ML20205A684
| ML20205A684 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/1999 |
| From: | NRC ADVISORY COMMITTEE ON NUCLEAR WASTE (ACNW) |
| To: | |
| References | |
| NACNUCLE-T-0129, NACNUCLE-T-129, NUDOCS 9903310045 | |
| Download: ML20205A684 (256) | |
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i._s' i l DISCLAIMER l UNITED STATES NUCLEAR REGULATORY COMMISSION'S ADVISORY COMMITTEE ON NUCLEAR WASTE MARCH 24, 1999 l l l The contents of this transcript of the proceeding
,-~ of the United States Nuclear Regulatory Commission Advisory Committee on Nuclear Waste, taken on March 24, 1999, as reported herein, is a record of the discussions recorded at the meeting held on the above date.
This transcript had not i:een reviewed, corrected and edited and it may contain inaccuracies. I 1 i i l f% (_./
1 l l 302 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 *** 4 108TH ADVISORY COMMITTEE ON NUCLEAR WASTE 5 (ACNW) l 6 l l .7 Nuclear Regulatory Commission 8 Room 2B3 l 9 Two Whits Flint North 10 11545 Rockville Pike 11 Rockville, Maryland 12 13 Wednesday, March 24, 1999 14 h 15 The above-entitled meeting, commenced, pursuant to 16 notice at 8:31 a.m. l 17 l 18 MEMBERS PRESENT: 19 DR. JOHN B. GARRICK, Chairman, ACNW 20 DR. GEORGE W. HORNBERGER, Vice Chairman, ACNW 21 DR. CHARLES FAIRHURST, Member, ACNW l 22 DR. RAYMOND G. WYMER, Member, ACNW 23 i 24 l. 25 O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
1 l l 303 1 PROCEEDINGS 2
-( [8:31 a.m.]
3 DR. GARRICK: Good morning. I believe it's
- 4. Wednesday, March 24th, 1999. Our meeting will now come to 5- order.
t
- 6. 'This is the second. day of the 108th meeting of the 7 ' Advisory Committee on Nuclear Waste. My name is John !
l 8 Garrick, Chairman, ACNW. Other members of the committee i 9 include George Hornberger, Ray Wymer'and Charles Fairhurst. 10 We will.re-welcome and re-introduce our two 11 consultants, Dr. Otto Raabe and Dr. Kim Kearfott -- and we 12 also continue to welcome the member of our sister company I 11 3 and that.is the Chairman of our sister company, Dr. Dana
'14 Powers.
() 15 Today-the committee will continue our discussions 16 on low levels of ionizing radiation and allow.the public to 17 hear their views on the presentations we heard yesterday. 18- We have some other business to do. We will meet with John 19 Greeves, NRC's Director, Division of Waste Management, to 20 discuss developments at Yucca Mountain, rules and guidance 21 under development, resources and other sources of mutual 22 . interest. We will review progress on the development of a 23 clearance rule for materials and equipment having residual 24 radioactive contamination, and we will review the status of 25 the Decommissioning Standard Review Plan. IdM RILEY & ASSOCIATES, LTD.
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304 1 Mr. Howard Larson is the Designated Federal
~D 2 Official for the initial portion of today's meeting and as
[O 3 usual this meeting is'being conducted in accordance with the 4 provisions of the Federal Advisory Committee Act. 5 Aside from the announcements we made yesterday 6 regarding people who wish to make remarks and comments, we 7 have received no other written statements or requests from l 8 members of the public regarding today's session. 9 Should anyone wish to address the committee, 10 please make your wishes known to some member of the Staff 11 and as usual we appeal to you because of the need for 12 recording your valuable words to use a microphone, identify 13 yourself, and speak with clarity and volume so that we can 14 hear your message.
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(%) 15' So I think where we are today we are going to 16 continue our discussion, continue to hear from selected 17 numbers of people and hopefully advance this thing to a 18 point where we have a basis for developing some sort of a 19 letter or report for the Commission, and with that I will 20 turn it back over to our lead member on this subject, Ray i i 21 Wymer. 22 DR. WYMER: Thank you, John. I think the i l 23 appropriate way to start this out for the benefit of the 24 people who may -- there may be a few -- who weren't here 25 yesterday, to state what the purpose of this meeting is, [ ANN RILEY & ASSOCIATES, LTD. (- Court Reporters 1 1025 Connecticut Avenue, UW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l )
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'l I
!- 1 305 1 1 . what-we-hope to accomplish. I i 1 2- The purpose of the meeting is to update the 3- Advisory Committee on Nuclear Waste with respect to the i l 4- research and some of the debate regarding the linear j 5 non-threshold hypothesis so that the Advisory Committee can 6 advise the Nuclear Regulatory. Commission on actions related 7 to the LNT as applied to radiation risk of low level 8 ionizing radiation.
- 9. That'is our purpose and in addition we wanted to ;
10- maintain a high level of visibility of this very important 11 topic in the Commission and in the public at large because 12 -we think it is a very important issue, one with profound 13 financial implications as well as health implications. 14 -This morning we will continue with discussion from () 15 the audience with respect to their points'of view and their i '16- -interests and points they want to make'in this area of LNT ! l l 17 and following up on the procedure of yesterday, I want to ! 18 turn it over to Michael Halus, who was facilitating i 19 yesterday's panel discussion and who will also facilitate : 20 the discussions this morning. Mike? ; 21 MR. HALUS: To reidentify the purpose for this 22 particular portion of the meeting, that is, the panel )
- 23. discussion, the purpose is to further explore the issues j
24 associated with LNT with a view towards searching for gaps L 25 in'the research and identify further actions for O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.-20036 (202). 842-0034
306 1 consideration and recommendation to the Commission.
% 2 We have invited people to make presentations on
.. )
3 it. I would ask people to constrain their remarks to a 4 20-minute time period so everyone who chooses to present 5 will have time to do that -- so is there anyone in the 6 audience who would like to make a presentation? They are 7 certainly welcome to do that. 8 Who would like to go first? 9 MR. ROCKWELL: Theodore Rockwell. 10 DR. GARRICK: Ted, you may want to go up here -- 11 we can see your wonderful physique better that way. 12 MR. ROCKWELL: Thanks. First of all, I want to 13 say that Ted Quinn, who is the President of American Nuclear 14 acciety wanted very much to be here and he called me at [Y
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15 midnight last night. He was still trying to get a later 16 flight out to Rochester, which I guess there aren't a lot of 17 enem, and he didn't make it, but he asked me to convey the 18 concern of the American Nuclear Society on the importance of 19 this issue and the tremendous burden that it puts on nuclear 20 technology to have to concern itself with these minuscule 21 levels and defend the fact when we are in a position of 22 saying we don't know whether we are killing people at one or j 23 two MR per year. 24 Incidentally, I got an e-mail last night from l 25 Zbignieu Jaworowski of the Polish Central Laboratory in Q As ,/ ANN RILEY & ASSOCIATES, LTD. Court Rcporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 j l (202) 642-0034
307 l l 1 Radiation and he told me the 48th UNSCEAR session will be i I \ 2 held in Vienna from 12-16 April. I am pre,>aring myself for V 3 it 100 percent of my time and he is -- they are going to , t 4 consider Cohen's work is specifically on the thing and other 5 epidemiological subjects relating to LNT and the whole basis 6 for the assumption of accumulating dose and so forth, and he 7 has got a paper here that he wants us to look over that he l i 8 wants to send out to the committee members ahead of time for ) i 9 their consideration on this whole business of collecting LNT ; 10 } doses and pointing out how absurd it is, and the way the i 11 thing is worded now and the way they are doing it is that 12 they want the sum of all annual doses over all the years in 13 which exposures continue over infinite time to account for j 14 exposures occurring to all future time from the average e-(g) 15 individual dose over all generations. 16 He plays this thing out all the way back to homo i 17 erectus and homo habilis -- a 18 [ Laughter.] ] i 19 MR. ROCKWELL: -- and points out that the billions 1 20 and billions of manrem that have been built up over that 21 situation and the .00000 contribution of anything we can do, , 22 and says for goah sake, fellas, let's knock this off. 23 I hope that any consideration you give you will 24 recognize that you are not alone in this thing. There are a l 25 lot of people -- the concern is building up that this is --
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308 1 I mean there comes a time when you have to say that the 2 thing has reached a ridiculous point.
'w 3 The other question -- this contract for this l 4 report, as I understand, was under Regulatory Research, is 5 that right, John?
6 DR. GARRICK: The NCRP -- 7 MS. THOMAS: Yes, the NCRP 1.6 was through 8 Research. - 9 MR. ROCKWELL: Yes. Is there anyone here from l 10 Research that is responsible for this report? l Has anyone i 11 been here to say whether -- l 12 MS. THOMAS: Shlomo? 13 DR. YANIV: I know that Vince Holahan -- 14 MS. THOMAS: Yes, Vince Holahan is on military [ 15 (j assignment at this point in time. He was the PM for this i 16 project. 17 MR. ROCKWELL: Well, do we know whether the people 18 who paid for this report feel that it answers the concerns 19 that they had that were expressed in the '96 meeting that 20 the thing would consider all of the data and that the 21 questions that have been raised in the past have been 22 satisfactorily answered and so forth? 23 Is anybody here to answer that question? 24 DR. YANIV: I can answer my personal -- 25 MS. THOMAS: Shlomo? O ANN RILEY & ASSOCIATES,. LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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309 1 DR. GARRICK: Use a microphone. [~h 2 DR. YANIV: My name is Shlomo Yaniv and I am with 'm 3 the Office of Research. Now the comments that I am going to 4 make at this point are my personal ones, having read the 5 draft report. I have not prep. red any remarks. 6 I was impressed by the scientific quality of the 7 report, the depths of analysis and I consider the report to 8 be a report on the state of the t of science in all 9 aspects of radiobiology from molecular to human epidemiology 10 including animal research, et cetera. 11 Obviously it cannot answer all the questions that 12 we would like to have the answer for reasons that have to do 13 with the nature of the science and the state of the science, 1 14 but it is an extremely good picture of the state of the A) i s 15 knowledge for the professional. 16 It is not an easy read and my personal opinion, 17 that the conclusions drawn in the draft report are correct. 18 MR. ROCKWELL: Are you satisfied that the concerns 19 that were raised three years ago by this committee and 20 others that have come in where specific questions were 21 raised that this is not valid because, this is not valid 22 correctly handled -- are you satisfied that all those j i i 23 concerns that have been specifically raised on the record 24 have been handled? 25 DR. YANIV: As I said, I have not prepared, I have l l [~D ANN RILEY & ASSOCIATES, LTD. \_s/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 310 1 not reviewed anything prior to our conversation and I am not (~') 2 familiar with the specifics that you right now ask or maybe V 3 don't remember at the moment so I cannot answer that in an 4 affirmative nor negative. 5 MR. ROCKWELL: But before the report is finally 6 approved for issuance, is anyone going to look over -- these 7 concerns have been presented before to this committee, to 8 the NCRP. People have gotten up and testified. Matter of I 9 fact, we have had concerns expressed to us that we have 10 heard all this stuff before. 11 You have. The question is has it buen responded - 12 to and if it is not going to be responded to now, do you 13 plan to go over these things and assure yourself -- 1 14 DR. YANIV: I cannot answer that question. I am
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(N) 15 not the Project Manager. I am a Staff member and as I said 16 I am expressing at this point my personal opinion. You are 17 getting into policy which I cannot answer. 18 MR. ROCKWELL: John, I assume that that will be 19 addressed in your letter? 20 DR. GARRICK: Well, we are going to review 21 evervthing we have heard and it will be the basis for our 22 letter, that's right. 23 MR. ROCKWELL: Okay. Well, let me turn this over 24 to Jim Muckerheide or to Myron -- either one -- whichever of 25 you guys want to -- what we want to do is to try to make (~'i (_,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
311 1 clear the nature of the concerns that we have and 2 specifically why -- I mean yesterday we only had minutes and 3 what we said was these things, these comments that we have 4 made have not been concerned and Arthur Upton got up and 5 said sure they have, and then he went on to the next topic. 6 We would like to get more specific as to why we 7 feel that these have not been raised, why they are 8 substantive, and why they should be approached. 9 MR. HALUS: For timekeeping purposes, we will go 10 ahead and start the 20 minute time period with the new 11 speaker, 1 12 MR. MUCKERHEIDE: I wasn't so much anticipating 13 making a presentation as pointing out some of the questions 14 that we would like to pursue. In responding to the (Aj 15 presentation yesterday by Dr. Upton, it seemed to me that we 16 have the classic example of having a number of slides that 17 represent the linear response that you get when you hit 18 cells with radiation, and they are cells in petri dishes 19 that have no biological systems that are immune-response, et 20 cetera, and so you bring out that data and say, see, it is a 21 linear response. It doesn't include cells that show 22 non-linear responses. 23 A lot of the slides start at a relatively high I 24 dose, even if it is only 1 rem per day, which is very low l 25 dose in high dose studies, but there is no data that goes l i ()
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1 1 312 1 below the 1 rem per day. And so you end up with this 2 presentation that says here is another straight line. (V~} 3 In addition, the data that shows cell and 4 Chromosome effects, we know from the radiation workers in 1 5 the U.K. that have been followed from the wind scale fire, ) l 6 the high dose group, they can see chromosome effects in that l 7 population. There is no associated health effects. That is 8 true in general, high doses are going to have more 9 chromosome aberrations, but, in general, a chromosome 10 aberration is a dead end and it doesn't necessarily mean l 11 there are health effects. In fact, in animals that show 12 beneficial effects, you can see excess chromosome 13 aberrations. 14 So the fact that they presented a lot of data from
/ 15 the biology literature that shows these kinds of effects, C
16 and yet it still comes out with the same old straight line 17 selected data continues to exist. 18 He made a statement about double-strand breaks as I 19 being normal activity is one in 25 years or something like 20 that, on one of the slides. Unfortunately, we didn't get 21 any handouts, so I am not sure that I remember this 22 accurately, but I was thunderstruck at that number. It is 23 clearly not part of what biology represents, although 24 radiation has a higher percentage of double-strand breaks 25 than single-strand breaks compared to normal biological (g ANN RILEY & ASSOCIATES, LTD. (j Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
313 1-
. metabolism, it is certainly nothing like one per 25 years.
2 Double-strand breaks are frequent in normal metabolism and 3 representing that they aren't is clearly contrary to the 4 current knowledge of biology. 5 We had a number of presentations that showed 6 responses from neutrons, et cetera. That is, of course, not 7 really relevant to anything that we care about in low dose 8- radiation response. 9 There was a statement I thought that was very i 10 instructive about radium-226 as being the one t:nng we ; 11 really know has a threshold, and, of course, we have all 12 known since the late '60s, early '70s, that the threshold'is 13 about 1000r, and in this-case we have radium-226 as a 14 threshold. I was interested in asking Dr. Pushkin about why 15 the fact that we already have radium-226 limits that are (O)
- 16. 125,000. times lower than that threshold, why they are now 1
17 still going through a rulemaking to further reduce 18 radium-226 limits in drinking water and why we went through 19 a whole exercise with radium-226 groundwater contamination 20' in New Jersey, with fears that were going to be damaging 21 people because they had more than 5 picocuries per liter. 22 The State of Wisconsin, the high dose, where the 23 high concentration area is in Wisconsin, Iowa, et cetera, 24 are going through now the fact that they may spend 25 additional millions of dollars to deal with the fact that O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
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l 1 they have radium in drinking water that is higher than the
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2 limits, and the new limits would add more millions of f l 3 dollars, and, yet, in this presentation yesterday, we 4 acknowledged that that is one of the very specific cases 5 where the linear threshold doesn't apply, or the linear 1 1 6 nonthreshold doesn't apply. 7 You were going to say -- 8 DR. GARRICK: No , no. 9 MR, MUCKERHEIDE: Oh, I'm sorry. There was a 10 presentration on' leukemia in the atomic bomb survivor studies 11 that typically ignores the low dore data point that was left i 12 off of one of the 1988 studies and has consistently in the l 13 literature been pointed out that the actual leukemia data in 14 the lifespan studies is inconsistent with how it was () O 15 presented in Shimizu '88. 16 The fluoroscopy data that was presented ignored 17 the fluoroscopy study of the Canadian women, except for the 18 high dose group in one part of the study, but not the other l 19 part of the study. It has been pointed out for years, since 20 Ted Webster pointed it out on publication of the original 21 article, that the data is highly indicative of hormetic 22 response for breast cancer. It is also highly indicative of 23 a response for lung cancer. 24 It was known at the time of BEIR V, and yet it is 25 the -- in the actual summary of BEIR V, it is the second I\ ANN RILEY & ASSOCIATES, LTD. (s Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 315 1 most significant study after the lifespan survivor study in i () 1 2 the document in terms of a person rem year, and is relied on 3 enormously for a straight line that is generated, has 4 straight line over a low dose decrement of one-third for the 5 breast cancer rate in that population. 6 More reference was made to the Cardis study of the 7 U.K., U.S. and Canadian workers, a study that basically 8 misrepresents its own data. The study authors, after having 9 published the study, and finally gotten some criticism for 10 the fact that they had come out in saying this shows a 11 linear response, several of the authors refused to make that 12 statement, yet the NCRP has continued to make it, and even 13 to characterize it as vindicating the linear model. And in 14 that study, it is clear that the only one cancer of the
) 15 couple of dozen that is in there, in a 1 out of 20 test, has 16 6 cases of leukemia versus 2.3 expected for greater than 40r 17 dose group, and on the basis of that one data point, draws a 18 straight line to zero, discounting all of the data in 19 between. We show no such indication, and, therefore, the 20 Cardis study, in its own presentation, misrepresented its 21 own data. I 22 And as Myron has always pointed out, as long as 23 you take 1P values, then you essentially ignore all the data 24 points below the line. Out of the seven groups, you only 25 have three that are above the line, and it happens to be h ANN RILEY & ASSOCIATES, LTD.
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I 1 l 316 ' 1 that the one at the end is high, so in 15,000 deaths, you i (~') 2 have 6 versus 2.3 in a greater than 40 rem dose group, and t G' 3 now the whole study demonstrates and proves the linear 4 model, and it gets referenced as though it does. And that 5 has been documented, it is documented in the Los Alamos l l 6 Science magazine. It has been documented in the literature. l 7 I mean it is not as though this is, you know, l 8 somebody's underground railroad, this material was presented 9 to NCRP, and they are well aware of. It has been presented 10 not just for this report, but before that. It came out in 11 meetings that we had in '95. l l 12 I want to pass over the Cohen data. I did want to 13 make one point though about the characterization of Cohen's 1 14 data as though it were an anomaly and somehow the result of in i(v) 15 one man's extraordinary treatment of this data, 16 If we go back to '87 when Cohen first took a look 17 at Cumberland County, Pennsylvania, and found that this 18 highest-radon county in his neighborhood had very low lung 19 cancer rates, and he compared seven other studies that 20 indicated -- around the world that indicated similar kinds 21 of results -- those kinds of studies were then published in 22 a number of places, and so we've really known about this 23 since before '87 really. l 24 Cohen kind of pulled this together in '87 in the 25 Health Physics Journal. He did two or three other interim l ("] ANN RILEY & ASSOCIATES, LTD. (_ ,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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317 1 studies, not all of which just literally led to the 1995 (~'j - 2 conclusion by the time he had all of the data that was so V 3 dramatic, but a number of studies are included and all 4 consistently reflecting the same kind of relationship. 5 But in addition to Cohen, you know, small studies 6 and minor efforts, but looking at the whole U.S. populatior
- 7. all shows the same relationship. You know, there's a 8 tendency to think well, Cohen went out and did all these 9 measurements and there may be some self-selection. Well, 10 last year Bogen at Lawrence Livermore looked at just the l 11 EPA's data on the radon based on the environmental l 12 measurements, and those environmental measurements were 13 correlated with residential radon concentrations. But if I 14 you take the environmental measurements over the whole U.S. l
() 15 and correlate it with the American Cancer Society's 16 statistics on lung cancer, and he looked at the women lung 17 cancer deaths, 1950 to 1954 as another set, but because the 18 women from 40 to 80 years old had 11-percent smoking 19 frequency and 4-percent smoking frequency in the women 60 to 20 80 years old, and when he looks at that he gets another 21 curve just like Cohen's, totally independent in any way, 22 shape, or form from Cohen's analysis and the way he got his 23 data and the way he made the analysis. 24 When Jaeger published and simply said hey, we're 25 going to take the high-dose States and the low-dose States
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318 i 1 and.see this enormous discrepancy, and it's very highly l /~h 2 statistically significant. Sandquist at Utah in '96 did a U. 3 cut at the data just on the EPA. regions and looked at 4 radiation in terms of the EPA regions based on the EPA's own l 5 cut at the radon in the country, and they got the same 6 results. They found that the lung cancer rate at the 7 highest-dose region was 14 percent of the EPA predictions, 8 and the lung cancer rate at the lowest-dose region was 390 9 percent of the EPA prediction, and that if you take each 10 region in between it's a consistent relationship. 11 I mean, this is not an anomalous kind of 12 situation. And yet BEIR VI itself treats Cohen as a nut on
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l 13 the fringe and misrepresents his data in the curve and l 14 characterizes that in a paragraph to simply say well, some j () 15 people would think this might represent that there isn't a 16 significant effect, and they leave it at that. And then l 17 they go about and they say we do a model that basically
- 18 draws a straight line and that's the end of it. And so this 19 whole process continues.
20 I commented yesterday that Norm Frigario, who I 21 knew in the seventies, and one of the reasons I got 22 exposed -- no pun intended, I guess -- to this whole subject 23 was when we were paying attention in '72 to Calvert Cliffs 24 and Appendix I, Appendix D, all the initial efforts because 25 of the new NEPA standards and writing environmental reports. (g ANN RILEY & ASSOCIATES, LTD. (,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
I 319
.1 I was working for Bechtel at-the time. !
I-.
'~)
)
2' AEC contracted with Argonne to do a low-dose study 3 specifically in response to Calvert Cliffs and a court's 4 decision that you didn' t do a good enough job, .and as a l 5 licensing initiative they made a contract and Argonne did a 6 study just to say here we have a population that's exposed 7 to low-dose radiation in thn same terms and conditions that 8 we're concerned about in t. :i of chronic exposure at low 9 rates, and we have significant differences or significant 10 enough differences, but we don' have nitty-gritty detail 11 data, we only have fairly coarse numbers about radon -- or-12 radiation. So just not including the lung cancer dose, just
' 13 ' looking at the radiation -- external radiation numbers --
14 this characterization that of course Colorado is lower and
) 15 the Southeast of the U.S. is higher in terms of all cancers, 16 and doing a number of socioeconomic confounding factors 17 assessments, this first cut at the data was a negative.
18 Well, that report was issued by Argonne to AEC in 15 '73, and that project was killed by Regulatory Research or 20 the equivalent of Regulatory Research in the AEC at the 21 time. And Norm Frigario eventually got that " published" by 22 going to an IAEA conference on low-dose radiation, because 23 he couldn't get it published otherwise, and it came out as a 24 proceedings paper. So it was a brief kind of form. And ! 25 that was referred to in BEIR III, and dismissed in two ANN RILEY & ASSOCIATES, LTD. O . Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
320 1 paragraphs. It was brought up as an UNSCAER 1977 document () i
'2 3
that was, suppressed at UNSCAER by the UNSCAER process that said well, we really_ don't know if this is serious. B', t 4- nobody went back and looked at the fundamental analysis that 5 was done'on the Argonne study., they all just said well, we 6 got this one little paper in a proceedings and that's what 7 we're going to build our de' cision on. And before Norm died 8 in '78, '79, he was completely convinced that the 9 characterization and the inability to get the document 10 published was simply a result of the commitment to LNT. 11 At this meeting in '96, that meeting of the 12 subcommittee in '96, Charlie Willis, who recently died here 13 at the offices as I understand actually being here overnight 14 made a statement -- O) ( 15 MR. HALUS: You have five more minutes. 16 MR. MUCKERHEIDE: Made a statement that said I 17 came to hormesis fairly late. In 1958 I was_at Oak Ridge -- 18 or he didn't say Oak Ridge -- I was at the lab, and they had 19 potassium without potassium-40, and they were doing cell 20 studies. And the cells looked good but they didn't 21 function. And it was the LNT -- and he made the additional 22 statement -- it was the LNT tLat kept that work from being
, 23 published. Now we know that the potassium-40 was removed 24 from potassium through the calutrons at Oak Ridge to do 25 biology experiments through the fifties. There was a 1962 O ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
p 321 1 dated bottle of the stuff that was used at Argonne in 1982. ( 2 And that material was reco'.ered from animals, in fact it was 3 contaminated because it had been recovered from animals l l 4 because it was so valuable, and Argonne actually got another 5 kilogram or something of it made up, about $75,000 sometime ' l 6 around '80 or '82, and yet you can't find any of the 7 published results of that in the literature. 8 And reports of people who were around the biology l 9 community at the time said oh, yes, we did mice experiments 10 with that, and when the material was there, we had seen the 1 11 detrimental effects on animals. But that work couldn't get 12 published. In fact, you can't find it. You do a search in 13 the literaturo, you can't find anything about biology 14 experiments. And you look at this in the context of what's A i,
) 15 going on tc. day and realize that for 40 years this process of 16 basically aanying that the data exists is part of our 17 legacy.
18 It became important in the fifties partly because 19 it was the argument against allowing the military to have 20 control of the bomb and some of the argument against 21 above-ground tests in order to pursue the issue of public 22 fear of fallout, and some of it was public fear enough to 23 work against the post-Korean War period of the Atomic Energy 24 Commission and the Army basically trying to say hey, with 25 tactical nuclear weapons we can get into the battlefieltl,
/~ ) ANN RILEY & ASSOCIATES LTD.
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322 1 and there was some concern that this thing would get back
~
2
] under the umbrella of the military, especially after a lot 3 of the successful experie es with putting the soldiers in 4 the field with weapons. So part of the campaign was to 5 create public' fear about fallout, part of the official 6 government campaign of people I know who were involved in 7 the time, Robley Evans said he was involved at the time.
8 One of the great mistakes we ever made. i 9- But now we're stuck with this, and _.'s, as I said 10 yesterday, whether you think of it in teims of the biology 11 of the LNT and its fraud, or the actual consideration of how
.12 much radioactivity you're putting into the environment and 13 whether or not it has an effect, you can't justify spending 14 the. hundreds of billions of dollars we're justifying other
() 15 than to say the public is being mi.71ed. 16 And the one last statement-I intend to make just I 17 on this point is"I thought Greta Dicus' comments were quite 18 salient about this significance about what we have to do 19 about protection and why it ought to be cost-effective, but 20 there's an element that keeps coming in in her remarks and 21 ' subsequently that says well, it's the public demands it. 22 I'm here to tell you as I kind of said. yesterday J 23 that the public only demands it because they've been made 24 afraid by the. kind of promulgation of a misrepresentation of 25 the nature of radiation health effects that this agency as
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F;: 323 y 1 well as EPA and DOE and others are directly accountable for 2 because they promulgate this stuff, and it's the (} 3 promulgation of an NCRP report in an unexamined way'that 4 leads us directly to the point that we're at. 5 There is a lot more on the presentations of others 6 that I would' address. I don't know how you are going to run 7 the meeting itself. i 8 DR. WYMER: Well, we'll give other people a chance 9 next. i 10 MR. MUCKERHEIDE: I appreciate that. 11 DR. HORNBERGER: Could I ask just one question? I 12 DR. WYMER: Sure. 13 DR. HORNBERGER: Jim -- I'll try to phrase this 14 ' carefully. In your view, if we had a completely neutral, () 15 unbiased group of scientists look at all the data,-would l .16 they' inevitably come to the. conclusion that there is a 17 threshold for an effect? 18 MR. MUCKERHEIDE: It's inevitable. 19 DR. HORNBERGER: And do you have any idea as whe:.e l 20 that threshold might be in a regulatory sense? 21 MR. MUCKERHEIDE: Ten to 20 rem. 22 DR. WYMER: Thank you. 23 DR. GARRICK: Can we have some more questions? 24 DR. WYMER: Go ahead. 25 DR. YANIV: I would like to make just a brief ( ANN RILEY & ASSOCIATES, LTD. O-1e Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
f 324 l 1 comment to bring to the attention of-the committee a fact 2 that the speaker addressed NRPB, British standard of nuclear L 3 workers. Just two weeks ago an expansion of this standard 4 has been published with a much longer follow-up and greater 5 statistical strength. 6 Now I have not read this standard. All I know l 7 about it is what I read in the latest issue of Nucleonics 8 reported on this study, 9 I want to make an additional personal comment. 10 The speaker indicated that the threshold might be within 11 about 20 rads of, say, effective dose equivalent. Now this 12 is a level coming up -- about from natural background and 13 medical procedure over lifetime, and let's just assume that 14 he is perfectly correct and that there is no linearity above () 15 natural background, et cetera. 16 Now just imagine the regulatory scheme under those 17 circumstances. First of all, we won't be able to discount 18 natural background or medical irradiation because the cell 19 doesn't care, it doesn't know what it comes from, manmade or 20 non-manmade. 21 Secondly -- so once we reach the threshold from 22 whatever source it might be, every milli or microrem is not 23 equal to another microrem and on top of that we do not avoid
'24 the linear scheme. I don't think I have to continue to l
25 imagine the nightmare, the almost total impossibility to do O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 , Washington, D.C. 20036 l (202) 842-0034 l
l 325 11 anything. !( 2 Basically, I would just say be careful what you ! 3 wish-for, you might get-it'. 4 [ Laughter.] l 5 MR. MUCKERHEIDE: Well, I find it --
)
l
- 6. DR. YANIV: I will underline this is my personal
]
7 opinion. 'It is not anyone else's position. l 8 MR. MUCKERHEIDE: 'It strikes me -- two things. l 9 Number one, we have many toxic materials that we put in our h 10 vitamin pills that we are able to manage quite well. The i 11 idea that we become into a nightmare because we give up a 12 straight line doesn't seem to me valid. 13 On the other hand, if you want to have a straight 14 line, have a straight line, but the issue is not to cook the
) 15 science to help you prove it and not to pretend that it is a 16 scientifically based straight line. Make it a policy-based 17 straight ~line but don't bias the science in order to justify 18 it.
19 DR. 7ANIV: The question is who is cooking the 20 ~ science. 21 MR. MUCKERHEIDE: NCRP. 22 DR. YANIV: That is your opinion. , 23 MR. ROCKWELL: No, that's a fact. 24 MR. 14UCKERHEIDE: That's a fact. I 25 MR. HALUS: If we can, there are other people I i 1 j ANN RILEY & ASSOCIATES, LTD.
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r 1
)
326 1 think that want to have comments and presentations. [~ ) 2 We have noted a disagreement on that, but let's
%/
3 move the process forward, please. 4 DR. POWERS: I wonder if I could ask the speaker a 5 question. 6 I think you have made some sort of a case that Dr. 7 Upton has acknowledged that hiaybe you didn' t do a real good 8 job in taking into account some fraction of the data, and, 9 has made a commitment to do something better. 10 Do you think that is going to change the outcome 11 of the report, which to my mind basically says there is a 12 lot of data out there. It doesn't yet have a consistent 13 interpretation. We need to do more research. 14 MR. MUCKERHEIDE: Do I think it will change it? I O) ( 15 No. The data has never changed the reports in the past. 16 DR. POWERS: No, no, I'm -- I will concede a 17 certain disinterest on the part of the authors of this and 18 say that having examined the studies very carefully, would 19 it change the conclusion of the report? 20 MR. MUCKERHEIDE: Oh, yes. Oh , yes. 21 DR. POWERS: You think that these studies that 22 were neglected are so persuasive that even in the face of 23 the stringent statistical justifications that you have to 24 have that they would l'aad to -- there would be no need for 25 any additional research, it would just become obvious? (~ i ANN RILEY & ASLJCIATES, LTD. (_ / Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
c-327 1 MR. MUCKERHEIDE: It would become obvious. 2 You look at it in one sense and this isn't the j 3 only way to approach it, but in Japan in the early '80s up
'4 to about '85, '86, '87 they did a series of experiments with )
5 mice-that if we look at what we are doing today'in molecular 1 6 biology and by the time you get two experiments people are 7 ready to do clinical trials -- well, they did a'whole series l- 8 of experiments and showed the stimulatory effects of l 9 radiation at 10 to 15 r that was enough to start clinical 10 . trials and the stimulatory effects of radiation in mice was l 11 ' dramatic 12 They in 1986-87 were treating cancer with 13 stimulatory effects. They got into the same bind that the 14 medical establishment here has gotten into, because they l 15 couldn't get public funding for it because, as one of the 16 Japanese research managers said,-ICRP was against it and we 17 couldn't get government money to support it so only a little 18 private money was available, but they started a clinical 19- trial on non-Hodgkins lymphoma anyway and'found a dramatic 20 improvement in the success rate of treating non-Hodgkins i ! 21 lymphoma patients, even though the only point at which they l 22 got to treat the patients was at the point where they were 23 pretty much beyond hope in terms of normal procedures, and l 24 if you are going to try to stimulate the immune system I l 25 ideally you would do it a little earlier but out of that i O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L
328 1 population of patients they saved a number of patients over 2 the five year survi~al rate and now in the last year or so I
- Q[~h 3 the 10 year survival rate.
4 To end up, here is Ted Quinn. Welcome, Ted -- and 5 so if you are in a mode where people are actually treating 6 _ cancer successfully by stimulating immune function then you i 7 have got that kind of underlying science, but the issue is l 8 whether or not that science is acknowledged and recognized 9 when it comes to the subject of radiation protection, so 10 part of the disconnect here is that a lot of the biological 11 sciences and a lot of the interest in some of this 12 information is not considered in this process. 13 A similar situation of not being able to get at 14 the data exists in the Cobalt-60 contaminated buildings in (Oj 15 Taiwan. t 16 .IMt. POWERS: Well, I guess what I am saying is l 17 that you have a_ lot of point studies. Other people have a 18- lot of point studies. There ara viewgraph after viewgraph 19 after viewgraph of point studies. There still isn't a model 20 that connects all these results that says ah, yes, I can 21 explain why this guy got this and this other guy got this
- 22. other thing.
23 MR. MUCKERHEIDE: I don't agree. 24 DR. POWERS: In that kind of an environment,
~25 people will say gee, we need more research. I mean it is l l
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H 329 1 not the most novel outcome of the study -- and I don't see ("T 2 how additional point models -- point studies change that 3 conclusion. 4 MR. MUCKERHEIDE: But you swing from the fact that i 5 I make one example and treat it as though it is just a 6 point. The fact is there is a whole spectrum of studies and 7 part of why we ended up putting some of this documentation 8 ! together, even though it kind of became just contributions ! 9 from a number of people, is that there is a wealth of data. l 10 In fact, in 1980 the first book on hormesis had 11 1269 references. It has been going on since the 12 turn-of-the-century. I mean Calabrese referred yesterday to 13 the debate at the early part of the century was whether or l 14 not it is a direct stimulation or whether it is a damage eg ( j 15 response. 1 16 I mean this isn't new information. There's 17 literally a world of information that just is not 1 18 considered. 19 DR. POWERS: But what I don't see is one of these 20 plots that has dose across this thing -- the horizontal 21 axis -- and something on the vertical axis with a curve 22 coming in and then some sort of a threshold mark on it and I 23 have got lots and lots of point spidies. I just don't have 24 a model that puts everything together. 25 MR. MUCKERHEIDE: Now, wait a mirute. We are I ANN RILEY & ASSOCIATES, LTD. (^) (_,- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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r 1 330 1 asking you to do that. The only reason it doesn't exist -- 2 DR. POWERS: You're not asking me, trust me.
) I am 3 the wrong person to make that plot.
4 MR. MUCKERHEIDE: I will ask the ACRS or the NRC 5 or however you want to look at it, but those of us who have 6 commented on this since the '70s have said the only reason 7 that doesn't exist is because we can spend $100 million to 8 do a Hanford health study, $100 million on Hanford and we 9 can't spend money doing an assessment of the real data. 10 We can clean up Hanford for billions but we don't 11 have that job. That job is with the NCRP. 12 DR. GARRICK: Let me ask a question in connection 13 with that. 14 You .ake the point of the dangers of doing () 15 research and analysis from the point of view of a single 16 cell and chromosome effects without biological interaction. I 17 You were here yesterday when we heard about the DOE research 18 program. 1 19 What is your view about that program in relation 20 to that issue, in the relation to tying the phenomena at the 21 single cell and chromosome level with the biological 22 . systems? l 23 MR. MUCKERHEIDE: The world of doing that research
, 24 is very important. It needs to be done.
L 25 -The idea that somehow it is a de novo program I O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
331 1 think is false. There is a lot of data. There's the data 2 that hasn't been considered -- in fact, we don't even have 3 computerized Russell's data, spending $100 million over l 4 however many years in the early '50s to the '90s, doing the l 5 mega-mouse studies at Oak Ridge. That data hasn't been 6 computerized and for about a half a million dollars it can 7 be computerized and there is an enormous amount of data 8 there that is worth recovering, and yet we always seem to 9 treat this as though, hey, there's new work to do, and in 10 fact there isn't even really a substantial pursuing of the l l' issue that Russell's data was cooked in 1951 and that that 12 was stated -- in fact, what was interesting yesterday, one 13 of the points, was well, you know, we are concerned about 14 the genetic effects not of genetic effects so much as ()
/m 15 genetic related diseases.
16 Well, what is not really said there is that when 17 it was identified that Russell's data in 1951 that talked 18 about a. doubling dose of 100 r was not including the cluster j 19 of mutations on exposed population it became clear that the 20 actual genetic damage had a doubling dose of between 500 and 21 600 r, which is virtually a lethal dose, and so that the 22 whole idea that there could have been genetic effects went 23 out the window and so since that came up and those records 24 were sealed in 1995, by the way, and since that came up the 25 whole ICRP process has shifted away from, you know, we don't l T'T ANN RILEY & ASSOCIATES, LTD. (,,) Court Reporters 1025 Connecticut Avenue, NW , Suite 1014 Washington, D.C. 20036 (202) 842-0034
I 332 1 have genetic effects but we are concerned about genetic [sN -) 2 diseases -- and we have never identified a genetic disease 1 i 3 associated with radiation, but now that is where all their i 1 ! 4 genetics research money is going because we no longer have a 5 genetics problem. 6 But nobody has pointed out that it is because 7 somebody, you know, opened up the files and said, hey, you 8 know, the data stinks. 9 DR. GARRICK: Let me ask another question, a 10 follow-up about research institutions. 11 You have also sort of made the point that there 12 seems to be an institutional commitment to the LNT by those l l 13 bodies that are normally entrusted with being the experts on I 14 radiation effects, such as the NCRP. Maybe you include in (Oj 15 that the NRC and maybe you include in that the National 16 Academy of Engineering -- because of the BEIR reports -- 17 MR. MUCKERHEIDE: No -- actually the National 18 Research Council. i 19 DR. GARRICK: National Research Council. What is 20 your view, and this question was presented yesterday, of 21 creation of bodies or institutions where you think that 22 there would be a high likelihood that the total database o' 23 merit would get reasonable consideration? 24 MR. MUCKERHEIDE: I don't have a conclusion. My 25 one view has been that we have an NCRP and an ICRP and they [ h ANN RILEY & ASSOCIATES, LTD. ( s/ Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
E 333 ! 1 have tended to have a focus 01 adiation protection and they
,x ; i 2 are funded by the radiation p ;tection agencies and as a
, \~/I l 3 result we really don't have a full consideration of biology, i 4 medicine and health sciences, physiology, et cetera, that a 5 lot of the literature that exists is in biological sources 1 6 that are not generally considereu to be part of the 7 radiation protection establishment. 8 One of the comments, for example, well, some of 9 these sources are, you know, publications that are remote. 10 I And I look at, for example, last year there was a j 11 publication in " Gerontology," in May of '98, in France they 12 took 300 mice controls, all in one room, 300 mice with 13 thorium under the cages, 7 mr per year, 300 mice -- 14r per 14 year -- 14r per year. The two exposed populations lived r (),) 15 statistically significantly longer than the control 16 population, which is what we have always seen when you have l l 17 whole animal exposures. 18 But that data, I didn't even really pick up on it, l 19 but that data certainly doesn't get to the radiation 20 protection establishment. But there are dozens, hundreds of 1 21 studies. I mean this is where the literature exists that is 22 almost excluded. If it is not part of the establishment 23 science mainstream, then they tend to ignore it. 24 And it is easy for anybody from that side of the 25 aisle -- and one of Don Luckey's problems, for example, ( ANN RILEY & ASSOCIATES, LTD.
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I 334 ) biochemistry, head of the department in a school of 1 i [N 2 medicine, concerned about nutrition, concerned about i \m / l 3 antibiotics, developed the understanding of the stimulatory 4 effect of antibiotics in chickens and small animals, and it ; 5 is used in agriculture. He established the principle of 6 insecticide hormesis because if you -- and we all know that 7 you have got to take your full course of antibiotics because 8 otherwise germs get stronger. I mean all of this is part of 9 the same biological mechanism. But when he published it on i 10 radiation, even though he had already done it on heavy I 11 metals in toxicology, well, wait a minute, he is not a part 12 of the radiation business, so he is over there. And when he 13 tried to get funding, just like the guys in medicine who 14 tried to get funding at Johns Hopkins or the University of im ( ) 15 California at San Francisco, there is no funding. If it is 16 radiation, you have to go over there. 17 And Professor Kondo in Japan basically concluded 18 only in China is public health controlling studies of ! 19 radiation effects. All the other countries of the world, 20 essentially, treat radiation separate from the public health 21 establishment, and so we value these things differently. 22 So mv argument conclusion is you need to move it 23 into an arena where the public health establishment, that 24 doesn't have a vested interest in radiation and radiation 25 biology, can apply the normal standards that they apply to l [~} (_) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
[. 1 335 I: 1 whether or not there are effects and whai. those effects are. iO I \g
.2 MR. HALUS: We have nad a good discussion on this 1
i 3 particular topic. I believe taere are other people who 4 would also like to make. comments. Should we provide them an l 1 l 5 opportunity to do that, or are there further questions that I i l 6 we need to ask at this time? 7 DR. FAIRHURST: I would just like one point of
)
8 clarification. I 3 l l
- 9 MR. HALUS
- 'Please.
10 DR. FAIRHURST: I think -- let's say I have got 11 your message anyway. I wasn't here unfortunately, but 12 apparently Dr. Land yesterday gave a statistical assessment 13 and what I heard was sort of the statistical impossibility 14 of extrapolating very low doses with obviously concurrent 15 very, very large. populations. And then I heard somebody 16 say, well, you expect you will get a result supporting LNT, I 17 more or less, if you use one-sided P values. Is this your 18 position? I mean the position that if you included the data 19 that you have and had a totally independent statistical j 20 assessment of that, you would see a threshold? Is that what 21 I am hearing? 22- MR.-MUCKERLEIDE: Yes, I think that is correct. 23 MR. HALUS: Are there any further questions from 24 the committee? Is there another presenter that would like 25 to make comments? l ANN RILEY & ASSOCIATES, LTD. ) Court Reporters f (Q_/ '1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 i L i
336 1- MR. ROCKWELL: Could I point out that Ted Quinn,
'[ 2 the President of the American Nuclear Society, did make it. )
3 'I don't know when his plane has got to leave, but if he 4 could talk now, I think that would be appreciated.
'5 MR. QUINN: I would very much like to speak. I 6 DR. GARRICK: Okay. Please. Please.take the time 7- now, Ted, to go ahead and address -- if you would, step to 8 the. front and put on a microphone.
9 MR. QUINN: Good morning, Mr. Chairman. Good 10 morning,. panel. I am pleased to come before you for just a 11 few minutes to represent the American Nuclear Society. I 12 have a number of messages from the American Nuclear Society, 13 and then I have a couple from myself. 1 14 The first is I thank you for a couple of minutes ( ) 15 to have the chance to come before you. I would like to i l 16 recognize that I believe today you have a very istinguished I 17 panel sitting at the table, with the experie- 'nd 18 credentials that can address this position. i 19 The position of the American Nuclear Society is 20- this is a very serious issue, and I am proud that the ACNW 21~ has taken it on the table to address it. It affects the l 22 ' future of our nation, it affects the future of how we 23 perform everything in nuclear science and technology, and I l 24 believe'you at the' table,'and with the input from these 25 ' experts that have provided it, are well qualified to address ANN RILEY & ASSOCIATES, LTD. I s, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
337 1 it. (~') 2 The ANS is developing a public policy statement on \J 3 the issue of the effects of low level radiation. We are not 4 ready to release it yet, we are still in the works of 5 developing the policy, but I think it has elements in that 6 have a short-term and a long-term nature to it. 7 The long-term nature addresses the importance of 8 molecular studies in science, as has been proposed by the 9 DOE, and is working through. And I believe those studies 10 have great potential in the long-term to address the issues 11 that are so critical to us -- whether there is a threshold, 12 what is the process of cell reconstruction to support the 13 resistance from toxicity, resistance from radiation, 14 resistance from any other cell damage mechanisms? And I am i (nA ,) 15 very pleased with that long-term progress and the fact that 16 DOE is funding. We certainly support continued DOE funding 17 to make this work. 18 In the short run, I think this group, and I think 19 our nation has a responsibility to develop limits that are 20 fair and equitable. 21 Now, I would like to step out and say what is my 22 own personal opinion. My own personal opinion is that the 23 limits of 100 millirem are fair. I believe the statement of 24 the Health Physics Society, and I support it myself, is very 25 fair and equitable. And that is all I am prepared to say, /~' ANN RILEY & ASSOCIATES, LTD. (ss Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I
I' 338 1 ~Mr. Chairman. () 2; 3' DR. GARRICK: MR. HALUS: Thank you. Do we have any questions from the 4 committee? 5 DR. GARRICK: Ted, when do you expect the policy 6- statement to be finished? 7 MR. QUINN: I would say within the next three 8 weeks. 9 DR. GARRICK: Is there anything you can say about? 10 Pardon? 11 DR. FAIRHURST: I was just surprised that it would 12 be available so quickly. 13 MR. QUINN: We have been working on it for over a 14 -year, and it is such an important subject, and somewhat
- y ,/ 15 controversial, that it takes that long for us. And I 16 apologize that we didn't have it to present to you today, 17' DR. GARRICK: Yes.
18 MR. QUINN: What does it say? The thrust of it, 19 again, it addresses the importance of molecular science. As 20 we go down the road, it is critical to us that the human 21 genome and other issues that are doing so great in the 22 technology of.the future have the potential to go in and 23 address a threshold level in a scientific approach for 24 molecular science. That doesn't in a way denigrate or take
.25. away from some of the other studies that are occurring, have ~
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1 f 339 l 1 occurred in the past, to provide you with data from a 2 scientific approach that can give an earlier answer. But I 3 believe in the long run, those studies are critical. l 4 DR. POWERS: How did you arrive at 100 millirem j 5 was fair and equitable? It just seemed like a good idea or 6 -- l 7 MR. QUINN: I believe the current -- and this is, 8 again, what I believe and not what is a position of the l 9 American Nuclear Society. 10 DR. POWERS: I understand. How did you come up, I 11 arrive at 100, not 200, not 50? 12 MR. QUINN: I am a power plant engineer, and I 13 spend all tny time and days in the power plants. I am not a 14 ' molecular I:cientist or a health physicist. I would say my 15 belief is based on the people that work for me, or out there 16 in'the field that have stated -- or the position of the 17 Health Physics Society and others that have stated that 18 experts believe_this is a fair and equitable limit. I can't 19 tell you myself, based on any personal experience, other 20 than that. 21 DR. POWERS: You are in the same position I am. 22 MR. QUINN: Okay, sir. 23~ DR. POWERS: Have to believe the experts. 24~ MR.-QUINN: Yes, sir. 25 'DR. POWERS: But the' experts have been called into ANN RILEY & ASSOCIATES, L'1D. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C.. 20036 (202) 842-0034
1 l 340 l l 1 question here. (') l \m /
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2 MR. QUINN: Okay. Well, I will reinforce the 3 importance of this particular group. It is an enormously 4 serious question, and I am very proud that your grouo is 5 taking a straightforward approach and looking at .-. It is 6 critical to our future. 7 MR. HALUS: Other questions from the committee? 8 DR. WYMER: We do want to thank you for making the 9 effort to get here. 10 MR. QUINN: Yes, sir. 11 DR. WYMER: Through a difficult traffic situation 12 and probably other problems. 13 MR. QUINN: It is, but the importance is that you 14 are looking at it, not me. The importance is that you are
/~N
( ) 15 doing this, and there are 250,000 people or more out there 16 in the industry that depend on your deliberations. So I 17 look very much forward to the results of your deliberations 18 and I hope that all the scientists that you need to help
.19 support this provide input to you in an appropriate manner.
Kim and Otto, do either of you have 1 20 MR. HALUd: 21 questions? 22 DR. RAABE: I have a question, Ted. The Health 23 Physics Society came out a couple of years ago with the 24 position statement, " Radiation Risk in Perspective." I am 25 sure you are familiar with it.
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1 L 341 1 MR. QUINN.: yes. 2 DR. RAABE: Basically saying that there is no 3 basis for quantifying' risk below an exposure of 5 rem or a 4 lifetime exposure of 10 rem, but that we don't have any 5 mechanism for quantifying it.
]
l 6 MR. QUINN: Okay. 7 DR. RAABE: What is the position of the American 8 Nuclear Society.with respect to this position statement? 9 Has the Society discussed it in any way, -- 10 MR. QUINN: Yes. 11 DR. RAABE: -- or do you have something to say 12 about it? { 13 MR. QUINN: Okay. It provides great input to the 14 development of our public policy statement on the effects of () 15 low level radiation, we refer to it in there. The issue is 16 we haven't signed it yet today. So when you ask me what is il
\
17 the position, it is in advance of my ability to say, Dr. i 18 Raabe, and the committee, .that this is the position of the l 19 American Nuclear Society. I spoke to my own experience and 20 not --
.21 DR. RAABE: I guess what I am asking, do you see 22 anything on the horizon that would suggest that the American 23 Nuclear Society would-contradict this or go with this?
24 MR. QUINN: No , absolutely not. No. l 25 .DR. POWERS: What is the position statement O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025. Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034
I . 1 342 ! I supposed to accomplish? ' [~D 2 MR. QUINN: Good question. You are asking good l (._) { 3 questions. The issue of the position statement is that 4 today, in the scientific community, there is a tremendous 5 amount of discourse in addressing this particular issue. 6 And I suppose maybe I could personally say the data of that i 1 7 discourse, is I have had experts within the American Nuclear 8 Society working overnight, many nights to address the 9 development of a public policy statement in this issue, and I 10 some even present have spent that. And the issue becomes it 11 is significant, it requires, on the behalf of scientific 12 societies, a scientific approach. 13 If I was a representative of a trade association i 14 or -- I mean I would take a different position relative. A 15 But we believe that the scientific community can provide t'L) 16 answers, and that there's two parts to it. From the 17 Wingspread Conference results, I am sure you are all much 18 more familiar with that than I am, there are two 19 responsibilities in our country we saw, that scientists that 20 support this committee and others come up with a scientific 21 solution, and that the public policy arena address the issue 22 of setting up appropriate standards, and that the public is 23 made aware of those appropriate standards. All of those j 24 issues are addressed in our public policy statement, sir. I 25 MR. HALUS: Any further questions?
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343 1 [No response.] [ 2 MR. HALUS: Thank you for your comments. 3 MR. QUINN: I would like to thank you again, Mr. 4 Chairman, and the committee for this time. 5 DR. GARRICK: Thank you. 6 MR. MUCKERHEIDE: Can I just make a comments about 7 Ted's -- and stay there, Ted, so you can adjust this if I 8 misspeak at all. Having worked from the perspective of the 9 Chairman of the Low Level Radiation Health Effects 10 Subcommittee at the ANS, my sense of where we were driving 11 over the last four or five years is that we are not -- we, 12 the ANS, speaking now, are not the experts, and signing on 13 to the Health Physics Society statement was not something 14 that the ANS, through its own Society, its own wisdom, if '(v ) 15 you will, as the engineering and technology people, could or 16 should really do. 17 Our issue is the debate is strenuous, it tends to 18 not get recognized very much, and it must be addressed by 19 our institutions. And I think, you know, reading into all 20 of that, you have got to accept that, in one sense, the ANS 21 can't make a scientific decision on this because it is 22 really up to the Health Physics Society, the Radiation l 23 Research Society and others where that debate goes on. On I 1 24 the other hand, the emphasis we have had is we can't let the 25 institutions continue to set it aside it or ignore it. We l
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I f5 344 1 have to urge that-it be undertaken in a serious scientific 2 vein'and not just as a matter of policy. 3 MR. HALUS: Thank you for your comment. Are there
- 4 other presentations that people would like to make from the 5 floor? .I guess we have another one coming up now.
6 DR. POLLYCOVE: Well, again I appreciate the 7 ' opportunity to make essentially a couple of comments about l 8 the future and what should be done. 9 First I would like to address the question of the 10- molecular biology and the models and so forth. I think that
- 11 this is very important because I believe that much of the l
12 resistance to departing from LNT is stated very, very l 13 explicitly in the NCRP Report 121. They have a biophysical 14 presumption. They know that the damage done to DNA is 15 proportional to the radiation it receives, whether it's low i 16 LET or high LET. They know that that damage isn't all 17 repaired, and therefore proceed to the conclusion that there i 18 must be an incremental risk for all amounts of radiation. 19 Again, they state it in a very succinct and j 20- truthful manner, and I don't disagree with any of the 21 -statements that I made so far. That's all true. And Ted' 22- read this yesterday. So.that any of these effects as due to L23 radiation of cancer, suppressor genes and oncogenes being ! 24' expressed and so forth, any of these effects could result 25 from the passage of a single charged particle causing damage ANN RILEY & ASSOCIATES, LTD. Os Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
345 1 to DNA, and we know that damage is proportional, that could 2 be expressed as a mutation or small deletion. - [ g' i
- 3 It's the result of this type of reasoning that a j I
4 linear nonthreshold response relationship cannot be ' 5 excluded. When you have that firmly in the back of your 6 mind, you're going to view all evidence that supports this 7 view as being scientifically correct and all evidence that 8 contradicts this as being some hidden flaw in it, there's 9 something wrong, because this is -- how can_this be right l 10 and how can that be right at the same time? 11 Now, it is this presumption -- and I use the word 12 " presumption" correctly -- it is this presumption that as a 13 result of this type of reasoning, that a linear nonthreshold 14 dose-response relationship cannot be excluded, it is this t'N
- ()
15 presumption based on biophysical concepts -- and again, it's i l 16 absolutely true -- it's based on biophysical concepts, not l 17 biological concepts, not on an intact organism responding 18 with homeostatic principles. This is -- I could not -- this 19 is absolutely correct. It is this presumption based on 20 biophy'ical concepts which provides a basis for the use of 21 collective dose in radiation protection activities. 22 Now how can you justify any more strongly the 23 necessity for molecular biological models based on biology i 24 to explore this and find out indeed if linear damage to DNA l l 25 is translated into a linear risk to the organism. This is I ANN RILEY & ASSOCIATES, LTD. f~)/
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I I 346 L 1 exactly this question that is so valuable to the DOE effort t i /' 2 now. i 3 Now that doesn't mean that one should then exclude 4 epidemiologic evidence that contradicts LNT. There's been a 5 great chorus of support. We don't want any more of ! 6 epidemiologic studies like Cohen. We don't know what's 7 wrong with it, but it must be wrong. We don't know what's 8 wrong with the nuclear shipyard worker, but there must be 9 some mismatch in the controls, et cetera, et cetera, et 10 cetera. 1 11 Well, I think that if a model, a biological model 12 that can explain how at the same time you can have damage 1 13 that's proportional to radiation, and you see, even if you l 14 repair the damage in a constant way, and that's admitted, 1 /~h l(d' 15 let's say 99 percent of the damage is repaired or 10 to the " l 16 minus 6 is all that's left over, only one part in a million 17 remains, still this concept is absolutely correct. If you 18 have a constant repair of the damage, then LNT follows as 19 night tne day. 20 So we have to go to the molecular biology, and 21 it's for this reason that I began about a year and a half 22 ago to work on a biological model. And it was for this 23 reason that we pulled together international experts in a l l 24 meeting in Berkeley to which Marv Frazier referred in June 25 of last year to discuss this whole topic, including I l
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347 1 endogenous damage. There's no endogenous damage, and it's l [~') 2 not affected in any way except in a constant manner by V 3 the -- still it's LNT. So the endogenous damage has to be 4 taken into account, and these adaptive responses have to be 5 taken into account, and show the great high probability that 6 the3e mechanisms of prevention, repair, and removal operate 7 on the endogenous damage as well as the radiation damage. 8 And from an evolutionary standpoint this makes sense. 9 At any rate, so on this basis that the model was 10 developed that Marv Frazier felt was if all the experts can 11 agree, and these include experts on radiation damage, if all 12 the experts on damage and repair and so forth can agree on j 13 the model, then this furnishes a basis for targeted research l 14 to see if some of the assumptions in the model based on what n [a\ 15 we know now indeed are valid or whether they need to be 16 modified and so forth. So this is really why I think this 17 molecular biological research is so important, because we 18 have to see whether this biophysical presumption actually 19 materializes as a correct biological function. 20 Okay. Now there are many points in the NRC report 21 that I think demonstrate -- how shall I put it? -- the lack 22 of impartial treatment of both sides of the issue. And to 23 focus on one only, with the time that's available, I would 24 like to just focus on Bernie Cohen's work, because Evan 25 Douple referred to that that the BEIR VI committee gave it ANN RILEY & ASSOCIATES, LTD. x ,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ( Washington, D.C. 20036 ! (202) 842-0034 l l
p 348 1 1 great attention, spent a great deal of time, in fact there 2 was even a BEIR VI workshop that we had for two days in 3 preparation for dealing with Bernie's data. So it did get a 4 great' deal of attention, and was dealt with specifically in 5 the BEIR VI report. It was also dealt with specifically in 6 the NCRP report which came out about a year later after the 7 BEIR VI report. 8 Now from the -- and I'll' distribute this letter -- 9 from the Central Laboratory for Radiologic Protection, the 10 director, Dr. Stavomir Sterlinsky, wrote this letter to Dr. 11 Meinhold, and he thinks that this report is very important 12 and'certainly deserves an in-depth reviewing. However, we 13 received it relatively late and time limits restrict us to 14 only a few comments. () 15 And I will only excerpt the comments that he 16 makes, and then show the data which was shown in the BEIR VI 17 report which Evan Douple put on the screen yesterday and 18 contrast that data which was shown as a justification for 19 discarding Bernie Cohen's data with Bernie Cohen's own data 20 in his'own report, which they refer to. All right. . 21 Now, general comments. Papers quoting as 22 supporting LNT often contain data to the contrary, and 23 evidence against LNT.is often downplayed. Ecological 24 studies and epidemiology cannot be regarded as trustworthy 25 and should not be relied upon to study low-dose effects -- O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036' l (202) 642-0034
349 1 page 156. If they provide evidence against LNT, e.g., 2- Cohen, 1995, yet they are acceptable otherwise -- and 3 specifically Dimidchik et al., 1996, on page 180. i 4 Page 154 to 156, ecological studies, this is an 5 exceptionally biased discussion -- now maybe biased is a 6 harsa word, Otto,'but he uses it anyway -- i l 7 [ Laughter.] L 8 In which the arguments of only one side are 9 -presented. Cohen, 1995 study demonstrates LNT predictions ( 10 of lung cancer mortality due to residential radon -- and 11 this is all-Bernie claimed -- is not confirmed by 12 epidemiology. He says I'm not trying to prove hormesis or 13 anything else, I'm just saying that.the predictions that are 14 me9a _by the mine workers study and EPA are not confirmed () 15, 16 when you actually go out in the. field and see what goes on. 1 Now, so, in this chapter five papers are cited in 17 support of statements that ecological studies such as 18 performed by Cohen are. intrinsically biased. Cohen refuted 19 most of these arguments in his publications, none of which 20 were even mentioned here. In other words, they don't cite 21 the Cohen responses to these criticisms. l' 22. A' striking example of the biased treatment of this 23 subject is at the paper of Lubin, 1998, in which Cohen's 24 work is criticized, is cited here twice. However, the 25 arguments from Cohen's reply in the same issue of Health O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
E j 350 1 Physics, pages 18 to 23, and information that the so-called () 2 Lubin's effect contributes very little to the huge 3 discrepancy between Cohen's data and LNT predictions, and 1 4 offers no plausible explanation of this discrepancy, are not l 5 presented. 6 A similar biased treatment of the available j 7 information is continued on page 107, lines 1, 2, 3, 4, 15, 8 17, 18. 9 On page 158 -- sorry, that has to do with the atom 10 bombs in Japan. Let's continue with the Cohen. Here we 11 are. 12 MR. MUCKERHEIDE: Page 197. 13 DR. POLLYCOVE: On page 189 again this has to do 14 with lung cancer and cigarettes and downplaying. All right, () 15 here we go. Page 193-197. This is a continuation of an
- 16 attack on Cohen. Study demonstrating that residential radon 17 cannot practically be a causal factor for any lung cancers 18 in the United States. In this attempt to disqualify the 19 methodically meticulous work of Cohen four papers are cited 20 here. Cohen responded to this criticism, refuting most of 21 the arguments against his work, and he cites the Cohen and 22 Colditz, '94, Health Physics '64 '65, your reference Cohen 23 '95, Cohen '97, Cohen '98, Health Physics 7518, Cohen, ibid, 24 page 23, Cohen '97, Health Physics -- none of these Cohen l
25 papers are even mentioned. A statement on page 197, line [^}
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351 ) 1 28, the results of Cohen's study cannot be relied upon (g)
%J 2 should perhaps end with "because it does not support LNT."
3 [ Laughter.) 4 This is another example of a biased approach to 5 NCRP SE 16 report. 6 Now let's look at the slide that Evan Douple -- 7 here we are -- in the front, here we go, good -- showed 8 yesterday. 9 MR. HALUS: We have about five minutes remaining. ; 10 DR. POLLYCOVE: Okay. This will be very quick. 11 I want to point out that the bars are shown on the 12 cohort studies. The cohort study shown -- the average in a 13 solid line, the mean of about 9 cohort studies, that solid , 14 line. You can see the points and you can see the bars on l (v) 15 it. And then below it we have this sort of figment of the 16 imagination, misplotted, the points should go through those l 17 lines, so it looks steeper and more ridiculous than it l 18 really is, and no bars, no bars at all. 19 Now -- oh, thank you. l 20 So anyone looking at this would say well, you 21 know, here's solid data with statistics and here is a 22 fantasy. Well, what actually does this curve'look like? 23 You see how small the bars are. They're very tight. These 24 don't begin to approach no effect, let alone theory. Now 25 perhaps they were annoyed by the fact that the theory is
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l I 352 1 shown in the dotted line.
~D 2
[G [ Laughter.] f 3 But there are no points up there. There are no 4 bars up there. So they said well, we'll do the same thing 5 to Bernie. But Bernie has very tight, very tight. It's 6 very interesting to note that from four picocuries per liter 7 on how big the bars get. Of course, the reason for that, , 1 8 there relatively few homes that have that high radon j 1 i 9 concentration. And that explains exactly why EPA set 10 this -- there's no scientific basis for setting the remedial I i i 11 level at four picocuries per liter. No, you set it where 12 you're going to get the least public resistance. No l l 13 science.
]
{ 14 DR. RAABE: Myron? '
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t 15 DR. POLLYCOVE: Yes, s_.) 16 DR. RAABE: Can I say something about this. 17 DR, POLLYCOVE: Sure. )
)
1 18 DR. RAABE: While you have it up here? ! 19 Myron and I participated in the hearing for the 20 NCRP committee meeting, and we were both present when Bernie 21 Cohen presented this to the committee, and Jay Lubin got up I 22 and criticized it. And what it really came down to, Jay 23 Lubin, who is really the author of this BEIR VI model, he 24 gave a very, very strong condemnation of the whole 25 methodology from a mathematical basis. It appeared to be I
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l 353 q
.1. quite a rigorous mathematical derivation, with lots of
'"N 2 equations on the board.
'U 1 3 That went through because this being an ecological j 4 study, Bernie Cohen did not know the dose to anybody. All 5 he knows.is the average concentration in homes in these 6 counties, so no particular person's exposure is known. L Okay, so this is what you call an ecological study 8 for that reason. Now what Lupin did, he convinced the 9 committee from a mathematical argument that if there were a 10 presumed unknown cross-level confounder, mathematically the 11- slope of this line could be anything, and the committee 12 accepted that. l-13 DR. POLLYCOVE: I know. 14 DR. RAABE: That's what it comes down to. You ! 1 () 15 were there. J DR. POLLYCOVE: Yes, I was there. ; 17 DR. RAABE: It was a devastating presentation. He 18 took 30 minutes to condemn this methodology -- 19 DR. POLLYCOVE: But it was on a theoretical basis 20 and Cohen's response to that and show that even if that were l 21 true and the smoking were completely inversely related to ! i 22 the radon concentration -- in other words, you had more 23 radon, the less smoking -- it still wouldn't bring it up to 24 the horizontal. 25- DR..RAABE: The point I wanted to make though is p/ .- ANN RILEY & ASSOCIATES, LTD. (_s Court Reporters 1 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 354 1 that the committee heard both sides and they made a decision j l
~'T 2 to accept Lubin's argument. Now I don't personally accept (O I 3 it but I don't see the committee as having some sort of i i
4 sinister type of reason for rejecting it. l 5 They accepted the Lubin argument and it was a very 6 strong, well-presented argument so when the committee sat 7 down to go over it, the way I look at it, they said, well, 8 if Lubin is right, then Cohen's slope is meaningless, 9 because that's what Lubin said. 10 DR. POLLYCOVE: Then what is the point of not 11 plotting Bernie Cohen's curve correctly and dropping the 12 bars and all of that? That has nothing to do with theory. 13 That has to do with scientific integrity. That is my point. j 14 It's not a linear model. () 15 DR. HORNBERGER: Put that back up there. That's 16 an exponential model? 17 DR. POLLYCOVE: No -- 18 DR. HORNBERGER: Plotted on semilog. 19 DR. POLLYCOVE: This is plotted on semilog, right. 20 DR. HOR'.JBERGER : That's an exponential model. 21 DR. POLLYCOVE: Right, right. 22 DR. HORNBERGER: It's not linear -- it's not a 23 linear no threshold model. l l 24 DR. POLLYCOVE: No , that's right. I 25 DR. HORNBERGER: Just a point of clarification l l ANN RILEY & ASSOCIATES, LTD. f] ( ,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L
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355 1 when you have that up there. l?() v 2 DR. POLLYCOVE: Oh , sure. DR. HORNBERGER: I think I know the answer but -- 4 DR. POLLYCOVE: Right. 5 DR. HORNBERGER: Are the indoor studies and the ! J 6 miner studies -- I assume that they are also corrected for ! 7 smoking? l 8 DR. POLLYCOVE: Yes, presumably, although you sees. 9' the smoking of the miners I don't know how that was ' l 10 . objectively determined. In fact, I don't even know how the l 1 11 exposure of the miners was objectively determined. ; 12 Many of these miners were people who worked 16
- 13. = hours shifts, although they only considered 8-hour exposures 14 every day they worked, and some of them slept overnight in l) 15 corners which had enormous stasis and collection of radon, l
16 so that the dosimetry of the miners study was far worse than 1 17 the dosimetry on the counties where they actually measured ! l 18 the residential, average residential radon exposure in the 19 homes and assumed they were in so many hours a day, and even 20 'the ones where they did individual and the case control
-21 studies, there was no telling exactly how many hours each 22 member of the household spent in and out of doors so that 23 the exact dosimetry was very difficult, but it was ,
24 particularly loose in the miners.
.25 DR. HORNBERGER: Yes, well, one of the reasons I i / ANN RILEY & ASSOCIATES, LTD.
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-356 1 asked -- as you know, I am not an expert -- )
2 DR. POLLYCOVE: ks/ )' Right. l 3 DR. HORNBERGER: -- but I served on a committee 4 'with somebody who did some of these. miner studies and I 5 recall, I may be recalling incorrectly, but I recall him 6 telling me-that it was a very, very strong correlation with 7- smoking, that basically -- 8 DR. POLLYCOVE: Oh, yes. j 9 DR. HORNBERGER: -- basically that miners who did 10 not smoke basically were not affected by the radon 11 exposures. 1 12 DR. POLLYCOVE: That's right. In fact, that was 13 the response of the BEIR VI committee when they were asked, 14' well have you checked the radon in you home? The only one 15 that responded -- everybody stonewalled on it except Roger 16 McClelland, and he said well, no , I didn't check it but I ) 17 don't smoke so it doesn't make any difference. 18 DR. WYMER: Do we have other questions about the 19 presentation? 20 DR. RAABE: Just one comment on this one. Those 21- so-called datapoints are not actunLly data. They are the 22 result of a very complicated, maximum likelihood logistic -- 23 as Charles Land described to us yesterday and those are the i 1 24 estimated means and the standard -- and the 95 percent l 25 confidence' range for those means. I ANN RILEY & ASSOCIATES, LTD.
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I-357 1 The actual data, which I-have'here, is a scatter ,N O -2 plot. [ usl l l 3 DR. POLLYCOVE: Right. I 4 DR. RAABE: It's a scatter plot, okay? So this is ) l 5 generated by a computer program with a log linear model and. 6' it is anchored at the zero dose point. There is no zero l 7 dose point. That was created by the computer. ;
}
! 8 DR. POLLYCOVE: Right. 9 DR. RAABE: Now if I.would suggest that that zero 10 dose point which creates the relative risk of one was off by 11 just 10 percent, you can suddenly'get a straight line across 12 there that has no dose response relationship at.all, so 13 there'is a lot of things going on in this -- 14 DR. POLLYCOVE: Right, and even these, every one ( f')% 15 crosses the no effect line. 16 DR. RAABE: I have to make one more comment and 17 that is I did my doctoral research on radon in the '60s. I 18 think I know something about 'c. Now these crse centrol 19 studies, yes, they correct for smoking because they matcP l 1 20 the case control so that they have smokers, but how would 21 the figure out the dose to radon over the lifetime of these 22 people?
=
.23 Now I studied radon, you know, and I know a lot 24l about it I do not think I could estimate my personal 25 lifetime radon dose. Now can they get it by looking at I
I t [~)
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358 l' somebody's home where they happen to live at a certain time? 2 It is a very difficult problem, to get these doses, so there ' V[~T 3 .is a tremendous uncertainty in the doses and there is the l 4 structure of the regression -- so'there are real questions. 5 DR. POWERS: You were persuading me that the 6 argument that the slope of the line could be anything is
- 7 essentially true. I don't think that either study proves 8 anything anyway.
9 DR. POLLYCOVE: Well, this study shows that the 4
.10 predictions of EPA that if you live in a high radon 11 residence that you have more chance of having lung is 12 incorrect, and that is all Bernie Cohen claimed, that 13 they -- with tremendous statistical power hc showed that 14 people who. live in homes with higher concentration of radon
'() 15- hasa'losu .isk of cance. 'ren . sing the'same correctior. for 16 ' smoking that the BEIR IV a r.1 L.3 SF1k er - 'e and even if you 17 assumed that there was an inverse relationship a still 18 co;'.dn't get this line to be horizontal. That is what he ! 19 showed. 20 DR. WYMER: Kim, did you have a question you l 21' wanted to ask? I l 22 DR. KEARFOTT: No. ! i 23' DR. POWERS: It strikes me it is of limited 24 predictive value -- that is, I would not reduce my rate of 25 lung cancer by injecting. radon into my house. I have to i i ()
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359 1 inject in radon plus engage-in all of the other activities
, 2 that might affect my --
3 DR. POLLYCOVE: Well, all the other activities you 4 can think of -- lus has expanded this to 150 socio-economic 5 factors and shown how each of these will change the slope, 6 and none of them got to zero, and they flip-flopped around 1 7 the average, and when you take 90 percent of the population, , I 8 these other factors will bend one way or another but 9 statistically the only way you can get this kind of effect, 10 -and as I said this was not only seen by Bernie but seen by many others. 11-} 12' In fact, let me tell you how objective Bernie was. 13 For the first few years that he was looking into this, he 14 believed that radon produced cancer. He installed a () 15 ventilation unit in his home. He got rid'of the stuff out 16 of'his basement, but by the time the data piled up into the 17 '90s he turned'the switch off. 18 -[ Laughter.] 19 MR. HALUS: ' Chairman, I believe you had a 20 question. 21 DR GARRICK: Yes. Before Myron leaves, I want to i 22 ask him one overarching question. ; 23 Given what we have heard.the last two days, and 24 assutne for the moment that you are the ACNW, what single l 25 recommendation'do you think would best reflect -- what [)' (, ANN EILEY & ASSOCIATES, LTD. Court Reporters 1025-Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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v- ; i 360 1 single recommendation to-the Commission would best reflect
.O 2- what we have learned?
i
.-Q
-3 DR.'POLLYCOVE: Well --
4 DR. GARRICK: If you want to make two, that's
- 5. okay. ;
1 ! 6' DR. POLLYCOVE: Well, first of all, I would say I' 7 that we learned'that -- in my own personal opinion -- we I 8 have learned that there are tremendous biases built in ! 9 because of the focus on radiation damage and the l 10 acknowledgement that for all practical purposes -- this is a I 11 little slight change -- but for all practical purposes that 12 radiation damage of DNA indeed is proportional to the amount 13 of radiation, period, and because of this firm concept, as 14 stated in their own NCRP publication, they feel that it is ( 15 j illogical even though they don't have any data, they say 16 they have no data to support it and some data contradicting 17 it with high statistical power, it's all admitted in that 18 one summary, nevertheless that this has to be adhered to, 19 and so therefore this report demonstrates this bias. 20 They want to stay with what they understand, with 21 what is clear and~ logical, and what supports that they 22 highlight and what does not support it it must be flawed, 23 and they tend to -- so it is not an impartial, because there 24 is this. strong basis not being impartial. 25 Okay. So what I think is needed is, as was O
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361 1 suggested yesterday, is to have an entity, and perhaps the 2 Surgeon-General is not the best but on first blush it would 3 seem that-here's somebody that is impartial, that can get a 4 group of scientists that have not been identified. In other 5 words, even though these people are expert, they should not 6 be included because they'have demonstrated repeatedly that 7 they are going to cling to this central viewpoint -- people 8 that are more biologically oriented, that have not been 9 a';sociated with the radiological protection. 10 As pointed out, recently it came to my. attention 11 'that in Japan there's a study that has been going on for 12 over six years. In the first three years they gave 13 tritiated water for a lifetime to mice and showed indeed 14 that there was a great increase in cancer as the dose went () 15 up. Then after they did that study, they went to very low 16- doses, by-low doses meaning about in the order of 100 mr per 17 day, which is low dose. That is what we get in a year these 18 mice got in a. day. They showed that at these very low doses 19 that cumulative, over a lifetime, these mice showed marked 20 decreases in cancer.. For instance, all cancers were. reduced 21' to 40 percent of the controls and with a P value of .0007. 22 Now that study was not cited in the NCRP report l' 23 and yet another study, another revision by Jeffrey Howe, the
'24 Canadian breath fluoroscopy study, was cited even though it 25 hasn't.been published and it was cited as being published in
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t 362
'l 1998 in'the American Journal of Epidemiology, and hasn't
() 2 3 been published yet in 1998, so'they reach every shred of
' data that they feel can invalidate the Canadian breast 4 fluoroscopy study.
5 -I am just saying that because of clinging to this 6 point of view that you need to get people who have not been 7 familiar and active in this and perhaps selected by somebody 8 that is impartial and scientific from the biologic community 9 and not the radiation protection community. 10 DR. GARRICK: So basically the recommendation 11 would be because of biases in the NRCP report we need 12 another study? 13 DR. POLLYCOVE: Right, right. 14 DR. GARRICK: And it should be biologically based 15 rather than -- 16 DR. POLLYCOVE: That's right. 17 DR. POWERS: I guess I am struggling with what 18 that accomplishes. You would have a bunch of studies over 19 here, and I find your arguments on the biophysical very 20 persuasive -- if I have that mindset then linear follows as 21 night follows day -- and then on the other hand I find l 22 persuasive also the arguments that say cells in petri dish 23 don't have the full amino and biological response and so the 24 biological thing could give you a different model and in 25 fact I have been fiddling around -- can I create a model t ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 I (202) 842-0034
I 363
.1-~ that does something here?. Stay tuned.
1 l-f 2 DR.-POLLYCOVE: Well, we hope it will be published 3 this year in either the National Academy of Science or 4 Sciance so we will have something out front. L 5 DR. POWERS: But here is the problem I see is that 6 now I've got ther study that says now things go not 7 linear. C rn Jo I stop there? 8 L_. e LYCOVE: No. 9 DR. POWERS: I got to get in another study that 10 doesn't have the prejudice that's there. I have got more 11 and more studies.
-12 DR. POLLYCOVE: Well, it's not a prejudice. If 13- you gave tritiated water to mice in varying doses, and you 14 just find out what happens, and you find out that at the
/}
( ,f 15 high -- they did the high dose studies first and they found 16 out that indeed the cancer increased proportional to the 17 dose and lifespan was shortened proportional to the dose, 18 and when they went to the lower dose tritiated water study 19 for a lifetime, they found that they lived longar and they 20 had less cancer. 21 Now I don't see why that is prejudicial. 22 MR. HALUS: Okay -- do we have further questions 23 from the panel? 24 DR. POWERS: Well, I would still like to 25 understand how having this study helps. I mean it seems to ANN RILEY & ASSOCIATES, LTD. k')-( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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o 1 il . 364 l 1- me the far bigger help is to have, y a , a model that doesn't 2- have this biophysical basis on it -- 3 DR. POLLYCOVE: I agree.
-4 DR. POWERS: -- and say here are the experiments 5 one can do that would say yes or no.
6 DR. POLLYCOVE: Precisely. That is where I l 7 started. 8 DR. POWERS: I think that is a far more valuable 9 recommendation to you than yet another study with a : 10 different group of people. 11 DR. POLLYCOVE: It's hard to understand, it is 12 hard to accept things that you don't understand. In fact, 13 your understanding contradicts those results. It is hard to 14 accept that. I
/T 15 MR. HALUS: Are there other questions or comments?
. Q 16 DR. RAABE: Just one quick comment. I think the 17 committee is starting to get the feeling here that nobody ; i l l 18' really understands the mechanisms by which radiation 19 produces cancer. If they did, they would get the Nobel , 20 Prize, so they're all guessing. We all know DNA is involved l l 21 but cells are involved, tissue, organ systems, cells talk to I 22 each other. Nobody really knows all the pieces and so this 23 is.why there is such a disagreement in the scientific 24 community and if someone is concentrnting on the biophysical 25 piece, then they will project that and say well, this O ,- ANN RILEY & ASSOCIATES, LTD.
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365 1 represents it. I\ 2 Also, the things that are published are not all of U 3 equal quality. I 4 And I have looked at a lot of papers that 5 supposedly show things, maybe it is a mouse study -- I l 1 6 didn't look at this cae, all right -- but I go in there and ' 7 look, as a researcher who has worked with animals,.and I 8 know there are real serious problems in how you set up your 9 controls in these experiments. And I look at these studies, 10 and I have talked to people, and I say, my goodness, they l 11 could get any result they wanted by misrepresenting the 1 12 controls, you know. I 13 And one laboratory actually took a bunch of mice 14 that came in and exposed the first batch to the radiation, {
/s (s_j 15 and then they wanted some controls, so they ordered another I l
16 batch, and those were the controls. That was actually l 1; reported at a national meeting. And they found hormesis, 18 believe it or not. 19 Now, I am not saying that represents all.-- I am 20 just saying each study has to be looked at very carefully. 21 And, also, when a scientist looks at these studies and sees 22 an observation that disagrees with his, perhaps his model-23 that he has, based on other work that he has done, he also 24 realizes that there are chance observations that occur in
- 25 studies that may agree or disagree, and the standard of i
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366 1 acceptance is always going to be higher for some unusual 2 results, results you consider to be unusual. [')} 3 If I send up -- some of my papers, I have trouble 4 getting published because some of my results are unusual. 5 But the standard is higher in science. Scientists say, 6 well, you got an unusual result, you have got a bigger task 7 to prove it. You have to do a lot more. And it is not that 8 you are biased or there is some conspiracy against it, it is 9 just that the bar gets higher if you come up with something 10 that is different and doesn't quite fit the model that 11 everyone is working with. 12 MR. HALUS: Are there other questions for the 13 speaker? 14 MR. MUCKERHEIDE: Can I just ask one question? A (J ! 15 Myron, you pointed out the fact that radiation damage to DNA 16 is linear. 17 DR. POLLYCOVE: Yes. Essentially linear. 18 MR. MUCKERHEIDE: You didn't mention the 19 relationship to the level of background, normal metabolism 20 and whether or not linear would necessarily result in health 21 effects if you are in the large background. Can you just 22 give a little bit on that? 23 DR. POLLYCOVE: Well, I alluded to the fact that 24 if you only consider radiation damage and not the response ( 25 of the organicm to the damage as Ed Calabrese dwelt on I i (~3 (s j ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 j Washington, D.C. 20036 ; (202) 842-0034 l
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l 367 1 . yesterday, then it follows inescapably that if damage is
] 2 . translated one to one into life-shortening and cancer, then 3 it is inexplicable that low doses could have the opposite 4 effect. And it just-turns out that when you take into l 5' account the adaptive _-- I am'sorry, I am not addressing your l 6 question.
7 MR. MUCKERHEIDE: Right. I wanted to put that in i 8 the context of normal oxidative metabolism breaks. 1 9 DR. POLLYCOVE: Okay. Well, yes. Well, I didn't i 10 want to go into the model itself. It turns out that when
-i 11 you look at the amount of damage that is caused by radiation '
12 at low doses, per day, continuous, to the damage that occurs 13 endogenously from the free radicals.that are caused by l 14 oxygen metabolism, it turns out there is an enormous () 15 16. discrepancy, so that even when you take into account that there are 2 percent of the damage that is done by low LET 17 radiation is~-- performs -- results in double-strand breaks, 18 and that only'one in 10 million -- we did a statistical 19 analysis which the radiation damage gurus and these experts 20 agree with, that only one in 10 million of the random damage 21 done by free' radicals produces a double-strand break. 22 There are so many that occur each day that it 23 turns out, surprise, that there are more double-strand 24 breaks, far more double-strand breaks per day from 25 endogenous damage than there is from the low Jevel radiation l l
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l 1 > 368 1 damage, and not in the one in 25 years, and so forth, and so [V ) 2 on, which is just some wild guess, I don't know where that 3 came from. 4 But anyway, I think this is what -- but this is 5 all part and parcel of the model that we are working on, 6 nearing a final draft, and I really don't want to talk about 7 that any more than ANS wanted to talk about the policy, 8 President Quinn wanted to speak about the polico of ANS, ! l 9 until all of us authors, or seven of us, sign off on it and 10 submit it for publication. Once we get to that point, I am 11 willing to talk about it. 12 MR. HALUS: Thank you very much for your comments. 13 Thank you very much for your presentations. Let's go ahead 14 and take a break at this time, say, a 15 minute break. (D 15 DR. WYMER: ( / Yes. And when we come back, then we 16 will go into a discussion of our rcport based on this 17 meeting and the discussion period is essentially over at 18 this point. I 19 MR. ROCKWELL: Can I just make a quick answer to 20 John's very important question about what should you 21 recommend? One, I think that it is important to point out ' 22 that serious questions have been raised about the basis for 23 many of the conclusions in this NCRP, and those should be 24 responded to because the report is not -- should not be ( 25 considered accepted and valid until some of these very { i <. t ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 I (202) 842-0034
369 1 fundamental questions that have been' raised, time and time I () 2 again, and ignored time and time again, are responded to. 3- That would be the first thing that I think is important.
'4 And then, second, whether or not the LNT as a 5 .model is repudiated is less important,.really,.than facing 6 the question of how low down are we going to continue to
-7 insist that we are killing people. The idea that we now say 8 we are killing people at 100 millirem, at 10 millirem, at 1 9 millirem per year, we.have got to face up to that practical 10 question, which is the real burden on us right now. And to 11 .say we don't,know and, therefore,.we are going to assume 12 that we kill people, and actually have the Department of 13 Energy send out a report that says they are going to murder 14 -23 people by shipping shielded casts of rad waste around, as 15 long as we are saying those things, I think we are not in 16 realm'of science, and we are really just killing this 17 industry.
'18 MR. HALUS: Okay. Thank you for the comments. We 19 will take a break at this time. And would you still like to 20 start at half past or 25 till? i l
21 DR. WYMER: Twenty-five till. l 22 MR. HALUS: Okay. We will start 25 till, and that ) 23 concludes the discussion from the floor. Thank you very ) l 24 .much, everyone, for participating. 25 [ Recess.] I I i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I i
l r-370 1 DR. GARRICK: Okay, I guess the meeting should j 2 come to order. Ray, I.think what we want to do now is have i [\_-) 3 a discussion among the committee members, the consultants, i 4' et cetera, on what we have heard and what it means, and see j 5 if we can begin to flush out some of the nuggets that might 6 be the basis for us to make some recommendations to the 1 7 commission. 8 DR. WYMER: That's right. I think we have, both 9 you and I have independently suggested to our consultants 10 that we really want them to do all the work. So I guess we 11 would like to hear, as a starting point, what each of you, 12 in turn, have to say about what might constitute , 13 recommendations and input into a report. ] 14 DR. RAABE: Before we get into that, I wanted to 15 .make.one sort of observation about what we have heard over l 16 the last day-and-a-half. To me, as a radiobiologist, there ! 17 is a big gap and what we have heard. And there is a big gap ) l 18 in what BEIR VII is trying to do, and there is a big gap in 19 l what the NCRP report does, and that gap, I think is crucial. 20 That gap is inadequate treatment of the effects of I 21 protracted radiation. l 22 In fact, I could even justify recommending that we l 23 should have a report where the committee is asked only to 24 look at protracted radiation instead of -- 25 DR. WYMER: Protracted low level or just -- l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 2 84 b34
371 ! 1 DR. RAABE: Protracted, it doesn't make much
) 2 difference whether it is low, you have to put the high level 3 -- as a scientist, you have to put the high level in with 4 the low level to see what the shape of the dose response 5 curve looks like. But protracted radiation, for example, --
6 it is really what we are talking about within the nuclear 7 waste issue, really, internally deposited radionuclides. 8 You heard in the BEIR VII presentation yesterday, 9 'they said, no, we are not going to cover internally 10 deposited radionuclides. So'that means they are going to 11 emphasize the acute high dose rate, atomic bomb survivor 12 studies and other related medical data, and very little -- 13 they won't touch on what probably is the most important 14 issue. () 15 Also, they work with a very simplistic model to 16 take all these analyses they do of acute high level 17 radiation and try to predict what is going to happen from 18 protracted radiation, and the model can be shown easily to 19 be wrong, by looking at actual data on humans and animals 20 with protracted irradiation. 21- So I just see that as a gigantic gap, you know, we 22 just didn't get it. Some people touched on it a little bit, 23 .but only a little bit. And the whole basis of protecting 24- the public with regard to radioactive waste is probably low
=25 doses of radiation protracted in time. And if there is a
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372 1 significant difference in the shape of the dose response
\ 2 curve, then we should know that.
l-(V . 3 Now, I actually have worked for about 20 years in 4 analyzing pIctracted radiation studies from internally 5 deposited radionuclide, looking at about 12 radionuclides, 6 and both high LET and low LET, and I can tell you that from 7 my studies, I always found a very pronounced effective 8- threshold. Very pronounced. 9 Now, that is just, you know, that is my 10 observation of data. But I think the whole point is, if 11 there is a true difference in response, and there is an 12 effective threshold associated with protracted irradiation, 13 we need to pull together the information about protracted 14 irradiation. () 15 16 DR. WYMER: Okay. DR. RAABE: The other one little point, just a 17 technical point that came up a couple of times, and I 18 mentioned it at the very beginning yesterday, and some 19 people asked, well, what did I mean by this? Linear 20 no-threshold has two parts. It has the linear part and the 21 no-threshold part. Now, to some people, when you say there 22 is a threshold model, they think, oh, that means there must 23 be some dose at which the risk is zero. Well, we can prove 24 there is no zero risk because, you know, as Art said 25 yesterday, there are some DNA changes that aren't repaired.
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F-373 1 When I talk about a threshold model, I call it an
} 2 effective threshold model, I just talk about the risk going 3 down_to very low levels. And when I calculate a risk of 10 4 to the minus 20, at some low does, for all practical 5 purposes, I ignore that. It is probably the chance the
! 6 ceiling will fall in this building because some engineer 7 miscalculated some stress on some beam. 8 MS. THOMAS: Don't say that. 9 MR. LARSON: That's 10 to the minus 4. 10 [ Laughter.] 11 DR. RAABE: So, you know, to some people, when you 12 say threshold, they say -- it clicks in their mind, zero, 13, zero risk. Well, I don't know if we can -- we can't find 14 zero risk, and I am not sure we need to. () 15 DR. GARRICK: I like to call that the speed limit 16 mentality. 17 DR. RAABE: And so the other thing -- and if you j 1 18 read -- I read the whole NCRP report and this is a very J 19 important part of the first several sections, that they come 20 to the conclusion that since there are DNA changes that are 21 not repaired, that, obviously, you cannot have a threshold. 22 Now, the linear part is interesting, too, because 23 they.also say, therefore, the linear is the best model. 24 Well, why linear, you know? Curvilinear responses are very 25 common in biological studies. And, so, could it be l
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n-l 374 1 curvilinear'with no-threshold? () -2 So those are all questions that just popped in my 3 mind as things were going on yesterday, f 4 DR. KEARFOTT: I could give a summary of my 5 impressions if you want it. 6 MR. HALUS: That would be great. 7 DR. KEARFOTT: .We nave time. I just want to start 8 .out by saying I am not a toxicologist, I am not an 9 epidemiologist, I am not a biologist,'I am not in risk l 10 analysis, but I' feel like a voyeur about to become a target 11 in an interdisciplinary scientific spitting match. I 12 shouldn't have said that publicly, but I-am prepared to get
.13 wet, so tr'f comments are only from someone in a l
14 closely-allied area looking at what I have heard in the last
\, 15 day.
16 I view there as being three problems associated i 17 with this whole issue, credibility, certainty and 18 creativity. Credibility, we have a two-pronged problem. The l 19 first part of that problem is acceptance by the public. The
.20 second part is acceptance by the scientific community.
l 21 Certainty, we need to know what is really possible to answer 22 and how well can we answer it. We need to be realistic 23 about what we can know, what is needed to change things, and 24 the need to proceed in the public interest needs to inform 25 our interpretation of certainty, i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I I' i b
p 375 1- The third. issue, creativity, I am struck by a lack f /~N t t 3 2 .of new approaches. The approaches appear to be the same old
%./
3 types of research, although I was given some hope with the
- 4. humane genome project. There seems to also be some q 5 dissonance among the results that is based upon disciplinary
^6 lines.
7 I_would like to see somebody, and it is probably l 8 not NRC, but someone with timeframes for action, to try to 1 9: .look at radical advances, the Manhattan Project, broad and 10 forward thinking individuals who would be unrestrained and 11 ~ ; unfettered in looking at what are the fields and , 12 technologies, et cetera, and DOE has started to do that, l 13 that can inform this better. That is probably beyond what l 14 this particular committee can do. 15 I want to make some brief comments about what I l 16 viewed as each of the research areas and then make some 17 recommendations to you about that. First, is the 18 epidemiology, and I am going to also lump in there, and I 19 will get wet doing this, both the human, animal 20 epidemiology, and the non-human animal research, which I 21 tealize is much more controlled. It seems that that is 22 where the human endpoints reside. 23 The results of epidemiologists' studies will also 24 help us with workers in accidents, but may not be that 25- helpful because of the dose ranges that are practical in
'[ _
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376 l 1 l looking at public stuff, these two types of research are ' f\ b 2 very useful for testing low dose models. The work on this 3 data will help us, give us a better launch point or 4- extrapolation point, the lowest point at which we have data 5 about endpoints, and it will help us understand the 6 confounding fadtors that may be involved in the inductions 7 of cancer and other effects. We might need new studies E along these lines, but we have to be very careful about what 9 type of studies are done. 10 I also get the sense, and I will address this with 11 one of my recommendations, is that there is not really a 12 reanalysis of older data and good quality control of 13 datasets when trying to combine them to make a result. 14 The cellular biological research is the second ( 3)
, 15 category of research. I think these are important in giving 16 us the models to go below where the animal and non-human --
17 the human and non-human animal research takes us. It will 18 help us understand the possibility, the validity, et cetera, 19 of hormesis and is the basis of all our models. 20 We have to be very careful with the cellular 21 research, though, that we don't confuse damage and 22 significant response. 23 I think with these areas of the human 24 epidemiology, the nonhuman animal research and cellular 25 there are other issues that affect those that are holding ['
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ff 1 i I 377 1 them back, for example, the way that we're analyzing things. () 2_ 3 Secondly, different things like what dose quantity is being used and is it appropriate for the type of study. And I l l 4 have some basic questions about that. l 5 I also hear things like-well, the absolute doses 6 measured wil] .not really affect the-results, they just shift i 7 the curve. Well, if you have a nonlinear curve, having an l 8 error in your jumping-off point will have a very serioue 9- -effect on the results. For example, if you had an 10 exponential model, then where you're setting the doses and i 11 what quantities you're using for doses are going to 12 completely confound things. l '13 The third broad area is about regulatory research, l 14 how do you regulate and perform operations in the presence () 15 of uncertainty? I think the risk-informed approach is l 16- something that there's probably research, it's not 17 ccientific, but policy-related research on regulatory 18 -machanisms. That might be something that NRC staff should l 19 -be encouraged to absolutely continue. l l 20 The fourth area would be in risk communication and 21 how we do things, and in fact it informs how we treat the 21 results of the other research, and that's both to the ! l ?3 <I scientific community and to the nonscientific community. l 24 How do we get acceptance, how do we put through a change and 25- get that accepted? And how do we get scientific consensus l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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c: 378 1 among fields? Certainly risk communication and how to run t. 2 meetings and making sure there's open and how we do this is L 3 beyond my expertise, but I identify that as an area of 4 research. 5 The-last area is something that struck me in all 6 of this,. and this has to do with the synthetic methods of 7 analysis by which we integrate data from different 8 disciplines in order to get a result. And I'm going to 9 speak to that a lot. I do not believe that we have 10 necessarily institutional bias by NCRP, NAS, or NRC. There 11 is something more subtle going on that's affecting the 12 acceptance of this work, and I will address that. Areas of 13 this sort of synthetic methods analysis include items like 1 14 interdisciplinary peer review of what's happening and are '() 15 16 there -- what are the limits of science itself and to how we're reviewing things. Secondly, how you link disciplines 17 together to inform policy. And the third thing which we 18 actually were hearing a lot of this veiled today, the third 19 thing is how to analyze and build models with data from 20 different_ disciplines. So that's probably the area that 21 should receive the greatest effort at this point if you want 22 to do a fast result. l 23 I have ;everal recommendations that fall out of 24 that perspective. Some are -- they're on different levels. 25 Some appear trivial and some appear sort of more broad I i (' ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Cc
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I 379 1 sweeping. l 2 First of all, before hearing Otto's comments, I 3 was struck that not'only were a lot of the data that were 4 flashed before us very quickly -- not only were the dose l 5- ranges not going anywhere close to what we're interested in, l 6 subcentigray, and -- or wherever you want to pick it -- that 7 they were'not the right type of data. These are all 8 external exposures, except for the radon base, and I'll 9- privately discuss my opinions on that with anyone who will 10 give me ten minutes. They are primarily external exposures. 11 They exclude for the most part-not only sort of protracted 12- or low-dose-rate things, so we have no low dose, we have 13 very little low dose rate protr'cted exposure information, 14 but we're also missing high LET data. And those are exactly 15 the effects and things of concern when we're talking about 16 decommissioning, decontamination, low levels in the 17 environment. We're talking about internally deposited 18 radionuclides. 19 When you open that, there are things that aren't 20 even being looked at, like dose distributions within organs. i 21 I've done a bit of work in nuclear medicine, internal. , 22 dosimetry, and they found out that if you take an organ and j 23 you divide it into the different cell types, in vivo, that i 24- you assign dose quantities that relate to those cell types, 25 and-you use dose distributions on that to recalculate i b] ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut A/enue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L ,,
I l l 380 l l 1 things, you get a much better correlation between dose and l ' c'~) 2 effect. And I think they're just starting to do that in (
- s ms /
l 3 nuclear medicine and radionuclide-based radiotherapies, 4 which are right out at the front of the map in those two
)
5 disciplines. So there's a lack of internal data, which are 6 the most important, and if anything, you would serve the 7 scientific enterprise by supporting strongly, even though 8 NRC may not do or fund this, but supporting strongly 9 research in that area. 10 Secondly, we need to continue the biological 11 recearch support, DOE's program, and allow high-risk 12 Inncvative research. Along that line, because of the policy 13 implications of that research, it is imperative that NRC be 14 engaged, even as an observer, in the interagency reviews of () 15 research in these areas. j l 16 The policy issues, as we heard, are quiet strong. l i 17 The industrial issues, as we heard from President Quinn of 18 ANS, are quite strong. So in research being conducted and 19 things going on with NAS, DOE, NASA, DOD, NCI, et cetera, in 20 particular the new DOE program, NRC should at the very least 21 have active observers following what's going on so that NRC 22 can stay in touch with changes, advances, while they pursue 23 concurrently what they need to do in terms of other issues. l l 24 I'm just going to put in a plug for this, as we l 25 cannot ignore the need for research aimed at cost reduction ('N ANN RILEY & ASSOCIATES, LTD.
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r-p 381 l 1 in measurements and remediation activities despite trying to t () 2
-3
.look at our limit, I think cost reduction is something that will actually help the industry.
4 My last point ir probably the most controversial, 5 and it sort of has two parts. I don't believe in a 6 conspiracy theory,.but in hearing how BEIR and NCRP are 7 working, and we've heard'their consensus process, I think 8 these are very noble efforts to do a proper consensus I 9 process, but you uhink about it, you have 16 experts on a 10 BEIR report, and there will be one person who actually is 11- the person who is figuring out how to tie together all the 12 data and derive the result. This might be a' mathen atician 13 or statistician or someone. The same thing with NCRP. 14 You have 60 council members. There are not very . /~N l( ) 15 many of these data-synthesizing people involved who are 16 council members of the NCRP. When the BEIR and NCRP reports
~
i 17 go out to comment, they go out to the stakeholders. They go l 18 - out to the. specialists in radiation protection, they go out 19 to the radiation biology specialists who may' favor, just by i 20 virtue of being scientists, they're going t'o favor _ theories 21- that support their own work. And it 's not going to cg) out l 22- to mathematicians, the statistical society, to the people 23 who are scattered across disciplines who are actually 24 -bringing together the work. So-I would favor something that
- t. 25 said there needed to be independent research in the O ANN RILEY & ASSOCIATES, LTD.
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p 382
- 1 synthesis of this data and analysis by which these models
) 2 .get derived. 3 And I would further wildly speculate that there 4 have only been a handful of individuals involved 5 historically with that in the past. Which I then sort of as 6 a slightly more wild recommendation would say the following 7 which actually Fupports (e), which is that we need to have 8 because of the historical mistrust by both the public and 9 the scientists, and this is a large undertaking I recognize, 10 some independent new group or groups that will start doing 11 two things. ) i 12 I . n.-:an , one thing, you could totally revise the 13 NAS and the NCRP process. That's one approach. The other 14 is to try to' find a new group or groups that will do two j 7-s 1 ( 15 things. No. 1, they will rereview and attempt to synthesize 16 the existing data, making sure there's peer review of the 17 experts who are doing-the synthesis. These.are people from 18 math, statistics, et cetera, who happen to have specialized 19 in radiation. But they're not getting peer review 20 necessarily by people outside the radiation field in the 21 synthesis. 22 And, secondly, there might be something to be 23 gained by taking all the data that we have, doing quality 24 assurance or quality control in reanalyzing it. When you do 25 that, you have to be very careful you don't miss 75 percent l ANN RILEY & ASSOCIATES, LTD. O' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I_- f 383 1 of the data, and, secondly, that there's an independent 2 judgment, interdisciplinary independent judgment of the ' [G~'i 3 quality of the research. No matter how nice'your data bases t
- l. '4 are, if you don't do'that, you're not going to get results t
5 that are-totally credible. 6 So I think I've said more than I should have, and. 1 i 1 7 th'at summarizes my impression of this meeting. l I l ~8 DR. GARRICK: Thank you. l l 9 Otto? 10 DR. RAABE: Okay, back to me. I 11 'Well, I don't have quite as elaborate a
'12 presentation prepared, but I made the point about protracted 13 radiation, which is something that's very near to what I'm 14 thinking about, and I wanted to just point out a few things
() 15 that we do know really well about protracted irradiation. 16
~
l For example, a lot of people in this century have 17 been exposed to radium-226, and this has been under study L 18 for a long time. This book " Radium and Humans" written by-l 19 Bob Rowland out of Argonne Laboratory summarizes all the 20 data, the effects data and the dosimetry data, on some 2,000 l 21- people, 1,450 of them who were exposed to radium-226, very 22' high levels, mostly earlier in the century. Radium was -- I 23 think Marie Curie got the Nobel Prize for separating radium L 24 in 1905 from uranium, and after that it was used for all 25 kinds of things, medical potions, put in drinking water, and O ANN RILEY & ASSOCIATES, LTD. Court Reporters-1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 \
F 384 1 for luminous dials. And by 1909, just four years after she l t ()
\,)
2 got the Nobel Prize, you could buy a watch with a luminous 3 dial or a clock with a luminous dial with radium. And the 4 workers who worked with that material got exposed at high 5 levels. But also chemists got exposed, and it was used in 6 medicine. 7 Well, the studies of these people have gone on for 8 at least 50 years. Robley Evans was a big investigator in 9 this at MIT, and then it was taken over by Argonne. ; 10 What do these data tell us about high LET 11 irradiation of the skeleton from radium? That's the 12 question that we have human data. Well, Robley Evans in 13 1972 went around the country and pointed out in lectures he 14 was giving, he was president-elect of the Health Physics A (J) 15 Society at the time, he went around and said hey, there's a 16 practical t.hreshold. The reason I know this is because no 17 person whose dose to the skeleton was less than 1,000 rad, 18 which is 20,000 rem after you correct for the quality factor 19 for alpha particle, developed bone cancer or had any other 20 effects that we could observe. That was 1972. 21 Okay. Now we have Rowland's report just a few 22 years ago summarizing the final data -- that it will get. 23 There were a lot of people rtill alive in their eighties and 24 nineties in good health that dic a' t get into the final 25 report when the study ended. [^T (,) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
e L 385 l' What is Rowland's conclusion? No person whose t [} 2 dose to the skeleton'was less than 10 gray, 200 sievert, 3 20,000 rem, developed bone cancer. We're talking about a 4~ gigantic dose. Is this a fluke, or is this real? Okay. So 5 you look at animal studies with radium. Well, it's easy to 6 show-why.this occurs with protracted exposure. It occurs 7 ~ because when' exposure is protraced over a lifetime, there
'8 isn't a linear response, nothing happens for most of the i
9 ' person's lifetime, and there's a long induction period until 10 you actually have the bone cancers develop. 11 As the dose rate.goes down, which is the 12 concentration of radium in the skeleton, and you have to 13 remember that when people were exposed to radium they had it
.14 in their skeleton for their lifetimes, yes, it was' cleared
( 15 over time, and it was reduced, and it went down as a power 16 function with time. So that when they were very old, they
-17 had very little left. .But they got irradiated almost over 18 their whole lifetime after initial exposure. And so this 19 means.that when you look at the data from the human studies l
20 and the animal studies, they turn out to agree. And I 21 published this in 1980 in " Science." 1 22 They agree very well, and.also the mouse studies. 23 What--they show is that as the average concentration of 12 4 radium in=_the skeleton gets smaller, called the dose rate, i 25 if'you-will, the time required to develop cancer gets longer i f ANN RILEY & ASSOCIATES, LTD. O- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
= 386 1 and longer and longer. Now it turns out it takes less total () 2
'3 dose to produce the cancer at low dose rates.
always confuses people. This is what They say well, you know, lower dose n 4 rates are more dangerous. They look at this. You heard l 5 this yesterday. It's absolutely true. It takes one-tenth ' 6 as much total dose to reach a point where there's cancer in 7- people and the dose rate is lower. But the time keeps 8 getting longer and longer. 9 Eventually a finite population of people die of 10 age related illnesses. They die of old age or something 11 else. l 12 When the time required to produce the cancer 13 exceeds the lifespan, you cet no cancers. We are talking 14 about competing risks. ;
) 15 Now if medical science were to extend the life 16 expectancy of people we would probably have to lower some of 17 our radiation standards, because what we are talking about j 18 to my way of thinking for these protracted exposures is that 19 in our normal lifespan we don't live long enough for some of 20 these low doses to have any effect, and that is exactly what 21 we see in these people and it is exactly what we see in the 22 animal studies.
l 23 They agree exactly and also the distribution of , 24 the cases of bone cancer from radium is not a broad 25 d4"tribution. It is very narrow. ANN RILEY & ASSOCIATES, LTD.
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I' i l 387 l 1 In fact, in the biological system a coefficient of
) 2 variation'of onlyl20 percent is kind of a minor miracle, and 3 that is what it is for the anima 3 studies. It is about 30 l
4 percent for the people. When you plot this up, the average 5' radium in the skeleton versus the time to development of 6 . cancer the coefficient of variation is only about 20 to 30 7 percent. It is really tight, and all it shows is that ae 8 dose. rate goes'down people have to wait longer to get the j 9 cancer,Leven though the radiation is more effective on-a j l 10 total ~ dose basis, but you end up with this lifespan 11' effective threshold. 12~ But it is real so you look at these people below 13 110 gray, 200 sieverts, 20,000 rem, over their lifespan --
~14 they don't develop bone cancer, they don't have any other
() 15 effects that we can see, and the same is true in the beagle 16 studies and the same is true with plutonium and the same is ( 17 true with. Strontium-90 is a low LET radiation. We studied l 18 that at my laboratory and -- non-linear. It is a threshold
- 19. type response again.
j .20 When I say it is a threshold type response, I 21 don't mean that there's some dose here below which the risk 22 is zero. I' don't mean that at all. 23 Okay, so what we are dealing with then is perhaps ; 24 this range. Now when I started in this field in the '50s I i 25 'and I went to graduate school at the University of
~ l i
[~' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i Washington,-D.C. 20036
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388 1 Rochester, they said oh, we are going to use this linear
!m ) 2 model for radiation protection. Now we know that it is NI 1
3 probably wrong but it probably overestimates the risk, so if 4 we are just going to worry about radiation protection and we 5 want to set up some standards, we'll use this linear model. 6 I think the problem came in the '70s when the ICRP 7 started writing things into some of the reports that 8 suggested that they believed they could really count bodies 9 with these models, so you use this linear model. 10 Now what if we had a standard of 100 millirem per 11 year for the public and people actually got exposed to an 12 extra 100 millirem per year for their whole lifespan -- 70 1 13 years? 9 14 The linear model would predict an increase in (,< y) 15 lifetime cancer of about .3 percent -- .3 percent. On the 16 other hand, if you look at this type of result from these 17 data with several radionuclides, every one I have looked'at 18 comes out this way. It is not a fluke. It doesn't make a W 19 difference which laboratory or which radionuclide. They all , 20 turn out this way. ' 21 If this is more representative of those protracted i 22 exposures, then the risk is considerably less than .3 23 percent, so the uncertainty we have is somewhere in that 24 range. It is probably lower than .3 percent. It could be 25 so small that it's almost meaningless -- certainly not ('] (ms ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L
389 1 measurable. K-2 Nowifrom the point of view of the statistician 3' such as Charles Land,~whom we heard yesterday, if you just
-4 go out -- even when Charlie talked -- Meinhold -- if you 5 just go.out and say, you know, you can't find that, you're 6- right. You cannot just de novo go out there and try to find 7 a .3 percent increase in cancer rates in the general l
8 population where 30 percent of people are developing cancer. 9 You just can't find it, so there is no statistical test and 10 no study you are going to do that makes any sense that will 11 ever find that if it is .3 or to be able to provide that it
- j. 12 is not .3 but .1 or .01 or .001 or 10 to the minus 20, 13 There is no way that you can do that directly.
14' So what we are stuck with then is that we have got 15 to look at what we do know, which is mostly high doses and 16 see if we'can figure out what the processes are involved. 17 Now why does this occur? Well, to my knowledge 18 nobody has figured out how to_ tie together the acute ) 19 ' exposures which are much more effective at causing cancer j 20 with the protracted exposures, because we know that at one 21 sievert we can increase in an obvious way the cancer rate in
^22: _ people from the atomic: bomb survivor data.
I 23- These studies with Strontium-90;or radium, we ' 24 _cannot see anything at 1000 rem if it was spread out over l~ 25. the whole lifetime, but we know if we give them ANN R1 LEY & ASSOCIATES, LTD. ! O- Court Reporters 1025 Connecticut Avenue, NN, Suite 1014 Washington, D.C._20036. (202) 842-0034 l
p (. 390 1 instantaneous exposure to 100 rem there will be a 60 percent (~ 2 increase in all kinds of cancers so there is a big A)) 3 difference, and one of the problems is the model that is -- l 4 the paradigm model that is in the minds of-the people we l 5 heard who are promoting the basic linear model.
- 6 The paradigm is oh, well, you know, the i
l 7 protraction lowers the slope. You just need a correction 8 factor. It is still linear but we are going to lower the 9 slope -- but it doesn't look like it is linear anymore. 10 So in other words, we don't understand the
- 11 mechanism that gets us from radiation exposure to cancer.
12 If we can't explain these data as well as the atomic bomb l 13 survivo'r data. If we understood the mechanism we could 14 explain both sets of data -- so there is a big hole in our () 15 ~ understanding. 16 As long as there is that hole in our understanding 17 there will be disMgreement among scientists on this issue. 18 I am not sure how we can get away from that. 19 DR. GARRICK: Yes. Reaction to the pub 1' u they 20 took that out of context could be very negative 21 DR. RAABE: Of course. 22 DR. GARRICK: That we don't understand the 23 relationship between radiation exposure and cancer -- 24 DR. RAABE: We don't know the exact mechanism. 25 DR, GARRICK: Yes. l ANN RILEY & ASSOCIATES, LTD. f Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i l l J
h 391 1 DR. RAABE: We know that you get -- you expose at
~( 2 certain levels, you get some increases in cancer.
)
3 DR. GARRICK: But it seems that the concept of 4 looking at the issue not in terms of a threshold but in l ! 5 terms of a curve, if you wish, that can give us insight on l 6 what the likelihood is of getting cancer is a much more i 7 ' logical representation of the science than the debate about I 8 a threshold. 9 DR. RAABE: I agree with you. I agree with you. 10 Yes, absolutely. It is curvolinecr, you know, and I mean l 11 it's_ easy to sh0w that with human data -- now of course the l 12 human data that throws a spanner in the works, as the 13 British would say, is the radon stuff that we heard, because 14 they fit this log linear model which they call a linear !( 15 model and the people who did that really believe that it is 16 a true model so you have this case where you have protracted 17 exposure. 18 Now personally I believe that there is an 19 effective threshold for the radon stuff too but it hasn't i 20 :aeen well demonstrated, and-you have these data which are 21- very hard to interpret because of the uncertainties in dose 22 and other factors. 23 DR. GARRICK: It also seems that a lot of progress 24 could be made if we think more in terms of radionuclide 25 specifics about thresholds --
/~Y ANN RILEY & ASSOCIATES, LTD.
k) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 2003G (202) 842-0034 I i 4
g ,
;n-1 DR. RAABE: Absolutely. Absolutely.
() 2 DR. GARRICK: Than mixes, and this is kind of 3 appealing, because in the nuclear waste disposal issue we 4 _usually end up talking about a very few, very few 5 radionuclides, and in fact you can almost generalize it. 6 You can almost say that for low-level waste Lecause more of 7 it's uranium contaminated than we ever anticipated that the 8 driver for long-term exposure will be uranium. l 9 For transuranium waste we have seen that the 10 driver over the compliance period of the repository is i 11 principally plutonium. And for the Yucca Mountain waste, we i 12 now know that for periods beyond 10,000s of years that the 13 driver is going to be things like neptunium-237, with the j 14 early dominance provided by iodine and technetium. () 15 So the truth is maybe we're just not taking 16 advantage of the characteristics of the problems that we're 17 having to deal with with respect to getting the most mileage 18 out of what we do know. 19 DR. RAABE: Yes. And there are some holes in what 20 we know about'those things, too. Plutonium, for example, 21 I've done a lot of work with plutonium in my career, and 22 I've measured plutonium at the Nevada Test Site in the 23 fifties, and I've done modeling, and I've made particles of 24 plutonium, and I've gone to fuel fabrication plants and 25 studied the plutonium particles that were produced during 0' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025-Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 (202) 842-0034 l
p 393 i 1 fabrication processes, studied the solubility of plutonium l [) 2 in different forms, and have worked with and was involved in i \) m 3 experiments where we exposed beagles to plutonium particles 4 that we made specifically to find out about effects on the l 5 lung. l 6 And I've modeled the results of these studies. 7 Unfortunately the studies, they were all funded by the 8 Department of Energy, and at the time when the last beagles 9 were dying, they took away the money, so the final complete l 10 analysis -- they got more interested in genome work at that i 11 time. So the money got, you know, shifted, because they 12 thought the genome work had a bigger payoff. 13 So the analysis was never totally completely done, 14 and data are still available for that, but I have done these I (_,/ 15 analyses of plutonium, and again you find this threshold 16 phenomenon, for t.he same reason. So I then estimated by a 17 scaling process that I developed what the human risk would 18 be from inhaling plutonium. 19 So then I said well now I find some human data to 20 try to see if it fits the lung risk from inhaling plutonium. 21 There isn't any. Not in the United States. Because 22 although thousands of people have been exposed to plutonium 23 by inhalation in the nuclear industry in the United States, 24 we've got no documented cases of the lung cancer being 25 produced by anyone exposed below the standards -- or above I~\ ANN R7. LEY & ASSOCIATES, LTD. ks m Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I l 394 1 the standards -- in the United States. f) v 2 Now they tell me the Russians are going to supply l 3 the data, and they actually have been, because they weren't 4 being as careful as we were. And so they had people exposed 5 to very high levels. But those data are very complicated, ( 6 because they didn't get exposed to just plutonium, they got 7 exposed to neutrons and external radiation, gamma rays, and 8 all kinds of things. 9 But they have two papers been published out of 10 Russia on this, and one was published in the Health Physics 11 Journal in December, and it shows that -- it states in this 12 paper that there were no effects -- well, I should point out 13 before I get to that that I estimated that the effective 14 threshold, the place where the risk would drop quite
/~s
( ) 15 precipitously, was at about one gray to the lung, which is 16 about 2,000 rem. So -- because with the alpha particles 17 from plutonium, but one gray. 18 Well, the paper that was published in the Health 19 Physics Journal from the Russian data. They found that 20 below eight-tenths of a gray they had no effects that they 21 could identify, no lung cancer. 22 But to confuse the issue, another group at the 23 same institute published a paper in Radiation Research where 24 they fit a linear model to it. 25 DR. GARRICK: Yes. I l l [~'} (_ / ANN RILEY & ASSOCIATES, LTD. Court Reporters i f 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 ) (202) 842-0034 '
r 395 1 DR. RAABE: The same data. Fit a linear model to l (T 2 it and claimed that you could describe it with a linear lV 3 dose-response model. 4 Well, that's not new in our industry. The 5 reason that it works so well is that when you actually plot 6 up the data -- I've done this many times -- when you 7 actually plot up the data as a function of cumulative dose 8 and look at the shape, what I call the threshold region or 9 the region where the risk gets very low is very tiny, it's 10 right at the origin. It's smack up against it, because 11 all -- it's down there below cne gray, and all the effects 12 are 2, 3, 4, 5 -- and so it gets shoved over in the corner, 13 and you've seen that on some of these plots yesterday. 14 DR. GARRICK: Yes. n f j 15 DR. RAABE: And it's just a little squiggle, ; 16 because it's not caused by the radiation, it's caused by the 17 life-span limitation. See, it's not -- the radiation is 18 causing this straight line to appear that maybe it's a 19 straight line, I don't know in this kind of plot, it looks 20 curvilinear to me, but you can put a straight line through 21 it. The radiation's causing that straight line. But that 22 little squiggle, which is the life-span limitation, is 23 caused by'something else. People are dying of old age. 24 Well, you can draw a straight line through it and 25 it looks great. In fact, the year that Evans came around
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r 396 1 the country and promoted this model, Chuck Mayes and Ray (\ 2 Lloyd took the very same data and they regrouped it, plotted V 3 it on a linear scale, and drew a straight line and declared 4 l there's a linear dose-response. Same data. 5 DR. GARRICK: It's amazing what you can do with 6 the least squares fit. You can make almost anything. 7 DR. RAABE: And it does look good. It looks very 8 good. You look at it and say hey,. yes, that's a straight 9 line. Well, that threshold there, this is a log plot, that 10 threshold is way down here in this little squiggle at the 11 bottom, but it's a very important squiggle if you're only 12 exposing people to a few millirem per year -- or a few 13 hundred millirem per year. l 14 DR. KEARFOTT: I just have a question for Otto. l [ JS It seems to me another source of data, there are the animal
.,s_ ; :
16 data, but another new source of data, a long-term thing, are 17 the Chernobyl data. It sounds though like what you're 18 saying is you're not going to see an effect there anyway. 19 DR. RAABE: Well, as you know, they have been 20 studying, looking for effects from Chernobyl, and the last l 21 reports I heard, which were I think a year ago when I was in 22 Vienna, basically said that they haven't found leukemia that , 23 was predicted by the linear model from the atomic bomb l 24 survivor data, they didn't have any of that leukemia; what 25 they did find was thyroid problems with children. That r ANN RILEY & ASSOCIATES, LTD. (],/ Court Reporters 1025 Connecticut Avenue, NW. Suite 1014 l Washington, D.C. 20036 (202) 842-0034
f 397 1 conflicts with some other data that's around, but, you know, l /) 2 still it doesn't sound unreasonable that high doses of I131
\~ 1 3 to children could increase their cancer rates, and it's not 4 unreasonable, but I've heard people say that that data is a 5 little bit hard to interpret too because they don't have any 6 good baseline information about the number of nodules in the 7 thyroid and so forth, and suddenly they come in with this 8 team of people looking at all the children, and so forth.
9 But I think that's believable, that the I131 10 exposures to children did produce this effect. They were 11 high doses, very high doses. But nothing else has come out 12 of it, and certainly leukemia did -- they expected it would 13 appear within ten years, you know, they didn't find it. 14 DR. GARRICK: I wanted to ask a question. We've () m f 15 discussed this several times, and I'm becoming convinced l 16 more and more of the problems with it, but one thing that 17 I've never really felt that I could completely resolve in my 18 mind was we have at all our nuclear installations since the 19 late forties been wearing film badges and dosimeters and j 20 monitoring ourselves quite carefully and health physics and 21 radiation protection in the various reactors and also the 22 laboratories have been tenacious in seeing to it that we do 23 that, and also. supplementing our own measurements with their 24 own measurements in areas where special kinds of work were 25 being conducted. And yet I get the sense that this enormous i l (~) ANN RILEY & ASSOCIATES, LTD. i (_) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
r-i l 398 l 1 data base is relatively useless. 1 [~')
\/
2 What seems to be terribly disappointing because I 3 it's low dose, most of it, and it's very population l 4 oriented, but I guess it's a combination of confounding 5 factors and issues having to do with identifying the 6 individuals and how they died and what have you. Why is ! 7 that tremendous data base not more valuable in addressing i 8 this issue? 9 DR. RAABE: Well, the workers in the United States 10 have been under study at various laboratories, and the 11 Cardis study that was discussed -- 12 DR. GARRICK: Yec. 13 DR. RAABE: Is a very comprehensive, complete 14 study, and, you know, whs.t it showed, we heard some comments
/
(3) 15 this morning about it, what it shows is that when you really 16 look at the workers, you can't disprove the hypothesis that 17 there's no risk, and yc,u can't disprove the hypothesis that 18 the linear no-threshold model is correct, because the 19 uncertainty, even when they have thousands, tens of 20 thousands of workers in this composite study, the 21 uncertainty is great. And you saw the data presented 22 yesterday. There is a couple leukemia cases -- there are 23 two labs that have high leukemia and the others did not. In 24 fact, at Oak Ridge leukemia is lower in the exposed people 25 than -- l l /~ ANN RILEY & ASSOCIATES, LTD. l \s-)/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I l 399 1 DR. GARRICK: Well, we may not be able to -- l [
\
2 DR. RAABE: You know, so it's -- i 3 DR. GARRICK: Yes, but -- 4 DR. RAABE: You can't reach conclusions -- 5 DR. GARRICK: Okay. But you did this, you broke 6 the problem down into a linear problem and a threshold 7 problem. Maybe you can't address the issue of linearity, 1 { 8 but can't you say something on the basis of this data base l 9 about threshold? I mean, the fact that we can't do 10 anything -- I 11 DR. RAABE: No. No. 12 DR. GARRICK: Suggests to me that there's -- 13 DR. RAABE: What this largest study of these data, 14 the Cardis study, has shown, international study, is that r (m) 15 you can't say anything about the threshold. You can't 16 disprove the hypothesis that the dose response is linear, 17 and you can't disprove the hypothesis that there was no 18 effect at low dose. You can't disprove either hypothesis. 19 DR. HORNBERGER: Well, it depends on what your 20 null model is. 21 DR. RAABE: Beg your pardon? 22 DR. HORNBERGER: It depends on what your null 23 model is. He is saying if your null model is no effect, 24 then there is a threshold. 25 DR. RAABE: Well, I'm saying that the uncertainty, I l ANN RILEY & ASSOCIATES, LTD. O(_) Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
r l l l l 400 j l 1 I mean, you have to compare it to something. So they l l (N
\ ,)
2 compare it to people at high dose or low dose. I l 3 DR. GARRICK: Well, there's an uncertainty because 4 you didn't observe anything. I mean, you didn't see -- 1 5 DR. RAABE: There's not much happening. That's ! 6 right. 7 DR. GARRICK: But to me that's -- l l 8 DR. RAABE: As Keith was saying yesterday, we ! 9 don't know the risk. 10 DR. GARRICK: What am I missing here? To me 11 that's extremely valuable information. 1 12 DR. RAABE: It is, but it doesn't -- you can't 13 reject the LNT on that basis, and so you'll always have l 14 somebody -- .I () 15 DR. GARRICK: No, but again if I look at it in its 16 component parts, and in this case look at threshold, rather 17 than linearity -- 18 DR. RAABE: We have a fantastic record of 19 radiation safety in this country. It's too bad that we 20 can't tell the public about it, i I 21 DR. GARRICK: Go ahead. 22 DR. KEARFOTT: This goes back to what I was 23 attempting to articulate and which I think Keith Dinger l 24 yesterday was trying to do but were not the right l l 25 specialist. Isn't there something in risk where you have a i l (}
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401 1- study like this that you can say that the study shows that
~'\ 2 within uncertainty sigma that the risk must be less than x
[Y ' 3 under a certain dose. Isn't there a way you can make a l l 4 statement like that? l 5' DR. GARRICK: Sure. 6 DR. KEARFOTT: And'isn't that what should be 7 coming out of this? And why aren't we getting this? 8 DR. GARRICK: That's my perspective. That's -- 9 DR. HORNBERGER: But again, as Land said, what 10 you're going to be able to say with that kind of study is an 11 upper bound, and the up,per bound you can't discard the LNT. 12 DR. GARRICK: Exactly right. 13 DR. KEARFOTT: Which is fine. That's fine. Who 14 cares? () 15 DR. RAABE: That's why I started off. I said 100 16' millirem per year, you can calculate from the ICRP model, 17' 'three-tenths percent increase in cancer over the lifetime if 18 someone's exposed to 100 millirem every year for 70 years. 19 It's probably not that high. It may be effectively zero. 20 We don't know, and we can't prove it.
-21 DR. HORNBERGER: Right. But, see, my point is 22' that, you know, statistically, if you start with your null l
' 23 model being that the-slope is zero, the data can't refute
'24 that.
25 DR. RAABE: That's right. ANN RILEY & ASSOCIATES, LTD.
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c 402 1 DR. HORNBERGER: I mean, that's just an alternate 2 way to look at it.
)
3 DR. RAABE: TFe data cannot re.*ute that. That's
.4 right. You cannot disprove that hypothesis, that it's zero.
5 Now, we're not talking at all about -- I'm not 6- talking at all about any beneficial effects. I mean, if 7 there - we heard about beneficial effects, and if there are 8 beneficial effects that affect carcinogenesis, that will 9 alter the findings. 10 DR. HORNBERGER: Yes, but most of the worker 11 studies show the healthy-worker effect. Certainly the Oak 12 Ridge study showed it. 13 DR. RAABE: I think'they all do. 14 DR. HORNBERGER: They all do. () 15 DR. RAABE: A.1d yesterday we heard that the atomic 16 bomb survivors showed it. 17 DR. HORNBERGER: Right. 18 DR. RAABE: The healthy survivor effect. 19 I've never gotten an answer to this question, 20 because I heard this rumor, and I presented it as a rumor to 21 Charles Land yesterday, and I don't think he bit on it. 22 DR. GARRICK: I see. the jokes now. The bad news 23 is you're going to be bombed tomorrow by an atomic bomb; the 24 good news is if you survive, you'll be healthier. 1 25 DR. RAABE: Well, -- ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 14 (202) 842-0034
f 1 i i 403 1 ( DR. HORNBERGER: You didn't say that, did you? (~N) QJ 2 That's going to look terrible in the official transcript. l 3 DR. RAABE: The Japanese kept very, very good l 4 records of where people lived, and when they were born, and I i l 5 when they died, they kept extremely good records. And I ! 6 heard a rumor that there was a control group that consisted l i 7 of people who did not -- were no: present in Japan, or in 8 Nagasaki and Hiroshima at the time of the bombing, and they 9 decided not to use it, the rumor, because the people -- most 10 of the people who were exposed had much lower mortality and 11 lower cancer rates. 12 Now, I have never been able to prove that to 13 myself. I have never found that. And that is why I asked 14 Dr. Land, and he didn't say anything against it. He did say q j 15 there was 26,000 people that were taken out of the study 16 because they didn't like the way they looked. You know, as 17 a scientist, I worry about these things. I don't like 18 censoring the data because you don't like the way it looks. 19 DR. GARRICK: One of the things I -- oh, excuse 20 me. Go ahead. 21 DR. KEARFOTT: Oh, no, it's off. It's a slightly 22 different topic. 23 DR. GARRICK: One of the things that, and this is 24 maybe a slightly different topic, too, but you reminded me 25 of it, that I wanted to raise yesterday, is that I recall, (^h ANN RILEY & ASSOCIATES, LTD. (s,,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
404 1 in the last two or three meetings we have had on this issue, () 2 that one of the arguments given against some of this data p3 that we are hearing hasn't been adequately considered, 3 one 4 of the arguments given is that part of the problem is that 5 it was not done under controlled experiment conditions, or 6 that it was not supported with a quality assurance standard 7 of some sort. 8 Is there a way to take old work and put a quality 9 template on it of some sort and move it out of the zone of 10 not being useful because of that, and into the zone of being 11 accepted? 12 DR. RAABE: Every paper I read, I try to evaluate 13 the quality of it because there are so many things that can 14 happen. Experiments are very complicated. And I think in () 15 some cases, and I can't, you know, pick -- as I say, every 16 paper sort of has to be looked at separately. You have to 17 look at the study and figure out what the potential flaws 18 are. Sometimes there are big ones. And those flaws can 19 lead to great uncertainties, which makes you doubt whether 20 the results are meaningful. That is why repeated studies 21 that show the same thing are so important in science. { 22 You know, we know about cold fusion, fc . example, 23 you know. Whatever happened to cold fusion? Well, it 24 wasn't repeatable. And you could go through the original 25 paper and say, well, you know, it looks right. Okay. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
g I 405 1 So, this is the thing, there are all kinds of () 2 3 pitfalls that.even the best scientist can fall into these pitfalls, even trying to be careful. And so, yes, every ! .4 time you see a result, you have to say, well, what -- you 5 know, is.this correct, or are there other problems? And'you 6 try to evaluate that. In some cases you can see there are 7 problems. And, usually, the kind of problems you see, for 8 instance, animal studies is the author does not tell in any 9 detail knw they selected the controls. That is one of the 10 -big problems that occurs in so many studies. Controls are 11 so important. 12 In the case control study, you have to know 13 something about the controls if you want the confounder 14 situation to be stable. And, typically, you know, I have
) 15 just got to get on to this, there are lots of studies that 16 come out. Here is the Rocketdyne study, you probably heard l 17 about this, it made the news last year, out of UCLA, where
- 18 they -- lots of studies like this, small studies, where they 19 are looking at nuclear workers, and they are finding, in l
20 effect, and they are saying that radiation is much more L 21 -dangerous than we ever believed because they found a 22 statistically significant effect at a very low dose. The 23 . exposure of these people was very small, but there was a 24 statistically significant effect to higher exposed people 25 versus lower.
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l i 406 1 And we look at it and say, well, -- and there are () t 2 lots of these. There is'the Steve Wing paper, several of 3 them. What is going on here? How -- you know, because this 4 is going to happen. You are going to see this kind of l 5- alternative paper in the literature. I am sure this is 6 published in some statistical journal now. l 7 Well,.there'is a big problem with these epi 8 studies. The problem'is that the confounders are very 9 difficult to work with. The other kinds of exposures that 10 -occur are very difficult to. quantify, and when the study is 11 lione, the only good measurements that the researcher can 12 find about these workers is the radiation exposure, because i 13 it has been documented perfectly. You know, if you are 14 doing any kind of fitting of data which has multi-factorial () ~15 data, one of the principles of regression is the 16 measurements that are made with the greatest precision tend 17 to dominate the response, even though other factors are 18 actually causing the response. So you get the impression i 19 that the best measurements have a cause-effect relationship 20 when all they have is an association that is related to the 21 way which they are done. 22 But we have -- okay, what are the confounders? l
)
23 Well, cigarette smoking. In this case, I talked to the 1 24 author. He based his conclusion on four cancer cases in the l 25' high dose group. One was a Hodgkin's lymphoma, which is not fri - 70R7 RILEY & ASSOCIATES, LTD. hs/ - Court Reporters . 1025' Connecticut Avenue, NW, Suite 1014 I Washington, D.C. 20036 L (202) 842-0034 l-
( l 407 1 believed to be radiation sensitive anyway, one was leukemia,
) 2 and two were lung cancers.
["'/ N-And I said to the man, the two ! 3 that were lung cancers, were they cigarette smokers? And he l 4 said, I don't know. Well, what about cigarette smoking? 5 Well, we took some side groups and we tried to balance it 6 and it looked like about the same number of people were 7 smokers in the control group as the exposed. But he didn't i 8 -- but they didn't do it, it was a side study. They didn't { 1 9 l l actually do it in the main study, i l 10 So he was basing this -- you know, okay, well, the { l 11 principle of confounders is that if your control group has 12 the'same percentage of smokers, obviously, there is also ) 13 dosimetry there. How much do they smoke and so forth? But 14 if they have the same number, the biostatistician thinks he () 15 has got it cov3 red. But if there is only four cases, or two 16- cases that you are dealing with, forget it. The normal i 17 proximation doesn't work for two cases. 18- DR. HORNBERGER: If there are four cases in the 19 high group,.how many in the low group? 20 DR. RAABE- Oh, well, there are lots, I have the 21 numbers. l 22 DR. HORNBERGER: No, no , no. But four cases -- ; 23- DR. RAABE: A lot. Lots. But the low group is a i ! 24 big group of people and the high group is only 20, or 17 25 people.
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a 408 1 DR. HORNBERGER: Gotcha. Gotcha. L () -2 3 DR. RAABE: But this comes out, you know. had a big press conference. They Let's see, they -- I don't have 1 I-i 4 them.all here, but they had a big press conference over, you 5 know, 17 workers, two cases, in the high group. Three cases 6 in 210 workers, lower down, and six cases in 723, and then l-7 at the lowest group, three cases in 1,333. Well, that 8 becomes statistically significant -- two cases in 17 9 workers. 10 Well, you say, well, okay, well, leukemia is 11 involved there. Well, what about their exposure to organic 12 solvents? Well, we didn't measure that. There are no 13 objectives for that, we could.n't figure that out. Did they 14 smoke cigarettes? Well, I don't know, we don't know. Did
- () 15 those two cigarettes? We don't know. Didn't you look? No.
16 But this makes the news. 17 Steve Wing came out with a study that was the ' 18 classic in epidemiological fishing expeditions, where you 19 look through all of the data, you know, 40 different kinds 20 of cancer, and find one that seems to be increased with 21 dose. This was multiple myeloma that he found. Actually, 22 it wasn't increased with dose, which is kind of interesting. 23 'There's four labs. He took Battelle Northwest, Oak Ridge, I 24 think -- I am forgetting what the other two labs were, but 1 25' he had four DOE laboratories that'he was working with. And L ANN RILEY & ASSOCIATES, LTD.
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409 j 1 he look at this multiple myeloma. (~h 2 Battelle Northwest, in 1979, Ethel Gilbert L) 3 reported that there was an anomalously higher level of 4 multiple myeloma in workers at Battelle Northwest. This 5 didn't occur anyplace else. And you can have all kinds of l 6 random things happen with 40 dif ferent kinds of ' cancers in 7 your list. 8 Well, so, he had this as a starting point. And 9 when he did the case control study, he found no radiation 10 effect on multiple myeloma, but that didn't stop him. Then 11 he partitioned the people into the age at which they started I 12 working, only he grouped people lower than 40 years and i 13 higher than 40 years. Bang! His computer program gave him a l 14 significance. And he ended up making a videotape that was ! /~N
'( ) 15 shown to all the workers, you know, I am saying, you know, 16 you have got this higher risk of multiple myeloma.
17 You know, so, on the other side, I mean we have to 1 18 -- we have got one side here with people coming in and 19 saying, well, you know, radiation is really not that 20 dangerous and maybe even beneficial effects. Then you have 21 these other papers coming out from scientists who are 22 recognized in way or another saying, oh, it is even worse 23 than we thought. So that goes into the pot. 24 What does the public hear? Well, the public heard 25 this. They had a big press conference. It made all the
) ANN RILEY & ASSOCIATES, LTD.
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410 1 newspapers in California. The public heard about Steve [) 2 Wing. They hear these things, you know, multiple -- you V 3 know, this cancer occurs up there. l And the workers all had l 4' to. watch this tape to tell them that they have an increased 5' risk. It is a faulty study, it is very obvious. 6 'DR. GARRICK: While we have you here, because we 7- have to break for lunch here pretty soon, but what in your ; 8 opinion, both of you, has been the most important 9 advancement made in, say, the last five years in the arena 10 of understanding low dose response, if anything? If you 11 want to pick a different time period -- l
?. DR. RAABE: Twenty years?
13 DR. HORNBERGER: Well, that answers your question. I 14 DR. GARRICK: Yes.
) 15 DR. RAABE: If you go by the NCRP's newest report, 16 there hasn't been much new because they basically are 17 saying --
18 DR. GARRICK: Because this seems to be a point of 19 debate too, between the LNT supporters and the 20 nonsupporters, where the nonsupporters seem to think that 21 there's been quite a bit of work done that would be evidence
-22 of a nonlinear --
23 DR. RAAB*: d Some.of the studies that are cited by 24 some people who say that you can't believe the linear no 25 threshold are studies that just show.you can't discount the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L
i 1 411 1 possibility of no risk. They don't disprove the linear no i e (n) l'\m/ 2 threshold and there is a big difference between saying your 3 statistics are such that I can't rule out zero and saying ! i 4 that LNT is wrong. 5 Of course the Cardis study is the biggest one that 6 has been done with the most workers that I know of in one 7 study and I think very carefully done overall in terms of 8 the epidemiology and the best biomathematical methods, and I 9 know Ethel Gilbert personally. I think she is a very good 10 biomathematician. She was involved in that. 11 And what do they show? And I hehrd Ethel 12 Gilbert -- they say,'well, I am repeating myself, it doesn't 13 show anything particularly. I mean we have a very good 14 record. We can't prove or disprove anything within the ()
.rm 15 limits of statistics. They do believe there is a leukemia 16 effect but when I look at leukemia effects and I see it is 17 not consistent, it only occurred at two places, one in 18 Canada, one in Europe, didn't occur in the United States, 19 sounds like it wasn't radiation. Sounds like a confounder.
20 DR. GARRICK: Charles? 21 DR. FAIRHURST: A couple. In that period what has 22 been the support? Is there support gaining for hormesis or 23 is that something that was not considered significant 15, 20 24 years ago and it is seemingly getting greater attention or 25 greater credence? l [ ) ANN RILEY & ASSOCIATES, LTD.
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l 1 412 1 DR. RAABE: Well, I don't -- I haven't personally 2 worked in the area of hormesis. ( ). I work with data and try to 3 fit models and so forth. Now sometimes you see things that 4 look like a beneficial effect. Yes, the dogs in our studies 5~ with Strontium-90 that lived the longest were the ones in 6 the lowest dose group. l l 7 DR. FAIRHURST: But we are talking about advanced j l 8 in the last 20 years. Is there a scientific sort of l 9 credibility growing or greater evidence that it is real 10 based on basic mechanisms or basic understanding? I 11 DR. RAABE: There are a number of st(dies that i 12 have.been pointed up in'the last few years that suggest a i 13 beneficial effect of -- 14 DR. FAIRHURST: That is what I was pushing Art () 15 Upton about yesterday and he seemed to agree to it. 1 16 Could I ask quickly the other question? It seems ' 17 to me that you alluded to it yesterday somewhat. This great ' 18 variation in background, and seemingly no effect, I mean 19 what can you do with that? Apparently you can't treat it 20 statistically ? t there must be some way that evidence shows 21 there's a variation. 22 DR. KEARFOTT: That background is extremely 23 variable. 24 DR. FAIRHURST: I agree -- 25 DR. KEARFOTT: Hundred foot dimensions -- .O ANN R LEY & ASSOCIATES, LTD. (s- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
U 1 413 { 1 DR. FAIRHURST: With.no apparently correlation to t
'2 cancer.
3 l 3 DR. KEARFOTT: That's possible. 4 DR. FAIRHURST: That is what I am hearing. 5 DR. RAABE: Well, let me give you some real
- 6 numbers, okay? I did the calculation for the 100 millirem 1 V )
l- 7 per year, okay? Most of us get about 300 millirem per year,
]
l 8 'so that would predict about a one -- if you believe the l 9 linear no threshold, if you believe it is the upper limit 10 that would predict, upper limit of about 1 percent lifetime [ l 11 risk from cancer from this background level. 12 Now the average person in the United States, 13 what? -- 35 percent of the people get cancer? You can't 1 14 find that in the noise. I mean if you go to Utah, where ) 15 people don't smoke very much, the cancer rates go way down 16 but their radiation level goes up. Well, even if there was l 17 :a special increase of a couple percent in their risk due to 18 the radiation, the drop in 10 percent that occurs because i 19 they don't smoke overwhelms that. 20 DR. FAIRHURST: Right. 21 DR. RAABE: In Colorado the average dose to ; 22 people, effective dose to code, is about 900 millirem, about l 23 three times higher. Colorado is 48th in cancer in the l 24 United. States. I'have.the numbers here if you want to see 25 them. [N ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
414 1 Lung cancer, Colorado is down. Only Utah is lower () 2 3 than Colorado in lung = cancer. from radon and Utah is down there. Most of this extra dose is D.C. is 48 cancers per 4 100,000 and Colorado is 35 -- this is lung cancer in 1995. 5' So let's take the 300. Well, that would predict 6- about a 3 percent lifetime risk of cancer. We are still 7 looking at this background level. It is lower in Colorado 8 .than-here.but I don't know i:' you could statistically ever 1 9 see if that 3 percent were real. Can you see it amidst the 10 confounders? 11- DR. FAIRHURST: Yes, but can't you come to a ^ 12 conclusion that given all of the cancer-causing agents that 13 are bounding'in the world today, radiation is not a 14 significant component. () 15 DR. RAABE: Absolut:ely right. Even if you believe E16 LNT. 17 DR. FAIRHURST: The public heard that. i l 18 DR. RAABE: Even if we believe LNT, the people who -{ 19 are arguing LNT are arguing f or a very low risk and low dose 20 and the people who.are arguir.g other things -- are arguing 21 for a lower risk. 22 DR. FAIRHURST: But can I turn it another way and 23 say you are throwing billions of dollars at the LNT 24- hypothesis or protection against radiation and say for god's i 25 sake put that money into stopping people from smoking. l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I 415 j i 1 DR. HORNBERGER: You're too rational. l l [} 2 DR. FAIRHURST: Commissioner Dicus yesterday said j 3 what is the public willing -- if they are willing .o pay it, f 4 . we'll pay it I think we are not serving the public by 5 not -- I think it was one of your points -- I know your risk 6 information and risk doesn't work but there's got to be some 7 way you can inform the public of the stupidity of some of ! 8 these allocations' . Maybe I am still -- i i 9 DR. RAABE: One resoonse I have gotten from the 10 _public, I like to use comparisons. The risk of a few extra 11 millirem is the same risk as moving up a thousand feet, you 12 know, so you if you move to the mountains you are going to l 13 get the same dose, but in a discussion with the public one 14 thing I wanted to bring up was if you come up with these () 15 numbers, these numbers that we play with, they are pure 16 speculation, mind you. 17 The Health Physics Society is right. Below 5 rem i 18 you cannot come up with a quantitative value that doesn't 19 have such gigantic uncertainties that it is almost I 20 meaningless, but if you take these numbers to the public and 21 say well, you know, the risk is only three-tenths of a 22 percent of getting cancer - "Well, what about those people 23 who get the cancer?" 24 DR. FAIRHURST: Oh, sure. Sure. 25 DR. RAABE: That is what I have been told -- but O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
416 1- what about those' people who actually get those cancers? q 2 DR. GARRICK: Just to push Charles' proposal a 3 little further, if you took a place like Central City, 4 Colorado, where -- 5 DR..HORNBERGER: Where some of us have claims. 6 DR. GARRICK: -- where some of own mining 7 property - l .8 [ Laughter.]. 9 DR. GARRICK: ' -- and it's 1000 millirem or 10 whatever, and another similar location, similar population, ! .11 full time residents of course, where it is about 100, are we 12 saying that we still couldn't control the analysis well 13 enough to do a credible comparison? 14 DR. KEARFOTT: Only a good epidemiologist I think () 15. could give you that answer. 16 DR. GARRICK: Yes, j
~17 DR. RAABE: Yes, you are asking an epidemiological 18 question.
19 The question is whether you can do a case control i 20 study where you can control enough factors to reduce the
'21 background level or to control for the background level of 22 cancer and we know about cigarette smoking. That is easy.
23 But we don't know about other things and so I don't know. 24' That is zul epidemiological question.
- 25. DR. KEARFOTT: But it sounds like a hard one.
l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ) (202) 842-0034 !
l' l 417 l 1 DR. GARRICK: But they have pretty good [) G 2 information on some of these things, like you say -- like
'3 cigarettes. We seem to know everybody that smokes in the 4 United States.
5 DR. HORNBERGER: Yes, but my suspicion is that . 6 perhaps if Central City were the size of New York City that ! 7 you might have a chance but when you have a few hundred 8 people living in Central City, even on the sample size basis 9 you are going to be really -- it's tough, and that is not l 10 the hardest part of the problem. 11 I still think they have these controlling for lots 12 of other things. 13 DR. GARRICK: Well, it's unfortunate that we have 14 a phenomena that is so easy to measure as radiation and we
'N
,) 15 have so many measurements as we do on it that we can't do a 16 better job of answering some of these questions, but I guess 17 you have convinced me of the problems.
18 All right. I guess the other thing I would ask is 19 sort of in closing of this session are there any other 20 comments that you would like to make, nuggets that you have 21 rethought? 22 You have given us an xcellent discussion of what 23 you have observed from the 62 sions of the last day plus, 24 and it looks like it is pretty much now up to the committee 25 to figure out what we want to say about this, but before we ! /~ ANN RILEY & ASSOCIATES, LTD. !5 l
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418 1~ do adjourn this segment, I appeal to you if there is any 2' other parting observations or comments that would help us. (} 3 4 DR. RAABE: I would like to repeac s 'hing that 5 I mentioned in passing. You asked earliel 2" ve needed
~6 another study.
7 DR. GARRICK: Yes. 8 DR. RAABE: If someone said, you know, do you need 9 another study, I'd say well, you know, I would really like 1 10 to see a study where the Committee has a charge to look only 11 at protracted radiation and try to piece together all that 12- you know about protracted radiation exposure. I think ( 13 that's the target of our problem, it's the source of our I 14 . problem. () 15 I also like the idea of doing some targeted 16 -analyses of' specific radionuclides. I 17 DR. GARRICK: Yes. 1 18 DR. RAABE: All that we know about plutonium, and i 19 don't leave out the animal data, because there isn't any 20 human data. It always puts me in shock that we spend all 21 these multimillions of dollars on very-elaborate animal 22 studies, and when you read the reports that are being 23 produced, to a large extent that information is.not used. 24 DR. GARRICK: Yes. 25 DR. RAABE: And usually it's this hidden idea k' ANN RILEY & ASSOCIATES, LTD. Court. Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
b 419 1 well, you know, human data is more appropriate, you know, 2 animal data is animal data, you know. So although the < sm 3- animal data.are really well controlled and the human data 4 are not, and the animal dosimetry is very precise and the 5 human data dosimetry is very imprecise, to not use the 6' animal data -- anyway, that was my main thing about the f i i 7 protracted and the targeted radionuclide. 8 DR. GARRICK: Kim. 9 DR. KEARFOTT: I tend to be naively optimistic in l 10 that there must be some opportunity, somewhere, to break the ( 11 ' box. And I was very sort of captured by Dr. Fairhurst's
, 12 comments about the public and, you know, can't you do this 13 another way. So somehow there has to be a way of taking.a
'14 different-approach to analyzing and presenting the data that
() 15 16-we already have and have a truly independent group figure l out how to synthesize things. And I think that's the only l l l 17 way we'll break a box in which one of the walls in the box 18: is the public and the other wall in the box are the j 19 technical people. 20- DR. GARRICK: And I think that complements exactly i 21 what Dr. Raabe just said, and all we have to do is figure 22- out who. 23 DR. FAIRHURST: Could I throw out -- 24 DR. GARRICK: Yes. 25 DR.'FAIRHURST: One even more extreme thing. You, f ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue,RNW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
420 1- ~ I've actually talked -- do you know a fellow named Crows at p 2 the University of Wisconsin who is looking at projections? 3- It's always interesting to me to see how people project
.4 data,-et cetera, and'if it has a negative effect, you keep 5 it in, and if it seems to have a positive effect, you say.
6 well,'you know, that's a bit too -- let's push it out, 7 because.-- one of the things that's interesting, that if 8 you're -- there's a big stimulus now to do fundamental 9 biological research on the causes of cancer or the effects 10 on DNA, et cetera. Now presumably if you discover this 11 research is fruitful, not only will you be understanding 12 perhaps the causes of cancer,. but possibly ways to reduce 13 its impact, or I wouldn't call it a cure, but somehow to put 14 preventative. And so -- and the next thing of course is, as () 15 16 you say, that people ultimately die of old age, and if you push the age out, presumably you're eliminating other 17 diseases and leaving one of the most intractable cancer 18 to -- tend to increase the percentage of people dying. 19 But if you start using similar sorts of logic, if 20 you like, or illogic, to extend, what's the reality that the 21 causes of cancer will be a major component of a problem 50
- 22. or 100 years from now? Do you see what I'm saying? If we 23 are pushing this research, and it should be done, and if 24 it's successful, then you're eliminating the problem, or 25 partially the problem, even if you do have -- you find out O ANN RILEY & ASSOCIATES, LTD.
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r-421 i 1 that there is a high consequence of a dose 50 years from
/'T 2 now, you may be able to offer that person some remedial j L) 3 treatment. And I'm trying to figure out how you put that 4 into --
5 DR. RAABE: It's sort of like the case with 6 thyroid exposure. We know that people might have gotten 7 high doses of I131 years ago, but thyroid cancer's almost 98 8 percent curable. Is that what you're saying? 9 DR. FAIRHURST: Yes. 10 DR. RAABE: And presumably for other kinds of
]
i 11 cancers there are going to be even more fantastic methods ! 12 for treatment. 13 DR. GARRICK: In fact, the health effects models 14 that we've used before the NRC got into the risk business (n) 15 were based on essentially that, that 90 percent of the 16 thyroid cancers were recoverable. 17 It sounds like the ode of the radiation researcher 18 is to want to live long enough to have died from 19 radiation-induced cancer. 20 { Laughter.) i 21 DR. RAABE: When I give the talks on the studies I 22 did with internal radionuclides, I always point out that if 23 you removed all other causes of death, you would eventually 24 die of radiation-induced cancer. 25 DR. KEARFOTT: I just wanted to comment that the
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! 422 1 treatments depend on understanding of the inechanisms, and so
/-
2 that's why I support continuing sort of biological research, (\ j 3 because that's where those answers are going to come from. I 4 DR. GARRICK: George? l 5 DR. HORNBERGER: Yes, a question again, sort of a 6 hypothetical -- well, it's not hypothetical, but it follows l 7 a little bit on what Charles said. l 8 One of the things that we're grappling with right l 9 now is of course Yucca Mountain, and here we'rn talking l 10 about setting standards out at 10,000 years and beyond. 11 Currently the draft standards call for a 25-millirem j l 12 all-pathways standard, and as you've heard, there are some 7.3 arguments with EPA as to whether or not that is or isn't the 14 right standard. Could you just give us your -- even if it's l /~N i, ,) 15 a gut-level feeling -- on what a standard -- a reasonable 16 standard, radiation standard, should be for that kind of 17 problem over that kind of time frame. 18 DR. RAABE: Well, there is no basis for saying 19 that 25 millirem is different from 15, that is for sure. 20 The Health Physics Society's position statement is 21 that you can allow 100 millirem per year, and I stand with 22 that. I don't think there is any known or expected risk at 23 all. Protracted exposure -- l 24 DR. HORNBERGER: So, 100 millirem at 10,000 years, i 25 that seems reasonable. i [\~ /) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 ! (202) 842-0034
I 423 1~ DR. RAABE: Sure, i () 2
'3 DR. GARRICK:
DR. RAABE: All pathways? All' pathways? 4 DR. GARRICK: Yes.
.5_ DR. RAABE: Yeah. I don't think there is any 6' known expected risk associated with that kind-of exposure. l i
7 .DR. KEARFOTT: I_also support Health Physics 1 i 8 Society's-statement in there. 9 DR. FAIRHURST: You know that the significance of 10 that with' Yucca Mountain is that DOE's own studies show that 11 the ri'sk is -- or the does is rising beyond 10,000, even 12 .though we set our standard at 10,000. And so the public is 13 going to go jumping through the roof if you, say, set it at
-14 a time-when it is not the worst.
/~s 1 15 DR. KEARFOTT: I have a terrible problem with this 16 whole sort'of long-term waste stuff, and that I view 17 internal dose assessments and the number I can give for you 18 next year has an order of magnitude uncertainty in it, when i
- 19. you take everything into account, and then you tell me to !
l 20 extrapolate 10,000 years, I mean that is the problem I have i 21 with all that. 22 DR. GARRICK: Well, that is a valid problem. What . 23 I would-Aike to do is invite our consultants to enjoy this L -2 4 - afternoon with us if you like, in a slightly different I i 25 po'ition. We are going to hear some presentations on the ANN RILEY & ASSOCIATES, LTD.
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F 424
'l clearance rule and also on the decommissioning standard
[')- V 2 review plan. I don't know what your travel plans are. I 3 just want to indicate that you are welcome to be here if you 4 are going to still be in town. 5 Any other parting comments before we adjourn for 6 lunch? This has been an excellent session and I think it 7- has coalesced a number of ideas and pointe that gives us a 8 basis for trying to work up some sort of rational report. 9 Dana, have you got a parting remark? 10 DR. POWERS: I guess maybe a couple of questions. 11 One question, a lot of research was outlined that could be 12 done. Have you any idea why it is that the industry that 13 bears such high costs is not an active sponsor of research 14 in this area? The second question would be, have you seen f~% iv) 15 anything that refutes the logic that we can set a standard 16 cf what is safe enough, utilize a linear hypothesis that may i 17 or may not be bounding, and set risk standards based on 4 18 that? 19 DR. RAaBE: The first question was -- 20 DR. POWERS: Industry. 21 DR. RAABE: The industry. I don't know anything 22 about that. 23 DR. KEARFOTT: I suspect that it might be because l 24 industry doesn't want to fund very long-term purely l 25 scientific research, particularly an industry whose main l r (}
'% /
ANN RILEY & ASSOCIATES, LTD. Court Reporters , 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034 l
g i I I 425 1 focus is power. s
- 2. DR. GARRICK: Why don't we ask Ralph to make a
, (w_-) 3 comment? What you got to say about that, Ralph? 4 MR. ANDERSON: My name is Ralph Anderson with the i 5 Nuclear Energy Institute. I am sorry I couldn't join you 6 this morning, I was very busy at our offices help prepare i i 7 our final testimony on appropriations for this year for DOE 8 and NRC, and the reason I had to stay behind is because we 9 were completing our section of the testimony that is 1 10 supportive of the DOE research funding and encourages ' 11 continued research in this area. ) 1 12 So, first of all, I think the statement is 13 incorrect. And, in fact, last year and the year prior, we 14 had many interactions with Senator Domenici's office in () 15 16 which we were very supportive of his vision for research in this area. So I think that is a misunderstanding of 17 industry's position. 18 Also, through EPRI, which is our research arm, we 19 have, in fact, invested money in the past to do feasibility 20 studies of epidemiological studies, and primarily because of I 21 economic reasons, and because we also reached the conclusion ' 22 that the studies would not be definitive, we determined not 23 to go forth. But I think that is reasonable in any mode of 24 research, you don't proceed with research that you don't 25 expect to be fruitful, especially at e potentially high I l l} ANN RILEY & ASSOCIATES, LTD. (_,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
[. L 1 L i I 426 l . i
. 1. cost. So I think that there is a misunderstanding of L
2 industry's position on such research. [ 3 DR. KEARFOTT: The second question -- i 4 DR. POWERS: Am I misunderstanding that you are 5 not funding any research in this area, especially this 6 litany that was given to us? I ( 7 MR. ANDERSON: I beg your pardon? ; I 8 DR. POWERS: Am I misunderstanding that you_are 9 .not funding research, especially in this litany of research 10 suggestions that we have had? 11 MR. ANDERSON: When you say we funding, I am not l i 12 sure what. opportunities for funding we specifically have. 13 DR. POWERS: Well, it seems to me that there are 14 apparently.a large number of people in the a'cademic (f 15 community wiling and anxious to conduct studies ranging from 16 cells in petri dishes up to epidemiological analyses. ) 17 MR.. ANDERSON: I am sure that is probably true, i 18 having worked once upon a time in the research community, 19 and not to make light of what you say. I suspect there are I 20 probably thousands beyond those that we are aware of. If 21 you are suggesting would we directly fund such research 22" through the universities, I suspect not. We might encourage 23 such funding through federal funds, and let me tell you why. 24 What we ascertained in '92 when we looked at going i
-25 . forth with an industry funded large scale effort on /'Ng ANN RILEY & ASSOCIATES, LTD. -(_/
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427 1 epidemiology, one of the conclusions that we reached after 1 j l (~')
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2 talking with a lot of the people who were so-called 3 stakeholders out in the public community was that any study 4 that we funded would be found highly incredible unless the 1 5 results were that all radiation kills all people. And so, 6 in that sense, we have done indirectly, we support the NCRP, ) l 7 we have for years. We have given money to specific efforts 8 at NCRP. As I mentioned, we have supported primarily 9 literature reviews through EPRI, subsequent to our '92 10 decision. And then we work through the Congress, because we 11 think that an understanding of the issue actually is a 12 little broader than, quote, "just the industry." We think 13 in the public interest to have better answers to the 1 l 14 questions. And, you know, we have been very supportive of (n
~-)
i 15 research through federal monies. 16 But I think we would shoot ourselves in the foot 17 if we were to try to pass money directly over into the 18 research community. It just seems to pollute the well. I 19 would be happy to talk furcher about it, but that's -- 20 DR. GARRICK: Okay. I think we want to -- I guess, 21 James, you have one final -- 22 MR. MUCKERHEIDE: Over the last 20 years or so, I 23 have talked to the industry about funding research. It has 24 always struck me as very surprising, but quite rational why 25 industry does not research. As a regulated utility (~N ANN RILEY & ASSOCIATES, LTD. (__f Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
428 1 environment, two things were fundamentally true. In their (R v/ 2 regulatory process, they got some money to support EPRI in i 3 the early days, but compared to chemical industry or oil 4 industry, or any of the other private industries, they ! 5 didn't have the same approach, nor did they have the same i 6 incentives. 7 Number two, they were party to a government 8 ownership, essentially, of the nuclear enterprise. They 1 l 9 were licensed and regulated under very rigid conditions, the ' 10 ownership and the responsibility under the licensing regime, 11 and the authority for byproduct materials and lots of other 12 issues were all very -- pretty much closely hidden by -- 13 held by the government, and so there wasn't a sense that 14 there was something to do. s (_) 15 Thirdly, it was very clear that if we have to 16 spend a great deal of money to meet a requirement, we pass l 17 it through to the rate payer, so some of the issues that we 18 addressed in the '70s and in the early '80s were pretty much 19 set aside as, well, if we have to pay another $100 million, 20 we just put it in the rate base. 21 And, finally, in more recent times, I think if we 22 begin to see this industry become more privatized, the 23 potential that they will join the arena of industries that 24 actually fund research, I mean we have a chemical industry l l 25 Institute of Toxicology. There is no nuclear industry ' l O ANN RILEY & ASSOCIATES, LTD. ss Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
429 1 Institute of Radiobiology. There is an entire world of () '2 programs that chemical industries and other industries fund 3' relative to their own self-interest, but being a
.4 quasi-governmental regulated enterprise, primarily, it just 5 never really was in their interest. So I think one of the 6- things we hope to see change is under the new tendency to be 7 more privatized, that the interests will begin to revert to 8 'having more self-interest;and seeing long-term research and 9~ long-term-interests come to the fore.
10 DR. GARRICK: Yes, and I think, fundamentally, 11 unlike the chemical industry, the automobile industry, many 12 other industries, the nuclear power industry had its 13 beginning in a' government' arena where most of the research 14 was performed by.the government. () 15 Okay. I think we will break now for lunch. 16' [Whereupon, at 12:05 p.m., the meeting was 17 recessed, to reconvene at 1:02 p.m., _this same day.] 18 I i 19
]
20-l l 21 j 22 i 23
'24 25 ANN RILEY & ASSOCIATES, LTD.
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r 430 l 1 AFTERNOON SESS ION 2 [1:02 p.m.]
!nv) 3 DR. GARRICK: The meeting will come to order, i 4 We are now going to shift into a little different 5 area of activity. We are going to hear about the Clearance l l
6 Rule and also about the Decommissioning Standard Review Plan l 7 this afternoon. l 8 It is my understanding, Frank, that you are going 9 to lead off the discussion and I will look to you to 10 introduce the subsequent speakers, okay? Frank Cardile. 11 MR. CARDILE: Go ahead and put the next slide up, ) 12 Giorgio. i 13 Basically this is just an introductory slide on l l 14 page 2. We are here to talk about -- we are here to kind of l n (~, ) 15 lay out the progress of where we are in development of a l 16 Clearance Rule, basically, as it indicates here, give some 1 17 background, indicate where we are, the recent activities 18 that we have gone through and completed, what are our 19 upcoming steps, what is coming up next that we, the l 20 activities that we are going to be conducting. 21 Then we will get into some specifics of an issues 22 paper that we have completed and that we are going to be ; 23 sending on to the Commission shortly, and then Tony Huffert, 24 to my left here, will discuss some particulars with regard 1 25 to development of a technical basis that we are going to use ! i ( \ ANN RILEY & ASSOCIATES, LTD. (_) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 ! (202) 842-0034 i e
f l 431 1 to support any rulemaking effort that we get into. 2 ' f)a w We are trying to let you know wher's we are. We 3 have made a lot of steps here fairly recently and we have 4 got a lot of steps going on in the next few months and year 5 and we want to let you know what is going on. 6 On the next slide, on page 3, to give you some 7 background on how we got to where we are, in SECY-98-028, 8 which was sent up about a year ago in February of 1998, the 9 Staff went to the Commission and requested Commission 10 guidance or direction on three options for how we should 11 proceed with regard to clearance, that we could either 12 continue with our current regulatory structure, which 13 basically relies upon the use of regulatory guidance, or we 14 could support EPA in their efforts at issuance of a standard ( 15 on clearance, and then follow them up by issuing a 16 confonning rule or we could proceed independently to issue a 17 NRC rule for NRC licensees. 18 The Commission came back in June of 1998 and 19 directed us to proceed with the thiid option that you see up 20 there, the third bullet, and that we should promulgate a 21 dose-based rule on clearance, we should begin in FY 1999, 2 and that we should use an enhanced participatory rulemaking 23 process similar to Part 35, the process that they have gone 24 through and also similar, although they df.dn't mention it or 25 they didn't specifically delineate it, similar to the O ANN RILEY & ASSOCIATES, LTD. l/ [ 5._ Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
432 1 process that we went through on the decommissir'. ling rule or f'} v 2 the cleanup rule in 1992-93 timeframe. 3 So with that direction, if you go on to the next 4 slide, on page 4, the Staff received that S'RM in June of 5 1998 and proceeded with a number of steps to get started and 6 then on January 27th of this year, 1990 we sent up to the 7 Commission a SECY paper, SECY-99-028, describing to them our 8 rulemaking process that we envisioned for clearance. 9 Included in that process, and not specifically 10 noted on the slide here, is that we were forming a working 11 group and a steering group on clearance, on the clearance i 1 12 rulemaking effort. The purpose of the working group and 13 steering group is obviously to assist in the preparation of 14 the document. The working group would be made up of working ,f-s ( 15 staff from NMSS, NRR, Office of State Programs, OGC, and 16 Research. Obviously this is a wide effort going across both 17 licensing offices, NRR and NMSS, also the Office of Research 18 plays a role in assisting with the development of the 19 technical basis to feed into the rulemaking. 20 OGC of course provides the legal input and OSP 21 provides input with regard to compatibility and other areas. 22 The steering group -- in addition to those members 23 of the working group we also have a working group member 24 from an Agreement State, from the state of Texas. We also 25 set up a steering group made up of management from those (~} ANN RILEY & ASSOCIATES, LTD. Court Reporters (_/ 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
433 1 'particular NRC offices to give us early management direction f
/~% on some particular areas and also to expedite the lb
~ 2
- 3. concurrence process.
4 This working group-steering group process has been j 5 used and was used also on the cleanup rule, which was l-6- completed a couple years ago. L 7 We also have a steering group member from the 8 state of Illinois, an Agreement State, so we have some state 9 representation on this panel, on both of these panels. 10 We also are proceeding with not only -- as part of 11 our rulemaking process not only the standard rulemaking 12 procedure but we also, as the Commission directed us to do, 13 are supplementing the process with an enhanced participatory 14 rulemaking process the object of which is to obtain early () 15 and meaningful public input into any rulemaking that we 16 would conduct. 17 As noted'there then, on the first bullet, really 18 this first bullet describes some of the specific plans with 19' regard-to this enhanced participatory process. Two of the 20 key componenta of that. process are that we would publish an 21 issues paper in the Federal Register. T will talk about
- 22. that some more as we are going on to the next slide.
23- Basically this issues paper will go out there and 24 be published in the Federal Register and its intent is to 25 foster discussion on the issues associated with any p ANN RILEY & ASSOCIATES, LTD. Court Reporters l s_) 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
434 1 rulemaking early on, so that we know -- we can get some 7
'2 information.
3 We also hold four facilitated public meetings at 4 different geographical locations. We anticipate those l. 5 .beginning in August of this year and' going through November 6 ~o f this year. Right now we anticipate those meetings being 7 in Chicago, Atlanta, San Francisco, and Washington, D.C. 8 The last one would be in Washington, D.C. l 9 We would invite the ACNW members to attend any of 10 those public meetings and in particular we also anticipate j 11 that in the timeframe of those public meetings, either in
- 12. amongst them when we can reflect what we have been hearing, 13 or perhaps when we are done with -- when we are completed l
14 with the public meetings we would hold a meeting with you to () 15 go over your-views on the specific content of the issues 16 paper. 17 The idea -- you may be familiar with a-facilitated 18 meeting. The idea of facilitation is to not only just hold l 19- a meeting and uay what are your views, but to broaden 20 participation to make sure that different views are 21 represented and to make sure that the view that are 22 represented are presented at the meeting, so it is not just l 23 open up the door and hold a public meeting but there is a l l 24 process that we go through prior to that where we invite 25 ~ specific interests and then we let them know early on what ANN RILEY & ASSOCIATES, LTD. [N-- Court Reporters 1025~ Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
! l 435 1 the questions are and bring these interests into the l (en)
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2 meeting. 1 I 3 We are in the process right now. That process of I 4 facilitation will be one in which we both contract out some 5 of that work and also use a person here, Chip Cameron, who 6 has done this type of work at Part 35 meetings prior to 7 this. 8 The second bullet on the page, going back to the 9 content of that Commission paper, we discussed the specific 10 technical basis that we will still need for this rulemaking 11 the schedule for developing that technical basis. 12 Tony Huffert later in this paper, Section 4 your 13 notes here today, will be talking to some of the details 14 about that technical basis. (3/
% 15 In broad terms, we are right now in the process of 16 getting on board the contractors that we need to assist us 17 in that process. We plan to have those contractors on 18 board -- there's four separate contracts and four separate I 19 contractors. One is a competitive bid. One is a task order 20 on an existing bid. Two are with Government contracts. But 21 we plan to have them all on board and running shortly and 22 certainly completed by either June or July of this year that 23 they would all be on board.
24 Finally, the last bullet on this page, the SECY 25 paper indicated that following completion of the public ANN RILEY & ASSOCIATES, LTD. iI\w-)/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 1 1 436 1 meetings that in probably February of next year we would ) (,,) '2 bring the Commission another paper indicating the results of l
%J 3 the meetings, where we stand on the meetings themselves, and 4 what we learned from those meetings, and then also where we 5 stand on the development of the technical basis and where we 6 would go from there.
7 Okay. The next slide as the first order of business are 8 preparing this issues paper. The point of the issues paper I 9 is to, as I said, foster discussion on the issues before we 10 would get into any rulemaking. l 11 This Saper has been completed. It's currently in ! 12 NMSS office, concurrence process, the various offices and 13 the steering group members have concurred on the paper. We 14 plan to send it to the Commission for information this
) 15 month, and then we plan to publish it in the Federal 16 Register for public comment next month, in April. We would 17 invite. written and electronic comments on it. We will 18 indicate in it how it can be obtained, both electronically 19 and how paper copies can be obtained from the staff.
20 The comment period of the paper will remain open 21 until of course the last public meeting in November, and 22 then we would also note in the FRN notes that the issues 23 paper not only being available for people who have sent in 24 their written comments but it will be the format of holding l 25 the public meetings. l t
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1 l 437 1 Following the public meetings of course we'd be in ( 2 a better position to decide what direction to proceed. 3 So getting into the details of a little bit of 4 what's in the issues paper, on page 6, the next couple of 5 slides, what we did in the issues paper is we had a 6 background section in which we try to lay out in as direct 7 and clear a manner as possible where we are now, why we're 8 doing 'ihat we ' re doing, why this is different than what 9 we've ever done before, and what we plan on doing, some of 10 the context of why we're doing what we're doing. That's 11 Part A of the issues paper. Part B of the issues paper is 12 ask some specific questions -- it raises four specific 13 issues, lays out alternatives under each issue, and then 14 aaks some specific questions to foster discussion in these () 15 public meetings. 16 So this first page here that you see, page 6, is 17 part of the background, discusses some of the rationale for 18 why the NRC is considering rulemaking in the area of
- 19 clearance. Basically it notes that Part 20 already contains 20 criteria on the amount of radioactivity and gaseous and 21 liquid releases that may be released from a nuclear facility 22 to the environment. Also subpart (e) of Part 20, which was 23 recently added, has criteria on the release of 24 decommissioned lands and structures.
25 This part focuses on protection of persons -- n g_s ANN RILEY & ASSOCIATES, LTD . Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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l' 438 L 1 focuses on protection of persons coming on the site and j ' ("%[ 2 using a decommissioned-structure or using decommissioned l j
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l 3 . lands after license termination. It does not focus on i j l l. 4 release of metals or other equipment or other things from 5 -the decommissioned structure to the public. So it was 6 focused on the structure and the lands. l l 7 However, unlike -- like I point out here, the 8 existing criteria for liquid and gaseous releases and lands I i 9 and structures, there are no specific criteria in Part 20 10 governing releases of solid. materials. Now I don't get into 11 this here, but r.he issues paper discusses in some amount of l 12 detail or provides some information about what these solid l 13 materials are. It notes that the solid materials are, for j 14 exampls, metals, equipment, furniture, and any other () 15 16 material that could be at a nuclear site. ; It also points out that some of this material 1 17 would have no radioactive contamination, for example, many, 18 many of the NRC licensees or sealed-source users have l 19 equipment and materials that have no contamination because ! 20 their source is a sealed source and there's no contamination 21 on site. But it points out that other materials obviously l 1 l 22 .at some other facilities can become contaminated because 23- they're in perhaps like a reactor facility or a laboratory 24 facility where there's contamination which may leak from a 25- pipe and particular equipment may be there and become [~% ANN RILEY & ASSOCIATES, LTD. (s ,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L.
439 1 contaminated, or obviously if a piece of equipment is part () 2 3 of the radioactive system, like a tank or piping or pump systems, those would obviously become contaminated. So the 4 paper tries to point out that there's a difference in levels 5 between the amount of contamination that any particular j 6 piece of material can have. j i 7 The bottom line or the bottom tick on this page is j
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8 that the Commission's thought is that in order to provide -- I 9 the rationale is that to provide consistency in the 10 framework for releases of all materials we're considering l l 11 this rulemaking. 12 This would put us in a better positicn to avoid 13 inconsistencies between standards and also allows us to deal 14 with requests from licensees, especially in the future. As (~~) ( 15 more facilities reach decommissioning, there may likely be 16 increased requests for clearance. 17 On the next page, on page 7, again this is more 18 background, the issues paper notes that anytime the 19 Commission proposes a rule or considers proceeding towards 20 rulemaking, it considers alternative courses of action. 21 Three of the courses that we lay out in the issues paper as 22 possible courses of action, and again this paper is intended 23 to foster discussion. It says that these are the things 24 we've thought about based on our knowledge that we have, and 25 obviously this is a jumping-off point for anyone else -- or I
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I I 440 j 1 for anyone to say either changes or suggestions or r~ (Sj 2 permutations to these courses of action. 3 Basically the three alternatives that we lay out 4 are permit release of the materials for unrestricted use if 5 potential doses are below a certain level. This level 6 obviously would be worked out during the rulemaking process. 7 The process that we've been using this word " clearance" and 8 " unrestricted use" back and forth a little bit so far today, 1 9 and it has been used back and forth. l 10 As you may well know, internationally the 11 definition of clearance is release of material for 12 unrestricted use, so that clearance would be restricted to 13 the -- or would be used for this first alternative. Because 14 this rulemaking is proposing or this effort is proposing p) (, 15 alternative courses of action besides just unrestricted use, 16 we have to be careful not to just call the whole thing 17 clearance. But anyway, unrestricted use or clearance of I 18 materials could include recycle or reuse of this material i 19 Cnto either consumer products or industrial products, or you 20 could just release material for unrestricted use and it i 21 could wind up in a landfill.
- 22 A second alternative that we note is that perhaps 23 rather than just putting the material out for any use, we 24 could restrict its use to certain authorized uses which 25 would probably result in the public receiving -- the general w
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l 441 1 public receiving lower doses. ! <~s i /
) 2 And a third possible option is that neither a
3 unrestricted nor restricted use would be permitted, but any 4 material that had been in radioactive service or had become 5 contaminated because it had been in an area where material 6 was used -- licensed material was used or stored would just i 7 not be permitted to be released. This is a third option 8 which we indicate in the paper. 9 Going on to page 8, again in background this is 10 something that we obviously are aware of. , l 11 There have been previous Commission efforts to l 12 address release of solid materials. In particular the BRC 13 policy from July 1980, you know, you can read the details of 14 what the BRC policy was intended to do, but it basically was (h i ,) 15 a broad policy statement saying -- put out as a way around 16 which to formulate future decisions regarding regulations or 17 licensing decisions. 18 It has four principal components, one of which was 19 decommissioning lands and structures, and another one of 20 which was setting a standard for release of solid materials 21 for recycle. Notice that it only talked about recycle, 22 didn't talk about clearance in general, which can mean also 23 general release or where material could wind up in a 24 landfill. 25 However, based on, you know, public concern with ANN RILEY & ASSOCIATES, LTD. l [A /) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
442 this policy, some of that public concern being just the () 2 nature by which it was developed and some of that pnblic 3 concern being the content of that paper, the Commission 4 decided that a more extensive public involvement process 5 should be followed with regard to the policy, but before 6 that larger process could occur, the -- and so the 7 Commission put a moratorium on the policy. Before any 8 additional work or public involvement could be conducted, 9 Congress enacted the Energy Policy Act of 1992 which revoked 10 the BRC policy statement. 11 Moving on to the next, on page 9, continuing with 12 regard to the BRC policy, it's our thought that what we're I 12 doing now is not just the BRC policy -- that was a broad 14 policy-setting approach -- this effort would aim at () 15 establishing some specific requirements and would aim at 16 'using the procedural requiremenes of the Administrative 17' Procedures Act or the APA, as noted in the second check 18 here, The APA of course requires us.to go through the NEPA 19 process, which would include an evaluation of the j 20 environmental impacts associated.with any clearance 21 rulemaking, which would include a full assessment of 22 potential scenarios and pathways of exposure by which people 23= might become exposed to clearance pathways. ; 24 The APA or our process also involves doing a 25 regulatory analysis consistent with Executive Order 12991. O . ANN RILEY & ASSOCIATES, LTD. Court Reporters
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443 1 And as a supplement to the EPA process, we would conduct an
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[V ') enhanced participatory rulemaking process. 2 This APA/EPR 3 enhanced process was conducted in a similar manner 4 following -- has been previously conducted -- following the 5 BRC policy being revoked, one of the components of that 6 policy, namely the decommissioning lands and structures 7 component, was -- we went through a rulemaking - . enhanced 8 participatory rulemaking process on that in which we held 9 public workshops. We put out a proposed rule -- an early 10 draft of a proposed rule for public comment, and then went 11 through the rulemaking process so that in July of 1997 we 12 issued a final rule on decommissioning of lands and 13 structures which now gives NRC licensees as well as NRC 14 clear direction on how to review decommissioning of lands ( j 15 and structures, and it also gives the public clear 16 information on how NRC conducts its business with regard to 17 decommissioning lands and structures, and also what avenues 18 are available to the public with regard to being involved in 19 an individual licensing situation or case for 20 decommissioning of a particular facility. 21 So the point being that this APA/EPR enhanced 22 process was conducted for the decommissioning process, and 23 the process was completed in 1997. 24 Moving on to the next slide, that was all 25 background, we finally now get to the four broad issues that 1 1 ANN RILEY & ASSOCIAS.SS, LTD. s_s/ Court Reporte:s i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
444 1 we are going out to the stakeholders with to get stakeholder
~
2 views on. Again we want not only stakeholder comments, but (~ h] 3 we're also asking for stakeholder information. If people 4 have some information about some of the things that are in 5 here, and we'll talk about them a little bit, that's part of 6 what we're going out to get also. 7 And again, as I noted earlier, this comment period 8 on the issues paper will be open through November. The 9 paper we hope will be in the Federal Register in a few 10 weeks, after going through the, you know, sending it to the 11 Commission. If, again as I noted earlier, we would probably 12 come back to you and get your specific views on particular 13 issues, today our hope is that we can point out what we are 14 laying out there is what some of these issues and what some i () 15 of the questions that we're raising are, but after you have 16 more time to digest them, we could come back to you later 17 this year in amongst the public meetings and have another 18 meeting. 19 Again, the structure of the issues paper is that 20 it lays out the issues, it lays out a couple of alternatives 21 under each issue, and then it asks several questions under 22 each alternative or each issue seeking advice or information 23 or input from the stakeholders. 24 The first issue on this page, issue number 1, is 25 the broad question of whether we should even have a rule. l ANN RILEY & ASSOCIATES, LTD. ('}/ N ss Court Reporters - 1025 Connecticut Avenue, NW, Suite 1014 l f Washington, D.C. 20036 l (202) 842-0034 l
445 l l- 1 There's some question -- there are questions raised as to l ( 2 well we don't want a rule or, you know, why should there be 3 a rule at all in this area. And so the first issue, even 4 though the Commission directed us to prepare a rule, we j 5 thought it was important to address this issue.by laying out l 6 the pros and cons of whether we should continue with the 7 . current case-by-case approach or conduct a rulemaking under I. 8 '.the.APA. l- 9 Moving on to the next issue which gets to needing 10 a little more detail. This is where we have the substitute 11 page, I don't know if everybody got it. Basically, all the 12 substitute page does is it tries to be less busy than the 13 page that was in the stapled package. It is the same 14 information, it just cuts it'in half, or puts one thing on f 15 each page. 16 As you.can see here, Issue Number 2 asks, what are l 17 the principal alternatives for rulemaking that should be ! 18 considered? It lays out, again, as we did earlier in the 19 background, three potential alternatives, one being j 20 unrestricted use at different potential dose levels, or 21' above background, or even no dose above background. These 22 laying out of different alternative dose levels, including, ! l l 23' basically, a background level, is similar to the process 24 that.we did for the cleanup' rule, which we analyzed -- which l 25- we asked for public comment and also analyzed in the ' i O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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446 l -~ 1 Environmental Impact Statement, both a return to background i ( 2
) at the site, as well as different alternative dose levels I 3 that a site could be released at.
I 4 We also list here the other alternative of I 5 releasing material for unrestricted use or not permitting i 6 any release of solid materials. And the third check is 1 7 other as suggested by comments. Actually, when they went 8 out with an issues paper for the cleanup rule back in 1992, 9 one of the things that came back -- when they put out the 10 issues paper, there was not a restricted release option, so 11 that is why this other check here is important, because we 12 may get some options, suggestions made in public comments 13 that would add to the list of alternatives. 14 Going on to the next page, that gets into -- tries 15 to get into some of the details about what factors should 16 NRC be using in making its decisions between alternatives. 17 The first being the human health and environmental impacts. 28 We talk about -- the paper talks about looking at assessment 19 of, obviously, impacts to individuals, but also assessment 20 of impacts to different population groups, and the paper 21 also talks about the fact that there can be competing 22 impacts, so that just by having a lower dose criterion, l
.s which obviously lowers -- a lower dose criterion for cleared
, 24 material, while that obviously lowers the dose impact for 1 ! 25 p exposure to that material, there could be a competing t im ' lN/ i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
447 1 impact, that because you have to -- now, all that material, (A) v 2 rather than going into clearance goes to, say, low level 3 waste, the replacement of that fresh material, or that 4 material with new~ mined material would have impacts 5 associated with that. l 6 So we had a similar -- I keep referring to the l 7 cleanup rule, but we had a similar situation there. And so 8 what we tried to do in the Environmental Impact Statement 9 was balance both impacts that went down against impacts that 10 -go up. So that would be what we would be doing and we would 11 be asking -- the paper asks specifically, what are 12 -suggestions "or making this balance and what are some of the 13 other impacts that are competing, both radiological and 14 non-radiological? ) () 15 We also will be doing a cost benefit analysis
)
16 using NUREG BR-0058, which is the guidelines for -- NRC's 17 guidelines for complying with the Executive Order. We would , 18- be looking at all -- we would be looking, as part of this 19 balancing, we would be looking at the costs of the whole 20 process by which material would be cleared. We would be 21 looking at the cost of surveys at the different dose levels 22 that you see here. We would be looking at possible impacts, ! 23 economic impacts on the scrap metal industry. Is there_a l 24 potential that we would -- that alarms would be going off 25 causing material to be rejected and sent back,. and what i ANN RILEY & ASSOCIATES, LTD. i [N- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
F 448 1 possible economic impacts are associated with that. q [) Ns' 2 We would be looking at implementation l 3 considerations. Tony will be getting into some of this in 4 more detail in a few minutes. The implementation l 5 l considerations, of course, would include -- what are the j 6 questions or concerns about surveying large quantities of l 7 metal at these low dose levels, or even at dose levels near i i 1 8 background or at background? ' 9 As I just noted, rome of the answers to these 10 questions, like on the implementation or the environmental 11 impacts, we will be developing in our work, but we are also 12 asking the public to provide input to help answer some of
.13 these questions. And we will be looking at other 14 international, national and state standards, f^s (v ) 15 Going on to the next slide on Issues 3, we will be 16 -- Issues 3 in the paper tries to flesh out a little bit i 17 more information, or a little more detail about the 18 potential for restricted use on releasing metal. One option 19 being we could release -- or, I'm sorry, we could restrict 20- the first use of solid materials to some authorized use, 21 particularly, as it notes here, you could perhaps make steel 22 beams that you would use in a structural support.
23 We were at a meeting a couple of months ago where 24 a gentleman suggested we could make military equipment. He 25 was talking about tank treads, so, you know, rather than i
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i I 449 1 consumer products. So that can question can come up, or l () 2 3 that is a potentially valid alternative which we should consider. 1 4 A question that is associated with restricted use I l 5 would be that because of the uncertainties in controlling ) 6 material flow or where the material goes, we may need to ) 7 require that the processing of the material into this first ! 8 use be licensed by the NRC. So a question that is raised in i l 9 the issues paper is, should NRC license the -- I guess, the
- l 10 manufacturer, for example, of the bridge structure? And, l 11 so, that would be -- that is a question that is raised.
12 There are several questions that are raised in the' i 13 paper, I could run down what they are, related to that, 14 related to how long the restrictions should stay in place, i
'() 15 what are candidate materials. What is a good set up for .
16 restricted use? 1 17 An interesting question in the cleanup rule which 18 we just issued, there is a restricted -- there is some 1 19- parallelism, there is an unrestricted and restricted use of 20 _ buildings and lands in the cleanup rule, and if there is 21- restricted use, there is an opportunity for public ! 22 involvement in.how these restrictions are set up. In the 1 23 cleanup rule, if you restrict use of a building or lands, j 24 you terminate the NRC lfasnse because it was decided that 25 the public deed process of how a particular piece of land or l l { I jh' ANN RILEY & ASSOCIATES, LTD. . \ms/ Court Reporters 1 I 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
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450 1 building would be used can be satisfactorily covered by the 1 2 existing deed process, just the local land set up. i 3 So, the cleanup rule for the lands and structures ' i 4 allows NRC to terminate the NRC license when the dose level { l. 5 is reduced to a low enough level and then the whole process G of the restricted use, and the deeds and the lands only { l 7 being allowed to be used for, say, industrial purposes, not i 8' a farmer,.that is all an unlicensed use. Here, you may 9 have, because, like I say, there is no -- I don't know if 10 there is a deed process for tanks and pipes as they leave a 11 reactor, so you may have to license how this material is 12 handled until it winds up in a safe form. So that is the i 13 difference between the two rules. I 14 Also, the cleanup rule had a public involvement ; 1 l 1 15 process where how these lands were used could be reviewed by 16 .the local populace so they could provide input as to how 17 these lands and structures were used in a restricted way. 18 Here, because you have metal that will come out of the plant 19 and go anywhere in the country, having a public involvement l 20 process at a particular site maybe is different or may be 21 more difficult. So these are questions that are raised in 22 the issues paper. 23 The second alternative.that we list here is that 24 we would restrict release of the metal to only a landfill 25 site rather than allowing any consumer or industrial use at L r ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 o
451 1 I' The rationale for that would be that this would cut i 1 all. i l () 2 out any direct public usage exposure pathway and limit 3 exposure pathways to only what you might get from any [ 4 landfill exposure, which is generally thought to be at least 5 fairly well -- it can be fairly well defined, unlike perhaps L 6 consumer uses, which can be fairly broad. l l 7 So those are two restricted uses that we indicate 8 as potential alternatives. l 9 Finally with regard to the issues that we list, i 10 issue number four,~which is on page 13, the Commission l 11 directed us in their SRM. Their other point that they made
- 12 was that the rulemaking should cover all materials unless l
i' 13 there was some factor that would cause us to limit the l 14 number of materials covered, namely that it would delay -- () 15 if we expedite the rulemaking to limit the materials. covered 16 in the scope, we should do so. 17 Our technical basis that we have developed and 18 which Tony will get into a little bit is basically right now 19 limit it to metals, concrete, and to some-extent soil, sc 20 one alternative is to limit the rulemaking to a select group i l 21 of materials, namely metals, concrete and soil. Another 22' alternative is to apply it to a wider group of materials, as 23 you can see here, and another alternative would be to 24 conduct the rulemaking on this wider group of materials at a 25 later date and there are specific questions on that in the ANN RILEY &' ASSOCIATES, LTD. Cg Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 i
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n 452 1 issues paper. ! O[ T 2 The next page goes into the development of the 3 technical basis and I will let Tony proceed from here. 4' MR. HUFFERT: Thank you, Frank. I would like to l 5 point out some of the requirements that the Staff were given ; t ! 1 6 from tne Commission in its June 30th, 1998 SRM on how to 7 proceed with this rulemaking, j 8 They told us to develop a dose-based regulation as 9 compared to a detectability based regulation, so we have 10 ~been pursuing rulemaking at different dose levels, as Frank
'11 mentioned, from basically background up to 10 millirem with 12 values in between.
13 They asked us to focus on clearance levels above 14 background for unrestricted use, which means do not include () 15 background doses or background concentrations of 16 radionuclide in this rulemaking when you are doing your dose i l 17 assessment, and they also asked us to consider existing work 18 being conducted by the IAEA, other contractor analyses that 19 have been performed, for example the Environmental 20 Protection Agency has been working in this area.and has done 21 a substantial amount of work to date that we can draw upon. 12 2 ~ Also, speaking of EPA, we have been directed to 23 look into NORM and NARM practices. Specifically they asked 24 us to take a look at the practice to take coal ash and 25 recycle it into building materials. We think that that I l[~' ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
453
- l. I would be a. fairly interesting benchmark to consider when we 2 are developing'our own analysis.
l- 3 We have been asked to use realistic scenarios when 4 we are. developing the rule as compared to using really
.5 conservative analyses, and also'to consider the materials 6 that have been analyzed so far, which is iron, steel, 7 copper, aluminum, and to some extent soils.
8 On the next page I would like to talk briefly: 9' about.some of the work that has been conducted so far by the 10 Office of Research. They have been working for several 11 years with other Federal agencies developing a draft report, 12 NUREG-1640. This document covers iron, steel, aluminum, 13 copper, and concrete. 14 ~ The reason for these materials being selected was l- 15 that initial studies indicated that these materials would be 16 of economic value and that these would likely be released 17 from not only the NRC licensees but also DOE as well. 18 These materials have been studied by other Federal 19 agencies and we can draw upon that work also. 20 They took a look at 79 scenarios for clearance and 21 they specifically identified 85 nuclides to analyze, rne 85 1 22 nuclides were obtained from looking at manifests, Class A ' 23 waste, and then comparing that listing to work being done by 24 the Environmental Protection Agency. 25 DR. GARRICK: Are you going to say something about l ANN RILEY & ASSOCIATES, LTD. O- Court Reporters. 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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454 1 the basis of the scenarios? lm)
\J 2 MR. HUFFERT: I can, yes. Would you like for me l
3 to do that at this time? l 4 DR. GARRICK: Well, if you are going to later, 5 that's fine. I 6 MR. HUFFERT: Let me go to the next bullet and 7 then I'll talk about that. I 1 8 We are planning on issuing this draft NUREG-1640 9 this month. Currently there is a Federal Register notice 10 being developed by the Office of Research. We are hoping 11 that we will have a fairly long comment period on that 12 report so that it will extend well into the time that we 13 have our public meetings, which will be running through the i 14 Fall of this year. 7-( ) 15 About the scenarios, the 79 scenarios were arrived 16 at through trial and error basically. The Office of 17 Research looked at clearance, meaning there could be direct 18 disposal of material, there can be direct reuse of material, 19 and there also can be recycle of material. Recycle would 20 involve materials being released from a nuclear facility as 21' scrap. It would then be handled at a scrap facility where 22 it would then get back into a steel mill where it would then 23 be processed and then put back into use. 24 DR. GARRICK: And that is what you mean by a 25 scenario? I 1 [~'i ANN RILEY & ASSOCIATES, LTD. (_.) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 t
455 1 MR. HUFFERT: There are actually two different [L 2 models that were used to develop these scenarios. There's a 3 material flow model in NUREG-1640 which has different 4 scenarios of how this material is basically moving once it 5 is released and there is also a dose assessment model and 6 the dose assessment model has scenarios in there. These are 7 basically exposure scenarios so the combination of those, it 8 is my understanding, represents the 79. 9 As far as the limiting scenarios, it turns out 10 that consumer products are not the limiting exposure pathway 11 and in many cases it is truckdrivers or it is workers at 12 processing facilities. The workers at processing facilities 13 would be, for example, a worker in a steel mill where the 14 material can become airborne through different metallurgical [J L 15 processes and the material can be potentially concentrated 16 so these are the sensitive scenarios that have led to the 17 critical dose conversion factors. 18 Further work is needed to develop our technical 19 basis. NUREG-1640 really was focused on identifying 20 realistic critical groups and calculating dose factors for 21 each critical group. It did not get into collective dose 22 assessment. It did not get into soils. As Frank mentioned, 23 there has been some work done on soils for the 24 decommissioning rule, and we can benefit from some of that 25 work already done. But NUREG-1640 does not specifically l ()
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456 1 address soils. ['] v 2 We will have to develop more scenarios for the 3 noncritical individual dose scenarios that are needed for 4 estimating collective doses in population groups. We think 5 that we have to take a look at population behavior. We have l 6 to take a look at the probability of a number of persons 7 being exposed to both processing and the end products l 8 itself. NUREG-1640 does not cover that. So we are 9 currently in the state of we have developed a statement of 10 work. 11 We are going to go out for competitive bid to a 12 contractor to further refine that work. And we're also 13 going to be doing more work in the area of cost-benefit 14 analysis. The EPA has done work in this regard. However, (,,\ 15 the NRC has not.
%)
16 The third bullet on this page talks about some of 17 the progress made by the EPA in developing the technical 18 basis. In 1997 they released two reports. One was a draft 19 technical support document entitled " Evaluation of the i 20 Potential for Recycling Scrap Metals from Nuclear ! 21 Facilities." This is basically a data compilation report 22 that discusses supporting analysis for a second document i 23 they prepared which is called the preliminary cost-benefit 24 analysis and radiation protection standards for scrap metal. 25 The NRC Office of Research has been working closely with EPA ) ANN RILEY & ASSOCIATES, LTD. (s, C )T Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 t
e 457 1: on these documents and I think it's a very good resource for 2 us to use. [} ' 3' We will continue to develop our technical basis in 4 order to develop a generic environmental impact statement, a l i 5 regulatory analysis to analyze the different regulatory , 6. options, and, as Frank mentioned, we have four statements of ( 7 work that are being developed right now. ( 8 Two.of them have to do with implementation. .I'll 9 be. intimately involved with those, as I'll be working on a 10 -draft regulatory guide. We are planning on going to 11 national labs for that support. We will be focusing one 12 contract on survey methodology, and we'll be actually 13 focusing another contract on the detection of radioactivity, 14 the actual radiation physics involved, since we are going- ,() -15 down to'such low concentrations of radioactive material in 16 matrices -- 17 DR. GARRICK: Yes, at some point I'd like to hear 18* you comment a little bit about the problems that I can
'19 envision when you start talking about complying with the 20 one-millirem requirement, the-instability.that -- the 21 radiation instability that exists in some of these sites.
22' It' sounds like that's a tough challenge. 23 MR. HUFFERT: We faced a similar technical l 24 challenge when we were working on the decommissioning rule, i 25 'and'I was involved in that. We were given a task to go from t l. (~' ANN RILEY & ASSOCIATES, LTD.
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p 458 1 on the order of 30 millirem per year all the way down to () 2 3 basically background. the field. We contracted with some experts in We took a look at what was needed, and we 4 actually came up with new survey approaches that were ! 5 incorporated into MARSSIM. And that's been widely accepted. 6 I think that we're going to be facing a similar i 7 problem-here. The differences that the material that was L 8 analyzed for the decommissioning rule was basically on lands
'9 and structures, and in this case it's going to be 10 incorporated in metal. And detecting alpha and beta j 11- contamination when it's found in a matrix of steel is almost 12 impossible to do with the survey instruments. You might 13 have to use other methods, for example, taking samples in 14 order to do that.
() 15 Wc dot. t have any answers for you today. This is ! 16 under developmer.t. We started working on this in October, !
- 17 and we are currently in the stage.of getting our contractors ;
1 18 on board and lookir.g at this problem. I can tell you that i 19 the staff has been it:volved in recent workshops in this l 20 area. I've attended a couple of them where this was L 21 discussed. And there is a lot of work going on both 22- nationally and internationally in this area that we can draw l 23 upon. l 24 MR. CARDILE: Also I think the two contractors 25 that you're planning on using are the ones that assisted you
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1 459 1 on the -- g ( ) 2 MR. HUFFERT: Yes. Well, we're hoping for that. 3 MR. CARDILE: Okay. 4 MR. HUFFERT: We're in the stages right now of 5 trying to get contractors on board, and the one in 6 particular is extremely good at radiation physics, and I 7 think they would be invaluable to have on board, because 8 they could help us in that area. 9 The next slide was put together to present a 10 snapshot of where we are today in our technical basis 11 development and the work ahead of us in order to complete 12 this rulemaking. On the left-hand side of the table we have 13 basically the NEPA analysis, which is referring to"our 14 generic environmental impact statement that we'll be p) (, 15 developing, the regulatory analysis, the draft reg guide, 16 and then public participation. The middle column discusses 17 the regulatory requirements or procedures that we would be 18 following in the development of our technical basis. For 19 example, under NEPA, we have fairly clear guidance on how we 20 should proceed in our own 10 CFR Part 51, 21 Under the regulatory analysis, as Frank mentioned 22 before, we have Executive Order 12866, an SRM, and also a 23 brochure report on how to conduct that. We just talked 24 about the draft regulatory guide, how we need to develop 2.5 practicable instrumentation methods, and as far as the ANN RILEY & ASSOCIATES, LTD. [\ - Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
460 1 .public participation, we would be holding four publ,c ( ) 2 meetings during.this year throughout the country, and that 3 will be satisfying two'requirerents. It's not only going to 4 be ',itisfying the 10 CFR 51 process but it will also be 7 5 satisfying our own enhanced participatory rulemaking 6 process. 7 To the right we have the technical information 8- needed, and to give you a feeling of where we are today, we 9 have items A through L listed. We only have item A and item j -10 K at this-point. Item A is NUREG-1640, which talks about l 11- the' individual dose factors for four materials. We need to l 12 develop items B through G in order to do our EIS. Items H 13 and I are more involved in the costs. We need to find out 14 more information on the actual source inventory. That has
'( I 15 not been well defined. We need to find out economic impacts l 16- that will be given to industry with this rulemaking.
17 And as far as the issues papers is concerned we're 18 getting that out for public. comment next month, and I i 19 already discussed the public workshops. 20 It's also important for you to understand what the 21 staff is involved in amongst other Federal agencies. I 22 alluded to work with the EPA, but we're also norking with L
- 23. the; Department of Energy and other Federal agencies on the "24 Interagency Steering Committee on Radiatiun Standards.
25 We.recently had a subcommittee meeting in February ANN RILEy & ASSOCIATES, LTD. Os Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
(~ 461 1 where we talked about our.rulemaking efforts and other work () 2 3 that's being done in'the Federal Government in this area. There is a Department of State initiative called the 1 4 International Radioactive Source Management Initiative. It 5 is something that is fairly recent in its development. We 6 have many different Federal agencies participating on that 7 initiative, private industry, we have the Conference of 8 Radiation Program Control Directors, and the focus is not i i 9 only on clearance, but it's on source tracking 10 inturnationally. 11 The NMSS and research staff have also been
.12 participating internationn.lly with meetings at the IAEA, and 13 we have one group of people going from the EPA, NRC, and DOE 14 over to Vienna next month to work on one of the technical
() 15 basis documents called Tech Doc 855. So the staff is quite 16 busy in this area. 17 That concludes my presentation. l 18 DR. GARRICK: Further comments? 19 DR. WYMER: Yes. I am glad to see you working on l l 20 this. I think it is an extremely important issue and I 21 think there are hundreds of millions of dollars at stake 22 here, depending on how this thing comes out. I had one 23 specific question. It seems to me, I am sure you have good 24 reasons, that you are limiting yourself quite a bit when you 25 talk only about ferrous metals, aluminum, copper and i ANN RILEY & ASSOCIATES, LTD. O,__ - Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L
r 1 462 1 concrete. I suggest that maybe you might want to consider 2 the strategic and. critical materials list that the 3 Department of. Commerce puts out, since these are strategic t 4 and critical materials, and they have a definite definition 5 of what thase terms mean. 6 So-it seems to me that this rule will be applied 7 broadly eventually. No matter how you initially decide you 8 are going _to direct it, it will be applied as broadly as 9 people choose to apply it. So I have that one comment 10 specifically. 11 MR. CARDILE: Yeah, I think -- and that is one of 12 the questions in the issues paper. It lays out the material 13 or the equipment and material we have information about now, 14 the database we have now, and then it requests, well, what () 15 other suggestions are there for materials? And we would 16 certainly take that under advisement. 19 DR. WYMER: Any other comments? 18 DR. HORNBERGER: Yes. Can you give me an idea -- 19 you say are going to develop a dose based regulation , 20 considering from background up to 10 millirem. Why 10? Why l 21 not 100? 22 MR. CARDILE: I will start and then you can jump 23 in. 1 24 MR. HUFFERT: Sure. 25 MR. CARDILE: Well, it lays those I guess three or ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 463 i 1 1 1 four as what we think are probably potential alternatives. 2 The opening paper, for the cleanup rule, s'arted at 100 and (} 3 suggested 100, 25, you know, 15, 10, 1 down to background, 4 and we wound up having a dese standard of 25 millirem for 5 the cleanup rule for a land and structure based on, to some 6 extent, on the fraction of 100 millirem as the appropriate 7 value. l 8 The initial thought in preparing this paper is 9 that, because, potentially, these materials can be more 10 dispersed in the public usage than perhaps one fixed 11 decommissioning site, or decommissioned site, that a value 12 less than the 25 millirem from the cleanup rule was probably 13 more appropriate here. 14 Numbers that have been, you know, used or talked r (x j) 15 about in international circles, for example, for clearance, 16 have been the range of 1 to 3 millirem, so at least as an j l 17 opening suggestion here, we listed 10. Again, the question 18 in the issues paper, are these appropriate values or not? 19 DR. HORNBERGER: So sort of your rationale is that l i 20 because these would be sources that could move around, that ' 21 they would somehow be potentially more dangerous than a 22 source that was fixed? 23 MR. CARDILE: Well, not more dangerous, but 24 perhaps a person could be exposed, whereas, a person would 25 not likely be exposed -- well, not more likely. The dose l rFs ANN RILEY & ASSOCIATES, LTD. (_ l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034
p I 464 1 ' calculation coming.up with the 25 millirem for a I) 2 decommissioned site is a person, a resident farmer or a
\~)
3 resident person living or working at that site. That is
'4 kind of the limit as to what they would get. Whereas, here, 5 it is not that it is more dangerous, but there is potential 6 for, I guess, more multiple exposures in that --
7 DR, HORNBERGER: So it is'a collective dose 8 argument rather than an individual dose? 9 MR, CARDILE: Well, it is also'an individual dose 10 argument to an.incividual, if we have to watch that you 11 don't get more than this dose level from a particular -- 12 that you can't get exposed to several pieces of equipment, 13 or former pieces of equipment -- 14 DR. HORNBERGER: If steel goes into a car and you
) 15 drive around a car for your life, and that is worse than 1 16 being a farmer living at the site? j t
17 MR. CARDILE: No , but the steel could go into the i 18 car, and, you know, the material building your house, and 19 the material, you know, in your car, your bed frame or 20 whatever, things like that. 21 DR. HORNBERGER: Has anyone worked out the 22 probabilities that those multiple things would happen? 23 MR. HUFFERT: Actually, that is one of the things 24 that is going-to be looked at in our statement of work for 25 the continuation of the NUREG-1640 work. We are looking at O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 t.
465 1 exposures to multiple sources and population behaviors. () 2 3 That has not been done so far, and it is '.)ing to be a large piece of wtrk to get that accomplished. 4 D t. GARRICK: Have you done the cost -- 5 implementat.'on cost studies as a function of different i standards, different clearances? I 6 ( 7 MR. HUFFERT: We will be working on that. How we l 8 did it for the decommissioning rule was we chose different 9 dose levels and we then took~the dose levels, converted it 10 to picocuries per gram by using a dose conversion factor, 11 and once we had these levels of radioactive contamination 12 present, we then did studies to figure out what is the cost 13 of surveying to different dose levels. We would just take 14 different concentration values. We set up studies where we (A) 15 would use very crude instrumentation, all the way to 16 extremely sophisticated methods that are almost 17 impracticable to use to try to figure out where the state of 18 the art was. 19 And from there, we basically came up with cost 20 curves, and we could see where certain radionuclides were l 21 very difficult to measure and it helped us in our generic 22 Environmental Impact Statement. And a similar thing would 23 be done here for this rulemaking. The statement of work 24 that I have been working on with the Office of Research has 25 that stipulated, that we would go from a return to ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i l 466 1 background or background level, all the way up to 10
;f 2 millirem or more. We think we have a handle on what the t
3 dose conversion factors are from NUREG-1640 and other work 4 done by the federal agencies, so we can start applying that 5 work -- I'm sorry, those dose conversion factors to our 6 study. 7 DR. GARRICK: What about pilot applications as a 8 rule, is this planned? 9 MR. HUFFERT: As far as implementation? 10 DR. GARRICK: Yes. 11 MR. HUFFERT: That is in the statement of work. 12 DR. GARRICK: Yes. 13 MR. HUFFERT: Not to sound like a broken record 14 here, but when we did this work for the decommissioning (% 15 (
) rule, we did pilot studies at large decommissioning sites.
16 We also set up a maze, if you want to call it, at one of the 17 national labs, work surveyors were required to go in and 18 survey against walls to find out how well they could detect 19 different radioactivity levels, and thut also helped us as a 20 pilot to understand what -- how implementable our rule l t 21 really was. And we are planning something similar to r? ir 22 here. l 23 DR. GARRICK: What have been the operators' 24 reactions to the program you have made so far, the people i 25 that have the facilities? l l 1 1
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I I 467 l 1 MR. HUFFERT: I haven't talked to anyone yet about [ 2 that. I have talked to people in the Office of Nuclear 3 Reactor Regulation about it, since they are the group 4 regulating the reactors and they are on the working group, 5 they are on the steering group, they haven't raised any 6 concerns yet. 7 We don't know where the dose standard is yet, it l l 8 is an open book right now. If it is a higher level, it I i l 9 probably will not present a problem. If it is much lower, i f 10 it would be more difficult to implement. l 11 DR. WYMER: How much attention are you paying to 12 the international standards in this area? They have already 1 13 gone through this, at least some of the countries, and they l 14 have established standards, and they have methodologies o Q 15 established. How much are you taking that into account? 16 MR. HUFFERT: The Office of Research -- in fact 17 the technical manager for NUREG-1640 is a member of the 18 working group who's developing Tech Doc 855. He'll be going I 19 there next month to refine that document further. He has 20 been a very good resource for the agency, and we are kept 21 aware of what's going on through him, and also our Office of 22 International Programs. 23 As far as implementation is concerned, I can talk I j 24 to that a little bit, if that would help. There are studies i 25 going on internationally in this area not specifically
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i l i 468 1- related to clearance, but illicit trafficking, and for l l l () 2 3 example there's a study _being conducted right now at the IAEA that is - _they have set up a portable monitor at one I l 4 of the -- I think at the Austrian borders. They are I l 5 evaluating instruments from France, Germany, the United l 6 States, England, I think Sweden. They're evaluating the 7 ability of these equipments to detect radioactivity in scrap I 8 or some type of' confined geometry. There will be a workshop 9 .next month at Los Alamos on this, and I can tell you I just 10 recently participated in a workshop with the steel industry i
'll on detection of radioactivity in scrap which will actually J l 12 .be very close linked to what we're doing here.
i
- 13. DR. WYMER: Fine. Thanks.
14 DR. GARRICK: I take it that this is a status (Oj 15 report, that you're not looking for anything specifically 16 from us except the discussion. l 17 MR. CARDILE: That's right, and as I pointed out, l l 18 a good time to -- we'd be interested in -- the point of the 19 issues paper and the public meeting is to get feedback to l l 20 feed.into some of'these contracts as we go forward. And ! 21 we'll be reporting back to the Commission in hopefully l l .22 February of next year based on the results of all of these 23 public meetings. So a good time to get some strong feedback j i 24' would be'in amongst the public meetings that we're holding 25 in the fall, either while we -- or, you know, during that ANN RILEY & ASSOCIATES, LTD. ) O- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I 4
l l 469
- 1. period of time or maybe immediately after that time .4e'll
./ '2 probably be in a position to report back some preliminary 3 resultsLabout the meetings and also-receive your input.
4 DR. GARRICK: I guess that the real key here is 5 that net as what you end up with.is the actual clearance l 6 limits, clearance level. Is that right? And so the process 7- by which you get'to those levels. And you say that those 8 have not really been established yet. , i 9 MR. CARDILE: The clearance levels? 10 DR. GARRICK: Yes. 11 MR. HUFFERT: No, not at all. 12 MR. CARDILE: Well, I'm sorry, yes, the process 13 for us doing this rulemaking has been laid out, and it's 14 laid out in management directives, . our regulations, et (Oj 15 cetera. But as far as what the actual value is going to be, 16 no, we don't have -- we don't know if it's going to be 10 or 17 100 millirem or zero. 18 DR. GARRICK: Now are you satisfied that the way 19 you're proceeding that everybody that has involvement in i 20 'this process, the stakeholders, the public, et cetera, are 21 in a position to contribute information for you to make -- 22 -for that decision to be made? 23- I'm always thinking a little bit about the smaller 24 operators who don't always have the resources to handle 25 these kind of projects.
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- 470 1 MR. HUFFERT
- I can tell you that when we do an 2 analysis we're' required in our regulations to look at the s
l- 3 economic impact of a proposed rule on small entities under l-4 the Regulatory Flexibility Act, we need to do-that.
~5 DR. GARRICK: Um-hum.
6 MR. HUFFERT: And as Frank had mentioned, we are 7 actively-involved with the States in our working group and 8 steering group, and certainly the public meetings, the j 9' Federal Register notices, we're going to have a Web site set
- 10. up'for comments on this. We'ro asking for a lot of public j 11 participation.
12 MR. CARDILE: I expect that one of the l 13 ' participants in the public meetings will be, for example,
- 14 the scrap dealers or the steel manufacturers, and they'll
( 15 come back to us with a lot of information about what's 16 practical and not practical, what impact this could have on 17 their industry and not. 18 With regard to -- that will represent both the 19 large and small people who will be receiving this material, j 20 In terms of the large and small NRC licensees, that'll be -- 21 I presume that'll be part of what we're getting at with some 22 of these contracts that you do on survey abilities and 23 capabilities and what are the costs to survey material, 24 whether it's a reactor licensee or a small hospital. So -- 25 DR. GARRICK: What do you consider to be the most O ANN RILEY & ASSOCIATES, LTD.
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471 1 difficult technical issue? Is it the surveying part of the t-
- i. 2 problem?. When you're dealing with these low levels?
f 3 MR. HUFFERT: I think it's going to be a 1 l 4 tremendous technical challenge if we are required to go to 5 zero. 6 [ Laughter.] i 7 I don't mean to be facetious, but if you're at 10 8 millirem per_ year, it's a much easier target, but if you're 9 at a small fraction of 1, it could be very difficult now. 10 Maybe we can come up with some innovative methods of 11' surveying. I don't know yet. 12 DR. WYMER: In inferred, perhaps wrongly, from 13 something that was said, that maybe you'll be making these 14 permissible doses on these various kinds of materials D d 15 radioisotope-specific with respect to the contaminant, and 16 in particular with respect to the half-life of the l 17 contaminant, since obviously if it's a short half-life, it's 18 not so important that it have a low a dose, because after a 19 little while you won't have so much. 20 Is that in there, or did I read something more 21' into it than you said? 22- MR. HUFFERT: Go ahead. 23 MR. CARDILE: I'm going to let you answer. I was ; 24 just going to say one point I may have made which may have 25 been. confusing was that, for example, a restricted use might l l ANN RILEY & ASSOCIATES, LTD. O) ( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034.
472 ; I 1 be something that's beneficial where a half-life -- an I ( 2 isotope had a short half-life because obviously it goes 3 away. I 4 I don't think we're planning on setting a dose 5 limit based on -- 6 DR. WYMER: On specific -- 7 MR. CARDILE: Specific isotope. l 8 DR. FAIRHURST: How will you know where to look ! 9 for this? I mean, there's certain pathways you can follow, 10 you know, where something started out, but you're talking l 11 about scrap yards and things like this. How would you -- 12 were you going to have a blanket requirement on all scrap 13 dealers that they must check? Or am I -- 14 MR. CARDILE: Are you talking about in general or f- 1. about this restricted use possibility? 16 MR. HUFFERT: The surveys would be conducted at 17 the point of release of the nuclear facility. 18 DR. FAIRHURST: Okay. 19 MR. HUFFERT: I think before the material was 20 released from the nuclear facility, you'd have to survey it, 21 assay it, whatever, before it gets out -- 22 DR. FAIRHURST: All right. 23 MR. HUFFERT: To the general public. 24 MR. CARDILE: But once it was released -- once it 25 was surveyed at that point and released for unrestricted i
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473 ) 1 use -- () 2 3 DR. FAIRHURST:
-MR. CARDILE:
Then you don't worry about it. It can go anywhere, and the hope is l 4 that these dose models that have been done in NUREG-1640 5 would sufficiently represent these pathways. 6 DR. FAIRHURST: There's no need for concern? 7 MR. CARDILE: Yes. ! 8 DR. FAIRHURST: I don't -- i 9 MR. CARDILE: And that's why the restricted use is 10 in -- because it.says that while_if it's decided that -- to 11 limit where this material can go, then you have questions of j 12 well, how do you do that? And it's something we'll have to 13 face. 14 DR. FAIRHURST: Is this an issue that when you're () 15 talking abcut pub 3 ie meetings that there will be a broad 16 spectrum of public involved or just people who feel like 17 have some sort of business or -- a business reason for -- 18 MR. CARDILE: Well, I think, as I was saying, 19 there would be the nuclear industry or the licensed 20 industry, not just sometimes when we talk about nuclear we 21' think about, you know, power reactors, but it would be the 22 whole licensed community. I mean, people from small walks 23 'of life with regard to licensees. 24 lit would also ba the people who-then receive the 25 material, they have a business interest, but they also have l-t
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1 474 1 a from what we've heard somewhat they also have an interest ()
- \._/
2 in terms of we're a steel manufacturer or where a scrap 3 dealer, and we either can or can't deal with this material. 4 So there would be that spectrum of people. 5 But then there would also be -- and I think that's 6 the process of the facilitator is to go get other, you know, 7 public groups to say we're concerned or not concerned about 8 this material coming into general commerce or general public 9 consumer use, and if it does, what are the dose levels and 10 that type of thing. So the hope is that the facilitator 11 sets up these meetings so we get kind of people along this I 12 step of this process of where this material could wind up. 13 MR. LARSON: Is your question in some of the past 14 participator.y rulemakings, you xnow, the agency has provided () 15 funds to some people that are unable to get to the thing 16 otherwise. Are there plans in this one to do that? 17 Is that what you're asking, Charlie? Like the 18 Native Americans -- 19 DR. FAIRHURST: What I'm trying to say well, if 20 you have to go down to one millirem, or .1, it would seem to 21 me that you're going to have a lot of pressure in any public 0 22 meeting to keep going lower and lower and lower, and at some L 23 point you have to say look, this doesn't make either risk ~ 24 sense or financial sense or whatever. I don't know. I 25 just -- l.
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475 1 , MR. CARDILE: Well, one of the things that -- l [ 2 well, one of the things that the issues paper points out 3 that the public meetings are intended to foster discussion, 4 obtain advice, obtain' data or information, perhaps not to 5 reach -- and point out things like competing impacts, point i 6 out things like implementation problems like going to zero, j 7 but not necessarily to reac'1 consensus. So -- 8 MR. HUFFERT: That analysis will be performed in i 9 our generic environmental impact statement and regulatory. 10 analysis. There's a process set _up for weighing the , 11 different factors. I 12 MR. LARSON: If a clearance level is for l 13 unrestricted use, then why are you going to go through a ! 14 collective dose analysis, which sort of amplifies the l () 15 situation that -- I don't understand. 16 MR. CARDILE: I can start. Again, for example, 17 these cleanup rules, for example, we went through a process i 18 of saying all right, well here's the exposure to an ! 19 individual, but, you know, on the other hand, especially in 20 the case of clearance, you might, while the exposure to an 21 individual may be low, the exposure to a large number of 22 people because there's a lot of equipment available could be 23 higher'. l 24- The guidelines of NUREG or BRO-058 in complying 25 with the cost-benefit regulatory analysis guidelines talk Q
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1 l 476 1 about balancing costs and impacts. So we'll be looking at l [v ') 2 both individual dose and collective doses. 3 Di . GARRICK: That likely introduces -- doesn't ! 4 that introduce a real complication as far as accountability 5 is concerned? l 6 MR. HUFFERT: What do you mean by accountability? 1 7 Do you mean as far as defining the population? l 8 DR. GARRICK: Yes.
]
I 9 MR. HUFFERT: Yes. I think that what would happen i 10 is we would have to give it our best shot of not only l 11 understanding population behavior, but also try to estimate 12 the uncertainty in those numbers. And when we are 13 collective doses, I think we should be checking the 14 uncertainty in those numbers carefully. And if we follow 15 NCRP 121 we would be categorizing our uncertainty estimates 16 for the collective dose. 17 MR. CARDILE: An additional uncertainty in trying 18 to estimate collective doses is, if you are just calculating ; 1 19 individual dose, you just need to know if such-and-such 20 concentration gives you such-and-such individual doce. In 21 orr.er to calculate collective dose, we have to go back and 22 make some estimate ha what is the volume of metal at a power 23 plant available at these levels. And that is something that 24 is going to be part of these contracts, but it is not easy l l 25 to put a handle on. l 1 i l [ 5- ANN RILEY & ASSOCIATES, LTD. 'N_- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 (202) 842-0034
l. L 477 1 DR. GARRICK: It sounds like a nightmare to me.
.( ) 2 -Doesn't this run the-potential of forcing you into the i 3 equivalent on an individual dose that is --
l l 4 DR. HORNBERGER: Minuscule. 5 DR. GARRICK: -- minuscule and infinitesimally ) l l 6 small? Isn't there an allocation problem here of great ! 7 proportion? 2 l 8 MR. CARDILE: Well, an experience we had in -- I l 9 keep referring to the cleanup rule, but an experience we had 10 in the cleanup rule was that we tried to do the same thing. 11 We looked at, what is the collective dose from people either 12 coming on and using these structures or lands for different l 13: possible uses down the road? That was a little easier 14 because'there is perhaps a limited number of ways you can , () 15 use a. building. But we actually looked at the building and 16 said, all right, this building could be used for a certain 17 type of usage, and the lands, or it could be used for an . 18 apartment building, you know, where there is a lot of l 19 people, but a lower dose because you only -- you know, there 20 is a limited number -- a limited amount of usage of the 21 land, as compared to, say, a resident farmer who is growing 22 the crops. 23 So we tried to look at alternate collective doses, j 24 and we had several different alternatives. And what we -- 25 .if you go back'to the statement of considerations for the ! ( ANN RILEY & ASSOCIATES, LTD. Court. Reporters ! 1025 Conn'ecticut Avenue,'NW, Suite 1014 ! Washington, D.C. 20036 (202) 842-0034
r. 478 y 1 final' cleanup rule or decommissioning rule, we, in essence, 2' ( said that, look,' there is not an absolute -- I forget the
~
a 3 word we used, but there is.not an absolute, definitive l l 4 answer with' regard to where the best ALARA: number or the 3 best cost benefit number'is. It can vary, you know, based 6 on the circumstance, based on uncertainty. 7 The cleanup rule wound up saying we think that 25 ! 8 millirem is the right' fraction of 100 millirem. We think 9- that this is sufficiently supported by the regulatory an and 10 collective dose' analysis that we think this is the 11 appropriate number. So that is a long way around answering 12 your question that, you know,, in that case, we basically 13 looked at the individual dose and said we think this is the 14 appropriate number. We looked at the regulatory analysis
'( I 15 and balancing of collective doses and benefits, or costs and 16 that said that, you know, we can't make the decision based 17 on that.
18 We think we are right here with the right number.
~
19 The same thing could happen here. We could decide upon an 20 individual dose that we think is an appropriate constraint 21 4 below 100 millirem, an appropriate fraction of 100 millirem. ; 22- : We could look-at the collective -- we could say that 23 implementation-wise, you know, you can measure this in a 1 24 - reasonable way. And with regard to the collective dose, i 25 - given.all the uncertainties of quantity of metal, following ' () ANN RILEY & ASSOCIATES, LTD. (_s/ Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
o 479 l l 1- people around, how they might use this material, that, you 2L know,.that we think whatever this individual dose value we V("h 3 have set is reasonable. So that's two years ahead of where 4 we are right now, but --
- 5. DR. GARRICK: It seems that we work very hard to
.6 make this as complicated as it can be.
7 MR. CARDILE: Well, of course, we are required, as 8 Tony's slide points out, to do a NEPA analysis, to do a 9 regulatory analysis using the guidelines of the NUREGs. 10 MS. THOMAS: Wait, wait. If you are not going to 11 account for the material once it gets released for 12 unrestricted use, how are you going to determine collective-13 dose? That just doesn't -- it doesn't follow. 14 MR. CARDILE: Well, we are going --
./'T 15 MR. GNUGNOLI:
() I think you have it just backwards. 16 What we have to do is decide what criterion we will use. In 17 order to see the cost benefit of using the different 18 criteria to set clearance, we have to sort of know what the 19 cost is going to be, both in terms of health effects and in 20 terms of the commercial impacts and such. And, so, sort of 21 the other way.in that. Once we have set the clearance 22 criterion and everybody accepts it, who cares what happens 23 with all that? 24 You know, ut this point we are taking the lead 25 from other organizations who have gone a little bit ahead of fgI ANN RILEY &. ASSOCIATES, LTD.
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g i 480 1 us , like IAEA, where they have tied it traditionally to the jT 2 idea of trivial dose, which is the 1 to 10 millirem range V 3- from Safety Series 89. And that is basically why it 4' factored into our range of numbers that we selected for the 5 dose considerations. 6 And then other people will say the difference 7 between 10 millirem and 30 millirem is really 8 inconsequential. So the idea is perhaps in that range, we ; 9 will cover enough that it might be below, let's say, the D l l 10 and D standard of 25, that we have, in effect, tried to I 11 cover the spectrum a little bit at the lower end. 12 DR. GARRICK: So given what we have heard from the 13 health physics experts about the effectiveness of 100 14 millirem standard as assuring the. protection of the public, () 15 given that kind of information, what is your view with 16 respect to risk and safety if we eliminated the collective . 17 dose requirement in the rule? 18 MR. CARDILE: We are not anticipating having a l 19 collective dose requirement in the rule, of course. I mean 20 we are only using it as a tool. The rule would b, -- 21 DR. GARRICK: Well, to calculate the dose. Yes. l j 22 DR. FAIRHURST: What is the basis for the IAEA 1 l j 23 'to 10 as being trivial, is that -- t l 24 MR. GNUGNOLI: It is out of Safety Series 89. j 25. They went into it to some degree -- there is a discussion in l l-Q (j ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
481 1 Safety Series 89 on setting that. [') 2 DR. FAIRHURST: No , but I mean was that based on %.J 2 sort of idea that a collective dose, no matter whatever 4 material it was, you could never do any harm with 10 5 millirem? 6 MR. GNUGNOLI: I really don't remember. 7 DR. FAIRHURST: Or did you just pluck it out of 8 the air? 9 MR. GNUGNOLI: Actually, it would have been a 10 number of experts plucking it out of the air, that's the way 11 they work. 12 DR. FAIRHURST: I think most people would agree 13 that 10 is trivial. 14 MR. GNUGNOLI: Right. / \ ( ,) 15 DR. FAIRHURST: That doesn't mean that 10 is a j i 16 justifiable number, 17 MR. GNUGNOLI: Well, the idea -- I don't doubt 18 that there are practices and activities with higher possible 19 dose levels that would be okay. The idea over this 20 triviality aspect is it would be applied across the board to 21 any activities so you wouldn't have to think about it. 22 DR. FAIRHURST: Right. I understand. 23 MR. GNUGNOLI: But in things above those levels, 24 it may still be perfectly safe, but they would have to be 25 looked ac site-specifically. T ANN RILEY & ASSOCIATES, LTD. [~'/ i, ss Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
1 482
'l DR. FAIRHURST: It-is like shooting yourself in 2' the' foot.
3' LMR. GNUGNOLI: Yes. 4 DR. GARRICK: One of the things that I think that 5- .is a hopeful advantage of a' risk-informed approach to 6 regulatory practice is simplification, is, you know, the 7 idea of getting away from subsystems requirements over 8 prescriptive, intermediate results, et cetera. So that is 9 an aspect that we are looking for. 10 One of the things I was curious-about here is,
-11 ~given that you have guidance from the commission level with 12 _ respect to regulations and the development of new 13- ' regulations to adopt a' risk-informed, performance-based 14 perspective, what have you done here to do that? As best I
() 15 can tell, the only thing you have done is the so-called
~16 probabilistic exposure scenarios. Is that it?
17 MR. CARDILE: I guess -- don't forget, we are at 18 the very early stages. 19 DR. GARRICK: Yes. 20- MR. CARDILE: As Tony mentioned, we are planning 21 on making sure that this thing is implementable, any dose 22 level we pick is implementable. The other thing is we are 23 looking at what is the appropriate individual dose level, 24 what is the appropriate risk that we are looking at here. ! 25_ -So, I think, you know, obviously, this rule is going to be O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025-Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
483 1 based on both the risk to an individual and the ability --
;g) v 2 the capability to implement whatever rulemaking we come up 3 with.
4 DR. WYMER: I have a -- l 5 MR. CARDILE: But we may be -- I'm sorry, I didn't 6 mean to cut you off. I I 7 DR. WYMER: Go ahead. 8 MR. CARDILE: I was just going to say that that is j l 9 the idea, the point of the issues paper is to say, is this ' 10 the appropriate set of factors to be using in the 11 consideration of setting the standard? l 12 DR. GARRICK: Yes. I 13 MR. CARDILE: I mean here is alternative dose 14 standards which we could use, here are some of the factors
/%
( ,) 15 that we would consider in developing them, namely, health 16 and environmental impacts, cost benefit implementation, 17 other countries' standards. What guidelines would you give, 18 you know, the collective you, as we proceed? 19 The point of the issues paper is to foster this 20 kind of discussion, but we don't have the answers to these 21 questions We're trying to formulate what our questions 22 that we can go to the public with and -- both the general 23 public and the regulated public and the steel manufacturer 24 public would, you know, wherever they fit in the spectrum i 25 and talk about these kinds of questions. l ss ( ANN RILEY & ASSOCIATES, LTD. k-- Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 I
484 1 DR. GARRICK: Yes. Well, we sort of believe, I [) 2 think, as a committee, that the strategy with respect to ! v 3 regulatory development, if indeed you're going to go in the 1 4 direction of risk-informed performance-based, is to make 5 them very tough with respect to performance and riek 6 requirements, but &llow a lot of flexibility with respect to 7 how you get there, and move away from overprescriptiveness 8 of the intermediate steps. And I take it that's what you're 9 trying to do with a dose-based approach. l 10 MR. CARDILE: Definitely. I think, for example, 11 if you go back to the cleanup rule, it's fairly 12 unprescriptive in the sense that it lists a dose standard. 13 DR. GARRICK: Right. 14 MR. CARDILE: And that's basically it. i
/~N i (s- ) 15 DR. GARRICK: But I'm a little worried about this i
{ 16 issue of what you end up with as dose levels, number 1, and 17 how that is allocated, number 2. l 18 MR. LARSON: Are you alluding then that you'd like 19 to see the issues paper and the technical basis document 20 rather than towards October and November, sooner than that? l
\
g 21 Because supposedly a technical basis doc can be out -- ; 22 . you're saying June, right? And of course the SECY says the 23 issues paper was out in January, but it still hasn't got out ! l 24 yet. l 25 MR. CARDILE: No, the issues paper said that it l i i Q l (' (/
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485 1 would be sent to the Commission in March, and that's what l (} 2 we're planning on doing, and then we will publish it in 3 April for comment until November. The NUREG-1640 is 4 scheduled for publication in March. 5 DR. WYMER: Yes, that sort of gets at what is the i 6 extent of the responsibility of the Nuclear Regulatory ' 7 Commission in these kinds of matters. In a way it gets at 8 that. It also relates in a way to two points I raised 9 earlier on strategic and critical materials and whether or 10 not you're radioisotope-specific in this thing. 11 Although I kind of inverted the last one now, and i 12 I'll say what materials are you going to pay particular i 13 attention to, if any, and let me tell you what I mean when I 14 ask that. I'll give you a trivial example, but there f% ( ) 15 probably are better examples. 16 I know, for example, that there was a great deal 17 of concern in the people doing very-low-level background 18 counting that we don't crud up the copper that's used in the 19 instrumentation, and there are probably other similar 20 examples that can be found in specialty uses of materials 21 that might be contaminated with low levels of radioactivity
- 22 that would be deleterious to scientific investigations or 23 health studies or things like this.
24 So are you going to try to pick out, you probably l 25 are not, but pick out specific materials that have known I (3 ANN itILEY & ASSOCIATES, LTD.
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r= 486 1 specific sensitive uses, uses that are sensitive to
- l (~
V).- 2 radioactive contamination and put them into a special class 3 with special requirements? 4- MR. HUFFERT: No , not to my knowledge. 5 DR. WYMER: The answer is no, huh? 6, MR. HUFFERT: So far what we're doing -- 7~ DR. GARRICK: Simple answer to a long question.
- 8 DR. WYMER: Yes.
9 MR. HUFFERT: We are focusing on copper, aluminum, i 10 iron, concrete. That's what was done. We will be including 11 soils at the Commission direction. And for this proposed l 12 rulemaking, I don't think we're going to be including any more materials unless we're directed otherwise. 1 13 It's one of ! l 14 the issues that are contained in.the issues paper, should we j () 15 be doing this. So -- 16 DR. WYMER: Copper of course is one of the -- 17 MR. HUFFERT: Right. . 18 DR. WYMER: Sensitive materials. l 19 DR. GARRICK: I guess one of the things that would 20' help the committee & great deal on this whole issue is to l l 21 get a better sense of the world into which this thing is 22 going to be applied, because it would be easier for us to 23 . visualize what kind.of problems might develop if we better 24 understood the variety and spectrum of applications in the
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487 3 1 shape, et cetera. 2 I'm'sureiwe can. dig that out, but I think that 3 it's important-to understand the operational implications Ai when you're~looking at any kind of future development.of
- 5. regulations.
6 That's why we ask the questions aboub. 7 participation, who participated in developing source 8 material that you use to move forward with the 9 documentation. 10 I don't know whether it's practical for us to at ' 11 'some point in time get a little better overview of how1this L 12 thing is-going to be used or not, Howard. 13 DR. GARRICK: I think -- part of my concern about 14 a lot of'these things is I think we sometimes -- the j 15 conmittees are handicapped unless they're really 16 operationally involved and can get overacademic about their 17 consideration of some of these= things, and I think we need l 18 to be a little educated on the field and what's going on out 19 .there in order'to better visualize some of the problems that 20 you might run into. 21 I don't know if that makes any sense to any of my
- 22. colleagues or not.
- 23. DR' WYMER:
. I don't mind being called academic.
l 24 DR. HORNBERGER: Howard can brief us. 12 5 MR. GNUGNOLI: One of the things that really ANN-RILEY-& ASSOCIATES, LTD. O- Court Reporters 1025. Connecticut Avenue, NW, Suite 1014
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-g 488 1
1 wasn't discussed a whole lot is the fact that the United t l [) U 2 States may be faced in the future with itaportation of i 3 materials, and there's very close work with the State 4 Department on that. There's -- we are aware that perhaps 5 the extent that you are addressing can be described as 6 pervasive. It's almost in every -- 7 DR. GARRICK: Yes. l 8 MR. GNUGNOLI: You know, aspect of our society, 9 and maybe we're putting too much stock in this enhanced 10 participatory rulemaking process. But it is our hope that 11 we will glean more and more of a picture as time goes on 12 with people telling us you don't have the idea of what's 13 going on, what about this and thic and this? 14 DR. GARRICK: Yes, one of the bodies that I like
,~.
( 15 to hear from of course Tre the people that are going to be 16 affected by this. 17 MR. GNUGNOLI: Did you say infected? 18 DR. GARRICK: Affected, and particularly because 1 19 the standards seem to be very, very low that we're talking I 20 about, and it's not clear that there's much anxiety here as 21 far as health and safety is concerned. But I think the view 22 of the licensees that have to live under these roles is very 23 important for us to also hear. 24 Because they can speak the kinds of problems that 25 I am alluding to with direct experience, and that as i
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489 1 background information has always been very helpful, to me, (m) x/ 2 anyhow, in offering any kind of advice on these kind of 3 issues. 4 MR. CARDILE: I am sure that with regard to the 5 licensees who are going to have to face these dose levels, 6 that they will be well represented at these public meetings. 7 DR. GARRICK: yes. 8 MR. CARDILE: And also from the experience of the 9 cleanup rule, I am sure we will get plenty of letters or 10 comments. 11 DR. GARRICK: Yes. 12 MR. CARDILE: Written comments on whatever stage 13 we are in, including I am sure when the issues paper goes on 14 the streets, we will get some written reaction from the A g ,) t 15 nuclear industry, the NEI, you know, the various industries 16 saying we have no material, this is a waste of time. These 17 doses you are talking about are too low. 18 We got -- you know, like I say, the cleanup rule, 19 steps along the way generated quite a bit of information, 20 you know, written letters to us letting us know what is 21 reasonable, what is not reasonable. So that aspect, I have 22 no -- that piece of the world, I have no doubt, will let us 23 know what is going on. 24 I also have no doubt that the steel, given what we 25 have heard at a couple of meetings, that people who are [~') ANN RILEY & ASSOCIATES, LTD. \s > Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
p I ! 490 1 going ~to bc the immediate recipients of this material will () 2 3 let us know that these' doses are too high or too low, or are going'to cause havoc in their industry or not. 4 And then I have no doubt that, you know, at.least 5 ' convening'the process to get public' involvement, you know, 6 the general public, they will let us know whether they think 7 these doses are too high or too low. That was certainly our 8 experience inlthe cleanup rule, and.I expect that this-9 facilitator for this rule, both the' internal - -well, I 10 can't speak to the external facilitator, but the internal 11- facilitator for the cleanup rule is the same person who 12 worked on the -- for this rule'is the same one who worked on
-13 'the cleanup rule and is familiar with the parties and how to 14 get representation o,f the different parties and how to bring
() '15 that, you know, their views forward, so we should be pretty 16 well served. 17 In terms of looking at trying to give you better 18 information about what is-the univarse of materials-out 19 there, and the-situation out'there, there was -- an earlier H2 0 ' draft of this NUREG-1640 had a discussion of a literature l 21 survey of materials tnat were covered, you know, that would ! 22 be covered by something like this. I don't know if that was 23 ever published, but I would suspect.in succeeding documents
.24 _that we are going to have that type of information available 25 to you.
o : l l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 491 1 DR. GARRICK: Okay. Any other comments from (~ 2 members, staff? C)' 3 [No response.] 4 DR. GARRICK: We are grateful to your time 5 management in allowing us plenty of time to ask the 6 questions that we wanted, so we like that. Thank you very 7 much. I think that completes this topic. l 8 MR. HUFFERT: Okay. Thank you. 9 MR. CARDILE: Thank you. 10 DR. GARRICK: Thank you. Okay. What I would like 11 to do is maybe, given it is a long afternoon, is take -- 12 rather than one 15 minute break, we may take two 10 minute 13 breaks, and I would like to declare one right now, a 10 i l 14 minute break. I rh iJ 15 [ Recess.) 16 DR. GARRICK: We will come to order. We are now 17 going to hear from Nick Orlando on the decommissioning 18 standard review plan. 19 MR. ORLANDO: Thank you, Dr. Garrick. What I 20 would like to talk about today is just to give you all a 21 little update on the standard review plan. I think the 22 first time I talked to you about this was about six months 23 ago, and in that discussion I showed you a schedule where we 24 had incorporated some ACNW briefings and some requests for 25 input, and this is actually the briefing or request for l
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I 492 1 input that I was supposed to have for you a couple of months /} 2 ago, but-.we have snoplanted that with just an overall 3 program presentation, so that is what I am here to talk to 4 -you about today. 5 Just to give you a little bit of background 6 information, r.iind everybody, back in July of '98 the 7; commission gave the staff some direction to go forward with 8 .some guidance that the staff had put out, specifically the 9 DG-4006, said send that out for a two-year comment period 10 and maintain a dialogue with the public during the comment 11 period, develop a standard review plan that incorporates the 12 risk-informed iterative approach in NUREG-1549, and also 13 provide clear guidance on what we mean by ALARA when we 14 develop the SRP, review the potential conservatism in the D () .15 and D screening code, and test the D and D'model on some 16 sites and use that as a test bed for developing your
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17 ' standard review plan, and, finally, use.the probabilistic 18 approach in calculating the total effective dose equivalent , 19 to the. average member of the. critical group, which is the 20 dose target in the new license termination rule. 21 My little portion of that world is the development 22' of the standard review plan. The purpcse of the SRP is to 23 ' allow the staff to evaluate information that is submitted by 24 licensees, to support the decommissioning of their 25 facilities. We want to be able to do this in a timely and i O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
F 1 493 1 efficient manner. We have had concerns from licensees that ('~')) 2 our reviews take too long and that they tend to be
% { '
3 disjointed. 4 We also have to make sure that the decommissioning 5 can be conducted in accordance with all of our criteria and 1 6 at the end of the day, the licensee will have submitted all l j 7 the information the staff needs in order to make the 8 judgments about the standard review plan. 9 We had given you a description of the contents of 10 the standard review plan. If you are familiar with 11 NUREG-1199, where it talks about -- or where it sets out 1 12 acceptance criteria, and resources, and ans]ysis i 13 requirements and whatnot, the standard review plan will 14 follow that same basic format and content. O 15 i And then the very last bullet on the slide V' l 16 indicates that we will use this to review not o1._y 4 17 decommissioning plans but also other information. One of 18 the things that has come up since we started developing 19 this, at least from my perspective is the interplay of this 20 with the activities in the Office of Nuclear Reactor 21 Regulation. And I think because of the process we have been 22 going through, and because of the discussions we have been 23 having, that, at least for me, has gelled up very nicely and 24' we can talk about that a little later on when I get to the 25 question and answer period, so I will give you one question
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f- - i ! 1 L ! 494 j
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1 -you can ask me. [&
\ ~2 Okay. One of_the_ things that-the commission said 3 to do is make sure that-we continue having stakeholder 4 input, and to'do that the staff has and will continue to have~a-series of workshops on different aspects of the 6 . standard review plan. Now, we had the first workshop back l
7 in December, the 1st.and 2nd, of last year, and in that ' 8' workshop, we discussed specifically dose modeling. 9 We had a second workshop in January and we talked 4 10 about doce modeling.and restricted use scenarios -- or 11- license termination under restricted'use. I recognize that 12- these workshops are intended to facilitate a two-way 13 dialogue between the NRC staff and licensees. They can 14 raise issues to us, we can talk about them in an atmosphere () 15 of trying to figure out what the questions and the possible 16 solutions are. We can't go to the licensees or to the 17~ participants in the workshops and ask them for solutions 18 because we run' afoul of FACA if we do that, the Federal ; i
'19 Advisory Committee Act.
20 So, in some of the workshops we have had a lot of
- 21. data presentations. The last one, in particular, was 22 extremely symposia-like, but everybody seemed to enjoy that.
23 We talked a lot about some_of the issues facing the dose 24' modeling group. The last workshop in March was actually on 25 dose modeling the first day and ALARA issues the second. [] -ANN RILEY & ASSOCIATES, LTD. Court Reporters I. v ~ 1025 Connecticut Avenue, NW, Suite 1014 Wasnington, D.C. 20036 (202) 842-0034
495 1 .The way we have set it up, at least the last three, one day 2' was dose modeling and then the other day was another issue. 3 In June we are going to have this-third -- or the H 4 fourth workshop, and if you look at-your old schedule, that 5 was actually slated for I think~the 18th and 19th. We got 6 bumped because of the annual NRC awards ceremony, the 7 Presidential awards, and so we had to move that back to the ' 8 23rd and 24th. And in that workshop, we are linking that to 9 a workshop that Tom Nicholson and Research is havd.ng on ; 10 groundwater, so there will be four days of groundwater 11 .modeling issues being discussed. 12 The August workshop, we are going to talk about 13 comments that we have received'to date on the D and D 14 screen, and either discuss surveys or discuss questions or 15 ~ issues that are identified by the agreement states. One of 16' the persons who is -- or one of the participants in the 17 wodshop has been Dave Zamori from the New Jersey Department 18 of Environmental Protection. He is representing the Council 19- of Radiation Control Program Directors, and he has requested 20 a day for the states to come in and present-what they think 21 the issues are and questions and problems they see having. 22 So I am not sure if'we are going to do that in August or 23 October. Originally, we-thought we would do it in October, ; 24 but the agreement states are kind of indicating they would
-25 like to do it earlier as opposed to later. And then if we t' ANN RILEY & ASSOCIATES, LTD.
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I l 496 ' ( 1 don't do' agreement state issues in. October, we will do i 2 surveys. L 3 Now, as far as some of the milestones --
<4 DR. GARRICK: Are you going to tell us a little i
5 bit about what you have learned from the workshops? I 6 MR. ORLANDO: Well, one of the other handouts I i l 7 gave you was a list of issues that had been identified. i 8 Some of.those are issues that came out of the workshops. 9 Some of those are staff generated issues. I can discuss a 10 little bit about some of the observations I think that we l 11 .saw in the workshops. 12 DR. GARRICK: I am especially interested in 13 anything that led to changes or revisions or anything that 14 was significant enough t. hat it changed your way of doing 15 business. J 16 MR. ORLANDO: Okay. And_to remind you, the I 17 milestones that we have established or set up so far, we are i 18 still-on track pretty much. We have established the work 19 groups. We have developed the default tables and published
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20 that in November of '98. And we have identified the issues 1 1 21 needed to comply -- or to start developing the draft SRP' ) 22 modules. 23 We still hope-to finish development of the drafts 24 by June and then close -- and then revise those by May of i 25 next year, and then submit the final draft SRP for review in f i i ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1 1025 Connecticut Avenue, NW, Suite 1014 I Washington, D.C. 20036 (202) 842-0034 i
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p 497
.1 the summer of 2000.
'2- We have had several challenges, as you may or may
.3 not be aware. Specifically, we lost son,,3 folks, Dave Fauver l
l- 4 has moved on to _ private industry. He was one of the group 5 leaders for the surveys module. He was also heavily 6 involved in the dose modeling. group. To offset that, we ' 7 have contracted with the Oak Ridge' Institute for Scienc- and 8 Education to help us develop the surveys component. In 9 addition, Tim Harris is going to be working with the dose 10 modeling group -- Tim Harris is in my section -- is going to 11 be working with the dose modeling group to take up some of 12 the work that Dave had been doing. 13- Richard Tretill, who was originally slated to head I up the group on financial assurance has rotated out, and I 15 am not sure when he is going to come back, so we have asked 16 ICF, Kaiser, who does a lot of our decommissioning,- 17 financial assurance reviews, to come in and write that 18- portion of_the standard review plan. It will be written by 19 --those folks but overseen by NRC folks.
;20 In addition, there have been some other staff 21 moving around a little bit,.but we think we can still catch i
22 up and get done what we need to get done. ; 23 The -- let's see, I seem to have lost my issues
- 24. one. The very last slide in your packet is a list of issues 25 requiring resolution. Instead of taking all of the issues
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E~ l ! l l 1 498 i 1 on the second handout and trying to make slides on them, (} 2 what I thought I would do would be to give you those, let L 3_ you look at them at your leisure. You can think about them. 4 We can discuss a little oit some of the thoughts that I am 5 having, or that some of the work groups are having. 6 Bobby Eid is in the back -- or on the side. He 7 can talk about some of the issues associated with dose 8 modeling. I can talk about restricted use and some of the ! 1 9 other modules. And, you know, we can talk about that a 10 little bit if you would like, or we can just talk about the 11 workshops, as you have indicated, or just about anything 12 else. I just wanted to give you an update as to where we 13 were with everything. 14 We have met the milestone of identifying the () 15 issues and one of the things we raid we were going to do 16 when we did that was give them to you and let you all think 17 about them, too. So that, believe it or not, concludes my 18 formal ~ presentation and maybe you will thank me, too, for 19 giving you all kinds of' time to ask questions now, till 20 5:30, 21 MR. LARSON: You have prepared some answers that 22 you have given in some of these public workshops to some of 23 the questions on these issues. 24 MR. ORLANDO: We have thought about some of the 25 answers, yes. [} (_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW , Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
499 1 MR. LARSON: Well, I have been at some of them,
-( ) 2' and so has Dr. Wymer, where you have talked about - von 3 have given the questions in writing and given the answers 4 orally.
5 MR. ORLANDO: Verbally, i ! 6 MR. LARSON: But I mean you have got answers to 7 some of these. 8 MR. ORLANDO: Yes. 9 MR. LARSON: So if the members had some questions, 10 they could ask. 11' MR. ORLANDO: Certainly. But, of course, you 12 know, those are, as I said in those venues, those haven't 13 been translated into actual draft standard review plan 14 acceptance criteria or anything yet,-they are just sort of ( 15 .the staff's working thoughts on a lot'of them. 16 DR. HORNBERGER: Which do you consider the most 17 sticky wickets on this list of issues that is behind you? 18 MR. ORLANDO: Dose modeling. 19 DR. HORNBERGER: Dose modeling? 20 MR. ORLANDO: Without a doubt. The most work, the 21 most technical issues. Quite frankly, for health and safety 22 plan surveys and financial assurance, I think, in general, 23 those are going to be pretty easy to do. I mean it is just 24 the process of writing down what we want. 25 It-is kind of interesting, for health and safety N ANN RILEY & ASSOCIATES, LTD. s_ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
500 1 plans, there is guidance out there on what we want. () 2 There's a lot of health and safety plans that 3- have been. written. There are some very good health and 4 safety plans. Financial-assurance -- there's just so many 5 things that we're going to accept: surety bonds, statements 6 of intent by federal facilities, you know, external sinking 7 funds, things like that. We don't'have a whole lot of 8 wiggle room. The regs are pretty clear. 9 Dose modeling? You know, we have a code, and, you 10 know, how are you going to move from specific -- excuse me 11- -- from screening to site specific, how are you going to 12 factor in these difficult cases, things like that. 13 I'm writing a lot of the modules that aren't on 14 here, for example, facility operating history, you know, D) (_, 15 things like that, and those you have to generate from whole 16 cloth. But clearly from a technical standpoint, dose 17 modeling is going to be the tough one. 18 DR. HORNBERGER: I would be interested in hearing 19 some more discussion about dose modeling, but before we do 20 that, do you have a gut-level feeling about how you're going 21 to handle ALARA? 22 MR. ORLANDO: -Chris McKinney unfortunately is not 23 here, he's out in New Mexico today, but he has identified 24 some of the issues. .The principal issue with ALARA is 25 making sure that it's an a priori kind of an assessment. ANN RILEY & ASSOCIATES, LTD.
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7 i i l I 501 1 There is a lot of concern -- ALARA can kind of be handled i - ,s , (G) 2 two ways, I mean, you know, sort of traditionally, you can 3 look at it and say, well, here's my dose and that's the 4 amount of material in the dirt or that I'm shooting for, and 5 the dose I'm going to get from that, and if I clean up six 6 more inches, how much is that going to cost and what's the 7 dose benefit. 8 There's also what Chris likes to think of as
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9 rolling ALARA assessments where you're doing those kinds of ' 10 things as you're looking at imbedded pipe and as you're 11 looking at each -- as you come across individual situations 12 at the site, where perhaps you would maybe not have as good 13 characterization as you need. So you start chasing 14 contamination through the soil. ; p) i, 15 Well, all of a sudden, you've got to start making 16 ALARA assessments at that point, because if you thought it 17 was going to take X amount of money to clean up to a certain l 18 level -- don't forget, ALARA is below 25, so we're already, l 19 you know, safe. 20 If you wanted to take it to 23, all of a sudden, 2 1- if you've got to dig 75 more feet or 75 more cubic feet of 22 dirt out at a cost of a couple of thousand dollars a cubic 23 foot, all of a sudden, you've got to start making ALARA 24 assessments at that point, and those are the kinds of things 25 that he's having -- wants to get, you know, down. l I [T
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502 l 1 MR. LARSON: Yes, but the SRM on ALARA said that i () 2 in addition, if the licensee complies with the 25 millirem dose criterion using the screening, the licensee will emit l 4 the intended ALARA requirement and additional demonstrations 5 may not be necessary. 6 MR.HORLANDO: That's for soil. 7 MR. LARSON: Okay. 8 DR. HORNBERGER: But as far as the dose modeling 9 goes, you're first overhead related to the D and D code and 10 testing it at a complex site, et cetera, et cetera. 11 MR. ORLANDO: Yes, sir. 12 DR. HORNBERGER: Tell me a little about the dose-
~
13 modeling and to what extent does it cover what was on the
.14 first of your overheads and to what extent does it go beyond
() 15 it for'more complex sites. You mentioned site specific. 16 How is this all going to play out? 17- MR. ORLANDO: Okay. If I can, I would like to 18 turn it over to Bob Eid. He's the project or the group 19 leader for the dose modeling group. If that's all right 20 with you all since he's the one who --
-21 DR. GARRICK: Yes. I think that would be good.
22 MR. EID: Good afternoon. My name is Bob Eid. I 23 am here to answer your questions about dose modeling. I 24 will try. 25 As you know, dose modeling is very complex, lots ANN RILEY & ASSOCIATES, LTD. O- Court Reporters b 1025 Connecticut Avenue, NW, Suite 1014 : Washington, D.C. 20036 l (202) 842-0034
! 503 l 1 of issues. We try to deal with the issues as much as we () 2 can. We try to interact with the users also to look into l 3 what are the issues that they face when trying to use the 4 current tools that we have or the tools currently available
- 5 for dose modeling.
1 6 As you know, the current tools for dose modeling, 7 most licensees, they use -- they have two options. They 8 have the D&D version 1 code that we have, and this is the 9 NRC code, and we said this is e screening code, it's for a 10 two-year period. We found that also the license, mostly 11 they use RESRAD. The licensees tend to use more RESRAD 12 rather than D&D screen. 13 Now, you asked the question about what are the 14 issues in dose modeling. There are so many issues --'where 15 to start? 16 Let's first see, just to give you two or three or 17 maybe four issues, for the current code that we have, 18 version 1, we have the issue regarding alpha emitters for 19 surface contamination. The alpha emitters for surface 20 contamination, DCGL, those guidelines -- currently they are 21 very low. They are not detected at all within the limit or 22 with the fluctuational background. That's an issue. We 23 struggled with that issue early in the process. We tried to 24 generate default tables for licensees to use. We were 25 successful in generating default tables on D&D version 1 for
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504 1 beta and gamma emitters, but we were unsuccessful in 2 developing default tables for alpha emitters. That's the [} 3 first issue. 4~ The second issue that we have about the 5 methodology of D&D version 1.0, the methodology we tried to 6; -- NMSS staff expressed their concern from the beginning 7 that the current methocology tended to exaggerate or to be 8 conservative, such that there would be a dose, higher dose 9 that maybe is not needed -- in other words, to increase the ,
'I 10 risk -- and the answer was, well, this is screeninq !
11 methodology and we understood that. But I guess there were 12 presentations also in this regard, and everybody understood 13 yes, it is screening and we like to take it as screening 14 methodology and we should accept that excessive dose. () 15 Now, working with the code, we found that from 16 this workshop, they were very usual, that the licensees, 17' they did use the code, and they came with numbers, and they 18 found that for certain radionuclides, these doses, they are 19 practically unacceptable for them, and-they called them 20 anomalies. An example for those, they are the cesium values 21 and the strontium 90 values. 22 To put you in perspective, if you are interested 23 in knowing numbers, the current version 1.0 produces doses 24 for unit concentration, one pico curie per gram, of about 25 around 60 millirem per pico curie per gram. However, if we ANN RILEY & ASSOCIATES, LTD. 0+ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
L l I 505 l 1 use, you know, the Sanuleta report where they listed single ( 1 2 radionuclide source, they assume not all radionuclide ( [~}/. s-3 source, all come back to the reason behind this extra dose, 4 that it is -- you will find that the value could be 14 5 millirem for strontium 90. For cesium, the unit 6 concentration dose currently in D&D version 1 would produce 7 about 28 millirem, whereas in the report using single 8 radionuclide value, would produce -- also be around fre.ction 9 of millirem. So you could see the difference in the doses. I I 10 The reason for having these extra doses currently, I 11 because the methodology tends to be over-conservative and I 12 tried to assume that you have all radionuclides listed in l 13 the table at your source. 14 So in other words, just to articulate this, to be l (^5 ( ,) 15 honest in my giving you the presentation to reflect also 16 research point of view according to what they said, okay, 17 these anomalies in the version 1.0 for some radionuclides -- 18 again, not for all radionuclides -- they're related to the l 19 high dose values generated using version 1 as compared to Y 20 using single radionuclide input, and they are called both 21 artifact of the current methodology to select a solution 22 representing the single default set for all radionuclides. 23 That's what the have. And this is -- I guess it's a ! 24 significant issue. The question, is this such kind of high ! 25 difference in the dose, and everybody recognize that extra i l O. ANN RILEY & ASSOCIATES, LTD. Court Reporters f(ms 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (,' n 2 ) 842-0034 t
. .s 506 1 dose there is not needed, because at the end, you have a 2 default parameter that's indeed for when you have all 3 radionuclides to establish single set or default parameter j
'4 'for all radionuclides sources, you.will end not with the 5 90th percentile.of certain parameters, you will end with the' 6 99.9 percentile of that parameter. So this is -- that's, 7 you know, I think a serious ~ thing that we need to consider, 8 whether to -- you to accept whether the licensee can accept 9 this extra dose between one millirem or 28 millirem or 10 between 14 and 16 millirem or not.
11 If we agree that it is not -- it is an excessive 12 dose that is not needed, then maybe you will need to modify 13 the methodology currently and D&D. 14 The answer to the question of what to do about it () 15 already exists, and it was realized earlier that'the -- 16 possibly this excessive dose could be resolved by having the 17 Monte Carlo version, where in the Monte Carlo version, you 18 try to avoid -- you put your single radionuclide or the 19 mixture of the radionuclides that you have and then develop 20 default parameter, see if that corresponds to these kind of 21 scores. So by doing this, you will minimize this kind of 22 excessive dose that's currently in D&D version 1.0. 23 Another third issue also, the input parameters in 24 the current code, and we talked about it and we caid this 25 ' represents all kind of conditions across the United States, O
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507 1 ' represents all radionuclides, and these input parameters, a () 2
.3 they are conservative somehow.
We found there are certain parameters that are 4 quite conservative. Almost there is consensus among the { L 5' group that they need to be changed. An example of those is i 6- the. mass loading factor for plant reposition, and this is a 7 number almost everybody agreed that needs to be changed. ; 8 Another factor which we spent lots of time in the 9 discussion in the dose modeling group'is the resuspension 10 factor for indoor. The resuspension factor for indoor, we 11 find the PDF is constructed on data which was taken in 1964, 12 published data, and the number of data points here are two,
.13 although they were also data points for that specific 14 reference that was quoted.
((~N j)- 15 We tried to look at the PDF again to look l l 16 critically at what kind of data we have, and we find we 17 understand that yes, it is conservative. We were at first 18 with the situation, okay, what to do about it, what E19 alternatives we have. We found that we need additional 20 data. 21 We tried to look at additional data, and the 1 22 workshops, they were very successful trying to communicate l 23 with the industry and plead for them to give us whatever 24 site-specific data they have. I would like to record that
-25 we were very successful on the one that -- the industry i
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r '. 508 1 cooperated at the workshop. They were so successful in 2 getting actual data that were measured over years by the 3 licensee that they were not aware of, and there were several 4 presentations about resuspension factors by industry. There 5 were honest and true presentations by us-and new 6 suggestions. 7 I think possibly, if -- still we are not in 8 complete agreement-within the group. If we agree, we have 9 consensus agreement, we could move forward to modify 10 resuspension factor. If we do that, based on our 11 recommendation that not everybody agrees, of course -- as
- 12. you know, this is technical discussion not everybody agrees 13 on. If we move forward this that, we could modify the alpha 14 surface contaminations by possibly a factor of 18 to 20, and 15- we will be now in the working region, the measurable region
-16 of dose.
17 Those are some of the issues. There are other 18 issues that, you know, I would like to give you more time if 19 you would like to ask any other questions. 20 DR. HORNBERGER: Just a short follow up perhaps. I 21 What you've described, you're right, I mean, these are 22 intaresting technical issues. It appears to me that you 23 have your ideas well in hand for how you're going to collect 24 data and perhaps modify the code and change default 25 settings. In other words, you've given us a good indication 4 ANN RILEY & ASSOCIATES, LTD.
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509 L .1- that you have the road pretty clearly mapped out in frort of I l
- Nf~' 2 you as to how you're going to solve these technical 3' problems.
4 Do you see any-technical problems din the dose l. 5 modeling that you don't have a clear idea of how you're I 6- going -- that-is, are there some big questions that really 7 aren't even resolved conceptually? ! 8' MR. EID: Really,'I do not know specifically. The 9 .only problems that I know, that the licensees.are using one 10 code and we have another code,,and we are trying to use and 11 to improve n._ code as much as we can to make it more useful 12 for screening. Our code has limitation, as I said before, 13 and we cried to balance to see what are the. limitations and 14 to-what extent we can use our code, and to what extent that () 15 we could allow the licensees to use our other codes and how 16 we evaluate that. 17 We found that RESRAD, as you know, is a very 18 popular code used by the licensees. Now the question is, 19 when the licensees, they submit RESRAD to us,.we have no 20 information about~how to assist the conservatism in RESRAD, 21 how to assist these parameters. We are working on that. 22 But also, we need to start with this -- the Commission, they 23 told us~t'o have risk-informed, you know, based regulations, 24 so try to look at RESRAD, and currently it's more L25 deterministic. They are working on a probablistic version,
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510 I which is not workable. So that's the reason we tried to
/~')
NJ 2 develop -- we developed a scope of work for RESRAD, a RESRAD 3 probablistic, and we tried to have some kind of similar l
}
- 4. approach which we adopted, actually, the probabilistic )
5 approach. That's one of the issues that we struggled at the 6 beginning, to go to probabilistic or deterministic. We 7 agreed that we'would like to go to the probabilistic, l 8 although we cannot completely say, if licensees submitted i 9 deterministic with sufficient justification, just ignore'it 10 completely, but we've said that's the route we'd like to 11 see. 12 Therefore, we are working on it such that if I 13 licensees, they submitted RESRAD for site-specific analysis 14 so we could have a feeling and we could have the tool to () 15 assist what kind of conservative assumption they have. The 16 question is, can you use other codes for screening analysis. 17 Then the issue will be, you have two default values, for 18 example, and how you deal with that. 19' I think if we succeed in modifying our code 20 ~ currently and we have trust that yes, the numbers are 21 workable, they are good and they are prudently conservative 22 rather than excessively conservative, I could say that it is 23 a step forward. 24' Possibly we may find out that there are some 25 comparable results between -- if we have probabilistic l ANN RILEY & ASSOCIATES, LTD.
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q 511 1- RESRAD -- between RESRAD and D&D. So if we do that and they
) 2. are comparable within,.say, 10, 20 percent, I mean, okay, we 3 will accept that. We could say you could use any code even 4 for screening. .But currently, because we do not have l 5 sufficient confidence in the level of uncertainty and 6 confidence in the dose levels that are derived, we say we )
i l 7 will use D&D screen for screening. However, for site 8 specific, the licensees-could use any other code, but they 9 have to do, you know, the uncertainties and additional l 10 justification' based on site-specific conditions. 11 DR. GARRICK: Can you say a few things about what 12 you're actually doing to make the analysis probabilistic? 13 MR. EIE : Yes. What we are doing, already, as you 14 know, D&D is a -- it is originally probabilistic but () 15 currently version 1, it is not probabilistic, it is 16 deterministic, because the input parameters, they are single 17 default data, they are inputted in the code. So the PDFs j 18 for the different parameters were selected based on j l 19- .probabilistic approach; however, they are sing 3a values 1 20 currently in version 1. But we are doing work --'I guess 21- there was a previous presentation by.Research about
~
22 . developing a Monte Carlo version of D&D. It's called 23 version 2.0, So we are hoping this version will be 24 accessible to use by the staff and the licensee as soon as 25 possible. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
p 512
- 1. Our information, that this will be within six to I() 2 nine months, that would be produced assuming that the 3 contract is placed.
l 4 DR. GARRICK: How are you going to obtain the PDF 5 input parameters?
-6 MR. EID: For RESRAD or D&D ' cur -- l I 7 DR. GARRICK: D&D, yes.
l l 8 MR. EID: For D&D, already there are PDFs, but 9 they were used for, you know, at the beginning, to start 10 with, for singular radionuclides. And then we tried to j 11 generate PDFs by having mixing those -- all of these 12 radionuclides, mixing them together. I tried to generate a 13 dose which is, say, the 90th percentile of the dose based on 14 those PDFs. So the version -- this is version one, version i
.f"% I ' ( ,) 15 two will try to input the PDFs that they could respond to l 16 that-radionuclide mixture or to that specific radionuclide.
17 For example, currently, the code will assume all j i 18 radionuclides that you have there and will try to modify 19 those PDFs slightly in order to accommodate ~the 90th I i 20 percentile level confidence for all radionuclides, 21 regardless whether it does exist or does not exist. 22 The version two, it will only account for the PDS 23 that correspond only to the radionuclide present at the l 24 specific site. 25 DR. GARRICK: So is that how you deal with the [k ANN RILEY & ASSOCIATES, LTD.
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'i 513 l' site specificity?
L 2 MR. EID: Right. 3: DR nGARRICK: .Because the screening -- when it's
~4 ' screening, it's.really not probabilistic because it's a 5 table of PDFs, right?
6 MR.<EID: That's' correct. 7 DR~ GARRICK: All right. j . 8 MR..EID: That's correct. .So hopefully, possibly 9 Eif we find that -- from Monte Carlo version, we may look at, l .10 say, fuel cycle facilities, they_5 Tve specific 11- radionuclides, could be five, six or ten radionuclides,_so l 12 you run the code and see those correspond to this kind of 13 source term; or if you have'a nuclear power generator 14 facility that. has a specific source term, you only consider (/ 15' radionuclides for that specific' source, you do not need to 16 consider other kinds of radionuclides, that they may be an 17 outlier causing the dose to be'very high. L 18 DR. GARRICK: Yes. 19: Ray? l 20- DR. WYMER: Well, I did attend the January working 21 . group meeting, and I thought there was a lot of good- ! 2 2_- interplay between the industry and the staff and found a lot 23 of receptiveness in the staff to the ideas that the~ industry 24 came'out with. 25- .One thing that struck me, however, was that there l ['~' ANN RILEY &-ASSOCIATES, LTD. Court Reporters ,, 1025 Connecticut Avenue, NW, Suite 1014 Washington,_D.C. 20036
'(202) 842-0034 L
514 1 seemed to be, at least among a few of the industry people () 2 3 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 4 ' works, we've been using, we're happy with it, we've got 5 experienced people with it. So we're still in that sort of 6 dilemma of having two different approaches. 7 What can you say about that now, Nick? l l 8 MR. ORLANDO: Well, I'll say what Cheryl Trottier 9 said at the last workshop whenever a question was asked, and 10 that's that D&D was an NRC staff code, it was developed, and 11 it was -- since we had it, it was put on the street for use. 12 I think Bobby indicated that,'you know, it's 13 appropriate for screening right now, and that if licensees 14 want to use that or RESRAD, they can come in and just f% g ,) . 15 negotiate with the staff on which one they're going to use. 16 DR. WYMER: I have a recollection that the two 17 codes didn't always come up with the same answer for the 18 same situation. 19 MR. ORLANDO: And I think that's one of the things 20 the dose modeling. group is looking at, is trying to make 21 sure that, you know, when the program version comes out or 22 other versions of RESRAD come out or the input parameters. 23 that would go into the RESRAD, the doses will be coming out 24 closer or, you know, within -- . 25 DR. WYMER: Within acceptable -- ['N x ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 , (202) 842-0034 1
515 1 MR. ORLANDO: Within an acceptable range, I should l- 2 'say. 3 MR. NELSON: This is Bob Nelson from Division of 4 Waste Management. I would like to address that question, 5 RESRAD versus D&D. i 6 We've said this several times during the workshops l 7 and it's important to stress that D&D was only intended 8 originally as a screenirg code. Because it was intended as l l 9 a screening code, the default parameters set were set at a l 10 very high confidence level to achieve -- so that you would 11 achieve a 25 millirem dose, and they were set based on 12 probability distributions of the various input parameters, 13 and because it was a screening code, the ultimate numbers 14 were chosen, had to consider already nuclides. () 15 So regardless of what radionuclide you put.into 16 the code, you're going to come up -- the default parameters ! 17 stay the same. That's one of the problems with using it in 18 a site-specific way that Bobby has talked about.
- 19. The RESRAD -- the basic difference between RESRAD 20 -- one of the basic differences between the two codes is the i
21 defaults-that are used. They were not determined the same i 22 way. The default parameters for RESRAD were determined 23- deterministically based on expert judgment. 24 So one of the things that we are doing is 25 developing under-a contract -- Mark, maybe you can -- with f
\ ,)-
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r I. : l l 516 ! 1 Argonne to develop a same type of probabilistic default (~') 2 parameter sat for RESRAD as was developed for D&D so that we 1 O 3 have basically an apples and apples comparison rather th .. 4 an apples and oranges comparison. I think that will 5 eliminate some of the confusion between the two codes. 6 As Bobby talked about, we're developing the Monte 7 Carlo front end to D&D to eliminate this problem of not 8 being able to look at specific radionuclides and getting a 9 more realistic dose out of the code. 10 Both of these, of course, require time to 11 implement. The D&D Monte Carlo version won't be even at a 12 beta -- test version won't be ready until, right, nine 13 months, sometime in the Fall, and a final version won't be 14 out until about a year from now. So we have this interim ( 15 period where we still have what we've got. l 16 DR. WYMER: How will it impact your two-year 17 let's-see-what-it-does period? 18 MR. ORLANDO: That two-year is -- that's for the 19 dose -- the draft guidance GG-4006. That was put out, and 1 20 the comment period on that closes this year, August of this 21 year. 22 DR. WYMER: But the trial runs will be done with 23 the existing version. 24 MR. ORLANDO: I guess what I'm saying is there was 25 no Commission-directed two-year time frame for evaluating l (~N ANN RILEY & ASSOCIATES, LTD. l ' (,_,) Court Reporters ! 1025 Connect'. cut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
517 1 the code. 2 DR. WYMER: Okay 3 MR. NELSON: One other point I wanted to make, 4 that even once we have these -- so we are on a path to
- 5. getting better -- code working tools out there, but we still 6 have another issue with the codes. Once -- even if you have 7 these probabilistic determined defaults in both codes that 8 are.similar, how do you change to go from a -- the default 9 to a' site-specific parameter? And if you change one 10 parameter, how does that impact the other parameters? What 11 linkages are there and what other parameters do you have to
.12 consider when'you consider changing a parameter?
13 That's another issue that the dose modelling 14 working. group will'be addressing during this development () 15 period, and some of the guidance we're going to have to put 16 out is how do you change default parameters, what 17 justification do you have to supply to' change from default 18 parameters to site-specific parameters.
- 19. DR. WYMER: That does a good job of answering my 20 question.
21 DR. GARRICK: I guess I'm still struggling a 22 .little bit with the merit of a Monte Carlo calculation at 23 the screening level where, you know, uncertainty and 24 probabilistic has meaning if you're talking about a specifi'c 25 situation. But when-you're talking about a generic O ANN RILEY & ASSOCIATES, LE. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
r 518 1 situation, I'm having trouble rationalizing what that means. I~ V) 2 I mean, if you're just trying to demonstrate that Monte 3 Carlo can.do probabilistic arithmetic, you know, we know 4 that, but what's the significance of it? 5 MR. EID: I agree with you. I think the -- at the 6 end, if you think that you have all sorts of mixtures of 7 radionuclides at your site and all sorts of environmental b conditions and then you need to go look at the 90th 9 percentile, and then when you apply it, you find that you 10 are not at the 90th percentile, you are at the 99th 11 percentile, you will have excessive dose for sure. The 12 question is what to do about it. This issue was raised and ! 13 there was a suggestion for a grouping. 14 I guess there was also a suggestion by the ACNW, l (~3 r (_,/ 15 by the way, about almost -- how many months? -- nine months
)
1 16 ago in the presentation about the grouping of radionuclides, j 17 for example, uranium and thorium, or other kinds of i 18 radionuclides. This way, you could reduce the extent of 19 conservatism in this process, grouping possibly on -- based 20 on soil tyoes, that you don't need to have KD value that
]
i 21 corresponds to all kinds of soil types and all types of 22 geochemical conditions, a grouping possibly based on 23 environmental conditions like rainfall. So those are the 24 possibilities that, you know, we could do as far as 25 screening.
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7 519 1 MR. EID: This is Mark Thaggard. Would you like
-. ' 2 to-add onto that?
3- MR. THAGGARD: Yes. I think your question is why 4 are we trying to calculate the probability on this. I think 5' the original idea was to try to come up with the confidence 6~ 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 8 the dose-assessment analysis with no information about the 9 site, these -- PDF is " Rosed to be based on national data, 10 so'if you take any site in the country, just randomly. pick a .
I 11 site no know nothing about that site, and you.run a dose 12 assessment, what is the probability that you're making a 13 mistake by releasing this site when, in fact, you shouldn't 14 be releasing it. This was the original idea of trying to () 15- come up with a probability. It was to give us some level of 16 confidence in terms of whether we are releasing sites that l 17 we shouldn't be releasing, and there's some debate as to 18 whether or not we--are correctly quantifying that, but that i 19 was the original intent. ' 20 I don't know if that answers your question. ! 21 DR. GARRICK: I think that's an expression of 22 honesty. 23 MR. NELSON: I would like to follow up on that, l
- 24 because Bobby brought up an example-during his discussion of ,
25 an existing problem where, if you run RESRAD as it -- or D&D j O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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520 1 .as it is now for strontium and cesium, you get ridiculously , 2 high numbers. ( They don't make. sense. And that's because 3 the default parameters set has been' established based on all 4 . radionuclides rather than given radionuclides or a given j 5 mixture. 6 What.the Monte Carlo version will be able to do ir 7' you'll be able to put in a specific mixture, it will 8 calculate the default parameter set for that specific 9 mixture and give you a screening-value for that mixture.
.10 - We have done that. Bobby has looked at that for 11 the strontium and cesium, and have compared-it to RESRAD,
-12 ~ and the values, once -- when you do this for a specific 13 radionuclide mixture, they come much closer to what RESRAD 14 would give you for the same calculation. They're not exact,
() 15' but they're within'an order of magnitude closer. 16- So that's the value. It's still a screening tool, 17 but it gives you a better screening value, a more realistic 18 . screening value based on the radionuclides you have rather 19 than assuming that every radionuclide that -- is there.
-20 -DR. HORNBERGER: When you say it gives you a more 21 realistic value, more realistic compared to real data or 22 more realistic compared to RESRAD, which we don't know what 23 the result means anyway.
24 MR. NELSON: Well, when I say realism, I guess 25 it's a subjective realism. When you look at what D&D gives (~)
-\-
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r, 521 i l 1 you for strontium 90 at a pico curie per gram and it says j 2 that your dose is going to be 60 millirem per year, that, to t 3 me, is unreasonable. Okay. So by lowering the number, that i p 4 becomes to me more realistic. Whether it's the exact right i 5 number or not, I don't know, but it certainly gives you an 6 answer that you don't say,. well, that answer is worthless, i l 7 60 millirem. Of course it's not 60 millirem. 8 So in the calculations that we ran, and these were ; 9 preliminary numbers, but the strontium dose went from 60 t 10 under current D&D to a little under 15 with the Monte Carlo ' i 11 approach, and that's compared to about five for RESRAD. So l 12 it's a significant change for someone who is doing a 13 screening review. I mean, if they can pass it at 15, but 14 they've got -- if they've got 15 or somewhere in that range l (O j 15 and they're stuck with trying to screen 60, I mean, there's l 16 just -- you know, it seems a significant difference there. 17 So I think it's -- I think the code -- the l 18 improvement is of great benefit in the screening area 19 because it's going to give numbers that are tailored to the 20 radionuclides that are of interest. . 21 MR. LARSON: I didn't think it was two codes that i l 22 were similar for each different radionuclide. That's for l l 23 some radionuclides, one was higher than the other, and 24 depending -- you know, so -- it sounds like there was a lot 25 of changing that you had to do to get similar realistic or i i t O APN RILEY & ASSOCIATES, LTD. (s,/. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 C
F l l 522 1 unrealistic results for each of the radionuclides. () 2 3 different. MR. EID: I believe the two models here are They would yield somehow different values. l i ' l 4. However, if you try to adjust the source term to make it 5 similar, say make RESRAD, the top 15, the contamination the l 6 top 15 centimeter, and the thickness of the unsaturated zone l 7 around one meter, that's one thing to try to shape your 8 source term, to make it similar to D&D, and then try to 9 input a default value similar to what we have in D&D, you 10 will get, somehow, some comparable values. 11 An example for cesium, I found that the -- after 12 -- you know, for a single radionuclide, if you do that, you. I 13 will get 2.27 and 2.3. It is not a joke, those are real 14 numbers. I ran them. They are so close to each other. l () 15 So the models possibly -- yes, we had differences i 16 in the models, and we may have differences in the peak dose i 17 at the time, I guess. You know, this is also another l 18 ' difference because one model tends to retard, other m?ael 19 tends to have infiltration and the material moves much 20 faster through the aquifer. 21 However, at the end, it looks like the numbers are 22 similar if you adjust the source term, the default values, 23 and if you lock at the right time for the peak dose. 24 DR. GARRICK: Do you want to say anything more 25 about the workshops themselves and how they went? l
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- i 523 1 MR. ORLANDO: Well, as Boby said, based on the
(} 2 comments that.we got from the participants, they were
'3 extremely appreciate of the fact just in general that the 4 staff is doing this outreach before we write down what we I 5 think the answers are.
6 There is concern from the industry on exactly some 7- of the issues that you raised -- you know, why do we have
'8 'two codes? You know, what 's going on here'.'
9 The industry, my impression, and this is just my
,10 impression from the workshops and it may be rather 11- simplistic observations, but the industry, especially the 12 nuclear power industry, is extremely concerned right now 1 13 about costs. They always have been, but with deregulation, 14 I think they're even more concerned. They are concerned
() 15 about making sure what they do is being done 16 cost-effectively in decommissioning. 17 For example, they are very interested in seeing if
- 18 they can't take their thousand-acre site that is 95 percent 19 buffer zone and getting it down to something that includes 20 the parking lot, the reactor building, and the areas that I 21 .actually have been impacted by operations. They don't want 22 to be in a situation where they're out surveying via MARSSIM
- 23. woods. So that's things-that they've come to us and talked 24 about.
25 In addition, they are interested in making sure I i
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P 1 524 1 that when they do the assessments that we're going to ask
; 2 k
['\ N./ for -- and one of the reactors have indicated they're going j j 3 to come in for restricted use. In fact, Paul Genoa from NEI ' 4 has said that's not going -- that none of them are planning 5 that right now. But they have come in and I think they're 6 concerned about finality. They realize that, you know, the 7 license termination rule is relatively new, the Part 50 rule 8 is relatively new, they're struggling with sending in the 9 first post-shutdown facility decommissioning activities i 10 report, the PSDARs are just starting to come in. That's the I 11 first thing that comes in when you shut down a reactor, or I 12 after the certification. 13 Nobody sent in a licensed termination plan yet. 14 They're interested in the interlink between the C R( ,)h 15 decommissioning plan standard review plan and the license 16 termination plan review. 17 One of the things we did at the last workshop was 18 very -- this question came up, and we did a very quick sort 19 of ad hoc overview of the interaction between NMSS and NRR 20 with respect to reviewing license termination plans and 21 decommissioning plans, and I'm not sure that the industry 22 understood that, at least the power plants didn't. 23 On the materials side, their concerns are the 24 same. They see -- they're more used to dealing with 25 decommissioning plan concepts and things, so it's not too e-~s I
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f. 525 1 bad, but they still have the concerns that the power 2 industry has, finality, making sure that what they send in l i 3 is done, doesn't generate reams and reams and reams of i 4 requests for' additional information and additional 5 justification and everything else. 6' One of the things that my management has told us 7 is that they want to see us start limiting the numbers of 8- requests for additional information to one. Have the 9 interactions with the industry.during the reviews of the 10 plans, publicly notice it, publicly -- make that information 11 publicly available, but don't have ten or five or three, you 12 know, sets of 60 questions going back and forth. 13 Then there are the technical questions,.looking at 14 -- you know, finding alpha emitters, measuring that under 15 the MARSSIM, partial site release even for fuel facility ! 16 plants, things like that. 17 So I think, to sum it all up as far as the { 18 workshops, I think they've been good. I think the industry l 19 appreciates the fact that we're doing this. I think they 20 are slowly -- probably not by this time -- they're 21 comfortable.with coming in and talking to the staff about 22 things that they find and problems that they have. So I 23 think they've been good. 24 That's.just sort of my observations on the things 25 that have come up and the things that I. heard while I'm ANN RILEY & ASSOCIATES, LTD. L Court Reporters [ 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
U ; L L l [ 526 l 1 sitting there in the workshops. l () 2-13 MR. EID: I would like to add to Nick that in addition, the data that is generated by the licensee and
~
L 4 then we use, it is really invaluable. The data is so important we do not find it in a published paper or in a
~
5 6 ' journal, and that is we -- after going through the QAQC of 7 the data and we feel confident using the data that they
- 8. have, this will give us one step further in moving towards 3 _using the right thing.
1 10 MR. ORLANDO: Yes, as Boby said, you know, for d 11 xisuspension factors,.really the only study was what -- l 12 that's the66 data, I think? '64 data? 13 MR. EID: The reference we use is '63, '64 data, 14 and we have some skepticism from the beginning about the t () 15 data, how it was used and so on, but because it is the only 16- reliable data -- it was published in the Journal and has 17 lots of data points, so we use references, and we are
.18_ updating this information.
19 DR. WYMER: There is a sort of a sleeper out there 20 with respect to this decontamination and termination of 21- license and restricted license termination that has to do 22- with the potential ultimate role of NRC and what are now 23 DOE's problem. 1 24 You know, if you take over regulation of the DOE ' 25 sites, what thinking have you done with respect to that? i I 1
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L _. !
o 527 1 And'the kind of thing I'm thinking about in particular is 2L when.you look'over the DOE sites and their potential 3 long-range problems, one of the big things you see is
.4 there's a-lot of -- an awful-lot of pump and treat going on J5 forever, essentially, because you never really do get the 6 activity down.
7 Have you done any thinking at all or is it too 8 premature? You've got too much on your plate to even worry 9 about that right now if you do take over the DOE problems? 10 MR. ORLANDO: Well, officially, my understanding 11 is that Secretary Richardson has kind of pulled back from 12 that a little bit. There's not -- 13 DR. WYMER: Yes, but secretaries come and go, you
'14 know?
( 15 MR. ORLANDO: Yes, that's true. Congress has not 16 finally spoken, so I'm not sure where that is going to go. 17 To be honest with you, no, I haven't -- or I don't 18 think we have thought about how we would manage a DOE 19 facility other than if it were to remain, you kno'w, pump and 20 treat forever, then it would remain under some kind of-21 license or some kind of regulatory-control. l' 22 It seems, just off the top of my head,-it would be l 23 relatively easy to impose the restricted use criteria on L 12 4 that facility in a 25 millirem, 100' millirem if there's a -- E25 if_ loss of' control, or a 500 millirem under the alternate
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i l 528 ! 1 -criteria ~. Maybe a DOE facility -- you could never terminate 2- a' license. 3 DR. WYMER: Yes. 4 MRA-ORLANDO: And maybe there wouldn't be -- l 5 again,.just my opinion -- maybe there would not be any 6 utility in ever terminating whatever regulatory hook we have ;
'7 at a DOE facility if it's that badly contaminated, or if !
l 8- they're continuing those-kinds of operations. 9 IHl. WYMER: Yes, but surely you're not turning i
~10' yourEattention to that problem until it becomes your real 11' problem.
12 MR. ORLANDO: Right. Right now, we're just,
.13 again,--trying to -- at least for restricted use, we've I 14 enough. things to do with the fuel cycle facilities and other 15 . folks, q
16- IHl. WYMER: Yes. Okay. 17 MR. NELSON: This is Bob Nelson again. 18 I agree with Nick, we really haven't factored 19 potential of overseeing DOE into this development process, i 20 but. DOE has -- representatives have attended the workshops 1
- 21. and they have commented on various issues as we go through )
22 them. So they have been a participant, and we hope they
- 23. will continue to be a participant in the workshops. I l' 24 So we value their input, but we're not, within the 25- scope of with document, trying to -- looking at it as ANN RILEY & ASSOCIATES, LTD.
O\ Court Reporters
'1025 Connecticut Avenue, NW, Suite 1014 l
i Washington, D.C. 20036 (202) 842-0034 L
E' ) i 529 1 1 ;potentially encompassing DOE sites. ("h
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2 DR. WYMER: Are you; making sure you're not 3- building yourself into a hole? If that does happen -- I 4 don't see anything in it that would indicate that you are 5 constructing a situation that you won't be able to dig out
- 6. of if you do take over the DOE stuff.
7 MR. ORLANDO: I don't think so. I mean, if 8 they're going to'go for unrestricted use, they can -- 9 DR. WYMER: Well, unrestricted, there's no problem 10 with it. 11 MR. ORLANDO: Yes. 12 DR. WYMER: It's the restricted use. 13 DR. GARRICK: At DOE, it's a problem. 14 MR. LARSON: At the last workshop, the DOE guy got I\ V 15 up and said, I don't care what anybody else is using, but 16 we're'using RESRAD. I 17' MR. ORLANDO: That's true. That was a DOE guy, l 1 18 yes. 19 MR. LARSON: One question on the schedule. I 20 :ought to remember it, Nick, but I don't. You're coming back 21- into the committee after you get the public comments and gin ' 22 them up so -- isn't that towards the end of the year? 23 MR. ORLANDO: I believe.so, yes, or we can come 24- back at some other time if you're interested to discuss some 9 's of the issues after you've had a chance to think about them. I I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
P I i 530 1 - I think -- I would have to go back and look at the actual () 2 3-time line that we did. MR. NELSON: I mean, I can't answer it -- We're scheduled to issue or complete 4 the draft modules with the exception of dose modeling in l I 5 June, so if we're no schedule, everything should be done but 6 the dose modeling guidance in June. If you'd want to have a 7 brief in the late -- I don't think you're meeting in August 8 or September, so if you -- if you want to have a briefing in 9 July on the SRP up to that point, we could probably do that, 10 but we would have to look at the specific schedule. But it 11 might be too close to actual completion of the SRP to do 12 that. Maybe the early Fall would be a better time. We'd 13 have completed most of the workshops by that time and could 14 probably -- and would be a lot further along on some of the b(,j 15 dose modeling issues at that point to give you a better l l 16 status report. 17 DR. GARRICK: Any other comments, questions, 18 discussions? I l 19 Thank you for the update. i 20 MR. ORLANDO: Thank you for letting me introduce 21 the people who sat over there who did most of the updating. 22 DR. GARRICK: And I think we'll take our second [ 23 break at this point, and I guess we'll go off the record for l 24 the rest of the day. 25 [Whereupon, at 3:50 p.m., the recorded portion of I \ ANN RILEY & ASSOCIATES, LTD.
\-- Court Reporters 1 ?5 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
g i- ;I 531 1 .the meeting.was concluded.] b
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ANN RILEY'& ASSOCIATES, LTD.
. Court. Reporters
'1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202)'842-0034
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h REPORTER'S CERTIFICATE This is to certify that the attached proceedings before the United States Nuclear Regulatory Commission in
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the matter of: NAME OF PROCEEDING: 108TH ADVISORY COMMITTEE ON NUCLEAR WASTE (ACNW) j CASE NUMBER: PLACE OF. PROCEEDING: Rockville, MD were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and accurate record of the foregoing proceedings.
- k. Og Mark Mahoney Official Reporter Ann Riley & Associates, Ltd.
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4 9 0 . ISSUES REQUIRING RESOLUTION TO DEVELOP A DECOMMISSIONING SRP
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O : i O .
F l O ISSUES - RESTRICTED USE/ ALTERNATE CRITERIA
- 1. How will NRC staff determine whether the licensee has identified ALL of the "affected parties" at a site?
- 2. How will NRC staff determine if the institutional controls proposed by the licensee are j adequate l
- 3. How will NRC evaluate any licensee proposal to terminate the institutional controls, specifically when termination is dependent on the dose at the site decreasing to an l acceptable level
- 4. How will the staff determine if a non-ryulatory entity (community group) has the I authority / ability to enforce institutional controls that are dependent on a regulation (deed restriction)
- 5. DG-4006 indicates that the NRC prefers SSABs. What criteria will the staff use to evaluate compliance with 10 CFR 20.1403(d) other than an SSAB
- 6. What criteria will NRC use to " approve" a local organization's validity as a local l community organization t'%
b 7. How will NRC staff determine whether an institutional control proposed by a licensee is i an " undue burden" on a community
- 8. How will NRC determine if an institutional control is a " durable" institutional control
- 9. What role, if any, will NRC play if conditions necessary to remove institutional controls have been satisfied
- 10. What are the implications of the timeliness rule for Site Specific Advisory Boards (SSABs) acvtivities
- 11. Will NRC want to review the licensee's plan for complying with 10 CFR 1403 (d) before the licensee undertakes these activities
- 12. The regulations do not appear to contemplate situations where a licensee begins decommissioning, intending to pursue unrestricted use, but circumstances dictate that license termination with restricted use is requested
- 13. What authority does a State or local government have to change the restricted use conditions that the licensee was required to meet in order to allow NRC to terminate the l
license Q b l l L
r 1 i I l 0 issues . oose .oostino
- 1. How to develop linkages between the dose modeling module and NUREG -1540 and other regulatory guides
]
' 2. Modeling of alpha-emitters
- 3. Evaluation of DandD screening approach and resolving screening issues
- 4. What other codes are appropriate for for screening
- 5. How to modify parameters in DandD screen and other codes
- 6. Development of default tables
- 7. Determination of how to eliminate dose pathways ;
i
- 8. How to develop the site-specific analysis approach and criteria l 1
- 9. Evaluation of complex modeling of sites g 10. Assessment and comparison of codes and modules V
i 1 l I l l
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l. O ISSUES-ALARA
- 1. ~ is the method in the RegGuide practical for single nuclides, multiple nuclides or multiple sources?
- 2. ' What review methods would apply to other methods ('.e., i multi-criteria, overall options analysis)?
- 3. What level of detail and effort is required for licensees using screening values?
- 4. How do you quantify indeterminate costs and benefits (real estate value, esthetics, noise, avoided costs)?
- 5. ' What is'the appropriate level of management review and action during decommissioning activities.
1 I O I L l: O l
O V ISSUES - H&S PLANS '
- 1. What criteria will the staff use to evaluate a licensee's procedures to reduce the H&S program as the radioactivity and thus the risks posed by the site diminish due to remediation I
o l l m
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ISSUES - SURVEYS
- 1. How to address sampling of volumetricly contaminated materials
- 2. What portions of the Final Status Survey Plan needs to be submitted with the DP and the what are the evaulation procedures / criteria for that partial FSSP. (Note:Under MARSSIM, a complete final status survey plan can't be submitted until after remediation has been completed (e.g., in Class 1 areas) because the post-remediation standard deviation of residual contamination is needed to design the survey).
- 3. How to address large variances in background a
n-I l l
O ISSUES - FINANCIAL ASSURANCE j If a site is terminated under restricted conditions: 1
- 1. How much money should be put aside for financial assurance? UR conventional mills
{ anticipate $2,500 per year in 1978 dollars. An amount (approximately $600,000 today) is set aside when each conventional UR facility is terminated. This amount allows for ] l perpetual visit and inspection and report writing, i
- 2. What activities should be covered or anticipated in calculating the "long-term" funds?
I Should funding be included for activities such as site visits, site inspection, travel, report writing only or should funds for more expensive mitigation efforts be set aside? If so what problems, and what mitigation efforts, should be anticipated? Should funding estimates be based on potential site-specific " failure" scenarios, or a more generic
" failures" approach?
- 3. Should funds be set aside to finance the site into per stuity, or are potential anticipated failure modes limited to a particular time horizon? 1. so, what is that time horizon, and how is it calculated? (e.g., "100 yrs,500 yrs,1000 yrs. l O
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. l 9
,_ ISSUES - MISC
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- 1. It is unclear what decommissioning activities licensees can conduct under their existing licenses
- 2. !!is unclear what documentation is needed for partial site remediation l l
- 3. It is unclear how NRC will evaluate requests for decommissioning under the alternate timeframe provision of the Timeliness rule
- 4. What impact does Section 276 (a) of the Atomic Energy Act have on NRC's implementation of the license termination rule?
- 5. Can a portion of the site be " released" but remain under the licensee's control, and be used for radioactive material management in the future (i.e., remediation and re-use isn't addressed under the rule)
- 6. There is some uncertainty regarding the proper application of the discount rate in conducting ALARA analyses.
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