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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR DISEASE CONTROL

NATIONAL INSTITUTE FOR OCCUPATIONAL

SAFETY AND HEALTH

+ + + + +

ADVISORY BOARD ON RADIATION AND

WORKER HEALTH

+ + + + +

WORK GROUP ON THE USE OF SURROGATE DATA

+ + + + +

MONDAY

JANUARY 11, 2010

+ + + + +

The Work Group meeting convened by 

teleconference at 1:00 p.m. Eastern Standard 

Time, James M. Melius, Chairman, presiding.

PRESENT:

JAMES M. MELIUS, Chairman

JOSIE BEACH, Member

MARK GRIFFON, Member

JAMES E. LOCKEY, Member

WANDA I. MUNN, Member

PAUL L. ZIEMER, Member
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ALSO PRESENT: 

TED KATZ, Designated Federal Official

NANCY ADAMS, NIOSH Contractor

TERRIE BARRIE, ANWAG

HANS BEHLING, SC&A

TOM BOLIN

ANTOINETTE BONSIGNORE, Petitioner, Linde

NICOLE BRIGGS, SC&A

DENISE BROCK, NIOSH

JASON BROEHM, CDC

WILLIAM FRANKLIN

EMILY HOWELL, HHS

JENNY LIN, HHS

ARJUN MAKHIJANI, SC&A

JOHN MAURO, SC&A

ROBERT McGOLERICK, HHS

DAN McKEEL, Petitioner, Texas City

FREDDY MORGAN, JR.

JAMES NETON, NIOSH OCAS

ANITA PORTER, for Nelson Porter

JOHN STIVER, SC&A

BILL THURBER, SC&A
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T-A-B-L-E O-F C-O-N-T-E-N-T-S

Roll Call 5

Surrogate Data Discussion 11

Adjourn 92
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1 P-R-O-C-E-E-D-I-N-G-S

2 (1:03 p.m.)

3 MR. KATZ: This is the Advisory 

4 Board on Radiation Worker Health, the 

5 Surrogate Data Working Group. My name is Ted 

6 Katz and I am the Designated Federal Official 

7 of the Advisory Board.

8 And as always, we begin these 

9 meetings with a roll call. Jim, I'm correct, 

10 right, we're not really treating any 

11 individual site. Is that correct? We don't 

12 need a conflict of interest -- okay. Well, 

13 roll call beginning with Board members. 

14 Right. And before we do that --

15 MEMBER ZIEMER: Are these Board 

16 members signing in?

17 MR. KATZ: Yes. Everybody who is 

18 not speaking as a group at this time, would 

19 you please mute your phones. If you don't 

20 have a mute button, I know there is a member 

21 or two from the public on the phone, you use 

22 the *6 on your phone. That will mute your 
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1 phone if you don't have a mute button. And 

2 then when you want to speak to the group, you 

3 use *6 again and you can speak again.

4 And also let me say to everybody 

5 now please don't put your phone on hold at any 

6 point. Just disconnect and call back in if 

7 you need to go away for a bit.

8 Okay. So roll call beginning with 

9 Board members.

10 MEMBER MUNN: This is Wanda. I 

11 must say that the previous speaker expressed 

12 my feelings exactly.

13 MEMBER LOCKEY: Jim Lockey.

14 CHAIRMAN MELIUS: Jim Melius.

15 MEMBER ZIEMER: Paul Ziemer.

16 MEMBER GRIFFON: And Mark Griffon.

17 MR. KATZ: Okay. Josie Beach, are 

18 you on mute?

19 MEMBER BEACH: Can you hear me?

20 MR. KATZ: Now I can, yes.

21 MEMBER BEACH: Okay. This is 

22 Josie Beach. I'm here.
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1 MR. KATZ: All right. Then moving 

2 on to NIOSH-ORAU team.

3 DR. NETON: Yes, this is Jim Neton 

4 in Cincinnati from NIOSH.

5 MR. KATZ: Okay. Anyone else from 

6 NIOSH ORAU team?

7 MS. BROCK: This is Denise in St. 

8 Louis.

9 MR. KATZ: Denise Brock.

10 MS. PORTER: Yes, this is Anita 

11 Porter for Nelson Porter from Texas City, 

12 Texas.

13 MR. KATZ: Wait, wait, now we're 

14 just getting people who are working for the 

15 program. But we'll come to the public soon.

16 MS. PORTER: Oh, okay.

17 MR. MORGAN: Okay. My name is 

18 Freddy Morgan, Jr.

19 MR. KATZ: No, we're just asking 

20 for roll call among people who are with the 

21 government right now.

22 MR. MORGAN: Oh, okay. So you'll 
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1 --

2 MR. KATZ: We'll get to you 

3 shortly.

4 So Denise Brock, that's it for 

5 NIOSH-ORAU team.

6 How about SC&A?

7 MR. MORGAN: Oh, okay. You are 

8 going to call me or do you want me to call you 

9 back?

10 DR. MAURO: This is John Mauro 

11 from SC&A.

12 MR. MORGAN: Oh, okay. Okay. All 

13 right, then. Thank you, sir.

14 MR. KATZ: Anyone else from SC&A?

15 MR. THURBER: Yes, Bill Thurber 

16 from SC&A.

17 DR. MAKHIJANI: Arjun Makhijani 

18 from SC&A.

19 DR. BEHLING: Hans Behling, SC&A.

20 MR. KATZ: I'm sorry, you're all 

21 talking -- stop, stop, you're all talking over 

22 each other and I can't make out one person 
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1 from another. I have John Mauro and Arjun 

2 Makhijani. Someone was in between?

3 MR. THURBER: Bill Thurber.

4 MR. KATZ: Bill Thurber.

5 MS. BRIGGS: And Nicole Briggs.

6 DR. BEHLING: Hans Behling.

7 MR. STIVER: John Stiver.

8 MR. KATZ: Okay. Is that it for 

9 SC&A?

10 (No response.)

11 MR. KATZ: Okay. Then other HHS 

12 or other government employees or contractors?

13 MS. HOWELL: Emily Howell, HHS.

14 MS. LIN: Jenny Lin, HHS.

15 MS. ADAMS: Nancy Adams, NIOSH 

16 contractor.

17 MR. McGOLERICK: Robert 

18 McGolerick, HHS.

19 MR. BROEHM: Jason Broehm, CDC.

20 MR. KATZ: Okay. And then how 

21 about any -- either members of the public or 

22 staff of Congressional offices who want to 
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1 identify themselves. You don't have to 

2 identify yourselves but if you want to.

3 DR. McKEEL: This is Dan McKeel. 

4 I'm the co-petitioner for Texas City.

5 MS. BARRIE: Terrie Barrie with 

6 ANWAG.

7 MR. FRANKLIN: This is William 

8 Franklin from Hitchcock, Texas.

9 MR. BOLIN: Tom Bolin, Columbia, 

10 South Carolina.

11 MS. BONSIGNORE: Antoinette 

12 Bonsignore for Linde Ceramics.

13 MR. KATZ: Okay, then. Let me 

14 just remind, again, everyone in the public. I 

15 can hear a lot of background noise which 

16 suggests to me a lot of people's phones are 

17 not on mute. Please mute your phones. If you 

18 don't have a mute button, use *6. And then 

19 use *6 again if you want to come back to 

20 actually address the group. Thank you.

21 MEMBER ZIEMER: Dr. Melius? This 

22 is Ziemer. Could I ask a question before you 
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1 get underway?

2 One of the questions Ted asked was 

3 whether or not any sites are being discussed 

4 in this meeting for purposes of us identifying 

5 conflicts of interest. I think you said no 

6 but we do have some materials that were sent 

7 by Dr. McKeel for -- regarding Texas City 

8 Chemical. Is that going to be on the agenda 

9 or not?

10 CHAIRMAN MELIUS: I was -- this is 

11 Jim Melius -- I was going to reference that. 

12 But since we got that late last week and my 

13 attempts to follow up on that and address some 

14 of the questions that Mr. McKeel -- Dr. McKeel 

15 raises, we don't have information back. And 

16 so I don't think we can really do justice to -

17 -

18 MEMBER ZIEMER: Yes, well, I just 

19 wanted to make sure in terms of the conflict 

20 question --

21 CHAIRMAN MELIUS: Yes.

22 MEMBER ZIEMER: -- whether we 
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1 would be discussing Texas Chemical --

2 CHAIRMAN MELIUS: Yes.

3 MEMBER ZIEMER: -- at all.

4 CHAIRMAN MELIUS: It's actually 

5 why I waited and didn't put out the agenda 

6 until -- ended up not putting out one because 

7 I was waiting to see if we would hear back and 

8 I've inquired of Ted and others trying to 

9 figure out what is going on. But we just 

10 don't -- I don't think I have enough 

11 information back --

12 MEMBER ZIEMER: Okay.

13 CHAIRMAN MELIUS: -- to do justice 

14 to it.

15 MEMBER ZIEMER: Thank you.

16 MR. KATZ: So, Jim, Dr. Melius, 

17 it's yours.

18 CHAIRMAN MELIUS: Okay.

19 Good afternoon or good morning, 

20 depending on where you are. And welcome to 

21 the fourth or fifth meeting of the Surrogate 

22 Data Work Group. And today we're going to 
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1 focus on surrogate data in a general sense. 

2 This is an issue -- as I said, we're not going 

3 to discuss any specific sites but, in essence, 

4 we end up discussing many different sites 

5 potentially when we have these discussions 

6 because of the use of surrogate data at many 

7 different sites in terms of dose 

8 reconstruction and SEC review. So we 

9 understand everyone's interest in the subject.

10 It's also a subject that is under 

11 the purview or review of a lot of different 

12 groups within the Board, a lot of different 

13 Work Groups. And so some of that is confusing 

14 at times in terms of keeping track of and 

15 we'll be referring to documents and comments 

16 that have come up in the context of other Work 

17 Groups and there is ongoing review in other 

18 Work Groups of this issue or of sites related 

19 where this issue is important of that.

20 I thought a way of starting the 

21 discussion and sort of reminding us of this 

22 issue and where we've come and so forth to go 
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1 back to one of the early documents that SC&A 

2 put together, which was their sort of 

3 inventory of the use of surrogate data. It 

4 goes back to 2007 but I think it is still 

5 useful to sort of remind us of the scope of 

6 the use of surrogate data.

7 And, John Mauro, if you wouldn't 

8 mind sort of giving us a quick overview of 

9 that document and then any updates that you 

10 would have?

11 DR. MAURO: Sure. I'd be glad to.

12 Good afternoon, everyone. One of 

13 the first work products that SC&A was 

14 requested to prepare to sort of get the 

15 thinking started on surrogate data was what I 

16 call a compendium of information whereby there 

17 was a report prepared. I believe all the 

18 members of the Work Group have received a 

19 package of the various reports that SC&A has 

20 prepared, one of which is this compendium. 

21 It's 2007. I'm in the process of opening my 

22 file on this.
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1 It's titled NIOSH Site Profile 

2 Surrogate Data Survey. It is a PDF file. And 

3 it is dated September 12th, 2007. And it was 

4 Privacy Act cleared on December 21st, 2007. 

5 So it is a document that can be distributed if 

6 it has not already been distributed.

7 What was done at that time was to 

8 review the Site Profile reviews and the dose 

9 reconstruction audits that SC&A had completed 

10 to that date and try to capture places where 

11 surrogate data was used in its various forms. 

12 And one of the things, in brief, we found 

13 that it is possible to sort different ways in 

14 which you could talk about surrogate data. 

15 And I called them Type 1 versus Type 2.

16 And what we basically did is we 

17 prepared a series of tables, which identified 

18 those sites or those dose reconstructions 

19 where Type 1 surrogate data was used. By Type 

20 1, I mean places where bioassay or film badge 

21 data or air sampling data were used from one 

22 facility to supplement the data for another 
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1 facility for the purpose of dose 

2 reconstruction.

3 We called it Type 1 because that 

4 is really the primary place. That is the kind 

5 of data that is most directly relevant. And, 

6 of course, it is of primary interest to the 

7 Work Group. It is when you may take bioassay 

8 data from one facility, air sampling data from 

9 a facility and then use that data somehow to 

10 reconstruct doses for workers at a different 

11 facility.

12 So -- and there's a whole -- I 

13 won't go into them but there is a long list in 

14 these tables that we provided of where we 

15 found such use of surrogate data in Site 

16 Profiles and dose reconstructions.

17 In the very same table, I have 

18 another column called Type 2. These are 

19 places where it is less direct, where, for 

20 example, there may be certain information that 

21 is of more of a generic nature that is being 

22 applied. It is not bioassay data. It's not 
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1 air sampling data. But it might be other 

2 types of information that is taken from the 

3 open literature or taken from a site which is 

4 not bioassay, it's not air sampling, it's not 

5 film badge data, but it is other data related 

6 to experience at another site that is of use 

7 in performing dose reconstructions.

8 And I'm looking at the table now. 

9 And it was somewhat of a judgmental call of 

10 what to drop into Type 1 versus Type 2. But, 

11 in general, if there is an assumption made and 

12 a calculation that is more of a neutron to 

13 photon ratio, I think that would be a perfect 

14 example of what I call a Type 2 data where 

15 there is widespread information from the 

16 weapons complex on neutron to photon ratios 

17 for reactors versus plutonium handling 

18 facilities versus various types of facilities 

19 where there is some experience.

20 And there are occasions when you 

21 could say okay, from the experience at this 

22 facility on neutron to photon ratios, it might 
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1 be useful in helping to reconstruct doses at 

2 another facility. There are a number of 

3 parameters like that -- minimally detectable 

4 levels of neutron exposure, MDLs.

5 Medical X-ray default assumptions 

6 regarding exposures to occupational medical X7 ray, these are all what I would call Type 2. 

8 So in effect -- and I'll cut this off at this 

9 point -- this table is a compendium of 

10 examples of where, at that point in time, SC&A 

11 had observed Type 1 and Type 2 uses of 

12 surrogate data.

13 And it was a starting point to 

14 start to get a feel of the extent and the 

15 nature that surrogate data is being used on 

16 the program.

17 CHAIRMAN MELIUS: Thanks, John.

18 I'll just sort of point out two 

19 things there. One is that -- strikes me is 

20 really where we have, I think, what we are 

21 reviewing and have been discussing and 

22 probably what is controversial, we've had 
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1 disagreements among Board members and so forth 

2 of how to apply it has been in the area of 

3 Type 1 --

4 DR. MAURO: Yes.

5 CHAIRMAN MELIUS: -- not Type 2. 

6 And I don't think that is always clear in some 

7 of our discussions on this. And I think it is 

8 sort of an important point to keep in mind.

9 Secondly, I think although a lot 

10 of our discussions and focus have been on two 

11 areas of the use of surrogate data, one has 

12 been use of radon data, the other is in the 

13 uranium processing facilities, there are a 

14 number of other areas where it has been or is 

15 being used within the OCAS program.

16 So we are talking about areas that 

17 go beyond just radon, go beyond just the 

18 uranium processing facilities. So I think we 

19 need to keep in mind that it is a broader use 

20 of it. And I think how we approach it, at 

21 least to some extent, needs to keep in mind 

22 that there are these other areas where it is 
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1 utilized.

2 Does anybody else have any 

3 additional comments on the Board?

4 MEMBER ZIEMER: Yes. Are you 

5 going to get to the other SC&A document as 

6 well --

7 CHAIRMAN MELIUS: Yes, I am.

8 MEMBER ZIEMER: -- Dr. Melius --

9 yes. This one is more of a compilation rather 

10 than dealing with the issues per se, I think, 

11 isn't it?

12 DR. MAURO: That is correct.

13 MEMBER ZIEMER: I mean you've 

14 identified how it is being used pretty much in 

15 this first document.

16 DR. MAURO: Yes, Paul, this is 

17 John. Yes, that was, at the time, which was 

18 back in 2007, just to get a feel of how --

19 MEMBER ZIEMER: Right.

20 DR. MAURO: -- surrogate data is 

21 being used and the extent to which it is being 

22 used.
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1 By the way, of course, a lot has 

2 happened since 2007. And there are many, many 

3 more examples that could be laid into the 

4 table. But it was the experience we had as of 

5 that date.

6 CHAIRMAN MELIUS: Any other 

7 comments or questions from the Board?

8 MEMBER MUNN: I guess -- this is 

9 Wanda -- Jim, I would just question whether 

10 you are making any implication with respect to 

11 these Type 2 uses. Are we just simply saying 

12 they exist?

13 CHAIRMAN MELIUS: I think we're 

14 just saying that they exist. I suspect that 

15 many of those uses as you are glancing through 

16 it have been reviewed or are being reviewed by 

17 your Work Group or the Subcommittee on 

18 Procedures. It seems that that is where they 

19 would fall.

20 But just, I think, reminding us 

21 that, I think, where we focused and feel that 

22 there is, you know, we needed to develop some 
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1 criteria then in the Type 1 area.

2 MEMBER ZIEMER: And this is Ziemer 

3 again. And I agree with that. I think that, 

4 for example, on the medical dose 

5 reconstructions, I don't think there's 

6 typically been much question about those other 

7 than sometimes the question as to whether or 

8 not it's fluoroscopy or radiography that was 

9 used.

10 But in general, if you say that, 

11 for example, that radiography was used and you 

12 have the information on the milliamp seconds 

13 that were used typically in a certain time 

14 period and, you know, the size of the chest X15 rays, those are fairly straightforward use of 

16 surrogate data that I don't think that -- the 

17 Board hasn't really been that concerned about 

18 it because it is a pretty straightforward, you 

19 know, medical X-ray within those parameters is 

20 pretty much the same wherever it is done.

21 And they have been using, you 

22 know, the worst case kinds of the -- I mean 
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1 obviously you get different chest X-ray 

2 outputs from different places but you can take 

3 worst cases and use those.

4 CHAIRMAN MELIUS: Right. And I 

5 also think there that assumptions about the 

6 frequency of the surveillance X-rays probably 

7 are as important as assumptions about --

8 MEMBER ZIEMER: Right, right.

9 CHAIRMAN MELIUS: -- those 

10 exposures from a single X-ray --

11 DR. MAURO: Jim, this is John 

12 Mauro. I would like to add one point, 

13 something that was not captured in the 

14 compendium, is that there have been a number 

15 of very important procedures that have been 

16 issued subsequent to this that go toward this 

17 question.

18 I can think of two. One is OTIB19 0054, I believe it is, which is a generic 

20 approach for reconstructing doses at reactor 

21 facilities when you only have gross beta gamma 

22 in urine. In other words, very often the only 
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1 information you have is a very simple gross 

2 beta gamma measurement of a urine sample. And 

3 you have to allocate radionuclides. So what 

4 the distribution of radionuclides might be 

5 that the person inhaled.

6 And I would consider this to be a 

7 type of surrogate data because, in effect, 

8 generic approaches come up whereby if you know 

9 the type of reactor a person may have worked 

10 at and you have some gross beta gamma 

11 information, there is a look-up table in OTIB12 0054 that will help you navigate you way 

13 through doing dose reconstruction.

14 And similarly, TBD-6000 and 6001, 

15 which deals with uranium and thorium metal 

16 handling and processing facilities, provides a 

17 great deal of compendium of information on 

18 what are air dust loadings to assume if you 

19 are confronted with a real uranium handling or 

20 processing facility where you don't have 

21 sufficient data. 

22 And so these are two very 
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1 important, I would say, procedures and TBDs 

2 that we did not capture in our compendium but 

3 very much go toward the question of surrogate 

4 data.

5 CHAIRMAN MELIUS: Yes, John, one 

6 question I have. And that's OTIB-0054, I'm 

7 not familiar with at all -- 6000 and the 

8 appendices to 6000, I'm more familiar with --

9 but with 0054, would you consider a Type 1 or 

10 a Type 2? In hearing you describe it, I 

11 almost thought it was more of a Type 2.

12 DR. MAURO: That's a judgment 

13 call.

14 CHAIRMAN MELIUS: Yes.

15 DR. MAURO: In my judgment, I 

16 would call it Type 1 because what it does is 

17 it allows you to reconstruct bioassay 

18 basically. My breakpoint is if the 

19 methodology directly goes toward bioassay 

20 results, external dosimetry results, or air 

21 sampling results.

22 In a way, I guess the OTIB-0054 is 
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1 a way for you to sort out your bioassay 

2 information. You know it's sort of -- it is a 

3 difficult one to split whether you -- and it's 

4 a judgment call whether you would drop that as 

5 a Type 1 or a Type 2.

6 MEMBER ZIEMER: But -- this is 

7 Ziemer again -- could I just ask the question 

8 there, John, you are talking about cases where 

9 they have actual bioassay data for that 

10 reactor.

11 DR. MAURO: Yes.

12 MEMBER ZIEMER: But so that 

13 wouldn't be surrogate data then.

14 DR. MAURO: Well, they have 

15 bioassay data but it is in a gross beta gamma 

16 form. And you have to figure out a way to 

17 assign what the radionuclide distribution is.

18 MEMBER ZIEMER: Yes, I understand 

19 that. And you are saying it is surrogate data 

20 in the sense that you use the experience of 

21 other reactors where they have had a similar 

22 distribution --
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1 DR. MAURO: Yes.

2 MEMBER ZIEMER: -- of the 

3 nuclides.

4 DR. MAURO: Yes.

5 MEMBER ZIEMER: Yes.

6 DR. MAURO: It's completely, you 

7 know, a judgment call on whether you would 

8 consider that something within the Type 1 or 

9 Type 2. But I thought it was important to 

10 bring it up because it was one of those areas 

11 that form that gray area. And we should be 

12 aware of these distinctions.

13 MEMBER MUNN: But it is using 

14 known science just as we use known science 

15 every day. Making biscuits or making medical 

16 diagnosis or doing dose reconstructions, we're 

17 using known science.

18 CHAIRMAN MELIUS: But I think 

19 we're talking about what is the criteria for 

20 what known science will we use and when will 

21 we apply it. I think that's the issue to 

22 that. But I actually think the distinction 
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1 between the Type 1 and Type 2 is important. 

2 And I guess, again, the same reaction with Dr. 

3 Ziemer that it seemed that OTIB-0054 -- which 

4 again, I'm not familiar with -- it sounded 

5 more like a Type 2 situation.

6 DR. MAKHIJANI: Jim, this is 

7 Arjun.

8 CHAIRMAN MELIUS: Yes?

9 DR. MAKHIJANI: I think, you know, 

10 we recently had a look at this same issue in 

11 the Nevada Test Site because NIOSH said it is 

12 hard to interpret fission product and beta 

13 data for NPF workers. And partly the time of 

14 sample relative to the time of exposure was 

15 not known and there are so many short-lived 

16 fission products.

17 And some of that reasoning may 

18 apply here in that you need to know the time 

19 at which the sample was collected. And then 

20 presumably you could run a computer model for 

21 that reactor. But you couldn't find the mix 

22 of fission products for the bioassay sample 
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1 unless you knew the times. So maybe you would 

2 resort to something more generic if you don't 

3 know that.

4 DR. MAURO: Yes. Well, that's one 

5 of the challenges of surrogate data, 

6 certainly.

7 CHAIRMAN MELIUS: Yes. And, 

8 Arjun, I guess like in thinking about it that 

9 way and it's not just thinking about it in 

10 terms of TBD-6000 appendices, is there are 

11 differences among the sites in terms of what 

12 data is available to use --

13 DR. MAKHIJANI: Yes, I think --

14 CHAIRMAN MELIUS: -- from the 

15 site. And then how much -- sort of the extent 

16 to which surrogate data needs to be used at 

17 that site. And these are all, I think, very 

18 dependent on what kind of dose you are trying 

19 to model, the situation where, you know --

20 because obviously they can range over a wide 

21 range in terms of the complexity of the 

22 situation and how much information is 
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1 available to be able to extrapolate from.

2 DR. MAURO: Jim, if you really 

3 want to make a -- one of the problems you have 

4 is if you really want to make a really clean 

5 break between Type 1 and Type 2, and we can do 

6 that, and interpret Type 1 in its narrowest 

7 sense -- in other words it's just a way to 

8 kick the discussion so that it doesn't blur 

9 lines -- if you are directly using bioassay 

10 data or directly using air sampling data or 

11 directly using film badge data from one site 

12 to sort of supplement the data or use those 

13 measurements and interpret that as Type 1, 

14 then I would say 0054 -- OTIB-0054 is clearly 

15 then Type 2 because, you know, it is one step 

16 removed from that.

17 So I mean it may be easier for the 

18 sake of this discussion in order to create a 

19 nice, strong, clean boundary between Type 1 

20 and Type 2, and certainly that doesn't mean 

21 we're not interested in OTIB-0054 -- but I 

22 mean perhaps the greatest interest right now 
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1 is when you take air sampling data from one 

2 site and you use it at another site. That 

3 would be the classic radon question, for 

4 example.

5 Maybe just for the sake of this 

6 discussion, it is easier to make a bright 

7 line. And that bright line can be drawn.

8 CHAIRMAN MELIUS: Yes, I know, I 

9 think in a lot of our discussions, we're 

10 assuming that that -- what you say, that that 

11 bright line -- and I think trying to keep the 

12 focus here on the -- should I say the purer 

13 Type 1 situation though given the complexity 

14 of these situations, it can be hard to figure 

15 out where the line is and so forth.

16 Any other comments or questions?

17 (No response.)

18 CHAIRMAN MELIUS: Okay. What I 

19 thought would be useful is the other document, 

20 given how much paper there is out there on 

21 this, is to then go ahead and John, if you 

22 would like to talk about your review of the 
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1 NIOSH surrogate data document?

2 DR. MAURO: I'll be very brief. 

3 We delivered to the Board -- this was not a 

4 Work Group product but it was a full review of 

5 OCAS-IG-004. This is the procedure that was 

6 issued by NIOSH entitled The Use of Data from 

7 Other Facilities in the Dose Reconstruction 

8 Under EEOICPA.

9 It is a formalization of NIOSH's 

10 position regarding under what conditions can 

11 you use surrogate data in the strict sense 

12 that we just provide. And SC&A was tasked 

13 with reviewing that. Our deliverable, the 

14 date of delivery was March 30th, 2009. And I 

15 believe the document was cleared for -- was PA 

16 cleared.

17 Well, let me make sure -- no, I'm 

18 not 100 percent certain of that because I'm 

19 looking at the document right now on my page. 

20 And I don't see a place where it says PA 

21 cleared.

22 MR. KATZ: John, that's correct. 
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1 It is PA cleared.

2 DR. MAURO: It has or has not?

3 MR. KATZ: It has been cleared, 

4 yes.

5 DR. MAURO: Oh, very good. Thank 

6 you.

7 See, without getting into the 

8 details of it but in effect what the most 

9 important thing, I guess, we did was look at 

10 the criteria that NIOSH set forth. And they 

11 had a number of criteria for how to -- when 

12 and where, under what conditions surrogate 

13 data can be used.

14 And we reviewed it -- and we 

15 performed a review of that document. And we 

16 reviewed it. This is a subtlety that is 

17 important to follow. We reviewed it purely 

18 from the point of view of Part 82. In other 

19 words, Part 82 provides direction in the 

20 regulations for dose reconstruction and how to 

21 go about doing dose reconstruction.

22 And we reviewed OCAS-IG-004 from 
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1 the point of view of compatibility of these 

2 protocols with the provisions of Part 82 as 

3 opposed to Part 83 where there is some 

4 specific language regarding surrogate data. 

5 So this is what I would call strictly a review 

6 of the degree to which we felt technically 

7 NIOSH has identified all of the salient issues 

8 that we think are very important when you are 

9 going to use surrogate data within the context 

10 of -- you know, to do dose reconstructions in 

11 accordance with Part 82.

12 And we had a number of findings. 

13 Hans Behling did all of the heavy lifting and 

14 hard work on this. And there are a list of 

15 seven findings that are right there in the 

16 Executive Summary. I believe everyone has 

17 that. But, you know, I guess -- and we also 

18 made a comparison between the criteria that 

19 NIOSH has set forth in this OCAS-IG-004 and 

20 the draft criteria that the Surrogate Work 

21 Group prepared.

22 And in many regards, they are very 
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1 similar. That is there is a lot of overlap 

2 between this document and the draft criteria 

3 by the Working Group.

4 There is one criterion that is in 

5 OCAS-IG-004 that is not in the criteria for 

6 the Work Group and that has to do with 

7 plausibility. And I know that everyone is 

8 aware of that issue.

9 And the other aspect that is an 

10 important difference between the Working Group 

11 is the issue of the -- I guess at the time --

12 the time period. The Work Group -- Surrogate 

13 Data Work Group had some very specific 

14 language that you really have to -- the data 

15 you are using as surrogate data has to come 

16 from the same time period that you are 

17 applying it to.

18 While NIOSH's criteria says that 

19 well, you know, it is desirable to do that but 

20 you certainly can use data from another time 

21 period to apply but, of course, you have to be 

22 very careful. And they lay out the 
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1 conditions under which, you know, perhaps, you 

2 know, you could do that.

3 So I would say to boil things 

4 down, those are the two areas where there is a 

5 -- I would say a substantive difference 

6 between the two documents.

7 I don't know, Hans, is there 

8 anything -- Hans, are you on the line?

9 DR. BEHLING: Yes, I am.

10 DR. MAURO: Yes, is there anything 

11 that you may want to add to that? And I just 

12 tried to capture the sense of your report.

13 DR. BEHLING: Yes. I would just 

14 like to say that the initial issue that you 

15 discussed was really a legal issue. And we 

16 were asked to refrain from further comment 

17 because I guess we were considered non-lawyer 

18 types and, therefore, perhaps not entitled.

19 But on the other hand, it seems in 

20 our write up we did ask the Board to look into 

21 it and specifically in context with Paragraph 

22 82.17. And I guess it really comes down to 
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1 the simple thing. When we talk about 

2 surrogate data, we cannot talk about a single 

3 type of surrogate data because what we are 

4 really talking about are degrees of separation 

5 for the various types of surrogate data.

6 And I guess the surrogate data 

7 that are being addressed in Implementation 

8 Guide 004 is really defined in footnote number 

9 three on page four of that particular document 

10 which basically provides you with the 

11 following.

12 It says in footnote three, 

13 traditionally the term surrogate data refers 

14 to the use of any data that is not a direct 

15 measure of the individual worker's exposure 

16 conditions, e.g., general air samples of 

17 coworker models. In this document, however, 

18 the surrogate data is only considered in the 

19 context of the use of data from another 

20 facility.

21 So here we are basically looking 

22 at a very unique definition of surrogate data 
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1 which says from another facility, which means 

2 separation in space and time. And, of course, 

3 that is probably the furthest of degree of 

4 separation in use of surrogate data.

5 For instance, if we were to say a 

6 person worked at Facility A and he was not 

7 monitored but we have coworkers who were 

8 monitored at the same facility during the same 

9 time period, we would say well, it is 

10 surrogate data but it is very close in time 

11 and space.

12 On the other hand, I think what we 

13 were questioning in our initial assessment of 

14 Implementation Guide 004 was this high degree 

15 of separation in time and space. And for that 

16 we referenced 82 CFR 17 and there is the 

17 definition that we were looking at or I was 

18 looking at was that there were three types of 

19 data that can be used.

20 But in two of the three types, the 

21 statement in the regulations state that the 

22 monitoring data taken from coworker data has 
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1 to be considered. In other words, we have to 

2 really look at the environment in which the 

3 individual for whom there is no direct 

4 monitoring data was actually exposed. And, of 

5 course, that is the question.

6 It's a highly subjective issue 

7 when you say okay, the surrogate data is not 

8 the facility in which he worked both in 

9 location and in time. And to what extent do 

10 the current regulations support the use of 

11 such data? And I think this is something that 

12 the Board has yet to really discuss.

13 CHAIRMAN MELIUS: Anything 

14 further, John?

15 DR. MAURO: I just -- yes, one of 

16 the things that we neglected to point out, 

17 we're defining surrogate data -- I presume 

18 everyone agrees -- as using data from one site 

19 for another site. And it has become a term of 

20 trade amongst ourselves.

21 Whenever we're talking about data 

22 on a given site for the same site, that goes 
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1 toward the building of a coworker model. So I 

2 guess it is important that everyone recognize 

3 -- I assume everyone was familiar with -- when 

4 we refer to surrogate data, we're referring to 

5 data collected from one site and them somehow 

6 applying it to workers at another site. We 

7 want to keep that in mind.

8 CHAIRMAN MELIUS: Okay. Anything 

9 further?

10 MEMBER MUNN: Yes, with respect to 

11 this particular group of items, Jim, I'm sure 

12 that you are aware that we have looked at all 

13 of these findings in the Procedures Work 

14 Group. And the decision was made to transfer 

15 the two outstanding items, which is Item 3 and 

16 Item 7 from Procedures to you.

17 You have not yet received that 

18 email from me with that information. But I --

19 it was the expectation of Procedures that 

20 those two items would be transferred to this 

21 Work Group for a solution.

22 CHAIRMAN MELIUS: Wanda, are you 
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1 saying the check is in the mail?

2 MEMBER MUNN: The check is in the 

3 mail. It's on my list of Work Group items to 

4 be completed.

5 CHAIRMAN MELIUS: I understand.

6 MEMBER MUNN: It's on my action 

7 list, my personal action list.

8 CHAIRMAN MELIUS: Which is one of 

9 the reasons I wanted to focus on this document 

10 because I think it is probably the most -- the 

11 one we've all reviewed and there is written 

12 comments on. And I believe the specific areas 

13 are the ones that we would be focusing on 

14 anyway.

15 But there is one other issue I 

16 guess to go back to which I find sort of 

17 puzzling. And this is a question for NIOSH. 

18 It came up -- the NIOSH surrogate data 

19 document, the document that SC&A is reviewing, 

20 you present sort of a -- what I originally 

21 took to be sort of a scientific justification 

22 for using surrogate data by referencing other 
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1 situations where surrogate data is used, 

2 either other programs or epidemiological 

3 studies or models in the area.

4 But in your response to the SC&A 

5 critique of those, sort of NIOSH seems to walk 

6 away from that. And I guess I'm having 

7 trouble understanding your response on that.

8 DR. NETON: This is Jim Neton. I 

9 think SC&A's observation was correct in the 

10 sense that the -- some of the examples that we 

11 offered as precedents for the use of surrogate 

12 data are not directly applicable to a 

13 compensation program. And, in fact, this is a 

14 fairly unique compensation program.

15 As I indicated -- as we indicate 

16 in our response, we are merely trying to point 

17 out that, you know, we did not sort of invent 

18 this technique. Surrogate data has been used 

19 scientifically in a number of different 

20 applications, including epidemiologic studies 

21 but also I think we reference one previous 

22 compensation program.
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1 Even in that case, however, one 

2 can argue that, you know, it was a different 

3 type of compensation program and methodology 

4 and such.

5 So the point really wasn't that it 

6 justified the use of surrogate data under 

7 EEOICPA but the fact that it is a valid 

8 scientific technique that can be used when you 

9 have to fill in, as the law requires, for 

10 missing data. By that definition, any missing 

11 data is surrogate data. And we've developed 

12 techniques and one of which is to use data 

13 from one facility to another.

14 So I'm not saying -- I don't know 

15 as we necessarily backed away from it but we 

16 definitely didn't want to leave the 

17 misconception that SC&A seemed to have that we 

18 offered that as positive proof that it was

19 valid for use under EEOICPA. I'm not sure I 

20 have much more to say.

21 CHAIRMAN MELIUS: No, no, that's 

22 putting it well. That's like -- I thought you 
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1 were saying and it wasn't in your response --

2 the SC&A review of IG-004. However, it has 

3 not been sort of what, I think, has been 

4 presented verbally at least at a number of our 

5 previous discussions of this issue.

6 And so I was just, I guess, 

7 wanting to reaffirm that because I mean I 

8 actually agree with SC&A and I guess with 

9 NIOSH that these other uses are significantly 

10 different. And, for example, the use of 

11 surrogate data for epidemiological studies is 

12 sort of far different than using surrogate 

13 data for individual dose reconstruction.

14 In fact, one would expect a higher 

15 degree of accuracy or precision in using it 

16 for individual dose reconstructions than one 

17 would for using it in epidemiological data 

18 where in a sense you are looking at big groups 

19 of people and trying to categorize them in 

20 some way.

21 And albeit more accurate to do 

22 that, the better, but it still -- you're not 
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1 trying to predict what an individual's dose 

2 was.

3 DR. NETON: I agree with you on 

4 that point except for the fact that in this 

5 program, we do have the opportunity to produce 

6 what we would believe to be a plausible upper 

7 bound so that they are not necessarily exact 

8 representations of the person's dose. We're 

9 not constrained to that.

10 We can demonstrate that as a 

11 plausible upper bound, we believe that it is a 

12 significantly accurate technique.

13 MEMBER LOCKEY: This is Jim 

14 Lockey. In some of the studies that we do 

15 here at the university, and they are 

16 epidemiology studies, we actually will go back 

17 where the data is good data, we'll use 

18 surrogate data where we can actually come up 

19 with a worker-specific cumulative exposure 

20 based on -- and, again, it's really based on 

21 how good the data is from the company we're 

22 looking at or the industry we're looking at 
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1 and productivity changes and equipment changes 

2 and ventilation changes. And how you can 

3 apply it across industries.

4 But it is a scientific methodology 

5 that is accepted if you have good quality data 

6 and you can really keep a log as to your 

7 justification as to why it is applicable to 

8 another industry across the street that is 

9 essentially doing the same job.

10 And so I would say there is 

11 literature out there that says -- and, again, 

12 it is based on the quality of the data and how 

13 high you set your confidence intervals on that 

14 data -- but there is literature out there that 

15 supports using surrogate data from an 

16 epidemiology perspective, looking at dose 

17 response relationship, particularly your dose, 

18 not duration, not job task, but true dose.

19 DR. MAKHIJANI: This is Arjun. 

20 Just the difference between what the two Jims 

21 said. You would not put an upper bound dose 

22 in an epi study because it would distort it.
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1 CHAIRMAN MELIUS: I'm sorry. I 

2 can't hear you.

3 DR. MAKHIJANI: This is Arjun.

4 CHAIRMAN MELIUS: Yes?

5 DR. MAKHIJANI: You would not put 

6 an upper bound dose in an epi study because it 

7 would distort your dose response relationship. 

8 But in this program, you sometimes want to 

9 put an upper bound.

10 CHAIRMAN MELIUS: Well, what we do 

11 is we can put a -- we can say this is what we 

12 think the mean is and this is what the upper 

13 bounds can be based on how good or not good 

14 the quality of the data is.

15 So you present it all so the 

16 reader can read it all. But you can do that 

17 like, you know, for refractory summary fibers, 

18 which we've been looking at for 20 years.

19 We can actually go back and 

20 extrapolate what the most likely individual 

21 dose is in another company who made that 

22 material based on the time frame they were 
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1 producing it, the machine that they were 

2 using, the ventilation equipment they were 

3 using, and their particular job tasks.

4 So we can assign an individual 

5 dose to that worker even though we don't have 

6 industrial hygiene data.

7 MEMBER LOCKEY: And, Jim, I think 

8 really it depends on the quality of the data 

9 and how much of the information you have 

10 available. If you don't have the production 

11 data, you don't have the machinery, you don't 

12 have the ventilation data, you don't have the 

13 source material, et cetera, et cetera, it 

14 becomes much more difficult.

15 CHAIRMAN MELIUS: I think we have 

16 two conversations going on here, Jim. But I 

17 heard most of what you said on that.

18 DR. BEHLING: Dr. Melius? Let me 

19 just make a comment since I was the one who 

20 wrote most of the stuff that you are referring 

21 to here.

22 I didn't say that epidemiologic 
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1 data would suffer from very accurate data. 

2 What I intended to say here is that accurate 

3 data, while it is most important if you do 

4 have a dose response relationship that you 

5 need to define.

6 On the other hand, many 

7 epidemiology studies can survive in the 

8 absence of dose-particular, highly detailed 

9 information and still provide the 

10 epidemiologist with a tool to say that there 

11 is a positive correlation even if the 

12 individual numbers are far from accurate.

13 And in the case of the 

14 compensation program, we do look for accuracy. 

15 And for that reason, we do have -- if there 

16 is an absence of data, the SEC option. And 

17 this is the point that I was trying to make 

18 here. I didn't want to imply that, as Dr. 

19 Lockey said, when there is good data 

20 available, of course you use it.

21 But there are plenty of 

22 epidemiology studies that are not necessarily 
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1 in a position to make use of those highly 

2 definitive information, including some of the 

3 earlier BEIR studies that defined the dose 

4 relationship between Hiroshima and Nagasaki 

5 survivors to that of cancer induction.

6 And that was the whole point of my 

7 statement here is that an epidemiologic study, 

8 unlike the compensation program, may survive 

9 in the absence of definitive data. But in the 

10 case of a compensation program that looks at a 

11 50 percent probability causation as a cut-off 

12 point, then I think you have to be a little 

13 more discriminating as to what is acceptable 

14 and what is not acceptable. And that's the 

15 point of that discussion.

16 MEMBER LOCKEY: Hans, I agree with 

17 your statement. I just think there are 

18 studies -- there are epi studies available 

19 that do precisely that. That can come up with 

20 a very precise individual dosimetry on person.

21 DR. BEHLING: Absolutely. And I 

22 fully agree. And as I said, that's not the 
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1 point of what I stated here.

2 When that data is available, of 

3 course you would make use of it. There's no 

4 question that there are some epidemiologic 

5 studies that have as a basis in terms of 

6 defining a dose response relationship, first 

7 class data. On the other hand, there may be 

8 many epidemiologic studies whose data would 

9 not suffice to do a compensation program. And 

10 that's the point of my discussion.

11 MEMBER LOCKEY: No, I don't 

12 disagree. I think your write-up though didn't 

13 give fair to the former, that there are --

14 actually there are some studies out there that 

15 do have very precise dose response 

16 relationships on a worker by worker basis.

17 MEMBER ZIEMER: This is Ziemer. I 

18 would just comment that I think we're only 

19 talking here about the principle that if data 

20 is used in scientific applications, not just 

21 epidemiology, but multiple, you always have to 

22 show that it applies in the case that you are 
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1 using it for. So --

2 DR. BEHLING: Absolutely.

3 MEMBER ZIEMER: -- that's what I 

4 think leads you to the criteria which, you 

5 know, we will get to I suppose and at some 

6 point we need to formalize. But what it leads 

7 you to is the criteria which you can operate 

8 and say this is a valid use or not.

9 I don't think anybody is arguing 

10 that we're using this for epidemiological 

11 studies. I think the question Hans is raising 

12 is can you use this sort of methodology in a 

13 different application.

14 I think the general statement, as 

15 I understood it in the NIOSH document, was 

16 simply that the principle of using surrogate 

17 data is one that cuts across a number of 

18 scientific disciplines. It's not a new method 

19 by focus but it is used in a variety of 

20 different scientific applications in 

21 appropriate ways. So that's just a comment.

22 CHAIRMAN MELIUS: Yes, this is Jim 
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1 Melius. But I think the way it has been 

2 discussed, though it is not, I don't think, 

3 written in this document, but discussed in the 

4 past is that sort of the use of surrogate data 

5 in epidemiological studies therefore means 

6 that it has sufficient accuracy to be used in 

7 dose reconstruction.

8 And I think that doesn't 

9 necessarily follow. And I think that is sort 

10 of what we had heard before. And similarly 

11 the use of surrogate data in individual 

12 exposure protection means that it is 

13 sufficiently accurate. And I think that that 

14 also, you know, doesn't necessarily follow.

15 And as we continue to go through 

16 this program over the years, what we continue 

17 to wrestle with what is sufficient accuracy 

18 and also what is plausibility. And I'm afraid 

19 that is what this issue also tends to come 

20 down to. And I guess we will continue to 

21 wrestle with those.

22 And I guess we don't -- we can't 
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1 rely on outside uses of surrogate data or 

2 anything else, the applications as a way 

3 around having to wrestle ourselves with what 

4 is sufficient accuracy and what is 

5 plausibility.

6 Anybody else have any comments on 

7 that?

8 (No response.)

9 CHAIRMAN MELIUS: Okay. In the 

10 interest of the third -- if you are referring 

11 to the Executive Summary that -- SC&A's report 

12 which starts on page four and goes through --

13 number one is the legal issue -- regulatory 

14 issue. I'm not going to -- I'm going to 

15 ignore that.

16 Secondly was the precedent, the 

17 discussion we just had.

18 The third issue that is raised is 

19 the issue of -- which I think NIOSH agrees 

20 with, if I understand correctly, that 

21 basically -- and what John stated earlier --

22 is that the -- that while the criteria that 
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1 are laid out in 004 may be sound, I mean the 

2 real issue is the application. And if I 

3 understand NIOSH's response to the SC&A 

4 comments is basically NIOSH agrees. It's sort 

5 of a question of application.

6 DR. NETON: Yes, that's right. I 

7 mean we don't disagree that there may be some 

8 difficulties in countering the application of 

9 the data -- or surrogate data. But, you know, 

10 the proof is in the -- we believe that it is 

11 incumbent upon us when we do use it to 

12 demonstrate through the application of these 

13 tests that they are, indeed, scientifically 

14 sound. So it will be -- the proof is in the 

15 pudding, I guess.

16 CHAIRMAN MELIUS: I think we've 

17 been using biscuit analogies.

18 DR. NETON: Okay.

19 CHAIRMAN MELIUS: The proof is in 

20 the biscuit dough.

21 DR. NETON: Yes. And there may be 

22 some applications where, you know, we run up 
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1 against the wall and say yes, we can't use it 

2 in this particular situation. That remains to 

3 be seen.

4 CHAIRMAN MELIUS: Well, I think 

5 Blockson is an example, right?

6 DR. NETON: Well, Blockson, I was

7 going to mention that previously -- well, 

8 there's two issues with Blockson.

9 One is the radon issue, which I 

10 don't really believe is a Type 1 surrogate 

11 data application. That is a model, a 

12 probabilistic model that was based on 

13 essentially first principles of air turnovers 

14 and such. So it did not -- I'm speaking of 

15 the second generation radon level.

16 CHAIRMAN MELIUS: Oh, okay. I was 

17 talking about the first generation.

18 DR. NETON: The first generation 

19 model, I would agree --

20 CHAIRMAN MELIUS: Yes, okay.

21 DR. NETON: -- withdrew that 

22 because it didn't pass the test in our paper.
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1 CHAIRMAN MELIUS: Yes.

2 DR. NETON: Okay, if we're talking 

3 about the first model, I would agree with you.

4 CHAIRMAN MELIUS: Yes, okay.

5 DR. NETON: At least for that 

6 particular facility.

7 CHAIRMAN MELIUS: Yes.

8 MEMBER ZIEMER: Dr. Melius?

9 CHAIRMAN MELIUS: Yes?

10 MEMBER ZIEMER: Ziemer here. 

11 We're still on the third item in the --

12 CHAIRMAN MELIUS: Yes, we are.

13 MEMBER ZIEMER: Yes, it looked to 

14 me like -- is the focus on this the time 

15 period issue? Or maybe I should ask SC&A 

16 that. It basically ends saying such use would 

17 be in conflict with the draft criteria, which 

18 restricts the use of surrogate data to the 

19 same time period.

20 DR. MAURO: This is John. To 

21 answer your question, it's both. Item number 

22 three is a broad sweep. It identifies the 
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1 different parameters that you have to be 

2 careful about when you are applying surrogate 

3 data. And it talks about lots of things.

4 MEMBER ZIEMER: Yes.

5 DR. MAURO: But one -- and we 

6 brought up in this particular finding under 

7 number three specifically, that we do have a 

8 difference between the draft Work Group 

9 criteria and the OCAS-004.

10 MEMBER ZIEMER: Yes.

11 DR. MAURO: That has to do with 

12 time. So yes, I think we do have an issue 

13 here that needs to be dealt with.

14 MEMBER ZIEMER: Yes.

15 DR. MAURO: That is right now I 

16 think that, you know, the NIOSH position is 

17 notwithstanding the fact that they may be from 

18 different time periods, you still can use it 

19 if you are careful.

20 MEMBER ZIEMER: Yes. Well, my 

21 comment on that was -- and I had a comment in 

22 the draft comments that we made -- I'm getting 
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1 a lot of noise here. Is that just my phone?

2 CHAIRMAN MELIUS: No.

3 MEMBER ZIEMER: In any event, 

4 about a year ago, I forget the exact date, I 

5 made some comments which were distributed to 

6 the Work Group on our draft. And on that 

7 particular one, I made a note that said we 

8 need it to be clarified the meaning of the 

9 same general time period in terms of what that 

10 means.

11 Now the time period might be the 

12 time where the technology is the same or 

13 different, where the legal requirements are 

14 the same or different, the work practices were 

15 the same or different. A time period might be 

16 less than a year or it might be a decade, 

17 depending on what the particular parameters 

18 are.

19 So it seems to me that in any 

20 event under temporal, we would have to clarify 

21 -- and I think the intent here on time period 

22 is that you have to compare situations where 
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1 the working conditions and processes and 

2 monitoring methods were the same or similar. 

3 And, in some cases, even the legal 

4 requirements because people are working where 

5 there are different dose constraints.

6 But -- so what is the intent, I 

7 think, of the time period issue, as I would 

8 understand it, is that you can't compare a 

9 period where there are completely different 

10 work practices, safety measures, and all of 

11 those things, and make a valid case for using 

12 that as surrogate data.

13 CHAIRMAN MELIUS: Any comments on 

14 that? I think that would be the intent. I 

15 actually have your document in front of me, 

16 Dr. Ziemer, your comments on the document.

17 DR. MAKHIJANI: Jim, this is 

18 Arjun.

19 CHAIRMAN MELIUS: Yes?

20 DR. MAKHIJANI: Sorry.

21 MEMBER ZIEMER: Yes. And at some 

22 point, I even have some wording to propose for 
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1 that. But that will come at an appropriate 

2 time.

3 CHAIRMAN MELIUS: Okay.

4 DR. MAKHIJANI: Jim, this is 

5 Arjun. One of the things to consider is, you 

6 know, as John was saying, the surrogate data 

7 we're seeing as applied from one -- data taken 

8 from one site and applied to another site.

9 But we have also considered this 

10 an issue of data within a site, you know, when 

11 you take data from one period and try to apply 

12 it to another period. This has turned out to 

13 be a problem type of, you know, use of data, 

14 even within the site. And we're not calling 

15 it surrogate data but I think to some extent, 

16 at least, it is the same issue.

17 DR. MAURO: That is exactly what 

18 happened at Blockson where there were radon 

19 measurements collected in the `80s and we all 

20 agreed that listen -- well, I don't know if we 

21 all agreed but there was a general consensus 

22 that it is very difficult to use the radon 
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1 data measured in the 1980s to dose 

2 reconstructions that occurred before the 

3 1950s. So that's, I would say, a good 

4 example.

5 DR. NETON: This is Jim. I would 

6 agree with what has been said.

7 But I would also go back to what 

8 Dr. Ziemer suggested which is the intent 

9 really is the similarity of operations. And I 

10 think to just make a blanket statement that it 

11 has to be exactly the same time period is 

12 problematic for us.

13 I mean there are situations where 

14 forward in time might be more appropriate 

15 where they use exactly the same grinding 

16 machine for 15 years and the example I can 

17 think of is the grinding operation and there 

18 were process samples taken that were right 

19 there at the generation of the aerosol at the 

20 same machine. 

21 It really doesn't make a lot of 

22 difference about the general area patterns of 
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1 air ventilation and such under those unique 

2 situations what we would be able to take 

3 advantage of. That's somewhat what I had in 

4 mind here when we drafted that section.

5 CHAIRMAN MELIUS: Any other 

6 comments on that?

7 DR. MAKHIJANI: Well, Jim, the 

8 only other comment I would have is, you know, 

9 in partial agreement with what Jim Neton just 

10 said, is that data from one building to 

11 another building or one facility to another 

12 facility within the same site has also been 

13 the same kind of issue.

14 So I think broadly yes, the 

15 environmental and dosimetric comparison needs 

16 to be established. And I think how that is to 

17 be elaborated is kind of complicated.

18 CHAIRMAN MELIUS: Yes, no, I agree 

19 with you Arjun that we're looking at -- we 

20 focused on sort of one specific type of 

21 surrogate data or data that is being, you 

22 know, where we're either extrapolating time 
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1 periods or locations. And this is, you know, 

2 where we're taking something outside of an 

3 area but outside of the facility.

4 But that is sort of an artificial 

5 distinction. And the same kinds of 

6 considerations would apply to the area that

7 you mentioned, really the two, one building to 

8 another, one part of a facility to another, or 

9 one time period to another.

10 And we have often found those 

11 kinds of application of information to be 

12 problematic for some of the same reasons that 

13 are set out in either the NIOSH criteria or 

14 the staff criteria that the Work Group had 

15 originally developed.

16 MEMBER MUNN: This is Wanda. 

17 There are commonsense considerations that 

18 certainly override any of our concerns with 

19 respect to definitions of terms, especially 

20 with respect to bounding issues. If one knows 

21 that only a certain type of material is 

22 handled and it is handled consistently and it 
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1 is handled over a long period of time, common 

2 sense tells us that the highest measurements 

3 that one gets, no matter what period of time 

4 is involved, is the highest measurement one 

5 gets.

6 And it -- to lean upon a statement 

7 that is involved in a general definition as 

8 being a reason to disregard good basic 

9 information that you have is not a reasonable 

10 thing to do. And we have had considerable 

11 discussion about reasonableness and 

12 plausibility.

13 CHAIRMAN MELIUS: Yes, I don't 

14 disagree with some of that. But we also don't 

15 have certainly criteria for plausibility. 

16 It's something that when we get into 

17 difficulty, we disagree on and wrestle with. 

18 And similarly with sufficient accuracy.

19 And I think that as a general 

20 statement of either moving from one facility 

21 to another or moving from one time period to 

22 another, the farther one gets, the more 
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1 differences that are unknown because of the 

2 lack of documentation, you know, different 

3 parts of the site or time periods of the site, 

4 or because of limitations on monitoring 

5 methods in the past and so forth, so I think 

6 we've run across a lot of situations where we 

7 just don't know enough about it.

8 So not having sufficient, you 

9 know, a building or operation or other factors 

10 like that, make the extrapolation or use of 

11 surrogate data more difficult.

12 MEMBER ZIEMER: Jim, this is 

13 Ziemer. I agree with that. And I think it 

14 would be helpful at some point, and I know you 

15 intend to do this, would be to actually deal 

16 with the plausibility issue. I think we can 

17 discuss it as we have some of the other 

18 parameters.

19 And say what does it mean for 

20 something to be plausible. And what are, you 

21 know, at what -- we can't necessarily define 

22 when something becomes implausible. But we 
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1 could at least put some parameters down or 

2 some approaches to how you establish 

3 plausibility.

4 And it seems to me you can talk 

5 about plausibility in terms of workplace, for 

6 example how well do things match up or maybe 

7 the grinding machine, you got workplace 

8 plausibility issues.

9 I think you have scientific 

10 plausibility issues with regard to like 

11 bioassay models, radon models, those kinds of 

12 things. There are different kinds of 

13 plausibility that would have to come together 

14 in a way that would give people confidence in 

15 use of surrogate data.

16 Or if it doesn't come together, 

17 you don't do it. But it seems to me we do 

18 need to grapple a bit with what constitutes or 

19 how we would go about establishing 

20 plausibility.

21 MR. KATZ: I'm sorry to interrupt. 

22 This is Ted.
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1 Jim, let me just make another 

2 attempt. Maybe there are some people on the 

3 phone who were not on the front end of the 

4 call. Everybody on the call who is not 

5 participating, please mute your phones. It is 

6 very hard to hear with all the background 

7 noise.

8 And even if you don't have a mute 

9 button, there is a * and a 6. You can press 

10 *6 together and that will mute your phone and 

11 make it much easier for the participants to 

12 hear each other as well as the court reporter 

13 who has to transcribe all of this. Thank you.

14 MEMBER LOCKEY: Paul, Jim Lockey. 

15 Were you talking about their plausibility in 

16 relationship to how two work sites meet 

17 criteria that is plausible that they were

18 similar? Is that what you were referring to?

19 MEMBER ZIEMER: What I was 

20 referring to?

21 MEMBER LOCKEY: Yes. Are you 

22 talking about work site plausibility?
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1 MEMBER ZIEMER: Well, I was 

2 talking about the overall concept of 

3 plausibility as some component. One is how 

4 well the workplaces compare. Another is the 

5 scientific parts. I mean --

6 MEMBER LOCKEY: But in 

7 relationship to --

8 MEMBER ZIEMER: -- you have to use 

9 models that are scientifically plausible --

10 MEMBER LOCKEY: Right.

11 MEMBER ZIEMER: -- as well as --

12 and we've had these kinds of discussions in 

13 other venues for other Work Groups where we 

14 talk about what is scientifically plausible in 

15 certain cases. But I was thinking in terms of 

16 our criteria document, that we need some 

17 discussion on how one goes about establishing 

18 plausibility.

19 It is more than a gut feeling. I 

20 think --

21 MEMBER LOCKEY: I think so, too. 

22 I think -- but I hear you talk about workplace 
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1 situations where it is plausible that Work 

2 Site A is similar to Work Site B even though 

3 ten years separate them in time.

4 MEMBER ZIEMER: Well, I don't even 

5 know at this point, I'm just thinking 

6 conceptually that if it is not plausible that 

7 the workplace in question is well represented 

8 by some other workplace who is the surrogate, 

9 then, you know, how do you decide that?

10 MEMBER LOCKEY: Yes. I think -- I 

11 agree with both of you, I think there should 

12 be work site plausibility criteria. You know 

13 why are they similar? It's based on these 

14 following blah things.

15 MEMBER ZIEMER: Or if they are 

16 not, what would allow the data to be used.

17 MEMBER LOCKEY: That's correct. I 

18 agree.

19 MEMBER ZIEMER: And there may be -

20 - I just thought of workplace and scientific, 

21 both of those things. There may be some other 

22 issues but --
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1 MEMBER LOCKEY: Yes.

2 MEMBER ZIEMER: I mean by 

3 workplace, I'm talking not only about the 

4 physical facilities but the working 

5 procedures, maybe even the types of personnel 

6 present and probably even some legal issues in 

7 terms of what safety processes were mandated 

8 or required under certain time periods and so 

9 on.

10 MEMBER LOCKEY: No, I think that's 

11 a good point. And I agree with that. And 

12 that's what we do when we do dose 

13 reconstructions.

14 DR. MAURO: Yes, Paul, this is 

15 John. I often, when I'm looking at these dose 

16 reconstructions and the construction of 

17 coworker models and, of course, the use of 

18 surrogate data and the issue of plausibility 

19 emerges in my mind. It usually is not the 

20 issue of plausibility. It's implausibility.

21 MEMBER ZIEMER: All right. Well, 

22 and that may be a good way to look at it.
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1 DR. MAURO: Yes, because -- yes, I 

2 have another example. You know in addition 

3 to, for example, if you are about to use a 

4 model or use data from one site to another, or 

5 make certain assumptions from one location in 

6 the building to another location in the 

7 building, I very often ask myself well, we 

8 find ourselves often in a situation where the 

9 exposures that you are going to assign to an 

10 individual in your coworker model are of such 

11 a nature that very often I'll say that doesn't 

12 sound plausible.

13 And the reason I would say -- that 

14 comes to mind often is if that were to occur -

15 - well, an example would be the person 

16 couldn't stay in the room and continue to 

17 breathe the air. Or --

18 MEMBER ZIEMER: Yes.

19 DR. MAURO: -- the dose the person 

20 would experience would result in acute 

21 radiation syndrome, you know local damage to 

22 the respiratory tract.
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1 In other words, though, very often 

2 the test I put it to, in addition to the types 

3 that you have been discussing by way of 

4 facility operations, it is not within the 

5 range of what would have been the operating 

6 parameters of a given facility, I also 

7 sometimes think in terms of just -- almost 

8 like biological endpoints.

9 They've got a person actually 

10 working in an environment like that without 

11 there being some record of there being some 

12 acute radiation effects at such levels. I've 

13 run into circumstances where we find ourselves 

14 in that realm. And then I start to ask myself 

15 plausibility questions.

16 DR. NETON: Jim, that's exactly 

17 Section 3.6 says in the IG-004.

18 CHAIRMAN MELIUS: Yes, I was going 

19 to point that out. It's on the bottom of page 

20 eight into page nine on that. But I mean I 

21 guess I find that sort of lacking -- not to 

22 fault NIOSH but it sort of addresses the 
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1 obvious issues. It doesn't address -- I think 

2 a lot of times we're tying plausibility to 

3 sufficient accuracy. And so the question may 

4 be -- and I think in other factors. And I 

5 think it would behoove us to I think give more 

6 thought to what we mean by plausibility and 

7 how we would consider it separate from these 

8 other factors.

9 At first I was resistant to adding 

10 it as a criteria because I think it is hard to 

11 define. And secondly, to some extent, it is 

12 taken care of by the other criteria. It may 

13 be an overriding factor that, you know, would 

14 override. Yes, you're not going to come up 

15 with something that is so high that, you know, 

16 people wouldn't be able to breathe or 

17 whatever.

18 But I think that usually the 

19 situation we're having trouble with, it is 

20 more complicated than that. But it is hard to 

21 get at aside from an example. But we continue 

22 to wrestle with it in lots of different 
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1 situations as we're doing now with the 

2 Blockson model, too.

3 MEMBER ZIEMER: Jim, this is 

4 Ziemer. I think you may be right that in a 

5 sense, you handle the first four criteria, 

6 that kind of overall kind of deals with 

7 plausibility issues perhaps although I'm not 

8 sure that we have dealt with -- specifically 

9 with scientific plausibility in those. Maybe 

10 indirectly we have.

11 CHAIRMAN MELIUS: Yes, as I say, 

12 in some ways it is overriding. It is one of 

13 the factors you are considering when you deal 

14 with temporal situations.

15 MEMBER ZIEMER: Yes, right. You 

16 would say it is not plausible because 

17 temporally this has occurred.

18 CHAIRMAN MELIUS: Yes.

19 MEMBER ZIEMER: Or it is not 

20 plausible because these processes are under 

21 Criteria Two, the slider processes are 

22 sufficiently similar or something like that.
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1 CHAIRMAN MELIUS: Yes.

2 MEMBER ZIEMER: Yes. So maybe it 

3 gets inherently covered in the other criteria.

4 CHAIRMAN MELIUS: Yes, I mean I 

5 think if you sort of take the absurd example 

6 that we had a facility we knew nothing about. 

7 You know it was a unique operation, a unique 

8 type of exposure. I don't think we would 

9 consider it plausible for NIOSH to just sort 

10 of pluck the number out of the air and say 

11 that's the upper bound.

12 DR. NETON: Yes, this is Jim. I 

13 think the idea here was that when we do these 

14 -- when we apply surrogate data and port it 

15 from one facility to another, there are 

16 typically uncertainties involved. And more 

17 often than not, we would end up using the 95th 

18 percentile of some empirically-derived 

19 distribution from that other facility.

20 And the idea was that if the 

21 uncertainty was so great -- the GSD was so 

22 large that the 95th percentile got you into 
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1 one of those situations where, you know, it 

2 was just physically impossible to occur, then, 

3 you know, we certainly wouldn't want to use 

4 that. So I think it is sort of tied up in the 

5 uncertainty of the model more than anything.

6 CHAIRMAN MELIUS: Yes.

7 MEMBER MUNN: But that's no longer 

8 a plausibility issue. That's a possibility 

9 issue. When it continues reaching the 

10 impossible, then that is outside of 

11 plausibility.

12 DR. NETON: Right. And another --

13 the next paragraph under 3.6 I believe talks 

14 about a situation such as we had at I believe 

15 it was the Iowa Army Ammunition Plant where we 

16 had developed a model time period that was 

17 monitored for external that ended up being so 

18 large that when you compared it to the 

19 previous year, it was an order of magnitude 

20 higher. And it certainly didn't pass the 

21 plausibility test in that situation. So 

22 that's, again, what we had in mind in this 
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1 section.

2 DR. BEHLING: This is Hans 

3 Behling. I just want to make a comment 

4 regarding the issue of plausibility and using 

5 extreme high end numbers. And what I'm 

6 looking at here is under the regulation 

7 paragraph 82.10(k). There is obviously a 

8 limitation when you use such extreme numbers 

9 because under the regulations, those values 

10 can never be compensated.

11 And I can read you the specific 

12 section where it talks about worst case 

13 assumptions can never be used to compensate a 

14 claim but only to deny a claim if the PoC 

15 under the worst case assumption still doesn't 

16 match the 50th percentile value. So --

17 DR. NETON: Well, I think that is 

18 a slight misinterpretation of that section. 

19 That section was for worst case assumptions 

20 without conducting additional research.

21 In other words, NIOSH would have 

22 stopped short their research and used a worst 
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1 case assumption and decided that the case was 

2 still under 50 percent. You can't use that to 

3 start compensating people. I would agree with 

4 that.

5 But if, at the end of the day, all 

6 your worst case assumptions end up being your 

7 best estimate and it is plausible, I would 

8 suggest that it could be used.

9 DR. BEHLING: Okay. It is a very 

10 fine definition and I just wanted to bring 

11 that up because sometimes we tend to get 

12 reckless in assigning a worst case assumption, 

13 realizing however that it is still going to 

14 end up with a PoC of less than 50 percent 

15 when, in fact, if we were to realize that it 

16 was greater than 50 percent under those 

17 conditions, we would be in violation of the 

18 regulations.

19 DR. NETON: Right. I agree. And 

20 I think there was one episode in the past 

21 where that occurred. But I think that was an 

22 isolated incident. And that's the only one 
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1 that I can think of.

2 CHAIRMAN MELIUS: What was that? 

3 What was that -- this is Jim Melius -- that 

4 determined?

5 DR. NETON: Well, I think at one 

6 point, there were a few dose reconstructions 

7 where we actually -- they ended up going out 

8 the door using worst case assumptions.

9 CHAIRMAN MELIUS: Oh, okay.

10 DR. NETON: And, you know, we 

11 certainly reversed our thinking on that.

12 CHAIRMAN MELIUS: Yes, okay.

13 DR. NETON: And to my knowledge, 

14 nothing like that has been done since.

15 CHAIRMAN MELIUS: Okay, no, I 

16 recall that. I was trying to think if it was 

17 something I missed.

18 DR. MAURO: Interestingly enough -

19 - this is John -- when we encountered those 

20 circumstances, it was during our dose 

21 reconstructions audits where a bounding 

22 assumption that was written up into a 
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1 procedure was developed mainly for the purpose 

2 of efficiency -- oh, let's just assign this --

3 which, of course, is, you know, off-the-charts 

4 conservative, and it was still not 

5 compensating.

6 But we really never encountered 

7 this situation when we were reviewing in an 

8 SEC or site profile perspective when, for 

9 example, let's say NIOSH was building a 

10 coworker model and they were collecting data 

11 and making running models and making 

12 assumptions in order to build a coworker 

13 model.

14 In the end, that's what we're 

15 talking about, whether we're using a site16 specific data to build the coworker model or 

17 data from one site to apply to another site. 

18 Ultimately, what we're talking about is 

19 building a coworker model. And we're talking 

20 about that aspect of building a coworker model 

21 where NIOSH may need to draw upon data from 

22 another site.
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1 And within that, we are talking 

2 about, you know, at what point does the data 

3 from one site, as applied to another site, 

4 become implausible? In other words, just not 

5 plausible -- it could not apply to that site? 

6 And, therefore, you wouldn't need the 

7 plausibility.

8 And it is almost just like you 

9 would know it when you see it. But to talk 

10 about it in generalities, is difficult to say 

11 when would we be at a point that, you know, 

12 you really can't use that data, that 

13 situation. It just wouldn't make sense.

14 But it is so hard to define that. 

15 I mean there may be a way to explain it. It 

16 sounds like there is some language in the 

17 write up. I don't have your write up near 

18 but, Jim, so you have some language that sort 

19 of set the framework of plausibility? I just 

20 don't have it in front of me.

21 DR. NETON: Are you talking to me, 

22 John?
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1 DR. MAURO: Yes. I guess --

2 DR. NETON: Yes, there is a very 

3 brief section 3.6 in IG-004 that tries to set 

4 the stage plausibility although Dr. Melius is 

5 right, it's short on specifics although it is 

6 that way by nature because we couldn't come up 

7 with some very specific guidance other than 

8 these generalized tests.

9 We're certainly open to hearing 

10 suggestions as to how to make that better.

11 CHAIRMAN MELIUS: Somehow a 

12 criteria of we'll know it when we see it, 

13 would be helpful to -- but you said it, not 

14 me, Jim.

15 Any other comments on that?

16 (No response.)

17 CHAIRMAN MELIUS: Any other 

18 comments in general on surrogate data?

19 (No response.)

20 CHAIRMAN MELIUS: Then I have a 

21 suggestion for how to move forward.

22 (No response.)
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1 CHAIRMAN MELIUS: No comments?

2 MEMBER MUNN: We're breathlessly 

3 waiting.

4 CHAIRMAN MELIUS: Oh, okay. I 

5 thought Dr. Ziemer had something he wanted to 

6 bring up. That's why --

7 MEMBER ZIEMER: Oh, well, no, I 

8 thought if we were going to discuss the 

9 criteria documents, I would propose some 

10 things. Otherwise not. I have some words on 

11 the temporal consideration thing for that 

12 document.

13 But if you'd like, I could just --

14 CHAIRMAN MELIUS: Oh, okay. Well, 

15 actually what I was going to propose was that 

16 -- to update the -- our criteria document and 

17 include a section on plausibility, and 

18 circulate that to the Work Group between now 

19 and our meeting in February. And then we 

20 would have a discussion at the Board meeting.

21 But I'd like to get input, 

22 particularly on plausibility beforehand as 
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1 well as anything else that people want to 

2 comment on.

3 MEMBER ZIEMER: Well, I'll be glad 

4 to share some words both on temporal and I had 

5 already, on my own document here at home, put 

6 in some words on plausibility. And I can 

7 provide that as a straw man so that --

8 CHAIRMAN MELIUS: Okay.

9 MEMBER ZIEMER: -- that can at 

10 least get some people thinking. I'd be glad 

11 to have these things shot down completely. We 

12 can grapple with them. We might decide on 

13 plausibility that the other four criteria 

14 inherently cover it if you meet those.

15 But I agree, Jim, I think it makes 

16 sense at least to grapple with it. There may 

17 be something that emerges that is sort of 

18 outside the other criteria that we would need 

19 to consider. I don't know at this point.

20 But I'll be glad to offer up some 

21 words to at least people think about. And I 

22 don't ascribe to them any level of 
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1 profoundness. But sometimes it helps to have 

2 something to take a shot at.

3 CHAIRMAN MELIUS: Yes. I think 

4 that the examples offered by NIOSH are part of 

5 plausibility so that they're -- but I think 

6 it's -- how we think beyond that is -- I mean 

7 and I'll try something independently then 

8 maybe merge it with what you write, Paul.

9 MEMBER ZIEMER: Yes. I think that 

10 would be good. And probably other Work Group 

11 members, too.

12 CHAIRMAN MELIUS: Yes. Do that.

13 MEMBER MUNN: Well, you would 

14 assume that this would be, if I understood you 

15 correctly, in addition to our current document 

16 with regard to what constitutes surrogate 

17 data?

18 CHAIRMAN MELIUS: It would be part 

19 of our current document, correct.

20 MEMBER MUNN: Right. Thank you.

21 CHAIRMAN MELIUS: This Work 

22 Group's current document. I guess the other 
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1 issue I have is sort of -- well, I think in 

2 terms of the Procedures Work Group, I think 

3 we're okay. I just don't know how this ties 

4 in with the TBD-6000 Work Group and where that 

5 Work Group is.

6 MEMBER ZIEMER: Well, two things 

7 on TBD-6000 Work Group, we're dealing with the 

8 main document. And then we're dealing with 

9 some of the appendices.

10 The big focus, of course, now is 

11 on the Appendix A, which is General Steel 

12 Industries. But then we have a couple of 

13 others that have emerged after our last 

14 meeting. So there are some other sites. One 

15 is a 6001 site. And there is another 6000 

16 site. So there are some site-specific things 

17 we're dealing with.

18 But I think it's either -- and, of 

19 course, I think that the Texas City case was 

20 more of a surrogate. General Steel 

21 Industries, we're dealing with GSI's own data 

22 and its usability and some related issues. 
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1 But I think Texas City came to the Surrogate 

2 Data Work Group because it is more clearly a 

3 surrogate data issue.

4 DR. MAURO: This is John. When we 

5 look at TBD-6000 without the appendices for a 

6 moment, one of the most important things we 

7 were doing is to make sure that the different

8 -- it is basically a look-up table for 

9 different types of work activities that a 

10 person may be engaged in. For example, at a 

11 metal-working facility.

12 And there is a range of airborne 

13 dust loadings of a grain. And the main thing 

14 we looked at are the categories that were 

15 created and the range of concentrations of the 

16 dust loadings assigned and default values. Do 

17 we believe that they represent or properly 

18 capture the range of operating experience that 

19 is out there? And there's lots and lots of 

20 experience.

21 So we really looked at it from the 

22 point of view of when you are saying that a 
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1 machinist working at a metal-working facility 

2 will be assigned this concentration 

3 distribution in terms of dpm per cubic meter 

4 dust loading let's say of uranium, is that 

5 distribution a good distribution? Does it 

6 reflect the real experience that has occurred 

7 in the past?

8 So we really, when we looked at 

9 it, we just looked at it from the point of 

10 view of did it capture everything. That's a 

11 very different question than whether you think 

12 it is appropriate to apply that distribution 

13 to a given case. So I think it is important 

14 to make a distinction between -- TBD-6000 is a 

15 document that, in a claimant-favorable way, 

16 captures the range of exposures people might 

17 have experienced doing different kinds of 

18 jobs.

19 And then the big question always 

20 is okay, given that you get to the point where 

21 you agree, yes, this is a very good 

22 representation of the range of exposures, then 
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1 it becomes a matter of okay, you know, under 

2 what circumstances can you use this and use it 

3 in a way that you feel is plausible and 

4 claimant favorable.

5 I have to say that our experience 

6 is that when TBD-6000 is used, they usually 

7 draw upon the categories that are, by far, the 

8 most claimant favorable. In other words, if 

9 you had a real site and you are trying to 

10 assign some dust loading, they would go into 

11 TBD-6000 and usually pick that case, that job 

12 category that is the worst one, not giving any 

13 other information.

14 So we have gone a long way, I 

15 believe, in coming to closure on a lot of TBD16 6000 issues. What is the issue that really is 

17 in play is okay, how do you apply it? And how 

18 do you know you are applying it in a claimant19 favorable and plausible manner? And I think 

20 we are yet to engage that issue.

21 MEMBER ZIEMER: John, this is 

22 Ziemer. I agree with what you said because 
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1 that is, in a sense, a generic document. And 

2 you still have to show in a specific case that 

3 the parameters in there are applicable in 

4 terms of, you know, is there something about a 

5 particular site, either in terms of process --

6 well, all of the things we talked about --

7 that would take it outside of those parameters 

8 or that somehow it wouldn't apply.

9 So I think in principle, we still 

10 need the surrogate data criteria if you want 

11 to say yes, we're using TBD-6000. But do we 

12 still have a facility that matches up?

13 DR. MAURO: Yes, in fact, more 

14 than ever.

15 MEMBER ZIEMER: It's got be done 

16 on a case-by-case basis. You always have to 

17 make the case that it applies.

18 DR. MAURO: Yes. I would argue 

19 that the surrogate data criteria that 

20 eventually emerge from the process we're in is 

21 going to be extremely helpful when we are 

22 confronted with the use of TBD-6000.
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1 MEMBER ZIEMER: Exactly.

2 DR. MAURO: Yes.

3 CHAIRMAN MELIUS: But I would just 

4 add that I think that is the plausibility 

5 issue that we wrestle with the most is that 

6 balance between -- so sufficient accuracy on 

7 one hand, claimant friendliness on the other, 

8 and then are what we're doing, you know, is it 

9 plausible? And I think it is where we need to 

10 have some -- or at least attempt to develop 

11 some criteria as to how to address that.

12 Any other comments?

13 (No response.)

14 CHAIRMAN MELIUS: I will -- today 

15 is Monday -- try to circulate something by the 

16 end of next week at the latest so that there 

17 is time for input from the Work Group.

18 MEMBER ZIEMER: Okay. So you want 

19 something this week probably?

20 CHAIRMAN MELIUS: Yes, this week, 

21 yes. Or early next week.

22 MEMBER ZIEMER: Good.
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1 MEMBER LOCKEY: Paul, are you 

2 going to send something out as a straw man? 

3 Is that what you are going to do?

4 CHAIRMAN MELIUS: Yes. So if 

5 people could get any comments to me by say 

6 Tuesday of next week, then I'll circulate 

7 something by Friday.

8 MEMBER ZIEMER: Okay. I'm just 

9 going to send my stuff to you, Dr. Melius.

10 CHAIRMAN MELIUS: Okay, yes.

11 MEMBER ZIEMER: Okay.

12 CHAIRMAN MELIUS: Great. Any 

13 other comments? Ted, do you have anything?

14 MR. KATZ: No, I don't. Thank 

15 you.

16 CHAIRMAN MELIUS: Okay. Good. 

17 Take care everybody.

18 (Whereupon, the above-entitled 

19 matter went off the record at 2:35 p.m.)

20

21

22