THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 


PUBLIC HEALTH SERVICE 


CENTERS FOR DISEASE CONTROL AND PREVENTION 


NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 


convenes the 


WORKING GROUP MEETING 


ADVISORY BOARD ON 


RADIATION AND WORKER HEALTH 


SURROGATE DATA
 

The verbatim transcript of the Working 


Group Meeting of the Advisory Board on Radiation and 


Worker Health held telephonically on Nov. 16, 2007. 


STEVEN RAY GREEN AND ASSOCIATES
 

NATIONALLY CERTIFIED COURT REPORTING 

404/733-6070 
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C O N T E N T S
 

Nov. 16, 2007 


WELCOME AND OPENING COMMENTS 


DR. CHRISTINE BRANCHE, DFO 


INTRODUCTION BY CHAIR 11 


SURROGATE DATA DRAFT REPORT OF SEPT. 12, 2007 15 


FUTURE PLANS 60 


COURT REPORTER’S CERTIFICATE 69 

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TRANSCRIPT LEGEND
 

The following transcript contains quoted material. Such 


material is reproduced as read or spoken. 


In the following transcript: a dash (--) indicates 


an unintentional or purposeful interruption of a 


sentence. An ellipsis (. . .) indicates halting speech 


or an unfinished sentence in dialogue or omission(s) of 


word(s) when reading written material. 


-- (sic) denotes an incorrect usage or pronunciation 


of a word which is transcribed in its original form as 


reported. 


-- (phonetically) indicates a phonetic spelling of 


the word if no confirmation of the correct spelling is 


available. 


-- "uh-huh" represents an affirmative response, and 


"uh-uh" represents a negative response. 


-- "*" denotes a spelling based on phonetics, 


without reference available. 


-- (inaudible)/ (unintelligible) signifies speaker 


failure, usually failure to use a microphone. 

 

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P A R T I C I P A N T S 


(By Group, in Alphabetical Order) 


BOARD MEMBERS
 

EXECUTIVE SECRETARY
 

WADE, Lewis, Ph.D. 


Senior Science Advisor 


National Institute for Occupational Safety and Health 


Centers for Disease Control and Prevention 


Washington, DC 


BRANCHE, Christine, Ph.D. 


National Institute for Occupational Safety and Health 


Centers for Disease Control and Prevention 


Washington, DC 


MEMBERSHIP
 

BEACH, Josie 


Nuclear Chemical Operator 


Hanford Reservation 


Richland, Washington 


GRIFFON, Mark A. 


President 


Creative Pollution Solutions, Inc. 


Salem, New Hampshire 


LOCKEY, James, M.D. 


Professor, Department of Environmental Health 


College of Medicine, University of Cincinnati 


MELIUS, James Malcom, M.D., Ph.D. 


Director 


New York State Laborers' Health and Safety Trust Fund 


Albany, New York 


MUNN, Wanda I. 


Senior Nuclear Engineer (Retired) 


Richland, Washington 

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IDENTIFIED PARTICIPANTS
 

BEHLING, HANS, SC&A 


BERMINGHAM, SARAH, SEN. SCHUMER 


BROEHM, JASON, CDC WASHINGTON 


BURGOS, ZAIDA, NIOSH 


ELLIOTT, LARRY, NIOSH 


HINNEFELD, STUART, NIOSH 


HOMOKI-TITUS, LIZ, HHS 


HOWELL, EMILY, HHS 


KOTSCH, JEFF, DOL 


MAKHIJANI, ARJUN, SC&A 


MAURO, JOHN, SC&A 


STAUDT, DAVID, CDC 

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P R O C E E D I N G S


 (2:00 p.m.) 

WELCOME AND OPENING COMMENTS
 

DR. CHRISTINE BRANCHE, DFO
 

DR. BRANCHE: Welcome to the conference call 


for the working group on surrogate data. 


Thank you for joining the call. I want to 


make sure, do a short roll call to make sure 


that we have members of the committee. Jim 


Melius. 


DR. MELIUS: Yes, I’m here. 


DR. BRANCHE: Josie Beach. 


MS. BEACH: I’m here. 


DR. BRANCHE: Mark Griffon. 


MR. GRIFFON: Here. 


DR. BRANCHE: Jim Lockey. 


DR. LOCKEY: Here. 


DR. BRANCHE: Wanda Munn. 


MS. MUNN: Here. 


DR. BRANCHE: And then, Stu, you’re sitting 


in for Jim Neton? 


MR. HINNEFELD: That’s correct. 


DR. BRANCHE: John Mauro. 

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DR. MAURO: Yes, I’m here. 


DR. BRANCHE: Are there other people who’d 


like to introduce themselves? Let’s start 


with other people within NIOSH, please. 


MR. ELLIOTT: Larry Elliott is here. 


 DR. WADE: Lew Wade is here. 


MS. BURGOS: Zaida Burgos. 


DR. BRANCHE: Other people from HHS. 


MR. STAUDT: This is David Staudt from PGO 


of CDC. 


MS. HOMOKI-TITUS: Liz Homoki-Titus with 


HHS. 


MS. HOWELL: Emily Howell with HHS. 


MR. BROEHM: Jason Broehm in the CDC 


Washington office. 


DR. BRANCHE: Are there others from other 


federal agencies? 


MR. KOTSCH: Jeff Kotsch with Department of 


Labor is here. 


DR. BRANCHE: Any other members? Anybody 


else who would like to offer their names? Any 


members of the public? 


DR. MAKHIJANI: This is Arjun Makhijani from 


SC&A. 


DR. BEHLING: Hans Behling, SC&A. 

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DR. BRANCHE: Okay -- I’m sorry. Did I cut 


someone off? 


MS. BERMINGHAM: This is Sarah Bermingham in 


Senator Schumer’s office. 


DR. BRANCHE: Thank you. 


All right, we have a quorum of the 


group, and but yet not of the Board. Isn’t 


that right, Lew? 


 DR. WADE: Correct. 


DR. BRANCHE: Thank you for participating in 


the call. We do ask that if you’re not 


speaking, if you could please mute your phone 


so that others can hear what’s going on in the 


call. The background noise can often make it 


difficult for every word of the speaker to be 


heard. And if you don’t have a mute button, 


if there’s some way for you to cover the 


receiver of the phone that would be helpful. 


We’re going to start with some 


information from Liz Homoki-Titus, and then 


we’ll go on to the Chair, Dr. Jim Melius. 


Liz. 


MS. HOMOKI-TITUS: Thank you, Dr. Branche. 


Based on a document that was recently 


produced by SC&A that the Office of General 

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Counsel received yesterday, I need to remind 


the Advisory Board that SC&A is not a legal 


advisor to the Advisory Board or to Health and 


Human Services. It’s not appropriate for SC&A 


to provide legal analysis or opinions on the 


statute or regulations to the Advisory Board 


in this format, i.e., the document that they 


provided to you, or any other format. We’re 


asking that you do not rely on any of the 


opinions that SC&A provided you in this 


document since they’re inappropriately 


provided and a number of them are incorrect. 


I’d also like to remind you that any 


legal or interpretive questions regarding the 


statute or the regulations are to be made by 


HHS. And if you ever have any questions 


regarding the proper interpretation of EEOICPA 


or the statutes, you need to provide them to 


Lew Wade or whoever your designated federal 


official is and then the program will be in 


touch with the Office of General Counsel to 


reply to the Advisory Board as appropriate. 


If I may, I would like to remind you 


what your statutory duty is as an Advisory 


Board, and I’ll be repeating this information 

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to the full Advisory Board at the meeting on 


Tuesday. According to the Energy Employees 


Occupational Illness Compensation Program Act, 


which can be found at 42, USC, Section 73840 


which describes the Advisory Board’s duties. 


It reads, quote, “Advisory Board on Radiation 


and Worker Health, Section B, Duties, The 


Board shall advise the President on, number 


two, the scientific validity and quality of 


dose estimations and reconstruction efforts 


being performed for purposes of the 


compensation program.” 


There is nothing in EEOICPA or in the 


charter that gives the Advisory Board 


authority to advise the Secretary on legal 


issues or to seek illegal advice from your 


contractor. 


Thank you. 


DR. BRANCHE: Thank you, Ms. Homoki-Titus. 


Dr. Melius, I’ll turn it over to you. 


DR. MELIUS: I’d like to make one correction 


to what Liz said. I think it’s fair to say 


it’s her opinion that some of these may be 


incorrect, but it’s only the opinion of the 


General Counsel of HHS. It may not be 

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necessarily true. Opinions can --


MS. HOMOKI-TITUS: The opinion of the Office 


of General Counsel is the one that provides 


you with the legal interpretation of EEOICPA. 


DR. MELIUS: As I said, it’s an 


interpretation. 


MS. HOMOKI-TITUS: Right, and that’s HHS’ 


interpretation, and that’s the interpretation 


for the Advisory Board. The Advisory Board 


was provided with the interpretation of 


EEOICPA on this question, and you charged your 


contractor with a specific duty which our 


contractor went outside of. So therefore, 


we’re advising you that SC&A is not your legal 


advisor. The opinions provided are not the 


proper opinions or interpretation of EEOICPA. 


INTRODUCTION BY CHAIR
 

DR. MELIUS: What I’ve asked John to do 


today is to walk through the reports because 


we had not had an opportunity to meet and 


discuss this before. And so if John could 


walk through the two reports to brief 


everybody on what the content is, does not 


take long. And then I’d like to talk mainly 


about how we move forward from here. 

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DR. MAURO: I’d be happy to do that. Can 


everyone hear me okay? I’m on my cell phone. 


MS. MUNN: Yes, John, but before you start 


this is Wanda. I’m sorry, Jim, you said two 


documents. I was only looking at the 


Surrogate Data Report from SC&A of 11/06. Is 


there another document that we should be 


looking at simultaneously? 


DR. MELIUS: Yeah, there’s a September 12th , 


2007, document. 


MS. HOMOKI-TITUS: Dr. Branche, I don’t 


think anybody in OGC has received that. Could 


you please e-mail it to us? 


DR. BRANCHE: I’ll make sure that it gets to 


you. 


MS. HOMOKI-TITUS: I have the November 6th
 

document. I don’t know if Emily has the other 


one. 


DR. BRANCHE: Emily, do you have the other 


one? 


MS. HOWELL: I’ll have to double check. I 


don’t believe I do. 


DR. MELIUS: It’s actually the one that we 


discussed in that brief working group meeting 


at the last Board meeting. 

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MS. HOMOKI-TITUS: I definitely don’t have 


that document. If I could get someone to send 


me that right now so that we can follow along 


with this discussion. 


MR. HINNEFELD: This is Stu Hinnefeld. I 


can do that. 


MS. HOMOKI-TITUS: Thank you. 


DR. MELIUS: Okay, Stu, because if not I 


can. 


DR. LOCKEY: This is John Lockey. Would you 


send that to me because I had to leave early 


before that ad hoc meeting in September. 


MS. CHANG: This is Chia-Chia. Will you 


send that to me please, also? 


MR. ELLIOTT: This is Larry Elliott. I 


would just like to note for the audience on 


the line that’s outside of this government 


circle here that these two documents from SC&A 


are working draft documents, and they have not 


been made public at this point in time. So 


there is no copy on the website for review for 


the public. 


DR. MELIUS: Can I ask the status of the 


September 12th document then? 


MR. ELLIOTT: You’re asking that of me, Jim? 

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DR. MELIUS: Well, I’m asking, well, I never 


know who to ask that of, Larry. 


MR. ELLIOTT: I can understand. Well, since 


Liz or Emily doesn’t have it, I suppose they 


have not had a chance to review it for 


redaction although I’m not sure, that I may be 


misspeaking there because perhaps John Mauro 


should speak to this. I’m not sure if John 


Mauro and SC&A felt that that document was at 


a state of completion they wanted it reviewed 


for public distribution. So I don’t know. 


DR. BRANCHE: I don’t have a copy of it 


either. 


 DR. WADE: John, maybe you could talk to us 


about the status of that document. 


DR. MAURO: Certainly --


MS. MUNN: It’s a problem because if I filed 


it, I did not file it under the heading 


Surrogate Data, which would have made it 


easier for me to find. So this is Wanda, and 


I’m struggling trying to find it, too. 


MR. HINNEFELD: I’m adding names to my 


address list here. 


 DR. WADE: Well, let John though speak to 


what the document is. 

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SURROGATE DATA DRAFT REPORT OF SEPT. 12, 2007
 

DR. MAURO: Yes. We delivered a draft 


report dated September 12, 2007, to the 


working group which I referred to as more of a 


survey or a compendium which describes the 


degree to which surrogate data of various 


types were used in various site profiles, 


primarily site profiles. 


As you know SC&A has reviewed 21 site 


profiles, and the question that was posed to 


SC&A is for us to go back to our review of 


those documents and identify places where the 


site profile -- in other words, the primary 


mission -- made use of surrogate data from 


other sites. In other words are there any 


site profiles that took advantage of data and 


information from sites other than the site for 


which the site profile was prepared in order 


to supplement, complement, help fill in the 


blanks, the site profile for a given site. 


That report was delivered on September 


12th, and it’s primarily a compendium of 


information, a large table. And that was 


delivered. And subsequent to that once the 


compendium was there a question arose, okay, 

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now that we have a set of how and to what 


degree other site data is being used in 


various site profiles, in various procedures 


and also in various dose reconstructions at 


least based on the slice that we view, and in 


terms of the site profiles we reviewed; the 


SEC petitions we reviewed, the evaluation 


reports and the dose reconstructions that we 


reviewed. We provided that information. 


Then subsequent to that the working 


group convened --


 DR. WADE: Can I stop you for just a moment, 


John, just to -- so the September 12th document 


has not been submitted as a contract 


deliverable? 


DR. MAURO: No, it was delivered as a draft 


report solely to the working group. 


 DR. WADE: So you haven’t submitted it for a 


Privacy Act review at this point? 


DR. MAURO: No, it has not. 


 DR. WADE: So I just want to get that on the 


record. If it’s the desire of the work group 


to do that, then we can talk about that. But, 


okay, fine, you can go ahead, John. 


DR. MELIUS: And I would say that it is the 

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desire of the work group. 


 DR. WADE: Okay, John. 


DR. MELIUS: I mean, I think we need to get 


this out so that we can --


 DR. WADE: So then the action, John, would 


be for you to submit it through the channels 


that have been developed. 


DR. MAURO: Certainly, and we do have a 


follow-up procedure for doing that. It goes 


to our point of (inaudible), and certainly I 


will advise Nancy to get in touch with Liz. 


Okay, let’s put this one in the queue for 


putting it through Privacy Act review, no 


problem. 


 DR. WADE: So then you can continue, John. 


I’m sorry. 


MR. HINNEFELD: Real quick, this is Stu 


Hinnefeld. I’m preparing to forward this to 


Liz, Emily, Chia-Chia, Dr. Wade, Dr. Branche, 


Dr. Lockey, Ms. Munn and Ms. Beach, I think, 


was the one that said she didn’t have it. 


Anybody else? 


MS. BEACH: I actually have it. Mine was 


dated November 6th . This is Josie. Is this 


that correct --

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MR. HINNEFELD: I think this is a different 


one. I believe this is an earlier report from 


DR. MELIUS: It’s an earlier one, Josie. 


MR. HINNEFELD: Then I will send. 


 DR. WADE: You’re a good man, Stu. 


MR. HINNEFELD: I trust that will be the sum 


total of my contribution. 


MS. MUNN: Probably not. 


DR. BRANCHE: Thank you for sending it. 


So, John, please continue. 


 (no response) 


DR. BRANCHE: John Mauro? 


 (no response) 


DR. BRANCHE: John, did you have the floor? 


 DR. WADE: I wonder if we have John or not. 


That’s more the issue. We might have lost 


contact. I assume if we did, he would call 


right back in. 


MS. MUNN: Well, he said he was on a cell 


phone so that may create a problem. 


DR. BRANCHE: Dr. Melius, could you please 


(inaudible)? 


DR. MELIUS: Yeah, I’m here. I just, sort 


of waiting. I’d asked John to do the summary. 

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 DR. WADE: Let’s give John a minute to call 


back in. He’s a resourceful fellow. He’ll 


solve the problem. 


DR. MAURO: Hello, this is John Mauro. 


 DR. WADE: Told you. 


DR. MAURO: I was on the cell phone and for 


some reason we lost connection so I called 


from a land line, so I’m back online. Should 


I continue? 


DR. BRANCHE: Please do. 


DR. MAURO: I’m sorry for that. That’s one 


of the problems with cell phones. 


During the Naperville meeting on 


October, I believe it was on October 4, 2007, 


there was a brief meeting of the working group 


whereby we very briefly discussed that 


September 12th report. And the working group 


then asked if SC&A would prepare a supplement 


to that report which, in effect, the direction 


was to come up with suggested technical review 


criteria for the appropriate use of data from 


other sites which is the document that you 


have before you that’s dated November 6th, and 


it’s titled “Supplementary Report Concerning 


the Use of Data from Other Sites”. 

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And our direction was to, when we 


explore this issue, to make it as regulatory 


driven as we could. In other words given the 


regulations, and how they’re framed to come up 


with suggested technical criteria for the 


conditions under which according to the 


governing regulations would appear to be the 


drivers for when and under what conditions it 


would be appropriate to use surrogate data for 


other sites. And that was my understanding of 


our mission, and that’s described in the 


introductory language to this relatively brief 


report which is about six or seven pages. 


So given that what I did, and I think 


this is where the offending language came in, 


that is, I went through and I read, I started 


with the statute, and I read the statute very 


carefully to judge is there any language in 


there that would speak to the question of the 


use or non-use of other site data in 


performing dose reconstructions. And as you 


may have noticed, I try to quote those 


portions of the statute, starting with the 


statute, that might, might directly or 


indirectly be relevant or related to that. 

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And basically what I concluded was, 


well, the statute really is silent, but I did 


make one conclusionary statement. That’s on 


page two of my report toward the bottom which 


I suspect is probably part of the problem that 


we’re discussing today whereby -- I’ll 


actually read the words that I wrote that 


says, “the law itself is somewhat ambiguous 


but may imply that data used for dose 


reconstruction should be from the same 


facility where the employee worked.” 


As I pointed out in the introduction, 


this is purely my reading or our reading, 


SC&A’s reading, and I was trying my best to 


communicate my sense of the degree to which 


there’s any direction given in the statute. 


And we came away with that conclusion. And I 


suspect that that’s probably one of the places 


where there’s some concern. 


The report then goes on --


MS. HOMOKI-TITUS: John, there’s a number of 


places that are as much, probably even more 


concern than that, and I’m not comfortable 


with you going through this document and 


providing your legal opinions that you 

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provided in it. 


DR. MAURO: Yeah, I was hoping they wouldn’t 


be legal. What I was doing, the way I think 


about this is I was doing what I used to do 


which is called a licensing engineer. For 


many, many years my role at engineering 


companies was to read the regulations that 


were in place and try to help identify what 


the technical implications are of those 


regulations so that the engineers and 


scientists would be preparing their work 


products, like environmental impact statements 


or safety analysis reports that met the letter 


and intent of the governing regulations. 


So the way I look at this is sort of 


as a bridge, a technical bridge, that says, 


okay, as best I can tell this is the 


regulatory drivers. So it’s something that 


I’m very familiar with and have done quite a 


bit of on behalf of the design of nuclear 


power plants, for example. But in any event 


that’s what I did, and I take full 


responsibility. 


And then I moved on to do the same 


kind of thing, you’ll see on the bottom of 

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page two, Section B, you’ll see a brief review 


of CFR-81. And then I go on to CFR-82 and 


then CFR-83 where I effectively, to the best I 


could, summarize those portions of the 


implementing regulations that say something 


either directly or indirectly that might be 


pertinent regulatory drivers pertaining to the 


use of other site data. 


And then I conclude the report on page 


seven with three -- and this is my creation, 


three what I call technical review criteria 


that says, gee, as best I can tell from 


reading the regs, these would be what you 


would use as your, in other words if someone 


were to be, was about to use other site data 


to let’s say support a site profile or a dose 


reconstruction, it seems to me the regulations 


would establish, at least give you some ground 


rules that you could interpret as best I can 


tell, and these would be the criteria, these 


three that I wrote here. 


And I don’t know if it’s necessary to 


go through them, but it’s my construct of what 


I believe to be technical review criteria that 


would be almost like a test. You could use, 

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based on reading the regs, it seems that you 


could use other site data, especially under 


part 83, but it also seems that there are 


certain tests that you have to meet, you know, 


criteria, technical criteria, that need to be 


met before you could leap to other site data 


as the basis for, let’s say, doing your review 


of compliance with part 83 and also part 82. 


And that’s what this report was. And 


so in summary without going into the details 


of those criteria, this is my contribution to, 


my response to the directives that we received 


from the working group. 


DR. MELIUS: What I’d like you to do, John, 


is to just briefly describe the three 


technical criteria. 


DR. MAURO: Sure. 


DR. MELIUS: Because I think aside, I mean, 


aside from the regulatory issues, I mean, the 


regulations reflect the, essentially were to 


enable what would be a procedure for doing 


dose reconstruction. And I don’t think that 


the criteria are as much regulatory driven as 


they are sort of what are the procedures we’re 


going to put in place for doing dose 

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reconstruction. 


And I think that’s what we want to 


focus on in the working group is the technical 


side of these issues and not the regulatory or 


legal side. And frankly, as far as I’m 


concerned, and others may feel differently, if 


Liz or General Counsel’s Office finds the 


first six pages so offensive or difficult, 


they can be taken out. Because I think what 


the key to this and for our working group 


going forward is page seven on. 


MS. HOMOKI-TITUS: The only part we want 


taken out is where legal conclusions are 


drawn. Where he lists what part of the 


statutes are appropriate is fine. 


DR. MELIUS: Yeah, I mean, you can work that 


out. I’m not trying to, but it does, really, 


you approached it in the way you’re used to, 


John, and that’s fine. But if you think about 


it, it also reflects what procedures Larry and 


his group and his contractors do in doing dose 


reconstructions that we’re all familiar with 


and in part of now. 


And the idea is how do we put the use 


of surrogate data in the framework of the 

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current program in sort of a technical 


procedural way, not in a legalistic approach 


to that. So if you could just go through 


those because I think that’s what I’d sort of 


like to focus our attention on in this brief 


call. 


DR. MAURO: I’d be glad to, and they’re 


really relatively brief. They start on page 


seven, and the first one that I call 


“Technical Review Criterion One” -- and I call 


that hierarchy of data, and I do cross-


reference the part 82 section that I felt was 


applicable here. 


And it really boils down to that what 


I’m offering is the second paragraph in that 


section that says, “under this technical 


review criterion” -- which I’m suggesting --


“NIOSH would need to demonstrate that good 


faith effort was made to use worker-specific 


workplace-specific and site-specific data 


before resorting to data from other sites to 


replace, complement, supplement or confirm 


data of greater stature in the hierarchy of 


data.” 


So the way I read it is this. There 

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is a hierarchy of data that needs to be used 


and preference is given to site-specific data 


and before you resort to other site data, you 


would want to make sure you worked your way 


starting with the onsite data and demonstrate 


that an attempt was made to do that. 


MR. ELLIOTT: John, this is Larry Elliott. 


Just if I could jump in --


DR. MAURO: Sure. 


MR. ELLIOTT: I offer a point of 


clarification. The hierarchy of data that is 


presented in our regulation specifies the 


preferences being on individual monitoring 


data. 


DR. MAURO: Yes, but you do go to, for 


example, eventually you can go to criteria 


related to the operation of the facility in 


your different hierarchies. Well, for better 


or worse, I mean, I’m not saying --


MR. ELLIOTT: Not in the hierarchy, but the 


preference, the data that we prefer to use is 


individual monitoring data for individuals, an 


individual working at that given site. 


DR. MAURO: Right, right. Yes, and well, 


what I’m saying is that eventually if you do 

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use, move to data from another site, the 


philosophy being -- and this is my 


interpretation, and it was my offering so that 


it would actually initiate a discussion that 


we’re having right now. 


Before you move to, let’s say, using 


data from another site whether it’s air 


sampling data or bioassay data or whatever, 


data from another site, you would want to 


exhaust the availability of data from the site 


of interest. And that’s criteria number one, 


pretty simple and pretty straightforward. 


Then the second criterion, 


documentation, and it’s really related to the 


first one, is that at least some data was used 


from the site of interest. This goes, of 


course, to part 83 that actually explicitly 


requires that. But then I go on to explain 


that one of the areas that may need some 


further development related to that, what I 


call exclusivity constraints, is how much and 


to what extent would you define, that is, the 


rule in part 83 does require that at least 


some data be used from the site of interest. 


And all I’m really raising here is 

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there’s probably a little work that needs to 


be done to define what the threshold is for 


that. As I point out in this write up, I’ve 


seen it range from, for example, where the 


data from, when you take a position that, yes, 


we did use data from the site of interest. 


Perfect example as I point out in the 


write up is Bethlehem Steel where there’s 


quite a bit of site-specific data that was 


available, was used, and then you resorted to 


Simonds Saw data to sort of supplement that 


where some data was lacking. That would be a 


place where there was considerable amount of 


site-specific data used. To the other extreme 


would be, for example, TBD-6000 where just the 


knowledge that a site was a metalworking 


facility would be sufficient site-specific 


information. What I would call that would be 


very low threshold. 


And as long as you know that a site 


was a metalworking facility, uranium 


metalworking facility, that constitutes site-


specific information. And then you can move 


on and use TBD-6000 which is a compendium of 


information for many sites to supplement the 

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data for a given site. 


So I use that as two examples of the 


range of interpretation, and I guess the point 


being made here is that I guess it would be 


helpful to establish some type of reasonable 


threshold of when have you made use of onsite 


data, met the letter intent of part 83 and met 


some threshold. I think right now there’s a 


lot of judgment left on that. 


Finally, what I talk about in 


Criterion Three is really something that needs 


to be developed also. And when I prepared the 


compendium, you may, those of you who had an 


opportunity to look at it, you may have 


noticed that I described the type of surrogate 


data into different categories. I actually 


broke them into two types, one and two, and 


where you could see that there’s a vast array 


of other site data or surrogate data in 


general that is made use of, the conditions 


under which you would use other site data 


differs depending on what the data’s being 


used for. 


So what I describe here is that there 


probably is a need to provide some guidance as 

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to, this gets really into what you would call 


the implementation of this philosophy. You 


know, when would you use lower limits of 


detection from another site? When would you 


use bioassay data from another site, air 


sampling data from another site, under what 


conditions? 


For example, if you are going to take, 


a great example would be the Bethlehem Steel-


Simonds Saw example. Under what conditions is 


it appropriate to use air sampling data from 


one site to supplement data from another site? 


And there may be a lot of, I guess, guidelines 


that could theoretically be developed for each 


category of other site data that, and you may 


hold some data to a higher threshold because 


they’re more fundamental, for example, 


bioassay data or air sampling data which 


really go directly toward the dose 


reconstruction process. 


But other data such as what are you 


going to assume to be a default lower limit of 


detection. There may be a different threshold 


or criteria as applied to the use of neutron-


to-photon ratios, medical x-ray exposures. In 

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other words each one is, theoretically, you 


could draw upon experience at other sites or 


throughout the complex, and if you’re going to 


apply it to a particular site, there needs to 


be, what I see, some direction or guidance on 


under what conditions is it appropriate to do 


that. 


And that is really what I discuss 


under Technical Review Criterion Three. And 


that really boils down to my offering for the 


consideration by the working group in response 


to the questions that, well, I guess the 


mission that was given to SC&A. 


DR. MELIUS: Are there any questions for 


John? 


MS. MUNN: No, but this is Wanda. I have a 


comment with respect to his observation about 


the need for judgment as opposed to 


establishing some clear criteria. So far as I 


believe we have observed to-date, this 


hierarchy that we discuss is pretty well 


agreed to and understood by most everybody 


involved. It seems strange to me that we 


could consider the possibility of establishing 


guidelines for these circumstances where we 

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get down in the third, fourth levels of the 


hierarchy because each of the sites that we 


would be comparing would in most cases have 


such different histories even though they were 


doing the same kind of work. 


I don’t think we have assurance with 


respect to the time elements involved. It’s 


hard for me to see at this juncture how we can 


establish criteria and eliminate the need for 


judgment on the part of the individual dose 


reconstructor or the individuals who are 


reviewing the sites for an SEC. Maybe I’m 


missing some of the finer points, but I don’t 


see how we can eliminate the need for reliance 


on judgment at some juncture. 


DR. MELIUS: Yeah, I understand. I agree 


with you. I think John would. I think the 


issue is sort of maybe not what we call strict 


criteria, but it would be more there are maybe 


guidelines or factors that need to be 


considered as part of that judgment because 


you also want that judgment to be consistent 


from case to case so that, or situation to 


situation, so that you’re not ending up with 


vastly different types of judgment or you’d 

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have the situation where two people looking at 


the same situation would come up with very 


different interpretations or very different 


judgments. 


So there’s sort of, I think, a happy 


medium there where you provide the framework. 


And I actually think that many of the 


procedures that OCAS has developed are really 


providing guidance to the dose reconstructors 


recognizing that judgment is required but 


providing some framework for that judgment so 


that it’s done in a consistent and fair manner 


and reflects the overall approach of the 


program. 


Is that a fair way of putting it, 


Larry? 


MR. ELLIOTT: I appreciate what you said 


there, Dr. Melius, and I do agree. I think 


that’s been what we strive to do is provide 


instruction and guidance to make sure that we 


have consistent dose reconstructions. So 


anything that we can do to improve upon that, 


we certainly would be interested in doing. 


DR. MAURO: Larry, this is John. What drove 


me in the direction of the, especially the 

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third item, is I was thinking about the way in 


which other site data has been used. And the 


two places that come to mind immediately, 


something I became intimately familiar with, 


was Bethlehem Steel and TBD-6000. 


MR. ELLIOTT: Yes. 


DR. MAURO: And I thought they were very 


good examples of, okay, what happened with 


Bethlehem Steel where data from Simonds Saw, 


air sampling data, was used to supplement. 


And I said, hmmm, and I thought about it. A 


lot of thought went into that, that is, in 


terms of the design of the facility, the mode 


of operation, the type of ventilation system, 


the kind of equipment, the salt baths. 


In other words before that air 


sampling data were used a great deal of 


thought went into whether or not it’s prudent 


to do that. So of course, those judgments 


were made but not within a framework that had 


any guidelines that said, it almost was like 


good science. 


In other words let’s make sure we do 


our homework before we use the Simonds Saw 


data. And it’s very well documented in the 

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work that was done. So I said to myself, 


okay, what does this tell us. What does this 


precedent tell us? It tells us that, yeah, 


there probably are some guidelines that could 


be assembled of when you’re going to use air 


sampling data from one site. 


And then I went on and said, okay, 


what’s the other place where I have some 


pretty good experience. And I said, well, 


when I looked at TBD-6000, I said what do we 


have here. I said, well, you have a one-sizefits-all. If you’re a uranium metalworking 


facility, and you have very limited site-


specific information, you could resort to TBD6000 as a bounding default approach for doing 


dose reconstruction. 


I said, okay, what cautions should 


someone use, and basically what I pointed out 


was that -- and this is actually in the write 


up that you have before you -- is that, well, 


there is a certain degree of care that must be 


taken to make sure that the array of data upon 


which TBD-6000 is based, the measurements that 


were taken, the historical records, are, in 


fact, bounding and appropriately applied to 

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the particular case at hand where you’re using 


TBD-6000 as your other site data surrogate for 


exposures at a given site. 


And I think that one of the things, 


the cautions, I put in here is that having 


TBD-6000 is an extremely convenient tool, and 


in my opinion, and again, I’m talking from a 


technical perspective, there’s a place for 


such a tool. But, of course, it’s also easy 


to use, and there should be some criteria of 


when you resort to that and certain tests you 


may actually want to impose upon yourself as a 


dose reconstructor. 


And my sense is that right now the 


guidance in 6000 does say use site-specific 


information when you have it, but it doesn’t 


say too much about under what conditions 


should you use, if you don’t have site-


specific data, and you’re about to resort to 


TBD-6000, are there any questions you should 


ask yourself about what you’re about to do. 


And it seems to me right now I don’t 


believe that kind of guidance exists. And 


that was my intent in the third category. So 


I drew upon that experience to try to 

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generalize and create these criteria, and that 


was my intent. And so --


MR. ELLIOTT: The other point of guidance in 


TBD-6000 that I would point out, John, is that 


it specifies use for specific facilities down 


to the name of the facility. 


DR. MAURO: Yes, the appendices are there. 


There’s no doubt about it. 


MR. ELLIOTT: So that may, in some people’s 


mind I hope it may need to be explicit, but it 


would imply that before you pick this document 


up and use it for a facility not on that list, 


you better make sure you understand why it’s 


okay to use it, or you can’t use it. So maybe 


we need to look at it that way. 


DR. MAURO: I agree and keep in mind that 


the appendices are there, and they’re growing. 


So data is being compiled, and you certainly 


go to the appendices --


MR. ELLIOTT: Appendices really are 


developed, for TBD-6000 the appendices are 


developed for unique exposures that are not 


addressed in the cover document, the Technical 


Basis Document 6000 itself. So I just want to 


be clear on that point because I don’t want 

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people to become confused that the appendices 


speak to something more on uranium metal 


refining or manufacturing than is already in 


the TBD-6000. 


I don’t believe those appendices do 


that. I believe they only speak to unique 


exposures outside of the, like the Appendices 


BB for GSI and the Betatron. That only deals 


with that Betatron exposure, that appendix. 


See what I’m saying? 


DR. MAURO: Absolutely. I guess I’m going 


in the other direction, when you’re going to 


use the TBD-6000, and you don’t have an 


Appendix BB or CC, and you want to reconstruct 


the doses at a particular site. You don’t 


have the data. You have all the look-up 


tables which are well researched, but they are 


based on certain datasets. 


And all I was saying was that when 


you’re going to use that as your surrogate, 


perhaps it would be a good idea to have 


certain, I guess, a checklist to make sure 


that you have a full appreciation of how that 


dataset was compiled and why it is appropriate 


to use for the particular case at hand as a 

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bounding method or at least a claimant 


favorable method. I guess it’s as simple as 


that and not just go directly and resort to 


it. 


MR. ELLIOTT: I think we understand your 


point. 


DR. MAURO: Yeah, and that’s all I was 


offering up. So there’s nothing really very 


profound about my three criteria. They sort 


of fall right out of the regulations, and 


that’s the reason I put the regulatory review 


in the front. Because as I said, I do think 


in terms of regulatory-driven technical 


criteria. And that’s all I was trying to do. 


DR. MELIUS: Other comments? 


 (no response) 


DR. MELIUS: From anyone? 


MS. MUNN: Well, that certainly stirred up a 


storm, didn’t it? 


MR. ELLIOTT: Well, this is Larry Elliott. 


I would take us back to the other document 


that was presented to the working group on, 


dated September 12th . I believe it was before 


the last Advisory Board meeting. We, of 


course, at NIOSH haven’t responded to anything 

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I don’t believe yet that’s couched in that 


document. And we certainly, I think, may have 


some thoughts and ideas in reaction to how 


John has categorized or perhaps identified 


certain uses of surrogate data. So just want 


to put that marker out there that we haven’t 


had a, haven’t come back with any response, 


reaction or thinking about that yet, and we 


would like to do that. 


DR. MELIUS: Let me talk about what I see as 


a way forward. And part of it was, not that I 


necessarily disagreed with the September 12th
 

document, but as much as I didn’t think it 


provided enough of a framework for us to do 


what we need to do in terms of this particular 


working group. And I thought we ended up, we 


end up really getting into sort of the weeds 


of what Wanda’s Procedures work group is 


focusing on it. 


It didn’t make sense to have two 


groups doing some of the same thing. So it 


was in reaction to that document that I asked 


John to do the second document as a way of 


sort of stepping back a little bit and 


thinking about how would we judge, how would 

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we develop a set of guidelines that would sort 


of provide a framework for the use of 


surrogate data in this program. And what I 


would have in mind going forward is that we 


produce a document that is similar to the SEC 


review document that we put together a couple 


years ago now at least, doing that that would 


try to lay out the framework and guidelines 


within that framework for the review of, for 


the use of surrogate data in this program. 


And it would not necessarily try to 


address particular instances, though I think 


it should be informed by particular uses that 


are already in place, but wouldn’t, because I 


think you want it to be useful. You don’t 


want to be having a set of guidelines that 


don’t apply to anything that’s being used but 


reflect the variety of uses as well as some of 


the complexities of this program and the 


issues of judgment and so forth that Wanda 


raised into that. 


And I guess I’d like people’s reaction 


to that as a way forward because I think this 


particular issue obviously is a source of 


heartburn for all of us in many ways. It 

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gives the Legal people heartburn because of 


what’s in the regulations and law and so 


forth. And it obviously, Larry, and I think 


all of us, have to be concerned that we’re 


already doing a lot and already using 


surrogate data a lot in this program. And we 


have to be mindful of that and the fact that 


we are comfortable in its use in many 


instances. 


And so I think what may be more useful 


both in a sense of going forward is having a 


document that looks at it from a sort of 


overall guidelines criteria perspective like 


the SEC document. So I guess I would be 


interested in people’s reaction to that. 


MS. MUNN: This is Wanda. I’m not at all 


sure I understand the format that you are 


suggesting, Jim. Are we discussing the 


insertion of some criteria in, for example, a 


workbook? Or are we considering something 


else? 


DR. MELIUS: It would be a document. It 


would be entitled as a straw document so to 


speak, you know, “Guidelines for the Use of 


Surrogate Data in the Dose Reconstruction 

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Program”. And it would list the various 


criteria, I think, using, say starting with 


something equivalent to the three criteria 


that John has starting on page seven of the 


second SC&A report, and an explanation of how 


those would be applied. And then it may have 


some procedural recommendations also. 


MS. BEACH: This is Josie. Do you mean 


procedural recommendations or would we 


actually make this a procedure? 


DR. MELIUS: It wouldn’t be a procedure. 


This would be sort of an overall guidance 


document like the original SEC review 


document. Again, what we did there was 


produce a set of guidelines and general 


criteria that would be used in the review of 


SEC evaluation reports. And these would be 


things, was basically was designed to be the 


type of information that would be a guide for 


OCAS in preparing the evaluation reports, and 


I don’t want to say a checklist, but sort of a 


general type of areas that the Advisory Board 


felt should be focused on in the review of 


those evaluations. 


MR. ELLIOTT: I thought you were starting 

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off with this being a Board-related tool, but 


now it sounds like it’s, you’re leading it 


more to a guidance tool that we would use. 


DR. MELIUS: Well, I think it’s both. I 


think the SEC ended up in some ways being both 


because you used it as a -- correct me if I’m 


wrong, Larry -- but as a way of, sort of an 


outline for your reports, SEC evaluation 


reports, the things that would be covered in 


them. And then the Board used it as a way of 


how we would evaluate. 


MR. ELLIOTT: Yeah, essentially how I recall 


that going down was the Board through your 


working group provided some recommendation on 


how to develop an evaluation report that 


addressed some things, some elements, some 


concerns, some problems that you were seeing 


in our evaluation reports. And you wanted to 


make sure that we attended to those, and we 


accepted that recommendation, and we started 


living by that. So that could happen here, I 


guess. 


DR. MELIUS: Yes, I mean, I think that 


there’s differences clearly. I mean, I think 


the use of surrogate data is in some ways more 

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diverse. There’s different --


MR. ELLIOTT: Yeah, it is. 


DR. MELIUS: -- yeah, and so I think, yeah, 


some guidelines may apply, some criteria may 


apply to one use, it may not apply to another. 


And I think we have to try to make sure we 


reflect that and so forth. What I’m thinking 


of like a procedural recommendation, I mean, 


there may be things like I would actually 


(sic) responding to something you had just 


said, Larry, which was for the 6000 procedure, 


the appendices deal with unique situations. 


MR. ELLIOTT: Yes. 


DR. MELIUS: Essentially the exceptions. 


Well, maybe one procedural recommendation is 


that there should be an explicit procedure for 


dealing with the exceptions. 


MR. ELLIOTT: Or site profiles or technical 


basis documents that utilize surrogate data 


need to be explicit in how that came to be. 


Maybe that’s where we --


DR. MELIUS: Yeah, exactly, exactly. 


MR. ELLIOTT: -- because I think we do it a 


little bit of justice and service in some of 


our documents while in others perhaps we are 

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not as explicit as we should be about the use 


of surrogate data. 


DR. MELIUS: And we all recognize some of 


that as the programs mature then as we all 


gain experience, and particularly your group 


gains experience doing literally thousands of 


dose reconstructions that situations become 


more evident. I guess others on the work 


group? Do I have you completely puzzled? 


DR. LOCKEY: Yeah, Jim, Jim Lockey. I just 


maybe a further explanation for me (sic). 


What you’re suggesting is that when surrogate 


data is felt to be appropriate, appropriate 


for use by NIOSH, this is the hierarchy as to 


how that data would be used. Is that what 


you’re suggesting? 


DR. MELIUS: No, these would be guidelines 


that would guide the consideration of the use 


and the utilization of surrogate data. 


DR. LOCKEY: So what you’re proposing is a 


step before that. In other words a step in 


regard to how NIOSH arrives at the decision 


that surrogate data is appropriate for use. 


DR. MELIUS: But I actually think that’s 


part and parcel of what goes on already. I 

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mean, I’m sure that, you know, some of it’s 


sort of obvious. If you have adequate data 


for the site, you don’t consider it, right? 


So that already goes on. That’s part of the 


hierarchy. 


MS. MUNN: Yeah, this hierarchy has 


essentially been in place from the outset. 


DR. MELIUS: One mustn’t rewrite the 


hierarchy. So it’s guidelines on, if 


essentially those guidelines aren’t met, 


you’re not going to do it so to speak. But I 


mean --


DR. LOCKEY: That’s what I’m asking. Since 


the hierarchy’s in place and that, then what 


are you proposing? That’s what I’m having 


trouble. 


DR. MELIUS: I think there are criteria 


beyond just the hierarchy, and there are 


criteria as to what is the, let’s call it the 


suitability of surrogate data. I mean, one, 


it’s not always available. It doesn’t always, 


there’s many cases where it’s not going to be 


used. 


MR. ELLIOTT: Jim, if I might maybe I can 


help out here and explain as I see what you’re 

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talking about for Dr. Lockey here. 


If we take the Bethlehem Steel example 


that John Mauro spoke of earlier, and we 


identified that we had some data gaps. In 


that instance we didn’t have enough exposure 


monitoring data, and it led us to use air 


monitoring data. And we still felt we needed 


a little bit better handle on that aspect. 


And we looked around, and we said, well, here, 


we’ve got another site that was a pilot 


operation similar to Bethlehem Steel. They 


were rolling uranium. In fact, they were 


trying the same process at Simonds as they 


were trying to do at Bethlehem. And they 


learned something at Simonds that they applied 


at Bethlehem. So maybe there’s some data at 


Simonds that we can use to bound doses at 


Bethlehem. And so that’s exactly what we did, 


but we didn’t explain perhaps clearly and well 


enough and thoroughly enough why we felt we 


could use that data from Simonds. It could 


have been that we looked at that Simonds data 


and said, well, we can’t use that, and we 


should explain why we couldn’t use that. I 


think that’s where Dr. Melius is going. 

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DR. LOCKEY: I understand. I assumed that 


that’s what you were doing. What I didn’t 


understand was that the justification of your 


decision was not recorded. 


MR. ELLIOTT: Well, I would say it is 


recorded, but perhaps it could be more 


explicit than it is. 


DR. MAURO: This is John. I was very close 


to the evolution. And one of the concerns 


throughout the process in the review of 


Bethlehem Steel was the use of Simonds Saw 


data. And during the deliberations a great 


deal of information was brought forth to 


describe why the data that was used from 


Simonds Saw was appropriate in this 


circumstance. So that emerged during the 


course of our deliberations. 


So in a way that process represents a 


good example of the kinds of deliberations 


that were used in the past to get to the point 


where it was generally felt that we can do it 


under those circumstances. And in a way that 


very same deliberative process is appropriate 


for any time you’re going to draw upon other 


site data to help supplement the data you have 

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for a given site. So that’s why I went to 


Bethlehem Steel as a good example. And that 


deliberative process emerged. That wasn’t 


something that was self evident from the very 


beginning. It emerged during the course of 


working through some of the issues that we 


raised related to Bethlehem Steel. 


DR. MELIUS: I mean, even if you, another 


way of stating more generally, well, if data’s 


not available from a site for a particular 


process or something or whatever. OCAS will 


say, well, we’ll consider the use of data from 


another site, surrogate data. Well, under 


what criteria would you do that? I mean, and 


he’d say, we’ll, we’d use our judgment. Well, 


what goes into that judgment, and how is the 


decision made to use it? 


But once a review takes place of that 


information that would determine that it’s 


appropriate and that it is applicable in that 


situation. Now clearly, these situations are 


diverse, so we’re not going to try to produce 


a document that covers every specific 


situation, but I think there are some general 


criteria that -- I mean, again, the same with 

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the SEC. 


All the sites are different and the 


criteria, the evaluation document does not 


cover every situation or every consideration, 


but I think it provides a framework, and I 


actually think the process helps to, you know, 


both the Board and the Board working with 


NIOSH to sort of have a consensus on how we 


will go forward on, you know, in one case the 


review of SEC evaluation reports and the other 


case with whatever Larry and the group propose 


the use of surrogate data for a particular 


situation or as part of a particular procedure 


or dose reconstruction. 


DR. BEHLING: Dr. Melius, can I make a 


comment here? This is Hans Behling of SC&A. 


DR. MAURO: This is John. If it’s okay, I 


would like to break. I am in a position where 


it’s very difficult for me to continue on the 


line. If you’ll forgive me, but certainly, 


Dr. Melius, if I could give you a call at a 


convenient time, any actions you’d like us to 


take I certainly could discuss it, but I do 


have to break right now. 


DR. MELIUS: Okay, John. 

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DR. MAURO: Okay, thank you very much. 


DR. BEHLING: Dr. Melius, can I make a 


comment here? 


DR. MELIUS: Yes, go ahead, Hans. 


DR. BEHLING: And I guess we’ve discussed an 


awful lot about when is the use of surrogate 


data appropriate, and what are the potential 


criteria. And I think collectively we can 


talk about the degree to which surrogate data 


has parity with the facility for which we have 


no data. And parity is really based on the 


number of criteria that can be used. 


For instance, time is a critical 


aspect as was the case with Simonds Saw and 


Bethlehem Steel. The two facilities operated 


during the same time period so time is of 


critical importance of significance in the 


sense where you wouldn’t want to compare a 


facility that’s operating currently with one 


that operated in the ‘50s and ‘60s. 


The other issue is one of the 


facility. The engineering controls, the 


design of the facility. Another one would be, 


for instance, the quantity of materials 


processed. You cannot compare a facility that 

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processed a very small quantity with a 


facility that processed megatons. 


Another one would be the role of the 


processes, the type of processes. Are they 


identical or is there parity between the 


chemical processes or the mechanical 


processes. And lastly, there may be issues 


regarding a known or established radiological 


incident that would perhaps make one facility 


not appropriate for it to another facility. 


So these are all the criteria. And 


collectively, I think the importance here in 


using surrogate data is to establish a degree 


of parity that says, yes, they are close 


enough or nearly identical to the point where 


there’s no reason not to use it as opposed to 


recognizing their differences in design, in 


facility designs, the differences in the time 


periods during which they operated at 


differences in the processes that were used 


for the same endpoint. 


All these things would either 


determine whether or not it’s appropriate to 


use surrogate data or perhaps the use of 


surrogate data has certain limitations to it. 

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And I think there could be a reasonable, easy 


checklist that would essentially provide an 


overview in saying, yes, there is tremendous 


amount of overlap here between these two 


facilities that would make one set of data 


very appropriate for use at a facility that 


lacks that data. 


DR. MELIUS: Thanks, Hans, I think that’s 


helpful. 


Anybody else have comments? 


MS. MUNN: If we can all get on the same 


page with this it would be enormously helpful 


for all of us I think. And it’s of extreme 


interest not only to the people that we have 


on the call here, but certainly this is a real 


hot button for most of the claimants who 


cannot understand why it would be beneficial 


for us to be using data from some other site. 


It’s, I think, really important for us to be 


able to all agree what these guidelines are 


appropriately without obliterating the fact 


that we’re always going to have judgment calls 


that are involved here. I see no way we can 


ever avoid that. 


DR. MELIUS: Other comments? 

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MS. BEACH: I have a question. Will we use 


any of these recommendations to go back and 


look at previous dose reconstructions and how 


they were used, or will we just be going 


forward at this point? 


DR. MELIUS: I think it’s, in essence, it’s 


going, in some ways it’s going forward, but 


this -- I don’t know how to state this, but 


essentially the program is sort of always in 


flux in the sense that procedures are always 


being updated and changed and so forth. And 


I’m not, I think we have a, for example, a 


Procedures work group that’s underway and to 


the extent that we have a document for them 


relatively soon, they will use that. I think 


that as always whenever anything changes in 


this program, if it’s felt that it would have 


an impact on a set of dose reconstructions 


that had been done in the past where it might 


need to be reviewed, then I think NIOSH’s 


policy has been to go back and look at those 


and see if it does change it. But that’s 


probably jumping ahead, and I’m not predicting 


that’s what --


MR. ELLIOTT: This is Larry Elliott. 

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DR. MELIUS: Larry, I don’t want to --


MR. ELLIOTT: If I could, I would speak to 


Josie’s question with this answer. Josie, we 


here at NIOSH don’t believe that we have made 


use of surrogate data inappropriately up to 


this point in time. We’ve been very careful, 


in fact, with when and where we use it, fully 


recognizing that it should be used 


appropriately and to the advantage of the 


claimant, not to a disadvantage. 


And that somewhat is in the eye of the 


beholder I know, but we would, if it comes to 


pass that we have used surrogate data outside 


of any guidelines or checklist or criteria 


that gets established through this 


deliberative process that we’re engaged in 


right now, we would then go, and if that, in 


fact, added dose, that changed added dose, 


then we would institute and implement our 


program evaluation review to look at all noncompensable claims that came from that misuse 


of that data. But it’s only when we increase 


dose do we look back at claims. If we 


decrease dose, we don’t go revisiting claims. 


MS. BEACH: Thank you. 

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MS. MUNN: My guess would be that what we 


ultimately determine our suggestions to be 


will not vary in large degree from what has 


been done in the past. It’s more a question 


in my mind of whether this needs to be 


formalized or not. As Larry said, the 


perception in my mind is that we’ve seen a 


very careful use of surrogate data. I’d be 


surprised if our guidelines strayed from 


what’s been done in the past very much. 


DR. LOCKEY: This is Jim Lockey. From what 


Hans was saying, the various criteria that he 


was listing to me seemed to be really quite 


self evident and I would expect that that, in 


fact, is what’s going on. So if that’s what 


we’re sort of looking at and going back and 


making that a more formal written process or 


at least guidelines as such, I think that’s a 


reasonable approach to take. It seems logical 


that the guidelines, if that’s the approach 


that would have been taken rather than the 


same production year or same type of process, 


same type of manufacturing process, et cetera. 


MS. MUNN: Or at least reasonably --


DR. MELIUS: Yeah, with some general 

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59 

parameters on reasonable and so forth. And 


then I think it helps, but --


DR. LOCKEY: That’s what you’re talking 

about, Jim? 

DR. MELIUS: Yes. 

DR. LOCKEY: Okay, I think that’s --

MR. ELLIOTT: If I might, this is Larry 


Elliott again, Dr. Melius. If I could offer 


another comment here. Ancillary to this 


discussion is this working group I feel really 


needs to come to grips with, is the use of 


surrogate data allowed or not allowed. We 


have the Bethlehem Steel SEC evaluation before 


the Board and one hold on that is the outcome 


of your discussion on use of surrogate data. 


And at some point we really need to move that 


along, but we also need to come out with a 


collective consensus about the use of 


surrogate data. 


DR. MELIUS: I thought you were about to 


have Liz strike me with lightning again or 


something. You said allowed. No, I... 


MR. ELLIOTT: At NIOSH and at OCAS, we 


certainly feel that the law allows us, the 


regulations allow us to use it appropriately. 

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60 

But the perception on the outside is that 


that’s not read that way, or they don’t see it 


that way. And certainly in the Bethlehem 


Steel instance we’re tolling time on that 


evaluation for that petition. 


FUTURE PLANS
 

DR. MELIUS: No, I think we appreciate that 


issue. Let me talk about what I see as the 


way forward because I did try to promise 


everybody we would do this call within an 


hour. What I would like to do going forward 


propose is that I think everybody should take 


a look at the first, the September 12th report 


because I think it’s just a useful compendium 


and albeit whether everything’s completely 


characterized or whatever. I think aside from 


that it’s useful just, to me, sort of the 


breadth and different uses. It was helpful to 


me in sort of thinking about this issue. 


And then also again look at the second 


report and the three criteria. And if there 


are any sort of general suggestions or 


something that people would have about the 


other criteria, major criteria as opposed to 


sort of the checklist type of criteria. We’ll 

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61 

get to the more detailed criteria a little bit 


later. 


But I would propose is that people get 


back to me say within a couple of weeks with 


any comments or sort of general suggestions. 


I will work with SC&A to produce a sort of a 


draft general report that sort of be an 


outline and codify what we’ve been talking 


about today in the form of a draft report that 


would then circulate to the work group. 


And say that happens within say 


roughly three or four weeks from now. That 


then we would, I think either try to do a 


meeting or more likely a conference call given 


just the many work group meetings that are 


coming up and the holidays coming. I’m not 


sure that another meeting or something is 


going to be easy to do, but to have something 


for discussion and comments so that we can, 


maybe even by conference call spending a 


little bit longer, a few hours on this. And 


then see if we can have something ready to at 


least talk about with the full Board in the 


January meeting. 


DR. LOCKEY: This is Jim Lockey. I think 

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that’s fine. 


DR. MELIUS: And I will take the 


responsibility for doing a lot of the, writing 


an initial draft. I will get some input and 


help from John and his group to some extent on 


this. 


MS. MUNN: I have one suggestion with 


respect to our next steps. Is there any 


disagreement currently within the working 


group with respect to the reasonableness of 


using surrogate data for SECs? Aren’t we 


talking about putting together a document that 


is secondary to that issue? Have we not been 


discussing here an applicability that would 


move across both individual and SEC petitions? 


DR. MELIUS: At some level there I think we 


try to think of them as being related. That 


if something is, yeah. 


MS. MUNN: Yes, I do, too. 


DR. MELIUS: Yeah, okay. 


MS. MUNN: I guess my question is do we have 


any issues within the work group with respect 


to surrogate data being used in SECs. Does 


anyone disagree with that? 


DR. MELIUS: But they’re not used in SECs, 

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by definition. 


MR. ELLIOTT: This surrogate data goes to 


dose reconstruction. 


DR. MELIUS: Dose reconstruction. If it’s 


not feasible --


MR. ELLIOTT: If we can’t use surrogate data 


and that leads us to say we can’t do dose 


reconstruction, then we do an 8314 for a 


class. 


DR. MELIUS: I think what you’re asking, 


Wanda, is that if a dose constructions can 


only be done using surrogate data. 


MS. MUNN: Yeah. 


DR. MELIUS: I mean, I think it’s sort of 


the corollary of what you’re saying. And I 


think that, I think we have to sort of, I’d 


rather answer that question, at least I can’t 


answer that in a general sense, but I think 


that we would let’s produce an evaluation 


report and set a criteria and it’s applied 


appropriately. And whatever we have pending 


in terms of you know to the extent it’s 


helpful in your work group’s procedure review 


to the extent that it’s helpful in dealing 


with pending SECs and so forth, that’s fine. 

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64 

But I think we need to, I’d rather write a 


report that doesn’t try to think, specifically 


address particular instances. But rather 


let’s, what are the general criteria and then 


figure out how it applies. 


MS. MUNN: Yeah, I think we have to do the 


general criteria. 


DR. MELIUS: And do that in a timely fashion 


which Larry’s request, and I think that’s 


quite appropriate. 


DR. LOCKEY: Jim Melius, Jim Lockey. What 


about Larry’s question? That’s a question 


that we’re not going to be able to answer. 


What I hear is that that’s a legal question 


and Liz and group or whoever has to answer 


that question. Is that correct? 


DR. MELIUS: Yeah, but I think what Larry 


was really asking is can we get in a position 


where we would say that the use of surrogate 


data is technically appropriate in particular 


instances. And he obviously I think has, he 


said he had, he was thinking of the Bethlehem 


situation which is we do, I don’t know whether 


we tabled it or what our exact action was, but 

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65

 DR. WADE: We tabled it. 


DR. MELIUS: -- it’s contingent on us making 


progress on this particular issue. And I 


think that’s more what he was asking than the 


issue of --


DR. LOCKEY: Yes, it was. 


DR. MELIUS: -- appropriateness and -- and I 


hope Liz is still on the line. We’re not 


trying to address the legal issues. 


MS. HOMOKI-TITUS: Yes, I’m still here. I 


understand. 


DR. LOCKEY: So, Jim, at the end of this 


process when we put criteria down as to what 


Hans was saying, and then look at each one on 


a case-by-case basis and the process was 


followed, then the end result one would say, 


yes, in this case it is appropriate. The 


criteria are reasonable criteria. They follow 


general guidelines and using surrogate data 


under this situation is applicable. 


DR. MELIUS: Yeah. 


DR. LOCKEY: I was trying to figure where 


we’re going --


DR. MELIUS: Yeah, and then that’s exactly 


where we’re going. I think that’s what 

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Larry’s saying, you know, keep in mind that 


this has some practical or procedural 


implications, and we need to get on with it. 


But that’s in some extent what I’m trying to 


do. 


MS. MUNN: So do you have a feel for when 


you might be calling us back together? 


DR. MELIUS: Either the week before the 


Christmas holidays, or I’m suspecting more 


likely the week after New Year’s. 


MS. MUNN: Okay, the week after New Year’s 


we’re going to be in Las Vegas. 


DR. MELIUS: But the immediate week after --


MS. MUNN: Not the day after New Year’s. 


DR. MELIUS: Well, not the day after. 


MS. MUNN: Two days after New Year’s. 


DR. MELIUS: Well, someone was trying to 


convince me we’d do a conference call next 


Thursday on another issue. It also involves 


NIOSH by the way. 


MS. MUNN: Okay, so it’ll be a month. 


DR. MELIUS: Yes. 


MS. MUNN: We need not --


DR. MELIUS: Again, two weeks for people to 


get general comments to me on criteria and 

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then within a week or two after that I will, 


in working with SC&A, we will get the report, 


at least you’ll have the main, the general 


outline structure of the report. And we’ll 


undoubtedly need refinement and then input 


from everybody. 


MS. MUNN: Very good. Since I have not been 


keeping decent notes of the conversations 


we’ve been having here, it would be helpful if 


you’d send us an e-mail --


DR. MELIUS: I will. 


MS. MUNN: -- defining what you want from us 


and when you want it. 


DR. MELIUS: Okay, I’d be glad to. 


MS. MUNN: Thank you. 


DR. MELIUS: Other comments? Jim? 


DR. LOCKEY: No. 


DR. MELIUS: Mark, are you --


MR. GRIFFON: Still here and nothing to add 


though. I’m still here and nothing to add. 


DR. MELIUS: If we’ve done then I think we 


can close off. 


MR. ELLIOTT: Dr. Melius, this is Larry 


Elliott. Given what you’ve just decided here, 


does it still make sense I would ask to go 

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ahead with revealing and redacting the 


September 12th working paper or not? 


DR. MELIUS: Yes, I think it would simply, 


again, I’m just more comfortable having our 


documents publicly available. 


MR. ELLIOTT: That’s fine. 


DR. MELIUS: The nature of the document 


isn’t such that I don’t --


MR. ELLIOTT: I guess then that John will 


need to get that to Emily. 


DR. MELIUS: Yeah, right. 


 DR. WADE: Yeah, he said he would take that 


as an action. 


DR. MELIUS: Okay, thanks everybody. 


 DR. WADE: Thank you, very well done. 


MS. MUNN: Thank you. 


(Whereupon, the meeting was adjourned at 


3:23 p.m.) 

______________________________ 

69 

1 CERTIFICATE OF COURT REPORTER 


STATE OF GEORGIA 


COUNTY OF FULTON 


 I, Steven Ray Green, Certified Merit Court 


Reporter, do hereby certify that I reported the 


above and foregoing on the day of Nov. 16, 


2007; I, Steven Ray Green, then transcribed the 


proceedings, and it is a true and accurate 


transcript of the testimony captioned herein. 


 I further certify that I am neither kin 


nor counsel to any of the parties herein, nor 


have any interest in the cause named herein. 


 WITNESS my hand and official seal this the 


12th day of December, 2007. 


STEVEN RAY GREEN, CCR 


CERTIFIED MERIT COURT REPORTER 


CERTIFICATE NUMBER: A-2102