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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR DISEASE CONTROL

NATIONAL INSTITUTE FOR OCCUPATIONAL

SAFETY AND HEALTH 

+ + + + +

ADVISORY BOARD ON RADIATION AND

WORKER HEALTH 

+ + + + +

WORK GROUP ON SCIENCE ISSUES

+ + + + +

WEDNESDAY

OCTOBER 12, 2011

+ + + + +

 The Work Group convened via 

teleconference at 2:00 p.m., David B. 

Richardson, Chairman, presiding.

PRESENT:

DAVID B. RICHARDSON, Chairman

R. WILLIAM FIELD, Member

GENEVIEVE S. ROESSLER, Member

PAUL L. ZIEMER, Member
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ALSO PRESENT:

TED KATZ, Designated Federal Official

JENNY LIN, HHS

JAMES NETON, DCAS

SUSAN REUTMAN, NIOSH
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C-O-N-T-E-N-T-S 

Discussion of scope of task

for the Work Group......................... 5 

Discussion of priorities and interests

(NIOSH-enumerated list of topics;

other issues)............................. 10

Process for review, discussion,

reporting to Board........................ 17 

Adjournment............................... 54
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1 P-R-O-C-E-E-D-I-N-G-S 

2 (2:03 p.m.)

3 MR. KATZ: Well I would go ahead 

4 and get started. Dr. Richardson, by the way I 

5 sent to you, in response to your question, I 

6 sent you the --

7 CHAIRMAN RICHARDSON: I can see 

8 them, thank you.

9 MR. KATZ: Okay. Very good.

10 CHAIRMAN RICHARDSON: So I 

11 circulated a very brief agenda. And maybe 

12 before starting are there additions to that 

13 that people would like to make? Or revisions?

14 DR. NETON: Yes, this is Jim 

15 Neton. I don't think that we've seen it on 

16 our end.

17 CHAIRMAN RICHARDSON: Okay. I can 

18 tell you, three items on the agenda. One a 

19 discussion of the scope of work for the 

20 Working Group. The second one is a discussion 

21 of priorities and interests. So to go through 
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1 the list of topics and then to give them some 

2 sort of ranking for our attention.

3 And the third one was to discuss 

4 what sort of process we're imagining taking 

5 for review and discussion and reporting back 

6 to the full Board on recommendations.

7 DR. NETON: Great. Thanks.

8 CHAIRMAN RICHARDSON: So the first 

9 issue was the scope of task and I wanted, I 

10 mean partly it was for my own clarification, 

11 and I asked Ted to send me, I had misplaced or 

12 mis-remembered the description that Dr. Melius 

13 had written up describing the responsibilities 

14 for the Work Group.

15 And I tried to pull out what I 

16 thought were the four issues that I thought 

17 were central to it. And I wanted to just to 

18 maybe lay them out and see if there was kind 

19 of agreement, or a kind of consensus that we 

20 understood what this meant, what the Work 

21 Group was being tasked with.
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1 So the first one was --

2 MEMBER ZIEMER: David, this is 

3 Ziemer, did we all get copies of that too or 

4 not?

5 CHAIRMAN RICHARDSON: I don't 

6 know. I didn't remember seeing it previously.

7 MEMBER ZIEMER: I don't recall 

8 seeing it at all. Ted, have we gotten that?

9 MR. KATZ: Nope. So, Paul, you 

10 know I can't recollect exactly how Dr. Melius 

11 distributed it. I think he distributed it to 

12 the Board, but in any event it was put on the 

13 NIOSH website as a Work Group description. 

14 And I can send it to you. To your email.

15 MEMBER ZIEMER: No, that's fine, I 

16 can pick it off the website, I wasn't sure if 

17 we had gotten it separately.

18 CHAIRMAN RICHARDSON: Okay. I can 

19 tell you what I believe are the key points in 

20 it and we can start from there. It looks like 

21 four sentences and I've got four points. One 
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1 of the sentences is relatively long, but it's 

2 just a list.

3 The first issue was that the Work 

4 Group will focus on what I would call disease 

5 risk model issues that are important to the 

6 program. So as distinct from Work Groups that 

7 are focusing on kind of exposure assessment 

8 issues.

9 The way that this group was tasked 

10 was to focus on those issues that relate to 

11 models for disease risks and how they've been 

12 incorporated into IREP and into the program, 

13 which I think was kind of useful for me 

14 because some of the scientific issues that 

15 NIOSH has identified relate to kind of 

16 exposure assessment issues.

17 The second one was the Work Group 

18 will review the current status of each 

19 scientific issue that has been identified by 

20 NIOSH in their status updates. So these 

21 include incorporation of epidemiologic studies 
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1 from nuclear workers. Questions regarding 

2 dose and dose rate effectiveness.

3 Questions regarding interactions 

4 between other agents, including smoking and 

5 other occupational hazards in radiation. Age 

6 at exposure and grouping of rare and 

7 miscellaneous cancers.

8 The third point is how the 

9 description ends is, "The Work Group may 

10 identify new science issues that may impact on 

11 disease risk models." So here the scope 

12 includes, I believe, the description is to 

13 include those issues that have been previously 

14 identified and then to be able to, if 

15 necessary, add new items to the list.

16 And then lastly, the Work Group 

17 will assess each issue and report back to the 

18 Board. And that gets to, I think, what I 

19 think would be useful for us to have a 

20 discussion about that's the process for what 

21 we mean by an assessment of an issue.
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1 So that, for me, was I think the 

2 first issue on the agenda was do we 

3 understand, as a Work Group, do we have 

4 consensus on what's meant by the scope of the 

5 task of work and do we have any feedback we 

6 want to give on that?

7 MEMBER ZIEMER: Okay. So you're 

8 looking for comments, David?

9 CHAIRMAN RICHARDSON: Yes.

10 MEMBER ZIEMER: Well let me start, 

11 this is Ziemer. I think the things that have 

12 been identified here certainly are in keeping 

13 with the discussion that we had as a full 

14 Board when this Work Group was suggested.

15 Also if we were to find, as we 

16 move forward, that there's some additional 

17 issue or sort of additional scope item that we 

18 should be addressing we can always suggest 

19 that the overall scope of the Work Group be 

20 modified.

21 So I don't we're necessarily, our 
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1 hands are tied or locked in by saying let's go 

2 with these four. I think these four make 

3 sense and I think it's a good place to start.

4 CHAIRMAN RICHARDSON: Okay. Are 

5 there other comments that other people who 

6 feel like this is reflecting what the 

7 discussion was?

8 MEMBER FIELD: Yes, this is Bill 

9 Field. I agree completely with Paul. I think 

10 this is a good place to start. And if we need 

11 to expand it we can do that at a later date.

12 MEMBER ROESSLER: Yes, this is Gen 

13 Roessler. I just joined in a bit ago. Right 

14 now I'm just listening, I'm between flights in 

15 Atlanta and I'm going to try and join in on 

16 the teleconference as much as I can.

17 CHAIRMAN RICHARDSON: Okay. Good. 

18 Well I will say I went through the transcript 

19 where the discussion about forming a 

20 Scientific Work Group was formed.

21 And I feel like it does conform 
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1 pretty well to the discussion. I think some 

2 of the things are made a little bit more 

3 explicit here about what we're talking about.

4 But I agree it's a good starting 

5 point. So if that's agreed then we would sort 

6 of take that as the key principles of the kind 

7 of, at least for now, the terrain that we 

8 would be moving through.

9 The next thing was to talk about a 

10 discussion of priorities and interests within 

11 the scope of work. So there are a number of 

12 issues listed and there's the potential to 

13 include other issues on the list.

14 And it seemed to me like these, 

15 given our resources and our time and the 

16 complexity of the problems, we probably want 

17 to make some priorities and not try and tackle 

18 all of these simultaneously.

19 And so going through the list of 

20 topics I thought we might make a pecking order 

21 and then I would open up discussion about 
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1 whether we want to focus on a single issue or 

2 maybe at most two issues simultaneously and 

3 not too much more that.

4 So there's incorporation of 

5 information, I guess I would call it 

6 information that's external to the life span 

7 study and to the risk models. Dose and dose 

8 rate effectiveness factor. Grouping of 

9 cancers. Age and exposure. And interaction 

10 with other workplace exposures.

11 So we have some, we've been tasked 

12 with at least thinking about each of these 

13 items as a starting point. And how we'd like 

14 to do that. So are there suggestions?

15 MEMBER ZIEMER: I guess I'd like 

16 to hear from NIOSH as to sort of maybe where 

17 we are on some of these. I know NIOSH has 

18 some studies going on that may sort of flesh 

19 out some of these and perhaps we can, maybe 

20 Jim Neton could give us an idea of where we 

21 are on some of these.
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1 What's NIOSH doing? You sort of 

2 talked about some of this at the meeting, Jim, 

3 I know. But I think it's probably worth sort 

4 of revisiting that and renewing our memories 

5 on that.

6 DR. NETON: Yes. Sure. This is 

7 Jim Neton. Most of these have been fairly 

8 static to be honest with you. We have been 

9 primarily involved in the collection and, you 

10 know, assimilation and review of literature as 

11 it emerges, the scientific literature.

12 The one area where we do have a 

13 fair amount of work, the SENES, our 

14 contractor, has produced is in the dose and 

15 does rate effectiveness factor area.

16 They've put together a draft, 200 

17 plus page review, of all the current 

18 literature on DDREF. And it's actually out 

19 for review by, I believe it's part of an ICRP 

20 committee that has it for sort of a stepping 

21 stone for a document that they're putting 
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1 together. So that does exist in draft form.

2 We did start an initial attempt at 

3 grouping of some rare and miscellaneous 

4 cancers. And in particular we were looking at 

5 possibly pulling out the prostate cancers from 

6 the what's now called, I forget the name of 

7 it, it's All Male Genitalia, I think is what 

8 it's called, or something like that.

9 It was an analysis done some time 

10 ago, I would have to dig it out, which 

11 indicated that actually the risk model for 

12 prostate cancer might go down if we did that. 

13 And we never really completed that effort.

14 In the area of age of exposure, 

15 interaction of other workplace exposures, 

16 again, just mostly a compilation of 

17 literature. The corporation nuclear worker 

18 epi studies DSHEFS, another division within 

19 NIOSH, still has a little bit of an active 

20 program in that area.

21 And Doug Daniels along with Mary 
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1 Schubauer-Berigan and others have recently 

2 published a meta-analysis of a numbers of 

3 sites. I believe it was like 25 sites or 

4 something like that. A meta-analysis of a 

5 risk model for leukemia among specifically 

6 targeted occupational cohorts.

7 And that was published and my 

8 recollection is the risk factor they derived 

9 was fairly consistent with what's been 

10 determined from the Hiroshima/Nagasaki 

11 studies. And that's about the extent of it 

12 right now.

13 CHAIRMAN RICHARDSON: Okay. Well 

14 it's useful to know. So the topic that you 

15 feel like is most advanced right now, in the 

16 work you've done, relates to DDREF. And so 

17 one option for us is to start with something 

18 that you feel like you have something that we 

19 could engage with.

20 Is that report at a point that 

21 this Work Group could read the draft, or would 
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1 you ask that we work in parallel to you as 

2 opposed to in response?

3 DR. NETON: Yes. No, I believe 

4 that the draft is in reasonable form where it 

5 could be reviewed. It's missing, 

6 interestingly, the conclusion section. 

7 Because, you know, what one makes of this body 

8 of knowledge has been the biggest conundrum 

9 for us.

10 I mean there's a lot of data out 

11 there. A compilation of animal studies, epi 

12 studies and others that one can look at. And 

13 then to determine whether the current DDREF 

14 that's used in IREP is sufficient or it needs 

15 to be modified based on that knowledge. It's 

16 still up in the air, but all the literature is 

17 there, so it's available.

18 MEMBER ZIEMER: David, this is 

19 Ziemer again. And I think we don't have any 

20 sort of responsibility to help any of these 

21 things come to conclusion in the scientific 
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1 sense, I don't think.

2 As I understand it what we would 

3 do as a Work Group would be to assess where 

4 things are and report to the Board. So it 

5 seems to me it would be worth looking at, for 

6 example, that study.

7 And even if they're at the point 

8 where they've reviewed the literature and so 

9 on and haven't been able to sort of close it 

10 out, I think that's the kind of information 

11 the Board needs. It certainly wouldn't be up 

12 to us to sort of reach the conclusions as I 

13 understand it.

14 And let me make one other comment, 

15 if I might. On the sort of list. The 

16 interaction with other workplace exposure, it 

17 seems to me is one which would be low priority 

18 for us.

19 In part because I don't think that 

20 our Board has any responsibility for that 

21 under the legal framework that we're working 
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1 on. We look only at the radiation. I mean 

2 that's certainly an important area.

3 But until the law develops a sort 

4 of an acceptable way of addressing multiple 

5 exposures like that. And part B, I don't know 

6 that we would have any responsibility. Just a 

7 kind of reaction though, maybe others don't 

8 agree wit that.

9 CHAIRMAN RICHARDSON: No, I agree 

10 with you concerning the first point that, I 

11 mean this will get I guess to the last point 

12 on the agenda eventually of what's the process 

13 for review and what's to be reported.

14 But my sort of understanding was 

15 identifying needs or gaps that might stimulate 

16 some future work to move forward. It's not to 

17 propose a distribution, for example, for a 

18 parameter in IREP.

19 MEMBER ZIEMER: Right.

20 CHAIRMAN RICHARDSON: And so 

21 working through topics where we think that 
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1 there's kind of relevant recent research would 

2 make sense to me as a starting point.

3 The question of the interactions, 

4 I think there are some points of IREP do 

5 involve models, for example, of radiation and 

6 smoking. Where the radiation risk --

7 MEMBER ZIEMER: That is covered, 

8 you're correct. Right.

9 CHAIRMAN RICHARDSON: And so that 

10 would be, I guess, and example of where --

11 MEMBER ZIEMER: Yes, I was 

12 thinking more about chemical exposures. And 

13 in fact we certainly would be in a position to 

14 say this is an area that needs greater study.

15 I mean the chemical and radiation, 

16 I think we all sort of know, at least 

17 intuitively, that there is likely to be such 

18 interactions.

19 And that going forward it would be 

20 useful to know and have a scientific basis on 

21 which to evaluate that. But beyond that I'm 
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1 not sure what we would do.

2 CHAIRMAN RICHARDSON: Right.

3 DR. NETON: David, this is Jim 

4 Neton. I just thought of one more thing I 

5 might throw out on the table, if I may. One 

6 thing that we have been struggling with 

7 internally is what might be able to be done 

8 with the data that we actually collect on 

9 these workers in-house.

10 You know we have over 30,000 cases 

11 and right now we don't do any research with 

12 the cases. But is always seemed to us that 

13 there might be possibilities for doing some 

14 sort of research in this area using these 

15 cases in particular.

16 It would have to undergo IRB 

17 review and everything if we were to proceed 

18 down that path. But, you know, if the Working 

19 Group had any insight or ideas in that area it 

20 would certainly be welcomed by us.

21 CHAIRMAN RICHARDSON: Well that's 
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1 definitely an interesting topic.

2 MEMBER ZIEMER: I think that's a 

3 great idea. You guys have gathered so much 

4 information over the last decade. We probably 

5 have a wealth of data that could be mined by 

6 someone, maybe even on this.

7 Jim, I don't know if you were 

8 talking the interaction with other exposures, 

9 but we certainly have information that people 

10 have given us about those things.

11 Maybe someone could mine that. 

12 You know, some group would have to fund it and 

13 so on. But I think we could make 

14 recommendations of that type. You know, how 

15 can all the data that have been gathered be 

16 used for other related scientific studies? A 

17 great notion.

18 DR. NETON: Right. You know we 

19 have like a brief smoking history on all lung 

20 cancers at least. And we have a tremendous 

21 amount of monitoring data, particularly the 
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1 external data, for all workers that we've gone 

2 and retrieved the best amount of information 

3 out there.

4 Internal, bioassay data, it's all 

5 there. The only problem is one can recognize 

6 this as somewhat of a biased population that 

7 we have. But if one can work around those 

8 issues it seems to me that there might be some 

9 valuable research that could be done.

10 CHAIRMAN RICHARDSON: There's 

11 potentially several ways that that could be 

12 useful. I mean it could be useful in its own 

13 right and it could be useful for strengthening 

14 some of the other topics that the group has 

15 been tasked with.

16 Like incorporation of the nuclear 

17 worker cohort study information if there's 

18 questions about the confounding by smoking or 

19 questions about healthy worker effects, or 

20 selection effects.

21 That some of the data that you 
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1 have in-house could either resolve or account 

2 for those sort of potential biases in the 

3 worker data. So that could also be useful in 

4 that way.

5 In terms of the priorities, in 

6 addition to the enumerated list, one topic 

7 that I know that's out there that's not on 

8 the list, but I know it's under discussion by 

9 NCRP and maybe by other organizations.

10 EPA I think also, is questions 

11 regarding relative biological effectiveness 

12 and kind of the assumptions that are made in 

13 the current disease risk models and whether 

14 those are supported by the contemporary 

15 literature.

16 And so there's, you know, 

17 potentially a review that's as extensive as 

18 the review of DDREF that would be on kind of 

19 toxicological and mechanistic and what little 

20 epidemiologic evidence there is concerning the 

21 RBE for exposures to tritium or neutrons and 
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1 the other components.

2 And I guess I would propose 

3 considering that at some point on the list of 

4 issues. I think SENES has been involved in 

5 the review of that topic as well.

6 DR. NETON: Are you talking about 

7 the RBE for neutrons and tritium and stuff?

8 CHAIRMAN RICHARDSON: Yes, low 

9 energy photons.

10 DR. NETON: Actually that's sort 

11 of been done originally by SENES when we first 

12 put the program together. We were the first 

13 ones, at least to my recollection, to propose 

14 an increased RBE for photons below a certain 

15 energy. I believe 100 keV. And likewise for 

16 low energy betas, which would include tritium.

17 So yes we've done some of that. 

18 The study that SENES has recently done is an 

19 update on all of that information. Although 

20 I'm not sure much has changed in the area of 

21 the RBE to the lowering of photons.
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1 But I found that to be a very 

2 fascinating piece of research that was done. 

3 Because it's not considered in any of the 

4 regulatory standards, at least in the United 

5 States these days. And it seems to be real.

6 CHAIRMAN RICHARDSON: So I would 

7 imagine, or I would suggest that that might be 

8 a type of topic that also at least would be 

9 worth having a review by the Work Group and 

10 reporting back to the Board with the status of 

11 those assumptions regarding RBEs.

12 MEMBER ZIEMER: I concur with 

13 that. I think that's a good suggestion. This 

14 is Ziemer again.

15 CHAIRMAN RICHARDSON: In terms of 

16 resources do you think that we have the, we 

17 would like to move through these one at a time 

18 or more than one at a time? I think I would 

19 lean probably towards one or no more than two 

20 topics at a time just to allow us to have an 

21 informed discussion of this.
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1 MEMBER ZIEMER: You mean on those 

2 individual topics, like dose and dose rate 

3 effectiveness --

4 CHAIRMAN RICHARDSON: Right.

5 MEMBER ZIEMER: And when you're 

6 talking about resources you're just talking 

7 about the time and effort for the Work Group?

8 CHAIRMAN RICHARDSON: Yes.

9 MEMBER ZIEMER: Yes. That would 

10 make sense I think. I don't know, what do you 

11 think, Bill?

12 MEMBER FIELD: Yes I think one at 

13 a time. It seems like in, you know, 

14 stratifying the ones to look at first, maybe 

15 the ones to look at first would be the ones 

16 that any decision or maybe long-term outcomes 

17 that would be created because of our review, 

18 it seems like there should be some 

19 consideration put into how many worker's dose 

20 reconstructions may be affected by that.

21 So I guess it's the potential 
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1 impact on that. And, Jim, I had a question. 

2 You have mentioned that there is a 

3 questionnaire for smoking for lung cancer, is 

4 that right?

5 DR. NETON: Yes.

6 MEMBER FIELD: Okay. Is it just 

7 for lung cancer where the PoC will be adjusted 

8 based on smoking history?

9 DR. NETON: Lung cancer and I 

10 think cancer of the bronchus.

11 MEMBER FIELD: Okay. But those 

12 are the only two and there's --

13 DR. NETON: Yes, respiratory.

14 MEMBER FIELD: Yes, I'm just 

15 wondering what was the, well I understand the 

16 basis for it since 85 percent of lung cancers 

17 are caused by smoking, but there's other 

18 smoking related cancers as well.

19 And I'm just wondering were they 

20 ever considered that they should be adjusted. 

21 Or I guess who made the decision that it 
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1 should be adjusted because of smoking.

2 As there's other lifestyle factors 

3 that you could argue that you could adjust the 

4 PoC for based on, you know, things like 

5 obesity or, you know, there seems to be a fine 

6 line there drawn.

7 DR. NETON: Yes, well the decision 

8 was made after looking at all the literature, 

9 Mary Schubauer-Berigan worked on this pretty 

10 extensively in the beginning, that the only 

11 data that were of sufficient quality to make 

12 that adjustment were the lung cancer and 

13 smoking adjustments.

14 She did look at other organs and 

15 there were some data out there to suggest that 

16 other cancers could be related to smoking. 

17 But at least at the time that this was put 

18 together, over ten years ago now, we didn't 

19 feel that there was enough evidence to make a 

20 good quantitative model from it.

21 MEMBER FIELD: I guess myself, I 
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1 know Dick Lemen brought this up before. I 

2 think this is a whole area that would be worth 

3 looking at. Adjustment of the PoC based on 

4 other risks. And it may not be chemical, but 

5 it could be just lifestyle factors.

6 DR. NETON: Yes.

7 MEMBER ZIEMER: The approach on 

8 that to see what's in the literature and as to 

9 whether or not we think it's sufficiently 

10 mature for somebody to take a hard look at it 

11 or what would --

12 MEMBER FIELD: Well, I guess I'm 

13 just looking at it from the scientific 

14 justification. Because we know these other 

15 cancers that are affected by smoking or you 

16 have an increased risk due to smoking.

17 You know, when you do epidemiology 

18 studies you always look to see if you have 

19 this certain one that's increased. Not just 

20 the pharynx or the larynx, you look at several 

21 different cancers that may be associated with 
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1 it.

2 And I guess the rationale, or the 

3 justification, for adjusting it for one but 

4 not others, and I think what Dick was arguing 

5 that it shouldn't be adjusted for lung cancer 

6 at all.

7 Why is it just adjusted for one 

8 when we know it's associated with others and 

9 those aren't adjusted. I guess it's there you 

10 go with the way the attributable risk due to 

11 smoking. But I guess it's just the whole case 

12 that is made that you, at just smoking, that 

13 you adjust the PoC for lung cancer because 

14 they smoke.

15 But yet there's many other 

16 lifestyle factors that affect our, I guess not 

17 ability, but the propensity to develop cancer 

18 that we're not looking at.

19 And I'm wondering when this was 

20 all written up what was the justification for 

21 saying we're going to pick this one lifestyle 
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1 factor out and we're going to ignore the 

2 others. And I was just trying to figure out 

3 if there was a historic basis where this was 

4 considered.

5 And my guess is it was considered 

6 because the attributable risk is so great from 

7 smoking that you had to build in some factor. 

8 But I think, based on my conversations with 

9 Dick and other people, this is an issue that's 

10 going to come up.

11 CHAIRMAN RICHARDSON: Yes, well I 

12 think it's certainly a topic that would 

13 probably be useful for us to look at and 

14 understand a little bit more regarding the 

15 methods that have been used. You know, right 

16 now what they've done, it's sort of, as Jim 

17 said, Mary made a case that there was perhaps 

18 enough evidence.

19 It wasn't so much that smoking was 

20 a strong cause of lung cancer and there was 

21 less evidence that smoking was a cause of 
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1 other types of cancers.

2 Because I think that that's been, 

3 I mean a list of smoking associated cancers 

4 has been on the table since the 80s and 

5 probably not long after the Surgeon General's 

6 report.

7 But it was that she thought there 

8 was enough evidence regarding kind of the 

9 question of whether smoking and radiation 

10 interacted in a multiplicative scale or an 

11 additive scale.

12 And then there was a critique that 

13 came forward on IREP and I wrote one of the 

14 critiques and several other people wrote 

15 comments about the evidence was really fairly 

16 ambiguous about whether these joint effects 

17 were additive or multiplicative.

18 And the data were too sparse in 

19 the life span study, for example, to try and 

20 understand how those joint effects were 

21 happening and whether, which model fitted the 
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1 data better.

2 So there's right now IREP has got 

3 this hybrid where they fit an additive model 

4 for the two effects and a multiplicative model 

5 and I think they average them.

6 And if that's the resolution to 

7 that then you're right you could also fit 

8 additive and multiplicative models for other 

9 disease risk factors.

10 Or for smoking and its effects on 

11 lots of other cancer sites, if you were so 

12 motivated. And --

13 MEMBER ZIEMER: Well, David, was 

14 Mary, or maybe Jim can answer. Was Mary 

15 saying that the interaction for radiation and 

16 smoking for lung cancer that the data were 

17 more robust than for the other organs where 

18 you might have interaction between radiation 

19 and smoking?

20 DR. NETON: Yes.

21 MEMBER ZIEMER: Was that the 
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1 issue?

2 CHAIRMAN RICHARDSON: Yes.

3 DR. NETON: Yes. That's true, Dr. 

4 Ziemer, that the data were better for smoking 

5 and lung cancer, obviously. And my 

6 recollection was, I think this might be 

7 documented in the technical basis for the IREP 

8 model on our website. 

9 MEMBER ZIEMER: If that's the case 

10 maybe one should ask the question whether or 

11 not that's still situation. Maybe there, I 

12 mean, that's been a decade ago I guess.

13 CHAIRMAN RICHARDSON: Right.

14 DR. NETON: Right, that's true.

15 MEMBER ZIEMER: So maybe only to 

16 revisit it, or at least to revisit it in terms 

17 of saying do we have more robust data for 

18 either other organs, well I guess other 

19 organs. Ted, as a starting point we'd be 

20 talking smoking, whether we get into obesity 

21 or something that's a whole -- another ball 
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1 game too.

2 CHAIRMAN RICHARDSON: Yes, and in 

3 fact in the last couple of years there was 

4 substantially more work on the relationship 

5 between smoking and radiation in the A-Bomb 

6 survivors too.

7 They went back and did a lot more 

8 linkage work with what they call the Adult 

9 Health Survey in the cancer incidence data. 

10 So that's been remodeled as well. I mean 

11 there probably is maybe time to look at that 

12 assumption.

13 MEMBER ZIEMER: It might be worth 

14 revisiting that at least.

15 DR. NETON: Well we actually did 

16 go back. And maybe this was before, David, 

17 your time on the Board. Went back and 

18 modified our smoking adjustment for lung 

19 cancer based on the Pierce re-analysis that 

20 was published.

21 And at that time what we ended up 
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1 doing was including both Pierce and the 

2 original analysis and picked the higher 

3 Probability of Causation for the results.

4 And we did indicate at that time 

5 that as the data became clearer we might drop 

6 the original one if it seemed to us to be 

7 reasonable. We haven't gone back an looked at 

8 that since then. One thing I'd also --

9 MEMBER FIELD: Yes, I think it 

10 would be very interesting to go back and look 

11 at that. And I'd be really interested to see 

12 what information is collected to quantify 

13 smoking history.

14 Because there's so much to these 

15 interactions are based on total pack years and 

16 pack-year rate can be important. Year, date 

17 first started smoking. So it'd be very 

18 interesting to see can be captured in the 

19 questionnaire and if that's what's being used.

20 DR. NETON: The questionnaires are 

21 very rough. I don't think there's anything 
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1 such as a pack-year calculation. It's really 

2 more have you smoked and how many packs per 

3 day.

4 And I think if you quit smoking 

5 within the last five years. I've forgotten. 

6 I'd have to go back and look at the form but 

7 it's pretty basic.

8 One thing I just want to point 

9 out. I looked up the original Act. And when 

10 the Act speaks of NIOSH producing guidelines 

11 for Probability of Causation there's a Section 

12 3C that says that we should take into 

13 consideration type of cancer, past health 

14 related activities, such as smoking, and other 

15 information on the risk of developing a 

16 radiation related cancer from workplace 

17 exposures and other relevant factors.

18 So that really is in the Act 

19 itself.

20 MEMBER ZIEMER: So it opens the 

21 door for anything that we think might be 
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1 relevant?

2 DR. NETON: It does. And it 

3 specifically calls out smoking in their 

4 language, so one of the reasons I think also 

5 we focused on that. And that was doable at 

6 that time.

7 MS. LIN: Sure. But I just want 

8 to point out the regulations sort of pin down 

9 exactly the type of personal and medical 

10 information that you should use to determine 

11 the Probability of Causation and in Section A 

12 1.5(f) you should see smoking history if the 

13 claim is for lung cancer or a secondary cancer 

14 for which lung cancer is a likely primary 

15 cancer.

16 And it stops there instead of 

17 saying all the other factors, X, Y and Z. So 

18 within the regs you have a very specific list.

19 MEMBER ZIEMER: Yes.

20 DR. NETON: There's no doubt that 

21 we would have to, if we were to develop 
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1 quantitative models for other factors, the 

2 regulation would need to be changed.

3 MS. LIN: Right. And obviously 

4 we'll talk about it when we get there.

5 DR. NETON: Yes. In the preamble 

6 I think we said as much. That there were no 

7 quantitative models we can develop at this 

8 time but we would continue to look at them and 

9 evaluate them as the science emerged.

10 MS. LIN: Yes.

11 DR. NETON: That's true.

12 CHAIRMAN RICHARDSON: Jim, could I 

13 ask for one clarification? You had talked 

14 about the work on RBE, is that that SENES has 

15 done for you, is that wrapped within that 200 

16 page draft report on DDREF?

17 DR. NETON: No. No, it's not. I 

18 might have misspoke when I was speaking of 

19 that. No, the RBE work was actually published 

20 in the Health Physics Journal shortly after it 

21 was incorporated into IREP. It went out there 
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1 in the peer review literature.

2 CHAIRMAN RICHARDSON: Right. And 

3 you know the UK NRPB has put out a report on 

4 RBE and I think the Canadian, whatever they 

5 call themselves, Radiation Protection 

6 Organization also has done something. At 

7 least for like tritium and low energy photons. 

8 Something like that.

9 DR. NETON: Right.

10 CHAIRMAN RICHARDSON: So there 

11 would be several reports that might be useful 

12 to review that have come out in the last 18 

13 months or two years.

14 DR. NETON: Yes. Agreed.

15 CHAIRMAN RICHARDSON: So I could 

16 propose a pecking order and then we could 

17 start shuffling. Maybe to start with the 

18 DDREF and then move on to RBE. And then maybe 

19 adjustment of the Probability of the Causation 

20 for other factors, such as smoking.

21 And then look at age at exposure. 
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1 The incorporation of nuclear worker studies. 

2 And end with grouping of rare and 

3 miscellaneous cancers. Oh and we also have 

4 the issue of the use of data in-house. We 

5 should have that on the list.

6 MEMBER ZIEMER: Can you repeat 

7 those, David? So it's DDREF?

8 CHAIRMAN RICHARDSON: And then 

9 RBE, and both of those I think we'll be able 

10 to start by kind of a review of existing 

11 documents.

12 MEMBER ZIEMER: Right.

13 CHAIRMAN RICHARDSON: And then the 

14 issue that we were just recently discussing, 

15 the adjustment of the PoC for other factors 

16 that are risk factors for the disease that the 

17 claim is.

18 And then age at exposure. And 

19 then incorporation of nuclear worker studies. 

20 And then the last two. Grouping of rare and 

21 miscellaneous cancers and use of data in-
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1 house.

2 MEMBER ZIEMER: I'm okay with 

3 that.

4 MEMBER FIELD: Yes, David, this is 

5 Bill. I think that's a reasonable order.

6 CHAIRMAN RICHARDSON: Okay. Now 

7 if that's agreeable that would keep us busy 

8 for some time.

9 MEMBER ZIEMER: Yes.

10 CHAIRMAN RICHARDSON: In terms of 

11 what the deliverable is, in terms of each 

12 review and the sort of process that we might 

13 take. As I understood it in the notes I took 

14 from the discussion it was to assess the issue 

15 where possible.

16 Evaluate what needs to be done to 

17 address the question with the hope that we 

18 might stimulate additional work, if necessary 

19 to move forward on the issue, as it relates to 

20 the risk models used by the program.

21 And if there are considerations 
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1 that impact on timeliness or scientific 

2 validity to kind of raise those and point 

3 those out to the Board. And so if that sort 

4 of the objective of the review the question is 

5 how do we do that.

6 I assume what we would do is break 

7 into some sort of group where one person takes 

8 maybe primary lead for writing a first draft 

9 of a review, document based on the information 

10 that we pull together.

11 We rely on the rest of the Board 

12 to help identify relevant literature. Then we 

13 circulate that draft and we begin working 

14 together to think about what the aims of kind 

15 of a short report would be on the topic.

16 And I'm imagining sort of a 

17 deliverable that's probably not very long. So 

18 it wouldn't end up being another 200 page 

19 document based on a review of a 200 page 

20 document.

21 But maybe more like a two-page 
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1 document. Does that sort of sound like a 

2 reasonable idea for what the review would be?

3 MEMBER ZIEMER: That certainly 

4 makes sense to me. In other words we would 

5 tell what we did and what our recommendation 

6 is?

7 CHAIRMAN RICHARDSON: Right.

8 MEMBER ZIEMER: Is that right? 

9 And basically these are reports to the Board?

10 CHAIRMAN RICHARDSON: Yes.

11 MEMBER ZIEMER: And then if there 

12 was implications beyond that it would be up to 

13 the Board to pick up the ball and carry 

14 something forward or, you know, if they're 

15 going to recommend somehow that the 

16 legislation needs to be modified that would 

17 have to be handled by the Board.

18 CHAIRMAN RICHARDSON: Right.

19 MEMBER FIELD: That sounds good, 

20 David.

21 MR. KATZ: This is Ted. I just 
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1 wanted to respond a little bit to what Paul 

2 just said about legislation. I mean I think 

3 the aim here is the regulations were set up 

4 with the anticipation that science would 

5 continue moving forward.

6 And that more could be done down 

7 the road on this front, specifically as well 

8 as others. And so I think the aim for the 

9 Board, as entire, is as this work develops to 

10 be able to make recommendations, give guidance 

11 to NIOSH about changes that it can make on any 

12 of these factors.

13 And it sounds like the timing's 

14 pretty good. It sounds like NIOSH has done 

15 quite a bit of work and it's getting close to 

16 at least producing sort of a evaluative works, 

17 on this first topic at least. But so, again, 

18 the Board is here to give guidance and advice 

19 on this topic.

20 But I don't anticipate that this 

21 really, that you'd need statutory changes. 
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1 And Jim gave an example where you might need a 

2 regulatory change to implement something.

3 But I think what you're aiming to 

4 do is give guidance to NIOSH where the Board 

5 believes it can move forward. That there is 

6 enough science, enough water under the bridge, 

7 to make a change.

8 MEMBER ZIEMER: Ted, I was really 

9 only referring to the remark that Jenny made 

10 that the legislation, well I guess both you 

11 and Jenny had talked about what the 

12 legislation said, and the comment that if you 

13 were going to go beyond that there would have 

14 to be a modification.

15 And of course that would have to 

16 generate with NIOSH, not with the Board. The 

17 Board --

18 MR. KATZ: I understand, Paul. I 

19 think Jenny was talking about the regulation 

20 not the legislation. But it's just --

21 MEMBER ZIEMER: Well that's what I 
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1 meant, yes.

2 MR. KATZ: Okay. I'm probably 

3 splitting hairs with you.

4 MEMBER ZIEMER: Yes, right. No, 

5 that's what I intended to address was that 

6 comment.

7 MR. KATZ: Okay.

8 CHAIRMAN RICHARDSON: Okay. So as 

9 we start on this, well choosing, Jim, would 

10 you be willing to share with us the document 

11 that SENES Oak Ridge has produced on DDREF and 

12 circulate that to the Work Group? With the 

13 understanding that it's a draft.

14 DR. NETON: Yes. Provided a draft 

15 not for circulation, that sort of all the 

16 provisos and such. But, yes.

17 CHAIRMAN RICHARDSON: Of course. 

18 And I think it would be, well I hope for your 

19 purposes it's useful to receive our comments 

20 on them. I think it's terrific if an 

21 organization like ICRP is looking at it as 
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1 well. I'd imagine that we'll bring a 

2 different perspective to it that ICRP would.

3 DR. NETON: Oh yes.

4 CHAIRMAN RICHARDSON: In the sense 

5 of the difference between thinking about DDREF 

6 in terms of radiation protection versus the 

7 framework here of compensation, which really 

8 may recast thinking on some issues. But, you 

9 know, there's certainly an overlap between 

10 them. But it could be that --

11 DR. NETON: Right and there's one 

12 other thing. I think Bill Field, Bill 

13 mentioned an interesting point to me, which is 

14 which of these parameters are going to have 

15 the biggest effect on the dose 

16 reconstructions.

17 And, you know, I've not done this 

18 but it always seemed to me that DDREF would be 

19 a fairly insensitive change in the final 

20 outcome of the dose reconstruction.

21 Partly because how we default to 
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1 an acute exposure, unless we know otherwise. 

2 But you know there's a lot of conservatism 

3 built in to our calculations, so I'm not sure 

4 how much the DDREF really kicks in in many of 

5 these dose reconstructions.

6 That's something we might think 

7 about as we look through this paper and review 

8 the literature and such.

9 CHAIRMAN RICHARDSON: Okay. Yes, 

10 it's useful. And maybe you can remind us of 

11 that again.

12 DR. NETON: Yes, I will. And it's 

13 almost, you know, I'm not trying to make more 

14 work for myself. But one might want to do a 

15 sensitivity analysis and see how much change 

16 would result in --

17 Essentially what I think if you 

18 look at the literature, and I don't want to 

19 prejudge this, but it would be sort of 

20 tweaking the central tendency on the DDREF and 

21 maybe looking at the spread, the range a 
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1 little bit.

2 And I don't think we can justify a 

3 huge change at this point. But anyway, I've 

4 said enough on that. I don't want to bias you 

5 guys.

6 CHAIRMAN RICHARDSON: In terms of 

7 writing is there somebody who's chomping at 

8 the bit to take a lead on draft of a first 

9 document on this first topic? If not, facing 

10 a lot of silence --

11 MEMBER ZIEMER: Nobody's chomping 

12 at the bit.

13 CHAIRMAN RICHARDSON: I'd be 

14 willing to write something that's rough as a 

15 starting point for us to discuss.

16 MEMBER ZIEMER: Sure.

17 CHAIRMAN RICHARDSON: And I think 

18 we'll, if this is actually 200 pages, we'll 

19 need more than a week or two in order for me 

20 to do that. But --

21 MEMBER ZIEMER: Well there's not a 
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1 big urgency on that in terms of a time table 

2 is there? I mean --

3 CHAIRMAN RICHARDSON: I don't 

4 think so, no.

5 MEMBER ZIEMER: I mean I assume 

6 that, for example, at our next regular meeting 

7 you would simply report that the Work Group 

8 has gotten underway and that we're looking, 

9 for example, at that particular issue.

10 CHAIRMAN RICHARDSON: Right.

11 MEMBER ZIEMER: And then at some 

12 point down the line, when we're done doing 

13 that, we'd have the report.

14 CHAIRMAN RICHARDSON: Good.

15 MEMBER ZIEMER: Does the Board 

16 have to approve the scope, or has that 

17 already, or the scope of the Work Group?

18 CHAIRMAN RICHARDSON: Ted, I think 

19 --

20 MR. KATZ: This is Ted. I think 

21 it's approved. I don't remember the process 
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1 but I believe Jim let out that statement that 

2 is now on the web. And everything that you've 

3 talked about fits within it.

4 MEMBER ZIEMER: Right.

5 MR. KATZ: So there's nothing 

6 changed here. I think you're good in terms of 

7 you have your task already. As far as the 

8 Board entirely is concerned, there's nothing 

9 more to do there I don't think.

10 MEMBER ZIEMER: And we've agreed 

11 to follow that and we've agreed on the order 

12 in which we'll address these issues. And 

13 we're going to get underway with the first 

14 one. And when we're done we'll report, right?

15 MR. KATZ: Right. That makes good 

16 sense to me.

17 CHAIRMAN RICHARDSON: I think that 

18 sounds good. I think the question that Jim 

19 posed of kind of the sensitivity of different 

20 hypothetical claims to DDREF, I think is maybe 

21 an interesting one also to bring forward to 
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1 the Board.

2 I don't know if we would want to 

3 return that to you, Jim, as something down the 

4 line, not thinking this in the near term, or 

5 whether we have other resources for kind of 

6 exploring those sorts of questions.

7 But that's the sort of thing that 

8 I think would have to, it would involve 

9 somebody using the IREP program under 

10 different scenarios.

11 DR. NETON: Yes, that could just 

12 be a recommendation of the Board. I mean, it 

13 might ought to be done. And maybe a 

14 recommendation as to how we go about it, a 

15 little bit. You know, something like that.

16 CHAIRMAN RICHARDSON: Okay.

17 DR. NETON: I'm not trying to make 

18 more work for myself, I think that's important 

19 to be done in the context of this whole 

20 review. It doesn't make much difference and 

21 we could spend a lot of time discussing the 
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1 subtleties of adjustments and not much really 

2 return on our investment.

3 MR. KATZ: This is Ted. And just 

4 to add on to what Jim's saying, I mean SC&A's 

5 not on the line for this, but doesn't, I mean 

6 they have resources too so if this is 

7 something that, it makes a lot of sense to me 

8 too since it impacts how important the repeat 

9 work is, in a proximal sense.

10 But, so if this is something that 

11 you recommend and DCAS doesn't have resources 

12 to get to in a timely fashion and you want to 

13 plunge forward on that then you can consider 

14 using SC&A to do that kind of technical work.

15 CHAIRMAN RICHARDSON: Okay. 

16 Because I agree that as we report back to the 

17 Board it would useful to kind of contextualize 

18 the relative importance of some of the 

19 different issues that are out there in terms 

20 of scientific uncertainty.

21 And specifically within the 
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1 context of this program. Again it's going to 

2 be different that ICRP would bring to it.

3 So we might want to, that's where 

4 this Work Group might be able to add some 

5 value to this discussion, for this context. 

6 Well, that's what I had for the agenda. I 

7 think we, at least we have a way forward.

8 MEMBER ZIEMER: Sounds good.

9 CHAIRMAN RICHARDSON: So if 

10 there's no other questions. Bill, you'll get 

11 to your 3:15 meeting.

12 MEMBER FIELD: Sounds good.

13 CHAIRMAN RICHARDSON: Great. 

14 Would you like me to write up minutes of this 

15 conversation? Or how does that happen, Ted?

16 MR. KATZ: Well there'll be a 

17 transcript. That ordinarily takes 30 days or 

18 so to come out. So I think the only, I mean, 

19 we have a Board meeting on October 20th, I 

20 believe, the teleconference.

21 But I think reporting out there is 
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1 pretty simple right. So you don't need to 

2 produce any minutes of this meeting, we'll 

3 have that. But you probably should give a few 

4 minutes to tell the rest of the Board where 

5 we're headed.

6 CHAIRMAN RICHARDSON: Okay. Well 

7 great. Thanks.

8 DR. NETON: Okay. And I'll work 

9 to get that DDREF document out to the Board. 

10 Probably not until later in the week though.

11 CHAIRMAN RICHARDSON: Okay.

12 MEMBER ZIEMER: To the Board or 

13 just the Work Group?

14 DR. NETON: I'm sorry. The 

15 Working Group.

16 MEMBER ZIEMER: The Work Group.

17 MR. KATZ: Sounds good, so are we 

18 adjourned?

19 CHAIRMAN RICHARDSON: I think we 

20 are.

21 MR. KATZ: Thank you everybody.
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1 CHAIRMAN RICHARDSON: Bye.

2 (Whereupon, the above-entitled 

3 matter went off the record at 2:58 p.m.)

4 

5 

6 

7 

8 

9