1

This transcript of the Advisory Board on Radiation and Worker Health, SEC Issues Work Group,

has been reviewed for concerns under the Privacy Act (5 U.S.C. § 552a) and personally 

identifiable information has been redacted as necessary. The transcript, however, has not been 

reviewed and certified by the Chair of the SEC Issues Work Group for accuracy at this time. The 

reader should be cautioned that this transcript is for information only and is subject to change.

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 

+ + + + +

SEC ISSUES WORK GROUP

+ + + + +

TUESDAY

OCTOBER 28, 2014

+ + + + +

The Work Group convened via 

teleconference at 1:30 p.m., Eastern 

Daylight Time, James M. Melius, Chairman, 

presiding.

PRESENT:

JAMES M. MELIUS, Chairman

GENEVIEVE S. ROESSLER, Member

PAUL L. ZIEMER, Member

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2

This transcript of the Advisory Board on Radiation and Worker Health, SEC Issues Work Group,

has been reviewed for concerns under the Privacy Act (5 U.S.C. § 552a) and personally 

identifiable information has been redacted as necessary. The transcript, however, has not been 

reviewed and certified by the Chair of the SEC Issues Work Group for accuracy at this time. The 

reader should be cautioned that this transcript is for information only and is subject to change.

ALSO PRESENT:

TED KATZ, Designated Federal Official

BOB BARTON, SC&A

NANCY CHALMERS, ORAU Team

HARRY CHMELYNSKI, SC&A

STU HINNEFELD, DCAS

TOM LaBONE, ORAU Team

JENNY LIN, HHS

JOYCE LIPSZTEIN, SC&A

ARJUN MAKHIJANI, SC&A

JOHN MAURO, SC&A

JAMES NETON, DCAS

LaVON RUTHERFORD, DCAS

DANIEL STANCESCU, DCAS

JOHN STIVER, SC&A

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3

This transcript of the Advisory Board on Radiation and Worker Health, SEC Issues Work Group,

has been reviewed for concerns under the Privacy Act (5 U.S.C. § 552a) and personally 

identifiable information has been redacted as necessary. The transcript, however, has not been 

reviewed and certified by the Chair of the SEC Issues Work Group for accuracy at this time. The 

reader should be cautioned that this transcript is for information only and is subject to change.

T-A-B-L-E O-F C-O-N-T-E-N-T-S

PAGE

Welcome and roll-call/introductions ..... 4

Draft Criteria for the Evaluation and

Use of Internal Exposure Coworker 

Datasets 6

10-Year Review Item; Incorporating

Additional Perspectives into SEC

Decisions .............................. 71

Update on SC&A Review of Savannah

River Site Coworker Model .............. 66

Next steps and Plans for Board Meeting

Discussion ............................. 82

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

2 (1:32 p.m.)

3 MR. KATZ: Welcome, everyone. 

4 This is the Advisory Board on Radiation and 

5 Worker Health. This is SEC Issues Work 

6 Group. For everyone on the line, the 

7 materials that may be discussed today are 

8 posted on the NIOSH website along with the 

9 agenda for the meeting. And that's under the 

10 Board section, scheduled meetings, today's 

11 date.

12 So folks on the line, you can 

13 follow along with the documents to the 

14 extent that they get referenced. I'm not 

15 sure they'll all be referenced today, but 

16 they're there.

17 We're not talking about a 

18 specific work site, so I don't think we need 

19 to address conflict of interest for any of 

20 the Board Members or for staff. So I think 

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1 that covers it.

2 And I already have the Board 

3 Member attendance because I have Dr. Melius, 

4 Chair, and Dr. Roessler, and Dr. Ziemer on 

5 the line. But do we have any other Board 

6 Members that are on the line? Okay. How 

7 about NIOSH/ORAU team?

8 (Roll call)

9 MR. KATZ: Okay then, Jim, it's 

10 your meeting.

11 CHAIRMAN MELIUS: Okay. Welcome, 

12 everybody. This is a continuation of a 

13 meeting we had in, I believe in Idaho Falls 

14 where we were just working on sort of issues 

15 related to coworker data sets. And some of 

16 these were sort of statistical issues that 

17 we had started with some time ago.

18 But we also felt that it was 

19 important to come up with some sort of 

20 broader, more general criteria for the 

21 development of an evaluation of coworker 

22 data sets.

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1 So Jim Neton has been working and 

2 putting together a document on that effect 

3 with input from the Work Group and others to 

4 that. So I expect that we'll spend most of 

5 our time today on the first item here to 

6 that.

7 There are a couple other issues 

8 that are somewhat related to this, the 

9 second and third items on the agenda. And 

10 then I'm not sure how much time we'll have 

11 to get to those, and then we also have, we 

12 just want to, we briefly talked about what 

13 we will do for the Board meeting, which is 

14 coming up very shortly, in fact next week.

15 So I think I'll start by turning 

16 it over to Jim. I believe you're going to 

17 start the presentation and then we'll react 

18 to that as we go through it. I'm not sure 

19 exactly what your plans were.

20 DR. NETON: Sounds good to me. 

21 Okay, I just want to give an update as to 

22 what NIOSH has been about since the meeting 

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1 we had in Idaho.

2 And to start the discussion, well 

3 I've been busy revising the implementation 

4 guide, the draft implementation guide we 

5 talked about at the last Work Group meeting.

6 And then I said in my transmittal 

7 of October 13, my email that I've tried to 

8 incorporate comments from the 250 page 

9 transcript of that meeting as well as some 

10 individual input I received from Dr. Melius 

11 and SC&A.

12 But before I get to that, I want 

13 to talk a little bit about the evaluation 

14 and differences between strata that we 

15 discussed, as well, at the last meeting.

16 If you recall, NIOSH has been 

17 attempting to come up with some alternative 

18 way of determining whether or not data sets 

19 should be stratified. The first path, of 

20 course, was in RPRT-53 that talks about the 

21 Monte Carlo permutation test or the Peto22 Prentice test.

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1 And those are based on purely 

2 statistical criteria. So we set about 

3 trying to look at other ways that might be 

4 employed. And the first task after that, you 

5 remember we looked at the significant 

6 difference in dose, the 100 millirem dose.

7 And we evaluated that. It turned 

8 out 100 millirem didn't make any difference 

9 in the PC for all the cases we evaluated. 

10 But that didn't seem to go anywhere as well.

11 And then we put forth the concept 

12 on looking at the 95th percentile that we 

13 would assign for a heavily exposed worker 

14 versus applying the coworker model, a full 

15 distribution of that coworker model if the 

16 data were indeed stratified and more 

17 representative of that worker population.

18 I've got up in our Live Meeting 

19 here just to refresh everybody's memory, the 

20 short report that Daniel Stancescu and I put 

21 out on July 7 which kind of went through the 

22 basis of that.

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1 And at the end result, I would 

2 just like to go back to the table that we 

3 generated which showed that, at least in our 

4 mind, that it would take at least a factor 

5 of two difference in the geometric mean of 

6 the stratified model to be more claimant7 favorable than just merely assigning a 95th 

8 percentile.

9 That seemed to be pretty solid. 

10 And I don't know if you can all see the 

11 Table 1 that's on Live Meeting, but we 

12 evaluated all the cancers that have IREP 

13 models.

14 And they range anywhere from the 

15 geometric mean difference of 4.1 all the way 

16 down to the lowest value which was 2.07 that 

17 covered the urinary organs excluding the 

18 bladder. So that was sort of the worst case 

19 scenario in our mind. It would be at least 

20 a factor of 2 difference.

21 Now just to refresh everyone's 

22 memory, again the --

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1 MEMBER ZIEMER: Can I interrupt? 

2 I'm not seeing anything on live meeting.

3 DR. NETON: Okay. Can anyone see 

4 it?

5 MEMBER ROESSLER: I'm not there 

6 yet. I'm still trying to get on.

7 (Simultaneous speaking.)

8 MR. KATZ: No, Jim, nothing's 

9 showing.

10 CHAIRMAN MELIUS: Okay. I 

11 thought it was just me.

12 DR. LIPSZTEIN: No, nothing is 

13 showing.

14 MEMBER ZIEMER: I saw something 

15 momentarily, it looked like your cover 

16 sheet. And then it's disappeared again.

17 DR. NETON: Okay, my desktop is 

18 off. Okay, is my desktop up there now?

19 MR. KATZ: Yes.

20 MEMBER ZIEMER: I see the 

21 desktop.

22 DR. NETON: I should be able to 

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1 just start this Word document, should show 

2 up, right?

3 MR. KATZ: Yes, it should.

4 DR. NETON: Okay. Is it there?

5 MR. KATZ: Yes, yes.

6 MEMBER ZIEMER: The cover sheet 

7 is there.

8 DR. NETON: Yes, this is the 

9 first page of the document. This is a Word 

10 document. I just wanted to scroll down 

11 through the Table 1 to refresh everyone's 

12 memory that, you know, we evaluated each 

13 individual cancer model.

14 And this was to determine, you 

15 know, what difference, it would have to be a 

16 geometric means for the stratified coworker 

17 model to me more claimant-favorable than 

18 just applying a 95th percentile of the 

19 distribution.

20 And it ranged all the way from 

21 female genitalia that had a geometric mean 

22 of 4.1 all the way down to the last cancer 

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1 model you should see on this page which was 

2 urinary organs excluding the bladder. And 

3 that geometric mean difference was 2.07.

4 That made at least me feel pretty 

5 comfortable that this may have some 

6 viability for looking at, you know, what 

7 needs to be stratified. But I did say in 

8 the report that it was preliminary. We used 

9 alpha exposure because in my mind, first, 

10 that's the dose that really, that's a big 

11 dose getter in our program.

12 I mean, most of the compensation 

13 cases, largely evolved alpha exposure to one 

14 of the either lungs or one of what we call 

15 the metabolic organs, the organs that tend 

16 to concentrate the alpha emitting material.

17 So that was the reason we did 

18 that, plus the alpha radiation effectiveness 

19 factor had a very widespread distribution, 

20 more widespread than any of the other 

21 radiation effectiveness factors.

22 Well, just to be sure we cover 

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1 all of our bases, we went and evaluated how 

2 this applied for all the other radiation 

3 types that we use in IREP. And there should 

4 be another table on the screen. Is it 

5 there?

6 MR. KATZ: Yes.

7 DR. NETON: Okay. And this is a 

8 re-analysis of that last model where for 

9 urinary, bladder excluding, this one here, 

10 urinary organs excluding the bladder. And 

11 what this is, the first line is exactly the 

12 last line of the previous report that I had 

13 on the screen where you see a geometric mean 

14 of 2.07.

15 And that indeed is exactly the 

16 number we got before, and it is for alpha 

17 exposures. But what's interesting about 

18 this, I'm not sure I completely understand 

19 why, for radiation type exposures that have 

20 smaller uncertainty in the radiation 

21 effectiveness factors, for example photons 

22 are greater than 250 which actually have no 

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1 radiation effectiveness factor contribution, 

2 the value is much smaller than two.

3 And in all cases, these values 

4 are smaller than the one that we received 

5 from the alpha, which brings this down to 

6 the point where I'm not convinced that this 

7 approach is viable anymore. I think I 

8 communicated that in the email.

9 It's certainly the case that for 

10 alpha emitters, it's going to be a factor of 

11 two higher if you use the 95th percentile 

12 than the geometric mean full distribution. 

13 But anyway, I just talked about this earlier 

14 because this going to affect our discussion 

15 of Section 4 of the document.

16 I just don't see, I can't think 

17 of any way that this is going to be a real 

18 useful litmus test for determining whether 

19 something should be stratified or not.

20 Okay, so now let's get on to the 

21 revisions of the document, unless there's 

22 any questions on that. Okay, I don't hear 

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1 any.

2 So I thought the easiest way, and 

3 I'm willing and open to suggestions, to go 

4 through the revision is actually just go 

5 through the track changes version on the 

6 screen here so that it would be pretty easy 

7 to see what changed from Rev, the first 

8 revisions we're calling Rev 1. And now 

9 we're at Revision 2.

10 Again, I mentioned that this 

11 incorporates, I feel to a large extent as 

12 much as possible, I think, the comments that 

13 I received at the working group meeting as 

14 well as SG&A sent a nice memo over.

15 In their transmittal, I believe I 

16 got the sense that we were largely in 

17 agreement on most of the issues. And we'll 

18 see how that plays out after our discussion, 

19 though.

20 So the introduction remains 

21 pretty much the same. That just sets the 

22 stage for, you know, why we are doing 

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1 coworker models and what sort of gives us 

2 the authority to do that in the regulation 

3 under Section 82.2. Not much changed there.

4 Section 2 gets into the criteria 

5 for evaluation of adequacy and completeness 

6 of the model. I've added some information 

7 here to make it clear that when we're 

8 talking about adequacy of the data, we're 

9 really talking about the technical adequacy, 

10 and is it technically capable of evaluating 

11 the workers' intakes versus the completeness 

12 which is we have, you know, what fraction of 

13 workers were monitored, if the right 

14 fraction were monitored, do we have all the 

15 data that we think we had. So that was some 

16 change in there.

17 I tried to beef up the adequacy a 

18 little bit. I know there was some 

19 discussions about an appendix with a lot 

20 more detail. I really couldn't see that it 

21 fit in here, so I just beefed up the 

22 language a little more to include a few more 

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1 items such as what's useful for, you know, 

2 what is a valid sample, either bioassay 

3 examples or personal dosimeter measurements.

4 I have a footnote in here that it 

5 allows for breathing zone air samples if 

6 they were taken, and found to be acceptable, 

7 okay. I added some information about scaling 

8 factors, if you had a radionuclides that 

9 were in a combination decision activation 

10 proxy to really clearly understand the ratio 

11 of the components in those materials.

12 And talked a little bit about 

13 technology shortfall, how they need to be 

14 corrected, the measure needs to be corrected 

15 to establish the model. So really, this is 

16 all about how the data technically is 

17 capable of measuring what they purport to 

18 do.

19 A little further down I talk 

20 about the collection, were blank samples 

21 run, and a little bit about precision. This 

22 came up in one of the reviews, I think, of 

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1 Savannah River.

2 If you have blank, multiple 

3 samples taken on the same individual in the 

4 same time frame, you need to have 

5 demonstration of the data fairly precise. 

6 Not just accurate but repeated measures 

7 produce in general the same value within a 

8 certain tolerance.

9 A little write up in here about 

10 how chelation therapy should not be used. I 

11 mean, data that were taken as a direct 

12 result of chelation therapy are probably not 

13 useful for coworker models. So just some 

14 more information in there about the adequacy 

15 of the data. Completeness, I added quite a 

16 bit of material.

17 CHAIRMAN MELIUS: Jim, can we 

18 just stop there and see if anybody has any 

19 comments or questions? It's easier I think 

20 if we go through section by section just 

21 like we did before. And I actually don't 

22 have any on that. But I thought the level 

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1 of detail was about appropriate.

2 I mean, just see it becomes a, 

3 you know, a multi-chapter book, it just 

4 becomes a paragraph. And I think the 

5 paragraph, what you have here is fine. But 

6 I don't know if others have comments. Paul 

7 or Gen?

8 MEMBER ZIEMER: This is Ziemer. 

9 I have no comments on this section. I think 

10 it's fine. I think the level of detail is 

11 appropriate for kind of giving the overview 

12 of what's needed in data adequacy.

13 MEMBER ROESSLER: I'm okay.

14 MR. BARTON: This is Bob Barton 

15 with SC&A. I had one thought about it, and 

16 it's kind of related to the chelation agents 

17 like EDTA. I mean, SC&A certainly agrees 

18 that it's not really appropriate to plug 

19 that value in as if it really represents 

20 what a normal excretion pattern would be.

21 At the same time, the reason the 

22 worker would be administered such a thing 

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1 would be because they're involved in some 

2 sort of incident and they're trying to, you 

3 know, sort of flush their system.

4 So I was just curious if NIOSH 

5 had given any thought as to how those 

6 incidents might be handled because again, 

7 those workers who were administered that 

8 sort of represent, you know, acute intakes 

9 that were significantly high in most cases.

10 And while it's correct to pull 

11 them out of any sort of coworker model 

12 because it's not about representative data 

13 point, we're sort of losing that, I guess, 

14 angle on potential exposures that maybe 

15 weren't necessarily caught, maybe not all 

16 the workers who were involved were 

17 administered the chelating agent, but then 

18 we're sort of losing those samples that sort 

19 of characterize what that incident might 

20 have been.

21 I was just curious if there's 

22 been any discussion or thoughts on that.

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1 DR. NETON: Well, I guess my 

2 opinion there is that if, you know, and we 

3 could talk about this more as we go along, 

4 but if the coworker model is being developed 

5 based on what we would consider routine 

6 exposures, incidents more than likely don't 

7 belong in there.

8 I think we can tolerate some 

9 incidents in there, they will tend to bias 

10 results high. But when you start 

11 incorporating people who have accumulated, 

12 you have abnormally high excretion patterns 

13 which would really seriously bias the 

14 models.

15 So I don't think they should be 

16 in there. How we would handle the 

17 individual incident I think is not really a 

18 subject of this document.

19 There are techniques that one 

20 can, you know, use and I strongly suspect 

21 that people that were chelated have 

22 multiple, multiple bioassay samples that 

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1 cover a long period of time that we would 

2 use to reconstruct their dose if they were a 

3 claimant.

4 But again, I think that's sort of 

5 out of the scope of what we're trying to 

6 accomplish here in this document. That's my 

7 off the top of the head thoughts.

8 DR. LIPSZTEIN: May I?

9 DR. NETON: Yes.

10 DR. LIPSZTEIN: Hi. I tend to 

11 agree with you because actually the models 

12 won't work if the person had some therapy.

13 So you are trying to apply a 

14 model that will give you the intake for 

15 people that were unmonitored. So you can't 

16 use the data from people that were chelated. 

17 So I agree with it.

18 I have one more comment on the 

19 data adequacy, but it's just a small detail. 

20 It's that on the first paragraph, everything 

21 that's talked about, it's like if the only 

22 coworker models were developed for urine 

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1 bioassay samples instead of also for whole 

2 body counting for in vivo monitoring.

3 So I would add something about 

4 items to be considered like calibration of 

5 the counter and also evaluation, monitoring 

6 the progeny, and significant difference 

7 between the biokinetic behavior of progeny.

8 DR. NETON: That's a very good 

9 comment, Joyce. That definitely needs to be 

10 in there. I guess I, you know, we don't do 

11 that many coworker models for whole body 

12 counting or in vivo counting, but we do. 

13 And I agree. I think, you know, benefit 

14 from having discussion of that.

15 Plus, you are experienced with 

16 lung counting for thorium and a big topic of 

17 debate as far as coworker models go. Yes, 

18 good comment. Okay, any more comments on 

19 2.1? If not, we'll move on. All right, 

20 hearing none.

21 This is data completeness. And 

22 so of course, once we've evaluated and we 

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1 passed the bar, the threshold that says the 

2 data are technically acceptable, we need to 

3 determine, you know, are they useful for 

4 bounding the population that we're trying to 

5 reconstruct?

6 And I don't know if I made this 

7 term up, but I've definitely called this a 

8 gap analysis that's come up in our 

9 conversations. We need to look at what data 

10 collected and on who the data were 

11 collected.

12 The number of monitoring samples 

13 for each category should be compared to the 

14 total number of workers, although that's not 

15 always possible because oftentimes when we 

16 get a data set, we don't have, the data set 

17 doesn't have job categories. And sometimes 

18 we don't know the total number of workers 

19 who were exposed in that job category 

20 anyway.

21 But if the data are there, it 

22 certainly is something that should be done. 

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1 We've added here that job category does not 

2 have to be an individual job title. It 

3 could be a category that consists of several 

4 job titles. But you'd have to establish 

5 that the exposure of those categories would 

6 be similar.

7 I've added a paragraph here. It 

8 says that if the number of workers in each 

9 category is unknown, it's useful to 

10 sometimes use the NOCTS data, the data that 

11 we have on claimants.

12 This came about in our discussion 

13 about the Nevada Test Site with their 

14 example of this where I think we had a large 

15 number of monitoring data points for folks. 

16 I think it was something like 300 people 

17 that were monitored. 

18 But fully two thirds of those, I 

19 think, that table below, two thirds of those 

20 were radiation safety staff. So it kind of 

21 gives you some pause to think about is that 

22 really representative of the exposure 

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1 potentials considering we had laborers, 

2 welders, and miners who were certainly in 

3 exposure conditions that were equal to if 

4 not greater than the rad safety staff.

5 You know, it's a good example of 

6 what to think about when you parse the data 

7 out by job categories to see if the right 

8 people were monitored. So I've added this 

9 paragraph in here to cover that.

10 Any time there are gaps, 

11 sometimes we have gaps where we have no 

12 monitoring data, it needs to be investigated 

13 why. What are we missing? I think this 

14 happened at least one site, I can't think of 

15 the name, where there's four or five years 

16 there's just no monitoring data.

17 You know, is it just lost, was it 

18 taken, or was there some sort of an outage 

19 where they weren't working with radioactive 

20 materials? They need to be evaluated and 

21 explained in some way.

22 Just added a little bit about how 

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1 the number, I discretely identified 

2 activities will vary widely. There's not 

3 much uniformity among these sites, 

4 particularly the differences between AWEs 

5 that sometimes give one very specific task 

6 versus the large, multi-purpose DOE 

7 facilities that they had a lot of different 

8 operations. So that needed to be taken into 

9 consideration when you're looking at the 

10 completeness of the monitoring programs.

11 Talk about a little bit of the 

12 minimum number of data points, and we 

13 bounced around with this idea of 30. But 

14 that's certainly not a hard and fast rule. 

15 We tried to point out where there may be six 

16 workers involved and the manipulation of 

17 parts in a glove box.

18 And if you have three workers 

19 that were monitored, that may be enough for 

20 that operation. So it's sort of just trying 

21 to point out that there are no real hard and 

22 fast rules here. Each situation needs to be 

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1 monitored on a case by case basis.

2 And the last paragraph here, 

3 which I think could be expanded on but I 

4 think it's pretty important even though it's 

5 short. It talks about if you have summary 

6 databases or electronic records, some effort 

7 needs to be expended to look at, to 

8 determine if those summary databases 

9 actually have all the data.

10 We talked about this before where 

11 maybe these are all the routine samples, and 

12 there are a lot of incident samples stuck in 

13 a drawer somewhere in the medical files. Or 

14 even the routine samples, are they all 

15 there, or have some database manipulation 

16 accidentally removed them?

17 So that needs to be done to make 

18 sure you have an unbiased listing of the 

19 data collected by the site. So that's the 

20 totality of Section 2.2. I'm going to stop 

21 there and you can discuss what's in here?

22 CHAIRMAN MELIUS: Okay. Gen or 

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1 Paul, do you have comments on that section?

2 MEMBER ZIEMER: This is Paul. 

3 I'm okay with Jim's suggested revisions.

4 MEMBER ROESSLER: Yes, and I'm 

5 still trying to get on the Live Meeting. 

6 I've got a new computer. It didn't have 

7 Java installed, so I've gone back to my old 

8 computer. So while I'm doing this, I'm 

9 listening, and from what I've heard, I don't 

10 have any comments.

11 DR. NETON: Well Gen, this is, if 

12 you have the documents I sent last week or 

13 so, I'm just going through the track changes 

14 version.

15 MEMBER ROESSLER: Yes. And you 

16 probably, I don't see them on, I've been on 

17 travel and I haven't opened my Government 

18 computer for about a week. So I --

19 DR. NETON: I sent them out on 

20 the 13th, if that helps.

21 MEMBER ROESSLER: Okay. It says 

22 now, you are now connecting to the meeting, 

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1 so maybe I'm going to be good.

2 DR. NETON: Okay.

3 MEMBER ROESSLER: We'll see. 

4 Otherwise, I'll check my emails.

5 DR. NETON: Okay. And I believe 

6 they're also on the website.

7 MEMBER ROESSLER: I didn't see 

8 them on the website.

9 CHAIRMAN MELIUS: I don't think, 

10 they weren't on the website when I looked 

11 this morning.

12 DR. NETON: They haven't gotten 

13 there yet?

14 MEMBER ROESSLER: No, I didn't 

15 find that. I just found the SG&A documents.

16 DR. NETON: Okay.

17 CHAIRMAN MELIUS: I have a couple 

18 of comments. One is sort of, you sort of 

19 cover it later. But I think some comment 

20 here under data completeness, to the effect 

21 that you're usually trying to focus on sort 

22 of annual, you know, what data's complete 

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1 for a given year, because that's usually the 

2 most sort of reasonable way of approaching 

3 it in terms of how you've collected 

4 information.

5 You cover it later, but I think 

6 it's something someone would do if they're, 

7 you know, initially starting out looking at 

8 data completeness. So maybe, you know, just 

9 a mention of that there.

10 The other area that came up that 

11 I think is important is people are sort of 

12 doing the gap analysis and looking for sort 

13 of, you know, potential stratification or 

14 couldn't it be different types of exposure 

15 for people with different job titles or 

16 whatever.

17 But I think one of the other 

18 things that's important, again we talked 

19 about before, was sort of sufficient 

20 accuracy.

21 It's sort of what's the absolute 

22 level of exposure that, you know, you're 

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1 going to be more concerned about a high 

2 exposure job and as opposed to something 

3 where it's environmental exposure around the 

4 site or something like that where we know 

5 that there's not much contribution to a 

6 person's dose from that exposure.

7 And I would think that's, I mean, 

8 I think you generally do it because I think 

9 you want to focus on, you know, sort of the 

10 higher risk exposures. But I think 

11 mentioning it here, I mean, I think it makes 

12 some difference in terms of the number of 

13 samples that might be required and how 

14 comfortable you would be with a smaller data 

15 set or a less complete data set. Does that 

16 make sense to you, Jim?

17 DR. NETON: Yes, it does. I do 

18 talk about it a little bit later, but it 

19 would make sense when you're looking at 

20 completeness.

21 CHAIRMAN MELIUS: I'm just saying 

22 someone sort of going through this step wise 

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1 or evaluation and so forth. And that last 

2 paragraph here I thought was very good. I 

3 think it was really, really helpful for, you 

4 know, sort of going through and sort of 

5 thinking about what needs to be done there. 

6 So I would just there, I would if anything 

7 consider on expanding that a little bit.

8 MEMBER ROESSLER: Jim, this is 

9 Gen. I think I'm there now. I see a marked 

10 up copy. So I should be able to follow from 

11 here on.

12 CHAIRMAN MELIUS: Actually, I was 

13 referring to the last two paragraphs. So 

14 it's those two paragraphs at the end that I 

15 think need to be, I think are good and I 

16 thought were helpful. So just to reinforce 

17 what you said.

18 DR. NETON: Very good.

19 MEMBER ZIEMER: Jim, this is 

20 Ziemer. What last two paragraphs were you 

21 referring to, the revised one?

22 CHAIRMAN MELIUS: In the revised 

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1 --

2 MEMBER ZIEMER: The revision of 

3 2.3?

4 CHAIRMAN MELIUS: No, no, 2.2 

5 just above --

6 MEMBER ZIEMER: Oh, you haven't 

7 begun 2.3?

8 CHAIRMAN MELIUS: Yes.

9 MEMBER ZIEMER: Yes, yes. Okay, 

10 the new paragraph?

11 CHAIRMAN MELIUS: Yes.

12 MEMBER ZIEMER: Right, okay. I'm 

13 good on that, yes.

14 CHAIRMAN MELIUS: Yes.

15 DR. CHMELYNSKI: This is Harry 

16 Chmelynski. I have one comment about the 

17 way it's phrased in terms of the 30 samples. 

18 I would like to have it made more clear that 

19 that's for each of the groups if you're 

20 doing stratification.

21 DR. NETON: Yes. I was just 

22 implying, but it just wouldn't be hard to 

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1 make sure that's emphasized.

2 DR. CHMELYNSKI: It might be in 

3 there. It doesn't jump out at you.

4 DR. NETON: No, I don't think 

5 it's in there. I think I just sort of, you 

6 know, I'm close to it and I'm assuming 

7 that's what we were talking about. But it 

8 would be a minimum of 30 samples per 

9 monitoring interval or whatever, I guess, or 

10 something like that.

11 DR. CHMELYNSKI: Well, that's the 

12 phrasing there now at. It's just a little 

13 unclear exactly what that means.

14 DR. NETON: Yes. Our lawyers 

15 were asking that same question.

16 (Simultaneous speaking.)

17 CHAIRMAN MELIUS: Is that why you 

18 got a new lawyer?

19 DR. NETON: I think by monitored 

20 interval or evaluated interval, I was really 

21 trying to, you know, there's a generic term 

22 for, I was just kind of saying on a year by 

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1 year basis or quarter by quarter basis, you 

2 know.

3 DR. CHMELYNSKI: Right. I

4 understand the temporal implication. But in 

5 terms of stratification, that doesn't 

6 clearly mean what's in that phrase.

7 DR. NETON: Yes, I can fix that.

8 DR. MAKHIJANI: Jim, this is 

9 Arjun. I think Harry also meant that these 

10 are samples for each group, each of the two 

11 groups being compared?

12 DR. CHMELYNSKI: Yes.

13 DR. NETON: Yes.

14 DR. MAKHIJANI: So that should I 

15 think also be clear.

16 DR. NETON: Well, I would say for 

17 each group that's being reconstructed, I 

18 mean, I'm not really talking about comparing 

19 at this point. And that's something that 

20 we're going to talk about later, although I 

21 can bring this up now I guess is that the 

22 way this is written here so far is if, well 

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1 actually I'm going to get to it more in 2.3.

2 But the idea is if you have 

3 reason to believe, if a person has reason to 

4 believe that the monitoring programs don't 

5 match up, say it's pretty clear that you 

6 have a mismatch of a routine monitoring 

7 program for this category worker and an 

8 incident based monitoring program for 

9 Category B workers.

10 And they're never going to be 

11 matched up. There's no real reason to 

12 compare those at all. I think they should 

13 be stratified from the get-go because, you 

14 know, you've identified, you've got the job 

15 categories, you know the monitoring programs 

16 are just similar.

17 There's no reason to mesh those 

18 two into one group and then start doing some 

19 statistical analyses on them. It just 

20 doesn't make any sense.

21 I think that, by and large, 

22 applies to most categories where if you've, 

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1 if you have a priori reason to believe that 

2 they're different and you have the ability 

3 to segregate them or separate them, I think 

4 it just should be done.

5 DR. MAKHIJANI: Okay, I see what 

6 you mean. Okay. That's much clearer now.

7 DR. NETON: Maybe that represents 

8 a bit of a change on our part, but you know, 

9 the more I delve into this, it's like well 

10 if you've got the data and you think they're 

11 different, well just go ahead and do it and 

12 let the data fall where they may. It avoids 

13 a lot of analysis, unnecessary analysis. 

14 Okay.

15 MR. BARTON: This is Bob Barton. 

16 There was one in this section. It has to do 

17 with this notion of evaluation periods. And 

18 normally that's, you know, one year that you 

19 calculate your OPOS value or if you have the 

20 data to do quarters then, you know, you 

21 prefer to do it as fine as possible, 

22 certainly.

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1 But another consideration that we 

2 might want to think about is establishing 

3 these evaluation periods on more of a 

4 campaign basis. You know, for example if 

5 you had two years, we'll just arbitrarily 

6 say 1991 and 1992.

7 And starting in July of '91 you 

8 had shifts in a campaign for, you know, 

9 uranium processing, whatever it might be, 

10 you might want to consider breaking it up 

11 really based on operational procedures and 

12 not just a time period such as January to 

13 December of a certain year. To the extent 

14 that that's feasible I think we should look 

15 into it.

16 DR. NETON: Yes, I think maybe 

17 it's implied in here, at least in my mind. 

18 You know, a year is a convenient interval, 

19 and oftentimes not much changes in a year at 

20 a big facility.

21 But I agree with you. I mean, if 

22 there was some obvious, major change in 

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1 process or equipment or whatever and it 

2 happened in the middle of the year, yes 

3 there's no valid reason to lump those all 

4 into one.

5 I think that's sort of a given. 

6 But you're right, it's not explicitly stated 

7 here. Let's talk about that when you get 

8 into period longer than one year, but it 

9 doesn't call out period less than a year. 

10 Yes, that could be clarified a little bit. 

11 I wouldn't have a problem putting some 

12 language in there on that.

13 Okay. Anything else on 2.2? 

14 Okay. All right, this 2.3, applicability of 

15 monitoring data to the unmonitored workers 

16 really sort of gets into the meat of the 

17 issue which is what type of monitoring 

18 programs are we looking at.

19 And you know, nothing changed 

20 here about the three major types. You know, 

21 routine representative of the workers, 

22 routine with the highest exposure potential, 

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1 and collection of incident samples.

2 Let's see. I talk a little bit 

3 about how establishing the basis for the 

4 program participation, you know, what type 

5 of program was this would require. And it 

6 should involve a review of the site's 

7 radiological control program documentation.

8 I mean, that's where the tone is 

9 set as to how we select people for 

10 monitoring and how frequently they're going 

11 to be monitored. But nonetheless, even if 

12 you have a very good feel that the program 

13 meant to do it, I think I put in here 

14 somewhere that you need to follow up.

15 One needs to follow up and make 

16 sure that they actually did that. There are 

17 some cases where the site meant well, and 

18 we've seen evidence that people were not 

19 participating, either because it was 

20 voluntary and it was not really, you know, 

21 followed up on or for whatever reason. So 

22 that was added into this section.

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1 This paragraph I'm highlighting 

2 here is something that we thought about 

3 which is a little bit, sort of a variation 

4 in my mind of a routine monitoring program 

5 where you have, you know, short duration 

6 projects for example where you'll be doing 

7 some sort of an operation and only occur for 

8 a three month period.

9 It may be okay just to have one 

10 sample at the end of that project, and so to 

11 allow for that. I just wanted to make sure 

12 that, you know, this wouldn't have been 

13 precluded because it's not really a routine 

14 program. It's sort of a project specific 

15 program.

16 Those happen from time to time, 

17 particularly at the larger DOE facilities, 

18 and very often at the national laboratories. 

19 So I added that in there.

20 This section here talks about 

21 incident driven samples, let's see. Yes, I 

22 mentioned this before, how I really have 

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1 come to the opinion that it's very hard to 

2 justify intermixing incident driven, workers 

3 who are only on an incident driven program 

4 versus workers who are on a routine 

5 monitoring program.

6 I think it's very hard to mix 

7 those two together and justify it. And that 

8 doesn't mean that the incident driven 

9 population couldn't be modeled somehow, and 

10 we talked about that at the last meeting, 

11 although there are some pretty stringent 

12 criteria that would have to be in place for 

13 that to occur.

14 But nonetheless, I do agree that 

15 combining incident and routine monitoring 

16 programs into one coworker general model is 

17 problematic. So that covers the additions 

18 for Section 2.3.

19 MR. BARTON: Jim, when we talk 

20 about that, sort of the example you gave was 

21 the three month short duration program, you 

22 know, maybe a subcontractor was called and 

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1 doing demolition work or something.

2 And all you have is a sample, 

3 perhaps at the end of the project. As I was 

4 reading through your write up, I sort of got 

5 the impression, would we then be looking to 

6 almost stratify where we're going to 

7 reconstruct doses for that individual who 

8 was only there for three months using those 

9 end of project values and that would be sort 

10 of a separate model aside from the general, 

11 chronic coworker model, or how would that be 

12 handled?

13 DR. NETON: I think at that level 

14 of detail, yes you would. But I guess in 

15 reality, I guess I can't see that happening 

16 too often. You know, you would have to look 

17 at it on a case by case basis.

18 But say it was a three month 

19 project and you had, I don't know, 50 

20 workers on the project. Let's say they 

21 happened to be trace, building trades 

22 workers. I think it would be okay.

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1 You would evaluate the 50 

2 monitored workers. Then you would have to 

3 see based on what occurred in that three 

4 month interval what processes, you know, 

5 were involved.

6 Did you really even need a 

7 coworker model, you know, were the workers 

8 that weren't monitored exposed and that sort 

9 of thing. I mean, you have to look at it on 

10 a case by case basis.

11 I just wanted to leave the door 

12 open for that. I think there are situations 

13 like this, maybe at Savannah River, where we 

14 have a fine amount, a lot of detail on 

15 projects, project specific bioassay for some 

16 what I consider the more exotic 

17 radionuclides when you get into things like 

18 the neptunium and stuff that might have been 

19 campaign driven. It's a long answer, but I 

20 guess the answer --

21 (Simultaneous speaking.)

22 CHAIRMAN MELIUS: This is Jim 

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1 Melius. I mean, I agree with your answer, 

2 Jim. I think it's, yes, I think what we've 

3 learned in this program is that it's all, 

4 every site is different.

5 It's always sort of case by case 

6 and I don't think it hurts to leave open 

7 where my people are this is a possibility so 

8 that we don't sort of arbitrarily rule out 

9 doing it without, you know, thinking about 

10 it and examining the particular situation.

11 Yes, but it's always going to 

12 fall back on, you know, will the 

13 circumstance, are there enough, is the 

14 record keeping adequate to be able to 

15 utilize that approach. But you don't know 

16 until you look.

17 MEMBER ZIEMER: This is Ziemer. 

18 I agree with that. I think it makes sense 

19 to at least have that possibility in the 

20 text here. It may occur only rarely, but it 

21 may very well be needed in the future.

22 CHAIRMAN MELIUS: Anybody else 

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1 with comments on this section? Okay, 3.

2 DR. NETON: Okay. 3.0 which is 

3 the analysis of the monitoring data. This 

4 is sort of just a nuts and bolts section to 

5 allow for what was sort of to include what 

6 we do as a matter of course with these 

7 models.

8 Once we decided we can develop a 

9 model, we have enough data that's valid, we 

10 do generate these statistical distributions, 

11 they're fitted. I have in here allow for 

12 either log normal or we haven't done many 

13 Weibulls, but Weibull is an option. As long 

14 as it fits the data set, I think it's a 

15 valid selection.

16 I'm again, this is from the last 

17 time, the 95th percentile will be used as an 

18 upper bound for highly exposed individuals 

19 if the data aren't stratified. Then I've 

20 added a paragraph here to talk about OPOS, 

21 which I think we're sort of okay with. We 

22 can talk about this more.

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1 But using a backward integrated, 

2 time weighted average analysis for the data 

3 set, and that's been included in the new Rev 

4 2 of RPRT-53. So that's really just was 

5 added into this section.

6 So we want to talk about this 

7 here, or we could talk about it in the 

8 context of RPRT-53. Either way is fine with 

9 me. But I got the sense from SC&A's memo 

10 that they issued not too long ago that they 

11 didn't have any serious problems with a 

12 backward integration time weighted average 

13 approach. Seems to me to make a lot of 

14 sense.

15 MEMBER ZIEMER: Yes, this is 

16 Ziemer. I wanted to ask that question. It 

17 was my impression that this met the SC&A's 

18 comment. But if SC&A can weigh in on that?

19 DR. LIPSZTEIN: May I?

20 CHAIRMAN MELIUS: Yes.

21 DR. LIPSZTEIN: I think that the 

22 backwards time weighted OPOS is very good 

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1 improvement on the coworker models. So I 

2 think we are good on that.

3 MR. BARTON: Yes, this is Bob. 

4 We've had some pretty extensive discussions 

5 on this, and I think where we finally came 

6 out to on SC&A's side was that the pre7 weighted, that is we're going to weight the 

8 sample by the number of data that preceded 

9 it, was really the best option on the table.

10 I think everyone agreed that if 

11 we had the resources and the time to do it, 

12 we would go in and do best estimate intake 

13 calculations and form our distribution based 

14 on that.

15 But based on the discussions we 

16 at SC&A have had, I echo Joyce's sentiment. 

17 We think it's really the best option that's 

18 currently on the table.

19 DR. NETON: That's good news. 

20 That's good to hear.

21 CHAIRMAN MELIUS: Can I just 

22 bring it back because I didn't realize until 

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1 I looked at the website that there was a 

2 revision to this ORAU document out. I 

3 somehow violated the password police at CDC 

4 and haven't been able to get online there.

5 But I don't know if, well, other 

6 Members of the Work Group or SC&A was aware 

7 of the revision?

8 MEMBER ROESSLER: Is this the one 

9 that came out October 8th or something like 

10 that?

11 CHAIRMAN MELIUS: Well, I see a 

12 DOE review release October 16th.

13 DR. NETON: Yes, that's fairly 

14 recent, and to my, I'm reasonably sure that 

15 the only things that were added were the 

16 OPOS backwards integration, time weighted 

17 average.

18 CHAIRMAN MELIUS: Okay.

19 DR. NETON: And we also added a 

20 section on how to evaluate the use of 

21 negative values. Negative values are not 

22 used in the backward integration 

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1 calculation.

2 CHAIRMAN MELIUS: Okay.

3 DR. NETON: And there's various 

4 reasons for that. I'm not sure I want to go 

5 into them today.

6 CHAIRMAN MELIUS: Okay.

7 DR. NETON: We could probably 

8 review that in the context of RPRT-53 

9 because I didn't mention that in here, I 

10 just sort of referenced 53 because it was 

11 easier to reference a document than to 

12 explain exactly what we're doing.

13 And since this is a guide, I 

14 thought it would be better to just reference 

15 RPRT-53.

16 MEMBER ZIEMER: Is that the 

17 October 8th version?

18 CHAIRMAN MELIUS: It's an October 

19 8th version and --

20 DR. NETON: It's been released. 

21 It's okay for public release now. SC&A 

22 asked for a copy because they saw I had 

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1 referenced Revision 2 in this draft. And I 

2 could only, at that time, release the, well 

3 I released it but it hadn't cleared DOE ADC 

4 review at that point.

5 MEMBER ZIEMER: Okay. But Ted 

6 sent this out to us last week, I think.

7 MR. KATZ: Right. But I think if 

8 Jim couldn't get into his CDC account, he 

9 couldn't have picked it up.

10 MEMBER ZIEMER: Oh, okay.

11 DR. NETON: Yes, and the non-ADC 

12 reviewed document couldn't view anywhere but 

13 CDC accounts.

14 MR. KATZ: Yes.

15 DR. NETON: Okay, but it's out 

16 there. And again, I think those are, Tom 

17 LaBone can correct me if I'm wrong, but I 

18 think those are the only two changes of any 

19 substance in Revision 2. Is that right, 

20 Tom?

21 MR. LABONE: Yes, those are the 

22 only changes.

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1 DR. NETON: Yes, okay. I guess 

2 maybe we jumped the gun a little bit, but I 

3 was pretty confident that SC&A was on board 

4 with the backwards integration.

5 CHAIRMAN MELIUS: Now we know, so 

6 we're --

7 DR. NETON: So we're good to go 

8 there. If there's no more discussion on 

9 3.0, I can go into 3.1 which will be pretty 

10 brief.

11 MEMBER ROESSLER: You want to 

12 make a correction, just a typo thing?

13 DR. NETON: Sure.

14 MEMBER ROESSLER: Up there, go 

15 down a little bit in your last, down to the 

16 paragraphs where you did a lot of rewriting. 

17 Third sentence, about in the middle there it 

18 says, "the use". Put "the use of" and then 

19 it will be perfect.

20 DR. NETON: Yes, the use of. 

21 Yes, it's amazing how many people look at 

22 this and, you know, your eyes scan over it. 

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1 Thanks. That's good. Okay, the next 

2 section, the time interval, we already sort 

3 of touched on that that we should probably 

4 use the data, the data come in various 

5 flavors. Some are quarterly, most are 

6 annual.

7 And I really didn't change much 

8 in here. But I do say if it's necessary to 

9 go beyond one year, changes in practices 

10 should be evaluated. That was in there 

11 before.

12 I kind of added the last caveat 

13 here that in general, it should not exceed a 

14 five year period unless, I'm not sure I like 

15 this word, but stringent justification. 

16 That reminds me of the surrogate data.

17 But you know, you certainly got 

18 to really think about a time period greater 

19 than five years, and a lot can change in 

20 five year blocks. So one needs to be aware 

21 of that, I think.

22 MR. BARTON: Jim, this is Bob 

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1 Barton. Could I ask where did the number 

2 five come from, because I thought I 

3 remembered from a previous revision of RPRT4 53 that it was, like, it was a three year 

5 interval that was written in there for 

6 combining OPOS values. So I mean, how did 

7 we arrive at the five?

8 DR. NETON: I'm not sure. Which 

9 report did you see the three year in?

10 MR. BARTON: I thought it was 

11 version one of RPRT-53 when it was talking 

12 about strata comparison anyway. And I 

13 believe it was a footnote. I can look that 

14 up and get back to the Work Group. But I 

15 thought that it said three years, and that's 

16 the previous version of RPRT-53.

17 DR. NETON: Yes, I mean, I don't 

18 know. I guess I didn't remember that. This 

19 sort of just was my opinion at the time I 

20 was writing this. I'm not married to three 

21 or five, I just wanted to get the sense in 

22 there that there should be some sort of 

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1 default upper limit without really having to 

2 go to greater lengths to demonstrate that 

3 it's okay.

4 I mean, that's the whole point. 

5 And again, I mean, I'm not married to either 

6 five or three.

7 MR. BARTON: Okay, I understand. 

8 And like we said before --

9 DR. NETON: I take a look --

10 MR. BARTON: It's a case by case 

11 basis. You know, I mean, if it makes sense.

12 DR. NETON: I'll look at 53 and 

13 make sure we're not inconsistent with --

14 MR. BARTON: It might have been 

15 the previous version, I'm not sure.

16 DR. NETON: I don't remember. 

17 I'll take a look, though. It's a good catch 

18 if it is true. We should be consistent 

19 among our documents, that's for sure.

20 MEMBER ZIEMER: This is Ziemer. 

21 If you don't like the word stringent, you've 

22 got a lot of other options. Compelling 

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1 would be another one.

2 DR. NETON: Yes, actually for 

3 some reason, that just popped immediately 

4 into my mind when I was writing this. I've 

5 heard it so many times, I think.

6 MEMBER ZIEMER: The intent's the 

7 same, though.

8 DR. NETON: Yes, you know what 

9 I'm trying to say. Okay, if there's no 

10 comments on that, this Section 4 is where I 

11 think I need the most feedback and work on.

12 If you remember before, I was 

13 trying to build a case for a factor of two 

14 being sort of our cut point for stratifying

15 or not because it would have been more 

16 claimant-favorable.

17 And that's probably still true 

18 because like I say, most of our exposure to 

19 alpha emitters that gets into the 50 percent 

20 range, but it's certainly not universal 

21 based on that analysis I talked about at the 

22 beginning.

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1 So what I've done here is I've 

2 gone back to essentially what RPRT-53 

3 recommended, which is this Monte Carlo 

4 permutation, or Peto-Prentice test.

5 But then I got to thinking, well 

6 because I mentioned in the earlier section 

7 if you have a valid reason for stratifying 

8 based on different monitoring protocols or 

9 different exposure conditions, then I don't 

10 know that any statistical test is really 

11 needed at that point.

12 If it can be done and it meets 

13 all the other criteria that we just talked 

14 about, I'm not sure any statistical test is 

15 necessary. So then I got to thinking well 

16 then do we need the statistical testing. 

17 And I'm really not sure at this point.

18 It seems that one should be able 

19 to test statistically under certain 

20 conditions, but I don't know. I would like 

21 to open that up for discussion.

22 MEMBER ROESSLER: So, Jim, is 

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1 your question at the very beginning do we do 

2 statistical testing or do we not? Or is 

3 there a list of factors that you can put out 

4 there that say here's a situation where we 

5 don't do it? I'm not sure how you're 

6 approaching that.

7 DR. NETON: Yes. Well, you know, 

8 RPRT-53 if you remember outlined a very, I 

9 don't want to say rigorous, but a pretty 

10 prescriptive process as to how one would go 

11 about this.

12 You would take the individual, 

13 let's say it's an annual basis, the data on 

14 an annual basis, stratify on that annual 

15 basis, and then compare the two strata to 

16 see if they were "statistically 

17 significantly different" or statistically 

18 different under some statistical criteria.

19 And if they weren't, then you 

20 wouldn't stratify. Well, you know, the 

21 argument that's been made, and it has some 

22 merit, is that the data oftentimes have such 

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1 large deviations that you would have to have 

2 fairly massive, massive is probably not the 

3 right, very significant, not a good word 

4 either, very large differences between the 

5 two before you would ever detect some 

6 statistical difference, which begs the 

7 question well then is that really the way to 

8 go.

9 In my way of thinking, the way 

10 we've described this now is if you stratify, 

11 if you look for stratification up front 

12 based on valid reasons of differences in job 

13 categories or exposure conditions, then I 

14 don't know. Do you have to do a statistical 

15 test to show they're different?

16 It's sort of an opposite 

17 approach. Do you qualitatively segregate or 

18 separate these data sets and analyze them 

19 and let the chips fall where they may if you 

20 can analyze that, if you have enough data, 

21 or do you segregate them and then look for 

22 statistical differences?

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1 I think I prefer the previous 

2 approach which is if you can do it, do it. 

3 I don't know. I'm really kind of, I'm torn 

4 here as to how to proceed.

5 MEMBER ZIEMER: Jim, you would 

6 have the coworker model for each different 

7 strata then, is that what you're saying. If 

8 you can do a valid stratification to start 

9 with?

10 DR. NETON: Yes. If you can do 

11 it, valid stratification based on job titles 

12 or, I think to a large extent it may end up 

13 being, you know, maybe trade workers, 

14 construction trades that were more incident 

15 based.

16 That doesn't require statistical 

17 testing in my mind. Those are just two 

18 separate monitoring programs, period, two 

19 separate exposure conditions. So you would 

20 have two separate models. I don't know.

21 CHAIRMAN MELIUS: This is Jim 

22 Melius. Again, in the construction versus 

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1 production or, you know, incidents versus 

2 routine sampling, I mean, I think that's, 

3 you're precluded from doing a meaningful 

4 stratification there or appropriate one.

5 I think the question would be 

6 that in other situations where people are 

7 part of the same type of sampling program, 

8 you know, that I think one of the arguments 

9 you would need to have sort of a more robust 

10 data set to be able to base your coworker 

11 model on if you, I mean, depending on 

12 whether you'd stratify or not.

13 I mean, it would affect sort of 

14 the power of your coworker model to predict, 

15 but it really is going to be a case by case 

16 basis. Always our experience has been 

17 recently at least, and I think at least the 

18 ones we spend time on at the Board is that 

19 we don't have adequate data to place people 

20 within these, you know, job titles or 

21 whatever.

22 DR. NETON: That's right. I 

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1 think you're hitting exactly what I was 

2 thinking is let's say we have, you know, a 

3 situation where you have a fairly robust 

4 routine monitoring program. And at a 

5 minimum, you have data on the job titles of 

6 the people who are in NOCTS at least, you 

7 have 1,000 of those.

8 And you can sort of establish 

9 that you have the people that were monitored 

10 seem to be in job categories that had the 

11 highest potential for exposure, you know, in 

12 a routine process.

13 So now you have these unmonitored 

14 workers that clearly would fall in maybe a 

15 different exposure category, but maybe you 

16 don't need to stratify at that point because 

17 you've demonstrated a front that the highest 

18 exposed workers were the ones that were 

19 monitored, and using the 50th percentile 

20 would be totally fine.

21 I don't know. And then you 

22 don't, if you start stratifying down into 

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1 these lower tiered unmonitored workers, then 

2 you end up just basically giving them less 

3 dose. I mean, not that that shouldn't, 

4 maybe it should be done.

5 And maybe that's the point where 

6 you can determine, use the statistics to 

7 decide why it shouldn't be stratified, 

8 something like that.

9 MEMBER ROESSLER: I like this 

10 approach. And I was going to ask you 

11 earlier about it. What I think is going to 

12 be difficult is you're talking about a 

13 verbal or descriptive way of making a 

14 decision rather than something that's, you 

15 know, more statistical.

16 DR. NETON: Yes.

17 MEMBER ROESSLER: It might be 

18 harder to justify. You talk about job 

19 titles. At the start, that sounds like a 

20 good way, but I'm just wondering how that 

21 would work out.

22 DR. NETON: Yes. I don't know. 

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1 Like I say, it's easier for me to think 

2 about the routine operations versus, as Dr. 

3 Melius points out, the sort of subsets of 

4 populations like the trade workers or, you 

5 know, maybe some, I don't know, some workers 

6 that involve project specific exposures, 

7 campaigns that went on for several years 

8 that were different.

9 I'm not sure. This is one of 

10 those situations, and it's almost, like, you 

11 know, until you see it. Maybe I need to go 

12 back and figure out some examples. I think 

13 that might be --

14 CHAIRMAN MELIUS: Yes. I was 

15 going to suggest, I think that would be 

16 helpful. Maybe some of the external 

17 exposure coworker models might, where you 

18 have a larger data set or something. Or 

19 some of the ones where we've done in the 

20 past and have approved that we would need to 

21 look at.

22 DR. NETON: Yes. I think this is 

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1 best handled, I guess, through an example or 

2 several examples of how one might --

3 CHAIRMAN MELIUS: Yes.

4 DR. NETON: -- proceed. Again, I 

5 think routine is one set, and then pulling 

6 out the, sort of, special exposure 

7 populations to identify them and sort of 

8 determining how you're going to handle them 

9 separately.

10 I think there's room for 

11 statistics, of course, in here but I'm 

12 trying to figure out the best, and I 

13 probably need to talk to our folks, too. I 

14 haven't discussed this with them either.

15 CHAIRMAN MELIUS: Yes. Yes. I 

16 think going back to them, where some 

17 examples would be the way to sort of flush 

18 this one out.

19 DR. NETON: Other than that, I 

20 think it seems like we're fairly okay with 

21 the bulk of this document.

22 CHAIRMAN MELIUS: Yes.

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1 DR. NETON: This last piece. And 

2 that makes me feel pretty good. Even though 

3 it's only eight pages, it's been a lot of 

4 work.

5 CHAIRMAN MELIUS: Yes, yes. No, 

6 no.

7 DR. NETON: That's all I had to 

8 say on this.

9 CHAIRMAN MELIUS: Why don't we 

10 just jump to the last item on the agenda. 

11 We'll come back to the other items. But my 

12 thought would be if you want to make some 

13 quick revisions to this or not make quick 

14 revisions to it depending on how busy you 

15 are, that we get this out to the full Board, 

16 anyway, and do it as a presentation for our 

17 Board meeting next week.

18 DR. NETON: Yes. I think that I 

19 probably won't be able to make too many -- I 

20 can, you know, most of them are fairly 

21 straightforward.

22 CHAIRMAN MELIUS: Yes.

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1 DR. NETON: I tried to keep some 

2 decent notes here. I think I can put in 

3 what we talked about that makes some sense. 

4 I won't have the examples, obviously, ready 

5 for Section 4. I'll just flesh that out and 

6 say examples to follow or something. Yes, 

7 and then I can reissue it.

8 CHAIRMAN MELIUS: Yes, if that 

9 gets too, you know, sort of time pressed and 

10 I'm not sure it's worthwhile. It's just I 

11 hate to have you have to respond to the same 

12 comments. We'll forget what you agreed to 

13 also. So we'll be, like, asking you the 

14 same questions.

15 DR. NETON: The transcripts are 

16 going to come out eventually, but --

17 CHAIRMAN MELIUS: Yes, right, I 

18 know. But what would make, you know, 

19 whatever works for you would be fine. And I 

20 think if we had that and get sort of full 

21 input from the Board on it, that then we 

22 could, you know, sort of decide what to do 

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1 going forward.

2 I mean, I think the other 

3 question is, are there issues that either 

4 need to be fleshed out more or that we 

5 haven't thought of, because I think this, 

6 you know, this approach has, or our thoughts 

7 about this document have evolved.

8 DR. NETON: Oh, definitely.

9 CHAIRMAN MELIUS: Yes.

10 DR. NETON: I think I can make as 

11 many changes as I can get, you know, 

12 reasonably within sort of half a day. And I 

13 can probably get this out to the full Board 

14 by Thursday, given that I don't have that 

15 much time. I'm not going to lock in a 

16 change, but I'll try to just do the simple 

17 ones.

18 And then I can present this to 

19 the Board, yes, it's not a problem. I was 

20 thinking about doing one other thing when I 

21 do my presentation, though. And I've got 

22 it, I've just displayed it here.

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1 I have a sense that there's a lot 

2 of people, some Board Members are not really 

3 familiar with what we really do with 

4 coworker modeling data and how it works.

5 And so I thought a brief presentation 

6 on an example from Savannah River might be 

7 appropriate. And what I put together here 

8 is a brief slide show that talks about a 

9 specific example from Report 81, or TIB-81 

10 that goes through how coworker models are 

11 constructed by year, go over how the data 

12 come out.

13 And then specifically talk about 

14 these graphs of how chronic models are fit 

15 through separate pieces. You know, and then 

16 end up showing how it overestimates at the 

17 very end and talk about what the GSBs and 

18 all that stuff sort of mean.

19 I don't know. Do you think that 

20 might be helpful as part of the process?

21 CHAIRMAN MELIUS: Yes, I do. Gen 

22 and Paul, do you --

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1 MEMBER ROESSLER: I think it's 

2 absolutely --

3 DR. NETON: I recall from the 

4 last meeting in Idaho that people were 

5 asking. I didn't have this type of 

6 information available at the time. And I 

7 think it would be very helpful to see here's 

8 a study of a coworker model.

9 MEMBER ZIEMER: I agree. I think 

10 that it's a good idea.

11 DR. NETON: I can do this piece 

12 as well as basically just go through the 

13 draft, which will be Rev 3 at that point. 

14 Okay. I can do that.

15 MEMBER ROESSLER: Good.

16 CHAIRMAN MELIUS: Okay. Thanks, 

17 Jim. I think the other, you want to do the 

18 other two items on our agenda? The first 

19 one is the ten year review. Well, ten year 

20 review on, we had talked about I think at 

21 the last Board conference call we were 

22 reviewing the ten year items. And it came 

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1 up that we, about DCAS was having 

2 difficulty, probably not surprisingly, in 

3 terms of addressing the comment about the 

4 need or the potential helpfulness of having 

5 input from other academic areas or even non6 academic areas in terms of applying the 

7 policies in terms of sufficient accuracy and 

8 some of the other, and SEC evaluation types 

9 of issues.

10 And I think you had, Stu, you had 

11 mentioned that it was causing -- we tried 

12 approaching it, were having difficulty sort 

13 of coming up with an approach that would be, 

14 you thought would be useful or at least in 

15 terms of how to frame the issues.

16 And I think I responded by saying 

17 well maybe we could talk about it as part of 

18 this Work Group meeting, at least I'm not 

19 sure we have a better idea, but at least we 

20 can try to address it if we can.

21 MR. HINNEFELD: Okay. Thanks, 

22 Dr. Melius. Yes, this is a, of course it's 

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1 problematic. We staffed -- the vision has 

2 been staffed. Largely, the technical people 

3 in the division are health physicists and we 

4 haven't really sought out a policy team so 

5 to speak and addressed these as an issue.

6 NIOSH always sort of interpreted 

7 its assignment on this program as a 

8 scientific assignment. And so that's kind 

9 of how we've approached it.

10 I do think that over the years, 

11 the continuing discussions with the Advisory 

12 Board and the Board's contractor, while not 

13 necessarily introducing other disciplines, 

14 has certainly introduced other points of 

15 view.

16 And I believe over the years we 

17 have had NIOSH also, and the Board and our 

18 contractor, have sort of converged on how 

19 things will be done. So I really question, 

20 and maybe some others of you who are not so 

21 close to it as I, maybe some others have 

22 some ideas about how this might be 

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1 accomplished and its value.

2 But I kind of question the value 

3 of at this point in the program, pursuing 

4 other opinions that, presumably would be 

5 somewhat less informed than those of us who 

6 have been working on the program.

7 We do, as the years have gone by, 

8 we have been, I believe, more accepting of 

9 input from the claimant and advocate 

10 community, and try to continue to take 

11 information they provide us seriously.

12 I'm not so sure that ten years 

13 ago we envisioned that that would be a large 

14 avenue, but I think they've provided a lot 

15 of useful information. And we have sort of 

16 incorporated that into our work process.

17 So I'm really no closer than I 

18 was at the Board conference call to having a 

19 good idea about how to go about something 

20 like this, but I kind of have the same 

21 opinions that I had then that I don't think 

22 the utility, I don't see the utility of 

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1 actually going out and pursuing other 

2 disciplines.

3 And I believe that the intent, 

4 which is to get a broadening of the thought 

5 process to the questions brought to our 

6 program, particularly the SEC questions, I 

7 think the intent of getting that broader 

8 perspective is largely satisfied by the 

9 relationship we've developed with the Board 

10 and the Board's contractor.

11 So I guess I'll stop there and 

12 see if anyone has anything else they want to 

13 say. Am I still on the phone?

14 MEMBER ROESSLER: Yes. Stu, 

15 what's the downside at this point if you 

16 don't get input from, as you call it, other 

17 disciplines?

18 MR. HINNEFELD: What is the 

19 downside?

20 MEMBER ROESSLER: Yes. I mean, 

21 if you just say well let's not do it, what 

22 would the implication be of not doing it? 

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1 What sort of criticisms could arise?

2 MR. HINNEFELD: Well, the 

3 criticism would be -- NIOSH said that, you 

4 know, you have this ten year review which 

5 was, you build it as this important review 

6 of your program, this fresh look. You have 

7 these recommendations, even some you might 

8 have considered priority recommendations and 

9 you have nothing to show for it. What 

10 happened to that?

11 Was this a real activity or not? 

12 You know, were you really serious about 

13 taking a serious look at yourself? And you 

14 know, that criticism could arise from 

15 wherever.

16 MEMBER ROESSLER: And I think 

17 that's a serious criticism.

18 MR. HINNEFELD: Yes, I agree. So 

19 I'm still open to suggestions then about 

20 what are the kinds of perspectives we seek 

21 and how do we pursue those.

22 And how do we, sort of, assure 

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1 ourselves that we will get, sort of -- you 

2 know, perspectives that kind of match the 

3 thought process that we've kind of been 

4 converging on, you know, NIOSH and the Board 

5 and their contractor on this process?

6 So you introduced a possibility 

7 of getting things that none of us would 

8 perceive as being helpful and may cause work 

9 to address in some fashion when those of us, 

10 you know, us I mean us and the Board and the 

11 Contractor would say gee, I don't see how 

12 that could possibly be helpful to pursue 

13 that.

14 On the other hand, I'm speaking 

15 here, I am so close to this that certainly 

16 my judgment on that matter could certainly 

17 be at question.

18 MEMBER ZIEMER: This is Ziemer. 

19 Let me raise a related question. Are there 

20 specific viewpoints or aspects that people 

21 feel NIOSH or the Board has been overtly 

22 rejecting?

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1 In other words, the outside, sort 

2 of new outside viewpoints that seem to be 

3 needed, are these viewpoints that someone 

4 has identified as being not considered or 

5 rejected or otherwise ignored?

6 I sort of feel the way Stu does, 

7 but I have my own bias. But I think the 

8 Board and the contractor and NIOSH itself 

9 have been pretty open to a lot of outside 

10 viewpoints. But I guess we hear from some 

11 that really are -- are there voices that 

12 aren't being heard or are being ignored?

13 CHAIRMAN MELIUS: This is Jim 

14 Melius. I don't think that it was meant as 

15 a criticism of, sort of, the process as 

16 much. I mean, there were other issues 

17 about, you know, input from the claimant or 

18 the claimant community so to speak that were 

19 sort of outreach issues and other issues 

20 that were included in the ten year review 

21 and are, I think, in the process of being 

22 addressed.

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1 I think the other thing is that 

2 we all are very close to the, you know, 

3 process and so forth. And as we continually 

4 find out, it's very hard to develop very 

5 general rules for this process because, you 

6 know, everything is case by case.

7 So most of our decisions are made 

8 by spending a lot of time reviewing a 

9 particular, you know, site or exposure at a 

10 site to what's available in terms of data 

11 and so forth.

12 And that often, you know, sort of 

13 precludes the development of general rules. 

14 Thorium is different at a different site so 

15 we can't just have a -- you know, we 

16 encounter thorium and therefore it's an SEC 

17 kind of rule or it's not an SEC or whatever.

18 So I think that's sort of where 

19 we are, our perspective on it, my 

20 recollection of the process was that for the 

21 ten year review was that that recommendation 

22 was more in terms of how the compensation 

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1 decision process was originally set up.

2 And would it be useful to have, 

3 you know, input from other disciplines that 

4 might be more familiar with other 

5 compensation processes or the ethics of this 

6 type of an effort. How do we, you know, 

7 evaluate fairness, how do we evaluate 

8 something like what is claimant friendly and 

9 things that have been incorporated into this 

10 program.

11 And would that possibly be 

12 helpful? I think Stu's right, it's a little 

13 hard to think specifically of what that 

14 would be. And particularly when we're so 

15 far down the line in terms of the number of 

16 years that we've, you know, this process has 

17 been set up and so forth.

18 So I think, you know, we all may 

19 have different views on what could have been 

20 done better or might have been different 

21 approaches that should have been considered, 

22 you know, however many years ago that 

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1 weren't.

2 But I think our obligation, Paul, 

3 back to yours, is not are we going to be 

4 criticized, not criticized, or is it really 

5 going to make a difference or not, but is 

6 there some way of exploring that trying to 

7 better understand how that might be helpful 

8 and is it feasible to incorporate that into 

9 the effort.

10 Now I believe that recommendation 

11 came from both John Howard and, well from a 

12 number of people but from John, from Randy 

13 Rabinowitz as part of her review of the SEC 

14 process.

15 And I mean, one way of pursuing 

16 it would be, you know, at our Work Group 

17 meeting because I think most of it was 

18 directed at the SEC Issues and invite, Randy 

19 could participate by phone or whatever to 

20 explain what she meant by that.

21 MEMBER ROESSLER: I'm not sure 

22 what she meant, but when you think about 

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1 this, the real difficulty of involving some 

2 more evaluation at this point is that it 

3 takes us, you think about an unbiased group, 

4 it seems that we have a real, they would 

5 need a huge knowledge base.

6 I don't know of any group, other 

7 than some that might be considered biased, 

8 that could get up to speed enough on what's 

9 being done and then actually on a timely 

10 basis be productive.

11 CHAIRMAN MELIUS: Yes, I don't 

12 have any specific examples to counter that. 

13 But I think at the same time, it was a, you 

14 know, recommendation that NIOSH and the 

15 commitment that NIOSH made to address, or at 

16 least explore.

17 And you know, I think it's 

18 something that certainly the Board could be 

19 involved in helping to explore it. And I 

20 think, you know, I think we take it like we 

21 do everything, a step at a time and see if 

22 it helps or if it doesn't help, if it's 

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1 feasible or not feasible.

2 MR. HINNEFELD: This is Stu. I 

3 think maybe inviting Randy to participate in 

4 a Work Group meeting might be an avenue to 

5 pursue. And we might be able to get, at 

6 least refresh my memory on where her thought 

7 was on this.

8 And then the other question is 

9 something like that consistent with the 

10 regulations that were published because 

11 theoretically the regulations could have 

12 been published in a different manner.

13 But that goes back, I think, 

14 farther than anybody wants to try to rewrite 

15 the program. And it's a matter of well, you 

16 know, can we, within the context of how the 

17 regulations were written, can we do 

18 something along those lines of other, you 

19 know, not writing this strictly as a 

20 scientific program.

21 Is there something we can do that 

22 perhaps this was, there were avenues that 

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1 maybe there should have been some policy or 

2 other kinds of thought process applied 

3 starting up as opposed to saying this is 

4 strictly a scientific program.

5 CHAIRMAN MELIUS: But there also 

6 may be some policy or procedure 

7 modifications that would be, you know, are 

8 not as dramatic as requiring regulation 

9 changes. I don't think we can --

10 MR. HINNEFELD: It would be 

11 preferable not to embark on regulations in 

12 any kind of timely fashion because who knows 

13 what happens then?

14 MEMBER ZIEMER: Well, Stu, the 

15 policy issues are still built into the 

16 program. I mean, the Board is just one 

17 voice of input to the Secretary's office.

18 So there's a whole other level of 

19 input that comes into play before any kind 

20 of decisions are made.

21 CHAIRMAN MELIUS: So if it's 

22 appropriate for everybody, I mean, let's see 

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1 where we are at the Board meeting next week 

2 in terms of follow up on the database issue.

3 I'm just thinking back to the 

4 coworker issue. When we were, you know, 

5 that was also a recommendation from the ten 

6 year review. And I think many of us, I'll 

7 speak for myself, I personally thought it 

8 was necessary to, we really deeded to 

9 address it.

10 But I think I and others had 

11 trepidations about doing so at this point in 

12 time and how we would go about that and how 

13 potentially disruptive it could be as a 

14 program.

15 And I think what we found out is 

16 that, you know, we are in the process of 

17 addressing it and I don't believe it will be 

18 as disruptive as we might have imagined, at 

19 least as I might imagine at the time when we 

20 started the process.

21 And maybe this will be the same. 

22 And you know, maybe it's something that's 

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1 just not feasible at this point. But least 

2 we can say we've evaluated and explored it, 

3 and provided some input to NIOSH on it.

4 MEMBER ZIEMER: Good point.

5 MS. LIN: Hi, this is Jenny.

6 CHAIRMAN MELIUS: Yes.

7 MS. LIN: If I can have a couple 

8 minutes. So you know, I've been away from 

9 the program for over a year. And I haven't 

10 touched anything on this ten years review 

11 program review since I returned.

12 But I'm a little curious, or I 

13 just need to do more work to really place 

14 that recommendation that we've been talking 

15 about today within the context because I 

16 think, you know, you tried to introduce that 

17 recommendation broadly over the entire 

18 program.

19 I'm not entirely sure that is, 

20 you know, that is really what the 

21 recommendation's about. And then on the 

22 other hand, I'm looking at the EEOICPA 

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1 statute where it specifically speaks to the 

2 type of advice from the Advisory Board.

3 And in the statutory provision, 

4 it talks about how the advice of the 

5 Advisory Board needs to be based on exposure 

6 assessment by radiation health professional.

7 So I think I just wanted to sort 

8 of center it back to the statutory 

9 obligation. And then, you know, examining 

10 that recommendation when the ten years 

11 program review within that context. Thank 

12 you.

13 CHAIRMAN MELIUS: So we'll plan 

14 out a Work Group meeting. We can talk about 

15 it more after RLA meeting next week.

16 The other item on our agenda is, 

17 I don't know where exactly where it stands. 

18 Again, I got caught by the password police 

19 or something and have not been on the CDC 

20 website in a week and a half or so.

21 But there's a Savannah River SRS 

22 coworker model that SC&A was reviewing that 

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1 the Savannah River Work Group sort of 

2 referred over to us. And I'm actually, at 

3 this point I was understood that it was 

4 close to -- the SC&A review was close to 

5 being finalized. I don't know if it's been 

6 transmitted.

7 MR. STIVER: Dr. Melius, this is 

8 John Stiver. It's almost ready to go to DOE 

9 for review as of today.

10 CHAIRMAN MELIUS: Okay.

11 MR. STIVER: So I anticipate, you 

12 know, depending on how long they take, maybe 

13 a couple of weeks. But certainly it's not

14 longer than that.

15 CHAIRMAN MELIUS: Okay.

16 DR. NETON: John, this is Jim 

17 Neton. Refresh my memory, is that TIB-81?

18 MR. STIVER: No. We're referring 

19 to Report 55, the trivalent actinides 

20 coworker model. That was the last of the 

21 nuclide specific models that we were looking 

22 at.

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1 DR. NETON: Right, got you. 

2 Sorry.

3 CHAIRMAN MELIUS: And it sort of 

4 got, well one, we got referred to the SEC 

5 Work Group because we were dealing with 

6 coworker issues. But the fact that we were 

7 dealing with coworker issues in a more 

8 general way than that site specific, took a 

9 little bit of time.

10 And I think SC&A was sort of 

11 waiting for us to make some progress before 

12 they sort of knew how to go about reviewing 

13 it to make that review more appropriate for 

14 the issues we were concerned about here.

15 So I just wanted to keep it on 

16 the NRQ here. And that would, again, be 

17 part of a Work Group meeting we might hold 

18 after the next Board meeting. But Ted, 

19 anything else?

20 MR. KATZ: No, no. I think we 

21 covered everything nicely.

22 CHAIRMAN MELIUS: Good. Boy, I 

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1 beat my fire drill. Either that or the 

2 building's burned down around me. I can't 

3 tell or I must have not heard the sirens, 

4 bells. But anyway, if no other business, 

5 thank everybody.

6 Thank you, Jim, a lot of work 

7 that you've done on this effort, and SC&A 

8 and everybody also. And I guess we'll see 

9 everybody in Los Angeles next week, or hear 

10 your voices.

11 (Whereupon, the above-entitled 

12 matter was concluded at 3:01 p.m.)

13

14

15

16

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