[Senate Hearing 105-686]
[From the U.S. Government Publishing 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
----------
[GRAPHIC] [TIFF OMITTED] 51644.001
[GRAPHIC] [TIFF OMITTED] 51644.002
[GRAPHIC] [TIFF OMITTED] 51644.003
[GRAPHIC] [TIFF OMITTED] 51644.004
[GRAPHIC] [TIFF OMITTED] 51644.005
[GRAPHIC] [TIFF OMITTED] 51644.006
[GRAPHIC] [TIFF OMITTED] 51644.007
[GRAPHIC] [TIFF OMITTED] 51644.008
[GRAPHIC] [TIFF OMITTED] 51644.009
[GRAPHIC] [TIFF OMITTED] 51644.010
[GRAPHIC] [TIFF OMITTED] 51644.011
[GRAPHIC] [TIFF OMITTED] 51644.012
[GRAPHIC] [TIFF OMITTED] 51644.013
[GRAPHIC] [TIFF OMITTED] 51644.014
[GRAPHIC] [TIFF OMITTED] 51644.015
[GRAPHIC] [TIFF OMITTED] 51644.016
[GRAPHIC] [TIFF OMITTED] 51644.018
[GRAPHIC] [TIFF OMITTED] 51644.017
[GRAPHIC] [TIFF OMITTED] 51644.019
[GRAPHIC] [TIFF OMITTED] 51644.020
[GRAPHIC] [TIFF OMITTED] 51644.021
[GRAPHIC] [TIFF OMITTED] 51644.022
[GRAPHIC] [TIFF OMITTED] 51644.023
[GRAPHIC] [TIFF OMITTED] 51644.024
[GRAPHIC] [TIFF OMITTED] 51644.025
[GRAPHIC] [TIFF OMITTED] 51644.026
[GRAPHIC] [TIFF OMITTED] 51644.027
[GRAPHIC] [TIFF OMITTED] 51644.028
[GRAPHIC] [TIFF OMITTED] 51644.029
[GRAPHIC] [TIFF OMITTED] 51644.030
[GRAPHIC] [TIFF OMITTED] 51644.031
[GRAPHIC] [TIFF OMITTED] 51644.032
[GRAPHIC] [TIFF OMITTED] 51644.033
[GRAPHIC] [TIFF OMITTED] 51644.034
[GRAPHIC] [TIFF OMITTED] 51644.035
[GRAPHIC] [TIFF OMITTED] 51644.036
[GRAPHIC] [TIFF OMITTED] 51644.037
[GRAPHIC] [TIFF OMITTED] 51644.038
[GRAPHIC] [TIFF OMITTED] 51644.039
[GRAPHIC] [TIFF OMITTED] 51644.040
[GRAPHIC] [TIFF OMITTED] 51644.041
[GRAPHIC] [TIFF OMITTED] 51644.042
[GRAPHIC] [TIFF OMITTED] 51644.043
[GRAPHIC] [TIFF OMITTED] 51644.044
[GRAPHIC] [TIFF OMITTED] 51644.045
[GRAPHIC] [TIFF OMITTED] 51644.046
[GRAPHIC] [TIFF OMITTED] 51644.047
[GRAPHIC] [TIFF OMITTED] 51644.048
[GRAPHIC] [TIFF OMITTED] 51644.049
[GRAPHIC] [TIFF OMITTED] 51644.050
[GRAPHIC] [TIFF OMITTED] 51644.051
[GRAPHIC] [TIFF OMITTED] 51644.052
[GRAPHIC] [TIFF OMITTED] 51644.053
[GRAPHIC] [TIFF OMITTED] 51644.054
[GRAPHIC] [TIFF OMITTED] 51644.055
[GRAPHIC] [TIFF OMITTED] 51644.056
[GRAPHIC] [TIFF OMITTED] 51644.057
[GRAPHIC] [TIFF OMITTED] 51644.058
[GRAPHIC] [TIFF OMITTED] 51644.059
[GRAPHIC] [TIFF OMITTED] 51644.060
[GRAPHIC] [TIFF OMITTED] 51644.061
[GRAPHIC] [TIFF OMITTED] 51644.062
[GRAPHIC] [TIFF OMITTED] 51644.063
[GRAPHIC] [TIFF OMITTED] 51644.064
[GRAPHIC] [TIFF OMITTED] 51644.065
[GRAPHIC] [TIFF OMITTED] 51644.066
[GRAPHIC] [TIFF OMITTED] 51644.067
[GRAPHIC] [TIFF OMITTED] 51644.068
[GRAPHIC] [TIFF OMITTED] 51644.069
[GRAPHIC] [TIFF OMITTED] 51644.070
[GRAPHIC] [TIFF OMITTED] 51644.071
[GRAPHIC] [TIFF OMITTED] 51644.072
[GRAPHIC] [TIFF OMITTED] 51644.073
[GRAPHIC] [TIFF OMITTED] 51644.074
[GRAPHIC] [TIFF OMITTED] 51644.075
[GRAPHIC] [TIFF OMITTED] 51644.076
[GRAPHIC] [TIFF OMITTED] 51644.077
[GRAPHIC] [TIFF OMITTED] 51644.078
[GRAPHIC] [TIFF OMITTED] 51644.079
[GRAPHIC] [TIFF OMITTED] 51644.080
[GRAPHIC] [TIFF OMITTED] 51644.081
[GRAPHIC] [TIFF OMITTED] 51644.082
[GRAPHIC] [TIFF OMITTED] 51644.083
[GRAPHIC] [TIFF OMITTED] 51644.084
[GRAPHIC] [TIFF OMITTED] 51644.085
[GRAPHIC] [TIFF OMITTED] 51644.086
[GRAPHIC] [TIFF OMITTED] 51644.087
[GRAPHIC] [TIFF OMITTED] 51644.088
[GRAPHIC] [TIFF OMITTED] 51644.089
[GRAPHIC] [TIFF OMITTED] 51644.090
[GRAPHIC] [TIFF OMITTED] 51644.091
[GRAPHIC] [TIFF OMITTED] 51644.092
[GRAPHIC] [TIFF OMITTED] 51644.093
[GRAPHIC] [TIFF OMITTED] 51644.094
[GRAPHIC] [TIFF OMITTED] 51644.095
[GRAPHIC] [TIFF OMITTED] 51644.096
[GRAPHIC] [TIFF OMITTED] 51644.097
[GRAPHIC] [TIFF OMITTED] 51644.098
[GRAPHIC] [TIFF OMITTED] 51644.099
[GRAPHIC] [TIFF OMITTED] 51644.100
[GRAPHIC] [TIFF OMITTED] 51644.101
[GRAPHIC] [TIFF OMITTED] 51644.102
[GRAPHIC] [TIFF OMITTED] 51644.103
[GRAPHIC] [TIFF OMITTED] 51644.104
[GRAPHIC] [TIFF OMITTED] 51644.105
[GRAPHIC] [TIFF OMITTED] 51644.106
[GRAPHIC] [TIFF OMITTED] 51644.107
[GRAPHIC] [TIFF OMITTED] 51644.108
[GRAPHIC] [TIFF OMITTED] 51644.109
[GRAPHIC] [TIFF OMITTED] 51644.110
[GRAPHIC] [TIFF OMITTED] 51644.111
[GRAPHIC] [TIFF OMITTED] 51644.112
[GRAPHIC] [TIFF OMITTED] 51644.113
[GRAPHIC] [TIFF OMITTED] 51644.114
[GRAPHIC] [TIFF OMITTED] 51644.115
[GRAPHIC] [TIFF OMITTED] 51644.116
[GRAPHIC] [TIFF OMITTED] 51644.117
[GRAPHIC] [TIFF OMITTED] 51644.118
[GRAPHIC] [TIFF OMITTED] 51644.119
[GRAPHIC] [TIFF OMITTED] 51644.120
[GRAPHIC] [TIFF OMITTED] 51644.121
[GRAPHIC] [TIFF OMITTED] 51644.122
[GRAPHIC] [TIFF OMITTED] 51644.123
[GRAPHIC] [TIFF OMITTED] 51644.124
[GRAPHIC] [TIFF OMITTED] 51644.125
[GRAPHIC] [TIFF OMITTED] 51644.126
[GRAPHIC] [TIFF OMITTED] 51644.127
[GRAPHIC] [TIFF OMITTED] 51644.128
[GRAPHIC] [TIFF OMITTED] 51644.129
[GRAPHIC] [TIFF OMITTED] 51644.130
[GRAPHIC] [TIFF OMITTED] 51644.131
[GRAPHIC] [TIFF OMITTED] 51644.132
[GRAPHIC] [TIFF OMITTED] 51644.133
[GRAPHIC] [TIFF OMITTED] 51644.134
[GRAPHIC] [TIFF OMITTED] 51644.135
[GRAPHIC] [TIFF OMITTED] 51644.136
[GRAPHIC] [TIFF OMITTED] 51644.137
[GRAPHIC] [TIFF OMITTED] 51644.138
[GRAPHIC] [TIFF OMITTED] 51644.139
[GRAPHIC] [TIFF OMITTED] 51644.140
[GRAPHIC] [TIFF OMITTED] 51644.141
[GRAPHIC] [TIFF OMITTED] 51644.142
[GRAPHIC] [TIFF OMITTED] 51644.143
[GRAPHIC] [TIFF OMITTED] 51644.144
[GRAPHIC] [TIFF OMITTED] 51644.145
[GRAPHIC] [TIFF OMITTED] 51644.146
[GRAPHIC] [TIFF OMITTED] 51644.147
[GRAPHIC] [TIFF OMITTED] 51644.148
[GRAPHIC] [TIFF OMITTED] 51644.149
[GRAPHIC] [TIFF OMITTED] 51644.150
[GRAPHIC] [TIFF OMITTED] 51644.151
[GRAPHIC] [TIFF OMITTED] 51644.152
[GRAPHIC] [TIFF OMITTED] 51644.153
[GRAPHIC] [TIFF OMITTED] 51644.154
[GRAPHIC] [TIFF OMITTED] 51644.155
[GRAPHIC] [TIFF OMITTED] 51644.156
[GRAPHIC] [TIFF OMITTED] 51644.157
[GRAPHIC] [TIFF OMITTED] 51644.158
[GRAPHIC] [TIFF OMITTED] 51644.159
[GRAPHIC] [TIFF OMITTED] 51644.160
[GRAPHIC] [TIFF OMITTED] 51644.161
[GRAPHIC] [TIFF OMITTED] 51644.162
[GRAPHIC] [TIFF OMITTED] 51644.163
[GRAPHIC] [TIFF OMITTED] 51644.164
[GRAPHIC] [TIFF OMITTED] 51644.165
[GRAPHIC] [TIFF OMITTED] 51644.166
[GRAPHIC] [TIFF OMITTED] 51644.167
[GRAPHIC] [TIFF OMITTED] 51644.168
[GRAPHIC] [TIFF OMITTED] 51644.169
[GRAPHIC] [TIFF OMITTED] 51644.170
[GRAPHIC] [TIFF OMITTED] 51644.171
[GRAPHIC] [TIFF OMITTED] 51644.172
[GRAPHIC] [TIFF OMITTED] 51644.173
[GRAPHIC] [TIFF OMITTED] 51644.174
[GRAPHIC] [TIFF OMITTED] 51644.175
[GRAPHIC] [TIFF OMITTED] 51644.176
[GRAPHIC] [TIFF OMITTED] 51644.177
[GRAPHIC] [TIFF OMITTED] 51644.178
[GRAPHIC] [TIFF OMITTED] 51644.179
[GRAPHIC] [TIFF OMITTED] 51644.180
[GRAPHIC] [TIFF OMITTED] 51644.181
[GRAPHIC] [TIFF OMITTED] 51644.182
[GRAPHIC] [TIFF OMITTED] 51644.183
[GRAPHIC] [TIFF OMITTED] 51644.184
[GRAPHIC] [TIFF OMITTED] 51644.185
[GRAPHIC] [TIFF OMITTED] 51644.186
[GRAPHIC] [TIFF OMITTED] 51644.187
[GRAPHIC] [TIFF OMITTED] 51644.188
[GRAPHIC] [TIFF OMITTED] 51644.189
[GRAPHIC] [TIFF OMITTED] 51644.190
[GRAPHIC] [TIFF OMITTED] 51644.191
[GRAPHIC] [TIFF OMITTED] 51644.192
[GRAPHIC] [TIFF OMITTED] 51644.193
[GRAPHIC] [TIFF OMITTED] 51644.194
[GRAPHIC] [TIFF OMITTED] 51644.195
[GRAPHIC] [TIFF OMITTED] 51644.196
[GRAPHIC] [TIFF OMITTED] 51644.197
[GRAPHIC] [TIFF OMITTED] 51644.198
[GRAPHIC] [TIFF OMITTED] 51644.199
[GRAPHIC] [TIFF OMITTED] 51644.200
[GRAPHIC] [TIFF OMITTED] 51644.201
[GRAPHIC] [TIFF OMITTED] 51644.202
[GRAPHIC] [TIFF OMITTED] 51644.203
[GRAPHIC] [TIFF OMITTED] 51644.204
[GRAPHIC] [TIFF OMITTED] 51644.205
[GRAPHIC] [TIFF OMITTED] 51644.206
[GRAPHIC] [TIFF OMITTED] 51644.207
[GRAPHIC] [TIFF OMITTED] 51644.208
[GRAPHIC] [TIFF OMITTED] 51644.209
[GRAPHIC] [TIFF OMITTED] 51644.210
[GRAPHIC] [TIFF OMITTED] 51644.211
[GRAPHIC] [TIFF OMITTED] 51644.212
[GRAPHIC] [TIFF OMITTED] 51644.213
[GRAPHIC] [TIFF OMITTED] 51644.214
[GRAPHIC] [TIFF OMITTED] 51644.215
[GRAPHIC] [TIFF OMITTED] 51644.216
[GRAPHIC] [TIFF OMITTED] 51644.217
[GRAPHIC] [TIFF OMITTED] 51644.218
[GRAPHIC] [TIFF OMITTED] 51644.219
[GRAPHIC] [TIFF OMITTED] 51644.220
[GRAPHIC] [TIFF OMITTED] 51644.221
[GRAPHIC] [TIFF OMITTED] 51644.222
[GRAPHIC] [TIFF OMITTED] 51644.223
[GRAPHIC] [TIFF OMITTED] 51644.224
[GRAPHIC] [TIFF OMITTED] 51644.225
[GRAPHIC] [TIFF OMITTED] 51644.226
[GRAPHIC] [TIFF OMITTED] 51644.227
[GRAPHIC] [TIFF OMITTED] 51644.228
[GRAPHIC] [TIFF OMITTED] 51644.229
[GRAPHIC] [TIFF OMITTED] 51644.230
[GRAPHIC] [TIFF OMITTED] 51644.231
[GRAPHIC] [TIFF OMITTED] 51644.232
[GRAPHIC] [TIFF OMITTED] 51644.233
[GRAPHIC] [TIFF OMITTED] 51644.234
[GRAPHIC] [TIFF OMITTED] 51644.235
[GRAPHIC] [TIFF OMITTED] 51644.236
[GRAPHIC] [TIFF OMITTED] 51644.237
[GRAPHIC] [TIFF OMITTED] 51644.238
[GRAPHIC] [TIFF OMITTED] 51644.239
[GRAPHIC] [TIFF OMITTED] 51644.240
[GRAPHIC] [TIFF OMITTED] 51644.241
[GRAPHIC] [TIFF OMITTED] 51644.242
[GRAPHIC] [TIFF OMITTED] 51644.243
[GRAPHIC] [TIFF OMITTED] 51644.244
[GRAPHIC] [TIFF OMITTED] 51644.245
[GRAPHIC] [TIFF OMITTED] 51644.246
[GRAPHIC] [TIFF OMITTED] 51644.247
[GRAPHIC] [TIFF OMITTED] 51644.248
[GRAPHIC] [TIFF OMITTED] 51644.249
[GRAPHIC] [TIFF OMITTED] 51644.250
[GRAPHIC] [TIFF OMITTED] 51644.251
[GRAPHIC] [TIFF OMITTED] 51644.252
[GRAPHIC] [TIFF OMITTED] 51644.253
[GRAPHIC] [TIFF OMITTED] 51644.254
[GRAPHIC] [TIFF OMITTED] 51644.255
[GRAPHIC] [TIFF OMITTED] 51644.256
[GRAPHIC] [TIFF OMITTED] 51644.257
[GRAPHIC] [TIFF OMITTED] 51644.258
[GRAPHIC] [TIFF OMITTED] 51644.259
[GRAPHIC] [TIFF OMITTED] 51644.260
[GRAPHIC] [TIFF OMITTED] 51644.261
[GRAPHIC] [TIFF OMITTED] 51644.262
[GRAPHIC] [TIFF OMITTED] 51644.263
[GRAPHIC] [TIFF OMITTED] 51644.264
[GRAPHIC] [TIFF OMITTED] 51644.265
[GRAPHIC] [TIFF OMITTED] 51644.266
[GRAPHIC] [TIFF OMITTED] 51644.267
[GRAPHIC] [TIFF OMITTED] 51644.268
[GRAPHIC] [TIFF OMITTED] 51644.269
[GRAPHIC] [TIFF OMITTED] 51644.270
[GRAPHIC] [TIFF OMITTED] 51644.271
[GRAPHIC] [TIFF OMITTED] 51644.272
[GRAPHIC] [TIFF OMITTED] 51644.273
[GRAPHIC] [TIFF OMITTED] 51644.274
[GRAPHIC] [TIFF OMITTED] 51644.275
[GRAPHIC] [TIFF OMITTED] 51644.276
[GRAPHIC] [TIFF OMITTED] 51644.277
[GRAPHIC] [TIFF OMITTED] 51644.278
[GRAPHIC] [TIFF OMITTED] 51644.279
[GRAPHIC] [TIFF OMITTED] 51644.280
[GRAPHIC] [TIFF OMITTED] 51644.281
[GRAPHIC] [TIFF OMITTED] 51644.282
[GRAPHIC] [TIFF OMITTED] 51644.283
[GRAPHIC] [TIFF OMITTED] 51644.284
[GRAPHIC] [TIFF OMITTED] 51644.285
[GRAPHIC] [TIFF OMITTED] 51644.286
[GRAPHIC] [TIFF OMITTED] 51644.287
[GRAPHIC] [TIFF OMITTED] 51644.288
[GRAPHIC] [TIFF OMITTED] 51644.289
[GRAPHIC] [TIFF OMITTED] 51644.290
[GRAPHIC] [TIFF OMITTED] 51644.291
[GRAPHIC] [TIFF OMITTED] 51644.292
[GRAPHIC] [TIFF OMITTED] 51644.293
[GRAPHIC] [TIFF OMITTED] 51644.294
[GRAPHIC] [TIFF OMITTED] 51644.295
[GRAPHIC] [TIFF OMITTED] 51644.296
[GRAPHIC] [TIFF OMITTED] 51644.297
[GRAPHIC] [TIFF OMITTED] 51644.298
[GRAPHIC] [TIFF OMITTED] 51644.299
[GRAPHIC] [TIFF OMITTED] 51644.300
[GRAPHIC] [TIFF OMITTED] 51644.301
[GRAPHIC] [TIFF OMITTED] 51644.302
[GRAPHIC] [TIFF OMITTED] 51644.303
[GRAPHIC] [TIFF OMITTED] 51644.304
[GRAPHIC] [TIFF OMITTED] 51644.305
[GRAPHIC] [TIFF OMITTED] 51644.306
[GRAPHIC] [TIFF OMITTED] 51644.307
[GRAPHIC] [TIFF OMITTED] 51644.308
[GRAPHIC] [TIFF OMITTED] 51644.309
[GRAPHIC] [TIFF OMITTED] 51644.310
[GRAPHIC] [TIFF OMITTED] 51644.311
[GRAPHIC] [TIFF OMITTED] 51644.312
[GRAPHIC] [TIFF OMITTED] 51644.313
[GRAPHIC] [TIFF OMITTED] 51644.314
[GRAPHIC] [TIFF OMITTED] 51644.315
[GRAPHIC] [TIFF OMITTED] 51644.316
[GRAPHIC] [TIFF OMITTED] 51644.317
[GRAPHIC] [TIFF OMITTED] 51644.318
[GRAPHIC] [TIFF OMITTED] 51644.319
[GRAPHIC] [TIFF OMITTED] 51644.320
[GRAPHIC] [TIFF OMITTED] 51644.321
[GRAPHIC] [TIFF OMITTED] 51644.322
[GRAPHIC] [TIFF OMITTED] 51644.323
[GRAPHIC] [TIFF OMITTED] 51644.324
[GRAPHIC] [TIFF OMITTED] 51644.325
[GRAPHIC] [TIFF OMITTED] 51644.326
[GRAPHIC] [TIFF OMITTED] 51644.327
[GRAPHIC] [TIFF OMITTED] 51644.328
[GRAPHIC] [TIFF OMITTED] 51644.329
[GRAPHIC] [TIFF OMITTED] 51644.330
[GRAPHIC] [TIFF OMITTED] 51644.331
[GRAPHIC] [TIFF OMITTED] 51644.332
[GRAPHIC] [TIFF OMITTED] 51644.333
[GRAPHIC] [TIFF OMITTED] 51644.334
[GRAPHIC] [TIFF OMITTED] 51644.335
[GRAPHIC] [TIFF OMITTED] 51644.336
[GRAPHIC] [TIFF OMITTED] 51644.337
[GRAPHIC] [TIFF OMITTED] 51644.338
[GRAPHIC] [TIFF OMITTED] 51644.339
[GRAPHIC] [TIFF OMITTED] 51644.340
[GRAPHIC] [TIFF OMITTED] 51644.341
[GRAPHIC] [TIFF OMITTED] 51644.342
[GRAPHIC] [TIFF OMITTED] 51644.343
[GRAPHIC] [TIFF OMITTED] 51644.344
[GRAPHIC] [TIFF OMITTED] 51644.345
[GRAPHIC] [TIFF OMITTED] 51644.346
[GRAPHIC] [TIFF OMITTED] 51644.347
[GRAPHIC] [TIFF OMITTED] 51644.348
[GRAPHIC] [TIFF OMITTED] 51644.349
[GRAPHIC] [TIFF OMITTED] 51644.350
[GRAPHIC] [TIFF OMITTED] 51644.351
[GRAPHIC] [TIFF OMITTED] 51644.352
[GRAPHIC] [TIFF OMITTED] 51644.353
[GRAPHIC] [TIFF OMITTED] 51644.354
[GRAPHIC] [TIFF OMITTED] 51644.355
[GRAPHIC] [TIFF OMITTED] 51644.356
[GRAPHIC] [TIFF OMITTED] 51644.357
[GRAPHIC] [TIFF OMITTED] 51644.358
[GRAPHIC] [TIFF OMITTED] 51644.359
[GRAPHIC] [TIFF OMITTED] 51644.360
[GRAPHIC] [TIFF OMITTED] 51644.361
[GRAPHIC] [TIFF OMITTED] 51644.362
[GRAPHIC] [TIFF OMITTED] 51644.363
[GRAPHIC] [TIFF OMITTED] 51644.364
[GRAPHIC] [TIFF OMITTED] 51644.365
[GRAPHIC] [TIFF OMITTED] 51644.366
[GRAPHIC] [TIFF OMITTED] 51644.367
[GRAPHIC] [TIFF OMITTED] 51644.368
[GRAPHIC] [TIFF OMITTED] 51644.369
[GRAPHIC] [TIFF OMITTED] 51644.370
[GRAPHIC] [TIFF OMITTED] 51644.371
[GRAPHIC] [TIFF OMITTED] 51644.372
[GRAPHIC] [TIFF OMITTED] 51644.373
[GRAPHIC] [TIFF OMITTED] 51644.374
[GRAPHIC] [TIFF OMITTED] 51644.375
[GRAPHIC] [TIFF OMITTED] 51644.376
[GRAPHIC] [TIFF OMITTED] 51644.377
[GRAPHIC] [TIFF OMITTED] 51644.378
[GRAPHIC] [TIFF OMITTED] 51644.379
[GRAPHIC] [TIFF OMITTED] 51644.380
[GRAPHIC] [TIFF OMITTED] 51644.381
[GRAPHIC] [TIFF OMITTED] 51644.382
[GRAPHIC] [TIFF OMITTED] 51644.383
[GRAPHIC] [TIFF OMITTED] 51644.384
[GRAPHIC] [TIFF OMITTED] 51644.385
[GRAPHIC] [TIFF OMITTED] 51644.386
[GRAPHIC] [TIFF OMITTED] 51644.387
[GRAPHIC] [TIFF OMITTED] 51644.388
[GRAPHIC] [TIFF OMITTED] 51644.389
[GRAPHIC] [TIFF OMITTED] 51644.390
[GRAPHIC] [TIFF OMITTED] 51644.391
[GRAPHIC] [TIFF OMITTED] 51644.392
[GRAPHIC] [TIFF OMITTED] 51644.393
[GRAPHIC] [TIFF OMITTED] 51644.394
[GRAPHIC] [TIFF OMITTED] 51644.395
[GRAPHIC] [TIFF OMITTED] 51644.396
[GRAPHIC] [TIFF OMITTED] 51644.397
[GRAPHIC] [TIFF OMITTED] 51644.398
[GRAPHIC] [TIFF OMITTED] 51644.399
[GRAPHIC] [TIFF OMITTED] 51644.400
[GRAPHIC] [TIFF OMITTED] 51644.401
[GRAPHIC] [TIFF OMITTED] 51644.402
[GRAPHIC] [TIFF OMITTED] 51644.403
[GRAPHIC] [TIFF OMITTED] 51644.404
[GRAPHIC] [TIFF OMITTED] 51644.405
[GRAPHIC] [TIFF OMITTED] 51644.406
[GRAPHIC] [TIFF OMITTED] 51644.407
[GRAPHIC] [TIFF OMITTED] 51644.408
[GRAPHIC] [TIFF OMITTED] 51644.409
[GRAPHIC] [TIFF OMITTED] 51644.410
[GRAPHIC] [TIFF OMITTED] 51644.411
[GRAPHIC] [TIFF OMITTED] 51644.412
[GRAPHIC] [TIFF OMITTED] 51644.413
[GRAPHIC] [TIFF OMITTED] 51644.414
[GRAPHIC] [TIFF OMITTED] 51644.415
[GRAPHIC] [TIFF OMITTED] 51644.416
[GRAPHIC] [TIFF OMITTED] 51644.417
[GRAPHIC] [TIFF OMITTED] 51644.418
[GRAPHIC] [TIFF OMITTED] 51644.419
[GRAPHIC] [TIFF OMITTED] 51644.420
[GRAPHIC] [TIFF OMITTED] 51644.421
[GRAPHIC] [TIFF OMITTED] 51644.422
[GRAPHIC] [TIFF OMITTED] 51644.423
[GRAPHIC] [TIFF OMITTED] 51644.424
[GRAPHIC] [TIFF OMITTED] 51644.425
[GRAPHIC] [TIFF OMITTED] 51644.426
[GRAPHIC] [TIFF OMITTED] 51644.427
[GRAPHIC] [TIFF OMITTED] 51644.428
[GRAPHIC] [TIFF OMITTED] 51644.429
[GRAPHIC] [TIFF OMITTED] 51644.430
[GRAPHIC] [TIFF OMITTED] 51644.431
[GRAPHIC] [TIFF OMITTED] 51644.432
[GRAPHIC] [TIFF OMITTED] 51644.433
[GRAPHIC] [TIFF OMITTED] 51644.434
[GRAPHIC] [TIFF OMITTED] 51644.435
[GRAPHIC] [TIFF OMITTED] 51644.436
[GRAPHIC] [TIFF OMITTED] 51644.437
[GRAPHIC] [TIFF OMITTED] 51644.438
[GRAPHIC] [TIFF OMITTED] 51644.439
[GRAPHIC] [TIFF OMITTED] 51644.440
[GRAPHIC] [TIFF OMITTED] 51644.441
[GRAPHIC] [TIFF OMITTED] 51644.442
[GRAPHIC] [TIFF OMITTED] 51644.443
[GRAPHIC] [TIFF OMITTED] 51644.444
[GRAPHIC] [TIFF OMITTED] 51644.445
[GRAPHIC] [TIFF OMITTED] 51644.446
[GRAPHIC] [TIFF OMITTED] 51644.447
[GRAPHIC] [TIFF OMITTED] 51644.448
[GRAPHIC] [TIFF OMITTED] 51644.449
[GRAPHIC] [TIFF OMITTED] 51644.450
[GRAPHIC] [TIFF OMITTED] 51644.451
[GRAPHIC] [TIFF OMITTED] 51644.452
[GRAPHIC] [TIFF OMITTED] 51644.453
[GRAPHIC] [TIFF OMITTED] 51644.454
[GRAPHIC] [TIFF OMITTED] 51644.455
[GRAPHIC] [TIFF OMITTED] 51644.456
[GRAPHIC] [TIFF OMITTED] 51644.457
[GRAPHIC] [TIFF OMITTED] 51644.458
[GRAPHIC] [TIFF OMITTED] 51644.459
[GRAPHIC] [TIFF OMITTED] 51644.460
[GRAPHIC] [TIFF OMITTED] 51644.461
[GRAPHIC] [TIFF OMITTED] 51644.462
[GRAPHIC] [TIFF OMITTED] 51644.463
[GRAPHIC] [TIFF OMITTED] 51644.464
[GRAPHIC] [TIFF OMITTED] 51644.465
[GRAPHIC] [TIFF OMITTED] 51644.466
[GRAPHIC] [TIFF OMITTED] 51644.467
[GRAPHIC] [TIFF OMITTED] 51644.468
[GRAPHIC] [TIFF OMITTED] 51644.469
[GRAPHIC] [TIFF OMITTED] 51644.470
[GRAPHIC] [TIFF OMITTED] 51644.471
[GRAPHIC] [TIFF OMITTED] 51644.472
[GRAPHIC] [TIFF OMITTED] 51644.473
[GRAPHIC] [TIFF OMITTED] 51644.474
[GRAPHIC] [TIFF OMITTED] 51644.475
[GRAPHIC] [TIFF OMITTED] 51644.476
[GRAPHIC] [TIFF OMITTED] 51644.477
[GRAPHIC] [TIFF OMITTED] 51644.478
[GRAPHIC] [TIFF OMITTED] 51644.479
[GRAPHIC] [TIFF OMITTED] 51644.480
[GRAPHIC] [TIFF OMITTED] 51644.481
[GRAPHIC] [TIFF OMITTED] 51644.482
[GRAPHIC] [TIFF OMITTED] 51644.483
[GRAPHIC] [TIFF OMITTED] 51644.484
[GRAPHIC] [TIFF OMITTED] 51644.485
[GRAPHIC] [TIFF OMITTED] 51644.486
[GRAPHIC] [TIFF OMITTED] 51644.487
[GRAPHIC] [TIFF OMITTED] 51644.488
[GRAPHIC] [TIFF OMITTED] 51644.489
[GRAPHIC] [TIFF OMITTED] 51644.490
[GRAPHIC] [TIFF OMITTED] 51644.491
[GRAPHIC] [TIFF OMITTED] 51644.492
[GRAPHIC] [TIFF OMITTED] 51644.493
[GRAPHIC] [TIFF OMITTED] 51644.494
[GRAPHIC] [TIFF OMITTED] 51644.495
[GRAPHIC] [TIFF OMITTED] 51644.496
[GRAPHIC] [TIFF OMITTED] 51644.497
[GRAPHIC] [TIFF OMITTED] 51644.498
[GRAPHIC] [TIFF OMITTED] 51644.499
[GRAPHIC] [TIFF OMITTED] 51644.500
[GRAPHIC] [TIFF OMITTED] 51644.501
[GRAPHIC] [TIFF OMITTED] 51644.502
[GRAPHIC] [TIFF OMITTED] 51644.503
[GRAPHIC] [TIFF OMITTED] 51644.504
[GRAPHIC] [TIFF OMITTED] 51644.505
[GRAPHIC] [TIFF OMITTED] 51644.506
[GRAPHIC] [TIFF OMITTED] 51644.507
[GRAPHIC] [TIFF OMITTED] 51644.508
[GRAPHIC] [TIFF OMITTED] 51644.509
[GRAPHIC] [TIFF OMITTED] 51644.510
[GRAPHIC] [TIFF OMITTED] 51644.511
[GRAPHIC] [TIFF OMITTED] 51644.512
[GRAPHIC] [TIFF OMITTED] 51644.513
[GRAPHIC] [TIFF OMITTED] 51644.514
[GRAPHIC] [TIFF OMITTED] 51644.515
[GRAPHIC] [TIFF OMITTED] 51644.516
[GRAPHIC] [TIFF OMITTED] 51644.517
[GRAPHIC] [TIFF OMITTED] 51644.518
[GRAPHIC] [TIFF OMITTED] 51644.519
[GRAPHIC] [TIFF OMITTED] 51644.520
[GRAPHIC] [TIFF OMITTED] 51644.521
[GRAPHIC] [TIFF OMITTED] 51644.522
[GRAPHIC] [TIFF OMITTED] 51644.523
[GRAPHIC] [TIFF OMITTED] 51644.524
[GRAPHIC] [TIFF OMITTED] 51644.525
[GRAPHIC] [TIFF OMITTED] 51644.526
[GRAPHIC] [TIFF OMITTED] 51644.527
[GRAPHIC] [TIFF OMITTED] 51644.528
[GRAPHIC] [TIFF OMITTED] 51644.529
[GRAPHIC] [TIFF OMITTED] 51644.530
[GRAPHIC] [TIFF OMITTED] 51644.531
[GRAPHIC] [TIFF OMITTED] 51644.532
[GRAPHIC] [TIFF OMITTED] 51644.533
[GRAPHIC] [TIFF OMITTED] 51644.534
[GRAPHIC] [TIFF OMITTED] 51644.535
[GRAPHIC] [TIFF OMITTED] 51644.536
[GRAPHIC] [TIFF OMITTED] 51644.537
[GRAPHIC] [TIFF OMITTED] 51644.538
[GRAPHIC] [TIFF OMITTED] 51644.539
[GRAPHIC] [TIFF OMITTED] 51644.540
[GRAPHIC] [TIFF OMITTED] 51644.541
[GRAPHIC] [TIFF OMITTED] 51644.542
[GRAPHIC] [TIFF OMITTED] 51644.543
[GRAPHIC] [TIFF OMITTED] 51644.544
[GRAPHIC] [TIFF OMITTED] 51644.545
[GRAPHIC] [TIFF OMITTED] 51644.546
[GRAPHIC] [TIFF OMITTED] 51644.547
[GRAPHIC] [TIFF OMITTED] 51644.548
[GRAPHIC] [TIFF OMITTED] 51644.549
[GRAPHIC] [TIFF OMITTED] 51644.550
[GRAPHIC] [TIFF OMITTED] 51644.551
[GRAPHIC] [TIFF OMITTED] 51644.552
[GRAPHIC] [TIFF OMITTED] 51644.553
[GRAPHIC] [TIFF OMITTED] 51644.554
[GRAPHIC] [TIFF OMITTED] 51644.555
[GRAPHIC] [TIFF OMITTED] 51644.556
[GRAPHIC] [TIFF OMITTED] 51644.557
[GRAPHIC] [TIFF OMITTED] 51644.558
[GRAPHIC] [TIFF OMITTED] 51644.559
[GRAPHIC] [TIFF OMITTED] 51644.560
[GRAPHIC] [TIFF OMITTED] 51644.561
[GRAPHIC] [TIFF OMITTED] 51644.562
[GRAPHIC] [TIFF OMITTED] 51644.563
[GRAPHIC] [TIFF OMITTED] 51644.564
[GRAPHIC] [TIFF OMITTED] 51644.565
[GRAPHIC] [TIFF OMITTED] 51644.566
[GRAPHIC] [TIFF OMITTED] 51644.567
[GRAPHIC] [TIFF OMITTED] 51644.568
[GRAPHIC] [TIFF OMITTED] 51644.569
[GRAPHIC] [TIFF OMITTED] 51644.570
[GRAPHIC] [TIFF OMITTED] 51644.571
[GRAPHIC] [TIFF OMITTED] 51644.572
[GRAPHIC] [TIFF OMITTED] 51644.573
[GRAPHIC] [TIFF OMITTED] 51644.574
[GRAPHIC] [TIFF OMITTED] 51644.575
[GRAPHIC] [TIFF OMITTED] 51644.576
[GRAPHIC] [TIFF OMITTED] 51644.577
[GRAPHIC] [TIFF OMITTED] 51644.578
[GRAPHIC] [TIFF OMITTED] 51644.579
[GRAPHIC] [TIFF OMITTED] 51644.580
[GRAPHIC] [TIFF OMITTED] 51644.581
[GRAPHIC] [TIFF OMITTED] 51644.582
[GRAPHIC] [TIFF OMITTED] 51644.583
[GRAPHIC] [TIFF OMITTED] 51644.584
[GRAPHIC] [TIFF OMITTED] 51644.585
[GRAPHIC] [TIFF OMITTED] 51644.586
[GRAPHIC] [TIFF OMITTED] 51644.587
[GRAPHIC] [TIFF OMITTED] 51644.588
[GRAPHIC] [TIFF OMITTED] 51644.589
[GRAPHIC] [TIFF OMITTED] 51644.590
[GRAPHIC] [TIFF OMITTED] 51644.591
[GRAPHIC] [TIFF OMITTED] 51644.592
[GRAPHIC] [TIFF OMITTED] 51644.593
[GRAPHIC] [TIFF OMITTED] 51644.594
[GRAPHIC] [TIFF OMITTED] 51644.595
[GRAPHIC] [TIFF OMITTED] 51644.596
[GRAPHIC] [TIFF OMITTED] 51644.597
[GRAPHIC] [TIFF OMITTED] 51644.598
[GRAPHIC] [TIFF OMITTED] 51644.599
[GRAPHIC] [TIFF OMITTED] 51644.600
[GRAPHIC] [TIFF OMITTED] 51644.601
[GRAPHIC] [TIFF OMITTED] 51644.602
[GRAPHIC] [TIFF OMITTED] 51644.603
[GRAPHIC] [TIFF OMITTED] 51644.604
[GRAPHIC] [TIFF OMITTED] 51644.605
[GRAPHIC] [TIFF OMITTED] 51644.606
[GRAPHIC] [TIFF OMITTED] 51644.607
[GRAPHIC] [TIFF OMITTED] 51644.608
[GRAPHIC] [TIFF OMITTED] 51644.609
[GRAPHIC] [TIFF OMITTED] 51644.610
[GRAPHIC] [TIFF OMITTED] 51644.611
[GRAPHIC] [TIFF OMITTED] 51644.612
[GRAPHIC] [TIFF OMITTED] 51644.613
[GRAPHIC] [TIFF OMITTED] 51644.614
[GRAPHIC] [TIFF OMITTED] 51644.615
[GRAPHIC] [TIFF OMITTED] 51644.616
[GRAPHIC] [TIFF OMITTED] 51644.617
[GRAPHIC] [TIFF OMITTED] 51644.618
[GRAPHIC] [TIFF OMITTED] 51644.619
[GRAPHIC] [TIFF OMITTED] 51644.620
[GRAPHIC] [TIFF OMITTED] 51644.621
[GRAPHIC] [TIFF OMITTED] 51644.622
[GRAPHIC] [TIFF OMITTED] 51644.623
[GRAPHIC] [TIFF OMITTED] 51644.624
[GRAPHIC] [TIFF OMITTED] 51644.625
[GRAPHIC] [TIFF OMITTED] 51644.626
[GRAPHIC] [TIFF OMITTED] 51644.627
[GRAPHIC] [TIFF OMITTED] 51644.628
[GRAPHIC] [TIFF OMITTED] 51644.629
[GRAPHIC] [TIFF OMITTED] 51644.630
[GRAPHIC] [TIFF OMITTED] 51644.631
[GRAPHIC] [TIFF OMITTED] 51644.632
[GRAPHIC] [TIFF OMITTED] 51644.633
[GRAPHIC] [TIFF OMITTED] 51644.634
[GRAPHIC] [TIFF OMITTED] 51644.635
[GRAPHIC] [TIFF OMITTED] 51644.636
[GRAPHIC] [TIFF OMITTED] 51644.637
[GRAPHIC] [TIFF OMITTED] 51644.638
[GRAPHIC] [TIFF OMITTED] 51644.639
[GRAPHIC] [TIFF OMITTED] 51644.640
[GRAPHIC] [TIFF OMITTED] 51644.641
[GRAPHIC] [TIFF OMITTED] 51644.642
[GRAPHIC] [TIFF OMITTED] 51644.643
[GRAPHIC] [TIFF OMITTED] 51644.644
[GRAPHIC] [TIFF OMITTED] 51644.645
[GRAPHIC] [TIFF OMITTED] 51644.646
[GRAPHIC] [TIFF OMITTED] 51644.647
[GRAPHIC] [TIFF OMITTED] 51644.648
[GRAPHIC] [TIFF OMITTED] 51644.649
[GRAPHIC] [TIFF OMITTED] 51644.650
[GRAPHIC] [TIFF OMITTED] 51644.651
[GRAPHIC] [TIFF OMITTED] 51644.652
[GRAPHIC] [TIFF OMITTED] 51644.653
[GRAPHIC] [TIFF OMITTED] 51644.654
[GRAPHIC] [TIFF OMITTED] 51644.655
[GRAPHIC] [TIFF OMITTED] 51644.656
[GRAPHIC] [TIFF OMITTED] 51644.657
[GRAPHIC] [TIFF OMITTED] 51644.658
[GRAPHIC] [TIFF OMITTED] 51644.659
[GRAPHIC] [TIFF OMITTED] 51644.660
[GRAPHIC] [TIFF OMITTED] 51644.661
[GRAPHIC] [TIFF OMITTED] 51644.662
[GRAPHIC] [TIFF OMITTED] 51644.663
[GRAPHIC] [TIFF OMITTED] 51644.664
[GRAPHIC] [TIFF OMITTED] 51644.665
[GRAPHIC] [TIFF OMITTED] 51644.666
[GRAPHIC] [TIFF OMITTED] 51644.667
[GRAPHIC] [TIFF OMITTED] 51644.668
[GRAPHIC] [TIFF OMITTED] 51644.669
[GRAPHIC] [TIFF OMITTED] 51644.670
[GRAPHIC] [TIFF OMITTED] 51644.671
[GRAPHIC] [TIFF OMITTED] 51644.672
[GRAPHIC] [TIFF OMITTED] 51644.673
[GRAPHIC] [TIFF OMITTED] 51644.674
[GRAPHIC] [TIFF OMITTED] 51644.675
[GRAPHIC] [TIFF OMITTED] 51644.676
[GRAPHIC] [TIFF OMITTED] 51644.677
[GRAPHIC] [TIFF OMITTED] 51644.678
[GRAPHIC] [TIFF OMITTED] 51644.679
[GRAPHIC] [TIFF OMITTED] 51644.680
[GRAPHIC] [TIFF OMITTED] 51644.681
[GRAPHIC] [TIFF OMITTED] 51644.682
[GRAPHIC] [TIFF OMITTED] 51644.683
[GRAPHIC] [TIFF OMITTED] 51644.684
[GRAPHIC] [TIFF OMITTED] 51644.685
[GRAPHIC] [TIFF OMITTED] 51644.686
[GRAPHIC] [TIFF OMITTED] 51644.687
[GRAPHIC] [TIFF OMITTED] 51644.688
[GRAPHIC] [TIFF OMITTED] 51644.689
[GRAPHIC] [TIFF OMITTED] 51644.690
[GRAPHIC] [TIFF OMITTED] 51644.691
[GRAPHIC] [TIFF OMITTED] 51644.692
[GRAPHIC] [TIFF OMITTED] 51644.693
[GRAPHIC] [TIFF OMITTED] 51644.694
[GRAPHIC] [TIFF OMITTED] 51644.695
[GRAPHIC] [TIFF OMITTED] 51644.696
[GRAPHIC] [TIFF OMITTED] 51644.697
[GRAPHIC] [TIFF OMITTED] 51644.698
[GRAPHIC] [TIFF OMITTED] 51644.699
[GRAPHIC] [TIFF OMITTED] 51644.700
[GRAPHIC] [TIFF OMITTED] 51644.701
[GRAPHIC] [TIFF OMITTED] 51644.702
[GRAPHIC] [TIFF OMITTED] 51644.703
[GRAPHIC] [TIFF OMITTED] 51644.704
[GRAPHIC] [TIFF OMITTED] 51644.705
[GRAPHIC] [TIFF OMITTED] 51644.706
[GRAPHIC] [TIFF OMITTED] 51644.707
[GRAPHIC] [TIFF OMITTED] 51644.708
[GRAPHIC] [TIFF OMITTED] 51644.709
[GRAPHIC] [TIFF OMITTED] 51644.710
[GRAPHIC] [TIFF OMITTED] 51644.711
[GRAPHIC] [TIFF OMITTED] 51644.712
[GRAPHIC] [TIFF OMITTED] 51644.713
[GRAPHIC] [TIFF OMITTED] 51644.714
[GRAPHIC] [TIFF OMITTED] 51644.715
[GRAPHIC] [TIFF OMITTED] 51644.716
[GRAPHIC] [TIFF OMITTED] 51644.717
[GRAPHIC] [TIFF OMITTED] 51644.718
[GRAPHIC] [TIFF OMITTED] 51644.719
[GRAPHIC] [TIFF OMITTED] 51644.720
[GRAPHIC] [TIFF OMITTED] 51644.721
[GRAPHIC] [TIFF OMITTED] 51644.722
[GRAPHIC] [TIFF OMITTED] 51644.723
[GRAPHIC] [TIFF OMITTED] 51644.724
[GRAPHIC] [TIFF OMITTED] 51644.725
[GRAPHIC] [TIFF OMITTED] 51644.726
[GRAPHIC] [TIFF OMITTED] 51644.727
[GRAPHIC] [TIFF OMITTED] 51644.728
[GRAPHIC] [TIFF OMITTED] 51644.729
[GRAPHIC] [TIFF OMITTED] 51644.730
[GRAPHIC] [TIFF OMITTED] 51644.731
[GRAPHIC] [TIFF OMITTED] 51644.732
[GRAPHIC] [TIFF OMITTED] 51644.733
[GRAPHIC] [TIFF OMITTED] 51644.734
[GRAPHIC] [TIFF OMITTED] 51644.735
[GRAPHIC] [TIFF OMITTED] 51644.736
[GRAPHIC] [TIFF OMITTED] 51644.737
[GRAPHIC] [TIFF OMITTED] 51644.738
[GRAPHIC] [TIFF OMITTED] 51644.739
[GRAPHIC] [TIFF OMITTED] 51644.740
[GRAPHIC] [TIFF OMITTED] 51644.741
[GRAPHIC] [TIFF OMITTED] 51644.742
[GRAPHIC] [TIFF OMITTED] 51644.743
[GRAPHIC] [TIFF OMITTED] 51644.744
[GRAPHIC] [TIFF OMITTED] 51644.745
[GRAPHIC] [TIFF OMITTED] 51644.746
[GRAPHIC] [TIFF OMITTED] 51644.747
[GRAPHIC] [TIFF OMITTED] 51644.748
[GRAPHIC] [TIFF OMITTED] 51644.749
[GRAPHIC] [TIFF OMITTED] 51644.750
[GRAPHIC] [TIFF OMITTED] 51644.751
[GRAPHIC] [TIFF OMITTED] 51644.752
[GRAPHIC] [TIFF OMITTED] 51644.753
[GRAPHIC] [TIFF OMITTED] 51644.754
[GRAPHIC] [TIFF OMITTED] 51644.755
[GRAPHIC] [TIFF OMITTED] 51644.756
[GRAPHIC] [TIFF OMITTED] 51644.757
[GRAPHIC] [TIFF OMITTED] 51644.758
[GRAPHIC] [TIFF OMITTED] 51644.759
[GRAPHIC] [TIFF OMITTED] 51644.760
[GRAPHIC] [TIFF OMITTED] 51644.761
[GRAPHIC] [TIFF OMITTED] 51644.762
[GRAPHIC] [TIFF OMITTED] 51644.763
[GRAPHIC] [TIFF OMITTED] 51644.764
[GRAPHIC] [TIFF OMITTED] 51644.765
[GRAPHIC] [TIFF OMITTED] 51644.766
[GRAPHIC] [TIFF OMITTED] 51644.767
[GRAPHIC] [TIFF OMITTED] 51644.768
[GRAPHIC] [TIFF OMITTED] 51644.769
[GRAPHIC] [TIFF OMITTED] 51644.770
[GRAPHIC] [TIFF OMITTED] 51644.771
[GRAPHIC] [TIFF OMITTED] 51644.772
[GRAPHIC] [TIFF OMITTED] 51644.773
[GRAPHIC] [TIFF OMITTED] 51644.774
[GRAPHIC] [TIFF OMITTED] 51644.775
[GRAPHIC] [TIFF OMITTED] 51644.776
[GRAPHIC] [TIFF OMITTED] 51644.777
[GRAPHIC] [TIFF OMITTED] 51644.778
[GRAPHIC] [TIFF OMITTED] 51644.779
[GRAPHIC] [TIFF OMITTED] 51644.780
[GRAPHIC] [TIFF OMITTED] 51644.781
[GRAPHIC] [TIFF OMITTED] 51644.782
[GRAPHIC] [TIFF OMITTED] 51644.783
[GRAPHIC] [TIFF OMITTED] 51644.784
[GRAPHIC] [TIFF OMITTED] 51644.785
[GRAPHIC] [TIFF OMITTED] 51644.786
[GRAPHIC] [TIFF OMITTED] 51644.787
[GRAPHIC] [TIFF OMITTED] 51644.788
[GRAPHIC] [TIFF OMITTED] 51644.789
[GRAPHIC] [TIFF OMITTED] 51644.790
[GRAPHIC] [TIFF OMITTED] 51644.791
[GRAPHIC] [TIFF OMITTED] 51644.792
[GRAPHIC] [TIFF OMITTED] 51644.793
[GRAPHIC] [TIFF OMITTED] 51644.794
[GRAPHIC] [TIFF OMITTED] 51644.795
[GRAPHIC] [TIFF OMITTED] 51644.796
[GRAPHIC] [TIFF OMITTED] 51644.797
[GRAPHIC] [TIFF OMITTED] 51644.798
[GRAPHIC] [TIFF OMITTED] 51644.799
[GRAPHIC] [TIFF OMITTED] 51644.800
[GRAPHIC] [TIFF OMITTED] 51644.801
[GRAPHIC] [TIFF OMITTED] 51644.802
[GRAPHIC] [TIFF OMITTED] 51644.803
[GRAPHIC] [TIFF OMITTED] 51644.804
[GRAPHIC] [TIFF OMITTED] 51644.805
[GRAPHIC] [TIFF OMITTED] 51644.806
[GRAPHIC] [TIFF OMITTED] 51644.807
[GRAPHIC] [TIFF OMITTED] 51644.808
[GRAPHIC] [TIFF OMITTED] 51644.809
[GRAPHIC] [TIFF OMITTED] 51644.810
[GRAPHIC] [TIFF OMITTED] 51644.811
[GRAPHIC] [TIFF OMITTED] 51644.812
[GRAPHIC] [TIFF OMITTED] 51644.813
[GRAPHIC] [TIFF OMITTED] 51644.814
[GRAPHIC] [TIFF OMITTED] 51644.815
[GRAPHIC] [TIFF OMITTED] 51644.816
[GRAPHIC] [TIFF OMITTED] 51644.817
[GRAPHIC] [TIFF OMITTED] 51644.818
[GRAPHIC] [TIFF OMITTED] 51644.819
[GRAPHIC] [TIFF OMITTED] 51644.820
[GRAPHIC] [TIFF OMITTED] 51644.821
[GRAPHIC] [TIFF OMITTED] 51644.822
[GRAPHIC] [TIFF OMITTED] 51644.823
[GRAPHIC] [TIFF OMITTED] 51644.824
[GRAPHIC] [TIFF OMITTED] 51644.825
[GRAPHIC] [TIFF OMITTED] 51644.826
[GRAPHIC] [TIFF OMITTED] 51644.827
[GRAPHIC] [TIFF OMITTED] 51644.828
[GRAPHIC] [TIFF OMITTED] 51644.829
[GRAPHIC] [TIFF OMITTED] 51644.830
[GRAPHIC] [TIFF OMITTED] 51644.831
[GRAPHIC] [TIFF OMITTED] 51644.832
[GRAPHIC] [TIFF OMITTED] 51644.833
[GRAPHIC] [TIFF OMITTED] 51644.834
[GRAPHIC] [TIFF OMITTED] 51644.835
[GRAPHIC] [TIFF OMITTED] 51644.836
[GRAPHIC] [TIFF OMITTED] 51644.837
[GRAPHIC] [TIFF OMITTED] 51644.838
[GRAPHIC] [TIFF OMITTED] 51644.839
[GRAPHIC] [TIFF OMITTED] 51644.840
[GRAPHIC] [TIFF OMITTED] 51644.841
[GRAPHIC] [TIFF OMITTED] 51644.842
[GRAPHIC] [TIFF OMITTED] 51644.843
[GRAPHIC] [TIFF OMITTED] 51644.844
[GRAPHIC] [TIFF OMITTED] 51644.845
[GRAPHIC] [TIFF OMITTED] 51644.846
[GRAPHIC] [TIFF OMITTED] 51644.847
[GRAPHIC] [TIFF OMITTED] 51644.848
[GRAPHIC] [TIFF OMITTED] 51644.849
[GRAPHIC] [TIFF OMITTED] 51644.850