THE NATIONAL ACADEMIES


SCIENCE, TECHNOLOGY, AND LAW PROGRAM










SEEKING ACCESS TO RESEARCH DATA

IN THE 21ST CENTURY:


AN ONGOING DIALOGUE

AMONG INTERESTED PARTIES










Monday, March 12, 2001


Then National Academies

Auditorium

2101 Constitution Avenue, NW

Washington, DC










MR. MORRISON: Thank you very much.

The final speaker is Jim Tozzi.

Agenda Item: Jim J. Tozzi, Member, Board of Advisors, Center
for Regulatory Effectiveness

MR. TOZZI: Thank you, and I would also like to second Bill's
comments about the opportunity to address this group. In fact, as you know,
there is a CAFE meeting next door, and a number of my colleagues saw me and
said, you sure spend a lot of time hanging out with scientists. I said,
yes, that is what you do when you do not get tenure.

I would also like to thank other groups that I have spoken on
this, AAAS, and a number of professional groups. Basically, I want to tell
you what our role has been in this, and just a second on the Center. The
Center was set up by the House and Senate leadership in 1996, when they
passed the Congressional Review Act. Up until last week, as you know, it
was never invoked. We had a little ergonomics rule that went down.

With that exception, the Act was set up to do that. We had
second thoughts about whether it worked. It was done and set up as a result
of Alan Morrison, and a little help from the Supreme Court striking down the
one House veto.

In any event, during those five years we at the Center really
wanted to spend time on changes in the federal regulatory process. I think
Bill Kovacs and I would call them good government statutes. I think David
Hawkins would call them no government statutes.

Basically all the good stuff David said is my resume, going back
to the quality of life review, the Paperwork Reduction Act, the
Congressional Review Act, and now data access. We got the daughter of
Shelby described to you today called data quality, which I will spend a
minute on.

Now where are we? Did we really pull up data access when this
got into the congressional debate as our highest priority of the Center?
What we were really interested in was data quality. What do we mean by data
quality? What we mean is that in recent years the federal government has
awakened to David's concerns, saying that all these things allegedly stopped
the federal regulatory process.

So, they have embarked on a process of what we call off
register regulation. They regulate outside the Federal Register. How do
they do it? They regulate by appropriation bills. They regulate by
litigation. They regulate by information. In today's world with the Net as
big as it is, the Internet is a very powerful thing to regulate. How?
Studies get on the Net by any federal agency with their logo on it, and they
are interpreted as official agency policy that once went through the same
process a rule would go. That is not necessarily true.

What we proposed was that there would be some data quality
legislation. When we had discussions with the Hill and a lot of other
people, they said, oh, before you ever work on data quality, you need to
work on data access, meaning making data available to the public. So we
worked with the committee, and I must say, Senator Shelby was the lead in
this. You can read the history of this, it is on the Center’s website:
cre.com.

There was extensive debate on this in the House before it went
to the Senate, with very little debate in the Senate. Where all the fur fle
w was in the conference committee.

Let me clear the record on my view for another reason. The idea
that EPA's study on ozone pollution was the thing that caused this, in
itself, I think is an overstatement. I think this history has been around,
all the way as Bill has said, since the report of the NRC. In addition,
there is group after group that has petitioned government. I think the Salt
Institute is another one that just called us. They have been trying to get
the data about the relation of salt to high blood pressure for years, and
cannot get it. So the idea of out EPA, I think, is probably an
overstatement.

In any event, legislation was proposed in committee report
language to have OMB do data access and data quality. As you know, it was
finally enacted. Now where does all this take us? We knew when we proposed
this that this thing was not perfect. Whether FOIA was the right way, who
knows? Whether it should have been an amendment to the Paperwork Act, who
knows?

One thing I know is that the scientific community was studying
this for 15 years and the issue is resolved. That is when the government
acts. It does not act because in my view, there is one anecdotal thing
called an EPA study. There was a long debate in the scientific community,
and it was also looked at whether this issue should be sent to the NAS, to
the AAAS, or some other group for study.

The reason it was not, is because we think it should be studied.
The only problem is that we should be acting ex post, not ex ante. That is
why this group is, I think, an important group to see how this worked. I
second Bill's side. I never heard of a debate where we are after private
data and such, or that you should not protect trade data.

Let me now tell you about the son of Shelby, or the daughter of
Shelby, as I said at first. There is an amendment -- I do not want to say
this, because I do not want to have the same criticism that it is not open.
Well, it is sort of open.

There is this very large bill that was passed, an omnibus
spending bill in the last Congress. In there, there is an amendment called
data quality. What is the data quality legislation? Why I say it is the
daughter of Shelby is, it says that OMB must issue regulations that define
minimum thresholds of data that can be disseminated by the federal
government.

It also says that OMB must issue regulations that allow any
outside party to petition a government for changing that data. I think now
that this petition is judicially reviewable; a lot of lawyers do not.

It also says that the agencies, after OMB issues those
conforming regulations, must issue their own data quality regulations. That
is aimed at all of what we think in some cases is misleading data on the
Net. Now what does this mean for you? First of all, it means that the
data that you are going to be presenting to the government as part of your
studies will probably, if it is going be used by the government, go through
that quality sieve.

Second, my personal view is not that of the Center. Dr.
Alberts, I am using the same exemption you did. I cannot speak for the
Center. The board of advisors are made up of all the successor deputies and
career heads of the office, so I do not want to be able to speak for that
group. The other aspect of it is, why should not the data quality things
apply to a whole variety of NGOs that give data to the government? To
address David Hawkins's concern, why shouldn’t the data quality provisions
apply to firms and companies that present data to the government?

So in closing, I think the data access issue is ripe. It is
going to probably go through a lot. Dr. Baldwin's group set up a very good
system. The Center fell down in one way. We were going to follow-up on
helping. I really think the answer to data access is that you have to put
that in the front of a research proposal. You have got to get a budget for
it. It has to be an integral part of your research, as opposed to something
at the tail end.