EPA
must
consider
the
reality
that
many
companies
have
59
already
invested
millions
of
dollars
in
computer
hardware,

software
and
support
infrastructure
for
environmental
compliance
including
record­
keeping.
Upgrading
to
meet
the
proposed
standards
would
be
very
expensive
and
switching
back
to
paper
records
is
not
a
costless
option.
It
is
also
contrary
to
the
Paperwork
Reduction
Act.
In
some
cases,
it
would
be
impossible
to
switch
back
to
paper
only
system
and
still
keep
compliant
records
because
some
information
is
by
nature
computer
generated.
For
example,
for
continuous
submissions
monitors,
fugitive
emissions
data
loggers,
laboratory
analytical
equipment,
temperature
and
flow
meters,
several
states
are
already
requiring
that
certain
reports
be
submitted
electronically.

Although
we
have
not
completed
our
calculations
for
potential
costs
for
the
oil
and
gas
industry,
an
example
of
the
excessive
costs
of
the
proposed
rule,
which
was
received
from
an
API
member
company,
is
worth
mentioning.
This
company
has
a
robust
emissions
calculations
program
that
can
calculate
all
of
their
emissions
and
then
use
the
results
for
determining
chemical
thresholds
and
emissions
annual
TRI
report.
It
took
12
to
15
man
years
of
effort
to
build
this
program
and
a
cost
of
about
two
million
dollars.
This
program
is
used
at
multiple
facilities
including
five
refineries,
pipelines
and
marketing
facilities.
Modify
this
program,
and
time,
date,
user
stamp
60
each
data
element,
and
to
allow
for
storage
and
reasonable
retrieval
of
this
auditrail
would
require
an
extensive
rewrite
of
an
extremely
complex
software
program.
The
company's
IT
contractor,
who
currently
supports
this
program
and
assisted
in
building
it
in
the
first
place
has
estimated
it
will
take
at
least
one
man
year
to
modify.
The
low­
end
costs
for
the
modifications
would
be
200
to
250
thousand
dollars.
This
cost
is
just
for
one
program
for
one
company.

In
addition
to
this
initial
cost,
the
cost
of
data
storage
and
software
maintenance
of
this
expanded
program
would
increase
significantly.
In
addition
to
fixing
the
audit
of
data
element
changes,
it
appears
that
the
rule
would
also
require
a
full
auditrail
of
any
and
all
software
modifications
along
with
a
complete
analysis
of
the
effects
of
any
results
calculated
and
any
software
changes.
If
one
is
truly
interested
in
auditing
all
data
changes,
this
is
just
the
cost.

The
company
sees
no
benefit
side
to
their
organization,
do
not
believe
that
they
have
a
data
problem
that
needs
fixing.

The
electronic
record­
keeping
provisions
would
introduce
significant
costs
to
the
oil
and
natural
gas
industry
in
the
form
of
upgrading
and/
or
replacing
existing
information
systems
that
contain
data
required
for
environmental
record­
keeping,

implementing
new
systems
for
tracking
environmental
records,

revising
an
existing
archiving
backup
and
recovery
practices
to
61
address
the
extensive
archiving
requirements
of
CROMERRR.

Our
analysis
of
the
impacts
of
the
proposal
is
in
stark
contrast
to
the
analysis
that
EPA
presents
in
the
preamble.
We
believe
that
EPA
needs
to
re­
do
its
cost
benefit
and
other
analyses
in
order
to
meet
requirements
of
executive
order
12­
8­

66,
Paperwork
Reduction
Act.

Now
I
might
mention
some
things
about
the
non­
necessity.

EPA
claims
the
proposed
rule
would
remove
obstacles
to
electronic
record­
keeping.
However,
as
practical
manner
it
would
do
just
the
opposite.
EPA
has
not
identified
the
problem
that
they
are
trying
to
solve.
EPA
already
has
the
necessary
authority
to
examine
paper,
electronic
records
to
ensure
compliance.
The
record­
keeping
requirements
are
both
unnecessarily
broad
and
unnecessarily
prescriptive.
EPA
has
not
adequately
demonstrated
the
proposed
electronic
recordkeeping
requirements
need
to
mirror
that
of
the
FDA
electronic
record­
keeping
regulations.

Consistency
with
FDA
record­
keeping
requirements
is
not
an
appropriate
goal.
The
FDA
requirements
have
proven
to
be
very
difficult
to
implement
and
very
expensive
to
the
regulated
community.
Compliance
with
the
FDA
rule
has
proven
to
be
so
difficult
that
it's
years
behind
schedule.
The
FDA
experience
should
serve
as
a
model
for
EPA,
a
model
of
what
not
to
do.

If
people
want
electronic
recording,
it
can
be
62
accomplished
in
a
manner
that
is
less
costly
and
more
efficient
than
paper
record­
keeping.
Unfortunately,
the
proposed
rule
would
have
the
opposite
effect.
Rather
than
encouraging
electronic
record­
keeping,
the
rule
would
impose
excessive
cost
that
far
outweigh
the
suggested
benefit,
thereby
discouraging
broad
implementation.
In
many
cases
the
effect
of
the
rule
would
be
a
reversal
in
the
progress
companies
have
made
in
the
area
of
electronic
record­
keeping.

Although
EPA
states
for
electronic
reporting
that
it
believes
that
technology
specific
provisions
for
reporting
would
be
very
complex
and
unwielding;
it
then
proceeds
to
propose
just
such
provisions
for
electronic
record­
keeping.

EPA
needs
to
give
further
consideration
to
current
recordkeeping
realities.

Electronic
record­
keeping
is
necessary
for
many
practical
purposes
due
to
the
complexities
of
records,
calculations
involved,
transmission
and
storage
of
records.
These
electronic
record­
keeping
systems
vary
among
companies
and
over
time.
Due
to
the
very
nature
of
information
technology,
these
variations
can
be
expected
to
continue.
Any
EPA
attempt
to
mandate
computer
system
characteristics
as
the
proposal
does
is
doomed
to
fail.
EPA's
proposal
reflects
no
awareness
of
the
current
state
of
computerized
record­
keeping
in
the
regulated
community.
The
specific
system
requirements
EPA
proposes
range
63
from
problematic
to
infeasible.
In
our
written
comments,
we'll
provide
EPA
with
additional
input
and
a
technical
aspect
of
the
record­
keeping.

The
final
area.
Some
aspects
of
data
security
and
confidential
business
information
concerns.
As
proposed,
the
rule
appears
to
allow
EPA
overly
broad
access
to
corporate
computer
systems
if
records
are
retained
electronically.
The
proposed
rule
requires
that
the
electronic
record
retention
system
be
readily
available
for
"
onsite
inspection
and
offsite
review
for
the
entirety
of
the
required
period
of
record
retention."
Most
industry
facilities
with
data
security
and
proprietary
reasons
do
not
maintain
a
system
architecture
that
would
allow
EPA
or
other
non­
employees
to
get
into
the
types
of
systems
used
for
the
clients
record­
keeping
from
offsite.

Making
these
changes
to
comply
with
the
proposed
rule
would
jeopardize
data
security,
and
would
impose
additional
cost.

EPA
already
has
authority
to
obtain
or
inspect
required
records.
There's
no
need
for
any
expansion
of
this
authority.

The
proposal
appears
to
lay
the
groundwork
for
overly
broad
EPA
access
to
entire
computer
systems.
For
the
regulated
community,
this
introduces
a
new
level
of
concern
about
keeping
business
information
confidential
and
may
limit
their
ability
to
integrate
environmental
systems
with
other
business
systems.

This
should
concern
EPA
as
well
because
inspection
or
review
64
will
not
be
facilitated.
The
companies
would
have
to
take
extra
steps
to
maintain
confidentiality
of
their
business
records.

Conclusion:
Due
to
the
various
problems
already
mentioned,
EPA
should
withdraw
the
proposed
rule.
Any
rule
involving
electronic
reporting
or
record­
keeping
must
involve
computer
experts,
software
companies
and
the
regulated
community.
API
is
in
the
process
of
assessing
the
cost
and
operational
implications
and
feasibility
of
various
provisions
of
the
proposed
rules.
We
will
be
filing
extensive
comments
in
a
few
weeks.
Thank
you.

Tom
Gilding:
Yes,
Tom
Gilding
of
American
Crop
Protection
Association.
We've
bounced
around
a
lot
this
morning
about
voluntary,
not
voluntary.
But
the
question
that
comes
to
my
mind
is
specifically
addressing
the
Office
of
Pesticide
Programs
(
inaudible)
submissions
where
the
evolving
program
is
(
inaudible)
CD
ROMS
and
I
think
you've
heard
that
they're
also
talking
paper
archiving.
And
I've
also
heard,
David,
you
say
this
morning
that
such
programs
would
be
exempt
from
reporting
from
the
CROMERRR.
The
logical
question,
which
I
haven't
heard
yet
this
morning
is
if
such
a
approach
is
exempt
from
reporting,
then
would
the
record­
keeping
requirement
also
not
apply?
Would
it
apply?

David
Schwarz:
I
think
that's
a
question
we'd
have
to
think
65
about.
I
mean
I
don't
think
that
...

Tom
Gilding:
Very
important
to
us.

David
Schwarz:
Oh
sure,
I
...

Tom
Gilding:
I
mean
I
could
go
home
right
now
if
you
say
yes...

David
Schwarz:
I'm
sure
it
is,
but
this
issue
of
reporting
and
record­
keeping
are
different.
Because
in
the
case
of
electronic
reporting
per
se,
we're
not
really
interested
in
how
you
store
the
information
that
you
report
to
us.
But
of
course
that's
really
what
the
record­
keeping
part
of
CROMERRR
is
all
about.
And
there
...

Tom
Gilding:
Well
you
are
saying
then
that
an
entity
could
be
exempt
from
reporting
but
it
still
wouldn't
be
exempt
from
record­
keeping?

David
Schwarz:
Yes,
that's
possible.
I
mean
certainly
as
currently
written.

Tom
Gilding:
When
would
we
find
this
out?

David
Schwarz:
Well,
as
currently
written,
the
proposal
has
the
characteristic
that
you've
just
articulated.
Yes,
one
could
be
subject
to
the
record­
keeping
portion
of
CROMERRR
but
not
to
the
reporting
portion
of
CROMERRR
now.
Based
on
comments
that
we
hear
here,
that
we
receive
in
writing,
we'll
obviously
want
to
think
long
and
hard
about
some
of
these
issues.
And
I
think
that
the
answer
to
your
question
about
what
we
will
do
will
66
depend
on
what
we
can
do
based
on
analysis.

Chris
Hartley:
Chris
Hartley,
DuPont.
I
have
a
comment
and
then
a
question.
The
technology
costs
and
resource
issues
associated
with
archiving
and
electronic
data
for
periods
ranging
greater
than
five
years
are
enormous.
One
must
consider
the
ever­
accelerating
rate
of
new
technology
to
the
market,
the
burden
of
maintaining
CROMERRR
compliance,
the
retirement
of
old
technology,
the
loss
of
technology
vendors
and
expertise
match
with
the
increasing
costs
for
continued
support
migration
of
legacy
systems.

My
question
is,
given
these
barriers
what
plans
does
the
agency
have
for
reevaluating
the
value
add
associated
with
existing
cost
retention
time
weighted
against
the
significant
cost
of
maintaining
records
and
the
systems
needed
to
read
and
analyze
those
records
electronically
for
periods
greater
than
five
years?

Evi
Huffer:
We're
well
aware
of
the
problems
that
are
associated
with
maintaining
records
for
long
periods
of
time.

We're
basically
pushing
the
envelope
of
technology
in
many
cases.
This
isn't
just
an
EPA
problem.
This
is
a
universal
problem.
We
are
continuing
to
do
research
on
the
electronic
records
issues.

We
are
looking
at
emerging
technologies
that
are
coming
onto
the
horizon.
How
we
deal
with
it
will
probably
be
handled
67
on
a
program­
by­
program
basis,
and
it
will
depend
on
the
probably
the
level
of
risk
associated
with
a
particular
record.

Valerie
Vonetta:
I'm
Valerie
Vonetta
with
the
Alliance
of
Automobile
Manufacturers.
I
just
wanted
to
underscore
our
concern
also
with
the
record­
keeping
provisions
and
on
the
reporting
side,
the
concern
that
there
may
be
more
than
one
person
who
would
be
involved
in
signing
off
on
the
data
that's
submitted
and
(
inaudible)
could
be
more
complicated
than
one
person.
So
the
question
that
was
raised
earlier
by
DuPont
is
also
relevant
for
us.

I
also
wanted
to
underscore
that
when
you
have
56
plants,

they
all
have
individual
facilities
that
have
had
individual
record­
keeping
and
systems
that
have
developed
over
time
from
different
bases,
so
it
is
not
always
a
simple
matter
of
one
patch
for
one
technology
for
complying
and
it's
going
to
be
a
lot
more
complex
for
each
facility
to
analyze
as
more
detail
comes
out
about
what
the
requirements
are.
Thanks.

Mike
Heyl:
My
name
is
Mike
Hile.
I'm
from
Synthetic
Organic
Chemical
Manufacturers
Association
(
SOCMA).
We
just
wanted
to
support
the
comments
of
Mr.
Duvall
from
Dow,
and
just
reiterate
the
point
that
many
of
the
record­
keeping
burdens
associated
with
the
larger
company,
the
loss
would
affect
a
smaller
company.
With
that
in
mind,
we're
concerned
that
(
inaudible)

analysis
was
not
conducted
and
that
the
rule
has
certified
that
68
there
would
not
be
a
significant
impact
on
a
substantial
number
of
small
companies.

We
would
urge
the
agency
to
review
that
and
to
rescind
the
rule,
at
least
the
record­
keeping
portion
of
it,
to
review
these
impacts.
And
due
to
the
multi­
industry
impact
that
this
is
going
to
have
on
any
industry
that
reports
environmental
information
or
may
keep
records
to
support
that
effort,
enact
the
(
inaudible)
panel
process
(
inaudible)
enforcement
in
various
acts.
Thank
you.

Howard
Kruger:
Howard
Kruger,
Proctor
and
Gamble.
Since
I've
already
made
some
of
the
points
previously
in
my
comments
on
reporting,
I
won't
go
in
much
detail
on
a
few
things.
I
will
just
reinforce
that
our
company
likewise
sees
the
recordkeeping
issue
as
the
most
significant
and
we
also
conclude
that
it
is
definitely
mandatory
and
not
voluntary
given
the
kinds
of
records
that
you
have
to
keep
and
the
current
pervasiveness
of
the
use
of
computers
and
the
business
of
business
systems
in
the
United
States
of
America.

I
do
want
to
just
comment
on
a
couple
of
things.
And
this
is
not
meant
as
a
complaint,
but
it
is
meant
that
to
give
you
some
insight
into
the
challenge
to
try
to
understand
the
economic
impact.
First
of
all,
the
scope
of
CROMERRR
is
vast.

And
one
of
the
things
we
tried
to
do
is
to
try
to
just
use
EPA's
own
figures
to
do
some
calculations.
So
going
directly
69
to
the
CROMERRR
document
itself,
and
using
figures
that
were
contained
in
the
Federal
Register,
it's
very
difficult
if
not
confusing
actually
impossible
to
recognize
and
reconcile.

First
of
all,
find
the
figures
and
then
reconcile
them.

In
some
instances,
the
agency
has
put
economic
impact
numbers
in
terms
of
facilities.
In
some
places
it's
listed
in
terms
of
respondents.
In
some
cases
it's
listed
in
terms
of
registrants.
And
these
all
occur
within
the
same
paragraph
and
within
adjacent
paragraphs.
So
it's
very
difficult
to
say
like,
okay
for
facilities,
here's
the
numbers,
or
respondents,

here's
the
numbers.

But
nevertheless,
in
an
attempt
to
do
some
calculation
on
just
the
impact
of
record­
keeping,
we
took
the
net
average
annual
savings
for
all
facilities,
for
implementing
the
reporting
...
I'm
talking
about
record­
keeping
but
you're
going
to
hear
me
use
reporting
because
I'm
trying
to
back
out
a
number.
The
net
average
annual
savings
for
all
facilities
for
implementing
the
reporting,
for
implementing
and
reporting,

electronic
reporting
was
listed
as
52.3
million.
That's
on
page
46178.
We
divided
that
by
the
net
average
annual
cost
savings
per
facility,
which
is
provided
on
page
46178,
that
being
$
1,140.
And
that
yielded
a
figure
of
45,877
facilities.

Again,
I'm
just
trying
to
find,
trying
to
calculate
how
many
facilities
were
involved.
70
Now,
although
we
believe
there
are
many
more
facilities
than
this,
just
using
that
number,
and
multiplying
it
by
the
$
40,000
upfront
cost
per
facility
which
is
provided
by
the
agency
on
page
46178,
if
you
multiply
45,877
facilities
by
$
40,000,
so
cost
per
facility
times
facility,
you
come
out
with
a
cost
by
EPA's
number
for
electronic
record­
keeping
alone,
not
counting
reporting,
of
1.8
trillion.
I
mean
seriously,
just
multiply
the
numbers.

Now
regrettably,
I'm
skipping
billions.
Sometimes
in
my
own
company
I
won't
allow
people
to
use
the
word
billion.
I
require
a
...
anytime
someone
says
a
billion,
they
have
to
say
a
thousand
million,
and
every
time
they
say
trillion
they
have
to
do
the
same
thing
because
it's
easy
to
say
1.8
trillion.

You
say
that's
not
so
much.
But
you're
using
the
`
T'
word.

You're
bypassing
billions
and
your
upgrading
from
there,
so
this
is
a
huge
cost.

And
as
I
made
the
comment
before
to
this
gentleman
up
at
the
table,
this
is
actually
real
money
that
has
to
be
found,

identified
and
then
spent,
even
though
you
may
identify
that
there
are
some
savings.
Nevertheless,
to
accrue
the
savings,

you
have
to
actually
get
the
money
in
the
first
place.
So
this
is
1.8
trillion
dollars
just
using
your
numbers.
But
it
was
very
hard
for
me
to
try
and
go
through
here
and
really
do
a
fair
economic
analysis
because
the
numbers
are
all
mixed
and
71
confused.

And
then
I'd
like
to
say
just
a
little
bit
about
the
timetable
issue
again,
realizing
that
CROMERRR
is
still
in
the
proposal
stage,
we
still
have
to
sort
of
think
about
the
eventual
issue
of
implementation.
And
I
would
just
say
that
the
agency
could
benefit
by
talking
with
their
sister
agency,

the
FDA,
regarding
the
implementation
challenge
that
they
have
faced
under
21
CFR
Part
11.

As
I
made
comment
before
to
Joe,
the
rule
was
passed
in
March
of
`
97
and
made
final
in
September
of
`
97,
so
that's
four
years.
I
personally
attended
the
audio
conferences
in
May
and
June
that
the
agency
held
this
year.
Each
was
a
half
day.
And
in
those
conferences,
they
were
saying
well
we
realize
there's
a
serious
problem
here.
We
can't
even
get
into
compliance.

But
we
will
not
hold
you
in
non­
compliance
if
you,
number
one,

generate
a
master
plan,
which
means
identifying
all
the
systems
that
your
company
has
that
needed
to
be
compliant.

Number
two,
identify
who
the
owners
are
and
what
the
deficiency
was
­­
so
a
gap
analysis.
And
then
number
three,

identify
a
time
table
that
you
believe
that
given
the
extreme
cost
that
would
be
involved
and
the
live
bodies
that
would
have
to
be
found
who
know
enough
to
actually
make
these
changes,
a
time
frame.
And
then
they
made
this
statement
that
we
realize
for
large
companies
this
could
be
very
complex
and
it
might
72
take
three,
five
or
even
seven
years.
Now
you
can
get
the
video,
you
can
get
the
reports
of
this
FDA
conference.

I
mean
seven
years.
And
we're
still
working
on
our
master
plan.
We
have
it
pretty
well
together,
but
if
you
add
seven
plus
four,
that's
eleven
years.
So
I
just
want
to
get
across
how
long
it
takes.

And
I
think
it
has
been
made
clear,
the
cost
of
some
of
these
programs
that,
we
don't
believe
they're
out
there.
Now
I'm
impressed
when
someone
found
one
of
these
that
you
can
actually
go
out
and
buy,
but
because
the
companies
have
been
working
on
them,
they
realize
how
valuable
they
are,
and
so
they're
going
to
charge
an
arm
and
a
leg.

The
final
comment
I'll
make
is
on
records
integrity
and
validity.
And
I'm
just
going
to
read
what
I
have
here.
One
item,
one
final
item
deserves
comment.
There
is
a
clear
perception
conveyed
in
the
preamble
of
an
underlying
presumption
by
EPA
that
there
is
a
problem
with
the
integrity
of
information
reported
and
records
stored
electronically.

There
seems
to
be
a
concern
from
the
EPA
about
fraudulent
records
and
records
being
changed
without
authorization.

Quite
frankly,
we're
not
aware
of
such
practices
and
we,

our
company
doesn't
have
these
problems.
But
should
EPA
discover
that
there
is
some
kind
of
a
problem
with
electronic
records,
it
has
the
authority
to
inspect
the
facility,
audit
73
those
appropriate
records,
and
determine
the
reasons
for
discrepancy.
And
then
where
appropriate
administer
penalties.

As
has
always
been
true
in
the
United
States,
there
should
be
an
exception
and
assumption
that
reported
information
and
supporting
records
are
accurate.
And
again
EPA
has
the
copy
of
the
original
record
that
they
can
measure
against.
A
key
point
here
is
accuracy
is
not
dependent
on
whether
a
record
is
held
electronically
or
paper.
If
you're
out
to
do
change,
you
can
change
an
electronic
record
as
easily
as
you
can
a
paper
record,
and
therefore
adopting
extensive
costly
measures
which
are
unique
to
individual
electronic
records
is,
to
me,
seems
ill­
advised
and
unjustified.
So
I
would
also
like
to
second
the
comments
that
were
made
by
Mr.
Duvall
and
the
gentleman
from
API.

I
don't
want
to
be
redundant
and
feel
like
I'm
dumping
a
lot
of
cold
water
on
things
that
have
already
been
said,
but
I
think
that
they
have
been,
the
agency
has
been
advised
of
problems
that
have
been
found
and
we
have
found
these
same
problems.

Thank
you.

Kathleen
Barrowclough:
Kathy
Barrowclough,
DuPont,

representing
SQA.
We
alluded
to
this
this
morning
when
talking
about
reporting.
However,
I'd
like
to
get
it
in
the
record
and
get
a
response
if
possible
around
the
record­
keeping
portion
of
74
the
rule,
whereby
in
the
preamble
and
in
the
rule
you
indicate,

or
EPA
indicates
that
you
will
provide
notice
when
you
are
now
accepting
electronic
record­
keeping.
You
say
that
same
thing
about
record­
keeping
that
you
do
about
reporting.

What
does
that
mean
for
the
almost
unanimous
group
of
the
regulated
entity
that
is
already
keeping
records
electronically?
I
think
this
is
the
point
we've
tried
to
get
across,
that
we're
already
keeping
records
electronically
for
all
of
the
different
environmental
programs,
not
just
the
GLP
program.
And
what,
what
do
we
have
to
do
when
CROMERRR
is
issued
if
we're
already
keeping
records
electronically?
Do
we
have
to
wait
for
you
to
issue
something
in
the
Federal
Register
saying,
now
for
X­
Y­
Z
program
we
are
accepting
records
electronically,
or
how
is
that
applying
across
all
the
programs?

Michael
LeDesma:
The
rule
does
not,
and
purposefully,
does
not
speak
to
record­
keeping
that
is
currently
ongoing.
So
whatever
the
status
of
that
record­
keeping
is,
the
proposal
and
the
final
rule
wouldn't
change
it.
Now
what
the
turn­
on
provisions
that
are
described
in
the
rule
are
intended
...
I
mean,
to
back
step,
what
we're
doing
here
is
we're,
we
are
with
this
rule
creating
omnibus
requirements
that
we
then
intend
to
turn
on
with
respect
to
certain
programs
(
inaudible).

For
example,
with
respect
to
CDX,
we've
got
to
prepare
web
75
pages
and
things
that
need
to
go
up.
They'll
need
to
be
available
for
people
to
submit
this
information
with
the
agency.
And
so
the
way
the
rule
is
structured,
is
that
this
rule
will
be
finalized,
will
take
effect,
and
then
we
will
let
people
know
that
we've
now
finished
the
work
involved
in
turning
on
a
system
that
is
...
they
can
go
to
our
website
or
using
the
CDX
process,
go
to
our
website
and
find
the
information
there.

The
same
has
to
do,
I
mean,
so
the
reporting
provisions
have
the
turn­
on
feature.
The
electronic
record­
keeping
provisions,
in
my
understanding,
apply
as
soon
as
CROMERRR
becomes
effective.
So
there's
a
split
there,
as
I
understand
it.

David
Schwarz:
Well,
I
think
one
of
the
issues
that's
been
raised
by
the
commentators
is
that
the
proposal
makes
assumptions
about
the
prevalence
of
current
electronic
recordkeeping
which
may
in
fact
be
a
mistake.
It's
something
we've
obviously
got
to
consider.
And
part
of
the
basis
for
that
assumption
was
our
understanding
that
many,
although
certainly
not
all,
that
many
EPA
record­
keeping
provisions
or
environmental
regulations
have
references
to
paper
that
we
had
interpreted
as
precluding
that
kind
of
record­
keeping.

On
that
assumption,
the
idea
was
that
as
CROMERRR
was
implemented,
we
would
program
by
program,
but
rather
the
76
programs
themselves,
when
they
felt
that
they
were
ready
to
conduct
their
compliance
monitoring
in
an
environment
that
involves
electronic
records,
publishing
those
and
saying
we're
ready.
What
we've
been
hearing
this
morning
is
that
some
of
those
assumptions
may
be
mistaken.
And
correspondingly,
I
think
we
need
to
obviously
consider
that,
whether
that's
true
or
that
may
affect
the
structure
of
this
part
of
CROMERRR.

Michael
LeDesma:
(
inaudible)
program
may
not
work
(
inaudible)

electronic
record­
keeping
in
some
cases,
there
may
be
some
cases
where
CROMERRR
says
no
I
want
a
piece
of
paper
with
a
signature
on
it
as
the
record
on
the
side.
And
so
we
didn't
want
to
sort
of
globally
say
at
this
point
that
you
have
to
keep
a
record
for
EPA
automatically.
It
could
be
electronic
because
there
were
some
programs
who
said,
no
wait
a
minute,

there
were
some
pieces
of
paper,
some
cases
where
we
still
want
to
have
a
piece
of
paper.
So
we
wanted
to
give
them
the
ability
to
continue
to
require
paper
in
this
(
inaudible).

Bill
Barta:
Bill
Barta,
FMC
Corporation.
I
have
a
couple
of
comments.
There's,
in
quite
a
few
places
in
the
regulation
it
talks
about
exact
copies.
And
I
wasn't
quite
sure
what
that
meant.
I
think
I
do,
but
I'd
like
to
hear
your
version
of
that.
And
also
I'd
like
to
hear
what
you
think
the
impact
that
would
be
on
both
the
regulatory
and
the
legal
side.
For
example,
40
CFR
169.2,
Part
K,
is
books
and
records,
which
77
requires
the
pesticide
industry
to
maintain
the
originals
of
all
documents.
And
I'd
like
to
hear
how
you
think
that's
going
to
be
impacted
by
the
rule.

And
if
in
fact
we
do
have
to
keep
those
originals;
that
means
legacy
systems,
which
are
a
problem.
I
just
want
to
give
a
brief
anecdote
that
I
had
last
month
where
someone
wanted
to
archive
a
386
computer.
And
the
reason
he
wanted
to
do
that
was
he
had
a
piece
of
software
that,
number
one,
he
needed
to
have
to
have
a
PC
that
had
a
three
and
a
half
and
a
five
and
a
quarter
inch
drive,
but
he
also
wanted
to
have
a
CPU
of
a
certain
speed
because
the
software
was
designed
to
run
on
certain
speed
and
the
new
computers
would
not
run
his
software.

So
I
asked
our
IT
department
how
feasible
this
was,
and
they
said
well
you
can
do
that.

But
you
have
to
understand
computers
are
instruments
that
have
to
be
turned
on
periodically.
If
you
put
it
in
a
closet
for
a
year,
and
turn
it
on,
it
probably
won't
work.
So
I'd
like
to
hear
your
comments
about
the
exact
records.

David
Schwarz:
Can
you
help
us
out
maybe
and
give
us
a
site
or
two
where
the
exact
copy
phrase
occurs
just
...

Bill
Bartaff:
There's
one
mentioned
in
the
definitions
sections
under
electronic
record,
I
believe.
Yes.

David
Schwarz:
Well,
I'm
not
sure
where
the
question
is
going.

The
thing
is,
I'd
ask
again
if
maybe
you
can
help
us
a
little
78
bit
more
here.
And
maybe
say
a
bit
more
about
the
kind
of
issue
that's
riding
and
how
this
term
exact
copies
is
used
in
the
definition.

Bill
Bartaff:
The
issue
is
I
want
to
know
if
I
have
to
keep
and
exact
electronic
version
with
all
the
meta
data
forever
because
if
I
migrate
it,
IT
people
tell
me
that
the
migrated
version
is
not
an
original.
It's
a
duplicate;
it's
a
copy.
And
are
the
books
and
records
people
going
to
accept
what
the
IT
people
call
the
duplicate
as
an
original.
It's
a
little
legalistic,

it's
technical
...

David
Schwarz:
Right,
no
...

Bill
Barta:
But
I
want
to
know
if
...

David
Schwarz:
Well
it's
helpful,
and
I
don't
think
I
want
to
sit
here
and
try
to
answer
that
question
off
the
top
of
our
head.
I
think
it's
a
good
issue
to
raise
and
I
think
we
need
to
think
a
little
harder
about
that.
I
hope
that
the
answer
to
your
question
is
no,
not
in
that
sense.
But
before
I
say
that
I'm
going
to
consult
with
some
of
my
colleagues
...

Bill
Barta:
Sure.

David
Schwarz:...
and
make
sure
that
actually
works
for
them.

Bill
Barta:
It's
a
special
case
for
the
ag
business.

David
Schwarz:
Okay.
Thank
you.

Pat
Wood:
I'm
Pat
Wood
with
Georgia
Pacific
again
and
I
found
this
most
interesting
listening
this
morning
and
I
appreciate
79
all
the
work
that
all
of
you
have
done
and
it
strikes
me
that
when
I
step
back,
a
couple
things
strike
me
as
a
problem
that
we
have.
The
rule
itself,
or
the
proposal,
is
not
very
big,

but
it
is
incredibly
complex.
And
in
fact
I
think
that
Howard
Kruger
said
that
there's
something
like
47
questions
that
you
raise
in
the
document
that
we're
all
sitting
here
not
quite
figuring
out
(
inaudible)
computers
turned
on
forever
more
or
the
original
copies
or
what
do
we
do.

But
nonetheless
if
I
could
just
think
about
timing,
and
this
has
nothing
to
do,
it's
not
your
fault.
I
feel
very
sympathetic
to
the
agency
right
now.
You
have
a
proposed
rule
that
hit
the
Federal
Register
on
August
31st,
which
is
right
before
Labor
Day
when
most
of
us
were
on
vacation.
Two
weeks
after
that
the
world
changed
for
all
the
us.
Most
people,
when
I
try
to
talk
about
this
to
other
businesses
around
town,

people
haven't
read
it.
They
aren't
aware
of
it;
they
don't
know
what
CROMERRR
means.
They
think
maybe,
we
don't
make
chrome;
we
don't
have
(
inaudible)
problems.
This
is
funny
but
it's
also
very
tragic,
because
what
you
really
have,
it
seems
to
me
that
you've
addressed
three
different
things
here.

First
of
all,
the
Central
Data
Exchange,
which
some
of
us,

as
Joe
talked
about
some
time
ago,
we're
supportive
of
it.

Those
of
us
who
have
tried
to
do
something
about
data
quality
issues
in
the
agency
see
the
idea
of
electronic
reporting
as
80
the
right
step
forward.
But
something's
happened
to
it
in
making
that
step
forward.
First
of
all,
the
Central
Data
Exchange
is
not
understood
even
by
the
people
here
in
these
rooms.
And
this
is
the
dedicated
group
of
people
who
actually
tried
to
read
this
proposal.
The
rest
of
the
world
doesn't
know
it
exists.

Second,
you
then
are
talking
about
this
is
a
voluntary
proposal,
but
yet
this
morning
I've
heard
you
all
say
that
yes
indeed,
you
might
not
actually
be
electronically
reporting
but
you
would
become
subject
to
the
record­
keeping.
And
that
is
the
essence
of
what
worries
all
of
us
about
it,
that
we're
caught
up
in
this,
and
the
entire
universe
of
the
regulated
population
in
this
country
is
caught
up
in
it,
but
I
would
say
that
not
even
one
percent
is
aware
of
it.

And
my
suggestion
is,
what
really
needs
to
be
done,
is
you
need
to
(
inaudible)
the
entire
world
and
break
it
up
into
three
parts
and
have
a
series
of
public
meetings
with
both
the
regulated
public
and
the
states
so
that
we
can
all
understand
what
it
is
we're
talking
about
before
(
inaudible).
And
I
find
particularly
interesting
the
turn­
on
feature,
because
if
I
understand
it,
with
my
limit
of
understanding
of
the
way
this
whole
thing
works,
right
now
certain
elements
might
not
be
subject
to
this.
Even
by
your
interpretation,
but
six
months,

a
year,
two
years
from
now,
there
might
suddenly
be
a
decision
81
from
one
of
the
programs,
and
then
because
this
would
be
a
final
rule,
and
people
had
not
objected
to
it,
just
as
we've
seen
with
the
pharmaceutical
industry,
we
would
find
great
gobs
of
the
regulated
community
to
be
brought
into
this,
having
giving
up
their
opportunity
to
comment
because
that
would
have
occurred
in
the
year
2001,
correct?

I
mean,
that's
my
reading
of
what
we've
heard
today.
So
I
would
urge
that
you
take
it
back,
split
it
up
into
three
parts,

and
we
go
back
and
try
hard
to
translate
it
in
such
a
way
that
we
can
actually
get
everybody
else
educated
(
inaudible).

Kathleen
Barrowclough:
Kathy
Barrowclough,
DuPont.
And
I'd
like
to
follow
up
with
Bill
Barta's
question
around
exact
copies.
The
definition
for
electronic
record,
as
stated
in
the
rule,
is
any
combination
of
text,
graphics,
data,
audio,

pictorial
or
other
information
represented
in
digital
form
that
is
created,
modified,
maintained,
archived,
retrieved
or
distributed
by
a
computer
system.
So
I
think
we
can
see
what
we
believe
an
electronic
record
is
that's
covered.

But
then
the
other
thing
is,
it
defines
an
electronic
record
retention
system
means
any
set
of
apparatus,
procedures,

software,
records
or
documentation
used
to
retain
exact
electronic
copies
of
electronic
records
and
electronic
documents.
We
have,
and
then
your
requirements
for
electronic
records
apply
to
electronic
records
in
an
electronic
record
82
retention
system.
So
if
we
only
have
electronic
record
retention
systems
that
have
exact
copies
but
not
the
original
raw
data,
okay...
So
if
you
think
of
the
original
data
as
not
an
exact
copy,
then
really,
do
your
electronic
records
that
are
in
your
data
collection
systems
for
original
data
not
covered
by
CROMERRR?
Is
it
only
if
you
migrate
it
somewhere
so
that
you've
got
an
exact
copy
of
it
somewhere
else
in
some
other
electronic
data
retention
system?

We're
not
thinking
that
what
was
intended.
We're
thinking
that
you
meant
if
you've
got
an
electronic
record
retention
system
with
your
original
raw
data
in
it,
you
have
to
meet
the
electronic
record
requirements.
But
where
we're
talking
about
the
scope
of
the
rule,
some
of
the
people
who
I
had
talked
to
said
well,
maybe
the
scope
isn't
as
broad
as
what
you
think.

Maybe
it's
only
if
you
migrate
it
somewhere
based
don
this
exact
copy
piece
of
the
retention
system.

Can
you
give
us
what
your
intention
was
there?
Is
it
really,
if
you've
got
an
electronic
record,
with
original
data
in
it,
you're
requiring,
or
you're
suggesting
that
CROMERRR
applies
with
those
nine
requirements.

David
Schwarz:
I
think
the
intention
is,
yes
to
that.
And
it
may
be
that
the
definition
needs
to
be
recrafted
in
some
way.

Michael
Penders:
Hi,
I'm
Michael
Penders.
I'm
the
president
of
Environmental
Protection
International
and
I'm
83
working
with
the
ACC
(
phonetic)
on
some
issues
regarding
this
rule.
Let
me
say
first
the
respect
I
have
for
those
on
the
table
for
putting
together
this
rule.
And
when
I
site
section
3­
2000,
the
criteria
for
acceptable
electronic
document
receiving
systems,
I
think
that's
a
laudable
effort
in
identifying
the
elements
of
what
we
may
build
into
environmental
security
systems.
And
there's
a
lot
of
work
going
on
in
that
area.

I
submit,
however,
they
really
do
not
have
a
place
in
this
rule,
particularly
from
an
enforcement
and
compliance
perspective.
I
participated
when
I
worked
at
EPA's
Office
of
Enforcement
and
Compliance
Assurance
in
the
1999
ELI
(
phonetic)

form
that's
cited
in
this
Federal
Register
notice.
And
at
that
time,
I
advocated
moving
forward
with
electronic
reporting
without
respect
to
the
record­
keeping
requirements
that
were
just
then
being
discussed
in
an
initial
stage.
I
thought
that
because
they
were
admissible
in
court
already,
if
there
were
evidence
of
fraud
dating
back
to
the
time
of
the
telegraph,

that
the
agency
should
go
forward
with
the
existing
electronic
reporting
regime
that
was
in
place
at
that
time.

I
still
think
after
reviewing
the
proposed
rule
that
the
agency
has
much
more
to
gain
from
an
enforcement
and
compliance
perspective
in
moving
forward
and
keeping
the
barriers
low
to
electronic
reporting
from
the
regulatory
community
to
the
84
agency.
There's
a
whole
world
of
useful
information
that
the
agency
can
then
use
from
enforcement
and
targeting
perspective
and
indeed
from
an
environmental
security
perspective,

nationally
and
internationally,
that
now
is
very
difficult
to
get
at
and
work
together
because
it's
not
in
electronic
form.

However,
what
I've
heard
here
is
that
the
costs
and
obstacles
for
moving
forward
with
these
elements
at
this
time
would
present
a
substantial
obstacle
for
companies
in
moving
forward
with
electronic
reporting.
I
don't
think
that
is
the
intent
of
this
rule
and
these
elements.
The
intent
of
some
of
these
elements
as
I
read
them
were
to
ensure
the
integrity
of
the
submission
and
the
audit
trail
and
other
elements.
I
think
there
are
other
forms
and
that's
evolving.
We're
actually
working
with
some
data
companies
to
develop
certain
of
these
measures
in
the
context
of
data
systems,
audit
trails
and
electronic
reporting.
However,
I
think
in
the
context
of
this
rule
that
raises
the
level
and
imposed
costs,
and
I
don't
think
there
is
any
corresponding
enforcement
and
compliance
benefit
to
setting
these
forth
in
this
rule
at
this
time.

Instead,
as
with
all
electronic
records,
they
are
admissible
in
court.
And
then,
if
there
is
a
question
as
to
the
fraud
or
other
aspects
of
it,
you
then
go
behind
the
submission
and
indeed
even
two
years
ago,
I
thought
in
a
context
of
electronic
reporting
there
is
more
in
the
issue
of
85
reliability
and
what
is
submitted
than
some
paper
records
currently
being
kept.

I
don't
think
that
this
is
a
good
vehicle
to
go
beyond
what
is
currently
kept
in
terms
of
records,
audit
trail
and
reporting
for
paper
records.
This
is
not
the
vehicle
to
bootstrap
these
other
elements,
which
may
be
critical
to
a
facility,
from
an
environmental
security
perspective,
but
I
don't
think
are
essential
in
going
forward
with
the
rule
to
encourage
electronic
reporting
and
particularly
from
an
enforcement
and
compliance
perspective
at
this
time.
I'll
submit
formal
comments
analyzing
this
in
more
detail.

Howard
Kruger:
This
will
be
very
brief;
I'll
make
a
few
comments
after
lunch,
but
there
was
a
suggestion,
because
so
many
of
the
things
that
have
been
said
here
have
been
`
can't
do
this,'
`
we
need
to
do
this,'
a
lot
of
changes,
there
was
a
suggestion
made
by
the
gentleman
from
API
and
I
think
Ms.
Wood
made
the
same
thing.
And
I
think
it's
very
productive
and
I
don't
want
it
to
get
lost.
And
that
is,
I
think
there's
a
benefit
here
in
getting
together
a
group
of
representatives
from
the
regulated
community,
the
agency,
computer
experts
and
software
developers.
Get
those
people
together
and
then
understand
what
the
specific
goals
are
very
clearly,
and
then
work
out
a
feasible
solution.
I
just
didn't
want
that,
because
it
was
said
right
at
the
end
of
this
gentleman's
testimony,
and
86
I
thought
it
was
a
very
powerful
point.

(
LUNCH)

Evi
Huffer:
Just
a
note.
Your
names
will
be
part
of
the
official
transcript
at
today's
meeting
that
will
go
into
the
docket,
so
you'll
find
the
information
there
as
well.

Jim
Steffel:
Yes,
Jim
Steffel,
representing
the
NAICC,

National
Alliance
of
Independent
Crop
Consultants.
And
I
just
wanted
to
follow
up
on
a
few
of
the
points
this
morning.

Relative
to
cost
and
listening
to
these
large
organizations
that
report
their
sales
in
magnitudes
of
billions
or
hundreds
of
millions,
we
represent
a
group
of
contract
researchers
who
actually
generate
the
data
that,
the
actual
data
that
supports
the
field
data
that
supports
the
missions.

And
we
have
some
very,
very
small
members,
some
of
our
members
that
likely
do
an
annual
couple
studies
is
$
10,000
a
year.
And
a
rough
estimate,
and
we
will
try
to
fine­
tune
this
a
bit,
but
probably
80
to
90
percent
of
our
members
fall
in
the
category
of
gross
sales
of
$
50,000
to
$
500,000
per
year,
which
would
certainly
emphasize
the
impact
of
these
additional
costs.

And
definitely
eliminate
some
of
our,
the
feasibility
of
doing
this
work
for
some
people.

One
issue
does
come
to
play
in
our
case,
unlike
many
of
the
other
people
who
are
mandated
by
the
location
of
their
facilities,
the
ag
industry
is
mandated
to
show
geographic
87
diversity
in
their
studies.
So
on
the
other
side
of
the
scale,

it
is
important
to
have
the
small
operators
in
certain
remote
locations
that
represent
geographic
areas
of
all
types
of
production
areas
(
inaudible).
So
this
is
a
real,
causes
a
problem
in
our
group,
that
we're
trying
to
deal
with.

We
generate
raw
data,
which
is
transferred
to
the
sponsors,
but
we
also
provide
our
own
raw
data
in
a
sense,
our
support
data,
the
environmental
data
and
our
facility
data.
So
we
would
also
come
under
the
requirement
to
archive
our
own
data,
and
there
is
some
concern
about
the
ramifications
of
CROMERRR
in
us
transferring
the
raw
data
we
collect
for
the
sponsors,
transferring
that
raw
data,
moving
the
raw
data
from
our
facilities
to
their
systems.
So
these
are
just
some
of
the
issues
that
we
will,
I
think
in
support
of
some
of
the
things
that
have
been
said
here
this
morning,
we
will
try
to
comment
further
on.

Charles
Reese:
Hi,
Charles
Reese
of
BASF
Corporation.
I
just
wanted
to
make
a
clarification
on
my
beginning
statement
about
our
system
that
we
were
developing.
I
say
we
may
have
spent
four
million
dollars
developing
a
system
which
we
did
develop
under
FIFRA,
but
based
on
our
June
6,
2000
meeting
that
we
had
in
Chicago
with
the
agency,
and
we
first
learned
of
CROMERRR,

we
did
have
to
change
the
scope
of
the
development
of
that
system
which
significantly
increased
the
cost.
Because
we
had
88
to
add
the
audit
trail
functionality,
the
validation
and
so
forth,
to
meet
CROMERRR.
And
since
CROMERRR
wasn't
out,
we
did
this
based
on
Part
11,
which
we
understood
that
the
agency
was
using
as
an
example.
Just
that
clarification.

Charles
Reese:
What
I
want
to
talk
about
now
though
is
a
couple
of
things.
What
was
mentioned
before
about
this
one
size
fits
all
mentality
to
the
electronic
record
that
concerns
us
greatly
is
that
if
Title
III
is
going
to
require
everything
under
Title
40
to
fit
CROMERRR,
you
have
different
types
of
records
that
you
have
to
be
concerned
with.

Certainly
some
records
are
very
important,
but
others
are
lesser
importance.
An
examples
would
be
something
such
as
a
master
schedule,
which
is
required
under
Title
40,
CFR
Part
160,
but
is
simply
a
list
of
the
studies
that
the
testing
facility
is
running.
Now
where
does
it
become
important
for
this
type
of
record
to
have
an
audit
trail
functionality,
to
have
validation,
to
have
forward
mobility?
And
there
really
isn't
any
metadata,
but
I
can
tell
you
right
now
all
the
FIFRA,

most
all
the
FIFRA
companies
are
using
Excel.
This
is
just
a
simple
list.

But
however,
this
is
just
one
example,
and
there
are
many
examples,
you
have
SOPs,
you
have
training
records,
you
have
the
master
schedule.
So
these
are
things
that
you
may
have
electronically,
you
may
choose
to
do
electronically,
but
these
89
things
aren't,
they're
required
by
Title
40
but
they're
not
what
we
would
consider
a
high
level
of
priority
for
security.

And
so,
but
if
CROMERRR
applies,
then
it
applies
right
now
across
the
board
in
every
level.
So
that's
a
concern.

One
thing
we
had
talked
about,
what
Jim
just
said,
a
small
business,
small
businesses,
BASF
is
in
the
business
of
using
contractors
to
do
work
for
us.
But
these
contractors
could
be
using
systems
that
are
completely
different
than
BASF
systems.

So
if
you
have
a
contractor
using
a
Platform
A,
and
we've
hired
them
but
we
use
Platform
B,
how
is
it
that
we're
supposed
to
transfer
these
records,
or
will
the
system
be
that
we
pay
to
maintain
the
records
at
the
contract
facility?
These
raise
all
kinds
of
questions
and
costs
as
to
how
to
achieve
those
goals
so
we're
in
compliance.

One
thing
I
wanted
to
get
back
to
is
the
bottom
line
is,

that
companies
are
interested
in,
is
compliance.
How
do
we
comply?
We
know
there's
going
to
be
a
rule;
we
know
that
we're
going
to
have
to
comply
with
it.
So
what
does
that
take?
The
reason
I
ask
that
is
because
there
are
some
things
in
CROMERRR
that
we're
interested
in,
but
that
CROMERRR
doesn't
really
say
anything
about.
One
of
those
things
is
validation.
We
know
we
have
to
have
it,
and
we
agree
we
have
to
have
it,
but
what
is
acceptable
validation?

It
shouldn't
come
down
to,
well
you
get
your
first
audit
90
and
you're
not
doing
it
right.
So
you
need
some
sort
of
guidance
there.
June
6,
2000,
I
believe,
Evie,
you
actually
mentioned
GLPs
quite
a
bit,
which
have
an
example
of
validation.
And
now
we've
moved
toward
Part
11
as
an
example,

so
if
we're
going
to
go
back
and
rework
this
electronic
recordkeeping
then
we
have
to
take
into
account
how
to
manage
validation.

My
last
comment
is,
since
GLPs,
we
also
have
a
counterpart
in
the
European
side,
the
OECD.
The
OECD
states
that
at
the
end
of
a,
the
end
of
the
life
of
an
electronic
system,
you
have
the
ability
to
migrate
to
a
different
medium.
Now
they
don't
say
what
that
medium
is,
but
to
a
different
medium.
That
would
imply
that
if,
once
an
electronic
system
has
run
its
course,

that
a
paper
medium
is
acceptable
if
you
can
no
longer
move
from
one
electronic
platform
to
the
next.

So
is
it
possible
when
we
re­
look
at
this
and
rethink
about
it,
that
we
could
actually
look
at
something,
at
least
have
an
out,
if
your
system
is
completely
incompatible
with
the
next
technology
...
You
know,
I
always
bring
this
up,
but
we
have
Pentiums
now,
but
just
around
the
corner
is
Iteniums.
So,

and
a
few
other
people
had
mentioned
that
platforms,
running
old
software
on
new
platforms
just
didn't
work.
So
there
is
the
opportunity
here
to
have
a
legal
out,
where
you
can
print
out
these
things,
like
the
OECDs
give
us,
so
we
can
manage
this
91
a
little
better.

Evi
Huffer:
What
document
or
guidance
are
those
OECD
provisions
under?

Charles
Reese:
Yes,
it's
a
consensus
document.
Yeah.
I
can
(
inaudible)...

Evi
Huffer:
(
inaudible)

Charles
Reese:
Yes,
I
can
get
that
to
you,
Evie.

Evi
Huffer:
If
you
could,
that
would
be
great.

Charles
Reese:
Okay.

Evi
Huffer:
Thank
you.

Charles
Reese:
Thank
you.

David
Schwarz:
If
you
or
any
of
the
other
commenters
have
a
principled
way
to
distinguish
between
records
that
need
a
high
degree
of
security
and
those
that
maybe
don't,
we
would
be
very
interested
in
those
proposals.

Jamie
Conrad:
Thanks.
I'm
Jamie
Conrad;
I'm
with
the
American
Chemistry
Council.
I
don't
have
a
statement
but
I
did
have
some
questions
I
thought
I
would
just
ask,
and
maybe
some
suggestions
that
could
come
along
with
them.
In
developing
this
rule,
have
you
all
sort
of
taken
kind
of
an
inventory
of
EPA's
own
record­
keeping
requirements
in
terms
of
which
ones
either
mandate
or
allow,
explicitly
allow
electronic
recordkeeping
versus
those
that
are
silent
on
the
topic,
versus
those
that
say
they
must
be
paper?
92
David
Schwarz:
We
did
a
sort
of
partial
inventory.
We
did
a
search
of
our
requirements
to
see
where
certain
keywords
came
up
that
seemed
to
suggest
paper.
And
we
got
tens
of
thousands
of
hits,
and
that
was
enough
to
explain
to
us
that,
given
our
timetable,
going
through
the
CFR
and
trying
to
tease
out
each
of
these
was
simply
beyond
the
scope
of
our
resources.
But
it
also
persuaded
us
that,
at
least
in
terms
of
addressing
the
removal
of
those
kinds
of
obstacles
to
record­
keeping
,
we
really
needed
a
sweeping
approach,
rather
than
amending
the
CFR
provision
by
provision.
So
we
did
some
things
in
that
direction,
but
not
a
complete
analysis.

Jamie
Conrad:
Because
I've
seen
someone
who
did
a
keyword
search
of
computer,
through
40
CFR,
just
the
air
ones
and
the
list
goes
on
like
this.
We
can
I
think
forward
that
to
you,

but
there's
quite
a
lot
of
them.
I
also
said,
I
think
in
a
meeting
once,
that
we
had
compiled
all
these
record­
keeping
requirements.
Had
we
given
you
this
at
the
last
meeting?

David
Schwarz:
No.

Jamie
Conrad:
Here
it
is.
It
leaves
out
FIFRA,
unfortunately,

but
it's,
the
pagination's
messed
up.
It's
208
pages
(
inaudible)

Female
Participant:
(
inaudible)

Jamie
Conrad:
Well
there
won't
be
an
audit
trail.

David
Schwarz:
It's
all
right.
It's
only
a
proposed
rule.
93
Jamie
Conrad:
How
about
...
I
guess
a
related
question
is,

have
you
done
any
looking
into
how
regulated
entities
that
keep
records,
whether
they
use
paper
or
computers
or
at
what
point
in
the
process
they
use
computers?

Evi
Huffer:
We're
doing
that
research
right
now.
Again,
based
on
our
early
analysis,
it
did
not
look
like
electronic
recordkeeping
was
that
widespread
across
the
industry.
When
you
talk
about
the
programs
where
electronic
record­
keeping
is
allowed,

we
basically
know
the
good
laboratory
programs,
the
acid
rain
program,
reformulated
gas.
And
then
there
are
the
other
programs
that
do
mag
media
electronic
reporting.

Jamie
Conrad:
Well,
I
suppose
that
(
inaudible)
comments
will
be
illustrating
many
of
the
instances
where
electronics
...

Evi
Huffer:
And
again,
where
you
can
give
us
specific
examples
where
you're
using
electronic
record­
keeping,
for
what
particular
programs,
that
would
be
very
useful.

David
Schwarz:
I
just
feel
I
need
to
add
to
that.
As
you
know,
we
did
hold
two
public
meetings
on
the
rule
substantially
before
the
proposal.
I
think
they
were
in
the
spring
and
early
summer
of
2000.
And
we
had
hoped
that
companies
that
in
fact
were
doing
electronic
record­
keeping
would
make
themselves
known
and
that
we'd
service
those
kinds
of
concerns
early.
But
we
really
did
not
get
very
many
comments
that
suggested
to
us
that
this
was
an
ongoing
activity.
94
Jamie
Conrad:
I
actually
went
to
that
meeting,
the
one
July
11,
2000,
and
I
have
the
original
paper
copy
of
the
handouts
that
were
in
my
notes.
And
this
is
my
note
up
at
the
top
with
an
asterisk:
people
are
freaked
about
not
being
able
to
print
out
computer
documents
and
sign
them.

Few
people
have
or
can
afford
all
the
electronic
audit
trail
stuff
to
ensure
no
changes.
So
I
heard,
I
mean,
people
saying
FIFRA
reporting
may
not
be
operative
but
the
FIFRA
record­
keeping
rules
might
apply
if
you
keep
records
electronically.
So
there
were
plenty
of
people
who
referenced
the
FDA
rule
and
FIFRA
at
that
meeting.

Evi
Huffer:
Again,
most
of
those
folks
were
companies
that
were
subject
to
the
automatic
Good
Laboratory
Practices
under
the
FDA
program.
It's
basically
a
group
of
industry
that
commented
largely
at
those
meetings
and
they
were
largely
the
FIFRA
labs
(
inaudible)
...

Jamie
Conrad:
Yes,
but
I
guess
it
seems
though
(
inaudible).

Where
folks
are
keeping
records
electronically,
do
you
believe
that
the
Government
Paperwork
Elimination
Act
requires
anything,
EPA
to
do
anything?
Say
for
example,
under
NESHAP
where
people
are
keeping
electronic
data
on
air
missions.

Michael
LeDesma:
The
question
is
does
the
Government
Paperwork
Elimination
Act
compel
EPA
to
(
inaudible)
...

Jamie
Conrad:
Compel
EPA
to
do
anything
about
those
instances
95
where
electronic
record­
keeping
is
going
on
and
no
one
seems
to
be
unhappy
with
it,
or
preventing
it,
or
no
one's
denying
these
records'
legal
validity
or
that
sort
of
thing.

Michael
LeDesma:
If
I
recall
correctly,
EPA
required
that
we
make
an
option
of
electronic
reporting
and
record­
keeping
available
where
practical.
(
inaudible)
to
make
that
available
across
the
board
(
inaudible)

Jamie
Conrad:
So
how
would
that
relate
to
what's
going
on
now?

Evi
Huffer:
I
think
that,
is
your
point
the
fact
that
you're
claiming
that
widespread
electronic
record­
keeping
is
already
going
on
in
various
programs
across
the
board.

Jamie
Conrad:
I'm
thinking
if
GPEA
says
that
agencies
should
make
electronic
reporting
available
where
that's
a
practical
option,
and
that
they
should
ensure
that
electronic
records
aren't
denied
legal
validity
and
enforceability
and
so
on.
If
in
fact
that's
what
seems
to
be
occurring,
then
one
interpretation
of
the
GPEA
no
obligations
on
EPA
to
do
anything
further.
It's
only
in
those
instances
where
the
word
paper
is
used
in
the
regulation
that
creates
an
obstacle.
The
GPEA
would
say
you've
got
to
take
that,
you
know,
paper
word
out
of
the
regulations,
but
that
otherwise,
if
it
ain't
broke
don't
fix
it.

Michael
LeDesma:
Well,
I
mean,
unless
industry
stands
up
as
a
whole
and
says
we
want
you
to
declare
to
us
that
our
current
96
record­
keeping,
electronic
record­
keeping
report,
well,

recordkeeping
is
illegal,
the
agency
is
not
proposing
to
do
that.

The
agency
is
proposing
that
whatever
the
current
status
is,

we're
going
to
....
GPEA
requires
that
we
define
how
that
electronic
reporting
is
going
to
take
place,
and
how
that
electronic
record­
keeping
is
going
to
take
place
in
the
future.

But
I
don't
think,
through
GPEA,
I
mean
through
CROMERRR,
we're
trying,
we're
attempting
to
speak
to
the
past.

Jamie
Conrad:
But
the,
I
mean
there
is,
I
went
back
and
checked
after
you
raised
the
question,
issue
earlier.
GPEA
does
say
that
electronic
record­
keeping
once,
I'm
sorry
that
the
CROMERRR,
once
CROMERRR
becomes
effective,
it
says
that
there
can
only
be
electronic
record­
keeping
where
it's
been
turned
on.
The
turn­
on
thing
is
in
both
reporting
and
recordkeeping
Which
would
suggest
that
all
current
electronic
record­
keeping
practices
would
be
illegal
once
CROMERRR
becomes
effective,
unless
those
are
not
electronic
records
somehow.

David
Schwarz:
I
think
we
talked
a
little
bit
about
that
this
morning.
That
wasn't
the
intent.
And
if
it
turns
out
that
that
is
in
fact
the
effect,
then
we
need
to
reconsider
that.

Jamie
Conrad:
Okay.
I
guess
my
last
question
is,
did
EPA
ever
conduct
the
risk
analysis
that's
discussed
in
the
OMB's
GPEA
guidance
talks
about
doing
a
risk
analysis
of
the
likelihood
of
fraud
and
the
potential
degree
of
harm
if
there
was
fraud
97
versus
the
costs
in
terms
of
money
and
operability
and
the
kinds
of
remedies
that
might
prevent
that.

Male
Participant/
EPA:
Where
our
primary
focus
on
the
risk
analysis
is
(
inaudible)
wide
range
of
(
inaudible)
from
the
record­
keeping
(
inaudible)

Jamie
Conrad:
Is
there
a
document
in
the
docket
somewhere
that
represents
that
risk
analysis?

Male
Participant/
EPA:
I
believe
that
there
(
inaudible)
I'm
not
really
sure.

Evi
Huffer:
GPEA
(
inaudible)

Jamie
Conrad:
Is
it
something
you'd
be
willing
to
put
in
the
docket,
or
is
it
(
inaudible)?

Evi
Huffer:
(
inaudible)

Jamie
Conrad:
Okay,
thanks.

Mark
Duvall:
I'm
Mark
Duvall
with
the
Dow
Chemical
Company.
I
wanted
to
follow
up
on
Howard
Kruger's
comment
about
the
cost
and
the
arithmetic
that
he
did.
I'd
like
to
offer
a
different
view.

According
to
the
EPA
cost
benefit
analysis,
there
are
1.2
million
facilities
with
EPA
reporting
obligations,
either
reporting
to
EPA
itself
or
to
states
and
tribes
and
so
forth.

It
seems
reasonable
to
assume
that
if
there
are
1.2
million
reporting
facilities,
there
are
at
least
that
many
facilities
subject
to
EPA
and
related
record­
keeping
facilities,
record­
98
keeping
requirements.

So
if
we
use
for
working
purposes
1.2
million
as
the
number
of
facilities
which
have
record­
keeping
obligations,
and
if
we
assume
that
all
of
them
use
computers
in
keeping
at
least
some
of
those
records
at
least
some
of
the
time,
then
that's
the
number
that
we
would
multiply
by
whatever
the
cost
of
the
record­
keeping
provisions
would
be.

So
if
we
take
EPA's
cost
benefit
analysis
figures
of
$
40,000
for
an
initial
cost
plus
continuing
costs,
if
we
just
focus
on
the
$
40,000
and
multiply
that
by
1.2
million
facilities,
it
comes
to
a
total
of
$
48
billion,
just
for
the
record­
keeping
piece,
just
for
the
initial
investment.
My
question
is,
in
EPA's
evaluation
of
the
rule,
have
you
done
any
justification
for
a
number
on
that
order
of
magnitude
for
costs?

David
Schwarz:
I
think
the
question
really
goes
ultimately
to
this
question
about
whether
or
not
the
rule
is
voluntary.
From
our
perspective,
at
the
time
we
were
writing
this
rule,
we
understood
that
this
rule
was
voluntary.

And
in
fact,
I
mean
as
a
legal
matter
it
is
voluntary.

With
limited
exception,
very
limited
exception,
electronic
record­
keeping
is
still
voluntary.
So,
I
mean
I
guess
the
issue
is
really,
the
question
that
you're
asking
really
goes
to
the
question
of
whether
or
not
it's
voluntary,
and
the
agency's
99
again
taking
a
look
at
that.

Mark
Duvall:
Thank
you.

Kathleen
Barrowclough:
I
haven't
got
this
one
written
down
ahead
of
time
so
I
may
stumble
a
little
bit.
Kathy
Barrowclough,
DuPont.
And
when
you're
talking
about
electronic
document
receiving
systems,
EPA
puts
certain
criteria
associated
with
an
electronic
document
receiving
system;
these
are
over
and
above
electronic
record­
keeping
requirements.

You've
only
indicated
nine
electronic
record­
keeping
requirements.
And
then
you
also
distinguish
between
and
electronic
record
and
an
electronic
document,
indicating
that
an
electronic
document
is
one
that
is
transmitted
over
the
wires.

And
there
are
specific
requirements
for
electronic
documents
that
are
also
not
applied
to
electronic
records.

When
we
look
at
all
of
those
different
requirements,
we
see
an
opportunity
to
apply
any
of
those
to
electronic
records,
and
we
would
just
like
to,
I
guess,
hear
clarification
from
you
in
that
the
requirements
for
electronic
document
receiving
systems,
which
are
a
robustness
that
we
would
associate
with
our
electronic
record­
keeping
systems,
our
data
collection
systems.

But
you're
not
applying
those
to
electronic
record­
keeping
systems.
Nor
are
you,
there
are
some
particular
things
around
100
electronic
signatures,
in
the
electronic
document
requirements.

You
are
not
also
applying
those
to
electronic
record­
keeping
is
what
it
appears
in
the
rule.
And
I
just
want
a
clarification
from
EPA
on
that.

Male
Participant/
EPA:
Yes,
and
again
I
guess
we
will
have
to
make
sure
that
this
is
absolutely
clear
in
the
final
rule,
but
the
criteria
for
what
we
call
electronic
document
receiving
systems
are
meant
to
apply
to
systems
created
and
maintained
by
state
or
local
agencies
that
operate
a
localized
program
(
inaudible)
allegation.

They
are
not
meant
to
apply
to
companies
that
are
regulated
by
EPA
or
by
these
state
or
local
agencies.
So
in
this
completely
different
universe
of
entities
that
are
being
addressed
by
these
criteria
for
document
receiving
systems.

Paul
Toll:
I'm
Paul
Toll
with
Bayer
Corporation.
And
just
to
kind
of
second
everything
that's
already
been
said
today
from
the
other
companies,
I
was
wondering
since
there
are
so
many
questions,
so
many
uncertainties,
so
many
things
that
you
said
you
had
to
clarify,
would
you
consider
clarifying
those
and
then
open
it
up
for
another
public
commentary?

Male
Participant/
EPA:
(
inaudible)

Kathleen
Barrowclough:
Since
we
seem
to
be
getting
down
to
the
end
of
the
line
here,
Kathy
Barrowclough,
DuPont.
And
what
I'd
like
to
do
is
go
back,
several
people
have
mentioned
about
101
getting
a
group
of
the
right
people,
stakeholders
together,
in
some
sort
of
a
working
group.
And
it's
one
of
the
things
that
the
GLP
community
has
encouraged
over
the
past
year.

We
know
we'd
like
to
participate
as
well
as
probably
several
of
the
other
interested
stakeholders
who
are
here.
And
I
guess
we're
just
wanting
to
hear
something
from
EPA
about
how
and
when
something
like
that
might
go
forward
other
than
just
this
public
meeting
forum,
but
a
working
group
kind
of
meeting.

Evi
Huffer:
This
is
something
that
EPA
can
take
back
and
consider,
but
right
now
we
do
not
have
any
plans
for
such,

performing
such
a
working
group
at
this
time.

Joe
Retzer:
(
inaudible)
public
comment
(
inaudible)
get
the
comments
in
(
inaudible)
a
good
suggestion
(
inaudible)

Michael
LeDesma:
I
guess
just
one
other
point
about
that,
and
that's
why
I
kind
of
turned
the
mike.
If
we
had
such
a
group
in
conjunction
with
the
rule
making,
it
would
probably
need
to
be
constituted
under
something
called
a
federal
advisory
(
inaudible)
...

Evi
Huffer:
Thank
you
very
much.

David
Schwarz:
Thank
you
for
coming.

(
ADJOURN)