108th ACNW Meeting U.S. Nuclear Regulatory Commission, March 24, 1999
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION *** 108TH ADVISORY COMMITTEE ON NUCLEAR WASTE (ACNW) Nuclear Regulatory Commission Room 2B3 Two White Flint North 11545 Rockville Pike Rockville, Maryland Wednesday, March 24, 1999 The above-entitled meeting, commenced, pursuant to notice at 8:31 a.m. MEMBERS PRESENT: DR. JOHN B. GARRICK, Chairman, ACNW DR. GEORGE W. HORNBERGER, Vice Chairman, ACNW DR. CHARLES FAIRHURST, Member, ACNW DR. RAYMOND G. WYMER, Member, ACNW. P R O C E E D I N G S [8:31 a.m.] DR. GARRICK: Good morning. I believe it's Wednesday, March 24th, 1999. Our meeting will now come to order. This is the second day of the 108th meeting of the Advisory Committee on Nuclear Waste. My name is John Garrick, Chairman, ACNW. Other members of the committee include George Hornberger, Ray Wymer and Charles Fairhurst. We will re-welcome and re-introduce our two consultants, Dr. Otto Raabe and Dr. Kim Kearfott -- and we also continue to welcome the member of our sister company and that is the Chairman of our sister company, Dr. Dana Powers. Today the committee will continue our discussions on low levels of ionizing radiation and allow the public to hear their views on the presentations we heard yesterday. We have some other business to do. We will meet with John Greeves, NRC's Director, Division of Waste Management, to discuss developments at Yucca Mountain, rules and guidance under development, resources and other sources of mutual interest. We will review progress on the development of a clearance rule for materials and equipment having residual radioactive contamination, and we will review the status of the Decommissioning Standard Review Plan. Mr. Howard Larson is the Designated Federal Official for the initial portion of today's meeting and as usual this meeting is being conducted in accordance with the provisions of the Federal Advisory Committee Act. Aside from the announcements we made yesterday regarding people who wish to make remarks and comments, we have received no other written statements or requests from members of the public regarding today's session. Should anyone wish to address the committee, please make your wishes known to some member of the Staff and as usual we appeal to you because of the need for recording your valuable words to use a microphone, identify yourself, and speak with clarity and volume so that we can hear your message. So I think where we are today we are going to continue our discussion, continue to hear from selected numbers of people and hopefully advance this thing to a point where we have a basis for developing some sort of a letter or report for the Commission, and with that I will turn it back over to our lead member on this subject, Ray Wymer. DR. WYMER: Thank you, John. I think the appropriate way to start this out for the benefit of the people who may -- there may be a few -- who weren't here yesterday, to state what the purpose of this meeting is, what we hope to accomplish. The purpose of the meeting is to update the Advisory Committee on Nuclear Waste with respect to the research and some of the debate regarding the linear non-threshold hypothesis so that the Advisory Committee can advise the Nuclear Regulatory Commission on actions related to the LNT as applied to radiation risk of low level ionizing radiation. That is our purpose and in addition we wanted to maintain a high level of visibility of this very important topic in the Commission and in the public at large because we think it is a very important issue, one with profound financial implications as well as health implications. This morning we will continue with discussion from the audience with respect to their points of view and their interests and points they want to make in this area of LNT and following up on the procedure of yesterday, I want to turn it over to Michael Halus, who was facilitating yesterday's panel discussion and who will also facilitate the discussions this morning. Mike? MR. HALUS: To reidentify the purpose for this particular portion of the meeting, that is, the panel discussion, the purpose is to further explore the issues associated with LNT with a view towards searching for gaps in the research and identify further actions for consideration and recommendation to the Commission. We have invited people to make presentations on it. I would ask people to constrain their remarks to a 20-minute time period so everyone who chooses to present will have time to do that -- so is there anyone in the audience who would like to make a presentation? They are certainly welcome to do that. Who would like to go first? MR. ROCKWELL: Theodore Rockwell. DR. GARRICK: Ted, you may want to go up here -- we can see your wonderful physique better that way. MR. ROCKWELL: Thanks. First of all, I want to say that Ted Quinn, who is the President of American Nuclear Society wanted very much to be here and he called me at midnight last night. He was still trying to get a later flight out to Rochester, which I guess there aren't a lot of them, and he didn't make it, but he asked me to convey the concern of the American Nuclear Society on the importance of this issue and the tremendous burden that it puts on nuclear technology to have to concern itself with these minuscule levels and defend the fact when we are in a position of saying we don't know whether we are killing people at one or two MR per year. Incidentally, I got an e-mail last night from Zbignieu Jaworowski of the Polish Central Laboratory in Radiation and he told me the 48th UNSCEAR session will be held in Vienna from 12-16 April. I am preparing myself for it 100 percent of my time and he is -- they are going to consider Cohen's work is specifically on the thing and other epidemiological subjects relating to LNT and the whole basis for the assumption of accumulating dose and so forth, and he has got a paper here that he wants us to look over that he wants to send out to the committee members ahead of time for their consideration on this whole business of collecting LNT doses and pointing out how absurd it is, and the way the thing is worded now and the way they are doing it is that they want the sum of all annual doses over all the years in which exposures continue over infinite time to account for exposures occurring to all future time from the average individual dose over all generations. He plays this thing out all the way back to homo erectus and homo habilis -- [Laughter.] MR. ROCKWELL: -- and points out that the billions and billions of manrem that have been built up over that situation and the .00000 contribution of anything we can do, and says for gosh sake, fellas, let's knock this off. I hope that any consideration you give you will recognize that you are not alone in this thing. There are a lot of people -- the concern is building up that this is -- I mean there comes a time when you have to say that the thing has reached a ridiculous point. The other question -- this contract for this report, as I understand, was under Regulatory Research, is that right, John? DR. GARRICK: The NCRP -- MS. THOMAS: Yes, the NCRP 1.6 was through Research. MR. ROCKWELL: Yes. Is there anyone here from Research that is responsible for this report? Has anyone been here to say whether -- MS. THOMAS: Shlomo? DR. YANIV: I know that Vince Holahan -- MS. THOMAS: Yes, Vince Holahan is on military assignment at this point in time. He was the PM for this project. MR. ROCKWELL: Well, do we know whether the people who paid for this report feel that it answers the concerns that they had that were expressed in the '96 meeting that the thing would consider all of the data and that the questions that have been raised in the past have been satisfactorily answered and so forth? Is anybody here to answer that question? DR. YANIV: I can answer my personal -- MS. THOMAS: Shlomo? DR. GARRICK: Use a microphone. DR. YANIV: My name is Shlomo Yaniv and I am with the Office of Research. Now the comments that I am going to make at this point are my personal ones, having read the draft report. I have not prepared any remarks. I was impressed by the scientific quality of the report, the depths of analysis and I consider the report to be a report on the state of the art of science in all aspects of radiobiology from molecular to human epidemiology including animal research, et cetera. Obviously it cannot answer all the questions that we would like to have the answer for reasons that have to do with the nature of the science and the state of the science, but it is an extremely good picture of the state of the knowledge for the professional. It is not an easy read and my personal opinion, that the conclusions drawn in the draft report are correct. MR. ROCKWELL: Are you satisfied that the concerns that were raised three years ago by this committee and others that have come in where specific questions were raised that this is not valid because, this is not valid correctly handled -- are you satisfied that all those concerns that have been specifically raised on the record have been handled? DR. YANIV: As I said, I have not prepared, I have not reviewed anything prior to our conversation and I am not familiar with the specifics that you right now ask or maybe don't remember at the moment so I cannot answer that in an affirmative nor negative. MR. ROCKWELL: But before the report is finally approved for issuance, is anyone going to look over -- these concerns have been presented before to this committee, to the NCRP. People have gotten up and testified. Matter of fact, we have had concerns expressed to us that we have heard all this stuff before. You have. The question is has it been responded to and if it is not going to be responded to now, do you plan to go over these things and assure yourself -- DR. YANIV: I cannot answer that question. I am not the Project Manager. I am a Staff member and as I said I am expressing at this point my personal opinion. You are getting into policy which I cannot answer. MR. ROCKWELL: John, I assume that that will be addressed in your letter? DR. GARRICK: Well, we are going to review everything we have heard and it will be the basis for our letter, that's right. MR. ROCKWELL: Okay. Well, let me turn this over to Jim Muckerheide or to Myron -- either one -- whichever of you guys want to -- what we want to do is to try to make clear the nature of the concerns that we have and specifically why -- I mean yesterday we only had minutes and what we said was these things, these comments that we have made have not been concerned and Arthur Upton got up and said sure they have, and then he went on to the next topic. We would like to get more specific as to why we feel that these have not been raised, why they are substantive, and why they should be approached. MR. HALUS: For timekeeping purposes, we will go ahead and start the 20 minute time period with the new speaker. MR. MUCKERHEIDE: I wasn't so much anticipating making a presentation as pointing out some of the questions that we would like to pursue. In responding to the presentation yesterday by Dr. Upton, it seemed to me that we have the classic example of having a number of slides that represent the linear response that you get when you hit cells with radiation, and they are cells in petri dishes that have no biological systems that are immune-response, et cetera, and so you bring out that data and say, see, it is a linear response. It doesn't include cells that show non-linear responses. A lot of the slides start at a relatively high dose, even if it is only 1 rem per day, which is very low dose in high dose studies, but there is no data that goes below the 1 rem per day. And so you end up with this presentation that says here is another straight line. In addition, the data that shows cell and chromosome effects, we know from the radiation workers in the U.K. that have been followed from the wind scale fire, the high dose group, they can see chromosome effects in that population. There is no associated health effects. That is true in general, high doses are going to have more chromosome aberrations, but, in general, a chromosome aberration is a dead end and it doesn't necessarily mean there are health effects. In fact, in animals that show beneficial effects, you can see excess chromosome aberrations. So the fact that they presented a lot of data from the biology literature that shows these kinds of effects, and yet it still comes out with the same old straight line selected data continues to exist. He made a statement about double-strand breaks as being normal activity is one in 25 years or something like that, on one of the slides. Unfortunately, we didn't get any handouts, so I am not sure that I remember this accurately, but I was thunderstruck at that number. It is clearly not part of what biology represents, although radiation has a higher percentage of double-strand breaks than single-strand breaks compared to normal biological metabolism, it is certainly nothing like one per 25 years. Double-strand breaks are frequent in normal metabolism and representing that they aren't is clearly contrary to the current knowledge of biology. We had a number of presentations that showed responses from neutrons, et cetera. That is, of course, not really relevant to anything that we care about in low dose radiation response. There was a statement I thought that was very instructive about radium-226 as being the one thing we really know has a threshold, and, of course, we have all known since the late '60s, early '70s, that the threshold is about 1000r, and in this case we have radium-226 as a threshold. I was interested in asking Dr. Pushkin about why the fact that we already have radium-226 limits that are 125,000 times lower than that threshold, why they are now still going through a rulemaking to further reduce radium-226 limits in drinking water and why we went through a whole exercise with radium-226 groundwater contamination in New Jersey, with fears that were going to be damaging people because they had more than 5 picocuries per liter. The State of Wisconsin, the high dose, where the high concentration area is in Wisconsin, Iowa, et cetera, are going through now the fact that they may spend additional millions of dollars to deal with the fact that they have radium in drinking water that is higher than the limits, and the new limits would add more millions of dollars, and, yet, in this presentation yesterday, we acknowledged that that is one of the very specific cases where the linear threshold doesn't apply, or the linear nonthreshold doesn't apply. You were going to say -- DR. GARRICK: No, no. MR. MUCKERHEIDE: Oh, I'm sorry. There was a presentation on leukemia in the atomic bomb survivor studies that typically ignores the low dose data point that was left off of one of the 1988 studies and has consistently in the literature been pointed out that the actual leukemia data in the lifespan studies is inconsistent with how it was presented in Shimizu '88. The fluoroscopy data that was presented ignored the fluoroscopy study of the Canadian women, except for the high dose group in one part of the study, but not the other part of the study. It has been pointed out for years, since Ted Webster pointed it out on publication of the original article, that the data is highly indicative of hormetic response for breast cancer. It is also highly indicative of a response for lung cancer. It was known at the time of BEIR V, and yet it is the -- in the actual summary of BEIR V, it is the second most significant study after the lifespan survivor study in the document in terms of a person rem year, and is relied on enormously for a straight line that is generated, has straight line over a low dose decrement of one-third for the breast cancer rate in that population. More reference was made to the Cardis study of the U.K., U.S. and Canadian workers, a study that basically misrepresents its own data. The study authors, after having published the study, and finally gotten some criticism for the fact that they had come out in saying this shows a linear response, several of the authors refused to make that statement, yet the NCRP has continued to make it, and even to characterize it as vindicating the linear model. And in that study, it is clear that the only one cancer of the couple of dozen that is in there, in a 1 out of 20 test, has 6 cases of leukemia versus 2.3 expected for greater than 40r dose group, and on the basis of that one data point, draws a straight line to zero, discounting all of the data in between. We show no such indication, and, therefore, the Cardis study, in its own presentation, misrepresented its own data. And as Myron has always pointed out, as long as you take 1P values, then you essentially ignore all the data points below the line. Out of the seven groups, you only have three that are above the line, and it happens to be that the one at the end is high, so in 15,000 deaths, you have 6 versus 2.3 in a greater than 40 rem dose group, and now the whole study demonstrates and proves the linear model, and it gets referenced as though it does. And that has been documented, it is documented in the Los Alamos Science magazine. It has been documented in the literature. I mean it is not as though this is, you know, somebody's underground railroad, this material was presented to NCRP, and they are well aware of. It has been presented not just for this report, but before that. It came out in meetings that we had in '95. I want to pass over the Cohen data. I did want to make one point though about the characterization of Cohen's data as though it were an anomaly and somehow the result of one man's extraordinary treatment of this data. If we go back to '87 when Cohen first took a look at Cumberland County, Pennsylvania, and found that this highest-radon county in his neighborhood had very low lung cancer rates, and he compared seven other studies that indicated -- around the world that indicated similar kinds of results -- those kinds of studies were then published in a number of places, and so we've really known about this since before '87 really. Cohen kind of pulled this together in '87 in the Health Physics Journal. He did two or three other interim studies, not all of which just literally led to the 1995 conclusion by the time he had all of the data that was so dramatic, but a number of studies are included and all consistently reflecting the same kind of relationship. But in addition to Cohen, you know, small studies and minor efforts, but looking at the whole U.S. population all shows the same relationship. You know, there's a tendency to think well, Cohen went out and did all these measurements and there may be some self-selection. Well, last year Bogen at Lawrence Livermore looked at just the EPA's data on the radon based on the environmental measurements, and those environmental measurements were correlated with residential radon concentrations. But if you take the environmental measurements over the whole U.S. and correlate it with the American Cancer Society's statistics on lung cancer, and he looked at the women lung cancer deaths, 1950 to 1954 as another set, but because the women from 40 to 80 years old had 11-percent smoking frequency and 4-percent smoking frequency in the women 60 to 80 years old, and when he looks at that he gets another curve just like Cohen's, totally independent in any way, shape, or form from Cohen's analysis and the way he got his data and the way he made the analysis. When Jaeger published and simply said hey, we're going to take the high-dose States and the low-dose States and see this enormous discrepancy, and it's very highly statistically significant. Sandquist at Utah in '96 did a cut at the data just on the EPA regions and looked at radiation in terms of the EPA regions based on the EPA's own cut at the radon in the country, and they got the same results. They found that the lung cancer rate at the highest-dose region was 14 percent of the EPA predictions, and the lung cancer rate at the lowest-dose region was 390 percent of the EPA prediction, and that if you take each region in between it's a consistent relationship. I mean, this is not an anomalous kind of situation. And yet BEIR VI itself treats Cohen as a nut on the fringe and misrepresents his data in the curve and characterizes that in a paragraph to simply say well, some people would think this might represent that there isn't a significant effect, and they leave it at that. And then they go about and they say we do a model that basically draws a straight line and that's the end of it. And so this whole process continues. I commented yesterday that Norm Frigario, who I knew in the seventies, and one of the reasons I got exposed -- no pun intended, I guess -- to this whole subject was when we were paying attention in '72 to Calvert Cliffs and Appendix I, Appendix D, all the initial efforts because of the new NEPA standards and writing environmental reports. I was working for Bechtel at the time. AEC contracted with Argonne to do a low-dose study specifically in response to Calvert Cliffs and a court's decision that you didn't do a good enough job, and as a licensing initiative they made a contract and Argonne did a study just to say here we have a population that's exposed to low-dose radiation in the same terms and conditions that we're concerned about in terms of chronic exposure at low rates, and we have significant differences or significant enough differences, but we don't have nitty-gritty detail data, we only have fairly coarse numbers about radon -- or radiation. So just not including the lung cancer dose, just looking at the radiation -- external radiation numbers -- this characterization that of course Colorado is lower and the Southeast of the U.S. is higher in terms of all cancers, and doing a number of socioeconomic confounding factors assessments, this first cut at the data was a negative. Well, that report was issued by Argonne to AEC in '73, and that project was killed by Regulatory Research or the equivalent of Regulatory Research in the AEC at the time. And Norm Frigario eventually got that "published" by going to an IAEA conference on low-dose radiation, because he couldn't get it published otherwise, and it came out as a proceedings paper. So it was a brief kind of form. And that was referred to in BEIR III, and dismissed in two paragraphs. It was brought up as an UNSCAER 1977 document that was suppressed at UNSCAER by the UNSCAER process that said well, we really don't know if this is serious. But nobody went back and looked at the fundamental analysis that was done on the Argonne study, they all just said well, we got this one little paper in a proceedings and that's what we're going to build our decision on. And before Norm died in '78, '79, he was completely convinced that the characterization and the inability to get the document published was simply a result of the commitment to LNT. At this meeting in '96, that meeting of the subcommittee in '96, Charlie Willis, who recently died here at the offices as I understand actually being here overnight made a statement -- MR. HALUS: You have five more minutes. MR. MUCKERHEIDE: Made a statement that said I came to hormesis fairly late. In 1958 I was at Oak Ridge -- or he didn't say Oak Ridge -- I was at the lab, and they had potassium without potassium-40, and they were doing cell studies. And the cells looked good but they didn't function. And it was the LNT -- and he made the additional statement -- it was the LNT that kept that work from being published. Now we know that the potassium-40 was removed from potassium through the calutrons at Oak Ridge to do biology experiments through the fifties. There was a 1962 dated bottle of the stuff that was used at Argonne in 1982. And that material was recovered from animals, in fact it was contaminated because it had been recovered from animals because it was so valuable, and Argonne actually got another kilogram or something of it made up, about $75,000 sometime around '80 or '82, and yet you can't find any of the published results of that in the literature. And reports of people who were around the biology community at the time said oh, yes, we did mice experiments with that, and when the material was there, we had seen the detrimental effects on animals. But that work couldn't get published. In fact, you can't find it. You do a search in the literature, you can't find anything about biology experiments. And you look at this in the context of what's going on today and realize that for 40 years this process of basically denying that the data exists is part of our legacy. It became important in the fifties partly because it was the argument against allowing the military to have control of the bomb and some of the argument against above-ground tests in order to pursue the issue of public fear of fallout, and some of it was public fear enough to work against the post-Korean War period of the Atomic Energy Commission and the Army basically trying to say hey, with tactical nuclear weapons we can get into the battlefield, and there was some concern that this thing would get back under the umbrella of the military, especially after a lot of the successful experiences with putting the soldiers in the field with weapons. So part of the campaign was to create public fear about fallout, part of the official government campaign of people I know who were involved in the time, Robley Evans said he was involved at the time. One of the great mistakes we ever made. But now we're stuck with this, and it's, as I said yesterday, whether you think of it in terms of the biology of the LNT and its fraud, or the actual consideration of how much radioactivity you're putting into the environment and whether or not it has an effect, you can't justify spending the hundreds of billions of dollars we're justifying other than to say the public is being misled. And the one last statement I intend to make just on this point is I thought Greta Dicus' comments were quite salient about this significance about what we have to do about protection and why it ought to be cost-effective, but there's an element that keeps coming in in her remarks and subsequently that says well, it's the public demands it. I'm here to tell you as I kind of said yesterday that the public only demands it because they've been made afraid by the kind of promulgation of a misrepresentation of the nature of radiation health effects that this agency as well as EPA and DOE and others are directly accountable for because they promulgate this stuff, and it's the promulgation of an NCRP report in an unexamined way that leads us directly to the point that we're at. There is a lot more on the presentations of others that I would address. I don't know how you are going to run the meeting itself. DR. WYMER: Well, we'll give other people a chance next. MR. MUCKERHEIDE: I appreciate that. DR. HORNBERGER: Could I ask just one question? DR. WYMER: Sure. DR. HORNBERGER: Jim -- I'll try to phrase this carefully. In your view, if we had a completely neutral, unbiased group of scientists look at all the data, would they inevitably come to the conclusion that there is a threshold for an effect? MR. MUCKERHEIDE: It's inevitable. DR. HORNBERGER: And do you have any idea as where that threshold might be in a regulatory sense? MR. MUCKERHEIDE: Ten to 20 rem. DR. WYMER: Thank you. DR. GARRICK: Can we have some more questions? DR. WYMER: Go ahead. DR. YANIV: I would like to make just a brief comment to bring to the attention of the committee a fact that the speaker addressed NRPB, British standard of nuclear workers. Just two weeks ago an expansion of this standard has been published with a much longer follow-up and greater statistical strength. Now I have not read this standard. All I know about it is what I read in the latest issue of Nucleonics reported on this study. I want to make an additional personal comment. The speaker indicated that the threshold might be within about 20 rads of, say, effective dose equivalent. Now this is a level coming up -- about from natural background and medical procedure over lifetime, and let's just assume that he is perfectly correct and that there is no linearity above natural background, et cetera. Now just imagine the regulatory scheme under those circumstances. First of all, we won't be able to discount natural background or medical irradiation because the cell doesn't care, it doesn't know what it comes from, manmade or non-manmade. Secondly -- so once we reach the threshold from whatever source it might be, every milli or microrem is not equal to another microrem and on top of that we do not avoid the linear scheme. I don't think I have to continue to imagine the nightmare, the almost total impossibility to do anything. Basically, I would just say be careful what you wish for, you might get it. [Laughter.] MR. MUCKERHEIDE: Well, I find it -- DR. YANIV: I will underline this is my personal opinion. It is not anyone else's position. MR. MUCKERHEIDE: It strikes me -- two things. Number one, we have many toxic materials that we put in our vitamin pills that we are able to manage quite well. The idea that we become into a nightmare because we give up a straight line doesn't seem to me valid. On the other hand, if you want to have a straight line, have a straight line, but the issue is not to cook the science to help you prove it and not to pretend that it is a scientifically based straight line. Make it a policy-based straight line but don't bias the science in order to justify it. DR. YANIV: The question is who is cooking the science. MR. MUCKERHEIDE: NCRP. DR. YANIV: That is your opinion. MR. ROCKWELL: No, that's a fact. MR. MUCKERHEIDE: That's a fact. MR. HALUS: If we can, there are other people I think that want to have comments and presentations. We have noted a disagreement on that, but let's move the process forward, please. DR. POWERS: I wonder if I could ask the speaker a question. I think you have made some sort of a case that Dr. Upton has acknowledged that maybe you didn't do a real good job in taking into account some fraction of the data, and has made a commitment to do something better. Do you think that is going to change the outcome of the report, which to my mind basically says there is a lot of data out there. It doesn't yet have a consistent interpretation. We need to do more research. MR. MUCKERHEIDE: Do I think it will change it? No. The data has never changed the reports in the past. DR. POWERS: No, no, I'm -- I will concede a certain disinterest on the part of the authors of this and say that having examined the studies very carefully, would it change the conclusion of the report? MR. MUCKERHEIDE: Oh, yes. Oh, yes. DR. POWERS: You think that these studies that were neglected are so persuasive that even in the face of the stringent statistical justifications that you have to have that they would lead to -- there would be no need for any additional research, it would just become obvious? MR. MUCKERHEIDE: It would become obvious. You look at it in one sense and this isn't the only way to approach it, but in Japan in the early '80s up to about '85, '86, '87 they did a series of experiments with mice that if we look at what we are doing today in molecular biology and by the time you get two experiments people are ready to do clinical trials -- well, they did a whole series of experiments and showed the stimulatory effects of radiation at 10 to 15 r that was enough to start clinical trials and the stimulatory effects of radiation in mice was dramatic. They in 1986-87 were treating cancer with stimulatory effects. They got into the same bind that the medical establishment here has gotten into, because they couldn't get public funding for it because, as one of the Japanese research managers said, ICRP was against it and we couldn't get government money to support it so only a little private money was available, but they started a clinical trial on non-Hodgkins lymphoma anyway and found a dramatic improvement in the success rate of treating non-Hodgkins lymphoma patients, even though the only point at which they got to treat the patients was at the point where they were pretty much beyond hope in terms of normal procedures, and if you are going to try to stimulate the immune system ideally you would do it a little earlier but out of that population of patients they saved a number of patients over the five year survival rate and now in the last year or so the 10 year survival rate. To end up, here is Ted Quinn. Welcome, Ted -- and so if you are in a mode where people are actually treating cancer successfully by stimulating immune function then you have got that kind of underlying science, but the issue is whether or not that science is acknowledged and recognized when it comes to the subject of radiation protection, so part of the disconnect here is that a lot of the biological sciences and a lot of the interest in some of this information is not considered in this process. A similar situation of not being able to get at the data exists in the Cobalt-60 contaminated buildings in Taiwan. DR. POWERS: Well, I guess what I am saying is that you have a lot of point studies. Other people have a lot of point studies. There are viewgraph after viewgraph after viewgraph of point studies. There still isn't a model that connects all these results that says ah, yes, I can explain why this guy got this and this other guy got this other thing. MR. MUCKERHEIDE: I don't agree. DR. POWERS: In that kind of an environment, people will say gee, we need more research. I mean it is not the most novel outcome of the study -- and I don't see how additional point models -- point studies change that conclusion. MR. MUCKERHEIDE: But you swing from the fact that I make one example and treat it as though it is just a point. The fact is there is a whole spectrum of studies and part of why we ended up putting some of this documentation together, even though it kind of became just contributions from a number of people, is that there is a wealth of data. In fact, in 1980 the first book on hormesis had 1269 references. It has been going on since the turn-of-the-century. I mean Calabrese referred yesterday to the debate at the early part of the century was whether or not it is a direct stimulation or whether it is a damage response. I mean this isn't new information. There's literally a world of information that just is not considered. DR. POWERS: But what I don't see is one of these plots that has dose across this thing -- the horizontal axis -- and something on the vertical axis with a curve coming in and then some sort of a threshold mark on it and I have got lots and lots of point studies. I just don't have a model that puts everything together. MR. MUCKERHEIDE: Now, wait a minute. We are asking you to do that. The only reason it doesn't exist -- DR. POWERS: You're not asking me, trust me. I am the wrong person to make that plot. MR. MUCKERHEIDE: I will ask the ACRS or the NRC or however you want to look at it, but those of us who have commented on this since the '70s have said the only reason that doesn't exist is because we can spend $100 million to do a Hanford health study, $100 million on Hanford and we can't spend money doing an assessment of the real data. We can clean up Hanford for billions but we don't have that job. That job is with the NCRP. DR. GARRICK: Let me ask a question in connection with that. You make the point of the dangers of doing research and analysis from the point of view of a single cell and chromosome effects without biological interaction. You were here yesterday when we heard about the DOE research program. What is your view about that program in relation to that issue, in the relation to tying the phenomena at the single cell and chromosome level with the biological systems? MR. MUCKERHEIDE: The world of doing that research is very important. It needs to be done. The idea that somehow it is a de novo program I think is false. There is a lot of data. There's the data that hasn't been considered -- in fact, we don't even have computerized Russell's data, spending $100 million over however many years in the early '50s to the '90s, doing the mega-mouse studies at Oak Ridge. That data hasn't been computerized and for about a half a million dollars it can be computerized and there is an enormous amount of data there that is worth recovering, and yet we always seem to treat this as though, hey, there's new work to do, and in fact there isn't even really a substantial pursuing of the issue that Russell's data was cooked in 1951 and that that was stated -- in fact, what was interesting yesterday, one of the points, was well, you know, we are concerned about the genetic effects not of genetic effects so much as genetic related diseases. Well, what is not really said there is that when it was identified that Russell's data in 1951 that talked about a doubling dose of 100 r was not including the cluster of mutations on exposed population it became clear that the actual genetic damage had a doubling dose of between 500 and 600 r, which is virtually a lethal dose, and so that the whole idea that there could have been genetic effects went out the window and so since that came up and those records were sealed in 1995, by the way, and since that came up the whole ICRP process has shifted away from, you know, we don't have genetic effects but we are concerned about genetic diseases -- and we have never identified a genetic disease associated with radiation, but now that is where all their genetics research money is going because we no longer have a genetics problem. But nobody has pointed out that it is because somebody, you know, opened up the files and said, hey, you know, the data stinks. DR. GARRICK: Let me ask another question, a follow-up about research institutions. You have also sort of made the point that there seems to be an institutional commitment to the LNT by those bodies that are normally entrusted with being the experts on radiation effects, such as the NCRP. Maybe you include in that the NRC and maybe you include in that the National Academy of Engineering -- because of the BEIR reports -- MR. MUCKERHEIDE: No -- actually the National Research Council. DR. GARRICK: National Research Council. What is your view, and this question was presented yesterday, of creation of bodies or institutions where you think that there would be a high likelihood that the total database of merit would get reasonable consideration? MR. MUCKERHEIDE: I don't have a conclusion. My one view has been that we have an NCRP and an ICRP and they have tended to have a focus on radiation protection and they are funded by the radiation protection agencies and as a result we really don't have a full consideration of biology, medicine and health sciences, physiology, et cetera, that a lot of the literature that exists is in biological sources that are not generally considered to be part of the radiation protection establishment. One of the comments, for example, well, some of these sources are, you know, publications that are remote. And I look at, for example, last year there was a publication in "Gerontology," in May of '98, in France they took 300 mice controls, all in one room, 300 mice with thorium under the cages, 7 mr per year, 300 mice -- 14r per year -- 14r per year. The two exposed populations lived statistically significantly longer than the control population, which is what we have always seen when you have whole animal exposures. But that data, I didn't even really pick up on it, but that data certainly doesn't get to the radiation protection establishment. But there are dozens, hundreds of studies. I mean this is where the literature exists that is almost excluded. If it is not part of the establishment science mainstream, then they tend to ignore it. And it is easy for anybody from that side of the aisle -- and one of Don Luckey's problems, for example, biochemistry, head of the department in a school of medicine, concerned about nutrition, concerned about antibiotics, developed the understanding of the stimulatory effect of antibiotics in chickens and small animals, and it is used in agriculture. He established the principle of insecticide hormesis because if you -- and we all know that you have got to take your full course of antibiotics because otherwise germs get stronger. I mean all of this is part of the same biological mechanism. But when he published it on radiation, even though he had already done it on heavy metals in toxicology, well, wait a minute, he is not a part of the radiation business, so he is over there. And when he tried to get funding, just like the guys in medicine who tried to get funding at Johns Hopkins or the University of California at San Francisco, there is no funding. If it is radiation, you have to go over there. And Professor Kondo in Japan basically concluded only in China is public health controlling studies of radiation effects. All the other countries of the world, essentially, treat radiation separate from the public health establishment, and so we value these things differently. So my argument conclusion is you need to move it into an arena where the public health establishment, that doesn't have a vested interest in radiation and radiation biology, can apply the normal standards that they apply to whether or not there are effects and what those effects are. MR. HALUS: We have had a good discussion on this particular topic. I believe there are other people who would also like to make comments. Should we provide them an opportunity to do that, or are there further questions that we need to ask at this time? DR. FAIRHURST: I would just like one point of clarification. MR. HALUS: Please. DR. FAIRHURST: I think -- let's say I have got your message anyway. I wasn't here unfortunately, but apparently Dr. Land yesterday gave a statistical assessment and what I heard was sort of the statistical impossibility of extrapolating very low doses with obviously concurrent very, very large populations. And then I heard somebody say, well, you expect you will get a result supporting LNT, more or less, if you use one-sided P values. Is this your position? I mean the position that if you included the data that you have and had a totally independent statistical assessment of that, you would see a threshold? Is that what I am hearing? MR. MUCKERHEIDE: Yes, I think that is correct. MR. HALUS: Are there any further questions from the committee? Is there another presenter that would like to make comments? MR. ROCKWELL: Could I point out that Ted Quinn, the President of the American Nuclear Society, did make it. I don't know when his plane has got to leave, but if he could talk now, I think that would be appreciated. MR. QUINN: I would very much like to speak. DR. GARRICK: Okay. Please. Please take the time now, Ted, to go ahead and address -- if you would, step to the front and put on a microphone. MR. QUINN: Good morning, Mr. Chairman. Good morning, panel. I am pleased to come before you for just a few minutes to represent the American Nuclear Society. I have a number of messages from the American Nuclear Society, and then I have a couple from myself. The first is I thank you for a couple of minutes to have the chance to come before you. I would like to recognize that I believe today you have a very distinguished panel sitting at the table, with the experience and credentials that can address this position. The position of the American Nuclear Society is this is a very serious issue, and I am proud that the ACNW has taken it on the table to address it. It affects the future of our nation, it affects the future of how we perform everything in nuclear science and technology, and I believe you at the table, and with the input from these experts that have provided it, are well qualified to address it. The ANS is developing a public policy statement on the issue of the effects of low level radiation. We are not ready to release it yet, we are still in the works of developing the policy, but I think it has elements in that have a short-term and a long-term nature to it. The long-term nature addresses the importance of molecular studies in science, as has been proposed by the DOE, and is working through. And I believe those studies have great potential in the long-term to address the issues that are so critical to us -- whether there is a threshold, what is the process of cell reconstruction to support the resistance from toxicity, resistance from radiation, resistance from any other cell damage mechanisms? And I am very pleased with that long-term progress and the fact that DOE is funding. We certainly support continued DOE funding to make this work. In the short run, I think this group, and I think our nation has a responsibility to develop limits that are fair and equitable. Now, I would like to step out and say what is my own personal opinion. My own personal opinion is that the limits of 100 millirem are fair. I believe the statement of the Health Physics Society, and I support it myself, is very fair and equitable. And that is all I am prepared to say, Mr. Chairman. DR. GARRICK: Thank you. MR. HALUS: Do we have any questions from the committee? DR. GARRICK: Ted, when do you expect the policy statement to be finished? MR. QUINN: I would say within the next three weeks. DR. GARRICK: Is there anything you can say about? Pardon? DR. FAIRHURST: I was just surprised that it would be available so quickly. MR. QUINN: We have been working on it for over a year, and it is such an important subject, and somewhat controversial, that it takes that long for us. And I apologize that we didn't have it to present to you today. DR. GARRICK: Yes. MR. QUINN: What does it say? The thrust of it, again, it addresses the importance of molecular science. As we go down the road, it is critical to us that the human genome and other issues that are doing so great in the technology of the future have the potential to go in and address a threshold level in a scientific approach for molecular science. That doesn't in a way denigrate or take away from some of the other studies that are occurring, have occurred in the past, to provide you with data from a scientific approach that can give an earlier answer. But I believe in the long run, those studies are critical. DR. POWERS: How did you arrive at 100 millirem was fair and equitable? It just seemed like a good idea or -- MR. QUINN: I believe the current -- and this is, again, what I believe and not what is a position of the American Nuclear Society. DR. POWERS: I understand. How did you come up, arrive at 100, not 200, not 50? MR. QUINN: I am a power plant engineer, and I spend all my time and days in the power plants. I am not a molecular scientist or a health physicist. I would say my belief is based on the people that work for me, or out there in the field that have stated -- or the position of the Health Physics Society and others that have stated that experts believe this is a fair and equitable limit. I can't tell you myself, based on any personal experience, other than that. DR. POWERS: You are in the same position I am. MR. QUINN: Okay, sir. DR. POWERS: Have to believe the experts. MR. QUINN: Yes, sir. DR. POWERS: But the experts have been called into question here. MR. QUINN: Okay. Well, I will reinforce the importance of this particular group. It is an enormously serious question, and I am very proud that your group is taking a straightforward approach and looking at it. It is critical to our future. MR. HALUS: Other questions from the committee? DR. WYMER: We do want to thank you for making the effort to get here. MR. QUINN: Yes, sir. DR. WYMER: Through a difficult traffic situation and probably other problems. MR. QUINN: It is, but the importance is that you are looking at it, not me. The importance is that you are doing this, and there are 250,000 people or more out there in the industry that depend on your deliberations. So I look very much forward to the results of your deliberations and I hope that all the scientists that you need to help support this provide input to you in an appropriate manner. MR. HALUS: Kim and Otto, do either of you have questions? DR. RAABE: I have a question, Ted. The Health Physics Society came out a couple of years ago with the position statement, "Radiation Risk in Perspective." I am sure you are familiar with it. MR. QUINN: yes. DR. RAABE: Basically saying that there is no basis for quantifying risk below an exposure of 5 rem or a lifetime exposure of 10 rem, but that we don't have any mechanism for quantifying it. MR. QUINN: Okay. DR. RAABE: What is the position of the American Nuclear Society with respect to this position statement? Has the Society discussed it in any way, -- MR. QUINN: Yes. DR. RAABE: -- or do you have something to say about it? MR. QUINN: Okay. It provides great input to the development of our public policy statement on the effects of low level radiation, we refer to it in there. The issue is we haven't signed it yet today. So when you ask me what is the position, it is in advance of my ability to say, Dr. Raabe, and the committee, that this is the position of the American Nuclear Society. I spoke to my own experience and not -- DR. RAABE: I guess what I am asking, do you see anything on the horizon that would suggest that the American Nuclear Society would contradict this or go with this? MR. QUINN: No, absolutely not. No. DR. POWERS: What is the position statement supposed to accomplish? MR. QUINN: Good question. You are asking good questions. The issue of the position statement is that today, in the scientific community, there is a tremendous amount of discourse in addressing this particular issue. And I suppose maybe I could personally say the data of that discourse, is I have had experts within the American Nuclear Society working overnight, many nights to address the development of a public policy statement in this issue, and some even present have spent that. And the issue becomes it is significant, it requires, on the behalf of scientific societies, a scientific approach. If I was a representative of a trade association or -- I mean I would take a different position relative. But we believe that the scientific community can provide answers, and that there's two parts to it. From the Wingspread Conference results, I am sure you are all much more familiar with that than I am, there are two responsibilities in our country we saw, that scientists that support this committee and others come up with a scientific solution, and that the public policy arena address the issue of setting up appropriate standards, and that the public is made aware of those appropriate standards. All of those issues are addressed in our public policy statement, sir. MR. HALUS: Any further questions? [No response.] MR. HALUS: Thank you for your comments. MR. QUINN: I would like to thank you again, Mr. Chairman, and the committee for this time. DR. GARRICK: Thank you. MR. MUCKERHEIDE: Can I just make a comments about Ted's -- and stay there, Ted, so you can adjust this if I misspeak at all. Having worked from the perspective of the Chairman of the Low Level Radiation Health Effects Subcommittee at the ANS, my sense of where we were driving over the last four or five years is that we are not -- we, the ANS, speaking now, are not the experts, and signing on to the Health Physics Society statement was not something that the ANS, through its own Society, its own wisdom, if you will, as the engineering and technology people, could or should really do. Our issue is the debate is strenuous, it tends to not get recognized very much, and it must be addressed by our institutions. And I think, you know, reading into all of that, you have got to accept that, in one sense, the ANS can't make a scientific decision on this because it is really up to the Health Physics Society, the Radiation Research Society and others where that debate goes on. On the other hand, the emphasis we have had is we can't let the institutions continue to set it aside it or ignore it. We have to urge that it be undertaken in a serious scientific vein and not just as a matter of policy. MR. HALUS: Thank you for your comment. Are there other presentations that people would like to make from the floor? I guess we have another one coming up now. DR. POLLYCOVE: Well, again I appreciate the opportunity to make essentially a couple of comments about the future and what should be done. First I would like to address the question of the molecular biology and the models and so forth. I think that this is very important because I believe that much of the resistance to departing from LNT is stated very, very explicitly in the NCRP Report 121. They have a biophysical presumption. They know that the damage done to DNA is proportional to the radiation it receives, whether it's low LET or high LET. They know that that damage isn't all repaired, and therefore proceed to the conclusion that there must be an incremental risk for all amounts of radiation. Again, they state it in a very succinct and truthful manner, and I don't disagree with any of the statements that I made so far. That's all true. And Ted read this yesterday. So that any of these effects as due to radiation of cancer, suppressor genes and oncogenes being expressed and so forth, any of these effects could result from the passage of a single charged particle causing damage to DNA, and we know that damage is proportional, that could be expressed as a mutation or small deletion. It's the result of this type of reasoning that a linear nonthreshold response relationship cannot be excluded. When you have that firmly in the back of your mind, you're going to view all evidence that supports this view as being scientifically correct and all evidence that contradicts this as being some hidden flaw in it, there's something wrong, because this is -- how can this be right and how can that be right at the same time? Now, it is this presumption -- and I use the word "presumption" correctly -- it is this presumption that as a result of this type of reasoning, that a linear nonthreshold dose-response relationship cannot be excluded, it is this presumption based on biophysical concepts -- and again, it's absolutely true -- it's based on biophysical concepts, not biological concepts, not on an intact organism responding with homeostatic principles. This is -- I could not -- this is absolutely correct. It is this presumption based on biophysical concepts which provides a basis for the use of collective dose in radiation protection activities. Now how can you justify any more strongly the necessity for molecular biological models based on biology to explore this and find out indeed if linear damage to DNA is translated into a linear risk to the organism. This is exactly this question that is so valuable to the DOE effort now. Now that doesn't mean that one should then exclude epidemiologic evidence that contradicts LNT. There's been a great chorus of support. We don't want any more of epidemiologic studies like Cohen. We don't know what's wrong with it, but it must be wrong. We don't know what's wrong with the nuclear shipyard worker, but there must be some mismatch in the controls, et cetera, et cetera, et cetera. Well, I think that if a model, a biological model that can explain how at the same time you can have damage that's proportional to radiation, and you see, even if you repair the damage in a constant way, and that's admitted, let's say 99 percent of the damage is repaired or 10 to the minus 6 is all that's left over, only one part in a million remains, still this concept is absolutely correct. If you have a constant repair of the damage, then LNT follows as night the day. So we have to go to the molecular biology, and it's for this reason that I began about a year and a half ago to work on a biological model. And it was for this reason that we pulled together international experts in a meeting in Berkeley to which Marv Frazier referred in June of last year to discuss this whole topic, including endogenous damage. There's no endogenous damage, and it's not affected in any way except in a constant manner by the -- still it's LNT. So the endogenous damage has to be taken into account, and these adaptive responses have to be taken into account, and show the great high probability that these mechanisms of prevention, repair, and removal operate on the endogenous damage as well as the radiation damage. And from an evolutionary standpoint this makes sense. At any rate, so on this basis that the model was developed that Marv Frazier felt was if all the experts can agree, and these include experts on radiation damage, if all the experts on damage and repair and so forth can agree on the model, then this furnishes a basis for targeted research to see if some of the assumptions in the model based on what we know now indeed are valid or whether they need to be modified and so forth. So this is really why I think this molecular biological research is so important, because we have to see whether this biophysical presumption actually materializes as a correct biological function. Okay. Now there are many points in the NRC report that I think demonstrate -- how shall I put it? -- the lack of impartial treatment of both sides of the issue. And to focus on one only, with the time that's available, I would like to just focus on Bernie Cohen's work, because Evan Douple referred to that that the BEIR VI committee gave it great attention, spent a great deal of time, in fact there was even a BEIR VI workshop that we had for two days in preparation for dealing with Bernie's data. So it did get a great deal of attention, and was dealt with specifically in the BEIR VI report. It was also dealt with specifically in the NCRP report which came out about a year later after the BEIR VI report. Now from the -- and I'll distribute this letter -- from the Central Laboratory for Radiologic Protection, the director, Dr. Stavomir Sterlinsky, wrote this letter to Dr. Meinhold, and he thinks that this report is very important and certainly deserves an in-depth reviewing. However, we received it relatively late and time limits restrict us to only a few comments. And I will only excerpt the comments that he makes, and then show the data which was shown in the BEIR VI report which Evan Douple put on the screen yesterday and contrast that data which was shown as a justification for discarding Bernie Cohen's data with Bernie Cohen's own data in his own report, which they refer to. All right. Now, general comments. Papers quoting as supporting LNT often contain data to the contrary, and evidence against LNT is often downplayed. Ecological studies and epidemiology cannot be regarded as trustworthy and should not be relied upon to study low-dose effects -- page 156. If they provide evidence against LNT, e.g., Cohen, 1995, yet they are acceptable otherwise -- and specifically Dimidchik et al., 1996, on page 180. Page 154 to 156, ecological studies, this is an exceptionally biased discussion -- now maybe biased is a harsh word, Otto, but he uses it anyway -- [Laughter.] In which the arguments of only one side are presented. Cohen, 1995 study demonstrates LNT predictions of lung cancer mortality due to residential radon -- and this is all Bernie claimed -- is not confirmed by epidemiology. He says I'm not trying to prove hormesis or anything else, I'm just saying that the predictions that are made by the mine workers study and EPA are not confirmed when you actually go out in the field and see what goes on. Now, so, in this chapter five papers are cited in support of statements that ecological studies such as performed by Cohen are intrinsically biased. Cohen refuted most of these arguments in his publications, none of which were even mentioned here. In other words, they don't cite the Cohen responses to these criticisms. A striking example of the biased treatment of this subject is at the paper of Lubin, 1998, in which Cohen's work is criticized, is cited here twice. However, the arguments from Cohen's reply in the same issue of Health Physics, pages 18 to 23, and information that the so-called Lubin's effect contributes very little to the huge discrepancy between Cohen's data and LNT predictions, and offers no plausible explanation of this discrepancy, are not presented. A similar biased treatment of the available information is continued on page 197, lines 1, 2, 3, 4, 15, 17, 18. On page 158 -- sorry, that has to do with the atom bombs in Japan. Let's continue with the Cohen. Here we are. MR. MUCKERHEIDE: Page 197. DR. POLLYCOVE: On page 189 again this has to do with lung cancer and cigarettes and downplaying. All right, here we go. Page 193-197. This is a continuation of an attack on Cohen. Study demonstrating that residential radon cannot practically be a causal factor for any lung cancers in the United States. In this attempt to disqualify the methodically meticulous work of Cohen four papers are cited here. Cohen responded to this criticism, refuting most of the arguments against his work, and he cites the Cohen and Colditz, '94, Health Physics '64-'65, your reference Cohen '95, Cohen '97, Cohen '98, Health Physics 7518, Cohen, ibid, page 23, Cohen '97, Health Physics -- none of these Cohen papers are even mentioned. A statement on page 197, line 28, the results of Cohen's study cannot be relied upon should perhaps end with "because it does not support LNT." [Laughter.] This is another example of a biased approach to NCRP SE 16 report. Now let's look at the slide that Evan Douple -- here we are -- in the front, here we go, good -- showed yesterday. MR. HALUS: We have about five minutes remaining. DR. POLLYCOVE: Okay. This will be very quick. I want to point out that the bars are shown on the cohort studies. The cohort study shown -- the average in a solid line, the mean of about 9 cohort studies, that solid line. You can see the points and you can see the bars on it. And then below it we have this sort of figment of the imagination, misplotted, the points should go through those lines, so it looks steeper and more ridiculous than it really is, and no bars, no bars at all. Now -- oh, thank you. So anyone looking at this would say well, you know, here's solid data with statistics and here is a fantasy. Well, what actually does this curve look like? You see how small the bars are. They're very tight. These don't begin to approach no effect, let alone theory. Now perhaps they were annoyed by the fact that the theory is shown in the dotted line. [Laughter.] But there are no points up there. There are no bars up there. So they said well, we'll do the same thing to Bernie. But Bernie has very tight, very tight. It's very interesting to note that from four picocuries per liter on how big the bars get. Of course, the reason for that, there relatively few homes that have that high radon concentration. And that explains exactly why EPA set this -- there's no scientific basis for setting the remedial level at four picocuries per liter. No, you set it where you're going to get the least public resistance. No science. DR. RAABE: Myron? DR. POLLYCOVE: Yes. DR. RAABE: Can I say something about this. DR. POLLYCOVE: Sure. DR. RAABE: While you have it up here? Myron and I participated in the hearing for the NCRP committee meeting, and we were both present when Bernie Cohen presented this to the committee, and Jay Lubin got up and criticized it. And what it really came down to, Jay Lubin, who is really the author of this BEIR VI model, he gave a very, very strong condemnation of the whole methodology from a mathematical basis. It appeared to be quite a rigorous mathematical derivation, with lots of equations on the board. That went through because this being an ecological study, Bernie Cohen did not know the dose to anybody. All he knows is the average concentration in homes in these counties, so no particular person's exposure is known. Okay, so this is what you call an ecological study for that reason. Now what Lupin did, he convinced the committee from a mathematical argument that if there were a presumed unknown cross-level confounder, mathematically the slope of this line could be anything, and the committee accepted that. DR. POLLYCOVE: I know. DR. RAABE: That's what it comes down to. You were there. DR. POLLYCOVE: Yes, I was there. DR. RAABE: It was a devastating presentation. He took 30 minutes to condemn this methodology -- DR. POLLYCOVE: But it was on a theoretical basis and Cohen's response to that and show that even if that were true and the smoking were completely inversely related to the radon concentration -- in other words, you had more radon, the less smoking -- it still wouldn't bring it up to the horizontal. DR. RAABE: The point I wanted to make though is that the committee heard both sides and they made a decision to accept Lubin's argument. Now I don't personally accept it but I don't see the committee as having some sort of sinister type of reason for rejecting it. They accepted the Lubin argument and it was a very strong, well-presented argument so when the committee sat down to go over it, the way I look at it, they said, well, if Lubin is right, then Cohen's slope is meaningless, because that's what Lubin said. DR. POLLYCOVE: Then what is the point of not plotting Bernie Cohen's curve correctly and dropping the bars and all of that? That has nothing to do with theory. That has to do with scientific integrity. That is my point. It's not a linear model. DR. HORNBERGER: Put that back up there. That's an exponential model? DR. POLLYCOVE: No -- DR. HORNBERGER: Plotted on semilog. DR. POLLYCOVE: This is plotted on semilog, right. DR. HORNBERGER: That's an exponential model. DR. POLLYCOVE: Right, right. DR. HORNBERGER: It's not linear -- it's not a linear no threshold model. DR. POLLYCOVE: No, that's right. DR. HORNBERGER: Just a point of clarification when you have that up there. DR. POLLYCOVE: Oh, sure. DR. HORNBERGER: I think I know the answer but -- DR. POLLYCOVE: Right. DR. HORNBERGER: Are the indoor studies and the miner studies -- I assume that they are also corrected for smoking? DR. POLLYCOVE: Yes, presumably, although you see, the smoking of the miners I don't know how that was objectively determined. In fact, I don't even know how the exposure of the miners was objectively determined. Many of these miners were people who worked 16 hours shifts, although they only considered 8-hour exposures every day they worked, and some of them slept overnight in corners which had enormous stasis and collection of radon, so that the dosimetry of the miners study was far worse than the dosimetry on the counties where they actually measured the residential, average residential radon exposure in the homes and assumed they were in so many hours a day, and even the ones where they did individual and the case control studies, there was no telling exactly how many hours each member of the household spent in and out of doors so that the exact dosimetry was very difficult, but it was particularly loose in the miners. DR. HORNBERGER: Yes, well, one of the reasons I asked -- as you know, I am not an expert -- DR. POLLYCOVE: Right. DR. HORNBERGER: -- but I served on a committee with somebody who did some of these miner studies and I recall, I may be recalling incorrectly, but I recall him telling me that it was a very, very strong correlation with smoking, that basically -- DR. POLLYCOVE: Oh, yes. DR. HORNBERGER: -- basically that miners who did not smoke basically were not affected by the radon exposures. DR. POLLYCOVE: That's right. In fact, that was the response of the BEIR VI committee when they were asked, well have you checked the radon in you home? The only one that responded -- everybody stonewalled on it except Roger McClelland, and he said well, no, I didn't check it but I don't smoke so it doesn't make any difference. DR. WYMER: Do we have other questions about the presentation? DR. RAABE: Just one comment on this one. Those so-called datapoints are not actually data. They are the result of a very complicated, maximum likelihood logistic -- as Charles Land described to us yesterday and those are the estimated means and the standard -- and the 95 percent confidence range for those means. The actual data, which I have here, is a scatter plot. DR. POLLYCOVE: Right. DR. RAABE: It's a scatter plot, okay? So this is generated by a computer program with a log linear model and it is anchored at the zero dose point. There is no zero dose point. That was created by the computer. DR. POLLYCOVE: Right. DR. RAABE: Now if I would suggest that that zero dose point which creates the relative risk of one was off by just 10 percent, you can suddenly get a straight line across there that has no dose response relationship at all, so there is a lot of things going on in this -- DR. POLLYCOVE: Right, and even these, every one crosses the no effect line. DR. RAABE: I have to make one more comment and that is I did my doctoral research on radon in the '60s. I think I know something about it. Now these case control studies, yes, they correct for smoking because they match the case control so that they have smokers, but how would the figure out the dose to radon over the lifetime of these people? Now I studied radon, you know, and I know a lot about it I do not think I could estimate my personal lifetime radon dose. Now can they get it by looking at somebody's home where they happen to live at a certain time? It is a very difficult problem, to get these doses, so there is a tremendous uncertainty in the doses and there is the structure of the regression -- so there are real questions. DR. POWERS: You were persuading me that the argument that the slope of the line could be anything is essentially true. I don't think that either study proves anything anyway. DR. POLLYCOVE: Well, this study shows that the predictions of EPA that if you live in a high radon residence that you have more chance of having lung is incorrect, and that is all Bernie Cohen claimed, that they -- with tremendous statistical power he showed that people who live in homes with higher concentration of radon have less risk of cancer when using the same correction for smoking that the BEIR IV and the BEIR VI use and even if you assumed that there was an inverse relationship you still couldn't get this line to be horizontal. That is what he showed. DR. WYMER: Kim, did you have a question you wanted to ask? DR. KEARFOTT: No. DR. POWERS: It strikes me it is of limited predictive value -- that is, I would not reduce my rate of lung cancer by injecting radon into my house. I have to inject in radon plus engage in all of the other activities that might affect my -- DR. POLLYCOVE: Well, all the other activities you can think of -- he has expanded this to 150 socio-economic factors and shown how each of these will change the slope, and none of them got to zero, and they flip-flopped around the average, and when you take 90 percent of the population, these other factors will bend one way or another but statistically the only way you can get this kind of effect, and as I said this was not only seen by Bernie but seen by many others. In fact, let me tell you how objective Bernie was. For the first few years that he was looking into this, he believed that radon produced cancer. He installed a ventilation unit in his home. He got rid of the stuff out of his basement, but by the time the data piled up into the '90s he turned the switch off. [Laughter.] MR. HALUS: Chairman, I believe you had a question. DR. GARRICK: Yes. Before Myron leaves, I want to ask him one overarching question. Given what we have heard the last two days, and assume for the moment that you are the ACNW, what single recommendation do you think would best reflect -- what single recommendation to the Commission would best reflect what we have learned? DR. POLLYCOVE: Well -- DR. GARRICK: If you want to make two, that's okay. DR. POLLYCOVE: Well, first of all, I would say that we learned that -- in my own personal opinion -- we have learned that there are tremendous biases built in because of the focus on radiation damage and the acknowledgement that for all practical purposes -- this is a little slight change -- but for all practical purposes that radiation damage of DNA indeed is proportional to the amount of radiation, period, and because of this firm concept, as stated in their own NCRP publication, they feel that it is illogical even though they don't have any data, they say they have no data to support it and some data contradicting it with high statistical power, it's all admitted in that one summary, nevertheless that this has to be adhered to, and so therefore this report demonstrates this bias. They want to stay with what they understand, with what is clear and logical, and what supports that they highlight and what does not support it it must be flawed, and they tend to -- so it is not an impartial, because there is this strong basis not being impartial. Okay. So what I think is needed is, as was suggested yesterday, is to have an entity, and perhaps the Surgeon-General is not the best but on first blush it would seem that here's somebody that is impartial, that can get a group of scientists that have not been identified. In other words, even though these people are expert, they should not be included because they have demonstrated repeatedly that they are going to cling to this central viewpoint -- people that are more biologically oriented, that have not been associated with the radiological protection. As pointed out, recently it came to my attention that in Japan there's a study that has been going on for over six years. In the first three years they gave tritiated water for a lifetime to mice and showed indeed that there was a great increase in cancer as the dose went up. Then after they did that study, they went to very low doses, by low doses meaning about in the order of 100 mr per day, which is low dose. That is what we get in a year these mice got in a day. They showed that at these very low doses that cumulative, over a lifetime, these mice showed marked decreases in cancer. For instance, all cancers were reduced to 40 percent of the controls and with a P value of .0007. Now that study was not cited in the NCRP report and yet another study, another revision by Jeffrey Howe, the Canadian breath fluoroscopy study, was cited even though it hasn't been published and it was cited as being published in 1998 in the American Journal of Epidemiology, and hasn't been published yet in 1998, so they reach every shred of data that they feel can invalidate the Canadian breast fluoroscopy study. I am just saying that because of clinging to this point of view that you need to get people who have not been familiar and active in this and perhaps selected by somebody that is impartial and scientific from the biologic community and not the radiation protection community. DR. GARRICK: So basically the recommendation would be because of biases in the NRCP report we need another study? DR. POLLYCOVE: Right, right. DR. GARRICK: And it should be biologically based rather than -- DR. POLLYCOVE: That's right. DR. POWERS: I guess I am struggling with what that accomplishes. You would have a bunch of studies over here, and I find your arguments on the biophysical very persuasive -- if I have that mindset then linear follows as night follows day -- and then on the other hand I find persuasive also the arguments that say cells in petri dish don't have the full amino and biological response and so the biological thing could give you a different model and in fact I have been fiddling around -- can I create a model that does something here? Stay tuned. DR. POLLYCOVE: Well, we hope it will be published this year in either the National Academy of Science or Science so we will have something out front. DR. POWERS: But here is the problem I see is that now I've got another study that says now things go not linear. Okay. Do I stop there? DR. POLLYCOVE: No. DR. POWERS: I got to get in another study that doesn't have the prejudice that's there. I have got more and more studies. DR. POLLYCOVE: Well, it's not a prejudice. If you gave tritiated water to mice in varying doses, and you just find out what happens, and you find out that at the high -- they did the high dose studies first and they found out that indeed the cancer increased proportional to the dose and lifespan was shortened proportional to the dose, and when they went to the lower dose tritiated water study for a lifetime, they found that they lived longer and they had less cancer. Now I don't see why that is prejudicial. MR. HALUS: Okay -- do we have further questions from the panel? DR. POWERS: Well, I would still like to understand how having this study helps. I mean it seems to me the far bigger help is to have, yes, a model that doesn't have this biophysical basis on it -- DR. POLLYCOVE: I agree. DR. POWERS: -- and say here are the experiments one can do that would say yes or no. DR. POLLYCOVE: Precisely. That is where I started. DR. POWERS: I think that is a far more valuable recommendation to you than yet another study with a different group of people. DR. POLLYCOVE: It's hard to understand, it is hard to accept things that you don't understand. In fact, your understanding contradicts those results. It is hard to accept that. MR. HALUS: Are there other questions or comments? DR. RAABE: Just one quick comment. I think the committee is starting to get the feeling here that nobody really understands the mechanisms by which radiation produces cancer. If they did, they would get the Nobel Prize, so they're all guessing. We all know DNA is involved but cells are involved, tissue, organ systems, cells talk to each other. Nobody really knows all the pieces and so this is why there is such a disagreement in the scientific community and if someone is concentrating on the biophysical piece, then they will project that and say well, this represents it. Also, the things that are published are not all of equal quality. And I have looked at a lot of papers that supposedly show things, maybe it is a mouse study -- I didn't look at this one, all right -- but I go in there and look, as a researcher who has worked with animals, and I know there are real serious problems in how you set up your controls in these experiments. And I look at these studies, and I have talked to people, and I say, my goodness, they could get any result they wanted by misrepresenting the controls, you know. And one laboratory actually took a bunch of mice that came in and exposed the first batch to the radiation, and then they wanted some controls, so they ordered another batch, and those were the controls. That was actually reported at a national meeting. And they found hormesis, believe it or not. Now, I am not saying that represents all -- I am just saying each study has to be looked at very carefully. And, also, when a scientist looks at these studies and sees an observation that disagrees with his, perhaps his model that he has, based on other work that he has done, he also realizes that there are chance observations that occur in studies that may agree or disagree, and the standard of acceptance is always going to be higher for some unusual results, results you consider to be unusual. If I send up -- some of my papers, I have trouble getting published because some of my results are unusual. But the standard is higher in science. Scientists say, well, you got an unusual result, you have got a bigger task to prove it. You have to do a lot more. And it is not that you are biased or there is some conspiracy against it, it is just that the bar gets higher if you come up with something that is different and doesn't quite fit the model that everyone is working with. MR. HALUS: Are there other questions for the speaker? MR. MUCKERHEIDE: Can I just ask one question? Myron, you pointed out the fact that radiation damage to DNA is linear. DR. POLLYCOVE: Yes. Essentially linear. MR. MUCKERHEIDE: You didn't mention the relationship to the level of background, normal metabolism and whether or not linear would necessarily result in health effects if you are in the large background. Can you just give a little bit on that? DR. POLLYCOVE: Well, I alluded to the fact that if you only consider radiation damage and not the response of the organism to the damage as Ed Calabrese dwelt on yesterday, then it follows inescapably that if damage is translated one to one into life-shortening and cancer, then it is inexplicable that low doses could have the opposite effect. And it just turns out that when you take into account the adaptive -- I am sorry, I am not addressing your question. MR. MUCKERHEIDE: Right. I wanted to put that in the context of normal oxidative metabolism breaks. DR. POLLYCOVE: Okay. Well, yes. Well, I didn't want to go into the model itself. It turns out that when you look at the amount of damage that is caused by radiation at low doses, per day, continuous, to the damage that occurs endogenously from the free radicals that are caused by oxygen metabolism, it turns out there is an enormous discrepancy, so that even when you take into account that there are 2 percent of the damage that is done by low LET radiation is -- performs -- results in double-strand breaks, and that only one in 10 million -- we did a statistical analysis which the radiation damage gurus and these experts agree with, that only one in 10 million of the random damage done by free radicals produces a double-strand break. There are so many that occur each day that it turns out, surprise, that there are more double-strand breaks, far more double-strand breaks per day from endogenous damage than there is from the low level radiation damage, and not in the one in 25 years, and so forth, and so on, which is just some wild guess, I don't know where that came from. But anyway, I think this is what -- but this is all part and parcel of the model that we are working on, nearing a final draft, and I really don't want to talk about that any more than ANS wanted to talk about the policy, President Quinn wanted to speak about the policy of ANS, until all of us authors, or seven of us, sign off on it and submit it for publication. Once we get to that point, I am willing to talk about it. MR. HALUS: Thank you very much for your comments. Thank you very much for your presentations. Let's go ahead and take a break at this time, say, a 15 minute break. DR. WYMER: Yes. And when we come back, then we will go into a discussion of our report based on this meeting and the discussion period is essentially over at this point. MR. ROCKWELL: Can I just make a quick answer to John's very important question about what should you recommend? One, I think that it is important to point out that serious questions have been raised about the basis for many of the conclusions in this NCRP, and those should be responded to because the report is not -- should not be considered accepted and valid until some of these very fundamental questions that have been raised, time and time again, and ignored time and time again, are responded to. That would be the first thing that I think is important. And then, second, whether or not the LNT as a model is repudiated is less important, really, than facing the question of how low down are we going to continue to insist that we are killing people. The idea that we now say we are killing people at 100 millirem, at 10 millirem, at 1 millirem per year, we have got to face up to that practical question, which is the real burden on us right now. And to say we don't know and, therefore, we are going to assume that we kill people, and actually have the Department of Energy send out a report that says they are going to murder 23 people by shipping shielded casts of rad waste around, as long as we are saying those things, I think we are not in realm of science, and we are really just killing this industry. MR. HALUS: Okay. Thank you for the comments. We will take a break at this time. And would you still like to start at half past or 25 till? DR. WYMER: Twenty-five till. MR. HALUS: Okay. We will start 25 till, and that concludes the discussion from the floor. Thank you very much, everyone, for participating. [Recess.] DR. GARRICK: Okay, I guess the meeting should come to order. Ray, I think what we want to do now is have a discussion among the committee members, the consultants, et cetera, on what we have heard and what it means, and see if we can begin to flush out some of the nuggets that might be the basis for us to make some recommendations to the commission. DR. WYMER: That's right. I think we have, both you and I have independently suggested to our consultants that we really want them to do all the work. So I guess we would like to hear, as a starting point, what each of you, in turn, have to say about what might constitute recommendations and input into a report. DR. RAABE: Before we get into that, I wanted to make one sort of observation about what we have heard over the last day-and-a-half. To me, as a radiobiologist, there is a big gap and what we have heard. And there is a big gap in what BEIR VII is trying to do, and there is a big gap in what the NCRP report does, and that gap, I think is crucial. That gap is inadequate treatment of the effects of protracted radiation. In fact, I could even justify recommending that we should have a report where the committee is asked only to look at protracted radiation instead of -- DR. WYMER: Protracted low level or just -- DR. RAABE: Protracted, it doesn't make much difference whether it is low, you have to put the high level -- as a scientist, you have to put the high level in with the low level to see what the shape of the dose response curve looks like. But protracted radiation, for example, -- it is really what we are talking about within the nuclear waste issue, really, internally deposited radionuclides. You heard in the BEIR VII presentation yesterday, they said, no, we are not going to cover internally deposited radionuclides. So that means they are going to emphasize the acute high dose rate, atomic bomb survivor studies and other related medical data, and very little -- they won't touch on what probably is the most important issue. Also, they work with a very simplistic model to take all these analyses they do of acute high level radiation and try to predict what is going to happen from protracted radiation, and the model can be shown easily to be wrong, by looking at actual data on humans and animals with protracted irradiation. So I just see that as a gigantic gap, you know, we just didn't get it. Some people touched on it a little bit, but only a little bit. And the whole basis of protecting the public with regard to radioactive waste is probably low doses of radiation protracted in time. And if there is a significant difference in the shape of the dose response curve, then we should know that. Now, I actually have worked for about 20 years in analyzing protracted radiation studies from internally deposited radionuclide, looking at about 12 radionuclides, and both high LET and low LET, and I can tell you that from my studies, I always found a very pronounced effective threshold. Very pronounced. Now, that is just, you know, that is my observation of data. But I think the whole point is, if there is a true difference in response, and there is an effective threshold associated with protracted irradiation, we need to pull together the information about protracted irradiation. DR. WYMER: Okay. DR. RAABE: The other one little point, just a technical point that came up a couple of times, and I mentioned it at the very beginning yesterday, and some people asked, well, what did I mean by this? Linear no-threshold has two parts. It has the linear part and the no-threshold part. Now, to some people, when you say there is a threshold model, they think, oh, that means there must be some dose at which the risk is zero. Well, we can prove there is no zero risk because, you know, as Art said yesterday, there are some DNA changes that aren't repaired. When I talk about a threshold model, I call it an effective threshold model, I just talk about the risk going down to very low levels. And when I calculate a risk of 10 to the minus 20, at some low does, for all practical purposes, I ignore that. It is probably the chance the ceiling will fall in this building because some engineer miscalculated some stress on some beam. MS. THOMAS: Don't say that. MR. LARSON: That's 10 to the minus 4. [Laughter.] DR. RAABE: So, you know, to some people, when you say threshold, they say -- it clicks in their mind, zero, zero risk. Well, I don't know if we can -- we can't find zero risk, and I am not sure we need to. DR. GARRICK: I like to call that the speed limit mentality. DR. RAABE: And so the other thing -- and if you read -- I read the whole NCRP report and this is a very important part of the first several sections, that they come to the conclusion that since there are DNA changes that are not repaired, that, obviously, you cannot have a threshold. Now, the linear part is interesting, too, because they also say, therefore, the linear is the best model. Well, why linear, you know? Curvilinear responses are very common in biological studies. And, so, could it be curvilinear with no-threshold? So those are all questions that just popped in my mind as things were going on yesterday. DR. KEARFOTT: I could give a summary of my impressions if you want it. MR. HALUS: That would be great. DR. KEARFOTT: We have time. I just want to start out by saying I am not a toxicologist, I am not an epidemiologist, I am not a biologist, I am not in risk analysis, but I feel like a voyeur about to become a target in an interdisciplinary scientific spitting match. I shouldn't have said that publicly, but I am prepared to get wet, so my comments are only from someone in a closely-allied area looking at what I have heard in the last day. I view there as being three problems associated with this whole issue, credibility, certainty and creativity. Credibility, we have a two-pronged problem. The first part of that problem is acceptance by the public. The second part is acceptance by the scientific community. Certainty, we need to know what is really possible to answer and how well can we answer it. We need to be realistic about what we can know, what is needed to change things, and the need to proceed in the public interest needs to inform our interpretation of certainty. The third issue, creativity, I am struck by a lack of new approaches. The approaches appear to be the same old types of research, although I was given some hope with the humane genome project. There seems to also be some dissonance among the results that is based upon disciplinary lines. I would like to see somebody, and it is probably not NRC, but someone with timeframes for action, to try to look at radical advances, the Manhattan Project, broad and forward thinking individuals who would be unrestrained and unfettered in looking at what are the fields and technologies, et cetera, and DOE has started to do that, that can inform this better. That is probably beyond what this particular committee can do. I want to make some brief comments about what I viewed as each of the research areas and then make some recommendations to you about that. First, is the epidemiology, and I am going to also lump in there, and I will get wet doing this, both the human, animal epidemiology, and the non-human animal research, which I realize is much more controlled. It seems that that is where the human endpoints reside. The results of epidemiologists' studies will also help us with workers in accidents, but may not be that helpful because of the dose ranges that are practical in looking at public stuff, these two types of research are very useful for testing low dose models. The work on this data will help us, give us a better launch point or extrapolation point, the lowest point at which we have data about endpoints, and it will help us understand the confounding factors that may be involved in the inductions of cancer and other effects. We might need new studies along these lines, but we have to be very careful about what type of studies are done. I also get the sense, and I will address this with one of my recommendations, is that there is not really a reanalysis of older data and good quality control of datasets when trying to combine them to make a result. The cellular biological research is the second category of research. I think these are important in giving us the models to go below where the animal and non-human -- the human and non-human animal research takes us. It will help us understand the possibility, the validity, et cetera, of hormesis and is the basis of all our models. We have to be very careful with the cellular research, though, that we don't confuse damage and significant response. I think with these areas of the human epidemiology, the nonhuman animal research and cellular there are other issues that affect those that are holding them back, for example, the way that we're analyzing things. Secondly, different things like what dose quantity is being used and is it appropriate for the type of study. And I have some basic questions about that. I also hear things like well, the absolute doses measured will not really affect the results, they just shift the curve. Well, if you have a nonlinear curve, having an error in your jumping-off point will have a very serious effect on the results. For example, if you had an exponential model, then where you're setting the doses and what quantities you're using for doses are going to completely confound things. The third broad area is about regulatory research, how do you regulate and perform operations in the presence of uncertainty? I think the risk-informed approach is something that there's probably research, it's not scientific, but policy-related research on regulatory mechanisms. That might be something that NRC staff should be encouraged to absolutely continue. The fourth area would be in risk communication and how we do things, and in fact it informs how we treat the results of the other research, and that's both to the scientific community and to the nonscientific community. How do we get acceptance, how do we put through a change and get that accepted? And how do we get scientific consensus among fields? Certainly risk communication and how to run meetings and making sure there's open and how we do this is beyond my expertise, but I identify that as an area of research. The last area is something that struck me in all of this, and this has to do with the synthetic methods of analysis by which we integrate data from different disciplines in order to get a result. And I'm going to speak to that a lot. I do not believe that we have necessarily institutional bias by NCRP, NAS, or NRC. There is something more subtle going on that's affecting the acceptance of this work, and I will address that. Areas of this sort of synthetic methods analysis include items like interdisciplinary peer review of what's happening and are there -- what are the limits of science itself and to how we're reviewing things. Secondly, how you link disciplines together to inform policy. And the third thing which we actually were hearing a lot of this veiled today, the third thing is how to analyze and build models with data from different disciplines. So that's probably the area that should receive the greatest effort at this point if you want to do a fast result. I have several recommendations that fall out of that perspective. Some are -- they're on different levels. Some appear trivial and some appear sort of more broad sweeping. First of all, before hearing Otto's comments, I was struck that not only were a lot of the data that were flashed before us very quickly -- not only were the dose ranges not going anywhere close to what we're interested in, subcentigray, and -- or wherever you want to pick it -- that they were not the right type of data. These are all external exposures, except for the radon base, and I'll privately discuss my opinions on that with anyone who will give me ten minutes. They are primarily external exposures. They exclude for the most part not only sort of protracted or low-dose-rate things, so we have no low dose, we have very little low dose rate protracted exposure information, but we're also missing high LET data. And those are exactly the effects and things of concern when we're talking about decommissioning, decontamination, low levels in the environment. We're talking about internally deposited radionuclides. When you open that, there are things that aren't even being looked at, like dose distributions within organs. I've done a bit of work in nuclear medicine, internal dosimetry, and they found out that if you take an organ and you divide it into the different cell types, in vivo, that you assign dose quantities that relate to those cell types, and you use dose distributions on that to recalculate things, you get a much better correlation between dose and effect. And I think they're just starting to do that in nuclear medicine and radionuclide-based radiotherapies, which are right out at the front of the map in those two disciplines. So there's a lack of internal data, which are the most important, and if anything, you would serve the scientific enterprise by supporting strongly, even though NRC may not do or fund this, but supporting strongly research in that area. Secondly, we need to continue the biological research support, DOE's program, and allow high-risk innovative research. Along that line, because of the policy implications of that research, it is imperative that NRC be engaged, even as an observer, in the interagency reviews of research in these areas. The policy issues, as we heard, are quiet strong. The industrial issues, as we heard from President Quinn of ANS, are quite strong. So in research being conducted and things going on with NAS, DOE, NASA, DOD, NCI, et cetera, in particular the new DOE program, NRC should at the very least have active observers following what's going on so that NRC can stay in touch with changes, advances, while they pursue concurrently what they need to do in terms of other issues. I'm just going to put in a plug for this, as we cannot ignore the need for research aimed at cost reduction in measurements and remediation activities despite trying to look at our limit, I think cost reduction is something that will actually help the industry. My last point is probably the most controversial, and it sort of has two parts. I don't believe in a conspiracy theory, but in hearing how BEIR and NCRP are working, and we've heard their consensus process, I think these are very noble efforts to do a proper consensus process, but you think about it, you have 16 experts on a BEIR report, and there will be one person who actually is the person who is figuring out how to tie together all the data and derive the result. This might be a mathematician or statistician or someone. The same thing with NCRP. You have 60 council members. There are not very many of these data-synthesizing people involved who are council members of the NCRP. When the BEIR and NCRP reports go out to comment, they go out to the stakeholders. They go out to the specialists in radiation protection, they go out to the radiation biology specialists who may favor, just by virtue of being scientists, they're going to favor theories that support their own work. And it's not going to go out to mathematicians, the statistical society, to the people who are scattered across disciplines who are actually bringing together the work. So I would favor something that said there needed to be independent research in the synthesis of this data and analysis by which these models get derived. And I would further wildly speculate that there have only been a handful of individuals involved historically with that in the past. Which I then sort of as a slightly more wild recommendation would say the following which actually supports (e), which is that we need to have because of the historical mistrust by both the public and the scientists, and this is a large undertaking I recognize, some independent new group or groups that will start doing two things. I mean, one thing, you could totally revise the NAS and the NCRP process. That's one approach. The other is to try to find a new group or groups that will do two things. No. 1, they will rereview and attempt to synthesize the existing data, making sure there's peer review of the experts who are doing the synthesis. These are people from math, statistics, et cetera, who happen to have specialized in radiation. But they're not getting peer review necessarily by people outside the radiation field in the synthesis. And, secondly, there might be something to be gained by taking all the data that we have, doing quality assurance or quality control in reanalyzing it. When you do that, you have to be very careful you don't miss 75 percent of the data, and, secondly, that there's an independent judgment, interdisciplinary independent judgment of the quality of the research. No matter how nice your data bases are, if you don't do that, you're not going to get results that are totally credible. So I think I've said more than I should have, and that summarizes my impression of this meeting. DR. GARRICK: Thank you. Otto? DR. RAABE: Okay, back to me. Well, I don't have quite as elaborate a presentation prepared, but I made the point about protracted radiation, which is something that's very near to what I'm thinking about, and I wanted to just point out a few things that we do know really well about protracted irradiation. For example, a lot of people in this century have been exposed to radium-226, and this has been under study for a long time. This book "Radium and Humans" written by Bob Rowland out of Argonne Laboratory summarizes all the data, the effects data and the dosimetry data, on some 2,000 people, 1,450 of them who were exposed to radium-226, very high levels, mostly earlier in the century. Radium was -- I think Marie Curie got the Nobel Prize for separating radium in 1905 from uranium, and after that it was used for all kinds of things, medical potions, put in drinking water, and for luminous dials. And by 1909, just four years after she got the Nobel Prize, you could buy a watch with a luminous dial or a clock with a luminous dial with radium. And the workers who worked with that material got exposed at high levels. But also chemists got exposed, and it was used in medicine. Well, the studies of these people have gone on for at least 50 years. Robley Evans was a big investigator in this at MIT, and then it was taken over by Argonne. What do these data tell us about high LET irradiation of the skeleton from radium? That's the question that we have human data. Well, Robley Evans in 1972 went around the country and pointed out in lectures he was giving, he was president-elect of the Health Physics Society at the time, he went around and said hey, there's a practical threshold. The reason I know this is because no person whose dose to the skeleton was less than 1,000 rad, which is 20,000 rem after you correct for the quality factor for alpha particle, developed bone cancer or had any other effects that we could observe. That was 1972. Okay. Now we have Rowland's report just a few years ago summarizing the final data -- that it will get. There were a lot of people still alive in their eighties and nineties in good health that didn't get into the final report when the study ended. What is Rowland's conclusion? No person whose dose to the skeleton was less than 10 gray, 200 sievert, 20,000 rem, developed bone cancer. We're talking about a gigantic dose. Is this a fluke, or is this real? Okay. So you look at animal studies with radium. Well, it's easy to show why this occurs with protracted exposure. It occurs because when exposure is protraced over a lifetime, there isn't a linear response, nothing happens for most of the person's lifetime, and there's a long induction period until you actually have the bone cancers develop. As the dose rate goes down, which is the concentration of radium in the skeleton, and you have to remember that when people were exposed to radium they had it in their skeleton for their lifetimes, yes, it was cleared over time, and it was reduced, and it went down as a power function with time. So that when they were very old, they had very little left. But they got irradiated almost over their whole lifetime after initial exposure. And so this means that when you look at the data from the human studies and the animal studies, they turn out to agree. And I published this in 1980 in "Science." They agree very well, and also the mouse studies. What they show is that as the average concentration of radium in the skeleton gets smaller, called the dose rate, if you will, the time required to develop cancer gets longer and longer and longer. Now it turns out it takes less total dose to produce the cancer at low dose rates. This is what always confuses people. They say well, you know, lower dose rates are more dangerous. They look at this. You heard this yesterday. It's absolutely true. It takes one-tenth as much total dose to reach a point where there's cancer in people and the dose rate is lower. But the time keeps getting longer and longer. Eventually a finite population of people die of age related illnesses. They die of old age or something else. When the time required to produce the cancer exceeds the lifespan, you get no cancers. We are talking about competing risks. Now if medical science were to extend the life expectancy of people we would probably have to lower some of our radiation standards, because what we are talking about to my way of thinking for these protracted exposures is that in our normal lifespan we don't live long enough for some of these low doses to have any effect, and that is exactly what we see in these people and it is exactly what we see in the animal studies. They agree exactly and also the distribution of the cases of bone cancer from radium is not a broad distribution. It is very narrow. In fact, in the biological system a coefficient of variation of only 20 percent is kind of a minor miracle, and that is what it is for the animal studies. It is about 30 percent for the people. When you plot this up, the average radium in the skeleton versus the time to development of cancer the coefficient of variation is only about 20 to 30 percent. It is really tight, and all it shows is that as dose rate goes down people have to wait longer to get the cancer, even though the radiation is more effective on a total dose basis, but you end up with this lifespan effective threshold. But it is real so you look at these people below 10 gray, 200 sieverts, 20,000 rem, over their lifespan -- they don't develop bone cancer, they don't have any other effects that we can see, and the same is true in the beagle studies and the same is true with plutonium and the same is true with Strontium-90 is a low LET radiation. We studied that at my laboratory and -- non-linear. It is a threshold type response again. When I say it is a threshold type response, I don't mean that there's some dose here below which the risk is zero. I don't mean that at all. Okay, so what we are dealing with then is perhaps this range. Now when I started in this field in the '50s and I went to graduate school at the University of Rochester, they said oh, we are going to use this linear model for radiation protection. Now we know that it is probably wrong but it probably overestimates the risk, so if we are just going to worry about radiation protection and we want to set up some standards, we'll use this linear model. I think the problem came in the '70s when the ICRP started writing things into some of the reports that suggested that they believed they could really count bodies with these models, so you use this linear model. Now what if we had a standard of 100 millirem per year for the public and people actually got exposed to an extra 100 millirem per year for their whole lifespan -- 70 years? The linear model would predict an increase in lifetime cancer of about .3 percent -- .3 percent. On the other hand, if you look at this type of result from these data with several radionuclides, every one I have looked at comes out this way. It is not a fluke. It doesn't make a difference which laboratory or which radionuclide. They all turn out this way. If this is more representative of those protracted exposures, then the risk is considerably less than .3 percent, so the uncertainty we have is somewhere in that range. It is probably lower than .3 percent. It could be so small that it's almost meaningless -- certainly not measurable. Now from the point of view of the statistician such as Charles Land, whom we heard yesterday, if you just go out -- even when Charlie talked -- Meinhold -- if you just go out and say, you know, you can't find that, you're right. You cannot just de novo go out there and try to find a .3 percent increase in cancer rates in the general population where 30 percent of people are developing cancer. You just can't find it, so there is no statistical test and no study you are going to do that makes any sense that will ever find that if it is .3 or to be able to provide that it is not .3 but .1 or .01 or .001 or 10 to the minus 20. There is no way that you can do that directly. So what we are stuck with then is that we have got to look at what we do know, which is mostly high doses and see if we can figure out what the processes are involved. Now why does this occur? Well, to my knowledge nobody has figured out how to tie together the acute exposures which are much more effective at causing cancer with the protracted exposures, because we know that at one sievert we can increase in an obvious way the cancer rate in people from the atomic bomb survivor data. These studies with Strontium-90 or radium, we cannot see anything at 1000 rem if it was spread out over the whole lifetime, but we know if we give them instantaneous exposure to 100 rem there will be a 60 percent increase in all kinds of cancers so there is a big difference, and one of the problems is the model that is -- the paradigm model that is in the minds of the people we heard who are promoting the basic linear model. The paradigm is oh, well, you know, the protraction lowers the slope. You just need a correction factor. It is still linear but we are going to lower the slope -- but it doesn't look like it is linear anymore. So in other words, we don't understand the mechanism that gets us from radiation exposure to cancer. If we can't explain these data as well as the atomic bomb survivor data. If we understood the mechanism we could explain both sets of data -- so there is a big hole in our understanding. As long as there is that hole in our understanding there will be disagreement among scientists on this issue. I am not sure how we can get away from that. DR. GARRICK: Yes. Reaction to the public if they took that out of context could be very negative. DR. RAABE: Of course. DR. GARRICK: That we don't understand the relationship between radiation exposure and cancer -- DR. RAABE: We don't know the exact mechanism. DR. GARRICK: Yes. DR. RAABE: We know that you get -- you expose at certain levels, you get some increases in cancer. DR. GARRICK: But it seems that the concept of looking at the issue not in terms of a threshold but in terms of a curve, if you wish, that can give us insight on what the likelihood is of getting cancer is a much more logical representation of the science than the debate about a threshold. DR. RAABE: I agree with you. I agree with you. Yes, absolutely. It is curvolinear, you know, and I mean it's easy to show that with human data -- now of course the human data that throws a spanner in the works, as the British would say, is the radon stuff that we heard, because they fit this log linear model which they call a linear model and the people who did that really believe that it is a true model so you have this case where you have protracted exposure. Now personally I believe that there is an effective threshold for the radon stuff too but it hasn't been well demonstrated, and you have these data which are very hard to interpret because of the uncertainties in dose and other factors. DR. GARRICK: It also seems that a lot of progress could be made if we think more in terms of radionuclide specifics about thresholds -- DR. RAABE: Absolutely. Absolutely. DR. GARRICK: Than mixes, and this is kind of appealing, because in the nuclear waste disposal issue we usually end up talking about a very few, very few radionuclides, and in fact you can almost generalize it. You can almost say that for low-level waste because more of it's uranium contaminated than we ever anticipated that the driver for long-term exposure will be uranium. For transuranium waste we have seen that the driver over the compliance period of the repository is principally plutonium. And for the Yucca Mountain waste, we now know that for periods beyond 10,000s of years that the driver is going to be things like neptunium-237, with the early dominance provided by iodine and technetium. So the truth is maybe we're just not taking advantage of the characteristics of the problems that we're having to deal with with respect to getting the most mileage out of what we do know. DR. RAABE: Yes. And there are some holes in what we know about those things, too. Plutonium, for example, I've done a lot of work with plutonium in my career, and I've measured plutonium at the Nevada Test Site in the fifties, and I've done modeling, and I've made particles of plutonium, and I've gone to fuel fabrication plants and studied the plutonium particles that were produced during fabrication processes, studied the solubility of plutonium in different forms, and have worked with and was involved in experiments where we exposed beagles to plutonium particles that we made specifically to find out about effects on the lung. And I've modeled the results of these studies. Unfortunately the studies, they were all funded by the Department of Energy, and at the time when the last beagles were dying, they took away the money, so the final complete analysis -- they got more interested in genome work at that time. So the money got, you know, shifted, because they thought the genome work had a bigger payoff. So the analysis was never totally completely done, and data are still available for that, but I have done these analyses of plutonium, and again you find this threshold phenomenon, for the same reason. So I then estimated by a scaling process that I developed what the human risk would be from inhaling plutonium. So then I said well now I find some human data to try to see if it fits the lung risk from inhaling plutonium. There isn't any. Not in the United States. Because although thousands of people have been exposed to plutonium by inhalation in the nuclear industry in the United States, we've got no documented cases of the lung cancer being produced by anyone exposed below the standards -- or above the standards -- in the United States. Now they tell me the Russians are going to supply the data, and they actually have been, because they weren't being as careful as we were. And so they had people exposed to very high levels. But those data are very complicated, because they didn't get exposed to just plutonium, they got exposed to neutrons and external radiation, gamma rays, and all kinds of things. But they have two papers been published out of Russia on this, and one was published in the Health Physics Journal in December, and it shows that -- it states in this paper that there were no effects -- well, I should point out before I get to that that I estimated that the effective threshold, the place where the risk would drop quite precipitously, was at about one gray to the lung, which is about 2,000 rem. So -- because with the alpha particles from plutonium, but one gray. Well, the paper that was published in the Health Physics Journal from the Russian data. They found that below eight-tenths of a gray they had no effects that they could identify, no lung cancer. But to confuse the issue, another group at the same institute published a paper in Radiation Research where they fit a linear model to it. DR. GARRICK: Yes. DR. RAABE: The same data. Fit a linear model to it and claimed that you could describe it with a linear dose-response model. Well, that's not new in our industry. The reason that it works so well is that when you actually plot up the data -- I've done this many times -- when you actually plot up the data as a function of cumulative dose and look at the shape, what I call the threshold region or the region where the risk gets very low is very tiny, it's right at the origin. It's smack up against it, because all -- it's down there below one gray, and all the effects are 2, 3, 4, 5 -- and so it gets shoved over in the corner, and you've seen that on some of these plots yesterday. DR. GARRICK: Yes. DR. RAABE: And it's just a little squiggle, because it's not caused by the radiation, it's caused by the life-span limitation. See, it's not -- the radiation is causing this straight line to appear that maybe it's a straight line, I don't know in this kind of plot, it looks curvilinear to me, but you can put a straight line through it. The radiation's causing that straight line. But that little squiggle, which is the life-span limitation, is caused by something else. People are dying of old age. Well, you can draw a straight line through it and it looks great. In fact, the year that Evans came around the country and promoted this model, Chuck Mayes and Ray Lloyd took the very same data and they regrouped it, plotted it on a linear scale, and drew a straight line and declared there's a linear dose-response. Same data. DR. GARRICK: It's amazing what you can do with the least squares fit. You can make almost anything. DR. RAABE: And it does look good. It looks very good. You look at it and say hey, yes, that's a straight line. Well, that threshold there, this is a log plot, that threshold is way down here in this little squiggle at the bottom, but it's a very important squiggle if you're only exposing people to a few millirem per year -- or a few hundred millirem per year. DR. KEARFOTT: I just have a question for Otto. It seems to me another source of data, there are the animal data, but another new source of data, a long-term thing, are the Chernobyl data. It sounds though like what you're saying is you're not going to see an effect there anyway. DR. RAABE: Well, as you know, they have been studying, looking for effects from Chernobyl, and the last reports I heard, which were I think a year ago when I was in Vienna, basically said that they haven't found leukemia that was predicted by the linear model from the atomic bomb survivor data, they didn't have any of that leukemia; what they did find was thyroid problems with children. That conflicts with some other data that's around, but, you know, still it doesn't sound unreasonable that high doses of I131 to children could increase their cancer rates, and it's not unreasonable, but I've heard people say that that data is a little bit hard to interpret too because they don't have any good baseline information about the number of nodules in the thyroid and so forth, and suddenly they come in with this team of people looking at all the children, and so forth. But I think that's believable, that the I131 exposures to children did produce this effect. They were high doses, very high doses. But nothing else has come out of it, and certainly leukemia did -- they expected it would appear within ten years, you know, they didn't find it. DR. GARRICK: I wanted to ask a question. We've discussed this several times, and I'm becoming convinced more and more of the problems with it, but one thing that I've never really felt that I could completely resolve in my mind was we have at all our nuclear installations since the late forties been wearing film badges and dosimeters and monitoring ourselves quite carefully and health physics and radiation protection in the various reactors and also the laboratories have been tenacious in seeing to it that we do that, and also supplementing our own measurements with their own measurements in areas where special kinds of work were being conducted. And yet I get the sense that this enormous data base is relatively useless. What seems to be terribly disappointing because it's low dose, most of it, and it's very population oriented, but I guess it's a combination of confounding factors and issues having to do with identifying the individuals and how they died and what have you. Why is that tremendous data base not more valuable in addressing this issue? DR. RAABE: Well, the workers in the United States have been under study at various laboratories, and the Cardis study that was discussed -- DR. GARRICK: Yes. DR. RAABE: Is a very comprehensive, complete study, and, you know, what it showed, we heard some comments this morning about it, what it shows is that when you really look at the workers, you can't disprove the hypothesis that there's no risk, and you can't disprove the hypothesis that the linear no-threshold model is correct, because the uncertainty, even when they have thousands, tens of thousands of workers in this composite study, the uncertainty is great. And you saw the data presented yesterday. There is a couple leukemia cases -- there are two labs that have high leukemia and the others did not. In fact, at Oak Ridge leukemia is lower in the exposed people than -- DR. GARRICK: Well, we may not be able to -- DR. RAABE: You know, so it's -- DR. GARRICK: Yes, but -- DR. RAABE: You can't reach conclusions -- DR. GARRICK: Okay. But you did this, you broke the problem down into a linear problem and a threshold problem. Maybe you can't address the issue of linearity, but can't you say something on the basis of this data base about threshold? I mean, the fact that we can't do anything -- DR. RAABE: No. No. DR. GARRICK: Suggests to me that there's -- DR. RAABE: What this largest study of these data, the Cardis study, has shown, international study, is that you can't say anything about the threshold. You can't disprove the hypothesis that the dose response is linear, and you can't disprove the hypothesis that there was no effect at low dose. You can't disprove either hypothesis. DR. HORNBERGER: Well, it depends on what your null model is. DR. RAABE: Beg your pardon? DR. HORNBERGER: It depends on what your null model is. He is saying if your null model is no effect, then there is a threshold. DR. RAABE: Well, I'm saying that the uncertainty, I mean, you have to compare it to something. So they compare it to people at high dose or low dose. DR. GARRICK: Well, there's an uncertainty because you didn't observe anything. I mean, you didn't see -- DR. RAABE: There's not much happening. That's right. DR. GARRICK: But to me that's -- DR. RAABE: As Keith was saying yesterday, we don't know the risk. DR. GARRICK: What am I missing here? To me that's extremely valuable information. DR. RAABE: It is, but it doesn't -- you can't reject the LNT on that basis, and so you'll always have somebody -- DR. GARRICK: No, but again if I look at it in its component parts, and in this case look at threshold, rather than linearity -- DR. RAABE: We have a fantastic record of radiation safety in this country. It's too bad that we can't tell the public about it. DR. GARRICK: Go ahead. DR. KEARFOTT: This goes back to what I was attempting to articulate and which I think Keith Dinger yesterday was trying to do but were not the right specialist. Isn't there something in risk where you have a study like this that you can say that the study shows that within uncertainty sigma that the risk must be less than x under a certain dose. Isn't there a way you can make a statement like that? DR. GARRICK: Sure. DR. KEARFOTT: And isn't that what should be coming out of this? And why aren't we getting this? DR. GARRICK: That's my perspective. That's -- DR. HORNBERGER: But again, as Land said, what you're going to be able to say with that kind of study is an upper bound, and the upper bound you can't discard the LNT. DR. GARRICK: Exactly right. DR. KEARFOTT: Which is fine. That's fine. Who cares? DR. RAABE: That's why I started off. I said 100 millirem per year, you can calculate from the ICRP model, three-tenths percent increase in cancer over the lifetime if someone's exposed to 100 millirem every year for 70 years. It's probably not that high. It may be effectively zero. We don't know, and we can't prove it. DR. HORNBERGER: Right. But, see, my point is that, you know, statistically, if you start with your null model being that the slope is zero, the data can't refute that. DR. RAABE: That's right. DR. HORNBERGER: I mean, that's just an alternate way to look at it. DR. RAABE: The data cannot refute that. That's right. You cannot disprove that hypothesis, that it's zero. Now, we're not talking at all about -- I'm not talking at all about any beneficial effects. I mean, if there -- we heard about beneficial effects, and if there are beneficial effects that affect carcinogenesis, that will alter the findings. DR. HORNBERGER: Yes, but most of the worker studies show the healthy-worker effect. Certainly the Oak Ridge study showed it. DR. RAABE: I think they all do. DR. HORNBERGER: They all do. DR. RAABE: And yesterday we heard that the atomic bomb survivors showed it. DR. HORNBERGER: Right. DR. RAABE: The healthy survivor effect. I've never gotten an answer to this question, because I heard this rumor, and I presented it as a rumor to Charles Land yesterday, and I don't think he bit on it. DR. GARRICK: I see the jokes now. The bad news is you're going to be bombed tomorrow by an atomic bomb; the good news is if you survive, you'll be healthier. DR. RAABE: Well, -- DR. HORNBERGER: You didn't say that, did you? That's going to look terrible in the official transcript. DR. RAABE: The Japanese kept very, very good records of where people lived, and when they were born, and when they died, they kept extremely good records. And I heard a rumor that there was a control group that consisted of people who did not -- were not present in Japan, or in Nagasaki and Hiroshima at the time of the bombing, and they decided not to use it, the rumor, because the people -- most of the people who were exposed had much lower mortality and lower cancer rates. Now, I have never been able to prove that to myself. I have never found that. And that is why I asked Dr. Land, and he didn't say anything against it. He did say there was 26,000 people that were taken out of the study because they didn't like the way they looked. You know, as a scientist, I worry about these things. I don't like censoring the data because you don't like the way it looks. DR. GARRICK: One of the things I -- oh, excuse me. Go ahead. DR. KEARFOTT: Oh, no, it's off. It's a slightly different topic. DR. GARRICK: One of the things that, and this is maybe a slightly different topic, too, but you reminded me of it, that I wanted to raise yesterday, is that I recall, in the last two or three meetings we have had on this issue, that one of the arguments given against some of this data that we are hearing hasn't been adequately considered, one of the arguments given is that part of the problem is that it was not done under controlled experiment conditions, or that it was not supported with a quality assurance standard of some sort. Is there a way to take old work and put a quality template on it of some sort and move it out of the zone of not being useful because of that, and into the zone of being accepted? DR. RAABE: Every paper I read, I try to evaluate the quality of it because there are so many things that can happen. Experiments are very complicated. And I think in some cases, and I can't, you know, pick -- as I say, every paper sort of has to be looked at separately. You have to look at the study and figure out what the potential flaws are. Sometimes there are big ones. And those flaws can lead to great uncertainties, which makes you doubt whether the results are meaningful. That is why repeated studies that show the same thing are so important in science. You know, we know about cold fusion, for example, you know. Whatever happened to cold fusion? Well, it wasn't repeatable. And you could go through the original paper and say, well, you know, it looks right. Okay. So, this is the thing, there are all kinds of pitfalls that even the best scientist can fall into these pitfalls, even trying to be careful. And so, yes, every time you see a result, you have to say, well, what -- you know, is this correct, or are there other problems? And you try to evaluate that. In some cases you can see there are problems. And, usually, the kind of problems you see, for instance, animal studies is the author does not tell in any detail how they selected the controls. That is one of the big problems that occurs in so many studies. Controls are so important. In the case control study, you have to know something about the controls if you want the confounder situation to be stable. And, typically, you know, I have just got to get on to this, there are lots of studies that come out. Here is the Rocketdyne study, you probably heard about this, it made the news last year, out of UCLA, where they -- lots of studies like this, small studies, where they are looking at nuclear workers, and they are finding, in effect, and they are saying that radiation is much more dangerous than we ever believed because they found a statistically significant effect at a very low dose. The exposure of these people was very small, but there was a statistically significant effect to higher exposed people versus lower. And we look at it and say, well, -- and there are lots of these. There is the Steve Wing paper, several of them. What is going on here? How -- you know, because this is going to happen. You are going to see this kind of alternative paper in the literature. I am sure this is published in some statistical journal now. Well, there is a big problem with these epi studies. The problem is that the confounders are very difficult to work with. The other kinds of exposures that occur are very difficult to quantify, and when the study is done, the only good measurements that the researcher can find about these workers is the radiation exposure, because it has been documented perfectly. You know, if you are doing any kind of fitting of data which has multi-factorial data, one of the principles of regression is the measurements that are made with the greatest precision tend to dominate the response, even though other factors are actually causing the response. So you get the impression that the best measurements have a cause-effect relationship when all they have is an association that is related to the way which they are done. But we have -- okay, what are the confounders? Well, cigarette smoking. In this case, I talked to the author. He based his conclusion on four cancer cases in the high dose group. One was a Hodgkin's lymphoma, which is not believed to be radiation sensitive anyway, one was leukemia, and two were lung cancers. And I said to the man, the two that were lung cancers, were they cigarette smokers? And he said, I don't know. Well, what about cigarette smoking? Well, we took some side groups and we tried to balance it and it looked like about the same number of people were smokers in the control group as the exposed. But he didn't -- but they didn't do it, it was a side study. They didn't actually do it in the main study. So he was basing this -- you know, okay, well, the principle of confounders is that if your control group has the same percentage of smokers, obviously, there is also dosimetry there. How much do they smoke and so forth? But if they have the same number, the biostatistician thinks he has got it covered. But if there is only four cases, or two cases that you are dealing with, forget it. The normal proximation doesn't work for two cases. DR. HORNBERGER: If there are four cases in the high group, how many in the low group? DR. RAABE: Oh, well, there are lots, I have the numbers. DR. HORNBERGER: No, no, no. But four cases -- DR. RAABE: A lot. Lots. But the low group is a big group of people and the high group is only 20, or 17 people. DR. HORNBERGER: Gotcha. Gotcha. DR. RAABE: But this comes out, you know. They had a big press conference. Let's see, they -- I don't have them all here, but they had a big press conference over, you know, 17 workers, two cases, in the high group. Three cases in 210 workers, lower down, and six cases in 723, and then at the lowest group, three cases in 1,333. Well, that becomes statistically significant -- two cases in 17 workers. Well, you say, well, okay, well, leukemia is involved there. Well, what about their exposure to organic solvents? Well, we didn't measure that. There are no objectives for that, we couldn't figure that out. Did they smoke cigarettes? Well, I don't know, we don't know. Did those two cigarettes? We don't know. Didn't you look? No. But this makes the news. Steve Wing came out with a study that was the classic in epidemiological fishing expeditions, where you look through all of the data, you know, 40 different kinds of cancer, and find one that seems to be increased with dose. This was multiple myeloma that he found. Actually, it wasn't increased with dose, which is kind of interesting. There's four labs. He took Battelle Northwest, Oak Ridge, I think -- I am forgetting what the other two labs were, but he had four DOE laboratories that he was working with. And he look at this multiple myeloma. Battelle Northwest, in 1979, Ethel Gilbert reported that there was an anomalously higher level of multiple myeloma in workers at Battelle Northwest. This didn't occur anyplace else. And you can have all kinds of random things happen with 40 different kinds of cancers in your list. Well, so, he had this as a starting point. And when he did the case control study, he found no radiation effect on multiple myeloma, but that didn't stop him. Then he partitioned the people into the age at which they started working, only he grouped people lower than 40 years and higher than 40 years. Bang! His computer program gave him a significance. And he ended up making a videotape that was shown to all the workers, you know, I am saying, you know, you have got this higher risk of multiple myeloma. You know, so, on the other side, I mean we have to -- we have got one side here with people coming in and saying, well, you know, radiation is really not that dangerous and maybe even beneficial effects. Then you have these other papers coming out from scientists who are recognized in way or another saying, oh, it is even worse than we thought. So that goes into the pot. What does the public hear? Well, the public heard this. They had a big press conference. It made all the newspapers in California. The public heard about Steve Wing. They hear these things, you know, multiple -- you know, this cancer occurs up there. And the workers all had to watch this tape to tell them that they have an increased risk. It is a faulty study, it is very obvious. DR. GARRICK: While we have you here, because we have to break for lunch here pretty soon, but what in your opinion, both of you, has been the most important advancement made in, say, the last five years in the arena of understanding low dose response, if anything? If you want to pick a different time period -- DR. RAABE: Twenty years? DR. HORNBERGER: Well, that answers your question. DR. GARRICK: Yes. DR. RAABE: If you go by the NCRP's newest report, there hasn't been much new because they basically are saying -- DR. GARRICK: Because this seems to be a point of debate too, between the LNT supporters and the nonsupporters, where the nonsupporters seem to think that there's been quite a bit of work done that would be evidence of a nonlinear -- DR. RAABE: Some of the studies that are cited by some people who say that you can't believe the linear no threshold are studies that just show you can't discount the possibility of no risk. They don't disprove the linear no threshold and there is a big difference between saying your statistics are such that I can't rule out zero and saying that LNT is wrong. Of course the Cardis study is the biggest one that has been done with the most workers that I know of in one study and I think very carefully done overall in terms of the epidemiology and the best biomathematical methods, and I know Ethel Gilbert personally. I think she is a very good biomathematician. She was involved in that. And what do they show? And I heard Ethel Gilbert -- they say, well, I am repeating myself, it doesn't show anything particularly. I mean we have a very good record. We can't prove or disprove anything within the limits of statistics. They do believe there is a leukemia effect but when I look at leukemia effects and I see it is not consistent, it only occurred at two places, one in Canada, one in Europe, didn't occur in the United States, sounds like it wasn't radiation. Sounds like a confounder. DR. GARRICK: Charles? DR. FAIRHURST: A couple. In that period what has been the support? Is there support gaining for hormesis or is that something that was not considered significant 15, 20 years ago and it is seemingly getting greater attention or greater credence? DR. RAABE: Well, I don't -- I haven't personally worked in the area of hormesis. I work with data and try to fit models and so forth. Now sometimes you see things that look like a beneficial effect. Yes, the dogs in our studies with Strontium-90 that lived the longest were the ones in the lowest dose group. DR. FAIRHURST: But we are talking about advanced in the last 20 years. Is there a scientific sort of credibility growing or greater evidence that it is real based on basic mechanisms or basic understanding? DR. RAABE: There are a number of studies that have been pointed up in the last few years that suggest a beneficial effect of -- DR. FAIRHURST: That is what I was pushing Art Upton about yesterday and he seemed to agree to it. Could I ask quickly the other question? It seems to me that you alluded to it yesterday somewhat. This great variation in background, and seemingly no effect, I mean what can you do with that? Apparently you can't treat it statistically but there must be some way that evidence shows there's a variation. DR. KEARFOTT: That background is extremely variable. DR. FAIRHURST: I agree -- DR. KEARFOTT: Hundred foot dimensions -- DR. FAIRHURST: With no apparently correlation to cancer. DR. KEARFOTT: That's possible. DR. FAIRHURST: That is what I am hearing. DR. RAABE: Well, let me give you some real numbers, okay? I did the calculation for the 100 millirem per year, okay? Most of us get about 300 millirem per year, so that would predict about a one -- if you believe the linear no threshold, if you believe it is the upper limit that would predict, upper limit of about 1 percent lifetime risk from cancer from this background level. Now the average person in the United States, what? -- 35 percent of the people get cancer? You can't find that in the noise. I mean if you go to Utah, where people don't smoke very much, the cancer rates go way down but their radiation level goes up. Well, even if there was a special increase of a couple percent in their risk due to the radiation, the drop in 10 percent that occurs because they don't smoke overwhelms that. DR. FAIRHURST: Right. DR. RAABE: In Colorado the average dose to people, effective dose to code, is about 900 millirem, about three times higher. Colorado is 48th in cancer in the United States. I have the numbers here if you want to see them. Lung cancer, Colorado is down. Only Utah is lower than Colorado in lung cancer. Most of this extra dose is from radon and Utah is down there. D.C. is 48 cancers per 100,000 and Colorado is 35 -- this is lung cancer in 1995. So let's take the 900. Well, that would predict about a 3 percent lifetime risk of cancer. We are still looking at this background level. It is lower in Colorado than here but I don't know if you could statistically ever see if that 3 percent were real. Can you see it amidst the confounders? DR. FAIRHURST: Yes, but can't you come to a conclusion that given all of the cancer-causing agents that are bounding in the world today, radiation is not a significant component. DR. RAABE: Absolutely right. Even if you believe LNT. DR. FAIRHURST: The public heard that. DR. RAABE: Even if we believe LNT, the people who are arguing LNT are arguing for a very low risk and low dose and the people who are arguing other things -- are arguing for a lower risk. DR. FAIRHURST: But can I turn it another way and say you are throwing billions of dollars at the LNT hypothesis or protection against radiation and say for god's sake put that money into stopping people from smoking. DR. HORNBERGER: You're too rational. DR. FAIRHURST: Commissioner Dicus yesterday said what is the public willing -- if they are willing to pay it, we'll pay it. I think we are not serving the public by not -- I think it was one of your points -- I know your risk information and risk doesn't work but there's got to be some way you can inform the public of the stupidity of some of these allocations. Maybe I am still -- DR. RAABE: One response I have gotten from the public, I like to use comparisons. The risk of a few extra millirem is the same risk as moving up a thousand feet, you know, so you if you move to the mountains you are going to get the same dose, but in a discussion with the public one thing I wanted to bring up was if you come up with these numbers, these numbers that we play with, they are pure speculation, mind you. The Health Physics Society is right. Below 5 rem you cannot come up with a quantitative value that doesn't have such gigantic uncertainties that it is almost meaningless, but if you take these numbers to the public and say well, you know, the risk is only three-tenths of a percent of getting cancer -- "Well, what about those people who get the cancer?" DR. FAIRHURST: Oh, sure. Sure. DR. RAABE: That is what I have been told -- but what about those people who actually get those cancers? DR. GARRICK: Just to push Charles' proposal a little further, if you took a place like Central City, Colorado, where -- DR. HORNBERGER: Where some of us have claims. DR. GARRICK: -- where some of own mining property -- [Laughter.] DR. GARRICK: -- and it's 1000 millirem or whatever, and another similar location, similar population, full time residents of course, where it is about 100, are we saying that we still couldn't control the analysis well enough to do a credible comparison? DR. KEARFOTT: Only a good epidemiologist I think could give you that answer. DR. GARRICK: Yes. DR. RAABE: Yes, you are asking an epidemiological question. The question is whether you can do a case control study where you can control enough factors to reduce the background level or to control for the background level of cancer and we know about cigarette smoking. That is easy. But we don't know about other things and so I don't know. That is an epidemiological question. DR. KEARFOTT: But it sounds like a hard one. DR. GARRICK: But they have pretty good information on some of these things, like you say -- like cigarettes. We seem to know everybody that smokes in the United States. DR. HORNBERGER: Yes, but my suspicion is that perhaps if Central City were the size of New York City that you might have a chance but when you have a few hundred people living in Central City, even on the sample size basis you are going to be really -- it's tough, and that is not the hardest part of the problem. I still think they have these controlling for lots of other things. DR. GARRICK: Well, it's unfortunate that we have a phenomena that is so easy to measure as radiation and we have so many measurements as we do on it that we can't do a better job of answering some of these questions, but I guess you have convinced me of the problems. All right. I guess the other thing I would ask is sort of in closing of this session are there any other comments that you would like to make, nuggets that you have rethought? You have given us an excellent discussion of what you have observed from the discussions of the last day plus, and it looks like it is pretty much now up to the committee to figure out what we want to say about this, but before we do adjourn this segment, I appeal to you if there is any other parting observations or comments that would help us. DR. RAABE: I would like to repeat one thing that I mentioned in passing. You asked earlier if we needed another study. DR. GARRICK: Yes. DR. RAABE: If someone said, you know, do you need another study, I'd say well, you know, I would really like to see a study where the Committee has a charge to look only at protracted radiation and try to piece together all that you know about protracted radiation exposure. I think that's the target of our problem, it's the source of our problem. I also like the idea of doing some targeted analyses of specific radionuclides. DR. GARRICK: Yes. DR. RAABE: All that we know about plutonium, and don't leave out the animal data, because there isn't any human data. It always puts me in shock that we spend all these multimillions of dollars on very elaborate animal studies, and when you read the reports that are being produced, to a large extent that information is not used. DR. GARRICK: Yes. DR. RAABE: And usually it's this hidden idea well, you know, human data is more appropriate, you know, animal data is animal data, you know. So although the animal data are really well controlled and the human data are not, and the animal dosimetry is very precise and the human data dosimetry is very imprecise, to not use the animal data -- anyway, that was my main thing about the protracted and the targeted radionuclide. DR. GARRICK: Kim. DR. KEARFOTT: I tend to be naively optimistic in that there must be some opportunity, somewhere, to break the box. And I was very sort of captured by Dr. Fairhurst's comments about the public and, you know, can't you do this another way. So somehow there has to be a way of taking a different approach to analyzing and presenting the data that we already have and have a truly independent group figure out how to synthesize things. And I think that's the only way we'll break a box in which one of the walls in the box is the public and the other wall in the box are the technical people. DR. GARRICK: And I think that complements exactly what Dr. Raabe just said, and all we have to do is figure out who. DR. FAIRHURST: Could I throw out -- DR. GARRICK: Yes. DR. FAIRHURST: One even more extreme thing. You, I've actually talked -- do you know a fellow named Crowe at the University of Wisconsin who is looking at projections? It's always interesting to me to see how people project data, et cetera, and if it has a negative effect, you keep it in, and if it seems to have a positive effect, you say well, you know, that's a bit too -- let's push it out, because -- one of the things that's interesting, that if you're -- there's a big stimulus now to do fundamental biological research on the causes of cancer or the effects on DNA, et cetera. Now presumably if you discover this research is fruitful, not only will you be understanding perhaps the causes of cancer, but possibly ways to reduce its impact, or I wouldn't call it a cure, but somehow to put preventative. And so -- and the next thing of course is, as you say, that people ultimately die of old age, and if you push the age out, presumably you're eliminating other diseases and leaving one of the most intractable cancer to -- tend to increase the percentage of people dying. But if you start using similar sorts of logic, if you like, or illogic, to extend, what's the reality that the causes of cancer will be a major component of a problem 50 or 100 years from now? Do you see what I'm saying? If we are pushing this research, and it should be done, and if it's successful, then you're eliminating the problem, or partially the problem, even if you do have -- you find out that there is a high consequence of a dose 50 years from now, you may be able to offer that person some remedial treatment. And I'm trying to figure out how you put that into -- DR. RAABE: It's sort of like the case with thyroid exposure. We know that people might have gotten high doses of I131 years ago, but thyroid cancer's almost 98 percent curable. Is that what you're saying? DR. FAIRHURST: Yes. DR. RAABE: And presumably for other kinds of cancers there are going to be even more fantastic methods for treatment. DR. GARRICK: In fact, the health effects models that we've used before the NRC got into the risk business were based on essentially that, that 90 percent of the thyroid cancers were recoverable. It sounds like the ode of the radiation researcher is to want to live long enough to have died from radiation-induced cancer. [Laughter.] DR. RAABE: When I give the talks on the studies I did with internal radionuclides, I always point out that if you removed all other causes of death, you would eventually die of radiation-induced cancer. DR. KEARFOTT: I just wanted to comment that the treatments depend on understanding of the mechanisms, and so that's why I support continuing sort of biological research, because that's where those answers are going to come from. DR. GARRICK: George? DR. HORNBERGER: Yes, a question again, sort of a hypothetical -- well, it's not hypothetical, but it follows a little bit on what Charles said. One of the things that we're grappling with right now is of course Yucca Mountain, and here we're talking about setting standards out at 10,000 years and beyond. Currently the draft standards call for a 25-millirem all-pathways standard, and as you've heard, there are some arguments with EPA as to whether or not that is or isn't the right standard. Could you just give us your -- even if it's a gut-level feeling -- on what a standard -- a reasonable standard, radiation standard, should be for that kind of problem over that kind of time frame. DR. RAABE: Well, there is no basis for saying that 25 millirem is different from 15, that is for sure. The Health Physics Society's position statement is that you can allow 100 millirem per year, and I stand with that. I don't think there is any known or expected risk at all. Protracted exposure -- DR. HORNBERGER: So, 100 millirem at 10,000 years, that seems reasonable. DR. RAABE: Sure. DR. GARRICK: All pathways? DR. RAABE: All pathways? DR. GARRICK: Yes. DR. RAABE: Yeah. I don't think there is any known expected risk associated with that kind of exposure. DR. KEARFOTT: I also support Health Physics Society's statement in there. DR. FAIRHURST: You know that the significance of that with Yucca Mountain is that DOE's own studies show that the risk is -- or the does is rising beyond 10,000, even though we set our standard at 10,000. And so the public is going to go jumping through the roof if you, say, set it at a time when it is not the worst. DR. KEARFOTT: I have a terrible problem with this whole sort of long-term waste stuff, and that I view internal dose assessments and the number I can give for you next year has an order of magnitude uncertainty in it, when you take everything into account, and then you tell me to extrapolate 10,000 years, I mean that is the problem I have with all that. DR. GARRICK: Well, that is a valid problem. What I would like to do is invite our consultants to enjoy this afternoon with us if you like, in a slightly different position. We are going to hear some presentations on the clearance rule and also on the decommissioning standard review plan. I don't know what your travel plans are. I just want to indicate that you are welcome to be here if you are going to still be in town. Any other parting comments before we adjourn for lunch? This has been an excellent session and I think it has coalesced a number of ideas and points that gives us a basis for trying to work up some sort of rational report. Dana, have you got a parting remark? DR. POWERS: I guess maybe a couple of questions. One question, a lot of research was outlined that could be done. Have you any idea why it is that the industry that bears such high costs is not an active sponsor of research in this area? The second question would be, have you seen anything that refutes the logic that we can set a standard of what is safe enough, utilize a linear hypothesis that may or may not be bounding, and set risk standards based on that? DR. RAABE: The first question was -- DR. POWERS: Industry. DR. RAABE: The industry. I don't know anything about that. DR. KEARFOTT: I suspect that it might be because industry doesn't want to fund very long-term purely scientific research, particularly an industry whose main focus is power. DR. GARRICK: Why don't we ask Ralph to make a comment? What you got to say about that, Ralph? MR. ANDERSON: My name is Ralph Anderson with the Nuclear Energy Institute. I am sorry I couldn't join you this morning, I was very busy at our offices help prepare our final testimony on appropriations for this year for DOE and NRC, and the reason I had to stay behind is because we were completing our section of the testimony that is supportive of the DOE research funding and encourages continued research in this area. So, first of all, I think the statement is incorrect. And, in fact, last year and the year prior, we had many interactions with Senator Domenici's office in which we were very supportive of his vision for research in this area. So I think that is a misunderstanding of industry's position. Also, through EPRI, which is our research arm, we have, in fact, invested money in the past to do feasibility studies of epidemiological studies, and primarily because of economic reasons, and because we also reached the conclusion that the studies would not be definitive, we determined not to go forth. But I think that is reasonable in any mode of research, you don't proceed with research that you don't expect to be fruitful, especially at a potentially high cost. So I think that there is a misunderstanding of industry's position on such research. DR. KEARFOTT: The second question -- DR. POWERS: Am I misunderstanding that you are not funding any research in this area, especially this litany that was given to us? MR. ANDERSON: I beg your pardon? DR. POWERS: Am I misunderstanding that you are not funding research, especially in this litany of research suggestions that we have had? MR. ANDERSON: When you say we funding, I am not sure what opportunities for funding we specifically have. DR. POWERS: Well, it seems to me that there are apparently a large number of people in the academic community wiling and anxious to conduct studies ranging from cells in petri dishes up to epidemiological analyses. MR. ANDERSON: I am sure that is probably true, having worked once upon a time in the research community, and not to make light of what you say. I suspect there are probably thousands beyond those that we are aware of. If you are suggesting would we directly fund such research through the universities, I suspect not. We might encourage such funding through federal funds, and let me tell you why. What we ascertained in '92 when we looked at going forth with an industry funded large scale effort on epidemiology, one of the conclusions that we reached after talking with a lot of the people who were so-called stakeholders out in the public community was that any study that we funded would be found highly incredible unless the results were that all radiation kills all people. And so, in that sense, we have done indirectly, we support the NCRP, we have for years. We have given money to specific efforts at NCRP. As I mentioned, we have supported primarily literature reviews through EPRI, subsequent to our '92 decision. And then we work through the Congress, because we think that an understanding of the issue actually is a little broader than, quote, "just the industry." We think in the public interest to have better answers to the questions. And, you know, we have been very supportive of research through federal monies. But I think we would shoot ourselves in the foot if we were to try to pass money directly over into the research community. It just seems to pollute the well. I would be happy to talk further about it, but that's -- DR. GARRICK: Okay. I think we want to -- I guess, James, you have one final -- MR. MUCKERHEIDE: Over the last 20 years or so, I have talked to the industry about funding research. It has always struck me as very surprising, but quite rational why industry does not research. As a regulated utility environment, two things were fundamentally true. In their regulatory process, they got some money to support EPRI in the early days, but compared to chemical industry or oil industry, or any of the other private industries, they didn't have the same approach, nor did they have the same incentives. Number two, they were party to a government ownership, essentially, of the nuclear enterprise. They were licensed and regulated under very rigid conditions, the ownership and the responsibility under the licensing regime, and the authority for byproduct materials and lots of other issues were all very -- pretty much closely hidden by -- held by the government, and so there wasn't a sense that there was something to do. Thirdly, it was very clear that if we have to spend a great deal of money to meet a requirement, we pass it through to the rate payer, so some of the issues that we addressed in the '70s and in the early '80s were pretty much set aside as, well, if we have to pay another $100 million, we just put it in the rate base. And, finally, in more recent times, I think if we begin to see this industry become more privatized, the potential that they will join the arena of industries that actually fund research, I mean we have a chemical industry Institute of Toxicology. There is no nuclear industry Institute of Radiobiology. There is an entire world of programs that chemical industries and other industries fund relative to their own self-interest, but being a quasi-governmental regulated enterprise, primarily, it just never really was in their interest. So I think one of the things we hope to see change is under the new tendency to be more privatized, that the interests will begin to revert to having more self-interest and seeing long-term research and long-term interests come to the fore. DR. GARRICK: Yes, and I think, fundamentally, unlike the chemical industry, the automobile industry, many other industries, the nuclear power industry had its beginning in a government arena where most of the research was performed by the government. Okay. I think we will break now for lunch. [Whereupon, at 12:05 p.m., the meeting was recessed, to reconvene at 1:02 p.m., this same day.]. A F T E R N O O N S E S S I O N [1:02 p.m.] DR. GARRICK: The meeting will come to order. We are now going to shift into a little different area of activity. We are going to hear about the Clearance Rule and also about the Decommissioning Standard Review Plan this afternoon. It is my understanding, Frank, that you are going to lead off the discussion and I will look to you to introduce the subsequent speakers, okay? Frank Cardile. MR. CARDILE: Go ahead and put the next slide up, Giorgio. Basically this is just an introductory slide on page 2. We are here to talk about -- we are here to kind of lay out the progress of where we are in development of a Clearance Rule, basically, as it indicates here, give some background, indicate where we are, the recent activities that we have gone through and completed, what are our upcoming steps, what is coming up next that we, the activities that we are going to be conducting. Then we will get into some specifics of an issues paper that we have completed and that we are going to be sending on to the Commission shortly, and then Tony Huffert, to my left here, will discuss some particulars with regard to development of a technical basis that we are going to use to support any rulemaking effort that we get into. We are trying to let you know where we are. We have made a lot of steps here fairly recently and we have got a lot of steps going on in the next few months and year and we want to let you know what is going on. On the next slide, on page 3, to give you some background on how we got to where we are, in SECY-98-028, which was sent up about a year ago in February of 1998, the Staff went to the Commission and requested Commission guidance or direction on three options for how we should proceed with regard to clearance, that we could either continue with our current regulatory structure, which basically relies upon the use of regulatory guidance, or we could support EPA in their efforts at issuance of a standard on clearance, and then follow them up by issuing a conforming rule or we could proceed independently to issue a NRC rule for NRC licensees. The Commission came back in June of 1998 and directed us to proceed with the third option that you see up there, the third bullet, and that we should promulgate a dose-based rule on clearance, we should begin in FY 1999, and that we should use an enhanced participatory rulemaking process similar to Part 35, the process that they have gone through and also similar, although they didn't mention it or they didn't specifically delineate it, similar to the process that we went through on the decommissioning rule or the cleanup rule in 1992-93 timeframe. So with that direction, if you go on to the next slide, on page 4, the Staff received that SRM in June of 1998 and proceeded with a number of steps to get started and then on January 27th of this year, 1999, we sent up to the Commission a SECY paper, SECY-99-028, describing to them our rulemaking process that we envisioned for clearance. Included in that process, and not specifically noted on the slide here, is that we were forming a working group and a steering group on clearance, on the clearance rulemaking effort. The purpose of the working group and steering group is obviously to assist in the preparation of the document. The working group would be made up of working staff from NMSS, NRR, Office of State Programs, OGC, and Research. Obviously this is a wide effort going across both licensing offices, NRR and NMSS, also the Office of Research plays a role in assisting with the development of the technical basis to feed into the rulemaking. OGC of course provides the legal input and OSP provides input with regard to compatibility and other areas. The steering group -- in addition to those members of the working group we also have a working group member from an Agreement State, from the state of Texas. We also set up a steering group made up of management from those particular NRC offices to give us early management direction on some particular areas and also to expedite the concurrence process. This working group-steering group process has been used and was used also on the cleanup rule, which was completed a couple years ago. We also have a steering group member from the state of Illinois, an Agreement State, so we have some state representation on this panel, on both of these panels. We also are proceeding with not only -- as part of our rulemaking process not only the standard rulemaking procedure but we also, as the Commission directed us to do, are supplementing the process with an enhanced participatory rulemaking process the object of which is to obtain early and meaningful public input into any rulemaking that we would conduct. As noted there then, on the first bullet, really this first bullet describes some of the specific plans with regard to this enhanced participatory process. Two of the key components of that process are that we would publish an issues paper in the Federal Register. I will talk about that some more as we are going on to the next slide. Basically this issues paper will go out there and be published in the Federal Register and its intent is to foster discussion on the issues associated with any rulemaking early on, so that we know -- we can get some information. We also hold four facilitated public meetings at different geographical locations. We anticipate those beginning in August of this year and going through November of this year. Right now we anticipate those meetings being in Chicago, Atlanta, San Francisco, and Washington, D.C. The last one would be in Washington, D.C. We would invite the ACNW members to attend any of those public meetings and in particular we also anticipate that in the timeframe of those public meetings, either in amongst them when we can reflect what we have been hearing, or perhaps when we are done with -- when we are completed with the public meetings we would hold a meeting with you to go over your views on the specific content of the issues paper. The idea -- you may be familiar with a facilitated meeting. The idea of facilitation is to not only just hold a meeting and say what are your views, but to broaden participation to make sure that different views are represented and to make sure that the view that are represented are presented at the meeting, so it is not just open up the door and hold a public meeting but there is a process that we go through prior to that where we invite specific interests and then we let them know early on what the questions are and bring these interests into the meeting. We are in the process right now. That process of facilitation will be one in which we both contract out some of that work and also use a person here, Chip Cameron, who has done this type of work at Part 35 meetings prior to this. The second bullet on the page, going back to the content of that Commission paper, we discussed the specific technical basis that we will still need for this rulemaking the schedule for developing that technical basis. Tony Huffert later in this paper, Section 4 your notes here today, will be talking to some of the details about that technical basis. In broad terms, we are right now in the process of getting on board the contractors that we need to assist us in that process. We plan to have those contractors on board -- there's four separate contracts and four separate contractors. One is a competitive bid. One is a task order on an existing bid. Two are with Government contracts. But we plan to have them all on board and running shortly and certainly completed by either June or July of this year that they would all be on board. Finally, the last bullet on this page, the SECY paper indicated that following completion of the public meetings that in probably February of next year we would bring the Commission another paper indicating the results of the meetings, where we stand on the meetings themselves, and what we learned from those meetings, and then also where we stand on the development of the technical basis and where we would go from there. Okay. The next slide as the first order of business are preparing this issues paper. The point of the issues paper is to, as I said, foster discussion on the issues before we would get into any rulemaking. This paper has been completed. It's currently in NMSS office, concurrence process, the various offices and the steering group members have concurred on the paper. We plan to send it to the Commission for information this month, and then we plan to publish it in the Federal Register for public comment next month, in April. We would invite written and electronic comments on it. We will indicate in it how it can be obtained, both electronically and how paper copies can be obtained from the staff. The comment period of the paper will remain open until of course the last public meeting in November, and then we would also note in the FRN notes that the issues paper not only being available for people who have sent in their written comments but it will be the format of holding the public meetings. Following the public meetings of course we'd be in a better position to decide what direction to proceed. So getting into the details of a little bit of what's in the issues paper, on page 6, the next couple of slides, what we did in the issues paper is we had a background section in which we try to lay out in as direct and clear a manner as possible where we are now, why we're doing what we're doing, why this is different than what we've ever done before, and what we plan on doing, some of the context of why we're doing what we're doing. That's Part A of the issues paper. Part B of the issues paper is ask some specific questions -- it raises four specific issues, lays out alternatives under each issue, and then asks some specific questions to foster discussion in these public meetings. So this first page here that you see, page 6, is part of the background, discusses some of the rationale for why the NRC is considering rulemaking in the area of clearance. Basically it notes that Part 20 already contains criteria on the amount of radioactivity and gaseous and liquid releases that may be released from a nuclear facility to the environment. Also subpart (e) of Part 20, which was recently added, has criteria on the release of decommissioned lands and structures. This part focuses on protection of persons -- focuses on protection of persons coming on the site and using a decommissioned structure or using decommissioned lands after license termination. It does not focus on release of metals or other equipment or other things from the decommissioned structure to the public. So it was focused on the structure and the lands. However, unlike -- like I point out here, the existing criteria for liquid and gaseous releases and lands and structures, there are no specific criteria in Part 20 governing releases of solid materials. Now I don't get into this here, but the issues paper discusses in some amount of detail or provides some information about what these solid materials are. It notes that the solid materials are, for example, metals, equipment, furniture, and any other material that could be at a nuclear site. It also points out that some of this material would have no radioactive contamination, for example, many, many of the NRC licensees or sealed-source users have equipment and materials that have no contamination because their source is a sealed source and there's no contamination on site. But it points out that other materials obviously at some other facilities can become contaminated because they're in perhaps like a reactor facility or a laboratory facility where there's contamination which may leak from a pipe and particular equipment may be there and become contaminated, or obviously if a piece of equipment is part of the radioactive system, like a tank or piping or pump systems, those would obviously become contaminated. So the paper tries to point out that there's a difference in levels between the amount of contamination that any particular piece of material can have. The bottom line or the bottom tick on this page is that the Commission's thought is that in order to provide -- the rationale is that to provide consistency in the framework for releases of all materials we're considering this rulemaking. This would put us in a better position to avoid inconsistencies between standards and also allows us to deal with requests from licensees, especially in the future. As more facilities reach decommissioning, there may likely be increased requests for clearance. On the next page, on page 7, again this is more background, the issues paper notes that anytime the Commission proposes a rule or considers proceeding towards rulemaking, it considers alternative courses of action. Three of the courses that we lay out in the issues paper as possible courses of action, and again this paper is intended to foster discussion. It says that these are the things we've thought about based on our knowledge that we have, and obviously this is a jumping-off point for anyone else -- or for anyone to say either changes or suggestions or permutations to these courses of action. Basically the three alternatives that we lay out are permit release of the materials for unrestricted use if potential doses are below a certain level. This level obviously would be worked out during the rulemaking process. The process that we've been using this word "clearance" and "unrestricted use" back and forth a little bit so far today, and it has been used back and forth. As you may well know, internationally the definition of clearance is release of material for unrestricted use, so that clearance would be restricted to the -- or would be used for this first alternative. Because this rulemaking is proposing or this effort is proposing alternative courses of action besides just unrestricted use, we have to be careful not to just call the whole thing clearance. But anyway, unrestricted use or clearance of materials could include recycle or reuse of this material into either consumer products or industrial products, or you could just release material for unrestricted use and it could wind up in a landfill. A second alternative that we note is that perhaps rather than just putting the material out for any use, we could restrict its use to certain authorized uses which would probably result in the public receiving -- the general public receiving lower doses. And a third possible option is that neither unrestricted nor restricted use would be permitted, but any material that had been in radioactive service or had become contaminated because it had been in an area where material was used -- licensed material was used or stored would just not be permitted to be released. This is a third option which we indicate in the paper. Going on to page 8, again in background this is something that we obviously are aware of. There have been previous Commission efforts to address release of solid materials. In particular the BRC policy from July 1980, you know, you can read the details of what the BRC policy was intended to do, but it basically was a broad policy statement saying -- put out as a way around which to formulate future decisions regarding regulations or licensing decisions. It has four principal components, one of which was decommissioning lands and structures, and another one of which was setting a standard for release of solid materials for recycle. Notice that it only talked about recycle, didn't talk about clearance in general, which can mean also general release or where material could wind up in a landfill. However, based on, you know, public concern with this policy, some of that public concern being just the nature by which it was developed and some of that public concern being the content of that paper, the Commission decided that a more extensive public involvement process should be followed with regard to the policy, but before that larger process could occur, the -- and so the Commission put a moratorium on the policy. Before any additional work or public involvement could be conducted, Congress enacted the Energy Policy Act of 1992 which revoked the BRC policy statement. Moving on to the next, on page 9, continuing with regard to the BRC policy, it's our thought that what we're doing now is not just the BRC policy -- that was a broad policy-setting approach -- this effort would aim at establishing some specific requirements and would aim at using the procedural requirements of the Administrative Procedures Act or the APA, as noted in the second check here. The APA of course requires us to go through the NEPA process, which would include an evaluation of the environmental impacts associated with any clearance rulemaking, which would include a full assessment of potential scenarios and pathways of exposure by which people might become exposed to clearance pathways. The APA or our process also involves doing a regulatory analysis consistent with Executive Order 12991. And as a supplement to the EPA process, we would conduct an enhanced participatory rulemaking process. This APA/EPR enhanced process was conducted in a similar manner following -- has been previously conducted -- following the BRC policy being revoked, one of the components of that policy, namely the decommissioning lands and structures component, was -- we went through a rulemaking -- enhanced participatory rulemaking process on that in which we held public workshops. We put out a proposed rule -- an early draft of a proposed rule for public comment, and then went through the rulemaking process so that in July of 1997 we issued a final rule on decommissioning of lands and structures which now gives NRC licensees as well as NRC clear direction on how to review decommissioning of lands and structures, and it also gives the public clear information on how NRC conducts its business with regard to decommissioning lands and structures, and also what avenues are available to the public with regard to being involved in an individual licensing situation or case for decommissioning of a particular facility. So the point being that this APA/EPR enhanced process was conducted for the decommissioning process, and the process was completed in 1997. Moving on to the next slide, that was all background, we finally now get to the four broad issues that we are going out to the stakeholders with to get stakeholder views on. Again we want not only stakeholder comments, but we're also asking for stakeholder information. If people have some information about some of the things that are in here, and we'll talk about them a little bit, that's part of what we're going out to get also. And again, as I noted earlier, this comment period on the issues paper will be open through November. The paper we hope will be in the Federal Register in a few weeks, after going through the, you know, sending it to the Commission. If, again as I noted earlier, we would probably come back to you and get your specific views on particular issues, today our hope is that we can point out what we are laying out there is what some of these issues and what some of the questions that we're raising are, but after you have more time to digest them, we could come back to you later this year in amongst the public meetings and have another meeting. Again, the structure of the issues paper is that it lays out the issues, it lays out a couple of alternatives under each issue, and then it asks several questions under each alternative or each issue seeking advice or information or input from the stakeholders. The first issue on this page, issue number 1, is the broad question of whether we should even have a rule. There's some question -- there are questions raised as to well, we don't want a rule or, you know, why should there be a rule at all in this area. And so the first issue, even though the Commission directed us to prepare a rule, we thought it was important to address this issue by laying out the pros and cons of whether we should continue with the current case-by-case approach or conduct a rulemaking under the APA. Moving on to the next issue which gets to needing a little more detail. This is where we have the substitute page, I don't know if everybody got it. Basically, all the substitute page does is it tries to be less busy than the page that was in the stapled package. It is the same information, it just cuts it in half, or puts one thing on each page. As you can see here, Issue Number 2 asks, what are the principal alternatives for rulemaking that should be considered? It lays out, again, as we did earlier in the background, three potential alternatives, one being unrestricted use at different potential dose levels, or above background, or even no dose above background. These laying out of different alternative dose levels, including, basically, a background level, is similar to the process that we did for the cleanup rule, which we analyzed -- which we asked for public comment and also analyzed in the Environmental Impact Statement, both a return to background at the site, as well as different alternative dose levels that a site could be released at. We also list here the other alternative of releasing material for unrestricted use or not permitting any release of solid materials. And the third check is other as suggested by comments. Actually, when they went out with an issues paper for the cleanup rule back in 1992, one of the things that came back -- when they put out the issues paper, there was not a restricted release option, so that is why this other check here is important, because we may get some options, suggestions made in public comments that would add to the list of alternatives. Going on to the next page, that gets into -- tries to get into some of the details about what factors should NRC be using in making its decisions between alternatives. The first being the human health and environmental impacts. We talk about -- the paper talks about looking at assessment of, obviously, impacts to individuals, but also assessment of impacts to different population groups, and the paper also talks about the fact that there can be competing impacts, so that just by having a lower dose criterion, which obviously lowers -- a lower dose criterion for cleared material, while that obviously lowers the dose impact for exposure to that material, there could be a competing impact, that because you have to -- now, all that material, rather than going into clearance goes to, say, low level waste, the replacement of that fresh material, or that material with new mined material would have impacts associated with that. So we had a similar -- I keep referring to the cleanup rule, but we had a similar situation there. And so what we tried to do in the Environmental Impact Statement was balance both impacts that went down against impacts that go up. So that would be what we would be doing and we would be asking -- the paper asks specifically, what are suggestions for making this balance and what are some of the other impacts that are competing, both radiological and non-radiological? We also will be doing a cost benefit analysis using NUREG BR-0058, which is the guidelines for -- NRC's guidelines for complying with the Executive Order. We would be looking at all -- we would be looking, as part of this balancing, we would be looking at the costs of the whole process by which material would be cleared. We would be looking at the cost of surveys at the different dose levels that you see here. We would be looking at possible impacts, economic impacts on the scrap metal industry. Is there a potential that we would -- that alarms would be going off causing material to be rejected and sent back, and what possible economic impacts are associated with that. We would be looking at implementation considerations. Tony will be getting into some of this in more detail in a few minutes. The implementation considerations, of course, would include -- what are the questions or concerns about surveying large quantities of metal at these low dose levels, or even at dose levels near background or at background? As I just noted, some of the answers to these questions, like on the implementation or the environmental impacts, we will be developing in our work, but we are also asking the public to provide input to help answer some of these questions. And we will be looking at other international, national and state standards. Going on to the next slide on Issues 3, we will be -- Issues 3 in the paper tries to flesh out a little bit more information, or a little more detail about the potential for restricted use on releasing metal. One option being we could release -- or, I'm sorry, we could restrict the first use of solid materials to some authorized use, particularly, as it notes here, you could perhaps make steel beams that you would use in a structural support. We were at a meeting a couple of months ago where a gentleman suggested we could make military equipment. He was talking about tank treads, so, you know, rather than consumer products. So that can question can come up, or that is a potentially valid alternative which we should consider. A question that is associated with restricted use would be that because of the uncertainties in controlling material flow or where the material goes, we may need to require that the processing of the material into this first use be licensed by the NRC. So a question that is raised in the issues paper is, should NRC license the -- I guess, the manufacturer, for example, of the bridge structure? And, so, that would be -- that is a question that is raised. There are several questions that are raised in the paper, I could run down what they are, related to that, related to how long the restrictions should stay in place, what are candidate materials. What is a good set up for restricted use? An interesting question in the cleanup rule which we just issued, there is a restricted -- there is some parallelism, there is an unrestricted and restricted use of buildings and lands in the cleanup rule, and if there is restricted use, there is an opportunity for public involvement in how these restrictions are set up. In the cleanup rule, if you restrict use of a building or lands, you terminate the NRC license because it was decided that the public deed process of how a particular piece of land or building would be used can be satisfactorily covered by the existing deed process, just the local land set up. So, the cleanup rule for the lands and structures allows NRC to terminate the NRC license when the dose level is reduced to a low enough level and then the whole process of the restricted use, and the deeds and the lands only being allowed to be used for, say, industrial purposes, not a farmer, that is all an unlicensed use. Here, you may have, because, like I say, there is no -- I don't know if there is a deed process for tanks and pipes as they leave a reactor, so you may have to license how this material is handled until it winds up in a safe form. So that is the difference between the two rules. Also, the cleanup rule had a public involvement process where how these lands were used could be reviewed by the local populace so they could provide input as to how these lands and structures were used in a restricted way. Here, because you have metal that will come out of the plant and go anywhere in the country, having a public involvement process at a particular site maybe is different or may be more difficult. So these are questions that are raised in the issues paper. The second alternative that we list here is that we would restrict release of the metal to only a landfill site rather than allowing any consumer or industrial use at all. The rationale for that would be that this would cut out any direct public usage exposure pathway and limit exposure pathways to only what you might get from any landfill exposure, which is generally thought to be at least fairly well -- it can be fairly well defined, unlike perhaps consumer uses, which can be fairly broad. So those are two restricted uses that we indicate as potential alternatives. Finally with regard to the issues that we list, issue number four, which is on page 13, the Commission directed us in their SRM. Their other point that they made was that the rulemaking should cover all materials unless there was some factor that would cause us to limit the number of materials covered, namely that it would delay -- if we expedite the rulemaking to limit the materials covered in the scope, we should do so. Our technical basis that we have developed and which Tony will get into a little bit is basically right now limit it to metals, concrete, and to some extent soil, so one alternative is to limit the rulemaking to a select group of materials, namely metals, concrete and soil. Another alternative is to apply it to a wider group of materials, as you can see here, and another alternative would be to conduct the rulemaking on this wider group of materials at a later date and there are specific questions on that in the issues paper. The next page goes into the development of the technical basis and I will let Tony proceed from here. MR. HUFFERT: Thank you, Frank. I would like to point out some of the requirements that the Staff were given from the Commission in its June 30th, 1998 SRM on how to proceed with this rulemaking. They told us to develop a dose-based regulation as compared to a detectability based regulation, so we have been pursuing rulemaking at different dose levels, as Frank mentioned, from basically background up to 10 millirem with values in between. They asked us to focus on clearance levels above background for unrestricted use, which means do not include background doses or background concentrations of radionuclide in this rulemaking when you are doing your dose assessment, and they also asked us to consider existing work being conducted by the IAEA, other contractor analyses that have been performed, for example the Environmental Protection Agency has been working in this area and has done a substantial amount of work to date that we can draw upon. Also, speaking of EPA, we have been directed to look into NORM and NARM practices. Specifically they asked us to take a look at the practice to take coal ash and recycle it into building materials. We think that that would be a fairly interesting benchmark to consider when we are developing our own analysis. We have been asked to use realistic scenarios when we are developing the rule as compared to using really conservative analyses, and also to consider the materials that have been analyzed so far, which is iron, steel, copper, aluminum, and to some extent soils. On the next page I would like to talk briefly about some of the work that has been conducted so far by the Office of Research. They have been working for several years with other Federal agencies developing a draft report, NUREG-1640. This document covers iron, steel, aluminum, copper, and concrete. The reason for these materials being selected was that initial studies indicated that these materials would be of economic value and that these would likely be released from not only the NRC licensees but also DOE as well. These materials have been studied by other Federal agencies and we can draw upon that work also. They took a look at 79 scenarios for clearance and they specifically identified 85 nuclides to analyze. The 85 nuclides were obtained from looking at manifests, Class A waste, and then comparing that listing to work being done by the Environmental Protection Agency. DR. GARRICK: Are you going to say something about the basis of the scenarios? MR. HUFFERT: I can, yes. Would you like for me to do that at this time? DR. GARRICK: Well, if you are going to later, that's fine. MR. HUFFERT: Let me go to the next bullet and then I'll talk about that. We are planning on issuing this draft NUREG-1640 this month. Currently there is a Federal Register notice being developed by the Office of Research. We are hoping that we will have a fairly long comment period on that report so that it will extend well into the time that we have our public meetings, which will be running through the Fall of this year. About the scenarios, the 79 scenarios were arrived at through trial and error basically. The Office of Research looked at clearance, meaning there could be direct disposal of material, there can be direct reuse of material, and there also can be recycle of material. Recycle would involve materials being released from a nuclear facility as scrap. It would then be handled at a scrap facility where it would then get back into a steel mill where it would then be processed and then put back into use. DR. GARRICK: And that is what you mean by a scenario? MR. HUFFERT: There are actually two different models that were used to develop these scenarios. There's a material flow model in NUREG-1640 which has different scenarios of how this material is basically moving once it is released and there is also a dose assessment model and the dose assessment model has scenarios in there. These are basically exposure scenarios so the combination of those, it is my understanding, represents the 79. As far as the limiting scenarios, it turns out that consumer products are not the limiting exposure pathway and in many cases it is truckdrivers or it is workers at processing facilities. The workers at processing facilities would be, for example, a worker in a steel mill where the material can become airborne through different metallurgical processes and the material can be potentially concentrated so these are the sensitive scenarios that have led to the critical dose conversion factors. Further work is needed to develop our technical basis. NUREG-1640 really was focused on identifying realistic critical groups and calculating dose factors for each critical group. It did not get into collective dose assessment. It did not get into soils. As Frank mentioned, there has been some work done on soils for the decommissioning rule, and we can benefit from some of that work already done. But NUREG-1640 does not specifically address soils. We will have to develop more scenarios for the noncritical individual dose scenarios that are needed for estimating collective doses in population groups. We think that we have to take a look at population behavior. We have to take a look at the probability of a number of persons being exposed to both processing and the end products itself. NUREG-1640 does not cover that. So we are currently in the state of we have developed a statement of work. We are going to go out for competitive bid to a contractor to further refine that work. And we're also going to be doing more work in the area of cost-benefit analysis. The EPA has done work in this regard. However, the NRC has not. The third bullet on this page talks about some of the progress made by the EPA in developing the technical basis. In 1997 they released two reports. One was a draft technical support document entitled "Evaluation of the Potential for Recycling Scrap Metals from Nuclear Facilities." This is basically a data compilation report that discusses supporting analysis for a second document they prepared which is called the preliminary cost-benefit analysis and radiation protection standards for scrap metal. The NRC Office of Research has been working closely with EPA on these documents and I think it's a very good resource for us to use. We will continue to develop our technical basis in order to develop a generic environmental impact statement, a regulatory analysis to analyze the different regulatory options, and, as Frank mentioned, we have four statements of work that are being developed right now. Two of them have to do with implementation. I'll be intimately involved with those, as I'll be working on a draft regulatory guide. We are planning on going to national labs for that support. We will be focusing one contract on survey methodology, and we'll be actually focusing another contract on the detection of radioactivity, the actual radiation physics involved, since we are going down to such low concentrations of radioactive material in matrices -- DR. GARRICK: Yes, at some point I'd like to hear you comment a little bit about the problems that I can envision when you start talking about complying with the one-millirem requirement, the instability that -- the radiation instability that exists in some of these sites. It sounds like that's a tough challenge. MR. HUFFERT: We faced a similar technical challenge when we were working on the decommissioning rule, and I was involved in that. We were given a task to go from on the order of 30 millirem per year all the way down to basically background. We contracted with some experts in the field. We took a look at what was needed, and we actually came up with new survey approaches that were incorporated into MARSSIM. And that's been widely accepted. I think that we're going to be facing a similar problem here. The differences that the material that was analyzed for the decommissioning rule was basically on lands and structures, and in this case it's going to be incorporated in metal. And detecting alpha and beta contamination when it's found in a matrix of steel is almost impossible to do with the survey instruments. You might have to use other methods, for example, taking samples in order to do that. We don't have any answers for you today. This is under development. We started working on this in October, and we are currently in the stage of getting our contractors on board and looking at this problem. I can tell you that the staff has been involved in recent workshops in this area. I've attended a couple of them where this was discussed. And there is a lot of work going on both nationally and internationally in this area that we can draw upon. MR. CARDILE: Also I think the two contractors that you're planning on using are the ones that assisted you on the -- MR. HUFFERT: Yes. Well, we're hoping for that. MR. CARDILE: Okay. MR. HUFFERT: We're in the stages right now of trying to get contractors on board, and the one in particular is extremely good at radiation physics, and I think they would be invaluable to have on board, because they could help us in that area. The next slide was put together to present a snapshot of where we are today in our technical basis development and the work ahead of us in order to complete this rulemaking. On the left-hand side of the table we have basically the NEPA analysis, which is referring to our generic environmental impact statement that we'll be developing, the regulatory analysis, the draft reg guide, and then public participation. The middle column discusses the regulatory requirements or procedures that we would be following in the development of our technical basis. For example, under NEPA, we have fairly clear guidance on how we should proceed in our own 10 CFR Part 51. Under the regulatory analysis, as Frank mentioned before, we have Executive Order 12866, an SRM, and also a brochure report on how to conduct that. We just talked about the draft regulatory guide, how we need to develop practicable instrumentation methods, and as far as the public participation, we would be holding four public meetings during this year throughout the country, and that will be satisfying two requirements. It's not only going to be satisfying the 10 CFR 51 process but it will also be satisfying our own enhanced participatory rulemaking process. To the right we have the technical information needed, and to give you a feeling of where we are today, we have items A through L listed. We only have item A and item K at this point. Item A is NUREG-1640, which talks about the individual dose factors for four materials. We need to develop items B through G in order to do our EIS. Items H and I are more involved in the costs. We need to find out more information on the actual source inventory. That has not been well defined. We need to find out economic impacts that will be given to industry with this rulemaking. And as far as the issues papers is concerned we're getting that out for public comment next month, and I already discussed the public workshops. It's also important for you to understand what the staff is involved in amongst other Federal agencies. I alluded to work with the EPA, but we're also working with the Department of Energy and other Federal agencies on the Interagency Steering Committee on Radiation Standards. We recently had a subcommittee meeting in February where we talked about our rulemaking efforts and other work that's being done in the Federal Government in this area. There is a Department of State initiative called the International Radioactive Source Management Initiative. It is something that is fairly recent in its development. We have many different Federal agencies participating on that initiative, private industry, we have the Conference of Radiation Program Control Directors, and the focus is not only on clearance, but it's on source tracking internationally. The NMSS and research staff have also been participating internationally with meetings at the IAEA, and we have one group of people going from the EPA, NRC, and DOE over to Vienna next month to work on one of the technical basis documents called Tech Doc 855. So the staff is quite busy in this area. That concludes my presentation. DR. GARRICK: Further comments? DR. WYMER: Yes. I am glad to see you working on this. I think it is an extremely important issue and I think there are hundreds of millions of dollars at stake here, depending on how this thing comes out. I had one specific question. It seems to me, I am sure you have good reasons, that you are limiting yourself quite a bit when you talk only about ferrous metals, aluminum, copper and concrete. I suggest that maybe you might want to consider the strategic and critical materials list that the Department of Commerce puts out, since these are strategic and critical materials, and they have a definite definition of what those terms mean. So it seems to me that this rule will be applied broadly eventually. No matter how you initially decide you are going to direct it, it will be applied as broadly as people choose to apply it. So I have that one comment specifically. MR. CARDILE: Yeah, I think -- and that is one of the questions in the issues paper. It lays out the material or the equipment and material we have information about now, the database we have now, and then it requests, well, what other suggestions are there for materials? And we would certainly take that under advisement. DR. WYMER: Any other comments? DR. HORNBERGER: Yes. Can you give me an idea -- you say are going to develop a dose based regulation considering from background up to 10 millirem. Why 10? Why not 100? MR. CARDILE: I will start and then you can jump in. MR. HUFFERT: Sure. MR. CARDILE: Well, it lays those I guess three or four as what we think are probably potential alternatives. The opening paper, for the cleanup rule, started at 100 and suggested 100, 25, you know, 15, 10, 1 down to background, and we wound up having a dose standard of 25 millirem for the cleanup rule for a land and structure based on, to some extent, on the fraction of 100 millirem as the appropriate value. The initial thought in preparing this paper is that, because, potentially, these materials can be more dispersed in the public usage than perhaps one fixed decommissioning site, or decommissioned site, that a value less than the 25 millirem from the cleanup rule was probably more appropriate here. Numbers that have been, you know, used or talked about in international circles, for example, for clearance, have been the range of 1 to 3 millirem, so at least as an opening suggestion here, we listed 10. Again, the question in the issues paper, are these appropriate values or not? DR. HORNBERGER: So sort of your rationale is that because these would be sources that could move around, that they would somehow be potentially more dangerous than a source that was fixed? MR. CARDILE: Well, not more dangerous, but perhaps a person could be exposed, whereas, a person would not likely be exposed -- well, not more likely. The dose calculation coming up with the 25 millirem for a decommissioned site is a person, a resident farmer or a resident person living or working at that site. That is kind of the limit as to what they would get. Whereas, here, it is not that it is more dangerous, but there is potential for, I guess, more multiple exposures in that -- DR. HORNBERGER: So it is a collective dose argument rather than an individual dose? MR. CARDILE: Well, it is also an individual dose argument to an individual, if we have to watch that you don't get more than this dose level from a particular -- that you can't get exposed to several pieces of equipment, or former pieces of equipment -- DR. HORNBERGER: If steel goes into a car and you drive around a car for your life, and that is worse than being a farmer living at the site? MR. CARDILE: No, but the steel could go into the car, and, you know, the material building your house, and the material, you know, in your car, your bed frame or whatever, things like that. DR. HORNBERGER: Has anyone worked out the probabilities that those multiple things would happen? MR. HUFFERT: Actually, that is one of the things that is going to be looked at in our statement of work for the continuation of the NUREG-1640 work. We are looking at exposures to multiple sources and population behaviors. That has not been done so far, and it is going to be a large piece of work to get that accomplished. DR. GARRICK: Have you done the cost -- implementation cost studies as a function of different standards, different clearances? MR. HUFFERT: We will be working on that. How we did it for the decommissioning rule was we chose different dose levels and we then took the dose levels, converted it to picocuries per gram by using a dose conversion factor, and once we had these levels of radioactive contamination present, we then did studies to figure out what is the cost of surveying to different dose levels. We would just take different concentration values. We set up studies where we would use very crude instrumentation, all the way to extremely sophisticated methods that are almost impracticable to use to try to figure out where the state of the art was. And from there, we basically came up with cost curves, and we could see where certain radionuclides were very difficult to measure and it helped us in our generic Environmental Impact Statement. And a similar thing would be done here for this rulemaking. The statement of work that I have been working on with the Office of Research has that stipulated, that we would go from a return to background or background level, all the way up to 10 millirem or more. We think we have a handle on what the dose conversion factors are from NUREG-1640 and other work done by the federal agencies, so we can start applying that work -- I'm sorry, those dose conversion factors to our study. DR. GARRICK: What about pilot applications as a rule, is this planned? MR. HUFFERT: As far as implementation? DR. GARRICK: Yes. MR. HUFFERT: That is in the statement of work. DR. GARRICK: Yes. MR. HUFFERT: Not to sound like a broken record here, but when we did this work for the decommissioning rule, we did pilot studies at large decommissioning sites. We also set up a maze, if you want to call it, at one of the national labs, work surveyors were required to go in and survey against walls to find out how well they could detect different radioactivity levels, and that also helped us as a pilot to understand what -- how implementable our rule really was. And we are planning something similar to that here. DR. GARRICK: What have been the operators' reactions to the program you have made so far, the people that have the facilities? MR. HUFFERT: I haven't talked to anyone yet about that. I have talked to people in the Office of Nuclear Reactor Regulation about it, since they are the group regulating the reactors and they are on the working group, they are on the steering group, they haven't raised any concerns yet. We don't know where the dose standard is yet, it is an open book right now. If it is a higher level, it probably will not present a problem. If it is much lower, it would be more difficult to implement. DR. WYMER: How much attention are you paying to the international standards in this area? They have already gone through this, at least some of the countries, and they have established standards, and they have methodologies established. How much are you taking that into account? MR. HUFFERT: The Office of Research -- in fact the technical manager for NUREG-1640 is a member of the working group who's developing Tech Doc 855. He'll be going there next month to refine that document further. He has been a very good resource for the agency, and we are kept aware of what's going on through him, and also our Office of International Programs. As far as implementation is concerned, I can talk to that a little bit, if that would help. There are studies going on internationally in this area not specifically related to clearance, but illicit trafficking, and for example there's a study being conducted right now at the IAEA that is -- they have set up a portable monitor at one of the -- I think at the Austrian borders. They are evaluating instruments from France, Germany, the United States, England, I think Sweden. They're evaluating the ability of these equipments to detect radioactivity in scrap or some type of confined geometry. There will be a workshop next month at Los Alamos on this, and I can tell you I just recently participated in a workshop with the steel industry on detection of radioactivity in scrap which will actually be very close linked to what we're doing here. DR. WYMER: Fine. Thanks. DR. GARRICK: I take it that this is a status report, that you're not looking for anything specifically from us except the discussion. MR. CARDILE: That's right, and as I pointed out, a good time to -- we'd be interested in -- the point of the issues paper and the public meeting is to get feedback to feed into some of these contracts as we go forward. And we'll be reporting back to the Commission in hopefully February of next year based on the results of all of these public meetings. So a good time to get some strong feedback would be in amongst the public meetings that we're holding in the fall, either while we -- or, you know, during that period of time or maybe immediately after that time we'll probably be in a position to report back some preliminary results about the meetings and also receive your input. DR. GARRICK: I guess that the real key here is that not as what you end up with is the actual clearance limits, clearance level. Is that right? And so the process by which you get to those levels. And you say that those have not really been established yet. MR. CARDILE: The clearance levels? DR. GARRICK: Yes. MR. HUFFERT: No, not at all. MR. CARDILE: Well, I'm sorry, yes, the process for us doing this rulemaking has been laid out, and it's laid out in management directives, in our regulations, et cetera. But as far as what the actual value is going to be, no, we don't have -- we don't know if it's going to be 10 or 100 millirem or zero. DR. GARRICK: Now are you satisfied that the way you're proceeding that everybody that has involvement in this process, the stakeholders, the public, et cetera, are in a position to contribute information for you to make -- for that decision to be made? I'm always thinking a little bit about the smaller operators who don't always have the resources to handle these kind of projects. MR. HUFFERT: I can tell you that when we do an analysis we're required in our regulations to look at the economic impact of a proposed rule on small entities under the Regulatory Flexibility Act, we need to do that. DR. GARRICK: Um-hum. MR. HUFFERT: And as Frank had mentioned, we are actively involved with the States in our working group and steering group, and certainly the public meetings, the Federal Register notices, we're going to have a Web site set up for comments on this. We're asking for a lot of public participation. MR. CARDILE: I expect that one of the participants in the public meetings will be, for example, the scrap dealers or the steel manufacturers, and they'll come back to us with a lot of information about what's practical and not practical, what impact this could have on their industry and not. With regard to -- that will represent both the large and small people who will be receiving this material. In terms of the large and small NRC licensees, that'll be -- I presume that'll be part of what we're getting at with some of these contracts that you do on survey abilities and capabilities and what are the costs to survey material, whether it's a reactor licensee or a small hospital. So -- DR. GARRICK: What do you consider to be the most difficult technical issue? Is it the surveying part of the problem? When you're dealing with these low levels? MR. HUFFERT: I think it's going to be a tremendous technical challenge if we are required to go to zero. [Laughter.] I don't mean to be facetious, but if you're at 10 millirem per year, it's a much easier target, but if you're at a small fraction of 1, it could be very difficult now. Maybe we can come up with some innovative methods of surveying. I don't know yet. DR. WYMER: In inferred, perhaps wrongly, from something that was said, that maybe you'll be making these permissible doses on these various kinds of materials radioisotope-specific with respect to the contaminant, and in particular with respect to the half-life of the contaminant, since obviously if it's a short half-life, it's not so important that it have a low a dose, because after a little while you won't have so much. Is that in there, or did I read something more into it than you said? MR. HUFFERT: Go ahead. MR. CARDILE: I'm going to let you answer. I was just going to say one point I may have made which may have been confusing was that, for example, a restricted use might be something that's beneficial where a half-life -- an isotope had a short half-life because obviously it goes away. I don't think we're planning on setting a dose limit based on -- DR. WYMER: On specific -- MR. CARDILE: Specific isotope. DR. FAIRHURST: How will you know where to look for this? I mean, there's certain pathways you can follow, you know, where something started out, but you're talking about scrap yards and things like this. How would you -- were you going to have a blanket requirement on all scrap dealers that they must check? Or am I -- MR. CARDILE: Are you talking about in general or about this restricted use possibility? MR. HUFFERT: The surveys would be conducted at the point of release of the nuclear facility. DR. FAIRHURST: Okay. MR. HUFFERT: I think before the material was released from the nuclear facility, you'd have to survey it, assay it, whatever, before it gets out -- DR. FAIRHURST: All right. MR. HUFFERT: To the general public. MR. CARDILE: But once it was released -- once it was surveyed at that point and released for unrestricted use -- DR. FAIRHURST: Then you don't worry about it. MR. CARDILE: It can go anywhere, and the hope is that these dose models that have been done in NUREG-1640 would sufficiently represent these pathways. DR. FAIRHURST: There's no need for concern? MR. CARDILE: Yes. DR. FAIRHURST: I don't -- MR. CARDILE: And that's why the restricted use is in -- because it says that while if it's decided that -- to limit where this material can go, then you have questions of well, how do you do that? And it's something we'll have to face. DR. FAIRHURST: Is this an issue that when you're talking about public meetings that there will be a broad spectrum of public involved or just people who feel like have some sort of business or -- a business reason for -- MR. CARDILE: Well, I think, as I was saying, there would be the nuclear industry or the licensed industry, not just sometimes when we talk about nuclear we think about, you know, power reactors, but it would be the whole licensed community. I mean, people from small walks of life with regard to licensees. It would also be the people who then receive the material, they have a business interest, but they also have a from what we've heard somewhat they also have an interest in terms of we're a steel manufacturer or where a scrap dealer, and we either can or can't deal with this material. So there would be that spectrum of people. But then there would also be -- and I think that's the process of the facilitator is to go get other, you know, public groups to say we're concerned or not concerned about this material coming into general commerce or general public consumer use, and if it does, what are the dose levels and that type of thing. So the hope is that the facilitator sets up these meetings so we get kind of people along this step of this process of where this material could wind up. MR. LARSON: Is your question in some of the past participatory rulemakings, you know, the agency has provided funds to some people that are unable to get to the thing otherwise. Are there plans in this one to do that? Is that what you're asking, Charlie? Like the Native Americans -- DR. FAIRHURST: What I'm trying to say well, if you have to go down to one millirem, or .1, it would seem to me that you're going to have a lot of pressure in any public meeting to keep going lower and lower and lower, and at some point you have to say look, this doesn't make either risk sense or financial sense or whatever. I don't know. I just -- MR. CARDILE: Well, one of the things that -- well, one of the things that the issues paper points out that the public meetings are intended to foster discussion, obtain advice, obtain data or information, perhaps not to reach -- and point out things like competing impacts, point out things like implementation problems like going to zero, but not necessarily to reach consensus. So -- MR. HUFFERT: That analysis will be performed in our generic environmental impact statement and regulatory analysis. There's a process set up for weighing the different factors. MR. LARSON: If a clearance level is for unrestricted use, then why are you going to go through a collective dose analysis, which sort of amplifies the situation that -- I don't understand. MR. CARDILE: I can start. Again, for example, these cleanup rules, for example, we went through a process of saying all right, well here's the exposure to an individual, but, you know, on the other hand, especially in the case of clearance, you might, while the exposure to an individual may be low, the exposure to a large number of people because there's a lot of equipment available could be higher. The guidelines of NUREG or BRO-058 in complying with the cost-benefit regulatory analysis guidelines talk about balancing costs and impacts. So we'll be looking at both individual dose and collective doses. DR. GARRICK: That likely introduces -- doesn't that introduce a real complication as far as accountability is concerned? MR. HUFFERT: What do you mean by accountability? Do you mean as far as defining the population? DR. GARRICK: Yes. MR. HUFFERT: Yes. I think that what would happen is we would have to give it our best shot of not only understanding population behavior, but also try to estimate the uncertainty in those numbers. And when we are collective doses, I think we should be checking the uncertainty in those numbers carefully. And if we follow NCRP 121 we would be categorizing our uncertainty estimates for the collective dose. MR. CARDILE: An additional uncertainty in trying to estimate collective doses is, if you are just calculating individual dose, you just need to know if such-and-such concentration gives you such-and-such individual dose. In order to calculate collective dose, we have to go back and make some estimate as what is the volume of metal at a power plant available at these levels. And that is something that is going to be part of these contracts, but it is not easy to put a handle on. DR. GARRICK: It sounds like a nightmare to me. Doesn't this run the potential of forcing you into the equivalent on an individual dose that is -- DR. HORNBERGER: Minuscule. DR. GARRICK: -- minuscule and infinitesimally small? Isn't there an allocation problem here of great proportion? MR. CARDILE: Well, an experience we had in -- I keep referring to the cleanup rule, but an experience we had in the cleanup rule was that we tried to do the same thing. We looked at, what is the collective dose from people either coming on and using these structures or lands for different possible uses down the road? That was a little easier because there is perhaps a limited number of ways you can use a building. But we actually looked at the building and said, all right, this building could be used for a certain type of usage, and the lands, or it could be used for an apartment building, you know, where there is a lot of people, but a lower dose because you only -- you know, there is a limited number -- a limited amount of usage of the land, as compared to, say, a resident farmer who is growing the crops. So we tried to look at alternate collective doses, and we had several different alternatives. And what we -- if you go back to the statement of considerations for the final cleanup rule or decommissioning rule, we, in essence, said that, look, there is not an absolute -- I forget the word we used, but there is not an absolute, definitive answer with regard to where the best ALARA number or the best cost benefit number is. It can vary, you know, based on the circumstance, based on uncertainty. The cleanup rule wound up saying we think that 25 millirem is the right fraction of 100 millirem. We think that this is sufficiently supported by the regulatory an and collective dose analysis that we think this is the appropriate number. So that is a long way around answering your question that, you know, in that case, we basically looked at the individual dose and said we think this is the appropriate number. We looked at the regulatory analysis and balancing of collective doses and benefits, or costs and that said that, you know, we can't make the decision based on that. We think we are right here with the right number. The same thing could happen here. We could decide upon an individual dose that we think is an appropriate constraint below 100 millirem, an appropriate fraction of 100 millirem. We could look at the collective -- we could say that implementation-wise, you know, you can measure this in a reasonable way. And with regard to the collective dose, given all the uncertainties of quantity of metal, following people around, how they might use this material, that, you know, that we think whatever this individual dose value we have set is reasonable. So that's two years ahead of where we are right now, but -- DR. GARRICK: It seems that we work very hard to make this as complicated as it can be. MR. CARDILE: Well, of course, we are required, as Tony's slide points out, to do a NEPA analysis, to do a regulatory analysis using the guidelines of the NUREGs. MS. THOMAS: Wait, wait. If you are not going to account for the material once it gets released for unrestricted use, how are you going to determine collective dose? That just doesn't -- it doesn't follow. MR. CARDILE: Well, we are going -- MR. GNUGNOLI: I think you have it just backwards. What we have to do is decide what criterion we will use. In order to see the cost benefit of using the different criteria to set clearance, we have to sort of know what the cost is going to be, both in terms of health effects and in terms of the commercial impacts and such. And, so, sort of the other way in that. Once we have set the clearance criterion and everybody accepts it, who cares what happens with all that? You know, at this point we are taking the lead from other organizations who have gone a little bit ahead of us, like IAEA, where they have tied it traditionally to the idea of trivial dose, which is the 1 to 10 millirem range from Safety Series 89. And that is basically why it factored into our range of numbers that we selected for the dose considerations. And then other people will say the difference between 10 millirem and 30 millirem is really inconsequential. So the idea is perhaps in that range, we will cover enough that it might be below, let's say, the D and D standard of 25, that we have, in effect, tried to cover the spectrum a little bit at the lower end. DR. GARRICK: So given what we have heard from the health physics experts about the effectiveness of 100 millirem standard as assuring the protection of the public, given that kind of information, what is your view with respect to risk and safety if we eliminated the collective dose requirement in the rule? MR. CARDILE: We are not anticipating having a collective dose requirement in the rule, of course. I mean we are only using it as a tool. The rule would be -- DR. GARRICK: Well, to calculate the dose. Yes. DR. FAIRHURST: What is the basis for the IAEA 1 to 10 as being trivial, is that -- MR. GNUGNOLI: It is out of Safety Series 89. They went into it to some degree -- there is a discussion in Safety Series 89 on setting that. DR. FAIRHURST: No, but I mean was that based on sort of idea that a collective dose, no matter whatever material it was, you could never do any harm with 10 millirem? MR. GNUGNOLI: I really don't remember. DR. FAIRHURST: Or did you just pluck it out of the air? MR. GNUGNOLI: Actually, it would have been a number of experts plucking it out of the air, that's the way they work. DR. FAIRHURST: I think most people would agree that 10 is trivial. MR. GNUGNOLI: Right. DR. FAIRHURST: That doesn't mean that 10 is a justifiable number. MR. GNUGNOLI: Well, the idea -- I don't doubt that there are practices and activities with higher possible dose levels that would be okay. The idea over this triviality aspect is it would be applied across the board to any activities so you wouldn't have to think about it. DR. FAIRHURST: Right. I understand. MR. GNUGNOLI: But in things above those levels, it may still be perfectly safe, but they would have to be looked at site-specifically. DR. FAIRHURST: It is like shooting yourself in the foot. MR. GNUGNOLI: Yes. DR. GARRICK: One of the things that I think that is a hopeful advantage of a risk-informed approach to regulatory practice is simplification, is, you know, the idea of getting away from subsystems requirements over prescriptive, intermediate results, et cetera. So that is an aspect that we are looking for. One of the things I was curious about here is, given that you have guidance from the commission level with respect to regulations and the development of new regulations to adopt a risk-informed, performance-based perspective, what have you done here to do that? As best I can tell, the only thing you have done is the so-called probabilistic exposure scenarios. Is that it? MR. CARDILE: I guess -- don't forget, we are at the very early stages. DR. GARRICK: Yes. MR. CARDILE: As Tony mentioned, we are planning on making sure that this thing is implementable, any dose level we pick is implementable. The other thing is we are looking at what is the appropriate individual dose level, what is the appropriate risk that we are looking at here. So, I think, you know, obviously, this rule is going to be based on both the risk to an individual and the ability -- the capability to implement whatever rulemaking we come up with. DR. WYMER: I have a -- MR. CARDILE: But we may be -- I'm sorry, I didn't mean to cut you off. DR. WYMER: Go ahead. MR. CARDILE: I was just going to say that that is the idea, the point of the issues paper is to say, is this the appropriate set of factors to be using in the consideration of setting the standard? DR. GARRICK: Yes. MR. CARDILE: I mean here is alternative dose standards which we could use, here are some of the factors that we would consider in developing them, namely, health and environmental impacts, cost benefit implementation, other countries' standards. What guidelines would you give, you know, the collective you, as we proceed? The point of the issues paper is to foster this kind of discussion, but we don't have the answers to these questions. We're trying to formulate what our questions that we can go to the public with and -- both the general public and the regulated public and the steel manufacturer public would, you know, wherever they fit in the spectrum and talk about these kinds of questions. DR. GARRICK: Yes. Well, we sort of believe, I think, as a committee, that the strategy with respect to regulatory development, if indeed you're going to go in the direction of risk-informed performance-based, is to make them very tough with respect to performance and risk requirements, but allow a lot of flexibility with respect to how you get there, and move away from overprescriptiveness of the intermediate steps. And I take it that's what you're trying to do with a dose-based approach. MR. CARDILE: Definitely. I think, for example, if you go back to the cleanup rule, it's fairly unprescriptive in the sense that it lists a dose standard. DR. GARRICK: Right. MR. CARDILE: And that's basically it. DR. GARRICK: But I'm a little worried about this issue of what you end up with as dose levels, number 1, and how that is allocated, number 2. MR. LARSON: Are you alluding then that you'd like to see the issues paper and the technical basis document rather than towards October and November, sooner than that? Because supposedly a technical basis doc can be out -- you're saying June, right? And of course the SECY says the issues paper was out in January, but it still hasn't got out yet. MR. CARDILE: No, the issues paper said that it would be sent to the Commission in March, and that's what we're planning on doing, and then we will publish it in April for comment until November. The NUREG-1640 is scheduled for publication in March. DR. WYMER: Yes, that sort of gets at what is the extent of the responsibility of the Nuclear Regulatory Commission in these kinds of matters. In a way it gets at that. It also relates in a way to two points I raised earlier on strategic and critical materials and whether or not you're radioisotope-specific in this thing. Although I kind of inverted the last one now, and I'll say what materials are you going to pay particular attention to, if any, and let me tell you what I mean when I ask that. I'll give you a trivial example, but there probably are better examples. I know, for example, that there was a great deal of concern in the people doing very-low-level background counting that we don't crud up the copper that's used in the instrumentation, and there are probably other similar examples that can be found in specialty uses of materials that might be contaminated with low levels of radioactivity that would be deleterious to scientific investigations or health studies or things like this. So are you going to try to pick out, you probably are not, but pick out specific materials that have known specific sensitive uses, uses that are sensitive to radioactive contamination and put them into a special class with special requirements? MR. HUFFERT: No, not to my knowledge. DR. WYMER: The answer is no, huh? MR. HUFFERT: So far what we're doing -- DR. GARRICK: Simple answer to a long question. DR. WYMER: Yes. MR. HUFFERT: We are focusing on copper, aluminum, iron, concrete. That's what was done. We will be including soils at the Commission direction. And for this proposed rulemaking, I don't think we're going to be including any more materials unless we're directed otherwise. It's one of the issues that are contained in the issues paper, should we be doing this. So -- DR. WYMER: Copper of course is one of the -- MR. HUFFERT: Right. DR. WYMER: Sensitive materials. DR. GARRICK: I guess one of the things that would help the committee a great deal on this whole issue is to get a better sense of the world into which this thing is going to be applied, because it would be easier for us to visualize what kind of problems might develop if we better understood the variety and spectrum of applications in the kinds of facilities you're talking about and the size, shape, et cetera. I'm sure we can dig that out, but I think that it's important to understand the operational implications when you're looking at any kind of future development of regulations. That's why we ask the questions about participation, who participated in developing source material that you use to move forward with the documentation. I don't know whether it's practical for us to at some point in time get a little better overview of how this thing is going to be used or not, Howard. DR. GARRICK: I think -- part of my concern about a lot of these things is I think we sometimes -- the committees are handicapped unless they're really operationally involved and can get overacademic about their consideration of some of these things, and I think we need to be a little educated on the field and what's going on out there in order to better visualize some of the problems that you might run into. I don't know if that makes any sense to any of my colleagues or not. DR. WYMER: I don't mind being called academic. DR. HORNBERGER: Howard can brief us. MR. GNUGNOLI: One of the things that really wasn't discussed a whole lot is the fact that the United States may be faced in the future with importation of materials, and there's very close work with the State Department on that. There's -- we are aware that perhaps the extent that you are addressing can be described as pervasive. It's almost in every -- DR. GARRICK: Yes. MR. GNUGNOLI: You know, aspect of our society, and maybe we're putting too much stock in this enhanced participatory rulemaking process. But it is our hope that we will glean more and more of a picture as time goes on with people telling us you don't have the idea of what's going on, what about this and this and this? DR. GARRICK: Yes, one of the bodies that I like to hear from of course are the people that are going to be affected by this. MR. GNUGNOLI: Did you say infected? DR. GARRICK: Affected, and particularly because the standards seem to be very, very low that we're talking about, and it's not clear that there's much anxiety here as far as health and safety is concerned. But I think the view of the licensees that have to live under these rules is very important for us to also hear. Because they can speak the kinds of problems that I am alluding to with direct experience, and that as background information has always been very helpful, to me, anyhow, in offering any kind of advice on these kind of issues. MR. CARDILE: I am sure that with regard to the licensees who are going to have to face these dose levels, that they will be well represented at these public meetings. DR. GARRICK: yes. MR. CARDILE: And also from the experience of the cleanup rule, I am sure we will get plenty of letters or comments. DR. GARRICK: Yes. MR. CARDILE: Written comments on whatever stage we are in, including I am sure when the issues paper goes on the streets, we will get some written reaction from the nuclear industry, the NEI, you know, the various industries saying we have no material, this is a waste of time. These doses you are talking about are too low. We got -- you know, like I say, the cleanup rule, steps along the way generated quite a bit of information, you know, written letters to us letting us know what is reasonable, what is not reasonable. So that aspect, I have no -- that piece of the world, I have no doubt, will let us know what is going on. I also have no doubt that the steel, given what we have heard at a couple of meetings, that people who are going to be the immediate recipients of this material will let us know that these doses are too high or too low, or are going to cause havoc in their industry or not. And then I have no doubt that, you know, at least convening the process to get public involvement, you know, the general public, they will let us know whether they think these doses are too high or too low. That was certainly our experience in the cleanup rule, and I expect that this facilitator for this rule, both the internal -- well, I can't speak to the external facilitator, but the internal facilitator for the cleanup rule is the same person who worked on the -- for this rule is the same one who worked on the cleanup rule and is familiar with the parties and how to get representation of the different parties and how to bring that, you know, their views forward, so we should be pretty well served. In terms of looking at trying to give you better information about what is the universe of materials out there, and the situation out there, there was -- an earlier draft of this NUREG-1640 had a discussion of a literature survey of materials that were covered, you know, that would be covered by something like this. I don't know if that was ever published, but I would suspect in succeeding documents that we are going to have that type of information available to you. DR. GARRICK: Okay. Any other comments from members, staff? [No response.] DR. GARRICK: We are grateful to your time management in allowing us plenty of time to ask the questions that we wanted, so we like that. Thank you very much. I think that completes this topic. MR. HUFFERT: Okay. Thank you. MR. CARDILE: Thank you. DR. GARRICK: Thank you. Okay. What I would like to do is maybe, given it is a long afternoon, is take -- rather than one 15 minute break, we may take two 10 minute breaks, and I would like to declare one right now, a 10 minute break. [Recess.] DR. GARRICK: We will come to order. We are now going to hear from Nick Orlando on the decommissioning standard review plan. MR. ORLANDO: Thank you, Dr. Garrick. What I would like to talk about today is just to give you all a little update on the standard review plan. I think the first time I talked to you about this was about six months ago, and in that discussion I showed you a schedule where we had incorporated some ACNW briefings and some requests for input, and this is actually the briefing or request for input that I was supposed to have for you a couple of months ago, but we have supplanted that with just an overall program presentation, so that is what I am here to talk to you about today. Just to give you a little bit of background information, remind everybody, back in July of '98, the commission gave the staff some direction to go forward with some guidance that the staff had put out, specifically the DG-4006, said send that out for a two-year comment period and maintain a dialogue with the public during the comment period, develop a standard review plan that incorporates the risk-informed iterative approach in NUREG-1549, and also provide clear guidance on what we mean by ALARA when we develop the SRP, review the potential conservatism in the D and D screening code, and test the D and D model on some sites and use that as a test bed for developing your standard review plan, and, finally, use the probabilistic approach in calculating the total effective dose equivalent to the average member of the critical group, which is the dose target in the new license termination rule. My little portion of that world is the development of the standard review plan. The purpose of the SRP is to allow the staff to evaluate information that is submitted by licensees, to support the decommissioning of their facilities. We want to be able to do this in a timely and efficient manner. We have had concerns from licensees that our reviews take too long and that they tend to be disjointed. We also have to make sure that the decommissioning can be conducted in accordance with all of our criteria and at the end of the day, the licensee will have submitted all the information the staff needs in order to make the judgments about the standard review plan. We had given you a description of the contents of the standard review plan. If you are familiar with NUREG-1199, where it talks about -- or where it sets out acceptance criteria, and resources, and analysis requirements and whatnot, the standard review plan will follow that same basic format and content. And then the very last bullet on the slide indicates that we will use this to review not only decommissioning plans but also other information. One of the things that has come up since we started developing this, at least from my perspective is the interplay of this with the activities in the Office of Nuclear Reactor Regulation. And I think because of the process we have been going through, and because of the discussions we have been having, that, at least for me, has gelled up very nicely and we can talk about that a little later on when I get to the question and answer period, so I will give you one question you can ask me. Okay. One of the things that the commission said to do is make sure that we continue having stakeholder input, and to do that the staff has and will continue to have a series of workshops on different aspects of the standard review plan. Now, we had the first workshop back in December, the 1st and 2nd, of last year, and in that workshop, we discussed specifically dose modeling. We had a second workshop in January and we talked about dose modeling and restricted use scenarios -- or license termination under restricted use. I recognize that these workshops are intended to facilitate a two-way dialogue between the NRC staff and licensees. They can raise issues to us, we can talk about them in an atmosphere of trying to figure out what the questions and the possible solutions are. We can't go to the licensees or to the participants in the workshops and ask them for solutions because we run afoul of FACA if we do that, the Federal Advisory Committee Act. So, in some of the workshops we have had a lot of data presentations. The last one, in particular, was extremely symposia-like, but everybody seemed to enjoy that. We talked a lot about some of the issues facing the dose modeling group. The last workshop in March was actually on dose modeling the first day and ALARA issues the second. The way we have set it up, at least the last three, one day was dose modeling and then the other day was another issue. In June we are going to have this third -- or the fourth workshop, and if you look at your old schedule, that was actually slated for I think the 18th and 19th. We got bumped because of the annual NRC awards ceremony, the Presidential awards, and so we had to move that back to the 23rd and 24th. And in that workshop, we are linking that to a workshop that Tom Nicholson and Research is having on groundwater, so there will be four days of groundwater modeling issues being discussed. The August workshop, we are going to talk about comments that we have received to date on the D and D screen, and either discuss surveys or discuss questions or issues that are identified by the agreement states. One of the persons who is -- or one of the participants in the workshop has been Dave Zamori from the New Jersey Department of Environmental Protection. He is representing the Council of Radiation Control Program Directors, and he has requested a day for the states to come in and present what they think the issues are and questions and problems they see having. So I am not sure if we are going to do that in August or October. Originally, we thought we would do it in October, but the agreement states are kind of indicating they would like to do it earlier as opposed to later. And then if we don't do agreement state issues in October, we will do surveys. Now, as far as some of the milestones -- DR. GARRICK: Are you going to tell us a little bit about what you have learned from the workshops? MR. ORLANDO: Well, one of the other handouts I gave you was a list of issues that had been identified. Some of those are issues that came out of the workshops. Some of those are staff generated issues. I can discuss a little bit about some of the observations I think that we saw in the workshops. DR. GARRICK: I am especially interested in anything that led to changes or revisions or anything that was significant enough that it changed your way of doing business. MR. ORLANDO: Okay. And to remind you, the milestones that we have established or set up so far, we are still on track pretty much. We have established the work groups. We have developed the default tables and published that in November of '98. And we have identified the issues needed to comply -- or to start developing the draft SRP modules. We still hope to finish development of the drafts by June and then close -- and then revise those by May of next year, and then submit the final draft SRP for review in the summer of 2000. We have had several challenges, as you may or may not be aware. Specifically, we lost some folks, Dave Fauver has moved on to private industry. He was one of the group leaders for the surveys module. He was also heavily involved in the dose modeling group. To offset that, we have contracted with the Oak Ridge Institute for Science and Education to help us develop the surveys component. In addition, Tim Harris is going to be working with the dose modeling group -- Tim Harris is in my section -- is going to be working with the dose modeling group to take up some of the work that Dave had been doing. Richard Tretill, who was originally slated to head up the group on financial assurance has rotated out, and I am not sure when he is going to come back, so we have asked ICF, Kaiser, who does a lot of our decommissioning, financial assurance reviews, to come in and write that portion of the standard review plan. It will be written by those folks but overseen by NRC folks. In addition, there have been some other staff moving around a little bit, but we think we can still catch up and get done what we need to get done. The -- let's see, I seem to have lost my issues one. The very last slide in your packet is a list of issues requiring resolution. Instead of taking all of the issues on the second handout and trying to make slides on them, what I thought I would do would be to give you those, let you look at them at your leisure. You can think about them. We can discuss a little bit some of the thoughts that I am having, or that some of the work groups are having. Bobby Eid is in the back -- or on the side. He can talk about some of the issues associated with dose modeling. I can talk about restricted use and some of the other modules. And, you know, we can talk about that a little bit if you would like, or we can just talk about the workshops, as you have indicated, or just about anything else. I just wanted to give you an update as to where we were with everything. We have met the milestone of identifying the issues and one of the things we said we were going to do when we did that was give them to you and let you all think about them, too. So that, believe it or not, concludes my formal presentation and maybe you will thank me, too, for giving you all kinds of time to ask questions now, till 5:30. MR. LARSON: You have prepared some answers that you have given in some of these public workshops to some of the questions on these issues. MR. ORLANDO: We have thought about some of the answers, yes. MR. LARSON: Well, I have been at some of them, and so has Dr. Wymer, where you have talked about -- you have given the questions in writing and given the answers orally. MR. ORLANDO: Verbally. MR. LARSON: But I mean you have got answers to some of these. MR. ORLANDO: Yes. MR. LARSON: So if the members had some questions, they could ask. MR. ORLANDO: Certainly. But, of course, you know, those are, as I said in those venues, those haven't been translated into actual draft standard review plan acceptance criteria or anything yet, they are just sort of the staff's working thoughts on a lot of them. DR. HORNBERGER: Which do you consider the most sticky wickets on this list of issues that is behind you? MR. ORLANDO: Dose modeling. DR. HORNBERGER: Dose modeling? MR. ORLANDO: Without a doubt. The most work, the most technical issues. Quite frankly, for health and safety plan surveys and financial assurance, I think, in general, those are going to be pretty easy to do. I mean it is just the process of writing down what we want. It is kind of interesting, for health and safety plans, there is guidance out there on what we want. There's a lot of health and safety plans that have been written. There are some very good health and safety plans. Financial assurance -- there's just so many things that we're going to accept: surety bonds, statements of intent by federal facilities, you know, external sinking funds, things like that. We don't have a whole lot of wiggle room. The regs are pretty clear. Dose modeling? You know, we have a code, and, you know, how are you going to move from specific -- excuse me -- from screening to site specific, how are you going to factor in these difficult cases, things like that. I'm writing a lot of the modules that aren't on here, for example, facility operating history, you know, things like that, and those you have to generate from whole cloth. But clearly from a technical standpoint, dose modeling is going to be the tough one. DR. HORNBERGER: I would be interested in hearing some more discussion about dose modeling, but before we do that, do you have a gut-level feeling about how you're going to handle ALARA? MR. ORLANDO: Chris McKinney unfortunately is not here, he's out in New Mexico today, but he has identified some of the issues. The principal issue with ALARA is making sure that it's an a priori kind of an assessment. There is a lot of concern -- ALARA can kind of be handled two ways. I mean, you know, sort of traditionally, you can look at it and say, well, here's my dose and that's the amount of material in the dirt or that I'm shooting for, and the dose I'm going to get from that, and if I clean up six more inches, how much is that going to cost and what's the dose benefit. There's also what Chris likes to think of as rolling ALARA assessments where you're doing those kinds of things as you're looking at imbedded pipe and as you're looking at each -- as you come across individual situations at the site, where perhaps you would maybe not have as good characterization as you need. So you start chasing contamination through the soil. Well, all of a sudden, you've got to start making ALARA assessments at that point, because if you thought it was going to take X amount of money to clean up to a certain level -- don't forget, ALARA is below 25, so we're already, you know, safe. If you wanted to take it to 23, all of a sudden, if you've got to dig 75 more feet or 75 more cubic feet of dirt out at a cost of a couple of thousand dollars a cubic foot, all of a sudden, you've got to start making ALARA assessments at that point, and those are the kinds of things that he's having -- wants to get, you know, down. MR. LARSON: Yes, but the SRM on ALARA said that in addition, if the licensee complies with the 25 millirem dose criterion using the screening, the licensee will emit the intended ALARA requirement and additional demonstrations may not be necessary. MR. ORLANDO: That's for soil. MR. LARSON: Okay. DR. HORNBERGER: But as far as the dose modeling goes, you're first overhead related to the D and D code and testing it at a complex site, et cetera, et cetera. MR. ORLANDO: Yes, sir. DR. HORNBERGER: Tell me a little about the dose modeling and to what extent does it cover what was on the first of your overheads and to what extent does it go beyond it for more complex sites. You mentioned site specific. How is this all going to play out? MR. ORLANDO: Okay. If I can, I would like to turn it over to Bob Eid. He's the project or the group leader for the dose modeling group. If that's all right with you all since he's the one who -- DR. GARRICK: Yes. I think that would be good. MR. EID: Good afternoon. My name is Bob Eid. I am here to answer your questions about dose modeling. I will try. As you know, dose modeling is very complex, lots of issues. We try to deal with the issues as much as we can. We try to interact with the users also to look into what are the issues that they face when trying to use the current tools that we have or the tools currently available for dose modeling. As you know, the current tools for dose modeling, most licensees, they use -- they have two options. They have the D&D version 1 code that we have, and this is the NRC code, and we said this is a screening code, it's for a two-year period. We found that also the license, mostly they use RESRAD. The licensees tend to use more RESRAD rather than D&D screen. Now, you asked the question about what are the issues in dose modeling. There are so many issues -- where to start? Let's first see, just to give you two or three or maybe four issues, for the current code that we have, version 1, we have the issue regarding alpha emitters for surface contamination. The alpha emitters for surface contamination, DCGL, those guidelines -- currently they are very low. They are not detected at all within the limit or with the fluctuational background. That's an issue. We struggled with that issue early in the process. We tried to generate default tables for licensees to use. We were successful in generating default tables on D&D version 1 for beta and gamma emitters, but we were unsuccessful in developing default tables for alpha emitters. That's the first issue. The second issue that we have about the methodology of D&D version 1.0, the methodology we tried to -- NMSS staff expressed their concern from the beginning that the current methodology tended to exaggerate or to be conservative, such that there would be a dose, higher dose that maybe is not needed -- in other words, to increase the risk -- and the answer was, well, this is screening methodology and we understood that. But I guess there were presentations also in this regard, and everybody understood yes, it is screening and we like to take it as screening methodology and we should accept that excessive dose. Now, working with the code, we found that from this workshop, they were very usual, that the licensees, they did use the code, and they came with numbers, and they found that for certain radionuclides, these doses, they are practically unacceptable for them, and they called them anomalies. An example for those, they are the cesium values and the strontium 90 values. To put you in perspective, if you are interested in knowing numbers, the current version 1.0 produces doses for unit concentration, one pico curie per gram, of about around 60 millirem per pico curie per gram. However, if we use, you know, the Sanuleta report where they listed single radionuclide source, they assume not all radionuclide source, all come back to the reason behind this extra dose, that it is -- you will find that the value could be 14 millirem for strontium 90. For cesium, the unit concentration dose currently in D&D version 1 would produce about 28 millirem, whereas in the report using single radionuclide value, would produce -- also be around fraction of millirem. So you could see the difference in the doses. The reason for having these extra doses currently, because the methodology tends to be over-conservative and tried to assume that you have all radionuclides listed in the table at your source. So in other words, just to articulate this, to be honest in my giving you the presentation to reflect also research point of view according to what they said, okay, these anomalies in the version 1.0 for some radionuclides -- again, not for all radionuclides -- they're related to the high dose values generated using version 1 as compared to using single radionuclide input, and they are called both artifact of the current methodology to select a solution representing the single default set for all radionuclides. That's what the have. And this is -- I guess it's a significant issue. The question, is this such kind of high difference in the dose, and everybody recognize that extra dose there is not needed, because at the end, you have a default parameter that's indeed for when you have all radionuclides to establish single set or default parameter for all radionuclides sources, you will end not with the 90th percentile of certain parameters, you will end with the 99.9 percentile of that parameter. So this is -- that's, you know, I think a serious thing that we need to consider, whether to -- you to accept whether the licensee can accept this extra dose between one millirem or 28 millirem or between 14 and 16 millirem or not. If we agree that it is not -- it is an excessive dose that is not needed, then maybe you will need to modify the methodology currently and D&D. The answer to the question of what to do about it already exists, and it was realized earlier that the -- possibly this excessive dose could be resolved by having the Monte Carlo version, where in the Monte Carlo version, you try to avoid -- you put your single radionuclide or the mixture of the radionuclides that you have and then develop default parameter, see if that corresponds to these kind of scores. So by doing this, you will minimize this kind of excessive dose that's currently in D&D version 1.0. Another third issue also, the input parameters in the current code, and we talked about it and we said this represents all kind of conditions across the United States, represents all radionuclides, and these input parameters, they are conservative somehow. We found there are certain parameters that are quite conservative. Almost there is consensus among the group that they need to be changed. An example of those is the mass loading factor for plant reposition, and this is a number almost everybody agreed that needs to be changed. Another factor which we spent lots of time in the discussion in the dose modeling group is the resuspension factor for indoor. The resuspension factor for indoor, we find the PDF is constructed on data which was taken in 1964, published data, and the number of data points here are two, although they were also data points for that specific reference that was quoted. We tried to look at the PDF again to look critically at what kind of data we have, and we find we understand that yes, it is conservative. We were at first with the situation, okay, what to do about it, what alternatives we have. We found that we need additional data. We tried to look at additional data, and the workshops, they were very successful trying to communicate with the industry and plead for them to give us whatever site-specific data they have. I would like to record that we were very successful on the one that -- the industry cooperated at the workshop. They were so successful in getting actual data that were measured over years by the licensee that they were not aware of, and there were several presentations about resuspension factors by industry. There were honest and true presentations by us and new suggestions. I think possibly, if -- still we are not in complete agreement within the group. If we agree, we have consensus agreement, we could move forward to modify resuspension factor. If we do that, based on our recommendation that not everybody agrees, of course -- as you know, this is technical discussion not everybody agrees on. If we move forward this that, we could modify the alpha surface contaminations by possibly a factor of 18 to 20, and we will be now in the working region, the measurable region of dose. Those are some of the issues. There are other issues that, you know, I would like to give you more time if you would like to ask any other questions. DR. HORNBERGER: Just a short follow up perhaps. What you've described, you're right, I mean, these are interesting technical issues. It appears to me that you have your ideas well in hand for how you're going to collect data and perhaps modify the code and change default settings. In other words, you've given us a good indication that you have the road pretty clearly mapped out in front of you as to how you're going to solve these technical problems. Do you see any technical problems din the dose modeling that you don't have a clear idea of how you're going -- that is, are there some big questions that really aren't even resolved conceptually? MR. EID: Really, I do not know specifically. The only problems that I know, that the licensees are using one code and we have another code, and we are trying to use and to improve our code as much as we can to make it more useful for screening. Our code has limitation, as I said before, and we tried to balance to see what are the limitations and to what extent we can use our code, and to what extent that we could allow the licensees to use our other codes and how we evaluate that. We found that RESRAD, as you know, is a very popular code used by the licensees. Now the question is, when the licensees, they submit RESRAD to us, we have no information about how to assist the conservatism in RESRAD, how to assist these parameters. We are working on that. But also, we need to start with this -- the Commission, they told us to have risk-informed, you know, based regulations, so try to look at RESRAD, and currently it's more deterministic. They are working on a probablistic version, which is not workable. So that's the reason we tried to develop -- we developed a scope of work for RESRAD, a RESRAD probablistic, and we tried to have some kind of similar approach which we adopted, actually, the probabilistic approach. That's one of the issues that we struggled at the beginning, to go to probabilistic or deterministic. We agreed that we would like to go to the probabilistic, although we cannot completely say, if licensees submitted deterministic with sufficient justification, just ignore it completely, but we've said that's the route we'd like to see. Therefore, we are working on it such that if licensees, they submitted RESRAD for site-specific analysis so we could have a feeling and we could have the tool to assist what kind of conservative assumption they have. The question is, can you use other codes for screening analysis. Then the issue will be, you have two default values, for example, and how you deal with that. I think if we succeed in modifying our code currently and we have trust that yes, the numbers are workable, they are good and they are prudently conservative rather than excessively conservative, I could say that it is a step forward. Possibly we may find out that there are some comparable results between -- if we have probabilistic RESRAD -- between RESRAD and D&D. So if we do that and they are comparable within, say, 10, 20 percent, I mean, okay, we will accept that. We could say you could use any code even for screening. But currently, because we do not have sufficient confidence in the level of uncertainty and confidence in the dose levels that are derived, we say we will use D&D screen for screening. However, for site specific, the licensees could use any other code, but they have to do, you know, the uncertainties and additional justification based on site-specific conditions. DR. GARRICK: Can you say a few things about what you're actually doing to make the analysis probabilistic? MR. EID: Yes. What we are doing, already, as you know, D&D is a -- it is originally probabilistic but currently version 1, it is not probabilistic, it is deterministic, because the input parameters, they are single default data, they are inputted in the code. So the PDFs for the different parameters were selected based on probabilistic approach; however, they are single values currently in version 1. But we are doing work -- I guess there was a previous presentation by Research about developing a Monte Carlo version of D&D. It's called version 2.0. So we are hoping this version will be accessible to use by the staff and the licensee as soon as possible. Our information, that this will be within six to nine months, that would be produced assuming that the contract is placed. DR. GARRICK: How are you going to obtain the PDF input parameters? MR. EID: For RESRAD or D&D or -- DR. GARRICK: D&D, yes. MR. EID: For D&D, already there are PDFs, but they were used for, you know, at the beginning, to start with, for singular radionuclides. And then we tried to generate PDFs by having mixing those -- all of these radionuclides, mixing them together. I tried to generate a dose which is, say, the 90th percentile of the dose based on those PDFs. So the version -- this is version one. version two will try to input the PDFs that they could respond to that radionuclide mixture or to that specific radionuclide. For example, currently, the code will assume all radionuclides that you have there and will try to modify those PDFs slightly in order to accommodate the 90th percentile level confidence for all radionuclides, regardless whether it does exist or does not exist. The version two, it will only account for the PDS that correspond only to the radionuclide present at the specific site. DR. GARRICK: So is that how you deal with the site specificity? MR. EID: Right. DR. GARRICK: Because the screening -- when it's screening, it's really not probabilistic because it's a table of PDFs, right? MR. EID: That's correct. DR. GARRICK: All right. MR. EID: That's correct. So hopefully, possibly if we find that -- from Monte Carlo version, we may look at, say, fuel cycle facilities, they have specific radionuclides, could be five, six or ten radionuclides, so you run the code and see those correspond to this kind of source term; or if you have a nuclear power generator facility that has a specific source term, you only consider radionuclides for that specific source, you do not need to consider other kinds of radionuclides, that they may be an outlier causing the dose to be very high. DR. GARRICK: Yes. Ray? DR. WYMER: Well, I did attend the January working group meeting, and I thought there was a lot of good interplay between the industry and the staff and found a lot of receptiveness in the staff to the ideas that the industry came out with. One thing that struck me, however, was that there seemed to be, at least among a few of the industry people who stood up and talked, a strong tide running for why we're fooling around with D&D when we've got RESRAD, we know it works, we've been using, we're happy with it, we've got experienced people with it. So we're still in that sort of dilemma of having two different approaches. What can you say about that now, Nick? MR. ORLANDO: Well, I'll say what Cheryl Trottier said at the last workshop whenever a question was asked, and that's that D&D was an NRC staff code, it was developed, and it was -- since we had it, it was put on the street for use. I think Bobby indicated that, you know, it's appropriate for screening right now, and that if licensees want to use that or RESRAD, they can come in and just negotiate with the staff on which one they're going to use. DR. WYMER: I have a recollection that the two codes didn't always come up with the same answer for the same situation. MR. ORLANDO: And I think that's one of the things the dose modeling group is looking at, is trying to make sure that, you know, when the program version comes out or other versions of RESRAD come out or the input parameters that would go into the RESRAD, the doses will be coming out closer or, you know, within -- DR. WYMER: Within acceptable -- MR. ORLANDO: Within an acceptable range, I should say. MR. NELSON: This is Bob Nelson from Division of Waste Management. I would like to address that question, RESRAD versus D&D. We've said this several times during the workshops and it's important to stress that D&D was only intended originally as a screening code. Because it was intended as a screening code, the default parameters set were set at a very high confidence level to achieve -- so that you would achieve a 25 millirem dose, and they were set based on probability distributions of the various input parameters, and because it was a screening code, the ultimate numbers were chosen, had to consider already nuclides. So regardless of what radionuclide you put into the code, you're going to come up -- the default parameters stay the same. That's one of the problems with using it in a site-specific way that Bobby has talked about. The RESRAD -- the basic difference between RESRAD -- one of the basic differences between the two codes is the defaults that are used. They were not determined the same way. The default parameters for RESRAD were determined deterministically based on expert judgment. So one of the things that we are doing is developing under a contract -- Mark, maybe you can -- with Argonne to develop a same type of probabilistic default parameter set for RESRAD as was developed for D&D so that we have basically an apples and apples comparison rather than an apples and oranges comparison. I think that will eliminate some of the confusion between the two codes. As Bobby talked about, we're developing the Monte Carlo front end to D&D to eliminate this problem of not being able to look at specific radionuclides and getting a more realistic dose out of the code. Both of these, of course, require time to implement. The D&D Monte Carlo version won't be even at a beta -- test version won't be ready until, right, nine months, sometime in the Fall, and a final version won't be out until about a year from now. So we have this interim period where we still have what we've got. DR. WYMER: How will it impact your two-year let's-see-what-it-does period? MR. ORLANDO: That two-year is -- that's for the dose -- the draft guidance GG-4006. That was put out, and the comment period on that closes this year, August of this year. DR. WYMER: But the trial runs will be done with the existing version. MR. ORLANDO: I guess what I'm saying is there was no Commission-directed two-year time frame for evaluating the code. DR. WYMER: Okay. MR. NELSON: One other point I wanted to make, that even once we have these -- so we are on a path to getting better -- code working tools out there, but we still have another issue with the codes. Once -- even if you have these probabilistic determined defaults in both codes that are similar, how do you change to go from a -- the default to a site-specific parameter? And if you change one parameter, how does that impact the other parameters? What linkages are there and what other parameters do you have to consider when you consider changing a parameter? That's another issue that the dose modelling working group will be addressing during this development period, and some of the guidance we're going to have to put out is how do you change default parameters, what justification do you have to supply to change from default parameters to site-specific parameters. DR. WYMER: That does a good job of answering my question. DR. GARRICK: I guess I'm still struggling a little bit with the merit of a Monte Carlo calculation at the screening level where, you know, uncertainty and probabilistic has meaning if you're talking about a specific situation. But when you're talking about a generic situation, I'm having trouble rationalizing what that means. I mean, if you're just trying to demonstrate that Monte Carlo can do probabilistic arithmetic, you know, we know that, but what's the significance of it? MR. EID: I agree with you. I think the -- at the end, if you think that you have all sorts of mixtures of radionuclides at your site and all sorts of environmental conditions and then you need to go look at the 90th percentile, and then when you apply it, you find that you are not at the 90th percentile, you are at the 99th percentile, you will have excessive dose for sure. The question is what to do about it. This issue was raised and there was a suggestion for a grouping. I guess there was also a suggestion by the ACNW, by the way, about almost -- how many months? -- nine months ago in the presentation about the grouping of radionuclides, for example, uranium and thorium, or other kinds of radionuclides. This way, you could reduce the extent of conservatism in this process, grouping possibly on -- based on soil types, that you don't need to have KD value that corresponds to all kinds of soil types and all types of geochemical conditions, a grouping possibly based on environmental conditions like rainfall. So those are the possibilities that, you know, we could do as far as screening. MR. EID: This is Mark Thaggard. Would you like to add onto that? MR. THAGGARD: Yes. I think your question is why are we trying to calculate the probability on this. I think the original idea was to try to come up with the confidence that at any given site, you're going to see the dose criteria, so that if you -- the idea was that if you go into the dose assessment analysis with no information about the site, these -- PDF is supposed to be based on national data, so if you take any site in the country, just randomly pick a site no know nothing about that site, and you run a dose assessment, what is the probability that you're making a mistake by releasing this site when, in fact, you shouldn't be releasing it. This was the original idea of trying to come up with a probability. It was to give us some level of confidence in terms of whether we are releasing sites that we shouldn't be releasing, and there's some debate as to whether or not we are correctly quantifying that, but that was the original intent. I don't know if that answers your question. DR. GARRICK: I think that's an expression of honesty. MR. NELSON: I would like to follow up on that, because Bobby brought up an example during his discussion of an existing problem where, if you run RESRAD as it -- or D&D as it is now for strontium and cesium, you get ridiculously high numbers. They don't make sense. And that's because the default parameters set has been established based on all radionuclides rather than given radionuclides or a given mixture. What the Monte Carlo version will be able to do is you'll be able to put in a specific mixture, it will calculate the default parameter set for that specific mixture and give you a screening value for that mixture. We have done that. Bobby has looked at that for the strontium and cesium, and have compared it to RESRAD, and the values, once -- when you do this for a specific radionuclide mixture, they come much closer to what RESRAD would give you for the same calculation. They're not exact, but they're within an order of magnitude closer. So that's the value. It's still a screening tool, but it gives you a better screening value, a more realistic screening value based on the radionuclides you have rather than assuming that every radionuclide that -- is there. DR. HORNBERGER: When you say it gives you a more realistic value, more realistic compared to real data or more realistic compared to RESRAD, which we don't know what the result means anyway. MR. NELSON: Well, when I say realism, I guess it's a subjective realism. When you look at what D&D gives you for strontium 90 at a pico curie per gram and it says that your dose is going to be 60 millirem per year, that, to me, is unreasonable. Okay. So by lowering the number, that becomes to me more realistic. Whether it's the exact right number or not, I don't know, but it certainly gives you an answer that you don't say, well, that answer is worthless, 60 millirem. Of course it's not 60 millirem. So in the calculations that we ran, and these were preliminary numbers, but the strontium dose went from 60 under current D&D to a little under 15 with the Monte Carlo approach, and that's compared to about five for RESRAD. So it's a significant change for someone who is doing a screening review. I mean, if they can pass it at 15, but they've got -- if they've got 15 or somewhere in that range and they're stuck with trying to screen 60, I mean, there's just -- you know, it seems a significant difference there. So I think it's -- I think the code -- the improvement is of great benefit in the screening area because it's going to give numbers that are tailored to the radionuclides that are of interest. MR. LARSON: I didn't think it was two codes that were similar for each different radionuclide. That's for some radionuclides, one was higher than the other, and depending -- you know, so -- it sounds like there was a lot of changing that you had to do to get similar realistic or unrealistic results for each of the radionuclides. MR. EID: I believe the two models here are different. They would yield somehow different values. However, if you try to adjust the source term to make it similar, say make RESRAD, the top 15, the contamination the top 15 centimeter, and the thickness of the unsaturated zone around one meter, that's one thing to try to shape your source term, to make it similar to D&D, and then try to input a default value similar to what we have in D&D, you will get, somehow, some comparable values. An example for cesium, I found that the -- after -- you know, for a single radionuclide, if you do that, you will get 2.27 and 2.3. It is not a joke, those are real numbers. I ran them. They are so close to each other. So the models possibly -- yes, we had differences in the models, and we may have differences in the peak dose at the time, I guess. You know, this is also another difference because one model tends to retard, other model tends to have infiltration and the material moves much faster through the aquifer. However, at the end, it looks like the numbers are similar if you adjust the source term, the default values, and if you look at the right time for the peak dose. DR. GARRICK: Do you want to say anything more about the workshops themselves and how they went? MR. ORLANDO: Well, as Boby said, based on the comments that we got from the participants, they were extremely appreciate of the fact just in general that the staff is doing this outreach before we write down what we think the answers are. There is concern from the industry on exactly some of the issues that you raised -- you know, why do we have two codes? You know, what's going on here? The industry, my impression, and this is just my impression from the workshops and it may be rather simplistic observations, but the industry, especially the nuclear power industry, is extremely concerned right now about costs. They always have been, but with deregulation, I think they're even more concerned. They are concerned about making sure what they do is being done cost-effectively in decommissioning. For example, they are very interested in seeing if they can't take their thousand-acre site that is 95 percent buffer zone and getting it down to something that includes the parking lot, the reactor building, and the areas that actually have been impacted by operations. They don't want to be in a situation where they're out surveying via MARSSIM woods. So that's things that they've come to us and talked about. In addition, they are interested in making sure that when they do the assessments that we're going to ask for -- and one of the reactors have indicated they're going to come in for restricted use. In fact, Paul Genoa from NEI has said that's not going -- that none of them are planning that right now. But they have come in and I think they're concerned about finality. They realize that, you know, the license termination rule is relatively new, the Part 50 rule is relatively new, they're struggling with sending in the first post-shutdown facility decommissioning activities report, the PSDARs are just starting to come in. That's the first thing that comes in when you shut down a reactor, or after the certification. Nobody sent in a licensed termination plan yet. They're interested in the interlink between the decommissioning plan standard review plan and the license termination plan review. One of the things we did at the last workshop was very -- this question came up, and we did a very quick sort of ad hoc overview of the interaction between NMSS and NRR with respect to reviewing license termination plans and decommissioning plans, and I'm not sure that the industry understood that, at least the power plants didn't. On the materials side, their concerns are the same. They see -- they're more used to dealing with decommissioning plan concepts and things, so it's not too bad, but they still have the concerns that the power industry has, finality, making sure that what they send in is done, doesn't generate reams and reams and reams of requests for additional information and additional justification and everything else. One of the things that my management has told us is that they want to see us start limiting the numbers of requests for additional information to one. Have the interactions with the industry during the reviews of the plans, publicly notice it, publicly -- make that information publicly available, but don't have ten or five or three, you know, sets of 60 questions going back and forth. Then there are the technical questions, looking at -- you know, finding alpha emitters, measuring that under the MARSSIM, partial site release even for fuel facility plants, things like that. So I think, to sum it all up as far as the workshops, I think they've been good. I think the industry appreciates the fact that we're doing this. I think they are slowly -- probably not by this time -- they're comfortable with coming in and talking to the staff about things that they find and problems that they have. So I think they've been good. That's just sort of my observations on the things that have come up and the things that I heard while I'm sitting there in the workshops. MR. EID: I would like to add to Nick that in addition, the data that is generated by the licensee and then we use, it is really invaluable. The data is so important we do not find it in a published paper or in a journal, and that is we -- after going through the QAQC of the data and we feel confident using the data that they have, this will give us one step further in moving towards using the right thing. MR. ORLANDO: Yes, as Boby said, you know, for resuspension factors, really the only study was what -- that's the '66 data, I think? '64 data? MR. EID: The reference we use is '63, '64 data, and we have some skepticism from the beginning about the data, how it was used and so on, but because it is the only reliable data -- it was published in the Journal and has lots of data points, so we use references, and we are updating this information. DR. WYMER: There is a sort of a sleeper out there with respect to this decontamination and termination of license and restricted license termination that has to do with the potential ultimate role of NRC and what are now DOE's problem. You know, if you take over regulation of the DOE sites, what thinking have you done with respect to that? And the kind of thing I'm thinking about in particular is when you look over the DOE sites and their potential long-range problems, one of the big things you see is there's a lot of -- an awful lot of pump and treat going on forever, essentially, because you never really do get the activity down. Have you done any thinking at all or is it too premature? You've got too much on your plate to even worry about that right now if you do take over the DOE problems? MR. ORLANDO: Well, officially, my understanding is that Secretary Richardson has kind of pulled back from that a little bit. There's not -- DR. WYMER: Yes, but secretaries come and go, you know? MR. ORLANDO: Yes, that's true. Congress has not finally spoken, so I'm not sure where that is going to go. To be honest with you, no, I haven't -- or I don't think we have thought about how we would manage a DOE facility other than if it were to remain, you know, pump and treat forever, then it would remain under some kind of license or some kind of regulatory control. It seems, just off the top of my head, it would be relatively easy to impose the restricted use criteria on that facility in a 25 millirem, 100 millirem if there's a -- if loss of control, or a 500 millirem under the alternate criteria. Maybe a DOE facility -- you could never terminate a license. DR. WYMER: Yes. MR. ORLANDO: And maybe there wouldn't be -- again, just my opinion -- maybe there would not be any utility in ever terminating whatever regulatory hook we have at a DOE facility if it's that badly contaminated, or if they're continuing those kinds of operations. DR. WYMER: Yes, but surely you're not turning your attention to that problem until it becomes your real problem. MR. ORLANDO: Right. Right now, we're just, again, trying to -- at least for restricted use, we've enough things to do with the fuel cycle facilities and other folks. DR. WYMER: Yes. Okay. MR. NELSON: This is Bob Nelson again. I agree with Nick, we really haven't factored potential of overseeing DOE into this development process, but DOE has -- representatives have attended the workshops and they have commented on various issues as we go through them. So they have been a participant, and we hope they will continue to be a participant in the workshops. So we value their input, but we're not, within the scope of with document, trying to -- looking at it as potentially encompassing DOE sites. DR. WYMER: Are you making sure you're not building yourself into a hole? If that does happen -- I don't see anything in it that would indicate that you are constructing a situation that you won't be able to dig out of if you do take over the DOE stuff. MR. ORLANDO: I don't think so. I mean, if they're going to go for unrestricted use, they can -- DR. WYMER: Well, unrestricted, there's no problem with it. MR. ORLANDO: Yes. DR. WYMER: It's the restricted use. DR. GARRICK: At DOE, it's a problem. MR. LARSON: At the last workshop, the DOE guy got up and said, I don't care what anybody else is using, but we're using RESRAD. MR. ORLANDO: That's true. That was a DOE guy, yes. MR. LARSON: One question on the schedule. I ought to remember it, Nick, but I don't. You're coming back into the committee after you get the public comments and gin them up so -- isn't that towards the end of the year? MR. ORLANDO: I believe so, yes, or we can come back at some other time if you're interested to discuss some of the issues after you've had a chance to think about them. I think -- I would have to go back and look at the actual time line that we did. I mean, I can't answer it -- MR. NELSON: We're scheduled to issue or complete the draft modules with the exception of dose modeling in June, so if we're no schedule, everything should be done but the dose modeling guidance in June. If you'd want to have a brief in the late -- I don't think you're meeting in August or September, so if you -- if you want to have a briefing in July on the SRP up to that point, we could probably do that, but we would have to look at the specific schedule. But it might be too close to actual completion of the SRP to do that. Maybe the early Fall would be a better time. We'd have completed most of the workshops by that time and could probably -- and would be a lot further along on some of the dose modeling issues at that point to give you a better status report. DR. GARRICK: Any other comments, questions, discussions? Thank you for the update. MR. ORLANDO: Thank you for letting me introduce the people who sat over there who did most of the updating. DR. GARRICK: And I think we'll take our second break at this point, and I guess we'll go off the record for the rest of the day. [Whereupon, at 3:50 p.m., the recorded portion of the meeting was concluded.]
Page Last Reviewed/Updated Friday, September 29, 2017
Page Last Reviewed/Updated Friday, September 29, 2017