Document ID: EPA-HQ-OEI-2003-0001-0259
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-09-20T04:00Z

1
RESOLVE
EPA­
Record
Keeping
Rule
1/
31/
02,
Irving,
TX
Tape
1
[
Side
A]

Robin
Roberts:
 
Reporting
and
Record­
keeping
Rule,
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
just
here
to
be
sure
that
we
honor
the
agenda,
that
we
stay
on
track,
and
on
time.

This
meeting
is
intended
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
E­
Records
Provision,
Subpart
C
of
the
proposed
rule.

However,
later
on
in
the
day,
toward
the
end,
there
will
be
an
opportunity
to
briefly
discuss
other
issues
related
to
the
proposed
rule.

The
proposed
rule
was
published
on
August
31
of
last
year,

the
formal
public
comment
period,
which
originally
ended
November
29,
has
been
extended
twice,
most
recently
until
February
27th
of
this
year.
Written
comments
must
be
submitted
to
the
docket
by
that
time.
Instructions
for
submitting
the
comments
are
included
in
the
preamble
of
the
rule,
which
there
2
is
a
copy
of
at
the
front
desk,
if
you
don't
have
it
with
you
now.

This
meeting
is
not
intended
in
lieu
of
formal,
written
comments,
nonetheless,
this
meeting
is
being
recorded
and
the
transcript
of
the
meeting,
as
well
as
a
list
of
the
participants,
will
be
published
to
the
docket
as
well.

There
were
two
public
meetings
earlier
this
winter,
on
October
29th
in
D.
C.
and
on
November
9
in
Chicago,
and
there
was
a
public
meeting
earlier
this
month,
on
the
17th,
in
D.
C.,
that,

like
this
one,
focused
specifically
on
the
electronic
recordkeeping
provisions
in
the
rule.

I
would
just
 
I
did
a
quick
count
on
how
many
people
came
from
out
of
state,
but
can
I
just
see
a
quick
show
of
hands
for
who
came
out
of
state
or
who
drove
a
long
way
to
get
here.

Great,
okay.

In
the
course
of
conversations
with
some
of
you
last
month,
it
became
clear
that
more
than
hearing
from
EPA
you
wanted
an
opportunity
to
engage
the
Agency
in
a
discussion
of
your
concerns
about
the
record­
keeping
provisions.
The
agenda
is
intended
to
meet
your
requests;
after
a
brief
presentation
by
EPA
on
several
of
the
topics
you
have
on
your
agenda,
you
will
have
an
opportunity
to
share
your
concerns
about
the
proposed
rule
with
EPA
panelists
during
a
discussion
period.
3
To
foster
the
discussion,
Jeff
and
I
will
have
two
wireless
mikes,
we'll
be
running
betwixt
and
between
you
to
be
sure
that
you
have
an
opportunity
to
speak.

When
you
do
have
a
comment
to
make,
please
raise
your
hand
and
we'll
bring
a
mike
to
you.
We'll
take
as
many
comments
as
the
discussion
period
and
the
agenda
allows.
When
you
do
speak,
make
sure
you
speak
clearly
so
that
we
can
get
your
voice
and
comments
on
the
tape
and
it
can
be
transcribed.
Also
I'd
like
to
make
sure
that
when
you
do
speak,
you
state
your
name
and
your
affiliation
for
the
record
as
well.

At
this
time,
let
me
just
turn
this
over
to
the
panel.

I'd
like
to
introduce
the
staff
from
the
EPA's
Office
of
Environmental
Information.
Joe
Retzer,
Director
of
the
Collection
Services
Division
and
Evi
Huffer,
Co­
Chair
of
the
Electronic
Reporting
and
Record­
keeping
Group,
and
on
phone,

and
on
cue,
David
Schwarz,
also .

David
Schwarz:
Am
I
on
loudspeaker?

Evi
Huffer:
Yes
you
are.
You
can
say
good
morning
to
everyone.

David
Schwarz:
Good
morning
everyone.

Robin
Roberts:
Alright,
great.
So
now
to
kick
off
today's
presentation
and
discussion,
I'll
just
turn
it
over
to
you,
Joe.
4
Joe
Retzer:
Okay.
I
wanted
to
first
of
all
thank
you
all
for
being
here
today,
we
have
been
working
with
states
and
various
industry
people
on
this
rule
for
a
very
long
time,
both
before
it
was
proposed,
and
then
several
discussions
since
that
time.

The
focus
of
today's
discussion
is
primarily
on
the
record­
keeping
provisions
of
the
rule,
which
is
where
we've
received
the
vast
majority
of
comments
to
this
point
and
the
vast
majority
of
people's
concerns
with
the
rule.
So
what
we
did,
after
kind
of
receiving
an
initial
round
of
comments
on
the
record­
keeping
portions,
was
to
extend
the
comment
period
so
that
we
could
address
some
of
those
questions
that
we
put
out
in
the
Federal
Register
notice
that
I
think
you
all
were
able
to
get
a
copy
of
when
you
came
in.
So
that's
kind
of
really
the
primary
focus
of
today,
to
basically
share
information
on
the
electronic
record­
keeping
provisions.

I
do
see
a
number
of
state
persons
here
today,
many
of
whom
we've
worked
with
before,
and
if
folks
want
to
get
into
those
kinds
of
questions,
on
the
electronic
reporting
or
the
state
approval
portion,
we
can
probably
do
that
around
the
end
of
the
day.
I
don't
know
if
we'll
exactly
follow
the
timing
on
this.
We
may
not
use
up
all
the
time
that's
on
the
agenda
for
the
earlier
pieces,
but
somewhere
around
near
the
end
of
the
5
day,
if
folks
want
to
address
those
issues,
we
can
do
that
as
well.

We're
here
recognizing
that
there
are
very
many
concerns
about
the
electronic
record­
keeping
portions
of
the
rule.
We
asked
in
our
Federal
Register
notice
whether
people
think
there
are
so
many
problems
that
we
need
to
just,
at
this
point,

separate
out
that
part
of
the
rule
and
put
it
on
a
different
time
schedule.
That
is,
go
back
and
take
a
look
at
that
and
re­
propose
that
part
at
some
other
time
in
the
future.
So
that's
one
of
the
questions
we
want
to
address
during
the
day.

So
we
know
there
are
some
major
issues
here,
we
understand
that,
and
want
to
hear
your
views
on
those.

Evi
Huffer
is
going
to
do
some
brief
presentations
to
kind
of
introduce
sections
of
the
discussion.
Evi
and
David
Schwarz,
our
person
on
the
speaker
phone
here,
were
the
Co­

Chairs
of
the
Work
Group.
I
guess
I
want
to
say
one
other
thing
here
about
this
rule
so
I
hope
you
will
understand
a
little
bit
where
we're
coming
from.

This
kind
of
rule
is
very
unusual
for
EPA
to
do.
We
are
representatives
of
EPA's
Office
of
Information,
but
we're
trying
to
put
out
a
rule
that
covers
regulations
that
cover
the
whole
Agency,
the
whole
range
of
programs.
So
rather
than
each
program
trying
to
address
its
own
electronic
reporting
and
6
record­
keeping
rule
relative
to
its
regulations,
we're
trying
to
do
one
global
one
that
addresses
the
whole
range
of
issues
across
the
Agency.
It
has
the
advantage
of
you
not
having
to
address
ten
or
twenty
or
however
many
programs
there
are,

different
rules,
and
different
approaches
to
reporting
and
electronic
record­
keeping.

The
idea
here
is
that
there
will
be
one
standard
EPA
approach
in
this
area.
What
it
also
means,
however,
is
that
the
proposal
that
you
have
in
front
of
you,
and
the
decisions
that
we're
eventually
going
to
make,
have
to
reflect
the
views
of
all
those
different
EPA
programs.
So
we're
here
speaking
for
the
water
program,
for
the
Enforcement
Office,
General
Counsel's
office
and
so
on,
around
the
Agency.

So
even
though
the
folks
in
front
of
you
today
are
from
the
Information
Office,
we're
taking
this
information
back,

including
the
transcript,
which
we'll
make
available,
as
well
as
all
the
comments
that
are
in
the
docket,
to
all
the
people
who
are
in
our
cross­
Agency
work
group
that
reflect
all
those
different
programs.
So
we're
trying
to
balance
those
program
interests,
our
interests
in
the
Information
Office,
which
are
information
efficiency
oriented
things,
and
balance
those
kind
of
things
with,
say,
for
example,
enforcement
concerns
from
other
parts
of
the
Agency.
7
I'll
turn
this
over
to
Evi
to
start
things.

Evi
Huffer:
Good
morning,
I'd
also
like
to
thank
you
for
joining
us
here
in
Irving,
Texas
today.
I
was
looking
forward
to
coming
to
Irving,
Texas
looking
as
forward
to
this
as
anyone
could
be,
in
large
part,
because
I
was
hoping
to
see
some
new
faces
out
there,
at
the
D.
C.
meetings
we've
had
the
same
participants
that
have
stepped
forward
to
the
mike
and
given
us
their
comments.
So
we
were
hoping
that
coming
to
this
part
of
the
country,
we
would
see
some
new
faces
and
hear
from
some
new
companies.
So
looking
around
the
room,
it
looks
like
we've
succeeded
in
that
respect.

I'm
going
to
take
a
few
minutes,
maybe
ten
minutes,

fifteen
minutes,
to
go
over
some
of
the
basic
provisions
for
electronic
record­
keeping.
At
our
last
D.
C.
meeting,
before
we
started,
I
was
at
the
back
getting
some
coffee,
and
as
Robin
was
convening
the
meeting,
I
heard
someone
at
the
table
looking
through
the
presentation
mumble,
"
This
is
the
same
old
stuff,

we've
heard
it
before."
Well,
you
probably
have
heard
most
of
it
before,
because
the
rule
hasn't
changed.
We're
still
in
the
public
 
as
Joe
and
Robin
have
said
 
we're
still
taking
public
comments
at
this
point.
No
decisions
have
been
made.
The
Agency
will
get
together
again,
as
Joe
pointed
out
there
is
a
work
group
process
for
writing
this
regulation
and
for
making
8
changes
to
this
regulation,
and
changes
will
not
be
made
until
all
of
the
comments
are
in.

So
with
that
said,
I'll
just
go
over
the
background,

electronic
reporting,
electronic
record­
keeping
under
the
rule,

and
then
talk
about
some
of
the
general
issues,
some
of
the
general
issues
that
have
come
up.

As
has
been
mentioned,
this
is
a
cross
media
rule.
It
encompasses
a
broad
range
of
report
and
record­
keeping
requirements.
It's
basically
under
more
than
ten
different
statutory
programs.
For
the
record­
keeping
provisions,
these
statutes
and
regulations
have
record
retention
periods
of
three,
five,
ten,
twenty,
in
some
cases
thirty
years
or
more.

Another
issue
that's
probably
unique
under
this
rule
is
that
EPA
may
be
the
first
federal
agency
to
deal
with
electronic
recording
and
record­
keeping
programs
involving
delegated
states.

Reporting
submissions,
under
EPA
programs,
go
primarily
to
states.
80
percent
of
those
reports
go
to
states.
Another
17
percent
go
to
local
governments
and
third
parties.
The
remaining
3
percent
EPA
collects
directly.
That's
still
about
400,000
reports
from
90,000
different
facilities.

Robin
has
already
pointed
out
that
we've
had
a
number
of
public
meetings;
we've
actually
had
extensive
stakeholder
9
consultation
in
writing
this
rule.
The
proposed
rule
was
published
on
August
31st
of
this
past
year,
and
we're
providing
180
day
public
comment
period.
That's
pretty
long,
standard
public
comment
period
is
generally
90
days.
This
extended
comment
period
was,
in
part,
due
to
early
comments
we
received
from
the
public,
asking
that
we
extend
the
comment
period.

We've
also
had
three
public
meetings.
This
is
the
fourth
and
final
public
meeting,
two
in
D.
C.,
one
in
Chicago,
and
this
one
here
in
Texas.
We've
had
one
state
meeting
in
D.
C.,
last
October,
we'll
be
having
another
one
in
D.
C.
prior
to
the
end
of
this
comment
meeting.
That
will
probably
be
at
the
end
of
February.

In
addition
to
these
public
meetings
that
we've
had
during
the
comment
period,
we
also
had
extensive
consultation
with
the
states
pre­
proposal,
before
we
ever
sat
down
at
EPA,
before
we
ever
convened
the
work
group
for
this
rule
and
wrote
this
rule,

we
met
with
a
group
of
states
that
were
sponsored
by
the
National
Governments
Association,
it
was
approximately
35
different
states
over
a
period
of
about
18
months,
to
identify
what
their
business
needs
were,
to
look
at
the
technologies
that
they
were
using
to
find
out
what
was
going
on
at
the
state
level.
10
We
also
had
two
pre­
proposal
public
meetings.

Unfortunately,
from
our
perspective,
a
lot
of
the
comments
that
we've
been
hearing
during
these
last
public
meetings,
during
the
public
comment
period,
were
not
brought
up
at
those
preproposal
meetings,
at
least
the
comments
regarding
the
electronic
record­
keeping
provisions
weren't,
so
we've
heard
a
lot
of
new
comments,
particularly
regarding
the
electronic
record­
keeping
provisions
during
this
public
comment
period.

We
do
have
copies
of
the
public
comment,
the
public
meeting
transcripts,
available
on
our
website.
Right
now
we
have
the
transcripts
from
the
first
two
public
meetings
available;
hopefully
next
week
we'll
get
the
transcript
from
the
third
meeting
up,
and
in
a
couple
of
weeks
we
should
have
the
transcripts
from
today's
meeting
up
on
the
website
as
well.

You
can
also
find
copies
of
the
public
comments
that
have
been
submitted
to
the
docket
on
our
website,
as
well
as
most
of
the
supporting
documentation
that
was
included
in
the
docket
for
the
rule.
As
Robin
stated,
the
public
comment
period
ends
February
27th.

Why
do
we
need
a
rule?
Given
the
Government
Paperwork
Elimination
Act
[
of
1988],
GPEA,
and
the
Electronic
Signatures
and
Global
[
in]
National
Commerce
Act,
E­
SIGN,
given
these
two
pieces
of
legislation,
we've
had
a
lot
of
companies,
a
number
11
of
companies
asking
us
during
these
meetings,
why
do
EPA
have
to
write
a
regulation?
Why
can't
we
just
rely
on
that
legislation?

Well
to
actually
offer
electronic
reporting
and
recordkeeping
under
[
the
Government
Paperwork
Elimination
Act],
EPA
has
to
provide
provisions
for
electronic
record­
keeping
and
reporting.
[
The
Government
Paperwork
Elimination
Act]
does
not
override
existing
statutes
and
regulations;
it
basically
provides,
encourages,
mandates
that
agencies
provide
the
option
of
electronic
reporting
and
record­
keeping
to
its
regulated
companies
by
the
year
2003.
I
think
it's
October
2003.
But
it
doesn't
tell
you
how
to
do
it
and
it
doesn't
override
the
existing
regulations.

[
The
Electronic
Signatures
and
Global
in
National
Commerce
Act]
regulation
was
primarily
aimed
at
commercial
transactions.

It
doesn't
affect
the
industry­
to­
federal
government
reporting
for
EPA,
that's
covered
under
[
the
Government
Paperwork
Elimination
Act].
For
the
most
part,
it
doesn't
affect
our
record­
keeping
requirements
either,
it
only
affects
recordkeeping
requirements
to
the
extent
that
the
documents
that
are
being
maintained
as
records
are
primarily,
first
and
foremost,

business
documents.
12
So
for
the
most
part,
[
the
Electronic
Signatures
and
Global
in
National
Commerce
Act]
doesn't
affect
EPA
programs,

and
[
the
Government
Paperwork
Elimination
Act]
mandates
that
we
provide
electronic
reporting
and
record­
keeping,
but
doesn't
override
our
existing
regulations
and
statues,
and
that
basically
forces
the
Agency
to
promulgate
regs
to
remove
existing
obstacles
to
electronic
reporting
and
record­
keeping
and
to
put
in
place
some
implementation
guidelines.

And
then
there
is
also
the
EPA
need
to
ensure
that
as
we
move
forward
with
electronic
reporting
and
record­
keeping,
that
we
maintain
a
legally
valid
compliance
program
for
our
environmental
regulations.
We
want
to
ensure
that
the
information
that
we
get,
that
we
have
access
to,
provides
us
the
legal
equivalent
of
the
same
information
in
a
paper
media.

Who
does
the
rule
apply
to?
The
rule
applies
to
regulated
companies
reporting
to
EPA.
It
also
applies
to
regulated
companies
reporting
to
delegated
states.
It
applies
to
regulated
companies
maintaining
compliance
records
under
EPA
regulations,
and
it
applies
to
states
that
are
implementing
EPA­
authorized,
approved
programs.

It
does
not
apply
to
state­
to­
EPA
reporting,
to
government­
to­
government
reporting.
EPA
is
working
closely
with
the
states,
and
we're
creating
what
we're
calling
the
13
state­
EPA
network.
It
also
doesn't
apply
to
mag­
based
media,

diskettes,
CDs,
tapes.

The
core
rule
provisions
were
intended,
as
I
mentioned,
to
remove
current
obstacles
in
our
regulations
to
electronic
reporting
and
record
keeping,
to
require
 
it
basically
requires,

in
the
realm
of
electronic
reports,
that
those
reports
be
submitted
to
EPA­
designated
systems
or
to
EPA­
approved
state
systems.
So
basically
the
rule
requires
that
for
reporting
from
industry
to
EPA
or
to
a
delegated
state,
that
the
reporter
use
the
specified
system.

It
also
sets
performance­
based
criteria
for
state
electronic
reporting
systems,
and
it
sets
function­
based
criteria
or
standards
for
electronic
records.
The
rule
ties
the
approval
of
state
systems
to
existing
EPA
predicate
regulations.
CROMERRR
doesn't
override
the
existing
predicate
regulations,
those
regulations
that
are
in
place,
and
most
of
those
regulations
have
an
approval
process
for
approving
state
programs
and
for
making
changes
to
those
state
programs.

Basically
the
CROMERRR
rule
would
create
a
new
part
under
40
CFR
Part
3,
and
it
consists
of
four
subparts:
Subpart
A
has
general
provisions,
lists
definitions,
Subpart
B
deals
with
electronic
reporting
to
EPA,
Subpart
C
deals
with
electronic
record­
keeping
requirements
for
industry
maintaining
records
14
under
EPA
programs,
and
that's
primarily
what
we're
here
today
to
talk
about,
and
Subpart
D
talks
about
the
electronic
reporting
and
record
keeping
under
EPA­
approved
state
delegated
programs.
Again,
we're
going
to
focus
on
Subpart
C,
but
there
will
be
time
to
focus
on
Subpart
B
or
Subpart
D
toward
the
end
of
the
day.

We'll
move
on
to
the
specific
electronic
record­
keeping
provision.
And
just
to
reiterate
what
our
goal
was
when
we
were
writing
this
rule
and
writing
this
Subpart
C,
for
industry,
we
wanted
to
provide
the
opportunity
for
industry
to
maintain
electronic
records
in
lieu
of
paper
records.
At
the
same
time,
we
wanted
to
ensure
that
any
electronic
records
maintained
by
regulated
entities
would
be
reliable
and
trustworthy
and
available
to
EPA
and
to
other
agencies
as
required
under
the
current
regulations.
So
those
were
our
goals
in
writing
the
rule
and
those
goals
haven't
changed.

We'll
move
on
to
the
record­
keeping
scope
and
approach.

Basically
the
scope
of
the
record­
keeping
provision
applies
to
all
record
keeping
by
regulated
entities
under
all
of
the
EPA
and
EPA­
authorized
state
programs.
The
rule
does
provide
for
exceptions,
however
at
this
point
no
exceptions
have
been
identified.
15
The
approach
that
we
took
was
function­
based
criteria
for
electronic
records,
we
basically
stipulated
criteria
that
we
felt
would
ensure
that
the
records
being
created
and
maintained
would
provide
for
integrity,
authenticity,
and
non­
repudiation.

In
writing
Subpart
C,
we
also
tried
to
be
consistent
with
existing
compliance
practices,
for
instance
the
Good
Laboratory
Practices,
EPA's
Good
Laboratory
Practices
under
[
the
Toxic
Substances
Control
Act]
and
[
the
Federal
Insecticide,

Fungicide,
and
Rodenticide
Act]
programs,
and
any
existing
electronic
record­
keeping
regulations
or
statutes.

The
one
that
was
looming
large
on
the
horizon
then
and
now
is
the
Food
and
Drug
Administration's
Electronic
Record
and
Signature
Rule
which
can
now,
I
believe
in
1997,
we
have
a
number
of
facilities
at
EPA
that
are
subject
to
both
EPA
and
[
Good
Laboratory
Practices]
regulations
under
[
the
Toxic
Substances
Control
Act]
and
[
the
Federal
Insecticide,

Fungicide,
and
Rodenticide
Act],
as
well
as
the
[
Food
and
Drug
Administration]
Part
11,
and
they
were
very
vocal
early
on,

particularly
during
the
pre­
proposal
period
when
we
had
the
public
meetings,
in
asking
us
to
make
sure
that
whatever
we
did
would
be
consistent
with
the
regulations
that
they
currently
have
to
comply
with
for
[
the
Food
and
Drug
Administration].
16
Before
I
go
over
these
general
provisions
for
electronic
record
keeping,
I
just
wanted
to
mention
that
in
writing
this
rule,
we
were
working
under
the
assumption
that
electronic
record
keeping
was
not
widely
occurring
within
industry
for
our
environmental
regulatory
requirements.
That
was
the
information
that
we
had
gotten
to
date.
We
knew
that
there
was
some
going
on
within
certain
programs,
but
by
and
large,
we
did
not
understand
the
extent
of
the
electronic
record
keeping,

those
records
that
were
being
maintained
electronically
by
facilities
at
the
time
we
wrote
the
rule.

So
one
of
the
general
provisions
for
electronic
record
keeping
is
that,
basically,
EPA
would
announce
when
it's
ready
to
allow
electronic
record
keeping
for
a
particular
requirement.
Well
this,
of
course,
is
problematic,
given
that
industry
has
stepped
forward
and
said,
"
Well,
we're
already
keeping
records.
Does
this
mean
we're
out
of
compliance?
Does
this
mean
once
the
rule's
promulgated,
do
we
have
to
comply
with
CROMERRR?"
It's
raised
a
number
of
issues.

So
clearly,
there's
a
problem
here
with
this
general
provision.
It's
been
brought
to
our
attention,
and
we'll
need
to
go
back
and
look
at
it
in
some
detail.
So
the
general
provision
that's
in
the
rule
now
that
says,
"
Okay,
when
EPA
is
ready
to
provide,
to
allow
companies
to
keep
electronic
records
17
for
this
particular
program,
we'll
announce
it
and
then
you
can
do
so."

And
the
other
general
provision
is
that
that
electronic
record
would
have
to
be
generated
and
maintained
by
an
electronic
record­
retention
system
that
meets
the
requirements
that
are
set
forward
in
the
rule
under
Subpart
C.

I
wanted
to
talk
a
little
bit
about
some
of
the
problems,

issues
that
have
been
brought
to
our
attention
during
this
public
comment
period.
One
involves
the
scope
of
the
rules,

and
that
the
scope
of
the
rule
is
tied
to
the
definition,
and
basically
the
definition
that
we
have
for
electronic
records,

and
the
way
it's
currently
written
which,
we've
been
told,

encompasses
everything
including
the
kitchen
sink.

And
the
other
is
the
definition
for
the
electronic
recordretention
system,
and
I've
just
put
them
in
here.
They're
included
in
the
presentation
if
you
want
to
go
back
and
focus
on
it,
and
also
the
definition
for
electronic
signature,
which
I,
again,
you've
probably
read
this,
we
can
go
back
to
it
if
we
need
to.

I'd
like
to
talk
a
little
bit
about
the
specific
criteria
in
Subpart
C;
3.100A
has
the
criteria
for
an
acceptable
electronic
record­
retention
system.
B
is
a
provision
that
basically
states
that
systems,
controls,
and
documentation
must
18
be
available
for
inspection
by
EPA
or
authorized
state
programs.
C
deals
with
electronic
signatures
and
provides
some
additional
provisions
that
electronic
signature
is
associated
with
electronic
records.

Actually,
I
thought
there
was
a
slide
in
here
that
went
through
the
basic
criteria,
but
I
don't
see
it,
but
there's
basically
nine
criteria.

David
Retzer:
It's
later
on,
I
think
we
deal
with
that
later
on.

Evi
Huffer:
Alright,
so
this
is
basically
just
an
overview
of
the
electronic
record­
keeping
provision.
We'll
go
into
the
specific
criteria
in
the
next
discussion.
Some
general
issues
that
have
been
brought
to
the
table
involve
current
practices
going
on
within
industries
vis­
à­
vis
electronic
record
keeping,
the
scope
of
the
rule,
the
voluntary
nature
of
the
rule,
and
then
I'm
sure
there
are
others
here
today
that
will
be
added.

One
issue
in
particular
is
the
current
electronic
record
keeping
and
some
of
the
questions
that
we
have.
If
companies
are
keeping
electronic
records,
do
current
electronic
records
satisfy
current
EPA
record­
keeping
requirements.
And
that's
basically
a
question
that's
been
raised
by
companies
to
EPA.

Another
question
that's
been
brought
up
is
can
companies
keep
19
current
electronic
records
and
do
they
satisfy
state
program
requirements?

Another
issue
that's
been
brought
up
is
how
will
CROMERRR
change
the
status
of
current
electronic
record­
keeping
practices
within
industry?

Dealing
with
the
scope
issue,
the
scope
of
CROMERRR,
given
the
definition,
CROMERRR
has
been
interpreted
to
apply
to
any
record
that
involves
a
computer
in
its
lifecycle,
basically
any
record
that
involves
a
computer
anywhere
in
the
lifecycle
of
that
record,
even
if
a
printout
is
generated,
and
that
printout
is
maintained
as
the
record.

The
intention
was
that
CROMERRR
would
apply
only
to
records
kept
in
the
electronic
record­
keeping
system.
Clearly
we're
going
to
have
to
go
back
and
look
at
that
definition
in
detail
and
it
will
undoubtedly
be
revised.

Another
issue
is
the
voluntary
nature
of
the
rule.
The
question
has
come
forth,
will
companies
be
able
to
choose
not
to
comply
with
the
CROMERRR
standards?
Our
intention
in
writing
this
rule
was
yes,
they
would
be
able
to
choose
not
to
comply
with
the
CROMERRR
standards,
because
they
would
be
able
to
enact
not
to
do
electronic
reporting,
not
to
do
electronic
record
keeping
if
they
so
choose.
But
again
the
perception
is
that,
given
the
definition
of
electronic
reporting,
choosing
to
20
do
electronic
record
keeping
means
choosing
not
to
use
computers
at
all.
Again,
the
broad
interpretation
of
the
definition
of
electronic
record
keeping,
and
also
the
fact
that
companies
are
keeping
records
electronically
right
now.

So
that's
basically
just
an
overview
of
the
general
provisions
within
the
rule.
We
can
clarify.
If
you
have
any
questions,
we
can
certainly
answer
your
questions.
We
certainly
want
to
hear
your
comments.
We
put
forth
some
questions
that
we
hoped
would
kind
of
structure
the
discussion
or
at
least
start
off
the
discussion.
The
discussion
isn't
limited
to
these
questions.

The
questions
that
we
put
forth
were:
What
kind
of
electronic
records
do
companies
currently
keep
to
satisfy
EPA
requirements?
How
prevalent
is
electronic
record
keeping
in
the
private
sector­­
right
now
when
it
comes
to
EPA
environmental
reports?
What
we've
heard
so
far
is
that
it's
very,
very
prevalent.
What
kinds
of
systems
are
being
used
to
keep
those
environmental
records?
And,
is
there
an
important
difference
between
the
storage
of
raw
data
and
other
data?
And
I
think
what
we've
heard
so
far,
there
definitely
is
a
very
distinct
difference
between
raw
data
and
records.
David,
did
you
want
to
add
anything?
21
David
Schwarz:
No,
I
don't
think
so,
I
think
you've
done
just
fine.

Evi
Huffer:
Okay.

Robin
Roberts:
Great,
then
this
is
your
opportunity
to
comment,
then,
on
scope.
And
also
I
would
just
like
to
encourage
you
to
be
mindful
of
the
other
discussion
areas
also
on
the
agenda
and
try
and
keep
any
questions
or
comments
that
you
may
have
narrowed
to
this
particular
agenda
topic,
which
is
the
scope
of
the
electronic
record
keeping.
Is
there
anyone
who
has
a
comment
that
they
would
like
to
make
to
start
off
the
discussion?

Please
identify
yourself
first.

Melvin
Swoboda:
This
is
Melvin
Swoboda
with
DuPont.
I
had
a
question
on
your
slide
on
the
voluntary.
You
indicated
that
we
could
choose
not
to
use
electronic
record
keeping.
How
do
you
choose
not
to
do
that,
what
is
your
perception
of
how
that
is
done?

Evi
Huffer:
Again,
the
assumption
when
we
wrote
this
rule
was
that
there
was
not
widespread
electronic
record
keeping
going
on
currently
within
the
industry
when
it
came
to
environmental
compliance
records.
We've
since
found
out
that
that
is
not
the
reality,
that
in
fact
electronic
records
are
being
kept.
So
the
rule
currently
requires
that
if
you
have
an
22
electronic
record,
that
you
comply
with
the
CROMERRR
criteria.

So
we
will
have
to
go
back
and
look
at
this
again.
But
the
intention
was
that
it
would
be
voluntary.

Robin
Roberts:
Other
questions?
Let's
stay
on
this
theme,
the
notion
of
voluntariness
or
how
do
you
choose
not
to
keep
electronic
records,
are
there
any
comments
on
that
or
any
others
that
you
may
have?

Bill
Yancey:
I'm
Bill
Yancey
with
BP,
based
in
our
office
right
outside
Chicago.
We've
been
developing
relational
databases
at
our
 
we
have
ten
petrochemical
plants,
five
refineries
and
3,200
service
stations.
And
we
have
been
developing
a
means
of
taking
data
from
previously
standalone
computer
systems.
These
principally
are
our
distributed
controlled
systems
and
our
laboratory
information
management
systems
where
we
keep
our
analytical
data.

We've
been
incorporating
these
databases
into
our
environmental
reporting,
which
by
default,
would
be
subject
to
the
current
standards,
as
I
understand
them.
And
right
now,

the
way
our
systems
have
been
developed,
they
would
not
be
in
compliance
with
the
CROMERRR
standards
with
any
of
the
recordkeeping
provisions.
So
I
strongly
urge
reconsideration
of
the
record­
keeping
part
of
this.
We've
been
doing
this
since
1981.

Thank
you.
23
Evi
Huffer:
Thank
you,
one
of
your
colleagues
brought
up
this
point
in
D.
C.
and
actually
submitted
a
document
to
us,
if
you
haven't
got
a
copy,
we'd
be
happy
to
share
it
with
you,
but
he
mentioned
the
number
of
standalone
systems
that
you
use
in
just
one
facility
alone,
the
number
of
users,
and
how
each
of
those
systems
operate
differently
and
the
fact
that
you're
trying
to
bring
them
together,
so
the
point's
been
made,
thank
you.

Terry
Salem:
This
Terry
Salem
from
the
TNRCC
and
I'd
like
to
follow
up
on
that
comment
and
ask
how
you
envision
this
rule­
making
coordinating
with
the
initiatives
to
encourage
EMS
systems
at
facilities
and
how
those
systems
are
incorporating
the
record
keeping
that's
already
on
site,
much
like
I'm
guessing
what
this
gentleman
was
just
talking
about,

incorporating
the
data
that's
already
been
gathered
into
those
systems
to
enhance
compliance
in
a
way
that
would
be
fruitful
for
everybody.

Evi
Huffer:
What
we've
learned
in
the
last
couple
of
months
is
that
this
issue,
providing
electronic
record­
keeping
provisions
for
our
environmental
records,
is
much
more
complex
than
we
initially
thought
it
was.
In
large
part,
it's
because
there's
a
lot
of
electronic
record
keeping
already
going
on
that
we
were
unaware
of.
In
large
part
it's
because
so
much
of
24
the
process
of
monitoring
for
the
environmental
realm
is
already
automated.
It's
basically
an
electronic
pulse
that
goes
to
a
machine.

And
we
certainly
wanted
to
encourage
electronic
record
keeping.
We
were
hoping
that
by
setting
criteria,
we
would
not
be
telling
companies
what
technology
they
needed
to
use,
that
we
would
allow
them
to
choose
the
technologies
that
work
best
for
their
facilities.
And
I
think
that's
still
our
goal.
We
would
like
to
write
a
rule
that
is
technology
neutral
and
that
certainly
encourages
electronic
record
keeping.

The
way
this
rule
is
written
it
clearly
has
problems,
and
it
affects
industry
systems
in
ways
that
we
had
not
anticipated,
and
we
will
have
to
go
back
and
re­
look
at
that.

David
do
you
want
to
add
anything?

David
Schwarz:
No,
no.

Evi
Huffer:
Okay,
just
pipe
up.

Joe
Retzer:
I
think
what
I'd
say,
Terry,
is
the
goal
here
was
to
sort
of
make
a
transition
from
the
existing
rules
on
the
books,
that
there
are
record­
keeping
rules
for
all
of
EPA's
programs,
was
to
make
a
transition
from
addressing
those
that
were
originally
designed
in
almost
all
cases
for
paper
and
saying
now,
if
we're
going
to
move
that
into
the
electronic
realm,
does
that
change
the
way
we
need
to
think
about
how
25
these
records
are
kept,
or
do
there
need
to
be
any
rules
about
it,
same
as
we're
doing
in
the
reporting
side.

On
the
reporting
side
there
are
certain
assumptions
that
were
built
into
the
original
regulations
for
reporting,
that
people
would
normally
put
them
in
the
mail,
that
if
there
were
a
signature,
they
would
normally
sign
it
or
sign
it
in
ink,
and
in
some
cases,
the
requirements,
actually
in
the
regs,
were
for
them
to
be
dated.
And
many
of
the
regulations
that
we
were
looking
at
used
the
words
"
paper"
or
"
paper
signature,"
or
"
ink
signature,"
or
things
like
that,
in
fact
we
found
thousands,

ten
thousand
plus
instances
in
the
EPA
regulations
where
there
were
specific
references
to
paper
or
signatures
on
paper,
those
kinds
of
things.

So
one
of
the
things
that
we
wanted
to
do
in
this
rule
was
basically
sort
of,
in
one
move,
rather
than
ten
thousand
moves,

was
kind
of
remove
all
that
paper
stuff
and
move
EPA
into
the
electronic
world.
And
in
the
reporting
side,
I
think
our
approach
is
going
to
make
sense
and
we
will
be
able
to
move
forward
addressing
most
of
the
comments
that
we've
gotten
pretty
well.

I
think
on
the
electronic
side,
the
issue
is
much
more
complicated
than
we
initially
assumed.
What
we
did,
basically
in
our
approach
here,
was
build
on
the
[
the
Food
and
Drug
26
Administration]
approach,
which
is
primarily
designed
for
laboratory
work
and
which
is
very
close
to
EPA's
own
[
Good
Laboratory
Practices]
regs.
And
the
problem
is
that
it
doesn't
address
many
other
kinds
of
electronic
reporting.

I
think
the
question
before
us
now
is,
if
we
take
EPA's
regulations,
the
record­
keeping
regs
that
are
still
primarily
designed
for
paper,
I
know
there
are
some
of
the
more
recent
regs
that
have
built
in
electronic
record
keeping,
but
historically
they're
still
sort
of
paper­
based,
and
say
if
we
move
them
to
the
electronic
arena,
there
are
really
sort
of
two
questions
for
us.
Is
there
anything
out
there
that
needs
a
regulatory
change
because
people
are
being
forced
to
keep
things
on
paper
where
it
doesn't
really
need
to
be?
And
that's
sort
of
the
basic,
underlying
premise
of
the
Government
Paperwork
Elimination
Act
that
all
federal
agencies
are
supposed
to
enable
electronic
record
keeping
where
their
current
rules
prevent
that.

And
there
was
[
the
Electronic
Signatures
and
Global
in
National
Commerce
Act]
legislation
that
was
passed
a
year
ago,

in
'
99,
which
provides
for
all
commercial
transactions,

provides
electronic
signatures
and
record
keeping
on
an
equivalent
basis
with
paper
by
just
providing
a
few,
for
record
keeping,
by
providing
a
few
criteria:
that
records
have
to
be
27
accessible,
they
have
to
be
accurate,
without
providing
a
lot
of
discussion
about
what
that
actually
means.
But
it
specifically
excludes,
that
Act,
it
specifically
excludes
record
keeping
and
reporting
required
by
federal
agencies.

So
that
was
something
that
was
sort
of
a
gap
that
was
left
over
by
that
legislation.
So
in
terms
of
thinking
about
EMSs,

I
guess,
for
example,
the
question
is,
do
current
recordkeeping
regulations,
if
you
just
assume
people
are
going
to
start
going
electronic
whatever
the
existing
regulations
say,

and
that
EPA
will
either
encourage
it
or
use
enforcement
discretion
by
saying,
you
know,
it
says
paper
but
we
know
people
are
doing
it
electronically,
so
we're
not
going
to
worry
about
that.
Is
there
anything
we
need
in
a
regulatory
fashion
to
make
that
transition?
Either
regulation
that
officially
acknowledges
that
electronic
reporting
is
okay,
or
are
there
some
other
kinds
of
criteria
that
we
need,
either
our
list
of
nine
or
some
other
list
that
might
be
appropriate.

So
that's
a
really
long
answer,
but
the
short
answer
to
your
question
is,
yes,
it
would
address
EMSs
and
electronic
record
keeping.
It
probably
needs
to,
but
whether
this
is
the
right
set
of
criteria
or
not?

David
Schwarz:
Joe,
a
couple
of
times
in
there
you
said
electronic
reporting
but
I
think
you
meant
record
keeping?
28
Joe
Retzer:
Okay,
yeah,
I
was
trying
to
talk
a
little
bit
about
the
parallel
between
reporting
and
record
keeping,
but
I
was
talking
about
record
keeping,
the
record
keeping
part
of
[
the
Electronic
Signatures
and
Global
in
National
Commerce
Act].

David
Schwarz:
That's
what
I
thought.

Don
Whaley:
This
is
Don
Whaley
with
Navajo
Refining
Company,
and
what
I
wanted
to
comment
on
kind
of
blows
[?]
what
you
asked
for
in
the
Federal
Register.
It
seems
like
there
are,
admittedly,
a
lot
of
misconceptions
that
this
rule
was
based
on,
and
it
seems
to
me
that
we
should
break
it
out
from
the
record
keeping
and
reporting
and
go
ahead
and
just
withdraw
the
rule
and
maybe
start
from
scratch.
I
think
it's
beyond
tweaking
at
this
point.

Nancy
Freshour:
I'm
Nancy
Freshour
with
Dow
Chemical,
and
going
back
to
what
the
gentleman
from
BP
mentioned,
that
they
have
these
integrated,
complex
systems,
and
of
course
we
use
similar
kinds
of
systems,
and
when
you
start
getting
into
these
systems,
the
definition
of
electronic
record
in
the
proposal
is
so
sweeping
that
in
many
cases,
especially
due
to
the
complexity
of
these
integrated
systems,
such
as
continuous
monitoring
systems,
a
real
clear
line
between
whether
it's
electronic
or
otherwise,
however
you
want
to
draw
the
line,
29
cannot
be
drawn
between
where
the
electronic
raw
data
generation
ends
and
the
reporting
begins.
So
that
is
a
real
critical
point
I
wanted
to
make.

In
addition,
I
want
to
bring
up
another
point
that
I
don't
think
has
been
brought
up
in
these
public
hearings
before,
but
we
use
a
lot
of
contract
suppliers
to
meet
our
record­
keeping
requirements.
These
suppliers
would
also
fall
under
these
record­
keeping
provisions.
Most
of
the
records
generated
by
these
contractors
are
generated
electronically,
however
currently
not
all
of
the
data
and
reports
from
these
suppliers
are
received
or
kept
electronically.
A
high
percentage
are
received
and
archived
as
hard
copies.

To
go
beyond
that,
we
have
been
investigating
additional
ways
to
receive
electronic
data
and
reports
from
these
contractors,
but
many
of
our
suppliers
do
not
have
the
capability
to
store
electronic
or
the
hard
copy
records,
for
that
matter,
for
certain
record­
keeping
requirements
required
by
the
EPA.
I'd
say
[
the
Resource
Conservation
and
Recovery
Act]
and
the
Sligo
[
phonetic]
Company,
they
typically
store
maybe
seven
years.
They
don't
have
those
capabilities.
How
are
we
going
to
deal
with
that?
We'd
have
to
migrate
their
data
and
store
it
because
we're
the
reporting
entity.
So
of
course,
every
time
the
data
is
migrated
electronically,
there's
30
a
chance
for
corruption
and
loss,
so
how
are
we
going
to
deal
with
these
situations?
And
I'd
like
to
touch
more
on
that
as
we
go
along
today.

[
End
side
A]

[
Side
B
begins
here]

Richard
Wiard:
My
name
is
Richard
Wiard
and
I'm
with
Process
Data
Control,
and
I
guess
as
an
issue
of
scope,
I'd
like
to
indicate
that
as
of
like
1986,
our
company
started
working.
It
was
founded
to
do
electronic
reporting
of
environmental
data.
And
I'd
like
to
almost
offer
the
possible,

or
my
assumption,
in
contrast
to
the
EPA
assumption,
that
I
couldn't
imagine
anybody
doing
the
emissions
inventory,
the
solid
waste
and
some
of
the
other
reporting,
who
in
some
way
doesn't,
if
we
consider
spreadsheets
as
a
computer
file,
who
wouldn't
be
involved
in
electronic
reporting.

So
I
would
lean
toward
100
percent
of
the
companies
are
probably
involved
in
electronic
data
storage,
record
keeping,

and
reporting,
at
least
as
the
basis
of
what's
coming
out
and
being
reported.

It
would
appear
to
me
that
this
is
very
far
reaching
and
that
the
record­
keeping
requirements
and
the
criteria
for
not
being
able
to
change
that
data
would
be
very
difficult
to
31
achieve
by
most
of
the
systems
that
I
know
are
in
place
right
now.

Pat
McFadden:
My
name
is
Pat
McFadden,
I'm
with
Gustafson,
and
we
do
work
submitted
to
the
EPA
in
support
of
[
unintelligible]
regulation,
{
Good
Laboratory
Procedures],
[
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act],
and
our
analytical
labs
have
been
collecting
electronic
data
for
ages.

We
have
all
sorts
of
things
that
HPLC,
GC,
pH
meters,
balances.

We
have
equipment
that
generates
electronic
data,
such
as
a
pH
meter,
but
has
no
way
to
store
that
data.
So
the
data
is
created
electronically,
which
the
rule
says
it
applies
to,
but
there's
no
way
to
maintain
that
data.
Once
you
read
your
pH
it's
gone,
the
display
is
cleared
and
that
data
is
gone.

And
I'd
like
to
know
how
the
regulations
will
apply
to
equipment
that
generates
electronic
data
but
doesn't
give
us
a
way
to
maintain
that
data
electronically.
And
also,
what
about
hybrid
systems
like
our
SOPs
are
created
using
electronic
systems,
but
then
they're
printed
out
and
signed
with
red
ink.

Will
CROMERRR
apply
to
those?
And
what
about
data
systems
like
HOBOS,
catalogers
that
record
temperature
and
humidity?

Those
electronic
signals
are
not
in
any
human
readable
form
until
you
download
the
information
from
the
data
logger
onto
your
Excel
spreadsheet,
and
then
it
becomes
human
readable,
but
32
the
electronic
signal
is
never
human
readable,
and
those
would
be
impossible
to
maintain
in
an
archive
system,
first
of
all
because
of
the
cost,
and
second
of
all
because
you'd
be
sitting
there
replacing
batteries
every
six
months
in
your
archives
to
keep
your
HOBOS
archived.

Joe
Retzer:
I
guess,
I
think
what
CROMERRR
would
apply
to
there
is
somewhat
ambiguous
depending
on
how
you
would
read
certain
pieces
of
it.
So
I'd
kind
of
like
to
turn
the
question
back
a
little
bit.
Since
we're
saying
we're
really
open
to
thinking
about
this,
I've
heard
a
couple
of
folks
talk
about,

the
Dow
person
also
said
this,
that
a
paper
requirement
for
record­
keeping,
whatever
the
program
is
going
to
be
relatively
specific
about
what
a
record
is,
I
believe,
at
least
we
haven't
heard
a
lot
of
people
telling
us
that
existing
 
maybe
you
want
to
tell
us
that,
but
that
hasn't
been
the
focus
of
our
discussions
that
existing
EPA
record­
keeping
requirements
are
so
fuzzy
that
you
don't
know
what
the
record
is.

But
when
you
move
into
electronics
area,
I
think
it
does
raise
some
issues
about
what
is
the
record
that
needs
to
be
kept?
If
you're
talking
about
a
data
system
that
takes
raw
data
somehow
generated
by
some
kind
of
analytical
tool
and
then
puts
it
into,
automatically
puts
it
into
a
spreadsheet
or
into
some
kind
of
analytical
software
program,
what
is
the
record?
33
If
there's
a
record
that
needs
to
be
kept
as
part
of
that
laboratory
analysis,
or
whether
it's
emissions
data,
what
is
the
record
that
should
be
kept,
that
you
would
want
to
keep
as
the
company's
official
record
for
your
purposes,
regardless
of
whatever
the
regulatory
agency
is
looking
for?

And
I
think
that's
part
of
the
problem
that
we
didn't
think
enough
about
as
we
initially
started
CROMERRR,
but
as
we're
learning
more
and
more
about
the
record­
keeping
part,
it
keeps
coming
up
to
us.
So
it's
a
question
that
I
wonder
how
you
would
answer
for
the
work
that
you're
doing.
If
you
were
saying
well,
here's
the
record
that
needs
to
be
kept,
where
would
you
draw
that
line?

Anybody?
And
so
what
tends
to
happen
is,
if
there's
not
a
bright
line,
then
people
say,
well,
keep
everything.

Robin
Roberts:
And
I
would
encourage
you,
just
from
an
implementation
of
view,
it's
good
to
hear
the
problems
that
you're
having
with
computer
systems
that
you
have,
the
problems
you
have
with
jiving
electronic
reality
with
regulations
that
don't
always
account
for
your
practices.

But
in
addition
to
that,
as
Joe
has
mentioned,
some
solutions
you
might
suggest.
You
have
these
dual
realities,

how
do
you
reconcile
it,
what
would
you
suggest?

Joe
Retzer:
Yeah,
it's
kind
of
a
scope
question.
34
Pat
McFadden:
Well
there
are
some
things
that
you
just
can't
do,
you
can't
save
a
pH
reading,
so
you
write
it
down,

that's
your
raw
data.
And
that
paper
becomes
your
raw
data
even
though
it
was
generated
electronically.

With
things
like
HPLC
data,
we
can
archive
a
copy
of
the
electronic
files
on
a
CD
and
put
that
in
the
file,
but
generally,
we
print
that
out
and
we
say
our
printout
is
our
raw
data
and
that's
what
we've
been
doing
for
years.

Recently
the
Office
of
Compliance
told
us
that
wasn't
correct,
that
we
had
to
save
electronic
files.

Evi
Huffer:
They
told
you
that?

Pat
McFadden:
Yes,
I
had
this
discussion
with
Frances
Leem
[
phonetic]
about
that
and
she
said
we
had
to
save
the
electronics.
And
so
for
[
Good
Laboratory
Practices]
we
are
now
saving
electronics
and
paper,
but
then
that
raises
the
whole
issue
of
migration
of
data
and
legacy
systems
and
all
things
that
we
really
don't
know
how
to
deal
with
at
this
point.

George
Britton:
George
Britton
with
Aventis
CropScience.

I'd
like
to
touch
on
both
the
idea
of
the
contractors,
using
the
small,
independent
contractor
who's
doing
this,
and
I
would
like
to
use
as
a
basis
for
discussion
a
real,
live
case
that
has
just
come
to
our
attention
as
of
three
days.
35
A
lab,
Horizon
Laboratories,
it
was
a
contract
analytical
laboratory,
we
got
a
letter
from
them
stating
that
they
were
going
out
of
business
as
of
the
4th
of
February
2002.
As
a
small
contracting
lab
with
nine
people,
they
said
they
were
going
to
put
their
facility
records,
which
the
[
Good
Laboratory
Practices]
says
the
sponsor
clients
have
to
have
access
to,
in
a
third­
party
archive
situation.

They
have
backed
up
their
electronic
data,
raw
data
in
our
case,
onto
magnetic
tape
and
will
stick
this
in
a
third­
party
holding
facility.
As
we
all
well
know,
magnetic
tape
will
degrade
in
integrity
over
time.
Because
some
of
their
instruments
are
sophisticated
equipment
like
mass
spec
devices,

which
require
very
sophisticated
software,
even
if
you
have
the
software
and
even
if
you
had
a
copy
of
the
electronic
records,

if
you
did
not
have
that
specific
platform
and
configuration,

you
would
not
be
able
to
re­
read
the
tape.

So
what
they've
supplied
to
us
as
sponsors
is
a
signed
printout.
Under
the
definition
as
proposed,
that
printout
is
just
a
presentation
of
the
information
and
now
the
raw
data.

So
now
you've
got
this
business
going
out
of
business
in
a
week,
how
do
we
even
treat
the
system
to
go
forward
through
time?
In
[
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
36
Act]
side
of
the
house
we
do,
in
fact,
use
a
lot
of
small
contractors,
one­
and
two­
man
operations.

Keeping
records,
under
the
proposed
definition
that's
there,
will
put
them
out
of
business.
They
will
not
be
able
to
keep
the
records
for
as
long
as
they're
in
business
because
from
the
[
Good
Laboratory
Practices],
the
facility,
they
have
to
keep
the
facility
records
for
as
long
as
they're
in
business.
And
if
they
choose
to
go
out
of
business,
because
of
confidential
business
information
laws,
each
of
their
clients
cannot
have
access
for
a
full
copy
of
their
records.
So
a
third
person
has
to
handle
that
information.

A
lot
of
their
indexes
and
databases
are,
in
fact,

electronic
spreadsheets
and
other
devices.
These
are
problems,

for
long­
term
retention,
as
companies
go
out
of
business.
And
not
allowing
for
transferring
of
media,
or
in
some
cases
printing
out
some
things,
really
makes
the
record
keeping
and
the
long­
term
archiving
section
next
to
impossible
to
comply
with.

Greg
Nutt:
I'm
Greg
Nutt
from
the
TNRCC.
I
have
kind
of
an
idea
about
that
bright
line.
I
think
the
issue
we're
getting
into
with
electronic
record
keeping
is,
that
since
there
is
no
line,
the
lawyers
want
to
keep
everything.
And
I
think
there
is
a
point
at
which
the
data
is
certified
as
37
accurate
and
correct.
You've
got
raw
data
from
distributive
control
systems
that
feed
into
systems
and
an
engineer
certifies
that
data
is
accurate
and
correct,
and
it's
submitted
to,
say
the
TNRCC
as
a
report,
deviation
reports
are
an
example,
missions
inventories
are
an
example.
That
should
be
the
point
at
which
these
documents
are
considered
to
be
electronic
records.
And
that
centralizes
the
record­
keeping
requirements
and
puts
them
on
the
TNRCC
or
the
state's
receiving
agency
in
a
lot
of
cases.

That's
a
lot
less
data
to
deal
with
than
dealing
with
all
the
data
that's
coming
out
of
these
distributed
control
systems,
all
the
data
that's
coming
out
of
them
and
these
laboratory
management
systems.

The
TNRCC
and
other
large
state
agencies
and
the
EPA
already
have
the
big
databases.
The
separation
between
the
operators
of
the
databases
and
the
operation
administrators,

and
are
taking
the
common,
kind
of
suit­
and­
tie
systems
analyst
approach
to
protecting
data,
and
I
think
that
meets
the
intent
of
the
record­
keeping
provisions
that
are
in
CROMERRR,
although
not
the
letter,
because
I
think
that
the
provisions
themselves
go
a
little
to
far
into
the
realm
of
things
that
are
just
not
possible
in
the
real
world.
38
But
I
do
think
that's,
at
least
for
the
purpose
of
CROMERRR,
it
might
make
sense
to
draw
the
line
as
when
the
records
are
submitted,
when
the
records
are
certified
as
accurate
and
correct.
And
not
try
and
get
into
all
the
information
that
feeds
into
those.
And
put
the
responsibility
 
and
the
culpability
 
for
the
accuracy
of
those
records
upon
the
individual
who
certifies
them
as
correct
when
they
come
in?

Joe
Retzer:
Is
this
just
applying
to
records
that
have
to
be
submitted?
What
about
records,
you
know,
a
lot
of
recordkeeping
requirements
just
require
people
to
keep
records
on
site,
not
actually
send
them
into
the
agencies.

Greg
Nutt:
I
think
in
most
cases
those
records
are
going
to
be
reviewed
by
somebody
on
site,
because
you
can't
just
take
what's
coming
out
of
your
distributive
control
systems
as
fact,

right,
because
there
are
instrumentation
issues.

Joe
Retzer:
So
certified
by
somebody,
whether
it's
mailed
in
or
just
kept.

Greg
Nutt:
Right.
And
that's
an
option
to
get
away
from
some
of
these
issues
with
distributive
control
systems,
data
coming
in
from
contractors,
put
the
responsibility
on
the
environmental
professionals
and
the
engineering
staff
at
the
plants
and
at
the
state
agencies
to
make
sure
that
those
records
are
kept
accurately.
39
That
would
get
us
out
of
a
lot
of
the
issues
of
record
keeping
in
CROMERRR.
I'm
concerned
about
some
of
the
talk
I'm
hearing,
saying
well,
we'll
just
take
record
keeping
out
of
CROMERRR
and
CROMERRR
will
be
fine.
And
that's
not
the
case,

there's
a
lot
of
problems
with
the
electronic
reporting
aspects
of
CROMERRR
as
well,
but
in
the
interest
of
keeping
to
the
schedule
I'll
save
that
for
later.

Robin
Roberts:
I
just
want
to
follow
up.
Are
you
suggesting
that
upon
certification
the
record
be
kept
electronically
or
printed
out?
How
would
you
keep
it
totally
electronic?

Greg
Nutt:
I
think
that
if
it
has
to
be
kept
forever,

you're
not
going
to
try
to
keep
it
electronically.
You're
going
to
micro
fiche
it
or
you're
going
to
store
it
as
paper
because
there
is
not
technology
for
keeping
electronic
records
forever.

Robin
Roberts:
So
there's
no
discomfort
with
the
ambiguity
of
printing
out
on
paper
electronically
generated
data?
Because
you're
comfortable
with
the
notion
that
paper
is
the
only
way
to
address
archiving
electronic
data?

Bill
Yancey:
I'm
Bill
Yancey
with
BP.
To
further
comment
on
Greg's
comment
about
certifying
the
data
that's
reported
to
the
best
of
our
knowledge,
we
have
situations
out
in
the
west
40
coast
where
we
are
measuring
rainfall
via
the
National
Weather
Service.
So
we
take
the
rainfall
and
report
it
on
a
monthly
basis
to
grab
the
storm
water
discharges.
And
we
have
no
choice
but
to
certify
that
data
as
being
the
best,
to
our
knowledge,
that
it
has
been
collected
with
a
legitimate
process.
Now
I
have
full
faith
in
the
National
Weather
Service,
but
I
don't
know
if
their
data
systems
would
meet
the
CROMERRR
requirements.
Thank
you.

Robin
Roberts:
Another
ground
rule
is
no
institutional
attacks,
please.

Mel
Swoboda:
This
is
Mel
Swoboda
with
DuPont.
I
guess
one
of
the
things
that
we
struggle
with,
and
like
the
gentleman
mentioned
about
the
laboratory,
right
now
I'm
dealing
with
the
migration
of
data
from
computer
systems
that
are
ten
years
old,

that
I'm
going
to
have
a
very,
very
difficult
time
doing
the
migration.
And
I'm
hoping
to
get
a
call
to
give
you
an
idea
of
how
much
it's
going
to
cost
me
to
do
that.

And
we
talk
about
distributive
control
systems,
but
in
reality
the
distributive
control
system
is
not
the
final
system
that
we
actually
have
the
data
stored
in.
For
us
our
distributive
control
systems
may
only
look
at
about
five
to
seven
days'
worth
of
data.
They
are
looking
at
very
intense
data
searches,
the
data
is
then
taken
to
some
sort
of
an
41
archival
computer
where
some
sort
of
evaluation
is
made
on
what
data
points
will
be
archived.

A
number
of
years
ago,
through
the
TNRCC
and
the
UIC
program,
we
worked
with
them,
with
TCC,
the
Chemical
Council,

as
well
as
individual
companies,
dealing
with,
how
do
we
handle
that
data?
How
do
we
get
the
archival
data
in
a
format?
And
we
went
through
a
process
with
them
to
really
establish
some
protocols
on
how
that
data
should
be
stored,
or
what
data
should
be
stored.

And
the
other
part
of
that,
though,
is
that
there
is
always
a
perception,
and
the
perception
that
you
got
when
you
read
CROMERRR
was
that
data
is
manipulated
and
people
modify
data
all
the
time.
I
think
it's
really
clear
that
you
need
to
understand
that
we're
looking
at,
in
one
system,
I
may
be
looking
at
seven
or
eight
points
of
a
thousand
points
that
it's
looking
at
in
process
control.

For
me
to
get
into
that
data,
is
absurd,
one.
I
mean
I
just
don't
have
the
need
to
get
into
it.
And
there
are
not
many
people
who
even
know
how
to
get
into
it,
it's
not
something,
a
format
that
you
can
do
very
easily,
you
are
really
going
to
have
to
work
it
through.

So
I
think
a
lot
of
the
security
that
you
talk
about
in
your
data,
I
think
common,
electronic
practices
on
how
they
42
store
data,
they
address
that,
it's
in
their
system,
the
IS
people
deal
with
that
situation
all
the
time
in
trying
to
keep
the
integrity
of
their
data.
It's
how
we
handle
the
data
after
that.
If
I
have
something
wrong
with
that
data,
how
do
I
document
that
there's
something
wrong
with
that
data?

I
have
a
data
point
that
I've
kept
on
a
continuous
monitoring
on
a
regular
southpaw
that
I
have.
One
of
the
things
I
struggled
with,
and
we're
talking
back
in
the
early
80'
s,
was,
okay,
when
I
lose
data
or
something's
wrong
with
that
data
and
I
don't
get
a
representative
sample
of
what
my
total
for
the
day
is,
how
do
I
make
that
change
in
that
data?

And
at
that
point
what
I
did,
and
I
still
do
today,
is
that
we
write
some
sort
of
a
document:
here's
what
the
data
was,

here's
why
it
changed
and
here's
what
I
did
to
change
it.
And
then
it
goes
into,
essentially,
my
monthly
report
for
that
modification
of
that
data,
there's
some
sort
of
documentation.

It
doesn't
necessarily
mean
that
I
have
somebody
saying
here's
a
signature.
But
that's
a
very
small
piece
of
it.
But
I
think
it's
one
of
those
things
that's
going
to
be
ongoing,

it's
difficult
to
do,
it's
kind
of
hard
with
some
of
this
data
to
really
get
the
things
that
you
require.

Joe
Retzer:
And
again,
this
is
maybe
getting
a
little
bit
ahead.
What
you
were
suggesting
is
your
process
for
43
documenting
changes
in
the
day.
That
rang
off
the
audit
trail
provision
in
our
thing
to
me.
Where
if
you're
keeping
paper
data,
then
presumably
you'd
put
in
a
piece
of
paper
along
with
that
data
that
said,
"
We
made
these
changes
on
this
date
for
such­
and­
such
reason,"
and
somebody
would
sign
it.

The
question
is,
well,
if
you've
just
got
electronic
spreadsheets
and
you
decide
to
change
the
numbers,
somebody
just
goes
and
changes
the
numbers.
Then
there's
no
record
of
who
changed
it
or
when
and
those
kinds
of
things,
unless
you
have
some
kind
of
paper
or
some
other
kind
of
documentation
control
system,
whether
it's
built
into
the
software
or
not,

some
way
of
acknowledging
those
kinds
of
changes.

Robin
Roberts:
Any
thoughts
on
how
you
might
want
to
decide
what
piece
of
a
data
screen
is
worth
being
archived?

Jim
McFarland:
Jim
McFarland,
I'm
with
the
IR4
Project
in
the
west.
We
do
pesticide
registration
work,
obviously.
[
Good
Laboratory
Practices]
is
for
us,
the
most
recent
discussion,

maybe
what
is
to
be
allowed.
It
seems
to
me
that
the
CROMERRR
rule
either
puts
you
in
one
category
or
the
other,
as
it's
written
right
now.
Either
you're
electronic,
or
you're
not.

Well,
the
reality
is,
at
least
in
our
program,
we're
sort
of
electronic
and
we're
sort
of
not.
The
[
Good
Laboratory
Practices]
regulations
don't
make
this
distinction
as
A
or
B,
44
we're
sort
of
AB,
and
in
order
to
address
the
practicalities,

the
spreadsheet
example
that
you
used,
if
you
don't
have
the
capabilities
to
have
this
audit
trail
in
your
electronic
data,

allow
the
use
of
a
printout
that
says,
"
this
is
what
the
original
was,"
and
the
associated
written
documentation
of
"
this
is
what
we
changed
it
to,
this
is
why
we
changed
it,

here's
the
new
printout."

For
us
we're
mandated
to
be
at
land
grant
universities;

they're
small
operations.
This
whole
electronic
record
keeping
thing
is
a
nightmare
and
not
possible.
It
could
put
us
out
of
business
in
large
part.

We
still
have
to
fight
the
fight
with
Frances
over
what's
the
original
data.
To
me,
that's
not
real
clear
in
the
existing
[
Good
Laboratory
Practices]
regulations.
The
fact
that
CROMERRR
doesn't
override
the
[
Good
Laboratory
Practices],

that
doesn't
solve
that
problem.
CROMERRR
has
the
potential
to
add
a
whole
bunch
of
stuff
to
[
Good
Laboratory
Practices]
that
we
don't
even
have
to
deal
with
right
now.
But
maybe
this
hybrid
system,
paper
and
electronics,
is
what
should
be
the
rule
as
opposed
to
A
or
B.

Evi
Huffer:
David?

David
Schwarz:
Yes?
45
Evi
Huffer:
Could
you
put
your
mute
button
on
when
you're
not
talking
to
us.

David
Schwarz:
Sure.

Robin
Roberts:
Is
it
true,
then
that
electronic
archiving
seems
to
be
the
reality
in
the
corporate
world?
There
are
no
success
stories,
no
stories
to
be
heard
about
some
innovative
software
that's
been
written
that
maintains
records,
precise
records
of
relevant
data
points
and
huge
data
streams?

Unidentified
Male
Speaker:
This
gets
back
to
 
there
are
record
management
systems
out
there
that
keep
generally
the
document
side
of
the
house.
Documentary
is
just
one
type
of
program.
There's
a
whole
bunch
of
them.

There's
another
whole
professional
group
that
doesn't
even
know
we
exist,
and
that's
called
the
Records
Management
Association,
better
known
as
ARMA,
where
they
have
certification
programs
for
record
keeping
professionals.
This
involves
everything
from
your
state
archives
to
business
records,
to
lawyers,
secretaries
who
keep
records
of
all
kinds
including
electronic.
And
even
they
are
struggling
with
the
idea
of
keeping
records,
both
from
a
historical
point
of
view,

the
historically
important
documents
in
a
format
that
you
can
read
them,
to
the
electronic
records.
And
they
are
struggling
with
that
whole
issue,
whether
to
keep
it
electronic.
46
Whether
to
retain
the
only
two
medium
that
the
U.
S.

Archives
acknowledges
today,
paper
and
microfilm,
they
are
the
two
only
archive
medium
that
are
accepted.
How
do
you
keep
stuff
available,
information
available.
It's
really
information
management,
not
so
much
record
management.
But
they're
struggling
with
this
whole
issue.
How
do
you
keep
it?

How
long
do
you
keep
it?
When
do
you
destroy
it?

One
of
the
current
cases
right
now
with
Enron
is
about
standard
record­
keeping
policies.
What
is
the
risk
of
the
record?
Certain
things
you
will
only
keep
a
few
days,
some
things
you
keep
a
few
months,
some
things
you
will
keep
for
years.
In
order
to
have
a
full,
corporate­
wide
system,
you
have
to
have
a
records
information
management
process
in
place.

The
bigger
companies
have
such
semblances
of
things,
but
they
don't
always
have
the
record,
all
the
criteria
has
been
laid
out
in
the
rules,
but
this
is
an
ongoing
thing
that
affects
not
just
manufacturing
facilities.
It's
affecting
every
library,

every
state
archive,
every
business
that
has
information
they're
required
to
keep
long
term.

No,
there's
no
one
piece
of
software
that
will
be
the
bullet
for
everything.
If
you
take
raw
data,
which
is
required
by
some
of
the
programs,
and
keep
it
moving
forward
over
time,

there's
no
one
piece.
You
can
do
things
with
electronic
47
records,
you
can
do
things
with
data,
you
can
do
compromises
in
between,
but
there's
not
anything
out
there
that
keeps
things
going
long
term.
With
the
archiving
part,
maintaining
functionality
of
software
is
the
real
hang­
up
for
electronic
records.

If
you
say
I
can
capture
the
output
of
the
device
and
transfer
it
to
some
long­
term
storage
format,
whether
it's
imaging
to
CDs
or
whether
you're
imaging
to
microfilm,
which
is
a
snapshot
of
that
record
at
that
time,
is
one
issue.
But
say
I
have
to
keep
whatever
generated
it
for
as
long
as
records
are
required
by
all
parts
of
the
EPA's
programs,
there's
nothing
out
there
that
will
do
it.
Keeping
information
is
one
side
of
the
house,
keeping
functionality
is
impossible.

Robin
Roberts:
Any
comments
on
that,
from
the
panel
or
from
the
audience
here?

Richard
Wiard:
Richard
Wiard
again,
I
do
believe
that
there
is
going
to
have
to
be,
as
Greg
mentioned,
as
I've
heard
mentioned,
a
division
or
point
in
time.
It
says
on
one
side
of
this,
it's
the
submitted
data,
on
the
other
side
is
data
that
does
not
need
to
match
these
record­
keeping
requirements.

One
challenge
that
is
going
to
come,
however,
with
such
things
as
Title
V,
is
that
you're
acknowledging
monitoring.

You're
acknowledging
that
you're
going
to
record
keep.
Well
48
those
then
place
on
the
"
we
will
maintain
side,"
things
that
might
otherwise
not
fit
into
the
quote,
unquote
"
submitted
category,"
which
I
would
think
have
to
be
a
part
of
these
record­
keeping
rules.

That's
sort
of,
I
guess,
in
a
way,
the
positive
aspect,

but
I
don't
know
if
the
word
submitted
is
going
to
be
able
to
be
the
divisor
or
the
criteria.
It
appears
that
we're
going
to
have
to
find
something
that
says
this
is
an
official 
I
was
thinking
the
other
day
that
I
would
hate
to
have
to
have
somebody
read
every
draft
of
a
letter
that
I
put
together
to
send
to
somebody
and
then
interpret
all
of
my
thoughts
that
weren't
as
good
as
other
thoughts
or
a
way
I
wouldn't
have
said
it,
but
this
could
very
well
happen
in
a
system
that's
capturing
every
aspect
of
the
data
as
you
evolve
it
toward
your
submittal
or
your
gathering.

And
that
to
me
would
seem,
in
data,
to
produce
the
same
kind
of
negative
or,
perhaps,
the
same
kind
of
negative
conclusions
that
multiple
drafts
of
your
pre­
letter
might
do
in
a
word
processing
system,
if
we
were
to
take
that
analogy.

So
I
think
this
is
going
to
be
very
challenging
to
find
a
middle
ground
or
a
ground
that
puts
one
thing
on
one
side
and
one
thing
on
the
other.
49
Just
one
more
comment,
in
regard
to
emissions
inventory,

which
we're
pretty
familiar
with.
The
level
of
calculations
and
details
that
are
involved,
companies
would
certainly
look,

I
believe,
to
have
someone
verify
the
calculations,
but
there
would
be
some
hesitancy
to
begin
to
get
back
to
every
chemical
balance,
every
this,
every
that,
because
you
could
then
figure
out
how
to
do
what
those
companies
are
doing.
So
there's
a
part
of
that
line
where,
I
believe,
there
is
going
to
be
confidentiality
issues
where
it's
more
than
just
the
feasibility
of
record
keeping,
where
it's
going
to
be.
This
is
my
business.
We
have
formulas.
How
would
we
go
to
Coca­
Cola
and
reach
far
enough
down
and
figure
out
how
to
make
Coca­
Cola,

if
you
take
this
to
one
extreme?

Robin
Roberts:
Maybe
we
can
go
on
to
the
next
part
of
the
discussion
unless
I've
overlooked
someone
who
has
a
word
to
say
here?
Move
on
to
a
discussion
about
the
general
criteria
and
overview,
and
then
take
questions,
and
break
for
lunch
after
that.

Joe
Retzer:
There's
one
more
question.

Unidentified
Female
Speaker:
I
guess
my
question
is,
what
is
this
going
to
provide
that
we
don't
already
have
flexibility
to
do
now?
And
is
it
going
to
restrict
us
to
certain
available
technologies
and
keep
us
from
doing
what
we
do
now?
I
think
50
the
intent
was,
we
want
to
allow
electronic
record
keeping,
but
we
don't
want
to
restrict
you
on
what
you're
going
to
be
able
to
do,
how
you're
going
to
be
able
to
do
it,
we
don't
want
to
dictate
what
systems
you
use
and
how
you're
going
to
do
it.

But
this
definition
is
so
wide­
sweeping
and
the
criteria
are
so
extensive,
basically,
we're
virtually
going
to
be
CROMERRR­
focused.
We're
not
going
to
be
saying,
how
sensitive
is
this
instrument?
Can
I
get
the
most
sensitive,
accurate
data,
you
know,
is
the
interface
user­
friendly?
Is
the
cost
of
maintenance
reasonable,
in
other
words,
is
it
CROMERRRcompliant
And
I
don't
know
if
that's
where
we
want
to
be.
I
don't
think
that
was
the
intent
and
I
think
that's
where
it's
driving.

Chris
Marlia:
Hi,
I'm
Chris
Marlia
and
I'm
with
South
Coast
[
Air
Quality
Management
District],
a
local
air
quality
regulatory
agency
in
Los
Angeles.
I'd
like
to
share
some
of
our
experiences
with
what
she
said.
We
have
a
SIP­
approved
rule
that
mandates
electronic
reporting,
and
it's
on
the
books
now
and
it's
approved
by
EPA,
and
the
only
way
we
were
able
to
get
that
rule
adopted
was,
the
facilities
that
we
regulate
wanted
this
rule
in
place.
And
yet
in
order
to
get
this
rule
in
place,
it
required
that
we
put
a
lot
of
record
keeping
and
record­
reporting
requirements
on
them.
They
were
willing
to
51
negotiate
with
us
and
come
up
with
some
requirements
that
we
both
could
live
with,
and
we
reached
a
consensus
as
to
what
would
be
those
record­
keeping
and
reporting
requirements,

because
they
wanted
the
end
result
of
the
rule,
which
was
a
market­
based
trading
program.

Yet,
if
there
wasn't
something
at
the
end
of
the
line
that
they
could
see
would
benefit
them,
we
probably
wouldn't
have
been
able
to
adopt
that
rule.

Joe
Retzer:
Were
the
record­
keeping
requirements
you
negotiated
with
those
companies,
were
they
about
the
content
of
the
records
they
had
to
keep,
or
did
they
also
include
criteria
for
how
the
electronic
records,
you
know,
whether
it's
this
set,
or
some
other
thing
like
making
them
sensible
and
those
kinds
of
things?

Chris
Marlia:
That
gets
into
what
you
want
to
cover
at
the
end
of
the
day,
which
I
have
problems
with,
but
we
actually
have
specified
record
formats
and
ways
that
they
have
to
keep
their
data
and
report
their
data
to
us.

Joe
Retzer:
Okay,
so
there
are
some
record­
keeping
requirements
as
well
as
reporting
ones?

Chris
Marlia:
Yes,
explicit
ones,
and
which
is
one
of
the
things
that
worries
me,
is
that
if
our
system
doesn't
comply
with
CROMERRR
now,
yet
it's
a
SIP­
approved
rule,
if
we
want
to
52
modify
that
and
add
it
to
those
requirements,
or
anything
like
that,
are
we
going
to
be
forced
into
remodifying
our
whole
system
in
order
to
comply
with
CROMERRR,
and
further
get
SIP
approval,
which
is
going
to
be
a
long,
drawn­
out,
delayed
process.

Robin
Roberts:
Is
there
anyone
else
here
with
Clean
Air
Act
type
state
implementation
plan
stories
to
share
or
state
programs
that
mandate
this
kind
of
electronic
record
keeping
and
reporting?

Unidentified
Male
Speaker:
TNRCC
also
mandates
electronic
reporting
and
it's
also
a
matter
of
a
long­
established
way
of
doing
business.
We're
not
going
to
be
able
to
turn
back
the
clock
on
electronic
reporting
of
emissions
inventory,
we're
not
going
to
be
able
to
turn
back
the
clock
on
electronic
reporting
of
information
because
we
don't
have
the
staff
to
do
it
and
we're
not
likely
to
get
the
legislature
to
give
us
the
fulltime
employees
to
do
that,
especially
if
we
have
to
tell
them,

"
Oh,
we
have
to
go
back
to
paper
because
the
EPA
told
us
to
because
our
current
electronic
reporting
systems
don't
meet
EPA's
requirements."
That's
not
going
to
be
a
very
popular
argument
down
at
the
state
legislature.
53
So
that
really
ties
into
the
voluntariness
of
the
rule
and
the
rule
isn't
voluntary
either
from
the
electronic
reporting
standpoint
or
from
the
record­
keeping
standpoint.

Robin
Roberts:
Well,
if
there
are
no
further
comments,

I'll
look
more
closely
this
time.
I
don't
think
so,
shall
we
move
on
to
general
criteria
then,
Evi?

Evi
Huffer:
Sure.
I'm
just
going
to
provide
you
with
a
quick
overview
of
the
general
criteria
for
electronic
recordkeeping
systems
under
Subpart
C.

There's
basically
a
total
of
nine
criteria
for
electronic
record
retention
systems.
This
criteria
was
based,
in
large
part,
as
we've
mentioned,
on
the
[
Food
and
Drug
Administration]

rule
which
was,
at
the
time,
the
only
rule
out
there
for
electronic
record
keeping.
It's
not
as
specific
as
the
[
Food
and
Drug
Administration]
rule.
Criteria
four
and
five
applies
to
electronic
signatures.

But
the
criteria
is
pretty
basic,
generate
and
maintain
accurate
and
complete
records
in
a
form
that
can't
be
altered,

maintain
e­
records
without
alteration
for
the
entire
recordretention
period,
you've
got
to
be
able
to
produce
accurate
and
complete
copies
of
e­
records
in
human
readable
as
well
as
electronic
form,
some
audit
trail
requirements,
to
use
secure,

computer­
generated
date/
time
stamped
audit
trails,
to
retain
54
those
audit
trails
for
the
entire
record
retention
period,

requirements
that
you
need
to
be
able
to
go
into
the
system,

search
and
retrieve
information
as
required
by
existing
regulations.
And
that's
the
electronic
record,
the
archives,

and,
basically,
many
of
the
issues
that
have
been
raised
to
date
concerning
these
criteria
have
been
concerned
with
the
audit
trail
requirements
as
well
as
the
archiving
requirements.

So
that
is
basically
the
requirements,
and
the
additional
two
requirements
for
electronic
records
with
an
electronic
signature
are
that
the
electronic
signature
information
needs
to
be
included
and
that
that
information
needs
to
identify
who
the
signer
is
as
well
as
the
context
of
the
signature,
is
the
person
approving,
is
he
certifying
the
electronic
record,
etc.,

and
it
needs
to
be
able
to,
it
needs
to
ensure
that
the
electronic
signature
cannot
be
modified
or
altered,
that
it
is
basically
binded
with
the
electronic
record.
They
seem
like
simple
criteria.
That
was
said
jokingly
 
for
the
record!

Mel
Swoboda:
I've
got
a
really
easy
question.
This
is
Mel
Swoboda.
Have
you
implemented
this
any
place?
In
EPA?

Well,
I'm
not
going
to
go
that
far.

Evi
Huffer:
Well
on
the
planet,
I
can't
speak
for
the
planet.
55
Joe
Retzer:
Well,
we
wouldn't
have
implemented
it,

because
it's
not
a
rule.

Mel
Swoboda:
Okay,
but
within
the
Agency,
is
there
any
place
that
would
satisfy
all
the
requirements?

Joe
Retzer:
Oh,
you
mean
for
EPA's
internal
records?

Mel
Swoboda:
EPA's
internal,
is
there
any
place
that
you
have
that
you
satisfy
all
those
requirements.
Like
your
National
Enforcement
Lab?

Evi
Huffer:
I
would
think,
going
out
on
a
limb,
that
the
answer
would
be
no
at
this
point,
but
EPA
is
in
the
process
of
revamping
its
entire
internal
electronic
record­
keeping
system.

At
any
rate,
we
bring
up
this
criteria
to
kind
of
further
the
discussion
here,
and
what
we
want
to
do
in
this
next
round
is
to
focus
on
the
problems
and
issues
that
industry
have
with
the
current
criteria.
How
will
this
general
criteria
impact
on
a
company's
current
record­
keeping
practices?

And
we've
outlined
some
questions,
some
issues
to
help
start
the
discussion,
for
instance,
which
criteria
are
the
most
difficult
to
satisfy
with
your
existing
systems?
Again,
from
what
we've
heard
so
far,
that
would
be
the
audit
trail
requirements
and
the
archiving
requirements
for
records
that
have
to
be
maintained
for
any
great
length
of
time,
as
well
as
56
the
migration
requirements
that
fall
under
the
archiving
criteria.

Do
some
of
the
criteria
pose
special
problems
for
certain
kinds
of
records?
How
does
industry
ensure
now,
if
you're
keeping
electronic
records,
how
do
you
ensure
the
integrity
and
the
reliability
of
those
records
with
the
current
systems
that
you're
using
now,
and
what
are
some
of
the
unique
issues
associated
with
electronic
signatures
from
your
perspective?

Again,
this
session
is
not
limited
to
these
areas,
they're
just
put
forth
to
help
facilitate
the
discussion.
Now
back
to
those
wonderful,
simple
criteria.

Actually,
I'd
like
you
to
think
about
this
in
just
a
slightly
different
way,
I
mean
don't
hold
back
your
critique
of
these
things,
but
if
you
think
about
the
one
through
three
and
six
through
nine,
take
out
the
E
part
and
think
about
it
as
paper,
what
you
would
do
with
your
paper
records?
Surely
you'd
want
to
generate
and
maintain
records
in
a
form
that
can't
be
altered
without
detection.
Just
think
about
your
own
business
records.
You
have
to
keep
them
without
changing
them
for
the
required
time
period.
You
want
copies
that
are
complete
and
accurate
and
you
can
get
to
them.
They're
accessible.
You
want
copies
that
are
dated
so
that
if
there
are
any
signatures
or
stuff
generated.
We
want
the
dates
on
there.
And
if
you
57
make
changes
in
those
official
records,
you
want
some
kind
of
audit
trail
of
who
changed
those
official
records
and
when.

And
you
want
to
be
able
to
find
them
when
called
upon
to
look
at
them.
And
you
want
to
keep
them
meta­
dated,
that
is,

if
somebody
is
making
a
change
on
the
record
and
you're
auditing,
you
want
to
keep
the
original
of
that
before
the
change
was
made.
I'm
talking
about
the
official
records
that
you're
generating.
So
if
you
think
about
this
as
the
kinds
of
things
you'd
like
to
have
for
a
record
system,
my
sense
is
you'd
probably
say,
well,
this
is
pretty
reasonable.

If
you
move
it
into
the
electronic
context
and
you're
suddenly
saying,
no
longer
are
we
talking
about
what
people
normally
do
on
paper.
We're
talking
about
what
they
do
electronically.
Then
you
run
into
a
lot
of
these
issues
that
we're
talking
about.
So
where
it
might
make
sense
to
say,
"
Oh
yeah,
well
just
keep
an
audit
trail.
If
you
change
the
numbers
on
your
official
record,
just
keep
a
document
of
who
did
it
and
when."
But
if
you're
talking
about,
"
Well,
gee,
now
I'm
into
an
electronic
system
and
I'm
using
Excel
or
some
spreadsheet
system.
Well
gee,
my
spreadsheet
system
doesn't
have
a
builtin
audit
function."

Are
you
saying,
"
Well,
okay,
I
want
to
keep
the
meta­
data.

Well,
no
longer
am
I
keeping
the
notations
on
the
side
of
the
58
page
or
the
version
that
has
the
stuff
crossed
out
or
stuff
somebody
initialed
in,
so
I'm
going
to
lose
that
information."

In
an
electronic
system,
if
you
go
from
electronic
to
paper,

which
seems
to
be
what
people
are
saying
is
the
only
way
to
keep
things
in
the
long
run,
you're
going
to
lose
some
information.

And
that's
really
sort
of
the
problem
we're
grappling
with
here,
even
our
original
thinking
on
this
wasn't
to
make
life
difficult
for
people.
It
was
to
say
that
there
are
certain
things
that
we
all
do,
or
should
normally
be
doing,
in
our
paper
record­
keeping
system.
And
when
you
get
into
electronic
record
keeping,
you'd
like
to
have
something
relative
analogous
to
those
kinds
of
functionality.
And
it's
when
we
started
trying
to
do
that
that
we
started
causing
all
this
heartburn.

And
it
gets
even
tougher
when
you
talk
about
signatures,

because
when
you
sign
on
paper,
you're
creating
a
forensic
there
that
somebody
can
track
to
you,
the
style
of
your
handwriting,
and
there
are
handwriting
experts
who
can
do
that.

But
if
you
electronically
sign
a
document,
how
do
we
know
it
wasn't
your
enemy
who's
trying
to
make
you
look
bad
by
changing
the
data
and
signing
your
name
on
it
as
a
way
of
covering
up
their
own
behavior.
59
So
that's
the
kind
of
problem
we're
trying
to
address
here.
And,
as
Evi
said,
well
gee,
it
looks
pretty
simple
when
you're
trying
to
do
that,
but
when
you
get
down
to
the
practicality
of
it,
that's
where
we're
hearing
you
guys
tell
us
things
like,
"
Well,
gee,
there
isn't,
electronically,
it's
tough
to
do
audit
trails."
Or,
"
Gee,
we
all
know
that
there's
no
way
that
you're
going
to
be
able
to
 
especially
some
of
EPA's
requirements
require
people
to
keep
data
for
the
life
of
the
facility
where
it's
generated.
And
those
facilities
can
last
a
long
time,
there's
no
way
that
we
really
know
to
preserve
that
meta
data
and
transfer
it
from
electronic
system
to
electronic
system."

So
part
of
this
thing
we're
trying
to
address
here
are
which
are
the
criteria
that
give
you
the
greatest
heartburn
and,
what
do
you
guys
do .

[
end
of
side
B,
end
of
transcript.]