Identify yourself, please.

MR. BROWN: Cooper Brown, National Committee for Radiation Victims.

Todd, what I want to do was follow up on the comments you made, but before I do, I just would like to say something about the comments that had been made earlier by Dr. O=Toole.

What was said yesterday, I am concerned that people aren=t hearing this and they are going to be hearing it more, I think, from just based on the discussions we are having inside the task force, is that the issue is not medical surveillance, the issue is medical health care and that is different. All right. And the way we look at it is, the question comes down, it is a fundamental question and it was a question that was resolved for the atomic veterans to the atomic veterans benefit. That is who bears the cost? You talk about costs, we can=t afford it, well, somebody else is bearing the costs right now and that is the person who has been put at risk. So the issue is who bears the costs? The people who are put at risk or the party who put them at risk?

As I say, with the atomic veterans, Congress changed the law, that was one of the first laws that got changed, way back when in 1988 or something, it says, if you are an atomic veteran and you show up at VA hospital, we will provide you with medical care. Now, there is a big debate, I don=t want to pretend that the health care that they get through the VA is all that good, but nevertheless, a fundamental acknowledgment, AWe put these people at risk. We will provide health care.@ And that is the issue, and that is the thrust, I think, you are going to hear more and more coming from the task force.

Now, moving on to Todd=s comments. Todd, you reminded me of Senator Rockerfellows= response a couple of years ago to the Gulf War issue, with regard to, you know, the use of experimental drugs on the Gulf War vets. That reminded, we have had a concern and it is not ours alone, because it is expressed by the Advisory Committee, that rules and regulations and development of policy in the end doesn=t mean squiggly. The problems, you know, they are good rules, good regulations, adoption of the Nuremberg Code and yet all this stuff happens. Now, what is the Advisory Committee=s response? More of the same. Excuse me, is anybody listening to what the Advisory Committee said earlier on?

The way we are looking at it, members of the Task Force, is if you want to stop the, if you want to ensure that what happened during the Cold War years does not happen in the future, then you have to start talking about fundamental institutional change. That is the only way you are going to get around it. You hear people talking about criminal sanctions, that should be looked at not only in terms of retribution to those who it was done to before, but you have got to look at in terms of if you don=t impose criminal sanctions, where criminal sanctions are clearly warranted. And you know, the Advisory Committee notes at least two incidents where they think people were killed as a result of the experimentation. And says but there has to be further investigation. If you don=t respond to that, you are sending absolutely the wrong message to people who decide to do experimentation in the future.

The other thing is, remedies. Access to justice. There are solvent immunity defenses that are put in place to protect the government when they, when they, well, when they kill people, thank you, when they engage in this type of conduct. The Task Force has been saying that in this, at least in this one limited situation, where the Government engages in or sponsors illegal human experimentation, there should be no solvent immunity that can stand in the way of the right of the individual who has been wronged, having his day in court against the perpetrator.

MR. ENSIGN: Cooper, try to conclude, will you?

MR. BROWN: Okay. And that gets to Rockerfellow in that that is just not a, that is not just a task force position, Senator Rockerfellow two years ago said that that should be the Government=s response to this business about the FDA licensing experimental drugs on veterans.

MR. ENSIGN: Just one 30 second point of privilege here, because it was kind of implied by the two gentlemen responding that somehow that these vaccines that were issued, were somehow, I think the implication was they were effective and in the Rockerfellow report, which is well worth anyone here reading, this is our Veterans Affairs, Senate Veterans Affairs Committee Report, cast serious doubt on the effacy of these, of the pertigmebomine, in fact, it was given at doses that wouldn=t have protected people. It wouldn=t protect you against two of the gases that were known to be in Hussein=s arsenal. And the committee, it is really a devastating critique, saying, AMy God, they took this great risk, and it didn=t even protect the troops.@ So, we are talking here about a process. That is the reason why you can=t rush into these things and allow this kind of willy nilly waiver of these rules. That is a very good argument for it.

We have, David, Dr. Egilman did ask to speak. Please, David, try to be very brief. He feels that he has, that he was, he wants to respond to Dr. O=Toole=s personal --

DR. EGILMAN: Misrepresentation.

MR. ENSIGN: Okay. But, please, David, try to, we have got --

DR. EGILMAN: I will be very quick.

MR. ENSIGN: Be brief.

DR. EGILMAN: My response yesterday was to talk to Galson=s misrepresentation of medical monitoring and applying it, involved biopsies and extra radiation. I wanted to make it clear that those are extreme ridiculous examples. No one is abrillum exposed cohort in this group, no one is suggesting it that you get, and that is really not a biopsy as she knows, that is a bronchosity, which is a different procedure. It does involve, perhaps a biopsy, but it certainly not the biopsy that a lay person would understand, first.

Second issue is, second issue is the skinny needle biopsy that you would do after an echo is not a very invasive procedure. It is a benign procedure. And if you don=t want to take my word for that, why don=t you ask Dr. Selman, in the back. I practice medicine, I don=t talk about it, I have a regular practice. And I do these things on patients when it is indicated.

The main --

MR. ENSIGN: David.

DR. EGILMAN: Fine. Do either of you have got a medical practice --

MR. ENSIGN: David, David, please. Try to conclude, okay. Make your concluding point.

DR. EGILMAN: Thanks.

The point is and let me give you the suggested solution, medical care, through Medicare would allow people to pick their own doctor. Is it an administratively fast aisle solution, can be justified because these people are of a unique class, a class that could be added to the Medicare system. It wouldn=t be, no pay, because there is a co-pay with Medicare for those qualify. And if you wanted to do medical follow-up, then you could use that system, that health care system and voluntarily medical release, with some kind of a joint research panel, that would allow for follow-up, it you wanted to collect data. That is something that is a method that could be used in the future as well as in the past, as suggested method for dealing with people if there has been a wrong that occurs from now on. That one of the remedies for future wrongs would be if you wrong someone, in a medical experiment, one of your obligations is to then provide then with medical care, generally, even if you don=t think medically harmed them, it is a remedy for the wrong.

MR. BAILEY: Colonel Bailey. Dr. Galson would like to make some comments.

DR. GALSON: Very, very quickly. Steve Galson.

MR. BAILEY: Very briefly we will go to a break.

DR. GALSON: Okay. Okay, real quick.

We worked very closely with Cooper and colleagues to plan this meeting. I never understood in those preparations that the issue of medical surveillance versus medical care was going to be discussed here. We don=t have the right people in this room. We don=t have people from Medicare. We don=t have people from ATSTR. We don=t have the right people to discuss that issue. It is very complex. I agree it is a big problem. I think a lot of this money could be better spent rather than on studies, on perhaps providing Medicare. There are some people in the Government who have been working very hard to get these kind of programs started. We never thought this was going to be issue at this meeting. I don=t really think it is fair play to bring it up. We weren=t prepared and we don=t have the right people here to discuss it.

MR. BAILEY: We have one more person, Sandy Reid, from Oak Ridge.

MS. REID: First of all, Doctor, you set the agenda, you know, we were trying to come forward with ideas that were concerns. We knew the medical issue was going to be an important one. There are many of us that feel very strongly. They are many of us who feel very strongly about it now.

The thing is that one has to recognize is that there is a benefit for evaluating early medical diseases other than cancer, such as with thyroid problems, hypothyroid, from some of these intentional releases, can that be picked up, right now it could be. Could it have been picked up 25 years ago, maybe not. But, there is a benefit to it. What are the side effects? You can have children that have dimenses intellectual ability. You have many other side effects from not treating someone with thyroid problems. So there are significant changes in medicine that we could address right now, with adequate medical evaluation, treatment and monitoring of these people.

I want to make it clear to, Tara, I know you understand these problems. You did an enormous amount of work in complex clean-up and hazardous ahead. And yet we have come to you repeatedly from my community with worker health and safety issues. I have written you letters personally, asking your assistance in addressing some of the exposures and it is not done.

The facilities are studied, not the people. And as I said to you once at a meeting and you laughed at me, was that I think you have given the rights and privilege of an American citizen to the contaminants and they are innocent until we prove them guilty. And the people are not helped.

MR. BAILEY: With those comments, thank you very kindly.

MS. REID: And not you, Tara, I mean the system.

MR. BAILEY: I have got you.

With those comments, we will take a, come back at 10:05.

(Whereupon, a short recess was taken.)

MS. CAMPOS-INFANTINO: Half of you weren=t here when we went over this morning. So I will do this briefly.

We have a lot of people today on this particular panel. So it is going to be really important to, in order to keep the dialogue constructive, that we adhere to the ground rules that we talked about earlier. Use common courtesy and it is just fine to have conflict and debate on the issues, that is what we are here about. If everybody had the same opinion, we wouldn=t be in the room. But, let=s try to refrain from making personal attacks, because that is not helpful and it shuts people down.

Let=s listen actively to each other so we clearly understand what is said and not read into what is said. And if you are not sure about what is stated, then ask clarifying question. That is a good way of verifying whether you got the right message or not, rather than getting really upset from hearing that may not be, have been conveyed clearly.

Then when you make your points, try to speak clearly and identify your concern, identify differences in view point between what you are stating and what you have heard. And identify ways that your concerns can be addressed. We have captured a lot of real concrete ideas today. I am documenting what I can in summary fashion on these flip chart paper. So, that people who wish to address specific issues, will have them to look at. I am trying to post them so that the panelists can see them, since they are the ones engaging in the dialogue primarily. Okay. I will turn it over to Eva.

MS. PLAZA: Good morning. My name is Eva Plaza. I work at the Department of Justice. I am the Deputy Assistant Attorney General. And this morning we have a very, very packed panel of experts and constituent groups that all need to speak and I am sure that there are more in the audience. So, I am going to leave the substance of this panel to the experts and I will try to moderate and I will try to keep things moving along.

I would ask all of our panelists, first let me introduce them to you. We have three topics, as you know, we have uranium miners, Marshall Islanders and Alaskan natives to talk about this morning, in this panel. And we are going to go in the order designated. First we are going to talk about the recommendation number seven of the Advisory Committee, and discuss the issues relating to uranium miners. Next, and we are going to go through the panel discussion, through some question and answer period. And we are going to introduce some discussion leaders who have also joined us up here today.

Then we are going move on. After we have exhausted that particular topic, we are going to move on to Marshall Islanders and talk about that topic. We will have a panel discussion, followed by questions and answers and a discussion period with our discussion leaders up here.

And then finally, we are going to move Alaskan natives and talk about that subject. So that once we have moved to the next subject, you know that we have exhausted the subject. We don=t have a lot of time and we have a lot of people who want to give us their views.

First of all, I want to introduce Paul Yanowitch from the Department of Justice, an attorney in the Environmental Tort Section. Then we have Rick Hornung, who is Acting Director of Energy Related Health Research at NIOSH. And then we have Dr. Jonathan Samet, from the School of Hygiene and Public in Health in Johns Hopkins University. And finally, Phil Harrison, from the Navaho Tribe. And these four gentlemen are going to talk about the first issue in our agenda today, the uranium miners.

Next, we are going to go to Thomas Bell, who is Director of Health Physics Program Division in the Office of Health Services in the Department of Energy. Then we have Banny deBrum, who is the Ambassador Designate of the Marshall Islands. And these two gentlemen are going to talk about our Marshall Islanders issue.

And then we are going to move onto Dan Brown. Mr. Dan Brown is the Chief of Clinical Investigations in the Office of Surgeon General in the Air Force. And then Mr. Dennis Roper, at the very end, is a special assistant to the Mayor George Ahmaogak. Ahmaogak, Senior Alaskan North Slope Borough. And then we have some discussion leaders, people who are very knowledgeable about these three issues back here. We have Tim Benally, back there with the Navaho Indians. And we have Manual Pino, from the Pueblo of Laguna. And we have a couple of other individuals who are not up here, but are going to join us in the audience.

I oversee the Radiation Exposure Compensation Act Program and I probably shouldn=t say that publicly. But, we are in the process of implementing some suggested changes and looking into the science and really looking at the recommendation number seven. And here to talk about what we have done and what we are doing and what the Act is about and the Advisory Committee=s recommendations is Paul Yanowitch.

MR. YANOWITCH: Thank you very much, Ms. Plaza.

I would like to talk very briefly this morning, I guess to set the background.

I am sorry, no one has ever told me I haven=t been loud enough.

I would like to talk briefly to set the background up about the Radiation Exposure Compensation Act, why I am here and the Committee, which I am involved in, which Dr. Hornung is also involved in and then I will leave the scientific data to Dr. Samet or Dr. Hornung, who are the experts.

We are here in connection with recommendation seven of the Advisory Committee, President=s Advisory Committee, which most of you was directed to the uranium miner provisions of the Radiation Exposure Compensation Act of 1990. The Act, itself, was set up as most of you know, to compensate three groups of individuals, who presumably were injured as a result of the Government=s nuclear testing program during the Cold War. Downwinders, individuals who live downwind of the Nevada test site, onsite participants, individuals who, as most of you know, the Department of Energy and DOD personnel who were at the Nevada test site or the specific test site and the group concerned today, which we are concerned today, the uranium miners, which the Act defines compensation or provides that individuals who mined in undergran uranium mines, between 1947 and 1971, who were exposed to certain minimum levels of radiation, as radon is measured in something called working level months, and who contracted certain specific diseases, are entitled to compensation under this Act. And the miners are entitled to $100,000.00 or their beneficiaries, descendants.

The Advisory Committee reviewed the Act and its administration. The Act is administered by the Department of Justice, which wrote some regulations to implement the Act back in 1990 or 1991. And the Advisory Committee as you can see in recommendation seven, felt that there were at least two general problems with the Act, or this is our interpretation.

The first is they felt that, I will take one step back. Pardon me for the digression. But, the Act with regard to uranium miners provides that they are entitled to compensation if, as I said, they can prove exposure to minimum levels of radiation. The Act defines those levels of radiation. And it defines three specific levels, distinguishing among uranium miners by their smoking history. That is whether they were a smoker or non smoker and the age of incidents of the particular disease, the compensable disease. And the two groups of diseases which are compensated, are lung cancer, and -- Well, that is not a group, but lung cancer and a group of diseases referred to as non malignant respiratory diseases such as silicosis, fibrosis, things of that type.

And the Act sets specific radiation levels, depending upon whether you were a smoker in the age of incident of disease. The President=s Advisory Committee reviewed the latest credible scientific data, the latest epidemiological data of uranium miners. And concluded that, (1) that there was a significant problem potentially that the Act=s specific levels, the radiation levels established in the Act, were not consistent with the latest credible scientific data, or so they concluded.

And therefore, their principal recommendation to the President was that or at least the Interagency Working Group, was to examine the Act and determine whether these radiation levels, these exposure levels truly were consistent with the latest data and if not, to recommend changes to Congress, to work with Congress to modify the Act to ensure that all eligible miners, those who had been exposed to significant amounts of radiation and contracted lung cancer or a non malignant respiratory disease as a result of that exposure, that they were compensated.

The Advisory Committee also heard testimony that the Act=s administration, the regulations implementing the Act, may have imposed or may impose some unreasonable and unnecessary requirements, documentation requirements, particularly, which were making it difficult for many eligible miners, particularly Native Americans, to be compensated.

In response to the recommendation seven, which I believe is included in your packet, so I won=t read it, in response to that recommendation, the Interagency Working Group asked the Attorney General to set up a committee, to examine these questions. And through Ms. Plaza, whose responsibility to form and oversee this committee, a committee has been set up of Government scientists and a few attorneys to examine these problems. The committee is seven people, four Government scientists, three Department of Justice attorneys. I am one of the attorneys, Dr. Hornung here is one of the Government scientists. And the four Government scientists on here, I should point out are all individuals with extensive experience in either the diseases at issue or the uranium mining population. Particularly Dr. Hornung and Dr. Luben, from National Cancer Institute, who are on the committee, are two along with Dr. Samet, are two of the leading researchers on the uranium mining population. And have spent most of their professional careers studying this population and the incident of disease. We are very fortunate have the experts in the country and in the world, on our panel.

So, what we have done, this committee has been set up and we are trying to examine, just in conclusion these general questions. What does the latest credible scientific data establish with the causation between exposure to radon, radiation in the mines and the diseases? To examine the Act=s requirements to determine and ensure that the requirements in the Act do compensate those miners whose lung cancer and non malignant respiratory disease was caused by their mining experience. And to examine the regulations enacted by the Department some years ago to determine whether it is imposing unreasonable and oppressive burdens on miners in applying for compensation.

And I am here along with Dr. Hornung to hope, to welcome any comments about problems and criticisms of the Act and the regulations and to hope that we can learn a lot more about that from people who have obviously spent some time examining the Act and are familiar with its administration, so we can recommend changes if appropriate.

And with that, I would like to turn it over, if that is okay, to Dr. Hornung, who is a member of the committee and will talk something about this new scientific data and the reason why the Advisory Committee recommended it to the present Attorney General that our little committee be formed.

Thank you.

DR. HORNUNG: Thank you, Paul.

My name is Rick Hornung, I am with the National Institute for Occupational Safety and Health. I think there is a probably two reasons I am here. The first as Paul said, I am a member of the committee that is looking into the revisions of the criteria for the RECA Act. The other is that I have been involved for approximately 15 years in research in the study that NIOSH has done on the uranium miners in the Southwest.

Contrary to what we have heard yesterday and this morning, where there is a lot of controversy with regard to some of these other associations between various types of radiation and other maybe, chemical exposures, and various disease outcomes, there really is very little controversy over the relationship between radon, the K product exposure, and lung cancer. We heard a lot about inconclusive studies. Some people think they maybe deliberately inconclusive. The nice thing about this research is there never has been an inclusive study relating radon, at least in miners, radon and lung cancer. It is very well established. What we are really about now in the science end of things is what levels of radiation or radon exposure, caused what degree of risks to lung cancer.

Probably the two most recent studies that Paul was mentioning, that enhance our scientific view of things, are a recent update of that cohort that NIOSH is following, which is about 4,000 miners in Utah, Arizona, Colorado, and New Mexico. And that study is probably the longest running NIOSH study. It actually started before NIOSH came into being. NIOSH came into being in 1971. This study was initiated in 1950. We now have additional smoking data and an additional vital status follow-up through the end of 1990. There is unfortunately additional lung cancer cases but with the increased data that we have, we have a bit, a better picture of what is going on.

In addition to that study, there is a much larger study that has recently been completed of 11 different cohorts. Study groups throughout the world, not just in the United States, that included about 68,000 miners and over 2,000 lung cancer cases. So, some of you, I think, have mentioned that some of these studies are inconclusive, because they are very small. This is a very large study that gives us even more precision in looking into these different risk estimates.

Based on these studies, we were able recalculate what is normally referred to as probability of causation. Given that you are exposed to a level of radon, what is the probability that, of your risk of dying of lung cancer? It turns out that when we did these calculations, the current as Paul sort of eluded to, the current criteria for compensation appear to be too stringent. That is normally these things are set at a probability causation of about 50 percent more likely than not that you died due to your exposure in the mines. And that those probabilities are much higher based on the newer scientific evidence.

So, I think there is general agreement on the committee that these standards need to be revised and need to be relaxed somewhat. The exact nature of that, we are still under deliberation. We are still in the middle of a series of meetings.

The current criteria as you know and as Paul mentioned, are based on age, exposure measured in WLM and cigarette smoking, all these are on the table for us. The Department of Justice has told us, we want the best available evidence to drive this and if anything in the Act doesn=t make sense scientifically, you are free to criticize that or recommend a different criteria.

So, I think rather than, I could spend an hour talking about the various analyses and various sort of estuary findings, I would rather spend or give some of my time to the other members of the panel, to voice their concerns. But, as Paul said, I think what we would like to hear is from you, is the concerns you have about the current criteria. And I think the process actually is designed so that we will come up with a draft recommendation and then go out to other members of the scientific community as well as the stakeholders, the miners, themselves and get their input as to what they think about a revised set of criteria that we may come up with.

So, with that I think I will stop and let other members of the panel speak.

MS. PLAZA: Okay. Dr. Jonathan Samet.

DR. SAMET: Thank you. My name is Jonathan Samet. While I am currently at Johns Hopkins University. I spent much of my career at the University of New Mexico School of Medicine, where I was Chief of Pulmonary Medicine and also devoted a great deal of my time to research on the health consequences of uranium mining. There I saw firsthand, miners with radiation related lung cancers, as well as non malignant respiratory diseases. This is a real problem and there is no question that the uranium miners throughout the world will bear a tremendous burden of disease.

I was pleased then when the Radiation Exposure Compensation Act passed as it acknowledged the Federal Government=s role and set in motion a system for compensation. However, it was also clear very early that the provisions were flawed. As Rick mentioned, the exposures were set at remarkably high level and a penalty was inappropriately imposed on smokers. The provisions for non malignant lung disease, particularly silicosis, were inadequate. Experiences proved that implementation has been difficult. There are inadequacies of the existing data base, particularly related to exposures that miners received in the past. We are talking about records of work experience, dating back to the late 1940s and the requirements of the Act for documenting specific exposures are simply difficult to meet because of gaps and a very long historical record.

Additionally, past medical documentation may not be adequate and there are simply difficult diagnosis to make for some of the entities of concern.

Thus, I certainly concur with the recommendation that the Act be revisited and revised. I think particularly as the committee considers its work, it will be important to look carefully at whether exposure requirements should be kept, given the inadequacies of the historical data base and whether other criteria perhaps based simply on proof of having worked underground during the requisite time period, should be considered.

The probability of causation would represent a step forward, but, again, if based on a requirement that individual exposures be estimated, the same problem of error and gaps would arise.

Again, I think any arbitrary choice at a specific level of probability for causation would demand a careful review in light of what values might be leading to that particular cut point.

I would also agree with any steps that removes the smoker penalty and since we have so much more experience now in this large data base, that Rick mentioned, that really should be used to guide the development of the provisions of the Act. I think we can do better.

Now, I understand we are here to talk about radiation, but uranium mining involves exposures other than radon prodigy, blasting fumes, diesel exhaust and silicone. And there are non malignant respiratory diseases, associated with mining. The intent of the Act was to offer an apology to those miners who had been exposed to hazardous substances underground. And I think that to date the problem of radon and lung cancer has been overly emphasized and insufficient attention been given to the more difficult problem of the non malignant respiratory diseases. So I would again hope that this will be taken on.

Finally, there is one other large group of individuals who the Act has neglected, the uranium millers, remember that the fuel cycle process involved extraction of the uranium in the formation of yellow cake or U-308 at mills located relatively near to the mine sites. The millers had complex exposures, including exposure to radon, depending on their particular job. So, I think, again, while not mentioned in the report or in the recommendation, I think it is well recognized that the uranium millers, who were also producing uranium for the Atomic Energy Commission, were, have been forgotten to date. The millers know they are forgotten, of course. So, I think with the passage of the Act in 1990, it was an important step forward. And I think now with experience gained, with the current provisions of the Act, the complexity of implementing and I am pleased that we are taking the time to look carefully at how to make things work better.