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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

 + + + + +

 SEC ISSUES WORK GROUP

 + + + + +

 FRIDAY

 FEBRUARY 5, 2010

 + + + + +

 The Work Group convened, via

teleconference, at 10:00 a.m. Eastern Standard

Time, James M. Melius, Chairman, presiding.

PRESENT:

 

JAMES M. MELIUS, Chairman

JOSIE BEACH, Member

MARK GRIFFON, Member

GENEVIEVE S. ROESSLER, Member

PAUL L. ZIEMER, Member
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ALSO PRESENT:

TED KATZ, Designated Federal Official

LYNN ANSPAUGH, SC&A

HANS BEHLING, SC&A

NICOLE BRIGGS, SC&A

PETE DARNELL, OCAS

SAM GLOVER, OCAS

STU HINNEFELD, OCAS

EMILY HOWELL, HHS

LARA HUGHES, OCAS

JENNY LIN, HHS

JOHN MAURO, SC&A

ROBERT McGOLERICK, HHS

DAN MCKEEL, Dow SEC Petitioner

JAMES NETON, OCAS

LaVon RUTHERFORD, OCAS

BILL THURBER, SC&A
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 TABLE OF CONTENTS

AGENDA ITEM PAGE

1. Update on Dow Madison SEC............... 9 

2. 250 Day Issue.......................... 70

 a. Review of Past Activities........ 70

 b. Ames site........................ 75

 c. Met Lab site..................... 77

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

2 (10:01 a.m.)

3 MR. KATZ: This is Ted Katz. I am 

4 the Designated Federal Official for the 

5 Advisory Board on Radiation and Worker Health 

6 and this is the SEC Working Group.

7 Beginning roll call with Board 

8 Members, note, please, if you have any 

9 conflict with either the Dow Madison site or 

10 Ames or Met Lab when you identify yourself for 

11 everyone related to the agencies, including 

12 the Board Members.

13 CHAIRMAN MELIUS: This is Jim 

14 Melius. I don't have any conflicts.

15 MEMBER ZIEMER: Paul Ziemer. No 

16 conflicts.

17 MEMBER BEACH: Josie Beach. No 

18 conflicts with either Dow, Ames, or Met Lab.

19 MR. KATZ: Okay. And then is Gen 

20 with us, Roessler?

21 (No audible response.)

22 MR. KATZ: Okay. Well, we'll call 
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1 for Gen and Mark again later because Mark is 

2 going to be a little late, too. I think Gen 

3 had some business away and was connecting from 

4 afar.

5 MEMBER ROESSLER: Hi, Ted. This 

6 is Gen.

7 MR. KATZ: Oh, hi. Great.

8 MEMBER ROESSLER: I am not away, 

9 actually, this week.

10 MR. KATZ: And no conflicts, Gen?

11 MEMBER ROESSLER: Pardon?

12 MR. KATZ: No conflicts?

13 MEMBER ROESSLER: No conflicts.

14 MR. KATZ: Great. Okay. And then 

15 let's go on to the OCAS-ORAU team.

16 MR. HINNEFELD: Stu Hinnefeld, the 

17 Interim Director of OCAS. I don't have 

18 conflicts with those three sites.

19 DR. GLOVER: This is Sam Glover. 

20 No conflicts.

21 MR. RUTHERFORD: LaVon Rutherford. 

22 No conflicts.
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1 DR. NETON: Jim Neton. No 

2 conflicts with those sites.

3 MR. DARNELL: Pete Darnell. No 

4 conflicts.

5 DR. HUGHES: Lara Hughes. No 

6 conflicts.

7 MR. KATZ: Okay. And then SC&A?

8 DR. MAURO: John Mauro, SC&A. No 

9 conflicts.

10 MR. THURBER: Bill Thurber, SC&A. 

11 No conflicts.

12 MR. ANSPAUGH: Lynn Anspaugh. No 

13 conflicts at these three sites.

14 DR. BEHLING: Hans Behling. No 

15 conflicts.

16 MS. BRIGGS: Nicole Briggs, SC&A. 

17 No conflicts.

18 MR. KATZ: All right. Then HHS or 

19 other government officials or contractors to 

20 the federal government?

21 MS. HOWELL: Emily Howell, HHS.

22 MS. LIN: Jenny Lin, HHS.
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1 MR. McGOLERICK: Robert 

2 McGolerick, HHS.

3 MR. KATZ: Okay. And then members 

4 of the public or staff of congressional 

5 offices who want to identify themselves?

6 DR. McKEEL: This is Dan McKeel. 

7 I am the Dow SEC petitioner.

8 MR. KATZ: Welcome, Dan.

9 DR. McKEEL: Hi.

10 MR. KATZ: Okay, then. Let me 

11 just remind everyone who is not speaking to 

12 put your phone on mute, *6 if you don't have a 

13 mute button, *6 to take it off of mute. And 

14 please don't put the call on hold. Hang up 

15 and dial back in if you have to leave. Thank 

16 you.

17 And, Jim, it's all yours.

18 CHAIRMAN MELIUS: Okay. Thank 

19 you, Ted. This is Jim Melius, Chair of the 

20 Working Group. As I said, Mark Griffon will 

21 be a little late. He should be joining us 

22 shortly. He was on his way to the office when 
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1 he called me a few minutes ago.

2 The agenda today, two major items, 

3 one, we will spend some time on Dow, the 

4 Madison site, to get an update on that; and 

5 then, secondly, we will start talking about 

6 the 250-day issue. I think, as you all know, 

7 John Mauro at my request has pulled together a 

8 lot of the information on the 250-day issue 

9 and has inundated us with documents, most of 

10 which, I think all of which, we have seen 

11 before, at least most of them, but I think it 

12 was helpful to see sort of the paper trail 

13 because this has been -- we have talked about 

14 a lot of different sites in regards to this 

15 issue in the 250-day issue. And it is, I 

16 think, helpful.

17 And then my understanding is that 

18 Sam Glover is now our main OCAS contact on 

19 this, the person who will be working through 

20 this Work Group. Some of that compilation was 

21 also to help Sam get caught up with all the 

22 past discussions that we have had on this Work 
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1 Group.

2 So I would like to start with Dow. 

3 And I have asked John to sort of update us on 

4 what has transpired and sort of what issues 

5 are outstanding with Dow Madison that we had 

6 discussed Dow at our last meeting of this Work 

7 Group, which was in July, so, really, what has 

8 gone on since that point in time.

9 John?

10 DR. MAURO: Yes. I'll pick it up

11 from July unless -- well, let me give you a 

12 really brief story. There were several 

13 stages. The original stage was the 1957-1960 

14 time frame, in which there was an SEC granted 

15 and there was the whole -- we went through the 

16 entire process related to that time period.

17 Then there was the -- and, 

18 basically, as you recall, Dow was doing 

19 thorium alloy work, where there was 

20 thorium-232 being handled and uranium at the 

21 same time during that time period. And there 

22 is a lot of literature. We put some reports 
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1 out on that. We had meetings on that.

2 Following that, there was another 

3 time period of interest, the residual period, 

4 where the concern was reconstructing exposures 

5 from the residual period. And for that 

6 period, it was a NIOSH position that they 

7 could reconstruct the doses to both uranium 

8 and thorium using a variety of methods. And 

9 that was the subject of considerable 

10 discussion.

11 Along the line, there was also a 

12 special report dealing with some 700 documents 

13 that were -- 700 pages of documents that arose 

14 during the process which were put into the 

15 record. SC&A was asked to review them and to 

16 see what relevance it might have.

17 And it turns out that, by and 

18 large, there was nothing of great substance 

19 there that really changed any of the dialogue 

20 we had, which brings us quickly to the meeting 

21 we had on July 24th, where, in effect, SC&A 

22 was requested to review the Dow Madison work 
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1 done by NIOSH, their reports, dealing with the 

2 post-1960 residual period and the methods in 

3 general that were being used, in light of 

4 TBD-6000.

5 And then SC&A put a report out 

6 dated August 2009. It was sent to everyone. 

7 It has been redacted and went through PA 

8 clearance. That document is available for 

9 public release and that is really the last 

10 report that I believe that SC&A put out on the 

11 subject.

12 By the way, Bill Thurber is the 

13 person that did 90 percent of the work on 

14 this. He is on the line and I am just going 

15 to very briefly go over. We had a number of 

16 findings related to the residual period and 

17 the methods that were being employed by NIOSH.

18 I would like to say that none of 

19 this has any -- doesn't really have any 

20 bearing on the 250-day issue, but it does have 

21 bearing on the surrogate data issue, something 

22 that maybe we should just draw your attention 
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1 to, even though today's discussion is zeroing 

2 in on 250-day.

3 There are certain surrogate data 

4 issues that have come up and the issues really 

5 have to do with, NIOSH in reconstructing doses 

6 for this facility is taking advantage of the 

7 great deal of data that is in TBD-6000 and is 

8 relying on that, the information that stands 

9 behind a lot of data that has been compiled 

10 related to airborne uranium at metal-handling 

11 facilities.

12 One of the more important comments 

13 we had, which I don't believe is an SEC issue, 

14 is that the method they have adopted was to 

15 use the geometric mean of the generic data for 

16 the particular categories of workers, as 

17 opposed to -- and that was based on a 

18 relatively limited amount of data for that 

19 category of worker, as opposed to using the 

20 95th percentile value.

21 So we have what I would call one 

22 of the more conventional commentaries that go 
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1 toward whether or not NIOSH was selecting from 

2 a data set at the right place in the 

3 distribution as their default approach for 

4 reconstructing internal exposures. And, by

5 the way, that would apply to the operations 

6 period, 57 to 60.

7 It was also a question of, during 

8 the residual period, reconstructing inhalation 

9 exposures. And, again, this is one of the 

10 more conventional comments that we have had on 

11 many occasions.

12 We felt that the resuspension 

13 factor that was selected was too low and they 

14 basically based the results on some estimate 

15 of residual radioactivity. And in order to 

16 get airborne activity, they apply a 

17 resuspension factor.

18 Their standard value of ten to the

19 minus six, I believe this is a generic issue 

20 that is being looked at by NIOSH. So this is 

21 not a concern that goes specifically to this 

22 site but is really a universal concern we have 
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1 regarding the use of a resuspension factor.

2 Another finding we had is that in 

3 doing the residual period and looking at the 

4 methods employed, one of our comments was that 

5 they -- again, this is a recurring theme.

6 There is a very good OTIB out 

7 called OTIB-0070, which lays out a methodology 

8 for reconstructing external exposures and 

9 internal exposures during a residual period, 

10 when you have limited data for the residual 

11 period. And OTIB-0070 has one particular 

12 protocol that we find extremely useful.

13 I think one of our comments was 

14 that that methodology should be applied. I 

15 think it wasn't entirely applied in this 

16 particular situation. I guess that really 

17 goes to the heart of the issues.

18 As I understand -- and, Bill, 

19 please fill in where I may have missed 

20 anything important -- the essence of our 

21 concerns with the methods used for 

22 reconstructing exposures during both the 
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1 operations period and the post-operations 

2 period go more toward how the data were 

3 applied from OTIB-0060 and the protocol they 

4 are using.

5 There is certainly some discussion 

6 that might be warranted regarding surrogate 

7 data issues. That is, they did draw upon 

8 TBD-6000 and to do some of the dose 

9 reconstructions. NIOSH did draw upon data 

10 from other facilities, the Bay City facility, 

11 to help with the thorium exposure.

12 So there was a considerable amount 

13 of drawing from other resources from other 

14 facilities to construct an overall approach to 

15 dose reconstruction during both the operations 

16 period and the residual period for thorium and 

17 uranium.

18 And when we reviewed this, I guess 

19 we felt that, as an overarching perspective, 

20 that the idea of using surrogate data -- and I 

21 know this is a subject that is before the 

22 Board -- in this particular application, when 
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1 you are dealing with a metal-handling 

2 facility, there is so much experience and data 

3 out there at a great level of resolution and 

4 granularity that you should be in a position 

5 to select from that vast amount of material 

6 and, if used appropriately, make assignments 

7 to a facility, such as Dow, to place a 

8 plausible upper bound. That has been SC&A's 

9 position related to that particular aspect of 

10 surrogate data.

11 So we do see it as scientifically 

12 plausible to reconstruct external/internal 

13 exposures for metal-handling facilities -- I 

14 want to make sure it's clear -- because of the 

15 amount of information that's out there. 

16 However, we do have concerns on a 

17 case-by-case basis when this is done, whether 

18 or not the most claimant-favorable and 

19 appropriate approach was used in applying that 

20 data.

21 That, I guess, gets up-to-date my 

22 reading of our material. And, Bill, is there 
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1 anything you would like to add regarding the 

2 work we have done?

3 MR. THURBER: No, I don't think 

4 so, John. As you say, some of the issues that 

5 we raised in our review of Appendix C of 

6 TBD-6000 are, in a sense, generic issues: the 

7 choice of the 95th percentile versus the 

8 geometric mean, that sort of thing, but I 

9 think you have covered it very nicely.

10 DR. MAURO: Okay. There's one 

11 last issue that I forgot to mention that I 

12 believe has been resolved. And that has to do 

13 with, during the residual period, one of --

14 the reconstruction of the internal dose of the 

15 inhalation of thorium-232 is based on 

16 measurements of thorium-232 collected during 

17 the operations period -- this is the pre-1960 

18 period -- of airborne thorium-232 levels. And 

19 then that was used as the starting point for 

20 inhalation exposures during the residual 

21 period.

22 Now, we find that fundamental 
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1 approach is, in fact, the approach recommended 

2 in OTIB-0070. We think it is a very good 

3 approach. The only commentary we had, which I 

4 think has been resolved, is that, in all 

5 likelihood, based on the operation that took 

6 place at the facility, the vast majority of 

7 the thorium alloy that was processed and used 

8 was for commercial purposes. And I think less 

9 than one percent of the material processed of 

10 thorium at Dow was for AWE purposes.

11 And then this also goes for the 

12 residual period, not only during operations, 

13 during -- when I say operations, during the 

14 period 1957 to 60, but also post-1960, the --

15 you know, right now I don't believe there's 

16 any information that says that there were any 

17 AWE activities going on, but there was 

18 certainly plenty of commercial activity going 

19 on.

20 So what happens is, if you use the 

21 airborne thorium data during the operations, 

22 1957 to 60 period, as our starting point for 
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1 the residual period and then from there 

2 project what the exposures are throughout the 

3 residual period, you are certainly going to be 

4 placing a very high estimate of the thorium 

5 exposures to the workers during the residual 

6 period by, I would say, more than one or two 

7 orders of magnitude.

8 However, we did have an extensive 

9 discussion of this matter. And I believe Jim 

10 Neton pointed out that the language in the 

11 rule was such that when you cannot make a 

12 distinction between the sources of exposure to 

13 a particular radionuclide, it is appropriate 

14 to simply apply the numbers, even though you 

15 realize that, in this case, the thorium is due 

16 to perhaps mostly by far either commercial 

17 operations -- it is appropriate within the 

18 framework of the regulations to just assume 

19 that all of that exposure to thorium was from 

20 AWE activities. And that certainly places an 

21 upper bound on what the exposures could be.

22 And so I think we did resolve that 
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1 issue during our last meeting and that that 

2 really, I think, closes the loop on our 

3 understanding of where things are right now on 

4 this site.

5 CHAIRMAN MELIUS: Okay. Thank 

6 you, John.

7 Any Board Members, Work Group 

8 members, have any questions of John or Bill on 

9 this?

10 MEMBER ZIEMER: This is Paul 

11 Ziemer. Are you going to mention the status 

12 of the investigation into the possible change 

13 in the time of the residual period and the 

14 outcome on that?

15 CHAIRMAN MELIUS: Yes. I was 

16 going to get next.

17 MEMBER ZIEMER: Okay. Thanks.

18 CHAIRMAN MELIUS: Yes. Thanks, 

19 Paul.

20 Others? Mark, are you on the 

21 phone yet?

22 (No audible response.)
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1 CHAIRMAN MELIUS: Okay. NIOSH, do 

2 you have any --

3 MEMBER GRIFFON: Jim, I am on, by 

4 the way. Sorry.

5 CHAIRMAN MELIUS: Oh, good. 

6 Welcome.

7 MEMBER GRIFFON: I had to find the 

8 mute button there.

9 CHAIRMAN MELIUS: Okay. Thanks. 

10 For our court reporter, that is Mark Griffon, 

11 our other Work Group Board Member.

12 NIOSH, do you have any comments 

13 you want to make in regard to --

14 MR. RUTHERFORD: Yes. Dr. Melius, 

15 this is LaVon Rutherford. You know, it kind 

16 of goes through each of the findings and talks 

17 about a response to them.

18 The first one concerning the use 

19 of the geometric mean during the operational 

20 period. First, I want to point out that that 

21 is during an SEC period so it is not an SEC 

22 issue, obviously, because it is already an 
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1 SEC.

2 What we did was actually arrange a 

3 value, TBD-6000. I also want to point out 

4 that that is the only spot I believe we use 

5 surrogate data. The actual residual period, 

6 as John mentioned; we used the actual thorium 

7 concentration from the Silverstein report, 

8 which was taken from Dow and we used that as 

9 our starting point.

10 The geometric mean we used 

11 actually had two points, the minimum value and 

12 the maximum value, to develop a geometric mean 

13 with a GSD of five.

14 So I think we do have a very 

15 claimant-favorable position, recognizing that 

16 there were only two periods of operations that 

17 are actually covered during the operational 

18 period for uranium.

19 If we assume the maximum value, I 

20 believe your actual PoCs are going to go down, 

21 which was the actual value of, I think, 4,300 

22 dpm per cubic meter. So I really don't think 
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1 that it would actually be claimant-favorable 

2 by using the maximum value.

3 And if you actually took the 

4 distribution along with the GSD and took the 

5 95th percentile, that really drives you to 

6 almost- implausible measures or intakes during 

7 that operational period.

8 So I think we are actually at a 

9 pretty good value with the current approach 

10 during the operational period for uranium. I 

11 will go through each of our responses for each 

12 one of these findings. And then we can go 

13 back to whichever ones we want to discuss.

14 The resuspension factor -- again, 

15 I think John mentioned that is like an 

16 overarching issue that I think the resolution 

17 to that is going to affect a number of 

18 different appendices and approaches. So I 

19 don't know that we really need to address it 

20 specifically on Dow.

21 The third finding that they had 

22 was NIOSH consider developing an exponential 
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1 decay function for uranium removal during the 

2 residual period. For some reason, we didn't 

3 do that. We did it for thorium. We used a 

4 constant exposure for uranium.

5 We agree to be consistent, that we 

6 should use an exponential decay function. 

7 However, I will say that that will lower the 

8 dose. And almost -- all but five of the 

9 existing claims that we have for Dow are 

10 complete right now. So those claims that are 

11 already complete would not be affected. But 

12 we will look into actually revising our 

13 uranium approach to be consistent with the 

14 thorium approach with an exponential decay.

15 The fourth finding, actually, 

16 which was not mentioned by John, I don't know 

17 that it -- there appears to be a data-entry 

18 error in Table C-2 for the residual period.

19 Again, we agree with Bill on that 

20 one, with SC&A, that we did enter some data 

21 incorrectly. It is actually just -- we 

22 transposed the data incorrectly. But, again, 
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1 that will actually lower the dose when we fix 

2 that. So we don't intend to go back to redo 

3 any dose constructions and actually lower dose 

4 on those.

5 I discussed the surrogate data 

6 issue. Again, I believe the only use of 

7 surrogate data is during an SEC period and 

8 those would be for the non-presumptive 

9 cancers.

10 During the residual period, I 

11 guess you could argue that the residual period 

12 used it because the uranium starting point is 

13 actually based on surrogate data. So that 

14 would be the only argument I guess you could 

15 use to say that it is surrogate data during 

16 that period, during the residual period.

17 That is pretty much our responses.

18 DR. MAURO: This is John. Just a 

19 couple of quick ones, you know, just reacting 

20 and listening. When you had mentioned the 

21 uranium, using the geometric means for the two 

22 values and that if you used a max value, it 
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1 would be even lower than using the geometric 

2 mean, I guess I am not following that.

3 That is, if you have got two 

4 values, data points, let's say, for air 

5 concentration of uranium for the purpose of --

6 now, if you took the -- my understanding is, 

7 if you've got two values, the geometric mean 

8 is the product of those two values and the 

9 square root, square root of the product, two 

10 values, that would be your geometric mean. 

11 And then on that you used a GSD of a factor of 

12 five.

13 And our comment was, in a 

14 situation like that, when you have limited 

15 data and you are trying to place a plausible 

16 upper bound on all of those -- now, this is 

17 during the operations period for uranium and I 

18 recognize it only applied to people who are 

19 not covered under the type of cancer.

20 How would using the maximum value 

21 be less conservative than using a fixed 95th 

22 percentile value that you might get out of 
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1 that distribution? I am not following that. 

2 You lost me.

3 MR. RUTHERFORD: Well, I'm saying 

4 we could use that. We could go ahead and use 

5 that maximum value. I think there is concern 

6 from our internal dosimetrist, Dave Allen, 

7 that it made lower PoCs.

8 And Jim Neton, maybe, will pipe in 

9 on that. I'm not sure.

10 DR. NETON: This is similar to a 

11 discussion we had, I think, on another site, 

12 where if you put a GSD of five about the 

13 geometric mean, you end up with a distribution 

14 that we are applying. And that is going to 

15 generate a distribution of values of which 

16 you're going to have some very high values up 

17 at the upper tail --

18 DR. MAURO: I got it. I got it. 

19 I see. So by getting the geometric mean by 

20 issuing those two values, okay, you've got a 

21 number and then, independent of that, you 

22 apply this geometric standard deviation of 
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1 five --

2 DR. NETON: Exactly.

3 DR. MAURO: -- where that five 

4 puts you way over the upper end of the value 

5 you got when you got your geometric mean.

6 DR. NETON: Exactly.

7 DR. MAURO: I see. Yes. We 

8 haven't checked that, but intuitively, I --

9 MR. THURBER: John?

10 DR. MAURO: Yes?

11 MR. THURBER: This is Bill.

12 DR. MAURO: Yes?

13 MR. THURBER: We had this 

14 discussion here a few weeks ago and we did 

15 some calculations and in some cases, it 

16 showed, as you will recall, that using the 

17 geometric mean and a GSD of five resulted in a 

18 higher Probability of Causation. And in some 

19 cases, using the deterministic 95th percentile 

20 resulted in a higher Probability of Causation. 

21 So I don't think one can say --

22 DR. NETON: Bill, we're not 
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1 talking about using the 95th percentile as a 

2 distribution.

3 MR. THURBER: Yes.

4 DR. NETON: We're talking about 

5 using the maximum value of the range that was 

6 observed. That is very different.

7 MR. THURBER: Yes. Yes.

8 DR. NETON: See, we're saying 

9 you've got a range of values. You can either 

10 use the highest value you found of all the 

11 values or you can use the geometric mean of 

12 the values, of the two values that were 

13 observed, the ranges that were observed with a 

14 GSD of five.

15 MR. THURBER: I understand what 

16 you're saying, but I think our comment, our 

17 finding at the time, back in last August or 

18 whenever, was that we felt the 95th 

19 percentile, which you can determine from those 

20 statistics, was a more appropriate measure. 

21 We didn't say, use the maximum value.

22 DR. NETON: And that is what LaVon 
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1 had talked about. If you used the 95th 

2 percentile, you end up with some, I think, 

3 values that come out extremely high, you know, 

4 something around 25,000 dpm per cubic meter 

5 for, I think it was at that time, a 

6 rod-straightening operation or something. 

7 I think the arguments are on the 

8 table. Maybe we don't need to belabor it on 

9 this call because, again, as LaVon indicated, 

10 this is already an SEC.

11 These values are being applied to 

12 non-presumptive cancers. And we are certainly 

13 willing to discuss that as an issue, maybe 

14 aside from the SEC evaluations.

15 DR. MAURO: I think the issue is 

16 very clear. What is good about this is that 

17 there are different strategies that one could 

18 apply when dealing with this particular 

19 circumstance.

20 Now, if you've got two 

21 measurements, you are confronted with the 

22 situation, you know, what do you do with two 
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1 measurements? You know --

2 MR. RUTHERFORD: John, I want to 

3 point out there are more than two 

4 measurements. Yes. There are two 

5 measurements that were used to define the 

6 boundaries of the max and the min. There were 

7 a lot more measurements in between those.

8 DR. MAURO: Okay. Okay. Well, 

9 you know how I am thinking about this -- and I 

10 see the mechanics of it now, then. It all 

11 rings true in terms of understanding why it 

12 comes out the way it comes out.

13 It's this geometric standard 

14 deviation of five. That creates the 

15 circumstance by applying it to the geometric 

16 mean you got from these two values.

17 If you were to take all of the 

18 values that you do have, which it sounds like 

19 you do have more than two then, and you were 

20 to make a ranking from high to low and using 

21 -- forget about deriving the 95th percentile 

22 based on the geometric standard deviation of 
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1 five that you get the way -- you know, sort of 

2 like an artificial spread, but use the real 

3 spread.

4 In other words, let's get the real 

5 data. Let's say you have 20, 30 numbers. I'm 

6 not sure how many numbers you actually have 

7 for that category of worker. And you rank 

8 order them. Don't even try to -- well, you 

9 can come up with an upper-bound value.

10 Let's say you simply just rank 

11 ordered them and, from that, you pull off the 

12 non-parametric 95th percentile. I would be 

13 very interested in knowing where that fits in 

14 because if you do have the real data, then you 

15 are looking at a situation where the geometric 

16 standard deviation that really exists may not 

17 bear any resemblance to five. It may be 

18 something much less.

19 And then, all of a sudden, I guess 

20 where I am headed with this is, the scientific 

21 basis upon which you are making your 

22 conclusion is actually drawn from the full 
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1 distribution of data that you do have.

2 And if you are pulling off the 

3 high end of that number and applying that as 

4 your way of reconstructing in this case 

5 uranium exposures for the time period of 

6 interest, that would be much more in keeping 

7 with the philosophies that we have been 

8 talking about.

9 Taking the min and the max and 

10 then you may end up -- I mean, I don't know 

11 where you will come out, but taking the min 

12 and the max and multiplying two, taking the 

13 square root, and getting your geometric mean, 

14 and then applying this factor-of-five GSD and 

15 then using the full distribution, that brings 

16 you to a place where, when you use that as 

17 input into IREP, okay, you will come out with 

18 a Probability of Causation.

19 I would be very interested in 

20 knowing if you did it a different way, one 

21 that I feel is more scientifically grounded, 

22 take all your data that you have for that 
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1 category, pick off the upper 95th percentile, 

2 wherever that happens to fall. And I like the 

3 rank order approach, as opposed to the 

4 curve-fitting approach, for a variety of 

5 reasons. And take it off the 95th percentile 

6 and then running with it and seeing where that 

7 brings you in terms of the Probability of 

8 Causation.

9 It may end up bringing you lower, 

10 you know, than the approach you are using or 

11 higher. I just don't know. But it seems to

12 be a scientifically more well-grounded 

13 approach than this application of the GSD of 

14 five, as adopted. I think it is at least 

15 worth looking into.

16 MR. RUTHERFORD: I will let Dan 

17 respond to that.

18 DR. MAURO: But, I mean, there are 

19 going to be lots of -- I am not going to say 

20 lots. There are a number of cancers that you 

21 do have to reconstruct doses for.

22 MR. RUTHERFORD: Well, I agree. I 
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1 understand the approach you suggested, and we 

2 are certainly willing to look into that.

3 DR. MAURO: Thanks.

4 CHAIRMAN MELIUS: Why don't we 

5 leave it at that? We are trying to focus on 

6 the SEC review here.

7 Anybody else have questions or 

8 comments, Board Members?

9 (No audible response.)

10 CHAIRMAN MELIUS: Okay. As Dr. 

11 Ziemer mentioned earlier --

12 MEMBER ZIEMER: I'm sorry. What 

13 did you say, Jim?

14 CHAIRMAN MELIUS: I was actually 

15 saying as you mentioned. I was actually 

16 picking up on your point.

17 MEMBER ZIEMER: Oh, right. Okay.

18 CHAIRMAN MELIUS: I was giving you 

19 credit for raising it.

20 One of the reasons that there has 

21 been delay in addressing the SEC issues here 

22 -- I think they are to some extent 
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1 interrelated -- is there have been concerns 

2 about some information provided regarding what 

3 should be the covered period for this 

4 particular facility.

5 And then, I guess related to that, 

6 the petitioner, Dr. McKeel, has had long 

7 delays in getting access to some of the 

8 information that the petitioners believe and 

9 so I would agree with him are relevant to them 

10 having adequate information to represent the 

11 favor of their petition.

12 Maybe a way to start on that would 

13 be, Dr. McKeel, you are still on the line?

14 DR. McKEEL: Yes.

15 CHAIRMAN MELIUS: If you would 

16 like to sort of update us on where you are? 

17 And then I believe that you had also asked Ted 

18 Katz to share some of the more recent 

19 correspondence with the Department of Labor 

20 with the Work Group members, which Ted did, I 

21 believe, earlier this week.

22 Dr. McKeel?
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1 DR. McKEEL: Yes. So where that 

2 stands is I first asked Ted Katz, could I 

3 retrieve [identifying information redacted]

4 information that she presented to the Board 

5 and then as information packets? I wasn't 

6 exactly sure she had given to the Board, but 

7 my question was, could I obtain that 

8 information directly from the Board under 

9 FACA?

10 And there was a seven-month gap 

11 where NIOSH was formulating policies for 

12 sharing information that was given directly to 

13 the Board.

14 And the bottom line was the answer 

15 came back that no, the Board couldn't share 

16 that information. So I've submitted a FOIA 

17 request for all of [identifying information 

18 redacted] information to Department of Labor.

19 And they indicate that, actually, 

20 they should have a response soon, maybe 

21 including today or within a few days, to not 

22 necessarily deliver that information but just, 
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1 could they provide it and would they provide 

2 it.

3 And, actually, the Department of 

4 Labor was very cooperative. And Rachel Leiton 

5 sent me copies of both her responses to 

6 [identifying information redacted] in which 

7 Department of Labor gave their reasoning why 

8 they do not think that the information she 

9 presented was sufficient documentation to 

10 enable them to change the covered period.

11 I have a response to the last 

12 letter, which I have not yet had a chance to 

13 deliver to the Department of Labor, but the 

14 absence of [identifying information redacted]

15 last presentation to the Board on this subject 

16 and the thrust, as I understand it, of the 

17 material she sent to the Department of Labor 

18 were that there was a particular temper of 

19 HK-31 magnesium-thorium alloy that was only 

20 made at Dow Madison and that that was the 

21 specific temper that was used in the nuclear 

22 weapons that led to the classification of Dow 
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1 as an AWE site based on thorium work.

2 So I don't know. That particular 

3 point was not well addressed, in my opinion, 

4 in the final letter. And that was the essence 

5 of what new information [identifying 

6 information redacted] claimed she had.

7 My request at this point is that 

8 -- so the Department of Labor has gotten that 

9 material. I believe [identifying information 

10 redacted] sent similar packets to NIOSH and to 

11 the Department of Energy. And I don't know 

12 whether she sent it or not to SC&A and/or the 

13 Board.

14 But, in any case, it should be 

15 available from NIOSH. And I certainly think 

16 that that information -- I do not have a copy 

17 of it yet. 

18 So I would like to propose, ask, 

19 and request that the Board task SC&A to review 

20 all of the material that [identifying 

21 information redacted] has presented because it 

22 doesn't go just to changing the covered 
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1 period.

2 It goes to what some of the 

3 production processes were. It goes to the 

4 specific issue, which was new to me, that 

5 there was a particular -- I think she cited 

6 five or six different tempers of the way that 

7 the HK-31 alloys were cured.

8 And, you know, one of them turned 

9 out to be ideal for nuclear weapons. And she 

10 says that that was made at Dow Madison's 

11 plant.

12 So I think there needs to be an 

13 independent assessment of that apart from 

14 Department of Labor, which, you know, is one 

15 voice and certainly is the primary decider. I 

16 think all of that information is highly 

17 relevant to the SEC. So I would ask that that 

18 be done.

19 I think from everything I 

20 understand, the Department of Labor will 

21 probably send me the [identifying information 

22 redacted] information rather quickly. I don't 
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1 know what the time frame would be. So that is 

2 where that issue stands.

3 I do have a few comments, just a 

4 couple, on the discussion we had about the 

5 findings on Appendix C. I don't know if it's 

6 appropriate to comment on those.

7 CHAIRMAN MELIUS: Why don't you 

8 wait a second?

9 DR. McKEEL: Okay.

10 CHAIRMAN MELIUS: Let's pick up on 

11 what you just said --

12 DR. McKEEL: Yes.

13 CHAIRMAN MELIUS: -- so we don't 

14 lose the train of thought. But I will come 

15 back and give you an opportunity for the other 

16 comments.

17 DR. McKEEL: Yes.

18 CHAIRMAN MELIUS: This is a hard 

19 question to grasp because we don't know what 

20 was submitted and where it went and so forth. 

21 Does NIOSH have any response?

22 Does NIOSH believe that the 
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1 information that [identifying information 

2 redacted] sent to Department of Labor that 

3 NIOSH also -- does NIOSH also have that 

4 information or believe they have that 

5 information?

6 MR. RUTHERFORD: This is LaVon 

7 Rutherford. I do believe we have that 

8 information that [identifying information 

9 redacted] sent to the Department of Labor.

10 CHAIRMAN MELIUS: And is that 

11 information available to SC&A or has it been 

12 made available to the --

13 MR. RUTHERFORD: All the 

14 information [identifying information redacted]

15 supplied to us is on the Site Research 

16 Database and available to SC&A. Now, from a 

17 dose-reconstruction perspective, the 

18 information is not really affecting anything 

19 associated with dose reconstruction.

20 CHAIRMAN MELIUS: I guess that is 

21 NIOSH's conclusion about it based on their 

22 review. That is not something that the Board 
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1 has dealt with nor SC&A, if I understand it.

2 MEMBER ZIEMER: Dr. Melius?

3 CHAIRMAN MELIUS: Yes?

4 MEMBER ZIEMER: Paul Ziemer here. 

5 I understand Dr. McKeel's request. I would 

6 simply make a point, which I make frequently 

7 in many such situations, not SEC situations 

8 per se but in general, and that is it seems to 

9 me that the ball is in NIOSH's court to make 

10 an initial evaluation.

11 I always have to point out I don't 

12 like SC&A doing federal work. I want them to 

13 do Board work and I think it is premature for 

14 us to look at [identifying information 

15 redacted] data, which she submitted to DOL.

16 I don't believe the Board per se 

17 -- she has not submitted this to us, as far 

18 as I am aware. It seems to me that in the 

19 evaluation, it is NIOSH's job to evaluate this 

20 kind of thing and make recommendations to DOE 

21 or DOL if they believe the period should be 

22 changed.
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1 I agree, at some point if it 

2 becomes obvious that there is an issue on how 

3 that evaluation was done or whether the 

4 correct evaluation was done, but until we see, 

5 for example, a product, it seems to me at this 

6 point, it is inappropriate to task.

7 We haven't even seen it. So I 

8 think we would be tasking sort of in the dark 

9 at this point.

10 MR. HINNEFELD: This is Stu 

11 Hinnefeld from NIOSH. I just wanted to offer 

12 one thing. I wasn't quite sure what Paul felt 

13 like our action would be there. Did you want 

14 us to look at this and make some kind of 

15 recommendation?

16 MEMBER ZIEMER: Well, I believe I 

17 heard Dr. McKeel say that he felt we should 

18 task SC&A to review the [identifying 

19 information redacted] data and evaluate, and 

20 Dr. McKeel can clarify. I think he was 

21 interested both in the processes which might 

22 certainly be of interest from a 
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1 dose-reconstruction point of view, but the 

2 heart of the matter is the issue of changing 

3 the covered period, which, in essence, is a 

4 DOL/DOE task and to some extent is outside of 

5 our purview to start with. So I get a little 

6 antsy about getting into that ballpark with 

7 the tasking of reviewing material that we have 

8 not even seen.

9 MR. HINNEFELD: Yes. Our role in 

10 things like extension of classes or the length 

11 of classes or things like that has always been 

12 that we would provide any information we found 

13 that we thought was relevant to the Department 

14 of Energy or Labor, whichever was applicable 

15 or both. But we don't particularly give them 

16 advice on their interpretation of that 

17 information and how to set the Class.

18 So that responsibility is assigned 

19 to them. And we have not really put ourselves 

20 in a position of sort of evaluating that 

21 information for them and advising them.

22 So if the desire is that we 
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1 provide some sort of analysis to explain 

2 either our conclusion that there is no effect 

3 on dose reconstruction or that here is the 

4 information and this is our position with 

5 respect to dose reconstruction, we can do 

6 that.

7 But with respect to the duration 

8 of the covered period, I would not think that 

9 we -- I mean, I can speak with others in the 

10 Institute after we get off the meeting, but I 

11 would not think we would start to take on the 

12 role of giving advice to the other agencies on 

13 fulfilling what are their responsibilities.

14 CHAIRMAN MELIUS: Yes. Jim 

15 Melius. A couple of comments on that. I 

16 agree that the covered period and processes; 

17 that is not our purview. I guess what was 

18 said was about the submission of information 

19 as you find it during your research would be 

20 -- you know, it's appropriate if you find 

21 something that brings into question the 

22 covered period or something else important 
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1 about the site that DOL should know, then you 

2 would bring it to attention.

3 I guess the only situation where I 

4 think that something else arises, you know, do 

5 you have information that, in combination with 

6 what [identifying information redacted]

7 provided, would be of pertinence to the DOL's 

8 review? But even that I think is not 

9 something that certainly the Board is directly 

10 involved in.

11 I guess my question was more from 

12 the point of view, was there something in that 

13 information that would be relevant to what we 

14 were reviewing now, which we have already 

15 granted the SEC for the current cover. There 

16 may be information in there that would be 

17 relevant that NIOSH would use in the dose 

18 reconstruction for the non-covered cancers.

19 It may or may not be. I don't 

20 know. You know, I have not looked at that 

21 information so I can't say. I mean, but that, 

22 again, is not something currently -- our Work 
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1 Group is currently looking at.

2 And I guess the issue that we are 

3 looking at right now is the question of, 

4 should the SEC be extended to include parts or 

5 all of the residual period?

6 I guess the question would be, it 

7 would be any of the information there in that 

8 -- that has been submitted by [identifying 

9 information redacted] and NIOSH has. Is that 

10 relevant to the residual time period?

11 DR. McKEEL: Dan McKeel.

12 CHAIRMAN MELIUS: Yes?

13 DR. McKEEL: Can I make a comment 

14 about that specifically? I mean, my 

15 understanding is that the information involves 

16 new information about the AEC contract that 

17 governs the thorium work and that that, what 

18 she is saying is that she has presented 

19 information that indicates the production 

20 period for thorium extended beyond 1960. So 

21 that would be into the residual period and I 

22 think that makes it directly relevant.
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1 And also I would point out that 

2 [identifying information redacted] did make 

3 her presentation directly to the Board and had 

4 handouts which had summaries of that 

5 information. And it is in the Board 

6 transcript.

7 So this is not something that was 

8 only given to NIOSH or only given to DOL or 

9 DOE. It was also presented directly to the 

10 Board.

11 Now, whether she transmitted her 

12 information packet to the Board I don't know, 

13 but, for practical purposes, her information 

14 packet, as Stuart just said, is on the SRDB. 

15 So it is readily available to you all and it 

16 will soon be to me.

17 As a practical matter, as soon as 

18 I get it, I will forward it to the Board. So 

19 that is just something to consider.

20 COURT REPORTER: This is the court 

21 reporter. May I ask who you are?

22 DR. McKEEL: I'm Dan McKeel.
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1 COURT REPORTER: Dan McKeel? 

2 Okay. I just wanted to make sure.

3 DR. McKEEL: Yes. Sorry.

4 COURT REPORTER: Okay. Thank you.

5 CHAIRMAN MELIUS: Anybody else 

6 have comments from the Board Members?

7 (No audible response.)

8 CHAIRMAN MELIUS: Dr. McKeel, you 

9 had some other comments also?

10 DR. McKEEL: Yes, I did. I will 

11 make them very briefly. I believe that the 

12 surrogate- data issue is a big issue and would 

13 take exception to the discussion this morning. 

14 There are several places where surrogate data 

15 was used. And the SC&A review of Appendix C 

16 cites these as well.

17 For example, film badge data from 

18 the Bay City, Michigan Dow plant was used. 

19 And the comment was made as far as justifying 

20 this as appropriate use of surrogate data was 

21 that the Bay City, Michigan facility was 

22 similar -- that's a quote -- to Dow Madison 
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1 without any other justification at all. So I 

2 don't think that has been proven how similar 

3 it was. So that is just a statement.

4 The other surrogate data that was 

5 used was data from Conalco, which eventually 

6 wound up owning the Dow, former Dow facility 

7 but air sampling data from the 1980s was 

8 applied back to characterize air 

9 concentrations during the operational period 

10 in the 1950s. And I would question that as 

11 being entirely appropriate.

12 The other thing is that I have 

13 raised repeatedly, and it really has not been 

14 settled, and that is that the Silverstein 

15 report from 1956 and 7 -- although Dr. 

16 Silverstein on paper was the radiation safety 

17 officer for Dow Madison plant, it is clear 

18 that he was based in Michigan. He did not 

19 live or stay, certainly, at the Dow Madison 

20 plant.

21 In fact, none of the workers that 

22 are now alive and have given testimony are 
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1 aware of Silverstein's work. That doesn't 

2 mean that it doesn't exist, but they do point 

3 out that Dr. Silverstein in one of his reports 

4 provides a diagram of what is supposed to be 

5 the Dow Madison pot room, where they did the 

6 castings for thorium alloys.

7 And it simply is not a picture of 

8 any configuration of that pot room that any of 

9 the workers alive now are aware ever existed. 

10 There were seven pots shown in the schematic; 

11 whereas, there were ten actually at Dow.

12 So they believe that that is a 

13 sketch of another facility, maybe the pot room 

14 at Bay City, for example. But it is not the 

15 pot room at Dow Madison.

16 So I have contested, and I don't 

17 believe it has really been settled. There is 

18 a very loose use of the word Dow, which 

19 encompasses many of the sites. Dow had a 

20 single thorium license to cover their 

21 facilities in Michigan, in California, the Dow 

22 Madison plant. And I think the only relevant 
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1 data that is not surrogate data is data 

2 directly from Dow itself.

3 So, for example, when you talk 

4 about Bay City being similar to Dow Madison, 

5 one thing that wasn't similar was that they 

6 had film badge data from the Bay City, 

7 Michigan facility. If it is so similar to Dow 

8 Madison, why wouldn't they have any film badge 

9 data for Dow Madison? And there is zero film 

10 badge data or bioassay data for Dow Madison.

11 So if Dr. Silverstein were the 

12 radiation safety officer at both facilities, 

13 it seems inconceivable that he would institute 

14 a film badge program at one and then at 

15 another place, where it is stated there were 

16 identical production facilities, he wouldn't 

17 institute a film badge program at Dow Madison.

18 We don't have any indication that 

19 there was a film badge program at Dow Madison. 

20 So I just think that whole issue is a huge 

21 issue.

22 The Surrogate Data Work Group has 
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1 not been involved in that decision. And 

2 clearly in my mind, the justification for 

3 using that surrogate data at Dow Madison 

4 certainly doesn't comply with the criteria, 

5 either the draft Board criteria or the OCAS 

6 IG-004 surrogate data criteria. So I just 

7 make a plea that that be examined.

8 The final comment that I wanted to 

9 make was about using exponential decay for the 

10 residual period for both uranium and thorium. 

11 Now, I can understand it for uranium, where, 

12 as far as we know, once the extrusion work 

13 that was done and the straightening operations 

14 were done during 57 and 60, that there was no 

15 more introduction of new uranium at the Dow 

16 facility.

17 And so you could say that there 

18 was a level present at the end of the 

19 production period and then it decayed 

20 exponentially throughout the residual period. 

21 That's okay, although uranium-238 has a very 

22 long half-life.
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1 But, anyway, let's say that that 

2 were true. For thorium, I don't think that is 

3 the case at all. As was acknowledged by John 

4 Mauro, the language of the Act says that if 

5 you can't distinguish between AEC and 

6 commercial radioactive materials, then all of 

7 it has to be considered as AEC material. And 

8 I think that is very clear.

9 So in the case of Dow Madison, 

10 there was active production of 

11 magnesium-thorium alloys HK-31, HM-21 that 

12 extended from 1961 through the 60s, the 70s. 

13 Conalco made it. And, actually, it extended 

14 up until the time that Spectrolite bought the 

15 facility and the workers have testified that 

16 there were thorium production runs into the 

17 early 1990s at least.

18 So what I believe should be a more 

19 appropriate model is that you had multiple 

20 introductions of thorium source term material. 

21 And so a single exponential decay curve 

22 wouldn't describe that situation at all. 
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1 Rather, what you have is multiple 

2 introductions of thorium.

3 We know that there was thorium all 

4 over the facility in the 2006-2007 period, 

5 when Pangea was cleaning it up, actually 

6 starting in 2004 but completing it late in 

7 2007, there was thorium in every building in 

8 the Dow building complex.

9 So, you know, if you thought of 

10 multiple exponential decay curves, then there 

11 was always a peak and a beginning of the down 

12 slope. And then another curve would be 

13 superimposed on that so that what you would 

14 actually have is an average value during the 

15 residual period that would more approximate 

16 close to the peak values, rather than a decay 

17 curve where at the end of that decay curve, 

18 you know, it was sharply curtailed. So I just 

19 question that model as being the appropriate 

20 one.

21 The final, other comment I will 

22 say is that, although everybody seems to 
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1 accept that TBD-6000 is an excellent model for 

2 what happened at Dow Madison. I will comment 

3 that TBD-6000 has zero information about 

4 thorium in it. That's one.

5 And, number two, when you talk 

6 about metal, heavy metal operations on uranium 

7 and thorium, there is a very highly pertinent 

8 issue that basically has been glossed through.

9 And that is that at many DOE sites 

10 -- and I have seen pictures of them. I can 

11 produce pictures of them. Many of the 

12 extrusion presses for uranium were covered by 

13 vacuum hoods. And they were constantly 

14 operating and sucking the dust away from those 

15 machines as that uranium, which was often --

16 you know, it was a very dusty operation. It 

17 would often crumble. Pieces would fall out. 

18 Men would have to dig those up.

19 But, anyway, those vacuum hoods 

20 were expressly designed to carry that dust 

21 away. And it is clear at the Dow Madison 

22 facility, there were absolutely no hoods at 
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1 all on any of the extrusion presses, of which 

2 there were I think nine at one period.

3 In my reading of TBD-6000, the 

4 distinction between an extrusion press with a 

5 hood and without a hood and showing the 

6 comparative doses of uranium or thorium dust 

7 inhalation just aren't present in that 

8 document. So I don't think that is an 

9 entirely adequate document for the uranium 

10 intakes that were experienced at Dow Madison. 

11 Okay. So thank you very much.

12 CHAIRMAN MELIUS: Thank you, Dr. 

13 McKeel.

14 Any comments from Board Members or 

15 NIOSH?

16 (No audible response.)

17 CHAIRMAN MELIUS: No? My only 

18 comment -- and maybe Stu or someone can 

19 clarify -- is your comment on the multiple 

20 exponential decay. My understanding, I 

21 thought, was that during the residual period 

22 only, the sort of the covered processes were 
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1 what were taken into account.

2 It's different during the covered 

3 period, as opposed to the residual period. Is 

4 that correct?

5 MR. HINNEFELD: Yes, that's 

6 correct, that during the residual period, that 

7 we were required to reconstruct the material 

8 that is residual from the covered operation.

9 CHAIRMAN MELIUS: Yes.

10 MR. HINNEFELD: And so those ended 

11 in -- I forget the date now -- 1960 or 

12 whatever the determination was at the end of 

13 the covered period that the Department of 

14 Labor has made. Then we would be 

15 reconstructing, during the residual period, 

16 contamination that was left over from those 

17 operations that ended in whatever it is. I 

18 forget the date.

19 COURT REPORTER: This is the Court 

20 Reporter. Please identify yourself.

21 MR. HINNEFELD: I'm sorry. I'm 

22 sorry. Stu Hinnefeld.
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1 COURT REPORTER: Okay. Thank you.

2 CHAIRMAN MELIUS: Even though that 

3 may not be logical in terms of the exposure 

4 people experienced, it is the way the 

5 legislation is set up.

6 DR. McKEEL: I understand that.

7 CHAIRMAN MELIUS: Yes. Thank you. 

8 Yes. No. Thanks. Thank you.

9 What I would propose we do is -- I 

10 think we all need, at least I need, to re-look 

11 at the letter from the Department of Labor, I 

12 think in the context of what Dr. McKeel, some 

13 of the issues he raised and some of the other 

14 questions.

15 But I think we would, I think, try 

16 to at our next meeting of this Work Group pull 

17 everything together and try to -- I think we 

18 need to reach a conclusion on this particular 

19 SEC petition as applied to the residual period 

20 as best we can based on where things stand at 

21 that point in time, and recognizing that there 

22 are unresolved issues that may be continued 
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1 concerns about the covered period.

2 So maybe at the end of the call, 

3 after we have talked about the 250-day issues, 

4 we will sort of figure out a schedule and put 

5 it together. And I would plan on doing that 

6 between now and obviously not the next Board 

7 meeting but the following Board meeting.

8 Is that satisfactory with other 

9 members of the Work Group?

10 MEMBER ZIEMER: This is Ziemer. 

11 Could you clarify -- I think I have a general 

12 sense of what you're saying, but specifically 

13 what will happen now? Are you talking about 

14 another Work Group meeting to come to 

15 resolution on this issue?

16 CHAIRMAN MELIUS: Right. Yes. 

17 That is a quick sum.

18 MEMBER ZIEMER: But the 

19 extended-period issue is not one that we as a 

20 Work Group or Board can sort of come to 

21 closure on, I don't think. I mean, suppose we 

22 say yes, we think that that is -- well, I 
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1 guess, what exactly are you proposing to do 

2 with that? It wasn't quite clear.

3 CHAIRMAN MELIUS: I don't believe 

4 we can do anything or should do anything on 

5 the covered- period issue. That is the 

6 Department of Labor.

7 All we do is, again, one, if we 

8 have information that is relevant to that that 

9 we find that through other documents or 

10 interviews or something that perhaps NIOSH or 

11 ORAU missed or didn't appreciate, that we 

12 bring it to whoever's attention to be 

13 communicated to Department of Labor, but, you 

14 know, we are not charged with reviewing that 

15 particular issue. And I'm not proposing that 

16 we should.

17 I think at least that is my 

18 understanding of our role.

19 MEMBER ZIEMER: Right. This is 

20 Ziemer again. And then, although it is not 

21 the purview of this particular Work Group, I 

22 think Dr. McKeel's issues on the surrogate 
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1 data will need to be dealt with. And, of 

2 course, the Surrogate Data Work Group is 

3 working to come to closure on the criteria 

4 issue and perhaps that will speak to those 

5 issues as well.

6 I think that is more in our 

7 purview, anyway. We need to put to rest the 

8 issue of use of the surrogate data for this 

9 facility in the covered period, although we 

10 already have an SEC there.

11 CHAIRMAN MELIUS: Right. So it's 

12 not the --

13 MEMBER ZIEMER: So it has to do 

14 with -- well, it would have to do with dose 

15 reconstructions for the non-covered cancers, I 

16 guess.

17 CHAIRMAN MELIUS: But it is also 

18 the residual period.

19 MEMBER ZIEMER: Right. Right.

20 CHAIRMAN MELIUS: Yes. I believe 

21 in --

22 MEMBER ZIEMER: And so far as that 
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1 starting point may be affected by the 

2 surrogate issue.

3 CHAIRMAN MELIUS: Correct. We can 

4 do that. So presumably, if we reach some 

5 better closure on the surrogate data issue at 

6 our meeting next week, I think then we'll 

7 probably have a better idea of sort of 

8 scheduling and how to sort of pull those, sort 

9 of that surrogate data issue matters as well 

10 as the other issues we have been talking about 

11 and can bring some closure to the site, at 

12 least based on the information we have to 

13 date.

14 MEMBER BEACH: Hey, Jim, this is 

15 Josie.

16 CHAIRMAN MELIUS: Yes?

17 MEMBER BEACH: It would be helpful 

18 for me if you could -- I know we are going to 

19 set a date for the next Work Group meeting, 

20 but if you could send out an e-mail kind of 

21 outlining the issues?

22 CHAIRMAN MELIUS: Yes.
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1 MEMBER BEACH: Because it is very 

2 complicated between the surrogate and the 

3 250-day.

4 CHAIRMAN MELIUS: Yes. And maybe 

5 one of the things we want to charge SC&A to do 

6 is to provide that outline as a task to make 

7 sure that we have covered all of the points 

8 that have come up through that. Maybe we can 

9 talk about that at the Board meeting.

10 DR. MAURO: Jim, this is John 

11 Mauro. I would just like to point out with 

12 regard to the surrogate data issue, there have 

13 been specific Site Profile and SEC petition 

14 reviews where we were deliberately tasked to 

15 say, even though the criteria that were 

16 developed, the draft criteria developed by the 

17 Surrogate Data Work Group, were very much 

18 draft, I know we are in the process -- you are 

19 in the process of trying to finalize that as 

20 part of the process to help feed that 

21 decision, those judgments. We did review a 

22 number of documents where we explicitly 
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1 evaluated the degree to which the particular 

2 approach adopted at that facility met or did 

3 not meet the four criteria.

4 That was not done here. I do not 

5 believe it was done here. Bill, who does a 

6 lot of this work, I do not believe we have 

7 ever explicitly compared, okay, here is how 

8 the approach used --

9 CHAIRMAN MELIUS: That is correct, 

10 John.

11 DR. MAURO: -- stacks up here. 

12 Our position in terms of, say, the 1960 time 

13 frame and the use of the uranium information 

14 and the Bay City data for external, I believe 

15 was used, that we did not do a one-on-one 

16 comparison on how it stacks up.

17 Our response, if you recall, 

18 regarding surrogate data was that it was our 

19 general feeling that, given the amount of 

20 material that is historically covering all 

21 time periods, all types of facilities, related 

22 to the machining and handling and rowing and 
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1 extrusion of uranium that is out there, that 

2 there probably exists a pathway where we feel 

3 confident there is a pathway of finding the 

4 right data.

5 Dr. McKeel makes some very 

6 important points. That is, if you are going 

7 to do that, you had sure better make sure you 

8 pick an extrusion facility that didn't have a 

9 hood if you are going to use surrogate data.

10 And I agree with that completely. 

11 That is, you know, checking to see the 

12 applicability and -- which I have to say right 

13 now, I can't say when we looked at this 

14 whether or not we went to that level of detail 

15 to see did the particular surrogate data 

16 adopted take into consideration some of these 

17 factors.

18 So I would like to leave you with 

19 that.

20 CHAIRMAN MELIUS: I appreciate it, 

21 John. Let's see where we are on the surrogate 

22 data issue after our meeting next week. And 
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1 hopefully we'll have some -- I just hesitate 

2 to say we would assign something for when 

3 perhaps the way you would review it would 

4 change or something.

5 DR. MAURO: Correct. That's for 

6 sure.

7 CHAIRMAN MELIUS: Also I think we 

8 need to think about -- there is already an SEC 

9 for the current covered period. And so we are 

10 really talking about the residual period.

11 And so there may be surrogate data 

12 issues related to that. There also may be 

13 surrogate data issues related to the earlier 

14 period. I'm not sure. There's some different 

15 information on that but those who I think 

16 would be probably more -- could be more in the 

17 area of the dose, you know, dose 

18 reconstruction for non-presumptive cancers.

19 MEMBER ZIEMER: Dr. Melius?

20 CHAIRMAN MELIUS: Yes?

21 MEMBER ZIEMER: Ziemer here again. 

22 In terms of evaluating that, I would like to 
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1 insert one other thing. Again, we're sort of 

2 getting off into the surrogate data issue, but 

3 I think one of the points Dr. McKeel mentioned 

4 was what I would classify as a work practice 

5 issue. This is aside from the hardware and 

6 the facility and the hoods and all of that.

7 It is very curious if Dr. 

8 Silverstein indeed was the RSO. I think I 

9 would characterize him as a corporate RSO, 

10 which means he has overall policy calls, even 

11 though he may not have physically been there.

12 It would be very curious as to why 

13 one facility had external monitoring and the 

14 other didn't. One of the surrogate data 

15 issues when we talked about equivalence is not 

16 just the same process, but the work practices 

17 also come into play.

18 I think certainly if SC&A gets 

19 into this, we want to look at that work 

20 practices issue. Was there a conscious 

21 decision not to have external monitoring at 

22 Dow Madison? Because such a decision itself 
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1 says something about maybe an evaluation of 

2 what kind of levels were expected there.

3 I think that has to be part of the 

4 surrogate data evaluation as well. Why were 

5 there different work practices?

6 CHAIRMAN MELIUS: That's a good 

7 point, yes. Thanks. Okay.

8 CHAIRMAN MELIUS: We're now going 

9 to change gears and/or topics and focus on the 

10 250-day issue. I believe that John was going 

11 to sort of give us an overview of where we 

12 have been on this issue.

13 DR. MAURO: Yes. This is John 

14 Mauro. I would be glad to try to do it 

15 briefly. It has quite a history, as you know. 

16 And I have sent out a package of SC&A reports 

17 and also recently what I would call a road map 

18 on all of the minutes, transcripts of the 

19 various Work Group meetings and Board 

20 meetings, where the 250-workday issue was 

21 discussed. In some cases, it was a relatively 

22 brief discussion. In some, it was a very 
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1 elaborate discussion. And I believe everyone 

2 should have gotten that.

3 And hopefully, you know, as 

4 necessary, the page numbers and the dates of 

5 the minutes are all laid out there so that if 

6 we actually start to delve into any one of 

7 these complex discussions, we could quickly, 

8 as necessary, go dive into that particular 

9 section of the transcripts and get 

10 clarification of what transpired.

11 But I will try my best to give you 

12 the broad brush story of the 250-workday issue 

13 and where we are right now. The process first 

14 began by struggling with the very difficult 

15 question of what criteria should be used. We 

16 first thought in terms of we had meetings 

17 where, well, what is equivalent to a 

18 criticality exposure for those who had the 

19 language in the regulation, uncontrolled 

20 exposures, where the types of exposure were 

21 comparable to what one might experience with 

22 criticality.
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1 And that took us down a road that 

2 lasted a while. And we filled out a number of 

3 work products to try to explore that a bit. 

4 We had quite a bit of animated discussion 

5 early on regarding that matter.

6 I think we walked away, this is 

7 really what I walked away with anyway, and I 

8 think it is also in the transcripts, walks 

9 away with, that the exposures that were 

10 experienced in the past on the criticality 

11 situations varied from the millirem range to 

12 the thousands of rem range. You know, we have 

13 a nice report that sort of summarizes all of 

14 the criticality experience.

15 So that really didn't help us very 

16 much except to say that, oh, my goodness, you 

17 know, going down that road, it wasn't too 

18 helpful in terms of zeroing in on can we pick 

19 a dose or a range of doses.

20 But at the same time, I think that 

21 the complex discussions we had went toward 

22 that, well, we all agree that when the doses 
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1 start to exceed around ten rem and start to 

2 approach 100 rem, now we're talking general 

3 acute exposures, whole body, certainly within 

4 the realm of what we believe was the intent 

5 of, might have been the intent of, putting in 

6 that language. And I think we sort of walked 

7 away with that as being one of the places that 

8 would help guide our thinking.

9 We also had lots of discussion on 

10 what about biological endpoints like, did 

11 anyone experience a drop in white blood cell 

12 count. That would be another circumstance 

13 that under uncontrolled circumstances that 

14 might be indicative of a condition that may 

15 warrant a 250-workday consideration.

16 And there is lots of discussion 

17 and nuance on matters like that. I guess we 

18 walked away from that conversation that we are 

19 really not quite sure if we can come up with 

20 something: nice, clean criteria, either 

21 dose-based or based on not dose but maybe 

22 biological endpoints, medical aspects, that 
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1 would really help to make it a clean 

2 decision-making process.

3 So that was really more of what I 

4 would say the high-level discussion, to see if 

5 we could come at this in some general way with 

6 general criteria, sort of what we are doing 

7 right now with surrogate data, come up with 

8 some fundamental principles that will help 

9 guide us, make these decisions.

10 I think, quite frankly, we tried 

11 that, and we found it very difficult. That is 

12 the story that emerges I think in my 

13 recollection of reading of the transcripts.

14 And then we moved into a mode 

15 where we say, okay. Listen. Let's also, in 

16 parallel, while we're entertaining these ideas 

17 also look at some real world examples of where 

18 we might have experienced, where situations 

19 might have occurred that one would say we had 

20 better consider the 250-workday issue here.

21 And it emerged for us -- and we 

22 have reports on this that was part of the 
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1 compilation -- at the Nevada Test Site with 

2 some examples of circumstances that one might 

3 consider to fall within the category.

4 DR. MAURO: We also had the Met 

5 Lab report, Metallurgical Laboratory report, 

6 that more recently came out and prior to that 

7 was the Ames report. In the Ames report, that 

8 raised a lot of very interesting discussion.

9 The Ames report in a nutshell 

10 demonstrated pretty convincingly that there 

11 were multiple blowouts that occurred where 

12 workers likely experienced very high exposures 

13 to airborne concentrations of uranium.

14 And even if they were only exposed 

15 for a relatively short period of time, five 

16 minutes, on that order, a matter of minutes, 

17 the dose commitment, internal dose commitment, 

18 to the lung and perhaps some other organs, 

19 like bone, could have been very high, in 

20 excess of 100 rem. And a lot of discussion 

21 was held during the Work Group meetings.

22 But that is not really an acute 
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1 exposure. So now we get into this dilemma of 

2 is this comparable to something one would 

3 consider like a criticality.

4 SC&A's position was, well, yes. 

5 We are talking about acute, short-term 

6 exposure. You run into this definition of 

7 acute. Is acute the duration of exposure or 

8 is acute the dose rate the dose is delivered?

9 You know, if you are exposed to 

10 external exposure from a criticality, that is 

11 acute in the most narrowly defined terms. You 

12 know, it occurs over a very short time, and 

13 the energy is delivered to every tissue in 

14 your body, almost instantaneously.

15 Ames is different. Ames, yes, the 

16 exposures occurred in a relatively short 

17 period of time, but the inhaled material 

18 that's in your body now is being delivered 

19 over a protracted period of time.

20 And we had a lot of animated 

21 discussion on that that type of exposure 

22 scenario constitutes something that should be 
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1 considered to a 250-workday issue. And we 

2 certainly have not resolved that.

3 I think that goes to the heart of 

4 the matter because I believe we will find that 

5 in many circumstances, when we do encounter 

6 situations where people might have been

7 exposed to fairly high levels of internal 

8 matters for short periods of time, where the 

9 doses might be on the order of tens or even 

10 hundreds of rem to some organs but they are 

11 dose commitments, not acute, short-term 

12 exposures, and we are all struggling with does 

13 that mean that we have a 250-workday issue?

14 That is what emerged from our Ames 

15 work. What emerged from the Met Lab work --

16 and, by the way, the author of both the Ames 

17 report and the Met Lab report was Hans 

18 Behling, and he's on the line.

19 To distinguish, something 

20 different occurred at the Met Lab, which was 

21 very early on, where one could argue that the 

22 radiological setting in terms of health 
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1 physics practices, the kinds of things that 

2 were going on, resulted in some workers who 

3 were there clearly -- and you know this for 

4 certain -- clearly for relatively short 

5 periods of time, much less in 250 days, where 

6 the potential for relatively high external and 

7 internal exposures existed, to the extent that 

8 I believe there are even some workers who 

9 experience a drop in red blood cell count.

10 So here we have a situation where 

11 we're talking about, a little different than 

12 Ames -- Ames was mainly a concern because of 

13 this external exposure from the blowouts. Now 

14 we have a situation where on a day-to-day 

15 basis while people are working at the pile at 

16 the Met Lab. It was so early in the -- and 

17 this, of course, is an SEC-covered period. 

18 Both of these are.

19 But the question is, should there 

20 be consideration of the 250-day issue to the 

21 people at the Met Lab, who, many of them, were 

22 there for relatively short periods of time and 
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1 the nature of the exposures, neutron, external 

2 gamma and internal, one could say, were they 

3 under control? Well, you have to question the 

4 degree to which they were under control 

5 because there was very little knowledge at the 

6 time of good radiological protection 

7 practices.

8 And so I guess I will stop at that 

9 point in terms of characterizing that we have 

10 a circumstance where it is almost as if we 

11 have to -- I'll tell you where I walk away 

12 from this. I say, you know, it is very hard 

13 to make general rules. We would love to be 

14 able to make general rules and guidelines to 

15 help steer us through the application of this 

16 concern on a case-by-case basis, I mean, on an 

17 over-arching guideline the way we are doing 

18 with surrogate.

19 The more I think about this 

20 problem is understanding the circumstances the 

21 way they existed and making judgments. In 

22 this particular case, it is clear and 
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1 unambiguous that large exposures that occur 

2 over a relatively short period of time, 

3 whether they were external or internal, we 

4 really can't put a handle on how high those 

5 exposures are.

6 They were clearly high enough that 

7 they were delivering doses that, whether 

8 they're external or committed, are doses on 

9 the order of levels that everyone agrees are 

10 dangerously high, such as the number that I 

11 have in my head, by the way, is 100 rem.

12 To me if there is any guideline 

13 that I go by that I walk away from after 

14 reading all of this stuff is that if I've got 

15 a circumstance where the potential existed for 

16 organ doses that are on that order, I'm 

17 starting to think, yes, we've got ourselves a 

18 250-workday.

19 I just gave you not only my best 

20 shot at capturing the history of the story 

21 that started, I believe, in 2006 and -- I 

22 apologize. I also gave you a little of what 
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1 my perspective is on how to deal with this 

2 problem.

3 And, with that, Hans, certainly if 

4 there are other aspects to it that you think 

5 that I missed, please help out.

6 DR. BEHLING: Yes. John, I think 

7 you summarized extremely well. And I just 

8 want to say the distance between, really, 

9 criticality events and a short-term exposure 

10 that, however, may require you to manifest 

11 itself in terms of organ dose is really a 

12 difference between perhaps inducing -- both of 

13 them will result in high doses. That's for 

14 sure. But obviously the criticality-type 

15 exposure has a potential of inducing the acute 

16 radiation syndrome.

17 However, as John pointed out, 

18 EEOICPA is not really there to compensate 

19 people for acute radiation syndrome. We are

20 here to compensate people for 

21 radiation-induced cancers and so that being a 

22 difference that I consider is really 
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1 immaterial to the issue that involves the 

2 250-day criteria.

3 COURT REPORTER: This is the Court 

4 Reporter.

5 CHAIRMAN MELIUS: Thank you.

6 COURT REPORTER: Would the person 

7 who spoke please identify himself?

8 CHAIRMAN MELIUS: That's Hans 

9 Behling --

10 COURT REPORTER: Hans Behling?

11 CHAIRMAN MELIUS: -- from SC&A.

12 COURT REPORTER: Okay. Thank you.

13 CHAIRMAN MELIUS: To extend John's 

14 metaphor, we have tried the high road and the 

15 low road. And neither one gets us there yet.

16 DR. MAURO: Well said.

17 CHAIRMAN MELIUS: I would add one 

18 other complication to this that I think came 

19 up in both Ames and the Met Lab situations was 

20 that, even in those situations where I think 

21 everyone sort of understood that some people 

22 -- that the 250-day rule wasn't appropriate 
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1 for people working there in terms of fairly 

2 compensating them or whatever we want to call 

3 that.

4 The other issue that we have to 

5 wrestle with is, well, then, how would you 

6 define the Class? Was it somebody that was 

7 there for one day, one incident, you know, ten 

8 days, a month, or whatsoever?

9 And when you have a series of 

10 discrete incidents that are exposures that 

11 occurred or operations that occurred that led 

12 to the exposure, how do we appropriately 

13 capture that in terms of a Class Definition 

14 for someone there that just captures those? I 

15 think that is a further complication to trying 

16 to come up with a scheme or an approach that 

17 addresses this.

18 Any Board Members have comments or 

19 questions?

20 MEMBER ZIEMER: Well, this is 

21 Ziemer. I will throw in my comments. I have 

22 been giving a lot of thought to this past 
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1 week. I don't have a solution to it. I think 

2 it is a dilemma. Part of the dilemma, of 

3 course, is the fact that we use the 250-day 

4 criteria in a sense to define a break point 

5 between the biological consequences and no 

6 biological consequences, as it were, that is 

7 very arbitrary.

8 What I was trying to think about, 

9 for example, was let's take a place like Ames 

10 where we had the blowouts. I don't recall 

11 whether NIOSH felt like they could bound 

12 those.

13 One of the things -- criticality 

14 incidents are usually fairly straightforward 

15 for bounding anyway, but let's suppose that 

16 you have incidents like the blowouts, where --

17 well, let me ask it this way. Do we have 

18 incidents where we're pretty sure what the 

19 lower end of a bound might be? Let me put it 

20 in as potential.

21 The potential is that you would 

22 get at least some value. Maybe you can't put 
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1 an upper bound on it, but you know it's at 

2 least this amount. Say it's 10 or 20 rem or 

3 something like that.

4 It seemed to me if you could do 

5 that and if we were in a position to pick a 

6 number, like John Mauro talked about. Is 

7 there a dose number where, yes, we agree that 

8 aside from 250, if you've got at least this 

9 much dose, there's health endangerment by 

10 definition and, therefore, if you were at an 

11 incident where that occurred, we would throw 

12 you into the SEC, for example?

13 I am trying to think in terms of 

14 that kind of thing so that if you said, "Okay. 

15 We know that at such and such a site there 

16 were blowouts and if a person could establish 

17 that they were present during the period where 

18 those were known to occur," even if you 

19 couldn't bound them, could you include that? 

20 That is in your identified time periods during 

21 which discrete incidents occurred that were 

22 likely to produce doses above some value or 
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1 that would be one thing.

2 Another thing would be if a person 

3 could establish by medical records that they 

4 got a dose, even if we didn't know what it 

5 was, that resulted in non-stochastic effects, 

6 which are not covered specifically; that is, 

7 the non-cancers, but they are evidence of high 

8 dose, could you include that person as part of 

9 an SEC? Because we know that in many of those 

10 cases where there are non-stochastic effects 

11 years later, there are indeed stochastic 

12 effects.

13 So I have been trying to think 

14 about it in those kinds of terms.

15 CHAIRMAN MELIUS: Again with the 

16 metaphor, I think you are trying to get us 

17 back on the high road, but that actually -- I 

18 mean, my own thinking is maybe not that we --

19 you know, we started out I think with 

20 something similar. I don't think we were 

21 thinking of it as a lower bound, but I think 

22 we were talking about what exposure 
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1 constitutes health endangerment.

2 MEMBER ZIEMER: Well, that is kind 

3 of the issue. And, of course, it is different 

4 for every organ and every age, but on this 

5 thing, to some extent, just like the 250 days 

6 is sort of arbitrary. One might have an 

7 arbitrary guideline that you use to make a 

8 decision.

9 Obviously, you know, what is the 

10 difference if a person is there 249 days, 

11 there is no health endangerment, and 250 there 

12 is? Well, you know, that is just arbitrary. 

13 But it is a decision tool.

14 CHAIRMAN MELIUS: And I actually 

15 like that in that maybe use that as the 

16 decision tool. Then based on the particular 

17 facility that we're dealing with or 

18 circumstances we're dealing with, you can then 

19 sort of develop a Class Definition that would 

20 encompass those at that facility who met that, 

21 qualified in that way.

22 And so it might be different among 
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1 different facilities. And there may be 

2 multiple ways of sort of qualifying to do 

3 that, I mean, the same with the stochastic 

4 effects.

5 And so, I mean, I think there are 

6 other ways of thinking about this. But that 

7 may be a way of approaching this to sort of 

8 combine the high and low roads.

9 MEMBER ZIEMER: This is Ziemer 

10 again. I guess I would like to ask NIOSH, 

11 maybe Jim Neton. Jim, is it conceivable that 

12 one could characterize events in terms of a 

13 lower dose potential, even in cases where you 

14 know you can't get an upper bound but you are 

15 pretty clear that you would have at least a 

16 certain dose or am I thinking about this 

17 wrong?

18 I recognize for chronic things, 

19 you could make the same argument, but we sort 

20 of assumed on a sort of regular facility where 

21 you don't have "incidents," everything is 

22 operating kind of normally, that the 250 days 
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1 gives you a year of exposure. And sort of 

2 intuitively you say, "Okay." That means in a 

3 general sense if they are operating normally, 

4 a person -- it sort of puts them over a five 

5 rem dose if you use that as kind of an 

6 operating -- you know, the limit for typical 

7 operations without acute incidents.

8 The 250 days in my mind kind of 

9 puts you at a five rem cutoff point, that if 

10 you worked more than a year, then possibly you 

11 got above five rem.

12 MR. HINNEFELD: This is Stu 

13 Hinnefeld, Paul. Jim I'm sure has dropped off 

14 the phone because his particular conflict is 

15 affected by the 250 days.

16 MEMBER ZIEMER: Yes.

17 MR. HINNEFELD: So he has dropped 

18 off.

19 MEMBER ZIEMER: Okay.

20 MR. HINNEFELD: With respect to 

21 your question, you asked, are there incidents 

22 where we could say, "Well, if someone were 
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1 present for this incident, the dose would be 

2 at least as high as some number."

3 MEMBER ZIEMER: Yes. That's sort 

4 of what I am thinking about.

5 MR. HINNEFELD: I don't know that 

6 we have ever tried to do that.

7 MEMBER ZIEMER: And then you'd 

8 have to decide what that number was. But 

9 conceptually can you do that?

10 MR. HINNEFELD: Well, you know --

11 MEMBER ZIEMER: And then if the 

12 number is 100, like John Mauro is suggesting, 

13 in my mind I would use a lower number. I 

14 would use like 50, which is kind of the 

15 threshold for non-stochastic effects. But, in 

16 any event, whatever that might be.

17 MR. HINNEFELD: Well, 

18 theoretically there might be some incidents 

19 where we could say that someone could if they 

20 were present for this incident could have been 

21 exposed to at least 50 rem. I think 

22 theoretically that seems to be possible now.
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1 I don't know, though, that when we 

2 start to go down that path, that we will 

3 really be confident that we will be able to 

4 say that.

5 MEMBER ZIEMER: I am just trying 

6 to think of a way to think about this. I may 

7 be completely off on a wild track here, but 

8 I'm trying to deal with an issue that says --

9 I mean, we all feel sort of intuitively that 

10 there are cases where a person wouldn't have 

11 to be around 250 days if they were present 

12 when one of these events occurred.

13 MR. HINNEFELD: I think we would 

14 disagree with that.

15 CHAIRMAN MELIUS: I don't recall 

16 on the Met Lab discussions, but I do recall 

17 with the Ames that I think we were pretty 

18 close to making these types of calculations.

19 I remember at one point Jim Neton 

20 was going to go back and sort of do dose 

21 reconstructions for those people. In fact, I 

22 think SC&A had done some hypothetical 
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1 reconstructions on people just to try to see 

2 where you would end up in terms of dose and so 

3 forth. I don't remember the details of that, 

4 but I think we thought that it was something 

5 that we would be able to do.

6 You know, you are dealing with 

7 issues of sort of bounding because these are 

8 difficult to reconstruct accurately obviously.

9 MR. HINNEFELD: Right, but the 

10 issue is we are talking about incidents we 

11 can't reconstruct --

12 CHAIRMAN MELIUS: Right. So --

13 MR. HINNEFELD: -- because we're 

14 going to be in SEC class. And so I don't know 

15 if we can do a lower bound or not.

16 CHAIRMAN MELIUS: Yes, come close, 

17 I guess. We may not be comfortable with dose 

18 reconstruction. I mean, in fact, at one 

19 point, Ames, we were trying to think, could we 

20 do the dose reconstruction, you know, 

21 essentially come up with a reasonable upper 

22 bound and so forth?
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1 DR. GLOVER: This is Sam Glover. 

2 I did want to mention I think Arjun summarized 

3 it in the SC&A December report that it's a 

4 catch-22 thing. If you can set an upper 

5 bound, you can make it a non-SEC.

6 And so I was thinking, Paul, very 

7 similar to what you were that there may be 

8 circumstances where we can come up with some 

9 number that it's not the upper bound, but it 

10 gives you some feel for the level of hazard, 

11 that it was a big number.

12 MEMBER ZIEMER: Well, yes. I'm 

13 focusing on lower bound here, that if a person 

14 was -- and you would have to place the person. 

15 I mean, it's not like, all right, there was 

16 this event and the person was ten buildings 

17 over.

18 If you can't show that they 

19 weren't -- if you have a situation where they 

20 could have been close enough to the event, 

21 whether it is a blowout or whatever it is, 

22 then you would say, "Well, there is a high 
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1 probably they got at least a certain amount."

2 We don't know what the upper bound 

3 is, but if you had a lower bound, like you 

4 could say, "Well, they certainly would have 

5 gotten at least 50 rem from that event," then 

6 I would say, "Okay. Well, maybe you put them 

7 in."

8 But, again, it is a conceptual 

9 thing. You don't really talk about numbers 

10 unless conceptually you say, "Yes," you can do 

11 it.

12 DR. MAURO: Paul, there is 

13 something very attractive about the way you 

14 are thinking. This is John Mauro speaking. I 

15 didn't think of it this way.

16 In effect, when you think about 

17 the 250-day again, you know, to go back to the 

18 idea that, well, if there is a radiation 

19 protection program, things are under control. 

20 We are managing the work correctly.

21 We are going to be limiting people 

22 to three rem per quarter, really, five rem per 
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1 year, but three rem per quarter was the number 

2 that historically was used, you know, in 

3 trying to keep them under that.

4 So what I am hearing is one 

5 concept could be if there was a circumstance 

6 that arose where a person could have 

7 experienced in a relatively short period of 

8 time more than is the quarterly limit, I mean, 

9 this almost becomes a regulatory driven 

10 philosophy. It means that, first of all, 

11 there was some degree of loss of control. And 

12 that goes towards the language.

13 That may be a good way to get a 

14 handle on this. That goes toward the language 

15 that is currently in the rule; that is, loss 

16 of control. There is a definition of loss of 

17 control, clearly a loss of control where a 

18 person experienced an exposure that was in 

19 excess of radiation protection limit.

20 There are circumstances where 

21 people are allowed to get more than three rem 

22 and a quarter under action conditions where 
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1 people are under controlled conditions go in 

2 that deliberately -- and you know what their 

3 exposures were. They were controlled.

4 If a person for some reason was in 

5 a situation where there was a very real 

6 possibility that he could have experienced 

7 more than three rem in a quarter, that is a 

8 nice place to start to think about this. I 

9 like the way that goes.

10 And now that sort of triggers, 

11 triggers the process in a way. And now, of 

12 course, then if you buy in on that philosophy 

13 that this is the place to trigger when you 

14 start to think about this, the next step 

15 becomes, does that include dose commitment 

16 from internal emitters? I think that is going 

17 to be a very difficult question to deal with.

18 But in theory it should apply if 

19 you adopt that philosophy that there clearly 

20 was obviously a loss of some control because 

21 the person was not supposed to get more than 

22 three rem in a quarter, we have got a 
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1 situation.

2 Now, if it goes to the other side, 

3 where the dilemma comes in, does that bring 

4 you to the place that is comparable to a 

5 criticality? Then, of course, things get very 

6 difficult.

7 The idea of zeroing in on loss of 

8 control and the circus there, I didn't think 

9 about that before. And I, for one, find it an 

10 attractive way to get at this thing.

11 DR. BEHLING: John and I guess 

12 everybody else, this is Hans Behling. That 

13 was the very issue that I was trying to bring 

14 out in the Met Lab report in talking about 

15 tolerance limits.

16 Just for an example, I went 

17 through all series of air concentrations, 

18 internal exposures, et cetera, but, for 

19 instance, in exhibit 1, which is on page 16 of 

20 my report, I cite as one of the examples a 

21 tolerance limit that allowed a person at the 

22 time of the Met Lab operations to be exposed 
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1 for a single day up to 280 microcuries of 

2 iodine-131, which based on the dose conversion 

3 factors would lead you to have an exposure 

4 well over 300 rads to the thyroid. That was 

5 one of the limits.

6 And so when we talk about limits 

7 in terms of contemporary limits, you have to 

8 also realize that those limits have changed 

9 over time and especially when you start out at 

10 the time of the Manhattan Project, where we 

11 talk about limits that, by today's standards, 

12 are some -- one of the comparisons I made was 

13 air concentration limits that were invoked 

14 during the time of the Met Lab, as compared to 

15 contemporary limits defined in units of facts.

16 And for some isotopes, the ratio 

17 between what was allowed then and what is 

18 allowed today was a 50,000-fold difference. 

19 So we have to realize that one of the problems 

20 we have to encounter when we talk about 

21 limits, regulatory limits, as a defining 

22 parameter for this 250-day issue is that it is 
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1 a sliding scale in terms of time-wise.

2 MS. HOWELL: This is Emily Howell. 

3 I just wanted to clarify for the record 

4 something that I think everyone in the Working 

5 Group understands, which is some of the ideas 

6 that you guys are throwing around would 

7 require a rule change. And there is nothing 

8 wrong with that. I think the Agency is 

9 beginning a review process and is open to 

10 hearing those.

11 I just want to be clear with 

12 members of the public who may be interested in 

13 this topic that we are talking about the 

14 scientific issues here. And some of them 

15 would require regulatory changes.

16 I also wanted to clarify that, 

17 again, I think, looking at these questions 

18 scientifically is important, but in terms of 

19 understanding the terms used in the regulation 

20 currently, it is really up to the Department 

21 to interpret the regulation and how they want 

22 to interpret things like criticality.
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1 But that shouldn't limit your 

2 discussion. I just want to be clear with 

3 members of the public and on the transcript.

4 CHAIRMAN MELIUS: Any other 

5 comments? Anybody think that this is not 

6 something worth pursuing?

7 (No audible response.)

8 CHAIRMAN MELIUS: Okay.

9 DR. GLOVER: Hey, Jim, this is Sam 

10 Glover.

11 CHAIRMAN MELIUS: Yes?

12 DR. GLOVER: Just since I wasn't 

13 when you initiated the Work Group -- and I do 

14 want to say that I was very appreciative of 

15 John sending this week a very large package of 

16 information. It was very, very helpful to I 

17 think both Stu and myself.

18 When you set out to -- when you 

19 established this Work Group, was it to define 

20 your parameters of how you were going to look 

21 at the 250 days or to provide guidance to us 

22 or --
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1 CHAIRMAN MELIUS: It was --

2 DR. GLOVER: -- to pick up the 

3 issue? I just want to know what your --

4 CHAIRMAN MELIUS: It's been a long 

5 time, Sam, but it was to provide guidance to 

6 you, I think.

7 DR. GLOVER: Yes.

8 CHAIRMAN MELIUS: But it was how 

9 to deal with particular sites that got 

10 referred to this Committee, where because of 

11 the way the petitions were worded -- I can't 

12 remember going back but also because of when 

13 our review of these places where the SEC 

14 classes were granted, that we had concerns 

15 about the -- was 250 days appropriate?

16 In some cases, the petitioners 

17 raised the issue. I'm thinking of Ames and 

18 Nevada Test Site -- I can't remember -- and 

19 Met Lab. So it came out of that that it was 

20 sort of a continuation of trying to deal with 

21 the SECs there based on the petitions but also 

22 the idea of trying to come up with an overall 
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1 approach, recognizing that there, as Emily 

2 pointed out, are some regulatory 

3 interpretation issues as well as some of the 

4 scientific issues to deal with that. 

5 Actually, my next question was 

6 going to be, again, going back to something 

7 Dr. Ziemer pointed out, though, we usually let 

8 NIOSH take the first steps in addressing these 

9 issues. I am not looking for a commitment 

10 here on the phone, but I think it is something 

11 to think about. I think to move this forward 

12 on a scientific basis, I think that if NIOSH 

13 could develop a sort of background paper or 

14 something addressing this issue, are you 

15 comfortable doing that and we have provided 

16 enough guidance for that.

17 I mean, I guess alternatively SC&A 

18 could, but I guess I get a little concerned 

19 that, I mean, we usually try to let NIOSH take 

20 the first step into this area if we are all 

21 agreeing that it is something that is worth 

22 pursuing and we are really not reacting to any 
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1 other reports or rulings or whatever from 

2 NIOSH.

3 DR. GLOVER: This is Sam Glover. 

4 That is kind of what I was wondering on the 

5 surrogate issue if your guys' recommendations 

6 sort of are "Here are some things we thought 

7 you may want to consider" and then we 

8 responded to that.

9 I apologize. I wasn't part of 

10 that and wasn't sure how you went forward on 

11 that issue.

12 CHAIRMAN MELIUS: Surrogate was a 

13 little bit different in that the Board started 

14 to, through a Work Group, develop criteria. 

15 Then while we were developing criteria, NIOSH 

16 published criteria. We were trying to then 

17 get the two to mesh since that time.

18 MR. HINNEFELD: This is Stu 

19 Hinnefeld --

20 CHAIRMAN MELIUS: This is why we 

21 have been more dealing with specific sites, 

22 trying to address this issue, but as part of 
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1 that coming up with some sort of overall 

2 scheme for addressing it or how it should be 

3 addressed in a more general sense.

4 MR. HINNEFELD: This is Stu 

5 Hinnefeld. We can tank that option. I think 

6 based on the discussion and earlier 

7 discussions and the communications that have 

8 been shared, I think everybody who has 

9 participated recognizes that this is kind of a 

10 difficult question to frame or to put down an 

11 approach that seems consistent that 

12 accomplishes the objective here and still, 

13 though, is somewhat consistent with the facts 

14 and the intent of the regulation, which says 

15 that this is sort of an extraordinary 

16 circumstance.

17 So kind of where we are going here 

18 is that they are quite likely -- and I don't 

19 know that any of us are arguing with this, but 

20 there are circumstances other than 

21 criticalities, where you have this instants 

22 external dose, where you could have sufficient 
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1 possibility of harm, as described in this 

2 program, as we treat it in this program, so 

3 that you would get there in less than 250 

4 days. And so there is a lot.

5 You have talked about taking the 

6 high road and the low road and all roads lead 

7 back to where we started from. So we can try, 

8 and we can come up with something. And I 

9 would think that we might even put some 

10 alternatives in there, like, well, we can do 

11 this or we can do this, those kinds of things.

12 I would hope that that would be 

13 accessible for our effort, for our product, to 

14 not come -- I don't know that we want to come 

15 back with a definitive recommendation here.

16 CHAIRMAN MELIUS: An alternative 

17 to that, Stu -- and maybe this makes it easier 

18 in terms of the regulatory issue -- is maybe 

19 we just schedule a Work Group meeting where we 

20 would sit down and just go through this. I 

21 mean, we all have a framework for it. And 

22 maybe we need to put that framework out and 
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1 some description of it.

2 But then we would just get 

3 together for a day in Cincinnati and sort of 

4 talk it through given we've got a lot of 

5 background, a lot of facts we have developed 

6 already. So I don't think there's a lot of 

7 sort of technical stuff.

8 And maybe doing it in that 

9 setting, rather than -- then producing a 

10 document, appropriate documentation, may be a 

11 better way of --

12 MR. HINNEFELD: Stu Hinnefeld 

13 again. That would certainly be helpful from 

14 our standpoint.

15 CHAIRMAN MELIUS: Yes.

16 DR. MAURO: Jim, this is John 

17 Mauro. I just had a thought that goes toward 

18 the regulatory-driven philosophy that, as a 

19 dimension, as we think about this, I would 

20 like to just put it on the table -- what we 

21 have is if you were to adopt that approach, 

22 the question almost then becomes here we have 
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1 a worker who is there for less than 250 days 

2 and, therefore, is not included within the 

3 cohort that is being compensated who has come 

4 down with a particular cancer.

5 And so, all of a sudden, if 

6 internal is going to be on the table, dose 

7 commitment, the question then becomes for him, 

8 was this worker present at a site where a 

9 situation existed where the potential for --

10 let's say the iodine story that was just 

11 described to us by Hans at the Met Lab. The 

12 issue, then, really is only applicable in that 

13 circumstance to thyroid cancer.

14 Similarly, one can argue that for 

15 a transient, such as the type we have with 

16 blowouts at Ames, if we were going to go with 

17 that, the situation becomes applicable to only 

18 some set of cancers, certainly lung cancer, 

19 perhaps others.

20 What I am getting at is one of the 

21 dimensions of the discussions and the think 

22 piece is, do we start to apply it if we move 
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1 down that road and it becomes cancer-based?

2 That is, the person might have 

3 been present during a given transient that is 

4 documented where we really can't place an 

5 upper bound but we certainly know the 

6 exposures were high, but it would only be of 

7 concern for particular classes of cancer.

8 That is something we have never 

9 discussed before. And I think I would just 

10 like to put that out as something to entertain 

11 as we think through this problem.

12 CHAIRMAN MELIUS: We actually did 

13 discuss it. If I recall correctly, the 

14 original SEC proposal, regulation proposal, 

15 from NIOSH was to do just that, that SECs 

16 would be organ-specific.

17 DR. MAURO: That predates my date, 

18 though. Okay. I understand.

19 CHAIRMAN MELIUS: I don't think it 

20 predates your date, but, anyway, it was a long 

21 time ago. Anyway, not in terms of the 250-day 

22 issue but overall.
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1 DR. MAURO: Oh, the overall. Yes, 

2 yes.

3 CHAIRMAN MELIUS: Overall rem 

4 regulation.

5 DR. MAURO: Got you. Okay.

6 CHAIRMAN MELIUS: I think the 

7 Board's recommendation was not to do it that 

8 way. Again, it doesn't mean we would reject 

9 it out of hand or whatever and consider it.

10 I mean, another way of thinking 

11 about this is that we are already giving -- I 

12 think Dr. Ziemer mentioned this already. You 

13 know, we sort of have sort of the threshold is 

14 the 250-day threshold or maybe it's you, John, 

15 that talked about it a little bit.

16 So I think the other issue is sort 

17 of equity. If we are compensating people 

18 based on their exposure of 250 days, is it 

19 fair to people that in these situations, SECs 

20 that would not have worked 250 days but may 

21 have had sort of similar exposures to not 

22 compensate them and so forth?
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1 Now, I think we think of it that 

2 way. Then it's sort of, how do we approach 

3 it? The more I think about it, the more I 

4 think it may be better just let's have another 

5 Work Group meeting in person where we can all 

6 get together and spend more time and sort of 

7 look through the different possibilities, 

8 rather than try to produce, either NIOSH or 

9 SC&A produce, another document at this point 

10 in time.

11 DR. GLOVER: This is Sam Glover. 

12 I think, Stu, we would be happy to participate 

13 in that. We would be happy to participate 

14 with Stu.

15 CHAIRMAN MELIUS: Hello?

16 MR. HINNEFELD: This is Stu 

17 Hinnefeld. I can hear you.

18 CHAIRMAN MELIUS: Okay. Work 

19 Group members?

20 MEMBER ZIEMER: This is Ziemer 

21 again. I think that is a good approach. We 

22 still have some issues such as this specific 
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1 new client issue that could be discussed, but 

2 to the extent possible, you have to keep it 

3 parallel with the existing SEC regs.

4 CHAIRMAN MELIUS: Yes. I say this 

5 without getting in trouble with Emily, but I 

6 think if we do it -- we are having 

7 discussions. And I think we have a little 

8 wider latitude in terms of what we are talking 

9 about. And then if it requires a change in 

10 the regulations, that is something that could 

11 be considered.

12 But let's sort of focus on the 

13 issue and how we may come up with something 

14 that would be workable and fair in this area, 

15 rather than trying to produce a report and 

16 worry about, well, how does that fit into the 

17 regulations or whatever at this --

18 MS. HOWELL: I think to sort of 

19 respond a little bit to Dr. Ziemer's concern 

20 and Dr. Melius -- this is Emily -- I think 

21 that you guys are certainly, the Board is 

22 certainly, within its rights, if it determines 
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1 that a different framework would be helpful 

2 that is not within the rule. You know, you 

3 can always send a letter to the Secretary with 

4 the results of your work and the basis for it.

5 I know you will be hearing a 

6 little more next week about a program review 

7 that NIOSH is undergoing. So these kinds of 

8 discussions, I mean, I think it is up to the 

9 Working Group and NIOSH to figure out if you 

10 want to come up with options that are within 

11 the rule versus that would require a rule 

12 change, but, again, these are questions that 

13 our office may have to see kind of what you 

14 come up with and figure out.

15 We are not going to be able to for 

16 everything necessarily give you an extant 

17 answer of whether or not something is 

18 envisioned by the rule and would be allowed 

19 under the current rule framework.

20 DR. NETON: Yes. That's a good 

21 point. What I would see us doing is 

22 developing sort of the options or the 
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1 approaches. And then they would have to be 

2 looked at from a legal issue, regulatory 

3 issue, as to whether they fit or not or could 

4 be fitted or whatever.

5 MEMBER GRIFFON: Jim, this is Mark 

6 Griffon. I agree it would be good to do this. 

7 I think it might be useful, too, if we can 

8 find the discussions that you reference 

9 because I do remember there were discussions 

10 early on and discussions around the time when 

11 the Board was commenting on the SEC 

12 regulation. I think if you find those 

13 transcripts and maybe pull them together for 

14 the Work Group members all in one spot, it 

15 might be useful in terms of not --

16 CHAIRMAN MELIUS: Yes.

17 MEMBER GRIFFON: I feel a little 

18 déjà vu in these conversations. So to the 

19 extent that we have had some of these 

20 discussions, it might help us when we're 

21 trying to pull it all together into some 

22 policy options.
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1 MEMBER ZIEMER: Jim, this is 

2 Ziemer again. Am I online or am I --

3 CHAIRMAN MELIUS: You are online.

4 MEMBER ZIEMER: Okay. I always 

5 forget which button I pushed.

6 CHAIRMAN MELIUS: Right. I have 

7 the same problem.

8 MEMBER ZIEMER: I might point out 

9 I just received this week a letter from 

10 Senator Reid. I don't know. Ted, did that 

11 get distributed to the Board yet?

12 But, in any event, he specifically 

13 requested that the Board take another look at 

14 the 250-day issue, in any event. And I think 

15 we want to be responsive to that request to 

16 the extent possible as well.

17 So I think what Dr. Melius has 

18 suggested would certainly in fit in with that 

19 request that we got from Senator Reid to 

20 address the 250-day issue as well.

21 MR. KATZ: Paul? Paul, this is 

22 Ted. I just went off with one of the Board 
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1 Members.

2 I did receive that, I think 

3 yesterday, late. I was already away out of 

4 the office. And I forwarded it to the whole 

5 Board by Blackberry, but a couple of times I 

6 got failed messages. I don't know whether 

7 it's failed to go to everyone or just failed 

8 to go to perhaps one Board Member.

9 MEMBER ZIEMER: Well, in any 

10 event, we will be distributing that. But I 

11 just wanted to point out that we do have a 

12 congressional request, actually, to study this 

13 issue further. So I think it's appropriate.

14 MR. KATZ: Right.

15 CHAIRMAN MELIUS: It failed to get 

16 to me, Ted.

17 MR. KATZ: Okay. Then it probably 

18 failed generally.

19 MEMBER ROESSLER: This is Gen. I 

20 didn't get it.

21 MR. KATZ: Okay. Then I know that 

22 there is no way for me to remedy this without 
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1 being out of the office right now.

2 CHAIRMAN MELIUS: We understand, 

3 Ted. Thanks. Good.

4 Okay. I think we've reached the 

5 end of our meeting. What I will do is when we 

6 are in Los Angeles next week, I think we can 

7 work on scheduling a meeting of this Work 

8 Group. It will be an in-person meeting in 

9 Cincinnati. And we will go on from there.

10 I would like to thank everybody, 

11 NIOSH and SC&A, for their input and 

12 involvement; Dr. McKeel, earlier when we were 

13 talking about Dow; and, obviously, the Work 

14 Group members. And we'll see everybody in Los 

15 Angeles next week.

16 MEMBER ZIEMER: Great. Thank you.

17 (Whereupon, the above-entitled 

18 matter went off the record at 12:05 p.m.)

19 

20 

21 

22 
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