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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 SCIENTIFIC ISSUES

+ + + + +

MONDAY

JUNE 20, 2011

+ + + + +

 The Work Group convened 

telephonically at 1:00 p.m., Eastern Daylight 

Time, Paul L. Ziemer, Acting Chair, presiding.

PRESENT:

PAUL L. ZIEMER, Acting Chair

R. WILLIAM FIELD, Member

JAMES E. LOCKEY, Member

WANDA I. MUNN, Member

JOHN W. POSTON,SR., Member

GENEVIEVE S. ROESSLER, Member
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ALSO PRESENT:

TED KATZ, Designated Federal Official

ISAF AL-NABULSI, DOE

IULIAN APOSTOAEI, ORAU Team

JENNY LIN, HHS 

JOHN MAURO, SC&A

JOHN TRABALKA, ORAU Team

JIM NETON, DCAS

JOHN STIVER, SC&A
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C-O-N-T-E-N-T-S 

 

 PAGE

Roll Call 4

Call to Order 6

Discussion on proposed revision

of the guidelines of non-radiogenic

cancers 7 
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1 P-R-O-C-E-E-D-I-N-G-S 

2 (1:01 p.m.)

3 MR. KATZ: So great. So Paul, 

4 you're on. It is now 1:00 p.m. by all my 

5 clocks, so why don't we see about, let's start 

6 with roll call beginning with the Board 

7 Members.

8 ACTING CHAIR ZIEMER: You can 

9 proceed with the roll call, Ted, if you want 

10 to and then we'll see if we have our group 

11 here.

12 MR. KATZ: Right. So beginning 

13 with the Board Members, and Paul has agreed to 

14 chair this session for this Work Group even 

15 though Dr. Richardson ordinarily chairs this 

16 Work Group.

17 ACTING CHAIR ZIEMER: And Wanda is 

18 here I heard.

19 MEMBER MUNN: Yes.

20 MEMBER POSTON: John Poston's 

21 here.

22 MEMBER ROESSLER: Gen Roessler's 
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1 here.

2 MEMBER LOCKEY: Jim Lockey's here.

3 ACTING CHAIR ZIEMER: And that's 

4 all the Board Members I believe that were on 

5 the Group, right, except for Dr. Richardson 

6 who's --

7 MEMBER ROESSLER: Dr. Lemen - 

8 ACTING CHAIR ZIEMER: Dr. Lemen 

9 will not be here today.

10 MR. KATZ: He cannot make it, 

11 right. So that's the full roster of Board 

12 Members we expect. So let's move on to NIOSH13 ORAU staff.

14 DR. NETON: Yes, this is Jim Neton 

15 in Cincinnati. 

16 DR. APOSTOAEI: Hello, we have 

17 here Iulian Apostoaei and John Trabalka from 

18 SENES Oak Ridge.

19 ACTING CHAIR ZIEMER: Okay.

20 MR. KATZ: Very good. SC&A staff?

21 DR. MAURO: John Mauro here from 

22 SC&A. Hi, everyone.
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1 ACTING CHAIR ZIEMER: Hi John.

2 MR. STIVER: John Stiver from 

3 SC&A.

4 MR. KATZ: Welcome to both of you. 

5 Agency officials or contractors to the Feds, 

6 HHS or other agencies?

7 MS. LIN: Jenny Lin, HHS.

8 DR. AL-NABULSI: Isaf Al-Nabulsi, 

9 DOE.

10 MR. KATZ: Welcome. And this is 

11 Ted Katz on the, Designated Federal Official 

12 for the Advisory Board. 

13 And last but not least, any 

14 members of the public on the line who wish to 

15 identify themselves?

16 Okay, then. We can carry on.

17 ACTING CHAIR ZIEMER: Okay, I'll 

18 officially call the meeting to order. I 

19 assume we have the official recorder in place.

20 MR. KATZ: We do.

21 ACTING CHAIR ZIEMER: Yes, we're

22 ready to proceed then and remind everyone when 
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1 you speak since the recorder may not know 

2 everyone's voice, to identify yourself as you 

3 make comments.

4 Our job today is to suggest some 

5 comments and perhaps some position paper to 

6 respond to the 42 CFR Part 81 docket on the 

7 proposed revision of the guidelines on non8 radiogenic cancers. 

9 Dr. Neton made a presentation on 

10 the NIOSH proposed revisions at our last full 

11 Board meeting. 

12 And I want to make sure everyone 

13 has before them a copy of the docket itself, 

14 which is Federal Register Volume 76, Number 

15 54, dated Monday, March 21. It is referenced 

16 as, the docket reference is RIN0920-AA39. 

17 Are there any of the Work Group 

18 Members that do not have a copy of that? It 

19 was part of our packet at the last meeting so 

20 I assume you all have that.

21 What I thought we would do, and 

22 let me outline my thoughts on how to proceed 
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1 on this and then we can get some comments 

2 back. 

3 The docket itself asks two main 

4 questions of commenters, although it doesn't 

5 limit comments to those questions. 

6 But it seems to me that it would 

7 be of value for the Board as proposed through 

8 this Work Group, would respond to the two main 

9 questions which are enumerated on Page 15268 

10 of the Federal Register of that particular 

11 reference. It's in the middle top among your 

12 public participation. 

13 The first question is, "Does 

14 epidemiological and other scientific research 

15 support finding that CLL is caused by 

16 radiation, and what are the major limitations 

17 of the determination (whether affirmative or 

18 negative)?” 

19 And the second question, which is 

20 a bit longer but let me go ahead and identify 

21 it. "If CLL were to be covered under EEOICPA, 

22 does the risk model proposed by the National 
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1 Institute for Occupational Safety and Health 

2 use the best available science and 

3 methodological approaches to express the dose4 response relationship between radiation 

5 exposure and CLL?" 

6 And I'm going to end the question 

7 at that point although there's some additional 

8 wording beyond that, but those are the two 

9 main questions. 

10 And it seemed to me that it would 

11 be at least appropriate for the Board to 

12 address those either in terms of saying we 

13 agree with NIOSH's position, or if we have 

14 concerns about it to identify what those might 

15 be. 

16 And then beyond those two if there 

17 are additional issues that we wish to address 

18 those could be enumerated. 

19 And this would be directed as per 

20 the docket instructions to the NIOSH docket 

21 office so that they would go into the public 

22 record. 
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1 So let me ask first if there's 

2 sort of general agreement that that's how we 

3 should proceed.

4 MEMBER LOCKEY: That sounds good 

5 to me, Paul.

6 ACTING CHAIR ZIEMER: Yes, and who 

7 else has --

8 MEMBER LOCKEY: It's Jim Lockey.

9 MEMBER MUNN: And this is Wanda. 

10 That seems reasonable if you choose not to 

11 address the other lesser questions.

12 ACTING CHAIR ZIEMER: Well, I'm 

13 not saying not to address them. I'm just 

14 saying those are the two main ones that are 

15 identified in the docket. It would seem to me 

16 it would be useful.

17 MEMBER MUNN: Well, certainly 

18 there are two scientific issues here.

19 ACTING CHAIR ZIEMER: Yes.

20 MEMBER ROESSLER: And this is Gen. 

21 I agree that that's an appropriate procedure 

22 here.
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1 MR. KATZ: Paul?

2 ACTING CHAIR ZIEMER: Yes.

3 MR. KATZ: This is Ted. And this 

4 is sort of a friendly amendment to your 

5 suggestion about providing your comments to 

6 the docket. 

7 You are actually, this is part of 

8 the Board's charter, to advise the Secretary 

9 on these guidelines. So in fact, I believe 

10 and I think this is how we've done it in the 

11 past, the Board would send a letter to the 

12 Secretary, I mean that will be put in the 

13 docket by NIOSH as well, but --

14 ACTING CHAIR ZIEMER: Okay, I 

15 wasn't quite certain of the route, but either 

16 way the intent is to put it in the public 

17 record. So what you're saying is it would go 

18 to the Secretary and then by that route would 

19 feed back to NIOSH. 

20 MR. KATZ: Right.

21 ACTING CHAIR ZIEMER: Yes, and it 

22 certainly wasn't my intent that we bypass the 
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1 Secretary. I was just looking at the 

2 instructions in the docket itself and that's 

3 where it said to submit them. But I 

4 understand that the point is we actually 

5 advise the Secretary, so that would be 

6 appropriate. 

7 Let me also add an additional 

8 comment or a thought here. And the first 

9 thing is, the question is, "Does 

10 epidemiological and other research support the 

11 finding that CLL is caused by radiation?" 

12 One of the concerns that I had was 

13 that for the most part, and although not 

14 completely, but most of our Board Members are 

15 not in a position technically to evaluate that 

16 research. 

17 I certainly don't consider myself 

18 in a position to evaluate that epi research 

19 that's basis for this, and in fact have to 

20 rely on those who are experts. 

21 Now we do have on the Board some 

22 epidemiological people. In fact, one of the 
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1 persons who's not able to participate with us 

2 was one of their NIOSH evaluators whose 

3 comments are in the docket. 

4 So we already know that we have a 

5 high level of expertise amongst our Board and 

6 that person's expertise is reflected in some 

7 of the comments here. 

8 And we have a couple of others on 

9 the Board who have epidemiological background. 

10 But it seemed to me from my own 

11 personal point of view and I think a lot of, 

12 and I would sort of assume that the other 

13 nontechnical people might feel this way, that 

14 we very much have to rely on the evaluations 

15 made by those international experts that NIOSH 

16 has itself relied upon to evaluate the 

17 scientific literature. 

18 So one of the things that I would 

19 expect perhaps to include in the comments 

20 would be the fact that we are not specifically 

21 as a Board evaluating the actual scientific 

22 literature on this, but we are evaluating the 
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1 process that NIOSH used to reach their 

2 conclusion. 

3 That is I, for example, would be 

4 willing to accept the fact that the top 

5 experts in this field have reached a somewhat 

6 inconclusive but not, it's sort of a negative 

7 way of going about it in saying, we can't show 

8 that CLL is not radiogenic. 

9 And therefore in keeping with the 

10 policy that says that we will, for claimant 

11 favorability, will make certain policy 

12 decisions that we would accept CLL on that 

13 basis. That it's appropriate in that NIOSH's 

14 approach for erring on the side of the 

15 claimant when the scientific knowledge is 

16 lacking. 

17 And at least it's soon clear to me 

18 that there's no consensus that would rule out 

19 CLL as being radiogenic. There's not a full 

20 consensus that it is, but not a consensus that 

21 you can rule it out either.

22 MEMBER ROESSLER: Paul, I have a 
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1 comment.

2 ACTING CHAIR ZIEMER: I was 

3 thinking of it in those terms, so let's get 

4 some feedback on that. 

5 Yes, Gen Roessler?

6 MEMBER ROESSLER: Yes, this is 

7 Gen. Before I make my comment on what you 

8 just said, I noticed I'm on the website, the 

9 NIOSH website, and it looks like Dr. Field is 

10 also on this committee. Now he is an 

11 epidemiologist. 

12 I'm wondering if that listing is 

13 wrong or is he not on this group?

14 MEMBER FIELD: Gen. Gen, I'm on 

15 the phone. This is Bill Field.

16 MEMBER ROESSLER: Oh, okay. I 

17 didn't hear your name. Okay, so we can --

18 MEMBER FIELD: Yes, I was here at 

19 the very beginning.

20 MEMBER ROESSLER: Yes, okay. Then 

21 I guess then Paul --

22 ACTING CHAIR ZIEMER: Yes, I said 
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1 we have some Board Members who are in that 

2 position, but if we want to speak for the full 

3 Board we may --

4 MEMBER ROESSLER: Yes, I just 

5 wondered if Bill was on and he is. Then I 

6 guess I'll continue. 

7 Before we started the phone call, 

8 I wrote down some thoughts which I think agree 

9 pretty well with what you just said. 

10 My conclusion after reading 

11 through this very complicated material is that 

12 personally I don't disagree with the approach 

13 to add CLL, even though I'm not convinced that 

14 CLL is radiogenic. I think it's as you say, 

15 inconclusive. 

16 But again as you said, making a 

17 change like this is consistent with NIOSH's 

18 procedure to err on the side of the claimant 

19 when the state of scientific knowledge is 

20 lacking. 

21 So I think I'm just sort of saying 

22 yes, Paul, I agree with what you just said.
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1 ACTING CHAIR ZIEMER: Right. It 

2 seemed to me, and again I'm relying on the 

3 experts, and most of those I recognize the 

4 names and they're the individuals, if somebody 

5 raised the question I would have said, ask 

6 that person, ask that person. 

7 There's obviously sort of a split 

8 amongst the experts, but it's not conclusive 

9 but we approach it in a sense from a policy 

10 point of view. 

11 So at least as I would personally 

12 approach it would be to say, for example, if 

13 we agreed with the fact that it appears from 

14 the experts that we cannot rule out CLL as 

15 being radiogenic that we therefore under the 

16 stated policy, that we proceed with the 

17 concept that we include it as a claimant18 favorable approach where the science is 

19 lacking. 

20 MEMBER MUNN: Paul, this is Wanda. 

21 I would not disagree with anything that 

22 you've said so far. It's very clear I think 
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1 from the outset this is another one of those 

2 cases that we've been faced with for the last 

3 decade of attempting to prove a negative, 

4 which of course is not going to happen. 

5 I also agree with your comment 

6 with respect to our ability to analyze the 

7 original material and the literature that's 

8 out there. 

9 However, the people on this 

10 particular Work Group in my humble opinion are 

11 certainly categorically capable of analyzing 

12 the comments that were made by the experts 

13 with respect to those reviews. 

14 And that being the case, we 

15 understand, for example, what the reviewer 

16 means when he says that "the CLL induction 

17 weighs heavily towards the conclusion that CLL 

18 is similar to other hematological malignancies 

19 whose etiology involves structural changes at 

20 the chromosomal level".

21 We understand that and are able to 

22 evaluate that in a fairly objective way I 
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1 think. 

2 I think what I heard you say, 

3 which is my personal view after absorbing as 

4 much as I could of this, that there still is 

5 no clear cut answer to, is CLL radiogenic? 

6 I personally suspect that it 

7 probably is not, but there is no way to prove 

8 that and there is some evidence that it might 

9 be. 

10 Therefore, as you've already 

11 stated, NIOSH in my view has no option other 

12 than to follow the course that they have laid 

13 out in this ruling.

14 ACTING CHAIR ZIEMER: Okay, other 

15 comments? 

16 I'm trying to get a feel for 

17 whether there's a consensus towards the first 

18 question, and that's the question of including 

19 CLL on the list of radiogenic cancers within 

20 the framework of the manner in which it's 

21 outlined by NIOSH in terms of both the 

22 uncertainty of the conclusion as well as the 
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1 policy part of it that says that in the 

2 absence of sufficient scientific information 

3 that would conclude that it was not that we 

4 take the position that it is. 

5 And then if the answer to that is 

6 yes then we can proceed to the model issue. 

7 MEMBER MUNN: Yes, that it is 

8 under certain circumstances.

9 ACTING CHAIR ZIEMER: Bill Field, 

10 do you have any sort of comment on this in 

11 terms of the epidemiology at this point?

12 MEMBER FIELD: Yes, and I guess my 

13 view of this starts, what was the evidence to 

14 I guess initially determine that it was not? 

15 And I think the primary basis for 

16 that conclusion was based on the atomic bomb 

17 survivors, and we know that CLL is a very rare 

18 cancer for the Japanese population. 

19 So I guess part of it goes back to 

20 the generalizability of those in that 

21 population and very intense but short-term 

22 exposures producing CLL that could be 
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1 identified epidemiologically was the initial I 

2 guess premise that it's not radiogenic. 

3 But I think there's been some 

4 studies, and from my perspective, I'm the 

5 author of one of the studies that had to do 

6 with radon and CLL and I took part in a 

7 conference that was organized by NIOSH where 

8 experts came from all over the country to 

9 review just the subjects. 

10 Yes, I must say I don't think 

11 there's anything that clearly points to CLL 

12 until it clearly demonstrates that it is 

13 radiogenic. But I think there is subjective 

14 evidence to suggest that it may be. 

15 I guess I have that view of it, 

16 but I think at this point the evidence from my 

17 perspective is stronger that it is radiogenic 

18 than the evidence that it's not. That's sort 

19 of my basis for belief. 

20 But I think what the Agency says 

21 is that the Agency finds the evidence of 

22 radiogenicity offered by epidemiology to be 
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1 non-determinative, but no longer believes it's 

2 possible to state that the Probability of 

3 Causation equals zero. I guess I agree 

4 completely with that statement.

5 ACTING CHAIR ZIEMER: And if it's 

6 not zero that means there's a slight, there's 

7 some risk, and then you go from there to what 

8 is the risk model. 

9 Let me get other comments on this 

10 first question then. Others reflect or agree 

11 with what Ted and Gen have stated? Because if 

12 we have agreement I'm going to shoot you all 

13 an email in about a couple minutes which has 

14 some suggested wording. 

15 But I don't a wordsmith right here 

16 right now, I want to get sort of a general 

17 consensus.

18 MEMBER FIELD: Paul, this is Bill 

19 again. I haven't seen the review from the one 

20 reviewer that did not think there was 

21 evidence. Is that available somewhere?

22 ACTING CHAIR ZIEMER: Let's see, 
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1 I can catch Jim Neton on the line here. I 

2 think the reference is given. I'm looking in 

3 the footnotes right now.

4 DR. NETON: Paul, I can give you 

5 that reference. It's John Boice's review and 

6 it's, if you look on the regulatory docket 209 

7 it's the fifth one down from the subject 

8 matter expert reviews, labeled "Boice, 

9 Reconsideration of Chronic Lymphocytic 

10 Leukemia."

11 MEMBER FIELD: And Jim, where 

12 would you find that, the actual review?

13 DR. NETON: It's actually his 

14 report and it's on the regulatory docket 

15 associated with this NPRM. And the regulatory 

16 docket can either be gotten directly off of a 

17 NIOSH website or our DCAS website.

18 MEMBER FIELD: Okay, because I 

19 think if we're going to change policy it'd be 

20 I think worthwhile to at least, or at least 

21 suggest a change, at least be worthwhile to 

22 consider what his thinking is not to believe 
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1 it's not zero.

2 DR. NETON: Sure. It's available.

3 MEMBER MUNN: Jim, didn't one of 

4 our either Work Groups or Subcommittees have 

5 all of those reports available at one time? 

6 I've read them.

7 DR. NETON: Well, they're all 

8 listed like I say in the regulatory docket 

9 online. I made sure we got them all there. 

10 I don't think we actually reviewed 

11 these reports separately in a Work Group 

12 though because this was undergoing rule making 

13 and we were pretty circumspect about what we 

14 talked about.

15 MEMBER MUNN: Well, I found them 

16 somewhere. I remember reading.

17 DR. NETON: Yes, it was a John 

18 Boice review that the only one of all of them 

19 out of the five, that one review John Boice 

20 said definitely not. 

21 There was another review that said 

22 it's difficult to tell, and the other three 
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1 basically agreed that it should not continue 

2 to be excluded.

3 MEMBER LOCKEY: Bill Field? 

4 MEMBER FIELD: Yes.

5 MEMBER LOCKEY: Hi, Jim Lockey. 

6 Wasn't there a meta-analysis done, I'd have to 

7 go back and look what I read, but that said 

8 that there was an elevated rate, like for 38 

9 studies or something and that included in the 

10 meta-analysis and there was like six percent 

11 increased risk? 

12 MEMBER FIELD: That doesn't ring a 

13 bell. Does that ring a bell to you, Jim?

14 DR. NETON: No, I don't recall a 

15 meta-analysis showing an increase risk for 

16 CLL. The only real positive association I 

17 think I've seen is the one with the Czech 

18 uranium miner study that came out a few years 

19 back that identified a significant excess 

20 relative risk. 

21 There's been a number of studies 

22 that have since the rule was published early 
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1 on, identified excess relative risk but they 

2 were not statistically significant. 

3 But I agree with Bill Field that 

4 the weight of the evidence seems to be 

5 shifting a little bit. You start compiling 

6 enough studies that show us excess relative 

7 risk even though it's not significant, you 

8 start to question the assignment of zero 

9 probability. 

10 MEMBER FIELD: Right, Jim. And 

11 the paper you're talking about that's Rericha 

12 and Dale Sandler I think was on that paper and 

13 some others. And I think NCI was very 

14 critical?

15 DR. NETON: Yes.

16 MEMBER FIELD: I talked to Dale 

17 about that. NCI was very critical in 

18 identification of CLL in their registry, was 

19 it clearly CLL they were seeing. 

20 One of the problems with doing 

21 these mortality, where these studies that most 

22 of these that are done look at mortality as an 
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1 end point and a lot of these don't show up on 

2 death certificates. 

3 So what was different about that 

4 study that was performed that Jim just 

5 discussed, that was a paper that didn't look 

6 at mortality as an outcome. It looked at 

7 incidence through an incidence registry.

8 MEMBER LOCKEY: Yes, this is Jim 

9 Lockey. The study I was thinking about was 

10 non-ionizing radiation. I'm sorry, I got it 

11 confused. Okay.

12 ACTING CHAIR ZIEMER: Well, yes, 

13 any further -- so Dr. Boice's arguments also I 

14 guess went to mechanism as well the causation. 

15 I think he talked about chemical studies as 

16 well. Isn't that correct?

17 DR. NETON: That's correct.

18 MEMBER FIELD: This is Bill Field. 

19 And I think for mechanistic arguments it's 

20 very difficult because we're not really sure 

21 what the target organ is. 

22 So I think it's very difficult to 
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1 really be able to predict what the mechanistic 

2 pathways are or what the causal pathways are 

3 from a biological viewpoint.

4 ACTING CHAIR ZIEMER: Okay, any 

5 further comments on the first question of 

6 inclusion of CLL in the list?

7 All right, if not let's talk for a 

8 moment about the second one which has to do 

9 with mechanism. There's several parts to 

10 this. 

11 One is as NIOSH pointed out, CLL 

12 is now classified as a form of non-Hodgkin's 

13 lymphoma and that seems to be important in 

14 terms of thinking how to model it. 

15 So NIOSH proposes a risk model 

16 that is in essence similar to the use of 

17 lymphoma and multiple myeloma risk models. 

18 They have a latency period which is based on 

19 some bit of scientific evidence, and it 

20 appeared to me at least from what I could read 

21 about this that they have selected a pretty 

22 conservative midpoint value for the latency 
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1 period, 10-year. Originally they had selected 

2 15 and it's now 10. They have a fairly large 

3 uncertainty spread in the midpoint of five 

4 years. 

5 And then they're using an approach 

6 where they determine the weighted dose to the 

7 B lymphocytes based on the dose to a given 

8 site and the probability that a B-cell 

9 precursor will occupy that particular site. 

10 So that's the way they have modeled it. 

11 It seemed to me that one could 

12 argue that that is a model that in a sense

13 uses the best available science from what we 

14 know about both this particular type of cancer 

15 as well as what the way you might go about 

16 doing the dose reconstruction. 

17 And Jim outlined this pretty well 

18 of using the weighted doses, in his 

19 presentation at our meeting. So let me get 

20 comments on that. 

21 Is the model appropriate and 

22 scientifically defensible? 
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1 MEMBER MUNN: This is Wanda.

2 ACTING CHAIR ZIEMER: Any 

3 comments?

4 MEMBER MUNN: Yes. I believe so, 

5 and one could always argue the level of 

6 uncertainty and I think you could bring 

7 arguments there either way on it. 

8 But the choice of five years 

9 certainly seems reasonable and should be 

10 claimant friendly.

11 ACTING CHAIR ZIEMER: Other 

12 comments?

13 MEMBER FIELD: Jim, this is Bill. 

14 I agree. I think it's very rational and 

15 certainly and sort of an outline given what we 

16 know.

17 MEMBER LOCKEY: Yes Paul, Jim 

18 Lockey. I agree with that. I mean there's 

19 uncertainties, but by the nature of what we're 

20 doing the benefit goes to the claimant so I 

21 would agree with the model.

22 MEMBER ROESSLER: This is Gen. I 
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1 do too. I'm going mostly on what I remember 

2 from Jim Neton's presentation to us not only 

3 this past time but before. 

4 I think when you read this Federal 

5 Register material it's a little bit hard to 

6 wade through it and really figure out what the 

7 risk model is. But I base mine on what Jim 

8 had discussed with us at several meetings.

9 ACTING CHAIR ZIEMER: Well, it 

10 was a weighted dose. It's done similar to how 

11 you calculate the risk from organ doses when 

12 you're doing the weighted ICRP models. 

13 Jim, you talked about that.

14 DR. NETON: Yes, and it's exactly 

15 that. It's analogous. It's a weighted dose 

16 because for internal exposures it's a non17 uniform exposure, and then you have to 

18 calculate the weighted dose to which B 

19 lymphocytes are exposed over time. 

20 If it was an external parallel 

21 beam exposure there would be no weighting 

22 involved of course, but our biggest challenge 
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1 in this business is the internal dose.

2 DR. MAURO: This is John Mauro. 

3 If I could just come in with a thought. As I 

4 was listening it seems that there's a line 

5 that's being blurred in my mind that the first 

6 part of your conversation went toward whether 

7 or not it's a go, no go, yes, we need to 

8 assume that CLL can be caused by radiation 

9 exposure. 

10 Next question I thought I would 

11 hear more about is okay, given that we'll go 

12 down that road it becomes like a risk per rem 

13 and what's the risk coefficient? And that 

14 sort of blends in a funny sort of way with 

15 well, what tissue are we talking about? 

16 So there's a blending of the risk 

17 per rem and the modeling of the rem. In other 

18 words, you have two, it's almost like three 

19 steps. 

20 Yes, there's effect, we think 

21 there might be a bad effect. Two, what is the 

22 risk coefficient, the lifetime risk of a 
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1 cancer program, of that particular cancer 

2 program. And what are the rem, what are the 

3 dose and to what tissue? 

4 I'm having a little trouble in the 

5 last two, they seem to be overlapping in my 

6 mind. 

7 DR. NETON: John, this is Jim. 

8 The risk per rem is independent of the dose.

9 DR. MAURO: Yes.

10 DR. NETON: It's the standard risk 

11 model that we would use for multiple myeloma 

12 and lymphoma. 

13 So that's a stand-alone risk model 

14 by itself, excess relative risk per sievert 

15 with the various adjustments applied.

16 DR. MAURO: Oh, so your risk 

17 coefficient is presuming that the 

18 radiosensitivity so to speak is the same as it 

19 would be for multiple myeloma?

20 DR. NETON: With some adjustments.

21 DR. MAURO: Okay, I didn't follow 

22 that. 
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1 DR. NETON: Right. And that's the 

2 risk model itself. 

3 Now you do bring up another point 

4 though which is the dose reconstruction which 

5 is particularly unique to this chronic 

6 lymphocytic leukemia and frankly other 

7 lymphomas, which is what's the target organ? 

8 And those are very hard to separate. 

9 The risk model is there but we 

10 included in the risk model discussion how 

11 we're going to do the dosimetry because it was 

12 frankly a fairly difficult issue to deal with 

13 and we wanted to make sure that people 

14 understood how we were approaching it. But it 

15 is a separate issue. 

16 There's three issues here really. 

17 There's the, is it radiogenic? If it is, or 

18 should be considered radiogenic, if it is what 

19 is the risk coefficient or risk model that 

20 will be applied? And if you do have a risk 

21 model how are you going to calculate the dose 

22 of the target organ?
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1 DR. MAURO: Right.

2 DR. NETON: Unfortunately, the way 

3 that the Federal Register notice came out, it 

4 really only appears to question, ask questions 

5 regarding the first two of those. But 

6 embedded in that is this dosimetry calculation 

7 as well. I hope that clarifies it.

8 ACTING CHAIR ZIEMER: And if it's 

9 a whole body external dose that's one thing. 

10 If it's an internal with specific organs are 

11 radiated that's a separate different thing in 

12 the calculation. But either way you're doing 

13 the weighted organ situation depending on 

14 whether it's a uniform to everything or a 

15 specific organ or several organs.

16 DR. NETON: Well, we wouldn't 

17 necessarily weight on a uniform whole body 

18 exposure. 

19 ACTING CHAIR ZIEMER: No.

20 DR. NETON: There are some 

21 adjustments that can be made. They're trivial 

22 compared to the what we do for internal 
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1 though, you're right.

2 ACTING CHAIR ZIEMER: I have a 

3 draft of some proposed comments and they would 

4 follow from what we have talked about here. I 

5 didn't want to send them out in advance 

6 because I didn't want to necessarily bias 

7 thoughts that you might have had. 

8 But they now have gone into 

9 cyberspace and depending on --

10 MEMBER ROESSLER: They have come 

11 through.

12 ACTING CHAIR ZIEMER: They are 

13 through? Boy, they came through faster than I 

14 can walk from my computer back to the table 

15 here.

16 MEMBER ROESSLER: Yes, well, I 

17 just got them.

18 ACTING CHAIR ZIEMER: Faster than 

19 a speeding bullet.

20 MEMBER ROESSLER: Yes.

21 MEMBER MUNN: They've even 

22 traveled all the way to Washington State.
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1 ACTING CHAIR ZIEMER: Really? 

2 Isn't that astounding?

3 MEMBER MUNN: Yes.

4 MEMBER POSTON: It's too hot in 

5 Texas for them, they're not here yet.

6 MEMBER MUNN: Things have always 

7 been a little slower there, John.

8 ACTING CHAIR ZIEMER: Yes, well, 

9 the Pony Express isn't quite as fast I guess.

10 Anyway, has that reached 

11 everybody? Or do you have your emails open?

12 MEMBER LOCKEY: Yes, I have mine.

13 MEMBER POSTON: Still lagging 

14 behind.

15 ACTING CHAIR ZIEMER: Now this 

16 was sent to everyone who was on the Ted Katz 

17 mail-out of the meeting announcement. So I 

18 think, Jim, did it -- I'm not sure. John 

19 Mauro and Jim, were you on that list?

20 DR. NETON: I got a copy, Paul.

21 ACTING CHAIR ZIEMER: Okay.

22 DR. MAURO: I'm not sitting at my 
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1 computer right now so I --

2 ACTING CHAIR ZIEMER: Oh, okay. 

3 DR. MAURO: Please go ahead.

4 ACTING CHAIR ZIEMER: Okay.

5 MEMBER POSTON: Paul, this is 

6 Poston and I still don't have it.

7 MEMBER ROESSLER: Thank you, Paul, 

8 for sending it to the email addresses that are 

9 not CDC. I didn't warm up my CDC computer 

10 this morning. 

11 ACTING CHAIR ZIEMER: Well, I 

12 sent it to where Ted does and he usually sends 

13 them to multiple addresses. 

14 John Poston's on that list, right? 

15 Ted, are you there?

16 MR. KATZ: Yes, I'm here. And 

17 John's on that list.

18 MEMBER ROESSLER: He's on the list 

19 but it's using his CDC address.

20 MEMBER POSTON: Yes, so send it to 

21 j-poston@tamu.edu. That's where I am.

22 ACTING CHAIR ZIEMER: Okay, I'm 
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1 going to resend here, John, to you. Just one 

2 second here. Let me pull this back up.

3 Okay, now when I drafted this you 

4 see I addressed it the Docket Office. That 

5 would all change, okay?

6 Okay, so there's three sort of 

7 parts to this and let's just take a look. And 

8 you can polish this further but I want to sort 

9 of see if this is the sense of what we want to 

10 say. 

11 Number one, Board offers, and of 

12 course this would go to the Board for 

13 approval. The Board offers the following 

14 comments on the question, "Does 

15 epidemiological and other scientific research 

16 support the finding that CLL is caused by 

17 radiation?" 

18 First bullet, although most 

19 Members of the Board do not have expertise in 

20 epidemiological research, we are able as a 

21 Group to assess the approach used by NIOSH to 

22 answer this specific question. That approach 
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1 has been detailed in docket number NIOSH 209. 

2 Through the use of recognized 

3 experts NIOSH has been able to demonstrate 

4 that the available epidemiological evidence is 

5 insufficient to rule out an association 

6 between ionizing radiation and CLL. 

7 Second bullet, including CLL as 

8 radiogenic is appropriate in that it follows 

9 NIOSH's approach of erring on the side of the 

10 claimant when scientific knowledge is lacking. 

11 So those are the comments on that 

12 first question. Are those appropriate and are 

13 there others that should be added?

14 MEMBER MUNN: This is Wanda. They 

15 appear appropriate to me. You need to spell 

16 out CLL the first time. 

17 ACTING CHAIR ZIEMER: Yes.

18 MEMBER ROESSLER: And this is Gen. 

19 I would on the second bullet perhaps put 

20 something like "therefore, if it's appropriate 

21 to include CLL" and so on. The second bullet 

22 really follows from the first one.
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1 ACTING CHAIR ZIEMER: Okay. Yes, 

2 we can do additional wordsmithing, but I want 

3 to make sure that the statements are 

4 conceptually correct and acceptable keeping in 

5 mind we need full Board approval. So I want 

6 to make sure that those who are not technical 

7 will feel comfortable. 

8 I think this does not say that we 

9 have reviewed all the underlying scientific 

10 evidence. It basically says we believe that 

11 NIOSH took the right approach.

12 MEMBER LOCKEY: Paul?

13 ACTING CHAIR ZIEMER: Yes.

14 MEMBER LOCKEY: When I was looking 

15 at the language, "epidemiology evidence is 

16 insufficient to rule out", it's insufficient, 

17 rule out back to back. 

18 I was just wondering if there's 

19 another way to reword that. 

20 ACTING CHAIR ZIEMER: Well, I 

21 think the double negative is almost needed. 

22 It's not sufficient to rule it in.
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1 MEMBER LOCKEY: I know that. I 

2 was just trying to, I can understand this 

3 double negative. I was just wondering what 

4 another way to say it that way and then I 

5 dropped it. 

6 Let me look at it. If I come up 

7 with something I'll --

8 ACTING CHAIR ZIEMER: All right. 

9 Okay, I thought in a certain sense you were 

10 trying to prove the negative and you can't 

11 prove it so it's insufficient to disprove it. 

12 Well, okay, shall I move on? Or 

13 are we sort of okay with this given that we'll 

14 allow between now and whenever, we'll allow 

15 additional time for people to, I know this is 

16 hitting you suddenly but it, sort of had a 

17 pre-discussion on it and I want to see if 

18 we've captured it correctly. 

19 Shall I move on?

20 MEMBER MUNN: Let's move on.

21 ACTING CHAIR ZIEMER: Second 

22 item, this is really a statement that we agree 
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1 with the reason for doing it this way. The 

2 Board agrees with the NIOSH position set forth 

3 in the docket, and then I quote that, "given 

4 that the law requires the use of the upper 99 

5 percent credibility level in making 

6 compensation decisions, the inclusion of CLL 

7 despite the limited evidence of radiogenicity 

8 it's considered appropriate by NIOSH." 

9 Now that's NIOSH's own statement. 

10 And I'm proposing that we endorse that. Any 

11 concerns? I guess not. 

12 Okay, third item. The Board 

13 offers the following comments on the question, 

14 "If CLL were to be covered by EEOICPA, does 

15 the risk model proposed by the National 

16 Institute of Occupational Safety and Health 

17 use the best available science and 

18 methodological approaches to express the dose19 response relationship between radiation 

20 exposure and CLL? 

21 First bullet, we agree that the 

22 use of the lymphoma and multiple myeloma risk 
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1 model as a starting point is appropriate given 

2 the fact that CLL is now classified as a form 

3 of non-Hodgkin's lymphoma. 

4 Second point, the proposed risk 

5 model makes use of the available scientific 

6 literature concerning the latency period for 

7 CLL and selects a conservative, claimant8 favorable value for the midpoint of the 

9 latency period. 

10 Third, the proposed uncertainty 

11 band for the midpoint of the latency period is 

12 sufficiently large so as to fairly reflect the 

13 spread seen in available studies. 

14 And finally, we concur with the 

15 approach of using the weighted radiation dose 

16 to the B lymphocytes based on the dose to a 

17 given site and the probability that a B-cell 

18 precursor for CLL will occupy that site.

19 MEMBER ROESSLER: This is Gen. I 

20 have a comment on the first bullet. Okay, the 

21 end part, "given the fact that CLL is now 

22 classified as a form of non-Hodgkin's 
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1 lymphoma", should we say who has now 

2 classified it?

3 ACTING CHAIR ZIEMER: It'd 

4 probably be good to do that. 

5 MEMBER ROESSLER: I don't 

6 remember.

7 ACTING CHAIR ZIEMER: I'm 

8 thinking it was an international group. Jim, 

9 can you help us?

10 DR. NETON: Yes, I'm wondering if 

11 the World Health Organization?

12 MEMBER ROESSLER: Yes, WHO I 

13 think.

14 ACTING CHAIR ZIEMER: Classified 

15 by the World Health Organization.

16 MEMBER ROESSLER: I think that 

17 would add weight to that.

18 ACTING CHAIR ZIEMER: Good.

19 MEMBER MUNN: Was NCI in there? 

20 DR. NETON: Yes, NCI also.

21 ACTING CHAIR ZIEMER: Then 

22 National Institute itself, or National Cancer 
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1 Institute, yes.

2 DR. NETON: I have to go back to 

3 the original document to get this 

4 specifically.

5 MS. LIN: Yes, you're correct. 

6 It's NCI and WHO. It's on Page 15271.

7 DR. NETON: Okay, thanks.

8 ACTING CHAIR ZIEMER: Okay, I'll 

9 add both of those to this. Good, thank you. 

10 Other comments? 

11 MEMBER LOCKEY: Paul, Jim Lockey. 

12 Let me see what you think about this language 

13 in that "insufficient to rule out." 

14 Available epidemiology evidence 

15 supports a possible and biologically plausible 

16 association, is that too strong? Epidemiology 

17 evidence supports a possible and biologically 

18 plausible association between ionizing 

19 radiation and CLL.

20 MEMBER ROESSLER: I don't think 

21 that's really what we're saying here. That's 

22 pretty strong.
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1 MEMBER LOCKEY: How about this, 

2 "possible association" and take out the 

3 biological plausibility?

4 MEMBER ROESSLER: I think that's 

5 still too strong. I think the "insufficient 

6 to rule out" is really what we're going on.

7 MEMBER MUNN: And the 

8 classification by non-Hodgkin's lymphoma by 

9 WHO and NCI.

10 MEMBER LOCKEY: Okay.

11 ACTING CHAIR ZIEMER: We might be 

12 able to do both by saying there may be a 

13 possible, well let's see.

14 MEMBER LOCKEY: Well, there is 

15 some studies that says a possible association, 

16 elevated risk, right?

17 MEMBER ROESSLER: But then there 

18 are some that say there isn't.

19 MEMBER LOCKEY: And there's some 

20 that say there isn't, right.

21 DR. NETON: This is Jim. There 

22 are none that have a statistically significant 
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1 result except for --

2 (Simultaneous speaking.)

3 MEMBER LOCKEY: So you would say 

4 that was possible, right, Jim?

5 DR. NETON: Yes, I would say. 

6 Yes.

7 MEMBER FIELD: Yes, I think I'd 

8 pick the word "epidemiology" is used as 

9 suggested, suggestive association.

10 MEMBER LOCKEY: Suggested to me is 

11 stronger than possible.

12 MEMBER FIELD: Yes.

13 MEMBER MUNN: And it's still truly 

14 uncertain.

15 MEMBER LOCKEY: Or you could say 

16 "a possible but uncertain", how about that? 

17 "A possible but uncertain association", 

18 supports a possible but uncertain association?

19 MEMBER ROESSLER: Sounds better.

20 ACTING CHAIR ZIEMER: Possible 

21 but uncertain association.

22 MEMBER FIELD: I guess when I hear 
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1 that I think what's the uncertain part? Is it 

2 the confidence interval?

3 ACTING CHAIR ZIEMER: You mean 

4 just, how about just the possible? What if we 

5 said, "because some studies suggest the

6 possible association, NIOSH has demonstrated 

7 that the available evidence is insufficient to 

8 rule out?" No, let's see. That's a little 

9 too wordy.

10 MEMBER ROESSLER: Perhaps we 

11 should just leave it and the Board Members 

12 might have other ideas. I think it says what 

13 we intend to it's just cumbersome.

14 MEMBER LOCKEY: It is cumbersome. 

15 And "insufficient to rule out," I'm not sure 

16 what that means. That's why I was, I know 

17 what possible means. That usually means 33 

18 percent, something like that. But I don't 

19 know what insufficient to rule out means.

20 MEMBER MUNN: Well, it means you 

21 don't have enough information to say 

22 absolutely it's, can you prove that negative?
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1 ACTING CHAIR ZIEMER: And that may 

2 have actually been one of NIOSH's own 

3 statements. I'm looking to see. 

4 Does that ring any bells, Jim?

5 MS. LIN: The statement that you 

6 have "insufficient to rule out" actually comes 

7 from one of the reviewer, and NIOSH quoted 

8 that. It doesn't necessarily mean that that's 

9 the language that NIOSH will use to describe 

10 CLL sufficient. 

11 Page 15270, the second paragraph 

12 is, one reviewer concluded that "the available 

13 evidence is insufficient to rule out an 

14 association between ionizing radiation and 

15 CLL," end of quote. 

16 ACTING CHAIR ZIEMER: All right, 

17 yes. See, it's right there in the docket.

18 MEMBER LOCKEY: That was one of 

19 the reviewers though. We could say "supports 

20 a possible but not firm association"?

21 MS. LIN: I think if I'm to take a 

22 sentence from this NPRM and say that that's 
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1 NIOSH's position I would say that it just 

2 doesn't, it can no longer say that the PoC is 

3 zero.

4 DR. MAURO: This is John Mauro. I 

5 have a thought on this. The term 

6 "insufficient to rule out" on the surface 

7 sounds fine. But then you realize that 

8 statement is true about an innumerable number 

9 of biological endpoints.

10 MEMBER LOCKEY: Absolutely, that's 

11 the problem. That's my problem with that 

12 statement. You could say that about anything.

13 Most anything, not everything but 

14 almost. I'm sorry, I shouldn't have been so 

15 dogmatic.

16 ACTING CHAIR ZIEMER: Okay, well, 

17 I'll tell you what. Let's work, we don't want 

18 to spend all our time wordsmithing this now. 

19 Let me work on it and if others of 

20 you have some wording just send it to me and 

21 I'll take what you get and prepare a final 

22 thing to supply to the Board for their meeting 
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1 and then we'll have another crack at it.

2 Would that be agreeable? 

3 In other words, we want to get rid 

4 of the "insufficient to rule out" and put in 

5 some terms that indicate that there could be 

6 an association.

7 That's the point, right?

8 MEMBER MUNN: Well, some of us are 

9 not so hot about completely abandoning the 

10 "insufficient to rule out." That means 

11 something in my mind and I think it would mean 

12 something in the mind of a nontechnical reader 

13 or a reviewer who was not completely steeped 

14 in the full depth of the literature. It 

15 simply means you don't have enough to say for 

16 sure that it's not true. 

17 ACTING CHAIR ZIEMER: Well, I 

18 think we're sort of all agreeing with the 

19 concept, and the question is do we have it 

20 worded in a way that we're all comfortable 

21 with. 

22 And let me just suggest that you 
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1 all give it some additional thought and send 

2 me suggested wording for that sentence. And 

3 then let me take a look at it so that we don't 

4 have to spend a half hour here today on a 

5 particular sentence. I think right now it's 

6 of agreeing conceptually.

7 MEMBER LOCKEY: Yes, I agree.

8 ACTING CHAIR ZIEMER: Okay. Now 

9 with that exception of that particular phrase, 

10 are there other points that need to be added 

11 to this document or any major heartaches with 

12 it?

13 MEMBER MUNN: No.

14 ACTING CHAIR ZIEMER: As I see it 

15 right now, what we're doing with what I have 

16 here is supporting NIOSH's position, and it's 

17 not providing new evidence. For example, it 

18 doesn't talk about major limitations of the 

19 determinations. 

20 I think we're already aware of 

21 those and I don't know whether we need to 

22 discuss them. But I think it is important, 
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1 for example, if we're on record as saying yes, 

2 we agree that CLL should be added and we agree 

3 with the model that's going to be used. Those 

4 two things are very important. 

5 MEMBER MUNN: It's brief. It 

6 addresses all of the questions that are asked 

7 in the docket. Looks fine.

8 MEMBER FIELD: Yes, I agree. I 

9 think you did an excellent job putting this 

10 together.

11 MEMBER LOCKEY: I do too.

12 MEMBER ROESSLER: And I agree too.

13 ACTING CHAIR ZIEMER: So shall we 

14 sort of, I'm wanting to take it by consent 

15 that we're in general agreement with the draft 

16 with the minor editorial changes plus finding 

17 some alternate wording for that first bullet 

18 if needed. 

19 Is that where we stand? Anyone 

20 have heartache with that?

21 MEMBER MUNN: No.

22 MEMBER LOCKEY: No.
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1 MEMBER ROESSLER: None here.

2 ACTING CHAIR ZIEMER: Okay, I'm 

3 going to, unless I hear objection I'll take it 

4 by consent that this will be the basic 

5 document. 

6 We'll change it to a letter to the 

7 Secretary and I guess get some suggested 

8 wording on that first bullet and then we'll 

9 have it, provide a draft. 

10 Ted, when would we need to get the 

11 draft to the Board? Obviously as soon as 

12 possible, but what's the drop-dead date?

13 MR. KATZ: Well, I mean it will be 

14 good to get it to the Board at least a week in 

15 advance of the meeting, but it's not extensive 

16 so I think that would be gracious plenty.

17 ACTING CHAIR ZIEMER: Okay. So 

18 let's ask all of you who have wording 

19 suggestions on that bullet or anything else 

20 that pops into your mind, if you could get 

21 that to me in the next week and then I'll 

22 develop a final document and we'll go from 
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1 there. How will that be?

2 MEMBER FIELD: That sounds great.

3 ACTING CHAIR ZIEMER: Okay? Any 

4 other final comments?

5 MEMBER MUNN: No, good job. Thank 

6 you.

7 ACTING CHAIR ZIEMER: If not 

8 we'll then adjourn the meeting. Thank you all 

9 very much.

10 (Whereupon, the above-entitled 

11 matter went off the record at 2:00 p.m.)

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