Energy United States. Congress. House. Committee on Gover.

Department of Energy's Isotope Production and Distribution Program : hearing before the Environment, Energy, and Natural Resources Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred Third Congress, first session, December 6, 1993 online

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Online LibraryEnergy United States. Congress. House. Committee on GoverDepartment of Energy's Isotope Production and Distribution Program : hearing before the Environment, Energy, and Natural Resources Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred Third Congress, first session, December 6, 1993 → online text (page 1 of 26)
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DEPARTMENT OF ENERGY'S ISOTOPE
PRODUCTION AND DISTRIBUTION PROGRAM

' Y 4. G 74/7: EN 2/30



I



Departnent of Energy's Isotope Prod...

HEAEING

BEFORE THE

ENVIRONMENT, ENERGY, AND
NATURAL RESOURCES SUBCOMMITTEE

OF THE

COMMITTEE ON

GOVERNMENT OPERATIONS

HOUSE OP REPRESENTATIVES

ONE HUNDRED THIRD CONGRESS
FIRST SESSION



DECEMBER 6, 1993



Printed for the use of the Committee on Government Operations




U.S. GOVERNMENT PRINTING OFFICE
83-493 CC WASHINGTON : 1994



For sale by the U.S. Government Printing Office
Superintendent of Documents. Congressional Sales Office, Washington, DC 20402
ISBN 0-16-046433-1



DEPAR™ENT of ENERGY'S ISOTOPE
PRODUCTION AND DISTRIBUTION PROGRAM



Y 4. e 74/7: EN 2/30

Departnent of Energy's Isotope Prod.



HEARING

BEFORE THE

ENVIRONMENT, ENERGY, AND
NATURAL RESOURCES SUBCOMMITTEE

OF THE

COMMITTEE ON

GOVERNMENT OPERATIONS

HOUSE OP REPRESENTATIVES

ONE HUNDRED THIRD CONGRESS
FIRST SESSION



DECEMBER 6, 1993



Printed for the use of the Committee on Government Operations




^



U.S. GOVERNMENT PRINTING OFFICE
83-193 CC WASHINGTON : 1994

For sale by the U.S. Government Printing Office
Superintendent of Documents. Congressional Sales Office, Washington, DC 20402
ISBN 0-16-046433-1



COMMITTEE ON GOVER^fME^^^ OPERATIONS
JOHN CONYERS, Jr., Michigan, Chairman



CARDISS COLLINS, IllinoiB
GLENN ENGLISH, Oklahoma
HENRY A. WAXMAN, California
MIKE SYNAR, Oklahoma
STEPHEN L. NEAL, North Carolina
TOM LANTOS, California
MAJOR R. OWENS, New York
EDOLPHUS TOWNS, New York
JOHN M. SPRATT, Jr., South Carolina
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
BOBBY L. RUSH, Illinois
CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
DONALD M. PAYNE, New Jersey
FLOYD H. FLAKE, New York
JAMES A. HAYES, Louisiana
CRAIG A. WASHINGTON. Texas
BARBARA-ROSE COLLINS, Michigan
CORRINE BROWN, Florida
MARJORIE MARGOLIES-MEZVINSKY,

Pennsylvania
LYNN C. WOOLSEY, California
GENE GREEN, Texas
BART STUPAK, Michigan



WILLIAM F. CLINGER, JR., Pennsylvania

AL MCCANDLESS, California

J. DENNIS HASTERT, Illinois

JON L. KYL, Arizona

CHRISTOPHER SHAYS, Connecticut

STEVEN SCHIFF, New Mexico

CHRISTOPHER COX, California

CRAIG THOMAS, Wyoming

ILEANA ROS-LEHTINEN, Florida

DICK ZIMMER, New Jersey

WILLIAM H. ZELIFF, JR., New Hampshire

JOHN M. MCHUGH, New York

STEPHEN HORN, California

DEBORAH PRYCE, Ohio

JOHN L. MICA, Florida

ROB PORTMAN, Ohio



BERNARD SANDERS, Vermont
(Independent)



Julian Epstein, StafT Director
Matthew R. Fletcher. Minority Staff Director



Environment, Energy, and Natural Resources SuBCOMMirrEE

MIKE SYNAR, Oklahoma, Chairman



KAREN L. THURMAN, Florida
CAROLYN B. MALONEY, New York
JAMES A. HAYES, Louisiana
CRAIG A. WASHINGTON, Texas
EDOLPHUS TOWNS, New York



J. DENNIS HASTERT. Illinois
JOHN M. McHUGH. New York
DEBORAH PRYCE. Ohio
JOHN L. MICA. Florida



BERNARD SANDERS. Vermont (Ind.)



Ex Officio

JOHN CONYERS. JR., Michigan WILLIAM F. CLINGER. JR., Pennsylvania

Sandra Z. Harris. Stafjf Director

David M. Berick, Professional Staff Member

Elisabeth R. Campbell. Clerk

CHARU E. Coon. Minority Professional Staff



(II)



CONTENTS



Page

Hearing held on December 6, 1993 1

Statement of:

Atcher, Robert W., Ph.D., investigator, University of Chicago Medical
Center, Chicago, IL, on behalf of the Society of Nuclear Medicine and
the American College of Nuclear Physicians 13

Brown, Roy W., director, regulatory and professional affairs, Mallinckrodt
Medical, Inc., St. Louis, MO, on behalf of the Council on Radionuclides
and Radiopharmaceuticals [CORAR], Inc 30

Friedman, Greg, deputy assistant inspector general for audit operations,
U.S. Department of Energy 63

Goldstein, Ira, partner, Arthur Andersen & Co., Washington, DC 79

Hahn, Richard L., Ph.D., nuclear scientist and group leader, chemistry
department, Brookhaven National Laboratory, on behalf of the Na-
tional Academy of Sciences 3

Synar, Hon. Mike, a Representative in Congress from the State of Okla-
homa, and chairman. Environment, Energy, and Natural Resources
Subcommittee: Opening statement 1

Trevena, Dr. Iain, vice president, isotope products, Nordion International,

Inc., Kanata, Ontario, Canada 40

White, William, Deputy Secretary, U.S. Department of Energy, Washing-
ton, DC, accompanied by E.C. Brolin, Acting Deputy Director, Office
of Nuclear Energy; Owen W. Lowe, Director, Office of Isotope Produc-
tion and Distribution; Dr. Ari Patrinos, Acting Associate Director, Of-
fice of Health and Environmental Research; and Dr. Donald F. Knuth,
Deputy Assistant Secretary for Facilities, Office of Defense Programs ... 107
Letters, statements, etc., submitted for the record by:

Atcher, Robert W., Ph.D., investigator. University of Chicago Medical
Center, Chicago, IL, on behalf oi the Society of Nuclear Medicine and
the American College of Nuclear Physicians: Prepared statement 16

Brolin, E.C, Acting Deputy Director, Office of Nuclear Energy, U.S. De-
partment of Ener^: Information concerning the design goal of the
Advanced Neutron Source 140

Brown, Roy W., director, regulatory and professional affairs, Mallinckrodt
Medical, Inc., St. Louis, MO, on behali of the Council on Radionuclides
and Radiopharmaceuticals [CORAR], Inc.: Prepared statement 32

Goldstein, Ira, partner, Arthur Andersen & Co., Washington, DC: Pre-
pared statement 82

Hahn, Richard L., Ph.D., nuclear scientist and group leader, chemistry
department, Brookhaven National Laboratory, on behalf of the Na-
tional Academy of Sciences: Prepared statement 7

Knuth, Dr. Donald F., Deputy Assistant Secretary for Facilities, Office
of Defense Programs, U.S. Department of Energy: Information concern-
ing fuel assemblies 126

Layton, John C, inspector general, U.S. Department of Energy: Prepared
statement 66

Patrinos, Dr. Ari, Acting Associate Director, Office of Health and Envi-
ronmental Research, U.S. Department of Energy:

Information concerning a cost comparison study 145

Information concerning an internal, informal review of the Purdue
report 146

Trevena, Dr. Iain, vice president, isotope products, Nordion International,
Inc., Kanata, Ontario, Canada: Prepared statement 42

White, William, Deputy Secretary, U.S. Department of Energy, Washing-
ton, DC: Prepared statement 110

(HI)



rv

Page

APPENDIX
Material submitted for the hearing record 163



DEPARTMENT OF ENERGY'S ISOTOPE
PRODUCTION AND DISTRIBUTION PROGRAM



MONDAY, DECEMBER 6, 1993

House of Representatives,

Environment, Energy,
AND Natural Resources Subcommittee
OF THE Committee on Government Operations,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:03 a.m., in room
2247, Raybum House Office Building, Hon. Mike Synar (chairman
of the subcommittee) presiding.

Present: Representative Mike Synar.

Also present: Representatives Glenn English and William F.
dinger, Jr.

Staff present: Sandra Z. Harris, staff director; David M. Berick,
professional staff member; Elisabeth R. Campbell, clerk; and Charli
E. Coon, minority professional staff, Committee on Government
Operations.

OPENING STATEMENT OF CHAIRMAN SYNAR

Mr. Synar. The subcommittee will come to order. The sub-
committee meets today to continue hearings we began in August
1992 on the Department of Energy's Isotope Production and Dis-
tribution Program and the reliability of America's supply of iso-
topes for medical, research, and industrial purposes.

Given the arcane nature of this subject, the first question many
Members and many in the listening audience might ask is, what
is an isotope and why should we care about this? The reason is
very simple. Isotopes are critical to millions of individuals and their
families and to the Nation's health care system as a whole. Thou-
sands of our citizens rely upon isotopes for diagnostic medical pro-
cedures each and every day, and annually up to 50,000 citizens rely
upon them for therapy to treat illnesses such as thyroid disease.

These isotopes also support research and industrial activities
that are essential to the Nation's competitiveness and economic
health. Indeed, by DOE's own admission, isotopes provided by the
Department "have touched the lives of virtually every citizen" in
our country.

Yet despite the essential nature of isotopes to our health of our
citizens and the economic well-being of our Nation, the Department
of Energy told us in August 1992 that the program simply "wasn't
a high priority." This position was so alarming and discouraging
that Congressman dinger and I immediately wrote then-Depart-
ment of Energy Secretary Watkins about the critical need to reex-

(1)



amine this essential program and to resolve the problems that we
are going to explore again today.

Unfortunately, our extensive review since then suggests that
those problems have not been resolved and that our supply situa-
tion today is even more precarious than it was 15 months ago. For
example, approximately 90 percent of all United States medical iso-
tope requirements are now dependent upon a single isotope produc-
tion reactor in Canada. In the event of a reactor outage or work
stoppage at that Canadian facility, the United States has no
backup capability. As a result of any shutdown there, we would
face a virtual crisis in the health community within a matter of
days.

Earlier this year, the medical community expressed concern that
Congress should not ignore "the warning signs for complete break-
down of the radioisotope infrastructure" in the United States. I
hope this followup hearing makes clear that we are not ignoring
the problems facing this program and that we are not satisfied to
allow the Department to ignore them either. In fact, this is pre-
cisely why we are here todfay, even though Congress is in recess.

Given the importance of isotopes for medical, research, and in-
dustrial activities, we are extremely concerned over the Depart-
ment's lack of progress in coming to grips with the problems we ex-
amined in our last hearing. Facing up to these problems may have
budgetary impacts on the Department. Because the administration
is in the process of completing work on the fiscal year 1995 budget
for those programs, I thought it would be unwise, very candidly, to
wait until Congress returns in late January to schedule this hear-
ing.

We are going to examine this matter in detail today. We are
going to look at the Department, what the Department has done
since that August 1992 hearing to resolve the problems facing the
program, and we are going to look at what they have not done. We
are going to ask them for certain assurances today from the high-
est levels of the Department, and for progress reports in the future
so that we can know that commitments are being fulfilled by mean-
ingful action.

I want to thank my colleague, Mr. English, who is not a member
of the subcommittee, but a member of the full Committee on Gov-
ernment Operations, for joining us this morning; and I would call
on him at this time for any opening statement.

Mr. English. Well, I simply want to thank the chairman for his
hospitality in asking me to join him; and it is a pleasure to be here
once again, but I have no opening statement.

Mr. Synar. Thank you, Glenn.

Mr. Hastert will have an opening statement, and we will leave
the record open for all opening statements from our colleagues.

At this time, I would like to call on our first panel this morning,
Dr. Richard Hahn, Brookhaven National Laboratory; Roy W.
Brown, Mallinckrodt Medical Inc.; Dr. Robert Atcher, University of
Chicago Medical Center; and Dr. Iain Trevena, Nordion Inter-
national. If they would all please come forward.

Gentlemen, in order not to prejudice past or future witnesses, it
is the policy of this subcommittee to swear in all our witnesses. Do
any of you have any objection to being sworn?



If not, if you would rise and raise your right hands.

[Witnesses sworn.]

Mr. Synar. Welcome, gentlemen, and we do appreciate your com-
ing today, even though we are in recess. We will have Members
coming in and out.

This subject is so important, as I said in my opening statement,
that I thought it just couldn't wait until next year.

Dr. Hahn, why don't we begin with you? First of all, welcome
back. You were with us in August 1992, and I would be very inter-
ested to hear your thoughts as we have proceeded over these last
months.

Each one of your statements will be made part of the record, and
we ask you all to summarize now in about 5 minutes apiece.

Dr. Hahn.

STATEMENT OF RICHARD L. HAHN, Ph.D., NUCLEAR SCI-
ENTIST AND GROUP LEADER, CHEMISTRY DEPARTMENT,
BROOKHAVEN NATIONAL LABORATORY, ON BEHALF OF THE
NATIONAL ACADEMY OF SCIENCES

Dr. Hahn. Thank you, Mr. Chairman. I am very pleased to be
back. As you may recall, when I was here in August 1992, I ap-
peared as chairman of the committee of the National Academy of
Sciences/National Research Council [NRC] that had been looking at
this issue. It turned out that this past summer my 6 years on that
NRC committee ended, but you were kind enough to ask me to
come back to testify.

Just a few words of introduction: my whole career has essentially
been spent at DOE national laboratories. I have been at
Brookhaven the last 7 years. Before that, I spent about 24 years
at Oak Ridge. I have been involved in the research area of nuclear
chemistry and nuclear physics. I have used many isotopes; essen-
tially my whole career has been built on using enriched and radio-
active isotopes.

I am not involved in any way in isotope production, but I am fa-
miliar with many of the facilities at the different DOE labs and the
people who work there.

Now for a little history: When I spoke to you in the summer of
1992, the NRC committee I chaired had, a few months before, held
an informal workshop to look at the various problems that people
in different scientific communities were finding with regard to iso-
tope supply. Shortly before you held your hearing, the GAG issued
its report; and then at the hearing itself, the DGE announced that
the Arthur Andersen consulting company was going to evaluate
their program. Andersen Co. issued its report recently. I will allude
to that report briefly in a couple of my verbal comments.

To make the record clear, I am here essentially expressing my
personal views in the sense that there have been no recent formal
documents about isotopes written by the National Academy. Even
our committee's 1992 workshop was an informal thing, organized
to scope things out. So there is nothing formal that I can quote. Gn
the other hand, the Academy's Institute of Medicine currently is
doing a study that was, I believe, requested by the DGE to look
mainly at the issue of the biomedical isotopes; a statement of the
scope of that study is available.



Now, what about the current status of DOE's isotope production?
So far as I could see in looking back at my written testimony from
August 1992, things have not changed very much in the last IV2
years. Even with regard to the recommendations of the GAO report
on how to improve the situation at the different isotope production
centers in this country, it looks as if in most instances, conditions
have continued to deteriorate just because nothing positive has
been done.

The electromagnetic isotope separators, the calutrons, which are
located at Oak Ridge, have long been the work horses of isotope en-
richment because they can handle many of the different elements
in the periodic table. Electromagnetic separation, in a sense, is a
generic process.

The calutrons' program there is currently barely viable. Their ex-
isting inventory of isotopes, not only in what was called the tradi-
tional sales pool, but also in a select collection of isotopes reserved
for research, is now being drawn down in order to meet current
sales orders. The managers there have told me that they have been
able to reduce their costs by cutting back to what they call a skele-
ton crew. But by the same token, many people who were trained
in operating those facilities have been lost.

A very serious complication in the isotopes picture is the strong
sales competition from the Russian isotope inventory. The report by
the Andersen company states that the current worldwide market
for stable isotopes is on the order of $8 to $10 million, and the Rus-
sians got into that market before the fall of the Soviet Union, even
before they adopted some of the tenets of capitalism. They got into
it aggressively, routinely undercutting published DOE prices by at
least 10 percent.

At present, they are working very hard to sell as many isotopes
as they can, and it looks as ii they are willing to cut their prices
to the bone, just to have the market.

In fact, just last Friday there was an article in the New York
Times; I have brought a few copies with me, in case you are inter-
ested. The Times has been running a series on what is happening
in Russia in terms of shifting over from a military dominated to a
consumer-dominated economy. In this last article in the series, a
laboratory outside of Moscow was mentioned that was run by the
Russian Atomic Energy Ministry. The article describes Russian ef-
forts there at what they call "conversion"; and it was mentioned
specifically that they are exploiting a large Western market that
uses radioactive isotopes for cancer diagnosis and treatment. So the
Russians may be long-term players in this isotopes market.

More and more of my colleagues in the basic research community
tell me that they are buying their isotopes, their enriched
nonradioactive isotopes, from the Russians — mainly because of the
lower prices. The quality of the product in general seems to be

good. The reliability of the delivery also seems to be satisfactory.
In the other hand, I have heard some stories of dissatisfied cus-
tomers having problems, for example, that the isotope enrichment
was not as advertised when they received the product.

I myself had an experience concerning United States and Rus-
sian isotope production in my work in an international scientific
collaboration. We wanted to buy about 100 pounds of an enriched



chromium isotope from the DOE gas centrifuge facihty at Oak
Ridge, and in deaHng with the facility managers, even though they
were trying to operate as a business, I found that they had essen-
tially no freedom to negotiate. They had rather strict financial
rules that they were bound by.

In fact, there was a for-profit company in Western Europe that
was underbidding Oak Ridge, claiming that it could make a profit
even at the lower price. In the end, my European colleagues, who
raised the money for this particular aspect of the work, decided to
go to the Russian gas centrifuges, and they got a price about half
of what Oak Ridge was offering.

So during the time that the Russians were manufacturing the
material for us, the gas centrifuges at Oak Ridge essentially were
put into a standby mode.

At present, it looks as if the United States research community
is getting the isotopes it needs, either from the existing United
States inventories or from the Russian production, but there is
much uncertainty concerning the Russian program. No one I have
spoken to in the isotopes field in the United States can tell me the
extent of the Russian inventories or what priorities they have in
terms of future production. We don't know if they are just drawing
down their inventory or if they are actually replenishing their sup-
plies with new isotope production, so their reliability as a supplier
for the long term is not clear.

I want to point out another aspect of uncertainty, namely that
unless the situation changes in this country, if the Russians keep
on underbidding the other isotope producers, it may well turn out
that they become the prime producer, the prime supplier, in the
worldwide market. I think there is a serious question to ponder,
that is, has anyone really considered the long-term ramifications
for science and technology in this country if we get to a stage
where we have to go overseas to one supplier for all of the enriched
materials we need?

At this point, I would like to say a few words about the impor-
tance of isotopes in research. There are about 230 isotopes that are
listed in the DOE-IPDP inventory, but only a handful of these are
what you might call big sellers in the commercial market, in the
biomedical market; the rest are used primarily in research. These
"research isotopes" are bought intermittently in relatively small
amounts, tenths of a gram to a few grams at a time. So the percep-
tion exists that these isotopes are relatively unimportant finan-
cially.

Many members of the research community nationally are con-
cerned that as more emphasis is put on the use of the small group
of profitable isotopes in medicine and in industry — and certainly we
realize the importance of those uses — all the other isotopes may fall
by the wayside, I was thinking about the importance of isotopes in
research and about how I could get across the idea of how a sci-
entist would use these things, and I came up with an analogy, I
am not sure how apt it is, but I will play it by you.

In a lot of ways, isotopes are the tools of the scientific trade,
what you might call part of the "nuts and bolts" of doing the work;
and I thought, what if there were a consumer who went to his fa-
vorite hardware store, expecting to find some of the nuts and bolts



he needed for a job. How would he react if he were told that the
price of an item suddenly had gone up by a factor of 5 or 10, or
that the item was back-ordered with an indefinite deliver>' date, or
perhaps worst of all, that it would no longer be manufactured?

In a similar way, a scientist really doesn't think too much about
the supply of a particular isotope. He expects that he can pick up
the phone, call the isotope sales office, and say "I need this much,
how much is it and when can you ship it?" Now, if he needs an ex-
traordinarily large amount, then he is prepared perhaps to nego-
tiate or to wait. But for many isotopes he expects his purchase to
be routine.

If instead he finds that the particular isotope he needs is not
available, it is conceivable he can find a substitute and still carry
out his research. But if he gets to the point where many isotopes
have disappeared or if the prices have become unaffbrdable, then
it is very likely that his particular research will have to be termi-
nated. I know of a few real-life situations that have followed this
scenario.

On top of this, in terms of trying to predict future isotope use,
we must realize that research is very dependent on recent results.
For example, I could perhaps predict what isotopes I might need
5 years from now, but it is very possible that 5 years from now I
might have found that there was something more important to pur-
sue than my original prediction,

Mr. Synar, Doctor, why don't you start to conclude?

Dr. Hahn. Yes, OK; two last points I want to make.

The first is that the radioactive isotopes that will be used in
medicine also are used in research. In a lot of ways, the medical
isotopes are the spinoff" from research that was done earlier by
physicists and chemists; and then people who were interested in
the biological and medical applications realized their potential im-
portance. So even in the field of nuclear medicine, it is not as if
you pick an isotope today and tomorrow you can administer it to
a patient. It takes years of research and development; in addition,
one is always on the lookout for new products, so you need isotopes.

The very last comments I want to make have to do with what
the Arthur Andersen report had to say in terms of production of
these so-called financially unimportant research isotopes. They con-
cluded that trying to produce these many different isotopes is not
commercially viable; it is a venture that is bound to lose money.
The Andersen report made the statement, that if you are going to
try to justify production of research isotopes solely in business
terms, you should essentially consider shutting the production
down. However, if there are other reasons that are considered im-
portant to justify future production, then you should evaluate those
reasons independent of business considerations. I would argue, be-
cause so much of the research in this country, which is funded by
so many diff*erent Federal agencies, relies on these isotopes, that
one could make an argument that it is in the national interest to



Online LibraryEnergy United States. Congress. House. Committee on GoverDepartment of Energy's Isotope Production and Distribution Program : hearing before the Environment, Energy, and Natural Resources Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred Third Congress, first session, December 6, 1993 → online text (page 1 of 26)