[Senate Hearing 105-686]
[From the U.S. Government Printing Office]


                                                        S. Hrg. 105-686

 
      NATIONAL CANCER INSTITUTE'S MANAGEMENT OF RADIATION STUDIES

=======================================================================


                                HEARING

                               before the

                               PERMANENT
                     SUBCOMMITTEE ON INVESTIGATIONS

                                 of the

                              COMMITTEE ON
                          GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE

                       ONE HUNDRED FIFTH CONGRESS

                             SECOND SESSION
                               __________

                           SEPTEMBER 16, 1998

                               __________

      Printed for the use of the Committee on Governmental Affairs

                               -----------

                    U.S. GOVERNMENT PRINTING OFFICE
51-644 CC                   WASHINGTON : 1998

_______________________________________________________________________
For sale by the Superintendent of Documents, Congressional Sales Office
         U.S. Government Printing Office, Washington, DC 20402



                   COMMITTEE ON GOVERNMENTAL AFFAIRS

                   FRED THOMPSON, Tennessee, Chairman
WILLIAM V. ROTH, Jr., Delaware       JOHN GLENN, Ohio
TED STEVENS, Alaska                  CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine              JOSEPH I. LIEBERMAN, Connecticut
SAM BROWNBACK, Kansas                DANIEL K. AKAKA, Hawaii
PETE V. DOMENICI, New Mexico         RICHARD J. DURBIN, Illinois
THAD COCHRAN, Mississippi            ROBERT G. TORRICELLI,
DON NICKLES, Oklahoma                  New Jersey
ARLEN SPECTER, Pennsylvania          MAX CLELAND, Georgia
             Hannah S. Sistare, Staff Director and Counsel
                 Leonard Weiss, Minority Staff Director
                       Lynn L. Baker, Chief Clerk

                                 ------                                

                PERMANENT SUBCOMMITTEE ON INVESTIGATIONS

                   SUSAN M. COLLINS, Maine, Chairman
WILLIAM V. ROTH, Jr., Delaware       JOHN GLENN, Ohio
TED STEVENS, Alaska                  CARL LEVIN, Michigan
SAM BROWNBACK, Kansas                JOSEPH I. LIEBERMAN, Connecticut
PETE V. DOMENICI, New Mexico         DANIEL K. AKAKA, Hawaii
THAD COCHRAN, Mississippi            RICHARD J. DURBIN, Illinois
DON NICKLES, Oklahoma                ROBERT G. TORRICELLI, New Jersey
ARLEN SPECTER, Pennsylvania          MAX CLELAND, Georgia
           Timothy J. Shea, Chief Counsel and Staff Director
                 David McKean, Minority Staff Director
                 Pamela Marple, Minority Chief Counsel
                     Mary D. Robertson, Chief Clerk



                            C O N T E N T S

                                 ------                                
Opening statements:
                                                                   Page
    Senator Collins..............................................     1
    Senator Glenn................................................     3
    Senator Durbin...............................................    23

                               WITNESSES
                     Wednesday, September 16, 1998

Hon. Tom Harkin, a U.S. Senator from the State of Iowa...........     6
F. Owen Hoffman, Ph.D., President, SENES Oak Ridge, Inc., Center 
  for Risk Analysis, Consultant to the National Cancer 
  Institute's Study, Oak Ridge, Tennessee........................    12
Barry L. Johnson, Ph.D., Assistant Surgeon General, Assistant 
  Administrator, Agency for Toxic Substances and Disease 
  Registry, Department of Health and Human Services; accompanied 
  by Jeffrey Lybarger, M.D., Director, Division of Health Studies    15
Bruce Wachholz, Ph.D., Chief, Radiation Effects Branch, National 
  Cancer Institute...............................................    28
Richard D. Klausner, M.D., Director, National Cancer Institute, 
  National Institutes of Health, Department of Health and Human 
  Services.......................................................    30
William F. Raub, Ph.D., Deputy Assistant Secretary for Science 
  Policy, Department of Health and Human Services................    31

                     Alphabetical List of Witnesses

Harkin, Hon. Tom:
    Testimony....................................................     6
    Prepared Statement...........................................    45
Hoffman, F. Owen, Ph.D.:
    Testimony....................................................    12
    Prepared Statement...........................................    48
Johnson, Barry L., Ph.D.:
    Testimony....................................................    15
    Prepared Statement...........................................    61
Klausner, Richard D., M.D.:
    Testimony....................................................    30
    Prepared Statement...........................................    75
Raub, William F., Ph.D.:
    Testimony....................................................    31
    Prepared Statement...........................................    87
Wachholz, Bruce, Ph.D.:
    Testimony....................................................    28

                                APPENDIX

              Exhibit List for September 16, 1998 Hearing

* May be found in the files of the Subcommittee

Page.............................................................
 1a. GEstimated Exposures and Thyroid Doses Received by the 
  American People from Iodine-131 in Fallout Following Nevada 
  Atmospheric Nuclear Bomb Tests, A Report from the National 
  Cancer Institute, October 1997, U.S. Department of Health and 
  Human Services, National Institutes of Health..................     *

   b. GNational Cancer Institute maps of exposure, State of 
  Maine:
      GChart 1: ``Estimates of I-131 thyroid doses (rad) for 
  persons born on January 1, 1952: (Average diet; average milk 
  consumption)''.................................................    90
      GChart 2: ``Estimates of I-131 thyroid doses (rad) for 
  persons born on January 1, 1952: (Average diet; high milk 
  consumption)''.................................................    91
      GChart 3: ``Estimates of I-131 thyroid doses (rad) for 
  persons born on January 1, 1952: (Average diet; milk from 
  `backyard cow')''..............................................    92

   c. GNational Cancer Institute maps of exposure, States of 
  Arkansas, Connecticut, Delaware, Georgia, Illinois, Kansas, 
  Michigan, Mississippi, New Jersey, New Mexico, Ohio, Oklahoma, 
  and Pennsylvania with ``Estimates of I-131 thyroid doses (rad) 
  for personal born on January 1, 1952 (Average diet; average 
  milk consumption/high milk consumption/milk from `backyard 
  cow')''........................................................     *

 2. GTimeline of Events, National Cancer Institute's I-131 Report    93

 3. GMemoranda prepared by Robert Roach, Senior Counsel to the 
  Minority; Beth Stein, Counsel to the Minority; and William 
  McDaniel, Investigator to the Minority, Permanent Subcommittee 
  on Investigations, dated October 1998, regarding ``PSI Hearing 
  on the National Cancer Institute's Management of Radiation 
  Health Effects Research''......................................    95

 4. GSubmission for the Record of Drs. David Rush and H. Jack 
  Geiger, Physicians for Social Responsibility...................   746

 5. GSubmission for the Record of Paul Gilman, Ph.D., National 
  Research Council, Commission of Life Sciences..................   765

 6. GMaterial regarding the 3-5 year budgets for the Chernobyl 
  studies, submitted by Dr. Richard Klausner, Director, National 
  Cancer Institute...............................................   767

 7. GSubmission for the Record of The Hon. Ted Stevens, a U.S. 
  Senator from the State of Alaska, regarding radiation exposure 
  on Amchitka workers............................................   771

 8. GSubmission for the Record of the Alliance for Nuclear 
  Accountability.................................................   817

 9. GSubmission for the Record of Chuck Broscious, Executive 
  Director, Environmental Defense Institute......................   827

10. GSubmission for the Record of Tim Connor, Chairman, 
  Subcommittee for Community Affairs, Advisory Committee For 
  Energy-Related Epidemiologic Research..........................   830

11. GSubmission for the Record of Trisha T. Pritikin, a citizen 
  member of the community subcommittee to the Advisory Committee 
  on Energy Related Epidemiologic Research.......................   843

12. GSubmission for the Record of Kathleen M. Tucker, President, 
  Health and Energy Institute....................................   854

13. GPublic Law 97-414, Sec. 7(a) (January 4, 1983)..............   893


      NATIONAL CANCER INSTITUTE'S MANAGEMENT OF RADIATION STUDIES

                              ----------                              


                     WEDNESDAY, SEPTEMBER 16, 1998

                                       U.S. Senate,
                Permanent Subcommittee on Investigations,  
                  of the Committee on Governmental Affairs,
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 9:38 a.m., in 
room SD-342, Dirksen Senate Office Building, Hon. Susan M. 
Collins, Chairman of the Subcommittee, presiding.
    Present: Senators Collins, Glenn, and Durbin.
    Staff Present: Timothy J. Shea, Chief Counsel/Staff 
Director; Mary D. Robertson, Chief Clerk; Pamela Marple, 
Minority Chief Counsel; David McKean, Minority Staff Director; 
Bob Roach, Counsel to the Minority; Beth Stein, Counsel to the 
Minority; Bill McDaniel, Investigator to Minority; John 
Neumann, Investigator (Detailee, GAO); Kirk E. Walder, 
Investigator; Lindsey E. Ledwin, Staff Assistant; Felicia 
Knight (Sen. Collins); Chris Dockerty, (Sen. Thompson); Kevin 
Mathias (Sen. Specter); Len Weiss (Governmental Affairs/Sen. 
Glenn); Marianne Upton, (Sen. Durbin); Lynn Kimmerly and Donna 
Berry (Sen. Cleland); Gabriel Goldstein (Sen. Lieberman); and 
Antigone Popamianos (Sen. Levin).

              OPENING STATEMENT OF SENATOR COLLINS

    Senator Collins. The Subcommittee will please come to 
order.
    Today, the Permanent Subcommittee on Investigations will 
examine the National Cancer Institute's management of an 
important scientific study which assessed the radiation effects 
of nuclear weapons tests. This hearing is the result of an 
investigation initiated and led by the Ranking Minority Member, 
the distinguished Senator from Ohio. Senator John Glenn and his 
staff should be commended for their work on this investigation, 
which expanded on an earlier effort by two of our colleagues. 
This matter was first raised by Senators Arlen Specter and Tom 
Harkin at a Senate Appropriations Subcommittee hearing held in 
October 1997, and I want to commend them for their leadership 
as well.
    Our focus this morning is on one particularly significant 
government study that assessed the exposure of the American 
people to radiation from government nuclear weapons testing in 
the 1950's, a study that took 14 years to complete. We will 
explore whether or not management problems delayed this report, 
and if so, how to ensure that such problems do not affect 
future studies managed by the National Cancer Institute or the 
Department of Health and Human Services.
    By way of background, in 1983, the Congress directed the 
Department of Health and Human Services to assess the potential 
exposure of the American people to Iodine-131, one of the 
radioactive elements in the fallout from aboveground nuclear 
tests. Assessing the health risks facing the public as a result 
of this exposure was also part of this directive. The 
Department delegated the task of conducting this review to the 
National Cancer Institute, which finally released its lengthy 
study in October 1997.
    The findings in the NCI study were sobering, to say the 
least. Besides the known areas of contamination around the 
Nevada test site, the data showed that many other parts of the 
country were also contaminated because weather patterns at the 
time disbursed radioactive material across America. For some of 
the nuclear tests, the report found, people as far away as 
Aroostook County, Maine, where I was born and grew up, may have 
received as much exposure to radiation as people living in 
Nevada and Utah.
    It came as a real shock to me when I read this part of the 
report and looked at the maps that outline the States that had 
received the highest radiation exposure.
    In addition, individuals who were young children at the 
time of the testing and who drank large quantities of locally 
produced milk received significantly higher concentrations of 
radiation than did adults in the same area.
    This investigation raises important policy questions about 
openness and trust in government. Did the Federal Government 
fulfill its duty to report its findings to the American people? 
Specifically, why was the report published 14 years after it 
was commissioned and without the important public health 
information about the risk of cancer associated with the 
aboveground nuclear tests? Did the Department of Health and 
Human Services fulfill its duty to see that this study was done 
in a complete and timely manner, as directed by Congress? And, 
finally, what are the public health implications of this study 
as assessed by the report published by the National Academy of 
Sciences?
    The survival of public institutions in a democracy depends 
on the public's trust and faith in them--in their competence, 
their integrity, and their fundamental honesty. Studies with 
potentially significant health implications must be 
communicated to the American people as soon as possible to 
ensure public confidence in the Federal agencies responsible 
for such areas.
    To explore the issues surrounding this radiation study, we 
will hear from several witnesses this morning. Our first 
witness is the distinguished Senator from Iowa, Senator Tom 
Harkin. He has a deeply personal interest in this matter and 
also serves as the Ranking Minority Member of the Labor, Health 
and Human Services, and Education, Subcommittee of the 
Appropriations Subcommittee.
    Our next panel of witnesses consists of Dr. Owen Hoffman 
and Dr. Barry Johnson, who will testify about the significance 
of the NCI's findings on the radiation resulting from nuclear 
weapons testing.
    We will then hear from Dr. Bruce Wachholz, the NCI official 
who managed the radiation study, who will address why the NCI 
took 14 years to issue the report.
    Our final witness this morning is Dr. William Raub, Deputy 
Assistant Secretary for Science Policy and Science Advisor to 
the Secretary of the Department of Health and Human Services.
    We look forward to hearing all of this testimony.
    Before recognizing the distinguished Senator from Ohio, I 
would like to set the record straight about certain 
representations that have been made to the press about this 
investigation and hearing. I was concerned to read in one 
report that ``a Senate panel'' suggested that the project 
director in this case had a conflict of interest and that ``a 
U.S. Senate investigation'' reached a final conclusion about 
this matter before this hearing. Let me make clear that no such 
finding has been made and no such conclusions have been 
reached. Indeed, that is why we are here today. That is the 
purpose of this hearing, and we are here to listen to the 
evidence and explore the facts with an open mind. Certainly, 
there have been no findings or conclusions reached by this 
Subcommittee, and I just want the record to be clear on those 
matters.
    As I mentioned earlier, this investigation was directed, 
initiated, and led by the minority staff, and Senator Glenn may 
have more to say about this issue. At this time, I would like 
to recognize my colleague, the distinguished Senator from Ohio, 
Senator Glenn, for any comments that he might have.

               OPENING STATEMENT OF SENATOR GLENN

    Senator Glenn. Thank you very much, Madam Chairman.
    The problems here started back 40-some years ago, back in 
the days of the Cold War, and over the past several years, the 
American people have learned about the sad legacy of the U.S. 
nuclear weapons testing program. Going clear back into the 
1950's and spurred by an overwhelming sense of national 
security, which many of us here today are old enough to 
remember where the Cold War was preeminent and where we did a 
lot of things that, in retrospect or in 20/20 hindsight, we 
probably would do a lot differently today. But those were the 
days when the priorities were in a little different direction 
than they are today.
    With the sense of national security, the Federal Government 
failed to inform the public of the nuclear testing program's 
potential dangers as a result of nuclear fallout. And making 
matters worse, for many years our government continued to hide 
those facts from the public despite mounting evidence that 
people, particularly young people, may have been harmed.
    The history is by now well documented, and to its credit, 
the Congress has played an important role in reconstructing 
that history. We worked hard to open up the files. We worked 
hard to make sure that current as well as future studies on 
radiation health effects are as transparent as they should have 
been for the nuclear testing program during the 1950's. We have 
worked to make both the nature of the research and the results 
of any study accessible to the public so Americans know what 
the dangers are, and, if they can take precautions of some kind 
with their children or themselves, even at this late date, that 
those be available to them.
    Overall, we have made progress with these reform efforts, 
but the struggle is ongoing. I have recently introduced 
legislation that would ensure that no one will ever be subject 
to governmental experimentation of any kind without their 
knowledge and informed consent. This is just common sense. In 
addition, this Committee has passed some legislation in the 
past regarding some of the things that happened with radiation 
studies in Cincinnati. Some of you that have followed the work 
of this Committee will be familiar with that legislation.
    Today, we are going to examine the management and openness 
of one particular research effort, one with a long history. It 
started back some 15 years ago when Congress passed an 
amendment to the Orphan Drug Act directing the Secretary of the 
Department of Health and Human Services to provide the public 
with complete information on both the amount and effects of the 
radioactive iodine released into the atmosphere during the 
aboveground nuclear weapons testing program conducted by the 
Federal Government in Nevada in the 1950's and early 1960's. 
This task was delegated to the National Cancer Institute and 
only last year, in 1997, some 14 years after receiving a 
mandate from Congress, did the NCI complete its report.
    Although this hearing will not attempt to evaluate all the 
science underlying the report, it is worth briefly 
recapitulating NCI's most significant findings. They are that 
the weapons test distributed high levels of nuclear fallout 
across the country--I mean clear across the country, too, as 
the Chairman just stated, some in a particular area because of 
the vagaries of weather patterns and so on in Maine, about as 
far as you could get and still be in the continental United 
States. So it came down in that area where she grew up, 
literally. We are not implying that you have any effects from 
this, of course, and we hope you do not, but that just shows 
how far these things go sometimes, quite apart from where the 
test actually occurred.
    In a number of other areas, including the Northern Plains, 
the Midwest, and Northeast, individuals received doses of I-131 
to their thyroid that were comparable to and in some cases 
exceeded the doses received by citizens living near the test 
site in Nevada.
    Second, Americans across the Nation received doses of 
radiation at levels that were much higher than previously 
believed. It is estimated that 3.5 million children received an 
average cumulative dose of 10.3 rads of Iodine-131. Some 
children in certain areas may have received cumulative doses as 
high as 100 rads.
    Also, NCI has since estimated that 11,000 to 212,000 
people, which is quite a wide spread, we would acknowledge, 
which may show some of the difficulties in assessing some of 
the dangers from this, that those numbers of people may develop 
radiation-induced thyroid cancer from the weapons test fallout. 
Fortunately, this type of cancer is rarely life-threatening, 
but it is in some cases, of course.
    When I saw the important information revealed in this 
report, I was particularly concerned that it took 14 years to 
complete the study. I asked the staff of the Subcommittee to 
look into the matter and was quite surprised and disappointed 
by what we have found.
    Before getting into what our investigation uncovered, I 
would first like to address the same item that the Chairman 
addressed a moment ago regarding a news story that appeared 
yesterday and another one this morning, but particularly the 
one yesterday that appeared alleging that this Subcommittee 
challenged the ethics of Dr. Wachholz during the NCI's I-131 
study. The reporter quoted from a preliminary draft of an 
internal memorandum which I had never seen or approved. I 
should add, however, that this article did not mention the 
finding of that memorandum ``that the Subcommittee found no 
evidence to suggest any potential conflicts affected the I-131 
report in any way.''
    I want to state for the record, and very emphatically, that 
I do not challenge the ethics of Dr. Wachholz and that today's 
hearing is focused instead on the management and issuance of 
the I-131 report itself.
    Let's turn to some of the problems with the I-131 report. 
It was delayed at least 4 years, perhaps longer. The NCI study 
was plagued by trouble with management, lack of internal 
oversight, and lack of public participation and openness. In 
addition, the NCI's participation in ongoing and critical 
studies of the Chernobyl accident is facing similar 
difficulties with management. And finally, the Department of 
Health and Human Services did not have any department-wide 
policies or guidelines governing the conduct of sensitive 
studies related to radiation health effects research, even 
though its agencies now perform many of those studies for the 
government.
    Once again, it would appear that the government has dropped 
the ball in this case, and citizens who were unknowingly or 
unwillingly exposed to fallout are again victims of 
unacceptable bureaucratic indifference or neglect.
    NCI's work on the I-131 report is a case study on how not 
to manage this type of research and a strong reminder we have 
to constantly work at cultivating openness and public 
participation in this area. I would add that when Congress or a 
committee or individuals are given assurance that a research 
project is being carried out, then it should be expeditiously 
brought to the fore when the information is ready and should be 
brought out just as fast as we possibly can.
    Again, I want to reiterate that today's hearing is not an 
attempt to evaluate the science underlying the I-131 report. 
This morning I hope we can understand why it took so long to 
get the report out; second, get a better handle on whether or 
not the NCI report meets the congressional mandate it was 
given; and third, see what HHS is doing and will do to address 
the problems with the Chernobyl study to ensure consistent 
application of openness and public participation through the 
Department in future studies of radiation health effects.
    In sum, I hope this hearing will be one more step toward 
making government more accountable, open and trustworthy of the 
faith of the people of this country.
    I want to thank you, Madam Chairman, for allowing the 
Minority to pursue this investigation. We are sorry that the 
leak occurred. That should not have occurred from whatever 
source. There was distribution, as I understand it, of this 
material earlier, and we can discuss that privately later on. 
We are looking into it ourselves.
    So I look forward to hearing from the witnesses this 
morning and hearing their testimony.
    Senator Collins. Thank you, Senator.
    Our first witness this morning is the distinguished Senator 
from Iowa, Senator Tom Harkin. I want to commend him for both 
his personal and professional commitment to this issue. He has 
been a real leader, along with Senator Arlen Specter, and we 
very much appreciate his making the time today to come and 
share his knowledge with us.
    We do have a large number of witnesses, so I would ask, if 
you could, that you limit your comments to about 10 minutes. 
Thank you.

TESTIMONY OF HON. TOM HARKIN,\1\ A U.S. SENATOR FROM THE STATE 
                            OF IOWA

    Senator Harkin. I will try to be more brief than that.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Harkin appears in the 
Appendix on page 6.
---------------------------------------------------------------------------
    Madam Chair, thank you very much and, Senator Glenn, again, 
thank you for your kind comments, and thank you for holding 
this hearing. I think it comes at just the right time, and it 
is covering an issue that I think is of vital importance to all 
Americans. Maybe it is not the biggest news story today, but it 
is one that I think is going to affect a lot of people's lives 
in this country. So your hearing just couldn't be more timely.
    Madam Chair, again, I thank you for holding this hearing. I 
think both you and Senator Glenn really covered it. I don't 
know that I can add too much more than perhaps just to 
reinforce a couple of things that you said.
    I think both of you hit it just right. It has to do with 
responsibility and what is the responsibility of the Federal 
Government at this time. The lack of a medical warning and 
response to the nuclear weapons testing of the 1950's and 
1960's was a huge failure of our government. Again, Senator 
Glenn is right that it is 20/20 hindsight. Of course, we were 
living in a different time, a different era, in a Cold War; 
but, nonetheless, the government still can't escape the 
responsibility that we have today.
    Unfortunately, the lack of response seems to be continuing, 
and despite some efforts by the NCI and the Institute of 
Medicine, during the past year, I am afraid, the Federal 
Government's response is still woefully inadequate.
    I might just say as an aside, I think that Senator Glenn's 
bill, the one about the right to know and the right to have 
full knowledge and informed consent before any experiments are 
done on you or you are involved in any experiments is really 
the right thing that we should do at this time.
    As you mentioned, Madam Chair, I do have a somewhat 
personal interest in this, and I will tell you how I got 
involved. Last year, a little over a year and 4 months ago, my 
next oldest brother died, at a fairly young age, of thyroid 
cancer. And, of course, when he came down with it, I had 
already had thyroid problems of my own preceding that by a few 
years. I just thought that was quite unusual, and, when he came 
down with thyroid cancer, of course, it was considered not 
life-threatening. Usually, thyroid cancer is one of those that 
can be handled. But his had been detected way too late. It had 
already metastasized. He fought it valiantly for about, oh, I 
think going on almost 10 years and finally succumbed to it last 
year.
    During that period of time, I began to look more and more 
at the incidence of thyroid problems in this country, and what 
I found was really alarming. I found, for example, Senator 
Glenn, about the use of Synthroid, which, as you know, takes 
the place of the thyroid hormones--I have been on Synthroid now 
for about 18 years. But the use of it over the last decade, 
decade and a half, has just shot up precipitously. I asked the 
question, either one of two things, either doctors are over-
prescribing it or there is something going on out there. I 
don't think doctors are over-prescribing it. It doesn't seem to 
me like a highly profitable drug or anything like that, but 
doctors are detecting more and more thyroid problems. If you 
look at the chart on the use of Synthroid, it has just 
skyrocketed.
    Well, that kind of alarmed me, and then what happened to my 
brother, and then I looked at how much research was being done 
on thyroid cancer. And, of course, since it is a slow-acting 
cancer and not too many people succumb to it--the survival rate 
is fairly high, More interest was focused on breast cancer, of 
course, and colon cancer and lung cancer, things like that. But 
I found out there just wasn't anything being done about thyroid 
cancer. So I began working through my capacity, with Senator 
Specter, on the Appropriations Committee and asking questions 
about the research into it.
    Well, just about that time, this study lands in our lap, 
and you can imagine how startled I was to see the 
juxtaposition, of how these two things come together at the 
same time. And so I looked at the study and looked at the map, 
and, of course, what I saw startled me as much as it did you, 
Madam Chair, when I saw that Iowa, of all places, had a lot of 
radioactive hot spots.
    I then began a process of talking to scientists and others 
and found out that when the nuclear explosions happened in 
Nevada, a lot of the Iodine-131 would get in the upper 
atmosphere, would float along through the jet stream, and then 
it would come down. It would come down at different places, so 
you would find a kind of patchwork across the country, and that 
is why you find some hot spots, for example, up in Maine.
    The next thing I found out was that during the 1950's--and 
you might want to explore this a little further, again, for the 
basis of having some history on this. During the 1950's, Kodak, 
which is located up in Rochester, New York, had been noticing 
that some of the films that they were sending out were being 
clouded. Somebody figured out it always happened around the 
time of a nuclear test. So they got a hold of the AEC. The AEC 
agreed to warn them beforehand when they were going to conduct 
a nuclear test. Therefore, they would protect their film, and 
they wouldn't send it out. Then they would wait a while, and 
then send it out.
    I thought, my gosh, if they could inform Kodak, why 
couldn't they inform the dairy farmers and the people that 
lived in my area and your area, places like that, to not drink 
the milk for a while or don't let the cows graze for a while on 
the grass. Iodine-131 does decay, and so you could--the half-
life is not that long, so you could wait a while, given some 
information. So Kodak got the information. The American people 
didn't.
    So all of this led me to think that we just really had to 
do something. I don't know why the study took so long. You will 
look into that. I would agree with you; from my perusal of it, 
I really do think the science is good. I have no quarrel with 
the science and what they did on this study. I just have a 
problem with the time and the release of the information.
    Just a couple of other items I would mention to back up a 
little bit what you both said on the Iodine-131. A lot of these 
hot spots were identified as receiving 5 to 16 rads of Iodine-
131. You ought to put that in perspective. The Federal 
standards for nuclear power plants require that protective 
action be taken for 15 rads.
    To further understand the enormity of the potential 
exposure, they estimate 150 million curies of Iodine-131 were 
released by the aboveground nuclear weapons test, three times 
that from Chernobyl.
    These hot spots, as you know, were all over the place, and 
as you said, Madam Chair, the most affected were children 
because their thyroids were smaller, they drank more milk. In 
my brother's case, he lived in Pennsylvania at the time, so 
they said, well, OK, here is someone who had thyroid cancer, 
but he didn't live in a hot spot. Well, he sure did when he was 
a kid. And that is what we drank, Senator Glenn. We drank cow's 
milk. And we didn't pasteurize it, either. We just put it 
through a cloth and drank it, and that was it in those days.
    And so you look back, and you wonder how many people there 
are that have moved out of those areas or lived in those areas, 
maybe living in the cities, and have no idea that they were 
ever exposed to any of this.
    So that is why, when I hear the NCI say that, on average, 
everyone is OK. I don't think this is one place where we can be 
satisfied with saying, well, the average is OK. We have got a 
lot of people out there who were exposed, and as you know, 
these things take a long time to develop. And if you look, 
again--I think--I am not on real solid ground on this, but I 
think the incidence of the use of Synthroid is affecting the 
age population about my age, 50's and early 60's, someplace in 
there, who were kids at that time, if you look at the 
incidence. I am trying to get a better handle on that, but my 
first look at it seems to be that that is so. So I think that 
we have a responsibility to get this information out and inform 
them of the risks.
    Now, I have a problem--and I know you will look into this, 
and I hope you do--about the IOM saying that no screening 
should take place. I am concerned about that. I am not a 
doctor, but I do have a problem with this. I think it needs to 
be examined very closely. According to American Cancer Society 
information, the NCI is wrong to oppose screening. Why they are 
opposing it, I don't know. It just seems to me that they are 
saying, well, people will get excited and maybe they will do 
things that they don't have to do. And as I read some of the 
report, I was concerned about that attitude, that, well, people 
might go in and get check-ups or do things that they don't have 
to do.
    And there is one part of the report I just drastically 
disagree with, and I don't have it right in front of me, but it 
was that you could wait; that it didn't make any difference how 
soon you detect thyroid cancer, you could wait a little bit 
later, it was not that big of a problem up front.
    Well, I can tell you from my brother's experience that this 
is nonsense. Any cancer, the earlier you detect it, the earlier 
you take steps to control it, it means your survival rate is 
going to be increased by that much. So I just don't buy that, 
and I don't understand how they came up with that kind of a 
conclusion, that they didn't have to be worried about people 
coming in early, they could wait and just catch it during the 
normal course of getting physicals. But there are a lot of 
people out there without health insurance that don't come in 
for annual check-ups, and I will bet you there are a lot of 
times where you get annual check-ups, and they don't check your 
thyroid. I just wonder how many--mine was just caught. I was in 
the military. I have taken physicals every year of my life, and 
all of a sudden, 1 year I happened to take a physical, and the 
doctor just said, ``There is something wrong with your 
throat.'' And it had been there before. I mean, it didn't just 
happen in 1 year. One doctor happened to catch it, and then 
with some MRIs, we were able to get a better handle on it.
    But there are a lot of people out there who don't have 
health insurance. They don't come in for their annual 
physicals. And I believe information needs to be gotten out to 
these people and to say that if you lived in certain areas and 
you were a child, you ought to get in and have your thyroid 
checked. That is all I am saying.
    Again, I am not here to condemn the scientists. I think 
that they have done a good job on the science, but I do think 
they did an inadequate job in responding to the human health 
consequences of the fallout exposure.
    Again, we are dealing with real people. We are not dealing 
with just averages. We are dealing with people out there that 
need this kind of information. I think the medical community 
needs the information, too, and I think doctors who give 
physicals and our community health centers around the country 
ought to be given this information. That would be a massive 
flow of information from the government to consumers, to the 
health professionals, community health centers all over this 
country to make sure they check on the thyroids of people, ask 
them where they lived when they were kids. Ask them about the 
milk they consumed and things like that. And in that way, I 
think we can do a much better job and fulfill our 
responsibilities more adequately.
    Madam Chair, if I could, I would just like to ask consent 
that a statement prepared by the Physicians for Social 
Responsibility who examined the issue be made a part of the 
record.\1\
---------------------------------------------------------------------------
    \1\ See Exhibit 4, which appears in the Appendix on page 746.
---------------------------------------------------------------------------
    Senator Collins. Without objection, it will be.
    Senator Harkin. And I thank you again for giving me this 
opportunity to testify. I would be glad to try to answer any 
questions if I can.
    Senator Collins. Thank you very much for your testimony.
    Senator Glenn, do you have any questions?
    Senator Glenn. Just very short. You mentioned Chernobyl. 
That was interesting. I hadn't heard those figures before on 
comparison of our total fallout from that and Chernobyl, which 
brings up the international aspect of this whole thing and 
whether these things are all cumulative, wafting around the 
world on jet stream winds and coming down all over the place. I 
don't know whether you have looked into that any further as to 
whether when we were doing our testing, or other people were 
doing their testing, that we were monitoring or were able to 
monitor or even have any record of what the fallout was around 
the world in different places, whether it is the southern part 
of Africa or northern Russia or whatever. I don't have any idea 
what the answer would be.
    Have you seen any studies on that?
    Senator Harkin. I haven't, Senator Glenn. I just asked my 
staff. They haven't seen any, either. And I would think 
Chernobyl being where it is located, and we know the jet stream 
goes from west to east, prevailing winds, you would probably 
have to look in that direction. But obviously some of that 
could have reached us, too.
    Senator Glenn. You have a half-life on this iodine, of 
about 8 days. I don't know about the effects of Chernobyl--it 
may not have had that much effect on us here, but I think the 
overall--I am just thinking of the overall testing programs 
different nations had going back at that time.
    I don't want to spend a lot of time on it. I am just 
curious about it. I hadn't really thought of that before.
    Senator Harkin. No, I hadn't--well, I had thought about 
Chernobyl. I just didn't know. But I don't know if any 
investigations have been done or not. But you are right about 
the half-life, and I think they need, what, something like 2 or 
3 or 4 half-lifes before there is not any real problem.
    Senator Glenn. The normal half-life is about 8 days, and it 
goes down from there?
    Senator Harkin. Yes, I think it is like 30 days total. 
After about 30 days, I think, something like that. You can ask 
the experts, but I think that it is something about that, where 
it just won't affect you any longer. But you are right, 
Chernobyl gets in the jet stream, 2 or 3 days it is here.
    Senator Glenn. But that would take it out across not only 
what is now Russia, the old Soviet Union, but Japan, Korea, 
other nations of the Far East, maybe even winds down into India 
or places like that on occasion. It would be interesting to see 
whether anybody through the World Health Organization or anyone 
has done any studies of the overall effect of iodine and other 
fallout.
    Senator Harkin. You might ask the people--I don't know the 
answer to that question.
    One other thing Senator Glenn, Senator Specter and I have 
put into the appropriations bill a provision that I would like 
to draw your attention to, to do some further studies on other 
radionuclides that were involved in those tests. We don't know 
about those, either. There are other radionuclides--cesium, of 
course, and we know about the strontium, plutonium, and we 
don't even have a handle on what happened to that kind of 
fallout.
    Senator Glenn. Not to delay this, Madam Chair, I know we 
have a number of witnesses, but we did extensive studies on 
some of the downwinders out of Hanford, Washington, when some 
gases were released there that got into some of these other 
areas also. This Committee in particular has followed that 
through the years and done a lot of work in that area, too. So 
it all combined into a big picture. People need to know more 
information in a timely fashion just so they could have an 
annual screening if they were in a hot spot for example, or 
could watch out for symptoms in their children.
    Thank you, Madam Chair.
    Senator Collins. Thank you, Senator Glenn. Thank you, 
Senator Harkin.
    Senator Harkin. Again, thank you, Madam Chair, for 
conducting this hearing. It is vitally important.
    Senator Collins. Our next panel of witnesses consists of 
Dr. Owen Hoffman and Dr. Barry Johnson, who will testify about 
the significance of the NCI's findings on the radiation 
resulting from nuclear weapons testing.
    Dr. Hoffman, a scientist who served as a consultant to the 
NCI study, is currently president of SENES Oak Ridge, Inc. in 
Tennessee. Dr. Johnson is the Assistant Administrator of the 
Agency for Toxic Substances and Disease Registry. That agency 
is part of the Department of Health and Human Services and is 
responsible for conducting medical studies, registries and 
monitoring.
    Pursuant to Rule 6 of the Subcommittee, now that you all 
are comfortably seated, I would ask that you stand and be sworn 
in.
    Please, raise your right hand. Do you swear that the 
testimony that you are about to give is the truth, the whole 
truth and nothing but the truth, so help you, God?
    Dr. Hoffman. I do.
    Dr. Johnson. I do.
    Senator Collins. Dr. Johnson and Dr. Hoffman, there is a 
third person at the panel. Could you, for the record, identify 
him, please?
    Dr. Johnson. Madam Chair, I am accompanied today by Dr. 
Jeffrey Lybarger, who is the Director of our Agency's Division 
of Health Studies.
    I may refer to him on issues of technical issues, if that 
arises during the testimony.
    Senator Collins. Thank you. We look forward to hearing from 
each of you today. Your written testimony will be made a part 
of the record but in order to allow ample time for questions 
and answers, we are going to limit your oral testimony to about 
10 minutes each.
    We are going to be using a timing system this morning. You 
will see right in front of you three lights. The green light 
will signify the beginning of your 10-minute period. About 1 
minute before the 10-minute period is through, it will turn to 
yellow, which will encourage you to wrap up your testimony and 
make your final points.
    But I do want to emphasize that your entire prepared 
testimony will be in the record.
    Dr. Hoffman, we will start with you this morning.

TESTIMONY OF F. OWEN HOFFMAN, PH.D.,\1\ PRESIDENT AND DIRECTOR, 
SENES OAK RIDGE, INC., CENTER FOR RISK ANALYSIS, AND CONSULTANT 
 TO THE NATIONAL CANCER INSTITUTE'S STUDY, OAK RIDGE, TENNESSEE

    Dr. Hoffman. Thank you, Madam Chairman.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Hoffman appears in the Appendix 
on page 48.
---------------------------------------------------------------------------
    The Subcommittee has requested that I testify today about 
two primary issues. The first being my views on the overall 
health impact to the American people from atmospheric testing 
of nuclear weapons at the Nevada test site, and the second 
being my personal involvement with and observations about the 
overall production of the National Cancer Institute's report, 
its conduct of research on the topic and including an 
interpretation of the results of the National Cancer 
Institute's Iodine-131 study.
    My professional training is as an environmental scientist. 
I have more than 25 years of experience in the field of 
environmental radioactivity. During my career, I have devoted 
considerable effort to the study of the environmental transport 
and health consequences of Iodine-131 and other radionuclides.
    In 1987, I performed experimental research for the National 
Cancer Institute to produce information that helped confirm 
some of the assumptions that were made in this study. I also 
served over a period of years as an unfunded consultant to 
advise on methods for the analysis of uncertainty in the 
National Cancer Institute's dose estimates.
    I would like to also point out that I have served as chief 
scientist to the International Atomic Energy Commission on the 
use of Chernobyl data to actually test the accuracy of 
environmental models and, indeed, the Chernobyl fallout went 
around the world. We even measured it here in the United 
States.
    What are the most important findings of the National Cancer 
Institute's report? I would like to point out that it makes 
comprehensive estimates of the thyroid dose resulting from each 
of 100 atmospheric tests held in Nevada during the 1950's. In 
all, approximately 150 million curies--not 116--but 150 million 
curies of Iodine-131 was released to the atmosphere from the 
Nevada test site. Now, this is about 3 to 4 times the amount 
released from Chernobyl. You had an earlier estimate of that 
release. I would like to correct it. It is 45 million curies, 
not 7 million curies of Iodine-131 that was released from 
Chernobyl.
    The National Cancer Institute report estimates doses of 
radioactive iodine that was received by individuals of various 
ages and who consumed various dietary sources of fresh milk for 
over 3,000 counties in the Continental United States. Let me 
make this point and let me make it clearly, that this is the 
largest and most extensive dose reconstruction ever carried out 
in the United States. Presently, there are dose reconstructions 
ongoing at Fernald, Ohio, at Hanford, Washington, at Oak Ridge, 
Tennessee, at Savannah River, Georgia, and at Rocky Flats, 
Colorado. Compared to all of these sites, the NCI dose 
reconstructions is the big one.
    Iodine-131, as mentioned previously, is one of many 
radionuclides released in fallout. It is because of its 
affinity to rapidly deposit on vegetation and to be accumulated 
into food chains, especially the milk food chain, and then to 
affect the thyroids of children, is why it gets so much 
attention. Iodine-131 is not the only radionuclide in fallout; 
however, the NCI study was mandated by Congress to focus only 
on Iodine-131.
    The other thing I would like to mention is that the plumes 
from the Nevada Test Site went beyond the borders of the United 
States. The NCI study, however, was restricted to just the 
doses to the American people and, as far as I know, the overall 
effects of the Nevada Test Site fallout in our neighboring 
countries has not been assessed.
    The primary population at risk would be those in childhood 
at time of exposure. It was mentioned previously that the 
plumes went throughout the United States. It has also been 
mentioned previously that an initial estimate of health risk 
ranged from 11,000 to 212,000 excess cases of cancer. I would 
like to point out that those estimates would primarily be 
manifested in children, who were under the age of five at time 
of exposure and who are primarily females. And the majority of 
those cases would occur for people living in the Midwest and 
Eastern United States because that is where the population is.
    So, even though the so-called hot spots appear to occur in 
the West, the population base is rather small so the overall 
cases of cancer that was manifested in the West would be small 
compared to the consequences that would have occurred in the 
eastern United States.
    For children born in 1952 and for children consuming either 
above-average quantities of commercial milk or unpasteurized 
milk from local sources, such as a family cow, backyard cow or 
a local farm, the National Cancer Institute estimates that 
there are approximately 270 counties in the United States where 
the median or central estimates of thyroid doses would have 
reached above 30 rads and nearly 2,500 counties where the 
central estimates of dose would be between 10 and 30 rads.
    Those dose estimates well exceed any past or current 
radiation protection guides dealing with maximum dose limits to 
the thyroid. They also exceed emergency reference levels, which 
are recommendations for taking action, either recommending that 
cows not be fed fresh feed or banning milk from the market.
    The World Health Organization currently is recommending 
that at doses that can be averted as high as 1 rad, that stable 
iodine tablets be distributed in order to block thyroid uptake 
of radioactive iodine. The current recommendations of the Food 
and Drug Administration and the EPA recommends this procedure 
at 25 rad. So, these dose estimates from exposure to NTS 
fallout approach and exceed emergency levels for those who were 
in childhood at time of testing who were consuming above-
average amounts of milk or milk from local sources.
    Another measure of comparison is looking at risk limits for 
Superfund sites. Now, at Superfund sites the need to clean up 
is triggered when risks are in the range of 1 chance in a 
million life-time health risk of cancer up to 1 chance in 
10,000 for maximally-exposed individuals. Usually when it 
exceeds 1 chance in 10,000, the need for clean up is taken 
seriously.
    I would like to point out that for children under the age 
of 15, a life-time risk that would approach or exceed 1 chance 
in 10,000 of an excess risk of thyroid cancer would be on the 
order of just 1 to 2 rad. And the risk would increase in a 
multiplicative fashion for every rad increase beyond that.
    So, that concludes a brief summary of the significance of 
the study. Now, another question that I have been asked to 
answer is, have the important findings and their significance 
been adequately conveyed to the public by the NCI? To answer 
this, I offer to you an opinion. The information in the report 
is extensive. It is of the highest technical quality. There 
have been numerous presentations made in the past to scientific 
committees but, I would contend that, no, the information is 
not readily accessible to people who are non-technically 
trained and who have an interest in this topic.
    And the reason for this is that the executive summary of 
the report focuses mainly on average doses. The average dose is 
controlled by the majority of the population who were adults at 
time of exposure and the risk to those individuals is very 
small. The risk to the U.S. population is controlled by those 
who were in very young childhood and who were consuming large 
amounts of milk.
    One has to go into the appendices of the report, into 
Section 8, and start combing through the maps in the back of 
the report before one obtains a full appreciation as to how 
high these doses could have been. And, in fact, if one really 
is interested in discerning how high the doses could have been, 
it is necessary to get into the NCI web site and actually begin 
to put in information about dietary habits and date of birth in 
order to get quantitative information that would be pertinent 
to the interest of any individual.
    Now, I would like to just finish with a personal 
recommendation. That is I think we would not be here today if 
the National Cancer Institute had adopted the same commitment 
to openness and public involvement as is now the standard 
practice in dose reconstruction studies that are currently 
taking place throughout the United States. Those studies are 
being conducted by the Centers for Disease Control and by 
various State Departments of Health.
    Had there been public outreach and a commitment to 
openness, I do not think the NCI report could have been 
delayed, and I think that the report would have been consistent 
with its full mandate; which is: To include estimates of health 
risk. I think one of the main reasons why it is difficult for 
members of the public to understand the information in the NCI 
report is because, contrary to the Congressional mandate given 
in 1983, there are no estimates of health risk.
    It is not like openness is anything new. Members of NCI and 
I have had these discussions at least over the last 8 years, 
but it is only recently as a result of, I would say, tremendous 
media pressure as of last summer that the report was published. 
Since publication, however, there has been, as far as I can 
see, every attempt made by NCI to answer all questions posed to 
it.
    That concludes my presentation, and I am happy to answer 
any specific questions that you have.
    Senator Collins. Thank you very much, Dr. Hoffman.
    Dr. Johnson.

  TESTIMONY OF BARRY L. JOHNSON, PH.D.,\1\ ASSISTANT SURGEON 
 GENERAL, ASSISTANT ADMINISTRATOR, AGENCY FOR TOXIC SUBSTANCES 
AND DISEASE REGISTRY, PUBLIC HEALTH SERVICE, U.S. DEPARTMENT OF 
  HEALTH AND HUMAN SERVICES; ACCOMPANIED BY JEFFREY LYBARGER, 
           M.D., DIRECTOR, DIVISION OF HEALTH STUDIES

    Dr. Johnson. Madam Chair, Senator Glenn, good morning. I am 
the Assistant Administrator of the Agency for Toxic Substances 
and Disease Registry (ATSDR). I am accompanied today by Dr. 
Jeffrey Lybarger, Director of our Division of Health Studies.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Johnson appears in the Appendix 
on page 61.
---------------------------------------------------------------------------
    At the request of the Subcommittee, our testimony today 
will address ATSDR's medical monitoring responsibilities under 
the Comprehensive Environmental Response Compensation and 
Liability Act known as CERCLA or Superfund.
    In particular, we will describe ATSDR's finding that 
medical monitoring of persons exposed to radioactive iodine 
released in the past from the Hanford Nuclear facility in 
Richland, Washington, is called for under CERCLA. Our testimony 
also relates the public health approach taken by ATSDR in 
considering CERCLA's medical monitoring provisions when 
populations have been exposed to hazardous substances released 
into the environment.
    Further, at the Subcommittee's request because the 
Institute of Medicine recently recommended against thyroid 
cancer screening, we will highlight our differences in decision 
making and why we continue to support our decision for a 
medical monitoring program for a sub-population of well-defined 
persons exposed as children to Iodine-131 released from the 
Hanford facility.
    ATSDR interprets its CERCLA language on medical monitoring 
as an important public health intervention that provides early 
diagnostic and referral services for a well-defined 
population's health risks.
    Early detection of a change in health status is the most 
effective way to lessen the burden of more advanced disease and 
enhances survival. ATSDR's public health approach for 
considering a population for medical monitoring involves a 
rigorous process that applies established medical monitoring 
criteria for a specific site, using a multidisciplinary panel 
of experts to apply and assess the criteria, assures 
independent and external peer review on all matters of science, 
that will support an involvement of affected stakeholders 
certainly including the affected public, reviews risks and 
benefits as part of a formal agency approval process, 
implements medical monitoring activities when indicated, and 
periodically evaluates the medical monitoring program for 
effectiveness and quality.
    In 1995, ATSDR commenced a deliberative process to 
determine if medical monitoring was warranted for persons at 
increased risk of thyroid cancer and other conditions from 
exposure to Iodine-131 released from the Hanford Nuclear 
Reservation during the period 1945 through 1951. A dose 
reconstruction study had documented large releases of Iodine-
131 into the atmosphere and provided dose estimates of 
representative individuals according to their age, and where 
and when they lived, within a large geographic area surrounding 
Hanford.
    From these data, ATSDR determined that the major public 
health risk is among young children downwind of the facility 
who consumed Iodine-131 contaminated milk during the period 
1945 through 1951. Early in our efforts, ATSDR and CDC jointly 
formed the Hanford Health Effects Subcommittee to advise the 
agencies on their research and public health activities related 
to the Hanford facility. This committee comprises of 21 persons 
who represent community, business, government and other 
interests. Our meetings are held on a quarterly basis, in 
public, and generate considerable media attention that further 
promotes public awareness and education.
    We also work closely with the Intertribal Council on 
Hanford Health Projects which includes representation from nine 
tribal nations in the Hanford region. The HHES, the 
Subcommittee which I referred to, provides an essential 
resource for expressing health concerns from communities and 
tribal nations. This committee reviewed ATSDR's approach to and 
findings from the consideration of the medical monitoring 
program.
    In consultation with an expert panel, we determined that a 
median 10 rad or higher thyroid dose for children would place 
these individuals at significant increased risk of thyroid 
disease as adults. This was based on the extensive medical 
literature of external radiation exposures that support 
elevated thyroid cancer risk at this dose level or higher among 
children. These elevated thyroid cancer risks occur for many 
decades following radiation exposures to the head and neck in 
children.
    Moreover, there is an increasing amount of medical 
literature that supports a reasonable association between 
radioactive iodine exposures and excess occurrences of thyroid 
neoplasms. This literature includes published studies of 
populations exposed to the Chernobyl fire in 1986, Marshall 
Islanders exposed to the 1954 BRAVO test releases, school 
children exposed to the Nevada Test Site atmospheric testing 
releases during the period 1951 through 1962, and preliminary 
findings from the Hanford Thyroid Disease study.
    Our analysis estimates that 14,000 people, the majority of 
whom were exposed in 1945, would have received a sufficient 
thyroid dose of Iodine-131 as children to place them at 
significant risk of thyroid cancer and other thyroid and 
parathyroid conditions. Because there is no randomized 
controlled study proving the benefits of thyroid cancer 
screening, ATSDR conducted a prevention effectiveness analysis 
to project the potential harms and benefits of a program based 
on a clinical decision model. The prevention effectiveness 
analysis also allowed us to project which benefits and which 
harms might result from various medical monitoring scenarios.
    Clearly, a well-defined high-risk population must be 
identified for a program with thyroid evaluation to derive the 
most benefit. The geographic precision of the radiation dose 
estimates from the Hanford releases was a key in ATSDR's 
prevention effectiveness analysis and helped clearly define the 
at-risk target population. As I indicated 14,000 people we 
estimate.
    Again, the Hanford Health Effects Subcommittee was a very 
valuable resource for discussing risks and benefits attending 
medical monitoring for thyroid disease. After 18 months of 
careful consideration and analysis following meetings with 
executive and senior scientific staff and a meeting with 
community and tribal representatives, Dr. David Satcher, as a 
former ATSDR administrator, and Director of the CDC, signed the 
decision memo for medical monitoring on February 7, 1997.
    Now, differences in decision making between ATSDR and the 
IOM report. First, ATSDR is directed under CERCLA medical 
monitoring programs for populations at significant risk of 
adverse health effects from exposure to hazardous substances. 
This represents a different type of public health activity, we 
believe, in the setting of a national policy or standards for 
thyroid cancer screening.
    Second, we perform our work on a site-specific basis using 
the best available scientific and medical information and 
following a rigorous process that is based on our seven 
criteria for medical monitoring. We not only involve the 
affected public in our decision making process, but also 
conduct external scientific peer review of our work to make the 
best public health decision possible.
    By consulting recognized experts on the medical issue under 
consideration and involving the public most directly affected 
by the proposed intervention, our process provides an important 
and necessary balance for public health decision making.
    Third, because we are not setting national screening 
policy, our criteria do not require a randomized control study 
showing the benefits of screening, although, we would certainly 
use such data if available.
    Fourth, we agree with IOM that the current dose estimates 
for U.S. counties have large uncertainties which makes it 
difficult to readily determine who is at highest risk. At 
Hanford, however, we are fortunate that the dose reconstruction 
study estimated doses at a much more precise level of 
geographic resolution: Specifically 6-mile-by-6-mile areas.
    In closing, ATSDR considers medical monitoring of a well-
defined, high-risk population to be consistent with the central 
principle of public health: Prevention of disease as preferable 
to treatment and medical care, and early loss of life. 
Moreover, for maximum effectiveness, prevention efforts must 
involve the public that will be impacted by these public health 
decisions and efforts.
    Thank you.
    Senator Collins. Thank you, Dr. Johnson.
    I am just going to have a couple of brief questions for Dr. 
Hoffman before turning over the questioning to Senator Glenn, 
since this is a Minority investigation.
    Dr. Hoffman, as I mentioned in my opening statement, one of 
the most important findings of the NCI study in my view is the 
fact that contrary to what one might think the fallout from 
these nuclear weapon tests was not limited to areas very close 
to the Nevada Test Site. And you mentioned specifically the 
Northeast and the impact on people born in 1952, which was the 
year I was born. So, this is of some personal interest to me.
    I would like to, just briefly, illustrate the effect of the 
prevailing winds, look at my home State of Maine. There is a 
chart of the entire United States that I believe is part of the 
National Cancer Institute study,\1\ part of the report that 
shows Aroostook County, Maine, where I grew up, as being a 
particular hot-spot where people were exposed to 30-plus rads. 
So, a very high exposure rates. But our charts take a different 
point. They start with January 1.
---------------------------------------------------------------------------
    \1\ See Exhibit 1a, which is retained in the files of the 
Subcommittee.
---------------------------------------------------------------------------
    And what I would like to do, to just illustrate the point 
that you can live very far from where these tests were 
conducted and still there is a significant impact, is have you 
walk us through the charts. The first chart \2\ relates to 
those consumers, primarily children--I assume we are talking 
about--who consume an average amount of milk. I would add that 
I feel like I finally won many years later the battle with my 
mother on drinking milk, but small consolation.
---------------------------------------------------------------------------
    \2\ See Exhibit 1b, which appear in the Appendix on pages 90-92.
---------------------------------------------------------------------------
    Dr. Hoffman, would you walk us through these charts?
    Dr. Hoffman. Yes. What you have here is an excerpt of the 
results that you would find in the appendix of the National 
Cancer Institute's report of October 1997. And what this chart 
shows is that virtually the entire State of Maine would have 
received doses in excess of 3 rads for children who were 
consuming just an average amount of milk and who were born on 
January 1, 1952, with the exception of a few counties, one 
county right in the center of Maine. You know the name of the 
county, I do not.
    Senator Collins. It is Penobscot and Piscataquis Counties.
    Dr. Hoffman. Yes. Where the doses would be in the category 
of 10-to-30 rad for such an individual.
    Senator Collins. I would next like to look at a second 
chart \2\ which relates to consumers who drank a great deal of 
milk and the impact changes rather dramatically in this case, 
it looks like to me. But, again, if you could help us 
understand it.
    Dr. Hoffman. I think that this demonstrates one of the 
strengths of the calculations that have been made in the 
National Cancer Institute's report. In their report they did 
consider the fact that some children would consume much more 
milk than just the average. And, so, they targeted a 
calculation for individuals that would be consuming more than 
just the average amount. And for those you see the doses 
increase quite a bit. Now, in this second chart almost the 
entire State of Maine is impacted with doses ranging from 10-
to-30 rad.
    Senator Collins. And the third chart \2\ I want to show you 
illustrates those who drank a great deal of milk from what we 
call a backyard cow. It could be someone living on a farm, for 
example. Could you comment on this chart?
    Dr. Hoffman. Yes. The reason why the backyard cow is 
important is that there is no dilution from milk transported 
from outside the region. Also, backyard cows tend to produce 
less milk on the total and have the potential for transferring 
more iodine into their milk than the commercial dairy cow.
    And in this circumstance, for people who either are 
consuming milk from a backyard cow or a local farm, the entire 
State of Maine (for individuals born on January 1, 1952), would 
have received doses between 10-and-30 rad.
    Senator Collins. Thank you for that explanation of these 
charts. Just one follow-up question. It occurs to me as I 
listen to Senator Harkin recommending that there be widespread 
screening and then when I read the report recommending that 
there not be widespread screening that perhaps there is a 
middle ground here.
    And that is that if this material were communicated to 
physicians in, for example, the State of Maine, who may not be 
aware of the risk factors and the exposure that occurred during 
the 10-year period in question, that perhaps physicians armed 
with that information could decide whether testing or screening 
was appropriate for their patients. But if they do not have 
access to this kind of information or they are just not aware 
of it, they cannot make those kinds of judgments.
    Do you know--and I will ask the NCI officials this 
question--but has there been an effort to educate the medical 
profession about the rather startling and unexpected findings 
on the dosages of radiation received during those periods?
    Dr. Hoffman. I am not aware of a major educational effort 
at this time. I believe at the time of the release of the 
information that one of the members of the National Cancer 
Institute's Advisory Committee, Dr. David Becker, indeed on his 
own, attempted to educate and make contact with the American 
Thyroid Institute in order to caution the medical community 
about the potential hazards of massive screening.
    This is not to be taken lightly. Screening, if applied 
without due caution, can result in more harm than good.
    Senator Collins. And I agree with that and I am not 
advocating frightening the public into thinking that we need a 
massive screening program. But on the other hand, it seems to 
me that physicians in Maine, for example, treating people my 
age and a bit older who grew up during this period in areas 
that are hot spots, should have this information so that they 
can decide on a case-by-case basis whether or not screening 
might be appropriate.
    Dr. Hoffman. Well, I would like to mention that in my own 
analysis of the data, I do not see as much evidence for hot 
spots as I see evidence for age at time of exposure, gender, 
and especially for those individuals, those rare individuals on 
a diet of goat milk, to determine the high-end exposed group.
    That group will be at more risk than any average group that 
might be associated with a particular geographical location.
    Senator Collins. Thank you, Dr. Hoffman.
    Senator Glenn.
    Senator Glenn. Thank you.
    What is the difference between a backyard cow and a dairy 
cow as far as radiation goes? I do not understand why that 
would be different?
    Dr. Hoffman. Well, dairy cows are managed for maximum 
production of milk and they are often given a much higher 
percentage of concentrates, they may produce upwards of 30 
quarts of milk or about 7 gallons of milk a day; whereby a 
family cow that is set out to pasture to graze may only produce 
from one-third to one-half of that.
    Senator Glenn. In other words, your dairy cow would get 
more supplemental feed that would not be raw grass and things 
like that that are often more exposed to fallout?
    Dr. Hoffman. That is correct. And also because of the type 
of cows usually used for family use are low producers, there is 
a tendency for them to concentrate more iodine into the milk 
than those cows, like the large Holsteins, that are used for 
commercial diary operations.
    Senator Glenn. Dr. Johnson, am I correct to say that you do 
not recommend any overall screening now? Would you go along 
with screening in some of these hot spots where we have seen a 
lot of thyroid cancers develop? Or do we have enough 
information to do that?
    Dr. Johnson. Senator, you are asking me to comment on the 
National Cancer Institute study of which I am not that 
knowledgeable. What ATSDR did with regard to a comparable 
situation where Iodine-131 was released from the Hanford 
facility, we do recommend medical monitoring or, if you wish to 
call it, screening. And that is for persons whom we estimate to 
have had 10 rads or above exposure, primarily 1945-1951. Of 
that 14,000 people, some 60 percent have had exposure to 25 
rads or greater. So, we have recommended under Superfund that 
medical monitoring be done for that group of 14,000 people.
    Senator Glenn. In your studies, when you are reviewing the 
studies did ATSDR take specific steps to involve and inform the 
public and what specific steps did you do?
    What I am looking for really is this also: What do we do 
once we put this out to the public? What does the public do 
with it? We do not want openness just for openness' sake and 
say all wash your hands, everything is great, now, we have 
protected the public. The public has to be given this 
information in some way that means something to them or it is 
sort of academic whether we put it out there or not.
    What did you do to help people get informed on this and to 
take precautions in their own families some way or was there an 
effort like that? If so, describe it.
    Dr. Johnson. I think I would like to begin, sir, by 
indicating that the practice of public health for quite some 
time has involved involvement of communities and tribal nations 
and getting the public involved is now very much a part of the 
fabric of public health.
    With regard to what we did specifically at Hanford, as I 
said in my testimony, we and CDC, jointly, created something 
called the Hanford Health Effects Subcommittee. Twenty-one 
persons representing a broad representation of the community 
around Hanford. State health departments, the business 
community, concerned citizens, etc.
    We began our effort to determine if medical monitoring for 
the Hanford facility should be pursued by discussing that with 
this committee that we formed. The committee for 2 years met 
quarterly. They provided us with information on their health 
concerns, advice on various issues of community education.
    Through that committee we were able to outreach to State 
and local health departments on what we felt were the issues 
related to Iodine-131 released from Hanford. We came to a 
deliberative decision under Superfund that medical monitoring 
should be pursued and that was done in conjunction with this 
committee, with the media.
    And we have tried to educate health care providers, 
principally through working with State and local health 
departments.
    Senator Glenn. Is there any natural occurring Iodine-131 in 
nature? Does it all come from this? Is there any at all from 
lightening or whatever? Is there any natural Iodine-131?
    Dr. Hoffman. It is a product of nuclear fission.
    Senator Glenn. Yes.
    Dr. Hoffman. And, so, to the extent that in the past there 
have been natural nuclear incidents of spontaneous fission, 
that would be the source of materially-occuring Iodine-131. But 
because of its short half-life of 8 days, it would not persist.
    Senator Glenn. One of the things Congress requested was 
that a risk assessment be done by the report, but I do not 
think any was included in the report.
    I understand that National Cancer Institute did a risk 
assessment in 1997 and put it out in a press release. I do not 
know what the extent of that was or what the details were that 
went out. I guess we could say that was some effort at making 
this information available to the public.
    I do not know how extensive that was. But how difficult is 
a risk assessment to do? Should that be a natural outcome of 
this kind of a study?
    Dr. Hoffman. I believe it should. Today in the dose 
reconstructions that are ongoing at Hanford, Rocky Flats, Oak 
Ridge and Fernald, the end point of the study is an estimate of 
individual risk.
    And, so, it was personally surprising to me that risk was 
not aggressively pursued in the National Cancer Institute 
study. The National Academy of Sciences and the Institute of 
Medicine report conclusively state that there is a causative 
link between Iodine-131 and thyroid cancer. This information 
has been reinforced from the experience of the follow-up of 
children exposed from Chernobyl. Yet the very people who are 
most intimately involved in the study of children exposed to 
Chernobyl fallout are the same people involved in the National 
Cancer Institute's Iodine-131 report. So, I do not know why 
information about health risk was not included.
    Senator Glenn. Yes. We are making a major issue of 
openness, as we should, but what happens then when we are open? 
Let us say all the information has been put out, what would the 
State health departments or doctors or AMA, whoever, what would 
they do?
    Is it just a general awareness through the medical industry 
that they ought to be more careful in screening this or is 
there an antidote to this in any way or any protection people 
can take?
    In other words, openness just for openness' sake is one 
thing, but openness to get information out there that people 
will act on and are concerned about, that is very constructive. 
How do we make this effective?
    Dr. Hoffman. Well, yes, you have stated exactly the point 
that I was trying to make. Through openness, the community with 
a need for the information is informed at the earliest stage of 
the project and they have time then to digest the information 
and take appropriate action.
    The information about the high thyroid doses throughout the 
United States, that information perhaps was known as early as 
1965. But in the National Cancer Institute report the first 
preliminary results were available in the late 1980's. In an 
open study that preliminary information would be made available 
and people would have had the opportunity to respond to this 
information.
    Senator Glenn. Do you have any reason that you know of why 
this was not put out earlier? Was it just a delay or other 
things that people were involved with do you know?
    Dr. Hoffman. In my personal opinion, I think it is in part 
a reflection of the traditional scientific process of not 
releasing information until it is absolutely final. And because 
the information was not absolutely final it was not released.
    But contrary to that scientific tradition, present-day 
public health dose reconstructions will release draft results 
at an early stage with the understanding that it is draft 
information and subject to change.
    Senator Glenn. I think you had indicated, maybe in your 
longer written statement or earlier, that you believe the data 
was completed about 1989 and the report was completed about 
1992. That is 8 and 5 years before the report was issued. Do 
you know why that occurred?
    Dr. Hoffman. Well, I would like to just make a correction. 
I do not know if the report was completed in 1992 but I think 
the calculations were finalized about that time. So, the basic 
information was well in hand in that time period.
    Why did it take from 1992 until the present time to release 
the report? I think, you must put that question to the authors 
of the report.
    Senator Glenn. From a practical standpoint, is there any 
easy test for thyroid cancer? If I was concerned about a child 
or a grandchild that had thyroid cancer, is there anything 
except the doctor finding lumps or do you have to go through 
the expensive things like an MRI and things like that to 
determine if there is a problem there? There is no easy test, 
is there?
    Dr. Johnson. Senator, the proposal we made that is specific 
to Hanford is a phased approach where a person would be seen by 
a physician who knows the issues, that is to say, radiation and 
thyroid disease. The first phase of that screening would 
involve palpation of the thyroid, a physical exam, a personal 
history and so forth.
    The second phase of that effort would go into a program of 
ultra-sound if referred into the second phase from the first 
phase. The third phase would be fine-needle aspiration where a 
small amount of tissue from the thyroid gland is examined for 
abnormal pathology.
    Our program would then recommend under conditions that 
knowledgeable physicians then make the decision on whether or 
not to proceed with surgery or some other kind of more invasive 
procedures.
    So, we see it as a phased diagnosis.
    If I could comment also with regard to physicians. Our work 
with State health departments leads to work with local health 
departments, that leads to work with local medical societies, 
that leads to work with local health care providers. And it is 
a process that has to involve all those links--State, local, 
medical societies, local health care providers. Physicians are 
not well versed on issues of toxicology, radiation biology and 
so forth. And I do not think the public should expect that that 
should be the case.
    Our responsibility is to provide that technical assistance 
and to provide other information that would be helpful in their 
practice of medicine.
    Senator Glenn. Well, but you still depend on what? On 
things like AMA publications or do you have a report that you 
put out to every registered doctor in the United States?
    Dr. Johnson. Again, we work under Superfund. It is a site-
specific individual issue. For example, we recently had concern 
about PCBs and fish tissue. We worked with the USEPA to 
outreach to every physician in one particular State in the 
Midwest. It is not Ohio, sir. It was one of the other States. 
So, it depends upon the issue.
    Senator Collins. Senator Glenn, I can yield the remainder 
of my time to you or we could go to Senator Durbin?
    Senator Glenn. I yield to Senator Durbin.
    Senator Collins. Senator Durbin.

              OPENING STATEMENT OF SENATOR DURBIN

    Senator Durbin. Thank you, Madam Chair.
    I appreciate this hearing and I am learning a lot in a 
hurry about a subject that I do not profess to have any 
particular expertise. I am trying to really translate this into 
what I might expect the average person in my home State of 
Illinois to ask me if they should hear about this hearing and 
this report. Particularly when I look at one of the charts--and 
I am not sure you have them for all the States there, but you 
have provided them for us in the testimony--and I find that one 
of the communities near where I live, Christian County, 
Taylorville area, supposedly had exposures of greater than 30 
rads of Iodine-131 thyroid doses for persons born on January 1, 
1952, the backyard cow example.
    What am I to tell someone who heard that, that this was the 
case? What kind of precaution or concern should they have over 
that fact, if they lived in that area in that period of time?
    Dr. Johnson. Well, Senator, again, my agency is involved 
with releases of Iodine-131 from the Hanford facility so our 
work is not specific to the National Cancer Institute study, 
although there are parallel issues.
    What we have said to the public that was exposed as 
children to Iodine-131 releases working through the media--
working through the States of Washington's, Idaho's, and 
Oregon's health departments--that exposure does increase their 
risk for certain kinds of thyroid disease.
    We have said that we believe this is a matter between 
persons and their health care providers and their physicians 
and that we are trying to provide that would outreach to those 
persons at elevated risk to bring them in for a kind of 
screening program.
    Senator Durbin. Is there a normal period of time within 
which you could expect this thyroid cancer to exhibit itself? 
If a person said, OK, I was living at Taylorville, I grew up 
there, I was a kid born in 1952, I am 46 years old, I have 
never had a problem, does that mean I am out of the woods when 
it comes to this particular concern? Or is it, no, you have 
just reached an age where it might be a particular concern?
    Can you tell me that?
    Dr. Johnson. I would like to refer that to my colleague, 
Dr. Lybarger, who is a medical doctor.
    Dr. Lybarger. Senator, the risk increases throughout one's 
lifetime to a general level of around 40 years. It does not 
decrease after that period of time. So, generally, it is a 
life-long risk of extra cancer.
    Senator Durbin. Can I ask you about some other things, too. 
Dr. Hoffman testified that Iodine-131 is just one of the 
radionuclides--I hope I am pronouncing that correctly--that 
occurs in fallout, but it is the one that has been the subject 
of the largest dose reconstruction study.
    Are there other dose reconstructions of other radionuclides 
that ought to be conducted?
    Dr. Hoffman. I believe so. There have been assessments of 
the impact of all the radionuclides in global fallout from the 
United Nations Scientific Committee on the Effects of Atomic 
Radiation. But a detailed assessment on the level of the 
National Cancer Institute's report for other radionuclides, 
beyond those communities immediately downwind of the Nevada 
Test Site, has never been done.
    Also, there has not been an attempt, as far as I know, to 
estimate the individual risk associated with exposure to those 
radionuclides. Now, what I think is important, and the reason I 
would support such studies, is because the types of cancers and 
disease induced by exposure to those other radionuclides are 
more likely to result in a fatality rather than just a 
morbidity.
    In the case of thyroid cancer mortality is less than 10 
percent. The leathality fraction, or the chance of death, is 
much higher for the types of cancer induced by the other 
radionuclides.
    Senator Durbin. I do not want to over-state what you have 
just said so I want to make sure it is clear for the record. 
You are suggesting that this study with Iodine-131 indicates 
what probably occurred as a result of the fallout from the 
tests in creating a medical condition which is serious but not 
as life-threatening as some other cancers.
    And you are saying that there are other radionuclides that 
might have come from these tests which should also be surveyed 
because of the potential danger which might be even greater 
than the danger of thyroid cancer, is that correct?
    Dr. Hoffman. That is correct. But I would say that there 
are other radionuclides that did come from these tests, not 
might have, they did. And I personally have asked this question 
of the National Cancer Institute in the past and that is, why 
was there no attempt to expand the scope of the study? I feel 
the intent of that public law back in 1983 was to look at the 
full potential health impact of weapons testing at Nevada. To 
do that, you have got to look at all the radionuclides.
    Now, the techniques that were developed to estimate Iodine-
131 are the same techniques that could have been used to 
estimate all of the other radionuclides. So, the step to 
include an estimate for the other radionuclides in fallout was 
not a major step.
    Senator Durbin. What are the other radionuclides? Can you 
tell me? Is the list too long?
    Dr. Hoffman. The other ones are Cesium-137, that has a 30-
year half-life and is readily taken up in the food chains; 
Strontium-90, that acts very much like calcium and is taken up 
like iodine into milk and can deposit in bones. Over the long-
term, radioactive Carbon-14, which also will be prevalent in 
human foods. Those three radionuclides can be measured even 
today.
    However, the bulk of what can be measured was contributed 
by global fallout, not by Nevada Test Site operations.
    Senator Durbin. Can we use the same--let me see if I state 
this correctly--I take it what you have given us in this 
portrayal here and map, as Senator Collins and others have 
noted, is an indication of where these deposits of Iodine-131 
were the most serious or the greatest. Can we conclude that 
these other radionuclides were likely to have been deposited in 
the same places?
    Dr. Hoffman. Yes.
    Senator Durbin. We can.
    Dr. Hoffman. Yes.
    Senator Durbin. Well, then I think what--I do not want to 
over-state this--but I think what we are considering today is 
the canary in the cage in the coal mine and it is looking very 
sick because of Iodine-131 and something worse may be out 
there. And I am afraid that--and I do not want to over-state 
this because this is a serious matter of public health and I do 
not want to cause great alarm--but if I follow your 
questioning, we need to get on this quickly.
    We cannot allow the kind of delay and procedure that was 
used in this report to prevail again, so, that we can address 
these other radionuclides which are even more dangerous, which 
could have been deposited from this fallout or from some other 
source. Have I stated this correctly? Please, correct me if I 
am wrong because I do not want to be wrong.
    Dr. Hoffman. I would not want to, at this time, make a 
statement about the overall effect until such studies had been 
completed. I would want to emphasize, however, that the health 
outcomes associated with exposures to these other radionuclides 
are more than likely to lead to the types of cancer that could 
result in a mortality. But whether we are dealing with a few 
thousand cases of excess mortalities or a few tens of thousands 
of cases of excess mortality I will not know until such studies 
have been conducted.
    Senator Durbin. Well, the reason I pointed out Christian 
County, Illinois, is that they have had a lawsuit recently 
concluded where there was an extraordinary incidence of a rare 
cancer, neuroblastoma, in four children and unexplained. And I 
do not suggest it has any connection here, but I can tell you 
that that has caused everyone in this area to be overly 
sensitive as to whether or not there is something unusual in 
that particular area and it just jumped right off the map when 
I opened up this chart and saw that this was one of the 
counties involved here.
    I thank you, Madam Chairman.
    Senator Collins. Thank you.
    Senator Glenn.
    Senator Glenn. Yes. Just one more follow-up one on Senator 
Durbin's comments. I was talking to the staff here while he was 
commenting. I believe you have strontium and cesium, also in 
the radionuclide family that are fallouts from some of this, 
too. Now, should we be concerned about some of those dosages 
because strontium, as I understand it, concentrates in the 
bones. It can cause cancer. Now, maybe it comes from some other 
sources also, I do not know. Cesium is more long-lived, I am 
told, and, so, you may have radiation in you from a collection 
of cesium over time.
    Now, some of these things also are used in the medical 
profession for diagnosis as well as therapy for certain things. 
So, they are used in a controlled fashion that way. My question 
is, do you know whether you could give us some advice on 
whether the dosages are high enough from some of this fallout 
of these other radionuclides that we should be alarmed about 
them and should be doing some similar studies that cover these 
other areas? Or are they so rare that those other 
radionuclides, strontium and cesium, as a source of potential 
cancer is not large enough that we need to worry about it that 
much; there are other things that we should be concentrating 
our efforts on? Do you have any comment on that?
    Dr. Hoffman. It is hard to come up with a simple answer to 
the question that you just posed. In order to give full public 
disclosure as to what the potential health impacts have been 
from testing at the Nevada Test Site, yes, I believe that 
investigations should be undertaken of the full suite of 
radionuclides that have been produced.
    Have significant exposures occurred as a result of the 
deposition of these other radionuclides in fallout? I do not 
know the answer to this until such studies have been 
undertaken.
    How significant is it likely to be? I think it is fairly 
evident that the highest exposures to these other radionuclides 
more likely than not to have come from global fallout because 
these are long-lived radionuclides that accumulate in the upper 
atmosphere and they can deposit over a number of years.
    So, that what we currently measure in our foods and in 
soils of cesium, strontium, and Carbon-14, the bulk of that 
came in from global fallout and not from the Nevada Test Site. 
However, a fraction of that is still a contribution from 
operations in Nevada.
    Senator Glenn. But do we have good information about what 
kinds of cancer or whether cancer is caused by these other 
things like the strontium and the cesium and others, as well as 
Iodine-131?
    Dr. Hoffman. Well, for Iodine-131 the primary organ of 
interest is the thyroid and other than non-neoplastic 
thyroiditis the main issue of concern is the production of 
radiogenic thyroid nodules and carcinomas. For the other 
radionuclides, it is basically looking at the overall 
interaction of radiation in biological matter. And there, I 
believe, the scientific evidence is fairly conclusive and that 
is that any excess exposure to radiation increases one's risk 
over one's lifetime of cancer. That risk may be small but the 
risk is still there.
    Senator Glenn. All right, but the fallout we received such 
as in Maine and the other places where there are hot-spots--it 
would be your opinion, I gather from what you said about the 
long-lasting life of this as opposed to the half-life--that 
these would not necessarily, strontium, cesium, problems, 
whatever they resulted in, would not necessarily be in those 
same hot spots, even though they might have been generated 
originally by the same nuclear event.
    In other words, they would be more long-lived and would be 
more likely to circulate all over the world over a period of 
time and be a hazard for a longer period of time than would 
Iodine-131?
    Dr. Hoffman. That is true. However, you also have to 
question whether or not you could see Strontium-90, Cesium-137 
that originated from Nevada in these locations. And, the answer 
is that yes, indeed, those radionuclides are present at those 
locations. However, their presence may be masked by a larger 
fraction that was deposited with global fallout.
    Senator Glenn. OK. But does strontium concentrate in the 
bones?
    Dr. Hoffman. Yes.
    Senator Glenn. Has anyone ever done studies in these same 
hot spots to determine whether we have higher incidence of bone 
cancer that might be trackable back to strontium?
    Dr. Hoffman. I do not believe so, and I believe that such 
studies would be difficult because of the other potential 
causes of bone cancer. So, that a simple epidemiological study 
that tries to do a geographical analysis of bone cancer and to 
draw correlations more likely than not might produce 
inconclusive results.
    Senator Glenn. OK. I have nothing else.
    Senator Collins. Thank you very much for your testimony.
    Our next panel this morning includes the official who 
managed the radiation study, Dr. Bruce Wachholz, the Chief of 
the Radiation Effects Branch of the National Cancer Institute.
    The Department of Health and Human Services is represented 
by Dr. William Raub, the Deputy Assistant Secretary for Science 
Policy and the Science Advisor to the Secretary of HHS. HHS is 
the Department ultimately responsible for the oversight and 
management of the NCI study.
    I am also going to ask that Dr. Richard Klausner, the 
Director of the National Cancer Institute, join these other two 
witnesses. I would ask that the three of you come forward and 
remain standing so that I can swear you in pursuant to the 
Subcommittee rules.
    Do you swear that the testimony you are about to give will 
be the truth, the whole truth and nothing but the truth, so, 
help you, God?
    Dr. Wachholz. I do.
    Dr. Raub. I do.
    Dr. Klausner. I do.
    Senator Collins. Thank you. Please, be seated.
    I first want to just go over the ground rules for the 
testimony. Any written statements will be submitted in their 
entirety. I am going to ask that oral statements be limited to 
no more than 10 minutes each, using the lights for guidance. I 
want to start with Dr. Wachholz. Do you have a statement that 
you would like to make this morning?

 TESTIMONY OF BRUCE WACHHOLZ, PH.D., CHIEF, RADIATION EFFECTS 
               BRANCH, NATIONAL CANCER INSTITUTE

    Dr. Wachholz. Yes, Ma'am.
    Madam Chairman, Members of the Committee, I am Bruce 
Wachholz, Chief of the Radiation Effects Branch at the National 
Cancer Institute. In that capacity, I have had the opportunity 
to oversee a wide range of radiation research projects funded 
by the NCI and have worked with scientists in other Federal and 
non-Federal agencies and laboratories for 15 years. Also, here 
today from NCI, to my right, are the Director of the Institute, 
Dr. Richard Klausner, and behind me, the U.S. Associate Project 
Director for the Chernobyl Studies, Dr. Ihor Masnyk.
    I would like to ask that the NCI statement be included for 
the record, as I am sure Dr. Klausner would request.
    Senator Collins. It will be.
    Dr. Wachholz. First of all, I would like to express my 
personal appreciation to the Subcommittee for its clarification 
of items in the press that occurred yesterday. It is very much 
appreciated.
    One of the NCI projects, the preparation of the I-131 
Fallout Report, unfortunately took 14 years to complete. Too 
many years. That was for two reasons. First, the recruitment of 
all the experts involved in the study, the data collection, 
management and analysis, computer programs and drafting of the 
report took roughly between 10 and 11 years--much longer than 
either the advisory committee or I originally predicted, but 
not inconsistent with other studies of this type.
    Second, and perhaps more importantly, for almost 2 years, 
from 1994 to 1996, the preparation of the report received 
little attention. I sincerely regret that this has happened and 
I take responsibility for the delay and acknowledge that the 
report could have gotten out faster.
    One of the concerns expressed by the Subcommittee has been 
that those of us involved in the report--and I certainly 
include myself in that group--should have been more sensitive 
to the public's interest in the findings, and we should have 
involved the public more in its development and dissemination. 
In retrospect we should have involved citizens in some way in 
all aspects of the project.
    We did provide continuous presentations to the scientific 
community at meetings of National Cancer Institute Advisory 
Boards, groups at international and national meetings and to 
other Federal agencies who assisted with the methodology. As 
the previous participant, Dr. Hoffman, mentioned, it was 
discussed in the scientific community.
    There was no intent to deceive or to conceal this 
information from anyone, including the public. It, perhaps 
erroneously, never occurred to me that the delay in publishing 
would be interpreted as a so-called coverup or concealment of 
data.
    In fact, one of my primary efforts in the preparation of 
the final document was to ensure that the various categories of 
persons, various diets and so on, be clarified in the report so 
that those persons in the public who might be interested in the 
report would be able to understand the information more clearly 
and have the opportunity to construct their own estimated 
doses. This required extensive rewriting of the document to 
make it as user-friendly as it now appears in print and on the 
Internet.
    The recent review of the report by the National Academy of 
Sciences found it to be a careful, detailed and responsible 
effort with scientific results consistent in most respects with 
the Academy's own analysis. But the reviewers also recommended 
that a focused effort be made with the help of the public to 
develop a program of public information and education about the 
consequences of the Nevada weapons tests.
    I am aware of the criticisms and concerns expressed by many 
about the length of time it took to make our findings available 
to the general public. And I agree and subscribe certainly to 
Dr. Klausner's statement in last October's hearing on this same 
matter, that a clear, faster and more aggressive plan should 
have been put in place to make the results public.
    During that same time period, from 1991 forward, non-
government scientists, NCI staff and I were involved in 
developing long-term studies of health effects, specifically of 
the thyroid that might result from exposure to I-131 from the 
Chernobyl Nuclear Power Plant accident in 1986. We hope that 
these studies will provide a more definitive answer in order to 
assess the risks of thyroid cancer associated with exposure to 
I-131 and, thereby, help to respond to the third component of 
the Congressional mandate.\1\
---------------------------------------------------------------------------
    \1\ See Exhibit 13, which appears in the Appendix on page 893.
---------------------------------------------------------------------------
    However, this is a long-term clinical epidemiology study in 
countries of the former Soviet Union where we face many 
challenges. I surely have learned from the I-131 Report 
experience that this research is of interest not just to 
scientists but also to the medical profession and to the 
public. Therefore, we are all making efforts to inform the 
public as new information becomes available.
    For example, last December we presented the I-131 Report to 
the Centers for Disease Control and Prevention Advisory 
Committee on Energy Related Epidemiologic Research, referred to 
as ACERER, which includes both non-government scientists, such 
as Dr. Hoffman whom you heard from earlier, but also members of 
the public. And we are scheduled to discuss the Chernobyl 
project with the same advisory committee in November of this 
year.
    In addition, last week our contractor at Columbia 
University, who is working with us on the Chernobyl studies, 
and I presented these studies to the National Cancer Advisory 
Board--which also includes members of the public and medical 
professionals. The CDC participated in that presentation, as 
well.
    These Chernobyl studies are the result of interagency 
cooperation and could not have come about without the help of 
the Nuclear Regulatory Commission, the Department of Energy, 
NCI staff, and many non-government scientists with special 
expertise who are willing to devote their time and effort to 
overcoming the challenges involved in helping Belarus and 
Ukraine conduct these studies.
    We have resolved the many and challenging difficulties that 
have come to our attention so far and I am glad to report that 
screening of populations is underway in both Ukraine and 
Belarus. In fact, in the first year of screenings, Belarus is 
very close to meeting its projected target for participant 
accrual.
    When asked last week at the National Cancer Advisory 
Board's open session about the progress of the Chernobyl 
project, Dr. Jeffery Howe, who leads the contract with Columbia 
University to provide scientific and technical support in 
aspects of these projects, said it quite well and I quote, ``. 
. . all epidemiology takes a long time to get going. So, 
despite the apparent length of time I was not surprised and was 
not discouraged. And . . . since I have been actively involved 
in the thyroid studies, I have actually been very impressed 
that things are moving now. . . .''
    We, at NCI, share his optimism and are encouraged by the 
pace of accrual. Shortly, Bi-National Advisory committees will 
meet to discuss how they can best advise all entities involved 
about the progress of the project and how to maintain the 
integrity of the research. Our foreign colleagues and we look 
forward to receiving their guidance, including how best to 
communicate information as it becomes available.
    We know that communicating results of our radiation studies 
to the public requires a careful and thoughtful plan and my 
colleagues and I will be mindful of that in the future. In 
fact, we will work closely with the CDC in order to plan for 
future information for the public in a more thoughtful and 
sensitive manner.
    That concludes my remarks. I would be happy to answer 
questions.
    Senator Collins. Thank you.
    Dr. Klausner, I know you have submitted a written statement 
for the record. Would you like to make a few brief remarks?
    Dr. Klausner. Yes.

 TESTIMONY OF RICHARD D. KLAUSNER, M.D.,\1\ DIRECTOR, NATIONAL 
CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF 
                   HEALTH AND HUMAN SERVICES

    Dr. Klausner. Let me just respond to a few issues that have 
been brought up about how we communicate this very important 
and troubling information to the public. Once I became aware of 
the study, which was in the spring of 1997, we moved very, very 
quickly to make sure that this is presented to professional 
communities, public health communities, and to the public.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Klausner appears in the Appendix 
on page 75.
---------------------------------------------------------------------------
    This report was unprecedented, in that it was 110,000 
pages. It was very complex and we wanted to make it in a form--
and it is very hard to do, and there is lots that we can do 
better--accessible to everyone.
    We put it out on the Internet. Individuals can go in and 
can reconstruct their own predicted doses, based upon where 
they were born, when they were born, and if they can remember, 
what they ate and how much they drank--recognizing that there 
are great uncertainties here.
    We met with and spoke with all State and territorial health 
officials. We had an extensive communication plan with 
professional societies, including the American Thyroid 
Association. There were special sessions at those meetings to 
develop what they would say to their members so that we would 
put out the information that you and Senator Glenn have asked 
for: What should physicians say? What should individuals ask? 
Where they can get information?
    We had many press conferences. The press certainly was very 
helpful in making sure this is a very widely known report. We 
were moving to release it as quickly as we could in, as I said, 
an unprecedented way.
    We have a lot of communication mechanisms at the NCI. The 
most widely used service for getting free information about 
cancer in English and in Spanish is available through a 1-800-
number [1-800-4-CANCER], and we had questions and answers put 
there.
    We did an enormous amount last year--and continue to help 
work with professional societies to get this information out 
and to put it in the context of what to do, what we know, and 
how much about this we do not know. There is still great 
uncertainty about the implications.
    Importantly and largely because of the question of whether 
the Federal Government is credible about these issues--because 
of this terrible history and legacy of secrecy and what the 
government had done--we turned to an independent entity, the 
Institute of Medicine and the National Academy of Sciences, so 
that they could look at the study, if it was well done, if it 
was credible and, specifically, to make advice to all of us--to 
the Nation--about what we should do in terms of public health 
implications, medical monitoring implications, and advice about 
what we should do for education and communication.
    I know that we can do everything better but I want to 
assure you that ever since this report came to my attention I 
think we have moved in an unprecedented way to be open, to be 
communicative, to provide the type of information that you have 
been asking for today, and the type of information that Dr. 
Hoffman has talked about.
    One final thing. The CDC has done a spectacular job with 
radiation-related studies, including the Community and 
Oversight Boards. What we have done since a year ago is sign a 
memorandum of understanding between myself and the head of this 
area of the CDC. All NCI radiation studies are now presented to 
the CDC's Public Oversight Board to correct what we saw were 
deficiencies in the process and which I know you are concerned 
about.
    So, I just want to assure you that we have been acting.
    Senator Collins. Thank you.
    Dr. Raub.

   TESTIMONY OF WILLIAM F. RAUB, PH.D.,\1\ DEPUTY ASSISTANT 
 SECRETARY FOR SCIENCE POLICY, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Dr. Raub. Thank you. Madam Chairman, Senator Glenn, I am 
pleased to present the perspective of the Department of Health 
and Human Services on the conduct of two studies designed to 
examine the effects of exposure to Iodine-131 following nuclear 
testing or accidents.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Raub appears in the Appendix on 
page 87.
---------------------------------------------------------------------------
    My colleagues and I appreciate the time and attention the 
Subcommittee staff has devoted to its review of these studies. 
The Department recognizes as understandable and legitimate the 
frequently expressed concern that the exposed populations in 
both cases may be at higher risk of diseases of the thyroid, 
particularly cancer.
    We share your desire that our research be conducted both 
rigorously and efficiently and that outcomes be used to promote 
national policies that are protective of the public health. The 
National Cancer Institute is the appropriate organization to 
direct research toward resolving these concerns. It has the 
requisite expertise and experience. In particular, its staff 
includes leading international authorities on radiation 
epidemiology and radiation dosimetry.
    The Subcommittee has raised important questions about our 
response to Public Law 97-414, which directed the Department to 
conduct the study related to the Iodine-131 fallout from the 
Nevada Test Site. NCI clearly took too long to complete the 
study. We have learned important lessons about use of resources 
and the setting of priorities as a result of our experience 
with the Iodine-131 study. NCI already has instituted important 
management reforms to ensure that repetitions of this do not 
happen.
    The Department, for its part on a broader basis, will 
review its procedures for monitoring such major studies and, 
where necessary, will institute reforms to ensure that we do 
not repeat the experience of the Iodine-131 study.
    As you know, the Institute of Medicine reviewed the NCI 
study and recently issued its own report. IOM assessed the 
soundness of National Cancer Institute's analysis and 
assumptions and its estimates of risk of thyroid disease from 
Iodine-131 fallout. IOM also analyzed the issues associated 
with population-based screening for thyroid cancer and the 
challenges associated with providing clear and useful 
information about the risks of both radiation and screening to 
those who have been exposed. We are currently studying IOM's 
report so that the Department can be responsive to its 
findings.
    I call your attention to the fact that IOM did not 
recommend population-based screening for people exposed to 
radiation fallout. Testimony earlier today from the Agency for 
Toxic Substances and Disease Registry, however, indicates that 
it recommends medical monitoring for people exposed to 
radiation from the Hanford Nuclear Reactor. In his testimony, 
Dr. Johnson, of ATSDR, compared his agency's recommendation 
with the IOM findings. He correctly noted that ATSDR, and NCI 
studies differed considerably with regard to circumstances, 
methodology, outcomes, and requirements. On their face, the 
ATSDR and IOM conclusions do not appear to be in conflict.
    However, the Department will review policies and practices 
at the Centers for Disease Control and Prevention, ATSDR and 
NCI to identify significant differences, if any, in their 
respective approaches to dose reconstruction and determinations 
regarding the need for and feasibility of population-based 
screening or medical monitoring.
    If we find any differences that we believe jeopardize the 
Department's ability to be protective of the public health, we 
will initiate corrective action.
    The ongoing NCI study of the Chernobyl disaster is a unique 
opportunity to examine the effects of radiation on people. We 
have confidence that the Institute is on course toward 
identifying proper cohorts, estimating exposure, and assessing 
risks of disease.
    The Department is aware of the difficulties of conducting 
such research in countries that had been part of the former 
Soviet Union. The science of epidemiology is not as uniformly 
well developed there as here. In many cases resources and 
experience lag far behind those available in the United States, 
and managing a major international study in an area of the 
world that is experiencing significant political and economic 
instability is a difficult undertaking.
    As a consequence, I do not think we should judge the 
progress of the Chernobyl study using the same standards that 
we would apply to a study conducted in the United States. 
Nevertheless, the Subcommittee staff, in its discussions with 
us preceding this hearing, raised several important management 
issues related to the Chernobyl research.
    Because this research is so important and, we hope, the 
only opportunity we ever have to study such exposure in human 
beings, the Department wants to be certain that the Chernobyl 
work is done as effectively and as efficiently as possible. We 
recognize the concerns of the Subcommittee, and we take them 
seriously.
    I will work with NCI staff to arrange for an independent 
review of the Chernobyl project to identify any problems 
associated with the way the work is planned, organized, 
conducted, and overseen.
    Our plan to seek an independent review does not mean we 
lack confidence in the National Cancer Institute. To the 
contrary, we believe NCI is the right organization to conduct 
this research, and we are intent upon doing everything 
reasonable toward ensuring that the project remains 
appropriately oriented and proceeds as expeditiously as 
circumstances allow. We will await the outcome of the 
independent review with an open mind.
    Thank you for the opportunity to testify today.
    Senator Collins. Thank you, Dr. Raub.
    Dr. Wachholz, I want to get in my mind a clear 
understanding of the timetable and also the reasons for delay. 
Dr. Hoffman testified this morning that the NCI report was 
essentially completed in 1992, is that correct?
    Dr. Wachholz. The data base and most of the analysis were 
complete by that time, yes, Ma'am. The report, itself, in its 
entirety was not complete until 1994.
    Senator Collins. All right. I will accept the 1994 date 
then for the purposes of this discussion. Considering that the 
study's findings were that people in unexpected areas of the 
country, including States like Maine, were exposed to high 
levels of radiation, why did you wait so long before releasing 
this information to the public?
    That is the question that I am having a great deal of 
difficulty with.
    Dr. Wachholz. Understandably so, Madam Chair.
    I have to take you back to that time. Quite candidly, there 
had been literally no inquiry with regard to this particular 
study during the preceding 10 or 11 years. In addition, our 
Advisory Committee had been disbanded in 1993. Certainly 
wrongly in retrospect, obviously, the sense was that nobody was 
really terribly interested in this. That, in and of itself, is 
not sufficient.
    I think you also have to keep in mind that concurrent with 
those times we were becoming increasingly involved in the 
Chernobyl studies which were taking a great deal of time, 
particularly from 1993, 1994, 1995, and onward. We could not do 
both with equal dedication.
    Given the situation at NCI at that time, when there were 
uncertainties and changes in management in 1993, 1994, and 
1995, I had to make a decision as to whether or not we would 
make a major effort to establish ourselves in the countries of 
the former Soviet Union in order to work with the governments 
there in order to address the third component of the law that 
has been mentioned earlier, namely the risk co-efficient for 
thyroid cancer--versus getting the report out and letting the 
Chernobyl study pass essentially--and we could not do both with 
equal dedication at that time.
    Senator Collins. The public cannot be interested in what 
the public does not know. The interest in this report was 
enormous once it finally was released. Was there any concern on 
your part that, did you delay for any reason, related to your 
concern about what public reaction to the report might be?
    Dr. Wachholz. No, Ma'am.
    Senator Collins. Was the report only released when Congress 
started pressuring the agency, saying, where is this report? We 
were notified back in 1992 by the NCI that we were going to 
receive it in 1992.
    Dr. Wachholz. When Dr. Klausner and his senior staff became 
established in mid-to-late 1995, the situation was discussed 
with my supervisor at that time, and steps were taken to 
augment the staff. So, starting in 1996, I could devote time to 
getting this report out.
    In early 1997, I think, I wrote a letter to CDC responding 
to their request as to when the report would be out. I think I 
indicated at that time that we were hoping to have it out by 
October 1, 1997, which predated any of the press involvement. 
We recognized ourselves that we just had to get this report out 
and once we had a management structure in place to be of 
assistance in this, we made progress on it.
    Senator Collins. I know that Senator Glenn is going to want 
to follow-up on those issues. I am just going to ask one 
question of Dr. Raub before turning over the questioning to 
Senator Glenn.
    Does not HHS bear some responsibility here? It was HHS' 
decision to delegate the report to the National Cancer 
Institute. How did HHS let such an important study fall through 
the cracks? Do you not have a system for tracking 
congressionally mandated studies?
    Dr. Raub. Madam Chairman, you are right. The Department 
does bear responsibility with NCI here. The system for tracking 
congressionally mandated projects clearly failed in this 
instance.
    Senator Collins. Senator Glenn.
    Senator Glenn. Well, is there a system?
    Dr. Raub. Yes, sir. It is not clearly as uniform as it 
ought to be but there are attempts, especially with 
appropriations actions within the Department, to try to ensure 
that there is systematic follow-up. We clearly have not done as 
good a job with respect to mandates occurring in legislation 
outside of appropriations.
    Senator Glenn. I would think this would be fairly simple, 
not only in your office, but out in NCI also, Dr. Klausner. You 
came in 1995, so, a lot of this pre-dates your arrival there. 
But any big endeavor like the Department's or agencies that you 
operate will often have a big board on the wall or a pert chart 
where you list the different things and when they are due. The 
list includes all these things, including due dates and whether 
it either made it or it does not.
    How do you keep faith with the people who asked for this 
report? There apparently is no such system operable. Or, at 
least for this report, if there is, it really fell through the 
cracks because we are talking about 14 years.
    And we are talking about even when we received annual 
reports from NIH and the annual reports of the National Cancer 
Institute from 1992 to 1995 regarding this report, the report 
stated that the activities, ``Have been completed during the 
current reporting period.''
    Each year they are telling us over and over again the 
report has been completed and then additionally the Advisory 
Committee for the study was even disbanded in 1993 as you have 
mentioned, Dr. Wachholz. So, here we have a study all completed 
and nobody is checking on it to see that it just gets 
submitted.
    Now, somewhere, obviously, things fell through the cracks 
and Dr. Wachholz is taking complete responsibility for this. I 
gather that you had competing things demanding your time. Are 
you short-handed? Do we need more support in these areas? 
Obviously the squeaky wheel gets the grease at NIH or NCI or 
any place else and if we are not griping about not getting a 
report, maybe it gets shifted back some place and that is not 
the way the system is supposed to work.
    We should not have to heckle people into getting a report 
once the thing is done. It should not sit out there for years. 
And you have already admitted that this report fell through the 
cracks, but this makes me wonder how many more reports have 
been requested for very good reasons, people doing studies and 
so on and concerns about health, and how many more are sitting 
some place because there is not a system in place to make sure 
that we get them moving off dead center and in here somewhere 
close to their deadline.
    Now, do we have a system or do we not? I will start with 
you, you are HHS, and then I will go to Dr. Klausner and see 
what kind of a system you actually have right now.
    Dr. Raub. The system that exists now, Senator Glenn, is 
oriented heavily toward those requirements that are associated 
with appropriations bills, as I indicated. I am not aware that 
we are remiss in failing to track or report other mandated 
studies, but I could not at this moment give you assurance that 
we are not.
    Senator Glenn. What you are saying is, unless it is an 
appropriations bill then it is going to get sent back to second 
status, is that correct?
    Dr. Raub. No, sir. I did not mean to imply that, but rather 
that I believe the system is better developed with respect to 
appropriations language.
    Senator Glenn. Well, we are not an appropriating committee 
over here and, yet, we ask for studies. This Committee, as a 
matter of fact, I think we have a record on this Committee. We 
did not set out to do it that way. But we have the broadest 
areas of responsibility on this Committee of any committee in 
the Congress. We overlap almost every other committee. Most 
people do not realize that. And we normally have the most 
General Accounting Office studies, for instance, going on 
behalf of this Committee.
    And, so, we probably have a lot of requests out there and I 
do not want to think because it does not involve an 
appropriation matter that we are going to get second-class 
treatment, unless we are notified. If somebody says we have got 
an appropriation matter and they are demanding action right 
now, we got to get that thing out there for them, right now, I 
understand that. The appropriations are the big stick around 
here and that is understandable. But then if it comes at a time 
when we have said we would like to have it by a certain time 
and you have agreed it is going to be by a certain time, then 
we should be notified of that. And we are very understanding of 
the appropriations problems.
    But we cannot have anything like this dropping through the 
cracks where it sits for 14 years although it was done in 1992. 
And in 1993 you disband the committee and we are still sitting. 
And it does not see the light of day until Senator Daschle's 
staff, I believe, made an inquiry in 1997. That is how it 
finally came to light that it was not up here.
    Maybe some of the rest of us should have our own little 
check-off lists up here, too. But I would hope that we do not 
have to go through that. We should depend on you to do that for 
us.
    Dr. Raub. You are absolutely right, Senator. We should 
ensure that the system is uniformly effective.
    Senator Glenn. Good. What do you have, do you have a big 
chart in your office out there, Dr. Klausner? And if not, why 
not?
    Dr. Klausner. No, I do not. But what we----
    Senator Glenn. Well, you are going to develop one real 
quick, are you not?
    Dr. Klausner. No. Actually we have already done it and it 
is on the computer screen. But there was no uniform tracking 
system and this issue brought that to light. So, what we have 
developed over the last year is what we think is a very good 
computer-based tracking system for all Congressional requests, 
all reports, wherever they come from. It will be automatically 
updated so it will automatically generate the progress reports.
    We did not have that system before. It will be fully 
operational this Fall. We have been prototyping it and 
developing it over this past year. And I think that is exactly 
how this happened.
    When I came in to head the agency there were thousands of 
projects and I simply did not learn about this project until it 
was brought to my attention. And you are right, it was from a 
letter from Senator Daschle that I realized that this was 
something that had been requested by the Congress.
    Senator Glenn. OK. Everybody is saying we did wrong on this 
and we are going to correct it and all that. Let us move on to 
Chernobyl. I am concerned about that, because as I understand 
it, that is supposed to provide us and other countries around 
the world with a great deal of information about the 
relationship between radioactive iodine and thyroid cancer.
    Although it is not our country, they gave us permission and 
we are quite happy to come in and do this study working with 
their people. And normally in doing these things we have a 
protocol set up on how it is going to go. And that is what we 
call these arrangements made, governed by scientific plans, it 
is a scientific plan called a protocol. And these protocols 
were signed in 1994 by a number of countries. And there was 
supposed to be a committee to oversee that, an advisory 
committee, as I understand it. And they would manage and 
oversee our involvement in that study.
    Now, that was to be several different countries 
represented. What is the status of that? As I understand it, 
when did those people get appointed? This whole thing started 
way back. Dr. Wachholz, you were asked in 1994 to appoint five 
individuals to that committee. When were those people nominated 
or selected?
    Dr. Wachholz. We began identifying people and inviting 
their participation in 1996. And the delay there, if you read 
the protocol--with your permission I can read the relevant 
section or sentence.
    Senator Glenn. Certainly.
    Dr. Wachholz. ``With the approval of the project by 
authorities of both countries and assurance of funding by both 
sides, the oversight group or advisory committee would be 
confirmed.''
    The assurance of funding really did not occur until 1996, 
both in their governments as well as financial support from the 
United States to the scientists working on these projects in 
Belarus and Ukraine.
    Senator Glenn. You did not name the board then for that 
length of time because the funding was not there to establish 
the board or what?
    Dr. Wachholz. That is part of it. The other part is that 
the studies actually began in terms of involvement of subjects 
of the study in 1997 in a serious way.
    Senator Glenn. Well, we had the original plan that called 
for conducting this study in Belarus and it is about 4 years 
old now. Can you tell us how many people were supposed to have 
been screened by the end of 1997, by the end of last year and 
what our status is in that?
    Dr. Wachholz. Senator, I will be glad to answer your 
question but could I put it in context first?
    Senator Glenn. Sure.
    Dr. Wachholtz. We are dealing with systems over there that 
do not have a history of research in the context that we are 
talking about here. Between, for example, 1994 and 1996, there 
were three changes in ministers of health in Belarus, there 
were six changes of ministers of health in Ukraine. In Belarus, 
also, we faced changes in the directors of the institute that 
we are working with, as well as many of the senior staff. This 
led to a great deal of difficulty.
    Also, we learned, for example, that the signature on the 
agreement in 1994--by the minister of health of Belarus--had 
not been validated by the Council of Ministers of the President 
of that country. That did not occur until 1996.
    So, I am just giving you the very tip of the iceberg of the 
type of problems we have had to overcome there. These are their 
people, their scientists. We are working with them, but we are 
not conducting the study. And we have to adjust our 
expectations to the realities that we find over there that are 
different every time we go over, literally.
    Senator Glenn. OK. Now, you have been operating pretty much 
without this advisory committee then that was not possible to 
set up, you say, until some time in 1996. Then you have been 
operating just sort of out of National Cancer Institute, 
yourself?
    Dr. Wachholz. No, sir.
    Senator Glenn. Or how?
    Dr. Wachholz. In the early 1990's, when NCI first began to 
get involved in this at the request of the Department of 
Energy, we established a working group under and associated 
with the Fallout Advisory Committee that was subsequently 
disbanded in 1993.
    There were 10 people on this working group. Roughly half 
were Federal scientists and half non-Federal scientists. Most 
of those people are still working with us today. That group was 
called, for shorthand, a working group, which dealt with both 
countries. That existed until September 1996.
    From 1996 on, the individuals were still working with us, 
not as a group, but as consultants, essentially. So, all the 
way along this entire development we have had people outside 
the government as well as inside the government working with 
us, giving us guidance on all aspects of things--including 
people in other agencies, and the State Department, and the 
embassies--on how to face the problems we have come up against.
    In 1996, Dr. Klausner met with senior officials of the 
Department of Energy and decided that because these studies 
were imminent in terms of their implementation, we would need 
to augment the resources available within this country. The 
decision was made at that time to go out for a contract for 
scientific and technical involvement on a more broad-scale 
basis because many of the people that had been working with us, 
if I may say so, are very senior citizens. I hesitate to say 
that to you, sir, but----
    Senator Glenn. That is quite all right.
    In some of my endeavors, age has become an advantage not a 
disadvantage. [Laughter.]
    Dr. Wachholz. The contract was let at the end of September 
1997. Since then we have had access to additional outside 
expertise through the contract, as well as from the people that 
have been working with us all the way along the line.
    So, through this entire period it is not just NCI or our 
organization that has directed or controlled this study. It has 
involved a lot more people than that.
    Senator Glenn. Well, I understand that. My big concern is 
that we are about 12 years after Chernobyl and every year, 
every month that goes by it gets tougher and tougher and 
tougher to contact the people and do the studies and find out 
who is where and all the rest. So, we have got everybody 
dispersed and as you say, there have been many changes of 
administration. There may be more one of these days, we do not 
know.
    But anyway we are going through a time period where time is 
of the essence and we are letting it get away from us. Now, 
maybe it has not been under your control, but we had planned by 
this time, by some of the figures I was given, the original 
plan called for us by the end of 1997 to have screened some 
15,000 people. What we were able to do, we have had 3,500 
contacts and we have had 2,900 who have been screened.
    Now, maybe that is a sample large enough to tell us a lot. 
I do not know. Maybe we can get as much out of 2,900 as we 
would if we had done the whole 15,000. That was in Belarus.
    In the Ukraine, the original plan was to have screened 
30,000 people and today we have had 800 contacts and 530 
screened. And maybe there have been all the management and the 
funding problems but I am concerned that this is beginning to 
get away from us as far as time goes.
    Is there a management plan, a management structure in place 
that is really managing this and are the pieces beginning to 
fit in there and we are ready to go? Because pretty soon you 
begin to raise the question of whether money spent on this is 
going to be worthwhile.
    After we get up to 15 years or so, if we have not found out 
something about what happened at Chernobyl or do not have 
enough cooperation from them or funding or whatever, why I 
think we need to begin to think about the viability of it and 
whether it is worth the candle here.
    So, I would appreciate your comments on that. Do we now 
have a management structure in place? And then, Dr. Klausner, I 
would like to have you comment on it also. Something has to be 
managed here to the point where we either get results one of 
these days, after 12 years, or let us just say it was a bad 
deal and we will forget it.
    Dr. Wachholz. Senator, I know it has been 12 years since 
Chernobyl. The involvement of our activities obviously has been 
less than that. But in terms of the delays, and you mentioned 
Ukraine specifically, the Ukrainian Government imposed the 
regulatory constraints on us at the end of 1996 that precluded 
us from doing anything until earlier this year.
    I think now that we have resolved those they are beginning 
to get started. As you indicated, with 529 participants. That 
is just their effort since, I think, May or June. We anticipate 
that that is going to pick up rather dramatically over the next 
several months or year.
    In Belarus, once the screening was to be started, I think 
that the first year of screening the protocol originally had 
projected 3,000. We are pretty close to that. Whether we can 
keep that up or not will depend on circumstances over there. 
Certainly we have to adjust as we go over there every time.
    In terms of the long-range plan, the protocol is the 
ultimate long-range plan. But in terms of developing the 
resources and the financial support to do this, we are working 
on that, so that we do not run into the same problem that we 
ran into on the fallout study.
    Senator Glenn. Dr. Klausner.
    Dr. Klausner. Senator, I think that all of us who look at 
this study recognize how important it could be and how 
difficult it is going to be. We should be under no illusions. 
For many of our clinical studies where there is a clinical 
epidemiologic study, there are tremendous difficulties and over 
there the difficulties are amplified.
    I wish I can guarantee the rate at which we would get a 
result. We certainly want to make sure these studies are 
completed. One of the reasons that we had this presented to our 
National Cancer Advisory Board is to ask those questions.
    The delay from beginning was getting an infrastructure in 
place. I think the original protocol was very unrealistic and 
it was written as if it was doing a study in the United States 
and as if there was an infrastructure to do this sort of study. 
It has taken the last several years to build the 
infrastructure, to build relations, to build trust, to build 
expertise, to build data bases, to translate things.
    I think the most important thing--from my oversight of it, 
to see how it is going, and for the National Cancer Advisory 
Board--is that once we got to that point of getting an 
infrastructure in place so the study could happen: Is the rate 
of identification of the cohorts, the rate of response of the 
individuals, and the rate of screening, going up? Is it 
increasing? Does it look like we are going to achieve the 
milestones? So far it is looking optimistic.
    I do not want to overstate that. This is going to be a 
difficult study to complete. But it is progressing and I think 
the entire Advisory Board really felt that. They mostly felt 
how amazingly difficult the challenge of the study is going to 
be but that once we have gotten the infrastructure in place and 
they actually began screening, the rate of screening is not 
very far from the projection in terms of the quarterly rate.
    Senator Glenn. Well, correct me if I am wrong, but my 
understanding is that some of the other nations have been in 
there looking at these things, too, and doing screening and I 
do not know what their problems are. But I understand, I have 
been told anyway that the Japanese have already screened 
160,000 kids between 1991 and 1996.
    Why can they do these things and we cannot? What is the 
problem?
    Dr. Klausner. The nature of the studies is really quite 
different. There have been thousands of publications already 
that have come out from studies related to the Chernobyl 
accident. But to attempt to do the type of study that has never 
been done--a careful dosimetry, dose reconstruction--so that we 
ultimately can actually have not estimates but a real 
assessment of what the risk is in humans, as a function of age 
and gender, from a dose of Iodine-131 received? What is that 
risk of getting cancer over years? That has not been done.
    I think the complexity of this study, the importance of 
this study, is just that. But with that importance is an 
increased complexity that is different from a lot of the other 
studies, for any of the other studies that have been done.
    Senator Glenn. Well, they went in there, their study had a 
different purpose than ours, is that correct?
    Dr. Klausner. Yes, I believe that is right.
    Senator Glenn. Correct, Dr. Wachholz?
    Dr. Wachholz. Yes, sir.
    Senator Glenn. Yes. The 1994 protocol called for an annual 
report to the Advisory Committee. That report is supposed to 
assess organization of the study, progress, staffing, 
equipment, status of locating subjects, fiscal report. Has such 
a report ever been prepared?
    Dr. Wachholz. No, sir, there is no report of the Advisory 
Committee because there is no Advisory Committee at this point. 
There are progress reports from the countries on a quarterly 
basis, but they have not been consolidated into an annual 
report.
    If I may, sir, you are focusing on the Advisory Committee. 
We, at this point, do have an Advisory Committee, and we have 
had one on several occasions in the past. But for one reason or 
another people have had to withdraw because of either actual or 
perceived conflict of interest.
    As of this date we have identified individuals for the U.S. 
component. We have their counterparts from Belarus and Ukraine 
and we certainly expect to schedule a meeting as soon as we can 
get everyone's calendar to match.
    Senator Glenn. I am concerned about the management 
structure and Dr. Klausner, maybe you ought to comment more on 
this. I would ask, first, do we at this time have a project 
plan on this? Do we have a 3- and a 5-year budget plan for 
equipment and supplies and people and----
    Dr. Klausner. Yes.
    Senator Glenn. Where are we going with this thing? Is it 
now, in other words, organized or do we need to ask you to have 
a report from you within 30 days where you detail what the plan 
is and the management structure or----
    Dr. Klausner. I would be delighted to provide one.
    Senator Glenn [continuing]. Or can you assure us today that 
it is all set up and ready to go?
    Dr. Klausner. I can assure you today that it is going. It 
is happening. I think, again, part of what is difficult about 
this is that given the nature of the study we have to be nimble 
and flexible. We keep running into problems. We discover them. 
We run into the need for new expertise. And we need to be able 
to respond to that.
    We can get into sort of ``the best laid plans of mice and 
men.'' We can have a written out protocol. We are trying to 
follow it. I can and will be happy to provide for you a 
description of how we are getting the studies done. There is a 
management structure. There is a reporting structure. There is 
a project director. I want to emphasize the project director in 
Belarus is a Byelorussian scientist and the project director 
for the Ukrainian study is Ukrainian. We are advisory to them 
and we work with them.
    The major way that we determine the budget is that we have 
a 3-year contract, with Columbia University; so we have a 3-
year budget, with a 2-year period of award increase. That is 
the way we budget these sorts of projects. That is the way we 
always budget them. We have interactions with the NRC (Nuclear 
Regulatory Commission) to provide for equipment and, in 
addition, we have the updated estimates that I get with each 
annual budget from the division that Dr. Wachholz is in, what 
we are going to need to support new meetings, travel and that 
is approved every year.
    We are committed to this. We only have, as you know, 1-year 
funding. But we plan for multi-year projects. That is what we 
do for all of our projects. I am happy to provide that for you 
in writing.
    Senator Glenn. Well, staff was informed that there are no 
3- or 5-year budget plans for equipment and supplies, is that 
correct?
    Dr. Klausner. I have been given a projection of the 
estimate of the next 3 years' budget. These are changing year-
by-year as we see, for example, whether a van breaks down and 
then we need to buy a van. I think that is the nature of this. 
We are committed to try to find the dollars. We have a base 
budget which we think are the predicted costs that we are going 
to need to fulfill the contract, to fulfill the staff 
obligations, and a commitment for equipment.
    What happens as you go along all of these long-term 
projects is that there are, in fact, unexpected costs.
    Senator Glenn. I understand that but do you have the 
overall plan, a 3- and 5-year plan for equipment and supplies? 
Is that in place now, so, we know what is going to be expected?
    Dr. Klausner. I can give you the 3-year--which is all that 
has been presented to me--estimate of what dollars are going to 
be needed in each fiscal year for this project. I have that, as 
we do for all of our clinical trials. But I will emphasize that 
they change, essentially, yearly.
    Senator Glenn. I understand the change, but what I am 
concerned with is there is a management structure that even if 
it changes year-in/year-out, we have a structure here that is 
dealing with this on a year-in and year-out basis.
    Dr. Klausner. Yes, we do.
    Senator Glenn. And if you have it for the 3-year plan, 
could we have that submitted to the Committee for our records?
    Dr. Klausner. Sure.\1\
---------------------------------------------------------------------------
    \1\ See Exhibit 6, which appears in the Appendix on page 767.
---------------------------------------------------------------------------
    Senator Glenn. Then we will know what your planning is in 
that direction.
    Dr. Klausner. Sure.
    Senator Glenn. And do you have milestones and hurdles you 
expect to hit, Dr. Wachholz? Do you have things in here that 
you hope to accomplish by a certain time and have some idea now 
that after all this time we are going to get the information we 
need?
    Dr. Klausner. Well, as you pointed out, our original 
projections for time factors and when things would be 
accomplished was rather unrealistic when we came face-to-face 
with reality over there.
    We have learned from that and, so, our milestone 
projections at this point are basically on a quarterly basis. 
When we go over there, we work with people, we identify, review 
and so on, what the previous milestones have accomplished, 
where they stand and what can be done in the next quarter.
    Senator Glenn. Dr. Raub, there seems to be some discrepancy 
or a great discrepancy in the way that different agencies 
approach their radiation research, especially with respect to 
openness and public participation. Obviously we get greater 
credibility and public acceptance the more open these studies 
are.
    What are you doing in the Department, what kind of effort 
are you putting forward to establish a departmentwide policies 
and guidelines so that there will be a consistent approach to 
these studies?
    Dr. Raub. Senator, heretofore, we have not. We viewed it as 
a matter delegated to the respective agencies. As Dr. Johnson 
indicated before, much of the work at the Agency for Toxic 
Substances and Disease Registry and the Centers for Disease 
Control tends to be, to use his phrase, site-specific and, 
therefore readily focuses on the potentially affected 
populations. And I believe it has worked well in terms of 
broader public involvement in those processes.
    In hindsight, as indicated also by earlier testimony, the 
larger NCI study did not do that. In my testimony I indicated 
that collectively, as the Department, we would look at our 
practices and procedures related to dose reconstruction and 
other considerations to ensure that we do not have significant 
unexplainable differences in our approaches and try to promote, 
as it is appropriate, a greater degree of uniformity across the 
Department.
    Senator Glenn. OK. I want to commend you and HHS for 
agreeing, as you said earlier, agreeing to undertake an audit 
of the Chernobyl, and I look forward to having information from 
you at that time.
    I would say that if you get information that you think is 
appropriate for the Subcommittee, we would appreciate it being 
forwarded to the Subcommittee by letter, rather than waiting 
for a hearing or something.
    Dr. Raub. Yes, sir.
    Senator Glenn. Because we will be out of session, this 
being an election year, we will not be in until January. I 
would hope we would be getting some information on these very 
shortly. These are things we have waited for, for a long time.
    Now, Dr. Klausner, you said you have thousands of projects 
out at NCI, which you do. Have you screened those to see if you 
are overdue by X number of years, months, or whatever, on 
reports that we have been expecting here or somebody has been 
expecting for a long time?
    Dr. Klausner. I have certainly asked for that. We have been 
reviewing everything and we have not found anything that at all 
looked like this 12-year project.
    Senator Glenn. Thank you, Madam Chair.
    Senator Collins. Thank you, gentlemen.
    I think that we have learned from this experience. When 
dealing with an issue that has serious public health 
consequences, it really is imperative that deadlines be met or 
that the agencies involved give an explanation to Congress as 
to why they are not being met.
    To fail to do so only creates a climate of distrust, 
apprehension and fear that is in no one's interests and that 
can lead to wrong conclusions of conflict of interest or 
concealment or cover-up being reached.
    I do not believe that is what happened in this case. I 
think it is an example of poor management and of failure to 
understand the public interest in the report in the sensitivity 
of the materials. It is, nevertheless, important that these 
kinds of mistakes not occur in the future and I think that 
Senator Glenn's emphasis on simply having a system where 
reports are tracked is a very good one.
    I want to yield to Senator Glenn for any concluding 
comments that he might have or any concluding questions.
    Senator Glenn. Thank you, Madam Chairman.
    I would just ask that the record be kept open for 10 days 
so that we might, if other Members do have questions in this 
regard or if we have some follow-up questions we think about 
that we should have asked today and did not, we hope the 
witnesses would respond promptly so that we can get that as 
part of the record.
    So, I would ask unanimous consent that that be the case.
    Senator Collins. The record will remain open for 10 days 
for the inclusion of additional materials and possible 
additional questions and answers for the record as well as any 
public comments that may be submitted to the Subcommittee.
    I want to thank Senator Glenn for bringing this issue 
before the Subcommittee. It was a very interesting issue. I 
know that I learned a lot and I believe that we served our 
constituents well by pursuing this issue.
    Senator Glenn. Thank you, Madam Chairman.
    I appreciate very much your willingness to hold a hearing 
on this. I think it is important and I think we have aired this 
pretty well today. I can see where we maybe have had some 
deficiencies in the past. I hope, because of this hearing, we 
will see those things corrected.
    Senator Collins. Thank you.
    The hearing is now adjourned.
    [Whereupon, at 12:06 p.m., the Subcommittee was adjourned.]



                            A P P E N D I X

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