Document ID: EPA-HQ-OEI-2003-0001-0257
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-09-20T04:00Z

1
Environmental
Protection
Agency
Office
of
Environmental
Information
Public
Meeting
on
the
Electronic
Record­
Keeping
Provisions
Of
the
Cross
Media
Electronic
Reporting
and
Record­
Keeping
Proposed
Rule
Thursday,
January
17,
2002
Washington,
D.
C.

[
Tape
1
of
3]

Robin
Roberts:
...
of
CROMERRR,
the
Cross
Media
Electronic
Reporting
and
Record­
Keeping
Rule.
Just
to
get
a
sense
of
who's
come
from
out
of
town,
can
I
just
see
a
show
of
hands
to
see
who's
traveled
for
this
meeting?
Wow.
So
most
of
you
have
traveled.
We
appreciate
that.
We'll
try
to
make
this
meeting
as
productive
as
possible.

I'm
Robin
Roberts,
I'm
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's
honored,
that
we
keep
on
time
and
on
track.

The
purpose
of
this
meeting
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
on
the
electronic
record­
keeping
provisions
of
CROMERRR,
Subpart
C.
The
proposed
rule
was
published
on
August
31
of
last
year.
The
public
comment
period
originally
ended
on
November
29
of
last
year.
It's
since
been
extended
twice,
2
currently
until
February
27
of
this
year.
Written
comments
must
be
submitted
to
the
docket
by
that
time.
Instructions
for
submitting
the
comments
are
in
the
FRN
notice,
which
is
available
at
the
front
desk
if
you
don't
have
it.

There
have
been
two
meetings
on
CROMERRR.
We
had
both
of
them
last
year
in
October,
in
D.
C.,
and
in
November
in
Chicago.

While
the
focus
of
those
meetings
were
the
entire
rule,
this
one
is,
just
to
reiterate,
about
Subpart
C,
the
electronic
record­
keeping
provisions.

At
this
time,
I'd
like
to
introduce
the
staff
from
EPA's
Office
of
Environmental
Information
and
Office
of
General
Counsel.
Why
don't
we
just
start
with
you,
Michael.

Michael
LeDesma:
My
name
is
Michael
LeDesma.
I'm
an
attorney
in
the
Office
of
General
Counsel.

Evi
Huffer:
Evi
Huffer,
Office
of
Environmental
Information.

Joe
Retzer:
I'm
Joe
Retzer,
I'm
director
of
the
Collection
Services
Division
in
the
Office
of
Environmental
Information.

David
Schwarz:
I'm
David
Schwarz,
also
in
OEI
and
one
of
the
co­
chairs
of
the
CROMERRR
work
group.

Robin
Roberts:
In
the
audience
planted
among
you
are
other
EPA
operatives,
such
as
Valerie
Brecher­
Kovacevic
and
Connie
Dwyer,
the
chief
of
the
Central
Receiving
Branch.
So
if
3
you'll
turn
to
the
blue
sheet,
your
agenda,
I
would
just
like
to
go
over
that
quickly.
In
the
course
of
conversations
with
some
of
you
last
month,
it
became
clear
that
more
than
hearing
from
EPA
you
wanted
to
engage
the
agency
in
a
discussion
of
your
concerns
about
the
electronic
record­
keeping
provisions
of
the
rule.
This
agenda
is
intended
to
meet
your
request.
After
each
brief
EPA
overview
of
particular
areas
of
the
proposed
rule,
you'll
have
an
opportunity
to
share
your
concerns
with
the
EPA
panelists.

To
foster
your
discussion,
my
colleague,
Jeff
Citrin,
and
I
will
have
a
couple
of
wireless
microphones.
Valerie
may
also
be
doing
this.
We're
going
to
do
the
Phil
Donohue
routine
where
you
have
a
question,
we'll
try
to
get
a
mike
to
you,
and
I
encourage
you
to
speak
up
into
the
mike
so
that
your
comments
do
make
it
onto
the
record.
All
comments
made
into
the
mike
are
being
recorded.
A
transcript
will
be
part
of
the
docket
for
this
meeting,
for
your
review.
We'll
take
as
many
comments
as
the
discussion
period
allows.
I'll
try
to
be
flexible
with
the
agenda.
If
it
looks
like
we're
in
danger
of
running
over
into
another
discussion
area,
maybe
we
can
have
you
jot
down
your
comments
and
we'll
return
to
them
at
the
end
of
the
meeting
if
we
have
any
extra
time.

Let's
just
briefly
go
over
the
groundrules.
When
you
do
speak,
please
state
your
name
and
affiliation,
again,
for
the
4
record.
If
you
could
offer
your
comment
on
the
topic
that's
being
discussed
during
the
time
slots
indicated
on
the
agenda.

Also,
just
a
note
for
some
of
you
who
may
not
have
done
this,

please
sign
in
at
the
front
desk.
I'd
like
to
have
a
complete
record
of
everyone
that
showed
here.
If
you
have
questions
about
the
legibility
of
your
handwriting,
leave
a
business
card.

So
without
further
ado,
I
just
would
like
to
turn
to
David
Schwarz
to
begin
the
first
EPA
overview
on
the
scope
of
the
electronic
record­
keeping
provisions.

David
Schwarz:
Good
morning.
Let
me
add
my
thanks
to
Robin's
for
your
being
with
us
here
today,
particularly
for
those
of
you
who
have
traveled
from
distant
places.
We
really
appreciate
your
taking
the
time
to
help
us
with
this
rule.

What
I'd
like
to
do
for
about
the
next
fifteen
minutes
is
just
go
over
CROMERRR,
focusing
in
on
the
part
that
I
think
we'll
be
talking
about
today;
highlight
what
we
understand
to
be
some
general
issues,
and
I
hope
that
will
launch
the
discussion.

Later
on
in
the
morning,
Evi
will
present
some
more
granular
issues
to
do
with
the
record­
keeping
criteria
in
particular.
Again,
the
purpose
of
that
is
just
to
help
move
the
discussion
along.

I
want
to
start
with
some
general
background
on
CROMERRR.

Most
of
you
are
familiar
with
this,
but
some
of
you
may
not
be.
5
Then
I
want
to
focus
in
on
an
overview
of
the
electronic
record­
keeping
part
of
the
rule,
which
I
should
say
is
Subpart
C,
not
D,
as
we
 
sorry
about
that.
Then
I
want
to
frame
what
we
understand
to
be
some
of
the
general
issues.

CROMERRR
is
meant
to
cover
pretty
much
the
full
range
of
electronic
reporting
and
record­
keeping
under
EPA
regulations.

This
involves
a
broad
range
of
reports
and
records
under
more
than
ten
different
statutory
programs.
It
involves
a
broad
range
of
record
retention
periods
and
requirements,
from
three
to
perhaps
more
than
thirty
years.
In
addition,
as
I'm
sure
most
of
you
know,
most
of
the
implementation
of
our
programs
is
in
fact
carried
out
by
state
or
more
local
agencies.
EPA
may
be
one
of
the
first
agencies
to
address
the
issue
of
electronic
government,
where
there
are
implementations
by
authorized,
more
local
agencies.

Why
do
we
need
a
rule?
Well,
we
think
we
need
a
rule
because
to
actually
offer
electronic
reporting
under
the
Government
Paperwork
Elimination
Act,
agencies
generally
have
to
do
something
affirmative.
They
have
to
set
the
standards
and
parameters
under
which
we
accept
electronic
reports.

Perhaps,
although
this
may
not
be
as
clear,
it
may
be
that
we
have
to
set
the
standards
and
parameters
under
which
we
allow
electronic
record­
keeping.
We
feel
that
we
want
to
do
this
by
way
of
rule­
making,
so
that
the
standards
that
we
do
set
and
6
that
we
think
are
important
are
enforceable
and
clear
and
consistent
across
our
programs
and
across
the
country.
That's
why
we
are
engaging
in
this
rule­
making
exercise.

In
terms
of
applicability,
the
rule,
both
the
reporting
and
record­
keeping
side
of
it,
applies
to
regulated
companies
reporting
to
EPA.
It
will
apply
to
regulated
companies
reporting
under
EPA
regs
but
to
state
or
local
agencies.
It
will
apply
to
regulated
companies
maintaining
compliance
records
and
it
will
apply
to
states
that
are
implementing
electronic
reporting
and
record­
keeping
under
an
authorized
or
delegated
program.
One
thing
that
it
doesn't
apply
to,
it
doesn't
apply
to
transactions
under
administrative
agreements
between
states
or
local
governments
and
EPA.
It
really
addresses
the
interactions,
the
electronic
interactions,

between
the
regulated
companies,
the
regulated
community,
and
government
agencies.

In
terms
of
core
provisions,
the
rule
does
more
or
less
the
following.
To
the
extent
that
there
are
obstacles
in
the
CFR
that
prevent
electronic
reporting
and
record­
keeping,
the
rule
is
intended
to
remove
those.
In
terms
of
electronic
reporting,
the
approach
is
to
require
electronic
reports
be
submitted
to
EPA
systems
or
EPA­
approved
systems.
In
terms
of
obligations
on
regulated
companies
reporting,
the
requirements
really
are
not
much
more
detailed
than
that.
It
does,
7
addressing
the
states
and
local
agencies,
set
performance­
based
criteria
for
state
electronic
reporting
programs.
So
most
of
the
detail
on
the
electronic
reporting
side
is
really
addressed
to
state
or
local
agencies
that
are
implementing
our
programs.

They
aren't
really
addressed
to
regulated
companies
directly.

On
the
record­
keeping
side,
the
rule
sets
standards
for
electronic
record­
keeping.
It
ties
the
approval
of
state
electronic
record­
keeping
and
reporting
initiatives
to
the
general
structure
of
EPA
state
primacy
regs
that
govern
the
way
that
we
authorize
state
and
local
programs.
So
that,
in
a
rather
large
nutshell,
is
what
the
rule
does.

In
terms
of
structure,
it's
laid
out
as
follows.
Subpart
A
is
the
general
provisions.
Subpart
B
focuses
on
electronic
reporting,
[
inaudible]
whether
reports
are
submitted
directly
to
EPA.
Subpart
C,
which
is
where
I
think
we'll
focus
most
of
our
discussion
today,
focuses
on
electronic
reporting
criteria
or
standards
for
companies
maintaining
electronic
records
under
EPA
regs.
Subpart
D
addresses
the
state
or
local
government
dimension
and
deals
primarily
with
what
states
or
local
governments
have
to
do
to
be
able
to
offer
electronic
reporting
or
electronic
record­
keeping.
So
that's
more
or
less
the
structure
of
the
rule.
As
I
said,
we're
going
to
focus
probably
mostly
on
Subpart
C.

So
let's
move
on
to
electronic
record­
keeping.
I'm
not
8
going
to
 
sorry,
I
skipped
ahead
myself
here.
In
terms
of
goals,
the
goals
of
our
electronic
record­
keeping
rule
are
to
allow
industry
to
maintain
electronic
records
in
lieu
of
paper
records,
and
for
EPA
the
sort
of
corresponding
goal
is
to
ensure
that
the
electronic
records
that
are
maintained
by
the
regulated
community
are
as
reliable
and
trustworthy
as
the
corresponding
paper,
so
that
there's
no
loss
in
integrity
or
enforceability
as
we
move
from
the
paper
to
the
electronic
environment.

In
terms
of
scope
and
approach,
the
scope
is
very
broad.

It's
meant
to
address
record­
keeping
by
regulated
companies
and
other
entities
under
pretty
much
all
EPA
and
EPA­
authorized
state
programs,
although
there
is
room
in
the
proposal
to
list
exceptions
or
exemptions.
That's
something
that
if
we
continue
down
that
road,
we
may
end
up
identifying
certain
programs
to
be
exempt
or
excerpted
from
the
CROMERRR
requirements.

In
terms
of
the
approach,
the
approach
is,
what
we
hope
or
intend
it
to
be,
general
function­
based
criteria
for
electronic
records
that
would
ensure
integrity
and
authenticity
of
the
records
being
maintained
but
would
not
dictate
necessarily
particular
technologies.

We
hoped
that
our
record­
keeping
criteria
would
be
consistent
with
existing
compliance
practices
and
existing
electronic
record­
keeping
regulations
and
statutes
to
the
9
extent
that
they
exist.
As
some
of
you
may
know,
the
models
that
we
were
most
cognizant
of
and
that
are
echoed
in
the
proposal
are
the
Food
and
Drug
Administration
electronic
reporting
and
record­
keeping
regs
and
our
own
good
automated
laboratory
practices
guidance
documents.
That
seems
to
be
the
two
predecessors
that
we
were
most
aware
of
and
tried
to
stay
consistent
with.

In
terms
of
the
provisions,
the
general
provision
is
that
we
allow
electronic
record­
keeping
under
any
EPA
program
once
EPA
or
the
particular
EPA
program
announces
that
it's
ready
to
accept
or
allow
electronic
record­
keeping
under
the
regulations
that
it
has
authority
over.
So
for
example,
in
RCRA
recordkeeping
it
would
be
the
Office
of
Solid
Waste
that
might
make
the
announcement
that
they're
ready
to
allow
electronic
records
under
their
regulations.
The
point
of
that
was
simply
that
we
didn't
want
the
publication
of
CROMERRR,
either
on
the
reporting
or
record­
keeping
side,
to
be
like
the
opening
of
a
floodgate
and
force
the
hand
of
programs
that
might
not
be
ready
to
deal
with
whatever
issues
had
to
be
dealt
with.

That's
one
of
the
provisions.

Beyond
that,
so
long
as
 
once
a
program
or
once
EPA
announce
that
electronic
record­
keeping
was
allowed,
so
long
as
the
electronic
record
retention
system
met
the
criteria
in
Subpart
C,
it
would
be
in
compliance
with
CROMERRR.
It
would
10
be
an
acceptable
electronic
record.
So
that's
sort
of
the
general
provision.

There
are
a
couple
of
definitions
that
I
imagine
we'll
be
interested
in
and
come
back
to
in
the
course
of
the
discussion.

One
is
electronic
record,
which
I
believe
we
took
over
from
the
Food
and
Drug
Administration
regs.
I
won't
read
it
to
you,
but
it
is
very
broad,
as
has
been
pointed
out
to
us.
It
may
indeed
be
true
that
any
record
that
at
any
point
in
its
lifecycle
has
passed
through
a
computer
may
in
fact
fall
under
this
definition.
That's
something
we
can
talk
about,
may
be
one
of
the
issues.
There's
also
a
definition
of
electronic
record
retention
systems
and
there's
a
definition
of
electronic
signatures,
and
you
have
those
in
your
handouts
and
also
of
course
in
the
rule
proposal
itself.

Let's
sort
of
focus
in
a
little
bit
more
on
Subpart
C
and
get
a
little
closer
to
the
issues.
Just
in
terms
of
the
overview
of
requirements,
Subpart
C
has
three
main
subsections.

Subsection
A
gives
the
criteria
for
an
acceptable
electronic
record
retention
system.
Subpart
B
addresses
the
issue
of
availability
of
the
system
and
controls
and
documentation
for
inspection.
Subpart
C
adds
some
special
requirements
in
cases
where
electronic
records
involve
electronic
signatures
as
a
part
of
the
record
being
maintained.

All
of
this
has
raised
some
general
issues,
which
I'll
try
11
to
characterize,
although
you're
certainly
free
in
the
discussion
to
recharacterize
the
issues
as
you
see
fit.
There
seems
to
be
a
general
issue
about
current
electronic
recordkeeping
by
companies
and
its
relationship
to
CROMERRR.
One
of
the
questions,
obviously,
is
do
or
could
companies'
current
electronic
records,
electronic
record­
keeping
practices,

satisfy
current
EPA
record­
keeping
requirements.
That
is,

absent
CROMERRR
and
just
looking
at
the
record­
keeping
provisions
that
are
now
on
the
books,
do
electronic
records
satisfy
those?
This
may
be
a
question
one
can
ask.

Similarly,
on
the
state
level,
the
corresponding
question
is
do
companies'
current
electronic
records
satisfy
current
state
program
requirements.
Then
of
course,
perhaps
the
most
interesting
question
is
how
will
CROMERRR
change
the
status
of
current
electronic
records.
So
I
think
those
are
questions
that
we
will
no
doubt
want
to
talk
about.

A
second
set
of
issues
goes
to
the
scope
of
CROMERRR.

Given
the
definitions,
particularly
the
definitions
of
electronic
record,
will
CROMERRR
apply
to
most
or
all
records
kept
for
EPA?
Our
intention
when
we
wrote
the
proposal
was
that
CROMERRR
would
apply
only
to
records
kept
in
an
electronic
record­
keeping
system.
The
perception,
and
I
should
say
that
the
fact
that
I
call
it
a
perception
doesn't
mean
that
it's
necessarily
mistaken,
but
the
perception
is
that
CROMERRR
will
12
apply
to
any
record
that
involves
computers
in
its
lifecycle,

even
if
it
is
now
maintained
on
paper.
To
the
extent
that
this
is
true,
this
is
a
very
troubling
result
and,
again,
one
that
we'd
like
to
explore
how
to
somehow
escape.
Hopefully
you
can
give
us
some
help
on
that.

A
third
general
issue
area
is,
is
CROMERRR
voluntary,

somewhat
related
to
the
previous
two
questions.
The
general
question
is,
will
companies
be
able
to
choose
not
to
comply
with
CROMERRR
standards?
Again,
our
intention
when
we
wrote
the
rule
is
that
the
CROMERRR
standards
be
voluntary
in
the
sense
that
companies
would
have
a
clear
and
meaningful
ability
to
opt
in
or
opt
out
of
electronic
record­
keeping,
as
we
defined
it.

The
perception,
and
perhaps
the
true
perception,
is
that
it
may
not
be
voluntary,
because
given
the
definition
of
electronic
records,
choosing
not
to
do
electronic
recordkeeping
may
mean
choosing
not
to
use
computers
at
all
in
conjunction
with
those
records.
That
just
may
not
be
a
realistic
alternative
for
most
companies.
So
that
clearly
is
an
important
issue
too.

I
guess
the
last
set
of
issues
or
discussion
points
I
would
throw
out
to
you
before
we
turn
things
around
and
hopefully
hear
from
you
all,
is
just
the
scope
of
electronic
record­
keeping.
There
are
a
number
of
ways
to
get
at
this.
I
13
guess
we're
interested
in
what
kind
of
electronic
records
companies
currently
keep
to
satisfy
EPA
regulatory
requirements,
and
how
prevalent
current
electronic
recordkeeping
is.
We're
certainly
very
interested
in
the
kinds
of
systems
that
are
used
to
keep
those
records.
And
of
course,

we're
very
interested
in
whether
there
are
important
distinctions
to
be
made
among
the
kinds
of
records
that
are
kept
electronically
or
might
be,
for
example,
between
the
storage
of
raw
data
and
other
sorts
of
records
that
involve
the
information
later
on
in
the
process.

I'm
going
to
sort
of
break
it
there
in
terms
of
my
remarks,
and
turn
the
discussion
over
to
you.

Robin
Roberts:
Thank
you,
David.
With
these
questions
in
mind,
which
are
meant
more
as
prods
to
encourage
the
discussion
here
but
by
no
means
to
limit
it,
I'd
like
to
take
questions
from
you
here
in
the
audience.
What
kinds
of
records
do
companies
currently
keep
electronically
to
satisfy
EPA
regulatory
requirements?
There
may
be
some
of
you
that
interested
in
responding
to
that
or
have
concerns
about
that,

as
well
as
how
prevalent
are
the
e­
record­
keeping
provisions
and
what
kinds
of
systems
are
used
to
keep
these
records.

Questions?

Evi
Huffer:
Robin?
I
would
just
let
people
talk
about
what
they
want
to
talk
about
within
this
topic.
14
Robin
Roberts:
Yeah,
Evi's
just
reiterating
that
these
questions
aren't
the
only
things
here
to
discuss.
They're
just
meant
to
prod
the
discussion.

Frank
Miller:
Hi,
my
name
is
Frank
Miller
from
Rohm­
Haas
Company.
Been
with
Rohm­
Haas
for
eighteen
years,
variety
of
capacities,
manufacturing,
engineering
and
information
technology.
I
thought
I'd
open
this
up
with
just
sharing
with
you
two
thoughts
that
are
issues
that
are
developing.
We're
studying
this
with
a
cross­
functional
team
internally.

I
guess
the
first
issue
is
the
issue
of
the
breadth
of
impact
on
companies
like
ours.
We
use
a
variety
of
electronic
record­
keeping
systems
and
electronic
systems
to
do
our
compliance
across
all
the
various
media,
air,
water,
waste
and
so
on,
to
do
our
compliance
analysis
reporting
and
so
on.
When
you
multiply
that
diversity
of
systems
by
the
number
of
sites
that
we
have,
that
causes
us
some
pain
in
terms
of
making
sure
that
we
could
come
into
compliance
with
the
criteria
that's
shown
here.

My
own
personal
assessment
is
that
there
would
definitely
be
some
gaps
internally
between
our
current
system's
capabilities
and
the
criteria
that
have
been
shown
here.
So
that's
one
aspect
of
this,
just
the
breadth
of
impact
across
the
company.

Then
there's
the
sort
of
depth
area.
That's
the
number
of
15
systems
that
data
passes
through
before
you
can
do
environmental
compliance.
So
we
have
factory
floor
systems,

those
systems
communicate
then
to
various
other
systems
for
data
logging
and
so
on.
Those
things
potentially
get
passed
to
business
systems.
Eventually
somewhere
up
there,
in
and
around
the
data
analysis
layer,
environmentalists
within
the
company
get
information
from
various
sources,
put
that
together
with
business
logic
and
create
the
analysis
and
eventually
reports.

I
can't
think
of
many
instances
where
we're
not
using
electronic
systems
and
record­
keeping
systems
to
develop
our
reports.
Potentially
the
report
might
be
paper­
based
when
it's
delivered,
and/
or
electronic,
but
internally
a
variety
of
systems
and
data
sources
are
being
used
to
do
the
reporting.

The
challenge
for
us
is,
where
do
you
draw
that
line?

What
is
really
the
electronic
record­
keeping
system?
So
you
can
perceive
that
if
you're
monitoring
the
opacity
of
something
going
up
a
stack
that
all
the
systems
that
that
information
passes
through
potentially
are
electronic
records.
So
that
is
a
source
of
concern
for
us,
how
deep
do
we
go.
So
I
wanted
to
share
those
two
aspects
of
this.

Kathleen
Roberts:
Good
morning,
my
name
is
Kathleen
Roberts.
I'm
with
the
American
Chemistry
Council.
Just
to
give
some
sort
of
explanation
or
overview,
ACC
has
developed
a
document
that
we
refer
to
as
the
Regulatory
Records
Retention
16
Requirements
document.
We
finished
it
and
we've
published
it.

In
retrospect,
however,
we
recognize
that
a
number
of
regulations
are
missing
from
this
document.
For
example,

[
Federal
Insecticide,
Fungicide
and
Rodenticide
Act]
was
not
included.
Some
of
the
Clean
Air­
NESHAP
requirements
were
not
included.
Title
V
was
not
included.

Notwithstanding,
there
are
almost
130
separate
regulations
that
require
records
to
be
retained.
Again,
as
Frank
had
pointed
out,
under
the
perception
or
interpretation
of
CROMERRR,
all
the
data
points
that
supported
the
reporting
for
those
130
regulatory
requirements
potentially
would
also
have
to
be
retained.
So
a
copy
of
this
will
be
delivered
to
EPA.
I
think
we
might
have
left
a
draft
copy
with
EPA
at
the
last
workshop.
But
we
do
have
a
list
of
the
requirements
as
well.

So
it
is
quite
huge.

Bruce
Adler:
Bruce
Adler,
General
Electric
Company.
GE
is
a
global
company
with
350,000
employees.
To
manage
our
environmental
health
and
safety
requirements,
we
have
to
use
electronic
record­
keeping.
Just
as
one
example,
one
of
the
items
that
we
track
is
regulatory­
required
training,
of
which
there
were
over
a
million
units
delivered
in
2001.
That
has
to
be
done
electronically.
Why?
Because
it's
the
only
way
we
can
efficiently
and
effectively
and
reliably
track
the
information.

If
we
reverted
to
a
paperwork
system
to
track
those
17
requirements,
it
would
collapse.
We
would
collapse,
we'd
be
wasting
time
and
money,
and
it
wouldn't
be
as
reliable.

The
whole
issue
that
I'm
concerned
with
with
this
rule
is
that
by
virtue
of
the
requirements
you're
imposing,
to
make
it
like
 
allegedly
like
 
paperwork
you're
destroying
the
one
element
of
electronic
record­
keeping
that
is
so
useful,
which
is
its
reliability.
You're
making
it
more
like
paper
than
like
electronic
record­
keeping.
We
could
say
that
if
we
were
looking
for
100
percent
reliability,
so
that
you
could
have
a
perfect
audit
trail,
that
we
could
etch
all
of
our
training
requirements
when
they're
conducted
in
stone.
That
way
we'd
know
if
anybody
tried
to
change
them.
Obviously,
we're
not
going
to
do
that.
That's
going
back
to
the
past,
to
a
less
reliable,
less
effective
system.
The
virtue
of
electronic
record­
keeping
of
any
form
is
its
effectiveness,
is
its
speed,

is
its
reliability.

What
we're
doing
here,
what
it
seems
like
you're
trying
to
do
here,
is
to
torque
the
system
to
catch
that
infinitesimally
small
percentage
of
those
electronic
records
which
might
be
collected
or
preserved
in
a
fraudulent
way.
And
to
do
that,

you're
imposing
on
the
billions
of
other
records
that
are
collected,
a
system
that
makes
it
a
less
effective
and
less
useful
system.

Robin
Roberts:
If
there
are
any
comments
here
to
any
18
particular
concerns
you
hear
voiced,
please
speak
up.

David
Keyes:
I'm
David
Keyes
with
the
Environmental
Technology
Council.
We're
the
trade
association
for
the
commercial
hazardous
waste
industry.
I'm
still
not
clear,
and
it's
probably
just
because
I
haven't
gotten
up
to
speed
enough,

on
your
intended
applicability
of
this
proposed
regulation.

David,
rather
than
my
kind
of
just
making
a
general
comment,

I'm
actually
going
to
ask
a
specific
question
and
see
if
I
can
get
an
answer
that
helps
clarify
the
applicability
of
the
regulation.

If
you
think
of
a
typical
commercial
hazardous
waste
facility,
a
landfill
or
an
incinerator,
I
think
of
kind
of
three
tiers
of
electronic
record­
keeping
that
goes
on
at
that
facility.
One
is,
as
described
by
some
of
the
other
commenters,
electronic
data
collection
that
is
ultimately
assembled
into
a
report
that
is
filed
either
electronically
or
on
paper,
but
has
that
electronic
data
collection
trail
behind
it.
Perhaps
some
of
the
requirements
you've
suggested
would
be
easier
to
apply
at
that
very
high
level
of
collection.

Secondly,
there
are
a
variety
of
regulation­
required
records,
like
personnel
training
records,
as
this
gentleman
described,
where
it's
all
recorded
and
maintained
electronically,
subject
to
frequent
change
as
training
is
upgraded
and
new
employees
are
added
and
so
forth.
19
Then
there
is
the
layer
of
almost
minute­
by­
minute
electronic
recording
of
information.
For
example,
when
a
drum
comes
in
the
gate
it
has
a
bar
code
and
that
drum
is
tracked
through
the
entire
processing
at
the
facility,
in
its
storage,

in
its
treatment,
in
its
ultimate
disposal.
The
drum
itself,

when
it's
empty,
it's
eventual
discarding
is
all
tracked
electronically,
because
by
EPA
or
state
regulation
we
have
to
be
able
to
show
at
that
facility
where
that
drum
is
at
any
point
in
time
in
its
processing.

Similar
to
that
are
just
various
monitoring
results
that
are
recorded
electronically.
An
incinerator
has
a
literally
second
by
second
recording
of
all
its
various
emissions.
Of
course,
it's
really
not
practical
to
keep
that
on
paper,
or
to
even
produce
it
on
paper.
When
EPA
inspects
those
records,
it
typically
looks
at
the
electronic
records.
In
fact,
a
lot
of
the
monitoring
data
is
tied
right
into
EPA
computers.
They
can
track
the
data
in
their
offices,
in
the
EPA
regional
offices
or
state
offices.

So
we're
just
completely
unclear
at
which
layer
do
these
record­
keeping
requirements
apply.
If
they
apply
all
the
way
down
to
the
most
minute
data
that's
collected
in
enormous,

enormous
volumes,
that
obviously
is
going
to
impose
tremendous
problems
for
us
in
trying
to
comply
with
all
those
requirements.
20
So
could
you
answer
 
I
guess,
not
to
go
on
for
too
long,

but
just
as
another
idea.
Your
paper
says,
when
EPA
announces
it's
ready
for
electronic
record­
keeping,
this
rule
will
apply.

EPA
hasn't
announced
anything
but
we're
keeping
all
these
records
electronically.
So
I'm
not
sure
what
that
means
either.

Thanks.
Sorry
for
the
long
question.

Robin
Roberts:
Would
you
like
a
reply
to
that
now?

David
Schwarz:
Let
me
do
my
best
and
if
I
mess
up
maybe
my
colleagues
can
help
me.
You
really
asked
two
questions.

One
is,
what
was
our
intention
in
terms
of
the
applicability
of
our
electronic
record­
keeping
requirements.
Let
me
start
to
answer
that
by
posing
a
kind
of
conundrum
to
you,
which
is
that
we
did
not,
in
CROMERRR,
actually
define
the
term
"
record."

The
reason
that
we
didn't
do
that
is
because
our
intention
was
that
we
wanted
CROMERRR
to
apply
to
records
as
defined
and
specified
in
the
range
of
so­
called
predicate
regulations
in
the
CFR.

So
a
record
may
mean
one
thing
under
a
particular
[
inaudible]
regs,
it
may
mean
something
else
in
terms
of
Clean
Water
Act,
for
example,
National
Pollutant
Discharge
Elimination
System
regs,
and
so
on
and
so
forth.
I
couldn't
sit
here
today
and
tell
you
exactly
what
record
means
under
each
of
those
regs,
because
I
don't
know
enough
about
all
the
21
details
of
all
the
different
programs.

I
think
that
perhaps
creates
a
problem
for
us,
because
our
intention
was
that
we
wanted
CROMERRR
to
apply
to
those
records,
as
these
were
specified
in
the
various
regulations,

when
and
to
the
extent
that
those
particular
records
were
kept
in
an
electronic
record­
keeping
system.
I
don't
know,
to
be
perfectly
honest,
whether
that
intention
as
I've
articulated
it
is
one
that
is
a
particularly
clear
one,
although
I
think
it's
only
become
clear
to
us
as
a
result
of
some
of
these
discussions
that
there
is
this
problem.
Record
may
mean
many
different
things.

We
certainly
did
not
mean
to
encompass
all
possible
records
or
anything
that
might
be
meant
by
a
record,
but
what
exactly
we
do
mean
may
require
that
we
go
back
and
do
more
work
looking
specifically
at
particular
program
regs.
I
don't
know
if
that
answers
your
question,
but
at
least
shares
our
sense
of
the
problem.

In
terms
of
the
idea
that
individual
EPA
programs
would
announce
that
electronic
record­
keeping
was
turned
on,
again,

all
I
can
do
is
sort
of
explain
to
you
the
assumptions
under
which
we
were
working
when
we
wrote
that,
which
turn
out
not
to
be
valid.
Which
is
that
we
assumed
that
generally,
except
for
rather
specific,
a
handful
of
programs
where
electronic
recordkeeping
had
been
specifically
provided
for,
our
assumption
was
22
that
companies
were
not
generally
keeping
the
records
required
under
the
program
regs,
however
those
are
defined.

Our
assumption
is
that
those
records
were
not
being
maintained
electronically.
What
you
all
have
been
telling
us
here
today
and
at
previous
meetings
is
that
assumption
is
not
true.
So
clearly,
that
provision
of
CROMERRR
will
have
to
be
changed
or
dropped.

It
looks
as
though
electronic
record­
keeping
generally,

and
this
is
where
my
Office
of
General
Counsel
colleague
may
want
to
jump
in,
but
it
looks
as
though
in
general
electronic
record­
keeping
is
not
clearly
prohibited
by
existing
regulations,
except
maybe
in
some
special
cases
where
there
are
specific
references
to
paper
or
paper­
related
things.
If
that's
the
case,
as
it
may
well
be,
then
we're
starting
at
a
different
point
in
the
evolution
of
the
transition
than
we
thought
we
were
and
we'll
have
to
say
different
things.

Michael
LeDesma:
I
can
just
add
a
little
bit
to
that.
I
think
 
one
of
the
questions
we've
heard
often
is
why
do
you
even
need
a
rule
to
allow
electronic
record­
keeping
when
it's
clear
that
under
many
of
your
programs,
in
fact,
electronic
record­
keeping
is
currently
being
allowed.
I
think
that
when
we
look
at
this
rule,
like
many
of
the
other
rules
that
the
agency
promulgates,
there're
really
two
components.

One
is
an
interpretive
component
and
then
there's
a
23
legislative
component.
For
some
programs
in
the
agency,
the
agency
has,
as
a
matter
of
just
fact,
accomplished
that
interpretive
step
through
guidance.
But
in
most
instances
it
hasn't.
So
there
is
an
interpretive
step
that
needs
to
be
made
before
electronic
record­
keeping
is
"
turned
on."
In
addition,

and
what's
creating
a
great
deal
of
the
controversy,
are
the
legislative
elements,
the
provisions
that
we
see
in
Section
3.100
of
the
rule.

So
there
are
really
those
two
components.
I
think
the
intention
of
this
rule
is
not
to
speak
to
current
recordkeeping
but
to
make
clear
that
we
are
doing
this
interpretive
step
and,
in
addition,
this
legislative
step,
so
that
it's
clear
for
everybody
what
the
rules
of
the
game
are
going
forward.

Rich
Lysakowski:
I'm
Rich
Lysakowski
from
two
organizations,
actually,
the
Collaborative
Electronic
Notebook
Systems
Association
and
the
Global
Electronic
Records
Association.
I've
been
studying
this
problem
since
about
1991,

and
what
it
takes
to
replace
paper
notebooks
and
notebook
systems
with
electronic
records.
We've
come
to
some
basic
conclusions
that
computer
systems
are
not
record­
keeping
systems,
they're
data
systems.

Data
is
not
equivalent
to
a
record,
and
you
have
to
be
pretty
formal
about
how
you
define
what
is
a
record.
That
is,
24
a
record
is
something
that
is
converted
to
a
preservation
format
that
will
outlive
the
computer
systems
of
today,
and
set
aside
under
the
duty
of
care
of
a
custodian
who
has
accountability
and
responsibility
for
preservation
of
that
record.

CENSA,
Collaborative
Electronic
Notebook
Systems
Association
focuses
on
two
things;
one
is
regulatory
compliance,
because
notebooks
are
used
for
regulatory
recordkeeping
The
second
is
intellectual
property
protection,
which
is
an
even
more
stringent
 
when
it
comes
to
litigation,
the
litigation
is
a
free­
for­
all.
It's
not
a
well­
ordered
type
of
litigation
you
encounter
with
the
Environmental
Protection
Agency.
It
is
a
total
free­
for­
all,
going
for
the
throat,
this
is
my
intellectual
property
and
I'm
going
to
get
it
no
matter
what.
So
that's
a
different
kind
of
record­
keeping,
requires
an
even
higher
level
of
integrity
in
the
whole
process,
from
beginning
to
end.

The
way
the
rule
is
written
now,
I
implore
you
to
define
a
record
as
a
record,
not
the
way
it's
defined
here
as
anything
created
by
a
computer
system.
That
is,
first
of
all
focus
on
converting
it
to
a
preservation
format,
something
that
will
outlive
the
current
computer
system
that
you
bought
tomorrow,

which
was
obsolete
yesterday.

First
and
foremost;
this
is
critical.
Do
not
equate
25
computer
systems
to
records
retention
systems.
Do
not
equate
people
who
create
data
to
a
records
manager
or
an
archivist,

that
is,
someone
with
the
duty
of
care
for
records
to
be
retained
for
as
long
as
they're
needed
by
the
business.

We
found
this
 
in
CENSA
we
have
a
lot
of
pharmaceutical
companies,
we
have
tons
of
money
to
pour
into
the
[
Federal
Drug
Administration]
Part
11
legislation.
We
have
some
of
your
companies
represented
in
CENSA
as
well,
if
you're
a
chemical
company.
We
found
that
it
just
takes
a
lot
of
time
and
money
to
bring
any
system
into
compliance.
It's
not
just
the
hardware
and
software,
it's
your
whole
program
of
people,

policies,
education,
training
and
all
of
those
things.

If
you
don't
start
upfront
with
using
the
right
definitions,
given
the
way
computer
systems
have
been
designed,

they're
not
designed
to
be
records
retention
systems.
They're
used
for
just
capturing
and
processing
information
and
data.

And
data
and
information
are
not
the
same
as
a
record.
If
you
look
at
the
most
formal
definition,
that
is,
one
used
by
the
archival
community,
it's
something
converted
to
a
preservation
format
and
set
aside
for
the
purpose
of
preservation
for
as
long
as
needed
by
the
business.
So
there's
some
fundamentals
that
ought
to
be
put
in
here.

If
you're
going
to
keep
the
rule
the
way
it
is,
I
suggest
you
change
the
name
to
Electronic
Evidence
Rule.
Because
this
26
is
indeed
the
heart
of
the
matter,
that
yes,
the
way
you've
defined
electronic
records
is
anything
coming
from
a
computer
system.
The
way
that
evidentiary
discovery
is
done
is
anything
from
any
computer
system.
Correct?
It's
all
evidence,
no
matter
where
it
is,
no
matter
what
form.
So
include
in
there
electronic
evidentiary
discovery
aspects
of
it.

Don't
call
it
just
records,
call
it
evidence,
because
that's
where
we
got
a
lot
of
confusion
in
trying
to
comply
with
Part
11
from
the
[
Federal
Drug
Administration].
The
[
Federal
Drug
Administration]'
s
rule
was
not
about
records,
it
was
not
about
things
created,
converted
to
a
preservation
format
and
set
aside
under
the
duty
of
care
with
somebody
who
knows
how
to
do
that.
It
was
really
about
evidence,
anywhere
and
everywhere,
and
going
after
that
evidence
for
the
purpose
of
criminal
prosecution,
for
the
purpose
of
demonstrating
fraud.

That's
really
what
this
rule,
that's
one
of
the
things
this
rule
is
intended
to
do
is
to
cover
evidentiary
discovery
for
prosecution.

So
that
should
be
made
clear
too,
that
this
is
about
electronic
evidence,
it's
not
about
electronic
records.
It's
not
only
about
electronic
records.
It's
about
reporting
to
the
EPA,
it's
about
taking
records
from
computer
systems
and
putting
them
into
record­
keeping
systems
or
records
retention
systems.
It's
about
permitting
EPA
to
come
in
and
do
27
evidentiary
discovery
for
purpose
of
prosecution.
But
a
few
fundamental
changes,
and
one
even
includes
somewhere
in
the
name
the
word
"
evidence,"
not
 
[
End
of
Tape
1,
Side
A;
Side
B
begins]

­­
or
information.
I'm
not
really
quite
sure,
because
I
can't
get
a
straight
answer
from
my
records
manager
or
someone
like
that,
someone
qualified.
So
this
issue
of
duty
of
care
for
preservation
comes
in.
That
needs
to
be
really
clear
in
the
rule.
With
a
few
fundamental
changes,
you
can
set
expectations
properly
as
to
what
it
will
take
to
comply
with
the
rule.
It's
a
much
bigger
issue
than
you
really
understand
at
this
time.
It's
taken
us
almost
ten
years
now
to
really
fully
understand
the
implications
of
trying
to
throw
away
paper
for
high­
consequence
and
high­
value
records.
It's
not
about
the
name,
it's
about
the
processes
of
evidentiary
discovery,

that
we
found
that
are
critical.

There's
attorneys
sitting
in
this
room
who
will
never
move
away
from
paper
until
they
have
the
same
kind
of
comfort
and
confidence
in
"
computer
systems,"
that
they're
equal
to
recordkeeping
systems,
because
they're
not,
not
the
way
computer
systems
are
designed
today.
I
can't
read
Microsoft
Word
Version
2
files
with
Microsoft
Office
2000.
It's
simply
unavailable
as
a
converter
today.
So
the
software
and
the
formats
are
also
a
critical
issue.
28
Jonnie
Martin:
My
name's
Jonnie
Martin,
I
work
for
a
downstream
oil
company
that
you've
probably
never
heard
of,
but
it's
a
Shell­
Texaco
joint
venture
called
Equilon
and
Motiva.
I
work
for
Equiva
Services,
which
is
the
central
EHS
organization.
We
manage
environmental
regulations
for
nine
refineries,
over
a
hundred
petroleum
distribution
terminals,

several
thousand
service
stations
and
thousands
of
miles
of
pipeline.
In
our
company,
everyone
has
a
computer,
everyone.

This
rule
would
have
a
significant
impact
on
us
for
a
couple
of
reasons.
One,
because
my
office
is
in
Houston
and
we
have
severe
air
problems
in
Houston,
as
most
of
you
know,

companies
there
are
being
encouraged
strongly
to
go
to
telecommuting.
My
company
is
fixing
to
institute
a
strong
telecommuting
policy
which
would
allow
us
to
work
from
home
three,
possibly
four
days
a
week,
and
only
come
into
downtown
Houston,
which
would
be
a
blessing,
once
a
week.

To
do
that,
we're
spending
several
hundred
thousand
dollars,
perhaps
millions,
I
don't
know
the
total
cost,
but
I
know
it
is
significant,
with
our
Intranet
web
site.
The
company
aims
that
that
web
site
will
be
used
by
all
of
us
to
do
our
work
from
home.
So
therefore
all
the
environmental
information
has
to
be
in
the
computer
and
has
to
be
accessible
to
every
employee
who's
working
from
home,
to
every
refinery,

to
every
terminal,
to
every
pipeline
operator.
29
The
rule,
as
it
is
now
written
would
cost
us
significant
amounts
of
money,
if
we
could
even
comply
with
it,
and
quite
frankly,
we
don't
think
we
can.
So
I
would
very
much
agree
with
the
gentleman
over
there.
Your
definition
of
electronic
record
is
so
broad
that
it
captures
everything
we
do
now.
I
would
urge
you
to
reconsider
this
one.

Howard
Krueger:
My
name
is
Howard
Krueger
from
Procter
&

Gamble
Company
in
Cincinnati.
I
have
worked
in
the
regulatory
affairs
field
for
twenty­
eight
years
and
have
worked
in
the
legislative
arena,
the
regulatory
arena.
I've
been
before
Congress,
regulatory
agencies
and
the
courts.
I'm
very
familiar
with
definitions
and
how
they're
interpreted.

The
brief
comment
that
I
have
really
for
Joe,
I
want
to
play
back
the
comment
that
Joe
made
where
he
said
that
they,

meaning
the
EPA,
had
not
provided
a
definition
of
record.
What
I'd
like
to
alert
you
to
is
the
very
high
likelihood
that
in
fact
you
have.
I'll
explain
it.
You
have
clearly
defined
an
electronic
record,
and
if
you
take
off
the
word
electronic
and
if
you
remove
the
last
four
words,
which
are
"
by
a
computer
system,"
you
have
in
fact
defined
a
record,
and
I'll
read
it
to
you.
It's
right
here
in
your
definition.
"
A
record
is
any
combination
of
text,
graphics,
data,
audio,
pictorial
or
other
information
that
is
created,
modified,
maintained,
archived,

retrieved
or
distributed."
The
only
thing
that
makes
it
30
electronic,
putting
the
word
electronic
at
the
beginning,
are
the
last
four
words
that
say
"
by
a
computer."
So
I
would
just
caution
you
in
thinking
that
you
haven't
defined
a
record,
just
because
the
word
record
doesn't
appear
by
itself.
I
would
say
that
you
have.
Then
when
you
define
electronic
record
of
course
you
use
the
big
four
words,
"
by
a
computer
system."

Jim
Scialabba:
I'm
Jim
Scialabba
with
Marathon
Oil
Company.
One
issue
with
this
proposed
regulation
that
I
have
not
heard
brought
up
yet
in
any
public
forum
or
in
any
correspondence
I've
seen
is
the
implications
on
this
rulemaking
for
the
relationship
that
we,
the
regulated
community,

would
have
with
all
government
entities
because
a
lot
of
the
information
that's
gathered
is
gathered
by
our
field
people,

our
technicians,
our
managers,
who
aren't
environmental
professionals.
They
gather
information
also
that
is
passed
on
to
or
which
we
need
to
submit
to,
for
instance,
OSHA
and
Department
of
Labor,
U.
S.
Fish
and
Wildlife
Service,
Bureau
of
Land
Management,
MMS,
Army
Corps
of
Engineers,
U.
S.
Coast
Guard,
National
Marines
Fishery
Service
and[
the
National
Oceanic
and
Atmospheric
Administration],
in
addition
to
state
agencies
that
are
environmental
agencies
or
analogues
of
federal
agencies.

A
concern
we
have
is
that
this
rule­
making
is
going
to
set
a
standard
that's
going
to
change
the
relationships,
reporting
31
relationships,
with
all
of
these
agencies.
Because
we're
not
going
to
create,
for
instance,
us,
who
like
everyone
else
in
the
room
is
heavily
dependent
on
electronic
management
of
information
now,
we're
not
going
to
set
up
a
system
that's
only
going
to
comply
with
EPA.
We're
going
to
have
[
inaudible]
set
a
standard
that
will
work
across
the
company
because
our
people
want
to
use
a
single
system,
as
we've
gone
to
a
single
word
processing
standard
in
the
company.

I
really
think
EPA
needs
to
consider
this.
If
you
haven't
talked
with
your
colleagues
in
the
other
government
agencies,
I
really
urge
you
to
sit
down
and
have
a
discussion
about
this
very
broad
implication.

James
VanHorn:
I
am
Jim
VanHorn
with
Smurfit­
Stone
Container
Corporation.
The
question
was,
how
is
this
going
to
affect
and
how
much
record­
keeping
do
we
have
being
covered
by
this.
In
our
company,
there
is
a
definite
push
to
get
all
the
records.
It
includes
such
things
as
our
financial
records,

quality
records,
production
records,
human
resource
records,

our
purchasing
sales
and
of
course
environmental.
An
awful
lot
of
these
indirectly
are
the
initial
sources
where
data
is
collected.
It
ends
up
in
a
report.

As
an
example
of
how
this
is
going
to
affect
us
in
our
company
audit,
today
it
is
rather
easy
to
get
money
and
material
to
store
in
electronic
record­
keeping.
But
if
you
ask
32
for
a
new
file
cabinet,
they
look
at
you
like
something
that's
crazy.
So
it
has
a
tremendous
effect
on
us,
it
can
affect
practically
everything
we
do,
is
that
we're
totally
going
towards
the
electronic
record­
keeping,
documentation,

everything
we
do.
So
it
will
affect
everything
that
we
do
in
the
whole
corporation.

Maria
Angelo:
I'm
Maria
Angelo,
I
work
for
DuPont.
I'm
in
our
corporate
solid
waste
consulting
group.
I'd
like
to
thank
you
for
the
opportunity
to
talk
this
morning
and
discuss
these
issues.
I'd
just
like
to
reiterate
the
comments
that
other
folks
from
industry
have
been
saying
with
respect
to
the
prevalence
of
the
use
of
electronic
records
today.
Even
if
you
try
and
narrow
your
definition
to
focus
only
on
records
as
they
apply
to
specific
programs,
they're
still
used
extensively
to
support
permits,
to
support
records.

Just
to
reiterate
what
this
gentleman
said
with
respect
to
the
origin
of
the
systems,
I
know
at
one
facility
in
the
United
States
I
counted
 
in
ten
minutes
I
was
able
to
come
up
with
over
three
dozen
different
systems
that
are
used
to
support
the
collection
of
information
for
environmental
compliance.
That
doesn't
cross
into
some
of
the
other
program
areas
that
have
been
mentioned
or
some
of
the
other
business
programs
that
have
been
mentioned,
and
that's
only
one
facility.
Certainly
each
facility
does
a
lot
of
hybridization
and
uses
different
33
systems,
so
the
scope
is
just
massive.

Mark
Duvall:
My
name
is
Mark
Duvall
with
the
Dow
Chemical
Company.
The
initial
question
was,
what
kinds
of
records
are
kept
electronically
by
our
companies
and
what
kinds
of
systems
are
used.
Dow,
like
the
other
companies
that
have
been
mentioned,
uses
many
kinds
of
electronic
systems
for
many
different
purposes.
For
our
compliance
with
EPA
recordkeeping
virtually
everything
we
do
is
at
some
point
electronic.
Sometimes
things
are
printed
out,
but
to
a
large
degree
they
are
not.
Virtually
nothing
that
we
do
is
not
at
some
point
electronic.

It's
interesting
to
note
that
the
cost­
benefit
analysis
that
was
done
for
this
rule
suggested
that
annually
428
facilities
in
the
United
States
would
choose
to
subject
themselves
to
this
rule.
That
suggests
that
there's
a
fundamental
misperception
here,
that
electronic
record­
keeping
is
at
the
dawn
of
its
use
in
the
American
economy.
It's
obviously
not
the
case.
At
one
Dow
facility,
for
example,
over
a
million
data
points
are
collected
annually.
Air
emissions,

water
emissions,
these
are
data
that
can
only
be
collected
by
computers,
can
only
be
stored
by
computers,
can
only
be
manipulated
by
computers.
The
idea
that
we
would
even
choose
ever
to
print
them
out
is
not
only
inefficient,
but
we
wouldn't
know
what
to
do
with
the
paper,
because
we
couldn't
use
the
34
data
other
than
in
electronic
format.
Electronic
recordkeeping
is
the
norm,
it
is
pervasive,
it
is
throughout
Dow
and
I
would
suggest
throughout
all
facilities
that
are
regulated
by
EPA.

How
do
we
keep
electronic
records?
The
answer
is,
in
lots
of
different
ways.
There
is
no
standard
way
that
we
use
electronic
records.
Our
agricultural
chemical
subsidiary,
for
instance,
uses
some
180
different
systems
to
collect
electronic
data
for
laboratory
and
field
studies.
We
have
over
ten
thousand
laboratory
instruments,
many
of
which
are
standalones
Our
R&
D
function
has
a
diverse
computing
architecture
that
has
almost
every
kind
of
proprietary
system
out
there
being
utilized.
So
we
have
Windows
and
we
have
UNIX
and
inhouse
systems.
There
is
no
standardization,
and
frankly
that
sometimes
gets
in
the
way
as
we
try
and
move
data
from
one
system
to
another
system.

But
if
the
question
that
EPA
is
asking
is,
is
there
a
way
that
records
are
kept
one
way
or
a
few
ways
that
records
are
kept
such
that
a
rule
could
be
tailored
to
address
those
systems,
the
answer
is
no.
There
are
many,
many
different
systems
used
today
and
there
is
no
standardization
to
them.
A
few
things
that
could
be
said
about
those
systems,
however,
is
that
they
were
not
designed
with
the
CROMERRR
record­
keeping
requirements
in
mind,
so
that
for
example,
an
audit
trail
35
capability
will
sometimes
be
found
in
these
systems
but
generally
will
not
be.

One
reason
for
that
is
that
the
functionality
is
not
needed,
it's
not
a
business
need.
You
don't
want
to
pay
for
a
feature
that
you
didn't
need.
As
a
result,
all
of
the
infrastructures
that
we
have
lack
the
capability
of
meeting
the
CROMERRR
requirements.

In
addition,
the
whole
point
of
electronic
record­
keeping,

the
whole
point
of
using
computers,
is
to
increase
efficiency.

To
the
extent
that
the
kinds
of
data
that
EPA
would
like
to
see
retained
in
the
form
of
audit
trails,
what
the
effect
of
that
would
be
a
tremendous
increase
in
the
memory
requirements,

because
so
many
more
data
points
would
need
to
be
saved.

Memory
is
expensive.
It
is
one
of
the
single
most
expensive
aspects
of
the
computer
system.
When,
as
Dow
has,

you
have
very
large
systems
with
very
large
quantities
of
data,

to
have
to
exponentially
increase
the
amount
of
data
kept
and
then
keep
it
for
considerable
periods
of
time,
the
memory
costs
themselves
are
a
very
significant
aspect
of
the
cost
of
meeting
the
CROMERRR
electronic
record­
keeping
provisions.

Pat
McConnell:
I'm
Pat
McConnell
from
DuPont.
I
just
wanted
to
add
one
additional
piece
to
what
this
gentleman
just
said.
The
most
impossible
piece
of
this
is
you
were
talking
about
individual
applications
that
do
audit
trails.
Almost
all
36
of
our
companies
don't
use
one
application
to
get
data
from
Point
A
to
Point
B.
Lots
of
times
the
data
collection
system
doesn't
do
the
analysis,
doesn't
do
the
reporting.

One
thing
that
is
not
possible,
that
we
cannot
force
the
vendors
to
do,
is
to
create
the
means
by
which
to
produce
audit
trails
between
the
systems
and
interfaces
between
the
systems
that
provide
or
meet
the
guidelines
in
CROMERRR.

Patricia
Runge:
I'm
Patricia
Runge
and
I
work
at
Experimental
Pathology
Laboratories
in
Virginia.
We're
not
involved
in
a
lot
of
the
larger
scale
applications
that
CROMERRR
would
bring
to
our
industry.
We're
toxicologic
pathology.
But
a
lot
of
the
same
applications
apply
with
the
electronic
record­
keeping
and
electronic
generation
of
data.

But
one
thing
that
I
don't
get
from
anybody,
either
from
EPA
or
from
[
Federal
Drug
Administration],
is
how
hybrid
systems
are
going
to
be
considered
in
this
application.

For
many
smaller
companies,
that
includes
environmental
as
well
as
toxicological
companies,
a
lot
of
their
data
is
not
generated
by
a
computer
but
it
does
go
through
a
computer
system
for
reporting
purposes
and
for
data
retention
purposes.

There
are
not
enough
guidelines
as
how
this
type
of
application
needs
to
be
addressed.

Austin
Perez:
Austin
Perez
from
the
U.
S.
Small
Business
Administration's
Office
of
Advocacy.
The
gentleman
from
37
General
Counsel
earlier
addressed
I
guess
the
need
for
the
rule
and
I
wanted
to
address
this
question
to
you.
I've
been
told,

and
I'm
hearing
over
and
over
again,
that
electronic
recordkeeping
is
widespread.
I
believe
you
were
making
a
legal
distinction
that
the
fact
that
it's
being
allowed
was
allowed
through
guidance
rather
than
through
a
change
of
the
law.
I
guess
I'm
curious.
I
guess
what
you're
suggesting
is
that
if
you
don't
do
this
rule,
I
guess
to
turn
on
the
ability
to
record­
keep
is
a
problem.
I
would
like
to
know,
what
are
the
consequences
if
this
rule
does
not
go
into
effect,
in
all
those
situations
where
electronic
record­
keeping
is
allowed
today?

Michael
LeDesma:
I
guess
there's
probably
 
I'm
not
sure
what
the
programmatic
consequences
are,
although
I
suspect
that
what
you'd
end
up
with
if
the
agency
were
to
proceed
in
the
absence
of
a
rule
like
CROMERRR
is
that
each
program
would
design
its
own
set
of
 
each
EPA
program,
in
fact
each
federal
agency
program
that
somehow
affects
a
regulated
entity,
would
develop
its
own
electronic
record­
keeping
requirements,
that
they
would
require
through
guidance.
Then,
of
course,

companies
such
as
yourselves
would
be
or
the
companies
represented
here
would
be
in
the
position
of
having
to
comply
with
that
multiplicity
of
different
systems.
So
I
think
one
of
the
motivations
behind
CROMERRR
was
to
create
a
unified
set
of
record­
keeping
requirements.
38
As
a
legal
matter,
I'm
not
going
to
speak
to
what
the
 
I'm
not
going
to
speak
generally
to
ongoing
record­
keeping
practices
throughout
the
agency.
I
don't
know
about
them
in
sufficient
detail
to
speak
one
way
or
the
other.
But
I
will
say
as
a
general
matter
that
the
agency
can
allow
electronic
record­
keeping,
in
fact
there
are
several
regulations
that
the
agency
has
where
it
says
that
the
agency,
the
administrator
can
designate
an
electronic
record­
keeping
system.
So
we
can.
The
fact
of
the
matter
is
that
we
haven't
done
so
in
any
sort
of
widespread,
coherent
sort
of
way.
So
that
was
the
intent
of
this
rule.

Howard
Krueger:
Howard
Krueger,
Procter
&
Gamble.
I
wanted
to
respond
with
some
more
examples
of
specific
records.

I
think
it
is
helpful
to
really
come
to
grips
with
exactly
what's
involved.
I
have
this
in
text
form
and
I'll
give
it
to
you
at
the
break.
Under
the
broad
definition
of
an
electronic
record,
our
company
cannot
identify
a
single
instance
where
some
aspect
of
the
compliance
records
creation
or
modification,

maintenance,
archiving,
retrieval,
distribution,
does
not
involve
a
computer
system.

We
currently
keep
hundreds
of
thousands
of
electronic
records
each
year
under
[
the
Federal
Insecticide,
Fungicide,

and
Rodenticide
Act,
Toxic
Substances
Control
Act],
Clean
Water
[
Act],
Clean
Air
[
Act],
[
Comprehensive
Environmental
Response,
39
Compensation
and
Liability
Act]
and
[
Resource
Conservation
and
Recovery
Act].
Specific
examples
of
the
kinds
of
records,

which
was
the
question
that
was
originally
asked,
include
analytical
data
and
summaries,
product
performance
data
and
summaries,
testing
protocols,
animal
and
human
subjects
testing
and
summaries
 
speak
to
the
point
made
over
here.
[
Good
Laboratory
Practices]­
GCP
compliance
information,
production
records,
raw
material
receipt
and
usage,
[
Quality
Assurance]

records,
production
data,
training
records,
import
and
export
compliance
records;
entire
databases
of
miscellaneous
information
which
are
subsequently
used
to
conduct
and
support
compliance
assessments;
domestic
shipping
information
and
many
other
hundreds
of
thousands
of
records.

In
addition,
examples
of
the
electronic
records
specifically
created
and
maintained
at
our
manufacturing
facilities
include
emission
or
surrogate
emission
data
from
a
distributed
control
system,
and
that
is
a
sensor
combined
with
a
computer
that
automatically
records
the
data.
Continuous
emission
monitor
data,
computer­
generated
documents
and
spreadsheets
used
to
calculate
and
document
emissions
data.

Chemical
use
inventory,
records
under
[
the
Toxic
Substances
Control
Act]­
IUR,
which
are
taken
from
electronic
materials
management
systems.
Environmental
logs
are
created
from
instrument
data,
which
is
often
averaged
over
a
compliance
40
period
and
recorded
on
an
electronic
log.

So
in
summary,
virtually
all
of
our
records
are
in
fact
electronic
records.
We
cannot
identify
how
the
CROMERRR
rule
would
not
impact
this
entire
universe
of
our
electronic
recordkeeping
system
and
the
records
that
we
have.

Charles
Reese:
Charles
Reese
with
BASF
Corporation.
I
just
agree
with
Mr.
Krueger
of
Procter
&
Gamble
and
several
of
the
other
people
here
that
the
kinds
of
records
that
companies
currently
keep,
virtually
we
keep
all
records
electronically
or
they
pass
through
some
sort
of
electronic
record­
keeping
system
at
some
point
of
their
life.
If
you
were
to
look
at
just
Part
160,
there
are
57
required
records
inside
of
simply
Part
160
under
Title
XL.
Companies
like
to
use
computers
and
electronic
records
extensively
to
take
advantage
of
efficiencies
wherever
that's
possible.
Examples
of
these
types
of
records
that
are
ideal
for
maintaining
electronically
could
be
anything
from
standard
operating
procedures,
personnel
training
records,

master
study
schedules,
draft
reports,
calculation
reports.

Even
raw
data
can
be
generated
and
maintained
electronically
under
the
provisions
of
the
Good
Laboratory
Practice
Standards.

BASF
is
a
large,
multinational
company.
We
have
many
diversified
business
groups
that
have
different
applications
and
responsibilities
under
EPA's
Title
XL
environmental
regulations.
We
recognize
the
need
for
regulations
and
41
guidance
around
these
practices
concerning
electronic
reporting
and
record­
keeping.
At
this
time,
though,
we
feel
that
the
record­
keeping
portion
of
the
proposed
rule
should
be
withdrawn.
The
reasons
for
this
opinion
are
four
statements.

I'm
going
to
give
you
this
text
at
the
break.

As
it's
written,
the
CROMERRR
proposed
rule
is
not
voluntary.
It
would
be
mandatory
for
any
EPA­
regulated
entity
that
currently
generates
an
electronic
record.
The
number
of
entities
affected
and
the
cost
to
develop
compliance
procedures
are
grossly
underestimated.
Estimates
run
as
high
as
1.2
million
entities
affected
immediately,
and
could
have
an
effect
on
the
economy
ranging
from
anywhere
from
$
48
billion,
and
then
we've
heard
as
high
as
$
1.8
trillion.
This
differs
greatly
from
the
400
average
number
of
facilities
per
year
and
the
$
40,000
average
per
facility
cost
to
comply.

Third,
there's
no
differentiation
between
types
of
electronic
records,
but
rather
a
one­
size­
fits­
all
approach
for
all
of
the
electronic
record
criteria.
This
approach
gives
no
consideration
to
the
vastly
different
types
of
systems
currently
in
use
to
adhere
to
Title
XL.
Finally,
the
rapid
changes
in
technology
force
a
huge
burden
on
maintaining
an
electronic
record
for
a
long
record
retention
period,
which
in
some
cases
can
last,
as
you
said,
decades,
up
to
thirty
years
or
more.
In
this
case,
would
actually
be
indefinite.
42
Robin
Roberts:
If
possible,
we
have
set
aside
a
time
on
the
agenda
to
talk
to
this
whole
issue
of
decoupling
Subpart
C.

I
would
just
beg
your
indulgence
and
try
withholding
comments
on
that
until
we
get
to
that
section.

Kathleen
Roberts:
Kathleen
Roberts,
American
Chemistry
Council.
David,
perhaps
you
can
help
me
with
this.
A
couple
slides
back
you
talk
about
the
scope
of
CROMERRR
and
the
intention
was
CROMERRR
would
apply
only
to
records
kept
in
an
electronic
record­
keeping
system,
and
then
the
perception,

which
is
the
one
that
we've
all
reiterated
here,
that
in
fact
we're
reading
it
to
mean
every
piece
of
data
collected
in
order
to
comply.

I'd
like,
and
beg
my
indulgence
if
you
would,
can
you
redefine
electronic
record­
keeping
system?
Because
the
way
that
it's
written
right
now,
quite
frankly,
I
just
don't
get
it.
The
way
it's
written
right
now
says,
"
any
set
of
apparatus,
procedure,
software,
records
or
documentation
used
to
retain
exact
electronic
copies
of
electronic
records."

Electronic
and
record
is
repeated
a
couple
of
times
in
there,

so
I'm
just
not
really
sure
what
it
is
exactly
that
means.

David
Schwarz:
I
don't
think
I
want
to
try
to
redefine
this
on
the
fly.
I
think
this
was
also
something
that
we
borrowed
from
[
the
Federal
Drug
Administration].
Let
me
ask
you,
is
there
 
43
Kathleen
Roberts:
I
guess
what
I'm
wondering
is,
when
you
guys
talk
about
record­
keeping
systems
and
whether
they
are
or
are
not
allowed
by
EPA,
and
obviously
many
people
here
are
keeping
records
electronically
and
so
we're
all
kind
of
at
angst
going,
what
exactly
does
this
mean?
When
you
say
EPA
may
allow
electronic
records,
do
you
mean
electronic
copies
of
the
reports?
Is
that
what
we're
referring
to?

David
Schwarz:
No,
no.
I
think
I
can
answer
this
question.
Under
most
EPA
regs
that
involve
some
sort
of
informational
requirement,
there's
pretty
standardly
a
distinction
between
data
you
actually
have
to
submit
to
EPA,

that's
the
report,
and
things
that
you
have
to
maintain
at
your
facility,
which
you
may
never
have
to
submit
but
you
might
for
example
need
to
make
available
if
an
inspector
calls.
The
record­
keeping
requirements
are
meant
to
pertain
to
those
things
that
you
have
to
maintain
at
your
facility.

There
is,
I
suppose,
an
overlap
in
the
sense
that
very
often
one
of
the
records
you
have
to
maintain
is
a
copy
of
the
report
that
you
submitted,
although
not
always.
So
there's
that
overlap.
But
the
record­
keeping
is
meant
to
focus
on
what
you
keep
at
your
facility
and
don't
submit
to
us.

Kathleen
Roberts:
So
those
records
that
you
are
required
to
maintain
for
EPA.

David
Schwarz:
Right.
What
they
are
really
varies
widely
44
from
program
to
program,
as
you
know,
I'm
sure.

Kathleen
Roberts:
Agreed.
Okay,
then
I
guess,
as
has
been
stated
many
times,
I
think
we
need
to
reiterate
what
the
definition
of
record
is
and
if
it
requires
a
separate
definition
for
each
regulation,
maybe
that
is
something
to
consider.

Henry
Bartholomew:
Henry
Bartholomew
of
the
Edison
Electric
Institute.
Just
to
speak
to
the
issue
on
the
table
at
the
moment,
I
would
also
say
that
for
electric
utilities,

electronic
record­
keeping
is
very
pervasive
and
we're
certainly
affected
by
many
of
the
programs
EPA
administers
and
a
lot
of
our
company
monitoring
and
reporting
is
done
electronically.
I
think,
although
I
know
you
want
to
sort
of
divide
this
into
little
subpieces,
as
I
listen
to
the
discussion
this
morning
and
your
presentation
and
I've
read
the
preamble
to
the
rule
while
I'm
sitting
here,
it's
about
trying
to
have
trustworthy
data­
keeping.

When
companies
file
reports,
they're
required
to
file,
or
if
they
have
an
inspector
on
site
taking
a
look
at
what's
happening
on
a
particular
site,
the
issue
of
trustworthiness
is
inherent
in
the
filing
of
the
report,
when
they
sign
off
on
that
report,
whether
you
have
a
paper
trail
behind
it
or
an
electronic
data­
keeping
system.
With
things
like
the
U.
S.

Sentencing
Commission
guidelines
and
EPA
pronouncements
in
the
45
various
program
areas,
most
of
our
companies
have
very
advanced
environmental
compliance
systems
in
place
that
a
part
of
which
is
the
electronic
record­
keeping,
but
it's
just
a
part
of
it.

This
feels
like
that
tail
trying
to
wag
the
dog.

If
EPA
has
identified
specific
concerns
that
it
wants
to
address,
rather
than
trying
to
revamp
the
entire
electronic
record­
keeping
system
that
many
companies
have
been
putting
in
place
at
many
hundreds
of
thousands
of
dollars
over
the
past
couple
of
decades
since
computer
technology
really
became
available,
let's
look
at
what
are
those
specific
concern
areas
and
let's
address
those
much
more
individually.
Individually
may
mean
if
you
have
a
bad
actor
company,
you
may
deal
with
it
directly
in
that
case
by
imposing
some
restrictions
on
that
company.
But
as
a
general
matter
in
terms
of
major
U.
S.

industries
in
the
U.
S.
economy,
it
seems
like
this
is
a
very
upside­
down
approach
to
trying
to
deal
with
that
issue
of
reliability
and
so
forth.
When
a
company
files
a
report
and
signs
off
on
it,
it's
standing
behind
that,
presumably.
That's
just
an
observation,
thanks.

Kathy
Barrowclough:
Kathy
Barrowclough,
DuPont.
I'd
like
to
go
back
to
what
Ms.
Roberts
was
just
saying
around
the
exact
electronic
copies
in
electronic
record­
keeping
systems.
That's
been
a
question
of
mine.
The
electronic
records
requirements
that
you
spell
out,
the
different
ones
that
you
have
for
audit
46
trail
and
that
sort
of
thing,
according
to
the
rule
apply
to
those
records
that
are
maintained
in
an
electronic
recordkeeping
system.
Then
if
you
go
back
and
look
at
the
definition
of
an
electronic
record­
keeping
system,
it
refers
to
records
that
are
exact
copies
of
data.
When
in
reality
a
lot
of
our
record­
keeping
systems
are
the
original
raw
data,
they
are
not
copies.
So
the
question
is,
what
are
we
applying
to?
Are
we
applying
to
all
of
those
data
collection
systems
or
are
we
only
applying
the
electronic
record­
keeping
portion
or
rules
to
those
systems
that
we
have
set
up
to
maintain
in
an
ongoing
way
those
copies
of
those
original
records
or
original
data
points?

Robin
Roberts:
We're
going
to
take
one
last
question
and
then
there's
been
a
request
for
a
quick
break
after
this
question.
I'd
like
to
have
you
back
here
in
ten
minutes.
The
doors
will
be
locked
at
that
time.

Bruce
Adler:
I
want
to
return
to
the
issue
that
Mr.

LeDesma
addressed
earlier,
and
that
has
to
do
with
the
present
status
of
electronic
records.
I'm
certainly
in
favor
of
consistency
between
the
programs
as
to
how
they
approach
electronic
record­
keeping.
But
the
thrust
of
your
words
implied
that
without
CROMERRR
and
without
guidance
from
the
various
program
offices,
there's
some
sort
of
impediment
to
electronic
record­
keeping.
I'm
not
sure
that's
the
case.

Absent
a
specific
prohibition
on
tracking
records
47
electronically,
I
don't
think
that
the
agency
can
say
we
can't
do
that.
Just
like
the
agency's
rules
do
not
currently
distinguish
between
keeping
records
with
a
pencil
or
a
pen
or
a
manual
typewriter
or
an
electric
typewriter
or
a
word
processor,
there's
no
prohibition
on
keeping
them
electronically.
So
the
implication
that
absent
CROMERRR
and
absent
guidance
from
the
program
offices
that
electronic
records
can't
be
used,
I
think
is
just
wrong.

Robin
Roberts:
Great.
With
that
comment
then,
we'll
break
now
before
we
take
up
the
overview
on
the
general
criteria
for
the
record­
keeping
provisions.
So
I
could
have
you
back
here
in
ten
minutes,
that's
11:
35.

[
Break]

David
Schwarz:
I
want
to
sort
of
drill
down
to
the
specific
criteria
in
this
part
of
the
discussion.
These
are
the
nine
criteria.
I'm
not
going
to
go
through
all
of
them
in
detail,
I
think
probably
you're
pretty
familiar
with
them.
For
whatever
it's
worth,
I
guess
my
feeling
is
that
some
of
them
are
reasonably
straightforward
and
perhaps
not
quite
so
controversial.
For
example,
the
first
one,
"
generate
and
maintain
accurate,
complete
records
in
a
form
that
cannot
be
altered
without
detection."
That
may
or
may
not
be
something
that's
easy
to
comply
with,
but
the
general
idea
that
one
should
maintain
accurate
records
and
that
there
should
be
a
way
48
to
detect
if
they've
been
messed
with
or
doctored,
is
I
think
reasonably
straightforward.

Some
of
the
others
I
know
are
more
controversial.
We
are
going
to
focus
on
the
archiving
and
the
audit
trail
criteria
specifically
this
afternoon.

There
have
been,
in
past
meetings
and
comments,
a
considerable
amount
of
focus
on
those,
and
so
we
do
want
to
devote
some
time
specifically
to
them.

In
the
case
of
records
with
electronic
signatures,
there
are
some
additional
criteria.
We
feel
that
where
the
signature
is
present
there
should
be
some
information
to
allow
someone
reading
the
record
to
determine
what
the
signature
meant,
whose
signature
it
is,
date
and
time,
things
like
that.
And
there
should
be
a
way
to
link
the
electronic
signature
to
the
electronic
record
in
a
way
that
ensures
that
it's
bound
and
cannot
be
pulled
apart,
it
cannot
be
excised
or
that
ideally
what's
signed
can't
be
changed
without
in
some
way
invalidating
the
signature.
That's
pretty
much
the
criteria.
I'm
sure
we'll
talk
about
some
of
these
points
in
more
detail.

Just
one
last
slide
in
terms
of
discussion.
Some
of
the
questions,
but
by
no
means
all
of
them,
that
we
like
to
have
talked
about
here
are,
first
of
all,
which
criteria
are
the
most
difficult
to
satisfy
with
existing
systems.
I
guess
to
the
extent
that
people
can
be
specific
about
what
in
particular
49
causes
the
problem
I
think
would
be
very
helpful
to
us.

Similarly,
if
some
criteria
pose
particular
problems
for
certain
kinds
of
records,
I
think
that
would
be
useful.

People
have
pointed
out
this
morning
and
in
other
sessions
that
there
is
a
problem
with
a
one­
size­
fits­
all
approach,
and
if
you
can
tell
us
where
in
fact
this
one
size
does
not
fit,

again,
I
think
the
specifics
would
be
very
useful.

I
think
a
third
question
is,
if
in
fact
these
criteria
are
not
ones
that
you
currently
adopt
and
satisfy,
we
would
be
interested
in
knowing
how
you
currently
do
assure
yourself
and
other
people
who
are
interested
that
your
electronic
records
are
in
fact
accurate
and
reliable
and
have
integrity.
We're
very
interested
in
alternative
sets
of
standards
to
these
things,
if
you
could
propose
them.
Then
I
guess
if
there
are
unique
issues
that
you
see
associated
with
electronic
signatures
that
form
a
part
of
electronic
records,
we'd
certainly
like
to
hear
that
as
well.

So
that's
at
least
some
of
the
questions
that
we
hope
you'll
respond
to.
Of
course,
any
others
that
you
are
interested
in
talking
about.

Robin
Roberts:
Good,
so
this
is
a
little
more
narrowly
focused
section.
We've
gotten
to
the
depth
and
the
breadth
of
a
lot
of
the
issues
here
associated
with
record­
keeping
and
also
with
record
retention.
If
in
this
section
we
could
try
50
and
be
a
little
more
focused
on
particular
general
criteria,

that
would
be
great,
and
it's
also
a
chance
for
you
to
let
EPA
hear
about
how
you
manage
your
record­
keeping
systems
and
what
are
some
of
the
problems
you've
encountered
that
would
inform
your
development
of
a
realistic
rule.

Mark
Greenwood:
My
name
is
Mark
Greenwood
and
I'm
with
the
law
firm
Robson
Gray.
I
represent
something
called
the
Coalition
for
Effective
Environmental
Information.
Actually,

I'm
afraid
I'll
divert
a
little
bit
from
the
specific
question
point
if
I
could,
because
I
think
in
listening
to
the
discussion
this
morning,
I
think
following
this
rule­
making,
I
think
we're
struggling
with
the
difficulty
of
trying
to
sort
through
three
different
constructs
for
what
the
agency
is
trying
to
achieve.
If
I
could
just
go
through
that
I
think
it
might
be
helpful,
at
least
it
organizes
things
for
me,
if
it
doesn't
for
others.

I
think
the
agency
is
in
some
sense
trying
to,
really
under
the
authority
of
[
the
Government
Paperwork
Elimination
Act],
which
is
the
statute
which
is
supposed
to
allow
and
permit
record­
keeping
and
reporting
to
be
electronic,
to
somehow
do
something
that
makes
it
clear
that
that's
allowed.

I
heard
Michael
saying
that
there
was
this
interpretive
function
to
make
clear
in
a
rule
that
things
that
people
have
been
doing
for
many
years
are
okay.
I
think
that
is
a
function
51
that
they're
trying
to
deal
with
here,
and
I
think
that
is
a
separate
issue
from
two
others.

The
other
theme
I'm
hearing
here
is
they're
concerned
about
fraud
in
how
documents
are
prepared
and
perhaps
modified
over
time.
I
would
suggest
that's
a
very
different
problem,

and
I
think
there's
a
lot
of
folks
who
have
strong
feelings
about
what
is
the
nature
of
that
problem,
whether
it
is
a
problem,
and
so
on.
I
think
it's
very
important
to
focus
initially
on
what
is
the
nature
of
that
issue,
if
there
is
one,

because
it
drives
everything
related
to
solutions
and
obviously
paths
forward
for
the
rule.

The
third
one,
which
is
this
issue
of
long­
term
record
retention,
which
I
think
people
recognize
is
an
issue.
How
you
manage
it,
frankly
it's
a
problem
not
just
for
the
private
sector,
for
the
government
as
well.
It
relays
a
lot
of
questions
about
what
are
the
records
and
why
do
we
retain
them
for
such
a
long
period
of
time.
Again,
a
distinct
set
of
issues
and
problems
that
I
think
should
be
thought
through
on
separate
tracks.

So
while
I
know,
I
suspect
we'll
have
a
very
open
discussion
about
many
of
these
issues
here,
I
think
it's
helpful
for
us
all
to
keep
in
mind
that
we
have
three
different
problems
that
will
define
both
what
is
the
issue,
what
is
the
solution
and
what
is
the
path
forward
as
we
go
through
today.
52
Robin
Roberts:
Great.
Any
organizational
scheme
for
all
these
ideas
that
are
flowing
is
a
good
idea.
Are
there
any
questions
on
the
general
criteria
of
the
rule
that
you'd
like
to
speak
to?
Any
experience
with
record­
keeping
in
your
corporations
that
you'd
like
to
share?

Frank
Miller:
Frank
Miller
again,
from
Rohm­
Haas
Company.

Just
to
give
you
ideas
for
some
comments
back
on
the
various
criteria.

So
four
comments.
On
the
systems
that
we
have
in
general,

whether
they're
used
for
compliance
and/
or
business
systems
and
so
on,
in
general
the
first
point,
being
able
to
absolutely
detect
any
times
that
data
could
be
altered,
most
systems
aren't
really
designed
that
way.
They're
secured
and
there's
various
roles
of
who
can
do
what
and
role­
based
security
as
systems
have
evolved,
but
to
absolutely
detect
when
any
changes
are
made
and
so
on
and
that
records
haven't
been
altered,
most
of
our
systems
aren't
really
designed
that
way.
So
that's
the
first
aspect.
There's
definitely
a
gap
between
maybe
what
your
ultimate
disciplined
intentions
are
here
and
what
we
could
probably
do
today.

The
second
area
is
around
audit
trails,
time
and
date
stamping
and
so
on.
Some
systems
have
those,
many
business
systems
have
it
so
that
you're
not
really
changing
the
exact
information,
you're
doing
incremental
changes
to
it
and
have
53
some
kind
of
time
and
date
stamping.
But
by
and
large,
most
of
the
environmental
systems
don't
have
too
much
of
that,
and/
or
if
they
use
business
systems,
they
inherit
some
of
that.
But
in
general,
most
systems
weren't
designed
that
way
and
that's
not
usually
there,
so
we'd
have
to
find
a
way
of
bringing,

again,
coming
into
compliance.
So
that's
point
six
and
seven.

Point
eight,
around
searching
and
retrieving.
Probably
most
systems
today
are
starting
to
adopt
knowledge
managementtype
principles
where
you
want
to
be
able
to
find
things
easily
and
fastly
and
have
keyword
criteria
and
various
ways
to
get
at
information.
But
again,
not
too
many
systems
are
there
yet,
so
again
there's
a
gap.
It'll
take
us
a
while
to
come
into
compliance.

Then
around
the
archiving
in
electronic
form,
there's
two
parts
to
that.
The
storage
media
itself,
so
there's
storage
media
obsolescence.
There's
the
challenge
of
always
being
able
to
have
it
on
the
right
media
so
that
you
have
that
equipment
to
be
able
to
bring
it
back
if
someone
needed
to
see
it.

Then
the
application
obsolescence
­­
that's
being
able
to
have
it
on
a
platform
where
you
have
people
who
know
how
to
run
that
platform
and
know
how
to
understand
the
application,

understand
business
logic
and
could
actually
run
the
application
ten
years
later
to
be
able
to
understand
how
that
record
was
actually
generated.
54
So
again,
those
things
are
a
challenge
for
us
today.
We
don't
have
real
good
answers
for
those.
The
storage
media,
we
do
bring
things
forward
and
so
on,
but
there's
always
the
issue
of
the
first
recording
of
data
and
how
do
you
 
you
can
validate
data
as
you
move
it,
you
can
validate
applications
as
you
move
it,
but
there's
always
the
issue
of
now
you've
moved
beyond
the
first
 
[
End
of
Tape
1,
Side
A]

[
Tape
2
of
3]

­­
those
are
some
feedback
on
those
criteria.

Rich
Lysakowski:
If
I
look
at
the
list
of
 
I
would
assume
these
are
functional
criteria
for
electronic
records
retention
system.
You've
got
nine
commandments
there.
Going
back
to
biblical
terms,
there's
usually
ten.
If
you
could
just
add
one,
and
that
is,
convert
records
to
a
documentary
record
form
that
permits
facile
 
in
quotes,
I
have
facile
means
low
cost
 
migration
of
records
before
the
underlying
technology
becomes
obsolete.
Then
you
would
have
a
complete
system
for
records
retention.
The
things
that
he's
talking
about
are
programmatic
elements
that
are
people,
policies,
procedures,

not
technology
functional
requirements.

So
adding
a
tenth
part
to
that,
convert
records
to
a
documentary
record
form
that
permits
low­
cost
migration
of
records
before
the
underlying
technology
becomes
obsolete,
55
would
give
you
a
complete
functional
description
of
the
system,

at
least
from
the
technology
point
of
view.
That's
the
real
issue
around
retention,
is
the
rapid
obsolescence.

Today
that's
by
design,
so
that
you
are
forced
to
upgrade
to
the
next
version
of
software.
Vendors
really
make
that
difficult
for
you
to
do
facile
conversion
to
some
preservation
format
that
makes
migration
easy.
That's
where
your
real
cost
comes
in
over
long
periods
of
time
with
electronic
records
systems,
is
because
vendors
make
that
difficult
on
purpose.

Unidentified
Male
Speaker:
Or
maybe
it's
really
Bill
Gates
that
makes
that
difficult.

Pat
McConnell:
I'd
like
to
add
just
one
dispute
to
that,

and
I'm
not
sure
if
I'm
crossing
over
into
this
afternoon.
But
long
term,
thirty
years
from
now,
do
you
know
how
many
versions
of
how
many
systems
of
how
many
instruments
of
how
many
software,
and
if
they
have
to
be
converted
I
won't
have
to
do
it,
I'll
be
retired
by
then.
But
if
every
form
of
that
has
to
be
converted,
that
becomes
massive
in
itself.

Charles
Reese:
I
just
want
to
add
a
comment
to
the
gentleman
from
the
computer
notebooks.
This
is
the
[
Good
Laboratory
Practices]
consensus
document,
the
application
to
the
principles
of
[
Good
Laboratory
Practices]
to
computerized
systems,
by
the
[
Organization
for
Economic
Cooperation
and
Development],
series
on
principles
of
[
Good
Laboratory
56
Practices]
and
compliance
monitoring.
In
this
document,
they
actually
give
commandment
number
ten,
"
where
system
obsolescence
forces
a
need
to
transfer
electronic
raw
data
from
one
system
to
another,
then
the
process
must
be
well­
documented
and
its
integrity
verified.
Where
such
migration
is
not
practical,
then
the
raw
data
must
be
transferred
to
another
medium"
 
medium
being
a
key
word
here
 
"
and
this
verified
as
an
exact
copy
prior
to
any
destruction
of
the
original
electronic
records."

The
tenth
commandment
needs
to
be
a
medium.
A
medium
doesn't
have
to
be
paper.
It
could
be
paper.
It
doesn't
have
to
be
a
computer
format.
It
could
be
a
computer
format.
But
the
key
is
medium.
When
something
is
electronic,
we're
trying
to
store
it
as
a
record,
and
it
becomes
obsolescent,
we
need
to
have
the
ability
to
move
that
record
to
some
medium.
Our
choice
in
[
Federal
Insecticide,
Fungicide
and
Rodenticide
Act],

up
until
this
point,
had
been
paper.
The
way
we
see
these
definitions
of
electronic
records
is
going
to
make
our
paper
systems
 
we
will
no
longer
be
able
to
say
that
our
original
raw
data
is
the
paper
printout,
because
the
electronic
record
is
first.

So
my
question
here
is
actually
to
the
panel,
is
more
the
issue
of
fraud.
I
see
here
in
this
list
of
the
nine
commandments
things
that
seem
to
point
to
how
to
maintain
these
57
records
with
integrity
over
periods
of
time,
but
there's
nothing
there
to
say
that
how
the
records
were
generated
in
the
first
place.
Were
they
 
is
the
record
accurate
or
is
it
maintained
properly.
So
I
guess
the
issue
here
is
validation.

So
how
is
CROMERRR
going
to
address
the
fraud
 
is
there
some
sort
of
feeling
that
without
CROMERRR
that
the
ability
to
perpetuate
fraud
is
greater
or
less?
I
wonder
how
you
plan
to
address
these
things
and
how
come
we're
not
addressing
whether
or
not
the
data
is
actually
accurate
versus
how
long
we
maintain
it,
or
how
we
maintain
it.
Just
open
to
the
panel.

Unidentified
Male
Speaker:
I
guess
I'd
say
two
things
about
it.
One
is,
the
first
one
does
say
generate
and
maintain
accurate
records.
I
think
the
other
thing
is
again,
we're
looking
at
the
underlying
program
requirements
to
describe
what
record
you
have
to
generate
and
how
it
can
be
generated.

Whether
it
says
you
can
use
a
CEM
or
whatever
it
is.
Usually
the
underlying
program
records
requirements
describe
that.
So
that's
why
we
didn't
address
the
generation,
the
initial
generation
of
the
record
here,
other
than
the
more
general
statement
that
you
have
to
generate
accurate
records.

Unidentified
Male
Speaker:
Does
that
answer
your
question?

Charles
Reese:
Yeah.
So
you're
saying
that
the
individual
programs
here
have
their
own
requirements
for
58
generating,
the
way
they
generate
an
accurate
record,
but
if
we're
all
generating
electronic
records,
are
the
programs
then
going
to
have
to
address
individually
how
to
generate
an
accurate
electronic
record
versus
 
then
we
have
to
rely
on
CROMERRR
to
how
we
maintain
and
migrate
that
electronic
record.

So
wouldn't
it
seem
prevalent
to
have
some
sort
of
validation
concept
in
the
CROMERRR?
Because
you're
right
back
to
what
it
seemed
like
you
were
trying
to
avoid,
having
the
individual
programs
create
their
own
systems
for
how
you
generate
an
electronic
record
accurately.

If
everybody
has
to
come
up
with
their
own
validation
scheme,
then
you've
got
a
whole
set
of
programs
going
this
is
the
right
way
to
validate,
this
is
the
right
way
to
validate,

this
is
the
right
way
to
validate,
but
everybody
has
to
follow
CROMERRR
to
maintain.
Just
something
to
point
out.

Barbara
Foy:
My
name
is
Barbara
Foy,
I'm
from
Monsanto
Company.
I
wanted
to
make
a
comment
about
the
first
couple
of
points
up
on
the
screen
about
the
various
criteria
and
their
impact
on
business.
While
I
think
there
are
issues
around
most
of
the
criteria,
by
far
and
away
one
of
the
most
troubling
ones
for
us
in
the
way
we
do
business
is
number
nine,
the
archival
issue.
Archiving
these
records
we
would
see
as
a
major,
major
change
in
the
way
we
do
business,
a
major
expense
for
the
way
we
do
business.
I
just
want
to
make
a
comment
about
our
59
current
practice,
which
is
paper­
intensive
at
this
point.

So
just
to
echo
some
of
the
comments
that
have
been
made
just
before
mine,
I'd
like
to
reinforce
and
go
on
the
record
as
agreeing
with
those
comments,
with
the
hurdles
that
the
archiving
portion
of
the
CROMERRR
requirements
would
cause
for
a
business
like
ours.
Particularly
the
requirement
that
requires
these
records
to
be
preserved
with
their
context,
meta
data,
in
the
exact
electronic
form
that
they
were
created
for
years
and
years
and
years
into
the
future
would
present
a
huge
problem
and
a
huge
expense.

John
Chellen:
I'm
John
Chellen
from
HRI.
I
didn't
get
the
gentleman's
name
sitting
at
the
table
up
here,
but
I
thought
he
put
his
finger
on
one
of
the
key
aspects
of
this
issue.
I
think
it's
especially
important
because
it
clearly
appears
that
there's
a
consensus
that
EPA
is
certainly
overreaching,
perhaps
inadvertently
so,
in
trying
to
freeze
an
incredible
amount
of
data
that's
upstream
of
what's
the
most
critical
information
and
clearly
downstream
of
where
it
all
begins.

It
seems
that
we
should
perhaps
separate
this
into
two
subsidiary
questions.
The
first
is,
the
most
important
transaction
that
occurs,
the
most
important
record,
is
the
one
that's
delivered
to
EPA.
How
is
that
legitimized,
how
do
we
verify
that
the
person
who
sent
it
is
the
person
who
said
they
60
are,
and
is
it
accurate.
Once
EPA
has
received
a
record
of
that
nature,
EPA
has
it.
It
seems
that
we
can
shift
the
burden
of
retention
of
that
record
to
EPA.
Through
the
legal
principle
of
estoppel,
that
if
it
is
made
public,
if
that
transaction
is
turned
around
to
the
original
respondent,
the
respondent
can
be
put
in
the
position
of
either
agreeing
or
disagreeing
that
this
is
the
transaction
that
occurred.
End
of
discussion
at
that
point,
if
there
is
a
certain
time
period
for
them
to
agree.
I
submitted
this,
it
is
accurate,
and
after
a
period
of
time
they
are
given
no
further
opportunity
to
question
that
transaction.

Nobody
except
EPA
needs
to
maintain
that
record
any
further,
except
in
the
following
circumstance,
which
I
think
this
other
gentleman
pointed
out.
Was
this
reflective
of
the
primary
business
activity
and
who
was
responsible
for
the
generation
of
that
record,
accurately
or
not?
It
seems
that
we
do
not
need
to
keep
every
single
intermediate
transaction
or
intermediate
record
that
is
used
to
create
that
final
record,

but
we
need
to
maintain
the
original
source
data.
We
need
to
maintain
an
accurate
statement
of
the
process
by
which
that
transaction
and
that
record
was
created.

If
we
can
get
back
to
the
original
source
data,
if
we
can
get
back
to
inventory
information
and
the
like,
with
a
paper
document
if
you
need
it
or
a
paper
description
of
how
the
final
61
transaction
was
generated,
that
satisfies
all
of
EPA's
criteria
here.
The
rest
of
the
criteria
for
the
maintenance,
for
the
long­
term
longevity
of
all
the
other
electronic
records
the
company
maintains
is
beside
the
point.

I'll
offer
that
as
a
suggestion
to
at
least
analyze
this
framework.
At
least
subdivide
these
into
the
two
questions.

One,
validity
of
the
final
transaction
submitted
to
EPA
and
being
able
to
safeguard
that
through
estoppel,
and
the
second,

how
do
we
maintain
an
adequate
audit
mechanism,
whether
it's
automated
or
not,
to
verify
the
creation
of
that
final
electronic
transaction.
Thank
you.

Howard
Krueger:
I
just
wanted
to
briefly
input
on
the
concept
of
EPA's
allowing
each
program
office
to
decide
whether
they
want
to
opt
into
CROMERRR
or
opt
out.
The
caution
that
I'd
like
to
put
forth
is
that
a
given
point
of
data
or
electronic
capture
of
information
does
not
necessarily
go
to
only
one
program
office.
So
it
would
be
an
absolute
horror
story
if
one
program
office
took
one
position
and
data
that
would
be
reported
to
that
given
program
office
was
also
needed
for
a
compliance
record
in
another
program
office,
which
took
a
direct
opposite
point
of
view
regarding
CROMERRR.
That
is
advanced
water
torture
and
certainly
nobody
wants
that.

Mark
Duvall:
The
purpose
of
today's
meeting
is
to
come
up
with
good
ideas
to
help
EPA
achieve
what
it
needs
to
achieve.
62
One
of
the
difficulties
that
we're
having
is
that
what's
in
the
Federal
Register
is
so
broad.
It
applies
to
all
EPA
programs,

all
EPA
records,
one
size
fits
all.
Obviously,
there
are
many
areas
where
the
CROMERRR
requirements
don't
fit
well.

It
would
be
very
helpful
for
us
to
help
you
if
we
had
a
better
sense
of
what
you
need
to
accomplish.
Following
up
on
what
Mark
Greenwood
suggested,
there
are
at
least
two
different
things
that
you're
trying
to
accomplish
it
strikes
me.
The
first
thing
that
you're
trying
to
accomplish
is
under
the
Government
Paperwork
Elimination
Act
to
fulfill
the
obligation
to
make
electronic
record­
keeping
an
option,
to
remove
obstacles.
There
are
certain
things
that
EPA
has
to
do
that
the
rest
of
us
don't
have
to
do
in
order
to
achieve
that.

Since
most
EPA
record­
keeping
requirements
are
media­
neutral
or
at
least
have
no
obvious
reason
why
records
could
not
be
kept
electronically,
what
EPA
needs
to
do
is
to
draft
a
provision,

which
addresses
the
very
limited
number
of
circumstances
where
existing
record­
keeping
requirements
do
have
an
impediment.

Primarily,
they
would
be
ones
which
have
wording
that
talks
about
paper
or
that
involve
a
handwritten
signature.

I
would
suggest
that
this
could
be
handled
through
two
mechanisms.
First,
to
have
a
general
statement
in
Part
Three
that
says
wherever
any
record
requirement
in
40
CFR
refers
to
paper,
it
is
hereby
deemed
to
also
allow
electronic
record­
63
keeping.
Secondly,
by
having
an
electronic
signatures
piece,

which
is
in
the
proposal,
that
says
essentially
whenever
a
40
CFR
requirement
talks
about
a
handwritten
signature,
that
can
be
satisfied
by
an
electronic
signature
if
the
following
twelve
things
happen.
I
would
suggest
that
those
are
both
actions
that
EPA
can
do
independent
of
what
industry
has
in
the
way
of
its
systems
or
doesn't
have
in
the
way
of
its
systems.

The
second
goal
that
EPA
has,
which
is
quite
apart
and
distinct
from
the
goals
of
the
Government
Paperwork
Elimination
Act,
is
prevention
of
fraud
in
electronic
records.
There
are
many
kinds
of
electronic
records,
many
different
circumstances
under
which
electronic
records
are
kept,
and
any
particular
kind
of
anti­
fraud
provisions
that
would
work
well
perhaps
in
one
context
might
well
not
work
well
in
another
context,
and
certainly
seem
not
to
be
appropriate
for
application
across
the
board.

It
would
be
very
helpful
if
EPA
could
put
into
the
record
an
explanation
of
where
it
perceives
the
fraud
problems
to
be
occurring.
If
we've
established
so
far
that
electronic
recordkeeping
is
commonplace
today
and
has
been
for
a
number
of
years,
then
presumably
EPA
has
gathered
experience
with
fraud
in
electronic
record­
keeping
through
enforcement
activity.

Certainly
we
are
aware
that
there
have
been
fraud
cases
brought.
My
understanding
is
that
to
the
extent
EPA
is
aware
64
of
fraud
in
connection
with
record­
keeping,
it
is
primarily
in
the
laboratory
context,
particularly
environmental
analytical
laboratories.
In
contrast
to
that,
I'm
not
aware
that
there's
been
fraud
in
connection
with
electronic
record­
keeping
in
areas
such
as
discharge
monitoring,
air
emissions
monitoring,

[
Toxic
Release
Inventory]
reporting,
etc.

If
the
need
for
anti­
fraud
provisions
can
be
identified
as
being
most
applicable
to
a
particular
program
area
or
a
particular
context,
then
it
may
well
be
that
you
can
or
we
can
suggest
mechanisms
that
address
that
need.
But
in
the
absence
of
a
context,
when
we're
stuck
with
a
 
I
won't
say
one
size
fits
all,
but
when
we're
stuck
with
all
record­
keeping
requirements
under
40
CFR,
we
can't
even
count
them,
much
less
address
each
different
circumstance.

So
it
strikes
me
that
the
agency
can
help
everybody
reach
a
solution
to
determine
what
mechanisms
are
appropriate
to
deter
fraud,
to
detect
fraud
in
electronic
record­
keeping
by
identifying
where
the
problems
are
occurring
and
what
kinds
of
deficiencies
have
been
identified.
For
example,
if
laboratory
fraud
is
occurring,
is
it
because
of
electronic
records
that
are
being
manipulated
electronically
or
is
it
because
samples
have
been
tampered
with
so
that
the
subsequent
electronic
records
that
are
created
are
faithful
representations
of
electronic
analysis
of
tampered
samples?
If
the
latter,
then
65
electronic
record­
keeping
anti­
fraud
provisions
would
be
irrelevant
to
addressing
that
kind
of
fraud.
In
fact,
my
understanding
is
that
certainly
the
bulk
of
such
fraud
as
is
found
in
the
laboratory
context
has
to
do
with
manual
operations,
such
as
preparation
of
samples,
rather
than
with
someone
going
into
a
computer
file
and
changing
numbers.
It
might
exist
in
theory,
it
might
happen
occasionally
in
practice,
but
if
the
bulk
of
the
problem
is
manual
then
CROMERRR­
type
anti­
fraud
provisions
would
not
be
appropriate.

Until
we
know
what
the
context
is,
we
can't
give
you
good
suggestions
on
how
to
design
a
CROMERRR
program.

Kathy
Barrowclough:
This
is
just
specifically
to
your
points
under
the
criteria
for
electronic
record
retention
systems.
Number
two,
which
says
"
maintain
electronic
records
without
alteration
for
required
retention
period,"
seems
to
totally
contradict
number
six,
which
says
that
you
can
have
an
audit
trail
because
that
indicates
that
you're
going
to
have
changes
to
these
electronic
records.
I
just
quite
frankly
don't
understand
why
you'd
have
a
requirement
that
says
don't
change
this
record,
and
then
you
say
but
have
an
audit
trail
whenever
you
change
it.

Pat
McConnell:
Just
offer
up
as
a
suggestion,
the
criteria
for
the
e­
record
retention
systems
seems
to
have
been
written
or
built
upon
the
current
paper
record
systems.
One
66
suggestion
would
be
that
allow
each
program
office
to
set
a
different
retention
period
for
electronic
records
versus
what
is
currently
in
practice
today
for
paper
records.
Based
on
what
the
gentleman
from
the
electronic
notebooks
said
that
the
system
you
buy
tomorrow
was
obsolete
yesterday,
would
allow
us
to
better
manage
that.
The
audits
on
the
actual
original
electronic
records
can
only
go
back
X
amount
of
time.

Austin
Perez:
I
guess
I've
been
thinking
as
people
have
been
speaking
about
an
alternative.
I
guess
I
want
to
lay
out
the
alternative
and
the
reasoning
behind
it.
I
know
I'm
skipping
ahead
a
little
bit,
please
bear
with
me.
I
guess
I'd
like
to
get
your
initial
reactions
to
this
option.

Suppose
for
a
moment
that
there
are
program
offices
today,

prior
to
CROMERRR,
that
are
currently
allowing
electronic
record­
keeping.
So
that
means
that
they
must
have
taken
the
legal
steps
necessary
in
order
to
make
that
legal.
Whatever
that
may
be,
whether
that's
guidance,
law,
however
they're
doing
it.

I
guess
the
question
is,
or
at
least
one
option
would
be
in
these
circumstances
where
these
folks
have
already
turned
on
the
electronic
record­
keeping,
why
would
they
have
to
do
anything
at
all
under
CROMERRR?
I
suppose
that
there
would
be
a
situation
or
there
could
be
situations
where
there
are,
I
guess,
program
offices
where
electronic
record­
keeping
is
not
67
allowed
legally,
there
is
a
legal
barrier
to
it.
In
those
instances
where
there's
a
legal
barrier,
those
program
offices
could
opt
into
CROMERRR
in
order
to
address
that
legal
barrier.

But
in
those
instances
where
they
don't
see
or
they
have
taken
steps
in
order
to
climb
that
barrier,
I
guess
one
alternative
would
be,
why
do
they
have
to
do
anything
at
all?
When
CROMERRR
goes
into
place
tomorrow,
why
can't
they
just
remain
silent
and
why
couldn't
the
current
program
that
they
have
in
place
remain
in
effect?
I
want
to
lay
out
that
alternative
and
I
guess
I'd
like
to
get
your
initial
reactions.

Robin
Roberts:
If
possible,
as
you
pointed
out,
there
is
a
point
on
the
agenda
dedicated
specifically
to
alternatives
to
e­
records.
If
the
panelists
would
care
to
respond
to
the
question
now
that's
great,
but
I
would
just
like
to
have
that
question
out
there
for
everyone's
consideration
and
we
can
come
back
to
it,
perhaps
as
the
lead
question
when
we
get
to
that
section
on
the
agenda.
Because
we
are
at
lunch
and
I
never
like
to
get
between
people
and
their
lunch.

[
Lunch
break]

Robin
Roberts:
...
your
agendas,
you'll
see
that
the
discussion
we
began
before
lunch
we
were
just
going
to
continue
after
lunch.
Before
we
do
that,
David
just
had
a
few
words
he
wanted
to
say
in
response
to
some
of
the
comments
he
heard
earlier.
68
David
Schwarz:
Mark
Duvall
asked
me
if
we
could
give
some
examples
of
fraud­
related
concerns
that
might
provide
a
context.
I
don't
want
to
do
this
in
a
sense
that
would
be
interpreted
as
at
all
global.
We
don't
have
our
enforcement
people
here
today
and
I
don't
want
to
speak
on
their
behalf.

But
I
thought
I'd
give
you
an
example
anyway
which
I
think
is
pretty
straightforward
and
might
sort
of
help
frame
the
problem,
or
at
least
a
problem
in
some
cases.
It's
actually
an
example
from
the
world
of
paper,
but
I
think
that
when
I
give
it
to
you
you'll
see
what
we're
looking
for
as
an
electronic
counterpart.

There
have,
as
I
understand
it,
been
a
number
of
fraud
cases
involved
with
laboratories
that
have
been
prosecuted
over
the
last
ten
years
or
so.
In
conjunction
with
those,
in
at
least
once
case,
maybe
more,
as
a
part
of
discovery
the
enforcement
people
were
very
glad
to
get
their
hands
on
the
lab
notes
that
recorded
original
observations.
One
of
the
things
that
was
really
interesting
to
them
is
that
in
at
least
one
case
the
lab
notes
had
whiteout
and
then
writ[
ing]
over
on
top
of
[
the]
whiteout
for
some
of
the
values
noted.
Of
course,

that
raised
a
red
flag.
It
doesn't
automatically
mean
that
this
is
fraud,
but
it
certainly
raised
the
question
of
clearly
these
were
changed.
That
helped
them
with
the
investigation.

If
you
think
about
the
transfer
of
that
to
the
electronic
69
environment,
I
think
one
of
the
problems,
or
one
of
the
goals
that
is
sometimes
set
for
us
is
that
we
would
like
to
make
sure
that
the
electronic
system
provides
something
that
corresponds
to
the
whiteout,
that
provides
a
corresponding
forensic
 
we're
not
going
to
have
whiteout
clearly,
but
on
paper
it
is
very
often,
not
always
but
sometimes
or
often,
possible
to
determine
that
things
have
been
changed.
There's
all
sorts
of
rules
about
how
you
keep
a
lab
notebook
and
you
can
sometimes
tell
if
those
have
been
violated.

So
again,
I
think
that
one
of
the
things
we're
looking
for,
and
I
don't
know
whether
we've
gotten
there
or
not,
but
one
of
the
things
that
we're
looking
for
is
a
way
to
give
us
the
corresponding
information
in
the
electronic
environment.

We'd
like
to
see
the
electronic
whiteout
or
something
like
that
that
would
give
us
a
forensic
where
we
need
it,
where
in
fact
there
is
a
question
of
fraud
that
has
to
be
pursued.
So
that's
one
example,
it's
clearly
not
the
only
kind
of
case,
it's
not
the
only
kind
of
concern.
But
I
throw
that
out
for
your
consideration
and
if
people
have
ideas
about
ways
that
we
could
solve
that
problem
we'd
be
very
interested
in
hearing
that.

Mark
Duvall:
The
laboratory
example
is
also
the
example
that
comes
to
my
mind.
I
think
there
are
a
number
of
tools
already
in
place
that
do
address
that.
They're
mainly
in
the
good
laboratory
practice
requirements.
Obviously
not
all
lab
70
studies
are
done
under
[
Good
Laboratory
Practices],
but
the
point
is
that
EPA
in
addressing
laboratory
fraud
has
already
addressed
it.
There
are
a
number
of
provisions
in
place
to
require
reliability
of
records.
For
example,
there
is
an
audit
trail
requirement
in
the
[
Good
Laboratory
Practices]

requirements,
Section
130(
e).
There's
a
requirement
that
electronic
equipment,
like
other
equipment,
be
calibrated
and
be
appropriate,
and
the
[
Good
Laboratory
Practices]
enforcement
people
have
interpreted
that
equipment
calibration
requirement
very
aggressively
to
require
certain
steps
to
be
taken.

So
there
are
a
number
of
ways
to
assure
quality,
to
assure
reliability
in
the
laboratory
context.
Another
example,
not
limited
to
the
[
Good
Laboratory
Practices]
context,
is
EPA
methods,
where
typically
EPA
methods
have
a
number
of
steps
in
there
that
are
designed
specifically
to
address
reliability
of
the
results.

So
to
the
extent
that
laboratories
are
the
main
issue,

it's
helpful
to
deal
with
it
in
those
terms,
because
there
are
a
number
of
laboratory­
specific
approaches
which
have
been
implemented
and
conceivably
could
additionally
be
implemented
that
would
be
appropriate
for
laboratories
but
which
might
not
be
appropriate
for
other
contexts.
One
example
of
a
point
that
EPA
has
proposed
is
an
amendment
to
the
good
laboratory
practice
regulations
that
would
talk
about
the
need
for
71
security
provisions
that
would
be
applicable
to
electronic
as
well
as
paper
records.

It's
interesting
that
in
that
proposed
rule,
which
I
understand
is
sort
of
hanging
fire
because
CROMERRR
came
along,

in
that
proposed
rule
EPA
considered
it
to
be
sufficient
to
have
a
provision
that
said
security
provisions,
without
detailing
what
those
security
provisions
might
be.
They
didn't
say
audit
trail
and
preservation
of
records
and
this
and
that,

they
made
it
a
performance
standard
to
require
 
and
again,

this
is
just
a
proposed
rule
 
but
to
do
what
was
appropriate
under
the
circumstances.

That
might
be
an
approach
that
EPA
could
consider,
a
performance
standard
that
says
under
these
circumstances
do
what
is
appropriate
and
we
can
give
you
some
suggestions.
But
not
require
specific
things
in
all
program
areas
which
might
well
not
be
appropriate.

Mark
Greenwood:
On
the
fraud
issue,
I
think
it's
useful
to,
since
we're
kind
of
on
this
topic,
to
ask
you
to
also
think
more
broadly
about
the
set
of
factors
that
you
should
think
about
that
go
beyond
the
one
that
you
were
just
describing.

The
electronic
audit
trail
concept
and
how
that
fits
in
with
a
whole
set
of
factors
that
frankly
push
back
against
the
likelihood
of
fraud.
In
other
words,
I
think
there's
some
other
things
to
think
about.
72
Mark
was
alluding
to
the
fact
that
if
you're
going
to
commit
fraud
in
the
entry
of
data,
audit
trails
don't
help
you.

But
there
are
several
other
factors
as
well.
In
some
ways,

what
we
have
today
as
we
look
towards
moving
with
electronic
sensors
and
monitors
that
are
connected
directly
to
the
electronic
data
systems,
frankly
you
are
reducing
the
probability
that
humans
are
going
to
get
in
there
and
change
the
data.
I
would
submit
that
the
trend
we're
on
with
electronic
reporting
and
record­
keeping
is
anti­
fraud
in
many
ways.

Another
factor
to
consider
is,
for
many
of
the
records
we're
talking
about
here,
they
are
also
business
records.
So
for
example,
a
[
Toxic
Substance
Control
Act]
requirement
may
need
to
know
the
production
data
you
have.
There
are
all
number
of
reasons
why
you're
not
going
to
go
falsify
your
production
information.
That's
fairly
useful
business
information.
That
pushes
far
against
anything
you
do
for
an
EPA
requirement.

Then
I
think
institutionally,
[
inaudible]
recognize
that
falsification
of
information,
depending
on
the
context,
can
be
a
criminal
act.
I
would
not
minimize
to
any
great
degree
how
significant
that
is
in
the
minds
of
an
employee
of
a
company.

The
electronic
media
reinforces
that
in
the
following
sense.

Electronic
systems
tend
to
facilitate
the
sharing
of
data,
so
73
if
a
bunch
of
people
have
access
to
data
and
you
want
to
falsify
something,
you
suddenly
have
to
sort
of
muster
a
conspiracy
of
people
to
try
to
make
sure
that
that
data
is
changed
and
it
stays
that
way
to
actually
make
this
come
off.

That's
highly
improbable
in
the
world
in
which
we
work
today.
So
I
think
there
is
a
set
of
these
factors
that
need
to
be
weighed
and
looked
at
as
you
look
at
the
overall
question
of
fraud.

Bruce
Adler:
I
want
to
just
add
to
what
the
two
Marks
have
just
said.
That
is,
if
you
step
back
a
little
bit
and
think,
let's
use
air
monitoring
as
a
particular
example.
If
you've
got
an
air
monitor
with
a
readout
and
somebody,
a
worker,
an
employee,
goes
over
and
takes
the
reading
off
of
that
air
monitor,
writes
it
down,
and
you
compare
that
to
a
continuous
emissions
monitor
which
feeds
it
directly
into
a
tracking
system,
the
latter
program
of
the
electronic
recordkeeping
is
much
less
likely
to
be
susceptible
to
fraud
than
the
transcribing.
If
you're
looking
at
decreasing
the
likelihood
of
fraud,
you
do
that
by
encouraging
electronic
record­
keeping.

You
don't
have
to
get
into
the
audit
trail
picture.
It's
not
relevant.

If
your
objective
is
to
reduce
the
likelihood
of
fraud,

using
and
making
it
easy
to
use
electronic
record­
keeping
accomplishes
that
objective.
But
if
you're
trying
to
add
more
74
onto
it
by
let's
say
making
fraud
impossible,
then
you
set
an
unreasonable
goal
for
yourselves
and
you're
going
to
create
an
unworkable
system.
So
I
really
encourage
you
to
step
back
and
say,
is
this
system,
is
an
electronic
system
less
susceptible
to
fraud
than
a
handwritten
system,
a
paper
record
system.
If
the
answer
is
yes,
then
you've
achieved
your
objective.

Carolyn
Greenwood:
Carolyn
Greenwood,
I'm
from
Environmental
Systems
Corporation.
No
relation
to
Mark
Greenwood
that
I
know
of.
We
are
a
data
systems
vendor,
which
sounds
like
a
dirty
word
in
this
room,
if
I
remember
earlier.

We
do
not
require
upgrades
on
purpose.
But
my
real
point,
what
I
wanted
to
say
is,
we
do
mostly
air
monitoring
applications,

almost
exclusively.
We
have
a
lot
of
utilities
that
are
our
customers
and
a
number
of
state
agencies.
Most
state
air
pollution
agencies
use
our
software.

I
just
want
to
say,
adding
an
audit
trail
can
be
quite
expensive.
It's
not
a
simple
thing
for
us
to
do.
We
have
done
that
to
our
programs,
most
of
our
programs
have
them.
But
I
can't
speak
for
the
other
media,
the
other
vendors.
I
don't
know
if
they
would
have
them.
I'm
guessing
a
number
of
people
would
need
to
have
their
software
changed
to
add
an
audit
trail
and
that's
not
a
trivial
thing.
So
keep
that
in
mind
as
you're
considering
that.

Robin
Roberts:
Any
more
questions
on
general
criteria
of
75
the
rule
and
technical
aspects
of
implementing
it,
problems?

Seeing
no
hands
raised,
one
last
hand
and
then
we'll
move
on.

Unidentified
Male
Speaker:
I'll
just
make
a
comment
to
follow
up
what
this
young
lady
said.
One
of
the
things
that
has
been
pointed
out
to
me
by
the
[
information
technology]

people
at
my
company
is
that
yes,
we
buy
standard
packaged
software
from
vendors.
But
regrettably,
we
don't
implement
it
in
a
standard
way.
We
customize
everything.
One
of
the
things
I've
learned
from
talking
with
many
of
my
colleagues
is,
I
won't
say
everyone,
but
the
large
majority
of
companies
customize
these
standard
packages.
So
that
even
if
you
create
a
solution
to
the
off­
the­
shelf
product
that
you
buy,
you
still
have
to
generate
hundreds
of
different
implementation
scenarios
for
that
one
package
that
you
buy.

Charles
Reese:
One
thing
we
haven't
touched
on
today
is
how
to
deal
with
electronic
records
in,
say,
a
sponsor­
contract
facility
relationship.
This
creates
a
very
difficult
problem
for
us,
if
a
sponsor
company
were
to
go
and
hire
a
contract
facility
and
that
facility
has
electronic
record­
keeping
systems.
Those
systems
may
have
some
sort
of
compatibility
or
no
compatibility
whatsoever
with
the
sponsor
systems.

Now
we
purchase
work,
the
work
is
done,
completed.
At
that
point,
how
do
we
address
maintaining
electronic
records
that
we
may
have
no
way
to
read
or
no
way
to
handle
because
76
they
were
generated
on
a
completely
alien
system
to
us?
Is
it
going
to
be
the
contract
facility's
responsibility
to
maintain
that
electronic
record
for
the
life?
Or
are
they
going
to
charge
us
to
maintain
that
system?
Are
they
going
to
transfer
it
to
us
like
they
do
the
paper
records
now
and
say,
you
paid
us
your
money,
we
did
the
work,
we're
done,
now
it's
your
responsibility.
If
that's
the
case,
we
could
end
up
with
a
giant
set
of
files
that
we
literally
can
do
nothing
with
but
maybe
maintain.

So
what
do
we
do
in
those
situations?
How
we
handle
this
contract
situation
is
going
to
be
a
very
big
question
for
any
kind
of
managing
electronic
records.
This
relationship
goes
on
with
any
company
out
there
who
outsources
any
kind
of
work.

Those
are
big
general
criteria
to
think
about.

Kathy
Barrowclough:
While
we've
talked
about
this
and
sort
of
touched
on
it
with
several
of
the
different
comments
made,
I
don't
think
we've
really
identified
the
considerable
issue
with
the
idea
of
legacy
systems.
It
was
sort
of
touched
on
by
the
vendor
there
in
saying
how
difficult
it
is
to
add
an
audit
trail,
but
in
essence
once
CROMERRR
is
implemented
companies
would
be
obligated
to
review
all
of
their
existing
systems
to
see
whether
or
not
they
meet
the
CROMERRR
criteria,

in
order
to
ensure
that
they
do
meet
those
criteria.

The
cost
of
doing
that
is
really
great.
First
you've
got
77
to
inventory
all
of
your
systems,
look
at
each
of
those
systems
and
see
whether
or
not
it
has
audit
trail
capability
or
function,
whether
it
has
all
of
these
security
features
that
the
nine
points
raise
in
the
record­
keeping
part.
Then
you
have
to
get
a
plan
in
place
for
what
you
are
going
to
do
with
that,
so
that
when
the
enforcement
arm
does
come
around
you
can
say
what's
happening.
There's
a
considerable
cost
and
resource
drain
in
order
to
do
that
for
all
of
those
legacy
systems.

Robin
Roberts:
Any
last
questions?
Thank
you
for
your
comments
on
that.
Before
we
move
on
to
the
alternative
approaches,
to
e­
records
standards,
David
had
a
word
he
wanted
to
say.
Then
also
the
audience,
Ms.
Roberts
here
would
have
something
to
say
after
David's
comments.

David
Schwarz:
Just
as
we
begin
to
talk
about
alternatives
to
the
current
proposal,
I
just
think
it's
important
to
remind
ourselves
that
the
rule­
making
process
is
an
agency­
wide
process.
The
decision
as
to
what
we
actually
come
up
with
as
a
final
rule
is
not
just
up
to
the
people
who
are
seated
here.

So
I
know
in
some
cases
it
may
be
disappointing
or
frustrating
that
you
give
us
this
great
alternatives,
we
don't
just
nod
our
heads
in
unison
and
say
oh
yes,
we'll
do
that.

But
we
can't
say
that,
because
we
really
 
what
we
can
do
as
appropriate
is
we
can
give
you
feedback
in
terms
of
what
we
78
might
think
of
it
individually
in
some
cases.
But
the
truth
is,
for
all
the
ideas
that
we
hear
today,
we'll
be
willing
to
take
them
back
to
our
colleagues
at
the
agency,
to
the
workgroup,
and
consider
them
together.

So
I
just
don't
want
people
to
feel
that
because
we're
not
going
to
give
you,
say
yea
or
nay,
as
you
make
suggestions,

we're
certainly
going
to
consider
them,
and
we're
very
grateful
to
have
your
thoughts.
You
will
see
us
respond
to
them
but
the
response
may
not
become
apparent
until
the
final
rule
is
published
or
until
some
notice
is
published
that
indicates
an
action.
So
I
just
want
people
to
be
clear
about
that.

Robin
Roberts:
We
had
a
question
before
we
broke
that
anticipated
this
discussion.
That
gentleman
has
left
the
room
but
Ms.
Roberts
is
going
to
tell
us
about
it.

Kathleen
Roberts:
Remind
me
to
thank
Austin
for
posing
this
question
and
then
leaving.
As
I
recall,
the
question
was,

if
there
were
some
programs
that
had
already
legally
implemented
the
ability
for
companies
to
use
electronic
recordkeeping
I
guess
essentially
would
those
be
grandfathered
in
under
CROMERRR.
Would
CROMERRR
have
to
apply
to
those
programs
or
could
they
forever
opt
out
of
CROMERRR?
If
I
restated
the
question
incorrectly,
certainly
someone
let
Robin
know.

Jamie
Conrad:
Jamie
Conrad
with
the
American
Chemistry
Council.
He
talked
a
little
bit
about
it.
What
he
was
79
suggesting
was
since
it
appears
as
though
in
virtually
 
it
seems
to
be
hard
for
any
of
us
to
come
up
with
an
example
where
existing
EPA
regulations
would
seem
to
prevent
electronic
record­
keeping,
then
why
not
just
state
that
all
current
forms
of
electronic
record­
keeping
are
okay.
And
if
there
are
any
that
anybody's
aware
of
out
there,
any
instances
where
people
are
keeping
paper
records
and
wish
they
could
go
electronically,
those
people
could
opt
into
CROMERRR.
But
it
would
only
exist
as
an
option
for
those
people
that
wanted
to
pursue
it,
and
that
otherwise
electronic
record­
keeping
could
be
sort
of
authorized
kind
of
by
fiat,
the
way
it
is
now.

Unidentified
Male
Speaker:
The
response
is
we
could
do
that.
I
think
that's
an
option
that
we're
prepared
to
consider.

Howard
Krueger:
A
caution
on
the
issue
of
grandfathering
is
if
you
grandfather
everything
that
you're
doing
now
and
say
we're
only
going
to
do
things
in
the
future,
based
on
the
profile
of
burgeoning
regulation
in
the
past
ten
years
and
even
more
in
the
last
five
years,
it
certainly
isn't
going
down.

That
will
still
place
a
huge
burden
for
all
new,
yet
to
be
defined,
regulations.
So
that's
one
caution.

But
even
more
importantly
I
think
is,
if
you
were
to
grandfather
existing
systems,
then
what
about
eighteen
months
later
when
there
is
an
upgrade
to
an
existing
system,
so
you
80
now
have
a
new
system.
Suddenly,
your
current
way
of
doing
records,
which
was
nicely
grandfathered,
no
longer
maintains
that
shield
and
protection
because
of
the
new
system
that
came
in.

As
we
all
know,
technology,
there's
some
rule
that
every
eighteen
months
everything
is
changed.
So
the
grandfathering
is
only
good
for
eighteen
months,
and
then
suddenly
it's
back
to
ground
zero
again.
So
I
am
very
hesitant
about
thinking
 
let's
say
I
don't
understand
how
grandfathering
would
work.
If
there
is
some
creative
solution
that
would
be
wonderful,
but
I
just
don't
understand
how
that
could
work.

Mark
Duvall:
Thinking
about
alternatives
to
CROMERRR
as
it's
structured
now,
it
strikes
me
that
 
[
End
of
Tape
2,
Side
A;
Side
B
begins]

­­
need
to
be
addressed,
because
timing
is
very
important
here,
as
we
decide
what
needs
to
be
addressed
now,
what
can
be
addressed
later.
The
one
pressing
time­
driven
provision
is
that
of
the
Government
Paperwork
Elimination
Act.
That
requires
EPA
to
make
electronic
record­
keeping
available
as
an
option
by
October
2003.
That
piece
of
rule­
making
 
Unidentified
Speaker:
Reporting.

Mark
Duvall:
Both
of
them.
Both
options,
both
reporting
and
signatures
and
record­
keeping
need
to
be
made
available
by
October
2003
according
to
the
legislation.
So
what
EPA
needs
81
to
do
by
that
time
is
to
the
extent
that
there
are
any
obstacles
to
electronic
record­
keeping,
those
need
to
be
removed
through
rule­
making.
To
me,
the
only
obstacles
that
could
be
available
would
be
those
that
call
for
a
handwritten
signature.
That
can
be
addressed
through
a
fairly
straightforward
prophylactic
electronic
record­
keeping
provision.
That's
the
only
time­
driven
piece.

The
bulk
of
what's
in
the
record­
keeping
provisions
in
CROMERRR
are
not
addressed
to
that
aspect,
but
rather
are
addressed
to
the
anti­
fraud
concerns.
Those
are
appropriate
public
policy
concerns
that
need
to
be
addressed
in
an
appropriate
forum.
Rule­
making
is
an
appropriate
forum.
But
keep
in
mind
that
the
timing
for
those
provisions
is
quite
different
from
the
timing
for
the
[
Government
Paperwork
Elimination
Act]­
driven
provisions.

The
current
CROMERRR
provisions
obviously
are
causing
a
lot
of
consternation.
They
are
probably
not
the
right
approach
for
addressing
the
fraud
provisions,
for
a
couple
of
reasons.

The
main
reason
being
that
they're
not
addressed
to
the
particular
concerns,
the
particular
problems
with
fraud.

[
Office
of
Management
and
Budget],
in
issuing
guidance
to
agencies
under
the
[
Government
Paperwork
Elimination
Act],

urged
agencies
to
conduct
a
risk
assessment,
to
find
out
where
the
concerns
are
with
fraud,
address
the
high,
medium
and
low
82
areas,
and
address
the
security
provisions
according
to
the
results
of
that
risk
assessment.
Most
agencies
have
done
that
and
have
reported
to
[
Office
of
Management
and
Budget]
where
their
biggest
concerns
are.
A
lot
of
times
those
have
had
to
do
with
reporting,
as
opposed
to
record­
keeping,
but
the
same
requirement
applies
to
record­
keeping.

It
strikes
me
that
what
would
be
appropriate
for
EPA
to
do
would
be
to
do
a
risk
assessment,
find
out
the
areas
where
there
is
a
high
concern
with
fraud
in
electronic
recordkeeping
and
devise
proposed
anti­
fraud
provisions
that
would
be
appropriate
for
those
contexts,
one
or
more.
Industry
would
be
glad
to
participate
in
a
focused
discussion
as
to
what
would
be
appropriate
for
particular
contexts.
From
what
we
heard
this
morning,
quite
possibly
the
laboratory
context
might
be
one
such
area.
In
fact,
anti­
fraud
provisions
have
been
a
main
topic
of
discussion
in
connection
with
the
[
Good
Laboratory
Practices]
regulations
ever
since
their
inception,
because
much
of
what
the
[
Good
Laboratory
Practices
regulations]
are
for
is
prevention
of
fraud.

The
timing
on
this
focused
anti­
fraud
discussion
 
there
is
no
particular
time
constraint
to
that.
Accordingly,
it's
appropriate
for
EPA
to
do
the
ground
work
of
the
risk
assessment
that
[
Office
of
Management
and
Budget]
called
for
to
identify
the
high­
priority
areas
and
then
to
contemplate
83
particular,
appropriate,
media­
specific,
context­
specific,

proposed
controls
that
could
then
be
debated
in
an
appropriate
manner.
But
that
would
mean
that
the
record­
keeping
provisions
of
CROMERRR
would
need
to
be
decoupled
from
the
electronic
signatures
and
the
electronic
record­
keeping
provisions.

Otherwise,
that
anti­
fraud
discussion
will
slow
down
the
promulgation
of
the
signatures
and
reporting
provisions,
which
have
the
time
deadline.

So
my
suggestion
as
an
alternative
to
what
has
been
proposed
in
the
Federal
Register
is
to
decouple
them,
have
EPA
do
the
risk
assessment,
draft
appropriate
provisions
and
then
repropose.

Robin
Roberts:
Mark
has
broached
a
subject
that
we
had
discussed
as
something
that
should
be
on
the
agenda.
This
was
the
particular
discussion
where
we
wanted
to
hear
your
thoughts
about
this
notion
of
decoupling
Subpart
C
from
the
rest
of
the
rule.

Henry
Bartholomew:
I
think
to
follow
on
the
comments
that
were
just
offered
and
Mark
Greenwood's
comments
earlier
about
the
hierarchy,
a
unifying
theme
for
how
EPA
might
approach
each
of
these
categories,
the
issue
of
making
electronic
recordkeeping
and
reporting
generally
available
 
a
separate
issue,

is
there
a
problem
with
reliability
and
being
able
to
track
the
reliability
and
fraud
issues.
Third,
the
archiving
and
long­
84
term
retention
issue.
I
agree
to
break
these
up
if
these
are
three
separate
themes.
A
unifying
theme
would
be,
is
anything
broken.

Let's
start
with
the
electronic
record­
keeping
and
reporting.
You're
hearing
from
folks
in
this
room
that
the
vast
majority
of
large
businesses
and
industries
in
this
country
are
using
electronic
record­
keeping
and
to
some
extent
reporting
to
comply
with
EPA
monitoring
and
reporting
requirements.
So
that
suggests
to
me
that
for
the
primary
program
areas
the
EPA
is
involved
in
 
air,
water,
that
I
know
of
for
sure,
and
others,
solid
waste
 
there
may
not
be
a
huge
problem
in
companies
being
able
to
do
it.
Fact
is,
they're
doing
it.
There
may
yet
be,
on
the
other
hand,
some
areas
for
improvement.
It
may
be
that
EPA
can
do
some
things
to
make
reporting
more
easily
available
electronically
than
is
currently
the
case.

My
suggestion
would
be,
if
you
want
to
step
back
and
take
a
fresh
look
at
this
in
light
of
all
the
negative
feedback
you're
getting
on
what's
been
proposed,
put
out
a
notice
of
inquiry
on
the
electronic
record­
keeping
and
reporting
issue
and
say,
are
there
areas
where
you,
industry,
are
having
problems
being
able
to
do
this
under
EPA's
current
regulations,

the
statutes
and
our
guidelines
and
policies.
See
what
feedback
you
get.
85
The
answer
may
be,
not
very
many,
and
it
goes
to
the
point
just
raised.
What
you
need
to
do
by
October
2003,
presumably,

is
help
to
address
those
specific
issues.
So
focus
on
that.

You
may
find
that
there's
not
a
lot
that
needs
fixing
and
you
may
not
need
this
sort
of
global
approach
to
fix
those
sorts
of
problems.
So
that
would
be
a
recommendation.

Then
if
you
want
to
step
to
the
fraud
issue,
same
question.
There
I
think
the
experience
of
your
enforcement
staff
is
pertinent.
The
question
again
is,
are
you
finding
things
are
broken.

I
liked
the
suggestion
that
came
up
sort
of
tangentially
earlier,
of
require
people
to
document
the
system
that
they've
got
in
use
from
1995
to
1999
before
they
adopt
a
new
system
and
what
the
[
inaudible]
of
reliability
of
that
system
are.
Keep
that
so
that
if
a
question
later
arises
within
an
enforcement
or
audit
timeframe
they
have
that
as
the
[
inaudible]
of
reliability
as
to
the
information
that
was
provided
to
EPA.

Don't
necessarily
require
them
to
track
through
an
auditable
signature
hand­
off
approach
every
data
element
that
comes
out
of
an
automatic
monitoring
system
and
is
handled
by
multiple
computers
and
software
processes
and
so
forth,
ad
infinitum,

with
the
costs
that
you're
hearing
about.
Make
them
document
what
the
system
is
and
provide
that
as
the
[
inaudible]
of
reliability.
So
a
couple
of
thoughts.
86
Maria
Angelo:
DuPont
supports
the
proposal
to
decouple
the
reporting
and
e­
signature
from
the
record­
keeping,
and
very
strongly
supports
the
concept
of
the
risk
evaluation
assessment
and
setting
priorities
around
the
anti­
fraud.
However,
that's
not
to
say
that
we
support
the
proposed
rule
with
respect
to
the
reporting
and
e­
signatures.
We
have
some
specific
concerns
around
why
the
proposal
goes
farther,
in
our
mind,
than
the
esign
legislation
and
the
reporting
rules
itself
with
respect
to
registration
for
submitting
reports
electronically,
the
concept
of
validation
and
the
number
of
registrants
per
facility,

delegation
of
authority,
those
sorts
of
things.
So
I
think
that
part
of
the
rule,
while
it
may
be
able
to
be
decoupled,
I
think
still
has
some
opportunities
to
make
it
a
little
bit
more
workable.

Jim
Scialabba:
In
line
with
some
of
the
comments
that
have
come
out
about
the
decoupling,
as
regards
the
recordkeeping
something
that
the
EPA
has
done
in
other
programmatic
areas
to
improve
the
workability
of
regulations
has
been
to
move
more
to
performance
standards
and
away
from
prescription.

I
believe
that
that's
one
of
the
problems
that
we're
all
tripping
over
in
our
review
of
the
record­
keeping
requirements
here
is
that
it's
too
prescriptive.
One
thing
about
prescription,
and
particularly
as
relates
to
information
technologies,
is
too
much
prescription
inhibits
innovation.
I
87
think
as
the
regulations
are
currently
written,
that
it
would
inhibit
the
kind
of
innovation
you
all
would
be
looking
for
that
would
improve
reliability,
and
for
us
in
the
regulated
community
would
find
opportunities
to
reduce
the
cost
and
the
burden,
yet
improve
our
compliance
profile.

With
all
that
said,
a
for
instance
of
what
the
EPA
has
done
that
we
have
found
beneficial
is
encouraging
companies
to
implement
environmental
management
systems,
because
it's
the
linkage
between
all
of
the
activities
in
organizations
that
aren't
put
in
place
or
aren't
efficient
that
have
been
found
to
be
inhibitive
to
improved
compliance.

So
I
believe
the
record­
keeping
requirement,
if
it
would
step
back
from
 
be
less
prescriptive
and
more
encouraging,

performance
standard­
based
around
a
record­
keeping
management
system,
that
it
would
be
more
palatable.
Industries
or
companies
would
find
ways
to
comply
with
a
performance
standard
that
should
satisfy
a
lot
of
the
record­
keeping
requirements
that
the
EPA
rightly
should
require
for
validation,
for
information
that's
turned
over
to
the
agency.

Frank
Miller:
In
the
spirit
of
brainstorming,
again
just
share
some
ideas
about
alternative
approaches.
Some
other
things
that
maybe
you
could
focus
on
in
the
spirit
of
e­
records
is
sort
of
around
transaction
standards,
that
area,
making
it
easier
to
conduct
the
business
of
reporting.
Focus
on
the
88
standardization
of
the
various
government
or
agency
systems
that
we
have
to
report
to,
to
again
help
minimize
the
effort
to
do
reporting.
It's
been
said
a
couple
times
already,
around
either
performance­
oriented
standards
or
guidance
or
perhaps
even
phased­
in
standards
from
sort
of
what's
minimal
or
what's
reasonably
achievable
in
today's
environment
with
an
eye
towards
maximum
or
highly
disciplined
approach
to
this,
giving
software
vendors
or
our
staffs
time
to
figure
out
innovative
ways
to
close
those
gaps.

I've
heard
a
lot
of
good
things
today
in
terms
of
record
creation,
analysis,
data
capture.
It's
very
prevalent
and
it's
a
smart
way
to
do
things.
Is
there
anything
that
we
can
do
in
terms
of
moving
forward
in
some
sort
of
partnership
way,
beyond
just
sort
of
this
commenting
approach
to
the
rule?
Is
there
any
better
way
for
us
to
collaborate
together
on
achieving
this?

I
guess
lastly,
perhaps
we
could
have
an
alternative
goal,

or
an
additional
goal,
and
maybe
that
goal
could
be
drive
toward
minimizing
the
effort
to
report
compliance
and
to
receive
what
we're
reporting,
such
that
we
both
and
we
all
benefit
from
that,
so
that
we
can
focus
more
on
the
source
reduction,
the
sustainability
and
so
on.
If
we
can
take
the
cost
and
the
effort
down
there,
that
can
serve
a
greater
purpose.
So
in
the
spirit
of
brainstorming,
those
are
some
89
ideas.

Mike
Penders:
Mike
Penders,
Environmental
Protection
International.
The
more
I
consider
this,
and
as
you
know
we've
considered
this
together
for
some
time,
the
more
I
really
come
to
the
opinion
that
the
record­
keeping
has
to
be
decoupled
from
the
electronic
reporting
to
facilitate
this.
Otherwise,
you
set
up
a
dichotomy,
just
focused
on
ways
to
minimize
fraud,

where
all
the
potential
for
fraud
currently
exists
with
the
electronic
record­
keeping
that
occurs
now
and
could
continue
as
long
as
someone
prints
it
out
and
submits
it
to
the
agency.

But
you're
setting
up
conditions
for
those
who
would
electronically
report
that
do
not
apply
to
those
who
submit
on
paper
now.
So
first,
it's
not
effective
to
address
fraud.

Secondly,
it
presents
obstacles
to
electronic
reporting,

which
provides
a
whole
range
of
other
benefits
to
the
enforcement
and
compliance
function
and
may
be
even
of
greater
benefit
in
detecting
fraud
in
the
first
instance
by
keeping
the
obstacles
low
to
facilitating
more
electronic
reporting,
which
allows
a
timeframe
of
bringing
information
together
from
other
sources
that
allows
the
government
to
detect
fraud
in
the
first
place.

So
I
think
it's
really
fundamentally
unfair
to
require
companies
as
a
condition
of
electronic
reporting
and
against
the
thrust
of
a
lot
of
the
paperwork
elimination
laws
and
90
policies
and
the
e­
commerce
law
signed
by
President
Clinton,
to
require
a
standard
that's
not
now
required
under
law
or
regulation
of
those
who
rely
on
electronic
reporting,
just
by
virtue
of
the
fact
that
a
company
chooses
to
avail
itself
of
an
electronic
reporting
option.
And
then
address
the
considered
opportunities
for
fraud
and
record­
keeping
requirements
that
may
combat
that,
program
by
program,
where
those
problems
with
fraud
have
manifested
themselves,
such
as
in
the
laboratory
context.

But
taking
part
of
the
criminal
investigations
into
the
laboratory
fraud,
such
as
some
of
the
cases
have
been
publicized,
it
would
have
made
no
difference
to
that
investigation
if
that
had
been
electronically
reported.
In
fact,
it
would
have
provided
greater
opportunities
for
the
government
to
investigate
if
it
had
been
electronically
reported
than
having
to
go
through
all
the
paper
submissions
and
then
compare
that
back
to
the
electronic
record­
keeping
that
was
in
place
and
trying
to
reconcile
that.

So
in
considering
this,
I
really
think
that
it
makes
a
lot
of
sense
to
decouple
and
consider
the
record­
keeping
requirements
in
part
of
other
programs.

Kathleen
Roberts:
On
the
basis
of
what
industry
understands
of
EPA's
concerns
related
specifically
to
fraud
and
archiving
and
the
rule
as
proposed,
[
American
Chemistry
91
Council]
believes
there
are
no
simple
modifications
to
the
proposal
or
the
criteria.
We
don't
see
any
quick
fixes
that
can
go
in.
So
we
also
support
the
suggestion
of
decoupling
the
record­
keeping
from
the
rest
of
the
rule
and
moving
forward.

Notwithstanding
what
might
be
needed
in
order
to
meet
the
deadline
for
the
[
Government
Paperwork
Eliminatoin
Act]

requirements.

Kathy
Barrowclough:
What
I'd
like
to
do
is,
you're
hearing
a
lot
of
let's
decouple
the
record­
keeping
from
the
reporting.
I'd
like
to
go
even
beyond
that,
in
that
our
understanding
is
that
Office
of
Environmental
Information
is
not
the
enforcement
arm,
it's
the
different
programs.
Even
after,
if
indeed
the
decoupling
occurs,
we
believe
that
it
would
be
important
for
EPA
to
set
up
workgroups
of
regulated
industry
as
well
as
internal
program
people
from
the
enforcement
arm,
in
order
to
work
through
what
some
of
those
issues
are
and
come
up
with
an
acceptable
record­
keeping
rule.

Barbara
Foy:
I
just
wanted
to
also
support
the
notion
that's
been
expressed
of
decoupling
the
record­
keeping
portion
of
the
rule
to
allow
for
additional
consideration
of
all
of
the
various
issues
that
have
been
raised
today.
I
think
that
some
of
the
strongest
reasons
for
that
include
the
fact
that
has
been
pointed
out
that
all
records
don't
seem
to
be
created
equal,
the
high
costs
that
have
been
estimated,
to
be
92
associated
with
complying
with
CROMERRR,
and
the
lack
of
technology
available
today
to
meet
some
of
the
requirements
that
are
proposed
by
the
rule.
I've
also
heard
a
number
of
people
express
support
for
an
approach
that
considers
maybe
a
tiered
type
of
approach
to
record­
keeping,
dividing
recordkeeping
into
different
categories
and
maybe
setting
different
criteria
depending
on
the
nature
of
those
records,
and
would
also
want
to
support
some
further
investigation
of
that
kind
of
an
approach.

Mark
Greenwood:
Obviously
you're
hearing
some
fairly
consistent
general
advice
here
from
I
think
everybody,
which
I
certainly
would
support.
The
one
thing
though,
following
on
a
comment
that
was
just
recently
made,
as
you
look
at
some
of
these
requirements
that
you'd
like
to
improve
for
the
future,

let's
talk
about
this
archiving
notion
as
an
example.
It
is
important
for
you,
[
Office
of
Environmental
Information],
not
to
try
to
do
that
yourself.
I'm
sure
you
don't
want
to.
But
you
have
program
offices
who
have
set
these
record­
keeping
time
periods.
These
have
for
the
most
part
never
really
been
carefully
reexamined
after
twenty,
twenty­
five
years
sometimes.

A
very
useful
exercise
is
to
be
going
through
those
individual
record­
keeping
requirements
and
the
timeframes
and
say,
why
are
we
making
people
keep
these
records
so
long,
and
really
examine
the
underlying
policy
reasons
for
doing
that
and
93
try
to
decide
whether
it
makes
any
sense
to
do
today.
So
I
would
urge
you,
as
you
look
at
at
least
that
piece
of
it,
to
really
bring
in
the
other
program
offices
and
have
more
policy
discussion
on
those
questions.

Bill
Barta:
Bill
Barta,
FMC
Corporation.
I
want
to
second
the
proposals
to
separate
record­
keeping
from
reporting.

Obviously,
there
are
many
complex
issues
to
be
discussed
that
are
going
to
take
some
time
to
consider
carefully.
But
I
want
to
also
suggest
that
we
ought
not
to
ignore
the
reporting
side.

There
are
some
significant
problems,
as
I
see
it,
on
that
side.

I
would
hope
there
would
be
some
way
or
forum
or
public
meeting
to
address
those
as
well.

Howard
Krueger:
Likewise
I
support
the
decoupling.
I
was
going
to
make
a
specific
suggestion
that
was
just
made
over
here
about
having
a
meeting
such
as
this
focused
on
the
reporting
and
electronic
signature
side.
I
think
that
some
ideas
might
come
out
of
that
to
provide
the
improvements
that
would
help
the
other
part
of
the
proposal
to
survive
and
to
attain
the
deadline
targets
that
we
all
are
aware
of,
October
of
'
03.
So
again,
I
support
decoupling
and
to
create
a
datagathering
and
corrections­
type
session
on
those
other
two
parts.

Carolyn
Greenwood:
If
you
decouple,
whether
you
decouple
or
not,
one
thing
to
keep
in
mind
is
there
may
be
some
useful
94
corollaries,
I
guess,
to
be
gleaned
from
the
acid
rain
program
as
well
as
ambient
air
quality
reporting
under
their
air
system.
They
both
have,
as
I
understand
it,
after
records
are
submitted
to
EPA
or
to
the
states
for
EPA,
there
are
checks
that
are
done
on
the
data.
There's
a
lot
of
stuff
you
can
do
with
electronically
reported
data
that
you
can't
do
with
paper
very
practically.
So
if
you're
concerned
about
fraud
or
any
kind
of
inaccuracies
in
the
data,
that
electronic
reporting
step
will
get
you
part
of
the
way
there
if
EPA
also
wants
to
take
or
the
states
want
to
take
that
extra
step
of
doing
some
internal
checks.
A
lot
of
that
can
turn
up
errors
that
are
inadvertent
or
otherwise.
So
it
does
accomplish
a
little
bit
of
the
other
goal
as
well
as
getting
at
the
fraud
issue
maybe.

Doug
Billings:
Doug
Billings
from
the
U.
S.
Chamber
of
Commerce.
The
Chamber
also
supports
the
decoupling
proposal,

the
idea.
I
also
want
to
speak
strongly
in
favor
of
what
Mark
Duvall
proposed
in
terms
of
risk
assessment.
One
observation
I
would
make
in
that
regard
is
that
when
this
rule
was
originally
proposed,
because
it
was
presented
as
voluntary
there
weren't
the
various
assessments
that
were
required
under
[
the
Small
Business
Regulatory
Enforcement
Fairness
Act]
and
the
regulatory
impact
analysis
that
needs
to
be
done
under
the
executive
order,
under
unfunded
mandates.

I
would
suggest
that
if
this
thing
is
decoupled
and
the
95
record­
keeping
aspect
is
looked
at
separately,
that
those
analyses
be
done
before
the
rule
is
re­
proposed,
if
it's
reproposed
I
think
that's
a
way
to
get
at
the
risk
assessment
and
various
other
elements,
in
context
with
working
with
industry.
Certainly
the
[
Small
Business
Regulatory
Enforcement
Fairness
Act]
review
panel
would
be
another
way
to
get
industry
input
on
those,
but
I
think
all
of
those
collectively,
if
those
analyses
are
done,
should
lead
to
a
conclusion
on
what
needs
to
be
done
with
the
fraud
issue.

Chris
Hornback:
Chris
Hornback
with
the
Association
of
Metropolitan
Sewage
Agencies.
I've
heard
a
lot
of
comments
from
companies,
Monsanto,
Dow,
Procter
&
Gamble.
I
wanted
to
just
represent
or
at
least
give
you
some
thoughts
from
the
publicly
owned
world,
the
publicly
owned
treatment
works.
AMSA
represents
over
260
of
the
nation's
publicly
owned
treatment
works.
Our
members
treat
the
majority
of
the
wastewater
generated
in
this
country,
both
residential
and
industrial.

We
present
an
interesting
case
study
for
this
particular
rule­
making.
Not
only
are
our
members
permittees
under
the
[
National
Pollution
Discharge
Elimination
System]
permit
program,
we
collect
information,
we
monitor
our
discharges,
we
prepare
DMRs
or
discharge
monitoring
reports
for
our
permit
requirements.
But
many
of
our
members,
actually
most
of
our
members,
are
also
running
approved
pre­
treatment
programs,
96
which
may
in
fact
control
a
lot
of
you
here
in
terms
of
your
industrial
discharges,
indirect
discharges
to
publicly
owned
treatment
works.
In
those
instances,
we
are
also
operating
essentially
a
regulatory
program.
We
are
control
authorities
and
we
would
in
fact
be
receiving
reports
from
many
of
you.
We
may
be
receiving
electronic
reports
from
many
of
you.

Many
of
our
members
are
investing
thousands
if
not
hundreds
of
thousands
of
dollars
in
information
management
systems
to
receive
the
information
from
many
of
you.
In
that
case,
we
are
not
only
subject
to
the
electronic
record­
keeping
requirements
but
the
electronic
reporting
requirements,
and
in
terms
of
the
data
reception,
not
only
are
we
sending
the
data
out
but
we're
receiving
it
as
well.
So
our
systems
are
going
to
have
to
comply
with
those
portions
of
the
rule
as
well.

So
we've
got
a
lot
to
deal
with
with
this
rule,
and
so
we
definitely
support
the
separation
or
decoupling
of
these
proposals.
We
would
be
interested
in
talking
more
with
the
agency
about
the
reporting
requirements
and
the
challenges
that
those
present
for
our
members.

Howard
Krueger:
This
is
a
follow­
up
point
on
the
last
point,
which
I
thought
was
very
good.
If
we
were
to
create
a
meeting
and
schedule
a
meeting
to
focus
on
the
reporting
parts,

we
all
must
remember,
or
at
least
as
disclosed
in
the
economic
impact
analysis
that
the
EPA
had
done
for
it,
the
62­
page
97
report
by
that
outside
company.
It's
either
80
but
I
believe
it's
90
percent
of
all
reporting
against
EPA
regulations
goes
to
states
and
tribes.
That's
an
overwhelming
amount
of
reports
going
to
this,
I'll
call
it
a
third
party,
but
it's
not
the
EPA
in
Washington,
D.
C.
It's
these
other
groups.
So
not
to
consult
them
as
part
of
any
sort
of
review
on
reporting
would
be
to
miss
the
boat,
I
think,
on
getting
some
very
important
information.
That's
just
kind
of
a
reminder
following
up
on
the
very
valid
point
made
here.
The
states
have
to
be
brought
in
because
they
have
the
programs
that
receive
the
data
and
when
they're
getting
90
percent
of
the
information
they're
really
the
main
player.

Unidentified
Male
Speaker:
I
think
that's
a
really
good
point,
Howard,
and
in
fact
we
have
sort
of
a
separate
or
additional
process
where
we're
consulting
with
states.
There's
one
person
here
from
one
of
those
state
groups
that
we've
been
talking
to
that
we're
working
on
plans
to
do
that.

Robin
Roberts:
Are
there
any
other
questions
about
the
alternatives?
There
seems
to
be
a
 
I
hate
to
use
the
word
consensus,
but
consensus
about
decoupling.

Unidentified
Male
Speaker:
In
terms
of
addressing
reliability
of
electronic
records,
if
you're
starting
with
a
fresh
slate,
as
it
were,
an
appropriate
model
to
think
about
would
be
the
model
that's
presented
in
the
E­
Sign
Act.
The
98
electronic
signatures
act
has
a
provision
that
requires
if
a
statute,
regulation,
etc.,
requires
that
a
contract
or
other
record
relating
to
a
transaction
affecting
commerce
be
retained,
that
requirement
is
met
by
retaining
an
electronic
record
of
the
information,
so
long
as
the
record
accurately
reflects
the
information
and
remains
accessible
to
all
persons
who
are
entitled
to
access
the
statute
by
regulation,
etc.,
in
a
form
capable
of
being
accurately
reproduced
for
later
reference,
whether
by
transmission,
printing
or
otherwise.

The
e­
sign
legislation
with
those
provisions
is
interesting
for
a
number
of
reasons.
One
is
that
it
allows
printing
as
a
storage
option.
The
second
is,
it
has
almost
no
requirements
other
than
a
performance
requirement
that
the
record
accurately
reflect
the
information.
If
that
kind
of
undetailed
performance
standard
was
considered
by
the
Congress
of
the
United
States
to
be
good
enough
for
the
transactions
that
are
covered
by
the
e­
sign
legislation,
then
as
a
matter
of
public
policy
it's
probably
appropriate
to
consider
them
to
be
sufficiently
stringent
for
records
required
to
be
kept
to
meet
EPA
record­
keeping
requirements.

After
all,
the
e­
sign
legislation
addresses
transactions
that
involve
thousands,
millions,
billions
of
dollars.
There's
certainly
plenty
of
incentive
in
terms
of
money
at
stake
to
commit
fraud,
and
yet
Congress
determined
that
the
interest
in
99
having
a
free
flow
of
electronic
commerce
was
such
that
the
kinds
of
risks
could
be
managed
by
a
standard
that
simply
says
the
electronic
record
must
accurately
reflect
the
information.

The
e­
sign
legislation
goes
on
to
say
that
agencies
can
impose
appropriate
limitations,
but
the
legislative
history
of
that
provision
indicates
that
those
conditions
on
acceptability
are
to
be
minimal.
The
interpretive
standards
that
the
legislation
talks
about
must
be
such
that
they
are
substantively
equivalent
to
the
requirements
imposed
on
records
that
are
not
electronic
records,
so
they
can't
be
more
restrictive
than
those
applicable
to
paper
records,
and
they
will
not
impose
unreasonable
costs
on
the
acceptance
and
use
of
electronic
records.

So
there
is
a
clear
public
policy
expression
here
of
concern
about
the
cost
of
anti­
fraud
provisions.
Again,
if
these
kinds
of
minimal
restrictions
on
electronic
recordkeeping
in
commerce
were
articulated
by
Congress,
for
all
kinds
of
records
other
than
records
required
for
government
recordkeeping
requirements,
and
that
one
exception
was
carved
out
without
addressing
what
was
appropriate
for
government
recordkeeping
requirements,
EPA
is
certainly
in
a
position
to
say
what's
good
enough
for
everything
else
is
also
good
enough
for
us,
unless
there
are
very
specific
circumstances
that
would
suggest
that
something
more
is
needed.
That
something
more
100
would
need
to
be
justified
in
terms
of
both
need
and
cost.

So
the
e­
sign
legislation
would
be
a
good
source
of
inspiration
for
designing
an
alternative
to
the
current
proposed
regulations.

Lamont
Silves:
Lamont
Silves
with
Computer
Sciences
Corporation.
It
looks
to
me
like
what
we're
essentially
trying
to
do
here
is
to
promulgate
a
top­
down
solution.
I
would
urge
you
to
take
a
look
at
this
from
a
different
perspective.
That
would
be
it's
fairly
clear
that
the
regulated
community
is
already
keeping
electronic
records.
You
could
work
with
some
of
the
trade
associations
that
are
here
today
to
identify
the
best
practices
that
they
use
currently,
because
that's
what
you're
fundamentally
trying
to
do
is
find
a
best­
practice
approach
to
this.
So
you
could
work
with
these
folks
to
find
the
best
practices
that
they're
using
today,
validate
that
with
the
requirements
of
the
program
offices
and
take
that
approach
to
trying
to
find
a
workable
solution.

Kathy
Barrowclough:
I'd
like
to
follow
up
with
Mr.

Duvall's
recent
comment,
where
he
was
referring
to
the
e­
sign
law.
One
of
the
other
things
that
I
read
in
there
is
in
addition
to
what
he
mentioned,
he
talks
about
the
record
 
or
the
e­
sign
law
talks
about
the
record
after
it
was
first
generated
in
its
final
form.
If
you
take
that
piece
a
little
bit
further,
what
you
can
see
is
that
perhaps
you
wouldn't
need
101
all
the
audit
trails
on
some
of
the
draft
documents
that
might
be
created
on
some
of
the
lab
instruments
that
have
integration
and
reintegration
but
you
get
the
final
form,
and
that's
where
you've
got
your
record.
Just
wanted
to
bring
that
point
up.

George
Britton:
George
Britton
with
Aventis
CropScience.

One
of
the
things
in
the
area
of
electronic
records
and
how
you
do
things
from
[
Federal
Insecticide,
Fungicide
and
Rodenticide
Act]
side
of
the
house
and
particularly
[
Good
Laboratory
Practices]
in
particular,
historically
our
laboratory
instruments
integrate
peaks
and
signals
from
equipment.
Early
on
it
was
on
thermal
paper.
The
agency,
because
that
is
not
a
permanent
record,
we
have
photocopied
that
information.

Because
the
early
integrators
did
not
save
data,
they
just
[
inaudible],
processed,
spit
it
out,
re­
erased
it
and
went
on.

Over
time
we've
gone
to
other
chromatographic
systems.
We've
taken
the
same
approach,
we
print
the
chromatograms
and
the
information
data
that's
with
that,
sign
and
date
it
and
save
it.

Because
our
chromatography
systems
over
time
do
evolve
between
the
same
vendor,
between
different
vendors,
in
mergers,

you
get
all
kinds
of
things
that
are
totally
incompatible
and
you
never
can
get
the
pieces
together
no
matter
how
hard
you
try
to
get
it
readable,
much
less
functional.
So
what
we've
done
is
over
time
we're
now
taking
the
paper
for
a
limited
102
period
of
time
of
a
period
of
three
to
four
years,
five
years,

periods,
these
systems
are
operational.
You
could
go
back
within
a
reasonable
audit
period,
go
back
to
the
systems
and
verify
that
the
paper
is
exactly
what
comes
from
the
electronic
record.

You
can
do
that
over
and
over
again.
But
as
that
system
becomes
unusable
or
technology
out
of
date,
you've
still
got
the
paper
record
captured
image
of
it.

So
at
the
end
of
this
day,
we
are
in
the
process
of
imaging
it
to
an
electronic
medium.
In
order
to
have
the
information
available
to
whoever
needs
to
see
it,
if
the
agency
comes
in
to
handle
it,
let
me
see
the
raw
data
for
this
thing,

we
can
actually
handle
it
and
manipulate
it
back.
We've
still
got
the
paper
stored
offsite
somewhere.
The
electronic
version
or
image
capture
of
it
is,
as
the
gentleman
talked
earlier
about
the
formatting
 
long­
term
storage
problem,
that
you
can
see
as
a
snapshot.
You
can
go
back
and
view,
if
you're
trying
to
detect
fraud,
does
what
was
reported
match
what's
in
the
files,
you
can
go
back
and
compare
the
two.

With
that
you
have
gotten
sort
of
the
best
of
both
worlds.

In
our
particular
case
is
a
particular
paper
system,
but
it
does
give
you
the
ability
to
do
electronically,
submit
electronically
and
find
the
stuff
in
there.
It
also
gives
you
things
like
for
the
archiving
or
information
that
is
required
103
under
[
Good
Laboratory
Practices],
that
you
have
to
be
able
to
find
the
stuff
quickly
when
the
agency
comes
in
and
wants
to
view
the
stuff.
Yes,
we
have
it
on
paper
or
have
it
somewhere.

But
if
we
have
an
information
retrieval
scenario
where
you
say,

this
study
is
located
in
this
place
or
on
this
CD,
you're
protecting
the
information,
you're
trying
to
do
both.

The
functionality
of
the
long­
term
storage
is
the
real,
at
least
for
the
[
Good
Laboratory
Practice]
side
of
the
house,
is
the
real
key.
You
have
problems,
policies
and
procedures
in
place
to
ensure
the
security
and
integrity
of
the
information.

But
keeping
it
functional
electronically
over
time
is
the
big
point.

Charles
Reese:
I
just
wanted
to
add
a
comment
to
that,

that
since
we
currently
take
on
[
Federal
Insecticide,
Fungicide
and
Rodenticide
Act]
side
of
things
the
paper
printout
to
be
the
acceptable
raw
data
 
and
I
want
to
make
a
note
here
that
that
is
considered
an
acceptable
practice
by
the
agency
currently,
which
is
essentially
a
snapshot
of
what
is
going
on
in
that
electronic
record.
We
print
that
paper
out;
that
is
saved
in
the
archives.
If
a
company
so
chooses
to
image
that
system
for
their
own
benefit
because
they
transfer
archives
and
so
forth,
that's
fine.
But
the
important
point
here
is
that
taking
that
snapshot
on
paper
is
considered
an
acceptable
practice
by
the
agency
in
the
means
of
getting
an
audit
of
the
104
raw
data,
what
the
original
raw
data
is.

As
CROMERRR
is
written
right
now,
the
concerns
that
we
really
have
are
you're
changing
the
definition
of
what
original
raw
data
is
for
us.
We
say
it's
the
paper
printout.
CROMERRR
says
it's
the
electronic
record
that's
saved
now.
That
creates
a
whole
different,
we've
already
gone
over
all
these
problems
that
creates.
But
the
question
of
a
possible
alternative
that
can
be
raised
is
if
you
can
take
a
snapshot
and
put
it
on
paper,
how
is
it
that
you
cannot
take
a
snapshot
and
put
it
electronically
in
something
that
you
can
maintain
for
a
longer
period
of
time,
instead
of
trying
to
maintain
the
original
raw
data
that's
going
to
evolve
and
change
and
you're
going
to
have
trouble
with.
But
you
could
possibly
take
a
snapshot
electronically
and
keep
that.

The
argument
that
we've
heard
from
the
agency
over
this
is
that
you
don't
get
to
keep
 
you
don't
have
the
meta
data
that
generated
that
file,
all
the
audit
trails
and
so
forth
and
the
instrument
parameters
and
everything
that's
saved
in
the
electronic
file
that's
not
on
that
printout.
It
wouldn't
be
on
that
snapshot
of
say
a
TIF
image
of
some
sort.
But
we're
also
submitting
here
that
it's
not
on
the
raw
data
printout
either
and
that's
considered
an
acceptable
form
of
raw
data.
So
we
want
to
make
that
point
and
raise
caution
that
we're
changing
the
definitions
of
what
original
raw
data
is.
105
Tammy
White:
My
name
is
Tammy
White
and
I
am
from
Rutgers
University,
New
Jersey.
I'm
part
of
the
IR­
4
program,
which
we
have
a
couple
things
happening
here.
We
are
a
United
States
Department
of
Agriculture­
funded
program,
which
means
we
have
limited
funds
in
order
to
accomplish
the
work
that
we
do
on
behalf
of
the
growers
of
this
country.
A
point
that
was
just
made
was
that
there
have
been
precedents
for
the
acceptability
of
this
data
that
was
generated
using
computer­
based
systems
in
a
printout
form.
Earlier
it
was
mentioned
that
when
putting
CROMERRR
together,
that
Part
11
from
the
Federal
Drug
Administration
side
was
utilized
as
well
as
the
[
inaudible].

But
I
think
there's
another
precedent
that
is
there,
and
please
if
someone
can
add
onto
it.
Within
the
[
Organization
for
Economic
Cooperation
and
Development,
Good
Laboratory
Practice]

scope,
the
permissibility
of
using
that
printout
as
the
original
data
has
been
established.
So
I
think
that
there's
precedents
already
established
for
that.

On
behalf
of
IR­
4,
I
can't
reiterate
enough
the
cost
of
trying
to
implement
the
data
retention
systems,
and
to
try
to
revamp
the
data
collection
systems
over
time
is
an
enormous
expense
on
a
program
that
we
currently
 
we
have
very
limited
funds.
When
trying
to
accomplish
a
grant­
funded
program
and
trying
to
be
as
efficient
in
that
program
and
having
a
requirement
such
as
CROMERRR
placed
on
top
of
us,
the
106
efficiency
that
we
would
lose
would
just
be
enormous.

Robin
Roberts:
Could
I
see
a
show
of
hands
of
those
in
favor
of
decoupling?
I'm
not
sure
who
wouldn't
have
their
hands
up.
And
the
whole
notion
of
a
work
group
to
work
on
a
narrow
issue
of
doing
a
time­
sensitive
security
or
fraud
provision?
Are
there
any
other
comments?
There's
one
over
here
and
then
after
that
we'll
probably
take
a
break
here.

Paul
Toll:
I'm
Paul
Toll
with
the
Bayer
Corporation.

Just
kind
of
side
with
what
Charles
said
earlier
and
Tammy
just
said,
I
think
even
if
we
aren't
going
to
decouple
the
records
part
of
it
from
the
reporting
and
signatures,
I
think
all
these
companies
or
at
least
[
Federal
Insecticide,
Fungicide
and
Rodenticide
Act]
arena
are
pretty
much
global
companies.
We've
got
work
that's
going
on
over
in
Europe,
even
for
registrations
here
in
the
U.
S.
To
have
a
different
set
of
rules
here
in
the
U.
S.
than
what
they
have
in
Europe
is
very
troublesome,
and
the
harmonization
of
those
types
of
situations
would
be
very
beneficial.
I
would
suggest
that
you
also
look
and
see
what
[
Organization
for
Economic
Cooperation
and
Development]
has
already
in
this
arena.

Robin
Roberts:
There
are
a
couple
of
options
here.
We
could
take
a
break
now
or
we
could
go
to
the
next
section
here,

which
is
what
special
interests
are
raised
by
CROMERRR
criteria
for
long­
term
archiving.
I've
got
a
feeling
we've
kind
of
hit
107
on
that
already.

Before
we
come
back
for
that,
why
don't
we
break
now.

It's
just
been
suggested
that
in
addition
to
just
the
issues
that
you'd
like
to
comment
on
regarding
electronic
recordkeeping
if
there
are
other
 
the
other
sections
of
the
rule,

A,
B
and
D,
that
you'd
also
like
to
comment
on,
we'll
have
a
brief
period
of
time
for
that
later
on
in
the
day
before
we
recap
everything
at
the
end
of
the
meeting
here.
So
keep
that
in
mind.
So
if
you
have
something
on
your
mind
that
you'd
like
to
say
that
doesn't
fall
within
the
scope
of
this
meeting
as
defined
by
the
agenda,
we'll
have
an
opportunity
for
you
to
say
your
piece.
Let's
take
a
break
for
fifteen
minutes,
that
means
we
come
back
at
ten
to
three.

[
End
of
Tape
2]

[
Tape
3
of
3]

EPA,
Unidentified
Male
Speaker:
I
heard
these
from
a
couple
of
people
and
I
just
want
to
see
how
other
folks
feel
about
these.
We
had
one
suggestion
and
I
also
received
a
lengthy
written
comment
about
the
idea
of
basically
substituting
the
e­
sign
criteria
for
record­
keeping,
which
I
think
Mr.
Duvall
read
to
you
here
a
while
ago.
It
basically
says
accuracy
and
accessibility
and
describes
a
little
bit,
a
few
sentences,
about
what
that
might
be
about.
So
I
wasn't
clear
whether
your
particular
suggestion
was
just
substituting
108
those
criteria
for
the
ones
that
we
had.
I
did
have
a
written
comment
that
suggested
doing
that.
I
was
just
wondering,
from
kind
of
asking
other
people
in
the
room
what
they
think,

whether
that
would
be
useful,
appropriate,
helpful,
too
general,
whatever.

Mark
Duvall:
The
e­
sign
legislation
I
think
is
an
appropriate
model
to
think
about.
I
don't
think
we've
thought
about
it
hard
enough
yet
to
say
this
is
the
right
answer.
But
it
certainly
is
suggestive
that
a
less
detailed,
less
regulatory
approach
might
well
be
sufficient.

EPA,
Unidentified
Male
Speaker:
One
of
the
reasons
perhaps
for
doing
that,
if
we
were
to
do
that,
is
that
because
e­
sign
specifically
excludes
reports
specifically
designed
in
response
to
a
federal
requirement
from
those
requirements,

right
now
e­
sign
doesn't
apply
to
that
kind
of
records
or
those
kinds
of
record­
keeping.
So
this
would
essentially
bring
those
requirements,
which
are
fairly
general
but
important,
that
would
bring
those
into
the
record­
keeping
for
EPA.
Any
thoughts
from
anyone
else?

Robin
Roberts:
I'd
like
to
encourage
any
other
comments
from
any
of
you
who
are
familiar
with
e­
sign
legislation
and
the
difficulty
perhaps
in
extending
it
to
EPA­
required
records.

Unidentified
Male
Speaker:
Just
from
what
I
heard
about
e­
sign
as
it
was
being
described,
it
sounds
as
if
that
would
109
apply
more
logically
if
you
need
to
apply
something
on
the
reporting
side.
I
think
it's
still
a
separate
issue
whether
anything
at
all
is
needed
on
the
record­
keeping
side.
I'd
still
draw
that
distinction.

Mark
Greenwood:
One
thought,
this
really
is
in
the
nature
of
a
question.
I
think
we
all
would
be
curious
to
see
how
other
parts
of
the
government
are
responding
to
the
[
Government
Paperwork
Elimination
Act].
We
know
about
the
[
Federal
Drug
Administration]
requirements,
I
think
you've
heard
a
lot
of
people
expressing
deep
concerns
about
how
those
are
set
up.

But
after
all,
the
[
Government
Paperwork
Elimination
Act]
is
a
government­
wide
requirement.
I'm
curious
how
other
agencies
are
trying
to
deal
with
these
kinds
of
issues.
There
may
be
some
other
models
out
there
that
will
provide
some
consistency
that
would
be
useful
to
look
at.
I
would
just
pose
that,
if
you
know,
and
if
not
that's
a
good
kind
of
action
item
to
go
look
at.

Howard
Krueger:
I
do
support
e­
sign
as
another
model,

which
I
think
is
a
valued
alternative.
What
I
think
we
ought
to
consider
is
put
that
on
the
table
adjacent
to
the
CROMERRR
nine
criteria
and
then
let
EPA
in
particular
identify
areas
in
e­
sign
where
they
find
that
it
may
not
measure
up
to
the
standards
or
the
need
that
they
have.
So
e­
sign
may
not
be
a
perfect
answer,
but
I
think
if
you
were
going
to
try
to
solve
a
110
problem
and
you
had
to
pick
one
or
the
other,
I
would
certainly
vote
that
you
pick
e­
sign.
But
we
could
work
and
make
it
even
better,
I
think.
I
don't
think
it's
the
answer
in
and
of
itself.

Mark
Duvall:
Responding
to
Mark
Greenwood's
inquiry
about
what
are
other
federal
agencies
doing
under
the
Government
Paperwork
Elimination
Act,
the
Government[
sic]
Accounting
Office
in
September
2001
did
an
update
on
what
other
agencies
are
doing.
It's
interesting
that
with
respect
to
high­
risk
transactions,
and
this
is
mainly
a
reporting
issue
rather
than
a
record­
keeping
issue,
twenty­
two
different
agencies
had
identified
high­
risk
transactions,
a
total
of
249
high­
risk
activities.
So
twenty­
two
other
agencies
have
gone
through
the
kind
of
risk
assessment
that
[
Office
of
Management
and
Budget]

called
for.
Of
those
249
high­
risk
activities
that
were
identified
by
these
twenty­
two
agencies,
forty­
three
or
17
percent
of
them,
the
agencies
planned
to
use
the
electronic
transactions,
electronic
reporting
option
anyway.

So
it's
clear
that
outside
of
EPA,
there
is
a
process
going
on,
more
to
greater
or
lesser
degrees,
of
considering
whether
fraud
is
a
concern
in
particular
applications,

identifying
those
applications
where
it's
a
concern
and
then
making
a
reasoned
decision
whether
or
not
additional
protections
are
needed
to
prevent
fraud.
111
I
might
also
mention
that
the
National
Archives
recently,

December
10,
2001,
put
out
a
report
on
current
record­
keeping
practices
within
the
federal
government.
The
bottom
line
there
was
that
government
agencies
are
not
prepared
themselves
to
keep
records
electronically.
If
I
could
just
read
a
couple
of
sentences.
"
Technology
tools
for
managing
electronic
records
do
not
exist
in
most
agencies.
Despite
the
growth
of
electronic
media,
agency
record
systems
are
predominantly
in
paper
format
rather
than
electronic.
Virtually
every
agency
visited"
 
and
there
are
150
agencies
covered
in
this
report
 
"
indicated
that
the
official
policy
is
that
their
records
will
be
maintained
in
paper
format.
The
predominant
e­
mail
policy
is
to
print
out
e­
mails
that
are
considered
records
and
to
save
the
paper
copies.
The
chief
paradox
of
today's
federal
records
management
is
the
disconnect
between
paper
and
electronic
record­
keeping."

So
if
EPA
is
asking
industry
to
keep
records
electronically
for
very
extended
periods
of
time,
it
should
do
so
with
the
recognition
that
the
federal
government
itself
is
having
a
very
difficult
time
grappling
with
the
same
problem,

given
all
the
federal
government's
resources.
When
we
consider
that
small
businesses,
states
as
well
as
medium
and
large­
sized
companies
are
covered
by
EPA
record­
keeping
requirements,
it's
worth
having
considerable
pause
about
imposing
long­
term
112
archiving
requirements
that
the
federal
government
itself
is
having
difficulty
meeting.

Unidentified
Male
Speaker:
I
just
want
to
cite
the
[
Securities
and
Exchange
Commission]
EDGAR
system
and
the
filing
that's
done,
which
is
a
lot
of
security's
required
for
the
securities
filings
that
are
done
at
the
[
Securities
and
Exchange
Commission].
They're
on
to
their
third
generation
of
technology
and
in
fact,
the
reporting
that's
done,
you
can
pull
the
software
off
of
the
web
site
that
facilitates
the
electronic
filing
of
submissions.
That
is
one
model
I
think
that
should
be
considered
with
respect
to
certain
programs.

The
thrust
of
CROMERRR
on
some
level
is
to
facilitate
electronic
reporting
for
many
different
reasons.

I
think
a
useful
model
is
what
the
[
Securities
and
Exchange
Commission]
has
done.
In
fact,
the
software
that
they've
developed
to
address
the
e­
sign
issues
and
other
issues,
some
of
which
get
into
the
audit
trail
capabilities
but
do
not
require
record­
keeping
independent
of
this
mechanism
for
electronic
reporting,
the
software
they
provide
from
their
own
web
site.

Unidentified
Male
Speaker:
I
do
have
another
question
but
I
just
also
want
to
respond
to
Mark's
comment
a
minute
ago.
We
contributed
to
that
report,
or
we
contributed
our
[
Government
Paperwork
Elimination
Act]
analysis
along
with
other
agencies.
113
One
of
those
high­
risk
reports
was
ours,
that
we
are
collecting
electronically
risk
management
plan,
as
an
example
of
that
kind
of
report
for
those
of
you
that
are
familiar
with
that.
But
that
really
does
refer
to
electronic
reporting,
those
high­
risk
areas.
So
it
doesn't
really
refer
to
the
record­
keeping
part
of
it.

I
guess
I
would
also
say
yes,
another
part
of
our
office,

not
my
group
but
another
part
of
our
office
of
information
collection
is
in
charge
of
record
retention
for
EPA.
They're
struggling
with
many
of
these
very
same
issues.

I
guess
the
thing
is
that
I
think
maybe
either
 
what
you
said
was
that
if
EPA
is
requiring
people
to
keep
electronic
records
for
long
periods
of
time,
then
we
need
 
what
we're
really
saying
is
you
can
keep
paper
records
if
you
want.
It's
just
that
if
you're
going
to
keep
electronic
records,
there's
some
requirements
that
should
be
associated
with
it.
So
it's
not
that
we're
saying
you
have
to
keep
electronic
records
but
we
don't
know
how
to
do
it.
We're
saying
if
you
want
to
keep
electronic
records,
here's
some
requirements
that
should
be
associated
with
it.

There's
another
option
that
was
I
think
raised
by
a
couple
of
people
earlier,
was
that
rather
than
focus
on
something
like
an
audit
trail
requirement
that
maybe
it
would
make
more
sense
to
do
something
like
have
people
document
what
their
system
is
114
for
ensuring
integrity
and
accuracy
for
their
records.
I
thought
that
was
kind
of
an
interesting
idea
because
you
could
attach
that
to
a
more
general
kind
of
performance
requirement
and
then
people
just
sort
of
 
it
would
allow
variations
depending
on
people's
different
approaches
or
different
software
and
stuff.

So
I
thought
that
was
kind
of
an
interesting
idea,
but
I
also
 
I
had
as
an
old
paperwork
reduction
person,
I
was
also
concerned
about
what
that
might
mean
for
companies
in
terms
of
costs
and
in
terms
of
a
new
sort
of
document
that
people
would
have
to
create.
So
I
was
also
just
interested
in
getting
some
kind
of
broader
thinking
about
that
idea.
I
think
it
was
John
Chellen
and
somebody
else
originally
suggested
that
this
morning,
that
some
kind
of
documentation
system
for
how
you
preserve
and
protect
your
records
might
be
a
better
substitute
for
some
kind
of
thing,
rather
than
like
an
audit
trail
requirement.
Any
other
thoughts
about
that?

Robin
Roberts:
So
alternatives
to
the
audit
trail
requirement.
Who
had
raised
that
point
or
who
would
like
to
speak
to
that
point
earlier?
We've
all
noted
that
audit
trail
as
stated
in
the
rule
is
pretty
cumbersome
and
this
is
a
way
that
we
could
suggest
that
they
be
documented
and
preserved,

protected.

Jim
Scialabba:
I
recommended
earlier
a
record­
keeping
115
management
system
be
substituted
as
a
performance
standard
rather
than
prescriptive.
In
fact,
I
believe
probably
every
company
in
here
already
has
a
written
records
retention
policy
in
their
company
that
would
serve
as
a
platform
from
which
a
record
management
system
document
could
be
developed.
In
fact
right
now
I
have
some
of
our
corporate
attorneys
who
wrote
the
original
record
retention
policy
looking
at
the
implications
of
CROMERRR
on
our
internal
records
system.
So
I
don't
think
it
would
be
all
that
cost­
burdensome
to
companies.
Again,
I
like
the
fact
that
it
would
allow
for
the
inclusion
of
innovation
in
technology,
where
a
lot
of
times
we
wouldn't
even
have
to
change
our
system.
We
would
just
incorporate
new
technology,

as
long
as
it
met
the
minimum
criteria
of
the
performance
standard
that
EPA
would
outline
for
us.

David
Schwarz:
Just
a
question.
A
number
of
people
at
this
meeting
and
actually
a
number
of
people
at
preceding
meetings
mentioned
the
[
Organization
for
Economic
Cooperation
and
Development]
standards.
Those
standards
are
I
think
very
interesting
and
we've
looked
at
them.
I
guess
I'm
curious,
and
this
is
a
question
you
could
answer
now
or
you
could
give
us
comments,
but
I
think
we'd
be
very
interested
in
knowing
to
the
extent
that
you
think
the
[
Organization
for
Economic
Cooperation
and
Development]
consensus
document
standards
represent
an
approach.
Can
you
sort
of
identify
the
universe
116
of
records
that
you
think
they
are
best
applied
to?

Also,
I
did
note
I
think
when
I
read
them
that
they
do
in
fact
involve
an
audit
trail
requirement,
which
is
something
that
a
number
of
people
have
found
objectionable.
I
guess
I'd
be
curious
to
know
why
it
is
that
in
the
context
of
the
[
Organization
for
Economic
Cooperation
and
Development]

standards
the
audit
trail
requirement
is
really
not
objectionable,
yet
it
seems
to
be
objectionable
in
the
context
of
CROMERRR.

Jamie
Conrad:
Just
reflecting
on
the
sort
of
management
systems
approach
or
the
document
your
system
type,
I
guess
I
can
think
of
it
at
sort
of
two
levels.
One
would
be,
there
actually
would
be
an
affirmative
requirement
to
maintain
some
sort
of
a
records
management
system
which
maybe
would
be
part
of
your
record
retention
policy,
that
would
specify
the
things
you
do.
The
other
might
be,
and
that
would
be
sort
of
performance
oriented.

Another,
maybe
more
streamlined
approach,
which
I
guess
is
the
e­
sign
approach,
would
be
not
to
specify
that
requirement
per
se
but
to
say
that
you
have
to
have
procedures
or
mechanisms,
systems
in
place
to
ensure
that
your
records
are
maintained
accurately
and
with
integrity
and
so
on.
But
what
you
specifically
had
to
do
in
your
specific
case,
given
the
particular
record
in
case,
would
be
sort
of
done
on
a
case­
by­
117
case
basis.

If
someone
came
to
you
and
challenged
you
or
there
was
an
investigation
or
enforcement
case
involving
the
legitimacy
of
a
record,
you
would
have
the
burden
to
substantiate
what
you
did
in
order
to
meet
that
requirement.
But
it
would
be
a
case­

bycase
thing
as
opposed
to
saying
here's
the
specification
for
your
records
management
system,
show
me
how
you
meet
each
of
these
ten
elements.
So
I
think
you
could
do
it
either
way
under
this
framework
of
a
performance­
oriented
approach.

Robin
Roberts:
Now
we'll
go
on
to
this
question
of
[
Organization
for
Economic
Cooperation
and
Development]'
s
audit
trail
provisions
not
being
objectionable,
but
perhaps
CROMERRR's
being
objectionable.

Kathy
Barrowclough:
I
think
that
one
of
the
points
in
response
to
Mr.
Retzer,
I
believe
that
the
[
Organization
for
Economic
Cooperation
and
Development]
principles
issue
that
was
raised
was
as
an
alternative
in
some
cases
to
offer
another
option
of
printing
out,
and
not
to
make
it
so
that
that
would
be
the
answer.
That
would
be
my
read,
anyway.
Also,

recognizing
that
that
only
applies
to
one
kind
or
type
of
record
or
regulated
entity
within
the
EPA
community,
because
indeed
those
[
Organization
for
Economic
Cooperation
and
Development]
principles
relate
to
the
[
Good
Laboratory
Practices]
community
and
they
do
not
relate
to
the
rest
of
the
118
environmental
monitoring
community.

Mark
Duvall:
As
a
follow­
up
to
that,
the
[
Organization
for
Economic
Cooperation
and
Development]
principles
that
we're
talking
about
are
[
Organization
for
Economic
Cooperation
and
Development]
good
laboratory
practice
principles,
which
the
[
European
Union]
has
adopted
as
[
European
Union]
[
Good
Laboratory
Practices].
They
have
two
provisions
of
note.
One
is,
they
do
have
an
audit
trail
provision;
they
also
allow
paper
copies.
Today,
EPA's
[
Good
Laboratory
Practices]

regulations
have
an
audit
trail
requirement
and
allow
paper
copies.
The
concern
here
is
that
the
parallels
that
exist
between
the
European/[
Organization
for
Economic
Cooperation
and
Development]/
U.
S.
provisions
will
be
disrupted
by
changing
the
U.
S.
requirements
to
disallow
paper
copies.
The
reason
that
audit
trails
are
not
an
overwhelming
concern
under
the
[
Organization
for
Economic
Cooperation
and
Development]

principles
is
that
they
are
a
requirement
in
all
those
jurisdictions
that
either
endorse
the
[
Organization
for
Economic
Cooperation
and
Development]
or
the
U.
S.
requirements.

The
U.
S.
audit
trail
requirement
in
the
[
Good
Laboratory
Practices
regulations]
appears
at
40
CFR,
Section
160.30(
e).

There's
a
corresponding
provision
in
the
[
Toxic
Substance
Control
Act]
[
Good
Laboratory
Practices
regulations].

So
there
is
a
provision
now
for
audit
trails
in
the
[
Good
119
Laboratory
Practices]
context.
But
it's
limited
to
the
laboratory
context
and
it's
limited
not
only
to
laboratories
but
to
laboratories
conducting
studies
under
[
Good
Laboratory
Practices].
So
it's
quite
limited.

Charles
Reese:
I
wanted
to
clarify
a
little
bit
more
about
the
[
Organization
for
Economic
Cooperation
and
Development].
Obviously
when
we
read
the
[
Organization
for
Economic
Cooperation
and
Development]'
s,
they
seem
to
have
a
more
practical
approach.
Sometimes
Europeans
are
always,
what
can
you
really
do,
versus
what
do
you
think
you
should
do
approach.
But
we
have
to
make
sure
we're
also
talking
apples
to
apples
here,
because
I
don't
think
the
question
was
should
we
not
require
audit
trails
whatsoever
[
brief
noise
interruption].

It's
not
a
question
of
not
having
an
audit
trail
in
some
cases,
but
again
we
can
point
out
here
that
this
is
a
[
Good
Laboratory
Practices]
setting,
and
also
we're
also
talking
about
in
the
Part
160
there's
fifty­
seven
different
types
of
records
that
one
can
have.
In
an
audit
trail
system
in
the
[
Organization
for
Economic
Cooperation
and
Development]
system
and
listed
in
the
good
automated
laboratory
practice
systems,

GALP,
they
involve
laboratory
information
management
systems.

Therefore
data
collected
by
the
computer
system
that's
transferred
through
a
computer
network
and
somehow
has
the
120
opportunity
to
be
manipulated
through
that
computer
network
to
where
it
finally
resides.
The
GALPs
require
an
audit
trail,
so
anyone
doing
work
for
the
EPA
has
to
apply
the
GALPs.

I
don't
think
the
question
here
is
we're
concerned
about
 
because
taking
away
the
audit
trail,
if
you're
in
that
situation
where
you're
following
these
specific
guidelines
that
you
have
to
have
an
audit
trail,
in
a
[
Good
Laboratory
Practices]
setting
I
think
we're
saying
we're
okay
with
that.

The
[
Organization
for
Economic
Cooperation
and
Development]

gives
you
the
out
here
that
you
can
have
a
different
medium
if
your
system
becomes
obsolete.
But
that's
outside
of
 
there's
95
percent
of
the
rest
of
the
country
that's
dealing
with
environmental
monitoring
under
Title
XL
that's
not
a
[
Good
Laboratory
Practices]
setting.
I
think
those
are
other
concerns
when
it
comes
to
dealing
with
audit
trails.
So
from
my
particular
aspect,
there's
not
a
problem
with
audit
trails
under
those
specific
circumstances,
LIMs,
laboratory
information
management
systems.

Unidentified
Female
Speaker:
Just
one
other
point
on
that
same
issue
is
that
that
is
related
as
Charles
just
mentioned
to
the
laboratory
information
management
systems.
What
CROMERRR
will
do
is
broaden
the
records
that
would
be
managed
that
way
to
include
indexing
systems
and
SOPs
and
training
records
and
all
of
those
sorts
of
things
that
are
not
the
laboratory
121
information
management
systems
that
are
collecting
data.

Robin
Roberts:
Great.
Were
there
any
other
options
that
you
wanted
to
elaborate
further
on,
Joe,
that
you
heard
about
alternatives?

Joe
Retzer:
No.

Robin
Roberts:
Then
we'll
turn
to
the
next
section
of
the
agenda.
Although
these
issues
may
seem
or
we
have
talked
about
them,
it
seems
that
right
now
with
archiving,
current
practice
among
companies
is
to
print
the
paper
or
to
take
an
electronic
snapshot,
somehow
image
the
data
and
file
that.
That's
what
we
seem
to
have
heard.
This
section
is
intended
to
kind
of
delve
a
little
bit
more
deeply
into
your
current
archiving
practices.

So
the
question
I
guess
before
us
really
is,
is
printing
the
paper
and
archiving
that
and
entrusting
the
paper
to
an
archivist
who
has
a
duty
of
care
to
maintain
that
record
beyond
the
life
of
his
employment,
is
that
the
way
that
archiving
is
done?
Or
it's
snapshot
imaging,
the
data
now
and
then
perhaps
printing
that
paper,
the
way
that
archiving
is
done
now?

Charles
Reese:
Sorry
if
I
seem
like
I'm
talking
forever
here
today.
Yes,
with
the
archiving
issue,
the
paper
record
is,
the
printout
to
the
paper
record
is
the
current
practice
in
the
[
Good
Laboratory
Practices]
setting.
I
just
wanted
to
point
out,
also
with
what
Kathy
[
Barrowclough]
said,
that
if
you
include
e­
records
to
be
everything
and
you
require
and
122
we've
changed
our
definition
now
of
what
original
raw
data
is,

you
have
to
keep
this
original
raw
data
for
the
life
of
a
registration,
which
can
be
a
very
long
time,
we're
talking
decades,
especially
if
companies
merge,
products
get
sold
various
places.
The
kind
of
conditions
that
we
can
run
into
is
virtually
having
to
take
that
electronic
record
and
migrate
it
from
a
platform
A
to
platform
B
to
platform
C
over
time,
if
we
don't
have
that
[
Organization
for
Economic
Cooperation
and
Development]
out
that
we
were
given.

I
want
to
point
out,
and
I
can
probably
provide
for
you
later,
at
the
ACS
meeting
in
1999
in
Chicago,
there
was
a
team
of
lawyers
there
talking
about
the
migration
of
electronic
data
and
the
problems
with
that.
They
suggested
that
for
every
migration
that
you
do
on
a
data
system,
that
you
run
the
risk
of
losing
between
3­
5
percent
of
that
data
as
you
move
from
platform
to
platform.
They
said
that
virtually
no
matter
how
hard
you
try,
no
matter
how
much
effort
you
put
into
validating
and
to
make
sure
you
catch
every
little
piece
as
you
move
from
one
platform
to
the
next,
you
will
invariably
lose
between
3­
5
percent
of
that
data.

If
you've
got
fifty
years
to
go,
by
the
time
you've
migrated
to
that
fifth
platform
you
have
a
possibility
of
losing
25
percent
of
the
original
raw
data.
There's
a
significant
issue
there
of
compliance,
if
something
as
you
123
migrate
becomes
completely
irretrievable.
So
far
we
don't
have
solutions
or
answers
to
these
questions
yet
that
we
can
feel
comfortable
with,
outside
of
printing
out.

Robin
Roberts:
Migration,
loss
of
data
over
migration
through
different
generations
has
been
something
that's
come
up
in
our
other
meetings.

Unidentified
Female
Speaker:
I'd
like
to
first
add
a
couple
additional
issues
before
I
address
these.
Just
basically
the
maturity
of
the
technology
today
does
not
allow
businesses
to
comply
with
CROMERRR
as
it
is
written.
There
is
the
possibility
to
be
able
to
archive
and
manage
in
all
kinds
of
realms,
long­
term,
bringing
it
back,
all
that
kind
of
stuff.

Translation
from
machine
language
or
databases
or
whatever
to
human­
readable
forms
or
the
ability
or
some
form
of
archive
and
the
migration
of
this
information
from
legacy
systems
to
newer
systems,
now
introduces
the
concept
of
copies
of
data.
They
are
no
longer
the
original
raw
data
files,
they
are
copies.
So
what
are
the
conditions
that
CROMERRR
will
address
for
that?

Another
one
is
media
degradation.
Media
doesn't
live
for
thirty
years.
You
have
to
continually
retrieve
it.
Now
you're
making
another
copy
of
it,
you're
bringing
it
back
to
something,
you
put
it
on
new
media
and
you're
shipping
it
out
for
storage
again.
Again
you're
making
another
copy
of
it.

This
has
nothing
to
do
with
retrieving
it,
trying
to
read
it
or
124
anything,
this
is
just
maintaining
it
long­
term.

One
of
the
ones
that
was
mentioned
before,
I'll
just
bring
it
up
again,
is
setting
the
retention
periods
for
electronic
records
rather
than
imposing
existing
paper
requirements
on
the
electronic
records.
Again,
one
size
does
not
fit
all
for
the
definition
of
archival.
We
need
definitions
for
archival
requirements
for
the
different
types
of
systems
and
the
different
electronic
record­
keeping
systems
that
are
out
there.

This
is
kind
of
in
the
realm
of
the
data
collection
versus
data
manipulation
and
all
the
way
down
to,
for
example,
a
two­
year
study.
A
two­
year
study
could
produce
500­
800
megabytes,
but
one
analytical
method
development
can
generate
4
gigabytes
of
data.
So
there's
different
quantities,
there's
different
conditions
that
are
needed
depending
on
where
the
data
is
being
collected.
So
this
might
take
it
down
to
a
program
office
level
to
be
able
to
determine
that.

The
last
one
is
study
reconstruction
in
the
original
environment.
If
a
product
goes
to
market
for
thirty
years,
in
thirty
years
I'm
supposed
to
reconstruct
my
original
environment
to
bring
that
data
back?
That's
almost
impossible.

So
we
see
those
as
big
issues
for
long­
term
archiving.

One
of
the
additional
comments
against
an
issue
that
you
have
listed
is
that
I
just
wanted
to
concur
with
what
was
said
earlier
about
the
loss
of
data
between
whenever
migration
125
occurs
or
going
from
one
medium
to
the
next.
This
doesn't
have
to
do
with
losing
data
because
of
some
type
of
inadequate
conversion,
but
because
of
the
cause
of
technology
changing.

So
it's
not
that
the
systems
weren't
validated
and
the
actual
data
when
it
was
migrated
there
was
just
pieces
that
were
dropped
off
the
end
of
the
earth,
it's
the
fact
that
physically
it's
not
possible.

Paul
Toll:
I
just
wanted
to
reiterate
something
that
was
said
earlier
and
bring
it
into
the
current
discussion.
At
least
with
Bayer
Corporation,
we
do
a
lot
of
contracting
out
of
work.
To
assure
that
we
have
the
raw
data,
at
least
have
the
data
in
our
house
in
case
one
of
these
contract
[
inaudible]
go
out
of
business,
we
always
ask
that
all
the
data
be
sent
to
us
instead
of
having
it
archived
at
the
contract
facility.
Like
I
think
as
Charles
[
Reese]
said
earlier,
we
may
not
even
have
the
same
software
or
same
hardware
that
this
data
was
generated
on.

So
we
get
paper
printouts
of
the
raw
data
and
we
archive
those.

So
if
we're
going
to
have
to
try
to
archive
completely
in
electronic
form,
it
may
be
impossible
to
do.

Bill
Barta:
I
just
wanted
to
share
an
experience
with
migration.
I'm
not
an
IT
person,
I'm
quality
assurance,
but
just
to
give
you
a
qualitative
description.
We
migrated
some
images,
100,000
images
from
a
VAX
to
an
NT
server.
The
problems
we
had
was
corruption
of
files,
there
were
old
images.
126
Secondly,
another
thing
that
happens
is
we
went
to
a
different
platform,
the
software
we
were
using,
which
was
old
and
no
longer
supported
by
the
vendor,
developed
a
glitch
in
the
search
mechanism.
The
vendor
does
not
want
to
help
us
fix
it
because
they
no
longer
support
the
product.

Another
area
you
need
to
be
aware
of
is
that
even
though
manufacturers
like
Sony
say
that
their
optical
disks
last
fifty
years,
that's
a
projection
they
made.
If
you
bought
optical
disks
in
1992
and
the
head
that
reads
the
disk
broke,
it
was
probably
proprietary
and
you
can't
find
another
one
to
read
that
information.
So
you
would
have
a
problem
moving
it
to
somewhere
else
to
read
that
information.

The
issue
of
degradation
of
media
and
software
compatibility
is
a
very
large
one.
There's
probably
no
way
you
can
avoid
some
of
these
issues.
So
the
requirement
that
you
maintain
functionality
becomes
highly
problematical,
because
if
the
software
changes,
the
vendor
changes
it
to
improve
it,
and
you've
lost
something
that
you
consider
critical,
there
is
really
nothing
you
can
do
about
it.
In
theory,
the
agency
will
come
in
and
say
you've
done
something
really
bad
and
punish
you
for
it.
So
that's
the
scenario
I
see
happening.

Tammy
White:
My
name
is
Tammy
White,
I'm
with
the
IR­
4
program
with
the
USDA­
ARS
[
US
Department
of
Agriculture,

Agricultural
Research
Service].
One
of
the
problems
in
127
addition
to
the
things
that
have
been
reiterated
here
about
data
degradation,
the
media
degradation
and
things,
in
our
lab
in
particular
doing
the
chromatographic
analyses,
just
in
the
short
period
of
time
that
I've
been
doing
this
work
instruments
go
out
of
 
the
vendors
don't
support
them
anymore
and
you
end
up
with
a
media
that
can
only
be
run
on
a
particular
instrument.
You
can't
open
the
data
from
the
chem
station
without
having
the
instrument
attached
to
it.
So
you're
talking
that
we'd
have
to
archive
chromatographic
equipment
as
well
as
computer
equipment
and
software.

Then
you
run
into
the
problem
of
if
the
chromatograph
doesn't
function
because
a
board
goes
on
it
or
something
like
that,
the
vendor
isn't
supporting
it
anymore,
you
can't
get
the
part,
you
can't
turn
on
the
instrument.
Therefore
you
can't
even
get
to
the
software
and
get
something
that's
functional.

So
being
able
to
make
that
paper
copy
under
the
[
Good
Laboratory
Practices]
is
very
important
to
our
laboratory
in
particular,
just
for
being
able
to
archive
beyond
the
timeframes
of
an
instrument
surviving.
Thank
you.

Frank
Miller:
Just
a
couple
of
feedbacks
on
this
longterm
archiving,
mentioned
before
but
just
quickly
go
over
them
again.
The
storage
media
and
dealing
with
its
obsolescence
and
so
on
is
something
that
is
reasonably
achievable.
It's
not
the
easiest
thing
to
do,
but
you
can
do
it
and
you
can
do
a
128
validation
and
you
can
work
that.
I
guess
the
issues
you
run
into
are
eventually
getting
to
a
point
where
the
first
recording
of
data
is
really
not
available
anymore
and
you
have
to
live
with
the
subsequent
generations
of
that.

Around
the
area
of
meta
data
and
e­
signatures
and
connecting
that
up
to
the
actual
electronic
record,
that's
really
the
technology
and
so
on
is
fairly
new,
the
whole
concept
of
meta
data
and
so
on.
I
don't
think
there's
really
good
evidence
of
tools
and
applications
that
have
really
adopted
that
in
the
way
that
you're
intending
to
move
towards.

It's
too
emerging,
too
new
technology.
Certainly
it's
conceivable
that
we
could
work
in
that
direction,
but
nothing
off
the
shelf
really
that's
at
that
grade
of
that
today.

Then
the
other
area
that's
really
an
issue
is
just
the
whole
concept
of
application
obsolescence
and
migration,
and
the
ability
to
reconstruct
the
application
that
you
originally
had
and
be
able
to
preserve
that.
Unless
we
can
work
towards
vendors
that
survive
over
the
long
haul
and
they
eventually
take
over
the
marketplace
in
these
areas,
it's
going
to
be
difficult
if
not
impossible
to
keep
those
applications
and
that
business
logic
and
all
the
things
that
surround
how
the
electronic
record
was
created
for
long
retention
periods.

Mark
Greenwood:
I
want
to
reinforce
a
comment
I
made
earlier,
because
I
think
this
archiving
issue
really
does
129
highlight
the
fact
that
we
need
to
look
carefully
at
the
underlying
retention
periods
and
record­
keeping
requirements
themselves.
I
think
everybody
views
this
as
inevitability
that
we're
going
to
be
more
and
more
going
to
electronic
records.

There
are
these
archiving
problems.
We
are
often
looking
at
reporting
and
record­
keeping
requirements
that
are
a
quarter­
century
old,
that
were
not
carefully
thought
of
 
having
been
involved
in
some
of
those
myself
 
at
the
time.
It
is
a
time
to
really
go
back
and
start
looking
at
some
of
those
and
ask
the
question,
how
long
do
we
really
need
to
know
this?

What
do
we
need
to
know
about
something
that
happened
twenty
years
ago?
What
is
the
value
of
that
for
us
today
in
terms
of
managing
the
environment?
I
think
that's
a
fundamental
issue
that
I
know
you
can't
do
as
[
Office
of
Environmental
Information]
by
yourself,
but
it's
an
issue
that's
inevitably
going
to
have
to
be
part
of
this
discussion.

Mary
Catherine
Fish:
Mary
Catherine
Fish
with
MCF
Consulting.
I
think
that
this
archiving
criteria
may
also
go
to
a
point
that's
come
up
in
different
forms,
which
is
the
difference
between
possibly
the
intent
that
the
record­
keeping
requirements
would
not
create
additional
record­
keeping
requirements,
and
the
perception
that
it
in
fact
creates
a
whole
slew
of
new
record­
keeping
requirements.
Which
is
that
the
archiving
criteria
as
it's
written
requires
that
the
130
archiving
records
include
the
context,
the
meta
data,
the
audit
trail.
So
for
every
 
where
you
previously
had
one
requirement
to
preserve
a
required
record,
you
now
would
have
many.
So
there's
an
exponential
increase
of
the
requirement,
because
of
this
part
of
the
wording
of
the
archiving
requirement.

So
that's
one
mechanism
that
leads
to
the
problems
that
people
are
encountering,
as
part
of
what
makes
this
so
big.

It's
an
actual
 
we
can
go
back
to
the
basic
argument
over
whether
it's
voluntary
or
mandatory,
I
won't
get
into
that.

But
this
archiving
criteria,
I
think
is
really
one
of
the
concrete
ways
that
makes
this
proposal
a
great
expansion
of
what's
currently
required.
I
would
think
that
that
would
have
ramifications
all
down
the
line
in
terms
of
[
Information
Collection
Rules]
and
any
other
kind
of
analysis
that
EPA
is
going
to
do
about
how
onerous
or
burdensome
its
record­
keeping
requirements
are.

Mike
Penders:
This
discussion
has
illustrated
to
me
just
that
the
record­
keeping
requirements
are
not,
should
not
logically
function
as
a
condition
of
electronic
reporting
per
se,
but
pertain
to
the
precise
programs
and
technologies
and
monitoring
that
are
relevant
to
keeping
records
under
record
retention
requirements,
statute
by
statute,
program
by
program.

Really
I
think
it
has
brought
home
to
me
the
importance
of
decoupling
these
notions
and
letting
record
retention
evolve
131
with
technologies,
program
by
program,
that
meet
the
fraud
concerns
and
other
concerns
with
reference
to
the
technologies,

audit
trails,
that
are
particular
to
the
testing,
monitoring,

equipment
and
forms
of
auditing
that
may
be
required
under
those
programs,
but
do
not
relate
back
as
a
condition
of
electronic
reporting
per
se.

Jim
VanHorn:
One
of
the
things
I
don't
understand
what
information
technology
means
and
I
don't
speak
IT,
but
I
have
been
through
three
major
mainframe
computer
changes
in
the
positions
I've
been
in,
production,
quality
and
environmental.

I
have
been
through
one
complete
merger
of
two
companies
and
they
had
completely
different
systems
that
they
were
dealing
with
and
their
process
on
it.
Each
of
those
forced
things
on
it
required
a
year
or
a
year
and
a
half
of
pre­
planning,
then
there
was
the
implementation
of
crossover
on
it
to
do.
As
a
general
rule
it
was
a
year
before
they
were
stable.
In
every
instance
on
that,
we
still
had
things
in
that,
with
all
of
the
planning
and
as
much
input
as
was
put
into
it,
that
would
not
transfer.

So
this
is
just
an
example
of
some
of
the
things
that
I
have
been
seeing
that
go
through
that
point
out
the
problems
in
why
you're
not
going
to
get
100
percent
transfer
when
you
go
from
one
system
to
the
other.
I
just
know
for
a
fact
it
has
happened
that
way.
132
I
still
have
the
question
that
I
have
not
understood
the
[
inaudible]
of
it
as
to
what
the
magnitude
of
this
is
going
to
be
for
Smurfit­
Stone,
is
just
what
records
and
data
and
all
are
we
still
including
in
this?
Is
it
everything
in
our
facility
that
has
 
I
can
even
back
up
to
this
far
point
on
environmental
related?
Or
is
it
really
the
final
reports
that
we
submit
that
must
be
maintained
in
this
record
system?
If
it
is,
then
it
creates
a
much
less
of
a
concern
with
us
than
if
it
does
have
to
be
all
the
way
back
to
the
individual
data
that's
collected
throughout
all
of
the
processes.

Henry
Bartholomew:
Just
an
observation
on
archiving
in
general.
I
work
a
lot
with
folks
in
our
accounting
area
of
our
companies.
We've
run
into
the
same
discussion,
for
example
with
[
Federal
Energy
Regulatory
Commission]
and
the
[
Securities
an
d
Exchange
Commission],
on
long­
term
archiving
and
migration
and
so
forth.
Whether
people
need
to
keep
records
on
paper
or
electronically,
it
comes
as
you're
hearing
at
a
significant
cost.
It's
cost
of
space,
memory
if
it's
computer.
It's
cost
of
the
software,
it's
cost
of
personnel
to
do
that.

I
think
putting
this
as
a
third
issue
and
having
focus
on
the
individual
program
areas,
the
key
question
starts
with
what
information
do
companies
need
and
does
EPA
need
and
for
what
amount
of
time.
If
the
[
Internal
Revenue
Service]
for
tax
purposes
and
bring
in
the
money
that
runs
government
can
get
133
along
with
limited
timeframes
like
five
to
seven
years
worth
of
data,
maybe
that's
where
we
ought
to
be
thinking.
Again,

distinguish
between
report
information
that's
provided
EPA
and
[
inaudible]
of
reliability
for
that
versus
internal
information
that
may
lie
behind
that
but
be
necessary
to
company
operations.
What
EPA
should
be
focusing
on
is
the
former,
the
reporting
side,
but
not
all
the
other
information
that
goes
in
the
company.

So
several
things
come
out
of
that.
Look
for
short
timeframes,
do
it
program
by
program,
look
for
minimal
archiving
and
record­
keeping
long­
term
requirements,

distinguish
between
what
you
need
to
substantiate
on
the
reporting
side
from
what
companies
need
to
do
their
internal
operations
and
stay
the
heck
away
from
that.
Keep
it
as
short
as
possible,
recognizing
cost.
I
think
having
it
as
a
separate
exercise
makes
a
lot
of
sense.

Robin
Roberts:
We
have
at
least
one
more
comment.
I
would
just
like
to
say
that
the
war
stories
have
been
great,

they're
all
edifying.
But
I
would
like
to
turn
at
some
point
towards
a
more
solution­
oriented
sharing
of
experience.
Where
have
you
made
the
change?
We'll
just
segue
into
the
last
part
of
our
agenda,
if
we
can
make
that
transition.

Carolyn
Greenwood:
Most
of
what
I
was
going
to
say
was
just
said,
except
that
I
just
want
to
add
that
you
need
to
134
remember
that
when
people
 
we've
had
some
examples
of
companies
that
have
to
keep
a
lot
of
data
one
way
or
another.

They've
decided,
when
they
come
to
us
they
say
 
[
End
of
Tape
3,
Side
A;
Side
B
begins]

­­
they
have
to
manage
all
this
stuff
on
their
hard
drive.

Their
system
tends
to
get
slower,
they
get
more
frustrated
with
the
system
itself.
It
makes
it
more
tricky
for
the
software
folks
to
design
a
system
that
will
be
more
efficient,
because
it's
dragging
all
this
data
along
with
it.
So
to
kind
of
confirm
or
second
one
of
the
things
that
was
just
said,
I
think
program
by
program
is
the
way
you
want
to
do
this.
Some
people
need
to
keep
lots
of
data
and
some
people
don't.
It
would
be
real
unwieldy
for
some
folks
to
have
to
keep
a
lot
of
this
data,
only
because
you
wanted
to
have
it
consistent
across
all
the
programs.

Kathy
Barrowclough:
I
guess
in
response
to
what
Mr.

Roberts
just
asked,
get
away
from
war
stories
and
what
would
be
potential
solutions.
What
I
believe
I'm
hearing
is
we
don't
have
solutions
to
the
archiving
issues,
to
the
long­
term
archiving
issues.
There
are
issues
and
we
recognize
that,
but
we
don't
see
solutions.
One
of
the
potential
solutions
is
really
to
look
at
the
archiving
requirements,
the
record
retention
requirements,
and
maybe
reevaluate
those.

Charles
Reese:
But
I
like
war
stories,
and
what
better
135
way
to
give
you
an
example.
One
particular
example
just
springs
to
mind.
It
was
a
brilliant
idea
to
create
a
document
management
system
so
that
people
could
share
reports
throughout
the
company
without
having
to
physically
go
find
where
the
report
was
filed.
So
a
scanning
mechanism
was
put
in
place
to
scan
300,000,
600,000,
1.3
million
pages
of
documents
it
suddenly
turned
into,
as
they
thought
this
was
going
to
be
a
great
idea.

Halfway
into
doing
this
system,
the
company
that
we
had
had
the
proprietary
software,
set
up
our
system,
was
purchased
by
a
larger
company.
That
company
said,
that's
okay,
we
will
continue
to
support
the
older
system.
Which
lasted
a
year,
and
the
older
system
went
away
in
favor
of
the
 
it
was
a
competitor
buying
a
competitor,
now
they
favor
their
system.

It
literally
left
our
document
management
system
in
the
lurch.

To
purchase
new
system
software
and
reconfigure,
it
actually
took
a
manual
transfer
along
the
lines.
Right
when
we
got
finished
with
that,
another
merger
happened
and
you
see
where
this
is
going.

The
potential
for
mergers
in
the
software
industry
and
the
drop­
off
of
support
are
another
part
of
this
angle
that
you
worry
about
when
you're
trying
to
migrate
data
and
move
it
forward
and
keep
it
for
the
life
of
the
record
retention
period
that
you
have
to
keep
it.
You
may
lose
support
over
a
period
136
of
time
that
forces
you
into
a
different
scenario,
that
raises
your
costs
and
changes
your
platform
and
creates
frustration
across
the
board.
You
may
actually
reach
a
point
where
it
simply
can't
be
done
anymore.

Robin
Roberts:
I'd
just
be
curious,
Carol
[
sic]

[
Greenwood],
not
to
put
you
on
the
spot,
but
are
there
any
success
stories
you've
run
across?
You
just
mentioned
that
you
have
successfully
migrated
information
from
databases,
old
ones,
and
they've
become
unwieldy
and
slow.
But
is
there
some
really
sleek
operation
that's
 
finding
your
financial
statement
as
an
example
of
why
someone
would
hire
your
corporation?

Carolyn
Greenwood:
We've
done
lots
of
good
things.
I
don't
want
to
say
this
is
always
 
I
could
come
to
a
meeting
like
this
and
say,
make
it
as
hard
as
possible,
because
it
just
means
more
business
for
us.
But
obviously
what
we
want
out
of
this
is
something
 
we've
got
lots
of
stuff
on
our
plate
already,
so
I'm
not
begging
for
business.
What
we
really
want
out
of
this
is
a
clear
rule
that's
reasonable
for
everybody
to
work
with.
We
don't
want
frantic
customers
coming
to
us
with
emergency
needs
anymore
than
they
want
to
be
a
frantic
customer.

We
have
lots
of
success
stories.
We're
confident
we
can
do
whatever
comes
out
because
we
know
there's
enough
checks
on
137
the
system
that
you
guys
won't
go
too
crazy
with
what
you've
proposed.
But
I
think
the
bottom
line
of
it
all
is
yes,
the
things
you're
talking
about
even
now
could
be
done.
But
do
you
really
want
to
do
that
to
these
folks?
We
can
do
that
kind
of
stuff,
we
can
technologically
speaking
do
what
you're
talking
about,
all
the
different
things
you've
talked
about
doing.
But
it
means
a
big
burden
on
a
lot
of
folks
in
this
room.

Frankly,
we
don't
even
have
the
manpower
to
do
some
of
what
it
sounds
like
you're
talking
about.
If
all
our
customers
came
to
us
and
said,
all
the
utilities
and
state
agencies
and
local
agencies
came
to
us
and
said,
make
us
CROMERRR­
compliant,

in
its
worst
scenario
of
what
I've
heard
today,
we
would
just
scream
and
throw
up
our
hands
and
go,
slow
down,
wait,
how
long
have
we
got
to
do
this.
It
would
be
a
lot
of
work,
so
I
know
it
would
be
a
lot
of
cost
for
them.

That's
not
to
say
we
can't.
We
have
done
a
lot
of
successful
migrations.
We've
updated
a
lot
of
Part
75
systems,

acid
rain
systems,
where
the
way
we
migrated
the
data
was
through
EPA's
format.
If
it
was
another
vendor
and
maybe
they
went
out
of
business
or
whatever,
we
would
take
EPA's
format
as
the
common
ground
and
bring
that
up
into
our
system.
There's
ways
that
you
can
do
this
stuff,
but
I
don't
know
that
that's
the
question
here.
Maybe
I'm
misunderstanding
your
question.

Robin
Roberts:
So
the
glass
is
definitely
half­
empty?
No
138
success
stories
at
all,
no
hope
on
new
technology
delivering
us
from
this
paper
conundrum.

Frank
Miller:
A
comment
on
the
new
products
or
emerging
technologies.
Some
thoughts
around
the
idea
of
where
we
might
be
able
to
get
some
opportunity.
I
think
the
current
environment
for
environmental
health
and
safety
information
systems
and
so
on
is
somewhat
fragmented
and
there's
really
no
Goliath
in
the
marketplace.
Probably
the
same
appears
for
the
services
that
one
might
buy
around
information
services,
again,

specialties
and
niche­
driven,
maybe
no
large
vendor
that
can
own
it
all.

There
appears
to
be
some
good
movement
in
the
enterprise
business
systems
area
where
potentially
that
may
be
able
to
help
with
these
kinds
of
requirements.
Software
vendors,

there's
a
couple,
reasonable
amount
of
fairly
big
software
vendors
that
operate
in
this
area.
Many
of
them
appear
to
be
implementing
or
have
already
implemented
environmental
health
and
safety
modules
that
integrate
across
the
enterprise
and
take
advantage
of
information.

Almost
all
of
them
are
working
in
the
area
of
e­
business
type
technologies
to
make
sure
that
their
systems
can
play
in
that
area
and
can
offer
some
technologies
to
help
meet
some
of
these
requirements.
Many
of
them
either
strive
for,
have
methods
for
factory­
floor
integration
or
other
kinds
of
lower­
139
level
instrumentation
or
systems
integration.

Ideally
for
us
as
the
regulated
would
be
to
try
to
get
to
more
of
a
single
system
approach,
to
come
into
compliance
with
these
kinds
of
requirements.
To
have
sort
of
a
one
data
source
approach
to
this.
It
would
be
better
for
us
to
really
work
with
a
software
vendor
to
come
into
compliance
with
this,
like
our
Year
2000
compliance,
coming
and
making
sure
we
were
prepared
for
that.
For
example,
when
the
euro
currency
was
brought
upon
us
we
counted
on
our
software
vendors
to
help
us
get
there
and
really
didn't
have
to
do
too
much
with
internal
software
to
have
to
come
into
compliance.

That's
sort
of
what
we
would
keep
our
eye
on
if
this
rule
passed
and
we
had
to
come
into
compliance
with
these
kinds
of
requirements,
to
see
if
we
could
move
in
that
direction.

However,
I
don't
think
anybody
has
a
lock
on
this,
from
what
I
can
tell.

Mark
Duvall:
The
[
Federal
Drug
Administration]
has
a
web
site
relating
to
Part
11.
In
that
web
site
are
presentations
to
[
Federal
Drug
Administration]
by
a
variety
of
vendors.

These
vendors
promise
much.
They
have
lots
of
products
for
sale.
They
are
all
addressing
the
Part
11
requirements,
which
as
we
know
are
very
similar
to
the
CROMERRR
record­
keeping
requirements.
These
solutions
by
and
large
are
untested,

unproven.
They
would
need
to
be
validated.
They
would
need
to
140
be
validated
not
only
as
a
piece
of
software
available
for
sale,
but
more
significantly
perhaps
they
would
need
to
be
validated
within
each
user's
computing
environment.
For
adaptability,
compatibility
with
existing
systems;
for
integration
with
other
kinds
of
systems,
so
that
information
can
flow
freely
throughout
the
enterprise.

The
first
thing
to
be
said
is,
are
there
emerging
technologies?
Yes,
and
there
are
a
variety
of
companies
that
would
be
glad
to
sell
them
to
us.
But
one,
they
are
unproven;

two,
they're
very
expensive.
When
you
consider
the
wide
variety
of
electronic
records
being
kept
that
would
come
under
CROMERRR,
any
one
solution
will
be
inadequate
to
address
the
totality
of
the
problem.

For
example,
there
is
a
vendor
who
has
made
a
presentation
to
[
Federal
Drug
Administration]
claiming
that
they
can
attach
an
audit
trail
to
Microsoft
Excel.
Maybe
they
can.
Up
until
just
a
few
weeks
ago,
their
product
was
listed
as
being
under
development.
They
claim
it's
ready
or
almost
ready.
Maybe.

Maybe
it
is,
and
at
some
point
it
will
be,
presumably.
But
a
solution
that
works
for
Microsoft
Excel
doesn't
do
a
darn
thing
for
software
other
than
Excel.
When
Excel
files
are
integrated
with
other
information,
electronic
information,
the
fact
that
the
Excel
piece
has
an
audit
trail
on
it
doesn't
do
a
thing
for
all
the
other
pieces
of
the
complete
package
of
information
141
that
doesn't,
for
the
rest
of
it
doesn't
have
an
audit
trail.

So
system­
wide
solutions
are
what's
needed.
These
are
tremendously
expensive.
Dow
has
been
looking
at
these
systemwide
approaches
to
things,
has
been
pricing
them.
We
consider
that
it
would
cost
easily
between
$
50­
100
million
for
Dow
to
buy
a
system­
wide
approach,
assuming
it
would
work.
Those
costs
include
not
only
the
costs
of
the
vendor,
but
significantly
greater
costs
within
Dow
for
the
cost
of
validating
and
integrating
them
into
the
Dow
system.
Training
the
people
in
how
to
use
them.
In
addition,
storing
the
information.

If
you're
talking
about
audit
trails,
you're
talking
about
storing
meta
data,
potentially
for
many
years.
The
whole
idea
of
memory
is
you
store
as
little
as
possible
as
efficiently
as
possible.
If
we
have
to
store
electronic
records
longer
than
we
would
normally
choose
to
do
so,
and
we
have
to
store
meta
data
along
with
the
original
information,
then
our
storage
requirements
increase
by
a
large
degree.

So
I
think
the
bottom
line
is,
if
we
can
put
a
man
on
the
moon,
if
we
can
solve
the
Y2K
problem,
then
yes,
we
can
figure
out
as
a
society
a
technical
solution
to
archiving
electronic
data.
The
question
is,
is
it
appropriate
in
the
context
of
a
record­
keeping
statute,
a
record­
keeping
regulation,

promulgated
under
an
amendment
to
the
Paperwork
Reduction
Act,
142
to
impose
on
private
industry
the
immense
technical
problems
and
costs
associated
with
implementing
emerging,
possible,

untested
solutions.
My
response
is
no,
that's
not
an
appropriate
allocation
of
responsibility.

We
see
the
federal
government
itself
tackling
this
problem.
The
National
Archives
is
very
concerned
about
government
agencies
archiving
electronic
records
for
extended
periods
under
governmental
archiving
requirements.
The
government
agencies
have
not
yet
figured
out
a
satisfactory
solution.
They
have
much
better
resources,
the
United
States
government
has
better
resources
than
any
single
company
does.

Yet
each
company
would
individually
be
responsible
for
finding
an
acceptable
solution.

The
magnitude
of
the
technical
and
financial
challenge
for
industry
is
immense.
Is
the
problem
technically
capable
of
being
solved?
Of
course.
But
should
it
be
solved
by
industry
in
the
context
of
a
Paperwork
Reduction
Act
regulation?
No.

That's
the
wrong
place
for
this
problem
to
be
resolved.

Possibly
in
the
future,
as
new
technologies
have
been
developed
and
established
and
proven
and
found
to
be
efficient
and
effective,
then
it
might
well
be
a
good
idea
to
revisit
the
question
of
whether
long­
term
archival
electronically
is
an
appropriate
requirement
to
impose
on
industry.
But
not
until
then.
143
Howard
Krueger:
I'd
just
like
to
confirm
from
a
costimpact
standpoint
that
I
did
a
rough
assessment
for
Procter
&

Gamble.
Again,
we're
a
worldwide
company,
we
have
over
100,000
employees
with
about
half
and
half
international
and
U.
S.
We
have
thirty­
seven
plants
in
twenty­
four
states.
Just
using
the
EPA
numbers
of
$
40,000
per
site
per
system
to
acquire
a
compliance
system,
and
then
$
17,000
per
facility
per
year
to
keep
things
going,
and
that
was
just
manufacturing
facilities.

Then
added
to
that
all
the
records
and
compliance
documents
that
we
keep
for
[
Federal
Insecticide,
Fungicide
and
Rodenticide
Act]
and
[
Toxic
Substance
Control
Act]
products
that
we
make,
my
estimate
 
and
I
did
a
fairly
careful
analysis
and
I
had
a
number
of
people
contributing
to
this.
My
assessment
came
out
between
$
80­
100
million
for
our
company.

Just
setting
that
aside,
the
bigger
challenge
is
that
those
are
real
live
dollars
you've
got
to
come
up
with
and
there
is
no
one
budget
that
can
accommodate
that
kind
of
an
impact
in
even
a
three
to
five
year
period.
It's
kind
of
overwhelming
in
today's
environment.
So
given
the
current
requirements,
that's
for
a
large
multinational
company,
that's
what
you're
talking,
which
is
validated
by
the
comments
that
Mark
made.
I
hadn't
known
what
his
assessment
was
nor
did
he
know
what
mine
was
before
we
were
here
today.

Robin
Rorick:
Robin
Rorick
with
[
the
American
Petroleum
144
Institute]
API.
It's
not
just
the
system
cost
but
it's
also
sort
of
having
to
take
inventory
of
the
current
systems,
both
assessing
each
application
and
identifying
the
gaps
between
the
functionality
and
each
of
the
new
requirements.
Sort
of
closing
these
gaps
with
custom
system
code,
either
new
software
and/
or
add­
ons
to
the
existing
software.
Updating
each
of
the
integration
routines
for
applications
integrated
into
other
information.
Redeveloping
the
reports
and
the
records
in
accordance
with
changes
made
to
the
underlying
applications.

Updating
the
system
documentation
and
user
manuals.
Then
conducting
all
the
end­
user
training.
So
it's
not
just
the
system
costs
for
the
archiving
and
everything
else,
it's
all
the
other
associated
steps
and
the
costs
associated
with
that.

API
hired
a
contractor
to
take
a
look
and
do
a
technical
analysis
of
this,
and
came
out
with
a
study
that
we
will
append
to
our
written
comments
when
they're
submitted.
But
the
average
cost
per
facility
came
out
to
be
about
$
2
million.

That
was
for
a
facility
with
just
five
computer
system
applications
that
would
have
to
be
updated.
In
the
end,
when
they
looked
at
the
overall
cost
impact
on
the
oil
and
gas
industry,
they
compared
it
to
what
had
to
be
done
for
Y2K
compliance.
The
estimate
of
that
was
$
2
billion
for
the
oil
and
gas
industry.

Robin
Roberts:
Great.
I
would
just
recap
some
of
the
145
bigger
issues
I've
heard
here.
It
would
seem
to
be
there
are
a
lot
of
concerns
about
the
audit
trail
and
the
gap
between
the
current
technology
and
what
CROMERRR
is
asking
us
to
do.
The
issues
raised
by
archiving,
which
are
many
but
which
seem
to
be
characterized
mostly
by
rapid
obsolescence
of
the
technology,

the
cost
of
it,
the
efficiency
of
it
if
it
were
to
be
installed.

Some
concern
about
the
scope
of
the
rule
and
the
definition
of
terms
like
electronic
records
and
what
exactly
do
we
mean
by
electronic
record­
keeping
systems,
and
whether
the
time
periods
for
which
records
should
be
kept,
although
they
may
have
been
fine
in
the
paper
world,
do
those
apply
in
an
electronic
world
where
the
media
inherently
degrades
over
time.

That
goes
to
questions
of
migration
and
loss
of
data
integrity
over
different
generations,
how
do
you
migrate
legacy
systems.

There
also
seems
to
be
some
concerns
about
anti­
fraud,

that
if
we
should
have
a
workgroup
to
go
of
industry
and
EPA
to
look
at
these
programs
that
are
at
highest
risk
for
anti­
fraud.

Maybe
go
after
those
first,
especially
since
that
particular
aspect
of
the
rule
wouldn't
be
time­
sensitive
as
would
be
compliance
with
the
[
Government
Paperwork
Elimination
Act]

purpose
sections
of
it.

As
for
alternatives,
there
seems
to
some
concern
about
risk
analysis
of
the
records,
that
we
do
a
risk
analysis
to
146
find
out
where
an
appropriate
solution
may
lie,
the
notions
that
the
signature
legislation
with
a
few
adaptations
could
apply
also
to
EPA­
required
recommendations.
Then
again,
there
seems
to
be
strong
support
for
this
notion
of
a
workgroup
with
EPA
to
come
up
with
this
record­
keeping
issue
if
it's
decoupled
from
the
electronic
reporting
and
gone
at
in
a
more
deliberative
and
risk
analysis
type
of
environment,
where
the
enforcement
or
the
data
security
is
commensurate
with
the
risk
of
the
program.

I
would
like
to
turn
to
the
panelists
and
if
possible
have
them
recap
just
the
major
things
that
they
heard
or
respond
to
specific
questions
that
you
heard
or
comments
that
were
heard.

Joe
Retzer:
I
think
you
did
a
good
job
of
listing
a
lot
of
the
things
we
heard
today,
so
I
don't
need
to
repeat
those.

I
guess
I
just
want
to
thank
you
for
coming
and
providing
us
these
comments.
I
want
to
let
you
know
that
I
think
they've
been
very
thoughtful.
We
haven't
had
a
lot
of
[
inaudible]

maybe
inwardly
you've
been
shaking
your
fists,
but
outwardly
you
didn't.
At
least
the
tone
I
think
was
one
where
we
could
really
hear
what
you
were
saying
today
and
pay
attention
to
it.

Our
comment
period
continues
until
February
27,
so
please
get
your
written
comments
in
as
well.
We
also
have
another
public
meeting
in
two
weeks
in
Dallas.
Obviously
we're
going
to
give
very
serious
consideration
to
decoupling
the
record­
147
keeping
part
from
the
other,
or
looking
at
possibly
some
other
simpler
or
more
straightforward
kind
of
criteria,
as
well
as
looking
at
modification
of
the
ones
that
we
have
here.
So
we've
got
a
lot
of
options
in
front
of
us,
a
lot
of
good
ideas.

I
think
we
heard
a
new
idea
that
I
heard
today
was
trying
to
do
something
in
terms
of
looking
at
the
broader
recordkeeping
requirements
themselves.
That's
really
not
a
function
of
our
office
and
information
office,
as
opposed
to
the
programs
who
set
up
those
individual
record­
keeping
and
reporting
requirements
for
their
programs.
But
it
may
well
make
sense
to
try
and
take
a
look
at
these
broader
recordkeeping
requirements
in
terms
of
things
like
the
longevity
of
a
record­
keeping
requirement
that
might
have
been
set
some
time
ago.
For
example,
before
people
were
keeping
records
primarily
in
electronic
form.
So
that
may
be
something
we
would
want
to
take
a
look
at
as
well.

Charles
Reese:
My
only
comment
was,
we've
talked
about
these
workgroups
here.
What
are
your
plans
as
far
as
doing
some
actual
field
research
to
 
because
you've
asked
questions
about
what
types
of
electronic
files
and
what
types
of
records
that
we
here
use.
It
seems
to
me
that
there's
probably
some
recognition
to
the
fact
that
you
didn't
know
of
some
of
the
ways
that
we
conducted
our
business.
What
would
be
your
approach
to
actually
going
out
in
the
field
and
observing
what
148
actually
is
taking
place
on
a
ground
level,
to
see
how
people
really
are
using
these
records
and
to
verify
the
things
that
you've
heard
here
today?
What
approaches
you
may
take
prior
to
the
end
of
the
comment
period
or
after
that
comment
period.

Joe
Retzer:
I
guess
there's
two
things.
One
is
we
do
have
some
contractor
work
going
on
to
do
some
research
into
some
of
these
areas.
That
report
will
be
available
as
part
of
the
record,
part
of
the
docket
on
the
rule.
The
other
thing
is
I
guess
you
could
invite
us.
If
there's
something
locally,

some
idea
you
have
about
us
coming
to
see
how
you
keep
records
in
your
company,
please
invite
us.
We
have
limited
amount
of
time
during
the
rest
of
the
comment
period,
but
if
you've
got
an
idea
invite
us
and
if
we
can
arrange
something
we'll
do
it.

EPA,
Unidentified
Male
Speaker:
Let
me
add
a
couple
thoughts
to
that.
We
have
also
been
meeting
with
small
groups
of
industry
people.
We
have
plans
in
fact
to
hold
at
least
one
more
meeting.
As
Joe
was
saying,
time
is
relatively
short
between
now
and
the
end
of
February,
but
we
are
trying
to
have
smaller
group
discussions
to
the
extent
that
we
can,
to
help
us
sort
of
make
a
decision
about
what
the
next
step
should
be.
If
we
do
decide
to
decouple
the
two
parts
of
the
rule,
then
I
think
we
need
to
step
back
and
do
sort
of
a
longer
thinking
about
our
process.

Something
that
you
might
want
to
be
aware
of,
the
agency
149
has
from
time
to
time
used
what's
sometimes
referred
to
as
negotiated
rule­
making
under
the
Federal
Advisory
Committee
Act.
If
we
actually
constructed
a
process
where
we
worked
with
some
of
you,
your
colleagues,
as
a
workgroup
to
continue
the
rule­
making,
we'd
have
to
be
constituted
under
[
Federal
Advisory
Committee
Act].
There
are
certain
requirements
and
limitations.
So
that
will
 
if
we
think
about
that,
we'll
have
to
think
about
whether
or
not
we
could
cope
with
[
Federal
Advisory
Committee
Act]
requirements.
So
that's
just
a
constraint.

If
that
responds
to
your
question,
I
did
want
to
also
add
something
about
electronic
reporting,
which
sort
of
came
up
a
little
bit
from
time
to
time.
We
did
of
course
talk
about
electronic
reporting
at
the
two
public
meetings
that
we
had
in
late
October
and
early
November.
It's
just
because
of
time
and
resource
constraints,
it's
unlikely
that
we'll
be
able
to
schedule
another
public
meeting
to
talk
specifically
about
 
it's
[
inaudible]
we'll
be
able
to
schedule
another
public
meeting
before
the
end
of
the
comment
period,
period.
At
some
point
there's
so
much
we
can
do.

However,
I
guess
I
would
suggest
a
couple
things
and
I
really
urge
those
of
you
who
have
electronic
reporting
issues
to
follow
up
with
us
one
way
or
another.
Certainly,
the
most
avenue
right
now
I
think
for
your
expression
of
comments
and
150
concerns
is
to
put
them
into
your
written
comments
that
you
file,
as
part
of
the
comment
period.
As
with
all
the
issues
that
you
raised
today,
electronic
record­
keeping
[
inaudible]

electronic
reporting.
If
you
have
issues,
please
do
put
them
in
writing
and
get
them
to
us
by
February
27.

I
guess
the
second
thing
is
that,
again,
within
the
constraints
of
time,
I
am
certainly
prepared
to
try
to
meet
with
at
least
one
or
two
small
groups
of
people
if
they
want
to
constitute
themselves,
to
talk
about
issues
on
the
electronic
reporting
side.
That's
certainly
something
that
we
could
consider.

We
may
also
be
able
to
have
some
sort
of
ongoing
discussions
beyond
the
closed
public
comment
period,
although
I'll
have
to
check
with
the
lawyers
and
make
sure
that
we
don't
violate
anything
under
the
administrative
procedures
act.
But
there
probably
are
ways
to
continue
the
dialogue
at
some
point
or
another.
We
do
want
to
do
that
because
we
do
want
to
make
electronic
reporting,
we
do
want
to
try
to
push
that
part
of
the
rule
forward
even
if
we
do
end
up
decoupling
the
recordkeeping
side
of
it.

I
guess
the
only
other
thing
is
I
don't
have
my
slides
here
for
the
electronic
reporting
part,
but
as
you
think
about
what's
in
the
proposal
and
that
notice
of
proposed
rule­
making,

I
guess
I
would
urge
you
to
try
and
bear
in
mind
that
there's
151
sort
of
three
distinct
areas
in
a
way
that
deal
with
electronic
reporting.
As
you
comment,
try
to
make
clear
to
us
which
area
you're
really
concerned
with.
There
is
the
provisions,
I
think
they're
Subpart
B,
that
deal
with
electronic,
which
are
the
regulatory
requirements,
proposed
regulatory
requirements,
that
deal
with
electronic
reporting
directly
to
EPA.
They're
fairly
short
and
straightforward.
That's
Subpart
B.

Subpart
D,
I
think
I
have
that
right,
in
terms
of
what's
in
the
proposed
rule­
making
provisions,
is
the
much
more
robust
treatment
of
requirements
on
electronic
report
receiving
system.
These
are
requirements
that
are
primarily
imposed,
to
the
extent
they
are
imposed,
on
states
and
local
governments
who
want
to
implement
electronic
reporting.
They
do
have
some
implications,
obviously
because
some
of
you
read
between
the
lines
and
see
that,
they
have
some
implications
for
what
your
electronic
reporting
experience
will
be
like,
reporting
systems
that
meet
those
criteria,
particularly
the
criteria
that
address
the
signature
method,
the
requirement
for
some
sort
of
registration
process
and
the
signature
certification
scenario.

You
can
kind
of
look
through
those
criteria.
Although
they
don't
directly
apply
to
companies
reporting,
they
will
have
an
impact.

Where
you
will
see
the
greatest
example
of
that
impact,

where
I
suspect
probably
there
will
be
substantial
comments,
is
152
in
the
preamble
discussion
of
the
way
that
EPA
has
been
proposing
to
implement
electronic
reporting
through
the
central
exchange
system.
That
lays
out
the
conceptual
design
of
that
system
as
we
were
thinking
about
it
about
a
year
and
a
half
ago.
Mostly
that's
still
true,
but
we're
still
thinking
about
it.

One
of
the
things
that
will
influence
our
thinking,
of
course,
are
the
comments
that
we
get
on
what's
in
the
preamble.

Bear
in
mind
that
the
way
that
that
system
is
laid
out
in
the
preamble
is
one
but
only
one
of
many
possible
ways,
we
think,

of
satisfying
the
criteria
for
systems
in
Subpart
D.

It
may
very
well
be
that
the
comments,
which
we
will
be
very
interested
to
see
on
the
system
concept
may
or
may
not
have
much
effect
on
the
criteria
themselves.
They
may
or
may
not.
But
the
criteria
are
actually,
if
you
look
at
them,

considerably
more
flexible
than
a
reading
of
the
central
data
exchange
concept,
because
that's
going
to
be
a
concrete
thing
whereas
the
criteria
are
meant
to
be
somewhat
neutral.

So
I
guess
I
would
encourage
you
to
kind
of
keep
that
distinction
in
mind
as
you
express
your
concerns,
because
I
think
that
will
help
us
understand
how
best
to
interpret
what
your
concerns
are.

Robin
Roberts:
Are
there
any
concerns
about
electronic
reporting
that
maybe
quickly
someone
wants
to
mention?
153
Unidentified
Female
Speaker:
I
have
sort
of
an
unrelated
question,
I'm
thinking
now
as
a
wrapping
up.
At
the
beginning
of
the
day,
it
was
mentioned
that
all
of
the
remarks
made
here
today
would
be
made
available.
I
wonder
if
those
will
be
in
sort
of
transcript
or
summary
form,
when
they
might
be
made
available
and
will
be
provided
with
a
list
and
affiliation
of
the
attendees
here
today.

Robin
Roberts:
The
transcript
will
be
available,
it's
usually
a
two­
week
turnaround
time
on
that.
Also
a
list
of
those
that
attended,
I
can
have
that
available
soon.
Releasing
it
to
you
is
an
EPA
call.
The
formal
way
that
we
proceed
is
that
I
present
the
transcripts
and
the
attendance
list
to
EPA,

they
take
a
look
at
it
and
pass
it
on.

Evi
Huffer:
We
plan
to
make
that
information
available
to
the
public
in
the
docket.
We'll
put
in
the
summary
of
the
meeting
as
well
as
the
actual
transcript,
as
well
as
the
participants.
You'll
be
able
to
find
that
in
the
docket
in
about
three
or
four
weeks.

Unidentified
Speaker:
[
inaudible]

Unidentified
Male
Speaker:
It's
electronic.

Evi
Huffer:
It's
electronic
and
you
can
find
it
actually
on
our
web
site
at
epa.
gov/
cdx.

Robin
Roberts:
If
you
have
the
sheet
that
has
the
FRN
notice
on
it,
the
web
address
of
the
docket
is
on
it.
154
Unidentified
Male
Speaker:
I
was
looking
for
the
docket,

I
found
the
electronic
docket
for
the
number
of
comments
that
have
been
submitted
by
SQA
and
Dow
and
Mobil,
but
I
have
not
seen
the
transcript
from
either
one
of
the
October
or
November
meetings.
Are
they
out
there?
I
haven't
found
them.

Evi
Huffer:
They
evidently
haven't
been
put
on
our
web
site
yet.
They
should
be
and
hopefully
they
will
be
up
next
week.

Unidentified
Male
Speaker:
We'll
check.

Unidentified
Male
Speaker:
That's
one
part
of
the
reason
for
the
question
is,
from
the
earlier
meetings
we
haven't
seen
them
yet.

Unidentified
Female
Speaker:
Just
one
comment
on
the
record
on
the
reporting
requirements.
Would
you
please,
in
whatever
comes
out
finally,
make
it
more
clear
what
people
who
currently
report
to
EPA
need
to
do,
or
if
this
applies
how
it
applies,
and
what
they
need
to
do.
As
a
vendor,
you
know,

we're
just
trying
to
gear
up.
It
was
not
clear
this
go­
around
what
all
these
things
meant
and
what
we
should
start
doing,
if
anything.

Unidentified
Male
Speaker:
[
inaudible]
particular
programs
that
you're
aware
of
that
 
Evi
Huffer:
The
ones
we
deal
with
most
would
be
the
acid
rain,
Part
75,
and
NOX
budget.
Also
Part
60,
CEM
systems,
some
155
of
whom
report
to
states
and
most
report
of
course
just
federally.
Then
ambient
air
quality
requirements,
we
do
a
lot
of
that,
ozone
mapping
kind
of
stuff.
Any
of
those
I'd
be
most
interested
in,
mostly
it's
all
air
that
we
deal
with.

Robin
Roberts:
Last
thoughts,
parting
thoughts?
One
in
the
back
here.

Unidentified
Male
Speaker:
Just
again,
from
work
I've
been
doing
with
FERC,
Federal
Energy
Regulatory
Commission,

over
the
past
two
years
or
so,
they've
been
really
moving
aggressively
toward
electronic
reporting,
both
of
standardized
forms
that
utilities
have
to
submit
but
also
pleadings
in
individual
cases.
They
do
a
lot
of
judicial
determination­
type
work.
They're
moving
very
quickly
in
trying
to
accommodate
that.

The
message
we've
given
them,
they've
heard
it
and
it's
worked
quite
well,
is
for
reporting
allow
companies
to
keep
information
they
have
to
submit
to
EPA
or
states
and
so
forth
and
the
states
pass
along
to
EPA,
in
whatever
form
they
typically
keep
their
internal
information.
Whether
it's
Word,

WordPerfect,
Adobe,
a
variety
of
formats,
and
allow
that
to
be
sent
over
and
keep
it
as
simple
as
possible.

FERC's
got
it
now
so
you
can
do
pleadings
through
their
web
site
and
you
can
use
any
of
those
various
[
Microsoft]
Word
formats.
They
capture
it,
they
turn
it
into
an
Adobe
document
156
which
preserves
the
pagination
and
so
forth
so
it
becomes
a
fixed
document
for
the
public
record.
You
don't
have
to
go
through
a
lot
of
elaborate
signature
tracking
and
so
forth.
If
you
want
to
submit
something,
you
have
to
have
registered
in
the
sense
of
signing
on
through
the
web
site
as
who
am
I,
where
am
I
and
contact
information.
I'm
able
to
submit
stuff
for
my
boss,
general
counsel
of
our
association,
and
he's
also
registered
in
there.
And
that's
sort
of
the
end
of
it,
it's
a
five­
minute
process
once
you've
done
that
initial
background
work
and
it's
very
easy.

So
that
would
be
my
observation.
Electronic
reporting
can
have
lots
of
benefits,
both
in
terms
of
us
as
reporting
entities,
the
states
and
maybe
more
directly
dealing
with
EPA,

but
also
for
EPA
in
terms
of
managing
this
data.
So
just
simple,
simple,
simple
and
let
people
use
their
existing
software
systems,
is
my
suggestion.

Robin
Roberts:
Thank
you.
Any
statements
from
the
panelists
and
then
I
think
we'll
just
wrap
it
up.
Are
there
any
outstanding
questions?
I
guess
I'd
like
to
thank
you
all
for
coming.
This
is
a
road
show,
we'll
be
appearing
in
Dallas
January
31
as
well.

[
End
of
transcript]